Professional Documents
Culture Documents
Hemodialysis Device
Service Manual
Software version: ≥11.8
Edition: 8A-2013
Part no.: M51 482 1
0123
Table of contents
1 Index
2 Important information
2.1 How to use the Service Manual................................................................................................ 2-1
2.2 Significance of warnings .......................................................................................................... 2-2
2.3 Significance of notes ................................................................................................................ 2-2
2.4 Precautions for working on the device ................................................................................... 2-2
2.5 Warnings .................................................................................................................................... 2-3
2.5.1 Warnings relating to hygiene ....................................................................................................... 2-3
2.5.2 Warnings relating to electricity..................................................................................................... 2-3
2.6 Addresses .................................................................................................................................. 2-4
3 Installation
3.1 Important initial start-up information ...................................................................................... 3-1
3.2 Important information for use in a domestic environment.................................................... 3-2
3.3 Initial start-up report ................................................................................................................. 3-2
3.4 Explanatory notes on the initial start-up report ..................................................................... 3-6
3.5 Transportation of the hemodialysis device .......................................................................... 3-28
4 Specifications
4.1 Dimensions and weight ............................................................................................................ 4-1
4.2 Identification label (marking of the device)............................................................................. 4-2
4.3 Operating environment ............................................................................................................. 4-3
4.4 Electrical safety ......................................................................................................................... 4-3
4.5 Electrical supply ........................................................................................................................ 4-4
4.6 Fuses .......................................................................................................................................... 4-4
4.7 Supply mains ............................................................................................................................. 4-5
4.8 Guidance and manufacturer's declaration on EMC ............................................................... 4-8
4.8.1 Electromagnetic emissions.......................................................................................................... 4-8
4.8.2 Electromagnetic immunity ........................................................................................................... 4-8
4.8.3 Recommended separation distances between portable and mobile RF telecommunication devices
and the device ........................................................................................................................... 4-10
4.9 Operating conditions .............................................................................................................. 4-11
6 TSC / Maintenance
6.1 Important information for TSC / maintenance procedures.................................................... 6-1
6.2 Accessories and supplies ........................................................................................................ 6-2
6.3 TSC / MA test report .................................................................................................................. 6-2
6.4 Explanatory notes on the TSC / MA test report
Explanatory notes on TSC test report ..................................................................................... 6-6
6.5 TSC test report......................................................................................................................... 6-33
7 Error messages
7.1 T1 test ......................................................................................................................................... 7-1
7.1.1 Conditions for starting and running the test................................................................................. 7-1
7.1.2 Bypass test .................................................................................................................................. 7-1
7.1.3 Optical detector test..................................................................................................................... 7-2
7.1.4 Blood system test ........................................................................................................................ 7-3
7.1.5 Venous pressure system test ...................................................................................................... 7-5
7.1.6 Air detector test ........................................................................................................................... 7-6
7.1.7 Display test .................................................................................................................................. 7-8
7.1.8 Arterial pressure system test ....................................................................................................... 7-8
7.1.9 Battery test .................................................................................................................................. 7-8
7.1.10 Blood leak test ............................................................................................................................. 7-9
7.1.11 Temperature test ......................................................................................................................... 7-9
7.1.12 Negative pressure test (negative pressure holding test) ........................................................... 7-10
7.1.13 Positive pressure test (positive pressure holding test) .............................................................. 7-11
7.1.14 UF functional test....................................................................................................................... 7-14
7.1.15 Conductivity test ........................................................................................................................ 7-15
7.1.16 DIASAFE plus test/ HPU test .................................................................................................... 7-16
7.2 Device error during cleaning programs ................................................................................ 7-18
7.2.1 V84 monitoring .......................................................................................................................... 7-18
7.2.2 PSW (pressure switch) monitoring during free rinsing (only devices with CDS) ....................... 7-19
7.2.3 Rinse section test (check of V91, V99, V100) (only devices with CDS) .................................... 7-22
9 Calibration / adjustment
9.1 CALIBRATION ............................................................................................................................ 9-1
9.1.1 Settings without menu display ..................................................................................................... 9-1
9.1.2 CALIBRATION menu structure.................................................................................................... 9-2
9.1.3 Part 1: Calibrating the arterial pressure ....................................................................................... 9-4
9.1.4 Part 2: Calibrating the pressure in the arterial blood pump ......................................................... 9-5
9.1.5 Without menu display: Setting the blood pump stop alarm.......................................................... 9-6
9.1.6 Part 3: Calibrating the venous pressure ...................................................................................... 9-6
9.1.7 Part 4: Calibrating the venous pressure measurement in the level detector ............................... 9-7
9.1.8 Part 5: Calibrating the blood pump rate ....................................................................................... 9-8
9.1.9 Part 5.1: Calibrating the arterial blood pump rate ........................................................................ 9-8
9.1.10 Part 5.2: Calibrating the SN blood pump rate (option)................................................................. 9-9
9.1.11 Without menu display: Calibrating the Single-Needle blood pump (Single-Needle pressure) (option)
9-10
9.1.12 Part 6: Measuring the volume of the UF pump in liters.............................................................. 9-11
9.1.13 Part 7: Calibrating the degassing pressure................................................................................ 9-12
9.1.14 Part 8: Calibrating the 300 flow rate .......................................................................................... 9-12
9.1.15 Without menu display: Setting the current increasing pulse ...................................................... 9-13
9.1.16 Alternative method of setting the current increase (if an oscilloscope is not available)............. 9-13
9.1.17 Part 9: Calibrating the 500 flow rate .......................................................................................... 9-14
9.1.18 Part 10: Calibrating the 800 flow rate ........................................................................................ 9-15
9.1.19 Part 11: Calibrating the dialysate temperature .......................................................................... 9-15
9.1.20 Part 11.1: Setting the dialysate temperature ............................................................................. 9-16
9.1.21 Part 11.2: Checking the dialysate temperature.......................................................................... 9-17
9.1.22 Part 11.3: Checking the dialysate temperature for OCM ........................................................... 9-18
9.1.23 Part 12: Calibrating the mixing system ...................................................................................... 9-19
9.1.24 Part 12.1: Running in the membrane pumps ............................................................................. 9-19
9.1.25 Part 12.2: Determining the balancing chamber volume............................................................. 9-20
9.1.26 Part 12.3: Calibrating the concentrate pump stroke .................................................................. 9-21
9.1.27 Part 12.4: Measuring the volume of the concentrate pump in liters........................................... 9-22
9.1.28 Part 12.5: Calibrating the bicarbonate pump stroke .................................................................. 9-23
9.1.29 Part 12.6: Measuring the volume of the bicarbonate pump in liters........................................... 9-24
9.1.30 Part 12.7: Checking the concentrate and bicarbonate volumes ................................................ 9-25
10 Servicing / repair
10.1 Important information on servicing / repair .......................................................................... 10-1
10.2 Equipment ................................................................................................................................ 10-2
10.3 Component overview .............................................................................................................. 10-3
10.3.1 Monitor....................................................................................................................................... 10-3
10.3.2 Extracorporeal blood circuit module (EBM) ............................................................................... 10-4
10.3.3 Hydraulics rear .......................................................................................................................... 10-6
10.3.4 Hydraulics, left side view ........................................................................................................... 10-7
10.3.5 Hydraulics, right side view ......................................................................................................... 10-8
10.3.6 Hydraulics legend ...................................................................................................................... 10-9
10.3.7 Assignment of the hydraulic processing unit (HPU) ................................................................ 10-10
10.4 Assembly of components..................................................................................................... 10-11
10.4.1 Self-cutting screws .................................................................................................................. 10-11
10.4.2 Torques ................................................................................................................................... 10-11
10.5 Housing and cart ................................................................................................................... 10-12
10.5.1 Tilting the device...................................................................................................................... 10-12
10.5.2 Brake rollers ............................................................................................................................ 10-12
10.5.3 Brakes ..................................................................................................................................... 10-13
11 Functional description
11.1 Functional description ............................................................................................................ 11-1
11.1.1 T1 test description ..................................................................................................................... 11-1
11.1.1.1 T1 test flow diagram, serial run .................................................................................. 11-2
11.1.1.2 T1 test flow diagram, parallel run ............................................................................... 11-3
11.1.1.3 Overview of the individual test sections ..................................................................... 11-4
11.1.1.4 Bypass test................................................................................................................. 11-5
11.1.1.5 Optical detector test ................................................................................................... 11-6
11.1.1.6 Blood system test ....................................................................................................... 11-7
11.1.1.7 Venous pressure system test ..................................................................................... 11-8
11.1.1.8 Air detector test .......................................................................................................... 11-9
11.1.1.9 Display test............................................................................................................... 11-10
11.1.1.10Arterial pressure system test.................................................................................... 11-11
11.1.1.11Battery test ............................................................................................................... 11-12
11.1.1.12Blood leak test.......................................................................................................... 11-13
11.1.1.13Temperature test ...................................................................................................... 11-14
11.1.1.14Negative pressure holding test................................................................................. 11-15
11.1.1.15Positive pressure holding test .................................................................................. 11-16
11.1.1.16UF function test ........................................................................................................ 11-17
11.1.1.17Conductivity test ....................................................................................................... 11-18
11.1.1.18DIASAFE plus test/ HPU test ................................................................................... 11-19
11.1.2 Tests during cleaning programs .............................................................................................. 11-20
11.1.2.1 PSW (pressure switch) monitoring during free rinsing (only devices with CDS) ...... 11-20
11.1.2.2 Rinse section test (check of V91, V99, V100) (only devices with CDS)................... 11-21
11.1.2.3 Rinse section test (check of V91, V99, V100, V130) (only devices without CDS) ... 11-22
11.1.2.4 V39 test .................................................................................................................... 11-23
11.1.3 Description of the modules ...................................................................................................... 11-24
11.1.3.1 Arterial blood pump .................................................................................................. 11-24
11.1.3.2 Single-Needle blood pump (optional) ....................................................................... 11-24
11.1.3.3 Heparin pump........................................................................................................... 11-25
11.1.3.4 Level Detector .......................................................................................................... 11-26
11.1.3.5 Optical detector ........................................................................................................ 11-27
11.1.3.6 Venous pressure measurement ............................................................................... 11-27
11.1.4 Functional description of the hydraulics unit............................................................................ 11-28
11.1.4.1 Hydraulic flow diagram ............................................................................................. 11-28
11.1.4.2 Description of the hydraulics unit ............................................................................. 11-30
12 Appendix
1 Index
The source specifications in the index (e.g., 11-3) refer to the page identification in the footer. In this
example, the index entry can be found in chapter 11 on page 3.
2 Important information
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 TSC, maintenance and repair). 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
Organization of the To facilitate the use of documents from Fresenius Medical Care, the
chapters organization of the chapters has been standardized in all manuals.
There may therefore be chapters within this document without any
content. Chapters without content are identified.
Styles used in the The following text styles may be used in the document:
document
Style Description
Menu names and Menu names and fields are shown in bold
fields on the display type on the display.
Example: Field Delete treatment
parameters
Illustrations The illustrations used in the documents may differ from the original if
this does not have any influence on the function.
Warning
Advises the operator that failure to observe this information can result
in personal injury.
Note
Advises the operator that failure to observe this information can:
– cause damage to the equipment.
– result in a specific function not being executed at all or not being
executed correctly.
Authorized persons
Warning
Start-up procedures, extensions, adjustments, calibrations,
maintenance procedures, modifications or repairs may only be carried
out by the manufacturers or persons authorized by them.
Test equipment and The activities described in the document require the availability of the
accessories necessary technical measuring equipment and accessories.
ESD precautions When repairing the device and when replacing spare parts, observe the
applicable ESD precautions.
To be observed after A T1 test and a check of the electrical safety must be performed after
working on the device working on the device.
The current Operating Instructions must be enclosed with the device.
Additional operator briefing may be required.
To be observed after After a disinfection program has been stopped, or if the device is to be
stopping a disinfection preserved, the hemodialysis device must be disconnected from the
program water supply after a maximum of 3 days.
2.5 Warnings
Warning
Risk of infection
To protect the patient from infections, disinfect the device each time you
repaired or commissioned the device and each time you carried out
TSC or maintenance procedures.
Always run a disinfection after having worked on the device in any way!
Warning
Risk of injury caused by electrical voltage.
Touching live parts will cause an electric shock.
Disconnect the power plug before opening the device. Actuating the
On / Off switch stops operation of the device, but does not
disconnect the device from the supply voltage!
2.6 Addresses
Local service
3 Installation
Precautions for working on Before working on the hemodialysis device, first read the information in
the device the following chapter (see Chapter 2.4 on page 2-2).
For initial start-up only The following information is intended only for the initial start-up. This
information is not applicable for recommissioning devices that have
been removed from service or have temporarily been taken out of
service.
Warning
Start-up procedures, extensions, adjustments, calibrations,
maintenance procedures, modifications or repairs may only be carried
out by the manufacturer or persons authorized by them.
TSC/ MA intervals The TSC/MA procedures on this device are to be performed after 24
months.
Warning
The power supply's protective conductor must comply with the
IEC 60364-7-710 standard. The following checks must also be made by
suitably qualified personnel:
– Check the power supply's protective conductor circuit.
The manufacturer points out that local laws take precedence over the
normative standards mentioned above.
Fixed location The location of the hemodialysis device is "fixed" by its connection to
the distinctive power socket (i.e., it is only ever connected to this
socket). Only one unique power socket may be set up at any one
domestic premises.
Changing the location in a Where medical care is provided in a domestic environment (home
domestic environment dialysis), the location of the hemodialysis device is fixed. If, following
this fixed-location installation, the hemodialysis device needs to be
moved to a different location, then the requirements must be met as
specified in this chapter.
Moving within a domestic (see Transportation of the hemodialysis device on page 3-28)
environment
Remarks:
#FMESIG_1##
Remarks:
#FMESIG_2##
Warning
On completion of these procedures it is imperative to run a disinfection.
Re 1 Preparation
Operating condition: Off
Re 2 Visual inspection
Operating condition: Off
Re 2.1 Labels and identifications are present and legible (see illustrations
below).
1 2 x label "Identification label complete device"
Check device specification:
Serial number
Equipment code
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
25
26 Country-specific labels:
26.1 Additional labels for the People's Republic of China:
1 x label "CCC" (to the right of the "Identification label complete
device" on the outside)
1 x label "China RoHS" (to the right of the "Identification label
complete device" on the outside)
26.1
26.1
26.2
Re 2.2 Mechanical condition permits further safe use. There are no signs of
damage or contamination affecting proper function of the device.
To be checked:
– Tubing and cuff of BPM (option)
Re 2.5 Color coding of the dialyzer couplings and of the shunt cover adapted
to customer specifications (counter-current principle).
– Adapt coding of the dialyzer couplings and of the shunt cover as
required by the customer. Ensure counter-current principle by
correct color coding.
– Document the change in the Medical Device Register.
Condition on delivery:
Dialysate inlet port (right): Dialyzer coupling and shunt interlock = red
Dialysate outlet port (left): Dialyzer coupling and shunt interlock = blue
Note
Risk of tubing constriction
Risk of damage to the connectors
Tie the tubes up such that they are not subject to any kinking,
tension, torsion and squeezing.
Note
DIP switch 6 (array 1) is provided for service purposes / trouble-
shooting only and must be set to position OFF for dialysis mode.
S1 S2 S3 LP1631
!
O
N
1
2
3
4
5
6
7
8
S1 S2 S3 LP1631
!
O
N
1
2
3
4
5
6
7
8
– With Central Delivery System:
PCB LP 1631: Array 2, switch 8 is ON
(switch 7 is then no longer relevant!)
S1 S2 S3 LP1631
!
O
N
1
2
3
4
5
6
7
8
PCB LPCheck of DIP switches PCB LP 632 (CPU 2):
Warning
DIP switch 3 (array 1) allows skipping test runs that are requested by
the device.
If the switch is set such that a test run can be skipped, note that the
operator can bypass the automatic test of the safety systems.
The person requesting such a setting is responsible for this procedure.
S1 S2 LP632
!
O
N
1
2
3
4
5
6
7
8
S1 S2 LP632
!
O
N
1
2
3
4
5
6
7
8
Re 3.4 V91, V99, V100 are functional and tight (test not applicable with
activated CDS or with activated rinse section test).
Operating condition: Off
– (heater rod not active!) Press the Cleaning key. Rinse and reset the
service switch to OFF (down) after having completed the rinse
program.
Re 3.6 Connect the DIASAFE® plus filter and run the Filter change program.
Operating condition: Cleaning / Filter change
– Use the Filter change program item in the cleaning menu and start
the disinfection program requested by the device.
Re 4 Check of hydraulics
Re 4.1 Water inlet pressure (reduced): 1.2 bars (+0.2 bars / –0.3 bars)
Operating condition: Service mode / CALIBRATION
Re 4.4 Relief pressure of balancing chamber at 800 ml/min: 2.2 bars (±0.05
bars)
Operating condition: Service mode / CALIBRATION
CALIBRATE BLD
Key
Conf
Key Key
Adjust BLOOD-LEAK Conf volt. bll. = 5.0 V Esc
DATA STORED
Check zero point. With the dialysate circuit open, the water level must
be approximately 10 cm above the shunt interlock.
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
The accuracy of the pressure gage used must correspond to that of the
UMED or HMED.
The accuracy of the pressure gage used must at least correspond to the
following values:
–1 to 2 bars ±5 mbars
2 to 8 bars ±20 mbars
Re 8.1 Make setup settings in the service program and transfer data to the
hemodialysis device.
Operating condition: Service mode / CALIBRATION
Key
Conf
Note: Set the line 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 (+/-).
Check the upper switching points according to the table below. The
upper switching point depends on the stroke volume.
The lower switching point is fixed (75 mmHg).
Stroke volume 10 15 20 25 30 35 40 45 50
(ml)
Switching 110 130 150 172 195 219 244 270 299
point (mmHg)
± 7 mmHg
or
Basic conditions:
– Measurement of protective earth resistance performed.
– Perform the measurement with the hemodialysis device at operating
temperature.
– Dialysate:
Dialysis temperature: ≥ 36.5 °C
Dialysate flow: ≥ 300 ml/min
Conductivity: ≥ 13 mS/cm
– For direct measurement additionally note:
The device must be insulated when installed.
All external connections must have been removed from the device.
The line voltage during the measurement will be recorded, as well as
the maximum device leakage current, scaled to the nominal voltage of
the power supply. Maximum device leakage current: 500 µA.
Example:
Line voltage during measurement: 225 V
Device leakage current:
mains polarity 1: 180 µA
mains polarity 2: 120 µA
Maximum value of both mains polarities: 180 µA
Nominal voltage of power supply: 230 V
Scaled to nominal voltage 184 µA
(180 µA: 225 V x 230 V = 184 µA
Device leakage current < 500 µA: OK
Additional requirements:
– If the value scaled to the nominal voltage is higher than 90 % of the
admissible alarm limit (= 450 µA), the last measured value or the first
measured value must additionally be applied 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 has not been passed.
Example 1:
Device leakage current: 470 µA
Last measured value: 450 µA
470 + (470 – 450) = 470 + 20 = 490 (-> passed!)
Example 2:
Device leakage current: 470 µA
Last measured value: 390 µA
470 + (470 – 390) = 470 + 80 = 550 (-> not passed!)
Re 11 Functional test
Re 12 Check of conductivity
(Connect the bibag®)
Re 13 Check of temperature
Re 14 Final check
Re 14.1 Power failure alarm – continuous sound – text display: Power Failure
Operating condition: Preparation
Assessment of the test The device has been released for further use
(attach inspection label).
It must be ensured that the intended use of the device will not present
a hazard to patients, operators and other third parties.
Within the scope of the overall assessment, the tester must make a
definite decision whether the device may be used or not. The
responsible organization must immediately be informed of any defects
detected.
Date of next check:
The next check date is entered in the report.
The intervals specified by the manufacturer must be observed.
Remarks:
Any irregularities which occurred during the assessment are
documented in this section.
Date, signature, stamp:
Assessment of the initial start-up has to be confirmed by date, tester's
signature and stamp.
Warning
– Risk of scalding
Before transporting the device, ensure that there are no corrosive or hot
fluids in the device. Programs such as disinfection or hot disinfection
(including cool down rinse) must have completed.
Warning
During transportation – Lift the hemodialysis device over uneven surfaces (e.g.
cobblestones).
– For vehicular transportation, cushion the hemodialysis device
appropriately and keep it upright if possible. If the hemodialysis
device has to be transported on its side, then lower it gently and
transport it with adequate cushioning on all sides.
After transportation – After moving the device, bring the hemodialysis device back into
service (see Recommissioning in the Removal from service set
4008).
4 Specifications
13
12 1
11 2
10
3
9
6 5 4
1 IP protection 21
2: Protection against touch and foreign bodies
with a diameter of at least 12.5 mm
1: Protection against ingress of liquids:
Drip-proof
2 CE mark
3 Identification of electric and electronic devices
4 Degree of protection against electric shock: Type B
5 Relative humidity (Operating conditions)
6 Atmospheric pressure (Operating conditions)
7 Manufacturer with date of manufacture as year digit
8 Operating temperature range
9 Power requirements (voltage / power consumption)
10 Maximum total weight (empty weight + safe working load)
11 Serial number
12 Type identification
13 Equipment code (EC)
4.6 Fuses
Battery 1 x T 3.15 A; power supply unit, fuse in housing foot (rear) / SI5
Warning
When using central venous catheters, the following precautions must
be observed:
1. The hemodialysis device must be connected to the potential
equalization.
2. If additional electro-medical devices are connected to the patient or
they are positioned within close proximity of the patient, it must be
ensured that all leakage currents of those devices (device leakage
currents, housing leakage currents, earth leakage currents and
patient leakage currents) are below the respective limit for CF
applied parts.
This means:
10 µA maximum in normal conditions and 50 µA in "single fault
conditions".
This also applies to patient positioning devices (e.g., patient chairs).
Devices with leakage currents within these limits, but with an
application current exceeding the specified leakage currents (e.g.,
on electro-stimulators) may not be used. This also applies to
defibrillators which have no applied part of the CF type.
If all requirements have been fulfilled, these devices may be
operated on the patient or within the reachable area of the patient,
provided they are, like the hemodialysis device, integrated into the
potential equalization.
If these conditions are not fulfilled, no other electro-medical devices
must be connected to the patient or positioned within the reachable
area of the patient.
In case of doubt, contact the local technician.
Catheters
Housing leakage
currents of all types 10
times higher than ”CF”
Patient is patient leakage current!
electrically
connected to
earth potential via
the blood and the
dialysate.
