4008 B / 4008 H / 4008 S Hemodialysis Device Technical Manual

4008 B / 4008 H / 4008 S
Hemodialysis Device
Technical Manual
Software version: ≥ 4.5 / ≥ 5.3
Edition: 12A-2016
Part no.: F40003413
0123
Table of contents
1 Important information on the Technical Manual

1.1 How to use the Technical Manual ............................................................................................ 1-1
1.2 Significance of warnings .......................................................................................................... 1-2
1.3 Significance of notes ................................................................................................................ 1-2
1.4 Precautions for working on the device ................................................................................... 1-2
1.5 Addresses .................................................................................................................................. 1-4
2 Description of device functions and errors

2.1 Description of the T1 Test ........................................................................................................ 2-1
2.1.1 T1 test flow diagram, serial.......................................................................................................... 2-1
2.1.2 T1 test flow diagram, parallel....................................................................................................... 2-4
2.1.3 Description of the T1 Test including errors.................................................................................. 2-6
2.1.4 Description of device errors during the cleaning programs ....................................................... 2-50
2.1.5 Error messages after turning the power on ............................................................................... 2-68
2.1.6 Error messages during dialysis ................................................................................................. 2-69
2.2 Functional description of the modules ................................................................................. 2-76
2.2.1 Blood pump (arterial) ................................................................................................................. 2-76
2.2.2 Blood pump (Single Needle), option.......................................................................................... 2-77
2.2.3 Heparin pump ............................................................................................................................ 2-78
2.2.4 Level detector ............................................................................................................................ 2-81
2.3 Functional description of the hydraulics .............................................................................. 2-82
2.3.1 Description of the hydraulics unit............................................................................................... 2-84
2.3.2 Functional principle of the balancing chamber .......................................................................... 2-86
2.3.3 Optional Central Delivery System.............................................................................................. 2-90
2.3.4 Program sequences in cleaning programs ................................................................................ 2-91
2.4 External alarm input messages............................................................................................ 2-101
3 Installation and Technical Safety Checks / maintenance procedures

3.1 Initial start-up............................................................................................................................. 3-1
3.1.1 Important information on initial start-up ....................................................................................... 3-1
3.1.2 Initial start-up report..................................................................................................................... 3-2
3.1.3 Explanatory notes for completing the initial start-up report ......................................................... 3-6
3.2 Technical Safety Checks / maintenance procedures........................................................... 3-23
3.2.1 Important information on TSC / MA ........................................................................................... 3-23
3.2.2 TSC / MA report......................................................................................................................... 3-23
3.2.3 Explanatory notes for completing the TSC / MA report ............................................................. 3-29
3.2.3.1 Notes – Check of the electrical safety ................................................................... 3-39
3.2.4 TSC report ................................................................................................................................. 3-41
3.3 Decommissioning.................................................................................................................... 3-45
Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016 iii

3.3.1 Important information on decommissioning ............................................................................... 3-45
3.3.2 Articles required to perform decommissioning........................................................................... 3-45
3.3.3 Decommissioning report and identification sheet ...................................................................... 3-45
3.3.4 Explanatory notes on the decommissioning report and identification sheet .............................. 3-48
3.4 Decommissioning extension .................................................................................................. 3-54
3.4.1 Important information on decommissioning extension............................................................... 3-54
3.4.2 Articles required to perform decommissioning extension .......................................................... 3-54
3.4.3 Decommissioning extension report............................................................................................ 3-54
3.4.4 Explanatory notes for completing the decommissioning extension report................................. 3-56
3.5 Recommissioning after decommissioning ........................................................................... 3-58
3.5.1 Important information on recommissioning after decommissioning........................................... 3-58
3.5.2 Articles required to perform recommissioning after decommissioning ...................................... 3-58
3.5.3 Recommissioning report after decommissioning ....................................................................... 3-58
3.5.4 Explanatory notes for completing the recommissioning report after decommissioning ............. 3-60
3.6 Removal from service ............................................................................................................. 3-64
3.6.1 Important information on removal from service ......................................................................... 3-64
4 Adjustment instructions
4.1 Overview of the DIP switches in the 4008 ............................................................................. 4-10
4.1.1 PCB LP631 (CPU1) DIP switch array 1 .................................................................................... 4-10
4.2 Calibration mode ..................................................................................................................... 4-14
4.2.1 Basic conditions......................................................................................................................... 4-14
4.2.2 Messages on the displays on the UF monitor (4008 B) or on the screen (4008 H/S) ............... 4-15
4.3 Hydraulics ................................................................................................................................ 4-16
4.3.1 Reduced water inlet pressure .................................................................................................... 4-16
4.3.2 Degassing pressure................................................................................................................... 4-18
4.3.3 Balancing chamber loading pressure ........................................................................................ 4-20
4.3.4 Flow pump pressure .................................................................................................................. 4-22
4.3.5 UF pump volume ....................................................................................................................... 4-24
4.3.6 CDS (Central Delivery System) pressure switch ....................................................................... 4-27
4.3.7 Checking the bibag® pressure transducer (Envec) ................................................................... 4-29
4.4 Level detector .......................................................................................................................... 4-30
5 Calibration program
6 Diagnostics program
6.1 General information................................................................................................................... 6-1
6.2 Menu structure........................................................................................................................... 6-3
6.3 Reading the analog inputs of CPU1......................................................................................... 6-5
6.4 Reading the analog inputs of CPU2......................................................................................... 6-7
iv Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016

6.5 Reading the digital inputs of CPU1.......................................................................................... 6-8
6.6 Reading the digital inputs of CPU2........................................................................................ 6-13
6.7 Setting the analog outputs of CPU1 ...................................................................................... 6-17
6.8 Setting the analog outputs of CPU2 ...................................................................................... 6-18
6.9 Setting the digital outputs of CPU1 ....................................................................................... 6-19
6.10 Setting the digital outputs of CPU2 ....................................................................................... 6-25
6.11 Setting / reading the digital outputs of CPU1 ....................................................................... 6-28
6.12 ONLINEplus™ Module ............................................................................................................ 6-29
6.13 HPU ........................................................................................................................................... 6-30
7 Setup menu
7.1 Overview of Setup menu settings............................................................................................ 7-1
7.2 Overview..................................................................................................................................... 7-4
7.3 Main menu for 4008 B ............................................................................................................... 7-5
7.4 Main menu for 4008 H/S .......................................................................................................... 7-30
8 Miscellaneous
9 Circuit diagrams and circuit descriptions

9.1 Block diagram 4008................................................................................................................... 9-1
9.2 Voltage supply block diagram.................................................................................................. 9-2
9.3 Block diagram of screen 4008 H/S........................................................................................... 9-3
9.4 HPU wiring diagram .................................................................................................................. 9-4
9.4.1 Connection diagram CAN communication................................................................................... 9-5
9.4.2 Hydraulics processor block diagram............................................................................................ 9-6
9.5 PCB LP450-2 Level detector control (LD) ............................................................................... 9-7
9.6 PCB LP493 Blood leak detector............................................................................................... 9-9
9.7 PCB LP624 Control board (BP) .............................................................................................. 9-10
9.8 PCB LP 630 Motherboard ....................................................................................................... 9-11
9.9 PCB LP 631 CPU1.................................................................................................................... 9-12
9.10 PCB LP 632 CPU2.................................................................................................................... 9-14
9.11 PCB LP 633 Input board.......................................................................................................... 9-16
9.12 PCB LP 634 Output board....................................................................................................... 9-18
9.13 PCB LP 636 External connectors........................................................................................... 9-20
9.14 PCB LP 950 Control board (HEP)........................................................................................... 9-21
Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016 v

9.15 PCB LP 644-4 Display board (HEP)........................................................................................ 9-22
9.16 PCB LP645 Position sensor membrane pump ..................................................................... 9-23
9.17 PCB LP 649-2 Display board (4008 B/S) ................................................................................ 9-24
9.18 PCB LP742 Interference filter................................................................................................. 9-26
9.19 PCB LP748 Display board (BP) .............................................................................................. 9-27
9.20 PCB LP763 Multi interface board (COMMCO III)................................................................... 9-28
9.21 PCB LP 922 Display board (4008 S) ....................................................................................... 9-29
9.22 PCB LP923 Traffic light (4008 H/S) ........................................................................................ 9-30
9.23 PCB LP 924 Display board (4008 H)....................................................................................... 9-31
9.24 PCB LP 928 CAN bus distributor ........................................................................................... 9-32
9.25 PCB LP 941 Hydraulic processing unit ................................................................................. 9-33
9.26 Heater board (power supply unit 4008) ................................................................................. 9-34
9.27 Power board (power supply unit 4008).................................................................................. 9-35
vi Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016

Chapter 1: Important information on the Technical Manual
1 Important information on the Technical

Manual
1.1 How to use the Technical Manual
Device name The device 4008 B / 4008 H / 4008 S will be referred to as the device in
the following.
Purpose This document is intended for service technicians and is to be used for
first studies (to acquire a basic knowledge) and for reference purposes
(for Technical Safety Checks, maintenance procedures, and repairs).
The document, however, does not replace the training courses offered
by the manufacturer.
Identification The document can be identified by the following information on the title
page and on the labels, if any:
– Edition of the document
– 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., TM-EN refers to the
Technical Manual in English.
– The editorial identification, for example 4A-2013, refers to edition 4A
released in 2013
– The page identification, for example 1-3, refers to Chapter 1, page 3.
Styles used in the The following text styles may be used in the document:
document
Style Description
Keyboard shortcut Keys on the device are shown in bold type.

Example: Example key.
Messages Messages on the device are shown in bold

type.
Example: Message: Sample message.
Illustrations The illustrations used in the documents may differ from the original if
this does not have any influence on the function.
Changes Changes to the document will be released as new editions or

supplements. In general: This manual is subject to change without
notice.
Reproduction Reproduction, even in part, is only permitted with written approval.
Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016 1-1

1.2 Significance of warnings
Warning
Advises the operator that failure to observe this information can result
in personal injury.
1.3 Significance of notes
Note
Advises the operator that failure to observe this information can result
in the following:
– Damage to the device.
– Specific functions not being executed at all or not being executed
correctly.
1.4 Precautions for working on the device
Warning
Risk of infection
Contamination of the device with blood results in a risk of infection.
The following must be observed to avoid an infection:
– Wear protective gloves.
– Disinfect your hands after removing the gloves.
– Wear a surgical mask and goggles if there is a risk of splashes and
aerosols.
– Clean and disinfect the device before handling.
Warning
Risk of infection
Contamination of the device with blood results in a risk of infection.
If there is a possibility that fluid might have passed through the
hydrophobic filter, the device must be checked for contamination after
the treatment.
If the device is contaminated, it must be removed from service. Before
starting the device again, all affected parts must be replaced in
accordance with the manufacturer’s specifications.
1-2 Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016

Requirements Knowledge of the current Instructions for Use for the respective device.
Background experience in mechanics, electrical, and medical
engineering.
Authorized persons
Warning
Start-up, extensions, adjustments, calibrations, maintenance
procedures, modifications, or repairs may only be carried out by the
manufacturer or persons authorized by the manufacturer.
Test equipment and The activities described in this document require the availability of the
accessories necessary technical test equipment and accessories.
Specifications Technical data is provided in the current version of the Instructions for
Use and must be observed.
Precautions Before turning the power on, repair any visible damage.
Prior to opening the device and when working on the open device, the
following precautions have to be observed:
– Protect the components against ingress of fluids.
– Do not touch live parts.
– All plugs, connections, and components must only be disconnected
or connected when the device is turned off.
ESD precautions When repairing the device and replacing spare parts, observe the
relevant ESD precautions.
Hygienic measures The device and the consumables are generally considered to be
contaminated and must therefore be sufficiently disinfected by the
operator as specified by the manufacturer.
Warning
When the device is returned to use, check that the pressure of the water
supply meets the prescribed minimum pressure.
To be observed after A disinfection, a T1 test, and a check of the electrical safety must be
working on the device performed after working on the device.
The current Instructions for Use must be enclosed with the device.
Additional operator training may be required.
Spare parts Use only original spare parts.

For identifying and ordering spare parts, test equipment, and
accessories, always use the electronic spare parts catalog.

1.5 Addresses
Manufacturer Fresenius Medical Care AG & Co. KGaA

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

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

Chapter 2: Description of device functions and errors
2 Description of device functions and

errors
2.1 Description of the T1 Test
2.1.1 T1 test flow diagram, serial

MODULE TEST
T1 BATTERY
START T1 TEST
TEST OK No SAVE ERROR NUMBER
?
Yes
TEST TEST
BYPASS BLOOD LEAK DETECTOR
No SAVE ERROR NUMBER TEST OK No SAVE ERROR NUMBER

TEST OK
? ?
Yes Yes
TEST TEST
OPT. DETECTOR TEMPERATURE
TEST OK No SAVE ERROR NUMBER TEST OK No SAVE ERROR NUMBER

? ?
Yes Yes
TEST TEST
BLOOD SYSTEM NEG. PRESSURE HOLDING

? ?
Yes Yes
TEST TEST
VENOUS PRESSURE SYSTEM POS. PRESSURE HOLDING

? ?
Yes Yes
TEST TEST
LEVEL DETECTOR UF FUNCTION

? ?
Yes Yes
TEST TEST
DISPLAY CONDUCTIVITY
No SAVE ERROR NUMBER TEST OK No SAVE ERROR NUMBER

TEST OK
? ?
Yes Yes
TEST Hydraulics without HPU Hydraulics with HPU

ARTERIAL PRESSURE SYSTEM
TEST DIASAFE PLUS /
TEST
ONLINE PLUS /
DIASAFE / HDF FILTER
HPU TEST
No SAVE ERROR NUMBER

TEST OK
?
TEST OK No SAVE ERROR NUMBER

Yes ?
Yes

T1 TEST Yes
FAILED DIALYSIS START KEY
No
INCORRECT
TEST STEP
RETURN
TEST OK No DISPLAY ERROR

?
Yes
FURTHER
Yes NEXT INCORRECT TEST
INCORRECT
TEST STEPS STEP
No
RETURN

2.1.2 T1 test flow diagram, parallel
MODULE
T1
START T1 TEST
TEST TEST TEST TEST TEST TEST ARTERIAL

OPT. DETECTOR BLOOD SYSTEM BYPASS DISPLAY BATTERY PRESSURE SYSTEM
TEST OK Yes TEST OK Yes TEST OK Yes TEST OK Yes TEST OK Yes TEST OK Yes
? ? ? ? ? ?
No 1 No No No 1 No 1 No 1
SAVE ERROR NUMBER SAVE ERROR NUMBER SAVE ERROR NUMBER SAVE ERROR NUMBER SAVE ERROR NUMBER SAVE ERROR NUMBER
TEST VENOUS TEST

PRESSURE SYSTEM TEMPERATURE
Yes Yes
TEST OK TEST OK
? ?
No No
SAVE ERROR NUMBER SAVE ERROR NUMBER
TEST TEST TEST

LEVEL DETECTOR NEG. PRESSURE HOLDING BLOOD LEAK DETECTOR
Yes Yes Yes

TEST OK TEST OK TEST OK
? ? ?
No 1 No No 1
SAVE ERROR NUMBER SAVE ERROR NUMBER SAVE ERROR NUMBER
TEST No Yes TEST

POS. PRESSURE HOLDING Conductivity? CONDUCTIVITY
TEST OK Yes TEST OK Yes

? ?
No No
TEST TEST TEST POSITIVE

CONDUCTIVITY UF FUNCTION PRESSURE HOLDING
TEST OK Yes TEST OK Yes TEST OK Yes

? ? ?
No No No
SAVE ERROR NUMBER SAVE ERROR NUMBER SAVE ERROR NUMBER
Hydraulics without HPU Hydraulics with HPU

TEST
DIASAFE / HDF FILTER TEST TEST TEST DIASAFE PLUS /
UF FUNCTION DIASAFE / HDF FILTER ONLINE PLUS /
HPU bTEST
TEST OK Yes
? TEST OK Yes TEST OK Yes
? ?
No 1
No 1 No 1
SAVE ERROR NUMBER

T1 TEST FAILED Yes

DIALYSIS START KEY
No
INCORRECT TEST STEP
RETURN
TEST OK No
? DISPLAY ERROR
Yes
FURTHER No NEXT INCORRECT TEST STEP

INCORRECT TEST
STEPS
Yes
RETURN

2.1.3 Description of the T1 Test including errors
 Conditions for starting and running the test
Error message Description
Power failure Power failure while the test is in progress.
Dialines not conn? The dialyzer tubes are not in the shunt interlock.
Shunt cover open? The shunt interlock is open.
Connect Conc.Line The concentrate connector is in the rinse chamber, or concentrate is

Wrong conc. supply not connected at all. The error message depends on the Central
Delivery System preselected in the setup menu.
Blood sensed by OD The optical detector senses blood in the system.
Flow alarm Tube to or from the dialyzer kinked, malfunctions in the hydraulics.
Water alarm Water supply interrupted.
XXX not calibrated No valid calibration value in NOVRAM.
 Overview of the individual test sections
Bypass test (see Bypass test on page 2-7)

Optical detector test (see Optical detector test on page 2-9)
Blood system test (see Blood system test on page 2-11)
Venous pressure system test (see Venous pressure system test on page 2-15)
Level detector test (see Level detector test on page 2-17)
Display test (see Display test on page 2-20)
Arterial pressure system test (see Arterial pressure system test on page 2-22)
Battery test (see Battery test on page 2-24)
Blood leak test (see Blood leak test on page 2-26)
Temperature test (see Temperature test on page 2-28)
Negative pressure holding test (see Negative pressure holding test on page 2-30)
Positive pressure holding test (see Positive pressure holding test on page 2-32)
UF function test (see UF function test on page 2-37)
Conductivity test (see Conductivity test on page 2-40)
Diasafe / HDF Filter test (see Diasafe / HDF Filter test on page 2-42)
Online plus / Diasafe plus filter / (see Online plus / Diasafe plus filter / HPU test on page 2-46)
HPU test

 Bypass test
Test description Check of the following functions:

– Heater relay
– Bypass (electric)
– Check of the temperature range switching function
Illustration
X632/A26 HOT_RINSE
LP 639
(4008H)
X639/
Power A20
Logic
X632/A10 H_REL_W X639/A12
X632/A9 EM_H_OFF X639/A17
LP 647
(4008S/B)
X632/C25 V24_EN
X632/C26 V24B_EN
X632/B22 CI
LP 632
X632/A6 V26
CPU 2
X632/A6 V26
X632/A5 V24B X634R/ X634R/
X632/A4 V24 A18 C22
X632/B27 X632/B28 LP 634

LP 633
X634R/ Output X634R/
Input A23 board C24
board
X634L/C25
X634L/A25
X634L/C12
X631/A20 X631/A21
LP 631
LP 630 DATA BUS
CPU 1
Mother
board
V24B
V24
V26
Display
board
LP 649
(4008 B) V24 V24B V26
LP 924 LP 922
(4008 H) (4008 S)
Testgenerierung/Generation of Test
Rueckmeldung/Acknowledgement

Error description
F01 Bypass The heater relay is switched off.

– Acknowledgment (H_REL_W, X639/A12) → X632/A10,
0 V missing.
F02 Bypass The heater relay cannot be switched off by CPU2.

– Acknowledgment (H_REL_W, X639/A12) → X632/A10,
12 V missing.
– Control line (EM_H_OFF, X632/A9) → X639/A17, 12 V missing.
F03 Bypass The temperature measurement range is set to hot rinse.

– Control line (HOTRINSE, X634R/C24) → X639/A20, 0 V missing.
– Acknowledgment (HOTRINSE, X634R/C24) → X632/A26,
0 V missing.
F04 Bypass The extended bypass cannot be correctly switched by CPU2

(V24 = off, V26 = on, V24B = off).
– Acknowledgment (V24, X637/C1) → X632/A4, 24 V missing.
– Acknowledgment (V24B, X637/C23) → X632/A5, 24 V missing.
F05 Bypass The extended bypass cannot be correctly switched off by CPU2
(V24 = on, V26 = off, V24B = on).
F06 Bypass CPU1 cannot set the temperature control to hot rinse.
12 V missing.
F07 Bypass The extended bypass cannot be correctly switched by CPU1

(V24 = off, V26 = on, V24B = off).
F08 Bypass CPU1 cannot reset the temperature control to dialysis.

0 V missing.
F09 Bypass The extended bypass cannot be correctly switched off by CPU1
(V24 = on, V26 = off, V24B = on).
F95 Bypass System error

 Optical detector test
Test description Attenuation of the optical detector.

Check of the acknowledgment of the optical detector.
Illustration
LP 632 X632/C16 LDSA
CPU 2 X632/C15 ODSA
X632/A30 OD_OUT
X633L/C7
X632/B27 X632/B28 LP 633 LP 634

Input Output
board board
X633L/C8
OD_IN
X631/A20 X631/A21
LP 631
LP 630 DATA BUS
CPU 1
Mother
board
X351/5 X351/7
Display Pven
board X351/10
LP 649
(4008 B)
LP 924 LP 922
(4008 H) (4008 S)

Error description
F01 opt. Detector CPU1 and CPU2 interpret the optical detector differently.
– Acknowledgment (OD_OUT, X633L/C7) → X632/A30 and the
digital input of PCB LP633 measure different levels.
F02 opt. Detector CPU2 fails to recognize blood in the system.

– Acknowledgment (OD_OUT, X633L/C7) → X632/A30,
0 V missing.
– Detuning (ODSA, X632/C15) → X351/7, 12 V missing.
F03 opt. Detector CPU1 fails to recognize blood in the system.

– Acknowledgment (OD_OUT, X633L/C7) → Digital input on
– PCB LP 633.
– Detuning (ODSA, X632/C15) → X351/7, 12 V missing.
F04 opt. Detector CPU2 recognizes that the optical detector senses blood (required
because of the test in the cleaning program).
– Acknowledgment X632/A30, 12 V missing.
– AD28 defective.
F95 opt. Detector System error

 Blood system test
Test description Check of the following functions:

– Blood alarm acknowledgment
– Blood pump stop
Illustration
X632/C10 CLP_CTL
X632/C14 LDA2
X632/C21 BL_AL
LP 632
X632/B11 BPSB_VEN
CPU 2
X632/A11 BPSB_ART
X632/A15 SN_ART X634L/

C15
X632/B27 X632/B28
LP 633
X634L/ LP 634
A14 (4008H)
Input A15 Output
board board
BPST_ART
LP 647
(4008S/B)
X633L/ A13 X633L/ X634L/ B15 X634L/
C13 B14 C14
X631/A20 X631/A21
LP 631
BPSST_A
LP 630 DATA BUS
CPU 1
Mother
BPSST_V
board
X348/V1
X348/V3
X348/V6
X348a/1
X348a/3
X348a/6
X348a/2
X351/8
X351/6
Pven
Display
board
LP 649
(4008 B)
LP 924 LP 922
(4008 H) (4008 S)
Rückmeldung/Acknowledgement

Error description
F09 Blood system Acknowledgment that CPU2 detects that the arterial blood pump is
inactive (blood pump not running).
– Acknowledgment (BPSB_ART, X348a/6) → X632/A11,
12 V missing.
– Control line (BPSTT_ART, X634L/B14) → X348a/1, 12 V missing
or (BPST_ART, X634L/A14) → X348a/3, 12 V missing.
F10 Blood system Acknowledgment that CPU1 detects that the arterial blood pump is
inactive (blood pump not running).
– Acknowledgment (BPSB_ART, X348a/6) → X633L/A11,
12 V missing.
or (BPST_ART, X634L/A14) → X348a/3, 12 V missing.
– Level is raised during the T1 test.
F11 Blood system The arterial blood pump cannot be stopped by CPU1.
CPU2 recognizes that the arterial blood pump remains active.
and (BPST_ART, X634L/A14) → X348a/3, 0 V missing.
– Acknowledgment (BPSB_ART, X348a/6) → X632/A11,
0 V missing.
– The level is raised during the T1 test, or the up / down key on the
level detector is blocked and constantly raised.
The level is raised.
F12 Blood system The arterial blood pump cannot be stopped by CPU1.
CPU1 recognizes that the arterial blood pump remains active.
– Control line (BPSTT_A, X634L/B14) → X348a/1, 0 V missing and
(BPST_ART, X634L/A14) → X348a/3, 0 V missing.
– Acknowledgment (BPSB_ART, X348a/6) → X633L/A11,
0 V missing.
F13 Blood system Applicable for SW 4.91/2.91 and higher if SN, ONLINE-HDF, or
4008HDF pump is connected (= ADKS active)
Acknowledgment that CPU2 detects that the pump is inactive (pump
is not running).
– Acknowledgment (BPSB_VEN, X348V/6) → X632/B11,
12 V missing.
– Control line (BPSST_VEN, X634L/B15) → X348V/1, 12 V missing
or (BPST_VEN, X634L/A15) → X348V/3, 12 V missing.
– Transistor T9 on PCB LP754 defective.
– IC5 on PCB LP632 defective.
– In 4008 HDF, an HDF treatment was performed, followed by a
cleaning program with the substituate pump running, then the
T1 test has been re-started.
Substituate pump must be switched off otherwise the test step will
not be passed. (Problem was corrected with SW 3.20 in 4008 H/S:
The substituate pump will be switched off automatically on starting
a cleaning program).

Acknowledgment that CPU1 detects that the pump is inactive (pump
is not running).
– Acknowledgment (BPSB_VEN, X348V/6) → X633L/A13,
12 V missing.
or (BPST_VEN, X634L/A15) → X348V/3, 12 V missing.
– PCB LP 633 detects Single-Needle pump although it is not
connected.
CPU1 fails to stop the corresponding blood pump.
CPU2 detects that the pump remains active.
and (BPST_VEN, X634L/A15) → X348V/3, 0 V missing.
0 V missing.
– Transistor T9 on PCB LP754 defective.
– During the test, the tubing system is inserted on the corresponding
pump using the Start / Stop key.
connected.
CPU1 fails to stop the corresponding blood pump.
CPU1 detects that the pump remains active.
and (BPST_VEN, X634L/A15) → X348V/3, 0 V missing.
0 V missing.
connected.
F17 Blood system Applicable for SW 4.91/2.91 and higher, check of ADKS signal
(= ADKS not active)
Although the recognition of the venous blood pump (ADKS) is not
acknowledged, the 24 V supply voltage of the pump can be switched
off.
– Acknowledgment line (ADKS, X348V/7) → X633L/A10,
12 V missing.
12 V missing.
12 V missing.
– Online-HDF has already been switched on during the T1 test.

F18 Blood system Applicable for SW 5.00/4.10 and higher, check of the BPUS signal
(CPU2, PCB LP632)
At the beginning of the test step a maximum of 40 seconds may pass
until rotation has stopped. If the blood pump is being activated, the
rotation stop alarm must have been cleared.
– Acknowledgment line (BPUS, X348A/8) → X632/A13, 0 V missing.
– Acknowledgment line (BPUS, X348A/8) → X632/A13,
12 V missing.
– Blood pump speed is set to "0": Preset speed during the T1 Test.
F19 Blood system Applicable for SW 5.00/4.10 and higher, check of the BPUS signal
(CPU1, PCB LP631 via PCB LP633)
At the beginning of the test step a maximum of 40 seconds may pass
until rotation has stopped. If the blood pump is being activated, the
rotation stop alarm must have been cleared.
– Acknowledgment line (BPUS, X348A/8) → X633L/A12,
0 V missing.
– Acknowledgment line (BPUS, X348A/8) → X633L/A12,
12 V missing.
F20 Blood system Check of the actual arterial BP rate.

The actual rate of the arterial BP is not zero. The actual rate of the
arterial BP does not increase.
If SN is installed: The actual rate of the venous BP is not zero. The
actual rate of the venous BP does not increase.
– Acknowledgment line (BPR_ART, X348A/10) → X633L/B3,
0 V missing or acknowledgment line (BPR_ART, X348A/10) →
X632/A14, 0 V missing.
– Acknowledgment line (BPR_ART, X348A/10) → X633L/B3, no
increase or acknowledgment line (BPR_ART, X348A/10) →
X632/A14, no increase
If SN is installed:
– Acknowledgment line (BPR_VHDF, X348V/10) → X633L/B4,
0 V missing
– Acknowledgment line (BPR_VHDF, X348V/10) → X633L/B4, no
increase
F95 Blood system System error

 Venous pressure system test
Test description Verification of the lower limit by checking the venous zero point. The
upper limit is tested by detuning the venous pressure unit in positive
direction. (The venous occlusion clamp is closed during the test.)
Illustration
LP 632
X632/C16 LDSA
CPU 2
X632/C18 PV_DET
X632/C17 P_VEN
X632/B27 X632/B28
LP 633 LP 634
Input Output
board board
X633L/B5 X634R/C18
VENT_V
X631/A20 X631/A21
LP 631
CPU 1 LP 630 DATA BUS
Mother
board
X351/1 X351/2
P VEN
Display
board
LP 649
(4008 B) X351/4 X351/10
LP 924 LP 922
(4008 H) (4008 S)

Error description
F01 Venous CPU1 (input board) shows a venous zero point deviation of more than
±12 mmHg (60 seconds).
– Control (VENT_VALVE, X634R/C18) → X351/1 of the vent valve
in the LD is defective.
– Acknowledgment (P_VEN, X351/4) → X633L/B5, voltage value is
outside zero point tolerance.
– P-venous not calibrated.
F02 Venous CPU2 has a venous zero point deviation of more than ±12 mmHg
(60 seconds).
– Control (VENT_VALVE, X634R/C18) → X351/1 of the vent valve
in the LD is defective.
– Acknowledgment (P_VEN, X351/4) → X632/C17, voltage value is
outside zero point tolerance.
F03 Venous With detuning in positive direction, the achieved change in the venous
display is less than 100 mmHg (7 seconds).
– Test detuning defective (PV_DET, X632/C18) → X351/2.
– Acknowledgment (P_VEN, X351/4) → X633L/B5, the change in
voltage is too low.
F04 Venous The deviation in the measured value between CPU1 and CPU2 is
more than ±12 mmHg (if Pven > 100 mmHg).
– Acknowledgment (P_VEN, X351/4) → X633L/B5 and X632/C17
measure different voltage values.
F95 Venous System error

 Level detector test
Test description – Test of the level detector by checking the alarm state.
– Switch-off of the venous occlusion clamp in the level detector
module.
Illustration
Display
board
LP 649
(4008 B)
LP 924 LP 922
(4008 H) (4008 S)

Error description
F01 Level detector CPU1 and CPU2 interpret level detector signal differently.
– Acknowledgments (LDA1, X351/14) → X632/C13 and X633L/C10
recognize different signal levels.
F02 Level detector The level detector alarm is not detected by CPU2.
– Acknowledgment (LDA1, X351/14) → X632/C13, 0 V missing.
– Transmission weakening (LDSA, X632/C16) → X351/10,
12 V missing.
F03 Level detector Level detector clamps acknowledgment (CPU2) activated (clamp
closed)
– Clamp control (CLP_CTL, X634L/C14) → X351/8, 12 V missing.
– Clamp control (CLP_CTL, X632/C10) → X351/8, 12 V missing.
closed)
– Acknowledgment (LDA2, X351/6) → X633L/C13, 24 V missing.
F05 Level detector The blood alarm signal has not been cleared (indicates an alarm).
– Acknowledgment (BL_AL, X634L/C15) → X632/C21,
12 V missing.
If the HDF option is used, this signal is not tested (special function).
F06 Level detector The level detector clamp could not be closed via the CPU2 control line.
F07 Level detector The level detector clamp could not be opened via the CPU2 control
line.
F08 Level detector The level detector clamp could not be closed via the CPU1 control line,
or the CPU2 acknowledgment is incorrect.
F09 Level detector The level detector clamp could not be closed via the CPU1 control line,
or the CPU1 acknowledgment is incorrect.
F10 Level detector No blood alarm message.

– Acknowledgment (BL_AL, X634L/C15) → X632/C21, 0 V missing.
closed)

closed)
F13 Level detector The blood alarm signal has not been cleared (indicates an alarm).
– Acknowledgment (BL_AL, X634L/C15) → X632/C21,
12 V missing.
F14 Level detector Raise level key on the level detector is constantly active.
– Acknowledgment (LEVEL_UP, X351/3) → X632/C11, 0 V missing.
F15 Level detector Acknowledgment of mains power for ultrasonic output stage after
3 seconds not between 6.5 and 13.5 V
– Adapter board AD28 not connected.
– Acknowledgment (X351/11 → X633L/25A jumper to X633L/B7)
12 V missing.
– Relay on AD28 failed to drop.
3 seconds not > 14.5 V.
– Acknowledgment (X351/11 → X633L/25A jumper to X633L/B7), no
voltage 16 V/24 V.
– Relay on AD28 is not tripped.
– No 10 Hz signal at ALARM_REST (X351/12)
3 seconds not between 6.5 and 13.5 V
– Acknowledgment (X351/11 → X633L/25A jumper to X633L/B7)
12 V missing.
– Relay on AD28 failed to drop
F95 Level detector System error

 Display test
Test description Check of all displays and indicators on the monitor front
– Display test
– Status LED
– Alarm LED
– Seven-segment display, all dark
– Seven-segment display, all 8888
– Bar graph
– CPU1 / CPU2 audible alarm
This display test must be monitored by the user!
Illustration
LP 632 X632/C29 CPU2_AL
CPU 2
X634R/A16
LP 633 LP 634
X632/ B27 X632/ B28 Input Output
board board
+LS X634L/A13
-LS X634L/B13
X631/ A20 X631/ A21
LP 631
LP 630 DATA BUS
CPU 1
Mother
board
Display
board Test Display
LP 649
(4008 B) 8888
LP 924 LP 922 8888

(4008 H) (4008 S)
8888
8888

Error description
F01 Display CPU1 failed to start the display test within 5 seconds.
– The "test started" information transmitted via the serial interface is
missing.
F02 Display CPU1 failed to complete the display test within 120 seconds.
– The "test completed" information transmitted via the serial interface
is missing.
F95 Display System error

 Arterial pressure system test
Test description Test of the arterial pressure unit by electronic detuning in positive or
negative direction.
Illustration
Display
board
LP 649
(4008 B)

Error description
F01 Arterial With detuning in negative direction, the change achieved on the
arterial display is less than 100 mmHg (2 seconds).
– Acknowledgment (P_ART, X348A/7) → X633L/B12, insufficient
voltage change.
– Test detuning defective (PA_DET, X632/A17) → X348A/9.
F02 Arterial With detuning in positive direction, the change achieved on the arterial
display is less than 100 mmHg (2 seconds).
– Acknowledgment (P_ART, X348A/7) → X633L/B12, insufficient
voltage change.
– Test detuning defective (PA_DET, X632/A17) → X348A/9.
F95 Arterial System error

 Battery test
Test description Check of the battery voltage under load.
Illustration
TESTBATT
LP 632
CPU 2
X634R/C23 X639/A10
LP 633 LP 634 LP 639

(4008H)
X632/B27 X632/B28 Input Output Power
board board Logic
LP 647
(4008S/B)
X633L/B21 X639/A2
X639/A3
X639/A4
X631/A20 X631/A21
LP 631
LP 630 DATA BUS
CPU 1
Mother U_ACCU
board
Akku (16 - 22V)
Display
board
LP 649
(4008 B)
LP 924 LP 922
(4008 H) (4008 S)

Error description
F01 Battery CPU1 failed to complete the battery test within 5 seconds.
– The "test completed" information transmitted via the serial interface
is missing.
F02 Battery The battery charge is insufficient for 1 minute of audible alarm (maybe
no battery connected).
– The battery voltage (U_ACCU, ...) → X633L/B21 dropped below
17.6 V.
– Acknowledgment (U_ACCU, ...) → X633L/B21 of the battery
voltage defective.
F03 Battery Test circuit on PCB LP 639 defective.

– Test level incorrect (TESTBATT, X634R/C23) → X639/A10, no
12 V pulse (100 milliseconds).
– Power supply unit PCB LP639 SI5 or fuse (in 4008 B/S) in the base
defective.
– R39 on PCB LP639 (4008 H) or PCB LP647 (4008 B/S) defective,
possibly caused by flickering power supply unit.
F95 Battery System error

 Blood leak test
Test description Test of the blood leak detector by lowering the capacity of the
transmitting diode.
Illustration
Display
board
LP 649
(4008 B)
LP 924 LP 922
(4008 H) (4008 S)

Error description
F01 Blood leak Blood leak channel and dimness not in alarm-free condition during the
T1 test.
– Dimness channel contaminated (calcium precipitate, etc.)
– Acknowledgment (BLL, X637/A18) → X633L/B10, voltage value
within the alarm tolerances (< 3 V).
– Acknowledgment (BLL_DIM, X637A/21) → X633L/B11, voltage
value within the alarm tolerances (< 1.5 V / > 8 V).
– DAC_BLL or DAC_DIM not within the tolerances (check
calibration).
F02 Blood leak Blood leak alarm / dimness alarm not detected in case of test
detuning.
not within the alarm tolerances.
value not within the alarm tolerances (< 1.5 V).
– Test detuning (BLL_DET, X632/A25) → X633L/B27, 5 V missing.
– Calibration of DAC_BLL or DAC_DIM is too high.
– Detuning (DAC_DIM, X634R/A11) → X633L/C3 not possible.
– Dimness calibration is set to potentiometer calibration (BR6 from
pos. 1/2 to 2/3).
F03 Blood leak After test detuning, the blood leak channel and dimness fail to enter
the alarm-free state.
– Dimness channel contaminated (calcium precipitate, etc.)
within the alarm tolerances.
– Test detuning (BLL_DET, X632/A25) → X633L/B27, 0 V missing.
value within the alarm tolerances (< 1.5 V / > 8 V).
– DAC_BLL or DAC_DIM not within the tolerances (check
calibration).
F95 Blood leak System error

 Temperature test
Test description Test of the upper alarm limit by electronically detuning the temperature
display in positive direction.
Illustration
LP 639
(4008H)
LP 632 X632/A26 HOTRINSE
CPU 2 X632/A24 T_DIAL1

Logic
LP 647
X632/A23 T_DETADJ (4008S/B)
X633R/C21 X633L/B16
X633R/ X634R/
X632/B27 X632/B28 LP 633 A20 A13
LP 634
Input BIBAG_TE Output
board board
X633R/C25
X633R/C15
X634R/C24
X631/A20 X631/A21
LP 631
LP 630 DATA BUS
CPU 1
Mother
board
MON_NTC
NTC_BIB
X639/A20
LP 639
(4008H)
Display
board Power
LP 649 Logic
(4008 B) LP 647
LP 924 LP 922 (4008S/B)
(4008 H) (4008 S)

Error description
F01 Temperature The temperature measuring range is not set to dialysis.

0 V missing.
F02 Temperature The actual temperature is less than 35.0 °C (test running time
> 15 minutes).
– Calibrate the temperature.
– The heater rod has failed.
– Acknowledgment (T_DIAL1, X633L/B16) → X632/A24, voltage
stuck.
F03 Temperature The actual temperature is higher than 39.0 °C (test running time
> 15 minutes).
– Calibrate the temperature.
– The regulating sensor (NTC-2) is defective.
– Acknowledgment (T_DIAL1, X633L/B16) → X632/A24, voltage
stuck.
F04 Temperature The temperature failed to stabilize within 15 minutes.

– Acknowledgment (T_DIAL1, X633L/B16) → X632/A24
continuously changing (change > 0.3 °C/15 s).
F05 Temperature Detuning in positive direction not more than 3 °C (10 seconds).
– Acknowledgment (T_DIAL1, X633L/B16) → X632/A24, insufficient
change in voltage.
– Detuning (T_DETADJ, X632/A23) → X633R/C21 insufficient.
F06 Temperature The monitor sensor indicates a constant value.

– NTC-3 defective.
F07 Temperature No test release (max. test running time 10 minutes).

– Runtime problem (software).
F08 Temperature CPU1 failed to transmit a bibag® status message within 3 seconds.
F09 Temperature bibag® NTC_BIB detuning not more than 1 °C.

– Acknowledgment (NTC_BIB, X633R/C15) → ADW on PCB LP 633
insufficient voltage change.
– Detuning (BIBAG_TE, X634R/A13) → X633R/A20 insufficient.
F10 Temperature bibag® Temperature display out of measuring range (15–45 °C).
– Acknowledgment (NTC_BIB, X633R/C15) → ADW on PCB LP
633.
F95 Temperature System error

 Negative pressure holding test
Test description: Within a specific time period, the actual value of the dialysate pressure
transducer should change within certain limits only.
Illustration
X632/A19 ACKN_ASP
LP 632
X632/B22 CI
CPU 2
X632/C27 UF_P_CTL
X632/A29 P_DIAL
X632/B27 X632/B28 X633L/B6 X634R/A24 X634R/A23
LP 633 LP 634
Input Output X634L/B10
board board
X633R/C28 X634R/A24
X631/A20 X631/A21
LP 631
Mother
board
UF_P_CTL
+P_DIAL
Display
board
LP 649
(4008 B)
LP 924 LP 922
(4008 H) (4008 S)

Error description
F01 neg. Pressure During the start phase, a negative pressure of more than 450 mmHg
was set (max. test running time 120 seconds).
– Hydraulic system contaminated.
– Air separation pump started.
F02 neg. Pressure The dialysate pressure could not be set to the test pressure
(–300 mmHg to –450 mmHg) (max. test running time 120 seconds).
On repeating the measurement, the range was extended from
–260 mmHg to –490 mmHg.
– Leakage in the hydraulic system.
– UF pump defective.
– If the HDF filter test was skipped: Clamp the HDF Filter
F03 neg. Pressure The working point (116 digits) of the differential amplifier cannot be set
correctly (max. test running time 120 seconds).
– Pressure fluctuations are too large.
– The D-A converter (IC11) on PCB LP632 is defective.
– The operational amplifier (IC1/IC3) on PCB LP 632 is defective.
– Acknowledgment (P_DIAL, X633L/B6) → X632/A29 is defective.
– No CI signal (PCB LP 632 → X632/B22).
F04 neg. Pressure Pressure measurement could not be completed (max. test running
time 120 seconds).
F05 neg. Pressure The air separation pump started running during the measurement
phase.
– Acknowledgment (ACKN_ASP, X634L/B10) → X632/A19,
0 V missing.
– ASP has been interrupted electrically.
F06 neg. Pressure Negative pressure holding test failed. The dialysate pressure drop
exceeds ±40 mmHg (related to ten balancing chamber switchings).
F07 neg. Pressure No current rise pulses detected (min. 2 x).

– No 5 V balancing chamber pulses (CI, X634R/A23) → X632/B22.
F95 neg. Pressure System error
In devices with HDF option, the negative pressure holding test is performed internally only; i.e., V24, V24B
are closed and V26 is open.

 Positive pressure holding test
Test description Valves V24, V24B, and V26 are checked for proper function
(mechanical).
Test of the TMP unit by detuning it electronically in positive direction.
With the dialysate flow turned off, positive pressure is applied to the
balancing system. The actual value of the dialysate pressure transducer
is now monitored for a defined period of time.
Test the pump segment of P97.
Illustration
Display
board
LP 649
(4008 B)
LP 924 LP 922
(4008 H) (4008 S)

Error description
F01 pos. Pressure The mandatory filling program of CPU1 has not been completed
(10 seconds).
– The solenoid valve V43 is not closed.
F24 pos. Pressure V24 valves error.

F25 pos. Pressure No pressure increase above 150 mmHg (change in pressure) after
valve switching.
– Control signals of V24 and V24B mistaken for each other.
– Leakage in the external system (shunt interlock, dialysate lines,
etc.)
– If the HDF filter test was skipped: Clamp the HDF Filter
F26 pos. Pressure No pressure compensation after opening of V43 (–125 mmHg to
55 mmHg).
– V24 stuck (mechanically open).
– V43 not open.
– V26 leaking.
F27 pos. Pressure No pressure compensation after opening of V43 (–125 mmHg to
55 mmHg).
– V24 stuck (mechanically open).
– V43 not open.
– V189 (retentate valve) leaking.
F02 pos. Pressure The loading pressure cannot be measured via solenoid valve V26 in
the hydraulic system (P-Dial. < 600 mmHg, 15 seconds).
– Solenoid valve V26 mechanically not open.
– Solenoid valve V43 mechanically not closed.
The balancing chamber is switched to passage during this test
sequence. V24, V24B, and V43 are closed; V26 is open.
F03 pos. Pressure The hydraulic system cannot be deaerated via the solenoid valve V43;
the zero point of –125 to 55 mmHg has not been reached
(15 seconds).
– Solenoid valve V26 mechanically not closed.
– Solenoid valve V43 mechanically not open.
– Zero point outside the –125 to 55 mmHg range.
F04 pos. Pressure The first working point (220 digits) of the differential amplifier cannot
be set.
– Pressure fluctuations are too large.

F05 pos. Pressure Test detuning results in a change in the measuring range of more than
95 mmHg (60 seconds).
– The operational amplifier (IC2) on PCB LP632 is defective.
– Acknowledgment (P_DIAL, X633L/B6) → X632/A29, change in
voltage too large.
– Detuning defective (P_DETADJ, X632/C20) → X633R/C22.
– The balancing chamber valve V36 or V38 (waste water valve) is
leaky.
F06 pos. Pressure Test detuning results in a change in the measuring range of less than
voltage insufficient.
– V26 leaking.
F07 pos. Pressure After test detuning, there is a difference (P Diff. > ±9 mmHg) between
the display and the differential amplifier.
– The voltage divider R23/R9 or the operational amplifier IC2 is
defective.
– The operational amplifier IC1/IC3 is defective.
leaky.
F08 pos. Pressure Test detuning results in a change in the measuring range of more than
– The operational amplifier (IC2) on PCB LP632 is defective.
voltage too large.
F09 pos. Pressure Test detuning results in a change in the measuring range of less than
voltage insufficient.
– Detuning defective (DIAL_DET_ADJ, X632/C20) → X633R/C22.
F10 pos. Pressure The second working point (116 digits) of the differential amplifier
cannot be set correctly.
F11 pos. Pressure Change in the dialysate pressure after closing of the solenoid valve
V43 (zero point change from –20 mmHg to +80 mmHg within
15 seconds).
– The solenoid valve V24B is not closed.
leaky.

F12 pos. Pressure The loading pressure cannot be measured via the solenoid valves V24
and V24B in the hydraulic system (P Dial. < 600 mmHg, 15 seconds).
– Solenoid valve V24 or V24B mechanically not open.
sequence. V43 and V26 are closed; V24 and V24B are open.
F13 pos. Pressure The hydraulic system cannot be deaerated via the solenoid valve V43;
(P-Dial. not equal to –125 to 55 mmHg, 20 seconds).
– V43 not opening electrically or mechanically.
sequence. V24 and V26 are closed; V24B and V43 are open.
F14 pos. Pressure Zero point change after closing of solenoid valve V43 (20 seconds).
Standard: P-Dial. not equal to –125 to 55 mmHg.
HDF option: P-Dial. not equal to –125 to 60 mmHg.
sequence. V24, V26 and V43 are closed; V24B is open.
F15 pos. Pressure The loading pressure is below 780 mmHg ±30 mmHg (10 seconds).
– The loading pressure is too low.
F16 pos. Pressure During the start phase, the pressure dropped below 620 mmHg
(measurement tolerance: ±30 mmHg, max. test running time
120 seconds).
– Major leakage in the hydraulic system.
– The UF pump spring is defective.
– The loading pressure is too low.
– ASP fails to occlude.
– Relief valve (78) or V43 is leaky.
F17 pos. Pressure In the start phase the dialysate pressure could not be reduced below
760 mmHg (measurement tolerance: ±30 mmHg, test running time
120 seconds).
– The loading pressure is too high.
– UF pump defective.
F18 pos. Pressure The working point (116 digits) of the differential amplifier cannot be set
correctly (test running time 120 seconds).
– The pressure variations in the system are too large.
F19 pos. Pressure Pressure measurement could not be completed (max. test running
time 120 seconds).

