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EVENT MEDICAL Inspiration Ventilator Service Manual

1. Fab Test 5 Per the detailed instructions contained within section 5 of the service manual perform Fab Test 5 in order to re zero all pressure transducers Connect high pressure air and O2 source to the unit under test and ensure outputs are adjusted to 4 bar 1 bar Connect complete Paediatric patient system inclusive of exhalation cover diaphragm and proximal flow sensor Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 90 Using the rotary control knob select Paediatric tubing system and Standard settings Using the rotary control knob select Calibrations and perform all user calibration procedures System Test Flow Sensor and O2 Sensor Switch on PF300 and allow to warm up 15 minutes Once the PF300 has been allowed to warm up perform pressure sensor zero calibration and oxygen sensor calibration prior to proceeding On the PF300 proceed to the set up screen Configure the numerical screens as follows Numerical 1 Tidal Volume ml ATP Trigger Level 3lpm Respiratory Rate bpm Diff Pressure cmH20 Oxygen Operational Test 1 Gas Sources Connect test lung to the patient tubing system va 6mm ET tube Select Start to commence ventilation Allow device to cycle on standard settings with following exceptions Trigger Type Pressure Trigger Level 5cmH20 Verify that machine cycles with no alarms If any alarms are active adjust limits as necessary to elimina
2. Description Manufacturer Computer Minimum Win 95 Local Supplier Pentium based system Software Download Cable eVent Medical F910085 Inspiration Download Software eVent Medical Download exe Software File eVent Medical eventXYZ tim Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 ii Installation Process Pre Installation Tests Verify the operational status of the ventilator prior to proceeding with the software installation Switch subject ventilator ON in normal operation mode Verify that the subject ventilator completes self test without reporting technical errors Should any errors be reported refer to the Inspiration Ventilator service manual for further details and correct the triggering condition prior to proceeding Switch the device on in configuration mode On completion of power on self test record the Main SW Revision level from the start up screen Switch device off Verify that the software download utility is installed to desktop on your computer Installation of Inspiration system software requires the use of a proprietary download utility called download exe Download exe should be installed to desktop prior top commencing the software download process Download exe may be requested from eVent Medical directly or downloaded from the service section of our website http www event medical com On receipt install the utility program to desktop or to a convenient f
3. Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 21 3 3 2 4 Compressor air is routed to the main air supply system via a compressor Unloading Valve SV3 Unloading valve SV3 SV3 is a three way solenoid valve whose normally open port is connected to atmosphere As the internal compressor is started up SV3 will remain de energised briefly allowing the compressor to start up in an unloaded condition SV3 will then be energised to allow compressor output to be routed into the air supply system During internal compressor operation whenever the air supply valve SV2 is closed de energised SV3 will likewise be de energised allowing compressor gas to vent through its normally open port A muffler is provided on the normally open port of SV3 in order to silence the sound of the venting gas Muffler Unloading Valve Fig 3 9 Compressor Unloading Valve 3 3 2 5 The Inspiration gas reservoir RES serves as a store cnamber for mixed Gas Reservoir gas available for delivery to the patient The reservoir is made up of a number of separate chambers with a combined volume of approximately 1 litre The pressure inside the reservoir is controlled within a pressure range specific to the patient type selected Main Reservoir Compressor Chambers Inlet Chambers Fig 3 10 Gas Reservoir Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 22 3 3 2 6 Reservoir Pressure Transduce
4. The exhalation diaphragm under the force of the PV2 plunger will act against the seating surface of the exhalation cover to seal the patient tubing system The diaphragm is reusable and rated for 10 autoclave cycles Fig 3 22 Exhalation Components 3 3 6 3 The exhalation compartment comprises of a reusable cover and Exhalation System diaphragm which will act to seal the patient system under the control of Operation the expiratory proportional valve PV2 During Inspiration in volume targeted breath delivery PV2 will be controlled to the fully closed position applying the maximum closing force on the exhalation diaphragm Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 32 During Inspiration in pressure targeted breath delivery Pcontrol Psupport PV2 will normally be controlled to the fully closed position as above In the event of any pressure overshoot as might happen in the event of a patient cough PV2 will then be controlled proportionally using feedback from the internal pressure transducer P2 so as to maintain the target pressure During ex halation PV2 operation will be regulated using feedback from the internal pressure sensor P2 to achieve the operator set PEEP baseline Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 33 3 3 7 The oxygen monitoring system provides the operator with a real time Oxygen Monitoring indication of oxygen percentage
5. 3 Clear amp Test NVRAM recalibrate device 4 Replace controller PCB 1 Ensure that patient wye is open at the beginning of system test 2 Verify that PV1 is opening and flow is evident from to patient port 3 Replace Inspiratory Valve PV1 4 Verify no leakage through blender system 1 Ensure that that the flow sensor outlet is blocked during compensation test 2 Replace proximal flow sensor 3 Perform calibration of proportion valve PVI 1 Replace proximal flow sensor 2 Perform calibration of proportion valve PVI 1 Replace 02 Sensor 2 Perform NVRAM test 3 Clear amp Test NVRAM recalibrate device 4 Replace controller PCB 1 Ensure O2 supply is connected and adequate flow available 2 Ensure 02 Sensor connected correctly 3 Replace O2 Sensor 4 Confirm that inlet check valves CV1 2 are correctly installed and undamaged replace as necessary 5 Replace Sensor PCB 6 Replace O2 Sensor interface block Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 109 Error 4 Deviation High Error 8 Sensor Not Available Error 9 Oxygen Not Available Error during calibration at 21 setting Oxygen sensor is not available for calibration Oxygen supply not available for calibration 7 3 3 General Operation Errors High Priority Error No 40 Error No 41 Error No 42 Error No 43 Error No 44 Error No 45 Error No 46 Erro
6. High Temperature Alarm High External Voltage Alarm Low Pmean Alarm High Pmean Alarm Leak 7 3 5 General Operation Errors Information Info FIO2 and Delivery can vary Info Battery Not Available Info Logbook Cleared Info Memory CPU Not Protected Info Memory Sensor Not Protected Info Memory Power Not Protected Info Flow Trigger Not Available Info Nebulizer Not Available Pcontrol and or pressure max settings are incorrect i e Pcontrol gt pressure max Psupport and or pressure max settings are incorrect i e Psupport PEEP gt pressure max Not Used Internal battery voltage is low and will only sustain operation for a short period of time The internal temperature of the device is too high External DC supply voltage is too high Mean system pressure is too low compared with alarm limit for Pmean low Mean system pressure is too high compared with alarm limit for Pmean high The monitored Leak is too high compared with alarm limit for Leak The device is operating on internal compressor system The internal battery is not available Possible causes battery flat battery missing faulty cable connections The alarm log has been cleared Message will be displayed each time standard settings is selected CPU memory is not protected Sensor PCB memory is not protected jumper in place Power PCB memory is not pr
7. The Alarm Log lists the last 100 alarm events in chronological order along with the date and time of the occurrence The alarm log is accessed through the alarm menu screen which may be accessed at any time by pressing the Alarm Key on the ventilators front panel The contents of the alarm log will be retained when the ventilator is switched off When the ventilator is switched on and Last settings selected the contents of the alarm log will be available once more The contents of the alarm log may be cleared by selecting Standard settings from the start up screen following power on Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 115 8 5 High Priority Alarms Follows a full listing of alarms which will be classified a High Priority In each case a description of the error and the ventilator response is listed Alarm Message Battery Flat Occlusion High Pressure Internal Pressure Low Disconnect Low Pressure Low Minute Volume High Minute Volume Disconnection Low Oxygen Oxygen Too High Nebulizer Disconnect Low Tidal Volume High Tidal Volume Description of Error Internal rechargeable battery is flat Pressure at the start of Inspiration is too high Patient system pressure has reached the high pressure alarm setting Pressure within the gas reservoir is too low Pressure cannot be attained in the patient breathing circuit possible due to a l
8. Weight of stand 2 5 6 Operatin Environmental Data p 9 temperature Storage temperature Atmospheric operating pressure Operating altitude Oxygen inlet supply pressure Oxygen inlet supply flow Air inlet supply pressure Air inlet supply flow 16 x 16 x 21 40 x 40 x 53 cm 53 lbs 24 kg 27 lbs 12 kg 10 to 40 C at 10 to 80 relative humidity 10 to 60 C at 5 to 95 relative humidity 10 psi to 15 6 psi 700 to 1060 mbar lt 11 600 ft 3 500m above sea level 29 86 psi 2 6 bar 180 Ipm STPD dry required 29 86 psi 2 6 bar 180 Ipm STPD dry required Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 2 5 7 Technical Data 2 5 8 Compliance and Approvals Maximum limited pressure 120 cmH20 via a dedicated pressure relief valve Maximum operating pressure 80 cmH20 controlled by high pressure alarm setting Pressure measurements are made by solid state pressure transducers positioned to monitor internal operating inspiratory and expiratory circuit pressures operating ranges Ptank 0 14 7 psi 0 to 1 bar Ppat and Paw 100 cmH20 dP n O to 350 cmH20 dP pat and dPI cmH20 mbar Flow and volume measurement Flow measurements are made by one of two differential pressure flow sensors and are integrated with time to calculate inspiratory and expiratory volumes Flow and volume measurement ranges are listed
9. in NVRAM not valid 1 Replace Controller PCB 1 Replace Sensor PCB 1 Perform re zero of all pressure transducers Fab Test 5 2 Perform temperature drift adjustment Fab Test 12 3 Replace Sensor PCB 1 Replace Power PCB 1 Perform Checksum test on NVRAM Fab Test 3 2 Clear amp Test NVRAM and fully recalibrate the device 3 Replace Controller PCB 1 Clear Log Book 2 Clear amp Test NVRAM and recalibrate device 3 Replace Controller PCB 1 Perform rezero of all pressure transducers 2 Clear amp Test NVRAM and recalibrate device 3 Replace Sensor PCB 4 Replace Controller 1 Recalibrate internal flow sensor 2 Clear amp Test NVRAM and recalibrate device 3 Replace Controller PCB 1 Set appropriate altitude compensation value TF10 Technical Fault Program ROM Defective 1 Replace Processor PCB TF11 Technical Fault PIC Version Check TF12 Technical Fault Data not valid from ADC1 1 Ensure that Power and system software are at compatible revisions 2 Replace Power PCB 1 Ensure Sensor ribbon cable is seated correctly 2 Ensure Controller ribbon cable is seated correctly 3 Replace Sensor PCB 4 Replace Power PCB 5 Replace Processor PCB Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 50 TF13 Technical Fault Data not valid from ADC2 1 Ensure Sensor ribbon cable is seated correctly 2 Ensure Controll
10. 3 Replace Controller PCB TF06 Technical Fault Log Book data not valid in 1 Clear Log Book AVRAM 2 Clear amp Test NVRAM and recalibrate device 3 Replace Controller PCB TFO7 Technical Fault Pressure sensor offsets not 1 Perform rezero of all pressure valid in NVRAM transducers 2 Clear amp Test NVRAM and recalibrate device 3 Replace Sensor PCB 4 Replace Controller TF08 Technical Fault Internal Flow Sensor data in 1 Recalibrate internal flow sensor Role 2 Clear amp Test NVRAM and recalibrate device 3 Replace Controller PCB TFO9 Technical Fault Altitude Compensation data 1 Set appropriate altitude compensation in NVRAM not valid value TF10 Technical Fault Program ROM Defective 1 Replace Processor PCB TF11 Technical Fault PIC Version Check 1 Ensure that Power and system software are at compatible revisions 2 Replace Power PCB TF12 Technical Fault Data not valid from ADC1 1 Ensure Sensor ribbon cable is seated correctly 2 Ensure Controller ribbon cable is seated correctly 3 Replace Sensor PCB 4 Replace Power PCB 5 Replace Processor PCB TF13 Technical Fault Data not valid from ADC2 1 Ensure Sensor ribbon cable is seated correctly 2 Ensure Controller ribbon cable is seated correctly 3 Replace Sensor PCB 4 Replace Power PCB 5 Replace Processor PCB TF14 Technical Fault Difference of reference 1 Ensure Sensor ribbon cable is seated v
11. Inspiratory Valve PV1 replacement Fab Test 5 9 All Operation Tests 6 6 3 Internal Flow Sensor replacement Fab Test 5 7 All Operation Tests 6 6 3 Exhalation Valve replacement All Operation Tests 6 6 3 Blender Valve All Operation Tests 6 6 3 SV1 SV2 replacement SV3 Compressor replacement Gas Sources Test 6 6 3 Oxygen Sensor replacement Operation Test 4 6 6 3 Rotary Control Knob replacement POST Mains Inlet Filter replacement Electrical Safety Tests Fab Test 4 POST In order to perform the INSPIRATION ventilator system performance verification the manufacturer recommends the use of the following tools and test equipment Description Manufacturer Test Equipment Pneumatic Calibration Analyser eVent PF300 Electrical Safety Tester Biotek 601 Pro or equivalent Desktop Laptop PC Pentium Local Supply Adult Tubing System Local Supply Paediatric Tubing System Local Supply Proximal Flow Sensor Adult eVent Medical F910265 Proximal Flow Sensor Infant eVent Medical F910266 Exhalation Cover eVent Medical F710214 Exhalation Membrane eVent Medical F710213 Extended Ribbon Cable Test eVent Medical F810225 Lung Simulator Local Supply High Pressure Air Supply with Local Supply adjustable pressure regulator High Pressure Oxygen Supply Local Supply External Battery or DC Supply Local Supply Hexagonal Drivers following size Local Supply 1 5mm 2 0mm 2 5mm 3 0mm 4 0mm 5 0mm Inspiration Serie
12. Technical Fault Not Used Not Used TF23 Technical Fault Not Used Not Used TF24 Technical Fault Software Tasks Corruption 1 Replace Processor PCB TF25 Technical Fault Software Tasks Overflow 1 Replace Processor PCB TF26 Technical Fault NVRAM wrong checksum 1 Clear and test NVRAM then recalibrate device 2 Replace Controller PCB TF27 Technical Fault PV1 valve data not valid in 1 Perform calibration of PV1 NRE 2 Clear and test NVRAM then recalibrate device 3 Replace Controller PCB TF28 Technical Fault Difference between 1 Access Fab Test 2 and verify reading temperature sensors out of from temperature sensors range 2 Replace Sensor PCB 3 Replace Power PCB Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 105 7 3 2 Calibration Errors System Leak Test Error 6 Pressure Drop Error 7 Pressure Rise Error 8 Max Time To Pressure Error 10 Deviation High Error 11 Error Emptying Tank Flow Sensor Calibration Error 12 High Pressure Error 13 Deviation High Error 14 Deviation High Error 15 Deviation High Excessive Pressure Drop During System Test Excessive Pressure Increase During System Test Unable To Adequately Pressurize Patient System Flow At Transducer dP2 Out Of Range Tank Pressure Remains Above 100mbar Pressure Out Of Range Zero Adjustment dP2 Zero Adjustment dP3 Zero Adjustment P3 1 Ensu
13. between the blocks To remove the sensor PCB from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove the top cover enclosure 9 16 2 Remove the compressor platform 9 16 13 Using hex driver remove 4 x screws securing the security block to sensor block 2 Set security block on a secure clean surface for further disassembly To remove the over pressure valve from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove the top cover enclosure 9 16 2 Remove the compressor platform 9 16 13 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 134 9 16 30 Removal Of The Security Valve 9 16 31 Removal Of The Nebulizer Valve 9 16 32 Removal Of The Front Block 9 16 33 Removal Of The Exhalation Valve Remove the security block 9 16 28 Pull the over pressure valve cartridge out from the security block To remove the security valve from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove the top cover enclosure 9 16 2 Remove the compressor platform 9 16 13 Remove the security block 9 16 28 Lift top block from the security block Manually unscrew the security valve plunger from the actuator Set the plunger and top diaphragm aside Using hex d
14. 3 3 2 6 Reservoir Pressure Transducer P1 3 3 2 7 Tank Over Pressure Valve NN NINE WU N 0 0 0 0 NYO Ud dui RWW WwW W aa aan aaa a 0 0 0 0 c ada du di NNNNINNNINNIN O WN N OOO Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 3 4 3 3 2 8 Blender System Operation 3 3 3 Gas Delivery System 3 3 3 1 Delivery Proportional Valve 3 3 3 2 Internal Flow Sensor FS2 dP2 3 3 3 3 Internal Pressure Sensor 3 3 3 4 Breath Delivery Operation 3 3 4 Safety Valve Block 3 3 4 1 High Pressure Relief Valve HPRV 3 3 4 2 Safety Valve SV 3 3 5 Proximal Measurement System 3 3 5 1 Proximal Sensor 3 3 5 2 Proximal Transducers 3 3 5 3 Transducer Protection System 3 3 6 Exhalation System 3 3 6 1 Expiratory Proportional Valve PV2 3 3 6 2 Exhalation Diaphragm Cover 3 3 6 3 Exhalation System Operation 3 3 7 Oxygen Monitoring System 3 3 7 1 Oxygen Sensor 3 3 8 Nebulizer System 3 3 8 1 Nebulizer Solenoid SV4 Electronic Theory Of Operation 3 4 1 Power Input Components 3 4 2 Power Supply 3 4 3 Internal Battery 3 4 4 External DC Power 3 4 5 Power PCB 3 4 6 Sensor PCB 3 4 7 Controller PCB 3 4 8 Processor PCB 3 4 9 Graphic PCB 3 4 10 User Interface Display 3 4 11 Lexan Keypad 3 4 12 Rotary Control Knob 3 4 13 Mini Web Interface 3 4 14 Inverter PCB 3 4 15 DC DC Converter PCB Self Test And Configuration Menus 4 1 4 2 4 3 Introduction Power On Self Test 4 2 1 POST Errors S
15. 92008 United States Of America Phone 1 760 4319613 Fax 1 760 4317993 davidb event medical com service event medical com Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 Customer Distributor Details Company Name amp Address Customer Details Hospital Name Hospital Address Equipment Details Model TSerialNumber OE Ventilator Hours ACompressorHours SW Version pre service _ SW Version post service Power SW pre service Power SW post service Date of Installation JDateofEvent Details of Work Performed Problem Description Where possible please depict full contents of error and test logs Alarm Details PM Due FOOB Problem Resolution Describe actions taken to resolve the problem Was there a patient involvement S y of event and current condition Name amp Contact Details Details of medical professional confirming DORSI status Any other relevant information Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 ii Parts Used During Service Repair Part Number Description of Part SN Removed Sence Completed By Soure TCS Dae o SN Installed Warranty Claim Y N Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 THIS PAGE INENTIONALLY LEFT BLANK Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 Performance Ver
16. Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal fow sensor calibration recalibrate as necessary 6 Replace Sensor PCB Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 107 Error 20 Deviation High Error 21 Deviation High Error 22 Deviation High Error 23 Deviation High Differential pressure too high low flow level Coefficient a too low Coefficient a too high Coefficient b too low 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing
17. FIO2 and delivery can vary Battery Not Available Logbook Cleared Memory CPU not protected Memory sensor not protected Memory power not protected Flow trigger not available Nebulizer not available Description of Information Internal compressor is in use FIO2 and deliver may vary according to settings The internal battery is not available Possible causes battery flat battery missing faulty cable connections Standard ventilator settings have been selected during start up Alarm Log has been cleared EEPROM on the CPU is not write protected EEPROM on the Sensor PCB is not write protected EEPROM on the Power PCB is not write protected Flow triggering is not available Possible causes flow sensor is attached incorrectly flow sensor requires calibration Nebulizer is not available Ventilator Response Ventilation Continues Ventilation Continues Ventilation Continues Ventilation Continues Ventilation Continues Ventilation Continues Device switches over to a pressure trigger mode The nebulizer is switched off Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 118 100 O2 not 100 O2 function is not 100 O2 cannot be started and is available available therefore not displayed on the Possible causes oxygen supply Monitor not available while 100 O2 is being administered or 02 calibration has been started O2 calibration
18. Gain 85 10 mU mbar P3 Proximal Offset Zero 1296 mU Gain 24 96 mU mbar dP3 Proximal Offset Zero O mi Offset Drift 1326 mu Gain 53 50 mU mbar Oxygen Zero 0 92 mu _ Prev Next Fig 5 7 Technical Screen 6 Screen 7 Fab Test 7 Fig 5 8 will allow the trained service technician to perform calibration of the Internal Flow Sensor FS1 should it prove to be necessary FabTest7 Flow Sensor Adjust Preumat ics orf PUI CInsp gt PHM 0 00 Status Idle Bain Adjust Set Points 20 L min 50 l min 100 L min Flow internal 2 1 min Flow external BD imin Prev Next Fig 5 8 Technical Screen 7 Calibration of the Internal Flow Sensor will provide the valve controller Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 74 with a look up table for pressure signal mV as measured transducer dP2 versus flow for use during normal breath delivery This calibration should be performed following replacement of the devices Internal flow sensor F 910081 Motherboard PCB F 720510 Control PCB F 710510 or when performance testing indicates that it may be necessary To perform this operation a calibrated flow measurement device should be used eVENT Medical recommends the use of its PF300 Flow Lab or equivalent measurement device Test devices should be configured to measure Flow Air in ATP mode Only high pressure AIR should be used for this calibration process
19. Internal Pressure Sensor P2 3 3 3 4 Breath Delivery Operation Flow being delivered through the inspiratory proportional valve PVI is monitored at all times by the internal flow measurement system The internal flow measurement system consists of a resistive element FS2 which is positioned in the path of gas delivery and a corresponding differential pressure transducer dP2 which is located on the Sensor PCB Gas passing through the resistive element FS2 will cause a pressure differential which will be measured at pressure transducer dP2 Pressure measured at dP2 will be directly proportional to the gas flow across the resistive element The feedback from this sensor will be used by the microprocessor to regulate the operation of the proportional valve Fig 3 14 Internal Flow Sensor Element Blended gas being delivered through the Inspiratory valve PV1 also passes an absolute pressure transducer Feedback from this sensor is used by the microprocessor to regulate the operation of the delivery proportional valve during pressure targeted ventilation modes During operation all aspects of breath delivery will be regulated by the inspiratory proportional valve PV1 using feedback from the breath delivery transducers FS2 dP2 and P2 During Inspiration in volume targeted breath delivery PV1 will be regulated using feedback from the internal flow sensor FS2 dP2 so as to control the peak flow volume and breath shape Dur
20. Note Prior to performing this calibration procedure ensure that transducer dP2 has been correctly zeroed using Fab Test 5 e Connect an adjustable high pressure AIR source to the ventilators air inlet with output initially set for zero e Attach calibrated flow measurement device 0 150 Ipm to the main patient connector using single smooth bore tubing limb e Using the rotary control knob select and switch on the Pneumatics This operation will enable pneumatics master switch and open the air blender valves e Using the rotary control knob knob select and adjust the value of PVI to the fully open position 500 e Increase the supply pressure until a flow of 16 lpm 0 2 is observed on the flow measurement device e With 16 lpm flow present select the gain adjustment set point for 16 lpm The device will perform a self calibration and confirm when 16 Ipm point has completed successfully e With 16 lpm calibration complete increase the supply pressure once more until a flow of 50 Ipm 0 5 is observed on the flow measurement device e With 50 lpm flow present select the gain adjustment set point for 50 lpm The device will perform a selfcalibration and confirm when 50 Ipm point has completed successfully e With 50 Ipm calibration complete increase supply pressure once more until a flow of 100 lpm 1 0 is observed on the flow measurement device e With 100 lpm flow present select the gain adjustment set point for
21. US Note SPAP VTV Automode and Smart Sigh features are currently awaiting regulatory clearance in Japan and as such must always be configured to OFF when used in Japan Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 82 5 4 Service Screens On completion of each of the calibration and test routines which are Troubleshooting available in the service menu the device will report a pass or fail status In the event of a failure the device will report a specific error message indicating the nature of the problem The respective error codes A definition there of along with possible steps for resolution are listed in the table below Error Diagnosis Troubleshooting Fab Test 1 Valve Component Valve Component does not 1 Ensure Master is on does not cycle cycles when selected 2 Ensure that that relevant Output is on 3 Replace component relevant to the output 4 Replace Power PCB 5 Replace Processor PCB Fab Test 2 ADC 1 Error Error On ADC 1 1 Ensure that ribbon connector between Sensor and Power PCB is seated correctly 2 Replace Sensor PCB 3 Replace Power PCB 4 Replace Processor PCB ADC 2 Error Error On ADC 2 1 Ensure that ribbon connector between Sensor and Power PCB is seated correctly 2 Replace Sensor PCB 3 Replace Power PCB 4 Replace Processor PCB No Response From No machine response to 1 Ensure that ribbon cable from Lexan Pressed Button pr
22. Vbatteries internal battery voltage e Vexternal external DC supply voltage Additionally in this area of the screen the active power source status may be verified The following values may displayed at any time e Line AC power in use e Accu internal battery in use e External external DC supply in use Battery 2 x 12v This area of the screen will permit the service engineer to view information pertaining to battery condition and charging status The values available in this area are as follows e Battery Switch Provides an indication of the status of the 2 battery circuits e Capacity Current battery capacity as a value mAh and as a percentage of maximum capacity e Control Indicates whether battery charging is active ON denotes battery being charged OFF denotes no charging e Status Indicates whether battery is a function condition OK denotes battery OK and available for use or charging OFFLINE denotes battery which is damaged disconnected or in a severely depleted condition Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 11 Follows a brief table to illustrate how different combinations of values from the above parameters may be used to define the current condition of internal batteries and associated circuitry Ce o O OE Damaged 1 Internal battery voltage lt 10VDC 2 Battery charging circuit damaged Offline 1 Internal bat
23. as detailed in the following section To move between the available screens the technician should select next to move onto the next screen and previous to move back to the previous screen Screen 1 Fab Test 1 Fig 5 2 will allow the trained service technician to perform a manual check on a number of the circuits components within the pneumatic and electronic systems Using this tool each of the pneumatic valves and associated circuitry within the system may be energised in order to confirm correct operation When wishing to perform a test to a given pneumatic circuit the engineer should do the following Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 67 Master orr Fablesti Output ABU half orf SOLI 02 ort PUL Insp 0 SOL2 Aird orf PUZ Exp 0 SOL4 Neb orr Compressor off Nurse call Alarm LED ABU full orf SOL3 lt Comp gt OFF orf Buzzer Low off Next Buzzer Loud orf Slow Reserve orf Fig 5 2 Technical Screen 1 Fan speed Prev Using the rotary control knob navigate and select Master then switch the circuit on Note Master must be enabled before any of the pneumatic valves may be energised Once the master has been enabled navigate and select the valve or combination of valves to be tested then switch the circuit on Note Proportional valves once selected may be cycled through their full co
