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Fresenius MultiFiltrate - Service Manual

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0% found this document useful (0 votes)
1K views150 pages

Fresenius MultiFiltrate - Service Manual

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 150

multiFiltrate

Service Manual
Technical Manual
Edition: 6/03.07

Part no. M28 003 1


Table of Contents

1 Important Information
1.1 Organization of the Technical Manual ..................................................................................... 1-1
1.2 How to Use the Technical Manual............................................................................................ 1-2
1.3 Precautions for Working on the System ................................................................................. 1-3
1.4 Addresses .................................................................................................................................. 1-4

2 Functional Description
2.1 Extracorporeal Circuit............................................................................................................... 2-1
2.1.1 Pumps ......................................................................................................................................... 2-1
2.1.2 Heaters ........................................................................................................................................ 2-2
2.1.3 Pressure Transducer ................................................................................................................... 2-2
2.1.4 Air Detector and Venous Clamp .................................................................................................. 2-2
2.1.5 Optical Detector (Non-Opaque/Opaque Fluid Detector).............................................................. 2-3
2.1.6 Blood Leak Detector .................................................................................................................... 2-3
2.1.7 Heparin Pump.............................................................................................................................. 2-3
2.2 Weighing Units .......................................................................................................................... 2-3
2.3 Ci-Ca Module (Option)............................................................................................................... 2-4
2.4 Functional Test (T1 Test) and Error Messages....................................................................... 2-4
2.4.1 Battery Test, Part 1...................................................................................................................... 2-5
2.4.2 Scales Test.................................................................................................................................. 2-5
2.4.3 Pump Test ................................................................................................................................... 2-6
2.4.4 Pressure Transducer ................................................................................................................... 2-8
2.4.5 Optical Detector........................................................................................................................... 2-9
2.4.6 Air Detector................................................................................................................................ 2-10
2.4.7 Blood Leak Detector .................................................................................................................. 2-11
2.4.8 Heater ........................................................................................................................................ 2-12
2.4.9 Battery Test, Part 2.................................................................................................................... 2-15
2.4.10 Audible Alarm ............................................................................................................................ 2-16
2.4.11 Heparin Pump............................................................................................................................ 2-17
2.4.12 multiDataLink ............................................................................................................................. 2-18
2.4.13 Ci-Ca Module (Option)............................................................................................................... 2-18
2.5 Error Messages........................................................................................................................ 2-20
2.5.1 Alarm Messages ........................................................................................................................ 2-20
2.5.2 Warning Messages.................................................................................................................... 2-22
2.5.3 Fatal Errors................................................................................................................................ 2-30
2.5.4 Error Codes of “Scales” Lo-Level Routines ............................................................................... 2-33
2.5.5 Error Codes of “Pressures” Lo-Level Routines.......................................................................... 2-35
2.5.6 Error Codes of “Heparin Pump” Lo-Level Routines................................................................... 2-36
2.5.7 Error Codes of “Pumps” Lo-Level Routines............................................................................... 2-37
2.6 Overview of Display Identification Numbers ........................................................................ 2-37

Fresenius Medical Care multiFiltrate TM 6/03.07 0-1


3 Installation
3.1 Preface........................................................................................................................................ 3-1
3.2 Important Information on Initial Start-Up ................................................................................ 3-2
3.3 Initial Start-Up Report multiFiltrate .......................................................................................... 3-3
3.4 Explanations on the Initial Start-Up Report ............................................................................ 3-8
3.5 Installing the Ci-Ca Module (Option)...................................................................................... 3-16

4 TSC / TMC / Maintenance


4.1 Important Information Regarding the Procedure ................................................................... 4-1
4.2 TSC / MA Report multiFiltrate ................................................................................................... 4-2
4.3 multiFiltrate TSC Report ........................................................................................................... 4-8
4.4 Explanations on the TSC / MA Report ................................................................................... 4-12

5 Adjustment Instructions and Tests


5.1 Service Tools ............................................................................................................................. 5-1
5.2 Service Program ........................................................................................................................ 5-2
5.2.1 Start ............................................................................................................................................. 5-2
5.2.2 Selecting the Language ............................................................................................................... 5-3
5.2.3 System Messages ....................................................................................................................... 5-3
5.2.4 Deactivating and Activating the Heparin Pump ........................................................................... 5-3
5.2.5 Filtrate Bag Monitoring Limit ........................................................................................................ 5-4
5.2.6 Dialysate Tubing Arrangement .................................................................................................... 5-4
5.2.7 Option MultiDataLink (mDL) ........................................................................................................ 5-5
5.2.8 Taring and Calibrating the Scales................................................................................................ 5-7
5.2.9 Calibrating the Pressures ............................................................................................................ 5-8
5.2.10 Calibrating the Blood Leak Detector .......................................................................................... 5-10
5.2.11 Verifying the System Values...................................................................................................... 5-11
5.2.12 Events Memory.......................................................................................................................... 5-13
5.2.13 Program Treatment Modes........................................................................................................ 5-15
5.2.14 Programming the Ci-Ca Data (Option) ...................................................................................... 5-16
5.3 Extracorporeal Components .................................................................................................. 5-17
5.3.1 Tightness of the Venous Occlusion Clamp................................................................................ 5-17
5.3.2 Checking the Pressure Transducers ......................................................................................... 5-17
5.3.3 Venous Pressure Transducer (P.C.B. LP 450-3)....................................................................... 5-18
5.3.4 Air Detector (P.C.B. LP 450-3) .................................................................................................. 5-20
5.3.5 Optical Detector Sensing Opaque / Non-Opaque Fluid (P.C.B. LP 450-3) ............................... 5-21
5.3.6 Arterial / Filtrate / PHF Pressure Transducers (P.C.B. LP 343-1) ............................................. 5-21
5.3.7 Blood Leak Detector .................................................................................................................. 5-22
5.3.8 Setting the Heparin Pump.......................................................................................................... 5-23
5.4 Programming the Processors ................................................................................................ 5-25
5.4.1 Display Processor (DP) ............................................................................................................. 5-26
5.4.2 Operating and Safety Processors (OP and SP) ........................................................................ 5-26
5.4.3 Interchangeability of Safety and Operating Processor .............................................................. 5-30
5.5 Ci-Ca Module (Option)............................................................................................................. 5-31

0-2 Fresenius Medical Care multiFiltrate TM 6/03.07


5.5.1 Preparing the Functional Test ................................................................................................... 5-31
5.5.2 Functional Test of the Drip Counter........................................................................................... 5-32
5.5.3 Functional Test of the Hall Sensor ............................................................................................ 5-32
5.5.4 Functional Test of the Insertion Switch...................................................................................... 5-32
5.5.5 Functional Test of the Line Occlusion ....................................................................................... 5-33

6 PC Service Software MFT


6.1 Organization of the Quick Guide.............................................................................................. 6-1
6.2 General Information .................................................................................................................. 6-1
6.3 Preparation................................................................................................................................. 6-1
6.3.1 System Requirements ................................................................................................................. 6-1
6.3.2 Software Installation .................................................................................................................... 6-2
6.3.3 Hardware Installation ................................................................................................................... 6-3
6.3.4 ServiceCard Description.............................................................................................................. 6-3
6.3.5 Starting the Software ................................................................................................................... 6-3

7 Block Diagrams and Component Layouts


7.1 Block Diagram ........................................................................................................................... 7-2
7.2 AC Wiring ................................................................................................................................... 7-3
7.3 P.C.B. LP 122 Heater Control ................................................................................................... 7-4
7.3.1 Block Diagram ............................................................................................................................. 7-4
7.3.2 Description................................................................................................................................... 7-4
7.3.3 Component Layout ...................................................................................................................... 7-5
7.4 P.C.B. LP 123 Pump Control..................................................................................................... 7-6
7.4.1 Description................................................................................................................................... 7-6
7.4.2 Component Layout ...................................................................................................................... 7-7
7.5 P.C.B. LP 124 Motherboard ...................................................................................................... 7-8
7.5.1 Description................................................................................................................................... 7-8
7.5.2 Component Layout ...................................................................................................................... 7-9
7.6 P.C.B. LP 125 Blood Leak Detector ....................................................................................... 7-10
7.6.1 Component Layout .................................................................................................................... 7-10
7.7 P.C.B. LP 127 Scales Board.................................................................................................... 7-11
7.7.1 Description................................................................................................................................. 7-11
7.7.2 Component Layout .................................................................................................................... 7-11
7.8 P.C.B. LP 128, Power Supply Unit.......................................................................................... 7-12
7.8.1 Block Diagram ........................................................................................................................... 7-12
7.8.2 Description................................................................................................................................. 7-12
7.8.3 Component Layout .................................................................................................................... 7-13
7.9 P.C.B. LP 129 User Interface .................................................................................................. 7-14
7.9.1 Component Layout .................................................................................................................... 7-14
7.10 P.C.B. LP 244 Operating and Safety Processors.................................................................. 7-15
7.10.1 Block Diagram ........................................................................................................................... 7-15
7.10.2 Jumper Description.................................................................................................................... 7-15
7.10.3 Component Layout .................................................................................................................... 7-17

Fresenius Medical Care multiFiltrate TM 6/03.07 0-3


7.11 P.C.B LP 343-4 Pressure Transducer .................................................................................... 7-18
7.11.1 Component Layout .................................................................................................................... 7-18
7.12 P.C.B. LP 450-3 multiFiltrate Air Detector Control ............................................................... 7-19
7.12.1 Component Layout .................................................................................................................... 7-19
7.13 P.C.B. LP 950, Control Board (Heparin Pump)...................................................................... 7-20
7.13.1 Component Layout .................................................................................................................... 7-20
7.14 Ci-Ca Module............................................................................................................................ 7-21
7.14.1 Block Diagram ........................................................................................................................... 7-21
7.14.2 Component Layout (P.C.B. LP MS 0407).................................................................................. 7-22

0-4 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 1: Important Information

1 Important Information

1.1 Organization of the Technical Manual

Page identification Page number 1-3 is to be interpreted as: Chapter 1, page 3.

Editorial information The current edition of this Technical Manual is


6/03.07 = 5th edition, September 2006
In case of updates, the chapters concerned will be replaced.
Refer to the table below to verify that the Technical Manual is up-to-
date.

Chapter Current version


1 6/03.07
2 6/03.07
3 6/03.07
4 6/03.07
5 6/03.07
6 6/03.07
7 6/03.07

Changes Manual changes will be released as new editions and supplements. In


general - subject to change without notice.

Fresenius Medical Care multiFiltrate TM 6/03.07 1-1


Chapter 1: Important Information

1.2 How to Use the Technical Manual

Purpose This Technical Manual 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 Technical Manual,
however, does not replace the training courses offered by the
manufacturer.

Requirements Knowledge of the current Operating Instructions for the respective


system.
Background experience in mechanics, electrical and medical
engineering.

Specifications For the specifications of the respective system, refer to the current
Operating Instructions.

Circuit diagrams and The identification on the PCB permits the operator/technician to verify if
component layouts the circuit diagram/component layout matches the PCB actually
installed in the system.

Explanation of the Note


and Caution symbols used

Note
Informs the operator that in case of a failure to follow the steps as
described, a specific function will be executed incorrectly or will not be
executed at all, or will not produce the desired effect.

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

1-2 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 1: Important Information

1.3 Precautions for Working on the System

Authorized persons Assembly, extensions, adjustments, modifications or repairs may only


be carried out by the manufacturer or persons authorized by him.

Test equipment and The activities described in the Technical Manual require the availability
accessories of the necessary technical test equipment and accessories.

Precautions When working on the open system, the following precautions must be
respected:
– Protect the components against ingress of fluids.
– Do not touch live parts.
– All plugs, connections and components may only be disconnected or
connected if de-energized.

ESD precautions When repairing and when replacing spare parts, observe the applicable
ESD precautions (e.g. EN 100 015-1).

Fresenius Medical Care multiFiltrate TM 6/03.07 1-3


Chapter 1: Important Information

1.4 Addresses

Please address any inquiries to:

Manufacturer Fresenius Medical Care AG & Co. KGaA


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

Service Fresenius Medical Care


Central Europe Deutschland GmbH
Geschäftsbereich Zentraleuropa
Kundendienst / Servicecenter
Steinmühlstrasse 24b
61352 Bad Homburg
Germany
Phone: +49 6172 609-7100
Fax: +49 6172 609-7102
E-mail: [email protected]

International Fresenius Medical Care


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

Local service

1-4 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 2: Functional Description

2 Functional Description

2.1 Extracorporeal Circuit

The elements for maintaining and monitoring the extracorporeal circuit


of the multiFiltrate are as follows:
– Pumps
– Heaters
– Pressure transducer
– Air detector
– Venous clamp
– Non-opaque/opaque fluid detector
– Blood leak detector
– Heparin pump

2.1.1 Pumps

Altogether, the multiFiltrate is provided with four pumps:

Pump Delivery rate

Blood pump 10 – 500 ml/min

Filtrate pump 10 – 180 ml/min

Substituate pump 10 – 170 ml/min

Dialysate pump 10 – 170 ml/min

The pumps are driven by direct-current geared motors. To control the


speed, these motors are each provided with a clock pulse generator,
which is directly connected to the motor shaft. The pump processors for
controlling the individual pumps (P.C.B. LP 123) are fitted on the motor
housing.

All pumps are supplied with 24 V. The nominal voltage of the blood
pump motor is 20 V. The nominal voltage of the other pumps, however,
is 24 V.
A Hall sensor in the pump housing and a permanent magnet in each
pump door monitor the state of the pump door.
The line inserting position of the pump rotors for inserting and removing
the pump segments is detected by a combination of a reed switch (in
the pump housing) and a permanent magnet (in the rotor).
The functional test covers a check of all pumps.

Fresenius Medical Care multiFiltrate TM 6/03.07 2-1


Chapter 2: Functional Description

2.1.2 Heaters

To allow heating of replacement fluids, two heaters, which are activated


and monitored independently of each other, are installed in the
multiFiltrate.

The heater foil is applied to the outside of the heater rod and supplied
with approx. 28 V. The temperatures are controlled and monitored by
altogether four NTC sensors (two for the operating processor and two
for the safety processor). This is implemented on P.C.B. LP 122.

Both heaters are tested during the functional test.

2.1.3 Pressure Transducer

Four pressures are measured at the multiFiltrate:


– Arterial pressure,
Measuring transducer (P.C.B. LP 343-1) between the patient’s
arterial access and the blood pump
Measuring range: –280 – 300 mmHg
– Pre-hemofilter pressure
Measuring transducer (P.C.B. LP 343-1) between the blood pump
and the filter inlet
Measuring range: 0 – 750 mmHg
– Venous pressure,
Measuring transducer (P.C.B. LP 450-3) between the filter outlet
and the patient’s venous access,
Measuring range: –80 – 500 mmHg.
– Filtrate pressure or dialysate pressure
Measuring transducer (P.C.B. LP 343-1) between the filter
connector and the filtrate pump
Measuring range: –300 – 300mmHg.
All pressure transducers are subjected to the functional tests.

2.1.4 Air Detector and Venous Clamp

The air detector (P.C.B. LP 450-3) serves for the detection of air in the
extracorporeal blood circuit and operates on the ultrasound principle .
Both the transmitter and the receiver are integrated in the drip chamber
holder. Once the level in the venous drip chamber has fallen below a
certain threshold, the venous clamp is closed. This function is executed
independently of the operating or safety processor. The additional
board AD 28 increases the transmitter voltage during Preparation to
ensure that the level of saline solution is reliably detected.
The air detector is subjected to the functional test.

2-2 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 2: Functional Description

2.1.5 Optical Detector (Non-Opaque/Opaque Fluid Detector)

The optical detector (P.C.B. LP 450-3) detects, according to the infrared


principle, whether saline solution or blood is present in the tubing
system.
The optical detector is subjected to the functional test.

2.1.6 Blood Leak Detector

The blood leak detector (P.C.B. LP 125) is provided for the detection of
a potential blood loss through the membrane. It is operated applying a
two-color measuring section. In the course of this, red and green light is
alternately transmitted to a reference receiver or, through the filtrate
line, to a measuring receiver.
Both the transmitter and the receiver are integrated in the line holder.
The blood leak detector is subjected to the functional test.

2.1.7 Heparin Pump

The heparin pump is used for continuous heparinization of the blood.

A syringe plunger is moved by means of a carriage bar. The carriage


bar is connected to a threaded spindle via a slide. A microprocessor-
controlled stepper motor causes the spindle to rotate. Depending on the
activation, the piston will move up or down.

One Hall sensor each signals when the piston has reached its upper
and lower end of travel. The safety system of the pump comprises a
speed monitoring device (slotted disc with optical sensor) and a motor
current monitoring function. The syringe types are set via a coding
switch (HEX switch).

2.2 Weighing Units

The weighing units are used for managing the fluid balance during
treatment.
The weighing cells are operated according to the strain gauge principle.
Signal conditioning, including analog-to-digital conversion, is achieved
per weighing cell on the P.C.B. LP 127. The actual weights are
produced by the operating processor.

Scale 1 and scale 2 each have a useful load of approx. 12 kg.

The scales are subjected to the functional test. To test the scales, a test
weight (ball) of defined value must be taken off each scale. Proper
functioning of the scales can be concluded from the correct difference
between the weights before and after lifting.

Fresenius Medical Care multiFiltrate TM 6/03.07 2-3


Chapter 2: Functional Description

2.3 Ci-Ca Module (Option)

The Ci-Ca module is intended for regional citrate anticoagulation in the


CVVHD treatment therapy.

Turning power on The Ci-Ca module requires a supply voltage of 24VDC. This voltage is
provided by the multiFiltrate system's power supply unit via the
connector in the lower IV pole support of the IV pole located on the right
of the system.
After the multiFiltrate system was turned on by pressing the power
switch on its rear, the supply voltage of the module is connected. The
operating processor of the Ci-Ca module switches into the standby
mode.
If the multiFiltrate systems is then turned on via the I/O key on the front
of the system, the operating processor of the Ci-Ca module will perform
an internal processor test. This test is performed simultaneously to the
processor test of the multiFiltrate system.
The Ci-Ca module communicates with the multiFiltrate basic system via
a serial interface.

Processor test If a test is not passed successfully, the module will not establish
communications with the multiFiltrate system. It is not possible to
perform a treatment with citrate anticoagulation. The multiFiltrate
system recognizes this problem and displays a message which
proposes to use an alternative anticoagulation equipment (e.g. heparin
pump) and which has to be confirmed by the operator.

T1 test The Ci-Ca module performs its own T1 test, independent of the T1 test
of the multiFiltrate system. This test will be started automatically and
simultaneously to the multiFiltrate T1 test after the prompt whether the
starting conditions are met was confirmed with [OK].
This test cannot be skipped or deselected.

System errors If it is still possible, system errors in the Ci-Ca module are shown on the
multiFiltrate display with the indication that citrate anticoagulation is not
available.

2.4 Functional Test (T1 Test) and Error Messages

After it has been turned on the rear and the [I/O] key has been pressed,
the system automatically starts the processor test. After completion of
the processor test, the display test will be performed. In this test, the
numerical characters are represented for 2 seconds in all of the three
fonts used. After this test, the functional test (T1 test) is started
automatically. Depending on the configuration in the SETUP (SETUP
automatic), the test is running in the background or (SETUP detailed)
the test steps are represented separately on the display.

2-4 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 2: Functional Description

2.4.1 Battery Test, Part 1

At the beginning of the T1 test, the system assumes the terminal voltage
and loads the battery with a defined resistance over the entire test.

2.4.2 Scales Test

In the first step, the temperature compensation and calibration factors


are tested. In the second step, the scales are tared. The linearity test
follows in step three. The 4 test weights are lifted, and the weight (44.3
g) is tested for a tolerance of ±0.5 g. The offset drift is tested in step four.
The test weights are lowered again; the system expects a weight of 0.0
g with a tolerance of ±0.5 g. The time out for each step (2 to 4) is 10 sec.
In the event of an error, messages are emitted. Here, the error
messages section only relates to scales I. The messages are identical
for scales II to IV.

Error message Causes Action required

Scale I Lithium battery on P.C.B. LP 244- Replace the battery and execute
OP discharged. the calibration step in the Service
Cal. factor missing, error.
program.
Acknowledge with
[START/RESET] key.

Scale I Defect of the EPROM on P.C.B. Replace the P.C.B. and the
LP 127 of the scales specified. weighing bar and execute the
Temp. coeff. factors missing, error.
calibration step in the Service
Acknowledge with
program.
[START/RESET] key.

Scale I The system is not in a stable Set up the system in a stable


position. The scales are subjected position. Remove the system from
Movement detected on Scale I.
to a draft. Bags with tubing system the draft, or close the window.
Acknowledge with
are placed on the scales; this is Relieve the scales.
[START/RESET] key.
especially applicable to filtrate
scales.

