Fresenius Medical
5008 Service Manual Part no F40003407 Sw Ver 4.58 Edition 18A-2016
Service Manual
440 Pages
![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 Considerations for working on the device... 2-3 2.6 2.6.1 Warnings ... 2-4 Warnings, electrical ... 2-4 2.7 Addresses ... 2-5 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 ... 3-7 3.2 Transporting the device... 3-28 3.3 3.3.1 3.3.2 3.3.3 3.3.4 Decommissioning... 3-30 Important information on decommissioning... 3-30 Accessories required for decommissioning ... 3-30 Decommissioning report and identification sheet ... 3-30 Explanatory notes for completing the decommissioning report and identification sheet ... 3-33 3.4 3.4.1 3.4.2 3.4.3 3.4.4 Decommissioning extension... 3-38 Important information on decommissioning extension ... 3-38 Accessories required for decommissioning extension... 3-38 Decommissioning extension report ... 3-38 Explanatory notes for completing the decommissioning extension report... 3-40 3.5 3.5.1 3.5.2 3.5.3 Recommissioning after decommissioning ... 3-42 Important information on recommissioning after decommissioning... 3-42 Recommissioning report after decommissioning... 3-42 Explanatory notes for completing the recommissioning report after decommissioning ... 3-44 3.6 3.6.1 Disposal... 3-48 Important information on disposal ... 3-48 Fresenius Medical Care 5008 SM-EN 18A-2016 iii](https://images.bioclinicalservices.com.au/pA2TbsS8t1YJ2qwHXd4Qq4iM/320w/Fresenius%20Medical%20-%205008%20Service%20Manual%20Part%20no%20F40003407%20Sw%20Ver%204.58%20Edition%2018A-2016.png)
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Page 1
5008 Service Manual Software version: 4.58 Edition: 18A-2016 Part no.: F40003407 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
Considerations for working on the device... 2-3
2.6 2.6.1
Warnings ... 2-4 Warnings, electrical ... 2-4
2.7
Addresses ... 2-5
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 ... 3-7
3.2
Transporting the device... 3-28
3.3 3.3.1 3.3.2 3.3.3 3.3.4
Decommissioning... 3-30 Important information on decommissioning... 3-30 Accessories required for decommissioning ... 3-30 Decommissioning report and identification sheet ... 3-30 Explanatory notes for completing the decommissioning report and identification sheet ... 3-33
3.4 3.4.1 3.4.2 3.4.3 3.4.4
Decommissioning extension... 3-38 Important information on decommissioning extension ... 3-38 Accessories required for decommissioning extension... 3-38 Decommissioning extension report ... 3-38 Explanatory notes for completing the decommissioning extension report... 3-40
3.5 3.5.1 3.5.2 3.5.3
Recommissioning after decommissioning ... 3-42 Important information on recommissioning after decommissioning... 3-42 Recommissioning report after decommissioning... 3-42 Explanatory notes for completing the recommissioning report after decommissioning ... 3-44
3.6 3.6.1
Disposal... 3-48 Important information on disposal ... 3-48
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4
5
iv
Specifications 4.1
Dimensions and weight... 4-1
4.2
Identification label (device marking)... 4-1
4.3
Electrical safety ... 4-2
4.4
Electrical power supply... 4-2
4.5
Fuses ... 4-3
4.6 4.6.1 4.6.2
Information on electromagnetic compatibility... 4-3 Minimum distances between radiation source and device ... 4-3 EMC guidance and manufacturer's declaration ... 4-5
4.7
Operating conditions... 4-8
4.8
Consumption and energy data ... 4-9
4.9
Storage conditions ... 4-9
4.10
External connection options ... 4-10
4.11
Operating programs ... 4-11
4.12
Dialysate circuit and safety systems ... 4-13
4.13
Extracorporeal blood circuit and safety systems... 4-16
4.14
DIASAFE®plus ... 4-18
4.15
OCM ... 4-18
4.16
ONLINEplus™ ... 4-19
4.17
Network... 4-20
4.18
Radio (option) - in monitor... 4-21
4.19
Single-Needle (option)... 4-21
4.20
VenAcc (option) monitoring unit... 4-22
4.21
BPM (option) ... 4-22
4.22
BTM (option)... 4-23
4.23
BVM (option) ... 4-23
4.24
Residual-current device* (option) ... 4-24
4.25
Materials used... 4-24
Setup / service program 5.1 5.1.1
SYSTEM menu ... 5-1 Parameters in the SYSTEM menu... 5-2
5.2 5.2.1 5.2.2 5.2.3 5.2.4
SETUP menu (Service setup) ... 5-3 Settings Hydraulics menu option ... 5-4 Settings EBM menu option... 5-5 Settings Air bubble detector menu option... 5-7 Define cleaning parameters menu option ... 5-8 5.2.4.1 Define cleaning parameters menu option (page 1) ... 5-8 5.2.4.2 Define cleaning parameters menu option (page 2) ... 5-8
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5.2.5 5.2.6 5.2.7 5.2.8 5.2.9 5.2.10 5.3 5.3.1 5.3.2 5.3.3 5.3.4
5.3.14 5.3.15 5.3.16 5.3.17 5.3.18 5.3.19 5.3.20 5.3.21
