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4008 S

hemodialysis device

Operating Instructions
Software version: 11.1
Edition: 4/12.10
Part no.: M44 475 1
0123

Fresenius Medical Care


Table of contents

1 Index

2 Important information
2.1 How to use the Operating Instructions ................................................................................... 2-1
2.2 Significance of the warning...................................................................................................... 2-2
2.3 Significance of the note ............................................................................................................ 2-2
2.4 Brief description ........................................................................................................................ 2-2
2.5 Intended use .............................................................................................................................. 2-4
2.5.1 Fields of application..................................................................................................................... 2-4
2.5.2 Side effects.................................................................................................................................. 2-4
2.5.3 Contraindications......................................................................................................................... 2-4
2.6 Target group .............................................................................................................................. 2-4
2.7 Duties of the responsible organization ................................................................................... 2-4
2.8 Operator responsibility ............................................................................................................. 2-5
2.9 Disclaimer of liability................................................................................................................. 2-5
2.10 Use of consumables.................................................................................................................. 2-5
2.11 Maintenance............................................................................................................................... 2-6
2.12 Addresses .................................................................................................................................. 2-7

3 Design
3.1 Views .......................................................................................................................................... 3-1
3.1.1 Front view .................................................................................................................................... 3-1
3.1.2 Rear view..................................................................................................................................... 3-3
3.1.3 Monitor front ................................................................................................................................ 3-5
3.1.4 Monitor rear and power supply unit ............................................................................................. 3-7
3.2 User interface............................................................................................................................. 3-9
3.2.1 Blood pump (arterial) ................................................................................................................... 3-9
3.2.2 Heparin pump ............................................................................................................................ 3-10
3.2.3 Air detector ................................................................................................................................ 3-11
3.2.4 Single-Needle blood pump (optional) ........................................................................................ 3-12
3.2.5 Description of the key pad ......................................................................................................... 3-13
3.2.6 Screens ..................................................................................................................................... 3-14
3.2.7 Using the menus – examples .................................................................................................... 3-16
3.2.8 Menu description ....................................................................................................................... 3-18
3.2.9 Description of the messages in the menus................................................................................ 3-25

Fresenius Medical Care 4008 S OP-EN 4/12.10 iii


4 Operation
4.1 Preparation of the dialysis device............................................................................................ 4-1
4.1.1 Turning power on......................................................................................................................... 4-1
4.1.2 Blood pump self-test .................................................................................................................... 4-2
4.1.3 Heparin pump self-test................................................................................................................. 4-2
4.1.4 Concentrate supply...................................................................................................................... 4-2
4.1.4.1 Central Delivery System ............................................................................................... 4-3
4.1.4.2 Setting the container mixing ratio for acetate dialysis to 1+34 ..................................... 4-4
4.1.4.3 Acetate dialysis ............................................................................................................ 4-5
4.1.4.4 Bicarbonate dialysis ..................................................................................................... 4-6
4.1.4.5 bibag®........................................................................................................................... 4-6
4.1.5 T1 test.......................................................................................................................................... 4-9
4.1.5.1 General notes............................................................................................................... 4-9
4.1.5.2 Starting the program..................................................................................................... 4-9
4.1.5.3 Priming during the test ............................................................................................... 4-11
4.1.5.4 Test steps................................................................................................................... 4-14
4.1.5.5 End ............................................................................................................................. 4-15
4.1.5.6 Errors.......................................................................................................................... 4-16
4.1.5.7 Interruption ................................................................................................................. 4-18
4.1.5.8 Stop ............................................................................................................................ 4-18
4.1.6 Blood pump................................................................................................................................ 4-19
4.1.6.1 Inserting the arterial blood lines ................................................................................. 4-19
4.1.6.2 Selecting the line diameter ......................................................................................... 4-20
4.1.7 Heparin pump ............................................................................................................................ 4-21
4.1.7.1 Positioning the slide carriage ..................................................................................... 4-21
4.1.7.2 Setting the delivery rate.............................................................................................. 4-22
4.1.7.3 Setting the stop time................................................................................................... 4-23
4.1.7.4 Turning the stop time off............................................................................................. 4-24
4.1.8 Air detector ................................................................................................................................ 4-24
4.1.8.1 Inserting the venous blood lines ................................................................................. 4-24
4.1.9 Extracorporeal blood circuit ....................................................................................................... 4-25
4.1.9.1 Priming ....................................................................................................................... 4-29
4.1.9.2 Setting the blood pump rate ....................................................................................... 4-31
4.1.9.3 Delivery stops ............................................................................................................. 4-31
4.1.9.4 Interrupting the priming program ................................................................................ 4-32
4.1.9.5 Premature termination ................................................................................................ 4-32
4.1.10 Dialysate side ............................................................................................................................ 4-32
4.1.10.1 Functional checks prior to each dialysis treatment..................................................... 4-32
4.1.10.2 Adjusting the acetate / acid pump .............................................................................. 4-33
4.1.10.3 Adjusting the bicarbonate pump ................................................................................. 4-33
4.1.10.4 Setting the conductivity limits ..................................................................................... 4-34
4.1.10.5 Taking a sample ......................................................................................................... 4-35
4.1.10.6 Connecting the dialyzer .............................................................................................. 4-35
4.1.10.7 Changing the dialysate flow ....................................................................................... 4-36
4.1.10.8 Changing the dialysate temperature .......................................................................... 4-37
4.1.10.9 Rinsing the dialyzer .................................................................................................... 4-37
4.2 Treatment ................................................................................................................................. 4-38
4.2.1 Ultrafiltration............................................................................................................................... 4-38
4.2.1.1 Deleting the UF volume .............................................................................................. 4-39
4.2.1.2 Entering UF parameters ............................................................................................. 4-39
4.2.1.3 Starting ultrafiltration / timer ....................................................................................... 4-42
4.2.1.4 Stopping / interrupting uItrafiltration / timer ................................................................ 4-43
4.2.1.5 Continuing ultrafiltration / timer................................................................................... 4-43
4.2.1.6 Changing UF data ...................................................................................................... 4-43

iv Fresenius Medical Care 4008 S OP-EN 4/12.10


4.2.2 Double-Needle dialysis.............................................................................................................. 4-45
4.2.2.1 Connecting the patient ............................................................................................... 4-45
4.2.2.2 Performing the dialysis ............................................................................................... 4-46
4.2.2.3 Administering a heparin bolus .................................................................................... 4-47
4.2.3 Single-Needle Click-Clack ......................................................................................................... 4-49
4.2.3.1 Selecting the treatment mode / entering treatment data ............................................ 4-49
4.2.3.2 Changing treatment data / stopping treatment ........................................................... 4-50
4.2.4 Isolated ultrafiltration ISO UF .................................................................................................... 4-51
4.2.4.1 Selecting the treatment mode .................................................................................... 4-51
4.2.4.2 Changing ISO UF data / stopping ISO UF ................................................................. 4-52
4.2.4.3 Manually entering the sequential ultrafiltration ........................................................... 4-53
4.2.5 Sodium and UF profiles ............................................................................................................. 4-56
4.2.5.1 General notes............................................................................................................. 4-56
4.2.5.2 Entering a UF profile without sodium profile............................................................... 4-57
4.2.5.3 Entering a UF profile with sodium profile.................................................................... 4-58
4.2.5.4 Entering a sodium profile without UF profile............................................................... 4-60
4.2.5.5 Entering a sodium profile with UF profile.................................................................... 4-61
4.2.5.6 End of program .......................................................................................................... 4-63
4.2.5.7 Stopping the program................................................................................................. 4-64
4.2.6 DIASAFE® plus ......................................................................................................................... 4-64
4.2.6.1 Display during treatment ............................................................................................ 4-64
4.3 End of treatment ...................................................................................................................... 4-65
4.3.1 Double-Needle dialysis.............................................................................................................. 4-65
4.3.2 Reinfusion.................................................................................................................................. 4-66
4.3.2.1 Procedure................................................................................................................... 4-66
4.3.2.2 Repeating reinfusion .................................................................................................. 4-68
4.3.2.3 Skipping reinfusion ..................................................................................................... 4-68
4.3.2.4 Stop ............................................................................................................................ 4-69
4.3.3 Stopping the treatment .............................................................................................................. 4-70
4.3.3.1 Manually stopping the treatment ................................................................................ 4-70
4.3.3.2 Stopping treatment with reinfusion program............................................................... 4-72
4.3.4 Emptying the bibag® .................................................................................................................. 4-75
4.3.5 Emptying the dialyzer ................................................................................................................ 4-77
4.4 Special menu functions .......................................................................................................... 4-79
4.4.1 Changing the DIASAFE® plus .................................................................................................. 4-79
4.4.1.1 Criteria for the filter change ........................................................................................ 4-79
4.4.1.2 Indication of a filter change ........................................................................................ 4-79
4.4.1.3 Overriding a filter change ........................................................................................... 4-81
4.4.1.4 Performing a filter change .......................................................................................... 4-81
4.4.2 bibag® ........................................................................................................................................ 4-85
4.4.2.1 Emptying the bibag® (during the treatment)............................................................... 4-85
4.4.3 Online Clearance Monitoring ..................................................................................................... 4-89
4.4.3.1 Starting Online Clearance Monitoring ........................................................................ 4-89
4.4.3.2 Manual start of Online Clearance Monitoring ............................................................. 4-89
4.4.3.3 Automatic start of Online Clearance Monitoring......................................................... 4-90
4.4.3.4 Entering or changing the OCM parameters................................................................ 4-91
4.4.3.5 Terminating / stopping Online Clearance Monitoring ................................................. 4-92
4.4.3.6 Display of the OCM parameters ................................................................................. 4-93
4.4.3.7 OCM screen ............................................................................................................. 4-100
4.4.3.8 Conductivity limits during a measurement................................................................ 4-101
4.4.3.9 Changing the concentrate settings during a CD variation ........................................ 4-101

Fresenius Medical Care 4008 S OP-EN 4/12.10 v


5 Alarm processing
5.1 Management of alarm limits ..................................................................................................... 5-1
5.1.1 Centering the arterial / venous alarm limits ................................................................................. 5-1
5.1.2 Centering the TMP alarm limits ................................................................................................... 5-2
5.1.3 Changing the arterial / venous / TMP alarm limits ....................................................................... 5-3
5.2 Needle adjustment..................................................................................................................... 5-4
5.2.1 Start ............................................................................................................................................. 5-4
5.2.2 Stop ............................................................................................................................................. 5-5
5.3 Blood alarms .............................................................................................................................. 5-6
5.3.1 Indication of alarms...................................................................................................................... 5-6
5.3.2 Arterial pressure alarm ................................................................................................................ 5-6
5.3.3 Venous pressure alarm................................................................................................................ 5-8
5.3.4 TMP alarm ................................................................................................................................... 5-9
5.3.5 Blood leak dimness warning ...................................................................................................... 5-11
5.3.6 Blood leak alarm ........................................................................................................................ 5-11
5.3.7 Blood pump alarm...................................................................................................................... 5-12
5.3.8 Heparin pump alarm .................................................................................................................. 5-13
5.3.9 Air detector alarm ...................................................................................................................... 5-13
5.3.10 Blood pump stop alarm.............................................................................................................. 5-14
5.3.11 Blood pump stop alarm in Single-Needle mode (option) ........................................................... 5-15
5.3.12 Cycle alarm in Single-Needle Click-Clack mode ....................................................................... 5-18
5.4 Dialysate alarms ...................................................................................................................... 5-19
5.4.1 Indication of alarms.................................................................................................................... 5-19
5.4.2 Conductivity alarm ..................................................................................................................... 5-20
5.4.3 Temperature alarm .................................................................................................................... 5-20
5.4.4 Flow alarm ................................................................................................................................. 5-20
5.5 Warnings .................................................................................................................................. 5-22
5.5.1 Indication of warnings ................................................................................................................ 5-22
5.5.2 Warnings / information messages ............................................................................................. 5-22
5.6 Power failure ............................................................................................................................ 5-26
5.7 Error messages during cleaning programs .......................................................................... 5-27
5.7.1 Indication of errors ..................................................................................................................... 5-27
5.7.2 Error messages ......................................................................................................................... 5-28
5.8 Error messages after turning power on ................................................................................ 5-32
5.9 Error messages when using the download function ........................................................... 5-33

6 Cleaning / disinfection
6.1 General overview ....................................................................................................................... 6-1
6.1.1 General notes .............................................................................................................................. 6-2
6.2 External cleaning ....................................................................................................................... 6-3
6.3 Basic conditions for cleaning programs ................................................................................. 6-3
6.4 Disinfection, decalcification ..................................................................................................... 6-4
6.4.1 Start ............................................................................................................................................. 6-4
6.4.2 Sequence..................................................................................................................................... 6-5
6.4.3 Stopping the program .................................................................................................................. 6-6
6.5 Cleaning / degreasing program................................................................................................ 6-7

vi Fresenius Medical Care 4008 S OP-EN 4/12.10


6.5.1 Start ............................................................................................................................................. 6-8
6.5.2 Sequence .................................................................................................................................... 6-9
6.5.3 Stopping the program ................................................................................................................ 6-10
6.6 Hot rinse ................................................................................................................................... 6-10
6.6.1 Start ........................................................................................................................................... 6-10
6.6.2 Sequence .................................................................................................................................. 6-11
6.6.3 Stopping the program ................................................................................................................ 6-12
6.7 Rinse......................................................................................................................................... 6-13
6.7.1 Start ........................................................................................................................................... 6-13
6.7.2 Sequence .................................................................................................................................. 6-14
6.7.3 Stopping the program ................................................................................................................ 6-14
6.8 Priming during cleaning programs........................................................................................ 6-15
6.8.1 Basic conditions......................................................................................................................... 6-15
6.8.2 Starting the program.................................................................................................................. 6-16
6.8.3 Setting the blood pump rate ...................................................................................................... 6-17
6.8.4 Delivery stops ............................................................................................................................ 6-17
6.8.5 Interrupting the priming program ............................................................................................... 6-18
6.8.6 Premature termination ............................................................................................................... 6-18
6.8.7 Errors......................................................................................................................................... 6-19
6.9 Precirculation during the cleaning programs....................................................................... 6-19
6.9.1 Basic conditions......................................................................................................................... 6-19
6.9.2 Preselection............................................................................................................................... 6-20
6.9.3 Start ........................................................................................................................................... 6-20
6.9.4 Setting the blood pump rate ...................................................................................................... 6-21
6.9.5 Delivery stops ............................................................................................................................ 6-22
6.9.6 Interrupting precirculation .......................................................................................................... 6-22
6.9.7 Premature termination ............................................................................................................... 6-23

7 Functional description
7.1 Description of the procedure ................................................................................................... 7-1
7.1.1 Hydraulic flow diagram 4008 S.................................................................................................... 7-2
7.1.2 Central Delivery System (CDS) ................................................................................................... 7-5
7.1.3 Description of bicarbonate dialysis .............................................................................................. 7-6
7.1.4 Description of the variation function .......................................................................................... 7-14
7.1.5 Description of Online Clearance Monitoring (OCM) .................................................................. 7-14
7.1.5.1 OCM measurement technique ................................................................................... 7-16
7.1.5.2 Time schedule of an Online Clearance Monitoring .................................................... 7-17
7.1.5.3 Sequence of measuring cycles during treatment ....................................................... 7-18
7.1.5.4 Cyclic pressure holding test ....................................................................................... 7-18
7.1.5.5 Safety during an OCM................................................................................................ 7-19
7.1.5.6 Maintenance............................................................................................................... 7-19
7.1.5.7 Technical Safety Checks............................................................................................ 7-19
7.1.6 Description of the DIASAFE® plus ............................................................................................ 7-19
7.2 Description of the extracorporeal blood circuit ................................................................... 7-24
7.2.1 Double-Needle dialysis.............................................................................................................. 7-24
7.2.2 Single-Needle Click-Clack dialysis ............................................................................................ 7-25
7.2.3 Single-Needle dialysis (option) .................................................................................................. 7-27
7.2.4 Effective blood flow and accumulated blood volume................................................................. 7-29
7.3 Cleaning programs.................................................................................................................. 7-29
7.3.1 General information on the cleaning programs ......................................................................... 7-29

Fresenius Medical Care 4008 S OP-EN 4/12.10 vii


7.3.2 Disinfection, decalcification........................................................................................................ 7-30

8 Consumables / accessories / additional equipment


8.1 Disposables................................................................................................................................ 8-2
8.2 Consumables ............................................................................................................................. 8-3
8.3 Accessories................................................................................................................................ 8-8
8.3.1 Blood pressure cuffs / pressure tubing ........................................................................................ 8-8

9 Installation
9.1 Important information before initial start-up........................................................................... 9-1
9.1.1 Connecting the hemodialysis device ........................................................................................... 9-5
9.1.2 Inserting / filling the DIASAFE® plus............................................................................................ 9-9

10 Transport / storage
10.1 Transport .................................................................................................................................. 10-1
10.1.1 Inside buildings .......................................................................................................................... 10-1
10.1.2 Outside buildings ....................................................................................................................... 10-2
10.2 Storage ..................................................................................................................................... 10-2
10.3 Environmental compatibility and recycling .......................................................................... 10-3
10.3.1 Material list................................................................................................................................. 10-3

11 Technical Safety Checks / maintenance


11.1 Important information ............................................................................................................. 11-1

12 Specifications
12.1 Dimensions, weight and housing material............................................................................ 12-1
12.2 Electrical safety ....................................................................................................................... 12-1
12.2.1 Guidance and manufacturer’s declaration for EMC (IEC 60601-1-2:2001) ............................... 12-1
12.3 Electrical supply ...................................................................................................................... 12-4
12.4 Type label (identification of the device) ................................................................................ 12-5
12.5 Fuses ........................................................................................................................................ 12-5
12.6 Operating conditions............................................................................................................... 12-6
12.7 Storage conditions .................................................................................................................. 12-6
12.8 External connection options .................................................................................................. 12-7
12.9 Override conditions................................................................................................................. 12-7

viii Fresenius Medical Care 4008 S OP-EN 4/12.10


12.10 Operating programs ................................................................................................................ 12-8
12.11 Dialysate circuit and safety systems..................................................................................... 12-9
12.12 Extracorporeal blood circuit and safety systems .............................................................. 12-12

13 Definitions
13.1 Definitions and terms.............................................................................................................. 13-1
13.2 Abbreviations........................................................................................................................... 13-2
13.3 Symbols.................................................................................................................................... 13-3
13.4 Literature .................................................................................................................................. 13-4
13.5 Certificate ................................................................................................................................. 13-6
13.5.1 EC certificate ............................................................................................................................. 13-6

14 Options
14.1 Single-Needle dialysis............................................................................................................. 14-2
14.1.1 Preparation ................................................................................................................................ 14-2
14.1.1.1 Setting the stroke volume when using a Single-Needle blood pump ......................... 14-3
14.1.1.2 Connecting the patient ............................................................................................... 14-3
14.1.1.3 End of treatment......................................................................................................... 14-6
14.2 Option BPM (Blood Pressure Monitoring) ............................................................................ 14-8
14.2.1 To be observed before using the BPM option ........................................................................... 14-8
14.2.2 BPM menu overview.................................................................................................................. 14-8
14.2.3 Applying the blood pressure cuff ............................................................................................... 14-9
14.2.4 Checking / setting the inflation pressure / alarm limits ............................................................ 14-10
14.2.5 Starting the blood pressure measurement .............................................................................. 14-10
14.2.5.1 Single measurement ................................................................................................ 14-11
14.2.5.2 Interval (long-term interval measurement) ............................................................... 14-11
14.2.5.3 Quick (short-term interval measurement)................................................................. 14-12
14.2.6 Terminating / interrupting the blood pressure measurement................................................... 14-13
14.2.7 Displaying graphics and blood pressure history ...................................................................... 14-13
14.2.8 Specifications / general notes................................................................................................. 14-14
14.2.9 Description of the BPM............................................................................................................ 14-16
14.2.10 BPM error messages.............................................................................................................. 14-18
14.3 Transferring treatment parameters (download) (Network option) .................................... 14-20
14.3.1 Description............................................................................................................................... 14-20
14.3.2 Basic conditions....................................................................................................................... 14-20
14.3.3 Important notes........................................................................................................................ 14-21
14.3.4 Sequence ................................................................................................................................ 14-21
14.3.5 Stop ......................................................................................................................................... 14-23

15 Appendix
15.1 Chapter without content ......................................................................................................... 15-1

Fresenius Medical Care 4008 S OP-EN 4/12.10 ix


x Fresenius Medical Care 4008 S OP-EN 4/12.10
Chapter 1: Index

1 Index
A Blood pump stop alarm in Single- Dialyzers 8-2
Needle mode (option) 5-15 DIASAFE® plus, service life 12-11
Abbreviations 13-2
BPM 14-8, 14-16 Dimensions 12-1
Acetate dialysis 4-5
BPM interval (long-term interval Disclaimer of liability 2-5
Addresses 2-7 measurement) 14-16
Disinfectants 8-3
Air detector 3-11 BPM pressure connection 14-15
Disinfection 6-1, 8-4
Air detector alarm 5-13 BPM pressure tubing 8-8, 14-8
Disinfection connector 3-4
Alarm output (external alarm) 12-7 BPM restrictions 14-17
Disinfection, decalcification 6-4
Alarm override 12-8 BPM, Quick (short-term interval
Download 14-20
Alarm processing 5-1 measurement) 14-17
Downtime, temporary 12-6
Alarm, audible alarm 12-13 BPM, single measurement 14-16
Drain 3-4
Alarm, audible alarm suppression Brake 3-2
12-7 Duties of the responsible
Brake, locking 10-1
organization 2-4
Appendix 14-1, 15-1 Bubble catcher 4-24, 4-26, 4-31,
Arterial blood lines, inserting 4-19 4-46
Arterial pressure 13-1 E
Arterial pressure alarm 5-6 C Electrical installation 9-1
Aseptic technique 4-25 Electrical safety 12-1
Central Delivery System 3-4, 4-3,
7-5, 9-3 EMC 12-1
B Cleaning / degreasing program 6-7 Emptying the dialyzer 4-77
Cleaning / disinfection 6-1 Environmental compatibility and
Battery 12-4, 12-6
recycling 10-3
bibag® 4-6 Cleaning programs, basic
conditions 6-3 Error messages during cleaning
bibag®, emptying 4-75 programs 5-27
Bicarbonate dialysis 4-6 Connect the Single-Needle
pressure transducer. 14-2 External cleaning 6-3
Bicarbonate dialysis with a bibag® External connection options 12-7
Consumables / accessories /
4-7
additional equipment 8-1 Extracorporeal blood circuit
Blood alarm 13-1 module 3-2
Contraindications 2-4
Blood alarms 5-6
Blood leak alarm 5-11
D F
Blood leak dimness warning 5-11
Decalcification, agents 8-5 Fields of application 2-4
Blood pressure 14-15
Definitions and terms 13-1 Functional checks prior to each
Blood pressure cuff 3-2, 8-8, dialysis treatment 4-32
14-10, 14-15 Degreasing program 6-7
Functional description 7-1
Blood pressure cuff holder 14-15 Deleting the UF volume 4-39
Blood pressure cuff, applying 14-9 Description of screen colors 3-15
Blood pressure cuffs 8-8 Design 3-1 H
Blood pressure measurement, Dialysate flow, changing 4-36 Heparin pump 3-10, 4-21
start 14-10 Dialysate inlet tube 3-4 Heparin pump, positioning of slide
Blood pressure measurement, carriage 4-21
Dialysate outlet tube 3-3
terminating 14-13 Heparin pump, setting the delivery
Dialysate temperature, changing
Blood pressure measuring 14-8 rate 4-22
4-37
Blood pump (arterial) 3-9 Heparin pump, setting the stop
Dialysis dose Kt/V 7-15
time 4-23
Blood pump alarm 5-12 Dialyzer, connecting 4-35

Fresenius Medical Care 4008 S OP-EN 4/12.10 1-1


Chapter 1: Index

Heparin pump, stop time 7-25 Priming during cleaning programs U


Heparin pump, turning stop time 6-15
Ultrafiltration 4-38
off 4-24 Pulse 14-15
User interface 3-9
Hot rinse 6-10
Using the menus 3-16
How to use the Operating Q
Instructions 2-1
Quick (short-term interval
measurement) 14-12
V
I Venous blood lines, inserting 4-24
Venous line clamp 3-11, 4-25
Important information 2-1 R
Indicator for disinfectants 8-6 Venous pressure measuring line
Recommissioning 11-1 4-25
Inflation pressure 14-10 Residual disinfectant, checking Vent tubing 3-4
Initial start-up, important 6-5
information 9-1 Rinse 6-13
Installation 9-1 W
Intended use 2-4 Water connector (permeate) 3-4
S
Interval (long-term interval Weight 12-1
measurement) 14-11 Sample collection 4-35
Interval mode, stopping (blood Sampling valve 3-3
pressure) 14-12 Screens 3-14
Service life, DIASAFE® plus 12-11
K Side effects 2-4
Significance of the note 2-2
Key pad 3-13
Significance of the warning 2-2
Kt/V 7-15
Single measurement (blood
pressure) 14-11
M Single-Needle blood pump
Manufacturer 2-7 (optional) 3-12
Mixing ratio 4-3 Stop time of heparin pump 7-25
Monitor front 3-5 Storage 10-2
Symbols 13-3
N
Network option 14-20 T
Target group 2-4
O Technical Safety Checks /
maintenance 11-1
Operating conditions /
specifications 12-6 Temperature alarm 5-20
Operation 4-1 Transport / storage 10-1
Operator responsibility 2-5 Transport inside buildings 10-1
Transport outside buildings 10-2
Treatment 4-38
P
Treatment parameters, transfer
Positioning the slide carriage 4-21 14-20
Power failure 5-26 Treatment, items to be observed
Power supply unit 3-4 before and during treatment 4-25
Precirculation during the cleaning
programs 6-19
Pressure tubing 14-15

1-2 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 2: Important information

2 Important information

2.1 How to use the Operating Instructions

Identification The document can be identified by the following information on the title
page and on the labels:
– Software version of the device
– 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 1/01.09, for example, refers to: 1. edition,
January 2009.

Illustrations The illustrations used in the documents (e.g. screens, photos, etc.) may
differ from the original if this does not have any influence on the
function.

Marking in the illustrations


Ring around an LED / indicator:
LED / indicator is illuminated.

Rays around an LED / indicator:


LED / indicator is flashing.

Importance of the The Operating Instructions are part of the accompanying documents
instructions and an essential part of the hemodialysis device. They include
information necessary for the use of the 4008 S device. Before the
responsible organization can begin to operate the device, the individual
responsible for the operation must have been instructed by the
manufacturer on how to use the device and must be thoroughly familiar
with the contents of the Operating Instructions.
The device may only be operated by individuals who have been
instructed on the proper operation and handling of the device.
The Operating Instructions must be carefully studied before attempting
to operate the device.
The Brief Operating Instructions are intended as a reference only and
do not replace the Operating Instructions manual with which the
operator must be fully familiar.

Fresenius Medical Care 4008 S OP-EN 4/12.10 2-1


Chapter 2: Important information

2.2 Significance of the warning

Caution
Advises the operator against certain procedures or actions that could
cause damage to the equipment or may have adverse effects on
individuals.

2.3 Significance of the note

Note
Informs the operator that failure to follow the steps as specified may
result in the specific function not being executed correctly, not being
executed at all, or not producing the desired effect.

2.4 Brief description

The 4008 S hemodialysis device allows dialysis treatments without any


additional equipment. The device operates and monitors the dialysate
circuit and the extracorporeal blood circuit.
The required treatment parameters can be entered via various menus
provided for programming and displayed on a high-resolution LC
display (liquid crystal). The current treatment data are shown on the
display.
In the dialysate circuit, purified water is mixed with hemodialysis
concentrate, heated, degassed and delivered to the dialyzer. Inflowing
and outflowing volumes are balanced volumetrically. The pressure at
the dialyzer is adjusted depending on the ultrafiltration rate selected and
the type of dialyzer used.
With the DIASAFE® plus function hemodialysis treatments can be
performed with high purity dialysate solution. The DIASAFE® plus
function basically consists of one filter stage. For the entire time of its
use the filter is an integral part of the hemodialysis device and is rinsed
and disinfected in conjunction with the device. The integrity of the filter
is tested by means of a pressure holding test. The pressure holding test
is integrated in the T1 test of the hemodialysis device. The filter can be
used for a maximum period of 12 weeks. Should the filter fail to pass the
filter test, it must be replaced at an earlier date. For the use of this
option, the quality of the water and the dialysate must comply with the
applicable standards (see chapter 9, page 9-1).

2-2 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 2: Important information

In the extracorporeal blood circuit, the blood is continuously heparinized


and passes through the dialyzer. An air detector prevents infusion of air.
Any dangerous loss of blood is prevented by a blood leak detector and
by monitoring of the venous return pressure. The arterial pressure
monitoring unit detects any changes of the flow via the needle in the
vessel.
The hemodialysis device is designed for both acetate dialysis and
bicarbonate dialysis.
The mixing ratio of concentrate to purified water can be programmed
(default setting 1+34, selection of other mixing ratios is possible).
Depending on the concentrate used, the Na+ concentration can be
readjusted within a range of 125 mmol/l to 150 mmol/l.
The bicarbonate concentration can be readjusted within a range of
±8 mmol/l.
With the bibag® function the bicarbonate solution is produced from a
bag (sodium hydrogen carbonate powder, NaHCO3). The powder is
diluted in the device to obtain ready-to-use bicarbonate.
Na+ and UF profiles can be programmed using the built-in variation
function.
It is possible to perform ultrafiltration without dialysate flow (sequential
dialysis/isolated ultrafiltration, ISO-UF).
The dialysate flow can be adjusted (300 ml/min, 500 ml/min and 800
ml/min).
The basic version of the hemodialysis device is designed for Double-
Needle dialysis.
Freely selectable programs are available for cleaning and disinfecting
the device.
The hemodialysis device is equipped with all safety systems required
for proper function and patient safety EN 60601-1 (IEC 601-1).
The automatic test of the safety systems (T1 test) must be performed
prior to each dialysis treatment. This test also checks the integrity of the
closed system (pressure holding test PHT).
In the following cases, the hemodialysis device will request the operator
to perform the T1 test:
– After a start with external power supply (not power failure)
– After one of the cleaning programs
For additional safety, cyclic pressure holding tests (CPHT) are also
performed during the dialysis treatment to detect possible leakages in
the closed system.
The CPHT is performed automatically every 12.5 min. For the CPHT
the dialysis device is switched for a few seconds into bypass and
ultrafiltration is stopped. Balancing is not affected by these CPHTs, but
the effective dialysis time will be reduced by approx. 2 min per hour of
treatment.
The 4008 S hemodialysis device reflects the latest state of technology
and complies with the regulations of EN 60601-1 (IEC 601-1).
It is classified as class II b (MDD) equipment.

Fresenius Medical Care 4008 S OP-EN 4/12.10 2-3


Chapter 2: Important information

2.5 Intended use

2.5.1 Fields of application

The 4008 S hemodialysis device is designed for performing chronic and


acute hemodialysis. It can be used in home dialysis, limited care centers
and clinical hemodialysis.
The Online Clearance Monitoring (OCM) function determines the
average effective Clearance (K) for urea, the dialysis dose Kt/V and the
plasma-Na concentration during the dialysis treatment.

2.5.2 Side effects

Dialysis therapies occasionally cause hypotension, nausea, vomiting


and cramping in some patients. Please take note of the package inserts
enclosed with the hemodialysis concentrates, dialyzers, etc.

2.5.3 Contraindications

– Hyperkalemia (for potassium-containing hemodialysis concentrates


only)
– Hypokalemia (for potassium-free hemodialysis concentrates only)
– Uncontrollable coagulation anomalies
A different method of extracorporeal treatment may be indicated in
hemodynamically unstable patients.

2.6 Target group

The device may only be installed, operated and used by individuals with
the appropriate training, knowledge and experience.
Assembly, extensions, adjustments, modifications or repairs may only
be carried out by the manufacturer or persons authorized by him.

2.7 Duties of the responsible organization

The responsible organization assumes the following responsibilities:


– Compliance with the national or local installation, operation, use and
maintenance regulations
– Compliance with the accident prevention regulations
– Correct and safe condition of the device
– Permanent availability of the Operating Instructions

2-4 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 2: Important information

2.8 Operator responsibility

If the hemodialysis device shows signs of mechanical damage


preventing safe operation, stop using the device. Applied parts that are
damaged must be replaced.
When entering parameters, the following must be observed:
The parameters entered must be verified by the operator, i. e. the
operator must check, if the values entered are correct. Should the
desired value deviate from the parameters displayed, the setting must
be corrected before activating the function.
The actual values displayed must be compared with the desired values
specified.

2.9 Disclaimer of liability

Caution
The device has been approved for use with specific consumables and
accessories (see chapter 8, page 8-1).
Should the responsible organization wish to use other consumables
and accessories than those listed in the above-mentioned chapter, the
responsibility to ensure the correct function of the device 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 device resulting from the use of non-approved or unsuitable
consumables or accessories.

2.10 Use of consumables

The symbols printed on the packaging of the consumables have to be


observed (see chapter 13.3, page 13-3).
When using consumables, it is important to take note of the following
symbols:
Do not re-use

2
Use by

Fresenius Medical Care 4008 S OP-EN 4/12.10 2-5


Chapter 2: Important information

The consumables may only be used if the packaging and the respective
consumable including the protective caps used are not damaged. The
protective caps must not have fallen off.
The plastics used for the consumables may not be compatible with
components of drugs or disinfectants. If they are planned to be used,
the compatibility of the consumables' components must be ensured
before the treatment. If connectors made of polycarbonate are for
example exposed to aqueous solutions having a pH value > 10 or to
aliphatic solutions, this will cause tension cracks.

2.11 Maintenance

Perform the maintenance procedures specified in the Service Manual.


The Technical Safety Checks (TSC) are included in the maintenance
intervals.

