Rev L
Rev L
2008K
HEMODIALYSIS
4 5 6
7 8 9 0
SYSTEM
PREVENTIVE
MAINTENANCE
PROCEDURES
Manufactured by:
Fresenius USA, Inc.
4040 Nelson Avenue
Concord, CA 94520
PREVENTIVE MAINTENANCE
PROCEDURES
Part Number 507297 Rev. L
INCLUDING
PREVENTIVE MAINTENANCE CHECKLISTS
QUARTERLY/1000 HOUR AND ANNUAL/4000 HOUR
http://www.fmcna.com
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2008K Preventive Maintenance Procedures
P/N 507297 Rev. L
2008K Preventive Maintenance Procedures
This document contains proprietary information of Fresenius USA, Inc. d/b/a Fresenius
Medical Care North America and its affiliates (“Fresenius Medical Care”). The contents of
this document may not be disclosed to third parties, copied, or duplicated in any form, in
whole or in part, without the prior written permission of Fresenius Medical Care.
Fresenius Medical Care, the triangle logo, 2008 and DIASAFE are trademarks of Fresenius
Medical Care Holdings, Inc., or its affiliated companies. All other trademarks are the
property of their respective owners.
Caution: US Federal law restricts this device to sale only by or on the order of a physician.
Frequency, duration, and parameters of treatment are to be determined by the prescribing
physician.
Installation, maintenance, calibration and other technical information may be found in the
2008K Technician’s Manual, P/N 490049.
Contact Fresenius Medical Care Technical Support for applicable Field Service Bulletins.
The spare parts manual for the model 2008K and other information may be found on our web
site at www.fmcna.com
Indications for Use: The 2008K hemodialysis machine is indicated for acute and chronic
dialysis therapy.
Conventions
Symbol Description
Warning! A warning is a statement that identifies conditions or
actions that could result in personal injury or loss of life.
Warnings found in this manual outside of this section are
designated with the warning symbol.
Shock Hazard: A shock hazard warning refers to a risk of a
possibly severe electrical shock due to improper use or handling
of the equipment.
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2008K Preventive Maintenance Procedures
P/N 507297 Rev. L
PREVENTIVE MAINTENANCE PROCEDURES
TABLE OF CONTENTS
1.0 INTRODUCTION ............................................................................................................................................ 1
1.1 TEST EQUIPMENT AND SUPPLIES NEEDED .......................................................................... 1
1.2 OPERATING MODES ................................................................................................................ 3
1.3 FRONT PANEL CONTROLS ...................................................................................................... 4
1.4 MEASURING FLUID VOLUMES ................................................................................................ 6
2.0 QUARTERLY (1000 HOUR) PREVENTIVE MAINTENANCE ....................................................................... 7
2.1 FILTERS AND O-RINGS ............................................................................................................ 9
2.2 PRE-UF PUMP FILTER ............................................................................................................ 10
2.3 DIASAFE FILTER (IF APPLICABLE) ...................................................................................... 10
2.4 UF PUMP CHECK VALVES ..................................................................................................... 10
2.5 HIGH VOLTAGE AC CONNECTIONS ...................................................................................... 11
2.6 UF PUMP ................................................................................................................................. 12
2.7 CONDUCTIVITY ...................................................................................................................... 12
2.8 TEMPERATURE ...................................................................................................................... 13
2.9 LEVEL DETECTOR .................................................................................................................. 14
2.10 ALARM OPERATION AND PRESSURE HOLDING TESTS ..................................................... 18
2.11 VERIFY PH .............................................................................................................................. 20
2.12 POWER FAILURE ALARM ....................................................................................................... 20
2.13 BLOOD PUMP ROTOR INSPECTION ..................................................................................... 21
2.14 FINAL CHECKS ....................................................................................................................... 23
3.0 ANNUAL (4000 HOUR) PREVENTIVE MAINTENANCE ............................................................................ 24
3.1 FILTERS AND O-RINGS .......................................................................................................... 24
3.2 PRE-UF PUMP FILTER ............................................................................................................ 24
3.3 UF PUMP CHECK VALVES ..................................................................................................... 24
3.4 DEAERATION RESTRICTOR .................................................................................................. 25
3.5 DIASAFE FILTER (IF APPLICABLE) ...................................................................................... 25
3.6 DIAPHRAGM PUMPS .............................................................................................................. 25
3.7 HEATER ELEMENT ................................................................................................................. 26
3.8 HIGH VOLTAGE AC CONNECTIONS ...................................................................................... 26
3.9 DEAERATION MOTOR BRUSHES .......................................................................................... 27
3.10 INLET WATER PRESSURE REGULATOR .............................................................................. 28
3.11 ONLINE CLEARANCE TEST (IF APPLICABLE)....................................................................... 29
3.12 DEAERATION AND LOADING PRESSURE ............................................................................ 32
3.13 FLOW RELIEF PRESSURE ..................................................................................................... 33
3.14 CONCENTRATE AND BICARB PUMPS .................................................................................. 34
3.15 UF PUMP ................................................................................................................................. 34
3.16 CONDUCTIVITY ...................................................................................................................... 34
3.17 TEMPERATURE ...................................................................................................................... 34
3.18 VOLT HI LO DETECT ............................................................................................................... 34
3.19 BLOOD LEAK AND DIMNESS ................................................................................................. 35
3.20 ARTERIAL, VENOUS AND TRANSMEMBRANE PRESSURE ................................................. 36
3.21 DIALYSATE FLOW .................................................................................................................. 39
3.22 HEPARIN PUMP ...................................................................................................................... 39
3.23 BLOOD PUMP .......................................................................................................................... 42
3.24 LEVEL DETECTOR .................................................................................................................. 44
3.25 ALARM AND PRESSURE HOLDING TESTS ........................................................................... 44
3.26 VERIFY PH .............................................................................................................................. 44
3.27 RINSE CHECKS ....................................................................................................................... 45
3.28 POWER FAILURE ALARM AND BATTERY REPLACEMENT .................................................. 46
3.29 BLOOD PRESSURE MODULE ................................................................................................ 47
3.30 FINAL CHECKS ....................................................................................................................... 50
4.0 REBUILDING THE DIAPHRAGM PUMPS .................................................................................................. 51
4.1 REBUILDING THE ULTRAFILTRATION PUMP ....................................................................... 51
4.2 REBUILDING THE CONCENTRATE AND BICARBONATE PUMPS ....................................... 54
4.3 TESTING CONCENTRATE AND BICARBONATE PUMPS ...................................................... 56
PREVENTIVE MAINTENANCE CHECKLIST QUARTERLY/1000 HOUR ........................................................... 61
PREVENTIVE MAINTENANCE CHECKLIST ANNUAL/4000 HOUR .................................................................. 63
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2008K Preventive Maintenance Procedures
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General Warnings
Warning! Never perform maintenance when a patient is
connected to the machine. If possible, remove the machine from
the treatment area when it is being serviced. Label the machine to
ensure it is not accidentally returned to clinical use before the
service work is completed. Always fully test the machine when
maintenance is completed. Confirm dialysate conductivity and pH
level before returning the machine to clinical use.
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1.0 INTRODUCTION
Preventive Maintenance for the 2008K Hemodialysis System is simple and
straightforward. Maintenance is performed in only two intervals: Quarterly or after
1000 hours of operation, and annually or after 4000 hours of operation. The
maintenance procedures have been devised to require a minimum of time while
ensuring that the machine is maintained in optimum operating condition.
Included in the Preventive Maintenance procedures are tests to verify normal machine
operation. Should the machine fail to pass any of these tests, repair or re-calibrate as
needed, then repeat the tests until the specifications are met before returning the
machine to service.
Checklists are provided in the back of this manual to record the work done. Make
copies of these checklists as needed. Your initials on the checklist certifies that each
procedure has been completed and that the machine is performing according to the
specifications given.
