2.4Functional Test (T1 Test) and Error Messages....................................................................... 2-4
2.4.1Battery Test, Part 1...................................................................................................................... 2-5
2.4.2Scales Test .................................................................................................................................. 2-5
2.4.3Pump Test ................................................................................................................................... 2-6
7.14.2Component Layout (P.C.B. LP MS 0407) .................................................................................. 7-22
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Page 7
1Important Information
1.1Organization of the Technical Manual
Page identificationPage number 1-3 is to be interpreted as: Chapter 1, page 3.
Editorial informationThe 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-todate.
ChapterCurrent version
16/03.07
26/03.07
36/03.07
46/03.07
56/03.07
66/03.07
76/03.07
Chapter 1: Important Information
ChangesManual changes will be released as new editions and supplements. In
general - subject to change without notice.
Fresenius Medical CaremultiFiltrateTM6/03.071-1
Page 8
Chapter 1: Important Information
1.2How to Use the Technical Manual
PurposeThis 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.
RequirementsKnowledge of the current Operating Instructions for the respective
system.
Background experience in mechanics, electrical and medical
engineering.
SpecificationsFor the specifications of the respective system, refer to the current
Operating Instructions.
Circuit diagrams and
component layouts
Explanation of the Note
and Caution symbols used
The identification on the PCB permits the operator/technician to verify if
the circuit diagram/component layout matches the PCB actually
installed in the system.
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.
1-2Fresenius Medical CaremultiFiltrateTM6/03.07
Page 9
1.3Precautions for Working on the System
Authorized personsAssembly, extensions, adjustments, modifications or repairs may only
be carried out by the manufacturer or persons authorized by him.
Chapter 1: Important Information
Test equipment and
accessories
PrecautionsWhen working on the open system, the following precautions must be
ESD precautionsWhen repairing and when replacing spare parts, observe the applicable
The activities described in the Technical Manual require the availability
of the necessary technical test equipment and accessories.
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 (e.g. EN 100 015-1).
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Page 10
Chapter 1: Important Information
1.4Addresses
ManufacturerFresenius Medical Care AG & Co. KGaA
Please address any inquiries to:
D-61346 Bad Homburg
Germany
+49 (0)6172/609-0
www.fmc-ag.com
Service
Central Europe
International
service
Local service
Fresenius Medical Care
Deutschland GmbH
Geschäftsbereich Zentraleuropa
Kundendienst / Servicecenter
Steinmühlstrasse 24b
61352 Bad Homburg
Germany
Phone: +49 6172 609-7100
Fax: +49 6172 609-7102
E-mail: ServicecenterD@fmc-ag.com
Fresenius Medical Care
Deutschland GmbH
Service Support International
Hafenstrasse 9
D-97424 Schweinfurt
Germany
Phone: +49 9721 678-333 (hotline)
Fax: +49 9721 678-130
1-4Fresenius Medical CaremultiFiltrateTM6/03.07
Page 11
2Functional Description
2.1Extracorporeal 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
Chapter 2: Functional Description
2.1.1Pumps
Altogether, the multiFiltrate is provided with four pumps:
PumpDelivery rate
Blood pump10 500 ml/min
Filtrate pump10 180 ml/min
Substituate pump10 170 ml/min
Dialysate pump10 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.
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Chapter 2: Functional Description
2.1.2Heaters
2.1.3Pressure Transducer
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.
Four pressures are measured at the multiFiltrate:
Arterial pressure,
Measuring transducer (P.C.B. LP 343-1) between the patients
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 patients 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.
2.1.4Air 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.
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.
2.1.6Blood 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.
2.1.7Heparin Pump
Chapter 2: Functional Description
2.2Weighing Units
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 microprocessorcontrolled 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).
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.
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Chapter 2: Functional Description
2.3Ci-Ca Module (Option)
The Ci-Ca module is intended for regional citrate anticoagulation in the
CVVHD treatment therapy.
Turning power onThe 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 testIf 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 testThe 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 errorsIf 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.
2.4Functional 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.
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Page 15
Chapter 2: Functional Description
2.4.1Battery 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.
2.4.2Scales 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 messageCausesAction required
Scale I
Cal. factor missing, error.
Acknowledge with
[START/RESET] key.
Scale I
Temp. coeff. factors missing, error.
Acknowledge with
[START/RESET] key.
Scale I
Movement detected on Scale I.
Acknowledge with
[START/RESET] key.
Lithium battery on P.C.B. LP 244OP discharged.
Defect of the EPROM on P.C.B.
LP 127 of the scales specified.
The system is not in a stable
position. The scales are subjected
to a draft. Bags with tubing system
are placed on the scales; this is
especially applicable to filtrate
scales.
The +12 V and/or 12 V voltage(s)
is (are) missing.
Scales mechanics not smooth.Check for smoothness and adjust,
Replace the battery and execute
the calibration step in the Service
program.
Replace the P.C.B. and the
weighing bar and execute the
calibration step in the Service
program.
Set up the system in a stable
position. Remove the system from
the draft, or close the window.
Relieve the scales.
Check the fuses on the PSU board
LP 128 and replace the P.C.B.
LP 128, if necessary.
Caution: All pressures must be
checked and calibrated, if
necessary.
if necessary. Weight check in the
Service program.
Fit the connector to the
motherboard and/or to the P.C.B.
LP 127. Replace the ribbon cable.
Caution: All scales and pressures
must be calibrated.
Page 16
Chapter 2: Functional Description
Error messageCausesAction required
Scale I
Test weight outside tolerance.
Acknowledge with
[START/RESET] key.
Scale I
Zero offset outside tolerance.
Acknowledge with
[START/RESET] key.
The system is not in a stable
position. The scales are subjected
to a draft. Bags with tubing system
are placed on the scales; this is
especially applicable to filtrate
scales.
Lifting magnet for ball not
connected or defective.
Ball mechanics not smooth.Check for smoothness and adjust,
The system is not in a stable
position. The scales are subjected
to a draft. Bags with tubing system
are placed on the scales; this is
especially applicable to filtrate
scales.
Scales mechanics not smooth.Check for smoothness and adjust,
Test weight fails to drop back. Ball
mechanics not smooth.
Set up the system in a stable
position. Remove the system from
the draft, or close the window.
Relieve the scales.
Fit the connector to the
motherboard. If defective, the lifting
magnet must be replaced.
if necessary. Weight check in the
Service program.
Set up the system in a stable
position. Remove the system from
the draft, or close the window.
Relieve the scales.
if necessary. Weight check in the
Service program.
Check for smoothness and adjust,
if necessary. Weight check in the
Service program (ESC Service).
2.4.3Pump 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.