2-6 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 2: Important information

2.12 Addresses

Please address any inquiries to:

Manufacturer Fresenius Medical Care AG & Co. KGaA


61346 Bad Homburg
Germany
Phone: +49 (0)6172 609-0
www.fmc-ag.com

International Fresenius Medical Care


service Deutschland GmbH
Service Support International
Hafenstraße 9
97424 Schweinfurt
Germany
Phone: +49 (0)9721 678-333 (hotline)
Fax: +49 (0)9721 678-130

Local
service

Fresenius Medical Care 4008 S OP-EN 4/12.10 2-7


Chapter 2: Important information

2-8 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 3: Design

3 Design

3.1 Views

3.1.1 Front view

8
1

2 7

Fresenius Medical Care 4008 S OP-EN 4/12.10 3-1


Chapter 3: Design

1 Monitor
2 Blood pressure cuff
3 Extracorporeal blood circuit module
4 Concentrate connectors
5 Brake
6 Shunt interlock for the dialyzer connecting lines
7 IV pole
8 Status indicator

3-2 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 3: Design

3.1.2 Rear view

13

2
3

12

5 11

6 10
7 9

1 Monitor (rear view)


2 Sampling valve
3 Bracket for the dialyzer connection lines
4 Dialysate outlet tube

Fresenius Medical Care 4008 S OP-EN 4/12.10 3-3


Chapter 3: Design

5 Dialysate inlet tube


6 Disinfection connector
7 Filter
8 CDS (red) option
9 Drain
10 Water connector (permeate) or connector for water inlet filter
11 DIASAFE® plus
12 Vent tubing
13 Power supply unit

3-4 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 3: Design

3.1.3 Monitor front

1a 8a 9a
1b
10a 11a 12a
2a
2b

3a
3b

10b 11b 12b 18f


4a
4b 13a
14a 16a
5a
5b
14b 16b
6a 13b
6b 17a

7a 15a 16c 17b


7b

18a 18b 18c 18d 18e

 Monitor front description

The complex functions of the controls on the monitor are illustrated and
explained in the description of the operation of the device.

Function keys (pos. 1–7) 1a On/Off key


1b On/Off LED
2a Cleaning key
2b Cleaning LED
3a SN key
3b SN LED
4a Test key
4b Test LED
5a Prime key
5b Prime LED
6a Start/Reset key
6b Start/Reset LED
7a Mute key

Fresenius Medical Care 4008 S OP-EN 4/12.10 3-5


Chapter 3: Design

7b Mute LED

Blood monitor (pos. 8–12) 8a Air Detector alarm indicator


9a Blood Leak alarm indicator
10a Arterial Pressure alarm indicator
10b Arterial Pressure measurement value indicator
11a Venous Pressure alarm indicator
11b Venous Pressure measurement value indicator
12a TMP alarm indicator
12b TMP measurement value indicator

Dialysate monitor 13a Conductivity alarm indicator


(pos. 13–15)
13b Conductivity measurement value indicator
14a Flow LED
The LED is illuminated: The flow is on
The LED is not illuminated: The flow is off
The LED is flashing: Bypass operation
14b Flow ON/OFF key
15a Dialysate Menu key

Ultrafiltration section 16a UF LED


(pos. 16)
16b UF ON/OFF key
16c UF Menu key

BPM keys (pos. 17) 17a BPM Start/Stop key


17b BPM Menu key

Screen/screen data entry 18a Screen data entry keys:


(pos. 18) Keys 0–9
Keys +/–
18b C key
18c Conf key
18d Arrow keys
18e Esc key
18f Screen

 Status indicator description

Possible conditions:
– Status indicator shows green light (operation)
– Status indicator shows yellow light (warning/info)
– Status indicator shows red light (alarm)

3-6 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 3: Design

3.1.4 Monitor rear and power supply unit

Caution
Apart from the options mentioned, additional equipment should only be
connected to the ports on the rear of the monitor if the resulting overall
system complies with the requirements of EN 60601-1-1 (IEC 601-1-1),
or if their applicability with regard to technical safety has been proven
by a certificate issued by a testing agency authorized to test the ready-
for-use system.

1 2 3 4 5 6 7 8 9 10 11 12 13

17

16
15

14

1 Fan
2 Service switch
3 Audible alarm volume control
4 no longer used
5 Network port (option)
6 Input/output port (for external equipment)

Fresenius Medical Care 4008 S OP-EN 4/12.10 3-7


Chapter 3: Design

7 Screen / service PC socket


8 Hour meter
9 Remote control port (additional equipment)
10 ALARM IN port (for connection of an external pushbutton switch.
This button can be used to initiate a system stop.)
11 Loudspeaker for audible alarm
12 ALARM OUT port (for connection of an external alarm indicator,
staff call)
13 Symbol: Caution: Consult accompanying documents.
14 Power cable with locking screw (supplies the hemodialysis device
with line voltage)
15 Power switch (main switch)
16 Power supply unit (voltage supply for the hemodialysis device)
17 Network port (option)

3-8 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 3: Design

3.2 User interface

3.2.1 Blood pump (arterial)

2 1

3
4 11
5 10

1 Key pad of the arterial blood pump (highlighted in red)


2 Display (indicates the delivery rate, the line diameter, the SN
stroke volume, or an error code)
3 Alarm (red) LED
4 Operation (green) LED
5 Start/Stop key (for turning the blood pump on or off)
6 Pressure connector (Luer-lock connector of the arterial pressure
measuring line), highlighted in red
7 Rotor (delivers the patient’s blood by means of the rollers and the
lines installed. The rotor can be removed for cleaning.)
8 Clamping piece (holds the installed line segment securely in place)
9 Sensor (blood pump door open or closed)
10  key (for reducing the delivery rate or the value of the line
diameter)
11  key (for increasing the delivery rate or the value of the line
diameter)

Fresenius Medical Care 4008 S OP-EN 4/12.10 3-9


Chapter 3: Design

3.2.2 Heparin pump

2 12
3 11
4 10
5 9
8

1 Display (displays the delivery rate, the stop time, the bolus amount
or an error code)
2 Alarm (red) LED
3 Operation (green) LED
4 Bolus key
5 Start/Stop key (for turning the heparin pump on or off)
6 Slide carriage (moves the syringe plunger)
7 Syringe holder
8  key (for reducing the delivery rate or the stop time and for
moving the slide carriage down)
9 Clock key (for setting the stop time)
10 Stop time (green) LED
11 Rate key (for setting the delivery rate)
12  key (for increasing the delivery rate or the stop time and for
moving the slide carriage up)

3-10 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 3: Design

3.2.3 Air detector

1 Keys (for raising () and lowering () the fluid level in the venous
bubble catcher)
2 Venous pressure connector (Luer-lock connector of the venous
pressure measuring line)
3 Holder for the venous bubble catcher with ultrasonic sensors
4 Venous line clamp
5 Optical detector

Fresenius Medical Care 4008 S OP-EN 4/12.10 3-11


Chapter 3: Design

3.2.4 Single-Needle blood pump (optional)

1 2 3

12 4
11 5

8
9
10

1 Alarm (red) LED


2 Display (indicates the delivery rate, the line diameter, the SN
stroke volume or an error code)
3 Key pad of the Single-Needle blood pump (highlighted in white)
4  key (for increasing the delivery rate, the SN stroke volume or
the value of the line diameter)
5  key (for reducing the delivery rate, the SN stroke volume or the
value of the line diameter)
6 Pressure connector (Luer-lock connector of the SN pressure
measuring line), highlighted in white
7 Rotor (delivers the patient’s blood by means of the rollers and the
lines installed. The rotor can be removed for cleaning.)
8 Blood pump door
9 Sensor (blood pump door open or closed)
10 Clamping piece (holds the installed line segment securely in place)
11 Start/Stop key (for turning the blood pump on or off)
12 Operation (green) LED

3-12 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 3: Design

3.2.5 Description of the key pad

1 2 3 4 5 6

1 Entering data (numerical values).


2 Changing data (numerical values) or functions.
3 Resetting data (numerical values) to 0 or to a preset value.
4 Selecting a menu or the fields to be changed.
5 After all data of a menu have been changed, the changes are
saved by pressing the Conf key once.
6 Exiting a menu without saving the data.

Fresenius Medical Care 4008 S OP-EN 4/12.10 3-13


Chapter 3: Design

3.2.6 Screens

 Description of the Ultrafiltration menu (example)

1 2

1 Status display
2 Text field
3 Menu field
4 Menu bar (shows the menus which can be selected with the arrow
keys)

3-14 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 3: Design

 Description of screen colors

The currently selected menu and the text bar are always displayed as
follows: White characters on blue background
The following colors are used in the menu field and the menu bar:

Background Characters Data (numerical values), function


or menu

blue white can be selected

green black can be changed

grey white can not be selected or changed

black white can not be selected or changed

Fresenius Medical Care 4008 S OP-EN 4/12.10 3-15


Chapter 3: Design

3.2.7 Using the menus – examples

 Example 1: Changing the venous alarm window

Dialysis menu
Use the Arrow keys to select the Alarm
limits menu.

Press the Conf key.

Use the Arrow keys to select Position of the


venous alarm window.

Use the +/– keys to change the venous alarm


window.

Press the Conf key. The screen returns to the


Dialysis menu.

3-16 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 3: Design

 Example 2: Changing the dialysate flow

Press the Dialysate Menu key.

The Dialysate menu is displayed.


Use the Arrow keys to select Flow.

Use the +/– keys to set the desired dialysate


flow.

Press the Conf key. The screen returns to the


Dialysis menu.

Fresenius Medical Care 4008 S OP-EN 4/12.10 3-17


Chapter 3: Design

3.2.8 Menu description

 Power-up screen

Shows the device type and, in the upper right


text field, the software version.

 T1 test

The following definitions are valid for the test sequence:

Test step Background Characters OK Error

Prior to the blue white


test

during the green black


test

successfully blue white 


completed

failed red white 

skipped red white 

Moreover the test step currently in progress is shown in the text field.

3-18 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 3: Design

 Dialysis menu

The Dialysis menu shows the current status of the device during
dialysis.
Moreover it provides the option to graphically display parameters of the
treatment in progress or of recorded treatment data.
If other menus are selected and no key is pressed for approx.
30 seconds, the screen automatically returns to the Dialysis menu
(exception: UF menu).

If only a UF profile is selected, the graphical


1
Profiles display will show:
2 1 The selected desired sodium value
(black dashed line)
3
2 The actual sodium (blue)
4 3 The UF volume already removed
(yellow)
4 The desired UF rate (black)

1 If only a sodium profile is selected, the


graphical Profiles display will show:
2
1 The desired sodium (black)
3
2 The actual sodium (blue)

4 3 The UF volume already removed


(yellow)
4 The selected desired sodium value
(black dashed line)

Fresenius Medical Care 4008 S OP-EN 4/12.10 3-19


Chapter 3: Design

If both a UF and sodium profile are selected


1 the graphical Profiles display will show:
2 1 The selected desired sodium value
3 (black dashed line)
4 2 The actual sodium (blue)

5 3 The UF volume already removed


(yellow)
6 4 The desired UF rate (black)
Except for Single-Needle mode, the graphical
display will always show the pressure
recording:
5 Arterial pressure (red)
6 Venous pressure (blue)
The data will be erased if:
– A power failure occurs without battery
backup
– Treatment parameters are deleted
– A cleaning program is selected

Graphical presentation of blood pressure


(optional):
1 Systolic blood pressure in mmHg (red)
2 Diastolic blood pressure in mmHg
(blue)
1

3-20 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 3: Design

Graphical presentation of the OCM data

Graphical presentation of the OCM


parameters

 Dialysate menu

The Dialysate menu displays the dialysate


parameters.
With the exception of the dilution (mixing
ratio), the values for all other parameters
displayed can be entered or changed.
In the Base Na+ field, the value indicated on
the container has to be entered.
Moreover the Empty BIBAG function can be
selected.

Fresenius Medical Care 4008 S OP-EN 4/12.10 3-21


Chapter 3: Design

 Ultrafiltration menu

The Ultrafiltration menu displays the


ultrafiltration parameters.
With the exception of the Max. Rate, UF
Volume and ISO Volume, the values of all
other parameters displayed can be entered or
changed.

 Treatment mode

This menu permits selection of the following


treatment mode:
– SN click clack
If "Ven. window position ON" is activated in
the SETUP:
The minimal value that can be set for the
lower venous alarm limit can be changed.
Use the arrow keys to select Lower Limit in
the Venous window position window.
Use the +/– keys to set the lower venous
alarm limit to +20 mmHg (default setting) or
to -60 mmHg.
Use the Conf key to save.

 Alarm limits menu

The Alarm limits menu permits selection


and deselection of the Reinfusion and the
Needle Adj.Pgm function.
This menu also includes the fields for
changing the position and size of the arterial,
the venous and the TMP alarm window.

3-22 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 3: Design

 System parameters

The following settings can be defined in the


System parameters menu:
– Delete treatment parameters
– Brightness
– Auto-On Program:
Auto-On can be programmed for cleaning
programs or the start of the T1 test. The
power-up time can be set individually for
each day of the week.
– System Time:
for setting the current date and time

Setting the system parameters:


Use the Arrow keys to select the desired
parameter.
– Delete treatment parameters:
Use the +/– keys to set Yes.
– Brightness:
Can be changed by means of the +/–
keys.
– Auto-On Program:
Use the keys 0–9 or the +/– keys to set
the desired program and time.
– Use the keys 0–9 or the +/–keys to set the
desired date and time.
Use the Conf key to save.

Auto-On program Following completion of the last disinfection of the device of the day it is
possible to connect a bibag® (72 hours is the maximum time allowed
prior to the treatment).
If you wish to use this possibility, the following actions must be
performed.
Requirements:
– Pre-program the T1 test under Auto On.
(Observe the time programming of the osmosis unit.)
– CDS for acid connected.

Caution
After removal of the foil, immediately connect the bibag® using aseptic
technique. Then close the bicarbonate flap.

Fresenius Medical Care 4008 S OP-EN 4/12.10 3-23


Chapter 3: Design

 Dialysis presentation

In the Dialysis representation menu several


diagrams can be selected. It is for example
possible to record the arterial/venous
pressure and blood pressure values in the
Dialysis menu. If the same diagram has
been selected for both display fields or if no
diagram has been selected for one field by
pressing 0, the diagram selected will be
displayed in double size. (Factory setting:
Upper Selection 1, Lower Selection 2)
The cumulated blood volume and the
effective dialysis time are shown in the
Dialysis data field.

Selecting the diagrams:


Use the Arrow keys to select Upper
Selection or Lower Selection.
Use the keys 0–9 or the +/– keys to set the
desired diagram.
Use the Conf key to save.

Presentation in the Dialysis menu, e.g.


Profiles and BPM

Presentation in the Dialysis menu, e.g.


Profiles in large size

3-24 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 3: Design

 Cleaning menu

The Cleaning menu displays the available


cleaning programs. The desired cleaning
program can be selected and started via the
menu.
The Cleaning menu also displays:
– The Filter change function.
– The Last disinfection function. Here the
date, the time and the program of the last
disinfection that was fully completed
(arrow) are displayed.

 Cleaning process menu (e.g. Hot disinfection)

Each cleaning program has its own process


menu. This menu shows the Time Left and
the Temperature. Moreover the cleaning
process is displayed graphically.
Yellow area: Disinfectantconcentration
Red-blue area: Temperature curve

3.2.9 Description of the messages in the menus

 Alarm

The possible alarm messages are listed in


chapter 5, Alarm processing.

Fresenius Medical Care 4008 S OP-EN 4/12.10 3-25


Chapter 3: Design

Note
To enter values while messages are displayed, the message can
temporarily be cleared from the screen by pressing the Arrow keys.

 Warning

The possible warnings are listed in chapter 5,


Alarm processing.

Note
To enter values while messages are displayed, the message can
temporarily be cleared from the screen by pressing the Arrow keys.

 Info

The possible info messages are listed in


chapter 5.

3-26 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

4 Operation

4.1 Preparation of the dialysis device

4.1.1 Turning power on

Turn on the water supply.

Press the On/Off key.


Turn the hemodialysis device on!

On/Off LED is illuminated.

The display shows the device type and the


software version installed.
(Warning / info).
Internal RAM test
CRC test
24V safety shutdown test
(watchdog)
SCANNING CAN-BUS

Info message
Last disinfection:
Only if "Auto OFF after Auto ON" is activated
21.05.03 16:25 in the SETUP menu:
( Continue with [Conf] key )
Info message, if the last disinfection was
more than 72 hours ago. The device must be
disinfected.
Use the Conf key to confirm.
The Cleaning menu can directly be
selected by pressing the Cleaning key.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-1


Chapter 4: Operation

4.1.2 Blood pump self-test

Rate: ml/h (Ø:ml) The LED segments,


Alarm (red) LED and
Start LED Operation (green)
Stop
will light for 1 second.
The line diameter will be displayed for
approx. 2 seconds.
The delivery rate will be displayed.

4.1.3 Heparin pump self-test

Rate: ml/h (Bolus:ml) The LED segments,


( :h.min)
Rate Alarm (red) LED,
Bolus Start Operation (green) LED and
Stop
LED Stop time (green)
will light for 1 second.
The syringe size will be displayed.
The delivery rate will be displayed.

4.1.4 Concentrate supply

Caution
Concentrate:
The concentrate displayed on the screen must comply with the
specifications mentioned on the acid or the acetate container or on the
bag. This also applies to the concentrate composition in CDS operation.
Concentrate packages:
– Assure that the packages used contain sufficient concentrate to
complete the treatment.
– Use only the dedicated coded containers or the bibag® for
bicarbonate dialysis.
Bicarbonate dry concentrate bibag®:
Only the bibag® manufactured by Fresenius Medical Care may be used.
The bibag® must only be used for one treatment.
Only use the bibag® in combination with acid bicarbonate hemodialysis
concentrate according to the prescribed dilution. Other mixing ratios
may lead to a hazard for the patient.
Acid and basic bicarbonate hemodialysis concentrate have to be diluted
immediately prior to application only. The bag's content must be used
up within 12 hours after dilution. Discard residual volumes. The powder
is non-pyrogenic.

4-2 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

4.1.4.1 Central Delivery System

 General notes

Note
When using CDS, connect the concentrate suction tubes to match the
selected type of concentrate delivery (SETUP).
Default setting in SETUP: CDS off.

Press the Dialysate Menu key to check the


setting.

Note
The predefined mixing ratio in the SETUP will be displayed in the
Dilution field.
– Grey field, white characters:
CDS mixing ratio; the value cannot be changed
– Black field, white characters:
Container mixing ratio; the value cannot be changed
– Blue field, white characters:
Container mixing ratio; the value can be changed, depending on the
SETUP specification
The CDS can be deactivated if desired, see following description.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-3


Chapter 4: Operation

 Turning the CDS off

Press the Dialysate Menu key.

Use the Arrow keys to select the CDS field.


Use the +/– keys to set CDS to OFF.

Press the Conf key.

4.1.4.2 Setting the container mixing ratio for acetate dialysis to 1+34

Press the Dialysate Menu key.

4-4 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Note
If acetate dialysis (mixing ratio 1+34) is desired but a different mixing
ratio has been set, the basic conditions have to be checked:
– Acetate connected
– Bicarbonate suction tube in rinse chamber
– Central bicarbonate delivery off
– bibag® not connected

The mixing ratio defined in the SETUP will be


displayed.
Use the Arrow keys to select the Dilution
field.
Use the +/– keys to set the mixing ratio to
1+34.
Press the Conf key to confirm the mixing
ratio.

Info message
Check Concentrate!
Info message
(Select with [Conf] key) Press the Conf key to confirm the safety
prompt.

4.1.4.3 Acetate dialysis

Place the combined concentrate suction tube


for acid and acetate (red) into the acid
container.
Leave the bicarbonate suction tube (blue) in
the rinse port or place it in the rinse port if it is
not already there.
Close the flap.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-5


Chapter 4: Operation

4.1.4.4 Bicarbonate dialysis

Place the combined concentrate suction tube


for acid and acetate (red) into the acid
container.
Place the bicarbonate suction tube (blue) in
the bicarbonate container.
Close the flap.

Caution
Make sure that the containers contain sufficient concentrate and
bicarbonate to complete the treatment.

4.1.4.5 bibag®

 General notes

If bibag® is not used, close the flap until it


clicks into place.

4-6 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Note
During treatment with the bibag®, the bicarbonate suction tube must be
inserted into the rinse port.
Removing the suction tube may cause a rinse chamber overflow.

Note
The bibag® will be filled when the bibag® is connected and the
bicarbonate suction tube is in the rinse port.

 Bicarbonate dialysis with bibag®

Place the combined concentrate suction tube


for acid into the acid container.
Close the flap.

Lift the latch up and open the bibag® flap.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-7


Chapter 4: Operation

Remove the foil from the bibag®.

Connect the bibag®. Close the bibag® flap.

After the bibag® has been connected, an


automatic program will be started (lasting
approx.35 seconds).
This program will first remove all air from the
bibag® and will then fill the bag with water.

4-8 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

4.1.5 T1 test

4.1.5.1 General notes

In the following cases, the hemodialysis device will request the operator
to perform the T1 test:
– After a start with external power supply (not power failure)
– After one of the cleaning programs.
The T1 test can be performed with or without previously installing the
tubing system. If the tubing system was filled during the cleaning
program, the dialyzer must be deaerated before starting the T1 test.
This is done by briefly opening and then closing the upper screw cap of
the dialyzer.
Depending on the setting defined in the SETUP, the T1 test will be
started automatically when turning the power on or it must be started
manually by pressing the Test key.
DIASAFE® plus :
The filter test is integrated in the T1 test.
Start conditions:
– The dialysate connectors (red/blue) are in the shunt interlock.
– The shunt interlock is closed.
– The optical detector in the air detector module senses light.
– The concentrate suction tubes are in the appropriate container or, for
use with CDS, are properly connected depending on the type of
supply.

4.1.5.2 Starting the program

 Automatic

The Test LED is flashing.


Internal tests.

Status indicator light turns yellow


(warning/info).

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-9


Chapter 4: Operation

T1 test starts automatically.


The Test LED is illuminated.
If one of the starting conditions is not
fulfilled, an audible alarm will be
sounded. Use the Test key or the Mute
key to acknowledge the audible alarm.
Make sure all starting conditions are
fulfilled. Then press the Test key to start
the test.

Note
To prevent an automatic start of the test proceed as follows:
– Open the shunt interlock flap.
– Turn the hemodialysis device on.
– Start the T1 test.
– Close the shunt interlock flap.

 Manual

The Test LED is flashing.


If the Test LED is not flashing, one of the
conditions for the test to start is not
fulfilled.

Status indicator light turns yellow


(warning/info).

Press the Test key.


The Test LED is illuminated.

4-10 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

The test steps are displayed as they are


performed.

4.1.5.3 Priming during the test

 Basic condition

The T1 test has been selected.

 Starting the program

Press the Prime key.


The Test LED is illuminated.
The Prime LED is illuminated.
Press the Start/Reset key for precirculation.
Precirculation can only be started after
completion of the display test.

Status indicator light turns yellow


(warning/info).

T1 test
Prime
Message displayed briefly
or
T1 test
Prime/Circulation

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-11


Chapter 4: Operation

If a rinse volume has been defined in the


SETUP:
Message displayed briefly
The screen returns to the test steps display.

 Setting the blood pump rate

Rate: ml/h (Ø:ml) The Operation (green) LED is illuminated.


Blood pump is rotating.
Start
Stop The arterial blood pump fills the blood line up
to the venous bubble catcher.
A delivery rate > 100 ml/min will
automatically be reset to 100 ml/min.
The delivery rate can be changed by the
operator as desired.

Use the key  or the key  to select the


desired delivery rate.
Pressing the key for more than
> 3 seconds: Will accelerate the change
rate.

 Delivery stops

T1 test
Prime end
Message displayed briefly
or The blood pump stops as soon as the venous
bubble catcher is filled or after 1 to 5 minutes
at the latest (depending on the setting in the
SETUP) or if the rinse volume set in the
SETUP has been reached.
The screen returns to the test steps display.

4-12 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Status indicator light turns red (alarm).

The Test LED is illuminated.


The Mute LED is flashing.
Audible signal
cleared automatically

It may be necessary to raise the level in the


venous bubble catcher.
Press the  key to set the desired level.

Press the Start/Reset key.


The blood pump starts running and the
venous line clamp opens. Fluid is
recirculated.

The Test LED is illuminated.


The Prime LED is illuminated.
The Mute LED is dark.

Status indicator light turns yellow


(warning/info).

Message displayed briefly


The screen returns to the test steps display.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-13


Chapter 4: Operation

 Interrupting priming of the blood line

Rate: ml/h (Ø:ml) Press the Start/Stop key.


The Operation (green) LED is dark.
Start
Stop
Continue by pressing the key again.

 Premature termination

Press the Start/Reset key or the Prime key.


Continue priming by pressing the Prime key
again or press the Start/Reset key to
continue precirculation.

4.1.5.4 Test steps

 Parallel test

The test steps are performed in parallel. The


test steps currently in progress are
highlighted.
The test starts with the display test.
During the display test, verify the proper
function of the
– status LED's
– alarm LED's
– bargraph displays
– screen
– audible alarm

4-14 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

 Serial test

The test steps are performed consecutively.


The test step currently in progress is
highlighted.
During the display test, verify the proper
function of the
– status LED's
– alarm LED's
– bargraph displays
– screen
– audible alarm

4.1.5.5 End

 With the blood line not filled

T1 Test passed
Message displayed briefly

Then the Dialysis screen will be displayed

The Test LED is dark.


The Prime LED is illuminated.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-15


Chapter 4: Operation

 With the blood line filled

Preparation
Display message

The Start/Reset LED is illuminated.

4.1.5.6 Errors

The Test LED is flashing.


The Mute LED is flashing.
Audible signal

T1 Test failed
Display message

Press the Test key.

4-16 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

The error code displays in the “Error” field.


e.g. 1

Press the Test key.


The Test LED is illuminated.
The Mute LED is dark.

The test step which the device failed to pass


is displayed and repeated.
If the test step is successfully passed, the test
will be completed.

If the device fails to pass the test step a


second time, the error will be displayed
together with the error code.

Note
The following error messages can be acknowledged by pressing the
Test key:
– Skip Battery?
– Skip Diasafe?

Note
If the message Skip Battery? is acknowledged by pressing the Test
key, however an audible alarm might not be generated should a power
failure occur.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-17


Chapter 4: Operation

Skip Battery?
Example: Skip Battery?
Display message

Press the Test key.


The Test LED is flashing.
Audible signal

Are you sure?


Display message

Press the Test key.

If the problem persists, call the service.

4.1.5.7 Interruption

The T1 test will be interrupted if one of the required starting conditions


is not fulfilled anymore (see chapter 4.1.5.1, page 4-9).
The test will be continued after the problem has been corrected.

4.1.5.8 Stop

The test can only be stopped by turning the device off.

4-18 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Press the On/Off key.


On/Off LED stops lighting.

4.1.6 Blood pump

Caution
Delivery operation of the pump(s) with open doors:
(Blood pump, optional Single-Needle pump):
When the doors are open and the rotor of the pump(s) is running, make
sure that no objects, such as fingers, hair or ball point pens, come into
contact with the rotor (risk of injury).

4.1.6.1 Inserting the arterial blood lines

Rate: ml/h (Ø:ml) 1. Open the cover.


2. Press the Start/Stop key and keep it
Start
Stop pressed until the rotor stops.

1. Insert the line segment on the left.


2
2. Press the Start/Stop key and keep it
pressed until the rotor stops.
5
3. Insert the line segment on the right.
4. Close the cover.
4
5. Connect the pressure measuring line to
the pressure port.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-19


Chapter 4: Operation

Connect the arterial blood line to the blood


inlet port of the dialyzer.

4.1.6.2 Selecting the line diameter

Rate: ml/h (Ø:ml) Should the blood pump rotor be running:


Press the Start/Stop key.
Start
Stop
The Operation (green) LED is dark.

Rate: ml/h (Ø:ml) Press the  key and the  key


simultaneously.
Start
The current value of the line diameter is
Stop indicated in mm and flashing digits.

Rate: ml/h (Ø:ml) Use the  key or the  key to select the
desired value.
Start
(Pressing the key for more than 3
Stop
seconds: will accelerate the change
rate.)
Selectable range:
2 to 10 mm in increments of 0.2 mm

Rate: ml/h (Ø:ml) Use the Start/Stop key to save.


(The value is displayed for approx. 2
seconds)
Start
Stop The delivery rate of the blood pump is
reset to 0.

Rate: ml/h (Ø:ml) Use the  key to set the delivery rate.

Start
Stop

4-20 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

4.1.7 Heparin pump

4.1.7.1 Positioning the slide carriage

Rate: ml/h (Bolus:ml) Press the  key.


( :h.min)
Rate The slide carriage will move to the fully
open position.
Bolus Start
Stop

Note
When the slide carriage moves to the fully open position, the bolus data
is reset to 0.

1. Connect a syringe filled with heparin to the


heparin line of the arterial blood lines.
2. Insert the syringe.

Rate: ml/h (Bolus:ml) Press the  key and keep it pressed until the
( :h.min)
Rate slide carriage is in the start position.
Bolus Start
Stop

Note
The plate of the syringe plunger must engage in the slide carriage.

Note
The syringe wings must be in the syringe wing slot.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-21


Chapter 4: Operation

Rate: ml/h (Bolus:ml) Use the  key to prime the heparin line
( :h.min)
Rate ensuring it is free from air.
Bolus Start
Stop

4.1.7.2 Setting the delivery rate

Rate: ml/h (Bolus:ml) Press the Rate key.


Rate
( :h.min)
The display is flashing.
Bolus Start
Stop

Rate: ml/h (Bolus:ml) Use the  key or the  key to select the
( :h.min)
Rate desired value.
Start
(Pressing the key for more than 3
Bolus Stop seconds: will accelerate the change
rate.)
Selectable range:
0.1 up to 10 ml/h
in increments of 0.1 ml/h

Rate: ml/h (Bolus:ml) Press the Rate key to accept the selected
( :h.min)
Rate value.
Start
The display will continue flashing until
Bolus Stop the set time has been accepted by
pressing the Rate key.
During this time the heparin pump
delivers at the previous rate.

Note
Administer the heparin dose according to the physician's instructions!

Note
For the injection of an initial heparin dose use the Bolus key.

4-22 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

4.1.7.3 Setting the stop time

Rate: ml/h (Bolus:ml) After turning the device on and starting a


( :h.min)
Rate cleaning program the stop time function will
Bolus Start be active.
Stop

Stop time (green) LED is illuminated.

Rate: ml/h (Bolus:ml) Press the Clock key.


Rate
( :h.min)
The display is flashing.
Start
Bolus Stop The stop time of the previous treatment
is displayed.

Rate: ml/h (Bolus:ml) If the stop time function is deactivated (Stop


( :h.min)
Rate time (green) LED dark):
Bolus Start
Stop Use the Start/Stop key to activate the stop
time function.

Rate: ml/h (Bolus:ml) Use the  key or the  key to select the
( :h.min)
Rate desired value.
Start
(When keeping the key pressed for a
Bolus Stop longer time, the change rate will switch
from 1 minute to 10 minute steps.)
Selectable range: 0 minutes to 2 hours
in increments of 1 minute.

Rate: ml/h (Bolus:ml) Press the Clock key to accept the selected
( :h.min)
Rate value.
Start
The display will continue flashing until
Bolus Stop
the set time has been accepted by
pressing the Clock key. During this time,
the stop time previously set remains
active.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-23


Chapter 4: Operation

4.1.7.4 Turning the stop time off

Rate: ml/h (Bolus:ml) Press the Clock key.


( :h.min)
Rate The display flashes, the Stop time
(green) LED is illuminated.
Bolus Start
Stop

Rate: ml/h (Bolus:ml) Use the Start/Stop key to turn the stop time
( :h.min)
Rate function off.
Start
The Stop time (green) LED is dark.
Bolus Stop

Rate: ml/h (Bolus:ml) Confirm the function by pressing the Clock


( :h.min)
Rate key.
Start
The Stop time (green) LED is dark,
Bolus Stop
heparinization will be continued without
stop time.

4.1.8 Air detector

4.1.8.1 Inserting the venous blood lines

Connect the venous blood line to the blood


outlet port of the dialyzer.
Install the venous bubble catcher in the
bubble catcher holder.

4-24 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Note
Place the filter in the venous chamber approx. 1 cm below the lower
edge of the bubble catcher holder.

Caution
The following precautions for the use of the air detector must be
observed:
– No ultrasound-conducting media may be used.
– Blood clots can cause a functional failure of the air detector.

1. Open the flap to the right.


4
2. Manually open the venous line clamp and
insert the line into the optical detector.
3. Check that the line is correctly inserted
and then close the flap.
4. Connect the venous pressure measuring
line to the venous pressure port (Luer-
lock).

Caution
Never remove the blood line from the optical detector and from the
venous line clamp during the dialysis treatment.

4.1.9 Extracorporeal blood circuit

Regarding the regulations for the application of hemodialysis devices the following has to be observed
before and during the treatment:

Caution
Aseptic technique:
Use aseptic techniques for all bloodside connections and all
connections in the area where sterile solutions are to be used.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-25


Chapter 4: Operation

Caution
Preventing contamination:
To prevent cross-contamination only use blood lines with hydrophobic
filters connected to the pressure lines.
Connect the hydrophobic filters so that an ingress or loss of air is not
possible and that any wetting by fluid is reliably avoided, also in case of
pressure fluctuations.
If a hydrophobic filter has become wet, the blood lines must be
replaced.
On blood lines with additional connection sites, a replacement pressure
line can be connected (accessory available from Fresenius Medical
Care).
The blood in the pressure line must not be forced back by means of a
syringe. This could damage the hydrophobic membrane and thus lead
to a contamination.
If fluid may have passed the hydrophobic filter, the device must be
checked for contamination after completion of the treatment. If the
device is contaminated, it has to be taken out of service. Before
recommissioning the device, all affected parts must be disinfected or
replaced in accordance with the manufacturer's specifications.

Caution
Before the treatment, check:
– The safe connection of all connection sites of the blood lines.
– The tightness of the blood lines during and after priming.
– Retighten the connections and replace the blood lines, if necessary.
– The absence of air in the blood lines as well as absence of kinks,
tensions and twists and the correct position of all fluid levels.
To be observed when working on the blood lines during the treatment:
If the position of the blood lines or of one of their components is
changed, the correct position of all blood lines must be restored
afterwards, above all the correct position of the line guides.
During the treatment check at appropriate intervals:
– The condition of the patient.
– The function of the hemodialysis device and the extracorporeal
blood circuit. Pay particular attention to the venous insertion site, as
a possible dislocation of the venous cannula may not always be
detected by the pressure monitoring system.
– The blood lines for leakages and entry of air or possible loosening of
connections, for absence kinks, tensions and twists.
– The fluid level in the venous bubble catcher. Correct it, if required.

4-26 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Caution
When inserting the blood lines, the following precautions must be
respected:
– The blood lines have to be free of kinks, tension and twists and must
not be jammed (risk of hemolysis). Use the line holders provided.
– Ensure the correct position of the screwed connections, especially
of the connection sites to the patient, the dialyzer and the device and
check or correct them during the treatment if necessary. Take the
appropriate measures if required (e.g. retightening of the Luer Lock
connection or replacement of the blood lines).
– Check the protective caps for tight fit and tighten them if necessary.
– The lines for the supply of infusions should always be clamped,
except if they are needed.
– During long-term operation, the blood lines must be changed after
24 hours at the latest.
– Do not use cannulas with a diameter of > 20 gauge to pierce the
septum of the injection sites. Insert the cannula vertically and in the
center of the septum. Disinfect the injection sites with 70% alcohol
before use.
– The blood pump must be set to the diameter of the pump segment,
refer also to the product label of the blood lines. If a wrong line
diameter is set, this may cause significant deviations in the blood
flow and thus in the dialysis dose.
– Materials which come directly or indirectly into contact with blood
are: Plasticized PVC, unplasticized PVC, polyethylene,
polycarbonate, latex-free rubber, ABS.
– The minimum temperature of the blood lines during use is 18 °C.