Warning! Test equipment used must be maintained and/or calibrated per the
test equipment manufacturer’s requirements. In particular, the dialysate meter
must meet the specifications listed below. Refer to the test equipment's'
operator's manual, or contact the manufacturer for calibration and maintenance
requirements. Failure to properly maintain and calibrate test equipment could
lead to improper calibration and/or failure of the device to meet its
specifications.
Warning! Disinfect the machine internally and externally and check all
pressure transducer protectors for contamination before working on the
machine.
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2008K Preventive Maintenance Procedures
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• 2008K Calibration Procedures (part number 507296).
• Test Kit (part number 150034), which contains two pressure gauges with
fittings and hoses for measuring loading pressure and deaeration pressure.
• Dialysate meter to measure dialysate pressure, temperature and conductivity at
the ends of the dialysate lines. The meter must be capable of making pressure
measurements from -250mmHg to +400mmHg with an accuracy of at least
±3mmHg. The temperature function of this meter must be accurate within
0.2°C from 20°C to 45°C and must be capable of measuring dialysate
temperatures up to 85°C with an accuracy of at least ±4.0°C. The conductivity
function of this meter must be accurate to within 0.1mS over a range of 12mS to
17mS at a temperature of 25°C.
• Stopwatch with a resolution to 0.01 second and an accuracy of 0.01% or better.
• Buret, 25ml capacity with 0.1ml graduations (part number 290104).
• Graduated cylinder: 1000ml capacity with a tolerance of 5.0ml at 1000ml or
better.
• Syringe, 60cc capacity. Tolerance is not important; the syringe is not used for
volume measurements.
• Tubing, 24” long (part number 545325-10). Use on the tip of the Buret.
• Resistor Plug Set for OLC Testing (part number 190168).
The following equipment is also required to test the blood pressure module:
• Dummy Cuff (part number 370090). The Dummy Cuff contains two air
chambers with calibrated volumes.
• Mercury manometer or equivalent pressure meter accurate to within 1mmHg at
pressures up to 330mmHg.
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1.2 OPERATING MODES
The following preventive maintenance procedures contain instructions to place the
2008K into Dialysis Mode and Service Mode.
To place the machine in Service Mode, turn the machine power On and wait for the
message Press CONFIRM for Service Mode to appear. Once it appears, press the
[CONFIRM] key and the message will change to Machine in Service Mode. After
the System Initializing process is complete, the machine will be in Service Mode.
If the [CONFIRM] key is not pressed when the Press CONFIRM for Service Mode
message is on the screen, the screen will change and the message Machine in
Dialysis Mode will appear. After the System Initializing process is complete, the
machine will be in Dialysis Mode.
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1.3 FRONT PANEL CONTROLS
The front panel consists of two areas, the touch screen and the control panel. The
touch screen is the area under the glass in the center of the front panel. The control
panel surrounds the touch screen and it contains the membrane keys.
Touch Screen
Control Panel
In this example, the [CONFIRM] key on the control panel should be pressed.
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Touch Screen Operation
The touch screen is designed to display information and is used to enter data. To
select a button during a procedure, locate the button on the screen. Select a
parameter for which data will be entered using the keys below the screen.
Depending on the type of button, the screen will change. Data boxes are also
displayed on the touch screen. The following describes the type of buttons and data
boxes that will be encountered during the preventive maintenance process.
Data Button
A yellow data button is used to enter a measured volume or
value. When the yellow area of the data button is touched,
it will change to a darker yellow. The data can be changed
using the [▲] and [▼] keys or the value can be entered using
the number keys both on the control panel. Once the data is
entered, press the [CONFIRM] key and the data button
changes back to light yellow. The [Escape] key can be
pressed when the data button is dark yellow to abort the data
entry and return it to light yellow. The entered data does not
get stored until the [CONFIRM] key is pressed.
Some data buttons will change the screen and the data entry
will be performed on the new screen.
A gray data button means the button is not active and
touching it will have no effect.
Screen Button
Blue rectangles on the touch screen are screen buttons. By
touching the blue area of the screen button the display will
either change to another screen or the selection of an option
will change. A screen button is not active if it is gray.
Data Box
This type of box shows selected data or data the machine is
measuring. During the preventive maintenance process this
type of box is used to verify a value or selection.
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1.4 MEASURING FLUID VOLUMES
Several of the following procedures require measuring fluid volumes using
graduated cylinders and laboratory burets. When making these measurements do the
following:
• Make certain the container is clean and dry before collecting the fluid to be
measured. Two drops of fluid are approximately 0.1ml, which is enough to
affect the accuracy of critical measurements.
• Surface tension causes the fluid to curve into a meniscus (See Figure 2).
Measure the volume at the bottom of the meniscus curve as shown.
BOTTOM OF
MENISCUS
CURVE
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2.0 QUARTERLY (1000 HOUR) PREVENTIVE MAINTENANCE
Perform the following Preventive Maintenance procedures every 3 months or
1000 hours of machine operation, whichever comes first.
While performing the following procedures, check the floor of the hydraulic unit and
all surfaces for moisture that might indicate a leak. Locate and correct any leaks
detected. Clean the floor of the hydraulic unit so that future leaks will be readily
apparent. Also, check all electrical connectors that can be reached to be sure they
are fully seated and there is no strain on the electrical cables.
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9-VOLT BATTERY
BLOOD PRESSURE
DIALYSATE LINE MODULE
CONN. O-RINGS
P/N 579097
STRAIN
RELIEF
DIALYSATE
INLINE FILTER HEATER
P/N 650113 CONNECTIONS
BICARBONATE PUMP
HEATER ELEMENT
INLET PRESSURE P/N 250169
REGULATOR
DEAERATION PUMP
FLOW PUMP INLET
OUTLET
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2.1 FILTERS AND O-RINGS
Clean filters and replace O-rings as follows. Replace any filters that appear
damaged or corroded.
1. Inlet Water Filter in the inlet connector of the water supply (See Figure 3,
pg. 8).
Warning! After cleaning or replacing the inlet filter screen, disinfect the
water inlet line as described in the Operator’s manual and in accordance with
your Unit Policy.
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2.2 PRE-UF PUMP FILTER
Inspect the Pre-UF Pump filter for leaks or distortion. Replace the Pre-UF Pump Filter
if leakage or distortion is found.
Note: If the machine is equipped with a DIASAFE filter, replace its quick
connector O-rings (part number 579097) when replacing the filter.
Inspect the UF Pump Output check valves (one at the UF pump and the other
downstream at the UF Sample Port). Replace any that show signs of wear, damage
or leaking.
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2.5 HIGH VOLTAGE AC CONNECTIONS
1. Remove power from the machine then check and tighten the 8-pin heater
connections next to the distribution board (See Figure 3, pg. 8). Check
heater block AC connections for signs of arcing or melting.
2. If applicable, inspect the power plug for loose or frayed wires. Ensure the
strain relief is securely fastened.
3. Inspect the entire length of the power cord (from plug to strain relief) for
nicks or cuts in the insulation and replace if necessary (part number
150425).
4. Confirm that the strain relief is tightly secured to the power supply chassis.
5. At the strain relief, locate the black, white and green wires from the power
cord (inside the power supply chassis). Follow the black and white wires to
the main power switch. Attached to the main power switch are four (4)
wires (2 black and 2 white). Look for loose connections, cracked insulation,
and signs of overheating, such as discolored or melted insulation. Replace
wires with power supply wire kit (part number 190411).
6. Inspect the main power switch and verify that its operation is smooth (no
grinding or sticky operation) and that the wires are not crossed.
Shock Hazard: Do not operate the machine if the resistance is greater than
0.2 ohm. A shock hazard to operators and patients could exist.
