Fresenius Medical
5008 Service Manual Part no M54 221 1 Sw Ver 4.50 Edition 15A-2014
Service Manual
426 Pages
Preview
Page 1
5008 Service Manual Software version: 4.50 Edition: 15A-2014 Part no.: M54 221 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
Considerations 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... 3-32 Important information on decommissioning... 3-32 Accessories required for decommissioning ... 3-32 Decommissioning report and identification sheet ... 3-32 Explanatory notes for completing the decommissioning report and identification sheet ... 3-35
3.4 3.4.1 3.4.2 3.4.3 3.4.4
Decommissioning extension... 3-40 Important information on decommissioning extension ... 3-40 Accessories required for decommissioning extension... 3-40 Decommissioning extension report ... 3-40 Explanatory notes for completing the decommissioning extension report... 3-42
3.5 3.5.1 3.5.2 3.5.3
Recommissioning after decommissioning ... 3-44 Important information on recommissioning after decommissioning... 3-44 Recommissioning report after decommissioning... 3-44 Explanatory notes for completing the recommissioning report after decommissioning ... 3-46
3.6 3.6.1
Removal from service ... 3-50 Important information on removal from service ... 3-50
Fresenius Medical Care
5008
SM-EN
15A-2014
iii
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 ... 4-13
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... 4-29
4.22
Wireless (option) - in monitor... 4-30
4.23
Single-Needle (option)... 4-30
4.24
VenAcc (option) monitoring unit... 4-30
4.25
BPM (option) ... 4-31
4.26
BTM (option)... 4-31
4.27
BVM (option) ... 4-32
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
Fresenius Medical Care
5008
SM-EN
15A-2014
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 BVM (can only be selected if the system option is available)... 5-12 5.2.2.9 Radio (can only be selected if the system option is available) ... 5-13 5.2.2.10 Software options ... 5-13
5.3 5.3.1 5.3.2
USER SETUP... 5-15 USER SETUP – selecting / setting... 5-15 USER SETUP – overview ... 5-16 5.3.2.1 Blood line ... 5-16 5.3.2.2 Blood pump ... 5-16 5.3.2.3 Rinse / reinfusion volume (only when prepared with NaCl solution) ... 5-16 5.3.2.4 Anticoagulation... 5-17 5.3.2.5 Dialysate ... 5-19 5.3.2.6 Ultrafiltration ... 5-28 5.3.2.7 Alarm processing... 5-28 5.3.2.8 User interface ... 5-31 5.3.2.9 Cleaning ... 5-34 5.3.2.10 Auto On ... 5-34 5.3.2.11 Emergency (reaction after pressing the Emergency button) ... 5-37 5.3.2.12 Extended safety ... 5-38 5.3.2.13 ONLINE ... 5-38 5.3.2.14 OCM ... 5-41 5.3.2.15 Single-Needle (can only be selected if the system option is available)... 5-41 5.3.2.16 Miscellaneous ... 5-42 5.3.2.17 BPM (can only be selected if the system option is available)... 5-42 5.3.2.18 BTM (can only be selected if the system option is available)... 5-43 5.3.2.19 BVM (can only be selected if the system option is available)... 5-44 5.3.2.20 HD-PAED (can only be selected if the system option is available) ... 5-45 5.3.2.21 VenAcc (can only be selected if the system option is available) ... 5-46
5.4 5.4.1 5.4.2
APPLICATIONS... 5-47 APPLICATIONS – selecting / setting... 5-47 APPLICATIONS – overview ... 5-47 5.4.2.1 PatientCard ... 5-47 5.4.2.2 Training ... 5-48 5.4.2.3 Fluid sampling with sampling set... 5-48
5.5
Service Software (Quick Guide) ... 5-50
Technical safety checks / maintenance procedures 6.1
Important information on TSCs / MAs ... 6-1
6.2
Accessories required for the TSCs / MAs ... 6-2
Fresenius Medical Care
5008
SM-EN
15A-2014
v
6.3
TSC / MA report... 6-2
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 (A01/P01) ... 9-4 9.3.1.4 Loading pump (A02/P02) ... 9-5 9.3.1.5 Flow pump (A03) ... 9-7 9.3.1.6 Temperature (PT7/PT8/PT9)... 9-8 9.3.1.7 Conductivity (CD7/CD9) ... 9-9 9.3.1.8 Volumes ... 9-10 9.3.1.9 Blood leak... 9-10 9.3.1.10 OCM ... 9-10 9.3.1.11 ECMP configuration (eccentric membrane pumps)... 9-11
9.4 9.4.1
