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SC430 User Manual-AV-S

1. leelele es 51 Setting the High and Low O2Alarms 51 USER MAINTENANCE Service Schedule eee 52 Cleamidg ooooc n 52 Outside Surfaces ww kk ess 52 Bellows and Diaphragm Exhalation Valve 53 Spirometer Sensors ww llle 54 Patient Connector Block o oooooooooocco siira 55 SIeriliSationi s a io a qaa seu aa dud oda ee 56 Oxygen Monitor Cleaning and Sterilisation 57 Oxygen Sensor Replacement 57 APPENDIX 1 Backup Battery sesso xta EVER ER mmis 58 2 Menu SYSISM gt iudex es dee kad Aa e e Rd Packet xe aea RR a danas 59 3 Ventilator Spirometry System _ sss 62 iv USER RESPONSIBILITY This anaesthesia ventilator has been built to conform with the specification and operating procedures stated in this manual and or accompanying labels and notices when checked assembled operated maintained and serviced in accordance with these instructions To ensure the safety of this device it must be checked and serviced to at least the minimum standards laid out in this manual A defective or suspected defective product must not under any circumstances be used The user must accept responsibility for any malfunction which results from non compliance with the servicing requirements detailed in this manual Additionally the user must accep
2. T Press the menu switch 5 and select the O2 monitor sub menu 8 Scroll to CALIBRATION If the menu shows 21 which indicates calibration using air press the navigator wheel button 6 to switch to 100 calibration using oxygen 9 A message will flash on the screen 02 AT 100 Press the button 5 to confirm 02 Monitor 8 Spiro NOTE The message OXYGEN SENSOR LOW OUTPUT ESO PE ROM VENG will appear on screen if the user attempts to O2 MONITOR on calibrate at 21 in 100 oxygen CALIBRATION 100 HIGH ALARM SET 105 10 Scroll to ESCAPE FROM MENUS and press LOW ALARM SET 18 the button 6 to exit SPIROMETER on 11 Turn off the flow of oxygen SPIRO CALIBRATION 0 L min 12 Refit the absorbent canister 1 50 PRE OPERATION PROCEDURES O2 Monitor 5 3 3 Sensor Low Indication The unit automatically detects when sensor life is low The message OXYGEN SENSOR LOW OUTPUT will appear on screen to indicate that the sensor must be replaced The sensor output will fall very quickly to zero over a period of two to three weeks from the first time that the alarm is activated Sensor replacement see section 6 5 5 3 4 Setting the O2 Alarms 5 3 4 1 Set High Alarm The high alarm value cannot be set below 19 or above 105 Note that in certain conditions of excess pressure the readout may show a value above 100 1 Touch the O2 concentration display or Press the menu switch on the ventil
3. Turn the AV S on at the ventilator Do not use the Prima SP Gas Delivery switch Or Disconnect the fresh gas hose from the CGO block on the anaesthetic machine Remove the breathing circuit hoses from the inspiratory and expiratory connectors 1 on the absorber Disconnect the hose that connects the APL valve outlet 2 at the rear of the manifold block to the AGSS receiver or disconnect at receiver a Remove the bag and set the Bag Vent control 3 to Bag position or b Ensure that the ventilator bellows is empty Calibrate the spirometer via the ventilator menu procedure Press the menu switch on the front panel Scroll down the main menu and select O2 MONITOR amp SPIROMETRY Select SPIRO CALIBRATION Press the wheel to initiate calibration Calibration is completed Scroll to ESCAPE FROM MENUS Press the wheel to confirm 43 On Off Switch Alarm Mute Menu Switch Navigator Wheel and Press Button O2 Monitor amp Spiro ESCAPE FROM MENU O2 MONITOR on CALIBRATION 10096 HIGH ALARM SET 105 LOW ALARM SET 18 SPIROMETER on SPIRO CALIBRATION 0 L min PRE OPERATION PROCEDURES 5 1 11 Pressure Monitor Connections WARNING The High and Low Airway Pressure Alarms are important for patient care The connection point must be properly located in the expiratory limb of the breathing system 1 PATIENT PR
4. 1 All selection or changes in the menu are followed by a CONFIRM message prompt on the screen and accompanied by a BEEP user volume set The selected text or option will invert in colour User settings menus only activate in Standby mode Clock menu Upgrade menu Diagnostic menu only activate in Standby mode Special Modes on screen tab only activates in Spontaneous mode Adult default settings VT 600 mL RATE 10 bpm IE RATIO 1 2 Plimit 38 cmH20 Ptarget 10 cmH20 Paediatric default settings VT 150 ml RATE 15 BPM IE RATIO 1 2 Plimit 38 cmH20 Ptarget 10 cmH2O 59 Menu Structure Main Menu EXIT MENUS 02 MONITOR 8 SPIROMETRY FRESH GAS COMPENSATION ON SPECIAL MODES WAVEFORM ALARM SETTINGS GAS MIXTURE O2 AIR USER SETTINGS SERVICE MENU 02 Monitor amp Spirometry ESCAPE FROM MENU 02 MONITOR on CALIBRATION 100 HIGH ALARM SET 105 LOW ALARM SET 18 SPIROMETER on SPIRO CALIBRATION 0 L min off on Toggle option 21 10096 Toggle option 19 105 Integer 18 99 Integer off on 0 L min 10 L min Toggle option A Fresh Gas Compensation ON OFF off on Toggle option Support Mode pick list Special Modes none pressure ESCAPE FROM MENU SUPPORT MODE none Sag TRIGGER 5 L min Trigger pick list SIGH TO BREATH RATIO 1 50 0 2 Lmin Sigh to Breath a L min Ratio pick list 0 4 L min 1 50 0 5 L min 2 50 1 0
5. O2 Monitor 3 12 4 Display High set low set and oxygen concentration percentage readings are displayed on screen Touch the tab to activate O2 menu Oxygen Concentration The display provides a direct readout of measured oxygen concentrations in the range 0 100 Low Alarm Set limited within 18 99 The oxygen percentage set by the user at which the low alarm will be activated To set the low oxygen alarm see section 5 3 4 High Alarm Set limited within 19 105 The oxygen percentage set by the user which the high alarm will be activated Note that in certain conditions of excess pressure the readout may show a value above 100 To set the high alarm see section 5 3 4 3 12 5 Display HIGH O2 ALARM The high O2 alarm is triggered when the oxygen concentration is 196 above the set value a The High O2 Alarm visual indicator will illuminate b Ahigh priority audible alarm will sound To cancel this alarm the high alarm setting must be equal to or above the oxygen concentration The alarm can be muted for 120 seconds LOW O2 ALARM The low alarm is triggered when the oxygen concentration is 196 below the set value a The Low O2 Alarm visual indicator will illuminate b Ahigh priority audible alarm will sound To cancel this alarm the low alarm setting must be equal to or below the oxygen concentration The alarm can be muted for 120 seconds O2 SENSOR FAULT The alarm is triggered i
6. On a regular basis in line with hospital procedures for infection control the patient block 1 must be removed cleaned and sterilised 1 Detach the hoses from the outlets 2 Note different diameters for correct refitment Undo the securing knobs 3 Carefully detach the assembly 1 from the control unit Note that resistance will be felt until the metal tubes 4 disengage Wash thoroughly then sterilise as recommended in section 6 3 Do not disassemble Refitting 5 Position the patient block and push fully into the control unit ensuring that the metal tubes 4 are engaged in their unions Fit the securing knobs 3 Function test the ventilator Oteo due iEo 55 USER MAINTENANCE 6 3 Sterilisation Recommended guidelines for sterilisation CAUTION To prevent possible damage to components peak sterilisation temperatures must not exceed 540C 1300F for gas ethylene oxide or 1349 C 2750F for steam autoclave Note low temperature autoclave is 1219C Do not sterilise the ventilator control unit The internal components are not compatible with sterilisation techniques and may be damaged Following sterilisation with ethylene oxide components must be quarantined in a well ventilated area to allow dissipation of any residual gases Follow the recommendations given by the steriliser manufacturer for aeration periods requ
7. showing typical hysteresis between up and down flow measurements and repeatability Resistance cmH20 4 5 3 5 2 5 15 0 5 20 40 64 60 80 Flow L min 100 120 140 Paragon Service W Bennet Sreet Saline MI 48176 Doc No A2 0105UI July 2005 Manufactured by Penlon Limited Abingdon UK
8. cmH50 38 Pmean mH20 10 Standby Navigator Wheel and Press Button Turn the wheel to select a function or parameter or to alter the value of an active parameter Press to confirm the setting 3 5 1 2 Selecting Functions and Parameters The functions parameters shown on the Screen can be activated as follows a touch the screen at the appropriate tab area b rotate the navigator wheel and press it when the indicator arrow is on the required parameter tab Note that parameters default to factory set values when the ventilator is switched on and no further user selection is made 3 5 1 3 User Adjustable Parameters Variable parameters can be altered by rotating the navigator wheel When the required value is displayed press the active tab or the wheel to confirm the setting DESCRIPTION 3 5 2 User Adjustable Parameters Tidal Volume Range 20 1600 ml Rate 4 100 bpm E Ratio 1 0 3 to 1 8 PEEP 4 30 cmH20 Can be set to OFF Pressure Limit Volume mode 10 80 cmH20 Pressure mode 10 70 cmH20 3 5 3 Operational Capability Tidal Volume Rate and E ratio settings are all limited by a maximum inspiratory flow of 75 L min Tidal Volume litres Vt LE Ratio 1 6 15 1 4 1 3 1 2 1 1 1 0 3 0 10 20 30 40 50 60 70 Rate bpm The ventilator is capable of operating at the volumes and rates below each I E ratio curve Example 1 Select required volume Vt e g 0 8 L 2 Selec
9. this ventilator WARNINGS General Information 1 Personnel must make themselves familiar with the contenis of this manual and the machine s function before using the ventilator Before Using the Ventilator 2 Before the ventilator is used clinically for the first time verify that the hospital engineering department has carried out an earth continuity test Excessive electronic noise caused by other poorly regulated devices such as an electrocautery unit may adversely interfere with the proper functioning of the ventilator To avoid this problem do not connect the ventilator s power cord into the same electrical wall outlet or adaptor strip into which an electrocautery unit is connected If used with a mains extension cord the unit may be subject to electro magnetic interference The driving gas supply must be clean and dry to prevent ventilator malfunction This ventilator is designed to be driven by oxygen or medical air only It is calibrated during manufacture for use with either gas Before the ventilator is used clinically for the first time the commissioning engineer must confirm that the internal Air Oxygen switch is set correctly for the gas that is to be used The use of any other gas will cause inaccurate operation and may damage the ventilator resulting in potential injury to the patient 10 The driving gas is discharged through the opening in the back of the ventilator control uni
10. The inside of the bellows housing under normal conditions is not in contact with the breathing gas and therefore only needs cleaning as described above Remove the bellows housing A by slightly twisting it counter clockwise until the tabs at the bottom clear the bayonet locks then lift it straight up from the base Touchscreen Use a soft cloth only Never use any harsh abrasive cleaning agent USER MAINTENANCE 6 2 2 Bellows and exhalation diaphragm valve Each time the bellows assemblies are opened for cleaning all visible components must be carefully inspected and damaged parts must be replaced Bellows As with all elastomers the bellows material deteriorates with aging and should be inspected at least every six months or after 1200 hours of use whichever comes first The bellows must be replaced if it shows signs of aging The bellows B can be removed by carefully pulling it off the base If a paediatric bellows is fitted the bellows adaptor C must also be removed Do not dismantle the bellows Exhalation Diaphragm Valve The exhalation diaphragm valve is under the bellows and can be removed by loosening the three thumbscrews The valve seat is now visible WARNING Great care must be taken Do not damage the precision surface of the valve seat D Never use any hard object or abrasive agent to clean it use only a soft cloth If the valve seat is damaged the diaphragm valve will leak an