Caution
Venous alarm limit:
It is important to set the lower venous alarm limit as close as possible to
the actual value of the venous pressure.

Caution
Dialysate couplings:
Check the dialysate couplings for tightness when connecting them.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-27


Chapter 4: Operation

Fig.: Double-Needle dialysis blood lines

Priming the extracorporeal blood circuit with a saline solution bag

4-28 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Fig.: Single-Needle dialysis blood lines

4.1.9.1 Priming

Connect the arterial connector of the blood


line to the saline solution bag.
Break the cone on the saline bag.
Connect the venous connector of the blood
line to the rinse bag.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-29


Chapter 4: Operation

Press the Prime key.


The Prime LED is illuminated.
The Air Detector alarm indicator is
illuminated.

Status indicator light turns yellow


(warning/info).

Prime
Display message

Rinse-volume: xxxx ml
Message displayed briefly if a rinse volume
has been defined in the SETUP.

4-30 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

4.1.9.2 Setting the blood pump rate

Rate: ml/h (Ø:ml) The Operation (green) LED is illuminated.


Blood pump is rotating.
Start
Stop
The arterial blood pump fills the blood line up
to the venous bubble catcher.
A delivery rate > 100 ml/min will
automatically be reset to 100 ml/min.
The delivery rate can be changed by the
operator as desired.

Use the key  or the key  to select the


desired delivery rate.
Pressing the key for more than
> 3 seconds: Will accelerate the change
rate.

4.1.9.3 Delivery stops

Prime end
As soon as the venous bubble catcher is
filled:
Message displayed briefly
Rinsing starts automatically.

When the preset priming time has elapsed


and the venous bubble catcher has not yet
been primed:
Press the  key to set the desired level.

Press the Start/Reset key to start the Rinse


program.

Dialysis
Rinse-volume reached
The preset rinse volume is delivered into the
collection bag, and the blood pump stops
automatically.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-31


Chapter 4: Operation

4.1.9.4 Interrupting the priming program

Rate: ml/h (Ø:ml) Press the Start/Stop key.


The Operation (green) LED is dark.
Start
Stop
Continue by pressing the key again.

4.1.9.5 Premature termination

Press the Start/Reset or the Prime key.


Press the Prime key a second time to
continue priming.

4.1.10 Dialysate side

4.1.10.1 Functional checks prior to each dialysis treatment

Note
The functional checks must be performed by the operator prior to each
dialysis treatment.
– Verification of the dialysate composition:
Check the conductivity displayed on the monitor with the
specifications on the acid / acetate container. (Observe the settings
for sodium and bicarbonate in the Dialysate menu!)

Caution
If the mixing ratio was set in the SETUP to be individually adjustable,
always make sure:
– to check the dialysate for correct physiological composition before
initiating dialysis.
– that the individually adjustable mixing ratio and the bibag® function
are not used simultaneously.

4-32 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

4.1.10.2 Adjusting the acetate / acid pump

To set the following parameters press the


Dialysate Menu key to display the Dialysate
menu.

The mixing ratio defined in the SETUP will be


displayed.
Use the Arrow keys to select the Base Na+
field.
Use the keys 0–9 or the +/– keys to adjust the
Base Na+.
Use the Arrow keys to select the Prescribed
Na+ field.
Use the keys 0–9 or the +/– keys to adjust the
Prescribed Na+.
Selectable range: 125 to 150 mmol/l
Prescribed Na+ = Base Na+ ± 13 mmol/l
The adjustment range between Base
Na+ and Prescribed Na+ can be
changed in the SETUP.
(Adjustment range: ±0 mmol/l to
±13 mmol/l)

The Base Na+ value is indicated on the


containers or the package inserts.

4.1.10.3 Adjusting the bicarbonate pump

Note
The respective sodium and bicarbonate ion concentrations are
specified in the product information.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-33


Chapter 4: Operation

Use the Arrow keys to select the


Bicarbonate field.
Use the +/– keys to adjust the bicarbonate.
Selectable range: –8 to +8 mmol

4.1.10.4 Setting the conductivity limits

 Repositioning of the CD window

Use the Arrow keys to select the Position


field.
Use the +/– keys to change the position of the
conductivity window.

Caution
The alarm limits of the conductivity display must be set around the
expected value.
The actual value in the conductivity display must have attained the
expected target value after a maximum of 10 minutes.
Should this not be the case, the actual value must first be checked in
the laboratory. If the result turns out to be negative, the device and/or
the concentrates should be checked.

4-34 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

 Centering the CD window around the actual value

Use the Arrow keys to select the Centre


field.

Press the Conf key.


The alarm limits are centered around the
actual value.

4.1.10.5 Taking a sample

1. Connect a syringe (e.g. 10 ml Luer Lock)


to the Luer Lock of the sampling valve.
This valve is located in the dialyzer supply
line.
2. Press the key and keep it pressed.
3. Lock the key using the pin.
4. Draw back the plunger
5. Release the pin. The key will automatically
close the valve.

4.1.10.6 Connecting the dialyzer

Warning
Shunt Cover open
Open the shunt interlock flap.
Message: Warning

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-35


Chapter 4: Operation

The Flow LED is flashing

Connect the inflow dialysate line to the


dialyzer (on the venous outlet side).
Connect the outflow dialysate line to the
dialyzer (on the arterial inlet side).

Close the shunt interlock flap.


The conductivity window is set.
The Flow LED is illuminated.
Check the dialysate flow and adjust, if
necessary.

4.1.10.7 Changing the dialysate flow

Press the Dialysate Menu key.

4-36 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Use the Arrow keys to select the Flow field.


Use the keys 0–9 or the +/– keys to adjust the
flow.
Selectable rates: 300, 500, 800 ml/min

4.1.10.8 Changing the dialysate temperature

Use the Arrow keys to select the


Temperature field.
Use the Arrow keys or the +/– keys to adjust
the temperature.
Selectable range: 35.0 to 39.0 °C
in 0.5 °C increments

Press the Conf key.

4.1.10.9 Rinsing the dialyzer

If the dialyzer is to be prepared with a UF rate:


Press the UF Menu key.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-37


Chapter 4: Operation

Use the Arrow keys to select the UF Goal


field and set it to 0 by using the C key.
Use the Arrow keys to select the UF Time
Left field and set it to 0 by using the C key.
Use the Arrow keys to select the UF Rate
field.
Use the Arrow keys or the +/– to set the
desired rate.

Note
When the optical detector senses light and the dialysate pressure is
positive during preparation, the UF rate is automatically set to 500 ml/h.
When entering and starting UF parameters, only the values entered are
relevant.

Press the UF ON/OFF key.


The UF LED is illuminated.

4.2 Treatment

4.2.1 Ultrafiltration

Note
If the dialyzer has been prepared with a UF rate, the UF volume must
be erased.

4-38 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

4.2.1.1 Deleting the UF volume

Select the System parameters menu on the


screen.
Select Yes in the Delete treatment
parameters field by using the +/– keys.
Use the Conf key to save.

Note
All saved treatment data will be erased with this function.

4.2.1.2 Entering UF parameters

 Maximum values

UF Rate max. 4000 ml/h (programmable with DIP switch)

UF Goal 9990 ml

UF Time 9 hours 59 minutes

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-39


Chapter 4: Operation

 UF Autostart

The ultrafiltration will start automatically as soon as the optical detector


senses dark.
The requirements are:
– UF data entered correctly.
– UF Autostart activated in the SETUP.

 Starting position

Press the UF Menu key to select the


Ultrafiltration menu.

If treatment is to be performed with the UF


data which are displayed and have been
defined in the SETUP:
Press the Conf key.

 Goal function with fixed rate

Use the Arrow keys to select the UF Goal


field.
Use the Arrow keys or the +/– keys to set the
UF goal.
Use the Arrow keys to select the UF Rate
field.
Use the Arrow keys or the +/– to set the
desired rate.
The UF time left will automatically be
recalculated.

4-40 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

 Goal function with fixed time

Use the Arrow keys to select the UF Time


Left field.
Use the Arrow keys or the +/– to set the
desired time.
Use the Arrow keys to select the UF Goal
field.
Use the Arrow keys or the +/– keys to set the
desired UF goal.
The UF time left will automatically be
recalculated.

 Timer rate function (no UF Autostart)

Use the Arrow keys to select the UF Goal


field.
Press the C key to reset the UF goal to 0.
Use the Arrow keys to select the UF Rate
field.
Use the Arrow keys or the +/– to set the
desired rate.
Use the Arrow keys to select the UF Time
Left field.
Use the Arrow keys or the +/– to set the
desired time.

 Rate function (no UF Autostart)

Use the Arrow keys to select the UF Goal


field.
Press the C key to reset the UF goal to 0.
Use the Arrow keys to select the UF Time
Left field.
Press the C key to reset the time to 0.
Use the Arrow keys to select the UF Rate
field.
Use the Arrow keys or the +/– to set the
desired rate.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-41


Chapter 4: Operation

Note
If only the UF rate is entered for ultrafiltration, check the UF rate
displayed in the Dialysis menu for plausibility after saving the data.

Note
If only the UF rate is entered for ultrafiltration, the stop time function of
the heparin pump will be turned off.

 Timer function (no ultrafiltration and no UF Autostart)

Use the Arrow keys to select the UF Rate


field.
Press the C key to reset the UF rate to 0.
Use the Arrow keys to select the UF Time
Left field.
Use the Arrow keys or the +/– to set the
desired time.

After all parameters have been entered:


Press the Conf key.

4.2.1.3 Starting ultrafiltration / timer

Press the UF ON/OFF key.


The UF LED is illuminated.

4-42 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

4.2.1.4 Stopping / interrupting uItrafiltration / timer

Press the UF ON/OFF key.


The UF LED is dark.
The UF pump is not running.
Timer of the UF time left stops.

4.2.1.5 Continuing ultrafiltration / timer

Press the UF ON/OFF key again.


The UF LED is illuminated.

4.2.1.6 Changing UF data

Use the UF ON/OFF key to interrupt the


ultrafiltration.
The UF LED is dark.
The UF pump is not running.
Timer of the UF time left stops.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-43


Chapter 4: Operation

Press the UF Menu key to select the


Ultrafiltration menu.

Use the Arrow keys to select the desired


data field.
Use the Arrow keys or the +/– keys to set the
desired value.
All other parameters will be calculated
automatically.

Use the Conf key to save.

Use the UF ON/OFF key to continue the


ultrafiltration.
The UF LED is illuminated.

4-44 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

4.2.2 Double-Needle dialysis

4.2.2.1 Connecting the patient

Rate: ml/h (Ø:ml) Press the Start/Stop key of the blood pump.
The Operation (green) LED is dark.
Start
Stop
The arterial blood pump stops.

Connect the arterial line to the patient.


Connect also the venous line if the saline in
the blood line is to be given to the patient.

Rate: ml/h (Ø:ml) Arterial blood pump:


Set the delivery rate to the desired value.
Start
Stop

Rate: ml/h (Ø:ml) Press the Start/Stop key of the blood pump.
The Operation (green) LED is illuminated.
Start
Stop The blood pumps starts immediately
(provided there is no blood alarm)

The optical detector senses dark.


Status indicator light turns yellow
(warning/info).
Preparation end Display message
The alarm limits (arterial, venous) are set
automatically.
The TMP limits are set after a short delay
(depending on the UF coefficient).
The time delay increases with a low UF
coefficient and decreases with a high UF
coefficient.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-45


Chapter 4: Operation

Caution
Make sure that the TMP monitoring limits stay centered around the
actual value when using high-flux dialyzers.

The blood pump stops.


The venous line clamp closes.
Audible signal
The Start/Reset LED is flashing.
The Mute LED is flashing
Connect the venous line to the patient (unless
this has already been done).

Check the level in the venous bubble catcher


and adjust, if necessary.

4.2.2.2 Performing the dialysis

Press the Start/Reset key.


The Start/Reset LED is illuminated
If UF Autostart is set in the SETUP:
The ultrafiltration starts automatically
with the parameters entered.

Display message

Dialysis Status indicator light turns green (operation).

4-46 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Caution
When using high-flux dialyzers and selecting low UF rates there is a
possibility of local backfiltration. Backfiltration depends on:
– the type of high-flux dialyzer
– the flow resistance on the dialysate and the blood side
– the viscosity of the blood

Rate: ml/h (Bolus:ml) Press the Start/Stop key of the heparin


( :h.min)
Rate pump.
Bolus Start
Stop The Operation (green) LED is illuminated.
The heparin pump is delivering.

Press the UF ON/OFF key.


The UF LED is illuminated.

4.2.2.3 Administering a heparin bolus

 Heparin

Rate: ml/h (Bolus:ml) Check the bolus volume:


Rate
( :h.min)
Press the Bolus key of the heparin pump.
Start
Bolus Stop The bolus volume already administered
will be indicated.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-47


Chapter 4: Operation

Rate: ml/h (Bolus:ml) Administering a bolus:


Rate
( :h.min)
Press the Bolus key for more than
Bolus Start
Stop 2 seconds.
Display: 0.0
The heparin pump will administer the
bolus in 0.1 ml increments.
After releasing the key, the display will
show for 5 seconds the bolus volume
injected.
(The bolus volume administered will be
added to the bolus volume stored.)
Then the delivery rate will be displayed
Maximum bolus dose: 5 ml
Maximum total bolus volume:
1x syringe capacity

 Cumulated heparin volume

Rate: ml/h (Bolus:ml) Cumulated heparin volume.


Rate
( :h.min)
Press the Rate key for more than 2 seconds.
Bolus Start
Stop
Display: XXX
The cumulated heparin volume is
displayed.

Rate: ml/h (Bolus:ml) Erase the cumulated heparin volume.


Rate
( :h.min)
Press the Start/Stop key.
Bolus Start
Stop
Display 000
The cumulated heparin volume
(including the bolus volume) is erased.

Rate: ml/h (Bolus:ml) Exit the cumulated heparin volume function.


Rate
( :h.min)
Press the Rate key again.
Start
Bolus Stop The "delivery rate" display is active
again.

 Physiological saline solution

When adding physiological saline solution (saline) in the venous bubble catcher, the blood may be diluted
to a color which the optical detector no longer senses as blood.

The optical detector senses light.


Status indicator light turns yellow
(warning/info).

4-48 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

No blood sensed by OD
Menu options
Continue treatment
The blood pump stops.
Cancel treatment
The venous clamp closes.
Audible signal.
The alarm limits remain centered around the
actual value.

Press the Conf key.


Dialysis will be continued with the alarm limits
centered around the actual value.

4.2.3 Single-Needle Click-Clack

This procedure should be used in exceptional cases only, as the stroke volumes and thus the respective
recirculation may vary widely.

The arterial and the venous blood line are connected with a Y-piece to the vascular access.

4.2.3.1 Selecting the treatment mode / entering treatment data

Use the Arrow keys to select the Treatment


mode field.

Press the Conf key.

Use the Arrow keys to select the SN - click


- clack field.
Use the +/– keys to set the window to ON.

Changing specified values:


Use the Arrow keys to select the
Upper Limit and then the Lower Limit field.
Use the +/– keys to set the desired values.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-49


Chapter 4: Operation

Press the Conf key.

SN Click Clack Dialysis


Display message

4.2.3.2 Changing treatment data / stopping treatment

Use the Arrow keys to select the Treatment


mode field.

Press the Conf key.

Use the Arrow keys to select the


Upper Limit and then the Lower Limit field.
Use the +/– keys to set the desired values.

To stop:
Use the Arrow keys to select the SN - click
- clack field.
Use the +/– keys to set the window to OFF.

Press the Conf key.

4-50 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

4.2.4 Isolated ultrafiltration ISO UF

Isolated ultrafiltration can be started at any time and can be repeated as often as necessary.

The parameters entered at the beginning of the treatment (UF Goal and UF Time) must be taken into
consideration.

The total volume to be removed (UF Goal), the total treatment time (UF Time Left) or the UF Goal and the
UF Rate must always be programmed.

4.2.4.1 Selecting the treatment mode

1. Use the UF ON/OFF key to turn the


ultrafiltration off.
The UF LED is dark.
2. Press the UF Menu key to select the
1 Ultrafiltration menu.

Use the Arrow keys to select first ISO Goal,


the ISO Time.
If only the ISO time is entered, the
current UF rate will be automatically
calculated and displayed.

Use the Arrow keys or the +/– keys to set the


desired values.
The calculated ISO UF Rate displays in the
ISO Rate field.

Press the Conf key.

ISO-UF start?
Display message

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Chapter 4: Operation

Use the UF ON/OFF key to start the ISO-UF.


The UF LED is illuminated.
The dialysate flow is automatically switched
to Off.

ISO R = XXX t = X:XX


Display message:
ISO Rate and ISO Time left
If only the ISO time is entered, only the
remaining ISO time will be shown on the
display.

Note
When the isolated ultrafiltration is completed, the dialysate flow and the
determined UF parameters will automatically be recommenced.
Conductivity alarm and temperature alarm are suppressed for
3 minutes.

4.2.4.2 Changing ISO UF data / stopping ISO UF

Use the UF ON/OFF key to turn the


ultrafiltration off.
The UF LED is dark.

4-52 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Press the UF Menu key to select the


Ultrafiltration menu.

Use the Arrow keys to select successively


the ISO Goal, ISO Time and ISO Rate fields.
Use the +/– keys to set the desired values.

To stop:
Use the Arrow keys to select the ISO UF
field.
Use the +/– keys to set the window to Off.

Press the Conf key.

4.2.4.3 Manually entering the sequential ultrafiltration

Use the UF ON/OFF key to turn the


ultrafiltration off.
The UF LED is dark.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-53


Chapter 4: Operation

Press the UF Menu key to select the


Ultrafiltration menu.

Use the Arrow keys to select the UF Goal


and the UF Time Left fields.
Use the +/– keys to set the desired values.

Press the Conf key.

Use the Flow ON/OFF key to turn the


dialysate flow off.

Flow - off
Display message
Audible signal after 30 minutes.
(adjustable in SETUP: 30, 45,
60 minutes)

4-54 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Use the UF ON/OFF key to turn the


ultrafiltration on.
The UF LED is illuminated.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-55


Chapter 4: Operation

4.2.5 Sodium and UF profiles

4.2.5.1 General notes

The following values should have been entered before selecting profiles:
– Base Na+, Prescribed Na+ and Bicarbonate.
– UF goal (minimum UF goal: 200 ml)
– UF time (minimum UF profile time: 2 hours)
– UF Rate

Caution
When selecting Na profiles the following must be observed:
The balancing neutrality of the profiles was calculated for a dialysis
dose of KT/V = 1.2. In case of higher deviations (KT/V > 1.4;
KT/V < 1.0) the balancing neutrality may not always be achieved.

minimum continuous UF rate:

Profiles 1 to 6 100 ml/h

minimum continuous UF rate:

Profile Rate (ml/h)

1 3000

2 3000

3 2660

4 2050

5 2050

6 1250

4-56 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Sodium
Ultrafiltration

The above table shows the profile combinations available.


The device will prompt the operator in the event of missing or incorrectly entered parameters.

4.2.5.2 Entering a UF profile without sodium profile

Press the UF Menu key to select the


Ultrafiltration menu.

Use the Arrow keys to select the UF Profile


field.
Use the Arrow keys or the +/– keys to set the
desired profile.
The device will prompt the operator in
the event of missing or incorrectly
entered parameters.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-57


Chapter 4: Operation

Press the Conf key.


The profile number is shown in the yellow UF
Profile circle in the Profiles field.

Press the UF ON/OFF key to start the profile.

4.2.5.3 Entering a UF profile with sodium profile

Press the UF Menu key to select the


Ultrafiltration menu.

Use the Arrow keys to select the UF Profile


field.
Use the Arrow keys or the +/– keys to set the
desired profile.
The device will prompt the operator in
the event of missing or incorrectly
entered parameters.

4-58 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Press the Conf key.


The profile number is shown in the yellow UF
Profile circle in the Profiles field.

Press the Dialysate Menu key to select the


Dialysate menu.

Use the Arrow keys to select the Na Profile


field.
Use the Arrow keys or the +/– keys to set the
desired profile.
The device will prompt the operator in
the event of missing or incorrectly
entered parameters.

Use the Arrow keys to select the Start Na+


field.
Use the Arrow keys or the +/– keys to adjust
the Start Na+.

Note
In this mode the device automatically adjusts the preset UF profile
number to match the selected Na profile and informs the operator.

Press the Conf key.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-59


Chapter 4: Operation

Press the UF ON/OFF key to start the profile.

Note
The device will prompt the operator in the event of missing or incorrectly
entered parameters.
Profiles, UF and dilution parameters cannot be reprogrammed while the
program is in progress.
The profile must be stopped and restarted with the altered parameters.

4.2.5.4 Entering a sodium profile without UF profile

In the UF menu select the UF Profile field


and press the C key to reset the profile to 0
(deselection).

Press the Dialysate Menu key to select the


Dialysate menu.

4-60 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Use the Arrow keys to select the Na Profile


field.
Use the Arrow keys or the +/– keys to set the
desired profile.
The device will prompt the operator in
the event of missing or incorrectly
entered parameters.

Use the Arrow keys to select the Start Na+


field.
Use the Arrow keys or the +/– keys to adjust
the Start Na+.

Press the Conf key.

Press the UF ON/OFF key to start the profile.

4.2.5.5 Entering a sodium profile with UF profile

Press the Dialysate Menu key to select the


Dialysate menu.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-61


Chapter 4: Operation

Use the Arrow keys to select the Na Profile


field.
Use the Arrow keys or the +/– keys to set the
desired profile.
The device will prompt the operator in
the event of missing or incorrectly
entered parameters.

Use the Arrow keys to select the Start Na+


field.
Use the Arrow keys or the +/– keys to adjust
the Start Na+.

Press the Conf key.

Press the UF Menu key to select the


Ultrafiltration menu.

Use the Arrow keys to select the UF Profile


field.
Use the Arrow keys or the +/– keys to set the
desired profile.
The device will prompt the operator in
the event of missing or incorrectly
entered parameters.

4-62 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Press the Conf key.


The profile number is shown in the yellow UF
Profile circle in the Profiles field.

4.2.5.6 End of program

UF goal reached
Display message
Status indicator light turns yellow
(warning/info).
The UF LED is dark.
The UF pump is not running.
Audible signal

The Start/Reset LED is flashing.


The Mute LED is flashing.
The TMP alarm limits are fully open.

Press the Start/Reset key.


The Start/Reset LED is illuminated.
The Mute LED is dark.

Info message
Reinfusion?
Info message

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-63


Chapter 4: Operation

4.2.5.7 Stopping the program

Press the UF ON/OFF key.


The UF LED is flashing.

Profiles paused
Display message
Continue Profile
Stop UF Profile Use the Arrow keys to select the desired
Stop both profiles
function.

Press the Conf key.

4.2.6 DIASAFE® plus

4.2.6.1 Display during treatment

Rinsing diasafe
Message displayed briefly
Retentate rinsing (approx. every 60 minutes
for 5 balancing chamber switching cycles)
Device in bypass

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Chapter 4: Operation

4.3 End of treatment

4.3.1 Double-Needle dialysis

Status indicator light turns yellow


(warning/info).

UF goal reached
Display message, e.g. UF goal reached

The TMP alarm limits are fully open.


The UF LED is dark.
The UF pump stops.
The Start/Reset LED is flashing.
The Mute LED is flashing.
Audible signal.

Press the Start/Reset key.


The Start/Reset LED is illuminated.
Turn the heparin pump off, if necessary.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-65


Chapter 4: Operation

Info message
Reinfusion?
Info message

4.3.2 Reinfusion

4.3.2.1 Procedure

Info message
Reinfusion?
Info message

Press the Conf key.

Status indicator light turns yellow


(warning/info).
The blood pump stops.
The venous line clamp closes.

Reinfusion
Display message

The arterial, venous and TMP alarm limits are


fully open for 5 minutes.

4-66 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Disconnect the arterial line from the patient


access and connect it to the reinfusion
solution.
Break the cone.

Rate: ml/h (Ø:ml) Use the  key to reduce the delivery rate of
the blood pump.
Start
Stop

Press the Start/Reset key.


Reinfusion starts (max. 5 minutes).
The Start/Reset LED is illuminated.

Dialysis end
Display message
The optical detector senses light.
The blood pump stops.
The venous line clamp closes.
Audible signal

To continue reinfusion:
Press the Start/Reset key.
The Start/Reset LED is illuminated.

Preparation
Display message
The blood pump starts.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-67


Chapter 4: Operation

Rate: ml/h (Ø:ml) To terminate the treatment:


Use the Start/Stop key to turn the blood
Start
Stop pump off.
The Operation (green) LED is dark.
Disconnect the venous blood line from the
patient.

4.3.2.2 Repeating reinfusion

Info message
Reinfusion?
Info message
The reinfusion time has elapsed, before the
optical detector senses light.

Press the Conf key.

Reinfusion
Display message

Use the Start/Reset key to restart the


reinfusion.
The Start/Reset LED is illuminated.

4.3.2.3 Skipping reinfusion

Info message
Reinfusion?
Info message

4-68 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

Use the Start/Reset key to skip the reinfusion


function.
The Start/Reset LED is illuminated.

Dialysis
Display message

4.3.2.4 Stop

Use the Arrow keys to select the Alarm


limits menu and enter it by using the Conf
key.
Use the Arrow keys to select the Reinfusion
field.
Use the +/– keys to set reinfusion to OFF.

Press the Conf key.

Dialysis
Display message

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-69


Chapter 4: Operation

4.3.3 Stopping the treatment

4.3.3.1 Manually stopping the treatment

Use the UF ON/OFF key to turn the


ultrafiltration off.
The UF LED is dark.

Rate: ml/h (Ø:ml) Use the Start/Stop key to turn the blood
pump off.
Start
Stop The Operation (green) LED is dark.
Reduce the blood pump rate.
Disconnect the arterial line from the patient
access and connect it to the reinfusion
solution.
Break the cone.

Rate: ml/h (Bolus:ml) Turn the heparin pump off.


Rate
( :h.min)
The Operation (green) LED is dark.
Bolus Start
Stop

Rate: ml/h (Ø:ml) Use the Start/Stop key to turn on the blood
pump with reduced blood flow.
Start
Stop The Operation (green) LED is illuminated.

The optical detector senses light.


Status indicator light turns yellow
(warning/info).

4-70 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

No blood sensed by OD
Menu options
Continue treatment
The blood pump stops.
Cancel treatment
The venous clamp closes.
Audible signal
Empty the bibag® (see chapter 4.4.2.1,
page 4-85).
The alarm limits remain centered around the
actual value.

The Start/Reset LED is flashing.


The Mute LED is flashing.
Use the  key or the  key to select the
Cancel treatment field.

Press the Conf key.

or

Leave the cursor bar on the Continue


Treatment field, which is highlighted by a
green background.
Press the Start/Reset key.

Preparation
Display message.

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-71


Chapter 4: Operation

Rate: ml/h (Ø:ml) To terminate the treatment:


Use the Start/Stop key to turn the blood
Start
Stop pump off.
The Operation (green) LED is dark.
Disconnect the venous blood line from the
patient.

4.3.3.2 Stopping treatment with reinfusion program

Use the UF ON/OFF key to turn the


ultrafiltration off.
The UF LED is dark.

Use the Arrow keys to select the Alarm


limits menu and enter it by using the Conf
key.
Use the Arrow keys to select the Reinfusion
field.
Use the +/– keys to set reinfusion to ON.

Press the Conf key.

Reinfusion
Display message
The blood pump stops. The venous line
clamp closes.

4-72 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

The alarm limits are fully open.

The Start/Reset LED is illuminated.

Disconnect the arterial line from the patient


access and connect it to the reinfusion
solution.
Break the cone.

Rate: ml/h (Ø:ml) Press the  key to reduce the delivery rate of
the arterial blood pump.
Start
Stop

Rate: ml/h (Bolus:ml) Turn the heparin pump off.


Rate
( :h.min)
The Operation (green) LED is dark.
Bolus Start
Stop

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-73


Chapter 4: Operation

Press the Start/Reset key.


The Start/Reset LED is illuminated.
The patient blood is reinfused.

Dialysis end
The optical detector senses light.
Display message
The blood pump stops.
The venous line clamp closes.
Audible signal
Empty the bibag® (see chapter 4.3.4,
page 4-75).

To continue reinfusion:
Press the Start/Reset key.
The Start/Reset LED is illuminated.

Preparation
Display message
The blood pump starts.

Rate: ml/h (Ø:ml) To terminate the treatment:


Use the Start/Stop key to turn the blood
Start
Stop pump off.
The Operation (green) LED is dark.
Disconnect the venous blood line from the
patient.

4-74 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

4.3.4 Emptying the bibag®

Dialysis end
Display message

Press the Start/Reset key.


The Start/Reset LED is illuminated.

Info message

Press the Conf key.

Emptying BIBAG
Display message
Emptying-program in progress

Fresenius Medical Care 4008 S OP-EN 4/12.10 4-75


Chapter 4: Operation

The bibag® emptying-program can be


skipped by pressing the Start/Reset key
again.

After emptying, lift the latch up to open the


bibag® flap.
Remove the bibag®.
If necessary the operator can decide to
remove the bibag® while it is emptied.

Close the bibag® flap so that it clicks into


place.

4-76 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 4: Operation

4.3.5 Emptying the dialyzer

Turn the dialyzer so that the dialysate inlet


port is in the upper position.
Open the shunt interlock. Connect the
dialysate inflow line to the right connector.
Close the shunt interlock.

Emptying-program
Display message

Open the shunt interlock as soon as air


bubbles are visible in the outlet line.
Connect the outlet line on the left connector.
Close the shunt interlock.

Remove the blood lines from the device.

Caution
It is imperative to disinfect the device after each dialysis treatment.

Note
If the device has been idle for more than 72 hours, it is recommended
to run a disinfection program before initiating the next treatment.

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Chapter 4: Operation

 Regular cleaning

Note
The following components have to be cleaned regularly:
– The dialyzer couplings and the shunt interlock
– The sealing area of the bibag® connector
– The sealing area of the concentrate suction tubes (concentrate /
bicarbonate)

Caution
After the components mentioned above were cleaned, a disinfection
has to be performed.

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Chapter 4: Operation

4.4 Special menu functions

4.4.1 Changing the DIASAFE® plus

4.4.1.1 Criteria for the filter change

– The maximum filter life (12 weeks) has been reached.


– The filter is defective (T1 test error).

4.4.1.2 Indication of a filter change

Press the Cleaning key.

 With the Cleaning program (front supplied)

The number of the cleaning procedures that


can still be performed with Sporotal® 100 is
displayed in the Cleaning (front supplied)
field.
A maximum of 11 cleaning procedures with
Sporotal® 100 is possible. (display: 11 to 1)

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Chapter 4: Operation

If it is no longer possible to perform Cleaning


(front supplied) this option will no longer be
displayed in the cleaning menu.
The DIASAFE® plus can then be cleaned
using the programs which are still available
until the maximum treatment number or filter
life is reached.

 When the filter life is exceeded

The number of the treatment days which are


still possible is displayed in the Filter change
program.
Maximum of 12 weeks possible. Only the last
7 treatment days are displayed.
(display: 7 to 1)

Filter change
only 1 day(s)
Info message, only displayed for the last 3
(Continue with [Conf] key) treatment days (display 3 to 1).

Filter change
Max filter life exceeded
Info message, is displayed if the maximum
number of treatment days has been reached.
Press the Conf key to perform a filter change
(see chapter 4.4.1.4, page 4-81).
or
Press the Esc key to override a filter change
(see chapter 4.4.1.3, page 4-81).

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Chapter 4: Operation

 In the event of a failure to pass the T1 test

Filter change
T1 Test failed
Info message
Press the Conf key to perform a filter change
(see chapter 4.4.1.4, page 4-81).
or
Press the Esc key to override a Filter
change (see chapter 4.4.1.3, page 4-81).

4.4.1.3 Overriding a filter change

Press the Esc key to override a filter change.


If the filter change is not performed, a
treatment can be performed without using the
advantages of the DIASAFE® plus.

4.4.1.4 Performing a filter change

Note
The change of the DIASAFE® plus must be entered in the Medical
Device Register (date, batch number).

Make sure that no patient is connected to the


device.

Basic conditions:
– The optical detector in the air detector
module senses light.
– The dialysate connectors (red/blue) are in
the shunt interlock.
– The shunt interlock flap is closed.
– The concentrate suction tubes must be
locked inside the rinse chamber.

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Chapter 4: Operation

Caution
Observe the following rules of hygiene when inserting the
DIASAFE® plus:
– Only use filters with undamaged packaging.
– Only remove the packaging and the protective straps immediately
before installing the filter.
– Avoid touching the connectors.

Note
A filter change must never be prematurely terminated, but must always
be properly completed.

Press the Cleaning key.

Use the Arrow keys to select the Filter


change program.

Press the Conf key.

Info message
Emptying filter
Info message

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Chapter 4: Operation

Info message
Filter changed?
Info message, after the filter has been
emptied.

1. Open the locking levers.


2
2. Slide the used filter up and out of the guide
slot.
1

Remove the protective straps 1 and 2 from


the new filter by pulling the lug.

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Chapter 4: Operation

1
1. Slide the new filter from the top into the
guide slot.
2. Close the locking levers.
2

Press the Conf key.

Info message
Filling filter
Info message

Cleaning menu
Disinfect as specified in the Operating
Instructions.

Caution
It is imperative to disinfect the device after each filter change.

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Chapter 4: Operation

4.4.2 bibag®

4.4.2.1 Emptying the bibag® (during the treatment)

If the bibag® is empty or defective, it has to be replaced during the


treatment.

Press the Dialysate Menu key.

Use the Arrow keys to select the Empty


BIBAG field.
Use the +/– keys to select Yes.

Press the Conf key.

Emptying BIBAG
Display message
Emptying-program in progress

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Chapter 4: Operation

The bibag® emptying-program can also be


started by unlocking (for approximately 1 to
5 seconds) and then re-locking the
bicarbonate suction tube.
The message Empty BIBAG? has to be
acknowledged by pressing the Conf key.

Note
Do not remove the bicarbonate suction tube from its port to prevent
leakage of fluid which might then enter the interior of the device.

After emptying, lift the latch up to open the


bibag® flap and remove the bibag®.

Close the bibag® flap so that it clicks into


place.

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Chapter 4: Operation

Lift the latch up and open the bibag® flap.

Remove the foil from the bibag®.

Connect the bibag®. Close the bibag® flap.

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Chapter 4: Operation

After the bibag® has been connected, an


automatic program will be started (lasting
approx. 35 seconds).
This program will first remove all air from the
bibag® and will then fill it.