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Page 17
Chapter 2: Functional Description
Error messageCausesAction required
Blood pump
Blood pump door open.
Acknowledge with
[START/RESET] key.
Blood pump
Not stopped by operating
processor.
Acknowledge with
[START/RESET] key.
Blood pump
Wrong speed, rate.
Acknowledge with
[START/RESET] key.
Blood pump door open.Close the blood pump door.
Magnet in blood pump door
missing.
Hall sensor in pump housing not
connected or defective.
Control electronics (P.C.B. LP 123)
of the specified pump defective.
Caution: All scales and pressures
must be calibrated.
Replace P.C.B. LP 123.
Caution: The BLD must be
calibrated.
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 messageCausesAction required
Arterial pressure
Factors / Offset lost.
Acknowledge with
[START/RESET] key.
Lithium battery on P.C.B. LP 244OP discharged.
Replace the battery and execute
the calibration step in the Service
program.
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Page 19
Chapter 2: Functional Description
Error messageCausesAction required
Arterial pressure
Zero outside tolerance.
Acknowledge with
[START/RESET] key.
Arterial pressure
Detuning outside tolerance
Acknowledge with
[START/RESET] key.
Zero point drifted off.Check the setting and calibrate the
Caution: All scales and pressures
must be calibrated.
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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Page 20
Chapter 2: Functional Description
Error messageCausesAction required
Opt. detector
Senses opaque fluid.
Acknowledge with
[START/RESET] key.
Opt. detector
Fails to sense opaque fluid after
attenuation.
Acknowledge with
[START/RESET] key.
Blood present in the system or
objects inserted in the OD.
OD adjusted improperly.Check the setting of the OD.
P.C.B. LP 450-3 defective.Replace the P.C.B. LP 450-3.
Measuring head of OD defective.Replace and adjust the OD
Caution: When replacing the
P.C.B. LP 450-3, check / adjust the
air detector, optical detector and
venous pressure transducer.
measuring head.
Caution: The BLD must be
calibrated.
Caution: When replacing the
P.C.B. LP 450-3, check / adjust the
air detector, optical detector and
venous pressure transducer.
2.4.6Air Detector
Caution: All scales and pressures
must be calibrated.
AD 28 defective.Replace AD 28-1.
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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Page 21
Chapter 2: Functional Description
Error messageCausesAction required
Air detector
LDA1 not in alarm mode.
Acknowledge with
[START/RESET] key.
Air detector
Clamp does not close.
Acknowledge with
[START/RESET] key.
LD adjusted improperly.Check the setting of the LD.
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.
Ultrasonic detector defective.Replace and adjust the ultrasonic
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 messageCausesAction required
Blood leak detector
Calibration values incorrect
or missing.
Acknowledge with
[START/RESET] key.
Lithium battery on P.C.B. LP 244SP discharged.
Replace the battery and execute
the calibration step in the Service
program.
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Page 22
Chapter 2: Functional Description
Error messageCausesAction required
Blood leak detector
Outside acceptable range.
Remove filtrate line.
Acknowledge with
[START/RESET] key.
Blood leak detector
Alarm-free after signal attenuation.
Acknowledge with
[START/RESET] key.
2.4.8Heater
Empty filtrate line or objects
inserted in the BLD sensor head.
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.
Remove the filtrate line or the
objects.
Replace P.C.B. LP 125 and the
BLD sensor head, and calibrate the
BLD.
Caution: The BLD must be
calibrated.
Replace P.C.B. LP 125 and the
BLD sensor head, and calibrate the
BLD.
Caution: All scales and pressures
must be calibrated.
Error messageCausesAction required
Lower heater
Switch-off path SP defective
(Sub. relay not open)
Voltage missing.
Fuse defective.
Acknowledge with
[START/RESET] key.
2-12Fresenius Medical CaremultiFiltrate TM6/03.07
Safety relay on P.C.B. LP 122
defective.
Activation on P.C.B. LP 244-SR
defective.
Supply voltage for heater not
connected.
Fuse on P.C.B. LP 122 defective.Replace the fuse.
Replace P.C.B. LP 122.
Replace P.C.B. LP 244-SR.
Caution: The BLD must be
calibrated.
Fit the socket on P.C.B. LP 122.
Page 23
Chapter 2: Functional Description
Error messageCausesAction required
Lower heater
Control FET short-circuit
Acknowledge with
[START/RESET] key.
Lower heater
Bag sensor broken.
Acknowledge with
[START/RESET] key.
Lower heater
Foil sensor broken.
Acknowledge with
[START/RESET] key.
Lower heater
Control FET defective.Replace P.C.B. LP 122.
Activation on P.C.B. LP 244-OP
defective.
Socket of sensors not fitted.Fit the socket on P.C.B. LP 122.
Sensor interrupted.Replace the heater.
P.C.B. LP 122 defectiveReplace P.C.B. LP 122.
Converter on P.C.B. LP 244-SR
defective.
Socket of sensors not fitted.Fit the socket on P.C.B. LP 122.
Sensor interrupted.Replace the heater.
P.C.B. LP 122 defectiveReplace P.C.B. LP 122.
Converter on P.C.B. LP 244-SR
defective.
Bag sensor short-circuit.Replace the heater.
Replace P.C.B. LP 244-OP.
Caution: All scales and pressures
must be calibrated.
Replace P.C.B. LP 244-SR.
Caution: The BLD must be
calibrated.
Replace P.C.B. LP 244-SR.
Caution: The BLD must be
calibrated.
Bag sensor short-circuit.
Acknowledge with
[START/RESET] key.
Lower heater
Foil sensor short-circuit.
Acknowledge with
[START/RESET] key.
Lower heater
Sub. relay not closed,
foil defective.
Acknowledge with
[START/RESET] key.
P.C.B. LP 122 defectiveReplace P.C.B. LP 122.
Converter on P.C.B. LP 244-SR
defective.
Bag sensor short-circuit.Replace the heater.
P.C.B. LP 122 defectiveReplace P.C.B. LP 122.
Converter on P.C.B. LP 244-SR
defective.
Supply voltage for heater not
connected.
Fuse on P.C.B. LP 122 defective.Replace the fuse.
Heater foil not connected.Connect the heater foil to P.C.B.
Heater foil interrupted.Replace the heater.
Safety relay defective.Replace P.C.B. LP 122.
Activation on P.C.B. LP 244-SR
defective.
Replace P.C.B. LP 244-SR.
Caution: The BLD must be
calibrated.
Replace P.C.B. LP 244-SR.
Caution: The BLD must be
calibrated.
Fit the socket on P.C.B. LP 122.
LP 122.
Replace P.C.B. LP 244-SR.
Caution: The BLD must be
calibrated.