The +12 V and/or –12 V voltage(s) Check the fuses on the PSU board
is (are) missing. LP 128 and replace the P.C.B.
LP 128, if necessary.
Caution: All pressures must be
checked and calibrated, if
necessary.

Scales mechanics not smooth. Check for smoothness and adjust,


if necessary. Weight check in the
Service program.

Connector not fitted or defective Fit the connector to the


ribbon cable. motherboard and/or to the P.C.B.
LP 127. Replace the ribbon cable.

P.C.B. LP 244-OP defective. Replace P.C.B. LP 244-OP.


Caution: All scales and pressures
must be calibrated.

Fresenius Medical Care multiFiltrate TM 6/03.07 2-5


Chapter 2: Functional Description

Error message Causes Action required

Scale I The system is not in a stable Set up the system in a stable


position. The scales are subjected position. Remove the system from
Test weight outside tolerance.
to a draft. Bags with tubing system the draft, or close the window.
Acknowledge with
are placed on the scales; this is Relieve the scales.
[START/RESET] key.
especially applicable to filtrate
scales.

Lifting magnet for ball not Fit the connector to the


connected or defective. motherboard. If defective, the lifting
magnet must be replaced.

Ball mechanics not smooth. Check for smoothness and adjust,


if necessary. Weight check in the
Service program.

Scale I The system is not in a stable Set up the system in a stable


position. The scales are subjected position. Remove the system from
Zero offset outside tolerance.
to a draft. Bags with tubing system the draft, or close the window.
Acknowledge with
are placed on the scales; this is Relieve the scales.
[START/RESET] key.
especially applicable to filtrate
scales.

Scales mechanics not smooth. Check for smoothness and adjust,


if necessary. Weight check in the
Service program.

Test weight fails to drop back. Ball Check for smoothness and adjust,
mechanics not smooth. if necessary. Weight check in the
Service program (ESC Service).

2.4.3 Pump Test

In the first step, the stop-by-OP function is tested, i.e. the pumps must
stop running. In this step, the safety processor releases the pumps, and
the operating processor does not activate the pumps. In the second
step, all of the four pumps are activated with a rate of 100 ml/min. The
safety processor checks whether the pumps are running at the correct
rate and whether the reed contact (line inserting position) is actuated. In
the third step, the operating processor activates the pumps and the
safety processor disables the pump activation, i.e. the pumps may not
be running. In the event of an error, messages are emitted. Here, the
error messages section only relates to the blood pump. The messages
are identical for the other pumps, i.e. the filtrate, substituate and
dialysate pumps.

2-6 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 2: Functional Description

Error message Causes Action required

Blood pump Blood pump door open. Close the blood pump door.
Blood pump door open. Magnet in blood pump door Replace the blood pump door.
Acknowledge with missing.
[START/RESET] key.
Hall sensor in pump housing not Plug the connector onto the
connected or defective. appropriate P.C.B. LP 123 or
replace the pump housing.

Control electronics (P.C.B. LP 123) Replace P.C.B. LP 123.


of the specified pump defective.

P.C.B. LP 244-SR defective. Replace P.C.B. LP 244-SR.


Caution: The BLD must be
calibrated.

Blood pump Control electronics (P.C.B. LP 123) Replace P.C.B. LP 123.


of the specified pump defective.
Not stopped by operating
processor. P.C.B. LP 244-SR defective. Replace P.C.B. LP 244-SR.
Acknowledge with
[START/RESET] key. Caution: The BLD must be
calibrated.

Blood pump Clock pulse generator of motor on Connect the clock pulse generator
P.C.B. LP 123 not connected. socket.
Wrong speed, rate.
Acknowledge with Control electronics (P.C.B. LP 123) Replace P.C.B. LP 123.
[START/RESET] key. of the specified pump defective.

Defect of the clock pulse generator Replace the geared motor.


on the geared motor.
Caution: Blood pump
20 V/3300 rpm; all other pumps
24 V/3300 rpm.

Blood pump Magnet in rotor missing, defective. Replace the rotor.


Reed contact – line threading Reed switch in pump housing not Plug the connector onto the
position connected or defective. appropriate P.C.B. LP 123 or
Acknowledge with replace the pump housing.
[START/RESET] key.
Control electronics (P.C.B. LP 123) Replace P.C.B. LP 123.
of the specified pump defective.

P.C.B. LP 244-SR defective. Replace P.C.B. LP 244-SR.


Caution: The BLD must be
calibrated.

Fresenius Medical Care multiFiltrate TM 6/03.07 2-7


Chapter 2: Functional Description

Error message Causes Action required

Blood pump +24-V supply voltage missing. Check the fuse on the PSU board
LP 128. If necessary, replace
Stop.
P.C.B. LP 128.
Acknowledge with
[START/RESET] key. Caution: All pressures must be
checked and calibrated, if
necessary.

Control electronics (P.C.B. LP 123) Replace P.C.B. LP 123.


of the specified pump defective.

P.C.B. LP 244-OP defective. Replace P.C.B. LP 244-OP.


(The pumps are activated serially,
Caution: All scales and pressures
i.e. the operating processor is
must be calibrated.
defective only if all pumps fail to be
activated.)

Blood pump Control electronics (P.C.B. LP 123) Replace P.C.B. LP 123.


of the specified pump defective.
Not stopped by safety processor.
Acknowledge with P.C.B. LP 244-SR defective. Replace P.C.B. LP 244-SR.
[START/RESET] key.
Caution: The BLD must be
calibrated.

2.4.4 Pressure Transducer

In the first step, the zero point, amplification and detuning factors are
tested. In the second step, the zero points of the pressure transducers
are checked with a tolerance of ±20 mmHg. In the third step, Part and
Pven are detuned to 300 mmHg. The values are checked with a
tolerance of ±20 mmHg. In the fourth step, PPHF and PFil are detuned
to 300 mmHg. The values are checked with a tolerance of ±20 mmHg.
In the event of an error, messages are emitted. The following table only
shows the error messages for "arterial pressure". The messages are
identical for the venous, pre-hemofilter and filtrate pressures.

Error message Causes Action required

Arterial pressure Lithium battery on P.C.B. LP 244- Replace the battery and execute
OP discharged. the calibration step in the Service
Factors / Offset lost.
program.
Acknowledge with
[START/RESET] key.

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Chapter 2: Functional Description

Error message Causes Action required

Arterial pressure Zero point drifted off. Check the setting and calibrate the
pressure in the Service program.
Zero outside tolerance.
Acknowledge with P.C.B. LP 343-1 (for venous Replace P.C.B. LP 343-1 (LP 450-
[START/RESET] key. pressure: P.C.B. LP 450-3) 3) and calibrate the pressure in the
defective. Service program.
Caution: When replacing the
P.C.B. LP 450-3, check / adjust the
air detector, optical detector and
venous pressure transducer.

P.C.B. LP 244-OP defective. Replace P.C.B. LP 244-OP.


Caution: All scales and pressures
must be calibrated.

Arterial pressure Amplification drifted off. Check the setting and calibrate the
pressure in the Service program.
Detuning outside tolerance
Acknowledge with P.C.B. LP 343-1 (for venous Replace P.C.B. LP 343-1 (LP 450-
[START/RESET] key. pressure: P.C.B. LP 450-3) 3) and calibrate the pressure in the
defective. Service program.
Caution: When replacing the
P.C.B. LP 450-3, check / adjust the
air detector, optical detector and
venous pressure transducer.

P.C.B. LP 244-OP defective. Replace P.C.B. LP 244-OP.


Caution: All scales and pressures
must be calibrated.

2.4.5 Optical Detector

In the first step, the non-opaque state is checked. In the second step,
the optical detector is detuned and the opaque state is checked. In the
event of an error, messages are emitted.

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Chapter 2: Functional Description

Error message Causes Action required

Opt. detector Blood present in the system or Remove the blood line or the
objects inserted in the OD. objects from the OD.
Senses opaque fluid.
Acknowledge with OD adjusted improperly. Check the setting of the OD.
[START/RESET] key.
P.C.B. LP 450-3 defective. Replace the P.C.B. LP 450-3.
Caution: When replacing the
P.C.B. LP 450-3, check / adjust the
air detector, optical detector and
venous pressure transducer.

Measuring head of OD defective. Replace and adjust the OD


measuring head.

P.C.B. LP 244-SR defective. Replace P.C.B. LP 244-SR.


Caution: The BLD must be
calibrated.

Opt. detector OD adjusted improperly. Check the setting of the OD.


Fails to sense opaque fluid after P.C.B. LP 450-3 defective. Replace the P.C.B. LP 450-3.
attenuation.
Acknowledge with Caution: When replacing the
[START/RESET] key. P.C.B. LP 450-3, check / adjust the
air detector, optical detector and
venous pressure transducer.

P.C.B. LP 244-OP defective. Replace P.C.B. LP 244-OP.


Caution: All scales and pressures
must be calibrated.

AD 28 defective. Replace AD 28-1.

2.4.6 Air Detector

In the first step, it is checked whether fluid is present in the drip


chamber. if YES, the clamp is activated (opened). In the second step,
the air detector is detuned and the alarm state checked. In the event of
an error, messages are emitted.

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Chapter 2: Functional Description

Error message Causes Action required

Air detector LD adjusted improperly. Check the setting of the LD.


LDA1 – not in alarm mode. P.C.B. LP 450-3 defective. Replace the P.C.B. LP 450-3.
Acknowledge with
[START/RESET] key. Caution: When replacing the
P.C.B. LP 450-3, check / adjust the
air detector, optical detector and
venous pressure transducer.

Ultrasonic detector defective. Replace and adjust the ultrasonic


detector.

P.C.B. LP 244-SR defective. Replace P.C.B. LP 244-SR.


Caution: The BLD must be
calibrated.

Air detector LD adjusted improperly (LDA2). Check the setting of the LD.
Clamp does not close. P.C.B. LP 450-3 defective. Replace the P.C.B. LP 450-3.
Acknowledge with
[START/RESET] key. Caution: When replacing the
P.C.B. LP 450-3, check / adjust the
air detector, optical detector and
venous pressure transducer.

P.C.B. LP 244-SR defective. Replace P.C.B. LP 244-SR.


Caution: The BLD must be
calibrated.

2.4.7 Blood Leak Detector

In the first step, the blood leak detector is checked for being in an
acceptable state. In the second step, the blood leak detector is detuned
and the alarm state checked. In the event of an error, messages are
emitted.

Error message Causes Action required

Blood leak detector Lithium battery on P.C.B. LP 244- Replace the battery and execute
SP discharged. the calibration step in the Service
Calibration values incorrect
program.
or missing.
Acknowledge with
[START/RESET] key.

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Chapter 2: Functional Description

Error message Causes Action required

Blood leak detector Empty filtrate line or objects Remove the filtrate line or the
inserted in the BLD sensor head. objects.
Outside acceptable range.
Remove filtrate line. P.C.B. LP 125 and/or BLD sensor Replace P.C.B. LP 125 and the
Acknowledge with head defective. BLD sensor head, and calibrate the
[START/RESET] key. BLD.

P.C.B. LP 244-SR defective. Replace P.C.B. LP 244-SR.


Caution: The BLD must be
calibrated.

Blood leak detector P.C.B. LP 125 and/or BLD sensor Replace P.C.B. LP 125 and the
head defective. BLD sensor head, and calibrate the
Alarm-free after signal attenuation.
BLD.
Acknowledge with
[START/RESET] key. P.C.B. LP 244-OP defective. Replace P.C.B. LP 244-OP.
Caution: All scales and pressures
must be calibrated.

2.4.8 Heater

In the first step, the safety relay is checked for being in the open state.
In addition, the sensors are checked for interruption and short-circuit. In
the second step, the safety relay is activated and checked for being in
the closed state. In the third step, the bag and foil sensors of OP and
SP are checked for being synchronized. Tolerances are ±1 °C. In the
fourth step, the foil sensor is detuned to >120 °C and, thus, the safety
shutoff mechanism (fire protection) is checked. In the fifth step, the bag
and foil sensors are detuned to >41 °C to check whether the heater is
switched off in case of an overtemperature of the solutions. In the sixth
step, it is checked whether the heater can be activated. In the event of
an error, messages are emitted. Here, the error messages section only
relates to the lower heater. The messages are identical for the upper
heater.

Error message Causes Action required

Lower heater Safety relay on P.C.B. LP 122 Replace P.C.B. LP 122.


defective.
Switch-off path SP defective
(Sub. relay not open) Activation on P.C.B. LP 244-SR Replace P.C.B. LP 244-SR.
Voltage missing. defective.
Fuse defective. Caution: The BLD must be
Acknowledge with calibrated.
[START/RESET] key. Supply voltage for heater not Fit the socket on P.C.B. LP 122.
connected.

Fuse on P.C.B. LP 122 defective. Replace the fuse.

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Chapter 2: Functional Description

Error message Causes Action required

Lower heater Control FET defective. Replace P.C.B. LP 122.


Control FET short-circuit Activation on P.C.B. LP 244-OP Replace P.C.B. LP 244-OP.
Acknowledge with defective.
[START/RESET] key. Caution: All scales and pressures
must be calibrated.

Lower heater Socket of sensors not fitted. Fit the socket on P.C.B. LP 122.
Bag sensor broken. Sensor interrupted. Replace the heater.
Acknowledge with
[START/RESET] key. P.C.B. LP 122 defective Replace P.C.B. LP 122.

Converter on P.C.B. LP 244-SR Replace P.C.B. LP 244-SR.


defective.
Caution: The BLD must be
calibrated.

Lower heater Socket of sensors not fitted. Fit the socket on P.C.B. LP 122.
Foil sensor broken. Sensor interrupted. Replace the heater.
Acknowledge with
[START/RESET] key. P.C.B. LP 122 defective Replace P.C.B. LP 122.

Converter on P.C.B. LP 244-SR Replace P.C.B. LP 244-SR.


defective.
Caution: The BLD must be
calibrated.

Lower heater Bag sensor short-circuit. Replace the heater.


Bag sensor short-circuit. P.C.B. LP 122 defective Replace P.C.B. LP 122.
Acknowledge with
[START/RESET] key. Converter on P.C.B. LP 244-SR Replace P.C.B. LP 244-SR.
defective.
Caution: The BLD must be
calibrated.

Lower heater Bag sensor short-circuit. Replace the heater.


Foil sensor short-circuit. P.C.B. LP 122 defective Replace P.C.B. LP 122.
Acknowledge with
[START/RESET] key. Converter on P.C.B. LP 244-SR Replace P.C.B. LP 244-SR.
defective.
Caution: The BLD must be
calibrated.

Lower heater Supply voltage for heater not Fit the socket on P.C.B. LP 122.
connected.
Sub. relay not closed,
foil defective. Fuse on P.C.B. LP 122 defective. Replace the fuse.
Acknowledge with
[START/RESET] key. Heater foil not connected. Connect the heater foil to P.C.B.
LP 122.

Heater foil interrupted. Replace the heater.

Safety relay defective. Replace P.C.B. LP 122.

Activation on P.C.B. LP 244-SR Replace P.C.B. LP 244-SR.


defective.
Caution: The BLD must be
calibrated.

Fresenius Medical Care multiFiltrate TM 6/03.07 2-13


Chapter 2: Functional Description

Error message Causes Action required

Lower heater Heater still warm after last Allow the heater to cool down.
treatment or Service program.
Bag sensors,
OP-SP not synchronous Sensor board (P.C.B. LP 1220) Replace the heater.
Acknowledge with defective.
[START/RESET] key.
P.C.B. LP 122 defective Replace P.C.B. LP 122.

Converter on P.C.B. LP 244-SR Replace P.C.B. LP 244-SR.


defective.
Caution: The BLD must be
calibrated.

Converter on P.C.B. LP 244-OP Replace P.C.B. LP 244-OP.


defective.
Caution: All scales and pressures
must be calibrated.

Lower heater Heater still warm after last Allow the heater to cool down.
treatment or Service program.
Foil sensors,
OP-SP not synchronous Sensor board (P.C.B. LP 1220) Replace the heater.
Acknowledge with defective.
[START/RESET] key.
P.C.B. LP 122 defective Replace P.C.B. LP 122.

Converter on P.C.B. LP 244-SR Replace P.C.B. LP 244-SR.


defective.
Caution: The BLD must be
calibrated.

Converter on P.C.B. LP 244-OP Replace P.C.B. LP 244-OP.


defective.
Caution: All scales and pressures
must be calibrated.

Lower heater DIL relay on P.C.B. LP 122 Replace P.C.B. LP 122.


defective.
Foil sensor detuning,
no overtemperature cutoff.
Acknowledge with
[START/RESET] key.

Lower heater DIL relay on P.C.B. LP 122 Replace P.C.B. LP 122.


defective.
Bag sensor detuning,
no overtemperature. Activation on P.C.B. LP 244-OP Replace P.C.B. LP 244-OP.
Acknowledge with defective.
[START/RESET] key. Caution: All scales and pressures
must be calibrated.

2-14 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 2: Functional Description

Error message Causes Action required

Lower heater DIL relay on P.C.B. LP 122 Replace P.C.B. LP 122.


defective.
Foil sensor detuning,
no overtemperature. Activation on P.C.B. LP 244-OP Replace P.C.B. LP 244-OP.
Acknowledge with defective.
[START/RESET] key. Caution: All scales and pressures
must be calibrated.

Lower heater FET on P.C.B. LP 122 defective. Replace P.C.B. LP 122.


FET control defective Activation on P.C.B. LP 44-OP Replace P.C.B. LP 244-OP.
Acknowledge with defective.
[START/RESET] key. Caution: All scales and pressures
must be calibrated.

2.4.9 Battery Test, Part 2

The first step was carried out at the beginning of the functional test, with
acceptance of the starting value and loading of the battery. In the
second step, the voltage is checked after loading and is compared with
the starting value. In the event of an error, messages are emitted.

Error message Causes Action required

Battery test Battery not connected. Connect the rechargeable battery.


Battery not connected, defective. Battery terminal voltage without Replace the battery.
Acknowledge with load <<18 V.
[START/RESET] key.
Converter on P.C.B. LP 244-OP Replace P.C.B. LP 244-OP.
defective.
Caution: All scales and pressures
must be calibrated.

Battery test Resistor or load relay on the PSU, Replace P.C.B. LP 128.
P.C.B. LP 128, defective.
Load test failed. Caution: All pressures must be
Acknowledge with checked and calibrated, if
[START/RESET] key. necessary.

Converter or activation on P.C.B. Replace P.C.B. LP 244-OP.


LP 244-OP defective.
Caution: All scales and pressures
must be calibrated.

Fresenius Medical Care multiFiltrate TM 6/03.07 2-15


Chapter 2: Functional Description

Error message Causes Action required

Battery test System not used for a prolonged Load the battery from the mains for
period or frequent power failure a minimum of 10 hours.
Insufficient capacity.
(preparation).
Acknowledge with Replace the battery.
[START/RESET] key. Battery defective.

Charging circuit on the PSU board, Replace P.C.B. LP 128.


P.C.B. LP 128, defective.
Caution: All pressures must be
checked and calibrated, if
necessary.

Converter on P.C.B. LP 244-OP Replace P.C.B. LP 244-OP.


defective.
Caution: All scales and pressures
must be calibrated.

2.4.10 Audible Alarm

In the first step, it is checked whether the audible alarm is silenced. In


the second step, the audible alarm is generated and checked for proper
functioning by means of a microphone. In the event of an error,
messages are emitted.

Error message Causes Action required

Audible alarm Constant ambient noise. Repeat the test after the noise has
stopped.
Not silenced.
Acknowledge with Loud humming noise on the Check the route of the loudspeaker
[START/RESET] key. loudspeaker. cable. Replace the loudspeaker-
microphone unit or the
motherboard P.C.B. LP 124.

The microphone line is disturbed. Check the route of the microphone


cable.

Microphone or amplifier defective. Replace the loudspeaker-


microphone unit or the
motherboard P.C.B. LP 124.

Audible alarm Alarm tone not audible. Loudspeaker cable connected to


P.C.B. LP 124?
Not active.
Acknowledge with Replace the loudspeaker-
[START/RESET] key. microphone unit or the
motherboard P.C.B. LP 124.

Error message despite audible Microphone cable connected to


alarm. P.C.B. LP 124?
Replace the loudspeaker-
microphone unit or the
motherboard P.C.B. LP 124.

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Chapter 2: Functional Description

2.4.11 Heparin Pump

After turning power on to the multiFiltrate, a self-test of the heparin


pump will be performed. Immediately before the multiFiltrate self-test,
the operating processor will query the heparin pump status. In the event
of an error, messages are emitted. If the heparin pump is not installed,
not connected to the power supply or deactivated via Service option, no
error message will be displayed.

Error message Causes Action required

Heparin pump Heparin pump does not respond. Acknowledge with


[START/RESET] key.
Heparin pump not ready.
No communication. Heparin pump deactivated.

