Fresenius Medical Care 4008 S User manual

4008 S
Hemodialysis device
Service Manual
Software version: 11.40 and higher
Edition: 7/01.13
Part no.: M49 985 1
0123

Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13 iii
Table of contents
1Index
2 Important information
2.1 How to use the Service Manual................................................................................................ 2-1
2.2 Significance of the warning...................................................................................................... 2-1
2.3 Significance of the note............................................................................................................ 2-2
2.4 Precautions for working on the device ................................................................................... 2-2
2.5 Technical documentation ......................................................................................................... 2-3
2.6 Warnings .................................................................................................................................... 2-3
2.6.1 Warnings relating to hygiene ....................................................................................................... 2-3
2.6.2 Warnings relating to electricity..................................................................................................... 2-3
2.7 Addresses .................................................................................................................................. 2-4
3 Installation
3.1 Important initial start-up information ...................................................................................... 3-1
3.2 Important information for use in a domestic environment.................................................... 3-2
3.3 Initial start-up report ................................................................................................................. 3-2
3.4 Explanations for the initial start-up report.............................................................................. 3-6
3.5 Transportation of hemodialysis unit ..................................................................................... 3-28
4 Specifications
4.1 Dimensions and weight ............................................................................................................ 4-1
4.2 Type label (identification of the device) .................................................................................. 4-2
4.3 Operating environment ............................................................................................................. 4-3
4.4 Electrical safety ......................................................................................................................... 4-3
4.5 Electrical supply........................................................................................................................ 4-4
4.6 Fuses .......................................................................................................................................... 4-4
4.7 Supply mains ............................................................................................................................. 4-5
4.8 Guidance and manufacturer’s declaration for EMC
(IEC 60601-1-2)........................................................................................................................... 4-8
4.8.1 Electromagnetic emissions.......................................................................................................... 4-8
4.8.2 Electromagnetic immunity ........................................................................................................... 4-8
4.8.3 Recommended separation distances between portable and mobile RF

iv Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13
telecommunication devices and the device ............................................................................... 4-10
4.9 Operating conditions............................................................................................................... 4-11
4.10 Consumption data / energy data............................................................................................ 4-12
4.11 Storage conditions .................................................................................................................. 4-13
4.12 External connection options .................................................................................................. 4-13
4.13 Override conditions................................................................................................................. 4-14
4.14 Materials used.......................................................................................................................... 4-15
5 Setup / service program
5.1 Service mode ............................................................................................................................. 5-1
5.1.1 Service mode overview................................................................................................................ 5-1
5.1.2 Service mode key functions......................................................................................................... 5-2
5.1.3 SETUP MENU ............................................................................................................................. 5-3
5.1.3.1 SETUP MENU - menu structure................................................................................... 5-3
5.1.3.2 Part 1: Setting alarm and warning times ...................................................................... 5-4
5.1.3.3 Part 2: Setting the cleaning program............................................................................ 5-6
5.1.3.4 Part 3: Mixing ratio .....................................................................................................5-11
5.1.3.5 Part 4: Setting the conductivity limit ........................................................................... 5-15
5.1.3.6 Part 5: Cleaning program info sound.......................................................................... 5-15
5.1.3.7 Part 6: Setting dialysis parameters............................................................................. 5-15
5.1.3.8 Part 7: Cumulated blood volume ................................................................................ 5-19
5.1.3.9 Part 8: OCM settings .................................................................................................. 5-19
5.1.3.10 Part 9: Automatically starting Single-Needle mode .................................................... 5-20
5.1.3.11 Part 10: Activating Monit_NTC 109 ............................................................................ 5-21
5.1.3.12 Part 11: UF settings....................................................................................................5-21
5.1.3.13 Part 12: Setting the priming time ................................................................................ 5-21
5.1.3.14 Part 13: Sound I/O switch........................................................................................... 5-22
5.1.3.15 Part 14: Activating the key click.................................................................................. 5-22
5.1.3.16 Part 15: Setting the BPR/UFR warning ...................................................................... 5-22
5.1.3.17 Part 16: Setting the rinse volume ............................................................................... 5-23
5.1.3.18 Part 17: T1 test autostart............................................................................................ 5-23
5.1.3.19 Part 18: Setting the venous alarm window ................................................................. 5-23
5.1.3.20 Part 19: Setting central delivery ................................................................................. 5-24
5.1.3.21 Part 20: AutoOFF after AutoON ................................................................................. 5-24
5.1.3.22 Part 21: CAMUS baud rate......................................................................................... 5-25
5.1.3.23 Part 22: BPM settings (optional)................................................................................. 5-25
5.1.3.24 Part 23: Storing default values ................................................................................... 5-29
5.1.3.25 SETUP MENU settings .............................................................................................. 5-29
5.1.4 DIAGNOSTICS .......................................................................................................................... 5-32
5.1.4.1 DIAGNOSTICS, general information.......................................................................... 5-32
5.1.4.2 DIAGNOSTICS menu structure.................................................................................. 5-34
5.1.4.3 Reading the analog inputs of CPU 1 .......................................................................... 5-35
5.1.4.4 Reading the analog inputs of CPU 2 .......................................................................... 5-37
5.1.4.5 Reading the digital inputs of CPU 1 ........................................................................... 5-38
5.1.4.6 Reading the digital inputs of CPU 2 ........................................................................... 5-43
5.1.4.7 Setting the analog outputs of CPU 1 .......................................................................... 5-47
5.1.4.8 Setting the analog outputs of CPU 2 .......................................................................... 5-48
5.1.4.9 Setting the digital outputs of CPU 1 ........................................................................... 5-48
5.1.4.10 Setting the digital outputs of CPU 2 ........................................................................... 5-54
5.1.4.11 Setting / reading the digital outputs of CPU 1 ............................................................ 5-57

Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13 v
5.1.4.12 HPU............................................................................................................................ 5-58
5.1.4.13 BPM (option) .............................................................................................................. 5-59
5.1.5 MISCELLANEOUS .................................................................................................................... 5-60
5.1.5.1 MISCELLANEOUS menu structure............................................................................ 5-60
5.1.5.2 System clock .............................................................................................................. 5-61
5.1.5.3 SW-VERSION-NUMBER ........................................................................................... 5-62
5.1.5.4 BPM (option) .............................................................................................................. 5-62
5.1.6 CALIBRATION........................................................................................................................... 5-63
5.2 DIP switch overview ................................................................................................................ 5-64
5.2.1 P.C.B. LP 1631 (CPU 1) DIP switch array 1.............................................................................. 5-64
5.2.2 P.C.B. LP 1631 (CPU 1) DIP switch array 2.............................................................................. 5-65
5.2.3 P.C.B. LP 1631 (CPU 1) DIP switch array 3.............................................................................. 5-66
5.2.4 P.C.B. LP 632 (CPU 2) DIP switch array 1................................................................................ 5-68
5.2.5 P.C.B. LP 632 (CPU 2) DIP switch array 2................................................................................ 5-69
5.2.6 P.C.B. LP 634: DIP switch (array 1) .......................................................................................... 5-70
5.3 Software update....................................................................................................................... 5-71
5.3.1 Error code table ......................................................................................................................... 5-72
5.4 Service program (Quick Guide).............................................................................................. 5-74
6 TSC / maintenance
6.1 Important information for TSC / maintenance procedures.................................................... 6-1
6.2 Accessories and supplies ........................................................................................................ 6-2
6.3 TSC / MA test report .................................................................................................................. 6-2
6.4 Explanations on the test report – TSC / MA
TSC, explanations on test report ............................................................................................. 6-6
6.5 Test report – TSC..................................................................................................................... 6-32
7 Error messages
7.1 T1 Test........................................................................................................................................ 7-1
7.1.1 Prerequisites for starting and running the test............................................................................. 7-1
7.1.2 Bypass test .................................................................................................................................. 7-1
7.1.3 Opt. detector test ......................................................................................................................... 7-2
7.1.4 Blood system test ........................................................................................................................ 7-3
7.1.5 Ven. pressure system test ........................................................................................................... 7-5
7.1.6 Air detector test ........................................................................................................................... 7-6
7.1.7 Display test .................................................................................................................................. 7-8
7.1.8 Art. pressure system test............................................................................................................. 7-8
7.1.9 Battery test .................................................................................................................................. 7-8
7.1.10 Blood leak test ............................................................................................................................. 7-9
7.1.11 Temperature test ......................................................................................................................... 7-9
7.1.12 Negative pressure test (negative pressure holding test) ........................................................... 7-10
7.1.13 Positive pressure test (positive pressure holding test) .............................................................. 7-11
7.1.14 UF function test ......................................................................................................................... 7-14
7.1.15 Conductivity test ........................................................................................................................ 7-15
7.1.16 DIASAFE plus test/ HPU test .................................................................................................... 7-16
7.2 Device error during cleaning programs ................................................................................ 7-18

vi Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13
7.2.1 V84 monitoring........................................................................................................................... 7-18
7.2.2 PSW (pressure switch) monitoring during free rinsing
(only with devices with CDS) ..................................................................................................... 7-19
7.2.3 Rinse section test (check of V91, V99, V100) (only devices with CDS) .................................... 7-22
7.2.4 Rinse section test (check of V91 and V98) (only devices without CDS).................................... 7-23
7.2.5 Rinse section test (check of V91, V99, V100, V130) (only devices without CDS)..................... 7-23
7.2.6 V39 Test .................................................................................................................................... 7-25
7.2.7 Further messages which may be displayed before or during a cleaning program .................... 7-25
7.3 Error messages after turning power on ................................................................................ 7-28
7.4 Error messages during treatment.......................................................................................... 7-29
7.4.1 HPU (hydraulic processing unit) error messages ...................................................................... 7-32
7.4.2 Blood pump (arterial) error messages .......................................................................................7-34
7.4.3 Heparin pump error messages .................................................................................................. 7-34
7.4.4 BPM module error messages .................................................................................................... 7-35
8 Tools (service equipment)
9 Calibration / adjustment
9.1 CALIBRATION............................................................................................................................ 9-1
9.1.1 Settings without menu display ..................................................................................................... 9-1
9.1.2 CALIBRATION menu structure.................................................................................................... 9-2
9.1.3 Part 1: Calibrating the arterial pressure ....................................................................................... 9-4
9.1.4 Part 2: Calibrating the pressure in the arterial blood pump ......................................................... 9-5
9.1.5 Without menu display: Setting the blood pump stop alarm.......................................................... 9-6
9.1.6 Part 3: Calibrating the venous pressure ...................................................................................... 9-7
9.1.7 Part 4: Calibrating the venous pressure measurement in the air detector................................... 9-8
9.1.8 Part 5: Calibrating the blood pump rate ....................................................................................... 9-9
9.1.9 Part 5.1: Calibrating the arterial blood pump rate........................................................................ 9-9
9.1.10 Part 5.2: Calibrating the SN blood pump rate (option)............................................................... 9-10
9.1.11 Without menu display: Calibrating the Single-Needle blood pump
(Single-Needle pressure) (optional)........................................................................................... 9-11
9.1.12 Part 6: Measuring the volume of the UF pump in liters.............................................................. 9-12
9.1.13 Part 7: Calibrating the degassing pressure................................................................................9-13
9.1.14 Part 8: Calibrating the 300 flow rate .......................................................................................... 9-13
9.1.15 Without menu display: Adjusting the current increasing pulse .................................................. 9-14
9.1.16 Alternative method of adjusting the current increase
(if an oscilloscope is not available) ............................................................................................ 9-14
9.1.17 Part 9: Calibrating the 500 flow rate .......................................................................................... 9-15
9.1.18 Part 10: Calibrating the 800 flow rate ........................................................................................ 9-16
9.1.19 Part 11: Calibrating the dialysate temperature .......................................................................... 9-16
9.1.20 Part 11.1: Setting the dialysate temperature ............................................................................. 9-17
9.1.21 Part 11.2: Check the dialysate temperature .............................................................................. 9-18
9.1.22 Part 11.3: Checking the dialysate temperature for OCM ........................................................... 9-19
9.1.23 Part 12: Calibrating the mixing system ...................................................................................... 9-20
9.1.24 Part 12.1: Running in the membrane pumps............................................................................. 9-20
9.1.25 Part 12.2: Determining the balancing chamber volume............................................................. 9-21
9.1.26 Part 12.3: Calibrating the concentrate pump stroke .................................................................. 9-22
9.1.27 Part 12.4: Measuring the volume of the concentrate pump in liters........................................... 9-23
9.1.28 Part 12.5: Calibrating the bicarbonate pump stroke .................................................................. 9-24

Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13 vii
9.1.29 Part 12.6: Measuring the volume of the bicarbonate pump in liters .......................................... 9-25
9.1.30 Part 12.7: Checking the concentrate and bicarbonate volumes ................................................ 9-26
9.1.31 Part 13: Calibrating the conductivity .......................................................................................... 9-27
9.1.32 Part 13.1: Conductivity setting................................................................................................... 9-28
9.1.33 Part 13.2: Temperature/conductivity compensation setting....................................................... 9-29
9.1.34 Part 13.3: Calibrating the OCM pulse........................................................................................ 9-30
9.1.35 Part 13.4: Conductivity test........................................................................................................ 9-31
9.1.36 Part 13.5: Checking the OCM conductivity................................................................................ 9-32
9.1.37 Part 13.6: Temperature / conductivity compensation test ......................................................... 9-33
9.1.38 Part 14: Calibrating the dialysate pressure................................................................................ 9-34
9.1.39 Part 14.1: Dialysate Pressure.................................................................................................... 9-35
9.1.40 Part 14.2: TMP-Check ............................................................................................................... 9-36
9.1.41 Part 14.3: PDIAL2 press-check ................................................................................................. 9-36
9.1.42 Part 15: Blood leak voltage........................................................................................................ 9-37
9.1.43 Part 16: Calibrating the bibag®values ...................................................................................... 9-38
9.1.44 Part 17: Reset the failure record................................................................................................ 9-38
9.1.45 Part 18: Initializing the NOVRAM, clearing the mandatory rinse, erasing a
V84 malfunction......................................................................................................................... 9-39
9.1.46 Without menu display: Setting the Hall sensors in the heparin pump ....................................... 9-39
9.2 Hydraulics unit......................................................................................................................... 9-42
9.2.1 Reduced water inlet pressure.................................................................................................... 9-42
9.2.2 Degassing pump pressure......................................................................................................... 9-43
9.2.3 Balancing chamber loading pressure ........................................................................................ 9-45
9.2.4 Flow pump pressure .................................................................................................................. 9-46
9.2.5 UF pump volume ....................................................................................................................... 9-47
9.2.6 CDS (Central Delivery System) pressure switch ....................................................................... 9-48
9.2.7 Verification of the bibag®pressure transducer (Envec)............................................................. 9-50
9.3 Air Detector .............................................................................................................................. 9-51
9.3.1 Calibration of air detector LD 22................................................................................................ 9-51
9.3.1.1 Adjustment using the set for air detector calibration (see adjustment instructions) ... 9-53
9.3.1.2 Checking the venous occlusion clamp ....................................................................... 9-54
9.3.1.3 Calibrating and checking the optical detector............................................................. 9-54
9.3.1.4 Alternative: Adjustment without the set for air detector calibration............................. 9-55
10 Servicing / repair
10.1 Precautions for working on the hemodialysis device.......................................................... 10-1
10.2 Equipment................................................................................................................................10-2
10.3 Component overview .............................................................................................................. 10-3
10.3.1 Monitor....................................................................................................................................... 10-3
10.3.2 Extracorporeal Blood Circuit Module (EBM).............................................................................. 10-4
10.3.3 Hydraulics rear .......................................................................................................................... 10-5
10.3.4 Hydraulics, lateral view from the left.......................................................................................... 10-6
10.3.5 Hydraulics, lateral view from the right........................................................................................ 10-7
10.3.6 Hydraulics legend ...................................................................................................................... 10-8
10.3.7 Assignment of the hydraulic processing unit (HPU) .................................................................. 10-9
10.4 Assembly of components..................................................................................................... 10-10
10.4.1 Self-cutting screws .................................................................................................................. 10-10
10.4.2 Torques ................................................................................................................................... 10-10
10.5 Housing and cart ................................................................................................................... 10-11
10.5.1 Tilting the device...................................................................................................................... 10-11

