4008 s Imagine

FreseniusMedicalCareSM-EN

4008 SHemodialysis device

Service Manual

Software version: 10.4 and higherEdition: 1/05.09

Part no.: M43 753 10123

Table of contents

1 Index

2 Important information2.1 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 Technician's qualification......................................................................................................... 2-2

2.5 Precautions for working on the device ................................................................................... 2-2

2.6 Technical documentation ......................................................................................................... 2-3

2.7 Warnings .................................................................................................................................... 2-32.7.1 Electrical hazards ........................................................................................................................ 2-32.7.2 Biological hazards ....................................................................................................................... 2-3

2.8 Addresses .................................................................................................................................. 2-5

3 Installation3.1 Initial start-up ............................................................................................................................. 3-13.1.1 Important initial start-up information ............................................................................................ 3-1

3.2 Initial start-up report ................................................................................................................. 3-2

3.3 Explanations for the initial start-up report .............................................................................. 3-7

3.4 Decommissioning / removal from service / recommissioning............................................ 3-203.4.1 Decommissioning ...................................................................................................................... 3-203.4.2 Removal from service................................................................................................................ 3-203.4.3 Recommissioning ...................................................................................................................... 3-20

4 Specifications4.1 Dimensions and weight ............................................................................................................ 4-1

4.2 Type label (identification of the device) .................................................................................. 4-1

4.3 Electrical safety ......................................................................................................................... 4-2

4.4 Electrical supply ........................................................................................................................ 4-2

4.5 Fuses .......................................................................................................................................... 4-2

4.6 Guidance and manufacturers declaration for EMC (IEC 60601-1-2:2001) ........................... 4-3

4.7 Operating conditions ................................................................................................................ 4-6

4.8 Storage conditions .................................................................................................................... 4-6Fresenius Medical Care 4008 S SM-EN 1/05.09 iii

4.9 External connection options .................................................................................................... 4-7

4.10 Override conditions................................................................................................................... 4-7

4.11 Materials used............................................................................................................................ 4-8

5 Setup / service program5.1 Calibration mode ....................................................................................................................... 5-15.1.1 Calibration mode overview .......................................................................................................... 5-15.1.2 Calibration mode key functions.................................................................................................... 5-25.1.3 SETUP MENU ............................................................................................................................. 5-3

5.1.3.1 SETUP MENU - menu structure................................................................................... 5-35.1.3.2 Part 1: Setting alarm and warning times ...................................................................... 5-45.1.3.3 Part 2: Setting the cleaning program............................................................................ 5-75.1.3.4 Part 3: Mixing ratio ..................................................................................................... 5-125.1.3.5 Part 4: Setting the conductivity limit ........................................................................... 5-165.1.3.6 Part 5: Cleaning program info sound.......................................................................... 5-165.1.3.7 Part 6: Setting dialysis parameters............................................................................. 5-175.1.3.8 Part 7: Cumulated blood volume ................................................................................ 5-205.1.3.9 Part 8: OCM settings .................................................................................................. 5-215.1.3.10 Part 9: Automatically starting Single-Needle mode .................................................... 5-235.1.3.11 Part 10: Activating Monit_NTC 109 ............................................................................ 5-235.1.3.12 Part 11: UF settings.................................................................................................... 5-235.1.3.13 Part 12: Setting the priming time ................................................................................ 5-245.1.3.14 Part 13: Sound I/O switch........................................................................................... 5-245.1.3.15 Part 14: Activating the key click.................................................................................. 5-245.1.3.16 Part 15: Setting the BPR/UFR warning ...................................................................... 5-245.1.3.17 Part 16: Setting the rinse volume ............................................................................... 5-255.1.3.18 Part 17: T1 test autostart ............................................................................................ 5-255.1.3.19 Part 18: Setting the venous alarm window ................................................................. 5-255.1.3.20 Part 19: Setting central delivery ................................................................................. 5-265.1.3.21 Part 20: AutoOFF after AutoON ................................................................................. 5-265.1.3.22 Part 21: CAMUS baud rate......................................................................................... 5-265.1.3.23 Part 22: BPM settings (optional)................................................................................. 5-275.1.3.24 Part 23: Storing default values ................................................................................... 5-315.1.3.25 SETUP MENU settings .............................................................................................. 5-32

5.1.4 DIAGNOSTICS.......................................................................................................................... 5-345.1.4.1 DIAGNOSTICS, general information.......................................................................... 5-345.1.4.2 DIAGNOSTICS menu structure.................................................................................. 5-365.1.4.3 Reading the analog inputs of CPU I ........................................................................... 5-385.1.4.4 Reading the analog inputs of CPU II .......................................................................... 5-405.1.4.5 Reading the digital inputs of CPU I ............................................................................ 5-415.1.4.6 Reading the digital inputs of CPU II ........................................................................... 5-465.1.4.7 Setting the analog outputs of CPU I ........................................................................... 5-495.1.4.8 Setting the analog outputs of CPU II .......................................................................... 5-505.1.4.9 Setting the digital outputs of CPU I ............................................................................ 5-515.1.4.10 Setting the digital outputs of CPU II ........................................................................... 5-565.1.4.11 Setting/reading the digital outputs of CPU I ............................................................... 5-595.1.4.12 HPU (hydraulic processing unit) ................................................................................. 5-605.1.4.13 BPM (option) .............................................................................................................. 5-61

5.1.5 MISCELLANEOUS .................................................................................................................... 5-625.1.5.1 MISCELLANEOUS menu structure............................................................................ 5-625.1.5.2 System clock .............................................................................................................. 5-635.1.5.3 SW-VERSION-NUMBER ........................................................................................... 5-63iv Fresenius Medical Care 4008 S SM-EN 1/05.09

5.1.5.4 BPM (option) .............................................................................................................. 5-645.1.6 CALIBRATION........................................................................................................................... 5-65

5.2 DIP switch overview ................................................................................................................ 5-665.2.1 P.C.B. LP 631 (CPU 1) DIP switch array 1................................................................................ 5-665.2.2 P.C.B. LP 631 (CPU 1) DIP switch array 2................................................................................ 5-675.2.3 P.C.B. LP 632 (CPU 2) DIP switch array 1................................................................................ 5-685.2.4 P.C.B. LP 632 (CPU 2) DIP switch array 2................................................................................ 5-69

6 TSC / maintenance6.1 Important information ............................................................................................................... 6-1

6.2 Accessories and supplies ........................................................................................................ 6-2

6.3 TSC / MA test report ................................................................................................................. 6-3

6.4 Explanations for the test report - TSC / MA .......................................................................... 6-11

6.5 Test report - TSC ..................................................................................................................... 6-23

7 Error messages7.0.1 T1 test.......................................................................................................................................... 7-1

7.0.1.1 Prerequisites for starting and running the test.............................................................. 7-17.0.1.2 Bypass test................................................................................................................... 7-17.0.1.3 Optical detector test ..................................................................................................... 7-27.0.1.4 Blood system test ......................................................................................................... 7-37.0.1.5 Venous pressure system test ....................................................................................... 7-57.0.1.6 Air detector test ............................................................................................................ 7-67.0.1.7 Display test................................................................................................................... 7-87.0.1.8 Arterial pressure system test........................................................................................ 7-87.0.1.9 Battery test ................................................................................................................... 7-87.0.1.10 Blood leak test.............................................................................................................. 7-97.0.1.11 Temperature test ........................................................................................................ 7-107.0.1.12 Negative pressure holding test................................................................................... 7-117.0.1.13 Positive pressure holding test .................................................................................... 7-127.0.1.14 UF function test .......................................................................................................... 7-157.0.1.15 Conductivity test ......................................................................................................... 7-167.0.1.16 Diasafe filter test ........................................................................................................ 7-177.0.1.17 Diasafe plus filter test ................................................................................................. 7-18

