Service Manual - Infusomat FMS
Service Manual - Infusomat FMS
Infusomat® fmS
Service Manual
0-
0
Index Page 11 - 1
Service Work The present manual is for your information only. The possession of
this manual does not authorize the performance of service work.
Service tasks may only be executed by persons, who
- have received appropriate training on the system from
B. Braun
- are included in the revision service
- possess the necessary test equipment and mechanical aids,
and
- fulfill the personal requirements (training and knowledge).
Technical Safety Checks The user is obliged to perform or to have performed the Technical
Safety Checks on those medial products for which these checks
have been prescribed by the manufacturer and to carry them out
according to the indications of the manufacturer as well as the
generally approved technical standards while adhering to the pe-
riods stated (§ 6 MP BetreibV).
B. Braun also recommends training on the Technical Safety
Checks, or to perform at least the steps indicated in the current
version of the manual, as:
- the TSC requires that the instructions in the manuals are ob-
served
- the manuals are a reference for measurements
- depending on the unit type, the Service Program must be
called which may lead to a dangerous unit condition in case
of inappropriate operation. Furthermore, a special service
connector may be necessary.
Current Versions This manual version corresponds to the state when the manual
was written. B Braun reserves the right to make technical modifi-
cations. The state of the revision is indicated by the index number
in the footer of every page.
Revision Service The possession of this manual does not automatically mean inclu-
sion in the revision service. You will be included in the revision
service after:
- technical training by B. Braun Melsungen or
- a written order placed with the sales department of B. Braun
(fee required).
Responsibility of the Manufacturer The manufacturer, person who assembles, installs or imports the
device can only be held responsible for safety, reliability and per-
formance if
- mounting, enhancements, new settings, changes or repairs
are carried out by duly authorized persons,
- the electrical installation in the corresponding room meets
the requirements of the VDE 0107, VDE 0100 part 710 or
IEC 60364-7-710 and the national standards,
- the device is used in accordance with the instructions for use
and the Service Manual,
- the Technical Safety Checks are performed at regular inter-
vals,
- a current manual which corresponds to the revision state is
used when carrying out maintenance, repair and service,
- the service technician takes part in the revision service,
- the technician has participated in a technical training course
for the specific B. Braun unit.
Quality Management B. Braun is certified in accordance with DIN EN ISO 9001 and
ISO 13485. This certification also includes maintenance and serv-
ice.
The unit has the CE label. The CE label confirms that the device
corresponds to the “Directive of the Council for Medical Products
93/42/EC” of June 14, 1993.
Checks and Repair Training may only be performed by B. Braun. The possession of the
manual does not authorize the performance of repairs. The in-
structions on electrostatic sensitive components (ESD standards)
must be observed.
After repair a device check or diagnosis is to be carried out.
Spare Parts and Test Equipment Only use original spare parts from the manufacturer. Do not
tamper with assembly groups which can only be exchanged com-
pletely. The spare parts required are listed in the repair descrip-
tions.
Service personnel are responsible for the calibration of their test
equipment. Original test equipment can be calibrated at the
works of B. Braun. Further information is available upon request.
Setting Off Additional notes and warnings are set off as follows:
Note
Is used for additional or special notes concerning information and
working steps.
CAUTION
Is used for working steps which may result in damage to the unit,
system or to a connected device.
! WARNING
IS USED FOR WORKING STEPS WHICH MAY RESULT IN PERSONAL
INJURY.
List of Abbreviations Abbreviations which are not generally known, but are used in this
manual, are listed below.
CC Computer Controlled
CLR Clear
Dig Digit
ESD Electrostatic Discharge
UA Unit Alarm
FuP Function Microprocessor
KuP Control Microprocessor
LCD Liquid Crystal Display
OIL Original Infusomat Line
PCA Patient Controlled Analgesia
TSC Technical Safety Check
TEMP Temperature
0- Contact Persons 0
Entry for Technical Training Application for a technical training course must be made via the
responsible representative.
Ordering of Spare Parts and Test Equipment Please contact your local B. Braun subsidary.
1- System Overview 1
Physical Construction The Infusomat® fmS is a compact volumetric peristaltic infusion
pump.
Standard delivery rate range 0.1 to 999.9 ml/h
The unit is operated via a membrane keyboard. It is equipped with
an LCD-display (liquid crystal display) for the display of the deliv-
ery rate and the operating support of the user. Two control LEDs
display alarms, and the running of the infusion pump.
