6008

Service Manual
Software version: ≥ 2.46
Edition: 11A-2022
Date of issue: 2022-05
Part no.: F50006537
0123
Table of contents

1 Index ........................................................................................................................................................ 11

2 Important information................................................................................................................. 17
2.1 How to use the Service Manual................................................................................................. 17
2.2 Significance of warnings ........................................................................................................... 18
2.3 Significance of notes ................................................................................................................. 18
2.4 Significance of tips..................................................................................................................... 19
2.5 Considerations for working on the device............................................................................... 19
2.6 Warnings ..................................................................................................................................... 22
2.6.1 Warnings about electrical safety................................................................................................... 22
2.7 Addresses ................................................................................................................................... 23

3 Installation .......................................................................................................................................... 25
3.1 Initial start-up.............................................................................................................................. 25
3.1.1 Important information on initial start-up ........................................................................................ 25
3.1.2 Initial start-up report...................................................................................................................... 26
3.1.3 Explanatory notes for completing the initial start-up report .......................................................... 30
3.2 Transporting the device............................................................................................................. 60
3.2.1 Relocation..................................................................................................................................... 60
3.2.2 Transport ...................................................................................................................................... 61
3.3 Disposal....................................................................................................................................... 64
3.3.1 Important information on disposal ................................................................................................ 64

4 Specifications ................................................................................................................................... 65
4.1 Dimensions and weight ............................................................................................................. 65
4.2 Identification label (device marking) ........................................................................................ 65
4.3 Electrical safety .......................................................................................................................... 66
4.4 Electrical power supply ............................................................................................................. 66
4.5 Fuses ........................................................................................................................................... 67
4.6 Information on electromagnetic compatibility
(IEC 60601-1-2:2014)................................................................................................................... 67
4.6.1 Minimum distances between radiation source and medical electrical equipment ........................ 67
4.6.2 Guidance and manufacturer's declaration on EMC ...................................................................... 69
4.7 Operating conditions ................................................................................................................. 70

Fresenius Medical Care 6008 SM-EN 11A-2022 3

 4.8 Consumption and energy data .................................................................................................. 71
4.9 Storage conditions ..................................................................................................................... 72
4.10 External connection options ..................................................................................................... 73
4.11 Operating programs ................................................................................................................... 74
4.12 Dialysate circuit and safety systems ........................................................................................ 76
4.13 Extracorporeal blood circuit and safety systems.................................................................... 79
4.14 DIASAFE® plus ........................................................................................................................... 81
4.15 OCM ............................................................................................................................................. 82
4.16 ONLINEplus™ ............................................................................................................................. 82
4.17 Network........................................................................................................................................ 84
4.18 Radio (option) – in monitor........................................................................................................ 85
4.19 Single-Needle (option)................................................................................................................ 85
4.20 VenAcc (option) monitoring unit............................................................................................... 85
4.21 BPM (option) ............................................................................................................................... 86
4.22 BTM (option)................................................................................................................................ 86
4.23 BVM (option) ............................................................................................................................... 87
4.24 Materials used............................................................................................................................. 88

5 Setup / service program............................................................................................................ 91

5.1 SYSTEM menu ............................................................................................................................ 91
5.1.1 Parameters in the SYSTEM menu................................................................................................ 92
5.2 SETUP menu (Service setup) .................................................................................................... 94
5.2.1 Settings Hydraulics menu option ............................................................................................... 95
5.2.2 Settings EBM menu option.......................................................................................................... 97
5.2.3 Settings Air bubble detector menu option................................................................................. 98
5.2.4 Define cleaning parameters menu option .................................................................................. 99
5.2.4.1 Define cleaning parameters menu option (page 1) ............................................... 99
5.2.4.2 Define cleaning parameters menu option (page 2) ............................................. 100
5.2.5 Miscellaneous menu option ...................................................................................................... 101
5.2.5.1 Installing additional languages ............................................................................... 102
5.2.6 Network menu option................................................................................................................. 103
5.2.6.1 Network menu option (page 1) .............................................................................. 103
5.2.6.2 Network menu option (page 2) .............................................................................. 104
5.2.6.3 Parameter Address ............................................................................................... 104
5.2.6.4 Reading the MAC address of the device................................................................ 104
5.2.7 BTM (option) menu option .......................................................................................................... 105
5.2.8 BVM (option) menu option.......................................................................................................... 105
5.2.9 Radio (option) menu option........................................................................................................ 105
5.2.10 AFM (option) menu option .......................................................................................................... 106
5.2.11 Software options menu option.................................................................................................. 106
5.3 USER SETUP menu .................................................................................................................. 108
5.3.1 Blood pump menu option .......................................................................................................... 109
5.3.2 Rinse / reinfusion volume menu option ................................................................................... 109
5.3.3 Anticoagulation menu option.................................................................................................... 110

4 Fresenius Medical Care 6008 SM-EN 11A-2022

 5.3.3.1 Define syringe types menu sub-item ................................................................... 111
5.3.4 Dialysate menu option ............................................................................................................... 112
5.3.4.1 Define concentrates menu sub-item .................................................................... 113
5.3.4.2 Installing additional concentrate lists...................................................................... 114
5.3.4.3 New concentrate menu sub-item.......................................................................... 115
5.3.5 Ultrafiltration menu option ........................................................................................................ 118
5.3.6 Alarm processing menu option ................................................................................................ 119
5.3.7 User interface menu option....................................................................................................... 121
5.3.7.1 Graphics menu sub-item....................................................................................... 121
5.3.7.2 Define options menu sub-item ............................................................................. 122
5.3.7.3 Define controls menu sub-item ............................................................................ 122
5.3.8 Cleaning menu option................................................................................................................ 123
5.3.9 Auto On menu option................................................................................................................. 124
5.3.10 Emergency menu option (reaction after selecting the Emergency field) ................................... 125
5.3.11 Extended safety menu option ................................................................................................... 126
5.3.12 ONLINE menu option ................................................................................................................. 126
5.3.12.1 Define dialyzers menu sub-item ........................................................................... 128
5.3.13 OCM menu option ...................................................................................................................... 128
5.3.14 Single-Needle (option) menu option.......................................................................................... 129
5.3.15 Miscellaneous menu option ...................................................................................................... 129
5.3.16 BPM (option) menu option.......................................................................................................... 130
5.3.17 BTM (option) menu option.......................................................................................................... 131
5.3.18 BVM (option) menu option.......................................................................................................... 131
5.3.19 SODIUM MGMT (option) menu option ....................................................................................... 132
5.3.20 LOW VOLUME (option) menu option......................................................................................... 132
5.3.21 VenAcc (option) menu option .................................................................................................... 133
5.4 APPLICATIONS menu .............................................................................................................. 133
5.4.1 PatientCard menu option........................................................................................................... 134
5.4.2 Training menu option................................................................................................................. 134
5.5 PC Service Software service program.................................................................................... 135
5.5.1 Matrix of the software versions of the PC Service Software....................................................... 135
5.5.2 Connection methods of the PC Service Software ...................................................................... 135
5.5.3 Quick Reference Guide for the PC Service Software................................................................. 136
5.5.3.1 Opening the Quick Reference Guide with the PC Service Software...................... 136
5.5.3.2 Opening the Quick Reference Guide from the installation CD............................... 136

6 Technical safety checks / maintenance procedures ......................................... 137

6.1 Important information on TSCs/MAs ...................................................................................... 137
6.2 Accessories required for the TSCs/MAs ................................................................................ 138
6.3 TSC/MA report .......................................................................................................................... 139
6.4 Explanatory notes for completing the TSC/MA report .......................................................... 144
6.5 TSC report ................................................................................................................................. 206

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7 Messages ........................................................................................................................................... 211

8 Test equipment and tools ...................................................................................................... 213

9 Calibration/Adjustment............................................................................................................ 221
9.1 SERVICE menu ......................................................................................................................... 221
9.2 Flow diagram menu .................................................................................................................. 222
9.2.1 Setting the maximum water inflow .............................................................................................. 222
9.3 EBM Flow Diagram ................................................................................................................... 224
9.3.1 EBM Flow Diagram without Single-Needle (option).................................................................... 225
9.3.2 EBM Flow Diagram with Single-Needle (option)......................................................................... 226
9.3.3 Description.................................................................................................................................. 227
9.4 CALIBRATE menu .................................................................................................................... 228
9.4.1 Calibrate touch screen menu option ........................................................................................ 228
9.4.2 Pressure transducer (S03/S07/S15/S16) menu option ............................................................ 229
9.4.3 Degassing (A02/P01) menu option ........................................................................................... 229
9.4.3.1 Loading pressure test menu sub-item ................................................................. 229
9.4.3.2 Negative pressure test menu sub-item ................................................................ 230
9.4.3.3 Start calibration menu sub-item ........................................................................... 230
9.4.3.4 Automatic calibration of the degassing pressure.................................................... 230
9.4.4 Flow pump (P03/A03) menu option........................................................................................... 231
9.4.5 Temperature (PT7/PT8/PT9) menu option ................................................................................ 232
9.4.6 Conductivity (CD7/CD9) menu option ...................................................................................... 233
9.4.7 Volumes menu option ................................................................................................................ 234
9.4.8 Blood leak menu option............................................................................................................. 234
9.4.8.1 Automatic calibration of the blood leak voltage ...................................................... 234
9.4.9 OCM menu option....................................................................................................................... 235
9.4.10 ECMP configuration menu option (eccentric membrane pumps)............................................. 236
9.4.11 Substituate unit menu option.................................................................................................... 237
9.4.12 Cassette sensors menu option ................................................................................................. 238
9.5 DIAGNOSTICS menu ................................................................................................................ 240
9.5.1 Monitor – Info menu option ....................................................................................................... 241
9.5.1.1 Checking the screen failure sensor ........................................................................ 241
9.5.2 EBM – Info menu option ............................................................................................................ 241
9.5.3 EBM – Test menu option............................................................................................................ 241
9.5.3.1 Performing the pneumatics test.............................................................................. 241
9.5.3.2 Performing the Single-Needle pneumatics test (option)......................................... 243
9.5.4 Hydraulics – Info menu option .................................................................................................. 245
9.5.5 Hydraulics – Flow diagram: Individual control menu option ................................................. 245
9.5.6 Hydraulics – Test menu option ................................................................................................. 246
9.5.7 Power supply unit – Info menu option ..................................................................................... 247
9.5.8 Radio – Info (option) menu option ............................................................................................. 248
9.5.9 BPM – Info / Test (option) menu option..................................................................................... 248
9.5.10 BVM – Info / Sensors (option) menu option .............................................................................. 249
9.5.10.1 Checking the BVM.................................................................................................. 249
9.5.11 BTM – Info / Sensors (option) menu option .............................................................................. 250
9.6 SETUP menu ............................................................................................................................. 250

6 Fresenius Medical Care 6008 SM-EN 11A-2022

 9.7 MODULE menu ......................................................................................................................... 250
9.7.1 Novram menu option ................................................................................................................. 250
9.8 VARIOUS menu......................................................................................................................... 251
9.8.1 Preservation menu option ......................................................................................................... 251
9.9 UPDATE menu .......................................................................................................................... 251
9.9.1 Updating the software version in a replaced module.................................................................. 251
9.9.2 Updating the software version of the device with a new CF card ............................................... 252
9.9.3 Updating the software version of the device with the PC Service Software ............................... 253
9.9.4 Software version of the operating system in the monitor (M1) ................................................... 254

10 Servicing/repair ............................................................................................................................. 255

10.1 Important information on servicing/repair ............................................................................. 255
10.2 Component overview ............................................................................................................... 256
10.2.1 Monitor........................................................................................................................................ 256
10.2.2 Extracorporeal Blood Circuit Module (EBM)............................................................................... 257
10.2.2.1 Front view............................................................................................................... 257
10.2.2.2 Front view (detail)................................................................................................... 258
10.2.2.3 Front view (door) .................................................................................................... 259
10.2.2.4 Rear view ............................................................................................................... 260
10.2.2.5 Actuator-sensor unit ............................................................................................... 261
10.2.3 Hydraulics................................................................................................................................... 263
10.2.3.1 Front view............................................................................................................... 263
10.2.3.2 Left side view ......................................................................................................... 264
10.2.3.3 Right side view ....................................................................................................... 265
10.2.3.4 Rear view ............................................................................................................... 266
10.2.3.5 Rear view with connectors ..................................................................................... 267
10.3 Basic procedures ..................................................................................................................... 268
10.3.1 Performing the T1 test ................................................................................................................ 268
10.3.2 Performing the EBM T1 test ....................................................................................................... 269
10.3.3 Measuring the protective earth resistance.................................................................................. 269
10.3.4 Measuring the device leakage current........................................................................................ 273
10.3.5 Laying the device on its back ..................................................................................................... 277
10.3.6 Installing components with SNAPLOC attachments................................................................... 277
10.3.7 Mounting components with self-cutting screws .......................................................................... 278
10.3.8 Closing and opening the tube clamp .......................................................................................... 278
10.3.9 Connecting the tubing to the adapter ......................................................................................... 280
10.4 Wrench torques ........................................................................................................................ 280
10.5 Tube clamps.............................................................................................................................. 282
10.6 Housing ..................................................................................................................................... 283
10.6.1 Removing and installing the IV pole ........................................................................................... 283
10.6.2 Removing and installing the shunt interlock ............................................................................... 283
10.6.3 Removing and installing the microswitch in the installed shunt interlock ................................... 286
10.6.4 Removing and installing the shunt interlock mark ...................................................................... 287
10.6.5 Removing and installing the dialyzer coupling............................................................................ 287
10.6.6 Removing and installing the dialyzer holder ............................................................................... 288
10.6.7 Removing and installing the blood pressure monitor (BPM) (option) ......................................... 289
10.6.8 Opening and closing the media supply rail................................................................................. 290
10.6.9 Opening and closing the side panel ........................................................................................... 291
10.6.10 Removing and installing the positioning handles (option) .......................................................... 292

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 10.7 Cart............................................................................................................................................. 294
10.7.1 Removing and installing the concentrate container holder ......................................................... 294
10.7.2 Removing and installing the braking mechanism ....................................................................... 294
10.8 Rechargeable batteries ............................................................................................................ 296
10.8.1 Removing and installing the rechargeable battery pack ............................................................. 296
10.9 Monitor....................................................................................................................................... 297
10.9.1 Locking and releasing the monitor support arm.......................................................................... 297
10.9.2 Opening and closing the monitor ................................................................................................ 298
10.9.3 Adjusting monitor axes ............................................................................................................... 299
10.9.3.1 Adjusting monitor axis 1 ......................................................................................... 300
10.9.3.2 Adjusting monitor axis 2 ......................................................................................... 300
10.9.3.3 Adjusting monitor axis 3 ......................................................................................... 301
10.9.4 Monitor matrices ......................................................................................................................... 302
10.9.4.1 Matrix for selecting spare parts .............................................................................. 302
10.9.4.2 Monitor compatibility matrix.................................................................................... 305
10.9.5 Removing and installing monitor front with screen ..................................................................... 305
10.9.6 Removing and installing monitor front ........................................................................................ 308
10.9.7 Removing and installing the screen with mounting frame .......................................................... 310
10.9.8 Removing and installing the monitor rear with monitor support arm........................................... 313
10.10 Power supply unit and power supply cord ............................................................................ 318
10.10.1 Removing and installing the power supply cord ......................................................................... 318
10.10.2 Removing and installing the power supply unit........................................................................... 318
10.10.3 Removing and installing the power plug fuse (UK version only)................................................. 321
10.11 Extracorporeal Blood Circuit Module (EBM).......................................................................... 322
10.11.1 Door ............................................................................................................................................ 322
10.11.1.1 Replacing the screw protection caps...................................................................... 322
10.11.1.2 Removing and installing the design hood............................................................... 322
10.11.1.3 Removing and installing the door bolt .................................................................... 323
10.11.1.4 Removing and installing the cassette deaeration port/Single-Needle port or
cassette coupling port ............................................................................................ 325
10.11.1.5 Removing and installing PCB LP 1179 LED board ................................................ 327
10.11.2 Opening and closing the EBM .................................................................................................... 328
10.11.3 Removing and installing the EBM............................................................................................... 328
10.11.4 Replacing the pneumatic tubings in the EBM ............................................................................. 334
10.11.5 Removing and installing the arterial occlusion clamp ................................................................. 335
10.11.6 Removing and installing the venous occlusion clamp ................................................................ 337
10.11.7 Resetting the zero point of the pressure transducers (EBM)...................................................... 340
10.11.8 Measuring the zero points of the pressure transducers (EBM) .................................................. 340
10.11.9 Removing and installing the substituate unit .............................................................................. 341
10.11.10 Actuator-sensor unit.................................................................................................................... 344
10.11.10.1 Removing and installing the cassette contact mat ................................................. 344
10.11.10.2 Removing and installing the temperature sensor ................................................... 349
10.11.10.3 Removing and installing the supports of the cassette contact mat ........................ 349
10.11.10.4 Removing and installing level detector................................................................... 351
10.11.10.5 Removing and installing the cassette coupling sensor........................................... 353
10.11.10.6 Removing and installing the cassette detection sensors........................................ 355
10.11.10.7 Removing and installing the pressure transducer .................................................. 357
10.11.10.8 Removing and installing the actuator-sensor unit .................................................. 362
10.11.11 Removing and installing the pneumatic unit ............................................................................... 368
10.11.12 Removing and installing the drawbar.......................................................................................... 369
10.11.13 Removing and installing the door lock Hall sensor ..................................................................... 374
10.11.14 Removing and installing the pressure actuator........................................................................... 375
10.11.15 Removing and installing the pressure vessel ............................................................................. 377
10.11.16 Checking and repair in case of blood or fluid ingress via the pneumatic connections................ 379

8 Fresenius Medical Care 6008 SM-EN 11A-2022

 10.11.17 Removing and installing the emergency unlocking mechanism ................................................. 381
10.11.18 Removing and installing the catch of the occlusion clamps ....................................................... 382
10.11.19 Removing and installing the optical detector / air bubble detector (ABD) .................................. 383
10.11.20 Heparin pump ............................................................................................................................. 385
10.11.20.1 Removing and installing the heparin pump grip handle ......................................... 385
10.11.20.2 Removing and installing the heparin pump length sensor ..................................... 388
10.11.20.3 Removing and installing the heparin pump ............................................................ 390
10.11.21 Removing and installing the rinse port ....................................................................................... 394
10.11.22 Removing and installing the air feeding unit V42 ....................................................................... 396
10.11.23 Removing and installing the rotor ............................................................................................... 397
10.11.24 Removing and installing the rotor brake ..................................................................................... 398
10.11.25 Removing and installing the blood and substituate pump drives................................................ 400
10.11.26 Single-Needle (option)................................................................................................................ 402
10.11.26.1 Removing and installing the Single-Needle air expansion tank (option) ................ 402
10.11.26.2 Removing and installing the Single-Needle unit (option) ....................................... 403
10.11.26.3 Removing and installing the Single-Needle condensate separator (option) .......... 404
10.11.27 Removing and installing the blood temperature monitor (BTM) (option) .................................... 407
10.11.28 Removing and installing the blood volume monitor (BVM) (option)............................................ 408
10.12 Hydraulics ................................................................................................................................. 411
10.12.1 Removing and installing the pressure reducing valve A04, water inlet ...................................... 411
10.12.2 Removing and installing the water inlet block............................................................................. 411
10.12.3 Removing and installing the heat exchanger.............................................................................. 413
10.12.4 Removing and installing the float switch S01 of the water inlet chamber................................... 415
10.12.5 Removing and installing the degassing orifice ........................................................................... 418
10.12.6 Removing and installing the heater rod ...................................................................................... 419
10.12.7 Removing and installing the concentrate pump.......................................................................... 421
10.12.8 Removing and installing the bicarbonate pump.......................................................................... 422
10.12.9 Removing and installing the UF pump........................................................................................ 423
10.12.10 Removing and installing the gear pump drive ............................................................................ 424
10.12.11 Removing and installing the gear pump ..................................................................................... 425
10.12.12 Removing and installing the balancing chamber ........................................................................ 426
10.12.13 Removing and installing the blood leak detector ........................................................................ 427
10.12.14 Removing and installing the flap lid ............................................................................................ 430
10.12.15 Removing and installing the bibag connector............................................................................. 431
10.12.16 Removing and installing the concentrate rinse chamber............................................................ 432
10.12.17 Removing and installing the bicarbonate rinse chamber............................................................ 435
10.12.18 Removing and installing the CDS block ..................................................................................... 436
10.12.18.1 Vent valve of CDS block ........................................................................................ 438
10.12.19 Removing and installing the pressure transducer ...................................................................... 439
10.12.20 Removing and installing the temperature sensor ....................................................................... 440
10.12.21 Removing and installing the conductivity sensor........................................................................ 441
10.12.22 Removing and installing the disinfectant valve V20 ................................................................... 441
10.12.23 Removing and installing the disinfectant valve V34 ................................................................... 443
10.12.24 Deactivating the Flush function .................................................................................................. 445
10.13 Checking the network interface .............................................................................................. 447
10.14 Printed circuit boards .............................................................................................................. 449
10.14.1 PCB LP 1104 Monitor power supply board ................................................................................ 449
10.14.2 PCB LP 1105-1 Power supply CPU (serial number section VMA) ............................................. 451
10.14.3 PCB LP 1106 Power supply distribution board........................................................................... 452
10.14.4 PCB LP 1126 Heparin pump control board ................................................................................ 454
10.14.5 PCB LP 1131 Monitor operating mode indicator ........................................................................ 455
10.14.6 PCB LP 1131-2 Monitor operating mode indicator with wireless module................................... 456
10.14.7 PCB LP 1134 Monitor card reader ............................................................................................. 457
10.14.8 PCB LP 1140 Hydraulic sensors ................................................................................................ 458

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 10.14.9 PCB LP 1141-3 Hydraulics actuators ......................................................................................... 460
10.14.10 PCB LP 1142 External I/O board................................................................................................ 462
10.14.11 PCB LP 1145-1 Monitor distribution board ................................................................................. 465
10.14.12 PCB LP 1150 Screen failure sensor ........................................................................................... 467
10.14.13 PCB LP 1178 I/O board .............................................................................................................. 468
10.14.14 PCB LP 1179 LED board............................................................................................................ 470
10.14.15 PCB LP 1180 SN tank ................................................................................................................ 471
10.14.16 PCB LP 1186 Power supply CPU (serial number section WMT)................................................ 472
10.14.17 PCB LP 1202-3 Controller board (C167) .................................................................................... 473
10.14.18 PC board..................................................................................................................................... 475
10.15 Troubleshooting ....................................................................................................................... 477
10.15.1 Troubleshooting with dark display .............................................................................................. 477
10.15.2 Troubleshooting in case of unclear crashes and suspected CAN bus problems........................ 479
10.15.3 Example pictures of improperly installed cassette contact mats ................................................ 484

11 Functional description ............................................................................................................. 487

11.1 Complete system ...................................................................................................................... 487
11.2 Overview of PCBs..................................................................................................................... 488
11.3 Monitor....................................................................................................................................... 489
11.4 Power supply unit..................................................................................................................... 491
11.5 Extracorporeal Blood Circuit Module (EBM).......................................................................... 494
11.6 Pneumatics................................................................................................................................ 496
11.6.1 Pneumatics overview with current version of pneumatic unit (injection-molded part) ................ 498
11.6.2 Pneumatics overview with preceding version of pneumatic unit (milled part)............................. 500
11.7 Hydraulics (block diagram / description) ............................................................................... 502
11.8 Hydraulics (flow diagram, legend, description)..................................................................... 504

12 Appendix ............................................................................................................................................ 509

12.1 Information on electromagnetic compatibility
(IEC 60601-1-2:2007)................................................................................................................. 509
12.1.1 Minimum distances between radiation source and medical electrical equipment ...................... 509
12.1.2 Guidance and manufacturer's declaration on EMC .................................................................... 511

10 Fresenius Medical Care 6008 SM-EN 11A-2022

 Chapter 1: Index

1 Index
A Bicarbonate pump, removing and – Cassette sensors 238
installing 422 – Conductivity (CD7/CD9) 233
Accessories and test equipment – Degassing (A02/P01) 229
Bicarbonate rinse chamber,
213 – ECMP configuration 236
removing and installing 435
Accessories required – Flow pump (A03) 231
– TSCs and MAs 138 Block diagram
– Pressure transducer
– Monitor 489
Actuator-sensor unit, removing (S03/S07/S15/S16) 229
and installing 362 Block diagrams – Substituate unit 237
– EBM flow diagram with Single- – Temperature (PT7/PT8/PT9)
Addresses 23 Needle (option) 226 232
Adjusting – EBM flow diagram without – Volumes 234
– Monitor axis 1 300 Single-Needle (option) 225
Calibration 221
– Monitor axis 2 300 – Hydraulics 502
– Monitor axis 3 301 – Pneumatics 496 CALIBRATION menu
– Power supply unit (PCB – OCM 235
Adjustment 221
LP1105-1) 491 Cart 294
Air bubble detector 80
– Power supply unit (PCB Cassette contact mat, removing
Air bubble detector (ABD), LP1186) 492 and installing 344
removing and installing 383
Blood and substituate pump Cassette coupling port, removing
Air feeding unit V42, removing and drives, removing and installing 400 and installing 325
installing 396
Blood flow 79 Cassette coupling sensor,
Alarm output 74
Blood ingress 379 removing and installing 353
APPLICATIONS menu 133
Blood leak detector 76 Cassette deaeration port,
– PatientCard 134
Blood leak detector, removing and removing and installing 325
– Training 134
installing 427 Cassette detection sensor,
AquaUNO/AquaCUNOH 73
Blood pressure monitor (BPM) 86 removing and installing 355
Arterial occlusion clamp, removing
and installing 335 Blood pressure monitor (BPM) Catch of the occlusion clamps,
(option), removing and installing removing and installing 382
Arterial pressure measurement 79
289 CDS block, removing and
Atmospheric pressure 70 installing 436
Blood volume monitor (BVM)
Audible alarm 81 (option), removing and installing Central delivery system (option) 71
Authorized persons 19 408 Checking the BVM (option) 249
AutoFlow 78 BPM (option) Checking/repair for blood/fluid
– BPM version 190 ingress 379
– BPM2 version 190
B Circulation 75
BPM version 190
Balancing chamber, removing and Cleaning programs 75
BPM2 version 190
installing 426 Closing plugs 218
Braking mechanism, removing and
Basic procedures 268 Component overview
installing 294
Batteries – EBM 257
BTM (option) 86 – Hydraulics 263
– PC board 475
– PCB LP1105-1 451 BVM (option) 87 – Monitor 256
– PCB LP1186 472 – Checking 249 Concentrate container holder,
– TSC/MA 178, 179 removing and installing 294
– VenAcc (option) 85 C Concentrate pump, removing and
Battery pack, removing and installing 421
installing 296 CALIBRATE menu 228
– Blood leak 234 Concentrate rinse chamber,
bibag connector, removing and – Calibrate touch screen 228 removing and installing 432
installing 431 Concentration of disinfectant 79

Fresenius Medical Care 6008 SM-EN 11A-2022 11

Chapter 1: Index

Conductivity sensor, removing and Disinfectant valve V20, removing – electromagnetic immunity 69
installing 441 and installing 441 – Guidance and manufacturer's
Connecting the tubing to the Disinfectant valve V34, removing declaration 69
adapter 280 and installing 443 – Minimum distances between
radiation source and device 67
Considerations for working on the Disposal
device 19 – Important information 64 Emergency unlocking mechanism,
removing and installing 381
Consumption data 71 Door 259
– Design hood, removing and Energy data 71
Converting g/l to mmol/l 118
installing 322 ESD precautions 20
– Door bolt, removing and Example pictures of improperly
D installing 323 installed cassette contact mats
Deactivating Flush (option) 445 – Screw protection caps, 484
replacing 322
Degassing orifice, removing and Explanatory notes
installing 418 Door bolt, removing and installing – Initial start-up report 30
323 – TSC report 144
Descriptions
– EBM 227 Door lock Hall sensor, removing – TSC/MA report 144
– Hydraulics 503, 506 and installing 374 External connection options 73
– Monitor 490 Door screw protection caps, Extracorporeal Blood Circuit
– Pneumatics 501 replacing 322 Module (EBM) 322
– Power supply unit 493 Drawbar, removing and installing
Design hood, removing and 369
installing 322
F
Device, tilting 277 Final tasks after working on the
E device 21
DIAGNOSTICS menu 240
EBM Flap lid, removing and installing
– BPM – Info / Test (option) 248
– Description 227 430
– BTM – Info / Sensors (option)
– EBM flow diagram with Single-
250 Float switch S01 of the water inlet
Needle (option) 226
– BVM – Info / Sensors (option) chamber, removing and installing
– EBM flow diagram without
249 415
Single-Needle (option) 225
– EBM – Info 241 Flow diagram
– Opening and closing 328
– EBM – Test 241 – Description 506
– Removing and installing 328
– Hydraulics – Flow diagram – Legend 505
– Zero point of the pressure
Individual control 245 transducers, measuring 340 Flow diagram menu 222
– Hydraulics – Info 245 – Zero point of the pressure Flush (option) 445
– Hydraulics – Test 246 transducers, resetting 340
– Monitor – Info 241 Functional description 487
EcoFlow 78
– PSU – Info 247 Fuses 67
– Radio – Info (option) 248 Electrical power supply 66 – Power plug fuse, UK version
Dialysate circuit and safety Electrical safety 66 321
systems 76 – Measuring the device leakage – Power switch 67
Dialysis water inlet pressure 71
current 273 – Rechargeable battery 67, 266
– Measuring the protective earth – TSC/MA 145
Dialysis water inlet rate 71 resistance 269
Dialysis water inlet temperature 71 Electromagnetic compatibility (IEC
Dialyzer coupling, removing and
G
60601-1-2:2007) 509
installing 287 Electromagnetic compatibility (IEC Gear pump drive, removing and
Dialyzer holder, removing and 60601-1-2:2014) 67 installing 424
installing 288 EMC Gear pump, removing and
DIASAFE®plus 81 – Electromagnetic compatibility installing 425
Dimensions of the device 65 (IEC 60601-1-2:2007) 509
Direction of rotation of manual – Electromagnetic compatibility H
blood return 257 (IEC 60601-1-2:2014) 67
– electromagnetic emissions 69 Hand crank 266

12 Fresenius Medical Care 6008 SM-EN 11A-2022

 Chapter 1: Index

Heat exchanger, removing and M ONLINEplus™ 82

installing 413 Opening and closing the media
Maintenance procedures (MAs)
Heater rod, removing and supply rail 290
137
installing 419 Opening and closing the side
Manufacturer 23
Heparin pump 81 panel 291
Materials 88
Heparin pump grip handle, Operating conditions 70, 510
removing and installing 385 Materials used 88
Operating programs 74
Heparin pump length sensor, Matrix for selecting spare parts
Operating temperature range 71
removing and installing 388 302
Maximum water inflow, setting 222 Optical detector 80
Heparin pump, removing and
Measuring the device leakage Optical detector, removing and
installing 390
current 273 installing 383
Housing 283
How to use the Service Manual 17 Measuring the protective earth
resistance 269 P
Hydraulics 263
– Block diagram 502 Measuring the zero points of the PC board
– Description 503, 506 pressure transducers (EBM) 340 – Batteries 475
– Flow diagram 504 Messages 211 – Calibration 476
– Legend 505 Microswitch in the installed shunt – Check 476
interlock, removing and installing – Connectors 475
286 – Final tasks 476
I – Installation location 476
MODULE menu 250
Identification label 65 – Novram 250 PC Service Software 135
Illustrations 18 Monitor PCB LP1104
Important information 17 – Block diagram 489 – Calibration 450
– Disposal 64 – Description 490 – Check 450
– Initial start-up 25 – Connectors 449
Monitor axis 1, adjusting 300
– Repair 255 – Final tasks 450
Monitor axis 2, adjusting 300 – Fuses 449
– Servicing 255
– TSCs 137 Monitor axis 3, adjusting 301 – Installation location 450
– TSCs and MAs 137 Monitor compatibility matrix 305 – Jumpers 449
– LEDs 449
Inclination during operation 70 Monitor front with screen,
– Other 449
Ingress of fluid 379 removing and installing 305
– Solder bridges 305, 449
Initial start-up Monitor front, removing and PCB LP1105-1
– Explanatory notes 30 installing 308 – Batteries 451
– Important information 25 Monitor matrices 302 – Calibration 451
– Report 27 Monitor operating system (M1) – Check 451
Installation altitude 70 254 – Connectors 451
IV pole 70 Monitor rear with monitor support – Final tasks 451
arm, removing and installing 313 – Installation location 451
IV pole, removing and installing
– LEDs 451
283 Monitor, adjusting axes 299
– Measurement points 451
Monitor, opening and closing 298
PCB LP1106
L – Calibration 452
LAN 73 N – Check 452
– Connectors 452
Laying the device on its back 277 Network 84 – Final tasks 452
Level detector, removing and Network interface, checking 447 – Fuses 452
installing 351 Note symbol, significance 18 – Installation location 452
Locking and releasing the monitor PCB LP1126
support arm 297 – Calibration 454
O – Check 454
OCM 82 – Connectors 454

Fresenius Medical Care 6008 SM-EN 11A-2022 13

Chapter 1: Index

– Final tasks 454 – Check 467 – Description 501

– Installation location 454 – Connectors 467 – Legend 497
PCB LP1131 – Final tasks 467 – Pneumatics circuit diagram 496
– Calibration 455 – Installation location 467 Pneumatics circuit diagram 496
– Check 455 PCB LP1178 Positioning handles (option),
– Connectors 455 – Calibration 469 removing and installing 292
– Final tasks 455 – Check 469
Power supply cord, removing and
– Installation location 455 – Connectors 468
installing 318
– LEDs 455 – Final tasks 469
– Fuses 468 Power supply unit
PCB LP1131-2
– Installation location 468 – Block diagram (PCB LP1105-1)
– Calibration 456
– Jumpers 468 491
– Check 456
– LEDs 468 – Block diagram (PCB LP1186)
– Connectors 456
492
– Final tasks 456 PCB LP1179
– Description 493
– Installation location 456 – Calibration 470
– LEDs 456 – Check 470 Power supply unit, removing and
– Connectors 470 installing 318
PCB LP1134
– Calibration 457 – Final tasks 470 Precautions 19
– Check 457 – Installation location 470 Preparation 74
– Connectors 457 – LEDs 470
Pressure actuator, removing and
– Final tasks 457 PCB LP1180 installing 375
– Installation location 457 – Calibration 471
Pressure holding test 76
PCB LP1140 – Check 471
– Connectors 471 Pressure reducing valve A04,
– Calibration 459
– Final tasks 471 water inlet, removing and installing
– Check 459
– Installation location 471 411
– Final tasks 459
– Installation location 458 – Sensors 471 Pressure transducer (EBM),
PCB LP1186 removing and installing 357
PCB LP1141-3
– Calibration 460 – Batteries 472 Pressure transducer (hydraulics),
– Check 460 – Calibration 472 removing and installing 439
– Connectors 460 – Check 472 Pressure vessel, removing and
– Final tasks 461 – Connectors 472 installing 377
– Fuses 460 – Final tasks 472
Priming and rinsing 74
– Installation location 460 – Installation location 472
Printed circuit boards 449
– Jumpers 460 PCB LP1202-3
– PC board 475
– LEDs 460 – Calibration 474
– PCB LP1104 449
PCB LP1142 – Check 474
– PCB LP1105-1 451
– Calibration 462 – Connectors 473
– PCB LP1106 452
– Check 464 – Final tasks 474
– PCB LP1126 454
– Connectors 462 – Installation locations 473
– PCB LP1131 455
– Final tasks 464 – LEDs 473
– PCB LP1131-2 (wireless
– Fuses 462 – Monitor safety system M2,
module) 456
– Installation location 462 copying 473
– PCB LP1134 457
– Jumpers 462 PCBs – PCB LP1140 458
– Nurse call, configuring 462 – Overview of PCBs 488 – PCB LP1141-3 460
PCB LP1145-1 PCBs, overview 488 – PCB LP1142 462
– Calibration 466 Performing the EBM T1 test 269 – PCB LP1145-1 465
– Check 465 – PCB LP1150 467
Performing the T1 test 268
– Connectors 465 – PCB LP1178 468
– Final tasks 466 Pneumatic tubings in the EBM, – PCB LP1179 470
– Installation location 465 replacing 334 – PCB LP1180 471
– Potentiometers 465 Pneumatic unit, removing and – PCB LP1186 472
PCB LP1150 installing 368 – PCB LP1202-3 473
– Calibration 467 Pneumatics Pulse 86

14 Fresenius Medical Care 6008 SM-EN 11A-2022

 Chapter 1: Index

R – Drawbar 369 – Venous occlusion clamp 337

– EBM 328 – Water inlet block 411
Rechargeable battery – Flap lid 430 Removing and installing PCB
– Fuse 67 – Float switch S01 415 LP1179 LED board 327
– maintenance 72 – Gear pump 425
– Removing and installing 296 Removing and installing the blood
– Gear pump drive 424
– Specifications 66 temperature monitor (BTM)
– Heat exchanger 413
– TSC/MA 177 (option) 407
– Heater rod 419
– Voltage 66, 247 – Heparin pump 390 Removing and installing the power
Reinfusion 75 – Heparin pump grip handle 385 plug fuse (UK version only) 321
Relative humidity 70 – Heparin pump length sensor Removing and installing the
Relocation 60 388 Single-Needle air expansion tank
– IV pole 283 (option) 402
Removing and installing – Level detector 351
– Actuator-sensor unit 362 Replacing the screw protection
– Monitor front 308 caps 322
– Air bubble detector (ABD) 383 – Monitor front with screen 305
– Air feeding unit V42 396 Reports
– Monitor rear with monitor
– Arterial occlusion clamp 335 – Initial start-up 27
support arm 313
– Balancing chamber 426 – TSC 207
– Optical detector 383
– Battery pack 296 – TSC/MA 140
– Pneumatic tubings in the EBM
– bibag connector 431 334 Resetting the zero point of the
– Bicarbonate pump 422 – Pneumatic unit 368 pressure transducers (EBM) 340
– Bicarbonate rinse chamber 435 – Positioning handles (option) Rinse and disinfection flow 79
– Blood and substituate pump 292
drives 400 Rinse port, removing and installing
– Power plug fuse (UK version 394
– Blood leak detector 427 only) 321
– Blood pressure monitor (BPM) Rotor brake, removing and
– Power supply cord 318
(option) 289 installing 398
– Power supply unit 318
– Blood temperature monitor – Pressure actuator 375 Rotor, removing and installing 397
(BTM) (option) 407 – Pressure reducing valve A04
– Blood volume monitor (BVM) 411
(option) 408 S
– Pressure transducer (EBM)
– Braking mechanism 294 357 Screen, removing and installing
– Cassette contact mat 344 – Pressure transducer 310
– Cassette coupling port 325 (hydraulics) 439 Self-tapping screws 278
– Cassette coupling sensor 353 – Pressure vessel 377
– Cassette deaeration port 325 SERVICE menu 221
– Rinse port 394 – CALIBRATE 228
– Cassette detection sensors – Rotor 397
355 – DIAGNOSTICS 240
– Rotor brake 398 – Flow diagram 222
– Catch of the occlusion clamps – Screen 310
382 – MODULE 250
– Screw protection caps 322 – SETUP 94
– CDS block 436 – Shunt interlock 283
– Concentrate container holder – UPDATE 251
– Shunt interlock mark 287 – VARIOUS 251
294 – Shunt interlock microswitch
– Concentrate pump 421 Service program 135
286
– Concentrate rinse chamber – Single-Needle air expansion Service/diagnostics 73
432 tank (option) 402 Setup / service program 91
– Conductivity sensor 441 – Single-Needle condensate
– Degassing orifice 418 SETUP menu (Service setup) 94
separator (option) 404 – AFM (option) 106
– Design hood 322 – Single-Needle port 325
– Dialyzer coupling 287 – BTM (option) 105
– Single-Needle unit (option) 403 – BVM (option) 105
– Dialyzer holder 288 – Substituate unit 341
– Disinfectant valve V20 441 – Define cleaning parameters 99
– Supports of the cassette – Miscellaneous 101
– Disinfectant valve V34 443 contact mat 349
– Door bolt 323 – Network 103
– Temperature sensor 349, 440 – Radio (option) 105
– Door lock Hall sensor 374 – UF pump 423 – Settings Air bubble detector 98

Fresenius Medical Care 6008 SM-EN 11A-2022 15

Chapter 1: Index

– Settings EBM 97 Troubleshooting in case of unclear – Rinse / reinfusion volume 109

– Settings Hydraulics 95 crashes and suspected CAN bus – Single-Needle (option) 129
– Software options 106 problems 479 – SODIUM MGMT (option) 132
Shunt interlock mark, removing Troubleshooting with dark display – Ultrafiltration 118
and installing 287 477 – User interface 121
– VenAcc (option) 133
Shunt interlock, removing and TSC
installing 283 – Explanatory notes for
Single-Needle (option) 85 completing the report 144 V
– Report 207
Single-Needle condensate VARIOUS menu 251
separator (option), removing and TSC/MA – Preservation 251
installing 404 – Explanatory notes for
completing the report 144 Venous occlusion clamp,
Single-Needle port, removing and removing and installing 337
– Report 140
installing 325 Venous pressure measurement 80
TSCs
Single-Needle unit (option), Vent valve of CDS block 438
– Accessories required 138
removing and installing 403
– Important information 137
SNAPLOC attachment 277
Software version of the operating
TSCs and MAs W
– Accessories required 138
system in the monitor (M1) 254 – Important information 137 Warning symbol, significance 18
Spare parts 21 Tube clamp, closing and opening Warnings about electrical safety
Specifications 65 278 22
Stability 70 Tube clamps 282 Water drain 71
Stopping a disinfection program 20 Water inlet block, removing and
installing 411
Storage conditions 72 U Weight of the device 65
Styles used in the document 17 UF pump, removing and installing Working on the device 21
Substituate unit, removing and 423
installing 341 Wrench torques 280
UFC measurement 77
Supports of the cassette contact Ultrafiltration 76
mat, removing and installing 349
UPDATE menu 251
Z
System installer 84 Zero points of pressure transducer
Updating the software version 251
SYSTEM menu 91 – in a replaced module 251 340
– APPLICATIONS 133 – with a new CF card 252
– SERVICE 221 – with the PC Service Software
– USER SETUP 108 253
USER SETUP menu 108
T – Alarm processing 119
– Anticoagulation 110
T1 test 74
– Auto On 124
Technical safety checks (TSCs) – Blood pump 109
137 – BPM (option) 130
Temperature at water drain 71 – BTM (option) 131
Temperature sensor, removing – BVM (option) 131
and installing 349, 440 – Cleaning 123
– Define concentrates 113
Test equipment and tools 213
– Dialysate 112
Tilting tool 220 – Emergency 125
Tip symbol, significance 19 – Extended safety 126
Transport 61 – LOW VOLUME (option) 132
– Miscellaneous 129
Treatment 74
– New concentrate 115
– OCM 128
– ONLINE 126

16 Fresenius Medical Care 6008 SM-EN 11A-2022

 Chapter 2: Important information

2 Important information

2.1 How to use the Service Manual

Device type In this document, unless otherwise stated, the word "device" on its own
always refers to the 6008 device.

Purpose This document is intended for service technicians and is to be used for
first studies (to acquire a basic knowledge) and for reference purposes
(for technical safety checks, maintenance and repair). The document
does not replace the training courses offered by the manufacturer.

Identification The document can be identified by the following information on the title
page and on the labels, if any:
– Document edition
– Part number of the document

Footer The footer displays the following information:

– Company name
– Device type
– The English abbreviation for the document type and the international
abbreviation for the document language, e.g., SM-EN means
Service Manual in English.
– The edition, for example, 11A-2017 refers to edition 11A released in
2017
– Page identification

Organization of the To facilitate the use of documents from Fresenius Medical Care, the
chapters organization of the chapters has been standardized in all manuals.
There may therefore be chapters within this document without any
content. Chapters without content are marked accordingly.

Styles used in the The following text styles may be used in the document:
document
Style Description

Keys/buttons or Keys, buttons and fields on the device are

fields shown in bold type.
Example: Example button.

Message text Device messages are shown in italic type.

Example: Message: Example of a message.

 Instruction Instructions are indicated by an arrow .

Instructions must be followed.
Example:  Carry out instruction.

Fresenius Medical Care 6008 SM-EN 11A-2022 17

Chapter 2: Important information

Style Description

1. Numbered Long passages containing instructions can

instruction be shown as numbered lists. Instructions
must be followed.
2. ...
Example: 1. Carry out instruction.
3. ...

Illustrations The illustrations used in the documents may differ from the original if
this does not have any influence on the function.

Changes Changes to the documents will be released as new editions or

supplements. In general, this manual is subject to change without
notice.

Reproduction Reproduction, even in part, is only permitted with written approval.

2.2 Significance of warnings

Advises the operator of hazards that carry the risk of serious to

potentially life-threatening personal injury, unless the measures for
avoiding the risk described are followed.

Warning
Type and cause of risk
Possible consequences of exposure to the risk.
 Measures for avoiding the risk.

Warnings can deviate from the above template in the following cases:
– If a warning describes several risks
– If no specific risks can be detailed in the warning

2.3 Significance of notes

Note
Advises the operator that failure to observe this information can result
in the following:
– Damage to the device
– Required functions will not be executed at all or not executed
correctly

18 Fresenius Medical Care 6008 SM-EN 11A-2022

 Chapter 2: Important information

2.4 Significance of tips

Tip
Information providing useful tips for easy handling.

2.5 Considerations for working on the device

Requirements Knowledge of the current Instructions for Use of the respective device.
Experience in mechanical engineering, electrical engineering, and
medical technology.

Authorized persons
Warning
Risk of injury for the patient and operator as a result of improper
servicing performed on the device
Improper servicing can impair the safe functioning of the device.
 Only allow the manufacturer or persons authorized by the
manufacturer to perform start-up, extensions, adjustments,
calibrations, maintenance procedures, modifications or repairs.

Test equipment and tools The activities described in this document require the availability of the
necessary technical test equipment and tools.

Specifications The information contained in the Specifications chapter must be

observed.

Precautions Before switching on the power, repair any visible damage.

Before opening the device and when working on the open device, the
following precautions must be observed:
– Protect the components against ingress of fluids.
– There is a risk of chemical burns and scalding when working on the
hydraulics.
– Do not touch live parts.
– Plugs, connections and components must only be disconnected or
connected when the device is switched off.
– There is a risk of injury on parts with corners and edges.

Fresenius Medical Care 6008 SM-EN 11A-2022 19

Chapter 2: Important information

Warning
Risk of cross-contamination, risk of chemical burns, or risk of
scalding when working on the device
When working on the device it must be assumed that the device is
contaminated. Corrosive and/or hot liquids may also be present in the
device.
 Wear personal protective equipment.
 Observe the safety precautions for the disinfectant and the
degreasing agent.
 Actuators must be operated with appropriate precautions against
splashes and fluid leakage.

Personal protective The personal protective equipment should comprise at least the
equipment following items and be used appropriately for the situation:
– Single-use gloves
– Face mask
– Goggles
– Suitable clothing
– Suitable shoes
Local regulations must be observed. If you have any questions, please
contact your local service support organization.

ESD precautions When repairing the device and replacing spare parts, observe the
relevant ESD precautions.

Monitor support arm If the device needs to be placed in a horizontal position for servicing, the
monitor support arm must be locked in place with the transport
protection mechanism to prevent it from swiveling.

Pneumatic tubings For pneumatic connections, use only tube clamps with smooth
surfaces.

Hydraulics that cannot be When opening hydraulics systems in which the disinfection program
disinfected cannot disinfect, disinfect all affected components with an alcohol-
based surface disinfectant (e.g., Freka-NOL) before installing them.

After stopping a
disinfection program
Warning
Risk of poisoning as a result of disinfectants in the dialysis water
supply
Disinfectant can enter the dialysis water supply from the device.
 The device must be disconnected from the dialysis water supply no
later than 72 hours after stopping a disinfection program, or when
putting it into preservation mode.
 When the system is recommissioned, check that the pressure of the
dialysis water supply meets the prescribed minimum pressure.

20 Fresenius Medical Care 6008 SM-EN 11A-2022

 Chapter 2: Important information

Spare parts Use only spare parts approved by the manufacturer. For identifying and
ordering spare parts, test equipment and tools, always use the
electronic spare parts catalog.

After working on the Check that the current Instructions for Use are readily available at the
device point of operation of the device. Ensure the operator is given the
necessary additional instructions on any changes made.
There are certain final tasks to be performed after work has been
carried out on the device. Depending on the type of work performed,
one of more final tasks must be performed.

Note
Time-reduced T1 test without the DIASAFE test step
The DIASAFE test step is not carried out during every T1 test to reduce
the duration of the T1 test.
Only after the following events occur is the next T1 test carried out with
the DIASAFE test step:
– DIASAFE test step failed
– Start of a new day (first T1 test after 0:00)
– From the fourth treatment carried out since the last passed
DIASAFE test step
– Filter change program performed
– Degreasing / cold disinfection cleaning program performed
– SERVICE menu was opened
To carry out a T1 test with the DIASAFE test step, perform the following
steps:
1. Switch to the SERVICE menu.
2. Switch the device off and back on again.
3. Start the T1 test.

If no final tasks are specified in the description of a component (see

chapter 10 on page 255), the following table applies.

Type of work Final tasks Purpose

Device opened.  Measure the protective earth To reestablish the electrical safety
resistance.
 Measure the device leakage
current.

Fluid-carrying  Run a disinfection program. To eliminate any contamination and

component or make sure the hydraulics are
connection opened. working properly

You only need to wait for the disinfection program to complete successfully
if you are also using it to test the proper function of the hydraulics.

Component replaced.  T1 test completed successfully. To make sure the device is working
properly

Fresenius Medical Care 6008 SM-EN 11A-2022 21

Chapter 2: Important information

2.6 Warnings

2.6.1 Warnings about electrical safety

Warning
Risk of injury as a result of an electric shock
For treatments using a central venous catheter, if the tip is positioned in
the patient's right atrium, the following precautions must be observed:
 Make sure the device (6008) is connected to the equipotential
bonding connection of the installation.
 Move all other non-medical electrical equipment and medical
electrical equipment with touch currents or patient leakage currents
in excess of the limits for type CF applied parts out of reach of the
patient (more than 1.5 meters away in any direction).

The touch current or patient leakage current of non-medical or medical

electrical equipment can be conducted to ground via the patient's
central venous catheter and via the type B or BF applied part of the
device (6008).

Intraatrial central venous

catheter

6008
(medical electrical
equipment)
Other electrical
equipment
(medical or non-
medical electrical
equipment)
Patient is
electrically
connected to
ground via blood
and dialysate
(directly, in the case
of a type B applied
part, or capacitively,
in the case of a type
BF applied part).

Patient leakage current limits for type CF applied parts:

– 10 µA AC/DC (normal condition, i.e., no fault condition)
– 50 µA AC/DC (single fault condition)
If you have any questions, please contact your local service support
organization.

22 Fresenius Medical Care 6008 SM-EN 11A-2022

 Chapter 2: Important information

2.7 Addresses

Manufacturer Fresenius Medical Care AG & Co. KGaA

61352 Bad Homburg
GERMANY
Phone: +49 6172 609-0
www.freseniusmedicalcare.com

Service support, Fresenius Medical Care

international Deutschland GmbH
Technical Operations
Technical Coordination Office (TCO)
Hafenstrasse 9
97424 Schweinfurt
GERMANY

Service support, local

Fresenius Medical Care 6008 SM-EN 11A-2022 23

Chapter 2: Important information

24 Fresenius Medical Care 6008 SM-EN 11A-2022

 Chapter 3: Installation

3 Installation
Instructions for installation Instructions for installation are given in the latest Instructions for Use,
and must be followed.

3.1 Initial start-up

3.1.1 Important information on initial start-up

Considerations for Read the information under "Considerations for working on the device"
working on the device (see chapter 2.5 on page 19).

For initial start-up only The following information is only intended for the initial start-up. This
information does not apply to recommissioning devices that have been
taken out of service even temporarily.
If the device is first put into service more than 24 months after delivery,
the Technical Safety Checks (TSCs) and the maintenance procedures
(MAs) must be performed in addition to the start-up.

Environmental conditions Variations in temperature during transport may cause water

condensation on electrical parts. In the event of major variations in
temperature, allow sufficient time for the system to adjust to the ambient
temperature before start-up.

Technical safety checks The first TSCs are required before the end of the 24th month following
(TSCs) initial start-up after delivery from the factory. All further TSCs are
required before the end of the 24th month following the last TSC
performed.
The completion of the TSCs must be recorded in the Medical Device
Register.

Maintenance procedures The maintenance procedures (MAs) are a recommendation of the

(MAs) manufacturer. The maintenance procedures help ensure trouble-free
operation, and must be carried out for the first time before the end of the
24th month following initial start-up after delivery from the factory. All
further maintenance procedures should be performed before the end of
the 24th month following the last maintenance procedure performed.

Qualification requirements The checks must be performed by the manufacturer's service support
of testers organization or a person authorized by it.
The checks must be performed by personnel qualified to perform them
correctly, based on their education, training, knowledge and
experience. Furthermore, the persons performing the checks must be
permitted to do so independently and without outside interference.

Fresenius Medical Care 6008 SM-EN 11A-2022 25

Chapter 3: Installation

Processing the report The report consists of inspection items and the corresponding
explanatory notes. The inspection items and the corresponding
explanations are related to each other and should be processed in
chronological order.

3.1.2 Initial start-up report

Explanatory notes for The explanatory notes for completing the report are in a separate
completing the report chapter (see chapter 3.1.3 on page 30).

26 Fresenius Medical Care 6008 SM-EN 11A-2022

 Chapter 3: Installation

Initial start-up report 6008

Customer number/customer name: Inventory number:
Tester's name: Operating hours:
Software version: Equipment code:
Service report number: Serial number:
No. Designation Operating Measured /NA
state value/correction
Information:  = successful inspection item. NA = non-applicable inspection item.
1 Checks/procedures with device switched off and power plug unplugged
1.1 Device unpacked. Off – 
1.2 Delivery is complete - all parts are present. Delivery package matches the device. Off – 
1.3 No visible shipping damage or dirt on the device. Off – 
2 Preparation
2.1 Transport caps removed from all connectors and any leaked antifreeze removed. Off – 
2.2 Dialysis water inlet tube connected and secured with a tube clamp. Off – 
2.3 Drain tube connected and secured with a tube clamp. Off – 
2.4 Flush tube (option) connected and secured with a tube clamp. Off –  /
2.5 Tube marking for CDS 1 (option) applied to the CDS tube. CDS tube connected to CDS Off –  /
1 (option) and secured with a tube clamp.
2.6 Tube marking for CDS 2 (option) applied to the CDS tube. CDS tube connected to CDS Off –  /
2 (option) and secured with a tube clamp.
2.7 All tubes bundled with no kinks, tension, twisting or pinching. Off – 
Information: Connect the power plug and switch the device on.
2.8 Mandatory rinse program started. Mandatory – 
Ensure that no disinfectant container is connected. rinse
Information: Perform further steps in Mandatory rinse operating state.
2.9 Concentrate container holder (option) mounted. Mandatory –  /
rinse
2.10 smartbag-tray (option) mounted. Mandatory –  /
rinse
2.11 Transport protection for the monitor support arm removed and stored. Mandatory – 
rinse
2.12 IV pole inserted into the monitor support arm and secured with a threaded pin (wrench Mandatory – 
torque: 90 Ncm). rinse
2.13 Top tray (option) mounted. Mandatory –  /
rinse
2.14 Dialyzer holder attached (torque: 70 Ncm). Mandatory – 
rinse
2.15 Strain relief for the network cable (option) fitted. Mandatory –  /
rinse
2.16 Hand crank for manual reinfusion attached on device rear. Mandatory – 
rinse
2.17 Equipotential bonding line connected. Mandatory – 
rinse
2.18 Blood pressure cuff with pressure tubing connected to the BPM (option). Mandatory –  /
rinse
2.19 Blood pressure measurement performed with the BPM (option). Mandatory –  /
Target value: The measured values are plausible. rinse
Information: Prepare and fill in documents.
2.20 Mandatory rinse program completed successfully. Mandatory – 
rinse
2.21 Color coding of the dialyzer couplings and of the shunt interlock adapted to customer Standby – 
specifications (counter-current principle).
 State upon delivery:
Dialysate inlet port (right): Color on dialyzer coupling and shunt interlock = red
Dialysate outlet port (left): Color on dialyzer coupling and shunt interlock = blue
 Alternative state:
Dialysate inlet port (right): Color on dialyzer coupling and shunt interlock = blue
Dialysate outlet port (left): Color on dialyzer coupling and shunt interlock = red
2.22 Filter change program selected. Filter change – 
Both DIASAFE® plus filters connected. Service
Mandatory disinfection deleted in SERVICE menu.
Information: Switch the device off and back on again. Start the Rinse program. Perform further steps in Rinse operating state.
2.23 Procedure recorded on the machine card and in the Medical Device Register. Rinse –  /
2.24 Rinse program completed successfully. Rinse – 
3 Setup
3.1 Date and time set. Standby – 

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Service report number: Serial number:

No. Designation Operating Measured /NA
state value/correction
3.2 Parameters for the Water inlet tube for Flush (option) set. SETUP  /
Length (default value 3 m): / m
Internal diameter (default value 6 mm): / mm
3.3 SETUP (Service setup) and USER SETUP of device checked. SETUP – 
4 Maximum water inflow
4.1 Maximum water inflow when the reverse osmosis unit is running under its normal load CALIBRATE / ml/min 
checked.
Target value: 1300 ml/min to 1550 ml/min (the target value may, under a specific
condition, be 1300 ml/min to 1800 ml/min as described in the explanatory notes).
5 Degassing
Information: Start calibration of degassing.
5.1 Disinfectant connected and secured with strap. CALIBRATE – 
5.2 Calibration of degassing completed successfully. CALIBRATE – 
6 Dialysate pressure
6.1 Zero point of pressure sensors S03 and S07 checked and compared. CALIBRATE 
Target value S03: –30 mbar to +30 mbar / mbar
Target value S07: –30 mbar to +30 mbar / mbar
Target value |(S03 – S07)|: ≤ 20 mbar / mbar
7 Temperature/conductivity
Information: Device set up for verifying temperature and conductivity.
– Open the shunt interlock – bypass
– Dialysate flow: 800 ml/min
– Dialysate temperature: specified value 37.0 °C
– Conductivity: 12.8 mS/cm to 14.0 mS/cm
7.1 Temperature sensors PT7, PT8, and PT9 compared. CALIBRATE 
Target value |(PT7 – PT8)|: ≤ 0.1 °C / °C
Target value |(PT7 – PT9)|: ≤ 0.1 °C / °C
Target value |(specified value – PT7)|: ≤ 0.2 °C / °C
7.2 Conductivity sensors CD7 and CD9 compared. CALIBRATE 
Device display: 12.8 mS/cm to 14.0 mS/cm / mS/cm
Target value |(CD7 – CD9)|: ≤ 0.05 mS/cm / mS/cm
Target value |(expected value – CD7)|: ≤ 0.7 mS/cm / mS/cm
Information: Device set up for verifying temperature and conductivity.
– Open the shunt interlock – bypass
– Dialysate flow: 800 ml/min
– Dialysate temperature: specified value 39.0 °C
– Conductivity: 14.5 mS/cm to 15.7 mS/cm
7.3 Temperature sensors PT7, PT8, and PT9 compared. CALIBRATE 
Target value |(PT7 – PT8)|: ≤ 0.1 °C / °C
Target value |(PT7 – PT9)|: ≤ 0.1 °C / °C
Target value |(specified value – PT7)|: ≤ 0.2 °C / °C
Information: Close the shunt interlock – no bypass
7.4 Mean value of temperature sensors checked. Mean value = (PT7 + PT9) / 2 CALIBRATE / °C 
Target value (mean value – specified value): +0.2 °C to –0.5 °C
7.5 Conductivity sensors CD7 and CD9 compared. CALIBRATE 
Device display: 14.5 mS/cm to 15.7 mS/cm / mS/cm
Target value |(CD7 – CD9)|: ≤ 0.05 mS/cm / mS/cm
Target value |(expected value – CD7)|: ≤ 0.7 mS/cm / mS/cm
8 Blood leak detector, error memory, and data backup
8.1 Blood leak detector checked. CALIBRATE 
Target value for blood leak voltage: 4.8 Volt to 5.2 Volt / Volt
Target value for dimness voltage: 4.7 Volt to 5.3 Volt / Volt
8.2 Error memory erased. CALIBRATE – 
8.3 Calibration data and setup settings saved. CALIBRATE – 
9 Cassette sensors
9.1 Cassette sensors calibrated. CALIBRATE – 
10 Electrical safety check according to (DIN) EN 62353:2015, IEC 62353:2014, and functional test
Information: Switch off the device.
10.1 Protective earth resistance measured and checked. Off / Ω 
Target value: ≤ 0.3 Ω with power supply cord
10.2 Arterial and venous occlusion clamps checked. Off – 
Information: Switch the device on. Start the T1 test. Perform further steps in T1 test operating state.

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Service report number: Serial number:

No. Designation Operating Measured /NA
state value/correction
10.3 Zero point of arterial, venous, and pre-filter pressure displays checked. T1 test, EBM – 
Target value for arterial pressure: 0 mmHg ±5 mmHg Flow / mmHg
Diagram
Target value for venous pressure: 0 mmHg ±5 mmHg / mmHg
Target value for pre-filter pressure: 0 mmHg ±5 mmHg / mmHg
10.4 Slope of the arterial, venous, and pre-filter pressure displays checked with a built-up T1 test, EBM – 
pressure of approx. 280 mmHg. Flow
Target value for arterial pressure: built-up pressure ±10 mmHg Diagram / mmHg
Target value for venous pressure: built-up pressure ±10 mmHg / mmHg
Target value for pre-filter pressure: built-up pressure ±15 mmHg / mmHg
Information: Create service report.
10.5 T1 test completed successfully. T1 test – 
(Perform further checks only after completion of the T1 test.)
10.6 Applied part type: type B Preparation 
Device leakage currents of applied part type B measured, measurement value scaled
to nominal line voltage and checked against "Additional condition".
Target value: IN ≤ 500 μA
 Differential current measurement according to figure 8
 Direct measurement according to figure 7
Nominal voltage of the power supply (U0) V
AC polarity L – N:
Maximum device leakage current (IBmax) / μA
Actual line voltage measured (UBmax) / V
Device leakage current scaled to nominal line voltage (IN = (U0 × IBmax): UBmax) / μA
AC polarity N – L:
Maximum device leakage current (IBmax) / μA
Actual line voltage measured (UBmax) / V
Device leakage current scaled to nominal line voltage (IN = (U0 × IBmax): UBmax) / μA
11 Final tasks
11.1 Disinfection program with Puristeril 340, Puristeril plus, Diasteril, or Citrosteril started. Cleaning – 
Disinfectant drawn in.
Information: Perform further steps in Cleaning operating state.
11.2 Shunt interlock opened during disinfection program and alarm function checked Cleaning – 
(audible alarm and operating status indicator).
11.3 Instructions for Use match the device. Cleaning – 
11.4 All waste properly disposed of. Cleaning – 
11.5 All documents created. Cleaning – 
11.6 Only with USER SETUP  Cleaning  Check for residual disinfectant = Manual and Standby –  /
disinfection program with Puristeril 340, Puristeril plus or Diasteril:
Disinfection program completed successfully. Absence of residual disinfectant verified
by means of test strips after disinfection program.
Confirmation of the inspection
Service report number: Serial number:
Test equipment used (type and serial number):

Inspection comments:

Date of inspection: Tester's signature: Tester's name:

#FMESIG_1##

Assessment of the inspection

The device is released for its intended use.  Yes  No Date of next inspection:
The inspection label has been attached to the device.
Comments on the assessment:

Date of assessment: Signature of representative of the responsible Name of representative of the responsible
organization: organization:

#FMESIG_2##

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3.1.3 Explanatory notes for completing the initial start-up report

Report header

Customer number/customer  Record the customer number/customer name of the end customer.
name

Tester's name  Record the first name and last name of the technician carrying out
the work.

Software version  Record the software version.

Service report number  Record the number of the service call.

Inventory number  Record the inventory number assigned to the device, if any.

Operating hours  Record the operating hours.

Equipment code  Record the equipment code shown on the device (e.g., EC, E-Code).

Serial number  Record the serial number of the device.

Significance of the
columns

No. Number of the inspection item in the report.

Designation Description of the inspection item in the report.

Operating state Required state of the device when carrying out the inspection item.

Measured value/correction  Record the first measured value.

 If the first measured value does not correspond to the target value,
also record the new measured value after the problem has been
corrected.

/NA  Mark the checkbox under  after successfully completing the

inspection item.
 Mark the checkbox under NA if the inspection item does not apply
(e.g., if an option is not present or maintenance procedures are not
required, etc.).

Re: 1 Checks/procedures with device switched off and power plug

unplugged

Re: 1.1 Device unpacked.

Operating state: Off
 Unpack the device.
 Save the transport packaging for possible future return shipments.

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Re: 1.2 Delivery is complete - all parts are present. Delivery package
matches the device.
Operating state: Off
 Verify that all parts of the device are included in the delivery.
 Check that the delivery package matches the device.
 Inform the responsible local service support organization without
delay if parts are missing.

Re: 1.3 No visible shipping damage or dirt on the device.

Operating state: Off
 Check that all the components of the device have been delivered,
and check for any apparent damage and contamination affecting
safety.
 Replace damaged labels and inscriptions.
 Check that electrical and mechanical properties are not affected by
damage or dirt.
 Check that the monitor can be swiveled horizontally and maintains
the required position.
 Check the brake. If the brake is not locked, the trolley can be moved
as required.
 Check power supply cord for signs of damage.

Re: 2 Preparation

Re: 2.1 Transport caps removed from all connectors and any leaked
antifreeze removed.
Operating state: Off

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Chapter 3: Installation

Fig.: Transport caps

 Remove the transport caps from the following connectors and collect
any leaked antifreeze:
– Connector for CDS 1 (option) (1)
– Flush drain (option) (2)
– Dialysis water connector (3)
– Overflow of water inlet chamber (4)
– Drain (5)
– Connector for CDS 2 (option) (6)

Re: 2.2 Dialysis water inlet tube connected and secured with a tube clamp.
Operating state: Off
 Ensure hygienic conditions.
 Use tubing with undamaged packaging.
 Do not open the packaging until shortly before installation.
 Do not touch the ends of the tubing and the adapters.
 Connect the dialysis water inlet tube.
 Secure the dialysis water inlet tube with a tube clamp.

Re: 2.3 Drain tube connected and secured with a tube clamp.
Operating state: Off
 Connect the drain tube.
 Secure the drain tube with a tube clamp.

Re: 2.4 Flush tube (option) connected and secured with a tube clamp.
Operating state: Off
 Connect the Flush tube (option).
 Secure the Flush tube (option) with a tube clamp.

Re: 2.5 Tube marking for CDS 1 (option) applied to the CDS tube. CDS tube
connected to CDS 1 (option) and secured with a tube clamp.
Operating state: Off
 Tube marking for CDS 1 (option) applied to the CDS tube.
 Connect the CDS tube to CDS 1 (option).

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 Secure the CDS tube on CDS 1 (option) with a tube clamp.

Re: 2.6 Tube marking for CDS 2 (option) applied to the CDS tube. CDS tube
connected to CDS 2 (option) and secured with a tube clamp.
Operating state: Off
 Tube marking for CDS 2 (option) applied to the CDS tube.
 Connect the CDS tube to CDS 2 (option).
 Secure the CDS tube on CDS 2 (option) with a tube clamp.

Re: 2.7 Tubes bundled with no kinks, tension, twisting or pinching.

Operating state: Off

Note
Risk of tubing constriction
Risk of damage to the connectors
 When bundling the tubes, care must be taken to avoid kinks, tension,
twisting or pinching.

Re: 2.8 Mandatory rinse program started.

Ensure that no disinfectant container is connected.
Operating state: Mandatory rinse
 Connect the power plug.
 Switch the device on.
 Insert the ServiceCard.
 If necessary, remove the disinfectant container.
Message: Perform a mandatory rinse! – Start – Cleaning menu.
 Select the Start field.
Depending on the setting, one of the following messages is displayed
after rinsing:
– Message: The check for residual disinfectant was successfully
completed. – OK.
– Message: Manually check for the absence of residual disinfectant!
– Ignore – Start.
 Select the OK or Ignore field.

Re: 2.9 Concentrate container holder (option) mounted.

Operating state: Mandatory rinse

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Chapter 3: Installation

 Slot the concentrate container holder (option) (1) into the guide (2)
until the holding springs engage on both sides.

Re: 2.10 smartbag-tray (option) mounted.

Operating state: Mandatory rinse

 Position the smartbag tray (option) (1) as shown.

 Attach the smartbag tray (option) (1) to the concentrate container

holder (option) (2).

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Re: 2.11 Transport protection for the monitor support arm removed and
stored.
Operating state: Mandatory rinse

 Loosen and remove the screw (1).

 Keep the screw (1) for future transport.

Re: 2.12 IV pole inserted into the monitor support arm and secured with a
threaded pin (wrench torque: 90 Ncm).
Operating state: Mandatory rinse
 Insert the IV pole into the monitor support arm.
 Secure the IV pole with a threaded pin (wrench torque: 90 Ncm).
 Fit the protective cover for the monitor support arm.
 Screw the IV pole hanger onto the IV pole.

Re: 2.13 Top tray (option) mounted.

Operating state: Mandatory rinse

 Attach the holder (1) to the IV pole.

 Insert the top tray (2) in the holder (1).

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Re: 2.14 Dialyzer holder attached (torque: 70 Ncm).

Operating state: Mandatory rinse

 Fit the dialyzer holder.

 If no new threadlocker has been applied to the threaded pin (1):

Apply 1 drop of Loctite 243 threadlocker to the thread of the
threaded pin.
 Screw the dialyzer holder in place with the threaded pin (1).
Specified wrench torque for threaded pin (1): 70 Ncm

Re: 2.15 Strain relief for the network cable (option) fitted.
Operating state: Mandatory rinse

 Fit strain relief (1) on the push handle.

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Re: 2.16 Hand crank for manual reinfusion attached on device rear.
Operating state: Mandatory rinse

 Attach hand crank (1) for manual reinfusion on device rear.

Re: 2.17 Equipotential bonding line connected.

Operating state: Mandatory rinse

 Connect the equipotential bonding line to the equipotential bonding

connection (1).

Re: 2.18 Blood pressure cuff with pressure tubing connected to the BPM
(option).
Operating state: Mandatory rinse
 Connect the pressure tubing to the BPM (option).
 Connect the blood pressure cuff to the pressure tubing.

Re: 2.19 Blood pressure measurement performed with the BPM (option).
Operating state: Mandatory rinse
 In the OPTIONS menu, select the BPM field.
 Additionally with BPM version 1:
Select the Preselected pressure field and set the value 160 mmHg.
 Wrap the blood pressure cuff around your arm.
 Select the Bld. press. field.
The blood pressure is measured.
 After the measurement, check whether the values are plausible.
Target value: The measured values are plausible.

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Re: 2.20 Mandatory rinse program completed successfully.

Operating state: Mandatory rinse
 Wait until the cleaning program has been completed successfully.

Re: 2.21 Color coding of the dialyzer couplings and of the shunt interlock
adapted to customer specifications (counter-current principle).
Operating state: Standby
 Adapt coding of the dialyzer couplings and of the shunt interlock as
required by the customer.
 Ensure counter-current principle by correct color coding.
 Record the change in the Medical Device Register.
State upon delivery:
Dialysate inlet port (right): Color on dialyzer coupling and shunt interlock
= red
Dialysate outlet port (left): Color on dialyzer coupling and shunt interlock
= blue
Alternative state:
Dialysate inlet port (right): Color on dialyzer coupling and shunt interlock
= blue
Dialysate outlet port (left): Color on dialyzer coupling and shunt interlock
= red

Re: 2.22 Filter change program selected. Both DIASAFE® plus filters
connected. Mandatory disinfection deleted in SERVICE menu.
Operating state: Filter change/Service
 In the CLEANING menu, select the Filter change field.
 Select the Both filters field.
 Select the Start field.
Message: Emptying of filters completed. Change the following filters:
$$$ Press "Confirm" after changing the filter! – Confirm.
 Ensure hygienic conditions.
 Use both DIASAFE® plus filters with undamaged packaging.
 Do not open the packaging until shortly before installation.
 Do not remove the protective covering until shortly before
installation.
 Do not touch the connectors.

