Fresenius Medical
Hemodialysis Machine
5008 Service Manual Part no M54 223 1 Sw Ver 4.50 Edition 15A-2014
Service Manual
380 Pages
Preview
Page 1
5008S Service Manual Software version: 4.50 Edition: 15A-2014 Part no.: M54 223 1 0123
Table of contents 1
Index
2
Important information
3
2.1
How to use the Service Manual... 2-1
2.2
Significance of warnings ... 2-2
2.3
Significance of notes ... 2-2
2.4
Significance of tips... 2-2
2.5
Precautions for working on the hemodialysis system ... 2-3
2.6 2.6.1
Warnings ... 2-4 Warnings relating to electricity... 2-4
2.7
Addresses ... 2-4
Installation 3.1 3.1.1 3.1.2 3.1.3 3.1.4
Initial start-up... 3-1 Important information on initial start-up ... 3-1 Important information for operation in the home healthcare environment ... 3-2 Initial start-up report... 3-2 Explanatory notes for completing the initial start-up report ... 3-6
3.2
Transporting the hemodialysis system... 3-30
3.3 3.3.1 3.3.2 3.3.3 3.3.4
Decommissioning... 3-33 Important information on decommissioning... 3-33 Accessories required for decommissioning ... 3-33 Decommissioning report and identification sheet ... 3-33 Explanatory notes for completing the decommissioning report and identification sheet ... 3-36
3.4 3.4.1 3.4.2 3.4.3 3.4.4
Decommissioning extension... 3-41 Important information on decommissioning extension ... 3-41 Accessories required for decommissioning extension... 3-41 Decommissioning extension report ... 3-41 Explanatory notes for completing the decommissioning extension report... 3-43
3.5 3.5.1 3.5.2 3.5.3
Recommissioning after decommissioning ... 3-45 Important information on recommissioning after decommissioning... 3-45 Recommissioning report after decommissioning... 3-45 Explanatory notes for completing the recommissioning report after decommissioning ... 3-47
3.6 3.6.1
Removal from service ... 3-51 Important information on removal from service ... 3-51
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4
5
Specifications 4.1
Dimensions and weight... 4-1
4.2
Identification label (device marking)... 4-2
4.3
Environment... 4-3
4.4
Electrical safety ... 4-3
4.5
Electrical power supply... 4-4
4.6
Fuses ... 4-4
4.7
Power supply network... 4-5
4.8 4.8.1 4.8.2 4.8.3
Guidance and manufacturer's declaration on EMC... 4-7 Electromagnetic emissions ... 4-7 Electromagnetic immunity... 4-7 Recommended separation distances between portable and mobile RF telecommunications equipment and the hemodialysis system ... 4-9
4.9
Operating conditions... 4-11
4.10
Consumption and energy data ... 4-12
4.11
Storage conditions ... 4-14
4.12
External connection options ... 4-15
4.13
Override conditions... 4-16
4.14
Operating programs ... 4-16
4.15
Dialysate circuit and safety systems ... 4-18
4.16
Extracorporeal blood circuit and safety systems... 4-21
4.17
Materials used... 4-24
4.18
DIASAFE®plus ... 4-27
4.19
OCM ... 4-27
4.20
ONLINEplus™ ... 4-27
4.21
Network... 4-28
4.22
Wireless (option) - in monitor... 4-29
4.23
Single-Needle (option)... 4-29
4.24
VenAcc (option) monitoring unit... 4-30
4.25
BPM (option) ... 4-30
4.26
BTM (option)... 4-31
4.27
HOME-HD (option) – remote control ... 4-31
Setup / service program 5.1 5.1.1 5.1.2
iv
SYSTEM ... 5-1 SYSTEM – selecting / setting ... 5-1 SYSTEM – overview... 5-2 5.1.2.1 Settings ... 5-2 5.1.2.2 SERVICE menu (Service setup) ... 5-3
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5.1.2.3 5.1.2.4
6
USER SETUP menu ... 5-3 APPLICATIONS menu ... 5-3
5.2 5.2.1 5.2.2
SETUP (Service setup)... 5-3 SETUP (Service setup) – selecting / setting... 5-3 SETUP (Service setup) – overview ... 5-4 5.2.2.1 Settings Hydraulics... 5-4 5.2.2.2 Settings EBM ... 5-5 5.2.2.3 Settings Air bubble detector ... 5-7 5.2.2.4 Define cleaning parameters ... 5-8 5.2.2.5 Miscellaneous ... 5-10 5.2.2.6 Network ... 5-11 5.2.2.7 BTM (can only be selected if the system option is available)... 5-12 5.2.2.8 Radio (can only be selected if the system option is available) ... 5-12 5.2.2.9 Software options ... 5-13
5.3 5.3.1 5.3.2
USER SETUP... 5-14 USER SETUP – selecting / setting... 5-14 USER SETUP – overview ... 5-15 5.3.2.1 Blood line ... 5-15 5.3.2.2 Blood pump ... 5-15 5.3.2.3 Rinse / reinfusion volume (only when prepared with NaCl solution) ... 5-15 5.3.2.4 Anticoagulation... 5-16 5.3.2.5 Dialysate ... 5-18 5.3.2.6 Ultrafiltration ... 5-26 5.3.2.7 Alarm processing... 5-27 5.3.2.8 User interface ... 5-29 5.3.2.9 Cleaning ... 5-31 5.3.2.10 Auto On ... 5-32 5.3.2.11 Emergency (reaction after pressing the Emergency button) ... 5-35 5.3.2.12 Extended safety ... 5-35 5.3.2.13 ONLINE ... 5-36 5.3.2.14 OCM ... 5-37 5.3.2.15 Single-Needle (can only be selected if the system option is available)... 5-38 5.3.2.16 Miscellaneous ... 5-38 5.3.2.17 BPM (can only be selected if the system option is available)... 5-39 5.3.2.18 BTM (can only be selected if the system option is available)... 5-39 5.3.2.19 Home-HD (can only be selected if the system option is available) ... 5-40 5.3.2.20 VenAcc (can only be selected if the system option is available) ... 5-40