MFC-socket
Door lock
LCD-display
Softkeys
Optical
interface
fm Recessed plug
Keyboard
Potential equalization
Air inline sensor
Drop sensor socket
Barcode label
Control LEDs Mains connection
Flow inhibitor
Barcode
A barcode label is attached to the left front side of new Infuso-
mat® fmS unit versions which can be retrofitted on previous de-
vices. This barcode label is used to read the serial and DIANET type
number via a scanner when the Infusomat® fmS is operated in an
fm-system.
Infusion Lines
The Infusomat® fmS can be operated with the Original Infuso-
mat® Line (OIL) and the Infusomat® Space Line. The lines are dis-
tinguished by the different silicone pump segments. They have to
be inserted in a different way; in addition the TSC differs.
Note
Operating the unit alternately with the Original Infusomat® Line
and the Infusomat® Space Line is not recommended. This could
result in incorrect dosage and inaccurate pressure alarms (not
complying with the specification)!
Note
Please observe the instructions listed in the appendix for adjust-
ing the Infusomat® fm/fmS to Space Line when using the Infuso-
mat® Space Line for the first time (see „Adjustment to Space
Line“ ➪ pg. A - 3).
Switch On
Service connector
Standard operation Special functions ... 3
plugged ... 1
- Dose calculation 5
- Bolus function
- Standby function
Set delivery rate Volume preselection Time preselection
- Drug change
- CC Mode 4
- Switch-off pres-
sure
Rate calculation - Drop control
- Piggyback 5
Start infusion - Battery capacity
- Data lock
- Alarm tone 6
Stop infusion
- Contrast setting
- Clock5
Change delivery rate …
Recall info
Recall Bolus
Fig.: 1 - 2
Voltage Supply The voltage supply is generated either directly from mains, via the
FM connector (14 V connection to the fluid manager system), or
via the MFC-connector (11 to 16 V) and as an internal supply via
the internal 7.2 V NiCD battery. The mains module is available in
three versions: 230 V, 220 / 230 / 240 V and 100 / 110 / 120 V. The
rated voltage has a tolerance of + 10% to – 15 %.
A voltage of 11 V to 18 V is available after transformation and rec-
tification. This voltage is fed to the battery charge circuit and the
unit supply. This is also valid for an external 12 V supply from the
MFC- or FM-connector. The FET V10 switches between the exter-
nal and the internal voltage supply. The transistor V10b works as
an ON/OFF switch for the operating voltages UPS, UMOT and +5V.
The +5V supplies the complete electronics including the double
channel microprocessor system. A window comparator constantly
monitors the +5V for undervoltage or overvoltage. The function is
checked during switch-on. The operating voltage UPS supplies the
stepper motor and the UMOT, the stepper motor drive.
The transistor V47 switches the operating voltage UMOT. In case
of an alarm the motor is switched off by V47. Additionally the
switching function of the transistor is checked during the switch-
on test.
The circuit has two separate assembly groups with separate sup-
ply voltages UBA and UBB. The ON/OFF circuit has a retriggerable
delay switch-off. A follow-up charging circuit drives the transis-
tor V10b.
The alarm logic (operating voltage UBB) is an RS latch. This is set
when the unit is running and activates the alarm circuit. The
alarm buzzer and driver are also driven by UBB. The ON/OFF circuit
is activated and the voltage supply is switched on by pressing the
ON/OFF key. The alarm latch is reset simultaneously. A function
test of the voltage monitoring, motor circuit and alarm activation
is performed. The voltage supply is maintained by cyclic self-hold-
ing pulses fed to the logic. The alarm latch is also activated.
Fig.: 1 - 4
Signal Table
Signal Meaning Signal Meaning
+5V Voltage supply electronic PKS2 Pump Head Sensor 2
5V-HT Overvoltage test PKSS Pump Head Sensor Control
5V-LT Undervoltage Test PRS Staff Call Relay Control
AK-I Battery Charge and Discharge Current PRS-F Staff Call Relay Function Channel
AK-LAD Battery Capacity ON/OFF PKSS Pump Head Sensor Control
AK-Test Battery Test PRS.RUF Staff Call Relay Control
ALA-UB Operating Voltage Alarm RDE Rate Display Enable
CS Chip Select RES Power on Reset
DI Data Input RES-F Reset Function Channel
DO Data Output RES-K Reset Control Channel
E/A-INT ON/OFF by Microprocessor RTS Return to Send (DIANET)
E/A-ST ON/OFF Status Rx Receive Data
E/A-TAS ON/OFF Key SCK Serial Data Clock
Mains Operation When the unit is connected to mains the unit supply voltage is
switched on for the duration of the switch-off delay time. If the
microprocessor recognizes a sufficient mains voltage for charg-
ing, the voltage supply is maintained. In this case only a battery
balance is carried out, because a key was not pressed. The current
battery capacity and the battery operting hours are displayed in
the LCD. The unit is switched off when the ON/OFF key is pressed
for at least 2 seconds. Thereby the self-holding is triggered and
the alarm latch is reset with a delay. After another 20 seconds the
unit is switched off, because the pulses are missing. If the Infuso-
mat® fmS is switched off in mains operation with the ON/OFF key,
the internal mains voltage is still present.
