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Airon pNeuton A, Operator'S Manual

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Airon pNeuton A Operator'S Manual Download Page 13

 

pNeuton Ventilator 

2 - 7   

Airon’s Medical Symbol Key

 

 

 

Consult Instructions of Use 

 

CE Marked 

 

Authorized Representative in European 
Community 

 

Model (Part) Number 

 

Lot Number 

 

Do Not Reuse 

MRI Conditional (3 T) 

 

Manufacturer 

 

Manufactured Date 

 

Use By Date 

 

Keep Dry 

 

  

 

Caution, serious injury or device 
damage may occur by disregarding the 
instructions accompanying this warning 
symbol. 

 

Summary of Contents for pNeuton A

Page 1: ...pNeuton Transport Ventilator Model A Operators Manual 97011 CD A 005 Rev J Released 1 Feb 2019...

Page 2: ...pNeuton is a Registered Trademark of the Airon Corporation Copyright 2011 by Airon Corporation Manufactured by Airon Corporation 751 North Drive Unit 6 Melbourne Florida 32934 USA Tel 888 448 1238 to...

Page 3: ...tient Safety Systems 3 6 Section 4 Operating Instructions 4 1 Ventilator Set up 4 1 Operational Verification 4 2 Patient Ventilation 4 3 Interrelationship of Volume and Rate Controls 4 4 Oxygen Contro...

Page 4: ...leshooting 8 1 Section 9 Cleaning and Maintenance 9 1 Cleaning the Ventilator 9 1 Cleaning Disinfecting the Patient Circuit 9 1 Routine Maintenance 9 1 Factory Preventive Maintenance 9 1 Section 10 Sp...

Page 5: ...nt The patient is allowed to breath spontaneously between the mandatory breaths with minimal work of breathing A built in PEEP CPAP system can be set to provide expiratory positive pressure The delive...

Page 6: ...pNeuton Ventilator 1 2...

Page 7: ...emphasis on an operating characteristic Warnings This manual serves as a reference The instructions in this manual are not intended to supersede the physician s instructions regarding the use of the p...

Page 8: ...priately Due to the design of the ventilator see Section 7 Theory of Operation the Tidal Volume and Respiratory Rate controls are interdependent The Tidal Volume control is a calibrated control The Re...

Page 9: ...available or until supply pressure returns to normal The alarm will only activate for a very short period of time if the gas supply abruptly ceases as can happen if the supply gas becomes disconnected...

Page 10: ...e an external spirometer to verify tidal volume accuracy The pNeuton Ventilator is MRI Conditional Non clinical testing demonstrated that the pNeuton Ventilator is MR Conditional and can be used in th...

Page 11: ...cause allergic reactions Special note on the presence of di 2 ethylhexyl phthalate DEHP The components devices accessories and packaging that make up the pNeuton Ventilator system do not contain any p...

Page 12: ...ation with or without PEEP CPAP with oxygen or a mixture of air and oxygen The ventilator is suitable for use in Pre hospital transport applications including accident scene emergency rescue vehicles...

Page 13: ...rked Authorized Representative in European Community Model Part Number Lot Number Do Not Reuse MRI Conditional 3 T Manufacturer Manufactured Date Use By Date Keep Dry Caution serious injury or device...

Page 14: ...pNeuton Ventilator 2 8...

Page 15: ...pNeuton Ventilator 3 1 Section 3 Controls and Patient Safety Systems Front Panel Pressure gauge patient circuit pressure Peak Pressure control of mandatory breaths calibrated range 15 to 75 cm H2O...

Page 16: ...control calibrated range 360 to 1 500 ml Respiratory Rate control calibrated range 3 to 28 bpm dependent on tidal volume setting Alarm visual indicator Alarm Reset Silence 1 minute Mandatory Breath c...

Page 17: ...pNeuton Ventilator 3 3 Patient Circuit connection see Section 5 for a complete description of the patient circuit and it s attachment to the front panel Expiratory Valve connection Rear Panel...

Page 18: ...pNeuton Ventilator 3 4 Driving Gas Input oxygen DISS connection requires 55 15 psi 380 100 kPa 40 liter minute minimum Alarm Low Driving Gas Ambient Air Inlet Filter Remote Alarm output...

Page 19: ...in text and machine readable format The numbers in the parentheses indicate different parts of the UDI as applicable to the device 01 Device Identifier 10 Batch Lot Number 11 Manufacturing Production...

