5008 Hemodialysis System
Operating Instructions
Software version: 3.52
Edition: 5/09.06
Part no.: M38 816 1
0123
Fresenius Medical Care
Table of Contents |
Page |
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1Index
2Important Information
|
2.1 |
Important Information on the Operating Instructions............................................................ |
2-1 |
|
2.2 |
Important Information on the System...................................................................................... |
2-3 |
|
2.3 |
Addresses .................................................................................................................................. |
2-8 |
3 |
Design |
|
|
|
3.1 |
Front View .................................................................................................................................. |
3-1 |
|
3.2 |
Rear View ................................................................................................................................... |
3-2 |
|
3.3 |
Lateral View, Left Side .............................................................................................................. |
3-3 |
|
3.4 |
Lateral View, Right Side............................................................................................................ |
3-4 |
|
3.5 |
Monitor Front ............................................................................................................................. |
3-6 |
|
3.6 |
Monitor Rear .............................................................................................................................. |
3-7 |
|
3.7 |
Extracorporeal Blood Module .................................................................................................. |
3-8 |
|
3.8 |
Extracorporeal Blood Module with Additional Functions ................................................... |
3-12 |
|
3.9 |
Hydraulics ................................................................................................................................ |
3-13 |
|
3.10 |
Hydraulics Connectors ........................................................................................................... |
3-14 |
|
3.11 |
External Connection Options/Connection to Power Supply ............................................... |
3-15 |
4 |
Graphical User Interface |
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|
|
4.1 |
After Turning Power on to the System .................................................................................... |
4-1 |
|
4.2 |
Overview (Screen) ..................................................................................................................... |
4-2 |
|
4.3 |
General Operation Philosophy................................................................................................. |
4-3 |
|
4.4 |
Examples for Data Entry (Treatment Data) ............................................................................. |
4-7 |
|
4.5 |
Screen Saver.............................................................................................................................. |
4-9 |
5 |
Preparation |
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|
|
5.1 |
Preparation using ONLINEplus™ ........................................................................................... |
5-1 |
|
5.2 |
Preparation with Rinse Solution Bag .................................................................................... |
5-17 |
|
5.3 |
Single-Needle (Option) Preparation Using ONLINEplus™ ................................................. |
5-31 |
|
5.4 |
Single-Needle (Option) Preparation with Rinse Solution Bag............................................. |
5-47 |
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Table of Contents Page
6 |
Treatment |
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|
|
6.1 |
TreatmentusingONLINEplus™ ................................................................................................. |
6-1 |
|
6.2 |
Treatment (Prepared with Rinse Solution Bag) ...................................................................... |
6-5 |
|
6.3 |
Single-Needle (Option) Treatment Using ONLINEplus™ ....................................................... |
6-9 |
|
6.4 |
Single-Needle (Option) Treatment (Prepared with Rinse Solution Bag) ............................ |
6-17 |
7 |
Reinfusion |
|
|
|
7.1 |
Reinfusion using ONLINEplus™ .............................................................................................. |
7-1 |
|
7.2 |
Reinfusion with Rinse Solution Bag ........................................................................................ |
7-5 |
|
7.3 |
Single-Needle (Option) Reinfusion Using ONLINEplus™...................................................... |
7-9 |
|
7.4 |
Single-Needle (Option) Reinfusion with Rinse Solution Bag ................................................ |
7-9 |
8 |
Cleaning |
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|
|
8.1 |
Basic Requirements .................................................................................................................. |
8-1 |
|
8.2 |
Connecting the Disinfectant Container ................................................................................... |
8-2 |
|
8.3 |
Starting a Cleaning / Disinfection Program............................................................................. |
8-3 |
|
8.4 |
Aborting a Cleaning / Disinfection Program ........................................................................... |
8-4 |
|
8.5 |
Cleaning / Disinfection Program Complete............................................................................. |
8-4 |
|
8.6 |
Checking for Residual Disinfectant ......................................................................................... |
8-5 |
|
8.7 |
Surface Cleaning / Disinfection................................................................................................ |
8-5 |
|
8.8 |
Turning the Hemodialysis System Off..................................................................................... |
