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Penlon AVS - Ardus Medical

1. 42 Ventilator Gas Supply iw ee 43 Breathing System Schematic te 43 Bellows Drive GaS as fb Made RR Rel earn Rion Ree Oe 47 Anesthetic Gas Scavenging System 47 Remote Screen zik dac AR u Gak sae LX HERE RU deans 48 Printer inks ke aed he debe C8 D SES hdd jan diee Nel ial d e 48 Breathing Systemi seac peres ete q EGO NR ku RR E ed 48 Spirometer Connections 49 Pressure Monitor Connections 51 Leak Test Compliance value Compensation 52 Bellows Assembly eur RT ESRPEPIG a APPUYER oe 54 Pre use Checklists ee 55 Daily Checklist srera RP gu s eed CE x RP ERE ders 55 Alarm System cridesto b xx ds s es a AURA OR age EE arr dat 55 Ventilator Internal Test llli les 55 Function Test ica doe e pam dee ele RR Y 56 Weekly Checklist scotia eke eee edd eee ede aden ee Chaka 57 Oxygen Monitor Set up 58 Installation usu usss ede CED ae dene dead eee EUR AA 58 Calibration samsa a aha poe RR EE eae eee wks wee A Ee ee 58 Sensor Low Indication 60 Setting the High and Low O2Alarms 60 MAINTENANCE Service Schedule eee 61 Cleaning 2222 2e a eue AES NEP A u Ca aU d eg 6
2. ii CONTENTS USER RESPONSIBILITY ene 1 WARNINGS AND CAUTIONS eese 2 PURPOSE uuu coe ea edad oinn woud ka PR ada ae aaa aa be RATER 3 DESCRIPTION 3 1 General 6 5 424444 doa cde e de bd dg ARD ewe W huuu 3 2 Ventilation Cycle es 3 3 Pneumatic System lllsslll ees 3 944 System Operation u u y ur ER EXER REENE ETARA GER 3 4 Electrical System i 3 ddd EE p pawasqa Eug w e kia exu 3 5 Control Panel llle 3 5 1 Touchscreen Operation and Navigator wheel push button 3 5 2 User Adjustable Parameters iliis eee 3 53 Operational capability iis kx 3 RR bada PEE RU ERREESERS 3 5 4 Output Compensation Functions 3 6 Interface with Integra AV S and A200SP 3 7 Ventilation Modes llle 3 Standby Mode sce ERE E EG nima ERU dd Ra Ra RE Rea 2 2 Volume Mode icd ER EERXGEAEWEEGCG ERE XX NES 3 7 3 PressureMode ssl 3 7 4 Spontaneous Mode ssl 3 7 5 Advanced Spontaneous Breathing Modes 3 7 5 1 SIMV Synchronised Intermittent Mandatory Ventilation m 3 7 5 2 SMMV Synchronised Mandatory Minute Ventilation 3 7 5 3 PSV Pressure Supported Ventilation lessen 3 7 5 4 PEEP Positive End Expiratory Pressur
3. APPENDIX 1 Care of Back up Battery CAUTION Damage may occur if the battery is allowed to remain in a discharged state A Battery installed in ventilator The battery 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 1209F Storage Recharge temperature period 38 to 50 C 100 to 1229F 1 month 21to 389C 70 to 1009F 3 months 7 to 21 C 45 to 709F 6 months 0 to 79C 32 to 45 F 9 months 5 to 09C 23 to 329F 12 months Recharge duration a charging cycle of at least 12 hours to ensure that the battery is kept at full capacity 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
4. SIMV No breathing effort by Patient A Cycle Time set from BPM B Trigger Window C Flat Pressure Trace no breathing effort D Mandatory breath at the end of the Trigger Window at the set Vt If the patient makes no effort to breathe during a cycle a mandatory breath at the end of the trigger window will still be delivered at the preset volume and rate DESCRIPTION 3 7 5 2 SMMV Synchronised Mandatory Minute Ventilation SMMV provides a set level of minute volume ventilation SMMV allows spontaneous breaths combined with a synchronised mandatory breath to achieve the set minute volume SMMV must be pre selected in Standby Mode Select Standby Select Menu Select Special Modes Select Support Mode Select SMMV Escape Menu SMMV will now be displayed on the main screen when Spontaneous mode is selected or triggered NOTE J The trigger window is pre set to 60 of the BPM cycle time 2 The trigger is flow activated 3 If the Spirometry is disabled then SMMV is not available 4 If the pressure limit and alarm are activated the inspiratory phase is terminated Activate SMMV during Ventilation NOTE SMMV will not function unless already pre selected in Standby Mode 1 Select Special Mode on the display If the absorber Bag Vent switch is not detected a message will appear SET ABSORBER TO VENT Press the navigator wheel push button to confirm 2 Move the absorber Bag ven
5. Serial mode pick list NONE PHILIPS SPACELABS Clock ESCAPE FROM MENU YEAR 2005 MONTH 3 DATE 16 DOW 3 HOUR 9 MINUTE 57 UPDATE CLOCK DAYLIGHT SAVING off Upgrade ESCAPE FROM MENU I O HARDWARE 2 I O FIRMWARE v0 47 Build 68 Clock pick list 2005 2099 1 12 1 31 1 7 1 Monday 0 23 0 59 off on 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 integer integer integer integer integer integer integer toggle option NOTE Service PIN Engineer Menu Sub menus are not accessible by users 70 APPENDIX APPENDIX 3 AV S Ventilator Spirometry System Ventilator Spirometry Measurement The AV S ventilator drive gas system and spirometry system uses a total of three mass flow gas sensors The sensors monitor and then independently measure the gas flows within the ventilator and breathing system This ensures that correct volumes are delivered to the patient The sensors 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
6. the ventilator will switch from Pressure Mode or Volume Mode to Spontaneous Mode see 3 6 2 Absorber Interface Functions No mechanical ventilation No Inspiratory Pause function Patient Monitoring Bag mode and Ventilator mode Airway pressures FiO2 Tidal volume Rate E ratio Supply pressures Advanced Ventilation Modes Patient support modes are selectable from this mode see below and section 3 7 5 3 7 4 3 Patient Support Modes The following support modes are selectable from the Special Modes menu and must be pre selected from the main menu whilst in Standby SIMV Synchronised Intermittent Mandatory Ventilation SMMV Synchronised Mandatory Minute Ventilation PSV Pressure Supported Ventilation CAUTION The required patient support mode must be pre selected in Standby Mode select from main menu before it can be activated during the ventilation of a patient Please refer to sections 3 7 5 1 3 7 5 2 3 7 5 3 Note that if the system fails to detect an absorber bag vent switch a confirm message will be displayed 25 DESCRIPTION 3 7 5 Advanced Spontaneous Breathing Modes 3 7 5 1 SIMV Synchronised Intermittent Mandatory Ventilation SIMV provides a minimum level of tidal volume SIMV allows spontaneous breaths and a set mandatory breath synchronised with the start of a patient breath SIMV must be pre selected in Standby Mode Select Standby Select Menu Select Special M
7. 3 Anew Volume value can be set if required WARNING Set appropriate values for the clinical procedure in progress Take note of all on screen symbols and display messages 4 Press to confirm change of mode and new setting NOTE Pressure limit will default to the previous Pressure Target value 5 cmH20 5 At confirmation the ventilator will switch to Volume Mode NOTE Volume Mode will commence at the beginning of an exhalation 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 3 7 2 4 Volume Mode Operating Functions Inspiratory Pause function This function creates a plateau that equates to 25 of the inspiratory time Select Inspiratory Pause Press the Menu switch Select Special Modes Select Insp pause on off Exit menus The symbol for Inspiratory Pause will appear on the display ii Note that Inspiratory Pause function is cancelled when Standby is selected 22 Menu Switch Turn the wheel to scroll through the menus Press to enter sub menu EXIT MENUS O2 MONITOR amp SPIROMETRY FRESH GAS COMPENSATION ON SPECIAL MODES WAVEFORM ALARM SETTINGS GAS MIXTURE 02 AIR USER SETTINGS SERVICE MENU DESCRIPTION Sigh function When the ventilator is in Volume Cycle mode the Sigh option is available When selected this option provides ext
8. 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 ventilator 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 60 High Alarm Set Value FEE 21 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 On Off Switch Alarm Mute Menu Switch Low Alarm Set Value Navigator Wheel and Press Button 6 MAINTENANCE WARNING 1 User maintenance is restricted to cleaning the outside surfaces of the device as deta
9. Do not dispose of in landfill refer to an approved recycling facility Follow your hospital local state and federal regulations Note Removal replacement of battery must only be undertaken by a trained technician 66 APPENDIX APPENDIX 2 On screen Menus NOTE 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 cmH2O Ptarget 10 cmH20 Pediatric default settings VT 150 ml RATE 15 BPM IE RATIO 1 2 Plimit 38 cmH20 Ptarget 10 cmH20 67 Menu Structure Main Menu O2 Monitor amp Spirometry ESCAPE FROM MENU O2 MONITOR on CALIBRATION 100 HIGH ALARM SET 105 LOW ALARM SET 18 SPIROMETER on SPIRO CALIBRATION 0 L min off on Toggle option 21 100 Toggle option 19 105 Integer 18 99 Integer off on Toggle option 0 L min 10 L min Toggle option EXIT MENUS O2 MONITOR amp SPIROMETRY LEAK TEST FRESH GAS COMPENSATION ON SPECIAL MODES WAVEFORM ALARM SETTINGS GAS MIXTURE O2 AIR USER SETTINGS SERVICE MENU Leak Test ESCAPE FROM MENU lt START STO
10. Hz 0 6 A max 200 240 VAC 50 60 Hz 0 3 A max automatic ranging Two fuses Type T 2AH 2A 250 V rating 20 mm anti surge ceramic Standard battery 12 V 1 2 Ah sealed lead acid battery Fully charged battery provides 30 minutes nominal backup High power battery option 12 V 2 Ah sealed lead acid battery Fully charged battery provides one hour nominal backup 3 A mini blade type Oxygen or Air dry and oil free at 45 to 100 psi 310 to 689 kPa 30 or 120 seconds see 3 11 Flow referenced no breath detected within 15 seconds Less than 235 kPa 35 psi Above 30 cmH20 at start of cycle Volume Mode alarms after 10 seconds Standby Mode alarms after 30 seconds 4 14 cmH20 PEEP referenced Fully charged standard battery provides 30 mins nominal backup Fully charged high power battery option provides one hour nominal backup 5 minutes Use Internal or Battery Failure Exhaust valve outlet blocked 37 SPECIFICATION Alarms User Adjustable Low Tidal Volume High Tidal Volume Low Minute Volume High Minute Volume Low and High O2 Concentration High Airway Pressure Measured value is below 50 of volume set Range 0 1600 ml Measured value exceeds 150 of volume set Range 20 1600 ml Calculated value is 5096 below volume set Range 0 10L Calculated value exceeds 15096 of volume set Range 0 30L 1896 10596 10 80 cmH20 adjustable 4 5 Functional Tidal Volume Adult bellows 20 t