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 Remove the preservation adapter (1) and shunt caps.

 Connect both DIASAFE® plus filters.
Only use both DIASAFE® plus filters included with the accessories if the
“Use by” date is at least 6 months after the date of installation at initial
start-up.
 Select the Confirm field.
Message: Perform a disinfection! – Cleaning menu.
 In the SYSTEM menu, select the SERVICE field.
 In the MODULE  Novram menu, select the Delete mandatory
disinfection field.
Message: WARNING: The mandatory disinfection is going to be
deleted! – Confirm – Stop.
 Select the Confirm field.
 Switch off the device.
 Switch the device on.
 In the CLEANING menu, select the Rinse field.
 Select the Start field.

Re: 2.23 Procedure recorded on the machine card and in the Medical
Device Register.
Operating state: Rinse
 Record the procedure on the machine card.
 Record the procedure in the Medical Device Register.

Re: 2.24 Rinse program completed successfully.

Operating state: Rinse
 Wait until the cleaning program has been completed successfully.

Re: 3 Setup

Re: 3.1 Date and time set.

Operating state: Standby

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 Select the SYSTEM menu.

 Enter setting in the Date field (can only be changed with the
ServiceCard).
 Enter setting in the Time field (can only be changed with device on
standby).
 Select the SERVICE field.

Re: 3.2 Parameters for the Water inlet tube for Flush (option) set.
Operating state: SETUP
 Select the SETUP  Settings Hydraulics menu.
 Set the parameters Length and Internal diameter.
Default value of Length = 3 m
Default value Internal diameter = 6 mm

Re: 3.3 SETUP (Service setup) and USER SETUP of device checked.
Operating state: SETUP
 Make the appropriate settings for the hospital as necessary.
 Set the Installation altitude in the SETUP  Settings Hydraulics
 Heater rod  Installation altitude menu.
 Set cleaning programs and disinfectants used on-site in the SETUP
 Define cleaning parameters menu (page 1).

Re: 4 Maximum water inflow

Re: 4.1 Maximum water inflow when the reverse osmosis unit is running
under its normal load checked.
Operating state: CALIBRATE
Requirements:
The dialysis water inlet pressure and the dialysis water inlet rate are
subject to changes if more devices than one are operated on one
reverse osmosis unit. The maximum water inflow (Max. water inflow)
should therefore be checked and set under ordinary treatment
conditions. This means, for example, that if an average of 30 devices
are used for treatment in normal operation, the reverse osmosis unit
should also be loaded with 30 devices.
– Observe environmental conditions.
– Make sure the reverse osmosis unit is running under its normal load.

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Tip
If water deficiency alarms occur sporadically, the maximum water inflow
should be checked with the following loads on the reverse osmosis unit.
In each case, the maximum water inflow should be within the limits
specified.
Low load: Load the reverse osmosis unit with approx. every sixth
device.
Medium load: Load the reverse osmosis unit with approx. every
second device.
Maximum load: Load the reverse osmosis unit with all devices.

 Select the SERVICE menu.

 Select the CALIBRATE menu.
The hydraulics are working.
 Select the field in the status bar to display the animated flow
diagram.
By repeatedly selecting the field, it is possible to switch between
the EBM Flow Diagram and the Flow diagram.

Note
Incorrect maximum water inflow value due to water deficiency
alarm
In the event of a water deficiency alarm, the flow diagram shows the
previously measured value of the Max. water inflow in red.
 Correct the water deficiency alarm.

Note
A dialysate flow of 1000 ml/min cannot be reliably achieved due to
insufficient water inflow
If the maximum water inflow is less than 1300 ml/min, a dialysate flow
of 1000 ml/min cannot be reliably achieved.
 Set the maximum water inflow to ≥ 1300 ml/min.

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Note
Water deficiency alarm associated with widely fluctuating dialysis
water inlet pressure
A widely fluctuating dialysis water inlet pressure can lead to a water
deficiency alarm.
 The maximum water inflow should preferably be accomplished with
a dialysis water inlet pressure of 2.5 to 4.0 bar.
 The maximum water inflow can, in exceptional cases, be set to a
value up to 1800 ml/min with a dialysis water inlet pressure of 2.5 to
4.0 bar.
Exceeding the target value of 1300 ml/min to 1550 ml/min may cause
other devices to experience water deficiency problems.

 Wait at least one minute until the value has stabilized.

 Check the Max. water inflow [ml/min] value in the animated flow
diagram.
Target value: 1300 ml/min to 1550 ml/min

Re: 5 Degassing

Re: 5.1 Disinfectant connected and secured with strap.

Operating state: CALIBRATE
Requirement: Flow on.
 Select the Degassing (A02/P01) field.
 Start calibration of degassing (see chapter 9.4.3 on page 229).
 Connect disinfectant according to customer specifications.
 Secure disinfectant with strap.

Re: 5.2 Calibration of degassing completed successfully.

Operating state: CALIBRATE
 Wait until the calibration has been completed successfully.

Re: 6 Dialysate pressure

Re: 6.1 Zero point of pressure sensors S03 and S07 checked and
compared.
Operating state: CALIBRATE
Requirements:
– Plausibility check must have been successfully completed (e.g.,
Degassing selected after device On/Off).
– The device must be closed.

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 Switch the flow on until the dialysate lines are cleared of air.
 Switch the flow off.
 Remove both dialysate lines from the shunt interlock and bring them
to the same level as the shunt interlock (1).
 Close the shunt interlock.
 Check zero point S03/S07.
Target value S03: –30 mbar to +30 mbar
Target value S07: –30 mbar to +30 mbar
 Compare pressure sensors S03 and S07.
Target value |(S03 – S07)|: ≤ 20 mbar
 Insert both dialysate lines back into the shunt interlock.
Example:
S03: –10 mbar
S07: –5 mbar
Difference S03/S07: Difference |(–10 mbar – (–5 mbar)| = 5 mbar

Re: 7 Temperature/conductivity

Re: 7.1 Temperature sensors PT7, PT8, and PT9 compared.

Operating state: CALIBRATE
Requirement: The device must be closed.
 Close the device.
 Open the shunt interlock.
The device is in bypass mode.
 Connect the concentrates as necessary.
 Select the concentrates as necessary.
 Make sure that the concentrates connected correspond to the set
concentrate type.
 Select the CALIBRATE menu.

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 Select the Desired temperature field and set 37.0 °C.

 Select the Desired flow field and set 800 ml/min.
 Switch on Flow as necessary.
 Select the Prescr. Na and Prescr. Bic fields and set the conductivity
to between 12.8 mS/cm and 14.0 mS/cm.
 Wait until the values have stabilized.
 Compare sensors PT7, PT8 and PT9.
Target value |(PT7 – PT8)|: ≤ 0.1 °C
Target value |(PT7 – PT9)|: ≤ 0.1 °C
Target value |(specified value – PT7)|: ≤ 0.2 °C

Re: 7.2 Conductivity sensors CD7 and CD9 compared.

Operating state: CALIBRATE
 Select the Prescr. Na field.
 Read off the expected value in the CD field.
 Select the OK field.
 Wait until the values have stabilized.
 Check conductivity display of device.
Target value: 12.8 mS/cm to 14.0 mS/cm
 Compare sensors CD7 and CD9.
Target value |(CD7 – CD9)|: ≤ 0.05 mS/cm
Target value |(expected value – CD7)|: ≤ 0.7 mS/cm

Re: 7.3 Temperature sensors PT7, PT8, and PT9 compared.

Operating state: CALIBRATE
Requirement: The device must be closed.
 Select the Desired temperature field and set 39.0 °C.
 Select the Prescr. Na and Prescr. Bic fields and set the conductivity
to between 14.5 mS/cm and 15.7 mS/cm.
 Wait until the values have stabilized.
 Compare sensors PT7, PT8 and PT9.
Target value |(PT7 – PT8)|: ≤ 0.1 °C
Target value |(PT7 – PT9)|: ≤ 0.1 °C
Target value |(specified value – PT7)|: ≤ 0.2 °C

Re: 7.4 Mean value of temperature sensors checked.

Operating state: CALIBRATE
 Close the shunt interlock.
 Wait until the values have stabilized.
 Check the mean value of the temperature sensors PT7 and PT9.
Mean value = (PT7 + PT9) / 2
Target value (mean value – specified value): +0.2 °C to –0.5 °C

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Re: 7.5 Conductivity sensors CD7 and CD9 compared.

Operating state: CALIBRATE
 Select the Prescr. Na field.
 Read off the expected value in the CD field.
 Select the OK field.
 Wait until the values have stabilized.
 Check conductivity display of device.
Target value: 14.5 mS/cm to 15.7 mS/cm
 Compare sensors CD7 and CD9.
Target value |(CD7 – CD9)|: ≤ 0.05 mS/cm
Target value |(expected value – CD7)|: ≤ 0.7 mS/cm

Re: 8 Blood leak detector, error memory, and data backup

Re: 8.1 Blood leak detector checked.

Operating state: CALIBRATE
Requirements:
– The device must be closed (avoid exposure to external light).
– Flow on, flow 500 ml/min.
– Dialysate temperature: 34 °C to 39 °C.
– Stable conductivity.
 Check blood leak voltage.
Target value for blood leak voltage: 4.8 Volt to 5.2 Volt
 Check dimness voltage.
Target value for dimness voltage: 4.7 Volt to 5.3 Volt

Re: 8.2 Error memory erased.

Operating state: CALIBRATE
 Create connection between PC Service Software and the device
with read and write authorizations (see chapter 5.5.2 on page 135).
 Erase the error memory using the PC Service Software.

Re: 8.3 Calibration data and setup settings saved.

Operating state: CALIBRATE
 Back up the calibration data and setup settings using the PC Service
Software.

Re: 9 Cassette sensors

Re: 9.1 Cassette sensors calibrated.

Operating state: Service, CALIBRATE
Requirement: Cassette system not inserted.

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Chapter 3: Installation

 If the device is not switched on and negative pressure has not been
created, switch the device on and wait until the system compressor
is no longer active (see chapter 9.3 on page 224).
 Check that the pneumatics negative pressure (1) displayed in the
EBM Flow Diagram is stable.

 Ensure that the cassette contact mat is still correctly seated at the
marked positions after the negative pressure has been created.
Example pictures of improperly installed cassette contact mats (see
chapter 10.15.3 on page 484).
 Close the door.
 Check the Installation altitude field in the SETUP  Settings
Hydraulics menu.
 Select the Start calibration field in the CALIBRATE  Cassette
sensors menu.
Cassette sensors are calibrated.
 Follow the on-screen instructions.
Message: Calibration of the cassette sensors was successfully
completed. – Confirm
 Select the Confirm field.

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Re: 10 Electrical safety check according to (DIN) EN 62353:2015,

IEC 62353:2014, and functional test

Re: 10.1 Protective earth resistance measured and checked.

Operating state: Off
 Remove any external test equipment.
 Connect the dialyzer couplings to the shunt interlock.
 Close the shunt interlock.
 Switch off the device.
 Unplug the power plug of the device.
 Plug the test equipment for the electrical safety check into the AC
power supply.
 Plug the power plug of the device into the test equipment for the
electrical safety check.
 Make sure the power switch on the rear of the device is switched on.
 Set the test equipment for the electrical safety check to the mode for
measuring the protective earth resistance.
 Check the protective earth resistance at the following measurement
points.
Target value: ≤ 0.3 Ω with power supply cord
A test current between 200 mA and 1 A is recommended for measuring
the protective earth resistance so that interruptions or unstable
connections (loose contacts) can be detected clearly. Using a higher
test current may have a welding effect and, as a result, make unstable
connections appear to be good connections.

Fig.: Measurement point – power supply unit (PSU housing) (1)

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Chapter 3: Installation

Fig.: Measurement point – shunt interlock flap (2)

Fig.: Measurement points – lower part of rear

– Heater rod chamber (3)
– Equipotential bonding connection (4)

Fig.: Measurement points – EBM pumps (5) (e.g., substituate pump)

– Blood pump
– Substituate pump

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 Chapter 3: Installation

Fig.: Measurement points – cassette positioning pin and door lock

– Cassette positioning pin (right) (6)
– Door lock (7)

 Measure the protective earth resistances at the following points on

the EBM using a test current of 200 mA:
– Cassette positioning pin (right) (6)
– Door lock (7)
This is necessary to avoid scorch marks and damage.

Fig.: Door (non-anodized hole) (8)

 Remove the screw protection cap.

 Measure the protective earth resistance on the door (non-anodized
hole) (8) using a test current of 200 mA.
This is necessary to avoid scorch marks and damage.
 Insert the new screw protection cap.

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Chapter 3: Installation

Fig.: Measurement points – BTM (option)

– Arterial measuring head (9)
– Venous measuring head (10)

10

 Measure the protective earth resistances at the following points on

the BTM (option) using a test current of 200 mA:
– Arterial measuring head (9)
– Venous measuring head (10)
This is necessary to avoid scorch marks and damage.

Fig.: Measurement point – BVM (option) (11)

11

 Measure the protective earth resistance on the BVM (11) (option)

using a test current of 200 mA.
This is necessary to avoid scorch marks and damage.

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 Chapter 3: Installation

Re: 10.2 Arterial and venous occlusion clamps checked.

Operating state: Off

 Check the arterial and venous occlusion clamps for damage at the
following points:
– Catch (1)
– Valve tappet (2)
– Clamping and tappet surfaces (3)
 Push back the catch.
A distinct counterpressure must be felt.
 Release the catch.
The tappet returns to its starting position.

Re: 10.3 Zero point of arterial, venous, and pre-filter pressure displays
checked.
Operating state: T1 test or Preparation

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Chapter 3: Installation

 Set the test equipment for the electrical safety check to the mode for
measuring equipment leakage currents.
 Switch the device on.
 Start the T1 test (see chapter 10.3.1 on page 268).

1
2
3

 Leave dialyzer couplings in the shunt interlock.

 Insert a dry cassette system as shown.
 Remove all caps from the cassette system.
 Tighten the arterial and venous patient connections on the rinse
connector.
 Connect the rinse connector to the rinse port (1) and close the rinse
port (1).
 Close the arterial insertion site (2).
 Close the door.
 In the BLOOD SYSTEM menu, select the Lock door field.
The door is locked and the cassette system is connected.
 Connect the venous dialyzer connector to the reference meter (3)
using the long tube adapter (4).
 Make sure the arterial dialyzer connector (5) is open to atmosphere.
 Check the status display of the cassette coupling sensor in the EBM
Flow Diagram.
Target value: Status indicator lights up green.
 Wait five seconds. This ensures that enough measurements are
available for the averaged values.
 Check the arterial pressure in the EBM Flow Diagram.
Target value: 0 mmHg ±5 mmHg

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 Chapter 3: Installation

 Check the venous pressure in the EBM Flow Diagram.

Target value: 0 mmHg ±5 mmHg
 Check the pre-filter pressure in the EBM Flow Diagram.
Target value: 0 mmHg ±5 mmHg

Re: 10.4 Slope of the arterial, venous, and pre-filter pressure displays
checked with a built-up pressure of approx. 280 mmHg.
Operating state: T1 test or Preparation

 Leave dialyzer couplings in the shunt interlock.

 Connect a syringe filled with air (1) to the venous insertion line.
 Open the arterial insertion site (2).
 Connect the arterial dialyzer connector to the arterial insertion site
(2) using the short tube adapter (3).
 Use the syringe to build up a pressure of approximately 280 mmHg.
 Wait until the value has stabilized.
 Check the arterial pressure in the EBM Flow Diagram.
Target value: built-up pressure ±10 mmHg
 Check the venous pressure in the EBM Flow Diagram.
Target value: built-up pressure ±10 mmHg
 Check the pre-filter pressure in the EBM Flow Diagram.
Target value: built-up pressure ±15 mmHg
Example with ±10 mmHg:
Built-up pressure: 283 mmHg
Target value: 273 mmHg to 293 mmHg

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Chapter 3: Installation

Example with ±15 mmHg:

Built-up pressure: 283 mmHg
Target value: 268 mmHg to 298 mmHg
 Remove the rinse connector from the rinse port.
 Close the rinse port.
 In the BLOOD SYSTEM menu, select the Remove lines field.
 Remove the cassette system.

Re: 10.5 T1 test completed successfully.

Operating state: T1 test
 Wait until the T1 test has been successfully completed.
 Perform further checks only after successful completion of the T1
test.

Re: 10.6 Applied part type: type B

Device leakage currents for Type B applied part measured, scaled
to nominal line voltage, and checked taking the “Additional
condition” into account.
Operating state: Preparation
Requirements:
– Protective earth resistance measured and checked.
– Device is at operating temperature.
– Dialysate temperature: ≥ 36 °C
– Dialysate flow: ≥ 300 ml/min
– Dialysate conductivity: ≥ 13 mS/cm
Additional requirements for direct measurement according to figure 7:
– The device must be isolated from earth during the measurement.
– All external lines must be disconnected from the device.
– Do not touch the device while the measurement is in progress.
 Remove any external test equipment.
 Connect the dialyzer couplings to the shunt interlock.
 Close the shunt interlock.

Fig.: Differential current measurement according to figure 8

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Fig.: Direct measurement according to figure 7

 Set up the device for differential current measurement according to

figure 8 or for direct measurement according to figure 7.
 Record the nominal voltage of the power supply (U0).

AC polarity L – N:
 Measure and record the maximum device leakage current (IBmax).
 Measure and record the actual line voltage (UBmax).
 Scale the measured device leakage current value to the nominal line
voltage and record it (IN).
Formula: IN = (U0 x IBmax): UBmax
 Check the scaled device leakage current (IN), taking the "Additional
condition" (see Additional condition on page 55) into account.
Target value: IN ≤ 500 μA

AC polarity N – L:
 Change AC polarity (from L – N to N – L).
 Measure and record the maximum device leakage current (IBmax).
 Measure and record the actual line voltage (UBmax).
 Scale the measured device leakage current value to the nominal line
voltage and record it (IN).
Formula: IN = (U0 x IBmax): UBmax
 Check the scaled device leakage current (IN), taking the "Additional
condition" (see Additional condition on page 55) into account.
Target value: IN ≤ 500 μA

Additional condition If either of the scaled device leakage current values (IN) is higher than
450 μA, the last scaled device leakage current values (IN–1) must
additionally be considered for the rating.
 Find out the last scaled device leakage currents (IN–1).
 Calculate and check the device leakage currents taking the
"Additional condition" into account (IA).
Formula: IA = IN + (IN – IN–1)
Target value: IA ≤ 500 μA

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Examples – Example of a successful measurement:

Nominal voltage of the power supply (U0) 230 V

Maximum device leakage current (IBmax) 180 μA

Actual line voltage measured (UBmax) 225 V

Scaled device leakage current (IN) 184 μA

IN = (U0 × IBmax): UBmax
IN = (230 V × 180 μA): 225 V

Target value: IN = 184 μA ≤ 500 μA? Value OK

Additional condition: IN = 184 μA < 450 μA? Value OK

Measurement result: Measurement passed

– Example of a successful measurement taking last scaled device

leakage currents into account:

Nominal voltage of the power supply (U0) 230 V

Maximum device leakage current (IBmax) 474 μA

Actual line voltage measured (UBmax) 232 V

Scaled device leakage current (IN) 470 μA

IN = (U0 × IBmax): UBmax
IN = (230 V × 474 μA): 232 V

Target value: IN = 470 μA ≤ 500 μA? Value OK

Additional condition: IN = 470 μA < 450 μA? Value not OK

Take last scaled device leakage currents (IN–1) into account.

Last scaled device leakage current (IN–1) 450 μA

Device leakage current according to "Additional 490 μA

condition" (IA)
IA = IN + (IN – IN–1)
IA = 470 μA + (470 μA – 450 μA) = 490 μA

Target value: IA = 490 μA ≤ 500 μA? Value OK

Measurement result: Measurement passed

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– Example of a failed measurement:

Nominal voltage of the power supply (U0) 230 V

Maximum device leakage current (IBmax) 474 μA

Actual line voltage measured (UBmax) 232 V

Scaled device leakage current (IN) 470 μA

IN = (U0 × IBmax): UBmax
IN = (230 V × 474 μA): 232 V

Target value: IN = 470 μA ≤ 500 μA? Value OK

Additional condition: IN = 470 μA < 450 μA? Value not OK

Take last scaled device leakage currents (IN–1) into account.

Last scaled device leakage current (IN–1) 390 μA

Device leakage current according to "Additional 550 μA

condition" (IA)
IA = IN + (IN – IN–1)
IA = 470 μA + (470 μA – 390 μA) = 550 μA

Target value: IA = 550 μA ≤ 500 μA? Value not OK

Measurement result: Measurement failed

Re: 11 Final tasks

Re: 11.1 Disinfection program with Puristeril 340, Puristeril plus, Diasteril,
or Citrosteril started. Disinfectant drawn in.
Operating state: Cleaning
 Start disinfection program with Puristeril 340, Puristeril plus,
Diasteril, or Citrosteril.
 Ensure that the disinfectant was drawn in.

Re: 11.2 Shunt interlock opened during disinfection program and alarm
function checked (audible alarm and operating status indicator).
Operating state: Cleaning
 Open the shunt interlock.
 Check the audible alarm and the operating status indicator.
 Check the message.
 Close the shunt interlock again.
The disinfection program will be continued.

Re: 11.3 Instructions for Use match the device.

Operating state: Cleaning
 Check that the Instructions for Use match the device.

Re: 11.4 All waste properly disposed of.

Operating state: Cleaning
 Make sure all waste is properly disposed of.

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Re: 11.5 All documents created.

Operating state: Cleaning
 Complete all the required documents.
 If the local service support organization has implemented a service
database, record the following items in the service report:
– Current operating hours
– Correct job code
– Test equipment used
– Values for electrical safety check
– E-code
– S-code
– Action performed
– Parts used

Re: 11.6 Only with USER SETUP  Cleaning  Check for residual
disinfectant = Manual and disinfection program with Puristeril 340,
Puristeril plus or Diasteril:
Disinfection program completed successfully. Absence of
residual disinfectant verified by means of test strips after
disinfection program.
Operating state: Standby
 Wait until the cleaning program has been completed successfully.
 Check absence of residual disinfectant by means of test strips (not
for Citrosteril).

Confirmation of the
inspection

Test equipment used (type  Record the type and serial number of all the test equipment used.
and serial number)

Inspection comments  Record any irregularities encountered during the inspection.

Date of inspection, tester's  Confirm the inspection by adding the date as well as the tester’s
signature and name signature and name.
The tester’s name can be replaced by a stamp required by the country
in question.

Assessment of the
inspection

The device is released for its There must be no risk to patients, staff or third parties during the
intended use intended use of the device.
 Make a definite decision as to whether or not the device can
continue to be used.
 Record this decision by marking Yes or No.
 Depending on your decision, affix the inspection label to the device.
 Inform the responsible organization of any defects of the device
without delay.

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Date of next inspection  Record the next test date, taking the intervals specified by the
manufacturer into account.

Assessment comments  Record any irregularities encountered during the assessment.

Date of assessment,  Confirm the assessment by adding the date as well as the signature
signature and name of and name of the representative of the responsible organization.
representative of the
The name of the representative of the responsible organization can be
responsible organization
replaced by a stamp required by the country in question.

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3.2 Transporting the device

Warning
Risk of chemical burns during transport
Risk of scalding during transport

Warning, corrosive substances

Warning, hot surfaces, hot liquids and hot vapors

During cleaning programs, the hydraulics are rinsed out with a

disinfectant and/or a hot liquid. If the device is transported before the
cleaning programs have completely finished, touching certain parts of
the device can result in chemical burns and/or scalding.
 Only transport devices after cleaning programs such as disinfection
or heat disinfection (incl. cool down rinse) have completely finished.

Warning
Risk of injury through device tilting

Tipping hazard when pushing the device or leaning against

it or if maximum inclination of 5° is exceeded

Lateral force exerted on the device, or an inclination exceeding 5°, can

result in the device tilting or slipping.
 Make sure you follow the instructions for relocation and transport.
 Make sure the device is in a secure upright position.

3.2.1 Relocation

Definition of relocation In professional healthcare facilities, the device can be moved between
rooms in the same building by the operator. It can be moved only over
smooth, even floors, but level differences up to 1 cm can be overcome
if necessary (e.g., elevator thresholds).

Preparing for relocation  Switch off the device.

 Unplug the power plug and secure the power supply cord on the
device.
 Remove the dialysis water inlet tube from the supply.
 Remove the drain tube from the drain.

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 Individually protect the dialysis water inlet tube and drain tube
against contamination and leakage and secure them to the device.
Do not connect the dialysis water inlet tube and the drain tube to
each other.
 Disconnect CDS tubes. Individually protect the tubes against
contamination and leakage and secure them to the device.
 Check that the disinfectant container is firmly secured.
 Remove the concentrate containers.
 Remove any objects suspended from the IV pole and fully retract the
IV pole.
 Close the door.
 Position the monitor above the device in the center.

Carrying out relocation  Release the brake.

 Using the push handle of the device, push it with its front side facing
forward. Watch out for obstacles.
 Observe the following to avoid damage to or tipping over of the
device when overcoming obstacles up to a height of 1 cm:
– Grasp the device by the push handle and pull it until both rear
wheels are flush up against the obstacle.
– Slowly pull the device across the obstacle one wheel at a time by
pulling on either side of the push handle, as necessary.

3.2.2 Transport

Definition of transport Transport is defined as a relocation that goes beyond the definitions
specified in Chapter 3.2.1 Relocation.

Preparing transportation  Observe the transport conditions, which correspond to the storage
conditions (see chapter 4.9 on page 72).
 Switch off the device.
 Unplug the power plug and secure the power supply cord on the
device.
 Remove the dialysis water inlet tube from the supply.
 Remove the drain tube from the drain.
 Individually protect the dialysis water inlet tube and drain tube
against contamination and leakage and secure them to the device.
Do not connect the dialysis water inlet tube and the drain tube to
each other.
 Disconnect CDS tubes. Individually protect the tubes against
contamination and leakage and secure them to the device.
 Transport all disinfectants separately in accordance with the
particular safety data sheet.
 Stop up the overflow.
 Remove the concentrate containers.

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 Remove any objects suspended from the IV pole and fully retract the
IV pole.
 Remove any consumables.
 Close the door.
 Remove all objects from the top tray (option) and the top of the
device.
 Remove the top tray (option).
 Insert the transport protection for the monitor support arm (see
chapter 10.9.1 on page 297).

Transporting the device  Release the brake.

 Using the push handle of the device, push it with its front side facing
forward. Watch out for obstacles.

Overcoming obstacles up to To avoid damaging or overturning the device, observe the following:
a height of 1 cm
 Grasp the device by the push handle and pull it until both rear wheels
are flush up against the obstacle.
 Slowly pull the device across the obstacle one wheel at a time by
pulling on either side of the push handle, as necessary.

For obstacles greater than  Call on a second person for support and securing.
1 cm and/or inclines greater
than 5°

Uneven flooring  Except on smooth, even floors, always carry the device when
moving it.

Transport in vehicles  In vehicles, the device should be transported preferably in the

upright position, with suitable protective padding.
If the device needs to be transported horizontally, use the tilting tool to
lay it on its back (see chapter 10.3.5 on page 277) and make sure it is
adequately padded for transport.

After transportation Completing transportation of a device that has not been

decommissioned
 Remove and store transport protection for the monitor support arm
(see chapter 10.9.1 on page 297).
 Mount the top tray (option).
 Remove the transport cap from the overflow.
 Connect all disinfectants.
 Connect the CDS tubing.
 Connect the dialysis water supply and water drain.
 Connect the power plug.

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 Carry out the technical safety checks with the following restrictions
(see TSC report on page 207).
– None of the steps under point 2 are necessary.
– The date of next inspection (TSC interval) must not be extended.
– Note on the TSC report that this is recommissioning after
transport.
– Note on the TSC report that none of the steps under point 2 were
carried out due to recommissioning after transport.
– Note on the TSC report that the date of next inspection (TSC
interval) was not extended.

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3.3 Disposal

3.3.1 Important information on disposal

Considerations for Read the information under "Considerations for working on the device"
working on the device (see chapter 2.5 on page 19).

Disposal Disposal means the irrevocable withdrawal of a device from routine

operation. Instructions for disposal are given in the latest Instructions for
Use, and must be followed.
The completion of the disposal must be recorded in the Medical Device
Register.

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4 Specifications

4.1 Dimensions and weight

Dimensions Height: approx. 168 cm (approx. 200 cm incl. IV pole)

Width: approx. 52 cm (on base incl. brake)
Depth: approx. 78 cm (approx. 90 cm incl. container holder)

Weight Empty weight including all options: approx. 115 kg

Safe working load: approx. 45 kg
Maximum total weight: approx. 160 kg (empty weight including all
options + safe working load = maximum total weight)

4.2 Identification label (device marking)

The identification label shown is only an example. Always go by the

information shown on the identification label affixed to the device itself.

14 1
13
2
12

11 3
10

8 7 6 5

1 Degree of protection against ingress of solid foreign objects and

liquids
2: Protection against touch and foreign bodies with a diameter
greater than 12.5 mm
1: Protection against vertical falling water drops
2 CE mark
3 Symbol for the marking of electrical and electronic equipment
4 Type of applied part (degree of patient safety): Type B
5 Non-ionizing electromagnetic interference

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6 Relative humidity (operating conditions)

7 Atmospheric pressure (operating conditions)
8 Operating temperature range
9 Manufacturer and year of manufacture
10 Power requirements (voltage / operating current)
11 Maximum total weight (weight empty plus safe working load)
12 Equipment code (EC)
13 Serial number
14 Type identification

4.3 Electrical safety

Classification according to IEC 60601-1

Degree of protection Protection class I

against electric shock

Applied part Depending on the method of treatment, the applied part consists of the
extracorporeal blood circuit, the dialysate and substituate circuits, and
all components having a permanent electrically conductive connection
with these circuits.

Type of applied part Type B

(degree of patient safety)

Degree of protection Drip-proof

against ingress of fluids

Leakage currents According to IEC 60601-1

4.4 Electrical power supply

Line voltage 110 V AC, 50 to 60 Hz, 15 A

120 V AC, 50 to 60 Hz, 14 A
220 to 230 V AC, 50 to 60 Hz, 11 A
240 V AC, 50 to 60 Hz, 10 A
(Always go by the line voltage, frequency and operating current
information specified on the identification label attached to the device
itself.)

Rechargeable battery Rechargeable lead-acid battery (maintenance-free)

24 V, 7 Ah
Power supply for audible alarm output in case of power failure for at
least one minute.

PC board battery Battery (see chapter 10.14.18 on page 475)

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PCB LP 1105-1 battery Battery (see chapter 10.14.2 on page 451)

PCB LP 1186 battery Battery (see chapter 10.14.16 on page 472)

VenAcc battery (option) Battery (see chapter 4.20 on page 85)

Power supply cord Length 3.5 m, unshielded

Power switch All-pole simultaneous disconnection

4.5 Fuses

Power switch 2 x G 16 A (thermal overcurrent circuit breaker), rear of power supply

unit

Rechargeable battery 1 x T 10 AL, 250 V; fuse in housing foot (rear)

Power plug fuse, UK Fuse (see chapter 10.10.3 on page 321)

version

PCB LP 1104 Fuses (see chapter 10.14.1 on page 449)

PCB LP 1106 Fuses (see chapter 10.14.3 on page 452)

4.6 Information on electromagnetic compatibility

(IEC 60601-1-2:2014)

Specifications refer to the requirements of IEC 60601-1-2:2014.

The data are valid for devices manufactured as of 2019.

4.6.1 Minimum distances between radiation source and medical electrical equipment

Medical electrical equipment is subject to special precautions with

respect to electromagnetic compatibility (EMC).

Warning
Risk for the patient as a result of a device malfunction
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to any part of the device, including cables specified
by the manufacturer. Otherwise, degradation of the performance of this
device could result.
 In the case of portable RF communications equipment, always
observe a distance of at least 30 cm from the device.

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Portable RF communications equipment may include the following

radiation sources (examples):
Cell phone, smartphone, tablet computer, cordless telephone,
notebook/laptop, wireless keyboard, wireless mouse, wireless speaker,
radio remote control (the device-specific radio remote control by the
manufacturer is not affected).

Warning
Risk for the patient as a result of a device malfunction
The use of electrical accessories and cables other than those specified
in the Instructions for Use can lead to an increase in electromagnetic
emissions or a reduction in electromagnetic immunity of the device.
 Only use accessories and cables approved by the manufacturer.

Warning
Patient hazard through electromagnetic incompatibility with other
devices
Electromagnetic interference from other devices can cause device
malfunctions.
 Do not operate the device in the immediate vicinity of other devices.
If operation in the immediate vicinity of other devices cannot be avoided:
 Monitor the device to verify that it is working properly.

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4.6.2 Guidance and manufacturer's declaration on EMC

 Electromagnetic emissions

Guidance and manufacturer's declaration – electromagnetic emissions

The 6008 device is intended for use in the electromagnetic environment specified below. The customer or the
user of the 6008 device should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emissions CISPR 11 Group 1 The 6008 device uses RF energy only for its internal function.
Class A Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Harmonic emissions Class A
IEC 61000-3-2 The 6008 device is suitable for use in all establishments other
than domestic and those directly connected to the public low-
Voltage fluctuations/flicker Complies voltage power supply network that supplies buildings used for
emissions IEC 61000-3-3 domestic purposes.
The emissions characteristics of this equipment make it suitable
for use in industrial areas and hospitals. If it is used in a
residential environment this equipment might not offer
adequate protection to radio-frequency communication
services. The user might need to take mitigation measures,
such as relocating or re-orienting the equipment.

 Electromagnetic immunity

Guidance and manufacturer's declaration – electromagnetic immunity

The 6008 device is intended for use in the electromagnetic environment specified below. The customer or the
user of the 6008 device should assure that it is used in such an environment.

Immunity test IEC 60601 test Compliance level Electromagnetic environment –

level guidance

Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, concrete or

discharge ±15 kV air ±15 kV air ceramic tile. If floors are covered with
IEC 61000-4-2 synthetic material, the relative humidity
should be at least 30 %.

Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that of a
transient/burst supply lines supply lines typical commercial or hospital
IEC 61000-4-4 ±1 kV for input / ±1 kV for input / environment.
output lines output lines

Surge ±1 kV line(s) to ±1 kV line(s) to Mains power quality should be that of a

IEC 61000-4-5 line(s) line(s) typical commercial or hospital
±2 kV line(s) to ±2 kV line(s) to environment.
earth earth

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Guidance and manufacturer's declaration – electromagnetic immunity

The 6008 device is intended for use in the electromagnetic environment specified below. The customer or the
user of the 6008 device should assure that it is used in such an environment.

Immunity test IEC 60601 test Compliance level Electromagnetic environment –

level guidance

Voltage dips, short 0 % UT for 0.5 cycle 0 % UT for 0.5 cycle In the event of power supply interruptions,
interruptions and at 0, 45, 90, 135, at 0, 45, 90, 135, the rechargeable battery of the 6008
voltage variations 180, 225, 270 and 180, 225, 270 and device temporarily takes over the supply
on power supply 315 degrees 315 degrees for parts of the system without delay.
input lines
0 % UT for 1 cycle 0 % UT for 1 cycle Mains power quality should be that of a
IEC 61000-4-11
typical commercial or hospital
70 % UT for 25 70 % UT for 25 environment.
cycles cycles

0 % UT for 250 0 % UT for 250

cycles (5 s) cycles (5 s)

Power frequency 30 A/m 30 A/m Power frequency magnetic fields should

(50/60 Hz) magnetic be at levels characteristic of a typical
field IEC 61000-4-8 location in a typical commercial or hospital
environment.

Note: UT is the AC mains voltage prior to application of the test level.

Conducted RF 3 Vrms 3 Vrms

IEC 61000-4-6 150 kHz to 80 MHz

6 Vrms in ISM bands 6 Vrms in ISM bands

between 150 kHz
and 80 MHz

Radiated RF 3 V/m 3 V/m

IEC 61000-4-3 80 MHz to 2.7 GHz

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

4.7 Operating conditions

Atmospheric pressure 700 hPa to 1060 hPa

Installation altitude Maximum installation altitude up to 3000 m

Relative humidity 30 % to 75 %, temporarily 95 %

Stability Maximum allowed inclination angle 5°

Inclination during Maximum allowed inclination angle 3°

operation

IV pole load capacity Maximum: 3 kg

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Dialysis water inlet 1.5 to 6.0 bar

pressure

Dialysis water inlet 5 °C to 30 °C

temperature for "Integrated hot rinse": 85 °C to 95 °C
for “Interface heat disinfection": 78 °C to 85 °C
For line voltages between 100 V and 120 V and low dialysis water inlet
temperatures, a restriction of the dialysate flow can be expected due to
the available power supply.
Example:
Line voltage 110 V, heater output 1200 W, dialysis water inlet
temperature 10 °C, dialysate temperature (target value) 37 °C,
= flow ≤ 800 ml/min

Dialysis water inlet rate Maximum 1.5 l/min; with an inlet pressure of 1.5 bar
for interface heat disinfection: minimum 500 ml/min at 1.5 bar

Water drain 0 up to 100 cm above floor, separate free fall for each device no less
than 2 cm. The water drain must be located at a lower level than the
dialyzer.

Temperature at water drain Maximum temperature at the water drain: 95 °C

Concentrate supply 0 to –100 mbar; maximum suction height 1 m

Central delivery system Pressure: 0.05 to 2.0 bar

(option) Temperature: 15 °C to 35 °C
Maximum flow: 35 ml/min

Operating temperature 15 °C to 35 °C
range

4.8 Consumption and energy data

The consumption and energy data represent the average values during
typical operation.
Environmental conditions: dialysis water inlet temperature 15 °C,
ambient temperature 22 °C.
For dialysis, the following data is assumed: ONLINE treatment with a
blood flow rate of 350 ml/min and an AutoFlow factor of 1.2 including
substituate preparation (factor 0.3) corresponding to a dialysate flow of
525 ml/min.
Unless stated otherwise, the consumption values below have been
determined for one operating hour each.
Specifications for cleaning programs are based on factory settings and
are applicable for each program run.
More data can be obtained from the manufacturer on request.

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Mean dialysis water Dialysis: approx. 31 liters

consumption Disinfection / heat disinfection: approx. 14 liters

Mean acid concentrate Dialysis (ACF, mixing ratio 1+44): approx. 0.7 liters
consumption

Mean bicarbonate Dialysis: approx. 650 g bicarbonate (bibag) every 4 h

consumption

Mean energy consumption Dialysis: approx. 0.68 kWh

Heat disinfection: approx. 0.80 kWh

Mean energy loss to the Dialysis: approx. 0.53 kWh

drain Heat disinfection: approx. 0.40 kWh

Mean energy loss to the Dialysis: approx. 0.15 kWh

environment Heat disinfection: approx. 0.40 kWh

4.9 Storage conditions

The device must be stored upright in a well-ventilated room with low

variations in temperature.

Temperature Without antifreeze: +5 °C to +60 °C

With antifreeze: –20 °C to +60 °C (new device / decommissioned
device)

Relative humidity 30 % to 75 %, temporarily 95 %

Atmospheric pressure 500 hPa to 1060 hPa

Maintenance of the built-in The rechargeable battery is maintenance-free.

rechargeable battery
Upon receipt of the system, charge the battery as follows:
 Use the power supply cord to connect the device to the power
supply.
 Switch the main power switch of the device to "on".
 Leave the device on for 10 hours.
If the device is not used, repeat this procedure every six months.

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4.10 External connection options

Warning
Risk of injury as a result of an electric shock
There is a risk of electric shock if the patient comes into contact with the
pins or contacts of the device's connectors, whether directly or indirectly
through the operator.
 Avoid touching connector pins or contacts during treatment.

Any additional equipment connected to this device must comply with the
relevant IEC or ISO standards (e.g., IEC 60950-1 for information
technology equipment).
Furthermore, all device configurations must comply with the
requirements for medical electrical systems (see IEC 60601-1 Section
16 and Annex I).
Connecting the device to an IT network that contains components not
installed and validated by the device manufacturer can introduce
unknown risks for patients, operators or third parties. These risks must
be identified, analyzed, evaluated and monitored by the responsible
organization. For assistance, consult IEC 80001-1 and Annexes H6 and
H7 of IEC 60601-1, for example.
Any modification to an IT network that has been installed and validated
by the device manufacturer can introduce new risks and therefore
requires a repeat analysis. Especially problematic activities:
– Changes to the IT network configuration
– Connection of additional components and devices to the IT network
– Removal of components and devices from the IT network
– Updating or upgrading components and devices in the IT network
Note that local laws take priority over the above mentioned normative
requirements. If you have any questions, please contact your local
service support organization.

LAN Interface for data exchange.

Electrically isolated by transformer.
Port: RJ 45
Length of network cable: 4 m
Shielded twisted pair cable: CAT5 or better

Service/diagnostics (Protected by cover!)

For in-house computer diagnostics.
Interface for data exchange (RS232).
24 V (max. 0.75 A)
Port: DSUB 15-pin
Length of serial cable: max. 3 m, shielded
Connection for AquaUNO/AquaC UNO H (single-station reverse
osmosis units)
Length of cables: adapter cable 0.3 m and control cable 3 m or 11 m

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Alarm output For the connection of an external alarm indicator (nurse call) (potential-
free alarm output, alternating contact, maximum 24 V / 24 W).
Port: 5-pin circular DIN connector
Length of cable: max. 3 m, unshielded
Only the cable from the accessories approved by the manufacturer
must be used.
Signal transmissions to external alerting systems (nurse call) are not
monitored by the device.
Connecting an external alerting system (nurse call) has no influence on
the visual and audible alarms on the device itself.

Warning
Risk for the patient as a result of ignored alarm signals
The reliability of alarm signal transmissions to external alarm systems
cannot be guaranteed, meaning that alarms can fail to be indicated
externally.
 Stay close enough to the device to be able to notice any alarms it
emits at all times.

Equipotential bonding line Length 4 m, unshielded

4.11 Operating programs

T1 test Automatic test of the operating and safety systems.

The T1 test is mandatory
– After power on (not following a power failure).
– After a cleaning program.

Preparation Defined by the venous optical detector located below the venous bubble
catcher.
Preparation is terminated as soon as the venous optical detector
detects dark in the cassette system.

Priming and rinsing the Minimum rinse volume 500 ml; automatic switching to Rinse mode if
cassette system fluid level detected in the level detector. Automatic raising of the fluid
level during the rinse phase.

Treatment Hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF),

ISO UF
Double-Needle, double-lumen catheter, Single-Needle, single-lumen
catheter
Bicarbonate citrate dialysis, bicarbonate acetate dialysis, acetate
dialysis
Dialysis time display
Maximum time: 12:00 hours
Resolution: 1 minute
Time base accuracy*: max. ±0.6 seconds per hour

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Reinfusion Reinfusion volume adjustable in the User setup.

Return to treatment possible.

Circulation (during the The Circulation function allows the patient to be disconnected from the
treatment) device for a short time during treatment.
During the circulation function, the device shows the following behavior:
– The blood flow rate is set to 100 ml/min.
– The heparin pump rate is reduced to 1 ml/h if the specified value
exceeds 1 ml/h.
– The alarm limits for the arterial and venous pressure are monitored
to ensure they cannot be set higher than the end of the scale.
– Ultrafiltration, ONLINEplus™ and OCM are inactive.
– The BTM and BVM control options are inactive.
– The interval mode of the BPM option is turned off.
– Alarms are not emitted with the VenAcc option.

Cleaning programs Free rinse / rinse / mandatory rinse:

Time (adjustable in the Service setup)
Temperature: approx. 37 °C
Flow rate: 600, 700 ml/min (adjustable in the Service setup)
Degreasing / cold disinfection, Cold disinfection:
Time (adjustable in the Service setup)
Temperature: approx. 37 °C
Flow rate: 600, 700 ml/min (adjustable in the Service setup)
Heat disinfection:
Time (adjustable in the Service setup)
Temperature: approx. 85 °C
Flow rate: 600, 700 ml/min (adjustable in the Service setup)
Integrated hot rinse:
Time (adjustable in the Service setup)
Temperature: approx. 85 °C
Flow: max. 600 ml/min
Flow rate for cool down rinse: 600, 700 ml/min (adjustable in the Service
setup)
Interface heat disinfection:
Time (adjustable in the Service setup)
Temperature (adjustable in the Service setup)
Temperature: 78 °C to 85 °C (dialysis water supply)
Flow: 400 ml/min; with AquaC UNO H 200 ml/min
Endless rinse:
Time not adjustable,
Temperature: approx. 37 °C
Flow rate: 600, 700 ml/min (adjustable in the Service setup)
In all programs:
Progress of the program (time-counting) is interrupted in the event of a
flow alarm.
The cleaning programs can be stopped.
A mandatory rinse is performed after the following programs:
– Disinfection
– Heat disinfection
– Endless rinse

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Flush (option) Rinsing of the water supply area

(* = essential performance characteristics for IEC 60601-1)

4.12 Dialysate circuit and safety systems

Blood leak detector Response threshold ≤ 0.35 ml blood loss per minute into the dialysis
fluid for a hematocrit of 0.32.
(flow rate 100 ml/min to 1000 ml/min).
If the dialysis fluid flow is switched off, blood leak alarms will be delayed.
The delay depends on the fluid volume in the rinse area between the
dialyzer and the blood leak detector (total fluid volume approx. 65 ml)
and the size of the membrane rupture in the dialyzer. The initiation of a
blood leak alarm also depends on the set UF rate.

Transmembrane pressure Display range: –100 to 400 mmHg

Resolution: 5 mmHg
Definition:

TMP = Pbo – (Pdi + Pdo) / 2 + offset

TMP = transmembrane pressure

Pbo = blood pressure on the outlet side of the dialyzer
Pdi = dialysate pressure on the inlet side of the dialyzer
Pdo = dialysate pressure on the outlet side of the dialyzer
Offset = correction of flow-dependent pressure drops

An alarm is generated if values are outside the display range.

A default value is used for the TMP offset.

Pressure holding test The pressure holding test is initiated as soon as the possibility of a
balancing error ≥ 400 ml arises, based on the TMP monitoring
calculation.
The pressure holding test detects leakages of ≥ 100 ml/h ±25 %.
When using the LOW VOLUME option:
The pressure holding test is initiated as soon as the possibility of a
balancing error ≥ 350 ml arises, based on the TMP monitoring
calculation.
In addition, the sensitivity of the pressure holding test is increased at a
dry weight ≤ 25 kg.
In this case, the detectable leakage is 0.5 % of the dry weight per hour.

Ultrafiltration* Selectable UF rate: 0 ml/h to 4000 ml/h (in increments of 10 ml/h)

Maximum rate can be limited in User setup in increments of 10 ml/h.
Pump volume accuracy: ±1 % (for Pdi > –500 mbar)
The ratio of UF rate to effective blood flow is monitored during the
treatment. If a discrepancy occurs a warning is displayed after about
10 seconds.

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UFC measurement At the beginning of the treatment, a measurement of the ultrafiltration

coefficient (UFC) of the connected dialyzer is performed. This value is
taken as initial value for different parameters (e.g., TMP monitoring).
If this measurement fails to be performed successfully 3 times in a row
because of malfunctions, a message will be displayed: TMP: UFC
measurement failed. The treatment can be continued! Please read the
information! – Repeat together with the corresponding information
about possible causes. As long as no current value is measured, a
default value is used for the calculation instead of the measured value.

Balancing* Accuracy: ±0.1 %, relative to the total dialysis fluid volume

Maximum balancing error

F = FUF + FBal

F = Maximum balancing error

FUF = Ultrafiltration error
FBal = Balancing error

Example:
Ultrafiltration error at 1000 ml in 1 hour: ±1% = ±10 ml/h
Balancing error at 30 liters of fluid flow in 1 hour with a dialysis fluid flow
rate of 500 ml/min: ±0.1 % = ±30 ml/h
Maximum balancing error:
F = FUF + FBal = (±10 ml/h) + (±30 ml/h) = ±40 ml/h

Degassing Method: negative pressure

Composition of the The composition of the dialysis fluid results from the volumetric mixing
dialysis fluid of dialysis water and the concentrates used. This is monitored by
(conductivity)* conductivity measurement.
Display range: 12.8 to 15.7 mS/cm
Resolution: 0.1 mS/cm
Accuracy: 0.1 mS/cm
Method:
Temperature-compensated electronic conductivity meter with
adjustable alarm limit window (±5 % around the target value).
Separate bicarbonate concentration monitoring using a fixed alarm limit
window (±25 % around the target value).

Concentrates Entering concentration types.

Adjustment range: 125 to 151 mmol/l, depending on the concentrate
used, ±10 % of the base value.
Bicarbonate adjustment range: corresponds to ±8 mmol/l

bibag Bicarbonate concentrate preparation from the bibag

Temperature range: 15 to 35 °C

Dialysate temperature* Adjustment range: (target temperature) 34.0 °C to 39.0 °C

Resolution: 0.5 °C
Measuring accuracy: +0.2 °C / –0.5 °C
If the temperature falls below 33 °C or exceeds 40 °C an alarm is
generated.

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Depending on the ambient conditions, the temperature at the dialysate

inlet port may drop by up to 5 °C if the dialysate flow is < 200 ml/min.

Dialysate flow* Display range: 100 to 1000 ml/min

Resolution: 100 ml/min
Accuracy: ±20 ml/min or –10 %
(the smaller value applies)
Target values: 100 to 1000 ml/min
If necessary, the dialysate flow rate will be limited in relation to the
current substitution rate. The sum of the dialysate flow rate and the
substitution rate will not exceed 1000 ml/min.
Measured by means of time pulse monitoring and balancing chamber
volume
AutoFlow: The AutoFlow function automatically regulates the dialysate
flow, depending on the blood flow rate.
Entering a specific factor for AutoFlow changes the ratio of the selected
blood flow rate to the dialysate flow. The default value of the AutoFlow
factor in the User setup is 1.2 for HDF and 1.5 for HD.
Example:
Blood flow rate: 350 ml/min, HDF, factor: 1.2
Dialysate flow = 420 ml/min
The factor (AutoFlow) can be modified in the User setup and in the
Dialysate menu.
These particular default values achieve the optimum balance between
the dialysis quality (Kt/V) and the resources used (dialysis water,
concentrates, energy).
If the default values are exceeded, the use of resources is
disproportionately high as compared with the dialysis quality obtained.
An entry below the default value in either case will result in a
disproportionately poorer dialysis quality, compared with the resources
saved.
EcoFlow: Dialysate flow is automatically reduced to 100 ml/min in
Preparation.
The following must be observed regarding the dialysate flow:
If the dialysis water inlet rate is not sufficient for achieving the maximum
dialysate flow of 1000 ml/min, the permitted adjustment range will be
limited accordingly.

Rinse temperature Rinsing:

Target temperature: 37 °C
Resolution: 0.5 °C
Measuring accuracy: ±0.2 °C
Integrated hot rinse:
Target temperature: 85 °C
Resolution: 0.5 °C
Measuring accuracy: ±2.0 °C
Endless rinse:
Target temperature: 37 °C
Resolution: 0.5 °C
Measuring accuracy: ±0.2 °C

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Disinfection temperature Cold disinfection:

Target temperature: 37 °C
Resolution: 0.5 °C
Measuring accuracy: ±0.2 °C
Degreasing / cold disinfection:
Target temperature: 37 °C
Resolution: 0.5 °C
Measuring accuracy: ±0.2 °C
Heat disinfection:
Target temperature: 85 °C
Resolution: 0.5 °C
Measuring accuracy: ±2.0 °C
Interface heat disinfection:
depends on the dialysis water inlet temperature; temperature not
monitored.

Rinse and disinfection flow Target value: 600 ml/min or 700 ml/min (depending on the settings in
the Service setup)
(During the recirculation phase in disinfection the flow is always
600 ml/min)

Concentration of Citrosteril, Diasteril, Puristeril 340, Puristeril plus: 4 %

disinfectant Sporotal 100: 3 %

Flow alarm Depends on the programmed flow

(* = essential performance characteristics for IEC 60601-1)

4.13 Extracorporeal blood circuit and safety systems

Arterial pressure Display range: -300 to +300 mmHg

measurement Resolution: 5 mmHg
Accuracy: 7 mmHg (typical)
Venous optical detector is not detecting blood:
Alarm limits, arterial alarm limit window size: –300 to +300 mmHg
Venous optical detector is detecting blood:
Alarm limits, arterial alarm limit window size: +40 to +200 mmHg
Default value adjustable in the User setup,
factory setting 100 mmHg

Blood flow* Delivery rate: 30 to 600 ml/min

Resolution: 10 ml/min
For LOW VOLUME option: resolution 5 ml/min, for delivery rates
≤ 100 ml/min
System accuracy of the delivered blood volume: ±10 %
(Single-Needle operation: –10 to +15 %)
over the complete duration of the treatment, for typical treatment
situations

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Warning
Risk for the patient as a result of insufficient detoxification
If the arterial pressure before the blood pump reaches extreme negative
values, the blood flow may be reduced, which will impair the
effectiveness of the treatment.
 Take suitable measures to prevent extremely negative arterial
pressures at the access.

Pump segment diameter: 7.1 mm

Blood pump stop alarm: 60 seconds
(180 seconds in Single-Needle operation – option).

Pre-filter pressure Accuracy: 20 mmHg (typical)

monitoring Venous optical detector is not detecting blood:
no monitoring
Venous optical detector is detecting blood:
limit value monitoring for 950 mmHg, or 600 mmHg after preparation
with NaCl solution
(not adjustable).

Venous pressure Display range: –100 to +500 mmHg

measurement Resolution: 5 mmHg
Accuracy: 7 mmHg (typical)
Venous optical detector is not detecting blood:
Alarm limits, venous alarm limit window size: –100 to +500 mmHg
Venous optical detector is detecting blood:
Alarm limits, venous alarm limit window size: +40 to +200 mmHg
Default value adjustable in the User setup,
factory setting 100 mmHg
adjustable over a range of +20 to +500 mmHg
(adjustable in the User setup from –100 to 500 mmHg).

Level detector Method:

Capacitive measurement

Optical detector Method: infrared transmission

Distinguishes between
Optical detector is not detecting blood (rinse solution or air in the
cassette system)
Optical detector is detecting blood (blood in the cassette system)

Air bubble detector Method:

(arterial/venous) ultrasonic transmission measurement on the line
Sensitivity:
– Air bubbles of ≥ 25 µl volume
– Blood foam (air/blood mixture)
– Microbubbles

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Air alarm:
– Blood flow rate < 100 ml/min:
Air bubble of ≥ 25 µl volume
Blood foam
Microbubbles (venous only)
– Blood flow rate ≥ 100 ml/min:
10 air bubbles (5 for LOW VOLUME) with an air bubble volume of
< 100 µl each
or 1 air bubble with an air bubble volume of ≥ 100 µl,
Blood foam
Microbubbles (venous only)
The specified data is based on a worst-case assumption, at a blood flow
rate of 0 to 600 ml/min using the cassette system approved for the
device.

Heparin pump Delivery rate: 0.5 to 10 ml/h

Resolution: 0.1 ml/h
Accuracy: ±1 ml or ±7 % of cumulative heparin (the higher value
applies) at pressures from 0 to +1.27 bar.
(Applies only to the disposable syringes listed in the Instructions for
Use. When using other syringes the tolerance may differ.)
Stop time: 0 min to 9 hrs 59 min
Resolution: 1 min
Bolus administration: 1.0 to 20.0 ml
Resolution: 0.1 ml

Audible alarm Adjustment range of the loudness of the audible alarm:

Loudness range: 50 to 75 dBA (+/–10 %)
(adjustable in the SYSTEM menu, in the Loudness submenu).
Factory setting: ≥ 65 dBA
(* = essential performance characteristics for IEC 60601-1)

4.14 DIASAFE® plus

Life of the filter No more than 12 weeks and/or 100 treatments

(filter 1 / filter 2)
The number of remaining treatments is displayed in the cleaning
programs and under Status  Device info.
The device monitors filter life and issues a warning when a filter change
is necessary.
When ONLINEplus™ is used, the functions of ONLINEplus™ will be
disabled when the life of the filter has been exceeded.

Cleaning/disinfection Up to 11 degreasing programs can be performed during the life of the

(filter 1 / filter 2) filters. After that, no more degreasing programs can be performed
during the remaining life of the filters. All other cleaning/disinfection
programs for the device remain available.
The number of remaining degreasing procedures is displayed in the
cleaning programs and under Status  Device info.

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4.15 OCM

Measuring accuracy of the clearance: ±6 % standard deviation

Shortest measuring interval: 25 min
Time scale of the display: 10 s

4.16 ONLINEplus™

Sub rate (substitution With AutoSub plus (automatic substitution): 25 to 400 ml/min (automatic
rate)* control of the sub rate, depends on the continuously calculated
utilization of the dialyzer)
With manual substitution: 25 to 600 ml/min (maximum adjustable sub
rate, depending on treatment procedure, blood flow rate, UF rate,
hematocrit)
Resolution: 1 ml/min
Sub goal (substitution goal): depends on treatment parameters
Accuracy: ±10 %
Sub volume (substitution volume):
Resolution: 0.1 liter
Spring-loaded line rollers, fully occluding (with the prescribed cassette
system)

Substituate temperature* Adjustment range: see dialysate temperature (see Dialysate

temperature* on page 77)
Depending on the ambient temperature, the substituate temperature
may be lower than the set dialysate temperature due to cooling along
the way. If the dialysate flow rate is less than 200 ml/min or if the
substituate flow rate is very low, the drop in temperature may be more
than 5 °C.
(* = essential performance characteristics for IEC 60601-1)

Bolus rates and blood flow

rates with automatic bolus Set blood flow rate Blood flow rate with Bolus rate in
for "Standard" treatment in ml/min bolus in ml/min ml/min

600 to 150 50 Blood flow rate – 50

140 50 100

130 50 100

120 50 100

110 50 100

100 50 100

90 50 100

80 50 100

70 50 100

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Set blood flow rate Blood flow rate with Bolus rate in
in ml/min bolus in ml/min ml/min

60 50 100

50 50 100

40 40 100

30 30 100

0 0 100

Bolus rates and blood flow

rates with automatic bolus Set blood flow rate Blood flow rate with Bolus rate in
for "LOW VOLUME" in ml/min bolus in ml/min ml/min
treatment
600 to 150 50 Blood flow rate – 50

140 40 100

130 30 100

120 30 90

110 30 80

100 30 70

90 30 60

80 30 50

70 30 40

60 30 30

50 30 30

40 30 30

30 30 30

0 0 30

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4.17 Network

Warning
Risk of blood loss as a result of an unavailable device
Risk for the patient as a result of insufficient detoxification
Excessive network loads can cause the device to malfunction or
become unavailable.
 The network operator must protect the device from excessive
network loads (e.g., caused by accumulation of broadcast
messages or port scans). If necessary, the connection to the
network must be established via a router or a firewall, for example.

Warning
Risk for the patient as a result of corrupted data
Data corruption or data loss caused by the network and the server
software cannot be detected by the device. This can lead to
malfunctions.
 The system installer must ensure that device data is processed
securely, e.g., in PC software applications.
 The network operator must ensure that any data transferred without
encryption is protected.

Warning
Risk for the patient as a result of ignored alarm signals
The reliability of alarm signal transmissions to external alarm systems
cannot be guaranteed, meaning that alarms can fail to be indicated
externally.
 Stay close enough to the device to be able to notice any alarms it
emits at all times.

Any additional equipment connected to this device must comply with the
relevant IEC or ISO standards (e.g., IEC 60950-1 for information
technology equipment).
Furthermore, all device configurations must comply with the
requirements for medical electrical systems (see IEC 60601-1 Section
16 and Annex I).
Connecting the device to an IT network that contains components not
installed and validated by the device manufacturer can introduce
unknown risks for patients, operators or third parties. These risks must
be identified, analyzed, evaluated and monitored by the responsible
organization. For assistance, consult IEC 80001-1 and Annexes H6 and
H7 of IEC 60601-1, for example.
Any modification to an IT network that has been installed and validated
by the device manufacturer can introduce new risks and therefore
requires a repeat analysis. Especially problematic activities:

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– Changes to the IT network configuration

– Connection of additional components and devices to the IT network
– Removal of components and devices from the IT network
– Updating or upgrading components and devices in the IT network
Note that local laws take priority over the above mentioned normative
requirements. If you have any questions, please contact your local
service support organization.

4.18 Radio (option) – in monitor

The Radio (wireless) option must be installed in the monitor of the

device if the VenAcc option is used.

Radio unit Radio frequency: 2.46 GHz

Transmission power: 0.25 mW (EIRP)

4.19 Single-Needle (option)

Stop alarm 180 seconds in Single-Needle operation.

Blood pump

Single-Needle stroke 10 to 60 ml in increments of 5 ml

volume

Auto-Single-Needle flow +20 % (adjustable in the User setup)

Single-Needle flow Delivery rate: 30 to 600 ml/min

Resolution: 10 ml/min

4.20 VenAcc (option) monitoring unit

Dimensions and weight Dimensions:

Height: approx. 8.5 cm
Width: approx. 5.5 cm
Depth: approx. 1.5 cm
Weight:
approx. 73 g (with contact protection cover, sensor cable with connector
and clamp, fixing clip)

Electrical safety Type of applied part (degree of patient safety): Type CF

Applied part The fluid sensor is the applied part of the VenAcc.

Electrical power supply Lithium battery: CR 2450, 3 V (replaceable), manufacturer: Renata

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IP protection IP22

Radio unit Radio frequency: 2.46 GHz

Transmission power: 0.25 mW (EIRP)

Material PP, TPE-S

(monitoring unit, cable)

4.21 BPM (option)

The BPM has been validated in clinical tests in accord with the
objectives of ISO 81060-2.

Electrical safety Type of applied part (degree of patient safety): Type CF,
(blood pressure cuff) defibrillator-proof

Blood pressure Cuff pressure measurement range:

10 to 280 mmHg
Display range
– Systolic: 60 to 250 mmHg**
– Diastolic: 40 to 200 mmHg**
– MAP: 45 to 235 mmHg**
Resolution: 1 mmHg

Accuracy of blood Mean value deviation: ≤ ±5 mmHg

pressure measurement
Standard deviation: ≤ 8 mmHg

Pulse Display range: 40 to 200 1/min**

Resolution: 1/min
(** Values can vary depending on equipment variant.)

4.22 BTM (option)

Required blood flow for ≥ 250 ml/min

accurate BTM function (The measuring and control functions of the BTM are deactivated if
blood flow rates are < 100 ml/min.)

Typical operation Blood flow: 250 ml/min to 600 ml/min

Blood temperature: 34 °C to 37.5 °C
Ambient temperature: 20 °C to 35 °C
Recirculation: 5 % to 35 %

Temperature Accuracy of the fistula temperatures relative to different blood

measurement temperatures (33 °C to 39.5 °C) if correct room temperature (±1 °C) is
set in User setup: ±0.5 °C

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 Chapter 4: Specifications

Error in fistula temperatures per °C error in the set room temperature

0.08 °C (with a blood flow rate of 100 ml/min)
0.03 °C (with a blood flow rate of 300 ml/min)
Measurement accuracy of body temperature changes during typical
operation: ± 0.2 °C

Recirculation Accuracy of recirculation measurement

measurement (during typical operation and at 2.5 °C venous bolus amplitude): ±2 %
Maximum bolus amplitude: –3 °C or +3 °C
Maximum duration of the bolus: up to 10 min

Body temperature control Permitted range of target values for body temperature change rate:
–0.5 °C/h to +0.5 °C/h
Dialysate temperature range used by the BTM:
– Minimum dialysate temperature: 35.5 °C
– Maximum dialysate temperature: 37.0 °C to 38.0 °C
(adjustable in the User setup)

Recording treatments with BTM treatments can be recorded as follows (resolution 1 minute):
control functions
Enable the BTM charts in the User setup.
Relevant control parameters: BTM T control
Events: BTM events
The charts for the last 3 treatments are stored on the PatientCard.
In the event of a short-term power failure during treatment, the built-in
rechargeable battery protects the current treatment data from loss.

4.23 BVM (option)

The following accuracy information applies after successful calibration

of the BVM cuvette during Preparation.

Relative blood volume 55 to 115 %

Accuracy within the range 70 to 105 %, ±1.7 % absolute (standard
deviation)
(The accuracy of the blood volume measurement can be affected by
extremely high lipid concentrations (e.g., triglycerides > 400 mg/dl).)

Hemoglobin 7 to 17 g/dl
Accuracy: ±0.8 g/dl
(The accuracy of hemoglobin measurement is valid only for plasma
protein concentrations ranging between 60 and 85 g/l.)

Hematocrit 20 to 55 %
Accuracy: ±2.9 % of Hct
(The accuracy of hematocrit measurement is valid only for plasma
protein concentrations ranging between 60 and 85 g/l.)

Recording treatments with BVM treatments can be recorded as follows (resolution 1 minute):
control functions

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Chapter 4: Specifications

 Enable the BVM charts in the User setup.

Relevant control parameters: RBV, UF rate
Events: BVM events
The charts for the last 3 treatments are stored on the PatientCard.
In the event of a short-term power failure during treatment, the built-in
rechargeable battery protects the current treatment data from loss.

4.24 Materials used

 Materials used – device

Materials shown on the gray background come into contact with dialysis
water, dialysis fluid, or dialysis fluid concentrate.

Plastics and cast resins

Abbreviation Material

EPDM Ethylene propylene diene monomer

rubber

FPM (FKM) Fluorocarbon rubber

PFA Perfluoroalkoxy alkane

PAEK Polyaryletherketone

PPSU Polyphenylsulfone

PVDF Polyvinylidene difluoride

PTFE Polytetrafluoroethylene

PP Polypropylene

PES Polyethersulfone

PPO Polyphenylene oxide

PPS Polyphenylene sulfide

SI Silicone

TPE Thermoplastic elastomer

PBT/ABS Polybutylene terephthalate / acrylonitrile

butadiene styrene

ABS Acrylonitrile butadiene styrene

PA Polyamide

PC/ABS Polycarbonate / acrylonitrile butadiene

styrene

POM Polyoxymethylene

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 Chapter 4: Specifications

Abbreviation Material

EPDM+PP Ethylene-propylene terpolymer /

polypropylene

PC Polycarbonate

PUR Polyurethane

PS Polystyrene

Metals, glass, graphite,

ceramics Abbreviation Material

Glass Glass

Graphite Graphite

Ceramics Ceramics

Stainless steel Stainless steel

Ti Titanium

Stainless steel Stainless steel

St Steel

Fe Iron

Al Aluminum and aluminum alloys

CuZn39 Brass

Magnet Samarium-cobalt magnet

Magnet NdFe magnet

Electrical equipment
Abbreviation Material

Motors Copper

Connectors

Tin

Connectors Copper and tin

Glass fiber reinforced thermoplastic

Transformers Potting compound PU

Polyester, polyurethane

Copper

Polyester resin

Ferrite cores

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Abbreviation Material

Microswitches Polyacetal

Glass fiber reinforced polyamide

Silicone

Silver, gold

Brass

Beryllium copper

Cables Copper

PVC

Teflon

Electronics PCB base material

Fiberglass epoxy resin

Ferrite cores

Lithium batteries

Lead-acid rechargeable batteries

LCD screen

Equipment
Abbreviation Material

Adhesives Loctite 3321

UHU Plus Endfest

Scotchweld DP 499

Insulating material Polyethylene

Lacquers Acrylic enamel

Screening lacquer – copper conductive

lacquer

PUR structural lacquer

Grease Unisilkon

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5 Setup / service program

5.1 SYSTEM menu

SYSTEM menu

Parameters in the SYSTEM menu

Date Parameters (see chapter 5.1.1 on page 92)

Time Parameters (see chapter 5.1.1 on page 92)

Loudness Parameters (see chapter 5.1.1 on page 92)

Brightness Parameters (see chapter 5.1.1 on page 92)

Graphic time scale Parameters (see chapter 5.1.1 on page 92)

Timer Parameters (see chapter 5.1.1 on page 92)

Remaining time Parameters (see chapter 5.1.1 on page 92)

Reminder time Parameters (see chapter 5.1.1 on page 92)

Reminder text Parameters (see chapter 5.1.1 on page 92)

SERVICE menu Menu description (see chapter 9.1 on page 221)

Flow diagram menu

CALIBRATE menu
DIAGNOSTICS menu
SETUP menu
MODULE menu
VARIOUS menu
UPDATE menu

USER SETUP menu Menu description (see chapter 5.3 on page 108)

APPLICATIONS menu Menu description (see chapter 5.4 on page 133)

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 Selecting the SYSTEM menu

The device is switched on.

 Select the SYSTEM menu.

 Setting the SYSTEM menu

 Select the required function.

 Make any necessary changes.
– Save with the OK field.
– Select default values (factory settings) with the RESET field.

5.1.1 Parameters in the SYSTEM menu

Warning
Risk for the patient as a result of ignored alarm signals
If the volume of the audible alarm is lower than the ambient noise level,
the audible alarm output may go unnoticed.
 Use a setting for the audible alarm volume that is higher than the
ambient noise level.

SYSTEM menu  Parameter in the SYSTEM menu

Parameter Additional information Value range or Resolution Default value

selectable options

 Date Can only be changed with – – Day, month, year

ServiceCard.

 Time Can only be changed in Standby. 00:00 to 23:59 h:min 0:01 h:min –

 Loudness Loudness of the audible alarm. 1 to 9 1 6

Depending on the setting in the
Service setup, the loudness can only
be adjusted when the UserCard is
inserted.

 Brightness Brightness of screen saver and 0 to 10 1 10

operating status indicator.

 Graphic time scale Auto: – Auto – Auto

The last time segments of the – 10 min
respective treatment will be – 20 min
displayed.
– 30 min
– 1h
– 2h
– 4h
– 6h
– 10 h

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SYSTEM menu  Parameter in the SYSTEM menu

Parameter Additional information Value range or Resolution Default value

selectable options

 Timer Field for starting the timer. This – – I/O

function allows you to set an
independent timer. You can also
define a message to appear on the
screen when the timer has ended.
– Displays a reminder for the
operator in the form of an info
message after a set time.
– Must only be used for displaying
non-critical reminders.

 Remaining time – 00:00 to 23:59 h:min 0:01 h:min –

 Reminder time – 00:00 to 23:59 h:min 0:01 h:min –

 Reminder text For entering a message text. This text – – –

will be displayed after the set time has
elapsed. The time and the reminder
text are deleted at the end of the
treatment, as well as in the event of a
power failure if the battery is empty.

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5.2 SETUP menu (Service setup)

SETUP menu

Settings Hydraulics Parameters (see chapter 5.2.1 on page 95)

Settings EBM Parameters (see chapter 5.2.2 on page 97)

Settings Air bubble detector Parameters (see chapter 5.2.3 on page 98)

Define cleaning parameters Parameters (see chapter 5.2.4 on page 99)

Miscellaneous Parameters (see chapter 5.2.5 on page 101)

Network Parameters (see chapter 5.2.6 on page 103)

BTM (option) Parameters (see chapter 5.2.7 on page 105)

BVM (option) Parameters (see chapter 5.2.8 on page 105)

Radio (option) Parameters (see chapter 5.2.9 on page 105)

AFM (option) Parameters (see chapter 5.2.10 on page 106)

Software options Parameters (see chapter 5.2.11 on page 106)

 Selecting the SETUP (Service setup) menu

Device is switched on and the T1 test of the EBM has been performed.
 Insert the ServiceCard.

Note
No access rights due to invalid ServiceCard
After successfully completing the appropriate training for the 6008
device, an expiry date is explicitly set for this device on the ServiceCard.
When the expiry date of the ServiceCard has been exceeded, the
following message is issued when the ServiceCard is inserted: Card not
valid, as expiry date has been exceeded. – OK
 When the expiry date has been exceeded, select the OK field and
have the expiry date of the ServiceCard extended.

 Select the SYSTEM menu.

 In the SYSTEM menu, select the SERVICE field.

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Message: Remove ServiceCard!

 Remove the ServiceCard.
 In the SERVICE menu, select the SETUP field.

 Switching between the SETUP (Service setup) menu and the USER SETUP menu

You can change over from the Service setup to the User setup, as well
as from the User setup back to the Service setup.
 Select the appropriate field:
– In the Service setup, select the User setup field.
– In the User setup, select the SETUP field (for Service setup).

