SWS-4000 SERIES
ORDINARY MAINTENANCE PLAN
Introduction
     In order to maintain the dialysis machine good functional efficiency and reduce the likelihood of faults, the
system must be subjected to routine maintenance periodically.
     Routine maintenance is used to ensure the correct functioning of the system, and all the maintenance activities
require specific technical skills and a precise knowledge of the system and must be carried out by certified personnel
as suitable for the installation and maintenance of the machine.
    Maintenance routine is composed by activity that must be performed every 6 and 12 months; each of them
must be recorded and reported.
     Maintenance activity scheduling, description and reporting has illustrated into the next chapters.
     Note: if the records of ordinary maintenance activities on yearly basis are not found, the warranty tied to the
dialysis machines shall become automatically void.
                                                                                                                SWS-4000 SERIES
                                          Ordinary Maintenance Activity Schedule
     Annual ordinary maintenance activity scheduling:
                                          Scheduling Period (month)                                             Scheduling Period (month)
                  Activity                                                              Activity
                                              6             12                                                      6             12
1 (O-ring - Dialyzer couplings)               X             X         27 (Rust removal)                             X             X
2 (O-ring - Concentration aspirator)          X             X         28 (Silicon tube & Connection checking)       X             X
3 (O-ring - Bicart holder)                                            29 (Water leakage check & removal)
                                              X             X                                                       X             X
4 (O-ring – Endotoxin filter couplings)                               30 (Dust cleaning)
                                                            X                                                       X             X
5 (O-ring - Substitution component)                         X         31 (Cable rearranging & plug-in check)        X             X
6 (Concentrate aspirator filter)                            X         32 (Position detection sensor)                X             X
7 (Disinfectant suction tube filter)                        X         33 (Pressure sensor YG1/2/3/4)                X             X
8 (Membrane - Big filter A/B)                 X             X         34 (Pressure sensor AP/VP)                    X             X
9 (Water inlet filter)                                                35 (Air detector)
                                              X             X                                                       X             X
10 (Filter - Air fan)                                                 36 (Back-up battery)
                                                            X                                                       X             X
11 (Air filter)                                             X         37 (Touch screen)                             X             X
12 (Check valve)                                            X         38 (Button key)                               X             X
13 (Positive degassing tank QG1)                            X         39 (IV pole & Audible alarm)                  X             X
14 (Water inlet degassing tank JQ)                          X         40 (Bicart holder)                            X             X
15 (Negative degassing tank QG2)                                      41 (Blood pump)
                                                            X                                                       X             X
16 (Positive degassing tank QG3)                                      42 (Substitution pump)
                                                            X                                                       X             X
17 (Mixing tank HG1/HG2)                                    X         43 (Release valve XV1/XV2)                    X             X
18 (Resin degassing tank QG5)                               X         44 (Gear pumps YP DP)                         X             X
19 (Reducing valve JV)                                      X         45 (Level regulator)                                        X
20 (Release valve XV3/XV4)                                  X         46 (Block clamp)                                            X
21 (Endotoxin filter couplings)                                       47 (Heparin pump)
                                                            X                                                                     X
22 (Concentration aspirator A/B)                                      48 (Conductivity sensor)
                                              X             X                                                                     X
23 (Ceramic pump A / B JP1/JP2)               X             X         49 (Temperature sensor)                                     X
24 (UF pump JP3)                              X             X         50 (Balance chamber)                                        X
25 (Solenoid valve)                           X             X         51 (Blood leak detector)                                    X
26 (Dialyzer couplings)                       X             X         52 (Gear pumps QP)                                          X
                                                                                                  SWS-4000 SERIES
Ordinary Maintenance Activity Description
     All the ordinary maintenance activity that must be performed every 6 months are listed and described into the
table below:
 6 Months Ordinary Maintenance Activity
 Item            Spare Parts             Method                             Solution                          Model
         O-ring (Dialyzer couplings)
   1                                     Replace      Replace O-ring(12*2.65) of dialyzer couplings.            All
         12*2.65 x 2pcs
         O-ring (A/B Concentration
         aspirator)                                   Replace O-ring(10*1.8) of concentration
   2                                     Replace                                                                All
                                                      aspirator.