Voltage dips, short < 5 % UT (> 95 % dip < 5 % UT (> 95 % dip After power supply interruptions, the
interruptions and in UT) for 0.5 cycle in UT) for 0.5 cycle battery of the hemodialysis device takes
voltage variations on 40 % UT (60 % dip in 40 % UT (60 % dip in over the supply without delay.
power supply input UT) for 5 cycles UT) for 5 cycles
lines
IEC 61000-4-11 70 % UT (30 % dip in 70 % UT (30 % dip in
UT) for 25 cycles UT) for 25 cycles
< 5 % UT (>95 % dip < 5 % UT (> 95 % dip
in UT) for 5 seconds in UT) for 5 seconds
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be
(50 / 60 Hz) at levels characteristic of a typical location
magnetic field in a typical commercial or hospital
IEC 61000-4-8 environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
Portable and mobile RF communications
equipment should be used no closer to any
part of the hemodialysis device, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance:
Conducted RF 3 Vrms 3 Vrms d = 1.17 √P
IEC 61000-4-6 150 kHz to 80 MHz for 150 kHz to < 80 MHz
Radiated RF 3 V/m 3 V/m d = 1.17 √P
IEC 61000-4-3 80 MHz to 2.5 GHz for 80 MHz to < 800 MHz
d = 2.34 √P
for 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey, a should be less than the
compliance level in each frequency range
b.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
hemodialysis device is used exceeds the applicable RF compliance level above, the hemodialysis device
should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the hemodialysis device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF telecommunication devices and
the hemodialysis device
The hemodialysis device is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or user of the hemodialysis device can contribute to avoiding electromagnetic errors,
by adhering to the minimum distance between portable and mobile HF telecommunications devices (transmitters)
and the hemodialysis device – dependent on the exit performance of the communication device, as indicated
below.
Rated maximum output Separation distance according to frequency of transmitter m
power of transmitter 150 kHz to < 80 MHz 80 MHz to < 800 MHz 800 MHz to 2.5 GHz
W d = 1.17 √P d = 1.17 √P d = 2.34 √P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.2 1.2 2.3
10 3.7 3.7 7.4
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Water inflow rate 1.3 l/min; with an inlet pressure of 1.5 bars
Water inflow line The length of the water inflow line to a permanent permeate connection
(e.g., MSC 08) must not exceed 3 m.
Water quality Only water suitable for dialysis should be used for operating the
hemodialysis device. The quality of the water should comply with the
local regulations (e.g., ISO 13959:2009).
Maximum permitted values for total viable count and endotoxin
concentration in dialysis water (permeate):
ISO 13959:2009 < 100 (AL* : 50) < 0.25 (AL* : 0.125)
Water drain The height of the water drain outlet must be 0 to 100 cm above ground
level. The drain outlet must be lower than the dialyzer. An air gap of at
least 2 cm must be maintained at the end of the drain. A dedicated,
separate, unused drain outlet must be provided for each hemodialysis
device. Never combine drain outlets from multiple devices before the air
gap is reached. The length of the drain outlet to the air gap must not
exceed 3 m. Observe any specific national provisions on the execution
of drain outlet air gaps/backflow prevention measures.
Operating temperature 15 °C to 35 °C
range
Temporary removal from We recommend carrying out a hot rinse program without a cooling rinse
service (PGM 2) prior to removal from service and a disinfection before
restarting.
Average acid concentrate Dialysis (mixing ratio 1+44 ACF): approx. 0.7 liters
consumption
Antifreeze solution When storing the hemodialysis device with antifreeze, make sure to use
antifreeze of the following composition:
– 49.875 % water
– 49.875 % glycerin
– 0.25% ClearSurf
Maintenance of the built-in If the device is not used the batteries have to be charged every six
rechargeable battery months as follows:
– Connect the device to the external power supply by the power cable.
– Run the device for approximately 10 hours.
If the device is not used, repeat this procedure every six months.
Warning
The operator must not simultaneously touch the patient and contacts of
ports or connectors (e.g., Ethernet port or contacts of the Ethernet data
cable).
Alarm out For the connection of an external alarm indicator (staff call). (Potential-
(alarm output) free alarm output. Alternating contact maximum 24 V / 24 W).
Jack: 5-pin diode plug via a shielded line; shield must be grounded on
both sides.
Audio paused Alarm mute time: Adjustable in the SETUP MENU from 1 minute to
2 minutes
(default: 1 minute)
Any new alarm reactivates the silenced audible alarm.
Plastics
ABS
EPDM X
NBR
PA (PA 6.6)
PBT
PBT X
PBT / ABS GF 20
PC X
PC+ABS
PE
PE (soft)
PEEK X
PES X
Polyester
POM
PP X
PP-H X
PP(E)
PPO X
PPS X
PPSU X
PS
PSU
PTFE X
PUR
PVC
PVDF X
Silicone SIK X
Silicone tubing X
TPE
VMQ SI (Q)
Silicone X
TEEE
CM/ EPDM-L
EPDM
Metals/glass
Graphite X
Glass X
Aluminum
Copper sheet
Steel sheet
Aluminum sheet
St37K
1.4300
1.4301
1.4305
1.4401 X
1.4404 / 1.4435 X
Titanium X
Radox
Lexan (Plexiglas)
Oxit 100
Steel 1.1121
MS 58
MS 63
Leather (bag)
Paper
Silpad 400
Ceramics X
Miscellaneous – adhesives
Loctite
Scotch-Weld DP 460
Scotch-Weld V 23
Cyanolit
Elastosil
3 M Scotch Weld
EPXDPU60
Miscellaneous – coatings
Primer:
P 81.914 (base)
Miscellaneous – packaging
Ethafoam (polystyrene)
Corrugated board
Cellular rubber
Wooden pallet
Electrical equipment
The Service menus CALIBRATION, DIAGNOSTICS, MISCELLANEOUS and SETUP MENU can only
be accessed in Service mode.
Warning
Setting the service switch to ON while the treatment or the cleaning
program is in progress will turn off the heater relay.
CALIBRATION
LM
DIAGNOSTICS
LM
MISCELLANEOUS
LM
SETUP MENU
LM
CALIBRATION, DIAGNOSTICS, MISCELLANEOUS and SETUP MENU are controlled with the following
keys.
Function Key
CALIBRATION
LM
DIAGNOSTICS
LM
MISCELLANEOUS
LM
Key
SETUP MENU Conf
LM
SETUP MENU
Key
Conf
LM LM
Key (see Chapter 5.1.3.3 on Key (see Chapter 5.1.3.15 on
SETUP CLEANING PGM Conf page 5-6) SET KEY-CLICK Conf page 5-22)
LM LM
Key (see Chapter 5.1.3.4 on Key (see Chapter 5.1.3.16 on
SETUP DILUTION Conf page 5-11) BPR/UFR WARNING Conf page 5-22)
LM LM
Key (see Chapter 5.1.3.5 on Key (see Chapter 5.1.3.17 on
SET CONDUCT. LIMIT Conf page 5-15) SET RINSE-VOLUME Conf page 5-23)
LM LM
Key (see Chapter 5.1.3.6 on Key (see Chapter 5.1.3.18 on
INFO SOUND ( C-PGM ) Conf page 5-15) T1-TEST AUTOSTART Conf page 5-23)
LM LM
Key (see Chapter 5.1.3.7 on Key (see Chapter 5.1.3.19 on
SET DIAL PARAMETERS Conf page 5-15) VENOUS LIMITS Conf page 5-23)
LM LM
Key (see Chapter 5.1.3.8 on Key (see Chapter 5.1.3.20 on
CALC.CUMUL.BLOOD-VOL Conf page 5-19) SET CENTRAL-DELIVERY Conf page 5-24)
LM LM
LM LM
optional
Key (see Chapter 5.1.3.10 on Key (see Chapter 5.1.3.22 on
AUTOM. SN-START Conf page 5-20)
SET BPM Conf page 5-25)
LM LM
optional
Key (see Chapter 5.1.3.11 on Key (see Chapter 5.1.3.23 on
ACTIV. MONIT_NTC109 Conf page 5-21) NETWORK Conf page 5-28)
LM LM
LM LM
Key (see Chapter 5.1.3.13 on Key
SET STD. PRIME-TIME BACK TO MAIN MENU ? Conf
Conf page 5-21)
LM LM
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
Key
Conf
Key
Art Al Delay = 5s Esc
Key
Audio paused
DATA STORED
Key
Conf
Key
Ven Al Delay = 5s Esc
Key
Audio paused
DATA STORED
Key
Conf
Key
Flow-Off-T = 30min Esc
Key
Audio paused
DATA STORED
Key
Conf
Key
UF warn time = 10min Esc
Key
Audio paused
DATA STORED
Set MUTE-TIME
Key
Conf
Key
MUTE-Time = 1min Esc
Key
Audio paused
DATA STORED
Key
Conf
LM
Key
DEFAULT Cleaning Pgm see part 2.2
Conf
LM
Key
back to menu ? Conf
LM
Note
When indicating the cleaning times, the default values and the
adjustable range are not indicated, as they depend on the particular
device options.
CLEANING Times
Key
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
LM
Key
back to menu ? Conf
LM
Rinsing TIME
Key
Conf
Key
Rinsing Time = 15min Esc
Key
Audio paused
DATA STORED
Hotrinse TIME
Key
Conf
Key
H-Rinse Time = 15min Esc
Key
Audio paused
DATA STORED
Disinfection TIME
Key
Conf
Key
Disinf. Time = 10min Esc
Key
Audio paused
DATA STORED
Key
Conf
Key
R.-Free Time = 6min Esc
Key
Audio paused
DATA STORED
Hot-Disinf TIME
Key
Conf
Key
H-Disinf Time= 10min Esc
Key
Audio paused
DATA STORED
Key
Conf
Key
M-Rinse Time = 15min Esc
Key
Audio paused
DATA STORED
CITRO-Mandat-Ri-Time
Key
Conf
Key
CITRO-MRTime = 10 min Esc
Key
Audio paused
DATA STORED
INTEGRATED-HR Time
Key
Conf
Key
INT. HR-Time = 15 min Esc
Key
Audio paused
DATA STORED
Key
Conf
Key
After approx.
PGM 1: -R- Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
PGM 2: -R- endless Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
PGM 1: -F-HR-C- Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
PGM 2: -F-HR- Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
PGM 3: -IHR- Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key After approx.
PGM 1: -F-D-M- Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key After approx.
PGM 2: -F-HDIS-M- Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
PGM 3: -F-D-M-HR- Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key After approx.
PGM 4: -F-HDIS-M-HR- Audio DATA STORED 3 seconds
paused
Key
+/– Esc
SETUP DILUTION
Key
Conf
Key
Audio After approx.
canister 1+34 DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
1+35.83 ( NaCl 20 ) Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key After approx.
1+35.83 ( NaCl 26 ) Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
1+35.83 ( Belgium ) Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
canister 1+44 C Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
canister 1+44 ACF Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key see part 3.1
VARIABLE SETTING Conf
Key
+/– Esc
SETUP DILUTION
SETUP DILUTION
Key
Conf
Key Key
After approx.
canister 1+34 Audio ACKNOWLEDGED CDS 1+34 Audio DATA STORED 3 seconds
paused paused
Key
Key Esc
+/– Esc
Key Key
After approx.
1+35.83 ( NaCl 20 ) Audio ACKNOWLEDGED CDS 1+34 Audio DATA STORED 3 seconds
paused paused
Key
Key Esc
+/– Esc
Key Key
Audio After approx.
1+35.83 ( NaCl 26 ) Audio ACKNOWLEDGED CDS 1+34 DATA STORED 3 seconds
paused paused
Key
Esc
Key
+/– Esc
Key Key
After approx.
1+35.83 ( Belgium ) Audio ACKNOWLEDGED CDS 1+34 Audio DATA STORED 3 seconds
paused paused
Key
Esc
Key
+/– Esc
Key Key
After approx.
canister 1+44 C Audio ACKNOWLEDGED CDS 1+34 Audio DATA STORED 3 seconds
paused paused
Key
Key Esc
+/– Esc
Key Key
After approx.
canister 1+44 ACF Audio ACKNOWLEDGED CDS 1+34 Audio DATA STORED 3 seconds
paused paused
Key
Key Esc
+/– Esc
Key
Key see part 3.1 Audio After approx.
VARIABLE SETTING Conf CDS 1+34 DATA STORED 3 seconds
paused
Key
+/– Esc
Key
Esc
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 user adjustable mixing ratio, make sure to use the right
concentrate.
Using a bibag® in combination with the user adjustable mixing ratio is
not allowed.
Only enter approved user adjustable mixing ratios.
SETUP DILUTION
Key
Conf
+/–
Key Key
VARIABLE SETTING Conf B-Comp[part] :0.800 Esc
Key
Audio paused
ACKNOWLEDGED
After approx.
3 seconds
Key
RO[part] :30.000
Esc
Key
Audio paused
ACKNOWLEDGED
After approx.
3 seconds
Key
HCO3-[mmol]:25
Esc
Key
Audio paused
ACKNOWLEDGED
After approx.
3 seconds
Key
Na(B)[mmol]:25 Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
Key
Conf
Key
Cd Limit: 12.8 mS/cm Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
Key
Conf
Key
Conf
LM
Key see part 6.2
SET Flow Parameter Conf
LM
Key see part 6.3
SET Temp. Parameter Conf
LM
Key see part 6.4
SET Na/Bic Parameter Conf
LM
Key
back to menu ? Conf
LM
AdaptedFlow ON/OFF
Key
Conf
Key
Conf
Key
After approx.
Flow[ml/min]:500 Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
Audio After approx.
Flow[ml/min]:800 DATA STORED 3 seconds
paused
Key
+/– Esc
Key After approx.
Flow[ml/min]:300 Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key After approx.
Value set in Dial. Audio DATA STORED 3 seconds
paused
Key
optional
+/– Esc
Key After approx.
AdaptedFlow:F1.2 Audio DATA STORED 3 seconds
paused
Key
optional
+/– Esc
Key After approx.
AdaptedFlow:F1.5 Audio DATA STORED 3 seconds
paused
Key
optional +/– Esc
Key After approx.
AdaptedFlow:Variable Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
Conf
optional
Key
AdpFlow factor:1.9 Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
Key
Conf
Key
Temp.[°C]:36.5 Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
Key
Conf
Key
Base Na+ 135mmol Esc
Key
Audio paused
ACKNOWLEDGED
After approx.
3 seconds
Key
Prescr. Na+ 135mmol Esc
Key
Audio paused
ACKNOWLEDGED
After approx.
3 seconds
Key
Bicarbonate: ±0mmol Esc
Key
Audio paused
ACKNOWLEDGED
After approx.
3 seconds
Key
Limit Na/Base 13mmol Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
CALC.CUMUL.BLOOD-VOL
Key
Conf
Key
After approx.
during seq DIAL: YES Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
during seq DIAL: NO Audio DATA STORED 3 seconds
paused
Key
+/– Esc
OCM SETTINGS
Key
Conf
LM
LM
Key see part 8.3
OCM KT/V WARNLEVEL Conf
LM
Key
back to menu ? Conf
LM
OCM MEASUREMENT
Key
Conf
Key
After approx.
OCM Measurement: OFF Audio DATA STORED 3 seconds
paused
(Default value: Key
OFF) +/– Esc
Key
After approx.
OCM Measurement: ON Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
Conf
Key
Delaytime: 18 s Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
Key
Conf
Key
Kt/V Warnlevel: 85% Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
AUTOM. SN-START
Key
Conf
Key
After approx.
autom. SN: OFF Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
autom. SN: ON Audio DATA STORED 3 seconds
paused
Key
+/– Esc
ACTIV. MONIT_NTC109
Key
Conf
Key
After approx.
MONIT_NTC109: YES Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
MONIT_NTC109: NO Audio DATA STORED 3 seconds
paused
Key
+/– Esc
UF SETTINGS
Key
Conf
Key
After approx.
UF auto start Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
std UF data active Audio DATA STORED 3 seconds
paused
Key
+/– Esc
UF rate: 750 ml/h
UF goal: 3000 ml
UF time left: 4 h
Key
After approx.
normal UF mode Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
Conf
Key
Prime-Time = 2 min Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
SOUND I/O-SWITCH
Key
Conf
Key
After approx.
I/O-Warnsound: ON Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
I/O-Warnsound: OFF Audio DATA STORED 3 seconds
paused
Key
+/– Esc
SET KEY-CLICK
Key
Conf
Key
After approx.
key-click: ON Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
key-click: OFF Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Note
The BPR/UFR warning may be deactivated only for service work or
when troubleshooting. In dialysis mode, the BPR/UFR warning must
always be enabled, i.e., "ON".
BPR/UFR WARNING
Key
Conf
Key
After approx.
BPR/UFR warning: ON Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
After approx.
BPR/UFR warning: OFF Audio DATA STORED 3 seconds
paused
Key
+/– Esc
SET RINSE-VOLUME
Key
Conf
Key
RINSE-VOL: 1000 ml Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
T1-TEST AUTOSTART
Key
Conf
VENOUS LIMITS
Key
Conf
LM
LM
Key
back to menu ? Conf
LM
ASYM. LIMITS
Key
Conf
Key
After approx.
asym. limits: ON Audio DATA STORED 3 seconds
paused
(Default Key
value: ON) +/– Esc
Key
After approx.
asym. limits: OFF Audio DATA STORED 3 seconds
paused
Key
+/– Esc
Key
Conf
Key
After approx.
ven. window pos: OFF Audio DATA STORED 3 seconds
paused
(Default Key
value: OFF) +/– Esc
Key
Audio After approx.
ven. window pos: ON DATA STORED 3 seconds
paused
Key
+/– Esc
SET CENTRAL-DELIVERY
Key
Conf
Key
Conf
SET BPM
Key
Conf
Key (see Part 21.1: Setting the preselected pressure on page 5-25)
Preselected Pressure Conf
LM
Key
Upper SYS limit (see Part 21.2: Setting the upper systolic limit on page 5-26)
Conf
LM
Key
Lower SYS limit Conf
(see Part 21.3: Setting the lower systolic limit on page 5-26)
LM
Key
Upper DIA limit Conf
(see Part 21.4: Setting the upper diastolic limit on page 5-26)
LM
Key
Lower DIA limit Conf
(see Part 21.5: Setting the lower diastolic limit on page 5-27)
LM
Key
Upper MAP limit Conf
(see Part 21.6: Setting the upper MAP limit on page 5-27)
LM
Key
Lower MAP limit Conf
(see Part 21.7: Setting the lower MAP limit on page 5-27)
LM
Key
Upper Pulse limit Conf
(see Part 21.8: Setting the upper pulse limit on page 5-28)
LM
Key
Lower Pulse limit Conf
(see Part 21.9: Setting the lower pulse limit on page 5-28)
LM
Key
back to menu ? Conf
LM
Preselected Pressure
Key
Conf
Key
Audio paused
DATA STORED
After approx.
3 seconds
Key
Conf
Key
Upper SYS = 165mmHg Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
Key
Conf
Key
Lower SYS = 90mmHg Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
Key
Conf
Key
Upper DIA = 100mmHg Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
Key
Conf
Key
Lower DIA = 50mmHg Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
Key
Conf
Key
Upper MAP = 120mmHg Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
Key
Conf
Key
Lower MAP = 70mmHg Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
Key
Conf
Key
Upr. Pulse = 120/min Esc
Key
Audio paused
DATA STORED
After approx.
3 seconds
Key
Conf
Key
Audio paused
DATA STORED
After approx.
3 seconds
NETWORK
Key
Conf
Key
Network settings Conf
(see Part 22.1: Network settings on page 5-29)
LM
Key
Network test Conf
(see Part 22.2: Network test on page 5-30)
LM
Key
back to menu ? Conf
LM
Function Key
Mode setting:
– FIS:
Download and upload possible
(connection to an external system such as
TDMS).
– Client
Only upload possible
(connection to other external systems).
MAC addr. setting:
– Cannot be changed. Value is saved on
PCB LP 1631.
Location setting:
– Setting can be changed only with PC
Service Software 4008.
– STORE DEFAULT VALUES is used to
delete the Location setting.
Network test
Key
Conf
Test is started.
Various messages are displayed.
Key
Esc
Network off Network is turned off in Setup. Configure and turn on network in
Setup.
Database timeout The database is not responding Check server address and
within the time window. database availability.
Database error Cannot reach the database. Check server address and
database availability.
Key
Conf
Key
Press ALARMTONE MUTE Esc
DATA STORED
After approx.
3 seconds
5.1.4 DIAGNOSTICS
CALIBRATION
LM
Key
DIAGNOSTICS Conf
LM
MISCELLANEOUS
LM
SETUP MENU
LM
In DIAGNOSTICS, all inputs and outputs of the hemodialysis device can be activated.
Activation refers to CPU1 (PCB LP 1631), CPU2 (PCB LP 632), as well as to the output board
(CB LP 634) and the input board (PCB LP 633-5).
This program allows technicians to make their own settings for checking error symptoms.
The corresponding levels are indicated on the READ DIGITAL INPUTS menu via the fields to on the
display as well as by the operation status indicators (traffic lights) and the loudspeaker.
The active signal state (may indicate both voltage and no voltage) is indicated by 1111 on the display
(fields to ), by the operation status indicators (traffic lights) and by an audible signal.
The audible signal can be deactivated by pressing the Audio paused key. If the audible signal is
deactivated, the Audio paused key 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 DIAGNOSTICS, 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 wiring diagram
(e.g., PCB LP 633-5: 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.
Based on their assignment to latch groups, signals can be easily found
in the menu by means of the wiring diagram, even if the signal name has
changed. Just one known signal within one latch group is sufficient to
find the renamed signal in the menu by counting.
The voltage values specified can differ because of tolerances in the
particular devices.
DIAGNOSTICS
Key
Conf
LM LM LM
Key
CPU2: RD ANALOG INP. Conf see part 2
LM
Key
LM back to menu ? Conf
LM LM
Key
back to menu ? CPU2: RD DIGITAL INP Conf
see part 4
LM Key LM
Conf
Key
LM back to menu ? Conf
LM LM LM
Key
CPU2: WR ANALOG OUTP Conf see part 6
LM
Key
LM back to menu ? Conf
Key Key
WRITE DIGIT. OUTPUTS Conf CPU1: WR DIGIT. OUTP see part 7
Conf
LM LM
Key
back to menu ? CPU2: WR DIGIT. OUTP Conf
see part 8
LM Key LM
Conf
Key
LM back to menu ? Conf
Key Key
INP/OUTP COMBINATION CPU1: COMBINATION see part 9
Conf Conf
LM LM
Key
LM back to menu ? Conf
Key Key
CAN-COMPONENTS Conf
HPU Conf
see part 10
LM LM
Key
LM back to menu ? Conf
Key
BPM Conf
see part 11
LM
Key
BACK TO MAIN MENU ? Conf
LM
Navigation
Menu display Description
Explanation
Part 1
Key LM Key
CPU1: RD ANALOG INP. I: CPU1_PWR_WD back to menu ?
Conf Conf
LM
I: CPU1_24V_EM 24V_EMERGENCY
24 V, IC 28/28, ADC 117
(22.5-26 V)
I: CPU1_COND_SIGNAL1 CD display
0-10.8 V, IC 28/4, ADC 0-231
back to menu ?
Explanation
Part 2
Key LM Key
CPU2: RD ANALOG INP. I: CPU2_BPR_ART back to menu ?
Conf Conf
LM
I: CPU2_COND_SIGNAL CD display
0-10.8 V, IC 12/8, ADC 0-251
back to menu ?
Explanation
All fields (to ) on the display show 0000, traffic light status indicators
red, yellow, green off:
Low level applied to latch on PCB LP 633-5
All fields (to ) on the display show 1111, operation status indicators
(traffic lights) red, yellow, green on:
High level applied to latch on PCB LP 633-5
If high level is applied, an audible alarm is active at the same time. This
can be suppressed by pressing the Audio paused key. In this case, the
Audio paused LED is lit.
Part 3
Key LM Key
CPU1: RD DIGITAL INP I: CPU1_COND_V84 back to menu ?