DIAGNOSTICS... 9-12 DIAGNOSTICS – overview... 9-12 9.4.1.1 Monitor ... 9-12 9.4.1.2 EBM... 9-12 9.4.1.3 Hydraulics... 9-14 9.4.1.4 Power supply unit ... 9-16 9.4.1.5 Radio (option) ... 9-16 9.4.1.6 BPM (option) ... 9-17 9.4.1.7 BVM (option) ... 9-18 9.4.1.8 BTM (option)... 9-19
9.5
SETUP... 9-19
Fresenius Medical Care
5008
SM-EN
15A-2014
9.6 9.6.1
MODULE ... 9-19 MODULE – overview ... 9-19 9.6.1.1 Novram... 9-19
9.7
VARIOUS ... 9-19
9.8 9.8.1 9.8.2 9.8.3
UPDATE... 9-20 Updating the software version in a replaced module... 9-20 Updating the software version of the hemodialysis system with a new CF card ... 9-21 Updating the software version of the hemodialysis system with the 5008 PC Service Software ... 9-22
9.9
Remote maintenance ... 9-23
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
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 10.5.10 10.5.11 10.5.12 10.5.13 10.5.14
Housing ... 10-13 Removing and installing the IV pole ... 10-13 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 ... 10-18 Removing and installing the blood pressure monitor (BPM) (option) ... 10-19 Media supply rail – opening and closing the cover... 10-19 Opening the hydraulics front doors... 10-21 Removing and installing the hydraulics front door on the right... 10-21 Removing and installing the hydraulics front door on the left ... 10-23 Removing and installing the service door on the right... 10-24 Removing and installing the service door on the left ... 10-27 Removing and installing the housing main part... 10-28
10.6 10.6.1 10.6.2
Cart ... 10-33 Removing and installing the concentrate rack... 10-33 Cart with four braked rollers ... 10-34 10.6.2.1 Removing and installing the swivel rollers... 10-34 10.6.2.2 Removing and installing the pedals with shaft ... 10-35
Fresenius Medical Care
5008
SM-EN
15A-2014
vii
10.6.3
10.6.2.3 Removing and installing the brake shaft ... 10-36 Cart with two braked rollers ... 10-37 10.6.3.1 Removing and installing the rear swivel rollers ... 10-37 10.6.3.2 Removing and installing the brake engagement ... 10-37 10.6.3.3 Adjusting the brake... 10-39
10.7 10.7.1
Rechargeable battery ... 10-40 Removing and installing the battery pack ... 10-40
10.8 10.8.1 10.8.2 10.8.3 10.8.4 10.8.5
Monitor... 10-41 Removing and installing the monitor and the monitor support arm ... 10-41 Adjusting monitor movements ... 10-43 Monitor transport protection... 10-46 Updating the monitor operating system M1 ... 10-46 Removing and installing the monitor front with touch / display unit and rear part... 10-46
10.9 10.9.1 10.9.2 10.9.3
Power supply unit and power cable... 10-49 Removing and installing the power cable ... 10-49 Removing and installing the power supply unit... 10-49 Removing and installing the power plug fuse (UK version only)... 10-51
10.10 Extracorporeal Blood Circuit Module (EBM)... 10-52 10.10.1 Removing and installing the EBM doors... 10-52 10.10.2 Opening and closing the EBM ... 10-52 10.10.3 Removing and installing the EBM... 10-53 10.10.4 Replacing the pneumatic tubings in the EBM ... 10-56 10.10.5 Removing and installing the arterial pressure measurement unit... 10-57 10.10.6 Removing and installing the venous and arterial occlusion clamp ... 10-58 10.10.7 Resetting the zero point of the pressure transducers (EBM)... 10-59 10.10.8 Verification / repair procedure in case of ingress of blood or fluid via the pressure line... 10-60 10.10.9 Checking the pneumatics of the arterial pressure measurement unit... 10-62 10.10.10 Checking the venous pressure transducer for leakage ... 10-63 10.10.11 Checking the Single-Needle pressure transducer with compliance chamber for leakage... 10-64 10.10.12 Removing and installing the grip handle of the occlusion clamps ... 10-65 10.10.13 Removing and installing the air bubble detector ABD ... 10-66 10.10.14 Removing and installing the heparin pump grip handle... 10-67 10.10.15 Removing and installing the heparin pump length sensor ... 