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Technical Safety Check TSC

Infusomat® fmS, 2.3 gb

7 - 3

Sheet 3 of 4

M670 00 00 92 F04 C 3891 2189 (GB)

Index d

(Master – to be added to the documentation)

Delivery accuracy

       Ambient temperature 20 ... 25 °C
       Delivery rate: 250 ml/h
       Measured volume: 25 ml

❒

Divergence (± 5%)

_______ %

Drop sensor

Delivery rate: 400 ml/h

❒

Drop sensor alarm, occlusion ______ s

(< 5s)

❒

Drop sensor alarm, flow

Air inline sensor

Delivery rate: 250 ml/h

❒

Water value (> 481 mV) _______ mV

❒

Air alarm

❒

Air value (< 78 mV)

_______ mV

❒

Threshold value (< 182 mV) _____ mV

Battery test

Operation mains/battery/mains:

❒

Uninterrupted operation

Switch on unit without mains connection

❒

Self-test is executed

Visual Inspection

Electrical Safety

according to IEC / EN 60601-1

or VDE 0750 and VDE 0751

Functional Inspection

(Part 3 of 3)

Содержание Infusomat fmS

Страница 1: ...Service Manual Infusomat fmS 0 Version 2 3 English 0 10...

Страница 2: ...fusomat fmS Turkish 871 5572 Voltages 100 V 110 V 120 V switchable Infusomat fmS English 871 5416 Infusomat fmS Dutch 871 5475 Infusomat fmS Spanish 871 5483 Infusomat fmS Portuguese 871 5394 This Ser...

Страница 3: ...ion Page 1 1 Operation Flow Chart Page 1 3 Function Page 1 4 Voltage Supply Page 1 5 Signal Table Page 1 6 Mains Operation Page 1 7 Battery Operation Page 1 8 Alarm Circuit Page 1 8 Pump Unit Page 1 8...

Страница 4: ...Maintenance Page 6 1 Technical Safety Check TSC Page 7 1 Procedural Instructions on the TSC Visual Inspection Page 8 1 Electrical Safety according to IEC EN 60601 1 or VDE 0750 and VDE 0751 Page 8 2...

Страница 5: ...ed in the current version of the manual as the TSC requires that the instructions in the manuals are ob served the manuals are a reference for measurements depending on the unit type the Service Progr...

Страница 6: ...uthorize the performance of repairs The in structions on electrostatic sensitive components ESD standards must be observed After repair a device check or diagnosis is to be carried out Notes on ESD Se...

Страница 7: ...nal or special notes concerning information and working steps CAUTION Is used for working steps which may result in damage to the unit system or to a connected device WARNING IS USED FOR WORKING STEPS...

Страница 8: ...wn but are used in this manual are listed below CC Computer Controlled CLR Clear Dig Digit ESD Electrostatic Discharge UA Unit Alarm FuP Function Microprocessor KuP Control Microprocessor LCD Liquid C...

Страница 9: ...International Technicians Intercompany Nadja Machal Fax 49 5661 75 47 89 e mail nadja machal bbraun com Service Hotline Karl Tippel Tanja K rdel Phone 49 5661 71 35 25 Fax 49 5661 71 35 26 e mail karl...

Страница 10: ...Contact Persons 0 0 10 Infusomat fmS 2 3 gb For your notes...

Страница 11: ...ng of the infusion pump Barcode A barcode label is attached to the left front side of new Infuso mat fmS unit versions which can be retrofitted on previous de vices This barcode label is used to read...

Страница 12: ...guished by the different silicone pump segments They have to be inserted in a different way in addition the TSC differs WARNING OPERATING THE UNIT ALTERNATELY WITH THE ORIGINAL INFU SOMAT LINE AND THE...

Страница 13: ...n Stop infusion Recall info Change delivery rate Recall Bolus 1 See Service Program diagram 2 Only when preselected time or preselected volume has expired 3 Please pay attention to activation in Servi...

Страница 14: ...encies and have access to different program and data memories All safety relevant functions are handled by both microprocessors and the results are counter checked CF and FC latch The input via the ke...

Страница 15: ...tor constantly monitors the 5V for undervoltage or overvoltage The function is checked during switch on The operating voltage UPS supplies the stepper motor and the UMOT the stepper motor drive The tr...

Страница 16: ...F Staff Call Relay Function Channel AK LAD Battery Capacity ON OFF PKSS Pump Head Sensor Control AK Test Battery Test PRS RUF Staff Call Relay Control ALA UB Operating Voltage Alarm RDE Rate Display...

Страница 17: ...n Channel TD A1 Text Display Address 1 FMC K FM Connection Control Channel TD A2 Text Display Address 2 UEXT N External 12V Supply TD A3 Text Display Address 3 UEXT P External 12V Supply TD E Text Dis...