USER SETUP menu ... 5-15 Blood line menu option ... 5-16 Blood pump menu option... 5-16 Rinse / reinfusion volume menu option (only if preparation performed with NaCl solution)... 5-17 Anticoagulation menu option... 5-17 5.3.4.1 Define syringe types menu sub-item ... 5-18 Dialysate menu option ... 5-19 5.3.5.1 Define concentrates menu sub-item ... 5-20 5.3.5.2 New concentrate menu sub-item... 5-21 Ultrafiltration menu option ... 5-24 Alarm processing menu option ... 5-25 User interface menu option... 5-27 5.3.8.1 Graphics menu sub-item... 5-27 5.3.8.2 Define options menu sub-item ... 5-28 5.3.8.3 Define controls menu sub-item ... 5-28 Cleaning menu option... 5-29 Auto On menu option... 5-30 Emergency menu option (reaction after pressing the Emergency button) ... 5-31 Extended safety menu option ... 5-32 ONLINE menu option ... 5-32 5.3.13.1 Define dialyzers menu sub-item ... 5-34 OCM menu option ... 5-34 Single-Needle (option) menu option... 5-35 Miscellaneous menu option ... 5-35 BPM (option) menu option... 5-35 BTM (option) menu option... 5-36 BVM (option) menu option... 5-37 HD-PAED (option) menu option ... 5-38 VenAcc (option) menu option ... 5-38
5.4 5.4.1 5.4.2 5.4.3
APPLICATIONS menu ... 5-39 PatientCard menu option... 5-39 Training menu option... 5-40 Fluid sampling menu option with sampling set... 5-40
5.5
Service Software (Quick Guide) ... 5-42
5.3.5 5.3.6 5.3.7 5.3.8
5.3.9 5.3.10 5.3.11 5.3.12 5.3.13
6
Miscellaneous menu option ... 5-9 5.2.5.1 Installing additional languages ... 5-11 Network menu option... 5-12 5.2.6.1 Address parameter ... 5-13 BTM (option) menu option... 5-13 BVM (option) menu option... 5-13 Radio (option) menu option... 5-14 Software options menu option... 5-14
Technical safety checks / maintenance procedures 6.1
Important information on TSCs / MAs ... 6-1
6.2
Accessories required for the TSCs / MAs ... 6-2
6.3
TSC / MA report ... 6-2
6.4
Explanatory notes for completing the TSC / MA report ... 6-7
6.5
TSC report ... 6-44
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7
Error messages
8
Test equipment and accessories
9
Calibration / Adjustment 9.1
SERVICE menu ... 9-1
9.2 9.2.1
Flow diagram menu ... 9-2 Setting the max. water inflow... 9-2
9.3 9.3.1 9.3.2 9.3.3
CALIBRATE menu ... 9-3 Calibrate touch screen menu option ... 9-4 Pressure transducer (S03/S07/S15/S16) menu option ... 9-4 Degassing (A01/P01) menu option ... 9-4 9.3.3.1 Loading pressure test menu sub-item ... 9-5 9.3.3.2 Negative pressure test menu sub-item ... 9-5 9.3.3.3 Start calibration menu sub-item ... 9-5 Loading pump (A02/P02) menu option... 9-6 9.3.4.1 Loading pressure test menu sub-item ... 9-6 9.3.4.2 Start calibration menu sub-item ... 9-6 Flow pump (A03) menu option ... 9-7 Temperature (PT7/PT8/PT9) menu option ... 9-9 Conductivity (CD7/CD9) menu option ... 9-10 Volumes menu option ... 9-10 Blood leak menu option... 9-11 OCM menu option... 9-11 ECMP configuration menu option (eccentric membrane pumps)... 9-12
9.3.4 9.3.5 9.3.6 9.3.7 9.3.8 9.3.9 9.3.10 9.3.11 9.4 9.4.1
9.4.12
DIAGNOSTICS menu ... 9-13 Monitor – Info menu option ... 9-14 9.4.1.1 Checking the screen failure sensor ... 9-14 EBM – Info menu option ... 9-14 EBM – Sensors / actuators menu option... 9-14 EBM – Pneumatics menu option... 9-15 Hydraulics – Info menu option ... 9-16 Hydraulics – Flow diagram: Individual control menu option ... 9-16 Hydraulics – Test menu option ... 9-17 Power supply unit – Info menu option ... 9-18 Radio – Info (option) menu option ... 9-18 BPM – Info / Test (option) menu option... 9-19 BVM – Info / Sensors (option) menu option ... 9-19 9.4.11.1 Checking the BVM... 9-20 BTM – Info / Sensors (option) menu option ... 9-20
9.5
SETUP menu ... 9-21
9.6 9.6.1
MODULE menu... 9-21 Novram menu option... 9-21
9.7 9.7.1
VARIOUS menu... 9-21 Preservation menu option ... 9-22
9.8 9.8.1
UPDATE menu ... 9-22 Updating the software version in a replaced module... 9-22
9.4.2 9.4.3 9.4.4 9.4.5 9.4.6 9.4.7 9.4.8 9.4.9 9.4.10 9.4.11
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9.8.2 9.8.3 9.8.4
Updating the software version of the device with a new CF card ... 9-23 Updating the software version of the device with the PC Service Software 5008 ... 9-25 Software version of the operating system in the monitor (M1) ... 9-26
9.9
Remote maintenance ... 9-26
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 front view... 10-5 10.2.3.3 Right front 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 10.3.6 10.3.7 10.3.8 10.3.9
Basic procedures ... 10-9 Performing the T1 test ... 10-9 Performing the EBM T1 test ... 10-9 Measuring the protective earth resistance... 10-10 Measuring the device leakage current... 10-12 Laying the device on its back ... 10-15 Installing components with SNAPLOC attachments... 10-16 Fitting components with self-cutting screws ... 10-17 Closing and opening the tube clamp ... 10-17 Connecting the tubing to the adapter ... 10-19
10.4
Wrench torques ... 10-19
10.5
Tube clamps... 10-20
10.6 10.6.1 10.6.2 10.6.3 10.6.4 10.6.5 10.6.6 10.6.7 10.6.8 10.6.9 10.6.10 10.6.11 10.6.12 10.6.13 10.6.14 10.6.15