7.0.2 Description of device errors during the cleaning programs ....................................................... 7-207.0.2.1 V84 monitoring ........................................................................................................... 7-207.0.2.2 PSW (pressure switch) monitoring during free rinsing (only with devices with CDS). 7-217.0.2.3 Rinse section test (check of V91, V99, V100) (only devices with CDS)..................... 7-237.0.2.4 Rinse section test (check of V91 and valve 98) (only devices without CDS) ............. 7-247.0.2.5 Rinse section test (check of V91, V99, V100, V120) (only devices with BIBAG and without

CDS) .......................................................................................................................... 7-257.0.2.6 V39 test ...................................................................................................................... 7-267.0.2.7 Further messages which may be displayed before or during a cleaning program..... 7-27

7.0.3 Error messages after turning power on ..................................................................................... 7-307.0.4 Error messages during dialysis ................................................................................................. 7-31

7.0.4.1 HPU (hydraulic processing unit) errors ...................................................................... 7-347.0.4.2 Blood pump (arterial).................................................................................................. 7-36Fresenius Medical Care 4008 S SM-EN 1/05.09 v

7.0.4.3 Heparin pump............................................................................................................. 7-36

8 Tools (service equipment)

9 Calibration / adjustment9.1 CALIBRATION ............................................................................................................................ 9-19.1.1 Settings without menu display ..................................................................................................... 9-19.1.2 CALIBRATION menu structure.................................................................................................... 9-29.1.3 Part 1: Calibrating the arterial pressure ....................................................................................... 9-49.1.4 Part 2: Calibrating the pressure in the arterial blood pump ......................................................... 9-59.1.5 Without menu display: Setting the blood pump stop alarm.......................................................... 9-69.1.6 Part 3: Calibrating the venous pressure ...................................................................................... 9-69.1.7 Part 4: Calibrating the venous pressure measurement in the air detector................................... 9-79.1.8 Part 5: Calibrating the blood pump rates ..................................................................................... 9-89.1.9 Part 5.1: Calibrating the arterial blood pump rate ........................................................................ 9-89.1.10 Part 5.2: Calibrating the SN blood pump rate (option)................................................................. 9-99.1.11 Without menu display: Calibrating the Single-Needle blood pump (SN pressure) (optional) .... 9-109.1.12 Part 6: Measuring the volume of the UF pump in liters.............................................................. 9-119.1.13 Part 7: Calibrating the degassing pressure................................................................................ 9-129.1.14 Part 8: Calibrating the 300 flow rate .......................................................................................... 9-129.1.15 Without menu display: Adjusting the current increasing pulse .................................................. 9-139.1.16 Alternative method of adjusting the current increase (if an oscilloscope is not available) ......... 9-139.1.17 Part 9: Calibrating the 500 flow rate .......................................................................................... 9-149.1.18 Part 10: Calibrating the 800 flow rate ........................................................................................ 9-149.1.19 Part 11: Calibrating the dialysate temperature .......................................................................... 9-159.1.20 Part 11.1: Setting the dialysate temperature ............................................................................. 9-169.1.21 Part 11.2: Calibrating the dialysate temperature ....................................................................... 9-179.1.22 Part 11.3: Testing the dialysate temperature for OCM .............................................................. 9-189.1.23 Part 12: Calibrating the mixing system ...................................................................................... 9-199.1.24 Part 12.1: Running in the membrane pumps ............................................................................. 9-199.1.25 Part 12.2: Determining the balancing chamber volume............................................................. 9-209.1.26 Part 12.3: Calibrating the concentrate pump stroke .................................................................. 9-209.1.27 Part 12.4: Measuring the volume of the concentrate pump in liters........................................... 9-219.1.28 Part 12.5: Calibrating the bicarbonate pump stroke .................................................................. 9-229.1.29 Part 12.6: Measuring the volume of the bicarbonate pump in liters........................................... 9-239.1.30 Part 12.7: Testing the concentrate and bicarbonate volumes ................................................... 9-249.1.31 Part 13: Calibrating the conductivity .......................................................................................... 9-259.1.32 Part 13.1: Setting the conductivity ............................................................................................. 9-269.1.33 Part 13.2: Setting the temperature / conductivity compensation ............................................... 9-279.1.34 Part 13.3: Calibrating the OCM pulse ........................................................................................ 9-289.1.35 Part 13.4: Checking the conductivity ......................................................................................... 9-299.1.36 Part 13.5: Checking the OCM conductivity ................................................................................ 9-309.1.37 Part 13.6: Testing the temperature / conductivity compensation............................................... 9-319.1.38 Part 14: Calibrating the dialysate pressure................................................................................ 9-329.1.39 Part 14.1: Dialysate pressure .................................................................................................... 9-339.1.40 Part 14.2: TMP test.................................................................................................................... 9-349.1.41 Part 14.3: PDIAL2 press-check ................................................................................................. 9-359.1.42 Part 15: Blood leak voltage........................................................................................................ 9-369.1.43 Part 16: Calibrating the BIBAG values....................................................................................... 9-379.1.44 Part 17: Resetting the failure record .......................................................................................... 9-37vi Fresenius Medical Care 4008 S SM-EN 1/05.09

9.1.45 Part 18: Initializing the NOVRAM, clearing the mandatory rinse, erasing a V84 malfunction ... 9-389.1.46 Without menu display: Setting the Hall sensor in the heparin pump ......................................... 9-38

9.2 Hydraulics ................................................................................................................................ 9-409.2.1 Reduced water inlet pressure.................................................................................................... 9-409.2.2 Degassing pump pressure......................................................................................................... 9-419.2.3 Balancing chamber loading pressure ........................................................................................ 9-429.2.4 Flow pump pressure .................................................................................................................. 9-439.2.5 UF pump volume ....................................................................................................................... 9-439.2.6 CDS (central delivery system) pressure switch ......................................................................... 9-459.2.7 Verification of the bibag pressure transducer (Envec)............................................................. 9-47

9.3 Air detector .............................................................................................................................. 9-489.3.1 Calibration of air detector LD 22................................................................................................ 9-49

9.3.1.1 Adjustment using the set for air detector calibration (see adjustment instructions no. M36 067 1) ................................................................................................................. 9-50

9.3.1.2 Adjustment without the set for air detector calibration................................................ 9-519.3.1.3 Checking the venous occlusion clamp ....................................................................... 9-519.3.1.4 Adjusting the optical detector ..................................................................................... 9-51

10 Servicing / repair10.1 Precautions for working on the hemodialysis device.......................................................... 10-1

10.2 Equipment ................................................................................................................................ 10-2