8-6 |
9 |
Alarm Processing |
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|
|
9.1 |
Messages (Information/Warning/Alarm).................................................................................. |
9-1 |
|
9.2 |
Air Detected Below the Venous Bubble Catcher .................................................................... |
9-2 |
|
9.3 |
Micro Bubbles Detected Below the Venous Bubble Catcher ................................................ |
9-7 |
|
9.4 |
Management of Alarm Limits.................................................................................................. |
9-14 |
|
9.5 |
Blood Leak ............................................................................................................................... |
9-14 |
|
9.6 |
Conductivity ............................................................................................................................. |
9-15 |
|
9.7 |
Manually Opening the Arterial Pressure Measurement Unit ............................................... |
9-15 |
|
9.8 |
Power Failure (Outage) ........................................................................................................... |
9-15 |
|
9.9 |
Screen Failure.......................................................................................................................... |
9-17 |
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Table of Contents Page
10 Other Functions |
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|
10.1 |
SYSTEM SCREEN Settings..................................................................................................... |
10-1 |
10.2 |
Operator Setup ........................................................................................................................ |
10-2 |
10.3 |
Emergency Button................................................................................................................. |
10-26 |
10.4 |
Emptying / Changing the bibag®.......................................................................................... |
10-26 |
10.5 |
Changing the DIASAFE®plus ............................................................................................... |
10-27 |
10.6 |
Cleaning the Dialysate Particle Filter .................................................................................. |
10-28 |
10.7 |
Collecting a Sample .............................................................................................................. |
10-28 |
10.8 |
Removing Lines During Preparation ................................................................................... |
10-28 |
10.9 |
Removing Lines During Treatment...................................................................................... |
10-29 |
10.10 |
Circulation.............................................................................................................................. |
10-30 |
10.11 |
Setting the Level in the Venous Bubble Catcher................................................................ |
10-31 |
10.12 |
Single-Needle Click-Clack .................................................................................................... |
10-32 |
11 System Description
11.1 |
Specifications .......................................................................................................................... |
11-1 |
11.2 |
Storage ................................................................................................................................... |
11-16 |
11.3 |
Transportation ....................................................................................................................... |
11-16 |
11.4 |
Environmental Compatibility and Recycling ...................................................................... |
11-17 |
11.5 |
System Description ............................................................................................................... |
11-22 |
11.6 |
Blood Lines (Description)..................................................................................................... |
11-34 |
11.7 |
Initial Start-Up ........................................................................................................................ |
11-42 |
11.8 |
Technical Safety Checks and Technical Measurement Checks ....................................... |
11-47 |
11.9 |
Definitions and Terms........................................................................................................... |
11-52 |
11.10 |
Abbreviations......................................................................................................................... |
11-53 |
11.11 |
Symbols.................................................................................................................................. |
11-54 |
11.12 |
Consumables Symbols ......................................................................................................... |
11-55 |
12 Consumables
12.1 |
To be Observed in Chapter Consumables ............................................................................ |
12-1 |
12.2 |
Dialyzers................................................................................................................................... |
12-1 |
12.3 |
Blood Lines .............................................................................................................................. |
12-1 |
12.4 |
Disposable Syringes ............................................................................................................... |
12-2 |
12.5 |
Hemodialysis Concentrates ................................................................................................... |
12-2 |
12.6 |
Dialysate Filter DIASAFE®plus............................................................................................... |
12-2 |
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Table of Contents |
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12.7 |