Housing ... 10-21 Removing and installing the IV pole ... 10-21 Removing and installing the shunt interlock ... 10-21 Removing and installing the microswitch in the installed shunt interlock ... 10-23 Removing and installing the shunt interlock mark ... 10-25 Removing and installing the dialyzer coupling... 10-25 Removing and installing the dialyzer holder ... 10-27 Removing and installing the blood pressure monitor (BPM) (option) ... 10-28 Media supply rail – opening and closing the cover... 10-29 Opening and closing the hydraulics front doors ... 10-31 Removing and installing the hydraulics front door on the right... 10-31 Removing and installing the hydraulics front door on the left ... 10-33 Opening and closing the service doors ... 10-34 Removing and installing the service door on the right... 10-35 Removing and installing the service door on the left ... 10-38 Removing and installing the housing main part... 10-39
10.7 10.7.1 10.7.2
Trolley... 10-44 Removing and installing the concentrate rack... 10-44 Trolley with four braked rollers ... 10-45 10.7.2.1 Removing and installing the swivel rollers ... 10-45 10.7.2.2 Removing and installing the pedals with shaft ... 10-47
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10.7.3
10.7.2.3 Removing and installing the brake shaft ... 10-48 Trolley with two braked rollers ... 10-49 10.7.3.1 Removing and installing the rear swivel rollers ... 10-49 10.7.3.2 Removing and installing the brake engagement ... 10-49 10.7.3.3 Adjusting the brake... 10-51
10.8 10.8.1
Rechargeable battery ... 10-52 Removing and installing the battery pack ... 10-52
10.9 10.9.1 10.9.2 10.9.3 10.9.4
Monitor... 10-53 Removing and installing the monitor and the monitor support arm ... 10-53 Adjusting monitor movements ... 10-55 Transport protection for monitor support arm ... 10-58 Removing and installing the monitor front with touch / display unit and rear part... 10-59
10.10 10.10.1 10.10.2 10.10.3
Power supply unit and power cable... 10-62 Removing and installing the power cable ... 10-62 Removing and installing the power supply unit... 10-62 Removing and installing the power plug fuse (UK version only)... 10-64
10.11 Extracorporeal Blood Circuit Module (EBM)... 10-65 10.11.1 Removing and installing the EBM doors... 10-65 10.11.2 Opening and closing the EBM ... 10-66 10.11.3 Removing and installing the EBM... 10-67 10.11.4 Replacing the pneumatic tubings in the EBM ... 10-69 10.11.5 Removing and installing the arterial pressure measurement unit... 10-71 10.11.6 Removing and installing the venous and arterial occlusion clamp ... 10-71 10.11.7 Resetting the zero point of the pressure transducers (EBM)... 10-73 10.11.8 Verification / repair procedure in case of ingress of blood or fluid via the pressure line... 10-75 10.11.9 Checking the pneumatics of the arterial pressure measurement unit... 10-77 10.11.10 Checking the venous pressure transducer for leakage ... 10-78 10.11.11 Checking the Single-Needle pressure transducer with compliance chamber for leakage... 10-79 10.11.12 Removing and installing the catch of the occlusion clamps... 10-80 10.11.13 Removing and installing the air bubble detector (ABD) ... 10-81 10.11.14 Removing and installing the heparin pump stock ... 10-82 10.11.15 Removing and installing the heparin pump length sensor ... 10-83 10.11.16 Removing and installing the heparin pump... 10-85 10.11.17 Removing and installing the level detector ... 10-90 10.11.18 Removing and installing the online module ... 10-91 10.11.19 Removing and installing the blood temperature monitor (BTM) (option) ... 10-93 10.11.20 Removing and installing the blood volume monitor (BVM) (option)... 10-94 10.12 Hydraulics ... 10-96 10.12.1 Removing and installing the pressure reducing valve A04, water inlet... 10-96 10.12.2 Removing and installing the heat exchanger... 10-98 10.12.3 Removing and installing the float switch S01 of the water inlet chamber ... 10-101 10.12.4 Removing and installing the degassing orifice... 10-103 10.12.5 Removing and installing the heater rod ... 10-104 10.12.6 Removing and installing the concentrate pump... 10-105 10.12.7 Removing and installing the bicarbonate pump... 10-107 10.12.8 Removing and installing the UF pump... 10-108 10.12.9 Removing and installing the gear pump drive... 10-109 10.12.10 Removing and installing the gear pump ... 10-110 10.12.11 Removing and installing the balancing chamber ... 10-111 10.12.12 Removing and installing the blood leak detector ... 10-113 10.12.13 Removing and installing the flap lid ... 10-115 10.12.14 Removing and installing the bibag® connector... 10-116 10.12.15 Removing and installing the concentrate rinse chamber ... 10-117