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Page 24
Chapter 2: Functional Description
Error messageCausesAction required
Lower heater
Bag sensors,
OP-SP not synchronous
Acknowledge with
[START/RESET] key.
Lower heater
Foil sensors,
OP-SP not synchronous
Acknowledge with
[START/RESET] key.
Heater still warm after last
treatment or Service program.
Sensor board (P.C.B. LP 1220)
defective.
P.C.B. LP 122 defectiveReplace P.C.B. LP 122.
Converter on P.C.B. LP 244-SR
defective.
Converter on P.C.B. LP 244-OP
defective.
Heater still warm after last
treatment or Service program.
Sensor board (P.C.B. LP 1220)
defective.
P.C.B. LP 122 defectiveReplace P.C.B. LP 122.
Converter on P.C.B. LP 244-SR
defective.
Allow the heater to cool down.
Replace the heater.
Replace P.C.B. LP 244-SR.
Caution: The BLD must be
calibrated.
Replace P.C.B. LP 244-OP.
Caution: All scales and pressures
must be calibrated.
Allow the heater to cool down.
Replace the heater.
Replace P.C.B. LP 244-SR.
Caution: The BLD must be
calibrated.
Lower heater
Foil sensor detuning,
no overtemperature cutoff.
Acknowledge with
[START/RESET] key.
Lower heater
Bag sensor detuning,
no overtemperature.
Acknowledge with
[START/RESET] key.
Converter on P.C.B. LP 244-OP
defective.
DIL relay on P.C.B. LP 122
defective.
DIL relay on P.C.B. LP 122
defective.
Activation on P.C.B. LP 244-OP
defective.
Replace P.C.B. LP 244-OP.
Caution: All scales and pressures
must be calibrated.
Replace P.C.B. LP 122.
Replace P.C.B. LP 122.
Replace P.C.B. LP 244-OP.
Caution: All scales and pressures
must be calibrated.
2-14Fresenius Medical CaremultiFiltrate TM6/03.07
Page 25
Chapter 2: Functional Description
Error messageCausesAction required
Lower heater
Foil sensor detuning,
no overtemperature.
Acknowledge with
[START/RESET] key.
Lower heater
FET control defective
Acknowledge with
[START/RESET] key.
DIL relay on P.C.B. LP 122
defective.
Activation on P.C.B. LP 244-OP
defective.
FET on P.C.B. LP 122 defective.Replace P.C.B. LP 122.
Activation on P.C.B. LP 44-OP
defective.
Replace P.C.B. LP 122.
Replace P.C.B. LP 244-OP.
Caution: All scales and pressures
must be calibrated.
Replace P.C.B. LP 244-OP.
Caution: All scales and pressures
must be calibrated.
2.4.9Battery 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 messageCausesAction required
Battery test
Battery not connected, defective.
Acknowledge with
[START/RESET] key.
Battery not connected.Connect the rechargeable battery.
Battery terminal voltage without
load <<18 V.
Converter on P.C.B. LP 244-OP
defective.
Replace the battery.
Replace P.C.B. LP 244-OP.
Caution: All scales and pressures
must be calibrated.
Battery test
Load test failed.
Acknowledge with
[START/RESET] key.
Fresenius Medical CaremultiFiltrate TM6/03.072-15
Resistor or load relay on the PSU,
P.C.B. LP 128, defective.
Converter or activation on P.C.B.
LP 244-OP defective.
Replace P.C.B. LP 128.
Caution: All pressures must be
checked and calibrated, if
necessary.
Replace P.C.B. LP 244-OP.
Caution: All scales and pressures
must be calibrated.
Page 26
Chapter 2: Functional Description
Error messageCausesAction required
Battery test
Insufficient capacity.
Acknowledge with
[START/RESET] key.
System not used for a prolonged
period or frequent power failure
(preparation).
Battery defective.
Charging circuit on the PSU board,
P.C.B. LP 128, defective.
Converter on P.C.B. LP 244-OP
defective.
Load the battery from the mains for
a minimum of 10 hours.
Replace the battery.
Replace P.C.B. LP 128.
Caution: All pressures must be
checked and calibrated, if
necessary.
Replace P.C.B. LP 244-OP.
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 messageCausesAction required
Audible alarm
Not silenced.
Acknowledge with
[START/RESET] key.
Constant ambient noise.Repeat the test after the noise has
stopped.
Loud humming noise on the
loudspeaker.
Check the route of the loudspeaker
cable. Replace the loudspeakermicrophone 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
Not active.
Acknowledge with
[START/RESET] key.
2-16Fresenius Medical CaremultiFiltrate TM6/03.07
Alarm tone not audible.Loudspeaker cable connected to
P.C.B. LP 124?
Replace the loudspeakermicrophone unit or the
motherboard P.C.B. LP 124.
Error message despite audible
alarm.
Microphone cable connected to
P.C.B. LP 124?
Replace the loudspeakermicrophone unit or the
motherboard P.C.B. LP 124.
Page 27
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 messageCausesAction required
Heparin pump
Heparin pump not ready.
No communication.
Heparin pump
Heparin pump optionally
deactivated in Service mode
Heparin pump
Heparin pump detects internal error
Heparin pump
Wrong / unauthorized syringe type
detected
Heparin pump
Unknown hardware error
Heparin pump does not respond.Acknowledge with
[START/RESET] key.
Heparin pump deactivated.
Heparin pump manually
deactivated in the Service mode
Internal heparin pump error without
definite cause.
Wrong syringe type set.Acknowledge with
Heparin pump detects an unknown
hardware error.
Acknowledge with
[START/RESET] key.
Heparin pump deactivated.
Acknowledge with
[START/RESET] key.
Heparin pump deactivated.
[START/RESET] key.
Heparin pump deactivated.
Select a valid syringe type.
0 = 50 ml P syringe
1 = 30 ml heparin syringe
2 = 50 ml Injectomat syringe
Acknowledge with
[START/RESET] key.
Heparin pump deactivated.
Heparin pump
Heparin pump hardware error
Gate array error
Heparin pump
Spike on reset line
Heparin pump
Wrong HEX switch position
Heparin pump
Powerdown
Fresenius Medical CaremultiFiltrate TM6/03.072-17
Heparin pump detects an error in
the gate array.
A reset occurred during operation.Acknowledge with
Wrong HEX switch position set.Acknowledge with
Powerdown without 24 V-cutoff.Acknowledge with
Acknowledge with
[START/RESET] key.
Heparin pump deactivated.
[START/RESET] key.
Heparin pump deactivated.
[START/RESET] key.
Heparin pump deactivated.
Set a valid HEX switch position.
[START/RESET] key.
Heparin pump deactivated.