         10*1.8 x 4pcs
         O-ring (Bicart holder)                       Replace O-rings of Bi-cart holder.
         Top: 9.5*2 x 1pcs
                                                      Note:
         Bottom:9.19*2.62 x 1pcs                      (1)Replacement is depending on the use condition;
   3     Top-II: 17.12*2.62 x 1pcs       Replace      (2)Old model has one type of O-ring 9.4*2.85;             All
                                                      (3)New model Bicart has 3 types of O-ring, usually
         Old Model:                                   replace the top and bottom model, the top-II is
         9.4*2.85 x 2pcs                              depending.
                                                      Check the big filters if they are dirty or block,
                                                      unscrew and open the filter to clean/replace the
         Membrane - Big filter
                                       Maintenance    inside membrane when necessary.
   8     Type A: 180 holes                                                                                      All
                                       / Replace      Note:
         Type B: 300 holes
                                                      The big filters type B (300holes) are marked on the
                                                      surface with a red spot.
                                                      Open the filter to clean the membrane by RO
   9     Water inlet filter            Maintenance                                                              All
                                                      water flushing.
                                                      (1)Check the aspirator handle if any crystal, clean
         Concentration aspirator       Maintenance    them;
  22                                                                                                            All
         A/B                           / Replace      (2)Check if any crack on the tube and handle,
                                                      replace it.
                                                      (1)Clean the dirt on the bearings of ceramic
                                                      pumps;
                                                      (2)Give proper grease to the bearings;
         Ceramic pump A / B                           (3)Remove and clean the crystal collected in the
  23                                   Maintenance    waterproof drip tray;                                     All
         JP1/JP2
                                                      (4)Rotate the bearing on both direction on the
                                                      ceramic pumps A&B to check if they could rotate
                                                      smoothly, if not, replace pump motor or immerse
                                                      plunger in hot water with citric acid until it turns.
                                                                                                SWS-4000 SERIES
6 Months Ordinary Maintenance Activity
Item          Spare Parts            Method                              Solution                           Model
                                                 Note:
                                                 When immersing the plunger if needed, ensure the
                                                 fluid level is lower than the glue part on the shaft in
                                                 case of damage to glue;
                                                 (1)Clean the dirt on the bearings of ceramic
                                                 pumps;
                                                 (2)Give proper grease to the bearings;
                                                 (3)Rotate the bearing on both direction on the
                                                 ceramic pumps A&B to check if they could rotate
                                                 smoothly, if not, replace pump motor or immerse
 24    UF pump JP3                 Maintenance   plunger in hot water with citric acid until it turns;        All
                                                 Note:
                                                 When immersing the plunger if needed, ensure the
                                                 fluid level is lower than the glue part on the shaft in
                                                 case of damage to glue;
                                                 (4)Measure the coefficient of UF pump to ensure
                                                 the accuracy of ultrafiltration.
                                                 (1)Check if any attached crystal, remove and
                                                 clean;
                                                 (2)Check if any attached rust, remove and clean;
                                                 (3)If there is attached crystal or rust, please seek
                                                 and locate where the leakage may happen, then
 25    Solenoid valve              Maintenance   take corresponding measure;                                  All
                                                 (4)If needed, for the balance chamber valve,
                                                 please replace its sealing O-ring(5*1.8).
                                                 Note:
                                                 The potential leakage may cause unpredictable fault
                                                 on the machine, technicians are supposed to solve this
                                                 issue completely during maintenance.
                                                 (1)Check both couplings if any attached crystal,
                                   Maintenance   remove and clean them;
 26    Dialyzer couplings                                                                                     All
                                   / Replace     (2)Visually check if any crack and any anomaly on
                                                 the appearance, maintenance or replace.
 27    Rust & Crystal removal       Cleaning     Remove all rust and crystal on the hydraulic parts           All
                                                 (1)Check silicon tubing if any crack, especially on
       Silicon tube & Connection                 the electrode and valve connectors;
 28                                Maintenance                                                                All
       checking                                  (2)Visually check all tube connectors and ensure
                                                 all connectors are tightly connected.
