pNeuton Transport Ventilator Operators Manual Model A Rev I Rel 8 June 2017

Mandatory Breath Pressure Control System ... 7-5 CPAP Demand Flow Breathing System ... 7-5 Oxygen Delivery System ... 7-6 MRI Compatibility ... 7-9 Disconnect Alarm ……………………………….. 7-10 Low Gas Supply Alarm …………………………. 7-11

Table of Contents

Section 1. General Description ... 1-1 Section 2. Warnings, Cautions, Notes ... Warnings ... Cautions ... Notes ... Indications for Use ... Contraindications ... Medical Symbol Key ……………………………

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Section 8. Troubleshooting ... 8-1 Section 9. Cleaning and Maintenance ... Cleaning the Ventilator ... Cleaning / Disinfecting the Patient Circuit ... Routine Maintenance ... Factory Preventive Maintenance...

Section 3. Controls and Patient Safety Systems .. 3-1 Front Panel ... 3-1 Rear Panel ... 3-3 Unique Device Identifier ……………………….. 3-5 Internal Patient Safety Systems ... 3-6

Section 10. Specifications ... 10-1 General Description ... 10-1 Ventilator System Performance ... 10-1 Alarm System …………………………………… 10-2 Environmental and Physical Characteristics ... 10-3 Power Sources ... 10-3

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 Control ... 4-5 Hypobaric Operation ... 4-5 Disconnect Alarm ……………………………….. 4-5 Section 5. Patient Circuit ... Adult / Pediatric Circuit ... Ventilator Connection ... Single-Use only Devices/Accessories ………..

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Section 11. Limited Warranty ... 11-1 Section 12. Index ... 12-1

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Section 6. Accessories …………………………….. 6-1 Section 7. Theory of Operation ... 7-1 Pneumatic System Diagram ... 7-1 Pneumatic System Description ... 7-2 Tidal Volume and Rate Control System ... 7-3 pNeuton Ventilator

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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 a time 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.

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Section 2: Warnings, 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. DO NOT use the pNeuton Ventilator in conjunction with anesthetics or in contaminated (hazardous, explosive) atmospheres. Only compressed oxygen may be used. DO 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.

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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 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. 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. 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. 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 volume with a hyperbaric compatible external spirometer is mandatory.

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The pNeuton Ventilator is MRI Conditional up to 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 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 DO 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 liabilities.

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. The 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). 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.

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.

Airon recommends that users perform similar tests in their MRI scanner prior to patient use.

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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.

Indications for Use The pNeuton Ventilator is intended for continuous mechanical ventilation of patients in the following patient populations and use locations:

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 I to Directive 67/548/EEC.

Patient population - adult / pediatric patients 23 Kg and greater who require the following general types of ventilatory support:  positive pressure ventilation delivered invasively (via an ET tube) or non-invasively (via a mask)  CMV and IMV modes of ventilation  with or without PEEP / CPAP  with oxygen or a mixture of air and oxygen

Additional Warnings, Cautions, and Notes are located throughout this manual.

The ventilator is suitable for use in:  Pre-hospital transport applications including accident scene, emergency rescue vehicles  Hospital ICU transport applications including emergency, radiology, surgery, postanesthesia/recovery and MRI departments  Air transport via helicopter or fixed wing

Contraindications The following conditions contraindicate the use of the pNeuton Ventilator:  Patients undergoing procedures with flammable anesthetic gasses  Patients undergoing hyperbaric treatment  Infants and neonatal patients requiring tidal volumes less than 360 ml.

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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.

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Section 3: Controls and Patient Safety Systems PEEP / CPAP control, calibrated, range 0 to 20 cm H2O

Front Panel

Tidal Volume 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

Pressure gauge, patient circuit pressure

Alarm Reset / Silence, 1 minute

Peak Pressure control of mandatory breaths, calibrated, range 15 to 75 cm H2O

Mandatory Breath control, turns on or off mandatory breath system

Oxygen control, select either 100% or 65%

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Patient Circuit connection, see Section 5 for a complete description of the patient circuit and it's attachment to the front panel

Driving Gas Input (oxygen), DISS connection, requires 55 + 15 psi (380 + 100 kPa), (40 liter/minute minimum)

Expiratory Valve connection Alarm, Low Driving Gas

Ambient Air Inlet Filter

Rear Panel

Remote Alarm output

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Unique Device Identification (UDI)