Conf Conf
LM
I: CPU1_COND_V84 V 84 CD detection
IC 19/2
Test by pulling off / short-circuiting the sensors
I: CPU1_V43 Valve 43
IC 13/2
Test by opening / closing the valve
I: CPU1_V26 Valve 26
IC 13/3
Test by opening / closing the valve
I: CPU1_V24 Valve 24
IC 13/5
Test by opening / closing the valve
I: CPU1_LC11 IC 13/9
I: CPU1_LA32 IC 15/2
I: CPU1_HEP_ALARM IC 16/8
Trigger heparin pump alarm
(e.g., by blocking the slide carriage)
I: CPU1_HDF_ON HDF on
IC 21/3
Press the HDF On/Off key
I: CPU1_CSS_REED IC 21/6
I: CPU1_HEAT_CLK IC 21/7
I: CPU1_BYP_REQ IC 21/8
I: CPU1_CLP_REQ IC 21/9
back to menu ?
Explanation
All fields (to ) on the display show 0000, operation status indicators
(traffic lights) red, yellow, green off: Low level applied to latch on
PCB LP 632
All fields (to ) on the display show 1111, operation status indicators
(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 Audio paused key. In this case, the
Audio paused LED is lit.
Part 4
Key LM Key
CPU2: RD DIGITAL INP I: CPU2_NC3 back to menu ?
Conf Conf
LM
I: CPU2_V147 IC 7/3
I: CPU2_V145 IC 7/6
I: CPU2_24V_SW 24 V switch
IC 8/7
back to menu ?
Explanation
Display (field ): DAC digits (adjustable by pressing the +/- keys)
Display (field ): Analog voltage on PCB LP 634 in 0.1 V
Part 5
Key Key
CPU1: WR ANALOG OUTP O: CPU1_TEMP_SET LM back to menu ?
Conf Conf
LM
back to menu ?
Explanation
Display (field ): DAC digits (adjustable by pressing the +/- keys)
Display (field ): Analog voltage on PCB LP 632 in 0.1 V
Part 6
Key LM Key
CPU2: WR ANALOG OUTP O: CPU2_TEMP_DET_ADJ back to menu ?
Conf Conf
LM
back to menu ?
Explanation
Part 7
Key LM Key
CPU1: WR DIGIT. OUTP O: CPU1_V24 back to menu ?
Conf Conf
LM
O: CPU1_V24 Valve 24
IC 10/19
O: CPU1_V26 Valve 26
IC 10/18
O: CPU1_V30 Valve 30
IC 7/16
O: CPU1_V31 Valve 31
IC 12/19
O: CPU1_V32 Valve 32
IC 12/18
O: CPU1_V33 Valve 33
IC 12/17
O: CPU1_V34 Valve 34
IC 12/16
O: CPU1_V35 Valve 35
IC 12/15
O: CPU1_V36 Valve 36
IC 12/14
O: CPU1_V37 Valve 37
IC 12/13
O: CPU1_V38 Valve 38
IC 12/12
O: CPU1_V41 Valve 41
IC 7/13
(Valve automatically closes after a short time to prevent water from
overflowing)
O: CPU1_V43 Valve 43
IC 7/15
O: CPU1_V84 Valve 84
IC 7/18
Note: Activation of valve V84 must be followed by Rinse.
O: CPU1_V86 Valve 86
IC 7/17
O: CPU1_V87 Valve 87
IC 10/15
O: CPU1_V91 Valve 91
IC 10/14
Remark: When this menu item is exited (return to "CPU1: WR DIGIT. OUTP."),
the valve is closed.
O: CPU1_V99 Valve 99
IC 7/19
Remark: When this menu item is exited (return to "CPU1: WR DIGIT. OUTP."),
the valve is closed.
O: CPU1_SET_FLOW_ON Flow on
Data word to Gal 23:
0000 0010 (active, V 32 open)
0000 0011 (inactive, V 31, 32 opened)
O: CPU1_BP_FASTER Blood pump rate adjustment (adjustable by pressing the +/- keys)
(RCU 4008)
PCB LP 922/X5.4
back to menu ?
Explanation
Part 8
Key LM Key
CPU2: WR DIGIT. OUTP O: CPU2_WD_RES back to menu ?
Conf Conf
LM
O: CPU2_V24_EN V 24 enable
IC 24/16
Preparation: Activate V 24 (CPU1: WR DIGIT. OUTP)
Test: Switch valve on / off with V 24_EN
O: CPU2_V26 Valve 26
X632/A6
O: CPU2_V43 Valve 43
X632/C5
O: CPU2_NC9 X632/C6
IC 29/13
back to menu ?
Explanation
Display (field ): Feedback / input (in addition, the 3 operation status indicator (traffic light ) LEDs are
lit with 1111)
Display (field ): Activation / output (adjustable by pressing the +/- keys)
Part 9
Key LM Key
CPU1: COMBINATION CPU 1_COMBI: V24 back to menu ?
Conf Conf
LM
back to menu ?
5.1.4.12 HPU
Part 10
HPU
Key
READ ANALOG INPUTS Conf
Key
Conf LM
Key Key
READ INPUTS Conf READ DIGITAL INPUTS Conf
LM LM
Key Key
WRITE OUTPUTS Conf back to menu ? Conf
LM LM
Key
back to menu ? Conf
LM
Key
WRITE ANALOG OUTPUTS Conf not yet implemented
LM
Key
WRITE DIGIT. OUTPUTS Conf
LM O:HPU_AIR_P
Compressor
Key
back to menu ? Conf
185
LM LM
O:WTR_V_TEST
Test valve
V183
LM
O:WTR_V39
Negative pressure
valve V39
LM
O:WTR_RETENT_V
Retentate valve
V189
LM
O:WTR_V_EVAC_INDI
Not implemented
LM
O:WTR_V_EVAC_SOD
Evacuation valve
V188
LM
Key
back to menu ? Conf
LM
Part 11
BPM
Key
Conf
Key Key
Pressure test Conf Start test? Conf Curr. press: XXXmmHg
LM ◄► Key
Esc
Key
Leakage test Conf Start test? Preselected Pressure
LM Key
Conf Use the +/- keys to preselect
Key the pump pressure
back to menu ? Conf (20–300 mmHg)
Curr. press: XXXmmHg
LM Key
Audio paused
The following values will be displayed in four
fields on the monitor
Field 1, after approx. 1 minute:
Starting pressure in mmHg (Tolerance:
+/– 3 mmHg)
Field 2, after approx. 3 minutes:
Final pressure in mmHg (Tolerance:
+/– 3 mmHg)
Field 3:
Leakage in mmHg (Tolerance: +/– 2 mmHg)
Field 4:
Key
Esc
5.1.5 MISCELLANEOUS
CALIBRATION
LM
DIAGNOSTICS
LM
Key
MISCELLANEOUS Conf
LM
SETUP MENU
LM
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 BPM Conf see part 3
LM LM
Key
SYSTEM CLOCK Conf see part 1
LM
Key
BACK TO MAIN MENU ? Conf
LM
Part 1
SYSTEM CLOCK
Key
Conf
Time Date
Key
XX:XX:XX XX:XX:XXXX Esc
Key
Conf
Key
Conf
Key
Audio paused
DATA STORED
After approx.
3 seconds
If a connection to an external system (e.g., TDMS) exists, the SYSTEM CLOCK is synchronized with the
system time configured for the external system (e.g., TDMS).
Part 2
SW-VERSION-NUMBER
Key
Conf
Key
CPU_1-Ver-No.: XX.XX Esc
+/–
Key
CPU_2-Ver-No.: XX.XX Esc
+/–
Key
MDC-Ver-No.: XX.XX Esc
+/–
Key
HPU-Ver-No.: XX.XX Esc
+/–
optional
Key
BPM-Ver-No.: XX.XX Esc
+/–
Key
CPU1 Boot-No.: XX.XX Esc
+/–
Key
LP634 Alarmsys.-No.: X.XX Esc
+/–
Part 3
BPM
Key
Conf
Key Key
Serial number Conf XXXXXXXX Esc
LM
Key Key
Serial number BPU Conf XXXXXXXXXX Esc
LM
Key Key
Operating hours Conf XXXXXXXXX h Esc
LM
Key Key
No. meas. cycles Conf XXXXXXXXXX Esc
LM
Key
back to menu ? Conf
LM
5.1.6 CALIBRATION
For a description of the CALIBRATION service menu, refer to Calibration / adjustment (see
Chapter 9.1 on page 9-1).
Note
DIP switch 6 (array 1) is provided for service purposes / troubleshooting
only and must be set to OFF for dialysis mode.
S1 S2 S3 LP1631
O
N
1
2
3
4
5
6
7
8
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
ON
OFF Not assigned
4
ON
OFF Not assigned
5
ON
OFF Not assigned
6 CRC/RAM test
ON Skip
OFF Go
7 Heater rod
ON 1300 W (at 100 to 127 V)
OFF 1600 W (at 220 to 240 V)
S1 S2 S3 LP1631
O
N
1
2
3
4
5
6
7
8
DIP switch / Function
Position
1 CAL mode
ON Mode 0
OFF Mode 1
4 Remote control
ON Device with remote control
OFF Device without remote control
5
ON
OFF Not assigned
6
ON
OFF Not assigned
S1 S2 S3 LP1631
O
N
1
2
3
4
5
6
7
8
DIP switch / Function
Position
1 2 3 4 5 6 Language setting
8
ON
OFF Not assigned
Warning
DIP switch 3 (array 1) allows skipping test runs that are requested by
the device. If the switch is set such that a test run can be skipped, note
that the operator can bypass the automatic test of the safety systems.
The person requesting such a setting is responsible for this procedure.
S1 S2 LP632
O
N
1
2
3
4
5
6
7
8
1
ON
OFF Not assigned
2 T1 test
ON Serial sequence
OFF Parallel sequence
3 T1 test
ON Skip
OFF Mandatory
4 Test service
ON ON (single test steps can be selected; dialysis mode not possible)
OFF OFF (automatic T1 test)
5 Cyclic PHT
ON Every 2 minutes and result display (Service)
OFF Every 12.5 minutes, alarm output only with cyclic PHT alarm
6 Cyclic PHT
ON ON
OFF OFF
7 Air detector
ON Not permitted
OFF with PCB LP 450-2
8
ON
OFF Not assigned
S1 S2 LP632
O
N
1
2
3
4
5
6
7
8
DIP switch / Function
Position
1 DIASAFE® plus
ON ON
OFF OFF
2
ON
OFF Not assigned
3
ON
OFF Not assigned
4 Hydraulics unit
ON with HPU
OFF Not permitted
5 V39 test
ON OFF
OFF ON
7
ON
OFF Not assigned
8
ON
OFF Not assigned
S1 LP634
O
N
1
2
3
4
DIP switch / Function
Position
Software ≥ 11.4 Software < 11.4
1 2 3 4
OFF OFF OFF OFF Selection field for the Not permitted Not permitted
alarm system on the
Treatment mode*
menu.
ON OFF OFF OFF Alarm system Acute Not permitted Not permitted
OFF ON OFF OFF Alarm system Standard Alarm system Standard Alarm system Standard
If an alarm system is set for which the staff has not been trained yet, instruction must be given prior to
the first treatment.
* On the Treatment mode menu, you can select between the Acute alarm system (default setting) or
the Standard alarm system.
Preparation Switch the device off, dismount the monitor rear, pull out the monitor.
Updating the software For CPU 2, the update is still performed by replacing the EPROM.
With software version 11.00 or higher, the update of CPU 1 and MDC-
II (monitor board) is performed using an SD card:
1. PCB LP 1631 (CPU 1): Array 3, set DIP switch 7 to ON.
2. PCB LP 1631: Insert SD card.
3. Turn the device on.
4. The update is performed automatically.
PCB LP 1631: While CPU 1 is updating, LED D1 flashes. As soon as
the update of CPU 1 is complete, D1 lights. Then D3 flashes until the
update of the MDC-II board is complete. As soon as the update is
complete, D3 lights.
The flash frequency of LEDs D1 and D3 is about 2 Hz (in case of
error about 6 Hz). In the event of an error, LEDs D4 to D8 are used
to evaluate the error (see Error code table on page 5-74).
5. Turn the device off.
6. Reset DIP switch 7 to OFF.
7. The SD card can be removed or remain inserted.
X X 3 Subfolder not present or more than one valid update file present
/
Check update files on SD card.
Quick Guide – The Quick Guide is located on the CD for the PC Service Software
PC service software 4008 4008. The Service Software is installed on a PC (e.g., the technician's
laptop). You also have the option – when performing a new installation
for example – to access the Quick Guide directly from the CD without
installing the Service Software.
Accessing the Quick Guide Three options for accessing the Quick Guide are described below.
1. Precondition: PC Service Software 4008 is installed.
With the Service Software 4008 application open, choose "Help"
from the menu bar to access the Quick Guide as follows:
→ "Help" → "Help Topics" (1)
or:
→ "Help" → "Context Help" (2) (see illustration below)
1
2
3. Insert the Service Software CD into the PC drive (e.g., laptop). You
do not need to run the installation manually, and you can cancel it.
In Windows Explorer, you can access the "Documentation" folder
directly from the folder on the corresponding drive (3). The
"Documentation" folder contains the German and the English
versions of the Quick Guide in PDF format (4) (see illustration
below).
6 TSC / Maintenance
Precautions for working on Before working on the hemodialysis device, first read the information in
the device the following chapter (see Chapter 2.4 on page 2-2).
Warning
When the device is returned to use, check that the pressure of the water
supply meets the prescribed minimum pressure.
Checks This chapter sets out the technical safety checks (TSCs) and the
maintenance procedures (MA) to be performed.
Technical safety checks (TSCs) must be carried out every 2 years
(24 months).
Performance of the TSCs must be recorded in the Medical Device
Register.
The maintenance procedures are a recommendation of the
manufacturer. The maintenance procedures have to be carried out after
2 years (24 months) at the latest and serve to prevent malfunctions.
The explanatory notes on the TSC / MA test report
are applicable to the TSC / MA test report and the TSC test report.
Warning
Start-up procedures, extensions, adjustments, calibrations,
maintenance procedures, modifications or repairs may only be carried
out by the manufacturers or persons authorized by them.
The following articles are required for carrying out the TSC / MA.
Unisilkon grease, L 250 L, (10g tube) Use only in places specified in the
explanatory notes.
Solenoid valve adapter fitting, one port V84 Replace every 2 years, only if
Puristeril 340, Puristeril plus are used.
Remarks:
#FMESIG_3##
Remarks:
#FMESIG_4##
Warning
On completion of these procedures it is imperative to run a disinfection.
Re 1 Visual inspections
Operating condition: Off
Re 1.1 The battery fuse accessible from the outside (see illustration below) (1)
corresponds to the specified rating.
Alternative to checking the fuse: If the seal is undamaged, the battery
fuse does not have to be checked.
Re 1.2 Labels and identifications are present and legible (see illustrations
below).
1 2 x label "Identification label complete device"
Check device specification:
Serial number
Equipment code
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
25
26 Country-specific labels:
26.1 Additional labels for the People's Republic of China:
1 x label "CCC" (to the right of the "Identification label complete
device" on the outside)
1 x label "China RoHS" (to the right of the "Identification label
complete device" on the outside)
26.1
26.1
26.2
Re 1.3 Mechanical condition permits further safe use. There are no signs of
damage or contamination affecting proper function of the device.
To be checked:
– Tubing and cuff of BPM (option)
Re 1.4 Rotor(s) cleaned. Rotor(s) on the line roller pump(s) show no signs of
damage and are fully functional. Color coding of rotor(s) checked.
4 2
3
3
Re 2 Preventive measures
Operating condition: Off
Re 2.1 Replace the sealing plunger in the concentrate and in the bicarbonate
suction tube and grease it with silicone compound. Replace the rivets of
the suction tubes if necessary.
Re 2.2 Check the detent rubber seal of the rinse chambers for proper
functioning.
1
2
Re 2.8 Check the sampling valve (V116) in the dialysate circuit tubing for
proper function and replace the complete valve if necessary.
– Battery (2)
Re 3 General checks
S1 S2 S3 LP1631
O
N
1
2
3
4
5
6
7
8
– Without Central Delivery System:
PCB LP 1631: Array 2, switch 7 is ON
S1 S2 S3 LP1631
!
O
N
1
2
3
4
5
6
7
8
– With Central Delivery System:
PCB LP1631: Array 2, switch 8 is ON
(switch 7 is then no longer relevant!)
S1 S2 S3 LP1631
!
O
N
1
2
3
4
5
6
7
8
Check of DIP switches PCB LP 632 (CPU 2):
– PCB LP 632: Array 1, switch 3 is OFF
S1 S2 LP632
!
O
N
1
2
3
4
5
6
7
8
S1 S2 LP632
!
O
N
1
2
3
4
5
6
7
8
Re 4 DIASAFE® plus
Re 4.2 Replace hydrophobic filter (F111) and hydrophobic filter / test valve
(F184).
Operating condition: Off
Re 5 bibag®
Re 6 OCM
Re 7 Check of hydraulics
All pressures must be checked with undamped pressure gages!
Re 7.2 Check the loading pressure of the balancing chamber and correct it if
required.
Operating condition: Service mode / CALIBRATION
Connect a pressure gage to the pressure side of the degassing pump
(measuring point B in HU). The pressure must be 1.45 bars ±0.05 bars.
Re 7.4 Check balancing chamber relief pressure at a flow of 800 ml/min (relief
valve A78).
Operating condition: Service mode / CALIBRATION
Connect a pressure gage to the pressure side of the flow pump
(measuring point C in HU). Relief pressure: 2.2 ±0.05 bars.
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
measuring cylinder
– Use a measuring cylinder with a maximum tolerance of ±0.5%.
Key
Conf
Key Key
UF pump 1 Conf pulse amount = 60 Esc
ACKNOWLEDGED
Key
press UF key Esc
Key
UF I/O UF pulses left = 60
Note: The remaining UF strokes are
Check the volume. Adjust indicated on the display.
the UF pump if necessary Display field indicates the
and repeat the procedure. number of preselected strokes.
Re 8.2 Measure the volume of the concentrate pump in liters or compare with
an appropriate reference device. If necessary, make settings according
to calibration instructions.
Operating condition: Service mode / CALIBRATION
Re 8.3 Measure the volume of the bicarbonate pump in liters or compare with
an appropriate reference device.
If necessary, make settings according to calibration instructions.
Operating condition: Service mode / CALIBRATION
Re 9 Extracorporeal components
CALIB. (B)-PUMP-RATE
Key
Conf
LM
Key
CALIB. SN. BP-RATE see part 5.2
Conf
LM
Key
back to menu ? Conf
LM
Key
Conf
Note: Set the line 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 (+/-).
Check the upper switching points according to the table below. The
upper switching point depends on the stroke volume.
The lower switching point is fixed (75 mmHg).
Stroke volume 10 15 20 25 30 35 40 45 50
(ml)
Switching point 110 130 150 172 195 219 244 270 299
(mmHg) ±7 mmHg
Re 10 Dialysis mode
DIALYSATE Pressure
Key
Conf
Key
adj.zero.: + XXX mmHg Esc
Switch on flow
Switch on flow
Repeat the
procedure until 0 and Enter the value indicated by the
–500 mmHg match external reference instrument by
Not
the external pressing the +/- keys.
OK
reference instrument.
Key
Audio paused
Key
Audio paused
DATA STORED
Re 11 BPM (option)
Re 11.1 Check that the tube connector is correctly attached to the device.
Operating condition: Off
Re 11.2 Check the attachment of the internal blood pressure module, the printed
circuit boards and all cable connections.
Operating condition: Off
or
Direct measurement according to figure 4:
Basic conditions:
– Measurement of protective earth resistance performed.
– Perform the measurement in Dialysis or Preparation mode with the
device at operating temperature.
– Dialysate:
Dialysis temperature: ≥ 36.5 °C
Dialysate flow: ≥ 300 ml/min
Conductivity: ≥ 13 mS/cm
– For direct measurement additionally note:
The device must be insulated when installed.
All external connections must have been removed from the device.
The line voltage during the measurement is recorded, as well as the
maximum device leakage current of both mains polarities, scaled to the
nominal voltage of the power supply. Maximum device leakage current:
500 µA
Example:
Line voltage during measurement: 225 V
Device leakage current:
mains polarity 1: 180 µA
mains polarity 2: 120 µA
Maximum value of both mains polarities: 180 µA
Nominal voltage of power supply: 230 V
Scaled to nominal voltage 184 µA
(180 µA: 225 V x 230 V = 184 µA
Device leakage current < 500 µA: OK
Additional requirements:
1) If the value scaled to the nominal voltage is higher than 90 % of the
admissible limit (= 450 µA), the last or first measured value must
additionally be applied for the rating.
2) If the device leakage current has considerably increased since the
last or first measurement (gradual deterioration of the insulation), or if
the sum of the current value plus the difference since the last
measurement is > 500 µA, the measurement has not been passed.
Example 1:
Device leakage current: 470 µA
Last measured value: 450 µA
470 + (470 – 450) = 470 + 20 = 490 (-> passed!)
Example 2:
Device leakage current: 470 µA
Last measured value: 390 µA
470 + (470 – 390) = 470 + 80 = 550 (-> not passed!)
Re 13 Functional test
Assessment of the test The device has been released for further use
(attach inspection label).
It must be ensured that the intended use of the device will not present
a hazard to patients, operators and other third parties.
Within the scope of the overall assessment, the tester must make a
definite decision whether the device may be used or not. The
responsible organization must immediately be informed of any defects
detected.
Date of next check:
The next check date is entered in the report.
The intervals specified by the manufacturer must be observed.
Remarks:
Any irregularities which occurred during the assessment are
documented in this section.
Date, signature, stamp
Assessment of the check must be confirmed with the date, the signature
of the person performing the check and a stamp.
TSC report numbering Numbers not listed here are not included in the TSC. They are part of
the maintenance procedures.
Remarks:
#FMESIG_5##
Remarks:
#FMESIG_6##
Warning
On completion of these procedures it is imperative to run a disinfection.
7 Error messages
7.1 T1 test
Dialines not conn The dialysate lines are not in the shunt interlock.
Connect Conc.Line The concentrate connector is in the rinse chamber, or concentrate is not
Wrong conc. supply connected at all. The error message depends on the Central Delivery System
preselected in the SETUP MENU.
Flow alarm Dialysate inlet or dialysate outlet tube kinked, malfunctions in the hydraulics.
F04 Bypass The extended bypass cannot be correctly switched by CPU2 (V24 = off,
V26 = on, V24B = off).
– Feedback (V24, X637/C1) X632/A4 not 24 V
– Feedback (V26, X637/C2) X632/A6 not 0 V
– Feedback (V24B, X637/C23) X632/A5 not 24 V
F05 Bypass The extended bypass cannot be correctly switched off by CPU2 (V24 = on,
V26 = off, V24B = on).
– Feedback (V24, X637/C1) X632/A4 not 0 V
– Feedback (V26, X637/C2) X632/A6 not 24 V
– Feedback (V24B, X637/C23) X632/A5 not 0 V
F06 Bypass CPU1 cannot set the temperature control to hot rinse.
– Control line (HOTRINSE, X634R/C24) X639/A20 not 12 V
– Feedback (HOTRINSE, X634R/C24) X632/A26 not 12 V
F07 Bypass The extended bypass cannot be correctly switched by CPU1 (V24 = off,
V26 = on, V24B = off).
– Feedback (V24, X637/C1) X632/A4 not 24 V
– Feedback (V26, X637/C2) X632/A6 not 0 V
– Feedback (V24B, X637/C23) X632/A5 not 24 V
F09 Bypass The extended bypass cannot be correctly switched off by CPU1 (V24 = on,
V26 = off, V24B = on).
