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pNeuton® - Airon Corporation

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1. 25 Peak Pressure control of mandatory breaths calibrated range 15 to 75 cm HO T5 cm H0 pNeuton Ventilator 3 1 PEEP CPAP 10 i C cm H 0 TIDAL VOLUME 1100 700 360 anh 1500 adjusts insp tira RESP RATE 6 42 18 2 3 8 b min at 500 te 900 mi Tidal Volume adjusts exp tima ALARM RESET SILENCE MANDATORY BREATHS On Off oe o OXYGEN 65 100 pNeuton Ventilator PEEP CPAP control calibrated range 0 to 20 cm H2O Tidal Volume control calibrated range 360 to 1 500 ml Respiratory Rate control calibrated range 3 to gt 28 bpm dependent on tidal volume setting Alarm visual indicator Alarm Reset Silence 1 minute Mandatory Breath control turns on or off mandatory breath system Oxygen control select either 100 or 65 PATIENT CONNECTION EXP VALVE Rear Panel p euton Transport Ventilator intended for use on pediatric and adult patients 23 kg and above Ci caution Reed and understand operating instructions prior ic use Federal lw USA restricts this devico to sale or uae on the order of a physician Driving Gas Input xo Oxygen 55 15 ps 380 100 kPa 40 Limin minimum pNeuton Ventilator 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 A Warning Do not use in the presanca of flarmabis
2. device failure from reprocessing or reuse because of fatigue or material alteration e Chemical burns or sensitization residues from chemical decontamination agents on materials that can absorb chemicals AN note If you reuse a single use device you may be legally liable for the safe performance of the device pNeuton Ventilator 9 3 pNeuton Ventilator Section 6 Accessories Using the pNeuton Ventilator should be convenient and user friendly for healthcare providers and patients Accessories for the device add serviceability in clinical situations and allow the device to adapt to the environment of use C Bacterial Viral Filter Disposable single patient use Approved for use in line and on expiratory valve Safe T Vent Nebulizer Designed to nebulize medications for inhalation in conjunction with the pNeuton Ventilator and other positive pressure breathing devices This unique nebulizer system includes a spring loaded seal that allows the nebulizer to be removed while maintaining positive pressure _ 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 cylinders can be securely mounted on the stand The ventilator attaches to the stand using a mounting plate which allows the user to _ Slide the ventilator on and off oNeuton Ventilator Adult pedia
3. As such the assessment of magnetic field interactions for this product specifically involved evaluations of translational attraction and function in relation to exposure to a 3 Tesla MR system only Airon recommends that users perform similar tests in their MRI scanner prior to patient use pNeuton Ventilator 2 4 Special note on the presence of latex The components devices accessories and packaging that make up the pNeuton Ventilator system do not contain any dry natural rubber or natural rubber latex which may 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 phthalates which are classified as carcinogenic mutagenic or toxic to reproduction of category 1 or 2 in accordance with Annex to Directive 67 548 EEC Additional Warnings Cautions and Notes are located throughout this manual pNeuton Ventilator 2 5 Indications for Use The pNeuton Ventilator is intended for continuous mechanical ventilation of patients in the following patient populations and use locations Patient population adult pediatric patients 23 Kg and greater who require the following general types of ventilatory support e positive pressure ventilation delivered invasively via an ET tube or non invasively via a mask e CMV and IMV modes of ventilation e with or without PEEP CP
4. H20 is required If CPAP is set for less than 5 cm H20 and Mandatory Breaths are not turned on the alarm system will activate The alarm system provides a passive non electrically charged remote alarm output on the rear of the ventilator pNeuton Ventilator 7 10 The remote output uses a normally closed signal output with a resistance of 51K Ohms When an alarm occurs the signal output opens to infinite resistance This is a passive remote alarm output that does not provide its own electrical signal Use the Airon Remote Alarm Part number 21031 to provide a remote audible and visual indication of active alarm conditions Low Gas Supply Alarm The Low Gas Supply Alarm will occur if the driving gas supply drops below safe levels 30 psi 200 kPa The alarm activates as long as driving gas is available or until the supply pressure returns to normal When operating from an oxygen cylinder the ventilator will gradually use up the gas in the cylinder and tank pressure will fall Once the cylinder pressure reaches approximately 500 psi most portable tank regulators 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 time the pressure drops during inspiration As pressure in the cylinder falls to lower values the amount of time the regulator is delivering low pressure increases and the alarm sound
5. allow the patient to breathe on his or her own 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 is always available to the patient irrespective of control settings including PEEP CPAP Low Gas Supply Pressure Alarm Whenever the driving gas supply pressure drops below the safe operating pressure the visual alarm indicator will illuminate and an internal pneumatic audible alarm will sound This low pressure alarm will occur when the source gas pressure drops below 30 psi 200 kPa The alarm will continue to sound until all pressure has been lost in the system or when pressure is re established to at least 35 psi 250 kPa JIN WARNING The Low Gas Supply 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 pNeuton Ventilator 3 5 disconnected Always insure that the supply gas is secure and operating at the proper pressure Disconnect Alarm The ventilator automatically monitors patient pressure at all times If there is a disconnection in the patient circuit the visual alarm indicator will illuminate and the audible alarm will sound The alarm activates when either of the following conditions occur e With Mandatory Breaths ON if a circuit pressure of at least 15 cm H20 is not sensed within 22 se
6. anesthoia A Note Tidal volume adjusts inpsiratory time Respiratory Rate adjusts expiratory time Respiratory Rate control is calibrated for tidal volumes from 500 to 200 mi Lower tidal volumes will have higher rates higer tidal volumes f will have lower ryer MAI Conditional up to 3 T statie fiedd strength 720 Giem spacial Taig gradient REMOTE ALARM O2 Made in tho USA by Airon Corporation r 791 North Grive Unit 6 Melbourne Florida LISA pHeuton Ventilator Model A Serial Number Driving Gas Input Oxygen 55 15 psi 380 100 kPa 40 L min minimum REMOTE ALARM pNeuton Ventilator ZN 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 Internal Patient Safety Systems The ventilator has several internal safety systems These systems insure patient safety in the event of ventilator malfunction High Pressure Release The patient circuit peak pressure is adjustable using the Peak Pressure control This control can be set from 15 to 75 cm H20 The factory preset value is 50 cm H20 In addition to this control there is an internal safety pressure release valve This valve will automatically limit circuit pressure to approximately 80 cm H2O regardless of the setting of the Peak Pressure control Anti Suffocation System An internal safety system will
