4008 S Haemodialysis Device Instructions For Use

4008 S
Haemodialysis device
Instructions for Use

Software version: 11.8
Edition: 20A-2018
Date of issue: March 2018
Part no.: F40008331
0123
Table of contents
1 Index
2 Important information
2.1 How to use the Instructions for Use ........................................................................................ 2-1
2.2 Significance of warnings .......................................................................................................... 2-2
2.3 Significance of notes ................................................................................................................ 2-2
2.4 Brief description ........................................................................................................................ 2-3
2.5 Intended use .............................................................................................................................. 2-4
2.5.1 Intended purpose......................................................................................................................... 2-4
2.5.2 Specification of the use ............................................................................................................... 2-5
2.5.3 Side effects.................................................................................................................................. 2-5
2.5.4 Contraindications......................................................................................................................... 2-5
2.5.5 Restrictions.................................................................................................................................. 2-5
2.5.6 Target group ................................................................................................................................ 2-5
2.5.7 Repair / maintenance / transport ................................................................................................. 2-6
2.5.8 Expected service life.................................................................................................................... 2-6
2.5.9 Interaction with other systems ..................................................................................................... 2-6
2.6 Duties of the responsible organisation ................................................................................... 2-7
2.7 Operator responsibility ............................................................................................................. 2-7
2.8 Disclaimer of liability................................................................................................................. 2-8
2.9 Use of consumables.................................................................................................................. 2-8
2.10 Warnings .................................................................................................................................... 2-9
2.10.1 Warnings relating to hygiene ....................................................................................................... 2-9
2.10.2 Warnings relating to the therapy................................................................................................ 2-10
2.10.3 Warnings relating to the system ................................................................................................ 2-12
2.10.4 Warnings relating to electricity................................................................................................... 2-14
2.10.5 Warnings relating to consumables / accessories / additional equipment .................................. 2-16
2.11 Addresses ................................................................................................................................ 2-17
3 Design
3.1 Views .......................................................................................................................................... 3-1
3.1.1 Front view .................................................................................................................................... 3-1
3.1.2 Rear view..................................................................................................................................... 3-2
3.1.3 Monitor front ................................................................................................................................ 3-3
3.1.4 Monitor rear and power supply unit ............................................................................................. 3-5
3.2 User interface............................................................................................................................. 3-8
3.2.1 Blood pump (arterial) ................................................................................................................... 3-8
3.2.2 Heparin pump .............................................................................................................................. 3-9
3.2.3 Level detector ............................................................................................................................ 3-10
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3.2.4 Single-Needle blood pump (option) ........................................................................................... 3-11
3.2.5 Description of the key pad ......................................................................................................... 3-12
3.2.6 Screens...................................................................................................................................... 3-13
3.2.7 Using the menus – examples .................................................................................................... 3-15
3.2.8 Menu description ....................................................................................................................... 3-17
3.2.9 Description of the messages in the menus................................................................................ 3-25
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 canister dilution 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.......................................................................................................................................... 4-8
4.1.5.1 General notes............................................................................................................... 4-8
4.1.5.2 Start.............................................................................................................................. 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 Malfunctions ............................................................................................................... 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 tubing system ............................................................................ 4-19
4.1.6.2 Setting 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 Level detector ............................................................................................................................ 4-24
4.1.8.1 Inserting the venous tubing system ............................................................................ 4-24
4.1.9 Extracorporeal blood circuit ....................................................................................................... 4-25
4.1.9.1 Priming ....................................................................................................................... 4-29
4.1.9.2 Setting the delivery rate of the blood pump ................................................................ 4-31
4.1.9.3 Delivery stops ............................................................................................................. 4-31
4.1.9.4 Interrupting the fill 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 ................................................................................. 4-34
4.1.10.4 Setting the conductivity window ................................................................................. 4-34
4.1.10.5 Sample collection ....................................................................................................... 4-35
4.1.10.6 Connecting the dialyser .............................................................................................. 4-36
4.1.10.7 Changing the dialysate flow ....................................................................................... 4-37
4.1.10.8 Changing the dialysate temperature .......................................................................... 4-38
4.1.10.9 Rinsing the dialyser .................................................................................................... 4-39
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4.2 Treatment ................................................................................................................................. 4-40
4.2.1 Ultrafiltration .............................................................................................................................. 4-40
4.2.1.1 Resetting the UF volume............................................................................................ 4-40
4.2.1.2 Entering UF parameters ............................................................................................. 4-40
4.2.1.3 Starting ultrafiltration / timer ....................................................................................... 4-43
4.2.1.4 Stopping / interrupting ultrafiltration / timer................................................................. 4-44
4.2.1.5 Continuing ultrafiltration / timer................................................................................... 4-44
4.2.1.6 Changing UF values................................................................................................... 4-44
4.2.2 Double-Needle dialysis.............................................................................................................. 4-46
4.2.2.1 Connecting the patient ............................................................................................... 4-46
4.2.2.2 Performing the dialysis ............................................................................................... 4-47
4.2.2.3 Administering a heparin bolus .................................................................................... 4-48
4.2.3 Single-Needle Click-Clack ......................................................................................................... 4-50
4.2.3.1 Selecting the treatment mode / entering treatment parameters ................................. 4-50
4.2.3.2 Changing treatment parameters / stopping treatment................................................ 4-51
4.2.4 Isolated ultrafiltration ISO-UF .................................................................................................... 4-52
4.2.4.1 Selecting the treatment mode .................................................................................... 4-52
4.2.4.2 Changing ISO UF data / stopping ISO UF ................................................................. 4-53
4.2.4.3 Manually entering the sequential ultrafiltration ........................................................... 4-54
4.2.5 Sodium and UF profiles ............................................................................................................. 4-57
4.2.5.1 General notes............................................................................................................. 4-57
4.2.5.2 Entering a UF profile without sodium profile............................................................... 4-58
4.2.5.3 Entering a UF profile with sodium profile.................................................................... 4-59
4.2.5.4 Entering a sodium profile without UF profile............................................................... 4-61
4.2.5.5 Entering a sodium profile with UF profile.................................................................... 4-62
4.2.5.6 End of program .......................................................................................................... 4-64
4.2.5.7 Stopping the program................................................................................................. 4-65
4.2.6 DIASAFE® plus ......................................................................................................................... 4-65
4.2.6.1 Display during treatment ............................................................................................ 4-65
4.3 End of treatment ...................................................................................................................... 4-66
4.3.1 Double-Needle dialysis.............................................................................................................. 4-66
4.3.2 Reinfusion.................................................................................................................................. 4-67
4.3.2.1 Procedure................................................................................................................... 4-67
4.3.2.2 Repeating the reinfusion ............................................................................................ 4-69
4.3.2.3 Skipping reinfusion ..................................................................................................... 4-70
4.3.2.4 Stop ............................................................................................................................ 4-70
4.3.3 Stopping the treatment .............................................................................................................. 4-71
4.3.3.1 Manually stopping the treatment ................................................................................ 4-71
4.3.3.2 Stopping treatment with the reinfusion program......................................................... 4-73
4.3.4 Emptying the bibag® .................................................................................................................. 4-76
4.3.5 Emptying the dialyser ................................................................................................................ 4-78
4.4 Special menu functions .......................................................................................................... 4-80
4.4.1 Changing the DIASAFE® plus ................................................................................................... 4-80
4.4.1.1 Criteria for the filter change ........................................................................................ 4-80
4.4.1.2 Indication of a filter change ........................................................................................ 4-80
4.4.1.3 Overriding a filter change ........................................................................................... 4-82
4.4.1.4 Performing a filter change .......................................................................................... 4-82
4.4.2 bibag® ........................................................................................................................................ 4-86
4.4.2.1 Emptying bibag® (during treatment)........................................................................... 4-86
4.4.2.2 Connecting the bibag® ............................................................................................... 4-88
4.4.3 Online Clearance Monitoring ..................................................................................................... 4-90
4.4.3.1 Starting Online Clearance Monitoring ........................................................................ 4-90
4.4.3.2 Manual start of Online Clearance Monitoring ............................................................. 4-90
4.4.3.3 Automatic start of Online Clearance Monitoring......................................................... 4-91
4.4.3.4 Entering or changing the OCM parameters................................................................ 4-92
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4.4.3.5 Terminating / stopping Online Clearance Monitoring ................................................. 4-93
4.4.3.6 Displaying the OCM graphics ..................................................................................... 4-94
4.4.3.7 OCM screen ............................................................................................................. 4-101
4.4.3.8 Conductivity window during a measurement ............................................................ 4-102
4.4.3.9 Changing the concentrate settings during a CD variation ........................................ 4-102
5 Alarms
5.1 Alarm limits, management ........................................................................................................ 5-2
5.1.1 Centring the arterial / venous alarm limits ................................................................................... 5-2
5.1.2 Centring the TMP alarm limits ..................................................................................................... 5-3
5.1.3 Changing the arterial / venous / TMP alarm limits ....................................................................... 5-4
5.2 Needle adjustment..................................................................................................................... 5-5
5.2.1 Start ............................................................................................................................................. 5-5
5.2.2 Stop ............................................................................................................................................. 5-6
5.3 Blood alarms .............................................................................................................................. 5-7
5.3.1 Indication of alarms...................................................................................................................... 5-7
5.3.2 Arterial pressure alarm ................................................................................................................ 5-8
5.3.3 Venous pressure alarm................................................................................................................ 5-9
5.3.4 TMP alarm ................................................................................................................................. 5-11
5.3.5 Blood dimness warning.............................................................................................................. 5-12
5.3.6 Blood leak alarm ........................................................................................................................ 5-13
5.3.7 Blood pump alarm...................................................................................................................... 5-14
5.3.8 Level detector alarm .................................................................................................................. 5-14
5.3.9 Blood pump stop alarm.............................................................................................................. 5-15
5.3.10 Blood pump stop alarm in Single-Needle mode (option) ........................................................... 5-16
5.3.11 Cycle alarm in Single-Needle Click-Clack mode ....................................................................... 5-20
5.4 Dialysate alarms ...................................................................................................................... 5-20
5.4.1 Indication of alarms.................................................................................................................... 5-20
5.4.2 Conductivity alarm ..................................................................................................................... 5-21
5.4.3 Temperature alarm .................................................................................................................... 5-21
5.4.4 Flow alarm ................................................................................................................................. 5-22
5.5 Warnings .................................................................................................................................. 5-23
5.5.1 Indication of warnings ................................................................................................................ 5-23
5.5.2 Heparin pump warnings............................................................................................................. 5-23
5.5.3 Warning / information messages ............................................................................................... 5-25
5.6 Power failure ............................................................................................................................ 5-29
5.6.1 Power failure and battery operation........................................................................................... 5-29
5.6.2 Power failure and depleted rechargeable battery ...................................................................... 5-31
5.7 Error messages during cleaning programs .......................................................................... 5-32
5.7.1 Indication of errors ..................................................................................................................... 5-32
5.7.2 Error messages ......................................................................................................................... 5-33
5.8 Error messages after turning power on ................................................................................ 5-37
5.9 Messages during treatment parameter transfer (option)..................................................... 5-37
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6 Cleaning / disinfection
6.1 General overview....................................................................................................................... 6-2
6.1.1 General notes .............................................................................................................................. 6-3
6.2 Surface cleaning........................................................................................................................ 6-3
6.3 Basic conditions for cleaning programs................................................................................. 6-3
6.4 Disinfection, decalcification ..................................................................................................... 6-4
6.4.1 Starting ........................................................................................................................................ 6-4
6.4.2 Sequence .................................................................................................................................... 6-5
6.4.3 Stopping the program .................................................................................................................. 6-6
6.5 Cleaning / degreasing program................................................................................................ 6-7
6.5.1 Starting ........................................................................................................................................ 6-8
6.5.2 Sequence .................................................................................................................................. 6-10
6.5.3 Stopping the program ................................................................................................................ 6-11
6.6 Hot rinse ................................................................................................................................... 6-11
6.6.1 Starting ...................................................................................................................................... 6-11
6.6.2 Sequence .................................................................................................................................. 6-12
6.7 Rinse......................................................................................................................................... 6-14
6.7.1 Starting ...................................................................................................................................... 6-14
6.7.2 Sequence .................................................................................................................................. 6-14
6.8 Priming during cleaning programs........................................................................................ 6-16
6.8.1 Basic conditions......................................................................................................................... 6-16
6.8.2 Start ........................................................................................................................................... 6-17
6.8.3 Setting the delivery rate of the blood pump ............................................................................... 6-18
6.8.4 Delivery stops ............................................................................................................................ 6-18
6.8.5 Interrupting the fill program........................................................................................................ 6-19
6.8.6 Premature termination ............................................................................................................... 6-19
6.8.7 Malfunctions .............................................................................................................................. 6-20
6.9 Precirculation during the cleaning programs....................................................................... 6-20
6.9.1 Basic conditions......................................................................................................................... 6-20
6.9.2 Preselection............................................................................................................................... 6-21
6.9.3 Starting ...................................................................................................................................... 6-21
6.9.4 Setting the delivery rate of the blood pump ............................................................................... 6-22
6.9.5 Delivery stops ............................................................................................................................ 6-23
6.9.6 Interrupting precirculation .......................................................................................................... 6-23
6.9.7 Premature termination ............................................................................................................... 6-24
7 Functional description
7.1 Description of the procedure ................................................................................................... 7-1
7.1.1 Hydraulic flow diagram 4008 S.................................................................................................... 7-1
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 measuring procedure ........................................................................................ 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
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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 cumulated blood volume..................................................................... 7-29
7.3 Cleaning programs .................................................................................................................. 7-29
7.3.1 General information on the cleaning programs.......................................................................... 7-29
7.3.2 Disinfection, decalcification........................................................................................................ 7-30
8 Consumables, accessories, additional equipment

8.1 Single use item .......................................................................................................................... 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 dialysis device .................................................................................................... 9-5
9.1.2 Inserting / priming the DIASAFE® plus ........................................................................................ 9-9
10 Transport / storage
10.1 Relocation ................................................................................................................................ 10-1
10.2 Transport .................................................................................................................................. 10-3
10.3 Storage ..................................................................................................................................... 10-4
10.3.1 Storage conditions ..................................................................................................................... 10-4
10.4 Environmental impact and recycling ..................................................................................... 10-5
10.4.1 Material list................................................................................................................................. 10-5
11 Technical Safety Checks / Maintenance

11.1 Important information for performing TSCs ......................................................................... 11-1
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12 Specifications
12.1 Dimensions and weight .......................................................................................................... 12-1
12.2 Electrical safety ....................................................................................................................... 12-1
12.3 Information on electromagnetic compatibility
(IEC 60601-1-2:2014)................................................................................................................ 12-1
12.3.1 Minimum distances between radiation source and medical electrical equipment ..................... 12-2
12.3.2 Guidance and manufacturer's declaration on EMC ................................................................... 12-3
12.4 Electrical supply ...................................................................................................................... 12-4
12.5 Identification label (device identification) ............................................................................. 12-5
12.6 Fuses ........................................................................................................................................ 12-6
12.7 Operating conditions .............................................................................................................. 12-6
12.8 Consumption data / energy data............................................................................................ 12-7
12.9 External connection options .................................................................................................. 12-7
12.10 Override conditions................................................................................................................. 12-9
12.11 Operating programs ................................................................................................................ 12-9
12.12 Dialysate circuit and safety systems................................................................................... 12-10
12.13 Extracorporeal blood circuit and safety systems .............................................................. 12-13
13 Definitions
13.1 Definitions and terms.............................................................................................................. 13-1
13.2 Abbreviations........................................................................................................................... 13-2
13.3 Symbols.................................................................................................................................... 13-3
13.4 Symbols for consumables (extract)....................................................................................... 13-6
13.5 Bibliography............................................................................................................................. 13-7
13.6 Certificates ............................................................................................................................... 13-9
13.6.1 EC certificate ............................................................................................................................. 13-9
14 Options
14.1 Single-Needle dialysis............................................................................................................. 14-1
14.1.1 Preparation ................................................................................................................................ 14-1
14.1.1.1 Setting the stroke volume when using a Single-Needle blood pump ......................... 14-2
14.1.1.2 Connecting the patient ............................................................................................... 14-2
14.1.1.3 End of treatment......................................................................................................... 14-5
14.2 Option BPM (Blood Pressure Monitoring) ............................................................................ 14-7
14.2.1 To be observed before using the BPM option ........................................................................... 14-7
14.2.2 BPM menu overview.................................................................................................................. 14-9
14.2.3 Alarm reactions for physiological alarms (SYS, DIA, MAP, and pulse) ................................... 14-10
14.2.4 Applying the blood pressure cuff ............................................................................................. 14-11
14.2.5 Checking / setting the inflation pressure / alarm limits ............................................................ 14-12
14.2.6 Starting the blood pressure measurement .............................................................................. 14-12
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14.2.6.1 Single measurement ................................................................................................ 14-13
14.2.6.2 Interval (long interval measurement) ........................................................................ 14-13
14.2.6.3 Quick (short interval measurement) ......................................................................... 14-15
14.2.7 Terminating / stopping the blood pressure measurement ....................................................... 14-15
14.2.8 Displaying graphics and blood pressure history ...................................................................... 14-16
14.2.9 Specifications / general notes................................................................................................. 14-17
14.2.10 Description of the BPM ............................................................................................................ 14-19
14.2.11 BPM error messages .............................................................................................................. 14-20
14.3 Data transfer of treatment parameters
(download and upload) (option) ........................................................................................... 14-22
14.3.1 Important notes........................................................................................................................ 14-22
14.3.2 Description............................................................................................................................... 14-22
14.3.3 Status indicators for treatment parameter transfer .................................................................. 14-23
14.3.4 Insert the PatientCard (patient card)........................................................................................ 14-25
14.3.5 Download – conditions............................................................................................................. 14-26
14.3.6 Download – sequence ............................................................................................................. 14-26
14.3.7 Download – stop ...................................................................................................................... 14-28
14.3.8 Upload – conditions ................................................................................................................. 14-29
14.3.9 Upload – sequence.................................................................................................................. 14-29
14.3.10 Upload – stop........................................................................................................................... 14-29
15 Appendix
(IEC 60601-1-2:2007)................................................................................................................ 15-1
15.1.1 Minimum distances between radiation source and device ........................................................ 15-1
15.1.2 Guidance and manufacturer's declaration on EMC ................................................................... 15-3
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Chapter 1: Index
1 Index
A Blood pump stop alarm in Single- Disinfection, decalcification 6-4
Needle mode (option) 5-16 Download 14-26
Abbreviations 13-2
BPM 14-7, 14-19 Drain 3-2
Acetate dialysis 4-5
BPM pressure connection 14-18
Acute alarm system 3-5, 3-21
BPM restrictions 14-7 E
AdaptedFlow 4-37, 4-38, 4-67,
Brake 3-1
4-72 Electrical safety 12-1
Bubble catcher 4-24, 4-31, 4-47
Addresses 2-17 Electrical unit 9-1
Alarm in (alarm input) 12-8 Electromagnetic compatibility
Alarm output (external alarm) 12-8 C (IEC60601-1-2
Alarm processing 5-1 Central Delivery System 2-13, 3-2, 2014) 12-1
Alarm, audible alarm 12-15 4-3, 7-5, 9-3 Electromagnetic emissions 12-3,
Appendix 14-1, 15-1 Cleaning / degreasing program 6-7 15-3
Cleaning / disinfection 6-1 Electromagnetic immunity 12-3,
Arterial pressure 13-1
Cleaning programs, basic 15-3
Arterial pressure alarm 5-8
conditions 6-3 Emptying the dialyser 4-78
Arterial tubing system, inserting
Connect the Single-Needle Environmental impact and
4-19
pressure transducer. 14-1 recycling 10-5
Aseptic technique 2-9, 2-10, 4-26
Consumables / accessories / Error messages during cleaning
Audio paused 12-9 programs 5-32
additional equipment 8-1
Consumables, use 2-8 External connection options 12-7
B Contraindications 2-5 Extracorporeal blood circuit
bibag® 4-6 module 3-1
bibag®, emptying 4-76 D
Bicarbonate dialysis 4-6
Decalcification, agents 8-5
F
Bicarbonate dialysis with bibag® Fields of application 2-4
Definitions and terms 13-1
4-7 Filter life time, DIASAFE® plus
Degreasing program 6-7
Blood alarms 5-7, 13-1 12-13
Design 3-1
Blood dimness warning 5-12 Functional checks prior to each
Dialysate flow, changing 4-37
Blood leak alarm 5-13 dialysis treatment 4-32
Dialysate inlet tube 3-2
Blood pressure 14-18 Functional description 7-1
Dialysate outlet tube 3-2
Blood pressure cuff 3-1, 14-18
Dialysate temperature, changing
Blood pressure cuff holder 14-18
4-38
G
Blood pressure cuff, applying Guidance and manufacturer's
Dialyser, connecting 4-36
14-11 declaration on EMC 12-3
Dialysers 8-2
Blood pressure cuffs 8-8
Dialysis dose Kt/V 7-15
Blood pressure measurement H
14-7 DIASAFE® plus, filter life time
12-13 Heparin pump 3-9, 4-21
Blood pressure measurement,
start 14-12 Dilution 4-3 Heparin pump, positioning the
Dimensions 12-1 slide carriage 4-21
Blood pressure measurement,
terminating 14-15 Disinfectant connector 3-2 Heparin pump, setting the delivery
Disinfectants 8-3 rate 4-22
Blood pump (arterial) 3-8
Heparin pump, setting the stop
Blood pump alarm 5-14 Disinfection 6-1, 8-4
time 4-23
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Chapter 1: Index
Heparin pump, stop time 7-25 O Service life, expected 2-6

Heparin pump, turning stop time Side effects 2-5
Operating conditions /
off 4-24 Single measurement (blood
specifications 12-6
Hot rinse 6-11 Operation 4-1 pressure) 14-13
Operation status indicator (traffic Single measurement, BPM 14-19

I light) 3-4 Single-Needle blood pump
Operator responsibility 2-7 (option) 3-11
Important information 2-1
Overriding the alarm 12-9 Slide carriage, positioning 4-21
Indicator for disinfectants 8-6
Specification of the use 2-5
Inflation pressure 14-12
Standard alarm system 3-5, 3-21
Initial start-up, important P
information 9-1 Stop time of heparin pump 7-25
PatientCard (patient card) 14-25
Installation 9-1 Storage 10-4
Power failure 5-29
Instructions for Use, how to use Storage conditions 10-4
Power supply unit 3-2
2-1 Surface cleaning 6-3
Precirculation during the cleaning
Intended purpose 2-4 Symbols 13-3
programs 6-20
Intended use 2-4
Pressure tubing 14-18
Interaction with other systems 2-6
Pressure tubing, BPM 8-8 T
Interval (long interval Target group 2-5
Priming during cleaning programs
measurement) 14-13 6-16 Technical Safety Checks /
Interval (long-term interval Maintenance 11-1
Pulse 14-18
measurement), BPM 14-19
Temperature alarm 5-21
Interval mode, deactivating (blood
Q Transferring treatment parameters
pressure) 14-14
(option) 14-22
Quick (short-term interval
Transport / storage 10-1
K measurement) 14-15
Treatment 4-40
Quick (short-term interval
Key pad 3-12 Treatment, items to be observed
measurement), BPM 14-19
Kt/V 7-15 before and during treatment 4-25
R
L U
Rechargeable battery 12-5
Level detector 3-10 UF volume, resetting 4-40
Recommissioning 11-1
Level detector alarm 5-14 Ultrafiltration 4-40
Removal from service, temporary
Liability, disclaimer 2-8 12-6 Upload 14-29
Repair / maintenance / transport User interface 3-8
M 2-6
Manufacturer 2-17
Residual disinfectant, checking V
6-5
Menus, using 3-15 Venous occlusion clamp 3-10,
Responsible organisation, duties 4-25
Minimum distances between 2-7
radiation source and device 12-2, Venous pressure measurement
Rinse 6-14 line 4-25
15-1
Risk of tilting 2-12, 10-1, 13-3 Venous tubing system, inserting
Monitor front 3-3
4-24
N S Vent tubing 3-2

Sample collection 4-35
Notes, significance 2-2
Sampling valve 3-2
Screen colours 3-14
Screens 3-13
1-2 Fresenius Medical Care 4008 S IFU-EN-UK 20A-2018

Chapter 1: Index
W
Warnings, significance 2-2
Water supply (permeate) 3-2
Weight 12-1

Chapter 1: Index

Chapter 2: Important information
2 Important information
2.1 How to use the Instructions for Use
Identification The document can be identified by the following information on the title
page and on the labels, if any:
– Device software version
– Edition of the document
– Document date of issue
– Part number of the document
Footer The footer contains the following information:

– Company name
– Device type
– The English abbreviation for the document type and the international
abbreviation for the document language, e.g. IFU-EN refers to
Instructions for Use in English.
– Editorial information, e.g. 4A-2011 refers to edition 4A from 2011
– Page identification, e.g. 1-3 refers to chapter 1, page 3
Organisation of the To facilitate the use of documents from Fresenius Medical Care, the
chapters organisation of the chapters has been standardised in all manuals.
There may therefore be chapters within this document without any
content. Chapters without content are marked accordingly.
Representation in the The following types of representation can be used in the document:
document
Representation Description
Keys Keys on the device are shown in bold type.

Example: UF Menu key.
Status indicators Status indicators on the device are shown in

(LED) bold type.
Example: Operation (green) status
indicator.
Menu names and Menu names and fields are shown in bold
fields on the screen type on the screen.
Example: Delete treatment parameters
field
Illustrations The illustrations used in the documents may differ from the original if
this does not affect 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 Instructions for Use are part of the accompanying documents and
instructions are an essential part of the device. They contain information necessary
for operating the device.
The Instructions for Use must be carefully studied before attempting to
operate the device.
Before the responsible organisation can begin operating 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 Instructions for Use.
The device may only be operated by individuals who have been
verifiably instructed in the proper operation and handling of the device.
Changes Changes to documents will be released as new editions or

supplements. In general: this document is subject to change without
notice.
Reproduction Reproduction, even in part, is only permitted with written approval.
2.2 Significance of warnings
Warning
Advises the operator that failure to observe this information can result
in personal injury.
2.3 Significance of notes
Note
Advises the operator that failure to observe this information can have
the following results:
– damage to the device
– desired functions will not be executed at all or will be executed
incorrectly

2.4 Brief description
The 4008 S haemodialysis 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 LCD
screen. The current treatment parameters are shown on the screen.
In the dialysate circuit, pure water is mixed with haemodialysis
concentrate, heated, degassed and delivered to the dialyser. Inflowing
and outflowing volumes are balanced volumetrically. The pressure at
the dialyser is adjusted depending on the ultrafiltration rate selected and
the type of dialyser used.
With the DIASAFE® plus function, haemodialysis treatments can be
performed with high purity dialysate. 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 haemodialysis 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 haemodialysis 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. If the option is used, the
process water and dialysate quality must meet the appropriate
standards (see Chapter 9 on page 9-1).
In the extracorporeal blood circuit, the blood is continuously heparinised
and passed through the dialyser. A level 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 an aspiration of the needle in the vessel.
The haemodialysis device is designed for both acetate dialysis and
bicarbonate dialysis.
The dilution of concentrate to pure water can be programmed (default
setting 1+34, selection of other dilution 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.
If the AdaptedFlow function is activated, a reduced dialysate flow of
300 ml/min will be set automatically in the operating modes
"Preparation" and "Reinfusion".

The dialysate flow can be set in the SETUP to 300 ml/min, 500 ml/min,
800 ml/min or AdaptedFlow.
The AdaptedFlow adapts the dialysate flow to the effective blood flow
using a preset factor. Default value: 1.2. In the SETUP, the factor can
be set to 1.2 or 1.5 times the effective blood flow. A variable factor
between 1.0 and 2.0 can also be preset in increments of 0.1.
The basic version of the haemodialysis device is designed for
Double-Needle dialysis.
Freely selectable programs are available for cleaning and disinfecting
the device.
The haemodialysis device is equipped with all safety systems required
for proper function and patient safety (EN 60601-1).
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 haemodialysis device will request the
operator to perform the T1 test:
– after power on (not following a power failure).
– following 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 haemodialysis device 4008S is manufactured according to the
state of the art and complies with the requirements of EN 60601-1.
It is classified as Class II b (MDD) equipment.
2.5 Intended use
2.5.1 Intended purpose
The device is used for the extracorporeal blood treatment of patients

suffering from renal insufficiency.
Consumables with a service life adapted to the duration of therapy have
to be used for the treatment; see specification in the operator
documentation of the consumables.

