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Summary of Contents for Penlon AV-S MRI
- Page 1 User Manual AV-S Ventilator MRI AV-S Ventilator MRI A N A E S T H E S I A S O LU T I O N S IFU 56547-en L, 2022...
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Page 3: Servicing And Repairs
2. 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 MRI ventilator, available only for engineers trained by the manufacturer. For any enquiry regarding the servicing or repair of this... - 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 MRI Anaesthesia Ventilator. Anaesthetic systems have the capability to deliver mixtures 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.
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Page 5: Table Of Contents
Contents Page No. USER RESPONSIBILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 . - Page 6 Contents Page No. 5 . PRE-OPERATION PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 5.1 Ventilator Set-up .
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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
30 cm (12 2. The AV-S MRI ventilator is validated for use with 1.5 inches) to any part of the AV-S MRI ventilator, including tesla and 3.0 tesla scanners in an MRI environment cables specified by the manufacturer. - Page 9 Internal electrical fault. use function test on the ventilator. e) Software error. 21. The AV-S MRI ventilator is not intended for use in 35. Note that if a ventilator error is detected, ‘Ventilator intensive care applications. Inoperative’ will be displayed on the display.
- Page 10 Special conditions apply when positioning a Prima 451 any unauthorised person. system equipped with an AV-S MRI ventilator. Refer to 40. Service and repair operations must only be carried out Appendix 5 in the user manual for the Prima 451.
- Page 11 Warnings and Cautions: Oxygen Monitor OXYGEN MONITOR NOTES Note that the sensor for the oxygen monitor is built into the 1. The O2 SENSOR FAULT alarm indicates that one of the A200SP MRI Absorber - for additional information, refer to following conditions has occurred.
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Page 12: Purpose
It is designed for use in closed-circuit anaesthesia. Environment The AV-S MRI Ventilator is suitable for use by a professional operator in a professional healthcare facility and must be continuously attended when in use. MRI compatibility: see section 4.14... -
Page 13: Description
3 . Description 3 .1 General Description • The AV-S MRI 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. -
Page 14: Ventilator Rear Panel
3. Outlet - exhaust valve - connect to scavenge system - see 5.1.6 Electrical Connection 4. Connect to the AV-S MRI power supply unit - see 5.1.4. Interface and Parameter Inputs 5. A200SP Absorber bag/vent switch interface, and spirometer connector 6. -
Page 15: Ventilation Cycle
Description 3 .2 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. - Page 16 Description Pneumatic Flow Diagram 3 to 7 bar 241 kPa (35 psi) 0 - 80 cmH 0 - 90 cmH 100 cmH AV-S Ventilator MRI User Manual...
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Page 17: Pneumatic System
Pneumatic System Refer to the pneumatic system diagram on the previous page. A) Gas inlet manifold block The AV-S MRI ventilator is designed to operate on a 310 - 689 kPa (45 -100 psi) supply. 1. Drive Gas Inlet Connector The gas source is connected internally to the DRIVE GAS SUPPLY fitting on the rear of the ventilator control unit. -
Page 18: Electrical System
Mains Supply The mains supply inlet (1) is designed for connection to the AV-S MRI power supply unit (2), mounted on the rear lower shelf of the Prima 451 anaesthetic machine. Note that the Prima 451 gas delivery switch (3) must be in the ‘On’... -
Page 19: User Interface
Description User Interface 3 .5 .1 Control Panel and Touchscreen Control Panel 1. On/Off control (1) Switch On: Short internal test sequence. Switch Off: Power down sequence with progress indicator: Turn the on/off control to OFF. The ventilator will power- down. -
Page 20: Measured Parameters