7. expiratory time These valves charge or reduce pressure to a pneumatic timing cartridge This timing cartridge turns on or off the ventilator s main flow valve The main flow valve controls gas flow from the internal regulator to the Oxygen control which in turn delivers it to the patient The Oxygen control setting determines 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 directed to the high flow venturi ambient air is entrained to provide precisely the same flow to the patient but at a reduced F O2 approximately 65 The high flow venturi provides stable performance no stall up to the maximum operating pressure 75 cm H20 of the ventilator The pressure generated by the main flow valve also powers the Peak Pressure control system This system sends an adjustable pressure to the patient circuit expiratory valve The pressure in this system determines the peak pressure that can be generated in the patient circuit The adjustable PEEP CPAP system directs a pressure signal to the expiratory valve to generate PEEP and provides flow on demand for spontaneous breaths pNeuton Ventilator 7 2 Tidal Volume and Rate Control System pNeuton s Tidal Volume and Respiratory Rate controls function to determine mandatory breath inspiratory and expiratory time Since the ventilator pr
8. minute Use at higher Use external volume then altitude then spirometer to verify desired calibration tidal volume out of calibration service Internal malfunction Send ventilator for service Tidal volume Leak in the patient Check patient inaccurate ET Tube mask interface Replace breathing circuit or patient circuit if at expiratory valve fault Ventilator is Tidal volume should operating at an be measured by an altitude different external spirometer then calibration Tidal volume control Send ventilator for out of cal service Rate control Tidal volume set This is normal Rate inaccurate below 500 ml or will be faster when above 900 ml tidal volume is set lower than 500 ml Rate will be slower when tidal volume is set higher than 900 ml Ventilator stops Insufficient driving Check gas source and starts gas supply 99 psi 380 kPa at Rate control out of Send ventilator for 40 L min is required cal service pNeuton Ventilator 8 1 pNeuton Ventilator 8 2 Indication Meaning Corrective Action Ventilator does Missing or Check gas source not operate no insufficient driving 55 psi 380 kPa at patient ventilation gas supply 40 L min is required disconnection circuit service Ventilator seems Peak Pressure Increase Peak to want to control set too low Pressure control operate but no breaths are generated Respiratory Rate set Increase Respiratory too low Rate Expiratory valve Insure tubing is drive
9. must be removed from clinical use DO NOT return the unit to clinical use until all repairs has been completed by an Airon approved repair facility and all operational verification tests are acceptable J the pNeuton Ventilator has been designed for use on adult and pediatric patients The pNeuton cannot deliver operator adjusted tidal volumes less than 360 ml DO NOT use the pNeuton Ventilator on neonatal or infant patients or small children To protect the patient from high airway pressures insure that the Peak Pressure control is adjusted appropriately A 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 Respiratory Rate control is calibrated for a set tidal volume between 500 ml and 900 ml Lower tidal volumes will have higher rates higher tidal volume will have lower rates Once the tidal volume is set it will not vary as the respiratory rate is changed However if the Tidal Volume control setting is changed the respiratory rate may change Always recheck the patient s mandatory breath rate after changing the tidal volume to assure the patient is receiving the proper respiratory rate N the pNeuton Ventilator is not intended for use under hyperbaric pressure conditions If used in these conditions tidal volume delivery will significantly decrease Careful patient monitoring of tidal
10. required a lower tidal volume may be necessary Likewise if a high tidal volume is required a lower respiratory rate may be needed pNeuton Ventilator 4 4 Oxygen Control The ventilator uses internal venturi systems which provide the oxygen concentration delivered to the patient See Section 7 for a complete description of these systems It is recommended that an external oxygen analyzer always be used to verify oxygen delivery Hypobaric Operation The ventilator will operate normally at altitudes up to 15 000 feet Changes in altitude will not affect pressure settings However delivered tidal volume increases and respiratory rate decreases with increasing altitude This is due to lower barometric pressure than ventilator calibration at standard sea level To compensate 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 desired value as measured by the spirometer rather than the markings on the control panel Disconnect Alarm The ventilator has a patient circuit disconnect alarm system This system cannot be turned off If a circuit disconnect is sensed the visual indicator on the front panel will illuminate and the audible alarm will sound The alarm will activate as soon as an oxygen source is turned on to the ventilator You may silence the alarm for 1 minute by pressing the Res
11. silenced pNeuton Ventilator 10 Environmental and Physical Characteristics MRI Conditional Tested with a scanner up to o Maximum static field strength 3 T o Maximum spatial field gradient 720 G cm Hypobaric high altitude compatible up to 15 000 feet 4 600 meters Weight and Size 6 5 pounds 3 kg 5 0 H x 10 0 W x 7 3 D 12 7 cm x 25 4 cm x 18 5 cm Storage Temperature Range 20 to 60 C 4 to 140 F 15 to 95 percent 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 oxygen Do not use the ventilator with other types of gases o The gas supply must be capable of delivering at least 40 liters per minute at 55 psi If input pressure drops less than 30 psi due to insufficient gas flow the ventilator will alarm and begin to malfunction NOTE Driving gas consumption at 10 L min minute volume o PEEP CPAP off 4 L min o PEEP CPAP on 65 9 L min o PEEP CPAP on 100 15 L min pNeuton Ventilator 10 3 pNeuton Ventilator Section 11 Limited Warranty AIRON CORPORATION through its Official Distributor warrants this product to be free from defects in construction material and workmanship for a period of twelve 12 months from the date of original delivery to buyer when operated properly under conditions of normal use for which the product is i
