This Service Manual is available under
the following part number:
Languages of this ManualDesignationPart No.
The complete Service Manual contains
the following pages:
DesignationPart No.
Service Manual Infusomat® fmS, English . . . . . . . . . . 8713 9124
Service Manual Infusomat® fmS, German . . . . . . . . . . 8713 9123
Page 0-1 to page 0-10
Page 1-1 to page 1-12
Page 2-1 to page 2-8
Page 3-1 to page 3-10
Page 4-1 to page 4-20
Page 5-1 to page 5-2
Page 6-1 to page 6-2
Page 7-1 to page 7-4
Page 8-1 to page 8-8
Page 9-1 to page 9-2
Page 10-1 to page 10-4
Page 11-1 to page 11-2
Page A-1 to page A-2
0 - 2 Infusomat® fmS 2.3 gb
Page 3
0
0 - Table of Contents
Important Preliminary RemarksService Work Page 0 - 5
Technical Safety Checks Page 0 - 5
Current Versions Page 0 - 5
Revision Service Page 0 - 5
Quality Management Page 0 - 6
Checks and Repair Page 0 - 6
Notes on ESD Page 0 - 6
Spare Parts and Test Equipment Page 0 - 7
Setting Off Page 0 - 7
List of Abbreviations Page 0 - 8
Contact PersonsTechnical Training Page 0 - 9
Entry for Technical Training Page 0 - 9
Ordering of Spare Parts and Test Equipment Page 0 - 9
Service Hotline Page 0 - 9
Return of Spare Parts and Test Equipment Page 0 - 9
Safety Officer
Service ProgramStructure of the Service Program Page 3 - 1
Additional Functions with
Plugged Service Connector Page 3 - 2
Start / Quit the Service Program Page 3 - 3
Unit Data Page 3 - 3
History Data Page 3 - 4
Test Page 3 - 5
Unit Modifications Page 3 - 6
Calibration Page 3 - 9
Revision DocumentationRevision Service-Documentation Page A - 1
Current Information Page A - 1
0 - 4 Infusomat® fmS 2.3 gb
Page 5
0
0 - Important Preliminary Remarks
Service WorkThe 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 ChecksThe 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 VersionsThis manual version corresponds to the state when the manual
was written. B
cations. The state of the revision is indicated by the index number
in the footer of every page.
Revision ServiceThe 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).
Braun reserves the right to make technical modifi-
Responsibility of the ManufacturerThe 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,
Infusomat® fmS 2.3 gb 0 - 5
-
Page 6
0
Fig.: 0 - 1
Important Preliminary Remarks
-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 intervals,
-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.
Quality ManagementB. 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.
Braun unit.
Checks and RepairTraining 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.
Notes on ESDSemiconductors can be destroyed by electrostatic discharge. Es-
pecially MOS components can be damaged by interference from
electrostatic fields, even without discharge via contact. This type
of damage is not immediately recognizable. Unit malfunctions
can even occur after a longer period of operation.
Each workstation must be equipped according to the recommendations with the necessary static protective measures, if ESD
components or boards are handled.
Each workstation must be equipped with a conductive table surface. The conductive surface, the soldering iron or the soldering
stations must be grounded via protective resistors.
Chairs must be of antistatic design. The floor or floor mats should
be of electrically conductive material.
Personnel must wear conductive wristbands which are connected
to a central ground potential via protective resistors, e.g. the
ground contact of a wall outlet. Furthermore it is recommended
that personnel wear cotton clothing and electrically conductive
shoes to prevent electrostatic charge.
-
0 - 6 Infusomat® fmS 2.3 gb
Page 7
0
Note
CAUTION
WARNING
Important Preliminary Remarks
Spare Parts and Test EquipmentOnly 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 Section 9.
Service personnel are responsible for the calibration of their test
equipment. Original test equipment can be calibrated at the
works of B.
Setting OffAdditional notes and warnings are set off as follows:
Is used for additional or special notes concerning information and
working steps.
Braun. Further information is available upon request.
-
Is used for working steps which may result in damage to the unit,
system or to a connected device.
IS USED FOR WORKING STEPS WHICH MAY RESULT IN PERSONAL
INJURY.
References to chapters are shown as follows
(see “Setting Off“ ➨ pg. 0 - 8)
References to figures and tables are shown as follows
Fig.: 2 - 3 or Table 2 - 1
References to item numbers in figures are shown as follows
(Fig.: 1 - 1 / Item 1)
In this case “Fig.: 1 – 1“ is the figure number and “Item 1“ the item
number within the figure.
When the Service Manual is stored as pdf-file, these references
are displayed green. Click with the mouse button on a reference
to jump to the corresponding source.
Menu commands are described as:
Menu
File
.
Infusomat® fmS 2.3 gb 0 - 7
Page 8
0
Important Preliminary Remarks
List of AbbreviationsAbbreviations which are not generally known, but are used in this
manual, are listed below.
CCComputer Controlled
CLRClear
DigDigit
ESD Electrostatic Discharge
UAUnit Alarm
FuPFunction Microprocessor
KuPControl Microprocessor
LCD Liquid Crystal Display
OIL Original Infusomat Line
PCA Patient Controlled Analgesia
TSC Technical Safety
Check
TEMP Temperature
0 - 8 Infusomat® fmS 2.3 gb
Page 9
0
pg:0 - 10
0 - Contact Persons
Technical TrainingVia local representative.
Entry for Technical TrainingApplication for a technical training course must be made via the
responsible representative.
Ordering of Spare Parts and Test EquipmentPlease contact your local B. Braun subsidary.
Return of Spare Parts and Test EquipmentB. Braun Melsungen AG
Schwarzenberger Weg 73-79
Wareneingang Werk C
34 212 Melsungen
Germany
Safety Officer
(§ 30 MPG)
TranslationBrückner GmbH, Germany
Dr. Ludwig Schütz
e-mail: ludwig.schuetz@bbraun.com
Infusomat® fmS 2.3 gb 0 - 9
Page 10
Contact Persons
0
For your notes:
0 - 10 Infusomat® fmS 2.3 gb
Page 11
1
Fig.: 1 - 1 Unit design Infusomat® fmS
Handle
Door lock
Control LEDs
Keyboard
LCD-display
Softkeys
Guide for short pole clamp
Drop sensor socket
Flow inhibitor
Air inline sensor
Drop sensor
Mains connection
Potential equalization
fm Recessed plug
Optical
MFC-socket
interface
Peristaltic pump
Barcode label
1 - 12
1 - System Overview
Physical ConstructionThe 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.
