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Trainer guideline Infusomat fmS
incl. Infusomat P and Infusomat fm


Permitted to use by technical Trainers only

Version 1.3_gb
Used documents                             Preparation




• Instructions for use   Software IFME/IFMe

• Service Manual         Version: 2.1 English




                                                         2
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
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
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
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
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
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
6.1 The view        System overview


    Infusomat fmS




                                      9
6.2 Dimensions                      System overview




          H = 240 mm




                                        weight: app. 3,1 kg


                              m
                         0m
                         20
                       T=




                        B =140 mm                             10
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
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
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
6.3 Device and accessories   System overview


Drip sensor




Short stand with
holder for Drip
chamber
(optional)



                                                14
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
6.3 Device and accessories           System overview

  Light pulses
             10µs
                    1ms
                                                  1,0 A




 Receiving window

                             Frequency = 1kHz




                                                          16
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
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
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
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
6.4.1 The back                   The Infusomat® fmS

MFC =Multi Functions Connector




                                                      21
6.4.1 The back   The Infusomat® fmS




                                      22
6.4.2 The Bottom side   The Infusomat® fmS




Unit feed with
rubber elements
                               Battery
                               cover




                                                    23
6.4.2 The Bottom side   The Infusomat® fmS


Battery
compartment

with NiCd Battery
7,2V 1,2Ah.
delivered incl.
cover.




                                                     24
6.4.3 The Front (closed)   The Infusomat® fmS

    Handle

                                          Door opener

                                           LCD Display




                                            Key pad



Alarm- and operating
    indicator LED



                                                         25
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
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
6.4.3 The Front (inside)                The Infusomat® fmS


                  Anti Freeflow clamp




                                                         28
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
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
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
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
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
Infusomat fm/S/P – Air Trap Signal


Transmitter
                        39 V


         1 µs

  Receiver
                                     Alarm
                                     Threshold
                5 µs


                       20 µs
                                      next page
                                                  34
Infusomat fm/S/P – Test Value


Transmitter




Receiver                                           Alarm Threshold

              Measuring   Test Value   Measuring    Test Value
              Value                    Value




                                                                 35
6.4.4 The upper housing                       The Infusomat® fmS


                                                    Handle



                          Short instruction




                                                               36
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
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
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
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
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
6.6 Start of Infusion   System overview




                                          42
6.7 Additional settings              System overview


6.7.1 Online delivery rate setting

6.7.2 Volume preselection

6.7.3 Time preselection

6.7.4 Rate calculation

6.7.5 KOR mode (keep-open-rate)

6.7.6 Status request

                                                       43
6.7.1 Online Delivery rate setting   Additional settings




                                                           44
6.7.2 Volume pre-selection   Additional settings




                                                   45
6.7.3 Time pre-selection   Additional settings




                                                 46
6.7.4 Rate calculation   Additional settings




                                               47
6.7.5 KOR-Mode   Additional settings




                                       48
6.7.6 Status request   Additional settings




                                             49
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
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
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
6.8.1 Bolus function   Special functions




                                           53
6.8.1 Bolus                 Special functions

With volume pre-selection:




                                                 54
6.8.1 Bolus                     Special functions

Without volume pre-selection:




                                                    55
6.8.1 Interval bolus   Special functions




                                           56
6.8.2 Standby / Pause   Special functions




                                            57
6.8.3 Drug display   Special functions




                                         58
6.8.4 Occlusion pressure                         Special functions




Alarm reacting time in subject to the delivery
     rate and the chosen pressure stage




                                                                     59
6.8.5 Switch off drip control                  Special functions




Attention: please take care of the caution hint in the IFU!
(page 10)
                                                                   60
6.8.6 Check battery capacity   Special functions




                                                   61
6.8.7 Data lock           Special functions




                      .
                  .




                                              62
6.8.8 Loudness control                            Special functions

This function is only available in devices with
the Software version IFM E xxxxx.




                                                                      63
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
6.8.10 Set Date/time                          Special functions




Date and time setting is only be used in correlation with the
History-Function




                                                                  65
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
6.8.12 Piggyback                           Special functions

A complete information about the Piggyback-Function
see IFU page 12




                                                               67
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
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
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
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
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
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
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
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
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
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
7. Service Manual

 7.1 Overview

 7.2 How to handle

 7.3 Change control




                      78
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
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
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
8. Disassembly


 8.1 Required tools

 8.2 The procedure




                      82
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
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
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
9. Assembly


 9.1 Caution

 9.2 Typical faults




                      86
9.1 Caution                                        Assembly


 9.1.1 Cable routing

 9.1.2 Tips

 9.1.3 Special plastic screw

 9.1.4 Handling of pressure sensor and pump unit




                                                              87
9.1.1 Cable routing   Caution




                                88
9.1.1 Cable routing           Caution

                      • Motor cable routing
                        see photo left
                      • Cable should have no
                        contact to the gear




                                               89
9.1.2 Tips                 Caution

  Cable red   Cable blue




                                     90
9.1.2 Tips (PCB position)          Caution

                            Insert PCB in the last
                            possible guiding slot
                            (inner position)
                            upright mounting




                                                     91
9.1.3 Special screws   Caution




                                 92
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
9.1.4 Pressure sensor and pump unit Caution




Adjusting screw for
mechanical pressure
      cut off




 Never loosen this
     screw !!