24. off as required to control the blender delivery exhalation nebulizer compressor and Safety Valve Drive circuitry for the audible alarm is also located within this PCB Pneumatic Safety Switch In the event of a technical error the pneumatic safety switch will allow all power to be removed from the ventilators pneumatics in a single operation Blender Pressure Measurement The circuit board contains two pressure transducers one differential transducer and one absolute transducer As has been described earlier there transducers are responsible for monitoring within the blender system The absolute pressure transducer will monitor the reservoir pressure The differential transducer is used in conjunction with the blender system flow sensor to determine the flow through the Air and O2 supply valves SV1 SV2 Input Output Interfaces The Power PCB contains the interface ports for three available communications interfaces all three interfaces for the Nurses call RS232 Mini web interface are in the form of an RJ45 connector Main Processor Supervision The power controller processor monitors at all times the operation of the main processor located on the controller PCB If it anytime it determines there is a problem which will compromise safe ventilator operation it will annunciate a technical error and put the unit in ambient breathing mode The purpose of the Sensor PCB located within the ventilator pneumatic chassis is to pr
25. to empty tank _ off orf Status Calibrated Pressure Adjust Set Points 399 mbar 800 mbar 1388 mbar Pi Tank 162 ubar Offset 218 0 00 PULCInsp gt PHM 9 0 00 Gain 77 30 00 bar Flow internal 2 2 l min Prev Noxt Fig 5 10 Technical Screen 9 Prior to performing this calibration procedure ensure that transducers P1 and dP2 have been correctly zeroed using Fab Test 5 Should calibration of PV1 prove necessary the following procedure should be performed With output set all the way off attach an adjustable high pressure air source to the ventilator Using the rotary control knob select and switch on the Pneumatics This operation will enable pneumatics and open the blender valves Ensure the P1 tank display reads Ombar 50mbar If reading is outside of this range select Nebulizer ON using the rotary control knob to relieve the tank pressure When pressure is observed to be within acceptable range revert the Nebulizer to OFF and continue with the calibration Adjust the output of the high pressure air source as necessary until a pressure of 300mbar 5mbar is observed at P1 Tank on screen Using rotary control knob select pressure adjust set point for 300mbar Observe that PV1 PWM value is increased until such time that a flow of 1 Ipm is detected by the internal flow sensor Proceed only when the device confirms successful calibration at this level When complete adjust the ou
26. 10 12 sensor Block 2 10 13 Patient Security Block 10 14 Front Pneumatic Module 10 15 Blender Module 10 16 Compressor Module 10 17 Ventilator Wiring 10 18 Ventilator Packaging Appendix System Software Installation Procedure Appendix Communications Interface Appendix Field Service Record 9 oa Appendix Performance Verification Record 165 167 168 169 170 172 174 A i B i C i D i Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 vi 1 Preface 1 1 Introduction This manual has been intended to provide the necessary information required to service and maintain the eVent Medical Inspiration Series Ventilator System It is intended for use by certified biomedical engineers or engineers with equivalent experience in the maintenance of respiratory life support equipment Engineers wishing to undertake the maintenance of the Inspiration ventilator system should attend a technical training seminar with eVent Medical 1 2 Copyright The information contained within this manual is the sole property of eVent Information Medical Ltd and may not be duplicated without permission This manual may be revised or replaced by eVent Medical Ltd at any time without notification You should ensure that you have the most current applicable version of this manual if in any doubt contact eVent Medical Ltd While the information set forth herein is believed to be accurate it is not a substi
27. 100 Ipm The device will perform a self calibration and confirm when 100 Ipm point has completed successfully Calibration is now complete e Disconnect the test flow meter from the main patient connector and adjust the gas pressure source back down to zero Using rotary control knob select and adjust PV1 to read 0 select and switch off the pneumatics Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 75 5 3 8 Screen 8 Calibration Data 5 3 9 Screen 9 PV1 Calibration Screen For reference purposes at the bottom of this screen a measurement of Flow internal measured at FS2 dP2 and Flow external measured at FS3 dP3 if connected is provided Screen 8 Fab Test 8 Fig 5 9 will allow the trained service operative to view specific calibration values relating to the proximal and delivery flow sensors and to the Oxygen measurement cell Calibration Value Fablest Int Flow Sengor dP1 2 18 mbar dP2 5 80 mbar dP3 13 32 mbar Gaini 9 2 lpm mbar Bain2 8 2 lpmembar Gain3 6 6 1pmmbar Gains 5 3 lpmmbar Oxugen Sensori Gain 0 46 02 10mU Offset 0 1 02 Coeff a 0 00078 mbar lpm 2 Coeff b 0 00316 mbar lpm Ext Flow Sensori Preu Next Internal Flow Sensor This function permits the service engineer to observe the differential pressure and associated gain for each of the flows defined during calibration 16 50 100 LPM Fig 5 9 Technical Screen 8 O2 Sensor T
28. 2 Re zero pressure transducers as in Fab Test 5 3 Re perform calibration procedure 4 Replace PV1 Valve 1 Ensure that supply to device is stable and holding at required level 2 Replace PV1 Valve Fab Test 10 Error Temperature In adequate temperature rise during drift dP2 Drift Error Excessive drift on dP2 dP3 Drift Error Excessive drift on dP3 1 Allow device to cool down and then re run temperature drift ensuring that the compressor or test fixture is installed and functional 1 Allow device to cool down and then re run temperature drift 2 Replace Sensor PCB 1 Allow device to cool down and then re run temperature drift 2 Replace Sensor PCB Fab Test 13 No relevant errors N A N A Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 85 THIS PAGE INTENTIONALLY LEFT BLANK Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 86 6 6 1 Introduction 6 2 Notes 6 3 When To Run Tests Field Verification Procedure This section of the manual describes the performance testing procedures which should be performed on the device periodically to ensure operation top the manufacturers specifications Note The Inspiration ventilator system is manufactured with accurate pneumatic and electronic test equipment in a controlled envi ronment As field conditions vary the accuracy of measurement devices becomes less certain The following test spe
29. 3 3 5 3 Transducer Protection System Fig 3 19 Flow Sensor Interface Nebulizer Module In order to provide a measurement of the proximal airway pressure a tap is taken off of the downstream sensing line and applied to the proximal pressure transducer P3 The pressure transducer is located on the Sensor PCB and interfaces directly at the pneumatic block To prevent internal contamination of the proximal sensing lines and damage to the pressure transducers a positive purge flow is provided down through the pneumatic chassis and the sensing lines from the pressurised reservoir system This purge flow is developed by two restrictors one for each sensing line which interface at the Inspiration reservoir and sensor block 2 In order to prevent damage to the differential pressure transducer dP3 which may result from an occlusion of the proximal sensing lines the system incorporates over pressure protection Over pressure protection is in the form of 2 check valves which connect the 2 proximal sensing lines and which are biased so as to allow flow between the lines in either direction These check valves CV3 CV4 have a cracking pressure of 100mbar In the event of either of the proximal tubes becoming occluded the check valve will crack open at this pressure allowing a bleed across and into the other line equalising the pressure at the transducer Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 30
30. Block Wye Once acknowledged a fow of 6 Ipm will be delivered into the patient tubing in order to pressurise the system Once the system pressure has reached 10cmH20 compliance and flow detection will be started System will be pressurised up to a maximum of 50cmH20 after which compliance and flow detection will be stopped The device will allow 1 second for the system pressure to stabilise and will then hold the system closed PV1 and PV2 fully closed for a further period of 4 seconds in order to monitor the pressure drop Pass or fail status will be reported along with the compliance factor Note System test may be performed using either external gas sources or the internal compressor system In order to run system leak test the following procedure should be followed e Attach the complete patient tubing system including proximal sensor to the ventilator e Using the rotary control knob select System Test from the pull Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 54 4 3 2 Proximal Flow Sensor Calibration down calibration menu e When ready select Start in order to commence the test procedure e The initial series of tests require the wye piece be left open e After a brief pause the device will prompt the operator to Block Wye do so using either a sealing bung or similar device e On completion of the test the device will report a pass as OK accompanied by lea
31. CC CC CCCC ERROR XX A Position within the event log where 1 is the most recent event B Time the event occurred in 24 hour format C Date on which the event occurred XX Two digit number representing the type of even which occurred Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 79 5 3 12 Temp Drift Compensation For a detailed description of each error and associated troubleshooting data please refer to section 7 of this service manual Technical Screen 12 Fig 5 13 will allow the trained service technician to perform a temperature drift compensation for the differential pressure transducers dP2 Internal flow sensor and dP3 proximal flow sensor FabTest12 Actual Offset dP2 542 mU at 24 2Centigrade Actual Offset dP3 2085 mU at 24 2Centigrade 1 Sample dP2 mU at Centigrade 2 Sample dP2 mU at Centigrade Temperature drift dP2 8 357 mU Centigrade 15 Sample dP3 mU at Centigrade 2 Sample dP3 mU at Centigrade Temperature drift dP3 0 150mU Centigrade Drift Ok a TITE Tr Next Fig 5 13 Technical Screen 12 Temperature drift compensation should be performed when performance testing indicates that it may be necessary Note that if performing temperature drift compensation on devices without internal compressor module it will be necessary to use temperature drift test fixture F 721601 Note Observe the temperature display at top of fab test 12 screen Dri
32. EPROM With Power PCB rev 03 and below power system software is stored on a socketted EPROM which must be physically replaced when modifying the software version Power Processor Reset Resident on the rev 04 PCB adjacent to the flash EPROM is a power processor reset switch This switch will be used as required when installing power system software and may be used during troubleshooting Power Source Control The Power PCB will monitor the three available power inputs and control switching between them AC supply is always the first priority and will power the unit if available In the event of a loss of AC power the 24 VDC from the power supply will be lost the processor will look to see if external 24 VDC is available and if so will switch to it if external DC is not available the unit will switch to its internal 24 VDC battery The Power PCB is also responsible for the internal battery charging and monitoring functions The internal battery will be charged at all times when AC or external DC supplies are connected to the ventilator regardless of whether the unit is switched on Pneumatic Control Drive circuits located on the Power PCB are Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 41 3 4 6 Sensor PCB responsible for the control of all the valves within the pneumatic block As instructed by the main processor located on the controller PCB this circuitry will switch the valves on
33. Indexed Safety System connectors On entry the gas is conditioned in order to prevent any moisture or large contaminant particles from entering the system Two supply valves will meter the amount of air and oxygen to be supplied downstream to a 1 5 litre reservoir Gas to be supplied to the patient system exits the reservoir via a proportional valve which is software controlled using feedback from system of inspiratory sensors Having passed through the proportional valve the delivered gas exits the device via a 22mm male connector Control of exhalation is provided by a second proportional valve acting upon a diaphragm in the exhalation system Pressure sensors and flow sensors pneumotachometer are used throughout the system to provide feedback measurements to the microprocessor After undergoing digital conversion these measurements are used actively in the calculations which control breath delivery Ventilation parameters are programmed by the operator using the Push amp Turn device on the user interface in conjunction with the selectable screen displays The programmed data will be processed by the microprocessor and stored in ventilator non volatile memory The microprocessor will use the stored data in the control of breath delivery Power to operate the device may come from AC mains supply external 24 VDC battery supply optional or from its own internal 24 VDC battery supply In the event of a loss of AC the unit will be powered by a
34. MWI application and applet software files must be installed following the repair Refer to appendix A for detailed instructions To remove the Processor PCB from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove top cover enclosure 9 16 2 and place on static dissipative mat if Inspiration LS separate PU front bezel from front housing 9 16 3 With attention to appropriate anti static precautions and using 2 5mm hex driver remove 4 x Cap Head screw securing the Processor PCB to the Controller PCB Carefully unplug the Processor PCB from the Controller PCB and place into static shielding bag Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 126 9 16 7 LCD Display Removal Installation 9 16 8 Graphic PCB Removal Installation Note Replacement Processor PCB s are provided in an un programmed state Ventilator system software must be installed following the repair Refer to appendix A for detailed instructions To remove the Graphic PCB from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove top cover enclosure 9 16 2 and place on static dissipative mat if Inspiration LS separate PU front bezel from front housing 9 16 3 Disconnect ribbon cable from rotary control knob from the Controller PCB Disconnect ribbon cable from the lexa
35. Pa is provided The measurement from this PCB will be used for correction of other pressure measurements The Motherboard Controller PCB provides the primary interconnect and communication bus between the pneumatic chassis electronics the Processor PCB Graphic PCB Mini Web PCB Lexan Front Panel Interface and the backlight Fig 3 30 Controller PCB PCB Configuration Dependant upon whether the device is in the LS ST configuration or in the Original configuration will be determine whether the PCB in use is designated as a Motherboard or Controller PCB where the LS ST will use the Motherboard Rev 03 and above and the Original device will use the Controller PCB Rev 02 and below NVRAM Resident on this PCB in each configuration is an NVRAM device Critical data such as calibration look up data breath and alarm settings date and time running hours alarm log etc will be stored on this device The information will be retained on this device using a socketted lithium battery which is rated for approximately 10 years continuous storage Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 43 Dual Port RAM A dual port RAM device is provided on the PCB for temporary data storage for mini web interface applications Service Switch A single slide switch is provided on the PCB which will allow the device power up directly into the service mode as may be required for troubleshooting purposes B
36. Section Through Check Valve Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 19 3 3 2 Gas Blending System 3 3 2 1 Gas Supply Solenoids SV1 SV2 3 3 2 2 Blender Flow Sensor FS1 DP1 Gas blending in the Inspiration ventilator system is achieved through use of two high flow solenoids and a blender flow sensor The solenoids are microprocessor controlled using feedback from the blender flow sensor so as to keep the 1 litre reservoir adequately charged with the correct mixture of Air and Oxygen The system also incorporates a back up compressor which will be started automatically in the event of a loss of the high pressure air source supplying the ventilator a SV2 Air SV1 Oxygen Fig 3 6 Blender Assembly Two gas supply solenoids shown fig 3 6 are incorporated into the blender system and are energised during each mixing cycle to ensure that the correct mixture of gas is maintained within the reservoir Solenoid 1 SV1 controls the flow of oxygen through to the reservoir Solenoid 2 SV2 controls the flow of air through to the reservoir Flow being delivered through SV1 Oxygen and SV2 Air during each of the blending cycle is measured by the blender flow measurement system The blender flow measurement system consists of a resistive element FS1 positioned in the path of blender gas flow and a corresponding differential pressure transducer dP1 which is located on t
37. V CMV mode set rate x set tidal volume 50 All other modes monitored ExpMinVol 50 1 to 80 cmH20 Auto all modes monitored Pmean 10 cmH20 1 to 79 cmH20 Auto all modes monitored Pmean 10 cmH20 10 to 2500 ml Uses inspiratory tidal volume if proximal sensor is disabled Auto V CMV V SIMV PRVC CMV PRVC SIMV VS set tidal volume 50 All other modes monitored tidal volume 50 0 to 2490 ml Uses inspiratory tidal volume if proximal sensor is disabled Auto V CMV V SIMV PRVC CMV PRVC SIMV VS set tidal volume 50 All other modes monitored Vte 50 10 to 2500 ml Uses inspiratory tidal volume Vti if proximal sensor is disabled Auto V CMV V SIMV PRVC CMV PRVC SIMV VS set tidal volume 60 All other modes monitored tidal volume 60 Automatic alarm set to 7 without compressor or 15 with compressor above oxygen setting Automatic alarm set to 7 without compressor or 15 with compressor below oxygen setting Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 8 Leak Rate maximum leak Apnea Interval 2 5 5 Physical Data of device Weight of device Weight of stand 1 Vte Vti 3 to 60 seconds Inspiration Ventilator System Width x depth x height 13 x 15 x 19 33 x 38 x 48 cm 48 Ibs 22 kg 27 lbs 12 kg Inspiration LS Ventilator Width x depth x height of device Weight of device
38. a 5 7 14 VGA display panel As determined by operator keystrokes to the keypad the display will Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 45 3 4 11 Lexan Keypad 3 4 12 User Interface Rotary control knob provide numerical data graphical data settings data special functions data and alarm setting data Through other dedicated functions the display also permits the device to be configured calibrated and adjusted for patient use Incorporated within the display assembly is a CFL backlight assembly The LCD panels for LS ST incorporate dual backlights where as the Original LCD panel incorporates a single backlight The lexan keypad incorporates a total of nine buttons which permit the operator to power the ventilator on off and allow them select the active screen for display on the flat panel LCD display Additionally the keypad incorporates two embedded LED s which will be illuminated to indicate alarm conditions and that AC power is connected to the device Fig 3 34 Keypad Assembly The operation of the rotary control knob permits the operator to select and change ventilation modes and settings The device comprises of a 16 position rotary encoder permitting navigation and adjustment of ventilator settings Fig 3 35 Rotary control knob Assembly Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 46 3 4 13 The Mini Web Interface PCB is an optional
39. are prompted at this point to reset the subject device If the device is off simply switch ON within the 30 second time window if it is on already simply switch OFF then ON once more within the 30 second time window Ferrera Dowrlead Wizard IMT Information Man agement Technology AG ss ESA Senne Consecion and Download Flema HO Rea reset pour CAS turmo poner ott nnd an ogun CA UT e a COM a Y Nordeeideriicahor VA 0 Tio dw ru ii could ner te Gotected Fe hon Corna Fo 004001 Ih Fidias FEAU Hmm tarmente kz peue dele e e puta WARING Darst marat be dririozi nocd unta Estnyed tre rnsrirg jens 13 00 Emgesa tay AL for miodal e Figure 5 Download Progress Screen Observe the screen for confirmation of a successful connection then select Next to proceed to the next step In the event that connection is not confirmed repeat the complete process and troubleshoot connections as is necessary With a successful connection the next screen will confirm that the device is ready for download Select Start Download and the process will commence The download will take approximately 6 minutes in total and progress may be monitored by means of the download progress bar shown on the screen and also in figure 5 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 vi CAUTION The download procedure should not be interrupted once it is in progress The download window will conf
40. corrected Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 117 Low Priority Alarms Information Messages Check Psupport Pmax Battery Low High Temperature External voltage too high Pmean Low Pmean High High Leak Psupport and or high pressure alarm settings are incorrect ie Psupport gt high pressure alarm setting Internal battery voltage is too low The temperature inside the device is too high The external DC supply voltage is too high Patient system mean pressure is too low compared with the set alarm limit for Pmean Patient system mean pressure is too high compared with the set alarm limit for Pmean Monitored value for Leak is too high compared with the set alarm limit for Leak Ventilation Continues Pressure support will be limited at the high pressure alarm setting until the settings are corrected Ventilation Continues Ventilation continues Ventilation Continues Ventilation Continues Ventilation Continues Ventilation Continues Follows a full listing of alarms which will be classified a Low Priority In each case a description of the error and the ventilator response is listed Alarm Message Description of Error Ventilator Response N A N A N A Follows a full listing of alarms which will be classified a High Priority In each case a description of the error and the ventilator response is listed Message
41. delivered to the patient It incorporates OS an Oxygen Sensor OS using a galvanic measurement technique to produce an output voltage proportional to the partial pressure of the sampled gas The sampled flow will be developed from the reservoir through a restrictor and directed to the centre of the measurement cell to allow measurement to be taken Oxygen measurement may be enabled disabled in the configuration menu When activated a preset alarm will be triggered if the delivered 02 percentage falls outside of the required ranges The alarm range for O2 measurement is set at 5 fiO2 02 Nozzle Fig 3 23 Oxygen Sensor Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 34 3 3 8 The Inspiration ventilator incorporates a smart nebulizer system At the Nebulizer System programmed intervals the ventilator will provide gas to drive an optional nebulizer incorporated into the patient system The flow required for nebulizer operation is developed by the restriction of the nebulizer solenoid SV4 orifice whose inlet side interfaces directly at the reservoir This pressurised flow of blended gas from the reservoir is applied through a front bezel tubing connection to the nebulizer vial in the patient system The flow of gas into the tubing system is turned on and off by means of a normally closed solenoid valve located on the nebulizer module Fig 3 24 Nebulizer Module Inspiration Series Technica
42. device to be configured for all available language types or for English language only US If set for all the language may be set in configuration screen 3 e Exhalation Valve Allows the technician to set according to the revision of expiratory valve which may be installed in the device Inspiration model ST and LS should always be configured at Rev 04 and above Original Inspiration models should be configured as appropriate e Compressor Allows the technician to set according to the revision of compressor installed in the device Inspiration model ST and LS should always be configured at 8009 not JP model Original Inspiration models should always be configured at 8006 Japanese JP ventilator models should be configured at No Compressor e SPAP VTV Autom Allows Smart Positive Airway Pressure SPAP Volume Target Ventilation VTV Automode modes to be configured on or off per market requirements e Smart Sigh Allows Smart Sigh to be configured on or off per market requirements e Nebulizer Interval Allows the nebulizer interval smart nebulizer to be configured on or off per market requirements e Rexp Allows Expiratory resistance measurement to be configured on or off per market requirements e RS232 Keepalive Allows the RS232 timeout to be disabled Note Nebulizer Interval and Rexp features do not have regulatory clearance in the US and as such must always be configured to OFF when used in the
43. free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 58 E
44. is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 59 Error 24 Deviation High Error 25 Saving Data Error 26 Emptying Tank Error 27 Low Pressure Error 28 High Pressure Oxygen Sensor Error 2 Saving Data Error 3 Deviation High Coefficient b too high NVRAM Damaged Error Emptying Tank Pressure P2 lt 15 mbar Pressure P2 gt 40 mbar NVRAM Damaged Error during calibration at 100 setting 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB 1 Replace proximal sensor 2 Perform NVRAM test 3 Clear amp Test NVRAM recalibrate device 4 Replace controller PCB 1 Ensure that patient wye is open at the beginning of system test 2 Verify that PV1 is opening and flow is evident from to patient port 3 Replace Inspiratory Valve PVI 4 Verify no leakage through blender system 1 Ensure that that the flow sensor outlet is blocked during compensation t
45. keys may be confirmed This may be done simply by pressing the desired front panel key then observing the appropriate area of the screen for the correct response Fig 5 3 Using Fab Test 2 allows the internal ventilator temperature as measured on both Power PCB and Sensor PCB to be reviewed Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 69 Screen 3 Peripheral Screen 3 Fab Test 3 Fig 5 4 will allow the trained service technician to perform a check on installed software revisions and permit a check sum pattern test to be performed on various areas of EEPROM Fablest3 Peripheral Memories NURAM Clear Check Status Def aul tl None Board mon Sensor Check Board versioni Jumper 1 Not present RO Versions Status SW ventilator 1 0 4 SH power 2 6 20 None HH power 0 1 HW controller 0 1 HH sensor 0 1 Prev Nox ti Fig 5 4 Technical Screen 3 Check NVRAM Using this function will perform full checksum pattern test of the NVRAM device EEPROM Board This function will reveal a pull down menu allowing the engineer to select which board will be available for test The technician may select from the following e Sensor PCB e Power PCB e Processor PCB Check EEPROM Once the appropriate board has been selected this function may be used to perform a full checksum pattern test of its EEPROM devices Board Version This function allows the revision of the selected P
46. repair To prevent personal injury or death do not attempt any service to ventilator while a patient or other person is connected to it To prevent electric shock hazard always ensure that all electrical power has been removed from device prior to commencing service This statement requires that not only mains power be removed but also the devices internal batteries and any external DC source as applicable If the device must be serviced with the power on be careful to avoid electrical shock At all times follow accepted safety practices for electrical equipment when performing any repairs To prevent possible personal injury always ensure that high pressure air and oxygen sources have been removed To prevent possible personal injury and equipment damage never attempt to push or pull a ventilator installed on its stand with the brakes set on To prevent possible personal injury and equipment damage always ensure that the brakes are set on to prevent inadvertent movement when performing service 9 3 Repair Guidelines The following general guidelines should be considered at all times when performing service to the Inspiration ventilator system Follow repair safety guidelines at all times The majority of hardware on the ventilator system is metric sized Always ensure that only metric tools are used when performing service Use of non metric tooling may result in damaged hardware To prevent any possible damage caused by electrostatic dis
47. reservoir to maintain the current ventilator settings The microprocessor decisions take into account set delivery parameters base flow proximal purge flow O2 sensor flow all which draw upon the main reservoir At the initiation of each blending cycle the microprocessor determines what volume of gas is required from each of the supply systems in order to recharge the reservoir appropriately The supply valves SV1 and SV2 will then be activated sequentially to supply these requirements As the first valve is activated the microprocessor will monitor the flow being delivered through it at FS1 dP1 Blender Flow Sensor When it Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 23 determines that the appropriate volume of gas has been delivered the valve will be closed After a brief pause the second valve will be activated monitored and closed in the same way Working in this way by activating the valves only as long as required the microprocessor maintains an accurate gas mixture regardless of the supply conditions Were the gas supply pressure and flow to drop the microprocessor will extend the operation time until the required volume is delivered in order to compensate Likewise if the pressure and flow were to increase the supply valve will be energised for a shorter period of time With adequate high pressure air and oxygen sources available the blender will function as described above and will maintai