12. volume with a hyperbaric compatible external spirometer is mandatory pNeuton Ventilator 2 2 3 T see Notes section below While tests show that the ventilator functions at the bore of the MRI unit Airon Corporation does not recommend that the ventilator be clinically used at or within the bore of MRI scanners A minimum proximity of 12 inches 0 3 meter from the bore should be used In addition safe MRI practice calls for all devices used in the proximity of a MRI scanner including pNeuton be anchored to prevent inadvertent movement The pNeuton Ventilator is MRI Conditional up to The Low Gas Supply Alarm will occur if the driving gas supply drops below safe levels 30 psi 200 kPa The alarm activates as long as driving gas is 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 Always insure that the supply gas is secure and operating at the proper pressure Cautions po NOT attempt to service the unit Service may only be performed by Airon Corporation authorized engineers The Preventative Maintenance program requires a general service and calibration every two years Only original manufacturer parts and accessories should be used Any attempts to modify the hardware of this device without the express written approval of Airon Corporation will void all warranties and l
13. AP e with oxygen or a mixture of air and oxygen The ventilator is suitable for use in e Pre hospital transport applications including accident scene emergency rescue vehicles e Hospital ICU transport applications including emergency radiology surgery post anesthesia recovery and MRI departments e Air transport via helicopter or fixed wing Contraindications The following conditions contraindicate the use of the pNeuton Ventilator e Patients undergoing procedures with flammable anesthetic gasses e Patients undergoing hyperbaric treatment e Infants and neonatal patients requiring tidal volumes less than 360 ml pNeuton Ventilator 2 6 Airon s Medical Symbol Key Consult Instructions of Use Authorized Representative in European a Community EC ENERGO REF Model Part Number Do Not Reuse A MRI Conditional 3 T Pe wl Manufactured Date Use By Date Caution serious injury or device damage may occur by disregarding the instructions accompanying this warning symbol pNeuton Ventilator 2 7 pNeuton Ventilator Section 3 Controls and Patient Safety Systems Front Panel PEEP CPAP PEAK PRESSURE RESET Yo MANDATORY ALARM SILENCE OXYGEN BREATHS 50 1 25 oO O 65 100 On ort om H O om H0 ACT Ts PATIENT CONNECTION TIDAL VOLUME RESP RATE pNeuton Pneumatic Transport Ventilator Pressure gauge patient circuit pressure o 80 cm Hz jmbarj PEAK PRESSURE 50
14. Hose DISS Female both ends g g MRI compatible 3 foot green flexible hose 8 foot green flexible hose 12 foot green flexible hose 30 foot green flexible hose 3 Note ISO color hose available Reusable Patient Circuit Adult pediatric patient circuit PATTI Mee autoclavable i eee 1 8 meters 6 ft Available for International Customers Only pNeuton Ventilator 6 3 pNeuton Ventilator Section 7 Theory of Operation pNeuton is a pneumatic ventilator based upon the Intermittent Mandatory Ventilation IMV principle As such adjustable respiratory rate 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 theory of operation including circuit diagrams parts lists and calibration instructions are available from Airon Corporation to properly trained service personnel Pneumatic System Diagram Gas Inlet Peak Press Gas Delivery Control Venturis pNeuton Ventilator 7 1 1 Pneumatic System Description The major components of the pneumatic system and the control of gas flow through the ventilator are as follows High pressure gas oxygen enters the ventilator and is filtered 5 micron and reduced to a lower working pressure 35 psi 240 kPa The timing circuit uses two precision control valves to control inspiratory and
15. Interrelationship Between Volume amp Rate Controls 4 4 7 3 L Low Gas Supply Alarm 3 5 7 11 M Maintenance Ventilator Service 9 1 Mandatory Breaths FO 4 5 Flow Rate 6 3 Interrelationship Between Volume amp Rate Controls 6 3 Medical Symbol Key 2 7 Mode of Operation 2 5 6 1 MRI Compatibility 7 9 10 2 N Notes 2 4 O Operational Verification 4 2 Oxygen Oxygen Control 3 2 Driving Gas Inlet 3 4 Driving Supply Requirements 10 3 Operational Characteristics 7 6 pNeuton Ventilator 12 2 Tank Expected Operating Time 7 7 p Patient Circuit Cleaning 9 1 Configuration 5 1 Connecting 5 2 Disconnect Alarm 3 6 4 5 Single Use 5 3 Patient Ventilation 4 3 Peak Pressure Control 3 1 Performance Verification 4 2 PEEP CPAP Control 3 2 Functional Operation 7 5 Trigger Sensitivity 7 6 Pneumatic System 7 2 Pneumatic Low Gas Supply Alarm 3 5 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 of Operation CPAP Demand Flow Breathing System 7 6 Mandatory Breath Pressure Control System 7 5 Oxygen Delivery System 7 6 Pneumatic System Diagram 7 1 Pneumatic System Description 7 2 Tidal Volume and Rate Control System 7 3 R Rear Panel 3 3 Respiratory Rate Control 3 2 Interrelationship Between Volume amp Rate Controls 4 4 7 3 pNeuton Ventilator 12 3 S Safety Systems 3 5 Sensitivity 7 6 Set Up 4 1 Service Pr
16. N CORPORATION is also excluded from this warranty The warranty described in this Agreement is in lieu of all other warranties 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 above AIRON CORPORATION SHALL NOT BE LIABLE FOR ANY DAMAGES CLAIMS OR LIABILITIES INCLUDING BUT NOT LIMITED TO PERSONAL BODILY INJURY OR INCIDENTAL CONSEQUENTIAL and OR SPECIAL DAMAGES pNeuton Ventilator 11 2 Section 12 Index A Accessories 6 1 Administering Oxygen 7 6 Airway Connection Port 3 3 Alarms High Pressure 3 5 Low Gas Supply 3 5 7 11 10 2 Patient Disconnect 3 6 4 5 7 10 10 2 Altitude Operation 2 4 4 5 Anti Suffocation System 3 5 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 Controls Oxygen 3 2 Peak Pressure 3 1 PEEP CPAP 3 2 Respiratory Rate 3 2 Tidal Volume 3 2 Continuous Flow CPAP 7 5 CPAP Control 3 1 Functional Operation 7 5 Trigger Sensitivity 7 6 E Expiratory Valve Connection 3 3 5 2 pNeuton Ventilator Relationship to PEEP CPAP System 7 6 F Front Panel 3 1 H High Altitude Operation 4 5 High Pressure Alarm 3 5 Hyperbaric Operation 2 2 Hypobaric Operation 4 5 Indications For Use 2 6 Internal Patient Safety Systems 3 5
17. Volume control and the Respiratory Rate control which must be considered while operating this ventilator The Tidal Volume control is a calibrated control and will not vary from its setting during normal operation It will not change if the Respiratory Rate control is changed The Respiratory Rate control is calibrated and will not vary the patient s mandatory breath rate unless changed However if the Tidal Volume control setting is changed the actual respiratory rate may change even if the Respiratory Rate control is not moved The ventilator operational characteristics define the reason the rate changes when the tidal volume 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 control to be preset with initial set up of the ventilator on a patient Always count the patient s mandatory breath rate when first setting up the ventilator and after any changes to the tidal volume to assure the patient is receiving the proper respiratory rate The mandatory breath inspiratory flow is fixed at 36 L min Due to this preset flow rate it is possible that desired combinations of high tidal volume and respiratory rates may not be available In other words combinations of high tidal volumes and high mandatory breath rates are limited by the fixed mandatory breath flow rate If a high respiratory rate is