                                                    94
9.1.4 Pressure sensor and pump unit Caution




                               Adjustment screw for basic
                              setting of pressure sensor by
                                using the 4mm template.




                                                              95
9.2 Typical Fault(s)                                    Caution


• It is impossible to turn on device.
  Reason: Rubber flex cable Front -> Controller board
• etc.




                                                                  96
10. Service Program and Calibration



 10.1   General

 10.2   With service plug

 10.3   Service Program
        (structure, opportunities)

 10.4   Preparing calibration




                                      97
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
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
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
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
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
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
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
11. Checking

 11.1 Checking after repair



 11.2 Preparing the TSC



 11.3 Maintenance




                              105
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
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
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
12. Current changing



                       Change over of
                       customers to
                       Spaceline


                       Order No.: 8707879
                       for
                       DC 2000 clip/adapter




                                              109
13. Documentation and Certification

 •Summary

 •open questions

 •Handing out certificates and service seals to the participants




                                                                   110
Thank you very much for your attention!




                                          111
Peristaltic Pumps




                    112
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
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
Pressure alarm Principle

                                                Coil
                        Tube
                                      Bearing
P-Cover              Tube Expands




 Door nose
                      Force transmitter




                                                       115
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
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
Software IFMe02005, IFME03005

• Cyclical battery test

• Holding/clearing of the last dose calculation values when
  powering off, selectable in service program




                                                              118
Software IFMe02006, IFME03006

•Power off sequence of service program is optimized




                                                      119
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
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
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
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
Correct Measuring Installation!




                                  OK!!




                                         124

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Tgl inf fm_s_1.31_gb

  • 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
  • 9. 6.1 The view System overview Infusomat fmS 9
  • 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
  • 22. 6.4.1 The back The Infusomat® fmS 22
  • 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
  • 42. 6.6 Start of Infusion System overview 42
  • 43. 6.7 Additional settings System overview 6.7.1 Online delivery rate setting 6.7.2 Volume preselection 6.7.3 Time preselection 6.7.4 Rate calculation 6.7.5 KOR mode (keep-open-rate) 6.7.6 Status request 43
  • 44. 6.7.1 Online Delivery rate setting Additional settings 44
  • 45. 6.7.2 Volume pre-selection Additional settings 45
  • 46. 6.7.3 Time pre-selection Additional settings 46
  • 47. 6.7.4 Rate calculation Additional settings 47
  • 48. 6.7.5 KOR-Mode Additional settings 48
  • 49. 6.7.6 Status request Additional settings 49
  • 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
  • 53. 6.8.1 Bolus function Special functions 53
  • 54. 6.8.1 Bolus Special functions With volume pre-selection: 54
  • 55. 6.8.1 Bolus Special functions Without volume pre-selection: 55
  • 56. 6.8.1 Interval bolus Special functions 56
  • 57. 6.8.2 Standby / Pause Special functions 57
  • 58. 6.8.3 Drug display Special functions 58
  • 59. 6.8.4 Occlusion pressure Special functions Alarm reacting time in subject to the delivery rate and the chosen pressure stage 59
  • 60. 6.8.5 Switch off drip control Special functions Attention: please take care of the caution hint in the IFU! (page 10) 60
  • 61. 6.8.6 Check battery capacity Special functions 61
  • 62. 6.8.7 Data lock Special functions . . 62
  • 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
  • 82. 8. Disassembly 8.1 Required tools 8.2 The procedure 82
  • 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
  • 86. 9. Assembly 9.1 Caution 9.2 Typical faults 86
  • 87. 9.1 Caution Assembly 9.1.1 Cable routing 9.1.2 Tips 9.1.3 Special plastic screw 9.1.4 Handling of pressure sensor and pump unit 87
  • 88. 9.1.1 Cable routing Caution 88
  • 89. 9.1.1 Cable routing Caution • Motor cable routing see photo left • Cable should have no contact to the gear 89
  • 90. 9.1.2 Tips Caution Cable red Cable blue 90
  • 91. 9.1.2 Tips (PCB position) Caution Insert PCB in the last possible guiding slot (inner position) upright mounting 91
  • 92. 9.1.3 Special screws Caution 92
  • 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
  • 111. Thank you very much for your attention! 111
  • 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
  • 119. Software IFMe02006, IFME03006 •Power off sequence of service program is optimized 119
  • 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