viii Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13
10.5.2 Brake rollers............................................................................................................................. 10-11
10.5.3 Brakes...................................................................................................................................... 10-12
10.5.4 Shunt interlock ......................................................................................................................... 10-13
10.5.4.1 Shunt interlock complete .......................................................................................... 10-13
10.5.4.2 Microswitch............................................................................................................... 10-14
10.6 Power supply unit and battery ............................................................................................. 10-15
10.6.1 Removing the power cable ...................................................................................................... 10-15
10.6.2 Power supply unit .................................................................................................................... 10-15
10.6.2.1 Power board ............................................................................................................. 10-16
10.6.2.2 Heater board ............................................................................................................ 10-16
10.6.3 Battery ..................................................................................................................................... 10-17
10.7 Monitor.................................................................................................................................... 10-17
10.7.1 Opening the monitor ................................................................................................................ 10-17
10.7.2 Removing and installing the printed circuit boards .................................................................. 10-18
10.7.3 P.C.B. LP 630 Motherboard..................................................................................................... 10-18
10.7.4 P.C.B. LP 636 External I/O board............................................................................................ 10-19
10.7.5 Display..................................................................................................................................... 10-19
10.7.5.1 Removing the complete front panel.......................................................................... 10-19
10.7.5.2 P.C.B. LP 922........................................................................................................... 10-20
10.7.5.3 MDC-II board and backlight inverter......................................................................... 10-20
10.7.5.4 TFT display............................................................................................................... 10-21
10.7.5.5 Backlighting .............................................................................................................. 10-21
10.7.6 Operation status indicator (traffic light) .................................................................................... 10-22
10.8 Hydraulics unit....................................................................................................................... 10-23
10.8.1 Completely removing the hydraulic unit................................................................................... 10-23
10.8.2 P.C.B. LP 941 HPU with distribution bar ................................................................................. 10-24
10.8.3 Heater block, heater rod and float switch ................................................................................ 10-25
10.8.3.1 Heater block complete.............................................................................................. 10-25
10.8.3.2 Float switch .............................................................................................................. 10-26
10.8.3.3 Heater rod ................................................................................................................ 10-27
10.8.4 Multifunction block ................................................................................................................... 10-30
10.8.5 Balancing chamber.................................................................................................................. 10-31
10.8.6 Heat exchanger ....................................................................................................................... 10-31
10.8.7 UF pump.................................................................................................................................. 10-32
10.8.8 Membrane pump (Conc/Bic).................................................................................................... 10-33
10.8.9 Gear pump............................................................................................................................... 10-34
10.8.9.1 Pump ........................................................................................................................ 10-34
10.8.9.2 Motor ........................................................................................................................ 10-34
10.8.10 Blood leak detector.................................................................................................................. 10-35
10.8.11 Valves (type)............................................................................................................................ 10-36
10.8.12 Disinfection valve V84 with CD monitor................................................................................... 10-37
10.8.13 Suction tube............................................................................................................................. 10-38
10.8.13.1Suction rod, rivet, sealing plunger ............................................................................ 10-38
10.8.14 Rinse chamber......................................................................................................................... 10-39
10.8.14.1Adapter with rinse chamber...................................................................................... 10-39
10.8.14.2Reed switch.............................................................................................................. 10-39
10.8.15 bibag®connector ..................................................................................................................... 10-40
10.8.15.1bibag®connector complete ...................................................................................... 10-40
10.8.15.2Microswitch............................................................................................................... 10-41
10.8.16 Filter holder for DIASAFE®plus .............................................................................................. 10-41
10.9 Extracorporeal Blood Circuit Module (EBM)....................................................................... 10-42
10.9.1 Opening and closing the EBM, service position ...................................................................... 10-42
10.9.2 Pneumatic unit contamination.................................................................................................. 10-43
10.9.3 BPM (option)............................................................................................................................ 10-44

Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13 ix
10.9.4 Luer-Lock connection cone ..................................................................................................... 10-44
10.9.5 Blood pump ............................................................................................................................. 10-45
10.9.5.1 Stepper motor with gear........................................................................................... 10-45
10.9.5.2 P.C.B. LP 624 pump control..................................................................................... 10-45
10.9.5.3 Hall sensor for rotor.................................................................................................. 10-45
10.9.6 Heparin pump .......................................................................................................................... 10-46
10.9.6.1 P.C.B. LP 950 .......................................................................................................... 10-46
10.9.6.2 Optical sensor .......................................................................................................... 10-46
10.9.6.3 Drive......................................................................................................................... 10-47
10.9.6.4 Mechanics ................................................................................................................ 10-47
10.9.7 Drip chamber holder ................................................................................................................ 10-48
10.9.7.1 Drip chamber holder complete ................................................................................. 10-48
10.9.7.2 Ultrasonic sensors.................................................................................................... 10-48
10.9.8 Compressor / ventilation valve ................................................................................................ 10-49
10.9.9 Venous occlusion clamp with rotary magnet, bolt ................................................................... 10-50
10.10 Calibration and test steps after repair................................................................................. 10-51
11 Functional description
11.1 Functional description ............................................................................................................ 11-1
11.1.1 T1 test description ..................................................................................................................... 11-1
11.1.1.2 T1 test flow diagram, parallel run ............................................................................... 11-3
11.1.1.3 Overview of the individual test sections ..................................................................... 11-4
11.1.1.6 Blood system test.......................................................................................................11-7
11.1.1.7 Venous pressure system test..................................................................................... 11-8
11.1.1.10Arterial pressure system test.................................................................................... 11-11
11.1.1.16UF function test ........................................................................................................ 11-17
11.1.2 Tests during cleaning programs .............................................................................................. 11-20
11.1.2.1 PSW (pressure switch) monitoring during free rinsing
(only with devices with CDS).................................................................................... 11-20
11.1.2.2 Rinse section test (check of V91, V99, V100) (only devices with CDS)................... 11-21
11.1.2.4 V39 Test................................................................................................................... 11-23
11.1.3 Description of the modules ...................................................................................................... 11-24
11.1.3.1 Arterial blood pump .................................................................................................. 11-24
11.1.3.2 Single-Needle blood pump (optional)....................................................................... 11-24
11.1.3.3 Heparin pump........................................................................................................... 11-25
11.1.3.4 Air Detector .............................................................................................................. 11-26
11.1.3.5 Optical Detector ....................................................................................................... 11-27
11.1.3.6 Venous pressure measurement ............................................................................... 11-27
11.1.4 Functional description of the hydraulic unit ............................................................................. 11-28
11.1.4.1 Hydraulic flow diagram............................................................................................. 11-28
11.1.4.2 Description of the hydraulic unit ............................................................................... 11-30
11.1.4.3 Functional principle of the balancing chamber......................................................... 11-32
11.1.4.4 CDS - Central Delivery System (option)................................................................... 11-35
11.2 Block diagrams / wiring diagrams / P.C.B. layouts ............................................................ 11-43
11.2.1 4008 S block diagram.............................................................................................................. 11-43
11.2.2 Voltage supply block diagram.................................................................................................. 11-44
11.2.3 Monitor block diagram ............................................................................................................. 11-45
11.2.4 HPU block diagram (hydraulic processing unit)....................................................................... 11-46
11.2.5 HPU wiring diagram (hydraulic processing unit)...................................................................... 11-47
11.2.6 CAN communication connection diagram ............................................................................... 11-49
11.2.7 P.C.B. LP 450-2 Air detector control (LD) ............................................................................... 11-50
11.2.8 P.C.B. LP 493 Blood leak detector .......................................................................................... 11-52

x Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13
11.2.9 P.C.B. LP 624 Pump control, arterial blood pump / Single-Needle blood pump (option) ........ 11-53
11.2.10 P.C.B. LP 630 Motherboard..................................................................................................... 11-54
11.2.11 P.C.B. LP 632 CPU 2 .............................................................................................................. 11-55
11.2.12 P.C.B. LP 633-5 Input board.................................................................................................... 11-57
11.2.13 P.C.B. LP 634 Output board.................................................................................................... 11-59
11.2.14 P.C.B. LP 636 External I/O board............................................................................................ 11-61
11.2.15 P.C.B. LP 645 membrane pump optical sensor....................................................................... 11-62
11.2.16 P.C.B. LP 763 Multi-interface board (COMMCO III) ................................................................ 11-63
11.2.17 P.C.B. LP 922 Display board ................................................................................................... 11-64
11.2.18 P.C.B. LP 941 HPU (hydraulic processing unit) ...................................................................... 11-65
11.2.19 P.C.B. LP 950 Control board (HEP) ........................................................................................ 11-66
11.2.20 P.C.B. LP 1131 Operation status indicator (traffic light) .......................................................... 11-67
11.2.21 P.C.B. LP 1147 BPM (optional) ............................................................................................... 11-68
11.2.22 P.C.B. LP 1627 Display, EBM SN (optional) ........................................................................... 11-69
11.2.23 P.C.B. LP 1628 Distributor board ............................................................................................ 11-70
11.2.24 P.C.B. LP 1629 EBM display ................................................................................................... 11-71
11.2.25 P.C.B. LP 1631 CPU 1 ............................................................................................................ 11-72
11.2.26 Heater board (4008 power supply unit) ................................................................................... 11-74
11.2.27 Power board (4008 power supply unit).................................................................................... 11-75
12 Appendix

Chapter 1: Index
Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13 1-1
1 Index
The source specifications in the index (e.g., 11-3) refer to the page identification in the footer. In this
example, the index entry can be found in chapter 11 on page 3.
Numerics
4008 S block diagram 11-43
A
Accessories and supplies 6-2
Alarm output (staff call) 4-14
Alarm override 4-15
Appendix 12-1
Audio paused 4-14
B
Balancing chamber loading
pressure 9-45
Balancing chamber, functional
principle 11-32
Battery 4-4
Battery fuse 4-4
Battery LP1631 4-4
Battery LP632 4-4
Battery maintenance 4-13
bibag® pressure transducer
(Envec), verification 9-50
Block diagrams / wiring diagrams
11-43
Blood leak override time 4-14
Blood pump (arterial) error
messages 7-34
Blood pump, removing 10-45
BPM (option), removing 10-44
C
CALIBRATION 5-63, 9-1
Calibration / adjustment 9-1
Calibration and test steps after
repair 10-51
CALIBRATION menu structure 9-2
CAN communication connection
diagram 11-49
CDS - Central Delivery System
(option) 11-35
CDS pressure switch 9-48
Change accumulator. 10-17
Changing the location in a
domestic environment 3-2
Checking the electrical safety 6-28
Cleaning programs (error
messages) 7-18
Cleaning programs, program runs
11-36
Component overview 10-3
Compressor / ventilation valve,
removing 10-49
D
Degassing pump pressure 9-43
Device error during cleaning
programs 7-18
DIAGNOSTICS 5-32
DIAGNOSTICS menu structure
5-34
Dimensions and weights 4-1
Display fields (1 to 4) 5-33
Domestic environment 3-2
Drip chamber, removing 10-48
E
EBM, opening and closing, service
position 10-42
Electrical safety 4-3
Electrical supply 4-4
Electromagnetic emissions 4-8
Electromagnetic immunity 4-8
Equipment 10-2
Error messages 7-1
Error messages after turning
power on 7-28
Error messages during dialysis
7-29
External connection options 4-13
F
Fixed location 3-2
Float switch, removing and
installing 10-26
Flow pump pressure 9-46
Front panel, completely removing
10-19
Functional description 11-1
Fuses 4-4
H
Heater block, removing and
installing 10-25
Heater board fuses 4-4
Heater rod, removing and
installing 10-27
Heparin pump error messages
7-34
Heparin pump, removing 10-46
Heparin pump, setting Hall
sensors 9-39
Home dialysis 3-2
Housing and cart 10-11
HPU (hydraulic processing unit)
error messages 7-32
HPU block diagram (hydraulic
processing unit) 11-46
HPU wiring diagram (hydraulic
processing unit) 11-47
Hydraulic flow diagram 11-28
Hydraulic processing unit
(assignment) 10-9
Hydraulic unit, completely
removing 10-23
Hydraulic unit, description 11-30
Hydraulics unit 9-42