– Feedback (V24, X637/C1) X632/A4 not 0 V
– Feedback (V26, X637/C2) X632/A6 not 24 V
– Feedback (V24B, X637/C23) X632/A5 not 0 V
F01 opt. Detector CPU1 and CPU2 interpret the optical detector differently
– Feedback (OD_OUT, X633L/C7) X632/A30 and digital input on
PCB LP 633-5 measure different levels
F04 opt. Detector CPU2 detects optical detector dark (required because of test in cleaning
program).
– Feedback X632/A30 not 12 V.
– AD28 defective
F09 Blood System Feedback that CPU2 detects arterial blood pump inactive (blood pump not
running).
– Feedback (BPSB_ART, X348a/6) X632/A11 not 12 V.
– Control line (BPSST_ART, X634L/B14) X348a/1 not 12 V or (BPST_ART,
X634L/A14) X348a/3 not 12 V
F10 Blood System Feedback that CPU1 detects arterial blood pump inactive (blood pump not
running).
– Feedback (BPSB_ART, X348a/6) X633/A11 not 12 V
– Control line (BPSST_ART, X634L/B14) X348a/1 not 12 V or (BPST_ART,
X634L/A14) X348a/3 not 12 V
– Level is raised during the T1 test
F11 Blood System The arterial blood pump cannot be stopped by CPU1.
CPU2 detects that the arterial blood pump remains active.
– Control line (BPSST_ART, X634L/B14) X348a/1 not 0 V and (BPST_ART,
X634L/A14) X348a/3 not 0 V
– Feedback (BPSB_ART, X348a/6) X632/A11 not 0 V.
– The level is raised during the T1 test, or the up/down key on the air detector
is blocked and the level is constantly raised.
F12 Blood System The arterial blood pump cannot be stopped by CPU1.
CPU1 detects that the arterial blood pump remains active.
– Control line (BPSST_A, X634L/B14) X348a/1 not 0 V and (BPST_ART,
X634L/A14) X348a/3 not 0 V
– Feedback (BPSB_ART, X348a/6) X633/A11 not 0 V
F19 Blood System Check of BPUS signal (CPU1 PCB LP 1631 via PCB LP 633-5)
At the beginning of the test step a maximum of 40 seconds is waited until
rotation has stopped. If the blood pump is being activated, the rotation stop
alarm must have been cleared.
– Feedback line (BPUS, X348A/8) X633L/ A12 not 0 V
– Feedback line (BPUS, X348A/8) X633L/ A12 not 12 V
F20 Blood System Check of the actual arterial blood pump rate.
The actual rate of the arterial blood pump is not zero. The actual rate of the
arterial blood pump does not increase.
If SN is installed: The actual rate of the venous blood pump is not zero. The
actual rate of the venous blood pump does not increase.
– Feedback line (BPR_ART, X348A/10) X633L/B3 not 0 V or feedback line
(BPR_ART, X348A/10) X632/A14 not 0 V
– Feedback line (BPR_ART, X348A/10) X633L/B3 no increase or feedback
line (BPR_ART, X348A/10) X632/A14 no increase
If SN is installed:
– Feedback line (BPR_VHDF, X348V/10) X633L/B4 not 0 V
– Feedback line (BPR_VHDF, X348V/10) X633L/B4 no increase
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 vent valve in AD defective
– Feedback (P_VEN, X351/4) X633L/B5 that voltage value is outside zero
point tolerance
– P-venous not calibrated
F02 Venous CPU2 shows a venous zero point deviation of more than ±12 mmHg
(60 seconds).
– Control (VENT_VALVE, X634R/C18) X351/1 of vent valve in AD defective
– Feedback (P_VEN, X351/4) X632L/C17 that voltage value is outside zero
point tolerance
– P-venous not calibrated
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
– Feedback (P_VEN, X351/4) X633L/B5, voltage change inadequate
– P-venous not calibrated
F04 Venous The deviation in the measured value between CPU1 and CPU2 is more than
±12 mmHg (if Pven > 100 mmHg).
– Feedback (P_VEN, X351/4) X633L/B5 and X632/C17 measure different
voltage values
– P-venous not calibrated
F01 Level Detector CPU1 and CPU2 interpret air detector signal differently.
– Feedback (LDA1, X351/14) X632/C13 and X633L/C10 detect different
signal levels
F02 Level Detector The air detector alarm is not detected by CPU2.
– Feedback (LDA1, X351/14) X632/C13 not 0 V
– Transmission weakening (LDSA, X632/C16) X351/10 not 12 V
F03 Level Detector Air detector clamps feedback (CPU2) activated (venous line clamp closed).
– Feedback (LDA2, X351/6) X632/C14 not 24 V
– Clamp control (CLP_CTL, X634/C14) X351/8 not 12 V.
– Clamp control (CLP_CTL, X632/C10) X351/8 not 12 V
F04 Level Detector Air detector clamps feedback (CPU1) activated (venous line clamp closed).
– Feedback (LDA2, X351/6) X633L/C13 not 24 V
– Clamp control (CLP_CTL, X634/C14) X351/8 not 12 V.
– Clamp control (CLP_CTL, X632/C10) X351/8 not 12 V
F05 Level Detector The blood alarm signal has not been cleared (indicates an alarm).
– Feedback (BL_AL, X634L/C15) X632/C21 not 12 V
F06 Level Detector Air detector clamp could not be closed via the CPU2 control line.
– Clamp control (CLP_CTL, X632/C10) X351/8 not 0 V
– Feedback (LDA2, X351/6) X632/C14 not 0 V
F07 Level Detector Air detector clamp could not be opened via the CPU2 control line.
– Clamp control (CLP_CTL, X632/C10) X351/8 not 12 V
– Feedback (LDA2, X351/6) X632/C14 not 24 V
F08 Level Detector Air detector clamp could not be closed via the CPU1 control line, or CPU2
feedback incorrect.
– Clamp control (CLP_CTL, X634/C14) X351/8 not 0 V.
– Feedback (LDA2, X351/6) X632/C14 not 0 V
F09 Level Detector Air detector clamp could not be closed via the CPU1 control line, or CPU1
feedback incorrect.
– Clamp control (CLP_CTL, X634/C14) X351/8 not 0 V.
– Feedback (LDA2, X351/6) X633L/C13 not 0 V
F11 Level Detector Air detector clamps feedback (CPU2) activated (venous line clamp closed).
– Feedback (LDA2, X351/6) X632/C14 not 24 V
– Clamp control (CLP_CTL, X634/C14) X351/8 not 12 V.
– Clamp control (CLP_CTL, X632/C10) X351/8 not 12 V
F12 Level Detector Air detector clamps feedback (CPU1) activated (venous line clamp closed).
– Feedback (LDA2, X351/6) X633L/C13 not 24 V
– Clamp control (CLP_CTL, X634/C14) X351/8 not 12 V.
– Clamp control (CLP_CTL, X632/C10) X351/8 not 12 V
F13 Level Detector The blood alarm signal has not been cleared (indicates an alarm).
– Feedback (BL_AL, X634L/C15) X632/C21 not 12 V
F14 Level Detector Raise level key on the air detector constantly active.
– Feedback (LEVEL_UP, X351/3) X632/C11 not 0 V
F15 Level Detector Feedback of supply voltage for ultrasonic output stage after 3 seconds not
between 6.5 and 13.5 V.
– Adapter board AD28 not connected
– Feedback (X351/11 X633L/25A jumper to X633L/B7) not 12 V
– Relay on AD28 failed to drop.
F16 Level Detector Feedback of supply voltage for ultrasonic output stage after 3 seconds not >
14.5 V.
– Adapter board AD28 not connected
– Feedback (X351/11 X633L/ 25A jumper to X633L/B7) no voltage 16 V /
24 V
– Relay on AD28 not tripped
– No 10 Hz signal at ALARM_REST (X351/12)
F17 Level Detector Feedback of supply voltage for ultrasonic output stage after 3 seconds not
between 6.5–13.5 V.
– Adapter board AD28 not connected
– Feedback (X351/11 X633L/25A jumper to X633L/ B7) not 12 V
– Relay on AD28 failed to drop.
F01 Display CPU1 failed to start the display test within 5 seconds.
– No “Test started” information via serial interface
F02 Display CPU1 failed to complete the display test within 120 seconds.
– No “Test passed” information via serial interface
F01 Arterial With detuning in negative direction, the change achieved on the arterial display
is less than 100 mmHg (2 seconds).
– Feedback (P_ART, X348A/7) X633L/B12, voltage change insufficient
– 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).
– Feedback (P_ART, X348A/7) X633L/B12, voltage change insufficient
– Test detuning defective (PA_DET, X632/A17) X348A/9
F01 Battery CPU1 failed to complete the battery test within 5 seconds.
– No “Test passed” information via serial interface
F02 Battery The battery charge is insufficient to emit an audible alarm for 1 min (maybe no
battery connected).
– Battery voltage (U_ACCU, ...) X633L/B21 dropped below 17.6 V.
– Feedback (U_ACCU, ...) X633L/B21 of battery voltage defective.
F01 Blood Leak Blood leak channel and dimness not in alarm-free condition during the T1 test.
– Dimness channel contaminated (calcium precipitate, etc.)
– Feedback (BLL, X637/A18) X633L/B10 voltage value in alarm range
(< 3 V / ≥ 8 V)
– Feedback (BLL_DIM, X637A/21) X633L/B11 voltage value in alarm range
(< 1.5 V / ≥ 8 V)
– DAC_BLL or DAC_DIM not in range (check calibration)
F02 Blood Leak Blood leak alarm / dimness alarm not detected in case of test detuning.
– Feedback (BLL, X637/A18) X633L/B10 voltage value not in alarm range
(≥ 3 V)
– Feedback (BLL_DIM, X637A/21) X633L/B11 voltage value not in alarm
range (≥ 1.5 V)
– Test detuning (BLL_DET, X632/A25) X633L/B27 not 5 V
– DAC_BLL or DAC_DIM calibrated too high
– Detuning (DAC_DIM, X634R/A11) X633L/C3 impossible
– 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.)
– Feedback (BLL, X637/A18) X633L/B10 voltage value in alarm range (<3 V
/ ≥8 V)
– Test detuning (BLL_DET, X632/A25) X633L/B27 not 0 V
– Feedback (BLL_DIM, X637A/21) X633L/B11 voltage value in alarm range
(< 1.5 V / ≥ 8 V)
– DAC_BLL or DAC_DIM not in range (check calibration)
F02 Temperature The actual temperature is less than 35.0 °C (test running time > 15 minutes).
– Calibrate the temperature
– The heater rod has failed
– Feedback (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
– Feedback (T_DIAL1, X633L/B16) X632/A24, voltage stuck
F05 Temperature Detuning in positive direction not more than 3 °C (10 seconds).
– Feedback (T_DIAL1, X633L/B16) X632/A24 voltage change insufficient.
– Detuning (T_DETADJ, X632/A23) X633R/C21 insufficient
F08 Temperature CPU1 failed to transmit a bibag® status message within 3 seconds.
– Runtime problem (software).
F10 Temperature bibag® temperature display out of measuring range (15 to 45 °C)
– Feedback (NTC_BIB, X633R/C15) ADW on PCB LP 633-5
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
– The UF pump is defective
F03 neg. Pressure The working point (116 digits) of the differential amplifier cannot be set correctly
(max. test running time 120 seconds).
– Pressure variations are too large
– The DA converter (IC11) on PCB LP 632 is defective
– The operational amplifier (IC1/IC3) on PCB LP 632 is defective
– Feedback (P_DIAL, X633L/B6) X632/A29 defective
– No CI signal (PCB LP 632 X632/B22).
F04 neg. Pressure Pressure measurement could not be completed (max. test running time
120 seconds).
– The D-A converter (IC11) on PCB LP 632 is defective
– The operational amplifier (IC1/IC3) on PCB LP 632 is defective
– Feedback (P_DIAL, X633L/B6) X632/A29 defective
F05 neg. Pressure The air separation pump started running during the measurement phase.
– Feedback (ACKN_ASP, X634L/B10) X632/A19 not 0 V
– ASP electrically interrupted
F06 neg. Pressure Negative pressure holding test failed. The dialysate pressure drop exceeds
±40 mmHg (referred to 10 balancing chamber switching cycles).
– Leakage in the hydraulic system
F01 pos. Pressure The mandatory filling program of CPU1 has not been completed (10 seconds).
– The solenoid valve V43 is not closed
F25 pos. Pressure No pressure increase above 150 mmHg (change in pressure) after valve
switching.
– Activation signals of V24 and V24B confused
– Leakage in the external system (shunt interlock, dialysate lines, etc.)
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 (open mechanically)
– 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 for 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 out of –125 to 55 mmHg range.
The balancing chamber is switched to passage for this test sequence. V24,
V24B and V26 are closed; V43 is open.
F04 pos. Pressure The first working point (220 digits) of the differential amplifier cannot be set.
– Pressure variations are too large
– The D-A converter (IC11) on PCB LP 632 is defective
– The operational amplifier (IC1/IC3) on PCB LP 632 is defective
– Feedback (P_DIAL, X633L/B6) X632/A29 defective
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 LP 632 is defective
– Feedback (P_DIAL, X633L/B6) X632/A29, voltage change too large
– Detuning defective (P_DETADJ, X632/C20) X633R/C22
– The balancing chamber valve V36 or V38 (drain valve) is leaking
F06 pos. Pressure Test detuning results in a change in the measuring range of less than 85 mmHg
(60 seconds).
– The D-A converter (IC11) on PCB LP 632 is defective
– Feedback (P_DIAL, X633L/B6) X632/A29, voltage change insufficient
– Detuning defective (P_DETADJ, X632/C20) X633R/C22
– V26 leaking
F07 pos. Pressure After detuning in the test 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
– The balancing chamber valve V36 or V38 (drain valve) is leaking
F08 pos. Pressure Test detuning results in a change in the measuring range of more than
400 mmHg (20 seconds).
– The operational amplifier (IC2) on PCB LP 632 is defective
– Feedback (P_DIAL, X633L/B6) X632/A29, voltage change too large
– Detuning defective (P_DETADJ, X632/C20) X633R/C22
F09 pos. Pressure Test detuning results in a change in the measuring range of less than
350 mmHg (20 seconds).
– The D-A converter (IC11) on PCB LP 632 is defective
– Feedback (P_DIAL, X633L/B6) X632/A29, voltage change 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.
– The D-A converter (IC11) on PCB LP 632 is defective
– The operational amplifier (IC1/IC3) on PCB LP 632 is defective
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
– The balancing chamber valve V36 or V38 (drain valve) is leaking
The balancing chamber is switched to passage for this test sequence. V43,
V24B and V26 are closed; V24 is open.
F12 Positive pressure The loading pressure cannot be measured via solenoid valves V24 and V24B in
the hydraulic system (P-Dial. < 600 mmHg, 15 seconds).
– Solenoid valve V24 or V24B mechanically not open
The balancing chamber is switched to passage for this test sequence. V43 and
V26 are closed; V24 and V24B are open.
F13 pos. Pressure The hydraulic system cannot be bled via solenoid valve V43; (P-Dial. not equal
to –125 to 55 mmHg, 20 seconds).
– Solenoid valve V24 is not closed
– V43 not opening electrically or mechanically
The balancing chamber is switched to passage for this test 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).
Default: P-Dial. not equal to –125 to 55 mmHg.
The balancing chamber is switched to passage for this test sequence. V24, V26
and V43 are closed; V24B is open.
F15 pos. Pressure The loading pressure is below 780 mmHg ± 30mmHg (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 does not occlude
– Relief valve A78 or V43 leaking
F17 pos. Pressure During the start phase, the dialysate pressure could not be reduced to a value
below 760 mmHg (measurement tolerance: ±30 mmHg, test running time
120 seconds).
– The loading pressure is too high
– The UF pump is 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).
– The D-A converter (IC11) on PCB LP 632 is defective
– The operational amplifier (IC1/IC3) on PCB LP 632 is defective
– Feedback (P_DIAL, X633L/B6) X632/A29 defective
F20 pos. Pressure Positive pressure holding test failed. A pressure drop by more than
±80 mmHg/min was detected in the hydraulic system during flow-off.
– Leakage in the hydraulic system
– The UF pump spring is defective
– ASP does not 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/... not 24 V
– Control line (AIR_SEP–/C22) ASP/... not 0 V
– Feedback (ACKN_ASP, X634L/B10) X632/A19 not 12 V.
F23 pos. Pressure Pressure drop in the hydraulic system during the measuring phase (8 seconds).
Change larger than +4 digits or larger than -8 digits.
– Leakage in the pump segment of the air separation pump
– Leakage in the heat exchanger
– Feedback (P_DIAL, X633L/B6) X632/A29, voltage change too large
F28 pos. Pressure ASP functional test (running and delivery test)
– ASP line segment occluded
– ASP line segment incorrectly inserted (check direction of delivery)
– ASP not running (electrically or mechanically).
– V87 electrically or mechanically closed
F01 UF function The pause between the strokes of the UF pump 1 was shorter than 220 ms.
Correct volume delivery is not ensured to inadequate return length.
– The pump rate outputted by CPU1 is too high
F02 UF Function The pulse time for the UF pump 1 is shorter than 180 ms. Correct volume
delivery is not ensured due to inadequate ejection time.
– The monoflop on PCB LP 634 is defective (IC42/R82/C47)
F03 UF Function The pulse time for the UF pump 1 is longer than 500 ms. A maximum rate of
5000 ml/h is not possible.
– The monoflop on PCB LP 634 is defective (IC42/R82/C47)
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.
– The D-A converter (IC11) on PCB LP 632 is defective
– The operational amplifier (IC1/IC3) on PCB LP 632 is defective
F01 Conductivity The conductivity was not within the scale limits or was not stable within 10
minutes (±0.1 mS/10 sec).
– N concentrate connected
– Feedback (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).
– Feedback (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).
– Feedback (COND_SIG, X633L/B8) X632/A22 insufficient
– Detuning (COND_DET, X632/A21) X633L/B31 insufficient
F05 Conductivity CPU1 failed to transmit a bibag® status message within 3 seconds.
– Runtime problem (software).
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) not 12 V
– PCB LP 633-5 T2 or IC26 defective
F01 DIASAFE plus Available options and DIP switch settings do not match.
F01 HPU
CPU1 system status (MST), HPU status and DIP switch / array 2 changed
during the test running time.
– DIASAFE plus:
CPU2: Array 2, DIP switch 2 not OFF
CPU2: Array 2, DIP switch 3 not OFF
– MST transmitted by CPU1 does not match the DIP switch settings of array 2.
– DIP switches / array 2 changed during the test running time.
– HPU logged off
F34 DIASAFE plus Pressure holding test failed. Max. number of treatments exceeded?
– Diasafe filter membranes leaking / worn.
F02 DIASAFE plus Dialysate outlet pressure (DA1) outside the permissible ranges (10 seconds).
F02 HPU Test range for DA1 –25 mmHg² P_dial ² 55 mmHg
– Feedback DA1 (P_DIAL, X633L/B6) X632/A29
– Feedback line DA2 (see HPU diagram)
F03 DIASAFE plus Cross-comparison of both pressure transducers (DA1 / DA2) is outside the
F03 HPU acceptable tolerance (10 seconds).
P(DA2) == P(DA1) ±20 mmHg
– Feedback DA1 (P_DIAL, X633L/B6) X632/A29
– Feedback line DA2 (see HPU diagram)
F41 DIASAFE plus Test valve V183 leaking. Pressure increase in the system of DP(DA2) >
F41 HPU 30 mmHg within 4 seconds.
– V183 open, contaminated, mech. defective
– HPU, output stage etc. defective
F42 DIASAFE plus No pressure increase of DP(DA2) > 200 mmHg within 4 seconds after opening
F42 HPU test valve V183 in the system.
– V183 fails to open, mechanically defective
– Compressor P185 defective, not running
– HPU, V183 and/or compressor P185 output stage etc. defective
F43 DIASAFE plus Lower pressure test range of DP(DA2) > 300 mmHg not achieved within
F43 HPU 1 second after closing test valve V183.
– HPU, output stage etc. defective
F44 DIASAFE plus The upper pressure test range of DP(DA2) 750 mmHg was exceeded within
F44 HPU 4 seconds after closing of test valve V183.
– HPU, output stage etc. defective
F04 DIASAFE plus The air separation pump P97 is running although valve V43 is closed.
– HPU, output stage etc. defective
F26 DIASAFE plus Insufficient test pressure (P < 750 mmHg) in the system.
– Hydraulic system leaking
F27 DIASAFE plus After the valve V189 opened, the pressure drop in the system was insufficient
(DP < –70 mmHg).
– Valve V189 electrically or mechanically not open
– Diasafe filter severely contaminated
– Filter before/after V43 severely contaminated
F28 DIASAFE plus No pressure increase in the system above P > 760 mmHg.
– Diasafe filter membrane leaking (major leakage)
– No Diasafe filter installed
F29 DIASAFE plus Pressure holding test failed. Pressure drop within a measurement time of
30 seconds (DP > –10 mmHg) excessive.
– Diasafe filter membrane leaking
F30 DIASAFE plus During the pressure holding test, valve V189 was closed (according to electronic
feedback).
– Valve control failed
F34 DIASAFE plus See between F01 and F02 DIASAFE plus
F41 DIASAFE plus See between F01 and F02 DIASAFE plus
F42 DIASAFE plus See between F03 and F04 DIASAFE plus
F43 DIASAFE plus See between F03 and F04 DIASAFE plus
F44 DIASAFE plus See between F03 and F04 DIASAFE plus
F01, F02 and F03 cause the V84 monitoring flag to be set. This means
after one of these error messages has occurred Bergström or ISO-UF
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 remedy can be found in Service mode (by a service
technician only) in the NOVRAM menu item (clear V84 malfunction).
7.2.2 PSW (pressure switch) monitoring during free rinsing (only devices with CDS)
Rinse Failure F05 Rinse-free program with following Dis or HDIS or mandatory rinse as individual
program in Dis I – V.
Pressure switch for PSW_104 (S124) (bicarbonate) could not be opened.
– Pressure on ring main > 500 mbars (according to specification max.
500 mbars permissible). Pressure peaks on ring main: Frequently occurs in
spur line systems, for example if several patients are disconnected
simultaneously and disinfection is started.
– Switching point of pressure switch too low:
Required = 700 mbars ±20 mbars
– Check feedback of pressure switch on PCB LP 633-5:
Concentrate: X633L/A20
Rinse Failure F06 Rinse-free program with following Dis or HDIS or mandatory rinse as individual
program in Dis I – V.
Pressure switch for PSW_102 (S123) (concentrate) could not be opened.
– Pressure on ring main > 500 mbars (according to specification max. 500
mbars permissible). Pressure peaks on ring main: Frequently occurs in spur
line systems, for example if several patients are disconnected
simultaneously and disinfection is started.
– Switching point of pressure switch too low:
Required = 700 mbars ±20 mbars
– Check feedback of pressure switch on PCB LP 633-5:
Concentrate: X633L/A20
Rinse Failure F07 Rinse-free program, Dis, HDIS, or mandatory rinse in Dis I to 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 splinters or dirt in orifice 151, remove the tube and purge from both
ends)
– Check negative pressure and orifice (89)
(To do so, remove the tube and purge from both ends)
– Check CDS valve (104)
– Check CDS path for leaks
– Check feedback of pressure switch on PCB LP 633-5:
Bicarbonate: X633L/A19
– Cartridge filter (F210) upstream of degassing pump clogged or wrong filter
(filter for disinfectant container) installed. Filters can be distinguished by
different adapters.