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10.12.16 Removing and installing the bicarbonate rinse chamber... 10-118 10.12.17 Removing and installing the CDS block ... 10-120 10.12.17.1 Vent valve of CDS block ... 10-121 10.12.18 Temperature and conductivity sensors, calibration after replacement ... 10-122 10.12.19 Disinfectant valves (yellow labels) V20 and V34 ... 10-123 10.12.20 Deactivating the Flush function ... 10-126 10.12.21 Removing and installing the dosing chamber... 10-128 10.12.22 Removing and installing the float switch S02 of the mixing chamber ... 10-130 10.12.23 Removing the covers of PCBs LP 1123, LP 1124 and LP 1125 ... 10-132 10.12.24 Removing and installing the pressure pad ... 10-133 10.13
Checking the network interface ... 10-134
10.14 Printed circuit boards ... 10-136 10.14.1 PCB LP 1102 Controller board (C167) ... 10-136 10.14.2 PCB LP 1103 External interface unit ... 10-139 10.14.3 PCB LP 1104 Monitor power supply board ... 10-144 10.14.4 PCB LP 1105 Power supply CPU... 10-147 10.14.5 PCB LP 1106 Power supply distribution board... 10-149 10.14.6 PCB LP 1107-4 EBM I/O board... 10-151 10.14.7 PCB LP 1108-3 Hydraulics actuators ... 10-156 10.14.8 PCB LP 1109 Hydraulics sensors OS ... 10-159 10.14.9 PCB LP 1110 Hydraulics sensors SS... 10-162 10.14.10 PCB LP 1113 Hydraulics valve control board... 10-165 10.14.11 PCB LP 1123 Hydraulics distribution board, door left ... 10-166 10.14.12 PCB LP 1124 Hydraulics distribution board, front ... 10-168 10.14.13 PCB LP 1125 Hydraulics distribution board, door right ... 10-170 10.14.14 PCB LP 1126 Heparin pump control board ... 10-172 10.14.15 PCB LP 1129 Monitor distribution board ... 10-173 10.14.16 PCB LP 1131 Monitor operating mode indicator ... 10-174 10.14.17 PCB LP 1131-2 Monitor operating mode indicator with wireless module... 10-175 10.14.18 PCB LP 1132 Key LED board ... 10-176 10.14.19 PCB LP 1134 Monitor card reader ... 10-177 10.14.20 PCB LP 1139 Screen failure sensor... 10-178 10.14.21 PCB LP 1144 EBM door sensor ... 10-179 10.14.22 PCB LP 1148 Monitor distribution board ... 10-180 10.14.23 PCB LP 1202 Controller board (C167) ... 10-183 10.14.23.1 Combination of PCB LP 1202 with PCBs LP 1107 / LP 1108... 10-185 10.14.24 PC board ... 10-186 10.15 Troubleshooting ... 10-188 10.15.1 Troubleshooting with dark display ... 10-188 10.15.2 Troubleshooting in case of unclear crashes and suspected CAN bus problems ... 10-191
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
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11.7
Hydraulics (block diagram / description) ... 11-12
11.8
Hydraulics (flow diagram, legend, description)... 11-14
12 Appendix
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Chapter 1: Index
1
Index
A
Battery pack, removing and installing 10-52
Accessories and test equipment 8-1
bibag® connector – switch position 10-166
Accessories required – Decommissioning 3-30 – Decommissioning extension 3-38 – TSC / MA 6-2
bibag® connector, removing and installing 10-116 Bicarbonate pump, removing and installing 10-107 Bicarbonate rinse chamber, removing and installing 10-118
Addresses 2-5 Adjusting monitor movements 10-55
Block diagrams – EBM 11-7 – Hydraulics 11-12 – Monitor 11-3 – Pneumatics 11-8 – Power supply unit 11-5
Adjusting the brake (two braked rollers) 10-51 Adjustment 9-1 Air bubble detector 4-17 Air bubble detector (ABD), removing and installing 10-81 Alarm output 4-11 Antifreeze 4-10 APPLICATIONS menu 5-39 – PatientCard 5-39 – Sampling 5-40 – Training 5-40
Central delivery system (option) 4-8
Blood pressure monitor (BPM) 4-22
Checking the BVM (option) 9-20
Arterial occlusion clamp, removing and installing 10-71
Blood temperature monitor (BTM) (option), removing and installing 10-93 Blood volume monitor (BVM) (option), removing and installing 10-94 BPM (option) 4-22 – BPM version 6-31 – BPM2 version 6-31
Audible alarm 4-18
Catch of the occlusion clamps, removing and installing 10-80
Blood leak detector, removing and installing 10-113
Blood pump 4-16
Atmospheric pressure 4-8
Calibration 9-1
CDS block, removing and installing 10-120
AquaUNO / AquaC UNO H 4-11
Arterial pressure measurement unit, removing and installing 10-71
Blood leak 9-11 Calibrate touch screen 9-4 Conductivity (CD7/CD9) 9-10 Degassing (A01/P01) 9-4 ECMP configuration 9-12 Flow pump (A03) 9-7 Loading pump (A02/P02) 9-6 OCM 9-11 Pressure transducer (S03/S07/S15/S16) 9-4 – Temperature (PT7/PT8/PT9) 9-9 – Volumes 9-10
Blood leak detector 4-13
Blood pressure monitor (BPM) (option), removing and installing 10-28
Arterial pressure measurement 4-16
– – – – – – – – –
Checking the pneumatics of the arterial pressure measurement unit 10-77 Checking the Single-Needle pressure transducer with compliance chamber for leakage (option) 10-79 Checking the venous pressure transducer for leakage 10-78 Circulation 4-12 Cleaning programs 4-12 Closing plugs 8-5
BPM2 version 6-31
Component overview – EBM 10-3 – Hydraulics 10-4 – Monitor 10-2
B
Brake engagement, removing and installing 10-49
Concentrate pump, removing and installing 10-105
Balancing chamber, removing and installing 10-111
Brake shaft, removing and installing 10-48
Concentrate rack, removing and installing 10-44
Basic procedures 10-9
BTM (option) 4-23