Surface Disinfection / Surface Cleaning |
................................................................................ 12-3 |
12.8 |
Disinfectants for the Hydraulics............................................................................................. |
12-3 |
12.9 |
Disinfectant Indicators ............................................................................................................ |
12-4 |
13 |
Certificates |
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|
|
13.1 |
EC Certificate ........................................................................................................................... |
13-1 |
14 |
Appendix |
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|
14.1 |
Bibliography............................................................................................................................. |
14-1 |
15 |
Option OCM (Online Clearance Monitoring) |
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|
|
15.1 |
To Be Observed Before Using the OCM ................................................................................ |
15-1 |
|
15.2 |
Menu Overview ........................................................................................................................ |
15-2 |
|
15.3 |
Checking/Setting the OCM Parameters ................................................................................. |
15-3 |
|
15.4 |
Stability Criteria ....................................................................................................................... |
15-4 |
|
15.5 |
Starting the OCM ..................................................................................................................... |
15-4 |
|
15.6 |
Aborting the OCM .................................................................................................................... |
15-4 |
|
15.7 |
Alarm Processing .................................................................................................................... |
15-5 |
16 |
ONLINEplus™ |
|
|
|
16.1 |
Menu Overview ........................................................................................................................ |
16-2 |
|
16.2 |
Preparation/Treatment/Reinfusion......................................................................................... |
16-3 |
17 |
Option SN (Single-Needle) |
|
|
|
17.1 |
Menu Overview ........................................................................................................................ |
17-2 |
|
17.2 |
Preparation/Treatment/Reinfusion......................................................................................... |
17-3 |
18 |
Option BPM (Blood Pressure Monitoring) |
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|
|
18.1 |
To Be Observed Before Using the BPM Option.................................................................... |
18-1 |
|
18.2 |
Blood Pressure Cuffs / Pressure Tubing............................................................................... |
18-1 |
|
18.3 |
Menu Overview ........................................................................................................................ |
18-2 |
|
18.4 |
Applying the Blood Pressure Cuff ......................................................................................... |
18-3 |
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Fresenius Medical Care 5008 OP 5/09.06 |
Table of Contents |
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18.5 |
Checking/Setting the Inflation Pressure/Alarm Limits |
......................................................... 18-3 |
18.6 |
Starting the Blood Pressure Measurement........................................................................... |
18-4 |
18.7 |
Blood Pressure Measurement Completed ............................................................................ |
18-4 |
18.8 |
Aborting the Blood Pressure Measurement ......................................................................... |
18-5 |
18.9 |
Displaying Graphics and Blood Pressure History ............................................................... |
18-5 |
19Option CBPM
20Option BTM (Blood Temperature Monitor)
20.1 |
To Be Observed Before Using the BTM Option.................................................................... |
20-1 |
20.2 |
Menu Overview ........................................................................................................................ |
20-2 |
20.3 |
Preparation............................................................................................................................... |
20-3 |
20.4 |
Recirculation............................................................................................................................ |
20-3 |
20.5 |
Temperature Control ............................................................................................................... |
20-4 |
20.6 |
Displaying Graphics and BTM Events................................................................................... |
20-4 |
21 Option BVM (Blood Volume Monitor)
|
21.1 |
To Be Observed Before Using the BVM Option.................................................................... |
21-1 |
|
21.2 |
Menu Overview ........................................................................................................................ |
21-2 |
|
21.3 |
Preparation............................................................................................................................... |
21-4 |
|
21.4 |
Calibration................................................................................................................................ |
21-4 |
|
21.5 |
Measuring the RBV (Relative Blood Volume), Hemoglobin and Hematocrit ..................... |
21-4 |
|
21.6 |
Displaying Graphics................................................................................................................ |
21-5 |
|
21.7 |
Alarm Processing .................................................................................................................... |