10-68 10.10.16 Removing and installing the heparin pump... 10-69 10.10.17 Removing and installing the level detector ... 10-74 10.10.18 Removing and installing the online module ... 10-75 10.10.19 Removing and installing the blood temperature monitor (BTM) (option) ... 10-76 10.10.20 Removing and installing the blood volume monitor (BVM) (option)... 10-76 10.11 Hydraulics ... 10-79 10.11.1 Removing and installing the pressure reducing valve A04, water inlet... 10-79 10.11.2 Removing and installing the heat exchanger... 10-80 10.11.3 Removing and installing the float switch S01 of the water inlet chamber ... 10-82 10.11.4 Removing and installing the degassing orifice... 10-84 10.11.5 Removing and installing the heater rod ... 10-86 10.11.6 Removing and installing the concentrate pump... 10-87 10.11.7 Removing and installing the bicarbonate pump... 10-87 10.11.8 Removing and installing the UF pump... 10-88 10.11.9 Removing and installing the gear pump drive... 10-90 10.11.10 Removing and installing the balancing chamber ... 10-91 10.11.11 Removing and installing the blood leak detector ... 10-92 10.11.12 Removing and installing the flap lid ... 10-94 10.11.13 Removing and installing the bibag® connector... 10-95 10.11.14 Removing and installing the concentrate rinse chamber ... 10-96
viii
Fresenius Medical Care
5008
SM-EN
15A-2014
10.11.15 Removing and installing the bicarbonate rinse chamber... 10-97 10.11.16 Removing and installing the CDS block ... 10-98 10.11.16.1Vent valve of CDS block... 10-99 10.11.17 Temperature and conductivity sensors, calibration after replacement ... 10-100 10.11.18 Disinfectant valves (yellow labels) V20 and V34 ... 10-101 10.11.19 Deactivating the Flush function ... 10-103 10.11.20 Removing and installing the dosing chamber... 10-105 10.11.21 Removing and installing the float switch S02 of the mixing chamber ... 10-107 10.11.22 Removing the covers of PCBs LP 1123, LP 1124 and LP 1125 ... 10-109 10.11.23 Removing and installing the pressure pad ... 10-110 10.12
Checking the network interface ... 10-111
10.13 Printed circuit boards ... 10-113 10.13.1 PCB LP 1102 Controller board (C167) ... 10-113 10.13.2 PCB LP 1103 External interface unit ... 10-116 10.13.3 PCB LP 1104 Monitor power supply board ... 10-121 10.13.4 PCB LP 1105 Power supply CPU... 10-124 10.13.5 PCB LP 1106 Power supply distribution board... 10-126 10.13.6 PCB LP 1107-4 EBM I/O board... 10-128 10.13.7 PCB LP 1108-3 Hydraulics actuators ... 10-133 10.13.8 PCB LP 1109 Hydraulics sensors OS ... 10-136 10.13.9 PCB LP 1110 Hydraulics sensors SS... 10-139 10.13.10 PCB LP 1113 Hydraulics valve control board... 10-141 10.13.11 PCB LP 1123 Hydraulics distribution board, door left ... 10-142 10.13.12 PCB LP 1124 Hydraulics distribution board, front ... 10-144 10.13.13 PCB LP 1125 Hydraulics distribution board, door right ... 10-146 10.13.14 PCB LP 1126 Heparin pump control board ... 10-148 10.13.15 PCB LP 1129 Monitor distribution board ... 10-149 10.13.16 PCB LP 1131 Monitor operating mode indicator ... 10-150 10.13.17 PCB LP 1131-2 Monitor operating mode indicator with wireless module... 10-151 10.13.18 PCB LP 1132 Key LED board ... 10-152 10.13.19 PCB LP 1134 Monitor card reader ... 10-153 10.13.20 PCB LP 1139 Display failure sensor ... 10-154 10.13.21 PCB LP 1144 EBM door sensor ... 10-155 10.13.22 PCB LP 1148 Monitor distribution board ... 10-156 10.13.23 PCB LP 1202 Controller board (C167) ... 10-159 10.13.23.1Combination of PCB LP 1202 with PCBs LP 1107 / LP 1108 ... 10-161 10.13.24 PC board ... 10-162 10.14 Troubleshooting ... 10-164 10.14.1 Troubleshooting with dark display ... 10-164 10.14.2 Troubleshooting in case of unclear crashes and suspected CAN bus problems ... 10-167
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
Fresenius Medical Care
5008
SM-EN
15A-2014
ix
11.7
Hydraulics (block diagram / description) ... 11-12
11.8
Hydraulics (flow diagram, legend, description)... 11-14
12 Appendix
x
Fresenius Medical Care