Battery Operation The battery function is monitored by the following data: charge
current, discharge current and time, and self-discharge time. In
battery operation the battery function is checked during switch-
on test. The theoretical load condition is read from the clock mod-
ule of the battery. Then the battery is connected to UPS and the
voltage is measured. If the minimum requirements are not
reached a battery alarm is activated.
Pump Unit The pump head is driven by a stepper motor. Each full step of the
motor is realized by 5 microsteps. The motor is driven by an FET
output stage. The function processor controls the motor with the
MS signal. A slot disc which is mounted on the pump head axle is
scanned by two light barriers (PKS1 and PKS2 signal). Thereby the
control microprocessor monitors the direction of rotation and
speed of the pump head.
The pump head position is also determined with the PKS2 signal.
The motor can therefore be accelerated during the withdrawal
phase. Thus a nearly pulse-free flow is realized in the lower deliv-
ery range (<100 ml/h). The total pump head cycles and running
time are available in the Service Program under history data.
Computer Interface The Infusomat® fmS is equipped with a computer interface. It can
be connected to the optical interface or via the MFC service con-
nector. To activate the computer operation please ask for a de-
tailed description from B. Braun.
Up to software version IFMC: DIANET
From software version IFMe, IFME on: DianetStar
Braun fluid manager system (fm system) The Infusomat® fmS can be operated as a stand-alone unit or in-
tegrated in an intensive care unit, e.g. the B. Braun fluid manager
system (fm system). It is integrated by simply snapping the unit
into the system.
Mains supply and data communication are automatically con-
nected. Thereby data acquisition and transmission to higher com-
puter system levels are possible.
Internal Assignment
Fig.: 1 - 5
Accessories General
Designation Ord. No.
Mounting clip for drop chamber ”TK 2000” . . . . . . . . 3477 3223
Mounting clip for drop chamber ”Intrafix air” . . . . . . 3477 3215
Drop sensor, complete . . . . . . . . . . . . . . . . . . . . . . . . . . 3450 578A
Short pole clamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0870 1644
Drop chamber holder . . . . . . . . . . . . . . . . . . . . . . . . . . . 3477 3088
Mains lead (200-240V~) . . . . . . . . . . . . . . . . . . . . . . . . 3450 2718
Mains lead (100-120V~) . . . . . . . . . . . . . . . . . . . . . . . . 3450 5423
Mains lead USA / CAN . . . . . . . . . . . . . . . . . . . . . . . . . . 3450 5393
Universal clamp, complete . . . . . . . . . . . . . . . . . . . . . . 3450 5857
Pole clamp (universal clamp, rotating) . . . . . . . . . . . . 3450 9054
2- Software 2
Software Update Designation Ord. No.
Update kit IFMC02003 . . . . . . . . . . . . . . . . . . . . . . . . . 3450 645A
Update kit IFMe02009 / IFME03009 . . . . . . . . . . . . . 3450 645H
MFC interface line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0871 1661
The higher digit always replaces the lower digit for the revision
level, e.g. IFME02009 replaces IFME02008.
Units with an old software version (e.g. IFMC02001) can be up-
Position 1 2 3 4 5 6 7 8 9 dated to the new software version IFME03009.
Digit I F M E 0 3 0 0 7 When the software group changes the unit functions are
changed, too. Therefore unit users must be informed (e.g. instruct
the user and exchange the instructions for use – software coding
Revision level
(e.g. IFME) is to be found on the cover page of the instructions for
Hardware identification use.)
Software group
Infusomat® fmS Note
Note
Mark the unit after having updated the software! The new soft-
ware version must be clearly recognizable.
Note
Software updates must be reported to B. Braun for registration.
Observe the notes of the update program and the supplements!
Note
Before an update, please make sure that the latest software ver-
sion is available to you.