5.4 5.4.1 5.4.2
APPLICATIONS... 5-41 APPLICATIONS – selecting / setting... 5-41 APPLICATIONS – overview ... 5-41 5.4.2.1 PatientCard ... 5-41 5.4.2.2 Training ... 5-42 5.4.2.3 Fluid sampling with sampling set... 5-42
5.5
Service Software (Quick Guide) ... 5-44
Technical safety checks / maintenance procedures 6.1
Important information on TSC / MA ... 6-1
6.2
Accessories required for the TSC / MA ... 6-2
6.3
TSC / MA report ... 6-2
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6.4
Explanatory notes for completing the TSC / MA report ... 6-7
6.5
TSC report ... 6-43
7
Error messages
8
Test equipment and accessories
9
Calibration / adjustment
vi
9.1 9.1.1 9.1.2
SERVICE ... 9-1 SERVICE – selecting... 9-1 SERVICE – overview... 9-1 9.1.2.1 Flow diagram ... 9-1 9.1.2.2 CALIBRATE ... 9-1 9.1.2.3 DIAGNOSTICS... 9-1 9.1.2.4 SETUP ... 9-1 9.1.2.5 MODULE ... 9-1 9.1.2.6 VARIOUS ... 9-1 9.1.2.7 UPDATE ... 9-2
9.2 9.2.1
Flow diagram... 9-2 Setting the max. water inflow... 9-2
9.3 9.3.1
CALIBRATE ... 9-3 CALIBRATE – overview... 9-3 9.3.1.1 Calibrate touch screen ... 9-3 9.3.1.2 Pressure transducer (S03/S07/S15/S16) ... 9-4 9.3.1.3 Degassing (A02/P01) ... 9-4 9.3.1.4 Flow pump (A03) ... 9-6 9.3.1.5 Temperature (PT7/PT8/PT9)... 9-7 9.3.1.6 Conductivity (CD7/CD9) ... 9-7 9.3.1.7 Volumes ... 9-8 9.3.1.8 Blood leak... 9-9 9.3.1.9 OCM ... 9-9 9.3.1.10 ECMP configuration (eccentric membrane pumps)... 9-10
9.4 9.4.1
DIAGNOSTICS... 9-11 DIAGNOSTICS – overview... 9-11 9.4.1.1 Monitor ... 9-11 9.4.1.2 EBM... 9-12 9.4.1.3 Hydraulics... 9-13 9.4.1.4 Power supply unit ... 9-15 9.4.1.5 Radio (option) ... 9-16 9.4.1.6 BPM (option) ... 9-17 9.4.1.7 BTM (option)... 9-17
9.5
SETUP... 9-17
9.6 9.6.1
MODULE ... 9-17 MODULE – overview ... 9-17 9.6.1.1 Novram ... 9-17
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VARIOUS ... 9-18
9.8 9.8.1 9.8.2 9.8.3
UPDATE... 9-18 Updating the software version in a replaced module... 9-19 Updating the software version of the hemodialysis system with a new CF card ... 9-20 Updating the software version of the hemodialysis system with the 5008 PC Service Software ... 9-21
9.9
Remote maintenance ... 9-22
10 Servicing / repair 10.1
Important information on servicing / repair ... 10-1
10.2 10.2.1 10.2.2 10.2.3
Component overview ... 10-1 Monitor... 10-2 Extracorporeal Blood Circuit Module (EBM)... 10-3 Hydraulics... 10-4 10.2.3.1 Front view... 10-4 10.2.3.2 Left side view ... 10-5 10.2.3.3 Right side view ... 10-6 10.2.3.4 Rear view ... 10-7 10.2.3.5 Rear view with connectors ... 10-8
10.3 10.3.1 10.3.2 10.3.3 10.3.4 10.3.5
Basic procedures ... 10-9 Tilting the hemodialysis system back ... 10-9 Installing components with SNAPLOC attachments... 10-9 Fitting components with self-cutting screws ... 10-10 Closing and opening the tube clamp ... 10-11 Connecting the tubing to the adapter ... 10-12
10.4
Wrench torques ... 10-13
10.5 10.5.1 10.5.2 10.5.3 10.5.4 10.5.5 10.5.6 10.5.7 10.5.8 10.5.9
Housing ... 10-14 Removing and installing the IV pole ... 10-14 Removing and installing the shunt interlock ... 10-14 Removing and installing the microswitch in the installed shunt interlock ... 10-15 Removing and installing the shunt interlock mark ... 10-16 Removing and installing the dialyzer coupling... 10-17 Removing and installing the dialyzer holder ... 10-17 Removing and installing the blood pressure monitor (BPM) (option) ... 10-18 Opening and closing the media supply rail... 10-19 Opening and closing the side panel ... 10-20
10.6 10.6.1 10.6.2
Cart ... 10-21 Removing and installing the concentrate container holder... 10-21 Removing and installing the braking mechanism ... 10-22
10.7 10.7.1 10.7.2
Rechargeable batteries ... 10-23 Removing and installing the powerpack ... 10-23 Removing and installing the rechargeable battery remote control (option) ... 10-23
10.8 10.8.1 10.8.2 10.8.3 10.8.4
Monitor ... 10-24 Removing and installing the monitor and the monitor support arm ... 10-24 Adjusting monitor movements ... 10-28 Monitor transport protection... 10-31 Updating the monitor operating system M1... 10-31
10.9
Power supply unit and power cable ... 10-32
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10.9.1 10.9.2 10.9.3