48. screen 1 record the measured value of PEEP Ensure that PEEP is 50cmH20 5 Record result on the final test record Switch UUT screen to show Monitoring ensure that devices PEEP reading is 50cmH20 5 Record result on the final test record Operational Test 4 Oxygen Delivery Adjust the ventilator settings as follows ee TV Respira Rate wem Allow a minimum of 2 minutes for the device to stabilise at the current ventilation settings Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 97 On the PF300 numerical screen 2 record the measured value of Oxygen Ensure that Oxygen is 30 3 Record result on the final test record Switch UUT screen to show Monitoring ensure that devices Oxygen reading is 30 3 Record result on the final test record On completion make the following changes to the ventilator settings ee Allow a minimum of 2 minutes for the device to stabilise at the current ventilation settings On the PF300 numerical screen 2 record the measured value of Oxygen Ensure that Oxygen is 60 3 Record result on the final test record Switch UUT screen to show Monitoring ensure that devices Oxygen reading is 60 3 Record result on the final test record On completion make the following changes to the ventilator settings nio TO Respiratory Rate Allow a minimum of 2 minutes for the device to stabilise at the current ventilation setting
49. setting of the date will ensure the accuracy of records stored within the alarm and technical error logs Service Code Allows the operator to define a 4 digit code for use on entry of the configuration menu The default code of 1998 is always available as a backup Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 64 ar yr ge El 31 na 15 43 ater 15 A 11 24M arvice het A Back Exit Fig 4 7 Configuration Screen 2 4 4 4 Configuration screen 3 will permit the operator to configure specific Configuration Screen 3 attributes which allow data from the Mini Web Interface MWI to be accessible via a local area network or direct PC connection NB This screen will only be accessible if a device has the MWI hardware installed along with all applicable MWI software files SW web server Indicates the application software version currently installed to the mini web interface PCB Mac address Indicates defined Mac address for the mini web interface This may be required by network administrator to complete access through local area network IP address Permits the user to assign the mini web interface with an individual IP address required for local and LAN connection Subnet Mask Permits the user to assign the mini web interface with the subnet mask details required for local and LAN connection Default Gateway Permits the user to assign the mini web interface
50. supply module into a static shielding bag To remove the sensor PCB from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove top cover enclosure 9 16 2 and place on static dissipative mat Remove the compressor platform 9 16 13 Disconnect the flat ribbon cable from the Power PCB at the sensor PCB end Disconnect O2 sensor interface cable from the Sensor PCB Using 2 5mm hex driver remove the 1 x cap head screw securing the sensor PCB to the pneumatic module access through right side cut out Ease the sensor PCB up out of the pneumatic module Care should be taken not to flex the PCB excessively or damage the transducer connections Place the sensor PCB into a static shielding bag To remove the Power PCB from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove top cover enclosure 9 16 2 and place on static dissipative mat Remove the compressor platform 9 16 13 Disconnect flat ribbon cable from the sensor PCB at the Power PCB end Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 130 9 16 18 Air 02 Inlet Assembly Removal Installation 9 16 19 Air 02 Inlet Filter Removal Installation Disconnect the DC supply harness cooling fan harness and grounding cable from the Power controller Disconnect connecting harnesses fro
51. system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 108 Error 24 Deviation High Error 25 Saving Data Error 26 Emptying Tank Error 27 Low Pressure Error 28 High Pressure Oxygen Sensor Error 2 Saving Data Error 3 Deviation High Coefficient b too high NVRAM Damaged Error Emptying Tank Pressure P2 lt 15 mbar Pressure P2 gt 40 mbar NVRAM Damaged Error during calibration at 100 setting 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB 1 Replace proximal sensor 2 Perform NVRAM test
52. type B equipment per IEC 601 1 Indicates the degree of protection drip proof by the enclosure O2 inlet port label Air inlet port label Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 11 DC Input 24V 90W AC Input 100 240VAC 50 60 Hz 120VA 100V 1 4A 240V 0 5A Fuse 3 15AT O2 sensor SN To Patient From Patient Do not obstruct DC input connector AC input connector O2 sensor location Device Serial Number Gas Flow To Patient from Device Gas Flow From Patient to Device Do not obstruct port or outlet Internal Battery Compartment The INSPIRATIONTM back panel label eVent Medical Ltd 0120 GR Galway Ireland US IPX A Inspiration Ventilator System SN 2002W02XXXX CAUTION in the U S connect to an AC receptacle marked Hospital Only or Hospital Grade to ensure grounding reliability Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 12 2 6 Tools Test Equipment amp Materials Description Manufacturer Test Equipment Pneumatic Calibration Analyser Electrical Safety Tester Cuff Pressure Gauge Desktop Laptop PC Pentuim Software Download Cable Adult Tubing System Paediatric Tubing System Proximal Flow Sensor Adult Proximal Flow Sensor Infant Exhalation Cover Exhalation Membrane Test Lung High Pressure Air Supply with Adjustable Pressure Regulator High P
53. will condition the gas by removing moisture and filtering contaminants then conduct the gas onward to the blender system The components which comprise the gas inlet system are described below Gas Connection Inlet Check Valve Fig 3 3 Air O2 Inlet Assemblies 3 3 1 1 The Inspiration ventilator is supplied as standard with two DISS Diameter High Pressure Indexed Safety System high pressure fittings for connection of 02 and Connnections Air supplies On request adapters and high pressure hoses may be provided to effect connection to other international gas supply standards such as NIST non interchangeable screw thread and Air Liquide 3 3 1 2 After passing through the gas inlet each high pressure gas entering the Inlet Filters F1 F2 ventilator will pass through an inlet particle filters oxygen will pass through filter F1 and Air through filter F2 The function of the particle filter is to remove contaminants down to a size as small as 5 microns from the gas coming into the ventilator system The two filters are common components and must under go replacement at annual intervals 3 3 1 3 The inlet gases pass through the filter and are then directed against the Water Traps WT1 WT2 wall of the water trap As the gas strikes the wall of the water trap its internal pressure will be increased momentarily prompting any carried moisture to be released Ensuring that the supplied gases are clean and dry in this way will preve
54. year or as necessary Replacement of internal O2 sensor P N F910028 Replacement of gas inlet filters P N F910205 Full performance checkout as per service manual section 6 Every 2 years or as necessary Replacement of internal battery cell P N F820003 LS ST P N F810003 Original Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 14 3 Theory Of Operation 3 1 Introduction 3 2 Overview Of Inspiration Operation This section has been provided to detail the operational theory of the Inspiration ventilator system The section begins with an overview of the ventilator operation and goes on to discuss in great detail the operational principals of both the pneumatic and electronic systems component by component Finally the section goes on to describe the operation of the ventilators firmware in interfacing and controlling the two systems The Inspiration ventilator system consists of two major systems the pneumatic system and the electronic system which combine under software control to deliver respiratory support at operator determined parameters The pneumatics under the control of the microprocessor supply air and oxygen to the patient system external to the device The electronic system inputs and supervises the power sources to the unit and provides electronic control of the ventilators components High Pressure air and oxygen enter the unit from an external source via two DISS Diameter
55. 0 01 2004 106 Error 16 Deviation High Error 17 Deviation High Error 18 Deviation High Error 19 Deviation High Differential pressure too low 30 Ipm Differential pressure between Adult Infant limits O 30 lpm Differential pressure too high 30 lpm Differential pressure too low low flow level 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB 1 Ensure that system is leak free by running system test 2
56. 2 0 01 2004 27 3 3 4 2 Safety Valve SV A safety valve is incorporated into the safety valve block in order to provide the patient with an open breathing path to and from ambient in emergency situations In normal operation the valve will be closed by energising a normally open solenoid With this solenoid energised its plunger will press the safety valve seat hard upon a sealing surface closing of the ambient port In the event of an error condition the solenoid is de energised removing the plunger from the seat With the plunger removed the seat will remain loosely in position on the sealing surface In this condition any inspiratory effort on the part of the patient will result in the seat being displaced and in inspiratory flow being drawn through this path from ambient As the patient begins to exhale the seat will fall against the sealing surface and closing off the path once more In this condition the patient will be able to exhale through the now open exhalation system Safety Valve Solenoid Safety Valve Plunger D Safety Valve Seat Fig 3 17 Safety Valve Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 28 3 3 5 Proximal Measurements 3 3 5 1 Proximal Flow Sensor FS3 dP3 A flow sensor may be used proximally to provide the operator with feedback on the patient s exhaled tidal volume and proximal airway pressures Additionally use of the proximal flow sensor will per
57. 3 3 6 Exhalation System 3 3 6 1 Exhalation Proportional Valve PV2 The exhalation system functions to seal the patient circuit during the Inspiration and to open the patient circuit as required to maintain the operator set PEEP baseline pressure during the exhalation Fig 3 20 Exhalation System The expiratory proportional valve PV2 may be cycled through steps 1 1000 by varying the controlling pulse width modulated PWM signal applied to it As the controlling PWM is increased the downward closing force of the plunger within the exhalation valve will be increased this will allow the EV to retain a greater amount of pressure within the tubing system As the controlling PWM is decreased the downward closing force of the plunger will be decreased The plunger will act upon the exhalation membrane and cover in order to seal the tubing system The operation of the valve will be microprocessor regulated using feedback from the internal pressure transducer P2 Fig 3 21 Exhalation Hubmagnet Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 31 3 3 6 2 The exhalation compartment comprises of cover and diaphragm which will Exhalation act to seal the patient system Compartment i The exhalation cover provides the seating for the exhalation diaphragm and includes exhaust ports to provide minimal expiratory resistance The cover is re usable and is rated for around 100 autoclave cycles
58. 8 s 90 938 94 95 96 a a AA EEE 1 102 103 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 vi THIS PAGE INTENTIONALLY LEFT BLANK Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 vii THIS PAGE INTENTIONALLY LEFT BLANK Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 viii Field Service Record Appendix C For your convenience and use you will find on the following pages a Field Service Record Customer complaint form You should use and complete this document whenever possible when performing any procedures on the Inspiration Ventilator system In the event of performing repairs or upgrades to any device you are kindly requested to forward a completed copy to eVent Medical at fax number provided for our information In the event of any failure to the device this document should completed and sent to eVent Medical to allow us to promptly process your customer complaint and warranty claim if applicable accordingly Completed field service record customer complaint forms should be forwarded as appropriate to one of the following locations Worldwide eVent Medical Ltd 6A Liosban Business Park Tuam Road Galway Ireland Phone 353 91 764472 Fax 353 91 764379 trevor event medical com service event medical com United States eVent Medical Ltd 5950 Priestly Drive Carlsbad CA
59. Board F 920067 Pneumatic Valve Harness LS ST only F 910067 Pneumatic Valve Harness original only Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 159 10 9 Pneumatic Lower Module 10 9 1 PNEUMATIC LOWER MODULE emo ario espias e sm ang pate OO 08 F71009 Inner ring exhalation inner se Feo Swemimertn OOS Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 160 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 161 10 10 Pneumatic Upper Block 10 10 1 PNEUMATIC UPPER BLOCK mo Ferito O Gesso e Foe stan cover e Fece Fix epecementnie DO ooe Repicemen Bow Wer Tap Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 162 F 810042 O ring inlet check valve F 810061 Inlet check valve F 810037 O ring connection block F 810032 O ring blocks large Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 163 10 11 Sensor Block 1 10 11 1 SENSOR BLOCK 1 F 910081 Internal Flow Sensor F 810034 O ring internal flow sensor o 066 F 810039 Screw internal flow sensor Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 164 10 12 SENSOR BLOCK 2 10 12 1 SENSOR BLOCK 2 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 165 F 920100 Compressor Bl
60. C input Internal battery operating time with fully charged battery Os and air supply pressure range Internal compressor Earth leakage current Enclosure Leakage current 2 5 2 Settings Ventilation modes Apnea backup Special functions 100 to 240 VAC 50 60 Hz 120 VA W 24 VDC 10 gt 120 minutes without compressor 120 minutes with compressor at 8 0 lpm MV peak flow of 45 lpm PEEP of 5 cm H20 average peak pressure of 32 cm H20 and a mean pressure of 7 cmH20 29 86 psi 2 to 6 bar 20 Ipm Minute Volume O 14 7 psi 1 bar lt 300 pA lt 50 uA Volume based synchronized mandatory ventilation V CMV Volume based synchronized intermittent mandatory ventilation V SIMV Pressure regulated volume control synchronised mandatory ventilation PRVC CMV a Volume Target Ventilation VTV mode Pressure regulated volume control synchronised intermittent mandatory ventilation PRVC SIMV a Volume Target Ventilation VTV mode Pressure based synchronized mandatory ventilation CMV Pressure based synchronized intermittent mandatory Ventilation P SIMV Spontaneous Ventilation SPONT Pressure Support PSV Volume Support VS a Volume Target Ventilation VTV mode Smart Positive Airway Pressure SPAP Select back up from V CMV V SIMV P CMV P SIMV Smart Nebulizer Smart Sigh 100 Oxygen Manual Inspiration Inspiratory and expiratory Hold functions Inspira
61. CB to be determined without need for physical inspection Jumper This function allows the engineer to identify whether the selected PCB has any jumpers present without the need for physical inspection Versions Allows the revisions for system and power software plus the hardware revisions of the three primary PCB s to be determined without the need for physical inspection Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 70 5 3 4 Screen 4 Fab Test 4 Fig 5 5 allows the trained service technician to Screen 4 Power view data and values pertaining to the Power PCB power processor and Interface Controller related areas PIC FabTest4 Power controller Pic Power supply Nof brownouts U line B BU U batteries 24 5U Accu Clear U external 1 4 U Batt Switch In Line Speaker state Ok Battery 2x12U Control Batt status Off Ok Capacity 5646 mAh 98 576 mAh 100 Communication Status Master switch Packages sent 255 Pic errors 0 alive On Mc cmd ack err 0 Mc cheksum err 0 Miscellaneous I main Mc 240 631mA Pic Alarm not active SW version Pic SUNS Versions compatible No Off request DEE LL Not OFF Prev Next Fig 5 5 Technical Screen 4 Power Supply This area of screen 6 will permit the service engineer to review the current power supply status Measured values are available for the following e Vline power supply voltage derived from line voltage e
62. DC Supply is switched on and harness connected 2 Check internal DC harness amp connections to External supply connector 3 Replace Power PCB Fab Test 5 Zero Error P1 DP1 Unable to zero pressure 1 Ensure that all pressure is removed transducer from reservoir 2 Attempt re zero once more 3 Replace Power PCB Zero Error P2 DP2 Unable to zero pressure 1 Ensure that all pressure is removed P3 DP3 02 transducer from system 2 Ensure that patient system amp proximal sensor are not connected 3 Attempt re zero once more 4 Replace Sensor PCB Fab Test 6 No Relevant Errors N A N A Fab Test 7 No flow on PF300 No flow measured on test flow 1 Ensure that tubing is securely meter connected 2 Power cycle test flow meter and ensure that it is zeroed 2 Verfiy electrical connections to PV1 3 Replace PV1 Valve 4 Replace Power PCB Gain Errors High Low Gain error during internal flow 1 Rezero transducer DP2 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 84 sensor calibration 2 Ensure that measured flow is within tolerance 3 Replace internal flow sensor 4 Replace sensor PCB Fab Test 8 No Relevant Errors N A N A Fab Test 9 Error Pressure Drop Pressure drop out of range during calibration step Error Pressure Rise Pressure risen out of range during calibration step 1 Ensure that supply to device is stable and holding at required level
63. Figure 3 MISCA Response Note The MISCA command response is designed to be compatible with the MISCA command response from Puritan Bennett Ventilators including the 7200 700 series and 800 series In the fields where the command response differs from that of the Puritan Bennett ventilators the difference is noted in the field description Field Content 1 MISCA 5 characters Se 3 characters the number of bytes between lt STX gt and lt ETX gt 2 characters the number of fields between lt STX gt and lt ETX gt E ote 13 characte 7 Notused 6characters o oS 8 Notused 12 characters o 9 Mode setting 6 characters S O 10 Respiratory rate setting 6 characters 41 Tidal volume setting 6 characters 12 Peak flow setting 6 characters 13 02 setting 6 characters 14 Notused 6 characters o O 15 PEEP CPAP setting 6 characters 16 Plateau time 6 characters o o oo 17 Notused 6 characters S 18 Notused 6 character Z oZ o O Endoftramemission of transmission Data field left Te E and padded with spaces Start in nni data transmission character Start of data transmission character 02 hex hex raros of data fields between lt STX gt and lt ETX gt Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 19 Not used 6 characters Nebulizer setting On or Off 6 characters 30 100 O2
64. GM Medical Lia Inspiration Series Ventilator Technical Manual Inspiration Series Ventilator Model Numbers F7300000 XX F7200000 XX F7100000 XX Technical Manual eVent Medical Limited 6A Liosban Business Park Tuam Road Galway Ireland Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 Contents 1 reface Copyright Information Definitions Product Warranty Manufacturer Electromagnetic Susceptibility Customer Assistance P 1 1 1 2 1 3 1 4 Year Of Manufacture 1 5 1 6 1 7 General Information 2 1 Introduction 2 2 How To Use The Manual 2 3 Safety Information 2 4 Product Description 2 5 Product Specification 2 5 1 Power And Gas Supplies 2 5 2 Settings 2 5 3 Monitoring Patient Values 2 5 4 Alarms 2 5 5 Physical Data 2 5 6 Environmental Data 2 5 7 Technical Data 2 5 8 Compliance And Approvals 2 6 Device Labels And Symbols 2 7 Tools And Test Equipment 2 8 Preventive Maintenance Parts 3 Theory Of Operation 3 1 Introduction 3 2 Overview Of Inspiration Theory Of Operation 3 3 Pneumatic Theory Of Operation 3 3 1 Gas Inlet System 3 3 1 1 High Pressure Connections 3 3 1 2 Inlet Filters F1 F2 3 3 1 3 Inlet Water Traps WT1 WT2 3 3 1 4 Inlet Check Valves CV1 CV2 3 3 2 Gas Blending System 3 3 2 1 Gas Supply Valves SV1 SV2 3 3 2 2 Blender Flow Sensor FS1 dP1 3 3 2 3 Compressor System 3 3 2 4 Compressor Unloading Valve 3 3 2 5 Inspiration Reservoir
65. LS ST the internal battery cells are rated at 7 5 ah in this Original Inspiration models these are rated at 3 2ah The batteries are not interchangeable between devices Caution The internal battery pack should always be connected up as per the label provided on inside of the internal battery cover Fig 3 28 Internal Battery Pack LS ST To supplement the AC supply and the Internal battery back users have the option of an external battery supply An external DC connector is provided on the ventilators rear panel to allow connection of an external 24 VDC battery pack eVent Medical recommends the use of its external battery assembly available as Part no F 710520 Fig 3 29 External DC Connector Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 40 3 4 5 Power PCB The Power PCB is located within the ventilators pneumatic compartment There are two possible configurations for the Power PCB dependant upon the model Inspiration LS ST uses Power PCB rev 04 and above shown in diagram below Original Inspiration model uses Power PCB rev 03 and below The critical functions for each of the PCB versions are largely the same and are described as follows Fig 3 30 Power PCB Power Software Storage Resident on the Power PCB rev 04 and up is a flash EPROM which is used for storage of power system software This software may be updated as required through the communication port adjacent to the
66. The delivered tidal volume is being Limited limited by the current VTV and or alarm settings 7 3 4 General Operation Errors Medium Priority Error No 70 Alarm Check Flow Sensor The measuring tubes for the external flow Tubing sensor have either come loose or are blocked Error No 71 Alarm Check Flow Sensor The external flow sensor tubing is loose of may have been attached incorrectly Error No 72 Alarm Air Supply The air supply is interrupted and compressor backup is switched off in the configuration menu Error No 73 Alarm Oxygen Supply The O2 supply is not available Error No 74 Alarm Compressor Internal compressor system has failed or is disabled Error No 75 Not Used Not used Error No 76 Not Used Not Used Error No 77 Alarm High Frequency Respiratory rate is too high compared with the High Rate alarm limit Error No 78 Alarm Low Frequency Respiratory rate is too low compared with the low rate alarm limit Error No 79 Not Used Not Used Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 111 Error No 80 Error No 81 Error No 82 Error No 83 Error No 84 Error No 85 Error No 86 Error No 87 Error No 88 Error No 110 Error No 111 Error No 112 Error No 113 Error No 114 Error No 115 Error No 116 Error No 117 Alarm Check Pcontrol Pmax Alarm Check Psupport Pmax Not Used Alarm Battery Low Alarm
67. abpm LT Yes O TidalVolume ___ _ soome o Os o UN q Tidal Volume Exhaled Vie soom 90m ves No gt C Respiratory Rate 25bpms 25pm __ Mes ET No Inspiration Series Technical Manual F SVSMAN Revision 01 01 2004 ii Tidal Volume Smam T_T DE Tidal Volume Exhaled Vie 600m 120m Oves Respiratory Rae sbpm fisbm __ Ue gt C TidalVolume o oomoo o Ves Tidal Volume Exhaled Vie t000m 200m Yes C RespiratoryRate fobpm ribm O Wes gt Pressure Accwracy Tests J Omt f Rest Pass VIN a EA AA I I NI BEEP Gema Sms os UV Tine PEEP 80cmH20 300mH20 7 30mH20 __ Ue UNO L PEEP 50cmH20 S0cmH20 ScmH20 Ue Omo Oxygen Date Testi i o Feito Pes WIN Oxygen 30 Analyzer 30 3 Oxygen 30 Vent 30 3 Oxygen 60 Analyzer 60 3 Oxygen 60 Vent 60 3 Oxygen 90 Analyzer 90 3 Oxygen 90 Vent 90 3 Do Os _ UNo A E DI Pass YIN Disconnect Alarm Alarm Silence On E re Alarm Silence OFF DD fo Re ANOS i Alarm Silence Time 120 sec 12 Do Disconnect Alarm Do Resto o oC HIP Alarm On VO o es To NS Alarm Reset E jo are ne Apnea Alarm On fio le ren Apnea Ventilation 50 li e no Test Completion Record Service Representative Date Inspiration Series Technical Manual F SVSMAN Revision 01 01 2004 iii
68. acklight Inverter A backlight inverter is incorporated into the Controller PCB rev 03 and below The inverter will be used to drive the backlight on the Original Inspiration only LS and ST devices incorporate a separate backlight inverter PCB for this purpose 3 4 8 The Processor PCB provides overall control of ventilator operations and Processor PCB breath delivery It incorporates the following circuits and interfaces Front Panel Interface Reads the outputs from the front panel rotary control knob assembly and senses operation of the front panel keys Display Interface Permits the processor to interface with the LCD driver PCB in order to control flat panel LCD display data AD DC Converters Provides 16 channels of A D and D A conversion as required to interface the microprocessor with associated analog circuits and components Ventilation Control The controller PCB will interface with the Power PCB to control all aspects of ventilation Will also receive feedback signals from the pressure transducers for proportional valve control blender control patient data display and alarm decisions Alarm Control Based upon transducer feedback will make alarm decisions and signal the audible and visual alarms Pneumatic Safety Switch As with the Power PCB in the event of a technical error the pneumatic safety switch will allow all power to be removed from the ventilators pneumatics in a single operation Power Pr
69. al intemal P 2 v Battery 1 1 POWER SUPPLY o PNELMATIC CHASSIS All Re XT xsf x22 07 Ta 02 Sensor POWER PCB SENSOR PCB EXE To xa Power PCB A To Keypad DO INSPIRATION SERIES WIRING DIAGRAM Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 172 10 17 Ventilator Wiring emo Parto osso O Mains input cable Original only Mains input cable LS ST only Power supply cable Original only Power supply cable LS ST only 0 ooe ETE TS Pneumatic chassis harness Original only 08 F920067 Pneumatic chassis harness LS ST only e FS20080 convolerseboncase Inverter cable ST only Inverter cable LS only Earth Cable PU front LS only Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 173 10 18 Ventilator Packaging 10 18 1 Inspiration LS Packaging emo Ferie Dep T oso Packaging FRU LS nous rt 0102 0004 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 174 10 18 2 Inspiration ST Original Packaging teme Fante Desp rosas Packing FRU ST new e 1 02 0308 F 920506 Device Bag LS Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 175 THIS PAGE INTENTIONALLY LEFT BLANK Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 176 System Software Installation Appen
70. alarms during the performance verification e Use the alarm silence key as required during the performance verification to mute any alarms should they occur e Except for the alarm silence key do not change the control settings during these procedures unless specifically instructed e Refer to section 9 of this manual for service and repair information and section 10 for identification of repair parts When repairs have been completed repeat the test When the test successful proceed with the next test Note The following procedures do not verify the performance of accessories Verify the performance of accessories using the appropriate procedures in the applicable operators or service manual The electrical safety test verifies that ground resistance and earth leakage current are within safe limits Perform this test whenever you service the ventilator per your hospitals requirements With the device switched off plug unit under test UUT mains cable in the electrical safety tester With cable clip connected to a suitable point on the ventilator chassis perform ground resistance test using appropriate function on electrical safety tester Ground resistance should be lt 0 20 Switch on the device and allow power on self test to pass Using appropriate function on electrical safety tester perform leakage current test for forward and reverse polarity Earth leakage current values in each case should be lt 300 pA all units
71. ank JP units only F 910021 Compressor Unloading Valve F 910200 Muffler Unloading Valve F 920101 Blanking Seal JP units only F 920102 Blanking Screw JP units only Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 166 10 13 Safety Valve Block 10 13 1 SAFETY VALVE BLOCK Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 167 10 14 Front Pneumatic Module 10 14 1 FRONT PNEUMATIC MODULE F 810005 Mounting Screws F 910239 Front Block Module FRU F 810037 Nebulizer Connector O Ring F 710329 Nebulizer Block O Ring F 910026 Nebulizer Solenoid SV4 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 168 10 15 Blender Module 10 15 1 BLENDER MODULE Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 169 10 16 Compressor Module 10 16 1 COMPRESSOR MODULE INSPIRATION LS ST emma Ferite Deseo De aos Compressor Moue rae E aos compresso Supporto De Feon Screw compresso Mem Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 170 10 16 2 COMPRESSOR MODULE INSPIRATION ORIGINAL teme Ferie DO Feo Gompessortess se Fece GompessorAssemty e06 se esmo Power Suoy Assembly Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 171 Etemal DC 1 1 2 2 Fan Mains Ground 2 D