Страница 18: ...alarm volume is about 65dBA 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 th...

Страница 19: ...ining 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...

Страница 20: ...it or in tegrated in an intensive care unit e g the B Braun fluid manager system fm system It is integrated by simply snapping the unit into the system Mains supply and data communication are automati...

Страница 21: ...3477 3223 Mounting clip for drop chamber Intrafix air 3477 3215 Drop sensor complete 3450 578A Short pole clamp 3450 5873 Drop chamber holder 3477 3088 Mains lead 200 240V 3450 2718 Mains lead 100 120...

Страница 22: ...System Overview 1 1 12 Infusomat fmS 2 3 gb For your notes...

Страница 23: ...formed e g instruct the user and exchange the instructions for use software coding e g IFME is to be found on the cover page of the instructions for use Note Do not use an update program on Windows NT...

Страница 24: ...changed to DIANET Star not compatible with Dianet New special function dose calculation New special function Piggyback New special function clock Storage of alarms in case of malfunctions which can b...

Страница 25: ...ation when unit is switched off can be set in the Service Program IFMe02006 IFME03006 Optimized switch off cycle of Service Program IFMe02007 IFME03007 Reset the battery capacity from 0 mAh to 1 mAH i...

Страница 26: ...ion Processor 80c535 Fig 2 2 7 segment display Text box Text Box Description 100 defective RAM memory 101 UMOT cannot be switched on 102 UMOT still switched on despite overvoltage 103 UMOT still switc...

Страница 27: ...y not present missing battery current FF03 defective RAM memory FF04 defective program memory FF05 defective program memory FF06 calibration data error from EEPROM FF07 pump head cycle not plausible F...

Страница 28: ...ated _______________________ Bolus deactivated _______________________ Standby activated _______________________ Drug selection deactivated _______________________ CC Mode 2 deactivated ______________...

Страница 29: ...ged Scale factor 54 _______________________ Unit specific data DIANET type no depending on unit _______________________ Unit No depending on unit _______________________ Operating hours depending on u...

Страница 30: ...Software 2 2 8 Infusomat fmS 2 3 gb For your notes...

Страница 31: ...d identification 120 0 Operating hours 200 0 Air inline sensor 300 0 Service language 400 0 Scale factor 510 0 Software version 100 0 Drug 110 0 Serial number 140 0 DIANET type no 150 0 Battery op hou...

Страница 32: ...ns are accessible including the disabled The special functions are slightly modified Example SM battery capacity has keys for 0 min 32 min presetting The battery capacity display switches between the...

Страница 33: ...ctions with NEXT Quit the Service Program 1 Press END in the main menu A data storage query is acti vated Save changes Yes No Y N terminates the Service Program Press END to jump to the last function...

Страница 34: ...line 3 with or 2 Repeat procedure for each character 3 Return to initial function with END Serial Number Function 140 0 The displayed serial number must correspond with the number on the unit type pla...

Страница 35: ...E on Test Air Inline Sensor Function 300 0 After exchange check the function of the air inline sensor See TSI List for permissible check values see Technical Safety Check TSC p 7 1 1 Press OK The rece...

Страница 36: ...ressure sensor unit must be mechanically adjusted see Pressure Sensor p 4 14 Unit Modifications Service Language Function 400 0 English or German can be selected 1 OK activates the function 2 Select l...

Страница 37: ...ions for use An additional switch on pulse YES NO can be activated for each mode to test the staff call unit 1 OK activates the function 2 Select staff call type with NEXT 3 Acknowledge with YES 4 Ret...

Страница 38: ...9 ml h 1 OK activates the function 2 Select min max delivery rate with NEXT 3 Acknowledge with YES 4 Enter value with a numeric key 5 Acknowledge with OK 6 Return to initial function with END Air Ala...

Страница 39: ...e scale factor can be set in the limits 40 to 99 digits Every digit step is equivalent to a 0 5 modification of the delivery rate An increase of the scale factor reduces the pump speed and a de crease...

Страница 40: ...ibrate see Pressure Sensor p 4 14 Pump Data Function 550 0 Note Compatibility between controller board and pump must be checked before acknowledgement Only press YES if pump corre sponds to controller...

Страница 41: ...check 4 2 Battery Designation Ord No Battery incl connector 1 2 AH 7 2 V and holder 3450 2556 Exchange 1 Switch off unit and disconnect from mains 2 Loosen screw open battery compartment cover and rem...

Страница 42: ...Mounting for door lock 3477 2790 Exchange 1 Open door and unlatch the spring holder 2 Remove countersunk screw and press out the mounting by pressing the holder for the door lock 3 Remove door lock i...