Removing and installing the power cable ... 10-32 Removing and installing the power supply unit... 10-33 Removing and installing the power plug fuse (UK version only)... 10-34
10.10 Extracorporeal Blood Circuit Module (EBM)... 10-35 10.10.1 Removing and installing the EBM doors... 10-35 10.10.2 Opening and closing the EBM ... 10-36 10.10.3 Removing and installing the EBM... 10-36 10.10.4 Replacing the pneumatic tubings in the EBM ... 10-40 10.10.5 Removing and installing the arterial pressure measurement unit... 10-41 10.10.6 Removing and installing the venous and arterial occlusion clamp ... 10-42 10.10.7 Resetting the zero point of the pressure transducers (EBM)... 10-43 10.10.8 Verification / repair procedure in case of ingress of blood or fluid via the pressure line... 10-44 10.10.9 Checking the pneumatics of the arterial pressure measurement unit... 10-46 10.10.10 Checking the venous pressure transducer for leakage ... 10-47 10.10.11 Checking the Single-Needle pressure transducer with compliance chamber for leakage... 10-48 10.10.12 Removing and installing the grip handle of the occlusion clamps ... 10-49 10.10.13 Removing and installing the air bubble detector ABD ... 10-50 10.10.14 Removing and installing the heparin pump grip handle... 10-50 10.10.15 Removing and installing the heparin pump length sensor ... 10-51 10.10.16 Removing and installing the heparin pump... 10-53 10.10.17 Removing and installing the level detector ... 10-57 10.10.18 Removing and installing the online module (option) ... 10-58 10.10.19 Removing and installing the blood temperature monitor (BTM) (option) ... 10-59 10.11 Hydraulics ... 10-60 10.11.1 Removing and installing the pressure reducing valve A04, water inlet... 10-60 10.11.2 Removing and installing the heat exchanger... 10-60 10.11.3 Removing and installing the float switch S01 of the water inlet chamber ... 10-62 10.11.4 Removing and installing the degassing orifice... 10-64 10.11.5 Removing and installing the heater rod ... 10-65 10.11.6 Removing and installing the concentrate pump... 10-66 10.11.7 Removing and installing the bicarbonate pump... 10-67 10.11.8 Removing and installing the UF pump... 10-68 10.11.9 Removing and installing the gear pump drive... 10-69 10.11.10 Removing and installing the balancing chamber ... 10-70 10.11.11 Removing and installing the blood leak detector ... 10-71 10.11.12 Removing and installing the flap lid ... 10-73 10.11.13 Removing and installing the bibag® connector... 10-74 10.11.14 Removing and installing the concentrate rinse chamber ... 10-75 10.11.15 Removing and installing the bicarbonate rinse chamber ... 10-78 10.11.16 Removing and installing the CDS block... 10-79 10.11.16.1 Vent valve of CDS block ... 10-80 10.11.17 Temperature and conductivity sensors, calibration after replacement ... 10-82 10.11.18 Disinfectant valves (yellow labels) V20 and V34 ... 10-83 10.11.19 Deactivating the Flush function... 10-85
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10.12
Checking the network interface ... 10-87
10.13 10.13.1 10.13.2 10.13.3 10.13.4 10.13.5 10.13.6 10.13.7 10.13.8
Printed circuit boards... 10-89 PCB LP 1102 Controller board (C167) ... 10-89 PCB LP 1104 Monitor power supply board... 10-92 PCB LP 1105 Power supply CPU... 10-95 PCB LP 1106 Power supply distribution board... 10-97 PCB LP 1107-4 EBM I/O board ... 10-99 PCB LP 1126 Heparin pump control board ... 10-104 PCB LP 1131 Monitor operating mode indicator ... 10-105 PCB LP 1131-2 Monitor operating mode indicator with wireless module ... 10-106
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10.13.9 PCB LP 1134 Monitor card reader ... 10-107 10.13.10 PCB LP 1140 Hydraulic sensors ... 10-108 10.13.11 PCB LP 1141-3 Hydraulics actuators ... 10-110 10.13.12 PCB LP 1142 External I/O board... 10-112 10.13.13 PCB LP 1145-1 Monitor distribution board ... 10-115 10.13.14 PCB LP 1150 Display failure sensor ... 10-118 10.13.15 PCB LP 1169 Remote control ... 10-119 10.13.16 PCB LP 1170 Charging cradle ... 10-120 10.13.17 PCB LP 1202 Controller board (C167) ... 10-121 10.13.17.1 Combination of PCB LP 1202 with PCB LP 1107 / PCB LP 1141... 10-123 10.13.18 PC board ... 10-124 10.13.19 Connector pin assignment on electronics chassis... 10-126 10.14 Troubleshooting ... 10-127 10.14.1 Troubleshooting with dark display ... 10-127 10.14.2 Troubleshooting in case of unclear crashes and suspected CAN bus problems ... 10-130
11 Functional description 11.1
Complete system... 11-1
11.2
Overview of PCBs... 11-2
11.3
Monitor ... 11-3
11.4
Power supply unit... 11-5
