Fresenius 5008 User manual

5008

Caution!

These Operating Instructions in pdfformat are for information only. They are not a replacement for the Operating Instructions supplied with the machine/device and options.

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

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

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Table of Contents Page

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

iv Fresenius Medical Care 5008 OP 5/09.06

Table of Contents Page

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

10.5 Changing the DIASAFE

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

plus ............................................................................................... 10-27

.......................................................................................... 10-26

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

Fresenius Medical Care 5008 OP 5/09.06 v

plus............................................................................................... 12-2

Table of Contents Page

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

vi Fresenius Medical Care 5008 OP 5/09.06

Table of Contents Page

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

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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

1 Index

How to use the index: Index entry 1-3, for example, refers to chapter 1, page 3

Chapter 1: Index

Abbreviations 11-53

ABD handling (air removal)

Acetate dialysis 5-50

Additional optional equipment

Addresses

Air bubble detector

Air removal

Alarm

9-1

Alarm limits, management

Alarm output (staff call)

Alarm override

Alarm processing

Anticoagulation

AquaUNO

Arterial blood line 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

Arterial measuring head (BTM) 3-12

Arterial occlusion clamp

Arterial patient connection 11-36, 11-38, 11-40

Arterial pressure

Arterial pressure dome 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

Audible alarm

Audible alarm suppression

Auto On

AutoFlow

10-18

5-4, 5-20, 5-34,

2-8

3-11, 11-11

9-3

11-7

9-1, 10-14

10-3

2-6, 3-15, 11-6

11-34, 11-36,

4-3

11-12

11-9

9-3

2-6

9-14

3-15

10-29

3-8

11-34,

5-8, 5-24,

9-15

11-6

Auto-Single-Needle

Auto-sub

10-21

11-13

Barrel holder with syringe detector 3-10

Battery

bibag® 11-27

bibag® port

bibag®, connecting 5-34, 5-50

bibag®, emptying/changing

Bibliography

Bicarbonate dialysis 5-33, 5-49

Bicarbonate flap

Bicarbonate suction tube (blue) 3-13

BLK

Blood alarms

Blood flow

Blood leak detector

Blood lines

Blood lines (description)

Blood lines with ONLINEplus™ 11-34

Blood lines with ONLINEplus™ Single-Needle

Blood lines with rinse solution bag 11-36

Blood Lines with Single Needle with rinse solution bags

Blood lines, removing

Blood pressure

Blood pressure cuff

Blood pressure cuffs

Blood pressure measurement 18-1

Blood pump

Body temperature control

11-16, 11-44 5-20, 5-34, 5-50, 7-3, 7-6,

3-13

5-4, 5-20,

14-1

5-3, 5-19,

3-13

23-1

11-23, 11-52

4-3

11-8

12-1

11-38

4-3, 11-13

3-12

18-1

3-8, 3-10, 10-2

10-26

11-34

11-40

7-3, 7-7

11-14

BPM 3-12, 10-24, 11-30, 18-1

BPM pressure port

Bracket (heparin pump)

Brake

3-3, 3-4

Brief description

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

BVM

3-12, 10-24, 11-25, 11-32,

21-1

BVM measuring head

3-12

3-10

2-3

11-52

3-12

Card receptacle 3-7

Central delivery system (CDS) 5-4, 5-20, 5-34, 5-50

Certificates

Circulation

Clamping lever (heparin pump) 3-10

Cleaning (basic requirements)

Cleaning program

Cleaning programs

Concentrate flap

Concentrate rack 5-19, 5-33, 5-49

Concentrate suction tube (red) 3-13

Concentrate supply, selecting 5-19, 5-33, 5-49

Concentrates 5-49, 11-9

Conductivity

Conductivity alarm

Connection, venous pressure line 11-34, 11-36, 11-38, 11-40

Connector for BIC, blue

Connector for CDS 1, red

13-1

10-30

8-3, 8-4

11-8

3-13

3-3, 3-4, 5-3,

5-3, 5-19, 5-33,

11-52

9-15

8-1

5-3,

3-14

Fresenius Medical Care 5008 OP 5/09.06 1-1

Chapter 1: Index

Connector for CDS 2, red 3-14

Connector postdilution 11-39

Connector pre/postdilution (SafeLine™)