2.5.2 Specification of the use
The device has been specified by the manufacturer for the following
purposes:
– Treatment of patients with a body weight of 40 kg or more. For this
purpose, the safety systems and protective devices are designed for
possible fault conditions and defects. The attending physician bears
the responsibility for treating patients with a lower body weight. In
this case, the attending physician has to observe the deviation
tolerance, which will cause the safety system to react if the deviation
from the specified therapeutic value is too significant.
– Subsequently programmed treatments with a duration of less than
10 hours, limited by the programmability of the UF timer.
Subsequent treatments of one patient are possible.
– Operation in rooms suitable for dialysis treatments, inside
professional health care facilities or for medical care at home.
2.5.3 Side effects
Haemodialysis therapies occasionally cause hypotension, nausea,

vomiting and cramps in some patients. Please read the package inserts
enclosed with the haemodialysis concentrates and dialysers, etc. To
reduce possible side effects of the treatment, the therapy specification
should be customised for the patient.
2.5.4 Contraindications
– Hyperkalemia (for potassium-containing haemodialysis

concentrates only)
– Hypokalemia (for potassium-free haemodialysis concentrates only)
– Uncontrollable coagulation anomalies
A different method of extracorporeal treatment may be indicated in
haemodynamically unstable patients.
2.5.5 Restrictions
None
2.5.6 Target group
Warning
The device may only be installed, operated and used by individuals with
the appropriate training, knowledge and experience and who have been
verifiably instructed.

2.5.7 Repair / maintenance / transport
Warning
Start-up, extensions, adjustments, calibrations, maintenance
procedures, modifications or repairs may only be carried out by the
manufacturer or persons authorised by them.
Technical Safety Checks, maintenance points and further explanations

on how to perform them can be found in the Service Manual (see
Chapter 11 on page 11-1).
The service switch for service mode may only be operated by an
authorised technician or by a person authorised by the responsible
organisation (see Chapter 3.1.4 on page 3-5).
Use only original spare parts.
For identification and for ordering spare parts, test equipment and tools,
always use the electronic spare parts catalogue.
Transport and storage (see Chapter 10 on page 10-1)
2.5.8 Expected service life
If the TSC are performed to the extent prescribed and within the time
intervals specified, safe operation will be ensured in the intervening
time.
In addition, the manufacturer recommends that maintenance is carried
out within the same time interval to avoid device malfunction due to
wear and tear.
The "expected service life" as defined by IEC 60601-1 is thus extended
by each TSC to the next specified TSC.
2.5.9 Interaction with other systems
Due to friction at the pump segment, very low electrostatic discharges

into the tubing system may occur during operation of a line roller pump.
Because of their low charge strength, these discharges do not
represent a direct risk to patients or operators. If ECG devices are used
at the same time, these discharges may, in rare cases, cause periodic
interference of the ECG signal. In order to minimise this interference, it
is important to note the ECG device manufacturer's recommendations,
e.g.:
– correct position of the electrodes
– use of specific electrodes with low contact impedance

2.6 Duties of the responsible organisation
The responsible organisation must ensure:

– compliance with the national or local installation, operation, use and
maintenance regulations
– compliance with accident prevention regulations
– that the device is safe and in good condition
– that the Instructions for Use are always accessible
To enhance treatment quality and patient safety, the manufacturer
recommends following the guideline IEC / TR 62653 "Guideline for safe
operation of medical devices used for haemodialysis treatment". The
guideline describes the requirements for using haemodialysis devices
safely and for their intended purpose.
2.7 Operator responsibility
The addresses given herein must be used to notify the manufacturer of any unexpected operation or other incidents
(see Chapter 2.11 on page 2-17).
Warning
The device must not be put into operation in the event of mechanical
damage, a defective power cable, other defects, a deterioration of the
performance characteristics or if does not react as expected.
An ongoing treatment must be stopped. The device must be taken out
of service.
Inform the responsible organisation or the technical service support.
Damaged parts must be replaced.
The following must be observed when entering parameters (especially

UF parameters):
The parameters entered must be verified by the operator, i.e. the
operator must check that the values entered are correct. If the
verification reveals a deviation between the desired parameters and the
parameters displayed on the device, the setting must be corrected
before activating the function.
The actual values displayed must be compared with the desired values
specified.
The device may only be operated under the operating conditions
indicated by the manufacturer.

2.8 Disclaimer of liability
Warning
The device has been approved for use with certain consumables and
accessories (see Chapter 8 on page 8-1).
Should the responsible organisation wish to use consumables and
accessories other than those listed here, it must verify their suitability
beforehand, e.g. by obtaining information from the respective
manufacturer. The applicable legal regulations must be complied with.
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.
2.9 Use of consumables
Please note the symbols printed on the packaging of the consumables

When using consumables, it is particularly important to take note of the
following symbols (see Chapter 13.4 on page 13-6):
Do not re-use
2
Use by date
The consumables may only be used if the packaging and the respective
consumables, 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
certain components of drugs or disinfectants. If they are to be used, it is
important to ensure prior to starting treatment that the consumables'
components are compatible. If, for example, connectors made of
polycarbonate are exposed to aqueous solutions with a pH value > 10
or to aliphatic solutions, this will cause tension cracks.

2.10 Warnings
The following list of warnings represent an extract only. Knowledge of

all warnings mentioned in these Instructions for Use is required for the
safe operation of the haemodialysis device.
2.10.1 Warnings relating to hygiene
Warning
Aseptic technique:
Use aseptic technique for all blood-side connections and all
connections in the area where sterile solutions are to be used.
Warning
It is imperative that the device is disinfected after each dialysis
treatment.
Warning
If the device has been idle for more than 72 hours, a disinfection
program should be performed before initiating the next treatment.

2.10.2 Warnings relating to the therapy
Warning
Preventing contamination:
To prevent cross-contamination, only use tubing systems with
hydrophobic filters on the pressure lines.
The hydrophobic filters must be connected in such a way that there is
no ingress or loss of air, and there is no chance of the filters becoming
wet even in the event of pressure fluctuations.
If a hydrophobic filter has become wet, the tubing system must be
replaced.
On tubing systems 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 using a syringe.
This could damage the hydrophobic membrane and therefore lead to
contamination.
In case fluid may have passed through the hydrophobic filter, the device
must be checked for contamination after the treatment has been
completed. If the device is contaminated, it has to be taken out of
service. All affected parts must be disinfected or replaced according to
the manufacturer's specifications before recommissioning the device.
Warning
Before treatment, check:
– The safe connection of all connection sites of the tubing system.
– The tightness of the tubing system during and after priming.
– If necessary, re-tighten the connections and replace the tubing
system.
– Check the protective caps are tight and tighten them if necessary.
– The lines for the supply of infusions should always be clamped,
except if they are needed.
– The absence of air in the tubing system as well as absence of kinks,
tensions and twists and the correct position of all fluid levels. The
lines must not be squeezed (risk of haemolysis during the
treatment). Always use the tube holders provided.
Warning
To be observed when working on the tubing system during
treatment:
If the position of the tubing system or of one of its components is
changed, the correct position of the entire tubing system must be
restored afterwards, particularly the correct position of the tube guides.

Warning
During treatment, check at regular intervals:
– The condition of the patient.
– The function of the device and of the extracorporeal blood circuit.
To protect the patient from a dangerous loss of blood into the
surrounding area, venous pressure monitoring is used as a safety
system for the extracorporeal blood circuit.
Pressure monitoring, however, cannot detect a loss of blood into the
surrounding area in every situation. This is particularly critical when
there is a venous needle dislocation or a small leak in the positive
pressure section of the extracorporeal blood circuit.
For this reason, the extracorporeal blood circuit must be checked at
regular intervals for leakages, especially the tubing system
connections and the venous access site.
– The tubing system for entry of air or possible loosening of the
connections. Particularly at connection points after the level
detector, negative pressure can permit air to enter the
extracorporeal blood circuit. This can be the case, for example,
when using Single-Needle Dialysis or central venous catheters.
– The fluid level in the venous bubble catcher. Correct the fluid level,
if required.
– The tubing system for absence of kinks, tensions and twists (risk of
haemolysis).
– All unused access and drain sites must be closed with the clamps
provided.
Warning
Venous alarm limit
It is important to set the lower venous alarm limit as close as possible to
the actual venous pressure value.
Warning
The treatment parameters cannot 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.
Warning
Risk of injury due to damaged tubing system
Risk of infection
The tubing system must be laid in such a manner that it cannot be
damaged by sharp-edged objects or by pets.

2.10.3 Warnings relating to the system
Warning
– Risk of caustic burning
Warning; Corrosive substance
– Risk of scalding
Warning; Hot surface; Hot fluids or vapours
Before transporting the device, ensure that there are no caustic or hot
liquids in the device. Programs such as disinfection or hot rinse
(incl. cooling rinse) have to be completed.
Warning
Risk of tilting when pushing the device or leaning against it
Lateral force exerted on the device may result in the device tilting or
slipping. Please observe the specified transport conditions.

Warning
– Hot rinse – risk of burns and scalding

– Hot disinfection – risk of burns, scalding and caustic burning
– Disinfection – caustic burning
These risks arise at the following parts of the device which can be
touched, opened and detached:
– Concentrate and bicarbonate flap
– Concentrate and bicarbonate suction tubes
– Shunt cover
– Dialysate tubes and dialysate connectors
– DIASAFE® plus
– Water drain
– Vent (rear of device)
During hot disinfection / hot rinse, hot water or steam can escape
through the overflow
These risks can be present until the respective cleaning program has
finished and the device has cooled down.
Warning
When using an RO unit or CDS, please note the following:
Instructions for Use of the RO unit or CDS used.
When cleaning the RO unit and its supply lines, the haemodialysis
device must be disconnected from the RO unit at the water supply.
During cleaning of the CDS supply lines, the haemodialysis device must
be disconnected from the CDS.
To ensure that the water quality is always as good as possible, regular
checks and, if necessary, disinfection / cleaning cycles of the water
supply system must be carried out. This also applies to the water supply
tubing connected to the haemodialysis device.
In addition, please note the information provided under "External
connection options" (see Chapter 12.9 on page 12-7).

Warning
Risk of injury due to ingestion of small parts.
Danger of suffocation from small parts.
Store small loose parts away from children.
Warning
Danger of suffocation by strangulation.
Lay the cables and tubing in such a manner that they do not represent
a danger to children.
Warning
Stab wounds
Infection, cross infection
Keep new or used cannulas in a safe place.
2.10.4 Warnings relating to electricity
Warning
The "type of protection against electric shock" for this device is
"Protection class I". To avoid the risk of electric shock, this device
should only be connected to a power supply network with a protective
earth.
It must be taken into consideration that in many countries, regulations
have been specified by the national authorities.
Warning
Do not use multi-way sockets or extension cables.

Warning
When using central venous catheters, the following precautions must
be observed:
1. The dialysis device must be connected to the equipotential bonding.
2. If there are other electromedical devices on the patient or in their
tangible environment, it must be ensured that all leakage currents
from these devices (device leakage currents, housing leakage
currents, earth leakage currents and patient leakage currents) are
below the respective alarm limit for CF applied parts.
This means:
maximum 10 µA in normal conditions and 50 µA in the event of a
"first fault".
This also applies to patient positioning devices (e.g. patient
couches).
Devices which comply with these leakage current limits but use an
application current which is larger than the specified leakage current
values (e.g. stimulation current equipment) must not be used. This
also applies to defibrillators which do not have a floating type CF
applied part.
If all the conditions are fulfilled, such devices can be operated on the
patient or in their tangible environment if they are integrated into the
equipotential bonding like the dialysis device.
If these conditions are not fulfilled, no other electromedical devices
may be located on the patient or in their tangible environment.
If in doubt, consult the respective technician.
Leakage currents from an additional

electromedical device can flow to earth
via the central venous catheter.
Catheter
Dialysis device Additional

electromedical device
All types! (B / BF / CF)
Housing leakage
currents
of all types are 10 times
The patient is higher than "CF"
electrically patient leakage current!
connected to the
earth potential via
their blood and the
dialysate.

3. A room from Group 1 is sufficient for the room version. This means
that the mains can be switched off in the event of a first fault, and the
treatment can be stopped or repeated.
Furthermore, the room must be equipped with an equipotential
bonding. For further information, refer to the national standards and
regulations (e.g. DIN VDE 0100-710 in Germany).
Warning
The operator should not simultaneously touch the patient and the
contacts of the jacks or connectors (e.g. Ethernet jack or the contacts of
the Ethernet data cable).
Warning
Risk of injury caused by electric current.
Electric shock
The connecting cable must be laid in such a manner that it cannot be
damaged by sharp-edged objects or by pets.
2.10.5 Warnings relating to consumables / accessories / additional equipment
Warning
Warning
Observe the following information regarding disinfectants:
– the printed expiry date
– the storage conditions for the disinfectant concentrates
– the manufacturer’s instructions for use
Warning
After the treatment, consumables must be disposed of according to the
regulations for handling potentially contaminated materials.

2.11 Addresses
Manufacturer Fresenius Medical Care AG & Co. KGaA

61346 Bad Homburg
Germany
Telephone: +49 6172 609-0
www.fmc-ag.com
International service Fresenius Medical Care

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


Chapter 3: Design
3 Design
3.1 Views
3.1.1 Front view
1 Monitor
2 Blood pressure cuff
3 Card reader for the PatientCard (option)
4 Extracorporeal blood circuit module
5 Concentrate connectors
9 6 Brake
1
7 Shunt interlock for the dialyser
connecting tubes
8
2 8 IV pole
9 Operation status indicator (traffic light)
3
7

Chapter 3: Design
3.1.2 Rear view
1 Monitor (rear view)

2 Sampling valve
3 Bracket for the dialyser connection
tubes
4 Dialysate outlet tube
5 Dialysate inlet tube
1 6 Disinfectant connector
7 Filter
8 CDS (red) option
9 Drain
10 Water supply (permeate) or connector
for water inlet filter
11 DIASAFE® plus
13
12 Vent tubing
13 Power supply unit
2
3
12
11
5
6 10
7 9

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 status indicator
2a Cleaning key
2b Cleaning status indicator
3a SN key
3b SN status indicator
4a Test key
4b Test status indicator
5a Prime key
5b Prime status indicator
6a Start/Reset key
6b Start/Reset status indicator
7a Audio paused key

Chapter 3: Design
7b Audio paused status indicator
Blood monitor (pos. 8–12) 8a Air Detector status indicator

9a Blood Leak status indicator
10a Arterial Pressure status indicator
10b Arterial Pressure measurement value indicator
11a Venous Pressure status indicator
11b Venous Pressure measurement value indicator
12a TMP status indicator
12b TMP measurement value indicator
Dialysate monitor 13a Conductivity status indicator

(pos. 13–15)
13b Conductivity measurement value indicator
14a Flow status indicator
Status indicator is illuminated: the flow is on
Status indicator not illuminated: the flow is off
Status indicator is flashing: bypass is active
14b Flow ON/OFF key
15a Dialysate menu key
Ultrafiltration section 16a UF status indicator

(pos. 16)
16b UF ON/OFF status indicator
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
 Description of the operation status indicator (traffic light)
Visual alarm signal

Chapter 3: Design
Possible conditions:
– Operation status indicator shows green light (operation)
– Operation status indicator shows yellow light (warning / info).
– Standard alarm system:
Operation status indicator with a stable red light (alarm).
– Acute alarm system:
Operation status indicator flashes red (alarm).
3.1.4 Monitor rear and power supply unit
Warning
Other, additional equipment connected to this device must comply with

the valid IEC or ISO standards (e.g. IEC 60950-1 for information
technology equipment).
Furthermore, all device configurations must comply with the normative
requirements for medical electrical systems (see Chapter 16 and
Appendix I to EN 60601-1:2006).
1 2 3 4 5 6 7
16 8
15 9
14 10
13
12
11
1 Service switch
organisation.
2 Audible alarm volume control

Chapter 3: Design
Warning
Risk to the patient due to alarm signals being ignored
The audible alarm will not be heard if its volume is lower than the
volume of the surrounding environment.
 Use the volume control to set the audible alarm volume higher than
the volume of the surrounding environment.
3 Not used
(do not connect anything to this port!)
4 Port for service measuring devices
(service measuring devices may not be used during treatment).
5 Connection jack PC
(for the connection of a service PC only (may not be used during
treatment)).
6 ALARM IN port
(used to connect an external Fresenius patient button or an
AquaUNO / AquaC UNO H. These devices can be used to trigger
a device to stop).
7 ALARM OUT port
(can be used to connect an external alarm indicator, staff call).
8 Hour meter
9 Loudspeaker for audible alarm
10 Remote control port (option)
11 Power cable with locking screw
(This cable supplies the haemodialysis system with mains
voltage.)
12 Power switch (main switch)
13 Power supply unit (voltage supply for the haemodialysis device)
14 Not used
15 LAN (Local Area Network) network connection (option)
Connecting the device to an IT network that contains components
not installed and validated by the manufacturer can introduce
unknown risks for patients, operators or third parties. These risks
must be identified, analysed, evaluated and checked by the
responsible organisation. For assistance, consult
IEC 80001-1:2010 and annexes H5 and H6 to EN 60601-1:2006.
Any modification to an IT network that has been installed and
validated by the device manufacturer can introduce new risks and
therefore requires a repeat analysis. Especially problematic
activities:
– changes to the IT network configuration
– connection of additional components and devices to the IT
network
– removal of components and devices from the IT network
– updating or upgrading components and devices in the IT
network

Chapter 3: Design
Attention is drawn to the fact that local laws take priority over the
above-mentioned normative requirements. If in doubt, consult the
local service support.
The responsible organisation has to ensure that the device is
protected 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 configurer is responsible for secure further processing
of data, e.g. in PC software applications.
The network operator is responsible for protecting data which is
transferred unencrypted.
The data transfer of alarm states via the network must not be used
for the purpose of external alerts.
16 Fan

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, or an error
code)
3 Status indicator (red)
4 Operation (green) status indicator
5 Start/Stop key (for turning the blood pump on or off)
6 Pressure connector (Luer-Lock connector of the arterial pressure
measurement line), highlighted in red
7 Rotor (delivers the patient’s blood by means of the rollers and the
tubing system. The rotor can be removed for cleaning.)
8 Clamping section (holds the installed tube 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)

Chapter 3: Design
3.2.2 Heparin pump
12
2
3 11
4 10
5 9
8
1 Display (displays the delivery rate, the stop time, the bolus amount
or an error code)
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 forward)
9 Clock key (for setting the stop time)
10 Stop time (green) status indicator
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 backwards)

Chapter 3: Design
3.2.3 Level 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 measurement line)
3 Holder for the venous bubble catcher with ultrasonic sensors
4 Venous occlusion clamp
5 Optical detector

Chapter 3: Design
3.2.4 Single-Needle blood pump (option)
1 2 3
12 4
11 5
8
9
10

2 Display (indicates the delivery rate, the tube 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 tube diameter)
5  key (for reducing the delivery rate, the SN stroke volume or the
value of the tube diameter)
6 Pressure connector (Luer-Lock connector of the SN pressure
measurement line), highlighted in white
7 Rotor (delivers the patient’s blood by means of the rollers and the
tubing system. The rotor can be removed for cleaning.)
8 Blood pump door
9 Sensor (blood pump door open or closed)
10 Clamping section (holds the installed tube segment securely in
place)
11 Start/Stop key (for turning the blood pump on or off)

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 the necessary data in the menu has been changed, the
changes are saved by pressing the Conf key once.
6 Exiting a menu without saving the data.

Chapter 3: Design
3.2.6 Screens
 Description of the Ultrafiltration menu (example)
1 2 3 4
1 Status display
2 Card reader status (option)
(see Chapter 14.3.3 on page 14-23)
3 Network status (option)
4 Text display
5 Menu field
6 Menu bar
(shows the menus that can be selected via the screen)

Chapter 3: Design
 Description of screen colours
The currently selected menu and the text display are always displayed
as follows: white characters on blue background
The following colours 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 cannot be selected or changed
black white cannot be selected or changed

Chapter 3: Design
3.2.7 Using the menus – examples
 Example 1: Changing the venous alarm limit window
Dialysis menu
Use the arrow keys to select the Alarm
limits menu.
Press the Conf key.
Use the arrow keys to select the Position of

the venous alarm limit window.
Use the +/– keys to move the venous alarm

limit window.
Press the Conf key. The screen returns to the

Dialysis menu.

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.

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 Back- Charac- OK Error

ground ters
prior to the blue white

test
during the green black

test
successful- blue white 

ly complet-
ed
failed red white 
skipped red white 
Moreover, the test step currently in progress is shown in the text field.

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 the recorded treatment parameters.
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 Profiles

1
graphic will be displayed:
2 1 The desired sodium value (black
dashed line)
3
2 The actual sodium value (blue)
4 3 The UF volume already removed
(yellow)
4 The desired UF rate (black)
1 If only an Na profile is selected, the Profiles

graphic will be displayed:
2
1 The desired sodium value (black)
3
2 The actual sodium value (blue)

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

Chapter 3: Design
If both a UF and Na profile are selected, the

1 Profiles graphic will be displayed:
2 1 The desired sodium value (black
3 dashed line)
4 2 The actual sodium value (blue)

(yellow)
6 4 The desired UF rate (black)
Except for Single-Needle mode, the Pressure
Recording graphic will display the following:
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 representation of the blood

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

Chapter 3: Design
Graphical representation of the OCM data
Graphical representation 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 set or changed.
In the Base Na+ field, the value indicated on
the canister has to be entered.
In addition, the Empty BIBAG function can
be selected.

Chapter 3: Design
 Ultrafiltration menu
The Ultrafiltration menu displays the

ultrafiltration parameters.
With the exception of Max. Rate, UF Volume
and ISO Volume, all other parameters can be
set or changed.
 Treatment mode
This menu allows the selection of the

following treatment mode:
– SN - click - clack
If ven. window pos: ON is activated in the
SETUP:
The minimum value that can be set for the
lower venous alarm limit can be changed.
Select Venous window position using the
arrow keys in the Lower Limit window.
Use the +/– buttons to set the lower venous
alarm limit to +20 mmHg (factory setting) or
–60 mmHg.
Use the Conf key to save.
Depending on the equipment fitted on the
device and the device setting (see Chapter 5
on page 5-1), the following systems can be
selected in the Alarm system window:
– Acute alarm system (factory setting)
– Standard alarm system.
system window.
Use the +/– keys to set the desired alarm
system.

Chapter 3: Design
 Alarm limits menu
The Alarm limits menu can be used to

activate or deactivate the Reinfusion and
Needle Adj.Pgm functions.
This menu also includes the fields for
changing the position and size of the arterial,
the venous and the TMP alarm limit window.
 System parameters
The following settings can be defined in the

System parameters menu:
– Delete treatment parameters
– Brightness
– Auto-On Program:
The Auto-On can be set to start one of the
selected cleaning programs or the T1 test.
The start time of the Auto-On can be set
individually for each day of the week.
– System Time:
setting the current date and time
If a connection to an external system
(e.g. TDMS) exists, the System Time is
synchronised with the system time
configured to this external system
(e.g. TDMS).
Setting the system parameters:

Use the arrow keys to select the desired
parameters.
– Delete treatment parameters:
Set Yes using the +/– keys.
– Brightness:
Can be changed using the +/– keys.
– Auto-On Program:
Use the 0–9 keys or the +/– keys to set the
desired program and time.
– Use the 0–9 keys or the +/– keys to set the
desired date and time.

Chapter 3: Design
Auto-On Program The bibag® can be connected to the device following the successful
completion of the last disinfection of the day (72 hours is the maximum
time allowed prior to the next treatment).
If you wish to use this option, the following notes must be observed:
Requirements:
– Pre-program the T1 test in the Auto On menu.
(Observe the time programming of the osmosis unit.)
– CDS for acid connected.
Warning
After removing the foil, immediately connect the bibag® using aseptic
techniques. Then close the bicarbonate flap.
 Dialysis representation
In the Dialysis representation menu,

several diagrams can be selected. For
example, it is possible to record the arterial /
venous pressure and the blood pressure
values displayed 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 at double
the size. (Factory setting: Upper Selection 1,
Lower Selection 2)
The cumulated blood volume and the
effective dialysis time are shown in the
Dialysis data window.
Setting the diagrams:

Use the arrow keys to select the Upper
Selection or the Lower Selection.
desired diagram.

Chapter 3: Design
Display in the Dialysis menu , e.g. Profiles

and BPM.
Display in the Dialysis menu, e.g. Profiles

shown at larger size.
 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 shows:
– The Filter change function.
– The Last disinfection: function. Here the
date, the time and the last disinfection
program that was successfully completed
(arrow) are displayed.

Chapter 3: Design
 Cleaning process menu (e.g. Hot disinfection)
Each cleaning program has its own process

menu. This shows the Time Left and the
Temperature. Moreover, the cleaning
process is displayed graphically.
Yellow area: concentration of the disinfectant
Red-blue area: temperature curve
3.2.9 Description of the messages in the menus
 Alarm
High-priority alarm conditions.

The possible alarm messages 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.

Chapter 3: Design
 Warning
Low-priority alarm conditions

The possible warning messages 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
xxx
The possible info messages are listed in

Chapter 5, Alarm processing.

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 on the haemodialysis device!
The On/Off status indicator is illuminated.
The display shows the device type and the

current software version.
Internal RAM test
CRC test
Tests 24 V safety cut-off
(watchdog)
Alternating text display:
SCANNING CAN-BUS
4008S / V XX.X
The device is ready to use within one
minute.
Info message
Last disinfection:: Only if AutoOFF after AutoON is activated in
21.05.03 16:25 SETUP:
( Continue with [Conf] key )
Info message, if the last disinfection took
place more than 72 hours ago. The device
must be disinfected.
Use the Conf key to confirm.
The Cleaning key can also be used to
select the Cleaning menu directly.

4.1.2 Blood pump self-test
Rate: ml/h (Ø:ml) LED segments,

red status indicator and
Start Operation (green) status indicator
Stop
light up for 1 second.
The tube 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) LED segments,

( :h.min)
Rate status indicator (red),
Bolus Start Operation (green) status indicator and
Stop
Stop time (green) status indicator
light up for 1 second.
The syringe size will be displayed.
The delivery rate will be displayed.
4.1.4 Concentrate supply
The mixing parameters preset in the SETUP and in the dialysate menu
must match the information on the acid or acetate canister. This also
applies to the concentrate composition when using the CDS. Other
dilutions could present a risk to the patient.
Ensure that the concentrate containers used contain sufficient
concentrate to complete the treatment.
For bicarbonate dialysis with liquid bicarbonate concentrate (canister),
only the following concentrates can be used:
– an acid concentrate suitable for bicarbonate dialysis according to the
prescribed dilution (canister or CDS); or
– basic bicarbonate concentrate with 8.4% sodium hydrogen
carbonate (canister).
For bicarbonate dialysis with dry bicarbonate concentrate (bibag®), only
the following concentrates can be used:
– an acid concentrate suitable for bicarbonate dialysis according to the
prescribed dilution (canister or CDS); or
– bibag® manufactured by Fresenius Medical Care.
Always dilute the bicarbonate concentrate and the acid concentrate
suitable for bicarbonate dialysis immediately before use.
The bibag® must only be used for one treatment.
After dilution, the contents of the bibag® must be used within 12 hours.
Discard any residual solution. The bibag® powder is non-pyrogenic.

4.1.4.1 Central Delivery System
 General notes
Note
When using the CDS, connect the concentrate suction tubes to match
the selected type of concentrate delivery (SETUP).
Standard SETUP settings: CDS OFF.
Press the Dialysate menu key to check the

setting.
Note
The dilution defined in SETUP is displayed in the Dilution: field:
– Gray field, white characters:
CDS dilution; the value cannot be changed
– Black field, white characters:
Canister dilution; the value cannot be changed
– Blue field, white characters:
Canister dilution; the value can be changed, depending on the
SETUP specification
The CDS can be deactivated if desired, see following description.
 Turning the CDS off

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

The dilution defined in the SETUP will be

displayed.
Use the arrow keys to select the Dilution:
field.
Use the +/– keys to set the dilution to 1+34.
Press the Conf key to confirm the dilution.
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) in the acetate
canister.
Leave the bicarbonate suction tube (blue) in
the rinse chamber or place it in the rinse
chamber if it is not already there.
Close the flap.

4.1.4.4 Bicarbonate dialysis

for acid and acetate (red) in the acid canister.
Insert the bicarbonate suction tube (blue) into
the bicarbonate canister.
Close the flap.
Warning
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 position.
Note
The bicarbonate suction tube must be inserted into the rinse chamber
during the bibag® treatment.
Removing the suction tube may cause the rinse chamber to overflow.