Page 28
Chapter 2: Functional Description
Error messageCausesAction required
Heparin pump
Operating processor internal
communication error with heparin
pump
Heparin pump
Watchdog error
Heparin pump
NOVRAM error
Heparin pump
CAMUS transmission error
2.4.12 multiDataLink
Erroneous data transmission.
Wrong or missing characters.
Check sum error.
The watchdog is not able to
interrupt the 24 V control voltage
for the stepper motor.
The CRC protection of the data
saved in the E2PROM is not
correct.
Not used in the multiFiltrate.Not used in the multiFiltrate.
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.
Acknowledge with
[START/RESET] key.
Heparin pump deactivated.
Acknowledge with
[START/RESET] key.
Heparin pump deactivated.
Acknowledge with
[START/RESET] key.
Heparin pump deactivated.
Error messageCausesAction required
multiDataLink
multiDataLink not standby
No communication
multiDataLink
multiDataLink optionally
deactivated in Service mode
multiDataLink does not respond.Acknowledge with
[START/RESET] key.
multiDataLink deactivated.
multiDataLink manually
deactivated in the Service program.
Acknowledge with
[START/RESET] key.
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:
2-18Fresenius Medical CaremultiFiltrate TM6/03.07
Page 29
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
number
281Lacking Ci Hall impulse after test was started
282Ci Hall impulse too early during pump stop test
283Ci Hall impulse too late during pump stop test
285Ci Hall impulse too early during pump stop test
286Ci Hall impulse too late during pump stop test
288Ci Hall impulse too early during insertion switch
289Ci Hall impulse too late during insertion switch
291Lacking Ca Hall impulse after test was started
292Ca Hall impulse too early during pump stop test
DescriptionPossible cause
(>5 s).
(<7 s).
(>9 s).
(<7 s).
(>9 s).
test (<7 s).
test (>9 s).
(>5 s).
(<7 s).
The rotor of the citrate pump is loose, jammed or
blocked.
Insertion switch pressed --> citrate line already
inserted.
The rotor of the citrate pump is loose, jammed or
blocked.
Insertion switch pressed --> citrate line already
inserted during the test.
The rotor of the citrate pump is loose, jammed or
blocked.
Insertion switch pressed --> citrate line already
inserted during the test.
The rotor of the citrate pump is loose, jammed or
blocked.
The rotor of the Ca pump is loose, jammed or
blocked.
Insertion switch pressed --> calcium line already
inserted.
293Ca Hall impulse too late during pump stop test
(>9 s).
295Ca Hall impulse too early during pump stop test
(<7 s).
296Ca Hall impulse too late during pump stop test
(>9 s).
298Ca Hall impulse too early during insertion switch
test (<7 s).
299Ca Hall impulse too late during insertion switch
test (>9 s).
Fresenius Medical CaremultiFiltrate TM6/03.072-19
The rotor of the Ca pump is loose, jammed or
blocked.
Insertion switch pressed --> calcium line already
inserted during the test.
The rotor of the Ca pump is loose, jammed or
blocked.
Insertion switch pressed --> calcium line already
inserted during the test.
The rotor of the Ca pump is loose, jammed or
blocked.
Page 30
Chapter 2: Functional Description
2.5Error Messages
2.5.1Alarm Messages
These messages cause all pumps to stop
CodeDescription
E10Blood pump: Blood pump door open
E11Blood pump: Stop
E12Blood pump: Wrong speed, rate
E13Arterial pressure, arterial pressure too low
E14Arterial pressure, arterial pressure too high
E15Venous pressure, venous pressure too low
E16Venous pressure, venous pressure too high
E17TMP, TMP too low
E18TMP, TMP too high
E19System stopped, Stop key has been pressed
E20Pre-filter pressure/ Pre-filter pressure too low (for
hemoperfusion)
E21Pre-filter pressure, pre-filter pressure too low
E22Pre-filter pressure, pre-filter pressure too high
not open), voltage not present, SI defective (for P.C.B.
LP122-B)
W261Lower heater: Control FET short circuit (for P.C.B.
LP122-B)
W262Upper heater: Control FET short circuit (for P.C.B.
LP122-B)
W263Air detector: Transmitting voltage for air detector not
present / nonconforming (for AD28)
W264Ci-Ca module: Ci-Ca module does not respond, select
alternate anticoagulation if necessary!
W265Ci-Ca module: Switch-off path "sleep" does not react,
select alternate anticoagulation if necessary!
W266Balancing: HF bag change aborted
W281Ci-Ca module: Citrate pump - test F1, Rotor slack or
stuck?
W282Ci-Ca module: Citrate pump - OP test F2, rotor slack?
W283Ci-Ca module: Citrate pump - OP test F3, rotor slack or
stuck?
W285Ci-Ca module: Citrate pump - WD test F5, rotor slack?
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Chapter 2: Functional Description
CodeDescription
W286Ci-Ca module: Citrate pump - WD test F6, rotor slack or
stuck?
W288Ci-Ca module: Citrate pump - insertion switch test F8,
line pump segment inserted too early or rotor slack?
W289Ci-Ca module: Citrate pump - insertion switch test F9,
rotor slack or stuck?
W291Ci-Ca module: Calcium pump test F11, rotor slack or
stuck?
W292Ci-Ca module: Calcium pump - OP test F12, rotor
slack?
W293Ci-Ca module: Calcium pump - OP test F13, rotor slack
or stuck?
W295Ci-Ca module: Calcium pump - WD test F15, rotor
slack?
W296Ci-Ca module: Calcium pump - WD test F16, rotor slack
or stuck?
2.5.3Fatal Errors
W298Ci-Ca module: Calcium pump - insertion switch test
F18, line pump segment inserted too early or rotor
slack?
W299Ci-Ca module: Calcium pump - insertion switch test
F19, rotor slack or stuck?
W330Ci-Ca module: Balance switched off!, Ca supply
interrupted!
W331Ci-Ca module: Filtrate rate too low for set Ca dose!,
Increase dialysate or substituate or Ca dose if
necessary!
W332Ci-Ca module: Filtrate rate too high for set Ca dose!,
Reduce dialysate or substituate or Ca dose if
necessary!
W333Ci-Ca module: Blood flow too low for set citrate dose!,
Increase blood flow or citrate dose if necessary!
W334Ci-Ca module: Blood flow too high for set citrate dose!,
Reduce blood flow or citrate dose if necessary!
These messages cause the treatment to stop.