Heparin pump Heparin pump manually Acknowledge with


deactivated in the Service mode [START/RESET] key.
Heparin pump optionally
deactivated in Service mode Heparin pump deactivated.

Heparin pump Internal heparin pump error without Acknowledge with


definite cause. [START/RESET] key.
Heparin pump detects internal error
Heparin pump deactivated.

Heparin pump Wrong syringe type set. Acknowledge with


[START/RESET] key.
Wrong / unauthorized syringe type
detected Heparin pump deactivated.
Select a valid syringe type.
0 = 50 ml P syringe

1 = 30 ml heparin syringe
2 = 50 ml Injectomat syringe

Heparin pump Heparin pump detects an unknown Acknowledge with


hardware error. [START/RESET] key.
Unknown hardware error
Heparin pump deactivated.

Heparin pump Heparin pump detects an error in Acknowledge with


the gate array. [START/RESET] key.
Heparin pump hardware error
Gate array error Heparin pump deactivated.

Heparin pump A reset occurred during operation. Acknowledge with


[START/RESET] key.
Spike on reset line
Heparin pump deactivated.

Heparin pump Wrong HEX switch position set. Acknowledge with


[START/RESET] key.
Wrong HEX switch position
Heparin pump deactivated.
Set a valid HEX switch position.

Heparin pump Powerdown without 24 V-cutoff. Acknowledge with


[START/RESET] key.
Powerdown
Heparin pump deactivated.

Fresenius Medical Care multiFiltrate TM 6/03.07 2-17


Chapter 2: Functional Description

Error message Causes Action required

Heparin pump Erroneous data transmission. Acknowledge with


Wrong or missing characters. [START/RESET] key.
Operating processor internal
Check sum error.
communication error with heparin Heparin pump deactivated.
pump

Heparin pump The watchdog is not able to Acknowledge with


interrupt the 24 V control voltage [START/RESET] key.
Watchdog error
for the stepper motor.
Heparin pump deactivated.

Heparin pump The CRC protection of the data Acknowledge with


saved in the E2PROM is not [START/RESET] key.
NOVRAM error
correct.
Heparin pump deactivated.

Heparin pump Not used in the multiFiltrate. Not used in the multiFiltrate.
CAMUS transmission error

2.4.12 multiDataLink

Immediately before the multiFiltrate self-test, the operating processor


will query the multiDataLink version identifications. A response given by
the mDL is an indicator for its operability. In the event of an error,
messages are emitted. If the multiDataLink is not installed, not
connected to the power supply or deactivated via Service option, no
error message will be displayed.

Error message Causes Action required

multiDataLink multiDataLink does not respond. Acknowledge with


[START/RESET] key.
multiDataLink not standby
No communication multiDataLink deactivated.

multiDataLink multiDataLink manually Acknowledge with


deactivated in the Service program. [START/RESET] key.
multiDataLink optionally
deactivated in Service mode multiDataLink deactivated.
Activate multiDataLink in the
Service program.

2.4.13 Ci-Ca Module (Option)

The test for the Ci-Ca module can not be enabled if the processor test
of the module and the multiFiltrate was not passed successfully. If these
processor tests are performed successfully, the T1 test will be started
automatically as soon as the operator has confirmed that the starting
conditions are met.
The following functions of the Ci-Ca module are tested:

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Chapter 2: Functional Description

– Stop of the citrate and the calcium pump by the module's operating
processor
– Stop of the citrate and the calcium pump by the system's watchdog.
– Function of the citrate pump and the insertion switch
– Function of the calcium pump and the insertion switch
If a test could not be passed successfully, a warning indicating an error
number appears on the multiFiltrate display. The test can be repeated
any number of times, however, it cannot be skipped.
The T1 test of the multiFiltrate system is performed simultaneously to
the T1 test of the Ci-Ca module.

Error Description Possible cause


number

281 Lacking Ci Hall impulse after test was started The rotor of the citrate pump is loose, jammed or
(>5 s). blocked.

282 Ci Hall impulse too early during pump stop test Insertion switch pressed --> citrate line already
(<7 s). inserted.

283 Ci Hall impulse too late during pump stop test The rotor of the citrate pump is loose, jammed or
(>9 s). blocked.

285 Ci Hall impulse too early during pump stop test Insertion switch pressed --> citrate line already
(<7 s). inserted during the test.

286 Ci Hall impulse too late during pump stop test The rotor of the citrate pump is loose, jammed or
(>9 s). blocked.

288 Ci Hall impulse too early during insertion switch Insertion switch pressed --> citrate line already
test (<7 s). inserted during the test.

289 Ci Hall impulse too late during insertion switch The rotor of the citrate pump is loose, jammed or
test (>9 s). blocked.

291 Lacking Ca Hall impulse after test was started The rotor of the Ca pump is loose, jammed or
(>5 s). blocked.

292 Ca Hall impulse too early during pump stop test Insertion switch pressed --> calcium line already
(<7 s). inserted.

293 Ca Hall impulse too late during pump stop test The rotor of the Ca pump is loose, jammed or
(>9 s). blocked.

295 Ca Hall impulse too early during pump stop test Insertion switch pressed --> calcium line already
(<7 s). inserted during the test.

296 Ca Hall impulse too late during pump stop test The rotor of the Ca pump is loose, jammed or
(>9 s). blocked.

298 Ca Hall impulse too early during insertion switch Insertion switch pressed --> calcium line already
test (<7 s). inserted during the test.

299 Ca Hall impulse too late during insertion switch The rotor of the Ca pump is loose, jammed or
test (>9 s). blocked.

Fresenius Medical Care multiFiltrate TM 6/03.07 2-19


Chapter 2: Functional Description

2.5 Error Messages

2.5.1 Alarm Messages

These messages cause all pumps to stop

Code Description

E10 Blood pump: Blood pump door open

E11 Blood pump: Stop

E12 Blood pump: Wrong speed, rate

E13 Arterial pressure, arterial pressure too low

E14 Arterial pressure, arterial pressure too high

E15 Venous pressure, venous pressure too low

E16 Venous pressure, venous pressure too high

E17 TMP, TMP too low

E18 TMP, TMP too high

E19 System stopped, Stop key has been pressed

E20 Pre-filter pressure/ Pre-filter pressure too low (for


hemoperfusion)

E21 Pre-filter pressure, pre-filter pressure too low

E22 Pre-filter pressure, pre-filter pressure too high

E23 Non-opaque/opaque fluid detector, venous detector


senses non-opaque or opaque fluid

E24 Air detector, air and/or microbubbles

E25 Blood leak detector, blood leak, hemolysis, membrane


rupture

E26 Blood leak detector, 2 min override active

E27 Power failure, emergency operation available for max.


15 min.
Converted by OP from SP code 130.

E28 End of emergency operation, the unit will turn itself off
automatically after 5 minutes.
Converted by OP from SP code 189.

E29 Pre-filter pressure/ Pre-filter pressure too high (for


hemoperfusion)

E30 Blood lines: Blood line jammed / Hydrophobic filter


P_pHF wet

E31 Blood lines: Rotor broken

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Chapter 2: Functional Description

Code Description

E32 Blood lines: Hydrophobic filter Part wet

E33 Blood lines: Hydrophobic filter Pven wet

E34 Air detector: Transmitting voltage on the air detector too


high

E35 Ci-Ca module: Citrate pump turning too slowly (volume


monitoring)

E36 Ci-Ca module: Citrate pump turning too fast (volume


monitoring)

E37 Ci-Ca module: Calcium pump turning too slowly


(volume monitoring)

E38 Ci-Ca module: Calcium pump turning too fast (volume


monitoring)

E39 Ci-Ca module: Dialysis is started although the primed


Ci/Ca lines are not free from air

E40 Ci-Ca module: Drop counter citrate – insufficient


number of drops; check citrate bag, drip chamber and
tubing system!

E41 Ci-Ca module: Number of drops counted by citrate drop


counter too high; check citrate drip chamber and tubing
system!

E42 Ci-Ca module: Drop counter calcium – insufficient


number of drops; check calcium bag, drip chamber and
tubing system!

E43 Ci-Ca module: Number of drops counted by calcium


drop counter too high; check calcium drip chamber and
tubing system!

E44 Ci-Ca module: Citrate pump turning too slowly; (motor


steps)

E45 Ci-Ca module: Citrate pump turning too fast; (motor


steps)

E46 Ci-Ca module: Calcium pump turning too slowly (motor


steps)

E47 Ci-Ca module: Calcium pump turning too fast (motor


steps)

E48 Ci-Ca module: Citrate insertion switch without


contact,Ci pump segment inserted properly?

E49 Ci-Ca module: Calcium insertion switch without


contact,Ca pump segment inserted properly?

E50 Ci-Ca module: The citrate bag change takes more than
2 min; finish bag change!

Fresenius Medical Care multiFiltrate TM 6/03.07 2-21


Chapter 2: Functional Description

Code Description

E51 Ci-Ca module: The Ca bag change takes more than


2 min; finish bag change!

E52-54 Not used

E55 Ci-Ca module: MPS treatment is permitted for a


maximum of 4 hours!; initiate reinfusion!

E56 Ci-Ca module: HP treatment is permitted for a


maximum of 4 hours!; initiate reinfusion!

E57 Ci-Ca module: Balance switched off; Ca supply


interrupted!

E58 Ci-Ca module: System error of Ci-Ca module:


Anitcoagulation with citrate completed!

E59 Ci-Ca module: Drop counter citrate – insufficient


number of drops; Ci bag change required?

E60 Ci-Ca module: Drop counter calcium – insufficient


number of drops; Ca bag change required?

2.5.2 Warning Messages

These messages cause the balancing to stop. The blood circuit will be
maintained.
For error messages no. 132 through 144 the scales must be
recalibrated.

Code Description

W62 Blood pump: Blood pump door open

W63 Filtrate pump: Cover open

W64 Sub pump: Cover open

W65 Dialysate pump: Cover open

W66 Prime mode: No weight loss on sub-scale-post


(HVCVVH)

W67 Prime mode: No weight loss on sub-scale-pre


(HVCVVH)

W68 Bag change: Overload on sub-scale-post (HVCVVH)

W69 Bag change: Sub-scale post underload (HVCVVH)

W70 Opt. detector: is opaque

W71 Opt. detector: Fails to sense opaque fluid after


attenuation

W72 Scale 1: Temp. coeff. factors missing, incorrect

2-22 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 2: Functional Description

Code Description

W73 Scale 2: Temp. coeff. factors missing, incorrect

W74 Scale 3: Temp. coeff. factors missing, incorrect

W75 Scale 4: Temp. coeff. factors missing, incorrect

W76 Scale 1: Calibration factor missing, incorrect

W77 Scale 2: Calibration factor missing, incorrect

W78 Scale 3: Calibration factor missing, incorrect

W79 Scale 4: Calibration factor missing, incorrect

W80 Scale 1: Movement detected on Scale 1

W81 Scale 2: Movement detected on Scale 2

W82 Scale 3: Movement detected on Scale 3

W83 Scale 4: Movement detected on Scale 4

W84 Scale 1: Test weight outside tolerance

W85 Scale 2: Test weight outside tolerance

W86 Scale 3: Test weight outside tolerance

W87 Scale 4: Test weight outside tolerance

W88 Scale 1: Test weight fails to drop back

W89 Scale 2: Test weight fails to drop back

W90 Scale 3: Test weight fails to drop back

W91 Scale 4: Test weight fails to drop back

W92 Air detector: LDA1 – not in alarm mode

W93 Air detector: Clamp fails to close

W94 Lower heater: Switch-off path SP defective (Sub-relay


not open)

W95 Upper heater: Switch-off path SP defective (dial. relay


not open)

W96 Lower heater: Control FET short-circuit

W97 Upper heater: Control FET short-circuit

W98 Lower heater: Bag sensor broken

W99 Lower heater: Foil sensor broken

W100 Upper heater: Bag sensor broken

W101 Upper heater: Foil sensor broken

W102 Lower heater: Bag sensor short-circuit

W103 Lower heater: Foil sensor short-circuit

Fresenius Medical Care multiFiltrate TM 6/03.07 2-23


Chapter 2: Functional Description

Code Description

W104 Upper heater: Bag sensor short-circuit

W105 Upper heater: Foil sensor short-circuit

W106 Lower heater: Sub. relay not closed, foil defective

W107 Upper heater: Dial. relay not closed, foil defective

W108 Lower heater: Foil sensor detuning, no over-


temperature cutoff

W109 Upper heater: Foil sensor detuning, no over-


temperature cutoff

W110 Lower heater: Bag sensors, OP-SP not synchronous

W111 Upper heater: Bag sensors, OP-SP not synchronous

W112 Lower heater: Bag sensor detuning, no


overtemperature

W113 Lower heater: Foil sensor detuning, no overtemperature

W114 Upper heater: Bag sensor detuning, no


overtemperature

W115 Upper heater: Foil sensor detuning, no overtemperature

W116 Lower heater: FET control defective

W117 Upper heater: FET control defective

W118 Battery test: Battery not connected, defective

W119 Battery test: Load test failed

W120 Battery test: Insufficient capacity

W121 Blood leak detector: Outside acceptable range, remove


filtrate line

W122 Blood leak detector: Alarm-free after attenuation

W123 Prime mode: No weight loss on SUB scale

W124 Prime mode: No weight loss on DIA scale

W125 Prime mode: No weight loss on SUB scale (CVVHDF)

W126 Prime mode: No weight loss on DIA scale (CVVHDF)

W127 Blood leak detector: Calibration values missing,


incorrect

W128 Audible alarm: Not silenced

W129 Audible alarm: not active

W130 Power failure: Emergency operation available for max.


15 minutes (OP generates code 27)

2-24 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 2: Functional Description

Code Description

W131 Incorrect allocation of scales, repeat Preparation (very


unusual)

W132 Load on scale, incorrect load on scale I (initial weight)

W133 Load on scale, incorrect load on scale II (initial weight)

W134 Load on scale, incorrect load on scale III (initial weight)

W135 Load on scale, incorrect load on scale IV (initial weight)

W136 Balancing, Scale I, leakage from tubing system, objects

W137 Balancing, Scale II, leakage from tubing system, objects

W138 Balancing, upper scales, leakage from tubing system,


objects

W139 Balancing, filtrate bag full, replace or empty filtrate bag

W140 Balancing, filtrate scales moved, leakage from tubing


system

W141 Scale 1, overload or underload, check load, scale


jammed?

W142 Scale 2, overload or underload, check load, scale


jammed?

W143 Scale 3, overload or underload, check load, scale


jammed?

W144 Scale 4, overload or underload, check load, scale


jammed?

W145 Bag change: Overload on SUB scale (CVVHDF)

W146 Bag change: Overload on SUB scale 1 (CVVH, HF)

W147 Bag change: Overload on SUB scale 2 (CVVH, HF)

W148 Bag change: SUB on wrong scale (CVVHDF)

W149 Bag change: Insufficient substituate (CVVH, HF)

W150 Bag change: Insufficient substituate (CVVHDF)

W151 Bag change: Insufficient saline solution on scale 1


(MPS)

W152 Bag change: Overload on plasma scale 1 (MPS)

W153 Bag change: Overload on plasma scale 2 (MPS)

W154 Bag change: Overload on dialysate scale (CVVHDF)

W155 Bag change: Overload on dialysate scale 1 (CVVHD)

W156 Bag change: Overload on dialysate scale 2 (CVVHD)

W157 Dialysate on wrong scale (tubing arrangement test after


bag change HDF)

Fresenius Medical Care multiFiltrate TM 6/03.07 2-25


Chapter 2: Functional Description

Code Description

W158 Bag change: Insufficient dialysate (CVVHD)

W159 Bag change: Insufficient dialysate (CVVHDF)

W160 Bag change: Overload on filtrate scale

W161 TMP/MPS TMP >100mmHg

W162 Lower heater: MPS temperature > 37°C

W163 Upper heater: MPS temperature > 37°C

W164 Lower heater: Temperature too high

W165 Upper heater: Temperature too high

W166 Bag change: Overload SUB pre (HVCVVH)

W167 Bag change: Insufficient SUB pre (HVCVVH)

W168 Balancing: Ultrafiltration or substitution rate too high

W169 Lower heater: Foil sensors, OP-SP not synchronous

W170 Upper heater: Foil sensors, OP-SP not synchronous

W171 Balancing: Aborted because maximum allowable


deviation of •500g was exceeded

W172 Lower heater: MPS foil temperature too high, risk of


hemolysis

W173 Upper heater: MPS foil temperature too high, risk of


hemolysis

W174 Balancing: Balancing stopped, balancing was switched


off

W175 Battery capacity: Charging voltage too high, battery


deactivated, no power failure

W176 Filtrate scale: Test weight outside tolerance (T0 test)

W177 Filtrate scale: Test weight fails to drop back (T0 test)

W178 Balancing: UF goal reached, ultrafiltration was set to 0

W179 Balancing: Substituate bag empty, replace substituate


bag

W180 Balancing: Dialysate bag empty, replace dialysate bag

W181 Balancing: Movement detected on filtrate scales,


leakage from tubing system

W182 Filtrate scale: Overload or underload, check load, scale


jammed?

W183 Balancing: Plasma bag empty, open outlet line(s) on


plasma bags

W184 Balancing: Plasma pump delivers from wrong scale (I)

2-26 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 2: Functional Description

Code Description

W185 Balancing: Plasma pump delivers from wrong scale (II)

W186 Balancing: Sub-postdilution bag empty, replace


substituate bag

W187 Balancing: Sub-predilution bag empty, replace


substituate bag

W188 End of treatment: Plasma infused (MPS only)

W189 End of emergency operation: The unit will turn itself off
automatically after 5 minutes

W190 Power failure end

W191 Bag change: Insufficient plasma on scale 2

W192 Prime mode: Overload on dialysate scale (CVVHDF)

W193 Prime mode: Overload on SUB scale (CVVHDF)

W194 Prime mode: Insufficient substituate (CVVHDF)

W195 Prime mode: Insufficient dialysate (CVVHDF)

W196 Prime mode: Overload on sub-scale-pre (HVCVVH)

W197 Prime mode: Overload on sub-scale-post (HVCVVH)

W198 Prime mode: Insufficient SUB pre (HVCVVH)

W199 Prime mode: Insufficient SUB post (HVCVVH)

W200 Blood pump: Not stopped by operating processor

W201 Filtrate pump: Not stopped by operating processor

W202 Sub pump: Not stopped by operating processor

W203 Dialysate pump: Not stopped by operating processor

W204 Blood pump: Wrong speed, rate

W205 Filtrate pump: Wrong speed, rate

W206 Sub pump: Wrong speed, rate

W207 Dialysate pump: Wrong speed, rate

W208 Blood pump: Reed contact – line threading position

W209 Filtrate pump: Reed contact – line threading position

W210 Sub pump: Reed contact – line threading position

W211 Dialysate pump: Reed contact – line threading position

W212 Blood pump: Stop

W213 Filtrate pump: Stop

W214 Sub pump: Stop

Fresenius Medical Care multiFiltrate TM 6/03.07 2-27


Chapter 2: Functional Description

Code Description

W215 Dialysate pump: Stop

W216 Blood pump: Not stopped by safety processor

W217 Filtrate pump: Not stopped by safety processor

W218 Sub pump: Not stopped by safety processor

W219 Dialysate pump: Not stopped by safety processor

W220 Arterial pressure: Factors / offset missing, incorrect

W221 Venous pressure: Factors / offset missing, incorrect

W222 PHF pressure: Factors / offset missing, incorrect

W223 Filtrate pressure: Factors / offset missing, incorrect

W224 Arterial pressure: Zero outside tolerance

W225 Venous pressure: Zero outside tolerance

W226 PHF pressure: Zero outside tolerance

W227 Filtrate pressure: Zero outside tolerance

W228 Arterial pressure: Detuning outside tolerance

W229 Venous pressure: Detuning outside tolerance

W230 PHF pressure: Detuning outside tolerance

W231 Filtrate pressure: Detuning outside tolerance

W232 Heparin pump: does not respond

W233 Heparin pump: manually deactivated in Service


program

W234 Heparin pump: detects an internal problem

W235 Heparin pump: Wrong/invalid syringe type

W236 Heparin pump: No anticoagulation

W237 Heparin pump: Anticoagulation stopped

W238 Heparin pump: Anticoagulant Used Up

W239 Heparin pump: Syringe not changed

W240 Heparin pump: Non-registered error code

W241 Heparin pump: Gate-array error

W242 Heparin pump: Restart after spike reset

W243 Heparin pump: Hex switch position error

W244 Heparin pump: Powerdown without 24V cutoff

W245 Heparin pump: Slotted disc error

2-28 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 2: Functional Description

Code Description

W246 Heparin pump: Slotted disc not found

W247 Heparin pump: Communication sumcheck error

W248 Heparin pump: No heparin pump STOP

W249 Heparin pump: Communication error with OP

W250 Heparin pump: Watchdog error

W251 Heparin pump: NOVRAM error

W252 CAMUS transmission error

W253 Not used

W254 Not used

W255 mDL not ready/no communication

W256 mDL deactivated via Service option

W257 The BP rate is < 30 ml/min; no rotor breakage


monitoring; closure of pressure transducer is not
detected.