Note
The bibag® will be filled when the bibag® is connected and the
bicarbonate suction tube is in the rinse chamber.
 Bicarbonate dialysis with bibag®

for acid into the acetate canister.
Close the flap.
Lift the latch up and open the bibag® flap.
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).
Firstly this program removes all the air from
the bibag® and then starts the filling of the
bag with water.
4.1.5 T1 test
The T1 test is valid for 24 hours and a maximum of one treatment.

A longer therapy duration can be achieved by several sequential
treatments with a maximum of 24 hours each.
It is imperative to perform a T1 test before each treatment.
4.1.5.1 General notes
In the following cases, the haemodialysis device will request the

operator to perform the T1 test:
– after power on (not following a power failure).
The T1 test can be performed with or without previously installing the
tubing system.
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.
– No blood sensed by OD.
– The concentrate suction tubes are in the appropriate canister or, for
use with CDS, are properly connected depending on the type of
supply.
4.1.5.2 Start
 Automatic
The Test status indicator is flashing.

Internal tests.
Operation status indicator light turns yellow

(warning / info).
T1 test starts automatically.

The Test status indicator is illuminated.
If one of the starting conditions is not
fulfilled, an audible alarm will sound. Use
the Test key or the Audio paused 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 for this setting, proceed as
follows:
– Open the shunt interlock flap.
– Turn on the haemodialysis device.
– Start the T1 test.
– Close the shunt cover.

 Manual

If the Test status indicator is not
flashing, one of the starting conditions
for the test is not fulfilled.

(warning / info).
Press the Test key.

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.
 Start
Press the Prime key.

The Prime status indicator is illuminated.
Press the Start/Reset key to start
precirculation.
Precirculation can only be started after
completion of the display test.

(warning / info).
T1 Test Prime
Temporary text display
or
T1 Test Prime/Circulation
If a rinse volume has been defined in the

SETUP:
The screen returns to the display of the test
steps.

 Setting the delivery rate of the blood pump
Rate: ml/h (Ø:ml) The Operation (green) status indicator is

illuminated. The blood pump is rotating.
Start
Stop The arterial blood pump primes the tubing
system 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

or The blood pump stops as soon as the venous
bubble catcher is filled or at least after 1 to
5 minutes (depending on the setting in the
SETUP) or if the rinse volume programmed in
the SETUP has been reached.
steps.
Standard alarm system:

Operation status indicator with a stable red
light (alarm).
Acute alarm system:
Operation status indicator flashes red
(alarm).


The Audio paused status indicator is
flashing.
Audible signal
Cleared automatically.
It may be necessary to raise the level in the

venous bubble catcher.
Press the  key until the desired level has
been reached.
Press the Start/Reset key.

The blood pump starts and the venous
occlusion clamp opens. The solution is
recirculated.

The Audio paused status indicator is dark.

(warning / info).

steps.

 Interrupting priming of the tubing system
Rate: ml/h (Ø:ml) Press the Start/Stop key.

The Operation (green) status indicator is
Start
Stop dark.
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 step currently in progress is highlighted.
The test starts with the display test.
During the display test, the operator must
check the following:
– status indicator LED
– bar graph displays
– screen
– operation status indicator (traffic light)
– audible alarm

 Serial test
The test steps are performed consecutively.

Displays the currently active test step.
During the display test, the operator must
check the following:
– status indicator LED
– bar graph displays
– screen
– operation status indicator (traffic light)
– audible alarm
4.1.5.5 End
 With the tubing system not primed
T1 Test passed
The Dialysis menu then appears.
The Test status indicator is dark.


 With the tubing system primed
Preparation
Text display
The Start/Reset status indicator is

illuminated.
4.1.5.6 Malfunctions

flashing.
Audible signal
T1 Test failed
Text display
Press the Test key.

The error code is displayed in the Error field.

e.g. 1
Press the Test key.

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 error recurs, it will be displayed together

with the error code.
Note
The following error messages can be acknowledged with
the Test key:
– Skip Battery?
– Skip Diasafe?
Warning
If the message Skip Battery? is confirmed with the Test key, the
extracorporeal blood circuit will be stopped in case of an empty
rechargeable battery and a simultaneous power failure. Power failure is
not indicated either visually or acoustically by the device.

Skip Battery?
Example: Skip Battery?
Text display
Press the Test key.

Audible signal
Are you sure ?

Text display
Press the Test key.
If the problem persists, call service

support.
4.1.5.7 Interruption
The T1 test will be interrupted if one of the required starting conditions

is no longer fulfilled (see Chapter 4.1.5.1 on page 4-8).
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.


The On/Off status indicator is no longer
illuminated.
4.1.6 Blood pump
Warning
Rotation of the pump(s) with open doors
(blood pump, optional Single-Needle pump):
When the doors are open and the pump(s) are rotating, make sure that
no objects, such as fingers, hair or ball point pens, come into contact
with the pump(s) rotors (risk of injury).
4.1.6.1 Inserting the arterial tubing system
Rate: ml/h (Ø:ml) 1. Open the cover.

2. Press and hold the Start/Stop key until
Start
Stop the rotor stops.
1. Insert the tube segment on the left.

2
the rotor stops.
5
3. Insert the tube segment on the right.
4. Close the cover.
4
5. Connect the pressure measurement line
to the pressure port.

Connect the arterial tubing system to the

blood inlet port of the dialyser.
4.1.6.2 Setting the line diameter
Rate: ml/h (Ø:ml) Should the blood pump rotor be running:

Press the Start/Stop key.
Start
Stop
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 set the desired
value.
Start
(Pressing the key for more
Stop
change rate.)
Selectable range:
2 to 10 mm in 0.2 mm increments
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

4.1.7 Heparin pump
4.1.7.1 Positioning the slide carriage
Rate: ml/h (Bolus:ml) Press the  key.

( :h.min)
Rate The slide carriage moves to the top
position.
Bolus Start
Stop
Note
When the slide carriage moves to the top position, the bolus data is
reset to 0.
1. Connect a syringe filled with heparin to the

heparin line of the arterial tubing system.
2. Insert the syringe.
Rate: ml/h (Bolus:ml) Press and hold the  key until the slide
( :h.min)
Rate carriage is in the start position.
Bolus Start
Stop
Warning
The thumb rest of the syringe plunger must engage in the slide carriage.
Note
The syringe wings must be in the syringe wing slot.

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 set the desired
( :h.min)
Rate value.
Start
Bolus Stop than 3 seconds will accelerate the
change rate.)
Selectable range:
0.1 to 10 ml/h
in increments of 0.1 ml/h
Rate: ml/h (Bolus:ml) Press the Rate key to accept the set value.
( :h.min)
Rate The display will continue flashing until
the set value has been accepted by
Bolus Start
Stop pressing the Rate key.
During this time the heparin pump
delivers at the previous rate.
Note
The heparin dose must be administered as prescribed by the physician!
Note
Use the Bolus key to administer an initial heparin dose.

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
The Stop time (green) status indicator 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

( :h.min)
Rate (Stop time (green) status indicator 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 set the desired
( :h.min)
Rate value.
Start
(Pressing and holding the key for a
Bolus Stop longer time will cause the change rate to
switch from 1 minute to 10 minute
steps.)
Adjustment range: 0 minutes to 2 hours
in increments of 1 minute.
Rate: ml/h (Bolus:ml) Press the Clock key to accept the set value.
( :h.min)
Rate The display will continue flashing until
the set value has been accepted by
Bolus Start
Stop pressing the Clock key. During this time,
the stop time previously set remains
active.

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 status indicator
Stop time (green) 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
Bolus Stop dark.
Rate: ml/h (Bolus:ml) Confirm the function by pressing the Clock

( :h.min)
Rate key.
Start
Bolus Stop
dark, heparinisation will be continued
without the stop time.
4.1.8 Level detector
4.1.8.1 Inserting the venous tubing system
Connect the venous tubing system to the

blood outlet port of the dialyser.
Install the venous bubble catcher in the
bubble catcher holder.

Note
Place the clot catcher approx. 1 cm below the lower edge of the bubble
catcher holder.
Warning
Patient hazard by means of air embolism
The level detector must be clean and dry.
No ultrasound-conducting objects or media should be used.
Blood clots (coagulation) can cause an error failure of the level detector.
1. Open the flap to the right.

4
2. Manually open the venous occlusion
clamp and insert the venous line into the
optical detector.
3. Check that the line is correctly inserted
and close the flap.
4. Connect the venous pressure
measurement line to the venous pressure
port (Luer-Lock).
Warning
The tubing system must be correctly inserted into the venous occlusion
clamp and the optical detector. Never remove the tubing system from
the venous occlusion clamp or the optical detector during treatment.
4.1.9 Extracorporeal blood circuit
Regarding the regulations for the application of haemodialysis devices, the following has to be observed
before and during treatment:
The blood pump must be set to the diameter of the pump segment, refer also to the product label of the
tubing system. If a wrong tube diameter is set, this may cause significant deviations in the blood flow and
thus in the dialysis dose.

Warning
Aseptic technique:
Use aseptic technique for all blood-side connections and all
connections in the area where sterile solutions are to be used.
Warning
hydrophobic filters on the pressure lines.
The hydrophobic filters must be connected in such a way that there is
no ingress or loss of air, and there is no chance of the filters becoming
wet even in the event of pressure fluctuations.
If a hydrophobic filter has become wet, the tubing system must be
replaced.
pressure line can be connected (accessory available from Fresenius
Medical Care).
The blood in the pressure line must not be forced back using a syringe.
This could damage the hydrophobic membrane and therefore lead to
contamination.
In case fluid may have passed through the hydrophobic filter, the device
must be checked for contamination after the treatment has been
completed. If the device is contaminated, it has to be taken out of
service. All affected parts must be disinfected or replaced according to
the manufacturer's specifications before recommissioning the device.
Warning
Before treatment, check:
– The safe connection of all connection sites of the tubing system.
– The tightness of the tubing system during and after priming.
– If necessary, re-tighten the connections and replace the tubing
system.
– Check the protective caps are tight and tighten them if necessary.
– The lines for the supply of infusions should always be clamped,
except if they are needed.
– The absence of air in the tubing system as well as absence of kinks,
tensions and twists and the correct position of all fluid levels. The
lines must not be squeezed (risk of haemolysis during the
treatment). Always use the tube holders provided.
Warning
To be observed when working on the tubing system during
treatment:
If the position of the tubing system or of one of its components is
changed, the correct position of the entire tubing system must be
restored afterwards, particularly the correct position of the tube guides.

Warning
During treatment, check at regular intervals:
– The condition of the patient.
– The function of the device and of the extracorporeal blood circuit.
To protect the patient from a dangerous loss of blood into the
surrounding area, venous pressure monitoring is used as a safety
system for the extracorporeal blood circuit.
Pressure monitoring, however, cannot detect a loss of blood into the
surrounding area in every situation. This is particularly critical when
there is a venous needle dislocation or a small leak in the positive
pressure section of the extracorporeal blood circuit.
For this reason, the extracorporeal blood circuit must be checked at
regular intervals for leakages, especially the tubing system
connections and the venous access site.
– The tubing system for entry of air or possible loosening of the
connections. Particularly at connection points after the level
detector, negative pressure can permit air to enter the
extracorporeal blood circuit. This can be the case, for example,
when using Single-Needle Dialysis or central venous catheters.
– The fluid level in the venous bubble catcher. Correct the fluid level,
if required.
– The tubing system for absence of kinks, tensions and twists
(risk of haemolysis).
– All unused access and drain sites must be closed with the clamps
provided.
Warning
Venous alarm limit
Warning
Dialyser couplings
When connecting the dialyser couplings, check and make sure they are
tight. This must be checked at regular intervals during treatment.
Note
When drugs or infusions are administered via the arterial tubing system,
check that the fluids move freely through the dialyser. This is to ensure
that there is no loss of efficacy of the infused fluids.
Drugs must be administered only in accordance with the information on
the package insert.

Fig.: Double-Needle treatment tubing system
Prime the extracorporeal blood circuit with NaCl solution.

Fig.: Single-Needle treatment tubing system
4.1.9.1 Priming
Connect the arterial tubing system patient

connector to the NaCl solution.
Break the cone on the NaCl solution.
Connect the venous tubing system patient
connector to the rinse bag.


The Air Detector status indicator is
illuminated.

(warning / info).
Prime
Text display
RINSE-VOL: XXXX ml
Message displayed briefly if a rinse volume
has been defined in the SETUP.

4.1.9.2 Setting the delivery rate of the blood pump

illuminated.
Start
Stop The blood pump is rotating.
The arterial blood pump primes the tubing
The delivery rate can be changed by
the operator as desired.

Pressing the key for more
change rate.
4.1.9.3 Delivery stops
Prime end
As soon as the venous bubble catcher is
filled:
Rinsing starts automatically.
When the preset priming time has elapsed

and the venous bubble catcher has not yet
been primed:
been reached.
Press the Start/Reset key to start the Rinse

program.

Dialysis
Rinse-volume reached
When the preset rinse volume has been
reached and delivered into the collection bag,
and the blood pump stops automatically.
4.1.9.4 Interrupting the fill program

Start
Stop dark.
4.1.9.5 Premature termination
Press the Start/Reset or the Preparation 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 display on the monitor against the
conductivity display on the acid / acetate canister. (Observe the
settings for sodium and bicarbonate in the Dialysate menu!)

Warning
If the dilution was set in the SETUP to be individually adjustable, always
make sure:
– that the physiologic composition of the dialysate is correct before the
treatment.
– that the individually adjustable dilution and the bibag® function are
not used simultaneously.
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 dilution defined in the SETUP will be

displayed.
Use the arrow keys to select the Base Na+
field.
Base Na+.
Use the arrow keys to select the Prescribed
Na+ field.
Prescribed Na+.
Adjustment 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.
Consider that in addition to the bicarbonate component in the

ready-to-use haemodialysis solution, also acetate (CH3COO-) or citrate
(C3H5O(CO2)33-) contribute to the total buffer as they are metabolised
by the patient's body into bicarbonate (HCO3-). Regular monitoring of
the patients' serum bicarbonate levels is recommended.
Use the arrow keys to select the

Bicarbonate field.
Use the +/– keys to adjust the bicarbonate.
Adjustment range: –8 to +8 mmol
4.1.10.4 Setting the conductivity window
 Repositioning the conductivity window
Use the arrow keys to select the Position

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

Warning
The alarm limits of the conductivity display must be set around the
expected value.
The actual value of the conductivity display must have attained the
expected prescribed 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 must be checked.
 Centring the conductivity window around the actual value
Use the arrow keys to select the Centre

field.
Press the Conf key.

The alarm limits are centred around the
actual value.
4.1.10.5 Sample collection
1. Connect a syringe (e.g. 10 ml Luer-Lock)

to the Luer-Lock of the sampling valve.
This valve is located on the dialyser
supply line.
2. Press and hold the key.
3. Lock the key using the pin.
4. Draw back the plunger.
5. Release the pin. The pin will automatically
close the valve.

4.1.10.6 Connecting the dialyser
Warning
Shunt cover open
Open the shunt interlock flap.
Message: Warning
The Flow status indicator is flashing.
Connect the dialysate inlet tube to the

dialyser (on the venous blood outlet side).
Connect the dialysate outlet tube to the
dialyser (on the arterial blood inlet side).
Close the shunt cover.

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

4.1.10.7 Changing the dialysate flow
Note
The dialysate flow can be set for the following treatment during
preparation. The reduced flow of 300 ml/min (AdaptedFlow), however,
remains active during preparation.
Use the arrow keys to select the Flow field.

Use the keys 0–9 or the +/– keys to adjust the
flow.
300, 500 or 800 ml/min can be set
or

If "AdaptedFlow" is activated in the SETUP:

Using the arrow keys, select the Flow or
AdaptedFlow: field.
Use the +/– keys to set the flow and
AdaptedFlow:.
A fixed flow of 300, 500 or 800 ml/min
can be set.
AdaptedFlow: Factor 1.2
i.e. the dialysate flow is 1.2 times the
effective blood flow.
The result is rounded up to the
nearest 100 (e.g. effective blood flow:
300 ml/min x 1.2 = 360 ml/min.
Rounded up: 400 ml/min is set).
A significant reduction of the dialysate
flow (e.g. –20% of 500 ml/min) has only
a small effect on the diffusive clearance
and Kt/V, which can be compensated by
a higher effective blood flow. However, it
is recommended that the individual
treatment parameters be observed and
the influence of AdaptedFlow with OCM
be monitored.
In the SETUP, the factor can be set to
1.2 or 1.5 times the effective blood flow.
It is also possible to set the "Variable"
factor to between 1.0 and 2.0 in
increments of 0.1.
4.1.10.8 Changing the dialysate temperature

Temperature field.
Use the keys 0–9 or the keys +/– to adjust the
temperature.
Adjustment range: 35.0 to 39.0 °C
in 0.5 °C increments
Press the Conf key.

4.1.10.9 Rinsing the dialyser
If the dialyser is to be prepared with a UF rate:

Press the UF Menu key.
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.
desired rate.
Note
When no blood is sensed by the optical detector 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 status indicator is illuminated.

4.2 Treatment
4.2.1 Ultrafiltration
Note
If the dialyser was prepared with a UF rate, the UF volume must be
deleted.
4.2.1.1 Resetting the UF volume
On the screen, select the System

parameters menu.
Set Yes in the Delete treatment parameters
field using the +/– keys.
Note
All saved treatment parameters will be deleted with this function.
4.2.1.2 Entering UF parameters
The UF parameters UF Goal and UF Rate have to be entered using four

digits (e.g. UF Rate 0750 ml).
 Maximum input values
UF Rate max. 4000 ml/h (can be preselected for each DIP

switch)
UF Goal 9990 ml
UF Time 9 hours 59 minutes

 UF auto start
The ultrafiltration will start automatically as soon as the optical detector

senses blood.
The requirements are:
– The UF values goal, time and rate have been entered correctly.
– The UF auto start function has been activated in SETUP.
 Starting position
Press the UF Menu key to select the

Ultrafiltration menu menu.
If the treatment is to be performed using the

UF values displayed which were defined in
the SETUP:
Press the Conf key.
 UF Goal function with fixed rate

field.
UF goal.
field.
desired rate.
The UF time left will automatically be
recalculated.

 Goal function with fixed time

Left field.
desired time.
field.
desired UF goal.
The UF rate will automatically be
recalculated.
 Timer rate function (no UF auto start)

field.
Press the C key to set the UF goal to 0.
field.
desired rate.
Left field.
desired time.
 Rate function (no UF auto start)
Note
If only a UF rate is entered for ultrafiltration, check the UF rate displayed
in the Dialysis menu after saving to verify if it is plausible.
Note
If only a UF rate is entered for ultrafiltration, the stop time function of the
heparin pump will be turned off.


field.
Press the C key to set the UF goal to 0.
Left field.
Press the C key to set the time to 0.
field.
desired rate.
 Timer function (no ultrafiltration and no UF auto start)

field.
Press the C key to set the UF rate to 0.
Left field.
desired time.
After all parameters have been entered:

Press the Conf key.
4.2.1.3 Starting ultrafiltration / timer


4.2.1.4 Stopping / interrupting ultrafiltration / timer

The UF status indicator is dark.
The UF pump stops.
Timer showing the UF time remaining stops.
4.2.1.5 Continuing ultrafiltration / timer
Press the UF ON/OFF key again.

4.2.1.6 Changing UF values
Use the UF ON/OFF key to interrupt

ultrafiltration.
The UF pump stops.
Timer showing the UF time remaining stops.


Ultrafiltration menu.
Use the arrow keys to select the desired data

field.
desired value.
All other parameters will be calculated
automatically.
Use the UF ON/OFF key to continue

ultrafiltration.

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.
Start
Stop dark.
The arterial blood pump stops.
Connection with volume bolus:

Connect the arterial and venous tubing
system to the patient.
Connection without volume bolus:
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.
Start
Stop illuminated.
There will be a soft-start of the blood
pumps (provided there is no blood
alarm)
The optical detector senses blood.

(warning / info).
Preparation end Text display
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.

Warning
Make sure that the TMP monitoring limits are narrow when using
high-flux dialysers.
The blood pump stops.

The venous tube clamp closes.
Audible signal
The Start/Reset status indicator is flashing.
flashing.
patient (unless this has already been done).
Check the level in the venous bubble catcher

and adjust, as necessary.
4.2.2.2 Performing the dialysis

illuminated.
If UF auto start is configured in the
SETUP:
The ultrafiltration starts automatically
with the parameters entered.
Text display
Dialysis Operation status indicator shows green light

(operation).

Warning
When using high-flux dialysers and selecting low UF rates there is a
possibility of backfiltration. Backfiltration depends on:
– the type of high-flux dialyser
– the different flow resistance values 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) status indicator is
illuminated.
The heparin pump is infusing.

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.

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 the bolus volume infused for
5 seconds.
(The bolus volume infused will be added
to the total, stored bolus volume.)
Then the delivery rate will be displayed.
Maximum bolus administration: 5 ml
Maximum total bolus volume:
1 x syringe contents
 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) Delete 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 deleted.
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.
 NaCl solution
If NaCl solution is introduced into the venous bubble catcher, blood may be diluted to such a degree that
no blood will be sensed by the optical detector.
No blood sensed by OD.

(warning / info).

No blood sensed by OD
Selection window
Continue treatment
Cancel treatment
The venous occlusion clamp closes.
Audible signal.
The alarm limits remain narrow.
Press the Conf key.

Dialysis will be continued with the alarm limits
centred 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 tubing system is connected with a Y-piece to the vascular access.
4.2.3.1 Selecting the treatment mode / entering treatment parameters
Use the arrow keys to select the Treatment

mode field.
Press the Conf key.

SN - click - clack field.
Use the +/– keys to set the window to ON.
Changing specified values:

Limit field, followed by the Lower Limit field.
Use the +/– keys to set the desired values.

Press the Conf key.
SN click clack
Text display
4.2.3.2 Changing treatment parameters / stopping treatment
Use the arrow keys to select the Treatment

mode field.
Press the Conf key.

Limit field, followed by the Lower Limit field.
To stop:
SN - click - clack field.
Use the +/– keys to set the window to OFF.
Press the Conf key.

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 switch off the

ultrafiltration.
2. Using the UF Menu key, call up the
1 Ultrafiltration menu.
Use the arrow keys to select the ISO Goal,

followed by the ISO Time.
If only the ISO time is set, the current UF
rate will be automatically calculated and
adopted.

desired values.
The ISO Rate field displays the calculated
ISO UF Rate.
Press the Conf key.
ISO UF start ?
Text display

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

The dialysate flow is automatically switched
to Off.
ISO R = XXX t = X:XX

Text display:
ISO Rate and ISO Time left
If only the ISO time is entered, only the
remaining ISO time left will be shown on the
display.
Note
When ISO UF is completed, dialysis will continue with the dialysate flow
and the calculated UF parameters.
Conductivity and temperature alarms 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.

Using the UF Menu key, call up the

Use the arrow keys to select the ISO Goal

field, followed by the ISO Time and ISO Rate
field.
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

ultrafiltration off.

Using the UF Menu key, call up the


field, followed by the UF Time Left field.
Press the Conf key.
Use the Flow ON/OFF key to turn the

dialysate flow off.
Flow - off
Text display
Audible signal after 30 minutes.
(Can be set in the SETUP: 30, 45,
60 minutes)


ultrafiltration on.

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
Warning
When using Na profiles, the following precautions must be observed:
The balancing neutrality of the profiles was computed for a dialysis dose
of the 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
maximum continuous UF rate:
Profile Rate (ml/h)
1 3000
2 3000
3 2660
4 2050
5 2050
6 1250

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

Use the arrow keys to select the UF Profile

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

Press the Conf key.

The Profiles field displays the profile number
in the yellow UF Profile circle.
Press the UF ON/OFF key to start the profile.
4.2.5.3 Entering a UF profile with sodium profile


field.
desired profile.
entered parameters.

Press the Conf key.

Press the Dialysate menu key to select the

Dialysate menu menu.
Use the arrow keys to select the Na Profile

field.
desired profile.
entered parameters.
Use the arrow keys to select the Start Na+

field.
Enter the Start Na+ with the 0–9 keys or the
+/– keys.
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.

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 set the profile to 0
(switch off).



field.
desired profile.
entered parameters.

field.
+/– keys.
Press the Conf key.
4.2.5.5 Entering a sodium profile with UF profile



field.
desired profile.
entered parameters.

field.
+/– keys.
Press the Conf key.


field.
desired profile.
entered parameters.

Press the Conf key.

4.2.5.6 End of program
UF goal reached
Text display
(warning / info).
The UF pump stops.
Audible signal

flashing.
TMP alarm limits go the end of the scale.

illuminated.
Info message
Reinfusion ?
Info message

4.2.5.7 Stopping the program

The UF status indicator is flashing.
Profiles paused
Text display
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
Retentate rinsing (approx. every 60 minutes
for 5 balancing chamber switching cycles)
Device is in bypass

4.3 End of treatment

(warning / info).
UF goal reached
Text display, e.g. UF goal reached
TMP alarm limits extend to the end of the

scale.
The UF pump stops.
flashing.
Audible signal.

illuminated.
Turn the heparin pump off, if necessary.

Info message
Reinfusion ?
Info message
4.3.2 Reinfusion
4.3.2.1 Procedure
Info message
Reinfusion ?
Info message
Press the Conf key.

The device will automatically switch to
the AdaptedFlow.

(warning / info).
Reinfusion
Text display
The arterial, venous and TMP alarm limits are

fully open for 5 minutes.
Disconnect the arterial patient line 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

Reinfusion starts (max. 5 minutes).
illuminated.
Dialysis end
Text display
Audible signal
To continue reinfusion:
illuminated.
Preparation
Text display
The blood pump starts.

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

Use the Start/Stop key to switch off the blood
Start
Stop pump.
dark.
Disconnect the venous tubing system from
the patient.
4.3.2.2 Repeating the reinfusion
Info message
Reinfusion ?
Info message
The reinfusion time has elapsed, before the
optical detector senses no blood.
Press the Conf key.
Reinfusion
Text display
Use the Start/Reset key to restart the

reinfusion.
illuminated.
If reinfusion is repeatedly started, there is a
risk of overhydrating the patient.

4.3.2.3 Skipping reinfusion
Info message
Reinfusion ?
Info message
Use the Start/Reset key to skip the reinfusion

function.
illuminated.
Dialysis
Text display
4.3.2.4 Stop

limits menu and access it 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
Text display

4.3.3 Stopping the treatment
4.3.3.1 Manually stopping the treatment
Use the UF ON/OFF key to switch off the

ultrafiltration.
Rate: ml/h (Ø:ml) Use the Start/Stop key to turn the blood
pump off.
Start
dark.
Reduce the delivery rate of the blood pump.
Break the cone.
Rate: ml/h (Bolus:ml) Switch off the heparin pump.

Rate
( :h.min)
Bolus Start
Stop dark.
Rate: ml/h (Ø:ml) Use the Start/Stop key to turn on the blood
pump with a reduced blood flow.
Start
illuminated.

(warning / info).

No blood sensed by OD
Selection window
Continue treatment
Cancel treatment
Audible signal
Empty the bibag® (see Chapter 4.4.2.1 on
page 4-86).
The alarm limits remain narrow.

flashing.
Use the  key or the  key to select the
Cancel treatment field.
Press the Conf key.

The device will automatically switch to
the AdaptedFlow.
or
Exit the selected Continue treatment field

(highlighted in green).
Preparation
Text display.


Start
Stop pump.
dark.
the patient.
4.3.3.2 Stopping treatment with the reinfusion program
Use the UF ON/OFF key to switch off the

ultrafiltration.

limits menu and access it 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
Text display
The blood pump stops. The venous occlusion
clamp closes.

The alarm limits are fully open.

illuminated.

Break the cone.
Rate: ml/h (Ø:ml) Press the  key to reduce the delivery rate of
the blood pump.
Start
Stop
Rate: ml/h (Bolus:ml) Switch off the heparin pump.

Rate
( :h.min)
Bolus Start
Stop dark.


illuminated.
The patient's blood is reinfused.
Dialysis end
Text display
Audible signal
Empty the bibag® (see Chapter 4.3.4 on
page 4-76).
To continue reinfusion:
illuminated.
Preparation
Text display
The blood pump starts.

Start
Stop pump.
dark.
the patient.

4.3.4 Emptying the bibag®
Dialysis end
Text display

illuminated.
Info message
Press the Conf key.
Emptying BIBAG
Text display
Emptying-program in progress.

Emptying of the bibag® can be skipped by

pressing the Start/Reset key again.
After emptying, lift the latch up to open the

bibag® flap.
Remove the bibag®.
At the operator’s discretion, the bibag® can
also be removed during emptying if
necessary.
Close the bibag® flap so that it clicks into

place.