IFMC02002
- Error elimination
at Bolus special function
at staff call on the fm system
- Optimized air sensor evaluation
IFMC02003
- EMC optimized
- New error code FF16, defective membrane keyboard
IFMe02002
- Preselected volume and time counted down to 0
- Interface changed to DIANET Star
(not compatible with Dianet)
- New special function dose calculation
- New special function Piggyback
- New special function clock
- Storage of alarms in case of malfunctions, which can be re-
called in the Service Program, function 230
IFME03002
Only controller board with loudspeaker (see „Controller Board“
➪ pg. 4 - 5).
Like IFMe02002 and in addition:
- Alarm volume can be set
- History function
IFMe02003
- Dianet Star corrected
IFME03003
- Additionally History corrected
- Log of volume delivered
- New event: normal mode / piggy mode
IFMe02004 / IFME03004
- Optimized dose calculation
- New language “Hungarian” in language group E
IFMe02005 / IFME03005
- Cyclical battery test
- Retaining or deleting last dose calculation when unit is
switched off, can be set in the Service Program
IFMe02006 / IFME03006
- Optimized switch-off cycle of Service Program
IFMe02007 / IFME03007
- Reset the battery capacity from 0 mAh to 1 mAH in the event
of a negative battery test result.
- Reset the battery voltage acceptance thresholds from 7.55 V
to 7.35 V.
IFMe02008 / IFME03008
- New processor (for production only).
IFMe02009 / IFME03009
- Upgrade kit for IFMe02008 / IFME03008
Text box
Fig.: 2 - 2
Table 2 - 1
Table 2 - 2
3- Service Program 3
Structure of the Service Program
Service connector
plugged
Switch On
Short display:
software version,
user language
Service Program
activated
Software version Operating hours Air inline sensor Service language Scale factor
100.0 200.0 300.0 400.0 510.0
Drug Battery op. hours Pressure sensor User language Air inline sensor
110.0 210.0 310.0 410.0 520.0
Delivery rate
460.0
Air alarm
470.0
Dianet mode
Display 1)
480
Fig.: 3 - 1
Contrast Setting
1. Select ”Contrast Setting” with the SM key. The softkey sym-
bols will flash.
2. Set display contrast with the (+) or (-) key.
3. Return to main menu with END.
2. Select ”Mechanical”.
3. Return to main menu with END.
A too low pump speed is indicated in the display by ”Pressure
Alarm” with underlined stars.
Fig.: 3 - 2
FUNCTION
END Jumps to the initial function
GR+ Selects group
FU+ Selects function in the
activated group
OK Activates the selected function or if
necessary skips to the sub-functions
with NEXT
Fig.: 3 - 3
Note
Disconnect the unit from mains for at least 30 seconds after ter-
mination of the Service Program (memory is deleted). Then the
unit can be switched on again.
Fig.: 3 - 5
Note
If the 5 to 15 digits are not reached, the pressure sensor unit must
be mechanically adjusted (see „Pressure Sensor“ ➪ pg. 4 - 14).
The activation of the "10 minutes off” alarm is only permissible, if:
- the staff call is connected and
- the Infusomat® fmS has an attention label (label drawing no.
M007100000F04).
1. OK activates the function.
2. Select alarm tone with NEXT.
3. Acknowledge with YES.
4. Return to initial function with END.
Staff Call Function 430.0
Different staff call modes can be selected:
- Dynamic with OFF Alarm
- Dynamic without OFF Alarm
- Static without OFF Alarm
For further details see staff call line in the instructions for use.
An additional switch-on pulse (YES/NO) can be activated for each
mode to test the staff call unit.
1. OK activates the function.
2. Select staff call type with NEXT.
3. Acknowledge with YES.
4. Return to initial function with END.
Calibration
Note
All safety relevant parameters are set by the manufacturer. If
these parameters are changed, a new calibration must be per-
formed with calibrated test equipment.
Note
Compatibility between controller board and pump must be
checked before acknowledgement. Only press YES if pump corre-
sponds to controller board.
Note
See instructions for use for detailed information.
4- Unit Elements 4
4.1 Mains Fuses Designation Ord. No.
Fuse T 0.16 A for 200 / 230 / 240 V
(10 pcs.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3477 2847
Fuse T 0.315 A for 100 / 110 / 120 V
(10 pcs.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3477 0534
Fuse holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3450 0979
Note
Only use recommended fuses.
Exchange
1. Press the expansion clamps at the fuse holder on the recessed
mains plug with a screw driver in direction of the arrows and
pull out fuse holder.
2. Replace blown fuses and press in fuse holder. Only use rec-
ommended fuses.
Check
Safety check, functional check.
Check
Perform switch-on test in battery operation and check the battery
running time, if necessary.
Exchange
1. Open door and unlatch the spring holder.
2. Remove countersunk screw and press out the mounting by
pressing the holder for the door lock.