F20 pos. Pressure Positive pressure holding test failed. While the flow was off, a pressure
drop of more than ±80 mmHg/min was detected in the hydraulic
system.
– The UF pump spring is defective.
– ASP fails to occlude.
– Relief valve leaking.
– V84 leaking.
F21 pos. Pressure The dialysate pressure cannot be set to a value between 460 and
760 mmHg ±30 mmHg (10 seconds).
– The heat exchanger is defective.
– Hydraulic problem.
F22 pos. Pressure The air separation pump is not running during the test phase
(2 seconds).
– Control line (AIR_SEP+/A22) → ASP/… 24 V missing.
– Control line (AIR_SEP–/C22) → ASP/… 0 V missing.
– Acknowledgment (ACKN_ASP, X634L/B10) → X632/A19,
12 V missing.
F23 pos. Pressure Pressure drop in the hydraulic system during the measuring phase
(8 seconds).
Change more than +4 digits or more than –8 digits.
– Leakage in the pump segment of the air separation pump.
– Leakage in the heat exchanger.
voltage too large.
F24–F27 See between F01 and F02
F28 pos. Pressure ASP functional test (running and delivery test)
– ASP tube segment is occluded.
– ASP tube segment has been incorrectly inserted (check direction
of delivery).
– ASP is not running (electrically or mechanically).
– V87 electrically or mechanically closed.
F95 pos. Pressure System error

 UF function test
Test description CPU1 activates the UF pump at a defined rate.

CPU2 checks the UF pump.
CPU2 blocks the control line of the UF pump and checks whether the
UF pump stops.
Check of the UF counter.
The following is additionally applicable with built-in 4008 HDF option:
CPU1 activates the UF pump 2 at a defined rate.
CPU2 checks the hydraulic and the electric function of the UF pump 2.
CPU2 blocks the control line of the UF pump 2 and checks whether it
stops.
Check of the UF2 counter.
Illustration
X632/C7 UF_P2
X632/A7 UF_P1
LP 632
X632/C28 UF_P_EN
CPU 2
X632/C27 UF_P_CTL X634R/A24
X632/B24 UF_P2CTL
X632/A29 P_DIAL
X633L/ X634R/ X634R/
X632/B27 X632/ B6 C11 A22
B28
LP 633 LP 634
Input Output
board board
X633R/ X633L/ X633L/ X634L/ X634L/

C28 C23 C14 A-C24 A-C23
X631/A20 X631/A21
LP 631
.
Mother
board
.
UF_P2 (nur bei 4008 HDF)
UF_P1
+P_DIAL
Display
board
LP 649
(4008 B)
LP 924 LP 922
(4008 H) (4008 S)

Error description
F01 UF Function The pause between the strokes of the UF pump 1 was shorter than
220 milliseconds. Correct volume delivery is not ensured due to too
short a return.
– CPU1 issued too high a pump rate.
F02 UF Function The pulse time for the UF pump 1 is shorter than 180 milliseconds.
Correct volume delivery is not ensured due to too short an emission
time.
– The monoflop on PCB LP634 is defective (IC42/R82/C47).
F03 UF Function The pulse time for the UF pump 1 is longer than 500 milliseconds. A
maximum rate of 5000 ml/h is not possible.
F04 UF Function No activity of the UF pump 1 during the test (5 seconds).

– Acknowledgment (UF_P1, X637/B23) → X632/A7, no LOW
pulses.
– Control line (UF_P1, X634L/ABC23) → X637/B23, no LOW pulses.
F05 UF Function UF pump 1 cannot be stopped by CPU2.

– Control line (UF_P_EN, X632/C28) → X634R/A22, 5 V missing.
– The reset input at IC42/pin 3 on PCB LP 634 is defective.
F06 UF Function UF pump acknowledgment of CPU1 is defective.

– Acknowledgment (UF_P1, X637/B23) → X633L/C14, no LOW
pulses.
F07 UF Function The change in pressure after a stroke is less than 20 mmHg.
– The UF pump 1 is mechanically defective.
– Control line (UF_P1_CTL, X632/C27) → X634R/A24, no LOW
pulse.
F09 UF Function Dialysate pressure is outside the measuring range (15 seconds).
– UF pressure transducer defective.
F11 UF Function The pause between the strokes of the UF pump 2 was shorter than
220 milliseconds. Correct volume delivery is not ensured due to too
short a return.
– CPU1 issued too high a pump rate.
F12 UF Function The pulse time for the UF pump 2 is shorter than 180 milliseconds.
Correct volume delivery is not ensured due to too short an emission
time.
F13 UF Function The pulse time for the UF pump 2 is longer than 500 milliseconds. A
maximum rate of 5000 ml/h is not possible.
F14 UF Function No activity of the UF pump 2 during the test (4 seconds).

– Acknowledgment (UF_P2, X637/B26) → X632/C7, no LOW
pulses.
– Control line (UF_P2, X634L/ABC24) → X637/B26, no LOW pulses.

F15 UF Function UF pump 2 cannot be stopped by CPU2.

– Control line (UF_P_EN, X632/C28) → X634R/A22, 5 V missing.
– The reset input at IC42/pin13 on PCB LP 634 is defective.
F16 UF Function UF pump acknowledgment of CPU1 is defective.

– Acknowledgment (UF_P2, X637/B26) → X633L/C23, no LOW
pulses.
F09 UF Function Dialysate pressure is outside the measuring range (15 seconds).
– UF pressure transducer defective.
F17 UF Function The change in pressure after a stroke of the UF pump 2 is less than
20 mmHg.
– The UF pump 2 is mechanically defective.
– Control line (UF_P2_CTL, X632/B24) → X634R/C11, no HIGH
pulse.
F20 UF Function The difference in volume between UF pump 1 and UF pump 2 is higher
than 25% (range of tolerance 15%–35%)
– The stroke volume of UF pump 1 or UF pump 2 has been
misadjusted.
F95 UF Function System error

 Conductivity test
Test description Test of the alarm limits by electronically detuning the conductivity by
+5% or by –5%.
Illustration
X632/A26 HOTRINSE
LP 632
CPU 2 X632/A21 COND_DET
X632/A22 COND_SIG
7b
X632/B27 X632/B28 X633L/B8 X633L/B31 X634R/C24
LP 633 LP 634
X633R/A16
Input Output
board baord
X633R/
C17
X633R/C27
X631/A20 X631/A21
LP 631
Mother
board
COND_C108
COND_BIB
COND_C1
Display
board (Bibag-LF-Zelle)
LP 649
(4008 B)
LP 924 LP 922
(4008 H) (4008 S)

Error description
F01 Conductivity The conductivity failed to reach the scale limits or to stabilize within
10 minutes (±0.1 mS/10 sec).
– No concentrate connected.
– Acknowledgment (COND_SIG, X633L/B8) → X632/A22, voltage
outside the measuring range or unstable.
F02 Conductivity Detuning in positive direction not more than 0.5 mS (10 seconds).
– Acknowledgment (COND_SIG, X633L/B8) → X632/A22
insufficient.
– Detuning (COND_DET, X632/A21) → X633L/B31 insufficient.
F03 Conductivity Detuning in negative direction not more than 0.5 mS (10 seconds).
– Acknowledgment (COND_SIG, X633L/B8) → X632/A22
insufficient.
F04 Conductivity The conductivity cell indicates a constant value.

– Conductivity cell defective.
F05 Conductivity CPU1 failed to transmit a bibag® status message within 3 seconds.
F08 Conductivity CPU1 cannot increase the working point (with conductivity
< 40 mS/cm uncompensated) for the bibag® conductivity by > 5 digits
– Detuning (HOT_RINSE, X634R/C24) → X633R/A16,
12 V missing.
– PCB LP633 T2 or IC26 defective.
F06 Conductivity The bibag® conductivity is not more than 1 mS/cm.

– Acknowledgment (COND_SIGNAL3, X633R/A12) → MP TP3 on
PCB LP 633 voltage change insufficient.
F07 Conductivity The bibag® conductivity is outside of the measuring range.

– Acknowledgment (COND_SIGNAL3, X633R/A12) → MP TP3 on
PCB LP633.
– Conductivity outside the expected detuning range caused by
wrong concentrate on the bicarbonate port or temperature too low.
F95 Conductivity System error

 Diasafe / HDF Filter test
Test description Test of the filters by testing the volume of the internal capillary and
pressure holding test.
Illustration
X632/B5 V_DSAFE
X632/C25 V24_EN
X632/C26 V24B_EN
LP 632
CPU 2 X632/A6 V26
X634R/A18
X 6 3 4 R /C 2 2
X632/A29 P_DIAL
X633L/
X632/B27 X632/B28 B6
X634L/A-C28
LP 633 LP 634
X634L/C5
Input Output
.
X634L/C7
board board
.
X634L/A7
X634L/C25
X633R/
C28
X634L/
X634L/
A-C23
A-C30
X631/A20 X631/A21
LP 631
Mother
board
DEGAS+P1
V112
FLOW+P1
+P_DIAL
V36
UF_P1
V35
V26
Display V32
board
LP 649
(4008 B)
LP 924 LP 922
(4008 H) (4008 S)
V26
V35
V35 V36

Error description
F02 Diasafe CPU1 failed to stop the balancing chamber (24 seconds).
– The message via the serial interface from CPU1 to CPU2 is
missing.
– The current rise pulse is missing (CI, X634R/A23) → X633L/C31,
5 V pulse missing.
F04 Diasafe CPU1 failed to complete one balancing chamber switching within
20 sec (30 ml fluid not removed?).
missing.
– The current rise pulse is missing (CI, 634R/A23) → 633L/C31,
5 V pulse missing.
F06 Diasafe During the pressure build-up phase, a negative pressure of less than
–450 mmHg has developed (24 seconds).
– Diasafe valve is not open, control line (V_DSAFE, X632/B5) →
X637/C16, 0 V missing.
F07 Diasafe After the maximum fluid volume of 145 ml + 30 ml has been removed,
the expected negative pressure of –300 mmHg to –450 mmHg failed
to build up.
– Major leakage in the Diasafe filter membrane and/or filter housing.
– Major leakage in the O-rings on filter holder / couplings.
– V26 electrically or mechanically not closed.
F08 Diasafe The negative test pressure of more than –300 mmHg has developed
before the minimum fluid removal of 145 ml –30 ml has been
achieved.
– Diasafe filter contaminated.
– The Diasafe filter was not correctly deaerated at the start of the
test.
– V112 electrically or mechanically not open.
F09 Diasafe The zero point for pressure measurement cannot be set. The
maximum test time has been exceeded (max. test time 5 min).
– Leakage in the Diasafe filter membrane and/or filter housing.
– Leakage in the O-rings on filter holder / couplings.
– PCB LP632, IC3/pin12 not in socket or IC defective (differential
amplifier).
F10 Diasafe The negative pressure to be achieved in the test failed to stabilize
within the maximum test time of 5 minutes
(change > ±16.7 mmHg/min).
– Leakage in the Diasafe filter membrane and/or filter housing.
– V 26 electrically or mechanically not closed.
F20 Diasafe It was not possible to prime (deaerate) the dialysate filter within
2 minutes.
– Flow problems.
– The fill program is permanently active (level sensor, osmosis
water, or PCB LP633, IC36 defective).

F95 Diasafe System error
F01 HDF Filter Diasafe option has not been set although the ONLINE HDF has been
selected.
– On CPU2, the DIP switch array 2, switch 1 is not set to ON.
F02 HDF Filter CPU1 failed to stop the balancing chamber (24 seconds).
missing.
– The current rise pulse is missing (CI, X634/A23) → X633L/C31,
5 V pulse missing.
F04 HDF Filter CPU1 failed to complete one balancing chamber switching within
20 sec (30 ml fluid not removed?).
missing.
– Verify the current rise pulse.
F06 HDF Filter During the pressure build-up phase, a negative pressure of less than
–370 mmHg has developed (24 seconds).
– The HDF filter is clamped/clogged.
– Diasafe valve is not open, control line (V_DSAFE, X632/B5) →
X637/C16, 0 V missing.
F07 HDF Filter After the maximum fluid volume of 255 ml + 60 ml has been removed,
the expected negative pressure of –220 mmHg–370 mmHg failed to
develop.
– Major leakage in the Diasafe / HDF filter membrane and/or filter
housing.
– Major leakage in the O-rings on filter holder / couplings.
F08 HDF Filter The negative test pressure of less than –220 mmHg has developed
before the minimum fluid removal of 255 ml–60 ml has been achieved.
– Diasafe / HDF filters are contaminated.
– The Diasafe/HDF filters were not correctly deaerated at the start of
the test.
– V112 electrically or mechanically not open.
F09 HDF Filter The zero point for pressure measurement cannot be set. The
maximum test time has been exceeded (10 minutes).
– Leakage in the Diasafe / HDF filter membrane and/or filter housing.
F10 HDF Filter The negative pressure to be achieved in the test failed to stabilize
within the maximum test time of 10 minutes
(change > ±13.3 mmHg/min).
– Leakage in the Diasafe / HDF filter membrane and/or filter housing.

F20 HDF Filter It was not possible to prime (deaerate) the Diasafe filter within
2 minutes.
– Flow problems.
– The fill program is permanently active (level sensor, osmosis
water, or PCB LP633, IC36 defective).
F21 HDF Filter It was not possible to correctly rinse / prime the HDF filter within
5 minutes (before the test).
– Flow problems.
– No conductivity
– Conductivity at the upper or lower end of the scale range.
– The HDF pump has stopped (e.g. cover is open).
– The delivery rate of the HDF pump is less than 380 ml/min.
– Tube diameter not set to 8 mm.
– NTC6 permanently fails to detect fluid.
– Sieve on V43 clogged.
F22 HDF Filter It was not possible to correctly rinse / prime the HDF filter within
5 minutes (after the test).
– Flow problems.
– No conductivity
– Conductivity at the upper or lower end of the scale range.
– Particularly for bibag® devices: Check the filter on V43.
– The HDF pump has stopped (e.g. cover is open).
– The delivery rate of the HDF pump is less than 380 ml/min.
– Tube diameter not set to 8 mm.
– NTC6 permanently fails to detect fluid.
– Sieve on V43 clogged.
F95 HDF Filter System error

 Online plus / Diasafe plus filter / HPU test
Error description
F01 ONLINE plus Available options and DIP switch settings do not match.
F01 DIASAFE plus CPU1 system status (MST), HPU status, and DIP switch / Array2
F01 HPU changed during the test running time.
– ONLINEplus™:
CPU2: Array2, DipSw2 not set to OFF
CPU2: Array2, DipSw3 not set to ON
– DIASAFE® plus:
– MST transmitted by CPU1 not matching with the set DIP switch of
array2
– Dip switch/Array2 changed while the test was in progress
– HPU logged off
F34 ONLINE plus Pressure holding test failed. Max. number of treatments exceeded?
F34 DIASAFE plus – Diasafe and HDF filter membranes leaking / worn.
F02 ONLINE plus Dialysate outlet pressure (DA1) outside the permissible ranges
F02 DIASAFE plus (10 seconds). Test range for DA1 –125 mmHg ≤ P_dial ≤ 55 mmHg
F02 HPU – Acknowledgment DA 1 (P_DIAL, X633L/B6) → X632/A29
– Acknowledgment line DA 2 (see Chapter 9.4 on page 9-4)
F03 ONLINE plus Cross-comparison of both pressure transducers (DA1 / DA2) is

F03 DIASAFE plus outside the acceptable tolerance (10 seconds).
F03 HPU P(DA2) == P(DA1) ±20 mmHg
– Acknowledgment DA 1 (P_DIAL, X633L/B6) → X632/A29
– Acknowledgment line DA 2 (see Chapter 9.4 on page 9-4)
F41 ONLINE plus Test valve V183 leaking. Pressure increase in the system ΔP(DA2)
F41 DIASAFE plus > 30 mmHg within 4 seconds
F41 HPU – V183 open, contaminated, or mechanically defective
– HPU, output stage, etc., defective
F42 ONLINE plus No pressure increase of ΔP(DA2) > 200 mmHg within 4 seconds after
F42 DIASAFE plus opening test valve V183 in the system.
F42 HPU – V183 fails to open or mechanically defective
– Air pump defective, is not running
– HPU, V183, and/or air pump output stage, etc., defective
F43 ONLINE plus Lower pressure test range of ΔP(DA2) > 300 mmHg not achieved
F43 DIASAFE plus within 1 second after closing test valve V183.
F43 HPU – HPU, output stage, etc., defective
– Online filter leaking
F44 ONLINE plus The upper pressure test range of ΔP(DA2) 750 mmHg was exceeded
F44 DIASAFE plus within 4 seconds after closing of test valve V183.
F44 HPU – HPU, output stage, etc., defective
F04 ONLINE plus The air pump is running although valve V43 is closed.
F04 DIASAFE plus – HPU, output stage, etc., defective

F05 ONLINE plus Door on the Online Sys module open during the rate test.
– Close the module door.
F06 ONLINE plus Port 1 open during the first pressure build-up phase.
– Close port 1 (substituate port).
F07 ONLINE plus Port 2 open during the first pressure build-up phase.
– Close port 2 (rinse port).
F08 ONLINE plus Failure to reach the test pressure PDIAL2 > 795 mmHg within
12 seconds.
– Calibrate dialysate pressure.
– Replace DA 2 (re-calibration required)
– Air pump (185) or test valve (V183) defective
– Hydraulic system or valve ONL3 (191) leaking
– Air pump control (185) based on V43 status defective
(HPU defective)
F09 ONLINE plus ONLINE system pump failed to comply with the first test rate of
100 ml/min ±9 ml/min.
– ONLINE system pump control defective
F10 ONLINE plus Monitoring unit (Hall sensor) of the pump rotor detects incorrect
rotation of the rotor (desired rate 300 ml/min ±25%).
– ONLINE system pump control defective (outside the tolerance of
±25%)
– Hall sensor / electronics defective
F11 ONLINE plus ONLINE system pump failed to comply with the second test rate of
300 ml/min ±9 ml/min.
– ONLINE system pump control defective
F12 ONLINE plus After the ONLINE system pump was switched off in the test, the
monitoring unit (Hall sensor) detects that the rotor failed to stop
correctly.
– Pump stop (output stage) defective
F13 ONLINE plus After the ONLINE system pump was switched off in the test, the
module detects an actual rate > 0 ml/min.
– Pump stop (output stage) defective
– Rotary transducer electronics defective
F14 ONLINE plus After activation of the substituate pump, the monitoring unit (Hall
sensor) of the pump rotor detects incorrect rotation of the rotor
(desired rate 300 ml/min).
– Pump control defective (outside the tolerance of ±25%)
F15 ONLINE plus After activation of the substituate pump, the system pump failed to
comply with the test rate of 300 ml/min ±9 ml/min.
– Pump control defective
F16 ONLINE plus Port 1 open during ONL valve test sequence.
– Close port 1 (substituate port).

F17 ONLINE plus Port 2 open during ONL valve test sequence.
– Close port 2 (rinse port).
F18 ONLINE plus Acknowledgment of ONL1 (V193) differs from the desired state of the
valve.
– Valve control in the ONLINE Sys module defective
– Valve acknowledgment in the ONLINE Sys module defective
valve.
valve.
F21 ONLINE plus Leakage test ONL3 (V191) not passed.

The permitted pressure drop of ΔP < –10 mmHg has been exceeded
or the test pressure is P ≤ 710 mmHg.
– Valve ONL3 (V191) in the ONLINE Sys module leaking
– Leaky system / tubing connections
– Port1 or 2 in the ONLINE Sys module leaking

– Port 1 in the ONLINE Sys module leaking

F24 ONLINE plus After the valves ONL1 to 3 were opened, the pressure drop in the
system was insufficient (DP < –100 mmHg).
– Valve ONL1 / ONL2 / ONL3 electrically or mechanically not open
– Kinked tubing
– HDF filter strongly contaminated
F25 ONLINE plus No pressure change of ΔP > 40 mmHg within 15 seconds

– HDF filter membrane leaking (major leakage)
– No HDF filter installed
F26 ONLINE plus Insufficient test pressure (P < 750 mmHg) in the system.
F26 DIASAFE plus – HDF filter membrane leaking (major leakage)
– No HDF filter installed
– Hydraulic system leaking

F27 ONLINE plus After the valve V189 was opened, the pressure drop in the system was
F27 DIASAFE plus insufficient (ΔP < –70 mmHg).
– Valve V189 electrically or mechanically not open
– Diasafe filter strongly contaminated
– Filter before/after V43 strongly contaminated
F28 ONLINE plus No pressure increase in the system above P > 760 mmHg.
F28 DIASAFE plus – Diasafe filter membrane leaking (major leakage)
– No Diasafe filter installed
F29 ONLINE plus Pressure holding test failed. Pressure drop within a measurement time
F29 DIASAFE plus of 30 seconds (ΔP > –10 mmHg) excessive.
– Diasafe and/or HDF filter membrane leaking
F30 ONLINE plus During the pressure holding test valve(s) ONL1, 2 or 3 and/or V189
F30 DIASAFE plus was (were) closed (according to electronic acknowledgment).
– Valve control failed
F31 ONLINE plus Fill phase stopped.

F31 DIASAFE plus Valve(s) V26 open and/or V24, V24b closed (according to electronic
F31 HPU acknowledgment), or failure to perform 25 or 15 balancing chamber
switchings within 120 seconds.
– No balancing chamber switching (e.g., only intrinsic clock pulse)
F32 ONLINE plus Valve(s) ONL1, 2, or 3 closed and/or V24 open, or port 1 or 2 open
during the rinse phase (according to electronic acknowledgment).
– Operator opened ports too early.
F33 ONLINE plus Rinse phase aborted.

Valve V189 open (according to electronic acknowledgment), or failure
to perform 34 balancing chamber switchings within 240 seconds.
– Failure to detect current rise pulse
– Conductivity not within the scale range; possible cause:
Concentrate and/or bicarbonate level sensor do not recognize
conductivity, although present
F34 ONLINE plus See between F01 and F02 ONLINE plus / DIASAFE plus
F34 DIASAFE plus
F41 DIASAFE plus
F42 DIASAFE plus
F43 DIASAFE plus
F44 DIASAFE plus
F95 ONLINE plus System error

F95 DIASAFE plus
F95 HPU

2.1.4 Description of device errors during the cleaning programs
 V84 monitoring
Error description
Rinse Failure F01 End of the rinse-free program in Dis I to V.

Conductivity has been recognized via V84, although the valve is still
closed.
This error message can be acknowledged by pressing the Rinse key.
Rinse Failure F21 Disinfectant suction phase in Dis I to IV.

Maximum permissible UF pump strokes (160) during the suction
phase exceeded.
This error message cannot be acknowledged.
Switch the device off and on again.
Rinse Failure F02 Disinfectant suction phase in Dis I to IV.

Conductivity has not been recognized via V84, and the Disinfectant
empty ? message has been acknowledged twice.
Program Dis V (only on devices with HPU)
No conductivity detected via concentrate level sensor, and
Disinfectant empty ? message acknowledged twice.
Rinse Failure F03 End of suction phase in Dis I to IV.

Conductivity has been recognized via V84, although the valve is
already closed.
This error message can be acknowledged by pressing the
Disinfection key.
Rinse Failure F04 End of suction phase in Dis I to IV.

The float switch does not recognize any fluid after the disinfectant has
been drawn in.
Aeration of the disinfectant container!
F01, F02 and F03 cause the V84 monitoring flag to be set. This means after one of these error messages
has occurred Bergström or sequ. dialysis is no longer possible, since it is not possible to switch the flow
off. The V84 malfunction can be eliminated by correctly performing Dis I–IV. Another possible method of
eliminating the malfunction is to use the calibration program (to be performed by a service technician only)
under the NOVRAM menu item (Delete V84 faultiness).

 PSW (pressure switch) monitoring during free rinse program (only with devices with CDS)
The following – DIP switch 8 DIP array 2 on PCB LP631 must be switched to ON.
requirements must be – Free rinse followed by disinfection or hot disinfection (Dis I–V)
fulfilled to run the PSW test or
Mandatory rinse as individual program
START
PSW 104 No Error message Rinse Failure

closed or PSW 102 F13
closed
No V104 opens
PSW 104 open
Pressure reduction by
membrane pumps Yes
Yes
No Error message Rinse Failure

PSW 104 closed
F07
No V102 opens
PSW 102 open Pressure reduction by
membrane pumps Yes
Yes
No Error message Rinse Failure

PSW 102 closed
F08
Error message
Rinse Failure F05 to Rinse
PSW 104 No Failure F06 or Rinse
and
Failure F12
PSW 102 open Yes
(PSW 104 and PSW102
closed) System stopped
PSW
Yes Start monitoring
Pressure reduction in the
Yes rinse chambers (3 strokes
Mandatory rinse each by conc. and bic.
Pressure build-up required pump)
V91/104 open
V100 closed
No
Evacuation of conc. and bic.

line (12 strokes each by
conc. and bic. pump)
Yes Pressure build-up
PSW 104 closed
V91/104 open
V100 closed
No
Pressure build-up 24 V switched off, system

V91/100/102 open stopped
PSW 102 closed Yes Pressure build-up

V91/100/102 open
No
The pressure switches are designed as make contacts.

Specifications
Delta pressure switch Switching point 700 mbar ±20 mbar
Alcatel SEL pressure switch Switching range 675–805 mbar
Envec pressure switch Switching range 700 mbar ±20 mbar

Error description
Rinse Failure F05 Free rinse program with following Dis, HDIS, or mandatory rinse as
individual program in Dis I–V.
Pressure switch for PSW_104 (S124) (bicarbonate) could not be
opened.
– Pressure on distribution piping > 500 mbar (according to
specification max. 500 mbar permissible). Pressure peaks on
distribution piping: Frequently occurs in distribution pipings with
user points if, e.g., several patients are disconnected
simultaneously and disinfection is started.
– Switching point of pressure switch too low:
Desired value = 700 mbar ± 20 mbar
– Check acknowledgment of pressure switch on PCB LP633:
Bicarbonate: X633L/A19
It was impossible to open the pressure switch for PSW_102 (S123)
(concentrate).
Concentrate: X633L/A20
Rinse Failure F07 Free rinse program, Dis, HDIS, or mandatory rinse in Dis. I–V.
Pressure drop during the monitoring phase on PSW_104 (S124)
(bicarbonate) or pressure build-up impossible.
– Check switching point of pressure switch.
– Check loading pressure.
(Possibly splinter or contamination in orifice 151; remove tube and
blow through tube from both ends)
– Check negative pressure and orifice (89).
(To do so, remove the tube and purge from both ends)
– Check check valve (118) and filter (120).
– Check CDS valve (104).
– Check CDS path for leaks.
– Cartridge filter upstream of degassing pump clogged or wrong filter
(filter for disinfectant container) installed. Filters can be
distinguished by different adapters.

Rinse Failure F08 Free rinse program, Dis, HDIS, or mandatory rinse in Dis. I–V.
(concentrate) or pressure build-up impossible.
– Check check valve (117) and filter (119).
– Check CDS valve (102).

Rinse Failure F09 5 minutes before the end of the mandatory rinse in Dis I–V.
Pressure switch PSW_104 (S124) (bicarbonate) or PSW_102 (S123)
(concentrate) did not open after pressure reduction.
See Rinse Failure F12.
The pressure switches for PSW_104 (S124) (bicarbonate) and for
PSW_102 (S123) (concentrate) could not be opened.
– Membrane pumps fail to run.
– V 102 or 104 fails to open.
(bicarbonate) and PSW_102 (S123) (concentrate) or pressure
build-up impossible.
– Check check valve (117/118) and filter (119/120).
– Check CDS valve (102/104).
In case of F07, F08 and F13, the DO NOT SWITCH OFF !! message can, in addition, be alternately
displayed.
However, this message is displayed only if a mandatory rinse program is requested, since the concentrate
and bicarbonate lines still have to be emptied before the device is switched off.

 Rinse section test (check of V91, V99, V100)

in devices with Central Delivery System
BiBag Yes V91/100/102/130 open for 900 ms

Mandatory rinse time No
device? V99 closed
≤3 min
Yes No
V102 is opened for 900 ms, Message V130 Failure,

pressure reduction with Yes PSW_102 No
system stopped
membrane pump Open
(completed for
two bc-switchings)
HPU installed? Yes V91/100/102/188 open for 900 ms

V99 closed
PSW_102 open No Rinse Failure F11, system No

stopped
Message V188 Failure,

Yes PSW_102 No
system stopped
Yes Open
Pressure build-up, PSW_102 Normal mandatory rinse

V91/100/102 open for 900 ms sequence
V99/104 closed, concentrate and
bicarbonate pump stopped
No Message V91/100 Failure,

PSW_102 closed system stopped
Yes
Pressure reduction on PSW_102

V102/104 open for 900 ms, V91/99/100
closed, pressure decreased with
concentrate pump
V91/99/100/102
open for 900 ms, V104 closed
Message V99 Failure,

PSW_102 open No system stopped
Yes

Error description
The pressure switch PSW_102 (S123) (concentrate) did not open
after pressure reduction.
– Membrane pumps fail to run.
– V102 fails to open electrically or mechanically
X633L/A20
V91/V100 Failure 3 minutes before the end of the mandatory rinse in Dis I–V.
V91 or V100 cannot be opened.
– V91 or V100 fail to open electrically: PCB LP634:
V91 = X634L/A12; V100 = X634L/C13
– V91 or V100 mechanically not open: Check sieve (148) upstream
of V100, or valves clogged.
– V99 constantly open (electrically PCB LP 634: X634L/B12 or
mechanically)
– V102 not open
– Pressure switch for PSW_102 (S123) fails to switch.
V99 Failure 3 minutes before the end of the mandatory rinse in Dis I–V.
V99 cannot be opened.
– V99 fails to open electrically:
PCB LP634: X634L/B12
– V99 fails to open mechanically:
Check sieve (149) upstream of V99, or V99 clogged.
– Pressure switch for PSW_102 (S123) fails to open.
V130 cannot be opened (only in devices with bibag®).
– V130 electrically defective:
PCB LP634: X634L/A4
– V130 mechanically defective or clogged
– Check tubing for bicarbonate suction line and bibag block.
V188 Failure V188 cannot be opened.

– V188 electrically defective.
– V188 mechanically defective or clogged
F14 Shortly before the end of the mandatory rinse in Dis I–V.
Rinse section test not completed correctly. Possibly caused by flow
problems.

 Rinse section test (check of V91 and valve 98)

in devices without Central Delivery System
Error description
F14 3 minutes before the end of the mandatory rinse in Dis I–V.
Flow could not be adjusted to 750 ml/min ±50 ml/min. V91 defective.
After V91 has opened, a flow > 950 ml/min failed to develop. V91 or
valve V98 defective.
F14 Shortly before the end of the mandatory rinse in Dis I–V.
problems.

 Rinse section test (check of V91, V99, V100, V130)

in devices with bibag® and without Central Delivery System
The following conditions must be fulfilled for carrying out the rinse
section test:
1. The test is run during the last 3 minutes of the mandatory rinse
program only.
2. DIP switch 7 Dip array 2 on PCB LP631 must be set to ON.
No
Mandatory rinse V100 Failure,
time No
Pressure switch program stop
≤3 min open
Yes
Yes
Pressure reduction
Pressure build-up,
using BIC pump
V91/V100 open
(completed 5 times)
No
Rinse Failure F15, Rinse Failure F16,
Pressure switch No
program stop Pressure switch program stop
open
closed
Yes
Yes
Pressure build-up Pressure reduction

V91 open via V99
V100 closed
No V91 Failure, program

Pressure switch No V99 Failure, program
stop Pressure switch
closed stop
open
Yes
Yes
Pressure reduction
via V100 through Pressure build-up
concentrate pump Pressure build-up
(completed 8 times) V91 open V91/100 open
V100 closed
Pressure switch No Rinse Failure F17, Pressure switch No Rinse Failure F20,
closed program stop closed program stop
Yes
Pressure reduction Pressure reduction

via V130 via V188
No V130 Failure, program V188 Failure, program

Pressure switch Pressure switch
stop stop
open open
Yes
HPU installed? Yes
No
Test completed

Error description
Pressure switch (bibag® pressure switch 134) could not be opened at
the beginning of the test.
– Check pressure switch: Switching point: Desired: 130 mbar + 30
– Suction error on bicarbonate pump.
– V91 constantly electrically or mechanically open.
– V99/100 constantly electrically or mechanically closed.
It is impossible to build up pressure on pressure switch
(bibag® pressure switch 134) via V91.
– Pressure switch fails to close mechanically: Check switching point.
– V91 fails to open electrically: PCB LP634: X634L/A12
– V91 fails to open mechanically (possibly clogged)
– V130 electrically not closed: PCB LP634: X634L/A4
– V130 fails to close mechanically (possibly clogged).
– bibag® connector leaking (check O-rings)
– Sealing on the bicarbonate suction tube leaking.
X633L/A8
It is not possible to reduce pressure on pressure switch
(bibag® pressure switch 134) via V100.
– V100 fails to open electrically: PCB LP634: X634L/C13
– V100 fails to open mechanically (possibly clogged)
– Concentrate pump fails to pump.
– Filter (148) clogged.
– Pressure switch fails to open.
Pressure switch (bibag® pressure switch 134) cannot be closed.
V99 or V130 is leaking.
– Sealing on the concentrate suction tube leaking.
– Pressure switch fails to close.
Pressure switch (bibag® pressure switch 134) cannot be opened.
V99 does not open.
– V100 fails to open electrically or mechanically
– V91 electrically or mechanically open
– Filter (149) upstream of V99 clogged

Pressure switch (bibag® pressure switch 134) cannot be closed.
– V130 electrically or mechanically open.
– V100 electrically or mechanically open
Pressure switch (bibag® pressure switch 134) cannot be opened.
– Check tubing for bicarbonate suction line and bibag block.
– Bicarbonate line squeezed at strain relief.
– Narrowing in the reducer on the bibag® connector
Rinse Failure F20 Pressure switch (134) cannot be closed via V91/100
– V130/V188 electrically or mechanically open.
V188 Failure The pressure on pressure switch (134) cannot be reduced via V188.
– Check tubing for carbonate suction line and air separator block.
– Concentrate line squeezed at strain relief.
Rinse Failure F14 Shortly before the end of the mandatory rinse in Dis I–V.
problems.


2-62
Mandatory rinse ≤ 1 min V39 test
Device with BIBAG? Pressure increase? Yes

DAC degassing pump = 200 Yes Test passed
(dav1 + 20 mmHg < dav2)
Clear mandatory rinse, pressure
compensation
Evacuate rinse chambers
No No
Open: V26, V91, V99, V100,
V31, V33, V35, V37;
V39 closed
Pressure increase?
(dav1+50 mmHg < dav2) Yes
Wait 10 seconds
only.
No
Measure for 5 seconds:

Mean pressure value dav1
Fresenius Medical Care

Test failed, pressure
DAC degassing No
pump =200?
compensation, "V39 Failure"
V39 open;
Wait 5 seconds
Yes
Measure for 5 seconds:

DAC degassing pump = 220
Mean pressure value dav2
4008 B / 4008 H / 4008 S

TM-EN
The following requirements must be fulfilled to run the V39 test:
2. Dip switch 5 Dip array 2 on PCB LP632 must be set to OFF.

1. The test is run during the last minute of the mandatory rinse program
12A-2016
Error description
V39 Failure Upon opening V39, a difference in pressure is detected on the

dialysate pressure transducer (182) (average value V39 open;
average value V39 closed):
Standard device: < 50 mmHg
bibag® device: < 20 mmHg
– V39 fails to open or close electrically or mechanically (possible
fault in hydraulic processing unit).
– It is impossible to re-adjust the degassing pump (PCB LP634).
– V91, V99, V100 fail to open electrically or mechanically.
– Dialysate pressure transducer (182) defective or not calibrated
(possible fault in HPU PCB LP 941)
– Filter 210 (upstream of degassing pump) clogged.

 Further messages which may be displayed before or during a cleaning program
Error description
Blood sensed by OD Start of a cleaning program in RI I–II, HR I–III, Dis I–V.

The optical detector in the level detector module senses blood.
Shunt Cover open Start of a cleaning program or during the course of RI I–II, HR I–III,
Dis I–V.
The shunt interlock is not closed.
Dialines not conn? Start of a cleaning program in RI I–II, HR I–III, Dis I–V.
The dialysate couplings are not connected to the shunt interlock.
No LD alarm Priming of the blood line system in RI I–II, HR I–III, Dis I–V.
The drip chamber in the level detector module does not recognize any
alarm.
Conc line not conn Start of a cleaning program in RI I–II, HR I–III, Dis I–V.
Or end of the disinfectant suction phase in Dis V.
The concentrate plug is not connected to the rinse chamber.
Reconnect the concentrate plug to the rinse chamber.
Bic line not conn Start of a cleaning program in RI I–II, HR I–III, Dis I–V, or end of the
disinfectant suction phase in Dis V.
The bicarbonate plug is not connected to the rinse chamber.
Reconnect the bicarbonate plug to the rinse chamber.
Voltage Failure During a cleaning program in RI I–II, HR I–III, Dis I–V.

The 24 V/12 V supply voltages are drifting.
This error can be acknowledged for 8 seconds by pressing the
respective program key.
CPU2 failed During a cleaning program in RI I–II, HR I–III, Dis I–V.

The watchdog relay has dropped.
Communication (RxD or TxD) may be disturbed.
High temperature During a cleaning program in RI I–II, HR I–III, Dis I–V.

Temperature > 41 °C; > 90 °C during HR; > 91 °C during IHR.
The device continues to run.
The alarm tone can be acknowledged.
Upon error elimination, the message is automatically cleared.
Low temperature During a cleaning program in RI I–II, HR I–III, Dis I–V.

Temperature < 33 °C; < 78.5 °C during HR .
The alarm tone can be acknowledged.
Water alarm During a cleaning program in RI I–II, HR I–III, Dis I–V.

The float switch transmits the "no water available" message for more
than 10 seconds.
The balancing chamber has stopped; V41 is permanently open.

Water alarm During a cleaning program in RI I–II, HR I–III, Dis I–V.

For more than 30 seconds, the float switch fails to signal that water is
required (not applicable to recirculation programs).
Flow alarm During a cleaning program in RI I–II, HR I–III, Dis I–V.

A current rise pulse is not recognized for more than 12 seconds.
The device continues to run in intrinsic clock pulse mode
(10 seconds).
Upper Flow Alarm During a cleaning program in RI I–II, HR I–III, Dis I–V.
The cleaning flow increases to >1000 ml/min. The program has
stopped.
The error can be acknowledged by pressing the respective cleaning
program key.
UF pump failed During a cleaning program in RI I–II, HR I–III, Dis I–V.

The UF pump has stopped or the rate deviates (2800 ml/h < UFR <
6000 ml/h). The program has stopped.
program key.
UF pump2 failed During a cleaning program in RI I–II, HR I–III, Dis I–VI.

UF2 pump has stopped (only in devices with 4008 HDF).
program key.
Dial. Valve failed During a cleaning program in RI I–II, HR I–III, Dis I–V.
V24 or V24b is closed although it should be open.
The program has stopped.
The error message can be acknowledged by pressing the respective
program key.
Bypass Valve failed During a cleaning program in RI I–II, HR I–III, Dis I–V.
V26 is closed although it should be open.
The error message can be acknowledged by pressing the respective
program key.
V102 Failure During a cleaning program in RI I–II, HR I–III, Dis I–V.

V102 has been opened electrically.
24 V are switched off.
The error cannot be acknowledged.
V104 Failure During a cleaning program in RI I–II, HR I–III, Dis I–V.

V104 has been opened electrically.
24 V are switched off.
The error cannot be acknowledged.

HDF-Pump failure During a cleaning program in RI I–II, HR I–III, Dis I–V.

The HDF pump has stopped, or the speed deviates (desired value:
400 ml/min, actual value: ≤ 300 ml/min; desired value: 150 ml/min,
actual value: ≤ 100 ml/min)
The error message can be acknowledged for one complete cleaning
program run by pressing the respective program key. The prompt Are
you sure ? appears.
Float-Switch Failure During a disinfection program in the suction phase in Dis I–V.
The lower switching point of the float switch is not reached within
20 seconds.
Connect Disinfectant Disinfectant suction phase in Dis V.

Request to connect the disinfectant.
Press CONFIRM Key Disinfectant suction phase in Dis V.

After the disinfectant has been connected, the Confirm key on the
menu panel must be pressed to start the suction procedure.
Please Wait Disinfectant suction phase in Dis V.

Disinfectant is drawn in via the concentrate pump.
Disinfectant empty ? Disinfectant suction phase in Dis I–V.

Dis V: After the disinfectant has been drawn in, the float switch does
not recognize any fluid.
Dis I–IV, Dis VI: Monitoring of V84 does not detect any conductivity.
Disinf. Temp. too high Transition to disinfection in Dis I–V.

Temperature at the end of the free rinsing procedure > 40 °C.
The free rinsing procedure is repeatedly prolonged by 1 minute.
An audible warning is sounded after 4 minutes.
The message is automatically cleared, and it cannot be
acknowledged.
Rinse required ! During stored mandatory rinse in Dis I–V.

The mandatory rinse has been interrupted (e.g., the device has been
switched off).
Rinse after Disinf. Selection of a cleaning program when a mandatory rinse is required in
HR.
A disinfection program has been stopped and subsequently a rinsing
or hot rinsing program started.
Power failure During a cleaning program in RI I–II, HR I–III, Dis I–V.

Line voltage failed.

BIBAG cover open At the start of a cleaning program in RI I–II, HR I–III, Dis I–V.
The bibag® connector is not closed (cap not attached).
Heater Failure During the CDS rinsing phase at the end of a hot rinsing program or a
hot disinfection program in CDS: HR I–III, Dis II–IV.
Heating signal (PCB LP 633: X633R/A26) does not change for
> 40 seconds.
Accumulator empty! Battery voltage < 17.2 V ±2.5%

Only in the event of a power failure during the cleaning programs.
If the voltage drops below 17 V, the device will switch off.

2.1.5 Error messages after turning the power on
Error description
EPROM ERROR System error.

Check the plugs and the EPROM for proper connection, replace
EPROM if necessary.
BRAM_#_XXXX_XXXX_XX System error.

XX Switch the device off and on again.
Check the plugs and the BRAM of PCB LP631 and PCB LP632 for
proper connection, replace BRAM if necessary.
Then recalibrate.
RAM ERROR System error.

Check the plugs and the RAM for proper connection, replace RAM if
necessary.
Keyboard Error Short-circuit on the keyboard.

Check the plugs for proper connection. Possible short-circuit on the
keys. Replace the front panel, if necessary.
Watchdog Error This error message can only be displayed shortly after switch-on.
Check the WD relay and components. Check CPU2/CPU1.
Check the plug connectors on the monitor.
XXX (not calibrated) NOVRAM error on test request.

Recalibrate the function indicated, replace NOVRAM if necessary.
NTC 109 switched off No valid value was stored on start-up in the NOVRAM.
The difference in temperature between NTC 109 and NTC 3 is too
large.
Switch off NTC 109 in the setup menu, or recalibrate the temperature.

2.1.6 Error messages during dialysis
Error description
Voltage Failure The 24 V/12 V supply voltages are drifting.

Device switches to safe state and must be turned off for at least
ten seconds at the power switch to disconnect it from the mains
(voltage and current monitoring are reset in the power supply unit).
– The 12 V or 24 V operating voltage is outside of the permissible
range:
24 V: > 26 V / < 22.5 V
12 V: > 13.5–15 V / < 10.5 V
– Check the power supply unit.
– Power supply unit okay: Check the voltages on PCB LP 633:
+12 V: X633R/A, C31
+24 V: 24 V_EM: X633L/B20
24 V Switched Off The 24 V mains power has fallen below 5 V.

Device switches to safe state and must be turned off for at least
ten seconds at the power switch to disconnect it from the mains
(voltage and current monitoring are reset in the power supply unit).
– Check the power supply unit.
– Power supply unit okay: Check the voltages on PCB LP 633:
+24 V_EM: X633L/B20
– Remove all plug-in modules. As soon as the machine is running:
Reconnect each plug-in module individually with the device
switched off; determine the defective module and repair it.
– Fully detach the hydraulics unit connections.
Caution: J1 must now be fitted on PCB LP630 since, without it, the
device would not be able to perform the watchdog test. Be
absolutely sure to remove the jumper again for treatment.
With the system running, check the short circuit in the hydraulic
compartment for 24 V supply and the valves and pumps for short
circuit.
CPU2 failed CPU 2 fails to communicate via the serial interface.

The device enters the safe state and must be switched off / on.
– The software versions of CPU1 and CPU2 are mismatched.
– Hardware defect on CPU 2.
Profile time diff. Deviation in time between CPU1 and CPU2.

The error message is emitted 60 seconds after the start of the profile.
– The clock module on CPU1 (IC 14) is defective; or calibrate the
time in case of layout < D.
Cyclic PHT F01 Balancing error

– System leakage.
– Applicable to Diasafe devices: On CPU2, the DIP switch array 2,
switch 1, is not set to "ON".
Cyclic PHT F02 Balancing error

– System leakage.
– Applicable to Diasafe devices: On CPU2, the DIP switch array 2,
switch 1, is not set to "ON".

Cyclic PHT F03 IC1 or IC3 on PCB LP 632 is defective, or system is leaky.
Cyclic PHT F04 Test could not be completed within a specific time interval.
V84 faultiness Conductivity detected on V84 electrodes.

This error message is emitted for the first time at the end of the T1 test.
The error can be acknowledged for the duration of one dialysis
procedure by pressing the Dialysis Start key. However, it is not
possible to switch off the flow (Bergström / Sequ. dialysis mode).
Should the error occur during Flow OFF, the flow is switched on
automatically.
– First verify whether an F01, F02, or F03 rinse failure occurred
during the last disinfection procedure (see Chapter 2.1.4 on
page 2-50). Should this be the case, a disinfection program I to IV
(not Dis V) must be completed correctly. Another possible method
of eliminating the malfunction is to use the calibration program
under the NOVRAM menu item (Delete V84 faultiness).
– If this is not possible either, the error memory of the device can be
read out.
– If this is not possible either, the test described below can be
performed:
Remove the disinfectant.
Perform or skip the T1 test.
If the error message is displayed again at the end of the test, it was
generated by an F01, F02, or F03 rinse failure and can be cleared
only by taking the measures described above.
If the message is not displayed again, a second test can be
performed:
Reconnect the disinfectant.
Set the UF rate and switch on the UF unit.
Should the error occur at this moment, there is a leakage on V84
(see Chapter 2.1.4 on page 2-50).
Shunt Cover open – PCB LP 633 C24 (100n) short circuits sporadically.
(temporarily) – Shunt interlock defective (check switches).
Voltage Failure PCB LP 633 C84 (100n) short circuits sporadically.

(temporarily)
UF1 volume - Error UF pump test failed. The capacity of the secondary air separator is
UF2 volume - Error outside the tolerance of 100 ml ±4 ml.
Possible causes:
– The affected UF pump fails to deliver correctly (not calibrated or
mechanical defect).
– If the test result is > 104 ml, the cause may stem from air
transported from a poorly deaerated dialyzer.
F327 UF-failure Pause between two UF1 pump strokes less than 220 milliseconds.
Possible causes:
– CPU1 defective.
F328 UF-failure Pulse time of one UF1 pump stroke is less than 180 milliseconds.
Possible causes:
– Controlling monoflop on PCB LP634 defective.