4.3.5 Emptying the dialyser
Turn the dialyser so that the dialysate inlet

port is in the upper position.
Open the shunt interlock. Connect the
dialysate inlet tube to the coupling connector
on the right.
Close the shunt interlock.
Emptying-program
Text display
Open the shunt interlock as soon as air

bubbles are visible in the outlet tube.
Connect the outlet tube to the coupling
connector on the left.
Close the shunt interlock.
Remove the tubing system from the device.
Warning
After the treatment, consumables must be disposed of according to the
regulations for handling potentially contaminated materials.
Warning
It is imperative that the device is disinfected after each dialysis
treatment.

Warning
 Regular cleaning
Note
The following components require regular cleaning:
– the dialyser couplings and the shunt interlock
– the sealing area of the bibag® connector
– the sealing area of the concentrate suction tubes (concentrate /
bicarbonate)
Warning
A disinfection must be performed after having cleaned the
above-mentioned components.

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.
 Cleaning program (supplied from the front)
The Cleaning (front supplied) field displays

the number of cleaning procedures remaining
with Sporotal 100.
A maximum of 11 cleaning procedures with
Sporotal 100 is possible (display 11 to 1).

If no further Cleaning (front supplied)

procedures are possible, this option is no
longer shown in the cleaning menu.
The DIASAFE® plus can then be cleaned
using the programs which are still available
until the maximum number of treatments or
filter life is reached.
 When the filter life is exceeded
The Filter change program displays the

remaining number of treatment days allowed.
A maximum of 12 weeks is allowed. Only the
last 7 treatment days are displayed
(display: 7 to 1).
Filter change
only # day(s)
Info message, is displayed for the last 3
( Continue with [Conf] key ) treatment days only (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 on page 4-82).
or
Press the Esc key to override a filter change

 In the event of a T1 test failure
Filter change
T1 Test failed
Info message
Press the Conf key to perform a filter change
or
Press the Esc key to override a Filter
change (see Chapter 4.4.1.3 on
page 4-82).
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:
– Both dialysate tubes are in the shunt
interlock.
– The shunt cover is closed.
– The concentrate suction probes must be
locked inside the rinse chamber.

Warning
Observe the following rules of hygiene when inserting the
DIASAFE® plus:
– Only use filters with undamaged packaging.
– Only remove the packaging and protective straps immediately
before installing the filter.
– Only touch the connectors if required.
Note
A filter change must never be prematurely terminated, but must always
be properly completed.
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, 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 small flap.

1
1. Slide the 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 Instructions for
Use.
Warning
Disinfect the device after each filter change.

4.4.2 bibag®
4.4.2.1 Emptying bibag® (during treatment)
If the bibag® is empty or defective, it has to be replaced during the

treatment.
Use the arrow keys to select the Empty

BIBAG field.
Set Yes using the +/– keys.
Press the Conf key.
Emptying BIBAG
Text display
Emptying-program in progress.

The Emptying bibag® function can also be

started by unlocking (for approximately 1 to
5 seconds) and then re-locking the
bicarbonate suction tube.
The Empty BIBAG ? message must be
acknowledged with the Conf key.
Note
Do not remove the bicarbonate suction tube from its port to prevent fluid
leaking which then might enter into 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.

4.4.2.2 Connecting the bibag®
Lift the latch up and open the bibag® flap.
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 first removes all air from the
bibag® and then fills it.

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
– OD senses blood
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 the 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 selecting the
function in the SETUP.
If Online Clearance Monitoring has been started automatically, the
operator can cancel the measurement by using the OCM ON / OFF
menu option.
Warning
4.4.3.2 Manual start of Online Clearance Monitoring
Use the arrow keys to select the Dialysis

representation.
Press the Conf key.

Use the arrow keys to select the individual

OCM parameters and set the desired values
using the +/– keys or the 0–9 keys.
Entering V(urea) resets the fields for weight,
height, age and gender.
If V(urea) is unknown, a value for V(urea) will
be calculated from weight, height, age and
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 Measurement: 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 at any time. This message
can be confirmed using the Start/Reset key. If no valid value is entered,
Kt will be displayed instead of Kt/V.

representation.

Press the Conf key.

gender.
Note
Only the distribution volume of V(urea) needs to be entered in order to
calculate the Kt/V. If V(urea) is unknown, weight, height, age and
gender will be used to calculate a value for V(urea) by using an
empirical formula.
Maximum accuracy for the Kt/V calculation can be achieved only by
entering V(urea) 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

representation.

Press the Conf key.

gender.
The input 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
The operator can stop the OCM at any time by using the OCM OFF
option in the dialysis representation menu. It can be reselected.
However, values for Kt/V will no longer be calculated.

representation.
Press the Conf key.

Use the arrow keys to select the OCM.

Set OFF using the +/– keys.
Press the Conf key.

The treatment will be continued without
Online Clearance Monitoring.
4.4.3.6 Displaying the OCM graphics

representation.
Press the Conf key.
Use the arrow keys to change between the

two representations:
– Upper Selection
– Lower Selection
Use the +/– keys to select the desired
graphic.
If the same diagrams have been
selected in both fields or one is 0 No
Diagram, the other one will be displayed
in double size.

Press the Conf key.
 Parameters to be entered
Dry weight To calculate V(urea)

Height To calculate V(urea)
Age To calculate V(urea)
Gender To calculate V(urea)
V(urea) Entry in litres
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 unknown, the Watson
formula will be used to calculate this value from weight, height, age and
gender. 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
To calculate the dialysis dose Kt/V, the urea distribution volume V(urea)
must be determined. Ideally, it is determined by taking a clinical
measurement from the patient. In many cases, however, this value is
not available. In such cases, empirical formulas are used to determine
V(urea) from the patient’s gender, weight, height and age:
Formula 1: Watson formula Male patient: V(urea) = 2.447 – 0.095 • a + 0.107 • h + 0.336 • w
Female patient: V(urea) = –2.097 + 0.107 • h + 0.247 • w
The variables stand for:
V: Total water volume of the body

(equated with 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
formula will be used):

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

Hume-Weyers formula
If the patient’s height is not known, V(urea) is calculated solely from the
patient’s 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 that utilise the patient-specific parameters
of weight, height, age and gender.
The validity range of these formulae is restricted by the variation in
patient-related data. Accordingly, values for V(urea) that lie outside the
range of plausible values are replaced by values from 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
To precisely determine the dialysis dose (Kt/V), the distribution volume
V(urea) must be determined using 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, e.g. vascular diseases or other severe metabolic disorders,
and in paediatric dialysis, it must be expected that the accuracy will
vary.
Note
Do not use the rule of thumb according to the Hume-Weyers and the
Watson formulae for patients with concomitant diseases affecting the
expected urea distribution volume (e.g. amputation, severe
arteriosclerosis, atypical shift of the adipose tissue / muscle ratio).

 Preallocation, resolution and alarm limits of the input fields
Input field Default values Min. value Max. value Resolution
Dry weight -.- kg 20 kg 299 kg up to 99.9 kg: 0.1 kg

from 100 kg: 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

from 100 l: 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 input fields are reset to the default values by pressing the C key.
 Stopping Online Clearance Monitoring
OCM can be stopped at any time using the OCM OFF field in the
Dialysis representation menu. It can be reselected if the starting
conditions are fulfilled. However, values for Kt/V will then no longer be
calculated.
– The OCM measurement will be stopped automatically in the
following cases: 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).
– Power failure with empty rechargeable battery (OCM parameters
are deleted, OCM cannot be reselected during the treatment).
Once OCM has been stopped, the last values measured can be
displayed using the Dialysis representation menu for 15 minutes until
the device is turned off or the next program is selected. Then the values
will be deleted.

 Stopping the single OCM measurement
The single OCM measurement in progress will be stopped should any

of the following conditions occur:
– A blood alarm
– A bypass or water alarm (conductivity, temperature, water
deficiency)
– No blood sensed by OD. Kt/V is displayed, if available.
– The UF goal is reached. Kt/V is displayed, if available.
– UF Rate is changed by the operator
– Base conductivity is changed by the operator or indirectly
(by stopping the profile)
– Blood flow < 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
– Operator has changed a value in the dialysate menu (flow,
concentrate mixture or temperature)
If the OCM measurement pulse has not yet been started when any of
the above conditions occur, then the measurement will be repeated
when the conditions return to normal.
A measurement will be repeated within 12.5 min following a single
measurement that was in progress and had to be stopped, providing the
pulse is in the opposite direction to the last pulse. Otherwise the
operator must wait the 25 min until the next scheduled measurement.
 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

 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 entered for V(urea) . In this case Kt will be calculated
instead of Kt/V.
 Deleting the OCM data
OCM data items are deleted after selection and confirmation of a

cleaning program or the Delete treatment parameters menu option.
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 values 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.: # ml/min Shows the current Na clearance value.
Displayed for one minute after each
successful measurement.
Plasma Na: # mmol/l Shows the plasma sodium concentration of
the last single measurement for 1 minute.
Kt/V: #.# Shows the current Kt/V value. The value is
displayed for 1 minute if the UF goal has been
reached or no blood is sensed by the optical
detector.
Kt: #.# l Is displayed instead of "Kt/V:#.##" if a valid
value for V(urea) is not available. Shows the
current Kt value. The value is displayed for
1 minute if the UF goal has been reached or
no blood is sensed by the optical detector.
Kt/V: not available No Kt/V data is available as no successful
OCM measurements have been performed or
the calculation of Kt/V was stopped. The
value is displayed for 1 minute if the UF goal
has been reached or no blood is sensed by
the optical detector.

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

a dialysis treatment if the operator has not
previously entered V(urea) on the screen. It is
displayed immediately after the operator
activates OCM manually or as soon as the
optical detector senses blood, if OCM
Measurement: ON was preselected in
SETUP. This message prompts the operator
to enter the patient's urea distribution volume.
It only appears if V(urea) has not previously
been entered. If V(urea) is changed during
OCM measurement, Kt/V will be recalculated
if the latter is already available. The message
is cleared after confirmation with the
Start/Reset key.
SN <> OCM OCM cannot be started as a Single-Needle
treatment procedure (SN or SN-Click-Clack)
has been selected.
Profile <> OCM OCM cannot 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. # OCM cannot 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 senses blood if OCM is active due to
the default setting.
This message prompts the operator to
perform calibration of the OCM values.
The service technician must be informed of
the error code (#).
OCM off # 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 (#).
input value too low The operator tried to enter a value below the
minimum limit for the OCM parameters.
input value too high The operator tried to enter a value above the
maximum limit for the OCM parameters.
Warning message
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 calibrOCM 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

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 current Kt/V reached so far in the
treatment.
3 Urea clearance K (blue)
If no valid value is available for V(urea) , 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, display of Kt
(black), cumulated up to time – t. 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 window during a measurement
If the conductivity window is changed or centred during a measurement,

spreading of the limits will be undone and the single measurement
currently in progress will be stopped.
Note
Make sure that the window is properly positioned.
The CD window will be opened up for a maximum of 220 seconds to up

to ±17.5% from the mean value of the CD 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 stopped and to be
repeated later.

Chapter 5: Alarms
5 Alarms
Warning
Risk to the patient due to the repeated confirmation of a message
Repeatedly confirming a message when the cause has not been
remedied can endanger the patient.
 Remedy the cause before confirming a message.
The operator should at all times be able to hear and detect the visual
and audible alarms from the device.
 Alarm systems
Note
The responsible organisation must specify the alarm system. Check
that the alarm system used is suitable for the site and the ambient
conditions.
The device features the "Acute" and "Standard" alarm systems.

The device is supplied with the "Acute" alarm system as the factory
setting. The responsible organisation can ask the service support to
make changes to the alarm system.
 Operating status indicator
Different alarm reactions will initiate different reactions of the operating

status indicator.
Message Alarm system Alarm system

Operating status indicator "Standard" "Acute"
Alarm red (constant) red (flashing)
Warning yellow (constant) yellow (constant)
Info yellow (constant) yellow (constant)
 Audible alarms
Different alarm reactions will initiate different audible alarms.

Chapter 5: Alarms
Audible alarms Alarm system Alarm system

"Standard" "Acute"
Alarm Audible alarm (Standard) Audible alarm, high-priority
Warning Audible warning (Standard) Audible warning, low-priority
Info Audible info (Standard) Audible warning, low-priority
5.1 Alarm limits, management
5.1.1 Centring the arterial / venous alarm limits
The arterial and / or venous alarm limits are

not centred.
New Limits ?
Text display

Chapter 5: Alarms
Press the Start/Reset key again.

If the key is not pressed within approx.
8 seconds, the original alarm limits will
be retained.
The arterial alarm limits are centred around

the actual value.
Depending on the presetting in the SETUP:
The venous alarm limits are positioned
symmetrically or asymmetrically around the
actual value.
5.1.2 Centring the TMP alarm limits
The TMP alarm limit is not centred.

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

Chapter 5: Alarms
The TMP alarm limits are opened completely.
The TMP alarm limits are centred around the

actual value.
(Time delay depending on the UF
coefficient)
The TMP alarm window position might move

upwards automatically during the treatment.
5.1.3 Changing the arterial / venous / TMP alarm limits
Warning
Warning
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 adjustment of the window size is now deactivated.

limits menu.
Press the Conf key.

Chapter 5: Alarms
Use the arrow keys to select either the

Position or Size fields of the desired alarm
limit window.
Change the alarm limit window with the
+/– keys.
Press the Conf key.
The TMP alarm window position might move
upwards automatically during the treatment.
5.2 Needle adjustment
This function is to allow for the correction of the needles without unnecessary alarms. The arterial and
venous alarm limits are deactivated for 2 minutes. Both the high end scale alarm limit and the lower
20 mmHg limit remain active.
5.2.1 Start

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.

Chapter 5: Alarms
Needle Adj.Pgm
Text display

(warning / info).
The arterial and venous alarm limits are

flashing.
5.2.2 Stop

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.

Chapter 5: Alarms
5.3 Blood alarms
Warning
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

light (alarm).
Acute alarm system:
(alarm).

flashing.
The blood pump(s) stop(s).
The UF pump stops.
The staff call is active.
Audible signal
Alarm
Upper ven. alarm
Message: Alarm
e.g. Upper ven. alarm
Secondary alarm
A secondary alarm can be identified by the

status indicator:
– First alarm (e.g. venous pressure alarm):
status indicator is flashing
– Secondary alarm (e.g. TMP alarm): status
indicator is illuminated

Chapter 5: Alarms
5.3.2 Arterial pressure alarm
The Arterial Pressure status indicator is

flashing.
Cause:
The arterial pressure is outside the alarm
limits.
Alarm
Lower art. alarm
Message: Alarm
e.g. Lower art. alarm
new art limits ?

Text display
The alarm limits flash for 8 seconds.
The alarm limits are inactive.

be retained.

illuminated.
illuminated.

Chapter 5: Alarms
The arterial alarm limits are temporarily fully

opened.
The arterial alarm limits are centred around

the actual value.
5.3.3 Venous pressure alarm
The Venous Pressure status indicator is

flashing.
Cause:
The venous pressure is outside the alarm
limits.
Alarm
Upper ven. alarm
Message: Alarm
e.g. Upper ven. alarm

illuminated.
illuminated.

Chapter 5: Alarms
new ven limits ?

Text display
The alarm limits flash for 8 seconds.


be retained.
The venous alarm limits are temporarily fully

opened.
The venous alarm limits are centred around
the actual value.

Chapter 5: Alarms
5.3.4 TMP alarm
The TMP status indicator is flashing.

Cause:
The TMP is outside the alarm limits.
Alarm
Upper TMP alarm
Message: Alarm
e.g. Upper TMP alarm

illuminated.
illuminated.
new TMP limits ?

Text display
The alarm limits flash for some time,

depending on the determined UFC.

Chapter 5: Alarms

be retained.
The TMP alarm limits are fully open for some

time, depending on the determined UFC.
The TMP alarm limits are centred around the
actual value.
Warning
Sudden changes of the TMP are indicative of a defect.
5.3.5 Blood dimness warning
Warning
BLD-dimness-warning
Message: Warning
Causes:
– Dialysate side primed in dialysis mode.
– High post-deaeration caused by high
ultrafiltration rate.
– Dialysate drain line not connected tightly
enough.
– Poor pre-deaeration – air bubbles in the
dialysate inlet tube.
– Grease or calcium deposits.

Chapter 5: Alarms
Press the Start/Reset key (see

Chapter 5.5.3 on page 5-25).
In the event of grease and / or calcium

precipitate:
A disinfection program must be performed
after the treatment.
5.3.6 Blood leak alarm
The Blood Leak status indicator is flashing.

Cause:
Dialyser membrane rupture.
Alarm
Blood Leak
Message: Alarm
( Override with [Conf] key )
Press the Conf key.
Bld.leak overridden
Text display
Override time: 2 minutes each time the key is
pressed
Once the leak is sealed the status indicator
will be turned off.
If not, replace the dialyser.

Chapter 5: Alarms
5.3.7 Blood pump alarm
Alarm
Bloodpump-stop
Message: Alarm after 30 (15) seconds.
Rate: ml/h (Ø:ml) The status indicator (red) on the blood pump
is illuminated.
Start
Stop Error message displayed on the blood pump
E.XX.
Start
Stop
Note
If the problem persists, call service support.
5.3.8 Level detector alarm
The Air Detector status indicator is flashing.

Cause:
Air or blood foam in the venous bubble
catcher.

Chapter 5: Alarms
Press the  key to raise the level in the

The venous occlusion clamp is closed,
the delivery rate of the blood pump is
reduced to 100 ml/min.
5.3.9 Blood pump stop alarm
Alarm
Bloodpump-stop
Message: Alarm
Rate: ml/h (Ø:ml) The status indicator (red) on the blood pump
is illuminated.
Start
Stop Cause:
The blood pump rotor has stopped for more
than 30 (15) seconds.

Chapter 5: Alarms
5.3.10 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 status indicator (red) on either the arterial
blood pump or the SN blood pump module is
Start Start illuminated.
Stop 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 status indicator is dark.
Warning
hydrophobic filters on the pressure lines. If a hydrophobic filter has
become wet, the tubing system must be replaced.
pressure measurement line can be connected (accessory available
from Fresenius Medical Care).
If the pressure measurement unit is contaminated, all affected parts
must be disinfected or replaced.

Chapter 5: Alarms
2 1. Remove the SN pump segment.

2. Disconnect the SN pressure
measurement 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

The blood pump starts rotating.

Chapter 5: Alarms
Use the syringe to drain the fluid from the

compliance chamber while the arterial blood
pump is rotating.
Rate: ml/h (Ø:ml) Rate: ml/h (Ø:ml) Use the Start/Stop key to stop the arterial
blood pump.
Start
Stop
Start
dark.
1. Clamp the SN pressure measurement line

before the hydrophobic filter.
2. Connect the replacement pressure
measurement line to the additional
1 connection port.

Chapter 5: Alarms
1. Connect the SN pressure measurement

line to the SN Luer-Lock highlighted with
the white marking.
1 2. Insert the SN pump segment.
Press the SN key.

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

illuminated.

Chapter 5: Alarms
5.3.11 Cycle alarm in Single-Needle Click-Clack mode
Alarm
Cycle alarm
Message: Alarm
The Venous Pressure status indicator is

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

illuminated.
5.4 Dialysate alarms
5.4.1 Indication of alarms

light (alarm).
Acute alarm system:
(alarm).

Chapter 5: Alarms

flashing.
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
Audio paused key (factory setting).
The Flow status indicator is flashing: bypass
5.4.2 Conductivity alarm
The Conductivity status indicator is

illuminated.
The Flow status indicator is flashing, bypass
is active.
Cause:
The actual conductivity value is outside the
alarm limits.
Action required:
Ensure there is a concentrate supply.
Correct the problem causing the alarm.
5.4.3 Temperature alarm
Alarm
Upper temp. alarm
Message: Alarm
is active.
or
Cause:
Alarm The actual temperature value is outside the
Lower temp. alarm alarm limits.
Action required:
Wait until the desired temperature has been
reached or call service support.

Chapter 5: Alarms
5.4.4 Flow alarm
Alarm
Flow alarm
Message: Alarm
Cause:
– Kink in dialyser inlet tube, dialyser outlet
tube or drain line.
– Hydraulic defect.
Action required:
Check the tubes.
Call service support.
Alarm
Flow alarm
Message: Alarm
To confirm press the [Conf] Cause:
Key
The actual dialysate flow falls below the
preset value by more than 20%
Action required:
Check the tubes.
Press the Conf. key.
Note
The operator can decide if the treatment should be continued with the
reduced flow.
Alarm
Water alarm
Message: Alarm
is active.
Cause:
Water supply is disrupted.
Action required:
Check water supply.
Alarm
AdaptedFlow alarm Message: Alarm
To confirm press the [Conf]
Key Cause:
System error
Action required:
Press the Conf key.

Chapter 5: Alarms
Alarm
AdaptedFlow error
Message: Alarm
Cause:
AdaptedFlow was stopped.
Action required:
Press the Conf key.
Note
The dialysate flow goes up to 500 ml/min. AdaptedFlow is no longer
possible. The dialysate flow can still be set to 300, 500 or 800 ml/min.
5.5 Warnings
5.5.1 Indication of warnings
Messages can be displayed in the text display or as a window. The windows can either be warning or
information windows.
Example:
Warning
Wrong conc. supply
Message: Warning
Blood system and dialysate side are active.
5.5.2 Heparin pump warnings
Warning
Heparin pump not on
Message: Warning
The status indicator on the heparin pump is
dark.
First warning after approx. 11 minutes
Cause:
Heparin pump is not turned on.
Action required:
Press the Start/Reset key (no heparinisation)
or
switch on the heparin pump.

Chapter 5: Alarms
Warning
Heparin pump warning
Message: Warning
The status indicator on the heparin pump is
dark.
Cause:
Heparin syringe has reached its end position.
Action required:
Press the Start/Reset key (heparinisation no
longer required) or
Insert a new syringe: (see Chapter 4.1.7.1
on page 4-21)
Warning
Heparin pump warning
Message: Warning
Rate: ml/h (Bolus:ml) The status indicator on the heparin pump is

( :h.min)
Rate illuminated.
Bolus Start
Stop Cause:
Error message on the heparin pump.
E.XX.
Action required:
Note
If the problem persists, call service support.

Chapter 5: Alarms
5.5.3 Warning / information messages
 Fill program
Fillprogram
Text display
Air in the dialysate system. TMP limits are
flashing and inactive.
Automatic air separation
Fillprogram end
Text display
Acknowledge Fillprogram end with the
Start/Reset key.
Warning
If the message appears repeatedly or permanently, cancel the dialysis
treatment and call service support.
If this is not performed, a balancing error (wrong UF volume) may occur.
 Messages
Message Cause Possible solution First Repeti-

warning tion
24 V Switched Off The watchdog relay has Use the On/Off key to turn – –
been switched off. the device off and on
again.
ASP failure ! Air separation pump has Acknowledge with – –

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

Chapter 5: Alarms

warning tion
BLD-dimness-warning Blood leak detector Acknowledge with – –

contaminated or large Start/Reset.
amounts of air in the
Perform a cleaning
dialysate system.
program.
See also the Fillprogram
message.
CPU-II failed System error Use the On/Off key to turn – –

the device off and on
again.
Dialines not conn The dialyser couplings are Connect the couplings to approx. approx.
still in the shunt interlock. the dialyser. 9 min 9 min
Dialysate lines not The dialyser couplings are Insert the dialyser – –
connected not connected to the shunt couplings into the shunt
interlock. interlock and wait for
3 min.
Wrong conc. supply Incorrect concentrate Ensure there is a – –

composition. concentrate supply.
Error on the RCU ! Incorrect remote control Press the Start/Reset – –

information. key.
Hep.-Modul error E# Interrupted Press the Start/Reset key – –

communication between (see Chapter 5.5.2 on
the heparin pump and the page 5-23).
monitor.
Heparinisation will be
continued without a stop
time.
Flow - off warning The dialysate flow was Press the Start/Reset key 30 min 30 min
turned off. (if no dialysate flow is 45 min 45 min
temporarily required) or 60 min 60 min
switch the dialysate flow (SETUP) (SETUP)
on.
Funct. not allowed Is always displayed if a Observe the operating – –

function is not possible. sequence.
F# UF failure UF pump or control Press the Start/Reset – –

defective. key.

Chapter 5: Alarms

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

(if no UF is temporarily 30 min 30 min
required) or turn (SETUP) (SETUP)
ultrafiltration on by
pressing the UF ON/OFF
key.
Connect Conc.Line No concentrate Ensure there is a – –

connected. concentrate supply.
Check Concentrate ! Concentrate canister Connect a new – –

empty concentrate canister.
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 the dialysate system Turn the flow on. – –
With ISO-UF:
Switch off the UF and then
ISO-UF.
MODULE Error Malfunction in hydraulic Call service support. – –

processing unit.
Profiles paused Profiles have been Restart the profiles or 10 min 10 min
paused. keep them paused by
pressing the Start/Reset
key.
Profile time diff. Difference between the Press the Start/Reset key – –
UF and profile times. or stop the profile.
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.
RCU Keyboard Error Incorrect remote control Press the Start/Reset – –

information. key.
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 stops.

Chapter 5: Alarms

warning tion
set UF rate The UF goal can not be Turn the UF off. Adjust the – –
reached within the UF parameters (e.g. UF
remaining UF time left and rate).
the UF rate set.
UF goal reached UF time elapsed and UF Press the Start/Reset – –

goal reached. The UF key.
pump stops.
UF parameters ? The UF values were not Use the Conf key to – –

entered completely. acknowledge.
To confirm press the
[Conf] Key Correct the UF values, 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 error recurs, call
service support.

Chapter 5: Alarms

warning tion
Relation BPR/UFR ? The ultrafiltration rate is Press the Start/Reset 2 min (for 30 min
too high in relation to the key. SN)
delivery rate of the blood
Reduce the ultrafiltration 30 s (for
pump.
rate or increase the blood double-
pump rate. needle)
Cyclic PHT F# Leakage in the balancing Use the Start/Reset key approx. approx.
system during dialysis. to acknowledge, knowing 13 min 3 min
Attention! Possible
that a balancing error may
balancing error Bypass active and the UF
occur.
is off
If the test is failed
repeatedly, cancel the
treatment and call service
support.
If this is not performed, a
balancing error can occur.
Cyclic PHT F04 Blood alarm persisted for Use the Start/Reset key approx. approx.
more than 3 minutes. to acknowledge, knowing 15 min 6 min
Attention! Possible
that a balancing error may
balancing error or
occur.
The cyclic pressure
If the test is failed
holding test could not be
repeatedly, cancel the
performed (device error).
treatment and call service
support.
If this is not performed, a
balancing error can occur.
5.6 Power failure
5.6.1 Power failure and battery operation
Note
In the event of a brief power failure with a full battery, the alarm limits
set individually by the operator are stored. The alarm limits are used
again when the power returns.
If the battery is depleted, the alarm limitsare set as at the start of the
treatment when the power returns.

Chapter 5: Alarms

light (alarm).
Acute alarm system:
(alarm).
Audible signal
The hydraulics are off.
The UF pump stops.
Depending on the charging status of the
rechargeable battery, the extracorporeal
blood circuit is maintained.
Following a ACCUMULATOR EMPTY !
warning message, follow the instructions as
given in the chapter "Power failure and
depleted rechargeable battery" (see
Power Failure
Text display

illuminated.
flashing.

Chapter 5: Alarms
Press the Audio paused key.

Operation status indicator yellow
(warning / info).
illuminated.
The Audio paused status indicator is no
longer illuminated.
No audible signal.
In the event of a prolonged power failure, the
treatment must be discontinued.
Upon power return continue the program as
usual.
5.6.2 Power failure and depleted rechargeable battery
In the event of a power failure and,

simultaneously, a depleted battery, the
extracorporeal blood circuit is stopped. No
visual or auditory signals are emitted by the
device.
The extracorporeal blood circuit must be
manually maintained.
Flip open the emergency handle on the hand
crank. The hand crank must only be turned
clockwise as displayed on the pump casing.
Remove the tubing system from the venous
occlusion clamp. In addition, remove the BP
segment for the BP (SN) from the blood pump
for Single-Needle operation!
When the power returns:
Fold in the hand crank. Reinsert the tubing
system into the venous occlusion clamp. In
addition, reinsert the BP segment for the BP
(SN) for Single-Needle operation.
Warning
In the event of a longer power failure, reinfuse the blood into the patient
using the crank. To do this, remove the venous patient access line from
the venous occlusion clamp. Visually check the tubing for air!
In addition, remove the BP segment for the BP (SN) from the blood
pump for Single-Needle operation!