 Setting the SETUP (Service setup) menu

In the SETUP menu

 Select the required function.
 Make any necessary changes.
– Save with the OK field.
– Select default values (factory settings) with the RESET field.
– With the C field, select the value previously stored.

5.2.1 Settings Hydraulics menu option

SETUP menu  Settings Hydraulics menu option

Parameter Additional information Value range or Resolution Default value

selectable options

Device standards

 Device standards Not adjustable – – – DIASAFE

– ONLINE plus
– Standard

 Filter 1 – – Available – Available with

– Equilibration DIASAFE and
chamber ONLINE plus

 Filter 2 – – Available – Available with

– Filter not present ONLINE plus

Water inlet tube

 Flush Not adjustable – – – Yes

– No

 Length Only displayed if Flush is set to Yes. 1.0 to 5.0 m 0.1 m 3.0 m

 Internal diameter Only displayed if Flush is set to Yes. 3 to 20 mm 1 mm 6 mm

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SETUP menu  Settings Hydraulics menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 T1 test flow If the heater rod is a 110 V or 120 V – 1000 ml/min – 800 ml/min
version, the T1 test flow is limited to – 900 ml/min
800 ml/min. – 800 ml/min
– 700 ml/min
– 600 ml/min
– 500 ml/min

Heater rod

 Line voltage – – 230/240 V – 230/240 V

– 120 V
– 110 V
– 100 V (Selection
not possible)

 Installation altitude This setting affects the heater output – over 2000 m – over 2000 m
in the cleaning programs, the – below 800 m
calibration of the pressure – 800-1400 m
transducers and the degassing, as
well as the fast lower arterial scale – 1401-2000 m
end.
Consider different diameters of
degassing orifices (see
chapter 10.12.5 on page 418).
After changing the installation
altitude, the cassette sensors must be
calibrated (see chapter 9.4.12 on
page 238).

 CDS free rinse During the disinfection program, – Yes – Yes

concentrate is drawn in from the – No
connected CDS lines for a specified
period to prevent crystallization.
Close off unused connections with a
transport cap or deactivate them with
an appropriate modification kit.

Calcification

 Drop in Reduction of Prescr. Bic during – Yes – Yes

bicarbonate Preparation. – No

Auto calibration

 Degassing (P01) Automatic calibration of the – Yes – Yes

degassing pressure (see – No
chapter 9.4.3.4 on page 230).

 Blood leak Automatic calibration of the blood leak – Yes – Yes

voltage (see chapter 9.4.8.1 on – No
page 234).
Only adjustable with the old blood
leak detector.

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5.2.2 Settings EBM menu option

SETUP menu  Settings EBM menu option

Parameter Additional information Value range or Resolution Default value

selectable options

Motor type

 Blood pump – Premotec – Premotec

 ONLINE plus – Premotec – Premotec

 Heparin pump – – Available – Available

– Not available

Bubble catcher

 Last fill level – 5 to 15 ml 1 ml 7 ml

 SN switching point Only with Single-Needle (option). 21 to 35 ml 1 ml 28 ml

ONLINE

 BFAC Burden-free auto-substitution concept – Yes – Yes

– No

 Control goal Variable that changes the target value +80 % to +120 % 1% 100 %
of the dialyzer load.

 ONLINE closed – – Yes – Yes

circuit – No

Emptying the cassette

 Automatic Entirely: – Entirely – Entirely

emptying cassette system, dialyzer and, if – Partially
applicable, bibag
Partially:
substituate channels of the cassette
system, dialyzer and, if applicable,
bibag

Correcting the level in the venous bubble catcher, if necessary

Note
The values set under Bubble catcher in the table above may only be
changed when necessary.

Problems If alarms occur due to an increase in foaming in the venous bubble

catcher, or if the level is always too high, the following setting can be
selected.

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Correct level in the venous At the end of Preparation, the level must be just above the
bubble catcher during Single-Needle cassette valve.
Double-Needle treatment

Level

Altering the level in the The level can be changed between 5 ml and15 ml under "Last fill level".
venous bubble catcher 1 ml corresponds to a level alteration of approx. 1 mm.

5.2.3 Settings Air bubble detector menu option

Warning
Risk for the patient as a result of a device malfunction
The air bubble detector must be set with the default values from the
following table. Other values may only be set on the manufacturer’s
written instruction.
 Set the default values from the following table.
 Check the settings after a software update.

SETUP menu  Settings Air bubble detector menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Events – 0 to 1200 1 500

with LOW VOLUME – 0 to 1200 1 500

 Rate – – – 1000 1/min

with LOW VOLUME – – – 1000.0 1/min

 Events (absolute) – 0 to 1350 1 375

with LOW VOLUME – 0 to 1350 1 150

 Rate – – – 25 1/min

with LOW VOLUME – – – 10.0 1/min

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5.2.4 Define cleaning parameters menu option

5.2.4.1 Define cleaning parameters menu option (page 1)

SETUP menu  Define cleaning parameters menu option (page 1)

Parameter Additional information Value range or Resolution Default value

selectable options

 Cleaning programs – – Heat disinfection – Heat disinfection

– Rinse
– Cold disinfection
– Degreasing / cold
disinfection
– Endless rinse
– Integrated hot
rinse + cool down
rinse
– Integrated hot
rinse
– Interface heat
disinfection

 Disinfection port 1 Suction via disinfectant connector – Diasteril (6000 ml) – – Diasteril (6000 ml)
H20 – Citrosteril
Citrolean disinfectant: The Citrolean (5000 ml)
disinfectant is approved exclusively – Puristeril 340
for the Korean market as an (4400 ml)
alternative to the Citrosteril
disinfectant. All warnings and – Puristeril Plus
(5000 ml)
descriptions concerning the Citrosteril
disinfectant apply to the Citrolean
disinfectant.

 Disinfection port 2 Suction via disinfectant connector – Sporotal 100 – Sporotal 100
H35 (1000 ml) (1000 ml)
– -----

Suction from the Suction via bicarbonate suction tube – Sporotal 100 – Sporotal 100
front – ----

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5.2.4.2 Define cleaning parameters menu option (page 2)

SETUP menu  Define cleaning parameters menu option (page 2)

Parameter Additional information Value range or Resolution Default value

selectable options

 Cleaning flow rate – – 700 ml/min – 700 ml/min

– 600 ml/min

Parameter Minimum time by Cleaning flow rate value Maximum time Resolution

600 ml/min 700 ml/min

 Free Rinse – 0 CDS: 0:08 h:min – 0 CDS: 0:08 h:min 1:00 h:min 0:01 h:min
– 1 CDS: 0:09 h:min – 1 CDS: 0:09 h:min
– 2 CDS: 0:10 h:min – 2 CDS: 0:10 h:min

 Integr. hot rinse 0:24 h:min 0:23 h:min 1:00 h:min 0:01 h:min

 Cool down rinse 0:08 h:min 0:08 h:min Cannot be set.

 Rinse – 0 CDS: 0:10 h:min – 0 CDS: 0:10 h:min 10:00 h:min 0:01 h:min
– 1 CDS: 0:10 h:min – 1 CDS: 0:10 h:min
– 2 CDS: 0:10 h:min – 2 CDS: 0:10 h:min

 Degreasing 0:16 h:min 0:16 h:min 1:00 h:min 0:01 h:min

 Disinfection 0:10 h:min 0:10 h:min 1:00 h:min 0:01 h:min

 Mandatory rinse by value under USER Manual: Manual: 1:00 h:min 0:01 h:min
SETUP  Cleaning  Check for residual – 230/240 V: – 230/240 V:
disinfectant and by value under SETUP  0:23 h:min 0:21 h:min
Settings Hydraulics  Line voltage
– 120 V or 110 V: – 120 V or 110 V:
0:26 h:min 0:26 h:min
Automatic: Automatic:
– 230/240 V: – 230/240 V:
0:24 h:min 0:22 h:min
– 120 V or 110 V: – 120 V or 110 V:
0:28 h:min 0:27 h:min

 Heat disinfection by value under SETUP  – 230/240 V: – 230/240 V: 1:00 h:min 0:01 h:min
Settings Hydraulics  Line voltage 0:14 h:min 0:14 h:min
– 120 V or 110 V: – 120 V or 110 V:
0:21 h:min 0:19 h:min

 Mandatory rinse by value under USER – Manual: – Manual: 1:00 h:min 0:01 h:min
SETUP  Cleaning  Check for residual 0:21 h:min 0:19 h:min
disinfectant – Automatic: – Automatic:
0:23 h:min 0:20 h:min

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Parameter Additional information Value range or Resolution Default value

selectable options

Integrated hot rinse

 Heater The heater regulation can be – On – On

switched on or off during the – Off
integrated hot rinse.
Off (without temperature monitoring):
– Energy saving
– Reduced wear of the gear pumps
On:
– Thermal germ reduction

Interface heat disinfection

 Temperature at the – 78 °C to 85 °C 1 °C 82 °C
interface

Parameter Minimum time by value under USER Maximum time Resolution

SETUP  Miscellaneous  Reverse
osmosis unit

---- With AquaUNO /

Without single AquaC UNO H
station osmosis
system

 Interface heat disinfection for Temperature 0:53 h:min 0:53 h:min 2:00 h:min 0:01 h:min
at the interface value = 82 °C

5.2.5 Miscellaneous menu option

SETUP menu  Miscellaneous menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Date Current date – – –

 Time Current time 00:00 to 23:59 0:01 –

 Language (see chapter 5.2.5.1 on page 102) – German – –

– English
– Additional
languages

 Device name – – – –

 Can T1 test be The submenu item Can T1 test be – No – No

skipped? skipped? may only be set to "Yes" for – Yes
servicing.
After servicing, Can T1 test be
skipped? must be set to "No" again.

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SETUP menu  Miscellaneous menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Loudspeaker test – – Yes – Yes

– No

 Screen monitoring – – No – No
– Yes

 Recording Data recorder – Yes – Yes

– No

 Recording rate Data recorder – Low – Low

– High

 CardNetLog Logs access to network interface and – No – No

patient card. – Yes

 Loudness control Sets who is allowed to adjust the – No – – No. Applies to all
only with UserCard Loudness field in the SYSTEM – Yes countries except
menu. the People's
No: The loudness can be adjusted by Republic of China.
any user. – Yes. Only applies
Yes: The loudness can only be to the People's
adjusted by users who have a Republic of China.
UserCard with additional rights.

5.2.5.1 Installing additional languages

You can use the PC Service Software to install additional optional

languages on the device. The languages are stored on the CF card in
separate language files.

Note
If you cannot install additional languages
Additional languages can only be installed if the following minimum
requirements are met:
– Software version of the device from 2.45
– Software version of PC Service Software from 2.00
 Make sure the minimum requirements are met.
 Create connection between PC Service Software and the device
with read and write authorizations (see chapter 5.5.2 on page 135).

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Note
Device cannot be used due to damaged or missing language file
If one of the following language files is damaged or missing, the device
cannot be used:
– Language file of currently selected language
– English language file
In this case, the device will display the following message in English:
The language file is missing or damaged. Please call service!
 Install missing or damaged language files again.

Installing missing or  Switch the device on.

damaged language files
 Select the SYSTEM menu.
again
 Select the SERVICE field.
Message listing corresponding language files:
The following files (total: XX files) must be updated:
 Select the Delete language files field.
 Install the corresponding language files again with the PC Service
Software.
 Select the SETUP menu.
 Select the Miscellaneous field.
 Set the required language in the Language field.

5.2.6 Network menu option

5.2.6.1 Network menu option (page 1)

SETUP menu  Network menu option

Parameter Additional information Value range or Resolution Default value

selectable options

Network settings

 Direct PC connect. Must be temporarily activated for – Passive – Passive

communication with the PC Service – Active
Software.

 Network – – Passive – Passive

– Active

TCP / IP settings

 DHCP – – Passive – Passive

– Active

 Device IP – – – 192.168.0.5

 Standard gateway – – – 192.168.0.1

 Subnet mask – – – 255.255.255.0

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5.2.6.2 Network menu option (page 2)

SETUP menu  Network menu option

Parameter Additional information Value range or Resolution Default value

selectable options

Database

 Database – – Passive – Passive

– Active

 Server address – – – 0.0.0.0

 Port – 0 to 65535 1 0

 Device type Name by which the device identifies – 5008 – 5008/6008

itself to external servers/databases – 6008
(e.g., TMON). – 5008/6008

 Check connection – – – –

DataXchange Panel
If the DataXchange Panel is to be used, the network, the database and the DataXchange Panel must be activated.

 DataXchange – – Passive – Passive

Panel – Active

 Address (see chapter 5.2.6.3 on page 104) – – –

 Check connection – – – –

5.2.6.3 Parameter Address

Under DataXchange Panel  Address, the address for the start page can be set:
(1) If no address is selected, http://10.144.47.22/dXp/default.aspx will be used as the start-up screen.
(2) If only a path is entered in the address field, this path will be preceded by the database server address and the
protocol.
(3) If the address starts with http:/, the entire address is taken from the field.

Database server address DataXchange Panel address Start-up screen

10.144.47.22 (1) http://10.144.47.22/dXp/default.aspx

10.144.47.22 (2) /malwasanderes/default.htm http://10.144.47.22/malwasanderes/default.htm

10.144.47.22 (3) http://192.168.0.1/test.htm http://192.168.0.1/test.htm

5.2.6.4 Reading the MAC address of the device

The MAC address of the device can be read by the service technician
from software version 2.46.2. The service technician needs the
corresponding rights on his ServiceCard for this purpose. With the
ServiceCard inserted, the MAC address can be read in the Status field
of the status bar.

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 Chapter 5: Setup / service program

5.2.7 BTM (option) menu option

SETUP menu  BTM menu option

Parameter Additional information Value range or Resolution Default value

selectable options

Blood line correction factor

 Correction factor – 3.000 to 15.000 0.001 6.800

5.2.8 BVM (option) menu option

SETUP menu  BVM menu option

Parameter Additional information Value range or Resolution Default value

selectable options

UF control

 Adaption mode Field on BVM SCREEN – Yes – Yes

available – No

 UF control – – Yes – Yes

possible – No

Limit. of target vol. deviation

 Positive deviation UF goal deviation 0 to 1000 ml 50 ml 500 ml

 Negative deviation UF goal deviation 0 to 1000 ml 50 ml 500 ml

 Use the BVM-Hct Field on BVM SCREEN – Available – Available

– Not available

 Blood detection Setting must only be changed by – Standard – Standard

order of the manufacturer's in writing. – sensitive
– insensitive

 RBV simulation For training purposes only – No – No

– Yes

5.2.9 Radio (option) menu option

SETUP menu  Radio menu option

Parameter Additional information Value range or Resolution Default value

selectable options

Radio receiver

 Radio channel – 0 to 165 1 0

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5.2.10 AFM (option) menu option

SETUP menu  AFM menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Measurement – – Dual – Dual measurement

mode measurement
– Single
measurement

5.2.11 Software options menu option

SETUP menu  Software options menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 LOW VOLUME – – No – No
option – Yes

 Option: automatic – – No – No
check for residual – Yes
disinfectant

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 Chapter 5: Setup / service program

SETUP menu  Software options menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 AFM option Check that the current Instructions for – No – No

Use that describe this option are – Yes
readily available at the point of
operation of the device. Ensure the
operator is given the necessary
additional instructions on any
changes made. Set the required
measurement method (see
chapter 5.2.10 on page 106).

 Sodium To enable the Sodium Management – No – No

Management function to be activated, the following – Yes
conditions must be met:
– NOVRAM variable
H1_OCM_ZPulseCorrDn is
between +9900 and +10100
– NOVRAM variable
H1_OCM_ZPulseCorrUp is
between +9900 and +10100
– NOVRAM variable
H1_OCM_CdiCdo_CalDiff is
between -50 and +50
– Conductivity difference between
CD7 and CD9 was less
than ±0.05 mS/cm according to the
last TSC report
The NOVRAM variables for the
device can be read with the PC
Service Software.
If the conditions are not met, the
following tests and calibrations must
be carried out in the order indicated
before the function is activated:
– Check the temperature with
reference meter.
– Check the conductivity with
reference meter.
– Calibrate the OCM (see
chapter 9.4.9 on page 235).
– Check whether the conditions
described above have been met.

The software options are stored in the non-volatile memory of the

monitor and are therefore retained when replacing the CF card or
updating the software version. Only if the PC board is replaced, or a
software version that does not support an existing software option is
installed (for example an older software version) might it be necessary
to reactivate the software options.

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Chapter 5: Setup / service program

5.3 USER SETUP menu

USER SETUP menu

Blood pump Parameters (see chapter 5.3.1 on page 109)

Rinse / reinfusion volume Parameters (see chapter 5.3.2 on page 109)

Anticoagulation Parameters (see chapter 5.3.3 on page 110)

Dialysate Parameters (see chapter 5.3.4 on page 112)

Ultrafiltration Parameters (see chapter 5.3.5 on page 118)

Alarm processing Parameters (see chapter 5.3.6 on page 119)

User interface Parameters (see chapter 5.3.7 on page 121)

Cleaning Parameters (see chapter 5.3.8 on page 123)

Auto On Parameters (see chapter 5.3.9 on page 124)

Emergency Parameters (see chapter 5.3.10 on page 125)

Extended safety Parameters (see chapter 5.3.11 on page 126)

ONLINE Parameters (see chapter 5.3.12 on page 126)

OCM Parameters (see chapter 5.3.13 on page 128)

Single-Needle (option) Parameters (see chapter 5.3.14 on page 129)

Miscellaneous Parameters (see chapter 5.3.15 on page 129)

BPM (option) Parameters (see chapter 5.3.16 on page 130)

BTM (option) Parameters (see chapter 5.3.17 on page 131)

BVM (option) Parameters (see chapter 5.3.18 on page 131)

SODIUM MGMT (option) Parameters (see chapter 5.3.19 on page 132)

LOW VOLUME (option) Parameters (see chapter 5.3.20 on page 132)

VenAcc (option) Parameters (see chapter 5.3.21 on page 133)

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 Selecting the USER SETUP menu

The device is switched on.

 Insert the ServiceCard.
 Select the SYSTEM menu.
In the SYSTEM menu
 Select the USER SETUP field.

 Setting the User setup menu

 Select the required function.

 Make any necessary changes.
– Save with the OK field.
– Select default values (factory settings) with the RESET field.
– With the C field, select the value previously stored.
 When using LOW VOLUME (option), observe the corresponding
description in the Instructions for Use.

5.3.1 Blood pump menu option

USER SETUP menu  Blood pump menu option

Parameter Additional information Value range or Resolution Default value

selectable options

Delivery rates

 Prime – 30 to 600 ml/min 10 ml/min 600 ml/min

with LOW VOLUME – 30 to 600 ml/min 10 ml/min 300 ml/min

 Precirculation – 30 to 600 ml/min 10 ml/min 100 ml/min

with LOW VOLUME – 30 to 600 ml/min 10 ml/min 50 ml/min

 Reinfuse – 30 to 300 ml/min 10 ml/min 100 ml/min

with LOW VOLUME – 30 to 300 ml/min 10 ml/min 50 ml/min

5.3.2 Rinse / reinfusion volume menu option

USER SETUP menu  Rinse / reinfusion volume menu option

Parameter Additional information Value range or Resolution Default value

selectable options

Preparation (NaCl)

 Rinse vol. – 500 to 5000 ml 100 ml 500 ml

with LOW VOLUME Taken over from Standard mode – – 500 ml

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USER SETUP menu  Rinse / reinfusion volume menu option

Parameter Additional information Value range or Resolution Default value

selectable options

Reinfusion (NaCl, ONL., ONL. closed circuit)

 Additional volume Reinfusion is stopped when the 0 to 100 ml 10 ml 50 ml

optical detector stops detecting blood
with LOW VOLUME and the set additional volume has 0 to 100 ml 10 ml 0 ml
also been reinfused. This reduces the
volume of blood remaining in the
cassette system.

Reinfusion (NaCl)

 Reinfusion volume – 100 to 480 ml 10 ml 250 ml

with LOW VOLUME – 100 to 250 ml 10 ml 180 ml

5.3.3 Anticoagulation menu option

USER SETUP menu  Anticoagulation menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Heparinization – – Yes – Yes

– No

with LOW VOLUME – Yes – Yes

– No

 Stop time – 0:00 to 9:59 h:min 0:01 h:min 0:30 h:min

with LOW VOLUME 0:00 to 9:59 h:min 0:01 h:min 0:30 h:min

 Syringe Depending on the setting in User – – Fresenius 30 ml

setup  Anticoagulation  Define
syringe types

with LOW VOLUME Taken over from Standard mode – – Fresenius 30 ml

Heparin rate

 Minimum rate – 0.5 to 9.9 ml/h 0.1 ml/h 0.5 ml/h

(depending on the
Heparin rate)

with LOW VOLUME 0.5 to 9.9 ml/h 0.1 ml/h 0.5 ml/h
(depending on the
Heparin rate)

 Heparin rate – 0.5 to 10.0 ml/h 0.1 ml/h 1.2 ml/h

with LOW VOLUME 0.5 to 10.0 ml/h 0.1 ml/h 1.2 ml/h

 Maximum rate – 0.6 to 10.0 ml/h 0.1 ml/h 10.0 ml/h

(depending on the
Heparin rate)

with LOW VOLUME 0.6 to 10.0 ml/h 0.1 ml/h 10.0 ml/h
(depending on the
Heparin rate)

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USER SETUP menu  Anticoagulation menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Heparin start – – Automatic – Automatic

– Manual

with LOW VOLUME – Automatic – Automatic

– Manual

Heparin bolus

 Heparin bolus – 1.0 to 20.0 ml 0.1 ml 1.0 ml

with LOW VOLUME 1.0 to 20.0 ml 0.1 ml 1.0 ml

 Maximum bolus – 1.1 to 20.0 ml 0.1 ml 20.0 ml

(depending on the
Heparin bolus)

with LOW VOLUME 1.1 to 20.0 ml 0.1 ml 20.0 ml

(depending on the
Heparin bolus)

5.3.3.1 Define syringe types menu sub-item

Warning
Risk of blood loss as a result of unsuitable heparin syringes
Using heparin syringes from third party suppliers can cause errors in the
anticoagulation medium dosage.
If any heparin syringes from third party suppliers are used, the operator
is responsible for making sure that the syringe data displayed matches
the manufacturer's information and does not lead to heparin dosage
errors.
 If heparin syringes without a Luer lock are used (not recommended),
it is the operator's responsibility to ensure that the connection
between the heparin syringe and the cassette system does not
inadvertently loosen and cause a leakage.

Only the syringes listed in Chapter 8 of the Instructions for Use are
approved for the system.
If syringes other than those listed in Chapter 8 of the Instructions for Use
are used, the responsible organization itself must ensure that the
system functions correctly.
The syringes listed in the table below, but not listed in Chapter 8 of the
Instructions for Use, have been tested only once with the system.
The manufacturer does not assume any responsibility or liability for
personal injury or other damage and excludes any warranty for damage
to the device resulting from the use of non-approved or unsuitable
consumables or accessories.

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USER SETUP menu  Anticoagulation menu option  Define syringe types menu sub-item

Parameter Additional information Value range or Resolution Default value

selectable options

Remove syringe types from the operator with the Remove syringe field. New syringe field (currently not active). Delete syringe field
(currently not active).

 Operator list – – – Fresenius 30 ml

 Syringe types – – Fresenius 20 ml – –

– Fresenius 30 ml
– B. Braun 20 ml
– B. Braun 30 ml
– B&D 20 ml
– B&D 30 ml
– Terumo 20 ml
– Terumo 30 ml

 Parameter Displays the parameters of the – – –

selected syringe.

5.3.4 Dialysate menu option

USER SETUP menu  Dialysate menu option

Parameter Additional information Value range or Resolution Default value

selectable options

Default values, dialysate

 Concentrate – Depending on the – Depending on the

setting in User setting in User
setup  Dialysate setup  Dialysate
 Define  Define
concentrates concentrates
AC-F 211.5 Can.

with LOW VOLUME Taken over from Standard mode – – –

 Prescr. Na – 128 to 151 mmol/l 1 mmol/l 138 mmol/l

(depending on the
Concentrate)

with LOW VOLUME Taken over from Standard mode – – –

 Prescr. Bic – 24.0 to 40.0 mmol/l 0.5 mmol/l 32.0 mmol/l

(depending on the
Concentrate,
maximum
±8 mmol/l)

with LOW VOLUME Taken over from Standard mode – – –

 Flow – 100 to 1000 ml/min 100 ml/min 500 ml/min

with LOW VOLUME – 100 to 1000 ml/min 100 ml/min 500 ml/min

 AutoFlow – – Yes – Yes

– No

with LOW VOLUME – – Yes – Yes

– No

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USER SETUP menu  Dialysate menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 HD factor – 1.0 to 2.0 0.1 1.5

with LOW VOLUME – 1.0 to 2.0 0.1 1.5

 HDF factor – 1.0 to 2.0 0.1 1.2

with LOW VOLUME – 1.0 to 2.0 0.1 1.2

 Temperature – 34 to 39 °C 0.5 °C 36.5 °C

with LOW VOLUME – 34 to 39 °C 0.5 °C 36.5 °C

Bags

 Empty the bibag – – Automatic – Automatic

– Manual

with LOW VOLUME Taken over from Standard mode – – –

5.3.4.1 Define concentrates menu sub-item

USER SETUP menu  Dialysate menu option  Define concentrates menu sub-item

Parameter Additional information Value range or Resolution Default value

selectable options

Remove concentrates from the Operator list with the Remove concentrate field.
Remove your own concentrates with the Delete concentrate field.
Add your own concentrates to the Concentrate list with the New concentrate field (adjustable only with ServiceCard). Set the source of the
concentrate here. Example: Concentrate container or central delivery system.
The concentrate selected under User setup  Dialysate  Default values, dialysate  Concentrate cannot be changed in its composition
nor can it be deleted.

 Operator list – – – – AC-F 211.5 Can.

– AC-F 311.25 Can.
– AC-F 311.5 Can.
– AC-F 411.25 Can.
– SmartBag 211.25
Can.
– SmartBag 211.5
Can.
– SmartBag 311.5
Can.
– SmartBagCA211.5
Can.

 Concentrate list Install additional concentrate lists – Folder: SK-F... – –

(see chapter 5.3.4.2 on page 114). – Folder: AF...
– Folder: AC-F...
– Folder:
smartbag...
– Folder: DIAMIX...
– Folder: Others...
– Additional
concentrate lists

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5.3.4.2 Installing additional concentrate lists

You can use the PC Service Software to install additional optional

concentrate lists on the device. The concentrate lists are stored on the
CF card in separate files.

Note
If you cannot install additional concentrate lists
Additional concentrate lists can only be installed if the following
minimum requirements are met:
– Software version of the device from 2.45
– Software version of PC Service Software from 2.00
 Make sure the minimum requirements are met.
 Create connection between PC Service Software and the device
with read and write authorizations (see chapter 5.5.2 on page 135).

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5.3.4.3 New concentrate menu sub-item

 Descriptions for the New concentrate menu

Name Unit Description

–
Concentrate name Concentrate name is the abbreviated name used by the manufacturer. Usually, this
includes the name of the A-concentrate.
Component proportions
A concentrate Proport. The A concentrate is the proportion of acid concentrate in the ready-to-use dialysis
fluid.
This is expressed as a reference variable for the mixing ratio, and is always 1.
B concentrate Proport. The B concentrate is the proportion of bicarbonate concentrate in the ready-to-use
dialysis fluid.
In case of acetate dialysis the value is 0.
Water Proport. Water is the dialysis water (permeate) content in the ready-to-use dialysis fluid.
Electrolytes
Na⁺ (sodium) mmol/l These are the concentrations of ions in the ready-to-use dialysis fluid.
K⁺ (potassium) mmol/l
Ca⁺⁺ (calcium) mmol/l
Mg⁺⁺ (magnesium) mmol/l
Cl⁻ (chloride) mmol/l
HCO₃⁻ (bicarbonate) mmol/l
CH₃COO⁻ (acetate) mmol/l This is the concentration of the acetate in the ready-to-use dialysis fluid originating from
the acetic acid (CH₃COOH) and, where appropriate, the sodium acetate (CH₃COONa).
Other ingredients
Glucose g/l Glucose is the concentration of glucose in the ready-to-use dialysis fluid.
Caution: The unit is g/l.
Component ingredients
Acid(A) mmol/l In case of bicarbonate dialysis:
Acid(A) is the concentration of hydrogen ions (H⁺) in one of the following acids of the A
concentrate prior to a reaction with the B concentrate (bicarbonate concentrate):
– Hydrochloric acid (HCl),
– Citric acid (C₆H₈O₇),
– Acetic acid (CH₃COOH).
When using an acid concentrate with acetic acid (CH₃COOH):
Normally acid concentrates with acetic acid (CH₃COOH) contain no sodium acetate
(CH₃COONa). So the following formula applies:
Acid(A) = CH₃COO⁻
If the acid concentrate with acetic acid (CH₃COOH) does in fact contain sodium acetate
(CH₃COONa), the following formula applies:
Acid(A) = CH₃COO⁻ – CH₃COONa
A reaction between the acetic acid (CH₃COOH) and bicarbonate (HCO₃⁻) creates
acetate (CH₃COO⁻) in the ready-to-use dialysis fluid.
In case of acetate dialysis:
When using acetate concentrates, the value is 0, because they contain no acid or
bicarbonate.
Na(B) mmol/l Na(B) is the concentration of sodium (Na) in the ready-to-use dialysis fluid which
originates from the B concentrate (bicarbonate concentrate).
The following formula generally applies:
Na(B) = HCO₃⁻ + Acid(A)
If the B concentrate (bicarbonate concentrate) also contains additional sodium chloride
(NaCl (B)), the following formula applies:
Na(B) = HCO₃⁻ + Acid(A) + NaCl (B)
The bibag and most bicarbonate concentrates do not contain any NaCl (B) however.

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 Value ranges (acetate dialysis and bicarbonate dialysis)

Designation Reso- Unit Value range - bicarbonate dialysis Value range - acetate
lution dialysis
Minimum value Maximum value Minimum Maximum
value value
–
Concentrate – – – –
name
Component proportions
A concentrate 1 Proport 1 (constant value) 1 (constant value)
.
B concentrate 1/1000 Proport (Water x 0.017) (Water x 0.055) 0
.
Water 1/1000 Proport (19.000 – B concen- 50.000 0.000 50.000
. trate), but at least 17.800!
To simplify: Calculate with this mixing ratio: (A con-
centrate + B concentrate + Water) ≥ 20
Electrolytes
Na⁺ 1 mmol/l 125 155 125 155
Requirement: Concentration of NaCl in the acid
concentrate ≥ 1800 mmol/l
K⁺ 1/100 mmol/l 0.00 5.00 0.00 5.00
Ca⁺⁺ 1/1000 mmol/l 0.000 3.000 0.000 3.000
Mg⁺⁺ 1/100 mmol/l 0.00 2.00 0.00 2.00
Cl⁻ 1/100 mmol/l 0.00 130.00 0.00 130.00
HCO₃⁻ 1/10 mmol/l 0.0 40.0 0.0 40.0
Requirement: Concentration of bicarbonate in the
bicarbonate concentrate ≥ 6 %.
CH₃COO⁻ 1/100 mmol/l 0.00 40.00 0.00 40.00
Requirement: Acetate and acid ≤ 10.00
Other ingredients
Glucose 1/100 g/l 0.00 3.00 0.00 3.00
Component ingredients
Acid(A) 1/100 mmol/l 0.00 4.00 0
Na(B) 1/10 mmol/l HCO₃⁻ + Acid(A) HCO₃⁻ + 30.0 0

Efficacy of the limit values The limit values (minimum and maximum adjustable values) of the
value ranges cannot prevent the following scenarios in every case:
– The entered recipe generates conductivity alarms
– The entered recipe creates a non-physiological dialysis fluid

Adjustable value ranges The value ranges for Prescr. Na and Prescr. Bic adjustable by the user
during a treatment during a treatment are constrained by the following limit values. The
tightest constraint in each case represents the adjustable value range
for the user (applies to acetate dialysis and bicarbonate dialysis):

Adjustable value range for Prescr. Na

Concentration of Na⁺ in the recipe: ±10 % (rounded)

125 mmol/l ≤ Prescr. Na ≤ 155 mmol/l

12.8 mS/cm ≤ expected conductivity ≤ 15.7 mS/cm

Adjustable value range for Prescr. Bic

Concentration of HCO₃⁻ in the recipe: ±8 mmol/l

20 mmol/l ≤ Prescr. Bic ≤ 40 mmol/l

12.8 mS/cm ≤ expected conductivity ≤ 15.7 mS/cm

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 Example for calculating the values to be entered (bicarbonate dialysis)

Fig.: Acid concentrate AC-F 211.75

2
3
4

12 11 10 9 8 7 6 5

Values for acid

concentrate AC-F 211.75 Designation Reso- Unit Value Item
lution
–
Concentrate – – AC-F 211.75 [1 + 44] 1
name
Component proportions
A concentrate 1 Proport 1.000 2
.
B concentrate 1/1000 Proport 1.575 4
.
Water 1/1000 Proport 42.425 3
.
Electrolytes
Na⁺ 1 mmol/l 138 12
K⁺ 1/100 mmol/l 2.00 11
Ca⁺⁺ 1/1000 mmol/l 1.750 10
Mg⁺⁺ 1/100 mmol/l 0.50 9
Cl⁻ 1/100 mmol/l 109.50 8
HCO₃⁻ 1/10 mmol/l 32.0 5
CH₃COO⁻ 1/100 mmol/l 3.00 6
Other ingredients
Glucose 1/100 g/l 1.00 7
Component ingredients
Acid(A) 1/100 mmol/l 3.00 –
(In this case CH₃COO⁻)
Na(B) 1/10 mmol/l 35.0 –
(In this case HCO₃⁻ + CH₃COO⁻)

In this example, the electrolyte content of the bicarbonate is indicated

on the concentrate container. Other manufacturers may provide this
information separately.

Entering and checking  Read off the concentrate values and convert the values to the
values correct unit as necessary.

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Chapter 5: Setup / service program

 Enter the values in the correct unit.

The sum of the cations (positively charged electrolytes) and anions
(negatively charged electrolytes) must be 0. To this end, the cations are
calculated with a plus sign and the anions with a minus sign.
Electrolytes with double charges (*) must be counted twice. Maximum
deviation of the method: 0.04 (rounding error).

Cations Anions Substance concentration Charge concentration

[mmol/l] [mEq/l]
Na⁺ – 138 + 138
K⁺ – 2.00 + 2.00
Ca⁺⁺ – 1.750 + 3.500*
Mg⁺⁺ – 0.50 + 1.00*
– Cl⁻ 109.50 – 109.50
– HCO₃⁻ 32.0 – 32.0
– CH₃COO⁻ 3.00 – 3.00
Total ± 0.000

 Check that the entered values are arithmetically correct.

Converting g/l to mmol/l Some concentrate manufacturers specify the substance concentrations
of the acid concentrate in g/l. To convert g/l to mmol/l, the atomic
weight (molar mass) of the substance must be known.
 Calculate the substance concentrate content in the ready-to-use
dialysis fluid.
Substance (1 part) [g/l] = total amount of substance [g/l]: (all parts of the mixing ratio)

 Determine the atomic weight of the substance concentration.

Atomic weight of substance [g/mol] = atomic weight of atom 1 + atomic weight of atom 2
+ ...

 Convert unit g/l to unit mmol/l.

Substance (1 part) [mol/l] = substance (1 part) [g/l]: atomic weight of substance [g/mol]
Substance (1 part) [mmol/l] = substance (1 part) [mol/l] x 1000

Detailed information will be provided by the manufacturer on request.

5.3.5 Ultrafiltration menu option

USER SETUP menu  Ultrafiltration menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 UF start Automatic: – Automatic – Automatic

when optical detector detects blood. – Manual

with LOW VOLUME Taken over from Standard mode – – Automatic

 UF with time/rate Preset rate without time – Blocked – Blocked

only – Released

with LOW VOLUME Taken over from Standard mode – – Blocked

 Max. UF rate – 100 to 4000 ml/h 10 ml/h 3000 ml/h

with LOW VOLUME – 100 to 1500 ml/h 10 ml/h 800 ml/h

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USER SETUP menu  Ultrafiltration menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Max. profile rate – 110 to 4000 ml/h 10 ml/h 3500 ml/h

with LOW VOLUME – 110 to 1510 ml/h 10 ml/h 810 ml/h

Current treatment data (displays the current treatment data during the treatment)

 Max. UF rate – – – –

 Max. profile rate – – – –

5.3.6 Alarm processing menu option

Warning
Risk for the patient as a result of ignored alarm signals
If different default alarm settings are configured for different devices, the
same alarm condition can generate a different alarm response,
depending on the device in use. This can lead to misinterpretation.
 Use the same default alarm settings for all devices.

Warning
Risk for the patient as a result of ignored alarm signals
If the volume of the audible alarm is lower than the ambient noise level,
the audible alarm output may go unnoticed.
 Use a setting for the audible alarm volume that is higher than the
ambient noise level.

USER SETUP menu  Alarm processing menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Tone Mute time – 60 to 120 sec 10 sec 120 sec

with LOW VOLUME Taken over from Standard mode – – 120 sec

 Alarmsystem The Acute and Standard alarm – Acute – Acute

systems are described in more detail – Standard
in the Instructions for Use.

with LOW VOLUME Taken over from Standard mode – – Acute

 Loudness – 1 to 9 1 6

with LOW VOLUME Taken over from Standard mode – – 6

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USER SETUP menu  Alarm processing menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Sound check – – Off – Off

– Audible alarm
– Audible warning
– Audible info
– Start-up sound

with LOW VOLUME Taken over from Standard mode – – Off

Warning times

 Flow Off – – 10 min – 10 min

– 20 min
– 30 min

with LOW VOLUME Taken over from Standard mode – – 10 min

 UF Off – 5 to 15 min 1 min 5 min

with LOW VOLUME Taken over from Standard mode – – 5 min

 Heparin Off – 1 to 5 min 1 min 1 min

with LOW VOLUME Taken over from Standard mode – – 1 min

Arterial / venous pressure settings

 Art. alarm limit Asymmetric: – Centred – Centred

Distance to lower alarm limit 1/3 of – Asymmetric
window size.
with LOW VOLUME – Centred – Centred
– Asymmetric

 Art. alarm limit – 40 to 200 mmHg 10 mmHg 100 mmHg

window size

with LOW VOLUME – 40 to 200 mmHg 10 mmHg 100 mmHg

 Ven. alarm limit During Single-Needle mode the – Asymmetric – Asymmetric

window is always set symmetrically – Centred
(centered) regardless of the Setup
setting.
with LOW VOLUME – Asymmetric – Asymmetric
Asymmetric: – Centred
Distance to lower alarm limit 1/3 of
window size.

 Ven. alarm limit – 40 to 200 mmHg 10 mmHg 100 mmHg

window size

with LOW VOLUME 40 to 200 mmHg 10 mmHg 100 mmHg

 Ven. window >= 20 mmHg: – >= 20 mmHg – >= 20 mmHg

position Lower value of the alarm limit window – Unlimited
cannot be set below 20 mmHg.

with LOW VOLUME Taken over from Standard mode – – >= 20 mmHg

 Reaction ven. Static: – Dynamic – Dynamic

window alarm reaction time 7 seconds – Static
Dynamic: – Immediately
reaction time ≤ 7 seconds (Dynamic
venous pressure monitoring)
with LOW VOLUME – Dynamic – Dynamic
– Static
– Immediately

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5.3.7 User interface menu option

USER SETUP menu  User interface menu option

Parameter Additional information Value range or Resolution Default value

selectable options

Screen saver

 Screen saver – – Yes – Yes

– No

 Delay – 0:01 to 1:00 h:min 0:01 h:min 0:05 h:min

 Additional display If "Yes" is set, the estimated Kt/V or – No – No

values the estimated Kt (if V is not available) – Yes
and the estimated substitution goal
are displayed on the screen saver.

DataXchange Panel

 Auto. close DXP – – No – No

– Yes

 Delay – 0:01 to 1:00 h:min 0:01 h:min 0:05 h:min

5.3.7.1 Graphics menu sub-item

USER SETUP menu  User interface menu option  Graphics menu sub-item

Parameter Additional information Value range or Resolution Default value

selectable options

The diagram types listed under selectable options can be assigned to a group. Each group can contain a maximum of four graphics. Each
diagram type can be contained in any group, but only once. Graphics can only be selected if the particular option is available.

 Group 1 – – UF Na diagram – – UF Na diagram

– Pressure graphs – OCM diagram
– BTM T control – Pressure graphs
– BTM rec. – BPM history
– BPM
– BPM (MAP)
– BVM
– BVM / BPM
– OCM diagram
– BPM history
– BTM events
– BVM events
– AFM
– Sodium MGMT

 Group 2 – see Group 1 – – BPM

– BPM (MAP)
– Sodium MGMT

 Group 3 – see Group 1 – –

 Group 4 – see Group 1 – –

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5.3.7.2 Define options menu sub-item

USER SETUP menu  User interface menu option  Define options menu sub-item

Parameter Additional information Value range or Resolution Default value

selectable options

Up to four option menu buttons can be selected to appear on-screen. The added options will appear at the lower right, above the SYSTEM
field. (If the BPM option is available, a maximum of three options can be set up.) Options can be added only if the particular option is available.

 Option – – HEPARIN – – HEPARIN

– CIRCU LATION – ONLINE
– SINGLE-
NEEDLE
– ONLINE
– OCM
– BPM
– BVM
– BTM
– Sodium MGMT
– AFM

5.3.7.3 Define controls menu sub-item

USER SETUP menu  User interface menu option  Define controls menu sub-item

Parameter Additional information Value range or Resolution Default value

selectable options

The TREATMENT menu displays six fields in one row by default. In addition, two further rows with a maximum of 12 fields can be set up,
depending on the field size. Option fields can be added only if the particular option is available.

 From the – – Concentrate – –

DIALYSATE MENU – Na profile
– Temperature
– Flow
– AutoFlow

 From the UF MENU – UF profile – –

 From HEPARIN – – Heparin rate – –

menu – Stop time
– Heparin bolus
– Cum. vol.
– Heparin
bolus I/O

 From ONLINE menu – – Treatment mode – –

– AutoSub plus I/O
– (Estimated) sub
goal
– Subrate
– Sub pump I/O
– Hct

 From SODIUM – – Overall Na – –

MGMT menu balance
– Diffusive Na
balance

 From SINGLE- – – Effective blood – –

NEEDLE menu flow
– Stroke vol.
– Ratio (approx.)

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USER SETUP menu  User interface menu option  Define controls menu sub-item

Parameter Additional information Value range or Resolution Default value

selectable options

 From LOW – – LOW VOLUME – –

VOLUME menu I/O
– Dry weight

 From BTM menu – – Recirculation I/O – –

– Recirculation
– Temperature
change
– BTM

 From BVM menu – – Crit. RBV – –

– RBV
– Min. RBV
– Hct BVM
– Hb
– BVM
– Food intake

5.3.8 Cleaning menu option

USER SETUP menu  Cleaning menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Automatic – – Yes – Yes

cleaning after – No
treatment

 Audible info – – No – No
– Yes

 Auto Off – – 10 min – 10 min

– Immediately
– 30 min
– 60 min
– No

 Disinfection note – – Yes – Yes

– No

 Check for residual Only if "Automatic check for residual – Automatic – Automatic
disinfectant disinfectant" option is available – Manual

 Hint: check for – – Yes – Yes

residual – No
disinfectant

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5.3.9 Auto On menu option

Tip
A bibag can be connected following completion of the last device
disinfection of the day (72 hours is the maximum time allowed prior to
treatment). To use this possibility, note the following points.

Requirements – Pre-program the T1 test under Auto On (observe the time

programming of the osmosis unit)
– CDS for acid connected

Warning
Risk of contamination as a result of non-compliance with hygienic
conditions
Microbial contamination can occur during the connection of the bibag.
 After removing the foil, immediately connect the bibag using aseptic
technique. Then close the bibag flap.

If a cleaning program or the T1 test is started automatically, no audible

alarm will be sounded during the cleaning program or the T1 test.

USER SETUP menu  Auto On menu option

Parameter Additional information Value range or Resolution Default value

selectable options

Weekly programs
The program and the power-up time can be preselected. Then switch programming on or off via Status. If several programming actions have
been performed, it is possible to switch them all on or off via the Auto On programs I/O field.

Programs + power-up time

 Programs Cleaning programs: – No program – No program

+ Shows the cleaning programs – Cleaning
selected in the Service setup. programs
Programmable cleaning programs: – Standby
– Rinse – T1 test
– Cold disinfection
– Heat disinfection
– Degreasing / cold disinfection
– Integrated hot rinse + cool down
rinse
– Integrated hot rinse
– Interface heat disinfection

 Power-up time – 00:00 to 24:00 1 min 00:00

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USER SETUP menu  Auto On menu option

Parameter Additional information Value range or Resolution Default value

selectable options

Single programs
The program and the power-up time can be preselected. Then switch programming on or off via Status. If several programming actions have
been performed, it is possible to switch them all on or off via the Auto On programs I/O field.

Programs + power-up time

 Programs Cleaning programs: – No program – No program

+ Shows the cleaning programs – Cleaning
selected in the Service setup. programs
Programmable cleaning programs: – Standby
– Rinse – T1 test
– Cold disinfection
– Heat disinfection
– Degreasing / cold disinfection
– Integrated hot rinse + cool down
rinse
– Integrated hot rinse
– Interface heat disinfection

 Power-up time – 00:00 to 24:00 1 min 00:00

5.3.10 Emergency menu option (reaction after selecting the Emergency field)

USER SETUP menu  Emergency menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 UF Off – – Yes – Yes

– No

with LOW VOLUME – Yes – Yes

– No

 Reduced blood ONLINE bolus = No: – – 50 ml/min

flow rate reduction to Reinfuse delivery rate

with LOW VOLUME Taken over from Standard mode – – 50 ml/min

 Blood pressure – – No – No
measurement – Yes

with LOW VOLUME – No – No

– Yes

 ONLINE bolus Activates the following ONLINE – Yes – Yes

parameters if set. – No

with LOW VOLUME Taken over from Standard mode – – Yes

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USER SETUP menu  Emergency menu option

Parameter Additional information Value range or Resolution Default value

selectable options

ONLINE parameters

 Bolus ONLINE bolus = No: – – –

– ----
ONLINE bolus = Yes:
– see ONLINE menu option

 Bolusrate ONLINE bolus = No: – – –

– ----
ONLINE bolus = Yes:
– see ONLINE menu option

 Bolusrate ONLINE bolus = No: – – –

– ----
ONLINE bolus = Yes:
– see ONLINE menu option

5.3.11 Extended safety menu option

USER SETUP menu  Extended safety menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Pressure holding – – Yes – Yes

test, dialyzer – No
couplings

 Kinking (BLK) Kinking/clotting – Yes – Yes

– No

5.3.12 ONLINE menu option

USER SETUP menu  ONLINE menu option

Parameter Additional information Value range or Resolution Default value

selectable options

ONLINE / NaCl

 ONLINE / NaCl The relevant tabs are displayed in the – ONLINE – ONLINE
Blood system menu depending on the – ONLINE + NaCl
setting. – NaCl

with LOW VOLUME Taken over from Standard mode – – ONLINE

Preparation (ONLINE)

 ONL rinse vol – 500 to 5000 ml 100 ml 500 ml

with LOW VOLUME Taken over from Standard mode – – 500 ml

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USER SETUP menu  ONLINE menu option

Parameter Additional information Value range or Resolution Default value

selectable options

Treatment mode

 Treatment mode – – HDF postdilution – HDF postdilution

– HD
– HDF predilution
– HF predilution
– HF postdilution

with LOW VOLUME – HDF postdilution – HDF postdilution

– HD
– HDF predilution
– HF predilution
– HF postdilution

Substitution

 Substitution – – Automatic – Automatic

– Manual

with LOW VOLUME – Automatic – Automatic

– Manual

Bolus

 Bolus – 30 to 240 ml 30 ml 150 ml

with LOW VOLUME – 30 to 240 ml 30 ml 30 ml

 Bolusrate Presetting – Automatic – Automatic

– Manual

with LOW VOLUME – Automatic – Automatic

– Manual

 Bolusrate Bolusrate = Manual 100 to 250 ml/min 10 ml/min 200 ml/min

Bolusrate = Automatic
Bolusrate = blood flow rate –
50 ml/min (see chapter 4.16 on
page 82)

with LOW VOLUME – 30 to 250 ml/min 10 ml/min 100 ml/min

Hemoconcentration

 Monitoring – – Yes – Yes

– No

with LOW VOLUME – Yes – Yes

– No

 Dialyzer Depends on the currently available e.g.: – FX CorDiax 600

dialyzers – FX CorDiax 40
– FX CorDiax 600
– ...

with LOW VOLUME – e.g.: – FX CorDiax 40

– FX CorDiax 40
– ...

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USER SETUP menu  ONLINE menu option

Parameter Additional information Value range or Resolution Default value

selectable options

Reinfusion (ONLINE)

 ONLINE reinfusion – – ONLINE – ONLINE

procedure – ONLINE closed
circuit

with LOW VOLUME – ONLINE – ONLINE

– ONLINE closed
circuit

 Reinfusion volume – 210 to 480 ml 30 ml 390 ml

with LOW VOLUME – 30 to 300 ml 30 ml 180 ml

5.3.12.1 Define dialyzers menu sub-item

USER SETUP menu  ONLINE menu option  Define dialyzers menu sub-item

Parameter Additional information Value range or Resolution Default value

selectable options

 Operator list Dialyzers taken from the Dialyzer list e.g.: – FX CorDiax 600
– FX CorDiax 40
– FX CorDiax 600
– FX CorDiax 1000
– ...

 Dialyzer list Depends on the currently available e.g.: – –

dialyzers – FX CorDiax 40
– FX CorDiax 600
– FX CorDiax 1000
– ...

Remove dialyzers from the operator list with the Remove dialyzer field.

Define new dialyzers and add them to the dialyzer list with the New dialyzer field. Newly created dialyzers are identified with an asterisk (*)
preceding the dialyzer name.

 Dialyzer name – – – –

Rename a dialyzer you created yourself with the Modify dialyzer field.

Delete dialyzers from the dialyzer list with the Delete dialyzer field. (The default value cannot be deleted.)

5.3.13 OCM menu option

USER SETUP menu  OCM menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 OCM start – – Automatic – Automatic

– Manual

with LOW VOLUME Taken over from Standard mode – – Manual

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USER SETUP menu  OCM menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Kt/V warning – – Yes – Yes

– No

with LOW VOLUME Taken over from Standard mode – – Yes

 Use BCM data – – Yes – Yes

– No

with LOW VOLUME Taken over from Standard mode – – Yes

Current treatment data (not saved in Setup)

 Interval Time between two measuring cycles 0:25 to 2:00 h:min 0:01 h:min 0:25 h:min

with LOW VOLUME Taken over from Standard mode – – 0:25 h:min

5.3.14 Single-Needle (option) menu option

USER SETUP menu  Single-Needle menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Stroke vol. – 10 to 60 ml 5 ml 35 ml

 Rate ratio Ratio of blood delivery rates in the –60 to +60 % 5% +20 %
venous and arterial phases

5.3.15 Miscellaneous menu option

USER SETUP menu  Miscellaneous menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Installation place Shown in Status  Device info. – – Installation location

of the device (e.g.,
name of the
hospital).

Water supply

 Reverse osmosis Single station unit – ---- – ----

unit – AquaUNO /
AquaC UNO H

 Valve, venous – – Controlled – Controlled

insertion site – Always open

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5.3.16 BPM (option) menu option

USER SETUP menu  BPM menu option

Parameter Additional information Value range or Resolution Default value

selectable options
*

 SYS max – 95 to 250 mmHg 1 mmHg 165 mmHg

with LOW VOLUME Taken over from Standard mode – – 165 mmHg

 DIA max – 65 to 200 mmHg 1 mmHg 100 mmHg

with LOW VOLUME Taken over from Standard mode – – 100 mmHg

 MAP max – 75 to 235 mmHg 1 mmHg 120 mmHg

with LOW VOLUME Taken over from Standard mode – – 120 mmHg

 PULSE max – 50 to 200 1/min 1 1/min 150 1/min

with LOW VOLUME Taken over from Standard mode – – 150 1/min

 SYS min – 60 to 230 mmHg 1 mmHg 90 mmHg

with LOW VOLUME Taken over from Standard mode – – 90 mmHg

 DIA min – 40 to 190 mmHg 1 mmHg 50 mmHg

with LOW VOLUME Taken over from Standard mode – – 50 mmHg

 MAP min – 45 to 215 mmHg 1 mmHg 70 mmHg

with LOW VOLUME Taken over from Standard mode – – 70 mmHg

 PULSE min – 40 to 175 1/min 1 1/min 40 1/min

with LOW VOLUME Taken over from Standard mode – – 40 1/min

 Preselected Depends on equipment variant. – Automatic – – – Automatic

pressure – 100 to 290 mmHg – 1 mmHg – 160 mmHg

with LOW VOLUME – – Automatic – – – Automatic

– 100 to 290 mmHg – 1 mmHg – 140 mmHg

Additional interval measurement

 Before treatment Availability depends on configuration. – Off 5 min 5 min

end – 5 to 30 min

with LOW VOLUME Taken over from Standard mode – – 5 min

 After reinfusion Availability depends on configuration. – On – On

– Off

with LOW VOLUME Taken over from Standard mode – – On

(* = Value ranges can vary depending on equipment variant.)

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5.3.17 BTM (option) menu option

USER SETUP menu  BTM menu option

Parameter Additional information Value range or Resolution Default value

selectable options

BTM

 BTM Line detection after switching power – Active – Active

on – Passive

with LOW VOLUME Taken over from Standard mode – – Active

Recirculation

 Recirculation Can only be selected if Temp. – Automatic – Automatic

measurement control: Manual – Manual

with LOW VOLUME – – Automatic – Automatic

– Manual

Body temperature

 Temp. control – – Manual – Manual

– Automatic

with LOW VOLUME Taken over from Standard mode – – Manual

 Change rate – –0.5 to +0.5 °C/h 0.1 °C/h 0.0 °C/h

with LOW VOLUME Taken over from Standard mode – – 0.0 °C/h

 Max. dialysate – 37.0 to 38.0 °C 0.5 °C 37.5 °C

temperature

with LOW VOLUME Taken over from Standard mode – – 37.5 °C

Room temperature

 Room temperature Not measured, has to be set. 15.0 to 35.0 °C 1.0 °C 20.0 °C

with LOW VOLUME Taken over from Standard mode – – 20.0 °C

5.3.18 BVM (option) menu option

USER SETUP menu  BVM menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 BVM BVM cuvette detection method after – Passive – Passive

switching on – Active

with LOW VOLUME Taken over from Standard mode – – Passive

 Max. BVM rate – 50 to 2800 ml/h 50 ml/h 2800 ml/h

with LOW VOLUME – 50 to 1500 ml/h 50 ml/h 800 ml/h

 Hemoglobin unit – – g/dl – g/dl

– mmol/l

with LOW VOLUME Taken over from Standard mode – – g/dl

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USER SETUP menu  BVM menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Use the BVM-Hct Setting the field in the BVM menu – Yes – Yes
– No

with LOW VOLUME Taken over from Standard mode – – Yes

Initial target volume deviation

 Positive deviation Limited to the value set in the Service 0 to 500 ml* 50 ml 0 ml
setup – *the upper limit of 500 ml can
be changed by the technician at the
physician's responsibility

with LOW VOLUME Taken over from Standard mode – – 0 ml

 Negative deviation Limited to the value set in the Service 0 to 500 ml* 50 ml 0 ml
setup – *the upper limit of 500 ml can
be changed by the technician at the
physician's responsibility

with LOW VOLUME Taken over from Standard mode – – 0 ml

 Food intake – – Yes – Yes

– No

with LOW VOLUME Taken over from Standard mode – – Yes

5.3.19 SODIUM MGMT (option) menu option

USER SETUP menu  SODIUM MGMT menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 Na balance [unit] – – g NaCl – g NaCl

– g Na
– mmol Na
– mval Na
– mEq Na

5.3.20 LOW VOLUME (option) menu option

USER SETUP menu  LOW VOLUME menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 LOW VOLUME – – Blocked – Blocked

– Released

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5.3.21 VenAcc (option) menu option

User setup menu  VenAcc menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 VenAcc option – – Off – Off

– On

 Automatic login – – Off – Off

– On

5.4 APPLICATIONS menu

APPLICATIONS menu

Training Parameters (see chapter 5.4.2 on page 134)

PatientCard Parameters (see chapter 5.4.1 on page 134)

 Selecting the APPLICATIONS menu

The device is switched on.

 Insert the ServiceCard.
 Select the SYSTEM menu.
In the SYSTEM menu
 Select the APPLICATIONS field.

 Setting the APPLICATIONS menu

In the APPLICATIONS menu

 Select the required function.
 Make any necessary changes.

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5.4.1 PatientCard menu option

APPLICATIONS menu  PatientCard menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 First name – – – –

 Surname – – – –

 Database ID Only required if the device is in a – – –

network with the TDMS

 Date of birth – – – –

Creating the PatientCard:  Insert the PatientCard.

 Enter the required data for the patient.
(After pressing the required field, enter the data using the keyboard.)
 Confirm the entered patient data with the OK field.
Visually check the confirmed patient data.
 Select the Create PatientCard field.
Message: Saving data to PatientCard. Leave PatientCard inserted!
 Once the message has disappeared, remove the PatientCard.

5.4.2 Training menu option

 Select the Training field to go to the Training menu (for training

purposes only).

APPLICATIONS menu  Training menu option

Parameter Additional information Value range or Resolution Default value

selectable options

 OD simulation OD simulation is disabled (blocked) – Blocked – Blocked

again if – Released
– The device is switched off and back
on again
– The optical detector has detected
blood

 Screenshots – – Blocked – Blocked

– Released

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5.5 PC Service Software service program

5.5.1 Matrix of the software versions of the PC Service Software

There is a service program called PC Service

Software for the device. The PC Service
Software can be used if the specified
software version of the PC Service Software
has been installed on a computer.

Software version of the Software version of the PC Service Software

6008 device
from 2.10 from 1.71 to 1.64

from 2.46 Yes No No

from 2.44.0 Yes Yes No

to 2.43.1 Yes Yes Yes

5.5.2 Connection methods of the PC Service Software

Two possible connection From software version 2.46 the device differentiates during the initial
methods connection to the PC Service Software between two possible
connection methods:
– Connection with ServiceCard inserted in the device
– Connection with ServiceCard inserted in the card reader of the
computer

Connection method 1 Connection with ServiceCard inserted in the device

If a valid ServiceCard with appropriate rights is inserted into the device
during the initial connection, then a connection with read and write
authorizations is established.
 Insert the ServiceCard into the device.

Note
No access rights due to invalid ServiceCard
After successfully completing the appropriate training for the 6008
device, an expiry date is explicitly set for this device on the ServiceCard.
When the expiry date of the ServiceCard has been exceeded, the
following message is issued when the ServiceCard is inserted: Card not
valid, as expiry date has been exceeded. – OK
 When the expiry date has been exceeded, select the OK field and
have the expiry date of the ServiceCard extended.

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 Establish connection with the PC Service Software in accordance

with the Instructions for Use.

Connection method 2 Connection with ServiceCard inserted in the card reader of the
computer
If a valid ServiceCard with appropriate rights is inserted in the card
reader of the computer during the initial connection, then a connection
with read authorizations is established. The time and the operating
hours can also be changed.
 Insert the ServiceCard into the card reader of the computer.

Note
No access rights due to invalid ServiceCard
After successfully completing the appropriate training for the 6008
device, an expiry date is explicitly set for this device on the ServiceCard.
When the expiry date of the ServiceCard has been exceeded, the
following message is issued when the ServiceCard is inserted: Card not
valid, as expiry date has been exceeded. – OK
 When the expiry date has been exceeded, select the OK field and
have the expiry date of the ServiceCard extended.

 Establish connection with the PC Service Software in accordance

with the Instructions for Use.

5.5.3 Quick Reference Guide for the PC Service Software

5.5.3.1 Opening the Quick Reference Guide with the PC Service Software

Requirement The PC Service Software has been installed.

 Start the PC Service Software.
 In the ? (Help) menu, click the Help Topics field.

5.5.3.2 Opening the Quick Reference Guide from the installation CD

You can read the Quick Reference Guide from the installation CD
without installing the PC Service Software.
 Insert the installation CD for the PC Service Software into the
computer’s CD drive.
 Start Windows Explorer.
 Open the Documentation directory (3) on the installations CD.
The Quick Reference Guide is filed in the Documentation directory (3).
 Open the appropriate file.

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6 Technical safety checks / maintenance

procedures

6.1 Important information on TSCs/MAs

Considerations for Read the information under "Considerations for working on the device"
working on the device (see chapter 2.5 on page 19).

Technical safety checks The first TSCs are required before the end of the 24th month following
(TSC) initial start-up after delivery from the factory. All further TSCs are
required before the end of the 24th month following the last TSC
performed.
The technical measurement checks (TMCs) additionally required are
country-specific and form part of the technical safety checks (TSCs).
The completion of the TSCs must be recorded in the Medical Device
Register.

Maintenance procedures The maintenance procedures (MA) are a recommendation of the

(MAs) manufacturer. The maintenance procedures help ensure trouble-free
operation, and must be carried out for the first time before the end of the
24th month following initial start-up after delivery from the factory. All
further maintenance procedures should be performed before the end of
the 24th month following the last maintenance procedure performed.

Qualification requirements The checks must be performed by the manufacturer's service support
of testers organization or a person authorized by it.
The checks must be performed by personnel qualified to perform them
correctly, based on their education, training, knowledge and
experience. Furthermore, the persons performing the checks must be
permitted to do so independently and without outside interference.

Processing the report The report consists of inspection items and the corresponding
explanatory notes. The inspection items and the corresponding
explanations are related to each other and should be processed in
chronological order.

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6.2 Accessories required for the TSCs/MAs

Item Position Description

TSC and maintenance kit 5008S/6008 and For TSC and device maintenance.
maintenance kit 6008

Long tube adapter For checking the pressure display

and the venous occlusion clamp.

Short tube adapter For checking the venous occlusion

clamp.

UNISILKON L 250 L grease Use only in places described in the

explanations.

BARRIERTA L55/1 grease Port seals Use only in places described in the
explanations.

Lithium battery CR 2032 (3 V/230 mAh) PC board in monitor Interval: Replace every four years.

Lithium battery CR 2032 (3 V/230 mAh) PCB LP 1186 in power Interval: Replace every ten years.
supply unit with serial
number section WMT

Lithium battery CR 1225 (3 V/42 mAh) PCB LP 1105-1 in Interval: Replace every four years.
power supply unit with
serial number section
VMA

Lead-acid battery power pack (24 V/7.2 Ah) Base rear Interval: Replace every four years.

Label set Replace labels only if required.

Disinfectant valve V20 V20 Use disinfectant valve suitable for

disinfectant. The disinfectant valve
has a yellow identification label.
Only applicable when using
Puristeril 340, Puristeril plus:
replace V20

Disinfectant valve V34 V34 Use disinfectant valve suitable for

disinfectant. The disinfectant valve
has a yellow identification label.
Only when using Sporotal 100 and
suction via disinfectant connector
H35:
replace V34

Blood pump drive EBM Interval: Replace every 36,000

operating hours.

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Item Position Description

Substituate pump drive EBM Interval: Replace every 36,000

operating hours.

Filter F07 and O-ring F07 Hydraulics Only if the filter F07 is connected.

Filter insert External dialysate filter Only if the external dialysate filter is
in the dialysate outlet in the dialysate outlet port (left).
port (left)

6.3 TSC/MA report

TSC/MA report TSC report The TSC/MA report (see TSC/MA report on page 140) and the TSC
report (see TSC report on page 207) differ in the following points:
– Maintenance procedures (MAs)
– Category TSC or MA in first column

Explanatory notes for The explanatory notes for completing the report are in a separate
completing the report chapter (see chapter 6.4 on page 144).

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TSC/MA report 6008

Customer number/customer name: Inventory number:
Tester's name: Operating hours:
Software version: Equipment code:
Service report number: Serial number:
Cat. No. Designation Operating Measured /NA
state value/correction
Information:  = successful inspection item. NA = non-applicable inspection item.
1 Checks/procedures with device switched off and power plug unplugged
TSC 1.1 Power supply cord checked for signs of damage. Off – 
TSC 1.2 Checked that the fuse accessible on the outside has the correct rating. If Off – 
present, checked seal for damage.
TSC 1.3 Checked that all labels and inscriptions are present and legible. Off – 
TSC 1.4 Device checked for damage and dirt. Off – 
Target value: The mechanical condition of the device allows further safe use as
intended.
TSC 1.5 Hand crank for manual reinfusion present on device rear. Off – 
2 Check, clean, change components
MA 2.1 Fan filter on the rear of the device replaced. Off –  /
MA 2.2 O-rings in dialyzer couplings greased and replaced. Off –  /
MA 2.3 O-rings on bibag connector greased and replaced. Off –  /
MA 2.4 Interval: Replace every four years. Off –  /
Molded seal of the substituate unit greased and replaced. The molded seal is
dark gray. O-ring in the substituate unit replaced. The O-ring is transparent.
TSC 2.5 Rinse port lip seal greased and replaced. Off – 
MA 2.6 Arterial and venous occlusion clamps checked. Off –  /
TSC 2.7 Rotors dismantled and cleaned. Off – 
TSC 2.8 Hydrophobic filter F42 with O-ring replaced. Off – 
Air feeding unit checked for fluid ingress.
MA 2.9 Hydrophobic filter F_NBC_3 replaced. Off –  /
TSC 2.10 Screws on blood and substituate pump drives tightened (230 Ncm). Off – 
MA 2.11 Blood and substituate pump drives replaced according to interval. Off –
Replace every 36,000 operating hours: Blood pump drive.  /
Replace every 36,000 operating hours: Substituate pump drive.  /
TSC 2.12 Cassette contact mat and frame replaced. Off – 
MA 2.13 O-rings and port seals of the cassette coupling port/cassette deaeration port Off – 
greased and replaced.
TSC 2.14 Interval: Replace every six years. Off – 
Tubing in substituate valve (V31) replaced. New tube shortened to 70 mm in
total. Tube clip fitted according to angled nozzle used.
TSC 2.15 Filter F06 replaced. Off – 
TSC 2.16 Leakage sensors (EBM, S35) inspected visually. Leakage sensors cleaned. Off – 
MA 2.17 Filters F11 acid suction tube and F12 bicarbonate suction tube checked for Off –  /
damage.
New greased seals inserted in the acid suction tube and bicarbonate suction
tube.
TSC 2.18 Check valve for water inlet (A05) checked for proper function. Off – 
MA 2.19 Filters F01, F08, F14, F15, F17 and F18 replaced. Off –  /
O-rings F01, F14 and F15 greased and replaced.
MA 2.20 Only if the filter F07 is connected: Off –  /
Filter F07 replaced. O-ring F07 greased and replaced.
MA 2.21 Only if the external dialysate filter is in the dialysate outlet port (left): Off –  /
Filter insert replaced.
MA 2.22 Dirty or unsightly tubes replaced. Off –  /
MA 2.23 Filters F10 and F16 disinfectant container checked for damage. Off –  /
O-rings H20 and H35 greased and replaced.
MA 2.24 Only applicable when using Puristeril 340, Puristeril plus: Off –  /
Disinfectant valve V20 replaced. The disinfectant valve has a yellow
identification label.
MA 2.25 Only when using Sporotal 100 and suction via disinfectant connector H35: Off –  /
Disinfectant valve V34 replaced. The disinfectant valve has a yellow
identification label.
MA 2.26 Interval: Replace every four years. Off –  /
Rechargeable battery for device replaced.
MA 2.27 Interval: Replace every four years. Off –  /
Battery on PC board replaced.
MA 2.28 Interval: Replace every four years. Off –  /
Battery of power supply unit with PCB LP 1105-1 (VMA) replaced.