18. attachment could result in failure to provide adequate ventilation PATIENT CONNECTION The main breathing hose 22 mm is connected to the Patient Connection port EXP VALVE The small tubing 3 mm connects the expiratory valve to the Expiratory Valve port NOTE The Airon patient circuit is a single use disposable device Cleaning reprocessing and or reuse of this device is not recommended The circuit and all components are sold clean and non sterile pNeuton Ventilator 5 2 Single Use only Medical Devices Accessories How do know if a device is Single Use This symbol will be identified on the packaging and User s Manual of the device What does Single Use mean Do not reuse A single use device is used on an individual patient during a procedure such as transport ventilation and then discarded It is not intended to be reprocessed and used again even on the same patient What is the concern with reused device labeled Single Use The use of reprocessed devices may present serious incidents relating to the health and safety of patients and healthcare professionals Reuse can be unsafe because of risk of e Cross infection inability to clean and decontaminate due to design device components are not manufactured for disassembly and reassembly e Endotoxin reaction excessive bacterial breakdown products which cannot be adequately removed by cleaning e Patient injury
19. compatible Testing in a MRI scanner has shown that the scanner does not affect the ventilators performance The ventilator does not generate artifact RF noise or other deleterious effects on the operation of the MRI scanner or it s production of an image In addition due to pNeuton Ventilator components heating of the ventilator does not occur during scanning Testing for MRI compatibility was done following ASTM MRI safety standards F2052 06e1 and F2119 07 The MRI scanner used has the following maximum performance levels e Static field strength 3 Tesla e 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 standard patient circuit Airon part number 58031 was used A standard imaging sequence with a maximum scanning time of 5 minutes was used The pNeuton Ventilator meets testing requirements for use within the Magnetic Resonance Environment with a conditional marking for safety NOTE Airon recommends that users perform the above referenced tests in their MRI scanner prior to patient use WARNING While tests show that the ventilator functions at the bore of the MRI unit Airon Corporation does not recommend that the ventilator be clinically used at or within the bore of MRI scanners A minimum proximity of 12 inches 0 3 meter from the bore should be pNeuton Ventilat
20. conds after the last breath e With Mandatory Breaths OFF if the circuit pressure is less than 5 cm H20 for 22 seconds NOTE Setting the CPAP level less than 5 cm H2O with mandatory breaths off will cause the alarm to sound continuously The Disconnect alarm may be silenced for 1 minute by pressing the alarm Reset Silence button NOTE Always use an external oxygen monitor to insure the desired oxygen percentage is delivered to the patient pNeuton Ventilator 3 6 Section 4 Operating Instructions Operational Verification Ventilator Set up Verification Step Acceptable Range The following equipment is needed Attach a spirometer to the 1 pNeuton Ventilator with breathing circuit see expiratory valve using the elbow Section 5 for a list of compatible circuits included in the circuit packaging 700 70 ml Pass Fail 2 Test lung 1 Liter rigid wall Airon Part 21002 After 3 breaths measure the suggested delivered tidal volume 3 Spirometer Count the respiratory rate with a 12 2 4 Watch stopwatch Measure the number breaths per Pass Fail of breaths in one minute minute When ready Remove the test lung and 1 Attach breathing circuit to ventilator as described in occlude the patient connection Section 5 on the circuit Read the circuit 50 5 cm Pass Fail 2 Attach the test lung to the patient side of the pressure from the pressure H2O breathing circuit gauge on the front of the 3 Set the controls as fo
21. cuit designed for use with the pNeuton Model A is part number 58001 6 ft disposable patient circuit The compression volume is 1ml per cm H20 Additionally a full range of compatible patient circuits are available to meet your needs Other patient circuits may become available in the future All acceptable circuits will have part numbers from 58001 to 58999 Part Description Number p 58001 6ft 1 8 m disposable box of 15 58006 6ft 1 8 m disposable with expiratory filter box of 15 6 ft 1 8 m disposable with large adult mask and head strap box of 10 6 ft 1 8 m disposable with expiratory filter large adult mask and head strap box of 10 58051 8ft 2 4 m disposable box of 15 A WARNING Patient circuits other than the Airon circuits listed above may alter the ventilator s CPAP PEEP characteristics and or expiratory flow resistance They should NOT be used and may lead to patient harm pNeuton Ventilator 5 1 warnine Do not use air filters on the expiratory port of the patient circuit except those provided by Airon Corporation Some filters may alter the ventilator s CPAP PEEP characteristics and or expiratory flow resistance They should NOT be used and may lead to patient harm N caution The pNeuton ventilator requires the use of a non vented full face mask for proper device operation Ventilator Connection The patient circuit must be attached to the ventilator properly Incorrect
22. e the ventilator will operate from a tank of oxygen The ventilator uses very little gas for its own operation less than 4 L min and is not a major factor in oxygen tank consumption The major factors are e Volume of oxygen in the tank Patient s tidal volume and rate Position of the Oxygen control If the PEEP CPAP system is on or off pNeuton Ventilator 7 7 Setting the Oxygen control to 65 will decrease the amount of oxygen used from the tank nearly doubling the time an oxygen tank lasts NOTE Always use full oxygen and air tanks before the start of any transport The calculation of any expected run time becomes unreliable as tank pressure is reduced Example of expected operating time using a full E size cylinder 660 liters PEEP CPAP off Minute Volume 100 Oxygen 65 Oxygen 5 I m 77 min 80 min 10 I m 40 min 76 min 15 I m 33 min 60 min The PEEP CPAP system when turned on uses approximately 5 L min oxygen from the tank to provide the 10 L min baseline flow of the system The patient s own spontaneous tidal volume and rate will use additional oxygen from the tank based upon the tidal volume of those breaths Example of expected operating time using a full E size cylinder 660 liters PEEP CPAP on Minute Volume 100 Oxygen 65 Oxygen 5 I m 29 min 37 min 10 I m 26 min 33 min 15 I m 23 min 30 min pNeuton Ventilator 7 8 MRI Compatibility The ventilator was engineered and built to be MRI