F329 UF-failure Pulse time of one UF1 pump stroke exceeds 500 milliseconds.
Possible causes:
F330 UF-failure Pick-up time of the UF1 pump exceeds 10 seconds.

Possible causes:
– Controlling output stage on PCB LP634 defective.
F331 UF-failure Desired / actual rate of the UF1 pump deviates by more than ±10%.
Possible causes:
– System error
F332 UF-failure UF1 pump stopped for more than the maximum time period.
Possible causes:
– UF pump interruption
– System error
F333 UF-failure Volume changes by more than 10 ml during desired idle time (only
monitored if OD senses blood).
Possible causes:
– System error
F334 UF-failure Pause between two UF2 pump strokes less than 220 milliseconds.
Possible causes:
– CPU1 defective.
F335 UF-failure Pulse time of one UF2 pump stroke is less than 180 milliseconds.
Possible causes:
F336 UF-failure Pulse time of one UF2 pump stroke exceeds 500 milliseconds.
Possible causes:
F337 UF-failure Pick-up time of the UF2 pump exceeds 10 seconds.

Possible causes:
F338 UF-failure Desired / actual rate of the UF2 pump deviates by more than 10%.
Possible causes:
– System error
F339 UF-failure UF2 pump stopped for more than the maximum time period.
Possible causes:
– UF pump interruption
– System error
F340 UF-failure Change in UF2 volume is more than 10 ml despite the UF being
switched off.
Possible causes:
– System error

F341 UF-failure Mechanical UF1 pump failure.

Possible causes:
– Broken spring
– Contaminated sieve
F342 UF-failure Mechanical UF2 pump failure.

Possible causes:
– Broken spring
– Contaminated sieve
F343 UF-failure Difference in volume between UF1 and UF2 pump.

Possible causes:
– Change in delivery volume
F350 UF-failure A difference of more than 100 ml between the CPU1 and the CPU2
volume is detected during a UF data transfer after turning the UF unit
on.
Possible causes:
– System error
F351 UF-failure CPU2 could not detect plausibility of the CPU1 UF parameters.
Possible causes:
– System error
F352 UF-failure CPU2 UF deviation from theoretical UF target volume.

Possible causes:
– System error
F354 UF-failure UF rate exceeds the maximum rate allowed.

Possible causes:
– System error
F361 UF-failure CPU1 sent the UF parameter set to CPU2 and has not received an
enable from CPU2 after a timeout of 30 seconds.
Possible causes:
– System error
F363 UF-failure CPU2 repeatedly did not receive a complete UF parameter set.
Possible causes:
– System error
F364 UF-failure UF1 volume change although the UF goal has already been reached.
Possible causes:
– System error
F370 UF-failure UF2 volume change although the UF goal has already been reached.
Possible causes:
– System error

 HPU Error
Error description
HPU Error F00 The HPU logs off with index STATUS_ER; no bit is set in the error bit
field.
– Problem on PCB LP 941
– Problem on CAN distributor board
HPU Error F01 Cyclic communication has failed for more than 2 seconds.
– System error
HPU Error F02 The response to an event violated the timeout.

– System error
HPU Error F03 An error occurred in the program sequence.

– System error
HPU Error F04 Voltage drop (24 V_SW) during HPU operation.
– 24 V voltage supply on PCB LP 941 failed (watchdog dropped)
HPU Error F05 Watchdog test failed.

– Watchdog circuit on PCB LP941
HPU Error F06 Reference voltage monitoring detected an error.

– Reference voltage circuit on PCB LP 941 is defective.
HPU Error F07 The HPU was logged off by the monitor. Will not be displayed since
CPU1 has already stopped the communication.
– System error
HPU Error F08 General valve error. Can occur in HPU SW 2.01 or 3.00. (Software
versions before evaluation of the HPU errors).
– System error
HPU Error F09 Compressor error (185)

– MV43 defective or activated
– Compressor 185 defective or activated
– Error on PCB LP 941
HPU Error F10 Error in valve MV39

HPU Error F11 Error in test valve (183)

HPU Error F12 Error in evacuation valve (188)

HPU Error F13 Error in retentate valve (189)


HPU Error F14 Component error on PCB LP 941

HPU Error F15 Error in the HPU software. Valves are activated incorrectly.
– System error
HPU Error F98 Transition to the T1 test is not allowed after restart.
– System error
HPU Error F99 HPU fails without logging off.

– Damaged cable or similar problem
– HPU logged off by CPU1
– CRC error in the transfer HPU → CPU1
– BVM is connected via CAN and software < 3.20 is installed in the
BVM.
– Electrical safety check was performed directly after turning on the
device.
Turn the device on at least 2 minutes before the test.

 ONLINE Module Error
Error description
ONL Error F00 ONLINE Module Error
ONL Error F01 Watchdog Error
ONL Error F04 Error in program sequence
ONL Error F05 +24 V_WD dropped to less than 17 V or was switched off
ONL Error F06 Time-out of the communication watchdog exceeded
ONL Error F07 A transmission from the module was not confirmed by the monitor.
ONL Error F08 General valve error
ONL Error F09 T1 Test overridden
ONL Error F10 T1 Test for ONLINEplus™ failed
ONL Error F11 Reference voltage is outside of tolerance
ONL Error F12 CRC error
ONL Error F13 EEPROM error
ONL Error F14 The monitor disabled the ONLINEplus™ module
ONL Error F16 ONL1 valve error

2.2 Functional description of the modules
2.2.1 Blood pump (arterial)
The blood pump ensures a sufficient blood flow in the extracorporeal blood circuit. It is absolutely
necessary that sterility is maintained and that the blood is prevented from becoming contaminated.
The blood pump integrated in the device is a roller pump designed as a field-replaceable plug-in module.
The blood line is inserted between the circular roller track of the pump casing (stator) and the rollers, which
are attached to the rotor. The pressure of the rollers causes the development of a narrowing and seal. If
the rollers are moving in the direction of delivery, the blood is pushed in this direction.
A microprocessor controls the stepper motor with quartz accuracy, depending on the selected delivery
rate, the set tube diameter, and the monitor signals.
The pressure measuring equipment comprises a piezo-resistive pressure transducer. The pressure-
proportional voltage is indicated on the monitor on a quasi-analog LED scale.
Functions of the blood – RAM and CRC test after turning power on
pump – Control and monitoring of the function by a dual-processor system
– Emergency stop in case of alarm: Stop detection (15 or 30 seconds)
– Setting of the speed to 180 ml/min during priming
– Measurement of the arterial pressure or the Single-Needle pressure
(depending on model)
– Semi-automatic loading and unloading of the tube segment
Error messages
E.01 Tube diameter outside the permissible range
E.02 Undefined hex switch position
E.03 Uncalibrated arterial pressure transducer
E.04 Runtime monitoring error in SN mode
E.05 SN stroke volume is outside of the permitted range
E.06 SN pressure thresholds outside the range of values of the

AD converter
E.08 Stop alarm
E.09 Error during AD conversion
E.12 Speed monitoring error (Hall sensor)
E.13 Error monitoring current sensing resistors
E.14 Error monitoring current sensing resistors
E.15 Speed monitoring error

2.2.2 Blood pump (Single Needle), option
Essentially, the blood pump (Single-Needle) is identical with the arterial blood pump. The difference lies
in the Single-Needle control. During SN operation, the pressure outlet of the compliance vessel is
connected to the pressure connector of the SN pump. The pressure transducer is protected by a
hydrophobic filter both in the external and the internal tubing system.
The SN stroke volume can be set within a range from 10 ml to 50 ml in increments of 5 ml.
To set, first press the Start/Stop key and  key simultaneously.

Then change the value by using the  and  keys.
The lower changeover point is fixed to 75 mmHg.
The upper changeover point depends on the stroke volume:
Stroke volume (ml) 10 15 20 25 30 35 40 45 50
Upper switching point 110 130 150 172 195 219 244 270 299
(mmHg) ±7 mmHg

2.2.3 Heparin pump
Since the blood flows through an extracorporeal circuit during hemodialysis, coagulation would occur
within a short time. The heparin pump allows continuous heparinization of the blood causing the
coagulation time to be prolonged. Since the heparin volume required during dialysis depends on the
respective patient concerned, it must be determined by the attending physician.
A syringe plunger is moved by a drive rod. The drive rod is connected to a threaded spindle via a slide. A
microprocessor-controlled stepper motor causes the spindle to rotate. Depending on the activation, the
piston will move up or down. A Hall sensor indicates the upper end position of the plunger. The protective
system of the pump comprises a speed monitoring unit (slotted disc with optical sensor) as well as a motor
current monitoring unit.
Warning
The syringes classified as approved among the syringes indicated
below were successfully tested with the device.
If syringes that are classified as not approved in the table below are
used, it is the responsibility of the responsible operator to ensure correct
function of the device.
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.
Adjusting Syringe type Release as part of overall

the hex approval
switch
0 20 ml BD / Fresenius Approved
1 30 ml Fresenius Not approved
2 50 ml Fresenius Not approved
3 10 ml BD Not approved
6 20 ml Terumo Not approved
9 20 ml JMS Not approved
A 20 ml Nipro Not approved
B 20 ml Weigao Not approved
C Not assigned –

Adjusting Syringe type Release as part of overall

the hex approval
switch
D Not assigned –
E Not assigned –
F Not assigned –
Warning
Do not change the coding switch position during operation.
Function of the heparin – RAM and CRC test after turning power on
pump – Delivery rate adjustable between 0.1 ml and 10 ml in increments of
0.1 ml
– Delivery time selection (stop watch) ranges between 1 min and
9 h 59 min
– Bolus administration
Error codes
E01 Hardware error, gate array defective
E02 Hardware error, reset by spike or test alarm
E03 Checksum error, data loss
E04 First start-up
E05 Incorrect hex switch position
E06 No data or incorrect data for variable syringe
E07 Wrong syringe selected
E11–E13 Step error
E12 Overdelivery during fast return
E14–E15 Error in direction of rotation (software not equal to hardware!)
E16 Software error
E19 Optical sensor error (catch or optical sensor stopper defective)
E20 Error in direction of rotation
E33 Step error (impermissible range)
E37 Slotted disc error
E40 Division error (division by zero)
E41–E42 Error in direction of rotation (fast return)
E43–E44 Error in direction of rotation (slow return)

E45–E46 Error in direction of rotation (fast advance)
E47–E48 Error in direction of rotation (slow advance)
E49 Step error (underdelivery during slow advance)
E50 Step error (underdelivery during slow return)
E51 Step error (overdelivery during fast advance)
E55 Error in step counting (optical sensor defective or mechanics too

sluggish; no pulses from the slotted disc)
E56 Error in step counting (more than 8 pulses during transition of the
slotted disc; the slotted disc is oscillating)
E90 Display error

2.2.4 Level detector
The penetration of air into the patient's extracorporeal blood circuit may cause an air embolism. In order
to catch limited amounts of air and to separate accompanying air bubbles, the venous blood line is
expanded (venous drip chamber). A major task of the level detector is to monitor the filling level in the
venous drip chamber.
Ultrasonic level detector
The protection system against air infusion uses the method of ultrasonic transmission. Ultrasonic
converters are attached on either side of the venous bubble catcher. At periodic intervals of approx.
90 ms, a transmitting resonator generates attenuated ultrasonic vibrations at a natural resonance of
approx. 90 kHz, which are absorbed by a receiving resonator. The amplitude of the signal received is
dependent upon the medium between the converters. Its value is at its minimum with the bubble catcher
empty (air) and at its maximum with bubble-free fluids. The amplitude decreases with increasing air
content (foam). The signal path is fail-safe up to and including the receiving resonator, i.e., the failure of
any component always leads to a smaller amplitude and, thus, to an alarm. Starting at the receiving
resonator, the signal voltage is always sent onto two independent receiver paths. As soon as the signal
is too weak, one of these receiver paths causes the blood pump to stop and the other the venous
occlusion clamp to close.
The  and  keys are used to raise and lower the blood level in the venous bubble catcher. As long as
the  key is pressed, the venous occlusion clamp closes. The vent valve in the level detector module
opens, and the blood level rises. The blood pump runs at reduced speed (180 ml/min). As long as the
 key is pressed, the venous occlusion clamp remains open. The vent valve in the level detector module
opens, the ventilation pump is running, and the blood level sinks. The blood pump runs at the preselected
speed.
Optical detector
The optical detector detects if there is blood, NaCl solution, or air in the venous return tube downstream
of the bubble catcher. In the device, the dialysis phase is defined by presence of a dark medium and the
preparation phase by presence of a clear medium.
Venous pressure measurement
The venous pressure measuring equipment comprises a piezo-resistive pressure sensor provided on the
PCB with following operational amplifier. The pressure-proportional output voltage is supplied onto the
logic PCB in the monitor. There, the pressure is indicated on a quasi-analog LED scale, and the
transmembrane pressure is computed by determining the difference between the dialysate pressure and
the venous pressure.

2.3 Functional description of the hydraulics
Fig.: Flow diagram

Legend
2 Temperature sensor 97 Air separation pump

3 Temperature sensor 98 Rinse valve
4 Temperature sensor (OCM option) 99 Rinse valve
5 Float switch 100 Rinse valve
6 Level sensor 102 Central conc. delivery valve
7 Conductivity cell 104 Central bic. delivery valve
8 Blood leak detector 109 Temperature sensor
9 Pressure transducer 110 Conductivity cell (OCM option)
10 Reed contact for concentrate 111 Hydrophobic filter (advanced hydraulics)
12 Reed contact for bicarbonate 112 Vent valve (advanced hydraulics)
21 Flow pump 114 Dialysate filter (option DIASAFE® plus)
22 UF pump 115 Disinfection valve sensor
23 Concentrate pump 116 Fluid sample valve
24 Dialyzer valve 1 117 Check valve (concentrate)
24b Dialyzer valve 2 118 Check valve (bicarbonate)
25 Bicarbonate pump 119 Filter (concentrate)
26 Bypass valve 120 Filter (bicarbonate)
29 Degassing pump 121 Central conc. delivery connection
30 Outlet valve 122 Central bic. delivery connection
31 Balancing chamber valve 1 123 Pressure switch for V102
33 Balancing chamber valve 3 125 Temperature compensation plate
34 Balancing chamber valve 4 130 bibag® drain valve
35 Balancing chamber valve 5 132 bibag® conductivity cell
36 Balancing chamber valve 6 133 bibag® temperature sensor
37 Balancing chamber valve 7 134 bibag® pressure transducer
38 Balancing chamber valve 8 136 bibag® connector
39 Negative pressure valve 137 bibag® microswitch 1
41 Water inlet valve 138 bibag® microswitch 2
43 Fill valve 148 Filter (rinse valve 100)
54 Heater rod 149 Filter (rinse valve 99)
61 Pressure reducing valve 151 Orifice
63 Filter / water inlet 182 Pressure transducer 2 (advanced hydraulics)
65 Loading pressure valve 183 Test valve (advanced hydraulics)
66 Heater block 184 Hydrophobic filter
66a Water inlet chamber 185 Compressor (advanced hydraulics)
66b Heater rod chamber 188 Evacuation valve
66c Float chamber 189 Retentate valve
68 Balancing chamber 190 Online filter (option ONLINEplus™)
71 Filter / concentrate 191 Online 3 valve (option ONLINEplus™)
72 Filter / bicarbonate 192 Online 2 valve (option ONLINEplus™)
73 Filter / external dialysate 193 Online 1 valve (option ONLINEplus™)
74 Filter / UF 194 Rinse port (option ONLINEplus™)
75 External flow display 195 Substituate port (option ONLINEplus™)
76 Filter / fill valve 201 Air separator / concentrate
77 Heat exchanger 202 Level sensor / concentrate
78 Relief valve 203 Air separator / bicarbonate
84 Disinfectant valve 204 Level sensor / bicarbonate
85 Disinfectant connection 205 Mixing point, concentrate / bicarbonate
86 Recirculation valve 210 Filter (degassing orifice)
87 Drain valve
88 Multifunction block
88a Degassing chamber
88b Secondary air separator
88c Primary air separator
89 Degassing orifice
90a Rinse chamber, concentrate Hydraulics measuring points
90b Rinse chamber, bicarbonate
91 Rinse valve A Reduced water inlet pressure
92 Vent valve B Balancing chamber loading pressure
94 Concentrate suction tube C Flow pump pressure
95 Bicarbonate suction tube D Degassing pressure

2.3.1 Description of the hydraulics unit
As soon as the inlet valve (41) opens, the water flows through the pressure reducing valve (61) into the
chamber (66a) of the heater block and across the heat exchanger (77) into the heater rod chamber (66b).
The concentrate pump (23) admixes concentrate to the inflowing water per balancing chamber phase.
The overflow prevents pressure from building up in chambers b and c. In Hot rinse mode, the developing
vapor can escape through the overflow.
While it is rising, the fluid is warmed up to the preset temperature by the heater (54). The heater is
controlled by the temperature sensor (2).
From chamber b, the dialysate flows into the chamber (66c). Incorporated into this chamber is a float
switch (5), which controls the solenoid valve (41), thus ensuring the correct fluid level.
The degassing pump (29) draws in the dialysate via the degassing orifice (89). This generates a negative
pressure of approximately 0.8 bar.
In the tubes and the following chamber (88a), the dialysate is degassed to a level which is sufficient for
dialysis.
Via the degassing pump (29), dialysate and released air are directed tangentially into the primary air
separator (88c), where air bubbles and the airless dialysate are separated. The air accumulates at the top
of the chamber (88c). Then, together with the recirculation flow and via the loading pressure valve (65) as
well as the chamber (66c), the air escapes into the atmosphere.
Chamber 88c is provided with a separating disc (standard hydraulics only), which serves to prevent
bicarbonate, if added, from being recirculated via the heater rod chamber (66b).
At the bottom of chamber (88c), the degassed dialysate is pressed out and into the balancing
chamber (68) by means of the loading pressure.
Together with the eight solenoid valves (31 to 38), the balancing chamber (68) constitutes the balancing
system. Each of the two sections of the balancing chamber comprises two compartments separated by
an elastic membrane each. Hence, there are two chambers with four spaces:
– F1 and F2: Fresh solution
– A1 and A2: Used solution (waste)
As soon as one of the chambers (A1 or A2) is filled with dialysate, the solenoid valves are reversed in
groups of four. The valves are reversed by the electronic evaluation of the current rise pulse of the drive
motor of the pump (21), which receives this pulse upon membrane abutment. Within the filling phase, F1
or F2 is filled with fresh dialysate by means of the loading pressure. In order to obtain a continuous flow,
a second chamber is switched parallel to the first chamber. The second chamber is operated in an inverse
sequence.
Each time the chamber is changed over (membrane end position), all valves are closed for approximately
100 milliseconds (dead time).
From the balancing chamber, the dialysate flows through the conductivity cell (7) with integrated
temperature sensor (3). The measured conductivity values are indicated on the monitor in ms/cm, related
to 25 °C.

The temperature sensor (3) has the following functions:

– Temperature compensation of the conductivity display
– Indication of the dialysate temperature
If the actual values (temperature or conductivity) of the dialysate exceed or fall below the alarm limits, the
bypass valve (26) opens, and the dialyzer inlet valve (24) is closed. The device is now in the bypass mode.
The dialysate is discharged into the drain not via the dialyzer, but via the secondary air separator (88b)
and the balancing chamber (68).
If the actual conductivity and temperature values of the dialysate are within the set limits, the dialyzer
valve (24) opens. The valve (26) is closed. The dialysate flows to the dialyzer.
After the dialyzer, the dialysate which is now loaded with the substances usually eliminated with the urine
flows into the secondary air separator (88b) via a filter (73), the valve (24b) and the blood leak
detector (8). The secondary air separator (88b) comprises the pressure transducer (9) and the level
sensor (6).
With a hematocrit of 0.25, blood losses of 0.5 ml per minute are recognized in the dialysate by the blood
leak detector.
Together with the venous back pressure, the signal of the pressure transducer (9) is evaluated and
indicated on the monitor as TMP. The fluid level in the secondary air separator (88b) is monitored by the
level sensor (6). Due to the secondary air separator (88b), only airless dialysate is always delivered into
the balancing chamber (68). Any presence of air bubbles in the balancing chamber (68) would cause
balancing errors.
The dialysate is pressed into the balancing chamber (68) by the flow pump (21). As mentioned above, the
balancing chamber valves are reversed by the current rise pulses of the drive motor of the flow pump.
Using the speed of this pump, the dialysate flow can be adjusted in the dialysis program: 300, 500, and
800 ml/min. In the cleaning programs, the flow of the dialysate is fixed.
The relief valve (78) is used to limit the pressure of the flow pump before the balancing chamber to
approximately 2 bar.
After the balancing chamber, the dialysate flows through the valve (30), the heat exchanger (77) and the
valve (87) into the drain.
The valves (86) and (87) serve to recirculate fluid during the hot rinsing and disinfection programs.

2.3.2 Functional principle of the balancing chamber
 (Standard program)
1st cycle:
30
31 32 33 34
F1 A1 F2 A2
68
35 36 37 38
21
2nd cycle:
30
31 32 33 34
F1 A1 F2 A2
68
35 36 37 38
21

1st cycle Closed valves: 31, 34, 36, and 37

F1 is filled with fresh solution.
A1 used solution is discharged into the drain.
F2 fresh solution is forced into the dialyzer.
A2 is filled with used solution.
2. cycle Closed valves: 32, 33, 35, and 38

F1 fresh solution is forced into the dialyzer.
A1 is filled with used solution.
F2 is filled with fresh solution.
A2 used solution is discharged into the drain.
This system ensures that equal amounts of fluid enter and exit the dialyzer. This leads to an exact
balancing of the dialysate and, in conjunction with the ultrafiltration pump (22), a controlled volumetric
ultrafiltration.
 Secondary air purging by the air separation pump 97
As soon as the fluid level in the secondary air separator (88b) has dropped below the level sensor (6), this
sensor activates the air separation pump (97). If the fluid level has reached the level sensor (6) within a
given time period, the FILL PROGRAM is started.
Note
In order to recognize the fluid level, the level sensor (6) requires fluid
with a certain minimum conductivity, which is definitely achieved in all
dialysis programs. Separation of air is only required in the dialysis
programs.
In all other programs, the air separation pump (97) and the valve (43)
are force-actuated.

 FILL PROGRAM: Air separation through valve 43 at atmospheric pressure
1st cycle:
30
31 32 33 34
76 97
43
F1 A1 F2 A2
68
6
35 36 37 38
6
88b
21
9
84
2nd cycle:
30
31 32 33 34
76 97
43
F1 A1 F2 A2
68
6
35 36 37 38
6
88b
21
9
84

If not enough air was separated and the fluid level is still below the level sensor (6), the FILL PROGRAM
is activated.
The pump (21) fills either chamber A1 or chamber A2. Valves (36), (38), and (30) close. Valve (43) opens.
The air can escape into the drain.
1st cycle Chamber F1 is filled. This forces the fluid from chamber A1 into
chamber A2. The fluid is then forced into the secondary air
separator (88b) by chamber A2 via the dialyzer.
2nd cycle Chamber F2 is filled. This forces the fluid from chamber A2 into
chamber A1. The fluid is then forced into the secondary air
separator (88b) by chamber A1 via the dialyzer.
Filling is performed in this way to prevent a change in conductivity. As in the standard program, one stroke
of the concentrate pump is still executed per balancing chamber cycle (30 ml) here as well.
A fill program is always activated at the beginning of dialysis (to fill the dialyzer). If it is activated during
the treatment (OD senses blood), this is shown on the display.
Note
Repeated activation of the fill program during treatment indicates a
defect (leakages).

2.3.3 Optional Central Delivery System
The Central Delivery System is connected to the connectors 121/122. The concentrate flows into the rinse
chambers via the inlet filters and the valves 102/104. Through the connected concentrate suction tubes,
the concentrate pumps deliver the concentrate to the mixing point.
During dialysis, the valves 91/99 and 100 are closed. Depending on the Central Delivery System, the
V102 and / the V104 are opened.
During the cleaning programs, the valves 102 and 104 are closed. During the suction phase of the
concentrate pump and bicarbonate pump, the valves 91 and 99 open for 500 ms upon each balancing
chamber switching. Valve 100 is open.
In order to check the tightness of the valves 102 and 104, the pressure switch is tested during the free
rinse phase with following disinfection or hot disinfection or a mandatory rinse. To perform this test,
pressure is applied to the two lines between the check valves 117/118 and the valves 102/104. The
pressure switches P123 and P124 are used to monitor the pressure. Three minutes before the mandatory
rinse program is completed, a functional check of the valves 91/99 and 100 is performed.

2.3.4 Program sequences in cleaning programs
Fig.: Cleaning programs flow diagrams – overview
End of dialysis
Rinse Hot rinse Disinfection (cleaning)
PGM 1: –R– PGM 1: –F–HR–C– PGM 1: –F–D–M–

PGM 2: –R– endless PGM 2: –F–HR– PGM 2: –F–HDIS–M–
PGM 3: –IHR– / IHR–C– PGM 3: –F–D–M–HR–
PGM 4: –F–HDIS–M–HR–
PGM 5: –F–D(F)–M–
Dialysis
 Explanation of abbreviations used
PGM Program
R Rinse
–R– Rinse endless
endless
F Free rinse
HR Hot rinse
C Cooling rinse
D Disinfection
D(F) Cleaning
Disinfectant drawn in from the front (concentrate suction tube).
HDIS Hot disinfection
M Mandatory rinse
IHR Integrated hot rinse
 Notes on the program sequences
At the end of the set program, the rinse chamber is evacuated for approx. 1 minute.
Any statements on time refer to the factory setting. Shorter or longer program times can be set at any time
using the SETUP menu (see Chapter 7 on page 7-1).

 Rinse
PGM 1: –R–
T/°C
37
33
t/min
Evacuation of
Rinse rinse chambers
per 10 strokes
15–30 min (Setup) approx. 1 min
Start End
(Rinse key)
PGM 2: –R– endless
T/°C
37
33
t/min
Rinse endl.
Start End
(Rinse key) (Program abort)

 Hot rinse
PGM 1: –F–HR–C–
T/°C
80
37
34,5
Evacuation of
t/min
Heat-up Hot rinse time-counting above Cooling rinse to
rinse chambers
Free rinse 80 °C 34.5 °C
per 10 strokes
approx. 6 min 15–30 min (Setup) approx. 8 min approx. 1 min
4–10 min approx.
(Setup) 4 min End
Start
(Hot rinse key)

PGM 2: –F–HR–
T/°C
80
37
Evacuation of
t/min
Heat-up Hot rinse time-counting above
rinse chambers
Free rinse 80 °C per 10 strokes
approx. 6 min 15–30 min (Setup) approx. 1 min
4–10 min approx.
(Setup) 4 min End
Start
(Hot rinse key)

PGM 3: –IHR–
T/°C
80
Evacuation of t/min
rinse chambers
Integrated hot rinse
per 10 strokes
approx. 1 min
15–40 min (Setup)
Start End
(Hot rinse key)

PGM 3: –IHR–C–
T/°C
approx. 80
approx. 35
t/min
Evacuation of
Heat-up Integrated hot rinse Cooling rinse rinse chambers
per 10 strokes
approx. 5 min 15–40 min (Setup) Temperature- approx. 1 min

controlled
Start End
(Hot rinse key)

 Disinfection
PGM 1: –F–D–M–
T/°C
37
33
Evacuation of
t/min
Free rinse Pre.* Disinfection Mandatory rinse rinse chambers
per 10 strokes
4–10 min approx. 10–20 min 15–30 min approx. 1 min
(Setup) 1 min (Setup) (Setup)
Start Mandatory rinse required End
(Disinfection key)
*Pre.: Preparation phase:

Heater off
Set the level of the float chamber below
the lower switching point
by means of 1 balancing chamber switching and 4 UF pump strokes.
Draw in disinfectant with 50 UF pump strokes.

PGM 2: –F–HDIS–M–
T/°C
80
37
34,5
Evacuation of
t/min
Free rinse Pre.*
Hot disinfection Mandatory rinse rinse chambers
Heat-up per 10 strokes
4–10 min approx. approx. 10–20 min (Setup) 15–30 min (Setup) approx. 1 min
(Setup) 1 min 4 min
approx. 6 min
Start Mandatory rinse required End
(Disinfection key)

Heater off

PGM 3: –F–D–M–HR
T/°C
80
37
33
Evacuation of t/min
Disinfec- Mandatory rinse Hot rinse rinse chambers
Free rinse Pre.* tion Heat-up per 10 strokes
4–10 min approx. 10–20 min 15–30 min approx. 15–30 min
(Setup) 1 min 4 min (Setup) approx. 1 min
(Setup) (Setup)
approx. 6 min
Start End
(Disinfection key)
* Pre.: Preparation phase:

Heater off

T/°C
80
37
Evacuation of t/min
Free rinse Pre.* Hot Mandatory rinse Hot rinse
rinse chambers
disinfection Heat-up
Heat-up per 10 strokes
4–10 min approx. approx. 10–20 min 15–30 min approx. 15–30 min
4 min (Setup) approx. 1 min
(Setup) 1 min 4 min (Setup) (Setup)
approx. 6 min approx. 6 min
Start Mandatory rinse End
(Disinfection key) required

Heater off

PGM 5: –F–D(F)–M–
T/°C
37
33
t/min
Evacuation of
Free rinse Pre.* Disinfection Mandatory rinse rinse chambers
per 10 strokes
4–10 min approx. 10–20 min (Setup) 15–30 min (Setup)
1 min approx. 1 min
(Setup)
Start Mandatory rinse required
End
(Disinfection key)

Heater off
the lower switching point of the float switch by means of 23 UF pump strokes.
Draw in disinfectant with 32 concentrate pump strokes of 330 steps each.
2.4 External alarm input messages
The following messages are possible depending on the setting of the DIP switches (see Chapter 4.1.2 on
page 4-11):
Message Description
External alarm Alarm at external alarm input

– Clear alarm.
– Press the Start/Reset key.
Patient warning Patient key (manufacturer) was pressed.

– Press the Start/Reset key.
RO-system alarm Error in single-station reverse osmosis system

– Check single-station reverse osmosis.
RO Power Failure Error in single-station reverse osmosis system

– Check single-station reverse osmosis.
RO is rinsing Clean the single-station reverse osmosis system.
RO-Mandatory rinse Message occurs after cleaning the single-station reverse osmosis system.
– Run the device's mandatory rinse program.


Chapter 3: Installation and Technical Safety Checks / maintenance procedures
3 Installation and Technical Safety

Checks / maintenance procedures
3.1 Initial start-up
3.1.1 Important information on initial start-up
For initial start-up only The following information is only intended for the initial start-up. This
information does not apply to recommissioning devices that have been
taken out of service even temporarily.
Environmental conditions Variations in temperature during transport may cause condensation

leading to water developing on live parts. In the event of major
variations in temperature, allow sufficient time for the device to adjust to
the ambient temperature before start-up. When moving the device from
a cooler into a warmer room, allow about 2 hours for the device to adjust
to the ambient temperature before switching it on.
Tester's qualification The tests may only be performed by persons qualified to perform the
specified checks correctly owing to their educational background,
training, knowledge, and experience. Furthermore, the persons
performing the checks must be permitted to do so independently and
without outside interference.
Warning
Test equipment and The activities described in this document require the availability of the
accessories necessary technical test equipment and accessories.
Specifications Observe the information on the specifications.
Correcting settings Settings must only be corrected if the measured values fall outside the
specified tolerances.
Precautions Before turning the power on, repair any visible damage.
Prior to opening the device and when working on the open device, the
following precautions have to be observed:
– Do not touch live parts.
– All plugs, connections, and components must only be disconnected
or connected when the device is turned off.
ESD precautions When repairing the device and replacing spare parts, observe the
relevant ESD precautions.

TSC / MA intervals TSC / MA must be performed on this device after 24 months.
3.1.2 Initial start-up report
See the following pages.

4008 B / 4008 H /
Initial start-up report
4008 S
Name of technician: Customer / Customer no.:
Device type including Serial no.: Inventory no.:

option(s) / software version:
Service report no.: Operating hours: Equipment code:
No. Description Operating state Correction Meas. value 

1 Visual inspections
1.1 4008 B/S: Battery fuse checked and inserted Off – – 
4008 H: Cable connected to battery
1.2 Labels and inscriptions are present and legible Off – – 
1.3 Mechanical condition permits further safe use Off – – 
1.4 There are no signs of damage or contamination Off – – 
1.5 Power cable not damaged Off – – 
1.6 Color coding of the dialyzer couplings and of the shunt interlock adapted to Off – –
customer specifications (counter-current principle)
State upon delivery: 
Dialysate inlet (right): Dialyzer coupling and shunt interlock = red
Dialysate outlet (left): Dialyzer coupling and shunt interlock = blue
Dialysate inlet (right): Dialyzer coupling and shunt interlock = blue 
Dialysate outlet (left): Dialyzer coupling and shunt interlock = red
1.7 Closing plugs removed: Off – 
Heater block overflow tube, disinfectant connector, water inlet plate
2 Preparation for operation
2.1 Water inlet tube connected. Drain tube connected Off – 
2.2 CDS tubes connected Off – 
2.3 DIP switch checked Off – 
2.4 Battery connected Off – 
2.5 V91, V99, V100 are functional and tight Off – 
(This test is not applicable if the CDS or the rinse section test is activated.)
2.6 Preservatives have been rinsed Cleaning / – 
Rinsing
2.7 DIASAFE® plus filter is connected, Cleaning / – 
"Filter change" program completed Filter change
2.8 Emergency crank for blood pump attached to housing rear Off – 
3 Check of the hydraulics
3.1 Water inlet pressure (reduced): CALIBRATION  Yes 
1.2 bar (+0.2 bar / –0.3 bar)  No
3.2 Loading pressure: CALIBRATION  Yes 
1.45 bar (±0.05 bar) [3mix: 1.25 bar (±0.05 bar)]  No
3.3 Degassing pressure: CALIBRATION  Yes 
–0.82 bar (±0.01 bar)  No
3.4 Relief pressure of balancing chamber at 800 ml/min: CALIBRATION  Yes 
2.2 bar (±0.05 bar) [3mix: 2.0 bar (±0.05 bar)]  No
4 Check of the zero point of the pressure display (art. / ven.)
4.1 Arterial zero point: CALIBRATION  Yes 
Desired: 0 mmHg (±10 mmHg)  No
4.2 Venous zero point: CALIBRATION  Yes 
Desired: 0 mmHg (±10 mmHg)  No


5 Check of dialysate flow
5.1 Dialysate flow 800 ml/min: CALIBRATION  Yes 
Desired: 765 to 837 ml/min  No
6 Check of temperature
6.1 Temperature of reference measuring instrument: CALIBRATION  Yes 
Desired: 37 °C (±1 °C)  No
6.2 Device temperature display: CALIBRATION  Yes 
Desired: 37 °C (±0.5 °C)  No
7 Check of conductivity
(If the bibag® option is used, connect a bibag®)
7.1 Conductivity of reference measuring instrument CALIBRATION  Yes 
 No
7.2 Conductivity of device display: CALIBRATION  Yes 
Desired: Reference measuring instrument value (±0.2 mS/cm)  No
8 Check of the blood leak detector
8.1 Blood leak: CALIBRATION  Yes 
Desired: 5 V (±0.2 V)  No
8.2 Dimness: CALIBRATION  Yes 
Desired: 5 V (±0.3 V)  No
9 Check of dialysate pressure
9.1 Zero point checked (flow off) CALIBRATION – – 
9.2 Slope checked CALIBRATION – – 
10 Check of the extracorporeal components
10.1 Blood pumps: CALIBRATION – – 
Check of blood pump rate (BP rate TEST)
10.2 Single Needle switching pressure checked CALIBRATION – – 
11 Setup menu settings (PC service program)
11.1 Making settings in the setup menu and transferring data to the dialysis CALIBRATION – – 
device
11.2 Resetting the failure record CALIBRATION – – 
11.3 Downloading setup and calibration data CALIBRATION – – 
(PC service program)
11.4 Printing the setup data CALIBRATION – – 
12 Check of the electrical safety
According to (DIN) EN 62353:2008, IEC 62353:2007
12.1 Visual inspections performed according to item 1 Off – – 
12.2 Protective earth resistance measured. Off – 
Maximum 0.3 Ω (with power cable) Ω
12.3 Device leakage current measured Preparation – – 
 Device leakage current – differential current measurement according
to fig. 5
or
 Device leakage current – direct measurement according to fig. 4
Nominal voltage of power supply: V – –
Device leakage current mains polarity 1: – μA
For line voltage: – V
Normalized to nominal voltage –
(maximum 500 μA, see Additional conditions) μA
Device leakage current mains polarity 2: – μA
For line voltage: – V
Normalized to nominal voltage –
13 Functional check
13.1 T1 Test completed T1 test – – 
13.2 Blood pressure measured (option). Preparation – – 
Measured values are plausible
13.3 Blood pump stop alarm checked Preparation – – 
13.4 Venous occlusion clamp closes after blood alarm Preparation – – 
13.5 Pressure of approx. 2 bar in the venous bubble catcher. Preparation – – 
Pressure must not drop by more than 0.1 bar within 3 minutes
14 Final checks
14.1 Power failure alarm – continuous sound – text displayed: Dialysis – – 
Emergency operation
14.2 Air separation: Dialysis – – 
Activation of the air separation pump. If more air must be separated and OD
senses blood, the display shows: Fill program


14.3 Preset temperature at 37 °C: Dialysis – 
Desired: 36.8 °C to 37.2 °C
14.4 Expected conductivity Dialysis – 
14.5 Disinfection program completed Cleaning / – – 

Disinfection
14.6 Entries recorded in the medical device register and machine card Off – – 
14.7 Instructions for Use and accessories package are complete and match the Off – – 
device
14.8 TSC inspection label attached Off – – 
Test equipment used:

Temperature, conductivity, pressure
(type, serial number):
Protective earth resistance, leakage current

Remarks:
Date: Signature: Stamp:
#FMESIG_1##
The device is released for its intended use  Yes

(attach inspection label)  No
Date of next check:
Remarks:
#FMESIG_2##
Warning
On completion of these procedures it is imperative to run a disinfection.

3.1.3 Explanatory notes for completing the initial start-up report
Identification Name of technician:

 Enter the first name and last name of the technician carrying out the
work.
Device type including option(s) / software version:
 Document the device name with possible options or extras.
 Document the software version.
Service report no.:
 Document the number of the service call.
Customer / Customer no.:
 Document customer name and / or customer number.
Serial no.:
 Document the serial number, as shown on the identification label.
Inventory no.:
 Document the inventory number assigned to the device.
Operating hours:
 Document the number of operating hours.
Equipment code:
 Document the equipment code as shown on the device
(e.g., EC xxx, E-code xxx).
Re 1 Visual inspections
Re 1.1 4008 B/S: Battery fuse checked and inserted

4008 H: Cable connected to battery
Operating state: Off
4008 B/S:
 Check and insert the battery fuse.
4008 H:
 Connect the cable to the battery.

Re 1.2 Labels and inscriptions are present and legible

 Check whether all labels and inscriptions are present on the device
and legible.
1
Type : IPX1
SN : EC :
: 2
Power :
Current :
Index_H
Fresenius Medical Care AG & Co.KGaA
D-61346 Bad Homburg
2011 +49 (0) 6172 / 609-0
 Check device information, such as serial number (1) and equipment

code (2).
Re 1.3 Mechanical condition permits further safe use

 Check the mechanical condition of the device to make sure it permits
safe use.
Re 1.4 There are no signs of damage or contamination

 Check that the electrical and mechanical properties are not affected
by damage or contamination.
Re 1.5 Power cable not damaged

 Check the power cable for damage.
Re 1.6 Color coding of the dialyzer couplings and of the shunt interlock
adapted to customer specifications (counter-current principle)
 Adapt coding of the dialyzer couplings and of the shunt interlock as
desired by the customer. Ensure counter-current principle by correct
color coding.
 Document the change in the medical device register.
State upon delivery:
Dialysate inlet (right): Dialyzer coupling and shunt interlock = red
Dialysate outlet (left): Dialyzer coupling and shunt interlock = blue

Re 1.7 Closing plugs removed:

Heater block overflow tube, disinfectant connector, water inlet
plate
 Remove the closing plugs from the heater block overflow tube.
 Remove the closing plugs from the disinfectant connector.
 Remove the closing plugs on the water inlet plate.
Re 2 Preparation for operation
Note
Risk of tubing constriction
Risk of damage to the connectors
 Tie the tubes up so that they are not subject to any kinking, tension,
torsion, and squeezing.
Re 2.1 Water inlet tube connected. Drain tube connected

 Connect the water inlet tube.
 Connect the drain tube.
 Secure the tubes so that they do not slip out.
Re 2.2 CDS tubes connected

 Connect the CDS tubes.
 Secure the tubes so that they do not slip out.
Re 2.3 DIP switch checked

The basic position upon delivery is shown in italics. For "not used", the
switch must be set to OFF.
Check of DIP switches PCB LP 631 (CPU1):
Note
DIP switch 6 (field 1) is provided for servicing / troubleshooting only and
must be set to OFF for treatment.
 Check the DIP switch on PCB LP 631 field 1 (SW1)

(see the following table).

SW1 SW2 LP631

1 2 3 4 5 6 7 8
ON
OFF
DIP switch / Function

position
1 2 Maximum UF rate
ON ON 1000 ml/h
OFF ON 2000 ml/h
ON OFF 3000 ml/h
OFF OFF 4000 ml/h
3 4 5 Language 1 Language 2 Language 3 Language 4
ON ON ON English English English English
OFF ON ON German Finnish Japanese Hungarian*
ON OFF ON French Czech Bulgarian Romanian**
OFF OFF ON Portuguese Danish Greek
ON ON OFF Dutch Russian Arabic*
OFF ON OFF Italian Turkish Norwegian*
ON OFF OFF Swedish Polish Slovenian*
OFF OFF OFF Spanish Slovakian Ex-
Yugoslavian*
6 CRC/RAM test
ON Skip
OFF Perform
7 Heater rod
ON 1300 W (at 100 to 120 V)
OFF 1600 W (at 220 to 240 V)
8 Test flow
ON 500 ml/min
OFF 800 ml/min
*
4008 H/S only
**
4008 H Prometheus only
 Check the DIP switch on PCB LP 631 field 2 (SW2).
SW1 SW2 LP631

1 2 3 4 5 6 7 8
ON
OFF
DIP switch / position Function

1 CAL mode
ON Mode 0
OFF Mode 1
2 3 External alarm input
ON ON Not valid
OFF ON RO system
ON OFF Patient bell
OFF OFF External alarm
4 Remote control
ON Device with remote control
OFF Device without remote control
5 COMMCO PCB LP 763 or PCB LP 758 or PCB LP 729
ON Enabled
OFF Disabled


6 COMMCO
ON Special record
OFF Standard record
7 Rinse section test (not CDS)
ON Active
OFF Not active
8 Central Delivery System
ON Installed
OFF Not installed
Check of DIP switches PCB LP 632 (CPU2):

Warning
DIP switches 3 and 8 (field 1) allow the operator to skip test steps that
are requested by the device.
If the switches are set to the "can be skipped" position, it is important to
know that the operator can then bypass the automatic test of the safety
systems.
The person requesting this setting is responsible for this procedure.
LP632 SW1 SW2

1 2 3 4 5 6 7 8
ON
OFF

1
ON
OFF Not assigned
2 T1 test
ON Serial sequence
OFF Parallel sequence
3 T1 test
ON Skip
OFF Mandatory
4 Service test
ON ON (dialysis not possible)
OFF OFF (automatic T1 test)
5 Cyclic PHT
ON Every 2 minutes and indication of the test result (service)
OFF Every 12.5 minutes, alarm output only with cyclic PHT alarm
6 Cyclic PHT
ON ON
OFF OFF
7 Level detector
ON PCB LP 450 without AD28
OFF PCB 450-2 and/or with AD28
8 HDF test
ON Can be skipped
OFF Mandatory

LP632 SW1 SW2

1 2 3 4 5 6 7 8
ON
OFF

1 DIASAFE / DIASAFE® plus
ON ON
OFF OFF
2 ONLINE HDF
ON ON
OFF OFF
3 ONLINEplus™
ON ON
OFF OFF
4 Hydraulics
ON with HPU
OFF without HPU
5 V39 test
ON OFF
OFF ON
6 HDIS fast heater
ON Inactive
OFF Active
7
ON
OFF Not assigned
8
ON
OFF Not assigned
Re 2.4 Battery connected

4008 B/S:
 Insert battery fuse (3.15 AT).
4008 H:
 Establish a connection.
Re 2.5 V91, V99, V100 are functional and tight (test not applicable with
activated CDS or with activated rinse section test)
 Check the external valves to make sure they are functional and tight.
Activate the valves with the diagnostics program.
This test is not required
– when CDS is activated, PCB LP 631 SW2 DIP switch 8 is ON,
– when rinse section test is activated, PCB LP 631 SW2 DIP switch 7
is ON.

Re 2.6 Preservatives have been rinsed

Operating state: Cleaning / Rinsing
 Turn the device on.
 Wait until the device is completely booted up.
 Move the service switch to ON (up) (heater rod not active!).
 Press the Rinse key.
 Once the rinse program is complete, move the service switch to OFF
(down).
Re 2.7 DIASAFE® plus filter connected,

"Filter change" program completed
Operating state: Cleaning / Filter change
 Connect the DIASAFE® plus filter.
 Run the Filter change program.
 Use the "Filter change" program item in the cleaning menu and start
the disinfection program requested by the device.
Re 2.8 Emergency crank for blood pump attached to housing rear

 Attach the blood pump emergency crank to the housing rear.
Re 3 Check of the hydraulics

Use only approved pressure gages to measure pressure
(see Test equipment and accessories on page 4-1).
Re 3.1 Water inlet pressure (reduced): 1.2 bar (+0.2 bar / –0.3 bar)
Operating state: CALIBRATION
 Connect a pressure gage to measuring point A in the hydraulic unit
before MV41.
 Check the water inlet pressure when MV41 is closed.
Desired: 1.2 bar (+0.2 bar / –0.3 bar).
Re 3.2 Loading pressure: 1.45 bar (±0.05 bar) [3mix: 1.25 bar (±0.05 bar)]
 Connect a pressure gage to the pressure side of the degassing
pump on measurement point B in the HU.
 Check loading pressure.
Desired: 1.45 bar (±0.05 bar) [3mix: 1.25 bar (±0.05 bar)].
Re 3.3 Degassing pressure: –0.82 bar (±0.01 bar)

 Connect a pressure gage to the suction side of the degassing pump
on measurement point D in the HU.
 Check the degassing pressure.
Desired: –0.82 bar (±0.01 bar).

Re 3.4 Relief pressure of balancing chamber at 800 ml/min:

2.2 bar (±0.05 bar) [3mix: 2.0 bar (±0.05 bar)]
 Connect a pressure gage to the pressure side of the flow pump on
measurement point C in the HU.
 Set a flow rate of 800 ml/min.
 Check the relief pressure.
Desired: 2.2 bar (±0.05 bar) [3mix: 2.0 bar (±0.05 bar)].
Re 4 Check of the zero point of the pressure display (art. / ven.)
Re 4.1 Arterial zero point: Desired: 0 mmHg (±10 mmHg)

 Check the arterial zero point.
Desired: 0 mmHg (±10 mmHg).
Re 4.2 Venous zero point: Desired: 0 mmHg (±10 mmHg)

 Check the venous zero point.
Desired: 0 mmHg (±10 mmHg).
Re 5 Check of dialysate flow
Re 5.1 Dialysate flow 800 ml/min: Desired: 765 to 837 ml/min

 Set and check a flow rate of 800 ml/min.
Desired: 765 to 837 ml/min.
 If necessary, set the flow according to calibration instructions.