2-30Fresenius Medical CaremultiFiltrate TM6/03.07
Page 41
Chapter 2: Functional Description
CodeDescription
E500Scale 1: (factors missing during treatment)
E501Scale 2: (factors missing during treatment)
E502Scale 3: (factors missing during treatment)
E503Scale 4: (factors missing during treatment)
E504Memory error: (double values incorrect)
E505Blood pump: (does not respond)
E506Substituate pump: (does not respond)
E507Dialysate pump: (does not respond)
E508Filtrate pump: (does not respond)
E509Overvoltage +5V
E510Overvoltage +12V
E511Processor test OP: CPU defective,
E512Processor test OP: Incorrect CRC interrupt vectors
E513Processor test OP: CRC CRC area defective
E514Processor test OP: CRC Code area defective
E515Processor test OP: RAM, bank B defective
E516Processor test OP: RAM, bank 8 defective
E517State transition
E518Program sequence
E519Self-Test
E520Balancing
E521SP does not respond
E522DP does not respond
E523Program flow OP: Watchdog
E524Processor test OP: Watchdog does not respond
E525Processor test SP: CPU
E526Processor test SP: Program memory vectors
E527Processor test SP: Program memory - CRC area
E528Processor test SP: Program memory - code area
E529Processor test SP: RAM - bank B
E530Processor test SP: RAM - bank B
E531Processor test SP: Watchdog does not respond
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Chapter 2: Functional Description
CodeDescription
E532Invalid software combination: OP, DP, SP
E533Ci-Ca module: Logoff of the option by the MFT
E534Ci-Ca module: Alarm of the option not followed by MFT
alarm
E535Ci-Ca module: Timeout of the status message of the
MFT (>2.5 s)
E536Ci-Ca module: Too many status messages of the MFT
(2x<0.5 s)
E537Ci-Ca module: Receipt of message not confirmed
E538Ci-Ca module: unknown identifier
E539Ci-Ca module: Write buffer full
E540Ci-Ca module: Read buffer full
E541Ci-Ca module: Unable to write on TXe
E542Ci-Ca module: Missing setup values from the MFT (at
end of line installation)
E550Ci-Ca module: Too many extra Hall pulses from the Ca
pump
E551Ci-Ca module: Ca pump could not be stopped
E560Ci-Ca module: Too many extra Hall pulses from the
citrate pump
E561Ci-Ca module: Citrate pump could not be stopped
E570Ci-Ca module: Error on checking variable replication
(Int)
E571Ci-Ca module: Error on checking variable replication
(Float)
E572Ci-Ca module: Error on checking variable replication
(Long)
E573Ci-Ca module: Error on checking software diversity
2-32Fresenius Medical CaremultiFiltrate TM6/03.07
Page 43
2.5.4Error Codes of Scales Lo-Level Routines
Scale no. 1
Code Description
E30001Standstill not possible (timeout after 10 sec)
E30002Weight value out of range (overload or underload)
E30003Incorrect calibration weight value
E30004Negative initial weight
E30005Wrong initial weight
E30006ACT_WGT 65535
E30007Alarm limits permanently violated
E30008INF_WGT invalid
E30050Calibration factor missing or incorrect
Chapter 2: Functional Description
Scale no. 2
E30051Temp. coeff. factors missing or incorrect
E30052Double fuse defective (zero value)
E30053Temperature sensor missing / defective
CodeDescription
E30101Standstill not possible (timeout after 10 sec)
E30102Weight value out of range (overload or underload)
E30103Incorrect calibration weight value
E30104Negative initial weight
E30105Wrong initial weight
E30106ACT_WGT 65535
E30107Alarm limits permanently violated
E30108INF_WGT invalid
E30150Calibration factor missing or incorrect
E30151Temp. coeff. factors missing or incorrect
E30152Double fuse defective (zero value)
E30153Temperature sensor missing / defective
Fresenius Medical CaremultiFiltrate TM6/03.072-33
Page 44
Chapter 2: Functional Description
Scale no. 3
Code Description
E30201Standstill not possible (timeout after 10 sec)
E30202Weight value out of range (overload or underload)
E30203Incorrect calibration weight value
E30204Negative initial weight
E30205Wrong initial weight
E30206ACT_WGT 65535
E30207Alarm limits permanently violated
E30208INF_WGT invalid
E30250Calibration factor missing or incorrect
E30251Temp. coeff. factors missing or incorrect
E30252Double fuse defective (zero value)
Scale no. 4
E30253Temperature sensor missing / defective
CodeDescription
E30301Standstill not possible (timeout after 10 sec)
E30302Weight value out of range (overload or underload)
E30303Incorrect calibration weight value
E30304Negative initial weight
E30305Wrong initial weight
E30306ACT_WGT 65535
E30307Alarm limits permanently violated
E30308INF_WGT invalid
E30350Calibration factor missing or incorrect
E30351Temp. coeff. factors missing or incorrect
E30352Double fuse defective (zero value)
E30353Temperature sensor missing / defective
2-34Fresenius Medical CaremultiFiltrate TM6/03.07
Page 45
Scales nos. 3 and 4 (both)
Chapter 2: Functional Description
CodeDescription
E30401Standstill not possible (timeout after 10 sec)
E30402Weight value out of range (overload or underload)
E30403Incorrect calibration weight value
E30404Negative initial weight
E30405Wrong initial weight
E30406ACT_WGT 65535
E30407Alarm limits permanently violated
E30408INF_WGT invalid
E30450Calibration factor missing or incorrect
E30451Temp. coeff. factors missing or incorrect
E30452Double fuse defective (zero value)
E30453Temperature sensor missing / defective
2.5.5Error Codes of Pressures Lo-Level Routines
PART
Code Description
E30551Calibration factor missing, incorrect
E30552Offset factor missing, incorrect
E30553Offset > measurement value
E30557DAC setting missing, incorrect
PPHF
Code Description
E30651Calibration factor missing, incorrect
E30652Offset factor missing, incorrect
E30653Offset > measurement value
E30657DAC setting missing, incorrect
Fresenius Medical CaremultiFiltrate TM6/03.072-35
Page 46
Chapter 2: Functional Description
PVEN
PFIL
Code Description
E30751Calibration factor missing, incorrect
E30752Offset factor missing, incorrect
E30753Offset > measurement value
E30757DAC setting missing, incorrect
CodeDescription
E30851Calibration factor missing, incorrect
E30852Offset factor missing, incorrect
E30853Offset > measurement value
E30857DAC setting missing, incorrect
2.5.6Error Codes of Heparin Pump Lo-Level Routines
Code Description
E31000BCC error
E31001Handshake error to HP
E31002Overflow sensitivity: buffer
E31003Invalid control character
E31004No end character received
E31005HP string 3 answered with NAK
E31006Wrong unknown command from HP
E31008HP not ready
E31009HP by option deactivated in Service mode
E31010HP detects internal error
E31011Wrong / unauthorized syringe type detected
E31012HP failed to stop
E31013Syringe empty
E31014HP hardware error #1, GA error
2-36Fresenius Medical CaremultiFiltrate TM6/03.07
Page 47
CodeDescription
E31015ditto #4, spike on reset line
E31016ditto #5, wrong HEX switch position
E31017ditto #8, power down
E31018ditto #11, slotted disk error
E31019ditto #55, slotted disk not found
E31020Unknown hardware error
E31021Internal HP communication error (group error)
2.5.7Error Codes of Pumps Lo-Level Routines
Code Hex Description
E642560xFB00Invalid tubing type
Chapter 2: Functional Description
E647670xFCFFNo response from blood pump
E650230xFDFFditto Filtrate pump
E652790xFEFFditto Substituate pump
E655350xFFFFditto Dialysate pump
2.6Overview of Display Identification Numbers
Fresenius Medical CaremultiFiltrate TM6/03.072-37
Page 48
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.
confirmation buttons "Refill citrate", "Refill calcium" and
"Ci-Ca lines primed and free from air? "OK" to confirm!"