21-5 |
22 |
Network |
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|
22.1 |
To Be Observed Before Using the Network .......................................................................... |
22-1 |
|
22.2 |
DataXchange Panel ................................................................................................................. |
22-1 |
23 |
Options BLK, WET |
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23.1 |
To be Observed Before Using the BLK, WET Options......................................................... |
23-1 |
|
23.2 |
BLK ........................................................................................................................................... |
23-1 |
|
23.3 |
WET........................................................................................................................................... |
23-2 |
Fresenius Medical Care 5008 OP 5/09.06 |
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Table of Contents Page
24 Option smartbag
24.1 |
To Be Observed Before Using the smartbag Option............................................................ |
24-1 |
24.2 |
Connecting the smartbag ....................................................................................................... |
24-1 |
24.3 |
Removing the smartbag.......................................................................................................... |
24-2 |
viii |
Fresenius Medical Care 5008 OP 5/09.06 |
Chapter 1: Index
1 Index
How to use the index: Index entry 1-3, for example, refers to chapter 1, page 3
A
Abbreviations 11-53
ABD handling (air removal) 9-3
Acetate dialysis 5-4, 5-20, 5-34, 5-50
Additional optional equipment 2-6 Addresses 2-8
Air bubble detector 3-11, 11-11 Air removal 9-3
Alarm 9-1
Alarm limits, management 9-14 Alarm output (staff call) 3-15 Alarm override 11-7
Alarm processing 9-1, 10-14 Anticoagulation 10-3 AquaUNO 2-6, 3-15, 11-6
Arterial blood line 11-34, 11-36, 11-38, 11-40
Arterial blood line (Single-Needle part) 11-39, 11-41
Arterial injection site/collection site 11-34, 11-36, 11-38, 11-40
Arterial line, removing 10-29
Arterial measuring head (BTM) 3-12
Arterial occlusion clamp 3-8
Arterial patient connection 11-34, 11-36, 11-38, 11-40
Arterial pressure 4-3
Arterial pressure dome 5-8, 5-24, 5-38, 5-54, 11-34, 11-36, 11-38, 11-40
Arterial pressure measurement unit 3-8, 5-6, 5-8, 5-22, 5-24, 5-36, 5-38, 5-52, 5-54, 9-15, 11-22
Arterial pressure measurement unit, opening manually 9-15
Audible alarm 11-12
Audible alarm suppression 11-6 Auto On 10-18
AutoFlow 11-9
Auto-Single-Needle 11-13
Auto-sub 10-21
B
Barrel holder with syringe detector 3-10
Battery 11-16, 11-44
bibag® 5-20, 5-34, 5-50, 7-3, 7-6, 11-27
bibag® port 3-13
bibag®, connecting 5-4, 5-20, 5-34, 5-50
bibag®, emptying/changing 10-26 Bibliography 14-1
Bicarbonate dialysis 5-3, 5-19, 5-33, 5-49
Bicarbonate flap 3-13
Bicarbonate suction tube (blue) 3-13
BLK 23-1
Blood alarms 11-23, 11-52 Blood flow 4-3
Blood leak detector 11-8 Blood lines 12-1
Blood lines (description) 11-34
Blood lines with ONLINEplus™ 11-34
Blood lines with ONLINEplus™ Single-Needle 11-38
Blood lines with rinse solution bag 11-36
Blood Lines with Single Needle with rinse solution bags 11-40
Blood lines, removing 7-3, 7-7 Blood pressure 4-3, 11-13 Blood pressure cuff 3-12 Blood pressure cuffs 18-1
Blood pressure measurement 18-1
Blood pump 3-8, 3-10, 10-2 Body temperature control 11-14
BPM 3-12, 10-24, 11-30, 18-1 BPM pressure port 3-12 Bracket (heparin pump) 3-10 Brake 3-3, 3-4
Brief description 2-3
BTM 3-12, 10-25, 11-25, 11-31, 20-1
BTM (arterial measuring head) 3-12
BTM (venous measuring head) 3-12
Bubble catcher 11-52
BVM 3-12, 10-24, 11-25, 11-32, 21-1
BVM measuring head 3-12
C
Card receptacle 3-7
Central delivery system (CDS) 5-4, 5-20, 5-34, 5-50
Certificates 13-1
Circulation 10-30
Clamping lever (heparin pump) 3-10
Cleaning (basic requirements) 8-1 Cleaning program 8-3, 8-4 Cleaning programs 11-8 Concentrate flap 3-13
Concentrate rack 3-3, 3-4, 5-3, 5-19, 5-33, 5-49
Concentrate suction tube (red) 3-13
Concentrate supply, selecting 5-3, 5-19, 5-33, 5-49
Concentrates 5-3, 5-19, 5-33, 5-49, 11-9
Conductivity 11-52 Conductivity alarm 9-15
Connection, venous pressure line 11-34, 11-36, 11-38, 11-40
Connector for BIC, blue 3-14 Connector for CDS 1, red 3-14
Fresenius Medical Care 5008 OP 5/09.06 |
1-1 |
Chapter 1: Index
Connector for CDS 2, red 3-14
Connector postdilution 11-35, 11-39
Connector pre/postdilution (SafeLine™) 11-35, 11-39
Connector predilution 11-35, 11-39
Connector, SN pressure line 11-39, 11-41
Consumables 12-1
Contraindications 2-4 Course of the treatment 4-5 Cuff holder 3-12
D
Data entry, examples (treatment data) 4-7
Decalcification 12-3 Define options 10-15
Definitions and terms 11-52 Degreasing 12-4
Design 3-1
Dialysate couplings 3-5 Dialysate flow 11-9
Dialysate flow status indicator 4-2
Dialysate lines 3-4, 5-11, 5-26, 5-41, 5-56
Dialysate menu 5-12, 5-14, 5-27, 5-29, 5-42, 5-44, 5-57, 5-59
Dialysate parameters 5-12, 5-27, 5-42, 5-57, 6-3, 6-6, 6-13, 6-20
Dialysate particle filter, cleaning 10-28
Dialysate return line 3-4 Dialysate supply line 3-4 Dialysate temperature 11-9
Dialyzer 11-34, 11-36, 11-38, 11-40
Dialyzer connector (arterial blood line) 11-34, 11-36, 11-38, 11-40
Dialyzer connector (venous blood line) 11-34, 11-36, 11-38, 11-40
Dialyzer holder 3-4, 3-5 Dialyzer, emptying 7-2, 7-6 Dialyzers 12-1 DIASAFE®plus 11-12, 12-2
DIASAFE®plus, changing 10-27
Dimensions 11-1 Disclaimer of liability 2-5
Disinfectant connector, black 3-14
Disinfectant connector, yellow 3-14
Disinfectant container, connecting 8-2
Disinfectant indicators 12-4 Disinfectants 12-3 Disinfection 8-1
Disinfection program 8-3, 8-4 Display failure sensor 3-6
Double-Needle 5-1, 5-17, 5-31, 5-47, 6-1, 6-5, 7-1, 7-5
Duties of the responsible organization 2-4
E
EBM 11-53
EcoFlow 5-12, 5-27, 5-42, 5-57, 11-10
Electrical safety 11-2 Electrical supply 11-2
Electromagnetic compatibility (EMC) 11-3, 11-53