Re 6 Check of temperature
Re 6.1 Temperature of reference measuring instrument:

Desired: 37 °C (±1 °C)
 Check the desired temperature of 37.0 °C using a reference
measuring instrument connected between the dialyzer couplings.
Desired: 37 °C (±1 °C).
Re 6.2 Device temperature display: Desired: 37 °C (±0.5 °C)

 Check the display on the device (NTC 109 not active).
Desired: 37 °C (±0.5 °C).
Re 7 Check of conductivity
(If the bibag® option is used, connect a bibag®)
Re 7.1 Conductivity of reference measuring instrument

 Check the conductivity using a reference measuring instrument
connected between the dialyzer couplings.
Re 7.2 Conductivity of device display:

Desired: Reference measuring instrument value (±0.2 mS/cm)
 Check the display on the device.
Desired: Reference measuring instrument value (±0.2 mS/cm).
Re 8 Check of the blood leak detector
Re 8.1 Blood leak: Desired: 5 V (±0.2 V)

Basic conditions:
– The device must be connected
(avoid incident light from external sources).
– The temperature must have reached 37 °C.
 Check the blood leak voltage.
Desired: 5 V (±0.2 V).
Re 8.2 Dimness: Desired: 5 V (±0.3 V)

Basic conditions:
– The device must be connected
(avoid incident light from external sources).
– The temperature must have reached 37 °C.
 Check the dimness voltage.
Desired: 5 V (±0.3 V).

Re 9 Check of dialysate pressure

The dialysate pressure transducer 2 (PDial2) is only fitted in new
hydraulics units with hydraulics processing units.
Re 9.1 Zero point checked (flow off)

Basic conditions:
– Venous pressure inlet is open to the atmosphere.
– Flow off.
– When the dialysate circuit is open, the water level must be
approximately 10 cm above the shunt interlock.
 Check zero point (see Part 14: Calibrating the dialysate pressure
(stainless steel pressure transducer) on page 5-34).
Re 9.2 Slope checked

 Check slope (see Part 14: Calibrating the dialysate pressure
(stainless steel pressure transducer) on page 5-34).
Re 10 Check of the extracorporeal components
Re 10.1 Blood pumps: Check of blood pump rate (BP rate TEST)
 Check the blood pump rate (BP rate TEST).
Re 10.2 Single Needle switching pressure checked

 Check switching points (see Chapter 2.2.2 on page 2-77).
Re 11 Setup menu settings (PC service program)
Re 11.1 Making settings in the setup menu and transferring data to the
dialysis device
 Adjust the setup settings in the PC service program.
 Transfer data to the dialysis device.
Re 11.2 Resetting the failure record

 Resetting the failure record
Re 11.3 Downloading setup and calibration data (PC service program)

 Download setup and calibration data using the PC service program.

Re 11.4 Printing the setup data

 Print out the setup data.
Re 12 Check of the electrical safety

Re 12.1 Visual inspections performed according to item 1

 Perform visual inspections according to item 1.
Re 12.2 Protective earth resistance measured.

Maximum 0.3 Ω (with power cable)
4008 H:
 Test the protective earth resistance at the following measurement
points.
Desired: Protective earth resistance < 0.3 Ω.
1
9
2
3
8
6
Legend:
1 Upper rear panel (screw)
2 Heat sink (power supply unit)
3 Monitor rear panel (plate)
4 Power supply plate
5 Heater rod housing (hydraulic unit open)
6 Dialyzer tube ports
(hydraulic unit open / earthing screw)
7 Bonding studs
8 Hydraulic unit rear panel (plate on the push-on blade inside)
Caution: The protective conductor must be connected.
9 Monitor rear panel (ports housing)

4008 B, 4008 S:
 Test the protective earth resistance at the following measurement
points.
Desired: Protective earth resistance < 0.3 Ω.
Legend:
4 Dialyzer tube ports (adapters)
5 Bonding studs

Re 12.3 Device leakage current measured

Operating state: Preparation
Device leakage current – differential current measurement according
to fig. 5
or
Device leakage current – direct measurement according to fig. 4
Basic requirements for the differential current measurement according

to fig. 5:
– Measurement of the protective earth resistance has been
completed.
– Perform the measurement with the device at operating temperature.
– Dialysate:
Dialysate temperature: ≥ 37.0 °C
Dialysate flow: ≥ 300 ml/min
Dialysate conductivity: ≥ 13 mS/cm
Basic requirements for the direct measurement according to fig. 4:
– The device must be insulated when installed.
– All external connections must have been removed from the device.
– Do not touch the device while the measurement is in progress.
– Measurement of the protective earth resistance has been
completed.
– Dialysate:
Nominal voltage of the power supply:

– Document the nominal voltage of the power supply.

Device leakage current, mains polarity 1:

– Measure and document the maximum device leakage current and
the current line voltage at mains polarity 1.
– Normalize the device leakage current at mains polarity 1 to the
nominal voltage of the power supply and document it.

– Measure and document the maximum device leakage current and
the current line voltage at mains polarity 2.
– Normalize the device leakage current at mains polarity 2 to the
nominal voltage of the power supply and document it.
Check the measurements:

– Check the normalized device leakage current at mains polarity 1,
taking the Additional conditions into account.
Maximum normalized device leakage current ≤ 500 µA
– Check the normalized device leakage current at mains polarity 2,
taking the Additional conditions into account.
Example 1 – measurements normalized and checked:

Nominal voltage of the power supply: 230 V
Device leakage current, mains polarity 1: 180 µA
Line voltage to device leakage current, mains polarity 1: 225 V
Normalized device leakage current at mains polarity 1: 184 µA
(180 µA : 225 V x 230 V = 184 µA).
Device leakage current ≤ 500 µA: passed
(198 µA : 220 V x 230 V = 207 µA).
Additional conditions:
If the value of the leakage current normalized to the nominal voltage is
higher than 90% of the alarm limit (450 µA), the last measured value or
the first measured value must additionally be considered for the rating.
If the device leakage current has considerably increased since the last
measurement or has continuously increased since the first
measurement (slow deterioration of the insulation), or if the sum
composed of the current value plus the difference since the last
measurement is > 500 µA, the measurement is considered "not
passed".
Example 2 – Additional conditions passed:
Device leakage current: 470 µA
Last measured value: 450 µA
470 µA + (470 µA – 450 µA) = 470 µA + 20 µA = 490 µA: passed.
Example 3 – Additional conditions not passed:
470 µA + (470 µA – 390 µA) = 470 µA + 80 µA = 550 µA: not passed.

Re 13 Functional check
Re 13.1 T1 Test completed

Operating state: T1 test
 Wait for successful T1 Test.
Re 13.2 Blood pressure measured (option).

Measured values are plausible
Basic conditions:
– Tube and blood pressure cuff connected.
 Perform measurement in the BPM’s manual mode.
 Following measurement, check values for plausibility.
Re 13.3 Blood pump stop alarm checked

 Set blood pump delivery rate > 0 ml/min (blood pump must rotate).
 Open blood pump door and check that the rotor stops immediately.
 Check that the blood pump stop alarm triggers after max.
30 seconds (setup menu settings: 15 / 30 seconds).
Red status indicator (LED) on blood pump lights up,
operating status indicator (traffic light) lights up,
4008 S: Message (screen): Alarm – Bloodpump-stop,
4008 B: Message (text display): Bloodpump-stop Alarm.
Re 13.4 Venous occlusion clamp closes after blood alarm

 Following a blood alarm, check that the venous occlusion clamp
closes.
Re 13.5 Pressure of approx. 2 bar in the venous bubble catcher.

Basic conditions:
– Venous occlusion clamp is closed.
 Insert the venous bubble catcher into the level detector (ultrasonic
detector). Do not yet place the tube into the venous occlusion clamp.
 Manually open the venous occlusion clamp, hold it, and insert the
tube.
 Release the venous occlusion clamp.
The venous occlusion clamp closes.
 Use the syringe to generate pressure of approximately 2 bar.
 Measure the stable pressure.
 Test the pressure drop after 3 minutes.
Desired: Pressure drop < 0.1 bar (see Chapter 4.4 on page 4-30).

Re 14 Final checks
Re 14.1 Power failure alarm – continuous sound – text displayed:

Emergency operation
Operating state: Dialysis
 Disconnect the power plug.
 Check the continuous sound and text display.
Desired: Continuous sound and Emergency Operation text display.
Re 14.2 Air separation: Activation of the air separation pump. If more air
must be separated and OD senses blood, the display shows:
Fill program
 Simulate OD sensing blood.
 Activate the air separation pump.
 Check the text display by separating more air.
Desired: Text display Fillprogram.
Re 14.3 Preset temperature at 37 °C: Desired: 36.8 °C to 37.2 °C

Basic conditions:
– Complete test when the device is fully closed.
– Optical detector = dark (NTC 109 is active).
 Check the desired temperature of 37.0 °C using a reference
measuring instrument connected between the dialyzer couplings.
Desired: 36.8 °C to 37.2 °C
Re 14.4 Expected conductivity

 Compare the conductivity display on the monitor with the information
on the acid / acetate canisters.
Re 14.5 Disinfection program completed

Operating state: Cleaning / disinfection
 Run the disinfection program.
Re 14.6 Entries recorded in the medical device register and machine card
 Record entries in the medical device register.
 Record entries in the machine card.
Re 14.7 Instructions for Use and accessories package are complete and
match the device
 Check whether the Instructions for Use and accessories package
are complete and that they match the device.

Re 14.8 TSC inspection label attached

 Attach the TSC inspection label.
Confirmation of the test Test equipment used:

 Document the type and serial number of the test equipment used.
Remarks:
 Record any irregularities that arose during the tests.
Date, signature, stamp
 Confirm the test with the date, tester’s signature, and stamp.
Assessment of the test The device is released for its intended use
(attach inspection label)
There must be no risk to patients, staff, or third parties during the
intended use of the device.
Within the scope of the overall assessment, the tester must make a
definite decision as to whether or not the device may be used. The
responsible organization must be informed without delay of any defects
detected.
 Decide whether or not the system can be released for its intended
purpose.
 Inform the responsible organization of any defects in the device
without delay.
Date of next check:
 Document the date of the next test in the report.
 Respect the intervals specified by the manufacturer.
Remarks:
 Record any irregularities which influenced your assessment.
Date, signature, stamp:
 Confirm the initial start-up assessment with the date, tester’s
signature, and stamp.

3.2 Technical Safety Checks / maintenance procedures
3.2.1 Important information on TSC / MA
This chapter lists all necessary Technical Safety Checks (TSC) and Maintenance procedures (MA). The
Technical Measurement Checks (TMC) additionally stipulated for specific countries form part of the
Technical Safety Checks (TSC).
These checks must be performed every 24 months if all of the following requirements have been met:
– Unique assignment of the rotors to the appropriate tube roller pumps
– Software:
4008 B system: from 4.951 to < 5.00 or with 5.201 or higher
4008 H/S systems: from 2.951 to < 3.00 or from 4.311 to < 10.00
– DIP switch PCB LP632 array 2 SW 5 set to OFF.
– DIP switch PCB LP631 array 2 SW 7 set to ON.
– DIP switch PCB LP631 array 2 SW 8 set to ON. (With CDS option only)
– Heater rod made of Titanium
If one of the requirements mentioned above has not been met, the checks have to be performed
every 12 months.
Performance of the Technical Safety Checks must be recorded in the Medical Device Register.
 Precautions for working on the device
Warning
The activities described in the Technical Manual require the availability of the necessary technical test
equipment and accessories.
When working on the open device, the following precautions must be respected:
– Do not touch live parts (e.g., connectors on the power cable or heater).
When repairing and replacing spare parts, observe the applicable ESD precautions (e.g., EN 100 015-1).
3.2.2 TSC / MA report
TSC / MA report The TSC / MA report (see TSC / MA report on page 3-25) and the
TSC report TSC report (see TSC report on page 3-42) differ in the following points:
– Maintenance procedures (MA)
– Category TSC or MA in first column

Explanatory notes for The explanatory notes on the report are contained in a separate chapter
completing the report (see Chapter 3.2.3 on page 3-29).

4008 B / 4008 H /
TSC / MA report
4008 S
These checks must be performed every 24 months if all of the following requirements have been met: Interval:
 Unique assignment of the rotors to the appropriate tube roller pumps  24 months
 Software:  12 months
4008 B system: from 4.951 to < 5.00 or with 5.201 or higher (Please check)
 DIP switch PCB LP632 array 2 SW 5 set to OFF.
 DIP switch PCB LP631 array 2 SW 7 set to ON.
 DIP switch PCB LP631 array 2 SW 8 set to ON. (With CDS option only)
 Heater rod made of Titanium
every 12 months.
Name of technician Service report no.:
Serial number: Inventory no.: Operating hours:
Device type:  4008 B  4008 H  4008 S

With option:  DIASAFE® plus  OCM  ONLINEplus™  SN  bibag®
 BPM  BTM  BVM  DIASAFE  ONLINE HDF  4008 HDF
No. Description Meas. value 

TSC 1.1 Fuses accessible from the outside comply with the specified values – 
TSC 1.2 Labels and inscriptions are present and legible – 
TSC 1.3 Mechanical condition permits further safe use – 
TSC 1.4 There are no signs of damage or contamination – 
TSC 1.4.1 No signs of damage on the tube roller pump rotors – 
TSC 1.4.2 PCB LP 928 (CAN bus distributor) with covering checked (only 4008 S with E-Code 905 and lower) – 
TSC 1.5 Power cable not damaged – 
MA 1.6 Preventive measures
MA 1.6.1 Sealing plungers in suction tubes replaced and lubricated; rivets replaced – 
MA 1.6.2 Rubber in the rinse chambers checked for proper function – 
MA 1.6.3 Rinse chamber screws are tight – 
MA 1.6.4 Check valve replaced and, if required, CDS check valves 117/118 and filter 119/120 replaced – 
MA 1.6.5 Pre-UF pump filter, filter downstream of MV 43, filter between rinse chambers and on MV 99, – 
MV 100 replaced
MA 1.6.6 Dialysate filter replaced or sieve changed – 
MA 1.6.7 O-rings in dialyzer couplings replaced – 
MA 1.6.8 Sampling valve is functional – 
MA 1.6.9 Fan filter replaced – 
MA 1.6.10 Running band and tube segment of air separation pump replaced – 
MA 1.6.11 MV 84 (yellow label), replaced after 2 years. (Only applicable when using Puristeril 340, – 
Puristeril plus)
MA 1.6.12 Connecting piece or equilibration chamber replaced. – 
(Only when ONLINEplus™ and DIASAFE® plus options are not used)
MA 1.6.13 Filter 210 (if present) replaced – 
MA 1.6.14 Disinfectant filter replaced – 
MA 1.6.15 There are no dirty or worn tubes – 
MA 1.6.16 Every 4 years only: Battery replaced (ensure correct polarity!) – 
2 General checks
TSC 2.1 Power failure alarm – continuous sound – text displayed: Emergency operation – 


TSC 2.2 Air separation by air separation pump activated; text displayed if more air must be separated and – 
OD senses blood: Fill program
TSC 2.3 Check DIP switches – 
PCB LP 631 (CPU1) DIP switch array 2 SW7 is set to ON.
With Central Delivery System:
MA 3.1 Water inlet pressure (reduced) 0.9 bar to 1.4 bar 
MA 3.2 Loading pressure 1.25 bar ±0.05 bar 
From EC495 (4008 B); EC295 (4008 H) and EC275 (4008 S)
Loading pressure 1.45 bar ±0.05 bar
MA 3.3 Degassing pressure: –0.81 to –0.85 bar 
MA 3.4 Relief pressure of balancing chamber at 800 ml/min 
Loading pressure: Relief pressure:
1.2 to 1.3 bar 1.9 to 2.1 bar
1.45 ±0.05 bar 2.2 ±0.05 bar
4 Ultrafiltration system and membrane pumps
TSC 4.1 UF pump, 1 stroke = 1 ml, 
60 strokes = 60 ml ±0.5 ml (59.6 g ±0.5 g dialysis water)
MA 4.2 Concentrate pump calibration volume removal / number of strokes 
MA 4.3 Bicarbonate pump calibration volume removal / number of strokes 
5 Treatment
MA 5.1 Desired temperature 37 °C ±0.5 °C 
MA 5.2 Temperature display 37 °C ±0.5 °C 
MA 5.3 Dialysate pressure
– Flow off zero point checked 
– Slope checked 
TSC 5.4 Conductivity display checked with reference meter
If the bibag® option is used, connect a bibag®!
– CD device 
– CD ref. 
6 Extracorporeal components
MA 6.1 Arterial pressure display checked with reference meter – 
MA 6.2 Venous pressure display checked with reference meter – 
TSC 6.3 Blood pumps: Check of blood pump rate (calibration program: BP rate TEST) – 
TSC 6.4 SN switching pressure checked according to table in the Technical Manual – 
TSC 6.5 Blood pump stop alarm checked – 
TSC 6.6 Venous tube clamp closes after blood alarm – 
TSC 6.7 Pressure of approx. 2 bar in the venous bubble catcher. – 
7 Options
7.1 bibag®
MA 7.1.1 bibag® connector, O-rings replaced – 
MA 7.1.2 Switching pressure of PSW 134 checked, 130 mbar, + 30 mbar 
7.2 DIASAFE
MA 7.2.1 DIASAFE filter life checked – 
MA 7.2.2 Hydrophobic filter 111 replaced – 
MA 7.2.3 O-rings in the DIASAFE’s dialysate couplings checked – 
7.3 DIASAFE® plus
MA 7.3.1 DIASAFE® plus filter life checked – 
7.4 4008 HDF
TSC 7.4.1 2nd UF pump, 1 stroke = 1 ml, 
7.5 ONLINE-HDF (and DIASAFE)
MA 7.5.1 Filter life of DIASAFE and ONLINE filter checked – 
MA 7.5.3 O-rings in the DIASAFE’s dialysate couplings checked – 
MA 7.5.4 HDF pump rotor checked (smooth running, wear) – 
MA 7.5.5 Fastening strap for Luer-lock checked – 
TSC 7.5.6 Substituate pump – 
 with DC motor: Pump adjusted Desired /
or actual:
/
 with stepper motor: Pump rate checked (calibration program: HDF-Pump-Rate Check)


TSC 7.5.7 Substituate pump stop
– Following blood alarm – 
– After triggering the bypass function – 
– After opening the blood pump door – 
TSC 7.5.8 Check substituate pump for proper function:
– Rinse program, delivery rate: 400 ml/min – 
– Hot rinse program, delivery rate: 150 ml/min – 
– Disinfection program, delivery rate: 400 ml/min – 
7.6 ONLINEplus™ (and DIASAFE® plus)
MA 7.6.1 Filter life of DIASAFE® plus and ONLINEplus™ checked – 
MA 7.6.2 Hydrophobic filters 111 and 184 replaced – 
MA 7.6.3 O-rings at substituate port 195 and rinse port 194 replaced. – 
O-rings lubricated with Unisilkon grease before installation
TSC 7.6.4 Tube in the tube pinch valve 193 (ONL1) replaced – 
TSC 7.6.5 Check of DIP switch – 
PCB LP632 (CPU2) DIP switch array 2 switch 5 is set to OFF in HPU (hydraulics processing unit)
7.7 OCM
MA 7.7.1 OCM temperature / conductivity compensation test completed – 
– CD cell 7 
– CD cell 110 
– OCM PULSE calibration required?  Yes
 No
7.8 BPM 4008
The Technical Measurement Checks (TMC) additionally stipulated for specific countries form part of the
Technical Safety Checks (TSC).
MA 7.8.1 Labels and inscriptions are present and legible – 
MA 7.8.2 Mechanical condition permits further safe use – 
MA 7.8.2.1 Tube connection correctly connected to device – 
MA 7.8.2.2 Internal blood pressure module, printed circuit boards, cable connections properly attached – 
MA 7.8.2.3 Damaged tubes or cuffs have been replaced – 
MA 7.8.2.4 Indicating elements checked – 
MA 7.8.2.5 Touch panel checked – 
TSC 7.8.3 Leakage test: Pressure leakage rate less than 6 mmHg/min – 
TMC
TSC 7.8.4 Calibration:
TMC Pressure valuesTolerance
250 mmHg ±3 mmHg 
TSC 7.8.5 Safety valve: Drained at 320 mmHg, ±10 mmHg – 
TMC
TSC 7.8.6 Blood pressure measurement performed – 
TMC
7.9 BTM 4008
No further Technical Safety Checks and maintenance procedures must be performed
7.10 BVM 4008


Measurement points: (see Chapter 3.2.3.1 on page 3-39)
For 4008 HDF option, check additional measuring point!
TSC 8.1 Visual inspections performed according to item 1 – 
TSC 8.2 Protective earth resistance, maximum 0.3 Ω (with power cable) Ω 
TSC 8.3 Device leakage current measured – 
 Device leakage current – differential current measurement according to fig. 5
or
Nominal voltage of power supply: V
Device leakage current, mains polarity 1 μA
For line voltage V
Normalized to nominal voltage
For line voltage V
9 Functional checks
TSC 9.1 T1 Test completed – 


Remarks:
#FMESIG_3##

Date of next check:
Remarks:
#FMESIG_4##
Warning
A disinfection must be performed on completion of the checks.

3.2.3 Explanatory notes for completing the TSC / MA report
These checks must be performed every 24 months if all of the following requirements Interval:
have been met:  24 months
 Software:
(Please check)
4008 B system: from 4.951 to < 5.00 or with 5.201 or higher
 DIP switch PCB LP632 array 2 SW 5 set to OFF
 DIP switch PCB LP631 array 2 SW 7 set to ON
 DIP switch PCB LP631 array 2 SW 8 set to ON (With CDS option only)
If one of the requirements mentioned above has not been met, the checks have to be
performed every 12 months.
These inspections must be carried out by persons who are qualified to properly perform the specified
Technical Safety Checks owing to their educational background and training, their knowledge and
experience gained in practice, and who are not subject to any directions with regard to this inspection
activity.
TSC MA No. Description Desired value / function
TSC 1.1 Fuses accessible from the Must comply with the maximum permissible
outside values.
TSC 1.2 Labels and inscriptions Must be present and legible.
TSC 1.3 Mechanical condition Must permit further safe use.
TSC 1.4 Damage and contaminations There must not be any detectable damage or
contamination.
TSC 1.4.1 Rotors of the tube roller pumps The rotors show no signs of damage. Check the
rotors of the tube roller pumps.
– Rotors installed in the proper location and
1 identification present.
– Handle disks (3) tight and undamaged.
– Check all rollers (2) for smooth running.
2
– No mechanical damage on the guide
pulleys (1) and other parts of the rotors
(see drawing)
3 Damaged rotors must be replaced by new ones.
TSC 1.4.2 PCB LP 928 (CAN bus distributor Check PCB LP 928 with covering to verify the
board) with covering (only 4008 S following:
with E-Code 905 and lower) – There is no moisture.
– There is no precipitation.
– PCB LP 928 is not mechanically damaged in
any other way.
TSC 1.5 Power cable Must not be damaged.
MA 1.6 Preventive measures

MA 1.6.1 Replace the sealing in the concentrate / bicarbonate suction tubes and lubricate with
Unisilkon. Replace the rivet in the suction tubes, if necessary.
MA 1.6.2 Check the rubber in the rinse chambers for proper function.
MA 1.6.3 Retighten the rinse chamber (90a/90b) screws.
MA 1.6.4 Replace the check valve (92).

When using CDS, replace the check valves (117/118) and the filters 119/120.
MA 1.6.5 Replace the filter sieves; upstream of the UF pump (filter 74), downstream of MV43
(filter 76), between MV99 and rinse chamber (filter 149), between MV100 and rinse
chamber (filter 148).
MA 1.6.6 Replace the filter sieve in the dialyzer tube; replace the complete filter (73),
if necessary.
MA 1.6.7 Replace the O-rings in the dialyzer couplings.
MA 1.6.8 Check the tube in the sampling valve (116) dialysate circuit for proper function,
replace the complete valve, if necessary.
MA 1.6.9 Clean or replace the fan filter in the monitor.
MA 1.6.10 Check the air separation pump (97): replace the belt ribbon and the tube segment.
Observe direction of delivery.
MA 1.6.11 MV84 (yellow label) must be replaced after 2 years.

Only applicable when using Puristeril 340, Puristeril plus.
MA 1.6.12 Replace the connecting piece or equilibration chamber.

Only on devices where the ONLINEplus™ or DIASAFE® plus option is not used.
MA 1.6.13 Replace filter 210 (if present).
MA 1.6.14 Replace the disinfectant filter.
MA 1.6.15 Replace worn or dirty tubes.
MA 1.6.16 Every 4 years only: Change battery (ensure correct polarity!)
2 General checks
TSC 2.1 Power failure alarm Dialysis mode;

Continuous sound after removing the power plug.
Text displayed: Emergency operation
The extracorporeal blood circuit incl. all
monitoring functions is maintained.
TSC 2.2 Check level sensor Draw in air via the dialysate couplings.
The air separation pump is activated.
If more air is detected, the device will switch to
the fill program, depending on the dialysate flow.
Text displayed when the OD senses blood:
Fillprogram

TSC 2.3 Check DIP switches PCB LP 631 (CPU1) DIP switch array 2 SW7 is
set to ON.
PCB LP 631 (CPU1) DIP switch array 2 SW8 is
set to ON.

Check all pressures with undamped pressure gages!
MA 3.1 Check water inlet pressure Connect a pressure gage before MV41 to
(reduced) and correct if measuring point A in the hydraulic unit.
necessary When the valve MV41 is closed, the pressure
should range between 0.9 and 1.4 bar.
MA 3.2 Check the balancing chamber Connect a pressure gage to the pressure side of
loading pressure and correct, the degassing pump (measuring point B in the
if necessary hydraulic unit).
The pressure should be between 1.2 and 1.3 bar.
In case of the equipment codes
4008 B - EC495
4008 H - EC295
4008 S - EC275
and higher, the pressure must be 1.45 bar
±0.05 bar.
MA 3.3 Check the degassing pressure. Connect a pressure gage to the suction side of
the degassing pump (measuring point D in the
hydraulic unit).
Degassing pressure: –0.81 to –0.85 bar.
MA 3.4 Check the balancing chamber Connect a pressure gage to the pressure side of
relief pressure at a flow of the flow pump (measuring point C in the hydraulic
800 ml/min (relief valve 78). unit).
The relief pressure depends on the loading
pressure set (see MA 3.2):
Loading pressure: Relief pressure:
1.2 to 1.3 bar 1.9 to 2.1 bar
1.45 ±0.05 bar 2.2 ±0.05 bar
TSC 4.1 Check the delivery volume of the Collect 60 ml of dialysate in an appropriate
UF pump. measuring cylinder (see Chapter 4.3.5 on
page 4-24).
60 strokes = 60 ml ±0.5 ml
(59.6 g ±0.5 g dialysis water)
Correct the setting of the UF pump, if necessary.
MA 4.2 Test the concentrate pump Adjust according to calibration instructions,

volume or compare it with an if necessary.
appropriate reference.
MA 4.3 Test the bicarbonate pump Adjust according to calibration instructions,

volume or compare it with an if necessary.
appropriate reference.

5 Treatment
MA 5.1 Temperature Use a reference meter connected between the

dialyzer couplings to verify that the temperature
is 37 °C ±0.5 °C.
Correct any deviations with the calibration
program.
MA 5.2 Temperature display The temperature shown on the monitor front

(does not apply to 4008 B / panel must be 37 °C ±0.5 °C.
4008 S) Correct any deviations with the calibration
program.
MA 5.3 Dialysate pressure Perform a TMP test according to the calibration

instructions (see Part 14: Calibrating the
dialysate pressure (stainless steel pressure
transducer) on page 5-34).
TSC 5.4 Verify the conductivity display If the bibag® option is used, connect a bibag®!
Measure the conductivity with a reference meter
connected between the dialyzer couplings.
The conductivity measured must agree with the
value on the device.
program.
MA 6.1 Arterial pressure transducer Check the slope of the pressure transducer.
After applying a pressure of approx. 200 mmHg
to the pressure transducer, the value displayed
must agree with the reading shown on the
external reference meter (tolerance ±10mmHg).
program.
MA 6.2 Venous pressure transducer Check the slope of the pressure transducer.
After applying a pressure of approx. 300 mmHg
to the pressure transducer, the value displayed
on the device must agree with the reading shown
on the external reference meter (tolerance
±10 mmHg).
program.
TSC 6.3 Arterial and Single Needle blood Check the blood pump rate (calibration program:
pump rate BP-Rate CHECK).
TSC 6.4 SN switching points Check the switching points according to the table
in the Technical Manual.
TSC 6.5 Check the blood pump stop Opening the blood pump door will trigger the
alarm. blood pump stop alarm after 30 s (factory
setting).
TSC 6.6 Level detector In the event of a blood alarm, the venous tube
clamp must close.

TSC 6.7 Level detector Generate pressure of about 2 bar in the venous
bubble catcher.
Ensure that the pressure does not drop by more
than 0.1 bar within 3 minutes (see Chapter 4.4
on page 4-30).
7 Options
7.1 bibag®
MA 7.1.1 Replace bibag® connector O-rings.
MA 7.1.2 PSW 134 Check the switching pressure. The maximum

switching pressure is 130 mbar + 30 mbar.
7.2 DIASAFE
MA 7.2.1 DIASAFE filter life Check the filter life.

Filter life: 12 weeks
MA 7.2.2 Hydrophobic filter 111 Replace the filters.
MA 7.2.3 O-rings in the DIASAFE’s Replace the O-rings.

dialysate couplings
7.3 DIASAFE® plus
MA 7.3.1 Filter life of the DIASAFE® plus Check the filter life.
Filter life: 12 weeks
7.4 4008 HDF
TSC 7.4.1 Check the delivery rate of the 2nd Collect 60 ml of dialysate in an appropriate
UF pump. measuring cylinder (see Chapter 4.3.5 on
page 4-24).
60 strokes = 60 ml ±0.5 ml
(59.6 g ±0.5 g dialysis water)
If necessary, correct the value.
MA 7.5.1 Filter life of DIASAFE and Check the filter life.

ONLINE filter Filter life of the DIASAFE:
12 weeks
Filter life of the ONLINE filter:
8 weeks or 50 treatments
MA 7.5.3 O-rings in the DIASAFE’s Replace the O-rings.

dialysate couplings
MA 7.5.4 HDF pump rotor Check the rotor for smooth running and wear.
MA 7.5.5 Fastening strap Check the fastening strap for Luer-lock.

TSC 7.5.6 Substituate pump with DC motor: Speed 150 ml/min

To determine the delivery volume:
the volume of fluid delivered must agree with the
preset value (±10%).
To check the speed:
with the above setting the blood pump rotor must
turn at 13.5 rpm.
(See Technical Manual ONLINE-HDF,
chapter 3).
or
Substituate pump with stepper Check the pump rate.

motor (Calibration program: BP-Rate CHECK)
TSC 7.5.7 Substituate pump stop Stop the substituate pump by

– Triggering a blood alarm
– Triggering the bypass function
– Opening the blood pump cover
TSC 7.5.8 Substituate pump function
– Rinse Start the rinse program,

the pump will deliver at 400 ml/min.
– Hot rinse Start the hot rinse program,

– Disinfection Start the disinfection program,

MA 7.6.1 Filter life of DIASAFE® plus and Check the filter life
ONLINEplus™ filters Filter life of DIASAFE® plus and ONLINEplus™
filters: 12 weeks or 100 treatments
MA 7.6.2 Hydrophobic filters 111 and 184 Replace the filters.
MA 7.6.3 Substituate port (195) and rinse Replace the O-rings. Grease the O-rings with
port (194) Unisilkon grease before installation.
TSC 7.6.4 Line pinch valve 193 (ONL1) Replace the tube.
TSC 7.6.5 Check of DIP switch With HPU (hydraulic processing unit)
PCB LP632 (CPU2) DIP switch array 2 switch 5
is set to OFF.
7.7 OCM (4008 H / 4008 S only)
MA 7.7.1 OCM temperature / conductivity compensation test (TEMP/CD.COMP Test):

Compare the conductivity values of the CD cells 7 and 110 with each other. If the
values deviate by more than ±0.05 mS/cm, an OCM PULSE calibration has to be
performed.

7.8 BPM 4008

The Technical Measurement Checks (TMC) additionally stipulated for specific
countries form part of the Technical Safety Checks (TSC).
MA 7.8.1 Labels and inscriptions Must be present and clearly legible. Check of the
actual condition.
MA 7.8.2 Mechanical condition Must permit further safe use.
MA 7.8.2.1 Check whether the tube connector is correctly attached to the device.
MA 7.8.2.2 Check whether the internal blood pressure module, the printed circuit boards, and all
cable connections are correctly fixed.
MA 7.8.2.3 Replace damaged tubes or cuffs.
MA 7.8.2.4 Display elements Visual and audible functional checks after

turn-on.
(See Instructions for Use BPM 4008, chapter 2.2)
MA 7.8.2.5 Touch panel Check whether the touch panel is functioning

correctly.
TSC 7.8.3 Leakage test Perform the leakage test with the cuff and
TMC pressure tube connected. The pressure leakage
rate must be less than 6 mmHg/min.
(See Technical Manual BPM 4008, chapter 3.1)
TSC 7.8.4 Calibration Calibration:

TMC Tolerance of pressure values:
250 mmHg ±3 mmHg
200 mmHg ±3 mmHg
150 mmHg ±3 mmHg
100 mmHg ±3 mmHg
050 mmHg ±3 mmHg
TSC 7.8.5 Safety valve Check the safety valve.

TMC The system must be discharged at 320 mmHg
± 10 mmHg.
TSC 7.8.6 Blood pressure measurement Measure the blood pressure in manual mode.
TMC Check the results for plausibility.
7.9 BTM 4008
7.10 BVM 4008

TSC 8.1 Visual inspections performed see item 1 Visual inspections

TSC 8.2 Protective earth resistance Maximum 0.3 Ω (with power cable)
TSC 8.3 Measurement of the device leakage current performed

Device leakage current – differential current measurement according to fig. 5
or
Device leakage current – direct measurement according to fig. 4
Basic requirements for the differential current measurement according to fig. 5:

– Measurement of the protective earth resistance has been completed.
– Dialysate:

Basic requirements for the direct measurement according to fig. 4:

– The device must be insulated when installed.
– All external connections must have been removed from the device.
– Do not touch the device while the measurement is in progress.
– Measurement of the protective earth resistance has been completed.
– Dialysate:
Nominal voltage of the power supply:

– Document the nominal voltage of the power supply.

– Measure and document the maximum device leakage current and the current line
voltage at mains polarity 1.
– Normalize the device leakage current at mains polarity 1 to the nominal voltage of
the power supply and document it.

– Measure and document the maximum device leakage current and the current line
voltage at mains polarity 2.
– Normalize the device leakage current at mains polarity 2 to the nominal voltage of
the power supply and document it.
Check the measurements:

– Check the normalized device leakage current at mains polarity 1, taking the
Additional conditions into account.
– Check the normalized device leakage current at mains polarity 2, taking the
Additional conditions into account.
Example 1 – measurements normalized and checked:

Nominal voltage of the power supply: 230 V
(180 µA : 225 V x 230 V = 184 µA).
(198 µA : 220 V x 230 V = 207 µA).

Additional conditions:
If the value of the leakage current normalized to the nominal voltage is higher than
90% of the alarm limit (450 µA), the last measured value or the first measured value
must additionally be considered for the rating.
If the device leakage current has considerably increased since the last measurement
or has continuously increased since the first measurement (slow deterioration of the
insulation), or if the sum composed of the current value plus the difference since the
last measurement is > 500 µA, the measurement is considered "not passed".
Example 2 – Additional conditions passed:
470 µA + (470 µA – 450 µA) = 470 µA + 20 µA = 490 µA: passed.
Example 3 – Additional conditions not passed:
470 µA + (470 µA – 390 µA) = 470 µA + 80 µA = 550 µA: not passed.
9 Functional check
TSC 9.1 Perform the functional test Press Test key.

The system must successfully pass the T1 test.
Warning

3.2.3.1 Notes – Check of the electrical safety
 Test 4008 H
1. Protective earth resistance measuring points
1
2
3
4
6
7
Legend
2 Monitor rear panel (ports housing)
4 Monitor rear panel (plate)
5 Power supply plate
7 Hydraulic unit rear panel (plate on the push-on blade inside)
Caution: The grounding cable must be connected.
8 Dialyzer tube ports
(hydraulic unit open / earthing screw)
9 Bonding stud
2. Use a measuring instrument (e.g., SECUTEST) to check the leakage current.

 Test 4008 B, 4008 S
1. Protective earth resistance measuring points
Legend
2 Heat sink power supply unit
If in place: outward measurement point (screw head) at bottom right on the rear of the device
4 Dialyzer tube ports (adapters)
5 Bonding stud

 Test 4008 HDF (option)
1. Protective earth resistance measuring point
Protective earth resistance measuring point
3. Measurement conditions
The measurements must be taken in the dialysis mode in the "ON phase" of the heater control system.
The scales must be moved out to such an extent that neither of the two end switches are actuated (middle
position).
3.2.4 TSC report
TSC / MA report The TSC / MA report (see TSC / MA report on page 3-25) and the
TSC report TSC report (see TSC report on page 3-42) differ in the following points:
– Maintenance procedures (MA)
– Category TSC or MA in first column

4008 B / 4008 H /
TSC report
4008 S
These checks must be performed every 24 months if all of the following requirements have been met: Interval:
 Software:  12 months
4008 B system: from 4.951 to < 5.00 or with 5.201 or higher (Please check)
 DIP switch PCB LP632 array 2 SW 5 set to OFF.
 DIP switch PCB LP631 array 2 SW 7 set to ON.
 DIP switch PCB LP631 array 2 SW 8 set to ON. (With CDS option only)
every 12 months.
Name of technician Service report no.:
Serial number: Inventory no.: Operating hours:
Device type:  4008 B  4008 H  4008 S

With option:  DIASAFE® plus  OCM  ONLINEplus™  SN  bibag®
 BPM  BTM  BVM  DIASAFE  ONLINE HDF  4008 HDF

1.1 Fuses accessible from the outside comply with the specified values – 
1.2 Labels and inscriptions are present and legible – 
1.3 Mechanical condition permits further safe use – 
1.4 There are no signs of damage or contamination – 
1.4.1 No signs of damage on the tube roller pump rotors – 
1.4.2 PCB LP 928 (CAN bus distributor) with covering checked (only 4008 S with E-Code 905 and lower) – 
1.5 Power cable not damaged – 
2 General checks
2.1 Power failure alarm – continuous sound – text displayed: Emergency operation – 
2.2 Air separation by air separation pump activated; text displayed if more air must be separated and OD senses – 
blood: Fill program
2.3 Check DIP switches – 
4.1 UF pump, 1 stroke = 1 ml, 
5 Treatment
5.4 Conductivity display checked with reference meter
If the bibag® option is used, connect a bibag®!
– CD device 
– CD ref. 
6.3 Blood pumps: Check of blood pump rate (calibration program: BP-Rate CHECK) – 
6.4 SN switching pressure checked according to table in the Technical Manual – 
6.5 Blood pump stop alarm checked – 
6.6 Venous tube clamp closes after blood alarm. – 
6.7 Pressure of approx. 2 bar in the venous bubble catcher. – 


7 Options
7.4 4008 HDF
7.4.1 2nd UF pump, 1 stroke = 1 ml, 
7.5.6 Substituate pump – 
 with DC motor: Pump adjusted Desired /
or actual:
/
 with stepper motor: Pump rate checked (calibration program: HDF-Pump-Rate Check)
7.5.7 Substituate pump stop
– Following blood alarm – 
– After triggering the bypass function – 
– After opening the blood pump door – 
7.5.8 Check substituate pump for proper function:
– Rinse program, delivery rate: 400 ml/min – 
– Hot rinse program, delivery rate: 150 ml/min – 
– Disinfection program, delivery rate: 400 ml/min – 
7.6.4 Tube in the tube pinch valve 193 (ONL1) replaced – 
7.6.5 Check of DIP switch – 
PCB LP632 (CPU2) DIP switch array 2 switch 5 is set to OFF in HPU (hydraulics processing unit)
7.8 BPM 4008
The Technical Measurement Checks (TMC) additionally stipulated for specific countries form part of the Technical Safety
Checks (TSC).
7.8.3 Leakage test: Pressure leakage rate less than 6 mmHg/min – 
7.8.4 Calibration:
Pressure valuesTolerance
7.8.5 Safety valve: Drained at 320 mmHg, ±10 mmHg – 
7.8.6 Blood pressure measurement performed – 
For 4008 HDF option, check additional measuring point!
8.1 Visual inspections performed according to item 1 – 
8.2 Protective earth resistance, maximum 0.3 Ω (with power cable) Ω 
8.3 Device leakage current measured – 
 Device leakage current – differential current measurement according to fig. 5
or
Nominal voltage of power supply: V
For line voltage V
For line voltage V
9 Functional checks
9.1 T1 Test completed – 



Remarks:
#FMESIG_5##

Date of next check:
Remarks:
#FMESIG_6##
Warning

3.3 Decommissioning
3.3.1 Important information on decommissioning
Precautions for working on Before working on the device, first read the information in the following
the device chapter (see Chapter 1.4 on page 1-2).
Decommissioning Decommissioning is the conscious removal of a device from routine

operation. The decommissioning is valid for a maximum
decommissioning period of 12 months.
Performance of decommissioning must be entered in the medical
device register.
Warning
3.3.2 Articles required to perform decommissioning
Article Description
4008 decommissioning kit For decommissioning of a device.
Syringe For filling the device with a defined quantity of fluid.
3.3.3 Decommissioning report and identification sheet

4008 B / 4008 H /
Decommissioning report
4008 S


1 Cleaning / Disinfection
1.1 Surfaces disinfected Off – 
1.2 Disinfection program completed Cleaning – 
1.3 Equilibration chamber (option) / DIASAFE® plus (option) / ONLINEplus™ Cleaning – 
(option) removed and shunt interlocks inserted
2 Rinsing Free TIME
2.1 Rinsing Free TIME value checked / adjusted SETUP MENU  Yes Min. 
– Without CDS (option): Rinsing Free TIME ≥ 4 minutes  No
– With CDS (option): Rinsing Free TIME 6 minutes
3 Central Delivery System (option)
3.1 Central Acid Delivery System (option)
3.1.1 CDS tube removed SETUP MENU – 
3.1.2 Select the Central Acid in the SETUP MENU  SET CENTRAL-DELIVERY. SETUP MENU – 
3.1.3 100 ml antifreeze filled via CDS connector CALIBRATION – 
3.1.4 CDS connector closed off with plug CALIBRATION – 
3.2 Central Bicarbonate Delivery System (option)
3.2.1 CDS tube removed SETUP MENU – 
3.2.2 Select the Central Bic field in the SETUP MENU  SET CENTRAL- SETUP MENU – 
DELIVERY.
3.2.3 100 ml antifreeze filled via CDS connector CALIBRATION – 
3.2.4 CDS connector closed off with plug CALIBRATION – 
4 Disinfectant connector
4.1 50 ml antifreeze filled via disinfectant connector DIAGNOSTICS – 
4.2 Disinfectant connector closed off with plug DIAGNOSTICS – 
5 Hydraulics
5.1 Service switch set to ON (heater off) after starting up the device On – 
5.2 Tubing set from 4008 decommissioning kit connected and inserted On – 
5.3 Cleaning program Cleaning (front supplied) started Cleaning – 
5.4 Antifreeze filled using the arterial blood pump Preparation – 
5.5 Antifreeze drawn in via concentrate suction tube after message Connect Preparation – 
Disinfectant
5.6 Concentrate suction tube inserted into the rinse chamber following message Preparation – 
Disinfectant empty ? or Conc line not connected
6 Final procedures
6.1 All connections closed off with plugs Off – 
6.2 Date of decommissioning documented Off 
6.3 End of decommissioning validity recorded Off 
6.4 Identification sheet attached to device Off – 
Antifreeze used:
(Durability assured throughout decommissioning period):
#FMESIG_7##

Identification sheet
Decommissioned device
This device has been decommissioned and filled with antifreeze.
Treatments are prohibited.
The decommissioning of this device may only be revoked by the service support organization.
Device serial number:
Antifreeze used:
Date of decommissioning:
Validity of decommissioning:
Note
Battery discharge
The rechargeable battery must also be maintained while a system is
decommissioned.
 Follow Instructions for Use.

3.3.4 Explanatory notes on the decommissioning report and identification sheet

work.
Service report no.:
 Document name and/or number of end customer.
Serial no.:
 Document the serial number as shown on the identification label in
the report.
 Document the serial number as shown on the identification label on
the identification sheet.
Inventory no.:
Operating hours:
 Document the operating hours, if a time meter is installed.
Equipment code:
(e.g., EC xxx, E-Code xxx).
Re 1 Cleaning / Disinfection
Re 1.1 Surfaces disinfected

 Disinfect surfaces with a surface disinfectant approved by the
manufacturer.

Operating state: Cleaning
 Press Disinfection key or Cleaning key.
 Select the disinfection program.
 Press the Conf key if necessary.
 Run the full disinfection program.

Re 1.3 Equilibration chamber (option) / DIASAFE® plus (option) /

ONLINEplus™ (option) removed and shunt interlocks inserted
 Remove the equilibration chamber (option) / DIASAFE® plus
(option) / ONLINEplus™ (option).
 Insert shunt interlocks in filter holder.
Re 2 Rinsing Free TIME
Re 2.1 Rinsing Free TIME value checked / adjusted

Operating state: SETUP MENU
 Go to the SETUP MENU  SETUP CLEANING PGM  CLEANING
Times and select the field Rinsing Free TIME.
 Check the Rinsing Free TIME and adjust if necessary.
Desired value without CDS (option): Rinsing Free TIME ≥ 4 minutes
Desired value with CDS (option): Rinsing Free TIME 6 minutes
Re 3 Central Delivery System (option)
Re 3.1 Central Acid Delivery System (option)
Re 3.1.1 CDS tube removed

 Remove the CDS tube.
Re 3.1.2 The central Acid field is selected

 Select the Central Acid in the SETUP MENU  SET CENTRAL-
DELIVERY.
Re 3.1.3 100 ml antifreeze filled via CDS connector

 Press the Flow key to turn on the dialysate flow.
 Unlock the bicarbonate suction tube.
 Connect a syringe filled with antifreeze to the CDS connector and fill
100 ml of antifreeze.
 Lock the bicarbonate suction tube.
Re 3.1.4 CDS connector closed

 Close off the CDS connector with a plug.

Re 3.2 Central Bicarbonate Delivery System (option)
Re 3.2.1 CDS tube removed

 Remove the CDS tube.
Re 3.2.2 The central Bic field is selected

 Select the Central Bic field in the SETUP MENU  SET CENTRAL-
DELIVERY.
Re 3.2.3 100 ml antifreeze filled via CDS connector

 Unlock the concentrate suction tube.
 Connect a syringe filled with antifreeze to the CDS connector and fill
100 ml of antifreeze.
 Lock the concentrate suction tube.
Re 3.2.4 CDS connector closed

 Close off the CDS connector with a plug.
Re 4 Disinfectant connector
Re 4.1 50 ml antifreeze filled via disinfectant connector

Operating state: DIAGNOSTICS
 Connect a syringe filled with antifreeze to the disinfectant connector.
 Go to the DIAGNOSTICS  WRITE OUTPUTS  WRITE DIGIT.
OUTPUTS  CPU1: WR DIGIT. OUTP menu. Use the +/- key to set
valves V43, V84, V87 to 1111.
 Fill 50 ml of antifreeze.
Valve V84 must be closed before the syringe can be withdrawn. The
fluid might leak out.
valve V84 to 0000.
 Remove the syringe.
Re 4.2 Disinfectant connector closed off with plug

 Close off the disinfectant connector with a plug.
 Turn the device off.
 Set the service switch to OFF (treatment).