Rinse Failure F08 Rinse-free program, Dis, HDIS, or mandatory rinse in Dis I – V.
Pressure drop during the monitoring phase on PSW_102 (S123) (concentrate)
or pressure build-up impossible.
– Check switching point of pressure switch
– Check loading pressure
(possibly splinters or dirt in orifice 151, remove the tube and purge from both
ends)
– Check negative pressure and orifice (89)
(To do so, remove the tube and purge from both ends)
– Check the check valve (117) and filter (119)
– Check CDS valve (102)
– Check CDS path for leaks
– Check feedback of pressure switch on PCB LP 633-5:
Concentrate: X633L/A20
– Cartridge filter (F210) upstream of degassing pump clogged or wrong filter
(filter for disinfectant container) installed. Filters can be distinguished by
different adapters.
Rinse Failure F09 Five minutes before the end of the mandatory rinse in Dis I – V.
The pressure switch PSW_104 (S124) (bicarbonate) or PSW_102 (S123)
(concentrate) did not open after pressure reduction.
See device error F12.
Rinse Failure F12 Rinse-free program with following Dis or HDIS or mandatory rinse as individual
program in Dis I – V.
The pressure switch for PSW_104 (S124) (bicarbonate) and for PSW_102
(S123) (concentrate) could not be opened.
– Membrane pumps fail to run
– V102 or V104 fails to open
– Pressure on ring main > 500 mbars (according to specification max. 500
mbars permissible). Pressure peaks on ring main: Frequently occurs in spur
line systems, for example if several patients are disconnected
simultaneously and disinfection is started.
– Switching point of pressure switch too low:
Required = 700 mbars ±20 mbars
– Check feedback of pressure switch on PCB LP 633-5:
Bicarbonate: X633L/A19
Rinse Failure F13 Rinse-free program with following Dis or HDIS or mandatory rinse as individual
program in Dis I – V.
Pressure drop during the monitoring phase on PSW_104 (S124) (bicarbonate)
and PSW_102 (S123) (concentrate) or pressure build-up impossible.
– Check switching point of pressure switch
– Check loading pressure
(possibly splinters or dirt in orifice 151, remove the tube and purge from both
ends)
– Check negative pressure and orifice (89)
(To do so, remove the tube and purge from both ends)
– Check the check valve (117) and filter (119)
– Check CDS valve (102/104)
– Check CDS path for leaks
– Check feedback of pressure switch on PCB LP 633-5:
Bicarbonate: X633L/A19
Concentrate: X633L/A20
– Cartridge filter (F210) upstream of degassing pump clogged or wrong filter
(filter for disinfectant container) installed. Filters can be distinguished by
different adapters.
In case of F07, F08 and F13, the DO NOT SWITCH OFF !! message
may be displayed in addition to the error number.
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.
7.2.3 Rinse section test (check of V91, V99, V100) (only devices with CDS)
Rinse Failure F11 Three minutes before the end of the mandatory rinse in Dis I – V.
The pressure switch PSW_102 (S123) (concentrate) did not open after pressure
reduction.
– Pressure on distribution line > 500 mbars (according to specification max.
500 mbars permissible). Pressure peaks on ring main: Frequently occurs in
feeder line systems, for example if several patients are disconnected
simultaneously and disinfection is started.
– Switching point of pressure switch too low:
Required = 700 mbars ±20 mbars
– Membrane pumps fail to run
– V102 fails to open electrically or mechanically
– Check feedback of pressure switch on PCB LP 633-5:
X633L/A20
V91/V100 Failure Three minutes before the end of the mandatory rinse in Dis I – V.
V91 or V100 cannot be opened.
– V91 or V 100 fail to open electrically:
PCB 634: V91 = X634L/A12; V100 = X634L/C13
– V 91 or V 100 mechanically not open:
Check filter (148) before V100, or valves clogged
– V99 constantly open (electrically PCB LP 634: X634L/B12 or mechanically)
– V 102 not open
– Pressure switch for PSW_102 (S 123) fails to switch
V99 Failure Three minutes before the end of the mandatory rinse in Dis I – V.
V99 cannot be opened.
– V 99 fails to open electrically:
PCB LP 634: X634L/B12
– V 99 fails to open mechanically:
Check filter (149) before V99, or V99 clogged
– Pressure switch for PSW_102 (S123) fails to open
V130 Failure Three minutes before the end of the mandatory rinse in Dis I – V.
V130 cannot be opened.
– V130 electrically defective:
PCB LP 634: X634L/A4
– V130 mechanically defective or clogged
– Pressure switch for PSW_102 (S123) fails to open
– Check the tubing for the bicarbonate suction line and the bibag® block
Rinse Failure F14 Shortly before the end of the mandatory rinse in Dis I – V.
Rinse section test not completed correctly. Possibly caused by flow problems.
7.2.4 Rinse section test (check of V91 and V98) (only devices without CDS)
Rinse Failure F14 Three 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.
V91 Failure Three minutes before the end of the mandatory rinse in Dis I – V.
After V91 has opened, no flow > 950 ml/min was set. V91 or valve V98
defective.
Rinse Failure F14 Shortly before the end of the mandatory rinse in Dis I – V.
Rinse section test not completed correctly. Possibly caused by flow problems.
7.2.5 Rinse section test (check of V91, V99, V100, V130) (only devices without CDS)
Rinse Failure F15 Three minutes before the end of the mandatory rinse in Dis I – V.
DS (bibag® pressure switch 134) could not be opened at the beginning of the
test.
– Check pressure switch: Switching point: Required: 130 mbars +30 mbars
– Bicarbonate pump no suction
– V91 constantly electrically or mechanically open
– V99/100 constantly electrically or mechanically closed
V91 Failure Three minutes before the end of the mandatory rinse in Dis I – V.
V91 cannot build up pressure on DS (bibag® pressure switch 134).
– Pressure switch fails to close mechanically: Check switching point
– V91 fails to open electrically: PCB LP 634: X634L/A12
– V91 fails to open mechanically (possibly clogged)
– V130 electrically not closed: PCB LP 634: X634L/A4
– V130 mechanically not closed (possibly clogged)
– bibag® connector leaking (check O rings)
– Sealing on the bicarbonate suction tube leaking
– Check feedback of pressure switch on PCB LP 633-5:
X633L/A8
– V99 constantly electrically or mechanically open
V100 Failure Three minutes before the end of the mandatory rinse in Dis I – V.
V100 cannot build up pressure on DS (bibag® pressure switch 134).
– V100 fails to open electrically: PCB LP 634: X634L/C13
– V100 fails to open mechanically (possibly clogged)
– V91 constantly electrically or mechanically open
– Concentrate pump fails to pump
– Filter (148) clogged
– Pressure switch fails to open
Rinse Failure F16 Three minutes before the end of the mandatory rinse in Dis I – V.
DS (bibag® pressure switch 134) cannot be closed. V99 or V130 leaking.
– V91 fails to open electrically or mechanically
– V99 constantly electrically or mechanically open
– V130 constantly electrically or mechanically open
– Sealing on the concentrate suction tube leaking
– Pressure switch fails to close
V99 Failure Three minutes before the end of the mandatory rinse in Dis I – V.
DS (bibag® pressure switch 134) cannot be opened. V99 does not open.
– V99 fails to open electrically or mechanically
– V100 fails to open electrically or mechanically
– Pressure switch fails to open
– V91 electrically or mechanically open
– Filter (149) before V99 clogged
Rinse Failure F17 Three minutes before the end of the mandatory rinse in Dis I – V.
DS (bibag® pressure switch 134) cannot be closed.
– V91 fails to open electrically or mechanically
– V130 electrically or mechanically open
– V100 electrically or mechanically open
– Pressure switch fails to close
V130 Failure Three minutes before the end of the mandatory rinse in Dis I – V.
DS (bibag® pressure switch 134) cannot be opened.
– V130 fails to open electrically or mechanically
– Pressure switch fails to open
– Check the tubing for the bicarbonate suction line and the bibag® block
– Bicarbonate line squeezed at strain relief
– Narrowing in the reducer on the bibag® connector
Rinse Failure F 20 Pressure switch (134) cannot be closed via V91 / 100
– V91 fails to open electrically or mechanically
– V130 / V188 electrically or mechanically open
– Pressure switch fails to close
V188 Failure The pressure on pressure switch (134) cannot be reduced via V188.
– V188 fails to open electrically or mechanically
– Pressure switch fails to open
– Check the tubing for the concentrate suction line and the air separation block
– Concentrate line squeezed at strain relief
Rinse Failure F14 Shortly before the end of the mandatory rinse in Dis I – V.
Rinse section test not completed correctly. Possibly caused by flow problems.
V39 Failure On opening V39 a difference in pressure is detected on the dialysate pressure
transducer (182) (averaged value V39 open; averaged value V39 closed):
bibag® device: < 20 mmHg
– V39 fails to open or close electrically or mechanically (possibly hydraulic
processing unit defective)
– Degassing pump cannot be adjusted (PCB LP 634).
– V91, V99, V100 fails to open electrically or mechanically
– Dialysate pressure transducer (182) defective or not calibrated (possibly
HPU P.CB LP 941 defective)
– Filter 210 (before degassing orifice) clogged
7.2.7 Further messages which may be displayed before or during a cleaning program
Shunt cover open Start of a cleaning program or during a cleaning program in RI I – II, HR I – III,
Dis I – V.
The shunt cover is not closed.
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 suction tube is not connected to the rinse chamber.
Reconnect the concentrate suction tube 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 suction tube is not connected to the rinse chamber.
Reconnect the bicarbonate suction tube to the rinse chamber.
Water alarm (low water During a cleaning program in RI I – II, HR I – III, Dis I – V.
alarm) The float switch transmits the “no water” message for more than 10 seconds.
The balancing chamber has stopped; V41 is permanently open.
When the error is eliminated the message is automatically cleared.
Water alarm (excess water) During a cleaning program in RI I – II, HR I – III, Dis I – V.
The float switch fails to signal that water is required for more than 30 seconds
(not applicable to recirculation programs).
The device continues to run.
When the error is eliminated the message is automatically cleared.
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.
Heater Error 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.
The heater signal (PCB LP 633-5: X633R/A26) does not change for
> 40 seconds.
Watchdog Error This error message can only be displayed shortly after turning power on.
Turn the device off and back on again.
Check the WD relay and components. Check CPU2/CPU1.
Check the plug connectors on the monitor.
NTC 109 switched off No valid value was stored on start-up in the NOVRAM. The temperature
difference between NTC109 and NTC3 is too high.
Switch off NTC 109 in the SETUP MENU, or recalibrate the temperature.
CPU II SYS failed CPU2 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 do not match
– Hardware defect on CPU2
Cyclic PHT F03 IC1 or IC3 on PCB LP 632 is defective, or device leakage
Cyclic PHT F04 Test could not be completed within a specific time interval
Shunt cover open – PCB LP 633-5 C24 (100 nF) temporarily short-circuited
(temporarily) – Shunt interlock defective (check switches)
UF1 volume - Error Failure to pass the test for an UF pump. The fill volume for the secondary air
separator is outside the tolerance of 100 ml ±4 ml.
Possible causes:
– The UF pump fails to deliver correctly (not calibrated or mechanical defect)
– If the test result is > 104 ml, the problem can also be caused by air coming
from a poorly deaerated dialyzer
F327 UF failure Pause between two UF1 pump strokes less than 220 ms.
Possible cause:
– CPU1 defective
F328 UF failure Pulse time of one UF1 pump stroke less than 180 ms.
Possible cause:
– Actuating monoflop on PCB LP 634 defective
F329 UF failure Pulse time of one UF1 pump stroke exceeds 500 ms.
Possible cause:
– Actuating monoflop on PCB LP 634 defective
F331 UF failure Theoretical / actual rate of the UF1 pump deviates by more than ±10 %.
Possible cause:
– System error
F332 UF failure UF1 pump stopped for more than the maximum time period.
Possible causes:
– Actuating output stage on PCB LP 634 defective
– UF pump interruption
– System error
F333 UF failure Volume changes by more than 10 ml during specified standstill (only monitored
if "Blood detected" (optical detector dark)).
Possible cause:
– System error
F350 UF failure A difference of more than 100 ml between the CPU1 and the CPU2 volume is
detected during an UF data transfer after turning the UF unit on.
Possible cause:
– System error
F351 UF failure CPU2 could not detect plausibility of the CPU1 UF parameters.
Possible cause:
– 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 cause:
– System error
F363 UF failure CPU2 repeatedly did not receive a complete UF parameter set.
Possible cause:
– System error
F364 UF failure UF1 volume change although the UF goal has already been reached.
Possible cause:
– System error
HPU Error E00 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
– Problem on PCB LP 1631
– Problem on PCB LP 630
HPU Error E01 Cyclic communication has failed for more than 2 seconds.
– System error
HPU Error E07 The HPU was logged off by the monitor. Not generated because CPU1 has
already stopped communication.
– System error
HPU Error E15 Error in the HPU software. Valves are activated incorrectly.
– System error
HPU Error E98 Transition to the T1 test is not allowed after restart.
– System error
BPM: Measurement value Blood pressure cuff not correctly connected. Leakage in pressure tube. Alarm
outside the alarm limits limits not adjusted to the patient.
BPM: Cuff cannot be inflated. CPU-P1 pressure < 25 mmHg 15 seconds after start of a measurement
E72 BPM error Pressure difference between CPU-P1 and CPU-P2 on 1st stage > 20 mmHg
(Remove the cuff from the
patient!)
F83 BPM error CPU-P1 pressure zero point drift after T1 test
(Remove the cuff from the
patient!)
E84 BPM error CPU-P2 pressure zero point drift after T1 test
(Remove the cuff from the
patient!)
E86 BPM error CPU-P2 pressure > 300 mmHg for more than 15 seconds
(Remove the cuff from the
patient!)
E90 BPM error CPU-P2 pressure > 330 mmHg for more than 300 ms.
(Remove the cuff from the
patient!)
E91 BPM error CPU-P2 pressure > 15 mmHg for more than 180 seconds
(Remove the cuff from the
patient!)
E93 BPM error CPU-P1 reference voltage deviation. Valid range: 1.4-1.6 V
(Remove the cuff from the
patient!)
E94 BPM error Deviation +12V pump voltage. Valid range: 11-13 V
(Remove the cuff from the
patient!)
E96 BPM error Deviation of calibration parameters between RAM and EEPROM
(Remove the cuff from the
patient!)
E98 BPM error Pressure change during measurement ≤ 3 mmHg / 5 milliseconds within
(Remove the cuff from the 25 seconds. This monitors detection of a pressure stage.
patient!)
E99 BPM error Pressure difference between CPU-P1 and CPU-P2 on 1st stage > 20 mmHg
(Remove the cuff from the
patient!)
Download error 011 Value range exceeded for UF or Na+ profile number.
Download error 013 Value range exceeded for base Na+ / target Na+ or plausibility of adjustment
range ±(0 – 13) mmol.
Download error 019 Value range exceeded or plausibility error for start Na+.
Download error 020 Block check of UF rate, UF goal, UF time, UF profile. Na+ profile, Base Na+,
prescribed Na+, Start Na+.
Download error 035 ISO UF data programmed although UF data have been transferred.
Warning
The precision of the measuring equipment used during calibration is key
to the accuracy of the OCM measurement.
The measuring equipment used for calibrating the conductivity must
have a precision of 0.05 mS/cm in the temperature range 35 °C to
39 °C.
Printer module
9 Calibration / adjustment
9.1 CALIBRATION
Note
Before starting calibration on the hydraulics unit, any deposits detected
must be removed by running an appropriate disinfection program.
LM
DIAGNOSTICS
LM
MISCELLANEOUS
LM
SETUP MENU
LM
Setting the blood pump stop alarm (see Chapter 9.1.5 on page 9-6)
Calibrating the Single-Needle blood pump (see Chapter 9.1.11 on page 9-10)
(Single-Needle pressure) (option)
Setting the current increasing pulse (see Chapter 9.1.15 on page 9-13)
Setting the Hall sensors in the heparin pump (see Chapter 9.1.46 on page 9-38)
CALIBRATION
Key
Conf
LM
Key
CAL. ART. EBM see part 2
Conf
LM
LM
Key
CAL. VENOUS EBM Conf see part 4
LM
Key
CALIB. (B)-PUMP-RATE Conf see part 5
LM
LM
Key
CAL. DEGAS. PRESSURE Conf
see part 7
LM
Key
CAL. FLOW 300 ml/min Conf
see part 8
LM
Key see part 9
CAL. FLOW 500 ml/min Conf
LM
Key
CAL. FLOW 800 ml/min Conf
see part 10
LM
Key
CALIB. TEMPERATURE Conf
see part 11
LM
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
LM
Key
RESET FAILURE RECORD Conf see part 17
LM
Key
NOVRAM Conf see part 18
LM
Key
back to menu ? Conf
LM
Navigation
Menu display Description
Key
Conf
LM Key
Audio paused
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
LM display, the arterial pressure art.gain.: +210 mmHg
display and the reference
instrument must be identical.
Check whether the scale limits Apply ≥210 mmHg to art.
can be reached pressure transducer
Tolerance: ±10 mmHg (reference instrument!)
Key
Esc Set the value of the
reference instrument on
the display by pressing
the +/- keys
Key
Audio paused
Note:
If calibration of this function is
impossible, the CAL. ART. DATA STORED
EBM mode must first be run.
After approx. 3 seconds
Note
The accuracy of the pressure gage used must correspond to that of the
UMED or HMED.
The accuracy of the pressure gage used must at least correspond to the
following values:
–1 to 2 bars: ±5 mbars
2 to 8 bars: ±20 mbars
Key
Conf
Key
art.press: XXX mmHg
Esc
Arterial pressure
transducer open to
atmosphere
9.1.5 Without menu display: Setting the blood pump stop alarm
Key
Conf
LM Key
Audio paused
Key
Ven. PRESS. CHECK Conf
ACKNOWLEDGED
LM ven.press: ±0 mmHg
Key After approx. 3 seconds
back to menu ? Conf Activate various pressure values.
The values on the display, the venous
LM pressure display and the reference
instrument must be identical.
ven.gain.: +210 mmHg
Check whether the scale limits can be
reached.
Connect the external
Tolerance: ±10 mmHg
reference instrument
Key
Audio paused
Note:
If calibration of this function is
impossible, the CAL. VENOUS DATA STORED
EBM mode must first be run in
the level detector.
After approx. 3 seconds
Note
The accuracy of the pressure gage used must correspond to that of the
UMED or HMED. The accuracy of the pressure gage used must at least
correspond to the following values:
–1 to 2 bars ±5 mbars
2 to 8 bars ±20 mbars
9.1.7 Part 4: Calibrating the venous pressure measurement in the level detector
Key
Conf
Key
ven.press: XXX mmHg Esc
ven.press: ±0 mmHg
Key
Esc
Note:
Check zero point and slope; repeat
the procedure if necessary.
Note:
If adjustments are made to the air
detector, the CAL. VENOUS
PRESSURE menu item must be
run.
Potentiometer
Potentiometer
PCB LP 4
CALIB. (B)-PUMP-RATE
Key
Conf
LM
Key
CALIB. SN. BP-RATE see part 5.2
Conf
LM
Key
back to menu ? Conf
LM
Key
Conf
Key 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
LM Key
Set various delivery rates on
Audio paused
the arterial blood pump.
Key The values on the display
back to menu ? Conf and the BP must be
DATA STORED
identical.
LM
Key After approx. 3 seconds
Esc
Note: Set the line 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 (+/-).
Key
Conf
Note: Set the line 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 (+/-) keys.
Upper switching point 110 130 150 172 195 219 244 270 299
(mmHg) ±7 mmHg
2. Press the and (+/-) keys to set the stroke volume and confirm with Start/Stop.
9.1.11 Without menu display: Calibrating the Single-Needle blood pump (Single-Needle
pressure) (option)
Upper switching point 110 130 150 172 195 219 244 270 299
(mmHg) ±7 mmHg
Note
It may be necessary to change the Single-Needle stroke volume (see
Chapter 9.1.10 on page 9-9):
– Simultaneously press the and Start/Stop keys.
– Press the and (+/-) keys to set the stroke volume and confirm
with Start/Stop.
Key
Conf
Key Key
UF pump 1 Conf pulse amount = 60 Esc
ACKNOWLEDGED
Key
press UF key Esc
Key
UF I/O UF pulses left = 60
Note: The remaining UF strokes are
Check the volume. Adjust indicated on the display.
the UF pump if necessary Display field indicates the
and repeat the procedure. number of preselected strokes.
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
measuring cylinder
– Use a measuring cylinder with a maximum tolerance of ±0.5%.
Key
Conf
Key
adjust degas.-press. Esc
Key
Audio paused
DATA STORED
See also degassing pump pressure (see Chapter 9.2.2 on page 9-42).
DATA STORED
Note
If the 300 / 500 / 800 flow rates cannot be set or flow alarm problems
are incurred after "Calibrate flow", the setting of the current increasing
pulse may be the cause.
Note
The flow selected first is accompanied by the DIASAFE-filling act.
message which is displayed for the duration of 17 balancing chamber
switchings.
MP1: 1 V/cm
GND
MP8: 2 V/cm
9.1.16 Alternative method of setting the current increase (if an oscilloscope is not
available)
– Select CAL. FLOW 300 ml/min. There may be two device reactions.
Either it initiates regular balancing chamber switchings. In this case, proceed as described for case 1;
or the device is in "Eigentakt" (intrinsic clock pulse) mode. Then proceed as described for case 2.
Note
After setting the current increasing pulse, check and, if necessary,
adjust the 300 / 500 / 800 flow rate settings.
DATA STORED
DATA STORED
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 externally connected measuring instrument: ±0.2 °C.
Temp. ADJUSTMENT
adj. temp to 37 °C
Key
Conf
XXXX ADC digits
Key
adj. temp to 37 °C Esc
XXXX DAC digits
Connect the external reference instrument.
Key
OCM TEMP.-Adjust Esc
Device in bypass
NTC3, 12 bit
NTC3 temperature
NTC4, 12 bit
Dynamic measuring range switching
Note
The hydraulic unit must be installed, the rear panel closed and the
DIASAFE® plus covered.
Check TEMPERATURE
XXX.X °C
set temp = XX.X °C
Specify a temperature by
XXXX ADC digits
pressing the +/- keys.
alpha temperature
Key display setting
Audio paused
Note
The hydraulic unit must be installed, the rear panel closed and the
DIASAFE® plus covered.
OCM TEMP.-Check
OCM TEMP.-Check
Key
Conf
XXXX °C
act temp = 37.0 °C
XXXX ADC digits
Use to select the
Note
The hydraulic unit must be installed, the rear panel closed and the
DIASAFE® plus covered.
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
The membrane pumps must be run in to adjust the concentrate and the bicarbonate pump to operating
temperature before their volume is measured in liters.
The suction rods (bicarbonate / concentrate) are located in a container filled with water.