72. anual Repairs or any work performed on the device should be recorded on this sheet or similar and retained for future reference For maintenance of the patient system and accessory items consult the Inspiration ventilator system operators instructions and refer to the applicable accessory manuals Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 124 9 16 Service And Repair Procedures 9 16 1 Ventilator Stand Removal Installation 9 16 2 Front Housing Module Removal Installation 9 16 3 Removal Of PU Front Bezel LS Only To remove the ventilator from its stand assembly use the following procedure Installation should be completed by reversal of the removal procedure Ensure that the brakes have been engaged to the casters on the base of the stand Ensure that all accessory items tubing system gas supply hoses and electrical source cables have been removed from the ventilator While supporting the ventilator using a 5mm hex driver remove the four M5 screws and flat washers securing the ventilator head to the stand mounting plate Lift the ventilator head off of the stand and place on a secure flat surface To remove the top cover enclosure from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Ensure that the ventilator is positioned on a secure flat surface If the ventilator is secured to its stand ens
73. arameters are appropriately set 2 Observe monitored data and ensure that monitored respiratory rate is 0 1 Verify the ventilator settings Ensure that apnea back up is set to On 2 Observe monitored data and ensure that monitored respiratory rate is 0 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 102 7 Diagnostic Error Codes 7 1 Introduction This section of the manual has been devised to allow the trained service technician to interpret the diagnostic codes contained within the devices error log 7 2 About Diagnostic ln the event of a hardware or software error being detected which would Codes compromise safe breath delivery the operator will be confronted with an alarm message in the following form TF XY Where TF Technical Fault XY the specific error number In the event of a technical fault being detected power will be immediately removed from the devices pneumatic system de energising all valves and putting the device into Safety Valve mode ref sec 3 for description The unit will remain in ambient breathing mode until the triggering fault condition has been corrected and the unit has been tested When investigating any error condition it is advisable to review the full technical error log Fab Test 11 in order to establish if there are any contributory problems and whether there is a history of the reported problem When viewed in the Fab Test 11 error l
74. ate 9600 Data Bits 8 Stop Bits 1 Parity OFF Flow Control OFF Serial RS 232 port commands The communications port responds to these commands facilitating communication to and from the ventilator using the serial ports e RSET clears the data from the ventilator s receive buffer SNDA tells the ventilator to send ventilator settings and monitored data to the host system RSET clear ventilator buffer Enter the RSET command exactly like this RSET lt CR gt e Where lt CR gt is a carriage return The ventilator only responds if it receives a carriage return When the ventilator receives the RSET command it clears its receive buffer The ventilator does not send a response to the host system SNDA send ventilator settings and data Enter the SNDA command exactly like this SNDA lt CR gt Where lt CR gt is a carriage return The ventilator responds only if it receives a carriage return When the ventilator receives the SNDA command it responds with a code MISCA followed by the ventilator settings and monitored data information The MISCA response follows the format shown in Figure 3 below Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 iii MISCA 708 87 lt ST gt Fleldi Filoz EMG lt 0R gt 706 97 lt STX gt Field1 Field2 lt ETX gt lt CR gt fi o E of Number of bytes between lt STX gt and lt ETX gt between lt STX gt and lt ETX gt e code to SNDA command
75. ce software connect the opposite end of the software download cable to the Ethernet port on the ventilators rear panel CAUTION As defined above ensure that the software download cable is attached to the correct rear panel port for the software to be installed In correct connection will result in corruption of NVRAM calibration data Na Figure 1 Download Cable Connection e With connections secure double click the download exe icon located on your desktop previously installed in order to start the download process and follow the on screen instructions On the download start up screen select Next to proceed and the firmware selection screen shown in figure 2 will appear At the firmware selection screen choose select file and a further window will appear listing the software files available locally on your PC Select the appropriate file for the software to requiring installation Software files available are broken down as follows Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 iv o Main System Software eVentVX X X tim o Mini Web System Software eVentMWIVX X X tim o Mini Web Applet Software eVentWebAppletV X X X tim e Ensure that correct file and extension is now listed on the main screen then select Next to proceed to next step ET TE ET IMT Information Managoment Technology AG Welcome to th Fiteware Domenico LIMIT U Nake chase tha you have t
76. charge always ensure that appropriate ESD guidelines are followed when performing service to the equipment Use only recommended tools test equipment and service materials when servicing the ventilator When performing service take precautions to prevent dirt and other Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 121 9 4 Cleaning 9 5 Electrical Cables And Pneumatic Connection 9 6 ESD Control 9 7 General Information 9 8 Procedures And Precautions particles from entering the ventilator interior particularly the pneumatic manifold assemblies Inspect any removed parts including those removed to gain access to a suspected faulty component Inspect and clean the exposed area behind removed parts as required Clean removed parts to facilitate further inspection Investigate and determine the cause of any detected abnormality Repair the unit or consult your local eVENT technical support location for assistance on unsolved problems Replace or repair any parts which are found to be worn missing damaged cracked or otherwise show signs of any physical abnormalities If needed follow these general cleaning guidelines when cleaning the ventilator during servicing Procedures for periodic cleaning and sterilisation of the ventilator and accessories is listed in the INSPIRATION ventilator system operators instructions Specific procedures for periodic cleaning and inspection done during t
77. cifications were established with the test equipment as specified in table 6 3 If the accuracy of your institutions test equipment differ from those listed please make allowances Note The procedures in this section do not apply to ventilator accessories Refer to operators or service manuals of the accessories Malfunctioning accessories may affect some ventilator functions and may result in false test results The field verification test and fabrication tests or parts there of should be run periodically or after a service has been performed as defined in the table below Interval Or Service Performed Test Steps Required All Tests All Tests Annually Following annual preventive maintenance Processor PCB replacement System Software Installation All Operation Tests 6 6 3 Fab Tests 3 5 7 9 13 All Operation Tests 6 6 3 Controller PCB replacement Graphic PCB replacement VGA Display replacement Sensor PCB replacement Power PCB replacement Power Supply replacement All Operation Tests 6 6 3 All Operation Tests 6 6 3 Fab Tests 5 All Operation Tests 6 6 3 Power Software Installation Electrical Safety Tests Fab Tests 4 5 All Operation Tests 6 6 3 Electrical Safety Tests Fab Test 4 All Operation Tests 6 6 3 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 87 6 4 Test Equipment And Service Materials Internal Battery replacement Fab Test 4
78. creen is as follows FabTestii Diagnose Running hours Total i Sh joo Running hours Compressor h ClearLog 1 00 06 87 01 2061 Error 48 2 18 09 03 01 2001 Error 43 3 18 08 03 01 2001 Error 43 4 18 08 03 01 2001 Error 43 5 18 08 03 01 2001 Error 43 18 07 03 01 2001 Error 110 vi 18 07 03 01 2001 Error 117 8 18 06 63 01 2061 Error 43 3 16 05 03 01 2001 Error 74 10 18 65 03 01 2001 Error 73 Preu Nex t Fig 5 12 Technical Screen 11 Running hours Total This function will allow the service engineer to determine the total elapsed running hours of the Inspiration system Total running hours should be consulted when determining requirements for preventive maintenance and should be recorded on the service report whenever work is performed Running Hours Comp This function will allow the service engineer to determine the total running hours of the integral compressor system Compressor hours should be recorded on the service report whenever work is performed Error Logs Selecting the Log Nr function will permit the service engineer to scroll through the ventilators error log This log will store up to 229 events including technical errors high priority and medium priority alarms Technical errors will be highlighted with an asterix following the alarm number By turning the rotary control knob the engineer may view the entire contents of the log Errors will appear in the following form A BB BB
79. culate average for the delivered tidal volume Ensure that tidal volume is 1000ml 200ml Record result on the final test record Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 94 Observe and record the reading for respiratory breath rate Reading should be 10bpm 1 0bpm Record result on the final test record Switch UUT screen to show Monitoring ensure that Vte reading is 1000ml 200ml Record result on the final test record Operational Test 3 Pressure Accuracy Pcontrol PEEP Sigh Adjust the ventilator settings as follows Respiratory Rate 15 bpm _risetime Sou Allow a minimum of 10 breaths for the device to stabilise at the current ventilation settings On the PF300 numerical screen 1 record the measured value of peak pressure for 5 consecutive breaths then calculate average Ensure that peak pressure is 10cmH20 1 Record result on the final test record Switch UUT screen to show Monitoring ensure that devices Ppeak reading is 10cmH20 1 Record result on the final test record On completion make the following changes to ventilator settings PEEP 0 cmH20 Alarms Adjust As Required Allow a minimum of 10 breaths for the device to stabilise at the current ventilation settings Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 95 On the PF300 numerical screen 1 record the measured value of peak pressure for 5 consecutive br
80. device which when installed Mini Web Interface PCB expands the communication capabilities of the Inspiration ventilator system The mini web PCB provides the user with a low cost monitoring system The mini web will allow the connection of a number of Inspiration ventilator systems to a local network for monitoring by a central station or alternatively connection to a standalone monitor All forms of ventilator data settings patient data waveforms alarms are accessible for monitoring but not for adjustment through this media Additionally the mini web PCB opens up new possibilities in the area of servicing Using the mini web PCB it is possible to remotely connect to the Inspiration over the internet to access its diagnostic functions eg service data statistics diagnostic logs alarm logs Fig 3 36 Mini Web Interface PCB 3 4 14 The Inverter PCB is an additional component included in the LS ST Inverter PCB Inspiration models only The Inverter PCB has a single 12VDC input from LS ST Only the Motherboard PCB The Inverter PCB outputs dual supplies as required to drive the backlight on ST and LS Models The Inverter PCB s for LS and ST models differ only in the positions of their output connections Fig 3 37 Inverter PCB Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 47 3 4 15 The DC DC Converter PCB is used solely on the Inspiration LS model DC DC Converter PCB The DC DC Converter
81. dix A For convenience a full copy of the Software Installation Instructions for the Inspiration ventilator system has been included on the following pages This detailed procedure should be followed exactly when installing each new version of system or mini web application software Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 UM ccica Ltd Inspiration ventilator system Software Installation Instructions Definition of statements Statements preceded by the following are of special significance WARNING Means that there is a possibility of injury to yourself or other persons CAUTION Means that there is a possibility of damage to the equipment or other property NOTE Indicates a point of particular interest or special emphasis for more efficient and convenient operation of the equipment Description These instructions describe in detail how to successfully install new main system and mini web interface software to the Inspiration Ventilator system WARNING In order to ensure proper operation and avoid the possibility of physical injury only qualified personnel should attempt to service perform installations or make other authorised modifications to the ventilator The user of this product shall retain sole responsibility for any ventilator malfunction due to operation or maintenance performed by persons not trained by the manufacturer Suggested Tools and Equipment Table 1
82. e 2 x CSK screws securing the pneumatic chassis to either side of the bottom housing Carefully lift the complete pneumatic chassis out of the bottom housing and place on a secure surface To remove the Blender System from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove the top cover enclosure 9 16 2 Remove the compressor platform 9 16 13 Remove the Power PCB 9 16 17 Disconnect the main pneumatic harness from the gas supply valves SVI and SV2 Using hex driver remove 4 x cap head screw securing the blender system to the upper pneumatic chassis To remove either blender valve from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Note Observe and note the orientation of blender valves prior to removal Valve body must be oriented such that number stamped surface faces front of the device Remove the top cover enclosure 9 16 2 Remove the compressor platform 9 16 13 Remove the Power PCB 9 16 17 Disconnect the main pneumatic harness from the gas supply valves SVI and SV2 Using hex driver remove 4 x cap head screw securing the blender system to the upper pneumatic chassis Using a 14mm open end wrench remove the nut securing the hub magnet of valve SV1 2 to the valve body lift hub magnet off and set aside Using a T20 torx driver remove 2 x CSK scre
83. e INSPIRATION will start the failure compressor Mixture will only contain compressor Alarm Medium air Oxygen supply No gas activated No pneumatic source available to the device Alarm High Internal Pressure Low Alarm Medium Oxygen supply Air supply Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 24 3 3 3 During breath delivery all breath parameters with the exception of FiO2 Gas Delivery are controlled by the inspiratory proportional valve PV1 This valve is microprocessor controlled using feedback from the internal flow sensor System FS2 dP2 and internal pressure sensor P2 situated at its output Gas passing through the valve will pass into the patient circuit D Fig 3 12 Gas Delivery System 3 3 3 1 The delivery proportional valve PV1 may be cycled through steps 1 Delivery Proportional 500 by varying the controlling pulse width modulated PWM signal Valve PV1 applied to it As the controlling PWM is increased PV1 will open further allowing more flow through it As the controlling PWM is decreased PV1 will begin to close resulting in less flow being permitted to pass through The operation of the valve will be microprocessor regulated using feedback from the breath delivery transducers Fig 3 13 Proportional Valve PV1 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 25 3 3 3 2 Internal Flow Sensor FS2 DP2 3 3 3 3
84. eak or disconnect The apnea interval has elapsed without a patient triggered or mandatory breath being delivered Is active in V SIMV P SIMV and Spontaneous modes Exhaled minute volume is too low compared with the set alarm limit for ExpMinVol Exhaled minute volume is too high compared with the set alarm limit for ExpMinVol Inspiratory O2 concentration is too low Possible causes gas mixing system error O2 cell f aulty monitor value too low compared with the control value 02 sensor calibration should be performed Inspiratory O2 concentration is too high Possible causes gas mixing system error O2 cell faulty monitor value too low compared with the control value O2 sensor calibration should be performed Nebulizer flow too high The nebulizer tubing has become disconnected from the ventilator or nebulizer vial Exhaled minute volume is too low compared with the set alarm limit for Vte Exhaled tidal volume is too high compared with the set alarm limit for Vte Ventilator Response Device switches to ambient ventilation mode Ventilation continues with Inspiration valve closed Ventilator immediately switches to exhalation for 1 second without PEEP Ventilation continues but pressure is limited at the alarm setting Ventilation Continues nebulizer is switched off Ventilation Continues Device will look for patients next inspiratory effort Note If apnea back up is switc
85. ear from the time of sale To ensure the validity of the warranty detailed maintenance records should be retained for each device Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 1 1 5 Year Of Manufacture 1 6 Manufacturer 1 7 Electromagnetic Susceptibility 1 8 Customer Assistance The Inspiration series ventilator systems year of manufacture may be determined from the device serial number as displayed on the rear panel type label in the following form LS ST Device Serial No XXXX W YYZZZZ Where the digits XXXX report the year of manufacture W denotes eVent manufacturing facility YY reports model type and digits ZZZZ are a sequential but individual number Original Device Serial No XXXX YYYY Where the digits XXXX report a sequential serial number and digits YYYY report the year of manufacture eVent Medical Limited 6A Liosban Business Park Tuam Road Galway Ireland The Inspiration series ventilator system complies with the requirements of IEC 601 1 2 EMC Collateral Standard including E field susceptibility requirements at a level of 10 volts per meter at frequencies from 26 Mhz 2 5 Ghz and the ESD requirements of this standard It should be noted however that even at this level of device immunity certain transmitting devices cellular phones cordless phones paging transmitters eg emit radio frequencies that could interrupt ventilator operation if located i
86. eaths then calculate average Ensure that peak pressure is 50cmH20 5 Record result on the final test record Switch UUT screen to show Monitoring ensure that devices Ppeak reading is 50cmH20 5 Record result on the final test record On completion make the following changes to ventilator settings Respiratory Rate Allow a minimum of 10 breaths for the device to stabilise at the current ventilation settings On the PF300 numerical screen 1 record the measured value of PEEP Ensure that PEEP is 5cmH20 0 5 Record result on the final test record Switch UUT screen to show Monitoring ensure that devices PEEP reading is 5cmH20 1 Record result on the final test record On completion make the following changes to ventilator settings ee TV Adjust As Required Allow a minimum of 10 breaths for the device to stabilise at the current ventilation settings On the PF300 numerical screen 1 record the measured value of PEEP Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 96 Ensure that PEEP is 30cmH20 3 Record result on the final test record Switch UUT screen to show Monitoring ensure that devices PEEP reading is 30cmH20 3 Record result on the final test record On completion make the following changes to ventilator settings ee O ow Allow a minimum of 10 breaths for the device to stabilise at the current ventilation settings On the PF300 numerical
87. echnical Manual F SVSMAN Revision 2 0 01 2004 62 4 4 2 Configuration Screen 1 Ver s ons Lodo AVN o Y Fig 4 5 Code Entry Screen Configuration screen 1 will permit the operator to configure attributes specific to how the ventilator will operate and be monitored during normal operation The attributes which may be configured are as follows Proximal Flow Sensor Allows the operator to switch proximal flow and pressure sensing On or Off With the proximal sensor selected On monitored patient data will be derived from the measurements taken at the proximal sensor Additionally flow triggering is available With the proximal sensor selected Off monitored patient data will be derived from measurements taken at the internal sensors In this condition Vte ExpMinVol and Rexp may not be monitored and flow triggering is not available 02 Sensor Allows the operator to switch Oxygen monitoring and associated alarms On or Off Once activated the oxygen sensor must be calibrated Compressor Backup Allows the operator to switch compressor backup On or Off as required With the compressor On in the event of an Air supply failure the compressor will automatically switch on Buzzer Allows the operator to adjust the audible alarm intensity up or down on a scale of 20 100 full volume Philosophy Allows the operator to configure the philosophy which will govern the timing of breath delivery during
88. ect sensor selection menu shown in default as P2 Valve A pull down menu will appear allowing the appropriate sensor to be selected Select As Applicable e Having selected the sensor and select Zero using the rotary control knob once this has been done zero calibration will be performed automatically When performing Oxygen sensor zero with system software of 3 2 12 and below the sensor harness must first be disconnected Software versions above this level allow the zero to be performed at 21 and without disconnection Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 73 5 3 6 Screen 6 Sensor Adjustment Values 5 3 7 Screen 7 Internal Flow Sensor Calibration Screen 6 Fab Test 6 Fig 5 7 will allow the trained service technician to view zero and gain calibration values for transducers measuring blender pressure flow internal pressure flow proximal pressure flow and for the Oxygen measurement cell Values are displayed for the following P1 Tank Internal Tank Pressure DPI Blender Blender Flow Transducer P2 Valve Internal Pressure Transducer DP2 Valve Internal Flow Transducer P3 Proximal Proximal Pressure Transducer DP3 Proximal Proximal Flow Transducer Oxygen 02 Measurement Cell FabTest6 Sensor Adjust Ualues PI Tank Zero 119 mi dP1 Blender Zero 119 mu P2 Valve Offset Zero 1247 mu Bain 25 33 mU mbar 2 Valve Offset Zero 718 mU
89. elf Tests 4 3 1 System Leak Test 4 3 2 Proximal Sensor Calibration 23 25 25 26 26 26 27 27 28 29 29 30 30 31 31 32 32 34 34 35 35 36 39 39 40 40 41 42 43 44 45 45 46 46 47 47 48 49 49 49 50 53 54 55 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 4 3 3 Oxygen Sensor Calibration 56 4 3 4 User Calibration Errors 57 4 4 Configuration Mode 62 4 4 1 Configuration Mode Entry 62 4 4 2 Configuration Screen 1 63 4 4 3 Configuration Screen 2 64 4 4 4 Configuration Screen 3 65 5 Service Menu 67 5 1 Introduction 67 5 2 Accessing And Navigating Service Menu 67 5 3 Service Mode 67 5 3 1 Fab Test 1 67 5 3 2 Fab Test 2 69 5 3 3 Fab Test 3 70 5 3 4 Fab Test 4 71 5 3 5 Fab Test 5 73 5 3 6 Fab Test 6 74 5 3 7 Fab Test 7 74 5 3 8 Fab Test 8 76 5 3 9 Fab Test 9 76 5 3 10 Fab Test 10 78 5 3 11 Fab Test 11 79 5 3 12 Fab Test 12 80 5 3 13 Fab Test 13 81 5 3 14 Service Mode Troubleshooting 83 6 Performance Verification 87 6 1 Introduction 87 6 2 Notes 87 6 3 When To Perform Tests 87 6 4 Tools And Test Equipment 88 6 5 Preparation For Testing 89 6 5 1 Cleaning and Inspection 89 6 5 2 Ventilator Set Up 89 6 5 3 Test Equipment Set Up 89 6 6 Testing Procedure 89 6 6 1 Electrical Safety tests 90 6 6 2 Fabrication Tests 90 6 6 3 Operational Tests 90 6 7 Troubleshooting 101 7 Error Codes 103 7 1 Introduction 108 7 2 About Di agnostic Codes 103 7 3 Technical Error Lis
90. en Polish F 710212 PT Lexan Screen Portuguese F 710212 RU Lexan Screen Russian F 710210 Knob Rotary control knob Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 147 F 710203 DE F 710203 ES F 710203 FR F 710203 UK F 710203 IT F710203 JP F 710203 PL F 710203 PT F 710203 RU ee Nose Cone German Nose Cone Spanish Nose Cone French Nose Cone English Nose Cone Italian Nose Cone Japanese Nose Cone Polish Nose Cone Portuguese Nose Cone Russian Screw Nose Cone Front Housing includes ref 01 02 Bracket Graphic Module Screw Graphic Module Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 148 10 6 GRAPHIC MODULE Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 149 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 150 10 6 2 GRAPHIC MODULE INSPIRATION ST ento Fee esco C o om E ET DO ooo sana OF cromer OO 00 AI ETC Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 151 F 920069 Display LCD Cable Not Shown F 920070 Inverter Cable Not Shown F 9201 05 Backlight Assembly Not Shown F 820025 Clip Ferrite Not Shown F 810016 Screw Graphic Module Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 152 10 6 3 GRAPHIC MODULE INSPIRATION ORIGINAL ento omo Geseniion T r
91. ent additional damage Close and seal the bag to ensure that the shield is effective Before repainting or touching up the ventilator smooth out the area with a fine sandpaper and make sure it is free from any grease corrosion or dust Remove the part to be painted or mask off the surrounding area to prevent over spray or spills When investigating reported problems identify the cause of the failure and repair replace the component as necessary Any failed non conforming parts should be retained until the subject device has been successfully repaired Following completion of the repair any non conforming parts should be returned to the manufacturer to allow failure analysis to be performed To arrange for return of non conforming parts contact your local dealer The dealer will request and receive a returns authorisation from the manufacturer Prior to despatch non conforming parts should be suitably packaged with a copy of any relevant service documentation enclosed The return authorisation number provided by the manufacturer should be clearly marked on all shipping documentation and on the exterior of the packaging To order correct parts identify the ventilator version and part then using section 9 Parts List identify the manufacturers part number for the item Should you find that the specific item is not available as a field replaceable unit FRU or that it is not stocked order the next higher assembly Retain the part to be re
92. er ribbon cable is seated correctly 3 Replace Sensor PCB 4 Replace Power PCB 5 Replace Processor PCB TF14 Technical Fault Difference of reference 1 Ensure Sensor ribbon cable is seated voltage OOR ADC1 2 correctly 2 Ensure Controller ribbon cable is seated correctly 3 Replace Sensor PCB 4 Replace Power PCB 5 Replace Processor PCB TF15 Technical Fault Reference Voltage on ADC1 1 Ensure Sensor ribbon cable is seated Out Of Range correctly 2 Ensure Controller ribbon cable is seated correctly 3 Replace Sensor PCB 4 Replace Power PCB 5 Replace Processor PCB TF16 Technical Fault Reference Voltage on ADC2 1 Ensure Sensor ribbon cable is seated Out of Range correctly 2 Ensure Controller ribbon cable is seated correctly 3 Replace Sensor PCB 4 Replace Power PCB 5 Replace Processor PCB TF17 Technical Fault 5v Supply Voltage Out of 1 Replace Power PCB Range TF18 Technical Fault Software Stack Corruption 1 Re install system software 2 Replace Processor PCB TF19 Technical Fault Communication with PIC 1 Verfiy security of all ribbon connectors processor dead and cabling to pneumatics 2 Reset power processer LS ST 3 Replace Power PCB 4 Replace Processor PCB 5 Replace Controller PCB TF20 Technical Fault Value of pressure sensor P 41 Perform re zero of all pressure out of range transducers 2 Replace Sensor PCB TF21 Technical Fault Value of pres
93. es of ignition away from the device An alternative source of ventilation should always be available when using the Inspiration ventilator Do not replace any accessories or other parts of the Inspiration while a patient is being ventilated Maintenance work must always be carried out in compliance with all relevant safety regulations Repairs assembly and use should only be carried out by specialist personnel Your device should be checked by trained personnel annually Insert a bacteria filter between the Inspiration outlet on the Inspiration and the patient breathing circuit to prevent any contamination of the device Do not sterilize the Inspiration Before each use check the water traps on the gas inputs for any residual water and or particles If you notice that the Inspiration is damaged in any way its life supporting function can no longer be guaranteed Stop ventilation with the defective device immediately and use an alternate form of ventilation To avoid electrical shock while servicing the ventilator be sure to disconnect the device from the power source US Federal law restricts this device to sale by or on the order of a physician Do not use the Inspiration Ventilator unless an internal battery with at least a minimal charge is installed If the Inspiration Ventilator has been stored for an extended period of time recharge the battery prior to use When the Inspiration Ventilator is connected to another de
94. essing of one lexan button to controller is secure 2 Replace lexan screen No machine response to 1 Ensure that ribbon cable from Lexan pressing of all lexan buttons to controller is secure 2 Replace Controller PCB 3 Replace Processor PCB 4 Replace lexan screen Fab Test 3 NVRAM Check Sum Bad checksum from non volatile 1 Ensure that all ribbon cables are Error memory securely located 2 Clear NVRAM amp repeat checksum 3 Replace Controller PCB Sensor PCB Bad checksum from Sensor 1 Ensure that all ribbon cables are Checksum Error PCB securely located 2 Replace Sensor PCB Controller PCB Bad checksum from Controller 1 Ensure that all ribbon cables are Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 83 Checksum Error securely located 2 Replace Controller PCB Power PCB Checksum Bad checksum from Power PCB 1 Ensure that all ribbon cables are Error secure 2 Replace Controller PCB Fab Test 4 V line Low Power Supply output low 1 Ensure mains supply connected 2 Ensure inlet fuses ok 3 Check internal wiring AC inlet to power supply to power PCB 3 Using DMM verify output from power supply If bad replace power supply 4 Replace Power PCB V Batteries low Internal Battery output low 1 Ensure battery is charged sufficiently before proceeding 2 Replace Internal battery 3 Check DC power harness 4 Replace Power PCB V External low External DC Output Low 1 Ensure