M95Preparation, Deselect Ci-Ca anticoagulation with
confirmation button "No" and "Yes"
M96Preparation, Deselection Ci-Ca, with note H105 with
confirmation button "All conditions fulfilled? "OK" to
confirm!"
M97Treatment, Ci-Ca bag change menu, concentrations
and bag volumes displayed, after Z3 protocol 5
confirmation buttons for the Ci-Ca bag exchange
appear.
M98Preparation, Deselection Ci-Ca, with note H107 with
confirmation button "All conditions fulfilled? "OK" to
confirm!"
Fresenius Medical CaremultiFiltrate TM6/03.072-41
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Chapter 2: Functional Description
2-42Fresenius Medical CaremultiFiltrate TM6/03.07
Page 53
3Installation
3.1Preface
Chapter 3: Installation
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
Central Europe
International
service
Fresenius Medical Care
Deutschland GmbH
Geschäftsbereich Zentraleuropa
Kundendienst / Servicecenter
Steinmühlstraße 24
61352 Bad Homburg
Germany
Phone: +49 6172 609-7100
Fax: +49 6172 609-7102
E-mail: ServicecenterD@fmc-ag.com
For initial start-up onlyThis 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 qualificationThe 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
accessories
Environmental conditionsVariations in temperature during transport may lead to condensation
TSC/TMC/MA intervalsThe TSC/TMC/MA procedures for this system are to be performed after
The activities described in this technical document require the
availability of the necessary technical test equipment and accessories.
Any information on the specifications must be observed.
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.
12 months.
3-2Fresenius Medical CaremultiFiltrateTM6/03.07
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Chapter 3: Installation
3.3Initial 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
1.1Unpack the system.
1.2Check that all parts of the system have been accounted for.
1.3System without visible shipping damage.
2Preparing for operation
2.1Place the scales trays on the scales plates.
2.2Install the IV pole.
2.3Connect the power cable and secure it to prevent improper replacement.
3Visual inspections
3.1Fuses accessible from the outside comply with the indicated values.
3.2Labels and labeling are present and legible.
3.3The mechanical condition permits further safe use.
3.4There are no signs of damage or dirt.
3.5The power cable shows no signs of damage.
4Functional check
4.1Pump checked for stopping with open door.
Blood pump
Filtrate pump
Substituate pump
Dialysate pump
4.2The venous occlusion clamp closes after an air detector alarm.
Fresenius Medical CaremultiFiltrateTM6/03.073-3
Page 56
Chapter 3: Installation
No. Description Meas.
value
4.3The pressure of 2 bar applied in the venous bubble catcher may not drop by more
than 0.1 bar within 3 minutes.
4.4Air 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.
Calibration: Test load on scales: display 5000 g ±1 g
Scales II
Calibration: Test load on scales: display 5000 g ±1 g
Scales III
Calibration: Test load on scales: display 5000 g ±1 g
Scales IV
Calibration: Test load on scales: display 5000 g ±1 g
________
________
________
_______g
_______g
_______g
_______g
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Chapter 3: Installation
No. Description Meas.
value
5 Ci-Ca module option: visual inspections
5.1Colored markings of drop counters must be present.
5.2Adhesive labels of citrate and calcium pumps are present and legible.
5.3The mechanical condition permits further safe use.
5.4There are no signs of damage or dirt.
5.5Line holders must be present and undamaged.
6Ci-Ca module option: extracorporeal components
6.1Citrate drop counter checked for proper function
6.2Calcium drop counter checked for proper function
6.3Line occlusion of the pumps checked.
Citrate pump (pressure loss max. 10 mmHg/min)
Calcium pump (pressure loss max. 10 mmHg/min)
________
________
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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!
7.1Visual inspections performed as specified under 3 and 5.
7.2Protective earth resistance max. 0.3 (with power cable)______
7.3Leakage 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
(maximum 500 A, see Additional conditions)
Device leakage current mains polarity 2: _______ A
With line voltage: _______ V
_____ A
Scaled to nominal voltage
(maximum 500 A, see Additional conditions)
7.4Patient leakage current measurement
7.4.1For 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
7.4.2For 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
_____ A
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Chapter 3: Installation
No. Description Meas.
value
8 Functional test
8.1Functional test (T1 test) checked for proper performance.
8.2Ci-Ca option:
After successful completion of the test, screen M86 'Starting conditions' is
displayed.
8.3Power failure alarm executed.
9Final check
9.1Entries made in the Medical Device Register.
9.2Operating 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.
(Attach inspection sticker.)
Next
inspection date:
Comments:
Date: Signature: Stamp:
Yes
No
Fresenius Medical CaremultiFiltrateTM6/03.073-7
Page 60
Chapter 3: Installation
3.4Explanations 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.)
1Luer locks
2Venous clamp
3Filtrate bag hook
4IV pole and second IV pole (Ci-Ca module option)
5Potential equalization
6RS232 screwed connection
4
5
6
Fresenius Medical CaremultiFiltrateTM6/03.073-9
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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.
3-10Fresenius Medical CaremultiFiltrate TM6/03.07
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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 CaremultiFiltrate TM6/03.073-11
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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
1
2
Legend
1Saline bag with 0.9 % NaCl solution for heater
2Measuring plates for bag trays, left and right
3Heater bag with measuring probe
4Patient leakage current measurement: "AWT A" connector
Device leakage current measurement: Protective earth terminal
Symbol:
3
4
3-12Fresenius Medical CaremultiFiltrate TM6/03.07
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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.
Chapter 3: Installation
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 CaremultiFiltrate TM6/03.073-13
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Chapter 3: Installation
Re: 5.4.2 Patient leakage current measurement for degree of protection (CF)
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)
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
Confirming the test
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)
Test equipment used:
Type and serial number of the test equipment used.