5008
SM-EN
15A-2014
Chapter 1: Index
1
Index
A
B
– Checking 9-18
Accessories and test equipment 8-1
Balancing chamber, removing and installing 10-91
C
Accessories required – Decommissioning 3-32 – Decommissioning extension 3-40 – TSC / MA 6-2
Basic procedures 10-9
Addresses 2-4
Batteries – PC board 10-163 – PCB LP1105 10-125 – TSC / MA 6-23 – VenAcc (option) 4-30, 9-17
Adjusting monitor movements 10-43
Battery pack, removing and installing 10-40
Adjusting the brake (two braked rollers) 10-39
bibag® connector – switch position 10-142
Adjustment 9-1 Air bubble detector 4-22
bibag® connector, removing and installing 10-95
Air bubble detector ABD, removing and installing 10-66
Bicarbonate pump, removing and installing 10-87
Air bubble detector settings 5-7
Bicarbonate rinse chamber, removing and installing 10-97
Alarm output 4-16
Block diagrams – EBM 11-7 – Hydraulics 11-12 – Monitor 11-3 – Pneumatics 11-8 – Power supply unit 11-5
Alarm override 4-16 Alarm processing 5-28 Anticoagulation 5-17 Antifreeze 4-14 APPLICATIONS – PatientCard 5-47 – Sampling 5-48 – selecting / setting 5-47 – Training 5-48
Blood leak detector 4-18 Blood leak detector, removing and installing 10-92 Blood lines 5-16
AquaUNO / AquaC UNO H 4-15 Arterial occlusion clamp, removing and installing 10-58
Blood pump 4-21, 5-16
Arterial pressure measurement 4-21 Arterial pressure measurement unit, removing and installing 10-57 Atmospheric pressure 4-12 Audible alarm 4-23 Audio paused 4-16
Blood pressure monitor (BPM) (option), removing and installing 10-19 Blood temperature monitor (BTM) (option), removing and installing 10-76 Blood volume monitor (BVM) (option), removing and installing 10-76 BPM (option) 4-31, 5-42
Authorized persons 2-3
Brake engagement, removing and installing 10-37
Auto On 5-34 AutoFlow 4-20
Brake shaft, removing and installing 10-36 BTM (option) 4-31, 5-12, 5-43 BVM (option) 4-32, 5-12, 5-44
Fresenius Medical Care
5008
SM-EN
15A-2014
CALIBRATION 9-3 – Blood leak 9-10 – Calibrate touch screen 9-3 – Conductivity (CD7/CD9) 9-9 – Degassing (A01/P01) 9-4 – ECMP configuration 9-11 – Flow pump (A03) 9-7 – Loading pump (A02/P02) 9-5 – OCM 9-10 – Pressure transducer (S03/S07/S15/S16) 9-4 – Temperature (PT7/PT8/PT9) 9-8 – Volumes 9-10 Cart 10-33 Cart with four braked rollers 10-34 Cart with two braked rollers 10-37 CDS block, removing and installing 10-98 Central delivery system (option) 4-12 Checking the BVM (option) 9-18 Checking the pneumatics of the arterial pressure measurement unit 10-62 Checking the Single-Needle pressure transducer with compliance chamber for leakage (option) 10-64 Checking the venous pressure transducer for leakage 10-63 Circulation 4-17 Cleaning 5-34 Cleaning programs 4-17 Closing plugs 8-4 Color code of the heater rod connector 10-86 Component overview – EBM 10-3 – Hydraulics 10-4 – Monitor 10-2 Concentrate pump, removing and installing 10-87
1-1
Chapter 1: Index
Concentrate rack, removing and installing 10-33
Dialysis water inlet temperature 4-11
Concentrate rinse chamber, removing and installing 10-96
Dialysis water quality 4-11 Dialysis water supply line 4-11
Concentrate supply 4-11
DIASAFE®plus 4-27
Concentration of disinfectant 4-21
F
Dimensions of the hemodialysis system 4-1
Flap lid, removing and installing 10-94
Conductivity sensors – Calibration after replacement 10-100 Connecting the tubing to the adapter 10-12 Considerations for working on the hemodialysis system 2-3 Consumption data 4-13
D Deactivating Flush (option) 10-103 Decommissioning 9-20 – Accessories required 3-32 – Explanatory notes for completing the report 3-35 – Identification sheet 3-34 – Important information 3-32 – Report 3-33 Decommissioning extension – Accessories required 3-40 – Explanatory notes for completing the report 3-42 – Important information 3-40 – Report 3-41 Define cleaning parameters 5-8 Degassing orifice, removing and installing 10-84 Descriptions – EBM 11-8 – Hydraulics 11-13, 11-17 – Monitor 11-4 – Pneumatics 11-9 – Power supply unit 11-6 DIAGNOSTICS 9-12 – BPM (option) 9-17 – BTM (option) 9-19 – BVM (option) 9-18 – EBM 9-12 – Hydraulics 9-14 – Monitor 9-12 – Power supply unit 9-16 – Wireless (option) 9-16 Dialysate 5-19 Dialysis water inlet pressure 4-11 Dialysis water inlet rate 4-11