95. est 2 Replace proximal flow sensor 3 Perform calibration of proportion valve PVI 1 Replace proximal flow sensor 2 Perform calibration of proportion valve PVI 1 Replace 02 Sensor 2 Perform NVRAM test 3 Clear amp Test NVRAM recalibrate device 4 Replace controller PCB 1 Ensure O2 supply is connected and adequate flow available 2 Ensure 02 Sensor connected correctly 3 Replace 02 Sensor 4 Confirm that inlet check valves CV1 2 are correctly installed and undamaged replace as necessary 5 Replace Sensor PCB 6 Replace 02 Sensor interface block Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 60 Error 4 Deviation High Error 8 Sensor Not Available Error 9 Oxygen Not Available Error during calibration at 21 setting Oxygen sensor is not available for calibration Oxygen supply not available for calibration 1 Ensure Air supply is connected and that adequate flow is available or that internal compressor is available and running 2 Ensure O2 Sensor connected correctly 3 Replace O2 Sensor 4 Confirm that inlet check valves CV1 2 are correctly installed and undamaged replace as necessary 5 Replace Sensor PCB 6 Replace 02 Sensor interface block 1 Enter configuration screen 1 and ensure that the oxygen sensor is enabled 1 Ensure Oxygen supply is connected and that adequate flow is available 2 Confirm that inle
96. evice will prompt you to Remove Jumper remove by reversal of the installation and select OK to acknowledge completion The following values will be visible on the screen during and following completion of the calibration process e dP2 Actual Current internal temperature and mV reading at dP2 e dP8 Actual Current internal temperature and mV reading at dP3 e dP2 Sample 1 Start temperature and mV reading at dP3 e dP2 Sample 2 End temperature and mV reading at dP3 e Temperature Drift at dP2 Calculated value for drift mV per unit temperature Celsius e dP3 Sample 1 Start temperature and mV reading at dP3 e dP3 Sample 2 End temperature and mV reading at dP3 e Temperature Drift at dP3 Calculted value for drift mV per unit temperature Celcius 5 3 13 Technical Screen 13 Fig 5 14 will allow the trained service technician to Device Configuration configure enable and disable various functional attributes Fig 5 14 Service Screen 13 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 81 This screen may be used as necessary to configure the device for use following hardware and software enhancements Additionally this screen must be used following replacement of Motherboard PCB F 710510 or Control PCB F 720510 where these settings will have been return to default values The following attributes may be configured in this way e Languages Allows the
97. ft calibration should only be commenced if temperature is below 25 degrees Celsius If temperature is above this level switch device off in order to allow it to cool down The temperature drift compensation is performed as follows e Prior to commencing the temperature drift compensation remove side rails and mounting hardware from the device so that front housing is loosely fitted to device e Ensure that all patient tubing and the proximal flow sensor have been removed from the device e Using the rotary control knob knob select Start to commence the procedure e The device will prompt you to Connect Jumper At this request remove the front module to a point where the electronics is accessible Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 80 e Install a jumper to the vacant position on the top middle of the Sensor PCB and then place the front housing back in position e Using the rotary control knob knob select OK to confirm that the jumper is in position then OK once more to confirm that the front housing has been replaced e A two point calibration will not be performed by the device The device will take and store an initial cold reading and then start the internal compressor The compressor will be allowed to run for an extended period in order to elevate the devices internal temperature following which a second reading will taken and stored e On completion the d
98. g the O2 cell compartment panel to the ventilators bottom housing LS ST Devices Using a 2 5mm hex driver remove CSK screws securing the O2 battery plate from lower housing Disconnect ground cable and set aside the O2 cell compartment panel Grip the O2 cell and rotate counter clockwise to disengage from the pneumatic assembly Replace as is necessary per PM schedule To remove the internal battery assembly from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedures Remove air and O2 inlet water traps 9 16 18 Using a 2 5 mm hex driver remove 4 x CSK screws securing the battery compartment panel to the bottom housing Disconnect the battery harness noting the orientation of the connectors Replace batteries as is necessary per PM schedule To remove the complete pneumatic chassis from the ventilator system complete the following procedure Installation should be completed by reversal of the removal procedure Remove the top cover assembly 9 16 2 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 132 9 16 24 Removal Of Blending System 9 16 25 Removal Of Blender Valve Remove the compressor platform 9 16 13 Remove Gas Inlet Assemblies 9 16 18 Remove Rear Panel 9 16 20 Remove 4 x CSK screws securing the battery O02 sensor compartment cover and disconnect DC harness from the battery terminals Remove th
99. has a single 5VDC input which is converted to LS Only 3 3VDC in order to drive the 12 1 TFT display used in the LS Model Fig 3 38 DC DC Converter PCB Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 48 4 Self Test amp Configuration Screens 4 1 Introduction This section of the Inspiration Series Ventilator service manual provides the user with a detailed description of the ventilators many self testing functions and user configuration screens Some troubleshooting information directly related to these testing areas is added for convenience at each stage 4 2 Power On Self Power on selftest or POST is performed each time the ventilator is Test POST powered on in order to determine whether the device is in a fully functional condition The POST is performed after switch on whilst the pre start up screen characterised by eVent company logo and or progress bar is visible on the LCD display Fig 4 1 The following areas are verified during the running of each Power On Self Test e POST 1 External RAM 1 MB e POST 2 Internal Processor RAM 2 kB e POST 3 Correctness Of Used ROM on the Flash e POST 4 Checks safety zones of RAM eg Between stack and variables e POST 5 Checks the integrity of NVRAM data A D converter initialisation Integrity of EEPROM s Generally in the event of an error being detected during the first 4 sections of Power On Self Test the progress bar on the pre star
100. hat ventilation continues uninterrupted After an additional number of cycles verify high priority audible alarm is active and that High Oxygen alarm message is now visible in screen area Verify that ventilation continues uninterrupted Disconnect high pressure 02 sources Verify that high priority Internal Pressure Low audible and visual alarm is active in addition to Air O2 Supply alarms Breath delivery should cease Restore both high pressure gas sources and verify that alarm conditions reset Switch off device and invoke configuration menu to re enable compressor back up Operational Test 2 Volume Accuracy VOL RR VTe Continue with the ventilator configured as before with a paediatric tubing system and proximal sensor Connect the proximal sensor directly to the high flow inlet of the PF300 Place ET tube with test lung still connected to the high flow exhaust port Switch device on once more and at the start screen select Last then Next to enter the proposed settings screen Configure the ventilator as follows and on completion select activate to commence ventilation ria votume som Respiratory Rate wem Peak row om Allow a minimum of 10 breaths for the device to stabilise at the current ventilation settings On the PF300 numerical screen 1 record the measured volume for 5 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 92 consecutive b
101. he Power PCB Gas passing through the resistive element FS1 will cause a pressure differential which will be measured at pressure transducer dP1 Pressure measured at dP1 will be directly proportional to the gas flow across the resistive element Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 20 3 3 2 3 Internal Compressor COMP De Holder Resistive Element Fig 3 7 Blender Flow Sensor In the event of a loss of high pressure Air the microprocessor will signal the internal compressor COMP to begin operation Loss of high pressure air will be declared by the microprocessor using feedback from the blender flow sensor FS1 dP1 During blending if the flow from SV2 is less than 30 Ipm it is assumed that the high pressure air source has been removed With the compressor in operation during blending if the flow from SV2 is greater than 36 lpm is assumed that high pressure air is restored and the compressor will be automatically stopped Compressor air is drawn into the ventilators pneumatic system through a sintered bronze filter element located on the rear of the pneumatic module The air is then drawn through a series of chambers adjacent to the main reservoir cnambers which reduce the overall sound of the compressor inlet gas Compressed air exits the compressor and is connected to the main air supply system through the compressor unloading valve SV3 Fig 3 8 Internal Compressor
102. he coment termes tbe ava itt a Satori Fie Select firmware File Laio ED basati and Donrded Too Medeg vartio ia CL 4 Must 122 018 Tin afery 2 018 Ten My Sad sere ebria 2 062 Tin Docente Engreosed ty a As for sian Med Choose COM Part A Mac Sead irat goa Karp ha daio sta COM poton pr A Chorn cr he e avalide COM pis Adb E n dl ko evelebin COM pot Backup compressit in medos i soul Enguera ty 14 55 erin ate Figure 3 Com Port Selection The next screen shown in figure 3 will prompt you to select which of your computers communication ports you will use for the download process This may be set for com 1 or com 2 alternatively if using any other port such as a PCMCIA serial connection select Auto and the download utility will sense which port is in use Select Next when complete to proceed to the next step Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 Fireware Dowriioad Wizard IMT Information Management Technology AG Establish Surial Cosnechos and Download Firmware T Now eet yeu dove totum pom a ond co agat Trermaserng Di rec nes asma Poesia alza PFI Meanie tra pesar deber tento Engrasedte MT L5 tem mirri so Figure 4 Establishing Serial Connection The next step shown in figure 4 will attempt to establish communication with the ventilator through the appropriate Com port You
103. he ventilators performance verification are listed in the relevant section of this manual Clean ventilator exterior surfaces before disassembly Use isopropyl alcohol a bactericidal agent or a mild detergent and warm water solution and a clean lint free cotton cloth Vacuum ventilator interior using ESD safe equipment Do not clean the ventilator interior with high pressure air During disassembly clean parts as necessary with isopropyl alcohol Any excessively dirty items which cannot be cleaned should be replaced To ensure correct reassembly of the device take note of or label wire or tube positions before disconnecting parts Make sure that all tubes and harnesses are correctly installed and do not interfere with and can not be damaged by any moving parts It is important to follow appropriate ESD control procedures whenever the ventilator system is being serviced ESD can permanently damage ESD sensitive microelectronic components or assemblies when they are handled and even when no direct contact is made with the component or assembly ESD damage may not be immediately apparent however ESD damage will show up at a later time either as a premature failure of a component or assembly or as an intermittent failure which can be difficult and time consuming to locate Follow these minimum procedures and precautions to prevent ESD damage to the ESD sensitive microelectronic components and assemblies of the INSPIRATION ventilat
104. hed to off in the apnea back up screen apnea alarm will be triggered but back up ventilation will not occur Ventilation Continues Ventilation Continues Ventilation Continues Ventilation Continues Ventilation Continues nebulizer switched off automatically Ventilation Continues Ventilation Continues Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 116 8 6 Medium Priority Alarms Apnea Back Up Speaker Fault Volume Is Being Limited Note The apnea interval has elapsed without a patient triggered or mandatory breath being delivered Apnea back up ventilation has ben commenced A fault has been detected with the main alarm speaker Delivered volume is being limited by VTV Alarm settings A technical error has occurred refer to section 7 for further details Ventilator will switch to settings as defined in apnea setting screen Ventilation continues unaffected but with continuous tone audible alarm Ventilation continues with delivered volume limited Ventilator switches to ambient breathing mode As all volume monitoring is performed by the ventilators proximal sensor alarms for High Low tidal and minute volume will be disabled when the proximal sensor is switched to OFF Note As oxygen monitoring is performed by the ventilators internal O2 cell alarms for High Low Oxygen will be disabled when the oxygen sensor is switched to OFF Fo
105. his function permits the service engineer to observe the gain and offset values for the 02 measurement cell as determined during the O2 sensor calibration procedure Ext Flow Sensor This function permits the service engineer to observe gain values for the proximal flow sensor resulting from its calibration relative to the delivery transducer Screen 9 Fab Test 9 Fig 5 10 will allow the trained service technician to perform calibration of the Inspiratory Valve PV1 should it prove to be necessary During the calibration we introduce an exact pressure P1 tank to the reservoir The device will slowly increment the Inspiratory Valves PWM setting PV1 insp PWM until a flow of 1 lpm is measured at the Inspiratory Flow Sensor Flow internal This process is repeated for 300 800 and 1300 mbar respectively and the PWM settings for each are stored to NVRAM Performing the calibration as we do at a low medium and high pressure level will provide valve controller with a look up table for lift off signal across the normal pressure range for the reservoir for use during normal breath delivery Calibration of PV1 must be performed following replacement of Inspiratory Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 76 valve PV1 910021 Motherboard PCB F 720510 Control PCB F 710510 or when performance testing indicates that it may be necessary Note FabTest9 PUI Adjust Preumatios Nebulizer
106. iance resistance on lung simulator 2 Rezero all pressure transducers Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 101 PEEP Pressure Reading Oxygen Delivery PTS O2 Reading Vent 02 Reading Alarm Operation Disconnect Alarm Silence High Pressure Apnea Back Up PEEP Pressure out of range O2 reading out of range on PTS2000 O2 reading out of range on Ventilator Disconnect alarm is not active Alarm silence is not active High pressure alarm is not active Apnea alarm is not active Apnea back up ventilation is not active 3 Performed System Test 4 Replace PV1 Valve 5 Replace PV2 exhalation hub magnet 1 Ensure correct configuration compliance resistance on lung simulator 2 Rezero all pressure transducers 3 Performed System Test 4 Replace PV2 exhalation hub magnet 1 Perform full 2 point calibration of PTS2000 O2 sensor 1 Perform calibration of the ventilators O2 sensor 2 Replace 02 Sensor 1 Ensure that test lung has been removed from the wye 2 Verify that alarm settings are appropriate 1 Press alarm silence key again and verify appearance of icon in display screen 2 Verify operation of the alarm silence key using fab test 2 1 Ensure that the wye is fully occluded 2 Verify that alarm settings are appropriate 1 Verify the ventilator settings ensure that device is set to Spont mode and that apnea p
107. ibbon cable from the lexan keypad from the Controller PCB Using 2mm hex driver loosen the set screw securing the knob to the rotary control knob device Using 2 5mm hex driver remove 3 x cap head screw securing the nose cone to the front housing Starting in one corner lift and peel the lexan keypad up and clear of the front housing Following removal ensure that front housing is cleaned and that the front lens is secure prior to installing new lexan keypad To remove the compressor platform from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove top cover enclosure 9 16 2 and place on static dissipative mat Using 2 5mm hex driver remove 4 x cap head screws securing the compressor platform to the top edge of the bottom housing Loosen the 2 remaining screws and rotate compressor platform to an upright position allowing free access to all connections then retighten the screws Using flat bladed screwdriver loosen 2 x hose clamps then disconnect 2 x pneumatic hoses connecting the compressor to the pneumatic module Disconnect the electrical harness running from the compressor pump at the Power PCB then disconnect from Sol 3 unloading valve Disconnect electrical harness running from the mains inlet module to power supply module at the inlet end Disconnect the Power Supply output cable at the Power PCB While supporting the compressor platfor
108. ification Record Appendix D Inspiration Series Technical Manual F SVSMAN Revision 01 01 2004 i Ven Medical Ltd INSPIRATION SERIES VENTILATOR PERFORMANCE VERIFICATION RECORD Customer Software Vent Software Power Model O Inspiration LS Inspiration ST LJ Original Hardware Power Serial Number Hardware Controller Next PM Due Hardware Sensor Ventilator Hours Fab Test 11 Compressor Hours Fab Test 11 CEE ti e EO 7 ETE eme mi Pass Y7N Sof Test Sia Dow o Os 7 Um Limit Result Pass Y N Fabrication Test Fab Test 5 6 6 2 Calibrations and System Leak Test J Umt Result Pass VIN System Leak Test Results OK Des OM Forward Current Leakage lt 3004A all units Reverse Current Leakage lt 3004A all units OK System Compliance Proximal Sensor Calibration Oxygen Sensor Calibration Operational Tests 6 6 3 Chapter 1 Gas Sources Test1 Limit Result __ PassY N DO toss0_ TossO2Alam Os UN OP Roser _AlarmCancels_ s UNO tos Ar CompressorStans Ue UNO Reset CompressorSiops Ue UNO Less Air Compressor _Loss Air Alarm ves Omo Loss AllSupply Loss rioo Ue UNo O LossAliSuppy Int Pressuretow Ue Omo cas Volume Accuracy Tetz Um J Result Pass YIN OO TidalVolume TO0mis20m Os Tidal Volume Exhaled Vie 100mis 30m Yes Respiratory Rate 0bpm
109. ile location Verify that the required version of software is available on your computer During software download you will be required to install the latest version of system software to your ventilator The required software file should be stored to a convenient file location prior to commencing the download To verify that you have the latest version of software available you should refer to the service section of our website http www event medical com In the event that you do not have the latest version filed locally it may be downloaded from this website location Save the software file eventX Y Z tim to a convenient file location CAUTION For safety and convenience only the current release version of system software should be retained on your PC As each new software version is released and downloaded please ensure that old versions are deleted or archived Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 ili Software Download Procedure Ventilator MWI Software With your computer powered on ensure that you have at least one serial communications port available for communication with the ventilator Attach the software download cable F910085 to an available RS232 port on your PC as shown in figure 1 e If installing main ventilator system software connect the opposite end of the software download cable to the RS232 port on the ventilators rear panel e If installing mini web interfa
110. in sections 3 2 and 3 4 Oxygen measurement A galvanic cell is positioned in the inspiratory manifold to measure delivered oxygen concentrations and has a range between 0 and 103 Display of monitored data All data is displayed by a color alarms and settings liquid crystal display LCD C o120 The INSPIRATIONTM ventilation system complies with the requirements of directive 93 42 EEC concerning Medical Devices and therefore bears the CE mark IEC 601 1 Classified as protection class Type B internally powered drip proof equipment continuous operation International Standards Meets IEC 601 1 EN60601 1 IEC 601 1 2 EN60601 1 2 EN794 1 ASTMF1100 90 IEC 60601 2 12 1988 ASTM F1054 87 ISO 5356 1 CE Notified Body SGS UK Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 10 2 5 9 Device Labels and Symbols xxx BATT Nebulizer Flow sensor Ethernet A R IPX1 O2 2 6bar 29 86psi Air gt 6bar 29 86psi These device labels and symbols appear on the INSPIRATION TM On Off Power switch Alarm Mute key Back up battery time status On battery back up Nebulizer nipple connector Flow sensor connector Device connected to mains RS232 connection port Nurse call connection port Ethernet connection port Refer to manual for Information or directions warnings intended to prevent potential damage to the patient caregiver or device Designates
111. inal test record Observe and record the reading for respiratory breath rate Reading should be 25bpm 2 5bpm Record result on the final test record Switch UUT screen to show Monitoring ensure that Vte reading is 300ml 90ml Record result on the final test record On completion make the following changes to the ventilator settings Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 93 Ventilation Mode VCMV rif volume om Respiratory Rate tbem IT TO som C mresa tipo Pressure msgertei ST eee como home justas roque Allow a minimum of 10 breaths for the device to stabilise at the current ventilation settings On the PF300 numerical screen 1 record the measured volume for 5 consecutive breaths then calculate average for the delivered tidal volume Ensure that tidal volume is 600ml 120ml Record result on the final test record Observe and record the reading for respiratory breath rate Reading should be 15bpm 1 5bpm Record result on the final test record Switch UUT screen to show Monitoring ensure that Vte reading is 600ml 120ml Record result on the final test record On completion make the following changes to the ventilator settings Ventilation Mode Allow a minimum of 10 breaths for the device to stabilise at the current ventilation settings On the PF300 numerical screen 1 record the measured volume for 5 consecutive breaths then cal
112. ing Inspiration in pressure targeted breath delivery Pcontrol Psupport PV1 will be regulated using feedback from the internal pressure sensor P2 so as to achieve the target pressure During ex halation PV1 will be regulated using feedback from the internal flow sensor FS2 dP2 to achieve the required base flow Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 26 3 3 4 In order to protect the patient during abnormal operation two safety Safety Valve Block features are incorporated into the pneumatic safety valve block which interfaces the main patient gas delivery path The safety valve block incorporates both over pressure protection and a safety valve as described in the following text Fig 3 15 Security Block 3 3 4 1 In order to protect the patient from any harm resulting from high circuit High Pressure Relief pressures a high pressure relief valve is incorporated into the devices Valve HPRV safety valve block The circuit high pressure relief valve is a mechanical relief valve with a set cracking pressure of 120cmH20 In the event of a pressure in excess of this occurring in the patient system as might happen in the event of an occlusion the high pressure relief valve will open automatically to limit pressure to 120cmH20 High Pressure Relief Valve Exhaust Port SV HPRV Fig 3 16 High Pressure Relief Valve Inspiration Series Technical Manual F SVSMAN Revision
113. iration Series Technical Manual F SVSMAN Revision 2 0 01 2004 56 4 3 4 User Calibration Errors System Leak Test Error 6 Pressure Drop Error 7 Pressure Rise Error 8 Max Time To Pressure Error 10 Deviation High Error 11 Error Emptying Tank Flow Sensor Calibration Error 12 High Pressure Error 13 Deviation High On completion of each of the self test routines the device will report a pass or fail status In the event of a failure of any test the device will report a specific error number indicating the nature of the problem The respective error codes a definition there of and possible steps for resolution are listed in the table below Excessive Pressure Drop During System Test Excessive Pressure Increase During System Test Unable To Adequately Pressurize Patient System Flow At Transducer dP2 Out Of Range Tank Pressure Remains Above 100mbar Pressure Out Of Range Zero Adjustment dP2 1 Ensure closed patient system 2 Run system test with single tubing limb connect between outlet amp exhalation cover 3 Remove system tubing and verify flow from PV1 4 Perform internal leakage test 5 Replace Sensor PCB 1 Forward leak through PV1 valve 2 Forward leak through Solenoid 4 if nebulizer is connected 3 Replace Sensor PCB 1 Ensure closed patient system 2 Run system test with single tubing limb connect between outlet amp exhalation cove
114. irm when the process has been successfully completed On completion switch the device OFF and remove the download cable Power Software Installation Procedure e In accordance with the Inspiration Series Service Manual remove and set aside the ventilators top housing e With your computer powered on ensure that you have at least one serial communications port available for communication with the ventilator e Attach the software download cable to the available serial port on your PC as shown in figure 1 e Attach the other end of the software download to the vacant connector on the Power PCB immediately adjacent to the SW Flash EPROM shown in figure 6 e The procedure is performed largely as described above with the following alterations e Atthe firmware selection stage change file type to hex and select file in the form eVent PowerboardVX X X hex e As with system software installation you will be prompted by the download application screen to power cycle off on the ventilator at the beginning and end of the download process e Whenever prompted to do this you press the power processor reset switch positioned immediately adjacent to the Power PCB Flash EPROM Power Software Download Connection E diddddid Power Software Flash EPROM Figure 6 Power Software Download Port Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 vii Post Software Installation Checks Switch on the sub
115. ject device and allow it to run through system test Should self test report an OK status the device may be switched off and returned to operational use Should self test report any status other than OK refer to the troubleshooting section of this procedure NOTE Some releases of system software may require that additional calibration configuration and other steps be performed before the device may be returned to operational use Refer to the software release notes or applicable Technical Information Bulletins for verification of these additional requirements Troubleshooting e Inthe event of experiencing any problems or technical errors refer to the troubleshooting section of the Inspiration Ventilator system service manual Technical Assistance Should you experience any problems during or following the upgrade process please contact you local eVent Medical representative Alternatively you may contact eVent Medical directly at our group email address service event medical com or at our technical hotline 44 788 4366160 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 viii THIS PAGE INTENTIONALLY LEFT BLANK Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 THIS PAGE INTENTIONALLY LEFT BLANK Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 Inspiration Communication Interface Appendix B For convenience the following pages p
116. k Available of air supply up is switched to on in configuration 2 Ensure that the compressor harness is secure 3 Replace compressor Compressor Stalls Compressor stops during operation 1 Verify operation of compressor unloading valve 2 Ensure that exhaust is audible 3 Replace unloading valve 4 Replace compressor Air Supply Alarm Air supply alarm not active 1 Ensure that Air supply has been disconnected 2 Ensure that compressor back up is switched to off in configuration Volume Accuracy Tidal Volume Tidal Volume Readings Out of 1 Perform system test in order to Readings Range High Low calculate system compliance 2 Verfiy correct compliance and resistance in use on lung simulator Exhaled Tidal Exhaled Tidal Volume Reading Out 1 Perform system test in order to Volume Readings of Range High Low calculate system compliance 2 Ensure correct orientation of proximal sensor sensing lines straight up or down from wye 2 Perform flow sensor calibration 3 Replace proximal flow sensor 4 Verfiy internal calibration of PV1 and flow sensor Respiratory Rate Respiratory Rate Readings out of 1 Verfiy trigger type and setting Readings range high low Autocycling 2 Perform system test to ensure no leakage from system 3 Re zero pressure transducers 4 Replace Sensor PCB Pressure Accuracy Inspiratory Pressure Inspiratory Pressure readings out of 1 Ensure correct configuration Readings range High Low compl