W259 Lower heater: Switch-off path SP defective (Sub-relay


not open), voltage not present, SI defective (for P.C.B.
LP122-B)

W260 Upper heater: Switch-off path SP defective (dial. relay


not open), voltage not present, SI defective (for P.C.B.
LP122-B)

W261 Lower heater: Control FET short circuit (for P.C.B.


LP122-B)

W262 Upper heater: Control FET short circuit (for P.C.B.


LP122-B)

W263 Air detector: Transmitting voltage for air detector not


present / nonconforming (for AD28)

W264 Ci-Ca module: Ci-Ca module does not respond, select


alternate anticoagulation if necessary!

W265 Ci-Ca module: Switch-off path "sleep" does not react,


select alternate anticoagulation if necessary!

W266 Balancing: HF bag change aborted

W281 Ci-Ca module: Citrate pump - test F1, Rotor slack or


stuck?

W282 Ci-Ca module: Citrate pump - OP test F2, rotor slack?

W283 Ci-Ca module: Citrate pump - OP test F3, rotor slack or


stuck?

W285 Ci-Ca module: Citrate pump - WD test F5, rotor slack?

Fresenius Medical Care multiFiltrate TM 6/03.07 2-29


Chapter 2: Functional Description

Code Description

W286 Ci-Ca module: Citrate pump - WD test F6, rotor slack or


stuck?

W288 Ci-Ca module: Citrate pump - insertion switch test F8,


line pump segment inserted too early or rotor slack?

W289 Ci-Ca module: Citrate pump - insertion switch test F9,


rotor slack or stuck?

W291 Ci-Ca module: Calcium pump test F11, rotor slack or


stuck?

W292 Ci-Ca module: Calcium pump - OP test F12, rotor


slack?

W293 Ci-Ca module: Calcium pump - OP test F13, rotor slack


or stuck?

W295 Ci-Ca module: Calcium pump - WD test F15, rotor


slack?

W296 Ci-Ca module: Calcium pump - WD test F16, rotor slack


or stuck?

W298 Ci-Ca module: Calcium pump - insertion switch test


F18, line pump segment inserted too early or rotor
slack?

W299 Ci-Ca module: Calcium pump - insertion switch test


F19, rotor slack or stuck?

W330 Ci-Ca module: Balance switched off!, Ca supply


interrupted!

W331 Ci-Ca module: Filtrate rate too low for set Ca dose!,
Increase dialysate or substituate or Ca dose if
necessary!

W332 Ci-Ca module: Filtrate rate too high for set Ca dose!,
Reduce dialysate or substituate or Ca dose if
necessary!

W333 Ci-Ca module: Blood flow too low for set citrate dose!,
Increase blood flow or citrate dose if necessary!

W334 Ci-Ca module: Blood flow too high for set citrate dose!,
Reduce blood flow or citrate dose if necessary!

2.5.3 Fatal Errors

These messages cause the treatment to stop.

2-30 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 2: Functional Description

Code Description

E500 Scale 1: (factors missing during treatment)

E501 Scale 2: (factors missing during treatment)

E502 Scale 3: (factors missing during treatment)

E503 Scale 4: (factors missing during treatment)

E504 Memory error: (double values incorrect)

E505 Blood pump: (does not respond)

E506 Substituate pump: (does not respond)

E507 Dialysate pump: (does not respond)

E508 Filtrate pump: (does not respond)

E509 Overvoltage +5V

E510 Overvoltage +12V

E511 Processor test OP: CPU defective,

E512 Processor test OP: Incorrect CRC interrupt vectors

E513 Processor test OP: CRC CRC area defective

E514 Processor test OP: CRC Code area defective

E515 Processor test OP: RAM, bank B defective

E516 Processor test OP: RAM, bank 8 defective

E517 State transition

E518 Program sequence

E519 Self-Test

E520 Balancing

E521 SP does not respond

E522 DP does not respond

E523 Program flow OP: Watchdog

E524 Processor test OP: Watchdog does not respond

E525 Processor test SP: CPU

E526 Processor test SP: Program memory – vectors

E527 Processor test SP: Program memory - CRC area

E528 Processor test SP: Program memory - code area

E529 Processor test SP: RAM - bank B

E530 Processor test SP: RAM - bank B

E531 Processor test SP: Watchdog does not respond

Fresenius Medical Care multiFiltrate TM 6/03.07 2-31


Chapter 2: Functional Description

Code Description

E532 Invalid software combination: OP, DP, SP

E533 Ci-Ca module: Logoff of the option by the MFT

E534 Ci-Ca module: Alarm of the option not followed by MFT


alarm

E535 Ci-Ca module: Timeout of the status message of the


MFT (>2.5 s)

E536 Ci-Ca module: Too many status messages of the MFT


(2x<0.5 s)

E537 Ci-Ca module: Receipt of message not confirmed

E538 Ci-Ca module: unknown identifier

E539 Ci-Ca module: Write buffer full

E540 Ci-Ca module: Read buffer full

E541 Ci-Ca module: Unable to write on TXe

E542 Ci-Ca module: Missing setup values from the MFT (at
end of line installation)

E550 Ci-Ca module: Too many extra Hall pulses from the Ca
pump

E551 Ci-Ca module: Ca pump could not be stopped

E560 Ci-Ca module: Too many extra Hall pulses from the
citrate pump

E561 Ci-Ca module: Citrate pump could not be stopped

E570 Ci-Ca module: Error on checking variable replication


(Int)

E571 Ci-Ca module: Error on checking variable replication


(Float)

E572 Ci-Ca module: Error on checking variable replication


(Long)

E573 Ci-Ca module: Error on checking software diversity

2-32 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 2: Functional Description

2.5.4 Error Codes of “Scales” Lo-Level Routines

Scale no. 1

Code Description

E30001 Standstill not possible (timeout after 10 sec)

E30002 Weight value out of range (overload or underload)

E30003 Incorrect calibration weight value

E30004 Negative initial weight

E30005 Wrong initial weight

E30006 ACT_WGT 65535

E30007 Alarm limits permanently violated

E30008 INF_WGT invalid

E30050 Calibration factor missing or incorrect

E30051 Temp. coeff. factors missing or incorrect

E30052 Double fuse defective (zero value)

E30053 Temperature sensor missing / defective

Scale no. 2

Code Description

E30101 Standstill not possible (timeout after 10 sec)

E30102 Weight value out of range (overload or underload)

E30103 Incorrect calibration weight value

E30104 Negative initial weight

E30105 Wrong initial weight

E30106 ACT_WGT 65535

E30107 Alarm limits permanently violated

E30108 INF_WGT invalid

E30150 Calibration factor missing or incorrect

E30151 Temp. coeff. factors missing or incorrect

E30152 Double fuse defective (zero value)

E30153 Temperature sensor missing / defective

Fresenius Medical Care multiFiltrate TM 6/03.07 2-33


Chapter 2: Functional Description

Scale no. 3

Code Description

E30201 Standstill not possible (timeout after 10 sec)

E30202 Weight value out of range (overload or underload)

E30203 Incorrect calibration weight value

E30204 Negative initial weight

E30205 Wrong initial weight

E30206 ACT_WGT 65535

E30207 Alarm limits permanently violated

E30208 INF_WGT invalid

E30250 Calibration factor missing or incorrect

E30251 Temp. coeff. factors missing or incorrect

E30252 Double fuse defective (zero value)

E30253 Temperature sensor missing / defective

Scale no. 4

Code Description

E30301 Standstill not possible (timeout after 10 sec)

E30302 Weight value out of range (overload or underload)

E30303 Incorrect calibration weight value

E30304 Negative initial weight

E30305 Wrong initial weight

E30306 ACT_WGT 65535

E30307 Alarm limits permanently violated

E30308 INF_WGT invalid

E30350 Calibration factor missing or incorrect

E30351 Temp. coeff. factors missing or incorrect

E30352 Double fuse defective (zero value)

E30353 Temperature sensor missing / defective

2-34 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 2: Functional Description

Scales nos. 3 and 4 (both)

Code Description

E30401 Standstill not possible (timeout after 10 sec)

E30402 Weight value out of range (overload or underload)

E30403 Incorrect calibration weight value

E30404 Negative initial weight

E30405 Wrong initial weight

E30406 ACT_WGT 65535

E30407 Alarm limits permanently violated

E30408 INF_WGT invalid

E30450 Calibration factor missing or incorrect

E30451 Temp. coeff. factors missing or incorrect

E30452 Double fuse defective (zero value)

E30453 Temperature sensor missing / defective

2.5.5 Error Codes of “Pressures” Lo-Level Routines

PART

Code Description

E30551 Calibration factor missing, incorrect

E30552 Offset factor missing, incorrect

E30553 Offset > measurement value

E30557 DAC setting missing, incorrect

PPHF

Code Description

E30651 Calibration factor missing, incorrect

E30652 Offset factor missing, incorrect

E30653 Offset > measurement value

E30657 DAC setting missing, incorrect

Fresenius Medical Care multiFiltrate TM 6/03.07 2-35


Chapter 2: Functional Description

PVEN

Code Description

E30751 Calibration factor missing, incorrect

E30752 Offset factor missing, incorrect

E30753 Offset > measurement value

E30757 DAC setting missing, incorrect

PFIL

Code Description

E30851 Calibration factor missing, incorrect

E30852 Offset factor missing, incorrect

E30853 Offset > measurement value

E30857 DAC setting missing, incorrect

2.5.6 Error Codes of “Heparin Pump” Lo-Level Routines

Code Description

E31000 BCC error

E31001 Handshake error to HP

E31002 Overflow sensitivity: buffer

E31003 Invalid control character

E31004 No end character received

E31005 HP string 3 answered with NAK

E31006 Wrong unknown command from HP

E31008 HP not ready

E31009 HP by option deactivated in Service mode

E31010 HP detects internal error

E31011 Wrong / unauthorized syringe type detected

E31012 HP failed to stop

E31013 Syringe empty

E31014 HP hardware error #1, GA error

2-36 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 2: Functional Description

Code Description

E31015 ditto #4, spike on reset line

E31016 ditto #5, wrong HEX switch position

E31017 ditto #8, power down

E31018 ditto #11, slotted disk error

E31019 ditto #55, slotted disk not found

E31020 Unknown hardware error

E31021 Internal HP communication error (group error)

2.5.7 Error Codes of “Pumps” Lo-Level Routines

Code Hex Description

E64256 0xFB00 Invalid tubing type

E64767 0xFCFF No response from blood pump

E65023 0xFDFF ditto Filtrate pump

E65279 0xFEFF ditto Substituate pump

E65535 0xFFFF ditto Dialysate pump

2.6 Overview of Display Identification Numbers

Fresenius Medical Care multiFiltrate TM 6/03.07 2-37


Chapter 2: Functional Description

A number is displayed in the lower left corner of the screen. This


number is the identification number. When an error occurs, this
numbers permits to identify the machine status.

No. Description

M1 Start-up screen

M2 Self-test window with fonts used

M3 Treatment modes, Selection: Previous/New treatment

M4 Treatment modes, Selection: Delete/Retain balance


data

M5 Treatment modes, Selection of treatment modes

M6 Tubing arrangement (self-test already complete)

M7 Tubing arrangement (self-test not yet complete)

M8 Empty self-test window

M9 Preparation for self-test, with confirmation button "All


conditions fulfilled? "OK" to confirm!"

M10 Preparation, Rinse, with confirmation button "Enter


treatment parameters? "OK" to confirm!"

M11 Preparation, Prime/Rinse tubing system, with


confirmation button "Start priming? "OK" to confirm!"

M12 Preparation, Prime tubing system

M13 Preparation, Treatment parameters menu, depending


on the type of therapy, the DP enters the allowed
parameter fields. With confirmation button ‘All treatment
parameters entered? "OK" to confirm!"

M14 Preparation, Waiting for Patient

M15 Preparation, UF volume, with confirmation button ‘Start


UF rinse? "OK" to confirm!"

M16 Preparation, with count-down UF volume display

M17 Preparation, ‘Waiting for patient’, with confirmation


button ‘Start connection? "OK" to confirm!"

M18 Preparation, "Connect patient"

M19 Preparation, Connect patient, with confirmation button


"Start treatment? "OK" to confirm!"

M20 Treatment, Home page, depending on the type of


therapy, the DP enters the allowed parameter fields.

M21 Treatment, Treatment data menu, depending on the


type of therapy, the DP enters the allowed parameter
fields.

2-38 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 2: Functional Description

No. Description

M22 Treatment, Treatment menu, depending on the type of


therapy, the DP enters the allowed parameter fields. All
treatments, except for HP, are identical.

M23 Treatment, Balance data, depending on the type of


therapy, the DP enters the allowed balance fields.

M24 Treatment, Alarm limits menu Identical for all treatment


modes, for HP, the TMP is renamed into pre-filter
pressure (pF)

M25 Heparin pump syringe change

M26-M28 not used

M29 Bag change

M30-M33 not used

M34 Preparation, Prime sub-pre-tubing system (HV-CVVH)

M35 Treatment, Balance data, Confirmation for ‘Delete


balance data (Yes/No)’, rest like M23

M36-M39 not used

M40 End of treatment, Reinfusion volume, with confirmation


button "Start disconnection? "OK" to confirm!"

M41 End of treatment, Reinfusion volume, with confirmation


button "View treatment parameters? "OK" to confirm!".
The reinfusion volume counts down to "Zero"

M42 End of treatment, with 2 confirmation buttons "Continue


reinfusion / Terminate reinfusion"

M43 End of treatment, Removing tubing system, with


confirmation button "View treatment parameters? "OK"
to confirm!"

M44 End of treatment, View previous treatment parameters


=> Final screen.

M45 End of treatment, view previous treatment parameters


with confirmation button "Previous screen? "OK" to
confirm!"

M46 End of treatment, Reinfusion volume and remaining


time

M47 End of treatment (MPS, plasma return not completed)

M48 End of treatment, confirmation for 'Disconnect without


blood return'

M49 not used

M50 Preparation, Fill plasma

Fresenius Medical Care multiFiltrate TM 6/03.07 2-39


Chapter 2: Functional Description

No. Description

M51 Preparation, Connect patient, with confirmation button


"Start connection? "OK" to confirm!"

M52-M59 not used

M60 System parameters, System parameters menu

M61 System parameters, Default treatment settings, with


confirmation button "All parameters entered? "OK" to
confirm!"

M62 System parameters, Program treatment modes, with


confirmation button "Desired treatment mode selected?
"OK" to confirm!"

M63 System parameters, Software versions, with


confirmation button "Terminate? "OK" to confirm!"

M64 System parameters, Ci-Ca settings, with confirmation


button "All parameters entered? "OK" to confirm!"

M65-M69 not used

M70 Service, Password entry

M71 Service, Calibration main menu

M72 Service, Calibrate/Tare scales

M73 Service, Select pressure

M74 Service, with confirmation button "Pressure sensor


open? "OK" to confirm!"

M75 Service, with pressure value and confirmation button


"Entered? "OK" to confirm!"

M76 Service, with confirmation button "Tubing inserted?


"OK" to confirm!"

M77 System parameters, Event memory, with confirmation


button "Terminate? "OK" to confirm!"

M78 Help menu for M72

M79 Service, Pressure, Weights, Temperatures, Voltages

M80 Service, language selection

M81 mDL parameter assignment

M82-M87 not used

M88 Preparation, Starting conditions Ci-Ca with confirmation


button "Return to treatment selection" and "Conditions
fulfilled"

M89 End of treatment, remove Ci-Ca lines with confirmation


button "Patient disconnected? Start removal of Ci/Ca
lines"

2-40 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 2: Functional Description

No. Description

M90 Preparation, Ci-Ca anticoagulation with confirmation


button "On" and "Off"

M91 Preparation, with prompt "Please wait for completion of


functional test", after prompt was displayed
confirmation button "All conditions fulfilled? "OK" to
confirm!"

M92 Preparation, with note H108. After Z3 protocol the


confirmation button "Ci-Ca clamps opened? Ci-Ca drip
chambers filled? "OK" to confirm!"

M93 Preparation, with note H109. After Z3 protocol


confirmation buttons "Refill citrate", "Refill calcium" and
"Ci-Ca lines primed and free from air? "OK" to confirm!"

M95 Preparation, Deselect Ci-Ca anticoagulation with


confirmation button "No" and "Yes"

M96 Preparation, Deselection Ci-Ca, with note H105 with


confirmation button "All conditions fulfilled? "OK" to
confirm!"

M97 Treatment, Ci-Ca bag change menu, concentrations


and bag volumes displayed, after Z3 protocol 5
confirmation buttons for the Ci-Ca bag exchange
appear.

M98 Preparation, Deselection Ci-Ca, with note H107 with


confirmation button "All conditions fulfilled? "OK" to
confirm!"

Fresenius Medical Care multiFiltrate TM 6/03.07 2-41


Chapter 2: Functional Description

2-42 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 3: Installation

3 Installation

3.1 Preface

Instructions for all technicians who are authorized to commission


our systems.
We, as manufacturers, permanently aim at delivering systems of
highest quality.
To reach this aim, we need your support.
Please commission our systems uniformly using the enclosed "initial
start-up report" and enter the values determined in the columns
provided.
The following is applicable:
Corrections are necessary only if the measured values are outside
of the specified tolerances!
We will then evaluate the initial start-up reports, which will enable us to
monitor the quality of our systems on their delivery.
After initial start-up, please asap send – by mail or by fax – the
completed form (Initial Start-Up Report) back to the following address:
Thank you very much for your help!

Service Fresenius Medical Care


Central Europe Deutschland GmbH
Geschäftsbereich Zentraleuropa
Kundendienst / Servicecenter
Steinmühlstraße 24
61352 Bad Homburg
Germany
Phone: +49 6172 609-7100
Fax: +49 6172 609-7102
E-mail: [email protected]

International Responsible Regional Organization


service (Technical Service)

Fresenius Medical Care multiFiltrate TM 6/03.07 3-1


Chapter 3: Installation

3.2 Important Information on Initial Start-Up

For initial start-up only This technical document is intended for initial start-up only. It is not
intended for restarting systems that have been shut down or have been
put out of service temporarily.

Tester's qualification The initial start-up must be performed by the Technical Service of
Fresenius Medical Care or a person authorized by them.
The initial start-up procedure may only be performed by persons who
are qualified to properly perform the specified checks owing to their
educational background and training, their knowledge and experience
gained in practice. Furthermore, the persons performing the tests must
not be bound by any directives when performing this activity.

Test equipment and The activities described in this technical document require the
accessories availability of the necessary technical test equipment and accessories.
Any information on the specifications must be observed.

Environmental conditions Variations in temperature during transport may lead to condensation


water developing on live parts. In the event of major variations in
temperature, allow sufficient time for the system to adjust to the ambient
temperature before start-up.

TSC/TMC/MA intervals The TSC/TMC/MA procedures for this system are to be performed after
12 months.

3-2 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 3: Installation

3.3 Initial Start-Up Report multiFiltrate

Technician's name: System type including option(s) / software version:

Customer/customer no.: System no.: Inventory no.:

Service report number: Operating hours: Equipment code:

No. Description Meas.


value

1 Unpacking

1.1 Unpack the system.

1.2 Check that all parts of the system have been accounted for.

1.3 System without visible shipping damage.

2 Preparing for operation

2.1 Place the scales trays on the scales plates.

2.2 Install the IV pole.

2.3 Connect the power cable and secure it to prevent improper replacement.

3 Visual inspections

3.1 Fuses accessible from the outside comply with the indicated values.

3.2 Labels and labeling are present and legible.

3.3 The mechanical condition permits further safe use.

3.4 There are no signs of damage or dirt.

3.5 The power cable shows no signs of damage.

4 Functional check

4.1 Pump checked for stopping with open door.

Blood pump
Filtrate pump
Substituate pump
Dialysate pump

4.2 The venous occlusion clamp closes after an air detector alarm.

Fresenius Medical Care multiFiltrate TM 6/03.07 3-3


Chapter 3: Installation

No. Description Meas.


value

4.3 The pressure of 2 bar applied in the venous bubble catcher may not drop by more
than 0.1 bar within 3 minutes.

4.4 Air detector operation/calibration checked.

Jumper J1-P.C.B. LP 450 set to the operation position. Place the checking block into
the air detector. LEDs DI 5 and DI 10 are light.
Jumper J1-P.C.B. LP 450 set to the operation position. Place the adjusting block
into the air detector. LEDs DI 5 and DI 10 are dark.