-
Infusomat® fmS 2.3 gb 1 - 1
Barcode
A barcode label is attached to the left front side of new Infusomat® fmS unit versions which can be retrofitted on previous devices. 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.
Page 12
System Overview
1
WARNING
Note
Infusion Lines
The Infusomat® fmS can be operated with the Original Infusomat® Line (OIL) and the Infusomat® Space Line. The lines are distinguished by the different silicone pump segments. They have to
be inserted in a different way; in addition the TSC differs.
OPERATING THE UNIT ALTERNATELY WITH THE ORIGINAL INFUSOMAT® LINE AND THE INFUSOMAT® SPACE LINE IS NOT RECOMMENDED.
Please observe the “Instruction for Technical Service - Adjustment
to Space Line“ when using the Infusomat® Space Line for the first
time.
1 - 2 Infusomat® fmS 2.3 gb
Page 13
1
Operation Flow Chart
Fig.: 1 - 2
Switch On
Standard operation
Service connector
plugged ...
1
Special functions ...
3
Set delivery rate
Volume preselection
Time preselection
Rate calculation
Start infusion
Stop infusion
Recall info
Change delivery rate …
Recall Bolus
1
See Service Program diagram
2
Only when preselected time or preselected volume has expired
3
Please pay attention to activation in Service Program
4
Only available with IFMC
5
From software IFMe, IFME on
6
From software IFME on
KOR Mode
2
-Dose calculation
5
-Bolus function
-Standby function
-Drug change
-CC Mode
4
-Switch-off pressure
-Drop control
-Piggyback
5
-Battery capacity
-Data lock
-Alarm tone
6
-Contrast setting
-Clock
5
System Overview
Infusomat® fmS 2.3 gb 1 - 3
See instructions for use for detailed information.
Page 14
1
Fig.: 1 - 3 Block diagram
System Overview
FunctionTwo independent software-controlled microprocessor systems
control and monitor the hardware. On the basis of their functions,
they are defined respectively as a control and a function proces
sor. Both systems work with independent clock frequencies and
have access to different program and data memories. All safetyrelevant functions are handled by both microprocessors and the
results are counter checked (CF- and FC-latch).
The input via the keyboard is fed to both processors. Additionally
the acknowledgement signal of the ON/OFF key is fed to the
mains power supply logic (voltage E/A-TAS). The function proces
sor has also access to this logic via E/A-INT.
Description of the voltage signals (see „Signal Table“ ➪
p. 1 - 6).
-
-
1 - 4 Infusomat® fmS 2.3 gb
Page 15
1
System Overview
Voltage SupplyThe 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
rectification. 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 ex
ternal 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 switchon test.
The circuit has two separate assembly groups with separate supply 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.
-
-
Infusomat® fmS 2.3 gb 1 - 5
Page 16
System Overview
1
Fig.: 1 - 4
Signal Table
SignalMeaningSignalMeaning
+5VVoltage supply electronicPKS2Pump Head Sensor 2
5V-HTOvervoltage testPKSSPump Head Sensor Control
5V-LTUndervoltage TestPRSStaff Call Relay Control
AK-IBattery Charge and Discharge CurrentPRS-FStaff Call Relay Function Channel
AK-LADBattery Capacity ON/OFFPKSSPump Head Sensor Control
AK-TestBattery TestPRS.RUFStaff Call Relay Control
ALA-UBOperating Voltage AlarmRDERate Display Enable
CSChip SelectRESPower on Reset
DIData InputRES-FReset Function Channel
DOData OutputRES-KReset Control Channel
E/A-INTON/OFF by MicroprocessorRTSReturn to Send (DIANET)
MISOSerial Data Output InterfaceTSCLDrop Sensor Clock
MOSISerial Data Input InterfaceTSEDrop Sensor Receiver
MOTEINMotor ONTSRDrop Sensor Regulation
MSMotor ControlTSSDrop Sensor Control
P-ENAPort EnableTxTransmit Data
PH0Phase 0UBA, UBBSupply Voltage for Alarm, On/Off Logic, RTC
PH1Phase 1UPSSwitched Operating Voltage UB
PH2Phase 2UPS-MUPS Measurement Line
PH3Phase 3UMOTSupply Voltage of Motor Drive
PKSPump Cover SensorUMOT-MUMOT Measurement Line
PKS1Pump Head Sensor 1URTCSupply Voltage Clock Module
Table 1 - 1 Signal table (Part 2 of 2)
Mains OperationWhen 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.
-
-
Infusomat® fmS 2.3 gb 1 - 7
Page 18
1
System Overview
In mains operation battery function is checked during the switchon test. Therefor the charge and discharge current are measured
and the charging of the battery is interrupted for the duration of
measurement.
Battery OperationThe 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 switchon 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.
-
Alarm CircuitThe alarm generation consists of:
-Standstill of pump due to switch-off of MS (motor circuit)
and UMOT (motor operating voltage)
-Audible alarm due to the drive via ALA-AK (control channel)
or via ALA-UB. The alarm volume is about 65dBA.
-Optical alarm. Is displayed in the LCD- and a separate LEDdisplay. Additionally the set rate flashes with AAA.A.
-Staff call via the MFC staff call cable.
The user must check the optical and audible alarm during the
switch-on test. An alarm must be activated to test the staff call
alarm of the Infusomat® fmS, e.g. open pump cover during oper
ation.
Pump UnitThe 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.
-
-
1 - 8 Infusomat® fmS 2.3 gb
Page 19
1
System Overview
Mechanical Occlusion Pressure:
The Infusomat® fmS has a linear peristaltic pump. This pump has
12 slides which are driven by a camshaft.
When the pump cover is closed, the pump tube is squeezed (occlusion) by at least one of the slides, independent of the pump
head position. The complete pump unit is mounted behind the
front panel in the cabinet frame. The hinges and the locking bow
for the pump cover are led through the front panel. The pump cov
er is automatically closed when the operating unit door is closed.
The slides are pressed against the pump cover by a spring system
in the pump unit. Thereby a delivery pressure is realized and me
chanically limited by the springs.