11. Pressure Mode Pressure Mode selected from Standby Mode 1 Select by touching the screen tab PRESS CONTROL Pressure Mode selected from Volume Mode NEN 1 Select by touching the screen tab PRESS CONTROL The ventilator continues to ventilate in Volume Mode Eu 2 The target pressure button flashes the display shows CONTROL the previous setting of target pressure or default setting 3 The user can set a new Target Pressure if required WARNING Set appropriate values for the clinical procedure in progress Take note of all on screen symbols and display messages 4 Press to confirm change of mode and new target pressure 5 At confirmation of the new mode the ventilator will switch to Pressure Mode NOTE Pressure Mode will commence at the beginning of an exhalation phase 3 7 3 3 Pressure Mode Operating Functions Pressure mode defaults to a target pressure of 10 cmH20 at switch on A high Inspiratory Flow is used to achieve and maintain the target pressure The exhaust valve operates to prevent excess pressure 24 DESCRIPTION 3 7 4 Spontaneous Mode 3 7 4 1 Parameters The ventilator monitors the following patient parameters Rate E ratio Pressure Tidal volume In spontaneous mode the waveform displays are active and inspiratory oxygen levels are measured 3 7 4 2 Spontaneous Mode Operating Functions Selection during Ventilation Move the absorber Bag vent switch to Bag
12. RT MODE psv simv smmv A SIGH ENABLE off SIGH TO BREATH RATIO 1 50 INSP PAUSE off Apnoea Alarm Mute Spontaneous mode only NOTE The occurrence of another alarm event will override this feature In spontaneous mode the mute button acts both to silence an existing apnoea alarm and inhibit new apnoea alarms for a given period provided that no other alarm events are present This time period is selectable choose from 15 30 60 120 or 180 seconds through the alarm settings menu or accessed by touching the alarm area of the screen To adjust the default setting use the SITE DEFAULT menu option Touchscreen Access to Mode Configuration Options Touch the screen in the area containing the green icons to access mode configuration options including INSP PAUSE SIGH and APNOEA ALARM mute inhibit Waveform Pause and Print Waveform pause and print icons are located to the left hand side of the waveform displays e 8 ci Ensure that a compatible printer is connected and switched On see section 5 1 8 To print the waveform information press the pause icon The print icon will be displayed Press the icon to print Press the pause icon to unfreeze the waveform Baonsda d n m Waveform Freeze Loop The FREEZE LOOP icon is located at the left hand side of the top waveform Leak Test a Select LEAK TEST through the Menu in Standby Mode b With the bag vent switch in V
13. are OFF 4 Apply 10096 oxygen only at 5 L min from the anesthetic 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 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 O2 AT 100 Press the button 5 to confirm O2 Monitor amp Spiro NOTE The message ESCAPE FROM MENU OXYGEN SENSOR LOW OUTPUT O2 MONITOR on will appear on screen if the user attempts to CALIBRATION 100 calibrate at 21 in 100 oxygen HIGH ALARM SET 105 10 Scroll to ESCAPE FROM MENUS and press EC ALARM SET TR the button 6 to exit T SPIROMETER on SPIRO CALIBRATION 0 L min 11 Turn off the flow of oxygen 12 Refit the absorbent canister 1 59 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
14. 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 Oxygen Monitor Alarms HIGH O2 ALARM The high O2 alarm is triggered when the oxygen concentration is 1 above the set value a The High O2 Alarm visual indicator will illuminate b A high 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 35 DESCRIPTION O2 Monitor LOW O2 ALARM The low alarm is triggered when the oxygen concentration is 1 below the set value a The Low O2 Alarm visual indicator will illuminate b A high 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 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 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 O2 SENSOR LOW This alarm indicates the sensor has approached the end of its life The legend O2 SENSOR LOW will be displa
15. c SMMV d SIGH ENABLE SIGH TO BREATH RATIO e INSP PAUSE INSP PAUSE WARNING Modes a b and c are only available when Spirometry is enabled j SUPPORT MODE psv simv smmv H SIGH ENABLE off SIGH TO BREATH RATIO 1 50 INSP PAUSE off Al NSP PAUSE 0 AS MXTURE O2 AIR 4 2 4 3 4 4 4 5 Standby Mode a Standby mode at ventilator start up The last used Volume mode settings will be displayed b Standby mode selected while the ventilator is in use The screen will display the previous ventilation mode highlighted in yellow within the relevant box The last used parameters will also be displayed Spontaneous Mode a Spontaneous mode at ventilator start up Default values will be displayed in white on a black background if the ventilator has just been powered ON b Spontaneous mode selected while the ventilator is in use The last used ventilation mode underlined will be displayed with the last used set values in white on a black background Sigh Sigh is settable from 1 n where n has a range of 10 to 100 The Sigh menu can also be accessed by touching the icon area of the screen NOTE 1 10 is one sigh to ten normal breaths Inspiratory Pause Inspiratory pause can be varied in the menu from 0 60 The inspiratory pause menu can also be accessed by touching the icon area of the screen WARNING This can affect the maximum Tidal Volume 1
16. monitor Thus the ventilator knows the overall oxygen concentration and the majority of the remaining gas composition 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 used 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 APPENDIX Anesthetic Agent Effects The addition of anesthetic agent is known also to increase the spirometry readings by up to approximately 2 depending on the agent and its concentration 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 volumes in the breathing gas are not detectable in normal breathing system dynamics Additional Features Additional spirometry features available for s
17. results in synchronised pressure support PSV must be pre selected in Standby mode Select Standby Mode Select Menu Select Special Modes Select Support Mode Select PSV Escape Menu PSV will be displayed on the main screen when Spontaneous mode is selected or triggered Activate PSV during Ventilation NOTE PSV will not function unless already pre selected in Standby Mode 1 Select Special Mode on the display If the absorber Bag Vent switch is not detected a message will appear SET ABSORBER TO VENT Press the navigator wheel push button to confirm 2 Move the absorber Bag vent switch to Ventilator 3 Check that PSV is functioning correctly 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 system is disabled then PSV is not available 4 If the pressure limit and alarm are activated the inspiratory phase is terminated PSV Default Settings The ventilator will default to pre set values for Support Pressure Inspiratory Time and Trigger Level after selecting PSV Note 1 Support Pressure can be adjusted before PSV is confirmed 2 The trigger setting is adjustable between 0 7 and 4 0 L min PSV Pressure Supported Ventilation A Set Inspiratory Time B Pressure Support Level C Spontaneous Breath results in a synchronised pressure supported breath PSV is used to support spontan
18. 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 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 WARNINGS AND CAUTIONS 25 26 27 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 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 28 User maintenance is restricted to cleaning the outside surfaces of the ventilator see section 6 Other procedures detailed in this manual must be c
19. volume indicated on the scale printed on the bellows housing should be approximately 600 ml If the delivered tidal volume is less than 500 ml or greater than 700 ml refer the ventilator to an engineer trained by the manufacturer 8 Set a basal flow only on the anesthetic 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 9 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 10 Open the patient Y piece to ambient pressure At the second cycle the LOW AIRWAY PRESSURE alarm should be activated 11 Select STANDBY mode Before using the ventilator clinically check that all connections are correct and verify that there are no leaks 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 56 PRE OPERATION PROCEDURES 5 2 2 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 FAIL
20. 0 5 L 1 0 L 2 0 L X axis a The scale adjusts as Rate is changed 0 to 15 sec 5 sec 3 sec b In Vol v Pres mode the scale adjusts as Plimit is changed 20 to 40 60 80 cmH20O 31 DESCRIPTION Alarms 3 11 NOTE User Adjustable Alarms use the menu system to set the required limits press the menu switch on the front panel see 3 8 and select ALARM SETTINGS pajeadas euo ajBulg onewoiny onewoiny onewoiny onewoiny onewoiny jnejeq 4esf jnejeq 4esf ynejeg 1esn ynejeg iesn oneuloiny jnejed Jes ynejeg 1esf onewoiny onewoiny jnejeq SN ony opewony opewony opewony opewony Sneuio ny Sneuuio ny Aq 39S OJOZ S 0 L OJez S 0 L OJoZ S 0 L S 0 L OJez S 0 L S 0 L S 0 L S 0 L S 0 L S 0 L S 0 L S 0 L S 0 L S 0 s oZ sog sog OJoZ OJoz OJoz OJoZ eun en AJUOUd MOT pejeedai seuoj Buipueose eaJjj Kjuoug winipeyy Jaded ou sey Jo jewod ou sey 10 pejoeuuoosip Jejutd N3119 luous JO uonoeuuoosiq Z LL oJeq peddoup seu beyon fueneg peBueuosip Ajje o 40 Buissiu Jo pejoeuuoosip Aueyeg Auepmeq Jamod ufiu ULM suitu 99 esn suluu QE s n Kuepneq peBueuo ApnJ sje Jamod sule uluu 1 GZ pis no sBumes pejoeuuoosip Josuegs pejsneuxe i Josues ane Jes ULY Jewo ZO peunseelN enjeA jes speeoxe ZO peunsee y NJeA 18s JO 9508 speeoxe enjeA p e n5jeO ANIEA JOS JO 0S speeox
21. 00 cmH20 17 Exhaust Port to AGSS 18 Bellows drive gas outlet to bellows assembly 13 DESCRIPTION 3 4 Electrical System Mains Supply The mains supply inlet is designed for connection to the following mains voltage supplies 100 to 120 VAC 50 to 60 Hz 200 to 240 VAC 50 to 60 Hz Note that the ventilator adjusts automatically to the supply voltage range The connector is a standard IEC type Back up Battery In the event of mains electrical failure the back up battery cuts in automatically Standard battery A fully charged battery will power the ventilator for approximately 30 minutes High power battery option A fully charged battery will power the ventilator for approximately one hour See Appendix for battery care procedures 14 DESCRIPTION Gas Mixture O gt air PRESSURE CONTROL VOLUME CONTROL SPONT MODE PEEP LIMIT cmH50 cmH20 STANDBY 3 5 Control Panel 3 5 1 Touchscreen and Navigator Wheel Push Button 3 5 1 1 Control Panel 1 On Off control Switch On Short internal test sequence Switch Off Power down sequence with progress indicator 2 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 3 Menu switch The menu function provides access to user and service pages including alar