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8. Record the measured value on either the Quarterly Preventive Maintenance
Checklist or the Annual/4000 Hour Preventive Maintenance Checklist
depending upon which is being performed.
2.6 UF PUMP
Calibrate the UF Pump Volume (Refer to the 2008K Calibration Procedures –part
number 507296.)
Record the measured value on the Six (6) Month Preventive Maintenance Checklist.
2.7 CONDUCTIVITY
Verify that the dialysate conductivity measured by the internal cell in the machine
agrees with an external conductivity meter within 0.1mS/cm as follows:
2. With the machine in Dialysis Mode and flow ON, compare the value shown
on the external conductivity meter with the conductivity shown on the
Display screen. They must be within 0.1mS/cm of each other.
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2.8 TEMPERATURE
Verify that the actual dialysate temperature measured by an external temperature
meter agrees with the display screen within 0.3°C at 37°C and 39°C as follows:
1. Connect the dialysate lines to an external temperature meter.
2. Place the machine in Dialysis Mode with concentrate in the system. Clear
any alarms.
3. Select the Temperature button. The button label will change to Temp.
Setting. The value now displayed on this button is the temperature set
point. Adjust the temperature set point to exactly 37.0 then press the
[CONFIRM] key. The button will change back and now reads the actual
temperature of the dialysate again. Wait until this value stabilizes. It will
settle very close to the value set, depending upon inlet water temperature
and other conditions.
6. Repeat steps 3 and 4 with the temperature set to 39.0°C. Verify that the
actual temperature reported on the front panel display screen and the
external temperature meter is within 0.3°C of each other after the
temperatures stabilize again.
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2.9 LEVEL DETECTOR
Caution: In the following steps, the level detector must be removed from the
machine cabinet. Before returning it to the cabinet, wipe the lower edge of the
module and the level detector cabinet opening to remove any residual
disinfecting agent. When installing the module screws do not use a power
screwdriver.
ALARM TEST
1. Perform the Level Detector calibration per the procedure outlined in the
2008K Calibration Procedures (part number 507296).
2. Place the machine in Dialysis Mode and turn the blood pump ON. Insert a
water filled venous chamber into the level detector and clear all alarms.
3. Position the Level Detector so you can watch the Channel 1 and Channel 2
LED's on the circuit board (See Figure 6 on page 16).
4. While watching the Channel 1 and Channel 2 LED's, remove the venous
chamber to create a blood alarm and close the occlusion clamp. Verify that
the Channel 1 LED lights first followed quickly by Channel 2.
OCCLUSION CLAMP TEST
1. Place a venous line into the closed occlusion clamp. Do not connect this
line to the venous chamber in the level detector.
2. Place the lower end of the venous line below the occlusion clamp in a
container of water positioned so that air escaping from the end of the line is
easily seen.
3. Connect a syringe and a pressure gauge to the venous line above the
occlusion clamp.
4. With the syringe, apply a pressure of at least 30psi (1550mmHg) to the
venous line while watching the end of the venous line in the water.
5. Verify that no air escapes from the venous line, indicating that the clamp is
fully occluding the line.
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RELAY CONTACT TEST
A relay prevents the level up and level down membrane keys on the face of the
level detector to function if they are pressed at the same time.
Various module configurations are available. Use the following information to
select the correct method to use to check the relay contacts:
• Use Method 1 if LP450 has LED’s D6 & D19 (See Figure 5)
• Use Method 2 if LP450 does not have relay test LED’s then locate a separate
relay board LP1026 with test LED’s D3 & D4 (See Figure 5).
• Use Method 3 if LP1026 is present and does not have LED’s D3 & D4
(See Figure 6).
Method 1:
1. With the machine in Dialysis Mode and the blood pump turned ON, insert a
water filled venous chamber into the level detector and clear all alarms
2. Locate the relay test LED’s D6 and D19 on the LP450 board.
3. To test the LED’s, press the level down switch on the face of the level
detector and verify that both LED’s D6 and D19 light. The on-board air
pump will also run. If both LED’s light, proceed to step 4.
Note: If either LED doesn’t light during the LED test (step 3), then the
results of the Relay Contact Test (step 4) are invalid. In this case use the
appropriate step below instead of step 4:
While in alarm condition (clamp closed), attach the ground lead of a voltmeter
to TP3 (ground) on the LP450 board. Measure the voltage on the solder side
of pins 1 and 2 of X153 on the LP450 board. Verify that both pins are 0 volts.
If voltage is present, the relay contacts are bad.
4. To test the relay contacts, remove the venous chamber to create a blood
alarm and verify that both LED’s D6 and D19 do not light when the level
down switch is pressed. If either LED lights, the relay contacts are bad.
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RELAY CONTACT TEST RELAY CONTACT
LED’S D19 & D6 ON LP450 TEST LED’S D3 & D4
BOARD WHEN LP1026 IS ON LP1026 BOARD.
NOT PRESENT
X153 ON LP450
CHANNEL 1 LED
LIGHTS FIRST
CHANNEL 2 LED
LIGHTS SECOND
TP3 (GROUND)
X4 ON RELAY
BOARD LP1026
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Method 2:
1. With the machine in Dialysis Mode and the blood pump turned ON, insert a
water filled venous chamber into the level detector and clear all alarms.
2. Locate the relay test LED’s D3 and D4 on the LP1026 board.
3. To test the LED’s, press the level down switch on the face of the level
detector and verify that both LED’s D3 and D4 light. The on-board air
pump will also run. If both LED’s light, proceed to step 4.
Note: If either LED doesn’t light during the LED test (step 3), then the
results of the Relay Contact Test (step 4) would be invalid. In this case use
Method 3 instead.
4. To test the relay contacts, remove the venous chamber to create a blood
alarm and verify that both LED’s D3 and D4 do not light when the level
down switch is pressed. If either LED lights, the relay contacts are bad
Method 3:
1. With the machine in Dialysis Mode and the blood pump turned ON, insert a
water filled venous chamber into the level detector and clear all alarms
2. Locate the solder side of X4 on the LP1026 (or X153 on the LP450).
3. Attach the ground lead of a voltmeter to TP3 (ground) on the LP450 board.
4. Test for 24 volts at X4 (X153) by pressing the level down switch on the face
of the level detector and verify that both pins 1 and 2 on the solder side of
X4 (X153) are 24 volts.
5. To test the relay contacts, remove the venous chamber to create a blood
alarm and measure the voltage on the solder side of pins 1 and 2 of X4
(X153). Verify that both pins are 0 volts. If voltage is present, the relay
contacts are bad.
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2.10 ALARM OPERATION AND PRESSURE HOLDING TESTS
Verify the automatic alarms produce the responses shown in Table 1 and the
machine passes the automatic pressure holding test as follows:
1. Place the dialysate lines in the shunt and close the door.
Warning! The use of a “test drip chamber” or “dummy drip chamber” must
never be used on the treatment floor. It must only be used in a controlled
technical environment.
2. Place a venous chamber filled with water in the holder on the level detector
module.
3. Place the machine in Dialyze mode and start the blood pump. Clear all
blood and water alarms.
4. Select the Test & Options button. On this screen press the Both Tests
button. Press the [CONFIRM] key to start.
5. Observe the machine stepping through the following alarm tests and ensure
that each alarm produces all of the responses shown in Table 1.
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2008K Preventive Maintenance Procedures
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Table 1. Alarm Tests.
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6. When the tests shown in Table 1 are complete, the machine conducts a
pressure holding test. When the test ends verify that the display screen
reports TEST COMPLETE, indicating that all the tests were passed
successfully. Press the [RESET] key.
7. Test the UF pump integrity as follows:
• Pull the hydraulics out and remove the output tube from the UF pump.
• Install a 24” tube (part number 545325-10) to the empty output port.