Run-In PUMPS
Key
Conf
Key
START MAND. FILLING? Esc
Key
Audio paused
Key
MAND. FILLING active Esc
After 9 seconds
Key
Press ALARMTONE MUTE Esc
Key
Audio paused
Key
mem puls left = 1000 Esc
Key
Conf
Key
BC-Volume = 30.00 ml Esc
In case of balancing
chambers WITH volume
label:
Read the volume label on
In case of balancing
chambers WITHOUT volume
label: Remove the drain line
from the device, collect two
consecutive pulses of fluid,
measure the volume and
divide it by two.
e.g.:
BC-Volume = 30.19 ml
Key
Audio paused
DATA STORED
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 result when using an incompatible
measuring cylinder
– Use a measuring cylinder with a maximum tolerance of ±0.5%.
cal. CONC.-PUMP-VOL
Key
Conf
Key
CONP-Vol = 0.828 ml Esc
Key
Audio paused
DATA STORED
Note
Incorrect measurement result when using an incompatible
measuring cylinder
– Use a measuring cylinder with a maximum tolerance of ±0.5%.
9.1.27 Part 12.4: Measuring the volume of the concentrate pump in liters
Key
Conf
Key
START MAND. FILLING? Esc
Key
Audio paused
Key
MAND. FILLING active Esc
After 9 seconds
Key
conc pulses = 100 Esc
Key
Audio paused
ACKNOWLEDGED
Key
Press ALARMTONE MUTE Esc
Key
Audio paused
Key
conc puls left = 100 Esc
Notes:
100 strokes are factory-set. This setting can be changed by pressing the +/-
keys (depending on the measuring cylinder used). However, on returning to
CAL. MIXING-SYSTEM the display will indicate the factory setting
again!
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
measuring cylinder
– Use a measuring cylinder with a maximum tolerance of ±0.5%.
calib. BIC.-PUMP-VOL
Key
Conf
Key
BICP-Vol = 1.050 ml Esc
Key
Audio paused
DATA STORED
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
measuring cylinder
– Use a measuring cylinder with a maximum tolerance of ±0.5%.
9.1.29 Part 12.6: Measuring the volume of the bicarbonate pump in liters
Key
Conf
Key
START MAND. FILLING? Esc
Key
Audio paused
Key
MAND. FILLING active Esc
After 9 seconds
Key
bic pulses = 50 Esc
Key
Audio paused
Key
ACKNOWLEDGED Esc
Key
Press ALARMTONE MUTE Esc
Key
Audio paused
Key
bic pulse left = 50 Esc
Notes:
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
measuring cylinder
– Use a measuring cylinder with a maximum tolerance of ±0.5%.
Key
Conf
Key
START MAND. FILLING? Esc
Key
Audio paused
Key
MAND. FILLING active Esc
After 9 seconds
Key
conc pulses = 50 Esc
Key
Audio paused
Key
ACKNOWLEDGED Esc
Key
Press ALARMTONE MUTE Esc
Key
Audio paused
Key
conc puls left = 50 Esc
Notes:
Notes:
This test step verifies the concentrate or bicarbonate pump
volumes in accordance with the parameters entered for the mixing
system (mixing ratio, BC volume, Conc. and BIC 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
measuring cylinder
– Use a measuring cylinder with a maximum tolerance of ±0.5%.
CALIB. CONDUCTIVITY
Key
Conf
Key
CONDUCTIVITY Set see part 13.1
Conf
LM
Key
TEMP/COND COMP Calib see part 13.2
Conf
LM
LM
Key
CONDUCTIVITY Check Conf see part 13.4
LM
Key
OCM Cond.-Check Conf see part 13.5
LM
Key
TEMP/COND COMP Check see part 13.6
Conf
LM
Key
back to menu ? Conf
LM
CONDUCTIVITY Set
Key
Conf
Use to select the concentrate setting field
If no key is
If no key is conc. set = -X% pressed for
conc. set = ±0% pressed for approx. 4 sec
approx. 4 sec
Use +/- to reduce the concentrate Use +/- to raise the concentrate pump
pump volume to get to a CD in the lower volume to get to a CD in the upper
display range. display range.
e.g.:
Key Key
Audio paused Audio paused
ACKNOWLEDGED ACKNOWLEDGED
Key Key
Audio paused Audio paused
XXXX Steps
(concentrate pump)
XXXX Steps
(bicarbonate pump)
Device in bypass
XX.XX mS/cm
XX.XX mS/cm
conc. set = +X%
XX.XX mS/cm
Key
Audio paused
XX.XX mS/cm
ACKNOWLEDGED
alpha temperature
After approx. 3 seconds display setting
Key
Audio paused
DATA STORED
Key
XXXX mS/cm
OCM PULSE UP activ Esc
Key
OCM PULSE DOWN activ Esc Time elapsed since start of pulse
Negative OCM pulse duration.
calibration
Counter
OCM PULSE finished !
Concentrate adjustment
After approx. 3 seconds
CD cell 7, compensated CD value
Audio paused LED
is flashing.
Info sound.
Key
Audio paused
DATA STORED
Note
If the value is outside ±25, the conductivity measuring system of the
hemodialysis device must be checked.
CONDUCTIVITY Check
e.g.:
alpha concentrate bicarbonate temperature
display setting setting setting
conc. set = -6%
Key
Audio paused
CD cell 7; 12 bit / 8 bit switching
ACKNOWLEDGED
Steps for concentrate pump
OCM COND.-Check
If no key is
pressed for
XXXX ADC digits (OCM)
conc. set = ± 0%
approx. 4 sec
e.g.:
alpha concentrate bicarbonate temperature
display setting setting setting
conc. set = -6%
Key
Audio paused
CD cell 7; 12 bit
ACKNOWLEDGED
CD cell 7
Key
Esc
Key
Conf
act temp = XX.XX °C
Open the shunt cover.
The device is now in bypass mode. XX.XX mS/cm
Key
CD cell 110, compensated
Esc
CD cell 110, compensation factor
Note
The temperature / conductivity compensation test cross-checks the two
conductivity cells (7, 110).
The tolerance of the two conductivity cells must not exceed
0.05 mS/cm. If this tolerance is exceeded, the OCM pulse must be
calibrated.
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
The accuracy of the pressure gage used must correspond to that of the
UMED or HMED.
The accuracy of the pressure gage used must at least correspond to the
following values:
-1 to 2 bars ±5 mbars
2 to 8 bars ±20 mbars
DIALYSATE Pressure
Key
Conf
Key
adj.zero.: + XXX mmHg Esc
Switch on flow
Switch on flow
Repeat the
procedure until 0 and Enter the value indicated by the
–500 mmHg match external reference instrument by
Not
the external pressing the +/- keys.
OK
reference instrument.
Key
Audio paused
Key
Audio paused
DATA STORED
TMP-Check
Key
Conf
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.
PDIAL2 press-check
Key
Esc
alpha Flow
Note: display setting
Observe the venous
pressure!
CALIBRATE BLD
Key
Conf
Key Key
Adjust BLOOD-LEAK Conf volt. bll. = 5.0 V Esc
DATA STORED
Key
Conf
Key Key
BIBAG Temp.-Adjust Conf connect 10kΩ ±0.1% Esc
Key
LM
Audio paused
Key Key
BIBAG Cond.-Adjust Conf connect 104Ω ±0.1% Esc
DATA STORED
Connect the calibration resistor (104 Ω)
to connector X13.
After approx. 3 seconds
Key
Audio paused
ACKNOWLEDGED
Key
connect 56.2Ω ±0.1% Esc
Key
Audio paused
DATA STORED
LM
**
Key Key
BIBAG Cond.-Check Conf act.cond: XX.X mS/cm Esc
LM
Key * With test plug: 25 ?
back to menu ? Conf
** With test plug: 45.7 mS/cm or 84.5 mS/cm
LM
Key
Conf
Audible alarm
Key
Are you sure ? Esc
Key
Audio paused
ACKNOWLEDGED
9.1.45 Part 18: Initializing the NOVRAM, clearing mandatory rinse, clearing a V84
malfunction
Audible alarm
Key
Are you sure ? Esc
Key
Audio paused
ACKNOWLEDGED
Key
RESET Filterchange ? Esc
Key
Audio paused
ACKNOWLEDGED
NOVRAM
LM
Audible alarm
Key Key
Reset MAND. RINSE Conf Are you sure ? Esc
LM Key
Audible alarm Audio paused
Key Key
Reset V84 Are you sure ? Esc
Conf
ACKNOWLEDGED
LM Key
Audio paused
Key After approx. 3 seconds
back to menu ? Conf
ACKNOWLEDGED
LM BACK TO MAIN MENU ?
After approx. 3 seconds
9.1.46 Without menu display: Setting the Hall sensors in the heparin pump
Setting Hall sensor 1 – Briefly press the key (syringe plunger holder moves to its upper
end position)
– Disconnect Hall sensor 2 (remove plug)
– Insert syringe (e.g., type BD / Fresenius 20 ml)
– Press and hold the key (until the syringe plunger holder has
reached its lower end position).
– Adjust Hall sensor 1 so that the bottom of the plunger and the end of
the syringe's scale (0 ml) are on the same level.
There must not be any mechanical noise. If the error message E55
occurs during the Hall sensor adjustment, the message can be reset 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, the complete setting for Hall
sensor 1 has to be repeated.
– After adjusting Hall sensor 1, Hall sensor 2 has to be reconnected.
– Briefly press the key (syringe plunger holder moves to its upper
end position).
Setting Hall sensor 2 – 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 (until the syringe plunger holder has
reached its lower end position).
– Adjust Hall sensor 2 so that the bottom of the plunger is pressed
against the bottom of the syringe.
There must not be any mechanical noise. If the error message E55
occurs during the Hall sensor adjustment, the message can be reset 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, the complete setting for Hall
sensor 2 has to be repeated.
– Briefly press the key (syringe plunger holder moves to its upper
end position).
Hall sensor 1
Hall sensor 2
Note
Measuring equipment for measurement points in the hydraulic unit:
UMED, HMED or pressure gage
with a measuring range of –1 to +2.2 bars.
Condition Flow on
V41
A
A61
Note
If the pressure of the degassing pump was changed, make sure to
check the loading pressure and adjust if necessary.
If devices are operated on sites at high altitude (check height above sea
level), the specified negative degassing pressure cannot be reached.
Calibrate as follows:
The setting for the degassing pump has to be increased in increments
from a low speed until no significant increase of the degassing pump
pressure can be detected anymore. This setting can also be saved.
Note
If the loading pressure was changed, make sure to check the degassing
pump pressure and adjust if necessary.
A65
B
A78
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
measuring cylinder
– Use a measuring cylinder with a maximum tolerance of ±0.5%.
2
3
Measuring equipment UMED, HMED or pressure gage (e.g., 0–1 bars, accuracy ±1%) and
syringe. For measurement setup see the following illustrations.
General notes on the The calibration described below can be performed by means of a
bibag® pressure multimeter or the DIAGNOSTICS service menu.
transducer
To read the corresponding signal, you must select the menu option
E: CPU1_BIBAG_PSW in the diagnostic 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 Audio paused key.
Selection 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.
Confirm with Conf key.
– Use the and keys to select READ INPUTS.
Confirm with Conf key.
– Use the and keys to select READ DIGITAL INPUTS.
Confirm with Conf key.
– Use the and keys to select CPU1: RD DIGITAL INP.
Confirm with Conf key.
– E: Use the and keys to select CPU1_BIBAG_PSW.
Confirm with Conf key.
– The active levels 0000 or 1111 are still shown on the display.
Note
In the menu item E: CPU1_BIBAG_PSW, the active level is identified
by 1111.
The active level of the circuit output is LOW (< 1 V).
Fig.: 450-2
Potentiometer
LED D5
Potentiometer
LED D10
Potentiometer
Jumper J1
PCB LP 4
Luer-Lock adapter
Fluid level
Warning
For calibration of the air detector, the device must be in Service mode.
The ambient temperature should be between 15 °C and 35 °C.
Warning
The calibration using the air detector calibration set is only applicable to
devices running with Fresenius tubing systems.
Observe the “use by” date!
9.3.1.1 Calibration using the air detector calibration set (see setup instructions)
Measuring equipment UMED, HMED or pressure gage, adjusting block and checking
(reference) block
Checking the air detector – Fill the spherical recesses of the test block with grease and use a
spatula to remove any excess grease so that only the recesses are
completely filled with grease.
– Place the greased test block into the drip chamber holder. Ensure
that the ultrasonic sensors are correctly positioned in the spherical
recesses of the test block. The test block must not touch the holder
wall, but must hang freely between the sensors.
– LED D5 and LED D10 on PCB LP 450-2 must both be lit. If one or
both LEDs are not lit, the calibration must be repeated.
– Take the test block out of the drip chamber holder.
Remove residual grease using a lint-free cloth and an approved
disinfectant.
– In addition, the venous occlusion clamp has to be checked, and the
optical detector has to be calibrated (see Chapter 9.3.1.2 on
page 9-54).
Checking the air detector – Lower the fluid level in the venous bubble catcher:
An alarm must be generated. LED D5 and LED D10 light.
If one or both LEDs are not lit, the calibration procedure must be
repeated.
– Raise the fluid level in the venous bubble catcher:
It must be possible to clear the alarm; both LEDs are off.
– Remove the venous bubble catcher from the air detector.
– In addition, the venous occlusion clamp has to be checked, and the
optical detector has to be calibrated (see Chapter 9.3.1.2 on
page 9-54).
10 Servicing / repair
Precautions for working on Before working on the hemodialysis device, first read the information in
the device the following chapter (see Chapter 2.4 on page 2-2).
Warning
When the device is returned to use, check that the pressure of the water
supply meets the prescribed minimum pressure.
Installing and removing Unless described otherwise, installation of components is in the reverse
components order of their removal.
10.2 Equipment
Unisilkon grease
Threadlocker
(low/medium/high strength)
10.3.1 Monitor
9
8
2
7 3
6 5
EBM
18
3
17
16 4
5
15
14
13 6
12
7
8
11
9
10
Legend
19
20
V102
S123
P185 H54a
V100*
F76
V91
H89 V117
V24
S182 F210
F119
B A65
H151
V26 S9
P21
C V41
P22a
A61
F73
A78 V24b D P29 A
002
003
V92
H54 H95
V112
S12
S134
H66 V30
H90b
S202
CD132
H201
V188
F74
H77
P22
P97a
H94
H88
F148
F149
H68
V35
V36
H90a P21a
V189
V84
H205
P25 P23
X B2 X C1 X A7 X1
X S1 P-Dial 2
Pumpen / pumps Ventile / valves Sensoren / sensors CAN
X S2 N.C.
X 16
N.C. X R1 OCM_NTC4 X2 NTC2 X S3 N.C.
N.C.
Conc. P. Bic. P.
X 15 OCM_LF1 10 X3 NTC3 X S4 N.C.
CO1 BI1
X 14 NTC109 X5 FL-Switch X 17 X S5 Niveau Konz.
Kabelbaum / cable harness X 13 LF-Bibag 132 X6 Niveau 6 RJ-45 X S6 NTC308
X A5 X A1 X A2 X 12 Bibag NTC133 X7 LF 7 X S7 LF309
X 11 Bibag (LP1628) X8 P-Dial 1 (9) X R3 Bibag SW
X A6 X A4 X A3
X 10 ZKV PSW X9 Reedk. 10 X B1 X R2 V89 Sens.
BLD
LP 941 WTR / HPU
10.4.2 Torques
Luer-Lock: 2.3 Nm
10.5.3 Brakes
10.5.4.2 Microswitch
1 Pull off the cable from the monitor (1) and the
2 cable from the motherboard (2), disconnect
the heater rod cable (4), disconnect the EBM
3 power supply (3), pull off or unscrew the
ground cables, remove 2 screws, and pull the
power supply unit out of the housing to the
rear.
After replacement or repair, check the
voltages in the calibration menu, calibrate the
4
temperature, and check the temperature.
10.7 Monitor
Note
When replacing the PCBs, the Calibration and test steps after repair
(see Chapter 10.10 on page 10-54) must be followed.
10.7.5 Display
10.7.5.5 Backlight
1
Remove the plug-in boards from the monitor.
Pull off the connector (3) from PCB LP 636.
Press back the tabs (1) and remove
PCB LP 1131 (2).
Warning
Improper placing of the overflow tube will impede the exit air and
overflow of the hemodialysis device.
Defect in the hydraulics unit
When closing the hydraulics unit rear panel, always place the overflow
tube through the opening provided. Do not kink or squeeze the tubing
inside.
Removal
Installation
Removal
1
2
Installation
Removal
4
– Unscrew the strain relief (1) from the cap
3 (2).
1 – Unscrew the cap (2) from the connector
2
(3).
– Open the connector's strain relief.
– Release the cable wires (4).
– Expose the cables.
Installation
1 2
Pull off the cable from V43 (12) and the level
sensor (1).
Protect the other hydraulic components from
13 leaking fluid. Pull off the tubes and collect the
fluid (see Chapter 10.8.3.1 on page 10-27).
12
Unscrew 2 screws (10) and remove the
11 3
multifunction block.
10 4
When installing, ensure proper tubing
arrangement.
9
After replacement or repair, run the
degassing test and the fill program.
8 7 6 5
1
2 Pull off the tubes, unscrew the screws (5), lift
3
4 the heat exchanger a little and remove it.
The heat exchanger is operated based on the
counter-current principle:
1 Inlet of chamber A
5
2 Outlet of chamber B
3 Outlet of chamber A
4 Inlet of chamber B
1 1 to valve V30
2 to inlet of heater block H66b
2 4
3 to valve V87
4 to outlet of heater block H66a
After replacement or repair, check the flows.
10.8.7 UF pump
2
3
10.8.9.1 Pump
10.8.9.2 Motor
Installation:
Install in reverse order of removal.
Insert the cuvette (3), being careful to avoid
fingerprints or other soiling.
Any fingerprints or other soiling will invalidate
measurement results.
Position the cuvette cone (1) on surface (2).
After repair or replacement, calibrate blood
leak and dimness
(see Chapter 9.1.42 on page 9-36).
1
Solenoid valve with 1 adapter, low kv value V31-38, V43, V86, V89, V100, V102, V183, V188, V130
Warning
Risk of caustic burning!
To prevent any skin contact with the disinfectant, wear protective
gloves.
When working with acidic substances:
Wear goggles!
Observe the safety precautions of the disinfectant used!
In the event of contact with acid:
Eye: Immediately flush with flowing water for 15 minutes.
Skin: Use soap under flowing water for neutralization.
Ingestion: Do not induce vomiting, but have the person affected drink
plenty of still water. Seek medical advice.
Warning
Microbiological risks!
A defect of the disinfection valve can result in disinfectant in the
container becoming diluted with fluid entering it and thus reducing the
disinfecting effect.
The disinfectant container must be replaced following repair.
1
2
1
2 Pull off the reed switch cable from the HPU.
3 Pull off the inlet tubes (6) and rinse tubes (3).
4 Take the suction tubes out of the rinse
chamber, disconnect them from the tubes,
remove the screw (4), and pull the tubes
5 inwards and out of the rinse chamber adapter
(2).
6
Disconnect the tube (1) running to the
balancing chamber from the T-piece.
Unscrew the screws (5), lift the rinse chamber
a little and remove it.
When installing, ensure proper tubing
arrangement according to flow diagram.
After replacement or repair, run a rinse
section test.
1
Pull off the cable (1) from PCB LP 1628, take
the cables and tubes out of the holder (2), and
open
2 the clasp(3).
10.8.15.2 Microswitch
Warning
Risk of infection
Contamination of the hemodialysis device with blood results in a risk of
infection.
The following must be observed to avoid an infection:
– Wear safety gloves.
– Disinfect your hands after removing the gloves.
– Wear surgical mask and goggles if there is a risk of splashes and
aerosols.
Clean and disinfect the device before coming into contact.
Warning
Risk of infection
Contamination of the hemodialysis device with blood results in a risk of
infection.
If fluid may have passed through the hydrophobic filter, the device must
be checked for contamination after the treatment. If it is contaminated,
the device must be removed from service. Before starting the device
again, all affected parts must be replaced in accordance with the
manufacturer's specifications.
Checking the EBM front Check the housing front in the vicinity of the Luer-lock connectors for
residual blood, fluid and precipitation, especially at the following
positions:
– Venous pressure transducer
– Single-Needle pressure transducer (optional)
– Arterial pressure measurement unit
Checking the housing If blood or fluid enters into the housing main part or into other
main part components (e.g., PCB LP 450-2, PCB LP 950, BPM, etc.), these must
be cleaned or replaced.
Hydrophobic filters Check hydrophobic filters inside the device to find out whether they are
wetted with fluid.
1
2
10.9.6.3 Drive
10.9.6.4 Mechanism
1
2
3
4
1 Removal:
4 Open the EBM.
Pull off the cables (1).
2
Unscrew the screws (2).
Remove the card reader (3).
3
Installation:
Insert the spacer (4).
Install in reverse order of removal.
Check function.
Warning
A disinfection, a T1 test and a check of electrical safety must be
performed after working on the hemodialysis device, irrespective of the
table below.
PCBs
Power supply unit (power board, heater Check voltages (calibration menu), calibrate temperature, perform
board) temperature test
E-code of the power supply unit <050:
Heater board and power board must be
replaced together.
E-code of the power supply unit ≥ 050:
Heater board and power board can be
replaced separately.
PCB LP 630 Motherboard Check jumpers (see PCB LP 630 Motherboard on page 11-54)
PCB LP 1631 CPU 1 Check jumpers (see PCB LP 1631 CPU 1 on page 11-72), set the
DIP switches, install latest software version, initialize Novram, make
setup settings or import data, calibrate, set time and date (SYSTEM
CLOCK), check BPM function (option), check network / card reader
(option).
Battery CR 1225 – PCB LP 1631 CPU 1 Set time and date (SYSTEM CLOCK).
Snap-hat battery – PCB LP 632 CPU 2 Import calibration data or calibrate as required.
PCB LP 633-5 Input board Calibrate blood pump rate, arterial and venous pressure, blood leak,
bibag® values (temperature and conductivity), TMP, temperature,
conductivity and OCM.
Check pressure transducers 1 and 2 (hydraulics).
Check all analog signals.
Check jumper BR4 (see PCB LP 633-5 layout I on page 11-58).
PCB LP 634 Output board Set DIP switches, set current increase, flows, pressures (hydraulics),
temperature, degassing pump, blood leak, dimness
PCB LP 636 External connectors Jumper J1 must not be connected (see PCB LP 636 External I/O
board on page 11-61), check status indicator ("traffic light") function
Display, PCB LP 922; MDC-II board; Perform display test and key test.
backlight, touch panel If the MDC-II board was replaced, also update the software (see
Chapter 5.3 on page 5-73) and set the language variant (see
Chapter 5.2.3 on page 5-68).
PCB LP 950 for heparin pump Set hex switches (see Syringe type table on page 11-26), calibrate
Hall sensors
PCB LP 1131 Operation status indicator Check status indicator for proper functioning
(traffic light)
PCB LP 450-2 for air detector Set jumpers, calibrate air detector sections, optical detector, venous
pressure
(see PCB LP 450-2 Level detector control (LD) on page 11-50).
PCB LP 624 Blood pump Set hex switches, calibrate arterial pressure, check line diameter,
blood pump rate, stroke rate / volume (SN)
PCB LP 1628 Distributor Check bibag® switching states, check BPM function (option)
PCB LP 1626 Card reader (option) Insert the PatientCard in Standby mode.
Check function.