Страница 43: ...or pump cover lever 3450 5725 Exchange Tools Pin punch 1 8 mm pin punch 6 mm 4 mm gauge 1 Open door and remove hinge pin with pin punch 1 8 mm from below Do not lose torsion spring 2 Disassemble pump...

Страница 44: ...nd complete with rubber feet 3450 5415 Rubber feet 20 pcs 3477 3096 Unit handle with O rings and PT screws 3450 1789 Exchange 1 Remove battery see Battery p 4 1 2 Loosen 4 screws from the foot stands...

Страница 45: ...ether at the distance sleeves and remove board carefully 4 Pull off connector see figure 5 Exchange board or buzzer Fig 4 5 Flexible cable LCD module Pressure sensor Reed sensor Press snap in pin toge...

Страница 46: ...as assembled Check Safety check functional check 4 7 Rear Panel Designation Ord No Rear panel with screws M3 and seal 3450 1860 Cover for optical interface 3477 3164 Strip seal for rear panel 3477 314...

Страница 47: ...put open collector or standard 74HC level each with 220 series resistance Pin 5 Ub Output supply voltage Pin 6 MFC KAD Analog input K Pin 7 Emergency Off Input interface Pin 8 MFC FAD Analog input F P...

Страница 48: ...Infusomat fmS 2 3 gb Exchange Rear Panel 1 Remove battery see Battery p 4 1 2 Dismount cover see Housing and Handle p 4 4 3 Pull off rear panel connectors and loosen both screws on the unit bottom Fig...

Страница 49: ...upply and drop sensor see Fig 4 6 3 Loosen MFC socket with special socket spanner M18 4 Assembly is done in reverse order Exchange fm Recessed Plug 1 Loosen screws and nuts Note The new recessed plug...

Страница 50: ...ower supply unit Note The voltage selection for switchable power supplies is at the fuse element Exchange Drop Sensor Socket 1 Loosen nut and exchange drop sensor socket 2 Safety lock with Sicomet 50...

Страница 51: ...tersunk screws by piercing a screwdriver through the caps and remove caps Note Do not loosen the assembly screw on the lower pressure sensor board Otherwise the pump has to be recalibrated with a 4mm...

Страница 52: ...with a 4mm gauge 5 Pull off connector from controller board 6 Press down snap in pins from the inside and tilt pump for ward and unhinge 7 Assembly is done in reverse order Note Be sure that the cabl...

Страница 53: ...t entered Calibration data faulty may be displayed after the unit is switched on again 9 After ending the Service Program save the data The counters for operating hours battery operation and pump head...

Страница 54: ...holder Both boards are con nected via a flat cable 1 Dismount rear panel see Rear Panel p 4 6 or pump unit see Pump Unit p 4 12 2 Pull off the connecting cable to the microprocessor board 3 Loosen an...

Страница 55: ...OM of the exchanged light barrier board 9 Calibrate pressure sensor Note Calibration weights are required to calibrate the pressure sensor An alignment with infusion lines is not permitted a Clean the...

Страница 56: ...stage function 540 in the Service Program k Enter the calibration values via the keyboard and ac knowledge with yes l Quit Service Program and save data m Register the changed pressure values in the u...

Страница 57: ...lete sensor from behind and out of the frame 6 Insert new sensor and fasten cables firmly with cable ties Note Shielded air inline sensors are installed from serial no 34504 on Note Be sure that the c...

Страница 58: ...crews 5 Unlatch zero insertion force connector and loosen flex cable Note The position of the flex cable must not be changed i e the pre formed section must be in the hinge area pivot Mark cable if ne...

Страница 59: ...the type plate delivered Check Check that serial number and pump symbol in the plain text field of the barcode label correspond with the type plate on the pump of the Infusomat fmS 4 14 Frame with Sea...

Страница 60: ...Unit Elements 4 4 20 Infusomat fmS 2 3 gb For your notes...

Страница 61: ...voltage ______ V AC Protective conductor resistance incl mains cable 0 2 _______ Insulation resistance 2 M _________ Earth leakage current at NC 30 A ________ A Switch on unit Self test Audible alarm...

Страница 62: ...ty clamp flow inhibitor Pmin Delivery accuracy Ambient temperature 20 25 C Delivery rate 250 ml h Measured volume 25 ml Divergence Drop sensor Delivery rate 400 ml h Drop sensor alarm occlusion Drop s...

Страница 63: ...ing of the flow inhibitor clean and if neces sary exchange pressure springs 4 Check seal membrane and if necessary exchange 5 Check the drop sensor optics and spring mechanics and clean if necessary 6...