Route this tubing out the back of the machine so that it will not be
kinked or pinched when the hydraulics is closed. Close the hydraulics
and place the other end of tube into a collection container.
• Conduct steps 1-6 again.
- If the pressure holding test fails, refer to Section 4.1.
- If the pressure holding test passes, disconnect the 24” tube and
reconnect the original output tube to the UF pump.
• Place a piece of opaque paper inside the housing of the optical detector
to simulate a line containing blood. Close the door of the optical
detector.
• Open the shunt door. Verify that the machine responds with an
audible alarm. Press the [Mute] key and verify that the Mute lamp
lights, and the audible tone stops.
2.11 VERIFY pH
1. Place the machine into dialysis mode and allow it 10 minutes to stabilize.
2. Use a pH test strip (part number 335130-01 or equivalent) to verify the
dialysate fluid is between the ANSI/AAMI RD52 standard of 6.9 and 7.6.
3. Record the measured value on the Quarterly Preventive Maintenance
Checklist.
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2.13 BLOOD PUMP ROTOR INSPECTION
Clean and inspect the arterial blood pump rotor assembly as follows:
1. Remove the blood pump rotor by opening the door, pulling out the crank
lever and turning the rotor 90 degrees.
2. Clean the rollers with a cloth dampened only with water.
3. With the crank lever pulled out, locate and lubricate the crank lever retainer
ball. See Figure 7 for assistance. If the crank lever is hard to pull out,
replace the crank lever retainer assembly (part number 564301).
4. Clean the inside of the blood pump housing with the damp cloth.
Compressed air may be used if it is available.
5. Locate the four (4) tubing guides. See Figure 7 for assistance. If any of the
four (4) tubing guides are missing, the rotor assembly needs to be replaced
(part number M30990).
Tubing Guides
Tubing Guide
Tubing Guide
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Note: On newer blood pump rotors (M30990) the plastic sleeves are not
replaceable. If sleeves are damaged, replace the rotor assembly.
6. On each of the tubing guides there is a plastic sleeve that should rotate
smoothly. Inspect each plastic sleeve for smooth operation. If any of the
plastic sleeves are missing, damaged, or do not rotate smoothly, replace with
a new plastic sleeve. See Figure 8 for an exploded view and part numbers.
Plastic Sleeve
P/N 641256
Tubing Guide
(Exploded View)
Figure 8. Tubing Guide (Exploded View)
7. Without removing the plastic sleeve, inspect the solid guide post on all four
(4) tubing guides. The solid guide post should not be loose or bent. If any
of the solid guide posts are loose or bent, the rotor assembly needs to be
replaced. (part number M30990).
Note: The plastic sleeve will make it feel like the solid guide post is loose.
When inspecting, pay close attention to the movement of the metal shaft.
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2.14 FINAL CHECKS
Before returning the machine to clinical use after successful completion of all of the
Preventive Maintenance procedures listed above, complete the following:
• Verify that the machine label with serial number is in place, usually on the back
of the cabinet near the Monitor Control Unit or above the quick connectors of the
open shunt door assembly. Record this serial number on the Preventive
Maintenance Checklist form.
• Verify that no dialysate spills or leaks are visible in the hydraulics or on the
bottom of the cabinet. Clean and dry any spills found and correct the source.
• Verify that all cables are properly routed to prevent pinching or chaffing.
• Verify that all covers are replaced and that all cover screws and mounting
hardware has been replaced.
Caution: Reliable operation of the machine requires that all screws and
covers be properly installed. Ensure that all screws and covers are in place
before returning the machine to clinical use.
• Clean the exterior surfaces of the machine and remove all traces of dirt, oil or
other contaminants.
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3.0 ANNUAL (4000 HOUR) PREVENTIVE MAINTENANCE
Perform the following Preventive Maintenance procedures every 12 months or
4000 hours of machine operation, whichever comes first. Perform the procedures in
the order given below to complete the Annual Preventive.
Make copies of the Annual Preventive Maintenance Checklist provided at the back of
this manual and use them to record the maintenance done.
Caution: Ensure each check valve is oriented correctly to allow fluid flow in
the proper direction.
Replace the UF Pump Output check valves. There are two check valves at the UF
pump output. One is at the UF pump itself. The other is downstream at the UF
Sample Port.
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2008K Preventive Maintenance Procedures
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3.4 DEAERATION RESTRICTOR
With the machine off, replace the deaeration restrictor O-rings by clamping the
hydroblock vent tube and removing the deaeration restrictor from the hydroblock (See
Figure 3, pg. 8). Replace the two O-rings on the deaeration restrictor (part number
F40007100 or 579070). Clean any debris that may be present in the angled hole at the
tip of the deaeration restrictor. Reinstall deaeration restrictor.
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3.7 HEATER ELEMENT
1. Remove the rear access panels and distribution board cover so that the wires of
the heater are accessible.
Note: If the heater element is replaced, replace the heater O-ring as well
(part number F40007103 or 579075).
2. Remove the heater element from the hydroblock on the machine (See Figure 3,
pg. 8). Inspect the heater element for signs of corrosion. If corrosion exists,
replace the heater element.
3. Attach one lead of the voltmeter to the ground (yellow / green wire) and the
other lead to the brown or blue wire. Measure the resistance. Resistance should
be “ OL “ or greater than 19.9 meg-ohms. If this is not the case, replace the
heater element.
4. After completing this check, reinstall the heater element and O-ring.
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3.9 DEAERATION MOTOR BRUSHES
Replace the deaeration motor brushes every 8000 hours using the following steps:
1. Remove the complete deaeration motor/pump assembly from the machine.
2. Using a marker, make marks on the motor housing and motor cap as
illustrated below. These marks will ensure the correct alignment when
reassembling the motor case.
Use Marker
Use marker to make hatch
marks
marks to ensure
to ensure proper
proper
reassembling
reassembling of motor
of motor
Motor Cap
3. Using a T-25 Torx screwdriver, remove the two screws holding the motor
cap to the motor housing.
4. Remove the motor cap to gain access to the motor brushes. Replace the
motor brushes.
5. Reassemble the motor, aligning the marks.
6. While holding the pieces together, install and tighten the two T-25 screws.
Note: If the motor case and motor cap are not installed using the marks, the
motor will run in reverse and flow errors will result.
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3.10 INLET WATER PRESSURE REGULATOR
Verify that the regulator provides the proper water pressure as follows:
Caution: Use tie wraps or tubing clamps to secure the connections. The
water pressure may be sufficient to blow the lines off the fittings if they are not
secured.
Note: Readings below 8psi at the lowest level indicates inadequate inlet
water flow into the machine. This may be caused by a dirty inlet filter screen
or problems with the treated water supply.
12. If the Inlet Pressure Regulator passes the internal leakage test, turn the
machine OFF, turn OFF the water supply, remove the pressure gauge and
reconnect the tubing using clamps to prevent leaks.
13. Turn the treated water supply source ON, turn the machine ON and select
Dialysis Mode. Start dialysate flow and inspect all hoses and connections.
Ensure that there are no leaks.
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3.11 ONLINE CLEARANCE TEST (IF APPLICABLE)
If the machine is equipped with Online Clearance (OLC), conduct the following test:
OLC Self-Test
1. With stable temperature and conductivity, start an OLC Self-Test by
pressing the OLC Self-Test screen button on the Kt/V screen.
Note: Switch to the debug screens by pressing and holding the [▲] and [▼]
keys at the same time for approximately 1 sec. The main display will change
indicating that the machine is in debug mode.
2. When the OLC Self-Test is complete, go to debug screen #5 and confirm that
0 Test (0TST prior to functional software version 3.02) is in the range ±20.
Note: If 0 Test (0TST) is out of range, the OLC Self-Test will fail. If this
happens, conduct temperature (PRE & POST) and conductivity calibrations,
then conduct OLC Self-Test again.