11. generate a more than 0 5 cmH20 positive or negative pressure k when connected to the ventilator A I Any problem arising from an improperly functioning scavenging system is solely the user s responsibility 5 1 7 Remote Screen Attach the DVI cable supplied with the screen between the interface connectors 1 on the rear of the control unit and screen WARNING Check that the cable between the control unit and remote display screen unit is securely connected before use Always use a cable type recommended by the manufacturer CELLEEEELLLDS 0 Eo po SE 5 1 8 Printer Attach a printer to the printer port 2 if a printed output of the ventilator function is required 41 PRE OPERATION PROCEDURES 5 1 9 Breathing System 1 Connect the ventilator bellows base BREATHING SYSTEM port to the breathing system 2 a Use a breathing system bacterial filter in the expiratory limb of the breathing circuit to protect the oxygen sensor b Use a heat and moisture exchanger HME at the patient Y piece CAUTION Replacement Disposal always follow the instructions supplied with the filter or HME Fit new components at the recommended interval 3 Connect a 2 litre breathing bag to the patient connection as a test lung 4 Close the anaesthetic machine APL valve 5 1 10 Spirometer 5 1 10 1 Flow sensors fitted to an A200SP Absorber mounted on a PrimaSP2
12. must be charged before the machine is released for use with an 14 hour charge from the ventilator s internal power supply ventilator connected to the mains supply but not running Note that the mains power indicator on the front panel will show a yellow light during charging Subsequently the recharge periods for a battery on a ventilator in store are similar to those in B below Batteries in machines in normal use will be kept charged by the internal power supply Note that the Low Battery Alarm indicator may be displayed if automatic recharging is taking place as the ventilator is in use B Battery care storage requirements During storage batteries will require a periodic recharge the frequency of which is determined by the storage temperature which must not exceed 50 C 120 F Storage Recharge temperature period 38 to 509C 100 to 1229F 1 month 21 to 38 C 70 to 100 C 3 months 7 to 21 F 45 to 70 F 6 months 0 to 79C 32 to 45 F 9 months 5 to 0 C 23 to 32 F 12 months Duration recharge until the charge current is less than 25 mA typically overnight It is recommended that at each charge an updated label is affixed to the unit to indicate date of the last charge C Disposal of used batteries Follow all hospital local state and federal regulations Note Removal replacement of battery must only be undertaken by a trained technician 58 APPENDIX APPENDIX 2 On screen Menus NOTE
13. show that the battery is being charged it is not necessary to turn on the ventilator Ventilator internal test Press the ON OFF switch 1 A three second internal test is initiated 1 The power up screen is displayed 2 The audible alarm sounds 3 The ventilator reverts to STANDBY mode if no selection is made NOTE special operating system on ventilators interfaced with Prima SP2 see section 3 5 2 a Turn the anaesthetic machine Gas Delivery Switch to ON the ventilator will power up b While machine power is ON the Ventilator can be turned OFF and ON using the ventilator On Off switch c Turn the machine Gas Delivery Switch to OFF The ventilator will power down Calibrate the Spirometer 5 1 9 2 Calibrate the O2 Monitor 5 3 2 46 Function Test Set the AIRWAY PRESSURE LIMIT to 50 cmH20 PRESSURE TRANSDUCER connection Check that the port on the rear of the control unit is correctly connected to the port on the rear of the absorber assembly see section 5 1 10 Connect a 2 litre breathing bag to the patient connection as a test lung Adult bellows only Set the tidal VOLUME to 600 ml RATE to 10 bpm and 1 E RATIO to 1 2 0 Use the O2 flush button on the anaesthetic machine to fill the bellows Select VOLUME CYCLE mode The delivered tidal volume indicated on the scale printed on the bellows housing should be approximately 600 ml If the delivered tidal volume is l
14. the mode previously set by the user PEEP is Off PEEP display indicates Off 5 Set ventilator to Volume Ventilation Mode PEEP remains Off Select PEEP if required 25 DESCRIPTION 3 8 On Screen Menus To Access Press the menu switch on the front panel to access the following functions and parameters via drop down menus EXIT MENUS O2 MONITOR amp SPIROMETRY FRESH GAS COMPENSATION ON SPECIAL MODES WAVEFORM ALARM SETTINGS GAS MIXTURE 02 AIR USER SETTINGS SERVICE MENU Menu Switch Turn the wheel To Exit to scroll through Press the menu switch on the front panel or the menus select EXIT MENUS and press the wheel Press to enter sub menu NOTE The menu window will not be displayed if A Control parameters Vr MEAS BPM EE PEEP or LIMIT are enabled but not confirmed B A display window is active To Operate 1 Rotate the navigator wheel clockwise to scroll through the menu options the cursor aligns with each parameter in turn 2 Press the wheel to enter the required sub menu 3 Rotate the navigator wheel to change any displayed values and press to confirm 4 Toexit the menu display A Press the menu switch on the front panel B Scroll to EXIT MENUS and press the navigator wheel NOTE A If confirmation does not take place within 8 seconds the parameter reverts to its previous value B f another parameter is selected using the touchsc
15. when either the oxygen sensor is disconnected or approaching the end of its life ii if the O2 concentration exceeds 110 a The message O2 SENSOR FAULT will be displayed 31 Measured O2 concentration High Alarm Set Value Low Alarm Set Value b A high priority audible alarm will sound To cancel this alarm check the sensor connection or replace the sensor The alarm can be muted for 120 seconds 02 SENSOR LOW This alarm indicates the sensor has approached the end of its life The legend O2 SENSOR LOW will be displayed and a low priority alarm single note will sound The sensor must be replaced as the output will fall very quickly to zero within two to three weeks of normal usage See section 6 5 for sensor replacement 3 12 6 Oxygen Monitor Alarm Mute In an alarm condition pressing the ALARM MUTE button will deactivate the audible alarm but the alarm message display will remain on screen The switch will illuminate and a single note will sound The alarm mute can not be operated a Until the mute time is over or the alarm condition has been rectified b When O2 concentration drops below 18 4 SPECIFICATION 4 1 Application 4 2 Internal Compliance Adult bellows Paediatric bellows 4 3 Physical Size mm control unit only with adult bellows Screen Size Weight control unit only with adult bellows Bellows Adult Latex free Paediatric Ventilatio
16. 1 Use a breathing system bacterial filter see section 5 1 9 operation 2 CAUTION Replacement Disposal always follow the instructions supplied with the filter Always renew components at the recommended interval 2 The two spirometry flow sensors are mounted within the A200SP Absorber in the inspiratory and expiratory airways 3 Connect the cable assembly between the connector at the rear of the A200SP Absorber A and the the socket B at the rear of the Ventilator control unit 4 Check that the cable connections are secure NOTE A Ifthe connections are incorrectly made the ventilator will alarm LOW TIDAL VOLUME or HIGH TIDAL VOLUME B To allow the ventilator to be used in the event of damage or non functioning of the spirometer heads turn off the spirometry function see MENU function section 3 5 If the spirometer is switched OFF a Fresh gas compensation is disabled b Fresh gas mixture compensation is disabled c Patient support function is disabled 42 PRE OPERATION PROCEDURES 5 1 10 2 Spirometer Calibration Flow sensors fitted to an A200SP Absorber mounted on a Prima SP2 The Spirometry heads must be calibrated with zero flow going through them 1 10 11 12 13 Turn the Prima SP gas flow off at the Gas Delivery on off switch This will stop all gas flows including the AHD basal flow This will also turn the AV S off
17. E POLSKI ESPANOL Serial mode pick list NONE Philips SPACELABS Clock ESCAPE FROM MENU YEAR 2005 2005 2099 MONTH 3 1 12 DATE 16 1 31 DOW 3 1 7 1 Monday HOUR 9 0 23 MINUTE 57 0 59 UPDATE CLOCK DAYLIGHT SAVING off Clock pick list off on Upgrade ESCAPE FROM MENU 1 0 HARDWARE 2 1 0 FIRMWARE v0 47 Build 68 MAIN FIRMWARE v0 92 Build 32 REGISTRATION KEY unknown UPGRADE FIRMWARE unavailable ADD NEW FEATURE unavailable History Display ESCAPE FROM MENU MANUFACTURER DATE 03 03 05 TOTAL HOURS RUN 100 LAST SERVICE DATE 13 08 04 HOURS SINCE SERVICE 100 DRIVE VALVE CYCLES 1253 PATIENT VALVE CYCLES 822 CUTOFF VALVE CYCLES 72 Sub menus are not accessible by users 61 integer integer integer integer integer integer toggle option APPENDIX APPENDIX 3 AV S Ventilator Spirometry System Ventilator Spirometry Measurement The AV S ventilator drive gas and spirometry system uses a total of three mass flow gas sensors to monitor and then independently measure the gas flows within the ventilator and breathing system This ensures that correct volumes are delivered to the patient These monitors are measuring firstly in the ventilator delivery control system and secondly in the patient breathing system During use of the ventilator the user will set a required tidal volume and at the first breath the ventilator will use ts pre calibrated del
18. ESSURE port A on the rear panel of the control unit Use the tubing assembly supplied by the manufacturer to connect to the expiratory limb of the breathing system close to the circle system expiratory valve 2 Push fit self sealing connectors B Push in the tube as far as possible Do not use excessive force The connector end piece X will also move inwards Pull the tube carefully outwards The end piece X will be pulled outwards to the locked position 3 Connect the tubing with adaptor Part No 053049 to the push fit self sealing connector C at the rear of the A200SP Absorber 44 PRE OPERATION PROCEDURES 5 1 12 Bellows Assemblies CAUTION Always ensure correct fitment of bellows see illustration above and carry out a full function test before clinical use if a bellows is removed and refitted 1 NOTE Remove the bellows housing 1 Twist carefully counterclockwise until the bayonet tabs become free then lift up from the base 2 Remove the bellows 3 Refit the bellows and check for correct assembly as illustrated 4 Fit the bellows housing by pushing down then twisting clockwise until the bayonet tabs completely engage Function test the ventilator section 5 3 1 If there is any malfunction the ventilator must NOT be used If the problem cannot be rectified the ventilator must be checked by an engineer trained by the man
19. EXIT MENUS and press the wheel to exit NOTE The oxygen monitor automatically switches ON and defaults to the previous values for high and low alarm settings when the ventilator is switched on Fresh gas mixture compensation is disabled if the O2 monitor is switched OFF CALIBRATION Press the navigator wheel to initiate the calibration procedure see section 5 3 2 for full procedure To exit the menu scroll to EXIT MENUS and press the wheel HIGH ALARM SET LOW ALARM SET Scroll to the required parameter and press the navigator wheel to activate Rotate the navigator wheel again to change the displayed value see section 5 3 4 for full procedure 19 to 105 18 to 99 High Alarm range Low Alarm range The displayed figure will flash on and off Press to confirm Scroll to EXIT MENUS and press the wheel to exit O Monitor sub menu O2 Monitor amp Spiro ESCAPE FROM MENU O2 MONITOR on CALIBRATION 10096 HIGH ALARM SET 105 LOW ALARM SET 18 SPIROMETER on SPIRO CALIBRATION 0 L min O Monitor sub menu calibration O2 Monitor amp Spiro ESCAPE FROM MENU O2 MONITOR on CALIBRATION 10096 HIGH ALARM SET 105 LOW ALARM SET 18 SPIROMETER on SPIRO CALIBRATION 0 L min O2 Monitor sub menu alarms O2 Monitor amp Spiro ESCAPE FROM MENU O2 MONITOR on CALIBRATION 100 HIGH ALARM SET 105 LOW ALARM SET 18 SPIROMETER on SPIRO CALIBRATION 0 L min DESCRIPTION