Connector predilution 11-39

Connector, SN pressure line 11-39, 11-41

Consumables

Contraindications

Course of the treatment

Cuff holder

11-35, 11-39

12-1

3-12

11-35,

2-4

4-5

Data entry, examples (treatment data)

4-7

Decalcification

Define options

Definitions and terms

Degreasing

Design

Dialysate couplings

Dialysate flow

Dialysate flow status indicator

Dialysate lines 5-41, 5-56

Dialysate menu 5-29, 5-42, 5-44, 5-57, 5-59

Dialysate parameters 5-42, 5-57, 6-3, 6-6, 6-13, 6-20

Dialysate particle filter, cleaning 10-28

Dialysate return line

Dialysate supply line

Dialysate temperature

Dialyzer 11-40

Dialyzer connector (arterial blood line)

Dialyzer connector (venous blood line)

Dialyzer holder

Dialyzer, emptying

Dialyzers

DIASAFE®plus

DIASAFE®plus, changing

3-1

11-34, 11-36, 11-38, 11-40

12-3

10-15

11-52

12-4

3-5

11-9

4-2

3-4, 5-11, 5-26,

5-12, 5-14, 5-27,

5-12, 5-27,

3-4

11-9

11-34, 11-36, 11-38,

3-4, 3-5

7-2, 7-6

12-1

11-12, 12-2

10-27

Dimensions

Disclaimer of liability

Disinfectant connector, black

Disinfectant connector, yellow 3-14

Disinfectant container, connecting 8-2

Disinfectant indicators

Disinfectants

Disinfection

Disinfection program

Display failure sensor

Double-Needle 5-47, 6-1, 6-5, 7-1, 7-5

Duties of the responsible organization

11-1

2-5

3-14

12-4

12-3

8-1

8-3, 8-4

3-6

5-1, 5-17, 5-31,

2-4

EBM 11-53

EcoFlow 11-10

Electrical safety

Electrical supply

Electromagnetic compatibility (EMC)

EMC

Emergency

Emergency button 10-26

Emergency operation

Environmental compatibility

External connection options 3-15, 11-6

Extracorporeal blood module (EBM) 5-24, 5-26, 5-38, 5-41, 5-54, 5-56

5-12, 5-27, 5-42, 5-57,

11-2

11-3, 11-53

10-19

4-3, 10-19,

9-16, 9-17

11-17

3-2,

3-1, 3-8, 3-12, 5-8, 5-11,

Fan filter (service door) 3-2

Fields of application

Filter 1 - DIASAFE®plus

Filter 2 - ONLINEplus™

Filter chamber

Fixation for the plunger (heparin pump)

3-10

Flow alarm

Flow diagram

11-11

2-4

3-4

11-26

Flush

11-8

Flush drain

Front view

Fuses

General operation philosophy 4-3

Graphical user interface

Grip handle (heparin pump)

Groove

Guarantee

Guarantee / warranty

3-14

3-1

11-2

3-8

2-5

Handle 9-16, 9-17

Handle for an emergency operation

Header bar

Hemodialysis concentrates

Hemodialysis system, turning off 8-6

Hemodialysis system, turning on 5-1, 5-17, 5-31, 5-47

Heparin (menu) 5-60

Heparin line 11-41

Heparin menu

Heparin pump 11-22

Heparin pump parameters 5-30, 5-45, 5-60, 6-4, 6-7, 6-15, 6-21

Heparin status indicator

Heparin syringe 5-55, 11-35, 11-36, 11-39, 11-41, 12-2

Holder for disinfectant container 3-14

Holder for SN chamber

Hydraulics

Hydraulics connectors

3-10

4-4

5-15, 5-30, 5-45,

11-35, 11-36, 11-39,

4-3 3-8, 3-10, 11-12,

5-9, 5-25, 5-39,

3-1, 3-2, 3-13, 3-14

Identification 2-1

Indibag flap

3-13

4-1

3-10

2-5

12-2

5-15,

4-3

3-12

3-2, 3-14

1-2 Fresenius Medical Care 5008 OP 5/09.06

Chapter 1: Index

Info 4-3, 9-1

Infusion solution

Infusion solutions, administering 6-7, 6-22

Initial start-up

Intended use

International service

ISO-UF (Sequential therapy) 11-52

IV pole

3-4, 3-5

6-7, 6-22

2-6, 11-42

2-4

2-8

11-7,

Kinking warning 10-14

Kt/V

15-1

Kt/V warning

10-22

LAN (network) 3-15, 11-15, 22-1

Leakage sensor, extracorporeal blood module

Leakage sensor, filter chamber

LED/keys

Level detector

Level, setting level in SN chamber 6-12

Level, setting the level in the venous bubble catcher

Line guide 11-38, 11-40

Line guides

Line holder (for transport)