22. 1 MAINTENANCE 62 Cleaning 6 2 1 Outside surfaces CAUTION a Care must be taken not to allow liquids to run into the control unit serious damage may result b Check that the unit is disconnected from the electrical supply before cleaning c Do not use harsh abrasive cleaning agents To clean the outside surface of the ventilator use a damp cloth that has been immersed in a cleaning solution and thoroughly wrung out Use cleaning agents as recommended by your hospital infection control department Use a warm mild detergent solution to remove resistant grime To remove blood etc clean as above then use an antiseptic solution or anti microbial wipes Make sure that all cleaning agent residues are fully removed after cleaning Touchscreen Use a soft cloth only Never use any harsh abrasive cleaning agent 6 2 2 Bellows Assembly The bellows assembly is built into the A200SP absorber For further information please refer to the user instructions supplied with the A200SP 6 2 3 Spirometer Sensors The sensors are built into the A200SP absorber and cleaning and sterilization 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 6 2 4 Oxygen Monitor Sensor The sensor 1 is built into the A200SP absorber For further information please refer to the user instructions supplied with the A200SP WA
23. 2 Outside Surfaces nes 62 Bellows Assembly iss s hh 62 Spirometer Sensors ille llle 62 Oxygen Monitor Sensor wk sers 62 Patient Connector Block smene ee 63 Sterilization ee PR eR RE NER 64 Oxygen Monitor Sensor Replacement 65 APPENDIX 1 Back up Battery usuyasa sasa aaa kau radd teradi eRe Ou 66 2 Menu System coke erano w q C kaa 67 3 Ventilator Spirometry System _ lessen 71 4 Disposal afteruse 00000 es 73 5 Approved Accessories 73 iv USER RESPONSIBILITY This anesthesia 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 accept responsibility for any malfunction which may result from misuse of any kind or non compliance with othe
24. DES menu is In SPONT mode the SPECIAL MODES menu is In VOLUME Control the SPECIAL MODES menu is In PRESSURE SIMV SMMV or PSV modes ESCAPE FROM MENU SUPPORT MODE none 1 TRIGGER 1 0 L min 2 SIGH ENABLE off 9 SIGH TO BREATH RATIO 1 50 4 INSP PAUSE off 3 ESCAPE FROM MENU TRIGGER 1 0 L min 2 ESCAPE FROM MENU SIGH ENABLE off 3 SIGH TO BREATH RATIO 1 50 4 INSP PAUSE off 3 The SPECIAL MODES menu is unavailable Notes 1 2 3 4 Support mode depends on configuration options The SUPPORT MODE option will be missing from the SPECIAL MODE menu if a Options are not enabled b SPIROMETRY off is displayed The support mode sub menu can include none PSV SIMV SMMV The TRIGGER values are L min with SPIROMETRY enabled or cmH20 when SPIROMETRY disabled Spirometry enabled Spirometry disabled 0 7 L min 0 5 cmH20 0 8 L min 0 6 cmH20 0 9 L min 0 7 cmH20 1 0 L min 0 8 cmH20 1 5 L min 0 9 cmH20 2 0 L min 1 0 cmH20 2 5 L min 1 2 cmH20 3 0 L min 1 5 cmH20 3 5 L min 1 7 cmH20 4 0 L min 2 0 cmH20 The options here are on or off The options here are 1 50 2 50 3 50 4 50 69 SERVICE MENU Service ESCAPE FROM MENU LANGUAGE ENGLISH PRINT PATIENT DATA SERIAL MODE none CLOCK MENU UPGRADE MENU AMBIENT PRESSURE 988 mBar DISPLAY HISTORY SERVICE PIN 0 ENGINEER MENU Language pick list ENGLISH ITALIANO TURKCE POLSKI ESPANOL
25. ENT position this checks for a leak using an occluded breathing system The leak test procedure is given in section 5 1 12 in the user manual Modifications to Operational Envelope sections 4 5 and 4 6 in user manual Flow Range 2 70 Litres per min Volume Range 20 ml 1 6 Litres tidal 2 50 Litres per min minute vol Rate 4 100 bpm E Ratio 1 0 2 1 8 0 normal 1 2 0 1 8 0 effective in support modes Inspiratory Time 0 3 10 seconds normal 0 3 5 seconds effective in support modes ExpiratoryTime 0 3 10 seconds effective dependent on Inspiratory time Additional information on Sigh and Inspiratory Pause section 3 7 2 4 Inspiratory Pause Inspiratory Pause has a range of 0 to 60 of the inspiratory time Sigh This function must be enabled in the mode menu but is only operational in volume ventilation The sigh ratio is 1 to n 1 n with n giving a range of 10 100 breaths between sighs Menu Structure Main Menu O2 Monitor amp Spirometry ESCAPE FROM MENU O2 MONITOR on CALIBRATION 100 HIGH ALARM SET 105 LOW ALARM SET 18 SPIROMETER on SPIRO CALIBRATION 0 L min off on 21 100 19 105 18 99 off on 0 L min 10 L min Toggle option Toggle option Integer Integer Toggle option Toggle option EXIT MENUS O2 MONITOR amp SPIROMETRY LEAK TEST FRESH GAS COMPENSATION ON MODES WAVEFORM ALARM SETTIN
26. GS GAS MIXTURE 02 AIR SERVICE MENU Leak Test ESCAPE FROM MENU lt START STOP LEAK TEST gt LEAK STATUS unknown LEAK LEVEL 0 mL min BSYS COMP 7 0 mL cmH20 Fresh Gas Compensation ON OFF off on Toggle option Special Modes See next page 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 HIGH TIDAL VOLUME off VM MIN 3L VM MAX 9L VT MIN 300 mL VT MAX 900 mL APNOEA ALARM LIMIT 15 secs ALARM VOLUME 50 default user off on 0 0 7 4 0 1 7 5 10 1600 20 2400 0 3 3 5 50 10096 Toggle option Toggle option Integer Integer Integer Integer Integer Integer Gas mixture O2 Air O2 AIR O2 N20 Service See page 62 SPECIAL MODES MENU ESCAPE FROM MENU SUPPORT MODE SIMV SMMV PSV VOLUME TYPE Tidal SIGH ENABLE SIGH TO BREATH RATIO INSP PAUSE 0 APPLY SITE DEFAULT The SPECIAL MODES menu is context sensitive with the contents dependent on current mode In STANDBY the SPECIAL MODES menu is ESCAPE FROM MENU SUPPORT MODE SIMV SMMV PSV 1 VOLUME TYPE Tidal SIGH ENABLE 2 SIGH TO BREATH RATIO INSP PAUSE 0 APPLY SITE DEFAULT In SPONT mode and VOLUME mode and SIMV SMMV the SPECIAL MODES me
27. OPERATION PROCEDURES 5 1 13 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 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 4 Fit the bellows housing by pushing down then twisting clockwise until the bayonet tabs completely engage 5 Function test the ventilator section 5 3 1 w 5 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 Pediatric Bellows Assembly 1 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 2 Fit the pediatric adaptor 5 press the adaptor into the ventilator bellows assembly base 2 3 Fit the pediatric bellows 6 to the adaptor Check for correct assembly as illustrated 4 4 Fit the pediatric bellows housing 7 to the base by pushing down then twisting clockwise until the bayonet tabs completely engage 5 Function test the ventilator section 5 3 1 54 Note that the bellows assembly is built into the A200SP Absorbe
28. P LEAK TEST gt LEAK STATUS unknown LEAK LEVEL 0 mL min BSYS COMP 7 0 mL cmH20 Fresh Gas Compensation ON OFF off on Toggle option Special Modes See next page 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 HIGH TIDAL VOLUME off VM MIN 0 3 L VM MAX 0 9 L VT MIN 300 mL VT MAX 900 mL APNOEA ALARM LIMIT 0 3 cmH2O ALARM VOLUME 50 default user Toggle option off on Toggle option 0 0 7 4 Integer 0 1 7 5 Integer 10 1600 Integer 20 2400 Integer 0 3 3 5 Integer 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 USER5 CCT5 ADULT DEFAULT PEDIATRIC 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 Volume type tidal minute toggle Service See page 62 68 SPECIAL MODES MENU NOTE The SPECIAL MODES menu is context sensitive with the contents dependent on current mode In STANDBY the SPECIAL MO
29. PM Insp time Trigger Adult 3 6L 6 2 sec 1 L min Pediatric 2L 10 1 sec 1 L min PSV Support Pressure Trigger Adult 10 cmH2O 1 L min Pediatric 10 cmH2O 1 L min 4 7 Disinfection and Sterilization Patient Block assembly can be sterilized if necessary section 6 NOTE The bellows assembly oxygen monitor sensor and spirometer sensors are built into the A200SP Absorber for information please refer to the User Manual for A200SP 4 8 Bacterial Filter None always use a bacterial filter in the breathing system to protect the oxygen sensor see section 5 1 4 4 9 Fail Safe Mechanism Battery back up in case of mains electricity failure Gas shut off in the event of electronic failure 4 10 Reliability Not applicable 4 11 Waveform Tests Not applicable 4 12 Volume Tests Not applicable 4 13 Mobility and Mounting A Mobility B Mounting Secure mounting required Control unit and remote screen are mounted on anesthetic machine The bellows assembly is built into the A200SP Absorber 39 SPECIFICATION 4 14 Environmental Operating Temperature 15 to 309C 59 to 86 F Humidity 10 95 RH relative humidity non condensing Altitude Up to 2775 m 9000 feet Air Pressure 70 110 kPa Storage and Transport Temperature 5 to 40 C 23 to 1049F Note For battery care during storage refer to Appendix 1 Humidity 10 95 RH relative humidity non condensing Air Pressure 11 5 110 kPa Electro magnetic compatibili
30. RNING The sensor is not suitable for sterilization If contamination is suspected fit a new sensor see section 6 4 Dispose of the contaminated unit according to hospital local state and federal regulations 62 MAINTENANCE 6 2 5 Control Unit Patient Block Assembly These operations must be carried out by suitably trained technicians only 6 2 5 1 Inspection frequency and indications On a regular basis in line with hospital procedures for infection control and at least every six months the patient block 1 must be removed cleaned and sterilized 6 2 5 2 Disassembly 1 Detach the hoses from the outlets 2 Note the different diameters for correct refitment 2 Undo the securing knobs 3 3 Carefully detach the assembly 1 from the control unit Note that resistance will be felt until the metal tubes 4 disengage Do not disassemble the patient block before cleaning and sterilization 6 2 5 3 Cleaning 1 Pre cleaning submerge the patient block in an enzymatic solution within an ultrasonic tank for a period of 20 minutes 2 Clean the patient block in a washer disinfector unit that incorporates an initial cold rinse a detergent wash a decontamination stage at 92 C followed by a final drying stage 6 2 5 4 Sterilization 1 Sterilize as recommended in section 6 3 Do not disassemble 6 2 5 5 Reassembly 1 Position the patient block and push fully into the control unit ensur
31. URE alarm should activate 3 Reconnect the mains power cable to the AC outlet The alarm 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 Note that the bellows assembly is built into the A200SP Absorber _ please refer to the user manual for this product 57 PRE OPERATION PROCEDURES O2 Monitor 5 3 O2 Monitor System Set up 5 3 4 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 anesthetic 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 anesthetic machine to cut off the basal flow through the system Bacterial Fi