20. ION 3 7 6 PEEP Positive End Expiratory Pressure The AV S ventilator includes a microprocessor controlled electronically integrated PEEP system regulated using secondary pressure on the exhaust diaphragm The ventilator controls PEEP by allowing flow from or delivering flow into the bellows drive circuit maintaining pressure PEEP is electronically controlled Variable from 4 30 cmH20 in increments of 1 cmH2O Clear OFF indication when not in use Switch off the ventilator PEEP is switched off PEEP is switched off during Spont mode to minimise patient s breathing effort Selecting PEEP Select by touching the screen tab PEEP or using the navigator wheel The setting will flash Rotate the navigator wheel to set the required PEEP pressure A confirm message will be displayed Press the Screen Tab or Wheel to confirm Note that Electronic PEEP does not function in Spontaneous Mode PEEP on off sequence Using the A200SP Absorber Interface Ventilator Mode Selection 1 Ventilator is in Volume Ventilation Mode 2 PEEP selected pressure set to required level PEEP display indicates pressure 3 A200SP Absorber Bag Vent control A is moved to Bag position Ventilator automatically switches to Spontaneous Mode PEEP is automatically switched off does not function in Spontaneous Mode PEEP display is blank 4 Bag Vent control reset to Vent position Ventilator automatically switches to
21. L min 3 50 1 5 L min 4 50 2 0 L min 2 5 L min 3 0 L min 4 0 L min Waveform ESCAPE FROM MENU SECOND WAVEFORM off Second waveform pick list off vol vs time vol vs press Alarm settings ALARM MENU ESCAPE FROM MENU ALARM MODE default default user Toggle option HIGH TIDAL VOLUME off off on Toggle option VM MIN 0 3 L 0 0 7 4 Integer VM MAX 0 9 L 0 1 7 5 Integer VT MIN 300 mL 10 1600 Integer VT MAX 900 mL 20 2400 Integer APNOEA ALARM LIMIT 0 3 cmH20 0 3 3 5 Integer ALARM VOLUME 50 50 100 Integer Gas mixture O2 Air O2 AIR O2 N2O O2 Xe O2 He User Settings ESCAPE FROM MENU SELECT SETTINGS SAVE SETTINGS BACK LIGHT LEVEL 50 VOLUME TYPE tidal Select settings ESCAPE FROM MENU USER1 CCT1 USER2 CCT2 USER3 CCT3 USER4 CCT4 USERS CCT5 ADULT DEFAULT PAEDIATRIC DEFAULT Save settings ESCAPE FROM MENU USER1 CCT1 CONFIRM CCT1 USER2 CCT2 CONFIRM CCT2 USER3 CCT3 CONFIRM CCT3 USER4 CCT4 CONFIRM CCT4 USER5 CCT5 CONFIRM CCT5 Backlight level 0 100 integer Toggle option Volume type Service tidal minute toggle See next page 60 Service ESCAPE FROM MENU LANGUAGE ENGLISH PRINT PATIENT DATA SERIAL MODE none CLOCK MENU UPGRADE MENU AMBIENT PRESSURE 988 mBar DISPLAY HISTORY SERVIS PIN 0 ENGINEER MENU NOTE Service PIN Engineer Menu Language pick list ENGLISH ITALIANO TURKC
22. NING The sensor 1 contains A A small quantity of electrolyte classified as a harmful irritant which is potentially hazardous B Lead Do not attempt to open a cell ALWAYS check the integrity of the sensor assembly before use Once exhausted the sensor must be disposed of according to hospital local state and federal regulations 6 5 1 Sensor Expiry Date The approximate expiry date is marked on the sensor label using two boxes which represent the year and month Thus on a sensor marked as below the approximate expiry date is the end of December 2006 YR0123 45 K7 89 MIHUFMAMJJASONX 6 5 2 Sensor Unit Remove and Refit Replacement parts 102714 Sensor includes flow diverter and O rings Detach the cable connector A from the sensor B Unscrew the sensor from its location Discard the expired sensor and flow diverter C Insert the cable connector into the new sensor B Screw the new flow diverter C onto the new sensor and fit new O rings Fit the assembly into the absorber 7 Calibrate the new sensor see section 5 8 Dispose of the used components according to hospital regulations and relevant national legislation OP oum o 57 7 APPENDIX APPENDIX 1 Care of Back up Battery CAUTION Damage may occur if the battery is allowed to remain in a discharged state Never discharge the battery to below 10 2 volts A Battery installed in ventilator The battery
23. Paragon Draft Copy 2 5 July 2005 No update will be given AV S Ventilator Remote Display Module and Interface for use with A200SP Absorber User Manual IMPORTANT Servicing and Repairs In order to ensure the full operational life of this ventilator servicing by an engineer trained by the manufacturer should be undertaken periodically The ventilator must be serviced to the following schedule a Six monthly service inspection and function testing b Annual service c Five year major service including battery replacement Details of these operations are given in the Service Manual for the AV S available only for engineers trained by the manufacturer For any enquiry regarding the servicing or repair of this product contact Paragon Service Paragon Service W Bennet Sreet Saline MI 48176 Always give as much of the following information as possible Type of equipment Product name Serial number Approximate date of purchase Apparent fault OL ox Wwe FOREWORD This manual has been produced to provide authorised personnel with information on the function routine performance and maintenance checks applicable to the AV S Anaesthesia Ventilator Information contained in this manual is correct at the date of publication The policy of the manufacturer is one of continued improvement to its products Because of this policy the manufacturer reserves the right to make any changes wh
24. aser trimmed thick film and thin film resistors provide consistent interchangeability from one device to the next The microbridge mass airflow sensor uses temperature sensitive resistors deposited within a thin film of silicon nitride They are suspended in the form of two bridges over an etched cavity in the silicon The chip is located in a precisely dimensioned airflow channel to provide a repeatable flow response Highly effective thermal isolation for the heater and sensing resistors is attained by etching the cavity space beneath the flow sensor bridges The small size and thermal isolation of the microbridge mass airflow sensor are responsible for the extremely fast response and high sensitivity to flows APPENDIX Dual Wheatstone bridges control airflow measurement one provides closed loop heater control the other contains the dual sensing elements The heater circuit minimizes shift due to ambient temperature changes by providing an output proportional to mass flow The circuit keeps the heater temperature at a constant differential 160 C above ambient air temperature which is sensed by a heat sunk resistor on the chip The ratiometric voltage output of the device corresponas to the differential voltage across the Wheatstone bridge circuit Sensor flow characteristics The graph shown below is a typical flow versus resistance graph for the Honeywell spirometer head units for the flow range
25. ator front panel and select the O2 monitor sub menu 2 Scroll to HIGH ALARM SET and press the navigator wheel 3 Rotate the wheel to change the displayed alarm figure to the desired value 4 Press the wheel to confirm 5 Scroll to ESCAPE FROM MENUS and press the wheel to exit 5 3 4 2 Set Low Alarm The low alarm value cannot be set lower than 18 or above 99 1 Touch the O2 concentration display or Press the menu switch on the ventilator front panel and select the O2 monitor sub menu 2 Scroll to LOW ALARM SET and press the navigator wheel 3 Rotate the wheel to change the displayed alarm figure to the desired value 4 Press the wheel to confirm 5 Scroll to ESCAPE FROM MENUS and press the wheel to exit 51 High Alarm Set Value 02 100 21 12 Low Alarm Set Value O2 Monitor amp Spiro ESCAPE FROM MENU O2 MONITOR on CALIBRATION 100 HIGH ALARM SET 105 LOW ALARM SET 18 SPIROMETER on SPIRO CALIBRATION 0 L min A On Off Switch Alarm Mute Menu Switch Navigator Wheel and Press Button 6 USER MAINTENANCE 6 1 Service Schedule At 6 months 12 months 2 years and 4 years the ventilator must be serviced by an engineer trained by the manufacturer following the schedule given below and the procedures given in the AV S Service Manual Every day Pre use function check Every week Check the condition of the bellows assembly diaphragm val
26. ays follow the instructions supplied with the filter and always replace at the recommended interval 5 3 2 Calibration The new unit must be calibrated before clinical use Thereafter as a safety precaution we recommend calibration of the unit every time the system is switched on Calibration must also be performed A when the sensor is replaced B when point of use elevation changes by more than 160 m 500 ft We recommend calibration with a 10096 oxygen standard source at a pressure and flow similar to your application 49 PRE OPERATION PROCEDURES O2 Monitor 5 3 2 1 Calibration Using 100 Oxygen AV S ventilator mounted on a Prima SP2 anaesthetic machine fitted with a A200SP absorber Calibrate with the sensor in position within the absorber 1 Detach the absorbent canister 1 2 Remove the breathing circuit hoses from the inspiratory and expiratory connectors 2 on the absorber This will give a free flow of oxygen through the sensor 3 Switch on the ventilator 3 and the anaesthetic machine gas delivery switch The oxygen monitor automatically switches ON when the ventilator is switched on Ensure that all vaporizers are OFF 4 Apply 10096 oxygen only at 5 L min from the anaesthetic machine flowmeter 5 Allow the oxygen to flow until the oxygen monitor readout 4 stabilises 6 Calibrate the sensor using the AV S ventilator menu procedure as follows
27. c patients Inspiratory pressure 10 70 cmH20 Rate 4 100 bpm E ratio 1 0 3 1 8 PEEP Off or adjustable 4 30 cmH20 Inspiratory decelerating flow controlled by the ventilator according to pressure setting No Inspiratory pause function 3 7 3 2 Pressure Mode Operating Functions Defaults to 10 cmH20 Maximum Inspiratory Flow to achieve target pressure Sustaining flow maintains circuit pressure Control achieved using exhaust valve 22 DESCRIPTION 3 7 4 Spontaneous Mode 3 7 4 1 Parameters The ventilator monitors the following patient parameters Rate E ratio Pressure Tidal volume Provides waveform displays Inspiratory oxygen is measured 3 7 4 2 Spontaneous mode operating functions No mechanical ventilation No Inspiratory Pause function Patient Monitoring Bag mode and Ventilator mode Airway pressures FiO2 Vi Rate I E ratio Supply pressures Ventilation conditions Advanced Spontaneous Breathing mode is selectable from this mode see below and section 3 7 5 3 7 4 3 Advanced Spontaneous Breathing Mode Support mode available from Special Mode select from main menu PSV Pressure Support Ventilation see section 3 7 5 The A200SP Absorber Bag Vent control must be in Vent position for this mode to be selected Note that if the system fails to detect an absorber bag vent switch a confirm message will be displayed 23 DESCRIPTION 3 7 5 PSV Pressure Supported Venti
28. d may cause serious malfunction Clean the seat and the metal disk E attached to the base of the diaphragm valve thoroughly and remove all contamination from the surfaces of both components NOTE If excessive contamination is discovered check that a bacterial filter is used in the expiratory limb of the breathing circuit and an HME at the patient tee piece After cleaning check that the small O ring F located in the bellows base under the diaphragm valve is in place The ventilator will not function if the O ring is missing See section 6 5 for information on sterilisation procedures Paediatric Bellows Assembly Exhalation Diaphragm Valve Assembly 53 USER MAINTENANCE Refitting Refit the diaphragm valve assembly to the bellows base and reassemble the bellows assembly see section 5 2 If a paediatric bellows is fitted press the adaptor C into the ventilator bellows assembly base then fit the bellows CAUTION Always check for correct fitment of the bellows see illustration and function test the ventilator before clinical use 6 2 3 Spirometer Sensors The sensors are built into the A200SP absorber and cleaning and sterilisation can only be carried out when the absorber assembly is removed for cleaning For further information please refer to the user instructions supplied with the A200SP 54 USER MAINTENANCE 6 2 4 Control Unit Patient Block Assembly