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Chapter 4: Operation

4.4.3 Online Clearance Monitoring

 OCM starting conditions

After manual selection or an automatic start, the first OCM


measurement is initiated directly after the first CPHT. Provided the
following conditions are fulfilled:
– With UF or Na profile 1, 5 or 6: UF time  180 min.
– No Single-Needle treatment
– No SN-Click-Clack treatment
– Blood sensed by OD
If one or more of the conditions are not fulfilled, the OCM cannot be
started while the treatment is in progress; the operator will then be
informed by an appropriate error message.
The calculation of Kt/V starts when the optical detector senses blood.
This is the moment when preparation is finished.

4.4.3.1 Starting Online Clearance Monitoring

Online Clearance Monitoring can be started manually by the operator or


performed automatically for each dialysis treatment by a presetting in
the SETUP.
If Online Clearance Monitoring is started automatically, the operator can
stop it by selecting the "OCM On/Off" menu item.

Note
The treatment parameters may not be determined on the basis of the
measured parameters (Clearance, Kt/V, Plasma Na+). An independent
diagnosis must be made by the physician.
A measurement of the clearance (K) and the plasma Na+ does not
replace the therapy prescribed by the physician.

4.4.3.2 Manual start of Online Clearance Monitoring

Use the Arrow keys to select Dialysis


representation.

Press the Conf key.

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Chapter 4: Operation

Use the Arrow keys to select the individual


OCM parameters and set the desired values
by using the +/– or the 0–9 keys.
When entering V(urea), the fields for weight,
height, age and gender will be blank.
If Vurea is not known, a value for Vurea will be
calculated from the weight, the height, the
age and the gender.

Press the Conf key.

Note
A cleaning program must be performed after each OCM treatment.

4.4.3.3 Automatic start of Online Clearance Monitoring

If "OCM ON" is preset in the SETUP.


The optical detector senses blood:

Info message
Enter V(urea) ?
Info message

Note
If no valid value for the distribution volume has been entered at the
beginning of the treatment, it may be entered now or later. This
message can be acknowledged by pressing the Start/Reset key. If no
valid value is entered, Kt will be displayed instead of Kt/V.

Use the Arrow keys to select Dialysis


representation.

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Chapter 4: Operation

Press the Conf key.

Use the Arrow keys to select the individual


OCM parameters and set the desired values
by using the +/– or the 0–9 keys.
When entering V(urea), the fields for weight,
height, age and gender will be blank.
If V(urea) is not known, a value for V(urea) will
be calculated from the weight, height, age
and the gender.

Note
It is sufficient to enter the distribution volume of Vurea for the Kt/V
calculation. If V(urea) is not known, a value for V(urea) will be calculated
from the weight, height, age and the gender by means of an empirical
formula.
The maximum accuracy of the Kt/V calculation can only be obtained if
V(urea) is entered directly.
The hematocrit value (HCT) is used for calculating the plasma Na+. If
no value is entered, a fixed value will be used.

Press the Conf key.


The treatment starts with the online clearance
measurements.

Note
A cleaning program must be performed after each OCM treatment.

4.4.3.4 Entering or changing the OCM parameters

Use the Arrow keys to select Dialysis


representation.

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Chapter 4: Operation

Press the Conf key.

Use the Arrow keys to select the individual


OCM parameters and set the desired values
by using the +/– or the 0–9 keys.
When entering V(urea) , the fields for weight,
height, age and gender will be blank.
If V(urea) is not known, a value for V(urea) will
be calculated from the weight, height, age
and the gender.
The data fields are reset to the default values
by pressing the C key.

Press the Conf key.

4.4.3.5 Terminating / stopping Online Clearance Monitoring

Note
An OCM can be stopped by the operator via the item OCM OFF in the
Dialysis representation menu at any time. It can be reselected.
However, values for Kt/V will no longer be calculated.

Use the Arrow keys to select Dialysis


representation.

Press the Conf key.

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Chapter 4: Operation

Use the Arrow keys to select OCM.


Use the +/– keys to set OFF.

Press the Conf key.


The treatment will be continued without
Online Clearance Monitoring.

4.4.3.6 Display of the OCM parameters

Use the Arrow keys to select Dialysis


representation.

Press the Conf key.

Use the Arrow keys to select one of these


two diagrams:
– Upper Selection
– Lower Selection
Use the +/– keys to select the desired
diagram.
If the same diagram has been selected
for both display fields or if "0" (no
diagram) has been selected for one field
by pressing 0, the diagram selected will
be displayed in double size.

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Chapter 4: Operation

Press the Conf key.

 Parameters to be entered

Dry weight For the calculation of V(urea)


Height For the calculation of V(urea)
Age For the calculation of V(urea)
Gender For the calculation of V(urea)
V(urea) Entry in liters
HCT For the calculation of K and plasma-Na+
Msmt.Intv. Interval between two measurement cycles
Kt/V goal Dialysis dose prescribed by the physician

Note
We recommend entering V(urea). If V(urea) is not known, a value will be
calculated from the weight, height, age and the gender using the
formula developed by Watson. Alternatively V(urea) can be determined
in the laboratory from blood samples. The HCT value determined from
a blood sample prior to the treatment must be entered in the HCT field.

 Calculation of V(urea) using empirical formulas

The distribution volume of urea, V(urea) has to be determined for


calculating the dialysis dose Kt/V. In ideal conditions it is determined by
a clinical measurement with the patient. In many cases, however, this
value is not available. In this case empirical formulas are used to
determine V(urea) by means of gender, weight, height and age of the
patient:

Formula 1: Watson's Male patient: V(urea) = 2.447 – 0.095 • a + 0.107 • h + 0.336 • w


formula
Female patient: V(urea) = –2.097 + 0.107 • h + 0.247 • w
The variables stand for:

V: Total water volume of the body


(synonym for V(urea))
a: Age of the patient in years
h: Height in cm
w: Weight in kg

If the age of the patient is not known, the Hume-Weyers formula will be
used (only relevant for male patients; for female patients, the Watson's
formula will be used):

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Chapter 4: Operation

Formula 2: Male patient: V(urea) = –14.013 + 0.195 • h + 0.297 • w


Hume-Weyers formula

If the height of the patient is not known, V(urea) will be calculated


exclusively from the weight:

Formula 3 Male patient: V(urea) = 0.59 • w


Female patient: V(urea) = 0.53 • w
Instead of entering V(urea) directly, V(urea) can also be calculated by
means of empirical formulas using the patient-specific parameters
weight, height, age and gender.
The validity range of these formulae is restricted by the variation in
patient-related data. TValues for V(urea) which are outside the
plausibility range are therefore replaced by values calculated with a
simple standard formula.

Gender V(urea) plausibility range Standard formula

Male 0.4 • weight< V(urea) <0.7 • weight V(urea) = 0.59 • weight

Female 0.35 • weight< V(urea) <0.65 • weight V(urea) = 0.53 • weight

Note
For an exact determination of the dialysis dose (Kt/V), the distribution
volume V(urea) must be determined on the basis of chemical
measurements made in the laboratory and the result must be entered
directly. The formulae provided for the calculation by the device
(Watson, Hume-Weyers, weight) are used in clinical practice, but are
rules of thumb only, especially with regard to the fact that in the event
of concomitant diseases, such as vascular diseases or other severe
metabolic disorders, and in pediatric dialysis, it must be expected that
the accuracy will vary.

Note
Do not use the Hume-Weyers and the Watson formula for patients with
concomitant diseases affecting the expected volume of urea distribution
(e.g. amputation, severe arteriosclerosis, atypical shift of the adipose
tissue / muscle ratio).

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Chapter 4: Operation

 Default values, resolution and limits of the data fields

Data field Default values Min. value Max. value Resolution

Dry weight -.- kg 20 kg 299 kg up to 99.9 kg: 0.1 kg


100 kg and more: 1 kg

Height --- cm 100 cm 250 cm 1 cm

Age --- yrs. 16 yrs. 99 yrs. 1 yrs.

Gender f f m -

V(urea) -.- l 0.0 l 199 l up to 99.9 l: 0.1 l


100 l and more: 1 l

HCT 35 % 10 % 70 % 1%

Kt/V goal -.- 0.1 9.9 0.1

Msmt.Intv. 25 min 25 min 9h 47 min. 12.5 min

The data fields are reset to the default values by pressing the C key.

 Stopping Online Clearance Monitoring

An OCM can be stopped manually at any time by selecting the field


"OCM OFF" in theDialysis representation menu. It can be reselected
if the starting conditions are fulfilled. However, values for Kt/V will then
not be calculated anymore.
– The OCM measurement will be stopped automatically if: SN or SN-
Click-Clack has been selected (OCM parameters are retained in
memory for 15 minutes, within 15 minutes the OCM can be restarted
and continued)
– a power failure occurs with empty battery (OCM parameters are
erased, OCM can not be reselected while the treatment is in
progress)
The last measured values can be displayed after abortion via the
"Dialysis representation" menu for 15 minutes until the device is
turned off or the next program is selected. Then the values will be
erased.

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Chapter 4: Operation

 Stopping the single OCM measurement

The single OCM measurement in progress will be stopped if any of the


following conditions occurs:
– A blood alarm
– A bypass or water alarm (conductivity, temperature, water
deficiency)
– The optical detector senses light. Kt/V is displayed, if available.
– The UF goal is reached. Kt/V is displayed, if available.
– The UF rate is changed by the operator.
– The base conductivity is changed by the operator or changed
indirectly (by aborting the profile).
– The blood flow is < 80 ml/min or changed by the operator.
– The dialysate flow drops below 250 ml/min or the desired flow is
changed manually.
– The fill program is active.
– A CPHT occurs during the OCM measurement.
– A CPHT was not completed successfully. The waiting time since the
last OCM measurement has elapsed.
– Reinfusion has been selected.
– The operator changed a value in the dialysate menu (flow,
concentrate mixture, temperature).
If the OCM measurement pulse has not yet been started when the
condition causing the abortion occurs, the measurement will be
repeated at the next possible point in time.
If a single measurement in progress had to be aborted, the
measurement will only be repeated after 12.5 min if the pulse is
opposite to the previous pulse. Otherwise the operator has to wait until
the waiting time of 25 min has elapsed.

 No evaluation of the OCM measurement

Even if the CD variation was properly completed, it may be impossible


to evaluate the measurement which means that no values for the
measurement parameters Clearance, Kt/V or plasma Na+ can be
calculated. The measurement will then be repeated at the next possible
occasion.
Possible causes for rejecting measurements are for example:
– The ultrafiltration rate is higher than 15 % of the blood flow
– The effective blood flow is less than 80 ml/min
– Excessive arterial blood flow fluctuations
– Blood or dialysate alarms
– Power failure
– Change of the dialysate conductivity by the operator

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Chapter 4: Operation

 Stopping the Kt/V calculation

Kt/V calculation is stopped in the following situations:


– OCM stopped by the operator
– OCM is deactivated by the dialysis device due to a malfunction.
– No valid measurement within 80 min after the optical detector
sensed blood
– No valid value for V(urea) entered. In this case Kt will be calculated
instead of Kt/V.

 Deleting the OCM data

The OCM data will be deleted after selection and confirmation of a


cleaning program or of the menu option "Delete treatment
parameters".
If OCM is deactivated, the data will be deleted after 15 minutes.

 ISO-UF and OCM

No OCM measurements are performed during the ISO-UF treatment.


After ISO UF was completed and the first OCM measurement was
successfully performed, the Kt/V or Kt will be calculated by means of the
stored UF data via the ISO UF treatment. The OCM graphs will
therefore be displayed with some delay.

 Display messages

In addition to the already existing messages, the following OCM-


specific messages can be displayed:

Information messages
Clear.: XXXml/min Shows the current Na clearance value.
Displayed for one minute after each
successful measurement.
Plasma Na: XXXmmol/l Shows the plasma sodium concentration of
the last single measurement for 1 minute.
Kt/V: X.XX Shows the current Kt/V value. The value is
displayed for 1 minute if the UF goal has been
reached or the optical detector becomes light.
Kt: XX.Xl Is displayed instead of "Kt/V:X.XX" if no valid
value is available for V(urea). Shows the
current Kt value. The value is displayed for
1 minute if the UF goal has been reached or
the optical detector becomes light.
Kt/V: not available No Kt/V data are available as no successful
OCM measurement has been performed or
the calculation of Kt/V was aborted. The
value is displayed for 1 minute if the UF goal
has been reached or the optical detector
becomes light.

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Chapter 4: Operation

Enter V(urea) ? This message is displayed at the beginning of


a dialysis treatment if V(urea) has not been
entered by the operator. It will be displayed a
soon as the operator has manually turned on
OCM or after the optical detector detected
blood if "O.C. Measurement: ON" was
preselected in the SETUP. The message
prompts the operator to enter the urea
distribution volume of the patient and is only
displayed if V(urea) has not yet been entered.
If V(urea) is changed during the OCM
measurement, Kt/V will be recalculated,
provided it is already available. The message
is cleared after confirmation with the
Start/Reset key.
SN < > OCM OCM can not be started as a Single-Needle
treatment procedure (SN or SN-Click-Clack)
has been selected.
Profile < > OCM OCM can not be performed simultaneously
with a Na-/UF profile 1, 5, or 6 and a
treatment time of less than 180 min.
Displayed when OCM is turned on or when
selecting the profile.
OCM tech. deact./X OCM can not be started, as the CD cells or
the temperature sensors have not been
calibrated correctly or have been deactivated
while the device was operated. This message
will also be displayed if the integral relation of
the calibration measurement is outside the
limits. It is displayed when the OCM is
manually activated or when the optical
detector is dark if OCM is active due to the
default setting.
This message signals the operator that the
calibration of the OCM values has to be
performed.
The service technician must be informed of
the error code (X).
OCM off/X OCM was stopped due to an error or the
selection of SN-Click-Clack and will remain
deactivated until the end of the treatment.
The service technician must be informed of
the error code (X).
Input value too low The operator tried to enter a value which is
below the minimum limit for the OCM
parameters.
Input value too high The operator tried to enter a value which is
above the maximum limit for the OCM
parameters.

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Chapter 4: Operation

Warning
Kt/V too low This message will be displayed if the
prescribed Kt/V will not be reached at the end
of the treatment with the current Kt/V.

Information messages at
the beginning of the T1 test OCM T not calibrat Temperature not calibrated.
Repeat calibration.
OCM CD not calibrat Conductivity not calibrated.
Repeat calibration.
OCM COMP not calibr Temperature/conductivity compensation not
calibrated.
Repeat calibration.
OCM PULSE not calibr OCM pulse calibration not calibrated.
Repeat calibration.
OCM TECH. not OK OCM was technically deactivated during a
treatment.
Check the complete OCM calibration and
repeat it.

Note
If one of these messages is displayed at the beginning of the T1 test, it
will be possible to perform a treatment but the OCM function will remain
disabled.

4.4.3.7 OCM screen

1
2
3

9
10

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Chapter 4: Operation

1 Display of the OCM status and the OCM data The following fields are only used to display data.
2 Goal Kt/V shown in green. 7 Shows the Kt/V value reached up to the present
time.
3 Urea clearance K (blue)
If no valid value for V(urea) is available Kt will be
The diagram for Kt/V will be redrawn if V(urea) was
displayed (resolution 0.01 for Kt/V).
changed.
8 Remaining dialysis time until the prescribed
4 Dialysis dose Kt/V (red), cumulated up to time t.
dialysis dose will be reached.
If V(urea) has not been entered Kt (black)
cumulated up to the time t will be displayed. 9 Shows the plasma sodium concentration derived
from the last single measurement in mmol/l
5 The time axis for indicating the clearance or Kt/V or
(resolution 1 mmol/l).
Kt graphs has a yellow background. In contrast to
the time axis of all other diagrams coupled to the 10 Last measured Na-clearance value (resolution
UF time, the OCM time axis is independent and is 1 ml/min).
also updated if ultrafiltration is turned off.
11 The plasma Na value over UF time can be
6 Indication of the OCM status graphically displayed in the UF/Na diagram.

11

4.4.3.8 Conductivity limits during a measurement

If the conductivity limits are changed or centered during a


measurement, spreading of the limits will be stopped and the single
measurement currently in progress will be aborted.

Note
Make sure that the window is properly positioned.

The CD window will be spread up for a maximum of 220 seconds to up


to 17.5 % from the mean value of the conductivity window while a
measurement is in progress. It will, however, not exceed the
measurement range limits.

4.4.3.9 Changing the concentrate settings during a CD variation

The current desired conductivity should not be changed during the CD


variation as this would cause the measurement to be aborted and to be
repeated later.

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Chapter 4: Operation

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Chapter 5: Alarm processing

5 Alarm processing

5.1 Management of alarm limits

5.1.1 Centering the arterial / venous alarm limits

The arterial and/or venous alarm limits are


not centered.

Press the Start/Reset key.

New Limits?
Display message

Press the Start/Reset key again.


If the key is not pressed within approx.
8 seconds, the original alarm limits will
be retained.

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-1


Chapter 5: Alarm processing

The arterial alarm limits are centered around


the actual value.
Depending on the default set in the SETUP:
The venous alarm limits are positioned
symmetrically or asymmetrically around the
actual value.

5.1.2 Centering the TMP alarm limits

The TMP alarm limits are not centered.

Use the UF ON/OFF key to turn the


ultrafiltration off and on again.
This function is not available when
running a profile.

The TMP alarm limits are opened fully.

5-2 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 5: Alarm processing

The TMP alarm limits are centered around


the actual value.
(time delay depending on the UF
coefficient)

The position of the TMP alarm window may


automatically rise during the treatment.

5.1.3 Changing the arterial / venous / TMP alarm limits

Caution
It is important to set the lower venous alarm limit as close as possible to
the actual value of the venous pressure.

Caution
When the TMP alarm limits are adjusted by the operator, care must be
taken to select a window size as small as possible to ensure appropriate
protection.

Note
Automatic adaption of the window size is now deactivated.

Use the Arrow keys to select the Alarm


limits menu.
Press the Conf key.

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Chapter 5: Alarm processing

Use the Arrow keys to select the Position or


the Size field of the desired alarm limits.
Change the alarm limits with the +/– keys.
Press the Conf key.
The position of the TMP alarm window may
automatically rise during the treatment.

5.2 Needle adjustment

This function permits correction of the needle without false alarms. The arterial and venous alarm limits
are deactivated for 2 minutes. The full scale values and the lower venous alarm limit of 20 mmHg are still
active.

5.2.1 Start

Use the Arrow keys to select the Alarm


limits menu.
Press the Conf key.

Use the Arrow keys to select the Needle


Adj.Pgm field.
Use the +/– keys to set the needle adjustment
to ON.
Press the Conf key.

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Chapter 5: Alarm processing

Needle Adj. Pgm


Display message

Status indicator light turns yellow


(warning/info).

The arterial and venous alarm limits are


flashing.

5.2.2 Stop

Use the Arrow keys to select the Alarm


limits menu.
Press the Conf key.

Use the Arrow keys to select the Needle


Adj.Pgm field.
Use the +/– keys to set the needle adjustment
to OFF.
Press the Conf key.

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-5


Chapter 5: Alarm processing

5.3 Blood alarms

Caution
When overriding a safety system, the responsibility for the patient’s
safety rests with the operator of the device.

5.3.1 Indication of alarms

Status indicator light turns red (alarm).

The Start/Reset LED is flashing.


The Mute LED is flashing.
The blood pump(s) stop(s).
The venous clamp closes.
The UF pump is not running.
The nurse call is active.
Audible signal

Alarm
Upper ven. Alarm
Message: Alarm
e.g. Upper ven. Alarm

5.3.2 Arterial pressure alarm

Arterial Pressure alarm indicator is flashing.


Cause:
The arterial pressure is outside the alarm
limits.

5-6 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 5: Alarm processing

Alarm
Lower art. alarm
Message: Alarm
e.g. Lower art. alarm

Press the Start/Reset key.

new art limits?


Display message
The alarm limits are flashing for 8 seconds.
The alarm limits are inactive

Press the Start/Reset key again.


If the key is not pressed within approx.
8 seconds, the original alarm limits will
be retained.

The Start/Reset LED is illuminated.


The Mute LED is illuminated.

The arterial alarm limits are temporarily fully


open.

The arterial alarm limits are then centered


around the actual value.

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-7


Chapter 5: Alarm processing

5.3.3 Venous pressure alarm

Venous Pressure alarm indicator is flashing.


Cause:
The venous pressure is outside the alarm
limits.

Alarm
Upper ven. Alarm
Message: Alarm
e.g. Upper ven. Alarm

Press the Start/Reset key.


The Start/Reset LED is illuminated.
The Mute LED is illuminated.

new ven limits?


Display message

The alarm limits are flashing for 8 seconds.


The alarm limits are inactive

5-8 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 5: Alarm processing

Press the Start/Reset key again.


If the key is not pressed within approx.
8 seconds, the original alarm limits will
be retained.

The venous alarm limits are temporarily


opened fully.
The venous alarm limits are then centered
around the actual value.

5.3.4 TMP alarm

TMP alarm indicator is flashing.


Cause:
The TMP is outside the alarm limits.

Alarm
Upper TMP alarm
Message: Alarm
e.g. Upper TMP alarm

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-9


Chapter 5: Alarm processing

Press the Start/Reset key.


The Start/Reset LED is illuminated.
The Mute LED is illuminated.

new TMP limits?


Display message

The alarm limits are flashing for several


seconds depending on the calculated UFC.
The alarm limits are inactive

Press the Start/Reset key again.


If the key is not pressed within approx.
8 seconds, the original alarm limits will
be retained.

The TMP alarm limits are opened fully for


several seconds, depending on the
calculated UFC.
The TMP alarm limits are then centered
around the actual value.

5-10 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 5: Alarm processing

Caution
Sudden changes of the TMP are indicative of a problem.

5.3.5 Blood leak dimness warning

Warning
BLD-dimness-warning
Message: Warning
Causes:
– Dialysate side primed in dialysis mode.
– High deaeration caused by high
ultrafiltration rate.
– Dialysate outflow line not tightly
connected.
– Poor pre-deaeration – air bubbles in
dialysate inflow line.
– Grease or calcium precipitation.

Press the Start/Reset key (see


chapter 5.5.2, page 5-22).

In the event of grease and/or calcium


precipitation:
A disinfection program must be performed at
the end of the treatment.

5.3.6 Blood leak alarm

Blood Leak alarm indicator is flashing.


Cause:
Dialyzer membrane rupture.

Alarm
Blood Leak
Message: Alarm
Override with [Conf] key

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-11


Chapter 5: Alarm processing

Press the Conf key.

Bld. leak overridden


Display message
Override time: 2 minutes each time the key is
pressed.
The alarm indicator will stop flashing if the
leak seals.
If the blood leak persists, replace the dialyzer.

5.3.7 Blood pump alarm

Alarm
Bloodpump-stop
Message: Alarm message after
30 (15) seconds.

Rate: ml/h (Ø:ml) The Alarm (red) LED of the blood pump is
illuminated.
Start
Stop Error message of the blood pump
E.XX.

Rate: ml/h (Ø:ml) Press the Start/Stop key.

Start
Stop

Press the Start/Reset key.

5-12 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 5: Alarm processing

Note
If the problem persists, call the service.

5.3.8 Heparin pump alarm

Warning
Heparin pump alarm
Message: Warning

Rate: ml/h (Bolus:ml) The Alarm (red) LED of the heparin pump is
( :h.min)
Rate illuminated.
Bolus Start
Stop Error message on the heparin pump module
E.XX.

Press the Start/Reset key.

Note
If the problem persists, call the service.

5.3.9 Air detector alarm

Air Detector alarm indicator is flashing.


Cause:
Air or foam in the venous bubble catcher.

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-13


Chapter 5: Alarm processing

Press the  key to raise the level in the


venous bubble catcher.
The venous line clamp is closed, the
delivery rate of the blood pump is
reduced to 100 ml/min.

Press the Start/Reset key.

5.3.10 Blood pump stop alarm

Alarm
Bloodpump-stop
Message: Alarm

Rate: ml/h (Ø:ml) The Alarm (red) LED on the blood pump is
illuminated.
Start
Stop Cause:
The rotor stopped for more than
30 (15) seconds.

Press the Start/Reset key.

5-14 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 5: Alarm processing

5.3.11 Blood pump stop alarm in Single-Needle mode (option)

Alarm
Bloodpump-stop
Message: Alarm

Rate: ml/h (Ø:ml) Rate: ml/h (Ø:ml) The Alarm (red) LED is lit on the arterial
blood pump or the SN blood pump module.
Start
Stop
Start
Stop Cause: One of the blood pump rotors has
stopped.
The response time is determined by the
speed.

With the compliance chamber filled, press the


SN key.
The SN LED is dark.

Caution
Preventing contamination:
To prevent cross-contamination only use blood lines with hydrophobic
filters connected to the pressure lines. If a hydrophobic filter has
become wet, the blood lines must be replaced.
On blood lines with additional connection sites, a replacement pressure
measurement line may be connected (accessory available from
Fresenius Medical Care).
If the pressure measurement unit is contaminated, all affected parts
must be disinfected or replaced.

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-15


Chapter 5: Alarm processing

2 1. Remove the SN pump segment.


2. Disconnect the SN pressure measuring
line and connect it to a syringe.

Rate: ml/h (Ø:ml) Rate: ml/h (Ø:ml) Press the  key to reduce the blood pump
rate on the arterial blood pump.
Start Start
Stop Stop

Press the Start/Reset key.


The blood pump starts rotating.

5-16 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 5: Alarm processing

Use the syringe to drain the fluid from the


compliance chamber while the arterial blood
pump is running.

Rate: ml/h (Ø:ml) Rate: ml/h (Ø:ml) Use the Start/Stop key to stop the arterial
blood pump.
Start
Stop
Start
Stop The Operation (green) LED is dark.

1. Clamp the SN pressure measuring line


before the hydrophobic filter.
2. Connect the single pressure
measurement line to an additional
1 connection point.

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-17


Chapter 5: Alarm processing

1. Connect the SN pressure measurement


line to the white SN Luer-lock.
2. Insert the SN pump segment.
1

Press the SN key.


The SN LED is illuminated.

Rate: ml/h (Ø:ml) Rate: ml/h (Ø:ml) Press the  key and the  key to set a new
blood pump rate on the arterial blood pump.
Start
Stop
Start
Stop Use the Start/Stop key to start the arterial
blood pump.
The Operation (green) LED is illuminated.

Press the Start/Reset key.


The Start/Reset LED is illuminated.
The Mute LED is dark.

5.3.12 Cycle alarm in Single-Needle Click-Clack mode

Alarm
Cycle alarm
Message: Alarm

5-18 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 5: Alarm processing

Venous Pressure alarm indicator is flashing.


Cause:
Cycle time (approx. 15 seconds) exceeded.

Press the Start/Reset key.


The Start/Reset LED is illuminated.
The Mute LED is dark.

5.4 Dialysate alarms

5.4.1 Indication of alarms

Status indicator light turns red (alarm).

The Mute LED is flashing.


The nurse call is active.
Audible signal
The alarm message and the effect of the
alarm are automatically reset when the
problem causing the alarm has been
corrected. The audible alarm can be
suppressed for 1 minute by pressing the
Mute key (factory setting).
The Flow LED is flashing: Bypass

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-19


Chapter 5: Alarm processing

5.4.2 Conductivity alarm

The Conductivity alarm indicator is


illuminated.
The Flow LED is flashing, bypass operation.
Cause:
The actual conductivity value is outside the
alarm limits.
Remedy:
Verify the concentrate.
Correct the problem causing the alarm.

5.4.3 Temperature alarm

Warning
Upper temp. alarm
Message: Warning
The Flow LED is flashing, bypass operation.
Cause:
or
The actual temperature is outside the alarm
Warning limits.
Lower temp. alarm
Remedy:
Wait for the temperature to reach the desired
value or call the service.

5.4.4 Flow alarm

Warning
Flow alarm
Message: Warning
Cause:
– Line to or from dialyzer or drain line are
kinked.
– Defect in hydraulics.
Remedy:
Check the lines.
Call the service.

5-20 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 5: Alarm processing

Warning
Flow alarm
Message: Warning
Press the [Conf] key to confirm
Cause:
The actual dialysate flow falls below the
preset value by more than 20 %
Remedy:
Check the lines.
Press the Conf key.
Call the service.

Note
The operator can decide if the treatment should be continued with the
reduced flow.

Warning
Water alarm
Message: Warning
The Flow LED is flashing, bypass operation.
Cause:
Water supply problem.
Remedy:
Check the water supply.
Call the service.

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-21


Chapter 5: Alarm processing

5.5 Warnings

5.5.1 Indication of warnings

Messages will be displayed in the text field or in a pop-up window. The messages are either warnings or
information messages.

Example:

Warning
Wrong conc. supply
Message: Warning
Blood and dialysate are active.

5.5.2 Warnings / information messages

Message Cause Possible solution First Repetition


warning

24 V Switched Off The watchdog relay has Use the On/Off key to turn – –
been switched off. the device off and on
again.
Call the service.

ASP failure ! Air separation pump has Acknowledge by pressing – –


been active for more than Start/Reset.
60 seconds without
interruption.

BIBAG cover open bibag®Connector open Close the bibag® – –


although bibag® operation connector.
is not possible

BLD-dimness-warning Blood leak detector Acknowledge by pressing – –


contaminated or large Start/Reset.
amounts of air in the
Perform a cleaning
dialysate system.
program.
See also message
Fillprogram.

CPU-II failed System error Use the On/Off key to turn – –


the device off and on
again.
Call the service.

Dialines not conn The dialysate couplings Connect the couplings to approx. –
are still in the shunt the dialyzer. 9 min
interlock.

5-22 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 5: Alarm processing

Message Cause Possible solution First Repetition


warning

Dialysate lines not The dialysate couplings Insert the dialysate – –


connected are not in the shunt couplings into the shunt
interlock. interlock and wait for
3 min.

Wrong conc. supply Incorrect concentrate Verify the concentrate – –


composition. side.

Error on the RCU! Incorrect information of Press the Start/Reset – –


the remote control. key.
Call the service.

Hep.-Modul error EXX Communication between Press the Start/Reset key – –


heparin pump and monitor (see chapter 5.3.8,
interrupted. page 5-13).
Heparinization will be
continued without stop
time.

Flow - off warning The dialysate flow was Press the Start/Reset key 30 min 30 min
turned off. (if no flow is desired at the 45 min 45 min
moment) or turn the 60 min 60 min
dialysate flow on. (SETUP) (SETUP)

Fillprogram Air in dialysate system Automatic air separation, – –


TMP limits are flashing acknowledge Fillprogram
and inactive. end by pressing the Start/
Reset key.
If the message is
displayed frequently or
permanently, stop the
dialysis and call the
service.
If it is not observed, a
balancing error (wrong UF
volume) may occur.

Funct. not allowed Is always displayed if a Observe the operating – –


function is not possible. sequence.

FXXX UF failure UF pump or control Press the Start/Reset – –


defective. key.
Call the service.

Heparin pump not on Heparin pump is not Press the Start/Reset approx. –
turned on. key (no heparinization) or 11 min
turn the heparin pump on.

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-23


Chapter 5: Alarm processing

Message Cause Possible solution First Repetition


warning

Heparin pump alarm Heparin syringe reached Heparinization no longer – –


the end position. required:
Press the Start/Reset
key.
Insert a new syringe: (see
chapter 4.1.7.1,
page 4-21)

Heparin pump error Press the Start/Reset key – –


(see chapter 5.3.8,
page 5-13).

NO - UF Ultrafiltration is off. Press the Start/Reset key 10 min 10 min or


(if no UF is desired at the or 30 min
moment) or turn 30 min (SETUP)
ultrafiltration on by (SETUP)
pressing the UF ON/OFF
key.

Connect Conc.Line No concentrate Verify the concentrate – –


connected. side.

Check Concentrate! Concentrate container Connect a new – –


empty concentrate container.
The message will be
cleared automatically.

Shunt Cover open The shunt interlock has Close the shunt interlock. 1 min –
been opened.

Air in system Air in dialysate system Turn the flow on. – –


With ISO-UF:
Turn UF off, then turn ISO-
UF off.

MODULE Error Malfunction in hydraulic Call the service. – –


processing unit.

Profiles paused Profiles have been Restart the profiles or 10 min 10 min
stopped. keep them stopped by
pressing the Start/Reset
key.

Profile time diff. Difference between UF Press the Start/Reset key – –


time and profile time. or stop the profile.
Call the service.

Voltage Failure One of the voltages is Use the On/Off key to turn – –
outside the alarm limits the device off and on
(+5 V, +12 V, +24 V) again.
Call the service.

5-24 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 5: Alarm processing

Message Cause Possible solution First Repetition


warning

RCU Keyboard Error Incorrect information of Press the Start/Reset – –


the remote control. key.
Call the service.

Timer "Alarm" The time has elapsed. Press the Start/Reset – –


key.

Timer stops UF rate The UF time has elapsed. Press the Start/Reset – –
key.
The UF pump is not
running.

set UF rate The UF goal can not be Turn the UF unit off. – –
reached with the Adjust the UF parameters
remaining UF time and the (e.g. UF rate).
UF rate set.

UF goal reached UF time elapsed and UF Press the Start/Reset – –


goal reached. The UF key.
pump is not running.

UF parameters? The UF data were not Use the Conf key to – –


entered completely. acknowledge.
Press the [Conf] key to
confirm Correct the UF data, if
necessary.
Start UF.

V84 faultiness ! Malfunction of valve V84. Use the Start/Reset key – –


to acknowledge.
Stop the treatment
because of a possible
balancing error.
Perform a disinfection
(cleaning program 1 to 4).
If the problem recurs, call
the service.

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-25


Chapter 5: Alarm processing

Message Cause Possible solution First Repetition


warning

Relation BPR/UFR ? The ultrafiltration rate is Press the Start/Reset 2 min 30 min
too high in relation to the key.
delivery rate of the blood
Reduce the ultrafiltration
pump.
rate or increase the blood
pump rate.

Cyclic PHT FXX Leakage in the balancing Use the Start/Reset key approx. approx.
system during dialysis to acknowledge, knowing 13 min 3 min
Caution! Balancing error
operation. that a balancing error may
possible!
occur.
Bypass operation UF off
If the test is not passed
again stop the treatment
and call the service.
If this is not observed, a
balancing error may
occur.

Cyclic PHT F04 Blood leak alarm Use the Start/Reset key approx. approx.
persisted for more than to acknowledge, knowing 15 min 6 min
Caution! Balancing error
3 minutes. that a balancing error may
possible!
occur.
or
If the test is not passed
The cyclic pressure
again stop the treatment
holding test could not be
and call the service.
performed (system error).
If this is not observed, a
balancing error may
occur.

5.6 Power failure

Status indicator light turns red (alarm).


Audible signal
The nurse call is active.
The hydraulics are off.
The UF pump is not running.
The extracorporeal blood circuit is
maintained.