Re 5 Hydraulics
Re 5.1 Service switch set to ON (heater off) after starting up the device
Operating state: On
 Turn the device on.
 Set the service switch to ON (Service mode) after starting up the
device.
The heater is deactivated.
Re 5.2 Tubing set from 4008 decommissioning kit connected and

inserted
Operating state: On
Fig.: Tubing set of the 4008 decommissioning kit (sample)
 Connect the tubing set (1) to the tubing connector (2).

 Disconnect the dialysis water inlet tube (3) from the dialysis water
supply.

 Connect the dialysis water inlet tube (3) to the tubing connector (2).
 Secure the tubing set (1) and dialysis water inlet tube (3) with tube
clips.
 Insert the tubing set (1) into the arterial blood pump as shown.
 Connect the suction side of the tubing set (4) to the suction tube of
the 4008 decommissioning kit.
 Close off the tube (5).
 Place the suction tube in the antifreeze canister (6).
Re 5.3 Cleaning program Cleaning (front supplied) started

 Press the Cleaning key.
 Select the Cleaning (front supplied) field.
Re 5.4 Antifreeze filled using the arterial blood pump

 Press and hold down the Preparation key for about 1 second.
Arterial blood pump active.
 Set the arterial blood pump rate to 600 ml/min.
 Ignore the message Water alarm.
 Press and hold down the Preparation key for about 1 second when
the arterial blood pump stops.
 Set the arterial blood pump rate repeatedly to 600 ml/min.
Re 5.5 Antifreeze drawn in via concentrate suction tube after message

Connect Disinfectant.
 Stop the arterial blood pump.
 Insert the concentrate suction tube into the antifreeze canister when
the Connect Disinfectant message is displayed.
 Press the Conf key.
Antifreeze is drawn in via the concentrate suction tube.
Re 5.6 Concentrate suction tube inserted into the rinse chamber

following message Disinfectant empty ? or Conc line not
connected
 Insert the concentrate suction tube into the concentrate rinse
chamber when the Disinfectant empty ? or Conc line not
connected messages appear.
 Turn the device off.

Re 6 Final procedures
Re 6.1 All connections closed off with plugs

 Remove the tubing set of the 4008 decommissioning kit.
 Remove the dialysis water inlet tube.
 Remove the water outlet tubing.
 Close off the dialysis water inlet, water drain, and overflow with
plugs.
Re 6.2 Date of decommissioning documented

 Document the date of decommissioning in the report.
 Document the date of decommissioning on the identification sheet.
Re 6.3 End of decommissioning validity recorded

 Document the validity of decommissioning in the report.
 Document the validity of decommissioning on the identification
sheet.
Re 6.3 Identification sheet attached to device

 Document the antifreeze used on the identification sheet.
 Attach the identification sheet in a visible location on the device.
Confirmation of Antifreeze used:

decommissioning
 Document the antifreeze used in the report.
 Make sure the durability of the antifreeze is assured throughout the
decommissioning period.
 Confirm decommissioning with date, tester’s signature, and stamp.

3.4 Decommissioning extension
3.4.1 Important information on decommissioning extension
Decommissioning An existing decommissioning period can be extended by further periods

extension of 12 months. The existing decommissioning period must be extended
before the end of the 12th month following decommissioning.
Decommissioning extension must be entered in the medical device
register.
Warning
3.4.2 Articles required to perform decommissioning extension
Article Description
4008 decommissioning kit For decommissioning of a device.
3.4.3 Decommissioning extension report

4008 B / 4008 H /
Decommissioning extension report
4008 S


1 Recommissioning
1.1 Recommissioning carried out (Recommissioning – – 
(existing decommissioning period ended) report)
2 Decommissioning
2.1 Decommissioning carried out (Decommissioning – – 
(new decommissioning period started) report)
#FMESIG_8##

3.4.4 Explanatory notes for completing the decommissioning extension report

work.
Service report no.:
Serial no.:
 Document the serial number as shown on the identification label in
the report.
 Document the serial number as shown on the identification label on
the identification sheet.
Inventory no.:
Operating hours:
Equipment code:
Re 1 Recommissioning
Re 1.1 Recommissioning carried out

(existing decommissioning period ended)
Operating state: (see Recommissioning report after
decommissioning on page 3-59)
 Carry out recommissioning (see Chapter 3.5 on page 3-58).
When extending the decommissioning period, the equilibration
chamber (option) / DIASAFE® plus (option) / ONLINEplus™ (option)
does not have to be inserted.
Re 2 Decommissioning
Re 2.1 Decommissioning carried out

(new decommissioning period started)
Operating state: (see Decommissioning report on page 3-46)
 Carry out decommissioning (see Chapter 3.3 on page 3-45).

Confirmation of Date, signature, stamp:

decommissioning
 Confirm decommissioning with date, tester’s signature, and stamp.
extension

3.5 Recommissioning after decommissioning
3.5.1 Important information on recommissioning after decommissioning
Warning
When the device is recommissioned into operation, check that the
pressure of the dialysis water (permeate) supply meets the prescribed
minimum pressure.
Recommissioning Recommissioning is the process of preparing a device to return to

routine operation after preservation with antifreeze.
Recommissioning must be entered in the medical device register.
Warning
3.5.2 Articles required to perform recommissioning after decommissioning
Article Description
3.5.3 Recommissioning report after decommissioning

4008 B / 4008 H / Recommissioning report after

4008 S decommissioning


1 Preparation
1.1 Identification sheet removed Off – – 
1.2 Plugs removed from all connectors Off – – 
1.3 Dialysis water inlet tube and water drain tube connected Off – – 
2 Disinfectant connector
2.1 100 ml dialysis water filled via disinfectant connector DIAGNOSTICS – – 
3 Central Delivery System (option)
3.1 Central Acid Delivery System (option)
3.1.1 200 ml dialysis water filled via CDS connector CALIBRATION – – 
3.2 Central Bicarbonate Delivery System (option)
3.2.1 200 ml dialysis water filled via CDS connector CALIBRATION – – 
4 Hydraulics
4.1 Concentrate suction tube and bicarbonate suction tube unlocked CALIBRATION – – 
4.2 800 ml/min dialysate flow turned on for 3 minutes CALIBRATION – – 
4.3 Concentrate suction tube and bicarbonate suction tube locked CALIBRATION – – 
5 Cleaning / Disinfection
5.1 Mandatory rinse performed Cleaning – – 
5.2 Filter change performed Cleaning – – 
5.3 Disinfection program completed Cleaning – – 
6 Functional check
6.1 T1 Test completed T1 test – – 
7 Technical Safety Checks
7.1 Technical Safety Checks (TSC) performed (TSC report) – – 

Date of next check:
Remarks:
#FMESIG_9##
Warning
On completion of these procedures it is imperative to run a disinfection.

3.5.4 Explanatory notes for completing the recommissioning report after

decommissioning

work.
Service report no.:
Serial no.:
 Document the serial number, as shown on the identification label.
Inventory no.:
Operating hours:
Equipment code:
Re 1 Preparation
Re 1.1 Identification sheet removed

 Remove the identification sheet from the device.
Re 1.2 Plugs removed from all connectors

 Remove the plugs from the following connectors:
– Dialysis water inlet port
– Water drain
– Overflow
– Disinfectant connector
Re 1.3 Dialysis water inlet tube and water drain tube connected
 Connect the dialysis water inlet tube.
 Connect the water drain tubing.

Re 2 Disinfectant connector
Re 2.1 100 ml dialysis water filled via disinfectant connector

 Connect a syringe filled with dialysis water to the disinfectant
connector.
valves V43, V84, V87 to 1111.
 Fill 100 ml of dialysis water.
Valve V84 must be closed before the syringe can be withdrawn. The
fluid might leak out.
valve V84 to 0000.
 Remove the syringe.
Re 3 Central Delivery System (option)
Re 3.1 Central Acid Delivery System (option)
Re 3.1.1 200 ml dialysis water filled via CDS connector

 Remove the plug from the CDS connector.
 Select the Central Acid in the SETUP MENU  SET CENTRAL-
DELIVERY.
 Connect a syringe filled with dialysis water to the CDS connector.
 Adjust the SETUP MENU  SET CENTRAL-DELIVERY according
to the customer's requirements.
 Connect the CDS tube if necessary.

Re 3.2 Central Bicarbonate Delivery System (option)
Re 3.2.1 200 ml dialysis water filled via CDS connector

 Remove the plug from the CDS connector.
 Select the Central Bic field in the SETUP MENU  SET CENTRAL-
DELIVERY.
 Connect a syringe filled with dialysis water to the CDS connector.
 Adjust the SETUP MENU  SET CENTRAL-DELIVERY according
to the customer's requirements.
 Connect the CDS tube if necessary.
Re 4 Hydraulics
Re 4.1 Concentrate suction tube and bicarbonate suction tube unlocked

Re 4.2 800 ml/min dialysate flow turned on for 3 minutes

 Select the CALIBRATION menu  CAL. FLOW 800 ml/min.
If necessary, message: DIASAFE-filling act.
Message: Fill program active
 Leave the dialysate flow on for at least 3 minutes.
Re 4.3 Concentrate suction tube and bicarbonate suction tube locked

Re 5 Cleaning / Disinfection
Re 5.1 Mandatory rinse performed

 Select the field Mandatory rinse.

Re 5.2 Filter change performed

 Select the field Filter change (option).
Message: Emptying filter.
Message: Filter changed ?
 Remove the shunt interlocks.
 Insert the equilibration chamber (option) / DIASAFE® plus
(option) / ONLINEplus™ (option).
 Press the Conf key.

 Run the disinfection program.
Re 6 Functional check
Re 6.1 T1 Test completed

Operating state: T1 test
 Start T1 Test.
 Wait until the T1 test has been successfully completed.
Re 7 Technical Safety Checks
Re 7.1 Technical Safety Checks (TSC) performed

Operating state: (see TSC report on page 3-42)
 Perform Technical Safety Checks (see Chapter 3.2 on page 3-23).
Confirmation of The device is released for its intended use (attach inspection label)
recommissioning
There must be no risk to patients, staff, or third parties during the
intended use of the device.
Within the scope of the overall assessment, the tester must make a
definite decision as to whether or not the device may be used. The
responsible organization must be informed without delay of any defects
detected.
 Decide whether or not the system can be released for its intended
purpose.
 Inform the responsible organization of any defects in the device
without delay.
Date of next check:
 Document the date of the next test in the report.
 Respect the intervals specified by the manufacturer.

Remarks:
 Record any irregularities which influenced your assessment.
 Confirm recommissioning with date, tester's signature and stamp.
3.6 Removal from service
3.6.1 Important information on removal from service
Removal from service Removal from service is the definitive withdrawal of a device from
routine operation. Instructions for removal from service and disposal are
given in the latest applicable Instructions for Use, and must be followed.
Removal from service must be entered in the medical device register.

Chapter 4: Adjustment instructions
4 Adjustment instructions
 Test equipment and accessories
HMED pressure gage with case (set)
UMED universal measuring instrument with

case (set)
(conductivity, pressure, temperature)

Secutest for testing electrical safety (with

optional printer module)
Carrying case (not illustrated)
Adjustment set for 22 mm level detector
Service Software set 4008

Electronic pocket scales

Test weight with spirit level and certificate
Graduated cylinder 100 ml
Special tool for installation and removal of

modules

ESD service kit
ESD work station kit
IC extractor tool
The current list of the test equipment and accessories with part numbers can be found in the electronic
Spare Pars Catalog.

Fig.: Hydraulics flow diagram with DIASAFE® plus (optional) without HPU (basic hydraulics)
CDS - Option
ZKV - Option

Legend

5 Float switch 102 Central conc. delivery valve
6 Level sensor 104 Central bic. delivery valve
7 Conductivity cell 109 Temperature sensor
8 Blood leak detector 111 Hydrophobic filter (advanced hydraulics)
9 Pressure transducer 112 Vent valve (advanced hydraulics)
10 Reed contact for concentrate 114 Dialysate filter (option DIASAFE® plus)
12 Reed contact for bicarbonate 115 Disinfection valve sensor
21 Flow pump 116 Fluid sample valve
22 UF pump 117 Check valve (concentrate)
23 Concentrate pump 118 Check valve (bicarbonate)
24 Dialyzer valve 1 119 Filter (concentrate)
24b Dialyzer valve 2 120 Filter (bicarbonate)
25 Bicarbonate pump 121 Central conc. delivery connection
26 Bypass valve 122 Central bic. delivery connection
29 Degassing pump 123 Pressure switch for V102
30 Outlet valve 124 Pressure switch for V104
32 Balancing chamber valve 2 131 bibag® block
33 Balancing chamber valve 3 131a bibag® air separation chamber
34 Balancing chamber valve 4 131b bibag® mixing chamber
38 Balancing chamber valve 8 135 bibag® level sensor
41 Water inlet valve 136 bibag® connector
43 Fill valve 137 bibag® microswitch 1
54 Heater rod 138 bibag® microswitch 2
61 Pressure reducing valve 148 Filter (rinse valve 100)
63 Filter / water inlet 149 Filter (rinse valve 99)
65 Loading pressure valve 151 Orifice
66 Heater block 210 Filter (degassing orifice)
66a Water inlet chamber
66b Heater rod chamber Hydraulics measuring points
66c Float chamber
68 Balancing chamber A Reduced water inlet pressure
71 Filter / concentrate B Balancing chamber loading pressure
72 Filter / bicarbonate C Flow pump pressure
73 Filter / external dialysate D Degassing pressure
74 Filter / UF
75 External flow display
76 Filter / fill valve
77 Heat exchanger
78 Relief valve
84 Disinfectant valve
85 Disinfectant connection
86 Recirculation valve
87 Drain valve
90a Rinse chamber, concentrate
91 Rinse valve
92 Vent valve
94 Concentrate suction tube
95 Bicarbonate suction tube
97 Air separation pump

Fig.: Hydraulics 4008 flow diagram with HPU (advanced hydraulics)

Legend
2 Temperature sensor 97 Air separation pump

4 Temperature sensor (OCM option) 100 Rinse valve
5 Float switch 102 Central conc. delivery valve
6 Level sensor 104 Central bic. delivery valve
7 Conductivity cell 109 Temperature sensor
8 Blood leak detector 110 Conductivity cell (OCM option)
9 Pressure transducer 111 Hydrophobic filter (advanced hydraulics)
10 Reed contact for concentrate 112 Vent valve (advanced hydraulics)
12 Reed contact for bicarbonate 114 Dialysate filter (option DIASAFE® plus)
21 Flow pump 115 Disinfection valve sensor
22 UF pump 116 Fluid sample valve
23 Concentrate pump 117 Check valve (concentrate)
24 Dialyzer valve 1 118 Check valve (bicarbonate)
24b Dialyzer valve 2 119 Filter (concentrate)
25 Bicarbonate pump 120 Filter (bicarbonate)
26 Bypass valve 121 Central conc. delivery connection
29 Degassing pump 122 Central bic. delivery connection
30 Outlet valve 123 Pressure switch for V102
32 Balancing chamber valve 2 125 Temperature compensation plate
37 Balancing chamber valve 7 136 bibag® connector
38 Balancing chamber valve 8 137 bibag® microswitch 1
39 Negative pressure valve 138 bibag® microswitch 2
41 Water inlet valve 148 Filter (rinse valve 100)
43 Fill valve 149 Filter (rinse valve 99)
54 Heater rod 151 Orifice
61 Pressure reducing valve 182 Pressure transducer 2 (advanced hydraulics)
63 Filter / water inlet 183 Test valve (advanced hydraulics)
65 Loading pressure valve 184 Hydrophobic filter
66 Heater block 185 Compressor (advanced hydraulics)
66a Water inlet chamber 188 Evacuation valve
66b Heater rod chamber 189 Retentate valve
66c Float chamber 190 Online filter (option ONLINEplus™)
68 Balancing chamber 191 Online 3 valve (option ONLINEplus™)
71 Filter / concentrate 192 Online 2 valve (option ONLINEplus™)
72 Filter / bicarbonate 193 Online 1 valve (option ONLINEplus™)
73 Filter / external dialysate 194 Rinse port (option ONLINEplus™)
74 Filter / UF 195 Substituate port (option ONLINEplus™)
75 External flow display 201 Air separator / concentrate
76 Filter / fill valve 202 Level sensor / concentrate
77 Heat exchanger 203 Air separator / bicarbonate
78 Relief valve 204 Level sensor / bicarbonate
84 Disinfectant valve 205 Mixing point, concentrate / bicarbonate
85 Disinfectant connection 210 Filter (degassing orifice)
86 Recirculation valve
87 Drain valve
90a Rinse chamber, concentrate Hydraulics measuring points
91 Rinse valve A Reduced water inlet pressure
92 Vent valve B Balancing chamber loading pressure
94 Concentrate suction tube C Flow pump pressure
95 Bicarbonate suction tube D Degassing pressure

Fig.: PCB overview
Rear Panel Rückplatte
LP 636
LP 630
LP 632 LP 633 LP 634

1
SW1
DIP-SW1
P1 Current Increasing
1 Stromerhöhung
SW2
DIP-SW2
P3 TMP-Gain
TMP-Steilheit
(LP 763)
SH1
DIP-SW2
SH2
DIP-SW1
LP 631
Alpha-Display (4008B)
Display board 4008B: LP 649; 4008H: LP 924; 4008S: LP 922
Front Panel / Mounting Plate Frontplatte / Montageplatte
Legend
PCB LP630 Motherboard

PCB LP631 CPU1 (operating system)
PCB LP632 CPU2 (protection system)
PCB LP633 Input board
PCB LP634 Output board
PCB LP636 External connectors
PCB LP649 Display board 4008 B
PCB LP763 Interface board
PCB LP924 Display board 4008 H
PCB LP922 Display board 4008 S

4.1 Overview of the DIP switches in the 4008
4.1.1 PCB LP631 (CPU1) DIP switch array 1
Note
Dip switch 6 is provided for service purposes/troubleshooting only and
must be set to the OFF position for treatment mode.
SH1 SH2 LP631

1 2 3 4 5 6 7 8
ON
OFF
Switch / position Function

SW 1 SW 2 Maximum UF rate
ON ON 1000 ml/h
OFF ON 2000 ml/h
ON OFF 3000 ml/h
OFF OFF 4000 ml/h
SW 3 SW 4 SW 5 Language 1 Language 2 Language 3 Language 4
ON ON ON English English English English
OFF ON ON German Finnish Japanese Hungarian*
ON OFF ON French Czech Bulgarian Romanian**
OFF OFF ON Portuguese Danish Greek
ON ON OFF Dutch Russian Arabic*
OFF ON OFF Italian Turkish Norwegian*
ON OFF OFF Swedish Polish Slovenian*
OFF OFF OFF Spanish Slovakian Ex-Yugoslavian*
SW 6 CRC/RAM test
ON Skip
OFF Perform
SW 7 Heater rod
ON 1300 W (at 100 to 120 V)
OFF 1600 W (at 220 to 240 V)
SW 8 Test and cleaning flow
ON 500 ml/min
OFF 800 ml/min
The basic position upon delivery is shown in italics.

For "not used", the switch must be set to OFF.
*
4008 H/S only
**
4008 H Prometheus only

SH1 SH2 LP631

1 2 3 4 5 6 7 8
ON
OFF

SW 1 CAL mode
ON Mode 0
OFF Mode 1
SW 2 SW 3 External alarm input
ON ON Not valid
OFF ON RO system
ON OFF Patient bell
OFF OFF External alarm
SW 4 Remote control
ON Device with remote control
OFF Device without remote control
SW 5 COMMCO PCB LP 763 or PCB LP 758 or PCB LP 729
ON Enabled
OFF Disabled
SW 6 COMMCO
ON Special record
OFF Standard record
SW 7 Rinse section test (not CDS)
ON Active
OFF Not active
SW 8 Central Delivery System
ON Installed
OFF Not installed


Warning
DIP switches 3 and 8 allow the operator to skip test steps which are
requested by the device.
If the switches are set to the "can be skipped" position, it is important to
know that the operator can then bypass the automatic test of the safety
systems.
The person demanding this switch position shall be solely responsible
for such a procedure.
LP632 SW1 SW2

1 2 3 4 5 6 7 8
ON
OFF

SW 1
ON
OFF Not assigned
SW 2 T1 test
ON Serial sequence
OFF Parallel sequence
SW 3 T1 test
ON Skip
OFF Mandatory
SW 4 Service test
ON "ON" (individual test steps can be selected, dialysis not possible)
OFF "OFF" (automatic T1 test)
SW 5 Cyclic PHT
ON Every 2 minutes and indication of the test result (service)
OFF Every 12.5 minutes, alarm output only with cyclic PHT alarm
SW 6 Cyclic PHT
ON "ON"
OFF "OFF"
SW 7 Level detector
ON With PCB LP 450 without AD28
OFF With PCB 450-2 and/or with AD28
SW 8 HDF test
ON Can be skipped
OFF Mandatory


LP632 SW1 SW2

1 2 3 4 5 6 7 8
ON
OFF

SW 1 DIASAFE / DIASAFE® plus
ON ON
OFF OFF
SW 2 ONLINE HDF
ON ON
OFF OFF
SW 3 ONLINEplus™
ON ON
OFF OFF
SW 4 Hydraulics
ON with HPU
OFF without HPU
SW 5 V39 test
ON OFF
OFF ON
SW 6 HDIS fast heater
ON Inactive
OFF Active
SW 7
ON
OFF Not assigned
SW 8
ON
OFF Not assigned


4.2 Calibration mode
4.2.1 Basic conditions
– The device must be switched off.

– The service switch must be in the ON (up)
position.
– Turn the device on.
Warning
If the Service switch is set to ON during the treatment or the cleaning
program, the heater relay will be turned off.

4.2.2 Messages on the displays on the UF monitor (4008 B) or on the screen (4008 H/S)
 4008 B
Ultrafiltration The values indicated on the display must be

UF Volume ml
Watchdog supply voltage divided by the factor 10.

0047 Reset
Volume Values in brackets: Tolerances
(4.5 V–5.5 V)
UF Rate ml/h
0119 12 V supply (11.5 V–12.5 V)
UF Goal ml
0236 24 V supply (23 V–25 V)
Time Left h:min
0204 Battery charging voltage (> 20 V)

UF
I/O Prog.
 4008 H/S
CALIBRATION
004.7 Volt
Watchdog supply voltage (4.5 V–5.5 V)
011.9 Volt
12 V supply (11.5 V–12.5 V)
023.6 Volt
24 V supply (23 V–25 V)
020.4 Volt
Battery charging voltage (> 20 V)
7 8 9 0 Esc
4 5 6
1 2 3 C Conf

4.3 Hydraulics
Note
Measuring equipment for measurement points in the hydraulic unit:
UMED, HMED, or pressure gage with measuring range from –1 to
+2.2 bar, minimum quality rating: 1.6
4.3.1 Reduced water inlet pressure
Measuring equipment: UMED, HMED, or pressure gage
Place of measurement: Hydraulics, measurement port A
Condition: Flow on
Check / adjustment:
– Checking the reduced water inlet pressure
Connect the measuring equipment to measurement port A.
Measure the water pressure with MV 41 closed.
Rated value of water inlet pressure: 0.90–1.40 bar
If it deviates from the rated value, the water inlet pressure must be adjusted.
– Adjusting the reduced water inlet pressure
Pull out the knurled nut on the pressure reducing valve (61).
Turn the knurled nut to set the water pressure to the desired value
(clockwise: +, counter-clockwise: –).
Push the knurled nut back in.

MV41
Measurement port A
MV41
Pressure reducing
valve
Measurement
port A
Pressure reducing valve (61)
4008 H 4008 B/S

4.3.2 Degassing pressure
Place of measurement: Hydraulics, measurement port D
Check / adjustment:
– Checking the degassing pressure
Connect the measuring equipment to the measurement port D.
Measure the degassing pressure.
Desired degassing pressure: –0.81 to –0.85 bar.
If it deviates from the desired value, the degassing pressure must be adjusted.
– Adjusting the degassing pressure
Enter the CALIBRATION menu, select and start the option CAL. DEGAS. PRESSURE
(see Part 7: Calibrating the degassing pressure on page 5-12).
Note
If the degassing pressure is changed, make sure to check the loading
pressure and adjust if necessary.
 Calibration of the degassing pressure at high altitudes
If 4008 devices are operated at high-altitude sites (observe sea level), the specified degassing pressure
cannot be reached. The calibration process has to be performed as follows:
The setting for the degassing pump has to be increased in increments from a low speed until no significant
increase of the negative pressure can be detected anymore.
This setting can also be stored.

91
117
104
Measurement
port D
Measurement
port D
118
4008 H 4008 B/S
Measurement port D
4008 B/S ONLINEplus™

4.3.3 Balancing chamber loading pressure
Place of measurement: Hydraulics, measurement port B
Check / adjustment:
– Checking the loading pressure of the balancing chamber
Connect the measuring equipment to the measurement port B.
Measure the loading pressure of the balancing chamber.
Rated value of the balancing chamber loading pressure: 1.2–1.3 bar
From 4008 B EC495, 4008 H EC295, 4008 S EC275 (change to the pressure spring in the loading
pressure valve):
The loading pressure of the balancing chamber has been increased to 1.45 bar ±0.05 bar.
If it deviates from the rated value, the loading pressure of the balancing chamber must be adjusted.
– Adjusting the loading pressure of the balancing chamber
Use the loading pressure valve (65) to adjust the loading pressure to the rated value.
Turning the adjusting screw clockwise will increase the loading pressure.
Note
During the balance chamber fill phase, the loading pressure will drop to
approximately 1.0 bar.
Note
If the loading pressure was changed, make sure to check the degassing
pump pressure and readjust, if necessary.

MV41 Loading pressure

valve 65
Loading pressure
valve 65 Measurement
port B
MV41
Measurement
port B
4008 H 4008 B/S

4.3.4 Flow pump pressure
Place of measurement: Hydraulics, measurement port C
Condition: A dialysate flow of 800 ml/min must have been preselected.
Check / adjustment:
– Checking the pressure of the flow pump
Connect the measuring equipment to the measurement port C.
Shut off the water supply. Water alarm, the balancing chamber stops.
Measure the pressure of the flow pump.
The desired pressure value of the flow pump depends on the loading pressure set:
Loading pressure: Flow pump pressure:
1.2 to 1.3 bar 1.9 to 2.1 bar
1.45 ±0.05 bar 2.2 ±0.05 bar
If it deviates from the rated value, the pressure of the flow pump must be adjusted.
– Adjusting the pressure of the flow pump
Use the relief valve (78) to adjust the rated value.
Measurement port C
Relief valve 78
4008 B/S

100
91
Relief valve 78
117
104
Measurement port C
118
4008 H
Measurement port C
Relief valve 78
4008 B/S ONLINEplus™

4.3.5 UF pump volume
Note
Incorrect measurement result when using a scale
The volume of fluid can be determined with a scale only if the specific
gravity of the fluid is known.
– Remove all concentrates.
– Measure weight with dialysis water (permeate).
Note
Incorrect measurement result when using an incompatible
graduated cylinder
– Use a graduated cylinder with a maximum tolerance of ±0.5%.
Measuring equipment: Scales or graduated cylinder, tolerance ±0.5%
Place of measurement: Hydraulics unit open
Condition: The CALIBRATION service menu is selected.

Perform the measurement with the device at operating temperature.
Check / adjustment:
– Checking the UF pump volume:
Remove the outlet tube / UF (2) of the UF pump (3) from the T-piece (1) and close the T-piece.
Place the outlet tube / UF (2) in the graduated cylinder.
Go to the CALIBRATION service menu and select and run the ADJ. UF-PUMP VOLUME 1 option
(see Part 6: Adjusting the UF pump volume on page 5-11).
Desired value: 60 strokes = 60 ml ±0.5 ml (59.6 g ±0.5 g dialysis water)
– Adjusting the UF pump:
Remove the protective cap.
Loosen the lock nut.
Change the delivery volume using the adjusting screw (turning the adjusting screw clockwise reduces,
turning it counter-clockwise increases the stroke volume).
Retighten the lock nut.
Verify the delivery volume.

4008 B/S

4008 H

4.3.6 CDS (Central Delivery System) pressure switch
Measuring equipment: UMED, HMED, or pressure gage (e.g., 0–1 bar, accuracy ±1%) and
syringe. For measurement setup see the following illustrations.
Place of measurement: Hydraulics unit open
Condition: CDS connections must be depressurized.

The pressure compensation ports on the pressure switches (PSW 123
and PSW 124) must be open to the atmosphere.
The tubes of the test equipment should be as short as possible.
The device is in Service mode.
Check / adjustment:
– Connect the test equipment as illustrated below.
– Select the DIAGNOSTICS service menu and then go to:
READ INPUTS
READ DIGITAL INPUTS
CPU1: RD DIGITAL INP
I: CPU1_PSW_V102 or I: CPU1_PSW_V104
– Activate the audible alarm by pressing the ALARMTONE MUTE key
(depressurized: audible alarm on).
– Under this menu option, the solenoid valves 102 and 104 are closed.
– Use the syringe to create a pressure of 0.7 bar.
– Use artery forceps to clamp the tube (1) so that a pressure of 0.7 bar continues to act on the pressure
switch.
– Check the switching point by means of the audible alarm.
Rated values:
Envec pressure switch: 0.68-0.72 bar
Fig.: CDS pressure switches (PSW 123 and PSW 124)

4008 B/S

4.3.7 Checking the bibag® pressure transducer (Envec)
General information on the The check can be performed by means of a multimeter or the
bibag® pressure DIAGNOSTICS service menu.
transducer
To read in the corresponding signal, select the menu item
I: CPU1_BIBAG_PSW menu item must be selected in the diagnostics
program.
Calibration of the pressure switch is not possible. The pressure switch
is set to a fixed position and can be checked in the DIAGNOSTICS
service menu.
The audible signal can be activated by pressing the ALARMTONE
MUTE key.
Options in the 1. The DIAGNOSTICS service menu can only be accessed in Service
DIAGNOSTICS service mode.
menu
– The device must be switched off.
– Set the Service switch to ON (up).
– Turn the device on.
Wait briefly until the Service mode screen is displayed.
– Use the  and  keys to select DIAGNOSTICS.
Confirm with Conf key.
2. In the DIAGNOSTICS service menu, continue as follows:
– Use the  and  keys to select DIAGNOSTICS.
– Use the  and  keys to select READ INPUTS.
– Use the  and  keys to select READ DIGITAL INPUTS.
– CPU1: Use the  and  keys to select RD DIGITAL INP.
– Use the  and  keys to select I:CPU1_BIBAG_PSW.
– The active levels 0000 or 1111 are still shown on the display.
Checking the switching Check the pressure switch PSW 134.

point
The maximum switching pressure is: 130 mbar +30 mbar
– Connect a pressure gage (e.g., HMED), a syringe and the
bibag® connection to the bibag® connector using a tube and
the T-connector.
– Slowly increase the pressure by means of the syringe,
continuously observing the pressure gage and the display,
until the active level on the display (I:CPU1_BIBAG_PSW) switches
from 0000 to 1111 and the audible alarm sounds.
Measured switching pressure: 130 mbar +30 mbar.
Note
In the menu item I:CPU1_BIBAG_PSW, the active level is identified by
1111.
The active level of the circuit output is LOW (< 1 V).

4.4 Level detector
Warning
For adjusting the level detector, the device must be in "Calibration"
mode. The ambient temperature should be between 15 °C and 35 °C.
Warning
The calibration using the level detector calibration set is only applicable
to devices running with Fresenius tubing systems.
Observe the "use by" date!
 Adjusting the level detector LD22, using the set for the level detector calibration
(see also adjustment instructions)
The device must be in Service mode and the bridge J1 / PCB LP450 in the calibration position.
Fill the hemispherical recesses of the adjusting block with grease and use a spatula to remove any excess
grease so that only the hemispherical recesses are completely filled with grease.
Introduce the greased reference block into the drip chamber holder (angled edges first). Ensure that the
ultrasonic sensors click correctly into place in the hemispherical recesses of the block. The reference
block must not touch the walls of the holder but hang freely between the sensors.
Turn the potentiometer 1 and then the potentiometer 2 on PCB LP450 clockwise until LED D5 and
LED D10 on PCB LP450 have turned dark.
Slowly (caution: allow for response time) turn the potentiometer 1 on PCB LP450 counterclockwise, until
the LED D5 on PCB LP450 lights up.
Slowly (caution: allow for response time) turn the potentiometer 2 on PCB LP450 counterclockwise, until
the LED D10 on PCB LP450 lights up.
Plug bridge J1 / PCB LP450 to the ‘operating’ position.
LED D5 and LED D10 must both be dark.
Take the reference block out of the drip chamber and completely remove the grease from the drip
chamber holder, using only lint-free cloth and permissible disinfectants.
Check:
Fill the hemispherical recesses of the test block with grease and use a spatula to remove any excess
grease so that only the hemispherical recesses are completely filled with grease.
Insert the greased reference block into the drip chamber holder. Ensure that the ultrasonic sensors click
correctly into place in the hemispherical recesses of the block. The reference block must not touch the
walls of the holder but hang freely between the sensors.
Both LED D5 and LED D10 must be illuminated. If one or two of the LEDs is not illuminated, repeat the
adjustment process.

Take the reference block out of the drip chamber and completely remove the grease from the drip
chamber holder, using only lint-free cloth and permissible disinfectants.
Fig.: PCB LP450
Potentiometer P1
LED D5
Potentiometer P2
LED D10
Jumper J1
Potentiometer P5

Fig.: Checking the venous occlusion clamp
Empty syringe (air)
UMED, HMED, or pressure gage
Clamp any unused tubes using artery forceps. Do not

connect them to the venous pressure inlet, for example
(pressure > 2 bar).
Connect the external pressure transducer to the UMED

"External Sensors 1–5" using the external sensor cable.
Only for UMED: not applicable for HMED or pressure gage!
Luer-lock adapter
Put the tubing into the venous occlusion clamp.

Fig.: Venous bubble catcher in the LD
Fluid level
Syringe filled with degassed water or NaCl solution

 Alternative: Adjusting the level detector without the set for the level detector calibration
Measuring equipment: Measurement setup according to diagram

UMED, HMED, or pressure gage, bubble catcher, syringe filled with
degassed water or NaCl solution
Place of measurement: Level detector
Check / adjustment:
– Adjusting the ultrasonic detector
Install the measurement set-up before checking / adjusting the level detector. Do not yet place the line
in the occlusion clamp.
Jumper J1 / PCB LP450 set to calibration.
Fill the bubble catcher. The fluid level must be set to approx. 10 mm above the top edge of the sensor
holder.
Turn potentiometer 1 and potentiometer 2 on PCB LP450 clockwise, until the LED D5 and LED D10
on PCB LP450 are dark.
Slowly (caution: allow for response time) turn the potentiometer 1 on PCB LP450 counterclockwise,
until the LED D5 on PCB LP450 lights up.
Slowly (caution: allow for response time) turn the potentiometer 2 on PCB LP450 counterclockwise,
until the LED D10 on PCB LP450 lights up.
After completion of the calibration procedure, set the jumper J1 / PCB LP450 back to the operation
position.
– Testing
Lowering the level in the bubble catcher: An alarm must be generated.
Raising the level in the bubble catcher again: It must be possible to clear the alarm; both LEDs are off.
– Checking the venous occlusion clamp (see fig.)
Place the tube into the venous line clamp.
Open the clamp and generate pressure of around 2 bar with syringe.
Close the clamp.
Ensure that the pressure does not drop by more than 0.1 bar within 3 minutes.
– Adjusting the optical detector
Use the 1-layer gray filter.
Diagnostics menu, read digital inputs CPU1, menu option I: CPU1_OD_IN.
Install the 1-layer gray filter; close the flap.
Slowly turn potentiometer P5 on PCB LP450 clockwise, until the UF display indicates 1111.
Slowly turn potentiometer P5 counterclockwise, until the display jumps to 0000. Continue to turn the
potentiometer counterclockwise for half a turn.
Avoid incident light from external sources.

Chapter 5: Calibration program
5 Calibration program
Key
CALIBRATION Conf
LM
DIAGNOSTICS
LM
MISCELLANEOUS
LM
SETUP MENU
LM
Adjustments made without display messages:
Settings without menu display Description
Adjusting the blood pump stop alarm (see Without menu display: Adjusting the
(blood pump or HDF pump) blood pump stop alarm (blood pump or HDF
pump) on page 5-5)
Calibrating the Single Needle blood pump (see Without menu display: Calibrating the
Single Needle blood pump (SN pressure)
(option) on page 5-10)
Adjusting the current rise pulse (see Adjusting the current rise pulse: on
page 5-13)
Adjusting the Hall sensor in the heparin pump (see Without menu display: Adjusting the Hall
sensor in the heparin pump on page 5-40)
In the Calibration, Diagnostics, Setup, and Miscellaneous programs, the function of the keys differs
between 4008 B and 4008 H/S systems.
Function 4008 B 4008 H/S
Scrolling through menu items  
Selecting a menu item Conf Conf
Changing values and functions in the menus  +/-
Storing the modified values Override ALARMTONE

MUTE
Exiting a menu without saving the data Select Esc
In the description of the steps, the keys to be used on 4008 H/S systems are shown in brackets.

 Main menu
CALIBRATION
Key
Conf
Key see part 1

CAL. ART. PRESSURE Conf
LM
Key
CAL. ART. P_MODULE see part 2
Conf
LM
Key
CAL. VENOUS PRESSURE see part 3
Conf
LM
Key
CAL. VEN. P_MODULE Conf see part 4
LM
Key
CALIB. (B)-PUMP-RATE Conf see part 5
LM
Key see part 6

ADJ. UF-PUMP VOLUME
Conf
LM
Key
CAL. DEGAS. PRESSURE Conf
see part 7
LM
Key
CAL. FLOW 300 ml/min Conf
see part 8
LM
Key
CAL. FLOW 500ml/min see part 9
Conf
LM
Key
CAL. FLOW 800ml/min Conf
see part 10
LM
Key
CALIB. TEMPERATURE Conf
see part 11
LM
Key see part 12

CAL. MIXING-SYSTEM
Conf
LM
Key
CALIB. CONDUCTIVITY Conf see part 13
LM
Key
CAL. DIAL. PRESSURE Conf
see part 14
LM
Key
CALIBRATE BLD Conf see part 15
LM
Key
CALIB. BIBAG VALUES Conf
see part 16
(option)
LM
Key
RESET FAILURE RECORD Conf see part 17
LM
Key
NOVRAM Conf see part 18
LM
Key
BACK TO MAIN MENU ? Conf
LM

Note
Before calibrating the hydraulics, remove any existing precipitate by
running an appropriate disinfection program.
 Part 1: Calibrating the arterial pressure
CAL. ART. PRESSURE
Key
Conf
Key Arterial pressure transducer

Arterial PRESSURE open to atmosphere art.zero.: ±0 mmHg
Conf
LM Override key (ALARM-

TONE MUTE)
Key
Art. PRESS. CHECK Conf
ACKNOWLEDGED
LM art.press: ±0 mmHg
Key After approx. 3 seconds
Back to menu ? Conf Activate various pressure values.
The values on the display, the
LM arterial pressure display and the art.gain.: +210 mmHg
reference meter must be
identical. Check whether the
scale limits can be reached Apply ≥ 210 mmHg to the
Tolerance: ±10 mmHg arterial pressure transducer
(reference meter!)
Select key (Esc)

Set the value of the
reference meter on the
display by pressing the
 (+/-) keys
Override key (ALARM-

TONE MUTE)
Note:
If calibration of this function is
not possible, the CAL. ART. DATA STORED
P_MODULE mode must first
be run.
After approx. 3 seconds
Note
Pressure gage accuracy: ±1% of the measured value.

 Part 2: Calibrating the pressure in the arterial blood pump
Set the hex switch in the module (PCB LP 624, pos. 1) to position F.
Should the error message E02 appear on the blood pump display, clear the message by pressing the
Start/Stop key.
CAL. ART. P_MODULE
Key
Conf
Select key
art.press: XXX mmHg (Esc)
Arterial pressure transducer

open to atmosphere
(arterial blood pump)
Set the value on the alpha-

display to 000 mmHg by
pressing the  keys on
the blood pump module
Apply by pressing the

Start/Stop key on the blood
pump module
Syringe connected to
external reference meter,
connect to arterial pressure
transducer
Apply exactly 250 mmHg to

the pressure transducer
Press the  keys on the

blood pump module to adjust
the slope until the alpha-
display matches the external
reference meter
Confirm by pressing the Start/Stop

key on the blood pump module
The values are saved. If this

message fails to appear, repeat
the calibration procedure
To complete, return the hex switch to position 0.

 Without menu display: Adjusting the blood pump stop alarm (blood pump or HDF pump)
Set the hex switch in the module (PCB LP 624, pos. 1) to position B.
Start/Stop key.
Use the  keys on the blood pump

module to change the default value
(15/30 seconds)
Apply by pressing the

Start/Stop key on the
module
The stored value is displayed after

2 seconds
To complete, return the hex

switch to position 0
Automatic reset on the module

 Part 3: Calibrating the venous pressure
CAL. VENOUS PRESSURE
Select key Key

(Esc) Conf
Key Select key

Venous PRESSURE ven.zero.: ±0 mmHg (Esc)
Conf
LM Venous pressure transducer on the

level detector is open to
Key atmosphere
Ven. PRESS. CHECK Conf
Select key
LM (Esc) ven.press: ±0 mmHg Override key
(ALARMTONE MUTE)
Key
Back to menu ? Conf Activate various pressure values. ACKNOWLEDGED
The values on the display, the venous
LM pressure display and the reference
meter must be identical. After approx. 3 seconds
Check whether the scale limits can be
reached.
Tolerance: ±10 mmHg
ven.gain. : +500 mmHg
Select key Connect the external

(Esc) reference meter
Apply ≤ 500 mmHg to the venous

pressure transducer.
Read the external reference meter
and set the value on the display by
Note: pressing the  (+/-) keys
If calibration of this function is not
possible, the CAL. VEN.
P_MODULE mode on the level Override key
detector must first be run. (ALARMTONE MUTE)
DATA STORED
Note
Pressure gage accuracy: ±1% of the measured value.

 Part 4: Calibrating the venous pressure measurement in the level detector
CAL. VEN. P_MODULE
Key
Conf
Select key
ven.press: XXX mmHg (Esc)
Venous pressure transducer

is open to atmosphere
(LD module)
Adjust the zero point

potentiometer (P3/PCB LP 450)
in the level detector until the
display indicates ±0 mmHg
ven.press: ±0 mmHg
Syringe connected to external

reference meter, connect to
venous pressure transducer
Apply ≥ 400 mmHg to the

pressure transducer
With the slope potentiometer

(P4/PCB LP 450) set the value
of the external reference meter
on the display
Select key
(Esc)
Note:
Check zero point and slope; repeat
the procedure if necessary.
Note:
If adjustments are made to the level
detector, the CAL. VENOUS
PRESSURE menu item must be
run.
Fig.: PCB LP450
Potentiometer P3
Potentiometer P4

 Part 5: Calibrating the blood pump rates
CALIB. (B)-PUMP-RATE
Key
Conf
Key see part 5.1

CALIB. ART. BP-RATE Conf
LM
Key
CALIB. SN. BP-RATE see part 5.2
Conf
LM
Key see part 5.3

CALIB. HDF-PUMP-RATE Conf This function is only possible if ONLINE HDF is activated with the DIP switch.
LM
Key
Back to menu ? Conf
LM
 Part 5.1: Calibrating the arterial blood pump
CALIB. ART. BP-RATE
Key
Conf
Key Select key

CALIB. ART. BP-RATE Conf (B)P Rate=550 ml/min (Esc)
LM
Set a rate of ≥ 550 ml/min* on
Key the arterial blood pump
art. BP-Rate CHECK Conf (B)P Rate=550 ml/min

Set various delivery rates on
TONE MUTE)
the arterial blood pump,
Key the values on the display
Back to menu ? Conf and the BP must be identical
DATA STORED
LM
Select key After approx. 3 seconds
(Esc)
Note: Set the tube diameter to 8 mm before starting the calibration procedure and press Start/Stop on the blood pump.
* The BP rate of 550 ml/min is a default value! It can be changed with  (+/-).

 Part 5.2: Calibrating the Single Needle blood pump rate (option)
CALIB. SN. BP-RATE
Key
Conf
Using a syringe, set the pressure at the P-SN
connector according to the set stroke volume Key Select key
CALIB. SN. BP-RATE Conf (B)P Rate=550 ml/min (Esc)
(see table).
LM
Set a rate of ≥ 550 ml/min* on
Key the SN blood pump
SN. BP-Rate CHECK Conf (B)P Rate=550 ml/min

Set various delivery rates on
TONE MUTE)
the SN blood pump,
Key the values on the display
Back to menu ? Conf and the BP must be identical DATA STORED
LM
Select key
(Esc) After approx. 3 seconds
Note: Set the tube diameter to 8 mm before starting the calibration procedure and press Start/Stop on the blood pump.
* The BP rate of 550 ml/min is a default value! It can be changed with  (+/-).
SN pump: lower switching point fixed to 75 mmHg
Stroke volume (ml) 10 15 20 25 30 35 40 45 50
(mmHg) ±7 mmHg
 Setting the Single Needle stroke volume
Press the  and Start/Stop keys at the same time.

Press the  and  keys to set the stroke volume and confirm with the Start/Stop key.
 Part 5.3: Calibrating the ONLINE HDF pump (option)
CALIB. HDF-PUMP-RATE
Key
Conf
Key Select key

CALIB. HDF-PUMP-RATE Conf (B)P Rate=400 ml/min (Esc)
LM Use the  (+/-) keys to enter

the value of the HDF pump
Key display.
HDF-Pump-Rate Check Conf (B)P Rate=200 ml/min (max)

Set various delivery rates on the
TONE MUTE)
HDF pump,
Key the values on the display and
Back to menu ? Conf the HDF pump must be identical
DATA STORED
LM
Select key
(Esc) After approx. 3 seconds
Note: This function is only possible if ONLINE HDF is activated with the DIP switch.

 Without menu display: Calibrating the Single Needle blood pump (SN pressure) (option)
Set the hex switch in the module (PCB LP 624, pos. 1) to position F.
Start/Stop key.
The Single Needle pressure

transducer is open to the atmosphere
(Single Needle blood pump)
Press the Start/Stop key on the Single Needle

blood pump
Syringe connected to external

reference meter, connect to Single
Needle pressure transducer
Apply exactly 250 mmHg to

the pressure transducer
Confirm by pressing the

Start/Stop key on the Single
Needle blood pump
The values are saved.
To complete, return the hex

switch to position 1. Then select
the item SN. BP-Rate
CHECK.
Check the Single Needle stroke volume
Preset stroke volume, e.g., 30 ml
Using a syringe and the external

reference meter, check the lower (fixed
to 75 mmHg) and the upper switching
point (the upper switching point is
listed in the table depending on the
selected stroke volume).
If the switching points are

outside the tolerance, repeat
the calibration procedure.
SN pump: lower switching point fixed to 75 mmHg
Stroke volume (ml) 10 15 20 25 30 35 40 45 50
(mmHg) ±7 mmHg
Note
It may be necessary to change the Single Needle stroke volume: Press
the  and Start/Stop keys at the same time.
Press the  and  keys to set the stroke volume and confirm with the
Start/Stop key.