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Assessing the test
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.
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 CaremultiFiltrate TM6/03.073-15
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Chapter 3: Installation
3.5Installing 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.
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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 CaremultiFiltrate TM6/03.073-17
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Chapter 3: Installation
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Chapter 4: TSC / TMC / Maintenance
4TSC / TMC / Maintenance
4.1Important Information Regarding the Procedure
Tester's qualificationThe 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
accessories
TSC/TMC/MA intervalsThe TSC/TMC/MA procedures for this system are to be performed after
The activities described in this technical document require the
availability of the necessary technical test equipment and accessories.
Any information on the specifications must be observed.
12 months.
Fresenius Medical CaremultiFiltrateTM6/03.074-1
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Chapter 4: TSC / TMC / Maintenance
4.2TSC / 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
TSC1.1Fuses accessible from the outside comply with the indicated values.
TSC1.2Labels and labeling are present and legible.
TSC1.3The mechanical condition permits further safe use.
TSC1.4There are no signs of damage or dirt.
TSC1.5The power cable shows no signs of damage.
MA1.6Replace the lithium battery of operating and safety processors (P.C.B. LP
244) every 4 years.________
2Extracorporeal components
TSC2.1Pump checked for stopping with open door.
Blood pump
Filtrate pump
Substituate pump
Dialysate pump
TSC2.2Pump rotors checked for damage and rolls for smooth running.
Blood pump
Filtrate pump
Substituate pump
Dialysate pump
TSC2.3The venous occlusion clamp closes after an air detector alarm.
TSC2.4The pressure of 2 bar applied in the venous bubble catcher may not drop
by more than 0.1 bar within 3 minutes.
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Chapter 4: TSC / TMC / Maintenance
Type No. Description Meas.
value
MA2.5Air 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.
MA2.6Pressure transducers: zero point and amplification as well as tightness
Tightness: 600 mmHg, drop max. 10 mmHg within 1 min
MA2.7Blood leak detector values checked for red coloration and dimness.
________
________
________
________
________
________
________
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Chapter 4: TSC / TMC / Maintenance
Type No. Description Meas.
value
3 Mechanical components
MA3.1Mechanical parts of scales checked for tight seat, parallelism and
smoothness.
Scale I
Scales II
Scales III
Scales IV
MA3.2Zero load, calibration and ball weight of scales checked.
Scale I
Zero load: display within a range from 60 g to 4500 g
Calibration: Test load on scales: display 5000 g ±1 g
Ball weight: display within a range from 43.8 g to 44.8 g
Scales II
Zero load: display within a range from 60 g to 4500 g
_______g
_______g
_______g
_______g
Calibration: Test load on scales: display 5000 g ±1 g
Ball weight: display within a range from 43.8 g to 44.8 g
Scales III
Zero load: display within a range from 60 g to 4500 g
Calibration: Test load on scales: display 5000 g ±1 g
Ball weight: display within a range from 43.8 g to 44.8 g
Scales IV
Zero load: display within a range from 60 g to 4500 g
Calibration: Test load on scales: display 5000 g ±1 g
Ball weight: display within a range from 43.8 g to 44.8 g
MA3.3Rotary selector checked for easy movement and tight fit
MA3.4Brakes of wheel assy. checked
_______g
_______g
_______g
_______g
_______g
_______g
_______g
_______g
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Chapter 4: TSC / TMC / Maintenance
Type No. Description Meas.
value
4 Ci-Ca module option: visual inspections
TSC4.1Colored markings of drop counters must be present.
TSC4.2Adhesive labels of citrate and calcium pumps are present and legible.
TSC4.3The mechanical condition permits further safe use.
TSC4.4There are no signs of damage or dirt.
TSC4.5Line holders must be present and undamaged.
5Ci-Ca module option: extracorporeal components
TSC5.1Citrate drop counter checked for proper function
TSC5.2Calcium drop counter checked for proper function
TSC5.3Line occlusion of the pumps checked.
Citrate pump (pressure loss max. 10 mmHg/min)
Calcium pump (pressure loss max. 10 mmHg/min)
________
________
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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!
TSC6.1Visual inspections performed according to item 1.
TSC6.2Protective earth resistance max. 0.3 (with power cable)______
TSC6.3Leakage 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
(maximum 500 A, see Additional conditions)
Device leakage current mains polarity 2: _______ A
With line voltage: _______ V
_____ A
Scaled to nominal voltage
(maximum 500 A, see Additional conditions)
TSC6.4Patient leakage current measurement
TSC6.4.1For 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
TSC6.4.2For 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
_____ A
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Chapter 4: TSC / TMC / Maintenance
Type No. Description Meas.
value
7 Functional test
TSC7.1Functional test (T1 test) checked for proper performance.
TSC7.2Ci-Ca module option
After successful completion of the test, screen M86 'Starting conditions' is
displayed.
TSC7.3Power failure alarm executed.
8Final check
TSC8.1Entries 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.
(Attach inspection sticker.)
Next
inspection date:
Comments:
Date: Signature: Stamp:
Yes
No
Fresenius Medical CaremultiFiltrateTM6/03.074-7
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Chapter 4: TSC / TMC / Maintenance
4.3multiFiltrate 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
TSC1.1Fuses accessible from the outside comply with the indicated values.
TSC1.2Labels and labeling are present and legible.
TSC1.3The mechanical condition permits further safe use.
TSC1.4There are no signs of damage or dirt.
TSC1.5The power cable shows no signs of damage.
2Extracorporeal components
TSC2.1Pump checked for stopping with open door.
Blood pump
Filtrate pump
Substituate pump
Dialysate pump
TSC2.2Pump rotors checked for damage and rolls for smooth running.
Blood pump
Filtrate pump
Substituate pump
Dialysate pump
TSC2.3The venous occlusion clamp closes after an air detector alarm.
TSC2.4The pressure of 2 bar applied in the venous bubble catcher may not drop
by more than 0.1 bar within 3 minutes.
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Chapter 4: TSC / TMC / Maintenance
Type No. Description Meas.
value
3 Ci-Ca module option: visual inspections
TSC3.1Colored markings of drop counters must be present.
TSC3.2Adhesive labels of citrate and calcium pumps are present and legible.
TSC3.3The mechanical condition permits further safe use.
TSC3.4There are no signs of damage or dirt.
TSC3.5Line holders must be present and undamaged.
4Ci-Ca module option: extracorporeal components
TSC4.1Citrate drop counter checked for proper function
TSC4.2Calcium drop counter checked for proper function
TSC4.3Line occlusion of the pumps checked.
Citrate pump (pressure loss max. 10 mmHg/min)
Calcium pump (pressure loss max. 10 mmHg/min)
________
________
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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!