Batteries – PC board 10-187 – PCB LP1105 10-148 – TSC / MA 6-24 – VenAcc (option) 4-22, 9-19
BVM (option) 4-23 – Checking 9-20
Concentrate rinse chamber, removing and installing 10-117
Authorized persons 2-3
BPM version 6-31
AutoFlow 4-15
Concentration of disinfectant 4-16
C CALIBRATE menu 9-3
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Conductivity sensors – Calibration after replacement
1-1
Chapter 1: Index
Dimensions of the device 4-1
External connection options 4-10
Connecting the tubing to the adapter 10-19
Disinfectant valves V20 and V34 (yellow labels) 10-123
Extracorporeal Blood Circuit Module EBM 10-65
Considerations for working on the device 2-3
Disposal – Important information 3-48
Consumption data 4-9 Converting g/l to mmol/l 5-24
Dosing chamber, removing and installing 10-128
D
E
Deactivating Flush (option) 10-126
EBM – Block diagram 11-7 – Description 11-8 – Doors, removing and installing 10-65 – Opening and closing 10-66 – Removing and installing 10-67 – Zero point of the pressure transducers, resetting 10-73
10-122
Decommissioning 9-22 – Accessories required 3-30 – Explanatory notes for completing the report 3-33 – Identification sheet 3-32 – Important information 3-30 – Report 3-31 Decommissioning extension – Accessories required 3-38 – Explanatory notes for completing the report 3-40 – Important information 3-38 – Report 3-39 Degassing orifice, removing and installing 10-103 Descriptions – EBM 11-8 – Hydraulics 11-13, 11-17 – Monitor 11-4 – Pneumatics 11-9 – Power supply unit 11-6 Device, tilting 10-15 DIAGNOSTICS menu 9-13 – BPM – Info / Test (option) 9-19 – BTM – Info / Sensors (option) 9-20 – BVM – Info / Sensors (option) 9-19 – EBM – Info 9-14 – EBM – Pneumatics 9-15 – EBM – Sensors / actuators 9-14 – Hydraulics – Flow diagram Individual control 9-16 – Hydraulics – Info 9-16 – Hydraulics – Test 9-17 – Monitor – Info 9-14 – Power supply unit – Info 9-18 – Radio – Info (option) 9-18 Dialyzer coupling, removing and installing 10-25 DIASAFE®plus 4-18
1-2
F Final tasks after working on the device 2-3 Flap lid, removing and installing 10-115
EcoFlow 4-15 Electrical power supply 4-2 Electrical safety 4-2, 6-37 – Measuring the device leakage current 10-12 – Measuring the protective earth resistance 10-10 Electrical safety check 6-37 Electromagnetic compatibility (EMC) 4-3 EMC – Electromagnetic compatibility 4-3 – Electromagnetic emissions 4-5 – Electromagnetic immunity 4-5 – Guidance and manufacturer's declaration 4-5 – Minimum distances between radiation source and device 4-3 – Recommended separation distances 4-7 Energy data 4-9
Float switch S01 of the water inlet chamber, removing and installing 10-101 Float switch S02 of the mixing chamber, removing and installing 10-130 Flow diagram 11-14 – Description 11-17 – Legend 11-15 Flow diagram menu 9-2 Flush (option) 4-13, 10-126 Functional description 11-1 Fuses – PCB LP1103 10-141 – PCB LP1104 10-145, 10-190 – PCB LP1106 10-4, 10-150 – PCB LP1107-4 10-154 – PCB LP1113 10-165 – Power plug, UK version 10-64 – Power switch 4-3 – Rechargeable battery 4-3, 10-8 – TSC / MA 6-7, 6-37
G Gear pump drive, removing and installing 10-109 Gear pump, removing and installing 10-110
H
Error messages 7-1 ESD precautions 2-3 Explanatory notes – Decommissioning extension report 3-40 – Decommissioning report 3-33 – Identification sheet 3-33 – Initial start-up report 3-7 – Recommissioning report after decommissioning 3-44 – TSC report 6-7 – TSC/MA report 6-7
Heat exchanger, removing and installing 10-98 Heater rod, removing and installing 10-104 Heparin pump 4-17 Heparin pump length sensor, removing and installing 10-83 Heparin pump stock, removing and installing 10-82
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Chapter 1: Index
Heparin pump, removing and installing 10-85 Home dialysis 3-2 Home healthcare environment 3-2 Housing 10-21 Housing main part, removing and installing 10-39 How to use the Service Manual 2-1 Hydraulics 10-96 – Block diagram 11-12 – Description 11-13, 11-17 – Flow diagram 11-14 Hydraulics front door, left, removing and installing 10-33 Hydraulics front door, right, removing and installing 10-31
I Identification label 4-1 Illustrations 2-2 Important information 2-1 – Decommissioning 3-30 – Decommissioning extension 3-38 – Disposal 3-48 – Initial start-up 3-1 – Operation in a domestic environment 3-2 – Recommissioning after decommissioning 3-42 – Repair 10-1 – Servicing 10-1 – TSC 6-1 – TSC / MA 6-1 Inclination during operation 4-8 Ingress of blood or fluid via the pressure line 10-75 Initial start-up – Explanatory notes 3-7 – Important information 3-1 – Operation in a domestic environment 3-2 – Report 3-3 Installation altitude 4-8 IV pole 4-8
PCB LP1104 10-145 PCB LP1108-3 10-157 PCB LP1109 10-160 PCB LP1123 10-166 PCB LP1129 10-173 PCB LP1148 10-180