Description Parameter Display Identification 1. Active Mode Black text on Grey (see, for example, 1A) Note: in Standby Mode the last used mode is shown with an underline (see, for example, 1B) 2. Active Parameters Active parameters that can be set for use in the current mode are displayed as: White text on Blue 3. -
Page 21: On-Screen Menus
Description 3 .5 .2 On-Screen Menus To Access: Press the menu switch (1) on the front panel to access the following functions and parameters via drop-down menus: Main Menu: EXIT MENUS O2 MONITOR & SPIROMETRY LEAK TEST FRESH GAS COMPENSATION:ON MODES WAVEFORM ALARM SETTINGS... -
Page 22: Start-Up Screens
Description 3 .5 .3 Start-up Screens 1. Start-up <Adult Defaults< SITE DEFAULTS VT Set : 600 mL At start-up, the software version VIEW VM Set : 6.0 Litres is displayed. T+PS INT : 10 cmH2O ii. The introduction screen allows Set BPM : 10 ADULT DEFAULTS the user to select one of three... -
Page 23: Selecting Functions And Parameters
Description 3 .5 .4 Selecting Functions and Parameters Functions/parameters shown on screen can be activated as follows: 1. Touch the screen at the appropriate tab area, or 2. Rotate the navigator wheel and press it when the indicator arrow is on the required parameter tab Note that unless Site Defaults are selected (see above) parameters default to factory-set values for Adult or Paediatric patients when the ventilator is switched on from... -
Page 24: Operational Capability
Description 3 .6 Operational Capability Tidal Volume, Rate, and I:E ratio settings are all limited by a maximum inspiratory flow of 70 L/min, and a minimum flow of 2 L/min. I:E Ratio 1:0.3 1:6 1:4 Tidal volume (Vt) (litres) Rate (bpm) The ventilator is capable of operating at the volumes and rates below each I:E ratio curve. -
Page 25: Output Compensation Functions
Description 3 .7 Output Compensation Functions WARNING The ventilator 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: 1. -
Page 26: Compliance Compensation
Description 3.7.3 Compliance Compensation The ventilator will apply compliance compensation to account for compliance loss in the breathing system in cases where: 1. Fresh gas compensation is disabled, or 2. Spirometry is unavailable or disabled NOTE 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. -
Page 27: Interface With Other Anaesthesia System Components
Description 3 .8 Interface to other Anaesthetic System Components 3.8.1 A200SP MRI Absorber Interface Automatic mode-switching: Bag Vent Control The absorber is fitted with a sensor that detects the position of the absorber bag/vent control (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 ventilator. -
Page 28: Ventilation Modes
Description 3 .9 Ventilation Modes 3.9.1 Standby Mode 1. Allows parameters to be set. 2. Some patient alarms are active: • High airway pressure (at 80 cmH2O) • High/Low oxygen • Negative pressure • Incorrect Rate/Ratio • Continuous high pressure •... -
Page 29: Volume Mode
Description 3.9.2 Volume Mode The ventilator delivers a mandatory set volume of gas at preset, fixed breath intervals. The patient is making no respiratory effort. Gas Mixture O2 + Air WARNING Neonates: Do not use volume mode for neonates. Use ONLY pressure control ventilation (pressure mode) for mandatory ventilation of neonates. - Page 30 Description 3.9.2.4 Volume Mode Operating Functions 1. Inspiratory Pause function: 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. Select Inspiratory Pause: •...
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Page 31: Pressure Mode
Description 3 .9 .3 Pressure Mode 3.9.3.1 Parameters In pressure mode the ventilator delivers a variable flow of gas to achieve a set pressure at fixed breath intervals. The patient is making no respiratory effort. Pressure range 5 - 70 cmH2O Note that the pressure limit is 5 cmH2O, or 10%, above the set target pressure, whichever is greater. -
Page 32: Spontaneous Mode
Description 3 .9 .4 Spontaneous Mode 3.9.4.1 Parameters The ventilator monitors the following patient parameters: • Rate • I:E ratio • Pressure • Tidal volume In spontaneous mode the waveform displays are active, and inspiratory oxygen levels are measured 3.9.4.2 Spontaneous Mode Operating Functions 1. - Page 33 Description NOTE a) The occurrence of another alarm event will override this feature. b) The alarm mute 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.
