Important Information on this ManualService Work Page 0 - 5
Technical Safety Inspections Page 0 - 5
Current Versions Page 0 - 5
Revision Service Page 0 - 5
Non-Liability Page 0 - 5
ISO 9000 ff/EN 46 000 ff Page 0 - 6
Repair and Inspection only
by Trained Technicians Page 0 - 6
Spare Parts and Test Equipment Page 0 - 6
Setting Off Page 0 - 6
General InformationTechnical Training Page 0 - 7
Entry for the Product Training Page 0 - 7
Ordering of Spare Parts and Test Equipment Page 0 - 7
Return of Spare Parts Page 0 - 7
Service Hotline Page 0 - 7
Safety Officer Page 0 - 7
Translation Page 0 - 7
Service ProgramStructure of the Service Program Page 3 - 1
Additional Functions with
Inserted Service Plug Page 3 - 2
Start / Quit the Service Program Page 3 - 3
Unit Data Page 3 - 3
History Data Page 3 - 5
Test Page 3 - 6
Unit Modifications Page 3 - 7
Calibration Page 3 - 10
Workstation Page A - 1
Revision Service-Documentation Page A - 2
Current Information Page A - 2
Order Form Page A - 2
0 - 4 Infusomat P 2.0gb
0-Important Information on this Manual
The following notes should be observed:
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
-fulfil the personal requirements (training and knowledge).
Technical Safety InspectionsB. Braun also recommends training on the technical safety in-
spections, or to perform at least the steps indicated in the current
version of the manual, as:
-the TSI requires that the instructions in the manuals are observed
-the manuals are a reference for measurements
-depending on the unit type, the service program must be
called up which may lead to a dangerous unit condition in the
case of an inappropriate operation. Furthermore, a special
service connector may be necessary.
0
Current VersionsThis manual version corresponds to the state when the manual
was written. Technical changes, especially software modifications
must always be expected. The state of the revision is indicated by
the index number on the title 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
(incurred costs).
Non-LiabilityB. Braun Melsungen AG does not assume any responsibility for in-
juries to persons, property damages or other damages caused by:
-the use of a wrong manual, or a manual which does not correspond to the revision state for maintenance, repair, and
service tasks
-the non-inclusion of the service technician in the revision
service
-technicians who have not participated in a technical training
course for the specific B. Braun unit.
Infusomat P 2.0gb 0- 5
0
ISO 9000 ff/EN 46 000 ffB. Braun is certified in accordance with DIN ISO 9001 and DIN EN
Repair and Inspection only
by Trained Technicians
Spare Parts and Test EquipmentOnly use original spare parts from the manufacturer. Do not
Important Information on this Manual
46 001. This certification also includes maintenance and service.
The Infusomat P complies with the IEC/EN60601-1 and
IEC/EN60601-2-24 standards and is certified with the CE label according to the EC directive 93/42/EC.
Training may only be performed by B. Braun. The possession of the
manual does not authorize the performance of repairs. The instructions on electrostatic sensitive components (ESD standards)
must be observed.
An electrical check must be performed following each repair (see
„Checks after Repair“ ➨ pg. 5 - 1).
tamper with assembly groups which can only be exchanged completely. The spare parts required are listed in the repair instructions.
The inspection personnel is responsible for the calibration of the
test equipment. Original test equipment can be calibrated at the
works of B. Braun. Further information is available upon request.
Setting OffAdditional notes and warnings are set off as follows:
Note
Gives additional or special notes on 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.