3. Remove door lock in an upward direction and exchange.
4. Assembly is done in reverse order.
Check
Pump unit check (only mechanical occlusion pressure).
Spring holder
Fig.: 4 - 2
Exchange
Tools: Pin punch 1.8 mm, pin punch 6 mm, 4 mm gauge
1. Open door and remove hinge pin with pin punch (1.8 mm)
from below. Do not lose torsion spring.
2. Disassemble pump cover.
3. Insert torsion spring in new pump cover. Insert hinge pin with
pin punch (6 mm) from above.
4. Check pressure sensor with 4mm gauge in the Service Pro-
gram, and calibrate, if necessary.
Check
Safety check.
4 x M4x8
Fig.: 4 - 4
The controller boards (raw material no. 3810 7651 and 3810 7996)
are completely compatible.
This allows older units to be upgraded with the new features
(loudspeaker, volume control, and history function) without any
problems. In this case the controller board must be ordered as new
part.
Exchange
1. Remove battery (see „Battery“ ➪ pg. 4 - 1).
2. Dismount cover (see „Housing and Handle“ ➪ pg. 4 - 4).
3. Press snap-in pin together at the distance sleeves and remove
board carefully.
4. Pull off connector (see figure).
5. Exchange board or buzzer.
* Language Group:
A German, French, Dutch, Italian
B English, Dutch, Spanish, Castellano
C Danish, Norwegian, Swedish, Finnish
D Spanish, Portuguese, English, Turkish
E Czech, Polish, German, English
Note
If ”Calibration Defective” is displayed after having exchanged the
controller board, check whether the correct board (risk of mix-up)
was assembled.
Check
Safety check, functional check.
Note
On devices as from serial number 142758, the MFC connector
board is supplied grounded on the potential equalization bolt via
the green/yellow cable instead of on the fm recessed plug via the
blue cable, eliminating the red cable and fm recessed plug..
Fig.: 4 - 6
M4x8
Fig.: 4 - 8
Rear panel
M4x8
Fig.: 4 - 9
Fig.: 4 - 10
Note
On devices with serial number 142758 and higher, the fm recessed
plug is no longer required.
Note
The voltage selection for switchable power supplies is at the fuse
element.
Check
Fig.: 4 - 12 3 X Torx M3x10 Safety check, functional check.
Exchange
Tools: Pin punch
1. Remove battery (see „Battery“ ➪ pg. 4 - 1).
2. Dismount cover (see „Housing and Handle“ ➪ pg. 4 - 4).
3. Disassemble pump cover (see „Pump Cover“ ➪ pg. 4 - 3).
4. Loosen countersunk screws by piercing a screwdriver through
the caps and remove caps.
Reed sensor
5. Press Reed sensor out of holder on the rear side, see Fig.: 4 -
(rear side)
14.
Snap-in pin
6. Press both snap-in pins inwards (rear side top and bottom).
(rear side)
Then remove front frame to the front.
7. Remove flow inhibitor with pressure spring and Reed sensors
Fig.: 4 - 13 and assemble in new front frame.
8. Insert the seal. Assembly is done in reverse order. Snap-in pins
manually. Insert Reed sensor and fasten cables firmly with
cable ties.
Check
Safety check, pump unit check.
Exchange
1. Remove battery (see „Battery“ ➪ pg. 4 - 1).
M3x6 (or PT 30x8) 2. Dismount cover (see „Housing and Handle“ ➪ pg. 4 - 4).
Note
Reed sensor Be sure that the cable of the Reed sensor and air inline sensor do
Cable tie not hinder the function of the pressure sensor and the monitoring
of the motor speed (slot disc).
The complete pump unit (pump without motor, pump cover, mem-
Fig.: 4 - 14
brane, boards) was calibrated by B.Braun. After a complete ex-
change the unit data and user data must be entered in the Service
Program again as the data memory is on the pump board:
8. Enter unit and user data in the EEPROM.
- Serial number according to the type plate
- DIANET type number according to the type plate
If necessary enter:
- Drug name
- Ward identification
- Alarm tone
Note
If data is not entered, ”Calibration data faulty” may be displayed
after the unit is switched on again.
Check
Safety check, pump unit check.
The pressure sensor consists of the light barrier board with EEP-
ROM and the pressure sensor board with holder. Coil core and
bending element are screwed to this holder. Both boards are con-
nected via a flat cable.
1. Dismount rear panel (see „Rear Panel“ ➪ pg. 4 - 6) or pump
unit (see „Pump Unit“ ➪ pg. 4 - 12).