If the pressure limit is exceeded there is no volume delivery. The
drop sensor activates an alarm. If one of the springs fails, the
spring system will ensure that an unsafe condition cannot occur
(free flow). The two remaining springs ensure an appropriately
high occlusion pressure.
-
-
Electronic Occlusion Pressure:
The electronic occlusion sensor is mounted on the output side of
the pump. A spring pressure loaded slide is seated on the infusion
line. An increase of pressure in the infusion line leads to a deflec
tion of the coil core via the pressure slide. The depth of immersion
is measured inductively. When a preset pressure threshold is
reached the pump drive is switched off, and an alarm is activated.
The electronic occlusion pressure is a single channel circuit. In
case of a failure, the mechanically limited maximum pressure can
be reached.
Motor Switch-Off by Both Processors:
Function processor: MS signal to switch off the motor drive. Control processor: MOTEIN signal to switch off the drive of the
motor operating voltage.
Computer InterfaceThe 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 detailed description from B. Braun.
-
-
Up to software version IFMC: DIANET
From software version IFMe, IFME on: Dianet
Infusomat® fmS 2.3 gb 1 - 9
Star
Page 20
1
Fig.: 1 - 5
System Overview
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 connected. Thereby data acquisition and transmission to higher computer system levels are possible.
Internal Assignment
1 - 10 Infusomat® fmS 2.3 gb
Page 21
1
AccessoriesGeneral
DesignationOrd. No.
Mounting clip for drop chamber ”TK 2000” . . . . . . . . 3477 3223
Mounting clip for drop chamber ”Intrafix air” . . . . . . 3477 3215
The higher digit always replaces the lower digit for the revision
level, e.g. IFME02007 replaces IFME02006.
Units with an old software version (e.g. IFMC02001) can be updated to the new software version IFME03007.
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
(e.g. IFME) is to be found on the cover page of the instructions for
use.)
Do not use an update program on Windows NT systems.
Mark the unit after having updated the software! The new software version must be clearly recognizable.
Only update from old to new software versions, never in reverse
order (e.g. never update from IFMC02003 to IFMC02001!).
All units used in one ward should have the same software status
and basic setup to avoid operator mistakes.
Software updates must be reported to B. Braun for registration.
Observe the notes of the update program and the supplements!
Infusomat® fmS 2.3 gb 2 - 1
Page 24
2
Software
Approved Software VersionsIFMC02001
-Basic software
(Must not be used any more. Please contact the Technical
Service of B. Braun).
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
(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 recalled in the Service Program, function 230
IFME03002
Only controller board with loudspeaker (see „Controller Board“
➪ p. 4 - 5).
Like IFMe02002 and in addition:
-Alarm volume can be set
-History function
IFMe02003
-Dianet Star corrected
Star
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
2 - 2 Infusomat® fmS 2.3 gb
Page 25
2
Software
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.
Infusomat® fmS 2.3 gb 2 - 3
Page 26
Software
2
Fig.: 2 - 2
7 segment display
Text box
Error Messages and Alarms
Alarms of the function processor 80c535 are displayed in the text
box of the LCD-display. Alarms of the control processor 68HC11
are displayed in the 7 segment display. The alarms help to trou
bleshoot unit malfunctions. As not all malfunctions can be considered, unit malfunctions with different messages, which are not
listed, can be displayed, or there may be no message.
Detected unit alarms are displayed in the text box as ”Unit
Alarms” in the selected language. Additionally the error number is
displayed in the text box.
-
Function Processor 80c535
Text BoxDescription
100defective RAM memory
101UMOT cannot be switched on
102UMOT still switched on despite overvoltage
103UMOT still switched on despite MOTEIN=0
104UMOT still switched on despite undervoltage
105ON/OFF key pressed longer than 14 sec
106defective air sensor (calibration value?)
107defective program memory
108defective program flow
109different number of pump head cycles
110different keyboard gaps between 80c838 and 68hc11
111different program versions between 80c535 and 68hc11
112defective program flow
113testbit!=0 out of switch-on test
116defective program memory - text
117defective program memory - text does not match with program
118reset during active operation
119defective ROM
Table 2 - 1
2 - 4 Infusomat® fmS 2.3 gb
Page 27
2
7 Segment Display Description
FF01dummy for test
FF02battery not present / missing battery current
FF03defective RAM memory
FF04defective program memory
FF05defective program memory
FF06calibration data error from EEPROM
FF07pump head cycle not plausible
Software
Control Microprocessor 68hc11
FFxx is displayed in the 7 segment display with flashing dots. FFxx
is the error code.
SM menuInterval Bolus doseOff_______________________
Online rate settingOn_______________________
Double rate entryOff_______________________
User dataSwitch-off pressurehigh_______________________
Contrastoptimum contrast_______________________
CC Address2) 1_______________________
Drug0_______________________
Data lockOff_______________________
Standby time24h 00min_______________________
Drop controlOn_______________________
_______________________
1)
From software IFMe, IFME on
2)
No longer available in software IFMe, IFME
2 - 6 Infusomat® fmS 2.3 gb
Page 29
2
Software
Menu ItemDefaultCustomer Setting
Bolus keyOn_______________________
Bolus rate999.9 ml/h_______________________
Calibration dataAir sensor calibration value182 mVmust not be changed
Scale factor54_______________________
Unit specific dataDIANET type no.depending on unit_______________________
Unit No.depending on unit_______________________
Operating hoursdepending on unit_______________________
Battery hoursdepending on unit_______________________
Number of pump head cyclesdepending on unit_______________________
Infusomat® fmS 2.3 gb 2 - 7
Page 30
Software
2
For your notes:
2 - 8 Infusomat® fmS 2.3 gb
Page 31
3
Fig.: 3 - 1
Service connector
plugged
Switch On
Special function
(see operating
flow diagram)
Standard operation
(see operating
flow diagram)
Short display:
software version,
user language
Service Program
activated
Group:
Unit data
Group:
History data
Group:
Test
Group:
Unit modification
Group:
Calibration
Ward identification
120.0
Operating hours
200.0
Air inline sensor
300.0
Service language
400.0
Scale factor
510.0
Software version
100.0
Drug
110.0
Serial number
140.0
DIANET type no.