Page 20: ...in the event of ventilator malfunction At approximately 2 cm H2O negative pressure an internal valve will open allowing unimpeded ambient air to enter the patient circuit for the patient This system i...

Page 21: ...the following conditions occur With Mandatory Breaths ON if a circuit pressure of at least 15 cm H2O is not sensed within 22 seconds after the last breath With Mandatory Breaths OFF if the circuit pre...

Page 22: ...pNeuton Ventilator 3 8...

Page 23: ...the test lung to the patient side of the breathing circuit 3 Set the controls as follows a Mandatory Breath control to On b Oxygen to 65 c PEEP CPAP to Off d Peak Pressure to 50 cm H2O e Tidal volume...

Page 24: ...ve the occlusion and allow the breathing circuit to remain open Using a stopwatch measure the time until the alarm sounds 22 3 seconds Pass Fail If the ventilator has passed all the above steps it is...

Page 25: ...ust the Respiratory Rate control to achieve the desired mandatory breath frequency 5 Adjust the Peak Pressure control to the desired level by turning the control while occluding the patient circuit an...

Page 26: ...is changed See Section 7 for a detailed description of the ventilator s Theory of Operation The Respiratory Rate control is calibrated for tidal volumes between 500 to 900 ml This allows the rate con...

Page 27: ...ensate for the effect of changing altitude on tidal volume and respiratory rate use an external spirometer to verify tidal volume accuracy Adjust the Tidal Volume and Respiratory Rate controls to the...

Page 28: ...cm H2O or turn on the mandatory breaths The alarm system can be momentarily silenced by pressing the Reset Silence button on the front panel Pressing this button turns off the visual and audible indic...

Page 29: ...e circuits will have part numbers from 58001 to 58999 Part Number Description 58001 6 ft 1 8 m disposable box of 15 58006 6 ft 1 8 m disposable with expiratory filter box of 15 58011 6 ft 1 8 m dispos...

Page 30: ...d full face mask for proper device operation Ventilator Connection The patient circuit must be attached to the ventilator properly Incorrect attachment could result in failure to provide adequate vent...

Page 31: ...ces may present serious incidents relating to the health and safety of patients and healthcare professionals Reuse can be unsafe because of risk of Cross infection inability to clean and decontaminate...

Page 32: ...pNeuton Ventilator 5 4...

Page 33: ...ent use Approved for use in line and on expiratory valve MRI compatible Mobile Stand 3 foot 9 inch 1 2 m tall MRI compatible stand designed to hold the pNeuton ventilator model S or A Two E size cylin...

Page 34: ...ironics Model 1118941 Allows the user to attach a remote alarm to the pNeuton Ventilator Great for the MRI control room Remote Alarm Cables MRI compatible BNC cables to attach the remote alarm to the...

Page 35: ...mpatible 3 foot green flexible hose 8 foot green flexible hose 12 foot green flexible hose 30 foot green flexible hose Note ISO color hose available Reusable Patient Circuit Adult pediatric patient ci...

Page 36: ...pNeuton Ventilator 6 4...

Page 37: ...and tidal volume breaths are delivered to the patient between which the patient may breathe spontaneously This section describes how the ventilator operates Further information on the ventilator s th...

Page 38: ...ines whether flow goes directly to the patient or through the high flow venturi If gas is directed to the patient a restrictive orifice limits the flow to a specific flow rate 36 L min If gas is direc...

Page 39: ...e will be caused by compression of gas based upon the compliance of the patient circuit used The compression volume of the ventilator itself is negligible With the Airon Corporation disposable patient...

Page 40: ...time changes to 2 sec Resultant Respiratory Rate is now 10 total time for inspiration and expiration 6 sec Tidal volumes below 500 ml will result in faster rates than marked on the Respiratory Rate co...

Page 41: ...to the desired inspiratory time and the Peak Pressure control to the desired peak pressure During pressure limited ventilation any excess flow will be released by the expiratory valve while maintaini...

Page 42: ...P control is calibrated to the dynamics of Airon Corporation disposable patient circuit Using this circuit will insure proper operation and the full 0 to 20 cm H2O PEEP CPAP range Oxygen Delivery Syst...

Page 43: ...ng of the CPAP venturi system at higher CPAP levels The actual FIO2 of spontaneous breaths will be approximately the same as the baseline flow Whether set for 65 or 100 extremely high inspiratory flow...

Page 44: ...r 660 liters PEEP CPAP off Minute Volume 100 Oxygen 65 Oxygen 5 l m 77 min 80 min 10 l m 40 min 76 min 15 l m 33 min 60 min The PEEP CPAP system when turned on uses approximately 5 L min oxygen from t...