10.3 Component overview .............................................................................................................. 10-310.3.1 Monitor....................................................................................................................................... 10-310.3.2 Extracorporeal Blood Circuit Module (EBM).............................................................................. 10-410.3.3 Hydraulics rear .......................................................................................................................... 10-510.3.4 Hydraulics, lateral view from the left .......................................................................................... 10-610.3.5 Hydraulics, lateral view from the right........................................................................................ 10-710.3.6 Hydraulics legend ...................................................................................................................... 10-8

10.4 Assembly of components ..................................................................................................... 10-1010.4.1 Self-cutting screws .................................................................................................................. 10-1010.4.2 Torques ................................................................................................................................... 10-10

10.5 Housing and cart ................................................................................................................... 10-1110.5.1 Tilting the device...................................................................................................................... 10-1110.5.2 Brake rollers ............................................................................................................................ 10-1110.5.3 Brakes ..................................................................................................................................... 10-1210.5.4 Shunt interlock......................................................................................................................... 10-13

10.5.4.1 Shunt interlock complete .......................................................................................... 10-1310.5.4.2 Microswitch............................................................................................................... 10-14

10.6 Power supply unit and battery ............................................................................................. 10-1510.6.1 Removing the power cable ...................................................................................................... 10-1510.6.2 Power supply unit .................................................................................................................... 10-15

10.6.2.1 Power board ............................................................................................................. 10-1610.6.2.2 Heater board ............................................................................................................ 10-16

10.6.3 Battery ..................................................................................................................................... 10-17

10.7 Monitor ................................................................................................................................... 10-1710.7.1 Opening the monitor ................................................................................................................ 10-1710.7.2 Removing and installing the printed circuit boards .................................................................. 10-1810.7.3 P.C.B. LP 630 Motherboard .................................................................................................... 10-1810.7.4 Replace the snap-hat battery on CPU2................................................................................... 10-18Fresenius Medical Care 4008 S SM-EN 1/05.09 vii

10.7.5 P.C.B. LP 636 External I/O board............................................................................................ 10-1910.7.6 Display ..................................................................................................................................... 10-19

10.7.6.1 Removing the complete front panel.......................................................................... 10-1910.7.6.2 P.C.B. LP 922........................................................................................................... 10-2010.7.6.3 MDC board and backlight inverter ............................................................................ 10-2010.7.6.4 TFT display............................................................................................................... 10-2110.7.6.5 Backlighting .............................................................................................................. 10-21

10.7.7 Status indicators ...................................................................................................................... 10-22

10.8 Hydraulics unit....................................................................................................................... 10-2310.8.1 Removing the complete hydraulics unit ................................................................................... 10-2310.8.2 P.C.B. LP 941 HPU with distribution bar ................................................................................. 10-2410.8.3 Heater block and heater rod .................................................................................................... 10-24

10.8.3.1 Heater block complete.............................................................................................. 10-2410.8.3.2 Float switch .............................................................................................................. 10-2610.8.3.3 Heater rod ................................................................................................................ 10-26

10.8.4 Multifunction block ................................................................................................................... 10-2710.8.5 Balancing chamber .................................................................................................................. 10-2810.8.6 Heat exchanger ....................................................................................................................... 10-2810.8.7 UF pump.................................................................................................................................. 10-2910.8.8 Membrane pump (Conc/Bic).................................................................................................... 10-3010.8.9 Gear pump............................................................................................................................... 10-31

10.8.9.1 Pump ........................................................................................................................ 10-3110.8.9.2 Motor ........................................................................................................................ 10-31

10.8.10 Blood leak detector .................................................................................................................. 10-3210.8.11 Valves (type)............................................................................................................................ 10-3310.8.12 Disinfection valve V84 with CD monitor................................................................................... 10-3410.8.13 Suction rod............................................................................................................................... 10-35

10.8.13.1Suction rod / rivet / sealing plunger .......................................................................... 10-3510.8.14 Rinse chamber......................................................................................................................... 10-36

10.8.14.1Adapter with rinse chamber...................................................................................... 10-3610.8.14.2Reed switch.............................................................................................................. 10-36

10.8.15 bibag connector ..................................................................................................................... 10-3710.8.15.1bibag connector complete ...................................................................................... 10-3710.8.15.2Microswitch............................................................................................................... 10-38

10.8.16 Filter holder for DIASAFE plus .............................................................................................. 10-38

10.9 Extracorporeal Blood Circuit Module EBM ......................................................................... 10-3910.9.1 Opening and closing the EBM, service position ...................................................................... 10-3910.9.2 Pneumatic unit contamination.................................................................................................. 10-4010.9.3 BPM (option)............................................................................................................................ 10-4110.9.4 Luer lock connection cone....................................................................................................... 10-4110.9.5 Blood pump.............................................................................................................................. 10-41

10.9.5.1 Stepper motor with gear ........................................................................................... 10-4110.9.5.2 Hall sensor for rotor.................................................................................................. 10-42

10.9.6 Heparin pump .......................................................................................................................... 10-4210.9.6.1 P.C.B. LP 950........................................................................................................... 10-4210.9.6.2 Optical sensor .......................................................................................................... 10-4310.9.6.3 Drive ......................................................................................................................... 10-4310.9.6.4 Mechanics ................................................................................................................ 10-43

10.9.7 Drip chamber holder ................................................................................................................ 10-4410.9.7.1 Drip chamber holder complete ................................................................................. 10-4410.9.7.2 Ultrasonic sensors.................................................................................................... 10-45

10.9.8 Compressor / ventilation valve................................................................................................. 10-4510.9.9 Occlusion clamp with rotary magnet, bolt ................................................................................ 10-46

10.10 Calibration and test steps after repair ................................................................................. 10-47viii Fresenius Medical Care 4008 S SM-EN 1/05.09

11 Functional description11.1 Description of the procedure ................................................................................................. 11-111.1.1 Flow diagrams ........................................................................................................................... 11-1

11.1.1.1 Hydraulic flow diagram............................................................................................... 11-1

11.2 Description of the device function and error description ................................................... 11-311.2.1 T1 test description ..................................................................................................................... 11-3

11.2.1.1 T1 test flow diagram, serial run .................................................................................. 11-411.2.1.2 T1 test flow diagram, parallel run ............................................................................... 11-511.2.1.3 T1 test description...................................................................................................... 11-611.2.1.4 Overview of the individual test sections ..................................................................... 11-611.2.1.5 Bypass test................................................................................................................. 11-711.2.1.6 Optical detector test ................................................................................................... 11-811.2.1.7 Blood system test ....................................................................................................... 11-911.2.1.8 Venous pressure system test ................................................................................... 11-1011.2.1.9 Air detector test ........................................................................................................ 11-1111.2.1.10Display test............................................................................................................... 11-1211.2.1.11Testing the arterial pressure system ........................................................................ 11-1311.2.1.12Battery test ............................................................................................................... 11-1411.2.1.13Blood leak test.......................................................................................................... 11-1511.2.1.14Temperature test ...................................................................................................... 11-1611.2.1.15Negative pressure holding test................................................................................. 11-1711.2.1.16Positive pressure holding test .................................................................................. 11-1811.2.1.17UF function test ........................................................................................................ 11-1911.2.1.18Conductivity test ....................................................................................................... 11-2011.2.1.19Testing the DIASAFE plus filter.............................................................................. 11-2111.2.1.20PSW (pressure switch) monitoring during free rinsing (only with devices with CDS)... 11-