                                                                                                 SWS-4000 SERIES
6 Months Ordinary Maintenance Activity
Item          Spare Parts                Method                            Solution                           Model
       Water leakage check &                         Visually check if any water leakage, ensure it is
 29                                    Maintenance                                                             All
       removal                                       dry and clean at the inner bottom of machine.
                                                     Check internal space if any dust, clean them.
 30    Dust cleaning                    Cleaning     Note:                                                     All
                                                     For the circuit board cleaning, please clean them with
                                                     static brush.
       Cable rearranging & plug-in                   Rearrange all cable and ensure circuit connectors
 31                                    Maintenance                                                             All
       check                                         are tightly plugged in.
                                                     (1)Enter Monitor -> Sensor interface to test and
                                                     validate the function of position sensors;
 32    Position detection sensor        Validation                                                             All
                                                     (2)Ensure the sensor component is positioned
                                                     tightly.
                                                     (1)Connect in serial with a pressure gauge and
                                                     syringe;
                                                     (2)Enter Calibration -> Pressure interface to test
                                                     and validate the function of pressure sensors,
 33    Pressure sensor YG1/2/3/4        Validation   check at “0” & “100Kpa” point.                            All
                                                     Note:
                                                     Ensure the error difference of the value between the
                                                     gauge and the screen is ±3kpa, if not please
                                                     recalibrate the corresponding pressure sensor.
                                                     (1)Connect in serial with a pressure gauge and
                                                     syringe;
                                                     (2)Enter Calibration -> Pressure interface to test
                                                     and validate the function of pressure sensors,
                                                     check at “0” & “100mmHg” point and the value is
 34    Pressure sensor AP/VP            Validation                                                             All
                                                     stable without drop or fluctuation.
                                                     Note:
                                                     Ensure the error difference of the value between the
                                                     gauge and the screen is ±5mmHg, if not please
                                                     recalibrate the corresponding pressure sensor.
                                                     (1)Prepare a tube filled with water and syringe,
                                                     install in the air detector ;
                       Air detection
                                                     (2) Test and validate the function of air monitor
          Air                                        in the Information II interface;
 35                                     Validation                                                             All
        detector
                                                     Block the led light inside of the detector, validate
                          Blood
                                                     the status of the blood recognition in the
                       recognition
                                                     Information II interface.
                                                                                         SWS-4000 SERIES
6 Months Ordinary Maintenance Activity
Item           Spare Parts          Method                           Solution                        Model
                                                 When city power shut down, machine could
                                                 automatically switch to back-up power supply
 36    Back-up battery              Validation                                                         All
                                                 and maintain blood pump working stably for
                                                 30mins.
                                                 LCD displays well and touch screen acts properly
 37    Touch screen                 Validation                                                         All
                                                 by manually clicking.
                                                 Button key act properly and could be detected in
 38    Button key                   Validation                                                         All
                                                 Monitor -> Blood/Water/Electric -> Hot key.
                                                 Perform IV pole led and loudspeaker test in
 39    IV pole & Audible alarm      Validation                                                         All
                                                 Monitor -> Blood/Water/Electric -> Led.
       Bicart holder
 40                               Maintenance    Remove attached crystal and clean the holder.         All
                                                 (1)Take out pump roller and validate with
                                                 calibrator;
 41    Blood pump                 Maintenance                                                          All
                                                 (2)Remove dirt & clean the pump internally and
                                                 externally.
                                                 (1)Take out pump roller and validate with
                                                 calibrator;
 42    Substitution pump          Maintenance                                                        4000
                                                 (2)Remove dirt & clean the pump internally and
                                                 externally.
                                                 (1)Tighten 4 screws which fix the component;
 43    Release valve XV1/XV2      Maintenance    (2)Validate the YG2 YG4 value in the Monitor ->       All
                                                 Others -> XV1 XV2 test, ensure the range 150±5
                                                 kpa.
                                                 (1)Remove all dust and clean the pump surface;
 44    Gear pumps YP DP           Maintenance                                                          All
                                                 (2)Ensure the tubes are tightly connected.