4.5 Pressure transducers: Zero and gain checked

Arterial pressure (red)


________
Zero point: Display within the range of ± 5mmHg
Amplification: 300Apply 300 mmHg, tolerance ±5 mmHg
________

Venous pressure (blue)


________
Zero point: Display within the range of ± 5mmHg
Amplification: 300Apply 300 mmHg, tolerance ±5 mmHg
________

PHF pressure (white)


________
Zero point: Display within the range of ± 5mmHg
Amplification: 300Apply 300 mmHg, tolerance ±5 mmHg
________

Filtrate pressure (yellow)


________
Zero point: Display within the range of ± 5mmHg
Amplification: 300Apply 300 mmHg, tolerance ±5 mmHg
________

4.6 Scales: calibration with 5000 g test weight

Scale I
_______g
Calibration: Test load on scales: display 5000 g ±1 g

Scales II
_______g
Calibration: Test load on scales: display 5000 g ±1 g

Scales III
_______g
Calibration: Test load on scales: display 5000 g ±1 g

Scales IV
_______g
Calibration: Test load on scales: display 5000 g ±1 g

3-4 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 3: Installation

No. Description Meas.


value

5 Ci-Ca module option: visual inspections

5.1 Colored markings of drop counters must be present.

5.2 Adhesive labels of citrate and calcium pumps are present and legible.

5.3 The mechanical condition permits further safe use.

5.4 There are no signs of damage or dirt.

5.5 Line holders must be present and undamaged.

6 Ci-Ca module option: extracorporeal components

6.1 Citrate drop counter checked for proper function

6.2 Calcium drop counter checked for proper function

6.3 Line occlusion of the pumps checked.

Citrate pump (pressure loss max. 10 mmHg/min) ________


Calcium pump (pressure loss max. 10 mmHg/min) ________

Fresenius Medical Care multiFiltrate TM 6/03.07 3-5


Chapter 3: Installation

No. Description Meas.


value

7 Check of the electrical safety


In Germany according to DIN VDE 0751-1, edition 10/2001.
In other countries, observe the local regulations!

7.1 Visual inspections performed as specified under 3 and 5.

7.2 Protective earth resistance max. 0.3 (with power cable) ______

7.3 Leakage current measurement (device leakage current)


Differential current measurement according to figure C.6
or
Direct measurement according to figure C.5

Nominal voltage of power supply: _______ V

Device leakage current mains polarity 1: _______ ™A

With line voltage: _______ V

Scaled to nominal voltage _____ ™A


(maximum 500 ™A, see Additional conditions)

Device leakage current mains polarity 2: _______ ™A

With line voltage: _______ V

Scaled to nominal voltage _____ ™A


(maximum 500 ™A, see Additional conditions)

7.4 Patient leakage current measurement

7.4.1 For degree of protection type "BF" according to fig. C.8

Nominal voltage of power supply: __________ V

Patient leakage current __________ ™A

for line voltage __________ V

scaled to nominal voltage (maximum 480 ™A, see Additional conditions): _____ ™A

7.4.2 For degree of protection type "CF" according to fig. C.8

Nominal voltage of power supply: __________ V

Patient leakage current __________ ™A

for line voltage __________ V

scaled to nominal voltage (maximum 34 ™A, see Additional conditions): _____ ™A

3-6 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 3: Installation

No. Description Meas.


value

8 Functional test

8.1 Functional test (T1 test) checked for proper performance.

8.2 Ci-Ca option:


After successful completion of the test, screen M86 'Starting conditions' is
displayed.

8.3 Power failure alarm executed.

9 Final check

9.1 Entries made in the Medical Device Register.

9.2 Operating Instructions and accessories package complete and match the system.

Test equipment used:


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

Comments:

Date: Signature: Stamp:

The system has been released for its intended use. Yes
(Attach inspection sticker.)
No

Next
inspection date:

Comments:

Date: Signature: Stamp:

Fresenius Medical Care multiFiltrate TM 6/03.07 3-7


Chapter 3: Installation

3.4 Explanations on the Initial Start-Up Report

Identification

Technician's name:
Technician's first name and surname.
Customer/customer no.:
Number of the final customer.
Service report number:
Number of the service call.
System type including option(s):
System name with possible options and extras.
System no.:
Serial number indicated on the type label.
Inventory no.:
Inventory number assigned to the system.
Operating hours:
Operating hours, if a time meter is installed.
Equipment code:
Equipment code indicated on the system.
(e.g. EC xxx, E-code xxx)

Re: 1.1

Remove the system from its transport packaging and save the
packaging for possible future return shipments.

Re: 1.2

Check that all parts of the system have been accounted for. Inform your
contact at Fresenius immediately of any missing parts.

Re: 4 - Functional check

For detailed information refer to chapter 5 "Adjustment Instructions and


Tests"

Re: 5 - Check of the electrical safety

In Germany according to DIN VDE 0751-1, edition 10/2001.


In other countries, observe the local regulations!
(Use DIN VDE 0751-1, edition 10/2001, for medical products. Use DIN
VDE 0701-1 for electrical production equipment.)

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Chapter 3: Installation

Re: 5.2 Protective earth resistance measurement points

5
6

Legend

1 Luer locks
2 Venous clamp
3 Filtrate bag hook
4 IV pole and second IV pole (Ci-Ca module option)
5 Potential equalization
6 RS232 screwed connection

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Chapter 3: Installation

Re: 5.3 Leakage current measurement (device leakage current)

Fig.: Differential current measurement according to fig. C.6

Fig.: Direct measurement according to fig. C.5

Basic requirements:
– Measurement of the protective earth resistance performed.
– The system is in standby operating mode (system connected to the
mains).
– The same measurement kit (M28 060 1) as for the patient leakage
current measurement is used for the measurement. Place the
measuring plates on both bag trays and insert the heater bags filled
with NaCl. Measurement setup, see appendix.
– When performing a direct measurement, the following precautions
also must be observed:
The system must be insulated when installed. All external
connections and the potential equalization must have been removed
from the system.

3-10 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 3: Installation

Documentation covers the nominal voltage during the measurement


and the device leakage current at line voltage, scaled to the nominal line
voltage.
Example:
Line voltage during measurement: 225 V
Device leakage current
for mains polarity 1: 38 µA
for mains polarity 2: 57 µA
Maximum value of both mains polarities: 57 µA
Nominal voltage of the power supply: 230 V
Scaled to nominal voltage: 58 µA
(58 µA: 225 V • 230 V = 58 µA)
Device leakage current < 500 µA: OK

Additional conditions:
If the device leakage current is higher than 90 % of the admissible alarm
limit (450 µA), the last measured value or the first measured value must
additionally be considered for the rating.
If the device leakage current considerably increased since the last
measurement or continuously increased since the first measurement
(creeping 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:
Leakage current: 470 µA
Last measured value: 450 A
470 + (470 – 450) = 470 + 20 = 490
OK

Example 2:
Leakage current: 470 µA
Last measured value: 390 µA
470 + (470 – 390) = 470 + 80 = 550
Not passed

Fresenius Medical Care multiFiltrate TM 6/03.07 3-11


Chapter 3: Installation

Re: 5.3 and 5.4 Patient and device leakage current measurement

Fig.: Setup of the measurement kit for measuring the patient leakage
current and the device leakage current

3
4

Legend

1 Saline bag with 0.9 % NaCl solution for heater


2 Measuring plates for bag trays, left and right
3 Heater bag with measuring probe
4 Patient leakage current measurement: "AWT A" connector
Device leakage current measurement: Protective earth terminal
Symbol:

3-12 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 3: Installation

Note on item 3 concerning device leakage measurement


The upper heater bag must be completely filled with NaCl solution so
that the electrode of the measuring probe is situated inside the solution.
Note on item 4 concerning device leakage measurement
The connection line to the measurement kit must be inserted in the
protective earth socket of the SECUTEST unit. If the measuring
instrument fails to provide this arrangement, the connection line must
be connected to a part of the multiFiltrate that is connected to the
protective earth, e.g. the venous clamp.
If the steps are not followed as described, a specific function will be
executed incorrectly or will not be executed at all, or will not produce the
desired effect.

Re: 5.4.1 Patient leakage current measurement for degree of protection (BF)

Degree of protection type BF is applying to systems with ceramic


heater, operated at a line voltage of 220 V to 240 V and at a line
frequency of 60 Hz.

Fig.: Patient leakage current measurement according to figure C.8

Basic requirements:
– Measurement of the protective earth resistance performed.
– The system is in standby operating mode (system connected to the
mains).
– Neither the system nor the test equipment must be touched during
the measurement nor must a cable be connected to the serial
interface.
– The patient leakage current measurement kit (M28 060 1) is used for
the measurement. Place the measuring plates on both bag trays and
insert the heater bags filled with NaCl. Measurement setup, see
appendix.
Documentation covers the nominal voltage during the measurement
and the patient leakage current at line voltage, scaled to the nominal
line voltage.

Fresenius Medical Care multiFiltrate TM 6/03.07 3-13


Chapter 3: Installation

Example:
Measurement value: 48 µA, measured at 225 V
Nominal voltage: 230 V
Scaled to nominal voltage: 49 µA
(48 µA: 225 V x 230 V = 49 µA)

Re: 5.4.2 Patient leakage current measurement for degree of protection (CF)

Degree of protection type CF is applying to systems with ceramic


heater, operated at a line voltage of 100 V to 240 V and at a line
frequency of 50 Hz or at a line voltage of 100 V to 127 V and at a line
frequency of 60 Hz.

Fig.: Patient leakage current measurement according to figure C.8

Basic requirements:
– Measurement of the protective earth resistance performed.
– The system is in standby operating mode (system connected to the
mains).
– Neither the system nor the test equipment must be touched during
the measurement nor must a cable be connected to the serial
interface.
– The patient leakage current measurement kit (M28 060 1) is used for
the measurement. Place the measuring plates on both bag trays and
insert the heater bags filled with NaCl. Measurement setup, see
appendix.
Documentation covers the nominal voltage during the measurement
and the patient leakage current at line voltage, scaled to the nominal
line voltage.
Example:
Measurement value: 28 µA, measured at 244 V
Nominal voltage: 230 V
Scaled to nominal voltage: 26 µA
(28 µA: 244 V x 230 V = 26 µA)

Confirming the test

Test equipment used:


Type and serial number of the test equipment used.

3-14 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 3: Installation

Comments:
Irregularities encountered during the test will be recorded in this section.
Date, signature, stamp
Performance of the test has to be confirmed by indicating date, tester's
signature and stamp.

Assessing the test

The system has been released for its intended use.


(Attach inspection sticker.)
During the intended use of the system it must be ensured that the
system does not present a hazard to patients, employees or other third
parties.
Within the scope of the overall assessment, the tester must make a
definite decision whether the system may be used or not. The
responsible organization must immediately be informed of any defects
detected.
Next inspection date:
The next inspection date has to be entered in the report.
The intervals specified by the manufacturer have to be respected!
Comments:
Irregularities encountered during the assessment will be recorded in
this section.
Date, signature, stamp:
Assessment of the initial start-up has to be confirmed by indicating date,
tester's signature and stamp.

Fresenius Medical Care multiFiltrate TM 6/03.07 3-15


Chapter 3: Installation

3.5 Installing the Ci-Ca Module (Option)

Caution
Before the Ci-Ca module is installed, the power plug of the system must
be disconnected.

The Ci-Ca module is provided with spring pressure pieces, which make
the module click into place at the IV pole on the left side of the
multiFiltrate system. If the securing lever on the rear of the module has
not been unlocked yet, it has to be done before installing the module by
removing the locking screw. The securing lever has to point up when
the module is connected. Place the module onto the lower IV pole
bearing and slide it along the multiFiltrate housing panel, over the action
point of the pressure pieces and onto the IV pole, until the pressure
pieces click into place. Make sure that the electrical connectors easily
slide into each other.

3-16 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 3: Installation

When the module is locked in place at the IV pole, the securing lever
with pressure roll has to be thrown and then secured with the locking
screw so that it cannot be opened. In this case, another action point
must be overcome.

Fresenius Medical Care multiFiltrate TM 6/03.07 3-17


Chapter 3: Installation

3-18 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 4: TSC / TMC / Maintenance

4 TSC / TMC / Maintenance

4.1 Important Information Regarding the Procedure

Tester's qualification The initial start-up must be performed by the Technical Service of
Fresenius Medical Care or a person authorized by them!
The tests may only be performed by persons who are qualified to
properly perform the specified checks owing to their educational
background and training, their knowledge and experience gained in
practice. Furthermore, the persons performing the tests must not be
bound by any directives when performing this activity.

Test equipment and The activities described in this technical document require the
accessories availability of the necessary technical test equipment and accessories.
Any information on the specifications must be observed.

TSC/TMC/MA intervals The TSC/TMC/MA procedures for this system are to be performed after
12 months.

Fresenius Medical Care multiFiltrate TM 6/03.07 4-1


Chapter 4: TSC / TMC / Maintenance

4.2 TSC / MA Report multiFiltrate

Technician's name: System type including option(s) / software version:

Customer/customer no.: System no.: Inventory no.:

Service report number: Operating hours: Equipment code:

Type No. Description Meas.


value

1 Visual inspections

TSC 1.1 Fuses accessible from the outside comply with the indicated values.

TSC 1.2 Labels and labeling are present and legible.

TSC 1.3 The mechanical condition permits further safe use.

TSC 1.4 There are no signs of damage or dirt.

TSC 1.5 The power cable shows no signs of damage.

MA 1.6 Replace the lithium battery of operating and safety processors (P.C.B. LP
244) every 4 years. ________

2 Extracorporeal components

TSC 2.1 Pump checked for stopping with open door.

Blood pump
Filtrate pump
Substituate pump
Dialysate pump

TSC 2.2 Pump rotors checked for damage and rolls for smooth running.

Blood pump
Filtrate pump
Substituate pump
Dialysate pump

TSC 2.3 The venous occlusion clamp closes after an air detector alarm.

TSC 2.4 The pressure of 2 bar applied in the venous bubble catcher may not drop
by more than 0.1 bar within 3 minutes.

4-2 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 4: TSC / TMC / Maintenance

Type No. Description Meas.


value

MA 2.5 Air detector operation/calibration checked.

Jumper J1-P.C.B. LP 450 set to the operation position. Place the checking
block into the air detector. LEDs DI 5 and DI 10 are light.
Jumper J1-P.C.B. LP 450 set to the operation position. Place the adjusting
block into the air detector. LEDs DI 5 and DI 10 are dark.

MA 2.6 Pressure transducers: zero point and amplification as well as tightness


checked.

Arterial pressure (red)


Zero point: Display within the range of ± 5mmHg ________

Amplification: 300Apply 300 mmHg, tolerance ±5 mmHg ________

Tightness: 600 mmHg, drop max. 10 mmHg within 1 min ________

Venous pressure (blue)


Zero point: Display within the range of ± 5mmHg ________

Amplification: 300Apply 300 mmHg, tolerance ±5 mmHg ________

Tightness: 600 mmHg, drop max. 10 mmHg within 1 min ________

PHF pressure (white)


Zero point: Display within the range of ± 5mmHg ________

Amplification: 300Apply 300 mmHg, tolerance ±5 mmHg ________

Tightness: 600 mmHg, drop max. 10 mmHg within 1 min ________

Filtrate pressure (yellow)


Zero point: Display within the range of ± 5mmHg ________

Amplification: 300Apply 300 mmHg, tolerance ±5 mmHg ________

Tightness: 600 mmHg, drop max. 10 mmHg within 1 min ________

MA 2.7 Blood leak detector values checked for red coloration and dimness.

Fresenius Medical Care multiFiltrate TM 6/03.07 4-3


Chapter 4: TSC / TMC / Maintenance

Type No. Description Meas.


value

3 Mechanical components

MA 3.1 Mechanical parts of scales checked for tight seat, parallelism and
smoothness.

Scale I
Scales II
Scales III
Scales IV

MA 3.2 Zero load, calibration and ball weight of scales checked.

Scale I
Zero load: display within a range from 60 g to 4500 g _______g
Calibration: Test load on scales: display 5000 g ±1 g
_______g
Ball weight: display within a range from 43.8 g to 44.8 g
_______g

Scales II
Zero load: display within a range from 60 g to 4500 g _______g
Calibration: Test load on scales: display 5000 g ±1 g
_______g
Ball weight: display within a range from 43.8 g to 44.8 g
_______g

Scales III
Zero load: display within a range from 60 g to 4500 g _______g
Calibration: Test load on scales: display 5000 g ±1 g
_______g
Ball weight: display within a range from 43.8 g to 44.8 g
_______g

Scales IV
Zero load: display within a range from 60 g to 4500 g _______g
Calibration: Test load on scales: display 5000 g ±1 g
_______g
Ball weight: display within a range from 43.8 g to 44.8 g
_______g

MA 3.3 Rotary selector checked for easy movement and tight fit

MA 3.4 Brakes of wheel assy. checked

4-4 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 4: TSC / TMC / Maintenance

Type No. Description Meas.


value

4 Ci-Ca module option: visual inspections

TSC 4.1 Colored markings of drop counters must be present.

TSC 4.2 Adhesive labels of citrate and calcium pumps are present and legible.

TSC 4.3 The mechanical condition permits further safe use.

TSC 4.4 There are no signs of damage or dirt.

TSC 4.5 Line holders must be present and undamaged.

5 Ci-Ca module option: extracorporeal components

TSC 5.1 Citrate drop counter checked for proper function

TSC 5.2 Calcium drop counter checked for proper function

TSC 5.3 Line occlusion of the pumps checked.

Citrate pump (pressure loss max. 10 mmHg/min) ________


Calcium pump (pressure loss max. 10 mmHg/min) ________

Fresenius Medical Care multiFiltrate TM 6/03.07 4-5


Chapter 4: TSC / TMC / Maintenance

Type No. Description Meas.


value

6 Check of the electrical safety


In Germany according to DIN VDE 0751-1, edition 10/2001.
In other countries, observe the local regulations!

TSC 6.1 Visual inspections performed according to item 1.

TSC 6.2 Protective earth resistance max. 0.3 (with power cable) ______

TSC 6.3 Leakage current measurement (device leakage current)


Differential current measurement according to figure C.6
or
Direct measurement according to figure C.5

Nominal voltage of power supply: _______ V

Device leakage current mains polarity 1: _______ ™A

With line voltage: _______ V

Scaled to nominal voltage _____ ™A


(maximum 500 ™A, see Additional conditions)

Device leakage current mains polarity 2: _______ ™A

With line voltage: _______ V

Scaled to nominal voltage _____ ™A


(maximum 500 ™A, see Additional conditions)

TSC 6.4 Patient leakage current measurement

TSC 6.4.1 For degree of protection type "BF" according to fig. C.8

Nominal voltage of power supply: __________ V

Patient leakage current __________ ™A

With line voltage: _______ V

scaled to nominal voltage (maximum 480 ™A, see Additional conditions): _____ ™A

TSC 6.4.2 For degree of protection type "CF" according to fig. C.8

Nominal voltage of power supply: __________ V

Patient leakage current __________ ™A

With line voltage: _______ V

scaled to nominal voltage (maximum 34 ™A, see Additional conditions): _____ ™A

4-6 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 4: TSC / TMC / Maintenance

Type No. Description Meas.


value

7 Functional test

TSC 7.1 Functional test (T1 test) checked for proper performance.

TSC 7.2 Ci-Ca module option


After successful completion of the test, screen M86 'Starting conditions' is
displayed.

TSC 7.3 Power failure alarm executed.

8 Final check

TSC 8.1 Entries made in the Medical Device Register.

Test equipment used:


Pressure
(type, serial number):
________________________________________________________________________________________
Protective earth resistance, leakage current
(type, serial number):
________________________________________________________________________________________

Comments:

Date: Signature: Stamp:

The system has been released for its intended use. Yes
(Attach inspection sticker.)
No

Next
inspection date:

Comments:

Date: Signature: Stamp:

Fresenius Medical Care multiFiltrate TM 6/03.07 4-7


Chapter 4: TSC / TMC / Maintenance

4.3 multiFiltrate TSC Report

Technician's name: System type including option(s) / software version:

Customer/customer no.: System no.: Inventory no.:

Service report number: Operating hours: Equipment code:

Type No. Description Meas.


value

1 Visual inspections

TSC 1.1 Fuses accessible from the outside comply with the indicated values.

TSC 1.2 Labels and labeling are present and legible.

TSC 1.3 The mechanical condition permits further safe use.

TSC 1.4 There are no signs of damage or dirt.

TSC 1.5 The power cable shows no signs of damage.

2 Extracorporeal components

TSC 2.1 Pump checked for stopping with open door.

Blood pump
Filtrate pump
Substituate pump
Dialysate pump

TSC 2.2 Pump rotors checked for damage and rolls for smooth running.

Blood pump
Filtrate pump
Substituate pump
Dialysate pump

TSC 2.3 The venous occlusion clamp closes after an air detector alarm.

