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1. Trainer guideline Infusomat fmS
incl. Infusomat P and Infusomat fm
Permitted to use by technical Trainers only
Version 1.3_gb
2. Used documents Preparation
• Instructions for use Software IFME/IFMe
• Service Manual Version: 2.1 English
2
3. Used abbreviations
• TGL = Trainer guideline
• IFU = Instructions for use
• PT = Participant
• mpl = motor power limitation
• Tx = Torx x-size screwdriver
• MSC = Multi Socket Connector
• CAN = Controlled Area Network
• RTC = Real Time Clock
• SM = Service Manual
• TSC = Technical Safety Check
• PPT = Power Point
• HiBaSeD = History, Barcode, Service, Drug list
• PCB = Printed Circuit Board
• KVO = keep vein open
3
4. Overview Seminar workflow
• „Preparation“
• „Introduction“
• B. Braun Presentation
• Quality assurance
• General Info‘s/risks of CI
• System Overview
• Service manual
• Disassembly
• Assembly
• Service program and calibration
• Checking
• Current changing
• Documentation and certifying
4
5. 1.3 Checklist Special-/Calib. tools Preparation
Disassembly/Assembly
• Cross tip screwdriver Pozidrive Gr.0
• Cross tip screwdriver Pozidrive Gr.1
• Cross tip screwdriver Pozidrive Gr.2
• Slot head screwdriver small
• Screwdriver Torx 10
• Tweezers (with special coating)
• ESD Kit
• Wrist line
• Box spanner 7 mm and 10 mm
• Allen key 2,5 mm, 3 mm
• Plastic hammer
5
6. 1.3 Checklist Spezial-/Calib. tools Preparation
Disposables
• Tubing systems 1x Original Infusomat Line
1x Intrafix Air P
• Others 1x Injekt Syringe 1 ml
1x Discofix 3 stopcock
6
7. 1.3 Checklist Spezial-/Calib. tools Preparation
Calibration, Checking, Others
• (MFC) Interface line 8711661 only for Software updating
• Service plug (MFC) 34501215
• 4mm gauge 7701527
• Pressure adjustment device 7705018
• Pin punch 1,8mm 7701446
• Pin Punch 6 mm 7701454
• (Flat tool) 7701462
• Special socket spanner M 18 7701497
• Manometer 0 -4 bar 7701357
• OIL test infusion line 7701500
Test equipment case Inf. fm (complete) 7701527
Electrical safety tester
7
8. 6. System Overview
6.1 The view
6.2 Dimensions
6.3 Device and accessory
6.4 The Infusomat fmS
6.5 Powering on and handling
6.6 Start of Infusion
6.7 Additional settings
6.8 Special functions
6.9 Settings inside Service program
6.10 Alarms
6.11 Software versions
8
10. 6.2 Dimensions System overview
H = 240 mm
weight: app. 3,1 kg
m
0m
20
T=
B =140 mm 10
11. 6.3 Device and accessories System overview
Including in delivery:
• Device
• Mains cable
• Drip sensor
• Instruction for use
• Pole clamp
• Final inspection certificate and current TSC checklist
11
12. 6.3 Device and attachment System overview
Universal clamp
(Pole Clamp)
Developed for fixing stand
alone pumps to infusions-
poles and wall rail systems.
3 different versions available
I.f.u. Pole Clamp Rotation mechanism
for horizontal and
vertical adaptation of
the pumps
12
13. 6.3 Device and accessories System overview
Integrated power supply
•Mains voltage: 230V ~/50-60 Hz/0,06A or
100V/110V/120V ~/50/60 Hz/0,12A
•Voltage: 12V DC/1A
•Insulated construction
13
14. 6.3 Device and accessories System overview
Drip sensor
Short stand with
holder for Drip
chamber
(optional)
14
15. 6.3 Device and assessories System overview
The drip sensor
•Drip chamber Adapter replaceable
depending on drip chamber size
•Infrared light pulse with about
1 A current
•Pulse frequency 1000 Hz
•Wide angle optic
•Shielding for a better EMC
protection (see production stamp)
15
16. 6.3 Device and accessories System overview
Light pulses
10µs
1ms
1,0 A
Receiving window
Frequency = 1kHz
16
17. 6.3 Device and accessories System overview
Original Infusion line
• Is going to be replaced by
Space Line (DC 2000)
• 2 filter inside tubing system.