11.5
Extracorporeal Blood Circuit Module (EBM)... 11-7
11.6
Pneumatics ... 11-8
11.7
Hydraulics (block diagram / description) ... 11-11
11.8
Hydraulics (flow diagram, legend, description)... 11-13
12 Appendix
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Chapter 1: Index
1
Index
A Accessories and test equipment 8-1 Accessories required – Decommissioning 3-33 – Decommissioning extension 3-41 – TSC / MA 6-2 Addresses 2-4 Adjusting monitor movements 10-28 Adjustment 9-1 Air bubble detector 4-22 Air bubble detector ABD, removing and installing 10-50 Air bubble detector settings 5-7 Alarm output 4-16 Alarm override 4-16 Alarm processing 5-27 Anticoagulation 5-16 Antifreeze 4-14 APPLICATIONS – PatientCard 5-41 – Sampling 5-42 – selecting / setting 5-41 – Training 5-42 AquaUNO / AquaC UNO H 4-15 Arterial occlusion clamp, removing and installing 10-42 Arterial pressure measurement 4-21 Arterial pressure measurement unit, removing and installing 10-41 Atmospheric pressure 4-12 Audible alarm 4-23 Audio paused 4-16 Authorized persons 2-3 Auto On 5-32 AutoFlow 4-20
B Balancing chamber, removing and installing 10-70
Batteries – PC board 4-4, 10-125 – PCB LP1105 4-4, 10-96 – TSC / MA 6-25 – VenAcc (option) 4-4, 4-30 Battery pack, removing and installing 10-23 bibag® connector – switch position 10-109 bibag® connector, removing and installing 10-74 Bicarbonate pump, removing and installing 10-67 Bicarbonate rinse chamber, removing and installing 10-78
– Temperature (PT7/PT8/PT9) 9-7 – Volumes 9-8 Cart 10-21 CDS block, removing and installing 10-79 Central delivery system (option) 4-12 Checking the pneumatics of the arterial pressure measurement unit 10-46 Checking the Single-Needle pressure transducer with compliance chamber for leakage (option) 10-48
Block diagrams – EBM 11-7 – Hydraulics 11-11 – Monitor 11-3 – Pneumatics 11-8 – Power supply unit 11-5
Circulation 4-17
Blood leak detector 4-18
Closing plugs 8-4
Blood leak detector, removing and installing 10-71
Color code of the heater rod connector 10-66
Blood lines 5-15
Component overview – EBM 10-3 – Hydraulics 10-4 – Monitor 10-2
Blood pressure monitor (BPM) (option), removing and installing 10-18 Blood pump 4-21, 5-15 Blood temperature monitor (BTM) (option), removing and installing 10-59 BPM (option) 4-30, 5-39 BTM (option) 4-31, 5-12, 5-39
C CALIBRATION – Blood leak 9-9 – Calibrate touch screen 9-3 – Conductivity (CD7/CD9) 9-7 – Degassing (A02/P01) 9-4 – ECMP configuration 9-10 – Flow pump (A03) 9-6 – OCM 9-9 – Pressure transducer (S03/S07/S15/S16) 9-4
Checking the venous pressure transducer for leakage 10-47 Cleaning 5-31 Cleaning programs 4-17
Concentrate pump, removing and installing 10-66 Concentrate rinse chamber, removing and installing 10-75 Concentrate supply 4-11 Concentration of disinfectant 4-21 Conductivity sensors – Calibration after replacement 10-82 Connecting the tubing to the adapter 10-12 Connector pin assignment on electronics chassis 10-126 Considerations for working on the hemodialysis system 2-3 Consumption data 4-12
Basic procedures 10-9
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D Deactivating Flush (option) 10-85 Decommissioning 9-18 – Accessories required 3-33 – Explanatory notes for completing the report 3-36 – Identification sheet 3-35 – Important information 3-33 – Report 3-34 Decommissioning extension – Accessories required 3-41 – Explanatory notes for completing the report 3-43 – Important information 3-41 – Report 3-42 Define cleaning parameters 5-8 Degassing orifice, removing and installing 10-64 Descriptions – EBM 11-8 – Hydraulics 11-12, 11-16 – Monitor 11-4 – Pneumatics 11-9 – Power supply unit 11-6 DIAGNOSTICS 9-11 – BPM (option) 9-17 – BTM (option) 9-17 – EBM 9-12 – Hydraulics 9-13 – Monitor 9-11 – Power supply unit 9-15 – Wireless (option) 9-16 Dialysate 5-18 Dialysis water inlet pressure 4-11 Dialysis water inlet rate 4-11 Dialysis water inlet temperature 4-11 Dialysis water quality 4-11 Dialysis water supply line 4-11 DIASAFE®plus 4-27 Dimensions of the hemodialysis system 4-1 Disinfectant valves V20 and V34 (yellow labels) 10-83
E EBM – Block diagram 11-7 – Description 11-8 – Doors, removing and installing 10-35
1-2