32. YPE tidal 13 Calibrate Touchscreen CALIBRATE TOUCH SCREEN The introduction screen allows the cauerate Touchscreen user to calibrate the screen Keep this Datasheet with the User Instruction Manual for AV S at all times 2 2 2 3 2 4 Parameter Display Identification Active Parameters Active parameters that can be set for use in the current mode are displayed as White Text on Blue Inactive Parameters Inactive parameters that can be set for any non current mode are displayed as White Text on Blue Label White values on Black Measured Parameters Yellow values on Black T PS INIT target and pressure support initial value The initial pressure value can be changed so that when entering either PRESSURE or PSV modes the TARGET value or PSUPP value are pre selected NOTE Changing either of these limits in their active modes will maintain the value when changing between PSV PRESSURE and STANDBY modes Gas Mixture The Gas Mixture window is an active touch selectable area in any mode with a drop down menu Gas Mixture is also available through the menu structure Selection of the required mixture is in the normal way with the scroll wheel Using the Ventilator description of modes and functions 4 4 1 Modes Access to Support Modes Access is available in Standby mode depending on the support mode options on the ventilator Support Mode a PSV b SIMV
33. ambient pressure and adjusts the delivered volume accordingly NOTE Altitude compensation is automatically applied during calibration of the oxygen monitor see section 5 3 2 19 DESCRIPTION 3 6 Interface to Integra AV S and A200SP Absorber The AV S is designed to interface with the Integra AV S Anesthetia Machine and the A200SP Absorber 3 6 1 Integra AV S Interface The interface cable links the socket A on the control panel to a socket on the rear panel of the anesthetic machine a Turm the anesthetic machine Gas Delivery Switch to ON The ventilator will power up b While the anesthetic 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 anesthetic 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 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 as follows i Ventilator in Volume or Pressure mode Switching the absorber Bag Vent contro
34. arried out by trained technicians Service and repair operations must only be carried out by an engineer trained by the manufacturer The warranty for this product is void if the product is not maintained in accordance with the service schedule detailed in section 6 1 and the procedures published in the Service Manual for this product Control Unit 29 Opening the control unit by unauthorized 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 30 31 32 33 For continued protection against fire hazards any replacement fuses must be the identical type and rating as the original components Replacement must be carried out by trained technician See section 4 for fuse rating 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 prox
35. be 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 NOTE Disconnection of airway pressure tubing or pressure sensor malfunction Message displayed Check pressure sensing Action by user Check the condition of the tubing and the connection at the ventilator A and the rear of absorber C If the tubing is undamaged and the connections are secure the operation of the sensors must be checked by a service engineer CAUTION The ventilator will continue to function although the target pressure may be exceeded by up to 10 cmH20 51 PRE OPERATION PROCEDURES 5 1 12 Leak Test Compliance Value Calculation This procedure checks the breathing system for pressure leakage and calculates and displays Leak Status Leak Level and Breathing System Compliance 1 Occlude the breathing circuit at the patient Y piece 2 Ensure that the absorber is switched to vent mode and the bellows are fully inflated 3 Either a disconnect the fresh gas hose from the CGO and connect it to the end of the bag arm or b Turn the anesthetic machine gas flow off at the gas delivery on off switch 1 This will stop all gas flows including oxygen basal flow and will also turn the AVS off Then switch the AV S on 2 at the ventilator Do not use
36. ble anesthetic agents There is a possible fire or explosion hazard Anesthesia apparatus must be connected to an anesthetic 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 scavenging transfer and receiver system must conform to ISO 8835 3 18 19 20 21 22 23 24 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 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 anesthesia 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
37. cations in EN 285 and the safety specifications in EN 61010 Part 2 041 Sterilization must be achieved by direct contact with good quality saturated steam Post processing Following reprocessing the patient block must be kept in a sterile plastic pouch to avoid being re contaminated prior to being fitted to the ventilator Refit in accordance with section 6 2 5 5 Function test the ventilator before clinical use see section 5 2 1 64 MAINTENANCE 6 4 Oxygen Sensor Replacement These operations must be carried out by suitably trained technicians only WARNING The sensor contains A Asmall 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 4 1 Sensor Unit Remove and Refit Replacement parts 102714 Sensor 1 Detach the cable connector 1 from the sensor 2 2 Unscrew the sensor from the A200SP Absorber and discard 3 Discard the expired sensor 4 Screw the new sensor 2 into the absorber 5 Attach the cable connector 1 6 Fit the assembly into the absorber 7 Calibrate the new sensor see section 5 2 1 8 Dispose of the used components according to hospital local state and federal regulations 65 7 APPENDIX
38. d in the event of damage or non functioning of the spirometer heads turn off the spirometry function see MENU function section 3 5 B 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 49 PRE OPERATION PROCEDURES 5 1 10 2 Spirometer Zero Calibration Flow sensors fitted to an A200SP Absorber mounted on a Integra AV S The Spirometry sensor heads must be calibrated with zero flow going through them The individual spirometers must be matched to the specific AVS ventilator by a qualified service engineer as part of commissioning or a subsequent service visit The following procedure defines the zero calibration which should be performed by the user as part of the daily check procedure 1 10 11 12 13 Turn the anesthetic machine 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 Turn the AV S on at the ventilator Do not use the Integra AV S Gas Delivery switch or Disconnect the fresh gas hose from the CGO block on the anesthetic 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 recei
39. e eee 3 8 On screen Menus sss 3 9 Spirometry 2 83 999392 DODWGW EE ame Redes rev edu pe 3 10 Display Waveforms 3 11 Alarms 224224 RR RERURAGURTRQRURWUN EUER sade Rhea sada Sage ees 3 12 Oxygen Monitor soie EGG ROG Pesan pid X Pew eee 3 12 1 System Operation 20600 eee ede saa aper acd XU RR RES E ee 3 12 2 The Oxygen Sensor sanie eb teh ehh ee PPP Pg weed de de 3 12 3 MONS scan pd ded pn RE EG GEN GER RAN aust aka exa a RM RR UE 93 12 4 Display seien eR BI Re ee Se hee Be aie EXIGEN REI S125 Alarms nu Tc eae he pale A ea aku HOE Ore BAUR dah eh Sonu ale 3 12 6 Alarm Mute a u tss ED eee oA ee eet Ga eee es 4 SPECIFICATION 2 4 nnrir RARER EEEN aaa wakin hukaq ahua Ventilator ay skis dee ed ee ba ose sew RW Re AR BGS uad ARES Oxygen Monitor 0 2 000 ee iii Page No 1 2 7 13 13 14 15 15 16 17 18 20 21 21 21 24 25 26 26 27 28 29 30 31 31 32 33 33 33 34 35 35 36 37 40 CONTENTS 5 1 5 1 1 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 1 12 5 1 13 5 2 5 2 1 5 2 1 1 5 2 1 2 5 2 1 3 5 2 2 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 2 5 6 3 6 4 PRE OPERATION PROCEDURES Ventilator Set UP s u usia eR eR ER eee EG aaa eee RE RA 42 Mounting the Ventilator eee 42 Electrical Power Connections
40. e 19 105 1 Cable length 2 m 6 ft fully extended Sensor Type Galvanic fuel cell sensor 0 100 Life 1500000 O2 hours One year minimum in typical applications Interference Gases and Vapours in 30 Oxygen 70 Nitrous Oxide Interference Volume Dry Interference in 02 Nitrous Oxide 80 lt 1 Carbon Dioxide 5 lt 1 Halothane 5 lt 1 Enflurane 5 lt 1 Isoflurane 5 lt 1 Sevoflurane 5 lt 1 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 10 at the sensor inlet will produce a 10 increase in sensor output NOTE Altitude compensation is automatically applied during calibration 41 5 PRE OPERATION PROCEDURES 5 1 Ventilator Set up WARNING Before the AV S ventilator is used clinically for the first time a Calibration Check and Output Check must be successfully completed Calibration and o
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42. e initial system self test has detected that a service calibration is required A full system calibration must be carried out by qualified service personnel The boxes will remain visible until calibration is completed The ventilator may still be used but with reduced accuracy 55 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 show that the battery is being charged it is not necessary to turn on the ventilator v gt HU PRE OPERATION PROCEDURES 5 2 1 3 Function Test 1 Set the AIRWAY PRESSURE LIMIT to 50 cmH20O 2 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 3 Connect a 2 litre breathing bag to the patient connection as a test lung 4 Adult bellows only Set the tidal VOLUME to 600 ml RATE to 10 bpm and I E RATIO to 1 2 0 5 Use the O2 flush button on the anesthetic machine to fill the bellows 6 Select VOLUME CYCLE mode 7 The delivered tidal
43. e 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 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 corresponds 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 showing typical hysteresis between up and down flow measurements and repeatability Resistance cmH2O 5 4 3 2 1 0 a I 0 20 40 60 80 100 120 140 Fl
44. ed volume will consist of the volume delivered from the ventilator bellows plus the fresh gas flow from the anesthetic 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 the measured volume is 5096 above or below the set volume This function is user adjustable Compliance Compensation Please refer to section 3 5 4 Altitude Compensation This function monitors ambient pressure and adjusts the delivered volume accordingly Vm SET V n MEAS SET mL i BPM 00 10 Volume Mode Parameters Tidal volume Rate E ratio PEEP Off or adjustable Inspiratory pressure limit Inspiratory pause does not affect I E ratio Sigh 21 SET LE 2 Gas Mixture O gt air 02 105 PRESSURE CONTROL VOLUME CONTROL SPONT MODE STANDBY PEEP LIMIT cmH20 cmH20 OFF 38 20 1600 mL 4 100 bpm 1 0 3 1 8 4 20 cmH2O 10 to 100 cmH2O 25 Approximately 1 5 x Set Vt is delivered once twice three times or four times every 50 breaths user selects frequency DESCRIPTION 3 7 2 2 Select Volume Mode Volume Mode selected from Standby Mode 1 Press the screen tab VOLUME CONTROL Volume Mode selected from Pressure Mode 1 Press the screen tab VOLUME CONTROL The ventilator continues to ventilate in Pressure Mode 2 The Volume Set display shows the previous setting or default setting