Chapter 1: Index
1-2 Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13
I
Important information 2-1
Initial start-up report 3-2
Initial start-up report, explanations
3-6
Installation 3-1
L
Luer-Lock connection cone,
removing 10-44
M
MISCELLANEOUS 5-60
MISCELLANEOUS menu
structure 5-60
Monitor block diagram 11-45
Monitor, opening 10-17
Moving within a domestic
environment 3-2
Multifunction block, removing and
installing 10-30
N
Note, significance 2-2
O
Operating conditions 4-11
Operation status indicator (traffic
light) 10-22
Optical detector, adjusting 9-54
P
P.C.B. layouts 11-50
P.C.B. LP 1631: DIP switch (array
1) 5-64
P.C.B. LP 1631: DIP switch (array
2) 5-65
P.C.B. LP 1631: DIP switch (array
3) 5-66
P.C.B. LP 632: DIP switch (array
1) 5-68
P.C.B. LP 632: DIP switch (array
2) 5-69
P.C.B. LP 634: DIP switch (array
1) 5-70
Pneumatic unit contamination
10-43
Power board fuse 4-4
Power supply unit and battery
10-15
Precautions for working on the
device 2-2
Printed circuit boards, removing
and installing 10-18
R
Reduced water inlet pressure 9-42
S
Separation distances
(recommended) between the
device and RF telecommunication
devices 4-10
Service mode 5-1
Servicing / repair 10-1
Settings without menu display 9-1
Setup / service program 5-1
SETUP MENU 5-3
SETUP MENU - menu structure
5-3
SETUP MENU settings 5-29
Shunt interlock 10-13
Significance of the warnings 2-1
Specifications 4-1
Storage conditions 4-13
T
T1 Test 7-1
T1 test description 11-1
T1 test flow diagram, parallel run
11-3
T1 test flow diagram, serial run
11-2
T1 test, overview of the individual
test sections 11-4
Test report – TSC 6-32
Tilting the device 10-11
Tools (service equipment) 8-1
Traffic light (operation status
indicator) 10-22
Transportation of hemodialysis
unit 3-28
TSC - Important information for
TSC/maintenance procedures 6-1
TSC / MA, explanations on test
report 6-6
TSC / maintenance 6-1
TSC, explanations on test report
6-6
TSC/MA test report 6-2
Type label (identification of the
device) 4-2
U
UF pump volume 9-47
V
Venous occlusion clamp,
removing 10-50
Voltage supply block diagram
11-44
W
Warnings 2-3

Chapter 2: Important information
Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13 2-1
2 Important information
2.1 How to use the Service Manual
Purpose This document is intended for service technicians and is to be used for
first studies (to acquire a basic knowledge) and for reference purposes
(for TSC, maintenance and repair). The document, however, does not
replace the training courses offered by the manufacturer.
Identification The document can be identified by the following information on the title
page and on the labels, if any:
– Edition of the document
– Part number of the document
Footer The footer contains the following information:
– Company name, e.g., Fresenius Medical Care
– Device type
– The English abbreviation for the document type and the international
abbreviation for the document language, for example: OP-EN refers
to Operating Instructions in English.
– Edition, e.g., 4/03.11 means, 4th edition, March 2011
– The page identification 1-3, for example refers, to chapter 1, page 3.
Organization of the
chapters
To facilitate the use of documents from Fresenius Medical Care, the
organization of the chapters has been standardized in all manuals.
There may therefore be chapters within this document without any
content. Chapters without content are identified.
Illustrations The illustrations used in the documents may differ from the original if
this does not have any influence on the function.
Changes Changes to the document will be released as new editions or
supplements. In general: this manual is subject to change without
notice.
Reproduction Reproduction, even in part, is only permitted with written approval.
2.2 Significance of the warning
Warning
Advises the operator that failure to observe this information can result
in personal injury.