Note: On functional software prior to version 3.02, an OLC Self Test will
start automatically as soon as temperature and conductivity are stable. Once
the test starts cancel it by opening the shunt door. The cancel message will be
hidden by the Shunt Door Open banner. Close the shunt door and confirm
that OLC Self Test banner is gone.
Note: Due to the resistor placement inside the OLC test plugs, the orientation
of the plug when inserted onto the distribution board is irrelevant.
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2008K Preventive Maintenance Procedures
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4. Switch to the debug screens by pressing and holding the [▲] and [▼] keys at
the same time for approximately 1 sec. The main display will change
indicating that the machine is in debug mode.
5. Use the [▲] and [▼] keys to go to debug screen #5.
6. On debug screen #5, locate TPRE and observe its value for 1 minute. During
this time, record the highest and lowest values observed in the table below.
TPRE - =
7. Calculate the difference between the highest and lowest TPRE value and
record it in the table above.
8. Verify that the difference for TPRE < 2. If the difference for TPRE > 2, then
possible causes are sensor board, motor noise, or -12V problems.
9. Again, on debug screen #5, locate CPRE and observe its value for 1 minute.
During this time, record the highest and lowest values observed in the table
below.
CPRE - =
10. Calculate the difference between the highest and lowest CPRE value and
record it in the table above.
11. Verify that the difference for CPRE < 8. If the difference for CPRE > 8,
then possible causes are sensor board, motor noise, or -12V problems.
12. Remove the 6.04KΩ and 274Ω plug from the distribution board and
replace the original connectors.
13. Remove X44 (NTC-POST) and X13 (COND-POS) from the distribution
board.
14. Using the Resistor Plug Set for OLC Testing (part number 190168),
plug the 6.04KΩ plug into X44 (NTC-POST) and the 274Ω plug into
X13 (COND-POS) on the distribution board.
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15. On debug screen #5, locate TPOS and observe its value for 1 minute.
During this time, record the highest and lowest values observed in the
table below.
TPOS - =
16. Calculate the difference between the highest and lowest TPOS value and
record it in the table above.
17. Verify that the difference for TPOS < 2. If the difference for TPOS > 2, then
possible causes are sensor board, motor noise, or -12V problems.
18. Again, on debug screen #5, locate CPOS and observe its value for 1 minute.
During this time, record the highest and lowest values observed in the table
below.
CPOS - =
19. Calculate the difference between the highest and lowest CPOS value and
record it in the table above.
20. Verify that the difference for CPOS < 8. If the difference for CPOS > 8,
then possible causes are sensor board, motor noise, or -12V problems.
Note: In the following step, conduct the test for the dialysate flow ON to
OFF transition.
21. With the 6.04KΩ plug on X44 (NTC-POST) and the 274Ω plug on X13
(COND-POS) of the distribution board, verify that CPOS does not change
more than 10 increments when the dialysate flow is turned OFF. (Note:
Conduct this test for the dialysate flow ON to OFF transition.)
22. Remove the 6.04KΩ and 274Ω plug from the distribution board and
replace the original connectors.
23. With stable temperature and conductivity, start an OLC Self Test by
pressing the OLC Self-Test screen button on the Kt/V screen.
24. When the OLC Self Test is complete, go to debug screen #5 and confirm that
0 Test (0TST prior to functional software version 3.02) is in the range ±20.
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3.12 DEAERATION AND LOADING PRESSURE
Verify that the deaeration pressure is between –24 and -25 inHg and the loading
pressure is between 18 and 20psi (between 23 and 25psi if a DIASAFE filter
system is installed) as follows:
1. With dialysate flow OFF, install a pressure gauge with a T-fitting to monitor the
pressure on the inlet (suction) side of the deaeration pump (See Figure 3, pg. 8).
2. Connect a pressure gauge equipped with a yellow connector into the red
ACETATE/ACID port.
3. In Dialysis Mode, turn dialysate flow ON and verify that the pressure gauge
on the deaeration pump indicates between -24 and -25 inHg. The needle
will be vibrating somewhat. Verify that it does not go higher than -24 inHg
or lower than -25 Hg. Verify that the pressure gauge in the
ACETATE/ACID port indicates between 18 and 20psi (between 23 and
25psi if a DIASAFE filter system is installed).
4. Record the measured values on the Annual/4000 Hour Preventive
Maintenance Checklist.
Note: When the machine is at a different elevation above sea level, it may be
difficult or impossible to achieve -24inHg. The following table will help in
determining the appropriate deaeration pressure calibration point at different
elevations:
Table 2
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3.13 FLOW RELIEF PRESSURE
Verify that the flow relief pressure is between 29 and 30psi (between 35 and 36psi if a
DIASAFE filter system is installed) as follows:
2. Connect a pressure gauge in line at the output of the flow pump (See Figure 3,
pg. 8).
Note: The output side of the flow pump is the side with the white reinforced
jacket over the line. The input side has clear plastic line.
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2008K Preventive Maintenance Procedures
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3.14 CONCENTRATE AND BICARB PUMPS
Test the Concentrate and Bicarbonate diaphragm pumps as described in Section 4.3.
3.15 UF PUMP
Calibrate the UF Pump Volume (Refer to the 2008K Calibration Procedures –part
number 507296.)
3.16 CONDUCTIVITY
Verify that the dialysate conductivity measured by the internal cell in the machine
agrees with an external conductivity meter within 0.1mS/cm as described in Section
2.7.
3.17 TEMPERATURE
Verify that the dialysate temperature shown on the front panel Display screen agrees
with an external temperature meter within 0.3°C at 37°C and 39°C as described in
Section 2.8
1. Switch to the debug screens by pressing and holding the [▲] and [▼] keys at
the same time for approximately 1 sec. The main display will change
indicating that the machine is in debug mode.
2. Use the [▲] and [▼] keys to go to debug screen #4.
3. Locate the 5V value on the display screen. This value must be between
4.8V and 5.2V.
Note: If the 5V value is not within limits, the problem is most likely the
12volt supply out of tolerance. Perform the Volt Hi Lo Detect calibration
procedure. Refer to the 2008K Calibration Procedures –part number 507296.
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2008K Preventive Maintenance Procedures
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3.19 BLOOD LEAK AND DIMNESS
Verify that the blood leak level is between 4.5 and 5.2 volts and the blood dimness
level is within 5.0 ±1.0 volts as follows:
1. Switch to the debug screens by pressing and holding the [▲] and [▼] keys at
the same time for approximately 1 sec. The main display will change
indicating that the machine is in debug mode.
2. Use the [▲] and [▼] keys to go to debug screen #4.
3. Locate the LEAK value on the display screen. This value must be between
4.5V and 5.2V.
4. Locate the DIMN value on the display screen. This value must be between
4.0V and 6.0V.
Note: If these values are outside the limits given, perform a bleach rinse to
clean the glass detector tube inside the machine before considering other
repairs.
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3.20 ARTERIAL, VENOUS AND TRANSMEMBRANE PRESSURE
ARTERIAL PRESSURE
1. Inspect the internal pressure transducer protector for contamination. If
contamination is found, replace the pressure transducer protector (part
number M30971) and remove and disinfect the pressure port with 1:100
bleach for a minimum of 15 minutes.
2. Open the arterial transducer port PART. On the blood pump module to air
(atmospheric pressure). Verify that the Arterial Pressure bargraph
indicates 0.
3. Attach a syringe and a calibrated pressure meter to the PART. Port using a
T-fitting.
5. Switch to the debug screens by pressing and holding the [▲] and [▼] keys at
the same time for approximately 1 sec. The main display will change
indicating that the machine is in debug mode.