 Part 6: Adjusting the UF pump volume
ADJ. UF-PUMP VOLUME
Key
Optional Conf
Key Select key

UF-Pump 1 (Vers. I) Conf Pulse amount = 60 (Esc)
Optional
Enter the number of strokes with
 (+/-)
Key
UF-Pump 2 Conf
LM TONE MUTE)
Key
Back to menu ? Conf ACKNOWLEDGED
LM After approx. 3 seconds
Select key
Press uf key (Esc)
Remove the tube from the UF

pump, close the T-piece.
Hang the tube into a graduated
cylinder
Switch on the UF pump by

pressing the UF I/O key
Key
UF I/O uf pulses left = 60
Note: The remaining UF strokes are
Check the volume. Adjust the UF pump if necessary and indicated on the display.
repeat the procedure (see Chapter 4.3.5 on page 4-24). The number of preselected
strokes is shown on the UF
Goal display.
Note
Note
graduated cylinder

 Part 7: Calibrating the degassing pressure
CAL. DEGAS. PRESSURE
Key
Conf
Select key
Adjust degas.-press. (Esc)
Connect a pressure gage for the

degassing pressure.
Use the  (+/-) keys to set a
degassing pressure of –0.81 bar
to –0.85 bar

TONE MUTE)
DATA STORED
The messages
– Fill program active
– Set flow on
may appear here.
(see Degassing pressure on page 4-18)
 Part 8: 300 ml/min flow
CAL. FLOW 300 ml/min
Key
Conf
Select key
Flow (300) = XXX (Esc)
Use the  (+/-) keys to change the

digits in the UF Rate window until the
value matches the specified value
(300)

TONE MUTE)
DATA STORED
Important:
If it is impossible to adjust the 300 – 500 – 800 flow volumes, or if problems caused by flow alarms occur
after the "calibrate flow" message has appeared, this can be caused by the adjusted current rise pulse.
Note:
(only for devices with advanced hydraulics)
The flow selected first is accompanied by the DIASAFE-filling act. message which is displayed for the
duration of 17 balancing chamber switchings.

Adjusting the current rise pulse:

– Select CAL. FLOW 300, display: Flow (300) = XXX
– The actual flow XXX must be approx. 300, correct with the  and  (+/-) keys if necessary.
– Connect an oscilloscope to MP8 and MP1, and the ground MP7 to PCB LP634.
– Use P1 to set the current rise pulse as shown in the diagram below. Make sure that the actual flow
(XXX on the display) remains at approx. 300, adjust with  and  (+/-) if necessary.
MP1 1 V/cm
GND
MP8 2 V/cm
GND Time Base 1 second
Alternative adjustment of the current rise (if an oscilloscope is not available):

– Select "calibrate flow 300 ml/min".
– The system may react in two different ways:
1. The system runs with regular balancing 2. The system is in the "Intrinsic clock pulse" mode.
chamber switching. Display: Flow (300) = 147
Display: Flow (300) = XXX – Turn the potentiometer P1 clockwise, until
– If necessary, correct the flow with the  the system switches from "intrinsic clock
and  (+/-) keys until the actual flow is pulse mode" to regular balancing chamber
approx. 300. switching (wait for approx. 10 seconds after
– Turn the potentiometer P1 counterclockwise each rotation!).
(wait for at least 10 seconds after each – Display: Flow (300) = XXX
rotation), until the system switches to – If necessary, correct the flow with the 
"intrinsic clock pulse mode". and  (+/-) keys until the actual flow is
– Display: Flow (300) = 147 approx. 300.
– Now turn the potentiometer P1 clockwise – Turn the potentiometer P1 counterclockwise
(wait for at least 10 seconds after each (wait for at least 10 seconds after each
half-rotation!), until the actual flow again rotation), until the system switches to
indicates approx. 300. "intrinsic clock pulse mode".
– Turn the potentiometer P1 clockwise for – Display: Flow (300) = 147
another 2 rotations. – Now turn the potentiometer P1 clockwise
(wait for at least 10 seconds after each
half-rotation!), until the actual flow again
indicates approx. 300.
– Turn the potentiometer P1 clockwise for
another 2 rotations.
After adjusting the current rise pulse, check and, if necessary, readjust the 300 / 500 / 800 flow settings.

 Part 9: Calibrating the 500 ml/min flow
CAL. FLOW 500ml/min
Key
Conf
Select key
Use the  (+/-) keys to change

the digits in the UF Rate window
until the value matches the specified
value (500)

TONE MUTE)
DATA STORED
 Part 10: 800 ml/min flow
CAL. FLOW 800ml/min
Key
Conf
Select key
Use the  (+/-) keys to change

the digits in the UF Rate window
until the value matches the specified
value (800)

TONE MUTE)
DATA STORED

 Part 11: Calibrating the dialysate temperature
CALIB. TEMPERATURE
Key
Conf
Key
Temp. ADJUSTMENT Conf
see part 11.1
LM
Key
Check TEMPERATURE see part 11.2
Conf
LM
Key
OCM TEMP.-Check Conf
see part 11.3
LM
Key
Back to menu ? Conf
LM
Note
Accuracy of the measuring instrument to be connected externally:
±0.2 °C.

 Part 11.1: Adjusting the dialysate temperature
Temp. ADJUSTMENT
Key
Conf adj. temp to 37 °C
Key
adj. temp to 37 °C Esc
Connect the external reference meter.  XXXX ADC-digits

Connect the bibag® or place the bicarbonate suction tube
into the bic canister.  XXXX DAC-digits
Place the concentrate suction tube into the conc canister.
 XXXX ADC-digits
Use the +/- keys to adjust the
digital value in the UF Rate ()  XXXX ADC-digits
window
Wait for the temperature value on

the external reference meter to
reach 37.0 °C.
Key
ALARMTONE MUTE 7 8 9 0 Esc
4 5 6
DATA STORED
1 2 3 C Conf
 NTC3; 8 bit
Key
OCM TEMP.-Adjust Esc  Controlled variable, 8 bit
Device in bypass
 NTC3; 12 bit (with OCM option only)
 NTC109; 8 bit,
Wait for the temperature to
stabilize (37 °C).
When NTC 109 is activated in the SETUP
Display in the UF Rate
() window
MENU
Key
ALARMTONE MUTE
DATA STORED
OCM TEMP.-Adjust
 XXXX ADC-digits
 XXXX °C
 XXXX ADC-digits
 XXXX DAC-digits
7 8 9 0 Esc
4 5 6
1 2 3 C Conf
 NTC3; 8 bit (with OCM option: 12 bit)

 NTC3 temperature
 NTC4; 12 bit (with OCM option only)
 Dynamic measuring range switching
Note
The hydraulics unit must be installed, the rear panel closed, and the
DIASAFE® plus covered.

 Part 11.2: Checking the dialysate temperature
Check TEMPERATURE
Key
Conf
act. temp = 37.0 °C
Use to select the



Temperature setting field
set temp = XX.X °C
Specify a temperature by
pressing the +/- keys
Key
ALARMTONE MUTE
ACKNOWLEDGED
act temp = XX.X °C
Check whether the

preselected temperature is
achieved.
Check: Reference meter,
display, 37.0 °C LED
display corresponds to
115/116 digits in UF
Volume window ()
Repeat the Tolerance: ±0.5 °C.
procedure with
different values
(e.g., 35 / 39 °C) Key
Esc
 NTC3; 8 bit
act. temp = 37.0 °C 
 NTC109; temperature
 NTC109; 8 bit
 XXXX ADC-digits

 XXXX °C
 XXXX ADC-digits
Alpha- Temperature
display setting
7 8 9 0 Esc
4 5 6
1 2 3 C Conf

 Part 11.3: Checking the dialysate temperature for the OCM option
OCM TEMP.-Check
Key
Conf
Open the shunt interlock cap to

switch the device to bypass
mode.
act. temp = 37.0 °C
Use to select the



Temperature setting field
set temp = XX.X °C
Specify a temperature by
Key
ALARMTONE MUTE
ACKNOWLEDGED
act temp = XX.X °C
Check whether the

preselected temperature is
achieved
Check: Display, LED display
37.0 °C
Tolerance of the temperatures
displayed in the UF Rate 
Repeat the and UF Time Left fields:
procedure with ±0.2 °C
different values
(e.g., 35 / 39 °C)
Key
Esc
 NTC3; 12 bit
OCM TEMP.-Check  NTC3; temperature
 NTC4; 12 bit
 NTC4; temperature
 XXXX ADC-digits
 XX.XX °C
 XXXX ADC-digits
 XX.XX °C
Alpha- Temperature
display setting
7 8 9 0 Esc
4 5 6
1 2 3 C Conf

 Part 12: Calibrating the mixing system
CAL. MIXING-SYSTEM
Key
Conf
Key
Run-In PUMPS see part 12.1
Conf
LM
Key
DET. BAL.CHAMBER Vol Conf see part 12.2
LM
Key
cal. CONC.-PUMP-VOL Conf see part 12.3
LM
Key
CONC. PUMP VOL det. Conf see part 12.4
LM
Key
calib. BIC.-PUMP-VOL Conf see part 12.5
LM
Key
BIC. PUMP VOL det. see part 12.6
Conf
LM
Key
check CONC/BIC VOL. see part 12.7
Conf
LM
Key
Back to menu ? Conf
LM

 Part 12.1: Running-in of the membrane pumps
The membrane pumps have to run-in so that the concentrate/bicarbonate pumps reach their operating
temperatures before the pump volume is verified.
The concentrate suction tubes are in a container filled with water.
Run-In PUMPS
Key
Conf
* Select key * These messages

START MAND. FILLING? (Esc) only appear in devices
with advanced
Override key hydraulics
(ALARMTONE MUTE)
* Select key
MAND. FILLING active (Esc)
Time left displayed in the field

UF Volume
After 9 seconds
Select key
( Press ALARMTONE MUTE ) Press OVERRIDE (Esc)
Override key
(ALARMTONE MUTE)
Select key
mem puls left = 1000 (Esc)
The membrane pumps are

running,
the display counts down

 Part 12.2: Determining the balancing chamber volume
DET. BAL.CHAMBER Vol
Determining the balancing

chamber volume.
In case of balancing chambers WITH

volume label:
Read the volume label on the
balancing chamber.
In case of balancing chambers

WITHOUT volume label: Remove
the drain tube from the device,
collect two consecutive pulses of
fluid, measure the volume and
divide it by two.
Key
Conf
Select key
BC-Volume = 30.00 ml (Esc)
Enter the measured balancing

chamber volume with the 
(+/-) keys (tolerance ±1 ml)
Override key
(ALARMTONE MUTE)
DATA STORED
Note
Note
graduated cylinder

 Part 12.3: Calibrating the concentrate pump stroke
cal. CONC.-PUMP-VOL
Key
Conf
Select key
CONP-Vol = 0.828 ml (Esc)
Enter the measured volume of one

pump stroke by pressing the
 (+/-) keys
Override key
(ALARMTONE MUTE)
DATA STORED

 Part 12.4: Determining the concentrate pump volume
CONC. PUMP VOL det.
Key
Conf
* Select key * These messages

START MAND. FILLING? (Esc) only appear in devices
with advanced
Override key hydraulics
(ALARMTONE MUTE)
* Select key
Time left displayed in

the field UF Volume
After 9 seconds
Select key
conc pulses = 100 (Esc)
Override key
(ALARMTONE MUTE)
ACKNOWLEDGED
( )
Select key
Press ALARMTONE MUTE Press OVERRIDE (Esc)
Override key
(ALARMTONE MUTE)
Select key
conc puls left = 100 (Esc)
The concentrate pump runs for

100 strokes,
the display counts down.
Then measure and record the
volume removed by the pump.
Notes:
The factory setting is 100 strokes. This setting can be changed by pressing
the  (+/-) keys (depending on the graduated cylinder used). However, on
returning to CAL. MIXING-SYSTEM, the display will show the factory
setting again.
Check the volume and, if necessary,

repeat the procedure!
Note
Note
graduated cylinder

 Part 12.5: Calibrating the bicarbonate pump stroke
calib. BIC.-PUMP-VOL
Key
Conf
Select key
BICP-Vol = 1.050 ml (Esc)
Enter the measured volume of

one pump stroke by pressing
the  (+/-) keys.
Override key
(ALARMTONE MUTE)
DATA STORED

 Part 12.6: Determining the bicarbonate pump volume
BIC. PUMP VOL det.
Key
Conf
Select key
START MAND. FILLING? (Esc)
Override key
(ALARMTONE MUTE)
Select key

the field UF Volume
After 9 seconds
Select key
bic pulses = 50 (Esc)
Override key
(ALARMTONE MUTE)
Select key
ACKNOWLEDGED (Esc)
( Press ALARMTONE MUTE ) Press OVERRIDE

Select key
(Esc)
Override key
(ALARMTONE MUTE)
Select key
bic pulse left = 50 (Esc)
The bicarbonate pump runs

for 50 strokes,
the display counts down.
Then measure and record the
volume removed by the pump.
Notes:
The factory setting is 50 strokes. This setting can be

changed by pressing the  (+/-) keys (depending
on the graduated cylinder used). However, on
returning to CAL. MIXING-SYSTEM, the
display will show the factory setting again.
Check the volume and, if necessary, repeat the

procedure!
Note
Note
graduated cylinder

 Part 12.7: Checking the concentrate and/or bicarbonate volume
check CONC/BIC VOL.
Key
Conf
Select key
START MAND. FILLING? (Esc)
Override key
(ALARMTONE MUTE)
Select key

the field UF Volume
After 9 seconds
Select key
conc pulses = 100 (Esc)
Override key
(ALARMTONE MUTE)
Select key
ACKNOWLEDGED (Esc)
( )
Select key
Press ALARMTONE MUTE Press OVERRIDE (Esc)
Override key
(ALARMTONE MUTE)
Select key
mem puls left = 50 (Esc)
The pump runs for 50 strokes,

the display counts down. Then
measure and record the
volume removed by the pump
and compare it to the
calculated value.
Check the mixing ratio (dilution)
Notes:
This test step verifies the concentrate or bicarbonate pump
volumes in accordance with the parameters entered for the mixing
system (dilution, BC volume, CONC, and BIC pump volume).
The pump whose suction tube has been withdrawn is actuated.
The factory setting is 50 strokes. This setting can be changed by

pressing the  (+/-) keys (depending on the graduated cylinder
used). However, on returning to CAL. MIXING-SYSTEM, the
display will show the factory setting again.
Note
Note
graduated cylinder

 Part 13: Calibrating the conductivity
The indicated values are examples
CALIB. CONDUCTIVITY
Key
Conf
Key
CONDUCTIVITY Set see part 13.1
Conf
LM
Key
TEMP/COND COMP Calib see part 13.2
Conf
(with OCM option only)
LM
Key see part 13.3

OCM PULSE calibr.
Conf (with OCM option only)
LM
Key
CONDUCTIVITY Check Conf see part 13.4
LM
Key
OCM COND.-Check Conf see part 13.5
LM
Key see part 13.6

TEMP/COND COMP Check Conf (with OCM option only)
LM
Key
Back to menu ? Conf
LM

 Part 13.1: Setting the conductivity
CONDUCTIVITY Set
Key
Conf
Select key CD. set: 15.70 mS/cm

CD. set: 12.80 mS/cm (Esc)
Use to select the


Use to select the Concentrate setting field


Concentrate setting field
If no key is
If no key is conc. set = –X% pressed for
conc. set = ±0% pressed for approx.
approx. 4 seconds
4 seconds
Use  (+/-) to reduce the Use  (+/-) to raise the concentrate
concentrate pump volume to get to a pump volume to get to a CD in the
CD in the lower display range. upper display range.
e.g.,:
conc. set = –X% conc. set = +10%
Override key Override key

(ALARMTONE MUTE) (ALARMTONE MUTE)
ACKNOWLEDGED ACKNOWLEDGED
After approx. 3 seconds After approx. 3 seconds
CD. set: 12.80 mS/cm CD. set: XX.X mS/cm
Wait for the CD to stabilize. Wait for the CD to stabilize.

Compare the CD with the external Compare the CD with the external
reference meter. In case of reference meter. In case of
deviation, adjust the display by deviation, adjust the display by
pressing the  (+/-) keys. pressing the  (+/-) keys.
Override key Override key

(ALARMTONE MUTE) (ALARMTONE MUTE)
ACKNOWLEDGED DATA STORED
After approx. 3 seconds After approx. 3 seconds
 CD cell 7; 12 bit / 8 bit switching

CD. set: 12.80 mS/cm (with OCM option only)


 XXXX ADC-digits  CD cell 110; 12 bit / 8 bit switching
[ADC-digits (OCM)]
 XXXX Steps
(concentrate pump)
 XXXX Steps
(bicarbonate pump)
 XXXX ADC-digits
[ADC-digits (OCM)]
Alpha- Concentrate Bicarbonate
display setting setting
7 8 9 0 Esc
4 5 6
1 2 3 C Conf

 Part 13.2: Setting the temperature/conductivity compensation (with OCM option only)
TEMP/COND COMP Calib
Key
Conf act temp = XX.XX °C
Device in bypass
act temp = XX.XX °C

Key
Esc
 XX.XX mS/cm
Verify that the conductivity of  XX.XX mS/cm
both measuring cells in fields
UF Rate () and UF Time
() is identical and that it is  XX.XX mS/cm
within the window 13.9 to
14.5 mS/cm.
 XX.XX mS/cm
If the conductivity is outside
these limits: use to


Alpha- Concentrate Bicarbonate Temperature

select the Concentrate setting
display setting setting setting
field
If no key is
conc. set = ±0% pressed for 7 8 9 0 Esc
approx.
4 seconds 4 5 6
Use +/- to reduce/increase the
concentrate pump volume until the
conductivity is within the window 13.9 to 1 2 3 C Conf
14.5 mS/cm.
conc. set = +X%
ALARMTONE MUTE key

ACKNOWLEDGED
 XX.XX mS/cm
 XX.XX mS/cm
 XX.XX mS/cm
Verify that the preset temperature of 35 °C
is achieved and that it has stabilized.  XX.XX mS/cm
Check:
Display, LED display tolerance: ±0.5 °C
Alpha- Temperature
display setting
ALARMTONE MUTE key
7 8 9 0 Esc
ACKNOWLEDGED
4 5 6
After approx. 3 seconds 1 2 3 C Conf
act temp = XX.XX °C  CD cell 7;

Verify that the preset temperature of 39 °C
value in mS/cm after 35 °C confirmation
is achieved and that it has stabilized.
Check:
 CD cell 7, current value in mS/cm
Display, LED display tolerance: ±0.5 °C  CD cell 110;
value in mS/cm after 35 °C confirmation
ALARMTONE MUTE key  CD cell 110, current value in mS/cm
DATA STORED

 Part 13.3: Calibrating the OCM pulse (with OCM option only)
OCM PULSE calibr.
Verify that the conductivity is

within the window 13.9 to
14.5 mS/cm and wait for the
conductivity to stabilize.
Key
Conf
Key
Start PULSE calib. ? Esc
ALARMTONE MUTE key
Key
OCM PULSE UP activ Esc
Positive OCM pulse duration
Key
OCM PULSE DOWN activ Esc
Negative OCM pulse duration
OCM PULSE finished!
LED
ALARMTONE MUTE is flashing.
Info sound.
pos. Dialy: -XXXX.X neg. Dialy: XXXX.X

Alternating
Tolerance per pulse: ±25
ALARMTONE MUTE key
DATA STORED
Note
If the value is outside ±25, check the device’s conductivity measuring
system.
 Time elapsed since start of pulse

OCM PULSE UP activ calibration
 Counter
 Concentrate adjustment
 XXXX Seconds  CD cell 7, compensated CD value
 XXXX Index
 XXXX
 XXXX mS/cm
7 8 9 0 Esc
4 5 6
1 2 3 C Conf

 Part 13.4: Checking conductivity
CONDUCTIVITY Check
Key
Conf
act.cond: XX.X mS/cm
Use to select the



If no key is
conc. set = ±0% pressed for
approx.
4 seconds
Use the +/- keys to reduce the concentrate
pump volume.
e.g.,:
conc. set = –6%
Key
ALARMTONE MUTE
ACKNOWLEDGED
act.cond: XX.X mS/cm

Check conductivity.
Check:
Reference meter, display, LED display
Repeat the procedure

with different values
Key
Esc
 CD cell 7; 12 bit / 8 bit switching

act.cond: XX.X mS/cm (with OCM option only)


 XXXX ADC-digits  CD cell 110; 12 bit / 8 bit switching
[ADC-digits (OCM)]
 XXXX Steps
(concentrate pump)
 XXXX Steps
(bicarbonate pump)
 XXXX ADC-digits
[ADC-digits (OCM)]
7 8 9 0 Esc
4 5 6
1 2 3 C Conf

 Part 13.5: Checking the OCM conductivity (with OCM option only)
OCM COND.-Check
Key
Conf
OCM COND.-Check
Use to select the



If no key is
conc. set = ±0% pressed for
approx.
4 seconds
Use the +/- keys to reduce the concentrate
pump volume.
e.g.,:
conc. set = –6%
Key
ALARMTONE MUTE
ACKNOWLEDGED
OCM COND.-Check
Check conductivity.
Check:
Reference meter, display, LED display
Repeat the procedure

with different values
Key
Esc
 CD cell 7; 12 bit
OCM COND.-Check  CD cell 7
 CD cell 110; 12 bit
 CD cell 110
 XXXX ADC-digits (OCM)
 XX.XX mS/cm
 XXXX ADC-digits (OCM)
 XX.XX mS/cm
7 8 9 0 Esc
4 5 6
1 2 3 C Conf

 Part 13.6: Temperature/conductivity compensation test (with OCM option only)
TEMP/COND COMP Check
Key
Conf
The individual conductivities

and their compensation factors
are displayed in the fields
(see 4008 H/S)
The conductivity cells can be

cross-checked by changing
the concentration or
temperature
Key
Esc
 CD cell 7, compensated
act temp = XX.XX °C  CD cell 7, compensation factor
 CD cell 110; compensated
 CD cell 110, compensation factor
 XX.XX mS/cm
 XXXX mS/(cm*°C)
 XX.XX mS/cm
 XXXX mS/(cm*°C)
7 8 9 0 Esc
4 5 6
1 2 3 C Conf

 Part 14: Calibrating the dialysate pressure (stainless steel pressure transducer)
CAL. DIAL. PRESSURE
Key
Conf
Key
DIALYSATE Pressure Conf
see part 14.1
LM
Key
TMP-Check Conf see part 14.2
LM
Key
PDIAL2 press-check Conf
see part 14.3
LM
Key
Back to menu ? Conf
LM
Note
Measuring instrument accuracy: ±1% of the measured value

 Part 14.1: DIALYSATE Pressure
DIALYSATE Pressure
Key
Conf
Select key
adj.zero.: +XXX mmHg (Esc)
Open the dialysate circuit.

Flow off / UF off.
The dialysate pressure approaches "0"
Open the dialysate circuit
Set "0" mmHg on the display by pressing

the  (+/-) keys
Override key
(ALARMTONE MUTE)
adj.zero.: ± 0 mmHg
ACKNOWLEDGED
Close the dialysate circuit
Set flow on
Set flow on
Switch on the UF pump by

pressing the UF I/O key
dia.gain.: - 500 mmHg
Switch off flow

Close the dialysate circuit
Leave the UF pump running until

approx. –500 mmHg Switch on the UF pump by
is indicated by the external reference meter. pressing the UF I/O key
Switch off flow

Use potentiometer P3 / PCB LP 633 to set the value
indicated by the external reference meter on the
alpha-display. Leave the UF pump running
until approx. 500 mmHg is
indicated by the external
reference meter.
Repeat the
procedure until 0 and Enter the value indicated by the external
–500 mmHg match Not reference meter by pressing the
the external OK  (+/-) keys
reference meter
Override key
(ALARMTONE MUTE)
Opening the system

OK
Open the dialysate circuit!

After the system has detected that the circuit is
open, the flow is switched on automatically
Wait for LED override
Override LED is flashing
Override key
(ALARMTONE MUTE)
DATA STORED

 Part 14.2: TMP-Check
TMP-Check
Key
Conf
tmp: XXX mmHg
Use the UF pump to build up various negative

pressures (flow off / UF off). Compare the
values indicated on the display, the LED
display, and the external measuring
Select key
(Esc)
Note:
Observe the venous
pressure!
Note:
Switch the flow on and off
again once in a while, to
maintain the operating
temperature of the pressure
transducer.
 Part 14.3: PDIAL2 press-check (only in devices with advanced hydraulics)
PDIAL2 press-check 4008 H/S:

Key
Conf
PDial2: –XXX mmHg PDial2: –XXX mmHg

Use the UF pump to build up various negative
pressures (flow off / UF off). Compare the
values indicated on the display, the LED
display, and the external measuring XXXX ADC-digits
Select key
(Esc)
Note:
Observe the venous
pressure!
PDial2 Flow
display setting
7 8 9 0 Esc
4 5 6
1 2 3 C Conf
In 4008 H/S systems the flow compensation

function can also be checked:
Use to select the Flow setting field.


Adjust the flow with +/-.

Confirm with ALARMTONE MUTE.

 Part 15: Blood leak voltage
CALIBRATE BLD
Key
Conf
Key Select key

Adjust BLOOD-LEAK Conf volt. bll. = 5.0 V (Esc)
LM Set 5.0 V on the display by

pressing  (+/-)
Key Select key
Adjust DIMNESS Conf volt.dimn. = 5.0 V (Esc)
Override key
(ALARMTONE MUTE)
LM Set 5.0 V on the display by
pressing  (+/-)
Key
Back to menu ? Conf DATA STORED
Override key
(ALARMTONE MUTE)
LM After approx. 3 seconds
DATA STORED
Tolerance of dimness voltage: 5 V ±0.3 V.
Note: If values deviate, check the glass cuvette for contamination.

Close the housing; temperature 37 °C; avoid incident light from external sources.

 Part 16: Calibrating BIBAG values (option)
CALIB. BIBAG VALUES
Key
Conf
Key Select key

BIBAG Temp.-Adjust Conf connect 10kΩ ±0.1% (Esc)
LM Connect the calibration resistor (10 kΩ) to

* connector X107 (with advanced hydraulics: X12)
Key Select key
BIBAG Temp.-Check Conf act temp = XX.X °C (Esc)
Override key
LM
(ALARMTONE MUTE)
Key Select key
BIBAG Cond.-Adjust Conf connect 104Ω ±0.1% (Esc)
DATA STORED
Connect the calibration resistor (104 kΩ) to
connector X108 (with advanced hydraulics: X13)
Override key
(ALARMTONE MUTE)
ACKNOWLEDGED
Select key
connect 56.2Ω ±0.1% (Esc)
Connect the calibration resistor (56.2 kΩ) to

connector X108 (with advanced hydraulics: X13)
Override key
(ALARMTONE MUTE)
DATA STORED
LM
** Select key
Key
BIBAG Cond.-Check Conf act.cond: XX.X mS/cm (Esc)
LM
Key * With test plug: 25 °C
Back to menu ? Conf
** With test plug: 45.7 mS/cm or 84.5 mS/cm
LM
see also BIBAG Technical Manual

 Part 17: Resetting the failure record
RESET FAILURE RECORD
Key
Conf
Audible alarm
Select key
Are you sure ? (Esc)
Override key
(ALARMTONE MUTE)
ACKNOWLEDGED
 Part 18: Initializing the NOVRAM, resetting the mandatory rinse, resetting the V84 malfunction
Audible alarm
Select key
Are you sure ? (Esc)
Override key
(ALARMTONE MUTE)
NOVRAM ACKNOWLEDGED
Key
Conf After approx. 3 seconds
Key
Init NOVRAM BACK TO MAIN MENU ?
Conf
LM
Audible alarm
Key Select key
Reset MAND. RINSE Conf Are you sure ? (Esc)
LM Override key
Audible alarm (ALARMTONE MUTE)
Select key
Key Are you sure ?
Reset CDS MAND. RINSE Conf
(Esc)
ACKNOWLEDGED
LM Override key
(ALARMTONE MUTE)
ACKNOWLEDGED
BACK TO MAIN MENU ?
BACK TO MAIN MENU ?
Audible alarm
Key Select key
Reset V84 Are you sure ? (Esc)
Conf
LM Override key
(ALARMTONE MUTE)
Key
Back to menu ? Conf
ACKNOWLEDGED Note:
LM The NOVRAM menu item can be entered only if DIP switch 1
(PCB LP 631, field 2) is operated in Calibration mode.
After approx. 3 seconds For this, the switch must be operated once and then returned to its
initial position.
BACK TO MAIN MENU ?

 Without menu display: Adjusting the Hall sensor in the heparin pump
Setting the hall sensors 1  Briefly press the "" key (syringe plunger holder moves to its upper
end position)
 Disconnect Hall sensor 2 (remove plug)
 Insert syringe which is selected on the hex switch (figure 2)
 Press and hold the "" key (until the syringe plunger holder is in the
lower end position).
 Repeat the following steps until the end of the syringe's scale (0 ml)
and the bottom of the plunger are on the same level:
– Unscrew the screw of Hall sensor 1 and slightly shift the sensor
(undefined), fix the screw.
– To verify, first press the ““ key to move the syringe plunger holder
up, then press the ““ key to move the plunger holder down.
– Check whether the syringe pump automatically stops (lowest point)
and whether the bottom of the plunger and the end of the syringe's
scale (0 ml) are on the same level.
 If the bottom of the plunger stops before having reached 0 ml, the
sensor must be unscrewed and adjusted downwards, if the syringe
pump moves beyond 0 ml, the sensor must be unscrewed and
adjusted upwards. If the error message "E55" occurs during the Hall
sensor adjustment, the message can be acknowledged by pressing
the "Start/Stop" key. If Hall sensor 1 was adjusted, the error
message "E55" must not occur anymore.
 Each time Hall sensor 1 was adjusted,. repeat the check whether the
syringe pump automatically stops at the described position.
 Briefly press the "" key (syringe plunger holder moves to its upper
end
 After adjusting Hall senor 1, Hall sensor 2 has to be re-connecte

Setting the hall sensors 2 Repeat the following steps until the end of the syringe's scale (0 ml) and
the bottom of the plunger are on the same level and the bottom of the
plunger is pressed against the bottom of the syringe:
 Press and hold the "" key until the syringe plunger holder is
approx. 2 cm before its lower end position
 Manually turn the threaded spindle in delivery direction (one scale
line on the syringe)
 Press and hold the "" key pressed (until the syringe plunger holder
has reached its lower end position)
 Unscrew the screw of Hall sensor 2 and slightly shift the sensor
(undefined), fix the screw.
 To verify, first press the ““ key to move the syringe plunger holder
up, then press the ““ key to move the plunger holder down.
 Check whether the syringe pump automatically stops (lowest point),
whether the bottom of the plunger and the end of the syringe's scale
(0 ml) are on the same level and whether the bottom of the plunger
is pressed against the bottom of the syringe.
 If the bottom of the plunger stops before having reached 0 ml, the
sensor must be unscrewed and adjusted downwards, if the syringe
pump moves beyond 0 ml, the sensor must be unscrewed and
adjusted upwards.
If the error message "E55" occurs during the Hall sensor adjustment,
the message can be acknowledged by pressing the "Start/Stop" key. If
Hall sensor 2 was adjusted, the error message "E55" must not occur
anymore.
Each time Hall sensor 2 was adjusted, repeat the check whether the
syringe pump automatically stops at the described position.
 Briefly press the "" key (syringe plunger holder moves to its upper
end position)
 After having adjusted both Hall sensors, apply screwlock to the
screws.
The hex switch position is not changed while the syringe type remains
the same.

Hall sensor 1
Hall sensor 2

Chapter 6: Diagnostics program
6 Diagnostics program
6.1 General information
The diagnostics program can be used to activate all of the device’s inputs and outputs.
Activation refers to CPU1 (PCB LP 631) and CPU2 (PCB LP 632), as well as to the output board
(PCB LP 634) and the input board (PCB LP 633).
This program allows technicians to make their own settings for testing error symptoms.
The diagnostics program is broken down into the following menus:
– READ INPUTS
– READ ANALOG INPUTS
– CPU1: RD ANALOG INP.
– CPU2: RD ANALOG INP.
– READ DIGITAL INPUTS
– CPU1: RD DIGITAL INP
– CPU2: RD DIGITAL INP
– WRITE OUTPUTS
– WRITE ANALOG OUTPUTS
– CPU1: WR ANALOG OUTP
– CPU2: WR ANALOG OUTP
– WRITE DIGIT. OUTPUTS
– CPU1: WR DIGIT. OUTP
– CPU2: WR DIGIT. OUTP
– INP/OUTP COMBINATION
– CPU1: COMBINATION
– CAN-COMPONENTS
– HPU
– ONLINE PLUS MODULE
In order to indicate the corresponding levels, all UF-seven-segment displays as well as the status indicator
(monitor), the external traffic light and the loudspeaker are used in the "READ DIGITAL INPUTS" menu.
The active signal state (which may correspond to both present and absent voltage) is indicated by 1111
on the UF displays, activated traffic light (status indicator), and audible signal.
The audible signal can be deactivated by pressing the alarm ALARMTONE MUTE key. If the audible
signal is deactivated, the ALARMTONE MUTE LED alarm flashes to alert the operator.
The audible signal allows the operator to evaluate the signal state without having to have a view of the
monitor. This is advantageous if measurements must be taken behind the device (e.g., hydraulics unit).

Note
In the diagnostics program, the signals are listed in the order of their
electric connection, i.e., in latch groups of 8 signals each, according to
the 8-bit data bus and according to the latch numbering on the circuit
diagram
(e.g., PCB 633: CS_LATCH0 – CS_LATCH6).
The signals are not grouped by relationship (e.g., all bibag® signals in a
row). The exceptions here are the signals for activating the solenoid
valves. If possible, these are listed in the menu by their number to
facilitate finding an individual valve because, usually, several valves
must be activated at the same time for troubleshooting purposes.
Since the signals are assigned to their respective connections (latch
groups), it is always possible to use the circuit diagram to locate the
respective signal in the menu, even if the signal name has changed.
Within one latch group, only one known signal is needed to find the
renamed signal by counting through the menu.
All voltage values specified can differ due to the tolerances in the
particular devices.
The item I:CPU1_KEY_TESTING is located under the menu item CPU1: RD DIGITAL INP.
This menu item can be used to test the keys.
The key pressed is shown on the alpha-display.
The UP, DOWN, ACKNOWLEDGED, SELECT and I/O keys have not been implemented, since their
function can be tested by selecting the corresponding menu.
CALIBRATION
LM
Key
DIAGNOSTICS Conf
LM
MISCELLANEOUS
LM
SETUP MENU
LM

6.2 Menu structure
DIAGNOSTICS Key READ INPUTS

Conf
WRITE OUTPUTS
INP/OUTP COMBINATION
Key
Conf
CAN-COMPONENTS
BACK TO MAIN MENU ?
READ INPUTS
Key
Conf
Key (see Chapter 6.3 on

READ ANALOG INPUTS CPU1: RD ANALOG INP.
Conf page 6-5)
(see Chapter 6.4 on

CPU2: RD ANALOG INP.
page 6-7)
Back to menu ? Key

Conf

READ DIGITAL INPUTS CPU1: RD DIGITAL INP
Conf page 6-8)
(see Chapter 6.6 on

page 6-13)
Back to menu ? Key

Conf
Key
Back to menu ?
Conf

WRITE OUTPUTS
Key
Conf

WRITE ANALOG OUTPUTS CPU1: WR ANALOG OUTP page 6-17)
Conf
(see Chapter 6.8 on

CPU2: WR ANALOG OUTP
page 6-18)
Back to menu ? Key

Conf

WRITE DIGIT. OUTPUTS CPU1: WR DIGIT. OUTP
Conf page 6-19)
(see Chapter 6.10

CPU2: WR DIGIT. OUTP on page 6-25)
Key
Back to menu ?
Conf
Key
Back to menu ?
Conf
Key (see Chapter 6.11

INP/OUTP COMBINATION CPU1: COMBINATION
Conf on page 6-28)
Key
Back to menu ? Conf
Key (see Chapter 6.13

CAN-COMPONENTS HPU
Conf on page 6-30)
(see Chapter 6.12

ONLINE PLUS MODULE on page 6-29)
Key
Back to menu ? Conf

6.3 Reading the analog inputs of CPU1
Explanation:
UF Volume display: ADC value
UF Time Left display: Analog voltage (in 0.1 V), converted to the value at the input of PCB LP 633

I: CPU1_VEN_BPR_SET
Key
Prescribed venous blood pump rate
Confirm
0–8 V, IC 27/3, ADC 0–171
(Tube diameter 8 mm)
I: CPU1_PWR_WD
Voltage for watchdog monitoring

5 V, IC 27/26, ADC 107 I: CPU1_HDF_PR_SET
(4.5–5.5 V)
Prescribed HDF blood pump rate
0–2.7 V, IC 27/3, ADC 0–58
(HDF switched on,
I: CPU1_P_CONC tube diameter: 8 mm)
Not used
0 V, IC 27/27, ADC 0)
I: CPU1_ART_BPR_SET
I: CPU1_P_VEN Prescribed blood pump rate,

arterial
Venous pressure 0–8 V, IC 27/4, ADC 0–171
0–12 V, IC 27/28, ADC 0–255 (Tube diameter 8 mm)
I: CPU1_BPR_VEN I: CPU1_REF1
Venous blood pump rate AD 0 reference voltage

0–10 V, IC 27/1, ADC 0–215 2.5 V, IC 27/5, ADC 128
(Tube diameter: 8 mm) (2.3–2.5 V)
I: CPU1_PR_HDF I: CPU1_U_ACCU
Battery voltage
HDF blood pump rate e.g., 22 V, IC 28/26, ADC, e.g., 184
0–3.3 V, IC 27/1, ADC 0–72
(HDF switched on,
tube diameter: 8 mm)
I: CPU1_P_BIC
I: CPU1_BPR_ART Not used

0 V, IC 28/27, ADC 0
Arterial blood pump rate
0–10 V, IC 27/2, ADC 0–215
(Tube diameter: 8 mm)
I: CPU1_24V_EM
24V_EMERGENCY
24 V, IC 28/28, ADC 117
(22.5–26 V)

I: CPU1_P_ART I: CPU1_TEMP_DIAL3
Arterial pressure NTC temperature
0–10.5 V, IC 28/1, ADC 0–225 (Slot X107 / PCB LP 747)
0–12 V, IC 29/1, ADC 0–255
I: CPU1_BLL_DIM
I: CPU1_COND_SIGNAL3
Blood leak dimness voltage
5.0 V, IC 28/2, ADC 108 CD cell (slot X108 / PCB LP 747)
0–10.8 V, IC 29/2, ADC 0–231
I: CPU1_BLL
I: CPU1_FREE2
Blood leak voltage
5.0 V, IC 28/3, ADC 108 Not used, input open
IC 29/3
I: CPU1_U_BATT_SW
CD display
0–10.8 V, IC 28/4, ADC 0–231
Voltage for audible alarm if battery relay off
10.6 V, IC 29/4, ADC 110
I: CPU1_REF2
AD1 reference voltage I:CPU1_REF3

2.5 V, IC 28/5, ADC 128
(2.3–2.5 V) AD2 reference voltage
2.5 V, IC 29/5, ADC 128
(2.3–2.5 V)
I: CPU1_FREE1
Not used Back to menu ?

0 V, IC 29/26, ADC 0
Key
Confirm
I: CPU1_TEMP_DIAL2
Temperature NTC 109

0–12 V, IC 29/27, ADC 0–255 CPU1: RD ANALOG INP.
Not used
0 V, IC 29/28, ADC 0

6.4 Reading the analog inputs of CPU2
Explanation:
UF Volume display: ADC value
UF Time Left display: Analog voltage (in 0.1 V), converted to the value at the input of PCB LP 632

I: CPU2_BLL_DIM
Key Blood leak dimness voltage

Confirm 5.0 V, IC 12/13, ADC 116
I: CPU2_BPR_ART
I: CPU2_BLL
Arterial blood pump
0–9.6 V, IC 12/20, ADC 0–223 Blood leak voltage
5.0 V, IC 12/13, ADC 116
I: CPU2_P_ART
I: CPU2_+10V
Arterial pressure
0–10.6 V, IC 12/19, ADC 0–245 Reference voltage D-A converter / CPU2
10 V, IC 12/13, ADC 234
I: CPU2_P_VEN
I: CPU2_NC6
Venous pressure
0–11 V, IC 12/18, ADC 0–255 Not used
0 V, IC 12/13, ADC 0
I: CPU2_P_DIAL
Back to menu ?
Dialysate pressure
0–10 V, IC 12/17, ADC 0–231
Key
Confirm
I: CPU2_COND_SIGNAL
CD display CPU2: RD ANALOG INP.
0–10.8 V, IC 12/16, ADC 0–251
I: CPU2_TEMP_DIAL1
Temperature display
0–10.8 V, IC 12/15, ADC 0–251
I: CPU2_P_DIAL2
Control voltage for higher resolution

Dialysate pressure
0–10.9 V, IC 12/14, ADC 0–252

6.5 Reading the digital inputs of CPU1
Explanation:
All UF displays on 0000, traffic lights red, yellow, green, off: Low level applied to latch on PCB LP 633
All UF displays on 1111, traffic lights red, yellow, green, on: High level applied to latch on PCB LP 633
If high level is applied, an audible alarm is active at the same time. This can be suppressed by pressing
the alarm ALARMTONE MUTE key. In this case, the alarm ALARMTONE MUTE LED is lit.

I: CPU1_ABG_BYP
Key Not used

Confirm IC 19/7
I: CPU1_COND_V84
I: CPU1_ABG_ON
V 84 CD detection
IC 19/2 Not used
Test by pulling off / short-circuiting the sensors IC 19/8
I: CPU1_ABG_ALARM
I: CPU1_LDA1
Not used
IC 19/9
Level detector alarm channel 1
IC 19/3
Test level detector alarm / alarm-free
I: CPU1_V43
Valve 43
IC 13/2
I: CPU1_OD_IN Test by opening / closing the valve
Level detector optical system

IC 19/4
Test optical system, dark / light I: CPU1_V26
Valve 26
IC 13/3
I: CPU1_FL_SWITCH1 Test by opening / closing the valve
Float switch
IC 19/5
Trigger water deficiency in calibration mode: 0 I: CPU1_V24b
Open V 41 until water leaks out of the overflow tube: 1
Valve 24b
IC 13/4
Test by opening / closing the
valve
I: CPU1_CI
Balance chamber switching pulse
IC 19/6

I: CPU1_V24 I: CPU1_REED_RINSE
Valve 24 Concentrate reed contact

IC 13/5 IC 14/4
Test by opening / closing the valve Actuate rinse chamber / concentrate reed contact
I: CPU1_UF_P1
I: CPU1_BIBAG_C
Acknowledgment from UF pump 1
IC 13/6 Microswitch 138 / connector
Test only possible in combination menu IC 14/5
Test by connecting / removing the cap
I: CPU1_LDA2
I: CPU1_PSW_V102
Concentrate pressure switch
IC 13/7
IC 14/6
Preparation:
Test by building up / relieving pressure at the
Level detector alarm-free, and set CLAMP_CTRL
pressure switch
(CPU1: WR DIGIT. OUTP) to 1.
Test: Trigger level detector alarm
I:CPU1_PSW_V104
I: CPU1_SUB_W_P
Bicarbonate pressure switch
Acknowledgment from UF pump 2 IC 14/7
IC 13/8 Test by building up / relieving pressure at the
pressure switch
I: CPU1_LC11
I: CPU1_PWR_OFF
IC 13/9
Power off
IC 14/8
I: CPU1_REED_BIC
Bicarbonate reed contact I: CPU1_HEP_ON

IC 14/2
Press rinse chamber / bicarbonate reed contact Heparin pump on
IC 14/9
Switch heparin pump on / off
I: CPU1_BIBAG
I: CPU1_LA32
Microswitch 137 / connector
IC 14/3 IC 15/2
Test by connecting / removing the BIBAG

I: CPU1_SW_ON_OFF I: CPU1_SN
Device On/Off key Single Needle changeover

IC 15/3 IC 16/2
Briefly press the key Single Needle blood pump switching pressure
reached: 0
I: CPU1_PWR_FAIL
I: CPU1_ADKS
Power failure detection
IC 15/4 Single Needle blood pump recognition
connected
IC 16/3
Connect / disconnect blood pump (only when device
I: CPU1_SHUNT_OUTP is switched off)
Shunt interlock microswitch

IC 15/5
Both tubes in shunt interlock I: CPU1_BPSB_ART
and shunt interlock closed: 0
Arterial blood pump stop confirmation
IC 16/4
Press the start / stop key on the arterial blood pump
I: CPU1_SHUNT_INP

IC 15/6
Only red tube in shunt interlock I: CPU1_BPUS_ART
Arterial blood pump rotation stop
IC 16/5
Arterial blood pump alarm field on: 0
I: CPU1_SHUNT (Delete with start / stop key on blood pump)

IC 15/7
Open / close shunt interlock
I: CPU1_BPSB_VEN
Venous blood pump stop confirmation

I: CPU1_SERV_EN IC 16/6
Press the start / stop key on the venous blood pump
Not used
IC 15/8
I: CPU1_LEV_SIGNAL I:CPU1_BPUS_VEN
Venous blood pump rotation stop

Level sensor (NTC 6 – Replacement)
IC 16/7
IC 15/9
Preparation:
Test by pulling off / short-circuiting
Set SNST (CPU1: WR DIGIT. OUTP) to 1
the sensor pins
and wait for alarm field.
Venous blood pump on.
Test: Clear the alarm field by pressing
start / stop key on the venous blood pump

I: CPU1_HEP_ALARM I: CPU1_ACKN_CONC
Heparin pump alarm Not used

IC 16/8 IC 20/7
Trigger heparin pump alarm
(e.g., by blocking the slide carriage)
I: CPU1_ACKN_BIC
Not used
I: CPU1_BIB_LEVEL IC 20/8
Level sensor 135

IC 16/9
Test by pulling off / short-circuiting the sensor pins
I: CPU1_BIBAG_PSW
BIBAG pressure switch

IC 20/9
Test by building up / relieving pressure
I: CPU1_EXT_ALARM on the pressure switch
External alarm
IC 20/2
Trigger an external alarm
I: CPU1_RA21
Not used
IC 21/2
I: CPU1_SERVICE_MODE
Dialysis / calibration switchover

IC 20/3
Toggle the Service switch I: CPU1_HDF_ON
HDF on
IC 21/3
Press the HDF On / Off key
I: CPU1_LEVEL_UP
Raise LD level
IC 20/4
Press the Raise level key I: CPU1_V102
Acknowledgment from valve 102
IC 21/4
Open / close valve
I: CPU1_LEVEL_DOWN
Lower LD level
IC 29/5
Preparation: I: CPU1_V104
Level detector alarm-free, set CLAMP_CTRL
(CPU1: WR DIGIT. OUTP) to 1 Acknowledgment from valve 104
Test: Press the Lower level key IC 21/5
Open / close valve
I: CPU1_ADS_SN I: CPU1_CSS_REED
Not used
IC 21/6
IC 20/6

I: CPU1_HEAT_CLK I: CPU1_LATCH7_FREE7
IC 21/7 Not used
IC 7/8
I: CPU1_BYP_REQ
I: CPU1_LATCH7_FREE8
IC 21/8
Not used
IC 7/9
I: CPU1_CLP_REQ
IC 21/9 I: CPU1_DIP1: 00011100
Dip switch CPU1 / array 1

PCB LP 631/IC 12/2 – 9
I: CPU1_LATCH7_FREE1 The position of the dip switch is shown on the
alpha-display
Not used (1: Dip switch "ON")
IC 7/2
I: CPU1_DIP2: 00000000
Dip switch CPU1 / array 2
Not used PCB LP 631/IC 13/2 – 9
IC 7/3 The position of the dip switch is shown on the
alpha-display
(1: Dip switch "ON")
Not used
IC 7/4 I: CPU1_KEY_TESTING
Touch panel test

IC 73/2 – 6
I: CPU1_LATCH7_FREE4 The key pressed is shown on the alpha-display, the
associated LED keys light up
Not used
IC 7/5
I: CPU1_RCU_KEY_TEST
Touch panel test for
Not used RCU 4008 remote control
IC 7/6 The key pressed is shown on the alpha-display, the
associated LED keys light up
Not used Back to menu ?