EMC 11-3, 11-53
Emergency 10-19
Emergency button 4-3, 10-19, 10-26
Emergency operation 9-16, 9-17 Environmental compatibility 11-17
External connection options 3-2, 3-15, 11-6
Extracorporeal blood module (EBM) 3-1, 3-8, 3-12, 5-8, 5-11, 5-24, 5-26, 5-38, 5-41, 5-54, 5-56
F
Fan filter (service door) 3-2 Fields of application 2-4 Filter 1 - DIASAFE®plus 3-4 Filter 2 - ONLINEplus™ 3-4 Filter chamber 3-4
Fixation for the plunger (heparin pump) 3-10
Flow alarm 11-11 Flow diagram 11-26
Flush 11-8
Flush drain 3-14
Front view 3-1
Fuses 11-2
G
General operation philosophy 4-3 Graphical user interface 4-1
Grip handle (heparin pump) 3-10 Groove 3-8
Guarantee 2-5 Guarantee / warranty 2-5
H
Handle 9-16, 9-17
Handle for an emergency operation 3-10
Header bar 4-4
Hemodialysis concentrates 12-2
Hemodialysis system, turning off 8-6
Hemodialysis system, turning on 5-1, 5-17, 5-31, 5-47
Heparin (menu) 5-15, 5-30, 5-45, 5-60
Heparin line 11-35, 11-36, 11-39, 11-41
Heparin menu 4-3
Heparin pump 3-8, 3-10, 11-12, 11-22
Heparin pump parameters 5-15, 5-30, 5-45, 5-60, 6-4, 6-7, 6-15, 6-21
Heparin status indicator 4-3
Heparin syringe 5-9, 5-25, 5-39, 5-55, 11-35, 11-36, 11-39, 11-41, 12-2
Holder for disinfectant container 3-14
Holder for SN chamber 3-12 Hydraulics 3-1, 3-2, 3-13, 3-14 Hydraulics connectors 3-2, 3-14
I
Identification 2-1
Indibag flap 3-13
1-2 |
Fresenius Medical Care 5008 OP 5/09.06 |
Chapter 1: Index
Info 4-3, 9-1
Infusion solution 6-7, 6-22
Infusion solutions, administering 6-7, 6-22
Initial start-up 2-6, 11-42 Intended use 2-4 International service 2-8
ISO-UF (Sequential therapy) 11-7, 11-52
IV pole 3-4, 3-5
K
Kinking warning 10-14
Kt/V 15-1
Kt/V warning 10-22
L
LAN (network) 3-15, 11-15, 22-1
Leakage sensor, extracorporeal blood module 3-8
Leakage sensor, filter chamber 3-4 LED/keys 3-6
Level detector 3-11, 11-11
Level, setting level in SN chamber 6-12
Level, setting the level in the venous bubble catcher 10-31
Line guide 3-10, 11-34, 11-36, 11-38, 11-40
Line guides 3-8
Line holder (for transport) 3-2 Line holder for SafeLine™ 3-9 Lines, removing all 10-30
Lines, removing during Preparation 10-28
Lines, removing during treatment 10-29
Loudspeaker 3-7
M
Manufacturer 2-8 Materials 11-17, 11-20 Materials used 11-17 Menu buttons 4-3 Menu panel 4-3
Menu structure, design 4-6
Message button 4-2 Messages 9-1 Micro bubbles 9-7
Micro bubbles removal 9-10 Micro bubbles, overriding 9-9 Miscellaneous 10-23 Monitor 3-1, 3-6, 3-7 Monitor arm 3-7
N
Network (LAN) 3-15, 11-15, 22-1 Numeric keypad 4-7
O
OCM 10-22, 11-13, 11-27, 15-1 OCM (menu) 15-3
Online (bolus) 6-2, 6-11, 10-21 ONLINE preparation 5-1
ONLINE preparation with SingleNeedle 5-31
ONLINEplus™ 3-9, 5-1, 5-31, 6-1, 6-9, 7-1, 7-9, 10-21, 11-24, 11-28, 16-1
Operating conditions 11-5 Operating mode 4-2 Operating mode indicator 3-6 Operating programs 11-7 Operator Setup 10-2
Optical detector 3-11, 5-9, 5-25, 5-39, 5-55, 11-11
Outage (power failure) 9-15 Outlet line 3-14
Override conditions 11-6 Overview (screen) 4-2
P
Page setup 3-3, 3-4 Particle filter, dialysate 3-4
Patient ID (treatment data sheet) 4-3
Patient, connecting with ONLINE 6-1
Patient, connecting with ONLINE and Single-Needle 6-9
Patient, disconnecting with ONLINE 7-1
Patient, disconnecting with ONLINE and Single-Needle 7-9
PatientCard 3-7, 10-20
Potential equalization 3-14, 11-42
Power connection (supply point) 3-2, 3-15
Power failure (outage) 9-15
Power failure and battery operation 9-15
Power failure and depleted battery 9-16
Power switch 3-15 Preparation 5-1, 11-7
Preparation with rinse solution bag 5-17
Pressure displays 4-3 Pressure holding test 11-8 Pressure tubing 3-12, 18-2
Prime collection bag 11-37, 11-41
Profiles 5-13, 5-29, 5-43, 5-59, 6-4, 6-6, 6-14, 6-21
Pulse 11-14
Pump segment 11-34, 11-36, 11-38, 11-40
Push handle 3-2
R
Rear view 3-2 Recessed handle 3-7
Recirculating adapter (SafeLine™) 11-35, 11-39
Recirculation 11-31
Recirculation measurement 11-14 Recycling 11-17
Reinfusion 7-1, 10-3 Repair 2-7
Residual disinfectant, checking 8-5
Restrictions 2-4
Rinse connector 11-35, 11-39 Rinse port 3-8
Rinse port catch (grey) 3-8 Rinse solution bag 11-36, 11-41 Rinse/reinfusion volume 10-3 Rocker switch 4-8
Room temperature 10-25 Rotor 3-10
Fresenius Medical Care 5008 OP 5/09.06 |
1-3 |
Chapter 1: Index
S
SafeLine™ 11-35, 11-39
SafeLine™ line guide 11-35, 11-39
SafeLine™ pump segment 11-35, 11-39
SafeLine™, connecting/retrofitting 10-30
SafeLine™, removing 10-29 Safety precautions 2-5 Safety precautions (basic) 2-5
Safety precautions (electric hazards) 2-6
Safety precautions, signification 2-2
Sampling 10-28
Screen 3-6, 4-2 Screen colors 4-4 Screen failure 9-17
Screen failure, no screen reaction 9-17
Screen failure, screen dark or display distorted 9-17
Screen saver 4-9 Screen, cleaning 8-5 Selection screen 4-1
Service Central Europe 2-8 Service door 3-2 ServiceCard 3-7
Setting via numeric keypad 4-7 Setting via rocker switch 4-8 Settings, SYSTEM SCREEN 10-1 Setup 10-2
Shunt door 3-4, 3-5 Shunt interlock 3-4 Side effects 2-4 Single programs 10-18
Single-Needle 3-12, 10-23, 11-13, 11-25, 11-29, 11-53
Single-Needle Click-Clack 10-23, 10-32, 11-12, 11-23
Single-Needle pressure port 3-12 Single-Needle pump 3-12 smartbag 24-1
SN chamber 11-13, 11-39, 11-41 SN line guide 11-39, 11-41
SN pressure line 11-39, 11-41 SN pump segment 11-39, 11-41
Sodium profiles 5-13, 5-29, 5-43, 5-59, 6-4, 6-6, 6-14, 6-21
Specifications 11-1, 11-44 Start-up requirements 2-6 Start-up screen 4-1 Status 4-2
Storage 11-16 Stroke volume 11-13
Substituate catch (blue) 3-8
Substituate connector (SafeLine™) 11-35, 11-39
Substituate port 3-8 Substituate pump 3-8 Substitution 10-21 Supply point 3-2, 3-15
Surface cleaning 8-5, 12-3 Symbols 11-54
System description 11-1, 11-22
T
T1 test 11-7
Technical documentation 2-7
Technical measurement checks (TMC) 2-6, 11-47, 11-54
Technical safety checks (TSC) 2-6, 11-47
Terms 11-52
TMC 2-6, 11-47, 11-54
Transmembrane pressure 11-8, 11-53
Transportation 11-16
Tray for disinfectant container 3-14 Treatment 6-1