EBM
BPM module (optional) Leakage test, pressure test and check safety valve
Heparin pump; PCB LP 950; optical Set hex switches (see Syringe type table on page 11-26), calibrate
sensor Hall sensors
Hydraulics unit
Balancing chamber Measure balancing chamber volume in liters (only if no volume label),
read off balancing chamber volume (only with volume label),
calibrate balancing chamber volume, check flows and conductivity
Flow pump Set flows, check relief pressure, adjust current increase
Evacuation valve V188 Check ventilation after air has been sucked in
11 Functional description
MODUL
E T1
TEST
BYPASS
no STORAGE
TEST OK?
ERROR NUMBER
no
STORAGE yes
TEST OK? ERROR NUMBER
TEST
TEMPERATURE
yes
TEST
OPT. DETECTOR
no STORAGE
TEST OK?
ERROR NUMBER
no STORAGE
TEST OK? yes
ERROR NUMBER
TEST
NEG. PRESSURE HOLDING
yes
TEST
BLOOD SYSTEM
no STORAGE
TEST OK? ERROR NUMBER
no
STORAGE yes
TEST OK? ERROR NUMBER
TEST
yes POS. PRESSURE HOLDING
TEST
VEN. PRESSURE SYSTEM
no STORAGE
TEST OK?
ERROR NUMBER
no STORAGE
TEST OK? yes
ERROR NUMBER
TEST
UF FUNCTION
yes
TEST
AIR DETECTOR
no STORAGE
TEST OK?
ERROR NUMBER
no
STORAGE yes
TEST OK? ERROR NUMBER
TEST
CONDUCTIVITY
yes
TEST
DISPLAY
no STORAGE
TEST OK?
ERROR NUMBER
no STORAGE
TEST OK? yes
ERROR NUMBER
TEST DIASAFE PLUS /
HPU TEST
yes
TEST
ART. PRESSURE SYSTEM no
STORAGE
TEST OK? ERROR NUMBER
no
STORAGE yes
TEST OK? ERROR NUMBER
yes
no
RETURN
MODUL
E T1
START T1 TEST
no no no no no no
STORAGE STORAGE STORAGE STORAGE STORAGE STORAGE
ERROR NUMBER ERROR NUMBER ERROR NUMBER ERROR NUMBER ERROR NUMBER ERROR NUMBER
TEST TEST
VEN. PRESSURE SYSTEM TEMPERATURE
yes yes
TEST OK? TEST OK?
no no
STORAGE STORAGE
ERROR NUMBER ERROR NUMBER
T1 TEST no
no no no RETURN
UNSUCCESSFU
STORAGE STORAGE STORAGE
ERROR NUMBER ERROR NUMBER ERROR NUMBER yes
no yes
TEST TEST INCORRECT
POS. PRESSURE HOLDING Conductivity? CONDUCTIVITY TEST STEP
yes yes no
TEST OK? TEST OK? TEST OK? ERROR DISPLAY
no no yes
no no no
no no no
Navigation
Test Test description
X632/A26 HOT_RINSE
Power X639/
Supply A20
4008
X632/A10 H_REL_W X639/A12
X632/A9 EM_H_OFF
F X639/A17
X632/C25 V24_EN
X632/C26 V24B_EN
N
X632/B22 CI
LP 632
X632/A6 V26
6
CPU 2
X632/A6 V26
6
X632/A5 V24B
X632/A4 V24
4 X634R/A18 X634R/C22
X634L/C25
X634L/C12
X634L/A25
X631/A20 X631/A21
X1631/20a X1631/21a
LP 630 DATA BUS
L P1631
CPU 1 Mother-
board
V24B
V24
V26
LP 922
Display
board V24 V24B V26
Testgenerierung/Generation of Test
Rückmeldung/Acknowledgement
X632/A30 OD_OUT
X633L/C7
X633L/C8 OD_IN
X631/A20 X631/A21
X1631/20a X1631/21a
LP 630 DATA BUS
L P 1631
C PU 1 Mother-
board
X351/5 X351/7
LP 922 Pven
X351/10
Display
board
Testgenerierung/Generation of Test
Rückmeldung/Acknowledgement
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/A14 LP 634
X634L/A15
Input Output
board board
BPST_ART
X633L/ C13 /A13 / X634L/B14 /C14
/B15
X631/A20 X631/A21
X1631/20a X1631/21a
BPSST_A
LP 630 DATA BUS
L P 1631
Mother-
BPSST_V
CPU 1
board
X348/V1
X348/V3
X348/V6
X348a/1
X348a/3
X348a/6
X348a/2
X351/8
X351/6
LP 922 Pven
Display
board
Testgenerierung/Generation of Test
Rückmeldung/Acknowledgement
Test description Check the lower limit by verifying the venous zero point.
Check the upper limit by detuning the venous pressure unit in positive
direction
(the venous line clamp remains closed while the test is in progress).
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
X1631/20a X1631/21a
LP 630 DATA BUS
L P 1631
CPU 1 Mother-
board
X351/1 X351/2
PVEN
LP 922
Display
board
X351/4 X351/10
Testgenerierung/Generation of Test
Rückmeldung/Acknowledgement
Test description – Test the air detector by checking the alarm state.
– Turn off the venous line clamp in the air detector module.
X632/C10 CLP_CTL
LP 632
X632/C14 LDA2
CPU 2 X632/C13 LDA1
X632/C16 LDSA
X632/C21 V145
LP 633 LP 634
Input Output
board board
X1631/20a X1631/21a
LP 630 DATA BUS
L P1631
CPU 1 Mother-
board
X351/10 X351/14
PVEN
LP 922 X351/6
Display
board
X351/8
Testgenerierung/Generation of Test
Rückmeldung/Acknowledgement
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
X1631/20a X1631/21a
LP 630 DATA BUS
L P1631
CPU 1 Mother-
board
LP 922
Display
board
Testgenerierung/Generation of Test
Rückmeldung/Acknowledgement
Test description Test the arterial pressure unit by electronically detuning it in positive or
negative direction.
LP 632
CPU 2 X632/A17 PA_DET
X632/B27 X632/B28
LP 633 LP 634
Input Output
board board
X633L/B12 P_ART
X631/A20 X631/A21
X1631/20a X1631/21a
LP 630 DATA BUS
L P1631
Mother-
CPU 1
board
X348a/7 X348a/9
LP 922
Display
board
Testgenerierung/Generation of Test
Rückmeldung/Acknowledgement
TESTBATT
LP 632
CPU 2
X634R/C23 X639/A10
LP 633 LP 634
X632/B27 X632/B28 Input Output Power
board board Supply
4008
X633L/B21 X639/A2
X639/A3
X631/A20 X631/A21 X639/A4
X1631/20a X1631/21a
LP 630 DATA BUS
L P1631
Mother- U_ACCU
CPU 1
board
LP 922
Display
board
Testgenerierung/Generation of Test
Rückmeldung/Acknowledgement
Test description Test the blood leak detector by lowering the capacity of the transmitter
diode.
LP 632
CPU 2
X632/A25 BLL_DET
X632/B27 X632/B28
X633L/B27
LP 633 LP 634
Input X633L/B10 Output
board board
X633L/B9
X631/A20 X631/A21
X1631/20a X1631/21a
LP 630 DATA BUS
L P1631
Mother-
CPU 1
board
BLL_TEST
BLL
LP 922
Display
board
Testgenerierung/Generation of Test
Rückmeldung/Acknowledgement
Test description Test the upper alarm limit by electronically detuning the temperature
display in positive direction.
Figure
X632/A23 T_DETADJ
X633R/C21 X633L/B16
X634R/C24
X631/A20 X631/A21
X1631/20a X1631/21a
LP 630 DATA BUS
L P1631
CPU 1 Mother-
board
und Italienversion 1.00
Monokonzentrat
MON_NTC
X639/A20
NTC_BIB
LP 922
Power
Display Supply
board 4008
Testgenerierung/Generation of Test
Rückmeldung/Acknowledgement
Test description The actual value of the dialysate pressure transducer may change only
within certain limits in a defined time period.
X632/A19 ACKN_ASP
LP 632
X632/B22 CI
CPU 2
X632/C27 UF_P_CTL
X632/A29 P_DIAL
LP 633 LP 634
Input Output X634L/B10
board board
X633R/C28 X634R/A24
X631/A20 X631/A21
X1631/20a X1631/21a
LP 630 DATA BUS
L P1631
CPU 1 Mother-
board
UF_P_CTL
+P_DIAL
LP 922
Display
board
Testgenerierung/Generation of Test
Rückmeldung/Acknowledgement
X632/C26 V24B_EN
LP 632
X632/A4 V24
CPU 2 X632/A6 V26
X634R/C22
X634R/A18
X634R/A24
X632/C20 P_DETADJ
X634L/B10
X632/A29 P_DIAL
X633L/ X633R/
X632/B27 X632/B28 B6 A18
. X634L/ X634L/A6
LP 633 A25 LP 634 X634L/A8
X634L/A5
Input Output
X634L/A7
board board
. X634L/
C25
X634L/C22
X634L/A22
X633R/
C28
X634L/
X634L/
A-C23
A-C28
X631/A20 X631/A21
X1631/20a X1631/21a
LP 630 DATA BUS
L P1631
Mother-
CPU 1
board
V43
DEGAS+P2
AIR_SEP+
AIR_SEP-
+P_DIAL
UF_P1
V31
V35
V26
V24
LP 922
V31 V33
Display
board
P97
ASP
V26 V24
V35 V37
Testgenerierung/Generation of Test
Rückmeldung/Acknowledgement
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 / X 634R/
X632/B27 X632/B28 B6 C11 A22
LP 633 LP 634
Input Output
board board
X1631/20a X1631/21a
LP 630 DATA BUS
L P 1631
.
CPU 1
Mother-
board
.
UF_P2 (nur bei 4008 HDF)
UF_P1
+P_DIAL
LP 922
Display
board
Testgenerierung/Generation of Test
Rückmeldung/Acknowledgement
Test description Test the alarm limits by electronically detuning the conductivity either by
+5% or by –5%.
X632/A26 HOTRINSE
LP 632
CPU 2 X632/A21 COND_DET
X632/A22 COND_SIG
7b
LP 633 LP 634
X633R/A16
Input Output
board board
X633R/
C17
X633R/C27
X631/A20 X631/A21
X1631/20a X1631/21a
LP 630 DATA BUS
L P1631
CPU 1 Mother-
board
COND_C132
COND_BIB
COND_C1
LP 922
Display (bibag-LF-Zelle)
board
Testgenerierung/Generation of Test
Rückmeldung/Acknowledgement
Test description Volume test of the inner capillaries and pressure holding test.
X 632/B 5 V _DSA FE
X632/C 25 V 24_E N
X 632/C 26 V 24B_EN
L P632
CPU 2 X 632/A 6 V 26
X634R/A18
X634R/C22
X 632/A 29 P_DIA L
X633L/
X 632/B27 X 632/B28 B6
X 634L /A -C 28
L P 633 L P634
X 634L /C 5
I nput Output
X 634L /C 7
board
. X 634L /C 25
board
X 634L /A 7
.
X633R/
C 28
X634L/
X634L/
A-C23
A-C30
X631/A20 X631/A21
X1631/20a X1631/21a
L P630 DATA B US
L P1631
CPU 1 M other-
board
DEGAS+P1
V 112
FLOW+P1
+P_DI AL
V36
UF_P1
V35
V26
L P922
V 32
Display
board
V 26
V 35
V 35 V 36
Testgenerierung/Generation of Test
Rückmeldung/Acknowledgement
11.1.2.1 PSW (pressure switch) monitoring during free rinsing (only devices with CDS)
START
no V104 opens
PSW 104
Pressure decrease by
open
membrane pumps
yes
V102 opens
PSW 102 no Pressure decrease by
open membrane pumps
yes
Pressure build-up
V91/100/102 open PSW 102 no Error message
closed Rinse Failure F08 24 V is switched off.
System stopped
no
11.1.2.2 Rinse section test (check of V91, V99, V100) (only devices with CDS)
yes
V 102 is opened for 900 ms Pressure Message
reduction with membrane pump (for two PSW 102 no V99 Failure
balancing chamber switch-overs) open System stopped
yes
no
yes
yes Message
Pressure build-up PSW_102 PSW_102 no V130 Failure
V91/100/102 open for 900 ms V99/104 open System stopped
closed Concentrate and bicarbonate
pump stopped
yes Message
PSW 102 no V188 Failure
yes open System stopped
Pressure build-up PSW_102 V102/104
open for 900 ms V91/99/100 -closed
Pressure decreased with concentrate
pump
Normal mandatory rinse
sequence
11.1.2.3 Rinse section test (check of V91, V99, V100, V130) (only devices without CDS)
PSW 134 is used for the test evaluation. The following conditions must
be met for carrying out the rinse section test:
– The test is only carried out in mandatory rinse mode and during the
last 3 minutes.
– PCB LP 1631 (CPU 1): Array 2, DIP switch 7 ON
Mandatory rinse no
time ≤ 3 min
yes
Pressure decrease by Bic. pump Pressure build-up V91 open
(performed 5x) V100 -closed
Rinse Failure F15 Program Pressure switch no Rinse Failure F17 Program
Pressure switch no
stop closed stop
open
yes yes
yes yes
Pressure reduction via V100
by Conc. pump
(performed 8x) no
HPU -installed?
yes
Pressure build-up V91/100
open
Pressure switch no Rinse Failure F20 -
closed Program stop
yes
Pressure reduction via V99
The following conditions must be met for carrying out the V39 test:
– The test is only carried out in mandatory rinse mode and during the
last minute.
– PCB LP 632 (CPU 2): Array 2, DIP switch 5 OFF
Mandatory rinse
≤ 1 min
Wait for 10 s
Measure for 5 s:
Mean pressure value dav1
Open: V39
Wait for 5 s
Measure for 5 s:
Mean pressure value dav2
no
yes
Stroke volume 10 15 20 25 30 35 40 45 50
(ml)
Switching point 110 130 150 172 195 219 244 270 299
(mmHg) ±
7 mmHg
Warning
Do not change the position of the hex switches during operation.
Warning
The syringes classified as approved below have been successfully
tested with the device.
If syringes classified as not approved in the table below are used, it is
the responsibility of the responsible organization 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 hemodialysis device resulting from the use of non-
approved or unsuitable consumables or accessories.
0 20 ml BD / Fresenius approved
3 10 ml BD not approved
4 30 ml BD not approved
5 50 ml BD not approved
C not assigned –
D not assigned –
E not assigned –
F not assigned –
Air entering 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
bubble catcher). An essential task of the air detector is to monitor the
filling level in the venous drip chamber.
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 approximately 90 kHz, which are absorbed by a
receiving resonator. The amplitude of the signal received is dependent
on the medium between the converters. Its value is at its minimum with
the venous 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 to 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 causes the venous line 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
line clamp closes. The deaeration valve in the air detector module
opens, and the blood level rises. The blood pump runs at reduced
speed (100 ml/min). As long as the key is pressed, the venous line
clamp remains open. The deaeration valve in the air detector module
opens, the ventilation pump is running, and the blood level sinks. The
blood pump runs at the preselected speed.
The optical detector detects if there is blood or NaCl solution or air in the
venous return line downstream of the venous bubble catcher. In the
hemodialysis device, the hemodialysis phase is defined by presence of
a dark medium and the preparation phase by presence of a clear
medium.
V116
S8 P185
F63
V26
A V30
F76 CD110 S182
PT4
V41 P29
V31 V32 V33 V34 CD7
P97
V92 F114
V43
H54 PT3 PT109
S5 V39 S6
PT2
H88
H68
V189
H66 H89
H66a H66b H66c H88a H88b H88c
V35 V36 V37 V38 S9
H151 C A78
F210 85
H77 S115 V84 S115
P21
A65
H94 H95 B
V99
F148
S10 S12
F149 F74
H V100 H
90a 90b H205
V91 P22
121 F119 V117 S123
V102
P23 P25
S134
PT133
S138 S137
CD132
H136
H201 S202 S204 H203
V188 V130
H94 H95
F71 F72
As soon as the water inlet valve V41 opens, the water flows through the
pressure reducing valve A61 into the water inlet chamber H66a of the
heater block H66 and across the heat exchanger H77 into the heater
rod chamber H66b.
The concentrate pump P23 admixes the concentrate to the inflowing
water for each balancing chamber phase.
The vent tubing prevents pressure from building up in chambers H66b
and H66c. In HOT RINSE mode, the developing vapor can escape
through the vent tubing.
While it is rising, the fluid is warmed up to the preset temperature by the
heater H54. The heater is controlled by the temperature sensor PT2.
From chamber H66b, the dialysate flows into the chamber H66c. In this
chamber is the float switch S5, which controls the solenoid valve V41,
thus ensuring the correct fluid level.
The degassing pump P29 draws in the dialysate via the degassing
orifice H89. This generates a negative pressure of approximately
0.8 bars.
In the lines and the following degassing chamber H88a, the dialysate is
degassed to a level which is sufficient for hemodialysis.
Via the degassing pump P29, dialysate and released air are directed
tangentially into the primary air separator H88c, where air bubbles and
the airless dialysate are separated. The air accumulates at the top of the
chamber H88c and escapes into the atmosphere with the recirculation
flow via the loading pressure valve A65 and the chamber H66c.
Chamber H88c is provided with a separating disk (standard hydraulics
unit only) which prevents recirculation into the heater rod
chamber H66b when bicarbonate is added.
At the bottom of chamber H88c, the degassed dialysate is pressed out
and into the balancing chamber H68 by means of the loading pressure.
Together with the eight solenoid valves V31 to V38, the balancing
chamber H68 constitutes the balancing system. The balancing
chamber comprises two compartments, separated by an elastic
membrane each. So there are two chambers with four compartments:
– F1 and F2: Fresh solution
– A1 and A2: Used solution (waste)
When one of the chambers (A1 or A2) is filled with dialysate, the
solenoid valves are switched in groups of four. The valves are switched
based on electronic evaluation of the current rise pulse of the drive
motor of the flow pump P21; this pulse is created when the membrane
reaches the end position. 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 balancing chamber is switched parallel to the
first chamber. The second chamber is operated at an inverse sequence.
Each time the chamber is changed over (membrane end position), all
valves are closed for approximately 100 ms (dead time).
From the balancing chamber H68, the dialysate flows through the
conductivity cell CD7 with integrated temperature sensor PT3. The
measured conductivity values are indicated on the monitor in mS/cm,
referred to 25 °C.
The temperature sensor PT3 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 limit settings, the bypass valve V26 opens, and the
dialyzer inlet valve V24 is closed. The device is now in bypass mode.
The dialysate is discharged into the drain not via the dialyzer, but via the
secondary air separator H88b and the balancing chamber H68.
If the actual conductivity and temperature values of the dialysate are
within the set limits, the dialyzer inlet valve V24 opens. The bypass
valve V26 is closed. The dialysate flows to the dialyzer.
After the dialyzer, the dialysate which is now loaded with the urinary
excreted substances flows via the filter F73, the dialyzer outlet
valve V24b and the blood leak detector S8 into the secondary air
separator H88b. In the secondary air separator H88b are the pressure
transducer S9 and the level sensor S6.
The blood leak detector S8 generates an alarm in case of blood losses
of 0.5 ml per minute with a hematocrit of 0.25.
The signal of the pressure transducer S9 is evaluated together with the
venous return pressure and indicated on the monitor as TMP. The level
sensor S6 monitors the fluid level in the secondary air separator H88b.
The secondary air separator H88b ensures that no air can enter the
balancing chamber H68. Any presence of air bubbles in the balancing
chamber H68 would cause balancing errors.
The dialysate is pressed through the flow pump P21 into the balancing
chamber H68. As mentioned above, the balancing chamber valves are
reversed by the current rise pulses of the drive motor of the flow
pump P21. Using the speed of the flow pump P21, 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 A78 is used to limit the pressure of the flow pump P21
before the balancing chamber to approximately 2 bars.
After the balancing chamber H68, the dialysate flows though the outlet
valve V30, the heat exchanger H77 and the drain valve V87 into the
drain.
The recirculation valve V86 and the drain valve V87 recirculate fluid
during the hot rinsing and disinfection programs.
Standard program
1st cycle:
V30
H68
F1 A1 F2 A2
P21
2nd cycle:
V30
H68
F1 A1 F2 A2
P21
This system ensures that equal amounts of fluid enter and exit the
dialyzer. This results in an exact balancing of the dialysate and, in
conjunction with the UF pump P22, a controlled volumetric
ultrafiltration.
When the fluid level in the secondary air separator H88b has dropped
below the level sensor S6, this sensor activates the air separation
pump P97. If the fluid level has not reached the level sensor S6 within
a given time, the Fillprogram is started.
Note
In order to detect the fluid level, the level sensor S6 requires a fluid with
a certain minimum conductivity, which is definitely achieved in all
dialysis programs. Separation of air is only required for the dialysis
programs. In all other programs, the air separation pump P97 and the
fill valve V43 are force-actuated.
1st cycle:
V30
V43
H68
F1 A1 F2 A2
S6
V35 V36 V37 V38
S6
H88b
P21
S9
V84
2nd cycle:
V30
V43
H68
F1 A1 F2 A2
S6
V35 V36 V37 V38
S6
H88b
P21
S9
V84
If not enough air was separated and the fluid level is still below the level
sensor S6, the Fillprogram is activated. The fill valve V43 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 by chamber A2 via the dialyzer and
into the secondary air separator H88b.
2nd cycle:
Chamber F2 is filled. This forces the fluid from chamber A2 into
chamber A1. The fluid is then forced by chamber A1 via the dialyzer and
into the secondary air separator H88b.
Note
Repeated activation of the fill program during treatment indicates a
defect (leakage).
End of dialysis
Dialysis
PGM Program
R Rinse
R endl. Rinse endless
F Free rinsing
HR Hot rinse
C Cooling rinse
D Disinfection
D(F) Cleaning
Disinfectant is sucked in from the front
(concentrate suction tube)!
HDIS Hot disinfection
M Mandatory rinse
IHR Integrated hot rinse
The rinse chamber is emptied at the end of the set program for
approximately 1 min.
The time specifications are based on the factory setting. Shorter or
longer program times can be set at any time with the SETUP MENU
(see Chapter 5.1.3 on page 5-3).
Rinse
PGM 1: -R-
T/°C
37
33
t/min
Rinse chamber
Rinse evacuation
10 strokes each
Start End
T/°C
37
33
t/min
Rinse endless
Start End
(abortion of program)
Hot rinse
PGM 1: -F-HR-C-
T/°C
80
37
34,5
t/min
Heating Hot rinsing Cooling rinse Rinse chamber
Timing from 80 °C down to 34.5 °C evacuation
Rinsing clean 10 strokes each
PGM 2: -F-HR-
T/°C
80
37
t/min
Heating Hot rinsing Rinse chamber
Timing from 80 °C evacuation
Rinsing clean 10 strokes each
PGM 3: -IHR-
T/°C
80
t/min
Rinse chamber
Integrated hot rinsing evacuation
10 strokes each
Start End
PGM 3: -IHR-C-
T/°C
approx.
80
approx.