45. election 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 near as possible under the circumstances Accuracies for spirometry measurement are lt 100 ml 50 gt 100 ml 20 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 airflow or other gas flow through the inlet and outlet ports of the unit 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 a 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 Laser trimmed thick film and thin film resistors provide consistent interchangeability from one device to the next 72 The microbridge mass airflow sensor uses temperatur
46. ensor to high temperatures If the sensor shows signs of being affected by condensation dry the sensor with soft lissue Do not use heat to dry the sensor NOTES yj 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 anesthetic 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 pediatric patients under general anesthesia In addition in spontaneous mode it can be used to monitor spontaneously breathing patients It is designed for use in closed circuit anesthesia Indications for use of the device The AV S Ventilator is intended to provide continuous mechanical ventilatory support during anesthesia The ventilator is a restricted medical device intended for use by
47. eously breathing patients ONLY If the patient makes no attempt to breathe the ventilator will not provide support and the apnoea alarm will be activated 28 DESCRIPTION 3 7 5 4 PEEP Positive End Expiratory Pressure The AV S ventilator includes a microprocessor controlled electronically integrated PEEP system regulated by the secondary pressure on the exhaust diaphragm see 3 2 The ventilator controls PEEP by allowing flow from or delivering flow into the bellows drive circuit thereby maintaining the set pressure NOTE 1 PEEP is electronically controlled 2 PEEP is variable from 4 20 cmH20O in increments of 1 cmH20 3 The display shows OFF when PEEP is not in use 4 PEEP is switched off when the ventilator is switched off 5 PEEP is switched off during Spont mode to minimise patient s breathing effort Selecting PEEP 1 Select by touching the screen tab PEEP or using the navigator wheel The setting will flash 2 Rotate the navigator wheel to set the required PEEP pressure A confirm message will be displayed 3 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 Switch the ventilator to Volume Ventilation Mode 2 Select PEEP and set pressure to the required level The PEEP display indicates pressure 3 Switch the A200SP Absorber Bag Ven
48. essure 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 Mounting Remote arm mounted as illustrated 1 or optional combined control unit screen see section 5 1 1 Bellows unit The bellows unit 2 is built into the A200SP absorber A pediatric bellows assembly is available as an option Drive gas supply The drive gas supply can be oxygen or air The supply must be at 310 to 689 kPa 45 to 100 psi Note that the drive gas is specified by the customer and set during manufacture Conversion from one drive gas to another must only be carried out by an authorized service engineer trained by the manufacturer Spontaneous Mode Patient Support SIMV Synchronised Intermittent Mandatory Ventilation SMMV Synchronised Mandatory Minute Ventilation PSV Pressure Supported Ventilation PEEP Positive End Expiratory Pressure DESCRIPTION Control Unit Rear Panel Gas Connections 1 Ventilator drive gas inlet connect to anesthetic machine auxiliary gas out
49. etist There can be considerable variation in the effect of anesthetic drugs on individual patients so that the setting and observation of control levels on the anesthesia systems does not in itself ensure total patient safety Anesthesia system monitors and patient monitors are very desirable aids for the anesthetist but are not true clinical monitors as the condition of the patient is also dependent on his respiration and the macte hiim JDBIONS Mang Ue functioning of his cardio vascular system apparatus 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 Before using any monitoring system or device the user must check that it conforms to the relevant standard as listed in the table below Parameter Device Relevant Standard Pressure Measuring ISO 8835 2 Pressure Limitation Device EN 60601 2 13 2006 51 101 1 Exhaled Volume Monitor EN 60601 2 13 2006 51 101 4 Breathing System Integrity Alarm System EN 60601 2 13 2006 51 101 5 Continuing Pressure Alarm EN 60601 2 13 2006 51 101 6 Oxygen Monitor ISO 7767 Carbon Dioxide Monitor ISO 9918 Breathing Circuit ISO 8835 2 Agent Monitor ISO 11196 Gas Scavenging ISO 8835 3 For information on installing and connection of any of these systems or devices please refer to the relevant manufacturer s instructions
50. g b Annual two year four year service inspection and function testing and component 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 DRE Inc Technical Support DRE Inc 1800 Williamson Court Louisville KY 40223 USA Tel 502 244 4444 Fax 502 244 0369 Web www dremed com Always give as much of the following information as possible Type of equipment Product name Serial number Approximate date of purchase Apparent fault m Row FOREWORD This manual has been produced to provide authorized personnel with information on the function routine performance and maintenance checks applicable to the AV S Anesthesia 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 which may affect instructions in this manual without giving prior notice Personnel must make themselves familiar with the contents of this manual and the The Importance of Patient Monitoring WARNING Anesthetic 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 anesth
51. he 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 O2 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 O2 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 10096 HIGH ALARM SET 105 LOW ALARM SET 18 SPIROMETER on SPIRO CALIBRATION 0 L min DESCRIPTION O2 Monitor High Alarm Set Value Measured O2 Low Alarm Set Value concentration 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
52. iled in this section 2 Other procedures detailed in this section must be carried out by trained technicians only 3 Service and repair operations must only be carried out by an engineer trained by the manufacturer The warranty for this product is void if the product is not maintained in accordance with the service schedule detailed below and the procedures published in the Service Manual for this product 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 valve 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 12 v 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 6
53. imity to medical gas distribution components There is a risk of fire or explosion Exterior panels must not be removed by unauthorized personnel and the apparatus must not be operated with such panels missing There is a possible electric shock hazard Bellows Assembly 34 The valve seat on the patient gas exhalation diaphragm valve in the base of the bellows assembly must be cleaned regularly Note that the bellows assembly is built into the A200SP Absorber please refer to User Manual for this product 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 not sterilize the ventilator control unit The patient block assembly must be removed from the control unit before sterilization see section 6 2 5 All other internal components are not compatible with sterilization techniques and damage may result 2 For ventilator components which require sterilization peak sterilization temperatures should not exceed 1349C 2750F to prevent possible damage See section 6 3 Care
54. ing that the metal tubes 4 are engaged in their unions 2 Fit the securing knobs 3 6 2 5 6 Pre use Checks 1 Function test the ventilator before clinical use see section 5 2 1 63 eo me MAINTENANCE 63 Sterilization These operations must be carried out by suitably trained technicians only CAUTION To prevent possible damage to components peak sterilization temperatures must not exceed 1349C 2759F for steam autoclave Do not sterilize the ventilator control unit Apart from the patient block assembly the internal components are not compatible with sterilization techniques and may be damaged 6 3 1 Recommended Sterilization Parameters 6 3 1 1 Control Unit Patient Block Assembly 1 Clean as described in section 6 2 5 3 2 Autoclave at 1349C for a holding time of 3 5 minutes using packaging and equipment as listed below Packaging Pack the control unit with material which is permeable to air and steam but has an effective maximum pore size which is small enough to exclude microbial contamination All wrapping materials must comply with EN 868 Packaging Materials for Sterilization of Wrapped Goods Processing Equipment The sterilizer must comply with the stated performance class BS 3970 and HTM 2010 and with additional requirements stated in Section D If a porous load sterilizer is used it must conform to the specifi
55. is function is 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 compensation 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 40 60 mixture of O2 N2O is assumed 18 DESCRIPTION Compliance compensation The ventilator will apply compliance compensation to account for compliance loss in the breathing system in cases where i Fresh gas compensation is disabled or ii Spirometry is unavailable or disabled IMPORTANT For correct operation the value of the breathing system compliance must be established first by completing the ventilator leak test as part of the Pre operation Procedure Refer to section 5 1 12 noting that breathing system compliance is displayed as Bsys comp If the leak test is not carried out the default value will be used NOTE In compliance compensation mode any fresh gas used will be in addition to the set tidal volume Altitude Compensation This function monitors
56. l 502 244 4444 Fax 502 244 0369 Web www dremed com PATIENT LOG MENU ESCAPE FROM MENU PRINT PATIENT DATA LOGGING off LOG STATUS disabled CLEAR LOG DATA LOGGING WINDOW 10 min SITE DEFAULTS ESCAPE FROM MENU SAVE TO SITE VIEW SITE DEFAULTS VOLUME TYPE tidal Vt SET 550 ml Vm SET 5 5 Litres T PS INIT 10 cmH2O SET BPM 10 KE 1 1 0 PEEP OFF LIMIT 38 cmH2O TRIGGER 10 L min APNOEA ALARM LIMIT 15 Sec BACK LIGHT LEVEL 50 CLOCK MENU ESCAPE FROM MENU Clock pick list YEAR 2005 2005 2099 MONTH 3 1 12 DATE 16 1 31 HOUR 9 0 23 MINUTE 57 0 59 UPDATE CLOCK DAYLIGHT SAVING off off on UPGRADE MENU ESCAPE FROM MENU I O HARDWARE 2 I O FIRMWARE vx xx Build xx MAIN FIRMWARE vx xx Build xx REGISTRATION KEY unknown UPGRADE FIRMWARE unavailable ADD NEW FEATURE unavailable DISPLAY HISTORY 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 integer integer integer integer integer integer toggle option 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 testin