150.0
Battery op. hours
210.0
Pump head
cycles
220.0
Alarms
230.0
Pressure sensor
310.0
User language
410.0
Alarm tone
420.0
Staff call
430.0
Special function
440.0
Menu
450.0
Delivery rate
460.0
Air alarm
470.0
Air inline sensor
520.0
Pressure stage
540.0
Pump data
550.0
Delete dose values
490
History
2)
560.0
1
From software IFMe, IFME on
2
From software IFME on
Dianet mode
Display
1)
480
3 - 10
Structure of the Service Program
3 - Service Program
Infusomat® fmS 2.3 gb 3 - 1
Page 32
Service Program
3
Additional Functions with
Plugged Service Connector
Software Version and User Language
1. Plug service connector on MFC socket at the rear of the unit.
2. Switch on unit and keep the ON/OFF button pressed
(for max. 15 s).
3. The software version and user language are displayed in the
LCD-display.
4. The unit is switched on when the ON/OFF button is released.
5. ** appears in the LCD-display if the service connector is
plugged.
Two LEDs are integrated in the service connector:
-green = Power supply active
-red = Alarm
The following conditions are activated:
-The operating alarms are muted.
-All special functions are accessible (including the disabled).
-The special functions are slightly modified. (Example: SM
battery capacity has keys for 0 min/32 min presetting).
-The battery capacity display switches between the nominal
and the actual capacity. If the maximum battery capacity is
not reached ”?” will be displayed before the new nominal ca
pacity.
-
Contrast Setting
1. Select ”Contrast Setting” with the SM key. The softkey symbols will flash.
2. Set display contrast with the (+) or (-) key.
3. Return to main menu with END.
Disabling the Pressure Sensor (Occlusion Pressure Mechanical)
The electronic pressure monitoring can be deactivated to check
the mechanical occlusion pressure.
1. Select ”Occlusion Pressure” with the SM key.
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.
3 - 2 Infusomat® fmS 2.3 gb
Page 33
3
Note
Fig.: 3 - 2
Fig.: 3 - 3
Start / Quit the Service ProgramActivate the Service Program
1. Plug service connector on MFC socket at the rear of the unit.
- ** appears in the display.
2. Select ”Service Program” with the SM key. When the service
program is activated the red alarm LED flashes. The LED dis
plays the code number of the selected group and function.
FUNCTION
ENDJumps to the initial function
GR+Selects group
FU+Selects function in the
activated group
OKActivates the selected function or if
necessary skips to the sub-functions
with NEXT
Service Program
-
Quit the Service Program
1. Press END in the main menu. - A data storage query is activated: ”Save changes? Yes / No”.
Y / N terminates the Service Program.
Press END to jump to the last function.
2. Switch off unit and remove service connector.
Disconnect the unit from mains for at least 30 seconds after termination of the Service Program (memory is deleted). Then the
unit can be switched on again.
Unit DataSoftware VersionFunction 100.0
1. Select sub-functions with NEXT.
2. The current software version is displayed in the LCD-display:
- User program version with date
- Language with text version. Further languages with (+).
- Service Program version
- Service language with text version
3. Return to initial function with END.
Infusomat® fmS 2.3 gb 3 - 3
Page 34
Service Program
3
Fig.: 3 - 4
Drug NameFunction 110.0
Memory for maximum 10 drugs and 20 characters per name.
1. Display stored drug names with NEXT key.
2. Delete displayed entry with CLR.
3. Press YES to modify a drug name:
Move cursor to character with NEXT.
Select new character from line 3 with << or >>.
4. Repeat procedure for each character.
5. Return to initial function with END.
Ward IdentificationFunction 120.0
Enter and display of a ward specific unit identification. Permanent
display if the unit is connected to mains and switched off.
1. Delete displayed entry with CLR. Press YES to enter modifications:
Move cursor to character with NEXT.
Select new character from line 3 with << or >>.
2. Repeat procedure for each character.
3. Return to initial function with END.
Serial NumberFunction 140.0
The displayed serial number must correspond with the number on
the unit type plate, as this number is used in interface mode.
1. YES activates the entry mode. Enter via the numeric keyboard.
2. YES stores the changed or new number.
3. Return to initial function with END.
DIANET Type NumberFunction 150.0
The displayed serial number must correspond with the number on
the unit type plate, as this number is used in the interface mode.
1. YES activates the entry mode. Enter via the numeric keyboard.
2. YES stores the changed or new number.
3. Return to initial function with END.
History DataOperating Hour CounterFunction 200.0
1. OK activates the display.
2. Return to initial function with END.
Battery Operating HoursFunction 210.0
1. OK activates the display.
3 - 4 Infusomat® fmS 2.3 gb
Page 35
3
Fig.: 3 - 5
0Battery empty (battery alarm)
1Pump cover open
2Drop alarm
3Air alarm
4 Occlusion alarm
5Expired standby time
6CC alarm (interface)
7KOR end alarm
8 to 14free
15Operating alarm
Bit1514131211109876543210
Code1000000000000010
Example for alarm ”Pump cover open”
Service Program
2. Return to initial function with END.
Pump Head CyclesFunction 220.0
Display of the pump head cycles (delivered volume).
1. OK activates the display.
2. Return to initial function with END.
Operating AlarmsFunction 230.0
The last 20 operating alarms can be recalled.
They are displayed as 16 bit binary codes and each bit position can
be set from 0 to 1.
1. OK activates the alarm display.
2. Display operating alarms -01 to -20 with the (+) and (-) key.
3. Delete operating alarms with CLR.
TestAir Inline SensorFunction 300.0
4. Return to initial function with END.
Unit alarms will also be displayed from software version IFMe,
IFME on
After exchange check the function of the air inline sensor.
See TSI-List for permissible check values (see „Technical Safety
Check TSC“ ➪ p. 7 - 1).
1. Press OK. The received signal amplitude is displayed as a
measured value.
(The test value with NEXT is not important).
2. Insert an infusion line filled with air and check the maximum
permissible air value.
3. Insert an infusion line filled with fluid and check the minimum permissible water value.
4. Return to initial function with END.
Infusomat® fmS 2.3 gb 3 - 5
Page 36
Service Program
3
Note
Pressure SensorFunction 310.0
Test Equipment
Calibration gauge 4 mm
(see „Test Equipment and Special Tools“ ➪ p. 9 - 1)
1. Push in the bottom slide of the finger pump.
2. Activate function with OK button.
3. Open unit door.
4. Note value measured by the pressure sensor (actual value).
5. Insert the 4 mm calibration gauge and close unit door.
6. The measured value read on the pressure sensor must be 5 to
15 digits above the value noted.