117. kage rate a failure will be reported with a specific error number to prompt further investigation A full listing of the error codes and appropriate troubleshooting steps is provided at the back of this section e System compliance will be displayed at the bottom of the calibration screen and will be expressed as volume required per unit of system pressure The proximal flow sensor calibration is used by the operator in order to define the characteristics of the proximal sensor prior to use The calibration values will be stored in NVRAM and used during operation to ensure accurate measurement of exhaled tidal volume Vte On commencing system test the ventilator will firstly exercise the inspiratory valve PV1 in order to empty the gas reservoir On commencing proximal sensor calibration with zero flow through the delivery system the internal transducers dP2 and P2 and the proximal transducers dP3 and P3 will all be zeroed The device will initially deliver a flow of 30 lpm through the patient system and proximal sensor The device will record the differential pressure and resulting reference voltage at dP3 and determine the gain The device will determine from the gain from it whether an adult or infant sensor is connected If an infant sensor is connected the device will pass a 6 lpm flow through the patient system and proximal sensor If an adult sensor is connected the device will pass a 10 Ipm flow through the patient system and p
118. l Manual F SVSMAN Revision 2 0 01 2004 35 3 4 Inspiration The INSPIRATION ventilator electronics system use and regulate one of Electronic System three sources of electrical power to provide drive to and control of the ventilator pneumatic system The system also allows the operator to program settings via the user interface module and hence supervises all ventilator operations The INSPIRATION electronics system is comprised of the following components e Power Input Components e Power Supply PCB e DC Power Options e Power PCB e Sensor PCB e Controller PCB e Processor PCB e Graphic PCB e LCD Display e User Interface Lexan Keypad e User Interface Rotary control knob e Mini Web Interface Optional Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 36 90 250V AC external 24V external RS232 plan Deep discharge Deep discharge Foe protection protection mara put Filter and fuses Digital filter with 2 fuses out Battery monitor 1 Battery monitor 2 voltage current voltage current Power processor PP capacity capacity N Alarm monitoring 1 BE Serial bus Power management Digital Output Buzzer Esta SMBus Sator management Battery charger 1 Battery switch Battery chai 2 24V e dad toPP S Battery switch control Se je Bla sie gt gt gt gt K to PP gt to PP 2 3 2 digital outputs aaa a 8 6 g
119. lace into a static shielding bag To remove the Controller Motherboard PCB from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Note Record the ventilator and compressor operating hours and any relevant error code information on service record prior to replacing the Controller PCB This information is available on fab test 11 Remove top cover enclosure 9 16 2 and place on static dissipative mat if Inspiration LS separate PU front bezel from front housing 9 16 3 Remove Graphic PCB and LCD display panel 9 16 7 Remove the Mini Web Interface PCB 9 16 5 Remove the Processor PCB 9 16 6 Remove the Graphic PCB 9 16 8 Using a 2 5mm hex driver remove 4 x cap head screw securing the Controller Motherboard PCB to the Graphic Plate Remove stand offs and place Controller PCB into a static shielding bag Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 128 9 16 12 Lexan Keypad Removal Installation 9 16 13 Compressor Platform Removal Installation 9 16 14 Compressor Pump Removal Installation To remove the Lexan Keypad from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove top cover enclosure 9 16 2 and place on static dissipative mat if Inspiration LS separate PU front bezel from front housing 9 16 3 Disconnect r
120. lation RS232 software upgrade Fig 3 25 Inspiration Electronic Diagram Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 37 THIS PAGE INTENTIONALLY LEFT BLANK Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 38 3 4 1 The power input components of the system comprise of the ventilator Power Input power cord and an EN60320 power input receptacle and line filter Components 3 The ventilator is rated for supply voltages of 100 240 VAC 50 60 Hz and is fused at 3 15 amps to accommodate both high and low voltage ranges Fig 3 26 Power Entrance Module 3 4 2 The power supply PCB is a true auto ranging assembly which is rated for Power Supply PCB supply voltages of 100 240 VAC 50 60 Hz It will output a single regulated 24 VDC supply which is routed onward to the Power PCB where the other required supply voltages will be generated The power supply assembly incorporates a power fail system which will signal the processor accordingly in the event of a loss of AC supply Fig 3 27 Power Supply Module Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 39 3 4 3 Internal Battery 3 4 4 External Battery Back up during a loss of AC supply is provided an internal battery pack The battery pack is comprised of two 12 VDC batteries which are connected serially at the Power PCB in order to provide a 24VDC supply In the Inspiration
121. lator Mounting Plate Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 140 10 3 Ventilator Accessories temo Ferito Decio Not Shown F 710522 Inspiration Ventilator Cart Deluxe Not Shown F 710523 Cylinder Mounts Dual Euro Cylinder Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 141 10 4 VENTILATOR CHASSIS Reference Only Front Housing Assembly Reference Only Bottom Housing Assembly Reference Only Compressor Module Demo Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 142 10 5 Front Housing Module 10 5 1 FRONT HOUSING MODULE INSPIRATION LS ER pane os F 730515 DE Lexan Screen German F 730515 ES Lexan Screen Spanish F 730515 FR Lexan Screen French F 730515 GB Lexan Screen English F 730515 IT Lexan Screen Italian F 730515 JP Lexan Screen Japanese F 730515 PL Lexan Screen Polish F 730515 PT Lexan Screen Portuguese F 730515 RU Lexan Screen Russian F 910005 Rotary control knob Encoder F 810011 Set Screw Knob F 730210 Knob Rotary control knob Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 143 Nose Cone German Nose Cone Spanish Nose Cone French Nose Cone English Nose Cone Italian Nose Cone Japanese Nose Cone Polish Nose Cone Portuguese Nose Cone Russian F 910244 Front Housing PU Complete includes ref 01 F 730221 Hinge Fr
122. llows a full listing of alarms which will be classified a Medium Priority In each case a description of the error and the ventilator response is listed Alarm Message Check flow sensor tubing Check Flow Sensor Air Supply Oxygen Supply Compressor High Respiratory Rate Low Respiratory Rate Check Pcontrol Pmax Description of Error The measuring tubes for the external flow sensor have either come loose or may be blocked The external flow sensor has been attached incorrectly The air supply has been interrupted and compressor back up is switched off in the configuration menu The oxygen supply has been interrupted The internal compressor has failed Respiratory rate is too high when compared with the low rate alarm limit Respiratory rate is too low when compared with the low rate alarm limit Pcontrol and or high pressure alarm settings are incorrect ie Pcontrol gt high pressure alarm setting Ventilator Response Ventilation continues Device switches over to pressure triggering mode Ventilation continues Device switches over to pressure triggering mode Ventilation continues with 100 oxygen where possible Ventilation continues with air supply 21 Ventilation continues with 100 oxygen where possible Ventilation Continues Ventilation Continues Ventilation Continues Pressure will be limited at the high pressure alarm setting until the settings are
123. low compared with alarm limit ExpMinVol Expiratory minute volume is too high compared with alarm limit ExpMinVol Inspiratory O concentration is too low Possible causes gas mixing system error O cell faulty monitor value too low compared with control value Oz sensor calibration must be performed Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 110 Error No 50 Alarm High Oxygen Inspiratory Oz concentration is too high Delivery Possible causes gas mixing system error O cell faulty monitor value too high compared with control value O2 sensor calibration must be performed Error No 51 Alarm Nebulizer Disconnect Nebulizer tubing has become disconnected from the ventilator or nebulizer vial Error No 52 Alarm Low Tidal Volume Expiratory tidal volume is too low compared with alarm limit for Vte Error No 53 Alarm High Tidal Volume Expiratory tidal volume is too high compared with alarm limit for Vte Error No 54 Alarm Apnea Back Up The apnea interval has elapsed without a patient triggered or mandatory breath being delivered Apnea Back Up ventilation at operator set parameters is now in operation Is active in V SIMV P SIMV and SPONT modes Error No 55 Alarm Speaker Fault Internal main alarm speaker may not be functioning correctly Note Message will be accompanied by a latching back up audible alarm signal Error No 56 Alarm Volume is Being
124. ly grip the inlet assembly water trap and rotate counter clockwise to remove Grip inlet filter and rotate counter clockwise to remove Replace as is necessary per PM schedule Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 131 9 16 20 Rear Panel Removal Installation 9 16 21 Oxygen Sensor Removal Installation 9 16 22 Internal Battery Removal Installation 9 16 23 Complete Pneumatic Removal Installation To remove the rear panel from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove top cover enclosure 9 16 2 and place on static dissipative mat Remove Air and O2 inlet assemblies 9 16 18 Using a 2mm hex driver remove 4 x CSK screws securing the rear panel to the ventilators bottom housing Disconnect harness from ventilators mains inlet filter while noting the orientation of the connections Disconnect all ground connectors from the primary grounding point on the rear panel while noting the orientation of the connections Noting the orientation of the connections disconnect the main DC harness from the external DC connector Disconnect cooling fan harness from the Power PCB To remove the oxygen sensor from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Original Devices Loosen the single captive screw securin
125. m use 2 5mm hex driver to remove the 2 remaining screws securing the compressor platform to the bottom enclosure Remove the compressor platform and place on static dissipative mat or in static shielding bag To remove the compressor pump from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove top cover enclosure 9 16 2 and place on static dissipative mat Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 129 9 16 15 Power Supply Module Removal Installation 9 16 16 Sensor PCB Removal Installation 9 16 17 Power PCB Removal Installation Remove the compressor platform 9 16 13 Using 2 5mm hex driver remove 4 x CSK screws securing the 2 plastic mounting brackets into position Pull the mounting brackets and damping inlays from either end of the compressors plate and set aside for re installation Using a flat blade screwdriver loosen 2 x jubilee clips and remove the 2 compressor hoses from the device To remove the power supply module from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove top cover enclosure 9 16 2 and place on static dissipative mat Remove the compressor platform 9 16 13 Using Philips No 2 screwdriver remove 4 x CSK screws securing the power supply module to the compressor platform Place power
126. m air O2 blender valves Inspiration and exhalation proportional valves nebulizer valve Safety Valve compressor system Using Philips No 2 screwdriver loosen 4 x CSK screws securing the rear panel to the bottom enclosure Ensure adequate space to disengage communications connectors from rear panel If sufficient room is not available rear panel should be removed Section Ref Using 2 5mm hex driver remove the 2 x cap head screws securing the Power PCB to the pneumatic module access through right side cut out and 3 x cap head screws securing the Power PCB to the lower housing Ease the Power PCB up out of the pneumatic module Care should be taken not to flex the PCB excessively or damage the transducer connections Place Power PCB into a static shielding bag Note Replacement Power PCB s are provided in an un programmed state Power system software must be installed following the repair Refer to appendix A for detailed instructions To remove the air and O2 inlet assemblies from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Using 3 0 mm hex driver remove 2 x cap head screws securing the relevant inlet assembly to the check valve block Remove inlet and set aside or disassemble as required To remove the inlet filters from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Firm
127. mance verification test verify that all equipment hold a valid calibration certificate and that sufficient warm up time has elapsed prior to making any measurements To ensure systematic performance verification and logical fault diagnosis perform these tests in the order given If you need to repeat a test the current control settings are completely defined at the beginning of each individual test Note If the performance verification is being run in the specified order you need only make changes to the ventilator control settings shown in boldface To locate the cause of any malfunction you should refer the troubleshooting information provided at the back of this section and section 7 of this manual Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 89 6 6 1 Electrical Safety Tests 6 6 2 Fabrication Tests 6 6 3 Operational Tests Follow these general guidelines when running the performance verification e f you note a problem during the performance verification verify that you have followed all procedures correctly before attempting to make a repair to the ventilator e When making ventilator settings be aware that because of interrelationships between some ventilator settings you may not always be able to make all settings in the indicated sequence e For convenience all alarms should be set to the maximum and minimum ranges available this will reduce the occurrence of nuisance
128. mit flow triggering to be used The proximal flow sensor FS3 is positioned at the patient wye The flow sensor is available in adult and Infant versions Each sensor has three proximal interface tubes which attach the sensor to the front console of the ventilator The two outer connections provide the pressures upstream and downstream of a resistive element the final centre connector is offset to ensure correct connection to the device Inspiration LS ST models will use a sensor version using tubing with a large internal diameter approx 3 0mm Earlier original models will use a sensor version using tubing with a small internal diameter approx 1 5mm The two sensing lines are connected internally to a differential pressure sensor dP3 located on the Sensor PCB with a tee off the downstream line providing a proximal airway pressure measurement Gas passing through the resistive element FS3 will cause a pressure differential which will be measured at pressure transducer dP3 Pressure measured at dP3 will be directly proportional to the gas flow across the resistive element The feedback from this sensor will be used by the microprocessor for monitored values for exhaled tidal and minute volume for sensing patient inspiratory effort and for the graphical loops and waveforms Fig 3 18 Proximal Flow Sensor Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 29 3 3 5 2 Proximal Pressure Transducer
129. n o Oxygen filt 28 Prev Next A Fig 5 11 Technical Screen 10 e Oxygen FIO2 Oxygen percentage to be delivered e PWM c 00 Determines the level to which PV1 will be opened and hence Peak flow demand e ADU This pull down menu allows settings for Adult ADU Paediatric PED and Infant INF to be selected in order to determine the maximum tank pressure e Stop Allows ventilation to be commenced and stopped With the settings defined and in use the measurements area will allow the following values to be monitored e Status Start Stop according to whether ventilation is active e P1 Tank Current system tank pressure e P1 Tank Max Maximum system tank pressure e P1 Tank Min Minimum system tank pressure e TAir Activation time for Air supply valve SV2 e TO2 Activation time for O2 supply valve SV1 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 78 e Blender Flow Flow measured at FS1 dP1 e Flow Air Flow from SV2 as measured at FS1 dP2 e Flow O2 Flow from SV1 as measured at FS1 dP2 e Oxygen 02 as measured at transducer e Oxygen filt 02 filtered signal In order to use this function effectively the device should have 2 gas sources available Air or Compressor and Oxygen 5 3 11 Screen 11 Fab Test 11 Fig 5 12 will allow the trained service technician Screen 11 Technical to view cumulative and diagnostic data The data available for this screen Log S
130. n external battery if connected when external battery power is exhausted or not available the internal 24 VDC battery will power the system Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 15 3 3 Inspiration Pneumatic System Fig 3 1 Inspiration Pneumatic Chassis The Inspiration series ventilator pneumatic system incorporates an innovative solid state manifold design concept which virtually eliminates the need for any internal ventilator tubing The system also incorporates an intelligent blending system eliminating the need for regulators at the gas inlet system Under microprocessor control the pneumatic system will regulate and mix the high pressure source gasses for delivery to the patient to provide therapeutic respiratory support The Inspiration pneumatic system may be categorized into a number of subsystems these are listed and defined as follows e Gas Inlet System e Gas Blending System e Gas Delivery System e Safety Valve Block e Proximal Measurements e Exhalation System e Oxygen Monitoring System e Nebulizer Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 16 HOSNIS KOHd 17 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 3 3 1 The gas inlet system fig 3 3 permits the connection of two high pressure Gas Inlet System gas sources Air Oxygen to the ventilator via DISS high pressure connectors It
131. n a range too close to the ventilator Do not operate the ventilator in a magnetic resonance imaging MRI environment Section 8 describes the possible ventilator alarms and what to do if they occur Consult with your institutions biomedical engineering department in the case of interrupted ventilator operation and before relocating any life support equipment Should further assistance be required contact your local eVent Medical representative Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 2 2 1 introduction 2 2 How To Use The Manual 2 3 Safety Information General Information This section of the manual has been formulated to provide you with introductory information concerning the eVent Medical Inspiration series ventilator system The section comprises a brief product description specifications tooling maintenance summary and an introduction to the controls and indicators The information within is not intended as a sole source of reference and has been intended for use in conjunction with the Inspiration operators manual Both manuals should be referenced when performing any maintenance to the system Only medical air and medically pure oxygen should be used for ventilation Anaesthetics and potentially explosive gases should not be used Please also ensure that the air used is completely oil free To avoid any potential fire hazard Keep all matches lighted cigarettes and other sourc
132. n keypad from the Controller PCB ST and Original Devices With attention to appropriate anti static precautions and using 3 0mm hex driver remove 4 x cap head screw securing the complete graphic module to the front housing Remove the complete graphic module and plate on to static dissipative mat with display facing upward Using 3 0mm hex driver remove 4 x cap head screw securing the LCD display to stand offs If Inspiration LS the LCD display panel will now be Carefully disconnect the backlight cable from the Controller PCB and the display ribbon cable from LCD LS Devices Only With attention to appropriate anti static precautions and using 3 0mm hex driver remove 4 x cap head screw securing the complete graphic module to the front housing Carefully disconnect the backlight cable from the Controller PCB and the display ribbon cable from LCD All Devices Place LCD and remaining Graphic module components into a static shielding bag To remove the Graphic PCB from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove top cover enclosure 9 16 2 and place on static dissipative mat if Inspiration LS separate PU front bezel from front housing 9 16 3 Remove Graphic module and LCD display panel 9 16 7 Using 2 5mm hex driver remove 4 x cap head screw securing the Graphic PCB to the Controller PCB Carefully unplug the Graphic PCB from the Con
133. n the reservoir within 1 of the set FiO2 level The following blender system statuses are possible Gas mixing Reaction from INSPIRATION Alarm system status message information O and air supply Air and gas are being mixed This status allows the No alarm activated normal most exact mixture to be attained irrespective of messages or status the input pressure from both gases information 1 FI O2 O and As soon as the air supply fails the compressor is Info compressor switched on The mixture is now made up of Flow Trigger Not activated i e air compressor air and O2 The mixture accuracy is Available supply failure now 5 FI O The compressor can only be activated if compressor backup has been enabled in the configuration menu 19 Calibrations and nebulizer function are not available O activated i e If the air supply fails the INSPIRATION tries to Alarm High air supply and start the compressor If compressor backup has High Oxygen compressor not been enabled in the configuration menu the failure compressor cannot be activated and the gas Alarm Medium mixture will only contain 100 oxygen Air supply Air only activated The oxygen supply has failed Mixture will only Alarm High i e Oz failure contain air Low Oxygen Alarm Medium Oxygen supply Compressor The air supply and oxygen have failed If Alarm High activated i e O2 compressor backup has been enabled in the Low Oxygen and air supply configuration th
134. normal operation of the device Available selections are European or US With European philosophy set breath timing will be governed by the operator setting of I E ratio for both volume and pressure controlled Breaths With US philosophy set breath timing will be governed by the operator setting of Peak Flow for volume control and Inspiratory Time for pressure control Altitude Compensation Allows the operator to set the altitude at which the device is being operated Will be used by the device to compensate measurements for pressure Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 63 4 4 3 Configuration Screen 2 sensor meresgsor backup a Burzeri Mor uU Fig 4 6 Configuration Screen 1 Configuration screen 2 will permit the operator to configure some of the more general attributes of the ventilator The attributes which may be configured are as follows Language Allows the operator to configure the operating language of the ventilator from the available selections e English French German Italian Nemet Hungarian Polish Portuguese Russian Spanish Japanese e Chinese Time Allows the operator to set the current time stored by the device Correct setting of the time will ensure the accuracy of records stored within the alarm and technical error logs Date Allows the operator to set the current date stored by the device Correct
135. not O2 calibration is not available O2 calibration is interrupted available because there is no oxygen supply or the O2 sensor has been disabled in the configuration menu Flow calibration not The flow sensor cannot be Flow calibration interrupted available calibrated because it is disabled in the configuration menu Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 119 THIS PAGE INTENTIONALLY LEFT BLANK Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 120 9 Service amp Repair Disassembly 9 1 Introduction This section of the manual describes how to repair the ventilators major subassemblies and their major components These repair procedures will include removal installation as applicable This section does not provide a complete breakdown of all assemblies and complete disassembly rather disassembly to what the manufacturer deems necessary and reasonable Repair procedures are provided for all major assemblies and a complete illustrated parts breakdown is included within section 10 of this manual 9 2 Repair Safety When servicing the Inspiration ventilator system be sure to familiarise yourself with and adhere to all posted and stated safety warning and caution labels on the ventilator and its components Failure to adhere to such warnings at all times may result in injury or property damage To prevent patient injury do not use the ventilator if it requires
136. nspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 6 2 5 3 Monitoring patient values Pressure values Volume Time Parameters Respiratory Mechanics Special Values Time Curves and Loops Ppeak Peak Pressure 0 to 120 cmH20 Accuracy 3 cmH20 4 PEEP PEEP Pressure 0 to 120 cmH20 Accuracy 3 cmH20 4 Pmean Mean Pressure Oto 120 cmH20 Accuracy 3 cmH20 4 Pplateau Plateau Pressure 0 to 120 cmH20 Accuracy 3 cmH20 4 Vte Exhaled Tidal Volume 0 to 2000 ml Accuracy Oml 40 ml 2ml 5 Accuracy 41ml 2000ml 10ml 5 Exp MinVol Oto 20 L Accuracy 0 011 5 Resp Rate measured breaths per minute 0 to 300 b min Accuracy 0 01 bpm 1 Ti inspiration time 0 01 to 9 0 seconds Accuracy 0 01 sec Ti Ttot calculated Itime divided by cycle time H L ratio of time at high and low PEEP levels when SPAP is active Rinsp inspiratory resistance of airways and tubes cnH20 sec Cstat static compliance lung stiffness L emH20 Oxygen inspiratory oxygen concentration 15 to 103 Accuracy 5 of full O2 scale RSBI calculated breathing rate divided by tidal volume b min ml Pressure over time measured proximally or internally in cmH20 Flow over time measured proximally or internally in cmH20 Volume over time measured proximally or internally in ml Pressure volume loop measured proximally or in
137. nstallation Following removal place the PU front bezel on to a grounded static dissipative mat or into a static shielding bag To remove the rotary control knob assembly from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove top cover enclosure 9 16 2 and place on static dissipative mat if Inspiration LS separate PU front bezel from front housing 9 16 3 Disconnect the rotary control knob assembly cable from the Controller PCB Using 2mm hex driver loosen the set screw securing the knob to the rotary control knob device Using nut driver or wrench remove the nut and washer from the shaft of the rotary control knob Remove the rotary control knob from the top cover enclosure retaining all mounting hardware To remove the Mini Web Interface PCB from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove top cover enclosure 9 16 2 and place on static dissipative mat if Inspiration LS separate PU front bezel from front housing 9 16 3 With attention to appropriate anti static precautions and using 2 5mm hex driver remove 2 x Cap Head screw securing the Mini Web Interface PCB to the Controller PCB Carefully unplug the Mini Web Interface PCB from the Controller PCB and place into static shielding bag Note Replacement MWI PCB s are provided in an un programmed state
138. nt any possible damage to components downstream in the system Note If ventilator is being operated in a location with a known bad Air or 02 supply the manufacturer recommends the use of an additional large capacity self dumping water trap upstream of the ventilators high pressure inlets Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 18 3 3 1 4 Inlet Check Valves CV1 CV2 Fig 3 4 Section Through Water Trap Having passed through filter and water trap each of the high pressure gas supplies entering the ventilator is passed through a check valve fig 3 5 Check valve CV1 is located in the O2 supply path and check valve CV2 is located in the Air supply path The check valves function and are biased so as to allow an un obstructed flow of high pressure gas into the ventilator O2 and Air supply systems In the event of a single failure condition in the blending system the checking action of these valves will prevent any back flow of gas through to the high pressure source and will prevent any contamination of the surrounding supply system Under no flow conditions the check valve will be forced closed by an internal return spring ee hi No no LU b S L Mi n A LA 2 4 F 3 a ia Valve forced open by rm MINE Valve forced closed flow from high A A a during no flow or pressure source Ml back flow conditions wil h gt 117 A ay E Td mp il E b x TTT Ra e e O Fig 3 5
139. ntrol range 0 500 for PV1 and 0 1000 for PV2 e Once the circuit has been energised technician should observe the device for an appropriate response in order to determine whether it is operating normally e Once testing has been completed each of the circuits should once again be de energised e In the same way the lower section of this screen will allow the technician to test a number of the electrical circuits Once again the technician should navigate and select the appropriate function then observe for desired operation e The following circuits may be tested in this way Master SOL 1 02 SOL 2 Air SOL 4 Neb ABV Full ABV Half PV1 Insp PV2 Exp Compressor SOL 3 Comp Nurse Call Buzzer Buzzer Setting Alarm LED Fan Speed Pneumatic Master Valve Feed Blender Supply Valve O2 SV1 Blender Supply Valve Air SV2 Nebulizer Supply Valve SV4 Ambient Breathing Valve ABV Delivery Proportional Valve PV1 Expiratory Proportional Valve PV2 Compressor Pump Comp Compressor Unloading Valve SV3 Nurses Call Relay On Off 0 100 Front Panel Alarm LED Cooling Fan Slow Fast Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 68 5 3 2 Screen 2 Input Data Screen 2 Fab Test 2 Fig 5 3 will allow the trained service technician to observe the 16 channels of raw measured data being fed to the A D converter The viewable information includes raw data from the pressure t