2. Pull off the connecting cable to the microprocessor board.
Plain
washer 3. Loosen and remove screw (1) of the light barrier board.
4. Loosen screw (2) of the pressure sensor and remove it togeth-
er with plain washer and serrated lock washer. Then remove
Serrated lock washer
pressure sensor with pressure sensor board and light barrier
Screw (2) Pressure sensor with board.
pressure sensor board
Do not loosen screw 5. Fit pressure sensor with pressure sensor- and light barrier
Fig.: 4 - 15 board.
Note
Make sure that the pressure sensor slide can smoothly run in the
guides and that the coil core can move inside the coil.
Note
Pull nut slightly out of the pressure sensor housing.
! WARNING
Service mode is only authorized for service tasks.
DANGER OF INJURY IF USED ON THE PATIENT!
- Never operate the unit with plugged in service connector or
service cable on the patient.
- First switch the unit off before any further use after working
with the service connector.
Note
Calibration weights are required to calibrate the pressure sensor.
An alignment with infusion lines is not permitted.
Check
Safety check, functional check.
Note
Shielded air inline sensors are installed from serial no. 34504 on.
Note
Be sure that the cables of the Reed sensor and air inline sensor do
not hinder the function of the pressure sensor and the monitoring
of the motor speed (slot disc).
Check
Air inline sensor
After exchange of the air inline sensor, please check:
- Air value
Fig.: 4 - 16 - Water value
- Calibration value (alarm threshold), adjust if necessary
Safety check, functional check.
Note
Do not kink either of the flex cables. Push the contacts to the
stopper of the zero insertion force connector and lock in same po-
sition.
Fig.: 4 - 18
Note
Destroy the type plate delivered.
Check
Check that serial number and pump symbol in the plain text field
of the barcode label correspond with the type plate on the pump
of the Infusomat® fmS.
Barcode label
Fig.: 4 - 19
Exchange
1. Disassemble all parts as described before and exchange frame
with seal plate.
Check
Electrical safety, functional check, pump unit check.
Note
Depending on the setting, the measurement
should be performed only with one of the
two lines.
(Part 1 of 2)
Delivery accuracy
Ambient temperature 20 ... 25 °C
Delivery rate: 250 ml/h
Measured volume: 25 ml
❒ Divergence (± 5%) ________ %
Drop sensor
Delivery rate: 400 ml/h
❒ Drop sensor alarm, occlusion
❒ Drop sensor alarm, flow
Battery test
Operation mains/battery/mains:
❒ Uninterrupted operation
Switch on unit without mains connection
❒ Self-test is executed
(Part 2 of 2)
6- Maintenance 6
It is recommended every 2 years. In addition to the technical safe-
ty inspection, the following assemblies/components are to be
checked:
1. Check rubber feet and if necessary exchange.
2. Check easy running of the pump cover, lock mechanism and
door.
3. Check easy running of the flow inhibitor, clean and if neces-
sary exchange pressure springs.
4. Check seal membrane and if necessary exchange.
5. Check the drop sensor optics and spring mechanics and clean,
if necessary.
6. Open unit. Internal visual inspection. Clean seal surfaces and
if necessary exchange seal strip.
7. Check mechanical occlusion pressure and if necessary cali-
brate.
8. Check electronic occlusion pressure and if necessary calibrate
(see „Pressure Sensor“ ➪ pg. 4 - 14).
9. Assemble and seal unit ready for operation.
Observe the Service Manual and the instructions for use. All measured values are to
be documented. Accessories used should be included in testing. Make exclusive use
of calibrated measuring equipment.
Note
Depending on the setting, the mea-
surement should be performed only with
one of the two lines.
Drop sensor
Delivery rate: 400 ml/h
Drop sensor alarm, occlusion
(< 5s) ______s
Battery test
Operation main/battery/mains
Uninterrupted operation
Switch on unit without mains connection
Self-test is executed
Original Infusomat® Line (OIL) MFC staff call line Calibrated for usage of:
Original Infusomat® Line
Infusomat® Space Line __________________________
(OIL)
Manfacturer: __________________________ Infusomat® Space Line
(Note the stickers and retrofit,
_________________ __________________________
if necessary)
Type: __________________________
_______________________ __________________________
Manufacturer:
________________
Type:
_______________________
Fig.: 8 - 1
Electrical Safety The values to be measured are specified in the TSC (see „Techni-
according to IEC / EN 60601-1 cal Safety Check (TSC)“ ➪ pg. 7 - 1). The measured values are
or VDE 0750 and VDE 0751 to be recorded.