29. enging transfer and receiver system must conform to ISO 8835 3 Any problem arising from an improperly functioning scavenging system is solely the user s responsibility Do not use a scavenging system that restricts drive gas flow when negative pressure is exerted on it 17 18 19 20 21 22 23 24 When the ventilator is connected to a patient it is recommended that a qualified practitioner is in attendance at all times to react to an alarm or other indication of a problem In compliance with good anaesthesia practice an alternative means of ventilation must be available whenever the ventilator is in use It is recommended that the patient oxygen concentration should be monitored continuously If the drive gas supply pressure drops below a nominal 241 kPa 35 psi the LOW DRIVE GAS SUPPLY alarm will activate both audibly and visually Patient minute volume may be reduced due to lowered flow rates An audible alarm indicates an anomalous condition and should never go unheeded The characteristics of the breathing circuit connected between the ventilator and the patient can modify or change patient ventilation To assist the maintenance of the delivered patient tidal volume the ventilator control system software includes A a compliance compensation algorithm B a fresh gas compensation algorithm However patient ventilation must be monitored independently from the ventilator It
30. ess than 500 ml or greater than 700 ml refer the ventilator to an engineer trained by the manufacturer Set a basal flow only on the anaesthetic machine Check the bellows after 10 breaths the bellows should return to the top of the housing Failure to return to the top of the housing indicates a leak in the breathing circuit Rectify the leak before clinical use Occlude the patient Y piece The HIGH AIRWAY PRESSURE alarm should be activated The peak pressure read on the breathing system pressure gauge is the maximum working airway pressure limit and should agree with the setting 47 10 11 NOTE PRE OPERATION PROCEDURES Open the patient Y piece to ambient pressure At the second cycle the LOW AIRWAY PRESSURE alarm should be activated Select STANDBY mode Before using the ventilator clinically check that all connections are correct and verify that there are no leaks If there is any malfunction the ventilator must NOT be used If the problem cannot be rectified the ventilator must be checked by an engineer trained by the manufacturer PRE OPERATION PROCEDURES 5 2 3 Weekly Checklist At least every week in addition to the daily function test the following checks must be carried out Alarms 1 Select STANDBY MODE 2 Unplug the mains power cable from the AC outlet The MAINS FAILURE alarm should activate 3 Reconnect the mains power cable to the AC outlet The ala
31. ge 45 to 100 psi 3 1 6 9 bar 310 689 kPa OXYGEN SUPPLY a O2 cylinder b Anaesthetic machine O2 auxiliary gas outlet C O2 pipeline supply from a wall outlet AIR SUPPLY a Air cylinder b Anaesthetic machine Air auxiliary gas outlet C Air pipeline supply from a wall outlet Supply pressure should be monitored by a separate means e g pressure gauge on anaesthetic machine or supply line NOTE It is possible to reconfigure the ventilator for use with a different drive gas to the gas originally specified This work must be carried out by an engineer trained by the manufacturer 5 1 4 Breathing System Schematic The following page contains a schematic diagram showing the cables and tubing for an AV S ventilator mounted on a Prima SP2 anaesthetic machine with an integral A200SP Absorber PRE OPERATION PROCEDURES Hoses and Cables Schematic AV S and A200SP Absorber 1 AV S has spirometry and oxygen monitor 2 Interface cabling is shown for Prima SP2 On Off switch and A200SP Bag Vent switch 38 PRE OPERATION PROCEDURES we ov Ou CO P Ro NN mn mm o n ln o c o o o f PON Se Oona Pf ONTO 25 26 27 28 29 30 31 Bellows Ventilator Control Unit Outlets to Anaesthetic Gas Scavenging System AGSS Bacterial Filter Absorber valve block Heat and moisture exchanger Patient CGO Block on anaesthetic machine Fresh Gas Supply Auxiliary Outlet on anaes
32. hetic machine auxiliary gas outlet 2 Bellows Drive Gas Output connect to bellows via A200SP absorber see section 5 1 5 3 Outlet Exhaust Valve Electrical Connection 4 Electrical mains input and fuse unit Interface and Parameter inputs 5 oo A200SP Absorber Bag Vent switch interface Spirometer connector Prima SP2 Interface connector Pressure Monitor Port Input socket Oxygen monitor sensor Data and Printer Ports 9 Data Output 10 Output to remote display 11 Ethernet 12 USB 13 VGA 14 Printer port 15 RS232 NOTE USB port is for access only by engineers trained by the manufacturer All other data ports are read only For further information please contact Paragon DESCRIPTION 3 2 Ventilation Cycle This section provides a simplified description of the ventilation cycle A INCHES 1 Inspiratory Phase y pae The inspiratory proportional qr valve 1 in the control unit I opens and bellows drive 4 x gas is delivered to the i bellows housing 2 The expiratory proportional lt Y nd valve 3 opens and gas i 3 flows through the bleed A RS RENE E valve The back pressure ensures that the exhaust is k aif Er valve 4 is kept closed gt LL Y A Drive gas pressure builds 6 up above the bellows which starts to move down The diaphragm 5 in the bellows assembly base is held closed and patient gas is forced out of the be
33. ich may affect instructions in this manual without giving prior notice Personnel must make themselves familiar with the contents of this manual and the machine s function before using the apparatus THE IMPORTANCE OF PATIENT MONITORING WARNING Anaesthetic systems have the capability to deliver mixtures of gases and vapours to the patient which could cause injury or death unless controlled by a qualified anaesthetist There can be considerable variation in the effect of anaesthetic drugs on individual patients so that the setting and observation of control levels on the anaesthesia systems does not in itself ensure total patient safety Anaesthesia system monitors and patient monitors are very desirable aids for the anaesthetist but are not true clinical monitors as the condition of the patient is also dependent on his respiration and the functioning of his cardio vascular system IT IS ESSENTIAL THAT THESE ELEMENTS ARE MONITORED FREQUENTLY AND REGULARLY AND THAT ANY OBSERVATIONS ARE GIVEN PRECEDENCE OVER MACHINE CONTROL PARAMETERS IN JUDGING THE STATE OF A CLINICAL PROCEDURE CONTENTS 3 1 3 2 3 3 3 3 1 3 4 3 5 3 5 1 3 5 2 3 5 3 3 5 4 3 6 3 7 3 7 1 3 7 2 3 7 3 3 7 4 3 7 5 3 7 6 3 8 3 9 3 10 3 11 3 12 3 12 1 3 12 2 3 12 3 3 12 4 3 12 5 3 12 6 5 1 5 1 1 USER RESPONSIBILITY WARNINGS AND CAUTIONS PURPOSE vaivenes ad
34. idal Volume adjustment Modes Off Standby Volume Cycle Pressure Controlled Spontaneous includes advanced Pressure Support Ventilation Pressure Control 10 70 cmH20 Inspiratory Flow 2 75 L min Spontaneous Mode Active Volume and Pressure Alarms Advanced Breathing Mode selectable see section 4 6 Electronic PEEP 4 30 cmH20 Oxygen Monitor Fuel Cell type For full specification see section 4 15 Spirometry Resolution 1 ml Ventilator Performance accuracy of delivered volumes gt 300 ml 10 gt 100 ml lt 300 ml 20 lt 100 ml 50 NOTE The ventilator is designed for use with Spirometry ON Accuracy of delivered volumes with Spirometry OFF may vary from the figures given above 33 SPECIFICATION 4 6 Advanced Spontaneous Breathing Mode PSV Trigger PEEP Referenced 0 2 to 4 L min Trigger Window Set 60 of Expiratory Time Vt and Vm As Volume Mode Insp Time Ti 0 5 to 5 secs Support Pressure 3 to 20 cmH20 Default settings Volume Adult Paediatric Pressure Adult Paediatric PSV Adult Paediatric 4 7 4 8 4 9 4 10 4 11 4 12 4 13 4 14 Vt BPM EE Pmax 600 ml 10 1 2 38 cmH20 150 ml 15 1 2 38 cmH20 Vt BPM I E P target 600 ml 10 1 2 10 cmH20 150 ml 15 1 2 10 cmH20 Support Pressure Insp time 10 cmH20 0 4 L min 10 cmH20 0 4 L min Disinfection and Sterilisation Bellows base assembly Patient Block assembly and inside of bellows can be sterilised if necessary secti
35. ime Static with single beep sound 30 seconds for high priority alarm 120 seconds for medium priority alarm 18 99 1 19 105 1 2 m 6 ft fully extended Galvanic fuel cell sensor 0 100 1500000 O2 hours One year minimum in typical applications Interference Gases and Vapours in 30 Oxygen 70 Nitrous Oxide Interference Nitrous Oxide Carbon Dioxide Halothane Enflurane Isoflurane Sevoflurane Volume Dry Interference in 02 80 lt 1 5 lt 1 5 lt 1 5 lt 1 5 lt 1 5 lt 1 35 SPECIFICATION O2 Monitor Oxygen Monitor continued Humidity Effects Sensor output is relatively unaffected by prolonged operation in either high or very low relative humidity If the sensor shows signs of being affected by condensation dry the sensor with soft tissue CAUTION DO NOT use heat to dry the sensor Temperature Effects The sensor has a built in temperature compensation circuit and is relatively unaffected by temperature changes within the operating temperature range given above Pressure Effects The sensor measures O2 partial pressure and its output will rise and fall due to pressure change e g changes in barometric pressure or breathing system pressure An increase in pressure of 1096 at the sensor inlet will produce a 1096 increase in sensor output 36 5 PRE OPERATION PROCEDURES 5 1 5 1 1 Ventilator Set up Mounting the Ventilator The remote screen is moun
36. ing If the internal battery is fully discharged the ventilator will not function in the event of mains power failure The battery must be recharged before the ventilator is used clinically otherwise backup cannot be guaranteed See Appendix for battery maintenance See also CAUTION No 7 Used or defective batteries must be disposed of according to hospital local state and federal regulations No oil grease or other flammable lubricant or sealant must be used on any part of the ventilator in close proximity to medical gas distribution components There is a risk of fire or explosion 31 Exterior panels must not be removed by unauthorised personnel and the apparatus must not be operated with such panels missing There is a possible electric shock hazard Bellows Assembly 32 The valve seat on the patient gas exhalation diaphragm valve in the base of the bellows assembly must be cleaned regularly see section 6 2 Failure to keep the valve seat clean could result in the diaphragm sticking thus preventing exhalation Great care must be taken not to damage the precision surface of the valve seat on the patient gas exhalation diaphragm valve in the base of the bellows assembly Never use any hard object or abrasive detergent to clean it use only a soft cloth If the valve seat is damaged the valve will leak and may cause serious ventilator malfunction WARNINGS AND CAUTIONS CAUTIONS 1 Do