0- 6 Infusomat P 2.0gb
0 - 8
0-General Information
Technical TrainingB. Braun Melsungen AG
Stadtwald Haus 6
D-34 212 Melsungen
Germany
Responsibility
Dieter GundlachTel.:+49 5661 71 - 37 74
Fax:+49 5661 71 - 28 81
Entry for the Product TrainingOnly via the responsible representative
Ordering of Spare Parts and Test EquipmentB. Braun Melsungen AG
P.O. Box 11 20
D-34209 Melsungen
Germany
0
Hospitals and SuppliersTel.:+49 800 2 27 28 24
of HospitalsFax:+49 5661 71 37 98
Dealer and Tel.:+49 5661 71 36 28/29
Medical HousesFax:+49 5661 71 35 50
Return of Spare PartsB. Braun Melsungen AG
Schwarzenberger Weg 73-79
Wareneingang Werk C
D-34 212 Melsungen
Germany
Service HotlineMr. Tippel, Mr. Clobes
Tel.: +49 56 61 71 - 35 25
Fax: +49 56 61 71 - 35 26
E-Mail: karl.tippel@bbraun.com
E-Mail: christian.clobes@bbraun.com
Safety OfficerDr. Wilhelm Wucherpfennig
Fax: +49 56 61 71 - 46 36
E-Mail: wilhelm.wucherpfennig@bbraun.com
TranslationBrückner GmbH, Germany
Infusomat P 2.0gb 0- 7
0
For your notes:
General Information
0- 8 Infusomat P 2.0gb
1 - 10
1-System Overview
DesignThe Infusomat P 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 keypad. It is equipped with
an LCD (liquid crystal display) for the display of the delivery rate
and the operating support of the user. Two control LEDs display
alarms, and the running of the infusion pump.
1
Handle
Door Lock
LCD Display
Softkeys
Keypad
Barcode Label
Control LEDs
Guide for Short Pole Clamp
Mains Connection
Optical
Interface
fm Recessed Plug
Potential Equalization
Bolt
Drop Sensor Socket
Drop Sensor
Flow Inhibitor
MFC-Socket
Peristaltic Pump
Air Sensor
IP 003
Fig.: 1 - 1 Unit Design Infusomat P
A barcode label is attached to the left front side of new Infusomat
P 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 P is operated in an fm-system.
Infusomat P 2.0gb 1- 1
1
Operation Flow Chart
System Overview
Standard Operation
Switch On
Tube Selection
Service Plug,
Inserted ...
1
5
Special Functions ...
3
Set Delivery RatePreselected VolumePreselected Time
Rate Calculation
Start Infusion
Stop Infusion
Change Delivery Rate
Recall Info
Call up Bolus
KOR Mode
2
1
See service program diagram
2
Only when preselected time or preselected volume has expired
3
Please pay attention to the activation in service program
4
Only available with IFPC
5
From software IFPe, IFPE
6
From software IFPE
-Dose Calculation
-Bolus Function
-Standby Function
-Drug Change
-CC Mode
-Occlusion Pressure
-Drop Control
-Piggyback
-Battery Capacity
-Data Lock
-Alarm Tone
-Contrast Setting
-Clock
4
5
6
5
5
Fig.: 1 - 2
See Instructions for Use for detailed information.
1- 2 Infusomat P 2.0gb
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 processor. Both systems work with independent clock frequencies and
have access to different program and data memories. All safetyrelevant functions are handled by both processors and the results
are counter checked (CF- and FC-latch).
The input via the keypad 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 processor has
also access to this logic via E/A-INT.
Description of the voltage signals (see „Signal Table“ ➨
pg. 1 - 5).
1
Fig.: 1 - 3
Infusomat P 2.0gb 1- 3
1
Voltage SupplyThe voltage supply is generated either directly from mains, via the
System Overview
FM plug (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 plug. The FET V10 switches between the external and
the internal voltage supply. The transistor V10b works as an ON/
OFF switch for the operating voltages UBS, 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 UBS 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 transistor 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 drive 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-holding pulses fed to the logic. The alarm latch is also activated.
1- 4 Infusomat P 2.0gb
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
System Overview
MOTEINMotor ONTSRDrop Sensor Regulation
MSMotor ControlTSSDrop Sensor Control
P-ENAPort EnableTxTransmit Data
PH0Phase 0UBA, UBBSupply Voltage for Alarm, On/Off Logic, RTC
PH1Phase 1UBSSwitched Operating Voltage UB
PH2Phase 2UBS-MUBS 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 the
charging, the voltage supply is maintained. In this case only a battery balance is carried out, because a key was not pressed. The actual 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 Infusomat P is switched off in mains operation with the ON/
OFF key, the internal mains voltage is still present.