140. ocessor Supervision A watchdog circuit located on the controller PCB monitors at all times the operation of the power processor located on the Power PCB If it anytime it determines there is a problem which could compromise safe ventilator operation it will annunciate a technical error and place the unit in to ambient breathing mode Fig 3 31 Processor PCB Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 44 3 4 9 The Graphic PCB is mounted inside the graphic module piggy backed to Graphic PCB the reverse of the controller PCB The graphic PCB drives the LCD display by means of an 8 bit parallel interface There are three separate versions of this PCB according to the type of device The different versions appear similar but are not interchangeable Information to be displayed will be received from the main processor PCB then processed locally into the required display format by means of an on board 16 bit micro controller Fig 3 32 Graphic PCB 3 4 10 A single flat panel colour LCD display is incorporated within the ventilators User Interface Display front panel in order to provide the operator with ventilator settings and patient data information Fig 3 33 LCD Display The versions of the LCD panel are available according to the type of device The Inspiration LS device uses a 12 1 TFT display panel Inspiration ST uses a 6 4 full VGA display panel and Original Inspiration model uses
141. og technical errors will be highlighted with an asterix 7 3 Technical Error Refer to the following table in order interpret the recorded technical List errors The first column with list in numerical order the specific error codes The second column will provide a description of the possible cause The final column will suggest possible steps to identify the specific triggering condition The suggested steps are sequenced in order of the most probable malfunction in order to give the most efficient corrective action It is possible that the suggested steps may not always provide a fix to the particular problem Should this occur refer to your local technical support specialists for further recommendations 7 3 1 Technical Error List TF01 Technical Fault Configuration EEPROM 1 Replace Controller PCB memory defective TF02 Technical Fault Configuration EEPROM 1 Replace Sensor PCB memory defective TFO3 Technical Fault Pressure Sensor Gain not 1 Perform re zero of all pressure valid Sensor PCB EEPROM transducers Fab Test 5 2 Perform temperature drift adjustment Fab Test 12 3 Replace Sensor PCB TF04 Technical Fault Configuration EEPROM 1 Replace Power PCB memory defective Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 103 TFO5 Technical Fault NVRAM Defective 1 Perform Checksum test on NVRAM Fab Test 3 2 Clear amp Test NVRAM and fully recalibrate the device
142. oltage OOR ADC1 2 correctly 2 Ensure Controller ribbon cable is seated correctly 3 Replace Sensor PCB 4 Replace Power PCB 5 Replace Processor PCB Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 104 TF15 Technical Fault Reference Voltage on ADC1 1 Ensure Sensor ribbon cable is seated Out Of Range correctly 2 Ensure Controller ribbon cable is seated correctly 3 Replace Sensor PCB 4 Replace Power PCB 5 Replace Processor PCB TF16 Technical Fault Reference Voltage on ADC2 4 Ensure Sensor ribbon cable is seated Out of Range correctly 2 Ensure Controller ribbon cable is seated correctly 3 Replace Sensor PCB 4 Replace Power PCB 5 Replace Processor PCB TF17 Technical Fault 5v Supply Voltage Out of 1 Replace Power PCB Range TF18 Technical Fault Software Stack Corruption 1 Re install system software 2 Replace Processor PCB TF19 Technical Fault Communication with PIC 1 Verfiy security of all ribbon connectors processor dead and cabling to pneumatics 2 Reset power processer 6 4 12 1 3 Replace Power PCB 4 Replace Processor PCB 5 Replace Controller PCB TF20 Technical Fault Value of pressure sensor P 41 Perform re zero of all pressure out of range transducers 2 Replace Sensor PCB TF21 Technical Fault Value of pressure sensor dP2 41 Perform re zero of all pressure out of range transducers 2 Replace Sensor PCB TF22
143. onents aside Using hex driver remove 2 x cap head screw securing the exhalation valve to the bottom pneumatic chassis Withdraw exhalation valve from the pneumatic chassis and set aside Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 136 10 Paris Lists 10 1 Introduction This section begins by showing the entire ventilator system including accessory items Subsequent figures show ventilator subassemblies and their component parts Alphabetic and numeric parts indexes are also included at the back of this section to assist in the identification of the correct components Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 137 10 2 Ventilator Assembly 10 2 1 VENTILATOR ASSEMBLY MODEL F7300000 INSPIRATION LS lemno 01 F 7300000 DE Inspiration Ventilator German F 7300000 ES Inspiration Ventilator Spanish F 7300000 FR Inspiration Ventilator French F 7300000 GB Inspiration Ventilator English UK F 7300000 IN Inspiration Ventilator English IN F 7300000 IT Inspiration Ventilator Italian F 7300000 JP Inspiration Ventilator Japanese F 7300000 PL Inspiration Ventilator Polish F 7300000 P T Inspiration Ventilator Portuguese F 7300000 RU Inspiration Ventilator Russian F 7300000 US Inspiration Ventilator US Not Shown F 710102 Inspiration Ventilator Cart Standard Not Shown F 710513 Inspiration Ventilator Cart Transport Not Shown F 710522 Inspiration Ventila
144. ont Bezel 05 F 730203 DE F 730203 ES F 730203 FR F 730203 UK F 730203 IT F730203 JP F 730203 PL F 730203 PT F 730203 RU Do e ES Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 144 02 F 720515 DE Lexan Screen German F 720515 ES Lexan Screen Spanish F 720515 FR Lexan Screen French F 720515 UK Lexan Screen English F 720515 IT Lexan Screen Italian F 720515 JP Lexan Screen Japanese F 720515 PL Lexan Screen Polish F 720515 PT Lexan Screen Portuguese F 720515 RU Lexan Screen Russian 0 o _ Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 145 F 710203 DE F 710203 ES F 710203 FR F 710203 UK F 710203 IT F710203 JP F 710203 PL F 710203 PT F 710203 RU Nose Cone German Nose Cone Spanish Nose Cone French Nose Cone English Nose Cone Italian Nose Cone Japanese Nose Cone Polish Nose Cone Portuguese Nose Cone Russian Do 09 F 910241 Front Housing includes Ref 01 02 03 Screw Graphic Module Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 146 10 5 3 FRONT HOUSING MODULE INSPIRATION ORIGINAL F 710211 Glass Lens Display F 910005 Rotary control knob Encoder F 810011 Set Screw Knob 01 F 710212 DE Lexan Screen German F 710212 ES Lexan Screen Spanish F 710212 FR Lexan Screen French F 710212 GB Lexan Screen English F 710212 IT Lexan Screen Italian F 710212 PL Lexan Scre
145. oo Conraer PB Original Oy e Foros Pose OOOO S 0 Esso Stans On i Processor OOO Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 153 10 7 Ventilator Housing Assembly 23 22 20 19 18 17 o 15 10 7 1 LOWER HOUSING INSPIRATION LS ST teme nho O esco Eco E Co e F 810217 Cord teaei US Japan F810016 810016 Screw cord retainer cord Screw cord retainer Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 154 E Free sa Label to from Patient JP only Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 155 F 710201 Bottom Housing F 910252 Cooling Fan FRU F 710208 Inserts Rail Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 156 Not Shown F 810019 Serrated washer cooling fan F 810018 Nut cooling fan Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 157 10 8 Ventilator Pneumatic Chassis 10 8 1 VENTILATOR PNEUMATIC CHASSIS item Ne Ferito espia PCB Assembly Power Board LS and ST o renos som Cap Head PowerSensor PCE 08 Reference oy Font Bock Assemby oa Reference On Sensor Book 2 Assomby PCB Assembly Power Board original only Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 158 F 920061 Ribbon Cable Sensor
146. operator to run a number of self test and calibration routines in order to configure the device for patient use The calibration routines offered are as follows e FIO2 Sensor Calibration e Proximal Flow Sensor Calibration e System Test Leak Test A detailed description for each of these calibration routines is defined in the following paragraphs Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 53 4 3 1 System Leak Test Fig 4 3 User Calibrations Screen The system leak test is used in order to verify the integrity of the patient tubing system components Running the test will allow the operator to quantify and eliminate any leakage from the patient tubing system prior to clinical patient use In addition to leakage the system test will also measure the total compliance of the patient tubing system The measured system compliance factor will then be used to compensate volume delivery on a breath by breath basis in order to ensure accurate volume delivery On commencing system test the ventilator will firstly exercise the inspiratory valve PV1 in order to empty the gas reservoir On completion the device will ensure that the reservoir is adequately charged if necessary the internal compressor will be started to charge the system this will take approximately 10 seconds With zero flow through the patient system transducer dP2 will be zeroed When ready the device will prompt the operator to
147. or system Use a personnel grounding system Before opening the ventilator Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 122 9 9 Repainting 9 10 Non Conforming Parts 9 11 Replacement Parts enclosure ensure that a personnel grounding system incorporating wrist strap static dissipative mat and ground cord is worn correctly and is properly connected to reliable ground Follow correct procedures for use of static dissipative mat Place tools test equipment and the ESD sensitive device on the mat before starting any repairs Conduct all work from the mat Never place nonconductive items on the mat Handle ESD sensitive components properly Do not handle ESD sensitive component connection points connector pins leads or terminals Keep nonconductive materials away from work space Static charges from nonconductive material may not be removed by grounding Items of this nature should be kept well clear of the work space when handling ESD sensitive devices Follow correct procedures for static shielding bags Store and transport all ESD sensitive devices in the shielding bags at all time except when being worked on Never place more than one ESD sensitive device in a static shielding bag Never place static generating nonconductive material inside a static shielding bag with an ESD sensitive device Place any faulty ESD sensitive devices in a static shielding bag immediately after removal to prev
148. otacted jumper in place Flow trigger is not available Possible causes Flow sensor is attached incorrectly flow sensor requires calibration device is running on internal compressor Nebulizer is not available Possible causes Device in infant mode or peak flow is below 7lpm Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 112 Error No 118 Info 100 O2 Not Available 100 O is not available Possible causes no oxygen supply available while 100 O is being administered or O calibration has been started Error No 119 Info O2 Calibration Not O2 Calibration not available Available Possible cause 02 sensor not enabled High pressure gas sources not available Error No 120 Info Flow Calibration Not Flow Calibration not available Available Possible cause Proximal sensor may be disabled in configuration mode Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 113 THIS PAGE INTENTIONALLY LEFT BLANK Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 114 8 Alarm Messages 8 1 Introduction 8 2 Audible Alarms 8 3 Alarm Signals 8 4 Alarm Log This section of the manual has been devised to allow the trained service technician to interpret the alarm messages which may occur during normal operation of the device and which may be contained within the devices alarm log All audible and visual alarm
149. ovide feedback on flow and pressure information to the processor during breath delivery Incorporated into the PCB are four pressure transducers which are used for breath delivery and proximal measurements Fig 3 30 Sensor PCB Breath Delivery Transducers As described previously two transducers are used as feedback signals for control of the delivery proportional valve PV1 The differential transducer dP2 provides feedback to the Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 42 3 4 7 Motherboard Controller PCB microprocessor on internal gas flow through the inspiratory module The pressure transducer P2 will provide feedback to the microprocessor on the internal pressure within the inspiratory module Proximal Measurements As described previously two transducers are incorporated to provide feedback and patient data regarding patients exhaled tidal volumes and he proximal airway pressure The signal from differential transducer DP3 provides feedback on the patients exhaled flow and tidal volume The pressure transducer P3 will provide information on the patients proximal airway pressure O2 Sensor Interface The ventilators integral O2 measurement cell interfaces with the electronic system through an interface circuit located on the sensor PCB Barometric Pressure Transducer On later versions of the Sensor PCB Rev 04 and above an additional atmospheric pressure transducer
150. ows e main Mc 24v Indicates the main system current draw measured at the Mc e SW version Pic Displays the current SW revision for the Pic e Offrequest Indicates whether there are an pending off requests Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 72 5 3 5 Screen 5 Sensor Adjustment Screen 5 Fab Test 5 Fig 5 6 will allow the trained service technician to perform a zero calibration for each of the pneumatic pressure transducers In order to perform this calibration to any given pressure transducer the technician should use the process below FabTestS Sensor Rdjust Status Zero Idle P2 Valve 0 3 mbar Gain dP2 Valve 0 24 mbar 3 Proximal 0 02 mbar dP3 Proximal 0 04 mbar em P2 Valve IMI Pi Tank 216 mbar dPi Blender 0 mbar Bain 305 Point Int flow CdPZ gt 2 2 l min mbar Ext flow dP3 3 4 l min Elen flow CdP13 7 mis Oxygen 28 x 02 Prev Nox t Fig 5 6 Technical Screen 5 Zero calibration is required as part of the installation process for the device following replacement of the Sensor PCB F710512 Motherboard PCB F 720510 Control PCB F 710510 or when performance testing indicates that it may be necessary Note Before proceeding with the zero process all pressure including tank pressure should be removed from the system and patient tubing and proximal sensor should be disconnected e Using the rotary control knob locate and sel
151. placed until the replacement part is obtained and compare the two for compatibility if possible Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 123 9 12 Post Repair 9 13 Post Repair Testing 9 14 Repair Documentation 9 15 Patient System amp Accessories After successfully completing any ventilator repair the following should be done prior to returning it to normal operation Visually verify that all pneumatic and electrical parts are properly connected and that all parts are properly installed With a light tug verify that connections are secure and that parts are securely attached Listen for any uncharacteristic sounds pneumatic leaks vibrations grinding etc Be sure that the cooling fan and casters move freely Check for any unusual odours Run the appropriate portions of the Inspiration ventilator performance verification procedure as indicated in section 5 of the before placing the ventilator on a patient Keep a detailed record of all maintenance performed on each device Make sure that service records and other documentation are completed On completion of any ventilator repair run any necessary calibration procedures and any appropriate portions of the Inspiration field check out procedure For detail on the tests which must be performed per repair refer to the table at the beginning of section 6 For convenience a service record sheet has been provided as an appendix to this m
152. r 3 Remove system tubing and verify flow from PV1 4 Perform internal leakage test 5 Replace Sensor PCB 1 Verify internal flow sensor calibration recalibrate as necessary 1 Ensure that patient wye is open at the beginning of system test 2 Verify that PV1 is opening and flow is evident from to patient port 3 Replace Inspiratory Valve PV1 4 Verify no leakage through blender system 1 Ensure that the proximal sensor is connected to the tubing system and that its outlet is open 2 Replace proximal sensor 3 Verify internal flow sensor calibration recalibrate as necessary 4 Verify PV1 calibration recalibrate as necessary 1 Perform re zero of pressure transducers fab test 5 2 Replace Sensor PCB Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 57 Error 14 Deviation High Error 15 Deviation High Error 16 Deviation High Error 17 Deviation High Error 18 Deviation High Error 19 Deviation High Zero Adjustment dP3 Zero Adjustment P3 Differential pressure too low 30 Ipm Differential pressure between Adult Infant limits O 30 Ipm Differential pressure too high 30 lpm Differential pressure too low low flow level 1 Perform re zero of pressure transducers fab test 5 2 Replace Sensor PCB 1 Perform re zero of pressure transducers fab test 5 2 Replace Sensor PCB 1 Ensure that system is leak
153. r 3 3 2 7 Reservoir Over Pressure Valve 3 3 2 8 Blender System Operation Located on Power PCB the reservoir tank pressure transducer P1 monitors the pressure within the reservoir on a continuous basis These measurements will be used by the processor to monitor the reservoir condition and determine when further blending cycles must be initiated The reservoir over pressure valve is incorporated into the top of the gas reservoir The over pressure valve will open in the event of the reservoirs internal pressure exceeding 1 8 bar as might happen in the event of a failure within the blender system regulating the reservoir pressure within a safe level This mechanical relief valve is normally closed by means of a retaining spring mechanism When reservoir system pressure is sufficient to overcome the closing force from the spring the over pressure valve poppet will be lifted from its seat venting excess pressure within the ventilator enclosure Fig 3 11 Reservoir Over Pressure Valve General Operation The frequency of the blending cycles will be dependant upon the amount of gas demanded by current ventilator settings and will be controlled so as to maintain the reservoir pressure within an acceptable operating range The operating pressure range will vary according to what patient type is selected on the device A blending cycle will be initiated whenever the microprocessor determines that there is insufficient gas within the
154. r No 47 Error No 49 Alarm Battery Flat Alarm Occlusion Alarm High Pressure Alarm Internal Pressure Low Disconnect Alarm Low Pressure Alarm Apnea Alarm Low Minute Ventilation Alarm High Minute Ventilation Error No 48 Alarm Disconnection Alarm Low Oxygen Delivery 1 Ensure Air supply is connected and that adequate flow is available or that internal compressor is available and running 2 Ensure 02 Sensor connected correctly 3 Replace 02 Sensor 4 Confirm that inlet check valves CV1 2 are correctly installed and undamaged replace as necessary 5 Replace Sensor PCB 6 Replace 02 Sensor interface block 1 Enter configuration screen 1 and ensure that the oxygen sensor is enabled 1 Ensure Oxygen supply is connected and that adequate flow is available 2 Confirm that inlet check valves CV1 2 are correctly installed and undamaged replace as necessary 3 Confirm operation of the oxygen solenoid replace as necessary Internal rechargeable battery is discharged Pressure at the start of Inspiration is too high Patient system pressure has reached the high pressure alarm setting Internal system reservoir pressure is too low Patient system pressure has not reached low pressure alarm setting during inspiration The apnea interval has elapsed without a patient triggered or mandatory breath being delivered Expiratory minute volume is too
155. ransducers within the pneumatics along with values from a number of electronic circuits FabTest2 lt Inputs gt CHIO Temp Powerboard 2457 mV 37 Cent iarade CHI1 Temp Sensorboard 2607 mu 38 Cent or ade CH12 dP1 Blender 123 mi CH13 P1 Tank 512 mu CH14 10U Cheok 1825 mV Status ADCI CHIS Main Current 644 my 1229 Ok CH16 Charge Current 2168 ml CHIT Grd O mV Status ADC2 CH20 dP2 Valve 738 my 1280 Ob CH21 P2 Valve 1252 mV 22 E Ox 3 2 U Eoen aa Leve cem x A gt pressed keys CH24 Oxygen 607 mV None CH25 Gnd 4095 mi CH26 5U Check 2533 mi CH27 10U Cheok 1925 mu Prev Nox t Fig 5 3 Technical Screen 2 The table provided below lists the A D converter signals along with a more detailed description of each CH10 Temp Powerboard Internal Temperature From Power PCB CH11 Temp Sensorboard Internal Temperature From Sensor PCB CH12 dP1 Blender Blender Flow Sensor FS1 DP1 CH13 P1 Tank Reservoir Pressure P1 CH14 10v Check 10V Supply Monitor CH15 Main Current Main System Current CH16 Charge Current Battery Charging Current CH17 GND Ground CH20 dP2 Valve Delivery Flow Sensor FS2 DP2 CH21 P2 Valve Delivery Pressure Sensor P2 CH22 P3 Proximal Proximal Airway Pressure P3 CH23 dP3 Proximal Proximal Flow Sensor FS3 DP3 CH24 Oxygen 02 Sensor OS CH25 Gnd Ground CH26 5v Check 5V Supply Monitor CH27 10v Check 10V Supply Monitor Additionally using this screen the operation of each of the front panel
156. re closed patient system 2 Run system test with single tubing limb connect between outlet amp exhalation cover 3 Remove system tubing and verify flow from PV1 4 Perform internal leakage test 5 Replace Sensor PCB 1 Forward leak through PV1 valve 2 Forward leak through Solenoid 4 if nebulizer is connected 3 Replace Sensor PCB 1 Ensure closed patient system 2 Run system test with single tubing limb connect between outlet amp exhalation cover 3 Remove system tubing and verify flow from PV1 4 Perform internal leakage test 5 Replace Sensor PCB 1 Verify internal flow sensor calibration recalibrate as necessary 1 Ensure that patient wye is open at the beginning of system test 2 Verify that PV1 is opening and flow is evident from to patient port 3 Replace Inspiratory Valve PV1 4 Verify no leakage through blender system 1 Ensure that the proximal sensor is connected to the tubing system and that its outlet is open 2 Replace proximal sensor 3 Verify internal flow sensor calibration recalibrate as necessary 4 Verify PV1 calibration recalibrate as necessary 1 Perform re zero of pressure transducers fab test 5 2 Replace Sensor PCB 1 Perform re zero of pressure transducers fab test 5 2 Replace Sensor PCB 1 Perform re zero of pressure transducers fab test 5 2 Replace Sensor PCB Inspiration Series Technical Manual F SVSMAN Revision 2
157. reaths then calculate average for the delivered tidal volume Ensure that tidal volume is 100ml 20ml Record result on the final test record Observe and record the reading for respiratory breath rate Reading should be 30bpm 3bpm Record result on the final test record Switch UUT screen to show Monitoring ensure that Vte reading is 100ml 30ml Record result on the final test record On completion press the On Off key and put the device into stand by operation Remove the paediatric tubing system and attach a full adult tubing system including proximal sensor to the device Enter the Calibration menu and perform System Test and Flow Sensor Calibration with the new system attached Configure system as it was previously with proximal sensor connected to high flow inlet Connect an adult test lung to the proximal sensor via a 6mm ET tube Switch device back to the start screen and select Last then Next to enter the proposed settings screen Configure the ventilator as follows and on completion select activate to commence ventilation Respiratory Rate 25bpm Adjust As Required Allow a minimum of 10 breaths for the device to stabilise at the current ventilation settings On the PF300 numerical screen 1 record the measured volume for 5 consecutive breaths then calculate average for the delivered tidal volume Ensure that tidal volume is 300ml 60ml Record result on the f
158. reported with a specific error number to prompt further investigation A full listing of the error codes and appropriate troubleshooting steps is provided at the back of this section The Oxygen sensor calibration will permit the operator to perform a calibration of the integral O2 measurement system prior to use The device will perform a 2 point calibration procedure PV1 will be opened during the calibration to deliver a flow of 30 Ipm and ensure constant draw from the reservoir The reservoir will be replenished initially with 100 oxygen during which the 02 sensor will be monitored for a stable reading Once a stable reading has been acquired the 02 sensor gain will be recorded and stored in NVRAM With 100 calibration completed the flow will be reduced to 21 and the reservoir will then be replenished with 21 oxygen and the sequence will be repeated Note Due to the gas requirements of the Oxygen sensor calibration high pressure Oxygen supply plus an air source high pressure or internal compressor must be connected and available Oxygen sensor calibration may be run as follows e Using the rotary control knob select Oxygen from the available calibrations menu e When ready select Start in order to commence the test procedure e The device will run the 2 point calibration automatically and report an overall pass as OK or a failure with a specific error number to prompt further investigation Insp
159. ressure Oxygen Source External Battery or DC Supply External Battery Charger Extended Ribbon Cable Temperature Drift Fixture JP Touch Up Paint LS PU front Touch Up Paint Chassis Blue Touch Up Paint Chassis White Hand Tools Hexagonal Drivers following sizes 1 5mm 2mm 2 5mm 3mm 4mm 5mm 6mm Torx Drivers following sizes T8 T20 Open End Wrench following sizes 8mm 10mm 14mm 16mm 18mm 19mm 20mm Flat Bladed Screwdriver Philips Screwdriver No 1 2 Static Dissipative Service Kit Cable Ties Small eVent Medical PF300 Biotek 601 Pro or equivalent VBM 54 05 000 or equivalent Local Supply eVent Medical F900085 Local Supply Local Supply eVent Medical F910036 eVent Medical F910265 eVent Medical F910036i eVent Medical F910266 eVent Medical F710214 eVent Medical F710213 eVent Medical F910215 Local Supply Local Supply eVent Medical F710520 eVent Medical F710521 eVent Medical F810225 eVent Medical F721601 eVent Medical F810220 eVent Medical F810222 eVent Medical F810223 Local Supply Local Supply Local Supply Local Supply Local Supply Local Supply Local Supply Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 2 7 Recommended Service Interval Action Required PM Intervals 250 hours or 1 month of use Clean or replaced fan inlet filter P N F910007 PKG 5 Every year or per hospital protocol Electrical Safety Test Every
160. river remove 2 x cap head screw securing the security valve to the top block To remove the Nebulizer valve from the ventilator system us the following procedure Installation should be completed by reversal of the removal procedure Remove the top cover enclosure 9 16 2 Disconnect nebulizer harness from the terminals of the nebulizer valve Using a 14mm open end wrench remove the nut securing the hub magnet of SV4 to the valve body Lift hub magnet off and set aside Using a T8 torx driver remove 2 x CSK screws securing SV4 to the front block To remove the Front Block from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove the top cover enclosure 9 16 2 Remove the nebulizer valve 9 16 29 Using hex driver remove 2 x cap head screws securing the front pneumatic block to the upper pneumatic chassis Using an 18mm open end wrench remove the nebulizer connector from the front block and retain To remove the exhalation valve from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove the top cover enclosure 9 16 2 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 135 Disconnect the exhalation valve at the Power PCB Using hex driver remove 2 x cap head screw securing exhalation cover locking ring in position Set locking ring comp
161. rovide a detailed description of how to configure the Inspiration Ventilators nurse call and serial communication ports For the serial communication interface a full listing is provided for all relevant commands and SNDA responses Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 i Nurse Call Port Configuration The nurse call port allows the Inspiration series ventilator to be connected to a remote alarm system Nurse call pin assignments floating contacts are shown in figure 1 below Pin Function 1 Not in use 2 NC Normal Closed 3 NO Normal Open 4 Not in use Ventilator connector Nurse Call 6 Common 6 Not in use Figure 1 Nurse Call Pin Assignments Serial RS 232 Port Configuration Pin assignments for the Serial RS 232 Port of the Inspiration series ventilator are as shown on figure 2 below RS232 interface pin assignments Pin Function 1 DCD Data Carrier Detect RTS Ready To Send 8 CTS Clear To Send DTR Data Terminal Ready Ventilator connector RS232 GND Ground DSR Data Set Ready RXD Recelve Data 8 TXD Transmit Data DINILAI OJN Figure 2 RS232 Pin Assignments Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 ii Serial RS 232 port setup Serial port parameters for the Inspiration series ventilator are pre configured and may not be adjusted by the user The settings in use are as follows Baud R
162. roximal sensor The differential pressure and resulting reference voltage at dP3 will be recorded and the gain determined The offset and gain data will be stored in NVRAM and used as a look up table during operation to ensure accurate monitoring of exhaled tidal volume Vte As a final step the device will prompt the operator to Block wye then pressurize the system briefly to 30mbar This step provides an offset compensation for the proximal sensing system Note Due to the flow requirements of the calibration at least one high pressure gas source MUST be available and connected to the device Proximal flow sensor calibration may be run as follows e Attach the complete patient tubing system including proximal sensor to the ventilator Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 55 4 3 3 02 Sensor Calibration e Using the rotary control knob select Proximal Sensor from the pull down calibration menu e When ready select Start in order to commence the test procedure e The initial series of tests require the wye piece be left open e After brief pause the device will commence the calibration steps as described above e After the main series of tests have been successfully performed the device will prompt the user to Block Wye in order to complete the final calibration step e On completion of the test the device will report a pass as OK a failure will be