– Opening and closing 10-36 – Removing and installing 10-36 – Zero point of the pressure transducers, resetting 10-43 EBM settings 5-5 EcoFlow 4-20 Electrical power supply 4-4 Electrical safety 4-3, 6-37 Electrical safety check 6-37 EMC – Electromagnetic compatibility 4-7 – Electromagnetic emissions 4-7 – Electromagnetic immunity 4-7 – Guidance and manufacturer's declaration 4-7 – Recommended separation distances 4-9 Emergency 5-35 Energy data 4-12 Error messages 7-1 ESD precautions 2-3 Explanatory notes – Decommissioning extension report 3-43 – Decommissioning report 3-36 – Identification sheet 3-36 – Initial start-up report 3-6 – Recommissioning report after decommissioning 3-47 – TSC / MA report 6-7 – TSC report 6-7 Extended safety 5-35 External connection options 4-15 Extracorporeal Blood Circuit Module EBM 10-35
F
– – – – – – – –
PCB LP1106 10-98 PCB LP1107-4 10-102 PCB LP1141-3 10-111 PCB LP1142 10-112 Power plug, UK version 10-34 Power switch 4-4 Rechargeable battery 4-4, 10-7 TSC / MA 6-7, 6-38
G Gear pump drive, removing and installing 10-69 Grip handle of the occlusion clamps, removing and installing 10-49
H Heat exchanger, removing and installing 10-60 Heater rod, removing and installing 10-65 Heparin pump 4-22 Heparin pump grip handle, removing and installing 10-50 Heparin pump length sensor, removing and installing 10-51 Heparin pump, removing and installing 10-53 Home dialysis 3-2 Home healthcare environment 3-2 Home-HD (option) 5-40 Housing 10-14 How to use the Service Manual 2-1 Hydraulics 10-4, 10-60 – Block diagram 11-11 – Description 11-12, 11-16 – Flow diagram 11-13
Flap lid, removing and installing 10-73
Hydraulics settings 5-4
Float switch S01 of the water inlet chamber, removing and installing 10-62
I
Flow diagram 9-2, 11-13 – Description 11-16 – Legend 11-14 Flush (option) 4-18, 10-85 Functional description 11-1 Fuses – PCB LP1104 10-93, 10-129
Identification label 4-2 Illustrations 2-2 Important information 2-1 – Decommissioning 3-33 – Decommissioning extension 3-41 – Initial start-up 3-1 – Operation in a domestic environment 3-2
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Chapter 1: Index
– Recommissioning after decommissioning 3-45 – Removal from service 3-51 – Repair 10-1 – Servicing 10-1 – TSC 6-1 – TSC / MA 6-1 Inclination during operation 4-12 Ingress of blood or fluid via the pressure line 10-44 Initial start-up – Explanatory notes 3-6 – Important information 3-1 – Operation in a domestic environment 3-2 – Report 3-3
– Block diagram 11-3 – Description 11-4 Monitor compatibility matrix 10-116 Monitor operating system, updating 10-31 Monitor transport protection 10-31 Monitor with support arm, removing and installing 10-24
N Network 4-28, 5-11 Network interface, checking 10-87 Note symbol, significance 2-2 Novram 9-17
Installation altitude 4-12 IV pole 4-12
O
J
OCM 4-27, 5-37
Jumpers – PCB LP1102 10-90 – PCB LP1104 10-93 – PCB LP1141-3 10-111 – PCB LP1142 10-113
ONLINEplus™ (option) 4-27, 5-36 Opening and closing the media supply rail 10-19 Opening and closing the side panel 10-20 Operating conditions 4-11
L
Operating programs 4-16
LAN 4-15
Operating temperature range 4-12
LEDs – PCB LP1102 10-90 – PCB LP1104 10-93, 10-129 – PCB LP1105 10-96 – PCB LP1107-4 10-102 – PCB LP1131 10-105 – PCB LP1131-2 (wireless module) 10-106 – PCB LP1141-3 10-111 – PCB LP1202 10-122
Operation in the home healthcare environment - Important information 3-2
Level detector, removing and installing 10-57
M Maintenance procedures (MA) 6-1 Manufacturer 2-4 Materials 4-24, 4-26 Materials used 4-24 Miscellaneous 5-10, 5-38 MODULE 9-17 – Novram 9-17
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PCB LP1105 – Battery 10-96 – Calibration after replacement 10-96 – Installation location 10-96 – LEDs 10-96 – Required tests 10-96 PCB LP1106 – Calibration after replacement 10-98 – Fuses 10-98 – Installation location 10-97 – Required tests 10-98 PCB LP1107-4 – Calibration after replacement 10-102 – Fuses 10-102 – Installation location 10-101 – LEDs 10-102 – Required tests 10-102 PCB LP1126 – Calibration after replacement 10-104 – Installation location 10-104 – Required tests 10-104
P
PCB LP1131 – Calibration after replacement 10-105 – Installation location 10-105 – LEDs 10-105 – Required tests 10-105
PC board – Battery 10-125 – Calibration after replacement 10-125 – Installation location 10-125 – Required tests 10-125
PCB LP1131-2 – Calibration after replacement 10-106 – Installation location 10-106 – LEDs 10-106 – Required tests 10-106
PCB LP1102 – Calibration after replacement 10-91 – Connectors 10-90 – Installation location 10-90 – Jumpers 10-90 – LEDs 10-90 – Required tests 10-91
PCB LP1134 – Calibration after replacement 10-107 – Installation location 10-107 – Required tests 10-107
Optical detector 4-22 Override conditions 4-16
PCB LP1104
Monitor 10-24
– Calibration after replacement 10-93 – Fuses 10-93 – Installation location 10-92 – Jumpers 10-93 – LEDs 10-93 – Required tests 10-94 – Solder bridges 10-93