Bacteria leak proof venting
filter, 15 µm particle filter
inside the drip chamber
• Diverse type see IFU page 19
• 20 drops equals approx. 1 ml
17
18. 6.4 The Infusomat® fmS System overview
6.4.1 Back
6.4.2 Bottom side
6.4.3 The Front
6.4.4 The upper housing
18
19. 6.4.1 The back The Infusomat® fmS
Service seal
Holder for short stand and
cable guiding for drip sensor
Drip sensor connector
Mains connector with
T 0,16 A fuse
Potential equalization
bolt
19
20. 6.4.1 The back Der Infusomat® fmS
Adaptation for Pole clamp
MFC connector
(12V, staff call, PC,
Fm system 2. generation)
Infrared interface
(FM system 1. generation)
12 V connector stabilized
(FM system 1. generation)
20
21. 6.4.1 The back The Infusomat® fmS
MFC =Multi Functions Connector
21
23. 6.4.2 The Bottom side The Infusomat® fmS
Unit feed with
rubber elements
Battery
cover
23
24. 6.4.2 The Bottom side The Infusomat® fmS
Battery
compartment
with NiCd Battery
7,2V 1,2Ah.
delivered incl.
cover.
24
25. 6.4.3 The Front (closed) The Infusomat® fmS
Handle
Door opener
LCD Display
Key pad
Alarm- and operating
indicator LED
25
26. 6.4.3 The Front (key pad) The Infusomat® fmS
Soft keys
On/off key
Numeric
key pad
Alarm ton
mute key (2 min)
Start/Stop
Clear key
Alarm LED
Operating LED Decimal key
26
27. 6.4.3 The Front (inside) The Infusomat® fmS
Handle with upper Peristaltic pump unit with
tube fixation membrane
Upper line fixation Counter piece
for Space line pump door locking
Pump door
Door locking unit Door locking bolts
Anti Freeflow-
clamp Pressure sensor
Lower tube fixation
Ultrasonic air detector
27
28. 6.4.3 The Front (inside) The Infusomat® fmS
Anti Freeflow clamp
28
29. 6.4.3 The Front (inside) The Infusomat® fmS
Ultrasonic Airsensor
Technical sensitivity: Air bubble detection > 0,01 ml
Single bubble: 0,01 – 0,3 ml default 0,3 ml
Amount of air: 0,5 – 3,5 ml/h cumulated default 1,5 ml
29
30. Air Alarm
Single Bubble Alarm Air Rate Alarm
(1 h range)
Alarm value 1.5 ml (var. 0.5-3.5 ml)
(Standard)
Alarm value 0.3 ml (var. 0.01-0,3 ml)
(Standard)
next page
30
31. Air Sensor Value Infusomat fm
494 mV
Water Value
Only use the current
Values from the TSI
182 mV List!!
Alarm Value
91 mV
Air Value
Tube Bubble
next page
31
32. Air Sensor Value Infusomat fm S
481 mV
Water Value
Only use the current
Values from the TSI
182 mV List!!
Alarm Value
78 mV
Air Value
Tube Bubble
next page
32
33. Air Sensor Value Infusomat P/ Vista
455 mV
Water Value
Only use the current
Values from the TSI
130 mV List!!