Line holder for SafeLine™

Lines, removing all

Lines, removing during Preparation

Lines, removing during treatment 10-29

Loudspeaker

3-8

3-4

3-6

3-11, 11-11

10-31

3-10, 11-34, 11-36,

3-8

3-2

3-9

10-30

10-28

3-7

Manufacturer 2-8

Materials

Materials used

Menu buttons

Menu panel

Menu structure, design

11-17, 11-20

11-17

4-3

4-6

Message button

Messages

Micro bubbles

Micro bubbles removal

Micro bubbles, overriding

Miscellaneous

Monitor

Monitor arm

3-1, 3-6, 3-7

4-2

9-1

9-7

9-10

9-9

10-23

3-7

Network (LAN) 3-15, 11-15, 22-1

Numeric keypad

4-7

OCM 10-22, 11-13, 11-27, 15-1

OCM (menu)

Online (bolus)

ONLINE preparation

ONLINE preparation with SingleNeedle

ONLINEplus™ 6-1, 6-9, 7-1, 7-9, 10-21, 11-24, 11-28, 16-1

Operating conditions

Operating mode

Operating mode indicator

Operating programs

Operator Setup

Optical detector 5-39, 5-55, 11-11

Outage (power failure)

Outlet line

Override conditions

Overview (screen)

15-3

6-2, 6-11, 10-21

5-1

5-31

3-9, 5-1, 5-31,

11-5

4-2

3-6

11-7

10-2

3-11, 5-9, 5-25,

9-15

3-14

11-6

4-2

Page setup 3-3, 3-4

Particle filter, dialysate

Patient ID (treatment data sheet) 4-3

Patient, connecting with ONLINE 6-1

Patient, connecting with ONLINE and Single-Needle

Patient, disconnecting with ONLINE

7-1

3-4

6-9

Patient, disconnecting with ONLINE and Single-Needle

PatientCard

Potential equalization

Power connection (supply point) 3-2, 3-15

Power failure (outage)

Power failure and battery operation

Power failure and depleted battery 9-16

Power switch

Preparation

Preparation with rinse solution bag 5-17

Pressure displays

Pressure holding test

Pressure tubing

Prime collection bag

Profiles 6-4, 6-6, 6-14, 6-21

Pulse

Pump segment 11-38, 11-40

Push handle

3-7, 10-20

9-15

3-15

5-1, 11-7

4-3

3-12, 18-2

5-13, 5-29, 5-43, 5-59,

11-14

11-34, 11-36,

3-2

Rear view 3-2

Recessed handle

Recirculating adapter (SafeLine™) 11-35, 11-39

Recirculation

Recirculation measurement

Recycling

Reinfusion

Repair

Residual disinfectant, checking 8-5

Restrictions

Rinse connector

Rinse port

Rinse port catch (grey)

Rinse solution bag

Rinse/reinfusion volume

Rocker switch

Room temperature

Rotor

11-17

7-1, 10-3

2-7

3-8

3-10

3-7

11-31

2-4

11-35, 11-39

11-36, 11-41

4-8

10-25

7-9

3-14, 11-42

9-15

11-8

11-37, 11-41

11-14

3-8

10-3

Fresenius Medical Care 5008 OP 5/09.06 1-3

Chapter 1: Index

SafeLine™ 11-35, 11-39

SafeLine™ line guide 11-39

SafeLine™ pump segment 11-39

SafeLine™, connecting/retrofitting 10-30

SafeLine™, removing

Safety precautions

Safety precautions (basic)

Safety precautions (electric hazards)