Treatment data sheet 4-3 TSC 2-6, 11-47, 11-54
Tubing system, inserting with ONLINE 5-8
Tubing system, inserting with ONLINE in case of Single-Needle 5-38
Tubing system, inserting with rinse solution bag 5-24
Tubing system, inserting with rinse solution bag in case of SingleNeedle 5-54
Turning power off 8-6
Turning power on 5-1, 5-17, 5-31, 5-47
Type label 11-1
U
UF menu 5-13, 5-14, 5-28, 5-29, 5-43, 5-44, 5-58, 5-59
UF parameters 5-12, 5-28, 5-42, 5-58, 6-3, 6-6, 6-14, 6-21
UF profiles 5-13, 5-29, 5-43, 5-59, 6-4, 6-6, 6-14, 6-21
UF Timer I/O 4-3 UFK-Messung 11-9 Ultrafiltration 10-13, 11-8 User interface 10-14 UserCard 3-7
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Venous blood line 11-35, 11-36, 11-38, 11-40
Venous bubble catcher 5-9, 5-25, 5-39, 5-55, 11-35, 11-36, 11-38, 11-40
Venous injection site/collection site 11-34, 11-36, 11-38, 11-40
Venous line, removing 10-29
Venous measuring head (BTM) 3-12
Venous monitoring function 3-8, 3-11
Venous occlusion clamp 3-8
Venous patient connection 11-35, 11-36, 11-39, 11-40
Venous pressure 4-3
Venous pressure line 11-34, 11-36, 11-38, 11-40
Venous pressure measurement 11-11
Venous pressure port 3-9 Venous transducer 10-14 Vent (mixing chamber) 3-14
Vent (water inlet chamber) 3-14
W
Warning 9-1
Warranty 2-5
1-4 |
Fresenius Medical Care 5008 OP 5/09.06 |
Chapter 1: Index
Water alarms 11-53
Water supply 11-44, 11-45
Water supply (permeate) 3-14
Weekly programs 10-18
Weight 11-1
WET 23-1
Fresenius Medical Care 5008 OP 5/09.06 |
1-5 |
Chapter 1: Index
1-6 |
Fresenius Medical Care 5008 OP 5/09.06 |
Chapter 2: Important Information
2 Important Information
2.1Important Information on the Operating Instructions
2.1.1How to Use the Operating Instructions
Identification |
The document can be identified by the following information on the title |
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page and on the labels, if any: |
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– Software version of the system |
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– Edition of the technical document |
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– Part number of the technical document |
Page identification |
The page identification 1-3, for example, refers to Chapter 1, page 3. |
Editorial information |
The editorial information 1/01.05, for example, refers to: 1. edition, |
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January 2005. |
Changes |
Document changes will be released as new editions or supplements. In |
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general, this manual is subject to change without notice. |
Importance of the |
These Operating Instructions are part of the accompanying documents |
instructions |
and an integral part of the system. They contain information necessary |
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for the use of the system. |
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The Operating Instructions must be carefully studied before attempting |
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to operate the system. |
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Before the responsible organization may start operating the system, the |
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person responsible for the operation must have been instructed by the |
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manufacturer on how to use the system and must be thoroughly familiar |
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with the contents of the Operating Instructions. |
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The system may only be operated by persons certificated to have been |
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instructed on the proper operation and handling of the unit. |
Description of the options |
Chapters 15 to 28 describe the operation of the options. For further |
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information please refer to the appropriate chapters. (e.g. The SN |
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Specifications are listed in chapter 11 System Description.) |
Fresenius Medical Care 5008 OP 5/09.06 |
2-1 |
Chapter 2: Important Information
2.1.2Signification of the Safety Precautions
Explanation of the Caution and Note symbols used:
Caution
Advises the operator against certain procedures or actions that could cause damage to the equipment or may have adverse effects on individuals.
Note
Informs the operator that in case of a failure to follow the steps as described, a specific function will be executed incorrectly or will not be executed at all, or will not produce the desired effect.
2.1.3Signification of the Highlight Symbol
Explanation on the following symbol:
Here you will find hints on easy handling.
2-2 |
Fresenius Medical Care 5008 OP 5/09.06 |
Chapter 2: Important Information
2.2Important Information on the System
2.2.1Brief Description
Dialysis treatments with the hemodialysis system 5008 can be performed without any additional equipment. The hemodialysis system controls and monitors the dialysate circuit and the extracorporeal blood circuit.
The monitor comprises of four keys. All entries are made via a highresolution color monitor (touch screen). The current treatment data are shown on the display.
In the dialysate circuit, product water is heated, degassed, mixed with hemodialysis concentrate, and delivered to the dialyzer. Inflowing and outflowing quantities are balanced volumetrically. The pressure at the dialyzer is adjusted depending on the ultrafiltration rate selected and the type of dialyzer used.
The blood in the extracorporeal blood circuit is transported through the dialyzer. The blood can be continuously heparinized. An air bubble detector prevents infusion of air. Any dangerous loss of blood is prevented by a blood leak detector, a fluid detector and by monitoring the venous return pressure. The arterial pressure monitoring unit detects an aspiration of the needle in the vessel.