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Page 34: Advanced Spontaneous Breathing Modes
Description 3.9.5 Advanced Spontaneous Breathing Modes 3.9.5.1 SIMV Synchronised Intermittent Mandatory Ventilation NOTE Check that SIMV is an enabled option on your ventilator before attempting selection. Pmax SIMV allows spontaneous breaths and a set mandatory breath, synchronised with the start of a patient breath Select SIMV on the main display SIMV will be displayed on the main screen. -
Page 35: Smmv (Synchronised Mandatory Minute Ventilation)
Description 3.9.5.2 SMMV Synchronised Mandatory Minute Ventilation NOTE Check that SMMV is an enabled option on your ventilator before attempting selection. Pmax 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 PEEP 0 cmH2O... -
Page 36: Psv (Pressure Supported Ventilation)
Description 3.9.5.3 PSV Pressure Supported Ventilation NOTE Check that PSV is an enabled option on your ventilator before attempting selection. PSV assists each spontaneous breath to achieve a preset pressure, thus reducing the effort required to breathe. Inspiratory flow (generated by the patient’s spontaneous breath) results in synchronised pressure support Select PSV on the main display PSV will be displayed on the main screen. -
Page 37: Peep (Positive End Expiratory Pressure)
Description 3.9.5.4 PEEP (Positive End Expiratory Pressure) The AV-S MRI 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
Description 3 .10 Spirometry Spirometry can be enabled or disabled via the on-screen menu system. NOTE If the spirometry system is turned OFF: 1. Fresh gas / fresh gas mixture compensation is disabled. 2. Special Modes are disabled. See Appendix 3 for a detailed description of the spirometry system. -
Page 39: Display Waveforms
Description 3 .11 Display Waveforms The default waveform is always Pressure vs. Time (cmH2O vs. seconds) Wave Freeze is available when ventilation is in progress. 1. Waveform Pause and Print • Waveform pause icon (1) is located to the left hand side of the waveform displays. -
Page 40: Alarms
Description 3 .12 Alarms User adjustable alarms: Use the menu systems to set the required limits. Press the menu switch on the front panel (see 3.5.2), and select ALARM SETTING, or touch the alarm area on screen (see 3.5.1) Alarm Priority Trigger Mute... -
Page 41: Oxygen Monitor
Description: Oxygen Monitor 3 .13 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. 3.13.1 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. -
Page 42: Menus
Description: Oxygen Monitor 3.13.3 Oxygen Monitor Menu Select: O2 MONITOR ‘on’ O2 Monitor & Spiro To access Calibration and Alarm Set functions, the monitor ESCAPE FROM MENU must first be set to ‘on’ in the sub menu (1). > O2 MONITOR: on Scroll to O2 MONITOR, rotate the wheel to ‘on’, press the CALIBRATION: 100% wheel to confirm. -
Page 43: Display
Description: Oxygen Monitor 3.13.4 Display High-set, low-set, and oxygen concentration percentage readings are displayed on screen. Touch the tab to activate the O2 menu. Oxygen Concentration (1) The display provides a direct readout of measured oxygen concentrations in the range 0 - 100%. Low Alarm Set (2) - limited within 18 - 99% The oxygen percentage, set by the user, at which the low alarm will be activated. -
Page 44: Alarms
4 . Specification 4 .1 Application Ventilation of adult, paediatric and neonatal patients for use in anaesthesia WARNING Use ONLY Pressure Control Ventilation (Pressure Mode) for mandatory ventilation of neonates. 4 .2 Internal Compliance Adult bellows 3 ml/cmH2O (nominal) Paediatric bellows 2 ml/cmH2O (nominal) 4 .3 Physical... - Page 45 Specification 4 .5 Functional Tidal Volume Range NOTE (a) Tidal volume range limit values are based on bellows volume, not displayed values of V SET. (b) Tidal volume (or Minute volume) values are limited by the operational limit values given in section 3.6.