7. Quit function with END.
If the 5 to 15 digits are not reached, the pressure sensor unit must
be mechanically adjusted (see „Pressure Sensor“ ➪ p. 4 - 14).
Unit ModificationsService LanguageFunction 400.0
English or German can be selected.
1. OK activates the function.
2. Select language with NEXT.
3. Acknowledge with YES.
4. Return to initial function with END.
User LanguageFunction 410.0
Four user languages per language group are available (depending
on software).
1. OK activates the function.
2. Select language with NEXT.
The language no. and text version are displayed.
3. Acknowledge with YES.
4. Return to initial function with END.
Alarm Tone Function 420.0
Different alarm modes can be selected:
-Single stage
-A ”10 minutes off” alarm can be selected.
In this mode the audible alarm is activated with a delay of 10
minutes.
3 - 6 Infusomat® fmS 2.3 gb
Page 37
3
Fig.: 3 - 6
Service Program
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 CallFunction 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.
Special FunctionsFunction 440.0
Special functions can be activated in the Service Program, which
are then available on the user interface. Deactivated special func
tions will not be displayed. The SM softkey will not be displayed
in standard operation, if all special functions are deactivated. Special functions to be selected, see
1. OK activates the function.
2. Select special functions with NEXT.
3. Activate / deactivate the respective function with YES/NO.
4. Return to main menu with END.
Fig.: 1 - 2.
-
Infusomat® fmS 2.3 gb 3 - 7
Page 38
Service Program
3
MenuFunction 450.0
The availability of menus on the user interface can be set.
-Double rate entry
-Online rate entry
-Interval Bolus
1. OK activates the function.
2. Activate / deactivate the decimal function with NEXT.
3. Acknowledge with YES.
4. Return to main menu with END.
Delivery Rate Function 460.0
The maximum and minimum delivery rates can be set. Range of
adjustment of the delivery rate: 0.1 to 999.9 ml/h
1. OK activates the function.
2. Select min./max. delivery rate with NEXT.
3. Acknowledge with YES.
4. Enter value with a numeric key.
5. Acknowledge with OK.
6. Return to initial function with END.
Air AlarmFunction 470.0
The air inline sensor sensitivity of the air rate alarm in ml/h (total
air alarm) and of the maximum air bubble in ml (single bubble)
can be adjusted.
Setting range air rate: 0.5 to 3.5 ml/h
Setting range air bubble: 0.01 to 0.3 ml/h
1. OK activates the function.
2. Select air rate (ml/h) or air bubble (ml) with NEXT.
3. Acknowledge with YES.
4. Enter value with a numeric key.
5. Acknowledge with OK.
6. Return to initial function with END.
3 - 8 Infusomat® fmS 2.3 gb
Page 39
3
Calibration
Note
Service Program
Dianet Mode Display Function 480.0
When operated with DianetStar the respective DianetStar-mode
(CA, CC, CD) with address 01, e.g. mode CA and address 01 is dis
played by: „###CA01###“.
The duration of the display after the last data transmission can be
set between 0 and 255 seconds.
Deleting Dose DataFunction 490.0
When this function is activated operation can be continued with
the dose data of the previous therapy.
-
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.
Scale FactorFunction 510.0
The scale factor can be set in the limits 40 to 99 digits. Every digit
step is equivalent to a 0.5 % modification of the delivery rate. An
increase of the scale factor reduces the pump speed, and a de
crease increases the pump speed.
A test infusion line (OIL test infusion line with an Infusomat® fmS
adjusted for the Original Infusomat® line, and a Space calibration
line with an Infusomat® fmS set for the Infusomat® Space Line is
to be used for determining the correction value
ment and Special Tools“ ➪ p. 9 - 1).
1. OK activates the function.
2. The value can be changed with the entry keyboard (see „De-
livery Accuracy“ ➪ p. 8 - 6).
3. Acknowledge with YES.
4. Return to initial function with END.
(see „Test Equip-
-
-
5. Quit the Service Program and save changes with YES.
6. Switch on unit and check delivery rate (see „Delivery Accu-
racy“ ➪ p. 8 - 6).
If necessary repeat the delivery rate measurement.
Infusomat® fmS 2.3 gb 3 - 9
Page 40
Service Program
3
Note
Note
Air Inline SensorFunction 520.0
Alignment or check of the air inline sensor value (alarm threshold)
(see „Air Inline Sensor“ ➪ p. 4 - 17).
1. OK activates the function.
2. Press OK again to activate the air inline sensor value.
3. The value can be changed with the entry keyboard.
4. Acknowledge with YES.
5. AIR SENSOR IS SET acknowledges the entry.
6. Return to initial function with END.
7. Quit the Service Program and save changes with YES.
Occlusion LevelFunction 540.0
Calibrate (see „Pressure Sensor“ ➪p. 4 - 14).
Pump DataFunction 550.0
Compatibility between controller board and pump must be
checked before acknowledgement. Only press YES if pump corre
sponds to controller board.
History Function 560.0 *
The history function can be activated or deactivated.
1. Press OK key twice to activate the function.
2. Select the history function with NEXT.
3. ON activates the function. The history protocol memory is initialized (the current software version and the serial number
are registered).
Press OFF key to deactivate the function. The history protocol
memory is deleted.
4. Return to initial function with END.
See instructions for use for detailed information.
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 recommended fuses.
Check
Safety check, functional check.
4.2BatteryDesignationOrd. No.
Battery incl. connector 1.2 AH / 7.2 V and holder. . . . 3450 2556
Exchange
1. Switch off unit and disconnect from mains.
2. Loosen screw, open battery compartment cover and remove
battery.
3. Pull off battery connector.
4. Assembly is done in reverse order.
5. After having exchanged the battery the Infusomat® fmS must
be connected to mains, before switching on the unit. Thereby
the charge and discharge currents are aligned.
6. Charge battery (16 h).
Defective batteries must be orderly disposed of, e.g. send back to
B. Braun Melsungen AG, Wareneingang.
Check
Perform switch-on test in battery operation and check the battery
running time, if necessary.