23. ecccceeeeeeeeseeeeeeeeeeees 10 1 Ventilator System Performance 008 10 1 Alarm SY SUC ach citar eh Sater aae 10 2 Environmental and Physical Characteristics 10 3 POWE SOUICES eari tential eae telnet 10 3 Section 11 Limited Warranty cccccceeeeeeeeeees 11 1 SECUN 12s NGSX oiia ai 12 1 pNeuton Ventilator II pNeuton Transport Ventilator Section 1 General Description pNeuton pronounced new ton is a small lightweight transport ventilator designed for use on patients from pediatric to adult in size 23 kg or greater It is atime cycled flow limited ventilator providing Intermittent Mandatory Ventilation IMV In this mode of ventilation an adjustable respiratory rate and tidal volume are delivered to the patient 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 delivered oxygen is adjustable to 65 or 100 with oxygen as the driving source gas pNeuton is a pneumatic ventilator Electrical power is not required for patient ventilation pNeuton has been specifically designed for patient support during transport and non critical care unit mechanical ventilation It may be used during intra and inter hospital transport in aircraft on ambulances in emergency rooms MRI and other radiology suites pNeuton Ventilator 1 1 pNeuton Ventilator Section 2 Wa
24. ersists send tank regulator for 100 oxygen 100 oxygen Internal malfunction Alarm does NOT activate Expiratory valve drive line kinked or occluded High patient Decrease spontaneous spontaneous ventilation ventilation Internal malfunction Send ventilator for service Visual alarm activates but audible does not pNeuton Ventilator Reed Cap Malfunction Indication Meaning Corrective Action i Patient circuit Reattach circuit or Alarm activated l disconnection locate leak Normal operation To silence alarm attach patient or test lung or press Reset Silence button Expiratory valve Insure tubing is tubing disconnected connected properly Replace patient circuit Tank may be low Check gas source 55 psi 380 kPa at 40 L min is required Set CPAP to at least 5 cm H O or Mandatory Breaths ON If peak pressure does not reach 15 cm H2O due to patient insp effort during mandatory breaths alarm will sound This is normal operation Send ventilator for service Patient circuit Check circuit occluded Check replace patient circuit Internal malfunction Send ventilator for service Replace reed cap on back of unit Section 9 Cleaning and Maintenance e This service must only be performed by Airon Corporation or its approved service technicians Cleaning the Ventilator e Failure to perform this service may result in malfunctioning of the ventilator e Use only mi
25. et Silence button Attaching the ventilator to a patient and starting ventilation will automatically reset the alarm system and turn off the audible and visual indicators pNeuton Ventilator 4 5 A patient circuit disconnect is sensed when any of the following conditions occur e Mandatory Breaths ON circuit pressure does not rise above 15 cm H20 within 22 seconds of the last time at least 15 cm H2O was sensed e Mandatory Breaths OFF a pressure of less than 5 cm H20 is sensed for 22 seconds NOTE Setting a CPAP level of less than 5 cm H20 with Mandatory Breaths OFF will cause a continuous alarm If this occurs either set CPAP to at least 5 cm H20 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 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 cumulative In other words repeatably pressing the Reset Silence button will not increase the silence time by more than 1 minute The alarm system provides a remote alarm output on the rear of the ventilator Use the Airon Remote Alarm Part number 21031 to provide a remote audible and visual indication of active alarm conditions pNeuton Ventilator 4 6 Section 5 Patient Circuit Adult Pediatric Circuit The patient cir
26. eventative Maintenance 9 1 Single Use only Devices Accessories 5 3 Specifications Alarm System 10 2 Environmental and Physical Characteristics 10 3 General Description 10 1 Power Sources 10 3 Ventilator System Performance 10 1 Spontaneous Breaths FiO 7 7 T Tidal Volume Control 3 2 Interrelationship Between Volume amp Rate Controls 7 3 Theory of Operation CPAP Demand Flow Breathing System 7 5 Mandatory Breath Pressure Control System 7 5 Oxygen Delivery System 7 6 Pneumatic System Diagram 7 1 Pneumatic System Description 7 2 Tidal Volume and Rate Control System 7 3 Troubleshooting Ventilator 8 1 V Ventilator Set up 4 1 Verification Operational 4 2 W Warnings 2 1 pNeuton Ventilator 12 4
27. iabilities Do not immerse the pNeuton Ventilator or allow any liquid to enter the case or the inlet filter Clean as directed in Section 9 Cleaning and Maintenance pNeuton Ventilator 2 3 Notes In the USA the pNeuton Ventilator is a restricted medical device intended for use by qualified medical personnel under the direction of a physician During the transport of patients it is recommended that an alternate source of ventilation be available in the event of driving gas supply failure or ventilator malfunction AR ventilator will operate normally at altitudes up to 15 000 feet Changes in altitude will not affect pressure settings but will cause the delivered tidal volume to increase and the respiratory rate to decrease as altitude increases To compensate for the effect of changing altitude on tidal volume and respiratory rate use 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 the MRI environment according to the following conditions Static magnetic field of 3 Tesla or less Maximum spatial gradient magnetic field of 720 Gauss cm IMPORTANT NOTE This product is intended for use within the MRI environment e g in the MR system room It should not be utilized directly inside of the MR system e g inside of the bore of the scanner during its operation i e scanning
28. inuous operation Ventilator System Performance e Controls o Mandatory Breaths On or Off o Respiratory Rate from 3 to 50 bom o Tidal Volume from 360 to 1 500 ml o Peak Pressure from 15 to 75 cm HzO o PEEP CPAP from 0 to 20 cm H2O Oo Oxygen 100 or 65 e Operating Ranges o Inspiratory Time 0 6 to 2 5 seconds o Expiratory Time 0 6 to 20 0 seconds o Minute Volume 0 2 to 30 L min o Flow Pattern square 36 L min o Internal P Limit 80 cm H2O e Accuracy of Controls o Respiratory Rate 10 V between 500 900 Tidal Volume 10 Peak Pressure 10 PEEP CPAP 5 F O mandatory breaths 10 OO O O pNeuton Ventilator 10 e Precision breath to breath repeatability of controls o Respiratory Rate 10 Tidal Volume 25 ml Peak Pressure 5 cm H2O PEEP CPAP 2 cm H2O FiO 5 O OOO e Specificity effect of one control on another o Respiratory Rate if tidal volume is constant 5 Tidal Volume 5 Peak Pressure 5 PEEP CPAP 5 FO 5 O O O Q e Internal Compliance 0 1 ml cm H2O e Ventilator Resistance to Flow o Inspiratory 60 L min less then 2 cm H2O l sec o Expiratory 50 L min less then 2 cm H2O I sec Alarm System e Patient Disconnect o Pressure mandatory breath OFF less than 5 cm H2O mandatory breath ON less than 15 cm H2O o Alarm delay 22 seconds o Alarm silence 60 seconds e Low Gas Supply o Input supply pressure less than 30 psi 2 1 bar o Cannot be