1-2
Disinfectant valves V20 and V34 (yellow labels) 10-101 Dosing chamber, removing and installing 10-105
E EBM – Block diagram 11-7 – Description 11-8 – Doors, removing and installing 10-52 – Opening and closing 10-52 – Removing and installing 10-53 – Zero point of the pressure transducers, resetting 10-59 EBM settings 5-5 EcoFlow 4-20 Electrical power supply 4-4 Electrical safety 4-3, 6-36 Electrical safety check 6-36 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 5-37
External connection options 4-15 Extracorporeal Blood Circuit Module EBM 10-52
Float switch S01 of the water inlet chamber, removing and installing 10-82 Float switch S02 of the mixing chamber, removing and installing 10-107 Flow diagram 9-2, 11-14 – Description 11-17 – Legend 11-15 Flush (option) 4-18, 10-103 Functional description 11-1 Fuses – PCB LP1103 10-118 – PCB LP1104 10-122, 10-166 – PCB LP1106 10-4, 10-127 – PCB LP1107-4 10-131 – PCB LP1113 10-141 – Power plug, UK version 10-51 – Power switch 4-4 – Rechargeable battery 4-4, 10-8 – TSC / MA 6-7, 6-36
G Gear pump drive, removing and installing 10-90 Grip handle of the occlusion clamps, removing and installing 10-65
H
Energy data 4-13
HD-PAED (option) 5-45
Error messages 7-1 ESD precautions 2-3 Explanatory notes – Decommissioning extension report 3-42 – Decommissioning report 3-35 – Identification sheet 3-35 – Initial start-up report 3-6 – Recommissioning report after decommissioning 3-46 – TSC / MA report 6-7 – TSC report 6-7 Extended safety 5-38
Heat exchanger, removing and installing 10-80 Heater rod, removing and installing 10-86 Heparin pump 4-22 Heparin pump grip handle, removing and installing 10-67 Heparin pump length sensor, removing and installing 10-68 Heparin pump, removing and installing 10-69
Fresenius Medical Care
5008
SM-EN
15A-2014
Chapter 1: Index
Home dialysis 3-2 Home healthcare environment 3-2 Housing 10-13 Housing main part, removing and installing 10-28 How to use the Service Manual 2-1 Hydraulics 10-79 – Block diagram 11-12 – Description 11-13, 11-17 – Flow diagram 11-14 Hydraulics front door, left, removing and installing 10-23 Hydraulics front door, right, removing and installing 10-21 Hydraulics settings 5-4
I Identification label 4-2 Illustrations 2-2 Important information 2-1 – Decommissioning 3-32 – Decommissioning extension 3-40 – Initial start-up 3-1 – Operation in a domestic environment 3-2 – Recommissioning after decommissioning 3-44 – Removal from service 3-50 – 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 10-60 Initial start-up – Explanatory notes 3-6 – Important information 3-1 – Operation in a domestic environment 3-2 – Report 3-3 Installation altitude 4-12
PCB LP1108-3 10-134 PCB LP1109 10-137 PCB LP1123 10-142 PCB LP1129 10-149 PCB LP1148 10-156
L LAN 4-15 LEDs – PCB LP1102 10-114 – PCB LP1104 10-122, 10-166 – PCB LP1105 10-125 – PCB LP1107-4 10-131 – PCB LP1108-3 10-135 – PCB LP1124 10-144 – PCB LP1131 10-150 – PCB LP1131-2 (wireless module) 10-151 – PCB LP1132 10-152 – PCB LP1202 10-160 Level detector, removing and installing 10-74
Network interface, checking 10-111
O OCM 4-27, 5-41 Online module, removing and installing 10-75 ONLINEplus™ 4-27, 5-38 Opening the hydraulics front doors 10-21 Operating conditions 4-11 Operating programs 4-16 Operating temperature range 4-12 Operation in the home healthcare environment - Important information 3-2 Optical detector 4-22
M Maintenance procedures (MAs) 6-1 Manufacturer 2-4 Materials 4-24, 4-26 Materials used 4-24 Media supply rail – opening and closing the cover 10-19 Miscellaneous 5-10, 5-42 MODULE 9-19 – Novram 9-19 Monitor 10-41 – Block diagram 11-3 – Description 11-4 Monitor compatibility matrix 10-157 Monitor front with touch / display unit and rear part, removing and installing 10-46