37. ion Modes Volume Mode continuous mandatory ventilation Pressure Mode pressure controlled ventilation Spontaneous with advanced PSV Pressure Support Mode PEEP Patient Monitoring Airway pressure measured from the expiratory limb of the breathing circuit Tidal volume and Minute Volume measurement is provided by a dual spirometry system An integral oxygen monitor system measures oxygen concentration in the breathing circuit inspiratory limb The print function provides a permanent record of function activity for up to eight hours during a procedure or can be used to record waveforms Screen 210 mm 8 4 inch high definition colour TFT screen with single dual waveform display Remote mounted on an arm DESCRIPTION Bellows unit The bellows unit 1 is built into the A200SP absorber A paediatric bellows assembly is available as an option Mounting options The AV S integral screen and control unit can be mounted securely on the anaesthetic machine shelf or side bracket Drive gas supply The supply must be at 310 to 689 kPa 45 to 100 psi The ventilator drive gas supply can be oxygen or air Note that the drive gas is specified by the customer prior to delivery Conversion from one drive gas to another must be carried out by a service engineer trained by the manufacturer DESCRIPTION Control Unit Rear Panel Gas Connections 1 Ventilator drive gas inlet connect to anaest
38. ired ITEM METHOD Bellows Gas liquid autoclave 20 cycles max Hoses Gas liquid autoclave O rings Gas liquid autoclave Bellows base Gas liquid autoclave Exhalation valve Gas liquid pasteurise low temperature assembly autoclave Control unit Do not sterilise remove patient block Patient Block Autoclave Bellows canister Liquid autoclave Oxygen monitor including sensor see section 6 4 NOTE 1 Liquid method indicates the use of a high level disinfectant 2 Examples of suitable high level disinfection liquid agents are Nu Cidex Sporicidin and Sonacide 3 The exhalation diaphragm valve must be removed cleaned and sterilised separately 56 USER MAINTENANCE 6 4 Oxygen Monitor Sensor Cleaning Disinfection Sterilisation In case of contamination the sensor may be cleaned with distilled water and allowed to dry naturally CAUTION The sensor is not suitable for sterilisation by steam or exposure to chemicals such as ethylene oxide or hydrogen peroxide Do not immerse the sensor in any cleaning solution Do not autoclave or expose the sensor to high temperatures Bacterial Filter Use a breathing system bacterial filter in the expiratory limb of the breathing circuit to protect the oxygen sensor see section 5 1 8 CAUTION Replacement Disposal always follow the instructions supplied with the filter and always replace at the recommended interval 6 5 Oxygen Sensor Replacement WAR
39. is the responsibility of the user to monitor patient ventilation Care must be taken to ensure that the flow sensors are connected correctly to the inspiratory and expiratory ports of the absorber The Vent Inop ventilator inoperative alarm indicates that one of the following conditions has occurred a The drive gas solenoid has failed b The flow control valve has failed c Internal electronic fault d Internal electrical fault e Software error WARNINGS AND CAUTIONS 25 26 Note that if a ventilator error is detected Ventilator Inoperative will be displayed on the front control panel display The High and Low Airway Pressure Alarms are important for patient care It is important that the sensor is properly located in the expiratory limb of the circuit refer to section 5 1 10 The patient must be continuously attended and monitored when Advanced Breathing Modes are in use User Maintenance Control Unit 27 28 29 30 Opening the control unit by unauthorised personnel automatically voids all warranties and specifications Prevention of tampering with the control unit is exclusively the user s responsibility If the control unit seal is broken the manufacturer assumes no liability for any malfunction or failure of the ventilator For continued protection against fire hazards replace the two fuses only with the identical type and rating of fuse See section 4 for fuse rat
40. ivery flow rate valve settings to set the proportional delivery valve position to deliver the requested tidal volume To confirm that the correct flow rate tidal volume is being delivered by the ventilator delivery system an internal flow sensor a Honeywell AWM43300V mass flow sensor monitors the delivered flow rate and makes adjustments every 30 ms using proportional regulation As this sensor is always measuring the known drive gas rather than breathing system gas the volumes measured will always be independent of breathing system gas composition This system ensures accurate delivery volume from the ventilator control unit To monitor for correct delivery volumes in the breathing system there are two breathing system mass flow sensors Honeywell AWM 720P1 spirometers One sensor is located in the inspiratory limb and one in the expiratory limb Measurements are taken from these sensors to determine the actual delivered and exhaled gas volumes in the breathing system This enable measurements to be made to compensate for fresh gas flow compliance losses and possible breathing system leaks During the inspiratory cycle the inspiratory flow sensor measures the gas volume delivered to the patient 62 The flow sensor output is read at least every 2 msec and then five sets of readings are averaged and the averaged value is sent every 10 ms to the processor for calculation of the volume delivered to the patient This deli
41. l not measure exhaled volumes in that position WARNINGS AND CAUTIONS 11 12 13 The operation of each alarm function should be verified daily Periodically check the alarms at clinically suitable intervals If the audible alarm or the visual indicator of any alarm function fails to activate during any alarm condition or fails to reset after the alarm has been cleared refer the unit to an authorised service technician Before using the ventilator check that all connections are correct and verify that there are no leaks Patient circuit disconnects are a hazard to the patient Extreme care should be taken to prevent such occurrences It is recommended that Safelock fittings are used throughout the breathing circuit Check that the cable between the control unit and remote display screen unit is connected before use Always use a cable type recommended by the manufacturer Using the Ventilator 14 15 16 The AV S ventilator is not intended for use in intensive care applications This apparatus must not be used with or in close proximity to flammable anaesthetic agents There is a possible fire or explosion hazard Anaesthesia apparatus must be connected to an anaesthetic gas scavenging system AGSS to dispose of waste gas and prevent possible health hazards to operating room staff This requirement must be observed during test procedures as well as during use with a patient The scav
42. lation PSV assists each spontaneous breath to achieve a preset pressure thus reducing the effort required to breathe Inspiratory flow generated by the patient s spontaneous breath results in synchronised pressure support PEEP 0 cmH20 PSV is used to support spontaneously breathing patients ONLY If the patient makes no attempt to breathe the ventilator will not provide support and the apnoea alarm will be LL o n activated B Pressure Support Level C Spontaneous Breath results in a synchronised pressure supported breath PSV Selection Select Standby Mode Select Menu Select Special Modes Select PSV PSV is now indicated on the main screen in Spontaneous mode NOTE 1 The trigger window is pre set to 60 of the BPM cycle time 2 The trigger pressure is PEEP referenced 3 If the Spirometry is disabled then PSV is not available 4 Ifthe pressure limit and alarm are activated the inspiratory phase is terminated PSV Default Settings The ventilator will default to the settings shown in the table after selecting PSV Default Settings PSV from Spontaneous Mode Nota that Support Pressure can be Adult Paediatric Overall range adjusted before PSV is confirmed P Supp 10 cmH20 10 cmH20 3 20 cmH20 Insp Ti 2 sec 1 sec I E display box Trigger setting defaults to 0 4 litres min Trigger level 0 4 L min 0 4 L min 0 2 to 1 0 L min and is adjustable between 0 2 and 1 0 litres min 24 DESCRIPT
43. ll oxygen concentration and the majority of the remaining gas composition APPENDIX Altitude Effects Gas flow measurements are also affected by atmospheric pressure in a linear relationship To compensate for altitude effects an ambient pressure sensor is available When the spirometers are calibrated for zero flow the ambient pressure is recorded so that the measured volume may be adjusted The measured volume is multiplied by the ratio of Pamb to Pcal where Pamb is the latest ambient pressure and Pcal is the ambient pressure recorded when the spirometers were calibrated at zero flow Carrier Gas Effects The effect of air as the dilutent gas is different to that of nitrous oxide and as the ventilator includes only an oxygen monitor the additional information of gas being ventilated is included to increase available accuracy In the event of the wrong gas selection being made by the user the error in delivered volume could reach up to approximately 7 This possible variation is of no known clinical disadvantage Anaesthetic Agent Effects The addition of anaesthetic agent is known also to increase the spirometry readings depending on the agent and its concentration by up to approximately 296 Again this minor volume measurement variation is of no known clinical disadvantage and is therefore not compensated for other than that due to oxygen variation due to the percentage change Water Vapour Effects Water vapour v
44. llows base 6 into the breathing system 2 Beginning of Expiratory Phase The Inspiratory 1 and Expiratory 3 proportional valves close and the exhaust valve 4 opens Patient gas returns to the bellows As the bellows rises redundant drive gas is pushed out through the exhaust valve 11 DESCRIPTION 3 End of Expiratory Phase With the bellows at the top of its housing fresh gas continues to flow To prevent a high pressure build up the exhalation diaphragm 5 lifts and allows gas to exit through the exhaust valve 4 4 PEEP Positive End Expiratory Pressure user selectable During PEEP the Exhalation Proportional valve 3 applies PEEP pressure plus 20 cmH20 to the exhaust valve which remains closed at this stage As fresh gas flows in the patient circuit any pressure increase above PEEP pressure in the bellows will cause gas to bleed past the exhaust valve 4 A continuous flow from the Inspiratory proportional valve 1 ensures that any fall in pressure is compensated by driving the bellows as required DESCRIPTION A Pneumatic Flow Diagram 0 90 cmH20 DESCRIPTION 3 3 Pneumatic System 3 3 1 System Operation Refer to the pneumatic system diagram on the previous page A Gas inlet manifold block The AV S Ventilator is designed to operate on a 310 689 kPa 45 100 psi drive gas supply Oxygen or air
45. mpensation Monitors ambient pressure Adjusts delivered volume accordingly 3 7 2 2 Operating Functions Inspiratory Pause function Creates 25 plateau Sigh function When the ventilator is in Volume Cycle mode the sigh option is available When selected this option provides extra volume for 1 to 4 breaths in 50 frequency is user selectable The extra volume will be 5096 above the tidal volume set by the user Volumes measured if Spirometry function selected Auto High and Low volume alarms if measured volume different by 5096 of set volume User adjustable option If max pressure limit achieved ventilator cycles to expiratory phase 3 7 2 3 Volume Type Selection Use the menu to switch between Tidal Volume and Minute Volume NOTE Minute Volume is derived from a rolling average during a 30 second period Volume Mode Parameters 20 1600 mL 4 100 bpm 1 0 3 1 8 4 30 cmH20 10 80 cmH20 25 Tidal volume Rate LE ratio PEEP Off or adjustable Inspiratory pressure limit Inspiratory pause does not affect I E ratio Sigh 1 5 x Set Vt is delivered once twice three times or four times every 50 breaths user selects frequency 21 DESCRIPTION 3 7 3 Pressure Mode 3 7 3 1 Parameters The ventilator delivers a volume of gas to achieve a set pressure at fixed breath intervals The Patient is making no respiratory effort This is a common mode for the ventilation of small paediatri