IC 7/7
Key
Confirm

6.6 Reading the digital inputs of CPU2
Explanation:
All UF displays on 0000, traffic lights red, yellow, green, off: Low level applied to latch on PCB LP 632
All UF displays on 1111, traffic lights red, yellow, green, on: High level applied to latch on PCB LP 632
If high level is applied, an audible alarm is active at the same time. This can be suppressed by pressing
the alarm ALARMTONE MUTE key. In this case, the alarm ALARMTONE MUTE LED is lit.

I: CPU2_V26
Key Acknowledgment from valve 26
Confirm IC 4/9, open / close valve
I: CPU2_NC3
I: CPU2_V43
Not used
IC 4/2 Acknowledgment from valve 43
IC 5/2, open / close valve
I: CPU2_UF_P1
I: CPU2_BL_ALARM
Blood pump rate switching SN / HDF
IC 4/3
IC 5/3
I: CPU2_ACKN_AIRSEP
I: CPU2_PWR_OFF
Acknowledgment from air separation pump
IC 4/4 Power off
IC 5/4
I: CPU2_UF_P2 I: CPU2_FL_SWITCH+5V
Float switch
IC 5/5
IC 4/5
Trigger water deficiency in calibration mode = 0
Open V 41 until water leaks out
of the overflow tube = 1
I: CPU2_CI
Balance chamber switching pulse
IC 4/6
I: CPU2_LDA1

I: CPU2_V24 IC 5/6, level detector alarm / alarm-free
Acknowledgment from valve 24

I: CPU2_V24b
Acknowledgment from valve 24b


I: CPU2_LDA2 I: CPU2_BPST_VEN
Level detector alarm channel 2 Acknowledgment from special control for

IC 5/7 venous blood pumps
Preparation: IC 6/5
Level detector alarm-free, and set CLAMP_CTRL Test by setting BPST_VEN
(CPU1: WR DIGIT. OUTP) to 1 (CPU1: WR DIGIT. OUTP) to 1/0
Test: Trigger level detector alarm
I: CPU2_BPUS_VEN
I: CPU2_BPSB_VEN
Venous blood pump rotation stop
Venous blood pump stop confirmation IC 6/6
IC 5/8 Preparation:
Press the start / stop key on the venous blood pump Set SNST (CPU1: WR DIGIT. OUTP) to 1 and wait
for venous blood pump alarm field on.
Test: Clear the alarm field by pressing
start / stop key on the venous blood pump
I: CPU2_BPSB_ART
Arterial blood pump stop confirmation

IC 5/9
Press the start / stop key on the arterial blood pump I: CPU2_ADKS
Single Needle blood pump recognition
connected
IC 6/7
I: CPU2_V42 Connect / disconnect blood pump (only when device
is switched off)
Not used
IC 6/2
I: CPU2_LEVEL_UP
I: CPU2_BPST_ART Raise LD level
IC 6/8, press Raise level
Acknowledgment from arterial blood pump special
control
IC 6/3
Test by setting BPST_ART
I: CPU2_LEVEL_DOWN
(CPU1: WR DIGIT. OUTP) to 1/0
Lower LD level
IC 6/9
Preparation:
I: CPU2_BPUS_ART Level detector alarm-free, set CLAMP_CTRL
(CPU1: WR DIGIT. OUTP) to 1
Arterial blood pump rotation stop Test: Press the Lower level key.
IC 6/4
Arterial blood pump alarm field on = 0
(Delete with start / stop key on blood pump)
I: CPU2_RINSE
Concentrate reed contact
IC 7/2
Actuate rinse chamber / concentrate reed contact

I: CPU2_V147 I: CPU2_SERVICE_MODE
IC 7/3 Dialysis / calibration switchover

IC 8/3, toggle the Service switch
I: CPU2_REED_BIC
I: CPU2_HOT_RINSE
Bicarbonate reed contact
IC 7/4 Hot rinse switchover
Press rinse chamber / bicarbonate reed contact IC 8/4
Test by setting HOT_RINSE
(CPU1: WR DIGIT. OUTP) to 0/1
I: CPU2_PSW_104
I: CPU2_OD_OUT
Bicarbonate pressure switch
IC 7/5 Level detector optical system
Test by building up / relieving pressure at the IC 8/5, optical detector dark / light
pressure switch
I: CPU2_SNST
I: CPU2_V145
Single Needle control
IC 7/6 IC 8/6
I: CPU2_SHUNT_OUTP I: CPU2_24V_SW
Shunt interlock microswitch 24 V switch

IC 7/7 IC 8/7
Both tubes in shunt interlock
I: CPU2_SN
I: CPU2_SHUNT_INP Single Needle changeover

IC 8/8, SN switching pressure reached: 0
IC 7/8
Only red tube in shunt interlock
I: CPU2_HEAT_RL_WATCH
Acknowledgment from heater relay

I: CPU2_SHUNT IC 8/9

IC 7/9, open / close shunt interlock
I: CPU2_DIP1: 01100110
Dip switch CPU2, array 1

I: CPU2_ABG_ON IC 9/2 – 9
Position of the dip switch is shown on the
Not used alpha-display
IC 8/2 (1: Dip switch "ON")

I: CPU2_DIP2: 11000001
Dip switch CPU2, array 2
IC 10/2 – 9
Position of the dip switch is shown on the
alpha-display
(1: Dip switch "ON")
Back to menu ?
Key
Confirm

6.7 Setting the analog outputs of CPU1
Explanation:
UF Rate display: DAC value (adjustable with: 4008 B:  UF rate, 4008 H/S: +/-)
UF Time Left display: Analog voltage on PCB LP 634 in 0.1 V

O: CPU1_DAC_X2
Key Not used
Confirm IC 53/4
0–5 V (X634R/C13, 0–5 V)
O: CPU1_TEMP_SET
Prescribed temperature O: CPU1_STEUER_EP
IC 53/9
Degassing pump speed setting
0–5 V (X634R/C20, 0.2–10 V)
IC 53/3
0–4.4 V (X634L / between A, B, C 27
and A, B, C 28, 0–21 V)
O: CPU1_DAC_DIM
Dimness calibration voltage O: CPU1_STEUER_FP
IC 53/8
0–5 V (C634R/A11, 0–5 V) Flow pump speed setting
IC 53/2
0–4.4 V (X634L / between A, B, C 29
and A, B, C 30, 0–21 V)
O: CPU1_TEMP_ADJ
Temperature control balance voltage
IC 53/7 Back to menu ?
0–5 V (X634R/C21, 0–5 V)
Key
Confirm
O: CPU1_DAC_BLL
Blood leak calibration voltage CPU1: WR ANALOG OUTP
IC 53/6
0–5 V
(X634R/A12, 0–5 V)
O: CPU1_BIBAG_TEMP_AJ
Calibration voltage for temperature NTC
(Slot X107 / PCB LP 747)
IC 53/5
0–5 V (X634R/A13, 0–5 V)

6.8 Setting the analog outputs of CPU2
Explanation:
UF Rate display: DAC value (adjustable with: 4008 B:  UF rate, 4008 H/S: +/-)
UF Time Left display: Analog voltage on PCB LP 632 in 0.1 V

O: CPU2_HIGH_RES_OP
Key OP control voltage
Confirm for higher resolution dialysate pressure
IC 11/20, 0–10 V
O: CPU2_TEMP_DET_ADJ
Temperature display detuning

IC 11/2, 0–10 V (X632/A 23, 0–10 V) Back to menu ?
Key
Confirm
O: CPU2_DIAL_DET_ADJ
Dialysate pressure display detuning
IC 11/1, 0–10 V (X632/C 20, 0–10 V)
O: CPU2_P_ADS_DET
Not used
IC 11/20, 0–10 V (X632/A 20, 0–10 V)
O: CPU2_PV_DET
Venous pressure detuning

IC 11/20, 0–10 V (X632/C 18, 1–9 V)
O: CPU2_PA_DET
Arterial pressure detuning

IC 11/19, 0–10 V (X632/A 17, 4–7 V)
O: CPU2_COND_DET
CD display detuning
IC 11/19, 0–10 V (X632/A 21, 0–10 V)

6.9 Setting the digital outputs of CPU1
Explanation:
UF Rate display:
0000 = not active
1111 = active (level PCB LP 634)
(adjustable with: 4008 B:  UF rate, 4008 H/S: +/-)
CPU1: WR DIGIT. OUTP

O: CPU1_V33
Key Valve 33
Confirm IC 12/17
O: CPU1_V24 O: CPU1_V34
Valve 24 Valve 34
IC 10/19 IC 12/16
O: CPU1_V24b
O: CPU1_V35
Valve 24b
Valve 35
IC 10/13
IC 12/15
O: CPU1_V26
O: CPU1_V36
Valve 26
Valve 36
IC 10/18
IC 12/14
O: CPU1_V130
O: CPU1_V37
Valve 130
Valve 37
IC 10/17
IC 12/13
O: CPU1_V30
O: CPU1_V38
Valve 30
Valve 38
IC 7/16
IC 12/12
Valve 31
IC 12/19 Valve 41
IC 7/13
(Valve automatically closes after a short time
to prevent water from overflowing)
O: CPU1_V32
Valve 32
IC 12/18

Valve 43 Valve 102
IC 7/15 IC 10/12
(The valve can only be activated
if a mandatory rinse is not required)
O: CPU1_V84
Valve 84 O: CPU1_V104
IC 7/18
Note: Rinsing is required Valve 104
following activation of valve V84 IC 7/14
(The valve can only be activated
if a mandatory rinse is not required)
O: CPU1_V86
Valve 86
O: CPU1_V126
IC 7/17
Not used
O: CPU1_V87
O: CPU1_V145
Valve 87
IC 10/15 Not used
Valve 91 Not used

IC 10/14
Comment: The valve will be closed on exiting
the menu item (back to "CPU1: WR DIGIT.
OUTP"). O: CPU1_V172
Not used
Valve 99 Not used
IC 7/19
OUTP"). O: CPU1_AIR_SEP_PUMP
Air separation pump
IC 4/18, 19
(1111: clockwise)
Comment: The ASP stops running when this
O: CPU1_V100 menu item is exited
Valve 100
IC 4/17
OUTP").

O: CPU1_STOP_EP O: CPU1_FILL_ONE_CHAM
Degassing pump stop Filling one half of a balancing chamber

IC 4/16 Data word to Gal 23:
0100 0010 (V 32, 37 open)
O: CPU1_STOP_FP
Flow pump stop O: CPU1_EMPTY_ONE_CHA

IC 4/15
Emptying one half of a balancing chamber
Data word to Gal 23:
1100 0010 (V 32, 37, 38 open)
O: CPU1_SET_UF1_ON
UF pump 1 activation
IC 4/14
(0/1 jump = 1 stroke) O: CPU1_CO_L:XXXXXXXX
Concentrate pump step number

The data word to IC 2 is shown on the
O: CPU1_SET_UF2_ON alpha-display and can be changed by pressing
the UF rate UP/DOWN keys.
UF pump 2 activation Condition: Concentrate plug reed contact open
IC 4/13
(0/1 jump = 1 stroke)
O: CPU1_BI_L:XXXXXXXX
O: CPU1_SET_EN_UF2
Bicarbonate pump step number
Not used
Condition: Bicarbonate plug reed contact open
IC 4/12
O: CPU1_SET_FLOW_ON O: CPU1_ALARM_SOUND
Flow on
Audible alarm
IC 5/18, 19 to 1: active
0000 0010 (active, V 32 open)
0000 0011 (inactive, V 31, 32 open)
O: CPU1_WARN_SOUND
O: CPU1_SET_FILL_PRG Audible warning

IC 5/18 to 1, 19 to 0: active
Fill program
0000 1010 (V 32, 34 open) O: CPU1_INFO_SOUND
Info sound
O: CPU1_EMPTIING_PRG IC 5/18 to 0, 19 to 1: active
Emptying program
Data word to Gal 23: O: CPU1_CLK_OVERLAP
0001 0010 (V 32, 35 open)
Balancing chamber dead time switchover
IC 5/17 to 0: 1 kHz, to 1: 2 Hz

O: CPU1_EN_IN_PULSE O: CPU1_CPU_OFF
Intrinsic clock pulse switchover Automatic turnoff

IC 5/16 to 0: Intrinsic clock pulse; to 1: IC 13/18
Current rise switchover Device turns off in position 1
O: CPU1_BC_PULSE O: CPU1_EN_PF_AT
Balancing chamber switchover Power failure alarm enable

IC 5/15 IC 13/17
Preparation: Set WD_SET
Test: The power failure alarm can be
O: CPU1_EN_STEP_PULS activated / deactivated with EN_PF_AT set to
0/1
Gal switchover
IC 5/14
O: CPU1_PIC_RA3
O: CPU1_BC_FUNCTION
Not used
Balancing chamber Gal switchover IC 13/16
IC 5/13
O: CPU1_PROG_LOG1
O: CPU1_STEPPER_PULS
Program logic 1, HDF pump
Intrinsic clock pulse IC 13/14
IC 5/12 (0: speed 200, 1: speed 400)
O: CPU1_FL_SWITCH_EN O: CPU1_PROG_LOG2
V41 enable Program logic 2, HDF pump

IC 7/12 IC 13/13
Test: (0: speed 200, 1: speed 150)
Set level to 1 with float switch
down: V 41 open
Set level to 0 with float switch
down: V 41 closed O: CPU1_VENT_VALVE
Level detector vent valve

IC 13/12
O: CPU1_SNST
Single Needle control

IC 13/19
Preparation:
Level detector alarm-free, and set
CLAMP_CTRL
Test:
SNST to 1: Venous blood pump starts running
once SN switchover pressure is reached

O: CPU1_CLR_ALARM O: CPU1_BPSST_ART
Alarm clearing Arterial blood pump system stop

IC 11/18 IC 6/18
Test: Trigger heparin pump alarm: Alarm is
cleared by setting CLR_ALARM from 0 to 1.
O: CPU1_CLAMP_CTRL
Level detector clamp control

IC 6/17
O: CPU1_HOT_RINSE Preparation: Level detector alarm-free
Hot rinse switchover

IC 11/17
O: CPU1_BPST_VEN
Venous blood pump special control

O: CPU1_TEST_BATT IC 6/16
Battery test
IC 11/16
O: CPU1_BPSST_VEN
O: CPU1_CPU_AKKU Venous blood pump system stop

IC 6/15
Battery relay Preparation:
IC 11/15 Set SNST (CPU1: WR DIGIT. OUTP) to 1
Test: Pressurize Single-Needle blood pump;
use BPSST_VEN
to turn blood pump on / off
O: CPU1_HEAT_OFF
Heater blockage
IC 11/14
O: CPU1_BL_ALARM
O: CPU1_STAFF_CALL Blood pump rate switching

Single Needle / HDF
Nurse call IC 6/14
IC 11/13
O: CPU1_TL_YELLOW
O: CPU1_TL_RED
External traffic light yellow
External traffic light red IC 6/13
IC 11/12 The associated LED traffic light display for the
(The associated LED traffic light display for the display board is also activated
display board is also activated)
O: CPU1_TL_GREEN
O: CPU1_BPST_ART
External traffic light green
Arterial blood pump special control IC 6/12
IC 6/19 The associated LED traffic light display for the
display board is also activated

O: PUMP FASTER O: CPU1_ACKN_BL_ALARM

4008 H/S:
O: CPU1_BP_FASTER Not used
Blood pump rate adjustment+

(RCU 4008) O: CPU1_DISPLAY_TEST
PCB LP 649/X4.4; PCB LP 922/X5.4;
PCB LP 924/X6.4 All LED displays are run through
UF monitor display counts from 1 to 0
O: PUMP SLOWER
4008 H/S:
O: CPU1_BP_SLOWER
Back to menu ?
Blood pump rate adjustment –
(RCU 4008)
PCB LP 649/X4.5; PCB LP 922/X5.5; Key
PCB LP 924/X6.5 Confirm

O: CPU1_OVERLAP_VALUE
Loads the dead time counter

IC 3/12 – 19
(DAC 0–255 adjustable)
O: CPU1_V_ADS
Not used
O: CPU1_NC_I
Not used
O: CPU1_NC_II
Not used
O: CPU1_NC_III
Not used
O: CPU1_ACKN_FLOW
Not used

6.10 Setting the digital outputs of CPU2
Explanation:
UF Rate display:
0000 = not active
1111 = active (level PCB LP 632)
(adjustable with: 4008 B:  UF rate, 4008 H/S: +/-)

O: CPU2_UF_P_CTRL
Key UF pump 1 activation

Confirm IC 24/14, 0/1 jump = 1 stroke
Preparation: Set CPU2_UF_P_EN to 1.
O: CPU2_WD_RES
Watchdog reset
IC 24/18
Preparation: O: CPU2_UF_P_EN
Set WD_SET (CPU2: WR DIGIT. OUTP)
to 0, then back to 1 Enable UF pumps
Test: IC 24/13
Briefly set WD_RES to 0; when reset to 1,
WD relay is tripped
O: CPU2_CPU2_ALARM
Audible alarm triggered by CPU2

O: CPU2_WD_SET IC 24/12
Watchdog set
IC 24/17
Watchdog relay drops, 24 V is switched off, O: CPU2_UF_P2_CTRL
audible signal is sounded.
To reset the device, switch it off and UF pump 2 activation
back on again. IC 24/11, 0/1 jump = 1 stroke
Otherwise calibration is not possible. Preparation: Set CPU2_UF_P_EN to 1
O: CPU2_V24_EN
O: CPU2_4066_ENABLE_1
Enable V 24
IC 24/16 Analog switch for P_ADS_DET
Preparation: Switch on V 24 IC 20/13 (X632/A20)
(CPU1: WR DIGIT. OUTP)
Test: Switch valve on / off with V 24_EN
Analog switch for reference voltage +10 V

IC 27/5
O: CPU2_V24B_EN
Enable V 24b
IC 24/15
Preparation: Switch on V 24B
(CPU1: WR DIGIT. OUTP)
Test: Switch valve on / off with V 24B_EN Analog switch for PV_DET
IC 20/6 (X632/C18)

O: CPU2_4066_ENABLE_4 O: CPU2_CLAMP_CTRL
Analog switch for PA_DET Level detector clamp control

IC 20/12 (X632/A17) X632/C10
Preparation: Level detector alarm-free
O: CPU2_NC5
Analog switch, not used
IC 27/13 Not used
X632/B25
O: CPU2_4066_ENABLE_6 O: CPU2_NC7
Analog switch for COND_DET Not used
IC 20/5 (X632/A21) X632/B10
O: CPU2_4066_ENABLE_7 O: CPU2_BLL_DET
Analog switch for BLL_DIM
Blood leak detector detuning
IC 27/6
X632/A25
O: CPU2_4066_ENABLE_8 O: CPU2_SN_EN
Analog switch for BLL
Enable Single Needle
IC 27/12
X632/C19
O: CPU2_SN_ART O: CPU2_NC10
Arterial Single Needle control Not used
X632/A15 X632/B4
O: CPU2_LDSA O: CPU2_V26
Audible level detector alarm weakened Valve 26
X632/C16 X632/A6
Preparation:
Level detector alarm-free, and set
CLAMP_CTRL
Test: Set LDSA to 1 to close the clamp on the O: CPU2_V42
level detector
Not used
X632/C4
O: CPU2_ODSA
Optical level detector system weakened O: CPU2_V43

X632/C15
Valve 43
X632/C5

O: CPU2_VENT_DSAFE O: CPU2_LED6
Diasafe vent valve PCB LP 632 LED 6

X632/B5 IC 21/14
O: CPU2_LED7
O: CPU2_EM_HEAT_OFF
PCB LP 632 LED 7
Heater relay IC 21/13
X632/A9
After having been activated, the relay switches
off again for safety reasons
O: CPU2_LED8
PCB LP 632 LED 8

IC 21/12
O: CPU2_NC8
Not used
X632/B9
Back to menu ?
O: CPU2_NC9
Key
X632/C6 Confirm
IC 29/13
O: CPU2_LED1
PCB LP 632 LED 1

IC 21/19
O: CPU2_LED2
PCB LP 632 LED 2

IC 21/18
O: CPU2_LED3
PCB LP 632 LED 3

IC 21/17
O: CPU2_LED4
PCB LP 632 LED 4

IC 21/16
O: CPU2_LED5
PCB LP 632 LED 5
IC 21/15

6.11 Setting / reading the digital outputs of CPU1
Explanation:
UF Volume display: Acknowledgment / input (the 3 traffic light LEDs are also lit up with 1111)
UF Rate display: Activation / output (adjustable with: 4008 B:  UF rate, 4008 H/S: +/-)
CPU1: COMBINATION
CPU1_COMBI: V104
Key Valve 104
Confirm Activation PCB LP 634 / IC 7/14
Acknowledgment PCB LP 633 / IC 21/5
(The valve can only be activated if a
CPU1_COMBI: V24 mandatory rinse is not required)
Valve 24
Activation PCB LP 634 / IC 10/19
CPU1_COMBI: UF1_PUMP
UF pump 1
CPU1_COMBI: V24b Acknowledgment PCB LP 633 / IC 13/6
(When setting from 0 to 1 = 1 stroke,
Valve 24b acknowledgment is a brief jump to 1)
CPU1_COMBI: AIR_SEP
CPU1_COMBI: V26
ASP activation / deactivation
Valve 26
Back to menu ?
Key
CPU1_COMBI: V43 Confirm
Valve 43
CPU1: COMBINATION
CPU1_COMBI: V102
Valve 102
(The valve can only be activated if a
mandatory rinse is not required)

6.12 ONLINEplus™ Module
ONLINE-PLUS-MODUL
READ ANALOG INPUTS Key
Key Conf
Conf
READ INPUTS Key Key

Conf READ DIGITAL INPUTS Conf
Key
WRITE OUTPUTS Key
Conf Back to menu ?
Conf
Key
Back to menu ?
Conf
WRITE ANALOG OUTPUTS Key not yet implemented

Conf
Key
WRITE DIGIT. OUTPUTS Conf
O: ONL+_ONL1 (V193)
PCB LP 785 X1/6a
Valve Online 1 V193
Key
Back to menu ?
Conf
O: ONL+_ONL2 (V192)
PCB LP 785 X1/7a

Valve Online 2 V192
O: ONL+_ONL3 (V191)
PCB LP 785 X1/8a

Valve Online 3 V191
Key
Back to menu ? Conf

6.13 HPU
HPU
READ ANALOG INPUTS Key
Key Conf
Conf
READ INPUTS Key Key

Conf READ DIGITAL INPUTS Conf
Key
WRITE OUTPUTS Key
Conf Back to menu ?
Conf
Key
Back to menu ?
Conf
WRITE ANALOG OUTPUTS Key not yet implemented

Conf
Key
WRITE DIGIT. OUTPUTS Conf
O: WTR_AIR_P
Compressor
185
Key
Back to menu ?
Conf
O: WTR_V_TEST
Test valve
V183
O: WTR_V39
Negative pressure valve

V39
O: WTR_RETENT_V
Retentate valve
V189
O: WTR_V_EVAC_INDI
not yet implemented
O: WTR_V_EVAC_SOD
Evacuation valve
V188
Key
Back to menu ? Conf

Chapter 7: Setup menu
7 Setup menu
7.1 Overview of Setup menu settings

Conf
Menu item Submenu Default value Value range Resolution
SET ALARM/WARN TIME Set ART-AL DELAYTIME 5 seconds 0–5 seconds 1 second
Set VEN-AL DELAYTIME 5 seconds 0–5 seconds 1 second
Set FLOW-OFF W-TIME 30 minutes 30–60 minutes 15 minutes
Set UF-WARNING-TIME 10 minutes 10 / 30 minutes 20 minutes
Set MUTE-TIME 1 minute 1–2 minutes 1 minute
SETUP CLEANING PGM
CLEANING Times Rinsing TIME 15 minutes 5–30 minutes 1 minute
Hotrinse TIME 15 minutes 15–30 minutes 1 minute
Disinfection TIME 10 minutes 10–20 minutes 1 minute
Rinsing Free TIME CPU1: DIP switch array 1, SW 8 set to OFF
(Test flow 800 ml/min)
3 minutes 3–10 minutes 1 minute
For CDS:
CPU1: DIP switch array 1, SW 8 set to ON
For CDS:
Hot-Disinf TIME 10 minutes 10–20 minutes 1 minute
Mandatory Rinse TIME CPU1: DIP switch array 1, SW 8 set to OFF
For ONLINE HDF:
For ONLINEplus™:
For ONLINE HDF:
For ONLINEplus™:
CITRO-Mandat-Ri-Time CPU1: DIP switch array 1, SW 8 set to OFF
For ONLINE HDF:
For ONLINEplus™:
For ONLINE HDF:
For ONLINEplus™:
INTEGRATED-HR Time 15 minutes 15–40 minutes 1 minute


Pgm COMBINATION RINSE Pgm PGM 1: –R– PGM 1: –R–
Only for 4008 B PGM 2: –R– endless
HOTRINSE Pgm PGM 1: –F–HR–C– PGM 1: –F–HR–C–
PGM 2: –F–HR–
PGM 3: –IHR–
PGM 4: –IHR–C–
DISINFECTION Pgm PGM 2: –F–HDIS–M– PGM 1: –F–D–M–
PGM 2: –F–HDIS–M–
PGM 3: –F–D–M–HR–
DEFAULT Cleaning Pgm PGM 1: -R- PGM 1: -R-
Only for 4008 H/S PGM 2: -R- endless
PGM 1: -F-HR-C-
PGM 2: -F-HR-
PGM 3: -IHR-
PGM 4: -IHR-C-
PGM 1: -F-D-M-
PGM 2: -F-HDIS-M-
PGM 3: -F-D-M-HR-
PGM 4: -F-HDIS-M-HR-
SETUP DILUTION Canister Canister 1+34 Canister 1+34
1+35.83 ( NaCl 20 )
1+35.83 ( NaCl 26 )
1+35.83 ( Belgium )
Canister 1+44 C
Canister 1+44 ACF
VARIABLE SETTING
CDS CDS 1+34 CDS 1+34
CDS 1+44 C
CDS 1+44 ACF
VARIABLE SETTING – 0.800–2.500 0.001
– 30.000–45.000 0.001
– 25–45 1
– 25–80 1
HDF-DILUTION HDF–PRE–dilution HDF–PRE–dilution
Only applies to ONLINE HDF HDF–POST–dilution
(option)
SET CONDUCT. LIMIT Cd Limit: 12.8 mS/cm 12.8 mS/cm 12.8–14.0 mS/cm 0.1 mS/cm
INFO SOUND ( C-PGM ) Info Sound: ON Info Sound: ON
Info Sound: OFF
SET DIAL PARAMETERS
SET Flow Parameter Flow[ml/min]:500 500 ml/min 300 / 500 / 800 ml/min
Or value set in Dial
SET Temp. Parameter Temp.[°C]: 37.0 37 °C 35–39 °C 0.5 °C
SET Na/Bic Parameter Base Na+ 135 mmol 135 mmol 125–150 mmol 1 mmol
Prescr. Na+ 135 mmol 135 mmol 125–150 mmol 1 mmol
(±13 mmol around the
base value)
Bicarbonate: ±0 mmol 0 mmol –8 to +8 mmol 1 mmol
Limit Na/Base 13 mmol 13 mmol 0–13 mmol 1 mmol
Only for 4008 H/S But prescribed Na+,
base Na+
DIALYSIS TIME Effect. dialysis time Effect. dialysis time
Only for 4008 B UF time
CALC.CUMUL.BLOOD-VOL during seq DIAL: YES during seq DIAL: YES
during seq DIAL: NO
HAEMOGLOBIN UNIT g/dl g/dl
Only for BVM (optional) mmol/l


OCM SETTINGS OCM MEASUREMENT OCM Measurement: OFF OCM Measurement: OFF
Only for OCM (optional) and OCM Measurement: ON
4008 H/S OCM MEASURE DEL.TIME 4008 H with HPU:
15 seconds 1–70 seconds 1 second
4008 H with ONLINEplus™:
4008 S with HPU:
4008 S with ONLINEplus™:
OCM KT/V WARNLEVEL 85% 0–99% 1%
AUTOM. SN-START autom. SN: OFF autom. SN: OFF
autom. SN: ON
ACTIV. MONIT_NTC109 MONIT_NTC109: YES MONIT_NTC109: YES
MONIT_NTC109: NO
ACTIV. STD UF-DATA STD UF DATA: NO STD UF DATA: NO
STD UF DATA: YES
SET STD. PRIME-TIME Prime-Time = 2 min 2 minutes 1–5 minutes 1 minute
SOUND I/O-SWITCH I/O-Warnsound: ON I/O-Warnsound: ON
I/O-Warnsound: OFF
SET KEY-CLICK Key click: ON Key click: ON
Only for 4008 H/S Key click: OFF
BPR/UFR-WARNING BPR/UFR-Warning: ON BPR/UFR-Warning: ON
BPR/UFR-Warning: OFF
SET RINSE-VOLUME RINSE-VOL: 1000 ml 1000 ml 0–5000 ml 100 ml
T1-TEST AUTOSTART T1-T. Autostart: OFF T1-T. Autostart: OFF
T1-T. Autostart: ON
ONLINE plus SETTINGS
Only for ONLINEplus™ (optional)
ONLINE plus HD SET UF-Volume F/R 0 ml 0–1000 ml 100 ml
SET Rinsing Volume 1000 ml 0–5000 ml 100 ml
ONLINE plus HDF SET UF-Volume F/R 500 ml 0–1000 ml 100 ml
SET Substit.-Volume 12 L 0–210 L 1L
ONLINE plus HF SET UF-Volume F/R 1000 ml 0–5000 ml 100 ml
SET Substit.-Volume 20 L 0–210 L 1L
ONLINE plus MISC. SET Reinf.-Volume 240 ml 90–480 ml 30 ml
SET CENTRAL-DELIVERY NO central-delivery NO central-delivery
central Bic
central Acid
central Acid + Bic
centr acetate-supply
AutoOFF after AutoON OFF OFF
ON
Init. CAMUS-baudrate 2400 baud 2400 baud
9600 baud
STORE DEFAULT VALUES Press OVERRIDE
Only for 4008 B
Press ALARMTONE MUTE
Only for 4008 H/S

7.2 Overview
CALIBRATION
LM
DIAGNOSTICS
LM
MISCELLANEOUS
LM
Key
SETUP MENU Conf
LM

7.3 Main menu for 4008 B
SETUP MENU
Key
Conf
Key Key
SET ALARM/WARN TIME see part 1 ACTIV. STD UF-DATA Conf see part 12
Conf
Key Key
SETUP CLEANING PGM see part 2 SET STD. PRIME-TIME see part 13
Conf Conf
Key Key
SETUP DILUTION see part 3 SOUND I/O-SWITCH Conf
see part 14
Conf
Key see part 4 Key

HDF-DILUTION BPR/UFR-WARNING see part 15
Conf (option) Conf
Key Key
SET CONDUCT. LIMIT see part 5 SET RINSE-VOLUME Conf see part 16
Conf
Key Key
INFO SOUND ( C-PGM ) Conf
see part 6 T1-TEST AUTOSTART Conf
see part 17
Key Key
SET DIAL PARAMETERS Conf
see part 7 ONLINE plus SETTINGS Conf
see part 18
(option)
Key Key
DIALYSIS TIME Conf see part 8 SET CENTRAL-DELIVERY Conf see part 19
Key Key
CALC.CUMUL.BLOOD-VOL Conf see part 9 AutoOFF after AutoON see part 20
Conf
Key Key
AUTOM. SN-START Conf see part 10 Init. CAMUS-baudrate Conf see part 21
Key Key
ACTIV. MONIT_NTC109 see part 11 STORE DEFAULT VALUES see part 22
Conf Conf
Key

 Part 1: Setting the alarm and warning time
SET ALARM/WARN TIME
Key
Conf
Key
Set ART-AL DELAYTIME Conf
see part 1.1
LM
Key
Set VEN-AL DELAYTIME see part 1.2
Conf
LM
Key
Set FLOW-OFF W-TIME Conf
see part 1.3
LM
Key
Set UF-WARNING-TIME see part 1.4
Conf
LM
Key
Set MUTE-TIME Conf
see part 1.5
LM
Key
Back to menu ? Conf
LM
 Part 1.1: Setting the arterial alarm delay
Set ART-AL DELAYTIME
Key
Conf
Key
Art Al Delay = 5 s Select
Set the desired delay time by

pressing the  keys
(0–5 seconds)
Key
Override
DATA STORED

 Part 1.2: Setting the venous alarm delay
Set VEN-AL DELAYTIME
Key
Conf
Key
Ven Al Delay = 5 s Select

(0–5 seconds)
Key
Override
DATA STORED
 Part 1.3: Setting the flow-off warning time
Set FLOW-OFF W-TIME
Key
Conf
Key
Flow-Off-T = 30 min Select
Set the desired warning time by

(30, 45, 60 min)
Key
Override
DATA STORED
 Part 1.4: Setting the UF warning time
Set UF-WARNING-TIME
Key
Conf
Key
UF-Warn-Time = 10 min Esc

(10, 30 min)
Key
Override
DATA STORED

 Part 1.5: Setting the mute time
Set MUTE-TIME
Key
Conf
Key
MUTE-Time = 1 min Select
Set the desired time by

(1, 2 min)
Key
Override
DATA STORED

 Part 2: Setting up the cleaning program
SETUP CLEANING PGM
Key
Conf
Key see part 2.1

CLEANING Times Conf
LM
Key
Pgm COMBINATION see part 2.2
Conf
LM
Key
Back to menu ? Conf
LM
 Part 2.1: Cleaning times
Note
The default values and the adjustable range for the cleaning times are
not indicated, as they depend on the particular device options.
CLEANING Times
Key
Conf
Key see part 2.1.1

Rinsing TIME Conf
LM
Key
Hotrinse TIME see part 2.1.2
Conf
LM
Key
Disinfection TIME see part 2.1.3
Conf
LM
Key
Rinsing Free TIME see part 2.1.4
Conf
LM
Key
Hot-Disinf TIME see part 2.1.5
Conf
LM
Key
Mandatory Rinse TIME see part 2.1.6
Conf
LM
Key
CITRO-Mandat-Ri-Time see part 2.1.7
Conf
LM
Key see part 2.1.8

INTEGRATED-HR Time Conf
LM
Key
Back to menu ? Conf
LM

 Part 2.1.1: Rinsing Time
Rinsing TIME
Key
Conf
Key
Rinsing Time = xxmin Select

Key
Override
DATA STORED
 Part 2.1.2: Hotrinse Time
Hotrinse TIME
Key
Conf
Key
H-Rinse Time = xxmin Select

Key
Override
DATA STORED
 Part 2.1.3: Disinfection Time
Disinfection TIME
Key
Conf
Key
Disinf. Time = xxmin Select

Key
Override
DATA STORED

 Part 2.1.4: Rinsing Free Time
Rinsing Free TIME
Key
Conf
Key
R.-Free Time = xmin Select

Key
Override
DATA STORED
 Part 2.1.5: Hot disinfection time
Hot-Disinf TIME
Key
Conf
Key
H-Disinf Time= xxmin
Select

Key
Override
DATA STORED
 Part 2.1.6: Mandatory rinse time
Mandatory Rinse TIME
Key
Conf
Key
M-Rinse Time = xxmin Select

Key
Override
DATA STORED

 Part 2.1.7: CITRO mandatory rinse time
CITRO-Mandat-Ri-Time
Key
Conf
Key
CITRO-MRTime = xxmin Select

Key
Override
DATA STORED
 Part 2.1.8: Integrated hot rinse time
INTEGRATED-HR Time
Key
Conf
Key
INT. HR-Time = xxmin Select

Key
Override
DATA STORED
 Part 2.2: Cleaning program combination
Pgm combination
Key
Conf
Key
RINSE Pgm see part 2.2.1
Conf
LM
Key
HOTRINSE Pgm see part 2.2.2
Conf
LM
Key
DISINFECTION Pgm see part 2.2.3
Conf
LM
Key
Back to menu ? Conf
LM

 Part 2.2.1: Rinse program
RINSE Pgm
Key
Conf
Key After approx.

PGM 1: -R- Override DATA STORED 3 seconds
Key
Select
Key After approx.

PGM 2: -R- endless Override DATA STORED 3 seconds
Key
Select
 Part 2.2.2: Hot rinse program
HOTRINSE Pgm
Key
Conf
Key After approx.

PGM 1: -F-HR-C- Override DATA STORED 3 seconds
Key
Select
Key After approx.

PGM 2: -F-HR- Override DATA STORED 3 seconds
Key
Select
Key After approx.

PGM 3: -IHR- Override DATA STORED 3 seconds
Key
Select
Key After approx.

PGM 4: -IHR-C- Override DATA STORED 3 seconds
Key
Select
 Part 2.2.3: Disinfection program
DISINFECTION Pgm
Key
Conf
Key After approx.

PGM 2: -F-HDIS-M- Override DATA STORED 3 seconds
Key
Select
Key After approx.

PGM 3: -F-D-M-HR- Override DATA STORED 3 seconds
Key
Select
Key After approx.

PGM 4: -F-HDIS-M-HR- DATA STORED 3 seconds
Override
Key
Select
Key After approx.

PGM 1: -F-D-M- Override DATA STORED 3 seconds
Key
Select

 Part 3: Dilution for "NO central-delivery", "central Bic"
(see Part 19: Setting the parameters for Central Delivery System on page 7-28)
SETUP DILUTION
Key
Conf
Key After approx.

1+34 DATA STORED 3 seconds
Override
Key
LM
Select
Key After approx.

1+35.83 ( NaCl 20 ) DATA STORED 3 seconds
Override
Key
LM Select
After approx.
1+35.83 ( NaCl 26 ) Key DATA STORED 3 seconds
Override
Key
LM Select
After approx.
1+35.83 ( Belgium ) Key DATA STORED 3 seconds
Override
Key
LM Select
After approx.
1+44 C Key DATA STORED 3 seconds
Override
Key
LM
Select
Key After approx.
1+44 ACF DATA STORED 3 seconds
Override
Key
LM Select
Key see part 3.1

VARIABLE SETTING Conf
LM

 Part 3: Dilution for "central Acid", "central Acid + Bic"
SETUP DILUTION
Key CDS 1+34

Conf
LM After approx.
Key DATA STORED 3 seconds
Key Override
Canister 1+34 ACKNOWLEDGED CDS 1+44 C
Override Key
Select
LM
LM
CDS 1+44 ACF
Key
Select
Key After approx.

Override
Key
LM Select
Key After approx.

Override
Key
LM Select
After approx.
1+35.83 ( Belgium ) Key
DATA STORED 3 seconds
Override
Key
LM Select
CDS 1+34
After approx.
Key DATA STORED
Key 3 seconds
Canister 1+44 C ACKNOWLEDGED Override
Override LM
Key
Select
CDS 1+44 C
LM Key
Select
CDS 1+34
Key After approx.
Key DATA STORED 3 seconds
Canister 1+44 ACF ACKNOWLEDGED Override
Override LM
Key
Select
LM CDS 1+44 ACF
Key
Select
Key see part 3.1

LM

 Part 3: Dilution for "centr acetate-supply"
SETUP DILUTION
Key
Conf
Key After approx.

Canister 1+34 Key ACKNOWLEDGED CDS 1+34 DATA STORED
Override 3 seconds
Override
Key
Select
Key
LM Select
Key Key After approx.

1+35.83 ( NaCl 20 ) ACKNOWLEDGED CDS 1+34 DATA STORED 3 seconds
Override Override
Key
Key Select
LM Select
Key Key After approx.

1+35.83 ( NaCl 26 ) ACKNOWLEDGED CDS 1+34 DATA STORED 3 seconds
Override Override
Key
Key Select
LM Select
Key After approx.

1+35.83 ( Belgium ) Key ACKNOWLEDGED CDS 1+34 DATA STORED 3 seconds
Override Override
Key
Select
Key
LM Select
Key After approx.
Canister 1+44 C Key ACKNOWLEDGED CDS 1+34 DATA STORED
Override 3 seconds
Override
Key
Select
Key
LM Select
Key After approx.
Canister 1+44 ACF Key ACKNOWLEDGED CDS 1+34 DATA STORED
Override 3 seconds
Override
Key
Select
Key
LM Select
Key see part 3.1 Key After approx.
VARIABLE SETTING Conf CDS 1+34 Override DATA STORED 3 seconds
Key
LM Select

 Part 3.1 Freely adjustable dilution
Warning
The operator or technician is informed about his duty of care to enter the
component parameters and settings correctly or to check them and to
set the CD alarm window to the expected conductivity value.
When using the programmable mixing ratio (dilution), make sure to use
the right concentrate.
Using a bibag® in combination with the freely adjustable dilution is not
allowed.
Only enter authorized, programmable mixing ratios (dilutions).
SETUP DILUTION
Key
Conf
LM
Key Key
VARIABLE SETTING Conf B-Comp[part]: 0.800 Select
Set the desired value by

(0.800–2.500)
Key
Override
ACKNOWLEDGED
After approx.
3 seconds
Key
RO[part]: 30.000
Select

(30.000–45.000)
Key
Override
ACKNOWLEDGED
After approx.
3 seconds
Key
HCO3-[mmol]: 25
Select

(25–45)
Key
Override
ACKNOWLEDGED
After approx.
3 seconds
Key
Na(B)[mmol]: 25 Select

(25–80)
Key
Override
DATA STORED
After approx.
3 seconds

 Part 4: Setting up the HDF-DILUTION – only for the ONLINE HDF (option)
HDF-DILUTION
Key
Conf
Key After approx.

HDF–PRE–dilution DATA STORED 3 seconds
Override
Key
Select
Key After approx.

HDF–POST–dilution Override DATA STORED 3 seconds
Key
Select
 Part 5: Setting the conductivity alarm limit
SET CONDUCT. LIMIT
Key
Conf
Key
Cd Limit: 12.8 mS/cm Select

(12.8–14.0 mS/cm)
Key
Override
DATA STORED
After approx.
3 seconds
 Part 6: Info sound for cleaning program
INFO SOUND ( C-PGM )
Key
Conf
Key After approx.

Info Sound: ON DATA STORED 3 seconds
Override
Key
Select
Key After approx.

Info Sound: ON Override DATA STORED 3 seconds
Key
Select

 Part 7: Setting the dialysis parameters
SET DIAL PARAMETERS
Key
Conf
Key
SET Flow Parameter see part 7.1
Conf
LM
Key
SET Temp. Parameter Conf see part 7.2
LM
Key
SET Na/Bic Parameter see part 7.3
Conf
LM
Key
Back to menu ? Conf
LM
 Part 7.1: Setting the dialysate flow
SET Flow Parameter
Key
Conf
Key
Flow[ml/min]: 500 Select

(300, 500, 800)
OR
Value set in Dial.
Key
Override
DATA STORED
After approx.
3 seconds
 Part 7.2: Setting the dialysate temperature
SET Temp. Parameter
Key
Conf
Key
Temp.[°C]: 37.0 Select

(35.0–39.0)
OR
Value set in Dial.
Key
Override
DATA STORED
After approx.
3 seconds

 Part 7.3: Setting the Na/Bic
SET Na/Bic Parameter
Key
Conf
Key
Base Na+ 135mmol Select

(125–150)
OR
Value set in Dial.
Key
Override
ACKNOWLEDGED
After approx.
3 seconds
Key
Prescr. Na+ 135mmol Select

(125–148)
Key
Override
ACKNOWLEDGED
After approx.
3 seconds
Key
Bicarbonate: ±0mmol Select

(+8 to -8)
OR
Value set in Dial.
Key
Override
DATA STORED
After approx.
3 seconds
 Part 8: Dialysis time
DIALYSIS TIME
Key
Conf
Key After approx.

Effect. dialysis time Override
Key
Select
Key After approx.

UF time Override DATA STORED 3 seconds
Key
Select

 Part 9: Cumulated blood volume
CALC.CUMUL.BLOOD-VOL
Key
Conf
Key After approx.

during seq DIAL: YES DATA STORED 3 seconds
Override
Key
Select
Key After approx.

during seq DIAL: NO Override DATA STORED 3 seconds
Key
Select
 Part 10: Automatic Single-Needle start
AUTOM. SN-START
Key
Conf
Key After approx.

autom. SN: OFF Override
Key
Select
Key After approx.

autom. SN: ON Override DATA STORED 3 seconds
Key
Select
 Part 11: Activation of Monit_NTC 109
ACTIV. MONIT_NTC109
Key
Conf
Key After approx.

MONIT_NTC109: YES DATA STORED 3 seconds
Override
Key
Select
Key After approx.

MONIT_NTC109: NO Override DATA STORED 3 seconds
Key
Select
 Part 12: Activation of standard UF data
ACTIV. STD UF-DATA
Key
Conf
Key After approx.

STD UF DATA: NO Override
Key
Select
Key After approx.

STD UF DATA: YES Override DATA STORED 3 seconds
Key
Select
UF Rate: 750 ml/h
UF Goal: 3000 ml
UF Time Left: 4 h

 Part 13: Setting the priming time
SET STD. PRIME-TIME
Key
Conf
Key
Prime-Time = 2min Select

(1–5 min)
Key
Override
DATA STORED
After approx.
3 seconds
 Part 14: Warning sound I/O switch
SOUND I/O-SWITCH
Key
Conf
Key After approx.

I/O-Warnsound: ON DATA STORED 3 seconds
Override
Key
Select
Key After approx.

I/O-Warnsound: OFF Override DATA STORED 3 seconds
Key
Select
 Part 15: Setting the BPR/UFR warning
BPR/UFR-WARNING
Key
Conf
Key After approx.

BPR/UFR-Warning: ON DATA STORED 3 seconds
Override
Key
Select
Key After approx.

BPR/UFR-Warning: OFF Override DATA STORED 3 seconds
Key
Select

 Part 16: Setting the rinse volume
SET RINSE-VOLUME
Key
Conf
Key
RINSE-VOL: 1000 ml Select

(0 to 5000 ml
in increments of 100 ml)
Key
Override
DATA STORED
After approx.
3 seconds
 Part 17: T1 test autostart
T1-TEST AUTOSTART
Key
Conf
Key After approx.

T1-T. Autostart: OFF Override
Key
Select
Key After approx.