1. Disconnect all connection and interface cables from the de-
vice.
Note
Do not use the foot stand assembly screws as alternative meas-
urement points.
Insulation Resistance
1. Measurement with 500 V between the short-circuited mains
connectors and the protective conductor.
Switch on Unit
1. Switch on unit and check the following details:
- Self-test
- Audible alarm
One short and afterwards two short tones
- Status displays
LEDs (red, green) light up for a short moment
- LCD lighting
Operation
1. Open door.
Pump cover must automatically open when the unit door is
opened.
2. Insert the Original Infusomat Line (OIL). If the unit is designed
for an Infusomat® Space Line, then insert an Infusomat®
Space Line.
3. Close door.
The door must lock smoothly and close correctly at the top
Fig.: 8 - 2 and bottom.
4. Carry out infusion with intermediate bolus and press all but-
tons at least once.
Infusion and bolus are performed and all buttons trigger the
function desired.
5. Plug MFC service connector on the MFC socket.
6. Trigger a staff call (e.g. open pump cover during operation).
The red LED in the MFC service connector lights up.
- if ”dynamic” is set, 1 sec.
- if ”static” is set, until the alarm is acknowledged.
Check the MFC staff call line if installed.
7. Press the alarm button.
The current alarm is suppressed for 2 minutes.
Test Setup
Perform test setup with the subassemblies listed below, please see
also Fig.: 8 - 3:
An electronic manometer should be used for the measurement
described hereafter.
Note
If a mechanic manometer is used instead values which are approx.
100 mbar lower are to be expected. Proceed as follows.
Note
The liquid level in the container must be approx. 80 cm above the
lower edge of the device.
Reference height
80 ± 2 cm
- Original Infusomat® Line
(new, can be used for the complete TSC incl. functional check)
(1 piece)
or
- Infusomat® Space Line
10 ml air (new, can be used for the complete TSC incl. functional check)
(1 piece)
2 1
Fig.: 8 - 4
! WARNING
The electronic pressure control is deactivated after the safety
clamp was checked.
DANGER OF INJURY IF THE DEVICE IS DEPLOYED IMMEDIATELY
AFTERWARD.
- Switch the device off so that the electronic pressure control
is reactivated after a restart.
Drop Sensor
1. Set delivery rate according to the TSC.
2. Connect drop sensor to the device.
3. Start infusion according to the specifications of the TSC.
4. Squeeze off line above the pump. The drop sensor triggers an
alarm.
5. Squeeze the drop chamber bottom part, to generate a jet. The
drop sensor triggers an alarm immediately.
5. Document values.
6. Enter a delivery rate of 250 ml/h and a volume of 250 ml.
7. Start infusion.
8. Generate an air bubble of approx. 0.4 ml (approx. 56 mm
length of line with air) in the supply line to the pump. An
alarm is triggered when the air bubble is detected.
9. Insert a line filled with air in the device and close operating
unit, or disconnect the line at the container and “vent” in or-
der to remove the water out of the line.
10. Read off test value of the air inline sensor via the function
300.0 “Air inline sensor” in the Service Program (see „Air In-
line Sensor Function 300.0“ ➪ pg. 3 - 5).
11. Read off value after approximately 10 seconds and compare
with the air value specifications of the TSC.
12. Read off threshold value via the function 520.0 “Air inline
sensor” in the Service Program (see „Air Inline Sensor Func-
tion 520.0“ ➪ pg. 3 - 10).
13. Compare value with the threshold value specifications of the
TSC.
Battery Check
1. Disconnect the device from the mains supply during opera-
tion.
2. The symbol for the mains plug on the LC display goes off. An
error message is not triggered and operation of the unit is
continued.
3. Reconnect unit to the mains.
4. The symbol for the mains plug is displayed on the LC display.
An error message is not triggered and operation of the unit is
continued.
5. Switch device off.
6. Disconnect unit from mains.
7. Switch on unit.
A self-test is carried out.