L LAN 4-10 Laying the device on its back 10-15 LEDs – PCB LP1102 10-137 – PCB LP1104 10-145, 10-190 – PCB LP1105 10-148 – PCB LP1107-4 10-154 – PCB LP1108-3 10-158 – PCB LP1124 10-168 – PCB LP1131 10-174 – PCB LP1131-2 (wireless module) 10-175 – PCB LP1132 10-176 – PCB LP1202 10-184 Level detector, removing and installing 10-90
M
5008
N Network 4-20
Note symbol, significance 2-2
O OCM 4-18 Online module, removing and installing 10-91 ONLINEplus™ 4-19 Opening and closing the hydraulics front doors 10-31 Opening and closing the service doors 10-34 Operating conditions 4-8 Operating programs 4-11 Operating temperature range 4-8 Operation in the home healthcare environment – important information 3-2 Optical detector 4-17
Maintenance procedures (MA) 6-1 Manufacturer 2-5 Materials 4-24, 4-27 Materials used 4-24 Measuring the device leakage current 10-12 Measuring the protective earth resistance 10-10 Media supply rail – opening and closing the cover 10-29 MODULE menu 9-21 – Novram 9-21 Monitor 10-53 – Block diagram 11-3 – Description 11-4 Monitor compatibility matrix 10-181
Monitor operating system (M1) 9-26
Jumpers – PCB LP1102 10-137 – PCB LP1103 10-141
Monitor with monitor support arm, removing and installing 10-53
Network interface, checking 10-134
Monitor front with touch/display unit and rear part, removing and installing 10-59
J
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P PC board – Battery 10-187 – Calibration after replacement 10-187 – Installation location 10-187 – Required tests 10-187 PCB covers 10-132 PCB LP1102 – Calibration after replacement 10-138 – Connectors 10-137 – Installation location 10-137 – Jumpers 10-137 – LEDs 10-137 – Required tests 10-138 PCB LP1103 – Calibration after replacement 10-143 – Fuses 10-141 – Installation location 10-140 – Jumpers 10-141 – Potentiometers 10-143
1-3
Chapter 1: Index
– Required tests 10-143
– Required tests 10-165
PCB LP1104 – Calibration after replacement 10-146 – Fuses 10-145 – Installation location 10-144 – Jumpers 10-145 – LEDs 10-145 – Required tests 10-146 – Solder bridges 10-145
PCB LP1123 – Calibration after replacement 10-166 – Installation location 10-166 – Jumpers 10-166 – Required tests 10-166 – Solder bridges 10-166
PCB LP1105 – Battery 10-148 – Calibration after replacement 10-148 – Installation location 10-148 – LEDs 10-148 – Required tests 10-148 PCB LP1106 – Calibration after replacement 10-150 – Fuses 10-150 – Installation location 10-149 – Required tests 10-150 PCB LP1107-4 – Calibration after replacement 10-154 – Fuses 10-154 – Installation location 10-153 – LEDs 10-154 – Required tests 10-154 PCB LP1108-3 – Calibration after replacement 10-158 – Installation location 10-157 – Jumpers 10-157 – LEDs 10-158 – Required tests 10-158 PCB LP1109 – Calibration after replacement 10-161 – Installation location 10-160 – Jumpers 10-160 – Required tests 10-161 – Solder bridges 10-160 PCB LP1110 – Calibration after replacement 10-163 – Installation location 10-163 – Required tests 10-163 PCB LP1113 – Calibration after replacement 10-165 – Fuses 10-165 – Installation location 10-165
1-4
PCB LP1124 – Calibration after replacement 10-168 – Installation location 10-168 – Jumpers 10-168 – LEDs 10-168 – Required tests 10-169 – Solder bridges 10-168 PCB LP1125 – Calibration after replacement 10-170 – Installation location 10-170 – Jumpers 10-170 – Required tests 10-170 – Solder bridges 10-170 PCB LP1126 – Calibration after replacement 10-172 – Installation location 10-172 – Required tests 10-172 PCB LP1129 – Calibration after replacement 10-173 – Installation location 10-173 – Jumpers 10-173 – Required tests 10-173 PCB LP1131 – Calibration after replacement 10-174 – Installation location 10-174 – LEDs 10-174 – Required tests 10-174 PCB LP1131-2 – Calibration after replacement 10-175 – Installation location 10-175 – LEDs 10-175 – Required tests 10-175 PCB LP1132 – Calibration after replacement 10-176 – Installation location 10-176 – LEDs 10-176 – Required tests 10-176 PCB LP1134 – Calibration after replacement
10-177 – Installation location 10-177 – Required tests 10-177 PCB LP1139 – Calibration after replacement 10-178 – Installation location 10-178 – Required tests 10-178 PCB LP1144 – Calibration after replacement 10-179 – Installation location 10-179 – Required tests 10-179 PCB LP1148 – Calibration after replacement 10-182 – Installation location 10-180 – Jumpers 10-180 – Monitor compatibility matrix 10-181 – Required tests 10-182 – Solder bridges 10-180 PCB LP1202 – Calibration after replacement 10-184 – Installation location 10-183 – LEDs 10-184 – Required tests 10-184 PCBs, overview 11-2 Pedals with shaft, removing and installing 10-47 Performing the EBM T1 test 10-9 Performing the T1 test 10-9 Pneumatic tubings in the EBM, replacing 10-69 Pneumatics – Block diagram 11-8 – Control states 11-10 – Description 11-9 Power cable, removing and installing 10-62 Power plug fuse (UK version only), removing and installing 10-64 Power supply unit – Block diagram 11-5 – Description 11-6 Power supply unit, removing and installing 10-62 Precautions 2-3 Preparation 4-11 Pressure holding test 4-14