T1-T. Autostart: ON Override DATA STORED 3 seconds
Key
Select
 Part 18: Setting ONLINEplus™ – only for ONLINEplus™ (option)
Key
Conf
Key
ONLINE plus HD Conf
see part 18.1
LM
Key
ONLINE plus HDF see part 18.2
Conf
LM
Key
ONLINE plus HF Conf
see part 18.3
LM
Key
ONLINE plus MISC. see part 18.4
Conf
LM
Key
Back to menu ? Conf
LM

 Part 18.1: ONLINEplus™ HD
ONLINE plus HD
Key
Conf
Key see part 18.1.1

SET UF-Volume F/R Conf
LM
Key
SET Rinsing Volume see part 18.1.2
Conf
LM
Key
Back to menu ? Conf
LM
 Part 18.1.1: Setting the UF volume (priming / rinsing)
SET UF-Volume F/R
Key
Conf
Key
Volume[ml]: 0 Select

(0 to 1000)
Key
Override
DATA STORED
After approx.
3 seconds
 Part 18.1.2: Setting the rinse volume
SET Rinsing Volume
Key
Conf
Key

(0 to 5000)
Key
Override
DATA STORED
After approx.
3 seconds

 Part 18.2: ONLINEplus™ HDF
ONLINE plus HDF
Key
Conf
Key
SET UF-Volume F/R see part 18.2.1
Conf
LM
Key
SET Rinsing Volume Conf see part 18.2.2
LM
Key
SET Substit.-Volume see part 18.2.3
Conf
LM
Key
Back to menu ? Conf
LM
SET UF-Volume F/R
Key
Conf
Key

(0 to 1000)
Key
Override
DATA STORED
After approx.
3 seconds
SET Rinsing Volume
Key
Conf
Key

(0 to 5000)
Key
Override
DATA STORED
After approx.
3 seconds

 Part 18.2.3: Setting the substituate volume
SET Substit.-Volume
Key
Conf
Key
Volume[l]: 12 Select

(0 to 210)
Key
Override
DATA STORED
After approx.
3 seconds
 Part 18.3: ONLINEplus™ HF
ONLINE plus HF
Key
Conf
Key see part 18.3.1

LM
Key
Conf
LM
Key
Conf
LM
Key
Back to menu ? Conf
LM
SET UF-Volume F/R
Key
Conf
Key

(0 to 5000)
Key
Override
DATA STORED
After approx.
3 seconds

SET Rinsing Volume
Key
Conf
Key

(0 to 5000)
Key
Override
DATA STORED
After approx.
3 seconds
SET Substit.-Volume
Key
Conf
Key
Volume[l]: 20 Select

(0 to 210)
Key
Override
DATA STORED
After approx.
3 seconds
 Part 18.4: ONLINEplus™ miscellaneous
ONLINE plus MISC.
Key
Conf
Key
SET Reinf.-Volume see part 18.4.1
Conf
LM
Key
Back to menu ? Conf
LM

 Part 18.4.1: Setting the reinfusion volume
SET Reinf.-Volume
Key
Conf
Key

(90 to 480)
Key
Override
DATA STORED
After approx.
3 seconds
 Part 19: Setting the parameters for Central Delivery System
SET CENTRAL-DELIVERY
Key
Conf
After approx. After approx.

NO central-delivery Key SETUP DILUTION DATA STORED
3 seconds 3 seconds
Override
LM Key
Select
Key After approx. After approx.
central Bic SETUP DILUTION 3 seconds
Override
LM Key
Select
After approx. After approx.
central Acid Key SETUP DILUTION 3 seconds DATA STORED 3 seconds
Override
LM Key
Select
central Acid + Bic Override
SETUP DILUTION 3 seconds DATA STORED 3 seconds
LM Key
Select
centr acetate-supply SETUP DILUTION 3 seconds DATA STORED 3 seconds
Override
LM Key
Select
 Part 20: AutoOFF after AutoON
AutoOFF after AutoON
Key
Conf
Key After approx.

Auto OFF: OFF Override
Key
Select
Key After approx.

Auto OFF: ON Override DATA STORED 3 seconds
Key
Select

 Part 21: CAMUS-baudrate
Init. CAMUS-baudrate
Key
Conf
Key After approx.

Baud rate: 2400 baud Override
Key
Select
Key After approx.

Baud rate: 9600 baud Override DATA STORED 3 seconds
Key
Select
 Part 22: Storing the default values
STORE DEFAULT VALUES
Key
Conf
Key
Press OVERRIDE Select
Press
the Override key
to store
the default values
DATA STORED
After approx.
3 seconds

7.4 Main menu for 4008 H/S
SETUP MENU
Key
Conf
Key Key
SET ALARM/WARN TIME see part 1 ACTIV. STD UF-DATA Conf see part 13
Conf
Key Key see part 14

SETUP CLEANING PGM see part 2 SET STD. PRIME-TIME
Conf Conf
Key Key
see part 3 SOUND I/O-SWITCH see part 15
SETUP DILUTION Conf Conf
Key see part 4 Key

HDF-DILUTION SET KEY-CLICK see part 16
Conf (option) Conf
Key Key
SET CONDUCT. LIMIT see part 5 BPR/UFR-WARNING Conf see part 17
Conf
Key Key
INFO SOUND ( C-PGM ) see part 6 SET RINSE-VOLUME Conf see part 18
Conf
Key Key
SET DIAL PARAMETERS see part 7 T1-TEST AUTOSTART Conf
see part 19
Conf
Key Key
CALC.CUMUL.BLOOD-VOL see part 8 ONLINE plus SETTINGS Conf
see part 20
Conf (option)
Key see part 9 Key

HAEMOGLOBIN UNIT Conf (option)
SET CENTRAL-DELIVERY Conf see part 21
Key see part 10 Key

OCM SETTINGS (option) AutoOFF after AutoON Conf
see part 22
Conf
Key Key
AUTOM. SN-START see part 11 Init. CAMUS-baudrate see part 23
Conf Conf
Key see part 12 Key

ACTIV. MONIT_NTC109 Conf STORE DEFAULT VALUES see part 24
Conf
Key

 Part 1: Setting the alarm and warning time
SET ALARM/WARN TIME
Key
Conf
Key
Set ART-AL DELAYTIME Conf
see part 1.1
LM
Key
Set VEN-AL DELAYTIME see part 1.2
Conf
LM
Key
Set FLOW-OFF W-TIME Conf
see part 1.3
LM
Key
Set UF-WARNING-TIME see part 1.4
Conf
LM
Key
Set MUTE-TIME Conf
see part 1.5
LM
Key
Back to menu ? Conf
LM
 Part 1.1: Setting the delay time of the arterial alarm
Set ART-AL DELAYTIME
Key
Conf
Key
Art Al Delay = 5 s Esc

(0–5 seconds)
Key
ALARMTONE MUTE
DATA STORED

 Part 1.2: Setting the delay time of the venous alarm
Set VEN-AL DELAYTIME
Key
Conf
Key
Ven Al Delay = 5 s Esc

(0–5 seconds)
Key
ALARMTONE MUTE
DATA STORED
 Part 1.3: Setting the flow-off warning time
Set FLOW-OFF W-TIME
Key
Conf
Key
Flow-Off-T = 30 min Esc

(30, 45, 60 min)
Key
ALARMTONE MUTE
DATA STORED
 Part 1.4: Setting the UF warning time
Set UF-WARNING-TIME
Key
Conf
Key
UF-Warn-Time = 10 min Esc

(10, 30 min)
Key
ALARMTONE MUTE
DATA STORED

 Part 1.5: Setting the mute time
Set MUTE-TIME
Key
Conf
Key
MUTE-Time = 1 min Esc

(1, 2 min)
Key
ALARMTONE MUTE
DATA STORED
 Part 2: Setting up the cleaning program
SETUP CLEANING PGM
Key
Conf
Key see part 2.1

CLEANING Times Conf
LM
Key
DEFAULT Cleaning Pgm see part 2.2
Conf
LM
Key
Back to menu ? Conf
LM

 Part 2.1: Cleaning times
Note
The default values and the adjustable range for the cleaning times are
not indicated, as they depend on the particular device options.
CLEANING Times
Key
Conf
Key see part 2.1.1

Rinsing TIME Conf
LM
Key
Hotrinse TIME Conf
see part 2.1.2
LM
Key
Disinfection TIME see part 2.1.3
Conf
LM
Key
Rinsing Free TIME see part 2.1.4
Conf
LM
Key
Hot-Disinf TIME see part 2.1.5
Conf
LM
Key
Mandatory Rinse TIME see part 2.1.6
Conf
LM
Key
CITRO-Mandat-Ri-Time see part 2.1.7
Conf
LM
Key see part 2.1.8

INTEGRATED-HR Time Conf
LM
Key
Back to menu ? Conf
LM
 Part 2.1.1: Rinsing Time
Rinsing TIME
Key
Conf
Key
Rinsing Time = xxmin Esc

(5–30 min)
Key
ALARMTONE MUTE
DATA STORED

 Part 2.1.2: Hotrinse Time
Hotrinse TIME
Key
Conf
Key
H-Rinse Time = xxmin Esc

Key
ALARMTONE MUTE
DATA STORED
 Part 2.1.3: Disinfection Time
Disinfection TIME
Key
Conf
Key
Disinf. Time = xxmin Esc

Key
ALARMTONE MUTE
DATA STORED
 Part 2.1.4: Rinsing Free Time
Rinsing Free TIME
Key
Conf
Key
R.-Free Time = xmin Esc

Key
ALARMTONE MUTE
DATA STORED

 Part 2.1.5: Hot disinfection time
Hot-Disinf TIME
Key
Conf
Key
H-Disinf Time= xxmin Esc

Key
ALARMTONE MUTE
DATA STORED
 Part 2.1.6: Mandatory rinse time
Mandatory Rinse TIME
Key
Conf
Key
M-Rinse Time = xxmin Esc

Key
ALARMTONE MUTE
DATA STORED
 Part 2.1.7: CITRO mandatory rinse time
CITRO-Mandat-Ri-Time
Key
Conf
Key
CITRO-MRTime = xxmin Esc

Key
ALARMTONE MUTE
DATA STORED

 Part 2.1.8: Integrated hot rinse time
INTEGRATED-HR Time
Key
Conf
Key
INT. HR-Time = xxmin Esc

Key
ALARMTONE MUTE
DATA STORED
 Part 2.2: Default cleaning programs
DEFAULT Cleaning Pgm
Key
Conf
Key ALARM- After approx.

PGM 1: -R- TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

PGM 2: -R- endless TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

PGM 1: -F-HR-C- TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

PGM 2: -F-HR- TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

PGM 3: -IHR- TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

PGM 4: -IHR-C- TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

PGM 1: -F-D-M- TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

PGM 2: -F-HDIS-M- TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

PGM 3: -F-D-M-HR- TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

PGM 4: -F-HDIS-M-HR- TONE MUTE
Key
+/– Esc

 Part 3: Dilution for "NO central-delivery", "central Bic"
SETUP DILUTION
Key
Conf

Canister 1+34 TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

TONE MUTE
Key
+/– Esc

TONE MUTE
Key
+/– Esc

1+35.83 ( Belgium ) TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

Canister 1+44 C TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

Canister 1+44 ACF TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
Key see part 3.1

+/–

 Part 3: Dilution for "central Acid", "central Acid + Bic"
SETUP DILUTION
CDS 1+34
Key
Conf
+/– Key ALARM- After approx.
TONE MUTE DATA STORED 3 seconds
Key ALARM-
Canister 1+34 TONE MUTE ACKNOWLEDGED CDS 1+44 C
Key
Esc
+/–
+/–
CDS 1+44 ACF
Key
Esc

1+35.83 ( NaCl 20 ) TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

1+35.83 ( NaCl 26 ) TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

1+35.83 ( Belgium ) TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
CDS 1+34
Key ALARM- TONE MUTE
Canister 1+44 C ACKNOWLEDGED +/–
TONE MUTE Key
Esc
CDS 1+44 C
+/– Key
Esc
CDS 1+34
Key ALARM- TONE MUTE DATA STORED 3 seconds
Canister 1+44 ACF TONE MUTE ACKNOWLEDGED +/–
Key
Esc
+/– CDS 1+44 ACF
Key
Esc
Key
VARIABLE SETTING Conf see part 3.1
+/–

 Part 3: Dilution for "centr acetate-supply"
SETUP DILUTION
Key
Conf
Key ALARM- Key ALARM- After approx.

Canister 1+34 TONE MUTE
ACKNOWLEDGED CDS 1+34 TONE MUTE DATA STORED 3 seconds
Key
Key Esc
+/– Esc

1+35.83 ( NaCl 20 ) TONE MUTE
ACKNOWLEDGED CDS 1+34 TONE MUTE DATA STORED 3 seconds
Key
Key Esc
+/– Esc

1+35.83 ( NaCl 26 ) TONE MUTE ACKNOWLEDGED CDS 1+34 TONE MUTE DATA STORED 3 seconds
Key
Esc
Key
+/– Esc

1+35.83 ( Belgium ) TONE MUTE ACKNOWLEDGED CDS 1+34 TONE MUTE DATA STORED 3 seconds
Key
Esc
Key
+/– Esc

Canister 1+44 C TONE MUTE ACKNOWLEDGED CDS 1+34 TONE MUTE DATA STORED 3 seconds
Key
Key Esc
+/– Esc

Canister 1+44 ACF TONE MUTE ACKNOWLEDGED CDS 1+34 TONE MUTE DATA STORED 3 seconds
Key
Key Esc
+/– Esc
Key Key ALARM- After approx.

see part 3.1
VARIABLE SETTING Conf CDS 1+34 TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

 Part 3.1 Freely adjustable dilution
Warning
The operator or technician is informed about his duty of care to enter the
component parameters and settings correctly or to check them and to
set the CD alarm window to the expected conductivity value.
When using the programmable mixing ratio (dilution), make sure to use
the right concentrate.
Using a bibag® in combination with the freely adjustable dilution is not
allowed.
Only enter authorized, programmable mixing ratios (dilutions).
SETUP DILUTION
Key
Conf
+/–
Key Key
VARIABLE SETTING Conf B-Comp[part]: 0.800 Esc

(0.800–2.500)
Key
ALARMTONE MUTE
ACKNOWLEDGED
After approx.
3 seconds
Key
RO[part]: 30.000
Esc

(30.000–45.000)
Key
ALARMTONE MUTE
ACKNOWLEDGED
After approx.
3 seconds
Key
HCO3-[mmol]: 25
Esc

(25–45)
Key
ALARMTONE MUTE
ACKNOWLEDGED
After approx.
3 seconds
Key
Na(B)[mmol]: 25 Esc

(25–80)
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds

 Part 4: Setting up the HDF-DILUTION – only for the ONLINE HDF (option)
HDF-DILUTION
Key
Conf

HDF–PRE–dilution TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
HDF–POST–dilution TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
 Part 5: Setting the conductivity alarm limit
SET CONDUCT. LIMIT
Key
Conf
Key
Cd Limit: 12.8 mS/cm Esc

(12.8–14.0 mS/cm)
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds
 Part 6: Info sound for cleaning program
INFO SOUND ( C-PGM )
Key
Conf

Info Sound: ON TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
Info Sound: OFF TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

 Part 7: Setting the dialysis parameters
SET DIAL PARAMETERS
Key
Conf
Key
SET Flow Parameter see part 7.1
Conf
LM
Key
SET Temp. Parameter Conf
see part 7.2
LM
Key
SET Na/Bic Parameter see part 7.3
Conf
LM
Key
Back to menu ? Conf
LM
 Part 7.1: Setting the dialysate flow
SET Flow Parameter
Key
Conf
Key
Flow[ml/min]: 500 Esc

(300, 500, 800)
OR
Value set in Dial.
Key ALARMTONE MUTE
DATA STORED
After approx.
3 seconds
 Part 7.2: Setting the dialysate temperature
SET Temp. Parameter
Key
Conf
Key
Temp.[°C]: 37.0 Esc

(35.0 to 39.0)
OR
Value set in Dial.
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds

 Part 7.3: Setting the Na/Bic
SET Na/Bic Parameter
Key
Conf
Key
Base Na+ 135mmol Esc

(125–150)
OR
Value set in Dial.
Key
ALARMTONE MUTE
ACKNOWLEDGED
After approx.
3 seconds
Key
Prescr. Na+ 135mmol Esc

(125–148)
Key
ALARMTONE MUTE
ACKNOWLEDGED
After approx.
3 seconds
Key
Bicarbonate: ±0mmol Esc

(+8 to -8)
OR
Value set in Dial.
Key
ALARMTONE MUTE
ACKNOWLEDGED
After approx.
3 seconds
Key
Limit Na/Base 13mmol Esc

(0-13)
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds

 Part 8: Cumulated blood volume
CALC.CUMUL.BLOOD-VOL
Key
Conf

during seq DIAL: YES TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
during seq DIAL: NO TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
 Part 9: Haemoglobin unit – only for BVM (option)
HAEMOGLOBIN UNIT
Key
Conf

g/dl TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
mmol/l TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
 Part 10: OCM settings – only for OCM (option)
OCM SETTINGS
Key
Conf
Key
OCM MEASUREMENT Conf
see part 10.1
LM
Key
OCM ZERO MEASUREMENT Conf
see part 10.2
LM
Key
OCM MEASURE DEL.TIME see part 10.3
Conf
LM
Key
OCM CLR CORR FACTOR Conf
see part 10.4
LM
Key
OCM BASELINE DIFF. Conf
see part 10.5
LM
Key
OCM INTEGRAL VALUE see part 10.6
Conf
LM
Key
OCM KT/V WARNLEVEL see part 10.7
Conf
LM
Key
Back to menu ? Conf
LM

 Part 10.1: Activating the OCM measurement
OCM MEASUREMENT
Key
Conf

OCM Measurement: OFF TONE MUTE DATA STORED 3 seconds
(default value: Key
OFF) +/– Esc
OCM Measurement: ON TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
 Part 10.2: Activating the OCM zero measurement
Note
If the OCM zero measurement is set to "OFF", the OCM option is
deactivated.
If the OCM option is reactivated ("ON"), an OCM pulse calibration must
be performed.
OCM ZERO MEASUREMENT
Key
Conf

OCM zero measurement: ON TONE MUTE DATA STORED 3 seconds
(default value: Key
ON) +/– Esc
OCM zero measurement: OFF TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
 Part 10.3: Setting the OCM measurement delay time
Device Time
4008 H with HPU 15 seconds
4008 H with ONLINEplus™ 65 seconds
4008 S with HPU 18 seconds
4008 S with ONLINEplus™ 67 seconds

OCM MEASURE DEL.TIME
Key
Conf
Key
Delaytime: XX s Esc
Press +/- to set the value indicated in the

adjacent table
(1–70 seconds)
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds
 Part 10.4: Setting the OCM correction factor
Note
Do not change the default value.
Note
The 4008 H/S offers the theoretical possibility of defining a correction
value for all clearance measurements. This allows the device to be
adapted on site to incorporate new findings from ongoing scientific
research. According to the current standard of knowledge, this
correction value has to be set to "1" (factory setting) for Fresenius
polysulfone membranes. The indicated accuracy specifications are
valid only for Fresenius polysulfone membrane combined with this
correction value setting of "1".
OCM CLR CORR FACTOR
Key
Conf
Key
ClrCorr factor:1.000 Esc
Display
shows the
default value
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds
 Part 10.5: Setting the OCM baseline difference
Note

OCM BASELINE DIFF.
Key
Conf
Key
Baseline Diff.:0.015 Esc
Display
shows the
default value
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds
 Part 10.6: Setting the OCM integral value
Note
OCM INTEGRAL VALUE
Key
Conf
Key
Integral value: 55 Esc
Display
shows the
default value
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds
 Part 10.7: Setting the OCM Kt/V warning level
OCM KT/V WARNLEVEL
Key
Conf
Key
Kt/V Warnlevel: 85% Esc
Press +/- to set the

warning limit
(default value: 85)
Range 0–99%
0 = no warning
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds

 Part 11: Automatic Single-Needle start
AUTOM. SN-START
Key
Conf

autom. SN: OFF TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
autom. SN: ON TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
 Part 12: Activation of Monit_NTC 109
ACTIV. MONIT_NTC109
Key
Conf

MONIT_NTC109: YES TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
MONIT_NTC109: NO TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
 Part 13: Activation of standard UF data
ACTIV. STD UF DATA
Key
Conf

STD UF DATA: NO TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
STD UF DATA: YES TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
UF Rate: 750 ml/h
UF Goal: 3000 ml
UF Time Left: 4 h

 Part 14: Setting the priming time
SET STD. PRIME-TIME
Key
Conf
Key
Prime-Time = 2min Esc

(1–5 min)
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds
 Part 15: Warning sound I/O switch
SOUND I/O-SWITCH
Key
Conf

I/O-Warnsound: ON TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
I/O-Warnsound: OFF TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
 Part 16: Setting the key-click
SET KEY-CLICK
Key
Conf

Key click: ON TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
Key click: OFF TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
 Part 17: Setting the BPR/UFR warning
BPR/UFR-WARNING
Key
Conf

BPR/UFR-Warning: ON TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
BPR/UFR-Warning: OFF TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

 Part 18: Setting the rinse volume
SET RINSE-VOLUME
Key
Conf
Key
RINSE-VOL: 1000 ml Esc
Use +/- to set the desired

rinse volume
(0 to 5000 ml
in increments of 100 ml)
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds
 Part 19: T1 test autostart
T1-TEST AUTOSTART
Key
Conf

T1-T. Autostart: OFF TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
T1-T. Autostart: ON TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
 Part 20: Setting ONLINEplus™ – only for ONLINEplus™ (option)
Key
Conf
Key
ONLINE plus HD Conf
see part 20.1
LM
Key
ONLINE plus HDF see part 20.2
Conf
LM
Key
ONLINE plus HF Conf
see part 20.3
LM
Key
ONLINE plus MISC. see part 20.4
Conf
LM
Key
Back to menu ? Conf
LM

 Part 20.1: ONLINEplus™ HD
ONLINE plus HD
Key
Conf
Key see part 20.1.1

LM
Key
Conf
LM
Key
Back to menu ? Conf
LM
SET UF-Volume F/R
Key
Conf
Key
Volume[ml]: 0 Esc

(0 to 1000)
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds
SET Rinsing Volume
Key
Conf
Key
Volume[ml]: 1000 Esc

(0 to 5000)
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds

 Part 20.2: ONLINEplus™ HDF
ONLINE plus HDF
Key
Conf
Key
Conf
LM
Key
LM
Key
Conf
LM
Key
Back to menu ? Conf
LM
SET UF-Volume F/R
Key
Conf
Key
Volume[ml]: 500 Esc

(0 to 1000)
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds
SET Rinsing Volume
Key
Conf
Key

(0 to 5000)
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds

SET Substit.-Volume
Key
Conf
Key
Volume[l]: 12 Esc

(0 to 210)
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds
 Part 20.3: ONLINEplus™ HF
ONLINE plus HF
Key
Conf
Key
Conf
LM
Key
LM
Key
Conf
LM
Key
Back to menu ? Conf
LM
SET UF-Volume F/R
Key
Conf
Key

(0 to 5000)
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds

SET Rinsing Volume
Key
Conf
Key

(0 to 5000)
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds
SET Substit.-Volume
Key
Conf
Key
Volume[l]: 20 Esc

(0 to 210)
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds
 Part 20.4: ONLINEplus™ miscellaneous
ONLINE plus MISC.
Key
Conf
Key
SET Reinf.-Volume see part 20.4.1
Conf
LM
Key
Back to menu ? Conf
LM

 Part 20.4.1: Setting the reinfusion volume
SET Reinf.-Volume
Key
Conf
Key
Volume[ml]: 240 Esc

(90 to 480)
Key
ALARMTONE MUTE
DATA STORED
After approx.
3 seconds
 Part 21: Setting the parameters for Central Delivery System
Note
Central delivery is not available for the 3mix option.
SET CENTRAL-DELIVERY
Key
Conf
Key ALARM- After approx. After approx.

NO central-delivery TONE MUTE SETUP DILUTION 3 seconds DATA STORED 3 seconds
Key
+/– Esc
central Bic TONE MUTE SETUP DILUTION 3 seconds
Key
+/– Esc
central Acid TONE MUTE SETUP DILUTION 3 seconds DATA STORED 3 seconds
Key
+/– Esc

central Acid + Bic TONE MUTE SETUP DILUTION DATA STORED 3 seconds
3 seconds
Key
+/– Esc
centr acetate-supply TONE MUTE SETUP DILUTION 3 seconds DATA STORED 3 seconds
Key
+/– Esc
 Part 22: AutoOFF after AutoON
AutoOFF after AutoON
Key
Conf

Auto OFF: OFF TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
Auto OFF: ON TONE MUTE DATA STORED 3 seconds
Key
+/– Esc

 Part 23: CAMUS-baudrate
Init. CAMUS-baudrate
Key
Conf

Baud rate: 2400 baud TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
Baud rate: 9600 baud TONE MUTE DATA STORED 3 seconds
Key
+/– Esc
 Part 24: Storing the default values
STORE DEFAULT VALUES
Key
Conf
Key
Press ALARMTONE MUTE Esc
Press the ALARMTONE

MUTE key to store
the default values
DATA STORED
After approx.
3 seconds


Chapter 8: Miscellaneous
8 Miscellaneous
CALIBRATION
LM
DIAGNOSTICS
LM
Key
MISCELLANEOUS Conf
LM
SETUP MENU
LM
 Main menu
Service switch to
MISCELLANEOUS Treatment
Key Key
Conf Conf
Key Key
SYSTEM CLOCK Conf see part 1 SW-VERSION-NUMBER Conf see part 2
LM LM
Key Key
BACK TO MAIN MENU ? Conf SYSTEM CLOCK Conf see part 1
LM LM
Key
LM

Chapter 8: Miscellaneous
 Part 1
SYSTEM CLOCK
Key
Conf
Time Date
Key
XX:XX:XX XX:XX:XXXX Select
(Esc)
Press the  (+/-) keys to set
the flashing hours
Key
Conf
Press the  (+/-) keys to set

the flashing minutes
Key
Conf
Press the  (+/-) keys to set the

seconds, day, month, and year in
the same way
Key
Override (ALARMTONE MUTE)
DATA STORED
After approx.
3 seconds
 Part 2
SW-VERSION-NUMBER
Key
Conf
Key
CPU_1-Ver-No.: X.XX Select
(Esc)
LM (+/–)
Key
CPU_2-Ver-No.: X.XX Select
(Esc)
LM (+/–)
Key
MDC-Ver-No.: X.XX Select
(Esc)
LM (+/–)
Key
HPU-Ver-No.: X.XX Select
(Esc)
LM (+/–)
Key
Online-Vers.: X.XX Select
(Esc)
LM (+/–)
Key
BVM-Ver-No.: X.XX Select
(Esc)
LM (+/–)

9
9.1
+24V_SW
+5V +12V +5V +12V +5V +12V +5V +24V_US

Watchdog-Ausgang
PWR_WD Watchdog output
LP 633 LP 634 4008 B: LP 649 zum Display
LP 631

Input Output 4008 S: LP 922 to display
CPU 1 4008 H: LP 924
board board
Display
board
Block diagram 4008
Netzteil
serielle 4008
+24V_SW +24V_EM
4008 B / 4008 H / 4008 S

Schnittstelle
serial +12V +12V Power
interface Supply Akku
+24V_SW 4008 Battery
Power Board
TM-EN
+5V +12V Hydraulik Einschübe
Hydraulic Modules Heater Board
WD-Set 230V 24V_US
WD-Reset +5V
LP 632 Watchdog +12V
CPU 2
12A-2016
+24V_SW
+24V_EM
Circuit diagrams and circuit descriptions
9-1
Chapter 9: Circuit diagrams and circuit descriptions
9.2 Voltage supply block diagram

9.3
RAM
Speicher
RS232 CPU

ROM
Speicher
CPU II LP632
RS232
RAM
RS232 CPU
X639
4008 B / 4008 H / 4008 S

24V_US
ROM
Power logic CPU I LP631
LP647 (4008S)
LP639 (4008H) Motherboard LP630
TM-EN
U-ACCU
24V_US
Adress-/Databus
Block diagram of screen 4008 H/S
MDC-Board TFT-Display
Display board
12A-2016
LP922 (4008S) ROM
LP 924 (4008H)
RS232
Video
RAM DRAM
Video Video Signal

RS232 RS232 CPU
Controller
24V_US
Power Backlight
Supply U Backlight Backlight
Inverter
Trafic Light LP923
9-3
9-4
9.4
Rate: ml/min Rate: ml/min Rate: ml/h
(Ø: mm) (Ø: mm) (Bolus: ml)
( :h.min) Pven.
Bolus
Start Start
Stop Stop Rate
Start
Stop
XA1 UF pump 22
LP 928/774
Kurz- Flow pump 21
CAN-BUS Verteiler
schluß- Degassing pump 29
Art SN CAN-BUS Distribution
Diagnose teil Air separation pump 97
Diagnosis Shunt XA2 Valves V24 V24B V26 V30 V41 V43 V84
LP 624 LP 624 LP 643-3 LP 450
interlock X M9 X 1/774 V91 V112
X 348 X 348 LP 950 LP 450-2
X 6/928 XA3 Balancing chamber valves V31–V38
ST 1 X 351
Valves V86 V87
XA4 CDS V99 V100 V102 V104 V126 V130
XA5 V183 V188 V189 V9
Compressor 185
X DIAG X CAN X 637A X 348A X 348V X 350 X 351 X SHUNT CO1 Concentrate pump
Sensoren / Sensors
BI1 Bicarbonate pump
XR1 OCM_NTC 4
LP 636 X ACDA XR2 V84 sensor
Pumpen / Pumps XR3 Bibag pressure switch
Extern X 636 X 637B
I/O X2 NTC2
Ventile / Valves
X HDF X3 NTC3
HPU wiring diagram
X5 Float switch
LP 632 X 637C X6 Level sensor 6
CPU 2
X 632
X CAN
X 633L
X 634L
X7 Conductivity measuring cell
X8 Dialysate pressure transducer 1
X ACCU
Akku
Accu X9 Reed contact 10 concentrate
X10 Pressure switch CDS

LP 633 LP 634 X11 Bibag
X PWR
Input Output X12 Bibag NTC 133
board board X13 Bibag conductivity measuring cell
Netzteil X14 NTC109
4008 X15 OCM conductivity measuring cell 110
X RS
Power XS1 Dialysate pressure transducer 2 (182)
Supply LP 763
XS2 NC
LP 631 Multi

4008 XS3 NC
CPU 1 Interface
X63Z
X 631
X 639A
XS4 NC
X 633R
X 634R
Board
XS5 Level sensor concentrate 202
XS6 NTC INDI 308
XS7 INDI conductivity measuring cell 309
X 635
LP 630
Motherboard
Display
board X 82 X C1 X A7 X1
X S1 P-Dial 2
Pumpen Ventile Sensoren CAN
X S2 NC
N.C.
X R1 OCM_NTC4 X2 NTC2 X 16 X S3 NC
Conc.P. Bic.P.
4008 B / 4008 H / 4008 S

X 15 OCM_LF110 X3 NTC3 X 17 X S4 NC
CO1 BI1 Verteiler-
X 14 NTC109 X5 FL-Switch 5 X S5 Niveau Konz.
platine
X 13 LF-Bibag 108 X6 Niveau 6 Distribution X S6 NTC308
X A5 X A1 X A2 board
X 12 Bibag NTC107 X7 LF 7 X S7 LF309
X A6 X A4 X A3 X 11 Bibag X8 P-Dial 1 (9) X R3 Bibag SW
TM-EN
X 10 ZKV PSW X9 Reedk. 10 X B1 X R2 V89 Sens.
LP 941 Blutleckdetektor
Wasserteilrechner / Hydraulic Processing Unit Blood Leak Detector
12A-2016
9.4.1 Connection diagram CAN communication

9.4.2 Hydraulics processor block diagram

9.5 PCB LP450-2 Level detector control (LD)
Fig.: Signal plan PCB LP450-2
US-Sender LP 450-2
US-Transmitter
X156 20 +24V
19 +24V
18 0 (24V)
X155 0 (24V)
17
16 +12V
US-Empfänger 0 (12V)
15
US-Receiver
14 LDA1 = L
1 13 Niveau senken / Level down = H
2 X154 Dialyse Start / Dialysis start = H
3 12
11 n.c.
Niveau heben/senken
X351 LDSA = H
Level up/down 10
9 Potentialausgleich / Ground
1
2 8 Klemme zu, Clamp closed = L
LP 248 X160 ODSA = H
3 7
4 6 LDA2 = H
5 OD: hell/light = dunkel/dark = L

Optischer Detektor
Optical detector 4 Pven 0 – 10 V
1 3 Spiegel heben / Level up

X159 2 Pven-Verstimmung / Pven detune
2 Belüftungsventil, auf / Vent valve, open = H
Belüftungsventil 1
Vent valve
1
2 X161
3
Venöse Klemme
Venous clamp
1
M X153
2
Membranpumpe
Membrane pump
X157
Potentialausgleich
Ground

31.07.14

9.6 PCB LP493 Blood leak detector
02.04.14

9.7 PCB LP624 Control board (BP)

9.8


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9-11
9.9 PCB LP 631 CPU1
Fig.: Block diagram PCB LP631 CPU1
WATCHDOG
RTC
2 CHANNEL
SIO
LED's
512 KByte
EPROM
DIP-SW2
DIP-SW1
BATRAM
8 KByte
PAL
128 KByte
RAM
Address bus
Control bus
Data bus
Addresses Data
controller
Micro-
80188


9-14
Crystal-controlled 512 kByte 8 kByte 32 kByte
Reference oscillator EPROM NOVRAM SRAM U-REF
voltage 10 MHz (FLASH) 5V
5V
U-REF 5V
9- 6-
ANALOG DAC
inputs outputs
ANALOG
C515C
Fig.: Block diagram PCB LP632 CPU2
Micro-
Control bus
9.10 PCB LP 632 CPU2
controller 8-
16-
DIGITAL DIGITAL
inputs outputs
PORT
(DIRECT) Adress bus (BUFFER)
ADRESSES
2x8 8-
DIP Data bus POWER
SWITCH outputs
DATA
(BUFFER) (BUFFER)

Tx
serial interface
24- Rx 8x
DIGITAL Status
inputs LED's
(BUFFER) (BUFFER)
8-
DIGITAL
outputs
PORT
(DIRECT)
4008 B / 4008 H / 4008 S

Control bus
Data bus
TM-EN
12A-2016
05.12.12

9.11 PCB LP 633 Input board
Fig.: Block diagram PCB LP633
analog digital
ADC's HDF_ON BUFFER's COND_V84

PWR_WD V102 LDA1
BUFFER 6
V104 MF OD_OUT
BUFFER 0
P_V102 CSS_REED FL_SWITCH_+5V
5V/12V
SPARE CI
P_VEN SPARE ABG_BYP
SPARE ABG_ON
ADC 0
BPR_VEN SPARE MF ABG_ALARM
BPR_ART
V43
VEN_BPR_SET V26
BUFFER 7
BUFFER 1
V24B
ART_BPR_SET V24
LD_SERIAL
UF_P1
Uref LDA2
SUB_W_P
SPARE
U_ACCU REED_BIC
BIBAG
BUFFER 2
P_V104 REED_RINSE
BIBAG_C
24V_EM PSW_V102
PSW_V104
ADC 1
P_ART PWR_OFF
HEP_ON
BLL_DIM
SPARE
BLL/BLL_OLD SW_ON_OFF
BUFFER 3 PWR_FAIL
COND_SIGNAL SHUNT_OUTP
SHUNT_INP
Uref SHUNT
SERV_EN
LEV_SIGNAL
SPARE SN
ADKS
BUFFER 4
TEMP_DIAL2 BPSB_ART
BPUS_ART
COND_SIGNAL2 BPSB_VEN
BPUS_VEN
ADC 2
BIBAG_TEMP HEP_ALARM
BIB_LEVEL
BIBAG_COND
EXT_ALARM
SPARE SERVICE_MODE
BUFFER 5
LEVEL UP
U_BATT_SW LEVEL DOWN
ADS_SN
Uref ACKN_CONC
ACKN_BIC
BIBAG_PSW
Microprocessor Interface
STEUER–BUS
DATEN–BUS
ADR–BUS
CPU 1

18.10.10

9.12 PCB LP 634 Output board
Fig.: PCB LP 634 Output board block diagram

EN1
Latch +AIRSEP_P
UF_P_CTRL UF_P1
UF_P_EN
UF_P2_CTRL UF_P2
EN2 V31 V35

V32 V36
Latch GAL V33 V37
V34 V38
EN3
Latch CONC_P
Micro-
control-
EN4 ler
Latch BIC_P
&
EN_CPU2
EN6 V24
& V24 V91
V24B V24b V102
Latch V26 V126
Control bus
Address V87 V130
decodin
Address bus
g logic
EN7
V30 V86
Latch V41 V99
V43 V104
Data bus Bus V84
driver
EN8
SN_EN HDF_LOG1
Latch SNST PROG_LOG2
CPU_OFF VENT_VALVE
V_ADS
EN9 CLR_ALARM CPU_AKKU

HOT_RINSE HEAT_OFF
Latch TEST_BATT STAFF_CALL
TL_RED
EN10 BPST_ART BPSST_VEN

BPSST_ART HDF_SEL
Latch CLAMP_CTRL TL_YELLOW
BPST_VEN TL_GREEN
EN5
Latch GAL
Oscilla-
tor
EN11
Latch Counter FLOW_P
D/A DEGAS_P
TEMP_SET DAC_BLL
DAC_DIM DAC_X
TEMP_ADJ DAC_P_ZE
U_ref STEUER_EP BIBAG_TEMP_AJ
STEUER_FP
EN12 V_ZKV1
Latch V_ZKV2
VY5
FREE_OUTP

16.03.12
entf.

9.13 PCB LP 636 External connectors

9-21 12A-2016 TM-EN 4008 B / 4008 H / 4008 S Fresenius Medical Care
COPYING OF THIS DOCUMENT, AND GIVING IT TO OTHERS AND THE
USE OR COMMUNICATION OF THE CONTENTS THEREOF ARE FORBIDDEN
WITHOUT EXPRESS AUTHORITY. OFFENDERS ARE LIABLE TO THE PAYMENT
SCHUTZVERMERK NACH OF DAMAGES. ALL RIGHTS ARE RESERVED IN THE EVENT OF THE GRAND
DIN 34 BEACHTEN. OF A PATENT OR THE REGISTRATION OF A UTILITY MODEL OR DESIGN.
F
A
B
E
C
D
1
1
C22 R33
R32
D1
D2
C23
R29
IC3
C21
IC4
C24
R30
ST2
2
2
C20
R20
R27
C7
C8
1 IC14
C19
C17
R28
C27
C49
R19
R45 C16
R50
C31 C28 C15
D10
DR1
IC12
3
3
T1
R42 R49
R48
1
2
R1
DR6
DR34
T2
C26
C41
DR15
DR5
DR16 R52
ST1
DR7
DR4 R44
C48
D7
DR2
D8
DR3
1
2
C47
D11
BR2
ST4
2
4
4
DR32
DR33
DR27
DR28
DR25
DR14
DR31
DR30
DR17
DR19
1
C18
C4
DR26
DR24
DR21
DR22
DR23
DR10
1
DR20
DR18
DR29
ST3
DR11
IC5
R24
IC2
SW1
R7 R8
C34
T4
C6
T3
5
5
R10 R11
T6
C12
ÄNDERUNG
T5
R13 R21
T8
C13
IC18
T7
a neue Sachnummer
R22 R23
T10
C14
T9
C45 C43 C46 C42
DATUM
R3 R9
25.02.15
C11 Q1
NAME
C2 C1
R4
BE
GE
C33
C3
R12
6
6
ZD2
IC1
R5
DATUM
R59
LAYOUT
08.03.99
06.10.98
R46
R43
R63
Ott
Sw
1
2
IC11
NAME
FRESENIUS
R16
R17
LP950M
R18
MEDICAL CARE
TD7
IC8
R62
R31
R15
R2DR12
C30 C29
ST5 1
R6
R47
R41
IC13
Q2
C25
7
7
C37
DR13 R36
LP950
ST6 DR8 R14 C9
1 DR9 C5 R53 D3
T11
R58 C32 R34
R37
D4 IC17
C10
R35
T12
Kontroll Platine (HEP)
8
8
M56173
CONTROL BOARD (HEP)
/
A3
BP
BLATT
F
A
B
E
C
D
9.14 PCB LP 950 Control board (HEP)
9.15 PCB LP 644-4 Display board (HEP)

9.16 PCB LP645 Position sensor membrane pump

9.17 PCB LP 649-2 Display board (4008 B/S)
Fig.: Block diagram PCB LP649-2 display board
CS 1 – 12
Bargraph
Duty Art
Ven
Cycle TMP
Conductivity
CS 16, 17
Status LED's
Traffic Light
CS
WR
RD CS 18
A0 Chip-Select Alarm LED
A1 Decoding Key click
A2
A3
A4
CS 20
Key interrupt Keyboard
Encoding
Key matrix (Plug X2)
CS 21
Brightness
Control
CS 22
Alpha
Display
CS 23
UF Goal
UF Time
UF Rate
Data bus D0 – D7 UF Volume


9.18 PCB LP742 Interference filter

9.19 PCB LP748 Display board (BP)

9.20 PCB LP763 Multi interface board (COMMCO III)
X6 FIN X7 BPM X13 BTM X11 KEY

2 2 2 2
1 1 1 1
2 2
X12 CAN X1 zu 729/X1
1 1
IC9
D3
C27
F1 2
BVM X8
C26 C25 1
R13
DR10
F2
DR9
2
UT1
OC1 OC3 zu 729/X4 X10

1
DR5
C24
2 zu 751/X1 X14
IC8 1
R1
R5
2
DR11
DR12
DR4
DR3
DR8
DR7
DR6
C11 C9 X9
1
R4
R3
R2
R6
R8
C13
IC3
R10
C8 C10
R7
T1
C22
T2
C7 C5
IC10
R11
R12
C19
IC2
C20
C4 C6
C21
R9
12 R16
R20
32
22
11
C2
33
IC6
R17
C15
RN3
Q1
R18
C32 C35
R21 IC12
C31
IC1
43
IC13
1
6 2 44 40
2
C33
R24
C34
C3
7 39
43
R25
3 1
C30
3
C2
1
C12
IC5 1
48
R22 X15
75
2
53
IC11
54
64
74
17 29
R19
8
C2
C17
IC4
R23
18 28 C29
off
R15 C18
S1
RN1
Q2
RN4
C16 IC7
DR1
C1
RN2
C
32 1
A
XZ1
g C14 nicht bestückt 18.03.99 Schg

f C14 war Keramik 12.02.98 Schg
e neues LT-D 13.11.97 Ko
j neues LT-G
i neues LT-F
h X2-X5 entfällt 20.12.00 Ko

X4 C12
X3
CI29
IC29 IC1 IC30 IC31 IC32
R40
C11
RN10
LD27
R41
IC20
LD22 LD23 LD24
R33
T16 T14
IC21
LD25
LD26
T13 T15
IC22
T2 T17
D5
CI28
IC33
T9
R29
R30
R32
R31
R28
RN5
RN9
T11
RN3
R55 C5 C7
CI23
RN6 IC24 RN7 IC25 IC26 IC17 R51
R25
C8
X1
R52 C6
T12
CI24
T8
R53 F1
D4
R24
T10 LD18 LD19 R54
R26
R45
CI10
R39
LD17
LD21
T1
RN4
D3
LD20
R42
CI21 R44
IC36
IC10 R43
R15
CI11
XA2
X2
1
R16
48
R21
R20
R17
R18
R19
X5
CI14
Q1
T3
4008 B / 4008 H / 4008 S

T7
RN2
IC11
IC14 IC15 IC16 X6 IC34
RN8
IC12 T6
CI1
C2
XB2
CI13
LD9 LD10 LD11 LD13
R58
R46
R47
R48
R49
R50
CI5 T5 T4 LD12
R61
R22
LD8 R64 R60 R59
C9
48
1
LD14
LD15
LD16
C1
IC2
R7
R8
LS1 CI7
C4
C3
R6
R10 R62 CI8
R4
R63
R11
CI9
CI19
R12
R13
R14
IC9
CI6
D2
LD1 LD2 LD3 LD4 LD5 LD6 LD7
IC7
IC8
RN1
TM-EN
R5
IC3
IC4
IC5
IC6
D7 D9
R34
D10
CI2
T19 T18 D1
R2
C16 D11
CI3 C13 D6 D8
R1 R3
T22
IC13
C15
C14 T21 T20
R57 R56
9.21 PCB LP 922 Display board (4008 S)
12A-2016
g IC19/27 gesockelt
f R44-45 hinzu 05.12.08 Schg
e R40-43 hinzu 09.06.04 SLu
d Option IC34 17.12.03 SLu
i neues LT-K
h neues LT-J
9-29
9.22 PCB LP923 Traffic light (4008 H/S)

9.23 PCB LP 924 Display board (4008 H)

9-32
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9.24 PCB LP 928 CAN bus distributor
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9-33
9.26 Heater board (power supply unit 4008)
E-code of power supply unit < 050:

Heater board and power board must be replaced together.
E-code of power supply unit ≥ 050:

Heater board and power board can be replaced separately.

9.27 Power board (power supply unit 4008)
E-code of power supply unit < 050:

Heater board and power board must be replaced together.
E-code of power supply unit ≥ 050:

Heater board and power board can be replaced separately.


4008 B / 4008 H / 4008 S Hemodialysis Device Technical Manual

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4008 B / 4008 H / 4008 S Hemodialysis Device Technical Manual

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4008 B / 4008 H / 4008 S

1 Important information on the Technical Manual

2 Description of device functions and errors

3 Installation and Technical Safety Checks / maintenance procedures

Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016 iii

iv Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016

9 Circuit diagrams and circuit descriptions

Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016 v

vi Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016

1 Important information on the Technical

1.1 How to use the Technical Manual

Footer The footer contains the following information:

Keyboard shortcut Keys on the device are shown in bold type.

Messages Messages on the device are shown in bold

Changes Changes to the document will be released as new editions or

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

Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016 1-1

1.2 Significance of warnings

1.3 Significance of notes

1.4 Precautions for working on the device

1-2 Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016

Spare parts Use only original spare parts.

Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016 1-3

Manufacturer Fresenius Medical Care AG & Co. KGaA

International Fresenius Medical Care

1-4 Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016

2 Description of device functions and

2.1 Description of the T1 Test

2.1.1 T1 test flow diagram, serial

Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016 2-1

No SAVE ERROR NUMBER TEST OK No SAVE ERROR NUMBER

TEST OK No SAVE ERROR NUMBER TEST OK No SAVE ERROR NUMBER

TEST OK No SAVE ERROR NUMBER TEST OK No SAVE ERROR NUMBER

TEST OK No SAVE ERROR NUMBER TEST OK No SAVE ERROR NUMBER

TEST OK No SAVE ERROR NUMBER TEST OK No SAVE ERROR NUMBER

No SAVE ERROR NUMBER TEST OK No SAVE ERROR NUMBER

TEST Hydraulics without HPU Hydraulics with HPU

No SAVE ERROR NUMBER

TEST OK No SAVE ERROR NUMBER

2-2 Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016

TEST OK No DISPLAY ERROR

Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016 2-3

2.1.2 T1 test flow diagram, parallel

TEST TEST TEST TEST TEST TEST ARTERIAL

TEST VENOUS TEST

SAVE ERROR NUMBER SAVE ERROR NUMBER

TEST TEST TEST

Yes Yes Yes

SAVE ERROR NUMBER SAVE ERROR NUMBER SAVE ERROR NUMBER

TEST No Yes TEST

TEST OK Yes TEST OK Yes

SAVE ERROR NUMBER SAVE ERROR NUMBER

TEST TEST TEST POSITIVE

TEST OK Yes TEST OK Yes TEST OK Yes

SAVE ERROR NUMBER SAVE ERROR NUMBER SAVE ERROR NUMBER

Hydraulics without HPU Hydraulics with HPU

2-4 Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016

T1 TEST FAILED Yes

FURTHER No NEXT INCORRECT TEST STEP

Fresenius Medical Care 4008 B / 4008 H / 4008 S TM-EN 12A-2016 2-5

2.1.3 Description of the T1 Test including errors

 Conditions for starting and running the test

Error message Description