Monitor with support arm, removing and installing 10-41
Jumpers – PCB LP1102 10-114 – PCB LP1103 10-118 – PCB LP1104 10-122
Network 4-29, 5-11
Novram 9-19
Monitor transport protection 10-46
J
N
Note symbol, significance 2-2
Monitor operating system, updating 10-46
IV pole 4-12
Fresenius Medical Care
– – – – –
Override conditions 4-16
P PC board – Battery 10-163 – Calibration after replacement 10-163 – Installation location 10-163 – Required tests 10-163 PCB covers 10-109 PCB LP1102 – Calibration after replacement 10-115 – Connectors 10-114 – Installation location 10-114 – Jumpers 10-114 – LEDs 10-114 – Required tests 10-115 PCB LP1103 – Calibration after replacement 10-120 – Fuses 10-118 – Installation location 10-118 – Jumpers 10-118 – Potentiometers 10-120 – Required tests 10-120 PCB LP1104 – Calibration after replacement
5008
SM-EN
15A-2014
1-3
Chapter 1: Index
– – – – – –
10-123 Fuses 10-122 Installation location 10-121 Jumpers 10-122 LEDs 10-122 Required tests 10-123 Solder bridges 10-122
PCB LP1105 – Battery 10-125 – Calibration after replacement 10-125 – Installation location 10-125 – LEDs 10-125 – Required tests 10-125 PCB LP1106 – Calibration after replacement 10-127 – Fuses 10-127 – Installation location 10-126 – Required tests 10-127 PCB LP1107-4 – Calibration after replacement 10-131 – Fuses 10-131 – Installation location 10-130 – LEDs 10-131 – Required tests 10-131 PCB LP1108-3 – Calibration after replacement 10-135 – Installation location 10-134 – Jumpers 10-134 – LEDs 10-135 – Required tests 10-135 PCB LP1109 – Calibration after replacement 10-138 – Installation location 10-137 – Jumpers 10-137 – Required tests 10-138 – Solder bridges 10-137 PCB LP1110 – Calibration after replacement 10-140 – Installation location 10-140 – Required tests 10-140 PCB LP1113 – Calibration after replacement 10-141 – Fuses 10-141 – Installation location 10-141 – Required tests 10-141 PCB LP1123 – Calibration after replacement
1-4
10-142 Installation location 10-142 Jumpers 10-142 Required tests 10-142 Solder bridges 10-142
PCB LP1139 – Calibration after replacement 10-154 – Installation location 10-154 – Required tests 10-154
PCB LP1124 – Calibration after replacement 10-144 – Installation location 10-144 – Jumpers 10-144 – LEDs 10-144 – Required tests 10-145 – Solder bridges 10-144
PCB LP1144 – Calibration after replacement 10-155 – Installation location 10-155 – Required tests 10-155
– – – –
PCB LP1125 – Calibration after replacement 10-146 – Installation location 10-146 – Jumpers 10-146 – Required tests 10-146 – Solder bridges 10-146 PCB LP1126 – Calibration after replacement 10-148 – Installation location 10-148 – Required tests 10-148 PCB LP1129 – Calibration after replacement 10-149 – Installation location 10-149 – Jumpers 10-149 – Required tests 10-149 PCB LP1131 – Calibration after replacement 10-150 – Installation location 10-150 – LEDs 10-150 – Required tests 10-150 PCB LP1131-2 – Calibration after replacement 10-151 – Installation location 10-151 – LEDs 10-151 – Required tests 10-151 PCB LP1132 – Calibration after replacement 10-152 – Installation location 10-152 – LEDs 10-152 – Required tests 10-152 PCB LP1134 – Calibration after replacement 10-153 – Installation location 10-153 – Required tests 10-153
PCB LP1148 – Calibration after replacement 10-158 – Installation location 10-156 – Jumpers 10-156 – Monitor compatibility matrix 10-157 – Required tests 10-158 – Solder bridges 10-156 PCB LP1202 – Calibration after replacement 10-160 – Installation location 10-159 – LEDs 10-160 – Required tests 10-160 PCBs, overview 11-2 Pedals with shaft, removing and installing 10-35 Pneumatic tubings in the EBM, replacing 10-56 Pneumatics – Block diagram 11-8 – Control states 11-10 – Description 11-9 Power cable, removing and installing 10-49 Power plug fuse (UK version only), removing and installing 10-51 Power supply unit – Block diagram 11-5 – Description 11-6 Power supply unit, removing and installing 10-49 Precautions 2-3 Preparation 4-16 Pressure holding test 4-18 Pressure pad, removing and installing 10-110 Pressure reducing valve A04, water inlet, removing and installing 10-79 Priming and rinsing 4-16