TSC 2.4 The pressure of 2 bar applied in the venous bubble catcher may not drop
by more than 0.1 bar within 3 minutes.

4-8 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 4: TSC / TMC / Maintenance

Type No. Description Meas.


value

3 Ci-Ca module option: visual inspections

TSC 3.1 Colored markings of drop counters must be present.

TSC 3.2 Adhesive labels of citrate and calcium pumps are present and legible.

TSC 3.3 The mechanical condition permits further safe use.

TSC 3.4 There are no signs of damage or dirt.

TSC 3.5 Line holders must be present and undamaged.

4 Ci-Ca module option: extracorporeal components

TSC 4.1 Citrate drop counter checked for proper function

TSC 4.2 Calcium drop counter checked for proper function

TSC 4.3 Line occlusion of the pumps checked.

Citrate pump (pressure loss max. 10 mmHg/min) ________


Calcium pump (pressure loss max. 10 mmHg/min) ________

Fresenius Medical Care multiFiltrate TM 6/03.07 4-9


Chapter 4: TSC / TMC / Maintenance

Type No. Description Meas.


value

5 Check of the electrical safety


In Germany according to DIN VDE 0751-1, edition 10/2001.
In other countries, observe the local regulations!

TSC 5.1 Visual inspections performed according to item 1.

TSC 5.2 Protective earth resistance max. 0.3 (with power cable) ______

TSC 5.3 Leakage current measurement (device leakage current)


Differential current measurement according to figure C.6
or
Direct measurement according to figure C.5

Nominal voltage of power supply: _______ V

Device leakage current mains polarity 1: _______ ™A

With line voltage: _______ V

Scaled to nominal voltage _____ ™A


(maximum 500 ™A, see Additional conditions)

Device leakage current mains polarity 2: _______ ™A

With line voltage: _______ V

Scaled to nominal voltage _____ ™A


(maximum 500 ™A, see Additional conditions)

TSC 5.4 Patient leakage current measurement

TSC 5.4.1 For degree of protection type "BF" according to fig. C.8

Nominal voltage of power supply: __________ V

Patient leakage current __________ ™A

With line voltage: _______ V

scaled to nominal voltage (maximum 480 ™A, see Additional conditions): _____ ™A

TSC 5.4.2 For degree of protection type "CF" according to fig. C.8

Nominal voltage of power supply: __________ V

Patient leakage current __________ ™A

With line voltage: _______ V

scaled to nominal voltage (maximum 34 ™A, see Additional conditions): _____ ™A

4-10 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 4: TSC / TMC / Maintenance

Type No. Description Meas.


value

6 Functional test

TSC 6.1 Functional test (T1 test) checked for proper performance.

TSC 6.2 Ci-Ca module option


After successful completion of the test, screen M86 'Starting conditions' is
displayed.

TSC 6.3 Power failure alarm executed.

7 Final check

TSC 7.1 Entries made in the Medical Device Register.

Test equipment used:


Pressure
(type, serial number):
________________________________________________________________________________________
Protective earth resistance, leakage current
(type, serial number):
________________________________________________________________________________________

Comments:

Date: Signature: Stamp:

The system has been released for its intended use. Yes
(Attach inspection sticker.)
No

Next
inspection date:

Comments:

Date: Signature: Stamp:

Fresenius Medical Care multiFiltrate TM 6/03.07 4-11


Chapter 4: TSC / TMC / Maintenance

4.4 Explanations on the TSC / MA Report

Identification

Technician's name:
Technician's first name and surname.
Customer/customer no.:
Number of the final customer.
Service report number:
Number of the service call.
System type including option(s):
System name with possible options and extras.
System no.:
Serial number indicated on the type label.
Inventory no.:
Inventory number assigned to the system.
Operating hours:
Operating hours, if a time meter is installed.
Equipment code:
Equipment code indicated on the system.
(e.g. EC xxx, E-code xxx)

Re: 2 - Extracorporeal components

For detailed information refer to chapter 5 "Adjustment Instructions and


Tests"

Re: 3 - Mechanical components

For more detailed information on item 3.2, please refer to the Quick
Guide on the PC Service Software MFT.

4-12 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 4: TSC / TMC / Maintenance

Re: 4 - Check of the electrical safety

In Germany according to DIN VDE 0751-1, edition 10/2001.


In other countries, observe the local regulations!
(Use DIN VDE 0751-1, edition 10/2001, for medical products. Use DIN
VDE 0701-1 for electrical production equipment.)

Re: 4.2 Protective earth resistance measurement points

5
6

Legend

1 Luer locks
2 Venous clamp
3 Filtrate bag hook
4 IV pole and second IV pole (Ci-Ca module option)
5 Potential equalization
6 RS232 screwed connection

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Chapter 4: TSC / TMC / Maintenance

Re: 4.3 Leakage current measurement (device leakage current)

Fig.: Differential current measurement according to fig. C.6

Fig.: Direct measurement according to fig. C.5

Basic requirements:
– Measurement of the protective earth resistance performed.
– The system is in standby operating mode (system connected to the
mains).
– The same measurement kit (M28 060 1) as for the patient leakage
current measurement is used for the measurement. Place the
measuring plates on both bag trays and insert the heater bags filled
with NaCl. Measurement setup, see appendix.
– When performing a direct measurement, the following precautions
also must be observed:
The system must be insulated when installed. All external
connections and the potential equalization must have been removed
from the system.

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Chapter 4: TSC / TMC / Maintenance

Documentation covers the nominal voltage during the measurement


and the device leakage current at line voltage, scaled to the nominal line
voltage.
Example:
Line voltage during measurement: 225 V
Device leakage current
for mains polarity 1: 38 µA
for mains polarity 2: 57 µA
Maximum value of both mains polarities: 57 µA
Nominal voltage of the power supply: 230 V
Scaled to nominal voltage: 58 µA
(58 µA: 225 V • 230 V = 58 µA)
Device leakage current < 500 µA: OK

Additional conditions:
If the device leakage current is higher than 90 % of the admissible alarm
limit (450 µA), the last measured value or the first measured value must
additionally be considered for the rating.
If the device leakage current considerably increased since the last
measurement or continuously increased since the first measurement
(creeping 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:
Leakage current: 470 µA
Last measured value: 450 A
470 + (470 – 450) = 470 + 20 = 490
OK

Example 2:
Leakage current: 470 µA
Last measured value: 390 µA
470 + (470 – 390) = 470 + 80 = 550
Not passed

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Chapter 4: TSC / TMC / Maintenance

Re: 4.3 and 4.4 Patient and device leakage current measurement

Fig.: Setup of the measurement kit for measuring the patient leakage
current and the device leakage current

3
4

Legend

1 Saline bag with 0.9 % NaCl solution for heater


2 Measuring plates for bag trays, left and right
3 Heater bag with measuring probe
4 Patient leakage current measurement: "AWT A" connector
Device leakage current measurement: Protective earth terminal
Symbol:

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Chapter 4: TSC / TMC / Maintenance

Note on item 3 concerning device leakage measurement


The upper heater bag must be completely filled with NaCl solution so
that the electrode of the measuring probe is situated inside the solution.
Note on item 4 concerning device leakage measurement
The connection line to the measurement kit must be inserted in the
protective earth socket of the SECUTEST unit. If the measuring
instrument fails to provide this arrangement, the connection line must
be connected to a part of the multiFiltrate that is connected to the
protective earth, e.g. the venous clamp.
If the steps are not followed as described, a specific function will be
executed incorrectly or will not be executed at all, or will not produce the
desired effect.

Re: 4.4.1 - Patient leakage current measurement for degree of protection (BF)

Degree of protection type BF is applying to systems with ceramic


heater, operated at a line voltage of 220 V to 240 V and at a line
frequency of 60 Hz.

Fig.: Patient leakage current measurement according to figure C.8

Basic requirements:
– Measurement of the protective earth resistance performed.
– The system is in standby operating mode (system connected to the
mains).
– Neither the system nor the test equipment must be touched during
the measurement nor must a cable be connected to the serial
interface.
– The patient leakage current measurement kit (M28 060 1) is used for
the measurement. Place the measuring plates on both bag trays and
insert the heater bags filled with NaCl. Measurement setup, see
appendix.
Documentation covers the nominal voltage during the measurement
and the patient leakage current at line voltage, scaled to the nominal
line voltage.

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Chapter 4: TSC / TMC / Maintenance

Example:
Measurement value: 48 µA, measured at 225 V
Nominal voltage: 230 V
Scaled to nominal voltage: 49 µA
(48 µA: 225 V x 230 V = 49 µA)

Re: 4.4.2 Patient leakage current measurement for degree of protection (CF)

Degree of protection type CF is applying to systems with ceramic


heater, operated at a line voltage of 100 V to 240 V and at a line
frequency of 50 Hz or at a line voltage of 100 V to 127 V and at a line
frequency of 60 Hz.

Fig.: Patient leakage current measurement according to figure C.8

Basic requirements:
– Measurement of the protective earth resistance performed.
– The system is in standby operating mode (system connected to the
mains).
– Neither the system nor the test equipment must be touched during
the measurement nor must a cable be connected to the serial
interface.
– The patient leakage current measurement kit (M28 060 1) is used for
the measurement. Place the measuring plates on both bag trays and
insert the heater bags filled with NaCl. Measurement setup, see
appendix.
Documentation covers the nominal voltage during the measurement
and the patient leakage current at line voltage, scaled to the nominal
line voltage.
Example:
Measurement value: 28 µA, measured at 244 V
Nominal voltage: 230 V
Scaled to nominal voltage: 26 µA
(28 µA: 244 V x 230 V = 26 µA)

Confirming the test

Test equipment used:


Type and serial number of the test equipment used.

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Chapter 4: TSC / TMC / Maintenance

Comments:
Irregularities encountered during the test will be recorded in this section.
Date, signature, stamp
Performance of the test has to be confirmed by indicating date, tester's
signature and stamp.

Assessing the test

The system has been released for its intended use.


(Attach inspection sticker.)
During the intended use of the system it must be ensured that the
system does not present a hazard to patients, employees or other third
parties.
Within the scope of the overall assessment, the tester must make a
definite decision whether the system may be used or not. The
responsible organization must immediately be informed of any defects
detected.
Next inspection date:
The next inspection date has to be entered in the report.
The intervals specified by the manufacturer have to be respected!
Comments:
Irregularities encountered during the assessment will be recorded in
this section.
Date, signature, stamp:
Assessment of the initial start-up has to be confirmed by indicating date,
tester's signature and stamp.

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Chapter 4: TSC / TMC / Maintenance

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Chapter 5: Adjustment Instructions and Tests

5 Adjustment Instructions and Tests

5.1 Service Tools

Part no. Description

M28 489 1 Dongle ICD cable for programming the OP and SP

M28 060 1 Measuring kit for measuring the patient leakage


current

M28 098 1 Crosstalk Reduction Adapter

510 130 1 ESC tester with measuring adapter for patient leakage
current

M30 770 1 HMED pressure measuring instrument with case (set)

631 064 1 Secutest VDE test device (without printer module)

630 652 1 Printer module for secutest

630 648 1 Carrying bag for secutest

630 387 1 ESD Service Kit

670 004 1 Multimeter Fluke 75

M28 486 1 RS232 null-modem cable, 9-pin D-SUB

M28 487 1 Gender Changer connector – connector, 9-pin D-SUB

M28 488 1 Connector–socket extension, 1.5 m, 25-pin D-SUB

M28 497 1 CD-ROM with programming software for ICD dongle


for programming the OP and SP

M36 234 1 Service Software, complete set


(incl. card reader, null-modem cable, Gender
Changer)

M36 235 1 Service Software, software set without hardware

M28 498 1 Square wrench, housing door

675 845 1 Hook test weight 5 kg / M1

630 360 1 Equipotential bonding cable

M36 067 1 Calibration kit for air detector

640 560 1 Neutral filter for calibrating the optical detector

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Chapter 5: Adjustment Instructions and Tests

5.2 Service Program

5.2.1 Start

The system must be turned off via I/O. The power switch on the rear of
the system must be turned on.
– Press and hold the Start/Reset key. Simultaneously press the I/O
until the yellow status indicator lights up.

– Using the rotary selector, select the numerical code and confirm
each number by pressing the OK key.

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Chapter 5: Adjustment Instructions and Tests

After the password has been checked positively, all revisions are
displayed to the left of the screen. The menu fields of the Service
program are displayed to the right of the screen.
– Use the rotary selector to select the desired menu field and press
OK.

5.2.2 Selecting the Language

– Use the rotary selector to select the desired language and press OK.
– Turn off the system via the I/O key immediately thereafter.
– Once again turn on the system via the I/O key and restart the Service
program.

5.2.3 System Messages

Only the error messages (E XX) and warnings (W XX) of the previous
treatments are filtered out of the events memory (see below) and
displayed on the screen.

5.2.4 Deactivating and Activating the Heparin Pump

Permits activation and deactivation of the optional heparin syringe.

Screen display Machine status

Deactivate heparin syringe The heparin syringe is currently


active.

Activate heparin syringe The heparin syringe is currently


not active.

Note
If the system does not contain any installed heparin syringe, the
machine status should be set to Heparin syringe currently not active.
If the setting fails to reflect the proper machine status, a warning is
displayed during the T1 test.

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Chapter 5: Adjustment Instructions and Tests

5.2.5 Filtrate Bag Monitoring Limit

Permits to set the monitoring limit to a value between 10 kg and 20 kg


on the filtrate scales.

Screen display Machine status

Filtrate bag max. 5 kg Currently, the monitoring limit is


set to 5 kg.

Filtrate bag max. 10 kg Currently, the monitoring limit is


set to 10 kg.

Filtrate bag max. 20 kg Currently, the monitoring limit is


set to 20 kg.

5.2.6 Dialysate Tubing Arrangement

Permits to switch from old to "Fin" dialysate tubing arrangement and


vice versa in the preparation mode.

old Tubing system with heater bag downstream of the pump segment

"Fin" Tubing system with heater bag upstream of the pump segment

Screen display Machine status

Tubing arrangement dialysate Display of the old tubing


old arrangement. Heater bag for
dialysate downstream of the
dialysate pump.

Tubing arrangement dialysate Display of the new tubing


"Fin" arrangement. Heater bag for
dialysate upstream of the
dialysate pump.

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Chapter 5: Adjustment Instructions and Tests

5.2.7 Option MultiDataLink (mDL)

This screen permits to set the multiDataLink parameters.

Activating and This soft key permits activation and deactivation of the optional mDL.
deactivating mDL
Screen display Machine status

Deactivate mDL mDL is currently active.

Activate mDL mDL is currently not active.

Note
If the system does not contain any installed mDL, the machine status
should be set to mDL currently not active. If the setting fails to reflect
the proper machine status, a warning is displayed during the T1 test.

DHCP active / inactive This soft key informs the mDL of whether a DHCP server is active in the
connected network. If this is the case, the mDL receives its IP
addresses from this server. If no, the IP addresses must be set
manually.

DHCP active DHCP inactive

mDL-IP-address Automatic 0...255 adjustable

mDL-IP-subnet Automatic 0...255 adjustable

Gateway-address Automatic 0...255 adjustable

Server-IP-address Automatic 0...255 adjustable

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Chapter 5: Adjustment Instructions and Tests

DHCP active DHCP inactive

Server-port 0...65535 adjustable 0...65535 adjustable


Default value: 700 Default value: 700

Host-port 0...65535 adjustable 0...65535 adjustable


Default value: 2512 Default value: 2512

Technician's port 0...65535 adjustable 0...65535 adjustable


Default value: 2511 Default value: 2511

Note
Before setting the mDL parameters, please clarify with the responsible
hospital network administrator whether a DHCP server is available for
automatically assigning the IP addresses. If no, the administrator has to
specify defined addresses which will then have to be entered manually.
The port numbers depend on the application which further processes
the multiFiltrate data. The administrator of this software will have to
specify the appropriate values if these are different from default values.

– Use the rotary selector to select the Terminate? [OK] to confirm!


field and press OK.

Activating/deactivating the This soft key permits activation and deactivation of the optional
Patient/Case ID patient/case ID.

Screen display Machine status

Deactivate patient/case ID The patient/case ID is currently


active

Activate patient/case ID The patient/case ID is currently


not active

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Chapter 5: Adjustment Instructions and Tests

5.2.8 Taring and Calibrating the Scales

The screen displays the zero load weights of the scales 1 to 4. Upon
start of the Service program, the scales are not tared. Hence, a display
value within a range from 2500 g to 3500 g is expected for scales 1 and
2. A display value within a range from 250 g to 350 g is expected for
scales 3 and 4. Each of the scales (1 to 4) is provided with its own menu
field for taring and calibrating purposes. The tare and calibrate
procedures are described by the example of scale 1. The same
procedures apply to scales 2 to 4.

Taring the scales

Requirement The system must be turned on via I/O for at least 5 minutes to bring the
scales to operating temperature.
– Using the rotary selector, select the Tare field under Scale I and
press OK.

While taring is in progress, the field selected is represented light-green.


After a time out of approx. 10 seconds, the weight of the scale is
indicated to be 0 g.

Calibrates the scales

Test equipment Test weight of 5000 g of accuracy class M1 or better.

Requirement The scales must be unloaded!


Tubing sets may not be inserted.
The scales must have been tared beforehand.

Each scale must be tared separately!

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Chapter 5: Adjustment Instructions and Tests

– To calibrate the scales 1 and 2, place the test weight centrally on the
rear part of the scale pan.
– To calibrate the scales 3 and 4, suspend the test weight from a hook.
– Use the rotary selector to select the Calibrate field of the loaded
scale and press OK.
While calibration is in progress, the field selected is represented light-
green. The time out is approx. 10 seconds.

5.2.9 Calibrating the Pressures

The menu fields for calibration of the pressures (arterial, venous,


prehemofilter and filtrate) are displayed to the right of the screen.
Performance of the calibration procedure of the pressure transducers is
described by example of the arterial pressure. The three other
pressures are calibrated in the same manner.

Zero offset of pressure transducers

Requirement The pressure transducers must have ambient pressure (pressure


transducers open).
– Use the rotary selector to select the P arterial field and press OK.

– Use the rotary selector to select the Pressure sensor open? ”OK”
to confirm! field and press OK.

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Chapter 5: Adjustment Instructions and Tests

The zero offset is made automatically. It is completed when the next


screen is displayed.

Calibrating the pressure transducers

Test equipment Pressure gauge with a measurement range from 0–350 mmHg
(0–500 mbar), disposable syringe, artery forceps

Measuring instrument

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Chapter 5: Adjustment Instructions and Tests

– Connect the measuring instrument to the pressure transducer.


– Using the syringe, build up a pressure of 300 mmHg. (tolerance
•50 mmHg) Then, using the artery forceps, occlude to the direction
of the syringe so that the pressure transducer and the pressure
gauge are still under load.
– Using the rotary selector, set the value indicated by the pressure
gauge on the screen, i.e. in the Parterial field.
– Use the rotary selector to select the Entered? ”OK” to confirm!
field and press OK.
After calibration is completed, the system returns to the previous
screen.

Determining the setting of the DAC for detuning in the self-test

Requirement The pressure transducers must have ambient pressure.

– Use the rotary selector to select the Pressure sensor open? ”OK”
to confirm! field and press OK.
While the self-test is in progress, the field selected is represented light-
green. The time out is approx. 10 seconds.

Note
If an error occurs during calibration, check and, if necessary, calibrate
the corresponding evaluation board (P.C.B. LP 450-3 or P.C.B. LP 343-
1).

5.2.10 Calibrating the Blood Leak Detector

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Chapter 5: Adjustment Instructions and Tests

Test equipment Filtrate line filled with water.


– Insert the water-filled filtrate line into the BLD measuring head.
– Use the rotary selector to select the Tubing inserted? ”OK” to
confirm! field and press OK.
After completion of the calibration procedure, the message
”Calibration complete. Press ESC to continue.” is displayed.
– Press the ESC key.

5.2.11 Verifying the System Values

– Use the rotary selector to select Verify system values and press
OK.

Using this service step, all relevant parameters as well as the function
of the pumps, pressure transducers and scales can be verified.
Press the Start/Reset key to activate the heater.

Caution
If heater bags are not inserted and if there is no fluid in the system, the
heater will become very hot.

Ci-Ca module (option) Citrate and calcium pump can be limitedly be activated in this menu.
– Press the STOP key.
The pumps stop
– Press the START/RESET key
The pumps start running at a delivery rate of 500ml/h if the
insertion switch is pressed (tubing inserted)

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Chapter 5: Adjustment Instructions and Tests

Display of pressure values (venous, PHF, arterial, and filtrate);


resolution 1 mmHg. With open pressure transducers, the display must
show values within a range from – 5 mmHg to 5 mmHg.

Display of weights (scale 1, scale 2, scale 3, and scale 4); resolution


1 g.

Display of the temperatures of the heaters for the sensors of the


operating processor (OP) and the safety processor (SP).