29. ld detergent or disinfectant and water with a soft cloth e Do not immerse the ventilator in water e Do not attempt to sterilize the ventilator with autoclave or ethylene oxide Severe damage to the ventilator may occur Cleaning Disinfecting the Patient Circuit The Airon patient circuit is a disposable single use device This circuit must not be cleaned disinfected or reused 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 and prior to use on each patient Institution s standards may require additional biomedical surveillance No additional routine maintenance is required Factory Preventative Maintenance e Ventilator service is required every 2 years to ensure continuous safety and reliability of the ventilator e Ventilator service includes o Replacement of internal filters Replacement of internal materials subject to wear Reconditioning of the enclosure Complete calibration O O O pNeuton Ventilator 9 1 pNeuton Ventilator Section 10 Specifications General Description e Pneumatically operated ventilator provides automatic mechanical ventilation with a built in PEEP CPAP demand flow system for spontaneous breathing e Patient ranges pediatric to adult gt 23 kg e Equipment not suitable for use in the presence of flammable anesthetics e Rated for cont
30. line properly connected disconnected Expiratory Valve is Replace patient malfunctioning circuit Insufficient driving Check gas source gas supply 55 psi 380 kPa at 40 L min is required Internal malfunction Send ventilator for service Ventilator CPAP may be Check CPAP control appears to be turned on high stuck in inspiration Internal malfunction Send ventilator for service Patient pressure too high Can t get the PEEP CPAP desired Ventilator using too much gas Oxygen concentration too low pNeuton Ventilator Alarms at start up when gas is supplied to ventilator Meaning Corrective Action Tidal Volume set too Decrease Tidal Pressure setting ET Tube may be occluded or patient Expiratory Valve Replace patient service Leak in the Patient Expiratory Valve Replace patient Circuit or Expiratory Valve Insufficient driving Using a circuit not gas supply alarm circuit sounds briefly during Airon each mandatory Internal malfunction Send ventilator for breath Excessive Occurs when using OFF and CPAP set to less than 5 cm system will not when H2O connected to a Excessive patient patient If problem effort ventilator for service system turned on CPAP system Leak at source gas Check hoses and leaks service Source gas not Insure source gas is Volume or Peak Patient response may be biting tube malfunctioning circuit recommended by chattering of CPAP some test lungs but p
31. llows ventilator a Mandatory Breath control to On Remove the occlusion and allow b Oxygen to 65 the breathing circuit to remain 20 3 c PEEP CPAP to Off open Using a stopwatch a d Pass Fail d Peak Pressure to 50 cm H2O measure the time until the alarm eens e Tidal volume to 700 ml sounds f Respiratory Rate to 12 bom 4 Attach Oxygen Input on rear panel of the ventilator lf the ventilator has passed all the above steps it is ready to a high pressure oxygen source and turn on the to return to clinical use If the ventilator fails to pass any of oxygen the following tests do not apply it to patients Call your local distributor or Airon Corporation Customer Support at NOTE The ventilator will begin operation at the above 888 448 1238 toll free USA amp Canada or 1 321 821 settings when the oxygen is turned on The alarm will 9433 Do not attempt to service the unit sound You may press the Reset Silence button to silence the alarm or wait for the unit to begin ventilating Desai 5 7 eN Do not disassemble the pNeuton Ventilator No internal user replaceable parts All service must be performed by Airon Corporation or an approved service technician Opening the device will negate the warranty User will be responsible for all repair costs to service the unit pNeuton Ventilator 4 1 pNeuton Ventilator 4 2 Patient Ventilation The ventilator operates with the following modes e CMV Continuous Mechanical Ven
32. ntended This twelve 12 month warranty does not extend to expendable items such as membranes hoses patient circuits and filters which are warranted to be free of defects only at time of original delivery The official ARON CORPORATION Distributor will at its option either repair or replace any defective product as above defined which is reported to that AIRON CORPORATION Distributor within 72 hours of occurrence during the warranty period If so instructed by the Distributor such defective products must be returned to the official AARON CORPORATION Distributor in the original container with freight charges prepaid In any case AIRON CORPORATION shall be responsible for repairs to or replacement of such defective product only LIMITATIONS ON AND DISCLAIMER OF WARRANTIES AIRON CORPORATION shall be relieved of any liability under this warranty if the product is not used in accordance with manufacturer s instructions if attachment or incorporation of any device is made to this product without written approval if use is made in any manner other than intended by the manufacturer if regular periodic maintenance and service is not performed if repairs are made by other than authorized AIRON CORPORATION service personnel if the product has been subject to abuse misuse negligence or accident Any product that has been mechanically or electronically altered without pNeuton Ventilator 11 1 specific written authorization from AIRO
33. or 7 9 used In addition safe MRI practice calls for all devices used in the proximity of a MRI scanner be anchored to prevent inadvertent movement Disconnect Alarm The ventilator has an internal patient circuit disconnect alarm system This system cannot be turned off Ifa circuit disconnect is sensed the visual indicator on the front panel will illuminate and the audible alarm will sound The alarm will activate as soon as an oxygen source is turned on to the ventilator Attaching the ventilator to a patient and starting ventilation will automatically reset the alarm system and turn off the audible and visual indicators 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 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 cumulative In other words repeatably pressing the Reset Silence button will not increase the silence time by more than 1 minute The alarm system is entirely pneumatic and uses no electricity A series of valves and pneumatic capacitances provide the sensing network Two subsystems are used one for when Mandatory Breaths are turned on and another for when Mandatory Breaths are turned off This allows the alarm to operate when only CPAP is functioning Due to the nature of this system a minimum CPAP of 5 cm