Alarm Value
65 mV
Air Value
Tube Bubble
next page
33
34. Infusomat fm/S/P – Air Trap Signal
Transmitter
39 V
1 µs
Receiver
Alarm
Threshold
5 µs
20 µs
next page
34
35. Infusomat fm/S/P – Test Value
Transmitter
Receiver Alarm Threshold
Measuring Test Value Measuring Test Value
Value Value
35
36. 6.4.4 The upper housing The Infusomat® fmS
Handle
Short instruction
36
37. 6.5 Powering on and handling System overview
Display when tapping On/Off key for a short time
without mains connection
•Display light dimmed
•Software version
•Current battery capacity
•Ward identification (when used)
•Date/time flashing (from Software IFM E)
•## = History- Function (from Software IFME)
•Mains connection symbol:
•Battery symbol
•Service mode Symbol (with Service plug): flashing
37
38. 6.5 Powering on and handling System overview
Display with mains connection and switched off
• Akku Symbol (in Abhängigkeit):
• Mains connection symbol:
• Service mode Symbol (with Service plug): flashing
• Operating time
• Battery capacity
• Software version
• ## = History- Function (from Software IFM E)
38
39. 6.5 Powering on and handling System overview
Displayed things without with
mains mains/off
Display light dimmed yes yes
Battery symbol yes depends
Mains connection symbol: no yes
Date/time (from Software IFM E) yes yes
## = History- Function (from Software IFM E) yes yes
Ward identification (when used) yes yes
Current battery capacity yes yes
Operating time yes yes
or [ Software version
Service mode Symbol (with Service plug): flashing
yes
yes
yes
yes
39
40. 6.5 Powering on and handling System overview
After switching device on the following self test must be correctly
passed through:
Optical Acoustic
000,0 beep beep beep
888,8 and display of all symbols and LEDs
000,0
40
41. 6.6 Start of Infusion System overview
• Prepare infusion system and prime
• Insert Infusomat line according IFU and close door
• Open roller clamp (no free flow should occur)
• Place drip sensor at drip chamber
• Set delivery rate
• Start Infusion by pressing Start/Stop key
41
50. 6.8 Special functions System overview
Special functions can be activated or deactivated in service
program.
All special functions are available when the service plug is
connected.
50
51. 6.8 Special function System overview
6.8.1 Bolus function
6.8.2 Standby / Pause
6.8.3 Drug display
6.8.4 Occlusion pressure
6.8.5 Switch off drip control
6.8.6 Check battery capacity
6.8.7 Data lock
6.8.8 Loudness control
6.8.9 Contrast
6.8.10 Date / Time
6.8.11 Dosage calculation
6.8.12 Piggyback
6.8.13 History
6.8.14 Double rate entry
51
52. 6.8.1 Bolus function Special functions
Bolus function is available as follows:
•Bolus with volume pre-selection
•Bolus without volume pre-selection (on demand)
•Interval bolus
All bolus functions are also available in dosage
calculation mode.
52
63. 6.8.8 Loudness control Special functions
This function is only available in devices with
the Software version IFM E xxxxx.
63
64. 6.8.9 Contrast Special functions
Inside this function there is the opportunity to adapt
the contrast of the display via „-“ or „+“ key to the
optimal readability!
64
65. 6.8.10 Set Date/time Special functions
Date and time setting is only be used in correlation with the
History-Function
65
66. 6.8.11 Dosage calculation Special functions
Please find a complete
information about dosage
calculation on page 10 – 11
in the Instructions for use.
Dosage calculation is a
comfortable arithmetic
operation, which helps the
user to calculate a delivery
rate form different
parameters (rule of three)
66
67. 6.8.12 Piggyback Special functions
A complete information about the Piggyback-Function
see IFU page 12
67
68. 6.8.13 History Special functions
History Function
In connection with the software „IFME“ the Infusomat fmS
is equipped with a history function (memory of events). This
permanent memory records the last 350 events time- and
date related:
- Set delivery rate
- Changes of the rate
- Switching on/off
- Start/Stop of infusion
- Remote Control
- Operating and device alarms
Protocol display (see IFU page 8) via terminal program
68
69. 6.8.14 Double Rate entry Additional settings
• The function double entry is a safety function. It is intended to
minimize the danger of entry error:
• A delivery rate must be typed in twice in order to really set it.
Only when the entries are identical it will be possible to start
the infusion.
69
70. 6.9 Settings inside Service program System overview
Overview (Details later on during practice session)
Settings as follows can be set in service mode only
(see also SM starting page 3-6):
- Max. delivery rate
- Air alarm
- Staff call
- Alarm ton
- Dianet address
- Activate and deactivate of special functions
- User- and Service language
70
71. 6.10 Alarms system overview
6.10.1 Operating alarms
Operating alarms can be mute for 2 minutes. When the user
remedy the failure, a restart of the therapy is possible!
6.10.2 Device alarms
Device alarms can‘t be mute. An audible alarm sounds
permanently. Infusion will be stopped (patient safe state).