Страница 64: ...Maintenance 6 6 2 Infusomat fmS 2 3 gb For your notes...

Страница 65: ...age and readability of the additional labels on an Infusomat fmS set for the Infusomat Space Line Pump sealing diaphragm Membrane keyboard Rubber feet Operating unit Locking mechanism of the pump cove...

Страница 66: ...essure level high 0 90 1 30 bar ________ bar With Infusomat Space line Pressure level low 0 21 0 61 bar ________ bar Pressure level middle 0 48 0 88 bar ________ bar Pressure level high 0 83 1 23 bar...

Страница 67: ...very rate 400 ml h Drop sensor alarm occlusion ______ s 5s Drop sensor alarm flow Air inline sensor Delivery rate 250 ml h Water value 481 mV _______ mV Air alarm Air value 78 mV _______ mV Threshold...

Страница 68: ...________________________ MFC staff call line ____________________________ ____________________________ ____________________________ ____________________________ Calibrated for usage of Original Infuso...

Страница 69: ...usted for the Infusomat Space Line please see Fig 8 1 3 Check the Infusomat fmS and its accessories for damage and the labels for readability Pay special attention to the fol lowing parts a Pump seali...

Страница 70: ...ing at the connector of the FM connector Unit housing a If the unit is not sealed countersunk screw at the rear of the unit b If the unit is sealed remove lacquer from one of the holes in the foot sta...

Страница 71: ...nal Infusomat Line OIL If the unit is designed for an Infusomat Space Line then insert an Infusomat Space Line 3 Close door The door must lock smoothly and close correctly at the top and bottom 4 Carr...

Страница 72: ...n be used for the complete TSC incl functional check 1 piece or Infusomat Space Line new can be used for the complete TSC incl functional check 1 piece Infusion bag or bottle min 500 ml 1 piece Three...

Страница 73: ...specifications in the TSC 7 Check all pressure stages listed in the TSC and document val ues Pressure Limitation Mechanical The drop sensor must not be connected 1 Plug MFC service connector on the M...

Страница 74: ...e 2 Vent test setup Bottom part of drop chamber must be 2 3 filled 3 Insert cannula in empty graduated cylinder 4 Set delivery rate according to the TSC 5 Simultaneously start infusion and stop watch...

Страница 75: ...and close operat ing unit 3 Read off test value of the air inline sensor via the function 300 0 Air inline sensor in the Service Program see Air In line Sensor Function 300 0 p 3 5 4 Read off value af...

Страница 76: ...era tion 2 The symbol for the mains plug on the LC display goes off An error message is not triggered and operation of the unit is continued 3 Reconnect unit to the mains 4 The symbol for the mains pl...

Страница 77: ...disassembly of the pump cover 0770 1446 Pin punch 6 mm x 125 mm for hinge pin assembly of the pump cover 0770 1454 Flat tool 100 x 20 mm for assembly disassembly of the tube adapter 0770 1462 Special...

Страница 78: ...Test Equipment and Special Tools 9 9 2 Infusomat fmS 2 3 gb For your notes...

Страница 79: ...rews M3 and seal 3450 1860 Cover for optical interface 3477 3164 Strip seal for rear panel 3477 3142 MFC connector board 3450 3374 Potential equalization bolt 3477 0550 fm recessed plug 3 pin 3477 317...

Страница 80: ...ncl pressure spring and magnet 3450 1827 Flexible cable 42 mm 5 pcs 3477 3347 Hinge unit 3450 5571 Hinge pin 3 mm 3450 5580 Magnet 3450 5847 Designation Order No Frame with Seal Seal plate between fra...

Страница 81: ...hook 3450 8368 Plate 2 pcs 3450 2610 Connection cap D12 4 5 pcs 3477 4149 Bellows 5 pcs 3477 3274 Pressure spring 5 pcs 3477 4165 Designation Order No Universal Clamp Universal clamp complete not ava...

Страница 82: ...Spare Parts List 10 10 4 Infusomat fmS 2 3 gb For your notes...

Страница 83: ...ndle 4 4 Housing 4 4 L List of abbreviations 0 8 M Mains fuses 4 1 Mains operation 1 7 Maintenance 6 1 O Occlusion pressure electronic 1 9 mechanical 1 9 Operating unit 4 18 P Physical construction 1...

Страница 84: ...Index 11 11 2 Infusomat fmS 2 3 gb...

Страница 85: ...ist of spare parts Version 2 1 New TSI list New controller board New software Version 2 2 This version was approved by B Braun on 19 04 2006 The most important changes of this version are listed below...

Страница 86: ...Revision Documentation A A 2 Infusomat fmS 2 3 gb For your notes...

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