2111.2.1.21Rinse section test (check of V91, V99, V100) (only devices with CDS)................... 11-2211.2.1.22Rinse section test (check of V91, V99, V100, V130) (only devices without CDS) ... 11-2311.2.1.23V39 test .................................................................................................................... 11-2411.2.1.24Blood pump (arterial)................................................................................................ 11-2511.2.1.25Single-Needle blood pump (option).......................................................................... 11-2511.2.1.26Heparin pump........................................................................................................... 11-2611.2.1.27Air detector ............................................................................................................... 11-2611.2.1.28Ultrasonic air detector .............................................................................................. 11-2711.2.1.29Optical detector ........................................................................................................ 11-2711.2.1.30Venous pressure measurement ............................................................................... 11-27

11.2.2 Functional description of the hydraulic unit ............................................................................. 11-2811.2.2.1 Description of the hydraulic unit ............................................................................... 11-3011.2.2.2 Functional principle of the balancing chamber ......................................................... 11-3211.2.2.3 CDS - Central Delivery System (option)................................................................... 11-3511.2.2.4 Program runs in cleaning programs ......................................................................... 11-36

11.3 Block diagrams / wiring diagrams / P.C.B. layouts ............................................................ 11-4511.3.1 4008 S block diagram.............................................................................................................. 11-4611.3.2 Voltage supply block diagram.................................................................................................. 11-4711.3.3 Monitor block diagram ............................................................................................................. 11-4811.3.4 HPU block diagram (hydraulic processing unit)....................................................................... 11-4911.3.5 HPU wiring diagram (hydraulic processing unit)...................................................................... 11-50

11.3.5.1 Legend for HPU wiring diagram (hydraulic processing unit) .................................... 11-5111.3.6 CAN communication connection diagram ............................................................................... 11-5211.3.7 P.C.B. LP 450-2 Air detector control (LD) ............................................................................... 11-5311.3.8 P.C.B. LP 493 Blood leak detector .......................................................................................... 11-5511.3.9 P.C.B. LP 624 Pump control

Arterial BP / Single-Needle BP (option)................................................................................... 11-56Fresenius Medical Care 4008 S SM-EN 1/05.09 ix

11.3.10 P.C.B. LP 630 Motherboard..................................................................................................... 11-5711.3.11 P.C.B. LP 631 CPU 1 .............................................................................................................. 11-5811.3.12 P.C.B. LP 632 CPU 2 .............................................................................................................. 11-6011.3.13 P.C.B. LP 633-5 Input board.................................................................................................... 11-6211.3.14 P.C.B. LP 634 Output board .................................................................................................... 11-6411.3.15 P.C.B. LP 636 External I/O board............................................................................................ 11-6611.3.16 P.C.B. LP 645 Membrane pump optical sensor....................................................................... 11-6711.3.17 P.C.B. LP 763 Multi-interface board (COMMCO III) ................................................................ 11-6811.3.18 P.C.B. LP 922 Display board ................................................................................................... 11-6911.3.19 P.C.B. LP 941 HPU (hydraulic processing unit) ...................................................................... 11-7011.3.20 P.C.B. LP 950 Control board (HEP) ........................................................................................ 11-7111.3.21 P.C.B. LP 1131 Status indicators ............................................................................................ 11-7211.3.22 P.C.B. LP 1147 BPM (optional) ............................................................................................... 11-7311.3.23 P.C.B. LP 1627 Display , EBM SN (optional) .......................................................................... 11-7411.3.24 P.C.B. LP 1628 Distributor board ............................................................................................ 11-7511.3.25 P.C.B. LP 1629 EBM display ................................................................................................... 11-7611.3.26 Heater board (4008 power supply unit) ................................................................................... 11-7711.3.27 Power board (4008 power supply unit) .................................................................................... 11-78

12 Appendixx Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 1: Index1 Index

AAlarm output (nurse call) 4-7Alarm override 4-7Alarm, audible alarm suppression 4-7Appendix 12-1

BBattery 4-6

CCalibration / adjustment 8-1, 9-1

EError messages 7-1Explanations on the initial start-up report 3-7

FFunctional description 11-1

IImportant information 2-1Installation 3-1

SServicing / repair 10-1Setup / Service program 5-1Specifications 4-1

TTSC / TMC / Maintenance 6-1Fresenius Medical Care 4008 S SM-EN 1/05.09 1-1

Chapter 1: Index1-2 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 2: Important information2 Important information

2.1 How to use the Service Manual

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

Page identification The page identification 1-3, for example, refers to: chapter 1, page 3.

Editorial information The editorial information 1/05.09, for example, refers to: 1st edition, May 2009.

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 (e.g. screens, photos, etc.) may differ from the original if this does not have any influence on the function.

Changes Changes to the technical document will be released as new editions or supplements. In general: this manual is subject to change without notice.

Reproduction Reproduction, even in parts, only with written approval.

2.2 Significance of the warning

Caution

Advises the operator against certain procedures or actions that could cause damage to the equipment or may have adverse effects on individuals.Fresenius Medical Care 4008 S SM-EN 1/05.09 2-1

Chapter 2: Important information2.3 Significance of the note

2.4 Technician's qualification

Purpose This technical 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 technical document, however, does not replace the training courses offered by the manufacturer.

Requirements Knowledge of the current Operating Instructions of the respective device.Background experience in mechanics, electrical and medical engineering.

2.5 Precautions for working on the device

Authorized persons Assembly, extensions, adjustments, modifications or repairs may only be carried out by the manufacturer or persons authorized by him.

Test equipment and accessories

The activities described in the technical 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 taken: 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.

Note

Informs the operator that failure to follow the steps as specified may result in the specific function not being executed correctly, not being executed at all, or not producing the desired effect.2-2 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 2: Important informationAfter work has been completed

When the device is returned to use, check that the pressure of the water supply meets the prescribed minimum pressure.

2.6 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.

2.7 Warnings

2.7.1 Electrical hazards

2.7.2 Biological hazards

Caution

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!

Caution

Risk of infection

There is always a possibility that the processed sample material and the waste bag are infectious. They must therefore always be treated as being potentially infectious.

Observe your local laws and regulations concerning handling of potentially infectious material.

Wear surgical or equivalent gloves when removing and processing the samples and when handling the cartridge.

Never bend the needle used for collecting the blood and do not put it back into its protective cap.

Use a new capillary/syringe for each measurement.Fresenius Medical Care 4008 S SM-EN 1/05.09 2-3

Chapter 2: Important informationCaution

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!2-4 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 2: Important information2.8 Addresses

Please address any inquiries to:

Manufacturer Fresenius Medical Care AG & Co. KGaA61346 Bad HomburgGermanyPhone: +49 (0)6172 609-0www.fmc-ag.com

Internationalservice

Fresenius Medical CareDeutschland GmbHService Support InternationalHafenstrae 997424 SchweinfurtGermanyPhone: +49 (0)9721 678-333 (hotline)Fax: +49 (0)9721 678-130

LocalserviceFresenius Medical Care 4008 S SM-EN 1/05.09 2-5

Chapter 2: Important information2-6 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 3: Installation3 Installation

3.1 Initial start-up

3.1.1 Important initial start-up information

For initial start-up only The initial start-up report is only intended for an initial start-up. It is not intended 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 initial start-up must be performed by the Technical Service of Fresenius Medical Care or a person authorized by them.