34. ovides a fixed flow at 36 L min or 600 ml sec during a mandatory breath setting a specific inspiratory time also sets a specific tidal volume This tidal volume is so precise that the inspiratory time control is calibrated to reflect the range of tidal volumes available 360 to 1 500 ml The ventilator s tidal volume output will not change in the face of increasing patient circuit pressure The only change that may occur to actual patient delivered tidal volume 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 circuit part number 58001 the following tidal volume patient circuit pressure relationships can be expected Patient Pressure Tidal Volume 360 ml 800 ml 1200 ml 5 cm H2O 360 800 1 200 15 cm H2O 350 785 1 180 30 cm H2O 340 775 1 165 60 cm H2O 320 750 1 145 The Respiratory Rate control adjusts expiratory time with a range 0 6 to 20 seconds Rate is controlled by increasing or decreasing expiratory time With a set tidal volume a slower respiratory rate will equate to a longer expiratory time Tidal volume is not affected by changes to the Respiratory Rate control The Respiratory Rate control is calibrated for set tidal volumes between 500 and 900 ml The calibrated pNeuton Ventilator 7 3 Respiratory Rate range optimizes the interdependence between the expiratory and inspi
35. pNeuton Transport Ventilator Model A Operators Manual REF 97011 CD A 005 Rev G Released 29 July 2015 The pNeuton Ventilator is under US patent protection Patent 6 591 835 pNeuton is a Registered Trademark of the Airon Corporation Copyright 2011 by Airon Corporation ial Manufactured by Airon Corporation F 751 North Drive Unit 6 Melbourne Florida 32934 USA Tel 888 448 1238 toll free USA amp Canada 1 321 821 9433 Fax 1 321 821 9443 www AironUSA com CE Tage Emergo Europe EC Molenstraat 15 2513 BH The Hague The Netherlands Table of Contents Section 1 General Description cccceceeeeees 1 1 Section 2 Warnings Cautions Notes 2 1 Warnings ssie nea e E 2 1 CANONS aarete 2 3 NOTOS eia Rir eee ate alate ecto 2 4 Indications for US vsisnecne a i 2 6 COntraindications S enaena 2 6 Medical Symbol Key ccccceeeeeeeee eens 2 7 Section 3 Controls and Patient Safety Systems 3 1 Front Panelaren oaa ta taderati raat dacehanlean 3 1 Rear Panel ie siete sawn sect chipper o e anin 3 3 Internal Patient Safety Systems c00 3 5 Section 4 Operating Instructions cceee 4 1 Ventilator Set UD eerca ne A 4 1 Operational Verification ccccccccceseeseeeeeeeees 4 2 Patient Ventilation siccin 4 3 Interrelationship of Volume and Rate Controls 4 4 OXV GEM CONTO lran ontatee con ieee 4 5 Hypoba
36. ratory time for ease of operation If the tidal volume is changed and the rate is not changed the number of breaths that can occur in one minute changes For example Volume 600 Respiratory Rate 12 I time 1 sec E time 4 sec total time 5 sec Change the volume to 900 I time changes to 11 2 sec Resultant Respiratory Rate is now 11 total time for inspiration and expiration 51 2 sec Volume 600 Respiratory Rate 12 I time 1 sec E time 4 sec total time 5 sec Change the volume to 1200 I 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 control Tidal volumes higher than 900 ml will result in slower rates than marked on the Respiratory Rate control The marks on the Rate Control are wide to reflect the range of control position that will provide the desired rate over the range of tidal volume Always count the respiratory rate when first placing the ventilator on a patient and whenever changing tidal volumes As when using any mechanical ventilator careful attention to detail is required It is suggested that independent validation of tidal volume and rate be performed using external spirometers and timing devices pNeuton Ventilator 7 4 Mandatory Breath Pressure Control System During normal mandatory breath inspiration the expiratory valve f
37. ric Operation cccccessseeeeeeeeeeeeeeeaeees 4 5 Disconnect Alarm ccceeccceeeeeeeeeeeeeeees 4 5 SECON O Patient Greu netrasie eee eet 5 1 Adult Pediatric Circuit cccssscecsseeeeeeeeees 5 1 Ventilator Connection ccccceseeeeeeeeeeeeeeeees 5 2 Single Use only Devices Accessories 5 3 Section 6 Accessories ccc cece eee ence eeee cease 6 1 Section 7 Theory of Operation ccccceesseeeees 7 1 Pneumatic System Diagram ccccseeeeeeee 7 1 Pneumatic System Description 0 ccceeees 7 2 Tidal Volume and Rate Control System 7 3 Mandatory Breath Pressure Control System 7 5 oNeuton Ventilator CPAP Demand Flow Breathing System 7 5 Oxygen Delivery System cccccceeceeeseeeeeeeees 7 6 MRT COMmpPaupn ily soe each catches eae actes 7 9 Disconnect Alarm is ducindctindeciadubindashicaddweaels 7 10 Low Gas Supply Alarm cccceeeeeee eens 7 11 Section 8 Troubleshooting ccccceecceeseeeeeeeeeeees 8 1 Section 9 Cleaning and Maintenance 9 1 Cleaning the Ventilator ccccecceeesseeeeeeees 9 1 Cleaning Disinfecting the Patient Circuit 9 1 Routine Maintenance ccccccsseeeseeeeseeeeees 9 1 Factory Preventive Maintenance 006 9 1 Section 10 Specifications cccceeeeeecsseeeeeeeeeeees 10 1 General Description c
38. rnings Cautions Notes The pNeuton Ventilator is intended for use by properly trained personnel under the direct supervision of licensed medical Physician or Practitioner only Personnel must become thoroughly familiar with this Operators Manual prior to using the pNeuton Ventilator on a patient As used in this manual the following terms mean Warning Indicates the possibility for injury to the patient or the operator Caution Indicates the possibility of damage to the device Note Places 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 pNeuton Ventilator The operator should read and understand this entire manual before using the pNeuton Ventilator po NOT use the pNeuton Ventilator in conjunction with anesthetics or in contaminated hazardous explosive atmospheres Only compressed oxygen may be used po NOT use conductive anti static patient breathing circuits The only approved patient circuits for use with pNeuton Ventilator are the Airon circuits listed in Section 5 of this manual Any other patient circuit should NOT be used and may lead to patient harm pNeuton Ventilator 2 1 N the Operational Verification tests as described in this manual Section 4 must be performed prior to connecting a patient to the ventilator If the ventilator fails any of the tests it
39. s longer Eventually the regulator is unable to maintain pressure and the alarm will sound continuously until all gas in the cylinder is used J WARNING The Low Gas Supply Alarm will only activate for a very short period of time if the gas supply abruptly ceases This can occur if operating from a wall source and the gas supply hose is disconnected from the gas supply outlet In fact the Low Gas Supply Alarm may not sound at all when the ventilator is disconnected from a wall source This is because all gas in the high pressure hose immediately exits out from where the hose was connected to the outlet and there is no gas pressure to pNeuton Ventilator 7 11 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 pNeuton Ventilator 7 12 Section 8 Troubleshooting Indication Meaning Lower minute Check gas source volume than gas supply 55 psi 380 kPa at This troubleshooting guide lists common problems that desired 40 L min is required may be encountered and possible solutions If none of the Leak in the Patient Replace patient corrective actions seem to work contact Airon Corporation Circuit or Expiratory circuit or your distributor Valve Obstruction of gas Check or replace output patient circuit Use in hyperbaric Ventilator should not condition be used in hyperbaric conditions out of calibration service service Higher