                                                                                                      SWS-4000 SERIES
       All the ordinary maintenance activity that must be performed every 12 months are listed and described
including the above table “6 Months Ordinary Maintenance Activity” and the table below:
 12 Months Ordinary Maintenance Activity
 Item               Spare Parts             Method                             Solution                           Model
           O-ring (Endotoxin filter
           couplings)                                   Replace O-ring (12*2.65) of endotoxin filter
   4                                        Replace                                                                 All
           4000A : 12*2.65 x 4pcs                       couplings.
            4000 : 12*2.65 x 8pcs
                                                        Replace O-ring (10*1.8) of Substitution
           O-ring (Substitution                         component and clean.
   5       component)                       Replace     Note:                                                     4000
           10*1.8 x 1pcs                                V4.8 model has a silicon pad only;
                                                        V4.9 model has O ring.
                                          Maintenance   Check if the filter still working, if any broken
   6       Concentrate aspirator filter                                                                             All
                                           / Replace    replace it.
           Disinfectant suction tube      Maintenance   Check if the filter still working, if any broken
   7                                                                                                                All
           filter                          / Replace    replace it.
                                                        (1)Check if the air fan filter is dusty, take it out
                                                        and then clean.
                                           Cleaning /   (2)If the membrane is broken, replace it.
  10       Filter - Air fan                                                                                         All
                                            Replace
                                                        Note:
                                                        If clean the membrane with water, before installing
                                                        back, please ensure it is completely dry.
           Air filter
                                          Maintenance
  11       4000A: x 1 pcs                               Check if filter is dusty, replace if dirty.                 All
                                           / Replace
           4000: x 2 pcs
                                          Maintenance   Check if any leakage on the surface of the check
  12       Check valve                                                                                              All
                                           / Replace    valve, replace them when necessary.
                                                        (1)Check if any leakage on the surface and the
           Positive degassing tank                      juncture of the tank;
  13                                      Maintenance                                                               All
           QG1
                                                        (2)The O-ring(56*2) must be replaced when it
                                                        was broken.
                                                                                             SWS-4000 SERIES
12 Months Ordinary Maintenance Activity
Item          Spare Parts             Method                            Solution                         Model
                                                  (1)Check if any leakage on the surface and the
                                                  juncture of the tank;
                                                  (2)Check the floater action status, if not go with
                                                  the water level then have to find the cause;
       Water inlet degassing tank                 (3)The O-ring (56*2) must be replaced when it
 14                                 Maintenance                                                            All
       JQ                                         was broken;
                                                  (4)Observe the JQ H(YJ1)/L(YK) sensor status in
                                                  the real-time Information I screen and L(YK)
                                                  sensor by close the RO supply to machine, it
                                                  should give an alarm “water supply failure”.
                                                  (1)Check if any leakage on the surface and the
                                                  juncture of the tank;
                                                  (2)Check the floater action status, if not go with
       Negative degassing tank                    the water level then have to find the cause;
 15                                 Maintenance                                                            All
       QG2
                                                  (3)The O-ring (56*2) must be replaced when it
                                                  was broken;
                                                  (4)Ensure the QG2 H(YJ3)/L(YJ2) sensor status in
                                                  the real-time Information I screen is correct.
                                                  (1)Check if any leakage on the surface and the
       Positive degassing tank                    juncture of the tank;
 16                                 Maintenance                                                            All
       QG3                                        (2)The O-ring (56*2) must be replaced when it
                                                  was broken.
                                                  (1)Check if any leakage on the surface and the
                                                  juncture of the tank;
 17    Mixing tank HG1/HG2          Maintenance                                                            All
                                                  (2)The O-ring (40*2) must be replaced when it
                                                  was broken.
                                                  (1)Check if any leakage on the surface and the
                                                  juncture of the tank;
 18    Resin degassing tank QG5     Maintenance   (2)Replace if the resin particles are dirty;             All
                                                  (3)The O-ring (40*2) must be replaced when it
                                                  was broken.
                                                  (1)Check if any leakage;
                                                  (2)Tighten the fixing screw and the tubing
 19    Reducing valve JV            Maintenance   connection;                                              All
                                                  (2) Check with external pressure gauge, Ensure
                                                  the maximal outlet pressure ranges 1.0-1.1 bar.