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Chapter 1: Index
Pressure pad, removing and installing 10-133 Pressure reducing valve A04, water inlet, removing and installing 10-96 Priming and rinsing 4-11 Printed circuit boards – Combination, PCB LP 1202 with PCBs LP 1107 / LP 1108 10-185 – PC board 10-186 – PCB LP1102 10-136 – PCB LP1103 10-139 – PCB LP1104 10-144 – PCB LP1105 10-147 – PCB LP1106 10-149 – PCB LP1107-4 with attached PCB LP1158 10-151 – PCB LP1107-4 with integrated PCB LP1158 10-152 – PCB LP1108-3 10-156 – PCB LP1109 10-159 – PCB LP1110 10-162 – PCB LP1113 10-165 – PCB LP1123 10-166 – PCB LP1124 10-168 – PCB LP1125 10-170 – PCB LP1126 10-172 – PCB LP1129 10-173 – PCB LP1131 10-174 – PCB LP1131-2 (wireless module) 10-175 – PCB LP1132 10-176 – PCB LP1134 10-177 – PCB LP1139 10-178 – PCB LP1144 10-179 – PCB LP1148 10-180 – PCB LP1202 10-183 – PCBs, overview 11-2 Pulse 4-22
Q Quick Guide – Service Software 5-42
R Rear swivel rollers, removing and installing 10-49 Rechargeable battery – Decommissioning 3-32 – Fuse 4-3 – Maintenance 4-10 – Removing and installing 10-52
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– Specifications 4-2 – TSC / MA 6-24 – Voltage 4-2, 9-18 Recommissioning after decommissioning – Explanatory notes for completing the report 3-44 – Important information 3-42 – Report 3-43 Reinfusion 4-12 Relative humidity 4-8 Relocating a device used in a home healthcare environment 3-2 Remote maintenance 9-26 Removing and installing – Air bubble detector (ABD) 10-81 – Arterial occlusion clamp 10-71 – Arterial pressure measurement unit 10-71 – Balancing chamber 10-111 – Battery pack 10-52 – bibag® connector 10-116 – Bicarbonate pump 10-107 – Bicarbonate rinse chamber 10-118 – Blood leak detector 10-113 – Blood pressure monitor (BPM) (option) 10-28 – Blood temperature monitor (BTM) (option) 10-93 – Blood volume monitor (BVM) (option) 10-94 – Brake engagement (two braked rollers) 10-49 – Brake shaft (four braked rollers) 10-48 – Catch of the occlusion clamps 10-80 – CDS block 10-120 – Concentrate pump 10-105 – Concentrate rack 10-44 – Concentrate rinse chamber 10-117 – Conductivity sensors 10-122 – Degassing orifice 10-103 – Dialyzer coupling 10-25 – Dialyzer holder 10-27 – Disinfectant valve V20 (yellow label) 10-123 – Disinfectant valve V34 (yellow label) 10-123 – Dosing chamber 10-128 – EBM 10-67 – EBM doors 10-65
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– – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – –
Flap lid 10-115 Float switch S01 10-101 Float switch S02 10-130 Gear pump 10-110 Gear pump drive 10-109 Heat exchanger 10-98 Heater rod 10-104 Heparin pump 10-85 Heparin pump length sensor 10-83 Heparin pump stock 10-82 Housing, main part 10-39 Hydraulics front door, left 10-33 Hydraulics front door, right 10-31 IV pole 10-21 Level detector 10-90 Monitor front with touch/display unit 10-59 Monitor with monitor support arm 10-53 Online module 10-91 PCB covers 10-132 Pedals with shaft (four braked rollers) 10-47 Pneumatic tubings in the EBM 10-69 Power cable 10-62 Power plug fuse (UK version only) 10-64 Power supply unit 10-62 Pressure pad 10-133 Pressure reducing valve A04 10-96 Rear swivel rollers (two braked rollers) 10-49 Service door, left 10-38 Service door, right 10-35 Shunt interlock 10-21 Shunt interlock mark 10-25 Shunt interlock microswitch 10-23 Swivel rollers (four braked rollers) 10-45 Temperature sensors 10-122 UF pump 10-108 Venous occlusion clamp 10-71
Removing and installing the dialyzer holder 10-27 Removing and installing the IV pole 10-21 Removing and installing the microswitch in the installed shunt interlock 10-23
1-5
Chapter 1: Index
Removing and installing the shunt interlock 10-21
Single-Needle chamber (option) 4-21
Transporting a device used in a home healthcare environment 3-2
Removing and installing the shunt interlock mark 10-25
Single-Needle Click-Clack 4-18
Treatment 4-11
SNAPLOC attachment 10-16
Trolley 10-44
Repair procedure in case of ingress of blood or fluid via the pressure line 10-75
Software version of the operating system in the monitor (M1) 9-26
Trolley with four braked rollers 10-45
Software version update 9-22 – in a replaced module 9-22 – with a new CF card 9-23 – with the PC Service Software 5008 9-25
Trolley with two braked rollers 10-49
Solder bridges – PCB LP1104 10-145 – PCB LP1109 10-160 – PCB LP1123 10-166 – PCB LP1124 10-168 – PCB LP1125 10-170 – PCB LP1148 10-180
Troubleshooting with dark display 10-188
Reports – Decommissioning 3-31 – Decommissioning extension 3-39 – Identification sheet (decommissioning) 3-32 – Initial start-up 3-3 – Recommissioning after decommissioning 3-43 – TSC 6-45 – TSC / MA 6-3 Residual-current device 4-24 Rinse and disinfection flow 4-16
S Self-cutting screws 10-17
Spare parts 2-3 Specifications 4-1 Stability 4-8 Stationary equipment 3-2