The initial start-up procedure may only be performed by persons qualified to properly perform the specified checks owing to their educational background and training, and knowledge and experience gained in practice. 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 this technical document require the availability of the necessary technical test 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 2 years (24 months).Fresenius Medical Care 4008 S SM-EN 1/05.09 3-1

Chapter 3: Installation3.2 Initial start-up report

See the following pages.3-2 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 3: Installation4008 S Initial start-up report

The checks below may only be carried out on a 4008 S device featuring software 10.0 if the device is started up for the first time (initial start-up).

Technician's name: Customer/Customer no.:

Device type with option(s) / software version:

Serial no.: Inventory no.:

Service report no.: Operating hours: Equipment code:

Device type including option(s): T SNT BPMT CDS

No. Description Oper. cond. Corr. Value 1 Preparation

1.1 Check and insert the battery fuse. Off T1.2 Labels and inscriptions are present and legible. Off T1.3 The mechanical condition permits further safe use. Off T1.4 There are no signs of damage or contamination. Off T1.5 The power cable shows no signs of damage. Off T1.6 Shunt interlock coding: Off

Inlet to the right = red; outlet to the left = blue (state on delivery) TInlet to the right = blue; outlet to the left = red T

1.7 Remove the closing plug from the heater block overflow tube, the disinfectant connector and the water inlet plate.

Off T

2 Preparing for operation

2.1 Connect the water supply and drain tubing. Off T2.2 Connect the CDS tubing. Off T2.3 Check the DIP switches. Off T2.4 V91, V99, V100 are functional and tight.

(This test is not applicable if the CDS or the rinse section test is activated.)

Off T

2.5 Rinse to remove any preservatives. Cleaning / rinsing T2.6 Connect the Diasafe filter.

Perform the "filter change" program.Cleaning /filter change

T

FreseniusMedicalCareFresenius Medical Care 4008 S SM-EN 1/05.09 3-3

Chapter 3: Installation2.7 Blood pump emergency crank attached to housing rear. Off T3 Checking the hydraulics

3.1 Water inlet pressure (reduced): 1.2 bar (+0.2 bar / 0.3 bar) CALIBRATION T YesT No ________

T

3.2 Loading pressure: 1.45 bar (0.05 bar) CALIBRATION T YesT No ________

T

3.3 Degassing pump negative pressure: 0.82 bar (0.01 bar) CALIBRATION T YesT No ________

T

3.4 Balancing chamber relief pressure at 800 ml/min:2.2 bar (0.05 bar)

CALIBRATION T YesT No ________

T

4 Checking the zero point of the pressure display (art./ven.)

4.1 Arterial zero point: 0 mmHg (10 mmHg) CALIBRATION T YesT No ________

T

4.2 Venous zero point: 0 mmHg (10 mmHg) CALIBRATION T YesT No ________

T

5 Checking the dialysate flow

5.1 Dialysate flow 800 ml/min (desired: 765 to 837 ml/min) CALIBRATION T YesT No ________

T


T


T

6 Checking the temperature

6.1 Reference device temperature: desired = 37 C (1 C) CALIBRATION T YesT No ________

T

6.2 Hemodialysis device temperature display: desired = 37 C (0.5 C)


T

7 Checking the conductivity(Connect the bibag)

7.1 Conductivity of reference device CALIBRATION T YesT No ________

T

7.2 Conductivity of hemodialysis device display:desired = reference device conductivity (0.2 mS/cm)


T

8 Checking the blood leak detector

8.1 Blood leak: desired = 5 V (0.2 V) CALIBRATION T YesT No ________

T

8.2 Dimness: desired = 5 V (0.3 V) CALIBRATION T YesT No ________

T

9 Checking the dialysate pressure

9.1 Zero point checked (flow off) CALIBRATION T9.2 Slope checked CALIBRATION T10 Checking extracorporeal components

10.1 Blood pumps: Check the blood pump rate.(calibration program: BP-Rate CHECK)

CALIBRATION T

10.2 SN switching pressure checked according to table(see Chapter 11.2.1.25 on page 11-25).

CALIBRATION T

10.3 Blood pump stop alarm checked. CALIBRATION T10.4 Venous line clamp closes after blood alarm. CALIBRATION T

No. Description Oper. cond. Corr. Value 3-4 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 3: Installation10.5 Pressure of approx. 2 bar in the venous bubble catcher.Pressure may not drop by more than 0.1 bar within 3 minutes.

CALIBRATION T

11 Setup settings (PC Service program)

11.1 Make Setup settings and transfer data to the dialysis device. CALIBRATION T11.2 Erase the error memory. CALIBRATION T11.3 Download setup and calibration data (Service program). CALIBRATION T11.4 Print setup data. CALIBRATION T12 Checking the electrical safety

According to (DIN) EN 62353: 2008, IEC 62353: 2007

12.1 Visual inspection performed according to item 1. Off T12.2 Protective earth resistance maximum 0.3 (with power cable) Off

________T

12.3 Measurement of the leakage current (device leakage current)

T Differential current measurement according to fig. 5orT Direct measurement according to fig. 4

Dialysis mode T

Nominal voltage of power supply: _______ V

Device leakage current mains polarity 1: _______ A

With line voltage: _______ V

Scaled to nominal voltage(max. 500 A, see also additional conditions)

Device leakage current mains polarity 2: _______ A

With line voltage: _______ V

Scaled to nominal voltage(max. 500 A, see also additional conditions)

13 Functional test

13.1 T1 test performed Dialysis mode T14 Final check

14.1 Power failure alarm continuous sound text displayed: Emergency operation

Dialysis mode T

14.2 Activation of air separation of degassing pump

Text display with further air separation and OD senses opaque:

Fill program

Dialysis mode T

14.3 Set temperature at desiredl = 37 C (36.8 to 37.2 C) Dialysis mode ________

T

14.4 Expected conductivity value Dialysis mode ________

T

14.5 Run the disinfection program. Cleaning /Disinfection

T

14.6 Make entries in the medical device register. Off T14.7 Operating Instructions and accessories package complete and

match the device.Off T

14.8 Attach TSC inspection label. Off T

No. Description Oper. cond. Corr. Value Fresenius Medical Care 4008 S SM-EN 1/05.09 3-5

Chapter 3: InstallationApplied measurement equipment:

Pressure (type, serial number):________________________________________________________________________________________

Protective earth resistance, leakage current (type, serial number):________________________________________________________________________________________

Remarks:

Date: Signature: Stamp:

The device has been released for further use.(Attach inspection label.)

T YesT No

Nextcheck:

Remarks:

Date: Signature: Stamp:

Caution

On completion of these procedures it is imperative to run a disinfection.3-6 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 3: Installation3.3 Explanations for the initial start-up report

Identification Technician's name:Surname and last name of technician.

Device type including option(s) / software version:Device name with possible options or extras. Software version, if available.

Service report number:Number of the service call.

Customer/customer no.:Number of the final customer.

Serial no.:Serial number indicated on the type label.

Inventory no.:Inventory number assigned to the device.

Operating hours:Operating hours, if a time meter is installed.

Equipment code:Equipment code indicated on the device.(e.g. EC xxx, E-code xxx)

Re 1 Preparation

Re 1.1 Check and insert the battery fuse.