Screen Heater location

Sub. temp. Bag Lower heater, bag sensor

Sub. temp. Foil Lower heater, foil sensor

Dial. temp. Bag Upper heater, bag sensor

Dial. temp. Foil Upper heater, foil sensor

Display of system voltages. This display is only intended for a rough


check of the system voltages. Owing to the hardware and software
conversions, the accuracy is within a range of ±5% only. Use a
calibrated multimeter to perform a check for the indicated range directly
on P.C.B. LP 124 or LP 244 SR/BR (SP/OP).

Screen Desired value Voltage

Voltage +5 V 5.0 - 5.3 V Logic voltage

Voltage 11.5 - 12.3 V Supply voltage


+12 V

Voltage - -(11.2 - 12.3 V) Supply voltage


12 V

Voltage 23.0 - 24.0 V Supply voltage


+24 V

Voltage +5 V 5.05 - 4.95 V Supply voltage of the operating


ref. OS processor for the A-D converter

Voltage +5 V 5.05 - 4.95 V Supply voltage of the safety


ref. SS processor for the A-D converter

Battery 18.0 - 22.5 V Battery terminal voltage


voltage

The housing temperatures are determined by means of the sensors of


the scales. These sensors transmit their values to the safety processor.

Screen Temperature

Housing Upper temp. Mean value of the sensors of the


two upper scales

Housing Lower temp. Mean value of the sensors of the


two lower scales

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Chapter 5: Adjustment Instructions and Tests

Specified pump rates. Opposed to the entries made during the


treatment, all specified values must be entered in ml/min. With the
exception of the door-open state, the pumps are not monitored during
the Service program.

Screen Delivery rate

Blood pump 10 – 500 ml/min

Filtrate pump 10 – 200 ml/min

Substituate pump 10 – 200 ml/min

Dialysate pump 10 – 200 ml/min

5.2.12 Events Memory

To permit analysis and reproducibility of objected states occurring once


in the display processor, the events of the previous treatments (from the
view of the display processor) are recorded together with the moment
of occurrence and are stored in a file when the system is turned off with
I/O. At the beginning of the treatment, the date is additionally stored.
– Turn the rotary selector to the right to scroll down and to the left to
scroll up screen by screen.

Screen Delivery rate

Mxx Menu no. xx

>Fx Move to the xth foot bar key

Fx> Selection of the xth foot bar key with OK

YYYYY Treatment mode

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Chapter 5: Adjustment Instructions and Tests

Screen Delivery rate

y Internal operating mode

Hxx Display of note no. xx

Wxxx Display of warning no. xxx

Exxx Display of error no. xxx

H0 Hiding of the respective display

->x Turn right by x steps before function key

<-4 Turn left by x steps before function key

.->x Turn by x steps took place before a preceding H, W or


F entry (in M61 only).

Oxx Internal options command

BRxx Blood flow in ml/min

ARxxxx Substituate rate in ml/h; plasma rate in ml/min

DRxxxx Dialysate rate in ml/h

SVxxxx Plasma volume in ml

EExxxx Ultrafiltration in ml/h

UZxxxx UF goal in ml/h

TSxx Temperature in 0.1 ”C

ABxx Bolus anticoagulation in 0.1 ml

KA Continuous anticoagulation in 0.1 ml/h

SPVxxxx Rinse volume in ml

UFVxxxx UF volume in ml

RIVxxxx Reinfusion volume in ml

DHxxx Display brightness in %

LSxxx Volume of audible alarm in %

SCxxx Pressure in mmHg

AHxxx Upper arterial pressure limit in mmHg

ALxxx Lower arterial pressure limit in mmHg

VHxxx Upper venous pressure limit in mmHg

VLxxx Lower venous pressure limit in mmHg

THxxx Upper TMP/pF pressure limit in mmHg

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Chapter 5: Adjustment Instructions and Tests

Screen Delivery rate

TLxxx Lower TMP/pF pressure limit in mmHg

DCx Pressure limit alteration code


Art. size = 1; art. position = 4
Ven. size =2; ven. position =5
TMP/UF size = 3; TMP/UF position = 6

!!....Z.xx:x Internal program run observations

Legend

x Numerical character
y Lower-case letter
Y Upper-case character

5.2.13 Program Treatment Modes

Using this menu, the treatment types can be programmed in the order
as they are used most frequently, while those treatment types that are
not desired can be hidden.
– Use the rotary selector to select the desired treatment modes and
press [OK].
– Turn off the system via the I/O key immediately thereafter.
– Once again turn on the system via the I/O key and restart the Service
program.

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Chapter 5: Adjustment Instructions and Tests

Note
The selected treatment modes remain active only if you turn the system
off and back on again immediately after terminating the selection.

5.2.14 Programming the Ci-Ca Data (Option)

All settings relevant for the Ci-Ca treatment are performed in this menu.
– Use the rotary selector to select the desired field and press [OK].
– Use the rotary selector to enter the desired value and press [OK].

Note
To reduce the risk of using the wrong citrate or calcium containers, only
one type of container (container size and concentration) should be used
throughout the hospital or a comparable organization institution. Save
the same settings for citrate and calcium containers in the setup of all
multiFiltrate systems of this organization institution.

Ci-Ca settings min. max. Resolution Unit

Citrate solution conc. 50 500 1 mmol/l

Calcium solution conc. 50 500 1 mmol/l

Citrate solution volume 100 2000 10 ml

Calcium solution volume 100 2000 10 ml

Number of Citrate bags 1 1 1 pc.

Number of Ca bags 1 1 1 pc.

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Chapter 5: Adjustment Instructions and Tests

5.3 Extracorporeal Components

Note
Carry out all steps described below in the Service program.

5.3.1 Tightness of the Venous Occlusion Clamp

Measurement setup

Test equipment Pressure gauge, disposable syringe, venous tubing system with
occlusion clamp or artery forceps or test tubing, stop watch
– With the open line end in front, insert the measuring instrument into
the venous occlusion clamp.
– Using the syringe, build up a pressure of 2 bar. Then, using the
artery forceps, occlude to the direction of the syringe so that the
pressure gauge is still under load.
– Start the stop watch. After 3 minutes have elapsed, the pressure
applied may not drop by more than 0.1 bar.

5.3.2 Checking the Pressure Transducers

Zero point Check the pressure transducers in the Service program in the Check
system values menu item. With open pressure transducers, the
pressures displayed must be within a range from –5 mmHg to
+5 mmHg.

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Chapter 5: Adjustment Instructions and Tests

Measurement setup

Amplification – Connect the measuring instrument to the pressure transducer.


– Using the syringe, build up a pressure of 300 mmHg •20 mmHg.
Then, using the artery forceps, occlude to the direction of the syringe
so that the pressure transducer and the pressure gauge are still
under load.
– The value displayed on the screen must be identical with the value
indicated by the pressure gauge. Tolerances: •5 mmHg.

Leakage – Connect the measuring instrument to the pressure transducer.


– Using the syringe, build up a pressure of 600 mmHg. Then, using the
artery forceps, occlude to the direction of the syringe so that the
pressure transducer and the pressure gauge are still under load.
– Start the stop watch. After one minute has elapsed, the pressure
applied may not drop by more than 10 mmHg.

5.3.3 Venous Pressure Transducer (P.C.B. LP 450-3)

Usually, the pressure board LP 450-3 has been precalibrated.


Whenever the printed circuit board is replaced, the zero point must be
set. The amplification must be checked and readjusted, if necessary.

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Chapter 5: Adjustment Instructions and Tests

Fig.: P.C. B. LP 450-3, no SMT

P3 P1 P2 P4 P5 DI 5 DI 10

Jumper J1

MP3
MP2

Fig.: P.C.B. LP450-3, SMT

P1 P2 P3 P4 P5 MP3 MP2

DI 5

DI 10

Jumper J1

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Chapter 5: Adjustment Instructions and Tests

Setting the zero point Setting the zero point with open pressure transducers.
– Connect the negative pole of the multimeter to MP3 (0 V).
– Connect the positive pole of the multimeter to MP2.
– Use the potentiometer P3 to set the following voltage.

Pressure transducer Voltage

Venous 3 V •0.2 V

Setting the amplification For verification and setting purposes, apply a pressure of 300 mmHg
•20 mmHg to the pressure transducers.
– Use the potentiometer P4 to set the following voltage.

Pressure transducer Voltage

Venous 5.9 V •0.2 V

Note
Whenever the P.C.B. LP 450-3 is replaced, the air detector must be
recalibrated.

5.3.4 Air Detector (P.C.B. LP 450-3)

Test equipment Adjusting block and checking (reference) block M36 067 1

Check using the checking – Set the jumper J1 / P.C.B. LP 450-3 to the ”operation” position
block (red) (NORM OP).
– Fill the spherical recesses of the checking block with grease and
remove any excess grease so that only the recesses themselves will
be struck with grease.
– Place the greased checking block into the drip chamber holder. It
must be ensured that the ultrasonic sensors must correctly click into
place into the spherical recesses of the adjusting block. The block
must not touch the holder wall, but must hang freely between the
sensors.
Desired function: The LEDs DI 5 and DI 10 on the P.C.B. LP 450-3 are
light.
If the desired function fails to be fulfilled, the ultrasonic detector must be
set.

Check using the adjusting – Set the jumper J1 / P.C.B. LP 450-3 to the ”operation” position
block (grey) (NORM OP).
– Fill the spherical recesses of the adjusting block with grease and
remove any excess grease so that only the recesses themselves will
be struck with grease.
– Place the greased adjusting block into the drip chamber holder. It
must be ensured that the ultrasonic sensors must correctly click into
place into the spherical recesses of the adjusting block. The block
must not touch the holder wall, but must hang freely between the
sensors.

5-20 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 5: Adjustment Instructions and Tests

Desired function: The LEDs DI 5 and DI 10 on the P.C.B. LP 450-3 are


dark.
If the desired function fails to be fulfilled, the ultrasonic detector must be
set.
– Take the adjusting block out of the drip chamber holder and
completely remove the grease from the drip chamber holder, only
using non-pilling fabric and disinfectants authorized for this purpose.

Calibration – Set the jumper J1 / P.C.B. LP 450-3 to the ”calibration” position


(CALIB).
– Fill the spherical recesses of the adjusting block with grease and
remove any excess grease so that only the recesses themselves will
be struck with grease.
– Place the greased adjusting block into the drip chamber holder. It
must be ensured that the ultrasonic sensors must correctly click into
place into the spherical recesses of the adjusting block. The block
must not touch the holder wall, but must hang freely between the
sensors.
– Turn potentiometer 1 and then potentiometer 2 on P.C.B. LP 450-3
until the LEDs DI 5 and DI 10 on P.C.B. LP 450-3 are dark.
– Slowly (caution: time constant) turn potentiometer 1 / P.C.B. LP 450-
3 back until the LED DI 5 on P.C.B. LP 450-3 lights.
– Slowly (caution: time constant) turn potentiometer 2 / P.C.B. LP 450-
3 back until the LED DI 10 on P.C.B. LP 450-3 lights.
– Set the jumper J1 / P.C.B. LP 450-3 to the ”operation” position
(NORM OP).
Desired function: The LEDs DI 5 and DI 10 on the P.C.B. LP 450-3 are
dark.
– Take the adjusting block out of the drip chamber holder and
completely remove the grease from the drip chamber holder, only
using non-pilling fabric and disinfectants authorized for this purpose.

5.3.5 Optical Detector Sensing Opaque / Non-Opaque Fluid (P.C.B. LP 450-3)

Calibration – Start the Service program and select "Verify system values".
– Hold the neutral filter (640 560 1) (to be used in 2 layers) into the
optical detector. Close the flap to minimize external light.
– Slowly turn the potentiometer P5 on P.C.B. LP 450-3 until the
audible signal turns silent.
– Slowly turn potentiometer P5 until the audible signal is sounded.
Then turn it for another half-revolution.

5.3.6 Arterial / Filtrate / PHF Pressure Transducers (P.C.B. LP 343-1)

Usually, the pressure boards LP 343-1 have been precalibrated.


Whenever the printed circuit boards are replaced, the zero point must
be set. The amplification must be checked and readjusted, if necessary.

Fresenius Medical Care multiFiltrate TM 6/03.07 5-21


Chapter 5: Adjustment Instructions and Tests

MP31 R24 R25

Setting the zero point Setting the zero point with open pressure transducers.
– Connect the negative pole of the multimeter to the shield connection
of a jack connector.
– Connect the positive pole of the multimeter to MP31.
– Use the potentiometer R24 to set the following voltage.

Pressure transducer Voltage

Arterial, filtrate 5 V •0.2 V

PHF 2 V •0.2 V

Setting the amplification For verification and setting purposes, apply a pressure of 300 mmHg
•20 mmHg to the pressure transducers (see Measuring instrument,
chapter 5.1.9, Calibrating the Pressures).
– Use the potentiometer R25 to set the following voltage.

Pressure transducer Voltage

Arterial, filtrate 7.9 V •0.2 V

PHF 4.9 V •0.2 V

5.3.7 Blood Leak Detector

System requirements PC with Service Software MFT M36 235 1


with null-modem cable M36 234 1

Checking red coloration – Via PC with Service Software MFT


and dimness

Calibrate – A filtrate tubing set filled with water must be inserted in the BLD
measuring head.
– Via PC with Service Software MFT

5-22 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 5: Adjustment Instructions and Tests

5.3.8 Setting the Heparin Pump

In case of a data loss, the heparin pump must be reinitialized to redefine


the end points.

Initialization

After turning the system on, the heparin pump will be initialized by
moving the slide carriage up and down once, using the two control keys.

Press and hold the corresponding key during the up and down
movement. The end points are defined after completion of the
initialization.

Hex coding switch

Hex Syringe type


coding

0 Type: 50 ml Fresenius P syringe

1 Type: 30 ml Fresenius Medical Care heparin syringe

2 Type: 50 ml Fresenius Injectomat syringe

The Hex codings 3 F are not used.


A wrong Hex coding will result in an error message.

Fresenius Medical Care multiFiltrate TM 6/03.07 5-23


Chapter 5: Adjustment Instructions and Tests

5-24 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 5: Adjustment Instructions and Tests

5.4 Programming the Processors

Directory tree Path C:\MFT\Software must be created. The subordinate paths are
created automatically.
The Word file "System_Configuration_**.doc“ contains information on
the modifications of the respective software version.
Light (green) paths must be created
Dark (blue) paths are created automatically

'@1*8

7SJX[EVI

:C<<<

7]WXIQC/SRJMKYVEXMSRCIRHSG
7]WXIQC/SRJMKYVEXMSRCHIHSG

&SSXC(MWOC>Q

&V ,SWX

%1&;4
FV <<<W

(V
&SSX

>Q0F
1JX\\\I\I &SSX0FF
>Q0F
1JX\\\I\I
>Q0F
1JX\\\I\I
>Q0F

1JX\\\I\I

7V

%1&;4
WV<<<W

>Q

4VGSQ
4VGSQ
8VERWJIV '31
8VERWJIV '31
>1FEX
>1FEX
>6'31I\I

Fresenius Medical Care multiFiltrate TM 6/03.07 5-25


Chapter 5: Adjustment Instructions and Tests

5.4.1 Display Processor (DP)

Note
In case of an update of the display processor the preset system
parameters will be lost. The have to be saved via the Service Software
and then reinstalled on the display processor of the multiFiltrate.
After an update, the mDL parameters, the parameters for language,
filtrate bag monitoring and heparin pump activation and the settings for
Ci-Ca treatments must be checked and, if necessary, readjusted.

System requirements PC with Service Software MFT M36 235 1

Procedure – Via PC with Service Software MFT

5.4.2 Operating and Safety Processors (OP and SP)

System requirements PC/laptop with flash software PROG16-68HC16 program,


25-pin D-SUB interface cable (M28 488),
Use a dongle ICD cable (M28 489), if necessary a cross protection
adapter; software for OP / SP is saved under the folder structure on the
PC.

Preparation

The system is disconnected from external power supply (on the rear).
– Open the rear wall of the system housing.

5-26 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 5: Adjustment Instructions and Tests

– Connect the interface cable to the parallel port (LPT1) of the PC and
the other end to the dongle ICD cable. If necessary, use the cross
protection adapter.
– Fit the 10-pin ribbon cable socket of the dongle onto the processor
board to be programmed.

Procedure (identical for both OP and SP)

– Turn on the system using the power switch (on the rear).
– Start the PROG16-68HC16 program on the PC.

Note
After having turned the multiFiltrate on, avoid waiting too long until
starting the program because, otherwise, the battery will be loaded for
an unnecessarily long period.

– Confirm the Connection Assistant with OK.

Fresenius Medical Care multiFiltrate TM 6/03.07 5-27


Chapter 5: Adjustment Instructions and Tests

– Select the directory of the connected processor board (BR (OP) or


SR (SP)), select the file AM9200bw.16p and click Öffnen (Open).

– Enter 0 in the "Base Address?" window and click OK.

– Click the diskette symbol in the function bar or call up SS Specify S


record by double-clicking the pertinent line in the left-hand window.

5-28 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 5: Adjustment Instructions and Tests

– Select the file name (e.g. sr-x.xx.s2) of the new software in the BR
(OP) / SR (SP) directory, and confirm by pressing the ENTER key or
clicking the Öffnen (Open) button.

Note
Enter the "*.*" file name and display the files by clicking the Öffnen
(Open) button. Select the desired file using the cursor and apply it by
pressing the Enter key or clicking the Öffnen (Open) button.

Erasing the Flash – Click the eraser symbol in the function bar, or call up EM Erase
module by double-clicking the pertinent line in the left-hand window.
The status window displays the process. Once the process is
completed, the message Module has been erased is emitted.

Programming the Flash – Click the lightning symbol in the function bar, or call up PM
Program module by double-clicking the pertinent line in the left-
hand window.
This process is displayed in the status window. The addresses are
incremented $xxxxx. At the end of the program, Programmed is
displayed.
– To exit the menu, click the closing symbol (X), or select FILE and
Exit (ALT-X) from the menu bar.

Fresenius Medical Care multiFiltrate TM 6/03.07 5-29


Chapter 5: Adjustment Instructions and Tests

Completion

– Turn off the system using the power switch on the rear.
– Remove the 10-pin ribbon cable socket of the dongle of the printed
circuit board.

5.4.3 Interchangeability of Safety and Operating Processor

Safety and operating processor are electrically identical.

Although their software versions are having the same number (e. g.
1.51), they differ by the stored program code and by the saved data.

At the factory, the processors with the respective programming are


identified by the labels "SR" (SP) and "BR" (OP).

Note

In exceptional cases an operating processor may be used as safety


processor (or vice versa). The following must be observed:

Using an operating processor (OP) as a safety processor (SP)

– Erase the flash as described above and then program it using the
"SR-x.xx.S2" software (SR = SP).
– Check: Jumper J7 must be connected.
– Turn off the system using the power switch.
– Turn on the system using the power switch.
– Press ESC and I/O to turn the system on (initialization).
– Turn the system off after several seconds.
– Turn the system on in the Service mode (I/O and Start).
– Calibration of the blood leak detector.
– Turn the system off after several seconds.

Using a safety processor (SP) as an operating processor (OP)

– Erase the flash as described above and then program it using the
"BR-x.xx.S2" software (BR = OP).
– Check: Jumper J7 must not be connected.
– Turn off the system using the power switch.
– Turn on the system using the power switch.
– Press ESC and I/O to turn the system on (initialization).
– Turn the system off after several seconds.
– Turn the system on in the Service mode (I/O and Start).
– Calibration of all pressures (TM 5.1.9)
– Calibration and taring of all scales (TM 5.1.8)
The correct weight will be displayed only after having saved "5 kg".
– Enter date, time, serial number and EC-code.

5-30 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 5: Adjustment Instructions and Tests

As a rule, the following steps then have to be performed:

– T1 test
– selection of a new treatment mode (once).
– correct identification on the printed circuit board (BR (OP) or SR
(SP)).

5.5 Ci-Ca Module (Option)

Note
In case of a failure of the Ci-Ca module, the entire module is replaced.
The module is not directly repaired on site.

5.5.1 Preparing the Functional Test

The functional test of the components of the Ci-Ca module is performed


in the treatment mode of the basic system.
– Turn the system on in the treatment mode.
– Start the functional test.
– Turn on the Ci-Ca anticoagulation.
– Select the CVVHD treatment mode.
– Put a 5 kg weight on the scale 1 or 2.
– Insert a filled dummy in the air detector.

– Insert a shunted pump tube segment with


drip chamber into the citrate and calcium
pump.

– Use the rotary selector to select Set up? [OK] to confirm! and
press [OK].
– Use the rotary selector to select all messages during preparation
(status line is blue) up to the message Start connection? [OK] to
confirm! and confirm them by pressing [OK].
– Establish an alarm-free condition of the venous pressure transducer
and have the optical detector sense opaque.
– Use the rotary selector to select Start treatment? [OK] to confirm!
and press [OK].