Internal Patient Safety Systems

Pursuant to the U.S. FDA Unique Device Identification (UDI) Rule, each device must bear a UDI code. The UDI for pNeuton ventilator is located under the “Serial Number:” labeling, in plain text, on the back panel of the device. The UDI code consists of one Device Identifier (DI) and potentially four Production Identifiers (PI). Therefore, UDI = DI+PI. Production identifiers are required if the information appears on the product (box) label. The UDI on the product (box) label appears in both plain 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 Date (17) Expiration Date (21) Serial Number

The ventilator has several internal safety systems. These systems insure patient safety in the event of ventilator malfunction.

The format for Manufacturing / Production date and Expiration date within the UDI code is: YYMMDD  YY = tens and units of the year (e.g. 2014 = 14)  MM = number of the month (e.g. January = 01)  DD = number of the day (e.g. third day = 03)  January 03, 2014 = 140103 An example UDI for the pNeuton ventilator is as follows:

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 H2O. The factory preset value is 50 cm H2O. 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 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).

Device Identifier = 00853678006009 Serial Number = A0000 The Device Identifier portion of the code may be entered into AccessGUDID to obtain information about the product. http://accessgudid.nlm.nih.gov/ pNeuton Ventilator

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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

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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:  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 pressure is less than 5 cm H2O 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.

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Section 4: Operating Instructions

Operational Verification

Ventilator Set-up

Verification Step

The following equipment is needed: 1. pNeuton Ventilator with breathing circuit (see Section 5 for a list of compatible circuits.) 2. Test lung, (1 Liter rigid wall, Airon Part # 21002 suggested) 3. Spirometer 4. Watch

Attach a spirometer to the expiratory valve using the elbow included in the circuit packaging. After 3 breaths measure the delivered tidal volume. Count the respiratory rate with a stopwatch. Measure the number of breaths in one minute. Remove the test lung and occlude the patient connection on the circuit. Read the circuit pressure from the pressure gauge on the front of the ventilator. Remove the occlusion and allow the breathing circuit to remain open. Using a stopwatch, measure the time until the alarm sounds

When ready: 1. Attach breathing circuit to ventilator as described in Section 5. 2. Attach 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 to 700 ml f. Respiratory Rate to 12 bpm 4. Attach Oxygen Input on rear panel of the ventilator to a high pressure oxygen source and turn on the oxygen. NOTE: The ventilator will begin operation at the above settings when the oxygen is turned on. The alarm will sound. You may press the “Reset / Silence” button to silence the alarm or wait for the unit to begin ventilating.

Acceptable Range

Result

700 ± 70 ml

Pass / Fail

12 ± 2 breaths per minute

Pass / Fail

50 ± 5 cm H2O

Pass / Fail

22 ± 3 seconds

Pass / Fail

If the ventilator has passed all the above steps it is ready to return to clinical use. If the ventilator fails to pass any of the following tests do not apply it to patients. Call your local distributor or Airon Corporation Customer Support at 888-448-1238 (toll free USA & Canada) or +1-321-8219433. Do not attempt to service the unit. CAUTION: 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.

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Patient Ventilation

Interrelationship of Volume and Rate Controls

The ventilator operates with the following modes:  CMV - Continuous Mechanical Ventilation  IMV - Intermittent Mandatory Ventilation  CPAP - Continuous Positive Airway Pressure

There is an interrelationship between the Tidal 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.

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. 2. 3. 4. 5.

6.

7.

8.

Set the % Oxygen control to the desired FIO2. Set the Mandatory Breath control to On. Set the Tidal Volume control to the appropriate level. Adjust the Respiratory Rate control to achieve the desired mandatory breath frequency. 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. 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. 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. 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.

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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 required, a lower tidal volume may be necessary. Likewise, if a high tidal volume is required, a lower respiratory rate may be needed.

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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.

A patient circuit disconnect is sensed when any of the following conditions occur:  Mandatory Breaths “ON” – circuit pressure does not rise above 15 cm H2O within 22 seconds of the last time at least 15 cm H2O was sensed.  Mandatory Breaths “OFF” – a pressure of less than 5 cm H2O is sensed for 22 seconds NOTE: Setting a CPAP level of less than 5 cm H2O with Mandatory Breaths OFF will cause a continuous alarm. If this occurs, either set CPAP to at least 5 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 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.