The hemodialysis system 5008 is designed for both acetate dialysis and bicarbonate dialysis. The mixing ratio, the Na+ concentration and the bicarbonate concentration may be programmed within certain limits. The hemodialysis system allows programming of Na and UF profiles.
ISO-UF (ultrafiltration without dialysate flow) may be performed.
The dialysate flow can be adjusted from 100 to 1000 ml/min, in increments of 100 ml/min. The AutoFlow function automatically regulates the dialysate flow, depending on the dialyzer type and blood flow.
The 5008 hemodialysis system reflects the latest state of technology. It is equipped with all safety systems required for its function and for patient safety. It complies with the requirements of EN 60601-1 (IEC 601-1). The BPM (optional) complies with the EN 1060-1 standard for non-invasive sphygmomanometers, Part 1 General Requirements.
The 5008 hemodialysis system is classified as Class II b (MDD) equipment.
Fresenius Medical Care 5008 OP 5/09.06 |
2-3 |
Chapter 2: Important Information
2.2.2Intended Use
Fields of application
The 5008 hemodialysis system is designed for performing chronic and acute hemodialysis. It can be used in home dialysis, hemodialysis and limited care centers and clinical hemodialysis.
Side effects
Hemodialysis therapies occasionally cause hypotension, nausea, vomiting and cramps in some patients. In addition, the package inserts enclosed with the consumables (e.g. hemodialysis concentrates, dialyzers) must be observed.
Contraindications
–Hyperkalemia (only with potassium-containing hemodialysis concentrates)
–Hypokalemia (only with potassium-free hemodialysis concentrates)
–Uncontrollable coagulation anomalies
A different method of extracorporeal treatment may be indicated in hemodynamically unstable patients.
Restrictions
None
2.2.3Target Group
The system may only be installed, operated and used by persons with the appropriate training, knowledge and experience.
2.2.4Duties of the Responsible Organization
The responsible organization assumes the following responsibilities:
–Compliance with the national or local installation, operation, use and maintenance regulations
–Respect of the accident prevention regulations
–Correct and safe state of the system
–Permanent availability of the Operating Instructions
2-4 |
Fresenius Medical Care 5008 OP 5/09.06 |
Chapter 2: Important Information
2.2.5Disclaimer of Liability
The system has been approved for use with the consumables and accessories listed in the Operating Instructions.
Should the responsible organization wish to use other consumables and accessories than those listed in the Operating Instructions, the responsibility to ensure the correct function of the system lies exclusively with the responsible organization. The applicable legal regulations must be complied with (e.g. in Germany the Medical Device Directive, MDD and the MPBetreibV = German regulation for the operation of medical products).
The manufacturer does not assume any responsibility or liability for personal injury or other damage and excludes any warranty for damage to the system resulting from the use of non-approved or unsuitable consumables or accessories.
2.2.6Guarantee / Warranty
Guarantee
For guarantee refer to the respective sales contracts.
Warranty
The customer's rights of warranty depend on the applicable legal regulations.
2.2.7Safety Precautions
Basic safety precautions
Caution
When using a RO unit or CDS the following must be observed: Operating Instructions of the RO unit or CDS used.
When cleaning the RO unit and its supply lines, the hemodialysis system must be disconnected from the RO unit at the water supply.
During cleaning of the CDS distribution tubings, the hemodialysis system must be separated from the CDS.
Fresenius Medical Care 5008 OP 5/09.06 |
2-5 |
Chapter 2: Important Information
Electric hazards
Caution
The use of additional extension cables or multiway sockets / connectors is prohibited.
2.2.8Additional Optional Equipment Supplied by Fresenius Medical Care
–DIASAFE®plus
–AquaUNO (single station ´reverse osmosis unit)
For connecting the AquaUNO to the 5008 hemodialysis system, the two following cables must be used:
Control cable connection set: 3 meters (part no.: M37 525 1) or 11 meters (part no.: M37 510 1)
Adapter cable AquaUNO - 5008 (part no.: M36 940 1)
2.2.9Initial Start-Up
Prior to the initial start-up thoroughly study the information given in chapter 11.
2.2.10 Start-Up Requirements
The 5008 hemodialysis system must be in a perfect state. If the 5008 hemodialysis system shows signs of mechanical damage preventing safe operation, stop using the machine. Applied parts that are damaged must be replaced.
2.2.11 Operation
The following must be observed when entering parameters:
The parameters entered must be verified by the operator, i.e. the operator must check that the values entered are correct. If the verification reveals a deviation between the desired parameters and the parameters displayed on the system, the setting must be corrected before activating the function.
The actual values displayed must be compared with the desired values specified.
2.2.12 Technical Safety Checks (TSC), Technical Measurement Checks (TMC)
The technical safety checks and technical measurement checks required must be performed every 2 years.
2-6 |
Fresenius Medical Care 5008 OP 5/09.06 |
Chapter 2: Important Information
2.2.13 Repair
Assembly, extensions, adjustments, modifications or repairs may only be carried out by the manufacturer or persons authorized by him.
2.2.14 Technical Documentation
Upon request the manufacturer will provide circuit diagrams, descriptions, spare parts lists and other documents. These are intended to support trained personnel in servicing and repairing the machine.
The following is also available on request:
–Test procedure by which the effectiveness of sterilization or disinfection has been verified.
–Comments, concerning the expected recirculation of the blood flow in the extracorporeal circuit in Single-Needle treatments, if the recommended administration sets, dialyzers, fistula needles and catheters are used.