Controller board with buzzer, raw material no. 3810 7651, soft-
ware IFMC, can be updated to software IFMe:
Language Group*New PartExchange
AOrd. No.:3450 1967 Ord.No.:3488 0844
BOrd. No.:3450 1975 Ord.No.:3488 0852
COrd. No.:3450 1983 Ord.No.:3488 0860
DOrd. No.:3450 1991 Ord.No.:3488 0879
EOrd. No.:3450 2033 Ord.No.:3488 0887
Controller board with loudspeaker, volume control and history
function, raw material no. 3810 7996, software IFME:
Language Group*New PartExchange
AOrd. No.:3450 8759 Ord. No.:3488 1019
BOrd. No.:3450 8708 Ord. No.:3488 1190
COrd. No.:3450 8716 Ord. No.:3488 1204
DOrd. No.:3450 8724 Ord. No.:3488 1212
EOrd. No.:3450 8732 Ord. No.:3488 1240
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“ ➪ p. 4 - 1).
2. Dismount cover (see „Housing and Handle“ ➪ p. 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
Infusomat® fmS 2.3 gb 4 - 5
D Spanish, Portuguese, English, Turkish
E Czech, Polish, German, English
Page 46
Unit Elements
4
Note
Fig.: 4 - 6
6. Assembly is done in reverse order. Be careful with the optical
components. Insert board in the lower guide parallel to the
base plate. (Otherwise problems with the optical interface
can occur.)
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.
4.7Rear PanelDesignationOrd. No.
Rear panel with screws (M3) and seal . . . . . . . . . . . . . 3450 1860
Motor with pinion for finger pump. . . . . . . . . . . . . . . . 3450 1924
Exchange
1. Remove battery (see „Battery“ ➪ p. 4 - 1).
2. Dismount cover (see „Housing and Handle“ ➪ p. 4 - 4).
3. Disassemble front frame (see „Front Frame“ ➪ p. 4 - 11).
4. Loosen motor screws, pull off motor connector and remove
motor from pump unit.
Do not loosen the assembly screw on the lower pressure sensor
board! Otherwise the pump has to be recalibrated with a 4mm
gauge.
5. Pull off connector from controller board.
6. Press down snap-in pins (from the inside) and tilt pump forward and unhinge.
7. Assembly is done in reverse order.
Be sure that the cable 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).
The complete pump unit (pump without motor, pump cover,
membrane, boards) was calibrated by B.Braun. After a complete
exchange the unit data and user data must be entered in the Serv
ice 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
4 - 12 Infusomat® fmS 2.3 gb
If necessary enter:
-Drug name
-Ward identification
-Alarm tone
-Delivery rate min./max.
Page 53
4
Note
Unit Elements
-Air alarm: air bubbles in ml and air rate in ml/h respectively
-User language
-Special functions (ON/OFF)
-Menu
-Staff call type
If data is not entered, ”Calibration data faulty” may be displayed
after the unit is switched on again.
9. After ending the Service Program save the data.
The counters for operating hours, battery operation and pump
head cycles are reset to zero when the pump unit is exchanged. If
”Calibration data faulty” is displayed, select the Service Program
and quit with ”Save? Yes”.
(only delivered when a pressure
calibration device is available)
Exchange
The pressure sensor unit is mechanically very sensitive. It must not
be dismounted, which means that the pressure sensor board and
the spring element must not be detached from the pressure sensor
support (plastic part). Make sure that the movement of the coil
core inside the coil is not hindered.
The pressure sensor consists of the light barrier board with EEPROM 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“ ➪ p. 4 - 6) or pump
unit (see „Pump Unit“ ➪p. 4 - 12).
2. Pull off the connecting cable to the microprocessor board.
4 - 14 Infusomat® fmS 2.3 gb
3. Loosen and remove screw (1) of the light barrier board.
4. Loosen screw (2) of the pressure sensor and remove it together with plain washer and serrated lock washer. Then remove
pressure sensor with pressure sensor board and light barrier
board.
5. Fit pressure sensor with pressure sensor- and light barrier
board.
Make sure that the pressure sensor slide can smoothly run in the
guides and that the coil core can move inside the coil.
6. Calibrate pressure sensor:
a) Switch on unit and call in the pressure sensor reading in
the Service Program
310.0“ ➪ p. 3 - 6)
b) Loosen screw (2) on the side of the pressure sensor unit
(2.5 mm Allen key).
(see „Pressure Sensor Function
-
Page 55
4
Note
Note
Unit Elements
c) Push pressure sensor with pressure sensor board to the
rear until stopper.
d) Move lower slide of the finger pump rearwards.
e) Note down pressure sensor value.
f)Insert 4 mm calibration gauge.
g) Push pressure sensor with pressure sensor board slightly
forward.
h) Tighten screw (2).
The measured value read on the pressure sensor must be
5 to 15 digits above the value noted.
Pull nut slightly out of the pressure sensor housing.
i)After calibration return to the initial function with END.
j)Select SAVE NO. (Do not actuate the YES key.)
k) Switch off unit.
7. Assembly is done in reverse order.
8. Check the user data and reenter, if necessary, as data was
saved in the EEPROM of the exchanged light barrier board.
9. Calibrate pressure sensor:
Calibration weights are required to calibrate the pressure sensor.
An alignment with infusion lines is not permitted.
a) Clean the pump front side.
b) Place the Infusomat® fmS without mains lead and drop
sensor and the service connector inserted horizontally
(front facing upwards) in the cellular packing of the cal
ibration device.
c) Switch on unit and call in the pressure sensor reading in
the Service Program
310.0“ ➪ p. 3 - 6).
d) Open pump cover.
e) Fasten holders for the calibration weights under the
pump cover and let snap in at the locking bow.
f)Position weight 1 (100 g) for 400 mbar carefully in the
holder on the pressure sensor. The weight must be placed
without any friction in the holder.
g) Note down measured value.
h) Repeat steps f) and g) with weight 2 (128 g) for 800 mbar
and weight 3 (166 g) for 1200 mbar.
(see „Pressure Sensor Function
-
Infusomat® fmS 2.3 gb 4 - 15
Page 56
Unit Elements
4
i)Remove weight and holder and do not save data.
j)Call in calibration of pressure stage (function 540) in the
Service Program.
k) Enter the calibration values via the keyboard and ac-
knowledge with ”yes”.
l)Quit Service Program and save data.
m) Register the changed pressure values in the unit book.
n) Check the electronic occlusion pressure (see „Pressure
2. Dismount cover (see „Housing and Handle“ ➪ p. 4 - 4).
3. Dismount controller board (see „Controller Board“ ➪
p. 4 - 5).