                                                                                               SWS-4000 SERIES
12 Months Ordinary Maintenance Activity
Item           Spare Parts            Method                            Solution                           Model
                                                  (1)Check if any leakage;
 20    Release valve XV3/XV4        Maintenance                                                              All
                                                  (2)Ensure the inlet pressure ranges 45±5 kpa.
                                                  (1)Remove the dirt;
 21    Endotoxin filter couplings   Maintenance                                                              All
                                                  (2)Replace O ring as mentioned before.
                                                  Validate the function when blood pump is
 45    Level regulator              Maintenance                                                              All
                                                  working for level down & up.
                                                  (1)Clean the rust (if any) and dirt on the
                                                  component;
 46    Block clamp                  Maintenance                                                              All
                                                  (2)Validate the function in the Monitor ->
                                                  Blood/Water/Electric -> Block clamp.
                                                  (1)Clean the dirt on the component;
 47    Heparin pump                 Maintenance                                                              All
                                                  (2)Validate the function in the Monitor ->
                                                  Blood/Water/Electric -> Hep.F.F. / Hep.F.B.
                                                  (1)Check if any leakage on the components;
                                                  (2)Connect a conductivity reference meter (e.g.
                                                  HDM97) and enter Conductivity calibration
       Conductivity sensor
 48                                 Maintenance   interface, validate the conductivity sensor, the           All
       DG1, DG2, DG3
                                                  acceptable deviation range ±0.3mS/cm.
                                                  (3)If the sensor gets error, please perform
                                                  calibration or replace.
                                                  (1)Check if any leakage on the components;
                                                  (2)Connect a temperature reference meter (e.g.
                                                  HDM97) and enter Temperature calibration
                                                  interface, validate the temperature sensors
                                                  Temp.A, Temp.B, Temp.C (WG2 WG3 WG4), the
       Temperature sensor
 49    Temp.A, Temp.B, Temp.C       Maintenance   acceptable deviation range ±0.3℃;                          All
       (WG2 WG3 WG4)                              (3)If the sensor gets error, please perform
                                                  calibration or replace;
                                                  (4)Enter Standby interface, validate the
                                                  temperature sensors WG6, the acceptable
                                                  deviation range ±0.3℃.
                                                                                            SWS-4000 SERIES
 12 Months Ordinary Maintenance Activity
 Item           Spare Parts             Method                          Solution                         Model
                                                    (1)Check if any leakage on the valve, chamber;
                                                    (2)Remove the crystal and dirt on the chamber;
                                                    (3)Dry the water leakage (if any) on the chamber;
  50    Balance chamber              Maintenance    (4)Rearrange the cable and tubing to prevent          All
                                                    kinking;
                                                    (5)Replace the O ring (5*1.8) when necessary;
                                                    (6)Properly tighten screws on the chamber.
  51    Blood leak detector          Maintenance    Check if any leakage and ensure no tube kinking.      All
                                                    In the Standby ensure YG1 (negative pressure)
  52    Gear pumps QP                Maintenance    range from -80 ~-90kpa, if not, adjust the QP rate    All
                                                    accordingly.