Fresenius Medical Care 5008 OP 5/09.06 |
2-7 |
Chapter 2: Important Information
2.3Addresses
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Please address any inquiries to: |
Manufacturer |
Fresenius Medical Care AG & Co. KGaA |
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D-61346 Bad Homburg |
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+49 (0)6172/609-0 |
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www.fmc-ag.com |
Service |
Fresenius Medical Care |
Central Europe |
Deutschland GmbH |
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Geschäftsbereich Zentraleuropa |
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Kundendienst / Servicecenter |
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Steinmühlstraße 24 |
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61352 Bad Homburg |
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Germany |
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Phone: +49 6172 609-7100 |
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Fax: +49 6172 609-7102 |
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E-mail: ServicecenterD@fmc-ag.com |
International |
Fresenius Medical Care |
Service |
Deutschland GmbH |
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Service Support International |
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Hafenstrasse 9 |
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D-97424 Schweinfurt |
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Germany |
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Phone: +49 9721 678-333 (hotline) |
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Fax: +49 9721 678-130 |
Local Service |
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2-8 |
Fresenius Medical Care 5008 OP 5/09.06 |
Chapter 3: Design
3 Design
3.1Front View
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Monitor |
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Extracorporeal blood module |
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Hydraulics |
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Fresenius Medical Care 5008 OP 5/09.06 |
3-1 |
Chapter 3: Design
3.2Rear View
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3-2 |
Fresenius Medical Care 5008 OP 5/09.06 |
Chapter 3: Design
3.3Lateral View, Left Side
1 Cover, tray, cuff holder or shunt interlock
2 Concentrate rack (extractable)
3 Brake
Remove the cover from the tray: (a) Push the cover down and turn it. (b) Pull the cover out.
a b
To extract the concentrate rack:
1 Push with your foot from the front against the rack.
To retract the concentrate rack:
Push with your foot from the front against the rack until it clicks into place.
To apply or release the brake:
(a) Push the lever down to apply the brake. (b) Push the lever down to release the brake.
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b |
2
3
Fresenius Medical Care 5008 OP 5/09.06 |
3-3 |
Chapter 3: Design
3.4Lateral View, Right Side
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IV pole |
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Dialyzer holder |
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Shunt door for dialysate lines |
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Shunt interlock |
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Dialysate return line |
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Dialysate supply line |
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Concentrate rack (extractable) |
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Brake |
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Leakage sensor, filter chamber |
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Particle filter, dialysate |
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3-4 |
Fresenius Medical Care 5008 OP 5/09.06 |
Chapter 3: Design
To adjust the IV pole:
Push the knob (a) upwards and
bsimultaneously extract or retract the IV pole (b).
a
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Dialyzer holder: |
b |
c |
Push the lever (a) to the left to insert the |
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dialyzer. The dialyzer can be moved to any |
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desired position (b). Press or pull the lever (c) |
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to swivel the dialyzer holder to the right. |
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(When the right-hand door is opened, the |
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dialyzer holder will automatically move to the |
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right.) |
bTo open or close the shunt door:
Open the shunt door by flipping it to the top (a). Close the shunt door by flipping it down
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(b). |
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To remove the dialysate couplings:
Push the lever down and hold it, and remove the dialysate coupling.
To move the hemodialysis system:
The hemodialysis system can be moved in all directions.
Fresenius Medical Care 5008 OP 5/09.06 |
3-5 |
Chapter 3: Design
3.5Monitor Front
7
1
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6
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1Display failure sensor (hidden)
2On/Off LED/key (green)
(LED is illuminated – system in operation. LED is flashing – system is connected to power supply, standby.)
3Blood system Stop LED/key (red)
4Blood system Start LED/key (green)
5Mute LED/key (red)
(LED is illuminated – audible alarm suppressed. LED is flashing – audible alarm active.)
6Screen
7Operating mode indicator (green, yellow, red) LED is green to indicate correct operation. LED is yellow in case of a warning or an info. LED is yellow and flashing in Emergency mode. LED is red in case of an alarm.
LED is not illuminated during the cleaning programs.
3-6 |
Fresenius Medical Care 5008 OP 5/09.06 |
Chapter 3: Design
3.6Monitor Rear
1
2
3
4
1Card receptacle
(for PatientCard/UserCard/ServiceCard)
2Loudspeaker
3Recessed handle
4Monitor arm
To move the monitor:
To bring the monitor into the desired position, it can be swiveled about three axes (a), (b), (c).
a |
b |
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c
(a) To move it, hold the monitor at the points shown.
(b) Insert card.
a |
b |
Fresenius Medical Care 5008 OP 5/09.06 |
3-7 |
Chapter 3: Design
3.7Extracorporeal Blood Module
1
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1Line holder
2Blood pump
3Heparin pump (if present)
4Arterial pressure measurement unit
5Substituate pump
6Arterial occlusion clamp
7Substituate catch/lock (blue)
8Substituate port, hidden by the substituate catch (blue)
9Rinse port, hidden by the rinse port catch (grey)
10Rinse port catch (grey)
11Groove
12Leakage sensor, extracorporeal blood module
13Venous occlusion clamp
14Venous monitoring function (optical detector, air bubble detector)
15Locator for venous bubble catcher
16Venous monitoring function (level detector)
3-8 |
Fresenius Medical Care 5008 OP 5/09.06 |
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