4. Disassemble front frame (see „Front Frame“ ➪ p. 4 - 11).
5. Press the complete sensor from behind and out of the frame.
6. Insert new sensor and fasten cables firmly with cable ties.
Shielded air inline sensors are installed from serial no. 34504 on.
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
After exchange of the air inline sensor, please check:
-Air value
-Water value
-Calibration value (alarm threshold), adjust if necessary
Safety check, functional check.
Infusomat® fmS 2.3 gb 4 - 17
Page 58
4
Note
Note
Fig.: 4 - 16
Support plate
Zero insertion
Cable is preformed
LCD module
force connector
Fig.: 4 - 17
Frame operating unit
Hinge pin
6 x PT2.5x14
Unit Elements
4.12 Operating UnitDesignationOrd. No.
Membrane keyboard with support plate and seal . . . . 3450 1797
2. Clean adhesion surface with an alcoholic cleaning agent and
let dry.
3. Loosen barcode label from the base material and stick it on.
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.
according to IEC / EN 60601-1
or VDE 0750 and VDE 0751
3. Functional Inspection
Pressure limitation, mechanical
(Reference values measured with
electronic pressure sensor)
❒ With original Infusomat® line
❒ P
❒ P
❒ With Infusomat® Space line
❒ P
❒ Value P
❒ P
Safety clamp (flow inhibitor)
❒ P
min
Delivery accuracy
Ambient temperature 20 ... 25 °C
Delivery rate: 250 ml/h
Measured volume: 25 ml
❒ Divergence
max
min
max
by min. 0.10 bar higher
max
than pressure level, high, electronic
min
(Part 2 of 2)
Drop sensor
Delivery rate: 400 ml/h
❒ Drop sensor alarm, occlusion
❒ Drop sensor alarm, flow
Air inline sensor
Delivery rate: 250 ml/h
❒ Water value
❒ Air alarm
❒ Air value
❒ Threshold value
Battery test
Operation mains/battery/mains:
❒ Uninterrupted operation
Switch on unit without mains connection
❒ Self-test is executed
Observe the procedure information (see „Procedural Instructions
on the TSC“ ➪ p. 8 - 1)!
5 - 2 Infusomat® fmS 2.3 gb
Page 63
6
6 - 2
6 - Maintenance
It is recommended every 2 years. In addition to the technical safety 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 necessary 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 calibrate.
8. Check electronic occlusion pressure and if necessary calibrate
(see „Pressure Sensor“ ➪ p. 4 - 14).
9. Assemble and seal unit ready for operation.
Infusomat® fmS 2.3 gb 6 - 1
Page 64
Maintenance
6
For your notes:
6 - 2 Infusomat® fmS 2.3 gb
Page 65
7 - 4
Checklist for Technical Safety Check – Every 24 Months
Unit: Infusomat® fmS
Manufacturer: B. Braun Melsungen AG
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 equip
ment.
Article No.Unit No.Year of ProcurementStock No.
Visual InspectionElectrical Safety
❒ Infusomat® fmS:
Cleanliness, completeness, damage and
faults affecting safety
Particularly:
❒ Damage to and readability of the
labels
❒ Completeness, damage and
readability of the additional labels
on an Infusomat® fmS set for the
Infusomat® Space Line
❒ Pump sealing diaphragm
❒ Membrane keyboard
❒ Rubber feet
❒ Operating unit
❒ Locking mechanism of the pump
❒ Original Infusomat Line (OIL)
❒ Infusomat® Space Line
(Note the stickers and retrofit, if
necessary)
Test result:
Defects found which could endanger patients, users or third parties: Yes No
Measures to be taken: Repair
___________________
Special features / documentation:
Inspection performed by:
Unit handed over on:
To:
Date / Signature:
Next deadline for TSC:
M670 00 00 92 F04 C 3891 2189 (GB)
7 - 4 Infusomat® fmS, 2.3 gb
Sheet 4 of 4
Page 69
8
Fig.: 8 - 1
8 - 8
8 - Procedural Instructions on the TSC
Visual Inspection1. Check the Infusomat® fmS and accessories for cleanliness.
2. Check the Infusomat® fmS and accessories for completeness
and check configuration. Pay special attention to the follow
ing parts:
a) Check the special additional labels of the Infusomat®
fmS adjusted for the Infusomat® Space Line, please see
Fig.: 8 - 1.
3. Check the Infusomat® fmS and its accessories for damage
and the labels for readability. Pay special attention to the fol
lowing parts:
a) Pump sealing diaphragm
b) Membrane keyboard
-
-
c) Rubber feet
d) Operating unit
e) Lock mechanism of the pump cover
f)Flow inhibitor
g) Mains plug connector
h) MFC plug connector
i)Check fuse values
A fuse with T 0.315 A must be installed for devices for
100/110/120 V.
A fuse with T 0.16 A must be installed for devices for
200/230/240 V.
Infusomat® fmS 2.3 gb 8 - 1
Page 70
Procedural Instructions on the TSC
8
Note
Electrical Safety
according to IEC / EN 60601-1
or VDE 0750 and VDE 0751
The values to be measured are specified in the TSC (see „Techni-
cal Safety Check TSC“ ➪ p. 7 - 1). The measured values are to
be recorded.
1. Disconnect all connection and interface cables from the device.
Protective Conductor Resistance
1. Measure between the protective conductor of the mains cable and the following parts:
-Potential equalization bolt
-Bolt for door lock
-Left-hand contact (when looking at the connector) of the FM
connector
-Unit housing:
a) If the unit is not sealed countersunk screw at the rear of
the unit.
b) If the unit is sealed, remove lacquer from one of the holes
in the foot stands.
c) Document largest value.
Do not use the foot stand assembly screws as alternative measurement points.
Insulation Resistance
1. Measurement with 500 V between the short-circuited mains
connectors and the potential equalization bolt.
Earth Leakage Current
1. Measure the earth leakage current without single fault condition (NC = Normal Condition) incl. mains cable.
2. Measure the earth leakage current without single fault condition (NC = Normal Condition) incl. mains cable with reversed polarity.
3. Document largest value.
8 - 2 Infusomat® fmS 2.3 gb
Page 71
8
Fig.: 8 - 2
Procedural Instructions on the TSC
Functional InspectionSwitch 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
-Display on the LC display
All symbols and display pixels flash for a short moment
Fig.: 8 - 2. Then „000.0ml/h“ is displayed
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
and bottom.