46. n for use in anaesthesia 3 ml cmH20 nominal 2 ml cmH20 nominal 290 wide x 300 deep x 185 high 290 wide x 300 deep x 385 high 210 mm 8 4 TFT 7 6 kg 9 kg 20 ml 1600 ml 20 350 ml Note latex free paediatric available as option Power Battery Back up Drive Gas 4 4 Alarms Alarm Mute Low Drive Gas Pressure High Continuous Airway Pressure Low Pressure Low Tidal Volume Incorrect Rate or Ratio Mains Failure Low Battery Ventilator Inoperative Alarms User Set Vt Tidal Min Max Vm Minute Min Max Apnoea Low and High O2 Concentration High Airway Pressure 90 264 VAC 47 63 Hz 30 minutes assumes fully charged battery Oxygen or Air dry and oil free at 45 to 100 psi 310 to 689 kPa 30 or 120 seconds see 3 11 Less than 235 kPa 35 psi Above 30 cmH20 at start of cycle 4 14 cmH20 PEEP referenced 50 of Volume set Spirometry 30 minutes nominal Battery Backup 5 minutes Use Internal or Battery Failure 0 1600 ml 20 1600 ml 0 10L 0 30L Adjustable Re set Pressure PEEP referenced 1896 105 10 80 cmH20 adjustable 32 SPECIFICATION 4 5 Functional Tidal Volume Adult bellows 20 to 1600 ml 10 Paediatric bellows 20 to 350 ml 10 At ambient temperature of 200C 10 and ambient atmosphere of 101 3 kPa 10 Minute Volume 0 to 30 L Rate 4 100 bpm 1 E Ratio 1 0 3 1 8 Pressure Limit 10 80 cmH20 Fresh Gas Compensation Automatic T
47. not sterilise the ventilator control unit The patient block assembly must be removed from the control unit before sterilisation see section 6 2 4 All other internal components are not compatible with sterilisation techniques and damage may result 2 For ventilator components which require sterilisation peak sterilisation temperatures should not exceed 136 C 275 F to prevent possible damage See section 6 3 Those parts suitable for ethylene oxide sterilisation should following sterilisation be quarantined in a well ventilated area to allow dissipation of residual gas absorbed by the components Follow the steriliser manufacturer s recommendations for any special aeration periods required 4 The exhalation valve located in the bellows base assembly and the paediatric bellows adaptor must be cleaned and sterilised separately See section 6 5 Care must be taken not to let any liquid run into the control unit serious damage may result 6 Always check for correct fitment and carry out a full function test before clinical use if the bellows has been removed and refitted for any reason See section 6 7 Damage may occur to the battery if it is allowed to remain in a discharged state Check the battery frequently if the ventilator is in storage see Appendix 1 8 Fresh gas compensation is disabled if a The spirometry system is turned OFF through the menu system or b The spirometry system is not func
48. nsor is not compatible with other sterilisation techniques damage may result Do not sterilise any other components Do not autoclave or expose the sensor to high temperatures If the sensor shows signs of being affected by condensation dry the sensor with soft tissue Do not use heat to dry the sensor NOTES 1 The O2 SENSOR FAULT alarm indicates that one of the following conditions has occurred a Internal electrical fault b Software electronics fault c Oxygen sensor fault The concentration read out may in certain conditions of excess pressure show a value above 100 To accommodate these conditions it is possible to set the high alarm value up to 105 see section 5 To maintain maximum sensor life i always switch off the anaesthetic machine after use to ensure that the basal flow ceases ii disconnect the breathing circuit after use The accuracy of flow and volume measurements may be reduced if the oxygen monitor is not in use Fresh gas mixture compensation is disabled if the oxygen monitor is switched OFF 2 PURPOSE The AV S Ventilator is a software controlled multi mode ventilator designed for mechanical ventilation of adult and paediatric patients under general anaesthesia In addition in spontaneous mode it can be used to monitor spontaneously breathing patients It is designed for use in closed circuit anaesthesia and also to drive a Mapleson D circuit Indications fo
49. nulator usse eae qudd ne erue ioi a aided paki a Ru Oxygen Monitor asiana s a llle ee PRE OPERATION PROCEDURES Ventilator Set up ooocccooco nh Mounting the Ventilator liliis II iii Page No 14 14 15 16 16 17 17 18 19 20 20 21 22 23 24 25 26 27 27 28 CONTENTS 5 1 2 5 1 3 5 1 4 5 1 5 5 1 6 5 1 7 5 1 8 5 1 9 5 1 10 5 1 11 5 2 5 2 1 5 2 2 5 2 3 5 3 5 3 1 5 3 2 5 3 3 5 3 4 6 1 6 2 6 2 1 6 2 2 6 2 3 6 2 4 6 3 6 4 6 5 Electrical Power Connections 37 Ventilator Gas Supply kee 37 Breathing System Schematic 37 Bellows Drive Gas estat Shae dea dew bbe a e DC oce Gees 39 Anaesthetic Gas Scavenging System 41 xii rr a AAA ae ee NS oe ee ee 3 0 0 a 41 Breathing System ere 41 Spirometer Connections lille 42 Pressure Monitor Connections lllllel een 44 Bellows Assembly uuu hem edt eed eo ees 45 Pre use Checklists 46 Daily Checklist sico da pea a S Gg E ERG ee ks 46 FUNCION Test usus garde kasu a aa 47 Weekly Ghecklist iwas s suggetti iai e IA e E E A dos 48 Oxygen Monitor Set up 49 Installatlon 2 ear RA etre RA qo Re RUN 8 3 nana q ds Geek 49 Galibrallon caian das a Oe eee RR aa e ad CAO d Linn n RC RA 49 Sensor Low Indication
50. o remote display 11 Ethernet 12 USB 13 VGA 14 Printer port 15 RS232 NOTE USB port is for access only by engineers trained by the manufacturer All other data ports are read only For further information please contact Paragon PRE OPERATION PROCEDURES 5 1 5 Bellows drive gas hose 1 Prima SP2 with A200SP absorber Connect a 16 mm diameter corrugated hose between the ventilator control unit drive gas outlet labelled DRIVE GAS and the outlet 1 at the rear of the A200SP absorber 2 All other AV S configurations Connect a 16 mm diameter corrugated hose between the control unit drive gas outlet labelled DRIVE GAS and the bellows base DRIVE GAS inlet port 5 1 6 Anaesthetic Gas Scavenging System 1 Connect the EXHAUST valve port on the control unit to a properly functioning scavenging system Usea 19 mm hose 2 Fita 10 cmH20 pressure relief valve between the exhaust valve port and the inlet port of the AGSS receiver Note that the diaphragm valve under the bellows is connected internally to the EXHAUST port to facilitate the discharge of excess breathing gas at the end the expiratory phase WARNING Do not use a scavenging system that restricts drive gas flow when negative pressure is exerted on it Applying negative or positive pressure to the bellows exhaust port results in positive pressure in the patient breathing system Y LAA e Therefore the scavenging system must not
51. olumes in the breathing gas are not detectable in normal breathing System dynamics Additional Features Additional spirometry features available for selection by the user are the ability to turn off the automatic compliance and fresh gas compensation and also the feedback provided by the oxygen monitor In this event the ventilator relies on the basic delivery look up table and the internal flow sensor to confirm delivery volumes as 63 near as possible under the circumstances Accuracies for spirometry measurement are 2300 ml 1096 2100 ml 300 ml 2096 100 ml 50 Flow sensor description The microbridge mass airflow sensor operates on the theory of heat transfer Mass airflow is directed across the surface of the sensing elements Output voltage varies in proportion to the mass air or other gas flow through the inlet and outlet ports of the package The specially designed housing precisely directs and controls the airflow across the microstructure sense element The microbridge mass airflow sensor has a unique silicon chip based on advanced microstructure technology It consists of a thin film thermally isolated bridge structure containing heater and temperature sensing elements The bridge structure provides a sensitive and fast response to the flow of air or other gas over the chip Dual sensing elements positioned on both sides of a central heating element indicate flow direction as well as flow rate L
52. ompensation is disabled if a The spirometry system is turned OFF through the menu system or b The spirometry system is not functioning correctly If the O2 monitor is switched OFF a 4096 6096 mixture of O2 N2O is assumed Altitude Compensation Monitors ambient pressure Adjusts delivered volume accordingly 18 DESCRIPTION 3 6 Interface to Prima SP2 and A200SP The AV S is designed to interface with the Prima SP2 Anaesthetic Machine and the A200SP Absorber 3 6 1 Prima SP2 Interface The interface cable links the socket A on the control panel to a socket on the rear panel of the anaesthetic machine a Turn the anaesthetic machine Gas Delivery Switch to ON The ventilator will power up b While the anaesthetic machine power is ON the Ventilator can be turned OFF and ON using the ventilator On Off switch as described in section 3 5 1 c Turn the anaesthetic machine Gas Delivery Switch to OFF The ventilator will power down 3 6 2 A200SP Absorber Interface The interface cable links the socket B on the control panel to a socket C at the rear of the absorber a The A200SP is fitted with fitted with a sensor that detects the position of the absorber bag vent control D The sensor signal cabling is routed internally to connector C and a second cable runs to the the rear of the AV S control unit b Operation of the Bag Vent control will trigger automatic Mode switching on the AV S ventilator a
53. on 6 Bacterial Filter None see section 5 1 4 use a bacterial filter in the breathing system to protect components that are not autoclavable e g oxygen sensor Fail Safe Mechanism Battery back up in case of mains electricity failure Gas shut off in the event of electronic failure Reliability MTBF 5x106 to 50x108 cycles Waveform Tests Not applicable Volume Tests Not applicable Mobility and Mounting A Mobility Secure mounting required B Mounting Control unit and remote screen are mounted on anaesthetic machine The bellows assembly is built into the A200SP Absorber Fuse mains supply Two fuses Type T 2AH 2A 250 V rating 20 mm anti surge ceramic 34 SPECIFICATION O2 Monitor 4 15 Oxygen Monitor Measurement Range Resolution Accuracy and Linearity Response Time Operating Temperature Storage Temperature Relative Humidity Range Battery Back up Sensor Type High Priority Alarm Medium Priority Alarm Low Priority Alarm Alarm Mute Low Alarm Set Range High Alarm Set Range Cable length Sensor Type Life 0 100 11 12 of full scale at constant temperature and pressure 90 of final value in approx 10 seconds air to 100 O2 50 F to 100 F 10 C to 38 C 23 F to 122 F 5 C to 50 C 5 95 non condensing As per ventilator MOX 3 galvanic fuel cell Flashing 5 audio pulses with 6 seconds repeat time Flashing 3 audio pulses with 24 seconds repeat t
54. r use of the device The AV S Ventilator is intended to provide continuous mechanical ventilatory support during anaesthesia The ventilator is a restricted medical device intended for use by qualified trained personnel under the direction of a physician Specifically the ventilator is applicable for adult and paediatric patients The ventilator is intended for use by health care providers i e Physicians Nurses and Technicians with patients during general anaesthesia The AV S ventilator is not intended for use in intensive care applications Oxygen Monitor The Oxygen Monitor is intended to continuously measure and display the concentration of oxygen in breathing gas mixtures used in anaesthesia and is intended for adult and paediatric patients The oxygen monitor is an integral part of the ventilator The oxygen monitor is intended for use by health care providers i e Physicians Nurses and Technicians for use with patients during general anaesthesia 3 DESCRIPTION 3 1 General Description The AV S Ventilator is a pneumatically driven software controlled multi mode ventilator The ventilator is a time cycled volume pressure controlled and pressure limited The ventilator has compliance compensation and a user selectable option of an inspiratory pause fixed at 25 of the inspiratory time In addition fresh gas compensation and user selectable gas mixture compensation is a standard feature Ventilat