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Service report number: Serial number:

Cat. No. Designation Operating Measured /NA
state value/correction
MA 2.29 Interval: Replace every ten years. Off –  /
Battery of power supply unit with PCB LP 1186 (WMT) replaced.
3 Hydraulics
Information: Connect the power plug and switch the device on.
MA 3.1 Only for software version ≤ 2.44 or SETUP  Settings Hydraulics  Auto Service, –  /
calibration  Degassing (P01) = No: CALIBRATE
Degassing pump calibrated.
MA 3.2 Loading pressure of balancing chamber checked. Service, / mbar  /
Target value: 1800 mbar to 1900 mbar CALIBRATE
MA 3.3 Flow pump calibrated. Service, –  /
CALIBRATE
MA 3.4 Maximum water inflow when the reverse osmosis unit is running under its Service, / ml/min  /
normal load checked. CALIBRATE
Target value: 1300 ml/min to 1550 ml/min (the target value may, under a
specific condition, be 1300 ml/min to 1800 ml/min as described in the
explanatory notes).
MA 3.5 Only if concentrate containers are used exclusively: Service, –  /
Level sensor (S17) checked. CALIBRATE
MA 3.6 Only if bicarbonate containers are used exclusively: Service, –  /
Level sensor (S19) checked. CALIBRATE
MA 3.7 Only if CDS (option) used exclusively: Service, –  /
Function of suction tube flap checked. CALIBRATE
4 Dialysate pressure
MA 4.1 Zero point S03/S07 checked. Service,  /
Reference meter: +0 mbar (±5 mbar) CALIBRATE / mbar
Check S03. / mbar
Target value: S03 = Display of reference meter + (+11 mbar to +71 mbar)
Check S07. / mbar
Target value: S07 = Display of reference meter + (+11 mbar to +71 mbar)
MA 4.2 Slope S03/S07 (+) checked. Service,  /
Reference meter: +533 mbar (±26 mbar) CALIBRATE / mbar
Check S03. / mbar
Target value: S03 = Display of reference meter + (+11 mbar to +71 mbar)
Check S07. / mbar
Target value: S07 = Display of reference meter + (+11 mbar to +71 mbar)
MA 4.3 Slope S03/S07 (–) checked. Service,  /
Reference meter: –533 mbar (±26 mbar) CALIBRATE / mbar
Check S03. / mbar
Target value: S03 = Display of reference meter + (+11 mbar to +71 mbar)
Check S07. / mbar
Target value: S07 = Display of reference meter + (+11 mbar to +71 mbar)
5 Blood leak detector
TSC 5.1 Blood leak detector checked. Service, 
Target value for blood leak voltage: 4.8 Volt to 5.2 Volt CALIBRATE / Volt
Target value for dimness voltage: 4.7 Volt to 5.3 Volt / Volt
6 Temperature/conductivity
Information: Device set up for verifying temperature and conductivity.
– Close the shunt interlock – no bypass
– Dialysate flow: 500 ml/min
– Dialysate temperature: 36.8 °C to 37.2 °C
– Conductivity: 13.5 mS/cm to 14.5 mS/cm
TSC 6.1 Temperature tested with reference meter. Service, 
Display of temperature sensor PT7 CALIBRATE / °C
Display of reference meter / °C
Target value for temperature difference (reference meter – PT7): –0.5 °C to / °C
+0.2 °C
TSC 6.2 Conductivity tested with reference meter. If a bibag is generally used, the test Service, 
must be performed with a bibag. CALIBRATE
Display of conductivity sensor CD7 / mS/cm
Display of reference meter / mS/cm
Target value for conductivity difference (reference meter – CD7): ±0.15 mS/cm / mS/cm
7 OCM
TSC 7.1 Conductivity difference between CD7 and CD9 checked. Service, 
Target value for conductivity difference (CD7 – CD9): ±0.05 mS/cm CALIBRATE / mS/cm
If the conductivity difference is > ±0.05 mS/cm: Calibrate conductivity and OCM.
8 Extracorporeal components
TSC 8.1 Cassette sensors calibrated. Service, – 
CALIBRATE

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Service report number: Serial number:

Cat. No. Designation Operating Measured /NA
state value/correction
TSC 8.2 Function of substituate unit checked. Service, – 
DIAGNOSTI
CS
TSC 8.3 Function of Blood System Stop button checked. Service, – 
DIAGNOSTI
CS
MA 8.4 Pneumatics test performed. Service, –  /
DIAGNOSTI
CS
MA 8.5 Single-Needle pneumatics test (option) performed. Service, –  /
DIAGNOSTI
CS
9 Options
9.1 BPM (option): The technical measurement checks (TMCs) additionally required are country-specific and form part of  /
the technical safety checks (TSCs).
MA 9.1.1 Blood pressure cuff and pressure tubing are correctly connected to the BPM Service –  /
(option).
MA 9.1.2 Blood pressure cuff and pressure tubing checked for damage. Damaged parts Service –  /
replaced.
TSC 9.1.3 BPM (option) checked for leaks. Service, / mmHg/ 
TMC Target value Maximum leakage rate: ≤ 6 mmHg/min DIAGNOSTI min
CS
TSC 9.1.4 BPM (option) checked against the required pressures. Service, 
TMC Reference meter: +250 mmHg (±3 mmHg) DIAGNOSTI / mmHg
CS
Target value for BPM: Display of reference meter (±3 mmHg) / mmHg
Reference meter: +200 mmHg (±3 mmHg) / mmHg
Target value for BPM: Display of reference meter (±3 mmHg) / mmHg
Reference meter: +150 mmHg (±3 mmHg) / mmHg
Target value for BPM: Display of reference meter (±3 mmHg) / mmHg
Reference meter: +100 mmHg (±3 mmHg) / mmHg
Target value for BPM: Display of reference meter (±3 mmHg) / mmHg
Reference meter: +50 mmHg (±3 mmHg) / mmHg
Target value for BPM: Display of reference meter (±3 mmHg) / mmHg
TSC 9.1.5 Safety valve of BPM (option) checked. Standby – 
TMC Target value: The cuff deflates when the safety valve is opened.
TSC 9.1.6 Blood pressure measurement performed with the BPM (option). Standby – 
TMC Target value: The measured values are plausible.
9.2 BTM (option): There are no additional technical safety checks and maintenance procedures to be performed (exception:
measurement of the protective earth resistance).
9.3 BVM (option): There are no additional technical safety checks and maintenance procedures to be performed (exception:
measurement of the protective earth resistance).
10 Error memory
MA 10.1 Save and erase error memory. Service, –  /
CALIBRATE
11 Electrical safety check according to (DIN) EN 62353:2015, IEC 62353:2014, and functional test
Information: Switch off the device.
TSC 11.1 Protective earth resistance measured and checked. Off / Ω 
Target value: ≤ 0.3 Ω with power supply cord
Information: Switch the device on. Prepare and fill in service report and documents.
TSC 11.2 T1 test completed successfully. T1 test – 
11.3 Pressure displays
TSC 11.3.1 Zero point of arterial pressure display checked. T1 test, EBM / mmHg 
Target value: 0 mmHg ±5 mmHg Flow
Diagram
TSC 11.3.2 Zero point of venous pressure display checked. T1 test, EBM / mmHg 
Target value: 0 mmHg ±5 mmHg Flow
Diagram
TSC 11.3.3 Zero point of pre-filter pressure display checked. T1 test, EBM / mmHg 
Target value: 0 mmHg ±5 mmHg Flow
Diagram
TSC 11.3.4 Check the slope of the arterial pressure display with a built-up pressure of T1 test, EBM / mmHg 
approximately 280 mmHg. Flow
Target value: built-up pressure ±10 mmHg Diagram
TSC 11.3.5 Check the slope of the venous pressure display with a built-up pressure of T1 test, EBM / mmHg 
approximately 280 mmHg. Flow
Target value: built-up pressure ±10 mmHg Diagram
TSC 11.3.6 Slope of the pre-filter pressure display checked with a built-up pressure of T1 test, EBM / mmHg 
approx. 280 mmHg. Flow
Target value: built-up pressure ±15 mmHg Diagram

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Service report number: Serial number:

Cat. No. Designation Operating Measured /NA
state value/correction
TSC 11.3.7 Venous occlusion clamp checked. T1 test, EBM / mmHg 
A change in pressure must not exceed the following values within 3 minutes: Flow
Arterial pressure display, maximum change in pressure: ±5 mmHg Diagram
Pressure display of reference meter, maximum pressure drop: –75 mmHg
TSC 11.4 Applied part type: type B Preparation 
Device leakage currents of applied part type B measured, measurement value
scaled to nominal line voltage and checked against "Additional condition".
Target value: IN ≤ 500 μA
 Differential current measurement according to figure 8
 Direct measurement according to figure 7
Nominal voltage of the power supply (U0) V
AC polarity L – N:
Maximum device leakage current (IBmax) / μA
Actual line voltage measured (UBmax) / V
Device leakage current scaled to nominal line voltage (IN = (U0 × IBmax): UBmax) / μA
AC polarity N – L:
Maximum device leakage current (IBmax) / μA
Actual line voltage measured (UBmax) / V
Device leakage current scaled to nominal line voltage (IN = (U0 × IBmax): UBmax) / μA
12 Final tasks
TSC/ 12.1 Disinfection program with Puristeril 340, Puristeril plus, Diasteril, or Citrosteril Cleaning – 
MA started. Disinfectant drawn in.
TSC 12.2 During disinfection: Power failure alarm checked. Cleaning – 
Audible alarm, message: Power failure Device is battery-operated. – Confirm
– 12.3 Procedure recorded on the machine card and in the Medical Device Register. Cleaning –  /
– 12.4 All waste properly disposed of. Cleaning – 
– 12.5 All documents created. Cleaning – 
TSC/ 12.6 Only with USER SETUP  Cleaning  Check for residual disinfectant = Manual Standby –  /
MA and disinfection program with Puristeril 340, Puristeril plus or Diasteril:
Disinfection program completed successfully. Absence of residual disinfectant
verified by means of test strips after disinfection program.
Confirmation of the inspection
Service report number: Serial number:
Test equipment used (type and serial number):

Inspection comments:

Date of inspection: Tester's signature: Tester's name:

#FMESIG_3##

Assessment of the inspection

The device is released for its intended use.  Yes  No Date of next inspection:
The inspection label has been attached to the device.
Comments on the assessment:

Date of assessment: Signature of representative of the responsible Name of representative of the responsible
organization: organization:

#FMESIG_4##

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6.4 Explanatory notes for completing the TSC/MA report

Report header

Customer number/customer  Record the customer number/customer name of the end customer.
name

Tester's name  Record the first name and last name of the technician carrying out
the work.

Software version  Record the software version.

Service report number  Record the number of the service call.

Inventory number  Record the inventory number assigned to the device, if any.

Operating hours  Record the operating hours.

Equipment code  Record the equipment code shown on the device (e.g., EC, E-Code).

Serial number  Record the serial number of the device.

Significance of the
columns

Cat. Category of the inspection item in the report (TSC or MA).

No. Number of the inspection item in the report.

Designation Description of the inspection item in the report.

Operating state Required state of the device when carrying out the inspection item.

Measured value/correction  Record the first measured value.

 If the first measured value does not correspond to the target value,
also record the new measured value after the problem has been
corrected.

/NA  Mark the checkbox under  after successfully completing the

inspection item.
 Mark the checkbox under NA if the inspection item does not apply
(e.g., if an option is not present or maintenance procedures are not
required, etc.).

Re: 1 Checks/procedures with device switched off and power plug

unplugged

Re: 1.1 Power supply cord checked for signs of damage.

Operating state: Off
 Check power supply cord for signs of damage.

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Re: 1.2 Checked that the fuse accessible on the outside has the correct
rating. If present, checked seal for damage.
Operating state: Off

 Check that the fuse has the correct rating.

 If there is a seal on the fuse holder, check that it is undamaged.
If the fuse has the correct rating, you can fix a seal over the fuse holder.
There is then no need to check the rechargeable battery fuse in the
future.

Re: 1.3 Checked that all labels and inscriptions are present and legible.
Operating state: Off
 Check that the following labels and inscriptions are present and
legible.

Upper part of front:

1 Radio (option)

Upper part of front:

2 Single-Needle (option) “SN”

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Central part of front:

3
3 Refer to Instructions for Use
since 2013

4 Direction of rotation of the blood pump

5 Rinse port
since 2018 2013 to 2017
4

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Lower part of front:

6 bibag connector
6

7 Suction tube flap

since 2018 2013 to 2017

7
8 bibag flap
since 2018 2013 to 2017

Upper right-hand side:

9
9 Tipping hazard
since 2013

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Central right-hand side:

10 Shunt interlock flap
since 2018 2013 to 2017

10
11
11 Color coding according to the
customer's specification
12 Arrows ↓ of dialysate outlet port (left)
12
13 Arrows ↑ of dialysate inlet port (right)

13

Upper part of rear:

14 IV pole
since 2013

14

Upper part of rear:

15 Top tray (option)
15

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Upper part of rear:

16 Identification label
17 “Made in Germany”

16

17

Central part of rear:

18
18 Filter holder 1 and filter holder 2
since 2018 2013 to 2017

19 19 Between the filter holders

since 2013

20

21
20 Disinfectant connectors
since 2018 2013 to 2017
22

21 Filter holder 1

22 Filter holder 2

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23 Lower part of rear:

24
23 “CDS 1”
25 24 “CDS 2”
26 25 Equipotential bonding connection

27

28
26 Overflow of water inlet chamber
since 2018 2013 to 2017

27 Leakage sensor flap

since 2018 2013 to 2017

28 Rechargeable battery cover

Upper left-hand side:

29 Tipping hazard
since 2013

29

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Central left-hand side:

30 BPM
since 2013

30

Re: 1.4 Device checked for damage and dirt.

Operating state: Off
 Check that the monitor can be swiveled and tilted and maintains the
required position.
 Check the brake. If the brake is not locked, the trolley can be moved
as required.
 Among other things, check the following (e.g., for leaks, corrosion,
broken parts, loose parts):
– EBM
– concentrate connectors
– filter holder
– complete hydraulics
 Check that electrical and mechanical properties are not affected by
damage or dirt.
Target value: The mechanical condition of the device allows further safe
use as intended.

Re: 1.5 Hand crank for manual reinfusion present on device rear.
Operating state: Off

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Fig.: Hand crank (1)

 Check that the hand crank (1) for manual reinfusion is present on the
device rear.

Re: 2 Check, clean, change components

Re: 2.1 Fan filter on the rear of the device replaced.

Operating state: Off
 Replace the fan filter on the rear of the device.

Re: 2.2 O-rings in dialyzer couplings greased and replaced.

Operating state: Off
 Lubricate the new O-rings with UNISILKON L 250 L grease before
installation.
 Replace the O-rings.

Re: 2.3 O-rings on bibag connector greased and replaced.

Operating state: Off
 Lubricate the new O-rings with UNISILKON L 250 L grease before
installation.
 Replace the O-rings.

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Re: 2.4 Interval: Replace every four years.

Molded seal of the substituate unit greased and replaced. The
molded seal is dark gray. O-ring in the substituate unit replaced.
The O-ring is transparent.
Operating state: Off

 Protect components from leaking fluid.

 Loosen the 1 screw (1).

 Loosen the 2 screws (2).

 Loosen the 2 screws (3).

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 Remove the substituate unit.

 Pull apart the substituate unit.

 Pull out the operating lever (4).

 Remove the old molded seal (6) and old O-ring (7).
 Grease the new molded seal (6) with UNISILKON L 250 L grease
before installation.
 Fit the new molded seal (6) and new O-ring (7) as shown. The
molded seal is dark gray. The O-ring is transparent.
The convex side of the seal faces outwards. The orientation of the
sealing lip (5) on the convex side of the seal does not matter.
The concave side of the seal faces inwards.

 Install in reverse order.

 Make sure the drive shaft (7) is seated correctly in the housing.
 Lay the drain tubing of the substituate unit with a uniform gradient
down to the leakage sensor, to avoid creating a trap.

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Re: 2.5 Rinse port lip seal greased and replaced.

Operating state: Off

 Open the rinse port.

 Remove the old lip seal (1).
 Lubricate the new lip seal (1) with UNISILKON L 250 L grease before
fitting it.
 Fit the new lip seal (1).
 Close the rinse port.

Re: 2.6 Arterial and venous occlusion clamps checked.

Operating state: Off

 Check the arterial and venous occlusion clamps for damage at the
following points:
– Catch (1)
– Valve tappet (2)
– Clamping and tappet surfaces (3)
 Push back the catch.
A distinct counterpressure must be felt.
 Release the catch.
The tappet returns to its starting position.

Re: 2.7 Rotors dismantled and cleaned.

Operating state: Off

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Fig.: Example rotor

1
2

 Dismantle and clean the rotors.

 Generally check the rotors for damage.
 Check two line rollers (1) and five guide rollers (2) for damage, wear,
and smooth running.
 Install the rotors correctly.

Re: 2.8 Hydrophobic filter F42 with O-ring replaced.

Air feeding unit checked for fluid ingress.
Operating state: Off

 Remove the screws (1).

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 Chapter 6: Technical safety checks / maintenance procedures

V42

Pneumatic unit

 Check the air feeding unit (2) and hydrophobic filter F42 (3) for fluid
ingress.
 If the possibility of fluid ingress can be ruled out, replace and refit the
hydrophobic filter F42 (3) and O-ring (4).
 If fluid ingress has been detected, replace the complete air feeding
unit (2), hydrophobic filter F42 (3) and O-ring (4).
 Ensure that the hydrophobic filter F42 (3) is oriented
(blue/transparent) as shown in the illustration.

Re: 2.9 Hydrophobic filter F_NBC_3 replaced.

Operating state: Off

Air distributor board

Cassette coupling port

 Replace hydrophobic filter F_NBC_3 (1).

 Ensure that the hydrophobic filter F_NBC_3 (1) is oriented
(blue/transparent) as shown in the illustration.

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Chapter 6: Technical safety checks / maintenance procedures

Re: 2.10 Screws on blood and substituate pump drives tightened

(230 Ncm).
Operating state: Off

 Tighten the 4 screws (1) on the blood and substituate pump drives
respectively (230 Ncm).

Re: 2.11 Blood and substituate pump drives replaced according to interval.
Operating state: Off
Interval: Replace every 36,000 operating hours.
 Replace blood pump drive (see chapter 10.11.25 on page 400).
Interval: Replace every 36,000 operating hours.
 Replace substituate pump drive (see chapter 10.11.25 on
page 400).

Re: 2.12 Cassette contact mat and frame replaced.

Operating state: Off

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 Chapter 6: Technical safety checks / maintenance procedures

Note
Malfunction of the actuator-sensor unit due to dirt particles
 Check the rear of the new cassette contact mat for contamination.
 If necessary, clean the rear of the new cassette contact mat using a
lint-free cloth with no cleaning agent.
 Install the new cassette contact mat immediately after removing the
old one.

 Remove the 8 screws (1).

 Detach the cassette contact mat (2).

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Chapter 6: Technical safety checks / maintenance procedures

 Remove the old frame (3).

 Lightly grease the sealing groove (4) of the actuator-sensor unit with
POLYLUB GLY151 using a Texwipe swab.
 Ensure that the air channels and cassette sensors are free of
grease.

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 Chapter 6: Technical safety checks / maintenance procedures

Too much grease could clog the air channels of the actuator-sensor unit
or impair the functioning of the cassette sensors.

5
6

 Pull the outer seal (5) of the cassette contact mat over the lip (6)
around the frame.

 Insert the cassette contact mat together with the frame on the
cassette positioning pins (7).
 Push the cassette contact mat evenly into the sealing groove at the
marked position.
 Screw the frame into place using the 8 screws provided. This
prevents the frame from being damaged by unsuitable screws.
Specified wrench torque for the 8 screws: 90 Ncm

 Correctly insert the cassette contact mat near the substituate unit (8)
with the removal tool for O-rings.

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Chapter 6: Technical safety checks / maintenance procedures

 Press down the cassette contact mat evenly at the marked positions.

Re: 2.13 O-rings and port seals of the cassette coupling port/cassette
deaeration port greased and replaced.
Operating state: Off

 Cut off the pneumatic tubings (1) directly at the adapter fittings.

 Remove the adapters (2) using a socket wrench (size 10).

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 Chapter 6: Technical safety checks / maintenance procedures

 Push the door ports (3) out of the door in the direction of the arrow
using a blunt implement.
 Remove the door ports (3).
 Dispose of old O-rings and old port seals.
Used seals must not be reused.

 Apply a thin layer of BARRIERTA L55/1 grease to the new O-rings

(4) before fitting them.
 Apply a thin layer of BARRIERTA L55/1 grease to the new port seals
(7) at the point shown before fitting them.
 Assemble the door ports in the sequence and orientation shown.
When carrying out this work, ensure the following:
– The air channel (5) is free of grease.
– The plastic washer (6) and the port seal (7) are compatible with
each other.
– The ridge on the plastic washer (6) is aligned with the groove on
the port seal (7).

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Chapter 6: Technical safety checks / maintenance procedures

 Insert the door ports into the door and manually press in until they
stop.
 Screw in the adapters using a socket wrench (size 10).
Specified wrench torque for the adapters: 350 Ncm
 Continue installing in reverse order of removal.
 Perform the pneumatics test (see chapter 9.5.3.1 on page 241).
Additionally with Single-Needle (option):
 Perform the Single-Needle pneumatics test (option)
(see chapter 9.5.3.2 on page 243).

Re: 2.14 Interval: Replace every six years.

Tubing in substituate valve (V31) replaced. New tube shortened to
70 mm in total. Tube clip fitted according to angled nozzle used.
Operating state: Off

3
4
5

 Remove the tube clip (4) from the angled nozzle (5).
 Pull off the tubing (3) from the angled nozzle (5) and shorten it by
about 1 cm.
 Remove the tube clip (1).
 Remove the tubing (2).
 New tubing (2) shortened to 70 mm in total.
 Insert the new tubing (2) into the substituate valve.
 Fit a new tube clip (4).
– White angled nozzle (5): SNP-G 2 tube clip
– Gray angled nozzle (5): SNP-G 1.5 tube clip
 Fit a new tube clip (1).
– Tube clip SNP-G 1.5
 Fit the tubing (3) on the angled nozzle (5).

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 Chapter 6: Technical safety checks / maintenance procedures

Re: 2.15 Filter F06 replaced.

Operating state: Off

EBM

V23

 Remove the old filter F06 – hydrophobic compressor filter (1).

 Install the new reinforced filter F06 – hydrophobic compressor filter
(1).
 Ensure that the reinforced hydrophobic filter F06 (1) is oriented
(blue/transparent) as shown in the illustration.

Re: 2.16 Leakage sensors (EBM, S35) inspected visually. Leakage sensors
cleaned.
Operating state: Off
 Visually check leakage sensors for dirt and mechanical damage.
The paint coat of the leakage sensors must not be damaged.

Fig.: Leakage sensor – EBM (1)

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Chapter 6: Technical safety checks / maintenance procedures

Fig.: Leakage sensor – hydraulics unit S35 (2)

Re: 2.17 Filters F11 acid suction tube and F12 bicarbonate suction tube
checked for damage.
New greased seals inserted in the acid suction tube and
bicarbonate suction tube.
Operating state: Off
 Check filters F11 acid suction tube and F12 bicarbonate suction tube
for damage.

Fig.: Cross-section of molded seal at the concentrate suction tube

 Remove the old seals (1) from the concentrate suction tube and the
bicarbonate suction tube.
 Lubricate the new seals (1) with UNISILKON L 250 L grease before
installation.
 Mount the new seals (1) on the concentrate suction tube and the
bicarbonate suction tube as shown.
The convex side of the seal faces outwards. The orientation of the
sealing lip (2) on the convex side of the seal does not matter.
The concave side of the seal faces inwards.

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 Chapter 6: Technical safety checks / maintenance procedures

Re: 2.18 Check valve for water inlet (A05) checked for proper function.
Operating state: Off

1
2

 Switch off the device.

 Remove the inlet tubing (1) from A05 (4).
 Remove the outlet tubing (2) from A05 (4).
 Connect an external reference meter (3) and a syringe to the outlet
(2) of A05 (4).
 Using a syringe, build up a pressure of > 2.5 bar.
 Check the display of the reference meter after 1 minute.
Target value after 1 minute: between (built-up pressure – 60 mbar) and
exact built-up pressure
Example:
Built-up pressure: 2557 mbar
Target value after 1 minute: 2497 mbar to 2557 mbar
After the measurement, proceed as follows:
 Remove the external reference meter (3) and the syringe from A05
(4).
 Disinfect the inlet tubing (1) outlet tubing (2) and A05 (4) with an
approved alcohol-based surface disinfectant (e.g., Freka-NOL).
 Fit the inlet side tubing (1) (from V38) onto A05 (4) and install the
tube clamp.
 Fit the outlet side tubing (2) (from H04) onto A05 (4) and install the
tube clamp.

Re: 2.19 Filters F01, F08, F14, F15, F17 and F18 replaced.
O-rings F01, F14 and F15 greased and replaced.
Operating state: Off

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Chapter 6: Technical safety checks / maintenance procedures

Fig.: F08 – Filter for UF pump

 Change filter F08 for the UF pump (1).

Fig.: F17 and F18 – bibag filters

 Change filter F17 for the bibag inlet (2).

 Change filter F18 for the bibag outlet (3).
 Check the flow direction of filters F17 (2) and F18 (3).

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 Chapter 6: Technical safety checks / maintenance procedures

Fig.: F01 – water inlet filter with bayonet lock

5
6
7

 Remove the bayonet lock (4) from the media supply rail.
 Remove the old filter (5).
 Remove the old O-ring (6).
 Lubricate the new O-ring (6) with UNISILKON L 250 L grease before
installation.
 Install the new O-ring (6).
 Install the new filter (5).
 Disinfect all components with an approved alcohol-based surface
disinfectant (e.g., Freka-NOL).
 Insert the bayonet lock (4) into the media supply rail and secure it.
 Ensure that the mark (7) faces upward.

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Chapter 6: Technical safety checks / maintenance procedures

Fig.: F01 – water inlet filter with permeate quick-lock

8
9

10
11

 Remove the permeate quick-lock from the media supply rail.

 Remove the old filter (8).
 Remove the old O-ring (9).
 Lubricate the new O-ring (9) with UNISILKON L 250 L grease before
installation.
 Lubricate the new O-ring (10) with UNISILKON L 250 L grease
before installation.
 Lubricate the thread (11) with UNISILKON L 250 L grease before
installation.
 Install the new O-ring (9).
 Install the new filter (8).
 Disinfect all components with an approved alcohol-based surface
disinfectant (e.g., Freka-NOL).
 Insert the permeate quick-lock into the media supply rail and secure
it.

Fig.: F14 and F15 – CDS filters (options)

12
13

 Remove the bayonet locks (12) and (13) from the media supply rail.
 Remove the old filters.
 Remove the old O-rings.

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 Chapter 6: Technical safety checks / maintenance procedures

 Lubricate the new O-rings with UNISILKON L 250 L grease before

installation.
 Install the new O-rings.
 Install the new filters.
– Filter F14 in CDS 1 (12)
– Filter F15 in CDS 2 (13)
 Insert the bayonet locks (12) and (13) into the media supply rail and
secure them.
 Ensure that the marks (12) and (13) face upward.

Re: 2.20 Only if the filter F07 is connected:

Filter F07 replaced. O-ring F07 greased and replaced.
Operating state: Off

Fig.: F07 – Filter for dialysis fluid

 Remove the old filter.

 Remove the old O-ring.
 Lubricate the new O-ring with UNISILKON L 250 L grease before
installation.
 Install the new O-ring.
 Install the new filter.
 Ensure that the mark (1) faces upward.

Re: 2.21 Only if the external dialysate filter is in the dialysate outlet port
(left):
Filter insert replaced.
Operating state: Off

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Chapter 6: Technical safety checks / maintenance procedures

Fig.: External dialysate filter in the dialysate outlet port (left)

 Unscrew the external dialysate filter (1).

 Replace the filter insert.
 Screw the external dialysate filter (1) back together.

Re: 2.22 Dirty or unsightly tubes replaced.

Operating state: Off
 Check the tubings. Particularly check the dialysate inlet tube and the
dialysate outlet tube.

Re: 2.23 Filters F10 and F16 disinfectant container checked for damage.
O-rings H20 and H35 greased and replaced.
Operating state: Off

Fig.: F10 – yellow container connector with filter on the suction tube

 Check the suction tube filter (1) in the Diasteril, Citrosteril, Puristeril
340 or Puristeril Plus disinfectant container.

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 Chapter 6: Technical safety checks / maintenance procedures

Fig.: O-ring in the disinfectant connector H20 (yellow)

 Remove the bayonet lock (2).

 Remove the old O-ring.
 Lubricate the new O-ring with UNISILKON L 250 L grease before
installation.
 Install the new O-ring.
 Insert the bayonet lock (2) and secure it.
 Ensure that the mark (2) faces upward.

Fig.: F16 – Black container connector with filter on the suction tube

 Check the suction tube filter (3) in the Sporotal 100 disinfectant
container.

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Chapter 6: Technical safety checks / maintenance procedures

Fig.: O-ring in the disinfectant connector H35 (black)

 Remove the bayonet lock (4).

 Remove the old O-ring.
 Lubricate the new O-ring with UNISILKON L 250 L grease before
installation.
 Install the new O-ring.
 Insert the bayonet lock (4) and secure it.
 Ensure that the mark (4) faces upward.

Fig.: Disinfectant container filter

 Replace the disinfectant container filter (5) only if present.

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 Chapter 6: Technical safety checks / maintenance procedures

Re: 2.24 Only applicable when using Puristeril 340, Puristeril plus:
Disinfectant valve V20 replaced. The disinfectant valve has a
yellow identification label.
Operating state: Off

Requirement Use disinfectant valve suitable for disinfectant. The disinfectant valve
has a yellow identification label.
 Read the information under "Considerations for working on the
device" (see chapter 2.5 on page 19).
 Observe all safety measures applicable to the handling of
disinfectants.

5 2

4 3

 Detach disinfectant from disinfectant connector H20 (6). The

disinfectant connector H20 is marked in yellow.
 Connect dialysis water to disinfectant connector H20 (6).
 In the SERVICE  DIAGNOSTICS  Hydraulics  Test menu, run
the Suction V20 function (see chapter 9.5.6 on page 246).
 Detach dialysis water from disinfectant connector H20 (6).
 Pull the tubing (5) off disinfectant valve V20 (4). The tube is black
and is marked yellow.
 Remove the old disinfectant valve V20 (4).
 Install the new disinfectant valve V20 (4).
 Attach the tubing (5) to disinfectant valve V20 (4). The tube is black
and is marked yellow.
 If necessary: Replace tubing with a new 300 mm long black tube
with yellow marking.

Fresenius Medical Care 6008 SM-EN 11A-2022 175

Chapter 6: Technical safety checks / maintenance procedures

 Check the following points for disinfectant valve V20 (4):

– Disinfectant valve V20 is positioned on the left
– Disinfectant valve V20 is marked with V20
– Disinfectant valve V20 has a yellow identification label
– Plug for disinfectant valve V20is connected
– The tube (5) is black and is marked yellow
– The tube (5) is connected to disinfectant connector H20 (6)
 Check the following points for disinfectant valve V34 (3):
– Disinfectant valve V34 is positioned on the right
– Disinfectant valve V34 is marked with V34
– Disinfectant valve V34 has a yellow identification label
– Plug for disinfectant valve V34 is connected
– The tube (2) is black and is not marked
– The tube (2) is connected to disinfectant connector H35 (1)

Re: 2.25 Only when using Sporotal 100 and suction via disinfectant
connector H35:
Disinfectant valve V34 replaced. The disinfectant valve has a
yellow identification label.
Operating state: Off

Requirement Use disinfectant valve suitable for disinfectant. The disinfectant valve
has a yellow identification label.
 Read the information under "Considerations for working on the
device" (see chapter 2.5 on page 19).
 Observe all safety measures applicable to the handling of
disinfectants.

5 2

4 3

 Detach disinfectant from disinfectant connector H35 (1). The

disinfectant connector H35 is marked in black.
 Connect dialysis water to disinfectant connector H35 (1).

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 Chapter 6: Technical safety checks / maintenance procedures

 In the SERVICE  DIAGNOSTICS  Hydraulics  Test menu, run

the Suction V34 function (see chapter 9.5.6 on page 246).
 Detach dialysis water from disinfectant connector H35 (1).
 Pull the tubing (2) off disinfectant valve V34 (3). The tube is black
and is not marked.
 Remove the old disinfectant valve V34 (3).
 Install the new disinfectant valve V34 (3).
 Connect the tubing (2) to disinfectant valve V34 (3).
 If necessary: Replace tubing with a new 300 mm long black tube.
 Check the following points for disinfectant valve V20 (4):
– Disinfectant valve V20 is positioned on the left
– Disinfectant valve V20 is marked with V20
– Disinfectant valve V20 has a yellow identification label
– Plug for disinfectant valve V20is connected
– The tube (5) is black and is marked yellow
– The tube (5) is connected to disinfectant connector H20 (6)
 Check the following points for disinfectant valve V34 (3):
– Disinfectant valve V34 is positioned on the right
– Disinfectant valve V34 is marked with V34
– Disinfectant valve V34 has a yellow identification label
– Plug for disinfectant valve V34 is connected
– The tube (2) is black and is not marked
– The tube (2) is connected to disinfectant connector H35 (1)

Re: 2.26 Interval: Replace every four years.

Rechargeable battery for device replaced.
Operating state: Off

Fig.: Rechargeable battery for device

 Replace the battery pack (1).

 Follow the instructions in the chapter on removal and installation
(see chapter 10.8.1 on page 296).

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Chapter 6: Technical safety checks / maintenance procedures

Re: 2.27 Interval: Replace every four years.

Battery on PC board replaced.
Operating state: Off

Fig.: Battery on PC board.

Replace the battery (1) on the PC board quickly to avoid data loss.
 Remove the old battery from its receptacle.
 Ensure correct polarity of the new battery.
 Insert the new battery into its receptacle.
 Press lightly on battery until it clicks into place.
 Check the date and time and adjust as necessary.

Re: 2.28 Interval: Replace every four years.

Battery of power supply unit with PCB LP 1105-1 (VMA) replaced.
Operating state: Off

Warning
Risk of injury as a result of an electric shock
Touching live parts will cause an electric shock.
 Unplug the power plug before opening the power supply unit.

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 Chapter 6: Technical safety checks / maintenance procedures

Fig.: Battery of power supply unit with serial number section VMA.
IC25

C35
C37
R41

IC22
R42

IC3
R76
R81
C17 C25
D9

R92
C34 C2
IC30 R38 C4
R43

IC7
C3

R95 R97
R96 R98
R36 R80

IC21
DR11
C5
R35

T10
R44 R4
C6 R1
R47
R100

IC8

MP1
D15 R101
R99
DR1
R40 R39 R79

X3

R102

T7
R82 R73
R37 C52
R74 T11
R49
R34

1
2
DR2 R68 R32

T9
C13 R51

DR8
R33

+C32
R50

C31

C33
IC36 R84
R30

IC11
R31
IC29 R29
R12

C51
R86
T5 C43

R87

D12
IC27
R91
X2
1
R65 IC15 IC20
DR7 R57 D17

T16 D13
R63 R83
R53

1
2
R64 R122

DR9

C10

C14
C30

C8

R119
T18

D11
R61
R62 T1 R54
R58 C21 C20
C27 R60 R23
C18

DR3
R59 20 1 R90 R109 C47

IC5
R56 R55

IC10
R2 21 80
R21
C49 C50

D16
D1 C38 R52 C28
IC13 C9 R103

IC6
R77 C12
D2 Q1 R94
C36 R88
R78 R85 40 61

R75
C26 C48
41 60

IC24
R45 C42 C29

T8

R104
R9

C7
R46
R48

D10
C40
+

13

5
R66

14
C11

4
D14

IC14
Q2

1
20

30
21

29
R7 IC26 C1

C16

BH1
BA1
IC4

44

34

X4
33
1
IC2

IC1

1
2
C15

11

23
12

22
R5

T6
R8
R28

IC12

D6 IC28

R19

R25

R26

R72
R3
R6
IC17 IC19 IC18 IC23
RL1

D4
MP2 C24

R67 R69 R70

R13
R27
R17
R18
R24
R20
ME1

IC37
IC16

R71
C39

1
C23 R10

X_HEIZER
C22
+

X_POWER
T4

R15 R107

ME2

R108
R106
R14
T2 T12

D8

R16
D7

R93
D5

R11
R89
T3

Replace the battery (1) on the PCB LP 1105-1 quickly to avoid data
loss.
 Remove the old battery from its receptacle.
 Ensure correct polarity of the new battery.
 Insert the new battery into its receptacle.
 Press lightly on battery until it clicks into place.
 After replacing the battery, switch the device on.
The current time is applied after the next power-on.
 Erase the error memory of the PSU.
 Switch the device off and back on again.
 Check the error memory of the PSU.
Target: there are no entries (e.g., RTC3) in the error memory of the
PSU.

Re: 2.29 Interval: Replace every ten years.

Battery of power supply unit with PCB LP 1186 (WMT) replaced.
Operating state: Off

Warning
Risk of injury as a result of an electric shock
Touching live parts will cause an electric shock.
 Unplug the power plug before opening the power supply unit.

Fresenius Medical Care 6008 SM-EN 11A-2022 179

Chapter 6: Technical safety checks / maintenance procedures

Fig.: Battery of power supply unit with serial number section WMT.

C44
C48
IC26
R52
R53

C71
C74
C70

R190
DR8

BAH1
IC28
+ -

C90
IC18

R198

R47 D8
C58
C41
C61 DR9 R127

R112
R109
D23

C18
C66
DR3 C45

C94

C62
IC19 R128

DR4

R40
C68
D24
C46 C42
T34 T10

C63

C53

C24
C47

DR5
C69
C43

R119
R23

R41
DR6 R98 R16

R195
R99 R61

T13
C59

R100
R107

C72
R58
R57
R51
C50

Q1

C22
DR7
C8
IC32

IC4
D36

R139
D20
R187

X3

T17
R188 R137 C15

R113
R181
R149 R138
C16

DR10

R147 R146
C28 C75

Q2
R150

RL1
C29 C73 R6

R180 R114
T32
25 C20 D29 1

C64
R1

R177
26 100
R115 R199
R120 R2

C67 D18
R189 R3

C9
R213

C31
T18

D37
IC7

R110

C32
T31

R197

C10
1

C60

R63
R176
D17 D15 R14

R7
D21 50 76

T14

51

75
R186

T16

R9
IC3
D35
D22 C25
R153 R101 D14
C76 D16 C19 T2

R86
R173 R178 R102
R165 R48 C91

T33
R151

R87
C39

R209
C84

R185
R212
R152 C23

R166
R184 R8

R161

R211
R169 C40

IC35 C82
R182 R4

D34
R24

D41
R168 D32
D33 R88

R183

R59
R172 R12

C34

D27
C1

C11
D26 IC8

R144
R143
R95
R194

C96
R13

C85

D28
R170 R171 IC5

R28
R89
R79
R174 R193 R179 R94 R72

R175
R132 R141
C80 IC1

C35
C57
C83
C81 R126 IC14 IC20 R142
D1

R133
R131
R42 R33

R96

D12
R90
R134

R34

T6
T22 T26 T27 R43 D3

R129

C12
C30

R35
T8
R5

C36
R36 R25
IC25 R37

T20
T25 R29
R38 C3 C2

C51
R167

R91
R80

R192

D4
C26 R26
C56
C93
IC21 R201

D5
R200 R27

T19
D38 R15
R121 R103 R92 IC9 C13
R202

R191
R122 R205
R123 R204
R203 T5

D39 T36
R116 R117
R17

T35
R30
R18

C92 D40

D42
C95

IC10
R210
R207 R140

IC36
R208
R206

T23

R124
R130
R135 R136
T21
T24 IC23 C14

R158 R31
D19

IC34
R104

C17 R157
C65
R60
R93

R39
IC17 IC6
RL2
IC15 IC11

R50
C77 DR1
R81 R64 D6

R19
C5

IC12
IC2

R20
C6
C7

R21
R32
C21
C86

C33

IC13

R22
R73

R66
R196

R65

D30
T12

R74
R54

1
X_HEIZER
R44
D13

R55

R45
C37 R83
R82

X_POWER
T7
T11
R84

C27
R68
+
T15

D7
R69
R105

R56

R46
R70
R1
06
R97

D11
T4 T1

Replace the battery (1) on the PCB LP 1186 quickly to avoid data loss.
 Remove the old battery from its receptacle.
 Ensure correct polarity of the new battery.
 Insert the new battery into its receptacle.
 Press lightly on battery until it clicks into place.
 After replacing the battery, switch the device on.
The current time is applied after the next power-on.
 Erase the error memory of the PSU.
 Switch the device off and back on again.
 Check the error memory of the PSU.
Target: there are no entries (e.g., RTC3) in the error memory of the
PSU.

Re: 3 Hydraulics

Re: 3.1 Only for software version ≤ 2.44 or SETUP  Settings Hydraulics
 Auto calibration  Degassing (P01) = No:
Degassing pump calibrated.
Operating state: Service, CALIBRATE
Requirement: The pressure transducers (S03/S07/S15/S16) are
calibrated.

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Fig.: Loading pressure valve, balancing chamber

A02

 Select the Degassing (A02/P01) field.

 Select the Start calibration field.
Message: Please wait. Filling phase in progress! – Stop
Message: Please wait. Plausibility check S03/S07/S15/S16 in progress.
– Stop
Message: Adjustment of relief valve A02 between 1800 and 1900 mbar
Pressure: # mbar – Confirm – Stop.
 If the pressure value is within the defined range, select the Confirm
field.
If the pressure value is not within the defined range, the pressure must
be adjusted using A02.
 Set the pressure value using A02.
 Then select the Confirm field.
Message: Initial degassing pump test in progress.
Automatic calibration starts with the "initial degassing pump test"
(checking the status of the degassing pump).
Message: Please wait. Filling phase in progress! – Stop.
Message: Please wait. Automatic degassing calibration in progress.
Speed P01: # rpm Pressure S16: # mbar – Stop.
After automatic calibration has been completed, the following message
will be displayed: Adjustment of relief valve A02 between 1800 and
1900 mbar Pressure: # mbar – Confirm – Stop.
 If the pressure value is within the defined range, select the Confirm
field.
After calibration has been completed successfully, the CALIBRATE
menu is displayed.

Re: 3.2 Loading pressure of balancing chamber checked.

Operating state: Service, CALIBRATE
Requirement: The pressure transducers (S03/S07/S15/S16) are
calibrated.

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Fig.: Loading pressure valve, balancing chamber

A02

 Select the Degassing (A02/P01) field.

 Select the Loading pressure test field.
The loading pressure (A02) is determined.
Message: Loading pressure balancing chamber (A02) between 1800 -
1900 mbar Pressure: # mbar – Stop.
 Check the loading pressure displayed and record it.
Target value: 1800 mbar to 1900 mbar

Re: 3.3 Flow pump calibrated.

Operating state: Service, CALIBRATE
Requirement: The pressure transducers (S03/S07/S15/S16) are
calibrated.

Fig.: Pressure limitation valve

A03

 Select the Flow pump (P03/A03) field.

 Select the Start calibration field.
Message: Adjustment of relief valve A03 between 2450 and 2650 mbar
Loading pressure: # mbar – Confirm – Stop.
 If the pressure value is within the defined range, select the Confirm
field.

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After calibration has been completed successfully, the CALIBRATE

menu is displayed.
If the pressure value is not within the defined range, the pressure must
be readjusted using A03.
 Set the pressure value using A03.
 Then select the Confirm field.
After calibration has been completed successfully, the CALIBRATE
menu is displayed.

Note
Dialysate flow problems due to unfavorable adjustment values
If the flow deviates from the selected dialysate flow by ±20 ml/min or
–10 %, the flow pump (P03) will adjust the dialysate flow automatically.
While the flow pump (P03) is adjusting the flow, it is shown in yellow in
the flow diagram. When the flow pump (P03) in the flow diagram is once
again displayed in red with yellow circles, this means a new adjustment
value has been set and stored.
 Allow each dialysate flow in turn to be adjusted from 100 ml/min to
1000 ml/min in 100 ml/min increments.
– Select the CALIBRATE menu.
– Set the Desired flow field.
– Select the Flow diagram field (waves).
– Ensure that the flow pump (P03) in the flow diagram continues to
be displayed in red with yellow circles over several balancing
chamber switching cycles.

Re: 3.4 Maximum water inflow when the reverse osmosis unit is running
under its normal load checked.
Operating state: Service, CALIBRATE
Requirements:
The dialysis water inlet pressure and the dialysis water inlet rate are
subject to changes if more devices than one are operated on one
reverse osmosis unit. The maximum water inflow (Max. water inflow)
should therefore be checked and set under ordinary treatment
conditions. This means, for example, that if an average of 30 devices
are used for treatment in normal operation, the reverse osmosis unit
should also be loaded with 30 devices.
– Observe environmental conditions.
– Make sure the reverse osmosis unit is running under its normal load.

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Tip
If water deficiency alarms occur sporadically, the maximum water inflow
should be checked with the following loads on the reverse osmosis unit.
In each case, the maximum water inflow should be within the limits
specified.
Low load: Load the reverse osmosis unit with approx. every sixth
device.
Medium load: Load the reverse osmosis unit with approx. every
second device.
Maximum load: Load the reverse osmosis unit with all devices.

 Select the SERVICE menu.

 Select the CALIBRATE menu.
The hydraulics are working.
 Select the field in the status bar to display the animated flow
diagram.
By repeatedly selecting the field, it is possible to switch between
the EBM Flow Diagram and the Flow diagram.

Note
Incorrect maximum water inflow value due to water deficiency
alarm
In the event of a water deficiency alarm, the flow diagram shows the
previously measured value of the Max. water inflow in red.
 Correct the water deficiency alarm.

Note
A dialysate flow of 1000 ml/min cannot be reliably achieved due to
insufficient water inflow
If the maximum water inflow is less than 1300 ml/min, a dialysate flow
of 1000 ml/min cannot be reliably achieved.
 Set the maximum water inflow to ≥ 1300 ml/min.

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Note
Water deficiency alarm associated with widely fluctuating dialysis
water inlet pressure
A widely fluctuating dialysis water inlet pressure can lead to a water
deficiency alarm.
 The maximum water inflow should preferably be accomplished with
a dialysis water inlet pressure of 2.5 to 4.0 bar.
 The maximum water inflow can, in exceptional cases, be set to a
value up to 1800 ml/min with a dialysis water inlet pressure of 2.5 to
4.0 bar.
Exceeding the target value of 1300 ml/min to 1550 ml/min may cause
other devices to experience water deficiency problems.

 Wait at least one minute until the value has stabilized.

 Check the Max. water inflow [ml/min] value in the animated flow
diagram.
Target value: 1300 ml/min to 1550 ml/min

Re: 3.5 Only if concentrate containers are used exclusively:

Level sensor (S17) checked.
Operating state: Service, CALIBRATE, Flow diagram
 Bridge the pins of the level sensor (S17).
 Check the level sensor (S17) in the flow diagram.
 Remove the bridge from the level sensor (S17).

Re: 3.6 Only if bicarbonate containers are used exclusively:

Level sensor (S19) checked.
Operating state: Service, CALIBRATE, Flow diagram
 Bridge the pins of the level sensor (S19).
 Check the level sensor (S19) in the flow diagram.
 Remove the bridge from the level sensor (S19).

Re: 3.7 Only if CDS (option) used exclusively:

Function of suction tube flap checked.
Operating state: Service, CALIBRATE, Flow diagram
 Check the engagement of the suction tube flap.
 Check the microswitch of the suction tube flap.

Re: 4 Dialysate pressure

Re: 4.1 Zero point S03/S07 checked.

Operating state: Service, CALIBRATE
Requirement: The device must be closed.
 Attach a reference meter to the lowest point of the IV pole.

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 Connect the dialyzer couplings to the reference meter.

 Switch the flow on until the dialysate lines and the reference meter
are cleared of air.
 Switch the flow off.
 Open the vent valve (reference meter).
 Fill syringe with fluid.
 Use the filled syringe to set a value of 0 mbar (±5 mbar) via the vent
valve.
 Check S03. Target value: S03 = Display of reference meter +
(+11 mbar to +71 mbar)
 Check S07. Target value: S07 = Display of reference meter +
(+11 mbar to +71 mbar)

Re: 4.2 Slope S03/S07 (+) checked.

Operating state: Service, CALIBRATE
Requirement: The device must be closed.
 Attach a reference meter to the lowest point of the IV pole.
 Connect the dialyzer couplings to the reference meter.
 Switch the flow on until the dialysate lines and the reference meter
are cleared of air.
 Switch the flow off.
 Open the vent valve (reference meter).
 Fill syringe with fluid.
 Use the filled syringe to set a value of +533 mbar (±26 mbar) via the
vent valve.
 Check S03. Target value: S03 = Display of reference meter +
(+11 mbar to +71 mbar)
 Check S07. Target value: S07 = Display of reference meter +
(+11 mbar to +71 mbar)

Re: 4.3 Slope S03/S07 (–) checked.

Operating state: Service, CALIBRATE
Requirement: The device must be closed.
 Attach a reference meter to the lowest point of the IV pole.
 Connect the dialyzer couplings to the reference meter.
 Switch the flow on until the dialysate lines and the reference meter
are cleared of air.
 Switch the flow off.
 Open the vent valve (reference meter).
 Fill syringe with fluid.
 Use the filled syringe to set a value of –533 mbar (±26 mbar) via the
vent valve.

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 Check S03. Target value: S03 = Display of reference meter +

(+11 mbar to +71 mbar)
 Check S07. Target value: S07 = Display of reference meter +
(+11 mbar to +71 mbar)

Re: 5 Blood leak detector

Re: 5.1 Blood leak detector checked.

Operating state: Service, CALIBRATE
Requirements:
– The device must be closed (avoid exposure to external light).
– Flow on, flow 500 ml/min.
– Dialysate temperature: 34 °C to 39 °C.
– Stable conductivity.
 Check blood leak voltage.
Target value for blood leak voltage: 4.8 Volt to 5.2 Volt
 Check dimness voltage.
Target value for dimness voltage: 4.7 Volt to 5.3 Volt

Re: 6 Temperature/conductivity

Re: 6.1 Temperature tested with reference meter.

Operating state: Service, CALIBRATE
Requirements:
– The device must be closed.
– Dialysate temperature: specified value 37.0 °C.
– Flow on, flow 500 ml/min.
 Attach a reference meter to the lowest point of the IV pole.
 Connect the dialyzer couplings to the reference meter.
 Switch the flow on.
 Wait until the values are stable within a range from 36.8 °C to
37.2 °C (on the display of the device).
 Compare the sensor of the reference meter with sensor PT7:
Target value for temperature difference (reference meter – PT7):
–0.5 °C to +0.2 °C

Re: 6.2 Conductivity tested with reference meter.

Operating state: Service, CALIBRATE
Requirements:
– The device must be closed.
– If a bibag is generally used, the test must be performed with a bibag.
– Flow on.
 Make sure that the concentrates connected correspond to the set
concentrate type.
 Attach a reference meter to the lowest point of the IV pole.
 Connect the dialyzer couplings to the reference meter.

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 Switch the flow on.

 Wait until the values at CD7 are stable within a range from
13.5 mS/cm to 14.5 mS/cm.
 Compare the sensor of the reference meter with sensor CD7:
Target value for conductivity difference (reference meter – CD7):
±0.15 mS/cm

Re: 7 OCM

Re: 7.1 Conductivity difference between CD7 and CD9 checked.

Operating state: Service, CALIBRATE
Requirements:
– The device must be closed.
– If a bibag is generally used, the test must be performed with a bibag.
 Switch the flow on.
 Wait until the values at CD7 and CD9 are stable within a range from
13.5 mS/cm to 14.5 mS/cm.
 Compare sensors CD7 and CD9:
Target value for conductivity difference (CD7 – CD9): ±0.05 mS/cm
If conductivity difference > ±0.05 mS/cm:
 Calibrate the conductivity (see chapter 9.4.6 on page 233).
 Calibrate the OCM (see chapter 9.4.9 on page 235).

Re: 8 Extracorporeal components

Re: 8.1 Cassette sensors calibrated.

Operating state: Service, CALIBRATE
Requirement: Cassette system not inserted.

 If the device is not switched on and negative pressure has not been
created, switch the device on and wait until the system compressor
is no longer active (see chapter 9.3 on page 224).
 Check that the pneumatics negative pressure (1) displayed in the
EBM Flow Diagram is stable.

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 Ensure that the cassette contact mat is still correctly seated at the
marked positions after the negative pressure has been created.
Example pictures of improperly installed cassette contact mats (see
chapter 10.15.3 on page 484).
 Close the door.
 Check the Installation altitude field in the SETUP  Settings
Hydraulics menu.
 Select the Start calibration field in the CALIBRATE  Cassette
sensors menu.
Cassette sensors are calibrated.
 Follow the on-screen instructions.
Message: Calibration of the cassette sensors was successfully
completed. – Confirm
 Select the Confirm field.

Re: 8.2 Function of substituate unit checked.

Operating state: Service, DIAGNOSTICS
 Select the DIAGNOSTICS  Hydraulics  Test menu.
 Select the Substituate unit  Move to service pos. field.

Re: 8.3 Function of Blood System Stop button checked.

Operating state: Service, DIAGNOSTICS
 Press the Blood System Stop button below the touchscreen.
When functioning correctly, the message: The "Bld. system Stop" key
has been pressed. is shown.

Re: 8.4 Pneumatics test performed.

Operating state: Service, DIAGNOSTICS
 Select the DIAGNOSTICS  EBM  Test menu.
 Select the Pneumatics – Test  Start field.
The automatic pneumatics test is performed.

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 Follow the instructions on the screen.

Re: 8.5 Single-Needle pneumatics test (option) performed.

Operating state: Service, DIAGNOSTICS
 Select the DIAGNOSTICS  EBM  Test menu.
 Select the SN – Pneumatics – Test  Start field.
The automatic pneumatics test is performed.
 Follow the instructions on the screen.

Re: 9 Options

Re: 9.1 BPM (option): The technical measurement checks (TMCs)

additionally required are country-specific and form part of the
technical safety checks (TSCs).
Two different versions of the blood pressure monitor can be used with
the device. The version can be identified in the SERVICE  SETUP 
USER SETUP  BPM  Preselected pressure field.
BPM version 1:
The value in the Preselected pressure field is adjustable.
BPM version 2:
The value in the Preselected pressure field is Automatic.

Re: 9.1.1 Blood pressure cuff and pressure tubing are correctly connected
to the BPM (option).
Operating state: Service
 Check whether the blood pressure cuff and the pressure tubing are
correctly connected to the BPM (option).

Re: 9.1.2 Blood pressure cuff and pressure tubing checked for damage.
Damaged parts replaced.
Operating state: Service
 Check the blood pressure cuff and pressure tubing for damage.
 Replace damaged parts.

Re: 9.1.3 BPM (option) checked for leaks.

Operating state: Service, DIAGNOSTICS
 Connect the pressure tubing to the BPM (option).
 Connect the blood pressure cuff to the pressure tubing.
 Wrap the blood pressure cuff around a rigid metal vessel.
 In the SERVICE  DIAGNOSTICS  BPM menu, select the Info /
Test field.
 Additionally with BPM version 1:
Select the Preselected pressure field and set the value 250 mmHg.
 Select the Leakage test field.

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BPM version 1:
The BPM is checked for leaks for about four minutes.
BPM version 2:
The value in the Preselected pressure field is changed to Automatic
and the BPM is checked for leaks for about four minutes.
 Check the Maximum leakage rate value.
Target value Maximum leakage rate: ≤ 6 mmHg/min

Re: 9.1.4 BPM (option) checked against the required pressures.

Operating state: Service, DIAGNOSTICS
External test equipment: UMED II, UMED or reference meter with a
measuring accuracy of ±1 mmHg in the specified measuring range

1 Rigid metal vessel

2 Reference meter
3 Aspirator bulb with drain valve
4 Pressure connector
 In the SERVICE  DIAGNOSTICS  BPM menu, select the Info /
Test field.
 Remove the pressure tubing and blood pressure cuff from the BPM
(option).
 Connect a rigid metal vessel (1), a reference meter (2), and an
aspirator bulb with drain valve (3) to the pressure connector (4).
 Select the Calibration test field.
 Set the following pressures in turn using the aspirator bulb and drain
valve on the reference meter.
– Reference meter: 250 mmHg/±3 mmHg
– Reference meter: 200 mmHg/±3 mmHg
– Reference meter: 150 mmHg/±3 mmHg
– Reference meter: 100 mmHg/±3 mmHg
– Reference meter: 50 mmHg/±3 mmHg

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 Wait until the value has stabilized for each pressure setting.
 Check each pressure setting in the Current test pressure display.
Target value for BPM: Display of reference meter (±3 mmHg)
 Remove the rigid metal vessel (1), the reference meter (2) and the
aspirator bulb with drain valve (3).
 Connect the pressure tubing to the BPM (option).
 Connect the blood pressure cuff to the pressure tubing.

Re: 9.1.5 Safety valve of BPM (option) checked.

Operating state: Standby
 Wrap the blood pressure cuff around a rigid metal vessel.
 In the OPTIONS menu, select the BPM field.
 Additionally with BPM version 1:
Select the Preselected pressure field and set the value 290 mmHg.
 Select the Bld. press. field.
The cuff is inflated up to the set value.
 When the cuff is fully inflated, squeeze it hard.
The cuff pressure exceeds the set value.
 Check that the safety valve opens to relieve the pressure.
Target value: The cuff deflates when the safety valve is opened.
BPM version 1:
After one measurement the device shows the following message: BPM:
Maximum cuff pressure exceeded. – Confirm
BPM version 2:
After three measurements, the device shows the following message:
BPM: Maximum cuff pressure exceeded. – Confirm

Re: 9.1.6 Blood pressure measurement performed with the BPM (option).
Operating state: Standby
 In the OPTIONS menu, select the BPM field.
 Additionally with BPM version 1:
Select the Preselected pressure field and set the value 160 mmHg.
 Wrap the blood pressure cuff around your arm.
 Select the Bld. press. field.
The blood pressure is measured.
 After the measurement, check whether the values are plausible.
Target value: The measured values are plausible.

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 Chapter 6: Technical safety checks / maintenance procedures

Re: 9.2 BTM (option): There are no additional technical safety checks and
maintenance procedures to be performed (exception:
measurement of the protective earth resistance).

Re: 9.3 BVM (option): There are no additional technical safety checks and
maintenance procedures to be performed (exception:
measurement of the protective earth resistance).

Re: 10 Error memory

Re: 10.1 Save and erase error memory.

Operating state: Service, CALIBRATE
 Create connection between PC Service Software and the device
with read and write authorizations (see chapter 5.5.2 on page 135).
 Back up the error memory of the device using the PC Service
Software.
 Erase the error memory of the device using the PC Service
Software.

Re: 11 Electrical safety check according to (DIN) EN 62353:2015,

IEC 62353:2014, and functional test

Re: 11.1 Protective earth resistance measured and checked.

Operating state: Off
 Remove any external test equipment.
 Connect the dialyzer couplings to the shunt interlock.
 Close the shunt interlock.
 Unplug the power plug of the device.
 Plug the test equipment for the electrical safety check into the AC
power supply.
 Plug the power plug of the device into the test equipment for the
electrical safety check.
 Make sure the power switch on the rear of the device is switched on.
 Set the test equipment for the electrical safety check to the mode for
measuring the protective earth resistance.
 Check the protective earth resistance at the following measurement
points.
Target value: ≤ 0.3 Ω with power supply cord
A test current between 200 mA and 1 A is recommended for measuring
the protective earth resistance so that interruptions or unstable
connections (loose contacts) can be detected clearly. Using a higher
test current may have a welding effect and, as a result, make unstable
connections appear to be good connections.

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Fig.: Measurement point – power supply unit (PSU housing) (1)

Fig.: Measurement point – shunt interlock flap (2)

Fig.: Measurement points – lower part of rear

– Heater rod chamber (3)
– Equipotential bonding connection (4)

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Fig.: Measurement points – EBM pumps (5) (e.g., substituate pump)

– Blood pump
– Substituate pump

Fig.: Measurement points – cassette positioning pin and door lock

– Cassette positioning pin (right) (6)
– Door lock (7)

 Measure the protective earth resistances at the following points on

the EBM using a test current of 200 mA:
– Cassette positioning pin (right) (6)
– Door lock (7)
This is necessary to avoid scorch marks and damage.

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Fig.: Door (non-anodized hole) (8)

 Remove the screw protection cap.

 Measure the protective earth resistance on the door (non-anodized
hole) (8) using a test current of 200 mA.
This is necessary to avoid scorch marks and damage.
 Insert the new screw protection cap.

Fig.: Measurement points – BTM (option)

– Arterial measuring head (9)
– Venous measuring head (10)

10

 Measure the protective earth resistances at the following points on

the BTM (option) using a test current of 200 mA:
– Arterial measuring head (9)
– Venous measuring head (10)
This is necessary to avoid scorch marks and damage.

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Fig.: Measurement point – BVM (option) (11)

11

 Measure the protective earth resistance on the BVM (11) (option)

using a test current of 200 mA.
This is necessary to avoid scorch marks and damage.

Re: 11.2 T1 test completed successfully.

Operating state: T1 test
 Set the test equipment for the electrical safety check to the mode for
measuring equipment leakage currents.
 Switch the device on.
 Start the T1 test.
 Leave dialyzer couplings in the shunt interlock.

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Re: 11.3 Pressure displays

Re 11.3.1 / 11.3.2 / 11.3.3 Zero point of pressure displays checked.

Operating state: T1 test or Preparation

1
2
3

 Leave dialyzer couplings in the shunt interlock.

 Insert a dry cassette system as shown.
 Remove all caps from the cassette system.
 Tighten the arterial and venous patient connections on the rinse
connector.
 Connect the rinse connector to the rinse port (1) and close the rinse
port (1).
 Close the arterial insertion site (2).
 Close the door.
 In the BLOOD SYSTEM menu, select the Lock door field.
The door is locked and the cassette system is connected.
 Connect the venous dialyzer connector to the reference meter (3)
using the long tube adapter (4).
 Make sure the arterial dialyzer connector (5) is open to atmosphere.
 Check the status display of the cassette coupling sensor in the EBM
Flow Diagram.
Target value: Status indicator lights up green.
 Wait five seconds. This ensures that enough measurements are
available for the averaged values.
 Check the arterial pressure in the EBM Flow Diagram.
Target value: 0 mmHg ±5 mmHg
 Check the venous pressure in the EBM Flow Diagram.

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Target value: 0 mmHg ±5 mmHg

 Check the pre-filter pressure in the EBM Flow Diagram.
Target value: 0 mmHg ±5 mmHg

Re 11.3.4 / 11.3.5 / 11.3.6 Slope of pressure displays checked.

Operating state: T1 test or Preparation

 Leave dialyzer couplings in the shunt interlock.

 Connect a syringe filled with air (1) to the venous insertion line.
 Open the arterial insertion site (2).
 Connect the arterial dialyzer connector to the arterial insertion site
(2) using the short tube adapter (3).
 Use the syringe to build up a pressure of approximately 280 mmHg.
 Wait until the value has stabilized.
 Check the arterial pressure in the EBM Flow Diagram.
Target value: built-up pressure ±10 mmHg
 Check the venous pressure in the EBM Flow Diagram.
Target value: built-up pressure ±10 mmHg
 Check the pre-filter pressure in the EBM Flow Diagram.
Target value: built-up pressure ±15 mmHg
Example with ±10 mmHg:
Built-up pressure: 283 mmHg
Target value: 273 mmHg to 293 mmHg
Example with ±15 mmHg:
Built-up pressure: 283 mmHg
Target value: 268 mmHg to 298 mmHg

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Re: 11.3.7 Venous occlusion clamp checked.

Operating state: T1 test or Preparation

1
2
3

 Leave dialyzer couplings in the shunt interlock.

 Insert the venous line (1) in the venous occlusion clamp.
 Remove the short tube adapter from the arterial insertion site (2) and
the arterial dialyzer connector (3).
 Close the arterial insertion site (2).
 Use the syringe to build up a pressure of approximately 280 mmHg.
 Leave the cassette system in the closed venous occlusion clamp for
at least 1 minute at a temperature of approximately 20 °C.
Pressure build-up – arterial side:
 Open the venous occlusion clamp manually, and hold it open.
 Wait until the value has stabilized.
 Check and record the arterial pressure in the EBM Flow Diagram.
Target value: 50 mmHg to 150 mmHg
 Release the venous occlusion clamp.
The venous occlusion clamp closes.
Pressure build-up – venous side:
 Use the syringe to build up a pressure of 1875 mmHg to
2025 mmHg.
 Wait until the value has stabilized.
 Record the value of the external reference meter.
 Wait 3 minutes.
After 3 minutes:
 Check the arterial pressure in the EBM Flow Diagram.

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Target value: recorded value of arterial pressure ±5 mmHg

 Check the value of the external reference meter.
Target value: value recorded by external reference meter –75 mmHg
 Remove the rinse connector from the rinse port.
 Close the rinse port.
 In the BLOOD SYSTEM menu, select the Remove lines field.
 Remove the cassette system.
 Perform additional checks only after completion of the T1 test.

Re: 11.4 Applied part type: type B

Device leakage currents for Type B applied part measured, scaled
to nominal line voltage, and checked taking the “Additional
condition” into account.
Operating state: Preparation
Requirements:
– Protective earth resistance measured and checked.
– Device is at operating temperature.
– Dialysate temperature: ≥ 36 °C
– Dialysate flow: ≥ 300 ml/min
– Dialysate conductivity: ≥ 13 mS/cm
Additional requirements for direct measurement according to figure 7:
– The device must be isolated from earth during the measurement.
– All external lines must be disconnected from the device.
– Do not touch the device while the measurement is in progress.
 Remove any external test equipment.
 Connect the dialyzer couplings to the shunt interlock.
 Close the shunt interlock.

Fig.: Differential current measurement according to figure 8

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Fig.: Direct measurement according to figure 7

 Set up the device for differential current measurement according to

figure 8 or for direct measurement according to figure 7.
 Record the nominal voltage of the power supply (U0).

AC polarity L – N:
 Measure and record the maximum device leakage current (IBmax).
 Measure and record the actual line voltage (UBmax).
 Scale the measured device leakage current value to the nominal line
voltage and record it (IN).
Formula: IN = (U0 x IBmax): UBmax
 Check the scaled device leakage current (IN), taking the "Additional
condition" (see Additional condition on page 202) into account.
Target value: IN ≤ 500 μA

AC polarity N – L:
 Change AC polarity (from L – N to N – L).
 Measure and record the maximum device leakage current (IBmax).
 Measure and record the actual line voltage (UBmax).
 Scale the measured device leakage current value to the nominal line
voltage and record it (IN).
Formula: IN = (U0 x IBmax): UBmax
 Check the scaled device leakage current (IN), taking the "Additional
condition" (see Additional condition on page 202) into account.
Target value: IN ≤ 500 μA

Additional condition If either of the scaled device leakage current values (IN) is higher than
450 μA, the last scaled device leakage current values (IN–1) must
additionally be considered for the rating.
 Find out the last scaled device leakage currents (IN–1).
 Calculate and check the device leakage currents taking the
"Additional condition" into account (IA).
Formula: IA = IN + (IN – IN–1)
Target value: IA ≤ 500 μA

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Examples – Example of a successful measurement:

Nominal voltage of the power supply (U0) 230 V

Maximum device leakage current (IBmax) 180 μA

Actual line voltage measured (UBmax) 225 V

Scaled device leakage current (IN) 184 μA

IN = (U0 × IBmax): UBmax
IN = (230 V × 180 μA): 225 V

Target value: IN = 184 μA ≤ 500 μA? Value OK

Additional condition: IN = 184 μA < 450 μA? Value OK

Measurement result: Measurement passed

– Example of a successful measurement taking last scaled device

leakage currents into account:

Nominal voltage of the power supply (U0) 230 V

Maximum device leakage current (IBmax) 474 μA

Actual line voltage measured (UBmax) 232 V

Scaled device leakage current (IN) 470 μA

IN = (U0 × IBmax): UBmax
IN = (230 V × 474 μA): 232 V

Target value: IN = 470 μA ≤ 500 μA? Value OK

Additional condition: IN = 470 μA < 450 μA? Value not OK

Take last scaled device leakage currents (IN–1) into account.

Last scaled device leakage current (IN–1) 450 μA

Device leakage current according to "Additional 490 μA

condition" (IA)
IA = IN + (IN – IN–1)
IA = 470 μA + (470 μA – 450 μA) = 490 μA

Target value: IA = 490 μA ≤ 500 μA? Value OK

Measurement result: Measurement passed

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– Example of a failed measurement:

Nominal voltage of the power supply (U0) 230 V

Maximum device leakage current (IBmax) 474 μA

Actual line voltage measured (UBmax) 232 V

Scaled device leakage current (IN) 470 μA

IN = (U0 × IBmax): UBmax
IN = (230 V × 474 μA): 232 V

Target value: IN = 470 μA ≤ 500 μA? Value OK

Additional condition: IN = 470 μA < 450 μA? Value not OK

Take last scaled device leakage currents (IN–1) into account.

Last scaled device leakage current (IN–1) 390 μA

Device leakage current according to "Additional 550 μA

condition" (IA)
IA = IN + (IN – IN–1)
IA = 470 μA + (470 μA – 390 μA) = 550 μA

Target value: IA = 550 μA ≤ 500 μA? Value not OK

Measurement result: Measurement failed

Re: 12 Final tasks

Re: 12.1 Disinfection program with Puristeril 340, Puristeril plus, Diasteril,
or Citrosteril started. Disinfectant drawn in.
Operating state: Cleaning
 Start disinfection program with Puristeril 340, Puristeril plus,
Diasteril, or Citrosteril.
 Ensure that the disinfectant was drawn in.

Re: 12.2 During disinfection: Power failure alarm checked.

Audible alarm, message: Power failure Device is battery-operated.
– Confirm.
Operating state: Cleaning
Requirement: alarm-free state
 Unplug the power plug.
 Check the audible alarm and the operating status indicator.
 Check the message.
 Reconnect the power plug.
The disinfection program will be continued.

Re: 12.3 Procedure recorded on the machine card and in the Medical
Device Register.
Operating state: Cleaning
 Record the procedure on the machine card.
 Record the procedure in the Medical Device Register.

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Re: 12.4 All waste properly disposed of.

Operating state: Cleaning
 Make sure all waste is properly disposed of.

Re: 12.5 All documents created.

Operating state: Cleaning
 Complete all the required documents.
 If the local service support organization has implemented a service
database, record the following items in the service report:
– Current operating hours
– Correct job code
– Test equipment used
– Values for electrical safety check
– E-code
– S-code
– Action performed
– Parts used

Re: 12.6 Only with USER SETUP  Cleaning  Check for residual
disinfectant = Manual and disinfection program with Puristeril 340,
Puristeril plus or Diasteril:
Disinfection program completed successfully. Absence of
residual disinfectant verified by means of test strips after
disinfection program.
Operating state: Standby
 Wait until the cleaning program has been completed successfully.
 Check absence of residual disinfectant by means of test strips (not
for Citrosteril).

Confirmation of the
inspection

Test equipment used (type  Record the type and serial number of all the test equipment used.
and serial number)

Inspection comments  Record any irregularities encountered during the inspection.

Date of inspection, tester's  Confirm the inspection by adding the date as well as the tester’s
signature and name signature and name.
The tester’s name can be replaced by a stamp required by the country
in question.

Assessment of the
inspection

The device is released for its There must be no risk to patients, staff or third parties during the
intended use intended use of the device.
 Make a definite decision as to whether or not the device can
continue to be used.
 Record this decision by marking Yes or No.

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 Depending on your decision, affix the inspection label to the device.

 Inform the responsible organization of any defects of the device
without delay.

Date of next inspection  Record the next test date, taking the intervals specified by the
manufacturer into account.

Assessment comments  Record any irregularities encountered during the assessment.

Date of assessment,  Confirm the assessment by adding the date as well as the signature
signature and name of and name of the representative of the responsible organization.
representative of the
The name of the representative of the responsible organization can be
responsible organization
replaced by a stamp required by the country in question.

6.5 TSC report

TSC/MA report TSC report The TSC/MA report (see TSC/MA report on page 140) and the TSC
report (see TSC report on page 207) differ in the following points:
– Maintenance procedures (MAs)
– Category TSC or MA in first column

Explanatory notes for The explanatory notes for completing the report are in a separate
completing the report chapter (see chapter 6.4 on page 144).