163. rror 20 Deviation High Error 21 Deviation High Error 22 Deviation High Error 23 Deviation High Differential pressure too high low flow level Coefficient a too low Coefficient a too high Coefficient b too low 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet is open 3 Replace proximal sensor 4 Perform re zero of pressure transducers fab test 5 5 Verify internal flow sensor calibration recalibrate as necessary 6 Replace Sensor PCB 1 Ensure that system is leak free by running system test 2 Ensure that the proximal sensor is correctly connected to the tubing system and that its outlet
164. s On the PF300 numerical screen 2 record the measured value of Oxygen Ensure that Oxygen is 30 3 Record result on the final test record Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 98 Switch UUT screen to show Monitoring ensure that devices Oxygen reading is 30 3 Record result on the final test record Operational Test 6 Alarm Operation Make the following adjustments to the ventilator settings Met Voume som E isem oe ae Remove the test lung from tubing system and leave patient wye open to atmosphere Verify that after a number breaths High Priority audible and visual alarms are active Verify that Disconnect alarm message is visible on screen Record on final test record Press audible alarm silence key verify that audible alarm is silenced but alarm LED continues to function Record on final test record Press audible alarm silence key verify that audible alarm functions once more and that LED continues to function Record on final test record Press audible alarm silence once more using a calibrated stop watch verify that alarm remains silenced for 120 seconds 12 following which it functions once more Record on final test record Reconnect patient tubing system to the lung simulator Verify that Disconnect alarm condition auto resets after a number of breaths Record on final test record Remove the lung simulator from patient tubing sys
165. s Technical Manual F SVSMAN Revision 2 0 01 2004 88 6 5 Cleaning and Inspection 6 5 1 Ventilator Set Up 6 5 2 Test Equipment Set Up 6 6 Testing Steps Warning To prevent transmission of disease use personal protective equipment when handling contaminated filters HME s or other patient accessories Caution To prevent damage to ESD sensitive components always follow ESD guidelines when servicing components inside the ventilator Note If you find any problems during the preliminary ventilator inspection correct them before proceeding with the performance verification Failure to correct such problems may affect the remainder of the performance verification procedure Clean and inspect the ventilator as follows e Clean the ventilator exterior e Open up the ventilator and clean its interior using an ESD Safe vacuum cleaner e Remove and inspect the fan inlet filter clean replace as is necessary e Verify the air oxygen fittings and water traps are securely fastened to the ventilator e Visually inspect the ventilators interior and exterior for obvious problems such as missing broken parts loose assemblies disconnected wires connectors or tubes Repair as necessary Connect the ventilator to Air and Oxygen sources and ensure that both have an adjustable output Set the output pressure initially to zero for both air and oxygen To set up your pneumatic test equipment for use during the perfor
166. s comply with the requirements of EN475 the audible signals used are as follows High Priority Alarms Five signals repeated periodically Medium Priority Alarms Three signals repeated periodically Low Priority Alarms One signal repeated periodically Information Messages One signal Alarms can be acoustically silenced for a period of two minutes this is done by pressing the mute key on the front panel of the device Once this time has elapsed the audible alarm will re enunciate During the period where alarm silence is active in the event of any new alarm condition being triggered the alarm silence will be immediately terminated A pre alarm silence function may be switched on by pushing and holding the mute key for a period of three seconds With this function active ALL audible alarms will be silenced for a two minute period Should any alarms occur within this period the Alarm LED will flash according to the priority of the condition and each applicable alarm message will be displayed on the ventilators VGA panel Along with individual audible signals each alarm is easily recognisable by its visual characteristics These are defined as follows Priority Background Audible Alarm LED Nurse Call Can Reset Colour Signal Frequency Status High Red 5 signals 2 0 Hz Enabled No repeated Medium Yellow 3 signals 0 5 Hz Enabled No repeated Low Yellow 1 signal Continuous Enabled No repeated Informative White 1 signal N A Disabled No
167. setting On of Off 6 characters 31 Not used 6 characters Not used 6 characters _____________ amp I 20 21 22 23 24 25 26 27 28 29 O Notused 6 characters S O 55 Not used 6 characters o O 59 Notused 6 characters 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 5 51 52 53 54 56 57 58 69 Notused 6 characters 61 62 63 64 65 7 6 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 71 Flow sensitivity setting 6 characters 72 Not used 6 characters 73 Not used 6 characters 74 Not used 6 characters 75 Not used 6 characters 76 Not used 6 characters 77 Not used 6 characters 78 Not used characters 79 Not used 6 characters Not used Vans 6 characters 81 Not used 6 characters 82 Not used 6 characters 83 Not used 6 characters 84 Not used 6 characters 85 PC inspiratory pressure setting 6 characters Inspiratory time setting 6 characters Not used 6 characters PC apnea pressure setting 6 characters PC apnea rate setting 6 characters PC apnea inspiratory time setting 6 characters PC apnea O2 setting 6 characters 92 Not used 6 characters Not used 6 characters S 100 101 EA 102 lt ETX gt 103 93 94 95 97 72 E 75 701 ae fame 79 so er EEE EE EEE es s 8er 8
168. sure sensor dP2 41 Perform re zero of all pressure out of range transducers 2 Replace Sensor PCB TF22 Technical Fault Not Used Not Used TF23 Technical Fault Not Used Not Used TF24 Technical Fault Software Tasks Corruption 1 Replace Processor PCB TF25 Technical Fault Software Tasks Overflow 1 Replace Processor PCB TF26 Technical Fault NVRAM wrong checksum 1 Clear and test NVRAM then recalibrate device 2 Replace Controller PCB Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 51 TF27 Technical Fault PV1 valve data not valid in 1 Perform calibration of PV1 NURAM 2 Clear and test NVRAM then recalibrate device 3 Replace Controller PCB TF28 Technical Fault Difference between 1 Access Fab Test 2 and verify reading temperature sensors out of from temperature sensors range 2 Replace Sensor PCB 3 Replace Power PCB Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 52 4 3 Self Tests The Self test and calibration routines of the Inspiration Ventilator system may be accessed through the normal start up screen On powering the ventilator on the start up screen Fig 4 2 will offer a CALIBRATIONS option Using the rotary control knob knob select the calibration option in order to access the self testing functions Fig 4 2 Start Up Screen Fig 4 3 below shows the user calibrations screen The calibration screen will permit the
169. t 4 1 Ilil oo 3585 Si o 24V d standby 5V Regulator 5V Standby gt 3 ge S Speaker amp Power on switch Power switch On Off monitor 3 and current measurement Current measurement g To A D Converter gt To MP Master switch 24V f 24V f On Off PP Power amplifier Nurse call relay 15V Regulator 12V DC DC 5V DC DC Converter To PP Converter 24V f a Y 10V reference one a 2 12 12V fi Power i pa E aaa wo errar nni ER g 0 a CPN RES LCD 2 o qua 24V 1 gt o 6 pressure sensors 1 E Master switch Safety switch Nurse call MP From current measurement 24V 9 ai 10 Amplifiers Fan slowifast 1 digital ent pressure ith di pro ri Main processor MP Power ampliflers 24V h Compressor filters A D Serial bus Alarm monitoring 2 Master switch On Off MP and current Converter SPI control limitation for Over voltage mamani Compressor on off and compressor protection Compressor valve on off signals 2 digital 24V 9 2 Temperature Valve signals 2 PWM 5 digital sensors Oszilator Clock Alarm LED MP 2 w 3 e m o Speaker controll Backlight inverter 3 3V DC From PP Push and tum knob 8B parallel Bus 3 Ambient valve converter Speaker Power Amplifiers 9 keys In the 3 3V 12 only valve x lexanscreen PWM proportional Inspiration i LCD To PP gt Gr card EA in the lexanscreen E valve PWM proportional Exha
170. t 103 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 iv 7 3 1 Technical Error Listing 103 7 3 2 Self Test Errors 106 7 3 3 General Operation Errors High Priority 110 7 3 4 General Operation Errors Medium Priority 111 7 3 5 General Operation Errors Information 112 8 Alarm Messages 115 8 1 Introduction 115 8 2 Audible Alarms 115 8 3 Alarm Signals 115 8 4 Alarm Log 115 8 5 High Priority Alarms 116 8 6 Medium Priority Alarms 117 8 7 Low Priority Alarms 118 8 8 Information Messages 118 9 Service And Repair Instructions 121 9 1 Introduction 121 9 2 Repair Safety 121 9 3 Repair Guidelines 121 9 4 Cleaning 122 9 5 Electrical Cables And Pneumatic Connectors 122 9 6 ESD Control 122 9 7 General Information 122 9 8 Procedures And Precautions 122 9 9 Repainting 123 9 1 ONon Conforming Parts 123 9 11 Replacement Parts 123 9 12Post Repair 124 9 13Post Repair Testing 124 9 14 Repair Documentation 124 9 15 Patient System And Accessories 124 9 16 service and Repair Procedures 125 10 Parts List 137 10 1 Introduction 137 10 2 ventilator Assembly 138 10 3 ventilator Accessories 141 10 4 ventilator Chassis 142 10 5 Front Housing Module 143 10 6 Graphic Module 149 10 7 ventilator Housing Assembly 154 10 8 Pneumatic Chassis 158 10 9 Pneumatic Lower Module 160 10 10 Pneumatic Upper Block 162 10 11 Sensor Block1 164 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 v
171. t check valves CV1 2 are correctly installed and undamaged replace as necessary 3 Confirm operation of the oxygen solenoid replace as necessary Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 61 4 4 Configuration Mode 4 4 1 Configuration Mode Entry The user configuration menu permits the operator to configure the device as required for the patient or institutional application The user configuration screens may be accessed as follows With the device switched off press and hold the lt Special gt key first then press and hold in the lt ON OFF gt key to switch on the device On successful entry and completion of POST the configuration entry screen will be visible on the screen 1 Special Push amp Hold Fig 4 4 Configuration Entry Sequence With the configuration start up screen visible select Config from the available options using the rotary control knob knob Once Config has been selected the code entry screen Fig 4 will be visible on the device At the code entry screen select the Code window using the rotary control knob knob and adjust to display the default entry code of 1998 On completion de select the window using rotary control knob knob once more then select OK to proceed to the full configuration mode Note Configuration screen 2 will permit an operator defined entry code to be set for future use Inspiration Series T
172. t up screen will continue to the end and then stall At this time the audible alarm will sound a continuous tone In the event of an error being detected during the last section of Power On Self Test the unit will revert to the normal start up screen and report a technical fault specific to the triggering condition The ventilator will sound the High priority audible alarm signal and the Alarm LED will flash red Fig 4 1 Power On Self Test Screen Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 49 4 2 1 POST Errors In the event of a problem being detected during the self test routines the device on completion of self test will report an error code specific to the triggering condition The respective Technical Fault error codes a definition there of along with possible steps for resolution are listed in the table below TF01 Technical Fault Configuration EEPROM memory defective Configuration EEPROM memory defective Pressure Sensor Gain not valid Sensor PCB EEPROM TF02 Technical Fault TFO3 Technical Fault TF04 Technical Fault Configuration EEPROM memory defective TFO5 Technical Fault NVRAM Defective TF06 Technical Fault Log Book data not valid in NVRAM Pressure sensor offsets not valid in NVRAM TF07 Technical Fault Internal Flow Sensor data in NVRAM not valid TF08 Technical Fault TFO9 Technical Fault Altitude Compensation data
173. te Disconnect high pressure oxygen hose from source and observe device After a number of cycles verify medium priority audible alarm is active and that alarm LED is illuminated Verify that Oxygen Supply alarm message appears in screen area Verify that ventilation continues uninterrupted After an additional number of cycles verify high priority audible alarm is active and that Low Oxygen alarm message is now visible in screen area Verify that ventilation continues uninterrupted Reconnect high pressure oxygen hose to source and verify that alarm conditions auto reset after a number of breaths Disconnect high pressure air hose from source and observe device After a number of cycles verify that compressor system starts Verify that ventilation continues uninterrupted Confirm that the following info messages are displayed FIO2 May Vary Flow Trigger Not Available Reconnect high pressure air source verify that compressor ceases to operate Switch off device and switch back on in configuration menu Enter code to access configuration screen 1 switch compressor back up to off then switch Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 91 device off once more Switch device on and select previous settings to commence ventilation Verify ventilation commences with no alarms Disconnect high pressure air source once more Verify that Air Supply alarm message appears in screen area Verify t
174. tem once more and occlude at wye Verify that after a number of breaths High Priority audible and visual alarms are active once more Verify that High Pressure alarm message is visible on the screen Record on final test record Remove occlusion from the wye and reconnect patient system to the lung simulator Verify that alarm condition auto resets after a number of breaths Select Special menu Apnea Backup and ensure the device is set as follows Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 99 Ventilation Mode PCMV oe ae Return to settings screen and sent unit in Spontaneous Spont Mode Verify that after a period of 60 seconds a high priority audible and visual alarm occurs accompanied by APNEA BACKUP alarm message in the main screen area Verify also that Back Up Apnea Ventilation starts at the parameters previously selected Switch off UUT disconnect high pressure gas sources and set output to off Remove all patient tubing system components from the device Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 100 6 7 Performance Verification Troubleshooting Steps Operational Test Errors Error Description Corrective Action Gas Sources 02 Supply Alarm O2 supply alarm not active 1 Ensure that the 02 supply has been disconnected Compressor Not Compressor not active at removal 1 Ensure that the Compressor bac
175. teries not connected 2 Internal batteries incorrectly connected 3 Internal battery shorted 4 Replace Power PCB Shorted 1 Battery charging circuit damaged Communications This area of the screen will permit the service engineer to view information pertaining to communications between the main system processor Mc and the power interface controller Pic The information available in this areas is as follows e Packages Sent Incremental number denoting the number of data packages exchanged between the power processor PIC containing power status information e Pic Errors Incremental number denoting the number of communication errors detected by the power processor PIC e Mc cmd ack err Incremental number denoting the number package acknowledgement errors detected by the main microprocessor PIC did not send an acknowledgement for a package sent by main processor e Mc checksum err Incremental number denoting the number of checksum errors detected by the main processor Main processor has received a package with a bad checksum e Status Indicates the status of communications between the Pic and the Mc e Master Switch Indicates the condition of the pneumatic master control switch Miscellaneous This area of the screen permits the service engineer to review miscellaneous information pertaining the current condition of the Power control system The information available in this area is as foll
176. ternally in cmH20 and ml Pressure displayed on x axis and volume on the y axis Flow volume loop measured proximally or internally in l sec and ml Flow is displayed on the y axis and volume on the x axis Flow volume loop measured Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 7 2 5 4 AlarmsLimit Settings Resp Rate High max breath rate Resp Rate Low min breath rate Ppeak High maximum pressure Ppeak Low minimum pressure Ve High high exp minute volume Ve Low low exp minute volume Pmean High high mean pressure Pmean Low low mean pressure Vte High high tidal volume Vte Low low tidal volume Vti Limit High high inspired tidal volume limit High Delivered FIO2 Low Delivered FIO2 2 to 200 b min Auto P CMV V CMV set rate 50 All other modes monitored total rate 50 1to 199 b min Auto P CMV V CMV set rate 50 All other modes monitored total rate 50 1to80cmH20 Auto V CMV V SIMV monitored Ppeak 10 cmH20 P CMV P SIMV Pcontrol set PEEP 10cmH20 SPONT SPAP Psupport set PEEP 10cmH20 0 to 79 cmH20 Auto all modes set PEEP 1 cmH20 0 1 to 50 l min Uses inspiratory minute volume Vi if proximal sensor is disabled Auto V CMV mode set rate x set tidal volume 50 All other modes monitored ExpMinVol 50 0 0 to 49 9 l min Uses inspiratory minute volume Vi if proximal sensor is disabled Auto
177. tion Series Technical Manual F SVSMAN Revision 2 0 01 2004 5 Respiratory Rate Tidal Volume Flow Pattern PEEP CPAP Pcontrol Psupport E Ratio Time Plateau Inspiratory Pause Oxygen Pressure Trigger Flow Trigger Exhalation Sensitivity Exh Sens Peak Flow Apnea Time Automode SPAP Mode Settings Phigh Plow Psup High Psup Low Thigh Tlow Infant 1 to 150 b min Pediatric 1 to 120 b min Adult 1 to 60 b min Accuracy 0 1 b min 1 Infant 10 to 100 ml Pediatric 20 to 500 ml Adult 300 to 2000 ml Accuracy 10 to 40ml 2ml 5 Accuracy 41 to 2000ml 10ml 5 Decelerating Decelerating 50 Square 0 to 50 cmH20 Accuracy 2 cmH20 4 0 to 80 cmH20 Accuracy 2 cmH20 2 5 1 9 to 4 1 Accuracy 0 1 2 0 1 to 5 seconds 0 to 70 Accuracy 0 05 seconds 1 21 to 100 FIO2 Accuracy 3 Full Scale 1 to 20 cmH20 Infant 0 5 to 10 I min Pediatric 0 5 to 15 l min Adult 0 5 to 25 l min 10 to 80 of peak flow 1 to 180 Ipm Accuracy 1 to 10 l min 1 l min 10 10 to 180 l min 5 l min 10 10 to 60 seconds Off or On Plow setting to 50 cmH20 0 to 50 cmH20 O to 80 Phigh setting cmH20 O to 80 Plow setting cmH20 0 1 to 60 Tlow setting seconds 0 2 to 59 8 seconds VTV Settings PRVC CMV PRVC SIMV and VS Modes Target Vt Infant 10 to 100 ml Pediatric 40 to 500 ml Adult 300 to 2000 ml I
178. tor Cart Deluxe Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 138 10 2 2 VENTILATOR ASSEMBLY MODEL F7200000 INSPIRATION ST F 7200000 DE F 7200000 ES F 7200000 FR F 7200000 GB F 7200000 IN F 7200000 JP F 7200000 IT F 7200000 PL F 7200000 PT F 7200000 RU F 7200000 US Inspiration Ventilator German Inspiration Ventilator Spanish Inspiration Ventilator French Inspiration Ventilator English UK Inspiration Ventilator English IN Inspiration Ventilator Japanese Inspiration Ventilator Italian Inspiration Ventilator Polish Inspiration Ventilator Portuguese Inspiration Ventilator Russian Inspiration Ventilator US Inspiration Ventilator Cart Standard Inspiration Ventilator Cart Transport Inspiration Ventilator Cart Deluxe Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 10 2 3 VENTILATOR ASSEMBLY MODEL F7100000 remo Ferito Decio F 7100000 DE F 7100000 ES F 7100000 FR F 7100000 GB F 7100000 IN F 7100000 IT F 7100000 PL F 7100000 PT F 7100000 RU Inspiration Ventilator German Inspiration Ventilator Spanish Inspiration Ventilator French Inspiration Ventilator English UK Inspiration Ventilator English Int Inspiration Ventilator Italian Inspiration Ventilator Polish Inspiration Ventilator Portuguese Inspiration Ventilator Russian F 710100 Stand Assembly F 710102 Stand Stay Plate F 710101 Venti
179. tput of the high pressure air source as necessary until a pressure of 800 mbar 10mbar is observed at P1 Tank on screen Using rotary control knob select pressure adjust set point for 800mbar Observe that PV1 PWM value is increased until such Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 77 time that a flow of 1 lpm is detected by the internal flow sensor Proceed only when the device confirms successful calibration at this level e When complete adjust the output of the high pressure air source as necessary until a pressure of 1300 mbar 10mbar is observed at P1 Tank on screen e Using rotary control knob select pressure adjust set point for 1300mbar Observe that PV1 PWM value is increased until such time that a flow of 1 Ipm is detected by the internal flow sensor e On successful completion of the calibration switch off the pneumatics and reduce output of high pressure air source to 0 5 3 10 Screen 10 Fab Test 10 Fig 5 11 will allow the trained service technician Screen 10 Blender Test to evaluate the function of the Internal blending system of the Inspiration ventilator The following settings may be defined FabTest10 Blender Settings Measurement s Uxwcer E x A 102 Status stor Pi Tank 152 mbar pu Pi Tank Max 8 mbar 0 dy Pi Tank Mint mbar Tair O ms TO2 8 ms Adu Blender flow 7 ml s mbar Flow Rir O mids gt Flow 021 mids Stop i Oxyge
180. troller PCB and place into static shielding bag Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 127 9 16 9 Inverter PCB Removal Installation LS ST Only 9 16 10 Power Converter PCB Removal Installation LS Only 9 16 11 Controller PCB Removal Installation To remove the Inverter PCB from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove top cover enclosure 9 16 2 and place on static dissipative mat if Inspiration LS separate PU front bezel from front housing 9 16 3 Remove Graphic module and LCD display panel 9 16 7 Carefully disconnect the red inverter ribbon cable from the Inverter PCB Using a 2 5mm hex driver remove 2 x cap head screw securing the Inverter PCB to the Controller PCB graphic plate Set the Inverter PCB aside and place into a static shielding bag To remove the Power Converter PCB from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove top cover enclosure 9 16 2 and place on static dissipative mat if Inspiration LS separate PU front bezel from front housing 9 16 3 Remove Graphic module and LCD display panel 9 16 7 Using a 2 0mm hex driver remove 2 x cap head screw securing the Power Converter PCB to the graphic plate Carefully disconnect the Power Converter PCB from the Graphic PCB and p
181. tute for the exercise of professional judgement The Inspiration ventilator system should be operated and serviced only by trained professionals eVent Medical Ltd s sole responsibility with respect to the ventilator and its use is as stated in warranty provided Nothing in this manual shall limit or restrict in any way eVent Medical s right to revise or otherwise change or modify the equipment including its software described herein without notice In the absence of an express written agreement to the contrary eVent Medical Ltd has no obligation to furnish any such revisions changes or modifications to the owner or user of the equipment including its software described herein 1 3 Definitions Throughout this manual three types of indicator are to be used in order to convey information in regard to the remaining dangers associated with the proper use of the Inspiration series ventilator system and emphasize important technical requirements WARNING Means that there is a possibility of injury to yourself or other persons CAUTION Means that there is a possibility of damage to the equipment or other property NOTE Indicates a point of particular interest or special emphasis for more efficient and convenient operation of the equipment 1 4 Product Warranty The Inspiration series ventilator system is warranted against defects in material and workmanship in accordance with eVent Medical Equipment Warranty for a period of one y
182. ure that each of the five casters has its brake engaged Using a 6mm hex driver remove the 4 CSK screws securing the 2 x mounting rails to the ventilator chassis Support the rail and sleeve during the removal of each screw Set components aside Lift the top cover from the rear and rotate slowly forward to allow access to the inside of the front bezel Disconnect the ribbon cable running from Controller PCB at the Power PCB end Disconnect internal Ethernet cable at the Power PCB end Disconnect the single spade ground cable from the front bezel Following removal place the top cover enclosure on to a grounded static dissipative mat or into a static shielding bag To remove the PU front bezel from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Ensure that the front housing is placed onto a secure flat surface Using a 2 5mm hex driver remove the 4 x CSK screws securing the PU front bezel to the front housing Grab PU front bezel lift and rotate forward from the top Reach inside and disconnect 2 x ground cables at the front housing Carefully lift the PU front bezel up and clear of the front housing disengaging the hinges Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 125 9 16 4 Rotary control knob Removal Installation 9 16 5 Mini Web Interface PCB Removal Installation 9 16 6 Processor PCB Removal I
183. vice via the Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 3 serial port the power cord should be in place so as to ensure proper grounding 24 Product The Inspiration ventilator system is intended for use with a wide range of Description infant through adult patients requiring ventilatory and or respiratory support The ventilator system has a built in compressor and internal rechargeable battery and is therefore not dependent on an external power or air supply for operation As such it can be used to provide ventilation during patient transport within the hospital The Inspiration ventilator system is well equipped with ventilatory monitoring and safety features Listed below are some of the device s key features e Inspired oxygen levels at the user s desired concentration e Volume or pressure based breaths delivered in a controlled synchronized intermittent mandatory or spontaneous mode Flow or pressure triggering of breaths e Apnea monitoring and ventilation back up system e Numeric or Waveform display of user defined ventilator data e Respiratory Mechanics monitoring e Smart Sighs at user desired frequency and breath amplitude e User defined Smart Nebulizer functions e Prioritized alarm system Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 4 2 5 Product Specifications 2 5 1 Power and gas supply AC input Power consumption D
184. with gateway details required for local or LAN connection to the devices Access Code Permits the user to define a password to be used when making connection to the mini web interface Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 65 Fig 4 8 Configuration Screen 3 Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 66 5 5 1 Introduction 5 2 Accessing amp Navigating Engineering Functions 5 3 Technical Screens 5 3 1 Screen 1 Output Tests Service Mode Fab Tests This section of the Inspiration series ventilator service manual is intended to provide the trained technician with details of how to access and use the fabrication screens as a means of testing and troubleshooting the system Note For reasons of patient safety service screens may not be entered while ventilation is in progress If service screens must be accessed the patient must be removed from the ventilator and the unit should be switched off The service screens are accessed by power firstly power cycling the ventilator Immediately after the device has been switched the technician should simultaneously press lt Man Insp gt and lt Nebulizer gt keys as shown in Fig 5 1 and the first technical screen will be displayed Nebulizer Man Insp Fig 5 1 Accessing Service Functions There are a total of 13 screens within the service mode of the Inspiration ventilator
185. ws securing the blender valve to the blender block Inspiration Series Technical Manual F SVSMAN Revision 2 0 01 2004 133 9 16 26 Removal Of Inspiration Valve Assembly 9 16 27 Removal Of Internal Flow sensor 9 16 28 Removal Of The Security Block 9 16 29 Removal Of The Over Pressure Valve To remove the Inspiration Valve from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Note Observe and note the orientation of Inspiration valve prior to removal Valve body must be oriented such that surface stamped with an arrow faces front of the device Remove the top cover enclosure 9 16 2 Remove the compressor platform 9 16 13 Disconnect main pneumatic harness from the Inspiratory valve PV1 Using a 14mm open end wrench remove the nut securing the hub magnet of PV1 to the valve body lift hub magnet off and set aside Using a T20 torx driver remove 2 x CSK screws securing PV1 to the sensor block 1 To remove the Internal Flow Sensor from the ventilator system use the following procedure Installation should be completed by reversal of the removal procedure Remove the top cover enclosure 9 16 2 Remove the compressor platform 9 16 13 Using 2 5mm hex driver remove 2 x cap head screw securing the internal flow sensor between sensor blocks 1 and 2 Firmly grip flow sensor handle and slide the component up and out from

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