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PCB LP1140 – Calibration after replacement 10-109
1-3
Kapitel 1: Index
– Connector pin assignment 10-126 – Installation location 10-108 – Required tests 10-109
Pneumatics – Block diagram 11-8 – Control states 11-10 – Description 11-9
PCB LP1141 – Connector pin assignment 10-126
Power cable, removing and installing 10-32
PCB LP1141-3 – Calibration after replacement 10-111 – Fuses 10-111 – Installation location 10-110 – Jumpers 10-111 – LEDs 10-111 – Required tests 10-111 PCB LP1142 – Calibration after replacement 10-114 – Fuses 10-112 – Installation location 10-112 – Jumpers 10-113 – Required tests 10-114 PCB LP1145-1 – Calibration after replacement 10-116 – Installation location 10-116 – Monitor compatibility matrix 10-116 – Required tests 10-117 PCB LP1150 – Calibration after replacement 10-118 – Installation location 10-118 – Required tests 10-118 PCB LP1169 – Calibration after replacement 10-119 – Installation location 10-119 – Required tests 10-119 PCB LP1170 – Calibration after replacement 10-120 – Installation location 10-120 – Required tests 10-120 PCB LP1202 – Calibration after replacement 10-122 – Installation location 10-121 – LEDs 10-122 – Required tests 10-122 PCBs, overview 11-2 Pneumatic tubings in the EBM, replacing 10-40
1-4
Power plug fuse (UK version only), removing and installing 10-34 Power supply unit – Block diagram 11-5 – Description 11-6 Power supply unit, removing and installing 10-33 Precautions 2-3 Preparation 4-16 Pressure holding test 4-18 Pressure reducing valve A04, water inlet, removing and installing 10-60 Priming and rinsing 4-16 Printed circuit boards – Combination, PCB LP 1202 with PCB LP 1107 / PCB LP 1141 10-123 – PC board 10-124 – PCB LP1102 10-89 – PCB LP1104 10-92 – PCB LP1105 10-95 – PCB LP1106 10-97 – PCB LP1107-4 with attached PCB LP1158 10-99 – PCB LP1107-4 with integrated PCB LP1158 10-100 – PCB LP1126 10-104 – PCB LP1131 10-105 – PCB LP1131-2 (wireless module) 10-106 – PCB LP1134 10-107 – PCB LP1140 10-108 – PCB LP1141-3 10-110 – PCB LP1142 10-112 – PCB LP1145-1 10-115 – PCB LP1150 10-118 – PCB LP1169 10-119 – PCB LP1170 10-120 – PCB LP1202 10-121 – PCBs, overview 11-2
Q Quick Guide - Service Software 5-44
R Rechargeable battery – Decommissioning 3-35, 9-18 – Fuse 4-4 – Initial start-up 3-18 – Maintenance 4-14 – Removing and installing 10-23 – Specifications 4-4 – Transporting the hemodialysis system 3-31 – TSC / MA 6-25 – Voltage 4-4, 9-15 Recommissioning after decommissioning – Explanatory notes for completing the report 3-47 – Important information 3-45 – Report 3-46 Reinfusion 4-17 Relative humidity 4-12 Relocating a device used in a home healthcare environment 3-2 Remote control (option) – Decommissioning 9-18 – Initial start-up 3-18 – PCB LP1169 10-119 – Rechargeable battery 4-4 – Removing and installing 10-23 – Transporting the hemodialysis system 3-31 – TSC / MA 6-27 – Voltage 4-4, 9-16 Remote maintenance 9-22 Removal from service – Important information 3-51 Removing and installing – Air bubble detector ABD 10-50 – Arterial occlusion clamp 10-42 – Arterial pressure measurement unit 10-41 – Balancing chamber 10-70 – Battery pack 10-23 – bibag® connector 10-74 – Bicarbonate pump 10-67 – Bicarbonate rinse chamber 10-78 – Blood leak detector 10-71 – Blood pressure monitor (BPM) (option) 10-18 – Blood temperature monitor (BTM) (option) 10-59 – Braking mechanism 10-22 – CDS block 10-79
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Chapter 1: Index
– Concentrate container holder 10-21 – Concentrate pump 10-66 – Concentrate rinse chamber 10-75 – Conductivity sensors 10-82 – Degassing orifice 10-64 – Dialyzer coupling 10-17 – Dialyzer holder 10-17 – Disinfectant valve V20 (yellow label) 10-83 – Disinfectant valve V34 (yellow label) 10-83 – EBM 10-36 – EBM doors 10-35 – Flap lid 10-73 – Float switch S01 10-62 – Gear pump drive 10-69 – Grip handle of the occlusion clamps 10-49 – Heat exchanger 10-60 – Heater rod 10-65 – Heparin pump 10-53 – Heparin pump grip handle 10-50 – Heparin pump length sensor 10-51 – IV pole 10-14 – Level detector 10-57 – Monitor with support arm 10-24 – Online module (option) 10-58 – Pneumatic tubings in the EBM 10-40 – Power cable 10-32 – Power plug fuse (UK version only) 10-34 – Power supply unit 10-33 – Pressure reducing valve A04 10-60 – Rechargeable battery remote control (option) 10-23 – Shunt interlock 10-14 – Shunt interlock mark 10-16 – Shunt interlock microswitch 10-15 – Temperature sensors 10-82 – UF pump 10-68 – Venous occlusion clamp 10-42