40. taining the correct tidal volume The high flow venturi provides stable performance up to the maximum operating pressure 75 cm H20 of the ventilator pNeuton Ventilator 7 6 Spontaneous Breaths Spontaneous breaths are available from the internal CPAP system which uses a venturi mechanism separate from the mandatory breath high flow venturi When turned on by the PEEP CPAP control the system delivers approximately 10 L min baseline flow during the expiratory time of the ventilator The F Oz of this system is set by the Oxygen control When set for 65 the actual oxygen percentage and baseline flow is related to the level of CPAP in use Up to 10 cm H2O CPAP will provide a FiO of approximately 0 65 0 10 As the CPAP level raises to 20 cm H20 the F O2 can be expected to increase to as high as 0 75 0 10 This is due to a drop off in efficiency stalling of the CPAP venturi system at higher CPAP levels The actual FiO of spontaneous breaths will be approximately the same as the baseline flow Whether set for 65 or 100 extremely high inspiratory flow demand may decrease the desired F Os It is recommended that an external oxygen monitor be used at all times to measure and display the delivered oxygen concentration A WARNING Never operate the ventilator without proper oxygen gas supply at the required pressure Factors Effecting the Operating Time of Oxygen Tanks There are several factors that affect the length of tim
41. tely 10 L min during the pNeuton Ventilator 7 9 expiratory time of the ventilator This flow of gas helps to establish the desired CPAP level by balancing flow with the pressure generated on the expiratory valve by the CPAP system 2 The continuous flow of gas also establishes the flow sensitivity to spontaneous breathing efforts If the patient s inspiratory flow demand exceeds the continuous flow of gas additional flow will be added to meet patient demand There is no sensitivity adjustment to this system The CPAP system will automatically meet the needs of the patient greater than 100 L min by attempting to maintain the balance between flow and pressure at the expiratory valve 3 The PEEP CPAP 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 System With the ventilator driven by 100 oxygen as the source gas the ventilator can be set to deliver 65 or 100 oxygen There are two independent systems within the ventilator that determine oxygen concentration The following section describes how these systems operate Mandatory Breaths The Oxygen control determines the oxygen concentration of the mandatory breaths that enter the patient circuit at the Patient Connection When set for 65 an internal high flow venturi system entrains ambient air to decrease the FiO while main
42. tilation e IMV Intermittent Mandatory Ventilation e CPAP Continuous Positive Airway Pressure Using the Intermittent Mandatory Ventilation IMV mode the ventilator provides an adjustable number of breaths per minute The tidal volume of these breaths is also adjustable The patient may breathe spontaneously between ventilator breaths as desired 1 Set the Oxygen control to the desired F Oz 2 Set the Mandatory Breath control to On 3 Set the Tidal Volume control to the appropriate level 4 Adjust 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 and observing the level of pressure generated during a mandatory breath 6 Attach the patient circuit to the patient and observe for appropriate ventilation Adjust as required External measurement devices should to used to verify ventilation parameters 7 Adjust the PEEP CPAP control to the desired level There is no adjustment for spontaneous breath trigger sensitivity as this is automatically set by the ventilator 8 Observe and monitor the patient and the ventilator per your institution s standards If using a portable gas supply monitor the supply level to insure there is sufficient gas for ventilation pNeuton Ventilator 4 3 Interrelationship of Volume and Rate Controls There is an interrelationship between the Tidal
43. tric patient circuit Disposable single patient use IL 6 foot 1 8m and 8 foot 2 4m length gre ccc ce a eee ee pNeuton Ventilator a Ee Test Lung A rigid wall Test Lung is ideal to test device performance and 3 create spontaneous breaths nnn 4 Bed Rail Mount MRI compatible Bed Rail Mount _ Allows the pNeuton ventilator to hang from standard critical _ care bed rails and stretchers Mount fits securely onto the top of the ventilator and provides a sturdy support during patient transport 3 Adult pediatric CPAP Masks Disposable single patient use Adult Small Adult Medium Adult Large ca a ee er ee ee eens Remote Alarm Respironics Model 34003 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 pNeuton Ventilator 3 50 foot 15 m cable 100 foot 30 m cable ae a a a a a a a pe a a a a a a a a a a a a oe oe ee ee ee 3 Oxygen Regulator MRI compatible high pressure oxygen regulator for D E size we oe oe oe oe oe oe oe ew ww wn oS ewe ww ww ww ww ew ew een ww wn on on wn on wn en wn ee en we ww ww we wen wo ono Oxygen Cylinder E Size MRI compatible A 600 liter green oxygen cylinder with yoke stem valve _ High Pressure Oxygen
44. unctions to prevent gas from escaping through the expiratory valve The pressure used to close the expiratory valve is set with the Peak Pressure control The range is 15 to 75 cm H20 The Peak Pressure adjustment can be used to manipulate the highest pressure applied during mandatory breaths If volume limited ventilation is the goal set the Tidal Volume control to the desired volume and the Peak Pressure control to at least 10 cm H2O above the pressure required to deliver that tidal volume If pressure limited ventilation is the goal set the Tidal Volume control 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 maintaining the desired peak pressure This flow release may cause a honking sound as gas escapes through the partially closed valve The Peak Pressure control can be tested by occluding the patient port of the patient circuit during a mandatory breath During the breath the pressure will rapidly rise to the set peak pressure Turn the Peak Pressure control until the desired peak pressure is achieved CPAP Demand Flow Breathing System The ventilator s internal CPAP demand flow system provides gas for spontaneous breathing at adjustable CPAP pressures up to 20 cm H20 This system has several key features 1 When turned on the system supplies a continuous flow of gas at approxima

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