In mains operation the battery function is checked during the
switch-on test. Therefor the charge and discharge current is
1- 6 Infusomat P 2.0gb
System Overview
measured and the charging of the battery is interrupted for the
duration of the 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 the
switch-on test. The theoretical load condition is read from the
clock module of the battery. Then the battery is connected to UBS
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)
1
-Audible alarm due to the drive of the buzzer or the loudspeaker via ALA-AK (control channel) or via ALA-UB
-Optical alarm. Is displayed in the LCD and a separate LED display. 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 P, e.g. open pump cover during operation.
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 pluse-free flow is realized in the lower delivery range (<100 ml/h). The total pump head cycles and running
time are available in the service program under history data.
Infusomat P 2.0gb 1- 7
1
System Overview
Mechanical Occlusion Pressure:
The Infusomat P 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 cover 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 mechanically 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 deflection 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 P is equipped with a computer interface. It can be
connected to the optical interface or via the MFC service plug. To
activate the computer operation please ask for a detailed description from B. Braun.
Until software version IFPC: DIANET
From software version IFPe, IFPE Dianet
1- 8 Infusomat P 2.0gb
Star
System Overview
Braun fluid manager system (fm system)The Infusomat P can be operated as a stand-alone unit or inte-
grated 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
Fig.: 1 - 5
Infusomat P 2.0gb 1- 9
1
AccessoriesGeneral
System Overview
DesignationOrd. No.
Mounting clip for drop chamber ”TK 2000” . . . . . . . . 3477 3223
Mounting clip for drop chamber ”Intrafix P” . . . . . . . 3477 3215
The higher digit always replaces the lower digit for the revision
level, e.g. IFPE13003 replaces IFPE13002.
When the software group changes (IFPE13002) the unit functions
Position123456789
DigitI FPE13003
are changed, too. Therefore unit users must be informed (e.g. instruct the user and exchange the instructions for use – software
coding, e.g. IFPE is on the cover page of the instructions for use.)
2
Infusomat P
Fig.: 2 - 1 Coding
Revision Level
Hardware Identification
Software Group
Note
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 IFPC02002 to IFPC02001!).
All units used in one ward should have the same software status
and basic setup to avoid operator mistakes.
Note
Software updates must be reported to B. Braun for registration.
Observe the notes of the update program and the supplements!
Infusomat P 2.0gb 2- 1
2
Approved Software VersionsIFPC02001
Software
-Basic software
(Must not be used any more. Please contact the Technical
Service of B. Braun).
IFPC02002
-No optical staff call after power up (fluid manager system)
-Optimized air sensor evaluation
-Manual bolus volume limited to 99.9 ml
-Optimized special bolus function
IFPe02003
-Preselected volume and time counted down to 0
-Long-time compensation of delivery rate
-Interface changed to DIANET
(not compatible with Dianet)
-New special function Piggyback
Star
-New special function clock
-Storage of alarms in case of malfunctions, which can be recalled in the service program menu 230
-Tube selection menu
-Calibration occlusion sensor
-Tube update
IFPE13002
Only controller board with loudspeaker (see „Controller Board“
➨ pg. 4 - 6).
-Alarm volume can be set
-History function
IFPE13003
-Optimized dose calculation
2- 2 Infusomat P 2.0gb
Error Messages and Alarms
7 Segment Display
Fig.: 2 - 2
Text Field
Software
Alarms of the function processor 80c535 are displayed in the text
field of the LCD. Alarms of the control processor 68HC11 are displayed in the 7 segment display. The alarms help to troubleshoot
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 field as ”Unit
Alarms” in the selected language. Additionally the error number is
displayed in the text field.
2
Text FieldDescription
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 keypad 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 program memory transit time ROM-test
120defective program memory tube parameters
Table 2 - 1
Infusomat P 2.0gb 2- 3
2
7 Segment Display Description
FF01dummy for test
FF02battery not present / missing battery current
FF03defective RAM memory
FF04defective program memory - ROM test error 1
FF05defective program memory - ROM test error 2
FF06calibration data error from EEPROM
FF07pump head cycle not plausible
FF08failure / inaccuracy of system clock
FF09failure 100msec system clock
FF10reset during active operation
Software
Control Microprocessor 68hc11
FFxx is displayed in the 7 segment display with flashing dots. FFxx
is the error code.