Fresenius Medical Care 5008 User manual

5008
Hemodialysis System
Operating Instructions
Software version: 3.52
Edition: 5/09.06
Part no.: M38 816 1
0123
Fresenius Medical Care
!!
!Caution!
These Operating Instructions in pdf-
format are for information only.
They are not a replacement for the
Operating Instructions supplied with
the machine/device and options.

Table of Contents Page
Fresenius Medical Care 5008 OP 5/09.06 iii
1Index
2 Important 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
3Design
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
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
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

Table of Contents Page
iv Fresenius Medical Care 5008 OP 5/09.06
6 Treatment
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
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
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

Table of Contents Page
Fresenius Medical Care 5008 OP 5/09.06 v
10 Other Functions
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

Table of Contents Page
vi Fresenius Medical Care 5008 OP 5/09.06
12.7 Surface Disinfection / Surface Cleaning................................................................................ 12-3
12.8 Disinfectants for the Hydraulics............................................................................................. 12-3
12.9 Disinfectant Indicators ............................................................................................................ 12-4
13 Certificates
13.1 EC Certificate ........................................................................................................................... 13-1
14 Appendix
14.1 Bibliography............................................................................................................................. 14-1
15 Option OCM (Online Clearance Monitoring)
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)
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

Table of Contents Page
Fresenius Medical Care 5008 OP 5/09.06 vii
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
19 Option CBPM
20 Option 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
22.1 To Be Observed Before Using the Network .......................................................................... 22-1
22.2 DataXchange Panel ................................................................................................................. 22-1
23 Options BLK, WET
23.1 To be Observed Before Using the BLK, WET Options......................................................... 23-1
23.2 BLK ........................................................................................................................................... 23-1
23.3 WET........................................................................................................................................... 23-2

Table of Contents Page
viii Fresenius Medical Care 5008 OP 5/09.06
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

Chapter 1: Index
Fresenius Medical Care 5008 OP 5/09.06 1-1
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

Chapter 1: Index
1-2 Fresenius Medical Care 5008 OP 5/09.06
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

Chapter 1: Index
Fresenius Medical Care 5008 OP 5/09.06 1-3
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 Single-
Needle 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

Chapter 1: Index
1-4 Fresenius Medical Care 5008 OP 5/09.06
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 Single-
Needle 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
V
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

Chapter 1: Index
Fresenius Medical Care 5008 OP 5/09.06 1-5
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

Chapter 1: Index
1-6 Fresenius Medical Care 5008 OP 5/09.06

Chapter 2: Important Information
Fresenius Medical Care 5008 OP 5/09.06 2-1
2 Important Information
2.1 Important Information on the Operating Instructions
2.1.1 How to Use the Operating Instructions
Identification The document can be identified by the following information on the title
page and on the labels, if any:
– Software version of the system
– Edition of the technical document
– Part number of the technical document
Page identification The page identification 1-3, for example, refers to Chapter 1, page 3.
Editorial information The editorial information 1/01.05, for example, refers to: 1. edition,
January 2005.
Changes Document changes will be released as new editions or supplements. In
general, this manual is subject to change without notice.
Importance of the
instructions
These Operating Instructions are part of the accompanying documents
and an integral part of the system. They contain information necessary
for the use of the system.
The Operating Instructions must be carefully studied before attempting
to operate the system.
Before the responsible organization may start operating the system, the
person responsible for the operation must have been instructed by the
manufacturer on how to use the system and must be thoroughly familiar
with the contents of the Operating Instructions.
The system may only be operated by persons certificated to have been
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
information please refer to the appropriate chapters. (e.g. The SN
Specifications are listed in chapter 11 System Description.)

Chapter 2: Important Information
2-2 Fresenius Medical Care 5008 OP 5/09.06
2.1.2 Signification of the Safety Precautions
Explanation of the Caution and Note symbols used:
2.1.3 Signification of the Highlight Symbol
Explanation on the following symbol:
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.
Here you will find hints on easy handling.

Chapter 2: Important Information
Fresenius Medical Care 5008 OP 5/09.06 2-3
2.2 Important Information on the System
2.2.1 Brief 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 high-
resolution 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.

Chapter 2: Important Information
2-4 Fresenius Medical Care 5008 OP 5/09.06
2.2.2 Intended Use
OFields 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.
OSide 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.
OContraindications
– 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.
ORestrictions
None
2.2.3 Target Group
The system may only be installed, operated and used by persons with
the appropriate training, knowledge and experience.
2.2.4 Duties 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

Chapter 2: Important Information
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2.2.5 Disclaimer 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.
2.2.6 Guarantee / Warranty
OGuarantee
For guarantee refer to the respective sales contracts.
OWarranty
The customer's rights of warranty depend on the applicable legal
regulations.
2.2.7 Safety Precautions
OBasic 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.

Chapter 2: Important Information
2-6 Fresenius Medical Care 5008 OP 5/09.06
OElectric hazards
2.2.8 Additional 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)
2.2.9 Initial 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.
Caution
The use of additional extension cables or multiway sockets / connectors
is prohibited.