Power Failure
Display message

5-26 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 5: Alarm processing

The Start/Reset LED is illuminated.


The Mute LED is flashing.

Press the Mute key.


Status indicator light turns green (operation).
The Start/Reset LED is illuminated.
The Mute LED turns dark.
No audible signal.
In the event of a prolonged power failure,
treatment must be discontinued.
The treatment will continue as programed as
soon as the power resumes.

Caution
In the event of a prolonged power failure, use the hand crank to
manually return the blood to the patient. For manual reinfusion, remove
the venous patient line from the venous line clamp. Visually check the
line for air!
In Single-Needle mode, also remove the BP segment for the BP (SN)
from the blood pump!

5.7 Error messages during cleaning programs

5.7.1 Indication of errors

Indication of errors during cleaning programs:


Status indicator light turns red (alarm).

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-27


Chapter 5: Alarm processing

Message: Alarm or Warning


The Cleaning LED is flashing.
The Mute LED is flashing.
The dialysate circuit is inactive.
Audible signal

5.7.2 Error messages

Message Cause Possible solution

Arterial pressure ? The arterial pressure is outside the Check the blood line.
alarm limits.
(only while priming/ Connect the blood line.
precirculation during
Purge the hydrophobic filter.
cleaning programs)
Increase the blood pump speed
(>100 ml/min).
Call the service.

Bic line not connected Bicarbonate connector is not positioned Place the bicarbonate connector in the
in the rinse chamber. rinse chamber.

Please Wait Sucking in the disinfectant via the cleared automatically


concentrate pump.

Bypass Valve failed Actual status of the bypass valve Can be acknowledged by pressing the
(on/off) does not agree with the desired respective cleaning program key.
status.
Call the service.

CPU-II failed System error Use the On/Off key to turn the device
off and on again.
Call the service.

5-28 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 5: Alarm processing

Message Cause Possible solution

Disinfectant empty? The float switch fails to detect fluid. Check the disinfectant container.
Sensor of disinfectant valve 115 fails to Use the Cleaning key to acknowledge.
detect conductivity.
Call the service.
The level sensor/concentrate fails to
detect fluid.

Connect Disinfectant No disinfectant connected. Connect a disinfectant.


Message: Press CONFIRM Key.
Press the Conf key.

Disinf-Temp. to high Temperature after rinsing higher than The rinsing procedure will be continued
40 °C. until the temperature is < 40 °C.
Cleared automatically.
Call the service.

Dial. Valve failed Actual status of the dialyzer valves Can be acknowledged by pressing the
(on/off) does not agree with the desired respective cleaning program key.
status.
Call the service.

F. pos. Pressure Pressure transducer 9 fails to detect a The error can not be corrected in the
pressure build-up. cleaning program (precirculation not
(only while priming/
possible). After cleaning: Perform a T1-
precirculation during
Test. Call the service.
cleaning programs)

Level Detect. failed Air detector test failed. The error can not be corrected in the
cleaning program (precirculation not
(only while priming/
possible). After cleaning: Perform a T1-
precirculation during
Test. Call the service.
cleaning programs)

Opt. Detector failed Optical detector test failed. The error can not be corrected in the
cleaning program (precirculation not
(only while priming/
possible). After cleaning: Perform a T1-
precirculation during
Test. Call the service.
cleaning programs)

Filter change! Error detected during the T1 test. Select an other cleaning program or
(Pressure holding test failed.) perform a filter change (see
chapter 4.4.1.4, page 4-81).
Maximum filter life after installation
exceeded. If the filter is not changed it will not be
possible anymore to perform a
Maximum number of permissible
treatment.
Sporotal disinfections reached.

Flow alarm Dialyzer lines kinked. Check the lines.


Cleared automatically.
Call the service.

Rinse Failure F01 V84 error Use the Cleaning key to acknowledge.
Rinse Failure F03 Call the service.

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-29


Chapter 5: Alarm processing

Message Cause Possible solution

Rinse Failure F02 V84 error Use the On/Off key to turn the device
off and on again.
Call the service.

In disinfection program (PGM 5): In disinfection program (PGM 5):


The level sensor/concentrate fails to Connect a cleaning agent.
detect fluid.

Rinse Failure FXX Error during the cleaning program Use the On/Off key to turn the device
off and on again.
Call the service.

Rinse Failure F07 Pressure drop on PSW 124. Call the service.

This error message may be indicated alternately with the message DO NOT
SWITCH OFF !!
Wait for 1 minute before turning the device off!

Rinse Failure F08 Pressure drop on PSW 123. Call the service.

This error message may be indicated alternately with the message DO NOT
SWITCH OFF !!
Wait for 1 minute before turning the device off!

Rinse Failure F21 Maximum number of strokes for Use the On/Off key to turn the device
sucking the disinfectant exceeded. off and on again.
Change the disinfectant container.
Call the service.

Internal Error XXX Runtime error in the program. Use the On/Off key to turn the device
off and on again.
Call the service.

Conc. detected F01 Bicarbonate level sensor (204) Start a disinfection program after
shunted. rinse/hot rinse.
Call the service.

Conc. detected F02 Concentrate level sensor (202) Start a disinfection program after
shunted. rinse/hot rinse.
Call the service.

Conc. detected F03 Bicarbonate level sensor (204) and Start a disinfection program after
concentrate level sensor (202) rinse/hot rinse.
shunted.
Call the service.

Conc line not connected Concentrate connector is not Place the concentrate connector in the
positioned in the rinse chamber. rinse chamber.

5-30 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 5: Alarm processing

Message Cause Possible solution

Shunt Cover defect Dialyzer lines connected to dialyzer Change the lines.
alternating with although the hemodialysis device is in
Check the dialyzer couplings.
Change blood lines! the cleaning mode.
Check the shunt interlock.
(only while priming/
precirculation during (If cleaning is possible without both
cleaning programs) dialyzer couplings being connected to
the shunt interlock:
Call the service).

Power Failure Power failure during operation. The respective program can be
continued after power return.

Upper Flow Alarm Cleaning flow increases to more than Can be acknowledged by pressing the
1000 ml/min. respective cleaning program key.
Call the service.

Blood sensed by OD The optical detector senses dark when Check the optical detector.
a cleaning program is started.
Call the service.

Float-Switch Failure The lower changeover point is not Can be acknowledged by pressing the
reached. respective cleaning program key.
Call the service.

Voltage Failure One of the voltages is outside the alarm Can be acknowledged by pressing the
limits (+12 V, +24 V). respective cleaning program key.
Use the On/Off key to turn the device
off and on again.
Call the service.

Rinse required! The mandatory rinse was stopped. Select the rinse program.

High temperature Temperature > 41 °C Call the service.


during hot rinse:
Temperature > 90 °C.

Low temperature Temperature < 33 °C Call the service.


during hot rinse:
Temperature < 78.5 °C.

UF pump failed The actual rate of the UF pump does Can be acknowledged by pressing the
not agree with the prescribed rate. respective cleaning program key.
Call the service.

V39 Failure V39 malfunction Call the service.

V91/V100 Failure The valve does not open. Call the service.

V99 Failure The valve does not open. Call the service.

V102 Failure V102 electrically opened. Call the service.

V104 Failure V104 electrically opened. Call the service.

V130 Failure V130 malfunction. Call the service.

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-31


Chapter 5: Alarm processing

Message Cause Possible solution

V188 Failure V188 malfunction. Call the service.

Venous pressure ? The venous pressure is outside the Check the blood line.
(only while priming/ alarm limits.
Connect the blood line.
precirculation during
cleaning programs) Purge the hydrophobic filter.
Increase the blood pump speed
(>100 ml/min).
Call the service.

Water alarm Float switch for t > 10 s low. Check the water supply.
Cleared automatically.
Call the service.

Water alarm Float switch for t > 30 s high. Cleared automatically.


Call the service.

5.8 Error messages after turning power on

Audible signal
Possible solution:
Call the service.
Bios Test passed
ROM Test passed
RAM Test passed

Message Cause Possible solution

FXX Configuration Incorrect system configuration. Call the service.

5-32 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 5: Alarm processing

Message Cause Possible solution

Keyboard Error Key on the monitor pressed when Use the On/Off key to turn the device
turning power on. off and on again.
Short-circuit on the keyboard. Call the service.

Watchdog Error This error message may only appear Use the On/Off key to turn the device
shortly after turning power on. off and on again.
Call the service.

HPU Error EXX Malfunction in hydraulic processing Use the On/Off key to turn the device
unit. off and on again.
Call the service.

5.9 Error messages when using the download function

Message Cause Possible solution

Download Error F001 Optical detector does not sense clear Ensure basic requirements are fulfilled.
fluid.
Restart data transfer.

Download Error F002 Data transfer not permitted or not Call the service.
possible.
(DIP switch 1 LP763 set to OFF)

Download Error F003 Patient key not inserted. Connect the patient key.
Restart data transfer, if desired.

Download Error F004 CRC check of communication not Call the service.
active.

Download Error F005 Received data record has an incorrect Call the service.
format (comma position).

Download Error F006 UF unit turned on during data transfer Turn the UF unit off.
Restart data transfer.

Download Error F007 Not in Preparation mode. Ensure basic requirements are fulfilled.
Restart data transfer.

Download Error F008 Unacceptable patient name Enter the patient name.
(19 blanks).
Restart data transfer.

Download Error F009 Value range of the UF parameter Check external data.
exceeded.
Restart data transfer.

Download Error F010 Non-uniform profile numbers Check external data.


(UF profile/Na+ profile).
Restart data transfer.

Fresenius Medical Care 4008 S OP-EN 4/12.10 5-33


Chapter 5: Alarm processing

Message Cause Possible solution

Download Error F011 UF or Na+ profile number not Check external data.
admissible.
Restart data transfer.

Download Error F012 Unacceptable dialysate flow. Check external data.


Restart data transfer.

Download Error F013 Base Na+ or prescribed Na+ value Check external data.
exceeded or limits preset in the SETUP
Restart data transfer.
exceeded.

Download Error F014 Start Na+ value exceeded. Check external data.
Restart data transfer.

Download Error F015 Bicarbonate value exceeded. Check external data.


Restart data transfer.

Download Error F016 Temperature not acceptable. Check external data.


Restart data transfer.

Download Error F018 Plausibility of UF rate, UF goal, UF Check external data.


time.
Restart data transfer.

Download Error F019 Plausibility check or Start Na+ value Check external data.
exceeded.
Restart data transfer.

Download Error F020 Block check of UF rate, UF goal, UF Check external data.
time, UF profile. Na+ profile, Base Na+,
Restart data transfer.
prescribed Na+, Start Na+.

Download Error F021 UF profile data plausibility. Check external data.


Restart data transfer.

Download Error F022 Na+ profile data plausibility. Check external data.
Restart data transfer.

Download Error F023 Invalid CRC of the patient key. Check patient key.
Restart data transfer.

Download Error F024 A further data record is received during Restart data transfer.
the confirmation procedure.

Download Error F025 Invalid CRC of the downloaded data Check external data.
record.
Restart data transfer.

5-34 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 6: Cleaning / disinfection

6 Cleaning / disinfection

6.1 General overview

Display message
(during the cleaning program)

–R–*1

–F–HR–C–
–F–HR–
–IHR–*2

–F–D–M–
–F–HDIS–M–
–F–D–M–HR–
–F–HDIS–M–HR–
–F–D(F)–M–
Display of still possible disinfections

Filter change program

Indication of date, time and program


for the last completed disinfection (arrow)

*1 Choose Rinse or Rinse endless using the +/– keys.


*2 Choose Integrated hot rinse or Integrated hot rinse with
cooling rinse using the keys +/–.
The part of the cleaning program currently in progress is displayed as
follows: > < (e.g. >F<HDIS–M–, rinsing clean in progress).

Fresenius Medical Care 4008 S OP-EN 4/12.10 6-1


Chapter 6: Cleaning / disinfection

 Explanation of abbreviations used

R Rinse

R endless Rinse endless

F Free rinsing

HR Hot rinse

C Cooling rinse

D Disinfection

D(F) Cleaning
Disinfectant is drawn in from the front (concentrate
suction tube)!

HDIS Hot disinfection

M Mandatory rinse

IHR Integrated hot rinse

6.1.1 General notes

Note
The count-down times shown during the cleaning programs are
calculated values. This time may vary depending on the ambient
conditions.

Note
Only applicable for devices with DIASAFE® plus:
When pressing the Cleaning key it will be displayed in the Cleaning
menu when the filter needs to be changed (see chapter 4.4.1,
page 4-79).

6-2 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 6: Cleaning / disinfection

Caution
Cleaning programs in progress involve the following risks:
– Hot rinse (risk of scalding)
– Hot disinfection (risk of scalding and caustic burning)
– Disinfection (caustic burning)
These risks are particularly present on the following accessible machine
parts:
– Concentrate and bicarbonate flap
– Dialysate lines and dialysate connectors
– Vent tubings (on the rear of the device)
– Water drains
– DIASAFE® plus
These risks can be present as long as the respective cleaning program
has not yet been completed.

6.2 External cleaning

After the treatment, the exterior of the hemodialysis device and the
options used must be cleaned with a cleaning and disinfecting agent.
Do not use any sharp objects for cleaning.

 Regular cleaning

Note
The following components have to be cleaned regularly:
– The dialyzer couplings and the shunt interlock
– The sealing area of the bibag® connector
– The sealing area of the concentrate suction tubes (concentrate /
bicarbonate)

Caution
After the components mentioned above were cleaned, a disinfection
has to be performed.

6.3 Basic conditions for cleaning programs

– The dialysate lines are connected to the shunt interlock.


– The shunt interlock is closed.
– The concentrate suction tubes are in the appropriate rinse ports.
– The bibag® connector flap is closed.

Fresenius Medical Care 4008 S OP-EN 4/12.10 6-3


Chapter 6: Cleaning / disinfection

– The optical detector does not sense blood.


Any failure to comply with the basic conditions will be indicated by a
message on the display.
All treatment data will be erased when selecting a cleaning program.

Caution
Contact of the DIASAFE® plus with organic solvents can affect the
properties of the material of housing, seals and capillaries. Safe
function can then no longer be ensured and the manufacturer shall no
longer have any liability. (See package insert DIASAFE® plus.)

6.4 Disinfection, decalcification

Factory setting is Citrosteril® or Diasteril®. For use of a different


disinfectant, this setting must be changed by a technician.

Caution
Hot water or steam may be released via the vent during the hot
disinfection.

Caution
Only applicable for DIASAFE® plus:
High surface temperatures on the DIASAFE® plus during the hot
disinfection.

6.4.1 Start

Press the Cleaning key.

6-4 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 6: Cleaning / disinfection

Use the Arrow keys to select the desired


disinfection program.
e.g. Hot disinfection

Press the Conf key.

6.4.2 Sequence

On-line display of the cleaning program in


progress.
Display message e.g. >F<HDIS–M–

The Cleaning LED is illuminated.


Status indicator light turns yellow
(warning/info).

The end of the program is indicated by an


audible signal and a flashing Mute LED.
Selectable in SETUP.

Status indicator light turns red (alarm).

Caution
A check for residual disinfectant on the drain line of the hemodialysis
device is always recommended. In case other test methods are applied,
the operator bears the responsibility of this decision.

Fresenius Medical Care 4008 S OP-EN 4/12.10 6-5


Chapter 6: Cleaning / disinfection

Caution
In case of disinfection with Puristeril® 340 or Puristeril® plus, the device
must be checked for residual disinfectant after termination of the
mandatory rinse program (e.g. potassium iodide starch paper).
If the test shows a residual concentration, the respective rinse program
must be repeated (it is, however, not necessary in this case to perform
the complete program).

Caution
After a disinfection with Diasteril®, the following must be observed: After
termination of the rinse program (mandatory rinse), the hemodialysis
device must be checked for residual disinfectant using the pH test. If the
pH is too high (color change, pH less than 4.1), run a rinse program for
a minimum of 5 minutes. Then perform a further test to determine the
pH.

6.4.3 Stopping the program

Caution
Do not stop a disinfection program before its completion. Premature
termination will compromise the efficacy of the disinfection.

Press the Cleaning key.

Info message
Terminate Info message
cleaning pgm?
(Press [Conf] to stop)

Press the Conf key.

6-6 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 6: Cleaning / disinfection

>F<HDIS–M–
Alternating display messages
Mandatory rinse end Audible signal
The Mute LED is flashing.
Status indicator light turns red (alarm).

Note
If the mandatory rinse program is stopped, the mandatory rinse time will
restart from the beginning.

Disinfection programs can also be stopped by


turning the concentrate or the bicarbonate
suction tubes.

Note
Do not remove the concentrate and bicarbonate suction tubes from their
ports to prevent leakage of fluid which might then enter inside the
device.

6.5 Cleaning / degreasing program

In this cleaning program the cleaning agent (Sporotal® 100) is drawn in


from the front via the concentrate suction tube.
The use of cleaning agents with another composition may cause the
message Disinfectant empty ? to be displayed, although the container
is full.

Note
Only applicable for DIASAFE® plus:
After installation, the DIASAFE® plus can be cleaned with
Sporotal® 100 for a maximum of 11 times.
The cleaning process using Sporotal® 100 is monitored by the
hemodialysis device (see chapter 4.4.1, page 4-79).

Fresenius Medical Care 4008 S OP-EN 4/12.10 6-7


Chapter 6: Cleaning / disinfection

6.5.1 Start

Press the Cleaning key.

Use the Arrow keys to select Cleaning


(front supplied).
Press the Conf key.

Free rinsing
The Cleaning LED is illuminated.
Status indicator light turns yellow
(warning/info).

Warning
Connect Disinfectant
Message: Warning
Audible signal
The Mute LED is flashing.
Status indicator light turns red (alarm).

6-8 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 6: Cleaning / disinfection

Place the red concentrate suction tube into


the container with the cleaning agent
(Sporotal® 100).
Press the Conf key.

Caution
Make sure that the container used contains sufficient cleaning agent to
complete the rinse program.
Avoid aspiration of air.

Warning
Please Wait
Message: Warning
Status indicator light turns yellow
(warning/info).
Cleaning agent is drawn in.

Warning
Conc line not connected
Message: Warning
Audible signal
The Mute LED is flashing.
Status indicator light turns red (alarm).
Place the red concentrate suction tube in the
rinse port.

6.5.2 Sequence

On-line display of the cleaning program in


progress.
Display message: –F>D(F)<M–

The Cleaning LED is illuminated.


Status indicator light turns yellow
(warning/info).

Fresenius Medical Care 4008 S OP-EN 4/12.10 6-9


Chapter 6: Cleaning / disinfection

The end of the program is indicated by an


audible signal and a flashing Mute LED.
Selectable in SETUP.

Status indicator light turns red (alarm).

Caution
A check for residual disinfectant on the drain line of the hemodialysis
device is always recommended.
In case other test methods are applied, the operator bears the
responsibility of this decision.

Caution
Check the device for residual disinfectant (e.g. with potassium iodide
paper).
If the test shows a residual concentration, the respective rinse program
must be repeated (it is, however, not necessary in this case to perform
the complete program).

6.5.3 Stopping the program

(see chapter 6.4.3, page 6-6)

6.6 Hot rinse

6.6.1 Start

Caution
Hot water or steam may be released via the vent during the hot rinse.

Caution
Only applicable for DIASAFE® plus:
High surface temperatures on the DIASAFE® plus during the hot rinse.

6-10 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 6: Cleaning / disinfection

Press the Cleaning key.

Use the Arrow keys to select the desired hot


rinse program.
e.g. Hot rinse

Press the Conf key.

6.6.2 Sequence

On-line display of the cleaning program in


progress.
Display message e.g. >F<HR–C–

The Cleaning LED is illuminated.


Status indicator light turns yellow
(warning/info).

Fresenius Medical Care 4008 S OP-EN 4/12.10 6-11


Chapter 6: Cleaning / disinfection

The end of the program is indicated by an


audible signal and a flashing Mute LED.
Selectable in SETUP.

Status indicator light turns red (alarm).

6.6.3 Stopping the program

Press the Cleaning key.

Info message
Terminate Info message
cleaning pgm?
(Press [Conf] to stop)

Press the Conf key.

>F<HR–C–
Alternating display messages
Free rinse end Audible signal
The Mute LED is flashing.
Status indicator light turns red (alarm).

6-12 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 6: Cleaning / disinfection

Cleaning programs can also be stopped by


turning the concentrate or bicarbonate
suction tube.

Note
Do not remove the concentrate and bicarbonate suction tubes from their
ports to prevent leakage of fluid which might then enter inside the
device.

6.7 Rinse

6.7.1 Start

Press the Cleaning key.

Use the Arrow keys to select the rinse


program.
Choose Rinse or Rinse endless using the
+/– keys.
Press the Conf key.

Fresenius Medical Care 4008 S OP-EN 4/12.10 6-13


Chapter 6: Cleaning / disinfection

6.7.2 Sequence

On-line display of the cleaning program in


progress.
Display message: >R<

The Cleaning LED is illuminated.


Status indicator light turns yellow
(warning/info).

The end of the program is indicated by an


audible signal and a flashing Mute LED.
Selectable in SETUP

Status indicator light turns red (alarm).

6.7.3 Stopping the program

Press the Cleaning key.

Info message
Terminate Info message
cleaning pgm?
(Press [Conf] to stop)

6-14 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 6: Cleaning / disinfection

Press the Conf key.

>R<
Alternating display messages
Please Wait approx. 20 seconds

>R<
Alternating display messages
Rinse end Audible signal
The Mute LED is flashing.
Status indicator light turns red (alarm).

Rinse programs can also be stopped by


turning the concentrate or bicarbonate
suction tube.

Note
Do not remove the concentrate and bicarbonate suction tubes from their
ports to prevent leakage of fluid which might then enter inside the
device.

6.8 Priming during cleaning programs

6.8.1 Basic conditions

Press the Cleaning key.

Fresenius Medical Care 4008 S OP-EN 4/12.10 6-15


Chapter 6: Cleaning / disinfection

Use the Arrow keys to select the desired


program.
e.g. Rinse

Press the Conf key.

6.8.2 Starting the program

Press the Prime key for 1 second.


The Prime LED is illuminated.

Status indicator light turns yellow


(warning/info).

Prime
Message displayed briefly

Rinse-volume: xxxx ml
If a rinse volume has been defined in the
SETUP:
Message displayed briefly

>R<
Display message e.g. >R<

6-16 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 6: Cleaning / disinfection

6.8.3 Setting the blood pump rate

Rate: ml/h (Ø:ml) The Operation (green) LED is illuminated.


Blood pump is rotating.
Start
Stop
The arterial blood pump fills the blood line up
to the venous bubble catcher.
A delivery rate > 100 ml/min will
automatically be reset to 100 ml/min.
The delivery rate can be changed by the
operator as desired.

Use the key  or the key  to select the


desired delivery rate.
(Pressing the key for more than
> 3 seconds: will accelerate the change
rate.)

6.8.4 Delivery stops

The blood pump stops as soon as the venous


bubble catcher is filled or after 1 to 5 minutes
at the latest.
Depending on the setting defined in the
SETUP.

or

Rinse-volume reached
Display message
If a rinse volume has been defined in the
SETUP.

Status indicator light turns red (alarm) for 2


seconds.

>R<
Display message

The Cleaning LED is illuminated.


Audible signal
cleared automatically after 2 seconds.

Fresenius Medical Care 4008 S OP-EN 4/12.10 6-17


Chapter 6: Cleaning / disinfection

It may be necessary to raise the level in the


venous bubble catcher.
Press the  key to set the desired level.

6.8.5 Interrupting the priming program

Rate: ml/h (Ø:ml) Press the Start/Stop key.


The Operation (green) LED turns dark.
Start
Stop
Continue by pressing the key again.

6.8.6 Premature termination

Press the Prime key for 1 second.


Press the Prime key a second time to
continue priming.

6-18 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 6: Cleaning / disinfection

6.8.7 Errors

The Prime LED is flashing.


Press the Prime key.
An error message displays in the status
line (see chapter 5.7, page 5-27).

6.9 Precirculation during the cleaning programs

6.9.1 Basic conditions

A cleaning program has been selected.


Priming has been started with the Prime key.

Note
The dialysate couplings must be in the shunt interlock.

Fresenius Medical Care 4008 S OP-EN 4/12.10 6-19


Chapter 6: Cleaning / disinfection

6.9.2 Preselection

Press the Start/Reset key for 1 second.


The Prime LED is illuminated.

Status indicator light turns yellow


(warning/info).

Prime/Circulation
Message displayed briefly
Precirculation will be started automatically
after priming has been completed.

>R<
Display message e.g. >R<

6.9.3 Start

Priming has been completed.


The blood pump stops, the venous
bubble catcher is filled.

6-20 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 6: Cleaning / disinfection

Press the Start/Reset key for 1 second.


The Prime LED is illuminated.

Status indicator light turns yellow


(warning/info).

Circulation
Message displayed briefly

>R<
Display message e.g. >R<

6.9.4 Setting the blood pump rate

Rate: ml/h (Ø:ml) The Operation (green) LED is illuminated.


Blood pump is rotating.
Start
Stop
Use the key  or the key  to select the
desired delivery rate.
(Pressing the key for more than
> 3 seconds: will accelerate the change
rate.)

Fresenius Medical Care 4008 S OP-EN 4/12.10 6-21


Chapter 6: Cleaning / disinfection

6.9.5 Delivery stops

When the rinse volume has been reached.

Status indicator light turns red (alarm) for


2 seconds.

>R<
Display message

The Cleaning LED is illuminated.


Audible signal
cleared automatically after 2 seconds.

It may be necessary to raise the level in the


venous bubble catcher.
Press the  key to set the desired level.

6.9.6 Interrupting precirculation

Rate: ml/h (Ø:ml) Press the Start/Stop key.


The Operation (green) LED turns dark.
Start
Stop
Continue by pressing the key again.

6-22 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 6: Cleaning / disinfection

6.9.7 Premature termination

Press the Start/Reset key for 1 second.


Press the Start/Reset key a second time to
continue precirculation.

Fresenius Medical Care 4008 S OP-EN 4/12.10 6-23


Chapter 6: Cleaning / disinfection

6-24 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

7 Functional description

7.1 Description of the procedure

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-1


Chapter 7: Functional description

7.1.1 Hydraulic flow diagram 4008 S

7-2 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

Legend 95 Bicarbonate suction tube


2 Temperature sensor 97 Air separation pump
3 Temperature sensor 99 Rinse valve
4 Temperature sensor 100 Rinse valve
5 Float switch 102 Central concentrate delivery valve
6 Level sensor 109 Temperature sensor
7 Conductivity measurement cell 110 Conductivity measurement cell
8 Blood leak detector 111 Hydrophobic filter
9 Pressure transducer 112 Vent valve
10 Reed contact for concentrate 114 Dialysate filter
12 Reed contact for bicarbonate 115 Disinfection valve sensor
21 Flow pump 116 Sampling valve
22 UF pump 117 Check valve (concentrate)
23 Concentrate pump 119 Filter (concentrate)
24 Dialyzer valve 1 121 Central concentrate delivery connection
24b Dialyzer valve 2 123 Pressure switch for V102
25 Bicarbonate pump 130 bibag® drain valve
26 Bypass valve 132 bibag® conductivity measurement cell
29 Degassing pump 133 bibag® temperature sensor
30 Outlet valve 136 bibag® connector
31 Balancing chamber valve 1 137 bibag® microswitch 1
32 Balancing chamber valve 2 138 bibag® microswitch 2
33 Balancing chamber valve 3 148 Filter/rinse valve 100
34 Balancing chamber valve 4 149 Filter/rinse valve 99
35 Balancing chamber valve 5 150 Filter
36 Balancing chamber valve 6 151 Orifice
37 Balancing chamber valve 7 182 Pressure transducer 2
38 Balancing chamber valve 8 183 Test valve
39 Negative pressure valve 184 Filter/test valve
41 Water inlet valve 185 Compressor
43 Fill valve 188 Evacuation valve
54 Heater rod 189 Retentate valve
61 Pressure reducing valve 201 Air separator
63 Filter / water inlet 202 Level sensor
65 Loading pressure valve 203 Air separator
66 Heater block 204 Level sensor
66a Water inflow chamber 205 Concentrate / bicarbonate mixing point
66b Heater block chamber 210 Filter (degassing orifice)
66c Float chamber
68 Balancing chamber Hydraulics measuring points
71 Filter / concentrate A Reduced water inlet pressure
72 Filter / bicarbonate B Balancing chamber loading pressure
73 Filter / dialysate external C Pressure flow pump
74 Filter / UF D Degassing pump pressure
76 Filter / fill valve
77 Heat exchanger
78 Relief valve
84 Disinfection valve
85 Disinfection connector
86 Recirculation valve
87 Drain valve
88 Multifunction block
88a Degassing chamber
88b Secondary air separator
88c Primary air separator
89 Degassing orifice
90a Rinse chamber concentrate
90b Rinse chamber bicarbonate
91 Rinse valve
92 Vent valve
94 Concentrate suction tube

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-3


Chapter 7: Functional description

 Description

The hydraulic compartment of the hemodialysis device consists of a


volumetric dialysate balancing system, which is closed to the
atmosphere. In the balancing chambers, the used dialysate is displaced
by fresh dialysate (and vice versa as the sequence changes). This
makes sure that equal amounts of dialysate enter and exit the dialyzer.
The fresh and the used dialysate are separated by an elastic
membrane.
The float switch (5) located in the heater block (66) controls the inflow
of fresh water via the water inlet valve (41). The upstream pressure
reducing valve (61) ensures a constant water inlet pressure.
The water is heated in the heater rod chamber (66b). The degassing
pump(29) and the degassing orifice (89) are used to generate a
negative pressure to deaerate the water. The air is collected in the
primary air separator (88c). From there, it is directed to the heater block
chamber (66b) via the loading pressure valve (65). And then discharged
into the atmosphere via the float chamber (66c).
The preheated and deaerated water is delivered from the primary air
separator (88c) to the concentrate / bicarbonate mixing point (205).
Concentrate containing acetate (or in bicarbonate-based dialysis acid
concentrate) flows from the concentrate suction tube (94) through the
concentrate air separator (201) and the concentrate pump (23) to the
concentrate/bicarbonate mixing point (205). In bicarbonate-based
dialysis, bicarbonate is transported via the bicarbonate suction tube
(95), the air separator (203) and the bicarbonate pump (25) to the
concentrate / bicarbonate mixing point (205). The evacuation valve
(188) and the bibag® drain valve (130) are provided for deaeration.
The conductivity measuring cell (132) and the temperature sensor (133)
measure and monitor the bicarbonate conductivity.
At the concentrate/bicarbonate mixing point (205) the appropriate
concentrates are mixed with water. The dialysate then flows across the
balancing chamber (68), the DIASAFE® plus (114) and the conductivity
cell (7) to the dialyzer.
The DIASAFE® plus (114) holds back pyrogenic substances and
microorganisms.
In the conductivity cell (7), both the conductivity and the temperature
(temperature sensor 3) are measured and indicated on the monitor. The
temperature sensor (109) controls the temperature.
If temperature and conductivity are inside the alarm limits, the two
dialyzer valves (24 and 24b) are open and the bypass valve (26) is
closed. Should one of the two values be outside the alarm limits
(temperature or CD alarm), the bypass valve (26) opens and the
dialyzer valve (24) closes.
The integrity of the DIASAFE® plus (114) membrane is checked by
ventilating the external capillary space via the compressor. At the same
time, V43 will be opened against the atmosphere.
The retentate valve (189) is used to rinse retentate from the internal
capillary space of the DIASAFE® plus (114).

7-4 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

The used dialysate coming from the dialyzer is monitored by a blood


leak detector (8). From there it flows into the secondary air separator
(88b) of the multifunction block. The fluid coming from this chamber is
forced by the flow pump (21) into the balancing chamber (68). This
ensures that the dialysate that is expelled is always replaced by the
same amount of fresh dialysate.
The pressure transducer (9) is located below the secondary air
separator (88b) of the multifunction block (88). The pressure measured
here is taken as a quantity in the computation of the TMP.
A membrane pump (UF pump 22) with a volume of 1 ml per stroke
withdraws fluid from the system at a specified rate. Since the system is
closed, the same volume is removed as ultrafiltrate from the blood via
the dialyzer.
After the balancing chamber (68), the used dialysate is directed to the
drain via the valve (30), the heat exchanger (77) and the drain valve
(87).
The heat exchanger (77) transmits part of the heat of the outflowing
dialysate to the cold inflowing water.
Larger amounts of air entering the system, as a result of major
deaeration or during priming, are detected by the level sensor (6). The
air is discharged into the atmosphere via the air separation pump (97).
The sampling valve (116) is located in the dialyzer inflow line. Here,
dialysate can be withdrawn with a Luer-lock syringe.
The pressure measuring points A, B, C and D allow direct measurement
of various pressures, without having to separate lines and tubings.
Measuring point A measures the water inlet pressure, B the balancing
chamber loading pressure, C the flux pump pressure, and D the
negative degassing pump pressure.
During the hot rinse and disinfection programs, the device is operated
in recirculation mode. In this case, the drain valve (87) is closed and the
recirculation valve (86) is open. This method of recirculation serves to
save energy (hot rinse) and disinfectant. The disinfectant is introduced
into the circuit by the UF pump (22) via the disinfectant valve (84) and
the sensor (115). The sensor (115) detects presence or absence of
disinfectant.
When using the CDS function (central concentrate delivery),
concentrate containing acetate, or in bicarbonate-based dialysis acid
concentrate, flows from the concentrate connector (121) through the
valve (102) to the rinse chamber (90a).

7.1.2 Central Delivery System (CDS)

The desired type of concentrate supply must be selected in the SETUP


menu (see Service Manual). The following options are available:
– No Central Delivery System (factory setting)
– Central acid delivery
– Central acetate delivery

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-5


Chapter 7: Functional description

When selecting a type of central delivery, the operator is not restricted


to the centrally supplied concentrate. Other concentrates can also be
connected by disconnection or connection of the concentrate suction
tubes. The hemodialysis device also recognizes the type of dialysis
performed (acetate or bicarbonate dialysis) and uses this information to
control the concentrate or the bicarbonate pump respectively.

Note
Aspiration of concentrates from the containers has priority.
If, with Central Delivery System, the concentrate suction tube is
repeatedly removed, the rinse chamber will overflow. The rinse
chamber will not be drained before the next cleaning program.

The operator has the option to switch off the Central Delivery System
(see chapter 4.1.4.1, page 4-3).

Note
The operator is responsible for the proper installation and function of the
CDS.

7.1.3 Description of bicarbonate dialysis

 Mode of operation

The hemodialysis device permits the optional performance of acetate or


bicarbonate dialysis.
The type of treatment is determined by:
– the concentrates
– the position of the concentrate suction tubes
For bicarbonate dialysis two concentrates are required:
– Acid concentrate
– Bicarbonate concentrate or bibag®
The concentrates are delivered by two pumps and are mixed with RO
(reverse osmosis) water in the hemodialysis device.
The concentrate suction tubes are connected to the appropriate
containers.
With CDS, the appropriate concentrates are delivered by the Central
Delivery System.
The mixing process is volumetric and proportional, i.e. the concentrate
pumps add an exact quantity of concentrate to a fixed volume of water.
The mixing ratio can be varied. The desired ratio can be selected in the
Dialysate menu. Press the Dialysate Menu key.