Page 45: ...la Spatial field gradient 720 G cm The scanner used for testing was an active shielded system The ventilator was placed in the position of maximum field strength and maximum spatial gradient The stand...

Page 46: ...Pressing this button turns off the visual and audible indicators for 1 minute Each time the Reset Silence button is pressed the alarm system restarts the 1 minute silence time delay This delay is NOT...

Page 47: ...egulators will start to decrease pressure to the ventilator during mandatory breaths As this happens that Low Gas Supply Alarm will sense the decreased pressure and begin to intermittently alarm each...

Page 48: ...pNeuton Ventilator 7 12 power the ventilator s alarm When using the ventilator on a patient always insure that the supply gas is secure and operating at the proper pressure...

Page 49: ...service Ventilator seems to want to operate but no breaths are generated Peak Pressure control set too low Increase Peak Pressure control Respiratory Rate set too low Increase Respiratory Rate Expirat...

Page 50: ...libration Use external spirometer to verify tidal volume Tidal volume control out of calibration Send ventilator for service Internal malfunction Send ventilator for service Tidal volume inaccurate Le...

Page 51: ...ecommended by Airon Replace patient circuit Internal malfunction Send ventilator for service Excessive chattering of CPAP system Occurs when using some test lungs but will not when connected to a pati...

Page 52: ...andatory breath Tank may be low Check gas source 55 psi 380 kPa at 40 L min is required Mandatory Breaths OFF and CPAP set to less than 5 cm H2O Set CPAP to at least 5 cm H2O or Mandatory Breaths ON E...

Page 53: ...used See Single Use only Medical Device information page 5 3 Routine Maintenance Airon Corporation recommends that an Operational Verification Test see Section 4 be performed at initial installation a...

Page 54: ...pNeuton Ventilator 9 2 This service must only be performed by Airon Corporation or its approved service technicians Failure to perform this service may result in malfunctioning of the ventilator...

Page 55: ...on Ventilator System Performance Controls o Mandatory Breaths On or Off o Respiratory Rate from 3 to 50 bpm o Tidal Volume from 360 to 1 500 ml o Peak Pressure from 15 to 75 cm H2O o PEEP CPAP from 0...

Page 56: ...dal Volume 5 o Peak Pressure 5 o PEEP CPAP 5 o FIO2 5 Internal Compliance 0 1 ml cm H2O Ventilator Resistance to Flow o Inspiratory 60 L min less then 2 cm H2O l sec o Expiratory 50 L min less then 2...

Page 57: ...ercent humidity noncondensing Operating Temperature Range 5 to 40 C 23 to 104 F 15 to 95 percent humidity noncondensing Power Sources Driving gas requirement o 55 psi 15 psi 380 kPa 100 kPa o 100 oxyg...

Page 58: ...pNeuton Ventilator 10 4...

Page 59: ...ce during the warranty period If so instructed by the Distributor such defective products must be returned to the official AIRON CORPORATION Distributor in the original container with freight charges...

Page 60: ...ties THE PARTIES AGREE THAT THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND ALL OTHER WARRANTIES EXPRESS OR IMPLIED ARE EXCLUDED FROM THIS AGREEMENT Except as stated...

Page 61: ...n 2 4 4 5 Anti Suffocation System 3 6 C Cautions 2 3 Circuit Patient Breathing Cleaning 9 1 Configuration 5 1 Connecting 5 2 Cleaning Patient Breathing Circuit 9 1 Ventilator 9 1 Contraindications 2 6...

Page 62: ...terrelationship Between Volume Rate Controls 4 4 7 3 L Low Gas Supply Alarm 3 6 7 11 M Maintenance Ventilator Service 9 1 Mandatory Breaths FIO2 4 5 Flow Rate 6 3 Interrelationship Between Volume Rate...

Page 63: ...m 7 2 Pneumatic Low Gas Supply Alarm 3 6 Power Requirements Driving Gas Supply 10 3 Pressure Peak Pressure Control 3 1 PEEP CPAP Control 3 2 Pressure Gauge 3 1 Preventative Maintenance 9 1 Principles...

Page 64: ...Performance 10 1 Spontaneous Breaths FIO2 7 7 T Tidal Volume Control 3 2 Interrelationship Between Volume Rate Controls 7 3 Theory of Operation CPAP Demand Flow Breathing System 7 5 Mandatory Breath...

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