Operating condition: Off

Re 1.2 Labels and inscriptions are present and legible.Check the following device specifications:

(8) serial number and (5) equipment code

Re 1.3 Mechanical condition permits further safe use.


Re 1.4 No damage or contaminations detectable.Fresenius Medical Care 4008 S SM-EN 1/05.09 3-7

Chapter 3: InstallationRe 1.5 The power cable shows no signs of damage.


Re 1.6 Shunt interlock coding:

Inlet to the right = red; outlet to the left = blue (state on delivery)

Inlet to the right = blue; outlet to the left = red


Re 1.7 Remove the closing plug from the heater block overflow tube, the disinfectant connector and the water inlet plate.

After rinsing out the anti-freeze, remove the closing plug from the overflow detection sleeve.


Re 2 Preparing for operation

Re 2.1 Connect the water supply and drain tubing.


Re 2.2 Connect the CDS tubings.

Operating condition: Off3-8 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 3: InstallationRe 2.3 Check the DIP switches.


The basic position on delivery is in italics. "No assignment" requires the "OFF" position.

P.C.B. LP 631 (CPU 1) DIP switch array 1

Note

The DIP switch 6 (SH 1) is provided for service purposes / trouble-shooting only and must be set to position OFF for dialysis mode.

DIP switch /position

Function

1ONOFFON OFF

2ONONOFF OFF

Maximum UF Rate1000 ml/h2000 ml/h3000 ml/h 4000 ml/h

3ONOFFONOFFONOFFONOFF

4ONONOFFOFFONONOFFOFF

5ONONONONOFFOFFOFFOFF

Language 1EnglishGermanFrenchPortugueseDutchItalianSwedishSpanish

Language 2EnglishFinnishCzechDanishRussianTurkishPolishSlovakian

Language 3EnglishJapaneseBulgarianGreekArabicNorwegianSlovenianSerbian

Language 4EnglishHungarian

6ONOFF

CRC/RAM testSkipGo

7ONOFF

Heater rod1300 W (at 100 to 120 V)1600 W (at 220 to 240 V)

8ONOFF

Test and cleaning flow500 ml/min800 ml/min

The basic position on delivery is in italics."No assignment" requires the "OFF" position.

SH21 2 3 4 5 6 7 8

ONOFF

SH1 LP631Fresenius Medical Care 4008 S SM-EN 1/05.09 3-9

Chapter 3: InstallationP.C.B. LP 631 (CPU 1) DIP switch array 2


Function

1ONOFF

CAL modeMode 0Mode 1

2ONOFFONOFF

3ONONOFFOFF

External alarm input Not validRO systemPatient bellExternal alarm

4ONOFF

Remote controlDevice with remote controlDevice without remote control

5ONOFF

COMMCO LP 763EnabledDisabled

6ONOFF

COMMCOSpecial protocolDefault protocol

7 *ONOFF

Rinse section test (exclusive CDS)ActiveNot active

8ONOFF

Central delivery systemInstalledNot installed


* DIP switch 7 is no longer relevant if DIP switch 8 is set to "ON".

1 2 3 4 5 6 7 8ON

OFF

SH2SH1 LP6313-10 Fresenius Medical Care 4008 S SM-EN 1/05.09


Caution

DIP switch 3 (SW 1) allows skipping test runs that are requested by the device.If the switch is set such that a test run can be skipped, then it must be noted that the operator has the possibility of evading the automatic test of the safety systems.The person requesting such a setting is responsible for this procedure.


Function

1ONOFF

Not assigned

2ONOFF

T1 test Serial sequenceParallel sequence

3ONOFF

T1 test SkipMandatory

4ONOFF

Test Service "ON" (single test steps can be selected; dialysis mode not possible)"OFF" (automatic T1 test)

5ONOFF

Cyclic PHTEvery 2 minutes and events display (Service)Every 12.5 minutes, alarm output only with cyclic PHT alarm

6ONOFF

Cyclic PHT"ON""OFF"

7ONOFF

Air detector Not permittedWith P.C.B. LP 450-2

8ONOFF

Not assigned


1 2 3 4 5 6 7 8ON

OFF

SW2SW1LP632Fresenius Medical Care 4008 S SM-EN 1/05.09 3-11



Function

1ONOFF

DIASAFE / DIASAFE plusOnOff

2ONOFF

Not assigned

3ONOFF

Not assigned

4ONOFF

HydraulicsWith HPUNot permitted

5ONOFF

V39 testOffOn

6ONOFF

Fast heater for HDISInactiveActive

7ONOFF

Not assigned

8ONOFF

Not assigned


1 2 3 4 5 6 7 8ON

OFF

SW2SW1LP6323-12 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 3: InstallationRe 2.4 V91, V99, V100 are functional and tight (test not applicable with activated CDS or with activated rinse section test).


Re 2.5 Rinse to remove any preservatives.

Operating condition: Cleaning / rinsing

Turn the hemodialysis device on.Set the Service switch to ON (up) (heater rod inactive).Press the Cleaning key. Rinse and reset the Service switch to OFF (down) after having completed the rinse program.

Re 2.6 Connect the Diasafe filter and run the "filter change" program.

Operating condition: Cleaning / filter change

Use the "filter change" program item in the cleaning menu and start the disinfection program requested by the device.

Re 2.7 Blood pump emergency crank attached to housing rear.


Re 3 Checking the hydraulics

Re 3.1 Water inlet pressure (reduced): 1.2 bar (+0.2 bar / 0.3 bar)

Operating condition: CALIBRATION

Re 3.2 Loading pressure: 1.45 bar (0.05 bar)


Re 3.3 Degassing pump negative pressure: 0.82 bar (0.01 bar)


Re 3.4 Relief pressure of balancing chamber at 800 ml/min:2.2 bar (0.05 bar)


Re 4 Checking the zero point of the pressure display (art./ven.)

Re 4.1 Arterial zero point: 0 mmHg (10 mmHg)


Re 4.2 Venous zero point: 0 mmHg (10 mmHg)


Re 5 Checking the dialysate flow

Collect the fluid at the drain, using an appropriate measuring cylinder.If necessary, make settings according to calibration instructions.

Re 5.1 Dialysate flow 800 ml/min (desired: 765 to 837 ml/min)

Operating condition: CALIBRATIONFresenius Medical Care 4008 S SM-EN 1/05.09 3-13

Chapter 3: InstallationRe 5.2 Dialysate flow 500 ml/min (desired: 471 to 528 ml/min)


Re 5.3 Dialysate flow 300 ml/min (desired: 279 to 321 ml/min)


Re 6 Checking the temperature

Re 6.1 Reference device temperature: desired = 37 C (1 C)


Check the desired temperature of 37 C (1 C) using a reference measuring instrument connected between the dialyzer couplings.

Re 6.2 Hemodialysis device temperature display: desired = 37 C (0.5 C)


Temperature display:The display on the hemodialysis device must display 37 C (0.5 C) (NTC 109 inactive).

Re 7 Checking the conductivity(Connect the bibag)

Re 7.1 Conductivity of reference device


Measure the conductivity using a reference measuring instrument connected between the dialyzer couplings.

Re 7.2 Conductivity of hemodialysis device display:desired = value of reference instrument ( 0.2 ms/cm)


The display of the hemodialysis device may deviate from the value measured by means of the reference instrument by no more than 0.2 ms/cm.