Fresenius Medical Care multiFiltrate TM 6/03.07 5-31


Chapter 5: Adjustment Instructions and Tests

5.5.2 Functional Test of the Drip Counter

The functional tests of the citrate and the calcium drip counter are
performed analogously.

– Remove the drip chamber from the


respective drip counter.
– Move one finger or a pen quickly to and fro
through the optical sensor of the drip
counter.
– Check the result.
– Confirm the drip counter alarm.
– Repeat the test.
– Record the result.

5.5.3 Functional Test of the Hall Sensor

The functional test of the citrate and the calcium pump is successfully
passed if the simulated treatment is completed without any alarm. If
both pumps perform several revolutions without alarm it can be
assumed that both pumps and their Hall sensors are in full working
order.

5.5.4 Functional Test of the Insertion Switch

The functional tests of the insertion switches of the citrate and the
calcium pump are performed analogously.

Remove the tubing segment from the pump


which is to be tested so that the insertion
switch is released.
Check the result:
– the respective pump stops immediately
– an appropriate alarm appears on the
display of the multiFiltrate
Repeat the test
Record the result

5-32 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 5: Adjustment Instructions and Tests

5.5.5 Functional Test of the Line Occlusion

The functional tests of the line occlusion of the citrate and the calcium
pump are performed analogously. The test is performed while the
system is turned off.

Fully insert the test line segment and


manually turn the pump so that one roll
entirely occludes the line segment.
Connect the outlet of the line segment via a
Y-piece to the pressure measuring device
and the syringe.
Apply a pressure of 520 ± 10 mmHg to the
outlet and close the clamp.
Pressure loss within 1 min: max. 10 mmHg
Relieve the pressure and turn the rotor so that
the next roll of the rotor fully occludes the line
segment (approx. 1/3 revolution) and repeat
the steps 3 and 4.
Relieve the pressure and turn the rotor so that
the last roll of the rotor fully occludes the line
segment (approx. 1/3 revolution) and repeat
the steps 3 and 4.
Relieve the pressure and record the result.

Fresenius Medical Care multiFiltrate TM 6/03.07 5-33


Chapter 5: Adjustment Instructions and Tests

5-34 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 6: PC Service Software MFT

6 PC Service Software MFT

6.1 Organization of the Quick Guide

Editorial information The Quick Guide is available as a separate document. It is subject to an


own updating cycle and is revised independently from the Technical
Manual. It may be enclosed to chapter 6.

6.2 General Information

Caution
After each transmission of data from the service program to the dialysis
system, the operator of the service program must check the data at the
dialysis system for plausibility. The operator himself or herself is
responsible for the correctness of the data.

Caution
After each transmission of data from the service program to the dialysis
system, the dialysis system must be switched off and on again before a
patient treatment is started.

Caution
This service program is only intended for service purposes. Ensure that
the interface cable to the PC is not connected during patient treatment.

6.3 Preparation

6.3.1 System Requirements

– PC with at least 10 MByte of free hard disk space


– Microsoft Windows 98, ME, 2000 or XP
– 32 MByte RAM
– 1 CD-ROM drive
– 1 free USB port (for SmartCardReader)
– 1 free RS232 interface (for communication with the Multifiltrate)

Fresenius Medical Care multiFiltrate TM 6/03.07 6-1


Chapter 6: PC Service Software MFT

6.3.2 Software Installation

Caution Install the SmartCardReader drivers before connecting the


SmartCardReader to the PC!
These will be installed when the PC Service Software Multifiltrate is
installed.

Caution
When installing the software an older PC Service Software 4008
version already installed will automatically be uninstalled.
To retain an existing version of the service software, start the installation
with "setup.exe /noremove". In this case, select an installation path
differing from the path of the previous installation to avoid overwriting.

Caution
For Windows NT, 2000, or XP, you must have administrator’s rights to
install the PC Service Software MFT.

Procedure – Start Windows on the computer.


– Insert the installation CD into the CD-ROM drive.
If the setup does not start automatically:
– start the Windows Explorer.
– start Setup.exe from the CD-ROM drive.

– In the Setup dialog Installation Code screen, enter the installation


code printed on the CD cover.

6-2 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 6: PC Service Software MFT

When installing the SmartCard Reader driver under Windows XP a


message may be displayed informing you that the drivers failed to pass
the Windows Logo test.
– The software will be installed after clicking the "Continue Anyway"
button and then the "Finish" button.
The software installation is complete.

6.3.3 Hardware Installation

Connect the PC and the Multifiltrate via the supplied interface cable.

Caution
This is not a standard cable. It is therefore imperative to use the
enclosed interface cable.

Caution
Install the SmartCardReader drivers before connecting the
SmartCardReader to the PC!
These will be installed when the PC Service Software Multifiltrate is
installed.

Connect the SmartCard Reader to a vacant USB port.

6.3.4 ServiceCard Description

The use of the PC Service Software Multifiltrate requires an appropriate


authorization. The PC Service Software Multifiltrate and the respective
ServiceCard will check your authorization.
The ServiceCard is read out via the SmartCard Reader.
– Connect the SmartCard Reader to a vacant USB port.
– Insert the ServiceCard into the SmartCard Reader.
The ServiceCard will be checked when starting the application and
while working with the software. If the card is not inserted or if it is
removed, an error message will be displayed.
Since the authorization is limited to a specific period of time, the
expiration date of the ServiceCard is checked by an operating time
monitoring function. Once this date is exceeded, the PC Service
Software Multifiltrate can no longer be accessed. In this case, the
expiration date must be adapted by an authorized body.

6.3.5 Starting the Software

The software can be started by selecting Start->All Programs-


>Fresenius->Service MFT->Service MFT.

Fresenius Medical Care multiFiltrate TM 6/03.07 6-3


Chapter 6: PC Service Software MFT

6-4 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 7: Block Diagrams and Component Layouts

7 Block Diagrams and Component


Layouts

Fresenius Medical Care multiFiltrate TM 6/03.07 7-1


Chapter 7: Block Diagrams and Component Layouts

7.1 Block Diagram

1 2 3 4

+24V
+12V
+5V
Ethernet (4-Wire) mDL
U+
4kV isoliert
U+ LP244
RJ45 Ethernet (4-Wire) RxD LP123
H DGND +5V H
PGND TxD +24V TS BPTS +12V
+5V RS BPRS +24V
RS232-ISO (PC)Teil der LP124 (Motherboard)
TxD CLK BPCLK
LP244
3 RxD-PC RxD STOP BPSTOP
TxD RxDC-1 RxDD-2 DGND
2 TxD-PC PGND
Blut-Pumpe
RxD TxDC-1 TxDD-2 LP123
5 GND-PC
+24V +24V TS DFTS
+5V +5V RS DFRS
Display-Rechner
+12V TxD CLK DFCLK
TxD RxD-DR RxD STOP DFSTOP
RxD TxD-DR DGND
PGND
Dialysat-Pumpe
+5V
+12V LP123
DGND
+24V TS SUBTS
G CTS +5V RS SUBRS G
DSR RxD-Pump TxD CLK SUBCLK
CD TxD-Pump RxD STOP SUBSTOP
DGND
PGND
SUB-Pumpe
Backlight-Converter Schutz-Rechner
LP123
+12V
DGND Betriebs-Rechner +24V TS FTS
Dis-Dim +5V RS FRS
Dis-Off TxD CLK FCLK
RxD STOP FSTOP
DGND
Drehencoder LP129 (Teil) PGND
Filtrat-Pumpe
1 DGND
2 LP122
3 SW CD
4 Out-B DSR +24V +5VRef-SR +5VRef-SR
5 Out-A CTS +5V
F 6 +5V +5VRef-BR +5VRef-BR S-Temp2 S-Temp2 F
Dis-Off S-Temp1 S-Temp1 S-Temp4 S-Temp4
Dis-Dim S-Temp3 S-Temp3 S-RelSens S-RelSens
I/O LED-Dim LED-Dim SCK-BR SCK-BR S-Rel S-Rel
I/O
DGND Dis-Dim Dis-Dim MOSI-BR MOSI-BR
PCS3-BR PCS3-BR
S-PWM S-PWM
Start
Start/Reset SUB-Plasma
DGND S-HT S-HT
Heizung
S-HT-120 S-HT-120
+5V
Stop +12V
Stop
DGND -12V D-Temp1 D-Temp1 D-Temp2 D-Temp2
DGND D-Temp3 D-Temp3 D-Temp4 D-Temp4
D-PWM D-PWM D-RelSens D-RelSens
IO
Ton-Aus I/O IO D-Rel D-Rel
Ton-Aus Start
DGND Start Start D-HT D-HT
Stop
Stop Stop D-HT-120 D-HT-120 LP129 (Teil)
Ton-Aus
Ton-Aus Ton-Aus
ESC
ESC ESC ESC OK ESC DGND Dialysat-Heizung
E DGND OK OK AGND LED-A Alarm E
PGND

ODSTAT ODSTAT
LP343-1
Druck arteriell LP450
+12V
Part Part +24V Luftdetektor LED- W Warnung
T-Part T-Part +12V Pegel Heben /
AGND LDA1/LDA2 LDA1 Senken
LDSA LDSA Hell-Dunkel
LP343-1 LDACLR LDACLR Druck venös
ODSA ODSA
Filtrat-Druck
+12V Pven Pven VKLZU VKLZU LED-IO IO
PFil PFil T-Pven T-Pven LDA2 LDA1/LDA2
T-PFil T-PFil LDA1 LDA1
AGND LVUPSW LVUPSW OD OD
LVDWNSW LVDWNSW VLVUP LVUP
AGND VLVDWN LVDWN
LP343-1
Druck PGND
D +12V D
Prä-Hämofilter
PPHF PPHF NOTHALT NOTHALT
T-PPHF T-PPHF LP125
AGND
+12V MISO-SR MISO-SR
MOSI-SR MOSI-SR
LP127 SCK-SR SCK-SR
1 +5VRef +12V TA1 TA1 PCS3-SR PCS3-SR
2 DMS+ -12V LED-gn LED-gn +5V
3 DMS- +5V LED-rd LED-rd
4 AGND F-Scl f-Scl1
IO
F-Syn F-SYN IO
Blutleck- Start
F-Tk f-SclTk1 AGND Start PersonalRuf
Waage-1 Detektor Stop
AGND Stop
Ton-Aus Teil der LP124
DGND Teil der LP128 Ton-Aus
ESC
ESC
LP127 Akku Lade- OK
+24V OK
und Test-
1 +5VRef +12V AkkuSens AkkuSens
Schaltung
2 DMS+ -12V Akku-Test Akku-Test
C 3 DMS- +5V Akku-Rel Akku-Rel Akku-In C
4 AGND F-Scl f-Scl2 DGND
F-Syn F-SYN PB-Akku 18V
F-Tk f-SclTk2
AGND Sense+24V
DGND Sense+12V
Sense+5V
Waage-2
+5VRef-BR Sense+5VREF-BR
1 Sense+5VREF-SR +5VRef-SR
1K
2 SD-Ball RxD-BR TxD-SR
1K
Prüfgewichte Hubmagnete
TxD-BR RxD-SR
1
Teil der LP124
2 F-Ball +5V +5VRef-SR
NOTHALT
LP127 Sense-Overvoltage
1 +5VRef +12V Heparinpumpe
B Teil der LP124 (Motherboard) B
2 DMS+ -12V
3 DMS- +5V Ton-BR Ton-BR Ton-SR Ton-SR HP-DOOR Key-up
4 AGND F-Scl f-Scl3
F-Syn F-SYN Vol-Control Vol-Control Test-Alarm Test-Alarm HP-CLK Key-down
F-Tk f-SclTk3
Waage-3
AGND
DGND Sense -12V Mikrofon SPEAKER 8Ohm/1W
LP127
1 +5VRef +12V PGND PGND
2 DMS+ -12V AGND AGND +5V
3 DMS- +5V DGND DGND +24V
4 AGND F-Scl f-Scl4
F-Syn F-SYN -12V DGND
F-Tk f-SclTk4 PGND
AGND
DGND TxDB-2 RxD
RxDB-2 TxD
Waage-4
A A
-12V Tit el Revision
PGND
multiFiltrate
Blockschaltbild I/O C
AGND
Datum 16-Apr-2004
DGND
Datei C:\PRJ\MFT\HW\BLOCK-IO\RE VI SI~1\BLK_IO_3.SCH Blatt 1 von 1
1 2 3 4

7-2 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 7: Block Diagrams and Component Layouts

7.2 AC Wiring

Fresenius Medical Care multiFiltrate TM 6/03.07 7-3


Chapter 7: Block Diagrams and Component Layouts

7.3 P.C.B. LP 122 Heater Control

7.3.1 Block Diagram

7)879& 7834
'328630
79&
28'79&&%+

(
7-
79& 79&

+2(

7-
(-%0
(-%0

(

7)8(-%0
'328630
(-%0
28'(-%0&%+
7834

7.3.2 Description

Assignment of position numbers

Pos. Description Pos. Description


No. No.

1 SI 1 Substituate heater 10 A 6 To dialysate heater

2 SI 2 Dialysate heater 10 A 7 From dialysate temperature sensors

3 LED D5 control pulse of substituate heater 8 From substituate temperature sensors

4 To motherboard P.C.B. LP 124 9 To substituate heater

5 LED D6 control signal of dialysate heater

7-4 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 7: Block Diagrams and Component Layouts

7.3.3 Component Layout

6
6

5
7
4

Fresenius Medical Care multiFiltrate TM 6/03.07 7-5


Chapter 7: Block Diagrams and Component Layouts

7.4 P.C.B. LP 123 Pump Control

7.4.1 Description

Pump coding

J2 (ADR-H) J3 (ADR-L) Address Pump coding

Closed Closed 0 Blood pump

Closed open 1 Filtrate pump

open Closed 2 Substituate pump

open open 3 Dialysate pump

Assignment of position numbers

Pos. Description Pos. Description


No. No.

1 Not assigned 6 Reed contact rotor

2 Jumper J2 7 LED1 threading position

3 Jumper J3 8 Motor speed

4 To motherboard P.C.B. LP 124 9 +/- Motor

5 Door switch (Hall sensor) 10 LED5 operating voltage

7-6 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 7: Block Diagrams and Component Layouts

7.4.2 Component Layout

2 6

10

Fresenius Medical Care multiFiltrate TM 6/03.07 7-7


Chapter 7: Block Diagrams and Component Layouts

7.5 P.C.B. LP 124 Motherboard

7.5.1 Description

Assignment of position numbers

Pos. Description Pos. Description


No. No.

6 Blood pump 21 Filtrate pressure

7 Filtrate pump 22 PHF pressure

8 Substituate pump 23 Lifting magnets I/II

9 Dialysate pump 24 Lifting magnets III/IV

10 Scale I 29 mDl

11 Scales II 30 mDl

12 Scales III 31 Fan

13 Scales IV 32 n.c.

14 User interface 33 n.c.

15 Air detector 34 CiCa module

16 Display processor

17 Heater P.C.B. LP 122B

18 Blood leak detector

19 Heparin pump SI 1 1 A fuse, CiCa module supply voltage

20 Arterial pressure D 14 CiCa module supply voltage LED

7-8 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 7: Block Diagrams and Component Layouts

7.5.2 Component Layout

6
32
27 33

26
17 7

20

21

19
9
22
D 14

15
23 14

24

SI 1
31 13
18

12

16

11

29

10

28 34
25 30

Fresenius Medical Care multiFiltrate TM 6/03.07 7-9


Chapter 7: Block Diagrams and Component Layouts

7.6 P.C.B. LP 125 Blood Leak Detector

7.6.1 Component Layout

7-10 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 7: Block Diagrams and Component Layouts

7.7 P.C.B. LP 127 Scales Board

7.7.1 Description

The EEPROM used for storage is provided with a synchronous serial interface (SPI interface). By means of the
jumper J1 in position 1-2, the EEPROM can be protected from being overwritten inadvertently.

Jumper Position Function

J1 1-2 EEPROM write protection

2-3 EEPROM write enable

7.7.2 Component Layout

Fresenius Medical Care multiFiltrate TM 6/03.07 7-11


Chapter 7: Block Diagrams and Component Layouts

7.8 P.C.B. LP 128, Power Supply Unit

7.8.1 Block Diagram

: 7-
6IKYPEXSV :

: 7-
6IKYPEXSV : HMK

7-
7- : ERE

: 7-
6IKYPEXSV  : HMK

7-
 : ERE

: 7-
6IKYPEXSV :

&EXX 7-
'LEVKI 9&EXX

7.8.2 Description

Fuse arrangement

Pos. Description Pos. Description


No. No.

1 P Fail 10 LED D19 (SI 1)

2 Battery 11 SI 1 (3.15 A / +24 V)

3 SI 8 (5 A) 12 SI 3 (100 mA / -12 V)

4 LED D22 (SI 6) 13 SI 2 (100 mA / -12 V)

5 LED D21 (SI 5) 14 SI 4 (315 mA / +12 V)

6 LED D17 (SI 4) 15 SI 5 (1.6 A / +12 V)

7 LED D18 (SI 2) 16 SI 16 (1.6 A / +5 V)

8 P.C.B. LP 124 17 SI 7 (10 A)

9 LED D20 (SI 3) 18 32 V DC

7-12 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 7: Block Diagrams and Component Layouts

7.8.3 Component Layout

11
10

12
9
8
13
7
14
6

5 15

4 16

3
17
2
18
1

Fresenius Medical Care multiFiltrate TM 6/03.07 7-13


Chapter 7: Block Diagrams and Component Layouts

7.9 P.C.B. LP 129 User Interface

7.9.1 Component Layout

7-14 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 7: Block Diagrams and Component Layouts

7.10 P.C.B. LP 244 Operating and Safety Processors

7.10.1 Block Diagram

: : 23:6%1 )4631


96IJ
ERE O& O&

™4'
(MKMXEP (MKMXEP
1SXSVSPE
-RTYXW 3YXTYXW
1','>

%REPSK
%REPSK
-RTYXW
3YXTYXW

68' 7IVMEP
-RXIVJEGI

7.10.2 Jumper Description

Note
Jumpers are intended for developing purposes only. Do not make any
changes!

Jumper Position Function

J1 1-2 Listening to U12, Rx channel B (1)

2-3 Listening to U12, Rx channel A (2)

J2 1-2 Listening to U12, Tx channel B (1)

2-3 Listening to U12, Tx channel A (2)


(1)
If the P.C.B. LP 244 acts as operating processor, the communication
with the corresponding safety processor can be listened to, with the
jumpers in this position.
(2)
If the P.C.B. LP 244 acts as operating processor, the communication
with the pump processor can be listened to, with the jumpers in this
position.

Fresenius Medical Care multiFiltrate TM 6/03.07 7-15


Chapter 7: Block Diagrams and Component Layouts

Jumper Position Function

J3-4 open Flash EPROM deactivated

Closed Flash EPROM activated (default)

J5 1 Listening to U12, Tx channel A/B, see J2, V.24 level

2 GND

3 Listening to U12, Rx channel A/B, see J1, V.24 level

J6 1 Listening to display processor, see (2), V.24 level

2 GND

3 Listening to display processor, see (2), V.24 level

J7 1-2 Jumper connected at SP

J8 1-2 Jumper, not used at present

J9-10 open Watchdog NMI deactivated

Closed Watchdog NMI activated

7-16 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 7: Block Diagrams and Component Layouts

7.10.3 Component Layout

Fresenius Medical Care multiFiltrate TM 6/03.07 7-17


Chapter 7: Block Diagrams and Component Layouts

7.11 P.C.B LP 343-4 Pressure Transducer

7.11.1 Component Layout

7-18 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 7: Block Diagrams and Component Layouts

7.12 P.C.B. LP 450-3 multiFiltrate Air Detector Control

7.12.1 Component Layout

Fresenius Medical Care multiFiltrate TM 6/03.07 7-19


Chapter 7: Block Diagrams and Component Layouts

7.13 P.C.B. LP 950, Control Board (Heparin Pump)

7.13.1 Component Layout

7-20 Fresenius Medical Care multiFiltrate TM 6/03.07


Chapter 7: Block Diagrams and Component Layouts

7.14 Ci-Ca Module

7.14.1 Block Diagram

Operating processor
(P.C.B. LP 1102 )

MFT Citrate
24V DC Ci-Ca motherboard drop counter
RS 232 (P.C.B. LP MS 0407)
Citrate
pump
Signal and activation Voltage supply

Calcium
Voltage supply drop counter
Signal processing and
distribution Calcium
pump

Fresenius Medical Care multiFiltrate TM 6/03.07 7-21


Chapter 7: Block Diagrams and Component Layouts

7.14.2 Component Layout (P.C.B. LP MS 0407)

7-22 Fresenius Medical Care multiFiltrate TM 6/03.07

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