Chapter 5: Alarms
5.7 Error messages during cleaning programs
5.7.1 Indication of errors
Indication of errors during cleaning programs:

light (alarm).
Acute alarm system:
(alarm).
Message: Alarm or Warning

The Cleaning status indicator is flashing.
flashing.
The dialysate flow is inactive.
Audible signal

Chapter 5: Alarms
5.7.2 Error messages
Message Cause Possible solution
Arterial pressure ? The arterial pressure is outside the Check the tubing system.
alarm limits.
(only for priming / Connect the tubing system.
precirculation during a
Clear the hydrophobic filter.
cleaning program)
Increase the blood pump speed
(> 100 ml/min).
Bic line not connected Bicarbonate connector is not positioned Place the bicarbonate connector in the
in the rinse chamber. rinse chamber.
Please Wait Disinfectant is drawn in via the Cleared automatically.

concentrate pump.
Bypass Valve failed Actual status of the bypass valve (on / Can be acknowledged by pressing the
off) does not match the desired status. respective cleaning program key.
CPU-II failed System error Use the On/Off key to turn the device
off and on again.
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.
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 free rinsing higher The rinsing procedure will be continued
than 40 °C. until the temperature is < 40 °C.
Dial. Valve failed Actual status of the dialyser valves (on Can be acknowledged by pressing the
/ off) does not match the desired status. respective cleaning program key.
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 for priming /
possible). After cleaning: perform the
T1 test. Call service support.
cleaning program)

Chapter 5: Alarms
Level Detect. failed Level detector test failed. The error can not be corrected in the
cleaning program (precirculation not
(only for priming /
cleaning program)
opt. Detector failed Optical detector test failed. The error can not be corrected in the
cleaning program (precirculation not
(only for priming /
cleaning program)
Filter change ! Error detected during the T1 test. Select another cleaning program or
(Pressure holding test failed.) carry out a filter change (see
Chapter 4.4.1.4 on page 4-82).
Maximum filter life exceeded.
If the filter is not changed, a treatment
Maximum number of permissible
will no longer be possible.
Sporotal disinfections reached.
Flow alarm Dialysate tubes kinked. Check the tubes.

Rinse Failure F01 V84 error Use the Cleaning key to acknowledge.
Rinse Failure F03 Call service support.
Rinse Failure F02 V84 error Use the On/Off key to turn the device
off and on again.
In disinfection program (PGM 5): In disinfection program (PGM 5):

The level sensor / concentrate fails to Connect a cleaning agent.
detect fluid.
Rinse Failure F# Error during the cleaning program Use the On/Off key to turn the device
off and on again.
Rinse Failure F07 Pressure drop on PSW 124. Call service support.
Error message may alternate with message DO NOT SWITCH OFF !!

Wait for 1 minute before turning the device off!
Rinse Failure F08 Pressure drop on PSW 123. Call service support.
Error message may alternate with 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.

Chapter 5: Alarms
Internal Error # Runtime error in the program. Use the On/Off key to turn the device
off and on again.
Conc. detected F01 Bicarbonate level sensor (204) shorted. Start a disinfection program after rinse /
hot rinse.
Conc. detected F02 Concentrate level sensor (202) Start a disinfection program after rinse /
shorted. hot rinse.
Conc. detected F03 Bicarbonate level sensor (204) and Start a disinfection program after rinse /
concentrate level sensor (202) shorted. hot rinse.
Conc line not conn Concentrate connector is not Place the concentrate connector in the
positioned in the rinse chamber. rinse chamber.
Shunt cover defect Dialyser tubes connected to the Change the tubing system.
alternating with dialyser although the haemodialysis
Check the dialyser couplings.
Change blood lines ! device is in a cleaning mode.
Check the shunt interlock.
(only for priming /
precirculation during a (If cleaning is possible without both
cleaning program) dialyser couplings being connected to
the shunt interlock:
call service support).
Power Failure Power failure during operation. The respective program can be
continued after power returns.
Upper Flow Alarm Cleaning flow increases to more than Can be acknowledged by pressing the
1000 ml/min. respective cleaning program key.
Blood Sensed by OD The optical detector senses blood Check the optical detector.
when a cleaning program is started.
Float-Switch Failure The lower switching point is not Can be acknowledged by pressing the
reached. respective cleaning program key.
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.
Rinse required ! The mandatory rinse was stopped. Select the rinse program.

Chapter 5: Alarms
High temperature Temperature > 41 °C Call service support.

during hot rinse:
Temperature > 90 °C.
Low temperature Temperature < 33 °C Call service support.

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 match the prescribed rate. respective cleaning program key.
V39 Failure V39 malfunction Call service support.
V91/V100 Failure The valve does not open. Call service support.
V99 Failure The valve does not open. Call service support.
V102 Failure V102 electrically opened. Call service support.
V104 Failure V104 electrically opened. Call service support.
V130 Failure V130 malfunction. Call service support.
V188 Failure V188 malfunction. Call service support.
Venous pressure ? The venous pressure is outside the Check the tubing system.
(only for priming / alarm limits.
Connect the tubing system.
cleaning program) Clear the hydrophobic filter.
Increase the blood pump speed
(> 100 ml/min).
Water alarm Float switch for t > 10 s low. Check the water supply.
Water alarm Float switch for t > 30 s high. Cleared automatically.


Chapter 5: Alarms
5.8 Error messages after turning power on
Empty or white screen BIOS test, ROM test or RAM test failed. Call service support.
F# Configuration Incorrect device configuration. Call service support.
Keyboard Error Key on the monitor pressed when Switch the device off and on using the
turning power on. On/Off key.
Short-circuit on the keyboard. Call service support.
Watchdog Error This error message can only occur Switch the device off and on using the
shortly after turning power on. On/Off key.
HPU Error E# Malfunction in hydraulic processing Switch the device off and on using the
unit. On/Off key.
5.9 Messages during treatment parameter transfer (option)
 Download messages
Download error 001 Optical detector does not sense clear Ensure basic requirements are fulfilled.
fluid.
Restart data transfer
(re-insert PatientCard).
Download error 003 PatientCard removed during download. Check whether the download has been
prepared on the server.
Insert the PatientCard.
Download error 005 Internal format error Call service support.
Download error 006 UF unit turned on during data transfer. Turn the UF off.
Download error 007 Not in Preparation operating mode. Ensure basic requirements are fulfilled.
Download error 008 Unacceptable patient name Enter the patient name.
(empty / contains only spaces).

Chapter 5: Alarms
Download error 009 Value range of the UF parameter Check external data.
exceeded.
Download error 010 Non-uniform profile numbers Check external data.

(UF profile / Na+ profile).
Download error 011 Value range exceeded for UF or Na+ Check external data.
profile number.
Download error 012 Value range exceeded for the dialysate Check external data.
flow.
Download error 013 Value range exceeded for Base Check external data.
Na+ / Prescribed Na+ or plausibility of
readjustment range ±(0–13) mmol.
Download error 015 Value range exceeded for the Check external data.
bicarbonate value.
Download error 016 Value range exceeded for the Check external data.
temperature.
Download error 018 Plausibility of UF rate, UF goal, UF Check external data.

time.
Download error 019 Value range exceeded or plausibility Check external data.
error for the Start Na+.
Download error 020 Block check of UF rate, UF goal, UF Check external data.
time, UF profile. Na+ profile, Base Na+,
Prescribed Na+, Start Na+.
Download error 021 UF profile data plausibility. Check external data.

Download error 022 Na+ profile data plausibility. Check external data.
Download error 026 Dialysate flow plausibility Change external flow setting or activate
(AdaptedFlow SETUP settings). AdaptedFlow in the SETUP menu.

Chapter 5: Alarms
Download error 027 Log error (date of birth) Call service support.
Download error 028 Log error (rec day) Call service support.
Download error 029 Log error (CRC) Call service support.
Download error 030 Log error (type) Call service support.
Download error 031 Log error (general) Call service support.
Download error 032 Log error (unexpected patient ID) Call service support.
Download error 033 Log error (unexpected session ID) Call service support.
Download error 034 Log error (session ID) Call service support.
Download error 035 ISO UF values programmed although Delete ISO-UF values.
UF values have been transferred.
Download error 036 Patient-specific treatment parameters Check external data.

incomplete.
 Network messages
Network error 001 MAC address on LP 1631 is corrupted. Call service support.
Network error 002 SETUP configuration incorrect. Call service support.
Network error 003 No physical connection to remote Check network cable.

terminal.
Contact the service support if
necessary.
Network error 004 No IP address (DHCP server) Call service support.
Network error 005 System error (connection Call service support.

establishment)
Network error 006 System error (send) Call service support.
Network error 007 Server not available. Check network connections to server.
necessary.
necessary.

Chapter 5: Alarms
necessary.
Network error 010 System error (buffer overflow) Call service support.
Network error 011 System error (incomplete data) Call service support.

Chapter 6: Cleaning / disinfection
6 Cleaning / disinfection
Warning
– Hot rinse – risk of burns and scalding

– Hot disinfection – risk of burns, scalding and caustic burning
– Disinfection – caustic burning
These risks arise at the following parts of the device which can be
touched, opened and detached:
– Concentrate and bicarbonate flap
– Concentrate and bicarbonate suction tubes
– Shunt cover
– Dialysate tubes and dialysate connectors
– DIASAFE® plus
– Water drain
– Vent (rear of device)
During hot disinfection / hot rinse, hot water or steam can escape
through the overflow.
These risks can be present until the respective cleaning program has
finished and the device has cooled down.
Warning
Risk of infection and cross-contamination
Disinfection of devices must be performed as specified in the
Instructions for Use. Effective disinfection or cleaning cannot be
achieved if unsuitable procedures are used.
Only the disinfectants and cleaning agents listed in chapter 8 may be
used.
In addition, using unsuitable disinfectants and cleaning agents may
result in damage to the device which affects its functionality.

6.1 General overview
Text display
(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 possible additional disinfections
Filter change program
Indication of date, time and program

for the last completed disinfection (arrow)
*1 Select Rinse or Rinse endless using the +/– keys.

*2 Select 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–, free rinse in progress).
 Explanation of abbreviations used
R Rinse
R endless Rinse endless
F Free rinse
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 time left shown during the cleaning programs are calculated values.
This time may vary depending on the ambient conditions.
Note
When pressing the Cleaning key, the Cleaning menu will display when
the filter needs to be changed (see Chapter 4.4.1 on page 4-80).
On request, comments are available concerning the test procedures by

which the effectiveness of disinfection has been proved.
6.2 Surface cleaning
After the treatment, the surface of the haemodialysis device and the
options used must be cleaned and disinfected with cleaning and
disinfectant solutions (see Chapter 8.2 on page 8-3). Do not use any
sharp objects for cleaning.
 Regular cleaning
Note
The following components require regular cleaning:
– the dialyser couplings and the shunt interlock
– the sealing area of the bibag® connector
– the sealing area of the concentrate suction tubes (concentrate /
bicarbonate)
Warning
A disinfection must be performed after having cleaned the above-
mentioned components.
6.3 Basic conditions for cleaning programs
– The dialysate tubes 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.
– 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 parameters will be erased when selecting a cleaning
program.
Warning
Contact of the DIASAFE® plus with organic solvents can affect the
properties of the housing material, potting compound and the
capillaries. Safe function can therefore not be ensured and the
manufacturer shall no longer have any liability (see DIASAFE® plus
package insert).
6.4 Disinfection, decalcification
Factory setting is Citrosteril or Diasteril. If a different disinfectant is

used, this setting must be changed by a technician.
6.4.1 Starting

disinfection program.
e.g. Hot disinfection
Press the Conf key.

6.4.2 Sequence
Screen display of the cleaning program in

progress.
Text display e.g. >F<HDIS–M–
The Cleaning status indicator is illuminated.

(warning / info).
The end of the program is indicated by an

audible signal and a flashing Audio paused
status indicator.
Selectable in the SETUP.

light (alarm).
Acute alarm system:
(alarm).
Warning
A check for residual disinfectant on the drain line of the haemodialysis
device is recommended.
If other test methods are applied, the responsible organisation is
responsible for this decision.
Warning
If Puristeril 340 or Puristeril plus are used for disinfection, 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).

Warning
After disinfecting with Diasteril, the following must be observed: after
termination of the rinse program (mandatory rinse), the haemodialysis
device must be checked for residual disinfectant using the pH test. In
case of a positive pH reaction (colour change, pH less than 4.1),
perform another rinse program for a minimum of 5 minutes. Then
perform a further test to determine the pH.
6.4.3 Stopping the program
Warning
Do not stop a disinfection program before its completion. Premature
termination will compromise the efficacy of the disinfection.
Info message
Terminate cleaning pgm ? Info message
( Press [Conf] to stop )
Press the Conf key.

>F<HDIS–M–
Alternating text displays
Mandatory rinse end Audible signal
flashing.
light (alarm).
Acute alarm system:
(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, even though the
canister is full.
Note
During the filter life time of the DIASAFE® plus, it can be cleaned with
Sporotal 100 a maximum of 11 times.
The cleaning process using Sporotal 100 is monitored by the
haemodialysis device (see Chapter 4.4.1 on page 4-80).

6.5.1 Starting
Use the arrow keys to select the Cleaning

(front supplied) program.
Press the Conf key.
Free rinsing
(warning / info).

Warning
Connect Disinfectant
Message: Warning
Audible signal
flashing.
light (alarm).
Acute alarm system:
(alarm).
Place the red concentrate suction tube into

the container with the cleaning agent
(Sporotal 100).
Press the Conf key.
Warning
Make sure that the container used contains sufficient cleaning agent to
complete the cleaning program.
Avoid aspiration of air.
Warning
Please Wait
Message: Warning
(warning / info).
Cleaning agent is drawn in.

Warning
Conc line not conn
Message: Warning
Audible signal
flashing.
light (alarm).
Acute alarm system:
(alarm).
the rinse chamber.
6.5.2 Sequence

progress.
Text display: –F>D(F)<M–

(warning / info).

status indicator.

light (alarm).
Acute alarm system:
(alarm).

Warning
Warning
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).
6.6 Hot rinse
6.6.1 Starting

Use the arrow keys to select the desired hot

rinse program.
e.g. Hot rinse
Press the Conf key.
6.6.2 Sequence

progress.
Text display, e.g. >F<HR–C–

(warning / info).

status indicator.

light (alarm).
Acute alarm system:
(alarm).

Info message
Press the Conf key.
>F<HR–C–
Free rinse end Audible signal
flashing.
light (alarm).
Acute alarm system:
(alarm).
Cleaning programs can also be stopped by

turning the concentrate or bicarbonate
suction tube.
Note
device.

6.7 Rinse
6.7.1 Starting
Use the arrow keys to select the rinse

program.
Using the +/– keys, select Rinse or Rinse
endless.
Press the Conf key.
6.7.2 Sequence

progress.
Text display: >R<

(warning / info).


status indicator.
Selectable in SETUP

light (alarm).
Acute alarm system:
(alarm).
Info message
Press the Conf key.
>R<
Please Wait approx. 20 seconds

>R<
Rinse end Audible signal
flashing.
light (alarm).
Acute alarm system:
(alarm).
Rinse programs can also be stopped by

turning the concentrate or bicarbonate
suction tube.
Note
device.
6.8 Priming during cleaning programs
6.8.1 Basic conditions


program.
e.g. Rinse
Press the Conf key.
6.8.2 Start
Press the Prime key for 1 second.


(warning / info).
Prime
Rinse-volume # ml
SETUP:
>R<
Text display, e.g. >R<

6.8.3 Setting the delivery rate of the blood pump

illuminated.
Start
The arterial blood pump primes the tubing
The delivery rate can be changed by the
operator as desired.

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.
Depending on the setting defined in the
SETUP.
or
Rinse-volume reached
Text display
SETUP.
For 2 seconds:
light (alarm).
Acute alarm system:
(alarm).
>R<
Text display


Audible signal
Cleared automatically after 2 seconds.

been reached.
6.8.5 Interrupting the fill program

The Operation (green) status indicator is no
Start
Stop longer illuminated.
6.8.6 Premature termination
Press the Prime key for 1 second.

Press the Prime key a second time to
continue priming.

6.8.7 Malfunctions
The Prime status indicator is flashing.

An error message is shown in the text display
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.
Warning
The dialyser couplings must be in the shunt interlock.

6.9.2 Preselection
Press the Start/Reset key for 1 second.


(warning / info).
Prime/Circulation
Precirculation will be started automatically
after priming has been completed.
>R<
6.9.3 Starting
Priming has been completed.

The blood pump stops, the venous
bubble catcher is filled.



(warning / info).
Circulation
>R<
6.9.4 Setting the delivery rate of the blood pump

illuminated.
Start
change rate.)

6.9.5 Delivery stops
When the rinse volume has been reached.
For 2 seconds:
light (alarm).
Acute alarm system:
(alarm).
>R<
Text display

Audible signal
Cleared automatically after 2 seconds.

been reached.
6.9.6 Interrupting precirculation

The Operation (green) status indicator is no
Start
Stop longer illuminated.

6.9.7 Premature termination

Press the Start/Reset key a second time to
continue precirculation.

Chapter 7: Functional description
7 Functional description
7.1 Description of the procedure
7.1.1 Hydraulic flow diagram 4008 S


Key 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 supply conc. valve
6 Level sensor 109 Temperature sensor
7 Conductivity cell 110 Conductivity 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 Dialyser valve 1 121 Central supply conc. connection point
24b Dialyser valve 2 123 Pressure switch for V102
25 Bicarbonate pump 130 bibag® drain valve
26 Bypass valve 132 bibag® conductivity 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 rod chamber 210 Filter (degassing orifice)
66c Float chamber
68 Balancing chamber Hydraulics measurement points
71 Filter / concentrate A Reduced water inlet pressure
72 Filter / bicarbonate B Balancing chamber loading pressure
73 Filter / dialysate, external C Flow pump pressure
74 Filter / UF D Degassing pump pressure
76 Filter / fill valve
77 Heat exchanger
78 Relief valve
84 Disinfection valve
85 Disinfectant 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

 Description
The hydraulics unit of the haemodialysis 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 dialyser. 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 orifice (89) are used to generate a negative pressure
to degas the water. The air is collected in the air separation chamber
(88c). From there, it is directed to the heater rod chamber (66b) via the
loading pressure valve (65), and then discharged into the atmosphere
via the float chamber (66c).
The preheated and degassed water is delivered from the air separation
chamber (88c) to the mixing point (205).
Concentrate containing acetate (or in bicarbonate-based dialysis acid
concentrate) flows from the concentrate suction tube (94) through the
air separator (201) and the concentrate pump (23) to the mixing point
(205). In bicarbonate-based dialysis, bicarbonate is transported via the
bicarbonate suction tube (95), the air separator (203), and the
bicarbonate membrane pump (25) to the mixing point (205). The
evacuation valve (188) and the bibag® drain valve (130) are provided
for air separation.
The conductivity cell (132) and the temperature sensor (133) measure
and monitor the bicarbonate conductivity.
At the mixing point (205) the appropriate concentrates are mixed with
the water. The dialysate then flows via the balancing chamber (68), the
DIASAFE® plus (114) and the conductivity cell (7) to the dialyser.
The DIASAFE® plus (114) retains pyrogenic substances and micro-
organisms.
In the conductivity cell (7), both the conductivity and the temperature
(temperature sensor 3) are measured and displayed on the monitor.
The temperature sensor (109) controls the temperature.
If the temperature and conductivity are within the alarm limits, the two
dialyser 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
dialyser valve (24) closes.
The integrity of the DIASAFE® plus (114) membrane is checked by
ventilating around the dialyser capillaries via the compressor. At the
same time, V43 will be opened against the atmosphere.
The retentate valve (189) is used to rinse retentate from within the
dialyser capillaries of the DIASAFE® plus (114).

The used fluid coming from the dialyser is monitored by a blood leak
detector (8). From there it flows into the chamber of the multifunction
block (88b). The fluid coming from this chamber is then 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 chamber (88b) of the
multifunction block (88). The pressure measured here is taken into
consideration when calculating 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
a closed loop the same volume flows into the circuit across the dialyser
from the blood as ultrafiltrate.
After the balancing chamber (68), the used dialysate is directed to the
drain via the outlet valve (30), the heat exchanger (77) and the drain
valve (87).
The heat exchanger (77) transfers some of the heat from the out-flowing
dialysate to warm the in-flowing cold water.
Larger amounts of air entering the system, as a result of major
degassing 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) sits in the dialyser inlet tube. Dialysate can be
removed using 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 tubes.
Measuring point A measures the water inlet pressure, B the balancing
chamber loading pressure, C the flow 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), the disinfection valve (84) and the
disinfection sensor (115). The disinfection sensor (115) is used to
detect the presence or absence of the disinfectant.
When using the CDS function (Central Delivery System), concentrate
containing acetate, or in bicarbonate-based dialysis acid concentrate,
flows via the concentrate delivery connector (121) and the concentrate
delivery valve (102) to the concentrate 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

The operator is not restricted to only using the central delivery system
for the concentrate. Other concentrates can be used by inserting the
concentrate suction tube into the canister. The dialysis device also
recognises the type of dialysis performed (acetate or bicarbonate
dialysis) and controls the concentrate or the bicarbonate pump
accordingly.
Note
Aspiration of concentrates from the canisters has priority.
With central delivery systems if the concentrate suction tubes are
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
Note
The responsible organisation is responsible for proper installation and
function of the CDS, the RO system and the fluid tubes leading from the
connection points to the device.
7.1.3 Description of bicarbonate dialysis
 Mode of operation
Either acetate or bicarbonate dialysis can be carried out using the

haemodialysis device.
The type of treatment is determined by:
– the concentrate(s)
– 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 water in the dialysis device.
The concentrate suction tubes are connected to the appropriate
canisters.
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 dilution can be varied. The desired ratio can be selected in the
Dialysate menu. Press the Dialysate menu key.
During bicarbonate dialysis, precipitation of insoluble calcium and
magnesium salts can occur. The device must 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 are inserted

into the rinse chamber located on the device.
 Concentrates for bicarbonate dialysis
The correct ion concentration in the dialysate can only be achieved

when using the concentrates appropriate for the mixing system.
– 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
Bicarbonate concentrate canisters cannot be stored once they are
opened.
– 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. Carbonic acid and sodium acetate
are produced.
With the pumps at standard setting, this results in the following ion
composition for:
– 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
– SK-F 003 (PGS 01) and 8.4% sodium hydrogen 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

Bicarbonate dialysis
(bicarbonate from
canisters)
Bicarbonate dialysis
(bibag®)

 Safety for bicarbonate dialysis
Safety of the procedure is ensured by:

– two independent volumetric mixing systems
– the temperature-compensated conductivity monitoring
– colour-coded suction tubes and canisters
– automatic detection of the adapted supply connections
Procedure The dialysate is continuously prepared from bicarbonate concentrate,

acid concentrate and RO 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.
Warning
Only the dedicated bibag® must be connected to the bibag® connector.

 Preparation of the dialysate (schematic)

for 4008 S
8
2
7
6
3
1 Via the balancing chamber to the dialyser

2 Bicarbonate pump
3 bibag®
4 Concentrate B (bicarbonate)
5 RO water
6 Concentrate A (acetate or acid)
7 Degassing pump
8 Concentrate pump

 Safety system
Measurement of the conductivity and the bypass function prevents the

wrong dialysate concentration from entering the dialyser.
Monitoring of the desired conductivity to within ±5% by setting alarm
limits provides a safeguard against errors in the mixing system.
In the event the composition of the dialysate is incorrect the conductivity
produced will be outside the alarm limits. The conductivity alarm
switches on bypass mode. Audible and visual alarms are triggered.
An initial error in the mixing system will be detected before the deviation
of the dialysate values from the desired 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 the water supply or in the CD: ±0.4 mS/cm

balancing chamber: change in total
concentration max. approx. 0.4 / Na: ±6 mmol/l
13.5 = 0.03 = 3% Bic: ±1 mmol/l
pH: ±0.05
Defect in the CD monitor: No deviation.

Incorrect display The error will be detected
during the next T1 test.
Defect in the CD monitor: No deviation.

Defective alarm evaluation The error will be detected
during the next T1 test.
Mistaking bicarbonate and acid CD outside alarm limits.

concentrate (Expected value!)
Minimised by colour coding of
the canisters.
Use of wrong concentrates CD: ±0.4 mS/cm

 Dilutions
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
VARIABLE SETTING1 – – – – – –
B* corresponds to Belgian bicarbonate

1
for detailed information refer to the Service Manual
Note
For treatment with the bibag®, the dilution 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
haemodialysis concentrates.
The total conductivity of the ready-to-use dialysate with the appropriate
dilution is indicated on each package of the acidic bicarbonate
haemodialysis 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.

Example A desired 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 desired sodium value of
102 + 38 = 140 mmol/l is preserved.
7.1.4 Description of the variation function
Two types of profiles are possible to improve the dialysis tolerance,

ultrafiltration and sodium profiles, which can be used either
independently or combined for example high ultrafiltration with or
without a high sodium concentration.
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 (OCM) function determines the

average effective Clearance (K) for urea, the dialysis dose Kt/V and the
Plasma-Na concentration during the dialysis treatment already.
 Restrictions
The following functions are not approved for use with OCM:
– Single-Needle
– Single-Needle Click-Clack

 Clearance K
K (in ml/min) corresponds to the average effective Clearance for urea.

It indicates the percentage of the blood flow, which is completely
cleared of urea.
 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 effective dialysis time
V distribution volume of urea
The quality of the Kt/V information content depends on the accuracy of

the individual parameters, i.e. primarily on the accuracy of the urea
distribution volume 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 adaptation 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 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.

 General notes on measurement parameters
Warning
7.1.5.1 OCM measuring procedure
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 automatically every dialysis
treatment.
During a measurement the conductivity of the dialysate entering the
dialyser 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, highest
value +17.5% from mean value of conductivity
window at start.
Minimum conductivity: 12.8 mS/cm, lowest

value –17.5% from mean value of conductivity
window at start.
A pre and post-dialyser measurement of the conductivity is performed

by two mutually independent temperature-compensated conductivity
cells.
1 Dialysate drain
2 CD cell (110)

3 Arterial inflow
4 Venous return
5 CD cell (7)
6 Dialysate inflow
7 Dialyser
7.1.5.2 Time schedule of an Online Clearance Monitoring
When the OCM is started, measurement cycles are generated at

regular intervals. Direction and course of the cycles depend on external
parameters such as the current conductivity values or the cyclic
pressure holding test (CPHT).
The measuring cycle starts with the CPHT. The conductivity must be
stable before the cycle can start. The conductivity must be continuously
stable for at least 60 seconds. Then the current conductivity will be
measured and the direction of the CD variation will be decided.
Following this 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 stabilise; 10 minutes measurement phase).
Fig.: Measurement over time (schematic)
Measuring cycle
CD variation
Waiting for CD
CPHT

7.1.5.3 Sequence of measuring cycles during treatment
The gap between two measurements can be freely chosen in

12.5 minute intervals. The shortest possible gap is 25 minutes. The
measurements are synchronised 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.
If only 12 minutes or less of UF time is remaining no further
measurements will be performed.
The direction of the CD variation is determined by the conductivity
before the measurement is 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 equal to these limits, the directions of the
measurements will alternate. With base conductivities of 13.9 to
14.6 mS/cm this will generate an alternating CD variation.
Base
conductivity
window
If the Online Clearance Monitoring is aborted or stopped during the

treatment and is then restarted, automatically the next measurement
will be in the opposite direction to the one immediately before the
measurement was stopped, 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 dialyser 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 2/3 of the mean value.

OCM diagram
CPHT
 Rinsing the DIASAFE
During Online Clearance Monitoring, the rinsing of retentate from the

DIASAFEplus filter is suppressed until the measurement is completed.
7.1.5.5 Safety during an OCM
Safety during the procedure is ensured by continuous temperature-

compensated monitoring of the conductivity.
7.1.5.6 Maintenance
The OCM PULSE calibration is performed according to the

Maintenance protocol for the OCM option.
7.1.5.7 Technical Safety Checks
The routine TSC 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-fibre filter. Its excellent filtering
characteristics can be attributed to the Fresenius Polysulfone®
membrane.
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 specified time it ventilates one side of the
filter membrane until the necessary pressure is achieved for the test.

Test valve The test valve is only open as long as the compressor ventilates the
filter membranes or builds up the test pressure.
Hydrophobic filter (111)

Vent valve (112) Filter / test valve (184)
Compressor (185)
Test valve (183)
DIASAFE® plus
Drain Balancing Level detector
chamber P Pressure transducer
valve
(114)
Cond. / temp.
(3/7/109)
Monitoring
(68) 2 (182) P Monitor for venous
pressure
transducer
(189)
Retentate valve
Venous bubble
Bypass
catcher
valve
Pressure transducer (9)
Flow pump (21)
(26) Level detector

UF pump (22)
Fill valve (43)
Dialyser valve 1
Dialyser
(24)
Venous occlusion clamp
Dialyser
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 capillary space of the DIASAFE® plus is
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.