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TSC report 6008

Customer number/customer name: Inventory number:
Tester's name: Operating hours:
Software version: Equipment code:
Service report number: Serial number:
No. Designation Operating Measured /NA
state value/correction
Information:  = successful inspection item. NA = non-applicable inspection item.
1 Checks/procedures with device switched off and power plug unplugged
1.1 Power supply cord checked for signs of damage. Off – 
1.2 Checked that the fuse accessible on the outside has the correct rating. If present, Off – 
checked seal for damage.
1.3 Checked that all labels and inscriptions are present and legible. Off – 
1.4 Device checked for damage and dirt. Off – 
Target value: The mechanical condition of the device allows further safe use as
intended.
1.5 Hand crank for manual reinfusion present on device rear. Off – 
2 Check, clean, change components
2.5 Rinse port lip seal greased and replaced. Off – 
2.7 Rotors dismantled and cleaned. Off – 
2.8 Hydrophobic filter F42 with O-ring replaced. Off – 
Air feeding unit checked for fluid ingress.
2.10 Screws on blood and substituate pump drives tightened (230 Ncm). Off – 
2.12 Cassette contact mat and frame replaced. Off – 
2.14 Interval: Replace every six years. Off – 
Tubing in substituate valve (V31) replaced. New tube shortened to 70 mm in total. Tube
clip fitted according to angled nozzle used.
2.15 Filter F06 replaced. Off – 
2.16 Leakage sensors (EBM, S35) inspected visually. Leakage sensors cleaned. Off – 
2.18 Check valve for water inlet (A05) checked for proper function. Off – 
5 Blood leak detector
Information: Connect the power plug and switch the device on.
5.1 Blood leak detector checked. Service, 
Target value for blood leak voltage: 4.8 Volt to 5.2 Volt CALIBRATE / Volt
Target value for dimness voltage: 4.7 Volt to 5.3 Volt / Volt
6 Temperature/conductivity
Information: Device set up for verifying temperature and conductivity.
– Close the shunt interlock – no bypass
– Dialysate flow: 500 ml/min
– Dialysate temperature: 36.8 °C to 37.2 °C
– Conductivity: 13.5 mS/cm to 14.5 mS/cm
6.1 Temperature tested with reference meter. Service, 
Display of temperature sensor PT7 CALIBRATE / °C
Display of reference meter / °C
Target value for temperature difference (reference meter – PT7): –0.5 °C to +0.2 °C / °C
6.2 Conductivity tested with reference meter. If a bibag is generally used, the test must be Service, 
performed with a bibag. CALIBRATE
Display of conductivity sensor CD7 / mS/cm
Display of reference meter / mS/cm
Target value for conductivity difference (reference meter – CD7): ±0.15 mS/cm / mS/cm
7 OCM
7.1 Conductivity difference between CD7 and CD9 checked. Service, 
Target value for conductivity difference (CD7 – CD9): ±0.05 mS/cm CALIBRATE / mS/cm
If the conductivity difference is > ±0.05 mS/cm: Calibrate conductivity and OCM.
8 Extracorporeal components
8.1 Cassette sensors calibrated. Service, – 
CALIBRATE
8.2 Function of substituate unit checked. Service, – 
DIAGNOSTI
CS
8.3 Function of Blood System Stop button checked. Service, – 
DIAGNOSTI
CS

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Service report number: Serial number:

No. Designation Operating Measured /NA
state value/correction
9 Options
9.1 BPM (option): The technical measurement checks (TMCs) additionally required are country-specific and form part of the  /
technical safety checks (TSCs).
9.1.3 BPM (option) checked for leaks. Service, / mmHg/ 
Target value Maximum leakage rate: ≤ 6 mmHg/min DIAGNOSTI min
CS
9.1.4 BPM (option) checked against the required pressures. Service, 
Reference meter: +250 mmHg (±3 mmHg) DIAGNOSTI / mmHg
CS
Target value for BPM: Display of reference meter (±3 mmHg) / mmHg
Reference meter: +200 mmHg (±3 mmHg) / mmHg
Target value for BPM: Display of reference meter (±3 mmHg) / mmHg
Reference meter: +150 mmHg (±3 mmHg) / mmHg
Target value for BPM: Display of reference meter (±3 mmHg) / mmHg
Reference meter: +100 mmHg (±3 mmHg) / mmHg
Target value for BPM: Display of reference meter (±3 mmHg) / mmHg
Reference meter: +50 mmHg (±3 mmHg) / mmHg
Target value for BPM: Display of reference meter (±3 mmHg) / mmHg
9.1.5 Safety valve of BPM (option) checked. Standby – 
Target value: The cuff deflates when the safety valve is opened.
9.1.6 Blood pressure measurement performed with the BPM (option). Standby – 
Target value: The measured values are plausible.
9.2 BTM (option): There are no additional technical safety checks and maintenance procedures to be performed (exception: measurement
of the protective earth resistance).
9.3 BVM (option): There are no additional technical safety checks and maintenance procedures to be performed (exception: measurement
of the protective earth resistance).
11 Electrical safety check according to (DIN) EN 62353:2015, IEC 62353:2014, and functional test
Information: Switch off the device.
11.1 Protective earth resistance measured and checked. Off / Ω 
Target value: ≤ 0.3 Ω with power supply cord
Information: Switch the device on. Prepare and fill in service report and documents.
11.2 T1 test completed successfully. T1 test – 
11.3 Pressure displays
11.3.1 Zero point of arterial pressure display checked. T1 test, EBM / mmHg 
Target value: 0 mmHg ±5 mmHg Flow
Diagram
11.3.2 Zero point of venous pressure display checked. T1 test, EBM / mmHg 
Target value: 0 mmHg ±5 mmHg Flow
Diagram
11.3.3 Zero point of pre-filter pressure display checked. T1 test, EBM / mmHg 
Target value: 0 mmHg ±5 mmHg Flow
Diagram
11.3.4 Check the slope of the arterial pressure display with a built-up pressure of T1 test, EBM / mmHg 
approximately 280 mmHg. Flow
Target value: built-up pressure ±10 mmHg Diagram
11.3.5 Check the slope of the venous pressure display with a built-up pressure of T1 test, EBM / mmHg 
approximately 280 mmHg. Flow
Target value: built-up pressure ±10 mmHg Diagram
11.3.6 Slope of the pre-filter pressure display checked with a built-up pressure of approx. T1 test, EBM / mmHg 
280 mmHg. Flow
Target value: built-up pressure ±15 mmHg Diagram
11.3.7 Venous occlusion clamp checked. T1 test, EBM / mmHg 
A change in pressure must not exceed the following values within 3 minutes: Flow
Arterial pressure display, maximum change in pressure: ±5 mmHg Diagram
Pressure display of reference meter, maximum pressure drop: –75 mmHg

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Service report number: Serial number:

No. Designation Operating Measured /NA
state value/correction
11.4 Applied part type: type B Preparation 
Device leakage currents of applied part type B measured, measurement value scaled
to nominal line voltage and checked against "Additional condition".
Target value: IN ≤ 500 μA
 Differential current measurement according to figure 8
 Direct measurement according to figure 7
Nominal voltage of the power supply (U0) V
AC polarity L – N:
Maximum device leakage current (IBmax) / μA
Actual line voltage measured (UBmax) / V
Device leakage current scaled to nominal line voltage (IN = (U0 × IBmax): UBmax) / μA
AC polarity N – L:
Maximum device leakage current (IBmax) / μA
Actual line voltage measured (UBmax) / V
Device leakage current scaled to nominal line voltage (IN = (U0 × IBmax): UBmax) / μA
12 Final tasks
12.1 Disinfection program with Puristeril 340, Puristeril plus, Diasteril, or Citrosteril started. Cleaning – 
Disinfectant drawn in.
12.2 During disinfection: Power failure alarm checked. Cleaning – 
Audible alarm, message: Power failure Device is battery-operated. – Confirm
12.3 Procedure recorded on the machine card and in the Medical Device Register. Cleaning –  /
12.4 All waste properly disposed of. Cleaning – 
12.5 All documents created. Cleaning – 
12.6 Only with USER SETUP  Cleaning  Check for residual disinfectant = Manual and Standby –  /
disinfection program with Puristeril 340, Puristeril plus or Diasteril:
Disinfection program completed successfully. Absence of residual disinfectant verified
by means of test strips after disinfection program.
Confirmation of the inspection
Service report number: Serial number:
Test equipment used (type and serial number):

Inspection comments:

Date of inspection: Tester's signature: Tester's name:

#FMESIG_5##

Assessment of the inspection

The device is released for its intended use.  Yes  No Date of next inspection:
The inspection label has been attached to the device.
Comments on the assessment:

Date of assessment: Signature of representative of the responsible Name of representative of the responsible
organization: organization:

#FMESIG_6##

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7 Messages
Device messages can be "parked" in the status bar
(Alarm/Warning/Info) and viewed when necessary.

1
To display a parked message:
 Select the field (1) in the status bar.
The message with the highest priority will be
displayed.

To park a message in the status bar:

 Select the field (2) for the message.
The message will be parked in the status bar.

2 To display the help text for a message:

3  Select the field (3).
4
The message help text will be shown in the
5 Info field (4).

Message number The message number (5) unambiguously identifies the message.
Further information on the message number can be obtained from the
responsible local service support organization.

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8 Test equipment and tools

We recommend using the UMED II or UMED measuring instrument that
can be obtained from the manufacturer.
The precision of the measuring instrument used during calibration is
important for the accuracy of the OCM measurement. The measuring
instrument used to calibrate the conductivity must have an accuracy of
±0.05 mS/cm at temperatures from 35 °C to 39 °C.

Note
Incorrect measurement result due to incorrect operation of test
equipment
 Follow the Instructions for Use for all test equipment.

HMED UMED tubing set

The HMED UMED tubing set consists of the
following components:
– Luer lock connector with red clamp and
connected hydrophobic filter
– Luer lock connector with blue clamp and
connected hydrophobic filter
– Luer lock connector with distance marking

Pressure measuring instrument HMED with

case (set)

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Universal measuring device UMED II

(conductivity, pressure, temperature)

Universal measuring device UMED with case

(set) (conductivity, pressure, temperature)
External pressure sensor EPS

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 Chapter 8: Test equipment and tools

Power supply cable 5008 UMED

Short tube adapter

Long tube adapter

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Chapter 8: Test equipment and tools

Secutest for testing electrical safety (without

printer module)
Printer module
Carrying case (not shown)

PC Service Software service program

ESD service kit

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 Chapter 8: Test equipment and tools

ESD workshop kit

Torque wrench 20 to 120 Ncm

Torque wrench 100 to 500 Ncm

Short-shank Allen wrench for the guide bolt in

the pressure actuator

Mounting aid for the supports of the cassette

contact mat

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Chapter 8: Test equipment and tools

Removal tool for O-rings

Closing plugs for hydraulic ports

Loctite 243 threadlocker

MOLYKOTE LONGTERM W2 grease

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POLYLUB GLY151 grease

UNISILKON L 250 L grease

BARRIERTA L55/1 grease

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A tilting tool is available for laying the device

on its back.
Using the tilting tool, the device can be laid on
its back for repair purposes.
 Assemble the parts according to the
accompanying instructions.
Included parts:
1 Housing (for all devices)
2 Trolley (only for 5008S and 6008)
3 Trolley (only for 5008)
4 Extractable concentrate rack
(only for 5008)

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9 Calibration/Adjustment

9.1 SERVICE menu

SERVICE menu

Flow diagram menu Parameters (see chapter 9.2 on page 222)

CALIBRATE menu Parameters (see chapter 9.4 on page 228)

DIAGNOSTICS menu Parameters (see chapter 9.5 on page 240)

SETUP menu Parameters (see chapter 5.2 on page 94)

MODULE menu Parameters (see chapter 9.7 on page 250)

VARIOUS menu Parameters (see chapter 9.8 on page 251)

UPDATE menu Parameters (see chapter 9.9 on page 251)

 Selecting the SERVICE menu

Device is switched on and the T1 test of the EBM has been performed.
 Insert the ServiceCard.

Note
No access rights due to invalid ServiceCard
After successfully completing the appropriate training for the 6008
device, an expiry date is explicitly set for this device on the ServiceCard.
When the expiry date of the ServiceCard has been exceeded, the
following message is issued when the ServiceCard is inserted: Card not
valid, as expiry date has been exceeded. – OK
 When the expiry date has been exceeded, select the OK field and
have the expiry date of the ServiceCard extended.

 Select the SYSTEM menu.

 In the SYSTEM menu, select the SERVICE field.
Message: Remove ServiceCard!
 Remove the ServiceCard.
 In the SERVICE menu, select the required field.

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9.2 Flow diagram menu

The flow diagram shows the current states and values relating to the
current device features.
Values for the hydraulics:
– Max. water inflow [ml/min]
– Flow [ml/min]
– Heater power [%]
– Pressure [mbar] of S03, S07, S15, and S16
– Conductivity [mS/cm] of CD4, CD5, CD7, and CD9
– Temperature [°C] of PT2, PT4, PT5, PT7, PT8, and PT9
Values for the extracorporeal blood circuit module:
– Pressure [mmHg] of Pven and PPre

9.2.1 Setting the maximum water inflow

Requirements The dialysis water inlet pressure and the dialysis water inlet rate are
subject to changes if more devices than one are operated on one
reverse osmosis unit. The maximum water inflow (Max. water inflow)
should therefore be checked and set under ordinary treatment
conditions. This means, for example, that if an average of 30 devices
are used for treatment in normal operation, the reverse osmosis unit
should also be loaded with 30 devices.
– Observe environmental conditions.
– Make sure the reverse osmosis unit is running under its normal load.

Tip
If water deficiency alarms occur sporadically, the maximum water inflow
should be checked with the following loads on the reverse osmosis unit.
In each case, the maximum water inflow should be within the limits
specified.
Low load: Load the reverse osmosis unit with approx. every sixth
device.
Medium load: Load the reverse osmosis unit with approx. every
second device.
Maximum load: Load the reverse osmosis unit with all devices.

Calibration  Select the SERVICE menu.

 Select the CALIBRATE menu.
The hydraulics are working.
 Select the field in the status bar to display the animated flow
diagram.
By repeatedly selecting the field, it is possible to switch between
the EBM Flow Diagram and the Flow diagram.

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Note
Incorrect maximum water inflow value due to water deficiency
alarm
In the event of a water deficiency alarm, the flow diagram shows the
previously measured value of the Max. water inflow in red.
 Correct the water deficiency alarm.

Note
A dialysate flow of 1000 ml/min cannot be reliably achieved due to
insufficient water inflow
If the maximum water inflow is less than 1300 ml/min, a dialysate flow
of 1000 ml/min cannot be reliably achieved.
 Set the maximum water inflow to ≥ 1300 ml/min.

Note
Water deficiency alarm associated with widely fluctuating dialysis
water inlet pressure
A widely fluctuating dialysis water inlet pressure can lead to a water
deficiency alarm.
 The maximum water inflow should preferably be accomplished with
a dialysis water inlet pressure of 2.5 to 4.0 bar.
 The maximum water inflow can, in exceptional cases, be set to a
value up to 1800 ml/min with a dialysis water inlet pressure of 2.5 to
4.0 bar.
Exceeding the target value of 1300 ml/min to 1550 ml/min may cause
other devices to experience water deficiency problems.

 Read the Max. water inflow [ml/min] value in the animated flow
diagram.
 Pull out the adjustment knob (1) of the pressure reducing valve A04.

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 Adjust the pressure reducing valve A04.

– Increase (+) the maximum water inflow: In the clockwise direction
– Reduce (–) the maximum water inflow: In the counterclockwise
direction
 Push in the adjustment knob (1) of the pressure reducing valve A04.
 Wait at least one minute until the value has stabilized.
 Check the Max. water inflow [ml/min] value in the animated flow
diagram.
Target value: 1300 ml/min to 1550 ml/min
 Correct the maximum water inflow again, if necessary.

9.3 EBM Flow Diagram

Select EBM Flow Diagram  Select the field in the status bar to have the EBM Flow Diagram
displayed.
By repeatedly selecting the field, it is possible to switch between
the EBM Flow Diagram and the Flow diagram.

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9.3.1 EBM Flow Diagram without Single-Needle (option)

22
8 21

7 19

42

6 43
40
37
9
10 18 34 32
11
20 33
41
3
39
16
2 17
30
38
36 31 29
35
15
1
14

4 47
26 28
53 51 48 49
5 52
25 27 50
12 13

46
44 45
55 23 24

Legend
1 Flow rate, blood pump 36 Status, vacuum coupling valve
2 Status, blood pump 37 Status, pressure valve
3 Status, Hall sensor, rotor, blood pump 38 Status, hydraulic coupling valve
4 Status, Hall sensor, disk1, blood pump 39 Status, “VUnlock”
5 Status, Hall sensor, disk2, blood pump 40 Status, door detector
6 Flow rate, substituate pump 41 Status, cassette detection sensor 2
7 Status, substituate pump 42 Status, cassette detection sensor 1
8 Hall sensor, rotor, substituate pump 43 Status, substituate unit
9 Hall sensor, disk1, substituate pump 44 Status, substituate unit
10 Hall sensor, disk2, substituate pump 45 Status, rinse port
11 Status, rotor brake 46 Status, leakage sensor
12 Heparin delivery rate 47 Status, V31, hydraulics
13 Status, heparin syringe 48 Status, V32, hydraulics
14 Arterial fistula pressure 49 Status, V33, hydraulics
15 Venous fistula pressure 50 Status, hydraulics coupling valve, hydraulics
16 Pre-filter pressure 51 Status, V42, hydraulics
17 Status, level detector 52 Status, V43, hydraulics
18 Status, predilution valve 53 Dialysate pressure (S03), hydraulics
19 Status, postdilution valve 54 Temperature, actuator-sensor board
20 Status, SN valve 55 Length sensor, heparin pump
21 Status, valve for venous insertion site
22 Status, air separation valve
23 Status, arterial occlusion clamp
24 Status, venous occlusion clamp
25 Status, arterial ABD
26 Status, arterial OD
27 Status, venous ABD
28 Status, venous OD
29 Status, system compressor
30 Status, positive pressure valve
31 Status, negative pressure valve
32 Positive pneumatic pressure
33 Negative pneumatic pressure
34 Differential pneumatic pressure
35 Status, cassette coupling sensor

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9.3.2 EBM Flow Diagram with Single-Needle (option)

58

22
8 21

7 19

42
61 59 60 62 64 63
56
6 43
40
37
57
9
10 18 34 32
11
20 33
41
3
39
16
2 17
30
38
36 31 29
35
15
1
14

4 47
26 28
53 51 48 49
5 52
25 27 50
12 13

46
44 45
55 23 24

Legend
1 Flow rate, blood pump 36 Status, vacuum coupling valve
2 Status, blood pump 37 Status, pressure valve
3 Status, Hall sensor, rotor, blood pump 38 Status, hydraulic coupling valve
4 Status, Hall sensor, disk1, blood pump 39 Status, “VUnlock”
5 Status, Hall sensor, disk2, blood pump 40 Status, door detector
6 Flow rate, substituate pump 41 Status, cassette detection sensor 2
7 Status, substituate pump 42 Status, cassette detection sensor 1
8 Hall sensor, rotor, substituate pump 43 Status, substituate unit
9 Hall sensor, disk1, substituate pump 44 Status, substituate unit
10 Hall sensor, disk2, substituate pump 45 Status, rinse port
11 Status, rotor brake 46 Status, leakage sensor
12 Heparin delivery rate 47 Status, V31, hydraulics
13 Status, heparin syringe 48 Status, V32, hydraulics
14 Arterial fistula pressure 49 Status, V33, hydraulics
15 Venous fistula pressure 50 Status, hydraulics coupling valve, hydraulics
16 Pre-filter pressure 51 Status, V42, hydraulics
17 Status, level detector 52 Status, V43, hydraulics
18 Status, predilution valve 53 Dialysate pressure (S03), hydraulics
19 Status, postdilution valve 54 Temperature, actuator-sensor board
20 Status, SN valve 55 Length sensor, heparin pump
21 Status, valve for venous insertion site 56 Single-Needle pressure
22 Status, air separation valve 57 Status, Single-Needle level detector
23 Status, arterial occlusion clamp 58 Status, Single-Needle compressor
24 Status, venous occlusion clamp 59 Status, Single-Needle bypass valve 1
25 Status, arterial ABD 60 Status, Single-Needle bypass valve 2
26 Status, arterial OD 61 Single-Needle line pressure
27 Status, venous ABD 62 Single-Needle tank pressure
28 Status, venous OD 63 Single-Needle absolute pressure
29 Status, system compressor 64 Single-Needle tank temperature
30 Status, positive pressure valve
31 Status, negative pressure valve
32 Positive pneumatic pressure
33 Negative pneumatic pressure
34 Differential pneumatic pressure
35 Status, cassette coupling sensor

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9.3.3 Description

(Color) Legend – All actuators and LEDs are drawn in gray or filled with gray color,
unless they are assigned a determined value.
– Values/texts will only be entered when a determined value is
available.
– The rotor brake is represented as an actuator, i.e., the piston is
shown in extended position when the rotor brake is activated.

Valves For valves, the condition (open/closed) is displayed:

– Closed = black
– Open = green

Compressors For compressors, the condition (off/on) is displayed:

– Off = black / white
– On = green

Hall sensors For Hall sensors, the switching condition is displayed:

– Off = white
– On = green

Level detectors For level detectors, the logical condition is displayed:

– No level detected = white
– Level detected = green
– Error = red

Optical detectors For optical detectors, the logical condition is displayed:

– No blood detected = white
– Blood detected = green
– Error = red

Air bubble detectors The air bubble detectors (ABDs) are shown in their logical state:
– Air detected = white
– No air detected = green
– Error = red

Cassette detection The cassette detection sensors are shown in their logical state:
sensors – Cassette not detected = white
– Cassette detected = green
– Error = red

Cassette coupling sensor The cassette coupling sensor is shown in its logical state:
– Vacuum not present = white
– Vacuum present = green
– Error = red

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9.4 CALIBRATE menu

CALIBRATE menu

Calibrate touch screen Parameters (see chapter 9.4.1 on page 228)

Pressure transducer (S03/S07/S15/S16) Parameters (see chapter 9.4.2 on page 229)

Degassing (A02/P01) Parameters (see chapter 9.4.3 on page 229)

Flow pump (P03/A03) Parameters (see chapter 9.4.4 on page 231)

Temperature (PT7/PT8/PT9) Parameters (see chapter 9.4.5 on page 232)

Conductivity (CD7/CD9) Parameters (see chapter 9.4.6 on page 233)

Volumes Parameters (see chapter 9.4.7 on page 234)

Blood leak Parameters (see chapter 9.4.8 on page 234)

OCM Parameters (see chapter 9.4.9 on page 235)

ECMP configuration Parameters (see chapter 9.4.10 on page 236)

Substituate unit Parameters (see chapter 9.4.11 on page 237)

Cassette sensors Parameters (see chapter 9.4.12 on page 238)

If a red "?" is shown in one of the fields, this indicates that no valid
calibration value is available.

9.4.1 Calibrate touch screen menu option

 Select the Calibrate touch screen field.

 Select the Start calibration field.
The following message will be displayed at the upper left: Touch the
target center spot!
 Touch the target center spot.
The following message will be displayed at the lower right: Touch the
target center spot!
 Touch the target center spot.
After calibration has been completed successfully, the CALIBRATE
menu is displayed.

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If the menu cannot be selected (touchscreen needs calibration), use the

following combination of buttons on the monitor:
 Consecutively press and hold the Audio Paused, Blood System
Start and Blood System Stop buttons until the target point appears
at the upper left of the screen.
Follow the steps above to continue calibration.

9.4.2 Pressure transducer (S03/S07/S15/S16) menu option

 Select the Pressure transducer (S03/S07/S15/S16) field.

 Select the Start calibration field.
Message: Please wait. Automatic calibration of S03/S07/S15/S16 in
progress. – Stop.
After successful calibration the following message will be displayed:
Check or recalibrate degassing (P01) and loading pressure (A02/A03)!
– Confirm.
 Select the Confirm field.
After calibration has been completed successfully, the CALIBRATE
menu is displayed.

9.4.3 Degassing (A02/P01) menu option

Requirement The pressure transducers (S03/S07/S15/S16) are calibrated.

A02

 Select the Degassing (A02/P01) field.

9.4.3.1 Loading pressure test menu sub-item

 Select the Loading pressure test field.

The loading pressure (A02) is determined.
Message: Loading pressure balancing chamber (A02) between 1800 -
1900 mbar Pressure: # mbar – Stop.

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9.4.3.2 Negative pressure test menu sub-item

 Select the Negative pressure test field.

The degassing pressure of the degassing pump is determined.
The following message will first be displayed: Please wait. Filling phase
in progress! – Stop.
The following message is then displayed: Degassing pressure: # mbar
– Stop.

9.4.3.3 Start calibration menu sub-item

 Select the Start calibration field.

Message: Please wait. Filling phase in progress! – Stop
Message: Please wait. Plausibility check S03/S07/S15/S16 in progress.
– Stop
Message: Adjustment of relief valve A02 between 1800 and 1900 mbar
Pressure: # mbar – Confirm – Stop.
 If the pressure value is within the defined range, select the Confirm
field.
If the pressure value is not within the defined range, the pressure must
be adjusted using A02.
 Set the pressure value using A02.
 Then select the Confirm field.
Message: Initial degassing pump test in progress.
Automatic calibration starts with the "initial degassing pump test"
(checking the status of the degassing pump).
Message: Please wait. Filling phase in progress! – Stop.
Message: Please wait. Automatic degassing calibration in progress.
Speed P01: # rpm Pressure S16: # mbar – Stop.
After automatic calibration has been completed, the following message
will be displayed: Adjustment of relief valve A02 between 1800 and
1900 mbar Pressure: # mbar – Confirm – Stop.
 If the pressure value is within the defined range, select the Confirm
field.
After calibration has been completed successfully, the CALIBRATE
menu is displayed.

9.4.3.4 Automatic calibration of the degassing pressure

Requirement Automatic calibration of the degassing pressure has to be activated in

the SETUP  Settings Hydraulics  Auto calibration  Degassing
(P01) menu.

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When the function has been activated, the device measures the
degassing pressure during every disinfection and saves the measured
value. When a disinfection is started, this value is compared with the
degassing pressure reached during the previous calibration.
If the two values differ too greatly or if there is a hydraulics test error,
then the degassing pressure is automatically calibrated at the start of a
disinfection program. The time-counting of the disinfection program is
paused during this procedure.
The following message is stored in the error memory after successful
calibration: Automatic calibration of P01 successful. New speed: ####
Negative pressure: # [mbar].
If the degassing cannot be calibrated automatically, the disinfection
program is continued with the original calibration values. If this is not
possible on multiple occasions, automatic calibration is deactivated and
the following message is displayed each time a disinfection is started:
Automatic device calibration not possible. Treatment can still be
performed with this device. Call service! – OK.

9.4.4 Flow pump (P03/A03) menu option

Requirement The pressure transducers (S03/S07/S15/S16) are calibrated.

A03

 Select the Flow pump (P03/A03) field.

 Select the Start calibration field.
Message: Adjustment of relief valve A03 between 2450 and 2650 mbar
Loading pressure: # mbar – Confirm – Stop.
 If the pressure value is within the defined range, select the Confirm
field.
After calibration has been completed successfully, the CALIBRATE
menu is displayed.
If the pressure value is not within the defined range, the pressure must
be readjusted using A03.
 Set the pressure value using A03.
 Then select the Confirm field.

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After calibration has been completed successfully, the CALIBRATE

menu is displayed.

Note
Dialysate flow problems due to unfavorable adjustment values
If the flow deviates from the selected dialysate flow by ±20 ml/min or
–10 %, the flow pump (P03) will adjust the dialysate flow automatically.
While the flow pump (P03) is adjusting the flow, it is shown in yellow in
the flow diagram. When the flow pump (P03) in the flow diagram is once
again displayed in red with yellow circles, this means a new adjustment
value has been set and stored.
 Allow each dialysate flow in turn to be adjusted from 100 ml/min to
1000 ml/min in 100 ml/min increments.
– Select the CALIBRATE menu.
– Set the Desired flow field.
– Select the Flow diagram field (waves).
– Ensure that the flow pump (P03) in the flow diagram continues to
be displayed in red with yellow circles over several balancing
chamber switching cycles.

9.4.5 Temperature (PT7/PT8/PT9) menu option

Note
It may not be possible to calibrate the temperature, e.g., if the
mandatory rinse or mandatory disinfection flag is set, water is not
supplied via the heat exchanger but via valve V38.
In such cases, it might not be possible to reach temperatures > 34 °C
with low water inlet temperatures, despite 100 % heater output.
 Clear the mandatory rinse or mandatory disinfection flag
(see chapter 9.7.1 on page 250).
 Calibrate the temperature.

Requirement The device must be closed.

Calibration  Select the Start calibration field.

 Attach a reference meter to the lowest point of the IV pole.
 Connect the dialyzer couplings to the reference meter.
 Switch on the flow and allow it to adjust for approx. 10 minutes.
 Wait until the temperature has decreased to a stable value.
 Measure the reference temperature with the reference meter.
 Select the Ref. temp. field.
 Enter the reference temperature.
 Confirm the entered value with the OK field.
 Select the Accept value field.

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After calibration has been completed successfully, the CALIBRATE

menu is displayed.

Note
After a recalibration of the temperature, the following steps must be
taken:
 Check Conductivity (CD7/CD9) and recalibrate if necessary.
 Recalibrate the OCM.

9.4.6 Conductivity (CD7/CD9) menu option

Requirements – The Temperature (PT7/PT8/PT9) is calibrated.

– The device must be closed.
– The connected concentrate is identical to the set concentrate.
– Flow on, response time approx. 10 minutes.
 Measure the reference conductivity with the external measuring
instrument and wait until the conductivity has reached a stable value.
 Select the Conductivity (CD7/CD9) field.
 Select the Start calibration field.
Automatic setting of Prescr. Na depending on the connected
concentrate.
 Select the Ref. CD 13.00 mS/cm field.
 Enter the stable reference conductivity.
 Confirm the entered value with the OK field.
 Select the Accept value field.
(If the reference CD cannot be entered, the CD can be adapted by
changing Prescr. Na.)
Automatic setting of Prescr. Na depending on the connected
concentrate.
 Select the Ref. CD 15.00 mS/cm field.
 Enter the stable reference conductivity.
 Confirm the entered value with the OK field.
 Select the Accept value field.
(If the reference CD cannot be entered, the CD can be adapted by
changing Prescr. Na.)
After calibration has been completed successfully, the CALIBRATE
menu is displayed.

Note
If conductivity has been recalibrated, OCM must also be recalibrated.

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9.4.7 Volumes menu option

 Select the Volumes field.

 Select the Start calibration field.
The following volumes will be displayed:
– Balancing chamber (volume evaluated for the flow)
– UF pump
The values displayed must match the values on the labels of the above
components.
 If the values displayed do not match, enter the values according to
the component labels and confirm.

9.4.8 Blood leak menu option

Requirements – The Temperature (PT7/PT8/PT9) is calibrated.

– Dialysate temperature: 34 °C to 39 °C.
– Flow on, flow 500 ml/min.
 Check the cuvette position in the blood leak detector (see
chapter 10.12.13 on page 427).
 Check that the cuvette is clean and clear.
 Close the device (avoid exposure to external light).
 Select the Blood leak field.
 Select the Start calibration field.
Message: Please confirm that the cuvette is clear and is inserted
correctly into the blood leak detector! Calibration will then be performed
automatically! – Confirm – Stop.
 Select the Confirm field.
After calibration has been completed successfully, the CALIBRATE
menu is displayed.

9.4.8.1 Automatic calibration of the blood leak voltage

Requirement Automatic calibration of the blood leak voltage has to be activated in the
SETUP  Settings Hydraulics  Auto calibration  Blood leak
menu.

Note
Incomplete calibration of the blood leak detector
The blood leak voltage is merely decreased (sensitivity is increased) by
the automatic calibration of the blood leak voltage, to ensure the safe
condition of the device.
The function does not calibrate the dimness voltage.
 Calibrate the blood leak detector completely.

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When the function has been activated, the device measures the blood
leak voltage at the beginning of the T1 test. This value is used to
determine whether the blood leak voltage needs to be calibrated.
If it does, the blood leak voltage is calibrated automatically before the
T1 test of the blood leak detector.
The following message is stored in the error memory after successful
calibration: Automatic calibration of blood leak voltage successful.
Previous value:### New value: ###.
If the blood leak voltage cannot be calibrated automatically, the T1 test
continues with the original calibration values, and the following
message is stored in the error memory: Automatic calibration of blood
leak voltage canceled. Calibration value:#### Error number: ##.

9.4.9 OCM menu option

Requirements – The Temperature (PT7/PT8/PT9) is calibrated.

– The Conductivity (CD7/CD9) is calibrated.

Note
Imprecise OCM calibration due to deposits in the hydraulics
 Ensure that a disinfection program was run before the OCM
calibration.

 Select the OCM field.

 Select the Start calibration field.
Message: OCM calibration in progress. Remaining time: approx. #
minutes – Stop
After successful calibration the following message will be displayed:
Correction factor: Up = #,#### Down = #,#### Cdi-Cdo-deviation = #
µS/cm – Confirm
 Select the Confirm field.
After calibration has been completed successfully, the CALIBRATE
menu is displayed.

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9.4.10 ECMP configuration menu option (eccentric membrane pumps)

PCB LP 1141-3
X_SPARE connector

PCB LP 1141-3 J3
jumper

Eccentric membrane pumps must be configured after being replaced.

The ultrafiltration pump (P04) can be replaced by an ultrafiltration pump
or by a universal eccentric membrane pump. The pump's contact plates
/ valve electrodes are required.
A concentrate pump (P06) or a bicarbonate pump (P05) can be
replaced by an ultrafiltration pump or by a universal eccentric
membrane pump. The pump's contact plates / valve electrodes are not
required.
 Select the ECMP configuration field.
 Select the Start field.
Message: Please connect the ECMP to be programmed to the ECMP
service plug and confirm. – Confirm – Stop.
 Connect the eccentric membrane pump to be configured to the
X_SPARE connector on PCB LP 1141-3.

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 Move jumper J3 on PCB LP 1141-3 from position 2/3 to 1/2.

 Select the Confirm field.
 Select the required pump.
 Select the Program field.
Only when the ultrafiltration pump (P04) is configured will the following
message be additionally displayed: Pump equipped with contact
sheets/valve electrodes? – Yes – Stop.
 Select the Yes field.
Message: Programming successfully completed. Please disconnect
the ECMP from its service plug and confirm. – Confirm.
 Remove the eccentric membrane pump from the X_SPARE
connector on PCB LP 1141-3.
 Move jumper J3 on PCB LP 1141-3 from position 1/2 to 2/3.
 Connect the eccentric membrane pump to the appropriate connector
X_SOD, X_BIC or X_UF on PCB LP 1141-3.
 Select the Confirm field.

9.4.11 Substituate unit menu option

Note
Defect in substituate unit due to incorrect calibration values
The substituate unit must not be activated until the correct calibration
values have been entered. This also applies if the calibration values of
the new substituate unit are identical to those of the old substituate unit.
 Open the door so the substituate unit cannot be activated.

 Select the Substituate unit field.

 Select the Start calibration field.

1
2
3

 Read the values off the substituate unit and enter:

– Swivel position (1)
– Rinse position (2)
– Connecting position (3)

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9.4.12 Cassette sensors menu option

This function is used to calibrate the following cassette sensors only

(the type of cassette system used does not matter):
– Cassette detection sensor 1
– Cassette detection sensor 2
– Cassette coupling sensor
No other sensors in the vicinity of the cassette contact mat are
calibrated using this function.

Requirement Cassette system not inserted.

 If the device is not switched on and negative pressure has not been
created, switch the device on and wait until the system compressor
is no longer active (see chapter 9.3 on page 224).
 Check that the pneumatics negative pressure (1) displayed in the
EBM Flow Diagram is stable.

 Ensure that the cassette contact mat is still correctly seated at the
marked positions after the negative pressure has been created.
Example pictures of improperly installed cassette contact mats (see
chapter 10.15.3 on page 484).
 Close the door.
 Check the Installation altitude field in the SETUP  Settings
Hydraulics menu.
 Select the Start calibration field in the CALIBRATE  Cassette
sensors menu.

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Cassette sensors are calibrated.

 Follow the on-screen instructions.
Message: Calibration of the cassette sensors was successfully
completed. – Confirm
 Select the Confirm field.
After calibration has been completed successfully, the CALIBRATE
menu is displayed.

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9.5 DIAGNOSTICS menu

DIAGNOSTICS menu

Monitor

Info Parameters (see chapter 9.5.1 on page 241)

EBM

Info Parameters (see chapter 9.5.2 on page 241)

Test Parameters (see chapter 9.5.3 on page 241)

Hydraulics

Info Parameters (see chapter 9.5.4 on page 245)

Flow diagram: Individual control Parameters (see chapter 9.5.5 on page 245)

Test Parameters (see chapter 9.5.6 on page 246)

Power supply unit

Info Parameters (see chapter 9.5.7 on page 247)

Radio (option)

Info Parameters (see chapter 9.5.8 on page 248)

BPM (option)

Info / Test Parameters (see chapter 9.5.9 on page 248)

BVM (option)

Info / Sensors Parameters (see chapter 9.5.10 on page 249)

BTM (option)

Info / Sensors Parameters (see chapter 9.5.11 on page 250)

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9.5.1 Monitor – Info menu option

The DIAGNOSTICS  Monitor  Info menu features the following

items:
– Operating hours of the operating system (OS)
– Operating hours of the safety system (SS)
– Signal and light/dark index of the screen failure sensor

9.5.1.1 Checking the screen failure sensor

The display failure sensor is constantly activated in Service mode.

Test results are represented graphically.
The light/dark index is additionally displayed. A value of 0/0 (light index
0 and dark index 0) indicates an optimal signal of the display failure
sensor. The quality of the signal deteriorates as the specific index rises.
Nevertheless, the signal may be adequate despite a light/dark index in
excess of 0/0. For this reason, the display failure sensor needs to be
replaced only in case of repeated error memory entries.

9.5.2 EBM – Info menu option

The DIAGNOSTICS  EBM  Info menu features the following items:

– Operating hours of the operating system (OS)
– Operating hours of the safety system (SS)

9.5.3 EBM – Test menu option

9.5.3.1 Performing the pneumatics test

The pneumatics test checks the performance of the device pneumatics

as well as checking for leaks. The pressure vessels are also checked to
ensure they are correctly connected, and to detect substantial leakage
in the positive pressure range. The Single-Needle pneumatics (option)
are not checked by the pneumatics test. The pneumatics test is
performed automatically. The device guides and informs the user
accordingly. The diagnostic results are additionally stored in the error
memory.

Warning
Risk of injury due to active door lock
 Keep hands and fingers away from the area of the door lock while
the pneumatics test is in progress.

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Note
Error in pneumatics test due to poor condition of cassette system
 Use a cassette system with the following properties:
– Dry
– Unused and undamaged
– Holes for cassette positioning pins without cracks
– Air connections without scratches and cracks
– Foil without cracks
– No deformation

Note
Error in pneumatics test due to unsuitable or incorrectly mounted
tube clamps
 Use tube clamps with a smooth surface.
 Do not damage pneumatic tubings.
 Clamp the pneumatic tubing completely closed with the tube clamp.

Requirement The installation altitude is set correctly.

 Select the Pneumatics – Test  Start field.
 Carry out the instructions given on the device.
 Remove the blood pump rotor and substituate rotor.
 Insert the cassette system and close the door.

 Clamp the tubings (1) to the pressure vessel for negative and
positive pressure at the breakthrough to the hydraulics using tube
clamps (2).
Additional tubings will need to be clamped depending on the test
procedure (see chapter 11.6.1 on page 498).
Finally, the pressure vessels are checked to ensure they are correctly
connected, so all tube clamps must be removed.
 Remove all tube clamps.

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Tip
If the system compressor runs frequently or for a long time despite the
pneumatics test having been passed, this might indicate a problem with
the pressure vessels. A passed pneumatics test only rules out the
possibility of substantial leakage from the pressure vessels in the
positive pressure range.

Tip
In the event of a major leak in the system pneumatics, for example, if
the system compressor runs frequently and/or for long periods,
diagnostics mode must be started as soon as possible after switching
on the device.
This prevents the system compressor from turning off because of
imminent overheating and slowing down the test procedure.

9.5.3.2 Performing the Single-Needle pneumatics test (option)

The Single-Needle pneumatics test (option) checks the performance of

the Single-Needle pneumatics (option) as well as checking for leaks.
The Single-Needle pneumatics test (option) is performed automatically.
The device guides and informs the user accordingly. The diagnostic
results are additionally stored in the error memory.

Warning
Risk of injury due to active door lock
 Keep hands and fingers away from the area of the door lock while
the (optional) Single-Needle pneumatics test is in progress.

Note
Error in Single-Needle pneumatics test (option) due to poor
condition of cassette system
 Use a cassette system with the following properties:
– Dry
– Unused and undamaged
– Holes for cassette positioning pins without cracks
– Air connections without scratches and cracks
– Foil without cracks
– No deformation

Note
Error in Single-Needle pneumatics test (option) due to unsuitable
or incorrectly mounted tube clamps
 Use tube clamps with a smooth surface.
 Do not damage pneumatic tubings.
 Clamp the pneumatic tubing completely closed with the tube clamp.

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Requirement The installation altitude is set correctly.

 Select the SN – Pneumatics – Test  Start field.
 Carry out the instructions given on the device.
 Insert the cassette system and close the door.
Additional tubings will need to be clamped depending on the test
procedure (see chapter 11.6.1 on page 498).

2 1

Legend

1 Pneumatic tubing BACK ← Condensate separa- 3 Pneumatic tube SN-TANK – Single-Needle air
tor (option). The pneumatic tubing BACK is black. expansion tank (option)
2 Pneumatic tubing FWD → Condensate separator
(option). The pneumatic tubing FWD is blue.

Tip
During the Single-Needle pneumatics test (option) it can be necessary
to remove the design hood.
 Mount the design hood only once the Single-Needle pneumatics test
(option) has completed successfully.

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Tip
For correct and rapid error localization, apply the following procedures:
 Fit tube clamps immediately, following the instructions given on the
device.
 Confirm the instructions given on the device directly after mounting
the tube clamp.

9.5.4 Hydraulics – Info menu option

The DIAGNOSTICS  Hydraulics  Info menu features the following

items:
– Operating hours of the operating system (OS)
– Operating hours of the safety system (SS)

9.5.5 Hydraulics – Flow diagram: Individual control menu option

In the DIAGNOSTICS  Hydraulics  Flow diagram: Individual

control menu, the hydraulics flow diagram is opened. This flow diagram
provides the possibility of separately activating valves, gear pumps and
eccentric membrane pumps (ECMP).
If the float switch has dropped, refill manually by switching the
valves!
Valves:
It is possible to open and close the individual valves by selecting the
associated valve icon on the screen.

Warning
Risk of poisoning as a result of disinfectants in the CDS
 Disconnect the device from the CDS before the CDS valves are
opened.
 Confirm on the device that the device has been disconnected from
the CDS.

Warning
Risk of spraying as a result of positive pressure in the device
 Be careful when opening connectors.
 Expect positive pressure in the device.

After having activated specific actuators, disinfect the device before

starting the next treatment (OD senses blood). However, the T1 test can
be selected.
After disinfectant valves V20 and/or V34 have been opened, a
mandatory disinfection must be initiated.

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Before this is done, the system emits appropriate messages to prompt

the operator accordingly.
The heater rod is switched off and the pumps can be activated
manually.
As soon as the Flow diagram: Individual control item is exited, all
valves are closed.
Gear pumps:
Tapping the gear pump icons in the flow diagram switches the gear
pumps on or off at a predefined speed.
Eccentric membrane pumps (ECMP):
Tapping the ECMP icons in the flow diagram causes the eccentric
membrane pumps to perform one stroke in each case.

9.5.6 Hydraulics – Test menu option

The DIAGNOSTICS  Hydraulics  Test menu features the following

tests: These tests can be started by selecting the Start field:

T1 test Requirements:
– Concentrate (acid) and bicarbonate must be connected.
– The connected concentrate is identical to the set concentrate.
 Check or adjust the concentrate entry in the CALIBRATE menu.
The following tests are performed as part of the T1 test:
– S35
– CD circuit
– S16
– Loading time
– Temp 07/08
– S50/S51
– Blood leak
– Neg. pressure
– Pos. pressure
– DIASAFE
– S09
– S10 Cleaning pgm test
– CD circuit / CD

Others – ePHT

Cleaning pgm sequences Requirements:

– The concentrate suction tube is connected to the rinse chamber.
– The bicarbonate suction tube is connected to the rinse chamber.
– Prior to performing the Test 1 and Test 2 tests, select the Test
preparation field to prepare the hydraulics for the test.

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The Cleaning pgm sequences provide the following sequences:

– Test preparation ( T )
– Heat
– V38 Test
– Level sensors
– Emptying rinse chambers
– ( T ) - V03 Rinse
– ( T ) - Test 1
– Heat exchanger/V03
– Disinfectant valves
– CDS valves
– V42
– ( T ) - Test 2
– Eccentric membrane pumps
– Disinfectant valves (positive pressure only)
– V04
– V50/V51
– V38
– V30
– Dialyzer couplings and V24/V25/V33/V43
– V42
– ( T ) - Suction V20
– ( T ) - Suction V34
– ( T ) - Suction (front)

Substituate unit – Move to service pos.

9.5.7 Power supply unit – Info menu option

In the DIAGNOSTICS  Power supply unit  Info menu, the operating

hours and the actual values of the 24 V, 18 V, and 5 V voltages as well
as the voltages of the rechargeable batteries are displayed.

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9.5.8 Radio – Info (option) menu option

The DIAGNOSTICS  Radio  Info menu features the following items:

8
7
6
1

5 2
4
3

Radio receiver:
– Address (8)
– Software version (7)
– Field strength (6)
VenAcc:
– Address (5)
– Software version (4)
– Battery (3)
– Log in (1)
– Log out (2)

9.5.9 BPM – Info / Test (option) menu option

In the DIAGNOSTICS  BPM  Info / Test menu, the serial number,

the BPU serial number, the operating hours, and the number of
measuring cycles are displayed.
In addition, it shows the fields and displays for performing the technical
safety checks relating to the BPM.

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9.5.10 BVM – Info / Sensors (option) menu option

In the DIAGNOSTICS  BVM  Info / Sensors menu, the serial

number and the operating hours are displayed.
It additionally shows the sensor status indicator with information on the
ultrasonic transit time, the head temperature (operating system), the
cuvette temperature (operating system), the NTC temperature (safety
system), and the door status.

9.5.10.1 Checking the BVM

 In the DIAGNOSTICS  BVM menu, select the Info / Sensors field.

 Fill the BVM cuvette (1) with dialysis water and close it.
 Insert the BVM cuvette (1) into the BVM measuring head.
The Ultrasonic transit time [µs] value will be updated after some
seconds.
 Check the Ultrasonic transit time [µs] value.
Target value: 10 – 11 µs
 Remove the BVM cuvette (1) from the BVM measuring head.
 Perform the check several times (insert – check – remove).
 Insert the BVM cuvette (1) into the BVM measuring head.
 Wait until the Head temperature [°C] and Cuvette temperature [°C]
values have stabilized.
 Check the difference (Head temperature [°C] – Cuvette temperature
[°C]). Target value: maximum difference 0.2 °C.
 Check the difference (Cuvette temperature [°C] – NTC temperature
[°C]). Target value: maximum difference 1.5 °C.

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9.5.11 BTM – Info / Sensors (option) menu option

In the DIAGNOSTICS  BTM  Info / Sensors menu, the serial

number and the operating hours are displayed.
It additionally shows the sensor status indicator with information on the
head temperature (operating system), the tubing temperature
(operating system), the NTC temperature (safety system), and the door
status.

9.6 SETUP menu

(see chapter 5.2 on page 94).

9.7 MODULE menu

MODULE menu

Novram Parameters (see chapter 9.7.1 on page 250)

9.7.1 Novram menu option

In the MODULE  Novram  Erase Novram completely menu, the

Novram of the following modules can be cleared:
– EBM OS
– Hydraulics OS
– Monitor SS
– EBM SS
– Hydraulics SS
 To clear the Novram, select the corresponding module and select
the Start field.
In addition, the MODULE  Novram menu can be used to delete the
mandatory disinfection and the mandatory rinse.
 To delete a mandatory cleaning program, select the Delete
mandatory disinfection or Delete mandatory rinse field.

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9.8 VARIOUS menu

VARIOUS menu

Preservation Parameters (see chapter 9.8.1 on page 251)

9.8.1 Preservation menu option

In the VARIOUS  Hydraulics menu, the preservation program can be

started with the Preservation field.

Note
Close the EBM door before starting the preservation program.
To mechanically relieve the pump rotors, the line rollers are moved out
when preservation is started.

9.9 UPDATE menu

In the UPDATE menu, individual modules or all modules (operating

system and safety system) can be updated to the software version of
the inserted CF card. In the UPDATE menu, operating systems are
displayed on the left and safety systems on the right. The software
version of the module concerned is displayed in bold. The software
version of the CF card is displayed below the software version of the
module.

9.9.1 Updating the software version in a replaced module

Note
Loss of error memory and calibration data
The error memory and calibration data on the module are no longer
available as a result of the module replacement (operating system /
safety system).
 Back up error memory and calibration data before replacing a
module.

 Switch the device on.

 Insert the ServiceCard.
A relevant message is displayed if the software version of the module
does not match the software version of the CF card.

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 Select the Service field.

If the Service field cannot be selected, additionally apply the following
three instructions.
1. Select the Status field.
2. Wait until fields 1 and 2 are displayed.
3. Enter 112 twice in succession to switch to the SERVICE menu.
 Remove the ServiceCard.
 In the SERVICE menu, select the UPDATE field.
 Select only the replaced module.
 Select the Start field.
The software version of the selected module is updated.
The device is switched off and on at the power supply unit during the
software update.
 Wait until the selected modules have been updated.
After updating the software version of the selected module (not on the
power supply unit) a green check mark is displayed.
After updating the software version of the power supply unit the device
is switched off and the On / Off status indicator flashes.
 Make sure all installed modules match the required software version.
 Pay attention to any displayed messages.
 Transfer the calibration data to the device as necessary.
 Follow the instructions for the relevant PCB (see chapter 10.14 on
page 449).
 Refer to the following chapter (see chapter 2.5 on page 19).

9.9.2 Updating the software version of the device with a new CF card

Note
Loss of error memory data
The error memory data on the module is erased by the software version
update.
 Back up error memory data before updating the software version if
necessary.

 Save the Setup settings.

 Switch off the device.
 Insert a CF card with the required software version.
 Switch the device on.
 Insert the ServiceCard.

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A relevant message is displayed if the software version of the device

does not match the software version of the CF card.
 Select the Service field.
If the Service field cannot be selected, additionally apply the following
three instructions.
1. Select the Status field.
2. Wait until fields 1 and 2 are displayed.
3. Enter 112 twice in succession to switch to the SERVICE menu.
 Remove the ServiceCard.
 In the SERVICE menu, select the UPDATE field.
If the software version of a module does not match the software version
of the CF-card, the modules to update are automatically selected.
 Select the Start field.
The software versions of the selected modules are updated.
The device is switched off and on at the power supply unit during the
software update.
 Wait until the selected modules have been updated.
After updating the software version of the power supply unit the device
is switched off and the On / Off status indicator flashes.
 Make sure all installed modules match the required software version.
 Transfer the Setup settings to the device.
 Pay attention to any displayed messages.
 Refer to the following chapter (see chapter 2.5 on page 19).
If a change to a software version entails further action or testing, the
procedures concerned will be detailed in a Technical Information
bulletin.

9.9.3 Updating the software version of the device with the PC Service Software

The software version of the device can also be updated by the PC

Service Software. For details on how to use the PC Service Software,
refer to the relevant Instructions for Use.

Note
Loss of error memory data
The error memory data on the module is erased by the software version
update.
 Back up error memory data before updating the software version if
necessary.

 Adapt the LAN connection settings as necessary using the PC

Service Software (e.g., Direct PC connect.).

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 Create connection between PC Service Software and the device

with read and write authorizations (see chapter 5.5.2 on page 135).
 Save the Setup settings.
 In the PC Service Software, select the device and the required
software version.
 In the PC Service Software, select all modules and flashes.
 Select the Offline update mode.
 Perform the software update according to the instructions from the
PC Service Software.
The software versions of the selected modules are updated.
The device is switched off and on at the power supply unit during the
software update.
 Wait until the selected modules have been updated.
After updating the software version of the power supply unit the device
is switched off and the On / Off status indicator flashes.
 Make sure all installed modules match the required software version.
 Transfer the Setup settings to the device as necessary.
 Pay attention to any displayed messages.
 Cancel settings as necessary to make the LAN connection to the PC
Service Software.
No further checks are required.
If additional work has been carried out on the device, note the
information in the relevant chapter (see chapter 2.5 on page 19).
If a change to a software version entails further action or testing, the
procedures concerned will be detailed in a Technical Information
bulletin.

9.9.4 Software version of the operating system in the monitor (M1)

The software version of the operating system in the monitor (M1) is only
updated after restarting the device (switching off and back on).
After the system is switched on, the screen remains dark for about
3 minutes during the M1 software update.

Note
Loss of data on the CF card
If the device is switched off while the M1 software is being updated,
some program components will be irretrievably deleted from the CF
card. The device will freeze with a black screen.
 Do not switch off the device while the M1 software is being updated.

If program components are irretrievably deleted from the CF card, the

CF card must be replaced.

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10 Servicing/repair

10.1 Important information on servicing/repair

Considerations for Read the information under "Considerations for working on the device"
working on the device (see chapter 2.5 on page 19).

When working on the Restore the cabling and tubing to its original routing after modifications
cabling or tubing and repairs. If a previously removed tube leaks, it must be shortened or
replaced.

Use of the error memory When carrying out repairs, the following actions should be carried out in
order to ensure optimal evaluation of the error memory:
 Back up the error memory of the device before carrying out repairs.
 Erase the error memory of the device after carrying out repairs.

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10.2 Component overview

10.2.1 Monitor

10
2

3
8

7 5

Legend

1 Monitor rear 7 PCB LP 1150 Screen failure sensor

2 PCB LP 1134 Chip card reader 8 PCB LP 1104 Monitor power supply board
3 PC board 9 PCB LP 1202-3 Monitor controller board (C167)
4 PCB LP 1145 Distribution board 10 Loudspeaker and microphone
5 PCB LP 1131 Monitor operating mode indicator
6 Monitor front with touch screen

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10.2.2 Extracorporeal Blood Circuit Module (EBM)

10.2.2.1 Front view

18

3
17 4
16

5
6
7
15
8
14

9
13 10

11
12

Legend

1 Heparin pump (option) 9 BTM - arterial measuring head (option)

2 Door with design hood 10 BTM – venous measuring head (option)
3 Door unlocking mechanism 11 Leakage sensor, Extracorporeal Blood Circuit
Press the door unlocking mechanism to open the Module
door.
12 Groove
4 Window
13 BVM (option), BTM line holder (option) or holder
The window allows inspection of the bubble
for arterial insertion site/sampling site
catcher and the Single-Needle chamber while the
door is closed 14 Tube holder for BVM (option)
5 Arterial monitoring 15 Rinse port with rinse port closure
(optical detector, air bubble detector)
16 Blood pump
6 Venous monitoring
17 Direction of rotation of manual blood return
(optical detector, air bubble detector)
18 Substituate pump
7 Arterial occlusion clamp
8 Venous occlusion clamp

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10.2.2.2 Front view (detail)

12
11 2

10

9 4
8 5
7 6

Legend

1 Cassette contact mat 7 Arterial air bubble detector

2 Cassette positioning pins 8 Arterial optical detector
3 Door lock 9 Arterial tube holder
4 Venous tube holder 10 Blood pump
5 Venous optical detector 11 Substituate unit
6 Venous air bubble detector 12 Substituate pump

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10.2.2.3 Front view (door)

Legend

1 Design hood
2 Cassette deaeration port / Single-Needle port
3 Door bolt
4 Cassette coupling port

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10.2.2.4 Rear view

1
24

23 3

22 4

21

20

19
5

6
18

17 7

16
15
8
9
14
10
11

13

12

Legend

1 PCB LP 1126 12 Valve V33

2 Air feeding unit 13 Valve V31
3 Valve V42 14 Valve V43
4 Substituate pump 15 Arterial occlusion clamp
5 Blood pump 16 Venous occlusion clamp
6 PCB LP 1178 17 Optical detectors / air bubble detectors
7 PCB LP 1202-3, OS 18 Pneumatic unit
8 PCB LP 1202-3, SS 19 Emergency unlocking valve
9 Rinse port 20 Actuator-sensor unit with air distributor board
10 Single-Needle unit (with Single-Needle option) or 21 Drawbar for door lock
vent valve V902 (without Single-Needle option) 22 Substituate unit
11 Valve V32 23 Pressure actuator
24 Single-Needle air expansion tank (option)

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10.2.2.5 Actuator-sensor unit

2
3

7
8
9
10

Legend

1 Temperature sensor 6 Pressure port for positive pressure

2 Pressure port for pressure actuator 7 Pressure port for negative pressure
3 Pressure port for emergency unlocking valve 8 Pressure port for cassette coupling
4 Actuator-sensor board 9 Pressure port for substituate pump rotor brake
5 Air distribution board 10 Pressure port for blood pump rotor brake

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Chapter 10: Servicing/repair

2
15
3

4
5

7
8
9

10
11

12

13
14

Legend

1 Cassette valve, venous insertion site 9 Single-Needle cassette valve

2 Postdilution cassette valve 10 Level detector
3 Cassette detection sensor 1 11 Pre-filter pressure transducer
4 Substituate unit 12 Cassette coupling sensor
5 Single-Needle pressure transducer 13 Venous pressure transducer
6 Single-Needle level detector (option) 14 Arterial pressure transducer
7 Cassette detection sensor 2 15 Cassette positioning pins
8 Predilution cassette valve

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10.2.3 Hydraulics

10.2.3.1 Front view

5 1

4 3

Legend

1 bibag flap 4 Concentrate suction tube (red)

2 bibag connector 5 Suction tube flap
3 Bicarbonate suction tube (blue)

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10.2.3.2 Left side view

BPM

PCB
LP 1142

V24 S10

S03 H18

CD9

H14 S08

V34

V25

V20
S07
A03

A02 S15
H09 P03

H06
CD7
H03 A05
H05
H21
H07

A04
P01

H08

Legend

(see Legend on page 505)

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10.2.3.3 Right side view

PCB
H16 LP 1106

Battery
access

H17

H15

H04

PCB LP 120 PCB LP 120

2-3 SS 2-3 OS

PCB
LP 1140
Pressure
vessel
V09 S16

P04 PCB LP 114

1-3

CD5

H22

P05
P06 S50
S51

Legend

(see Legend on page 505)

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10.2.3.4 Rear view

Legend

1 Monitor
2 External connection options
3 Push handle
1
4 Hand crank
5 Power supply
6 Fan filter
7 Filter 1 – DIASAFE® plus, right
2 8 Filter 2 – DIASAFE® plus, left
3 9 Dialysis fluid particle filter (not
available in all devices)
4
5 10 Disinfectant connector H20
6
11 Disinfectant connector H35
12 Heater rod chamber measurement
7 point
8 13 Equipotential bonding connection
9
10 14 Overflow (water inlet chamber)
11 15 Fuse for rechargeable battery
16 Dialysis water connector (permeate)
or connector for water inlet filter H01
17 Rechargeable battery compartment
12
13 18 Drain H19
19 Flush drain H02 (option)
22
20 Leakage sensor flap
21
14
20 21 CDS connector 1, red H29
15 (central delivery system)
Acid (option)
22 CDS connector 2, red H31
(central delivery system)
19 18 17 16
Acid (option)

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10.2.3.5 Rear view with connectors

2
3

Legend

1 Disinfectant connector H20 5 Flush drain H02 (option)

2 Disinfectant connector H35 6 Drain H19
3 CDS connector 1, red H29 7 Dialysis water connector (permeate) or connector
(central delivery system) for water inlet filter H01
Acid (option)
8 Overflow (water inlet chamber)
4 CDS 2 connector, red H31
9 Storage area for disinfectant container
(central delivery system)
Acid (option)

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10.3 Basic procedures

10.3.1 Performing the T1 test

Requirement Operating mode: Standby

Note
Time-reduced T1 test without the DIASAFE test step
The DIASAFE test step is not carried out during every T1 test to reduce
the duration of the T1 test.
Only after the following events occur is the next T1 test carried out with
the DIASAFE test step:
– DIASAFE test step failed
– Start of a new day (first T1 test after 0:00)
– From the fourth treatment carried out since the last passed
DIASAFE test step
– Filter change program performed
– Degreasing / cold disinfection cleaning program performed
– SERVICE menu was opened
To carry out a T1 test with the DIASAFE test step, perform the following
steps:
1. Switch to the SERVICE menu.
2. Switch the device off and back on again.
3. Start the T1 test.

Start the T1 test  Connect the concentrates.

 Select the concentrates as necessary.
 Select the DIALYSATE MENU menu.
 Select the Flow field.
Message: Start T1 test? – Yes – No
 Select the Yes field.

T1 test completed Message: T1 test completed. – OK

 Select the OK field.

Running the rinse program Unless you need to run a cleaning program anyway in the course of
your work on the device, you must run at least one rinse program. The
rinse program rinses out the previously connected concentrates.
 Remove concentrates.
 Select the CLEANING menu.
 Select the Rinse field.
 Select the Start field.
Message: Rinsing finished. – Continue

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10.3.2 Performing the EBM T1 test

Requirement Operating mode: off

Starting the EBM T1 test The EBM T1 test runs automatically immediately after the device starts
up.
 Switch the device on.

EBM T1 test completed If no EBM message is displayed while the device is still in Standby
mode, the EBM T1 test has been completed successfully.

10.3.3 Measuring the protective earth resistance

according to (DIN) EN 62353:2015, IEC 62353:2014

Measuring the protective  Remove any external test equipment.

earth resistance
 Connect the dialyzer couplings to the shunt interlock.
 Close the shunt interlock.
 Unplug the power plug of the device.
 Plug the test equipment for the electrical safety check into the AC
power supply.
 Plug the power plug of the device into the test equipment for the
electrical safety check.
 Make sure the power switch on the rear of the device is switched on.
 Set the test equipment for the electrical safety check to the mode for
measuring the protective earth resistance.
 Check the protective earth resistance at the following measurement
points.
Target value: ≤ 0.3 Ω with power supply cord
A test current between 200 mA and 1 A is recommended for measuring
the protective earth resistance so that interruptions or unstable
connections (loose contacts) can be detected clearly. Using a higher
test current may have a welding effect and, as a result, make unstable
connections appear to be good connections.

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 Measure the protective earth resistance at

the power supply unit (1).

 Measure the protective earth resistance at

the shunt interlock flap (2).

3
 Measure the protective earth resistance at
the heater rod chamber (3).
 Measure the protective earth resistance at
4 the equipotential bonding connection (4).

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 Measure the protective earth resistance at

the following pumps in the EBM:
– Blood pump
– Substituate pump (5)

 Measure the protective earth resistances

at the following points on the EBM using a
6
test current of 200 mA:
– Cassette positioning pin (right) (6)
– Door lock (7)
7
This is necessary to avoid scorch marks and
damage.

 Remove the screw protection cap.

 Measure the protective earth resistance
on the door (non-anodized hole) (8) using
a test current of 200 mA.
This is necessary to avoid scorch marks and
8 damage.
 Insert the new screw protection caps.

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 Measure the protective earth resistances

9 at the following points on the BTM (option)
using a test current of 200 mA:
10 – Arterial measuring head (9)
– Venous measuring head (10)
This is necessary to avoid scorch marks and
damage.

 Measure the protective earth resistance

on the BVM (11) (option) using a test
current of 200 mA.
This is necessary to avoid scorch marks and
damage.
11

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10.3.4 Measuring the device leakage current

according to (DIN) EN 62353:2015, IEC 62353:2014

Measuring the device  Remove any external test equipment.

leakage current
 Connect the dialyzer couplings to the shunt interlock.
 Close the shunt interlock.
 Unplug the power plug of the device.
 Plug the test equipment for the electrical safety check into the AC
power supply.
 Plug the power plug of the device into the test equipment for the
electrical safety check.
 Set the test equipment for the electrical safety check to the mode for
measuring equipment leakage currents.

Requirements – Protective earth resistance measured and checked.

– Device is at operating temperature.
– Dialysate temperature: ≥ 36 °C
– Dialysate flow: ≥ 300 ml/min
– Dialysate conductivity: ≥ 13 mS/cm

Additional requirements – The device must be isolated from earth during the measurement.
for direct measurement – All external lines must be disconnected from the device.
according to figure 7 – Do not touch the device while the measurement is in progress.

Fig.: Differential current measurement according to figure 8

Fig.: Direct measurement according to figure 7

 Set up the device for differential current measurement according to

figure 8 or for direct measurement according to figure 7.

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Operating mode: Preparation Operating mode: Service

 Connect the concentrates as necessary.

 Select the concentrates as necessary.

 Select the DIALYSATE  Select the CALIBRATE

MENU menu. menu.

 Select the Temperature field.  Select the Desired

temperature field.

 Set Temperature ≥ to  Set Desired temperature ≥

37.0 °C. to 37.0 °C.

 Select the Flow field.  Select the Desired flow field.

 Set Flow ≥ to 300 ml/min.  Set Desired flow ≥ to

300 ml/min.

 Switch on Flow as necessary.

 Check the dialysis fluid for the following values:

– Dialysate temperature: ≥ 36 °C
– Flow: ≥ 300 ml/min
– Conductivity: ≥ 13 mS/cm

 Record the nominal voltage of the power supply (U0).

AC polarity L – N:
 Measure and record the maximum device leakage current (IBmax).
 Measure and record the actual line voltage (UBmax).
 Scale the measured device leakage current value to the nominal line
voltage and record it (IN).
Formula: IN = (U0 x IBmax): UBmax
 Check the scaled device leakage current (IN), taking the "Additional
condition" (see Additional condition on page 275) into account.
Target value: IN ≤ 500 μA

AC polarity N – L:
 Change AC polarity (from L – N to N – L).
 Measure and record the maximum device leakage current (IBmax).
 Measure and record the actual line voltage (UBmax).
 Scale the measured device leakage current value to the nominal line
voltage and record it (IN).
Formula: IN = (U0 x IBmax): UBmax
 Check the scaled device leakage current (IN), taking the "Additional
condition" (see Additional condition on page 275) into account.
Target value: IN ≤ 500 μA

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Additional condition If either of the scaled device leakage current values (IN) is higher than
450 μA, the last scaled device leakage current values (IN–1) must
additionally be considered for the rating.
 Find out the last scaled device leakage currents (IN–1).
 Calculate and check the device leakage currents taking the
"Additional condition" into account (IA).
Formula: IA = IN + (IN – IN–1)
Target value: IA ≤ 500 μA

Examples – Example of a successful measurement:

Nominal voltage of the power supply (U0) 230 V

Maximum device leakage current (IBmax) 180 μA

Actual line voltage measured (UBmax) 225 V

Scaled device leakage current (IN) 184 μA

IN = (U0 × IBmax): UBmax
IN = (230 V × 180 μA): 225 V

Target value: IN = 184 μA ≤ 500 μA? Value OK

Additional condition: IN = 184 μA < 450 μA? Value OK

Measurement result: Measurement passed

– Example of a successful measurement taking last scaled device

leakage currents into account:

Nominal voltage of the power supply (U0) 230 V

Maximum device leakage current (IBmax) 474 μA

Actual line voltage measured (UBmax) 232 V

Scaled device leakage current (IN) 470 μA

IN = (U0 × IBmax): UBmax
IN = (230 V × 474 μA): 232 V

Target value: IN = 470 μA ≤ 500 μA? Value OK

Additional condition: IN = 470 μA < 450 μA? Value not OK

Take last scaled device leakage currents (IN–1) into account.

Last scaled device leakage current (IN–1) 450 μA

Device leakage current according to "Additional 490 μA

condition" (IA)
IA = IN + (IN – IN–1)
IA = 470 μA + (470 μA – 450 μA) = 490 μA

Target value: IA = 490 μA ≤ 500 μA? Value OK

Measurement result: Measurement passed

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– Example of a failed measurement:

Nominal voltage of the power supply (U0) 230 V

Maximum device leakage current (IBmax) 474 μA

Actual line voltage measured (UBmax) 232 V

Scaled device leakage current (IN) 470 μA

IN = (U0 × IBmax): UBmax
IN = (230 V × 474 μA): 232 V

Target value: IN = 470 μA ≤ 500 μA? Value OK

Additional condition: IN = 470 μA < 450 μA? Value not OK

Take last scaled device leakage currents (IN–1) into account.

Last scaled device leakage current (IN–1) 390 μA

Device leakage current according to "Additional 550 μA

condition" (IA)
IA = IN + (IN – IN–1)
IA = 470 μA + (470 μA – 390 μA) = 550 μA

Target value: IA = 550 μA ≤ 500 μA? Value not OK

Measurement result: Measurement failed

Running the rinse program Unless you need to run a cleaning program anyway in the course of
your work on the device, you must run at least one rinse program. The
rinse program rinses out the previously connected concentrates.
 Remove concentrates.
 Select the CLEANING menu.
 Select the Rinse field.
 Select the Start field.
Message: Rinsing finished. – Continue

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10.3.5 Laying the device on its back

Proceed as follows to tilt the device:

 Apply the brake.
 Close both side panels (see
chapter 10.6.9 on page 291).
For reasons of stability, the device must only
be tilted back when the side panels are
closed.
 Insert the transport protection for the
monitor support arm (see chapter 10.9.1
on page 297).
1
 Position the tilting tool (1).
 Carefully lay the device on its back.

10.3.6 Installing components with SNAPLOC attachments

1  Insert the hook (3) of the component

2
slightly tilted into the buffer (2).
3 Legend:
1 Chassis plate
2 Buffer
3 Hook geometry
4 Coupling
4 5 Bolt
5

 With the hook (3) inserted, move the bolt

(5) of the component towards the coupling
(4).

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 Slightly press the bolt (5) into the coupling

(4).

10.3.7 Mounting components with self-cutting screws

Many components are screwed into the

plastic housing by means of self-tapping
screws.
Observe the following when screwing in the
screws:
1. The screw must be perpendicular to the
hole when inserted.
The screw head must sit parallel with the
surface of the component.
2. Avoid cutting a new thread.
To this end, turn the applied screw
counterclockwise with slight pressure until
you can just feel it locking into the thread.
Applying only minimum force, turn the
screw clockwise until it screws into the
thread.
3. Tighten the screw with the torque
specified.

10.3.8 Closing and opening the tube clamp

1 2
Closing the tube clamp
 Position the tube clamp at a distance from
the tubing end (1) and from the thickened
end (2) of the adapter fitting.
If the tube clamp is not positioned in the
recess of the adapter fitting, leaks may
develop.

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 Close the tube clamp as shown in the

figure.

3
 Press the tube clamp together (3)
completely.

Open tube clamp (depending on tube

clamp):
 Position a side cutter on the tube clamp as
shown in the figure.

 Open the tube clamp by rotating the side

cutter.

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10.3.9 Connecting the tubing to the adapter

Fig.: Adapter with adapter stop (example)

4 1

3 2

Adapter bulge Each adapter (1) has an adapter bulge (2). The adapter bulge (2) can
be rounded or angular. An angular adapter bulge can shear off tube
particles when the tube is attached. Sheared-off tube particles can lead
to malfunctions in the hydraulics.

Adapter stop By design, an adapter (1) may also have an adapter stop (3). When the
tube is attached to the adapter stop (3), leaks may occur.

Procedure  Observe the geometry of the adapter bulge(2).

 Carefully push the tube (4) over the adapter bulge (2) until just
before the adapter stop (3).
 Make sure that no tube particles have been sheared off.

10.4 Wrench torques

Designation Specified wrench torque

Monitor housing

Attached with 5 screws 40 Ncm

IV pole

Threaded pin of the IV pole 90 Ncm

Heparin pump New version with two threaded pins

Threaded pin of the drive shaft from the heparin pump drive 60 Ncm

Threaded pin of the slide carriage to the heparin pump drive 60 Ncm

Heparin pump Old version with one threaded pin

Threaded pin of the bearing sleeve of the heparin pump 90 Ncm

Dialyzer holder

Attached by 1 screw 70 Ncm

Design hood

Attached with 5 screws 230 Ncm

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Designation Specified wrench torque

Door ports

Cassette deaeration port 350 Ncm

Cassette coupling port 350 Ncm

Components of the actuator-sensor unit

Pressure transducer – Pressure ring 350 Ncm

Pressure transducer – Threaded pin 230 Ncm

Cassette sensors – Attached with 1 screw 60 Ncm

Frame of the cassette contact mat – Attached with 8 screws 90 Ncm

Pressure actuator

Pressure actuator with swivel plates 230 Ncm

Lever arm between pressure actuator and drawbar 130 Ncm

Air bubble detector (ABD)

Attached with 2 screws 60 Ncm

bibag connector in devices with EC < 055

Phillips screw 50 Ncm

bibag connector in devices with EC ≥ 055

Phillips screw 130 Ncm

Pressure transducer in the hydraulics

Attached with 4 screws 90 Ncm

Blood and substituate pump drives

Attached with 4 screws 230 Ncm

Rotor brake

Attached with 2 screws 130 Ncm

Protective earth conductor

Protective earth conductor screws 230 Ncm

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10.5 Tube clamps

Designation Diameter range Type Possible position on the device

[mm]

12.8 RER 10.3 to 12.3 Tube clamp Connection of Central Delivery

System (media supply rail)

13.3 706R 10.8 to 13.3 Tube clamp Regulator

13.8 RER 11.1 to 13.1 Tube clamp Connection of dialysis water inlet
(media supply rail)
Connection of flush drain (media
supply rail) with double-lumen tubing
Sampling valve

14.5 RER 11.8 to 13.8 Tube clamp Heat exchanger

17.5 RER 14.6 to 16.8 Tube clamp Connection of drain (media supply
rail) with double-lumen tubing

18.5 RER 15.6 to 17.8 Tube clamp Connection of drain (media supply
rail) with single-lumen tubing

Black colored wire tube 11.6 to 12.3 Wire tube clamp Pressure-carrying tubings inside the
clamp device

Silver wire tube clamp 12.1 to 13.1 Wire tube clamp Pressure-carrying tubings inside the
device

Silver wire tube clamp 8.8 to 9.3 Wire tube clamp Pressure-carrying tubings inside the
device

SNP-1,5G Tube clip V31 (gray angled nozzle)

SNP-2G Tube clip V31 (white angled nozzle)

SNP1 Tube clip BPM

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10.6 Housing

10.6.1 Removing and installing the IV pole

Removal:
 Move the cap on the monitor support arm
upward.
 Remove the 2.5 mm threaded pin (1).
 Lift the IV pole to remove it.
1
Installation:
 Perform the installation in reverse logical
order.
Specified wrench torque for threaded pin (1):
90 Ncm

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.6.2 Removing and installing the shunt interlock

Removal:
1  Remove the connectors for the
microswitches of the shunt interlock
3 X_S04_S05_S06 from PCB LP 1140 /
electronics chassis (see chapter 10.14.8
on page 458).
 Remove the two cable ties (1).

2  Remove the shrink tube (2).

 Protect components from leaking fluid.
 Pull off the tubings (3).

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6  Remove the nut (4) and washer.

5  Remove the protective earth conductor (5)
leading to the device.
 Remove the protective earth conductor (6)
leading to the shunt interlock.
4
 Remove the toothed washer.

 Remove the six self-tapping screws (7).

 Remove the shunt interlock.

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14 8
Installation:
 Perform the installation in reverse logical
order.
9
13  Fit the toothed washer (10).
 Fit the protective earth conductor (8)
12 10 leading to the shunt interlock as shown.
The crimping (9) of the ring cable lug points
towards to the toothed washer (10).
11  Fit the protective earth conductor (14)
leading to the device as shown.
– The protective earth conductor (14) is
connected to the housing (left-hand
side of the device).
The crimping (13) of the ring cable lug points
towards to the nut (12).
 Fit the washer (11).
 Tighten the nut (12).

 Connect the tubings to the adapter.

15
 Ensure that the marked tubings (15) are
connected to one another.
 Position and shrink a new tube (16).
 Check that the color coding of the dialyzer
couplings and the shunt interlock are in
16 accordance with the customer’s
requirements.