6. Use the [▲] and [▼] keys to go to debug screen #1 and locate the ART value.
7. Increase the pressure to a range of 310 – 315mmHg. Clamp off the tubing
at the PART. Port and monitor the debug ART value for 30 seconds. The
maximum allowable leakage is 2mmHg in 30 seconds.
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2008K Preventive Maintenance Procedures
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VENOUS PRESSURE
1. Inspect the internal pressure transducer protector for contamination. If
contamination is found, replace the pressure transducer protector (part
number 650158) and remove and disinfect the pressure port with 1:100
bleach for a minimum of 15 minutes.
2. Open the venous transducer port PVEN. On the level detector module to air
(atmospheric pressure). Verify that the Venous Pressure bargraph
indicates 0.
3. Attach a syringe and a calibrated pressure meter to the PVEN. Port using a
T-fitting.
5. Switch to the debug screens by pressing and holding the [▲] and [▼] keys at
the same time for approximately 1 sec. The main display will change
indicating that the machine is in debug mode.
6. Use the [▲] and [▼] keys to go to debug screen #1 and locate the VEN value.
7. Decrease the pressure to a range of 310 – 315mmHg. Clamp off the tubing
at the PVEN. Port and monitor the debug VEN value for 30 seconds. The
maximum allowable leakage is 2mmHg in 30 seconds.
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2008K Preventive Maintenance Procedures
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TRANSMEMBRANE PRESSURE
1. With dialysate flow ON, ensure the dialysate lines are full of fluid and no
air is visible passing through the flow indicator.
2. Hang a four-way connector to the I.V. pole at normal dialyzer height.
3. Set dialysate flow to 500ml/min, then press the [CONFIRM] key.
4. Open the arterial (PART.) and venous (PVEN.) transducer ports to air
(atmospheric pressure).
5. Turn the blood pump off.
6. Turn dialysate flow OFF, remove the dialysate lines from the shunt and
attach them to the connector. Close the shunt door.
Note: Filling the lines before removing them from the shunt will avoid
wetting the pressure meter transducer during the test.
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2008K Preventive Maintenance Procedures
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3.21 DIALYSATE FLOW
Verify the dialysate flow is within ±3% of the stated rate at 500ml/min as follows:
Note: All flow rates are controlled by the software. Testing the rate at
500ml/min verifies the accuracy of all rates.
1. In Dialysis Mode, turn the dialysate flow ON at 500ml/min. Verify that the
UF pump is OFF and the machine is out of bypass. Allow the dialysate flow
to run for 2 minutes, minimum, before continuing.
Note: Do not collect the spent dialysate from the drain hose in the next step.
The accuracy of the collection will be affected if not collected directly from
the drain port with the drain hose removed.
2. Collect spent dialysate from the drain port on the back of the machine (See
Figure 3, pg. 8) for exactly 1 minute. Verify that the amount collected is
between 485 and 515ml.
3. Record the measured value on the Annual/4000 Hour Preventive
Maintenance Checklist
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2008K Preventive Maintenance Procedures
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7. Extend the syringe plunger past the 10ml mark. Install the syringe into the
pump and latch the plunger handle into the carriage. If needed, squeeze the
carriage/plunger release lever to slide the carriage up to meet the plunger
handle. The syringe plunger should be at a position greater than 10ml.
CARRIAGE BAR
PLUNGER HOLDER
CARRIAGE
CARRIAGE / PLUNGER
RELEASE LEVER
8. Press the Heparin Prime button. Press and hold the [CONFIRM] key. The
plunger will start moving towards the 10ml mark. Release the [CONFIRM]
key as soon as the syringe plunger is aligned exactly with the 10ml mark on
the side of the syringe body.
9. Select the Bolus data button. Use the [▲] and [▼] keys to set a value of
5.0ml then press the [CONFIRM] key.
10. Select the Total Infused data button. Press the 0 (zero) key and then the
[CONFIRM] key.
11. Press the Infuse Bolus button. Press the [CONFIRM] key and start timing
the interval with the stopwatch.
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2008K Preventive Maintenance Procedures
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12. When the pump stops, use the table below to verify the time to run a 5ml
Bolus is correct for the selected syringe type.
13. Also, verify that the Total Infused data button reads 5.0 and that the
syringe plunger has moved to between 4.8 to 5.2 on the syringe scale.
14. Move the carriage all the way up to the end of its travel.
Note: Use the Heparin Pump Prime function to move the carriage to the end
of travel to ensure the screw gear stays fully engaged for the end of travel
alarm test.
15. Select the RATE data button. Use the [▲] and [▼] keys to set a value of
9.9ml/hr. then press the [CONFIRM] key.
16. Press the [Heparin on/off] key to start the pump. The green lamp above
the key should light.
17. Verify that a HEPARIN PUMP ALARM is displayed on the status line
within 2 minutes.
Note: If the machine is not alarm free, another message of higher priority
may be displayed on the status line.
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2008K Preventive Maintenance Procedures
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3.23 BLOOD PUMP
Clean and test the arterial blood pump module as follows:
1. Remove the blood pump rotor by opening the door, pulling out the handle
and turning the rotor 90 degrees
2. Clean the rollers with a cloth dampened only with water.
3. With the crank lever pulled out, locate and lubricate the crank lever retainer
ball. If the crank lever is hard to pull out, replace the crank lever retainer
assembly (part number 564301).
4. Without removing the plastic sleeve, inspect the solid guide post on all four
(4) tubing guides. The solid guide post should not be loose or bent. If any
of the solid guide posts are loose or bent, the rotor assembly needs to be
replaced. (Part number M30990).
Note: The plastic sleeve will make it feel like the solid guide post is loose.
When inspecting, pay close attention to the movement of the metal shaft.
5. Clean the inside of the blood pump housing with the damp cloth.
Compressed air may be used if it is available.
6. Remove the blood pump module from the machine and inspect the motor
gearbox. In heavy use, some oil may accumulate on the gearbox housing.
Wipe the housing clean.
7. Wipe the lower edge of the module and the blood pump cabinet opening to
remove any residual disinfecting agent.
8. Reassemble the blood pump module and reinstall it in the machine cabinet.
When installing the module screws do not use a power screwdriver.
9. Place the machine in Dialysis Mode and clear all blood alarms.
10. Start the blood pump if it is not already running.
11. Open the blood pump door. Verify that the red alarm light on the blood
pump module lights within 15 or 30 seconds.
Note: Delay time before the blood pump alarm lights is set by dipswitch 4 on
the LP955 blood pump board.
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2008K Preventive Maintenance Procedures
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12. Close the blood pump door and press the [RESET] key to clear the alarm.
13. Test the pump as follows:
• Set the Tubing Size to 8mm.
• Insert a bloodline in the pump. Do not change the setting of the
tubing size selector, even if you are not using 8mm tubing.
• Connect a pressure gauge to the bloodline in the pump (See
Figure 11) and allow the rotor to pull up 37°C ± 1.5°C water. Let
this fluid flow past the pressure gauge long enough to clear out
air.
Clamp
• With the pump running at 600ml/min, clamp the outlet so that the
pressure gauge is between the output of the pump and the clamp
(See Figure 11). The peak pressure on the gauge must be between
25 and 35psi. If the peak pressure is out of range, replace the
blood pump rotor springs (part number 650174).
• Set the Tubing Size Selector to agree with the size of bloodline
used in the pump.
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3.24 LEVEL DETECTOR
Perform the Quarterly Preventive Maintenance procedures in Section 2.9
3.26 VERIFY pH
1. Place the machine into dialysis mode and allow it 10 minutes to stabilize.
2. Use a pH test strip (part number 335130-01 or equivalent) to verify the
dialysate fluid is between the ANSI/AAMI RD52 standard of 6.9 and 7.6.
3. Record the measured value on the Annual/4000 Hour Preventive
Maintenance Checklist.