Removing and installing the dialyzer holder 10-17 Removing and installing the IV pole 10-14 Removing and installing the microswitch in the installed shunt interlock 10-15 Removing and installing the online module (option) 10-58
Single-Needle (option) 5-38 Single-Needle chamber (option) 4-29
Removing and installing the shunt interlock 10-14
SNAPLOC attachment 10-9
Single-Needle Click-Clack 4-23
Removing and installing the shunt interlock mark 10-16
Software options 5-13
Repair procedure in case of ingress of blood or fluid via the pressure line 10-44
Solder bridges – PCB LP1104 10-93
Reports – Decommissioning 3-34 – Decommissioning extension 3-42 – Identification sheet (decommissioning) 3-35 – Initial start-up 3-3 – Recommissioning after decommissioning 3-46 – TSC 6-44 – TSC / MA 6-3
Specifications 4-1
Rinse / reinfusion volume 5-15 Rinse and disinfection flow 4-21
S Self-cutting screws 10-10 SERVICE – CALIBRATION 9-3 – DIAGNOSTICS 9-11 – Flow diagram 9-2 – MODULE 9-17 – Remote maintenance 9-22 – selecting 9-1 – UPDATE 9-18 – VARIOUS 9-18 Service / diagnostics 4-15
Removing and installing the concentrate container holder 10-21
Service Software (Quick Guide) 5-44
Removing and installing the dialyzer coupling 10-17
SETUP (Service setup) – Air bubble detector settings 5-7
5008S
BTM (option) 5-12 Define cleaning parameters 5-8 EBM settings 5-5 Hydraulics settings 5-4 Miscellaneous 5-10 Network 5-11 selecting / setting 5-3 Software options 5-13 Wireless (option) 5-12
Removing and installing the rechargeable battery remote control (option) 10-23
Removing and installing the braking mechanism 10-22
Fresenius Medical Care
– – – – – – – – –
Service setup 5-3
Setting the max. water inflow 9-2
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15A-2014
Software update 9-18, 10-31
Spare parts 2-3 Stability 4-12 Stationary equipment 3-2 Stopping a disinfection program 2-3 Storage conditions 4-14 Styles used in the document 2-1 SYSTEM – Brightness 5-2 – Date 5-2 – Graphic time scale 5-2 – Loudness (audible alarm) 5-2 – selecting / setting 5-1 – Time 5-2 – Timer 5-2
T T1 test 4-16 Technical safety checks (TSC) 6-1 Temperature at water drain 4-11 Temperature sensors – Calibration after replacement 10-82 Test equipment and accessories 8-1 Tilting the hemodialysis system 10-9 Tilting the hemodialysis system back 10-9 Tilting tool 8-6
1-5
Kapitel 1: Index
Tip symbol, significance 2-2 Transmembrane pressure 4-18 Transporting the system within the home healthcare environment 3-2 Treatment 4-16 Troubleshooting in case of unclear crashes and suspected CAN bus problems 10-130 Troubleshooting with dark display 10-127 TSC – Accessories required 6-2 – Explanatory notes for completing the report 6-7 – Important information 6-1 – Report 6-44 TSC / MA – Accessories required 6-2 – Explanatory notes for completing the report 6-7 – Important information 6-1 – Report 6-3 Closing and opening the tube clamp 10-11
U UF pump, removing and installing 10-68 UFC measurement 4-18 Ultrafiltration 4-18, 5-26 Updating monitor operating system M1 10-31 Updating the software version in a replaced module 9-19 Updating the software version of the hemodialysis system with a new CF card 9-20 Updating the software version of the hemodialysis system with the 5008 PC Service Software 9-21 User interface 5-29
– – – – – – – – – – – –
Emergency 5-35 Extended safety 5-35 Home-HD (option) 5-40 Miscellaneous 5-38 OCM 5-37 ONLINE (option) 5-36 Rinse / reinfusion volume 5-15 selecting / setting 5-14 Single-Needle (option) 5-38 Ultrafiltration 5-26 User interface 5-29 VenAcc (option) 5-40
V VenAcc (option) 5-40 Venous occlusion clamp, removing and installing 10-42 Venous pressure measurement 4-22 Vent valve of CDS block 10-80 Verification procedure in case of ingress of blood or fluid via the pressure line 10-44
W Warning symbol, significance 2-2 Warnings – relating to electricity 2-4 Water drain 4-11 Weight of the hemodialysis system 4-1 Wireless (option) 5-12 Working on the hemodialysis system 2-3 Wrench torques 10-13
Z Zero point of the pressure transducers (EBM), resetting 10-43
USER SETUP – Alarm processing 5-27 – Anticoagulation 5-16 – Auto On 5-32 – Blood lines 5-15 – Blood pump 5-15 – BPM (option) 5-39 – BTM (option) 5-39 – Cleaning 5-31 – Dialysate 5-18
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Chapter 2: Important information
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 initial study (to acquire a basic knowledge) and for reference purposes (for Technical Service Checks, maintenance procedures and repairs). The document does not replace the training courses offered by the manufacturer.