Fresenius Medical Care
5008
SM-EN
15A-2014
Chapter 1: Index
Printed circuit boards – Combination, PCB LP 1202 with PCBs LP 1107 / LP 1108 10-161 – PC board 10-162 – PCB LP1102 10-113 – PCB LP1103 10-116 – PCB LP1104 10-121 – PCB LP1105 10-124 – PCB LP1106 10-126 – PCB LP1107-4 with attached PCB LP1158 10-128 – PCB LP1107-4 with integrated PCB LP1158 10-129 – PCB LP1108-3 10-133 – PCB LP1109 10-136 – PCB LP1110 10-139 – PCB LP1113 10-141 – PCB LP1123 10-142 – PCB LP1124 10-144 – PCB LP1125 10-146 – PCB LP1126 10-148 – PCB LP1129 10-149 – PCB LP1131 10-150 – PCB LP1131-2 (wireless module) 10-151 – PCB LP1132 10-152 – PCB LP1134 10-153 – PCB LP1139 10-154 – PCB LP1144 10-155 – PCB LP1148 10-156 – PCB LP1202 10-159 – PCBs, overview 11-2
Q Quick Guide - Service Software 5-50
R Rear swivel rollers, removing and installing 10-37 Rechargeable battery – Decommissioning 3-34 – Fuse 4-4 – Maintenance 4-14 – Removing and installing 10-40 – Specifications 4-4 – TSC / MA 6-23 – Voltage 4-4, 9-16 Recommissioning after decommissioning – Explanatory notes for completing the report 3-46
Fresenius Medical Care
5008
– Important information 3-44 – Report 3-45 Reinfusion 4-17 Relative humidity 4-12 Relocating a device used in a home healthcare environment 3-2 Remote maintenance 9-23 Removal from service – Important information 3-50 Removing and installing – Air bubble detector ABD 10-66 – Arterial occlusion clamp 10-58 – Arterial pressure measurement unit 10-57 – Balancing chamber 10-91 – Battery pack 10-40 – bibag® connector 10-95 – Bicarbonate pump 10-87 – Bicarbonate rinse chamber 10-97 – Blood leak detector 10-92 – Blood pressure monitor (BPM) (option) 10-19 – Blood temperature monitor (BTM) (option) 10-76 – Blood volume monitor (BVM) (option) 10-76 – Brake engagement (two braked rollers) 10-37 – Brake shaft (four braked rollers) 10-36 – CDS block 10-98 – Concentrate pump 10-87 – Concentrate rack 10-33 – Concentrate rinse chamber 10-96 – Conductivity sensors 10-100 – Degassing orifice 10-84 – Dialyzer coupling 10-17 – Dialyzer holder 10-18 – Disinfectant valve V20 (yellow label) 10-101 – Disinfectant valve V34 (yellow label) 10-101 – Dosing chamber 10-105 – EBM 10-53 – EBM doors 10-52 – Flap lid 10-94 – Float switch S01 10-82 – Float switch S02 10-107 – Gear pump drive 10-90 – Grip handle of the occlusion clamps 10-65 – Heat exchanger 10-80 – Heater rod 10-86
SM-EN
15A-2014
– Heparin pump 10-69 – Heparin pump grip handle 10-67 – Heparin pump length sensor 10-68 – Housing, main part 10-28 – Hydraulics front door, left 10-23 – Hydraulics front door, right 10-21 – IV pole 10-13 – Level detector 10-74 – Monitor front with touch / display unit 10-46 – Monitor with support arm 10-41 – Online module 10-75 – PCB covers 10-109 – Pedals with shaft (four braked rollers) 10-35 – Pneumatic tubings in the EBM 10-56 – Power cable 10-49 – Power plug fuse (UK version only) 10-51 – Power supply unit 10-49 – Pressure pad 10-110 – Pressure reducing valve A04 10-79 – Rear swivel rollers (two braked rollers) 10-37 – Service door, left 10-27 – Service door, right 10-24 – Shunt interlock 10-14 – Shunt interlock mark 10-16 – Shunt interlock microswitch 10-15 – Swivel rollers (four braked rollers) 10-34 – Temperature sensors 10-100 – UF pump 10-88 – Venous occlusion clamp 10-58 Removing and installing the dialyzer coupling 10-17 Removing and installing the dialyzer holder 10-18 Removing and installing the IV pole 10-13 Removing and installing the microswitch in the installed shunt interlock 10-15 Removing and installing the shunt interlock 10-14 Removing and installing the shunt interlock mark 10-16
1-5
Chapter 1: Index