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Page 46: Bacterial Filter
Specification 4 .6 Advanced Spontaneous Breathing Modes (SIMV, SMMV, PSV) Trigger (PEEP referenced) 0.7 to 4 L/min Trigger window (SIMV, SMMV) Set 60% of Expiratory Time Vt and Vm (SIMV, SMMV) As Volume Mode Inspiratory time (Ti) 0.3 to 5 seconds Support pressure (PSV only) 4 to 70 cmH2O Default settings... -
Page 47: Device Classification
11.5 - 110 kPa Electro-magnetic compatibility: The AV-S MRI 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: AV-S MRI used as part of a Prima 451 MRI system... -
Page 48: Oxygen Monitor
Specification 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 15 seconds (air to 100% O2) Operating Temperature: -20 to 50°C (-4 to 112°F) Storage Temperature:... -
Page 49: Pre-Operation Procedures
1. Carry out all installation and set-up procedures before the anaesthesia system is taken into the MRI facility. 2. Before the AV-S MRI ventilator is used clinically for the first time a Calibration Check and Output Check must be successfully completed. -
Page 50: Breathing System Schematic
Pre-operation Procedures Breathing System Schematic 1. Bellows 17. Inlet - absorber - fresh gas supply 2. Ventilator control unit 18. Drive gas inlet - ventilator 3. Outlets to anaesthetic gas scavenging system (AGSS) 19. Drive gas outlet - ventilator control unit to bellows 4. - Page 51 3. Outlet - exhaust valve - connect to scavenge system - see 5.1.6 Electrical Connection 4. Connect to the AV-S MRI power supply unit. Connect the machine power lead to a suitable mains supply socket. Check that the mains indicator light (a) is on.
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Page 52: Bellows Drive Gas Connection
Pre-operation Procedures 5.1.5 Bellows drive gas hose 1. Prima 451 with A200SP MRI absorber: Connect a 16 mm diameter corrugated hose between the ventilator control unit drive gas outlet (1 - labelled: DRIVE GAS) and the connector (2) at the rear of the absorber. 5.1.6 Anaesthetic Gas Scavenging System 1. -
Page 53: Pre-Operation Procedure
Pre-operation Procedure 5.1.8 Spirometer 5.1.8.1 Flow sensors 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. - Page 54 Delivery on/off switch. This will stop all gas flows (including the anti-hypoxic device basal flow). This will also turn the ventilator off. 2. Turn the AV-S MRI on at the ventilator on/off switch (1). Disconnect the fresh gas hose from the CGO block on the anaesthetic machine.
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Page 55: Pressure Monitor Connections
Pre-operation Procedures 5.1.9 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 (1) on the rear panel of the control unit: •... -
Page 56: Leak Test / Compliance Value Calculation
Turn the anaesthetic machine gas flow off at the gas delivery on/off switch (1). This will stop all gas flows (including oxygen basal flow). Then switch the AV-S MRI on (2) at the ventilator 4. Press the menu switch (3). Select LEAK TEST from the main menu. -
Page 57: Bellows Assembly - Adult And Paediatric
Pre-operation Procedures Note that the bellows assembly is built into the A200SP MRI Absorber. For additional information, please refer to the user manual for that product. 5.1.11 Bellows Assemblies Fitting a Paediatric Bellows Assembly 1. Remove the adult bellows housing (1) - twist carefully CAUTION counterclockwise until the bayonet tabs become free, then Always ensure correct fitment of bellows (see illustration... -
Page 58: Start-Up Default Settings
Pre-operation Procedures Function Site Default (range or option) Adult Default Paediatric Default Vt (mL) 20 - 1600 Vm (L/min) 0.5 - 50 T+PS INIT (cmH2O) 4 - 70 Set BPM 4 - 100 I : E 1:0.2 to 1:8 PEEP (cmH2O) Off;... -
Page 59: Pre-Use Checklists
Pre-operation Procedures 5 .3 Pre-use Checklist WARNING Gauss field strengths can vary within the MRI suite, and in extreme cases a high gauss field will prevent ventilation. Before each clinical procedure, always carry out a pre-use function test on the ventilator, see 5.3.1.3, below. 5.3.1 Daily Checklist The following tests must be carried out at the beginning of... -
Page 60: Weekly Checklist
Pre-operation Procedures 7. Check the delivered tidal volume indicated on the scale printed on the bellows housing. Allowing for typical compliance in this configuration and a basal flow, the value should be between 600 ml and 800 ml. If the delivered tidal volume is outside this range, refer the ventilator to an engineer trained by the manufacturer. -
Page 61: Oxygen Monitor Set-Up
Installation Fit the sensor (1) to the A200SP MRI absorber. Connect the cable to the input socket (2) on the back of the AV-S MRI ventilator. WARNING The sensor contains a small quantity of electrolyte, classified as a harmful irritant which is potentially hazardous. - Page 62 Pre-operation Procedures: Oxygen Monitor 5.4.2.1 Calibration - Using 100% Oxygen AV-S MRI ventilator mounted on a Prima 451 MRI anaesthetic machine fitted with a A200SP MRI absorber Calibrate with the sensor in position within the absorber. 1. Detach the absorbent canister (1) and remove the breathing circuit hoses from the inspiratory and expiratory connectors (2) on the absorber.