7-6 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

During bicarbonate dialysis, precipitation of calcium and magnesium


salts can occur. The device should therefore be decalcified and
disinfected after each bicarbonate dialysis, using a suitable agent (e.g.
Puristeril® 340 or Citrosteril®).
During a cleaning program, the concentrate suction tubes must be
inserted in the rinse ports located on the hemodialysis device.

 Concentrates for bicarbonate dialysis

After mixing, the acetic acid from the acid concentrate reacts with the
equivalent quantity of bicarbonate, producing carbonic acid and sodium
acetate.
– Acid concentrate
SK-F 203 (PGS 21) / SK-F 003 (PGS 01),
35 fold, 6 l in 10 l container.
– Bicarbonate concentrate
Sodium hydrogen carbonate solution 8.4 %,
8 l in 10 l container.

Note
The contents of opened bicarbonate concentrate containers cannot be
stored.

– Bicarbonate concentrate (bibag®)


Sodium hydrogen carbonate powder,
650 g, or 900 g bag.

 Dialysate for bicarbonate dialysis

After mixing, the acetic acid from the acid concentrate reacts with the
equivalent quantity of bicarbonate, producing carbonic acid and sodium
acetate. Carbonic acid and sodium acetate are produced.
With the pumps at standard setting, this produces dialysate, which has
the following ion composition:
– SK-F 203 (PGS 21) and 8.4 % sodium hydrogen carbonate

Sodium 138.00 mval/l 138.00 mmol/l


Potassium 2.00 mval/l 2.00 mmol/l
Calcium 3.50 mval/l 1.75 mmol/l
Magnesium 1.00 mval/l 0.50 mmol/l
Chloride 109.50 mval/l 109.50 mmol/l
Acetate 3.00 mval/l 3.00 mmol/l
Bicarbonate 32.00 mval/l 32.00 mmol/l

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-7


Chapter 7: Functional description

– SK-F 003 (PGS 01) and 8.4 % sodium hydrogena carbonate

Sodium 138.00 mval/l 138.00 mmol/l


Potassium 0.00 mval/l 0.00 mmol/l
Calcium 3.50 mval/l 1.75 mmol/l
Magnesium 1.00 mval/l 0.50 mmol/l
Chloride 109.50 mval/l 109.50 mmol/l
Acetate 3.00 mval/l 3.00 mmol/l
Bicarbonate 32.00 mval/l 32.00 mmol/l

 Concentrate connectors

Acetate dialysis

7-8 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

Bicarbonate dialysis
(bicarbonate from
containers)

Bicarbonate dialysis
(bibag®)

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-9


Chapter 7: Functional description

 Safety for bicarbonate dialysis

Safety of the procedure is ensured by:


– two independent volumetric mixing systems
– the temperature-compensated conductivity control
– color-coded suction tubes and containers
– automatic detection of the connected supply type

Procedure The dialysate is continuously prepared from bicarbonate concentrate,


acid concentrate, and reverse osmosis water.
In a volumetrically proportional mixing system two membrane pumps,
which are independent of each other, deliver the acid concentrate
solution and the bicarbonate solution.

Caution
Only the dedicated bibag® may be connected to the bibag® connector.

7-10 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

 Preparation of the dialysate (schematic)


for 4008 S

8
2
7

6
3

1 From the balancing chamber to the dialyzer


2 Bicarbonate pump
3 bibag®
4 Concentrate B (bicarbonate)
5 RO water
6 Concentrate A (acetate or acid)
7 Degassing pump
8 Concentrate pump

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-11


Chapter 7: Functional description

 Safety system

Measurement of the conductivity and the bypass function prevent that


dialysate of the wrong concentration will enter the dialyzer.
Monitoring of the rated conductivity to within ±5 % by setting alarm limits
provides a safeguard against errors in the mixing system.
In the event of dialysate of the wrong composition, the conductivity will
be outside the alarm limits. The CD alarm, which is then generated, will
cause the device to go into bypass. accompanied by an audible and a
visual alarm.
An initial error in the mixing system will be detected before the deviation
of the dialysate values from the rated value becomes dangerous.

Error Maximum deviation

Defect in the acid concentrate CD: –0.4 mS/cm


supply (pump defective, filter
clogged) always results in a Na: –4 mmol/l
decrease in concentration. Bic: ±0 mmol/l

pH: +0.04

Defect in the bicarbonate supply CD: –0.4 mS/cm


(pump defective, filter clogged)
always results in a decrease in Na: –6 mmol/l
concentration. Bic: –6 mmol/l

pH: –0.19

Defect in water supply or in the CD: ±0.4 mS/cm


balance chamber: Change in total
concentration max. approx. Na: ±6 mmol/l
0.4/13.5 = 0.03 = 3 % Bic: ±1 mmol/l

pH: ±0.05

Defect in the CD monitor: No deviation.


Incorrect reading The defect will be detected
during the next T1 test.

Defect in the CD monitor: No deviation.


Defective alarm evaluation The defect will be detected
during the next T1 test.

Mistaking bicarbonate and acid for CD outside alarm limits.


concentrate (Expected value!).
Minimized by color coding of
the containers.

Use of wrong concentrates. CD: ±0.4 mS/cm

7-12 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

 Mixing ratios

Setting in setup H2O in l Acid in l Bic. in l Mixture Mixture Display in


conc. bic. menu

1+34 32.775 1 1.225 35 28.57 1+34

1+35.83 (NaCl 20) 34 1 1.83 36.83 20.13 1+35.83(A)

1+35.83 (NaCl 26) 34 1 1.83 36.83 20.13 1+35.83(C)

1+35.83<B*> 33.8 1 2 36.83 18.42 1+35.83(B)

1+44 ACF 42.425 1 1.575 45 28.57 1+44 ACF

1+44 C 42.225 1 1.775 45 25.35 1+44 C

INDIVIDUALLY – – – – – –
ADJUSTABLE1

B* Belgian bicarbonate
1
for detailed information: see Service Manual

Note
For treatment with the bibag®, the mixing ratio must be set to 1+34 or
1+44.

 Total conductivity of the ready-to-use dialysate

The total conductivity of the ready-to-use dialysate (in mS/cm) is


determined by the acidic and basic part of the bicarbonate hemodialysis
concentrates.
The total conductivity of the ready-to-use dialysate with the appropriate
mixing ratio is indicated on each package of the acidic bicarbonate
hemodialysis concentrate from Fresenius Medical Care. In the event of
a ready-to-use dialysate with 32 mmol/l bicarbonate and 3 mmol/l acid
(e.g. acetate content), the contribution of the basic component of the
bicarbonate concentrate to the total conductivity is 2.2 mS/cm. The
contribution of the acidic component of the bicarbonate concentrate to
the conductivity depends on the different electrolytic contents.

 Change in conductivity

Based on a basic sodium value of e.g. 140 mmol, the sodium value
changes by 5 %, if the desired sodium value is increased to 147 mmol.
The total conductivity of the ready-to-use dialysate then also increases
by 5 %.
If the bicarbonate proportion is changed, the acid proportion is changed
in the opposite direction, in order to maintain the desired sodium at a
constant value. This may result in a minor CD alteration.

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-13


Chapter 7: Functional description

Example A rated sodium value of 140 mmol/l corresponds to 105 mmol/l from the
acid concentrate and 35 mmol/l from the bicarbonate concentrate. If the
bicarbonate is readjusted by + 3 mmol/l (= 38 mmol/l on the bicarbonate
pump), the acid concentrate pump is readjusted by –3 mmol/l to
102 mmol/l. The rated sodium value of 102 + 38 = 140 mmol/l is
preserved.

7.1.4 Description of the variation function

In order to improve the individual tolerance to dialysis treatments,


ultrafiltration profiles and sodium profiles can be combined either
mutually dependent (e.g. high ultrafiltration with high sodium
concentration) or independent.
Separate documentation is available from the manufacturer on request.

 Possibilities of combining UF and sodium profiles

Sodium
Ultrafiltration

7.1.5 Description of Online Clearance Monitoring (OCM)

The Online Clearance Monitoring function determines the average


effective Clearance (K) for urea, the dialysis dose Kt/V and the plasma-
Na concentration during the dialysis treatment.

 Restrictions

The following functions are not released for use with OCM:
– Single-Needle
– Single-Needle Click-Clack

7-14 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

 Clearance K

K (in ml/min) corresponds to the average effective Clearance for urea.


It indicates the blood flow percentage, which is completely free from
urea.
Clearance measurement accuracy: ±5 %.

 Dialysis dose Kt/V

Kt/V is the dialysis dose of the dialysis treatment in progress.

K blood flow completely cleared of urea per unit of time (Clearance)


t the effective dialysis time
V volume of distribution of urea

Kt measuring accuracy: 5 % (standard deviation)


The minimum Kt/V value should be 1.2.
The quality of the Kt/V information content depends on the accuracy of
the individual parameters, i.e. primarily on the accuracy of the volume
of urea distribution V that was entered. The accuracy of V is the
responsibility of the attending physician.
If no valid value for V is available (neither entered directly nor calculated
from the patient data, Kt instead of Kt/V will be calculated and displayed.

 Plasma Na

Plasma-Na+ (in mmol/l) corresponds to the sodium concentration in the


patient's plasma.
The calculation of the plasma Na+ allows an adaption of the sodium
concentration of the dialysate to the physiological value of the patient.
If the clearance is 70 ml/min, Plasma-Na+ will no longer be displayed.

Note
The Plasma-Na+ value depends on the recirculation. The typical
recirculation value is 5 - 6 %.

Note
The measurement of the Plasma-Na+ is is derived from the clearance
measurement. If filter types other than Fresenius Polysulfone filters are
used, it is therefore impossible to specify the accuracy for the sodium
content of the plasma. This will not affect the clearance values.

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-15


Chapter 7: Functional description

 General notes on measurement parameters

Caution
The treatment parameters may not be determined on the basis of the
measured parameters (Clearance, Kt/V, Plasma Na+). An independent
diagnosis must be made by the physician.
A measurement of the clearance (K) and the plasma Na+ does not
replace the therapy prescribed by the physician.

7.1.5.1 OCM measurement technique

The Online Clearance Monitoring is performed at different times during


a dialysis treatment to determine the clearance over time and to detect
a reduction in efficiency that occurred during the treatment. The
measurement can be started by the operator on the dialysis device or
can be programmed in the SETUP to start with each dialysis treatment.
During a measurement the dialyzer inlet dialysate conductivity is
adjusted in accordance with a fixed time schedule. If the base
conductivity is within certain limits, the measurement direction will
alternate.

CD
Maximum conductivity: 15.7 mS/cm, maximum
value +17.5 % from mean of CD window at start.

Min. conductivity: 12.8 mS/cm, minimum value -


17.5 % from mean of CD window at start.g.

A pre- and post-dialyzer measurement of the conductivity is performed


by two mutually independent temperature-compensated conductivity
cells.

1 Dialysate drain
2 CD cell (110)

7-16 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

3 Arterial inflow
4 Venous return
5 CD cell (7)
6 Dialysate inflow
7 Dialyzer

7.1.5.2 Time schedule of an Online Clearance Monitoring

When an OCM is started, measurement cycles are generated at regular


intervals. Direction and course of the cycles depends on external
parameters such as the current conductivity or the cyclic pressure
holding test (CPHT).
The measuring cycle starts with the CPHT. Starting condition is a stable
conductivity. The conductivity must remain stable for at least
60 seconds. Then the current conductivity will be measured and it will
be decided on the direction of the CD variation. Afterwards the actual
measuring cycle is started. The first measuring cycle is initiated
immediately after the first CPHT.
If, within a period of 120 seconds, the conductivity fails to remain stable
for 60 seconds, the measurement will be aborted.
The phase of the change in conductivity lasts for a maximum of
60 seconds. The CD variation is then followed by a phase of constant
conductivity during which the conductivity is measured at the dialysate
inlet and outlet side, and the readings taken are recorded.
The total length of a measurement is approx. 11 minutes (1 minute to
wait for the conductivity to stabilize; 10 minutes measurement phase).

Fig.: Measurement over time (schematic)

Measurement cycle

CD variation

Waiting for CD

CPHT

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-17


Chapter 7: Functional description

7.1.5.3 Sequence of measuring cycles during treatment

The interval between two measurements can be chosen freely in


increments of 12.5 minutes. The shortest interval is 25 minutes. These
measurements are synchronized with the cyclic pressure holding test
(CPHT) which is generally performed every 12.5 minutes.
If the CPHT is deactivated, 12.5 minute intervals are applied.
Deviations from this time schedule are possible in case of profile
treatment and if a cycle is aborted.
No measurement will be started if only 12 minutes are left until
completion of the UF time.
The direction of the CD variation is determined by the conductivity
before the measurement was initiated, to ensure that the conductivity
will not be outside the absolute conductivity range of 12.8 –
15.7 mS/cm. If the conductivity is below 13.9 mS/cm, the CD variation
will be raised; if it is above 14.6 mS/cm, the CD variation will be lowered.
If the conductivity is within or identical with these limits, the directions of
the measurements will alternate. With base conductivities of 13.9 –
14.6 mS/cm this will generate an alternating CD variation.

Base
conductivity
window

If Online Clearance Monitoring is aborted and restarted during a


treatment, the first CD variation of the new measurement series will be
in the opposite direction of the last CD variation before the
measurement was aborted, provided this is not prohibited by the
conductivity.

7.1.5.4 Cyclic pressure holding test

During the cyclic pressure holding test, the dialysis device is in the
extended bypass mode, i.e. during this time (for approximately
20 seconds) the dialysate flow through the dialyzer is stopped
(0 ml/min).
The dialysate flow will be included in the calculation of the clearance,
i.e. the clearance during this time is also zero. As the clearance is
updated at intervals of 1 minute, the clearance value following a cyclic
pressure holding test drops to about 2/3rd of the mean value.

7-18 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

OCM diagram

CPHT

 Retentate rinsed from the DIASAFE

During Online Clearance Monitoring, rinsing of retentate from the the


DIASAFEplus filter is suppressed and is performed on completion of the
measurement.

7.1.5.5 Safety during an OCM

Safety of the procedure is ensured by continuous temperature-


compensated monitoring of the conductivity.

7.1.5.6 Maintenance

The OCM PULSE calibration has to be checked for the OCM function
within the scope of the Maintenance procedures.

7.1.5.7 Technical Safety Checks

The routine TSCs intervals for the dialysis device are to be applied.

7.1.6 Description of the DIASAFE® plus

 System components

DIASAFE® plus The DIASAFE® plus is a hollow-fiber filter. Its excellent filtering
characteristics can be attributed to the Fresenius Polysulphon®
membrane used.

Pressure transducer 2 This transducer is a sensor mounted as a standard component in the


hydraulic unit. It is used to control and evaluate the membrane integrity
test.

Compressor The compressor is required for testing the integrity of the membrane of
the DIASAFE® plus. Within a minimum of time it ventilates one side of
the filter membrane until the test pressure is achieved.

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-19


Chapter 7: Functional description

Test valve The test valve is only open as long as the compressor ventilates the
filter membranes and the test pressure has built up.

Hydrophobic filter (111)


Vent valve (112) Filter/test valve (184)
Compressor (185)
Test valve (183)

DIASAFE® plus
Drain Balancing Air detector
chamber P Pressure transducer
valve
(114)

Cond./temp.

(3/7/109)
monitoring
(68) 2 (182) P Monitor, venous
pressure
transducer

(189)
Retentate valve
Venous bubble
Bypass catcher
valve
Pressure transducer (9)
Flow pump (21)

Air detector
UF pump (22)
Fill valve (43)

(26)
Dialyzer valve 1

Dialyzer
(24)

Venous line clamp

Dialyzer
valve 2
P P
(24b)

monitor
Arterial bubble catcher

Arterial pressure
Arterial blood pump
Membrane integrity test The integrity of the membrane of the DIASAFE® plus is tested by
DIASAFE® plus means of a pressure holding test. This test is carried out in the T1 test.
For the test, the outer capillaries of the DIASAFE® plus are ventilated.
This is done by the compressor which pumps air via the test valve into
the hydraulic system. The inflowing air displaces the fluid in the system
via the hydrophilic filter membrane and the retentate valve into the
drain. This process continues until the entire outer capillary space is
filled with air. As air cannot pass across an intact membrane, a positive
pressure will build up on the ventilation side. The pressure transducer 2
controls the compressor and evaluates the integrity test. When the test
pressure has been achieved, the compressor is switched off and the
test valve closes. The pressure drop per unit of time is used as a
measure for the evaluation of the integrity of the membrane.

7-20 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

Hydrophobic filter (111)


Vent valve (112) Filter/test valve (184)
Compressor (185)
Test valve (183)

DIASAFE® plus
Drain Balancing
chamber P Pressure transducer
valve

(114)

(3/7/109)
Cond./temp.
monitoring
(68) 2
(182)

(189)
Retentate valve
Bypass
valve
Pressure transducer (9)
Flow pump (21)
UF pump (22)
Fill valve (43)

(26)
Dialyzer valve 1
(24) Shunt interlock

Dialyzer valve 2
(24b)
P

 Dialysis

The fresh dialysate flows from the balancing chamber to the


DIASAFE® plus.
It is integrated in the hydraulic system to ensure that in a no alarm state
(no dialysate alarm: V26 closed, V24 and V24b open) the "fresh"
dialysate flows across the filter membrane.
Ultrapure dialysate enters the dialyzer via valve V24.
In bypass mode (dialysate alarm: V26 open, V24 and V24b closed) fluid
flows through the inner capillary space of the DIASAFE® plus. Possible
retentate is rinsed from the capillaries and transported to the drain. Thus
overcoming the disadvantages of a dead end filtration.

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-21


Chapter 7: Functional description

Hydrophobic filter (111)


Vent valve (112) Filter/test valve (184)
Compressor (185)
Test valve (183)

DIASAFE® plus
Balancing Air detector
Drain
chamber P Pressure transducer
valve

(114)

(3/7/109)
Cond./temp. monitoring
(68) 2 (182) P Monitor, venous
pressure
transducer

(189)
Retentate valve
Venous bubble
Bypass catcher
valve
Pressure transducer (9)
Flow pump (21)

Air detector
UF pump (22)
Fill valve (43)

(26)
Dialyzer valve 1

Dialyzer
(24)

Venous line clamp

Dialyzer
valve 2
P P
(24b)

Arterial bubble catcher

monitor
Arterial blood pump

Arterial pressure
 Cleaning

During the cleaning programs the dialysate lines (red/blue) are


connected to the shunt interlock.
The cleaning agent, water or disinfectant flow via the balancing
chamber to the DIASAFE® plus. As the retentate valve, V26 and
V24/24b open alternatingly, fluid flows alternatingly through the inner
capillary space and the membrane of the filter.

7-22 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

Hydrophobic filter (111)


Vent valve (112) Filter/test valve (184)
Compressor (185)
Test valve (183)

DIASAFE® plus
Drain Balancing
chamber P Pressure transducer
valve

(114)

(3/7/109)
Cond./temp.
monitoring
(68) 2 (182)

(189)
Retentate valve
Bypass
valve
Pressure transducer (9)
Flow pump (21)
UF pump (22)
Fill valve (43)

(26)
Dialyzer valve 1
(24) Shunt interlock

Dialyzer valve 2
(24b)
P

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-23


Chapter 7: Functional description

7.2 Description of the extracorporeal blood circuit

7.2.1 Double-Needle dialysis

1a External hydrophobic filter


2 Arterial pressure monitor
3 Arterial blood pump
4 Heparin pump
5 Arterial bubble catcher
6 Dialyzer
7a External hydrophobic filter
7b Internal hydrophobic filter
8 Vent valve
9 Monitor for venous back pressure

7-24 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

10 Ventilation pump
11 Hydrophobic filter
12 Air detector
13 Venous line clamp
14 Optical detector

 Description

The arterial blood pump pumps the blood from the patient’s vascular
access to the dialyzer. The pressure on the suction side of the pump is
measured and monitored by the arterial pressure monitor, which is
separated by a hydrophobic filter. Should the pressure exceed or fall
below the set limits, a blood alarm is released: the arterial blood pump
stops, the venous line clamp is closed, a visual and audible alarm is
emitted. Ultrafiltration is stopped.
The heparin pump is used to administer heparin doses to the blood at
an adjustable rate. The stop time is a programmable period of time
ranging from 0 min to 2 hours. It determines the point in time when
heparinization will be stopped before the end of the treatment.
After the dialyzer, the blood enters the venous bubble catcher. There,
the venous return pressure is measured and monitored within tight
limits. The monitor for the venous return pressure is separated by two
hydrophobic filters. The venous bubble catcher is positioned in the air
detector. The air detector is a safeguard against infusion of air. Should
the level drop or should there be frothy blood in the venous bubble
catcher, a blood alarm is emitted: the arterial blood pump stops, the
venous line clamp is closed, a visual and audible alarm is emitted.
Ultrafiltration is stopped.
After the bubble catcher, the blood passes the optical detector (OD). It
differentiates as follows:
– OD senses light (saline or air in the blood line) or
– OD senses dark (blood in the blood line).
From the optical detector, the blood is then returned to the patient
(venous needle).

7.2.2 Single-Needle Click-Clack dialysis

Note
This procedure should be used in exceptional cases only, since the
stroke volumes and, thus, the corresponding recirculation can be very
unfavorable.

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-25


Chapter 7: Functional description

 Example for the application of this procedure

Should blood flow problems arise in one of the vascular accesses


during Double-Needle dialysis, it is still possible to continue the
treatment using the installed blood lines by selecting SN-Click-Clack.
After the switching pressure values have been entered, the venous
pressure transducer controls the blood pump and the venous line
clamp. Both the arterial and the venous blood lines are connected to the
remaining vascular access by means of a Y-piece.
The venous line clamp is closed, as long as the arterial blood pump is
delivering blood. As soon as the upper limit on the venous pressure
transducer has been reached in the blood lines, the blood pump stops
and the venous line clamp opens. The pressure, which has developed
in the blood lines returns the stored blood to the patient. As soon as the
set lower limit has been reached, the venous line clamp closes, the
arterial blood pump starts running, and the same procedure is repeated
at regular intervals.
If the cycle time is exceeded by 15 s, an alarm will be emitted. The
venous line clamp is closed. The blood pump and the UF pump stop
running.

7-26 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

7.2.3 Single-Needle dialysis (option)

1a External hydrophobic filter


2 Arterial pressure monitor
3 Arterial blood pump
4 Heparin pump
5 Arterial bubble catcher
6 Dialyzer
7a External hydrophobic filter
7b Internal hydrophobic filter
8 Vent valve
9 Monitor for venous back pressure
10 Ventilation pump
11 Hydrophobic filter
12 Air detector
13 Venous line clamp

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-27


Chapter 7: Functional description

14 Optical detector
15a External compliance chamber
15b Internal compliance chamber
16a External hydrophobic filter
16b Internal hydrophobic filter
17 Monitor for SN control pressure
18 SN blood pump

 Description

During SN dialysis, blood is alternately collected from and returned to


the patient through one needle. This is achieved by means of an
additional blood pump, which includes the Single-Needle control
electronics (2-pump procedure with pressure-pressure control).
With SN (QSN) in the twin-pump SN system, the mean blood flow is
computed as follows:
QSN = (BPRart x BPRSN) / (BPRart + BPRSN)
[theoretical value]
The following approximation formula is sufficient for practical use:
QSN = (BPRart + BPRSN) / 4
The arterial blood pump pumps blood into the external compliance
chamber. The blood volume is dependent upon the set stroke volume
(10 – 50 ml). The SN blood pump is not running. The venous line clamp
is closed. The external compliance chamber is connected to a pressure
transducer in the SN blood pump. The compliance chamber, which is
filled with air, is located inside the SN blood pump. As soon as the
pressure exceeds the set upper limit, the arterial blood pump stops. The
SN blood pump starts and pumps the blood through the dialyzer, the
venous bubble catcher and the venous line clamp into the patient. As
soon as the pressure in the internal compliance chamber drops below
the set lower limit, the described procedure is restarted.
The lower switching point is fixed to 75 mmHg. The upper switching
point depends on the stroke volume entered.

Stroke volume (ml) 10 15 20 25 30 35 40 45 50

Upper switching point (mmHg) 110 130 150 172 195 219 244 270 299

The position of the SN blood pump before the dialyzer prevents level
fluctuations in the venous bubble catcher. It also improves the stability
of the TMP.
The therapeutical result (clearance) depends on the effective blood flow
and the stroke volume. The higher the stroke volume, the lower the
recirculation volume. For this reason, the largest possible blood flow
and the largest possible stroke volume should be set. These settings
differ from patient to patient and, owing to the individual vascular
accesses, have different limits.

7-28 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

All other components and their functions correspond to those already


described for Double-Needle dialysis.
The stop detection of both blood pumps is activated. Should one of the
pumps stop for longer than the set time 30 seconds), a blood pump stop
alarm will be emitted.

Note
The design (closed system) of the hemodialysis device 4008 S ensures
that pressure fluctuations during SN operation will not affect the UF rate
or the UF volume.

7.2.4 Effective blood flow and accumulated blood volume

The delivery rate display on the blood pump indicates the theoretical
blood flow. This value is calculated from the rotor speed and the inside
diameter of the blood line used.
The actual blood flow (effective blood flow) may deviate slightly from
this value, because it depends on the different input pressures (arterial
pressure) on the pump.
The processor of the monitor contains an algorithm which corrects the
theoretical blood flow, dependent on the arterial pressure. The value is
displayed in the current dialysis menu.
Using the actual blood flow and the elapsed treatment time, the monitor
computes the accumulated blood volume. This information is shown in
the menu Dialysis in the window Cum. Blood Vol..

7.3 Cleaning programs

7.3.1 General information on the cleaning programs

The length of the individual cleaning programs can be freely selected.


(see Service Manual, adjustment instructions in the SETUP menu.)

Note
Flow alarms during cleaning programs will increase the length of the
cleaning program by the time of the alarm.

Note
If the hemodialysis device remains in the no-program state for more
than 10 minutes after completion of a cleaning program, the device will
turn off automatically.
Exceptions:
– If the cleaning program was started with Auto On and if the function
"AutoOFF after AutoON" is deactivated.
– if the cleaning program was interrupted (e.g. suction tube twisted).

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-29


Chapter 7: Functional description

The following components and functions are monitored during the


cleaning programs:
– Dialyzer valve
– Bypass valve
– Balancing chamber switching pulse (flow)
– Float switch
– UF pump
– Temperature
– Supply Voltages 24 V and 12 V
– Software watchdog
– Shunt interlock flap
– Dialyzer lines connected
– Concentrate and bicarbonate suction tubes connected
– CDS
– V84
– Retentate valve

7.3.2 Disinfection, decalcification

Note
If the device has been idle for more than 72 hours, it is recommended
to run a disinfection program before initiating the next treatment.

During these programs, the hemodialysis device is


– thermally disinfected and decalcified (using Fresenius Citrosteril® or
Fresenius Diasteril®)
– disinfected and decalcified (using Fresenius Puristeril® 340)
– disinfected (using Fresenius Sporotal® 100)
The agent for disinfection (Puristeril® 340) and for thermal disinfection
(Citrosteril® or Diasteril®) is connected on the rear of the device
(disinfection programs 1 to 4).
Irrespective of the container connected to the rear of the device, the
special program 5 can be used , if necessary, to draw in a hypochlorite-
containing disinfectant (e.g. Sporotal® 100) from the front via the
concentrate suction tube.

Note
When using Diasteril®, a mandatory rinse time of at least 17 minutes
must be programmed.

7-30 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 7: Functional description

Note
The heat disinfection program may only be performed with Citrosteril®
or Diasteril®.
If a different type of disinfectant is connected to the rear of the device
when changing the program (e.g. Puristeril® 340 instead of Citrosteril®
or Diasteril®), the previously used disinfectant must be thoroughly
rinsed from the suction tube.
When the disinfectant is to be drawn in from the front (PGM 5), ensure
that a container with a sufficient amount of disinfectant is connected.
Avoid aspiration of air.

 Disinfection flow chart

Disinfection Hot disinfection Disinfection + hot Hot disinfection + Cleaning


rinse hot rinse (front supplied)

PGM 1: PGM 2: PGM 3: PGM 4: PGM 5:


–F–D–M– –F–HDIS–M– –F–D–M–HR– –F–HDIS–M–HR– –F–D(F)–M–

–F– –F– –F– –F– –F–

Temp.: 37 °C Temp.: 37 °C Temp.: 37 °C Temp.: 37 °C Temp.: 37 °C

Flow: 600 ml/min Flow: 600 ml/min Flow: 600 ml/min Flow: 600 ml/min Flow: 600 ml/min

Time: 4–10 min* Time: 4–10 min* Time: 4–10 min* Time: 4–10 min* Time: 4–10 min*

–D– –HDIS– –D– –HDIS– –D(F)–

Temp.: 37 °C Temp.: 84 °C Temp.: 37 °C Temp.: 84 °C Temp.: 37 °C

Flow: 600 ml/min Flow: 450 ml/min Flow: 600 ml/min Flow: 450 ml/min Flow: 600 ml/min

Time: 10–20 min* Time: 10–20 min* Time: 10–20 min* Time: 10–20 min* Time: 10–20 min*
Timer Timer
counter: counter:
From >80 °C From >80 °C

–M– –M– –M– –M– –M–

Temp.: 37 °C Temp.: 37 °C Temp.: 37 °C Temp.: 37 °C Temp.: 37 °C

Flow: 600 ml/min Flow: 600 ml/min Flow: 600 ml/min Flow: 600 ml/min Flow: 600 ml/min

Time: 15–30 min* Time: 15–30 min* Time: 15–30 min* Time: 15–30 min* Time: 15–30 min*

–HR– –HR–

Temp.: 84 °C Temp.: 84 °C

Flow: 450 ml/min Flow: 450 ml/min

Time: 10–20 min* Time: 10–20 min*


Timer Timer
counter: counter:
from >80 °C from >80 °C

Fresenius Medical Care 4008 S OP-EN 4/12.10 7-31


Chapter 7: Functional description

7-32 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 8: Consumables / accessories / additional equipment

8 Consumables / accessories / additional


equipment

Caution
The device has been approved for use with specific consumables and
accessories (see chapter 8, page 8-1).
Should the responsible organization wish to use other consumables
and accessories than those listed in the above-mentioned chapter, the
responsibility to ensure the correct function of the device 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 device resulting from the use of non-approved or unsuitable
consumables or accessories.

Upon request the local service will provide information about further
accessories, consumables and other additional equipment.

 The following versions of the hemodialysis device are available

1. V 10

 The following accessories (options) are available

1. Single-Needle blood pump


2. BPM 4008 Blood Pressure Monitor
3. Central Delivery System
4. AdaptedFlow

 Other additional equipment

1. Remote control (separate OP)


2. Equilibration chamber
3. Water inlet filter (cannot be used in combination with the “Integrated
hot rinse” function)

Fresenius Medical Care 4008 S OP-EN 4/12.10 8-1


Chapter 8: Consumables / accessories / additional equipment

8.1 Disposables

Caution
The dialyzers, tubing systems and syringes listed in this chapter are
disposables.

Identified by the symbol:


2 = do not re-use.

 Dialyzer

FX-Class High-Flux dialyzer

Description Information Sterilization

Fresenius FX 60 Surface 1.4 m2 INLINE steam-sterilization

 Blood lines

Caution
These blood lines match the pressure limiting system of the blood
pumps.
In order to avoid cross infections at the pressure ports, the use of
hydrophobic filters is required.
Optimum Single-Needle operation is only achieved by using the original
blood lines.
During continuous operation, the blood lines must be exchanged after
24 hours at the latest.

Double-Needle dialysis:

Description Venous bubble catcher Sterilization

AV-Set B-R 22 mm E-beam

Single-Needle dialysis:

Description Venous bubble catcher Sterilization

AV-SN-Set B-R 22 mm E-beam

8-2 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 8: Consumables / accessories / additional equipment

 Disposable syringes

Note
To calculate the delivery rate, a 20 ml B&D syringe has been used and
released. It is not advisable to use syringes of other brands, as this
could lead to severe deviations in the delivery rate.

Description Information

20 ml heparin syringe B&D Plastipak Luer-lock connector, latex-free.

8.2 Consumables

 Hemodialysis concentrates

Fresenius solutions for bicarbonate dialysis:


– Acid concentrate 35 fold,
e.g. SK-F 003 (PGS 01), SK-F 203 (PGS 21) and
SK-F 213 (PGS 22)
– Sodium hydrogen carbonate 8.4 %
Fresenius bibag® for the bicarbonate dialysis:
– Sodium hydrogen carbonate powder
650 g or 900 g

Maximum treatment times per bibag® dependent on the


dialysate flow:

Flow 650 g 900 g

300 ml/min approx. 10 hours approx. 15 hours

500 ml/min approx. 6 hours approx. 9 hours

800 ml/min approx. 4 hours approx. 6 hours

 Saline solution

Isotonic saline solution available in various bag sizes:


– Fresenius PVC bag with plug
– Fresenius Freka-Flex bag
– Fresenius Duoflex bag

 Disinfectants

Solutions for disinfecting and removing calcium deposits from the


dialysate circuit

Fresenius Medical Care 4008 S OP-EN 4/12.10 8-3


Chapter 8: Consumables / accessories / additional equipment

Caution
Strictly observe the following information:
– The printed expiry date.
– The storage conditions for the disinfectant concentrates.
– The manufacturer’s instructions for use.

Caution
Prior to the use of disinfectants other than those listed here, their
efficacy and compatibility with the materials affected in the hemodialysis
device and the DIASAFE® plus must be ensured.
Improper use of disinfectants (concentration, temperature range, dwell
time) may result in damage to the dialysis device and the
DIASAFE® plus.

Caution
The following must be observed when using Puristeril® plus:
In case of treatments with High-Flux membranes, we additionally
recommend to perform a regular alkaline cleaning with Sporotal® 100.

Disinfection Dilution:
The container concentrate is diluted in the dialysis device with permeate
water in a ratio of 1+24 (cleaning programs 1-4) or 1+34 (cleaning
program 5).

Fresenius Puristeril® 340

Water temperature during the cleaning program: 37 °C

Active substance base: peracetic acid

Active substance concentration: approx. 0.15 % (diluted)

Fresenius Puristeril® plus

Water temperature during the cleaning program: 37 °C

Active substance base: peracetic acid

Active substance concentration: < 0.1 % (diluted)

Fresenius Sporotal® 100

Water temperature during the cleaning program: 37 °C


(only cleaning program 5)

Active substance base: sodium hypochlorite

Active substance concentration: approx. 0.1 % (diluted)

8-4 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 8: Consumables / accessories / additional equipment

Note
Only applicable for DIASAFE® plus:
After installation, the DIASAFE® plus can be cleaned with
Sporotal® 100 for a maximum of 11 times.
The cleaning process using Sporotal® 100 is monitored by the
hemodialysis device.