Check  Check the microswitches in the flow diagram.

– S4 = microswitch at dialyzer coupling inlet port
– S5 = microswitch at flap
– S6 = microswitch at dialyzer coupling outlet port

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

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10.6.3 Removing and installing the microswitch in the installed shunt interlock

Removal:
 Remove the connectors for the
microswitches of the shunt interlock
X_S04_S05_S06 from PCB LP 1140 /
electronics chassis (see chapter 10.14.8
1 on page 458).
The microswitches are replaced from the
inside of the device.
 Remove the EMC plate, if present.
2  Open the Phillips screw (1) to remove the
microswitch for the flap.
 Remove the two Phillips screws (2) to
remove the microswitches for the dialyzer
couplings (there are washers between the
microswitches and the covers).
 Open the strain relief to remove the cable.
 Remove the microswitches.

Installation  Perform the installation in reverse logical order.

 Check the microswitches in the flow diagram.
– S4 = microswitch at dialyzer coupling inlet port
– S5 = microswitch at flap
– S6 = microswitch at dialyzer coupling outlet port

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

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10.6.4 Removing and installing the shunt interlock mark

Removal:
 Open the protective cap (1) using a small
screwdriver.
1
 Remove the Phillips screw.
 Remove the color plate (2).
2
Installation:
 Perform the installation in reverse logical
order.
 Adjust the color coding according to the
customer's specifications.

Final tasks No final tasks needed.

10.6.5 Removing and installing the dialyzer coupling

1
Removal:
 Open the screw union on the dialyzer
coupling using the ring wrench (1).
The ring wrench is supplied in the
2 accessories package or the 5008/S tool kit.
 Pull off the tubing from the dialyzer
coupling.

Installation  Cut off about 1 cm from the end of the tubing.

 Use the correct screw fitting (2), making sure that the arrow indicates
the flow direction.
 Push the tubing and the clamping ring completely onto the dialyzer
coupling.
 Close the screw fitting on the dialyzer coupling using the ring wrench
(1).

Final tasks  Run a disinfection program.

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10.6.6 Removing and installing the dialyzer holder

Removal:
 Loosen the threaded pin (1) of the dialyzer
holder.

 Remove the dialyzer holder.

Installation:
 If no new threadlocker has been applied to
the threaded pin (2): Apply 1 drop of
Loctite 243 threadlocker to the thread of
the threaded pin.

2  Screw the dialyzer holder in place with the

threaded pin (2).
Specified wrench torque for threaded pin (2):
70 Ncm

Final tasks No final tasks needed.

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10.6.7 Removing and installing the blood pressure monitor (BPM) (option)

Removal:
 Open the EBM (see chapter 10.11.2 on
page 328).
1
 Open both side panels (see
chapter 10.6.9 on page 291).
 Remove BPM connector on PCB
LP 1106.
 Disconnect the pressure tubing (2) from
2 the blood pressure cuff holder.
 Detach and remove the BPM (1) (option).

 Remove the blood pressure cuff holder (3)

as necessary.

Installation  Perform the installation in reverse logical order.

 If necessary, update the software version of the module (see
chapter 9.9.1 on page 251).
 Select the Status field and check the availability of the module.
 Perform a trial measurement.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.6.8 Opening and closing the media supply rail

Opening the media supply rail:

1  Remove the 4 screws (1).
 Withdraw the media supply rail about
2 cm.
 Remove the locking plate (2) on the
overflow tube.
 Pull the media supply rail out further.
3 2
Closing the media supply rail:
 Close in reverse logical order.
 Check that the flap (3) opens inward.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.6.9 Opening and closing the side panel

Opening the side panel:

 Loosen the Allen screw (2) on the edge of
the rear panel.
 Loosen the Allen screws (1).
 Remove the protective earth conductor.
 Remove the side panel.
Closing the side panel:
 Close in reverse logical order.
This description applies to the left and right
side panels.

1
2

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.6.10 Removing and installing the positioning handles (option)

This description applies to the left and right side positioning handles.

Removal:
 Open the EBM (see chapter 10.11.2 on
page 328).
 Remove the 2 screws (1) from the locking
mechanism (2).
 Detach the locking mechanism (2) from
2 1 the rod in the direction indicated by the
arrow.
 Set down the locking mechanism (2) in the
device.

 Hold the positioning handle (3).

 Unscrew the 2 self-tapping screws (4) and

remove the positioning handle.

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Installation:
 Perform the installation in reverse logical
order.
5
Check:
6
 Check the position of the positioning
handles.
Target value: The convex side (5) faces
upward. The concave side (6) faces
downward.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.7 Cart

10.7.1 Removing and installing the concentrate container holder

 Devices with holding spring made of plastic

Removal:
1. Push the concentrate container holder
away from the direction of removal
slightly.
2. Remove the concentrate container holder
1 downward at a slight angle.
2

Installation  Slot the concentrate container holder into the guide until the holding
springs engage on both sides.

Final tasks No final tasks needed.

10.7.2 Removing and installing the braking mechanism

The following three different types of swivel rollers with the

corresponding brake mechanism may be installed on the device:
– Double swivel roller
– Profiled swivel roller
– Non-profiled swivel roller
The double swivel roller can be used when streaks are caused by the
profiled swivel roller. The double swivel roller is installed as standard.
The profiled or non-profiled swivel roller was installed in older devices.
Each type of swivel roller requires its own braking mechanism. Mixing
of swivel roller types is not permitted.

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Removal:
 Insert the transport protection for the
1
monitor support arm (see chapter 10.9.1
on page 297).
 Lay the device on its back (see
chapter 10.3.5 on page 277).
 Release the brake.
 Remove all 4 swivel rollers.
 Remove the 4 mounting screws (1).
 Remove the 2 mounting screws (2).
 Remove the brake completely with the
swivel rollers.
Installation:
2
 Perform the installation in reverse logical
order.
 Always use a spring washer with the
metric screws.
 Do not use a spring washer with the
self-tapping screws.

Check  Make sure that only one type of brake roller with the corresponding
brake mechanism has been installed.
 Lift the device back onto its swivel rollers and check that the brake
works.

Final tasks No final tasks needed.

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10.8 Rechargeable batteries

10.8.1 Removing and installing the rechargeable battery pack

1
Removal:
 Switch off the device.
The cover of the rechargeable battery is
located under the media supply rail.
 Remove the two screws (1) and remove
the cover.

 Unplug the connector (2).

 Remove the rechargeable battery.
Installation:
 Perform the installation in reverse logical
order.
2
 During installation, ensure that the plug is
in the correct position.

Final tasks  Run the T1 test for at least one minute to test the rechargeable
battery (see chapter 10.3.1 on page 268).

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10.9 Monitor

10.9.1 Locking and releasing the monitor support arm

Locking the monitor support arm:

 Push the cap on the monitor support arm
upwards.

 Remove the 2.5 mm threaded pin (1).

 Lift the IV pole (2) to remove it.

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 Align the monitor support arm parallel to

the front edge of the device.
 Screw in the M5 x 50 oval head screw (3).
 Tilt the monitor to the rear.

Releasing the monitor  Bring the monitor to the upright position.

support arm
 Remove the M5 x 50 oval head screw (3) and keep it for later
transport.
 Insert the IV pole (2) into the monitor support arm.
 Screw in the 2.5 mm threaded pin (1).
Specified wrench torque for threaded pin (1): 90 Ncm
 Fit the cap on the monitor support arm.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.9.2 Opening and closing the monitor

Warning
Risk of injury as a result of an electric shock
If the backlight is generated by a device-dependent fluorescent tube
with inverter, contact with live parts can lead to an electric shock.
 Switch off the device.
 Unplug the power plug.

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Opening the monitor:

 Remove the 5 closing plugs (1).
 Loosen the 5 screws (1).
 Carefully tilt the monitor to the front.
1

Closing the monitor  Carefully close the monitor front.

 Ensure that no cables, seals etc. are crushed.
 Screw in the 5 screws (1).
Specified wrench torque of the 5 screws (1): 40 Ncm
 Insert the 5 closing plugs (1).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.9.3 Adjusting monitor axes

The monitor’s position can be adjusted on

three axes.
– Axis 1 – Monitor rear / joint (see
chapter 10.9.3.1 on page 300)
1 – Axis 2 – Joint / monitor support arm (see
chapter 10.9.3.2 on page 300)
– Axis 3 – Monitor support arm / device (see
2 chapter 10.9.3.3 on page 301)
3

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10.9.3.1 Adjusting monitor axis 1

Adjusting monitor axis 1:

1  Open the monitor (see chapter 10.9.2 on
page 298).
 Lay the monitor on its back.
 Protect the monitor against damage.
 Remove the threaded pin (1) from the lock
2 nut (2) with a 2.5 mm Allen wrench.
3
 Remove the brass bolt (3) located under
the previously removed threaded pin (1).

 Adjust the lock nut (2) with a 5 mm Allen wrench until the monitor can
be easily moved but remains in place in all positions.
 Insert the brass bolt (3) into a suitable thread in the lock nut (2).
 Screw the threaded pin (1) into the thread with the brass bolt (3)
using Loctite 243 threadlocker.
 Close the monitor.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.9.3.2 Adjusting monitor axis 2

Adjusting monitor axis 2:

 Remove the screw (1).

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 Press on the marked points (2) and

remove the cover (3).

 Remove the threaded pin (4) with a

2.5 mm Allen wrench.
 Adjust the lock nut (5) with a 5 mm Allen
wrench until the monitor can be easily
moved but remains in place in all
positions.
 Screw in the threaded pin (4) using Loctite
4 243 threadlocker.
5  Close the cover (3).
 Screw in the screw (1).

Final tasks No final tasks needed.

10.9.3.3 Adjusting monitor axis 3

1 Adjusting monitor axis 3:

 Move the cap (1) on the monitor support
2 arm upwards.
 Remove the protective cap (2).
3
 Remove the threaded pin (3) with a
2.5 mm Allen wrench.

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 Adjust the lock nut (4) with a 5 mm Allen

wrench until the monitor can be easily
moved but remains in place in all
positions.
4
 Screw in the threaded pin (3) using Loctite
243 threadlocker.
 Replace the protective cap (2).
 Move the cap (1) on the monitor support
arm down to its original position.

Final tasks No final tasks needed.

10.9.4 Monitor matrices

10.9.4.1 Matrix for selecting spare parts

The following matrix shows the allowed and forbidden hardware states
of the monitor. The matrix also distinguishes between the delivered
hardware state and a modified hardware state because a different
hardware state may be present due to previously performed measures,
which needs to be appropriately taken into consideration. A general
allocation on the basis of the equipment code is not possible.

 Determine the ETX revision (1) of the PC

board (green).
 Determine the baseboard revision (2) of
the PC board (blue).
 Determine the LVDS frequency (3)
(yellow).
– F40002704 = 62 MHz, BB 8.0, ETX 5.0
– F40007053 = 40 MHz, BB 8.0, ETX 5.0
– M39724 = 40 MHz, BB 7.1, ETX 4.4

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 Determine whether the monitor support

arm is equipped with EMC sliding
contacts.
For monitor support arms with EMC sliding
contacts, the carrier plate (4) also has four
screws for the EMC sliding contacts (red
marks).
4

 Determine whether the EMC ferrite from

PC board⏐X2  PCB LP 1142⏐X_LAN
(5) is installed.

 Determine whether the EMC ferrite from

PCB LP 1142⏐X_LAN  PC board⏐X2
(6) is installed.
 Determine the component to replace
based on the established hardware state
and according to the associated
description.
6

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Established hardware state Component to replace

on the monitor support arm

EMC sliding contacts

Monitor support arm

NLB150XG01L-01

NL10276BC30-17
LVDS frequency

Hardware state

TM150TDS50

Monitor front
Monitor type

Monitor type

Monitor type
EMC ferrites

Monitor rear
PC board

PC board
FM2: ETX ≥ 5.0 and baseboard 62 MHz Yes Yes S 1 2 4 NA 5
≥ 8.0
Yes Yes M 1 2 4 5

No Yes X NA

No No X NA

Yes No X NA

40 MHz Yes Yes M 1 2 4 5

No Yes M 1 3 4 5

No No M 1 3 4 5

Yes No M 1 3 4 5

FM1: ETX ≤ 4.4 and baseboard 40 MHz No No S 1 3 4 5

≤ 7.1
No Yes M 1 3 4 5

Yes Yes M 1 2 4 5

Yes No M 1 3 4 5

Hardware state Component to be installed

S Device was delivered 1 Monitor rear with monitor support arm
with this hardware state 2 PC board FM2 with ETX ≥ 5.0, baseboard ≥ 8.0 and LVDS frequency 62 MHz
(series production 3 PC board FM2 with ETX ≥ 5.0, baseboard ≥ 8.0 and LVDS frequency 40 MHz
status). 4 Monitor type TM150TDS50 or monitor type NL10276BC30-17 (see chapter 10.9.4.2
M Device has already been on page 305)
modified (not series 5 Monitor front
production status)
X Device has a forbidden
hardware state

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10.9.4.2 Monitor compatibility matrix

Monitor type NLB150XG01L-01 TM150TDS50 NL10276BC30-17

Permitted PCBs PCB LP 1145-1 PCB LP 1145-1 PCB LP 1145-1

SP index: ≥ h SP index: ≥ h SP index: all

Backlight LED without LED without Fluorescent tube

inverter inverter with inverter

Line to screen

Line to backlight

Screen 3.3 V 3.3 V 3.3 V

PCB LP 1104 – BR1 Closed Closed Closed

PCB LP 1104 – BR2 Open Open Open

PCB LP 1104 – BR3 Open Open Open

Backlight 12.0 V 12.0 V 12.0 V

PCB LP 1104 – BR4 Closed Closed Closed

PCB LP 1104 – BR5 Open Open Open

10.9.5 Removing and installing monitor front with screen

Note
Monitor can be destroyed by wrong voltage
 Check the solder bridges of PCB LP 1104 against the compatibility
matrix (see chapter 10.9.4.2 on page 305).
 Only do this with the device switched off (without the solder bridges,
voltage supply is 24 V).

Note
Monitor can malfunction if connected with wrong cables
 Only use the supplied wiring for the screen and the backlight
(see chapter 10.9.4.2 on page 305).

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X_SCREEN_SENS

R65 DR19
R17
R55
R53

R58
T3

Removal:
R56

1 T4
R61
R8
R59
T2

R60

5
2
1

D1
X6_BACKLIGHT
C62
X3_LVDS

RL1

 Open the monitor (see chapter 10.9.2 on

1
2
C57

RL3
R30
1

R29

page 298).
D9
X1_EXT/IO

X10_DISPLAY
T6

T7

R44 R45
R43
R66
R42

R67 R64 R48

C29
1
2

R15 R49
R72

R50

 Disconnect the following connectors from

R14
IC2

1
R16

4
R13
R12
C14 R69
DR12

DR3
DR9
DR7
DR5
DR4

1
DR15

C15

the PC board:
R24
C60
DR16
DR11
DR10
DR6
DR1
DR8
DR2

C13
R63
C5

R27
D13
1

C25
IC8

X7

– X29 (1)
C56

XCPU2

R23
C61

R36 R28
C22
IC9

R31
R37 R32
R20
C55
C12

R46

C23 C11
C44

– X2 (2)
D11 R10
R38
D7
R39 R40

a
8

D8
R19
T1

IC7
C24
R26

D12 R11
R54

 Disconnect the following connectors from

C53

IC4

C36 +
PCB LP 1145-1:
– X2_LS/MIC (3)
C21

C39
C35
C34

R6 R9 R71
C38 R70
DR17

R3 R5 C37
C2 R7
C32

C41
C19

R1
IC5
R22

R57
X2_LS/MIC
DR18
C10R21

– X7 (4)
R4

R68
C31

C33
IC1
P1

C59
C28

DR14

C1
1
R2

C58

– X1_EXT/IO (5)
2
3
DMC
DR30
DR22
DR25
DR26
DR23
DR31
R73

DR33

DR35
DR34
DR21
DR32
DR27
DR28
DR24
DR29

1 1

X9 X5
MXJ

 Open the cable holder (6).

 Disconnect the following connectors from
PCB LP 1104:
– X2 (7)
– XACCU (8)
6
 Detach the strain-relief cable (9) on the
7
monitor front with screen.
8
9

 Slightly close the monitor front with

screen.
 Carefully lift the monitor front with screen
up and away from the 4 retaining screws
(10).
10

Installation  Perform the installation in reverse logical order.

 Transfer the labels from the monitor, if necessary.
 Refer to the monitor compatibility matrix (see chapter 10.9.4.2 on
page 305).

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Calibration/testing:
 Read the material abbreviation (11) on the
11
monitor front.
 Read the material abbreviation (12) on the
monitor rear.
 Make sure that the monitor front and
monitor rear are made of the same
material. Mixing of material types is not
permitted.
12
 If necessary: Replace monitor front or
monitor rear with support arm.
Material abbreviations:
– ABS: Material STAREX ABS VE-0856.
– PC+ABS-GB: Material PC ABS Romiloy.

 Verify the correct position of the connectors on PCB LP 1104 (see

chapter 10.14.1 on page 449).
 Verify the correct position of the connectors on PCB LP 1145 (see
chapter 10.14.11 on page 465).
 Verify the correct position of the connectors on PC board (see
chapter 10.14.18 on page 475).
 When switching on the device, check the operating status indicator
and LEDs on the monitor front.
 Insert a ServiceCard to test the card reader.
A T will be displayed in the status bar.
 Consecutively press and hold the Audio Paused, Blood System
Start and Blood System Stop buttons until the target point appears
at the upper left of the screen.
 Calibrate the touch screen.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.9.6 Removing and installing monitor front

Note
Monitor can be destroyed by wrong voltage
 Check the solder bridges of PCB LP 1104 against the compatibility
matrix (see chapter 10.9.4.2 on page 305).
 Only do this with the device switched off (without the solder bridges,
voltage supply is 24 V).

Note
Monitor can malfunction if connected with wrong cables
 Only use the supplied wiring for the screen and the backlight (see
chapter 10.9.4.2 on page 305).

1
Removal:
2
 Open the monitor (see chapter 10.9.2 on
page 298).
 Remove the monitor front with screen (see
3
chapter 10.9.5 on page 305).
 Place the monitor front with screen on a
clean surface.
 Remove PCB LP 1131 (3) from the holder.
 Lift the tab (2) slightly and remove the
housing (1).

 Open the locks on the two foil cables (5).

 Pull the foil cables (5) out of the monitor
front.
 Unscrew the 4 screws (4) to remove the
monitor front and screen with mounting
4 frame.
 Remove the monitor front.

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Installation:
 
 Perform the installation in reverse logical
order.
 Clean the screen and the monitor front
with an antistatic cloth.
 Screw in the screws in the order shown (
to ).
 Transfer the labels from the monitor, if
necessary.
 Refer to the monitor compatibility matrix
 
(see chapter 10.9.4.2 on page 305).

 Route the cable to PCB LP 1131 through

the guide slots (6).

Calibration/testing:
 Read the material abbreviation (7) on the
7
monitor front.
 Read the material abbreviation (8) on the
monitor rear.
 Make sure that the monitor front and
monitor rear are made of the same
material. Mixing of material types is not
permitted.
8
 If necessary: Replace monitor front or
monitor rear with support arm.
Material abbreviations:
– ABS: Material STAREX ABS VE-0856.
– PC+ABS-GB: Material PC ABS Romiloy.

 Verify the correct position of the connectors on PCB LP 1104 (see

chapter 10.14.1 on page 449).

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 Verify the correct position of the connectors on PCB LP 1145 (see

chapter 10.14.11 on page 465).
 Verify the correct position of the connectors on PC board (see
chapter 10.14.18 on page 475).
 When switching on the device, check the operating status indicator
and LEDs on the monitor front.
 Insert a ServiceCard to test the card reader.
A T will be displayed in the status bar.
 Consecutively press and hold the Audio Paused, Blood System
Start and Blood System Stop buttons until the target point appears
at the upper left of the screen.
 Calibrate the touch screen.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.9.7 Removing and installing the screen with mounting frame

Note
Monitor can be destroyed by wrong voltage
 Check the solder bridges of PCB LP 1104 against the compatibility
matrix (see chapter 10.9.4.2 on page 305).
 Only do this with the device switched off (without the solder bridges,
voltage supply is 24 V).

Note
Monitor can malfunction if connected with wrong cables
 Only use the supplied wiring for the screen and the backlight (see
chapter 10.9.4.2 on page 305).

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X_SCREEN_SENS

R65 DR19
R17
R55
R53

R58
T3
Removal:
R56
1

T4
R61
R8
R59
T2

2
R60

2
1
D1

X6_BACKLIGHT
C62
RL1 X3_LVDS

1
3  Open the monitor (see chapter 10.9.2 on
C57

RL3
R30
1

2
R29

page 298).
D9

4
X1_EXT/IO

X10_DISPLAY
T6

T7

R44 R45
R43
R66
R42

R67 R64 R48

C29
1
2

5
R15 R49
R72

R50

 Remove the monitor front with screen (see

R14
IC2

R16
R13
R12
C14 R69
DR12

DR3
DR9
DR7
DR5
DR4

1
DR15

C15

chapter 10.9.5 on page 305).

R24
C60
DR16
DR11
DR10

6
DR6
DR1
DR8
DR2

C13
R63
C5

R27
D13
1

C25
IC8

X7
C56

XCPU2

R23
C61

R36 R28
C22
IC9

 Place the monitor front with screen on a

R31
R37 R32
R20
C55
C12

R46

C23 C11
C44

D11 R10
R38
D7
R39 R40

clean surface.
a
8

D8
R19
T1

IC7
C24
R26

D12 R11
R54

C53

IC4
 Remove the following connectors/foil
C36 +
cables from PCB LP 1145:
C21

C39
C35
C34

R6 R9 R71
C38 R70
DR17

R3 R5 C37

– Connector X_SCREEN_SENS (1)

C2 R7
C32

C41
C19

R1
IC5
R22

R57
X2_LS/MIC
DR18
C10R21
R4

R68
C31

C33
IC1
P1

C59
C28

DR14

– Connector X3_LVDS (2)

C1
1
R2

C58

– Connector X6_BACKLIGHT (3)

DMC

– Connector X10_DISPLAY (4)

– Connector XCPU2 (6)
7
– Foil cable X5 (7)
DR30
DR22
DR25
DR26
DR23
DR31
R73

8
DR33

– Foil cable X9 (8)

DR35
DR34
DR21
DR32
DR27
DR28
DR24
DR29

1 1

X9 X5
MXJ

 Disconnect connector X32 (5) from the PC

board.

9
 Pull the PCB LP 1131 cable (9) out of the
10 mounting frame (10).
 Unscrew the 4 screws (11) to remove the
monitor front and screen with mounting
frame.
 Remove the screen with the mounting
frame.
11

 Pull the PCB LP 1150 cable (12) out of the

mounting frame.
12
 Remove the screw (13).
13
 Remove PCB LP 1150 (14) with the mask.
 Remove the PC board and the PCBs
LP 1104, LP 1145 and LP 1202-3 from
14
the mounting frame.

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Installation:
 Perform the installation in reverse logical
  order.
 Reposition the mounting clips of the circuit
boards, if necessary.
 Clean the screen and the monitor front
with an antistatic cloth.
 Screw in the screws in the order shown (
to ).
 Refer to the monitor compatibility matrix
(see chapter 10.9.4.2 on page 305).
 

 Route the cable to PCB LP 1131 through

the guide slots (15).
 Fasten the ferrite (16) to the mounting
frame with a cable tie.

15

16

Calibration/testing:
 Read the material abbreviation (17) on the
17
monitor front.
 Read the material abbreviation (18) on the
monitor rear.
 Make sure that the monitor front and
monitor rear are made of the same
material. Mixing of material types is not
permitted.
18
 If necessary: Replace monitor front or
monitor rear with support arm.
Material abbreviations:
– ABS: Material STAREX ABS VE-0856.
– PC+ABS-GB: Material PC ABS Romiloy.

 Verify the correct position of the connectors on PCB LP 1104 (see

chapter 10.14.1 on page 449).

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 Verify the correct position of the connectors on PCB LP 1145 (see

chapter 10.14.11 on page 465).
 Verify the correct position of the connectors on PC board (see
chapter 10.14.18 on page 475).
 When switching on the device, check the operating status indicator
and LEDs on the monitor front.
 Insert a ServiceCard to test the card reader.
A T will be displayed in the status bar.
 Consecutively press and hold the Audio Paused, Blood System
Start and Blood System Stop buttons until the target point appears
at the upper left of the screen.
 Calibrate the touch screen.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.9.8 Removing and installing the monitor rear with monitor support arm

Note
Monitor can be destroyed by wrong voltage
 Check the solder bridges of PCB LP 1104 against the compatibility
matrix (see chapter 10.9.4.2 on page 305).
 Only do this with the device switched off (without the solder bridges,
voltage supply is 24 V).

Note
Monitor can malfunction if connected with wrong cables
 Only use the supplied wiring for the screen and the backlight (see
chapter 10.9.4.2 on page 305).

1
Removal:
2
 Open the monitor (see chapter 10.9.2 on
page 298).
3  Remove the monitor front with screen (see
4 chapter 10.9.5 on page 305).
 Remove the microphone (1).
 Remove the loudspeaker (2).
 Remove PCB LP 1134 (3).
 Remove the cable holder (4).

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 Open both side panels (see

chapter 10.6.9 on page 291).
 Squeeze the holder of the PCB cover (5)
with pliers.
5
 Remove the PCB cover (5).

 Remove the 2 screws (6).

 Pull off the connector of the protective
earth conductor (7) of the monitor.
6
 Disconnect the following connectors from
PCB LP 1142 (8):
– X_1145
– X_LAN
 If necessary, remove the cable tie.

 Open the EBM (see chapter 10.11.2 on

page 328).
 Disconnect the X2 connector (9) from
PCB LP 1106.
9

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10  Remove the power supply unit (see

chapter 10.10.2 on page 318).

11  Remove the screw (10).

 Remove the screw (11) from the
protective earth conductor.
12
 Remove the 2 screws (12) from the
monitor support arm as necessary.

 Lift and remove the monitor rear with the

monitor support arm.

Installation:
 Perform the installation in reverse logical
order.
13  Lubricate the O-ring (13) with UNISILKON
L 250 L grease.
 Position the O-ring (13) correctly.

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14  Apply a drop of Loctite 243 threadlocker

onto the screw (14).

15  Place the washer onto the screw (14).

 Screw in the screw (14).
 Place the following components onto the
screw (15) in the order given:
– Washer
– Ring cable lug of the protective earth
conductor
– Toothed washer
 Screw in the screw (15).

16  Place the following components onto the

screw (16) in the order given:
– Washer
– Cable clamp
17 – Ring cable lug of the protective earth
conductor
– Toothed washer
 Screw in the screw (16).
18

 Place the washer onto the screw (17).

 Screw in the screw (17).
 Push the protective earth conductor connector (18) of the monitor
back on.
 Check and/or adjust all monitor axes (see chapter 10.9.3 on
page 299).
 Transfer the labels from the monitor, if necessary.
 Refer to the monitor compatibility matrix (see chapter 10.9.4.2 on
page 305).

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Calibration/testing:
 Read the material abbreviation (19) on the
19
monitor front.
 Read the material abbreviation (20) on the
monitor rear.
 Make sure that the monitor front and
monitor rear are made of the same
material. Mixing of material types is not
permitted.
20
 If necessary: Replace monitor front or
monitor rear with support arm.
Material abbreviations:
– ABS: Material STAREX ABS VE-0856.
– PC+ABS-GB: Material PC ABS Romiloy.

 Verify the correct position of the connectors on PCB LP 1104 (see

chapter 10.14.1 on page 449).
 Verify the correct position of the connectors on PCB LP 1142 (see
chapter 10.14.10 on page 462).
 Verify the correct position of the connectors on PCB LP 1145 (see
chapter 10.14.11 on page 465).
 Verify the correct position of the connectors on PC board (see
chapter 10.14.18 on page 475).
 When switching on the device, check the operating status indicator
and LEDs on the monitor front.
 Insert a ServiceCard to test the card reader.
A T will be displayed in the status bar.
 Consecutively press and hold the Audio Paused, Blood System
Start and Blood System Stop buttons until the target point appears
at the upper left of the screen.
 Calibrate the touch screen.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).

 Also check the protective earth resistance

once on the monitor support arm (21).
21
 Perform the T1 test (see chapter 10.3.1 on
page 268)
 Measure the device leakage current (see
chapter 10.3.4 on page 273).

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10.10 Power supply unit and power supply cord

10.10.1 Removing and installing the power supply cord

Removal:
 Switch off the power switch (1).
 Unplug the power plug.
2
 Loosen the screw (2).
 Remove the power supply cord.
Installation:
 Insert the power supply cord.
1
 Secure the power supply cord with the
screw (2).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.10.2 Removing and installing the power supply unit

Warning
Risk of injury as a result of an electric shock
Touching live parts will cause an electric shock.
 Unplug the power plug before opening the power supply unit.

Two different power supply units can be installed in the device; they can
be identified by the serial number.
– Power supply unit with serial number section WMT
– Power supply unit with serial number section VMA

Characteristic Power supply unit with serial Power supply unit with serial
number section WMT number section VMA

Permitted software version ≥ 2.45 All

Printed circuit boards PCB LP 1186 and PCB LP 1187 PCB LP 1105-1

Battery Lithium battery CR 2032 Lithium battery CR 1225

(3 V/230 mAh) (3 V/42 mAh)

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Characteristic Power supply unit with serial Power supply unit with serial
number section WMT number section VMA

Battery replacement interval Replace every ten years. Replace every four years.

Service cover for easier battery No Option

change

Residual-current device Option Option

Removal:
 Open both side panels (see
chapter 10.6.9 on page 291).
 Unplug the power plug.
 Remove the power supply cord (see
1 chapter 10.10.1 on page 318).
 Loosen the 2 screws on the fixing bracket
(1).
 Unplug the heater rod connector.

 Open the EBM.

 Remove the 3 M4x8 screws (2) from
PCB LP 1106.
 Place PCB LP 1106 in the device.

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 Unplug the protective earth conductor

connector (3) of the power supply unit
from the equipotential bonding connection
on the left side of the hydraulic assembly.
3

 Unscrew the 3 screws (4) from the power

supply unit.
 Push the power supply unit forward,
toward the front of the EBM, then remove
it.

Installation:
 Perform the installation in reverse logical
order.
5
 Plug in the protective earth conductor
connector (5) connector of the power
supply unit into the equipotential bonding
connection on the left side of the hydraulic
assembly.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

Note
After replacement of the power supply unit, its software version must be
updated as necessary.

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10.10.3 Removing and installing the power plug fuse (UK version only)

Power plug fuse, UK T 13 A, 240 V (according to BS1362)

version

Removal:
 Lift the fuse cover (1) at the side using a
1 screwdriver (2).
 Remove the fuse cover (1).

 Prise the fuse (3) out of the fuse holder

using a screwdriver.

3  Remove the fuse (3).

Do not lift the fuse by the glass/ceramic body,
as the fuse may break.

Installation:
 Install in reverse order.

Final tasks No final tasks needed.

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10.11 Extracorporeal Blood Circuit Module (EBM)

10.11.1 Door

10.11.1.1 Replacing the screw protection caps

Removal:
 Use a small Phillips screwdriver to pierce
through and pry out the screw protection
1 cap (1).
While doing so, prevent damaging the
anodizing.
Installation:
 Insert the new screw protection cap.

Final tasks No final tasks needed.

10.11.1.2 Removing and installing the design hood

Removal:
 Remove the 5 screw protection caps.
 Remove the 5 screws (1).
 Remove the design hood (2).

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Installation:
 Push the cover of the door unlocking
mechanism (3) outward from the inside in
order to position the cover correctly.
3
 Mount the design hood (2) with 5 screws
(1).
Specified wrench torque of the 5 screws (1):
230 Ncm
 Make sure the pneumatic tubings are not
trapped.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Insert the new screw protection caps.

10.11.1.3 Removing and installing the door bolt

Removal:
 Remove the design hood.
 Remove the screw (1) with washer.
1
2  Remove the push knob (2).
 Remove the door bolt (3) with spring.
3
Use tweezers if necessary.

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Installation:
 Insert the spring.
 Insert the door bolt (3) as shown.
 Insert the push knob (2).
 Press and hold down the push knob (2).
3
 Screw in the screw (1) with washer.
 Mount the design hood.
Check:
 Check that the door unlocking mechanism
moves smoothly.

 Check status of the door detector (4) in the

EBM Flow Diagram.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.11.1.4 Removing and installing the cassette deaeration port/Single-Needle port or cassette coupling
port

Fig.: Door ports in a device with Single-Needle (option)

Legend:
1 1 Cassette deaeration port/Single-Needle
port
2 Cassette coupling port

Removal:
 Cut off the pneumatic tubing (3) directly at
the adapter of the door port being
replaced.

 Remove the adapter (4) using a socket

wrench (size 10).

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 Push the door port (5) out of the door in

the direction of the arrow using a blunt
implement.
5
 Remove the door port (5).
 Dispose of the old O-ring and old port
seal.
Used seals must not be reused.

Installation:
 Apply a thin layer of BARRIERTA L55/1
grease to the new O-ring (6) before fitting
6
it.
 Apply a thin layer of BARRIERTA L55/1
grease to the new port seal (9) at the area
shown before fitting it.
 Assemble the door port in the sequence
7 and orientation shown. When carrying out
this work, ensure the following:
– The air channel (7) is free of grease.
– The plastic washer (8) and the port
seal (9) are compatible with each
other.
8 – The ridge on the plastic washer (8) is
aligned with the groove on the port seal
(9).

9
 Insert the door ports into the door and
manually press in until they stop.

 Screw in the adapter (10) using a socket

wrench (size 10).
Specified wrench torque for the adapter (10):
10 350 Ncm
 Continue installing in reverse logical
order.

Check in case of cassette  Perform the pneumatics test (see chapter 9.5.3.1 on page 241).
coupling port

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Check in case of cassette  Perform the Single-Needle pneumatics test (option) (see
deaeration port / Single- chapter 9.5.3.2 on page 243).
Needle port

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.1.5 Removing and installing PCB LP 1179 LED board

Removal:
 Remove the design hood.
1
 Lay the tubing (1) so that PCB LP 1179 (2)
can be removed.
6 2
5  Detach the condensate separator (3) from
4 the door as necessary.

3  Unlock the 3 PCB holders (4) using a pair

of long-nose pliers.
 Unplug connector X_DOOR2 (5) from
PCB LP 1179 (green line).
 Unplug connector X_DOOR1 (6) from
PCB LP 1179 (blue line).
 Remove PCB LP 1179 (2).

Installation:
 Perform the installation in reverse logical
order.
Check:
 Switch the device on.
7
 Make sure the 3 LEDs (7) light up briefly.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.11.2 Opening and closing the EBM

Warning
Risk of crush injury due to the movable EBM door hinge
 Never reach through the EBM door hinge.
 If work must be carried out behind the EBM door hinge, first open the
EBM.

Opening the EBM:

 Close the door.
 Open the EBM lock (1) on the left side of
the device.
 Carefully tilt the EBM forward.
1 Closing the EBM:
 Carefully close the EBM.
 Ensure that the pull cord and cables are
not trapped.
 Ensure that the tubings are not trapped or
kinked.
 Close the EBM lock (1) on the left side of
the device.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.3 Removing and installing the EBM

Warning
Risk of crush injury due to the movable EBM door hinge
 Never reach through the EBM door hinge.
 If work must be carried out behind the EBM door hinge, first open the
EBM.

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Removal:
 Open the EBM lock on the left side of the
device.
 Open the EBM.
 Open both side panels (see
chapter 10.6.9 on page 291).
1 There is a risk of injury to body parts from the
door hinge (1) when opening the EBM.
 Never reach through the door hinge (1).

 Detach the cover from the electronics

chassis in the hydraulics.
 Unplug connector X_S29_S30 (2) from
PCB LP 1140 and pull out the cable.
2

 Open the electronics plate in the EBM.

 Unplug the power supply connector (3)
3 from PCB LP 1178.
 Unplug the CAN cable connector (4) from
4 PCB LP 1178.
 Remove the cable from the holder (5).

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 Unplug the connector of the protective

earth cable (6) and pull out the cable.

 Unplug the connectors from the following

valves and pull out the cables:
– Valve V42 (7)
– Valve V43 (8)
7
– Valve V32 (9)
– Valve V31 (10)
12 – Valve V33 (11)
 Detach and pull out the drain tubing of the
substituate unit (12).

9
10
11

 Clamp the tubing (13).

 Detach the tubing (13) from valve V32.
13

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 Clamp the tubing (14).

 Detach the tubing (14) from valve V31.
14
 Remove the tubings from the holder.

 Loosen the wire tube clamp (15).

 Detach the white tubing from the
emergency unlocking valve.

15

16  Cut off the pneumatic tube of the positive

pressure vessel (16) directly at the
adapter fitting.
 Cut off the pneumatic tube of the negative
17 pressure vessel (17) directly at the
adapter fitting.
 Loosen the wire tube clamp and pull off
18 the blue tubing (18).
 Remove the tubings from the holder.

 Close the electronics plate in the EBM.

 Remove the lock (19) from the hinges.

19

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 Hold the EBM firm.

The hinge mounting mechanism may break if
20
the full weight of the EBM rests on the hinges.
 Loosen the screw (20) of the pull cord.
21  Pull out the pull cord holder (21).

 With the aid of a second person, lift the

EBM to take it off its hinges.

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Installation:
 Perform the installation in reverse logical
order.
The hinges must be folded out.
 Insert the lock (23) as shown (the metal
23 bush is inserted from inside).
 Ensure that the pull cord and cables are
not trapped.
 Ensure that the tubings are not trapped or
kinked.
 Lay the drain tubing of the substituate unit
with a uniform gradient down to the
leakage sensor, to avoid creating a trap.

Check  Switch the device on and wait until the system compressor is no
longer active (see chapter 9.3 on page 224).
 Wait for a stabilization time of 5 minutes.
The system compressor may not become active while this time is
elapsing.
 Note down the positive and negative pressure values from the EBM
Flow Diagram.
 Wait until the measuring time of 2 minutes has elapsed.
 Note down the positive and negative pressure values again.
The device is pneumatically tight if the positive pressure decreases by
no more than 79 mbar and the negative pressure rises by no more than
10 mbar during the measuring time.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.11.4 Replacing the pneumatic tubings in the EBM

Note
The barbed fittings may be damaged when the pneumatic tubing is
removed.
Damaged barbed fittings may cause leaks.
 Remove the pneumatic tubing without damaging the barbed fitting.

Disconnecting the pneumatic tube:

 Use diagonal cutters with a straight and
undamaged blade for disconnecting the
pneumatic tubing.
 Using the diagonal cutters, carefully clip
off a piece along the longitudinal axis.
 Make sure you avoid applying the
diagonal cutters too deeply.

 Pull the tubing away from the barbed

fitting (1).

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Note
Damage to the tubing
The tubing must not be kinked during installation. Once kinked, tubings
show the first signs of damage and will cause leakages.
 Only use tubings that are not kinked.

Connecting the pneumatic  Cut the tubing at a right angle using the diagonal cutters.
tube
 Slot the tubing rapidly and fully onto the barbed fitting.

Check  Perform the pneumatics test (see chapter 9.5.3.1 on page 241).

Additionally with  Perform the Single-Needle pneumatics test (option) (see

Single-Needle (option) chapter 9.5.3.2 on page 243).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.5 Removing and installing the arterial occlusion clamp

1 Removal:
2
 Open the EBM (see chapter 10.11.2 on
page 328).
 Unplug the connector of the protective
4 earth conductor (1).
3
 Take the white and blue tubings and the
protective earth conductor out of the
holder (2).
 Unplug connector V31 (3).
 Loosen the screws (4).
 Detach valve block V31/V32/V33/V43.

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5  If the BVM (option) is fitted, also do the

following:
1. Detach the cable from the holder (5).

6 2. Remove the screw (6).

3. Open the BVM (option) a little way.
4. Unplug the CAN bus connector (7).
7
5. Unplug the ribbon cable connector (8).
8 6. Open out the BVM (option) completely.

 Pull off the protective earth conductor (9).

9  Unplug the connector of the arterial
occlusion clamp.
 In order to open the locking mechanism,
press the spring (10) outwards using a
screw driver.
 Turn the arterial occlusion clamp
10 counterclockwise.

11 Installation:
 Perform the installation in reverse logical
12 order.
 Lubricate the seal with UNISILKON L 250
L grease.
 Push the protective earth conductor (9)
back on until it clicks into place.
13  Check the arterial occlusion clamp for
damage at the following points:
– Catch (11)
– Valve tappet (12)
– Clamping and tappet surfaces (13)

 Push back the catch.

A distinct counterpressure must be felt.
 Release the catch.
The tappet returns to its starting position.

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Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the EBM T1 test (see chapter 10.3.2 on page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.6 Removing and installing the venous occlusion clamp

1 Removal:
2
 Open the EBM (see chapter 10.11.2 on
page 328).
 Unplug the connector of the protective
4 earth conductor (1).
3
 Take the white and blue tubings and the
protective earth conductor out of the
holder (2).
 Unplug connector V31 (3).
 Loosen the screws (4).
 Detach valve block V31/V32/V33/V43.

5  If the BVM (option) is fitted, also do the

following:
1. Detach the cable from the holder (5).

6 2. Remove the screw (6).

3. Open the BVM (option) a little way.
4. Unplug the CAN bus connector (7).
7
5. Unplug the ribbon cable connector (8).
8 6. Open out the BVM (option) completely.

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 Pull off the protective earth conductor (9).

9  Unplug the connector of the venous
occlusion clamp.
 In order to open the locking mechanism,
press the spring (10) outwards using a
screw driver.
 Turn the venous occlusion clamp
10 counterclockwise.

11 Installation:
 Perform the installation in reverse logical
12 order.
 Lubricate the seal with UNISILKON L 250
L grease.
 Push the protective earth conductor (9)
back on until it clicks into place.
13  Check the venous occlusion clamp for
damage at the following points:
– Catch (11)
– Valve tappet (12)
– Clamping and tappet surfaces (13)

 Push back the catch.

A distinct counterpressure must be felt.
 Release the catch.
The tappet returns to its starting position.

14 Checking the venous occlusion clamp:

15  Leave dialyzer couplings in the shunt

16 interlock.
 Insert a dry cassette system as shown.
 Remove all caps from the cassette
system.
17  Tighten the arterial and venous patient
connections on the rinse connector.
 Connect the rinse connector to the rinse
port (14) and close the rinse port (14).
18  Close the arterial insertion site (15).
 Close the door.
19
 In the BLOOD SYSTEM menu, select the
Lock door field.

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 Connect the venous dialyzer connector to the reference meter (16)

using the long tube adapter (17).
 Insert the venous line (18) in the venous occlusion clamp.
 Make sure the arterial dialyzer connector (19) is open to
atmosphere.
 Use the syringe to build up a pressure of approximately 280 mmHg.
 Leave the cassette system in the closed venous occlusion clamp for
at least 1 minute at a temperature of approximately 20 °C.
Pressure build-up – arterial side:
 Open the venous occlusion clamp manually, and hold it open.
 Wait until the value has stabilized.
 Check and record the arterial pressure in the EBM Flow Diagram.
Target value: 50 mmHg to 150 mmHg
 Release the venous occlusion clamp.
The venous occlusion clamp closes.
Pressure build-up – venous side:
 Use the syringe to build up a pressure of 1875 mmHg to
2025 mmHg.
 Wait until the value has stabilized.
 Record the value of the external reference meter.
 Wait 3 minutes.
After 3 minutes:
 Check the arterial pressure in the EBM Flow Diagram.
Target value: recorded value of arterial pressure ±5 mmHg
 Check the value of the external reference meter.
Target value: value recorded by external reference meter –75 mmHg
 Remove the rinse connector from the rinse port.
 Close the rinse port.
 In the BLOOD SYSTEM menu, select the Remove lines field.
 Remove the cassette system.
 Remove any external test equipment.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the EBM T1 test (see chapter 10.3.2 on page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.11.7 Resetting the zero point of the pressure transducers (EBM)

Requirement The device is switched off.

Zero point of the pressure  Switch the device on.

transducers (EBM),
 Make sure the EBM T1 test is completed successfully after the
resetting
device has been switched on.
 Wait for Standby state.
 Start the T1 test.
 Insert the cassette system and close the door.
 Select the Lock door field.
The door is subjected to pressure. Then the following pressure
transducers are automatically reset:
– Arterial pressure transducer
– Venous pressure transducer
– Single-Needle pressure transducer
– Pre-filter pressure transducer
The zero point of the pressure transducers has been successfully reset
if no message indicating a problem is displayed.

Final tasks No final tasks needed.

10.11.8 Measuring the zero points of the pressure transducers (EBM)

Requirement The device is switched off.

Check  Switch the device on.

 Start the T1 test (see chapter 10.3.1 on page 268).

1  Leave dialyzer couplings in the shunt

interlock.
2
 Insert a dry cassette system as shown.
3
 Remove all caps from the cassette
system.
 Tighten the arterial and venous patient
connections on the rinse connector.
4  Connect the rinse connector to the rinse
port (1) and close the rinse port (1).
 Close the arterial insertion site (2).
 Close the door.
 In the BLOOD SYSTEM menu, select the
5 Lock door field.
The door is locked and the cassette system is
connected.

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 Connect the venous dialyzer connector to the reference meter (3)

using the long tube adapter (4).
 Make sure the arterial dialyzer connector (5) is open to atmosphere.
 Check the status display of the cassette coupling sensor in the EBM
Flow Diagram.
Target value: Status indicator lights up green.
 Wait five seconds. This ensures that enough measurements are
available for the averaged values.
 Check the arterial pressure in the EBM Flow Diagram.
Target value: 0 mmHg ±5 mmHg
 Check the venous pressure in the EBM Flow Diagram.
Target value: 0 mmHg ±5 mmHg
 Check the pre-filter pressure in the EBM Flow Diagram.
Target value: 0 mmHg ±5 mmHg
 Remove the cassette system.
 Remove any external test equipment.

Final tasks No final tasks needed.

10.11.9 Removing and installing the substituate unit

Removal:
 Switch off the device.
 Open the EBM.
1
 Open the electronics plate.

2
 Protect components from leaking fluid.

3
 Unplug the ribbon cable (1).
 Loosen the 3 wire tube clamps (2) and pull
off the tubings.
 Pull off the drain tubing (3).

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 Loosen the 3 screws (4).

 Remove the substituate unit.

Installation:
 Perform the installation in reverse logical
order.
5  Push the connector of the ribbon cable (5)
6
onto its header.
7
8  Attach the following tubings to their
9
respective positions on the substituate
unit and secure them with wire tube
clamps:
– White tubing to V42 (6) on W
– Blue tubing to V31 (7) on V31
– Blue tubing to V43 (8) to B
 Attach the drain tubing (9).
 Lay the drain tubing of the substituate unit
with a uniform gradient down to the
leakage sensor, to avoid creating a trap.

 Align the tube clamps (10) as shown in the

illustration.

10

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 Lay the blue tubings (11) so they can

move freely as shown.

11

 Correctly insert the cassette contact mat

near the substituate unit (12) with the
removal tool for O-rings.

12

Note
Defect in substituate unit due to incorrect calibration values
The substituate unit must not be activated until the correct calibration
values have been entered. This also applies if the calibration values of
the new substituate unit are identical to those of the old substituate unit.
 Open the door so the substituate unit cannot be activated.

Calibration/testing:
 Switch the device on and wait until the
system compressor is no longer active
(see chapter 9.3 on page 224).
13
 Check that the pneumatics negative
pressure (13) displayed in the EBM Flow
Diagram is stable.

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 Ensure that the cassette contact mat is

still correctly seated at the marked
positions after the negative pressure has
been created.
Example pictures of improperly installed
cassette contact mats (see chapter 10.15.3
on page 484).
 Calibrate the substituate unit (see
chapter 9.4.11 on page 237).
 Select the DIAGNOSTICS  Hydraulics
 Test menu.
 Select the Substituate unit  Move to
service pos. field.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

10.11.10 Actuator-sensor unit

10.11.10.1 Removing and installing the cassette contact mat

Note
Malfunction of the actuator-sensor unit due to dirt particles
 Check the rear of the new cassette contact mat for contamination.
 If necessary, clean the rear of the new cassette contact mat using a
lint-free cloth with no cleaning agent.
 Install the new cassette contact mat immediately after removing the
old one.

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Removal:
 Open the EBM.
 Open the electronics plate.
 Loosen the 8 screws (1).

 Detach the cassette contact mat (2).

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Chapter 10: Servicing/repair

 Remove the frame (3).

Installation:
 Lightly grease the sealing groove (4) of
the actuator-sensor unit with POLYLUB
GLY151 using a Texwipe swab.
 Ensure that the air channels and cassette
4 sensors are free of grease.
Too much grease could clog the air channels
of the actuator-sensor unit or impair the
functioning of the cassette sensors.

5
6  Pull the outer seal (5) of the cassette
contact mat over the lip (6) around the
frame.

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 Chapter 10: Servicing/repair

 Insert the cassette contact mat together

with the frame on the cassette positioning
pins (7).

7  Push the cassette contact mat evenly into

the sealing groove at the marked position.
 Screw the frame into place using the
8 screws provided. This prevents the
frame from being damaged by unsuitable
screws.
Specified wrench torque for the 8 screws:
90 Ncm
 Close the electronics plate.
 Close the EBM.

 Correctly insert the cassette contact mat

near the substituate unit (8) with the
removal tool for O-rings.

 Press down the cassette contact mat

evenly at the marked positions.

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Chapter 10: Servicing/repair

Calibration/testing:
 Switch the device on and wait until the
system compressor is no longer active
(see chapter 9.3 on page 224).
9
 Check that the pneumatics negative
pressure (9) displayed in the EBM Flow
Diagram is stable.

 Ensure that the cassette contact mat is

still correctly seated at the marked
positions after the negative pressure has
been created.
Example pictures of improperly installed
cassette contact mats (see chapter 10.15.3
on page 484).
 Check the Installation altitude field in the
SETUP  Settings Hydraulics menu.
 Calibrate the cassette sensors (see
chapter 9.4.12 on page 238).

 Perform the pneumatics test (see chapter 9.5.3.1 on page 241).

 Perform the Single-Needle pneumatics test (option) (see
chapter 9.5.3.2 on page 243).
 Measure the zero point of the pressure transducers (EBM) (see
chapter 10.11.8 on page 340).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.11.10.2 Removing and installing the temperature sensor

1 Removal:

2
 Switch off the device.
 Open the EBM.
 Open the electronics plate.
 Unplug the connector (2) of the
temperature sensor (1).
 Unscrew and remove the temperature
sensor.

Installation  Perform the installation in reverse logical order.

Calibration No calibration required.

Check:
3
 Check that the temperature value (3)
displayed in the EBM Flow Diagram is
plausible.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.10.3 Removing and installing the supports of the cassette contact mat

Note
Malfunction of the actuator-sensor unit due to dirt particles
 Check the rear of the new cassette contact mat for contamination.
 If necessary, clean the rear of the new cassette contact mat using a
lint-free cloth with no cleaning agent.
 Install the new cassette contact mat immediately after removing the
old one.

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Chapter 10: Servicing/repair

Removal:
 Switch off the device.
 Open the EBM.
1.4 mm
 Remove the cassette contact mat (see
chapter 10.11.10.1 on page 344).
1  Remove the two upper 1.4 mm supports
2 (1) using the mounting aid.
 Remove the single lower 1.2 mm support
(2) using the mounting aid.
1.2 mm

Installation  Perform the installation in reverse logical order.

 Tighten the supports a little using the mounting aid.
 Install the cassette contact mat (see chapter 10.11.10.1 on
page 344).

Calibration/testing:
 Switch the device on and wait until the
system compressor is no longer active
(see chapter 9.3 on page 224).
3
 Check that the pneumatics negative
pressure (3) displayed in the EBM Flow
Diagram is stable.

 Ensure that the cassette contact mat is

still correctly seated at the marked
positions after the negative pressure has
been created.
Example pictures of improperly installed
cassette contact mats (see chapter 10.15.3
on page 484).
 Check the Installation altitude field in the
SETUP  Settings Hydraulics menu.
 Calibrate the cassette sensors (see
chapter 9.4.12 on page 238).

 Perform the pneumatics test (see chapter 9.5.3.1 on page 241).

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 Perform the Single-Needle pneumatics test (option) (see

chapter 9.5.3.2 on page 243).
 Measure the zero point of the pressure transducers (EBM) (see
chapter 10.11.8 on page 340).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the EBM T1 test (see chapter 10.3.2 on page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.10.4 Removing and installing level detector

Note
Malfunction of the actuator-sensor unit due to dirt particles
 Check the rear of the new cassette contact mat for contamination.
 If necessary, clean the rear of the new cassette contact mat using a
lint-free cloth with no cleaning agent.
 Install the new cassette contact mat immediately after removing the
old one.

Legend:
1 Single-Needle level detector (option)
1
2 Venous bubble catcher level detector
3
Removal:
 Remove the cassette contact mat (see
2 chapter 10.11.10.1 on page 344).
 Unplug the connector (3) of the level
detector being replaced.

 Press the spring (4) of the level detector

being replaced inward.

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Chapter 10: Servicing/repair

 Press the level detector being replaced (5)

outward through the actuator-sensor unit.

5  Remove the level detector being replaced

(5).

Installation:
 Perform the installation in reverse logical
order.
6
 Grease the O-ring (6) on the new level
detector with UNISILKON L 250 L grease.
 Position the O-ring (6) as shown.
 Install the cassette contact mat (see
chapter 10.11.10.1 on page 344).

Calibration/testing:
 Switch the device on and wait until the
system compressor is no longer active
9 (see chapter 9.3 on page 224).
7
8  Check that the pneumatics negative
pressure (7) displayed in the EBM Flow
Diagram is stable.
 If the venous bubble catcher level detector
(8) has been changed, place a finger on
the level detector and check its status in
the EBM Flow Diagram.
 If the Single-Needle level detector (option)
(9) has been changed, place a finger on
the level detector and check its status in
the EBM Flow Diagram.

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 Ensure that the cassette contact mat is

still correctly seated at the marked
positions after the negative pressure has
been created.
Example pictures of improperly installed
cassette contact mats (see chapter 10.15.3
on page 484).
 Check the Installation altitude field in the
SETUP  Settings Hydraulics menu.
 Calibrate the cassette sensors (see
chapter 9.4.12 on page 238).

 Perform the pneumatics test (see chapter 9.5.3.1 on page 241).

 Perform the Single-Needle pneumatics test (option) (see
chapter 9.5.3.2 on page 243).
 Measure the zero point of the pressure transducers (EBM) (see
chapter 10.11.8 on page 340).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.10.5 Removing and installing the cassette coupling sensor

Note
Malfunction due to different cassette sensors
 Only install cassette sensors of the same type in the device.
 Set jumper J1 on PCB LP 1178 depending on the type of cassette
sensor used (see chapter 10.14.13 on page 468).
 Mount the cassette sensors using the specified screw.

Cassette sensor type Hund Jenoptik

Permitted PCBs PCB LP 1178, SP index: ≥ g PCB LP 1178, SP index: all

Illustration

Housing color Black Transparent

Specified screw M3x18 M3x10

Jumper J1 (see chapter 10.14.13 on page 468)

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Chapter 10: Servicing/repair

Removal:
 Open the EBM.

1  Open the electronics plate.

2  Unplug the connector of the cassette

3
coupling sensor (1).
 Loosen the screw (2).
 Remove the cassette coupling sensor (3)
using flat pliers.

Installation  Perform the installation in reverse logical order.

 Using flat pliers, insert the cassette sensor until it stops.
 Carefully tighten the screw (2).
Specified wrench torque for the cassette sensor (2): 60 Ncm

Calibration/testing:
 Switch the device on and wait until the
system compressor is no longer active
(see chapter 9.3 on page 224).
4
 Check that the pneumatics negative
pressure (4) displayed in the EBM Flow
Diagram is stable.

 Ensure that the cassette contact mat is

still correctly seated at the marked
positions after the negative pressure has
been created.
Example pictures of improperly installed
cassette contact mats (see chapter 10.15.3
on page 484).
 Check the Installation altitude field in the
SETUP  Settings Hydraulics menu.
 Calibrate the cassette sensors (see
chapter 9.4.12 on page 238).

 Perform the pneumatics test (see chapter 9.5.3.1 on page 241).

 Perform the Single-Needle pneumatics test (option) (see
chapter 9.5.3.2 on page 243).
 Measure the zero point of the pressure transducers (EBM) (see
chapter 10.11.8 on page 340).

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Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.10.6 Removing and installing the cassette detection sensors

Note
Malfunction due to different cassette sensors
 Only install cassette sensors of the same type in the device.
 Set jumper J1 on PCB LP 1178 depending on the type of cassette
sensor used (see chapter 10.14.13 on page 468).
 Mount the cassette sensors using the specified screw.

Cassette sensor type Hund Jenoptik

Permitted PCBs PCB LP 1178, SP index: ≥ g PCB LP 1178, SP index: all

Illustration

Housing color Black Transparent

Specified screw M3x18 M3x10

Jumper J1 (see chapter 10.14.13 on page 468)

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Chapter 10: Servicing/repair

Legend:
1
1 Cassette detection sensor 1
2 Cassette detection sensor 2
Removal:
 Open the EBM.
4
 Open the electronics plate.
 Unplug the connector (3) of the cassette
sensor being replaced.
 Loosen the screw (4) of the cassette
sensor being replaced.
2  Remove the cassette sensor being
replaced using flat pliers.
Installation:
 Perform the installation in reverse logical
3 order.
 Using flat pliers, insert the cassette sensor
until it stops.
 Tighten the screw (4) carefully and only a
little.
 Carefully tighten the screw (4).
Specified wrench torque for the cassette
sensor (4): 60 Ncm

Calibration/testing:
 Switch the device on and wait until the
system compressor is no longer active
(see chapter 9.3 on page 224).
5
 Check that the pneumatics negative
pressure (5) displayed in the EBM Flow
Diagram is stable.

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 Ensure that the cassette contact mat is

still correctly seated at the marked
positions after the negative pressure has
been created.
Example pictures of improperly installed
cassette contact mats (see chapter 10.15.3
on page 484).
 Check the Installation altitude field in the
SETUP  Settings Hydraulics menu.
 Calibrate the cassette sensors (see
chapter 9.4.12 on page 238).

 Perform the pneumatics test (see chapter 9.5.3.1 on page 241).

 Perform the Single-Needle pneumatics test (option) (see
chapter 9.5.3.2 on page 243).
 Measure the zero point of the pressure transducers (EBM) (see
chapter 10.11.8 on page 340).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.10.7 Removing and installing the pressure transducer

Removal:
1
 Switch off the device.
 Open the EBM.
 Open the electronics plate.

Additionally in the case of the Single-

Needle pressure transducer:
 Loosen the 1 screw (1).

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Chapter 10: Servicing/repair

Additionally in the case of the Single-

Needle pressure transducer:
 Loosen the 2 screws (2).
 Put the substituate unit to one side.

 Unplug the connector (3) of the pressure

transducer being replaced.
Pressure transducers:
4 Arterial pressure transducer
Measuring range: –700 mbar to
+700 mbar
7
5 Venous pressure transducer
Measuring range: –333 mbar to
+1000 mbar
6 Pre-filter pressure transducer
Measuring range: –133 mbar to
+1600 mbar
7 Single-Needle pressure transducer
Measuring range: –333 mbar to
+1000 mbar
3

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8  Loosen the threaded pin (8) of the

pressure transducer being replaced.

9
 Remove the pressure ring (9) of the
pressure transducer being replaced.
 Remove the pressure disk (10).
10
 Remove the old pressure transducer (11).

11
12

Installation  Perform the installation in reverse logical order.

 Ensure that a new O-ring (12) is correctly attached to the new
pressure transducer (11).
 Insert the new pressure transducer (11).
 Insert the pressure disk (10).
 Twist the threaded pin (8) back in until it is flush with the pressure
ring (9).
 Screw in the pressure ring (9).
Specified wrench torque for pressure ring (9):
350 Ncm
 Tighten the threaded pin (8).
Specified wrench torque for threaded pin (8): 230 Ncm
 Push the connector of the pressure transducer onto its header.

Calibration/testing:
 Switch the device on and wait until the
system compressor is no longer active
(see chapter 9.3 on page 224).
17
 Check that the pneumatics negative
pressure (17) displayed in the EBM Flow
Diagram is stable.

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Chapter 10: Servicing/repair

 Ensure that the cassette contact mat is

still correctly seated at the marked
positions after the negative pressure has
been created.
Example pictures of improperly installed
cassette contact mats (see chapter 10.15.3
on page 484).
 Check the Installation altitude field in the
SETUP  Settings Hydraulics menu.
 Calibrate the cassette sensors
(see chapter 9.4.12 on page 238).

18 Checking the zero point of pressure

displays:
19
 Insert a dry cassette system as shown.
20
 Remove all caps from the cassette
system.
 Tighten the arterial and venous patient
connections on the rinse connector.
21  Connect the rinse connector to the rinse
port (18) and close the rinse port (18).
 Close the arterial insertion site (19).
 Close the door.
 In the BLOOD SYSTEM menu, select the
22 Lock door field.
The door is locked and the cassette system is
connected.

 Connect the venous dialyzer connector to the reference meter (20)

using the long tube adapter (21).
 Make sure the arterial dialyzer connector (22) is open to
atmosphere.
 Check the status display of the cassette coupling sensor in the EBM
Flow Diagram.
Target value: Status indicator lights up green.
 Wait five seconds. This ensures that enough measurements are
available for the averaged values.
 Check the arterial pressure in the EBM Flow Diagram.
Target value: 0 mmHg ±5 mmHg
 Check the venous pressure in the EBM Flow Diagram.
Target value: 0 mmHg ±5 mmHg

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 Chapter 10: Servicing/repair

 Check the pre-filter pressure in the EBM Flow Diagram.

Target value: 0 mmHg ±5 mmHg

Checking the slope of pressure displays:

 Connect a syringe filled with air (23) to the
23 venous insertion line.
 Open the arterial insertion site (24).
 Connect the arterial dialyzer connector to
the arterial insertion site (24) using the
short tube adapter (25).
 Use the syringe to build up a pressure of
approximately 280 mmHg.
 Wait until the value has stabilized.
 Check the arterial pressure in the EBM
Flow Diagram.

24 Target value: built-up pressure ±10 mmHg

 Check the venous pressure in the EBM
25 Flow Diagram.
Target value: built-up pressure ±10 mmHg

 Check the pre-filter pressure in the EBM Flow Diagram.

Target value: built-up pressure ±15 mmHg
Example with ±10 mmHg:
Built-up pressure: 283 mmHg
Target value: 273 mmHg to 293 mmHg
Example with ±15 mmHg:
Built-up pressure: 283 mmHg
Target value: 268 mmHg to 298 mmHg
 Remove the rinse connector from the rinse port.
 Close the rinse port.
 In the BLOOD SYSTEM menu, select the Remove lines field.
 Remove the cassette system.
 Remove any external test equipment.

Check  Perform the pneumatics test (see chapter 9.5.3.1 on page 241).
 Perform the Single-Needle pneumatics test (option) (see
chapter 9.5.3.2 on page 243).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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Chapter 10: Servicing/repair

10.11.10.8 Removing and installing the actuator-sensor unit

Note
Malfunction of the actuator-sensor unit due to dirt particles
 Check the rear of the new cassette contact mat for contamination.
 If necessary, clean the rear of the new cassette contact mat using a
lint-free cloth with no cleaning agent.
 Install the new cassette contact mat immediately after removing the
old one.

Removal:
1
 Switch off the device.
 Open the EBM.
 Remove the cassette contact mat (see
chapter 10.11.10.1 on page 344).
 Open the electronics plate.
 Loosen the 1 screw (1).

 Loosen the 2 screws (2).

 Put the substituate unit to one side.

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 Chapter 10: Servicing/repair

 Unlock and remove the connector (3) on

the outside.
 Remove the screw (4) from the protective
earth cable.
 Cut off the pneumatic tubings (5) directly
at the adapter fitting (see chapter 10.11.4
on page 334).

5
3

 Hold the actuator-sensor unit from the

outside.
 Remove the 4 screws (6).
 Remove the actuator-sensor unit from the
outside.
 Place the actuator-sensor unit on a clean
surface.
6

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7
 Remove the following components from
8 the old actuator-sensor unit as per the
respective component descriptions and
install them in the new actuator-sensor
unit.
Temperature sensor (see
chapter 10.11.10.2 on page 349):
7 Temperature sensor
16 Cassette sensors (see chapter 10.11.10.5
on page 353) or (see chapter 10.11.10.6 on
page 355):
8 Cassette detection sensor 1
15 9 9 Cassette detection sensor 2
10 Cassette coupling
Pressure transducers (see
chapter 10.11.10.7 on page 357):
14 11 Arterial pressure transducer
12 Venous pressure transducer
10 13 Pre-filter pressure transducer
16 Single-Needle pressure transducer
13 (option)
Level detectors (see chapter 10.11.10.4 on
page 351):
14 Venous bubble catcher
12 11 15 Single-Needle (option)

Specified wrench torques:

– Cassette sensors (8) (9) (10): 60 Ncm
– Pressure transducers (11) (12) (13) (16)
– Pressure rings: 350 Ncm
– Threaded pins: 230 Ncm

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Installation:
 Perform the installation in reverse logical
order.
Specified wrench torque for the screw for the
protective earth conductor (4): 230 Ncm
 Attach all pneumatic tubings as shown in
the pneumatics overview (see
chapter 11.6.1 on page 498).
If one pneumatic tubing is too short, replace it
according to length specifications in the
pneumatics overview.
 Install the cassette contact mat (see
chapter 10.11.10.1 on page 344).

More detailed figure (see chapter 11.6.1 on page 498)

Calibration/testing:
 Switch the device on and wait until the
system compressor is no longer active
(see chapter 9.3 on page 224).
17
 Check that the pneumatics negative
pressure (17) displayed in the EBM Flow
Diagram is stable.

 Ensure that the cassette contact mat is

still correctly seated at the marked
positions after the negative pressure has
been created.
Example pictures of improperly installed
cassette contact mats (see chapter 10.15.3
on page 484).
 Check the Installation altitude field in the
SETUP  Settings Hydraulics menu.
 Calibrate the cassette sensors (see
chapter 9.4.12 on page 238).

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18 Checking the zero point of pressure

displays:
19
 Insert a dry cassette system as shown.
20
 Remove all caps from the cassette
system.
 Tighten the arterial and venous patient
connections on the rinse connector.
21  Connect the rinse connector to the rinse
port (18) and close the rinse port (18).
 Close the arterial insertion site (19).
 Close the door.
 In the BLOOD SYSTEM menu, select the
22 Lock door field.
The door is locked and the cassette system is
connected.

 Connect the venous dialyzer connector to the reference meter (20)

using the long tube adapter (21).
 Make sure the arterial dialyzer connector (22) is open to
atmosphere.
 Check the arterial pressure in the EBM Flow Diagram.
Target value: 0 mmHg ±5 mmHg
 Check the venous pressure in the EBM Flow Diagram.
Target value: 0 mmHg ±5 mmHg
 Check the pre-filter pressure in the EBM Flow Diagram.
Target value: 0 mmHg ±5 mmHg

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Checking the slope of pressure displays:

 Connect a syringe filled with air (23) to the
23 venous insertion line.
 Open the arterial insertion site (24).
 Connect the arterial dialyzer connector to
the arterial insertion site (24) using the
short tube adapter (25).
 Use the syringe to build up a pressure of
approximately 280 mmHg.
 Wait until the value has stabilized.
 Check the arterial pressure in the EBM
Flow Diagram.

24 Target value: built-up pressure ±10 mmHg

 Check the venous pressure in the EBM
25 Flow Diagram.
Target value: built-up pressure ±10 mmHg

 Check the pre-filter pressure in the EBM Flow Diagram.

Target value: built-up pressure ±15 mmHg
Example with ±10 mmHg:
Built-up pressure: 283 mmHg
Target value: 273 mmHg to 293 mmHg
Example with ±15 mmHg:
Built-up pressure: 283 mmHg
Target value: 268 mmHg to 298 mmHg
 Remove the rinse connector from the rinse port.
 Close the rinse port.
 In the BLOOD SYSTEM menu, select the Remove lines field.
 Remove the cassette system.
 Remove any external test equipment.

Check  Perform the pneumatics test (see chapter 9.5.3.1 on page 241).
 Perform the Single-Needle pneumatics test (option) (see
chapter 9.5.3.2 on page 243).

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 Check that the temperature value (26)

26 displayed in the EBM Flow Diagram is
plausible.
27  Place your finger on the Single-Needle
level detector (option) (27) and check its
28
status in the EBM Flow Diagram.
 Place your finger on the venous bubble
catcher level detector (28) and check its
status in the EBM Flow Diagram.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the EBM T1 test (see chapter 10.3.2 on page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.11 Removing and installing the pneumatic unit

C36
DR8

F1
C20

SH1
2
1

C38 DR4
+
Removal:
+

IC6
1

R3
C24
X_HEP

R9 C12
X_DOOR

1
2

C212
DR123

D10
C21

C32 R29 D5
X_ASK_2
C205

R33
+ C6
R7

+C25
X_LVP

C201

 Open the EBM.

DR9 IC3
F3

C1
R11

C4
1
C179
R398

X_POWER

C183
IC49 DR1
C10
X_ART_CL
1

2
1

DR5
X_V902_DN

R49
R48
R45
R38

R4
R1
1

C206 C207
R54 C184
X_ASK

1
R396

DR3

C13 IC1
T41

DR12 C39 C34

 Open the electronics plate.

DR10
R275

DR11 R61 C14

+
X_VEN_CL

C31

IC11
1

DR13 C7
1

R22
R21
X_SN_TANK

R18

C211 C8
T3

D13 D8
1

DR6
F4
2

X_42
1

R5
X_SP_HALL

R35 1 8
F2

R10

D14
T4

 Unlock connector X_PNEUM (1) and

1

R46
R40
R34
X_PNEUM

D9
C180

R50
R6
R411

R62
R39
R36

C37 C33
X_MOD_LEAK
X_SP

C209
2

2
1

remove from PCB LP 1178.

C28

IC10
1

X_CAN_MASTER
X_BP_HALL

X_CAN_2

X_CAN_3
6

R55
DR7
2
1

R51
X_DOOR_CLOSE

C191
1
1

 Pull out the cable.

X_SN

R72

C192
T8

D11
2

R73 R75
1

T12
X_BP

X_ABD

C208 R12
R58
R63 R64

C210
R26

R14
R30
T6

R79
R13 R15
T9

T1 T2
R41

R76
T5

R59
T7

IC7
11

C35
12

R65

R77
R31
R27
T10
D15

R66
J1

R78
R28 C27
R25 C26
R24 C23
R23 C22
R19 C19
R16 C18
R57
R56
R53
R52
R47
R43
R42
R37
R95
R94
R93
R92
R91
R90
R88
R87
C181
R104
R103
R102

C182

4
R111
R110
R109
R108

R105
R106

R67 D12
+
C52

D16
+

R98 R397 T11 R68

R82
C48

R85

R101 R99 R97 R96 R74 R71 R70 C15

C50

C40

C29
C42
C46

R2

IC24 IC22 IC20 IC18 IC16 IC14 IC12 IC8 IC4 IC2
C44 R84

R89 R81 R69 R44

C51

C16 R8

C55
R80
R86

R60

R83 R17
C53

R32
IC25

D7 D6 D4
IC23 IC21 IC19 IC17 IC15 IC13 IC9
R100

R112 C54 IC5 D2 D1

C47

C17
C43

C41
IC26

C45

C30

D3
R107

C11
C9
C5

R113
C3
C2

b b b b
1 X_OS1 a 1 X_OS2 a 1 X_SS1 a 1 X_SS2 a

2
 Mark all pneumatic tubings (2) as
appropriate.
 Cut off all pneumatic tubings (2) directly at
5 the adapter fitting (see chapter 10.11.4 on
3 page 334).
 Loosen the wire tube clamp (3).

4  Pull off the blue tubing (4).

 Loosen the 2 screws (5).
 Remove the pneumatic unit.

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Installation:
 Perform the installation in reverse logical
order.
 Attach all pneumatic tubings as shown in
the pneumatics overview (see
chapter 11.6.1 on page 498).
If one pneumatic tubing is too short, replace it
according to length specifications in the
pneumatics overview.