Chapter 2: Important information
2-2 Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13
2.3 Significance of the note
2.4 Precautions for working on the device
Requirements Knowledge of the current Operating Instructions of the respective
device. Background experience in mechanics, electrical and medical
engineering.
Authorized persons
Test equipment and
accessories
The activities described in the document require the availability of the
necessary technical measuring equipment and accessories.
Specifications The technical specifications must be adhered to.
Precautions Before turning power on, repair any visible damage.
Prior to opening the device and when working on the open device, the
following precautions have to be observed:
– Protect the components against ingress of liquids.
– Do not touch live parts.
– Disconnect and connect all jacks, connectors and components only
when the device is turned off.
ESD precautions When repairing the device and when replacing spare parts, observe the
applicable ESD precautions.
To be observed after
working on the device
A T1 test and a check of the electrical safety must be performed after
working on the device.
The current Operating Instructions must be enclosed with the device. If
necessary, additional operator training is required.
Note
Advises the operator that failure to observe this information can:
– cause damage to the equipment.
– result in a specific function not being executed at all or not being
executed correctly.
Warning
Commissioning steps, extensions, adjustments, calibrations,
maintenance measures, modifications or repairs may only be carried
out by the manufacturer or persons authorized by him.

Chapter 2: Important information
Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13 2-3
After work has been
completed
Spare parts Use only original spare parts.
For the identification and for ordering spare parts, test equipment and
tools, always use the electronic spare parts catalog.
2.5 Technical documentation
On request, circuit diagrams, descriptions and other documents are
made available by the manufacturer. These are intended to support
trained personnel of the responsible organization in servicing and
repairing the device.
2.6 Warnings
2.6.1 Warnings relating to hygiene
2.6.2 Warnings relating to electricity
Warning
When the device is returned to use, check that the pressure of the water
supply meets the prescribed minimum pressure.
Warning
Risk of infection
To protect the patient from infections, disinfect the device each time you
repaired or commissioned the device and each time you carried out
TSC or maintenance measures.
Always run a disinfection after having worked on the device in any way!
Warning
Risk of injury caused by electrical voltage.
Touching live parts will cause an electric shock.
Disconnect the power plug before opening the device. Actuating the
On / Off switch stops operation of the device, but does not
disconnect the device from the supply voltage!

Chapter 2: Important information
2-4 Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13
2.7 Addresses
Manufacturer Fresenius Medical Care AG & Co. KGaA
61346 Bad Homburg
Germany
Phone: [phone]
www.fmc-ag.com
International
service
Fresenius Medical Care
Deutschland GmbH
Service Support International
Hafenstrasse 9
97424 Schweinfurt
Germany
Phone: [phone] (hotline)
Fax: [phone]
Local service

Chapter 3: Installation
Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13 3-1
3Installation
3.1 Important initial start-up information
For initial start-up only The following information is intended only for the initial start-up. This
information is not applicable for recommissioning devices that have
been removed from service or have temporarily been taken out of
service.
Environmental conditions Variations in temperature during transport may cause condensation
leading to water developing on live parts. In the event of major
variations in temperature, allow sufficient time for the device to adjust to
the ambient temperature before start-up. When bringing the
hemodialysis device from a cooler into a warmer room, allow
approx. 2 hours for the device to adjust to the ambient temperature
before switching it on.
Tester's qualification The checks must only be carried out by persons, who, based on their
training, knowledge and on-hand experience, are qualified to carry out
such checks in a proper manner. Furthermore, the persons, who carry
out the checks, may not be subjected to outside instructions with
regards to these checks.
Test equipment and
accessories
The activities described in the document require the availability of the
necessary technical measuring equipment and accessories.
Specifications The technical specifications must be adhered to.
Precautions Before turning power on, repair any visible damage.
Prior to opening the device and when working on the open device, the
following precautions have to be observed:
– Protect the components against ingress of liquids.
– Do not touch live parts.
– Disconnect and connect all jacks, connectors and components only
when the device is turned off.
ESD precautions When repairing the device and when replacing spare parts, observe the
applicable ESD precautions.
TSC/ MA intervals The TSC/MA procedures on this device are to be performed after
24 months.
Warning
Commissioning steps, extensions, adjustments, calibrations,
maintenance measures, modifications or repairs may only be carried
out by the manufacturer or persons authorized by him.

Chapter 3: Installation
3-2 Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13
3.2 Important information for use in a domestic environment
Operation in a domestic
environment (home
dialysis) in accordance
with IEC 60601-1-11
If the hemodialysis device is to be used in a domestic environment
(home dialysis), then special requirements apply to the unit's electrical
power connection. Due to regulatory standards, an unambiguous mains
power socket must be used for the electrical power connection.
One suitable plug socket, for example, is a 3-pin IEC 60309-2 standard
mains power socket. Matching mains power cables for the hemodialysis
device are available on request.
The manufacturer points out that local laws take precedence over the
normative standards mentioned above.
Fixed location The location of the hemodialysis device is "fixed" by its connection to
the distinctive power socket (i.e. it is only ever connected to this socket).
Only one distinctive power socket may be set up on any one domestic
premises.
Changing the location in a
domestic environment
Where medical care is provided in a domestic environment (home
dialysis), the location of the hemodialysis device is fixed. If, following
this fixed-location installation, the hemodialysis device needs to be
moved to a different location, then the requirements must be met as
specified in this chapter.
Moving within a domestic
environment
(see Transportation of hemodialysis unit page 3-28)
3.3 Initial start-up report
See the following pages.
Warning
The power supply's protective conductor must comply with the
IEC 60364-7-710 standard. The following checks must also be made by
suitably-qualified personnel:
– Check the power supply's protective conductor circuit.