4. Carry out infusion with intermediate bolus and press all buttons 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.
Infusomat® fmS 2.3 gb 8 - 3
Page 72
Procedural Instructions on the TSC
8
Note
Fig.: 8 - 3
1
2
10 ml air
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.
If a mechanic manometer is used instead values which are approx.
100 mbar lower are to be expected. Proceed as follows:
The liquid level in the container must be approx. 80 cm above the
lower edge of the device.
-Original Infusomat® Line
(new, can be used for the complete TSC incl. functional check)
(1 piece)
or
-Infusomat® Space Line
(new, can be used for the complete TSC incl. functional check)
(1 piece)
-Infusion bag or bottle, min. 500 ml
(1 piece)
-Three-way valve
(2 pieces for measurement with electronic manometer)
-10 ml syringe (air buffer for measurement with electronic
manometer)
(syringe drawn up with air to 10 ml and piston fixed mechanically)
(1 piece)
-1 ml syringe for air bubble injection
(1 piece)
-Electronic manometer with peak value recognition
(1 piece)
-Pressure cell (option of electronic manometer)
Diameter 100 mm / 160 mm, measuring range 2.5 bar / 4 bar
(1 piece)
-Graduated cylinder 25 ml, +/- 0.4 ml
(1 piece)
8 - 4 Infusomat® fmS 2.3 gb
Page 73
8
Fig.: 8 - 4
1
2
Fig.: 8 - 5
1
2
Procedural Instructions on the TSC
Pressure Cut-Off, Electronic
The MFC service connector must not be plugged.
The drop sensor must not be connected.
1. Insert the line of the test setup in the device.
2. Enter a delivery rate according to the TSC.
3. Select pressure stage according to the TSC.
4. Vent test setup, position of the three-way cocks please see
Fig.: 8 - 4.
5. Start infusion and deliver first of all in to an open system
(without manometer).
6. Switch over three-way cocks, please see Fig.: 8 - 5, and deliver against the manometer.
Read off maximum value on the pressure gauge upon an
alarm and before an automatic pressure reduction and com
pare with the specifications in the TSC.
7. Check all pressure stages listed in the TSC and document values.
Pressure Limitation, Mechanical
The drop sensor must not be connected.
1. Plug MFC service connector on the MFC plug connector.
2. Activate the occlusion pressure mechanical (see „Disabling
the Pressure Sensor (Occlusion Pressure Mechanical)“ ➪
p. 3 - 2).
3. Enter a delivery rate according to the TSC.
4. Start infusion and deliver first of all in to an open system
(without manometer).
5. Deliver against the manometer.
Read off the corresponding value on the manometer and
compare with the specifications of the TSC for P
6. Document values. Do not reduce pressure.
max
and P
min
-
.
Safety Clamp (Flow Inhibitor)
1. Stop infusion from the pressure limitation test mechanically
and unlock the operating unit,
read off value on the manometer and compare with the specifications in the TSC.
Infusomat® fmS 2.3 gb 8 - 5
Page 74
Procedural Instructions on the TSC
8
WARNING
Fig.: 8 - 6
25 ml ± 0.4 ml
Reference height
80 ± 2 cm
2. Document value.
3. Pull off the MFC service connector.
SWITCH THE DEVICE OFF AFTER THE SAFETY CLAMP WAS
CHECKED SO THAT THE ELECTRONIC PRESSURE CONTROL IS RE
ACTIVATED AFTER A RESTART.
4. Switch device off.
Delivery Accuracy
Requirements:
-Mount test setup as shown in Fig.: 8 - 6.
-Ambient temperature and delivery rate according to the TSC.
1. Insert line of the test setup in the device.
2. Vent test setup. Bottom part of drop chamber must be 2/3
filled.
3. Insert cannula in empty graduated cylinder.
4. Set delivery rate according to the TSC.
-
5. Simultaneously start infusion and stop watch.
6. Stop the stop watch when the measured volume defined in
the TSC is reached.
7. Evaluate deviation in percent according to Table 8 - 1 and
record.
Measuring TimeDeviation
%
6 min 40.0 sec -10
6 min 18.9 sec-5
6 min 15.0 sec-4
6 min 11.1 sec-3
6 min 7.3 sec-2
6 min 3.6 sec-1
6 min 0.0 sec0
5 min 56.4 sec1
5 min 52.9 sec2
5 min 49.5 sec3
5 min 46.2 sec4
5 min 42.9 sec5
5 min 27.3 sec10
Table 8 - 1
8 - 6 Infusomat® fmS 2.3 gb
Page 75
8
Procedural Instructions on the TSC
The accuracy of the delivery rate can be checked using a normal
infusion line when the TSC is carried out.
A test infusion line (OIL test infusion line with an Infusomat® fmS
adjusted for the Original Infusomat® line, and a Space calibration
line with an Infusomat® fmS set for the Infusomat® Space Line) is
to be used for calibration
p. 3 - 9)! (see „Test Equipment and Special Tools“ ➪ p. 9 - 1).
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.
(see „Scale Factor Function 510.0“ ➪
Air Inline Sensor
1. Plug MFC service connector on the MFC plug connector.
2. Insert a line filled with water in the device and close operating unit.
3. Read off test value of the air inline sensor via the function
300.0 “Air inline sensor” in the Service Program
line Sensor Function 300.0“ ➪ p. 3 - 5).
4. Read off value after approximately 10 seconds and compare
with the water value specifications of the TSC.
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
line Sensor Function 300.0“ ➪ p. 3 - 5).
11. Read off value after approximately 10 seconds and compare
with the air value specifications of the TSC.
(see „Air In-
(see „Air In-
-
12. Read off threshold value via the function 520.0 “Air inline
sensor” in the Service Program
tion 520.0“ ➪ p. 3 - 10).
Infusomat® fmS 2.3 gb 8 - 7
(see „Air Inline Sensor Func-
Page 76
Procedural Instructions on the TSC
8
13. Compare value with the threshold value specifications of the
TSC.
Battery Check
1. Disconnect the device from the mains supply during operation.
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.
8 - 8 Infusomat® fmS 2.3 gb
Page 77
9
9 - 2
9 - Test Equipment and Special Tools
For Repair / for TSC
Order No.
Test equipment case Infusomat fm (complete) . . . . . 0770 1527
with:
Calibration gauge 4 mm (for adjustment after exchange