57. l from Vent to Bag the ventilator will change from Volume Mode or Pressure Mode into Spontaneous Mode Ventilator in Spontaneous Mode Switching the absorber Bag Vent control from Bag to Vent Note that the mode switching operation is dependant on the original selection process used to reach Spontaneous Mode A If the ventilator was previously in Volume or Pressure or Special Mode and Spontaneous Mode was automatically selected by the operation of the bag vent control from Vent to Bag as described above the ventilator will now revert to that previous mode B If the ventilator was in Standby Mode and Spontaneous Mode was selected on screen the ventilator will revert to Volume Mode NOTE a operation of the absorber Bag Vent control will have no effect on the ventilator unless the above conditions are met b This function can be enabled disabled through the on screen Service sub menu see appendix 20 DESCRIPTION 37 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 Oxygen Negative pressure Incorrect Rate Ratio Continuous high pressure 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 The delivered volume is adjusted by up to 6096 This deliver
58. let 2 Bellows Drive Gas Output connect to bellows via A200SP absorber see section 5 1 5 3 Outlet Exhaust Valve connect to scavenge system see section 5 1 6 Electrical Connection 4 Electrical mains input and fuse unit Interface and Parameter inputs 5 A200SP Absorber Bag Vent switch interface and Spirometer connector Integra AV S Interface connector primary on off switch 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 manufacturer s use only 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 your distributor s service department or the manufacturer DESCRIPTION 32 Ventilation Cycle This section provides a simplified description of the ventilation cycle 1 Inspiratory Phase The drive gas proportional valve 1 in the control unit opens Drive gas is delivered to the bellows housing 2 The patient proportional valve 3 opens and gas flows through the bleed valve The back pressure ensures that the exhaust valve 4 is kept closed Drive gas pressure builds up above the bellows 5 which starts to move down The diaphragm 6 in the bellows assembly base is held closed and patient gas is forced out of the bel
59. lows base 7 into the breathing system 2 Beginning of Expiratory Phase The drive gas proportional valve 1 closes The patient proportional valve 3 closes The exhaust valve 4 opens Patient gas returns to the bellows 5 As the bellows rises redundant drive gas is pushed out through the exhaust valve DESCRIPTION 11 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 6 lifts and allows gas to exit through the exhaust valve 4 4 PEEP Positive End Expiratory Pressure user selectable The patient proportional valve 3 applies PEEP pressure plus 20 cmH2O 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 5 will cause gas to bleed past the exhaust valve 4 Ifthere is a fall in pressure in the breathing circuit the continuous flow from the drive gas proportional valve 1 helps maintain the set PEEP pressure DESCRIPTION A Pneumatic Flow Diagram 0 90 cmH2O 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
60. lter Use a breathing system bacterial filter in the expiratory limb of the breathing circuit to protect the oxygen sensor see section 5 1 9 CAUTION Replacement Disposal always 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 NOTE Altitude compensation is automatically applied during calibration We recommend calibration with a 10096 oxygen standard source at a pressure and flow similar to your application 58 PRE OPERATION PROCEDURES O2 Monitor 5 3 2 1 Calibration Using 100 Oxygen AV S ventilator mounted on a Integra AV S anesthesia 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 anesthetic machine gas delivery switch The oxygen monitor automatically switches ON when the ventilator is switched on Ensure that all vaporizers
61. m settings 4 Alarm mute switch 30 second or 120 second alarm silence depending on alarm status Note also that some alarms are not mutable see 3 11 5 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 6 Active Tabs Touch the screen at the appropriate tab area to activate the required function parameter 15 DESCRIPTION 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 2 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 Tidal Volume Range 20 1600 ml Rate 4 100 bpm I E Ratio 1 0 3 to 1 8 PEEP 4 20 cmH20 Can be set to OFF Pressure Limit Volume mode 10 80 cmH20 Pressure mode 10 50 cmH2O Alarm limits user adjustable alarms only see 3 11 16 DESCRIPTION 3 5 3 Operational Capability Tidal Volume Rate and E ratio settings are all limited by a maximum inspiratory flow of 75 L min and a minimum flow
62. must be taken not to let any liquid run into the control unit serious damage may result 4 The exhalation valve located in the bellows base assembly and the pediatric bellows adaptor must be cleaned and sterilized separately Note that the bellows assembly is built into the A200SP Absorber please refer to User Manual for this product 5 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 Note that the bellows assembly is built into the A200SP Absorber please refer to User Manual for this product 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 functioning 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 O2 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 desig
63. n at the very end of its life Typical sensor drift rates are less than 1 per month when the sensor is exposed to gas in typical applications Sensor life approximately 1500000 02 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 33 O2 Sensor Location Integra AV S with A200SP Absorber DESCRIPTION O2 Monitor 3 12 3 O2 Monitor sub menu ON OFF Turn the navigator wheel to switch between ON and OFF Press to confirm Scroll to 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 t
64. n selection is set correctly for the drive 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 The driving gas is discharged through the opening in the back of the ventilator control unit 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 anesthetic 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 anesthetic ventilator and therefore cannot be directly under the control of the anesthetic ventilator manufacturer However we strongly recommend that only breathing systems which have been approved and authorized by the manufacturer for use with AV S should be employed Do not u
65. nate 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 Note that the sensor for the oxygen monitor is built into the A200SP Absorber for additional information please refer to the A200SP User Manual WARNINGS 1 We recommend calibration of the oxygen monitor every time the system is 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 The oxygen sensor is not suitable for sterilization If contamination is suspected fit a new sensor see section 6 4 and dispose of the contaminated unit according to hospital local state and federal regulations CAUTIONS f Do not sterilize any oxygen monitor component Do not autoclave or expose the s
66. nts of this manual and the machine s function before using the ventilator Before Using the Ventilator 2 Before the AV S ventilator is used clinically for the first time a Calibration Check and Output Check must be successfully completed Calibration and output checks must be carried out by a DRE trained technician following the procedure in Appendix 6 in the AV S Service Manual Before the ventilator is used clinically for the first time verify that the hospital engineering department has carried out an earth continuity test If the integrity of the protective conductor is in doubt the ventilator must not be used 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 The drive gas is set during manufacture and the ventilator is calibrated for that gas 10 Before the ventilator is used clinically for the first time the commissioning engineer must confirm that the air oxyge
67. nu is ESCAPE FROM MENU VOLUME TYPE Tidal SIGH ENABLE 2 SIGH TO BREATH RATIO INSP PAUSE 0 In PRESSURE mode and PSV modes the SPECIAL MODES menu is ESCAPE FROM MENU SIGH ENABLE 2 SIGH TO BREATH RATIO INSP PAUSE 0 Notes 1 2 3 2 Support mode depends on configuration options The SUPPORT MODE option will be missing from the SPECIAL MODE menu if a Options are not enabled b SPIROMETRY off is displayed The support mode sub menu can include none PSV SIMV SMMV The options here are 0 60 The options here are on off 1 10 to 1 100 Note 1 10 indicates 1 breath with sigh then 10 breaths without sigh The TRIGGER values are L min with SPIROMETRY enabled or cmH20 when SPIROMETRY disabled Spirometry enabled Spirometry disabled 0 7 L min 0 5 cmH20 0 8 L min 0 6 cmH20 0 9 L min 0 7 cmH20 1 0 L min 0 8 cmH20 1 5 L min 0 9 cmH20 2 0 L min 1 0 cmH20 2 5 L min 1 2 cmH20 3 0 L min 1 5 cmH20 3 5 L min 1 7 cmH20 4 0 L min 2 0 cmH20 SERVICE MENU Service ESCAPE FROM MENU LANGUAGE ENGLISH PATIENT LOG MENU SITE DEFAULTS SERIAL MODE none ABSORBER SWITCH ON CLOCK MENU UPGRADE MENU AMBIENT PRESSURE 988 mBar DISPLAY HISTORY SERVICE PIN 0 ENGINEER MENU NOTE Sub menus for Service PIN and Engineer Menu are not accessible by users Doc No AVS 0408DS U September 2008 DRE Inc 1800 Williamson Court Louisville KY 40223 USA Te
68. o 1600 ml x1096 Pediatric bellows 20 to 350 ml 10 At ambient temperature of 20 C 10 and ambient atmosphere of 101 3 kPa 10 Minute Volume 0 to 30L Rate 4 100 bpm 1 E Ratio 1 0 3 1 8 10 100 cmH2O Automatic Tidal Volume adjustment Pressure Limit Fresh Gas Compensation Modes Off Standby Volume Cycle Pressure Controlled Spontaneous includes advanced breathing modes 10 70 cmH20 2 70 L min Pressure Control Inspiratory Flow Active Volume and Pressure Alarms Advanced Breathing Modes selectable see section 4 6 Spontaneous Mode Electronic PEEP 4 20 cmH20 Spirometry Resolution 10 ml Ventilator Performance accuracy of delivered volumes lt 100 ml 50 gt 100 ml 20 NOTE The ventilator is designed for use with Spirometry ON Accuracy of delivered volumes with Spirometry OFF may vary from the figures given above 38 SPECIFICATION 4 6 Advanced Spontaneous Breathing Modes SIMV SMMV PSV Trigger PEEP Referenced Trigger Window Vt and Vm Insp Time Ti Support Pressure Default settings 0 7 to 4 L min Set 60 of Expiratory Time As Volume Mode 0 5 to 5 secs 3 to 20 cmH2O Volume Vt BPM E Pmax Adult 600ml 10 1 2 38 cmH2O Pediatric 150 ml 15 1 2 38 cmH2O Pressure Vt BPM E P target Adult 600ml 10 1 2 10 cmH20 Pediatric 150 ml 15 1 2 10 cmH2O SIMV Vt BPM Insp time Trigger Adult 600ml 6 2 sec 1 L min Pediatric 200 ml 10 1 sec 1 L min SMMV Vm B
69. o Integra AV S On Off switch and A200SP Bag Vent switch 44 PRE OPERATION PROCEDURES on O mm gt O N gt PO PO DM PDH NM S c c c cc c c CO PWN RODAN DAP WN RS 25 26 27 28 29 30 31 Bellows Ventilator Control Unit Outlets to Anesthetic Gas Scavenging System AGSS Bacterial Filter Absorber valve block Heat and moisture exchanger a combined unit with a bacterial filter can be used see 5 1 9 Patient CGO Block on anesthetic machine Fresh Gas Supply Auxiliary Outlet on anesthetic 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 Integra AV S interface SP on off switch Input socket i A200SP Absorber Bag Vent control position ii Spirometer sensor signal Interface connections on Integra AV S and A200SP APL Valve Outlet from APL Valve to AGSS Oxygen sensor Remote screen unit Cable control unit to screen 45 PRE OPERATION PROCEDURES Control Unit Rear Panel Gas Connections 1 Ventilator drive gas inlet connect to ane
70. odes Select Support Mode Select SIMV Escape Menu SIMV will be displayed on the main screen when Spontaneous mode is selected or triggered NOTE 1 The trigger window is pre set to 6096 of the BPM cycle time 2 The trigger is flow activated 3 If Spirometry is disabled then SIMV is not available 4 If the pressure limit and alarm are activated the inspiratory phase is terminated Activate SIMV during Ventilation NOTE SIMV will not function unless already pre selected in Standby Mode 1 Select Special Mode on the display If the absorber Bag Vent switch is not detected a message will appear SET ABSORBER TO VENT Press the navigator wheel push button to confirm 2 Move the absorber Bag vent switch to Ventilator 3 Check that SIMV is functioning correctly SIMV Default Settings The ventilator will default to pre set values for Tidal volume Vt Rate Inspiratory Time and Trigger Level after selecting SIMV Note 1 Vt can be adjusted before SIMV is confirmed 2 The trigger setting is adjustable between 0 7 and 4 0 L min PEEP J 0 cmH2O SIMV Spontaneously Breathing Patient A Cycle Time set from BPM B Trigger Window C Spontaneous Breath D Trigger E Mandatory breath at the set tidal volume Vt Inspiratory flow in the Trigger Window generated by the patients spontaneous breath results in a synchronised mandatory breath at a preset volume and rate
71. of 2 L min Tidal Volume litres Vt LE Ratio 1 6 15 1 4 1 3 1 2 1 1 1 0 3 0 9 0 8 0 7 0 6 0 5 0 4 0 3 0 2 0 1 0 10 20 30 40 50 60 70 80 Rate bpm The ventilator is capable of operating at the volumes and rates below each I E ratio curve Example f Select required volume Vt 1 0 L 2 Select rate 20 bpm In this example the point of intersection X on the graph shows that an I E ratio can be set from 1 0 3 to 1 4 as these curves are all above the intersection point Similarly a ratio of 1 5 cannot be set as this is below the intersection point 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 An alarm is triggered if the measured volume varies by 50 from the set volume Th
72. onfirm 4 To exit 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 touchscreen 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 further information on the Menu system 30 DESCRIPTION 39 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 Modes are disabled See Appendix 3 for a detailed description of the spirometry system 3 10 Display Waveforms NOTE 1 The default waveform is always Pressure v Time cmH2O v seconds 2 Wave Freeze is available when ventilation is in progress Second waveform The second waveform can be displayed by using the menu control or by touching the waveform on screen Select from 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 The scale adjusts as Plimit is changed 20 to 40 60 80 cmH20 b In Vol v Time mode the scale adjusts as Vt is changed 0 to
73. ow L min APPENDIX APPENDIX 4 Disposal at end of useful life risk assessment Do not dispose of in landfill refer to an approved recycling facility Follow your hospital local state and federal regulations EC territories Follow the requirements of Directive 2002 96 EC Note Disposal of used batteries see Appendix 1 APPENDIX 5 Approved Accessories WARNING Only use accessories approved by DRE Inc 57655 Compact Pressure Tee 57523 Pressure sensing tube 57545 Adult Bellows and base canister 57551 Adult Canister 57550 Adult Bellows 57548 Bellows Base 57656 Bellows base manifold block Additional to bellows base use on stand alone unit 57553 Pediatric Canister 57552 Pediatric Bellows 57554 Pediatric Bellows Adaptor Sales Tel 502 244 4444 Fax 502 244 0369 Web www dremed com 73 C 0473 Copyright DRE Inc 2008 All rights reserved Cat No 52967 Doc No AV S A2 0208UI September 2008 Sold by DRE Inc 1800 Williamson Court Louisville KY 40223 USA Technical Support amp Sales Tel 502 244 4444 Fax 502 244 0369 Web www dremed com
74. oxygen or air 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 B Pneumatic Control Manifold Block 7 Drive Gas Proportional Valve 8 Drive Gas Flow Sensor 9 Drive Gas Pressure Sensor 10 Low Pressure Regulator 11 Patient Proportional Valve 12 PEEP pressure sensor 13 Restrictor The restrictor allows a flow of up to 2 L min lt 2 L min bleeding C Exhaust Manifold Block 14 Check Valve 15 Diaphragm Valve 16 Pressure Relief valve Set to 1
75. port on the control unit to a properly functioning scavenging system Use a 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 Therefore the scavenging system must not generate more than 0 5 cmH2O positive or negative pressure when connected to the ventilator Any problem arising from an improperly functioning scavenging system is solely the user s responsibility 47 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 5 1 8 Printer Attach a printer to the printer port 2 if a printed output of the ventilator function is required 5 1 9 Breathing System 1 Connect the ventilator bellows base BREATHING SYSTEM port to the breathing system 2 a Use a brea
76. qualified trained personnel under the direction of a physician Specifically the ventilator is applicable for adult and pediatric patients The ventilator is intended for use by health care providers i e Physicians Nurses and Technicians with patients during general anesthesia 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 anesthesia and is intended for adult and pediatric 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 anesthesia 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 Ventilation Modes Volume Mode continuous mandatory ventilation Pressure Mode pressure controlled ventilation Spontaneous with advanced patient support SIMV SMMV PSV PEEP Patient Monitoring Airway pr
77. r For additional information please refer to the user manual for that product 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 5 2 1 1 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 authorized service technician Alarm System 5 2 1 2 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 Integra AV S see section 3 5 2 a Turn the anesthetic machine Gas Delivery Switch to ON the ventilator will power up While machine power is ON the Ventilator can be turned OFF and ON using the ventilator On Off switch Test Display Two small boxes A and B appear on the left hand side of the screen showing either Top box BLACK lower box GREEN Indicates the initial system self test has been completed successfully The boxes will be removed from the screen as soon as the ventilator is taken out of standby mode Top box RED lower box BLACK Indicates that th
78. r 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 DRE Inc 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 Canada 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 this ventilator WARNINGS General Information 1 Personnel must make themselves familiar with the conte
79. ra volume for 1 to 4 breaths in 50 the user can select 1 2 3 or 4 breaths The extra volume will be approximately 50 above the tidal volume set by the user Note that the High Volume Alarm is not triggered when Sigh is selected Select Sigh function Press the Menu switch Select Special Modes Select Sigh Enable on off Select Sigh to Breath Ratio Rotate the wheel to select required value Press wheel to confirm Exit menus The legend for Sigh will SIGH appear on the display Note that sigh function is cancelled when Standby is selected Volume measurement Volumes are measured if the Spirometry function is selected Automatic High or Low volume alarms are triggered if the measured volume is 50 above or below the set volume User adjustable option If the maximum pressure limit is achieved the ventilator cycles to the expiratory phase 23 DESCRIPTION 3 7 3 Pressure Mode 3 7 3 1 Parameters In pressure mode the ventilator delivers a flow 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 pediatric patients Inspiratory pressure 10 70 cmH20 Rate 4 100 bpm LE ratio 1 0 3 1 8 PEEP Off or adjustable 4 20 cmH20 Inspiratory decelerating flow is controlled by the ventilator according to the pressure setting There is no Inspiratory Pause function in pressure mode 3 7 3 2 Selecting
80. red to the patient This delivered volume will consist of the volume delivered from the ventilator bellows plus the fresh gas flow from the anesthetic machine fresh gas supply minus any compliance loss and minus any leak This gives a total actual inspired tidal volume 71 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 again 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 50 of set volume a low or high volume alarm is given Breathing System Gas Composition Gas flow measurements are affected by the composition of the breathing system gas To compensate for these effects the ventilator has a a gas composition setting whereby the user is able to select the gases being delivered i e oxygen air oxygen nitrous oxide etc b an oxygen
81. se 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 WARNINGS AND CAUTIONS 11 12 13 14 The spirometer sensors are mounted within the A200SP absorber Do not fit a spirometer sensor to any other location The device will not measure exhaled volumes in any other position 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 authorized 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 15 16 17 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 flamma
82. sthetic machine auxiliary gas outlet 2 Bellows Drive Gas Output connect to bellows on Integra AV S with A200SP absorber connect to absorber see section 5 1 5 3 Outlet Exhaust Valve connect to scavenge system Electrical Connection 4 Electrical mains input and fuse unit 46 Interface and Parameter inputs 5 A200SP Absorber Bag Vent switch interface and Spirometer connector 6 Integra SP I SP II Interface connector primary on off switch 7 Pressure Monitor Port 8 Input socket Oxygen monitor sensor Data and Printer Ports 9 Data Output 10 Output to remote screen 11 Ethernet 12 USB 13 VGA 14 Printer port 15 RS232 manufacturer s use only 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 your distributor s service department or the manufacturer PRE OPERATION PROCEDURES 5 1 5 Bellows drive gas hose 1 Integra AV S 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 Anesthetic Gas Scavenging System 1 Connect the EXHAUST valve
83. swoljleg uBiH eJnsseJg sec BAG swoljleg MOT eunssaeJg Ajddng sec eAug o1 i 4 0 noqy Jewog pexoolq jenno doul 1u A eneJedou 40je nuSA uue v 32 DESCRIPTION O2 Monitor 3 42 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 Always use a breathing system bacterial filter in the expiratory limb of the breathing circuit to protect the oxygen sensor and breathing system components from contamination 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 Oxygen Sensor The oxygen sensor offers quick response linear output over the entire 0 100 oxygen range and long service life The sensor 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 show
84. t control A to the Bag position The ventilator automatically switches to Spontaneous Mode PEEP is automatically switched off does not function in Spontaneous Mode PEEP display is blank 4 Reset the Bag Vent control Vent position The ventilator automatically switches to the mode previously set by the user PEEP is Off PEEP display indicates Off 5 Set the ventilator to Volume Ventilation Mode PEEP remains Off Select PEEP if required 29 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 LEAK TEST MENU FRESH GAS COMPENSATION ON SPECIAL MODES WAVEFORM ALARM SETTINGS GAS MIXTURE O2 AIR USER SETTINGS SERVICE MENU Menu Switch Turn the wheel to scroll through To Exit the menus Press the menu switch on the front panel or select Press to enter EXIT MENUS and press the wheel sub menu NOTE The menu window will not be displayed if A Control parameters VT MEAS BPM I E 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 gt 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 c
85. t switch to Ventilator 3 Check that SMMV is functioning correctly SMMV Default Settings The ventilator will default to pre set values for minute volume Vm Rate Inspiratory Time and Trigger Level after selecting SMMV Note 1 Vm can be adjusted before SMMV is confirmed 2 The trigger setting is adjustable between 0 7 and 4 0 L min PEEP 0 cmH20 SMMV Spontaneously Breathing Patient A Cycle Time set from BPM B Trigger Window C Spontaneous Breath D Trigger E Mandatory Breath tidal volume This is equal to Vm BPM minus the volume spontaneously breathed during the cycle this maintains the set Vm Inspiratory flow in the Trigger Window generated by the patient s spontaneous breath results in a synchronised mandatory breath ensuring that the set minute volume is achieved SMMV No breathing effort by Patient A Cycle Time set from BPM B Trigger Window C Flat Pressure Trace no breathing effort D Mandatory breath at the end of the Trigger Window at the set Vm If the patient makes no effort to breathe during a cycle a mandatory breath at the end of the trigger window will still be delivered at the preset volume and rate DESCRIPTION 3 7 5 3 PSV Pressure Supported Ventilation 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
86. t the ventilator power cord into the same electrical wall outlet or strip into which an electrocautery unit is connected 42 PRE OPERATION PROCEDURES 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 range 45 to 100 psi 3 1 6 9 bar 310 689 kPa OXYGEN SUPPLY a O2 cylinder b Anesthetic machine O2 auxiliary gas outlet c O2 pipeline supply from a wall outlet AIR SUPPLY a Air cylinder b Anesthetic 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 anesthetic 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 next page contains a schematic showing the cables and tubing for an AV S ventilator mounted on a Integra SP I SP Il anesthesia machine with an integral A200SP Absorber 43 PRE OPERATION PROCEDURES Hoses and Cables Schematic AV S with remote screen and A200SP Absorber Note 1 AV S has spirometry and oxygen monitor 2 Interface cabling is shown for connection t
87. the ventilator will use its pre calibrated delivery 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 method 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 The flow sensor output is read at least every 2 msec Five sets of readings are averaged and the averaged value is sent every 10 ms to the processor for calculation of the volume delive
88. the anesthetic machine gas delivery switch 4 Press the menu switch 3 Select LEAK TEST from the main menu Select lt START STOP LEAK TEST to start the leak test The ventilator will now drive gas into the absorber until a pressure of 30 cmH20 is obtained and then hold that pressure for approximately 25 seconds before releasing the pressure and completing the test 5 The menu will display the leak test results i Leak Status Excellent under 50 ml min Good between 50 and 149 ml min Poor between 150 and 349 ml min Bad 350 ml min or more NOTE The ventilator will still operate irrespective of the displayed Leak Status 52 Leak Test ESCAPE FROM MENU START STOP LEAK TEST LEAK STATUS unknown LEAK LEVEL 0 mL min BSYS COMP 7 0 mL cmH20 PRE OPERATION PROCEDURES ii Leak Level Indication of leak rate is displayed NOTE During the test any pressure drop discovered once the 30 cmH20 level is reached will be displayed as a possible leak by the ventilator self test This includes pressure drop due to the relaxation of any elastic components in the breathing system e g a breathing bag iii BSys Comp BSys Comp is the compliance of the breathing system and is the value that will be used in providing the default compliance compensation for volume delivery NOTE This value has an upper limit of 18 cmH2O sufficient for normal breathing system capacities 53 PRE
89. thing system bacterial filler 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 a combined HME bacterial filter can also be used but note that the expiratory limb bacterial filter is still required 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 anesthetic machine APL valve 48 PRE OPERATION PROCEDURES 5 1 10 Spirometer 5 1 10 1 Flow sensors fitted to an A200SP Absorber mounted on a Integra AV S 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 use
90. ty The AV S meets the requirements of EN60601 1 2 Electromagnetic compatibility requirements and tests MRI compatibility The AV S is not suitable for use in an MRI environment 4 15 Device Classification and Labelling Type B Applied Part Degree of protection against electric shock This symbol denotes Type B equipment Class 1 Classification Type of protection against electric shock Class 1 with internal electrical power source battery backup IPXO Ingress protection Classification according to the degree of protection against ingress of water IPXO not protected Labelling This symbol denotes Refer to the User Manual N 4 16 Oxygen Monitor Measurement Range 0 100 Resolution 1 Accuracy and Linearity 2 of full scale at constant temperature and pressure Response Time 90 of final value in approximately 10 seconds air to 100 O2 Operating Temperature 15 to 30 C 59 to 86 F Storage Temperature 5 to 40 C 23 to 104 F Relative Humidity Range 10 95 non condensing 40 SPECIFICATION Oxygen monitor continued Battery Back up As per ventilator High Priority Alarm Flashing 2x5 audio pulses with 6 seconds repeat time Medium Priority Alarm Flashing 3 audio pulses with 24 seconds repeat time Low Priority Alarm Static with single beep sound Alarm Mute 30 seconds for high priority alarm 120 seconds for medium priority alarm Low Alarm Set Range 18 99 196 High Alarm Set Rang
91. utput checks must be carried out by a DRE trained technician following the procedure in Appendix 6 in the AV S Service Manual 5 1 1 Mounting the Ventilator The remote screen is mounted on an adjustable arm with the control unit mounted at the rear or side of the anesthetic machine Location for optional control unit screen Preferably mount the unit permanently on the shelf of the anesthesia machine or on a strong bracket This will protect the unit from accidental fall and disconnection of hoses and cables To fit the 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 connec
92. ver 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 50 On Off Switch Alarm Mute Menu Switch Navigator Wheel and Press Button 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 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 PRESSURE 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 tu
93. www ardusmedical com AV S Ventilator User Manual Vm SET Vm MEAS SET inspTime PEEP LIMIT Lites ires E mHO HO EN 36 36 6 BEBE This manual contains information for software upgrade v 1 87 01 AV S Ventilator User Manual Software Version 1 87 01 Addendum to the User Manual Introduction AVS software V 1 87 01 introduces a new user interface However if you are familiar with the AV S please note that the basic operation and calibration procedures remain as per v 1 86 Modifications to the User Interface Setting up the Ventilator for use 1 Introduction Screen 1 4 Start up At start up the introduction screen allows the user to select one of three default settings SITE DEFAULTS ADULT DEFAULTS PEDIATRIC DEFAULTS NOTE a The user must select one of the above default groups before the ventilator will switch to standby in that default mode b SITE DEFAULT is editable in standby mode see section 1 2 below c Settings can be saved via the service menu to create a new site default 12 Default Settings 1 2 1 Selection The user can select ADULT or PEDIATRIC or SITE and view the gt STE DEFALLTS lt default parameter settings The options will remain even after the ventilator is turned off 60 Litres 1 2 2 Site Default Settings Adjust the parameter values from within the Service menu SITE DEFAULTS Press to confirm the new settings for site defaults VOLUME T
94. yed 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 36 4 SPECIFICATION 4 1 Application 4 2 Internal Compliance Adult bellows Pediatric 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 Pediatric Ventilation for use in anesthesia 3 ml cmH2O nominal 2 ml cmH2O 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 pediatric available as option Power Fuse mains supply Battery Back up Fuse battery Drive Gas 4 4 Alarms Alarm Mute Apnoea Low Drive Gas Pressure High Continuous Airway Pressure Low Pressure Incorrect Rate or Ratio Mains Failure Low Battery Ventilator Inoperative Outlet Blocked 100 120 VAC 50 60

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