11 - Index 11
A M
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 11 Mains fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 1
Adjustment to Space Line . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 3 Mains operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 7
Air inline sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 17 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1
Alarm circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 8
O
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 3
Occlusion pressure,
Approved software versions . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 1
electronic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 9
Assignment, internal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 10
mechanical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 9
B Operating unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 18
Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 1
P
Battery operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 8
Physical construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 1
Block diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 4
Pressure sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 14
C Procedural instructions on the TSC . . . . . . . . . . . . . . . . . . . . 8 - 1
Checks after repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 1 Pump cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 3
Contact Persons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 - 9 Pump unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 8, 4 - 12
Controller board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 5
R
Current versions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 - 5
Rear panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 6
D Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 - 6
Default values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 6 Revision documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 1
Door lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 2 Revision service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 - 5
E S
Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 - 1 Service Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 1
Error messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 3 Service Program,
activate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 3
F
quit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 3
Frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 19
Software update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 1
Front frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 11
Space Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A - 3
Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 4
Spare parts list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 - 1
Functional inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 - 2
Special tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 - 1
H
T
Handle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 4
Technical Safety Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1
Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 4
Technical Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 - 5
L Test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 - 1
List of abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 - 8 TSC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 - 5, 7 - 1
V
Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 - 1
Voltage supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 5
A- Appendix A
Revision Service-Documentation Version 2.0
This manual has been completely revised. The most important
changes are listed below:
- Changed manual structure
- New TSI list
- New paragraph pressure sensor (exchange / calibration)
- New test equipment for pressure sensor
- New software
- New spare parts
- Total list of spare parts
Version 2.1
- New TSI list
- New controller board
- New software
Version 2.2
This version was approved by B. Braun on 19.04.2006.
The most important changes of this version are listed below:
- New software
- New Service Program functions
- New spare parts
- Changed occlusion pressure data
Version 2.3
This version was approved by B. Braun on 18.02.2008.
The most important changes of this version are listed below:
- New software
- Possible use of the Infusomat® Space line
- New TSC
- Revised procedural instructions on the TSC
Version 2.4
This version was approved by B. Braun on 07.12.2009.
The most important changes of this version are listed below:
- New software
- New TSC
- Revised procedural instructions on the TSC
Version 2.5
This version was approved by B. Braun on 31.01.2011.
The most important changes of this version are listed below:
- New TSC
- Revised procedural instructions on the TSC
- Revised list of spare parts
- New appendix: Adjustment to Space Line
Version 2.6
This version was approved by B. Braun on 28.06.2011.
The most important changes of this version are listed below:
- Changed procedure for inspecting the delivery rate for cali-
bration
- Removal of OIL test infusion line
Current Information
References
- Service Manual Infusomat® fm, version 2.3 or later
- Service Manual Infusomat® fmS, version 2.3 or later
How to proceed
1. Plug in Service connector, switch on pump and activate the
service program.
2. Delivery rate
- Select function 510 „Calibration scale factor“ and acti-
vate with „ok“.
- Confirm the indication scale factor = xxx. „change ?“
with „YES“.
- Note current setting, add 12 and enter the new scale fac-
tor. Confirm with „YES“.
3. Electronic pressure sensor
- Select function 540 „calibration occlusion level“ and ac-
tivate with „ok“.
- Note value 1 for „pressure level low“ and add 20. Delete
the current value with “C” and enter the new calculated
value.
- Note value 2 for „pressure level middle“ and add 20. De-
lete the current value with “C” and enter the new calcu-
lated value.
- Confirm both modifications with „YES“.
4. Close the service program with “END” and “Save changes ?”
with „yes“ and switch the Infusomat fm/fmS off.
5. Label the pump with the sticker Infusomat Space Line
(34521285).
Caution!
Never use a pump with a service connector attached while a pa-
tient is connected!
After every use with a service connector attached the pump needs
to be switched off.
Important notes
Inform the users about the changes in use according to the at-
tachment and make the attachment available for them in a copy.
(see „Attachement“ ➪ pg. A - 6).
The adjustment described in this instruction is designed to com-
pensate the offset between Original Infusomat® Line and Infuso-
mat® Space Line. It does not describe the calibration of a pump.
A calibration only needs to be performed in case the measure-
ments within the next technical safety check make it necessary.
Sticker A Sticker B
Attachement
By adjusting the Infusomat® fm or Infusomat® fm/S to the Infu-
somat® Space Line it is permitted to use the lines listed in the at-
tachment. Also there is additional information concerning patient
safety and line insertion mentioned in the attachment. Very im-
portant is to take care of the direction of flow as well as to make
sure the line is not twisted.
Make the attachment available to the users by selecting the right
language and providing them a copy of the respective page.
Danish
Dutch
English
Finnish
French
German / Deutsch
Italian
Norvegian
Polish
Portuguese
Spanish
Swedish
Inspection of delivery accuracy for calibration Depending on the adjustment of the unit, a new Original Infuso-
mat® line or a new Infusomat® Space Line is to be used!
Requirements:
Reference
height - Check setup. Restrictions or constrictions affect the result.
80 ± 2 cm - The pump has been stopped after the idle phase such that the
delivery cycle begins without delay when starting the meas-
urement.