Compressor (185)
Test valve (183)
DIASAFE® plus
Drain Balancing
chamber P Pressure transducer 2
valve
(114)
(3/7/109)
Cond. / temp.
Monitoring
(68) (182)
(189)
Retentate valve
Bypass
Pressure transducer (9) valve
Flow pump (21)
(26)
UF pump (22)
Fill valve (43)
Dialyser valve 1
(24) Shunt interlock
Dialyser valve 2
(24b)
P
 Dialysis
The fresh dialysate flows from the balancing chamber to the

DIASAFE® plus.
This is integrated in the hydraulic system in such a way that, in an
alarm-free condition (no dialysate alarm: V26 closed, V24 and V24b
open), the "fresh" dialysate flows via the filter membrane.
Ultrapure dialysate enters the dialyser 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.


Compressor (185)
Test valve (183)
DIASAFE® plus
Balancing Level detector
Drain
chamber P Pressure transducer
valve
(114)
(3/7/109)
Cond. / temp. Monitoring
(68) 2 (182) P Monitor for venous
pressure
transducer
(189)
Retentate valve
Venous bubble
Bypass
catcher
valve
Pressure transducer (9)
Flow pump (21)
(26) Level detector

UF pump (22)
Fill valve (43)
Dialyser valve 1
Dialyser
(24)
Venous occlusion clamp
Dialyser
valve 2
P P
(24b)
Arterial bubble catcher
monitor
Arterial blood pump
Arterial pressure
 Cleaning
During the cleaning programs the dialysate tubes (red / blue) are
connected to the shunt interlock.
Cleaning agents, water or disinfectants flow via the balancing chamber
to the DIASAFE® plus. The retentate valve (V189), V26, V24 and V24b
open alternately allowing fluid to flow not only through the inner capillary
space but also across the filter membrane.


Compressor (185)
Test valve (183)
DIASAFE® plus
Drain Balancing
chamber P Pressure transducer 2
valve
(114)
(3/7/109)
Cond. / temp.
Monitoring
(68) (182)
(189)
Retentate valve
Bypass
Pressure transducer (9) valve
Flow pump (21)
(26)
UF pump (22)
Fill valve (43)
Dialyser valve 1
(24) Shunt interlock
Dialyser valve 2
(24b)
P

7.2 Description of the extracorporeal blood circuit
1a External hydrophobic filter

2 Arterial pressure monitor
3 Arterial blood pump
4 Heparin pump
5 Arterial bubble catcher
6 Dialyser
7b Internal hydrophobic filter
8 Deaeration valve
9 Monitor for venous return pressure

10 Ventilation pump
11 Hydrophobic filter
12 Level detector
14 Optical detector
 Description
The arterial blood pump delivers the blood from the patient’s vascular
access to the dialyser. 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 occlusion clamp is closed, a visual and audible alarm
is emitted. Ultrafiltration is also stopped.
The heparin pump is used to administer heparin doses to the blood at
an adjustable rate. The stop time is a programmable time of between
0 minutes and 2 hours. It determines the time before the end of the
treatment when the administration of heparin is switched off.
After the dialyser, the blood enters the venous bubble catcher. Here the
venous return pressure is measured and monitored within narrow limits.
The monitor for the venous return pressure is separated by two
hydrophobic filters. The venous bubble catcher is located in the level
detector. The level detector protects against air infusion. If the level
drops or if there is blood foam in the venous bubble catcher, a blood
alarm is emitted: the arterial blood pump stops, the venous occlusion
clamp is closed, a visual and audible alarm is emitted. Ultrafiltration is
also stopped.
After the bubble catcher, through the blood passes the optical detector
(OD). It differentiates as follows:
– No blood sensed by OD (NaCl solution or air in the tubing system) or
– OD senses blood (blood in the tubing system).
From the optical detector, the blood is then returned to the patient
(via the venous needle).
7.2.2 Single-Needle Click-Clack dialysis
Note
This procedure should only be used in exceptional cases, since the
stroke volumes and, thus, the corresponding recirculation ratios can be
very unfavourable.
If the AdaptedFlow is activated, the dialysate flow will automatically be
set to 500 ml/min.

 Example of how to perform the 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 tubing system by selecting
SN-Click-Clack. After the limits for the switching pressure values have
been entered, the venous pressure transducer controls the blood pump
and the venous occlusion clamp. Both the arterial and the venous tubing
systems are connected to the remaining vascular access by means of
a Y-piece.
The venous occlusion clamp is closed while the arterial blood pump is
delivering blood. As soon as the upper limit on the venous pressure
transducer has been reached in the tubing system, the blood pump
stops and the venous occlusion clamp opens. The pressure which has
developed in the tubing system delivers the stored blood to the patient.
As soon as the set lower limit has been reached, the venous occlusion
clamp closes, the arterial blood pump starts, and the same procedure is
repeated at regular intervals.
If the cycle time is exceeded by 15 seconds, an alarm will be emitted.
The venous occlusion clamp is closed. Both the blood pump and UF
pump stop.

7.2.3 Single-Needle dialysis (option)

2 Arterial pressure monitor
3 Arterial blood pump
4 Heparin pump
5 Arterial bubble catcher
6 Dialyser
8 Deaeration valve
9 Monitor for venous return pressure
10 Ventilation pump
11 Hydrophobic filter
12 Level detector

14 Optical detector
15a External compliance chamber
15b Internal compliance chamber
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 double pump SN system, the mean blood flow is
calculated as follows:
QSN = (BPRart x BPRSN) / (BPRart + BPRSN)
[theoretical value]
The following approximation formula (rule of thumb) 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 stationary. The venous occlusion
clamp is closed. The external compliance chamber is connected to a
pressure transducer at 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 alarm limit, the arterial blood pump
stops. The SN blood pump starts and pumps the blood through the
dialyser, the venous bubble catcher and the venous occlusion clamp
into the patient. As soon as the pressure in the internal compliance
chamber drops below the set lower alarm limit, the described procedure
or cycle 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 dialyser prevents level
fluctuations in the venous bubble catcher. It also improves the stability
of the TMP.
The treatment success (clearance) depends on the effective blood flow
and the stroke volume. The higher the stroke volume, the lower the
amount of recirculation. 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.

All other components and their functions correspond to those already

described for Double-Needle dialysis.
The blood pump stop alarm is active on both pumps. Should one of the
pumps stop for longer than the set time (factory setting: 30 seconds), a
blood pump stop alarm will be emitted.
Note
The design (closed system) of the haemodialysis 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 cumulated 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 tubing system.
The actual blood flow (effective blood flow) may deviate slightly from
this value, because it depends on the different inlet 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 effective blood flow and the elapsed treatment time, the
monitor computes the cumulated blood volume. This information is
shown in the Dialysis menu in the Cum. Blood Vol. window.
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, settings instructions in the SETUP menu.)
Note
Flow alarms during cleaning programs will increase the length of the
cleaning programs by the duration of the alarms.
Note
If the dialysis 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 in the SETUP.
– If the cleaning program was stopped (e.g. suction tube twisted).

The following components and functions are monitored during the

cleaning programs:
– Dialyser valve
– Bypass valve
– Balancing chamber switching pulse (flow)
– Float switch
– UF pump
– Temperature
– Supply voltages 24 V and 12 V
– Software watchdog
– Shunt cover
– Dialysate tubes connected
– Concentrate and bicarbonate suction tubes connected
– CDS
– V84
– Retentate valve
7.3.2 Disinfection, decalcification
Warning
During these programs, the haemodialysis device is:

– thermally (heated) disinfected and decalcified (using Fresenius
Citrosteril or Fresenius Diasteril)
– disinfected and decalcified (using Fresenius Puristeril 340)
– disinfected (with Fresenius Sporotal 100)
The disinfection solution (Puristeril 340) and for hot disinfection
(Citrosteril or Diasteril) are connected on the rear of the device
(disinfection programs 1 to 4).
Irrespective of the canister connected to the rear of the device, the
special program 5 can be used if necessary to draw in a disinfectant
containing sodium hypochlorite (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.

Note
The heat disinfection program must 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 (front

rinse hot rinse 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: 800 ml/min Flow: 800 ml/min Flow: 800 ml/min Flow: 800 ml/min Flow: 800 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)–
Timer Timer
counter: counter:
from > 80 °C from > 80 °C
–M– –M– –M– –M– –M–
–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


Chapter 8: Consumables, accessories, additional equipment
8 Consumables, accessories, additional

equipment
Warning
Upon request, information on further accessories, consumables or

other additional equipment will be made available by the local service.
 The following versions of the haemodialysis 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 IFU)

2. Water inlet filter (cannot be used in combination with the "Integrated
hot rinse" function)

8.1 Single use item
Warning
The dialysers, tubing systems and disposable syringes specified in this
chapter are single use items.
They are marked with the symbol: 2 = do not re-use
 Dialyser
FX-Class High-Flux dialyser
Description Information Sterilisation
Fresenius FX 60 Surface 1.4 m2 INLINE steam-sterilisation
 Tubing system
Warning
In order to avoid cross infections via the pressure ports, the use of
hydrophobic filters is required.
Double-Needle dialysis:
Description Venous bubble catcher Sterilisation
AV-Set B-R 22 mm E-beam
Single-Needle dialysis:
Description Venous bubble catcher Sterilisation
AV-SN-Set B-R 22 mm E-beam
 Disposable syringes
Note
The 20 ml Fresenius heparin syringe (part number F00001255) has
been taken as a basis and released for calculating the delivery rate.
Syringes of other brands must not be used, as this could lead to severe
deviations in the delivery rate.

Description Information
Fresenius 20 ml heparin syringe (part number F00001255) Luer-Lock connector, latex-free.
8.2 Consumables
 Haemodialysis 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)
– 8.4% sodium hydrogen carbonate
– AC-F (1+44) in the canister
– Smartbag (1+44)
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
 NaCl solution
Appropriate NaCl solutions have to be used.
 Disinfectants
Solutions for disinfecting and decalcifying from the dialysate circuit
Warning
Observe the following information regarding disinfectants:
– the printed expiry date.
– the storage conditions for the disinfectant concentrates.
– the manufacturer’s instructions for use.

Warning
Prior to the use of disinfectants other than those listed here, their
efficacy and compatibility with the materials affected in the
haemodialysis 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.
Warning
The following must be observed when using Puristeril plus:
In case of treatments with High-Flux membranes, we additionally
recommend to perform a regular degreasing programme with
Sporotal 100.
Disinfection Dilution:
The container concentrate is diluted in the dialysis device with process
water in a ratio of 1+24 (cleaning programs 1–4) or 1+34 (cleaning
program 5).
Fresenius Puristeril 340
Water temperature in the cleaning program: 37 °C
Active substance base: Peracetic acid
Active substance concentration: Approx. 0.15% (diluted)
Fresenius Puristeril plus
Active substance concentration: < 0.1% (diluted)
Fresenius Sporotal 100

(only cleaning program 5)
Active substance base: Sodium hypochlorite

Note
During the filter life time of the DIASAFE® plus, it can be cleaned with
Sporotal 100 a maximum of 11 times.
The cleaning process using Sporotal 100 is monitored by the
Fresenius Citrosteril
Active substance base: Citric acid hydrate
Fresenius Diasteril
Active substance base: Hydroxyacetic acid
Note
must be programmed.
Decalcification
Fresenius Puristeril 340
Fresenius Puristeril plus
Active substance concentration: < 0.1% (diluted)

Fresenius Citrosteril
Active substance base: Citric acid hydrate
Fresenius Diasteril
Active substance base: Hydroxyacetic acid
Note
must be programmed.
Indicator for disinfectants
Warning
Potassium-iodide-starch paper
Detection of residual Puristeril or Sporotal

(violet colouring – iodine precipitation)
Warning
Use new (white) indicator paper.
Determination of the pH
Checking for Diasteril (pH test strips).
Warning
Test takes approx. 10 to 15 seconds. In case of a positive pH reaction
(colour change, pH less than 4.1), perform another 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: Wipe disinfection
DIASAFE® plus
Active substance base: Cationic tensides
Active concentration: See product description

0.5% – 1 hour
1.0% – 15 minutes
Fresenius Freka-NOL
Type of disinfection: Wipe disinfection combined with

Freka-Wipes disposable cloths
Active substance base: 45% ethanol
 DIASAFE® plus
Warning
Use only the original DIASAFE® plus made by Fresenius as already
described.
Observe the "use by" date printed on the packaging.
"Use by" symbol:

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 fastener) arm circumference 17 cm to 26 cm
Blood pressure cuff M35 969 1 Adults – standard,

Blood pressure cuff M35 974 1 Adults – thick arms,

Blood pressure cuff M35 975 1 Adults – thighs,

(Velcro fastener) circumference 42 cm to 50 cm
Blood pressure cuff M35 973 1 Children,

 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)

Chapter 9: Installation
9 Installation
9.1 Important information before initial start-up
The following information must be carefully observed to ensure safe

operation of the haemodialysis device:
Electrical unit
Warning
The "type of protection against electric shock" for this device is
"Protection class I". To avoid the risk of electric shock, this device
should only be connected to a power supply network with a protective
earth.
It must be taken into consideration that in many countries, regulations
have been specified by the national authorities.
Warning
Risk of injury caused by electric shock
A defective protective earth in the installation can cause an electric
shock.
 Ensure that the protective earth of the installation meets the
requirements of IEC 60364-7-710.
 Have specialist personnel check the protective earth connections of
the installation.
– The national standards and regulations must be observed when

connecting the device to the power supply.
– If the device is used in a domestic environment, the device
connection must meet special requirements. For further information
refer to the Service Manual.
Due to the permissible voltage tolerances, medical care in a
domestic environment with a mains voltage of 100 V is not
permitted.
– If the power cable is replaced, use only the original power cable
listed in the spare parts catalogue.
– Connect the equipotential bonding to the rear of the device if this is
required by the legal regulations at the place of installation.
Warning
Do not use multi-way sockets or extension cables.

Warning
When using central venous catheters, the following precautions must
be observed:
1. The dialysis device must be connected to the equipotential bonding.
2. If there are other electromedical devices on the patient or in their
tangible environment, it must be ensured that all leakage currents
from these devices (device leakage currents, housing leakage
currents, earth leakage currents and patient leakage currents) are
below the respective alarm limit for CF applied parts.
This means:
maximum 10 µA in normal conditions and 50 µA in the event of a
"first fault".
This also applies to patient positioning devices (e.g. patient
couches).
Devices which comply with these leakage current limits but use an
application current which is larger than the specified leakage current
values (e.g. stimulation current equipment) must not be used. This
also applies to defibrillators which do not have a floating type CF
applied part.
If all the conditions are fulfilled, such devices can be operated on the
patient or in their tangible environment if they are integrated into the
equipotential bonding like the dialysis device.
If these conditions are not fulfilled, no other electromedical devices
may be located on the patient or in their tangible environment.
If in doubt, consult the respective technician.
Leakage currents from an additional

electromedical device can flow
to earth via the central
venous catheter.
Catheter
Dialysis device Additional

electromedical
device
All types!
(B / BF / CF)
Housing
leakage currents
of all types
The patient is are 10 times higher than
electrically "CF" patient
connected leakage current!
to the earth
potential
via their blood and
the dialysate.

3. A room from Group 1 is sufficient for the room version. This means
that the mains can be switched off in the event of a first fault, and the
treatment can be stopped or repeated.
Furthermore, the room must be equipped with an equipotential
bonding. For further information, refer to the national standards and
regulations (e.g. DIN VDE 0100-710 in Germany).
– If additional equipment, which is not included in the accessories, is

connected to the dialysis device, there is a danger that the
permissible leakage currents will be exceeded.
– Do not use devices emitting electromagnetic radiation (e.g. walkie-
talkies, portable phones, radio transmitters) in the vicinity of dialysis
devices in operation. This may cause a dialysis device malfunction.
 Rechargeable battery
Maintenance of the Upon receipt of the haemodialysis device, the integrated rechargeable
integrated rechargeable batteries must be charged as follows:
battery – Connect the device via the power cable to the electricity.
– Then switch on the device for approx. 10 hours.
If the device is not used, repeat this procedure every six months.
 Water supply
Warning
The responsible organisation is responsible for proper installation,
function and quality of the hygiene of all connectors and ports, such as
the water supply, the RO unit, and the Central Delivery System,
including the fluid tubes running from the connection points to the
device.
Warning
When using an RO unit or CDS, please note the following:
Instructions for Use of the RO unit or CDS used.
When cleaning the RO unit and its supply lines, the haemodialysis
device must be disconnected from the RO unit at the water supply.
During cleaning of the CDS supply lines, the haemodialysis device must
be disconnected from the CDS.
To ensure that the water quality is always as good as possible, regular
checks and, if necessary, disinfection / cleaning cycles of the water
supply system must be carried out. This also applies to the water supply
tubing connected to the haemodialysis device.
In addition, please note the information provided under "External
connection options" (see Chapter 12.9 on page 12-7).

Warning
Only water suitable for dialysis may be used for operating the
haemodialysis device. The quality of the water should comply with the
local regulations (e.g. ISO 13595:2009).
– For information on the water inlet pressure range, the supply

pressure of the dialysate concentrate, temperature, and the flow
rates required for operating the haemodialysis device refer to the
Specifications (see Chapter 12 on page 12-1).
– The national regulations with regard to the prevention of back flow
into the water supply system and the air gap between drain
connection and sewage connection must be observed when
installing and operating the device. For further information refer to
the Specifications (see Chapter 12 on page 12-1).
 Water supply DIASAFE® plus
When using the DIASAFE® plus the following criteria must be observed
with regard to the quality of the process water, concentrate and
dialysate:
Warning
Only reverse osmosis water should be used.
Always ensure that both the process water and the dialysate meet the
applicable standard (see below).
For microbiological quality standards / recommendations refer to the
table below.
General notes The microbiological purity of dialysate prepared in the dialysis centre is
of critical importance.
Process water quality ISO 13595:2009 lists alarm 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) ensure compliance with this standard.
Concentrate quality While acid concentrate may be considered bacteriostatic, bicarbonate

concentrate is an ideal nutrient medium for micro-organisms. The use
of sterile concentrates or of concentrates of low microbiological
contamination is recommended. Online dry concentrates (bibag®)
assist in the preparation of dialysate with high microbiological quality.
The use of concentrate residues from open canisters and the
preparation of bicarbonate concentrate in the dialysis centre 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 high-purity dialysate.
Even when using the DIASAFE® plus, compliance with the
microbiological quality standards is still necessary.
Microbiological quality
standards /
recommendations
ISO 13959:2009 Alarm limit
Maximum allowed Total microbial counts [CFU/ml] Endotoxin concentration [EU/ml]

values for total microbial
count and endotoxin <100 (AL*: 50) <0.25 (AL*: 0.125)
concentration in purified
water (permeate)
ISO 11663:2009 Alarm limits
Maximum permitted Medium Total microbial counts Endotoxin

values for total microbial [CFU/ml] concentration [EU/ml]
count and endotoxin
concentration in Standard dialysate <100 (AL*: 50) <0.5
standard dialysate, High-purity dialysate <0.1 <0.03
high-purity dialysate and
substituate Substituate Sterile Non-pyrogenic (<0.03)
* AL: Action level. ISO 13959:2009: concentration as of which steps should be taken to interrupt the
trend towards higher, unacceptable values. The value usually is about 50% of the alarm limit.
 Functional checks
Prior to each treatment, the prescribed functional checks must be

performed (see Chapter 4.1.10.1 on page 4-32)
9.1.1 Connecting the dialysis device
Initial start-up of the device must be performed by the technical service

support of Fresenius Medical Care or a person authorised by them!
When bringing the dialysis device from a cooler to a warmer room, allow
approx. 2 hours for the device to adjust to the ambient temperature
before switching on the device.
Before initial start-up, the DIP switch settings and the settings in the
SETUP must be checked (see Service Manual).
It is recommended that the responsible organisation check the default
values in the SETUP and adapts them to its requirements if necessary.
The current DIP switch settings must then be entered in the Medical
Device Register.

Warning
Observe the following rules of hygiene when connecting to the water
supply:
– Only use tubes with undamaged packaging.
– Do not open the packaging until shortly before installing the tubing.
– Do not touch the tubing ends and adapter fittings if not absolutely
necessary.
Connect water supply.

The accessories include a fabric-enforced tubing with tube-clips.
The tubing length must not exceed 3 m.
Connect water drain.
The accessories include a fabric-enforced tubing.
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.
Warning
Observe the Specifications when connecting the dialysis device for the
first time (see Chapter 12 on page 12-1).
Turn on the water supply.
Switch-on using the main switch.


Turn on the haemodialysis device!
The On/Off status indicator is illuminated.
Text display
Connect the dialysate tubes to the shunt
interlock, close the shunt interlock.
the rinse chamber.
Place the blue bicarbonate suction tube into
the rinse chamber.
Note
To avoid flow problems during the mandatory rinse (to remove the anti-
freeze), the service switch must be set to ON (up). On completion of the
mandatory rinse, set the service switch back to OFF (down).


Cleaning menu
cleaning program.
Press the Conf key.
The program graphic of the selected cleaning

program is displayed (e.g. Mandatory rinse).
At the end of the rinse program, the program

is automatically terminated.
The Cleaning status indicator is no longer
illuminated.

9.1.2 Inserting / priming the DIASAFE® plus
Warning
Observe the following rules of hygiene when inserting the
DIASAFE® plus:
– Only use filters with undamaged packaging.
– Only remove the packaging and protective straps immediately
before installing the filter.
– Only touch the connectors if required.
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

– Both dialysate tubes are in the shunt interlock.
– The shunt cover is closed.
– The concentrate suction probes must be locked inside the rinse
chamber.
 Operating sequence

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

2 1. Open the locking lever.

2. Slide the adapters up and out of the guide
1 slot.
1
1. Slide the 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 Instructions for
Use.
Warning
Disinfect prior to the first treatment.
Perform the Technical Safety Checks (TSC)

(see Chapter 11 on page 11-1).

Chapter 10: Transport / storage
10 Transport / storage
Warning
Before transporting the device, ensure that there are no caustic or hot
liquids in the device. Programs such as disinfection or hot rinse
(incl. cooling rinse) have to be completed.
Warning
Risk of tilting when pushing the device or leaning against it
Lateral force exerted on the device may result in the device tilting or
slipping. Please observe the specified transport conditions.
10.1 Relocation
In professional health care facilities, the device may be relocated by the

operator inside a building from room to room, on a flat surface and
across thresholds up to 1 cm in height (e.g. elevator thresholds).
In cases when the device is used in a domestic environment, the device
is to be fixed in place.
The device may be relocated only by the manufacturer or persons
authorised by the manufacturer.
Minor displacements are possible, depending on the permitted lengths
of the connection lines.

Relocation requirements:
– Turn the device off.
– Disconnect the power plug.
– Wrap the power cable around the device.
– Disconnect the water supply and the water drain.
– Fix the water supply and water drain tube on the device.
– Disconnect the Central Delivery System (option).
– Place the Central Delivery System tubing on the device (option).
– Remove the concentrate canister(s).
– Remove any objects from the IV pole.
– Completely retract the IV pole.
– Remove the blood pressure cuff holder and the pressure tubing
(option).
– Check that the disinfectant container is firmly secured.
Lift the brake lever.
The haemodialysis device can now be

swivelled, turned or pushed.

Grip the device at the rear and push it with the

front pointing forwards.
10.2 Transport
Relocations beyond the definitions mentioned in chapter 10.1 may only

be performed by the manufacturer or by persons authorised by the
manufacturer. Such relocations are described in the "Service Manual".
The following preparatory steps may already have been performed by
the operator.
– Turn the device off.

– Disconnect the power plug.
– Wrap the power cable around the device.
– Disconnect the water supply and the water drain.
– Fix the water supply and water drain tube on the device.
– Disconnect the Central Delivery System (option).
– Place the Central Delivery System tubing on the device (option).
– Remove the concentrate canister and the disinfectant container.
– Remove any objects from the IV pole.
– Completely retract the IV pole.
– Remove the blood pressure cuff holder and the pressure tubing
(option).

10.3 Storage
10.3.1 Storage conditions
The haemodialysis device must be stored upright in a well-ventilated

room with only slight variations in temperature.
Storage temperature Storage temperature range:
without antifreeze +5 °C to +60 °C

with antifreeze –20 °C to +60 °C
Atmospheric pressure 500 hPa to 1060 hPa
Relative humidity 30% to 75%, temporarily 95%
Antifreeze When storing the haemodialysis device with antifreeze, make sure to
use antifreeze of the following composition:
– 49.875% water
– 49.875% glycerin
– 0.25% ClearSurf
Frost resistance Up to –20 °C
Maintenance of the If the device is not used, the rechargeable batteries must be recharged
integrated rechargeable every six months as follows:
batteries – Connect the device via the power cable to the electricity.
– Then switch on the device for approx. 10 hours.
If the device is not used, repeat this procedure every six months.

10.4 Environmental impact and recycling
This device is manufactured exclusively with recyclable materials.

In EU member states, the device is to be taken back in accordance with
Directive 2002/96/EC (WEEE). Please also observe the applicable local
legal regulations.
The device is generally to be considered as contaminated and the
responsible organisation must therefore ensure that it has been
sufficiently disinfected in accordance with the manufacturer's
instructions.
PCBs can be disposed of in line with electronic scrap regulations.
Non-rechargeable and rechargeable batteries must be disposed of in
line with accepted practice.
Further information on disposal is available on request.
10.4.1 Material list
 Plastics
Description Use in the dialysis

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


circuit
PP-H X
PP(E)
PPO X
PPS X
PPSU X
PS
PSU
PTFE X
PUR
PVC
PVDF X
Silicone SIK X
Silicone tube X
TPE
VMQ SI (Q)
Silicone X
TEEE
CM/ EPDM-L
EPDM
 Metals / glass

circuit
Graphite X
Glass X
Aluminium
Cu sheet
Steel sheet
Al sheet
St37K
1.4300


circuit
1.4301
1.4305
1.4401 X
1.4404/1.4435 X
Spring steel 1.4568
Titanium X
Spring steel 1.4310
 Other – various materials

circuit
Radox
Lexan (acrylic glass)
Oxit 100
Steel 1.1121
Cadmium-plated and chromated steel
MS 58
MS 63
Leather (bag)
Nylon 6/6 UL 94 V-2
Paper
Perlon D536/20 (shutter strap)
Sil-Pad 400
Thermal paste
Synchroflex (toothed belt)
Sirex PU foam (insulation panels),

porous, adhesive on one side
Ceramics X

 Other – adhesives

circuit
Loctite
Scotch-Weld DP 460
Scotch-Weld V 23
Cyanolit
ELASTOSIL
3M Scotch-Weld
EPXDPU60
 Other – paint

circuit
Top coat: Pehapol
Base coat: epoxy resin
Primer:
P 81.914 (base)
Hardener: P 85.033 (PUR)
Insulating varnish: type FS 190
Thinner: type FS 225
Shielding: Elektro DAG 438/

Acheson
 Other – packaging

circuit
Ethafoam (polystyrene)
Corrugated board
Sponge rubber
Wooden pallet

 Electric
Description Assembly type Use in the dialysis

circuit
Copper, cast steel, cast zinc Motors
Copper, polyester / polyurethane, Transformers

PU 151/20 casting compound, UP resin,
iron core
Copper + tin, Plug connectors

glass-fibre reinforced thermoplastic
PCB base material, glass-fibre epoxy, Electronic components

ferrite cores, lithium batteries, rechargeable lead-acid
battery
Copper, PVC, Teflon Cables


Chapter 11: Technical Safety Checks / Maintenance
11 Technical Safety Checks / Maintenance
11.1 Important information for performing TSCs
Checks The Technical Safety Checks must be performed every 24 months.
Qualification requirements Checks must be performed by the technical service support of

of testers Fresenius Medical Care or a person authorised by them.
The checks must only be performed by personnel qualified to perform
the required procedures correctly based on their education, training,
knowledge, and experience. Furthermore, anyone performing the
checks must not be bound by any directives when performing this
activity.
Specifications Please note the information in the specifications.
Documentation Technical Safety Checks, maintenance points and further explanations

on how to perform them can be found in the Service Manual.
Reports can be provided, if requested.
Technical Safety Checks must be recorded in the Medical Device
Register.
Warning
When the device is recommissioned, check that the pressure of the
water supply complies with the prescribed minimum pressure.