71
72. 6.10.1 Operating alarms System overview
Following alarms (IFU Page 13) will be displayed as text together with
an optical and audible signal:
•Drip alarm
•Pressure alarm
•Air alarm
•End of Standby time
•Battery pre alarm (30 min) -> battery end alarm
•KOR Alarm
•Pump door open
•Invalid rate
•Reminder alarm
72
73. 6.10.1 Alarm (pressure alarm) System overview
Pressure inside the infusion system will be measured by a
mechanical pressure sensor system. This system moves a metal core
inside a coil. Graphic pressure alarm principle
A change in inductivity will create an electronic signal which will
be changed in a digital information. During calibration of the
pressure sensor limiting values will be measured and stored.
In infusion mode there is a continuous monitoring and comparison
of rated value and current value. In case of deviation pressure
alarm will be given.
73
74. 6.10.2 Device alarms System overview
Device alarms can‘t be mute. An audible alarm sounds permanently.
Infusion will be stopped (patient safe state).
„Device alarm“ will be displayed in the LCD display. A numeric error code
will also be displayed.
The error code of the Function processor 80c535 will be displayed in the
upper area of the display (7-Segment-Display).
The error code of the Control processor 68HC11 will be displayed in the
lower area of the displays (text area).
For an efficient troubleshooting you need both error codes!
(SM page 2-3ff)
74
75. 6.11 Software Versions System overview
Supplied and released software versions
Infusomat fmS:
Version Art. from SN Date Kind of Modification
IFM C 02002 5177 17.11.1998 -
IFM C 02003 22756 05.05.2000 -
IFM E 03002 3450645B 34298 19.04.2001 New Hardware/Dianet Star
IFM e 02002
IFM E 03004 3450645C 41923 27.11.2001 Dianet Star, changed dose
IFM e 02004 calculation
IFM E 03005 3450645D 63136 01.07.2003 Dianet Star
IFM e 02005 cyclic battery test
IFM E 03006 3450645E 69846 12.02.2004 Dianet Star, Cut down
IFM e 02006 sequence optimized
75
76. 6.11 Software Versions System overview
Supplied and released software versions
Infusomat fm:
Version from SN Date Kind of Modification
(approx.)
IFM A 00002 1559 01.03.1993 -
IFM A 00003 5379 04.01.1994 -
IFM B 00001 25176 19.03.1996 Self test, run control
IFM B 00002 45446 04.02.1998 Dianet Star
76
77. 6.11 Software Versions System overview
Supplied and released software versions
Infusomat P:
Version Art. from SN Date Kind of Modification
IFP C 02001 1 blocked
IFP C 02002 695 07.12.1998
IFP E 13001 5506 05.05.2000 New Hardware/Dianet Star
changing max. delivery rate to
IFP E 13002 3450645B 5704 999,9 ml/h, Hardw. changing
IFP e 02002
IFP E 13003 3450646C 7217 22.01.2002
IFP e 02003
IFP E 13004 3450646D 23844 09.08.2004 Changing of battery test
IFP e 02004
77
78. 7. Service Manual
7.1 Overview
7.2 How to handle
7.3 Change control
78
79. 7.1 Overview Service Manual
Chapter Content
0 Important information on this manual, general info
1 System overview
2 Software
3 Service program
4 Unit elements
5 Checks after repair
6 Maintenance
7 Technical safety check (TSC)
8 Procedural Instructions for inspection
9 Test equipment and special tools
10 Spare parts list
A Appendix
79
80. 7.2 How to handle Service Manual
Please find spare part numbers in chapter 4 „unit elements“
together with the corresponding repair instruction.
Please find also the complete spare parts list in chapter 10.
The checklist „Checks after repair“ is separated in 4 parts (see
chapter 5).
Depending on the work carried out, the relevant check blocks have
to be used.
80
81. 7.3 Change control Service Manual
A database is in schedule to realize change control and technical
information in the future.
Trained technicians will receive access to this database.
Technical information will become available for download.
81
83. 8.2 The procedure (overview) Disassembly
Disassembly lesson is separated into steps as follows:
(Service on closed device open the housing elements inside)
8.2.1 Demo/part A
- Opening the housing
- Disassembly of Controller board
- Disassembly of back incl. power supply, MFC and other
connectors
8.2.2 Demo/part B
- Disassembly of Front
- Disassembly of the pump unit
- Disassembly of door unit
83
84. 8.2.1 Demo/Part A Disassembly
Opening of housing
• Disassembly of battery
• Loosing of 4 screws and one screw at the back.