Safety precautions, signification 2-2

Sampling

Screen

Screen colors

Screen failure

Screen failure, no screen reaction 9-17

Screen failure, screen dark or display distorted

Screen saver

Screen, cleaning

Selection screen

Service Central Europe

Service door

ServiceCard

Setting via numeric keypad

Setting via rocker switch

Settings, SYSTEM SCREEN

Setup

Shunt door

Shunt interlock

Side effects

Single programs

Single-Needle 11-25, 11-29, 11-53

Single-Needle Click-Clack 10-32, 11-12, 11-23

Single-Needle pressure port

Single-Needle pump

smartbag

SN chamber

SN line guide

2-6

10-28

3-6, 4-2

4-4 9-17

4-9

3-2

3-7

10-2

3-4, 3-5

2-4

3-12, 10-23, 11-13,

24-1

11-13, 11-39, 11-41

11-39, 11-41

11-35,

10-29

2-5

9-17

8-5 4-1

2-8

4-7

4-8

10-1

3-4

10-18

10-23,

3-12

SN pressure line

SN pump segment

Sodium profiles 5-59, 6-4, 6-6, 6-14, 6-21

Specifications

Start-up requirements

Start-up screen

Status

4-2

Storage

Stroke volume

Substituate catch (blue)

Substituate connector (SafeLine™)

Substituate port

Substituate pump

Substitution

Supply point

Surface cleaning

Symbols

System description

11-16

11-54

11-39, 11-41

5-13, 5-29, 5-43,

11-1, 11-44

4-1

11-13

11-35, 11-39

3-8

10-21

3-2, 3-15

8-5, 12-3

11-1, 11-22

T1 test 11-7

Technical documentation

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 11-53

Transportation

Tray for disinfectant container

Treatment

Treatment data sheet

TSC

2-6, 11-47, 11-54

Tubing system, inserting with ONLINE

Tubing system, inserting with ONLINE in case of Single-Needle 5-38

Tubing system, inserting with rinse solution bag

Tubing system, inserting with rinse solution bag in case of SingleNeedle

5-54

11-16

6-1

5-8

5-24

2-6

3-8

4-3

2-7

11-8,

3-14

Turning power off

Turning power on 5-47

Type label

11-1

8-6

5-1, 5-17, 5-31,

UF menu 5-13, 5-14, 5-28, 5-29, 5-43, 5-44, 5-58, 5-59

UF parameters 5-58, 6-3, 6-6, 6-14, 6-21

UF profiles 6-4, 6-6, 6-14, 6-21

UF Timer I/O

UFK-Messung

Ultrafiltration

User interface

UserCard

5-12, 5-28, 5-42,

5-13, 5-29, 5-43, 5-59,

4-3

11-9

10-13, 11-8

10-14

3-7

Venous blood line 11-35, 11-36, 11-38, 11-40

Venous bubble catcher 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

Venous measuring head (BTM) 3-12

Venous monitoring function 3-11

Venous occlusion clamp

Venous patient connection 11-36, 11-39, 11-40

Venous pressure

Venous pressure line 11-36, 11-38, 11-40

Venous pressure measurement 11-11

Venous pressure port

Venous transducer

Vent (mixing chamber)

Vent (water inlet chamber)

4-3

10-14

Warning 9-1

Warranty

2-5

5-9, 5-25,

10-29

3-8,

3-8

11-35,

11-34,

3-9

3-14

1-4 Fresenius Medical Care 5008 OP 5/09.06

Water alarms 11-53

Water supply

Water supply (permeate)

Weekly programs

Weight

WET

23-1

11-44, 11-45

10-18

11-1

Chapter 1: Index

3-14

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

2.1 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

Description of the options Chapters 15 to 28 describe the operation of the options. For further

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.

information please refer to the appropriate chapters. (e.g. The SN Specifications are listed in chapter 11 System Description.)

Fresenius Medical Care 5008 OP 5/09.06 2-1

Chapter 2: Important Information

2.1.2 Signification 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.

2.1.3 Signification 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

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 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.

Chapter 2: Important Information

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 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.

concentration and the

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

2.2.2 Intended Use

O Fields of application

O Side effects

O Contraindications

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.

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.

– 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.

O Restrictions

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

2-4 Fresenius Medical Care 5008 OP 5/09.06

2.2.5 Disclaimer of Liability

2.2.6 Guarantee / Warranty

Chapter 2: Important Information

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.

O Guarantee

O Warranty

2.2.7 Safety Precautions

O Basic safety precautions

For guarantee refer to the respective sales contracts.

The customer's rights of warranty depend on the applicable legal regulations.

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

O Electric hazards

Caution

The use of additional extension cables or multiway sockets / connectors is prohibited.

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

2.2.10 Start-Up Requirements

2.2.11 Operation

Prior to the initial start-up thoroughly study the information given in chapter 11.

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.