Chapter 3: Installation
Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13 3-3
4008 S (Version V10) Initial start-up report
Technician's name: Customer / customer no.:
Device type including option(s) /
Software version: Serial no.: Inventory no.:
Service report no.: Operating hours: Equipment code:
Device type including option(s): SN
BPM
ZKV
No. Description Operating
condition Corr. Meas. value 
1Preparation
1.1 Check and insert the battery fuse. Off ––
1.2 Remove the closing plugs:
heater block overflow tube, disinfectant connector, water inlet plate
Off ––
2Visual inspections
2.1 Labels and identifications are present and legible. Off ––
2.2 Mechanical condition permits safe use. No signs of damages or
contamination affecting correct function. Off ––
2.3 The power cable shows no signs of damage. Off ––
2.4 Emergency crank for blood pump attached to housing rear. Off ––
2.5 Color coding of the dialyzer couplings and of the shunt cover adapted to
customer specifications (counter-current principle). Off ––
State upon delivery:
Dialysate inlet port (right): Dialyzer coupling and shunt interlock = red
Dialysate outlet port (left): Dialyzer coupling and shunt interlock = blue
––
Dialysate inlet port (right): Dialyzer coupling and shunt interlock = blue
Dialysate outlet port (left): Dialyzer coupling and shunt interlock = red
––
3Preparation for operation
3.1 Water inlet tube and drain connected. Off ––
3.2 Connect the CDS tubing. Off ––
3.3 Check the DIP switch. Off ––
3.4 V91, V99, V100 are functional and tight:
(This test is not applicable if the CDS or the rinse section test is activated.)
Off ––
3.5 Rinse to remove any preservatives. Cleaning / rinsing ––
3.6 Connect the DIASAFE®plus filter
and run the "filter change" program.
Cleaning / filter
change ––
4Check of hydraulics
4.1 Water inlet pressure (reduced):
1.2 bar (+0.2 bar / –0.3 bar)
CALIBRATION Yes
No 
4.2 Loading pressure: 1.45 bar (±0.05 bar) CALIBRATION Yes
No 
4.3 Degassing pump negative pressure: 0.82 bar (±0.01 bar) CALIBRATION Yes
No 
4.4 Relief pressure of balancing chamber at 800 ml/min:
2.2 bar (±0.05 bar)
CALIBRATION Yes
No 
5Check of the zero point of the pressure display (art./ven.)
5.1 Arterial zero point: 0 mmHg (±10 mmHg) CALIBRATION Yes
No 
5.2 Venous zero point: 0 mmHg (±10 mmHg) CALIBRATION Yes
No 
6Check of the blood leak detector

Chapter 3: Installation
3-4 Fresenius Medical Care 4008 S (Version V10) SM-EN 7/01.13
6.1 Blood leak: Desired = 5 V (±0.2 V) CALIBRATION Yes
No 
6.2 Dimness: Desired = 5 V (±0.3 V) CALIBRATION Yes
No 
7Check of the dialysate pressure
7.1 Zero point checked (flow off). CALIBRATION ––
7.2 Slope checked. CALIBRATION ––
8SETUP SETTINGS (PC SERVICE PROGRAM)
8.1 Make Setup settings and transfer data to the hemodialysis device. CALIBRATION ––
8.2 Reset the failure record. CALIBRATION ––
8.3 Download setup and calibration data
(PC service program)
CALIBRATION ––
8.4 Print setup data. CALIBRATION ––
9Check of the extracorporeal components
9.1 Blood pumps: Check the blood pump rate.
(BP-Rate CHECK)
CALIBRATION ––
9.2 Single-Needle switching pressure checked according to table. CALIBRATION ––
10 Checking the electrical safety
According to (DIN) EN 62353:2008, IEC 62353:2007
10.1 Visual inspection performed. Off ––
10.2 Protective earth resistance measured.
Max. 0.3 (with power cable) Off –
10.3 Device leakage current measured.
Differential current measurement according to figure 5
or
Direct measurement according to fig. 4
Preparation ––
Nominal voltage of power supply: V ––
Device leakage current mains polarity 1: A––
for line voltage: V ––
Scaled to nominal voltage
(maximum 500 A, see Additional requirements) –A
Device leakage current mains polarity 2: A––
for line voltage: V ––
Scaled to nominal voltage
(maximum 500 A, see Additional requirements) –A
11 Functional test
11.1 T1 test performed. T1 Test ––
11.2 Blood pump stop alarm checked. Preparation ––
11.3 Venous occlusion clamp closes after blood alarm. Preparation ––
11.4 Pressure of approx. 2 bar in the venous bubble catcher:
Pressure may not drop by more than 0.1 bar within 3 minutes.
Preparation ––
12 Check of the conductivity
(Connect the bibag®)
12.1 Conductivity of reference device (in mS/cm) Preparation Yes
No 
12.2 Conductivity of hemodialysis device display:
desired = reference device conductivity (±0.2 mS/cm)
Preparation Yes
No 
13 Check of the temperature
13.1 Reference device temperature:
Desired = 36.5°C (±0.2°C)
Dialysis Yes
No °C 
14 Final check
14.1 Power failure alarm – continuous sound – text displayed: Power Failure Preparation ––
14.2 Air separation: Activating the air separation pump.
Text display with further air separation and blood detected
(optical detector dark): Fill program
Preparation ––
14.3 Run the disinfection program. Cleaning /
disinfection ––
14.4 Operating Instructions and accessories package complete and match the
device. Off ––
14.5 Attach TSC inspection label. Off ––
No. Description Operating
condition Corr. Meas. value 