Fresenius Citrosteril®

Water temperature during the cleaning program: 84 °C

Active substance base: citric acid hydrate

Active substance concentration: approx. 0.8 % (diluted)

Fresenius Diasteril®

Water temperature during the cleaning program: 84 °C

Active substance base: hydroxyacetic acid

Active substance concentration: approx. 0.8 % (diluted)

Note
When using Diasteril®, a mandatory rinse time of at least 17 minutes
must be programmed.

Decalcification
Fresenius Puristeril® 340

Water temperature during the cleaning program: 37 °C

Active substance base: peracetic acid

Active substance concentration: approx. 0.15 % (diluted)

Fresenius Puristeril® plus

Water temperature during the cleaning program: 37 °C

Active substance base: peracetic acid

Active substance concentration: < 0.1 % (diluted)

Fresenius Medical Care 4008 S OP-EN 4/12.10 8-5


Chapter 8: Consumables / accessories / additional equipment

Fresenius Citrosteril®

Water temperature during the cleaning program: 84 °C

Active substance base: citric acid hydrate

Active substance concentration: approx. 0.8 % (diluted)

Fresenius Diasteril®

Water temperature during the cleaning program: 84 °C

Active substance base: hydroxyacetic acid

Active substance concentration: approx. 0.8 % (diluted)

Note
When using Diasteril®, a mandatory rinse time of at least 17 minutes
must be programmed.

Indicator for disinfectants

Caution
A check for residual disinfectant on the drain line of the hemodialysis
device is always recommended.
In case other test methods are applied, the operator bears the
responsibility of this decision.

Potassium-iodide-starch paper:

Detection of residual Puristeril or Sporotal


(violet coloring – iodine precipitation)

Caution
Always use fresh (white) indicator paper.

8-6 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 8: Consumables / accessories / additional equipment

Determination of the pH

Checking for Diasteril® (pH test strips).

Caution
Test for approx. 10 to 15 sec. If the pH is too high (color change, pH less
than 4.1), run a rinse program for a minimum of 5 minutes. Then
perform a further test to determine the pH.

Solutions for external


disinfection and cleaning Fresenius ClearSurf™:
of the device and the filter
housing of the Type of disinfection: scouring/wiping disinfection
DIASAFE® plus
Active substance base: cationic tensides

Active concentration: see product description


0.5 % – 1 hour
1.0 % – 15 minutes

 DIASAFE® plus

Caution
Use only the original DIASAFE® plus specified herein.

Observe the “use by” date printed on the packaging.

Symbol "use by":

Fresenius Medical Care 4008 S OP-EN 4/12.10 8-7


Chapter 8: Consumables / accessories / additional equipment

8.3 Accessories

8.3.1 Blood pressure cuffs / pressure tubing

 Blood pressure cuffs

Description Part number Information

Blood pressure cuff M35 972 1 Adults – thin arms,


(Velcro) Arm circumference 17 cm to 26 cm

Blood pressure cuff M35 969 1 Adults – standard,


(Velcro) Arm circumference 24 cm to 32 cm

Blood pressure cuff M35 974 1 Adults – fatter arms,


(Velcro) Arm circumference 32 cm to 42 cm

Blood pressure cuff M35 975 1 Adults – thigh,


(Velcro) Circumference 42 cm to 50 cm

Blood pressure cuff M35 973 1 Children,


(Velcro) Arm circumference 13 cm to 20 cm

 Pressure tubing

Description Part number Information

Pressure tubing M39 417 1 Non-conductive straight tube


(silicone)

Pressure tubing M35 618 1 Non-conductive spiral tube (latex)

8-8 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 9: Installation

9 Installation

9.1 Important information before initial start-up

The following points must be strictly observed to assure safe operation


of the hemodialysis device:

Electrical installation – The national standards and regulations (e.g. in Germany DIN
VDE 0100-710) are to be observed when connecting the device to
the local power supply system.
– When using safety class I systems, the quality of the protective
ground of the installation is of particular importance. It must be taken
into consideration that in many countries regulations have been
enacted by national authorities.
– If the power cable needs to be replaced, use only the original power
cable listed in the spare parts catalog.
– Connect the equipotential bonding to the rear of the device, if this is
required by the legal regulations of the place of installation (e.g.
according to DIN VDE 0100-710 in rooms of application group 2).

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

Fresenius Medical Care 4008 S OP-EN 4/12.10 9-1


Chapter 9: Installation

Caution
When using central venous catheters the following precautions must be
observed:
1. The dialysis device must be connected to a potential equalization.
2. If additional electro-medical devices are connected to the patient or
they are positioned within close proximity of the patient, it must be
ensured that all leakage currents of these devices (device leakage
currents, housing leakage currents, earth leakage currents and
patient leakage currents) are below the respective limit for CF
applied parts.
This means:
Maximum 10 µA in normal cases and 50 µA in "Single fault
condition".
This also applies to patient positioning devices (e.g. patient chairs).
Devices with leakage currents within these limits, but with an
application current exceeding the specified leakage currents (e.g. on
electro stimulators) must not be used. This concerns to defibrillators,
which have no applied part of the CF type.
If all requirements have been fulfilled, these devices may be
operated on the patient or within the reachable area of the patient,
provided they are, like the dialysis device, integrated into the
potential equalization.
If these conditions are not fulfilled, no other additional electro-
medical device must be connected to the patient or positioned within
the reachable area of the patient.
In case of doubt, ask your local technician.

Leakage currents from additional


electro-medical devices may flow
via the central venous catheters to
the earth.
Catheters

Dialysis device Additional


electro-medical
device

all types!
(B / BF / CF)

Housing
leakage currents
all types
The patient is 10 times larger than
connected „CF“ patient
electrically leakage current!
to earth potential
via the blood and
the
dialysate.

9-2 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 9: Installation

3. When determining the room design, a group 1 room is sufficient, i.e.,


the mains can be turned off in case of a single fault condition, and
the treatment can be stopped or repeated.
Additionally, the room must comprise a potential equalization. For
further information refer to the national regulations.

– If additional devices, which are not included in the accessories, are


connected to the hemodialysis device, there will be the danger of
exceeding the permissible leakage currents.
– Do not operate system or devices, radiating electromagnetic waves
(e.g. walkie-talkies, wireless phones, wireless CB transmitting sets),
in the vicinity of running hemodialysis devices. The use of this
equipment may cause malfunctions in the respective hemodialysis
device.

 Batteries

Charging the integrated Upon receipt of the hemodialysis device, the integrated batteries must
batteries be charged as follows:
– Connect the device to the external power supply by means of the
power cable.
– Then turn the device on for approx. 10 hours.
If the device is not used, this procedure should be repeated every six
months.

 Water supply

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 device
must be disconnected from the RO unit at the water supply.
During cleaning of the CDS distribution tubing, the hemodialysis device
must be disconnected from the CDS.
To ensure permanently the optimum water quality, perform regular
checks and, if necessary, disinfection/cleaning cycles of the water
supply system. This also applies to the water supply tubing connected
to the hemodialysis device.

– Only water, which is suitable for hemodialysis, should be used for


operating the hemodialysis device. The quality of the water should
comply with the local regulations (e.g. European Pharmacopoeia –
Ph. Eur.).

– The ranges of the following parameters are specified in (see


chapter 12, page 12-1): water inlet pressure, supply pressure of the
dialysate concentrate, temperature, and flow rates, which are
required for operating the hemodialysis device.

Fresenius Medical Care 4008 S OP-EN 4/12.10 9-3


Chapter 9: Installation

– The national rules and regulations with regard to the prevention of


reverse flow into the water supply network and the air gap between
drain connection and sewage connection must be observed when
installing and operating the device (e.g. in Germany VDE 0753,
part 4). For further information refer to (see chapter 12, page 12-1)
Specifications.

 Water supply DIASAFE® plus

When using the DIASAFE® plus,attention should be given to the points


listed below with regard to the quality of product water, concentrate and
dialysate:

Caution
Use only reverse osmosis water.
Always ensure that both product water and dialysate meet the
applicable standard (see below).
For microbiologic quality standards / recommendations refer to the
following table.

General notes The microbiologic purity of dialysate prepared in the dialysis center is of
critical importance.

Product water quality The European Pharmacopoeia - 4th Edition lists maximum limits for
chemical and microbiological quality.
Modern reverse osmosis units and the appropriate design of water
storage and delivery systems (e.g. short distribution loops avoiding
stagnant flow zones) enable compliance with this standard.

Concentrate quality While acid concentrate may be considered bacteriostatic, bicarbonate


concentrate is an ideal nutrient medium for microorganisms. The use of
sterile or microorganism-poor concentrates is recommended. On-line
dry concentrates (bibag®) aid the preparation of dialysate with high
microbiological quality. The use of residues from open canisters and the
preparation of bicarbonate concentrate in the dialysis center are not
recommended. Central Delivery Systems for concentrate or dialysate
must meet high hygienic standards and require regular inspection.

Dialysate quality The DIASAFE® plus removes bacteria and endotoxins from dialysate
thus enabling the preparation of ultrapure dialysate.
Even when using the DIASAFE® plus, it must still be ensured that the
microbiological quality standards are complied with.

9-4 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 9: Installation

Microbiological quality
standards /
recommendations

Purified water Concentrate Dialysate (not High-purity


filtered) dialysate

Microbial counts <100 <1000 <1000 <1


(in CFU/ml)

Endotoxins (in <0.25 <1 <1 <0.03


IU/ml)

CFU Colony-Forming Units


IU International Units

 Functional checks

Prior to each treatment, the prescribed functional checks must be


performed (see chapter 4.1.10.1, page 4-32)

 Important documents

On request, circuit diagrams, descriptions, spare parts lists, and other


documents are made available by the manufacturer. These are
intended to support the responsible organization’s trained personnel in
servicing and repairing the device.
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.

Note
The device may only be used as specified in the system documentation.
Only under these conditions will the manufacturer consider himself
responsible for any effects on the safety, the reliability, and the
performance of the device.

9.1.1 Connecting the hemodialysis device

Initial start-up of the device should be performed by the


Fresenius Medical Care technical customer service or a person
authorized by them.
When bringing the hemodialysis device from a cooler into a warmer
room, allow approx. 2 hours for the device to adjust to the ambient
temperature before switching the device on.

Fresenius Medical Care 4008 S OP-EN 4/12.10 9-5


Chapter 9: Installation

Prior to the initial start-up, check the position of the DIP switches, and
adjust them, if necessary. The setting in the SETUP must also be
checked. (Refer to the Service Manual.) The current DIP switch settings
must then be entered in the Medical Device Register

Caution
Observe the following rules of hygiene when connecting to the water
supply:
– Only use tubing with undamaged packaging.
– Do not open the packaging until shortly before installing the tubing.
– Avoid touching the ends of the tubing and the adapters, if possible.

Connect water supply.


The accessories include a fabric-enforced tubing (red), 10 x 16 mm in
size, with 3/4 " screw cap and tube clamps.
The tubing length must not exceed 3 m.
Connect water drainage.
The accessories include a fabric-enforced tubing (black).
The tubing length must not exceed 3 m.
The drain height must be 0 – 100 cm (above the ground).
Each dialysis device must have its own free fall air gap of at least 2 cm.
Connect the device to the power source.
For the Central Delivery System (CDS) function:
Connect to the Central Delivery System. Use the enclosed connecting
tubes.

Caution
If the dialysis device is being connected for the first time, the technical
data should also be taken into account (see chapter 12, page 12-1).

Turn on the water supply.

Power switch (main switch)

9-6 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 9: Installation

Press the On/Off key.


Turn the hemodialysis device on!

On/Off LED is illuminated.

Display message
The Cleaning LED is flashing.
Connect the dialyzer connecting tubes to the
shunt interlock, close the shunt door.
Place the red concentrate suction tube into
the rinse port.
Place the blue bicarbonate suction tube into
the rinse port.

Note
To avoid problems during the mandatory rinse (to remove the anti-
freeze) the service switch must be set on ON (up). On completion of the
mandatory rinse set the service switch back to OFF (down).

Press the Cleaning key.


The Cleaning LED is flashing.

Fresenius Medical Care 4008 S OP-EN 4/12.10 9-7


Chapter 9: Installation

Cleaning menu
Use the Arrow keys to select the desired
cleaning program.
Press the Conf key.
The Cleaning LED is illuminated.

The selected cleaning program in progress is


displayed (e.g. Mandatory rinse).

At the end of the rinse program, the program


is automatically terminated.
The Cleaning LED turns dark.

If no DIASAFE® plus is used, the user can


now perform the Technical Safety Checks
(TSC) (see chapter 11, page 11-1).

9-8 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 9: Installation

9.1.2 Inserting / filling the DIASAFE® plus

Caution
Observe the following rules of hygiene when inserting the
DIASAFE® plus:
– Only use filters with undamaged packaging.
– Only remove the packaging and the protective straps immediately
before installing the filter.
– Avoid touching the connectors.

Note
The installation of the DIASAFE® plus must be entered in the Medical
Device Register (date, batch number). Verify, and if necessary adjust,
the DIP switch settings prior to initial start-up. Record the settings in the
Medical Device Register.

 Basic conditions

– The optical detector in the air detector module senses light.


– The dialysate connectors (red/blue) are in the shunt interlock.
– The shunt interlock flap is closed.
– The concentrate suction tubes must be locked inside the rinse
chamber.

 Operator steps

Press the Cleaning key.

Fresenius Medical Care 4008 S OP-EN 4/12.10 9-9


Chapter 9: Installation

Cleaning menu
Use the Arrow keys to select the Filter
change program.

Press the Conf key.

Info message
Emptying filter
Info message

Info message
Filter changed?
Info message

9-10 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 9: Installation

2 1. Open the locking lever.


2. Slide the protective caps up and out.
1

1
1. Slide the new filter from the top into the
guide slot.
2. Close the locking levers.
2

Press the Conf key.

Fresenius Medical Care 4008 S OP-EN 4/12.10 9-11


Chapter 9: Installation

Info message
Filling filter
Info message

Cleaning menu
Disinfect as specified in the Operating
Instructions.

Caution
Disinfect prior to the first treatment.

Perform the Technical Safety Checks (TSC)


(see chapter 11, page 11-1).

9-12 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 10: Transport / storage

10 Transport / storage

10.1 Transport

10.1.1 Inside buildings

Lift the brake lever.

The hemodialysis device can be swiveled,


turned or moved in any direction.

To overcome uneven Always push the hemodialysis device slowly across uneven surfaces to
surfaces (e.g. elevator avoid damage or prevent the device from falling over.
entry)

Overcoming steps or stairs A minimum of two persons are required for overcoming steps or stairs.
Proceed as follows:
– Lock the brake.
– Clamp the vent tubing by means of arterial forceps.
– Tilt the device.
– Lift and move the device. (Do not lift the device by means of the IV
pole or one of the modules.)
– Put the device down and set it up in reverse order.

Fresenius Medical Care 4008 S OP-EN 4/12.10 10-1


Chapter 10: Transport / storage

10.1.2 Outside buildings

– Never push the hemodialysis device across an uneven paving (e.g.


cobblestone pavement). Always lift it.
– In vehicles, always transport the device standing upright or lying and
protect it with an appropriate padding.
– During prolonged transport outside buildings, pay attention to the
storage temperature area (if necessary, fill it will antifreeze).

10.2 Storage

The hemodialysis device must be stored upright in a well-ventilated


room with little variations in temperature.

Storage temperature Storage temperature:

without antifreeze +5 °C to +60 °C


with antifreeze –20 °C to +60 °C

Relative humidity 30 % to 75 %, temporarily 95 %

Antifreeze When storing the hemodialysis device with antifreeze, make sure to use
antifreeze of the following composition:
48.75 % water, 48.75 % glycerin, 2.5 % Teta-Plus
or
49.875 % water, 49.875 % glycerin, 0.25 % ClearSurf™

Charging the integrated Upon receipt of the hemodialysis device, the integrated batteries must
batteries be charged as follows:
– Connect the device to the external power supply by means of the
power cable.
– Then turn the device on for approx. 10 hours.
If the device is not used, this procedure should be repeated every six
months.

10-2 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 10: Transport / storage

10.3 Environmental compatibility and recycling

Only environmentally compatible and recyclable materials are used for


the manufacture of the device and the consumables.
Within the EC member states the device is taken back in accordance
with directive 2002/96/EG (WEEE). Please also observe the applicable
local legal regulations.
The device and the consumables are generally considered to be
contaminated and must therefore be sufficiently disinfected by the
responsible organization as specified by the manufacturer.
The respective regulations for the disposal of electronic scrap should be
followed for the disposal of electronic boards.
All batteries should be disposed of according to the respective
regulations.
Further information regarding disposal is available on request.

10.3.1 Material list

 Plastics

Description Use in dialysate


circuit

ABS

EPDM X

NBR

PA (PA 6.6)

PBT

PBT X

PBT/ABS GF 20

PC X

PC+ABS

PE

PE (soft)

PEEK X

PES X

Polyester

POM

PP X

Fresenius Medical Care 4008 S OP-EN 4/12.10 10-3


Chapter 10: Transport / storage

Description Use in dialysate


circuit

PP-H X

PP(E)

PPO X

PPS X

PPSU X

PS

PSU

PTFE X

PUR

PVC

PVDF X

Silicone SIK X

Silicon tubing X

TPE

VMQ SI (Q)

Silicone X

TEEE

CM/ EPDM-L

EPDM

 Metals / glass

Description Use in dialysate


circuit

Graphite X

Glass X

Aluminum

Sheet copper

Sheet steel

Aluminum sheet

St37K

1.4300

10-4 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 10: Transport / storage

Description Use in dialysate


circuit

1.4301

1.4305

1.4401 X

1.4404/1.4435 X

Spring steel 1.4568

Titanium X

Spring steel 1.4310

Fresenius Medical Care 4008 S OP-EN 4/12.10 10-5


Chapter 10: Transport / storage

 Miscellaneous – various materials

Description Use in dialysate


circuit

Radox

Lexan (plexiglass)

Oxit 100

Steel 1.1121

Steel, cadmium-plated and chrome-plated

MS 58

MS 63

Leather (bag)

Nylon 6/6 UL 94 V-2

Paper

Perlon D536/20 (roller blind strap)

Silpad 400

Thermally conducting paste

Synchroflex (toothed belt)

Sirex PU foam (insulating boards),


open-pored, adhesive on one side

Ceramics X

 Miscellaneous - adhesives

Description Use in dialysate


circuit

Loctite

Scotch-Weld DP 460

Scotch-Weld V 23

Cyanolit

Elastosil

3 M Scotch Weld
EPXDPU60

10-6 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 10: Transport / storage

 Miscellaneous - lacquers

Description Use in dialysate


circuit

Enamel: Pehapol

Base: Epoxy resin

Prime Coat:
P 81.914 (base)

Hardener: P 85.033 (PUR)

Insulating lacquer: Type FS 190

Dilution: Type FS 225

Screening lacquer: Elektro DAG 438/


Fa. Acheson

 Miscellaneous - packaging

Description Use in dialysate


circuit

Ethafoam (polystyrene)

Corrugated cardboard

Cellular rubber

Wooden pallet

 Electrical equipment

Description Assembly type Use in dialysate circuit

Copper, cast steel, cast zinc Motors

Copper, polyester/polyurethane Transformers


Potting compound PU 151/20, UP resin,
Iron core

Copper + tin, Plug connectors


glass fiber enforced thermoplastics

P.C.B. base material, glass fiber enforced Electronic components


thermoplastics
Ferrite cores, Lithium batteries, lead-acid battery

Copper, PVC, Teflon Cables

Fresenius Medical Care 4008 S OP-EN 4/12.10 10-7


Chapter 10: Transport / storage

10-8 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 11: Technical Safety Checks / maintenance

11 Technical Safety Checks / maintenance

11.1 Important information

Checks The Technical Safety Checks must be performed every 24 months.

Tester's qualification The checks of the device should be performed by the


Fresenius Medical Care technical customer service or a person
authorized by them.
The checks must only be carried out by persons, who, based on their
training, knowledge and on-hand experience, are qualified to carry out
such checks in a proper manner. Furthermore, the persons, who carry
out the checks, may not be subjected to outside instructions with
regards to these checks.

Specifications The technical specifications must be adhered to.

Documentation The Technical Safety Checks, the maintenance procedures and further
explanations on the implementation can be found in the Service
Manual.
Reports can be provided, if desired.
Performance of the Technical Safety Checks must be recorded in the
Medical Device Register.

Caution
When the device is recommissioned, check that the pressure of the
water supply complies with the prescribed minimum pressure.

Fresenius Medical Care 4008 S OP-EN 4/12.10 11-1


Chapter 11: Technical Safety Checks / maintenance

11-2 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 12: Specifications

12 Specifications

12.1 Dimensions, weight and housing material

Dimensions Height: approx. 137 cm (without IV pole)


Width: approx. 48 cm
Depth: approx. 48 cm (without housing foot)
Base: approx. 48 x 63 cm2

Weight Approx. 86 kg (without options)

12.2 Electrical safety

Electrical safety (classification according to EN 60601-1, IEC 601-1)

Type of protection against Safety class I


electrical shock

Degree of protection type B


against electric shock:

Protection against ingress drip-proof


of liquids

Leakage currents See TSC

12.2.1 Guidance and manufacturer’s declaration for EMC (IEC 60601-1-2:2001)

Guidance and manufacturer’s declaration - Electromagnetic emissions


The 4008 S hemodialysis device is intended for use in the electromagnetic environment specified below. The
customer or the user of the 4008 S hemodialysis device should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1 The 4008 S hemodialysis device uses RF energy only for its
internal function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby electronic
equipment.
RF emissions CISPR 11 Class B The 4008 S hemodialysis device is suitable for use in all
Harmonic emissions Class B establishments, including domestic establishments and those
IEC 61000-3-2 directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Voltage fluctuations / Complies
flicker emissions
IEC 61000-3-3

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Chapter 12: Specifications

Guidance and manufacturer's declaration – Electromagnetic immunity


The 4008 S hemodialysis device is intended for use in the electromagnetic environment specified below. The
customer or the user of the 4008 S hemodialysis device should assure that it is used in such an environment..
Immunity test IEC 60601 test level Compliance level Electromagnetic environment –
guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or
discharge (ESD) ±8 kV air ±8 kV air ceramic tile. If floors are covered with
IEC 61000-4-2 synthetic material, the relative humidity
should be at least 30 %.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that of a
transient/burst supply lines supply lines typical commercial and/or hospital
IEC 61000-4-4 ±1 kV for input/output Not applicable environment.
lines
Surge IEC 61000-4-5 ±1 kV differential ±1 kV differential Mains power quality should be that of a
mode mode typical commercial and/or hospital
±2 kV common mode ±2 kV common mode environment.
Voltage dips, short <5 % UT (>95 % dip <5 % UT (>95 % dip After power supply interruptions, the
interruptions and in UT) for 0.5 cycle in UT) for 0.5 cycle battery of the 4008 S hemodialysis device
voltage variations on 40 % UT (60 % dip in 40 % UT (60 % dip in takes over the supply without delay.
power supply input UT) for 5 cycles UT) for 5 cycles
lines IEC 61000-4-11
70 % UT (30 % dip in 70 % UT (30 % dip in
UT) for 25 cycles UT) for 25 cycles
<5 % UT (>95 % dip <5 % UT (>95 % dip
in UT) for 5 sec in UT) for 5 sec
Power frequency (50 3 A/m 3 A/m Power frequency magnetic fields should be
/ 60 Hz) magnetic at levels characteristic of a typical location
field IEC 61000-4-8 in a typical commercial or hospital
environment.
Note: UT is the a.c. mains voltage prior to application of the test level.

12-2 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 12: Specifications

Portable and mobile RF communications


equipment should be used no closer to any
part of the 4008 S hemodialysis device ,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance:
Conducted RF 3 Vrms 3V d = 1.2 P
IEC 61000-4-6 150 kHz to 80 MHz 150 kHz to< 80 MHz
Radiated RF 3 V/m 3 V/m d = 1.2 P
IEC 61000-4-3 80 MHz to 2.5 GHz 80 MHz to <800 MHz
d = 2.4 P
800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey, a should be less than the
compliance level in each frequency range
b.

Interference may occur in the


vicinity of equipment marked with
the following symbol.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
4008 S hemodialysis device is used exceeds the applicable RF compliance level above, the 4008 S
hemodialysis device should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the 4008 S hemodialysis device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Fresenius Medical Care 4008 S OP-EN 4/12.10 12-3


Chapter 12: Specifications

Recommended separation distances between portable and mobile RF telecommunication devices and
the hemodialysis device 4008 S
The 4008 S hemodialysis device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the 4008 S hemodialysis device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the 4008 S hemodialysis device as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter m
power of transmitter 150 kHz to < 80 MHz 80 MHz to <800 MHz 800 MHz to 2.5 GHz
W d = 1.2 P d = 1.2 P d = 2.4 P
0.01 0.12 0.12 0.24
0.1 0.38 0.38 0.76
1 1.2 1.2 2.4
10 3.8 3.8 7.6
100 12 12 24
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

12.3 Electrical supply

Line voltage 100 V AC, ±10 %, 47 to 63 Hz, 16 A


110 V AC, ±10 %, 47 to 63 Hz, 15 A
120 V AC, ±10 %, 47 to 63 Hz, 14 A
127 V AC, ±10 %, 47 to 63 Hz, 14 A
220 V AC, ±10 %, 47 to 63 Hz, 9 A
230 V AC, ±10 %, 47 to 63 Hz, 9 A
240 V AC, ±10 %, 47 to 63 Hz, 9 A
(he decisive criterion is the line voltage and operating current specified
on the type label of the device.)

Power supply (internally) +5 V, +0.3 V, (short-circuit resistant)


+12 V, +0.4 V, (short-circuit resistant)
+24 V, ±0.7 V, (short-circuit resistant)

Battery Lead-acid battery (maintenance-free)


18 V, 3 Ah

12-4 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 12: Specifications

12.4 Type label (identification of the device)

The type label shown is only an example. The decisive criterion is the
data specified on the type label of the device.

1 Equipment Code
2 Identification of electric and electronic devices
3 Degree of protection against electrical shock: type B
4 CE Mark
5 Manufacturer with date of manufacture as year digit
6 Protection against ingress of liquids: Drip-proof
7 Connection values
8 Serial number
9 Type identification

12.5 Fuses

Battery 1 x T 3.15 A; Power supply unit, Fuse in housing foot (rear)/SI5

Fresenius Medical Care 4008 S OP-EN 4/12.10 12-5


Chapter 12: Specifications

12.6 Operating conditions

Water inflow pressure 1.5 up to 6.0 bar

Water inflow temperature 5 °C to 30 °C


for "integrated hot rinse“: 85 °C to 95 °C

Water inflow rate 1.3 l/min; at an inlet pressure of 1.5 bar

Water drain 0 to 100 cm above the ground; each dialysis device must be provided
with its own free fall air gap of at least 2 cm. The water drain must be
positioned lower than the dialyzer.

Concentrate supply 0 to –100 mbar; max. suction height 1 m, max. height of fall 0 m
(for central concentrate supply 0 to 500 mbar)

Heat dissipation Dialysis: approx. 400 watts (at an ambient temperature of 20 °C)
Hot rinsing: approx. 520 watts (at an ambient temperature of 20 °C)

Operating temperature 15 °C to 35 °C
area

Atmospheric pressure 700 hPa up to 1060 hPa

Relative humidity 30 % to 75 %, temporarily 95 %

IV pole pressure Maximum 5 kg

Temporary downtime Prior to the downtime, it is recommended to carry out a hot rinse
program without a cooling rinse (PGM 2) and a disinfection prior to
commencing operations.

12.7 Storage conditions

Transportation and In both cases, the device must be filled with antifreeze containing
storage disinfectant. Composition:
48.75 % water, 48.75 % glycerin, 2.5 % Teta-Plus
or
49.875 % water, 49.875 % glycerin, 0.25 % ClearSurf™

Frost resistance Down to approx. –20 °C

Storage temperature –20 °C to +60 °C (with antifreeze)


+5 °C to +60 °C (without antifreeze)

Charging the integrated Upon receipt of the hemodialysis device, the integrated batteries must
batteries be charged as follows:
– Connect the device to the external power supply by means of the
power cable.
– Then turn the device on for approx. 10 hours.

12-6 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 12: Specifications

If the device is not used, this procedure should be repeated every six
months.

12.8 External connection options

Caution
Additional equipment connected to medical electrical equipment must
comply with the respective IEC or ISO standards (e.g.(DIN) EN 60950
or IEC 60950 for data processing equipment). Furthermore all
configurations shall comply with the requirements for medical electrical
systems (see IEC 60601-1-1 or clause 16 of the third edition of
IEC 60601-1, respectively).
Anybody connecting additional equipment to medical electrical
equipment configures a medical system and is therefore responsible
that the system complies with the requirements for medical electrical
systems. Attention is drawn to the fact that local laws take priority over
the above mentioned requirements. If in doubt, consult your local
representative or the technical service department.

Network Network (option) interface

Input / output For connection of external auxiliary equipment.


(maximum 24 V/24 W)

Alarm in Can be used for the connection of an external pushbutton switch


(Alarm input) (normally open contact). This button can be used to initiate an alarm.

Alarm out Potential-free alarm output. Alternating contact (maximum 24 V/24 W)


(Alarm output)
For connection of an external alarm indicator (lamp). (Nurse call)
Connection by means of a 5-pin diode plug (stereo 180°) via a shielded
line. Shield grounded on either side.

Diagnosis For inhouse computer diagnosis

12.9 Override conditions

Audible alarm suppression Mute alarm time: adjustable in the SETUP menu from 1 to 2 minutes
(Factory setting: 1 minute).
Any new alarm reactivates the silenced audible alarm.

Blood leak override Override time: 2 minutes.

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Chapter 12: Specifications

Alarm override The key Start/Reset overrides:


– an arterial and venous pressure alarm for approx. 8 seconds
– a blood leak alarm for approx. 8 seconds
– a TMP alarm for approx. 2 minutes (time determined by the UF
coefficient).
When overriding a safety system, the responsibility for the patient’s
safety rests with the operator of the device.

12.10 Operating programs

T1 test Automatic test for checking the safety systems. Must be started prior to
each dialysis treatment. The T1 test is mandatory
– After a start with external power supply (not power failure)
– After one of the cleaning programs.

Preparation Defined by the optical detector below the venous bubble catcher.
As soon as blood is detected by the optical detector the preparation
phase is terminated.

Priming the blood lines Automatic priming of the blood lines after pressing a key (Prime).
Priming is automatically terminated as soon as the venous bubble
catcher is filled, however, not later than after 1 to 5 minutes (time
adjustable in the SETUP menu).

Dialysis Acetate dialysis or bicarbonate dialysis

Sequential ultrafiltration Ultrafiltration without dialysate flow / ISO-UF (Bergström process)

Single-Needle Click-Clack With arterial and venous line clamp; pressure-pressure controlled with
dialysis adjustable pressure reverse values. An emergency procedure in case
of problems with the vascular access during Double-Needle dialysis.

Single-Needle dialysis Two-pump procedure with adjustable upper pressure (adjustable via
(option) stroke volume).

Cleaning programs Rinse and chemical disinfection:


Time adjustable in the SETUP menu, temperature: approx. 37 °C, flow:
600 ml/min
Hot rinse / hot disinfection / integrated hot rinse:
Time adjustable in the SETUP menu, temperature: approx. 84 °C, flow:
450 ml/min
Timer counter stops in the event of a lower temperature alarm.
In all cleaning programs:
The blood pumps stop, the venous line clamp is closed.
The program run (timing) is interrupted by a flow alarm.
The cleaning programs can be prematurely terminated.
The chemical disinfection program is followed by a mandatory rinse.

12-8 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 12: Specifications

12.11 Dialysate circuit and safety systems

Blood leak detector Threshold of response less than or equal to 0.5 ml blood loss per minute
to the dialysate at a hematocrit of 0.25.
(Flow rate 300 ml/min up to 800 ml/min)
With the dialysate flow turned off, a blood leak alarm response is
delayed. The delayed response is dependent upon the fluid volume in
the hydraulic compartment between dialyzer and blood leak detector
(approx. 110 ml total fluid volume )as well as upon the size of the
membrane rupture in the dialyzer. The response of a blood leak alarm
is, in addition, dependent upon the set ultrafiltration rate.

Transmembrane pressure Display range: –60 up to 520 mmHg


Resolution: 20 mmHg
– The OD in the air detector senses light: Alarm window width: wide
window, upper and lower LED
– The OD in the air detector senses dark: Alarm window width:
dependent on the UF coefficient
During dialysis the TMP will drift within certain limits due to the change
in blood viscosity caused by fluid removal. To maintain the monitoring
sensitivity without creating nuisance alarms, the TMP alarm limits will
track up to a maximum of 120 mmHg.
SN click-clack: Limits extended by ±10 mmHg
TMP measuring equipment with adjustable limits.
Definition TMP = Pbo – Pdo + Offset
TMP = transmembrane pressure
Pbo = blood pressure on the outlet side of the dialyzer
Pdo = Dialysate pressure on the outlet side of the dialyzer
Offset = correction of flow-dependent pressure drops

Ultrafiltration Selectable UF rate: 0.00 l/h up to maximum rate


Resolution: 1 ml/h
Pump volume precision: ±1 %
Maximum rate internally adjustable to 1, 2, 3, or 4 l/h
Safe condition: pressure equalization via the dialyzer membrane,
ultrafiltration = 0

Cyclic pressure holding V24 and V24b closed; bypass operation


test
Activated every 12.5 minutes for 8 seconds on the outlet side of the
dialyzer.