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2008K Preventive Maintenance Procedures
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3.27 RINSE CHECKS
Perform the Rinse Checks as follows:
1. Place the machine in rinse mode, then turn the water supply off. Verify that
the display screen shows NO WATER.
2. Turn water supply on.
3. Start rinse mode, and watch the flow from the drain line. The water from
the drain line will stop at one point for 15 seconds. At this time put the
drain line in a 1000ml graduated cylinder. Start timing when the flow starts
again. At 30 seconds, remove the line from the graduated cylinder. Verify
that a minimum of 310ml is collected.
4. Record the measured value on the Annual/4000 Hour Preventive
Maintenance Checklist.
5. To avoid problems with pre-rinse, allow the rinse to complete prior to
proceeding to the next step.
6. Open the shunt door and remove the dialysate lines.
7. Connect the dialysate lines to an external temperature meter capable of
reading at least 85°C.
8. Close the shunt door.
9. Start the machine in heat disinfect mode with the dialysate lines on the
external temperature meter as follows:
• With the shunt door closed, reach up into the opening at the bottom of the
shunt and find the two spring-loaded switches that protrude through the
holes next to the connectors. Push these switches in with your fingers,
simulating dialysate lines connected to the shunt.
• While holding these switches pushed in, press the Heat Disinfect
button on the startup screen.
• While holding the switches, open the shunt door. Verify the heat
disinfect does not get interrupted.
• Leave the shunt door open; closing it will stop the heat disinfect mode.
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2008K Preventive Maintenance Procedures
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Warning! Scalding hot water is passing through the dialysate lines and the
external meter manifold. Allow the dialysate lines and the external
temperature meter manifold to cool before disconnecting the lines.
10. The heat disinfect timer will not be operating. It is not needed. Monitor the
external temperature meter and verify that the temperature rises to between
80°C and 90°C.
Note: Some external temperature meters may not display correctly at higher
temperatures. Consult the appropriate product literature from the meter
manufacturer for applicable conversion charts.
Note: If the 9-volt battery is swollen, the power logic board is bad and should
be replaced.
With the battery removed, perform an Alarm Test and confirm the Battery Test fails.
Note: If the Battery Test passes with the 9-Volt battery removed, IC9 is bad
on the Power Logic Board and should be replaced.
Replace the 9-volt battery with a new one observing the correct polarity marked
inside the holder. Install the battery/holder assembly into the monitor unit.
With the new battery in place, perform an Alarm Test and confirm the Battery Test
passes.
Test the power failure alarm by removing the machine power plug from the wall
outlet with the machine powered on. Verify that the audible alarm sounds.
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3.29 BLOOD PRESSURE MODULE
Note: There are seven types of blood pressure modules that can be connected
to the 2008K. Since each module type has different test criteria and the 2008K
is unable to detect which module is connected, disregard the displayed
Pass/Fail results if present and use the appropriate table to determine pass or
fail.
Test the blood pressure module (See Figure 3, pg. 8), as follows:
Place the machine in Service Mode.
Select the Test BP Module button and the screen will change.
INFLATION SPEED TEST
From the Test BP Module screen, select the Inflation Speed button.
1. Connect the 10 foot blood pressure tubing from the module to the 700cc
port on the Dummy Cuff. Ensure the tubing fits snugly on the ports.
2. Press the [CONFIRM] key. The screen will change and the test will start.
3. The blood pressure module will pressurize the Dummy Cuff and report the
time. When the test is complete, use the table below to verify that the Time
to 250 value is within range dependent upon the module type installed.
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DEFLATION SPEED TEST
Note: The deflation speed test is not applicable to the SunTech module.
From the Test BP Module screen, select the Deflation Speed button.
1. Connect the 10 foot blood pressure tubing from the module to the 220cc
port on the Dummy Cuff. Ensure the tubing fits snugly on the ports.
2. Press the [CONFIRM] key. The screen will change and the test will start.
3. The blood pressure module will depressurize (deflate) the Dummy Cuff. The
screen will change and report the deflation speed at various pressures in mmHg
per second.
4. Use the table below to verify that the values reported are within the
following ranges dependent upon the module type installed.
M2000 or M2600 4.4 6.7 4.4 6.7 3.0 5.2 2.4 4.6
TM2910 or TM-2915 3.5 7.5 3.5 7.5 3.5 7.5 3.5 7.5
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2008K Preventive Maintenance Procedures
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5. Use the table below to verify that the Leak Rate value is within range
dependent upon the module type installed.
Module Type Dummy Cuff Port Leak Rate
M400, M2000 or M2600 220cc ≤15mmHg
M3600 220cc ≤12mmHg
TM-2910 or TM-2915 700cc ≤30mmHg
SunTech 700cc ≤22mmHg
CALIBRATION CHECK
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2008K Preventive Maintenance Procedures
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For the M2000, M2600, M3600 & SunTech
1. From the Test BP Module screen, select the Air Leakage button.
2. Disconnect the 10 foot blood pressure tubing from the blood pressure module.
3. Using a T-fitting, connect the blood pressure module, calibrated pressure
meter accurate to within ±1mmHg and to the appropriate module specific port
on the Test Device. (See the table below). Ensure the tubing fits snugly at all
connections.
Module Type Dummy Cuff Port
M2000, M2600 or M3600 220cc
SunTech 700cc
4. Press the [CONFIRM] key. The screen will change and the blood pressure
module will pressurize the line.
5. The blood pressure module will pressurize as indicated by a rise in the Cuff
Pressure displayed to approximately 290mmHg. An internal timer is then
activated automatically.
6. When the pressure shown on the display screen and on the external pressure
meter stabilizes, verify that they agree within ±3mmHg.
7. At the end of the Air Leakage test, the pressure is automatically released.
8. Disconnect the tubing from the blood pressure module and reconnect the
10 foot blood pressure tubing
9. Over Pressure Relief Check:
Caution: Due to the microprocessor control of the M2000, M2600, M3600
and SunTech module, the over-pressure relief check does not need to be
conducted. An over-pressure relief test could permanently damage the
module.
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4.0 REBUILDING THE DIAPHRAGM PUMPS
The machine contains two types of diaphragm pumps. The ultrafiltration (UF) pump
is a solenoid coil type. The concentrate and bicarbonate pumps are stepper motor
types.
• Do not lose the wear button or the shim washers inside the pump solenoid.
• Count the shim washers when you disassemble the pump. The number of
washers varies as needed to mate the solenoid to the pump properly.
Note: If the UF pump does not provide output even though the green light is
on and not flashing, inspect the check valves. If a check valve is installed
backwards, the pump will not work.
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WEAR BUTTON OUTLET SPRING
P/N 565219 P/N 563025
(STRONGER)
SHIM
WASHERS SEALS O-RINGS
P/N 562343 P/N 565279 P/N F40007099 or 579058
1. Remove the UF pump from the machine (See Figure 3, pg. 8). Make a note
of which line goes to which port on the pump. When looking at the end
plate, the arrow pointing into the pump nozzle is the input side. The arrow
pointing away from the pump nozzle is the output side.
2. Hold the two sections of the pump housing and end plate together with one
hand and remove the four long screws from the end plate.
3. Carefully remove the end plate to reveal the input and output nozzles,
springs, seals and O-rings.
4. Replace the inlet and outlet springs.
Caution: Be certain the correct springs are used. The weaker spring goes on
the inlet side. The stronger spring goes on the outlet side.
5. Inspect the seals. Replace them if there is any sign of swelling or wear.
6. Inspect the O-rings. Replace them if there is any sign of wear.
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2008K Preventive Maintenance Procedures
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Note: Before reassembling the UF pump, verify nothing has fallen into the
solenoid opening.