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Page 63: Sensor Low Indication
Pre-operation Procedures: Oxygen Monitor 16. Press the menu switch (5) and select the O2 MONITOR Check that the measured O2 concentration display (4) AND SPIROMETRY sub-menu. shows 100% (±1%). 5.4.3 Sensor Low Indication 17. Scroll to CALIBRATION and press the navigation wheel / button to select the calibration option. -
Page 64: Maintenance
The sensors are built into the A200SP MRI absorber. Cleaning AV-S MRI Service Manual. Always keep a record of any service and sterilisation can only be carried out when the absorber or repair work. - Page 65 CAUTION After cleaning and sterilisation, and/or repair, the patient block assembly must be refitted to the original AV-S MRI ventilator control unit (see NOTE 1 in 6 .2 .5 .2, below) . 6.2.5.2 Disassembly 1.
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Page 66: Sterilisation
Maintenance 6 .4 Oxygen Sensor Replacement 6 .3 Sterilisation These operations must be carried out by suitably trained These operations must be carried out by suitably trained technicians only . technicians only. CAUTION WARNING To prevent possible damage to components, peak The sensor contains: sterilisation temperatures must not exceed 134 C (275... -
Page 67: Appendix
Do not assume that individual components of 7 to 21°C (45 to 70°F) 6 months the AV-S MRI ventilator and Prima 451 MRI system (including any Penlon accessories), can be safely used 0 to 7°C (32 to 45°F) 9 months with MRI scanners when used on any other anaesthesia -5 to 0°C (23 to 32°F) -
Page 68: On-Screen Menus
Appendix APPENDIX 4 3. Use the touchscreen to access sub-menus: Alarm settings: Touch the alarm display area On-screen Menus Modes menu: Touch the mode icon area Gas mixture: Touch the gas mix display NOTE: Waveform menu: Touch the waveform display area 1. - Page 69 Appendix MODES MENU ESCAPE FROM MENU SUPPORT MODE: SIMV, SMMV, The MODES menu is context sensitive, with content dependent on current mode . VOLUME TYPE: Tidal In STANDBY the MODES menu is: SIGH ENABLE: ESCAPE FROM MENU SIGH TO BREATH RATIO: SUPPORT MODE: SIMV, SMMV, PSV INSP.
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Page 70: Ventilator Spirometry System
Appendix APPENDIX 5 Water Vapour Effects Water vapour in the breathing gas is not normally detectable. AV-S MRI 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 71: Appendix 6 . Symbols
Appendix Appendix 6 . Symbols MR Conditional (i.e. poses no known hazard in a specified MR environment, with specified Serial number conditions of use, and specific configurations - see section 4.14). This label has a yellow background. Max stacking weight Operating instructions (this user manual) Keep packaging dry Refer to user manual... -
Page 72: References
Appendix Appendix 7 . References Standards The AV-S MRI 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 requirements for basic safety and essential... -
Page 73: Electromagnetic Compatibility (Emc)
AV-S MRI ventilator Guidance and manufacturer’s declaration – electromagnetic emissions The AV-S MRI ventilator is intended for use in the electromagnetic environment specified below. The customer or user should assure that it is used in such an environment. -
Page 74: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
Appendix Guidance and manufacturer’s declaration - electromagnetic immunity The AV-S MRI 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 76 Follow us at twitter.com/PenlonGlobal IFU 56547-en L, 2022 A Medcaptain Company © Penlon Ltd, 2022. All rights reserved. Penlon, AV-S and A200SP are trademarks of Penlon Limited. All other trademarks are the property of their respective owners. Penlon Limited Technical Support International Sales UK Sales OBELIS S.A.
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