Re 8 Checking the blood leak detector


Ensure that the operating temperature of the device has reached approx. 37 C. Then check the values. The rear of the device must be closed to protect it from any incident ambient light.

Re 8.1 Blood leak: desired = 5 V (0.2 V)


Re 8.2 Dimness: desired = 5 V (0.3 V)

Operating condition: CALIBRATION3-14 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 3: InstallationRe 9 Checking the dialysate pressureCheck the zero point according to Chapter 9: Calibration / Adjustment (see Part 14.1: Dialysate pressure, page 9-33). With the dialysate circuit open, the water level must be approx. 10 cm above the shunt interlock.

Re 9.1 Zero point checked (flow off)


Re 9.2 Slope checked


Re 10 Checking extracorporeal components

Re 10.1 Blood pumps: Check the blood pump rate.

Operating condition: CALIBRATION / BP-Rate CHECK

Re 10.2 Operating condition: CALIBRATION

Check the changeover points according to table (see chapter 11.2.1.25, page 11-25).

Re 10.3 Blood pump stop alarm checked.


Opening of the blood pump cover initiates a BP stop alarm after 30 sec (factory setting).

Re 10.4 Venous line clamp closes after blood alarm.


The venous tube clamp must close in the event of blood alarm.

Re 10.5 Pressure of approx. 2 bar in the venous bubble catcher.


The pressure may not drop by more than 0.1 bar within 3 minutes.

Generate a pressure of approx. 2 bar in the venous bubble catcher.The pressure may not drop by more than 0.1 bar within 3 minutes (see chapter 9.3.1.3, page 9-51).

Re 11 Setup settings (PC Service program)

Re 11.1 Make Setup settings in the Service program and transfer data to the 4008S dialysis device. The dialysis device is in calibration mode / CALIBRATION.


Re 11.2 Erase the error memory.


Re 11.3 Download setup and calibration data.

Operating condition: CALIBRATIONFresenius Medical Care 4008 S SM-EN 1/05.09 3-15

Chapter 3: InstallationRe 11.4 Print setup data.


Re 12 Checking the electrical safety

Electrical safetyAccording to (DIN) EN 62353: 2008, IEC 62353: 2007

Re 12.1 Visual inspection performed according to item 1 (Preparation).


Fuses accessible from the outside comply with the indicated values. Labels and identifications are present and legible. The mechanical condition permits further safe use. No damage or contaminations detectable. Power cable not damaged.

Re 12.2 Measure protective earth resistance.Max. 0.3 (with power cable)Operating condition: Off

The protective earth resistance must be checked on the following measurement points.

Measurement point: power supply unit (power supply unit housing)

Re 12.3 Measure leakage current (device leakage current).

Operating condition: Dialysis mode

Differential current measurement according to figure 5

or 3-16 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 3: InstallationDirect measurement according to fig. 4

Basic conditions: Measurement of the protective earth resistance performed. Perform the measurement with the hemodialysis device being at

operating temperature. Dialysate:

Dialysis temperature: 37 CDialysate flow: 300 ml/minConductivity: 13 mS/cm

When performing a direct measurement, the following precautions also must be observed:The device must be insulated when installed.All external connections must have been removed from the device.

The line voltage during the measurement will be recorded, as well as the maximum device leakage current, scaled to the nominal voltage of the power supply. Maximum device leakage current: 500 A

Example:Line voltage during measurement: 225 VDevice leakage current:mains polarity 1: 180 Amains polarity 2: 120 AMaximum value of both mains polarities: 180 ANominal voltage of power supply: 230 VScaled to nominal voltage 184 A(180 A: 225 V x 230 V = 184 ADevice leakage current < 500 A: OK

Additional requirements:If the value scaled to the nominal voltage is higher than 90 % of the admissible alarm limit (= 450 A), the last measured value or the first measured value must additionally be considered for the rating.If the device leakage current has considerably increased since the last measurement or has continuously increased since the first measurement (slow deterioration of the insulation), or if the sum composed of the current value plus the difference since the last measurement is > 500 A, the measurement has not been passed.

Example 1:Device leakage current: 470 ALast measured value: 450 A470 + (470 450) = 470 + 20 = 490 = OKFresenius Medical Care 4008 S SM-EN 1/05.09 3-17

Chapter 3: InstallationExample 2:Device leakage current: 470 ALast measured value: 390 A470 + (470 390) = 470 + 80 = 550; not passed

Re 13 Functional test

Re 13.1 T1 test performed

Operating condition: dialysis mode

Perform additional checks only after completion of the T1 test. T1 test passed without errors.

Re 14 Final check

Re 14.1 Power failure alarm continuous sound text displayed: Emergency operation


Re 14.2 Activation of air separation of degassing pump


Text display with further air separation and OD senses opaque:

Fill program

Re 14.3 Set temperature at a desired value of 37 C (36.8 to 37.2 C)


Re 14.4 Expected conductivity value


Compare the conductivity displayed on the monitor with the specifications on the acid / concentrate container.

Re 14.5 Run the disinfection program.

Operating condition: cleaning / disinfection

Re 14.6 Make entries in the medical device register.


Re 14.7 Operating Instructions and accessories package complete and match the device.


Re 14.8 Attach TSC inspection label.


Confirming the test Test equipment used:Type and serial number of the test equipment used.3-18 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 3: InstallationComments:Use this section to note down any irregularities which occurred during the check.

Date, signature, stampPerformance of the check must be confirmed with the date, the signature of the person performing the check and a stamp.

Assessing the test The device has been released for further use.Attach inspection label.

It must be ensured that the intended use of the device will not present a hazard to patients, operators and other third parties.

Within the scope of the overall assessment, the tester must make a definite decision whether the device may be used or not. The responsible organization must immediately be informed of any defects detected.

Date of next inspection:The next inspection date has to be entered in the report.The intervals specified by the manufacturer have to be observed.

Comments:Use this section to note down any irregularities which occurred during the assessment.

Date, signature, stamp:Assessment of the initial start-up has to be confirmed with date, tester's signature and stamp.Fresenius Medical Care 4008 S SM-EN 1/05.09 3-19

Chapter 3: Installation3.4 Decommissioning / removal from service / recommissioning

3.4.1 Decommissioning

3.4.2 Removal from service

3.4.3 Recommissioning3-20 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 4: Specifications4 Specifications

4.1 Dimensions and weight

Dimensions Height: approx. 137 cm (without IV pole)Width: approx. 48 cmDepth: approx. 48 cm (without housing footing)Base: approx. 48 x 63 cm2

Weight Approx. 86 kg (without options)

4.2 Type label (identification of the device)

The type label shown is only an example. The decisive criterion is the data specified on the type label of the device .