Spread housing at the lower end a little to remove it
Disassembly of Controller board
• Loosen connectors to the PCB
(attention: zero force connector!!)
Compatibility-Table (SM page 4-5 ff)
• Loosen plastic punch clip
84
85. 8.2.1 Demo/Part B Disassembly
Disassembly of the Front
• Spreader
• Air sensor, Reed sensor
• Front panel (complete exchange is recommended)
Disassembly of pump unit
• Disassembly of pump motor always before pump unit!!
• Pressure sensor disassembly (caution of screw)
Disassembly of door unit
• Door lock
• Rubber cable pre formed (position and connector)
• Operating unit (LCD, etc.)
• Hinge pin
85
93. 9.1.4 Pressure sensor and pump unit Caution
After exchange of pressure sensor unit a calibration is obligatory.
When exchanging the pump unit all user specific settings are lost.
• With a new pump unit all user specific settings has to be entered again
(see SM 4-12ff)..
• Before removing the pump unit always remove the motor.
• Mount pressure sensor PCB not with pre stressing of pressure sensor
Basic setting of pressure sensor PCB has always to be carried out.
93
94. 9.1.4 Pressure sensor and pump unit Caution
Adjusting screw for
mechanical pressure
cut off
Never loosen this
screw !!
94
95. 9.1.4 Pressure sensor and pump unit Caution
Adjustment screw for basic
setting of pressure sensor by
using the 4mm template.
95
96. 9.2 Typical Fault(s) Caution
• It is impossible to turn on device.
Reason: Rubber flex cable Front -> Controller board
• etc.
96
97. 10. Service Program and Calibration
10.1 General
10.2 With service plug
10.3 Service Program
(structure, opportunities)
10.4 Preparing calibration
97
98. 10.1 General Service Prog./Calib.
• The service program is part of the device software
• Interface to the service program is the keypad of the pump
• Service program is only available when using the service plug
(last point in special functions).
• All calibration and changes will become effective after data
backup
98
99. 10.2 With service plug Service Prog./Calib.
Expanded functions with plugged in service
Plug:
• Display **
• Acoustic alarm is inactive
• Operating alarms are mute
• Additional display of the battery capacity (0Min/32Min)
• Target/actual comparison display alternating
• Pressure state mechanical is accessible
• The service program is accessible
• Expanded alarm display
With plugged in service plug it‘s forbidden to run the device at the
patient!
99
100. 10.3 Service Program Service Prog./Calib.
Structure of service program is described in service manual.
(see chapter 3-1 ff.)
The Service program consists of the following groups:
• Group 100 Unit data
• Group 200 History data
• Group 300 Test
• Group 400 Unit modification
• Group 500 Calibration
100
101. 10.3 Service Programm Service Prog./Calib.
Demo with exercise of the service program
• Fct 300 Air sensor test – air-/water value
Fct 520 Air sensor – value entry (182 mV)
• Fct 310 pressure sensor – here only valuation
(„basic setting“ + adjustment off pressure sensor SM 4-13)
Fct 540 Occlusion level – value entry!
101
102. 10.3 Service Programm Service Prog./Calib.
Demo with exercise of the service program
Fct 310 Pressure sensor – two different adjustment devices are
available:
a. for Inf. fm and fmS and
b. for Inf. P (also valid for Inf. fm + Inf. fmS)
102
103. 10.3 Service Programm Service Prog./Calib.
Main settings that only can be modified inside the service program:
- Alarm tone (Fct 420)
- Staff call (Fct 430)
- Activating/deactivating of special functions (Fct 440)
- Availability of menu on user interface (Fct 450)
(double rate entry, Online rate entry, Interval bolus)
- Max. delivery rate (Fct 460)
- Alarm threshold for air alarm (Fct 470)
- Operating alarms can be displayed (Fct 230)
103
104. 10.4 Preparing Calibration Service Prog./Calib.
• Performing of calibration (SM – page 3-9, and 4-12ff)
• To perform a calibration of the delivery rate a special calibration
line has to be used
• For the calibration of the pressure sensor it is a must to use the
pressure adjustment device
104
105. 11. Checking
11.1 Checking after repair
11.2 Preparing the TSC
11.3 Maintenance
105
106. 11.1 Checking after repair Checking
• See Service Manual chapter 5
• The checklist „Checks after repair“ is separated into 4 parts.