Balancing Accuracy:
±0.1 % according to the total dialysate volume

Maximum balancing error F = FUF + FBil


F= maximum balancing error
FUF = Ultrafiltration error
FBil = Balancing error

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Chapter 12: Specifications

Example:
Ultrafiltration error: at 1000 ml in 1 hour: ±1 % = ±10 ml/h
Balancing error: 30 liters dialysate flow in 1 hour with a dialysate flow of
500 ml/min:
±0.1 % = ± 30 ml/h
Maximum balancing error:
F = FUF + FBil = (±10 ml/h) + (±30 ml/h) = ±40 ml/h

Degassing Residual gas volume in the dialysate at the inlet to the dialyzer approx.
11 ml air per 1 liter of water (at 1000 hPa and 0 °C)
When operating with reverse osmosis water of 22 °C and an air content
of approx. 21 ml air per 1 liter water (at 1000 hPa and 0 °C)
Method: negative pressure

Dialysate concentration Display range: 12.8 to 15.7 mS/cm


(conductivity)
Resolution: 0.1 mS/cm
Accuracy: 0.1 mS/cm
Alarm window width:
– If OD senses light or dark fluid with the dialysate couplings attached
to the dialyzer:
0.8 mS/cm (< ±5 % around the actual value)
– If OD senses dark and the dialysate couplings are in the shunt
interlock:
upper and lower LED
Alarm window position:
12.8 to 15.7 mS/cm (entered in SETUP)
Temperature-compensated electronic conductivity meter with
adjustable alarm limits.
– Acetate:
Standard setting 1+34
(Other mixing ratios can be selected in the SETUP menu).
Selectable range: 125 to 150 mmol/l, depending on the concentrate
used.
Volumetric proportional mixing system. The rated concentration is
achieved within 10 minutes.
– Bicarbonate:
Normal setting 1+27.6,
Adjustment range: ±8 mmol/l
– bibag® :
Bicarbonate concentrate preparation from the bibag®
Temperature range: 15 to 35 °C

Temperature – Dialysate temperature as well as rinse and chemical disinfection


temperature:
– Selectable range:
Dialysis: (Rates temperature) 35.0 °C to 39.0 °C
Cleaning programs: 37 °C
Resolution: 0.5 °C
Measuring accuracy: ±0.5 °C
Alarm window width:

12-10 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 12: Specifications

Dialysis: 33.0 °C and 40.0 °C


Cleaning programs: 33 °C and 41 °C
Temperature measuring equipment independent of regulation and
provided with limits. During each T1 test, it is checked whether
switching into the safe state (bypass operation) is performed. The
rated temperature is achieved not later than after 10 minutes.
– Hot rinse temperature:
Display range (text display): 72 °C to 99 °C
Rated temperature: 84 °C
Resolution: 1 °C
In the program hot rinse, the time starts counting once 80 °C are
reached.
In case of error, the heating is switched off at 90 °C.

Flow – Dialysate flow:


Rated values: 300, 500, 800 ml/min.
Accuracy:
Flow: ±10 %
Measurement by means of time pulse monitoring
– Rinse and disinfection flow:
Rated value: 600 ml/min
– Hot rinse flow:
Rated value: 450 ml/min
– Flow alarm:
Value is more than 20% below rated value.
– In case of water shortage:
Visual alarm, heater turned off,
only if the OD in the AD senses dark fluid: audible alarm

DIASAFE® plus Filter service life: Maximum of 12 weeks or 11 degreasing programs.


The service life is monitored by the dialysis device and a warning (filter
change) is displayed.

OCM Function OCM conductivity evaluation: 12 bit with 2 channels


– Measuring range: 12.8 – 15.7 mS/cm
– Measuring accuracy: 0.05 mS/cm
OCM temperature evaluation: 12 bit with 2 channels
– Measuring range: 33.5 – 41 °C
– Measuring accuracy: 0.2 °C

Caution
The measurement data for the conductivity measurement section (CD
cell before or after the dialyzer) serve to evaluate and calculate the
clearance parameters, Kt/V and plasma Na+ and have no relevance for
the safety.

Fresenius Medical Care 4008 S OP-EN 4/12.10 12-11


Chapter 12: Specifications

12.12 Extracorporeal blood circuit and safety systems

 Arterial range

Arterial pressure Display range: –300 up to +280 mmHg


measurement Resolution: 20 mmHg
Accuracy: 10 mmHg
The OD in the air detector senses light:
Alarm window width: –300 up to +280 mmHg
The OD in the air detector senses dark:

Alarm window width: 120 mmHg,


can be adjusted anywhere in the display
With Single-Needle dialysis as well as with Single-Needle Click-Clack
dialysis:
The OD in the air detector senses either dark or light; upper limit fixed
to 280 mmHg; lower limit adjustable from 0 up to –300 mmHg.
Monitoring of the arterial pressure.

Blood pump (arterial) Delivery rate: 15 to 600 ml/min


Resolution: 5 l/min; at a line diameter of 8 mm)
Accuracy: ±10 %
Line diameter: 2 to 10 mm
Resolution: 0.2 mm
Blood pump stop alarm: 15, 30 seconds
(factory setting: 30 seconds)
Spring-loaded rollers, fully occluding, pressure-limited to 2.7 bar. (when
using the prescribed blood lines).
A change in the direction of rotation of the blood pump is electrically
excluded. (Due to its construction – grip shell on rotor –, the blood pump
can be operated manually in clockwise direction only.)

Blood pump (SN) Stroke volume: 10 to 50 ml (factory setting 30 ml)


(Optional): Resolution: 5 ml
Technical data same as specified for the arterial blood pump
Pressure transducer for Single-Needle operation: pressure reversal.

Heparin pump Delivery rate: 0.1 up to 10 ml/h


Resolution: 0.1 ml/h
Accuracy:
±5 % for delivery rates 1 to 10 ml/h and a measurement time of 2 hours
up to 1.2 bar counter-pressure.
Calibrated for 20 ml B&D Plastipak syringes Fresenius no.: 503 034 1
For delivery rates of <1.0 ml/h, the tolerance may be exceeded by ±5 %.
Stop time: 0 min. to 2 hours
Resolution: 1 min.
Bolus dose: 0.1 up to 5.0 ml
Resolution: 0.1 ml
Maximum cumulated bolus dose: 1x syringe capacity

12-12 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 12: Specifications

 Venous range

Venous pressure Display range: –60 up to +520 mmHg


measurement Resolution: 20 mmHg
Accuracy: 10 mmHg
The OD in the air detector senses light:
Alarm window width: –60 up to +520 mmHg
The OD in the air detector senses dark:
Alarm window width: 40 up to 200 mmHg
adjustable in the display from -60 to 520 mmHg (if "Ven. window
position ON" is activated in the SETUP)
With Single-Needle click-clack dialysis:
Alarm window width:
80 to 460 mmHg, adjustable from 20 to 480 mmHg
Monitoring of the venous back pressure.

Air detector Threshold of response: drop in the fluid level, air bubbles, froth or micro
bubbles (blood/air mixture) over the entire blood flow range from 0 up to
600 ml/min.
An alarm is activated when 5 ml of air with a volume flow of 600 ml/min
is detected.
The indication of the air volume here refers to micro bubbles with a
diameter <10 µm when using the blood lines approved for the device.
Method: ultrasonic transmission

 Audible alarm

Selectable range for the audible alarm's sound pressure level:


Adjustable with the volume control on the rear of the monitor,
minimum setting: 65 dBA

Fresenius Medical Care 4008 S OP-EN 4/12.10 12-13


Chapter 12: Specifications

12-14 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 13: Definitions

13 Definitions

13.1 Definitions and terms

Terms used in these Operating Instructions are explained in the following.

Arterial pressure Pressure in the extracorporeal circuit between arterial cannula and
blood pump.

Purified water Water suitable for hemodialysis (e.g. water purified by reverse
osmosis).

Bubble catcher Device integrated in the blood lines for separating gases which are not
dissolved in the blood.

Blood alarm Group of alarms which cause the blood systems to stop:
– Arterial pressure
– Venous return pressure
– Transmembrane pressure
– Blood leak
– Air
– BP stop alarm

Blood systems Systems which maintain and control the function of the extracorporeal
circuit.

Bypass Process during which the dialysate is diverted away from the dialyzer.

Dialyzer blood connection Arterial or venous blood connection port provided at the dialyzer.

Dialysate The replacement fluid used in dialysis.

Dialysate pressure The pressure present in a defined section of the system carrying the
dialysate, e.g. at the dialyzer outlet.

Pressure measurement Connector for the pressure measurement line, e.g. Luer-lock.
port

Pressure measurement Line connecting the blood lines with the pressure monitoring unit.
line

Compliance chamber Device for leveling variations in pressure and volume, e.g. in the Single-
Needle mode.

Extracorporeal circuit A section of the blood circulation which takes place outside of the body.

Conductivity Reciprocal specific electrical resistance, e.g. dialysate.

Pump head The pump head comprises pump rotor and pump stator.

Pump rotor Driven part of the pump head.

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Chapter 13: Definitions

Pump segment Line segment which is inserted into the pump head.

Pump segment holder Device for fixing the blood pump segment.

Pump stator Stationary support for the pressure pulleys of the pump rotor.

Occlusion clamp Device for automatically clamping the blood lines, e.g. in the event of
alarms or during Single-Needle operation.

Sequential therapy (ISO- The hemodialysis treatment is divided into two successive treatment
UF) phases during which either only ultrafiltration or ultrafiltration and
diffusion are performed (Bergstroms technique).

Single-Needle method Technique in which the vascular access for the treatment procedure is
established by means of only one puncture.

Transmembrane pressure Difference between the pressures acting upon the dialyzer membrane
(blood pressure, pressure in the dialysate).

Venous return pressure Pressure in the extracorporeal circuit before the venous cannula (e.g.
in the venous bubble catcher).

Water alarms Group of alarms which do not cause the blood systems to be stopped:
Conductivity (bypass operation), temperature (bypass operation), flow.

13.2 Abbreviations

AC Alternating current

AD Air detector

BC Balancing chamber

BIC Bicarbonate

BP Blood pump

CD Conductivity

CDS Central Delivery System

DC Direct current

Fig.: Figure (diagram)

HD Hemodialysis

HDF Hemodiafiltration

LED Light emitting diode

OCM Online Clearance Monitoring

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Chapter 13: Definitions

OD Optical detector

SI Shunt interlock

SN Single-Needle

SV Solenoid valve

TMP Transmembrane pressure

UF Ultrafiltration

13.3 Symbols

Caution

Refer to instruction manual/booklet

Manufacturer with date of manufacture as year digit


YYYY

Serial number

IPX1 Protection against ingress of liquids:


Drip-proof (IPX1)

Degree of protection against electric shock:


Type B

Alternating current

Protective conductor terminal

Ground / system ground

Equipotentiality

I/O ON / OFF

Start of a specific procedure

Dangerous electrical voltage

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Chapter 13: Definitions

Disconnect the power plug before opening

Heat radiation

Do not reuse
2
Use by

Batch code
LOT

Date of manufacture

Quantity

Identification of electric and electronic devices

Transmitter

Risk of caustic burning

Elevated surface temperature

13.4 Literature

Hemodialysis in General – Franz, H.E.: “Blutreinigungsverfahren”, Technik und Klinik;


Hemodialysis; peritoneal dialysis, CAPD, hemofiltration,
hemodiafiltration, hemoperfusion, membrane plasma separation;
2nd revised edition / 1991 Georg Thieme Verlag Stuttgart – New
York; 1st edition 1973, under the title: „Praxis der
Dialysebehandlung“; ISBN 3 13 497702 8.

13-4 Fresenius Medical Care 4008 S OP-EN 4/12.10 )


)
)
)
Chapter 13: Definitions

Dialysate filter Publications, studiest on polysulfone membranes, with the enclosed


literature references.
– “No evidence for endotoxin transfer across high flux polysulfone
membranes”, among others by Professor Dr. med. Jürgen Bommer
from the Ludolf-Krehl-Klinik in Heidelberg.
– “Filtration of dialysate using an ON-LINE dialysate filter”, dated June
5, 1990, among others by Francise Dumler MD, Division of
Nephrology & Hypertension, Henry Ford Hospital, 2799 West Grand
Blvd., Detroit, MI, 48202, USA as well as Fresenius brochures on
DIASAFE and polysulfone high-flux with literature.
– “Hemodiafiltration with ON-LINE Production of Bicarbonate Infusate:
a new standard for high efficiency, low-cost dialysis in elderly and
uncompliant patients” among other by Dr. B. Canaud, Division of
Nephrology, Lapeyronie University Hospital, 555, Route de Ganges,
34059 Montpellier, France.

Online Clearance – Marcelli D, Stannard D, Conte F, Held PJ, Locatelli F, Port FK:
Monitoring (OCM) ESRD patient mortality with adjustment for comorbid conditions in
Lobardy (Italy) versus the United States. Kidney Int 50 (1996).
– Gotch FA, Sargent JA. A mechanistic analysis of the National
Cooperative Dialysis Study. Kidney Int 28, 524 – 34, 1985.
– Levin NW, Standard DC, Gotch F, Port FK: Comparison of mortality
risk by Kt/V single pool vs double pool: analysis in diabetic and in
non diabetic patients (abstract). J Am Soc Nephrol 6: 606 (1995).
– Pedrini LA, Zereik S, Rasmy S. Cause: kinetic and clinical
implications of post-hemodialysis urea rebound. Kidney Int 34: 817
– 24, 1996.
– Dephner TA, Keshaviah PR, Ebben JP, Emerson PF, Collins AJ,
Jindal KK, Nissenson AR, Lazarus JM, Pu K: Multicenter clinical
validation of an online monitor of dialysis adequacy. J Am Soc
Nephrol 7: 464 – 71, 1996.

– Polaschegg HD: Automatic, noninvasive intradialytic clearance


measurement. Int J Artif Organs 16: 185 – 91, 1993.
– Babb AL et al.: Chem Eng Prog Symp Ser 84: 59 – 68, 1968.
– Petitclerc T, Goux N, Reynier AL, Béné B: A model for non-invasive
estimation of in vivo dialyzer performances and patient's conductivity
during hemodialysis. Int J Artif Organs 16: 585 – 91, 1993.
– Petitclerc T, Béné B, Goux N, Deray G, Jabobs C: A real-time
noninvasive and automatic measurement of Kt/V during
hemodialysis session. J Am Soc Nephrol 4: 376, 1993.
– Petitclerc T, Béné B, Jabobs C, Jaudon, Goux N: Non-invasive
monitoring of effective dialysis dose delivered to the haemodialysis
patients. Nephrol Dial Transplant 10: 212 – 6, 1995.
– Manzoni C, Di Filippo S, Corti M, Locatelli F: Ionic dialysance as a
method for the on-line monitoring of delivered dialysis without blood
sampling. Nephrol Dial Transplant 1996 (in press).
– Gotch F, Peter H, Panlilio F, Folden T, Keen M: On-line
measurement of delivered Kt/V during dialysis (Abstract). J Am Soc
Nephrol 6: 600, 1995.
– Lowrie EG et al.: Kidney Int 23 (Suppl 13): 11 – 8, 1983.
– Panzetta, Int J Artif Organs 18: 530 – 33, 1995.
– Steil et al.: American Society for Artificial Internal Organs Journal,
July – Sept. 1993, Vol. 39.

Fresenius Medical Care 4008 S OP-EN 4/12.10 13-5


Chapter 13: Definitions

13.5 Certificate

13.5.1 EC certificate

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Chapter 13: Definitions

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Chapter 13: Definitions

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Chapter 13: Definitions

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Chapter 14: Options

14 Options

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Chapter 14: Options

14.1 Single-Needle dialysis

Caution
Preventing contamination:
To prevent cross-contamination only use blood lines with hydrophobic
filters connected to the pressure lines. If a hydrophobic filter has
become wet, the blood lines must be replaced.
On blood lines with additional connection sites, a replacement pressure
measurement line may be connected (accessory available from
Fresenius Medical Care).
If the pressure measurement unit is contaminated, all affected parts
must be disinfected or replaced.

14.1.1 Preparation

Preparation and setting of the delivery rate (see chapter 4.1.6.1, page 4-19).

2 1. Place the compliance chamber into the


holder below the blood pumps.
2. Connect the Single-Needle pressure
transducer.

Note
Do not install the Single-Needle pump segment!

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Chapter 14: Options

14.1.1.1 Setting the stroke volume when using a Single-Needle blood pump

Rate: ml/h (Ø:ml) Press the  key and the Start/Stop key
simultaneously on the Single-Needle Blood
Start key pad.
Stop

The stroke volume is displayed in ml.

Rate: ml/h (Ø:ml) Use the  key or the  key to select the
desired stroke volume.
Start
Selectable range: 10 to 50 ml in
Stop
increments of 5 ml.

Rate: ml/h (Ø:ml) Press the Start/Stop key on the Single-


Needle bloodpump key pad.
Start
The delivery rate will display after
Stop approx. 2 seconds.

14.1.1.2 Connecting the patient

Rate: ml/h (Ø:ml) Press the Start/Stop key on the arterial blood
pump.
Start
The Operation (green) LED is dark.
Stop
The arterial blood pump stops.

Connect the arterial line to the patient.


Connect also the venous line if the saline in
the blood line is to be given to the patient.

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Chapter 14: Options

Rate: ml/h (Ø:ml) Press the  key and the  key to set the
delivery rate on the arterial blood pump.
Start
Stop

Insert the Single-Needle pump segment of


the blood lines into the Single-Needle blood
pump.

Rate: ml/h (Ø:ml) Press the  key and the  key to set the
delivery rate on the Single-Needle blood
Start pump.
Stop
It is recommended to select a delivery
rate for the Single-Needle blood pump
that is 10 – 15 % higher than arterial
blood pump.

Press the SN key.


The SN LED is illuminated.

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Chapter 14: Options

Rate: ml/h (Ø:ml) Press the Start/Stop key on the arterial blood
pump.
Start
Stop The Operation (green) LED of the blood
pump is illuminated.
The blood pumps are delivering
(provided there is no blood alarm)

The optical detector senses dark.


Status indicator light turns yellow
(warning/info).

Display message
Preparation end
The alarm limits (arterial, venous, TMP and
conductivity) are set automatically.
The blood pump stops.
The venous line clamp closes.
Audible signal

The Start/Reset LED is flashing.


The Mute LED is flashing.
Connect the venous line to the patient (unless
this has already been done).

Check the level in the venous bubble catcher


and adjust, if necessary.
Only possible when the Single-Needle
blood pump is rotating.

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Chapter 14: Options

Press the Start/Reset key.


The Start/Reset LED is illuminated.
The blood pumps are started automatically.

SN Dialysis
Display message

Note
When performing Single-Needle dialysis, it is important to dialyze with
maximum blood flow.

14.1.1.3 End of treatment

Status indicator light turns yellow


(warning/info).

UF goal reached
Display message, e.g. UF goal reached

Rate: ml/h (Ø:ml) Stop the arterial or the Single-Needle blood


pump.
Start
Stop

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Chapter 14: Options

1. Open the cover.


2/4
2. Press the Start/Stop key and keep it
pressed until the rotor stops.
3. Remove the line segment on the left.

1/6 4. Press the Start/Stop key and keep it


pressed until the line has been completely
removed.
5. Remove the line segment on the right.
6. Close the cover.

3
5

Press the SN key.


The SN LED turns dark.

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Chapter 14: Options

14.2 Option BPM (Blood Pressure Monitoring)

14.2.1 To be observed before using the BPM option

Caution
Only permitted accessories may be used (see chapter 8, page 8-1).
In order to obtain the best measurement results, it is necessary to
choose the correct blood pressure cuff for each use.
The blood pressure cuff must only be connected to the hemodialysis
device.
The BPM must not be used to carry out measurements on neonates or
infants.
The pressure tubing must not be bent or kinked.
While using the BPM, it must be checked, that the patient's blood
circulation is not limited by the blood pressure cuff for an extended
period of time. This is particularly the case when using the automatic
short-term repeated operation (quick).

Caution
Under no circumstances should the device be used as a substitute for
regular monitoring of the patient by the clinic staff.

14.2.2 BPM menu overview

5 2

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Chapter 14: Options

1 Status Indicator bottom field 4 Settings


Blue: Last measured value Presel. pressure(cuff pressure).
Yellow: Long-term interval active Interval Long-term interval measurement
Green: Measurement or quick mode active Possible settings: OFF or 5, 10, 15, 30, 45,
60 minutes)
2 Alarm limits
Upper and lower limits of the systolic, diastolic, 5 MONITOR
mean arterial pressure and pulse. SYS (systolic pressure)
DIA (diastolic pressure)
3 Quick (Short-term interval measurement)
MAP (mean arterial pressure)
Sequential measurements within a measurement
PULSE (heart rate)
time frame of approx. 5 minutes
Displays the actual values.
OFF: Quick mode off
As long as no valid measurement result exists,
START: Quick modus can be started
three lines are shown in place of each value.
ACTIVE: Quick mode on
If a preset value is either above or below, it is
displayed in yellow

With the BPM Start/Stop key on the monitor,


a blood pressure measurement can be
started and stopped.
With the BPM Menu key, the blood pressure
menu is activated.

With the arrow keys, the individual fields in


the menu are chosen.
With the keys 0–9 or keys +/–, the values are
entered.
With the Conf key the values are saved.
With the C key entered values can be
deleted.
With the Esc key the menu is exited without
saving the values.

14.2.3 Applying the blood pressure cuff

Caution
The blood pressure cuff should not be attached to limbs that are
connected to a vascular access (e.g. Shunt).
– When attaching the blood pressure cuff, be aware of the following:
To ensure that the blood pressure cuff does not move during the
measurement it must be positioned and connected correctly.

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Chapter 14: Options

Place the blood pressure cuff in a tight and


correct manner around the particular limb,
e.g. the upper arm. Please see the
illustrations "a" and "b". The blood pressure
cuff must be attached correctly and be in
contact with the skin at all times. The mark
must be positioned on the artery.

14.2.4 Checking / setting the inflation pressure / alarm limits

Caution
When setting the pump pressure, make sure that it is not set too high.

During the first measurement, the inflation pressure set by the operator
or the default value entered in SETUP will be used.
For all other measurements, the pump pressure of the BPM will be
automatically calculated from the last systolic pressure.
At any time the operator can manually adjust this pump pressure.
In the BPM menu
Check alarm limits for SYS, DIA, MAP, PULSE.
Set the desired parameters when required. Confirm the entered value
with the Conf key.
Check the confirmed values.

14.2.5 Starting the blood pressure measurement

During the measurement, the patient should not be left unattended, so


that the measurement can be discontinued immediately in case of
unforeseen operating conditions.
The following applies to all measurements:
A measurement lasts maximum 3 minutes.
A measurement is repeated a maximum of 3 times.

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Chapter 14: Options

14.2.5.1 Single measurement

Press the BPM Start/Stop key.


Status indicator green; shows the
current cuff pressure.

14.2.5.2 Interval (long-term interval measurement)

Press the BPM Menu key.


Use the Arrow keys to select the Interval
field.
Use the +/– keys to choose a time interval
and confirm using the Conf key
(5, 10, 15, 30, 45, and 60 min)

Use the BPM Start/Stop key to start the first


measurement.
Status indicator during the
measurement:
green

Status indicator during the


measurement:
yellow: The systolic and diastolic
pressure from the previous
measurement are displayed. No
measurement is being performed

Note
An interval measurement in progress will be deactivated by the start of
a cleaning program.

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Chapter 14: Options

Caution
In the interval mode, if a measurement is being performed it is possible
to stop it by pressing the BPM Start/Stop key without stopping the
interval mode. After the end of the cycle time, a new measurement is
activated.
In order to avoid further unintentional measurements, the interval mode
must be deactivated.

 Stopping the interval

Press the BPM Menu key.


Use the Arrow keys to select the Interval
field.
Select using the keys +/– OFF and confirm
using the Conf key.

14.2.5.3 Quick (short-term interval measurement)

Press the BPM Menu key.


Use the Arrow keys to select the Quick field.
Use the +/– keys to choose START.
Use the Conf key to start the Quick mode.
During the measurement:
The status indicator is green during the
measurement.
The BPM menu remains.
The limit values are grey and inactive.
In the Quick field, ACTIVE is shown.

After the measurement:


The status indicator is blue during the
measurement.
The systolic and diastolic pressure from
the previous measurement are
displayed.
In the Quick field, OFF is shown.
Maximum runtime: 5 min

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Chapter 14: Options

Note
The Quick mode can be stopped by pressing the BPM Start/Stop key.

14.2.6 Terminating / interrupting the blood pressure measurement

Caution
If it is not possible to stop the blood pressure measurement by pressing
the BPM Start/Stop key, then disconnect the pressure tubing from the
connection port on the BPM.

Press the BPM Start/Stop key.


Status indicator blue, the systolic and
diastolic pressures from the last
measurement are displayed

Caution
Check the blood pressure parameter for plausibility and patient setup.

14.2.7 Displaying graphics and blood pressure history

Different BPM graphics can be displayed in the Dialysis menu. The


options can be selected in the Dialysis representation menu.

 BPM data (sys / dia)

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Chapter 14: Options

The following is shown:


– Systolic pressure (sys) in mmHg (shown in red with X)
– Diastolic pressure (dia) in mmHg (shown in blue with +)
– Pulse per minute (1/min shown in black with o)

 BPM data (MAP)

The following is shown:


– Mean arterial pressure (MAP) in mmHg (shown in red with X)
– Pulse per minute (1/min shown in black with o)

 BPM History

Time Pulse

The following is shown:


– Measurement time
– Systolic pressure in mmHg
– Diastolic pressure in mmHg
– Mean arterial pressure (MAP) in mmHg
– Pulse per minute (1/min)
The last measured value is recorded at bottom of the list. If only one
diagram is chosen from the dialysis representation menu, the history
display is twice as high.

14.2.8 Specifications / general notes

The BPM (option) corresponds to the standard EN 1060-1 for non-


invasive blood pressure measurement devices, part 1, General
Requirements.

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Chapter 14: Options

1 Blood pressure cuff


2 Blood pressure cuff holder
1
3 BPM pressure connection
2 4 Pressure tubing

Only valid for the BPM Defibrillator-protected applied part, type CF


blood pressure cuff:
Degree of protection
against electrical shock

Blood pressure Display range:


– Systolic pressure: 30 mmHg up to 280 mmHg
– Diastolic pressure: 10 mmHg up to 240 mmHg
– MAP: 20 mmHg up to 255 mmHg
Resolution: 1 mmHg
Pressure pre-selection 100-290 mmHg

Blood pressure Maximum systematic measurement deviation:


measurement accuracy Systolic blood pressure: –0.9 mmHg
Diastolic blood pressure: –3.2 mmHg
Standard deviation in accordance with clinical test:
Systolic blood pressure: 6.4 mmHg
Diastolic blood pressure: 7.1 mmHg
BHS Grading:
systolic: C
diastolic: B
maximum measurement deviation for cuff pressure: 3 mmHg

Pulse Display range: 20 to 245 1/min


Resolution: 1/min

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Chapter 14: Options

14.2.9 Description of the BPM

 Operating principle

The module functions according to the oscillometric principle. The blood


pressure cuff is pumped up with an electrical pump. Finally, the
pressure in the blood pressure cuff is reduced step by step with the help
of the outlet valve. The pulse-contingent pressure changes in the blood
pressure cuff are are suppressed by the controlled pressure generated
by the pump and through the outlet valve.
The BPM control limits the maximum pressure of the blood pressure
cuff to 300 mmHg. An additional monitoring unit ensures immediate
deflation of the pressure if the pressure in the blood pressure cuff
exceeds 320 mmHg ± 10 mmHg.
The values of the blood pressure measurements are saved during the
Preparation phase, the Treatment and the Reinfusion phase. Up to
60 values can be displayed as graphics. The last 19 values can be
displayed as history.
It is not possible to carry out measurements during a filter change
(DIASAFE® plus).

Note
The BPM is electrically protected (isolated pressure tubing) which
protects the patient against burns when surgical equipment with high
frequency signals are used at the same time.

It is possible to use the BPM simultaneously with a defibrillator


(defibrillator-protected applied part of the type BF). The BPM's
functionality is not affected by the defibrillator discharge.

 Fields of application

It is possible to carry out the following blood pressure measurements


with the BPM:

Single measurement A single measurement is carried out by pressing the BPM Start/Stop
key. The BPM now performs a single blood pressure measurement. If
the blood pressure parameters cannot be determined, the process is
automatically repeated, or an error message appears (see
chapter 14.2.10, page 14-18).

Interval (long-term interval During the interval mode single measurements are performed at pre-set
measurement) time intervals. Time intervals can be set to 5, 10, 15, 30, 45 and
60 minutes. After the end of the cycle time, a new single measurement
is performed.
A single measurement in progress can be stopped. The interval mode
will remain active.
The interval mode can be deactivated in the BPM Menu.

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Chapter 14: Options

Quick (short-term interval The quick mode is used under extraordinary circumstances, where a
measurement) continual blood pressure measurement is required. The decision to
activate the quick mode may only be taken by qualified staff, as the
process places continuous pressure on the patient.
In quick mode, several single measurements are carried out
immediately after each other with reduced accuracy within a time frame
of 5 minutes.
The first measurement in quick mode corresponds to a single
measurement in manual mode. Subsequently, quick measurements are
carried out after each other as quickly as possible. In this connection,
the value of the systolic blood pressure is already assessed at the
beginning of the pressure outlet phase and is displayed as a flashing
number. This assessed value is overwritten by the respective following
measurement result.
The quick mode can always be exited using BPM Start/Stop. The
ongoing blood pressure measurement will then be interrupted
immediately.
It is then possible to switch to other operating modes.

 Restrictions

The list below shows examples of generally valid contra-indications:


– Using a heart/lung machine
– Complications in the peripheral circuit
– Convulsions
– Spasms
– Trembling
– Tachycardia
The decision whether to use the BPM lies within the area of
responsibility of the attending physician.

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Chapter 14: Options

14.2.10 BPM error messages

Caution
In the case of error messages and alarm situations, the first thing to
check are the patient's arm, the blood pressure cuff and the pressure
tube. When the circumstances are unclear, the pressure tube should be
disconnected from the pressure connection immediately.

Message / code Cause Possible solution

FXX BPM Error System error. The dialysis can be In case of repeated errors, contact the
(Remove the cuff from the continued without blood pressure service department.
patient! ) measurements.

BPM: Measurement value Blood pressure cuff not connected Check the blood pressure cuff
outside the alarm limits properly. Leakage in pressure tube. connection.
Alarm limits not adjusted according to Check that the pressure tube is not
patient. damaged or kinked.
Adjust alarm limits if necessary.

BPM: Cuff cannot be Blood pressure cuff not connected Check the blood pressure cuff
inflated properly. Leakage in pressure tube. connection.
Check that the pressure tube is not
damaged or kinked.

BPM: Inflation time limit Leakage in pressure tube. Check that the pressure tube is not
exceeded damaged or kinked.

BPM: Cuff pressure lower A leakage occurred during the Check the blood pressure cuff
than preselected measurement. connection.
pressure Pressure tube was kinked during the Check that the pressure tube is not
measurement. damaged or kinked.

BPM: Measuring time No valid measurement within the Start new measurement after allowing
limit exceeded allowed max. measurement time sufficient time for the blood to flow
back.

BPM: Maximum cuff Pressure tube was kinked during Check that the pressure tube is not
pressure exceeded inflation. damaged or kinked.
Cuff was squeezed after the inflation. Check the blood pressure cuff
connection.
In case of repeated errors, contact the
service department.

BPM: Inflation pressure Wrong blood pressure cuff was used. Check that the blood pressure cuff is
reached to quickly Pressure tube clogged or kinked. suitable. Wrong blood pressure cuff
was used.
Check that the pressure tube is not
obstructed, damaged or kinked.

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Chapter 14: Options

Message / code Cause Possible solution

BPM: Cuff pressure Pressure tube was kinked during Check the position of the blood
higher than preselected inflation. pressure cuff.
pressure Blood pressure cuff was squeezed after Check that the pressure tube is not
inflation. damaged or kinked.

In case of repeated errors, contact the


service department.

BPM: Measurement not It was not possible to determine a Check the position of the blood
successful measurement value. pressure cuff.

BPM: Option not Option BPM not installed. If option BPM is installed:
available Due to the error "FXX BPM error" the In case of repeated errors, contact the
BPM is no longer possible during this service department.
treatment.

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Chapter 14: Options

14.3 Transferring treatment parameters (download) (Network


option)

14.3.1 Description

The function "Transferring Treatment Parameters (Download)" makes it


possible to transfer patient-specific treatment parameters electronically
to the hemodialysis device.
The following treatment parameters can be transferred:
Patient data:
– Patient name
UF data:
– UF Rate
– UF Goal
– UF Time
– UF Profile Number
Dialysate data:
– Dialysate flow
– Dialysate temperature
– Base Na+
– Prescribed Na+
– Bicarbonate value
– Start Na+
– Na+ profile number
One can use an external system (data source) to transfer the treatment
parameters.
All the treatment parameters must be transferred to the hemodialysis
device. It is not possible to transfer individual treatment parameters.

14.3.2 Basic conditions

T1 test must have been carried out correctly.


The UF unit must be switched off.
UF volume must be set to 0000.
Prepare operating mode
(The optical detector in the air detector senses no blood, optical
detector clear fluid.)

Note
In order for the treatment parameters to be downloaded the following
conditions must be fulfilled for the transfer to occur:
– The UF unit must be switched off.
– UF volume must be set to 0000.

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Chapter 14: Options

14.3.3 Important notes

Caution
The treatment parameters received by the hemodialysis device via the
network must be checked by the user for plausibility and comply with the
physician's prescription prior to being applied.
Only after this is it possible to receive the data using the Conf key.
The data transfer of alarm states via the network must not be used as
an external alarm alert.

Caution
There are special challenges connected to the continued processing of
the data.
The user of the network is responsible for ensuring that the network is
accessible for the required data transfer.
Falsification of data related to accuracy, plausibility and completeness
caused by the network and server software is not recognized by the
hemodialysis device.

Caution
The responsible organization of the network is responsible for
protecting the device from excessive network load (e.g. by
accumulation of broadcast messages or port scans). If necessary, the
connection to the network must be established via a router or a firewall,
for example.
The system configurator is responsible for the further secure data
processing, e.g. in PC software applications.
The responsible organization of the network is responsible for the
protection of the not encrypted, transferred data.
The data transfer of alarm states via the network must not be used as
an external alarm alert.

14.3.4 Sequence

Transferring the data to the hemodialysis


device.

Download data for:

John Doe
Message
Following the correct transfer of the data, the
patient name is displayed.

Fresenius Medical Care 4008 S OP-EN 4/12.10 14-21


Chapter 14: Options

Press the Conf key.

The Ultrafiltration menu is displayed.


The background is yellow for the transferred
data.

Press the Conf key.

The Dialysate menu is displayed.


The background is yellow for the transferred
data.

Press the Conf key.

14-22 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 14: Options

John
Preparation
Doe
Display message
The patient's name is displayed on the left.
It is only displayed if all the data has
been correctly transferred.

14.3.5 Stop

Menu
e.g. Ultrafiltration menu

Press the Esc key.

Info message
Cancel Download [Conf/Esc]?
Info message
(Select with [Conf] key)

Press the Conf key.

Fresenius Medical Care 4008 S OP-EN 4/12.10 14-23


Chapter 14: Options

14-24 Fresenius Medical Care 4008 S OP-EN 4/12.10


Chapter 15: Appendix

15 Appendix

15.1 Chapter without content

To facilitate the use of documents from Fresenius Medical Care, the


organization of the chapters has been standardized in all manuals.
There may therefore be chapters within this document without any
content.

Fresenius Medical Care 4008 S OP-EN 4/12.10 15-1


Chapter 15: Appendix

15-2 Fresenius Medical Care 4008 S OP-EN 4/12.10

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