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 Reset / 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

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Section 5: Patient Circuit

WARNING: 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.

Adult / Pediatric Circuit

The patient circuit designed for use with the pNeuton Model A is part number 58001, 6 ft. disposable patient circuit. The compression volume is 1ml per cm H2O.

CAUTION: The pNeuton ventilator requires the use of a non-vented full-face mask for proper device operation.

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.

Ventilator Connection

Part Number 58001 58006 58011 58021 58051

The patient circuit must be attached to the ventilator properly. Incorrect attachment could result in failure to provide adequate ventilation.

Description The main breathing hose (22 mm) is connected to the “Patient Connection” port.

6 ft. (1.8 m) disposable, box of 15 6 ft. (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 8 ft. (2.4 m) disposable, box of 15

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.

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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.

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Single-Use only Medical Devices/Accessories How do I 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 SingleUse? 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:  Cross-infection – inability to clean and decontaminate due to design, device components are not manufactured for disassembly and reassembly  Endotoxin reaction – excessive bacterial breakdown products, which cannot be adequately removed by cleaning  Patient injury – device failure from reprocessing or reuse because of fatigue or material alteration  Chemical burns or sensitization – residues from chemical decontamination agents on materials that can absorb chemicals NOTE: If you reuse a single-use device you may be legally liable for the safe performance of the device. pNeuton Ventilator

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- Mount fits securely onto the top of the ventilator and provides a sturdy support during patient transport.

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.

Adult/pediatric CPAP Masks– Disposable, single patient use. Adult Small Adult Medium Adult Large

Adult/pediatric patient circuit - Disposable, single patient use. - 6 foot (1.8m) and 8 foot (2.4m) length

Remote Alarm Respironics Model 1118941 - Allows the user to attach a remote alarm to the pNeuton Ventilator. Great for the MRI control room.

Bacterial/Viral Filter Disposable, single patient 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 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 the stand for transport.

Remote Alarm Cables MRI compatible BNC cables to attach the remote alarm to the pNeuton Ventilator. 50 foot (15 m) cable 100 foot (30 m) cable Oxygen Regulator MRI compatible high pressure oxygen regulator for D / E size oxygen tanks.

Test Lung A rigid wall Test Lung is ideal to test device performance and create spontaneous breaths.

Oxygen Cylinder E Size MRI compatible – A 600 liter green oxygen cylinder with yoke stem valve.

Bed Rail Mount MRI compatible Bed Rail Mount - Allows the pNeuton ventilator to hang from standard critical care bed rails and stretchers. pNeuton Ventilator

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High Pressure Oxygen Hose DISS Female both ends MRI compatible. 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 circuit, autoclavable - 1.8 meters (6 ft) Available for International Customers Only.

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Section 7: Theory of Operation

Pneumatic System Description

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

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The major components of the pneumatic system and the control of gas flow through the ventilator are as follows: 1. High pressure gas (oxygen) enters the ventilator and is filtered (5 micron) and reduced to a lower working pressure (35 psi - 240 kPa). 2. The timing circuit uses two precision control valves to control inspiratory and 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. 3. 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 FIO2 (approximately 65%). The high flow venturi provides stable performance (no stall) up to the maximum operating pressure (75 cm H2O) of the ventilator. 4. 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. 5. The adjustable PEEP / CPAP system directs a pressure signal to the expiratory valve to generate PEEP and provides flow on demand for spontaneous breaths.

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Tidal Volume and Rate Control System pNeuton’s Tidal Volume and Respiratory Rate controls function to determine mandatory breath inspiratory and expiratory time.

Respiratory Rate range optimizes the interdependence between the expiratory and inspiratory 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:

Since the ventilator provides 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).

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 1½ sec) Resultant Respiratory Rate is now 11 (total time for inspiration and expiration = 5½ sec)

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:

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)

Patient Pressure 5 cm H2O 15 cm H2O 30 cm H2O 60 cm H2O

360 ml 360 350 340 320

Tidal Volume 800 ml 1200 ml 800 1,200 785 1,180 775 1,165 750 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.

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.

The Respiratory Rate control is calibrated for set tidal volumes between 500 and 900 ml. The calibrated pNeuton Ventilator

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pNeuton Ventilator

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