55. reen the menu is de selected C While any menu is selected the alarms are active the ventilator can be switched off See Appendix 2 for a full description of the Menu system 26 DESCRIPTION 3 9 Spirometry Spirometry can be enabled or disabled via the on screen menu system NOTE If the spirometry system is turned OFF a Fresh gas fresh gas mixture compensation is disabled b Special Mode is disabled See Appendix 3 for a detailed description of the spirometry system 3 10 Display Waveforms Default waveform is always Pressure v Time cmH20 v seconds Wave Freeze is available when ventilation is in progress Second waveform A second waveform can be displayed by using menu control or touch waveform on screen The second waveform is selectable Volume v Time litres v seconds Volume v Pressure litres v cmH2O Compliance loop waveform First loop can be frozen Subsequent loops overlaid Display Functions Automatic Scale adjustment Y axis a Scale adjusts as Plimit is changed 20 to 40 60 80 cmH20 b In Vol v Time mode as Vt is changed 0 to 0 5 L 1 0 L 2 0 L X axis a Scale adjusts as Rate is changed 0 to 15 sec 5 sec 3 sec b In Vol v Pres mode as Plimit is changed 20 to 40 60 80 cmH20 27 DESCRIPTION Alarms 3 11 pejeeda euo ajBuiS ony ony olny ony ony jnejeq Jasn yinejeq Jesn ynejaq J sn jnejeq Jesn ony ynejeq J8
56. rm should turn off 4 Disconnect the drive gas supply hose The LOW SUPPLY PRESSURE alarm should activate NOTE If there is any malfunction the ventilator must NOT be used If the problem cannot be rectified the ventilator must be checked by an engineer trained by the manufacturer Bellows Check the condition of the bellows and exhalation diaphragm valve see section 6 2 2 48 PRE OPERATION PROCEDURES 02 Monitor 5 3 02 Monitor System Set up 5 3 1 Installation Fit the probe A to the A200SP absorber Connect the cable to the input socket B on the back of the AV S ventilator control unit NOTE The anaesthetic machine gas control switch must be in the ON position for gas delivery WARNING The sensor contains a small quantity of electrolyte classified as a harmful irritant which is potentially hazardous Do not attempt to open a cell ALWAYS check the integrity of the sensor assembly before use Once exhausted the sensor must be disposed of according to hospital local state and federal regulations NOTE To maintain maximum sensor life i always disconnect the breathing circuit after use ii Switch off the anaesthetic machine to cut off the basal flow through the system Bacterial Filter Use a breathing system bacterial filter in the expiratory limb of the breathing circuit to protect the oxygen sensor see section 5 1 8 CAUTION Replacement Disposal alw
57. s DESCRIPTION General lt iiiourrriViarr re UO a id Ventilation Cycle 2 0 0 0 0c rs Pneumatic System System Operation ss sanaa ta a a aa hua eee Electrical System 0 2 0 0 0 00 EAE eee Control Panel Touchscreen Operation and Navigator wheel push button User Adjustable Parameters Operational capability 66 eee Output Compensation Functions Interface with PrimaSP2 and A200SP Ventilation Modes Standby Mode hh Volume Mode 52 need a a Bhd OR bees he aww db PressureMode llle els Spontaneous Mode PSV Pressure Supported Ventilation PEEP Positive End Expiratory Pressure On screen Menus tees Spirometty ociosa Display Waveforms rs Alarms susp sar ur 9E Ex e he kich a Reno A AO Oxygen Monitor System Operation The MOX 3 Oxygen Sensor Men s erica DISPIAY itae vane od morn Ane ete D 25 aan aah Aarts ss a ee x PRA be dos anal RR a a c Alarm MUG oo a inr DU E ee BOE ea aree GO ASS 0 S aba SPECIFICATION sese rs a gue dg Ve
58. s follows i If the Absorber Bag Vent control is moved from Vent to Bag the ventilator will change from Volume Mode or Pressure Mode into Spontaneous Mode ii Switching the absorber Bag Vent control from Bag to Vent The ventilator will reset from Spontaneous Mode to the previously set active mode iii If the ventilator is in any mode other than those detailed above operation of the absorber Bag Vent control will not affect the ventilator NOTE This function can be enabled disabled through the AV S on screen menus Service Sub menu see appendix DESCRIPTION 3 7 Ventilation Modes 3 7 1 Standby Mode Allows parameters to be set Some patient alarms are active High airway pressure at 80 cmH20 High Low O2 Negative pressure Incorrect Rate Ratio 20 DESCRIPTION 3 7 2 Volume Mode The ventilator delivers a mandatory set volume of gas at preset fixed breath intervals The Patient is making no respiratory effort 3 7 2 1 Fresh Gas Compensation Adjusts delivered volume up to 60 This delivered volume will consist of the volume delivered from the ventilator bellows plus the fresh gas flow from the anaesthetic machine fresh gas supply minus any compliance loss and minus any leak This gives a total actual inspired tidal volume An alarm is triggered if measured volume is 50 different than set volume User adjustable Altitude Co
59. sn jnejeq 1SN onewoiny ynejaq jnejeg Jesn ony S 0 onewony oneuioiny oneuioiny oneuioiny q 18S O19Z S 0cL 0Jez S 0cl 0J9Z S Oc S 0cL 0J8Z S Oc S OZ S Oc S Oc S Oc S Oc S Oc S Oc S Oc S 0 S Ocl S 0 0JOZ 0JOZ 0JeZ aun ain MWquoug MOT pajeadas sauo Buipuease uonug Wwinipayy Jaded ou sey Jo uamod ou seu JO pajoeuuoosip J ulid IN9J19 ous JO uornoeuuoosiq AZ LL mojaq peddoup seu eBeyoA Aieneg peBueuosip Aj e101 10 Burssitu JO pejoeuuoosip leneg pabreyo n s Auayeg J ejqejreAe asn sejnuiu OS gre amod suren uluu GZ apisino sBumes pajoauuoosip Josuaes peisneuxe eji Josuas en eA Jas ULY 1amo ZO Pases aNJEA 18S speeoxe ZO Pense enjeA Jas JO 0S speeoxe enjeA paene enjeA Jas Jo 0S speeoxe enjeA peunsee N Spuooes c UUM pajoaJep ureeJq ou epoui snoeuejuodg ul es euinjo Jo 0S Uy JeMo euinjoA pere nojeo peioeuuoosip Jejeujouds q Jes euinjoA JO 0S uey ssa 1A palnseay e OZHWO 0 speeoxe ainssaid uiejs s Buiureejg I A uinuuiuiu yea oj sje eunsseJd Wass Buiureeug ejqeisn pe OZHW 08 0 01 ywl Jos seuoeoi einssajg eseud Ayoyesidsu 1xeu eui jo ejs y Aq OZHWO OE mo q 0 uinjaJ 0j S rej eunsseJd Wayshs Bulule ig 9n3 196 18 pajenoeo spasoxy 1949 196 18 y9eaJ o S Ie 4 isd isd Ge ex Sez uey sse A Z 0L uey sse si abejjon leyeq ay pue Keneq uo s Jo e n
60. ssure Relief valve Set to 100 cmH20 Exhaust Port to AGSS Bellows drive gas outlet to bellows assembly DESCRIPTION 3 4 Electrical System Mains Supply The mains supply inlet is designed for connection to any mains voltage from 100 to 240 VAC and a frequency of 50 to 60 Hz without any adjustment The connector is a standard IEC type Back up Battery In the event of mains electrical failure the back up battery cuts in automatically A fully charged battery will power the ventilator for approximately 30 minutes See Appendix for battery care procedures DESCRIPTION A 3 5 3 5 1 3 5 1 1 C SET BPM 6 PEEP cmH 70 5 Insp Time Sec 2 Touchscreen control Control Panel Touchscreen and Navigator Wheel Push Button 1 Control Panel On Off control Switch On Short internal test sequence Switch Off 5 second power down sequence with audible tones Status indicators for electrical power mains battery supply Yellow indicator illuminated whenever power is applied to the unit and internal battery is being charged Green indicator illuminates when the unit is switched On Menu switch The menu function provides access to user and service pages Alarm mute switch 30 or 120 second Alarm silence depending on alarm status Note also that some alarms are not mutable see section 3 11 Gas Mixture Freeze Waveform P max mH20 24 C LIMIT
61. t The discharged gas may contaminate the environment and should therefore be extracted using a gas scavenging system The bellows can only support approximately 1 kPa 10 cmH20 differential positive pressure above which it may be dislodged from the mounting ring resulting in dangerous malfunction of the ventilator Do not connect a positive end expiratory pressure PEEP valve or other restrictive device to the exhaust port on the bellows base This would increase the pressure inside the bellows and the bellows could detach from the base causing serious malfunction Breathing System The breathing system which conveys gases from the anaesthetic machine to the patient and disposes of expired gases must conform to the requirements of ISO 8835 2 Because breathing systems require frequent cleaning and disinfection they are not a permanent part of the anaesthetic ventilator and therefore cannot be directly under the control of the anaesthetic ventilator manufacturer However we strongly recommend that only breathing systems which have been approved and authorised by the manufacturer for use with AV S should be employed Do not use conductive breathing system hoses When mechanical ventilation is employed the patient breathing system must be connected directly to a pressure relief valve to prevent the possibility of barotrauma Do not connect a spirometer to the exhaust port on the bellows base The device wil
62. t responsibility for any malfunction which may result from misuse of any kind or non compliance with other requirements detailed in this manual Worn broken distorted contaminated or missing components must be replaced immediately Should such a repair become necessary it is recommended that a request for service advice be made to Paragon Service This device and any of its constituent parts must be repaired only in accordance with written instructions issued by the manufacturer and must not be altered or modified in any way without the written approval of the manufacturer The user of this equipment shall have the sole responsibility for any malfunction which results from improper use maintenance repair damage or alteration by anyone other than the manufacturer USA and Canadian Federal Law restricts the sale and use of this device to or on the order of a licensed practitioner Statements in this manual preceded by the following words are of special significance WARNING means there is a possibility of injury to the user or others CAUTION means there is a possibility of damage to the apparatus or other property NOTE indicates points of particular interest for more efficient and convenient operation Always take particular notice of the warnings cautions and notes provided throughout this manual 1 WARNINGS AND CAUTIONS The following WARNINGS and CAUTIONS must be read and understood before using
63. t rate e g 10 bpm 3 Select 1 E ratio of 1 2 The point X on the graph lies beneath the 1 2 ratio curve and is therefore within the ventilator s capability 17 DESCRIPTION 3 5 4 Output Compensation Functions WARNING The AV S automatically compensates for fresh gas spirometry On fresh gas mixture spirometry and oxygen monitor On and altitude However the actual tidal volume delivered to the patient may be different to the ventilation parameters set by the user due to A an extreme compliance condition B a substantial system leak C patient circuit pressure effects or D extreme fresh gas flows In addition high fresh gas flows will lead to an increased Vt being delivered to the patient The patient must be monitored independently from the ventilator It is the responsibility of the user to monitor the patient for adequate ventilation Fresh Gas Compensation Adjusts delivered volume up to 60 Alarms if measured volume is 5096 different than set volume User adjustable NOTE Fresh gas compensation is disabled if a The spirometry system is turned OFF through the menu system or b The spirometry system is not functioning correctly Fresh Gas Mixture Compensation models with Spirometry The spirometry system compensates for fresh gas mixture the user must access the menu system and select the gas mixture that will be used for each clinical procedure NOTE Fresh gas mixture c