Chapter 11: Technical Safety Checks / Maintenance

Chapter 12: Specifications
12 Specifications
12.1 Dimensions and weight
Dimensions Height: approx. 137 cm (approx. 164 cm incl. IV pole)

Width: approx. 50 cm (with shunt interlock)
Depth: approx. 65 cm (approx. 83 cm with extended concentrate rack)
Weight Empty weight including all options: approx. 86 kg

Safe workload: approx. 39 kg
Maximum total weight: approx. 125 kg
12.2 Electrical safety
Classification according to EN 60601-1, IEC 60601-1
Type of protection against Protection class I

electric shock
Applied part Depending on the treatment procedure, the applied part consists of the
extracorporeal blood circuit, the dialysate circuit and all components
permanently connected to the circuit in a conductive manner.
Type of applied part Type B

(degree of patient safety)
Protection against ingress Drip-proof

of liquids
Leakage currents according to EN 60601-1

(IEC 60601-1-2:2014)
Specifications refer to the requirements of IEC 60601-1-2:2014.

12.3.1 Minimum distances between radiation source and medical electrical equipment
Medical electric equipment is subject to special precautions with regard

to electromagnetic compatibility (EMC).
Warning
Patient hazard caused by malfunction of the device
Portable RF communications equipment (radio equipment including its
accessories such as antenna cables and external antennas) should not
be used at a distance less than 30 cm (12 inches) from the device parts
and cables designated by the manufacturer. Failure to observe this
information may have a negative impact on the performance
characteristics of the device.
 In the case of portable RF communications equipment, always
observe a distance of at least 30 cm from the device.
Portable RF communications equipment may include the following

radiation sources (examples):
mobile phone, smartphone, tablet computer, cordless telephone,
notebook/laptop, wireless keyboard, wireless mouse, wireless
speakers, radio remote control (does not apply to the device-specific
radio remote control from the manufacturer)
Warning
The use of electrical accessories and lines other than those specified in
the Instructions for Use can lead to an increase in electromagnetic
emissions or a reduction in electromagnetic immunity of the device.
 Only use accessories and lines approved by the manufacturer.
Warning
Patient hazard due to electromagnetic incompatibility of devices
Electromagnetic radiation from other equipment can cause a
malfunction of the device.
 Do not operate the device in the immediate vicinity of other devices.
If operation near or stacked with other equipment is necessary:
 Monitor the device to verify that it is working properly.

12.3.2 Guidance and manufacturer's declaration on EMC
 Electromagnetic emissions
Guidance and manufacturer's declaration – electromagnetic emissions
The 4008 S device is intended for use in the electromagnetic environment specified below. The customer or the
user of the 4008 S 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 device uses RF energy only for its internal function.
Class B Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Harmonic emissions Class A
IEC 61000-3-2 The 4008 S device is suitable for use in all establishments,
including domestic establishments and those directly
Voltage fluctuations/flicker Complies connected to the public low-voltage power supply network that
emissions IEC 61000-3-3 supplies buildings used for domestic purposes.
 Electromagnetic immunity
Guidance and manufacturer's declaration – electromagnetic immunity
Immunity test IEC 60601 test Compliance level Electromagnetic environment –

level guidance
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, concrete or

discharge (ESD) ±15 kV air ±15 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 or hospital
IEC 61000-4-4 ±1 kV for input / ±1 kV for input / environment.
output lines output lines
Surge ±1 kV line(s) to ±1 kV line(s) to Mains power quality should be that of a

IEC 61000-4-5 line(s) line(s) typical commercial or hospital
±2 kV line(s) to ±2 kV line(s) to environment.
earth earth


level guidance
Voltage dips, short 0 % UT for 0.5 cycle 0 % UT for 0.5 cycle In the event of power supply interruptions,
interruptions and at 0, 45, 90, 135, at 0, 45, 90, 135, the rechargeable battery of the 4008 S
voltage variations 180, 225, 270 and 180, 225, 270 and device temporarily takes over the supply
on power supply 315 degrees 315 degrees for parts of the system without delay.
input lines
0 % UT for 1 cycle 0 % UT for 1 cycle Mains power quality should be that of a
IEC 61000-4-11
typical commercial or hospital
70 % UT for 70 % UT for environment.
25 cycles 25 cycles
0 % UT for 0 % UT for
250 cycles (5 s) 250 cycles (5 s)
Power frequency 30 A/m 30 A/m Power frequency magnetic fields should

(50/60 Hz) magnetic be at levels characteristic of a typical
field IEC 61000-4-8 location in a typical commercial or hospital
environment.
Note: UT is the a.c. mains voltage prior to application of the test level
Conducted RF 3 Vrms 3 Vrms

IEC 61000-4-6 150 kHz to 80 MHz
6 Vrms in ISM bands 6 Vrms in ISM bands

between 150 kHz
and 80 MHz
Radiated RF 10 V/m 10 V/m

IEC 61000-4-3 80 MHz to 2.7 GHz
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
12.4 Electrical supply
Mains voltage 100 V AC, 50–60 Hz, 16 A

(Medical treatments performed at home are not possible with a mains
voltage of 100 V.)
110 V AC, 50–60 Hz, 15 A
120 V AC, 50–60 Hz, 14 A
127 V AC, 50–60 Hz, 14 A
220 V AC, 50–60 Hz, 9 A
230 V AC, 50–60 Hz, 9 A
240 V AC, 50–60 Hz, 9 A
(The decisive criterion is the mains voltage and the operating current
specified on the identification label of the device.)

Power supply (internal) +5 V, +0.3 V, (short-circuit resistant)

+12 V, +0.4 V, (short-circuit resistant)
+24 V, ±0.7 V, (short-circuit resistant)
Rechargeable battery Rechargeable lead-acid battery (maintenance-free)

18 V (= 1 x 12 V + 1 x 6 V) / ≥ 3 Ah
Voltage supply for emitting an audible alarm over at least one minute in
case of a power failure.
Power switch Main power switch, turning off simultaneously on all poles
12.5 Identification label (device identification)
The identification label shown is only an example. Key data is that which
is specified on the identification label of the device.
13 1
12
2
11
10 3
9
7 6 5 4
1 Protection rating IP 21
2: Protection against touch and foreign bodies with a diameter of
at least 12.5 mm
1: Protection against ingress of liquids: drip-proof
2 CE mark
3 Identification of electric and electronic devices
4 Type of applied part (degree of patient safety)
5 Relative humidity (operating conditions)
6 Atmospheric pressure (operating conditions)
7 Operating temperature range
8 Manufacturer with date of manufacture as year digit
9 Power requirements (voltage / operating current)
10 Maximum total weight (empty weight plus safe working load)

11 Equipment Code
12 Serial number
13 Type identification
12.6 Fuses
Rechargeable battery 1 x T 3.15 AL, power supply unit, fuse in housing foot (rear) / SI5
12.7 Operating conditions
Water supply pressure 1.5 to 6.0 bar
Water supply temperature 5 °C to 30 °C

during "integrated hot rinse": 85 °C to 95 °C
Water supply flow rate 1.3 l/min; with 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
lower than the position of the dialyser.
Temperature at the water Maximum temperature at the water drain: 95 °C

drain
Concentrate supply 0 to –100 mbar; maximum suction height 1 m, max. height of fall 0 m
Central Delivery System Pressure: 0 to 500 mbar

Temperature: 15–35 °C
Flow: max. 30 ml/min
Operating temperature 15 °C to 35 °C
range
Atmospheric pressure 700 hPa to 1060 hPa
Relative humidity 30% to 75%, temporarily 95%
IV pole load capacity Maximum 5 kg
Temporary removal from Prior to temporarily removing the device form service, it is
service recommended to carry out a hot rinse program without a cooling rinse
(PGM 2) and a disinfection prior to recommissioning the device.

12.8 Consumption data / energy data
The consumption data / energy data are examples of average values for
typical operation.
Ambient conditions: water inlet temperature 15 °C, ambient
temperature 22 °C.
The average consumption is based on a dialysis treatment with a blood
pump rate of 350 ml/min and a dialysate flow of 500 ml/min.
Unless otherwise stated, the following consumption values are
determined for one operating hour.
The data for the cleaning programs is based on the factory settings and
apply to each program.
Other data is available from the manufacturer on request.
Mean water consumption Dialysis: approx. 30 litres

Disinfection / hot disinfection: approx. 9 litres
Mean acid concentrate Dialysis (dilution 1+44 ACF): approx. 0.7 litres
consumption
Mean bicarbonate approx. 650 g bicarbonate (bibag®) every 4 hours

consumption
Mean energy consumption Dialysis: approx. 0.67 kWh

Hot disinfection: approx. 0.79 kWh
Mean energy emission to Dialysis: approx. 0.50 kWh

the drain Hot disinfection: approx. 0.46 kWh
Mean energy emission into Dialysis: approx. 0.17 kWh

the environment Hot disinfection: approx. 0.33 kWh
12.9 External connection options
Warning
Other, additional equipment connected to this device must comply with

the valid IEC or ISO standards (e.g. IEC 60950-1 for information
technology equipment).
Furthermore, all device configurations must comply with the normative
requirements for medical electrical systems (see Chapter 16 and
Appendix I to EN 60601-1:2006).

Potential equalisation Maximum length 4 metres, unshielded

cable
Service measuring devices Connection jack for service measuring devices

(4) (service measuring devices may not be used during treatment).
Length of serial cable: max. 3 m, shielded.
Service PC (5) Only used for the connection of a service PC (may not be used during
treatment).
Length of serial cable: max. 3 m, shielded.
Alarm in Used to connect an external Fresenius patient alarm or the AquaUNO /

(alarm input) (6) AquaC UNO H. These devices can be used to trigger a device stop.
Length of control cables: 3 m or 11 m
Alarm out This can be used for the connection of an external alarm indicator
(alarm output) (7) (staff call). (Potential-free alarm output, changeover contact maximum
24 V / 24 W.)
Connection jack: 5-pin diode plug via a shielded line; shield earthed on
either side.
Only the cable from the manufacturer-approved accessories may be
used.
Length: max. 3 m, unshielded
Remote control (10) Remote control port (option)
Network (15) LAN (Local Area Network) network connection (option)

Connecting the device to an IT network that contains components not
installed and validated by the manufacturer can introduce unknown
risks for patients, operators or third parties. These risks must be
identified, analysed, evaluated and checked by the responsible
organisation. For assistance, consult IEC 80001-1:2010 and
annexes H5 and H6 to EN 60601-1:2006.
Any modification to an IT network that has been installed and validated
by the device manufacturer can introduce new risks and therefore
requires a repeat analysis. Especially problematic activities:
– changes to the IT network configuration
– connection of additional components and devices to the IT network
– removal of components and devices from the IT network
– updating or upgrading components and devices in the IT network
Attention is drawn to the fact that local laws take priority over the above-
mentioned normative requirements. If in doubt, consult the local service
support.
The responsible organisation has to ensure that the device is protected
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 configurer is responsible for secure further processing of
data, e.g. in PC software applications.
The network operator is responsible for protecting data which is
transferred unencrypted.

The data transfer of alarm states via the network must not be used for
the purpose of external alerts.
Shielding: CAT5 or higher
Length: 4 m
12.10 Override conditions
Audio paused Audible alarm mute time: adjustable in the SETUP from 1 to 2 minutes
(factory setting: 1 minute).
A new alarm activates the muted audible alarm.
Overriding a blood leak Override time: 2 minutes.
Overriding the alarm Use the Start/Reset key to suppress:

– the arterial and venous pressure alarm for approx. 8 seconds
– the blood leak alarm for approx. 8 seconds
– the TMP alarm for approx. 2 minutes (time depends on the
UF coefficient)
When overriding a safety system the responsibility for the patient’s
safety rests with the operator of the device.
12.11 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 power on (not following a power failure)
Preparation Defined by the optical detector below the venous bubble catcher.
The preparation phase is automatically terminated when blood is
detected in the tubing system by the optical detector.
Priming the tubing system Automatic priming of the tubing system after pressing the key
(Preparation).
Priming is automatically terminated as soon as the venous bubble
catcher is filled, which should be no longer than 1 to 5 minutes (time
adjustable in the SETUP menu).
Dialysis Acetate dialysis or bicarbonate dialysis

Display of the dialysis duration
Maximum time: 9:59 hours
Resolution: 1 minute
Accuracy*: maximum ±0.6 seconds per hour
Sequential ultrafiltration Ultrafiltration without dialysate flow / ISO-UF (Bergström method)

Single-Needle Click-Clack Using both the arterial blood pump and venous occlusion clamp;
dialysis pressure-pressure controlled with adjustable pressure switching
values. Exceptional procedure in cases for example, with the vascular
access during Double-Needle dialysis.
Single-Needle dialysis Two-pump procedure with adjustable upper pressure switching values
(option) (adjustable via stroke volume).
Cleaning programs Rinse and chemical disinfection:

Time adjustable in the SETUP, temperature: approx. 37 °C, flow: 600 or
800 ml/min (can be set via the DIP switch)
Hot rinse / hot disinfection / integrated hot rinse:
Time adjustable in the SETUP, temperature: approx. 84 °C, flow:
450 ml/min
Time stops in the event of a lower temperature alarm.
In all cleaning programs:
The blood pump(s) stop(s), the venous occlusion clamp is closed.
The active program (time counting) is interrupted in case of a flow
alarm.
The cleaning programs can be stopped.
The chemical disinfection program is followed by a mandatory rinse.
(* essential performance characteristics for IEC 60601-1)
12.12 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 to 800 ml/min)
When the dialysate flow is turned off, a blood leak alarm response is
delayed. The delayed response depends on the fluid volume in the rinse
section between the dialyser and blood leak detector (approx. 110 ml
total fluid volume) and on the size of the membrane rupture in the
dialyser. The response of the blood leak alarm is also dependent upon
the set ultrafiltration rate.
Transmembrane pressure Display range: –60 to 520 mmHg

Resolution: 20 mmHg
– The OD in the level detector does not sense blood: alarm window
width: wide window, top and bottom LEDs
– The OD in the level detector senses blood: alarm window width:
dependent on the UF coefficient
During dialysis the TMP will increase 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 drift upwards to a maximum of 120 mmHg.
SN-Click-Clack: alarm limits extended by ±10 mmHg

TMP measuring equipment with adjustable alarm limits.

Definition TMP = Pbo – Pdo + Offset
TMP = transmembrane pressure
Pbo = blood pressure on the outlet side of the dialyser
Pdo = dialysate pressure on the outlet side of the dialyser
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 accuracy: ±1%
Maximum rate internally adjustable to 1, 2, 3 or 4 l/h
Safe condition: pressure equalisation via the dialyser membrane,
ultrafiltration = 0
Cyclic pressure holding V24 and V24b closed; bypass operation

test
Activated every 12.5 minutes on the outlet side of the dialyser.
Balancing* Accuracy:
±0.1% related to the total dialysate volume
Maximum balancing error F = FUF + FBil

F= maximum balancing error
FUF = Ultrafiltration error
FBil = Balancing error
Example:
Ultrafiltration error: for 1000 ml in 1 hour: ±1% = ±10 ml/h
Balancing error: for a total dialysate flow of 30 l in 1 hour and for 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 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 blood or if no blood is sensed by the OD and with the
dialyser couplings attached to the dialyser:
0.8 mS/cm (< ±5% around the actual value)
– If no blood is sensed by the OD and the dialyser couplings are in the
shunt interlock:
top and bottom LEDs set
Alarm window position:
Lower limit: 12.8 to 14.0 mS/cm (adjustable in SETUP)
Upper limit: 15.7 mS/cm (fixed setting)

Temperature-compensated electronic conductivity meter with

adjustable alarm limits.
Volumetric proportional mixing system. The desired concentration is
achieved within 10 minutes.
– Acetate:
Standard setting 1+34
Adjustment range: 125 to 150 mmol/l, depending on the concentrate
used.
– Bicarbonate and acid:
Standard setting 1+34
(Other dilutions can be set in the SETUP.)
Adjustment range: 125 to 150 mmol/l, depending on the concentrate
used.
Bicarbonate adjustment range: ±8 mmol/l
– bibag® :
Bicarbonate concentrate preparation from the bibag®
Dialysate temperature* – Selectable range:

Desired temperature 35.0 °C to 39.0 °C,
adjustable in increments of 0.5 °C
Measuring accuracy: ±0.5 °C
Alarm limits: 33.0 °C and 40.0 °C
Temperature measuring equipment independent of regulation and
provided with alarm limits.
Depending on the ambient conditions and the selected dialysate
flow, the dialysate temperature on the dialyser can deviate from the
desired temperature by up to +1.0 °C / –2.0 °C.
Rinse and chemical – Cleaning programs: 37 °C

disinfection temperature Display range (text display): 33 °C to 41 °C
Resolution: 1 °C
Measuring accuracy: ±0.5 °C
Hot rinse and chemical hot – Hot rinse and chemical hot disinfection temperature: 84 °C
disinfection temperature Display range (text display): 72 °C to 99 °C
Resolution: 1 °C
Accuracy: ±2 °C
Flow* – Dialysate flow:

Desired values: 300, 500, 800 ml/min.
If AdaptedFlow is activated in the SETUP:
Dialysate flow = effective blood flow x AdaptedFlow factor, rounded
up to the next 100
Factor: 1.2 or 1.5 times the effective blood flow or "variable" from
1.0 to 2.0 in increments of 0.1 (adjustable in the SETUP)
Accuracy:
Flow: ±10%
Measurement by means of time pulse monitoring
– Rinse and disinfection flow:
Desired value: 800 ml/min (600 ml/min, adjustable via DIP switch)
– Hot rinse flow:
Desired value: 450 ml/min
– Flow alarm:
Value is more than 20% below desired value.

– In case of water shortage:

Visual alarm, heater turned off,
only if the OD in the level detector senses blood: audible alarm
DIASAFE® plus Filter life time: maximum of 12 weeks or 11 degreasing programs.

The filter service life is monitored by the dialysis device and a warning
(filter change) is displayed.
OCM function Clearance

Measuring accuracy: ±6% standard deviation
Shortest measurement interval: 25 minutes
Warning
The measurement data for the conductivity measurement section
(CD cell before or after the dialyser) serve to evaluate and calculate the
clearance, Kt/V and Plasma Na+ parameters and are not
safety-relevant.
12.13 Extracorporeal blood circuit and safety systems
 Arterial range
Arterial pressure Display range: –300 to +280 mmHg

measurement Resolution: 20 mmHg
Accuracy: ±10 mmHg
No blood sensed by the OD in the level detector:
Alarm window width: –300 to +280 mmHg
The OD in the level detector senses blood:
Alarm window width: 120 mmHg,
adjustable over the entire display range
For Single-Needle dialysis as well as for Single-Needle Click-Clack
dialysis:
The OD in the level detector senses either blood or no blood; upper
alarm 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 ml/min
Line diameter: 2 to 10 mm
Resolution: 0.2 mm
Blood pump stop alarm: 15, 30 seconds
(factory setting: 30 seconds)

Fully occluding spring loaded rollers, pressure-limited to 2.7 bar

(when using the permitted tubing systems).
The direction of rotation of the blood pump is monitored.
Depending on the construction, the rotor of the blood pump can only to
be turned manually in a clockwise direction.
Effective blood flow* Display range: 0 to 600 ml/min

Resolution: 1 ml/min
Accuracy: ±10 %
Effective blood flow can only be determined correctly if the arterial
pressure line is connected during treatment.
System accuracy for the delivered blood volume: ±10 % over the entire
duration of the treatment, for typical treatment situations.
If the arterial pressure line is not connected, deviations of more than
±10 % are possible.
Warning
Risk for the patient as a result of insufficient detoxification
If the arterial pressure before the blood pump suffers excessive
negative values, then this may reduce the blood flow and, in turn,
treatment efficacy.
 Take suitable measures to prevent extreme negative arterial
pressures at the access.
Blood pump (SN) (option) Stroke volume: 10 to 50 ml (factory setting 30 ml)

Resolution: 5 ml
Same specifications as for the arterial blood pump
Pressure transducer for Single-Needle: pressure switchover
Heparin pump Delivery rate: 0.1 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 Fresenius heparin syringe (part number
F00001255)
With delivery rates <1.0 ml/h, the tolerance may exceed the specified
±5% accuracy.
Stop time: 0 minutes up to 2 hours
Resolution: 1 minute
Bolus administration: 0.1 to 5.0 ml
Resolution: 0.1 ml
Maximum cumulated bolus administration: 1 x syringe contents

 Venous range
Venous pressure Display range: -60 to +520 mmHg

measurement Resolution: 20 mmHg
Accuracy: ±10 mmHg
No blood sensed by the OD in the level detector:
Alarm window width: –60 to +520 mmHg
The OD in the level detector senses blood:
Alarm window width: 40 to 200 mmHg
(Default value: 120 mmHg),
adjustable within a range of 20 to 520 mmHg
(Advanced adjustment option over the entire display range if ven.
window pos: ON is activated in the SETUP and in the treatment mode
menu it was set to –60 mmHg for the current treatment)
With Single-Needle Click-Clack dialysis:
Alarm window width:
80 to 460 mmHg, adjustable from 20 to 480 mmHg
Monitoring of the venous return pressure.
Level detector Response threshold: a drop in the fluid level, air bubbles, foam or micro
bubbles (blood/air mixture) over the entire blood flow range from 0 up to
600 ml/min.
An alarm is triggered at 5 ml of air in a volume flow of 600 ml/min.
The air volume is based on the level of micro bubbles with a bubble
diameter < 10 µm when the tubing systems suitable for the machine are
used.
Method: ultrasound transmission
 Audible alarm
Adjustment range for the audible alarm's sound pressure level:

Adjustable with the volume control on the rear of the monitor,
Volume range: 55 to 70 dBA (±10%)
Factory setting: ≥65 dBA


Chapter 13: Definitions
13 Definitions
13.1 Definitions and terms
Terms used in these Instructions for Use are explained below.
Arterial pressure Pressure in the extracorporeal circuit between the arterial cannula and
the blood pump.
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.
Bubble catcher Chamber integrated in the tubing system for the separation of gases
which are not dissolved in the blood.
Bypass Process during which the dialysate is diverted away from the dialyser.
Compliance chamber Receptacle for controlling the levelling variations in pressure and
volume, e.g. in Single-Needle dialysis.
Conductivity A measured specific electrical resistance, e.g. of the dialysate.
Dialysate The replacement fluid used in haemodialysis.
Dialysate pressure The pressure present in a defined section of the dialysate pathway,
e.g. at the dialyser outlet.
Dialyser blood connection Arterial or venous blood connection port positioned on the dialyser.
Extracorporeal circuit An external circuit containing blood outside the body.
Occlusion clamp Device for automatic clamping of the tubing system, e.g. in the event of
alarms or in Single-Needle operation.
PatientCard Formatted patient card
Pressure measurement Tube connecting the tubing system with the pressure monitoring unit.
line
Pressure measurement Connector for the pressure measurement line, e.g. Luer-Lock.
port
Process water Water suitable for dialysis (e.g. water purified by reverse osmosis).

Pump head The pump head comprises of a pump rotor and pump stator.
Pump rotor Driven part of the pump head.
Pump segment Tube segment which is inserted into the pump head.
Pump segment holder A holder for fixing the blood pump segment.
Pump stator A fixed support for the pressure pulleys of the pump rotor.
Sequential therapy The haemodialysis treatment is divided into two successive treatment
(ISO-UF) phases during which either only ultrafiltration or diffusion and
ultrafiltration are performed (Bergström method).
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 dialyser 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 mode), temperature (bypass mode), flow.
13.2 Abbreviations
AC Alternating current
BC Balancing chamber
BIC Bicarbonate
BP Blood pump
CD Conductivity
CDS Central Delivery System
DC Direct current
Fig. Figure (diagram)
HD Haemodialysis
HDF Haemodiafiltration
LAN Local Area Network (network connection) (option)
LD Level detector
LED Light-emitting diode

OCM Online Clearance Monitoring
OD Optical detector
SI Shunt interlock
SN Single-Needle
SV Solenoid valve
TDMS Therapy Data Management System
TMP Transmembrane pressure
TSC Technical Safety Checks
UF Ultrafiltration
13.3 Symbols
The following symbols for identification on the device and / or on the

identification label are necessary due to legal / normative requirements:
Follow Instructions for Use
General warning sign Only permitted accessories may be used.
Warning; Excessive weight load (respect the maximum load)
Warning; Risk of tilting when pushing the device or leaning against it
Warning; Hot surface

IP21 IP RATING 21
– (2) Protection against touch and foreign bodies with a diameter of at
least 12.5 mm
– (1) Protection against ingress of liquids: drip-proof
Identification of electrical and electronic devices
Degree of protection against electric shock:

Type B
Limitation of the relative humidity (operating conditions)
Limitation of the atmospheric pressure (operating conditions)
Temperature limitation (operating conditions)
Manufacturer together with the year of manufacture

YYYY
Maximum total weight
Serial number
Power switch – ON / OFF

I/O
ON / OFF (device)
Audio paused
Degree of protection against electric shock:

Defibrillator-protected applied part of type CF
Alternating current
Protective earth connector
Earth / operational earth
Equipotential bonding port
Dangerous electrical voltage

Disconnect the power plug before opening
IN max. IN:
6 bar
Water supply (permeate), inlet (6 bar max.)
OUT:
OUT Drain (water)
CDS:
CDS max.
500 mbar
Central Delivery System (500 mbar max.)
Disinfectant connector
Disinfectant Disinfectant:
Disinfection solution
Fuse T 3,15 AL, 250 V
Fuse T 3,15 AL, 250 V Battery (PB)
Accumulator (PB)
18 V / ≥3 Ah
18 V / ≥3 Ah
TO -
TO – Dialyser:
To dialyser
Dialyser
FROM – Dialyser:
FROM - From dialyser
Dialysate tube holder
Service switch
organisation.
Audible alarm volume control
Connection jack for service measuring devices

(service measuring devices may not be used during treatment).
Connection jack PC
Only used for the connection of a service PC (may not be used during
treatment).
Connection jack ALARM IN

Used to connect an external Fresenius patient button or an AquaUNO /
AquaC UNO H. These devices can be used to trigger a device stop.
Connection jack ALARM OUT

Can be used to connect an external alarm indicator (staff call).
LAN (Local Area Network) network connection (option)

Hour meter
Remote control port (option)
Caution: Consult accompanying documents.

General warning sign Only permitted accessories may be used.
max. 5 kg Warning; Excessive weight load (respect the maximum load)
Warning; Risk of tilting when pushing the device or leaning against it

Reduced braking effect when inclined by more than 5°
Warning; Hot surface
IPX1 IP type of protection X1

– (1) Protection against ingress of liquids: drip-proof
Nr. / No.: Serial number
13.4 Symbols for consumables (extract)
Do not re-use
2
Use by date
Batch code
LOT
Date of manufacture
Quantity
Catalogue number
REF
+30°C
Temperature limitation
+5°C

Pump segment diameter
Sterile. Sterilised using ethylene oxide

STERILE EO
Sterile. Sterilised using irradiation

STERILE R
Sterile. Sterilised using steam or dry heat

STERILE
13.5 Bibliography
On dialysis in general – Franz, H.E.: "Blutreinigungsverfahren" Technik und Klinik;

Hämodialyse, Peritonealdialyse, CAPD, Hämofiltration,
Hämodiafiltration, Hämoperfusion, Membranplasmaseparation; 2nd
revised edition / 1991 Georg Thieme Verlag Stuttgart, New York; 1st
edition 1973 entitled: "Praxis der Dialysebehandlung"; ISBN 3 13
497702 8.
Dialysate filter system Publications, research reports on polysulphone membrane, with the
following references:
– "No evidence for endotoxin transfer across high flux polysulfone
membranes"; by, among others, Professor Dr. med. Jürgen Bommer
of the Ludolf-Krehl-Klinik in Heidelberg, Germany.
– "Filtration of dialysate using an ON-LINE dialysate filter"; from 05
June 1990; by, among others, 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 high-flux polysulphone with references.
– "Hemodiafiltration with ON-LINE Production of Bicarbonate Infusate:
a new standard for high efficiency, low-cost dialysis in elderly and
uncompliant patients"; by, among others, 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.

13.6 Certificates
13.6.1 EC certificate






Chapter 14: Options
14 Options
14.1 Single-Needle dialysis
Warning
hydrophobic filters on the pressure lines. If a hydrophobic filter has
become wet, the tubing system must be replaced.
pressure measurement line can 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 on 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!

Chapter 14: Options
14.1.1.1 Setting the stroke volume when using a Single-Needle blood pump
Rate: ml/h (Ø:ml) Simultaneously press the  key and the

Start/Stop key on the Single-Needle blood
Start pump key pad.
Stop
The stroke volume is displayed in ml.
Rate: ml/h (Ø:ml) Use the  key or the  key to set the desired
stroke volume.
Start
Adjustment 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 blood pump 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
dark.
The arterial blood pump stops.
Connection with volume bolus:

Connect the arterial and venous tubing
system to the patient.
Connection without volume bolus:
patient.