More detailed figure (see chapter 11.6.1 on page 498)

Check  Perform the pneumatics test (see chapter 9.5.3.1 on page 241).
 Perform the Single-Needle pneumatics test (option) (see
chapter 9.5.3.2 on page 243).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.12 Removing and installing the drawbar

Removal:
 Open the EBM.
 Swing open the electronics plate.
 Remove the screw (1) of the protective
earth cable.
1
2  Remove the cable tie (2).

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Chapter 10: Servicing/repair

 Remove the 2 screws (3).

 Pull the pressure actuator (4) in the

direction of the arrow.
The pressure actuator must maintain its
position.
 Remove the swivel plate (5).
4

 Remove the 2 screws (6).

6

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 Chapter 10: Servicing/repair

 Remove the circlip (7).

 Remove the pin (8).

 Remove the lever arm (9).

 Remove the hinge (10).

10

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Chapter 10: Servicing/repair

 Pull the lever arm (11) with bolt and

washer out of the drawbar (12) of the door
lock.
 To avoid damage to the seal, twist the
11 drawbar (12) of the door lock to remove it.

12

13  Remove the locating screw (13).

 Remove the Hall sensor (14).

14

Installation:
 Perform the installation in reverse logical
order.
15  Screw the locating screw (13) into the hole
in the Hall sensor (14).
 Lightly grease the seal (15) with
POLYLUB GLY151 using a Texwipe
swab.
 To avoid crushing or extruding the seal
(15), twist the drawbar (12) of the door
lock to attach it.
 Ensure that the seal (15) is correctly
seated.

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 Chapter 10: Servicing/repair

 Tighten the 2 screws (16) with the

specified wrench torque.
16
Specified wrench torque of screws (16):
130 Ncm

 Tighten the 2 screws (17) with the

specified wrench torque.
Specified wrench torque of screws (17):
17 230 Ncm

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Chapter 10: Servicing/repair

 Tighten the screw (18) with the specified

wrench torque.
Specified wrench torque for the screw for the
protective earth conductor (18): 230 Ncm
 Fix the cable tie (19) as shown in the
18 illustration.
19

Check:
 Check status of the door detector (20) in
the EBM Flow Diagram.
20
 Perform the pneumatics test (see
chapter 9.5.3.1 on page 241).
 When moving the pressure actuator,
ensure that the pressure actuator moves
steadily and without catching.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.13 Removing and installing the door lock Hall sensor

C36
DR8

F1
C20

SH1
2
1

C38 DR4
+
Removal:
+

IC6
1

R3
C24
X_HEP

R9 C12
X_DOOR

1
2

C212
DR123

D10
C21

C32 R29 D5
X_ASK_2
C205

R33
+ C6
R7

+C25
X_LVP

C201

 Open the EBM.

DR9 IC3
F3

C1
R11

C4
1
C179
R398

X_POWER

C183
IC49 DR1
C10
X_ART_CL
1

2
1

DR5
X_V902_DN

R49
R48
R45
R38

R4
R1
1

C206 C207
R54 C184
X_ASK

1
R396

DR3

C13 IC1
T41

DR12 C39 C34

 Swing open the electronics plate.

DR10
R275

DR11 R61 C14

+
X_VEN_CL

C31

IC11
1

DR13 C7
1

R22
R21
X_SN_TANK

R18

C211 C8
T3

D13 D8
1

DR6
F4
2

X_42
1

R5
X_SP_HALL

R35 1 8
F2

R10

D14
T4

 Unplug connector X_DOOR_CLOSE (1)

1

R46
R40
R34
X_PNEUM

D9
C180

R50
R6
R411

R62
R39
R36

C37 C33
X_MOD_LEAK
X_SP

C209
2

2
1

from PCB LP 1178 and pull out the cable.

C28

IC10
1

X_CAN_MASTER
X_BP_HALL

X_CAN_2

X_CAN_3
6

R55
DR7
2
1

R51
X_DOOR_CLOSE

C191
1
1

X_SN

R72

C192
T8

D11
2

R73 R75
1

T12
X_BP

X_ABD

C208 R12
R58
R63 R64

C210
R26

R14
R30
T6

R79
R13 R15
T9

T1 T2
R41

R76
T5

R59
T7

IC7
11

C35
12

R65

R77
R31
R27
T10
D15

R66
J1

R78
R28 C27
R25 C26
R24 C23
R23 C22
R19 C19
R16 C18
R57
R56
R53
R52
R47
R43
R42
R37
R95
R94
R93
R92
R91
R90
R88
R87
C181
R104
R103
R102

C182

4
R111
R110
R109
R108

R105
R106

R67 D12
+
C52

D16
+

R98 R397 T11 R68

R82
C48

R85

R101 R99 R97 R96 R74 R71 R70 C15

C50

C40

C29
C42
C46

R2

IC24 IC22 IC20 IC18 IC16 IC14 IC12 IC8 IC4 IC2
C44 R84

R89 R81 R69 R44

C51

C16 R8

C55
R80
R86

R60

R83 R17
C53

R32
IC25

D7 D6 D4
IC23 IC21 IC19 IC17 IC15 IC13 IC9
R100

R112 C54 IC5 D2 D1

C47

C17
C43

C41
IC26

C45

C30

D3
R107

C11
C9
C5

R113
C3
C2

b b b b
1 X_OS1 a 1 X_OS2 a 1 X_SS1 a 1 X_SS2 a

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2  Remove the drawbar (see

chapter 10.11.12 on page 369).
 Remove the locating screw (2).
 Remove the Hall sensor (3).

Installation  Perform the installation in reverse logical order.

 Insert the Hall sensor (3) as shown and secure it with the locating
screw (2).
 Install the drawbar (see chapter 10.11.12 on page 369).

Check:
 Check status of the door detector (4) in the
EBM Flow Diagram.
4
 Perform the pneumatics test (see
chapter 9.5.3.1 on page 241).
 When moving the pressure actuator,
ensure that the pressure actuator moves
steadily and without catching.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.14 Removing and installing the pressure actuator

Removal:
 Open the door.
 Open the EBM.
1
 Swing open the electronics plate.
 Cut off the pneumatic tubing (1) directly at
2
the adapter fitting.
 Unscrew the screws (2) of the pressure
actuator.

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Chapter 10: Servicing/repair

 Pull the pressure actuator (3) in the

direction of the arrow and hold it.
3  Remove both swivel plates (4).

5  Remove the guide bolt (5) using the short-

shank Allen wrench.
 Remove the pressure actuator.

Installation:
 Perform the installation in reverse logical
order.
6
 Insert the guide bolt into the opening (6)
on the pressure actuator.
 Tighten the guide bolt using the short-
shank Allen wrench.

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 Chapter 10: Servicing/repair

 Tighten the 4 screws (7) with the specified

wrench torque.
Specified wrench torque of screws (7):
230 Ncm

Check  Perform the pneumatics test (see chapter 9.5.3.1 on page 241).
 When moving the pressure actuator, ensure that the pressure
actuator moves steadily and without catching.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.15 Removing and installing the pressure vessel

Removal:
 Open the right side panel (see
chapter 10.6.9 on page 291).
 Pull up the lever (1) and detach the UF
pump (2).
1  Put the UF pump (2) to one side.

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Chapter 10: Servicing/repair

3  Open the EBM.

 Remove the 2 screws (3) on the inside of
the housing and hold the pressure vessel
steady.

 If necessary, mark the pneumatic tubing

+ (4) of the negative pressure vessel (–).
 If necessary, mark the pneumatic tubing
5 (5) of the positive pressure vessel (+).

–  Cut off the pneumatic tubings (4) and (5)

directly at the adapter fitting.
 Remove the pressure vessel.
4

Installation  Perform the installation in reverse logical order.

 Push pneumatic tubing (4) onto the negative pressure vessel (–).
 Push pneumatic tubing (5) onto the positive pressure vessel (+).
If one pneumatic tubing is too short, replace it according to length
specifications in the pneumatics overview.

Check  Switch the device on and wait until the system compressor is no
longer active (see chapter 9.3 on page 224).
 Wait for a stabilization time of 5 minutes.
The system compressor may not become active while this time is
elapsing.
 Note down the positive and negative pressure values from the EBM
Flow Diagram.
 Wait until the measuring time of 2 minutes has elapsed.
 Note down the positive and negative pressure values again.
The device is pneumatically tight if the positive pressure decreases by
no more than 79 mbar and the negative pressure rises by no more than
10 mbar during the measuring time.

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 Chapter 10: Servicing/repair

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.16 Checking and repair in case of blood or fluid ingress via the pneumatic
connections

Considerations for  Read the information under "Considerations for working on the
working on the device device" (see chapter 2.5 on page 19).

Checking the EBM outside  Check the following components on the door in the vicinity of the
pneumatic connections for residual blood, fluids, and precipitation:
– Cassette coupling port
– Cassette deaeration port / Single-Needle port
– Pneumatic tubings (design hood needs removing).
 Replace contaminated components with new ones.

Checking the EBM inside  Open the EBM (see chapter 10.11.2 on page 328).
 Check the following components in the vicinity of the cassette
coupling port for residual blood, fluids, and precipitation:
– Cassette coupling port
– Hydrophobic filter F_NBC_3 between cassette coupling port and
air distributor board
– Pneumatic unit
 Replace contaminated components and the associated pneumatic
tubings.
 Check the following components in the vicinity of the cassette
deaeration port / Single-Needle port for residual blood, fluids, and
precipitation:
– Cassette deaeration port / Single-Needle port
– Single-Needle condensate separator (option)
– Single-Needle unit (option)
– Single-Needle air expansion tank (option)
– Vent valve V902 (devices without Single-Needle (option))
 Replace contaminated components and the associated pneumatic
tubings.
 If the components that have been contaminated with blood or fluid
cannot be definitely determined, then replace the following
components:
– Complete actuator-sensor unit
– Cassette coupling port
– Hydrophobic filter F_NBC_3 between cassette coupling port and
air distributor board
– Pneumatic unit
– Cassette deaeration port / Single-Needle port
– Single-Needle condensate separator (option)
– Single-Needle unit (option)
– Single-Needle air expansion tank (option)
– Vent valve V902 (devices without Single-Needle (option))
– All pneumatic tubings

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Chapter 10: Servicing/repair

Checking the housing  Check the housing main part and other components (e.g., PCB
main part LP 1202-3, PCB LP 1178, BVM, BTM, BPM, etc.) and clean or
replace them if they are contaminated.

Checking the device's  Check the internal hydrophobic filters (see following pictures) to find
internal hydrophobic out whether they are wet with fluid and replace if necessary.
filters

Fig.: EBM with Single-Needle (option)

Air distributor board

Air distributor board 1

3 Cassette coupling port

Pneumatic unit
Atmosphere

Pneumatic unit

 Ensure that the hydrophobic filter F_NBC_3 (1) is oriented

(blue/transparent) as shown in the illustration.
 Ensure that the hydrophobic filter F_NBC_1 (2) is oriented
(blue/transparent) as shown in the illustration.
 Ensure that the hydrophobic filter F_NBC_2 (3) is oriented
(blue/transparent) as shown in the illustration.

Check  Check the Installation altitude field in the SETUP  Settings

Hydraulics menu.
 Calibrate the cassette sensors (see chapter 9.4.12 on page 238).
 Perform the pneumatics test (see chapter 9.5.3.1 on page 241).
 Perform the Single-Needle pneumatics test (option) (see
chapter 9.5.3.2 on page 243).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the EBM T1 test (see chapter 10.3.2 on page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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 Chapter 10: Servicing/repair

10.11.17 Removing and installing the emergency unlocking mechanism

Removal:
 Switch off the device.
1
 Cut off the pneumatic tubing (1) directly at
2 the adapter fitting (see chapter 10.11.4 on
page 334).
3
 Open the tube clamp (3) and pull off the
white tubing.
 Remove the screw (2).
 Remove the emergency release.

Installation:
 Perform the installation in reverse logical
order.
4 Check:
 Manually pull the pressure actuator (4) to
the rear.
The pressure actuator must maintain its
position.

 Screw on a 50 ml Luer-Lock syringe filled

with air (5) and empty the syringe.
The pressure actuator must move to its start
position.
 Perform the pneumatics test (see
chapter 9.5.3.1 on page 241).
5
Additionally with Single-Needle (option):
 Perform the Single-Needle pneumatics
test (option) (see chapter 9.5.3.2 on
page 243).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the EBM T1 test (see chapter 10.3.2 on page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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Chapter 10: Servicing/repair

10.11.18 Removing and installing the catch of the occlusion clamps

Removal:
 Insert the assembly tool under the tabs at
the side of the catch.
This bends the tabs up slightly so that the
catch can be removed.
 Remove the catch.

Installation:
 Place the mounting tool next to the
occlusion clamp.
 Push the catch onto the occlusion clamp
from the side, over the mounting tool.

 Remove the mounting tool.

When removing the mounting tool, the side
tabs will click into place in the latches on the
occlusion clamp.
 Check that the catches are securely
mounted and work properly.

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 Chapter 10: Servicing/repair

Final tasks No final tasks needed.

10.11.19 Removing and installing the optical detector / air bubble detector (ABD)

Note
The ultrasonic sensor may shift in its position if a tubing is inserted into
the air bubble detector (ABD) in the dismantled state.
 Do not insert any tubing into the dismantled air bubble detector.

Removal:
1  Loosen the 2 screws (1).
 Detach the pneumatic unit.
 Loosen the 1 screw (2).

2
 Unplug the connector of the protective
earth conductor (3).

 Loosen the 1 screw (4).

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Chapter 10: Servicing/repair

 Carefully lift and remove the cover (5) with

a screwdriver as shown.

 Unplug connector (6) (venous) and

connector (7) (arterial).
8
 To remove the PCB, loosen the 2 screws
6
(Torx) (8) and take out the PCB.
7

Installation  Perform the installation in reverse logical order.

 Ensure correct seating of the seal.
 Turn the screws (8) evenly and lightly.
 Tighten the screws (8) with the specified wrench torque.
Specified wrench torque of screws (8): 60 Ncm

Check  Alternately dim the arterial and venous optical detectors and check
the sensor reaction in the EBM Flow Diagram. Ensure correct
allocation (arterial/venous).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the EBM T1 test (see chapter 10.3.2 on page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.11.20 Heparin pump

10.11.20.1 Removing and installing the heparin pump grip handle

Removal:
 Move the grip handle to its central
position.
 Remove the protective cap (1).
2
1  Apply marking (2) to between the grip
handle and the slide carriage.

 Remove the protective cap (3).

 Loosen the lock screw (4) with a 6 mm

Allen wrench.

4  Remove the sleeve nut (5) with a 12 mm

wrench.

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Chapter 10: Servicing/repair

 Loosen the threaded pin (6) approx. three

turns with a 2 mm Allen wrench.

7  Push the slide carriage (7) to the left.

 Remove the grip handle (8) in the direction
of the arrow at a slight angle.
9 8  Remove the seal (9).

Installation:
 Screw the threaded pin (10) flush into the
grip handle using a 2 mm Allen wrench.
10
The threaded pin (10) must not protrude into
the opening.

11
 Push new seal (11) over the slide
carriage, with the inscription facing the
grip handle.
12
 Align the studs (12) on the shaft parallel to
the front of the EBM.
 Angle the grip handle over the studs (12)
on the shaft and push in the direction of
the arrow.
 Push the grip handle onto the slide
carriage.
The thread of the slide carriage protrudes out
of the grip handle.

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 Chapter 10: Servicing/repair

 Push the slide carriage over the shaft so

that the studs on the shaft are in the slots
(13) in the slide carriage.

13

 Push the slide carriage and the grip

handle up to the stop (14) on the shaft.

14

15  Push the grip handle as far as the marking

(15).
 Carefully screw the threaded pin (16) two
16 to three turns into the bore of the slide
carriage using a 2 mm Allen wrench.
The threaded pin is located in the bore of the
slide carriage.

 Screw the lock screw into the sleeve nut

as shown.

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Chapter 10: Servicing/repair

 Carefully screw the sleeve nut (17) into

the grip handle and tighten with a 12 mm
wrench.
17
 Tighten the lock screw (18) with a 6 mm
Allen wrench.
18
 Insert the seal in the grip handle.
 Insert the cover caps in the grip handle.
 Move the grip handle to and fro to check it
moves smoothly.

Final tasks  Perform the EBM T1 test (see chapter 10.3.2 on page 269).

10.11.20.2 Removing and installing the heparin pump length sensor

Removal:
 Unplug all connectors (1) from PCB
2 LP 1126.
 Remove PCB LP 1126. To do so,
carefully bend open the holders (2) and
1
pry them over PCB LP 1126.

 Carefully lift the plastic closure (4) using a

small screwdriver and pull the length
sensor a little to the back.
 After having pulled off the plastic closure
4 3
(4) from the metal plate, pull the length
sensor to the left. The other plastic closure
(3) remains on the metal plate.

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 Chapter 10: Servicing/repair

7 Installation:
 Put the length sensor onto the plastic
closure (5) from the left.
6 5 The cable outlet of the length sensor is on the
left.
 Slot the plastic closure (6) with the length
sensor onto the metal plate.
 Verify that the plastic closures (5) (6) have
clicked into position.
 Click the spring (7) of the length sensor
into position.

 Install PCB LP 1126. To do so, carefully

bend open the holders (9) and pry them
over PCB LP 1126.
9
 Connect all connectors (8) on PCB
LP 1126.

8
 Lay the cable accordingly.

Check:
 Check the heparin pump length sensor
(10) in the EBM Flow Diagram.

10

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the EBM T1 test (see chapter 10.3.2 on page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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Chapter 10: Servicing/repair

10.11.20.3 Removing and installing the heparin pump

Removal:
 Unplug all connectors (1) from PCB
2 LP 1126.
 Remove PCB LP 1126. To do so,
carefully bend open the holders (2) and
1
pry them over PCB LP 1126.

 Pull off the drive’s protective earth

conductor connector.
 Unscrew the 6 screws (3) from the
bracket.
 Remove the bracket.

 Remove the syringe holder (4).

 Screw the threaded pin (5) out of the slide

carriage.

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 Chapter 10: Servicing/repair

 Place the slide carriage (6) with grip

handle at an angle as shown in the figure.

 Turn the threaded pin (7) until it is

completely recessed in the thread of the
heparin pump drive.
 Carefully detach the heparin pump drive.

 Remove the slide carriage (8) with grip

handle to the right.

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Chapter 10: Servicing/repair

Installation:

10  Insert the slide carriage with grip handle.

While doing this, ensure that the position
of the locating hole (9) in the slide carriage
exactly matches that of the positioning pin
(10) in the module front.
9

 Turn the threaded pin (12) until it is

11 completely recessed in the thread of the
heparin pump drive.
The threaded pin (12) should be positioned
flush between the first and second holes (11).
12

13
 Fit the heparin pump drive onto the slide
carriage. The hexagon socket of the
threaded pin must face the larger hole
(13). The pin of the threaded pin must face
the smaller hole (14).

14

 Screw the threaded pin (15) into the drive

15
shaft through the larger hole (16).
Specified wrench torque for threaded pin
(15): 60 Ncm
 Make sure the journal of the threaded pin
protrudes through the small hole in the
tube.

16

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 Chapter 10: Servicing/repair

 Screw the new threaded pin (17) with self-

17 locking lacquer into the upper threaded
hole (18).
Specified wrench torque for threaded pin
(17): 60 Ncm

18

 Install the bracket.

 Insert the syringe holder.
 Screw the 6 self-tapping screws (19) into
the bracket.
 Push the drive’s protective earth
conductor connector back on.
19
 Install PCB LP 1126. To do so, carefully
bend open the holders and pry them over
PCB LP 1126.
 Connect all connectors on PCB LP 1126.
 Lay the cable accordingly.

Check:
 Perform the EBM T1 test.
 Check the heparin pump for proper
function.
 Check the heparin pump length sensor
(20) in the EBM Flow Diagram.
20

Note
Always use a new threaded pin, as it is coated with self-locking lacquer.

Note
As different heparin pump types have been installed, installation details
may differ from the described installation procedure.

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Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the EBM T1 test (see chapter 10.3.2 on page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.21 Removing and installing the rinse port

Removal:
 Open the side panels.
 Open the EBM.

1  Detach the cover from the electronics

chassis in the hydraulics.
 Unplug connector X_S29_S30 (1) from
PCB LP 1140 and pull out the cable.

2
On devices without Single-Needle
(option):
 Loosen the 2 screws (2).
 Remove the vent valve V902 from the
keyhole attachment and put it aside.
3  Pull off the tubing (3) to valve V33 and
close it with a closing plug.
4
 Pull off the tubing (4) to valve V32 and
close it with a closing plug.

5
On devices with Single-Needle (option):
 Loosen the 2 screws (5).
 Remove the Single-Needle unit (option)
6 from the keyhole attachment and put it
7 aside.
 Pull off the tubing (6) to valve V33 and
close it with a closing plug.
 Pull off the tubing (7) to valve V32 and
close it with a closing plug.

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 Chapter 10: Servicing/repair

 Remove the 3 screws (8).

8
 Remove the rinse port.

Installation:
 Perform the installation in reverse logical
order.
Check:
 Check the status of the rinse port (9) in the
EBM Flow Diagram.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

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Chapter 10: Servicing/repair

10.11.22 Removing and installing the air feeding unit V42

Removal:
 Open the EBM.
 Remove the 2 screws (1).
 Unplug the 2 connectors (2) from valve
V42.
1

 Loosen the wire tube clamp (3) and pull off

the tubing from the hydrophobic filter.
 Pull of the tubing (5) to valve V32.
3
 Loosen the wire tube clamp (6) and pull off
Pneumatic unit the white tubing.
4  Remove the air feeding unit.
V42 Installation:
 Install in reverse order.
5
 Ensure that the hydrophobic filter F42 (4)
6
is oriented (blue/transparent) as shown in
the illustration.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

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10.11.23 Removing and installing the rotor

Removal:
 Push down the lock (1) to remove the
rotor.
 Pull off the rotor.
 Be very careful while handling the rotor
because, otherwise, the roller clamps will
change their position.
Installation:
1
 To install the rotor, push down the lock
and fit the rotor.
Checking with the original rotor:
No check required.

Checking with a new rotor:

 Switch off the device.
 Turn the rotor out of its starting position.
The guide roller (2) must not be within the
2 straight line shown.
 Close the door.
 Switch the device on.
The rotor is turned into its starting position.
 Check the starting position of the rotors.

Final tasks No final tasks needed.

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Chapter 10: Servicing/repair

10.11.24 Removing and installing the rotor brake

Removal:
 Remove the rotor (see chapter 10.11.23
on page 397).

2 1  Open the EBM.

 Open the electronics plate.
 Cut off the pneumatic tube of the rotor
brake (1) directly at the adapter fitting.
 Remove the 2 screws (2).
 Remove the following components:
– Cover with O-ring
– Pressure spring
– Pin and piston
– Spring
– Washer
– Rod seal

 Clean the inner surface (3).

3  Lightly grease the inner surface (3) with
POLYLUB GLY151 using a Texwipe
swab.

Installation:
4
 Mount the pin (4) on the new piston (5).
5  Ensure that the marking on the piston (5)
faces the screw.
 Lightly grease the pin (4) and piston (5)
with POLYLUB GLY151 using a Texwipe
swab.

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 Chapter 10: Servicing/repair

6  Place the following components onto the

7 pin (9) in the order shown.
8 – Spring (8)
– Washer (7)
9 – Rod seal (6)
 Ensure that the rod seal (6) is fitted as
shown.

 Install all the previously assembled

components into the housing.
 Mount the cover with O-ring (10) and
secure it using 2 screws (11).
Specified wrench torque of the 2 screws (11):
11 130 Ncm
10

 Attach the pneumatic tube of the rotor

brake (12).
 Install the rotor (see chapter 10.11.23 on
page 397).
12

Check  Perform the pneumatics test (see chapter 9.5.3.1 on page 241).
 Start the pneumatics test again to check the rotor brake.
 Remove the rotors according to the instructions provided with the
device.
Message: Clamp both tubings leading to the pressure vessel for
negative / positive pressure at the opening to the hydraulics! –
Confirm.
 Ignore the above message and do not clamp the tubings to the
pressure vessel.
This is necessary in order to check the rotor brakes.
 Select the Confirm field.

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Chapter 10: Servicing/repair

Immediately after confirming the message, the rotor brakes extend and
pressure is applied to the door.
 Looking through the door, check that the rotor brakes have fully
extended within one second.
 Wait until the door is fully pressurized.
 If the pneumatic overpressure POver in the EBM Flow Diagram is
stable, stop the pneumatics test.
Immediately after stopping the test, the rotor brakes retract.
 Ensure that this process takes no longer than 1 second.
 Looking through the door, check that the rotor brakes have fully
retracted within one second.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.25 Removing and installing the blood and substituate pump drives

C36
DR8

F1
C20

SH1
2
1

C38 DR4
+
Removal:
+

IC6
1

R3
C24
X_HEP

R9 C12
X_DOOR

1
2

C212
DR123

D10
C21

C32 R29 D5
X_ASK_2
C205

R33
+ C6
R7

+C25
X_LVP

C201

 Open the EBM.

DR9 IC3
F3

C1
R11

C4
1
C179
R398

X_POWER

C183
IC49 DR1
C10
X_ART_CL
1

2
1

DR5
X_V902_DN

R49
R48
R45
R38

R4
R1
1

C206 C207
R54 C184
X_ASK
R396

DR3

C13 IC1
T41

DR12 C39 C34

 Open the electronics plate.

DR10
R275

DR11 R61 C14

+
X_VEN_CL

C31

IC11
1

DR13 C7
1

R22
R21
X_SN_TANK

R18

C211 C8
T3

D13 D8
1

DR6
F4
2

X_42
1

R5
X_SP_HALL

R35 1 8
F2

R10

D14
T4

 Unplug connector 19/X_SP (1)

1

R46
R40
R34
X_PNEUM

D9
C180

R50
R6
R411

R62

1
R39
R36

C37 C33
X_MOD_LEAK
X_SP

C209
2

2
1

(substituate pump) or connector 18/X_BP

C28

IC10
1

X_CAN_MASTER
X_BP_HALL

X_CAN_2

X_CAN_3
6

R55
DR7
2
1

R51

(2) (blood pump) as appropriate from PCB

X_DOOR_CLOSE

C191
1
1

X_SN

R72

C192

2 LP 1178.
T8

D11
2

R73 R75
1

T12
X_BP

X_ABD

C208 R12
R58
R63 R64

C210
R26

R14
R30
T6

R79
R13 R15
T9

T1 T2
R41

R76
T5

R59
T7

IC7
11

C35
12

R65

R77
R31
R27
T10
D15

R66
J1

R78
R28 C27
R25 C26
R24 C23
R23 C22
R19 C19
R16 C18
R57
R56
R53
R52
R47
R43
R42
R37
R95
R94
R93
R92
R91
R90
R88
R87

 Pull out the cable.

C181
R104
R103
R102

C182

4
R111
R110
R109
R108

R105
R106

R67 D12
+
C52

D16
+

R98 R397 T11 R68

R82
C48

R85

R101 R99 R97 R96 R74 R71 R70 C15

C50

C40

C29
C42
C46

R2

IC24 IC22 IC20 IC18 IC16 IC14 IC12 IC8 IC4 IC2
C44 R84

R89 R81 R69 R44

C51

C16 R8

C55
R80
R86

R60

R83 R17
C53

R32
IC25

D7 D6 D4
IC23 IC21 IC19 IC17 IC15 IC13 IC9
R100

R112 C54 IC5 D2 D1

C47

C17
C43

C41
IC26

C45

C30

D3
R107

C11
C9
C5

R113
C3
C2

b b b b
1 X_OS1 a 1 X_OS2 a 1 X_SS1 a 1 X_SS2 a

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 Remove the 4 screws (3).

 Remove the screw (4) of the protective
earth cable.
 Remove the drive of the blood or
substituate pump as appropriate.
3
 Remove the seal as necessary.

Installation:
 Perform the installation in reverse logical
order.
 Lay the cable (5) of the Hall sensor in the
groove (6).
 Make sure no cables are trapped when
5
installing.
6  Mount the drive of the blood or substituate
pump with 4 screws (3).
Specified wrench torque of the 4 screws (3):
230 Ncm
 Use a new toothed washer when
reconnecting the protective earth cable.
Specified wrench torque for the screw for the
protective earth conductor (4): 230 Ncm

C36
DR8

F1
C20

SH1
2
1

C38 DR4
+
Check:
+

IC6
1

R3
C24
X_HEP

R9 C12
X_DOOR

1
2

C212
DR123

D10
C21

C32 R29 D5
X_ASK_2
C205

R33
+ C6
R7

+C25
X_LVP

C201

 Check that the substituate pump is

DR9 IC3
F3

C1
R11

C4
1
C179
R398

X_POWER

C183
IC49 DR1
C10
X_ART_CL
1

2
1

DR5
X_V902_DN

R49
R48
R45
R38

R4
R1
1

R54 C184

connected to connector 19/X_SP (7).

C206 C207
X_ASK
R396

DR3

C13 IC1
T41

DR12 C39 C34

DR10
R275

DR11 R61 C14

+
X_VEN_CL

C31

IC11
1

DR13 C7
1

R22
R21
X_SN_TANK

R18

C211 C8
T3

D13 D8
1

 Check that the blood pump is connected

DR6
F4
2

X_42
1

R5
X_SP_HALL

R35 1 8
F2

R10

D14
T4
1

R46
R40
R34
X_PNEUM

D9
C180

R50
R6
R411

R62

7 to connector 18/X_BP (8).

R39
R36

C37 C33
X_MOD_LEAK
X_SP

C209
2

2
1

1
C28

IC10
1

X_CAN_MASTER
X_BP_HALL

X_CAN_2

X_CAN_3
6

R55
DR7
2
1

R51
X_DOOR_CLOSE

C191
1
1

X_SN

R72

C192

8
T8

D11
2

R73 R75
1

T12
X_BP

X_ABD

C208 R12
R58
R63 R64

C210
R26

R14
R30
T6

R79
R13 R15
T9

T1 T2
R41

R76
T5

R59
T7

IC7
11

C35
12

R65

R77
R31
R27
T10
D15

R66
J1

R78
R28 C27
R25 C26
R24 C23
R23 C22
R19 C19
R16 C18
R57
R56
R53
R52
R47
R43
R42
R37
R95
R94
R93
R92
R91
R90
R88
R87
C181
R104
R103
R102

C182

4
R111
R110
R109
R108

R105
R106

R67 D12
+
C52

D16
+

R98 R397 T11 R68

R82
C48

R85

R101 R99 R97 R96 R74 R71 R70 C15

C50

C40

C29
C42
C46

R2

IC24 IC22 IC20 IC18 IC16 IC14 IC12 IC8 IC4 IC2
C44 R84

R89 R81 R69 R44

C51

C16 R8

C55
R80
R86

R60

R83 R17
C53

R32
IC25

D7 D6 D4
IC23 IC21 IC19 IC17 IC15 IC13 IC9
R100

R112 C54 IC5 D2 D1

C47

C17
C43

C41
IC26

C45

C30

D3
R107

C11
C9
C5

R113
C3
C2

b b b b
1 X_OS1 a 1 X_OS2 a 1 X_SS1 a 1 X_SS2 a

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Chapter 10: Servicing/repair

 Switch off the device.

 Turn the rotor out of its starting position.
The guide roller (9) must not be within the
straight line shown.
9  Close the door.
 Switch the device on.
The rotor is turned into its starting position.
 Check the starting position of the rotors.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.26 Single-Needle (option)

10.11.26.1 Removing and installing the Single-Needle air expansion tank (option)

Removal:
3  Unplug the connecting cable of connector
1
X1 (1) from PCB LP 1180.
2
 Cut off the pneumatic tubing (2) directly at
the adapter fitting (see chapter 10.11.4 on
page 334).
 Remove the 3 screws (3).
 Remove the Single-Needle air expansion
tank (option).

Installation  Perform the installation in reverse logical order.

Check  Perform the pneumatics test (see chapter 9.5.3.1 on page 241).
 Perform the Single-Needle pneumatics test (option) (see
chapter 9.5.3.2 on page 243).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).

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 Chapter 10: Servicing/repair

 Measure the device leakage current (see chapter 10.3.4 on

page 273).

10.11.26.2 Removing and installing the Single-Needle unit (option)

Removal:
 Unplug connector X_SN (1) from the
1
Single-Needle unit (option).
 Cut off the SN-TANK pneumatic tubing (2)
2 directly at the adapter fitting (see
chapter 10.11.4 on page 334).

 Cut off the BACK pneumatic tubing (3)

5 directly at the adapter fitting (see
chapter 10.11.4 on page 334). The
3 pneumatic tubing BACK is black.
 Cut off the FWD pneumatic tubing (4)
4 directly at the adapter fitting (see
chapter 10.11.4 on page 334). The
pneumatic tubing FWD is blue.
 Loosen the 2 screws (5).
 Remove the Single-Needle unit (option).

Installation  Perform the installation in reverse logical order.

Check  Perform the pneumatics test (see chapter 9.5.3.1 on page 241).
 Perform the Single-Needle pneumatics test (option) (see
chapter 9.5.3.2 on page 243).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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Chapter 10: Servicing/repair

10.11.26.3 Removing and installing the Single-Needle condensate separator (option)

Removal:
 Open the EBM.
 Cut off the BACK pneumatic tubing (1)
1 directly at the adapter fitting (see
chapter 10.11.4 on page 334). The
pneumatic tubing BACK is black.

2  Cut off the FWD pneumatic tubing (2)

directly at the adapter fitting (see
chapter 10.11.4 on page 334). The
pneumatic tubing FWD is blue.

 Remove the design hood.

 Close the door.
 Cut off the pneumatic tubing (3) directly at
3
the adapter fitting (see chapter 10.11.4 on
page 334).
 Detach the condensate separator (4) from
the door.
4
 Remove the condensate separator (4)
with double-lumen tubing from the EBM.

Installation:
 Remove the cover (5) from the door hinge.

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 Chapter 10: Servicing/repair

 Pull the double-lumen tubing (6) of the

condensate separator into the door hinge
as shown.
6

 Pull the double-lumen tubing (6) of the

condensate separator into the opening (7)
in the EBM as shown.

 Pull the double-lumen tubing into the

EBM.

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Chapter 10: Servicing/repair

 Connect the pneumatic tubing (8) to the

cassette deaeration port.
8
 Attach the new condensate separator (9)
to the door.
9  Lay the double-lumen tubing (10) as
10 shown.

 Connect the BACK pneumatic tubing (11).

The pneumatic tubing BACK is black.
 Lay and connect the FWD pneumatic
tubing (12) as shown. The pneumatic
11 tubing FWD is blue.
 Fit the cover on the door hinge.

12  Mount the design hood.

 Replace protective caps.

Check  Perform the pneumatics test (see chapter 9.5.3.1 on page 241).
 Perform the Single-Needle pneumatics test (option) (see
chapter 9.5.3.2 on page 243).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.11.27 Removing and installing the blood temperature monitor (BTM) (option)

1 Removal:
2
 Open the EBM (see chapter 10.11.2 on
page 328).
 Unplug the connector of the protective
4 earth conductor (1).
3
 Take the white and blue tubings and the
protective earth conductor out of the
holder (2).
 Unplug connector V31 (3).
 Loosen the screws (4).
 Detach valve block V31/V32/V33/V43.

5  If the BVM (option) is fitted, also do the

following:
1. Detach the cable from the holder (5).

6 2. Remove the screw (6).

3. Open the BVM (option) a little way.
4. Unplug the CAN bus connector (7).
7
5. Unplug the ribbon cable connector (8).
8 6. Open out the BVM (option) completely.

 Remove the 2 screws (9) of the protective

9 earth conductors.
10
 Unplug the CAN bus connector (10).
11  Loosen the 4 screws (11) on the BTM.
 Remove the BTM (option).

Installation  Perform the installation in reverse logical order.

 Lubricate the seal with UNISILKON L 250 L grease.
 Use new toothed washers.
 If necessary, update the software version of the module (see
chapter 9.9.1 on page 251).

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Chapter 10: Servicing/repair

 Select the Status field and check the availability of the module.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the EBM T1 test (see chapter 10.3.2 on page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.11.28 Removing and installing the blood volume monitor (BVM) (option)

1 Removal:
2
 Open the EBM (see chapter 10.11.2 on
page 328).
 Unplug the connector of the protective
4 earth conductor (1).
3
 Take the white and blue tubings and the
protective earth conductor out of the
holder (2).
 Unplug connector V31 (3).
 Loosen the screws (4).
 Detach valve block V31/V32/V33/V43.

5  Detach the cable from the holder (5).

 Remove the screw (6).
 Open the BVM (option) a little way.
6  Unplug the CAN bus connector (7).
 Unplug the ribbon cable connector (8).

7  Open out the BVM (option) completely.

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 If necessary, loosen the two screws (9)

and detach the Single-Needle unit
(option).

 Remove the screw (10) of the protective

10
earth conductor.
11  Loosen the screws (11) on the BVM.

 Loosen the screw (12) on the BVM.

12

 Open the BVM flap (12).

 Withdraw the BVM as far as the BVM flap.

12

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 Position the BVM as shown in the

illustration.

 Position the BVM as shown in the

illustration.
 Remove the BVM from the EBM.

Installation  Perform the installation in reverse logical order.

 Lubricate the seal with UNISILKON L 250 L grease.
 Use new toothed washers.
 If necessary, update the software version of the module (see
chapter 9.9.1 on page 251).
 Select the Status field and check the availability of the module.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the EBM T1 test (see chapter 10.3.2 on page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.12 Hydraulics

10.12.1 Removing and installing the pressure reducing valve A04, water inlet

Removal:
 Remove the dialysis water inlet tube from
the supply.
2  Open the tube clips and pull off the
tubings.
1
 Loosen the sleeve nut (1) of the pressure
reducing valve.
 Remove the pressure reducing valve (2).

Installation  Disinfect the inlet tubing, outlet tubing and pressure reducing valve
with an approved alcohol-based surface disinfectant (e.g.,
Freka-NOL).
 Perform the installation in reverse logical order.
 Ensure that the tubings are tight.
 Set the maximum water inflow (see chapter 9.2.1 on page 222).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

10.12.2 Removing and installing the water inlet block

Removal:
 Open the left side panel (see
1
chapter 10.6.9 on page 291).
 Remove the dialysis water inlet tube from
2 the supply.
 Protect components from leaking fluid.
 Release the water inlet block (1) from the
SNAPLOC attachment.
 Detach the tubing from the holder (2).

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 Pull off the tubing (3) (valve V03 to the

3 T-piece) and mark the opening with a
closing plug.
4  Pull of the tubing (4) (valve V38 to the
water inlet chamber) and mark the
5 opening with a closing plug.
8
 Pull off the tubing (5) (valve V03 to the
6 heat exchanger) and mark the opening
with a closing plug.

7  Pull off the tubing (6) (valve V19 to the

drain) and mark the opening with a closing
plug.

 Loosen the wire tube clamp of the textile-fabric tubing (7).

 Pull off the textile-fabric tubing (7) (valve V02 to the pressure
reducing valve A04) and mark the opening with a closing plug.
 Loosen the wire tube clamp of the textile-fabric tubing (8).
 Pull off the textile-fabric tubing (8) (check valve A05 to the heat
exchanger) and mark the opening with a closing plug.

 Pull off the tubing (9) (valve V19 to valve

V28) and mark the opening with a closing
9 plug.
 Unplug the connectors of the following
valves:
10 – Valve V03 (10)
11 – Valve V38 (11)
– Valve V19 (12)
12 – Valve V02 (13)
13  Remove the water inlet block.

Installation:
 Disinfect the following tubings and
connectors using an approved alcohol-
14 based surface disinfectant (e.g.,
Freka-NOL).
– Tubing (14) to the water inlet chamber
and the valve V38 connector.
15
– Tubing (15) to the heat exchanger and
the check valve A05 connector.
– Tubing (16) to the pressure reducing
16 valve A04 and the valve V02
connector.
 Perform the installation in reverse logical
order.

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Check  Ensure that the tubings are tight.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

10.12.3 Removing and installing the heat exchanger

Note
The heat exchanger operates using the counter-current principle.
If the tubings were swapped, the efficiency would be considerably
reduced.
 Ensure that the tubings were properly connected following the
repair.

Removal:
1  Open both side panels (see
chapter 10.6.9 on page 291).
 Remove the power supply unit (see
chapter 10.10.2 on page 318).
 Detach the tubing (1) from the right-hand
inlet of the water inlet block and close it
with a closing plug.

 Release the disinfection valve block (3)

from the SNAPLOC attachment.
 Detach the tubing (2) from the water inlet
2
chamber and close it with a closing plug.

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 Open the electronics chassis.

 Detach both tubings (4) to the right-hand
side of the hydraulic assembly and drain
the fluid into a collection reservoir.
 Remove the bicarbonate pump.

 Detach the tubing (5) (dialysate block),

drain the fluid into a collection reservoir
and mark and close off the opening with a
closing plug.
5
 Detach the tubing (6) (water inlet block),
6
drain the fluid into a collection reservoir
and mark and close off the opening with a
closing plug.
 Remove the heat exchanger from the
SNAPLOC attachment.

Installation:
7  Disinfect the tubing (7) to the heat
exchanger and the check valve A05
connector using an approved alcohol-
based surface disinfectant (e.g.,
Freka-NOL).

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 Disinfect the tubing (8) from the heat

exchanger and valve VF1 connector using
an approved alcohol-based surface
8 disinfectant (e.g., Freka-NOL).
 Perform the installation in reverse logical
order.
 Ensure that the tubings were properly
connected following the repair.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

10.12.4 Removing and installing the float switch S01 of the water inlet chamber

Removal:
 Disconnect connector S01 from PCB
LP 1140.
 Detach the tubing (1) from the bottom of
1 the water inlet chamber.
 Detach the tubing from the adapter of the
degassing orifice.
 Open the tube clamp and drain about
150 ml of fluid into a collection reservoir.

 Pull off the tubings (2).

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 Detach the water inlet chamber from the

SNAPLOC attachment.
 Remove the fixing clip (3) for the solenoid
valve.
 Lift out the solenoid valve.
 Remove the water inlet chamber.
3

 Pull off the tubings (4).

 Remove the 5 self-tapping screws from
the bottom of the chamber (see
4 chapter 10.3.7 on page 278).
 Remove the bottom of the chamber with
the float switch from the housing.

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 Remove 2 fixing clips (5) of the float

switch.
 Remove the float switch (6).
Installation:
 Perform the installation in reverse logical
5 order.
 Check for proper seating of the fixing
clamps.
 Connect connector S01 to PCB LP 1140.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

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10.12.5 Removing and installing the degassing orifice

Removal:
 Clamp the tubing (2) with a tube clamp
between the water inlet chamber and the
degassing chamber.
1  Remove the 2 screws (1) from the orifice
adapter fitting (6).

2  Remove the orifice adapter fitting (6).

Ensure that the degassing orifice and the
O-rings do not fall out.

 Check the degassing orifice (5). This

degassing orifice must not be used if
damaged.
Installation:
3
 Perform the installation in reverse logical
order.
6  Insert the O-rings (4) and the degassing
orifice (5) between the degassing
chamber (3) and the orifice adapter fitting
(6) as shown in the illustration.
 Check and calibrate the set installation
altitude in the SETUP.
 Calibrate degassing (see chapter 9.4.3 on
page 229).
5 4  Enter the pressure values in the Medical
Device Register.

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The table indicates which degassing orifice to use at which operating

altitude:

Degassing Marking Operating

orifice altitude above
MSL

1.7 mm Matt surface White dot Up to 1200 m

1.85 mm No marking Above 1200 m

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

10.12.6 Removing and installing the heater rod

Removal:
 Unplug the power plug.
 Open both side panels (see
chapter 10.6.9 on page 291).
 Loosen the 2 screws on the fixing bracket
(1).
 Unplug the connector (2) of the heater rod.
1

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 Unplug the connector of the protective

earth conductor (3).
2  Detach the heater rod chamber (2) from
the SNAPLOC holder.
 Protect components from leaking fluid.
 Remove the self-cutting screws (4) of the
3 heater rod and catch any fluid that runs
4 out.
 Remove the heater rod (4).

Installation:
L1 red  Check the nominal voltage of the new
heater rod.
L3 white
Target value: nominal voltage of heater rod =
L2 black nominal line voltage
 Check the nominal resistance values of
PE green/yellow
the heater rod against the following table.
 Perform the installation in reverse logical
order.
 Plug the connector of the protective earth
cable (3) of the external measuring point
into the heater rod.

Nominal voltage of heater rod Nominal resistance L1 – L3 Nominal resistance L2 – L3

240 V 58 Ω 58 Ω

220 V to 230 V 52 Ω 52 Ω

120 V 24 Ω 24 Ω

110 V 20 Ω 20 Ω

Calibration  Select the SERVICE  CALIBRATE menu.

 Select the Temperature (PT7/PT8/PT9) field.
 Calibrate the temperature (see chapter 9.4.5 on page 232).

Check  Select the SERVICE  SETUP  Settings Hydraulics menu.

 Next to Heater rod, select the Line voltage field and check the
value.

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Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

10.12.7 Removing and installing the concentrate pump

Removal:
 Unplug the concentrate pump connector
from PCB LP 1141-3 slot X_SOD.
 Pull off the tubings (1).
1
 Pull up the lever (2) and remove the
concentrate pump.
2

Installation:
 Perform the installation in reverse logical
order.
 Check that the concentrate pump has
3
properly clicked in to place.
 Program the concentrate pump (see
chapter 9.4.10 on page 236).
The concentrate pump connector must be
fitted to slot X_SOD (3) after programming.
 Check the conductivity for plausibility.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

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10.12.8 Removing and installing the bicarbonate pump

Removal:
1
 Unplug the bicarbonate pump connector
from PCB LP 1141-3 slot X_BIC.
 Pull off the tubings (1).
 Pull up the lever (2) and remove the
bicarbonate pump.
2

Installation:
 Perform the installation in reverse logical
order.
 Check that the bicarbonate pump has
3
properly clicked in to place.
 Program the bicarbonate pump (see
chapter 9.4.10 on page 236).
The bicarbonate pump connector must be
fitted to slot X_BIC (3) after programming.
 Check the conductivity for plausibility.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

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10.12.9 Removing and installing the UF pump

Removal:
5 1  Unplug the UF pump connector from
PCB LP 1141-3 slot X_UF.
4 2
 Pull off tubings (1) and (5).
 Unplug connectors S11/plate (4) and
3 S36/plate (2).
 Pull up the lever (3) and remove the UF
pump.

Installation:
 Perform the installation in reverse logical
order.
 Check that the UF pump has properly
6
clicked in to place.
 Check the connections of the UF pump:
– (1) S36/adapter
– (2) S36/plate
– (4) S11/plate
– (5) S11/adapter
 Program the UF pump (see
chapter 9.4.10 on page 236).
The UF pump connector must be fitted to slot
X_UF (6) after programming.

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 Read off the value (7) of the UF pump (in

the example: 1,205 ml).
 Enter the value (7) in the Service menu
under CALIBRATE  Volumes (see
chapter 9.4.7 on page 234).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

10.12.10 Removing and installing the gear pump drive

Removal:
1
 Unplug the gear pump drive connector.
 Remove the screws (2) of the gear pump.
 Pull the gear pump out of the gear pump
drive.
2
 Remove the nut (1).
 Remove the gear pump drive from the
SNAPLOC attachment (3).

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Installation  Perform the installation in reverse logical order.

 Calibrating replaced component:
– P01: (see Degassing (A02/P01) menu option on page 229)
– P03: (see Flow pump (P03/A03) menu option on page 231)

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

10.12.11 Removing and installing the gear pump

Removal:
1
 Remove the tubing (1) and close it off with
a closing plug.
 Remove the screws (2).
 Remove gear pump.
2

Installation  Perform the installation in reverse logical order.

 Calibrating replaced component:
– P01: (see Degassing (A02/P01) menu option on page 229)
– P03: (see Flow pump (P03/A03) menu option on page 231)

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

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10.12.12 Removing and installing the balancing chamber

1 Removal:
 Remove connector VG1_OS2 and
connector VG2_OS2 or pull off the
connectors directly from the valves.
 Pull off the tubings of the balancing
chamber and close them off with closing
plugs.
 Remove the locking nut (1) of the
balancing chamber.
 Remove the balancing chamber from the
SNAPLOC attachment.

Installation:

2  Insert the balancing chamber into the

SNAPLOC attachment.
 Screw in the locking nut of the balancing
chamber.
 Attach the tubings of the balancing
chamber.
 Connect connector VG1-OS2 and
connector VG2-OS2 or the individual
valves.
 Read the volume off the identification label
(in the example: 30.35 ml).
 Enter the volume value (2) in the Service
menu under CALIBRATE  Volumes
(see chapter 9.4.7 on page 234).

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 Check the connections and positions of

the valves.
 Check the conductivity for plausibility.
V12

V14

V11

V13

V15

V16 V17

V18

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

10.12.13 Removing and installing the blood leak detector

Removal:
1  Slide the cap (1) on the tubing upward.

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 Press in the locking tabs (2) and open the

blood leak detector.
 Avoid fingerprints and other
contamination on the glass cuvette.
Fingerprints or other contaminations will
falsify the measurement result.

 Remove the glass cuvette (3).

3 The glass cuvette remains connected to the
tubes.
 Remove the screws (4).
 Remove the blood leak detector.

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Installation:
 Perform the installation in reverse logical
order.
 Check the glass cuvette for fingerprints
and other contamination.
5
Fingerprints or other contaminations will
falsify the measurement result.
 If the current blood leak detector with
rounded door (5) is installed: Position the
glass cuvette centrally.
 If the old blood leak detector with angular
door (6) is installed: Position the glass
cuvette with the cone (7) on the surface
(8).
 Close the blood leak detector.
6
 Slide the protective cap onto the blood
leak detector.
 Calibrate the blood leak detector (see
chapter 9.4.8 on page 234).
7

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Select the SERVICE  DIAGNOSTICS  Hydraulics  Test menu.
 Select the Blood leak field (see chapter 9.5.6 on page 246).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program when the cuvette has been removed.

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10.12.14 Removing and installing the flap lid

Removal:
 Remove the 3 caps (1).
 Remove the 3 screws (1).
1
 Remove the cover.

Installation:
 Perform the installation in reverse logical
order.
2
 Ensure that the spring (2) of the connector
faces downward.

Final tasks  Run a disinfection program.

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10.12.15 Removing and installing the bibag connector

Removal:
 Remove the Phillips screw (1).

 Open the closure (2) inside the device.

 Pull off 2 tubings and close them off with
closing plugs.
 Unplug the microswitch connectors S21,
S22 and S47 from PCB LP 1140.

 Remove holding spring (3) and store it

(the holding spring to be used depends on
the housing).
3  Remove the bibag connector.

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Installation  Perform the installation in reverse logical order.

 Fit the holding spring (3) that was previously removed.
 In devices with EC < 055, apply Loctite 243 threadlocker to the
thread of the Phillips screw (1).
 Screw in the Phillips screw (1).
Specified wrench torque of the Phillips screw (1) with EC < 055: 50 Ncm
Specified wrench torque of the Phillips screw (1) with EC ≥ 055:
130 Ncm
 Check that the flap lid engages when closing.
 Check the bibag connector in the flow diagram (see chapter 10.14.8
on page 458).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Start the T1 test with a bibag and check whether the bibag is filled
from above (see chapter 10.3.1 on page 268).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

10.12.16 Removing and installing the concentrate rinse chamber

Removal:
 Open the left side panel (see
chapter 10.6.9 on page 291).
1  Remove the concentrate suction tube
from the rinse chamber.
 Remove the tubing (1) from the lower port
of the rinse chamber and close it off with a
closing plug.

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 Pry the rinse chamber out of the holder (3)

using a screwdriver.

Warning
Risk of crush injury due to the movable EBM door hinge
 Never reach through the EBM door hinge.
 If work must be carried out behind the EBM door hinge, first open the
EBM.

 Open the EBM.

 Remove the tubing (4) from the upper port
of the rinse chamber and close it off with a
closing plug.

 Unplug the level sensor connector (6).

 Unplug the connector of valve VS2 (5).
 Remove the rinse chamber.
5

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Installation:
 Lubricate the seat (7) of the seal with
UNISILKON L 250 L grease.
 Fit the seal on the rinse chamber.
 Perform the installation in reverse logical
order.

 Insert the seal cap (8) as necessary.

 Check the concentrate suction tube Hall
sensor in the flow diagram.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

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10.12.17 Removing and installing the bicarbonate rinse chamber

Removal:
 Open the right side panel (see
chapter 10.6.9 on page 291).
1
 Remove the bicarbonate suction tube
from the rinse chamber.
2  Open the electronics chassis.
 Unplug connector of CD cell CD5 (1) on
PCB LP 1140.
 Unplug connector of temperature sensor
PT5 (2) on PCB LP 1140.
 Unplug the connector VB2.
 Unplug the level sensor connector.

 Remove the following tubings and close

3
them with closing plugs:
– Tubing VB2 (3)
4 – Tubing S16 (4)
– Bicarbonate pump tubing (5)
– Tubing S50 (6)
5 – Tubing, lower rinse chamber connector
(7)
6
 Pry the rinse chamber out of the holder (8)
using a screwdriver.
7
 Remove the rinse chamber.
8

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Installation:
 Lubricate the seat (9) of the seal with
UNISILKON L 250 L grease.
9  Fit the seal on the rinse chamber.
 Perform the installation in reverse logical
order.

 Insert the seal cap (10) as necessary.

 Check the bicarbonate suction tube Hall
sensor in the flow diagram.

10

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

10.12.18 Removing and installing the CDS block

To disable a CDS block use the appropriate modification kit.

Two CDS blocks can be installed in the device. The second CDS block
is located at the water inlet pressure reducing valve A04. The removal
and installation of the second CDS block is comparable to that of the
first CDS block.

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1 Removal:
 Open the media supply rail (see
chapter 10.6.8 on page 290).
 Remove the CDS tubings.
 Remove the CDS connector (1).
 Remove the locking pin (2).

 Pull off the tubings (3) from the CDS block

and fit with closing plugs.

4  Push the CDS block out of the media

supply rail (do not damage the seal).
 Remove the connector (4) from the CDS
block.
 Remove the CDS block.

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5 Installation:
 Perform the installation in reverse logical
order.
 Lubricate the seals with UNISILKON L
250 L grease.
 Ensure correct seating of the seals.
 Make sure the color coding (5) is correct.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

10.12.18.1 Vent valve of CDS block

There are two variants of the CDS block vent valve. An adapter or
compensation vessel must be used depending on which vent valve is
fitted. Mixing the components is not permitted.

The newer vent valve (1) must only be

combined with the adapter (2).

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 Chapter 10: Servicing/repair

The older vent valve (3) must only be

combined with the compensation vessel (4).
3

10.12.19 Removing and installing the pressure transducer

Pressure transducer Measuring range

S03, S07, S16 –0.9 bar to 2.0 bar

S15 –0.9 bar to 3.5 bar

Removal:
 Switch off the device.
4
 Unplug the connector of the pressure
3 transducer.
1  Remove the self-cutting screws (1).
2
 Remove the holder (2).
 Remove the pressure transducer (3) and
the O-ring underneath it.

Installation  Perform the installation in reverse logical order.

 Fit the new O-ring.
 If the pressure transducer has an evacuation opening (4) and a gray
cable: Position the recess of the holder (2) over the evacuation
opening.
 Mount the pressure transducer and holder with self-cutting screws
(1).
Wrench torque: 90 Ncm.

Calibration  Calibrate the pressure transducers (S03/S07/S15/S16) (see

chapter 9.4.2 on page 229).

Check No check required.

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Chapter 10: Servicing/repair

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

10.12.20 Removing and installing the temperature sensor

Removal:
 Switch off the device.
 Unplug the connector of the temperature
1
sensor.
 Remove the screws (1).
 Remove the temperature sensor (2).

Installation  Perform the installation in reverse logical order.

Calibration
Temperature Calibration
sensor

PT2 No calibration required.

PT4

PT5

PT7 1. Calibrate the temperature (see chapter 9.4.5

on page 232).
PT8
2. Calibrate the conductivity (see chapter 9.4.6
PT9 on page 233).
3. Calibrate the OCM (see chapter 9.4.9 on
page 235).

Check No check required.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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 Chapter 10: Servicing/repair

 Run a disinfection program.

10.12.21 Removing and installing the conductivity sensor

Removal:
 Switch off the device.
1  Unplug the connector of the conductivity
sensor.
2
 Pull off the tubing (4).
 Remove the temperature sensor (3) (see
chapter 10.12.20 on page 440).
3
 Remove the screws (1).
4  Remove the conductivity sensor (2).

Installation  Perform the installation in reverse logical order.

Calibration
Conductivity Calibration
sensor

CD4 No calibration required.

CD5

CD7 1. Calibrate the temperature (see chapter 9.4.5

on page 232).
CD9
2. Calibrate the conductivity (see chapter 9.4.6
on page 233).
3. Calibrate the OCM (see chapter 9.4.9 on
page 235).

Check No check required.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

10.12.22 Removing and installing the disinfectant valve V20

Requirement Use disinfectant valve suitable for disinfectant. The disinfectant valve
has a yellow identification label.

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Chapter 10: Servicing/repair

Removal  Read the information under "Considerations for working on the

device" (see chapter 2.5 on page 19).
 Observe all safety measures applicable to the handling of
disinfectants.

 Detach disinfectant from disinfectant

connector H20 (6). The disinfectant
6
connector H20 is marked in yellow.
 Connect dialysis water to disinfectant
1
connector H20 (6).
 In the SERVICE  DIAGNOSTICS 
Hydraulics  Test menu, run the Suction
V20 function (see chapter 9.5.6 on
page 246).
 Detach dialysis water from disinfectant
5 2
connector H20 (6).

4 3
 Pull the tubing (5) off disinfectant valve
V20 (4). The tube is black and is marked
yellow.
 Remove the old disinfectant valve V20 (4).

Installation  Install the new disinfectant valve V20 (4).

 Attach the tubing (5) to disinfectant valve V20 (4). The tube is black
and is marked yellow.
 If necessary: Replace tubing with a new 300 mm long black tube
with yellow marking.

Check  Check the following points for disinfectant valve V20 (4):
– Disinfectant valve V20 is positioned on the left
– Disinfectant valve V20 is marked with V20
– Disinfectant valve V20 has a yellow identification label
– Plug for disinfectant valve V20is connected
– The tube (5) is black and is marked yellow
– The tube (5) is connected to disinfectant connector H20 (6)
 Check the following points for disinfectant valve V34 (3):
– Disinfectant valve V34 is positioned on the right
– Disinfectant valve V34 is marked with V34
– Disinfectant valve V34 has a yellow identification label
– Plug for disinfectant valve V34 is connected
– The tube (2) is black and is not marked
– The tube (2) is connected to disinfectant connector H35 (1)

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Warning
Risk of cross-contamination as a result of insufficient disinfection
Risk of contamination as a result of insufficient disinfection
If a disinfectant valve is defective, fluid from the device could enter the
disinfectant. This will dilute the disinfectant and reduce its disinfecting
effect.
 After replacing the disinfectant valve, the disinfectant in place must
be properly disposed of in accordance with the applicable national
regulations.
 After completing the work on the device, connect new disinfectant.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

10.12.23 Removing and installing the disinfectant valve V34

Requirement Use disinfectant valve suitable for disinfectant. The disinfectant valve
has a yellow identification label.

Removal  Read the information under "Considerations for working on the

device" (see chapter 2.5 on page 19).
 Observe all safety measures applicable to the handling of
disinfectants.

 Detach disinfectant from disinfectant

connector H35 (1). The disinfectant
6
connector H35 is marked in black.
 Connect dialysis water to disinfectant
1
connector H35 (1).
 In the SERVICE  DIAGNOSTICS 
Hydraulics  Test menu, run the Suction
V34 function (see chapter 9.5.6 on
page 246).
 Detach dialysis water from disinfectant
5 2
connector H35 (1).

4 3
 Pull the tubing (2) off disinfectant valve
V34 (3). The tube is black and is not
marked.
 Remove the old disinfectant valve V34 (3).

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Chapter 10: Servicing/repair

Installation  Install the new disinfectant valve V34 (3).

 Connect the tubing (2) to disinfectant valve V34 (3).
 If necessary: Replace tubing with a new 300 mm long black tube.

Check  Check the following points for disinfectant valve V20 (4):
– Disinfectant valve V20 is positioned on the left
– Disinfectant valve V20 is marked with V20
– Disinfectant valve V20 has a yellow identification label
– Plug for disinfectant valve V20is connected
– The tube (5) is black and is marked yellow
– The tube (5) is connected to disinfectant connector H20 (6)
 Check the following points for disinfectant valve V34 (3):
– Disinfectant valve V34 is positioned on the right
– Disinfectant valve V34 is marked with V34
– Disinfectant valve V34 has a yellow identification label
– Plug for disinfectant valve V34 is connected
– The tube (2) is black and is not marked
– The tube (2) is connected to disinfectant connector H35 (1)

Warning
Risk of cross-contamination as a result of insufficient disinfection
Risk of contamination as a result of insufficient disinfection
If a disinfectant valve is defective, fluid from the device could enter the
disinfectant. This will dilute the disinfectant and reduce its disinfecting
effect.
 After replacing the disinfectant valve, the disinfectant in place must
be properly disposed of in accordance with the applicable national
regulations.
 After completing the work on the device, connect new disinfectant.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

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10.12.24 Deactivating the Flush function

1
Removal:
 Observe the modification kit for
deactivating the Flush function.
 Open the media supply rail (see
2 chapter 10.6.8 on page 290).
 Pull off the tubing (1) from the solenoid
valve VF2 (2).

 Unplug the connector (3) from the

solenoid valve VF2.
 Fit an insulating plug on the connector (3).

 Open the left side panel (see

chapter 10.6.9 on page 291).
 Remove the T-piece (4), tubing (5) from
4
solenoid valve VF1 and tubing (6) from
solenoid valve VF2.

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Chapter 10: Servicing/repair

Installation:
 Disinfect tubing (7) and solenoid valve
VF1 with an approved alcohol-based
surface disinfectant (e.g., Freka-NOL).
7  Attach the tubing (7) from heat exchanger
H04 to solenoid valve VF1 and secure
with a tube clamp.
 Close the left side panel (see
chapter 10.6.9 on page 291).
 Close the media supply rail.
 Close off the adapter of the Flush drain
H02 with a plug.
 Deactivate the Flush function in the
Service setup (see chapter 5.2.1 on
page 95).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).
 Run a disinfection program.

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10.13 Checking the network interface

The network interface can be checked through a direct connection

between the computer and the device by sending a ping.

Preparations on the device  Select the SERVICE  SETUP  Network menu.

 Note down the settings.
 Set the Direct PC connect. field to Active.
 Switch the device off and back on again.

Preparations on the  Select the Control Panel menu.

computer
 Select the Network and Sharing Center menu.
 Select the Change adapter settings menu.
 Select the LAN Connection menu.
 Select the Properties field.
 Highlight Internet Protocol Version 4 (TCP/IPv4) and select the
Properties field.
 Select the Use the following IP address: field.
 Set 192.168.0.4 in the IP address: field.
 Set 255.255.255.0 in the Subnet mask: field.
 Remove value in the Default gateway: field.
 Select the Use the following DNS server address: field.
 Remove the value in the Preferred DNS server: field.
 Remove the value in the Alternate DNS server: field.
 Remove the check mark in the Validate settings upon exit field.
 Select the OK field to close the Properties of Internet Protocol
Version 4 (TCP/IPv4) menu.
 Select the OK field to close the Properties of the LAN connection
menu.

Network interface,  Connect the computer and the device using a cross cable (not a
checking regular network cable).
 Select Run on the computer and start the cmd.exe application.
The Command Prompt window is opened.
 In the Command Prompt window, enter the command: ping
192.168.0.5 and confirm with the ↵ key (Enter).

Successful check of the The following message is issued with different information if the network
network interface connection functions: Response from 192.168.0.5. This ensures that
the network interface functions.
 Select the SERVICE  SETUP  Network menu.
 Restore the original network settings on the device.
 Switch the device off and back on again.

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Chapter 10: Servicing/repair

Failed check of the The following message is issued if the network connection does not
network interface function: Destination Host Unreachable.
 Resolve the error and repeat the check.

Final tasks No final tasks needed.

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10.14 Printed circuit boards

10.14.1 PCB LP 1104 Monitor power supply board

Fig.: PCB LP 1104 – layout C

1
X1
A
18 32 1

↑ Top ↑
1 X2 8
C
C30 C31
C32 C33 C36 C35

C38

C40
C41
C37
1

DR7
DR5 2
J1

DR6
3
R26
17 3

D11
D10
F4

C29
16

C28
R23

R24

R25
DR2

DR3

DR4
IC1 IC2 IC3

XACCU
4
C26
C25

15

C27

C21
DR1
5
F5

F6

F7
C18 R22 C19 C20
R15

R18
D7
D8

D9
C14 R21 C15 R16 C16 R19
14 C12 BR1
6
R8

R11 BR2 C17

C9 C11 BR5 C13 R10 BR3
C8 C10

1
BR4
13 + C1 + C3 C4 + C5 7
8
C2

C6
40

12 D1 R1 D2 R2 D3 R3 D4 D6 R7 9
D5
R4
R5
R6

10
F2
F1

F3 11

96

Legend

Connectors (X) Solder bridges (BR)

1 X1  PC board⏐X22. 5 BR1–BR3: Screen supply voltage (see
4 XACCU  PCB LP 1106⏐X2. chapter 10.9.4.2 on page 305).
18 X2  PCB LP 1145⏐X7. 15 BR4–BR5: Backlight supply voltage (see
chapter 10.9.4.2 on page 305).
LEDs (D)
3 D11: 24 V supply voltage. Jumpers (J)
6 D4: Input switching regulator for backlight supply 2 J1: Suppression of backlight when switching on
voltage. the device.
7 D5: Output switching regulator for screen supply 2–3 closed: with boot messages (service)
voltage. 1–2 closed: without boot messages (treatment)
8 D6: Input switching regulator for screen supply
Fuses (F)
voltage.
9 F1: 2.0 AT, 5 V CPU supply voltage.
12 D1: Output switching regulator for CPU supply
10 F2: 2.0 AT, backlight supply voltage.
voltage.
11 F3: 2.0 AT, screen supply voltage.
13 D2: Input switching regulator for CPU supply
17 F4: 2.0 AT, 24 V supply voltage of the
voltage.
rechargeable battery for the monitor in case of a
14 D3: Output switching regulator for backlight
power failure.
supply voltage.
Other
16 Rubber pad on the solder side.

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Note
Monitor can be destroyed by wrong voltage
 Check the solder bridges of PCB LP 1104 against the compatibility
matrix (see chapter 10.9.4.2 on page 305).
 Only do this with the device switched off (without the solder bridges,
voltage supply is 24 V).

Installation location Monitor (see chapter 10.2.1 on page 256)

Calibration No calibration required.

Check  Verify the correct position of the connectors.

 Check the jumpers and solder bridges.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.14.2 PCB LP 1105-1 Power supply CPU (serial number section VMA)

Fig.: PCB LP 1105-1 – layout H

R32
R51
R50
R30
R29
X_POWER

C43
R75 D10

R55
R21
↑ Top ↑

C20
1

C28
T18
R83
R53

R54
1

T12
+
R1

IC10

C40
C21
IC20
T9 IC11 D12

R52
1

C47
IC7 D11 X4
2
C2
C4
C3
C5
R4

R34
R68
R33

R31

T1
R84

R12
T5
T16 D13 D16

R56
R109

T2
T11

R103
7

R94
R88
R122
D17

R58
R23
MP1 R67 R69 R70 R71

C50
R76
R81

R43
R80
R35

C39

IC23
C6

R119 D4
R73
R79

R74

R72
R101

6
D9

R108

R107

D7
R90

D5
C9
C35 R26

IC18
C34

+
R20

C22

T3
C25

IC37
IC25

IC22 IC21 C14 R24

80

61
4 1 30

R15
IC8

60
33 23

R14
5 29
R25 R18 R16 R93
R41

IC19
R42

C10 34 22
IC36

R17 R11
IC15

IC13
C37

R10
R38
R36
R44
C17

R47

IC14

T4
IC1
C8 C7 R27 R106
R104 R19 D8

IC17
44 12
IC16

C23
13 21
1 11
R13
C52

R86

14 20 R6 R89

20

41
R39

IC3

21

40
R3
MP2 C24
C13

IC28
R65
R57
R63
R64
R61

R60
R59
R62

R2

R48
C29
C51

C11
C38

C15
5 Q1
D15

+C32
2
R92 T10 T7 T8 BA1

R85
R40
R82
R37

R66 BH1

RL1
R95 R97 IC27

D6
D14
C30

C27
R100
IC30

DR7
R99

R49

C12

4
DR2

R87
DR1

R96 R98 R91

IC29

C36
C48
C42
R9

C16
C1
C33

3
DR3

IC2
R102 DR9

IC12
IC5 IC6 IC24 IC4 T6 X_HEIZER

Q2

IC26
1 C31 1
C49

R28
R77

R78
C26
R45
R46
DR11 X3

R5
X2

R8
D1

D2

2 2
C18

R7
DR8
ME1 ME2

Legend

Connectors (X) LEDs (D)

1 X_POWER  Power supply 4 D1: Not assigned.
Connector 1: green/yellow 5 D2: Flashes in the slice cycle.
Connector 2: blue 6 D17: Watchdog flashing cycle.
Connector 3: black
Measurement points (MP)
3 X_HEIZER  H08, Heater rod.
7 MP1: Ground
Batteries (BA)
2 BA1: Lithium CR 1225 (3 V/42 mAh).

Warning
Risk of injury as a result of an electric shock
Touching live parts will cause an electric shock.
 Unplug the power plug before opening the power supply unit.

Installation location Power supply unit (for processor and heater regulation)

Calibration No calibration required.

Check  Verify the correct position of the connectors.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.14.3 PCB LP 1106 Power supply distribution board

Fig.: PCB LP 1106 – layout E

1 2 3 4 5
↑ Top ↑

18

17

7
16 8

10

11
12
15
13
14

Legend

Connectors (X) 14 X14: Not used.

3 X9: Not used (RS232). 15 X1  Power supply unit.
4 X11  PCB LP 1178⏐X_POWER, power supply 16 X3–X6  EBM, hydraulics, optional CAN
for EBM: modules.
X11, connection 1: 24 V, 17 X2  PCB LP 1104⏐XACCU.
X11, connection 2: ground, 18 X12: Not used.
X11, connection 3: 18 V.
Fuses (SH)
5 X10  PCB LP 1141-3, power supply for
1 F7/SH7: 5 AT, optional CAN modules (24 V)
hydraulics:
2 F8/SH8: 3.15 AT, 24 V
X10, connection 1: 24 V⏐X_LP1106_24V,
6 F5/SH5: 10 AT, X10/connection 1 (24 V)
X10, connection 2: ground⏐X_LP1106_GND,
7 F2/SH2: 10 AT, X10/connection 3 (18 V)
X10, connection 3: 18 V⏐X_LP1106_18V.
8 F6/SH6: 10 AT, X11/connection 1 (24 V)
10 X7  Rechargeable battery:
9 F5/SH3: 10 AT, X11/connection 3 (18 V)
X7, connection 1: 24 V,
11 F9/SH9: 250 mAF, X13
X7, connection 2: ground.
12 F10/SH10: 250 mAF, X14
13 X13: Not used.

Installation location Hydraulics – right side (see chapter 10.2.3.3 on page 265)

Calibration No calibration required.

Check  Verify the correct position of the connectors.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)

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 Chapter 10: Servicing/repair

 Measure the device leakage current (see chapter 10.3.4 on

page 273).

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10.14.4 PCB LP 1126 Heparin pump control board

Fig.: PCB LP 1126 – layout B

C23
1

1
X1 X2
2 1
XHEP_P 2

R28
R17
R29
R18
C20

R19
C24 C25
C21 C22
C15
3
+

C19
IC7

DR4
R11

C16

DR5

DR6
DR7
DR8
DR9 DR3
C18

R20
C12
C26
DR2

DR1
C1
R4

C4

IC5
C5
R12
R36

C11
R14 R23
R30

IC4
R32

T2 R15

R5

C14
R21
IC3

IC2

R13
R35

C3

R8
R22

R27
R33 C7
R34
R7
C2
R31

C6
R9

C17

D8

D6

D4

D2
IC6
XX2 R16
R10

XX1 R24

C13
C10
T1
R1

R2
R6
R3

R25
C8 R26
C9
IC1
S

D7

D5

D3

D1
E

Legend

Connectors (X) 2 XHEP_P  Heparin pump drive.