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4.2 REBUILDING THE CONCENTRATE AND BICARBONATE PUMPS
Figure 13 is an exploded view of the concentrate and bicarbonate pumps.
OUTLET
INLET
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2008K Preventive Maintenance Procedures
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3. Carefully remove the end plate to reveal the input and output nozzles,
springs, seals and O-rings.
4. Replace the inlet and outlet springs.
Caution: Be certain the correct springs are used on concentrate pumps. See
Figure 13 on previous page.
5. Inspect the seals. Replace them if there is any sign of swelling or wear.
6. Inspect the O-rings. Replace them if there is any sign of wear.
7. Reassemble the pump as follows:
• The outlet seal goes toward the pump membrane.
• The inlet seal faces away from the pump membrane.
• Reinstall the spacer in the outlet nozzle if one was removed from the
pump.
• Ensure the outlet nozzle is oriented so it will be at the top of the pump
solenoid to help avoid air locks in the pump.
8. Replace the long screws into the end plate and tighten.
9. Reinstall the pump in the machine and reconnect the electrical and hydraulic
lines. Orient the pump so the outlet nozzle is above the inlet nozzle to help
avoid air locks.
Note: To avoid discoloration of the pump wiring, route the pump wiring
away from heat sources such as the pump housing and valve coils when
reinstalling the pump.
10. To displace air and to check for leaks, start a rinse and allow the machine to
complete the entire rinse cycle.
11. Test the rebuilt diaphragm pump by performing the procedure described in
Section 4.3.
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2008K Preventive Maintenance Procedures
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4.3 TESTING CONCENTRATE AND BICARBONATE PUMPS
The concentrate (acid) and bicarbonate pumps are tested by measuring the volume of
water they pump and comparing that measurement with the expected value
determined by the machine. The measured pump volume must be within 2% of the
expected value.
Test each pump as follows:
1. Place the machine in Dialysis Mode and open the shunt door.
2. Switch to the debug screens by pressing and holding the [▲] and [▼] keys at
the same time for approximately 1 sec. The main display will change
indicating that the machine is in debug mode.
3. Use the [▲] and [▼] keys to go to debug screen #1.
• Locate the debug value for FILACT. In order to turn off dialysate flow
later, FILACT must be 0.
• Locate the debug value for DOUBLE. Certain types of Bicarbonate or
higher Bicarbonate levels selected will require the pump to double
stroke. If the debug value for DOUBLE is 1, the pump is double
stroking. Before continuing the test, adjust the Bicarbonate level until
the debug value for DOUBLE is 0.
• If the debug values for the Bicarbonate Pump Volume (BMIN and
BMAX) are showing 0 on debug screen #1, the machine is set up for a
concentrate family that does not use bicarbonate. Change the
concentrate selection to one requiring bicarbonate.
Note: The AMIN, AMAX, BMIN, BMAX are the expected limits for twenty
pulses of the acid (concentrate) pump volume and the bicarbonate pump
volume, respectively. These volumes are based on the measured volume of the
balancing chamber to produce the correct mixing ratio.
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6. With the machine in Dialysis Mode, press the [Dialysate Flow on/off] key
to start the flow. Observe that liquid is drawn from the buret in discrete
steps. Allow the machine to run and pump fluid from the buret for about 20
strokes, to prime the pump. Press the [Dialysate Flow on/off] key to stop
the flow.
Note: Do not let the buret run dry so that air can enter the system.
7. Refill the buret exactly to the full mark. Press the [Dialysate Flow on/off] key
to start the flow and count exactly 20 pulses of water drawn from the buret,
then stop the flow.
Note: If DOUBLE=1 on debug screen #1 then count each pulse of the double
stroking bicarbonate pump.
8. Measure the amount of water drawn from the buret carefully to within
0.05ml (within 1/2 division on a buret calibrated in 0.1ml increments).
Verify that this value is between the displayed limits of AMIN and AMAX
for the acid pump volume and BMIN and BMAX for the bicarbonate pump
volume.
9. If a pump volume falls outside of the permitted error, repeat the above
procedure to ensure that you are getting consistent results before re-
calibrating the machine.
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PREVENTIVE MAINTENANCE CHECKLIST
QUARTERLY/1000 HOUR
SERIAL NO. _________________________________________________DATE __________________________
MACHINE I.D. NO. ___________________________________________MACHINE HOURS ______________
TECHNICIAN(S) _____________________________________________LABOR HOURS _________________
See the Referenced Section of the 2008K Preventive Maintenance Procedures (part number
507297 Rev. L) for detailed instructions to perform the following:
2.1 Clean Filters (replace if necessary) and replace O-Rings: ................... ________
Water Inlet ............................................................................................... ________
Acid and Bicarbonate Connectors ......................................................... ________
Dialysate Inline Filter .............................................................................. ________
Dialysate Line Connectors ...................................................................... ________
2.2 Inspect Pre-UF Pump Filter ............................................ (Replace If Necessary) ________
2.3 Replace DIASAFE Filter ....................................................... (If Applicable) ________
2.4 Inspect UF Pump Check Valves ...................................... (Replace If Necessary) ________
2.5 Check High Voltage AC Connections ........................................ (<0.2 ohms) _________ ________
2.6 Calibrate UF Pump ...................................... (Range: 24 ± 0.1cc at 24 UF Pump strokes) _________ ________
2.7 Check Conductivity Calibration ............... (Range: Δ ± 0.1mS/cm) _________ _________ ________
Machine Display External Meter
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PREVENTIVE MAINTENANCE CHECKLIST
ANNUAL/4000 HOUR
SERIAL NO. _________________________________________________DATE __________________________
MACHINE I.D. NO. ___________________________________________MACHINE HOURS ______________
TECHNICIAN(S) _____________________________________________LABOR HOURS _________________
See the Referenced Section of the 2008K Preventive Maintenance Procedures (part number
507297 Rev. L) for detailed instructions to perform the following:
Reference Section Procedure Value Completed By:
3.1 Clean Filters and Replace O-Rings................................................................... __________
3.2 Replace Pre-UF Pump Filter ............................................................................. __________
3.3 Replace UF Pump Check Valves....................................................................... __________
3.4 Check Deaeration Restrictor and Replace O-Rings ........................ (If Applicable) __________
3.5 Replace DIASAFE filter .................................................................. (If Applicable) __________
3.6 Rebuild UF, Concentrate and Bicarbonate Pumps ......................................... __________
3.7 Check Ground Heater Element ........................................................................ __________
3.8 Check High Voltage AC Connections.................................................. (<0.2 ohms) __________ __________
3.9 Replace Deaeration Motor Brushes .............................................. (every 8000 hours) __________
3.10 Check Inlet Water Pressure Regulator ...................................... (Range: 18 to 20psi) __________ __________
3.11 Conduct Online Clearance Test ........................................................ (If Applicable) __________
3.12 Check Deaeration Pressure ............................................ (Range: See Table 2 on page 32) __________ __________
Check Loading Pressure ........................ (Range: 18 to 20psi / with DIASAFE filter 23 to 25psi)
®
__________ __________
3.13 Check Flow Relief Pressure................... (Range: 29 to 30psi / with DIASAFE filter 35 to 36psi)
®
__________ __________
3.14 Test Concentrate and Bicarbonate Pumps ...................................................... __________
3.15 Calibrate UF Pump ............................................. (Range: 24 ± 0.1cc at 24 UF Pump strokes) __________ __________
3.16 Check Conductivity Calibration ....................... (Range: Δ ± 0.1mS/cm) _________ _________ ________
Machine Display External Meter
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2008K Preventive Maintenance Procedures
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COMMON CONVERSIONS
PRESSURE
VOLUME
MASS
Manufactured by:
Fresenius USA, Inc.
4040 Nelson Avenue
Concord, CA 94520
800 227-2572
http://www.fmcna.com