35
t/min
Rinse chamber
Heating Integrated hot rinsing Cooling rinse evacuation
10 strokes each
PGM 1: -F-D-M-
T/°C
37
33
t/min
Rinse chamber
Rinsing clean Prep.* Disinfection Mandatory Rinse evacuation
10 strokes each
3–10 min approx. 10–20 min (Setup) 15–30 min (Setup) approx. 1 min
(Setup) 1 min
Start End
PGM 2: -F-HDIS-M-
T/°C
80
37
34,5
t/min
Heating Rinse chamber
Hot disinfection Mandatory Rinse evacuation
Rinsing clean Prep.* 10 strokes each
approx. 6 min 10–20 min (Setup) 15–30 min (Setup) approx. 1 min
3–10 min approx. approx.
(Setup) 1 min 4 min
Start End
PGM 3: -F-D-M-HR-
T/°C
80
37
3–10 min approx. 10–20 min approx. 6 min 15–30 min (Setup) approx. 1 min
(Setup) 1 min (Setup)
Start 15–30 min approx. End
(Setup) 4 min
Prep.*: preparation phase:
Heater off.
Set the level of the float switch chamber below the lower switching point of the float switch
by 1 balancing chamber changeover and 4 UF pump strokes.
Aspiration of disinfectant for 50 UF-pump strokes.
PGM 4: -F-HDIS-M-HR-
T/°C
80
37
t/min
Heating Hot Heating Rinse chamber
disinfection Hot rinsing evacuation
Rinsing clean Prep.* Mandatory Rinse 10 strokes each
approx. 6 min 10–20 min approx. 6 min 15–30 min (Setup) approx. 1 min
(Setup)
3–10 min approx. approx. 15–30 min approx.
(Setup) 1 min 4 min (Setup) 4 min
Start End
PGM 5: -F-D(F)-M-
T/°C
37
33
t/min
Rinse chamber
Rinsing clean Prep.* Disinfection Mandatory Rinse evacuation
10 strokes each
3–10 min approx. 10–20 min (Setup) 15–30 min (Setup) approx. 1 min
(Setup) 1 min
Start End
8A-2013
interface
+24V_SW 4008 Battery
11-43
11-44
Power supply board
Fresenius Medical Care – 4008 power
Fuse board
Chapter 11: Functional description
Additional power
Heater fuse
11.2.2 Voltage supply block diagram
SM-EN
8A-2013
Power Supply 4008
RAM
RS232 CPU
RS232
11.2.3 Monitor block diagram
RAM
RS232 CPU
SM-EN
Motherboard LP 630
U-ACCU
24V_US
Adress-/Databus
8A-2013
MDC-II-board TFT-Display
Display board
LP 922 ROM
RS232
Video
RAM DRAM
11-45
Chapter 11: Functional description
HYDRAULIK / HYDRAULICS
LP 941 WTR / HPU
X B2 X C1 X A7 X1
bibag®-Konnektor / X S1 P-Dial 2
bibag® connector Pumpen / pumps Ventile / valves Sensoren / sensors CAN
X S2 N.C.
X 16
N.C. X R1 OCM_NTC4 X2 NTC2 X S3 N.C.
LP 1135 N.C.
Conc. P. Bic. P.
X 15 OCM_LF1 10 X3 NTC3 X S4 N.C.
CO1 BI1
X 14 NTC109 X5 FL-Switch X 17 X S5 Niveau Konz.
Kabelbaum / cable harness X 13 LF-Bibag 132 X6 Niveau 6 RJ-45 X S6 NTC308
X A5 X A1 X A2 X 12 Bibag NTC133 X7 LF 7 X S7 LF309
X 11 Bibag (LP1628) X8 P-Dial 1 (9) X R3 Bibag SW
X A6 X A4 X A3
X 10 ZKV PSW X9 Reedk. 10 X B1 X R2 V89 Sens.
BLD
GEHÄUSE / EBM
HOUSING
X_CAN_WTR
MONITOR
LP 1147
BPM (Option)
X2 LP 1131
Ampel
Traffic X1
LP 636 X1131
Extern I/O
LAN
X BPM X CR X CAN
LP 630
Motherboard
Diagnose /
Diagnosis
XACDA
X 636 X 637B
X HDF
X 633L
X 634L
X 632
LP 632
X ACCU
Akkumulator / X 637C
CPU 2
Accumulator X CAN
X PWR
Netzteil 4008 /
Power supply 4008 LP 633 LP 634
Input Output
board board
X RS
X 634R
X 633R
X 639A
X 631
LP 1631
X 63Z
XB1 CPU 1
XF1 XC2
X 635
Kurzschlussteil / LP 922 X5
Shunt interlock Display Board
Monitor
PCB LP 1631
Operating system (OS)
CPU 1
Hydraulics unit
PCB LP 1628
Distribution board
CAN
PCB LP 941
Hydraulic processing unit
HPU
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 Potenzialausgleich / Ground
1
2 8 Klemme u lamp closed = L
LP 248 X160 ODSA = H
3 7
4 6 LDA2 = H
Potenzialausgleich
Ground
11.2.9 PCB LP 624 Pump control, arterial blood pump / Single-Needle blood pump
(option)
C8
C9
1
2
C10
C11
C6
C7
J5
C4
C5
C15
C17
C13 C16
Fig.: PCB LP 630 layout O
C18 C14
C12
FU6
FU5
FU4
32
32
32
C
C
C
B
A
B
A
B
A
P
P
2
1
XACDA 1
X637B
O
O
O
1 2
X636 2
N
N
N
Chapter 11: Functional description
3 4 7 8 J3
J2
M
1 2 5 6
L
L
1
Jumpers:
Codierbrücken:
XHDF 2
K
K
Standard (4008): J2=7-8 J3=1-2
J
J
C19
4008-ADS: J2=5-6 J3=2-3
I
I
11.2.10 PCB LP 630 Motherboard
1
H
H
X632
X633L
X634L
G
G
1
C20
X637C 2
XACCU
F
XPWR
E
E
B5 A5
D
D
Connection cable C21 B4 A4
Anschlußkabel
C
C
C
C24 2
-soldered on C22 B2 A2 1 XCAN
B
eingelötet
B
B
C25
C23 B1 A1
A
A
C26
R3
R2
R1
1
1
1
FU8
DR1
FU9
A
A
A
C
C
C
32
C
2
32
32
32
B
A
P
XRS
P
1
C3
C2
C1
O
J1
N
2
M
M
J4
1
2
L
L
L
K
K
K
K
J
J
J
J
I
I
I
R4
H
H
H
X63Z
X633R
X634R
X631
G
G
G
X639A
G
1
F
F
F
F
XB1 2
E
E
E
D
D
C
B
B
2 1
1 XF1 XC2 2
A
1
1
1
FU2
FU3
FU7
X635
FU1
1
SM-EN
8A-2013
Crystal-controlled 512 kByte 8 kByte 32 kByte
Reference oscillator EPROM NOVRAM SRAM U-REF
voltage 10 MHz (FLASH) 5V
5V
U-REF 5V
inputs
ANALOG
Fig.: PCB LP 632 block diagram (SMT)
C515C
Micro-
Control bus
controller 8-
16-
DIGITAL DIGITAL
PORT
(DIRECT) Adress bus (BUFFER)
ADRESSES
SM-EN
2x8 8-
DIP Data bus POWER
SWITCH outputs
DATA
(BUFFER) (BUFFER)
8A-2013
Tx
serial interface
24- Rx 8x
DIGITAL Status
inputs LED's
(BUFFER) (BUFFER)
8-
DIGITAL
outputs
PORT
(DIRECT)
Control bus
Data bus
Chapter 11: Functional description
11-55
Chapter 11: Functional description
analog digital
BUFFER 6
BUFFER 0
P_V102 CSS_REED FL_SWITCH_+5V
5V/12V
SP ARE CI
P_VEN SP ARE ABG_BYP
SP ARE ABG_ON
BPR_VEN SP ARE MF ABG_ALARM
ADC 0
BPR_AR T
V43
VEN_BPR_SET V26
V24B
BUFFER 7
BUFFER 1
AR T_BPR_SET V24
LD_SERIAL
UF_P1
Uref LDA2
SUB_W_P
SP ARE
U_ACCU REED_BIC
BIBAG
P_V104 REED_RINSE
BUFFER 2
BIBAG_C
24V_EM PSW_V102
PSW_V104
P_AR T PWR_OFF
ADC 1
HEP_ON
BLL_DIM
SP ARE
BLL/BLL_OLD SW_ON_OFF
PWR_F AIL
COND_SIGNAL BUFFER 3 SHUNT_OUTP
SHUNT_INP
Uref SHUNT
SER V_EN
LEV_SIGNAL
SP ARE SN
ADKS
TEMP_DIAL2 BPSB_AR T
BUFFER 4
BPUS_AR T
COND_SIGNAL2 BPSB_VEN
BPUS_VEN
BIBAG_TEMP HEP_ALARM
ADC 2
BIB_LEVEL
BIBAG_COND
EXT_ALARM
SP ARE SER VICE_MODE
LEVEL UP
BUFFER 5
Microprocessor Interface
DATEN–BUS
STEUER–BUS
ADR–BUS
CPU 1
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-
controller
EN4
Latch BIC_P
&
EN_CPU2
EN6 V24
& V24 V 1
V24B V24b V102
Steuerbus / Latch
Adress- V26 V126
Controlbus V87 V130
decodier-
Adressbus / ung /
Adressbus Adress-
decoding EN7
V30 V86
Latch V41 V
V43 V104
Datenbus / Bus V84
Data bus treiber /
Bus
driver
EN8
SN_EN HDF_LOG1
Latch SNST PROG_LOG2
CPU_OFF VENT_V AL VE
V_ADS
EN9
CLR_ALARM CPU_A U
HOT_RINSE HEA T_OFF
Latch
TEST_BA TT STAFF_CALL
EN10
BPST_ART BPSST_VEN
BPSST_ART HDF_SEL
Latch
CLAMP_CTRL BPST_VEN
Latch GAL
Micro-
controller
Oszillator /
Oscillator
EN1 1
Zähler /
Latch FLOW_P
Counter
D/ A DEGAS_P
TEMP_SET DAC_BLL
DAC_DIM DAC_
TEMP_AD DAC_P_ZE
U_ref STEUER_EP BIBAG_TEMP_A
STEUER_FP
EN12
V_Z V1
V_Z V2
Latch
V
FREE_OUTP
R114 BR1
MP8 MP7 MP6 MP5 MP4 MP3 MP2 MP1 1
C66 C65
IC1
IC2
IC3
IC5
P1
R17
R19
IC16
R14 R15
R21
C1 C2 C3 R3 C5 R4
DIP-Switch S1
O
N
R23
S1
1
2
3
4
1 2 3 4
R150
R60
IC15
C76
Fig.: PCB LP 634 layout Q
C17
NTC1
D11
Q1
ON OFF OFF OFF ACUTE 4008
C19
C22
R38
9001
R12
C14
C29
C58
R11 R149
OFF ON OFF OFF STANDARD 4008
C9
R82 R65
IC9
R25 R44 R62
R125
IC25
R46 R61 R127
ON ON OFF OFF STANDARD ART (SW1.10)
C72
C67
R52
Chapter 11: Functional description
C68 C31
C47
C45
R51
R126
C71 C15 IC32 R33 IC36 C25 OFF OFF ON OFF ACUTE ART (SW1.10)
+
C38
IC26
R42R49
R111
C32
D5 R50
C70
D51
R59
IC18
R54 R75 D50 C20 D13
C18
R47
IC42
IC40
R143R147R146 R145
C51
C44
IC30 C40 C37
R144
R53
C59
C43
C64 D12 R120 R45 R39
R40
C99
R119 R121 R16 R24R22 C35
C21
9002
R20
R55
R136
C95
IC8 IC27
R91
R37
R58
1
R31
Q2
9004
IC31
IC35
DR5
R115 R28 R35 R137
D36 R18
IC51
IC39
C23
C98
IC12
R117
R128
R116
9005
C53
R13
R10
C46 R99 C39 D6 R56
+
C10 R2 R34
9011 C34 C63 R131 C73 R36 C12
IC17
C69
C55 C13
IC4
IC10
IC54
IC14
R43 R48
IC29
C57
IC55
C54
C97
IC38 C8 R7 C4 R1
C36
C41
R66
R64
D32
R69
R72
R71
C42
R107
DR1 DR4 R68 R67 R63 R122 R142
R141
IC7
R41
IC13
R140
IC34
1
IC41
R102 C33 R139
C11
IC50 R138
C48
D49
D48
R94
R93
D31
+
R9
C7 R108 C74 C75
R6
T1
R80
R86
R89
R100 R97 R90 C49 R118 R8 C96 C62
R92
R74
+ C60 D34
+ C61 D35
IC6
IC11
IC52
IC21
D19
T3
C94
9002
R164
IC46
R161
C6
R130
DR3
R104
R101
9003
R5
R113 R112
R178
R175
R98
R190
R191
R189
R187
R188
R186
R184
R185
R124
R155
R77
R76
D52
9005
R174
R153
T4
IC20
R129
IC43
IC44
R163
R162
T16 T15 T13 T12 T6 T5
D4
D7
T9
24
C86
R177
13
R169
D41
D40
D42
D29
9012 25 12
R135
C93 Q3
R105
R106
R109
D45 D28 D10 D2 D15 D22 IC45 R179 C92 IC33
C87
D16
1 C89 R170 36 1
R132
C84
C90
R166
R165
D21
48
37
T8
C85
IC28
D9
D8
IC37 R160
T19
D24
D30
D43
D27
D33
D23
R154 R168
R79
IC19
D26
R83 R81
R73
R32
C27
C26
R30
R29
R95
C79 C82
C80
C83
+ C78 R158
R70 C28 R134 R133
C91
C88 R159
D20
D18
R110 R78
C50
R181
R180
C C
R183
32 B 1 32 R182 1
A A
X634L X634R
SM-EN
8A-2013
Chapter 11: Functional description
S1
ST6 1
X1131
P1
2
1
BR1
1 J1
C20
ST5
T1 C21
R1
R3 C1
IC1
C14
C15
ST4
C16
C17
C18
C11
C10
ST3
1
ST8
C8
C7
C5
C6
ST2
D8
1
RL2
ST7
ST1
1
2
D5
RL1
D6
D2
R11
R9
D7
X636
C31
T2 T3
C27
C32
R8
R10
D4
C29 C26
IC2
R12
C28
D3
R24
T1
R15
T2
R16 R25
LS1
D4
R22 D3
D5
R6 LD14 LD25
RN2 RN4 RN3
R7
T13
LD1
R8
CI28
CI5
CI11
T17
T16 T14
LD8
D2 LD22
IC12
R29
X4
R26 R30
RN6
R32
LD2
T3
R31
T5
CI3
T8 T9 R28
R10
R17
R11
T4
R18
R12 R40
R19
T10
T7
CI29
IC3 R20
T6
T11
R13 R21 CI23
R14 T12
IC29
CI13
CI14
CI24
LD23
IC14
T22
LD3
IC24
IC1
LD9
LD18
IC4
IC15
RN7
IC30
R41
IC5
IC25
IC31
LD24
LD10
LD19
IC16
IC26
IC32
IC6
CI6 C3 C1
R58
R57
C15 R4 1
48
R5
IC10
IC17
IC21
T19 T18
R62
XA2
IC2
XB2
IC13
R64
C16
R56
LD4 C9 R61
C4 CI10
R63
C14
CI2
R43
C13
LD16
Q1
CI7
R42 RN9
IC7 C2
LD21 LD27
IC8
1
IC34
48
RN5
R39
LD11
D1
CI8
LD5
R2 RN8 IC36 IC33
T21
LD12
RN1
R54
R53
R52
R51
R55
R1 R3
T20
R34 IC20
CI19 X2
D6
R60
D7
C6
C5
R59
D8
R45
D9
R44
F1
X5 RN10
IC22
LD6
C12
C8
C7
CI1
R46
R47 X1
D11
D10
R48 C11
R49
IC9
R50
CI9
LD13
LD7
Fig.: PCB LP 922 layout K
11.2.16 PCB LP 922 Display board
Chapter 11: Functional description
Chapter 11: Functional description
C16
ST2
R28
R1
D3
D7
D8
1
Fig.: PCB LP 950 layout M
R49
R52
T1
R48
R44
R5
R17 R31 R6
R43
C15
ZD2
R12
R46
DR12
C17 C18
C9
2
1
DR23 R16 R15 R47
C26
C32 R34
R19
R53
R20
D1 DR21
C1
R30 DR2 DR19
R4
C8
C19
R29 T4 T6 T8 T10
R8
DR18
R11
R21
R23
IC5 C10
R9
Q1
C3
DR17
R33
R32
C47
C2
C21 DR20 IC1 IC8 IC13
R63
C41
R45
R50
C48 DR30
IC12
R14
T3 T5 T7 T9
IC14
DR31 IC2
C31 C28
D2 C33
C5
ST4
D11
C49
IC17
R42
DR14
C7
R62 R41
R7
DR3
R13
R10
R22
IC4
DR25 C6 C12 C13 C14
C20 DR28 DR29
C22
DR8
DR9
DR1 DR27
C11
C27 2 DR24 T12
C24 ST1 DR26
1 DR33
DR32 SW1 IC11
1
IC3
R27
R58
C29
1
R3
C34
1
Q2
C23
R24
ST6
DR10
C30
DR11
DR34
DR15
DR16
DR6
DR5
DR7
DR4
C45 C43 C46 C42
SM-EN
8A-2013
Ersatzteilnr. (mit Controller u. SW) für Endgeräte:
Spareparts (with Controller a. SW) for Machines:
M47254 4008E/B/H/S/ARrTplus/Art/Prometheus
M46988 4008S V10
M46169 MFT
Chapter 11: Functional description
11-65
Chapter 11: Functional description
D28
X1
R7
R6
1
D17
D41
D29
D40
D16
R10
R11
D15 D39
D27
R14
R15
D14 D26
D38
R3
R5
D11
R9
R8
D9 D21 D33
D8 D20 D32
D7 D19 D31
D30
D6
D18
C8 R26 C50
30
20
C3 R25
IC17
1
IC4
C1
R111
C6
4
14
C19
5
13
C33
IC7
Q2
IC1
C48
C49
R32
C5
C51 C25
60 41
11 1
61 40
12 44
C7
IC16
C24
IC5
IC3
22 34
C22
R112
23 33
80 21
Q1
1 20 C4
R101 R45
C10
R43 R31
C23 1
C9 D11 X3
C55 2
R3
R30
R8 R20 R2 T2
T3 C56
R39
C35
R40 IC2
R13
R42
R9 R38 R37
R27
T1
IC12 R23
C14
C41
R41
F4
R48
C26
C47
IC19
D4
C27 R7
P1
C43
R10
C58 IC15
1
C17
T6
C28
C40
R49
L3
C31
R6 R5 R35
T7
C15
IC13 R28
D7
R19
R15
R33
D3 R47
C59
C44
IC9 D2
C64
IC11
C53
R36
V2
R16
C32 R17
1
C57 R29
F2
R34 C20
C39 T4 T5
L4
C37
C38
C42
IC6
C46
D8
L2
IC14
C13
V1
R18
C30
C16
1
IC8
IC10
1 D1 D5
R46
L1
C45
C62
C54
C63
C60
F3
F1
C36 1 1
X2 X1 2
C61
2
Fig.: PCB LP 1147 layout C
11.2.20 PCB LP 1147 BPM (optional)
Chapter 11: Functional description
Chapter 11: Functional description
DR2
C12
X1
C13
R3
R1 R5
1
2
R2
T5
R6
C1 R22
D2 T9
R36
R40
R10
R34
R37
R14
R41
X_CARD IC4
R35
R39
C16
R38
2
1
R16 1 X_LD
2 R14
X_BP_ART R15
1
R13
X2
R12 T3 R28
T4 T1 T2 T5 T6 2
R34
R40
R36
R42
R35
R41
R43
R37
R44
R38
R45
R39
R47
R48
R46
R11 T8 R25 R26 T7 X_HEP R30
R9 R10 R27 1 R32
R4 R20 R31
2
1
R29
R8 R24
R3 R19
R6 R22
R2 R18 2
X_BP_SN
X1
R7 R23
SM-EN
11.2.22 PCB LP 1627 Display, EBM SN (optional)
LD7
8A-2013
LD5 LD4 LD2
11-69
Chapter 11: Functional description
2 +24V_EM 2
X_CAN_MON
1 1
PWR_GND X_BPM_MON
R1 R2 MP2 C2
DR1 R14
2
1
R15
R9
MP1 R16
R8
X_CAN_WTR
R11
T2
R12
2 R13
R3
T1
1 R7
R6
X_CAN2
C10
IC4
MP3 MP4
C9
C8
C3
1
2
C7
C5
IC3
C4
2 C6
X_BPM
1
X_CAN3
C1
IC2 IC1
1 1 1
X_WTR X_S21/47 XS
LD2
LD1
2 2
R15
DP1
R16
R14
R13
DP2
DP3
X_HEP
2
1
1 X_LD
LD5
LD6
R46
R48
R47
DP7
R39
R45
R38
R44
R37
DP8
R43
R41
R35
R42
R36
DP9
R40
R34
X_BP_ART
2
1
LD7
R11
R4
R8
R3
R6
R2
R7
R5
R1
T3
R10
T2
R9
T1
T4
R12
2 MByte 32 kByte
ROM NOVRAM
Digital
I/O
Digital
I/O
DIP switch
array 2
Digital
I/O
SD card Digital
I/O
DIP switch
array 3
LEDs
D1
D2
D3
D4
D5
D6
D7
D8
13 14
S1 S2 S3
O
N
N
12
1
2
3
4
5
6
7
8
1
2
3
4
5
6
7
8
1
2
3
4
5
6
7
8
R101
R104
R105
R106
R107
R108
R102
R103
R100
R110
R112
R114
R86
R90
R92
R94
R96
R98
R88
R84
IC20
C54
R111
R115
R87
R89
R91
R93
R95
R97
R85
R99
R109
R113
MP14 X2
C53 10
BAH1 9 1 2 3 4 5 6 7 8 11
2
IC19
R78
X_JTAG
R79
R81
R82
D12 1
R67
C51C52
R76
R77
C49
R83
R65
R69
R70
R71
R72
R73
R36
R75
C48
R74
C50
C81
IC16
R159
IC17
IC3
C80
R30
R31
C56
1
X_LAN
R142
C73
DR4
R143
8
R141 C72
R138
R137
R136
R151
R152
12
1
C31
C37-1
105
R139 IC21
156
C71
R57 24 37
R56
36
IC12
C69 +
C67 C75
R63
C68
C66
T1 C39
D13
R158
R135
R60
R62
IC14
C23
C20-1 R119
R153
R162 R125
R127
R48
C17
C33
C32
R122
R124
R126
R118
C18
208 53
C63
1 52
IC8 R165
C61
C59
R46
R47
R45 R163 Q1
C12 R50
R29
X_USB
DR6
C57
IC7
C58
C15
C14
C16
C13
R43
R42
1
IC5
IC6
IC4
R41
IC2 R34
R33
C65
C21
R32
C11
R27
C10
R25
DR8
DR7
R26
R24
C9
C19
J1
1 4 J1
DR2 DR1
R80
R18
R17
R14
R13
R19
R15
R1
R3
C6
R5
C4 +
R6
R20
DR3
C2 +
D9
C5
C3
DR5
R21
R11
R10
C1
R7
R9
R12
R16
R2
R4
R8
C IC1
32 B 1
A
= Insulated by hot-melt
mit Heißklebepunkt spot gluing
isoliert
Function Jumper J1
Activate serial communication between heparin pump and PCB LP 1631. closed closed
12 Appendix
Chapter without content