Ordinary Maintenance Activity Reporting
     Ordinary maintenance routine is composed by activity that must be performed every 6 and 12 months; every
activity must be recorded using the appropriated modules listed below:
 Scheduling Period (month)       Reporting module name/code
               6                 SWS4000 Series Ordinary Maintenance Activity Report_06M
              12                 SWS4000 Series Ordinary Maintenance Activity Report_12M
                                                       Record format number:G02-84
                     SWS Hemodialysis Care Co., Ltd    Version:V2.00
   Ordinary Maintenance Activity Report_06M            Pages:1/1                   Effective date:2018-05-14
          SWS4000 Series Ordinary Maintenance Activity Report_06M
 Center                                               S/N                                   Model
                                                                                                    Note &
               Items                                         Content                           OK
                                                                                                    Remark
          Dialyzer Coupling                           Replace O-ring & cleaning                 ☐
     Concentration Aspirator              Replace O ring & cleaning & check Suction filter      ☐
            Bi-cart holder                            Replace O ring & cleaning                 ☐
            Big filter A/B                   Clean/Replace the membrane (& O ring)              ☐
          Water inlet filter                                  Cleaning                          ☐
 Ceramic pumps A/B/UF JP1/2/3                         Maintenance & cleaning                    ☐
           Solenoid valve                             Maintenance & cleaning                    ☐
     Rust & Crystal removal                      Ensure there is no crystal and rust            ☐   △
Silicon tube & Connection checking         Ensure all silicon tubing connection are tight       ☐
 Water leakage check & removal                  Ensure no leakage & parts all clean             ☐   △
            Dust cleaning                       Ensure a dry and clean inner space              ☐   △
Cable rearranging & plug-in check         Ensure cable sequence and tighten connectors          ☐
    Position detection sensor                Ensure all position sensor works correctly         ☐
   Pressure sensor YG1/2/3/4                          Error range within±3kPa                   ☐
      Pressure sensor AP/VP                 Error range within±5mmHg without leaking            ☐
            Air detector                Validate air detection & blood recognition feature      ☐
           Back-up battery                 Auto switch back-up power & BP for 30mins            ☐
            Touch screen                        LCD & Touch screen react properly               ☐
             Button key                               Button key react properly                 ☐
     IV pole & Audible alarm                  Ensure the audible & visual alarm signal          ☐
            Blood pump                                Maintenance & Cleaning                    ☐
            Subs. pump                                Maintenance & Cleaning                    ☐
     Release valve XV1/XV2               Maintenance & validate the calibrated pressure         ☐
          Gear pumps YP DP                            Maintenance & Cleaning                    ☐
       Service by:                                               Confirmed by:
       Date:                                                     Date:
                                                         Record format number:G02-84
                     SWS Hemodialysis Care Co., Ltd      Version:V2.00
   Ordinary Maintenance Activity Report_12M              Pages:1/1                    Effective date:2018-05-14
          SWS4000 Series Ordinary Maintenance Activity Report_12M
 Center                                               S/N                                    Model
                                                                                                      Note &
               Items                                          Content                         OK
                                                                                                      Remark
    Endotoxin filter couplings                        Replace O-ring & cleaning                ☐
     Substitution component                           Replace O-ring & cleaning                ☐
      Concentrate aspirator               Replace O ring & cleaning & check Suction filter     ☐
  Disinfectant suction tube filter                    Check the filter availability            ☐
           Filter - Air fan                              Cleaning or replace                   ☐
               Air filter                                Replace when dusty                    ☐
            Check valve                                  Check if any leakage                  ☐
   Positive degassing tank QG1           Check any leakage and replace O ring accordingly      ☐
                                           Check leakage and replace O ring accordingly
  Water inlet degassing tank JQ                                                                ☐
                                           Validate reed switch sensor & floater function
                                           Check leakage and replace O ring accordingly
  Negative degassing tank QG2                                                                  ☐
                                           Validate reed switch sensor & floater function
   Positive degassing tank QG3           Check any leakage and replace O ring accordingly      ☐
      Mixing tank HG1/HG2                Check any leakage and replace O ring accordingly      ☐
    Resin degassing tank QG5             Check any leakage and replace O ring accordingly      ☐
          Reducing valve JV             Maintenance and validate the outlet max. pressure      ☐
     Release valve XV3/XV4                  Maintenance and validate the inlet pressure        ☐
           Level regulator                              Validate the function                  ☐
            Block clamp                        Cleaning and validate the function              ☐
           Heparin pump                        Cleaning and validate the function              ☐
Conductivity sensor DG1,DG2,DG3             Check & Validate, error range ±0.3mS/cm            ☐
 Temperature         WG2,WG3, WG4              Check & Validate, error range ±0.3℃             ☐
   sensor                     WG6              Check & Validate, error range ±0.3℃             ☐
          Balance chamber                     Maintenance & Cleaning, Tightening               ☐
       Blood leak detector                              Check & Maintenance                    ☐
          Gear pumps QP                      Maintenance & Validate the YG1 pressure           ☐
       Service by:                                             Confirmed by:
       Date:                                                   Date: