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Penlon AV-S User Manual

V.2 ventilator
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User Manual
AV-S v.2 Ventilator
A N A E S T H E S I A S O LU T I O N S

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Summary of Contents for Penlon AV-S

  • Page 1 User Manual AV-S v.2 Ventilator A N A E S T H E S I A S O LU T I O N S...

  • Page 3: Servicing And Repairs

    Details of these operations are given in the Service Manual for this ventilator, available only for engineers trained by the manufacturer. For any enquiry regarding the servicing or repair of this product, contact Penlon Ltd: UK and International Technical Support Penlon Limited...
  • Page 4 Foreword The Importance of Patient Monitoring This manual has been produced to provide authorised personnel with information on the function, routine performance and maintenance checks applicable to the AV-S WARNING Anaesthesia Ventilator. Anaesthetic systems have the capability to deliver mixtures...

  • Page 5: Table Of Contents

    Oxygen monitor ..................42 AV-S v.2 Ventilator...
  • Page 6 SUPPLEMENT AV-S for use with non-A200SP Absorber S1 Mounting options ..................72 S2 Gas ports and interface connectors .

  • Page 7: User Responsibility

    Should such a repair become necessary it is recommended that a request for service advice be made to Penlon Ltd. 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.

  • Page 8: Warnings And Cautions

    11. The data output, VGA, and printer ports must only be connected to equipment complying with IEC safety 2. Before the AV-S ventilator is used clinically for the first standards (e.g. IEC 60950) which are then configured to time a Calibration Check and Output Check must be comply with IEC 60601-1 (Medical Systems).
  • Page 9 (see section 5.3.1). independently from the ventilator. It is the responsibility of the user to monitor patient 21. The AV-S ventilator is not intended for use in intensive ventilation. care applications. 32. Care must be taken to ensure that the flow sensors are 22.
  • Page 10 Note that the bellows assembly is built into the A200SP Absorber - please refer to the user manual for this product. Failure to keep the valve seat clean could result in the diaphragm sticking, thus preventing exhalation. AV-S v.2 Ventilator User Manual...
  • Page 11 2. Do not autoclave or expose the sensor to high temperatures. 3. If the sensor shows signs of being affected by condensation, dry the sensor with soft tissue. Do not use heat to dry the sensor. AV-S v.2 Ventilator User Manual...

  • Page 12: Purpose

    It is designed for use in closed-circuit anaesthesia. Environment The AV-S Ventilator is suitable for use by a professional operator in a professional healthcare facility and must be continuously attended when in use. Do not use the device near HF surgical equipment, or outside...

  • Page 13: Description

    3. Description General Description • The AV-S Ventilator is a pneumatically driven, software controlled, multi-mode ventilator. • The ventilator is time-cycled, volume/pressure controlled, and pressure limited. • The ventilator has compliance compensation and fresh gas compensation. • User-selectable gas mixture compensation is a standard feature, plus a user-selectable variable inspiratory pause and sigh option.
  • Page 14 Interface and Parameter Inputs IEC 60601-1 (Medical Systems). 5. A200SP Absorber bag/vent switch interface, and spirometer connector 6. Prima series interface connector - (primary on/off switch) 7. Pressure monitor port 8. Input socket - oxygen monitor sensor AV-S v.2 Ventilator User Manual...

  • Page 15: Ventilation Cycle

    When the bellows is fully inflated, any redundant drive gas leaves the system through the diaphragm (6). If the pressure falls below the required PEEP value, the exhaust valve will close and the fresh gas supplied will increase the pressure maintaining PEEP. AV-S v.2 Ventilator User Manual...
  • Page 16 Description Pneumatic Flow Diagram 3 to 7 bar 241 kPa (35 psi) 0 - 80 cmH 0 - 90 cmH 100 cmH AV-S v.2 Ventilator User Manual...

  • Page 17: Pneumatic System

    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 drive gas supply of 280 to 600 kPa (41 to 87 psi) - oxygen or air, to customer requirements.

  • Page 18: Electrical System

    2. To isolate the ventilator from the mains power supply: Disconnect the mains cable from the hospital power outlet. AV-S control unit is mounted on Prima 450/460 anaesthetic machine 1. Connect the ventilator to the outlet (2) on the machine.

  • Page 19: User Interface

    Breathing modes: Touch the mode icon area (E) Area A Menu and sub-menu window Waveform display, pause and print symbols Area B Alarm values window Area C Gas mixture selection window Area D Oxygen monitor values window Area E Breathing mode symbols AV-S v.2 Ventilator User Manual...
  • Page 20 White text on Blue Label (3A) White values on Black (3B) 4. Measured Parameters Yellow values on Black 5. Breathing mode information symbols Adult mode Ventilator mode Sigh Paediatric mode Bag mode Inspiratory pause AV-S v.2 Ventilator User Manual...

  • Page 21: On-Screen Menus

    2. If another parameter is selected using the touchscreen, the menu is de-selected. 3. While any menu is selected: a) the alarms are active the ventilator can be switched off See Appendix 4 for a further information on Menu structure. AV-S v.2 Ventilator User Manual...

  • Page 22: Start-Up Screens

    ADULT DEFAULTS I : E : 1: 2.0 PEEP : OFF VIEW Limit : 38 cmH2O Trigger : 1.0 L/min Apnoea Alarm Limit : 15 secs PAEDIATRIC DEFAULTS Volume Type: Tidal VIEW CALIBRATE TOUCH SCREEN AV-S v.2 Ventilator User Manual...

  • Page 23: Selecting Functions And Parameters

    PRESSURE mode or PSV (pressure supported ventilation) mode the TARGET value or PSUPP value are pre-selected. Note that changing either of these limits in their active modes will maintain the value when changing between PSV, PRESSURE, and STANDBY modes. AV-S v.2 Ventilator User Manual...

  • Page 24: Operational Capability

    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. AV-S v.2 Ventilator User Manual...

  • Page 25: Output Compensation Functions

    Description Output Compensation Functions WARNING The AV-S automatically compensates for fresh gas flow (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: 1.

  • Page 26: Compliance Compensation

    2. If shutdown was started in error, the user has the opportunity to quit the power down sequence and recommence ventilation. 3. Turn the anaesthetic machine Gas Delivery Switch to ON. The ventilator will power up and revert to Standby mode. AV-S v.2 Ventilator User Manual...
  • Page 27 (1). The sensor signal cabling is routed internally to connector (2), and the interface cable runs to the connector (3) at the rear of the AV-S control unit. Automatic Mode-switching: Bag Vent Control Operation of the Bag/Vent control will trigger automatic Mode switching on the AV-S ventilator, as follows: 1.

  • Page 28: Ventilation Modes

    The screen will display the previous ventilation mode, highlighted in yellow, within the relevant box. The last used parameters will also be displayed. • In Standby mode, the underline (1) indicates the last used ventilation mode AV-S v.2 Ventilator User Manual...

  • Page 29: Volume Mode

    Volume mode will commence at the beginning of an exhalation phase. 3.9.2.3 Volume Type Selection Touch the screen tab to switch between Tidal Volume and Minute Volume. NOTE Minute Volume is derived from a rolling average during a 30 MEAS AV-S v.2 Ventilator User Manual...
  • Page 30 Touch the screen in the area containing the green icons to display access mode configuration options (including INSP PAUSE, NOTE: SIGH, and APNOEA ALARM mute/inhibit). The sigh function is cancelled when standby is selected. See also, section 3.5. AV-S v.2 Ventilator User Manual...

  • Page 31: Pressure Mode

    Site Defaults have been selected with preset values. • A high inspiratory flow is used to achieve and maintain the target pressure. • The exhaust valve operates to prevent excess pressure. • There is no Inspiratory Pause function in pressure mode. AV-S v.2 Ventilator User Manual...

  • Page 32: Spontaneous Mode

    15, 30, 60, 120, or 180 seconds) through the alarm settings menu, or accessed by touching the alarm area of the screen. c) When the alarm mute is selected, the mute period is displayed on the screen, and count-down starts. AV-S v.2 Ventilator User Manual...
  • Page 33 Support modes are enabled at the factory, to the specification chosen by the customer. Support modes can be accessed through the display touchscreen function. • SIMV: Synchronised Intermittent Mandatory Ventilation • SMMV: Synchronised Mandatory Minute Ventilation • PSV: Pressure Supported Ventilation AV-S v.2 Ventilator User Manual...

  • Page 34: Advanced Spontaneous Breathing Modes

    D = Mandatory breath at the end of the trigger window at the set V 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. AV-S v.2 Ventilator User Manual...

  • Page 35: Smmv (Synchronised Mandatory Minute Ventilation)

    (at the set V 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 AV-S v.2 Ventilator User Manual...

  • Page 36: Psv (Pressure Supported Ventilation)

    C = Spontaneous breath results in a synchronised min. pressure supported breath PSV is used to support spontaneously breathing patients ONLY If the patient makes no attempt to breathe, the ventilator will not provide support and the apnoea alarm will be activated AV-S v.2 Ventilator User Manual...

  • Page 37: Peep (Positive End Expiratory Pressure)

    Description 3.9.6 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...

  • Page 38: Spirometry

    2. To exit the menu, scroll to EXIT MENUS and press the wheel. O2 Monitor & Spiro ESCAPE FROM MENU O2 MONITOR: on CALIBRATION: 100% HIGH ALARM SET: 105 LOW ALARM SET: 18 > SPIROMETER: on SPIRO CALIBRATION: 0 L/min AV-S v.2 Ventilator User Manual...

  • Page 39: Display Waveforms

    1. In Pressure vs. Time and Volume vs. Time modes the scale adjusts as Rate is changed (0 to 15 sec, 5 sec, 3 sec) 2. In Volume vs. Pressure mode the scale adjusts as Plimit is changed (-20 to 40, 60, 80 cmH2O). AV-S v.2 Ventilator User Manual...

  • Page 40: Alarms

    Printer not available Printer disconnected, or has no power, or has no paper. zero Automatic Priority level: High priority: Five ascending tones - repeated. Medium priority: Three ascending tones - repeated. Low priority: Single tone AV-S v.2 Ventilator User Manual...

  • Page 41: Oxygen Monitor

    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. AV-S v.2 Ventilator User Manual...
  • Page 42 SPIROMETER: on Low Alarm range 18% - 99% SPIRO CALIBRATION: 0 L/min 3. The displayed figure will flash on and off. 4. Press to confirm. 5. Scroll to EXIT MENUS, press the wheel to exit. AV-S v.2 Ventilator User Manual...

  • Page 43: Display

    1. Until the mute time is over, or the alarm condition has To cancel this alarm, check the sensor connection or replace been rectified. the sensor. The alarm can be muted for 120 seconds 2. When oxygen concentration drops below 18%. AV-S v.2 Ventilator User Manual...

  • Page 44: Specification

    Range: 0 - 50 L High Minute Volume Calculated value exceeds 150% of volume set. Range: 1 - 75 L Low and High O2 Concentration 18% - 105% High Airway Pressure 10 - 80 cmH2O adjustable AV-S v.2 Ventilator User Manual...

  • Page 45: Ventilator

    NOTE The ventilator is designed for use with Spirometry ON. Accuracy with Spirometry OFF may vary from the figures given above High airway pressure limit ±5 cmH2O Rate (bpm) ±10% Sigh Tidal volume + (50±5%) AV-S v.2 Ventilator User Manual...
  • Page 46 Volume Tests Not applicable 4.13 Mobility and Mounting (a) Mobility Secure mounting required (b) Mounting Control unit and remote screen are mounted on the anaesthetic machine. The bellows assembly is built into the A200SP Absorber. AV-S v.2 Ventilator User Manual...
  • Page 47 Air Pressure 50 – 106 kPa Electro-magnetic compatibility: The AV-S meets the requirements of BS EN 60601-1-2. Medical electrical equipment. General requirements for safety. Collateral standard. Electromagnetic compatibility. Requirements and tests MRI compatibility: The AV-S standard model is not suitable for use in an MRI environment 4.15...

  • Page 48: Oxygen Monitor

    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. AV-S v.2 Ventilator User Manual...

  • Page 49: Pre-Operation Procedures

    For AV-S used with a non-A200SP Absorber, refer to the Supplement at the back of this manual. WARNINGS Before the AV-S ventilator is used clinically for the first time a Calibration Check and Output Check must be successfully completed. This work must be carried out by a Penlon-trained technician, following the procedure in section 6.6 in the AV-S...

  • Page 50: Ventilator Gas Supply

    2. Connect the drive gas inlet port (1) on the rear of the control unit to a dry, oil free supply. WARNING AV-S control unit mounted on Prima 400 Series: Check that the hose is not obstructed by adjacent gas cylinders.

  • Page 51: Breathing System Schematic

    Pre-operation Procedures 5.1.4 Breathing System Schematic AV-S (with remote screen) and integral A200SP Absorber NOTE 1. AV-S has spirometry and oxygen monitor 2. Interface cabling is shown for connection to Prima series machine On/Off switch and A200SP Bag/Vent switch. 3. For AV-S used...
  • Page 52 IEC 60601-1 (Medical Systems). Interface and Parameter Inputs 5. A200SP Absorber bag/vent switch interface, and spirometer connector 6. Prima series system interface connector - (primary on/off switch) 7. Pressure monitor port 8. Input socket - oxygen monitor sensor AV-S v.2 Ventilator User Manual...

  • Page 53: Anaesthetic Gas Scavenging System

    DRIVE GAS) and the inlet port (2) at the rear of the A200SP absorber. WARNING AV-S control unit mounted on Prima 400 Series: Check that the hose is not obstructed by adjacent gas cylinders. Use the strap (3) fitted to the Prima 400 to hold the hose close to the machine frame.

  • Page 54: Remote Screen

    5. Close the system APL valve. 5.1.10 Prima 400 Series Interface Fit the interface cable. The interface cable (1) links the socket on the rear panel of the ventilator control unit (2) and the anaesthetic machine (3). AV-S v.2 Ventilator User Manual...
  • Page 55 - see MENU function, section 3.5. If the spirometer is switched OFF: a) Fresh gas compensation is disabled b) Fresh gas mixture compensation is disabled. c) Patient support function is disabled. AV-S v.2 Ventilator User Manual...
  • Page 56 This will also turn the AV-S off. Disconnect the fresh gas hose from the CGO block on the anaesthetic machine. 2. Turn the AV-S on at the ventilator switch (1) (do not use the gas delivery switch). 3. Remove the breathing circuit hoses from the inspiratory and expiratory connectors (2) on the absorber.

  • Page 57: Pressure Monitor Connections

    2. 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 cmH2O. AV-S v.2 Ventilator User Manual...

  • Page 58: Leak Test / Compliance Value Calculation

    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 the anaesthetic machine gas delivery switch). 4. Press the menu switch (3).
  • Page 59 A200SP Absorber. For additional information, please refer to the user manual for that product. For AV-S used with a non-A200SP Absorber, refer to the Supplement at the back of this manual. 5.1.14 Bellows Assemblies Fitting a Paediatric Bellows Assembly 1.

  • Page 60: Start-Up Default Settings

    The options will remain, even after the ventilator is turned off. Site Default Settings Adjust the parameter values from within the Service menu (SITE DEFAULTS). Press to confirm the new settings for site defaults. AV-S v.2 Ventilator User Manual...

  • Page 61: Pre-Use Checklists

    Pre-operation Procedures Pre-use Checklist For AV-S used with a non-A200SP Absorber, refer to the Supplement at the back of this manual. 5.3.1 Daily Checklist The following tests must be carried out at the beginning of every working day: 5.3.1.1 Hose and Cable Connections Check for correct connections: 1.

  • Page 62: Weekly Checklist

    2. Set the bag/vent switch (1) on the absorber to ‘Bag’. 3. Set a flow of 5 L/min on the anaesthetic machine. 4. Use the breathing bag on the absorber to deliver a flow. 5. Check that fresh gas flows from the inspiratory port (2). AV-S v.2 Ventilator User Manual...

  • Page 63: Oxygen Monitor Set-Up

    Pre-operation Procedures: Oxygen Monitor Oxygen Monitor System Set-up For AV-S used with a non-A200SP Absorber, refer to the Supplement at the back of this manual. 5.4.1 Installation Fit the probe (1) to the A200SP absorber. Connect the cable to the input socket (2) on the back of the...
  • Page 64 Allow the oxygen sensor to stabilise for 15 minutes (check that the reading (4) remains constant for a 30 seconds period). 6. Calibrate the sensor using the AV-S ventilator menu procedure, as follows. 7. Press the menu switch (5) and select the O2 MONITOR AND SPIROMETRY submenu.

  • Page 65: Sensor Low Indication

    Allow the oxygen sensor to stabilise (30 seconds minimum). 4. Scroll to ESCAPE FROM MENUS, press the wheel to exit. Check that the measured O2 concentration display (4) shows 100% (±1%). AV-S v.2 Ventilator User Manual...

  • Page 66: Maintenance

    Do not use strong organic acids, or compounds that release serviced by an engineer trained by the manufacturer, following oxygen or halogen. the schedule given below, and the procedures given in the AV-S Service Manual. Always keep a record of any service or 6.2.4 After cleaning repair work.
  • Page 67 (5) locates in the port in the patient block. 3. Fit the securing knobs (3). 6.2.8.6 Pre-use Checks 1. Function test the ventilator before clinical use (section 5.4). AV-S v.2 Ventilator User Manual...

  • Page 68: Sterilisation

    3. Screw the new sensor (2) into the absorber. 4. Attach the cable connector (1). 5. Calibrate the new sensor - see section 5.4.2. AV-S v.2 Ventilator User Manual...

  • Page 69: Appendix

    Optional extras and approved accessories Batteries in machines in normal use will be kept charged by WARNING the internal power supply. Only use accessories approved by Penlon Ltd. Note that the Low Battery Alarm indicator may be displayed if 57655 Compact pressure tee automatic recharging is taking place when the ventilator is in use.

  • Page 70: Menu System

    APNOEA ALARM LIMIT: 15 secs 15 - 180 (Integer) ALARM VOLUME: 100% 50 - 100% (Integer) BACK LIGHT LEVEL : 0 - 100% (Integer) Gas mixture: O2+Air O2+AIR O2+N2O Service Menu - see next page AV-S v.2 Ventilator User Manual...
  • Page 71 PEEP : OFF *The values listed for site defaults are examples LIMIT : 38 cmH2O **Sub-menus for Service PIN and Engineer Menu are not TRIGGER : 10 L/min accessible by users. APNOEA ALARM LIMIT : 15 sec AV-S v.2 Ventilator User Manual...

  • Page 72: Ventilator Spirometry System

    Appendix APPENDIX 5 Water Vapour Effects Water vapour in the breathing gas is not normally detectable. AV-S Ventilator Spirometry System Additional Features Ventilator Spirometry Measurement The user can turn off (1) compliance and fresh gas compensation, and The drive gas system and spirometry system uses a total of three (2) the feedback provided by the oxygen monitor.

  • Page 73: Symbols

    Do not dispose of in landfill, refer to an approved recycling facility. Follow your Fragile hospital, local, state and federal regulations. Alarm mute This way up Fuse General warning (yellow background) Menu AV-S v.2 Ventilator User Manual...

  • Page 74: References

    Appendix APPENDIX 7 References Standards The AV-S ventilator has been designed in accordance with the following Standards. EN ISO 80601-2-13: Medical electrical equipment. Particular requirements for basic safety and essential performance of an anaesthetic workstation. EN 60601-1: Medical electrical equipment - Part 1: General...

  • Page 75: Electromagnetic Compatibility (Emc)

    The AV-S ventilator should not be used adjacent to or stacked with other manufacturer’s equipment. If adjacent or stacked use is necessary, the AV-S ventilator should be observed to verify normal operation in the configuration in which it will be used.

  • Page 76: Compliance Level

    Guidance and manufacturer’s declaration - electromagnetic immunity The AV-S ventilator is intended for use in the electromagnetic environment specified below. The customer or user of the should assure that it is used in such an environment. Required test...
  • Page 77 70% UT (30% dip in UT) for 25/30 cycles 0% UT (100% dip in UT) for 250/300 cycles 0% UT (100% dip in UT) for 250/300 cycles Power frequency (50 Hz) 30 A/m 30 A/m Magnetic field IEC 61000-4-8 AV-S v.2 Ventilator User Manual...

  • Page 78: Av-S For Use With Non-A200Sp Absorber

    AV-S for use with non-A200SP Absorber (Penlon or non-Penlon absorber system) Mounting options The AV-S can be mounted on the anaesthetic machine as a single complete unit, as illustrated. Alternatively, the bellows unit (1) and control unit (2) can each be mounted separately in different locations.

  • Page 79: Function Test

    Supplement: AV-S for use with non-A200SP Absorber Pre-use Checklist 7. Check that spirometer readings, once settled, show correct delivery of 600 ±20 ml. S.4.1 Daily Checklist Tests to be carried out at the beginning of every working day: 8. Remove the breathing bag and occlude the patient ‘Y’...
  • Page 80 S.5.2.1 Oxygen Monitor Calibration - Using 100% Oxygen (AV-S used with a Penlon inboard absorber only) 1. Switch on the ventilator (1) and the anaesthetic machine gas delivery switch (2).
  • Page 81 Supplement: AV-S for use with non-A200SP Absorber S.5.2.2 Oxygen Monitor Secondary Point Calibration - Using Room Air (AV-S used with Penlon inboard absorber only) NOTE A primary calibration in 100% oxygen must be performed before this procedure. 1. Switch on the ventilator (1) and the anaesthetic machine gas control switch.
  • Page 82 Supplement: AV-S for use with non-A200SP Absorber User Maintenance S.6.1 Bellows and exhalation diaphragm valve Each time the bellows assemblies are opened for cleaning, all visible components must be carefully inspected. Damaged parts must be replaced. Bellows The bellows material must be inspected for aging at least every six months or after 1200 hours of use, whichever comes first.
  • Page 84 Like us at facebook.com/PenlonGlobal Follow us at twitter.com/PenlonGlobal 56529-en K © Penlon Ltd. 2021 All rights reserved. Penlon, InterMed and A200SP are trademarks of Penlon Limited. Part of the InterMed Group All other trademarks are the property of their respective owners.
  • Page 85 User Manual A200SP Absorber MRI A N A E S T H E S I A S O LU T I O N S 56548-en Rev. E (12 June.24)
  • Page 86 This page is blank...
  • Page 87 IMPORTANT Servicing and Repairs In order to ensure the full operational life of this device, servicing by a Penlon-trained engineer should be undertaken periodically. The absorber must be serviced to the schedule detailed in section 7.1. Details of these operations are given in the service manual for the A200SP Absorber MRI, available only for Penlon-trained engineers.
  • Page 88 Foreword This manual has been produced to provide authorised IMPORTANCE OF PATIENT MONITORING personnel with information on the function, routine, WARNING performance and maintenance checks applicable to the Anaesthesia systems have the capability to deliver mixtures A200SP Absorber MRI. of gases and vapours to the patient which could cause injury Information contained in this manual is correct at the date of or death unless controlled by a qualified anaesthetist.
  • Page 89 Bag/Ventilator Switch and Spirometer (AV-S) ........

  • Page 90: S4 Pre-Use Checklist

    Contents Pre-Use Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Pre-use Checklist .
  • Page 91 Should such a repair become necessary it is recommended that a request for service advice be made to Penlon Limited or the nearest Penlon Service Centre. This device and any of its constituent parts must be repaired...
  • Page 92 80601-2-55. 9. This device must not be altered or modified in any way c) A minute volume monitor. without the written approval of Penlon Limited. Before using the absorber d) A breathing system integrity alarm. 10. Breathing system connection: Do not use a patient Y-piece containing non-return valves.

  • Page 93: S6 User Maintenance

    Warnings and Cautions 22. Do not use any breathing hoses that have electrically conductive properties. 23. When touching the patient, do not touch any electrical device connector at the same time. 24. This device is not suitable for use in an oxygen-rich environment.

  • Page 94: Purpose

    This product is intended to be used for a patient population from neonatal to adult when used in conjunction with a Penlon-approved ventilator also designated for that patient population. Intended part of the body or type of tissue applied to or...

  • Page 95: Description

    3 . Description A200SP MRI Circle System Absorber 1. Adjustable pressure limiting valve (APL valve) 7. Ventilator bellows housing 2. Inspiratory non-return valve (NRV) 8. Expiratory hose connector 3. Inspiratory hose connector 9. Expiratory non-return valve (NRV) 4. Bag/ventilator switch 10.

  • Page 96: Canister

    Description 3 .1 Canister 3.1.1 Mounting The absorber must only be used when securely mounted in an upright position – spillage of absorbent may contaminate the breathing system – see WARNING, in section 5.1. 3.1.2 Gas Flow Direction Gas flows through the canister (1) from top to bottom. See also, section 3.11.

  • Page 97: Inspiratory And Expiratory Non-Return Valves (Nrv)

    Description 3.1.4 Absorbent Capacity The canister inner container (1) holds 1.3 kg (equivalent to 1500 ml) of loose absorbent. DO NOT OVERFILL - see section 5.3. Alternatively, a standard size pre-pack unit can be used in the canister (2) in place of the inner container (see section 5.3). Remove the inner container from the canister if a pre-pack unit is to be used.

  • Page 98: Adjustable Pressure Limiting (Apl) Valve

    Description 3 .4 Adjustable Pressure Limiting (APL) Valve The APL valve (1) is a spring loaded plastic float with a rubber seal, providing breathing system pressure control, and excess pressure relief. The spring pressure can be varied by rotating the control knob on top of the valve.

  • Page 99: Bypass System

    Interface to AV-S MRI Ventilator 3 .9 .1 Interface functions The absorber is designed to interface with the AV-S MRI ventilator control unit (1). The ventilator bellows unit (2) is built into the absorber. A cable links the multifunction connector (3) on the interface unit at the rear of the absorber to the connector (4) on the ventilator control unit.

  • Page 100: Oxygen Monitor Sensor

    1. The absorber is fitted with a pressure monitor self-sealing pressure outlet connector (1). 2. A tube links the outlet to the patient pressure inlet port (2) on the rear panel of the AV-S control unit. A200SP Circle Absorber MRI User Manual...

  • Page 101: Gas Flow

    6. Adjustable pressure limiting valve (APL) valve 7. Breathing bag 8. Patient 9. Expiratory non-return valve 10. Manometer 11. Pressure monitor sample line 12. Ventilator drive gas 13. Oxygen monitor sensor (AV-S ventilator) 14. Spirometer flow sensors A200SP Circle Absorber MRI User Manual...

  • Page 102: Specification

    4 . Specification NOTE Information in this section complies with the requirements of ISO 8835–2 and BS EN 80601-2-13. 4 .1 General Dimensions All figures are approximate Overall height: 380 mm Width: 186 mm Depth: 240 mm Weight (empty): 5.7 kg Mounting system: Polemount assembly 4 .2 Resistance of Breathing System...

  • Page 103: System Leakage Rate

    Specification 4 .4 System Leakage Rate Seal the patient connection port and the fully close the adjustable pressure limiting (APL) valve. These figures are measured with: 1. An absorber fitted with 1060 mm (42 inch) breathing hoses complying with ISO 5367, and a Safelock Y-piece. Absorber ‘ON’, canister in locked-on position.

  • Page 104: Device Classification And Labelling

    Specification 4 .8 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 IPX0 Ingress protection Classification according to the degree of protection against ingress of water: IPX0 (not protected) Sterilization The Absorber may be sterilized in an Autoclave.

  • Page 105: Installation And Operation

    3. Do not use any breathing hoses that have electrically conductive properties. AV-S ventilator Hoses and cables schematic showing the absorber connected to an AV-S ventilator control unit with remote screen - see next page. Nuffield 200 ventilator See section 5.2.1.
  • Page 106 Installation and Operation Breathing System Schematic 1. Bellows 17. Inlet - absorber - fresh gas supply 2. Ventilator 18. Drive gas inlet - ventilator 3. Outlets to anaesthetic gas scavenging system (AGSS) 19. Drive gas outlet - ventilator control unit to bellows 4.

  • Page 107: Breathing System

    3. AV-S Ventilator - Bellows drive gas hose Connect the bellows drive gas hose between the AV-S ventilator control unit drive gas outlet (4) and the connector (5) at the rear of the absorber.

  • Page 108: Oxygen Monitor

    5 .2 .6 Bag/Ventilator Switch and Spirometer (AV-S) The multifunction connector (14) provides an interface between the absorber and the AV-S ventilator: 1. The spirometer flow sensors, and 2. The sensor that detects the position of the Bag/Ventilator switch (12).

  • Page 109: Changing Co2 Absorbent

    Installation and Operation 5 .3 Changing CO2 Absorbent WARNING If the absorbent is to be changed during clinical use, adequate fresh gas flow must be maintained to prevent excessive build up of CO2. WARNING Anhydrous soda lime is known to react with some anaesthetic agents.

  • Page 110: Manometer

    Installation and Operation 5.3.3 Refilling with absorbent Recommended absorbent: See section 4.5.1. 5.3.3.1 Pre-packed soda lime 1. Check that the three spacers (7) are in place. 2. Check that the carrier (8) is in place. 3. Check the manufacturer’s instructions included with the pre-pack.

  • Page 111: Pre-Use Checks

    Read this user manual before using this absorber. If the system fails a test, do not use the absorber. The absorber must be checked by a Penlon-trained engineer. 1. Check the absorbent, replace if necessary. Before refitting the canister, check that the sealing surfaces are clean and dust free.

  • Page 112: Leak Test

    Pre-Use Checks The procedures detailed in sections 6.2 to 6.6 must be carried out in the order listed. The absorber must be attached to an anaesthetic machine, which must be leak tested before the checks are carried out. Check that the manometer is zeroed before use. 6 .2 Leak Test Check that the canister (1) is securely fitted, with the lever...

  • Page 113: Inspiratory And Expiratory Non-Return Valve Test

    Pre-Use Checks 6 .4 Inspiratory and Expiratory Non-return Valve Test 1. Detach the hose connecting the inspiratory (1) and expiratory (2) connectors. 2. Check that the adjustable pressure limiting (APL) valve (3) is closed. 3. Block the inspiratory valve outlet (1) with a suitable bung, and inflate the reservoir bag (not shown) with a 2 L/min oxygen flow.

  • Page 114: Leak Test - Absorber Canister Detached

    Pre-Use Checks 6 .6 Leak Test - Absorber Canister Detached 1. Turn the lever (1) clockwise to release the canister (2). 2. Set the switch (3) to Bag position and close the adjustable pressure limiting (APL) valve (4). 3. Pressurise the system to 3 kPa (30 cmH2O). Turn off the gas flow.

  • Page 115: Maintenance

    Do not fit a substitute absorber. c) Do not fit an absorber with a heater unit to a MRI anaesthesia system. 3. Servicing and repairs must only be carried out by Penlon- trained engineers. Service Schedule 1. Six-monthly inspection and function testing.

  • Page 116: Condensate Drainage

    Maintenance 7 .3 Condensate Drainage These operations must be carried out by suitably trained technicians only. WARNING Condensation, which may collect in the bottom of the absorber canister is caustic and care must be taken not to spill it on the skin when draining.

  • Page 117: Manometer

    Maintenance 7 .4 Manometer Remove the manometer (1) before sterilisation or disinfection. Grip the manometer and carefully detach from the absorber. CAUTION Do not sterilise the manometer. 7 .5 Adjustable Pressure Limiting APL) Valve Autoclave the APL valve (2) as part of the absorber assembly (see section 8.5.1).

  • Page 118: Sterilisation

    8 . Sterilisation 8 .1 Sterilisation Policy The operations detailed in section 8 must be carried out by suitably trained technicians only. Follow your local hospital guidelines. Autoclavable components are listed in section 8.5. 8 .2 Bacterial Filters The use of respiratory bacterial filters is essential to protect the oxygen sensor mounted at the side of the absorber.

  • Page 119: Absorber Assembly - Procedure Before Sterilisation

    Sterilisation 8 .4 Absorber Assembly - Procedure Before Sterilisation CAUTION Removal and refitting must only be carried out by qualified service personnel. When the absorber is lifted or carried by hand, always support the weight of the unit under the base. Do not lift the absorber by gripping any of the components attached to the manifold block.
  • Page 120 Sterilisation 8.4.3 Interface, Cables, Tubing 1. Disconnect all cable connectors and hoses, then remove the electrical interface unit (1). WARNING Do NOT immerse or autoclave the interface unit (1). 8.4.4 Bellows Assembly - Removal and Cleaning 1. Turn the bellows housing (1) anti-clockwise, then lift it from the base.
  • Page 121 Sterilisation 8.4.5 Dismantling and Cleaning the Absorber before Sterilisation CAUTION Removal and refitting must only be carried out by qualified service personnel. Always support the weight of the unit under the base. Do not lift the absorber by gripping any of the components attached to the manifold block (1).

  • Page 122: Sterilisation And Disinfectant Treatment Table

    Sterilisation 8 .5 Sterilisation and Disinfectant Treatment Table NOTE 1. After chemical disinfection, always rinse with warm water and dry in air. 2. Do NOT clean any component in an automatic cleaning/washing machine. 3. Before clinical use, ALWAYS carry out the Pre-use Checks listed in section 6 of this manual. 8 .5 .1 Absorber Component...

  • Page 123: Absorber Reassembly After Cleaning And Sterilisation

    Sterilisation 8 .6 Absorber Reassembly after Cleaning and Sterilisation CAUTION When the absorber is lifted or carried by hand, always support the weight of the unit under the base. Do not lift the absorber by gripping any of the components attached to the manifold block - see section 5.1.

  • Page 124: Appendix

    When ordering accessories, maintenance kits or spares, always state that the unit is used in a MRI environment UK Sales Tel: 01235 547036 Fax: 01235 547023 E-mail: uk.sales@penlon.com International Sales Tel: +44 1235 547001 Fax: +44 1235 547021 E-mail: international.sales@penlon.com...
  • Page 125 APPENDIX APPENDIX 3 Labelling MR conditional Type B applied part Refer to the user manual Do not dispose of in landfill, refer to an approved recycling facility. Follow your hospital, local, state and federal regulations. Bag (bag/ventilator switch) Ventilator (bag/ventilator switch) Gas inlet Lift Mechanism General Warning...
  • Page 126 APPENDIX APPENDIX 4 - Standards The A200SP MRI Absorber has been designed in accordance with the following standards: Standard Title Medical electrical equipment - general requirements for BS EN 60601-1 safety Medical electrical equipment - electromagnetic BS EN 60601-1-2 compatibility Inhalation anaesthetisia system part 2: Anaesthesia EN ISO 8835-2 Breathing systems...
  • Page 127 The user of the absorber should assure that it is used in an electromagnetic environment as described below. Changes or modifications to this anaesthetic machine system, not expressly approved by Penlon Limited, could result in EMC issues with this absorber. Contact Penlon Limited for more information.

  • Page 128: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    APPENDIX Guidance and manufacturer’s declaration - electromagnetic immunity The A200SP MRI Absorber is intended for use in the electromagnetic environment specified below. The customer or user of the absorber should assure that it is used in such an environment. Required test 60601 test levels for equipment used Compliance level in a professional healthcare facility...
  • Page 130 56548-en Rev. E (12 June.24) Follow us on Twitter A Medcaptain Company © Penlon Ltd. 2024 All rights reserved. Penlon and A200SP are trademarks of Penlon Limited. All other trademarks are the property of their respective owners. Penlon Limited International Sales...