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 tubing system 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 status indicator is illuminated.

Chapter 14: Options
Rate: ml/h (Ø:ml) Press the Start/Stop key on the arterial blood
pump.
Start
Stop The Operation (green) status indicator of the
blood pump is illuminated.
The blood pumps will rotate (provided
there is no blood alarm)
The optical detector senses blood.

(warning / info).
Text display
Preparation end
The alarm limits (arterial, venous, TMP and
conductivity) are set automatically.
The venous tube clamp closes.
Audible signal

flashing.
patient (unless this has already been done).
Check the level in the venous bubble catcher

and adjust, as necessary.
Only possible when the Single-Needle
blood pump is rotating.

Chapter 14: Options

illuminated.
The blood pumps are started automatically.
SN Dialysis
Text display
Note
When performing Single-Needle dialysis, it is important to perform the
treatment with the maximum blood flow.
14.1.1.3 End of treatment

(warning / info).
UF goal reached
Text display, e.g. UF goal reached
Rate: ml/h (Ø:ml) Stop either the arterial or the Single-Needle

blood pump.
Start
Stop

Chapter 14: Options
1. Open the cover.

2/4
the rotor stops.
3. Remove the tube segment on the left.
1/6 4. Press and hold the Start/Stop key until

the tubing system has been completely
removed.
5. Remove the tube segment on the right.
6. Close the cover.
3
5
Press the SN key.

The SN status indicator is no longer
illuminated.
If required, further information is available regarding the expected return

blood flows during the Single-Needle treatments, provided the
recommended blood lines, dialysers, fistula needles or catheters have
been used.

Chapter 14: Options
14.2 Option BPM (Blood Pressure Monitoring)
14.2.1 To be observed before using the BPM option
The decision whether to use the BPM is the responsibility of the

attending physician.
Warning
General warning sign
The sign shown at the BPM port of the device means:

No accessories other than the approved ones (insulated pressure
tubing and insulated cuffs) should be used (see Chapter 8.3 on
page 8-8).
Warning
Under no circumstances should the device be used as a substitute for
regular monitoring of the patient by the clinic staff.
Warning
The BPM may not be used to carry out measurements on neonates or
infants.
The decision to use BPM during pregnancies with pre-eclampsia is the
responsibility of the attending physician.
Warning
Risk to patient due to incorrect data
Inflating the blood pressure cuff can cause a monitoring device
(e.g. pulse oximeter) attached to the same limb to produce an incorrect
measurement.
 Attach the blood pressure cuff to limbs where no other monitoring
devices are attached.
Warning
The list below shows examples of generally valid contra-indications:
– Using a heart / lung machine
– Complications in the peripheral circuit
– Convulsions
– Spasms
– Tremors
– Tachycardia
– Arrhythmia

Chapter 14: Options
Warning
Quality of measurement results:
In order to obtain the best measurement results, it is necessary to
choose the correct blood pressure cuff for each use.
Do not attach the cuff over thick or heavy clothing, since this could
invalidate measurement results. Rolled-up sleeves can influence
measurement results.
Blood pressure measurement results are influenced by the
measurement point and the patient’s position (sitting, supine), level of
physical exertion and physiological condition.
To ensure a correct measurement can be taken, the patient’s position
should always be the same and the cuff should be centred at the height
of the right atrium.
During a BPM measurement, the patient should as far as possible be
relaxed and should not speak during the measurement procedure.

Chapter 14: Options
14.2.2 BPM menu overview
5 2
1 Status indicator bottom field 4 Settings

Blue: last measured value Presel. pressure (inflation 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 alarm limits of the systolic, 5 Monitor
diastolic, mean arterial pressure and pulse. SYS (systolic pressure)
DIA (diastolic pressure)
3 Quick (short interval measurement)
MAP (mean arterial pressure)
Successive measurements within a measuring
PULSE (heart rate)
time of approx. 5 minutes
Displays the actual values.
OFF: Quick mode off
As long as no valid measurement result exists,
START: Quick mode can be started
three lines are shown in place of each value.
ACTIVE: Quick mode on
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 accessed.

Chapter 14: Options
With the arrow keys, the individual fields in

the menu can be selected.
The values are entered with the 0–9 keys or
+/– keys.
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 Alarm reactions for physiological alarms (SYS, DIA, MAP, and pulse)

(warning).
Acute alarm system:
(alarm).
Warning
BPM: Measurement value
outside the alarm limits Message: Warning
Alarm
Acute alarm system:
BPM: Measurement value
outside the alarm limits Message: Alarm

flashing.
In addition, during treatment:

Audible signal

Chapter 14: Options
Any values determined that deviate from the

preset values are displayed in yellow on the
monitor.
14.2.4 Applying the blood pressure cuff
Warning
The blood pressure cuff may not be attached as follows:
– To limbs where a vascular access (e.g. shunt) is present.
– To the arm on the side where a mastectomy has been performed.
– Over any wound or puncture site, since this can lead to additional
patient injury.
Warning
When attaching the blood pressure cuff, the following precautions must
be respected:
To ensure that the blood pressure cuff does not move during the
measurement it must be positioned and connected correctly.

Chapter 14: Options
Place the blood pressure cuff firmly and

correctly around the selected limb, e.g. the
upper arm. Observe illustrations "a" and "b".
The blood pressure cuff must be close-fitting
and in contact with the skin at all times. The
marking must be located directly above the
artery.
14.2.5 Checking / setting the inflation pressure / alarm limits
When setting the inflation pressure, make sure that it is not set
unnecessarily 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 inflation pressure of the BPM will be
automatically calculated by the BPM from the last systolic pressure.
At any time the operator can manually adjust the inflation pressure.
In the BPM menu
Check the alarm limits of SYS, DIA, MAP, PULSE.
Set the desired parameters when required. Press the Conf key to
confirm the values entered.
Visually check the confirmed values.
14.2.6 Starting the blood pressure measurement
Warning
The pressure tube must not be kinked or squeezed.
While using the BPM, it is important to check 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 repeatedly using the
automatic short-term operation (Quick).

Chapter 14: Options
Note
During the measurement, the patient should not be left unattended.
In the case of alarm situations or unexpected measurement results, first
check the patient’s condition, the patient’s arm, the blood pressure cuff
and the pressure tube.
If in any doubt whatsoever, switch off the BPM immediately.
The following applies to all measurements:

The maximum duration of a measurement is 3 minutes.
A measurement is repeated no more than 3 times.
14.2.6.1 Single measurement
Press the BPM Start/Stop key.

Status indicator green; shows the
current cuff pressure.
14.2.6.2 Interval (long interval measurement)
Press the BPM Menu key.

Use the arrow keys to select the Interval
field.
Use the +/– keys to select the desired time
interval and confirm using the Conf key.
(5, 10, 15, 30, 45, and 60 min)

Chapter 14: Options
Use the BPM Start/Stop key to start the first

measurement.
Status indicator during the
measurement:
Green
Status indicator after the

measurement:
Yellow: The systolic and diastolic
pressures from the previous
measurement are displayed. No
measurement is being performed.
Note
An interval measurement in progress will automatically be deactivated
by the start of a cleaning program.
Note
An ongoing measurement in interval mode can be stopped by pressing
the BPM Start/Stop key. This, however, does not stop 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.
 Deactivating the interval

Use the arrow keys to select the Interval
field.
Select OFF using the +/– keys and confirm
using the Conf key.

Chapter 14: Options
14.2.6.3 Quick (short interval measurement)

Use the arrow keys to select the Quick field.
Use the +/– keys to select the START
position.
Use the Conf key to start the Quick mode.
During the measurement:
The status indicator is green during the
measurement.
The BPM menu remains displayed.
The alarm limits are grey and inactive.
Quick is displayed in the ACTIVE field.
After the measurement:

The status indicator is blue after the
measurement.
The systolic and diastolic pressures from
the previous measurement are
displayed.
Quick is displayed in the OFF field.
Maximum runtime: 5 minutes
Note
The Quick mode when in progress can be stopped by pressing the
BPM Start/Stop key.
14.2.7 Terminating / stopping the blood pressure measurement
Warning
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
pressure port on the BPM.
Warning
Check the measurement results to verify they are plausible and
correctly assigned to the patient.

Chapter 14: Options
Press the BPM Start/Stop key.

Status indicator blue, the systolic and
diastolic pressures from the last
measurement are displayed.
14.2.8 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 (syst / diast)
The following is shown:

– Systolic pressure (syst.) in mmHg (shown in red with an X)
– Diastolic pressure (diast.) in mmHg (shown in blue with a plus sign)
– Pulse per minute (1/min shown in black with a circle)
 BPM data (MAP)

Chapter 14: Options

– Mean arterial pressure (MAP) in mmHg (shown in red with an X)
– Pulse per minute (1/min shown in black with a circle)
 BPM History
Time Pulse

– Time of the measurement
– 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 the bottom of the list. If only one
diagram is chosen from the Dialysis representation menu, the history
display is twice the height.
14.2.9 Specifications / general notes
BPM was clinically validated in accordance with the regulations in

ISO 81060-2:2013.

Chapter 14: Options
1 Blood pressure cuff

2 Blood pressure cuff holder
1
3 BPM pressure connection
2 4 Pressure tube
Only valid for the BPM Defibrillator-protected applied part of type CF

blood pressure cuff:
Degree of protection
against electric shock
Blood pressure Cuff pressure measuring range:

10 mmHg to 280 mmHg
Display range:
– Systolic pressure: 30 mmHg to 280 mmHg
– Diastolic pressure: 10 mmHg to 240 mmHg
– MAP: 20 mmHg to 255 mmHg
Resolution: 1 mmHg
Preselected pressure: 100 to 290 mmHg
Accuracy of the blood Maximum systematic measurement deviations:

pressure measurement Systolic blood pressure: –0.9 mmHg
Diastolic blood pressure: –3.2 mmHg
Standard deviation according to clinical check:
Systolic blood pressure: 6.4 mmHg
Diastolic blood pressure: 7.1 mmHg
BHS grading:
systolic: A
diastolic: B
Maximum measurement deviation of the cuff pressure: ±3 mmHg
Pulse Display range: 20 to 245 1/min

Resolution: 1/min

Chapter 14: Options
14.2.10 Description of the BPM
 Functional principle
The module functions according to the oscillometric principle. The blood

pressure cuff is inflated with an electric pump. The pressure in the blood
pressure cuff is then gradually reduced via the drain valve. The
pulse-induced pressure changes in the blood pressure cuff are added
to the pressure generated by the pump and controlled by the drain
valve.
The BPM control limits the maximum pressure in the blood pressure cuff
to 300 mmHg. An additional monitoring device ensures an immediate
pressure release 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, Dialysis and Reinfusion. Up to 60 values can be
displayed as graphics. The last 19 values can be displayed as a
protocol.
It is not possible to carry out measurements during a filter change
(DIASAFE® plus).
It is possible to use the BPM simultaneously with a defibrillator
(defibrillator-protected applied part of the type CF). 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 performs a single blood pressure measurement. If the
blood pressure parameters could not be determined, the process is
automatically repeated, or an error message appears (see
Interval (long 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 window.
Quick (short interval The Quick mode is used under extraordinary circumstances, where a
measurement) continuous blood pressure measurement is required. The decision to
activate the Quick mode should only be taken by qualified staff, as the
process places continuous stress 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.

Chapter 14: Options
The first measurement in Quick mode corresponds to a single

measurement in the manual mode. Subsequently, quick measurements
are carried out one after the other and as fast as possible. During this
mode, 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.
Quick mode can always be stopped using BPM Start/Stop. The
ongoing blood pressure measurement will then be interrupted
immediately.
It is then possible to switch to other operating modes.
14.2.11 BPM error messages
Message / code Cause Possible solution
F# BPM error System error. Dialysis can be If the error recurs, call service support.
( Remove the cuff from continued without further blood
the patient! ) pressure measurements.
BPM: Measurement value Blood pressure cuff not correctly Check the blood pressure cuff
outside the alarm limits connected. Leakage in the pressure connection.
tubing. Alarm limits not adjusted for the Check that the pressure tubing is not
patient. damaged or kinked.
Adjust alarm limits if necessary.
BPM: Cuff cannot be Blood pressure cuff not correctly Check the blood pressure cuff
inflated connected. Leakage in the pressure connection.
tubing. Check that the pressure tubing is not
damaged or kinked.
BPM: Inflation time limit Leakage in the pressure tubing. Check that the pressure tubing 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 tubing was kinked during the Check that the pressure tubing is not
measurement. damaged or kinked.
BPM: Measuring time No valid measurement within the Start a new measurement after
limit exceeded allowed max. measurement time. allowing sufficient time for the blood to
flow back.
BPM: Maximum cuff Pressure tubing was kinked during Check that the pressure tubing is not
pressure exceeded inflation. damaged or kinked.
Cuff was squeezed after inflation. Check the blood pressure cuff position.
If the error recurs, call service support.
BPM: Inflation pressure Wrong blood pressure cuff was used. Check that the blood pressure cuff is
reached too quickly Pressure tubing clogged or kinked. suitable. Wrong blood pressure cuff
was used.
Check that the pressure tubing is not
obstructed, damaged or kinked.

Chapter 14: Options
Message / code Cause Possible solution
BPM: Cuff pressure Pressure tubing was kinked during Check the blood pressure cuff position.
higher than preselected inflation. Check that the pressure tubing is not
pressure Blood pressure cuff was squeezed after damaged or kinked.
inflation.
If the error recurs, call service support.
BPM: Measurement not It was not possible to determine a Check the blood pressure cuff position.
successful measurement value.
BPM: Option not BPM option not installed. If the BPM option is installed:
available Due to the F# BPM error error the BPM If the error recurs, call service support.
option is no longer available during the
current treatment.

Chapter 14: Options
14.3 Data transfer of treatment parameters

(download and upload) (option)
14.3.1 Important notes
Warning
The treatment parameters received by the haemodialysis device via the
network must be checked by the operator for plausibility and
must comply with the physician's prescription prior to being applied.
Only after this check the data may be confirmed using the Conf key.
Warning
Treatment using incorrect treatment parameters
If the assignment of the PatientCard to the patient is not unique,
incorrect treatment parameters (i.e. for a different patient) could be
loaded into the haemodialysis device.
– Ensure the PatientCard is labelled with the complete name of the
patient before the treatment.
– Depending on the settings in the Setup ensure that the patient's ID
and date of birth are written on the PatientCard.
– Before inserting the PatientCard ensure the data is correct and
matches the patient.
14.3.2 Description
General information By inserting a PatientCard (patient card) into the card reader of the
4008 S haemodialysis device, patient-specific treatment parameters
can be exchanged between the haemodialysis device and an external
system (e.g. TDMS).
Download The following patient-specific treatment parameters can be transferred

(downloaded) from the external system (e.g. TDMS) to the
Patient data:
– Patient name or patient ID with date of birth
(depends on SETUP settings)
UF values:
– UF Rate
– UF Goal
– UF Time
– UF Profile Number

Chapter 14: Options
Dialysate data:
– Dialysate flow
– Dialysate temperature
– Base Na+
– Prescribed Na+
– Bicarbonate value
– Start Na+
– Na+ profile number
All transferred treatment parameters must be used on the
haemodialysis device. It is not possible to use individual treatment
parameters only.
Upload To provide a record of the treatment, patient-specific treatment

parameters (e.g. blood pressure measurement data) can be transferred
from the haemodialysis device to the external system.
Messages Messages involving the "Download data for" function are described in a
separate chapter (see Chapter 5.9 on page 5-37).
Messages at the beginning Network error 001 MAC address is corrupted.

of the T1 test Call service support.
Network error 002 SETUP settings are incorrect.
Note
If one of these messages appears at the beginning of the T1 test, the
treatment can be carried out but the "Download data for" function will be
deactivated.
14.3.3 Status indicators for treatment parameter transfer
Fig.: Status indicators for treatment parameter transfer
1 2 3 4
SAMPLE, HAROLD
Preparation
BPM 125 / 56
1 Status display
2 Card reader status
3 Network status
4 Text display

Chapter 14: Options
Once a PatientCard has been inserted, a range of display options are

possible in relation to the "Download data for" function:
Status indicator (1) Condition Representation
Menu selected – Menu (e.g. Ultrafiltration menu).

without blood pressure
measurement
No menu selected – Patient name or

without blood pressure patient ID with date of birth
measurement (depends on SETUP settings).
Menu selected – Menu (e.g. Ultrafiltration menu).

with blood pressure – Data of current or previously measured
measurement blood pressure measurement.
No menu selected – Patient name or

with blood pressure patient ID with date of birth
measurement (depends on SETUP settings)
– Data of current or previously measured
blood pressure measurement.
Card reader status (2) Colour Status
Green – PatientCard inserted.
red – Invalid PatientCard inserted

(before the treatment).
– Invalid or incorrect PatientCard inserted
(during the treatment).
blue – No PatientCard inserted.
Network status (3) Colour Status
Green – Successful login to the network.

– Successful connection to server.
yellow – Successful login to the network.

– No connection to server.
red – No login to the network.

– No connection to server.
blue – Network deactivated

(depends on SETUP settings).

Chapter 14: Options
14.3.4 Insert the PatientCard (patient card)
Label the PatientCard with the complete

name of the patient (1) before the treatment.
(1) Patient name:
Last name First name
(e.g. SAMPLE, HAROLD)
SAMPLE, HAROLD 1 Depending on the settings in the Setup,

ensure that the patient's ID and date of birth
(2) are written on the PatientCard.
(2) Patient ID with date of birth:
Patient ID (12 characters)
Year of birth (YYYY)
Month of birth (MM)
Date of birth (DD)
(e.g. 3A149900003F YYYY-MM-DD)
SAMPLE, HAROLD Ensure the PatientCard has been identified

2 correctly.
3A149900003F YYYY-MM-DD
Insert the PatientCard into the card reader as

shown in the illustration.
The PatientCard chip (3) is on the right.
SAMPLE, HAROLD

Chapter 14: Options
14.3.5 Download – conditions
Treatment parameter transfer (download) is possible only under the

following conditions:
– Network status is green
– T1 test successfully completed
– The UF unit (UF ON/OFF key) must be switched off
– UF volume must be set to 0
– Cumulated blood volume must be set to 0
– Preparation operating mode
(the optical detector in the level detector senses no blood)
– PatientCard detected
– The external system (e.g. TDMS) provides the download data
(depends on SETUP settings)
Note
Once the treatment parameters have been transferred, the parameters
cannot be confirmed until the following conditions have been satisfied:
– No active blood pressure measurement
– No menu selected.
14.3.6 Download – sequence
Warning
Treatment using incorrect treatment parameters
If the assignment of the PatientCard to the patient is not unique,
incorrect treatment parameters (i.e. for a different patient) could be
loaded into the haemodialysis device.
– Ensure the PatientCard is labelled with the complete name of the
patient before the treatment.
– Depending on the settings in the Setup ensure that the patient's ID
and date of birth are written on the PatientCard.
– Before inserting the PatientCard ensure the data is correct and
matches the patient.
Insert the PatientCard

(see Chapter 14.3.4 on page 14-25).
Download data for:
SAMPLE, HAROLD
Message
Once the data has been transferred, the
patient name or patient ID with date of birth
(depending on SETUP settings) is displayed.

Chapter 14: Options
Compare the patient name or patient ID plus

date of birth with the details as given on the
PatientCard.
Warning
The treatment parameters received by the haemodialysis device via the
network must be checked by the operator for plausibility and
must comply with the physician's prescription prior to being applied.
Only after this check the data may be confirmed using the Conf key.
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.

Chapter 14: Options
Press the Conf key.
SAMPLE, HAROLD Preparation

Text display
The patient name or patient ID with date of
birth (depending on SETUP settings) is
displayed by the status indicator (left).
14.3.7 Download – stop
Menu
e.g. Ultrafiltration menu
Press the Esc key.
Info message
Cancel Download
Info message
[Conf/Esc]?
( Select with [Conf] key )
Press the Conf key.

Chapter 14: Options
14.3.8 Upload – conditions
Treatment parameter transfer (upload) is possible only under the

following conditions:
– Network status is green
– PatientCard detected
14.3.9 Upload – sequence
Insert the PatientCard

(see Chapter 14.3.4 on page 14-25).
As soon as the PatientCard has been

inserted, the upload of the treatment
parameters into the external system begins,
regardless of the operating mode of the
In the "Dialysis" operating mode, no further

card changes can be made.
14.3.10 Upload – stop
Standby, T1 test, In the "Standby", "T1 test", "Preparation" and "Reinfusion" operating
Preparation and modes, the treatment parameter upload will be terminated by removing
Reinfusion the PatientCard.
Dialysis During the "Dialysis" treatment, the upload of treatment parameters is

not terminated by removing the PatientCard.
The patient name or patient ID with date of birth (depending on SETUP
settings) continues to be displayed.
No card changes can be made.

Chapter 14: Options

Chapter 15: Appendix
15 Appendix

(IEC 60601-1-2:2007)
Specifications refer to the requirements of IEC 60601-1-2:2007.
15.1.1 Minimum distances between radiation source and device
Medical electric equipment is subject to special precautions with regard

to electromagnetic compatibility (EMC).
Portable and mobile communication devices with high-frequency
transmission power (radiation sources that emit electromagnetic
waves) can affect medical electrical equipment. This can cause the
equipment to malfunction.
Therefore, radiation sources in the vicinity of medical electrical
equipment in use must be kept at a specific minimum distance.
Warning
The use of electrical accessories and lines other than those specified in
the Instructions for Use can lead to an increase in electromagnetic
emissions or a reduction in electromagnetic immunity of the device.
 Only use accessories and lines approved by the manufacturer.
Warning
Patient hazard due to electromagnetic incompatibility of devices
Electromagnetic radiation from other equipment can cause a
malfunction of the device.
 Do not operate the device in the immediate vicinity of other devices.
If operation near or stacked with other equipment is necessary:
 Monitor the device to verify that it is working properly.
Warning
High-frequency radiation (radiation source) can cause this device to
malfunction.
 Observe the minimum required distances to radiated interference
sources.

Radiation technology Minimum distance from Radiation source (examples of

medical electrical equipment, devices)
including all connecting cables
(A radiation source / device may use
more than one type of radiation
technology.)
GSM 3.3 m Mobile phone,

(Global System for Mobile smartphone,
Communications) tablet computer
UMTS
(Universal Mobile
Telecommunications System)
LTE
(Long Term Evolution)
DECT 1.2 m Cordless phone

(Digital Enhanced Cordless
Telecommunications)
WLAN 0.7 m Laptop/notebook,

(Wireless Local Area Network) desktop computer,
E-book reader,
WLAN repeater,
WLAN router,
WLAN access point,
WLAN printer server
Bluetooth 0.2 m Wireless keypad,

wireless mouse,
wireless speakers
Radio 0.1 m Radio remote control (not including

device-specific radio remote
controls from the manufacturer)
If a source of radiated interference uses a radio frequency technology

not specified in the table, the required minimum distance to medical
electrical equipment can be obtained from the manufacturer.

15.1.2 Guidance and manufacturer's declaration on EMC
 Electromagnetic emissions
Guidance and manufacturer's declaration – electromagnetic emissions
Emissions test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1 The 4008 S 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 device is suitable for use in all establishments,
including domestic establishments and those directly
Harmonic emissions Class A connected to the public low-voltage power supply network that
IEC 61000-3-2 supplies buildings used for domestic purposes.
Voltage fluctuations/flicker Complies
emissions IEC 61000-3-3
 Electromagnetic immunity

level 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 or hospital
IEC 61000-4-4 ±1 kV for input / Not applicable environment.
output lines
SurgeIEC 61000-4-5 ±1 kV line(s) to ±1 kV line(s) to Mains power quality should be that of a

line(s) line(s) typical commercial or hospital
±2 kV line(s) to ±2 kV line(s) to environment.
earth earth


level guidance
Voltage dips, short < 5 % UT (> 95 % < 5 % UT (> 95 % If there is an interruption of the power
interruptions and dip in UT) for dip in UT) for supply, the battery of the 4008 S device
voltage variations 0.5 cycle 0.5 cycle takes over the power supply without a
on power supply delay.
input lines 40 % UT (60 % dip 40 % UT (60 % dip
in UT) for 5 cycles in UT) for 5 cycles Mains power quality should be that of a
IEC 61000-4-11
typical commercial or hospital
70 % UT (30 % dip 70 % UT (30 % dip environment.
in UT) for 25 cycles in UT) for 25 cycles
< 5 % UT (> 95 % < 5 % UT (> 95 %

dip in UT) for 5 s dip in UT) for 5 s
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should

(50/60 Hz) magnetic be at levels characteristic of a typical
field IEC 61000-4-8 location in a typical commercial or hospital
environment.
Note: UT is the a.c. mains voltage prior to application of the test level.


level guidance
Portable and mobile RF communications

equipment should be used no closer to
any part of the 4008 S 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 3 Vrms d = 1.17 √P

IEC 61000-4-6 150 kHz to 80 MHz for 150 kHz to < 80 MHz
Radiated RF 3 V/m 3 V/m d = 1.17 √P

IEC 61000-4-3 80 MHz to 2.5 GHz for 80 MHz to < 800 MHz
d = 2.34 √P
for 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
surveya, should be less than the
compliance level in each frequency
rangeb.
Interference may occur in the
vicinity of equipment marked with
the following symbol:
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 device is used exceeds the applicable RF compliance level above, the 4008 S device should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the 4008 S device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

 Recommended separation distances between portable and mobile

RF telecommunications equipment and the device
Recommended separation distances between portable and mobile RF communications equipment and
the 4008 S device
The 4008 S 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 device can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the 4008 S device as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum Separation distance according to frequency of transmitter m

output power of
transmitter 150 kHz to < 80 MHz 80 MHz to < 800 MHz 800 MHz to 2.5 GHz
W d = 1.17 √P d = 1.17 √P d = 2.34 √P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.2 1.2 2.3
10 3.7 3.7 7.4
100 12 12 23
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.

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4008 S

Instructions for Use

Fresenius Medical Care 4008 S IFU-EN-UK 20A-2018 iii

iv Fresenius Medical Care 4008 S IFU-EN-UK 20A-2018

Fresenius Medical Care 4008 S IFU-EN-UK 20A-2018 v

vi Fresenius Medical Care 4008 S IFU-EN-UK 20A-2018

Fresenius Medical Care 4008 S IFU-EN-UK 20A-2018 vii

8 Consumables, accessories, additional equipment

11 Technical Safety Checks / Maintenance

viii Fresenius Medical Care 4008 S IFU-EN-UK 20A-2018

Fresenius Medical Care 4008 S IFU-EN-UK 20A-2018 ix

x Fresenius Medical Care 4008 S IFU-EN-UK 20A-2018

Fresenius Medical Care 4008 S IFU-EN-UK 20A-2018 1-1

Heparin pump, stop time 7-25 O Service life, expected 2-6

Operation status indicator (traffic Single measurement, BPM 14-19

N S Vent tubing 3-2

1-2 Fresenius Medical Care 4008 S IFU-EN-UK 20A-2018

Fresenius Medical Care 4008 S IFU-EN-UK 20A-2018 1-3

1-4 Fresenius Medical Care 4008 S IFU-EN-UK 20A-2018

2.1 How to use the Instructions for Use

Footer The footer contains the following information:

Keys Keys on the device are shown in bold type.

Status indicators Status indicators on the device are shown in

Fresenius Medical Care 4008 S IFU-EN-UK 20A-2018 2-1

Marking in the illustrations

Rays around an LED / indicator:

Changes Changes to documents will be released as new editions or

Reproduction Reproduction, even in part, is only permitted with written approval.

2.2 Significance of warnings

2.3 Significance of notes

2-2 Fresenius Medical Care 4008 S IFU-EN-UK 20A-2018

2.4 Brief description

The 4008 S haemodialysis device allows dialysis treatments without

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2.5 Intended use

2.5.1 Intended purpose

The device is used for the extracorporeal blood treatment of patients

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2.5.2 Specification of the use

2.5.3 Side effects

Haemodialysis therapies occasionally cause hypotension, nausea,

– Hyperkalemia (for potassium-containing haemodialysis

2.5.6 Target group

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2.5.7 Repair / maintenance / transport

Technical Safety Checks, maintenance points and further explanations

2.5.8 Expected service life

2.5.9 Interaction with other systems

Due to friction at the pump segment, very low electrostatic discharges

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2.6 Duties of the responsible organisation

The responsible organisation must ensure:

2.7 Operator responsibility

The following must be observed when entering parameters (especially

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2.8 Disclaimer of liability

2.9 Use of consumables

Please note the symbols printed on the packaging of the consumables