1 X2  PCB LP 1178⏐X_HEP. 3 X1  Length sensor.

Installation location EBM (see chapter 10.2.2.4 on page 260)

Calibration No calibration required.

Check  Verify the correct position of the connectors.

 Check heparin pump in the EBM Flow Diagram (see chapter 9.3 on
page 224).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.14.5 PCB LP 1131 Monitor operating mode indicator

Fig.: PCB LP 1131 – layout E

R1 R3 D17 R7
D6

D10

D11

D12

D13

D14

D15

D16
D8

D9
D7
R2 R5 R6
R9 R11
2

D27
D18

D20

D21

D22

D24

D25

D26

D28
D19

D29
D30
R8 D23 R10
R12 R14
D32

D33

D34

D36

D37

D39
D31

D38
D41
R15
D35 R13 D40 1
X1 1

Unterseite nicht bestückt.

Bottomside not fitted.

Legend

Connectors (X) LEDs (D)

1 X1  PC board⏐X32. 2 D1–D41 red/yellow/green.

PCB LP 1131 and PCB LP 1131-1 are differentiated by a ferrite core on the cable.

Installation location Monitor (see chapter 10.2.1 on page 256)

Calibration No calibration required.

Check  Verify the correct position of the connectors.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.14.6 PCB LP 1131-2 Monitor operating mode indicator with wireless module

Fig.: PCB LP 1131-2 – layout E

R1 R3 D17 R7
D6

D10

D11

D12

D13

D14

D15

D16
D8

D9
D7

R2 R5 R6
R9 R11
4

D27
D18

D20

D21

D22

D24

D25

D26

D28
D19

D29
D30
R8 D23 R10
D2 D3
D5 R12 R14
D32

D33

D34

D36

D37

D39
D31

D38
D41
R15
R21 R24
D35 R13 D40 1
X1 1

R4
R1917 16 1
64
D1 R16 R17
R18

C1 C17 C4

IC3
C6
C9

IC2
C3

Q1
C13
3
DR4

C10 C11
DR1

IC4

C14
C2

R23
DR3 IC1 C16 IC5

R22
2
32 49
1 1
C8

33 48
X3 X6
C15 C12 R26 R25

Legend

Connectors (X) LEDs (D)

1 X1  PC board⏐X32. 4 D1–D41 red/yellow/green.
2 X3  PCB LP 1161  PC board⏐X12.
3 X6: Not used.

Installation location Monitor (see chapter 10.2.1 on page 256)

Calibration No calibration required.

Check  Verify the correct position of the connectors.

 Check the address and software version of the wireless receiver
(see chapter 9.5.8 on page 248).
 Log on the VenAcc as necessary (see chapter 9.5.8 on page 248).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.14.7 PCB LP 1134 Monitor card reader

Fig.: PCB LP 1134 – layout B

↑ Top ↑

Legend

Connectors (X)
1 X1  PC board⏐X29.

Installation location Monitor (see chapter 10.2.1 on page 256)

Calibration No calibration required.

Check  Verify the correct position of the connectors.

 Insert a ServiceCard to test the card reader.
A T will be displayed in the status bar.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.14.8 PCB LP 1140 Hydraulic sensors

Fig.: PCB LP 1140 – layout D

↑ Top ↑

38 1
a X_OS2 1 a X_OS1 1 a X_SS2 1 a X_SS1 1
b b b b

2
3

1
6
X_S27_28

X_S35

X_S43

1
C191

37 4

X_S45
C187

C190
36
1

5
1

X_S21_47

C207

1
X_S18

X_S04_05_06
35 RL2
6

1
RL6

34 7

X_S29_30
1
1

X_S53
1
X_S01

X_S20

33 8

C210
C215

RL11

1
32 9

1
1
1

X_S22

X_CD7
31 10

X_CD4
RL9
X_CD5

RL10 RL7

30 11
C214
1

29 12
C213
1

RL4
X_CD9
X_S09

X_S17

X_S51

28 13

1
X_S11_36
1

27 14
C209
1
C196

C198
1

X_S10
X_S50
X_PT2

X_PT5

26 15
1
X_S19

C208

25 1 16
C199
1

X_PT7
1

C189
1

X_PT9

X_PT4

X_S08
C188
C197

24 17
X_S15

X_S52

X_PT8
C195

C212

23 18

1
2
1
1
C192

C194
1

X_S16
X_S03

22 19
X_S07
C193

C211
20
b
a 1
b
a 1
21
X_OS X_SS

Legend (see Legend on page 505)

Connectors (X) 20 X_S07  S07.

1 X_SS1/X_SS2  PCB LP 1202-3⏐X1/X2, Safety 21 X_SS/X_OS  PCB LP 1141-3⏐X_SS/X_OS.
system. 22 X_PT8  PT8.
2 X_S35  S35. 23 X_S52: Not used.
3 X_S43: Not used. 24 X_S15  S15.
4 X_S45: Not used. 25 X_S19  S19.
5 X_S27_28: Not used. 26 X_PT2  PT2.
6 X_S04_05_06  S04/S05/S06. 27 X_PT5  PT5.
7 X_S29_30  S29/S30. 28 X_S09  S09.
8 X_S51  S51. 29 X_S17  S17.
9 X_CD4  CD4. 30 X_CD9  CD9.
10 X_CD7  CD7. 31 X_CD5  CD5.
11 X_S50  S50. 32 X_S22  S22.
12 X_PT9  PT9. 33 X_S01  S01.
13 X_S10  S10. 34 X_S20  S20.
14 X_S11_36  S11/S36. 35 X_S18  S18.
15 X_S03  S03. 36 X_S21_47  S21/S47.
16 X_PT7  PT7. 37 X_S53  S53.
17 X_S08  S08. 38 X_OS1/X_OS2  PCB LP 1202-3⏐ X1/X2,
18 X_PT4  PT4. Operating system.
19 X_S16  S16.

Installation location Hydraulics – right side (see chapter 10.2.3.3 on page 265)

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 Chapter 10: Servicing/repair

Calibration/testing  Verify the correct position of the connectors.

 Check the sensors of the following components in the flow diagram:
– S04: Sensor, shunt interlock dialyzer coupling inlet port,
– S05: Sensor, shunt interlock open,
– S06: Sensor, shunt interlock dialyzer coupling outlet port,
– S09: Level sensor, secondary air separator,
– S17: Level sensor, concentrate rinse chamber,
– S19: Level sensor, rinse chamber, bicarbonate,
– S50: Sensor, air separation chamber, bicarbonate,
– S51: Sensor, air separation chamber, concentrate,
– S29: Sensor 1, rinse port,
– S30: Sensor 2, rinse port,
– S18: Sensor, concentrate rinse chamber lock,
– S20: Sensor, bicarbonate rinse chamber lock,
– S21: bibag flap, bag operation position,
– S22: bibag connected,
– S47: bibag flap, cleaning position.

Sensor Flap closed Flap open Flap in central position

No bibag connected No bibag connected bibag connected

S21 Open Open Closed

S22 Closed Closed Open

S47 Closed Open Open

 Calibrate the pressure transducers (S03/S07/S15/S16) (see

chapter 9.4.2 on page 229).
 Calibrate the temperature (see chapter 9.4.5 on page 232).
 Calibrate the conductivity (see chapter 9.4.6 on page 233).
 Calibrate the blood leak (see chapter 9.4.8 on page 234).
 Calibrate the OCM (see chapter 9.4.9 on page 235).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.14.9 PCB LP 1141-3 Hydraulics actuators

Fig.: PCB LP 1141-3 – layout B

↑ Top ↑ ↑ Top ↑
1
30 2
29 3
28
4
27 5
26 6
25 7
24 8
23
22 9
21 10
20 11
19
18
17 12
16
15 13
14

Legend (see Legend on page 505)

Connectors (X) 27 X_VG2_OS4  VS3s, VS5s, VS6s.

1 X_LP1106_18V  PCB LP 1106⏐X10, 28 X_VG2_OS2  V15, V16, V17, V18.
connection 3. 29 X_SS/X_OS  PCB LP 1140⏐X_SS/X_OS.
2 X_LP1106_GND  PCB LP 1106⏐X10,
Jumpers (J)
connection 2.
14 J3: Configure eccentric membrane pump:
3 X_LP1106_24V  PCB LP 1106⏐X10,
1–2 closed: Service,
connection 1.
2–3 closed: Operation.
4 X_VG2_SS2: Not used.
5 X_VG2_OS5  V50, VS2, V51. Fuses (S)
6 X_VG1_SS2  V31, VS4s, VS8s. 20 SH1: 1.5 AT, ±12 V.
7 X_P03  P03. 23 SH2: 1.5 AT, +5 V.
8 X_VG2_SS1  V41, V09, V25, V26.
LEDs (D)
9 X_VG1_OS5  V21, V23, V33, V32.
18 D55: Watchdog (flashes in the event of an error):
10 X_P01  P01.
Flashing 1 x: Safety system too slow,
11 X_VG1_SS1  V40, V24, V22, V35s.
Flashing 2 x: Safety system too fast,
12 X_CAN/X_CAN1  PCB LP 1106⏐X3–X6.
Flashing 3 x: Operating system too slow,
13 X_SOD  P06.
Flashing 4 x: Operating system too fast,
15 X_BIC  P05.
Flashing 5 x: Overvoltage,
16 X_UF  P04.
Flashing 6 x: Undervoltage,
17 X_SPARE  ECMP configuration.
Flashing 7 x: Watchdog signal missing.
19 X_VG1_OS3  V34, V30, V29s, V28.
30 D56: Output switching regulator for 5 V supply
21 X_VG1_OS1  V38, V19, V03, V02.
voltage.
22 X_VG2_OS3  VS7s, VS9s, VS10s.
24 X_VG2_OS1  VF2, V20, V04, VF1.
25 X_VG1_OS4  VS1, VB1, VB2, V36.
26 X_VG1_OS2  V11, V12, V13, V14.

Installation location Hydraulics – right side (see chapter 10.2.3.3 on page 265)

Calibration No calibration required.

Check  Verify the correct position of the connectors.

460 Fresenius Medical Care 6008 SM-EN 11A-2022

 Chapter 10: Servicing/repair

 Check the jumpers.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.14.10 PCB LP 1142 External I/O board

Fig.: PCB LP 1142 – layout B

↑ Top ↑

X_SERVICE
R12
R13
R14
R15

R18
R19
R20
1 8
1

R21
R22
R23
R24
R25
R16
R17
9
C19

15
D3 D4 R8
IC1
R10

C11

C17
C18
2
1

R11

R7 D1 D2 R9

2
X_1145

F1

1
8
X_LAN
2
3
C1 C2 7 1 4
5
R2 R4
C3 R1 R3 Vorne
D5 D6
T2
T1

R5 X_LAN_EXT
C4
R6 D7 D8
D9
T3

6
RL3

2
RL2

4 5
1 3
7
X_AL_EXT

Legend

Connectors (X) Jumpers (J)

1 X_SERVICE  External service connector. 6 J2/J3/J4: Configuration of port assignment.
2 X_1145  PCB LP 1145-1⏐X1_EXT/IO. Default port assignment:
4 X_LAN  PC board⏐X2. J2: 2–3 closed,
5 X_LAN_EXT  External LAN connection. J3: 1–2 closed,
7 X_AL_EXT: Nurse call/external alarm output. J4: 2–3 closed.
Alternate port assignment:
Fuses (S)
J2: 1–2 closed,
3 F1: 0.75 A polyswitch.
J3: 2–3 closed,
J4: 1–2 closed.
8 J1: Response of alarm output when device is
switched off.
J1: 1–2 closed: Default OFF (no alarm)
J1: 2–3 closed: Alternate OFF (alarm)

Installation location Hydraulics – left side (see chapter 10.2.3.2 on page 264)

Calibration/configuring the The alarm line and the ring line of the nurse call are closed or opened
nurse call by one relay each. When an alarm is triggered for a switched on device,
the alarm line is closed and the ring line is opened.
Jumper J1 is used to configure the response of the alarm output for a
switched off device (no alarm or alarm). Jumpers J2, J3 and J4 are used
to select one of two possible port assignments in the 5-pin diode port
(default port assignment or alternate port assignment).

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 Chapter 10: Servicing/repair

Device status Default port assignment Alternate port assignment

J2: 2–3 closed, J2: 1-2 closed,
J3: 1–2 closed, J3: 2-3 closed,
J4: 2–3 closed. J4: 1-2 closed.

1.1 Device is switched off. Ring line Ring line

Default OFF (no alarm)
J1: 1–2 closed ~0Ω ~0Ω
2 2
4 5 4 5

1 3 1 3

∞Ω ∞Ω

Alarm line Alarm line

1.2 Device is switched off. Ring line Ring line

Alternate OFF (alarm)
J1: 2–3 closed ~0Ω ~0Ω
2 2
4 5 4 5

1 3 1 3

~0Ω ~0Ω

Alarm line Alarm line

2 Device is switched on and Ring line Ring line

there is no alarm.
~0Ω 2
~0Ω 2
4 5 4 5

1 3 1 3

∞Ω ∞Ω

Alarm line Alarm line

3 Device is switched on and an Ring line Ring line

alarm was triggered or there is
a power failure. ∞Ω ∞Ω
2 2
4 5 4 5

1 3 1 3

~0Ω ~0Ω

Alarm line Alarm line

Note
No alarm when the alarm line is interrupted
If the alarm line for a switched off device were operated as a normally
open circuit (default OFF), no alarm would be displayed in the event of
a cable break or when a device is taken out of the alarm ring main.
 For safety reasons, operate the alarm line as a normally closed
circuit (alternate OFF).

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Chapter 10: Servicing/repair

 Set jumper J1 to configure the response of the switched off device.

 Set jumpers J2, J3 and J4 according to the port assignment used on-
site.

Check  Verify the correct position of the connectors.

 Check the jumpers.

Check the device status 1.1  Check the resistances on the 5-pin diode port X_AL_EXT according
or 1.2 to the device status 1.1 or 1.2 (see Device status on page 463).
 Switch the device on.
 Simulate treatment.
 Eliminate any signaled alarms.

Check the device status 2  Check the resistances on the 5-pin diode port X_AL_EXT according
to the device status 2 (see Device status on page 463).
 Unplug the power plug.
Message: Power failure Device is battery-operated. – Confirm.

Check the device status 3  Check the resistances on the 5-pin diode port X_AL_EXT according
to the device status 3 (see Device status on page 463).
 Reconnect the power plug.
 If present, connect and check the nurse call.
 If present, check communication with AquaUNO/AquaC UNO H.
 Check the external 24 V supply voltage on connector X_SERVICE
(e.g., by checking whether the rechargeable battery of the UMED is
charging).
 Check the LAN connection on connector X_LAN_EXT.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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 Chapter 10: Servicing/repair

10.14.11 PCB LP 1145-1 Monitor distribution board

Fig.: PCB LP 1145-1 – layout H

1 2 3 4 5 6 7 8 9 10

T1 C12

C13
R24

R60
R59
C56

C14

R44
R57

R36
R72

R67
R66
T6

R37
R1

D12 R11

R38
C53

D13
P1

D1
C35

D9
C55

C15

C29

RL3

RL1
D8
R22 C34 C44 IC9 IC8 R42
C5

C2

X_SCREEN_SENS
R12
R26 R39 R40 R46 IC2

R6 R9
R73 R4

R32
R31
R28
R23
T2

R3

R64
1

R43
R45

1
T7

R69

R15
C23

↑ Top ↑
DR30 DR15

R29

R30
R2 C19 C24 DR16

D11
IC4
DR21

R27
C25
DR22 C28 DR11

R13
R16
R14
DR32

C41
DR25 C10R21 DR6 DR12

R7 C37
C38
X9

DR27 DR26 C31 C22 DR4

DR28 R20 DR10 2 1

IC7
DR7

R5
DR23 DR1

R61
C1
IC1

C36
IC5 X1_EXT/IO X3_LVDS

C39
DR24

R10
C11
DR5

R8
DR31 8 D7 DR8
DR29 DMC R68 1 DR9 1 2
DR2

R70
R71
R56

R50
C59 X7 DR3
C58 C33 C32 R54 R63 R17

R49

R48
C57 C62 R53
DR14 DR18 DR17 R19 C60 T4 R55

+
DR34 C61
1

DR33 1 2 T3
C21 b 1
X5

X2_LS/MIC X10_DISPLAY X6_BACKLIGHT

1 XCPU2 R58
DR35 2 1
MXJ

a 1 R65 DR19

Legend

Connectors (X) 8 X3_LVDS  PC board⏐X33.

1 X5/X9  Touch screen, keys and LEDs on 9 X6_BACKLIGHT  Screen backlight.
monitor front. 10 X_SCREEN_SENS  PCB
3 X2_LS/MIC  Loudspeaker and microphone. LP 1150⏐XP1/XP2/XP3
4 X7  PCB LP 1104⏐X2.
Potentiometers (P)
5 XCPU2  PC board⏐X23.
2 P1: Loudness of the audible alarm (set to
6 X1_EXT/IO  PCB LP 1142⏐X_1145.
maximum when shipped).
7 X10_DISPLAY  Data to screen.

Note
Monitor can be destroyed by wrong voltage
 Check the solder bridges of PCB LP 1104 against the compatibility
matrix (see chapter 10.9.4.2 on page 305).
 Only do this with the device switched off (without the solder bridges,
voltage supply is 24 V).

Note
Monitor can malfunction if connected with wrong cables
 Only use the supplied wiring for the screen and the backlight (see
chapter 10.9.4.2 on page 305).

Installation location Monitor (see chapter 10.2.1 on page 256)

Check  Refer to the monitor compatibility matrix (see chapter 10.9.4.2 on

page 305).
 Verify the correct position of the connectors.
 When switching on the device, check the operating status indicator
and LEDs on the monitor front.
 Insert a ServiceCard to test the card reader.
A T will be displayed in the status bar.
 Select the UPDATE menu.

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Chapter 10: Servicing/repair

 Update the software version of the EBM safety system to test the
CAN bus.
 Consecutively press and hold the Audio Paused, Blood System
Start and Blood System Stop buttons until the target point appears
at the upper left of the screen.

Calibration  Calibrate the touch screen (see chapter 9.4.1 on page 228).
 Check the sound volume potentiometer P1 (set to maximum when
shipped).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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 Chapter 10: Servicing/repair

10.14.12 PCB LP 1150 Screen failure sensor

Fig.: PCB LP 1150 – layout 0

↑ Top ↑

Legend

Connectors (X)
1 XP1/XP2/XP3  PCB LP 1145-1⏐X_SCREEN_SENS.

Installation location Monitor – monitor front (see chapter 10.2.1 on page 256)

Calibration No calibration required.

Check  Verify the correct position of the connectors.

 Check the signal from the screen failure sensor (see chapter 9.5.1
on page 241).

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.14.13 PCB LP 1178 I/O board

Fig.: PCB LP 1178 – layout G

↑Top↑ 1
C36

31

DR8
2

F1
C20
SH1

2
1
C38 DR4
+

+
IC6

1
R3

30 3

C24
X_HEP
R9 C12

X_DOOR

1
2
C212

DR123
D10

C21
C32 R29 D5

X_ASK_2
C205
R33
+ C6

R7
4

+C25
29

X_LVP

C201
DR9 IC3

F3
C1

R11

C4
1
C179
R398

X_POWER
C183
IC49 DR1
C10

5
X_ART_CL
1

2
1
DR5

X_V902_DN
28

R49
R48
R45
R38
R4

R1
1
C206 C207
R54 C184

X_ASK
R396

DR3
C13 IC1

T41
DR12 C39 C34

6
DR10

R275
DR11 R61 C14
+
27
X_VEN_CL

C31
IC11
1

DR13 C7

R22
R21
X_SN_TANK

R18
C211 C8

T3
7
D13 D8
1

DR6

F4
2
X_42

R5
X_SP_HALL

26
R35 1 8

F2

R10
D14

T4
1

R46
R40
R34
X_PNEUM
8
D9

C180
R50

R6
R411
R62

R39
R36
C37 C33

25

X_MOD_LEAK
X_SP

1
C209

2
1

1
C28
IC10
1

X_CAN_MASTER
X_BP_HALL

X_CAN_2

X_CAN_3
6
24
R55

10

DR7
2
1

R51

X_DOOR_CLOSE

C191
1
1

X_SN

23 11
R72

C192
T8
D11
2

R73 R75
1

T12
X_BP

X_ABD

C208 R12
R58

12
R63 R64
C210

R26
R14

R30
T6
R79

R13 R15
T9

T1 T2
22

R41
R76

T5
R59

T7
IC7
11

C35
12

R65
R77

R31
R27
T10
D15

R66 13
J1

R78

R28
R25
R24
R23
R19
R16
R57
R56
R53
R52
R47
R43
R42
R37
R95
R94
R93
R92
R91
R90
R88
R87
C181
R104
R103
R102

C182

4
R111
R110
R109
R108

R105
R106

R67 D12

21
+
C52

C27
C26
C23
C22
C19
C18
D16
+

R98 R397 T11 R68

R82
C48

R85

14
R101 R99 R97 R96 R74 R71 R70 C15
C50

C40

C29
C42
C46

R2
IC24 IC22 IC20 IC18 IC16 IC14 IC12 IC8 IC4 IC2

20 15
C44 R84

R89 R81 R69 R44

C51

C16 R8
C55
R80
R86

R60

R83 R17
C53

R32
IC25

19
D7 D6 D4

16
IC23 IC21 IC19 IC17 IC15 IC13 IC9
R100

R112 C54 IC5 D2 D1

C47

C17
C43

C41
IC26

C45

C30

D3
R107

C11
C9
C5
R113

18 17

C3
C2
b b b b
1 X_OS1 a 1 X_OS2 a 1 X_SS1 a 1 X_SS2 a

Legend

Connectors (X) 29 X_DOOR  PCB

4 X_POWER  PCB LP 1106⏐X11. LP 1179⏐X_DOOR1/X_DOOR2.
5 X_V902_DN  V902, without Single-Needle 30 X_HEP  PCB LP 1126⏐X2.
(option).
LEDs (D)
8 X_SN_TANK  PCB LP 1180⏐X1 (option).
2 D20: Watchdog (flashes in the event of an error):
9 X_CAN_MASTER  PCB LP 1106⏐X3–X6.
Flashing 1 x: Safety system too slow,
10 X_CAN_3  BTM (option).
Flashing 2 x: Safety system too fast,
11 X_CAN_2  BVM (option).
Flashing 3 x: Operating system too slow,
12 X_MOD_LEAK  Leakage sensor.
Flashing 4 x: Operating system too fast,
13 X_PNEUM  Pneumatic unit.
Flashing 5 x: Overvoltage,
14 X_DOOR_CLOSE  Hall sensor, door lock.
Flashing 6 x: Undervoltage,
15 X_SN  Single-Needle unit (option).
Flashing 7 x: Watchdog signal missing.
17 X_SS1/X_SS2  PCB LP 1202-3⏐X1/X2, Safety
system. Jumpers (J)
18 X_OS1/X_OS2  PCB LP 1202-3⏐X1/X2, 16 J1: Configure cassette sensors:
Operating system. 1–2 closed: Jenoptik (transparent),
19 X_ASK  Substituate unit (milled part). 1–2 open: Hund (black),
20 X_ASK_2  Substituate unit (injection-molded 3–4 closed: electrical sensors (Jenoptik or Hund),
part). 3–4 open: Mechanical sensors.
21 X_LVP  Actuator-sensor unit.
Fuses (F/SH)
22 X_BP  Blood pump.
1 F1: 1.5 A SMD fuse, 5 V supply voltage.
23 X_ABD  Air bubble detectors.
3 F3: 2.0 A SMD fuse, 12 V supply voltage.
24 X_BP_HALL  Hall sensors, blood pump.
6 F2: 1.5 A SMD fuse, substituate unit.
25 X_SP  Substituate pump.
7 F4: 1.5 A SMD fuse, watchdog.
26 X_SP_HALL  Hall sensors, substituate pump.
31 SH1: 0.25 A SMD fuse, door lighting.
27 X_VEN_CL  Venous occlusion clamp.
28 X_ART_CL  Arterial occlusion clamp.

Installation location EBM (see chapter 10.2.2.4 on page 260)

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 Chapter 10: Servicing/repair

Calibration/testing  Verify the correct position of the connectors.

 In the SETUP  Settings Hydraulics menu, check the Installation
altitude field.
 In the CALIBRATE  Cassette sensors menu, select the Start
calibration field.
 Make the EBM completely ready and simulate a dialysis treatment.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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Chapter 10: Servicing/repair

10.14.14 PCB LP 1179 LED board

Fig.: PCB LP 1179 – layout B

↑Top↑

1
2
3
4
5

Legend

Connectors (X) 5 X_RLS_SUB_CH: Not used.

1 X_RLS_DEAIR: Not used.
LEDs (D)
3 X_DOOR1 (blue)  PCB LP 1178⏐X_DOOR.
2 D1/D2/D3: door lighting.
4 X_DOOR2 (green)  PCB LP 1178⏐X_DOOR,
door lighting.

Installation location Door (see chapter 10.11.1.5 on page 327)

Calibration No calibration required.

Check  Verify the correct position of the connectors.

 Switch the device on.
 Make sure the 3 LEDs light up briefly.

Final tasks No final tasks needed.

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10.14.15 PCB LP 1180 SN tank

Fig.: PCB LP 1180 – layout A

1
DR1

1
2
X2

R2

X1
3
DR2

1
C1
R1
C2
Legend

Connectors (X) Sensors

2 X1  PCB LP 1178⏐X_SN_TANK. 1 R2  S903, pressure transducer, air expansion
3 X2  S904, temperature sensor, air expansion tank.
tank.

Installation location EBM (see chapter 10.2.2.4 on page 260)

Calibration No calibration required.

Check  Verify the correct position of the connectors.

 Perform the Single-Needle pneumatics test (option) (see
chapter 9.5.3.2 on page 243)

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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10.14.16 PCB LP 1186 Power supply CPU (serial number section WMT)

Fig.: PCB LP 1186 – layout G

X_POWER
R46

1
R1
R2
R3

T1
1

R6
-

R8

R5
R4
T2

C1

D1

C3 C2
R7

R213
R9

IC1
3

IC2
DR1
R56

C7
C6
C5
BAH1

T4
R12
R13

C13
D3

R15

T5
C69
R23
R16

D4 D5
C15

IC3

R17
C8

R18
IC4 C10

R14
R19 R20 R22
R150

C91
C11
C73

C9

R24
C16

R25
C12 D30
100

R29
76

R26
IC5
R158 R31 R21

IC6
75

R205
R139

D6
R27
1

C22 D42

C19

C14
R138

R28 T6
C20 D29

R140
R30
D24 R32
+

T23
R42 R33

D38
R35 R192
C75

R44
C17 R157

R50
IC9
IC8
R41 C21

+
R53
C70
R52

C68 R34 T7
IC7
R149
R137

C23
R47 D8

IC11
IC32

C92 D40

R206
Q1
C25
R40 R48 R39

R36
R37
R38

R201
R200
C93
R45 C27 D7

R141
R142
C24
R186
C28
C29

D28

T26 T27 R43

IC12 IC13

C26
R61

C77
D36 T11 R69 R70

R202
R204
R203
D39 T36
T34 T10

D26

R54
R185 R55
C58 51
T8
25

R57 R60
26

50

C32 IC10

IC15
IC28

R58 C31 R63 D32 D27 R65 R68

C90 C33

R64
Q2 R143 C37 R83 D11
R189

C18 C72
R165

D35
R128

R199

C39

R144 C65 R66

R127

R51 C57 R74

C86
C36
R72

R84
R166 C34
R187
R188

R197 T14 C35

D14

C95
T13 IC34

R73
R196
R81
D12 R80 IC36

IC17
D37 R79
C42

C40

R86 T12
D15

R88

R82
D22

D13
R103 R92

R97
IC18

R89 R90 R91

IC21
IC20
IC19

C43

R93
C41

R100
R94

R87 R96

T15
R101

R212 R95
C45

R190 RL1
R102
D21

R211

R210
R207
R208
R99

C30
DR8

DR9

C46

R98
C47

R59 C51
R179

R209 R104
D17

D23 D41
IC14

IC23
D16

R107 R180 R114 R110 T16

C85

D19
R109

06
C56
C59
IC25
C53 T17
T18

T33

R1
C66
R126
R115

R184
R182

R132

R181 C60
R112 R119 C50 C96

RL2
R113 R129

T21
T20
R120

T32 R183 R124

R170 R171

C62 C63
DR3

DR6

R147 R146 R131 R130

C61

T24
C67 D18 R161
C48

R116 R117
R194
R193

C74 R133
R167

DR4 C64 R176 R105

R172

R195 D20
R121
R123
C80

R122
C44
DR7

C71
R134

DR10
T25
R153
R178
R151
R152

DR5

2
C81

R177 T31
R198 C94
R169
R168

X_HEIZER
D33

R175
IC26 1 R135 R136
C76

T19 T35
T22

X3
C83

IC35 C82
C84

2
D34
R174

R191
R173

Legend

Connectors (X) Batteries (BA)

1 X_POWER  Power supply 3 BAH1: Lithium CR 2032 (3 V/230 mAh).
Connector 1: green/yellow
Connector 2: blue
Connector 3: black
2 X_HEIZER  H08, Heater rod.

Warning
Risk of injury as a result of an electric shock
Touching live parts will cause an electric shock.
 Unplug the power plug before opening the power supply unit.

Installation location Power supply unit (for processor and heater regulation)

Calibration No calibration required.

Check  Verify the correct position of the connectors.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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 Chapter 10: Servicing/repair

10.14.17 PCB LP 1202-3 Controller board (C167)

Fig.: PCB LP 1202-3 – layout A

Legend

Connectors (X) LEDs (D)

2 X1/X2 (5 connectors): 1 D1: Watchdog flashing cycle.
2.1  PCB LP 1178⏐X_OS1/X_OS2
2.2  PCB LP 1178⏐X_SS1/X_SS2
2.3  PCB LP 1140⏐X_OS1/X_OS2
2.4  PCB LP 1140⏐X_SS1/X_SS2
2.5  PC board⏐X20/X21

Installation locations Monitor (see chapter 10.2.1 on page 256):

– Safety system.
EBM (see chapter 10.2.2.4 on page 260):
– Operating system in the EBM electronics plate, on the left.
– Safety system in the EBM electronics plate, on the right.
Hydraulics (see chapter 10.2.3.3 on page 265):
– Operating system in the electronics chassis, at the right.
– Safety system in the electronics chassis, at the left.

Copying the software of The following must be observed when copying the software of the
the M2 monitor safety monitor safety system M2:
system
 Remove jumper J1 on PCB LP 1104 (display of boot messages).
 Switch the device on.
 Park the Internal error message and select the Status field.
 Wait until fields 1 and 2 are displayed.

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Chapter 10: Servicing/repair

 Enter 2 x 112 to go to the Service menu.

 Select the UPDATE menu.
 Update the software version of the monitor safety system.
 Reconnect jumper J1 (1–2) operation (to suppress the boot
message) to PCB LP 1104.

Calibration Monitor safety system: No calibration required.

EBM:
 In the SETUP  Settings Hydraulics menu, check the Installation
altitude field.
 In the CALIBRATE  Cassette sensors menu, select the Start
calibration field.
 In the CALIBRATE  Substituate unit menu, select the Start
calibration field.
Hydraulics:
 Create connection between PC Service Software and the device
with read and write authorizations (see chapter 5.5.2 on page 135).
 If available, transfer current calibration data to the corresponding
system (operating or safety system) using the PC Service Software.
 Follow the calibration instructions displayed in Service mode.
 If the hydraulics operating system has been replaced, the operating
hours must be synchronized using the PC Service Software.

Check No check required.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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 Chapter 10: Servicing/repair

10.14.18 PC board

Fig.: PC board with ETX revision 5.0 / baseboard revision 8.0

↑ Top ↑

11

10

1
9

2
5

4
3

Legend

Connectors (X) 9 X32  PCB LP 1131⏐X1.

1 X22  PCB LP 1104⏐X1. 10 X24: Jumper for the touchscreen capacity.
2 X20/X21  PCB LP 1202-3⏐X1/X2. 6–7 closed: touchscreen capacity for 6008.
3 X23  PCB LP 1145-1⏐XCPU2. 11 X33  PCB LP 1145-1⏐X3_LVDS.
5 X19  External CF card slot.
Batteries (X)
6 X2  PCB LP 1142⏐X_LAN.
4 X100: Lithium CR 2032 (3 V).
7 X29  PCB LP 1134⏐X1.
8 X12  LP 1161  PCB LP 1131-2⏐X3.

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Chapter 10: Servicing/repair

Note
PC boards with different LVDS frequencies
Depending on the hardware state, a PC board with an LVDS frequency
of either 40 MHz or 62 MHz needs to be installed.
 Observe the matrix for selecting spare parts (see chapter 10.9.4.1
on page 302).

Installation location Monitor (see chapter 10.2.1 on page 256)

Calibration/testing:
 Verify the correct position of the
connectors.
1  Make sure the CF card is in the correct
position.
 Make sure that the jumper (1) in connector
X24 is set to pins 6 and 7.

 Check software version.

 Calibrate the touch screen.
 Set the date and time.
 Create connection between PC Service Software and the device
with read and write authorizations (see chapter 5.5.2 on page 135).
 Transfer the serial number with the PC Service Software.
 Synchronize the operating hours via the PC Service Software.

Final tasks  Measure the protective earth resistance (see chapter 10.3.3 on
page 269).
 Perform the T1 test (see chapter 10.3.1 on page 268)
 Measure the device leakage current (see chapter 10.3.4 on
page 273).

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 Chapter 10: Servicing/repair

10.15 Troubleshooting

10.15.1 Troubleshooting with dark display

Display is dark Replace PCB LP 1202-3.

Update the software version of the monitor
safety system (see chapter 10.14.17 on
page 473).
PCB LP 1104 Perform the T1 test and a disinfection.
Remove jumper 1.
No
Display lights up and shows D1 on PCB LP 1202-3
start screen. flashes.

Replace PC board.
Calibration (see
chapter 10.14.18 on
page 475), T1 test
and disinfection.

Display shows white No

characters on black
background. Replace Compact
Flash. Observe slot Problem
on PC board. corrected?

Adapt setup data to

hospital requirements.
Yes Perform the T1 test
and a disinfection.

D3 and D5 flash. D3 and D5 are lit. Replace

Unplug X2 connector PCB LP 1145.
on PCB LP 1104.

Display remains dark. Check LEDs and

fuses of
PCB LP 1104. Continued on next page

PCB LP 1104
Reconnect jumper 1.

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Chapter 10: Servicing/repair

Check, replace F2. Check Check, replace F3. Check

Continued PCB LP 1145, inverter PCB LP 1145, inverter
and monitor. and monitor.

Check PCB
LP 1106, PSU,
and connecting
cable between D11
PCB LP 1106 and No on No No
PCB LP 1104. PCB LP 11
04 is lit D6 D4
on on
PCB LP 11 PCB LP 11
Yes
04 is lit 04 is lit
Check, replace
F1. Check
PCB LP 1202-3 D2 Yes Yes
(M2), No
on
PCB LP 1142, PCB LP 11
PCB LP 1145, 04 is lit
card reader, and
cables in monitor Yes
support arm.
D5 D3 Yes
Yes
on on
PCB LP 11 PCB LP 11
D1 04 is lit 04 is lit
on
No PCB LP 11 No No
04 is lit

Yes Replace PCB LP 1104.

Observe solder bridges.
Replace PC board.

D16 Yes
on PC
board
flashes.
Check monitor or
No cable connections.
Replace PC board, PCB Replace PCB LP 1104.
LP 1104 and entire Observe solder bridges.
monitor.

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 Chapter 10: Servicing/repair

10.15.2 Troubleshooting in case of unclear crashes and suspected CAN bus problems

PCBs LP 1145 and LP 1141-3 each feature 2 CAN terminating resistors.

Fig.: CAN bus connections in the device

Monitor

PCB LP 1202-3 SS PC board OS PCB LP 1145

PCB LP 1104

Power supply unit/housing

PCB LP 1106 BPM (option) PCB LP 1142

EBM

PCB LP 1202-3 OS PCB LP 1178 PCB LP 1202-3 SS

BVM (option) BTM (option) Substituate unit

Hydraulics

PCB LP 1202-3 OS PCB LP 1140 PCB LP 1202-3 SS

PCB LP 1141-3

Concentrate pump Bicarbonate pump UF pump

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Chapter 10: Servicing/repair

Problem with CAN bus?

Values change to
Replace PCB LP 1202-3.
around 120 ohms
and remain stable? Yes

No
Switch off the device.
Refit PCB LP 1202-3
Re-attach all connections.
(monitor/SS).

All CAN components are fitted.

Remove LP 1104.

Constantly measure resistance

(service/diagnostic plug)
between PIN 1 / PIN 2 and
between PIN 3 / PIN 4.
Rear of device
Values change to
around 120 ohms Replace PCB LP 1104.
and remain stable? Yes

All values are No problems with terminating

resistors. No
around 60 ohms
and remain stable? Yes
Reconnect PCB LP 1104. Re-attach all connections.

No

Pull off connecting cable from

PCB LP 1104 (XACCU) to PCB
Pull off cable connecting
LP 1106.
PCB LP 1145 (XCPU2) to PC
board.

Values change to Continued on next

around 120 ohms page Values change to
and remain stable? Yes
around 120 ohms Replace PC board.
and remain stable? Yes

No
No
Remove PCB LP 1202-3
(monitor/SS). Re-attach all connections.
Replace PCB LP 1145 or 1142.

Re-attach all connections.

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 Chapter 10: Servicing/repair

Refit connecting cable from

PCB LP 1104 (XACCU) to PCB
LP 1106.

Pull off BPM CAN cable for

PCB LP 1106.

All values are Replace BPM or CAN cable.

around 60 ohms
and remain stable? Yes

No

Pull off BTM CAN cable for Re-attach all connections.

PCB LP 1178.

All values are

Replace BTM or CAN cable.
around 60 ohms
and remain stable? Yes

No

Pull off BVM CAN cable for Re-attach all connections.

PCB LP 1178.

All values are All values are

Replace BVM or CAN cable. Replace substituate unit or
around 60 ohms around 60 ohms
Yes Yes CAN cable.
and remain stable? and remain stable?

No No

Unplug substituate unit Re-attach all connections. Leave all CAN Re-attach all connections.
connector from PCB LP 1178. cables/connectors
disconnected.

Continued on next page

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Chapter 10: Servicing/repair

Pull off CAN cable from

PCB LP 1106 to
PCB LP 1141-3.

Values change to
Continued on
around 120 ohms
next page
and remain stable? Yes

No

Pull off CAN cable from

PCB LP 1106 to PCB LP 1178.

Values change to Refit CAN cable from

around 120 ohms PCB LP 1106 to PCB LP 1178.
and remain stable? Yes

No

Replace PCB LP 1106,

LP 1104, LP 1105-1 or the Remove PCB LP 1202-3
power supply unit if the (EBM OS/SS).
resistance fails to be stable at

Re-attach all connections.

Values change to
around 120 ohms Replace PCB LP 1178.
and remain stable? No

Yes

Measure the resistance with Refit PCB LP 1202-3

one connected PCB each time. (EBM OS/SS).

Replace the PCB concerned if

the resistance fails to be stable Re-attach all connections.
at approx. 120 ohms.

Re-attach all connections.

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 Chapter 10: Servicing/repair

The error cause is in the

hydraulics.

Refit CAN cable from

PCB LP 1106 to
PCB LP 1141-3.

Pull off concentrate,

bicarbonate and UF pumps
from PCB LP 1141-3.

Values change to Remove PCB LP 1202-3

around 60 ohms (hydraulics OS/SS).
and remain stable? No

Yes

Values change to Measure the resistance with

around 60 ohms one connected PCB each time.
Measure the resistance with
and remain stable? Yes
one connected pump each
time.
No

Replace the pump concerned if Replace PCB LP 1141-3 or Replace the PCB concerned if
the resistance fails to be stable PCB LP 1140 if the resistance the resistance fails to be stable
at approx. 60 ohms. fails to be stable at approx. at approx. 60 ohms.
60 ohms.

Refit PCB LP 1202-3

Re-attach all connections. (hydraulics OS/SS). Re-attach all connections.

Re-attach all connections.

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Chapter 10: Servicing/repair

10.15.3 Example pictures of improperly installed cassette contact mats

This chapter shows some example pictures of improperly installed

cassette contact mats and the possible consequences of this.

Fig.: Example 1 of an improperly installed cassette contact mat

Possible leaks between the cassette

contact mat and cassette

Pressure sensors and level detectors

do not operate correctly

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 Chapter 10: Servicing/repair

Fig.: Example 2 of an improperly installed cassette contact mat

Possible leaks between the cassette

contact mat and cassette

Pressure sensors and level detectors

do not operate correctly.

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Chapter 10: Servicing/repair

Fig.: Example 3 of an improperly installed cassette contact mat

Possible leaks between the cassette

contact mat and cassette

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 Chapter 11: Functional description

11 Functional description

11.1 Complete system

Monitor

RS 232
OS SS

CAN_OS CAN_SS
EBM

RS 232
OS SS

Hydraulics

RS 232
OS SS

Power supply unit

OS

Options

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Chapter 11: Functional description

11.2 Overview of PCBs

Monitor Monitor card reader

Monitor LP 1134
operating mode indicator
Controller board LP 1131
(C167)

Housing rear panel

Monitor
LP 1202
screen failure sensor
LP 1150 Monitor,
external
OS connectors
Monitor power supply Monitor
PC distribution board LP 1142
LP 1104
LP 1145

Power supply unit

Power supply controller

LP 1186/LP 1105

Power supply distribution board

Power supply LP 1106

Tank
1178 1180

Hydraulics

Controller board Controller board

(C167) (C167)
LP 1202 LP 1202

Sensor board Hall sensor Hall sensor

rinsedoor rinsedoor
LP 1135 LP 1135
LP 1140

Actor board

LP 1141
Pump control Pump control Pump control
LP 952 LP 952 LP 952

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 Chapter 11: Functional description

11.3 Monitor

 Block diagram

Monitor
red yellow green

Monitor operating mode indicator

LP 1131 Micro-
TFT-Screen phone
Monitor

OI
screen
Touch failure sensor
LP 1150 Loud-
speaker
Monitor
card
reader
LP 1134

Alarm Blood Blood

system system On/Off
Mute
Stop Start

Monitor distribution board

LP 1145

OS OS, SS, CAN LP 1106

24V LP 1106
Monitor
power supply On/Off LP 1106

LP 1104
OS

SS SS
Controller board
(C167)
PC
LP 1202
LAN

Monitor, external connectors

LP 1142
Housing rear panel
CAN

RS 232 24 V

LAN Service/Diagnostics Alarm output

RJ 45 DSUB Diode socket
15-pin 5-pin

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Chapter 11: Functional description

 Description

PCB LP 1104 houses the power supply for the entire monitor unit.
Independent voltages are generated from the +24 V supplied by the
power supply unit. +5 V for the OS/SS, +12 V or +5 V for the backlight,
+12 V / +5 V or 3.3 V for the TFT electronics.
PCB LP 1142 provides the signal connections to the peripheral
equipment. It has a LAN (Ethernet) port. A service/diagnostics plug is
available for technicians. It comprises a serial port (RS232) with +24 V
voltage. An alarm output for the nurse call is also present.

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 Chapter 11: Functional description

11.4 Power supply unit

 Block diagram for power supply units with serial number section VMA (PCB LP 1105-1)

90 - 264 V/AC
Output 1
(+24 V/20A) Power Supply

Output 2
(+18 V/14A) Rating
Output
480 W
Battery
(+24 V/7Ah)

Output 3 (+5 V/Standby)

Power fail
Battery test

+24 V

90 - 264 V/AC
On/Off

Power Supply
distribution board
LP 1106

Push-button OS 0-100 % Heater

On/Off control

CAN
ON/OFF

Heater Heater
(of hydraulics) relay

Power Supply - Control

LP 1105-1

Power supply unit

Heater rod

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Chapter 11: Functional description

 Block diagram for power supply units with serial number section WMT (PCB LP 1186, PCB
LP 1187)

90 - 264 V/AC
Output 1
(+24 V/20A) Power Supply - Power electronics
LP 1187
Output 2
(+18 V/14A) Rating
Output
480 W AC/DC Converter
Battery
(+24 V/7Ah) Output 24,5 V/DC

supply
Input 90 - 264 V/AC
+5 V

Battery test
Power fail

90 - 264 V/AC
On/Off

Power Supply
distribution board
LP 1106

Push-button OS 0-100 % Heater

On/Off control
LED (monitor)
CAN
ON/OFF

Heater Heater
(of hydraulics) relay

Power Supply - Control

LP 1186

Power supply unit

Heater rod

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 Chapter 11: Functional description

 Description

Power is supplied by a primary-switched power supply unit. This means

it does not require a power transformer and can be connected to all
common line voltages without switching. The charging circuit integrated
in the power supply unit charges the rechargeable batteries to provide
battery backup in the event of a power failure. If a power failure occurs,
the +24 V supply is buffered by the rechargeable batteries.
There is a processor on the PCB LP 1186 or PCB LP 1105-1. This
processor regulates and actuates the heater and the On/Off logic for the
entire device. A control chip with pulse-pause modulation controls the
heater rod via two triacs. The data required for the control is sent via the
CAN bus to the processors.

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Chapter 11: Functional description

11.5 Extracorporeal Blood Circuit Module (EBM)

 Block diagram

Substituate pump

Venous occlusion clamp

Blood pump

Arterial occlusion clamp

Hall sensors, substituate pump

Cassette sensors BTM (blood temperature monitor)

Hall sensors, blood pump

Air distributor board

BVM (blood volume monitor) Arterial ABD/OD

Venous ABD/OD
Substituate unit

System compressor
Heparin pump

Single-Needle compressor (option)

Single-Needle air expansion tank
(option) with temperature sensor
pressure transducer Door electronics

Valve V902 VDeair Leakage sensor

X_CAN_3

X_CAN_2

X_V902_DN

X_HEP X_SN_TANK X_MOD_LEAK X_DOOR_CLOSE

X_ASK_2 X_ASK X_SN

Alternative
X_PNEUM

X_LVP X_SP_HALL X_BP_HALL X_ABD

X_DOOR X_ART_CL X_VEN_CL X_SP X_BP

+5 V +12 V +12 V_POW +18 V_SW +24 V_SW

DC/DC +12 V linear DC/DC

PCB LP 1106 +18 V

Change-over
switch
PCB LP 1106 +24 V

PCB LP 1106 CAN

X_CAN_MASTER
WD

CAN SS CAN OS RS-232

Operating system Safety system (SS)

(OS) PCB LP 1202-3 Controller board
PCB LP 1202-3 Controller board (C167)
(C167)

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 Chapter 11: Functional description

 Description

The power supply unit supplies the PCB LP 1178 with +24 V and +18 V
via PCB LP 1106. The +5 V, +12 V and +12 V_POW voltages are
generated on PCB LP 1178. The +18 V_SW and +24 V_SW is enabled
via the watchdog.
The sensor signals are routed via PCB LP 1178 to the OS and the SS
where they are evaluated. The OS controls the actuators via PCB
LP 1178. The SS independently controls the switching of the
+24 V_SW, +18 V_SW and +12 V_POW to the actuators via PCB
LP 1178.
The CAN buses are distributed from the OS and the SS via PCB
LP 1178. PCB LP 1178 is connected to PCB LP 1202-3, OS via the
plug connectors X_OS1 and X_OS2, and to PCB LP 1202-3, SS via the
plug connectors X_SS1 and X_SS2.
The serial connection between the OS and the SS is also made via PCB
LP 1178.

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 

496
Air distributor board

12 1

2 3 6
7
Pneumatic
unit
11.6 Pneumatics
Chapter 11: Functional description

Pneumatics circuit diagram

4
5
A B C D 17
10 9 16 8 Cassette contact mat
With Single-Nee-
Air expansion tank
dle (option)

Cassette system 19
E
11 H I
Door
15
20 Single-Needle unit
J
F G

13 14
Without Single-Needle
(option)

Vent valve

Fresenius Medical Care 6008

18

SM-EN
11A-2022
 Chapter 11: Functional description

Legend
Tubing
1 Pneumatic unit (1)  Hydrophobic filter F_NBC_2 – Tubing length 200 mm
2 Pneumatic unit (2)  Air distributor board vacu – Tubing length 320 mm
3 Pneumatic unit (3)  Hydrophobic filter F42 – Tubing length 800 mm
4 Pneumatic unit (4)  Positive pressure vessel – Tubing length 850 mm
5 Pneumatic unit (5)  Negative pressure vessel – Tubing length 850 mm
6 Pneumatic unit (6)  Blue tube to hydraulics system – Tubing length 1020 mm
7 Pneumatic unit (7)  Hydrophobic filter F_NBC_1 – Tubing length 130 mm
8 Air distributor board brake  Substituate pump brake – Tubing length 280 mm
9 Air distributor board actuator  Pressure actuator – Tubing length 180 mm
10 Air distributor board actuator  Emergency unlocking valve – Tubing length 180 mm
11 6008 rear panel  Emergency unlocking valve – Tubing length 1280 mm
12 Air distributor board press  Hydrophobic filter F_NBC_2 – Tubing length 100 mm
13 Vent valve V902  Cassette deaeration port – Tubing length 500 mm (option)
Condensate separator  Cassette deaeration port – Tubing length 65 mm (option)
14 Single-Needle unit BACK  Condensate separator – Tubing length 510 mm (option).
The pneumatic tubing BACK is black.
15 Single-Needle unit SN-TANK  Air expansion tank – Tubing length 580 mm (option)
16 Air distributor board brake  Blood pump brake – Tubing length 180 mm
17 Air distributor board coupling  Hydrophobic filter – Tubing length 80 mm
F_NBC_3
18 Vent valve V902  Atmosphere – Tubing length 150 mm (option)
19 Cassette coupling port  Hydrophobic filter F_NBC_3 – Tubing length 500 mm
20 Single-Needle unit FWD  Condensate separator – Tubing length 415 mm (option).
The pneumatic tubing FWD is blue.
Components Valves (V)
A Cassette valve, venous insertion site V001 VPre
B Predilution cassette valve V002 VPost
C Postdilution cassette valve V003 VSN
D Cassette valve, Single-Needle V004 VInject
E Pressure actuator V101 VOver
F Blood pump brake V102 VUnder
G Substituate pump brake V103 VHydPU
H Single-Needle chamber on cassette system V105 VCoupling
I Cassette coupling port V106 VUnlock
J Cassette deaeration port / Single-Needle port V201 VActuator
V202 Emergency unlocking valve
Compressors (M) V301 VBrake
M101 Compressor (pneumatic unit) V901 VBypass1 (option)
M901 Compressor (Single-Needle unit (option)) V902 VDeair
V903 VBypass2 (option)
Sensors (S)
S101 Pressure transducer POver Filters (F)
S102 Pressure transducer PUnder F_NBC_1 Hydrophobic filter, air intake
S103 Cassette coupling sensor F_NBC_2 Hydrophobic filter, air distributor board
S104 Pressure transducer PDiff F_NBC_3 Hydrophobic filter, cassette coupling port
S902 Pressure transducer PLine (option)
S903 Pressure transducer PTank (option)
S904 Temperature sensor Temp (option)
S905 Pressure transducer PAbs (option)

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Chapter 11: Functional description

11.6.1 Pneumatics overview with current version of pneumatic unit (injection-molded

part)

Fig.: Pneumatics overview with Single-Needle (option) and current pneumatic unit

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 Chapter 11: Functional description

15

12

10
16
17

11

19
14
7
1
2 20
3
5
6

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Chapter 11: Functional description

11.6.2 Pneumatics overview with preceding version of pneumatic unit (milled part)

Fig.: Pneumatics overview with Single-Needle (option) and preceding pneumatic unit

15

9
8

12

10
16

17
2

19
14

20

6
11
4

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 Chapter 11: Functional description

 Description

The pneumatic unit is located in the EBM. There it controls the pressure
actuator, the rotor brakes and the cassette valves. It also ensures
coupling of the sensors and of the cassette system to the cassette
contact mat. Additionally, it provides the hydraulics with compressed air
for the membrane integrity test, for the filter emptying program, for
emptying the substituate unit, and for emptying the rinse port.
The Single-Needle unit (option) is used to aerate the cassette system
during priming and rinsing and for Single-Needle operation.

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Chapter 11: Functional description

11.7 Hydraulics (block diagram / description)

 Block diagram

LP 1135 ---------- S21, S47

----------------Sensors (SS)-------------------
CD4, CD7,
PT4, PT7,
S03, S04, S05, S06, S07, S08, S10,
S11, S16, S29, S30, S35, S36, S38,
S42, S43, S44, S45

----------------Sensors (OS)-------------------
CD5, CD9,
PT2, PT5, PT8, PT9,
S01, S09, S15, S17, S18, S19, S20,
S22, S50, S51, S53

- - - - - - - Actuators - - - - - - -
P01, P03

- - - - - - - Actuators - - - - - - -
P04, P05, P06
(+5 V and +24V_SW on LP 1141)

VG1 SS1
V40 V24 V22 V35s 24/18V
VG2 SS1
V41 V09 V25 V26 24/18V

VG1 SS2
V31 VS4s VS8s n. c. 24/18V
VG2 SS2
n. c. n. c. n. c. V42 24/18V

VG1 OS5
V21 V23 V33 V32 24/18V
VG2 OS5
V50 VS2 V51 V43 24/18V
VG1 OS4
VS1 VB1 VB2 V36 24/18V
VG2 OS4
n. c. VS3s VS5s VS6s 24/18V
VG1 OS3
V34 V30 V29s V28 24/18V
VG2 OS3
n. c. VS7s VS9s VS10s 24/18V
VG1 OS2
V11 V12 V13 V14 24/18V
VG2 OS2
V15 V16 V17 V18 24/18V

VG1 OS1
V38 V19 V03 V02 24/18V
VG2 OS1
VF2 V20 V04 VF1 24/18V

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 Chapter 11: Functional description

 Description

The power supply unit supplies the PCB LP 1141-3 with +24 V and
+18 V via PCB LP 1106. The +5 V, ±12 V voltages are generated on
PCB LP 1141-3. The +24 V_SW and the +18 V_SW are enabled via the
watchdog. PCB LP 1141-3 controls all hydraulic actuators (valves,
pumps). PCB LP 1141-3 is connected via PCB LP 1140 to the OS and
to the SS.
PCB LP 1140 contains the evaluation circuits for the sensors of the OS
and SS, e.g., temperature, conductivity, pressure, blood leak and
optical sensors. The processor power supplies and the actuator control
signals are relayed by PCB LP 1141-3 to the two processors on
PCB LP 1202-3.
PCB LP 1202-3 contains the CPU (C167), a data memory storing the
calibration data, a CAN bus driver, an analog reference voltage source,
and a serial interface. PCB LP 1202-3 requires the operating voltage
+5 V, GND, +24 V, and the Reset signal.

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504
Wasseranschluss Flush-Abfluss
H01 H02

F01 Abfluss
H19
VF2
A04

H52

V02

V19 V21

S03 F06

PT7 PT8
A05 V11 V12 V13 V14 P
V30 V23 H15
F04 Temp
CD7 V24 H42
Chapter 11: Functional description

V38 H04
H14
F05
A02 H16
H09 F42

PT4 V22 V26

VF1 V29s V42 H36
V03 Temp V31
S10
CD4 V28
V15 V16 V17 V18

H42
H03 S09
Dialyzer

ASK Shunt
PT2 H07 Bic P05 Sod P06

Temp
S04
S01 S15 P H18
S36 S05
S16
P04 CD9 S06
M

H08
P S38

CD5 A03 S11 PT9 V32 V43

P03
F08

Temp
H43 H37
V09
P01 PT5

Temp
S29
H33 H17
S30
H06

V50 V51
V33
V04 S50 S51

H50 H51 S07

H05
S35 P
V35s
V25
F07
S08 H42
V41 V40 V36
S53

VB1 VS1
F12 F11
F17
V20 V34
S20 S18
H23 VB2 VS2

S19 S17
bi ag
H20 H35
H22 H21

S22
Gelb Schwarz S21
S47
F18
VS3s VS7s
11.8 Hydraulics (flow diagram, legend, description)

VS4s VS8s

Fresenius Medical Care 6008

H54 H55

VS5s VS9s

VS6s VS10s

F14 F15

SM-EN
H29 H31

ZKV1 ZKV2

11A-2022
 Chapter 11: Functional description

Legend
Adjustable valves (A) PT9 Temperature sensor, CD OCM VS2 Deaeration valve, concentrate rinse chamber
VS3s CDS 1 shutoff valve, OS
A02 Loading pressure valve, balancing chamber
A03 Pressure limitation valve
Hydraulic sensors (S) VS4s CDS 1 shutoff valve, SS
S01 Float switch, water inlet chamber VS5s CDS 1 valve, test
A04 Pressure reducing valve, water inlet
S03 Pressure transducer, dialysate inlet port VS6s CDS 1 inlet valve
A05 Check valve, water inlet
S04 Sensor, shunt interlock dialyzer coupling inlet VS7s CDS 2 shutoff valve, OS
VS8s CDS 2 shutoff valve, SS
Filters (F) port
VS9s CDS 2 valve, test
S05 Sensor, shunt interlock open
F01 Filter, water inlet
S06 Sensor, shunt interlock dialyzer coupling out- VS10s CDS 2 inlet valve
F04 Filter stage 1
let port
F05 Filter stage 2
S07 Pressure transducer, dialysate outlet port
F06 Hydrophobic filter, pneumatic unit EBM
S08 Blood leak detector
F07 Dialysis fluid particle filter (not available in all
S09 Level sensor, secondary air separator
devices)
S10 Sensor, air separation valve
F08 Filter, UF pump
S11 UF pump, CD inlet
F11 Concentrate suction tube with filter
S15 Pressure transducer, balancing chamber
F12 Bicarbonate suction tube with filter
switching
F14 Filter CDS
S16 Pressure transducer, dry concentrate bag fill-
F15 Filter CDS2
ing
F17 Filter, bibag inlet
S17 Level sensor, concentrate rinse chamber
F18 Filter, bibag outlet
S18 Sensor, concentrate rinse chamber lock
F42 Substituate unit vent filter
S19 Level sensor, bicarbonate rinse chamber
S20 Sensor, bicarbonate rinse chamber lock
Hydraulics components (H) S21 bibag flap, bag operation position
ASK Substituate unit S22 bibag connected
H01 Adapter, water inlet S29 Sensor 1, rinse port
H02 Adapter, Flush drain S30 Sensor 2, rinse port
H03 Water inlet chamber S35 Leakage sensor, hydraulics
H04 Heat exchanger S36 UF pump, CD outlet
H05 Degassing orifice S38 UF pump, monitoring
H06 Degassing chamber S47 bibag flap, cleaning position
H07 Heater rod chamber S50 Sensor, bicarbonate air separation chamber
H08 Heater rod S51 Sensor, concentrate air separation chamber
H09 Primary air separator S53 Sensor, flap for concentrate suction tube and
H14 Balancing chamber bicarbonate suction tube
H15 Sampling valve
H16 Dialyzer coupling inlet port Hydraulic valves (V), small
H17 Dialyzer coupling outlet port
H18 Secondary air separator hydraulic valves (Vs)
H19 Adapter, drain V02 Water inlet valve
H20 Adapter, disinfectant 1 V03 Recirculation valve, cleaning
H21 Rinse chamber, concentrate V04 Override valve, degassing orifice
H22 Rinse chamber, bicarbonate V09 Fill valve, dry concentrate bag
H23 bibag connector V11 Balancing chamber valve
H29 Adapter, CDS V12 Balancing chamber valve
H31 Adapter, CDS2 V13 Balancing chamber valve
H32 Substituate unit V14 Balancing chamber valve
H33 Rinse port V15 Balancing chamber valve
H35 Adapter, disinfectant 2 V16 Balancing chamber valve
H36 Adapter, dialyzer coupling inlet port V17 Balancing chamber valve
H37 Adapter, dialyzer coupling outlet port V18 Balancing chamber valve
H42 Equipotential bonding connection V19 Drain valve
H43 Overflow adapter, inlet chamber V20 Disinfectant valve 1
H50 Air separation chamber, bicarbonate V21 Vent valve, filter stage 1
H51 Air separation chamber, concentrate V22 Retentate valve
H52 Equipotential bonding connection for drain V23 Test valve
H54 Compensation vessel, CDS, concentrate 1 V24 Dialyzer inlet valve
H55 Compensation vessel, CDS, concentrate 2 V25 Dialyzer outlet valve
V26 Bypass valve
Hydraulic pumps (P) V28 Fill valve, secondary air separator
P01 Degassing pump V29s Air separation valve
P03 Flow pump V30 Outlet valve
P04 UF pump V31 Substituate valve
P05 Bicarbonate pump V32 Rinse valve 1, H(D)F
P06 Concentrate pump V33 Rinse valve 2, H(D)F
V34 Disinfectant valve 2
Conductivity sensors (CD) V35s Negative pressure valve
V36 Rinse valve
CD4 Conductivity cell, bicarbonate
V38 Override valve, heat exchanger
CD5 Conductivity cell, bicarbonate
V40 Shutoff valve, disinfection
CD7 Conductivity cell, overall conductivity
V41 Rinse valve, disinfection
CD9 Conductivity cell, OCM
V42 Vent valve, substituate unit
V43 Rinse valve 3, substituate unit
Temperature sensors (PT) V50 Sensor, air separation valve, bicarbonate
PT2 Sensor, temperature control V51 Sensor, air separation valve, concentrate
PT4 Temperature sensor, CD bicarbonate VB1 Fill valve, bibag
PT5 Temperature sensor, CD bicarbonate VB2 Deaeration valve, bicarbonate rinse chamber
PT7 Temperature sensor, overall CD and tem- VF1 Flush valve
perature display VF2 Flush valve, drain
PT8 Sensor, temperature adjustment VS1 Rinse valve, concentrate rinse chamber

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 Description

Switching on To ensure regular rinsing of the dialysis water inlet tube, flushing is
started after switching the device on (only if the Flush device option is
present).
The flush is diverted between the heat exchanger (H04) and the Flush
valve 1 (VF1).
When the Flush valve 1 (VF1) is closed, a clocked circuit will open the
Flush valve 2 (VF2). The dialysis water (permeate) is flushed via the
dialysis water inlet tube, Flush valve 2 (VF2) and the Flush tube into the
Flush drain.

Degassing Controlled by the float switch (S01) in the water inlet chamber (H03), the
dialysis water (permeate) flows into the degassing chamber (H06). A
negative pressure is created due to the volumetric capacity of the
degassing pump (P01) and the restriction of the degassing orifice
(H05). This negative pressure is sufficient to force the air in the dialysis
water (permeate) to form air bubbles. These accumulate in the primary
air separator (H09). The air bubbles are discharged via the loading
pressure valve (A02) and the air outlet of the water inlet chamber (H03).

Heating The dialysis water (permeate) flowing through the heater rod chamber
(H07) is heated to the regular treatment temperature.

Mixing A patient-specific dialysate is prepared by proportional and volumetric

mixing of dialysis water (permeate) with different dialysis concentrates.
On its way to the balancing chamber (H14), a volume of bicarbonate
and acid concentrate which matches the proportional mixing ratio is
added (P05, P06) to the dialysis water (permeate) at the injection sites
(H12).
The acid concentrate can be drawn optionally through the concentrate
suction tube (F11) from the relevant container or from a centralized
concentrate supply (H29).
The bicarbonate concentrate can be drawn through the bicarbonate
suction tube (F12) from the relevant container or from the bibag bag
(H23).

Balancing and The hydraulics of the device are designed in such a way that the
ultrafiltration dialysate circuit is closed against the atmosphere.
This presents the basis for volumetrically controlled ultrafiltration.
The balancing chambers (H14) are operated at inverse sequences to
ensure that the volume of dialysis fluid which enters the dialyzer equals
the volume which flows back across the balancing chambers. An
impermeable elastic membrane separates the used from the fresh
dialysis fluid.
Weight reduction is solely determined by the UF pump (P04). From the
closed system, the UF pump removes a predefined volume (UF goal)
which it pumps directly into the drain, bypassing the balancing
chambers. This volume is removed from the patient's blood and is
replaced by an equal volume flowing through the dialyzer membrane.

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Dialysate circuit By way of the valves (V11, V13) fresh dialysis fluid is fed in cycles by
the balancing chambers via the filter (F04) and the dialyzer valve (V24)
to the dialyzer.
The flow pump (P03) ensures that the dialysate discharged by the
dialyzer is fed to the balancing chambers via the secondary air
separator (H18).
If the level sensor (S09) detects air, the air separation valve (V29s) is
activated. The air is discharged by the negative pressure in the
degassing path and can therefore not enter the balancing chambers.
After the balancing process the dialysate is passed via the outlet valve
(V30), the heat exchanger (H04) and the drain valve (V19) to the drain.
Correct mixing and the temperature of the fresh dialysis fluid are
monitored by the conductivity cells (CD4, CD7) and the temperature
sensor (PT7). If the values are outside the predefined limits, the device
will alert the operator and will switch to bypass mode. The dialyzer valve
(V24) closes, the bypass valve (V26) opens, so preventing the
unsuitable dialysis fluid from being fed to the dialyzer.
The pressure transducer (S07) and the blood leak detector (S08) are
further safety elements.

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 Chapter 12: Appendix

12 Appendix

12.1 Information on electromagnetic compatibility

(IEC 60601-1-2:2007)

Specifications refer to the requirements of IEC 60601-1-2:2007.

The data are valid for devices manufactured prior to 2019.

12.1.1 Minimum distances between radiation source and medical electrical equipment

Medical electrical equipment is subject to special precautions with

respect to electromagnetic compatibility (EMC).
Portable and mobile RF communications equipment is a source of
radiated interference that can affect medical electrical equipment. This
can cause device malfunctions.
For this reason, a certain minimum distance must be kept between such
radiation sources and running medical electrical equipment.

Warning
Risk for the patient as a result of a device malfunction
The use of electrical accessories and cables other than those specified
in the Instructions for Use can lead to an increase in electromagnetic
emissions or a reduction in electromagnetic immunity of the device.
 Only use accessories and cables approved by the manufacturer.

Warning
Patient hazard through electromagnetic incompatibility with other
devices
Electromagnetic interference from other devices can cause device
malfunctions.
 Do not operate the device in the immediate vicinity of other devices.
If operation in the immediate vicinity of other devices cannot be avoided:
 Monitor the device to verify that it is working properly.

Warning
Risk for the patient as a result of a device malfunction
A device malfunction can be caused by high-frequency electromagnetic
waves (radiated interference source).
 Observe the minimum required distances to radiated interference
sources.

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Chapter 12: Appendix

RF transmission technology Minimum distance from Radiated interference source

employed medical electrical equipment, (examples)
including all connecting cables
(One device/interference source
may use more than one RF
transmission technology)

GSM 3.3 m Mobile, cell phone,

(Global System for Mobile smartphone,
Communications) tablet computer

UMTS
(Universal Mobile
Telecommunications System)

LTE
(Long-Term Evolution)

DECT 1.2 m Cordless phone

(Digital Enhanced Cordless
Telecommunications)

WLAN 0.8 m Laptop/notebook,

(Wireless Local Area Network) desktop computer,
e-book reader,
WLAN repeater,
WLAN router,
WLAN access point,
WLAN print server

Bluetooth 0.3 m Wireless keyboard,

wireless mouse,
wireless speakers

Radio 0.2 m Radio remote control (except radio

remote controls by FMC)

If a source of radiated interference uses a radio frequency technology

not specified in the table, the required minimum distance to medical
electrical equipment can be obtained from the manufacturer.

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 Chapter 12: Appendix

12.1.2 Guidance and manufacturer's declaration on EMC

 Electromagnetic emissions

Guidance and manufacturer’s declaration – electromagnetic emissions

The 6008 device is intended for use in the electromagnetic environment specified below. The customer or user
of the 6008 device should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emissions CISPR 11 Group 1 The 6008 device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.

RF emissions CISPR 11 Class A The 6008 device is suitable for use in all establishments other
than domestic and those directly connected to the public low-
Harmonic emissions Class A voltage power supply network that supplies buildings used for
IEC 61000-3-2 domestic purposes.
Voltage fluctuations/flicker Compliant
emissions IEC 61000-3-3

 Electromagnetic immunity

Guidance and manufacturer's declaration – electromagnetic immunity

The 6008 device is intended for use in the electromagnetic environment specified below. The customer or the
user of the 6008 device should make sure that it is used in such an environment.

Immunity testing IEC 60601 test Compliance level Electromagnetic environment –

level guidance

Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or

discharge ±8 kV air ±8 kV air ceramic tile. If floors are covered with
IEC 61000-4-2 synthetic material, the relative humidity
should be at least 30 %.

Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that of a
transient/burst supply lines supply lines typical commercial or hospital
IEC 61000-4-4 ±1 kV for input / ±1 kV for input / environment.
output lines output lines

Surge ±1 kV line(s) to ±1 kV line(s) to Mains power quality should be that of a

IEC 61000-4-5 line(s) line(s) typical commercial or hospital
±2 kV line(s) to ±2 kV line(s) to environment.
earth earth

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Chapter 12: Appendix

Guidance and manufacturer's declaration – electromagnetic immunity

The 6008 device is intended for use in the electromagnetic environment specified below. The customer or the
user of the 6008 device should make sure that it is used in such an environment.

Immunity testing IEC 60601 test Compliance level Electromagnetic environment –

level guidance

Voltage dips, short < 5 % UT (> 95 % < 5 % UT (> 95 % In the event of power supply interruptions,
interruptions and dip in UT) for 0.5 dip in UT) for 0.5 the rechargeable battery of the 6008
voltage variations cycle cycle device temporarily takes over the supply
on power supply for parts of the system without delay.
input lines 40 % UT (60 % dip 40 % UT (60 % dip
in UT) for 5 cycles in UT) for 5 cycles Mains power quality should be that of a
IEC 61000-4-11
typical commercial or hospital
70 % UT (30 % dip 70 % UT (30 % dip environment.
in UT) for 25 cycles in UT) for 25 cycles

< 5 % UT (> 95 % < 5 % UT (> 95 %

dip in UT) for 5 s dip in UT) for 5 s

Power frequency 3 A/m 3 A/m Power frequency magnetic fields should

(50/60 Hz) magnetic be at levels characteristic of a typical
field IEC 61000-4-8 location in a typical commercial or hospital
environment.

Note: UT is the AC mains voltage prior to application of the test level.

512 Fresenius Medical Care 6008 SM-EN 11A-2022

 Chapter 12: Appendix

Guidance and manufacturer's declaration – electromagnetic immunity

The 6008 device is intended for use in the electromagnetic environment specified below. The customer or the
user of the 6008 device should make sure that it is used in such an environment.

Immunity testing IEC 60601 test Compliance level Electromagnetic environment –

level guidance

Portable and mobile RF communications

equipment should be used no closer to
any part of the 6008 device, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.

Recommended separation distance:

Conducted RF 3 Vrms 3 Vrms d = 1.17 √P

IEC 61000-4-6 150 kHz to 80 MHz for 150 kHz to < 80 MHz

Radiated RF 3 V/m 3 V/m d = 1.17 √P

IEC 61000-4-3 80 MHz to 2.5 GHz for 80 MHz to < 800 MHz
d = 2.33 √P
for 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveya, should be less than the
compliance level in each frequency
rangeb.
Interference may occur in the
vicinity of equipment marked with
the following symbol.

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
6008 device is used exceeds the applicable RF compliance level above, the 6008 device should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the 6008 device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Chapter 12: Appendix

 Recommended separation distances between portable and mobile RF communications

equipment and the 6008 device

Recommended separation distances between portable and mobile RF telecommunications equipment

and the 6008 device.

The 6008 device is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the 6008 device can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the 6008 device as recommended below, according to the maximum output power of the communications
equipment.

Rated maximum Separation distance according to frequency of transmitter m

output power of
transmitter 150 kHz to < 80 MHz 80 MHz to < 800 MHz 800 MHz to 2.5 GHz

W d = 1.17 √P d = 1.17 √P d = 2.34 √P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.2 1.2 2.3

10 3.7 3.7 7.4

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

514 Fresenius Medical Care 6008 SM-EN 11A-2022