Identification
The document can be identified by the following information on the title page and on the labels, if any: – Document edition – Document part number
Footer
The footer displays the following information: – Company name – Device type – The English abbreviation for the document type and the international abbreviation for the document language, e.g., SM-EN means Service Manual in English. – The edition identification, for example, 4A-2013 refers to edition 4A released in 2013 – The page identification, for example, 1-3 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 marked accordingly.
Styles used in the document
The following text styles may be used in the document: Style
Description
Keys and buttons
Keys and buttons on the device are shown in bold type. Example: Example button.
Message text
Device messages are shown in italic type. Example: Message: Example of a message.
Instruction
Instructions are indicated by an arrow . Instructions must be followed. Example: Carry out instruction.
1. Numbered instruction 2. ... 3. ...
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Long passages containing instructions can be shown as numbered lists. Instructions must be followed. Example: 1. Carry out instruction.
2-1
Chapter 2: Important information
2.2
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 documents will be released as new editions or supplements. In general, this manual is subject to change without notice.
Reproduction
Reproduction, even in part, is only permitted with written approval.
Significance of warnings Warning Advises the operator that failure to observe this information can result in personal injury.
2.3
Significance of notes Note Advises the operator that failure to observe this information can – cause damage to the device. – result in a specific function not being executed at all or not being executed correctly.
2.4
Significance of tips Tip Information providing useful tips for easy handling.
2-2
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Chapter 2: Important information
2.5
Precautions for working on the hemodialysis system Requirements
Knowledge of the current Instructions for Use of the respective device. Background experience in mechanical, electrical and medical engineering.
Authorized persons
Start-up, extensions, adjustments, calibrations, maintenance procedures, modifications or repairs must only be carried out by the manufacturer or persons authorized by the manufacturer.
Test equipment and accessories
The activities described in this document require the availability of the necessary technical test equipment and accessories.
Specifications
The information contained in the Specifications chapter must be observed.
Precautions
Before switching on the power, repair any visible damage. Before opening the hemodialysis system and when working on the open hemodialysis system, the following precautions must be observed: – Protect the components against ingress of fluids. – Do not touch live parts. – Plugs, connections and components must only be disconnected or connected when the device is switched off. – There is a risk of chemical burns and scalding when working on the hydraulics.
ESD precautions
When repairing the device and replacing spare parts, observe the relevant ESD precautions.
Monitor support arm
If the hemodialysis system needs to be placed in a horizontal position for servicing, the monitor support arm must be locked in place with the transport protection mechanism to prevent it from swiveling.
After working on the hemodialysis system
After work has been carried out on the hemodialysis system, a disinfection, a T1 test and an electrical safety check (see Electrical safety check on page 6-37) must be performed. Check that the current Instructions for Use are readily available at the point of operation of the hemodialysis system. Ensure the operator is given the necessary additional instructions on any changes made.
After stopping a disinfection program Warning The hemodialysis system must be disconnected from the water supply no later than 3 days after stopping a disinfection program or putting the system into preservation mode. When the system is recommissioned, check that the pressure of the water supply meets the prescribed minimum pressure. Spare parts
Fresenius Medical Care
Use only original spare parts. For identifying and ordering spare parts, test equipment and tools, always use the electronic spare parts catalog.
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Chapter 2: Important information
2.6
Warnings
2.6.1
Warnings relating to electricity
Warning Risk of injury from electrical voltage. Touching live parts will cause an electric shock. Unplug the power plug before opening the hemodialysis system. Simply using the On / Off button to switch off the device does not disconnect the device from the power supply!
2.7
Addresses Manufacturer
Fresenius Medical Care AG & Co. KGaA 61346 Bad Homburg Germany Phone: +49 6172 609-0 www.fmc-ag.com
Service support, international
Fresenius Medical Care Deutschland GmbH Service Support International Hafenstraße 9 97424 Schweinfurt Germany Phone: +49 9721 678-333 (hotline) Fax: +49 9721 678-130
Service support, local
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Chapter 3: Installation
3
Installation
3.1
Initial start-up
3.1.1
Important information on initial start-up Precautions for working on the hemodialysis system
Before working on the hemodialysis system, first read the information in the relevant chapter (see Chapter 2.5 on page 2-3).
For initial start-up only
The following information is only intended for the initial start-up. This information does not apply to recommissioning devices that have been decommissioned even temporarily. If the hemodialysis system is first put into service more than 30 months after delivery, the technical safety checks (TSC) and the maintenance procedures (MA) must be performed in addition to the start-up.
Environmental conditions
Variations in temperature during transport may cause water condensation on electrical parts. In the event of major variations in temperature, allow sufficient time for the system to adjust to the ambient temperature before start-up.
Qualification requirements of testers
The checks must be performed by the manufacturer's service support organization or a person authorized by them. The checks must be performed by personnel qualified to perform them correctly, based on their education, training, knowledge and experience. Furthermore, the persons performing the checks must be permitted to do so independently and without outside interference.
Technical safety checks (TSC)
The first TSC is required before the end of the 30th month following initial start-up after delivery from the factory. All further TSCs are required before the end of the 24th month following the last TSC performed. The completion of the technical safety checks must be entered in the medical device register.
Maintenance procedures (MA)
Fresenius Medical Care
5008S
SM-EN
The maintenance procedures (MA) are a recommendation of the manufacturer. The maintenance procedures help ensure trouble-free operation, and must be carried out for the first time before the end of the 30th month following initial start-up after delivery from the factory. All further maintenance procedures should be performed before the end of the 24th month following the last maintenance procedure performed.
15A-2014
3-1