Depending on the work carried out, the relevant check parts have
to be performed.
106
107. 11.2 Preparing the TSI Checking
• Be aware of the checklist TSI chapter 7 and the „Procedural
Instructions for Inspection“ chapter 8 inside service manual.
• The delivery accuracy check is carried out with a measure cylinder
or a weight measurement (scale).
• The occlusion pressure check is carried out with a manomenter or an
electronically measuring system.
• The respectively valid calibration value for the air detector out of
the TSI form has to be set at the device/-type.
(Infusomat fm/fmS at present = 182 mV)
107
108. 11.3 Maintenance Checking
Maintenance is recommended every 2 years.
Please find a list with all necessary actions in the SM chapter 6.
Carry out the listed points in addition to the technical safety
inspection.
108
109. 12. Current changing
Change over of
customers to
Spaceline
Order No.: 8707879
for
DC 2000 clip/adapter
109
110. 13. Documentation and Certification
•Summary
•open questions
•Handing out certificates and service seals to the participants
110
113. The Seal‘s Meaning
• Only use the Seal for B. Braun-Devices
• The Seal number is exceptional for your Personal use (related on
your name) and not transferable
• The Seal number are only allowed to stick on Devices which you
have been trained on (normally by a B|BRAUN certified Technical
Trainer)
• A virgin Seal upon the Device says that after your sealing, there
weren‘s anyone who‘s opened it
113
114. The Handling of the Seal
• After quitting the job as a Service engineer, please send us
(Technical Training Dept.) an information about it and destroy
your remaining seals
• In the moment you are receiving a new seal number all probably
existing older seal numbers on your name are invalid. Those older
numbers are going to be deleted at B|Braun
• Eventually remaining invalid seals have to be destroyed by
yourself
• If you change your employer, please order a new seal number (We
need your new companies complete address)
• Please order your seals like you order your spare parts (when
ordering, please write your seal number as clear as possible)
114
115. Pressure alarm Principle
Coil
Tube
Bearing
P-Cover Tube Expands
Door nose
Force transmitter
115
116. Software IFMe02003, IFM03003
IFMe02003, IFME03003:
Correction of Dianet Star
Only IFME03003:
Correction History
•protocols delivered Volume
•new event: normal mode/piggy mode
For Updates use only later Software !
116
117. Software IFMe02004, IFME03004
•New language „Hungarian“ in language group E
•Special function dose calculation changed:
•When changing concentration, weight and dose rate is cleared
automatically
•Correction of Dianet Star
117
118. Software IFMe02005, IFME03005
• Cyclical battery test
• Holding/clearing of the last dose calculation values when
powering off, selectable in service program
118
120. Air Bubbles
1 ml ~ a length of aprox. 14 cm in the PVC-tube
with 0.1 ml Bubble no alarm
with 0.4 ml Bubble alarm occurs
Infusomat Alarm Point:
between 0.24 and 0.36 ml at a alarm setting from 0.3 ml
(single bubble)
120
121. Staff Call
off on off
Operation
Switch On alarm
Test for example
On empty bottle
Opt. Alarm On
Switch On
Test
2 min
On
Audible Alarm On
switch on pulse,
Staff Call optional
ETI
Static Alarm
without off-alarm Run
ETI 1 sec
Dynamic Alarm
without off-alarm Run
ETI 1 sec 1 sec
Dynamic Alarm
with off-alarm Run
121
122. Changed Pressure Sensor threshold, electronic measuring
Pressure sensor OIL Space Line
Threshold
low 0,25…0,65 bar 0,21…0,61 bar
medium 0,55…0,95 bar 0,48…0,88 bar
high 0,90…1,30 bar 0,83…1,23 bar
mechanical max 1,35…1,76 bar 1,30…1,70 bar
min > 0,95 bar > 0,83 bar
The new Pressure Sensor threshold are valid by using an electronically Measuring
Instrument. By using a mechanically Measuring Instrument, the Values are expected
to be found up to 100 mbar lower.
122
123. Typical measuring mistakes
Reading mistake: Tube is hanging Measuring flask is
down in the closed!!
¯ lowest point
the
solution:
should be read! ¯smaller delivering-
¯finish too early! rate!
123