1 Identification of electric and electronic devices

2 Connection values

3 Protection against ingress of liquids: drip-proof

4 Caution: consult accompanying documents

5 EC: Equipment Code

6 Degree of protection against electrical shock: type B

7 CE mark

8 Type identification, serial number Fresenius Medical Care 4008 S SM-EN 1/05.09 4-1

Chapter 4: Specifications4.3 Electrical safety

Electrical safety (classification according to EN 60601-1, IEC 601-1)

Type of protection against electrical shock

Safety class I

Degree of protection against electric shock

type B

Degree of protection against ingress of liquids

drip-proof

Leakage currents According to EN 60601-1

4.4 Electrical supply

Line voltage 100 V AC, 10 %, 47 to 63 Hz, 16 A110 V AC, 10 %, 47 to 63 Hz, 15 A120 V AC, 10 %, 47 to 63 Hz, 14 A127 V AC, 10 %, 47 to 63 Hz, 14 A220 V AC, 10 %, 47 to 63 Hz, 9 A230 V AC, 10 %, 47 to 63 Hz, 9 A240 V AC, 10 %, 47 to 63 Hz, 9 A

The decisive criterion is the line voltage and the operating current specified on the type label of the device.

Power supply(internal)

+5 V, +0.3 V short-circuit-proof

+12 V, +0.4 V, short-circuit-proof

+24 V, 0.7 V, short-circuit-proof

Battery Lead-acid battery (maintenance-free)

18 V (= 3 x 6 V) / 3 Ah

4.5 Fuses

Battery 1 x T 3.15 A; Power supply unit, Fuse in housing foot (rear)/SI54-2 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 4: Specifications4.6 Guidance and manufacturers declaration for EMC (IEC 60601-1-2:2001)

Guidance and manufacturers declaration - Electromagnetic emissions The 4008 S hemodialysis system is ready for use in an environment as described below. The customer or the user of the 4008 S hemodialysis system should assure that it is used in such an environment.Emissions test Compliance Electromagnetic environment guideline RF emissions CISPR 11 Group 1 The 4008 S hemodialysis system uses RF energy only for its

internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 Class B The 4008 S hemodialysis system is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Class B

Voltage fluctuations / flicker emissions IEC 61000-3-3

Complies

Guidelines and manufacturer's declaration Electromagnetic immunity The 4008 S hemodialysis system is intended for use in the electromagnetic environment specified below. The customer or the user of the 4008 S hemodialysis system should assure that it is used in such an environment.Immunity test IEC 60601 test level Compliance level Electromagnetic environment

guideline Discharge of staticelectricity (DSE)IEC 61000-4-2

6 kV contact8 kV air

6 kV contact8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst IEC 61000-4-4

2 kV for power supply lines1 kV for input/output lines

2 kV for power supply linesNot applicable

Mains power quality should be that of a typical commercial and/or hospital environment.

Surge IEC 61000-4-5 1 kV differential mode2 kV common mode

1 kV differential mode2 kV common mode

Mains power quality should be that of a typical commercial and/or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

95 % dip in UT) for 0.5 cycle

95 % dip in UT) for 0.5 cycle

After power supply interruptions, the battery of the 4008 S hemodialysis system takes over the supply without delay.40 % UT (60 % dip in

UT) for 5 cycles40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

70 % UT (30 % dip in UT) for 25 cycles

95 % dip in UT) for 5 sec

95 % dip in UT) for 5 sec

Power frequency (50 / 60 Hz) magnetic field IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level.Fresenius Medical Care 4008 S SM-EN 1/05.09 4-3

Chapter 4: SpecificationsPortable and mobile RF communications equipment should be used no closer to any part of the 4008 S hemodialysis device , including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance: Conducted RF IEC 61000-4-6

3 Vrms150 kHz to 80 MHz

3 V d = 1.2 P for 150 kHz to

Chapter 4: SpecificationsRecommended separation distances between portable and mobile RF telecommunication devices and the hemodialysis system 4008 S The 4008 S hemodialysis system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the hemodialysis system can 4008 S contribute to avoiding electromagnetic errors, by adhering to the minimum distance between portable and mobile HF telecommunications devices (transmitters) and the hemodialysis system 4008 S dependent on the exit performance of the communication device, as indicated below.Rated maximum output power of transmitter

W

Separation distance according to frequency of transmitter m 150 kHz to < 80 MHz

d = 1.2 P 80 MHz to

Chapter 4: Specifications4.7 Operating conditions

Water inflow pressure 1.5 up to 6.0 bar

Water inflow temperature 5 C to 30 C for integrated hot rinse: 85 C to 95 C

Water inflow rate 1.3 L/min; at an inlet pressure of 1.5 bar

Water drain 0 to 100 cm above the ground; each dialysis device must have its own free fall air gap of at least min. 2 cm. The water drain must be positioned lower than the dialyzer.

Concentrate supply 0 to 100 mbar; max. suction height 1 m, max. height of fall m (for central concentrate supply 0 to 500 mbar)

Heat dissipation Dialysis: approx. 400 watts (at an ambient temperature of 20 C)Hot rinsing: approx. 520 watts (at an ambient temperature of 20 C)

Operating temperature range

15 C to 35 C

Atmospheric pressure 700 hPa up to 1060 hPa

Relative humidity 30 % to 75 %, temporarily 95 %

Stability 5

IV pole pressure Maximum 5 kg

Temporary downtime Prior to the downtime, it is recommended to carry out a hot rinse program without a cooling rinse (PGM 2) and a disinfection prior to commencing operations.

4.8 Storage conditions

Transportation and storage

In both cases, the device must be filled with antifreeze containing disinfectant. Composition:48.75 % water, 48.75 % glycerin, 2.5 % Teta-Plusor49.875 % water, 49.875 % glycerin, 0.25 % ClearSurf

Frost resistance Down to approx. 20 C

Storage temperature 20 C to +60 C (with antifreeze) +5 C to +60 C (without antifreeze)

Charging the integrated batteries

Upon receipt of the hemodialysis device, the integrated batteries must be charged as follows: Connect the device to the external power supply by means of the

power cable. Then turn the device on for approx. 10 hours.4-6 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 4: SpecificationsIf the device is not used, this procedure should be repeated every six months.

4.9 External connection options

RS232 Interface for data transfer to FINESSE (accessory part).

Input/output For connection of external auxiliary equipment. (maximum 24 V/24 W)

Alarm in (alarm input)

Can be used for the connection of an external pushbutton switch. This button can be used to release an alarm.

Alarm out (alarm output)

Potential-free alarm output. Alternating contact (maximum 24 V/24 W).

For connection of an external alarm indicator (lamp). (Nurse call) Connection by means of a 5-pin diode plug (stereo 180) via a shielded line. Shield grounded on either side.

Diagnosis For inhouse computer diagnosis.

4.10 Override conditions

Audible alarm suppression Mute alarm time: adjustable in the SETUP MENU from 1 to 2 minutes(factory setting: 1 minute).

Any new alarm reactivates the silenced audible alarm.

Blood leak suppression Override time: 2 minutes.

Alarm override The key Start/Reset overrides: an arterial and venous pressure alarm for approx. 8 seconds a blood leak alarm for approx. 8 seconds a TMP alarm for approx. 2 minutes (time determined by the UF

coefficient)

Caution

Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all configurations must comply with the requirements for medical electrical equipment (see IEC 60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the device complies with the requirements for medical electrical equipment. Attention is drawn to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative or the technical service department.Fresenius Medical Care 4008 S SM-EN 1/05.09 4-7

Chapter 4: SpecificationsWhen overriding a safety system, the responsibility for the patients safety rests with the operator of the device.

4.11 Materials used

Screwlock Loctite 2434-8 Fresenius Medical Care 4008 S SM-EN 1/05.09

Chapter 5: Setu

Documents

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