TSC5.1Visual inspections performed according to item 1.
TSC5.2Protective earth resistance max. 0.3 (with power cable)______
TSC5.3Leakage 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
(maximum 500 A, see Additional conditions)
Device leakage current mains polarity 2: _______ A
With line voltage: _______ V
_____ A
Scaled to nominal voltage
(maximum 500 A, see Additional conditions)
TSC5.4Patient leakage current measurement
TSC5.4.1For 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
TSC5.4.2For 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
_____ A
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Chapter 4: TSC / TMC / Maintenance
Type No. Description Meas.
value
6 Functional test
TSC6.1Functional test (T1 test) checked for proper performance.
TSC6.2Ci-Ca module option
After successful completion of the test, screen M86 'Starting conditions' is
displayed.
TSC6.3Power failure alarm executed.
7Final check
TSC7.1Entries 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.
(Attach inspection sticker.)
Next
inspection date:
Comments:
Date: Signature: Stamp:
Yes
No
Fresenius Medical CaremultiFiltrate TM6/03.074-11
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Chapter 4: TSC / TMC / Maintenance
4.4Explanations 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.
4-12Fresenius Medical CaremultiFiltrate TM6/03.07
Page 83
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.)
1Luer locks
2Venous clamp
3Filtrate bag hook
4IV pole and second IV pole (Ci-Ca module option)
5Potential equalization
6RS232 screwed connection
Fresenius Medical CaremultiFiltrate TM6/03.074-13
Page 84
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
Fresenius Medical CaremultiFiltrate TM6/03.074-15
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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
1
2
Legend
1Saline bag with 0.9 % NaCl solution for heater
2Measuring plates for bag trays, left and right
3Heater bag with measuring probe
4Patient leakage current measurement: "AWT A" connector
Device leakage current measurement: Protective earth terminal
Symbol:
3
4
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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.
Fresenius Medical CaremultiFiltrate TM6/03.074-17
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Chapter 4: TSC / TMC / Maintenance
Re: 4.4.2 Patient leakage current measurement for degree of protection (CF)
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)
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
Confirming the test
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)
Test equipment used:
Type and serial number of the test equipment used.
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Assessing the test
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.
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
5Adjustment Instructions and Tests
5.1Service Tools
Part no.Description
M28 489 1Dongle ICD cable for programming the OP and SP
M28 060 1Measuring kit for measuring the patient leakage
current
M28 098 1Crosstalk Reduction Adapter
510 130 1ESC tester with measuring adapter for patient leakage
current
M30 770 1HMED pressure measuring instrument with case (set)
631 064 1Secutest VDE test device (without printer module)
M36 235 1Service Software, software set without hardware
M28 498 1Square wrench, housing door
675 845 1Hook test weight 5 kg / M1
630 360 1Equipotential bonding cable
M36 067 1Calibration kit for air detector
640 560 1Neutral filter for calibrating the optical detector
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Chapter 5: Adjustment Instructions and Tests
5.2Service Program
5.2.1Start
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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5.2.2Selecting the Language
5.2.3System Messages
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.
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.
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.
5.2.4Deactivating and Activating the Heparin Pump
Permits activation and deactivation of the optional heparin syringe.
Screen displayMachine status
Deactivate heparin syringeThe heparin syringe is currently
Activate heparin syringeThe heparin syringe is currently
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.
active.
not active.
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Chapter 5: Adjustment Instructions and Tests
5.2.5Filtrate Bag Monitoring Limit
Permits to set the monitoring limit to a value between 10 kg and 20 kg
on the filtrate scales.
Screen displayMachine status
Filtrate bag max. 5 kgCurrently, the monitoring limit is
Filtrate bag max. 10 kgCurrently, the monitoring limit is
Filtrate bag max. 20 kgCurrently, the monitoring limit is
5.2.6Dialysate Tubing Arrangement
Permits to switch from old to "Fin" dialysate tubing arrangement and
vice versa in the preparation mode.
set to 5 kg.
set to 10 kg.
set to 20 kg.
oldTubing 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
old
Tubing arrangement dialysate
"Fin"
Display of the old tubing
arrangement. Heater bag for
dialysate downstream of the
dialysate pump.
Display of the new tubing
arrangement. Heater bag for
dialysate upstream of the
dialysate pump.
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5.2.7Option MultiDataLink (mDL)
Chapter 5: Adjustment Instructions and Tests
This screen permits to set the multiDataLink parameters.
Activating and
deactivating mDL
DHCP active / inactiveThis soft key informs the mDL of whether a DHCP server is active in the
This soft key permits activation and deactivation of the optional mDL.
Screen displayMachine status
Deactivate mDLmDL is currently active.
Activate mDLmDL 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.
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-addressAutomatic0...255 adjustable
mDL-IP-subnetAutomatic0...255 adjustable
Gateway-addressAutomatic0...255 adjustable
Server-IP-addressAutomatic0...255 adjustable
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Chapter 5: Adjustment Instructions and Tests
DHCP active DHCP inactive
Activating/deactivating the
Patient/Case ID
Server-port0...65535 adjustable
Default value: 700
Host-port0...65535 adjustable
Default value: 2512
Technician's port0...65535 adjustable
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.
This soft key permits activation and deactivation of the optional
patient/case ID.
0...65535 adjustable
Default value: 700
0...65535 adjustable
Default value: 2512
0...65535 adjustable
Default value: 2511
Screen displayMachine status
Deactivate patient/case IDThe patient/case ID is currently
active
Activate patient/case IDThe patient/case ID is currently
not active
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5.2.8Taring and Calibrating the Scales
Chapter 5: Adjustment Instructions and Tests
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
RequirementThe 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 equipmentTest weight of 5000 g of accuracy class M1 or better.
RequirementThe 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
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
While calibration is in progress, the field selected is represented lightgreen. The time out is approx. 10 seconds.
5.2.9Calibrating the Pressures
rear part of the scale pan.
scale and press OK.
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
RequirementThe 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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The zero offset is made automatically. It is completed when the next
screen is displayed.
Calibrating the pressure transducers
Chapter 5: Adjustment Instructions and Tests
Test equipmentPressure gauge with a measurement range from 0350 mmHg
(0500 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
Using the rotary selector, set the value indicated by the pressure
Use the rotary selector to select the Entered? OK to confirm!
After calibration is completed, the system returns to the previous
screen.
Determining the setting of the DAC for detuning in the self-test
RequirementThe pressure transducers must have ambient pressure.
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.
gauge on the screen, i.e. in the Parterial field.
field and press OK.
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 lightgreen. 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
5-10Fresenius Medical CaremultiFiltrate TM6/03.07
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