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

2.2.13 Repair

2.2.14 Technical Documentation

Chapter 2: Important Information

Assembly, extensions, adjustments, modifications or repairs may only be carried out by the manufacturer or persons authorized by him.

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

2.3 Addresses

Manufacturer Fresenius Medical Care AG & Co. KGaA

Please address any inquiries to:

D-61346 Bad Homburg +49 (0)6172/609-0 www.fmc-ag.com

Service Central Europe

International Service

Local Service

Fresenius Medical Care Deutschland GmbH Geschäftsbereich Zentraleuropa Kundendienst / Servicecenter Steinmühlstraße 24 61352 Bad Homburg Germany Phone: +49 6172 609-7100 Fax: +49 6172 609-7102 E-mail: ServicecenterD@fmc-ag.com

Fresenius Medical Care Deutschland GmbH Service Support International Hafenstrasse 9 D-97424 Schweinfurt Germany Phone: +49 9721 678-333 (hotline) Fax: +49 9721 678-130

2-8 Fresenius Medical Care 5008 OP 5/09.06

3Design

3.1 Front View

Chapter 3: Design

1 Monitor

2 Extracorporeal blood module

3 Hydraulics

Fresenius Medical Care 5008 OP 5/09.06 3-1

Chapter 3: Design

3.2 Rear View

1 Monitor

2 External connection options

3 Push handle

4 Fan filter (service door)

5 Power connection (supply point)

6 Line holder (for transport)

7 Service door

8 Hydraulic connectors

3-2 Fresenius Medical Care 5008 OP 5/09.06

3.3 Lateral View, Left Side

Chapter 3: Design

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.

To extract the concentrate rack:

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.

Fresenius Medical Care 5008 OP 5/09.06 3-3

Chapter 3: Design

3.4 Lateral View, Right Side

1 IV pole

2 Dialyzer holder

3 Shunt door for dialysate lines

4 Shunt interlock

5 Dialysate return line

(dialyzer coupling blue)

6 Dialysate supply line

(dialyzer coupling red)

7 Concentrate rack (extractable)

8 Brake

9 Leakage sensor, filter chamber

10 Particle filter, dialysate

11 Filter 1 – DIASAFE

plus, right

12 Filter 2 – ONLINEplus™, left

13 Door, filter chamber

14 Filter chamber

3-4 Fresenius Medical Care 5008 OP 5/09.06

Chapter 3: Design

To adjust the IV pole: Push the knob (a) upwards and

simultaneously extract or retract the IV pole (b).

Dialyzer holder:

Push the lever (a) to the left to insert the

dialyzer. The dialyzer can be moved to any desired position (b). Press or pull the lever (c) to swivel the dialyzer holder to the right.

(When the right-hand door is opened, the dialyzer holder will automatically move to the right.)

To 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

(b).

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

3.5 Monitor Front

1 Display failure sensor (hidden)

2On/Off LED/key (green)

(LED is illuminated – system in operation. LED is flashing – system is connected to power supply, standby.)

3 Blood system Stop LED/key (red)

4 Blood system Start LED/key (green)

5Mute LED/key (red)

(LED is illuminated – audible alarm suppressed. LED is flashing – audible alarm active.)

6 Screen

7 Operating 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

3.6 Monitor Rear

Chapter 3: Design

1 Card receptacle

(for PatientCard/UserCard/ServiceCard)

2 Loudspeaker

3 Recessed handle

4 Monitor arm

To move the monitor: To bring the monitor into the desired position, it can be swiveled about three axes (a), (b), (c).

(a) To move it, hold the monitor at the points shown.

(b) Insert card.

Fresenius Medical Care 5008 OP 5/09.06 3-7

Chapter 3: Design

3.7 Extracorporeal Blood Module

1 Line holder

2 Blood pump

3 Heparin pump (if present)

4 Arterial pressure measurement unit

5 Substituate pump

6 Arterial occlusion clamp

7 Substituate catch/lock (blue)

8 Substituate port, hidden by the substituate catch (blue)

9 Rinse port, hidden by the rinse port catch (grey)

10 Rinse port catch (grey)

11 Groove

12 Leakage sensor, extracorporeal blood module

13 Venous occlusion clamp

14 Venous monitoring function (optical detector, air bubble detector)

15 Locator for venous bubble catcher

16 Venous monitoring function (level detector)

3-8 Fresenius Medical Care 5008 OP 5/09.06

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