Troubleshooting in case of unclear crashes and suspected CAN bus problems 10-191
TSC – Accessories required 6-2 – Explanatory notes for completing the report 6-7 – Important information 6-1 – Report 6-45 TSC / MA – Accessories required 6-2 – Explanatory notes for completing the report 6-7 – Important information 6-1 – Report 6-3
Service / diagnostics 4-11
Stopping a disinfection program 2-3
Service door, left, removing and installing 10-38
Styles used in the document 2-1
Service door, right, removing and installing 10-35
Closing and opening the tube clamp 10-17
Swivel rollers, removing and installing 10-45
Tube clamps 10-20
SERVICE menu 9-1 – CALIBRATE 9-3 – DIAGNOSTICS 9-13 – Flow diagram 9-2 – MODULE 9-21 – SETUP 5-3 – UPDATE 9-22 – VARIOUS 9-21
SYSTEM menu 5-1 – APPLICATIONS 5-39 – SERVICE 9-1 – USER SETUP 5-15
U
Storage conditions 4-9
UF pump, removing and installing 10-108 UFC measurement 4-14
T
Ultrafiltration 4-13
T1 test 4-11
UPDATE menu 9-22
Service Software – Quick Guide 5-42
Technical safety checks (TSCs) 6-1
Setting the max. water inflow 9-2
Temperature at water drain 4-8
SETUP menu (Service setup) 5-3 – BTM (option) 5-13 – BVM (option) 5-13 – Define cleaning parameters 5-8 – Miscellaneous 5-9 – Network 5-12 – Radio (option) 5-14 – Settings Air bubble detector 5-7 – Settings EBM 5-5 – Settings Hydraulics 5-4 – Software options 5-14
Temperature sensors – Calibration after replacement 10-122
USER SETUP menu 5-15 – Alarm processing 5-25 – Anticoagulation 5-17 – Auto On 5-30 – Blood lines 5-16 – Blood pump 5-16 – BPM (option) 5-35 – BTM (option) 5-36 – BVM (option) 5-37 – Cleaning 5-29 – Define concentrates 5-20 – Dialysate 5-19 – Emergency 5-31 – Extended safety 5-32 – HD-PAED (option) 5-38 – Miscellaneous 5-35 – New concentrate 5-21
Single-Needle (option) 4-21
1-6
Test equipment and accessories 8-1 Tilting tool 8-6 Tip symbol, significance 2-2 Transmembrane pressure 4-13 Transport protection for monitor support arm 10-58
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OCM 5-34 ONLINE 5-32 Rinse / reinfusion volume 5-17 Single-Needle (option) 5-35 Ultrafiltration 5-24 User interface 5-27 VenAcc (option) 5-38
V VARIOUS menu 9-21 – Preservation 9-22 Venous occlusion clamp, removing and installing 10-71 Venous pressure measurement 4-17 Vent valve of CDS block 10-121 Verification procedure in case of ingress of blood or fluid via the pressure line 10-75
W Warning symbol, significance 2-2 Warnings – relating to electricity 2-4 Water drain 4-8 Water inlet pressure 4-8 Water inlet rate 4-8 Water inlet temperature 4-8 Weight of the device 4-1 Working on the device 2-3 Wrench torques 10-19
Z Zero point of the pressure transducers (EBM), resetting 10-73
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Chapter 1: Index
1-8
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Chapter 2: Important information
2
Important information
2.1
How to use the Service Manual Device type
In this document, unless otherwise stated, the word "device" on its own always refers to the 5008 device.
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
Messages displayed by the device 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.
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Chapter 2: Important information
Style
Description
1. Numbered instruction
Long passages containing instructions can be shown as numbered lists. Instructions must be followed.
2. ... 3. ...
2.2
Example: 1. Carry out instruction.
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 result in the following: – Damage to the device – Required functions will not be executed at all or not 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
Considerations for working on the device 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 device and when working on the open device, 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 safety measures.
Monitor support arm
If the device 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 stopping a disinfection program Warning The device must be disconnected from the water supply no later than 3 days after stopping a disinfection program or putting it into preservation mode. When the system is recommissioned, check that the pressure of the water supply meets the prescribed minimum pressure. Spare parts
Use only original spare parts. For identifying and ordering spare parts, test equipment and tools, always use the electronic spare parts catalog.
After working on the device
Check that the current Instructions for Use are readily available at the point of operation of the device. Ensure the operator is given the necessary additional instructions on any changes made. There are certain final tasks to be performed after work has been carried out on the device. Depending on the type of work performed, one of more final tasks must be performed.
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