Repair procedure in case of ingress of blood or fluid via the pressure line 10-60
Single-Needle Click-Clack 4-23
Treatment 4-16
SNAPLOC attachment 10-9
Troubleshooting in case of unclear crashes and suspected CAN bus problems 10-167
Software options 5-13
Reports – Decommissioning 3-33 – Decommissioning extension 3-41 – Identification sheet (decommissioning) 3-34 – Initial start-up 3-3 – Recommissioning after decommissioning 3-45 – TSC 6-44 – TSC / MA 6-3
Solder bridges – PCB LP1104 10-122 – PCB LP1109 10-137 – PCB LP1123 10-142 – PCB LP1124 10-144 – PCB LP1125 10-146 – PCB LP1148 10-156
Rinse / reinfusion volume 5-16
Stability 4-12
Rinse and disinfection flow 4-21
Stationary equipment 3-2
S
Stopping a disinfection program 2-3
Self-cutting screws 10-10
Storage conditions 4-14
SERVICE – CALIBRATION 9-3 – DIAGNOSTICS 9-12 – Flow diagram 9-2 – MODULE 9-19 – Remote maintenance 9-23 – selecting 9-1 – UPDATE 9-20 – VARIOUS 9-19 Service / diagnostics 4-15 Service door, left, removing and installing 10-27 Service door, right, removing and installing 10-24 Service setup 5-3 Service Software - Quick Guide 5-50 Setting the max. water inflow 9-2 SETUP (Service setup) – Air bubble detector settings 5-7 – BTM (option) 5-12 – BVM (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) 5-13 Single-Needle (option) 4-30, 5-41 Single-Needle chamber (option) 4-30
1-6
Software update 9-20, 10-46
Spare parts 2-3 Specifications 4-1
Styles used in the document 2-1 Swivel rollers, removing and installing 10-34 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
Troubleshooting with dark display 10-164 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 10-88 UFC measurement 4-18 Ultrafiltration 4-18, 5-28 UPDATE 9-20 Updating monitor operating system M1 10-46 Updating the software version in a replaced module 9-20
T T1 test 4-16 Technical safety checks (TSCs) 6-1 Temperature at water drain 4-11 Temperature sensors – Calibration after replacement 10-100 Test equipment and accessories 8-1 Tilting the hemodialysis system 10-9 Tilting the hemodialysis system back 10-9 Tilting tool 8-6 Tip symbol, significance 2-2 Transmembrane pressure 4-18 Transporting a device used in a home healthcare environment 3-2
Updating the software version of the hemodialysis system with a new CF card 9-21 Updating the software version of the hemodialysis system with the 5008 PC Service Software 9-22 User interface 5-31 USER SETUP – Alarm processing 5-28 – Anticoagulation 5-17 – Auto On 5-34 – Blood lines 5-16 – Blood pump 5-16 – BPM (option) 5-42 – BTM (option) 5-43 – BVM (option) 5-44 – Cleaning 5-34 – Dialysate 5-19 – Emergency 5-37 – Extended safety 5-38 – HD-PAED (option) 5-45
Fresenius Medical Care
5008
SM-EN
15A-2014
Chapter 1: Index
– – – – – – – – –
Miscellaneous 5-42 OCM 5-41 ONLINE 5-38 Rinse / reinfusion volume 5-16 selecting / setting 5-15 Single-Needle (option) 5-41 Ultrafiltration 5-28 User interface 5-31 VenAcc (option) 5-46
V VenAcc (option) 5-46 Venous occlusion clamp, removing and installing 10-58 Venous pressure measurement 4-22 Vent valve of CDS block 10-99 Verification procedure in case of ingress of blood or fluid via the pressure line 10-60
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) 5-13 Working on the hemodialysis system 2-3 Wrench torques 10-13
Z Zero point of the pressure transducers (EBM), resetting 10-59
Fresenius Medical Care
5008
SM-EN
15A-2014
1-7
Chapter 1: Index
1-8
Fresenius Medical Care
5008
SM-EN
15A-2014
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. ...
Fresenius Medical Care
5008
SM-EN
15A-2014
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
Fresenius Medical Care
5008
SM-EN
15A-2014
Chapter 2: Important information
2.5
Considerations 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 safety measures.
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 must be performed (see Electrical safety check on page 6-36). 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.
5008
SM-EN
15A-2014
2-3