64. ted on an adjustable arm with the control unit mounted at the rear or side of the anaesthetic machine Optional mounting To fit the ventilator control unit permanently on a mounting bracket 1 Align the four mounting feet over the mating holes in the bracket 2 Use the four M4 screws supplied with the mounting bracket kit inserted through the bracket and rubber feet and screwed into the threaded inserts in the base of the ventilator Only use the screws supplied with the kit Pole mount type mounting brackets and side frame brackets are available from the manufacturer Bellows unit The bellows unit is built into the A200SP absorber 5 1 2 Electrical Power Connection Before connecting the ventilator to the mains supply check that the power supply is within the correct rating as stated on the label on the rear of the control unit WARNING Excessive electronic noise caused by other poorly regulated devices such as electrocautery may adversely interfere with the proper functioning of the ventilator To avoid this problem do not connect the ventilator power cord into the same electrical wall outlet or strip into which an electrocautery unit is connected 37 5 1 3 Ventilator Gas Supply 1 Verify the drive gas specified for the ventilator oxygen or air Always use the correct drive gas 2 Connect the drive gas inlet port on the rear of the control unit to a dry oil free supply Supply pressure ran
65. thetic machine Drive Gas Supply Flow sensor expiratory Flow sensor inspiratory Connectors sensor pressure monitor Expiratory Valve Absorber Inspiratory Valve Absorber Inlet from Ventilator Bellows Connector Reservoir Bag Inlet Absorber Fresh Gas Supply Drive Gas Inlet Ventilator Drive gas Outlet ventilator control unit to bellows Outlet Exhaust Valve Inlet Bellows Drive Gas Outlet to breathing system Input socket Oxygen monitor sensor Input socket Prima SP interface SP on off switch Input socket i A200SP Absorber Bag Vent control position ii Spirometer sensor signal Interface connections on Prima SP2 and A200SP APL Valve Outlet from APL Valve to AGSS Oxygen sensor Remote mounted display screen Cable control unit to screen 39 PRE OPERATION PROCEDURES Control Unit Rear Panel Gas Connections 1 Ventilator drive gas inlet connect to anaesthetic machine auxiliary gas outlet 2 Bellows Drive Gas Output connect to bellows on Prima SP2 with A200SP absorber connect to absorber see section 5 1 5 3 Outlet Exhaust Valve Electrical Connection 4 Electrical mains input and fuse unit 40 Interface and Parameter inputs 5 oo A200SP Absorber Bag Vent switch interface Spirometer connector Prima SP2 Interface connector Pressure Monitor Port Input socket Oxygen monitor sensor Data and Printer Ports 9 Data Output 10 Output t
66. thing system bacterial filter in the expiratory limb of the breathing circuit to protect the oxygen sensor see section 5 CAUTION Replacement Disposal always follow the instructions supplied with the filter and always replace at the recommended interval 3 12 2 The MOX 3 Oxygen Sensor The MOX 3 oxygen sensor offers quick response linear output over the entire 0 10096 oxygen range and long service life The MOX 3 is a self powered galvanic cell that generates a current proportional to oxygen concentration The cell has a highly stable output over its operating life Significant output loss is only shown at the very end of its life Typical sensor drift rates are less than 196 per month when the sensor is exposed to gas in typical applications Sensor life approximately 1500000 O2 percent hours at 20 C minimum one year in most normal applications Sensor lifetime is governed by the mass of lead available to react with the oxygen and its rate of consumption High oxygen partial pressure and high temperature will increase the sensor output current thus shortening the operation life At the point where all lead has been consumed the output will fall very quickly to zero over a period of two to three weeks 29 O2 Sensor Location Prima SP with A200SP Absorber DESCRIPTION 3 12 3 O2 Monitor sub menu ON OFF Turn the navigator wheel to switch between ON and OFF Press to confirm Scroll to
67. tioning correctly 9 Fresh gas mixture compensation is disabled if a The spirometry system is turned OFF through the menu system or b The spirometry system is not functioning correctly c The Oe monitor is switched OFF 10 Circuit compliance is not activated until Fresh Gas Compensation is switched OFF NOTES 1 The term cycle is used to designate the transition to the exhalation phase 2 The term trigger is used to indicate the transition to the inhalation phase WARNINGS AND CAUTIONS Oxygen Monitor Oxygen Monitor WARNINGS 1 We recommend calibration of the oxygen monitor every time the system s turned on as a safety precaution Do not attempt to open the fuel cell The sensor contains small quantities of a electrolyte classified as a harmful irritant which is potentially hazardous and b lead Used or defective cells must be disposed of according to hospital local state and federal regulations ALWAYS check the integrity of the sensor assembly before use Once exhausted the sensor must be disposed of according to hospital local state and federal regulations The sensor measures oxygen partial pressure and its output will rise and fall due to pressure change An increase in pressure of 10 at the sensor inlet will produce a 10 increase in sensor output CAUTIONS 1 Only use low temperature ethylene oxide sterilisation for the oxygen sensor The se
68. to customer s requirement 1 DISS Connector The gas source is connected to the DRIVE GAS SUPPLY fitting on the rear of the ventilator control unit The gas supply should be capable of a flow rate of 80 L min while maintaining a minimum pressure in excess of 310 kPa 45 psi 2 Filter The drive gas is filtered with a 40 micron Input Gas Filter which protects the pneumatic components from incoming particulate matter 3 The Low Supply Pressure Detector The pressure switch is set at a predetermined level to detect a loss or reduction of the input gas source pressure When the pressure falls below 235 kPa 35 psi 1 psi the LOW SUPPLY PRESSURE indicator will be displayed and the high priority audible alarm will activate 4 Input Pressure Regulator Regulates the input drive gas to 260 kPa 21 kPa 38 psi 3 psi 5 Cut off Valve The valve isolates the the gas supply a when the ventilator is switched off b when a fault condition occurs 6 Airway Pressure Sensor Connected to expiratory limb of breathing circuit 14 B 10 11 12 13 C 14 15 16 17 18 Pneumatic Control Manifold Block Inspiratory Proportional Valve Flow Sensor Drive Gas pressure Sensor Low Pressure Regulator Expiratory Proportional Valve PEEP pressure sensor Restrictor The restrictor allows a flow of up to 2 L min 2 L min bleeding Exhaust Manifold Block Check Valve Diaphragm Valve Pre
69. uSA ane l9yeg 10 eunjrej jeuleju 1966111 pojeedai sauo Buipueose Kjuoug YbIH MO Unipe MO Unipe MO Unipe YBIH MoT uBiH yBIH yBIH UBIH YBIH YBIH YBIH YBIH YBIH yBIH YBIH YBIH yBIH yBIH uBiH yBIH Aoud uomneoiinuepi llolId e qejreAe jou Jajuld dS001V une ejqeo Jaquosqy Asayyeg mo 14 Jamogy laneg 2184 sure OljeH JO ajey joaJJo9u yne Josuas ZO jndino mo josues ZO uoneJue2uo ZO 01 uonenueouo ZO UBIH euinjoA anun YBIH un oA epi YBIH eeoudy eulnjoA anu MO euinjoA ep AO 9 nssalg Aemiiy oAneDoN einssaeJg eMuly MO eanssaJg Key yBiH ejnsseJg emy snonunuo uBiH olyewoyny einsseJg sec eAug swojeg UYBIH eJnsseJg sec BAU SMO 9SG MOT ejnssaJg Ajddng sec eAug moq Ied 01 31noqy 19wog oAje1edou Jo e nnuaA wey 28 DESCRIPTION O2 Monitor 3 12 Oxygen Monitor The oxygen monitor continuously measures and indicates the concentration of oxygen in the breathing system and triggers an alarm when the concentration varies from the set levels 3 12 1 System Description The Oxygen Monitor uses a fast responding oxygen specific self powered sensor that achieves 90 of final value in less than 10 seconds An external probe 1 is supplied with a 2 m 6 ft extendable cable The system has user adjustable high level and low level alarms with visual and audible indication of alarm conditions Bacterial Filter Use a brea
70. ufacturer Paediatric Bellows Assembly 1 45 Remove the adult bellows housing 1 twist carefully counterclockwise until the bayonet tabs become free then lift up from the base 2 Remove the bellows 3 Fit the paediatric adaptor 5 press the adaptor into the ventilator bellows assembly base 2 Fit the paediatric bellows 6 to the adaptor Check for correct assembly as illustrated 4 Fit the paediatric bellows housing 7 to the base by pushing down then twisting clockwise until the bayonet tabs completely engage Function test the ventilator section 5 3 1 PRE OPERATION PROCEDURES 5 2 Pre use Checklist 5 2 1 Daily Checklist The following tests must be carried out at the beginning of every working day Alarm System WARNING The operation of each alarm function should be verified daily If the audible alarm or the visual display for any alarm function fails to activate during any alarm condition or fails to reset after the alarm has been cleared refer the unit to an authorised service technician Back up Battery WARNING If the internal battery is fully discharged the ventilator will not function Recharge the battery before the ventilator is used clinically Charging the battery for 14 hours from a discharged state will allow a minimum of 30 minutes of continuous operation Connect the ventilator to a mains power supply The mains power indicator will illuminate to
71. ve and clean as required Test the Mains Failure Alarm and the Low Supply Pressure Alarm Every 6 months Inspection and Function Check Remove patient block assembly and clean Check condition of bellows Every 12 months Repeat six month procedure plus Replace O seals and drive gas inlet filter Replace exhaust diaphragm valve Preventive maintenance kit available Every 2 years Repeat 12 month service plus Replace 12v battery Every 4 years Repeat 2 year service plus Replace PCB battery Replace bellows diaphragm valve Details of these service operations are given in the Service Manual Always ensure that a record is kept of any service or repair work 52 6 2 Cleaning 6 2 1 Outside surfaces and bellows housing CAUTION Care must be taken not to allow liquids to run into the control unit serious damage may result Check that the unit is disconnected from the electrical supply before cleaning Do not use cleaning solutions containing alcohol the bellows housing may be damaged To clean the outside surfaces of the ventilator units and cables use a damp cloth screen see below If necessary use a warm mild detergent solution to remove resistant grime Make sure that all detergent residues are fully removed after cleaning Never use any harsh abrasive cleaning agent The transparent acrylic bellows housing and in general the surfaces of the control unit are not scratch resistant
72. vered volume will consist of the volume delivered from the ventilator bellows plus the fresh gas flow from the anaesthetic machine fresh gas supply minus any compliance loss and minus any leak This gives a total actual inspired tidal volume A similar measurement method is used for the exhaled volume During the exhalation period the measured exhaled volume is subtracted from the inspired volume and at the end of exhalation A negative more gas coming out volume indicates that fresh gas has increased the delivered volume A positive volume less gas coming out indicates a leak in the circuit The ventilator control system will then adjust the next delivered tidal volume up to a maximum of 100 ml This will bring the delivered volume to exactly as set If the variation between set and delivered is greater than the maximum rate of change allowed the adjustment will occur gradually over several breaths The displayed volume is the average of the inspiratory and expiratory volumes If this value is less or more than 5096 of set volume a low or high volume alarm is given Breathing System Gas Composition Gas flow measurements are affected by the breathing system gas composition To compensate for these effects the ventilator has a a gas composition setting whereby the user is able to select the gasses being delivered i e oxygen air oxygen nitrous oxide etc b an oxygen monitor Thus the ventilator knows the overa

SC430 User Manual-AV-S

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