97041 pNeuton mini Operators Manual Rev J June 2019

The pNeuton® Ventilator is under US patent protection. (Patent # 6,591,835) pNeuton is a Registered Trademark of the Airon Corporation Copyright © 2012 by Airon Corporation

Manufactured by: Airon Corporation 751 North Drive Unit 6 Melbourne, Florida 32934 USA Tel: 888-448-1238 (toll free USA & Canada) +1-321-821-9433 Fax: +1-321-821-9443

www.AironUSA.com

Table of Contents

Section 1. General Description ... Indications for Use ... Contraindications ...

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Section 2. Warnings, Cautions, Notes ... Warnings ... Cautions ... Notes ...….. Medical Symbol Key ……………………………

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Section 3. Controls and Patient Safety Systems .. 3-1 Front Panel ... 3-1 Side Panel ... 3-4 Unique Device Identifier……………………….. 3-6 Internal Patient Safety Systems ... 3-7 Section 4. Operating Instructions ... 4-1 Ventilator Set-up ... 4-1 Operational Verification ... 4-2 Patient Ventilation ... 4-3 Inspiratory and Expiratory Time Controls…….. 4-4 Peak Pressure and Continuous Flow Controls. 4-5 PEEP/CPAP Control …………………………… 4-6 Oxygen Control ... 4-6 High Pressure Alarm …………………………… 4-6 Disconnect Alarm ………………………………. 4-7 Hypobaric Operation ... 4-8 Section 5. Patient Circuit ... 5-1 Infant / Pediatric Circuit ... 5-1 Ventilator Connection ... 5-2 Single-Use only Devices/Accessories ……….. 5-3 Section 6. Accessories ……………………………. 6-1 Section 7. Theory of Operation ... 7-1 pNeuton mini Ventilator

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Pneumatic System Diagram ... 7-1 Pneumatic System Description ... 7-2 Management of Patient Tidal Volume ……..…. 7-3 CPAP System ...……………………………. 7-4 Oxygen Delivery System ... 7-5 MRI Compatibility ...…. 7-7 High Pressure Alarm …………………………… 7-8 Disconnect Alarm ……………………………….. 7-9 Low Gas Supply Alarm …………………………. 7-10 Section 8. Troubleshooting ... 8-1 Section 9. Cleaning and Maintenance ... 9-1 Cleaning the Ventilator ... 9-1 Cleaning / Disinfecting the Patient Circuit ... 9-1 Routine Maintenance ... 9-1 Factory Preventative Maintenance... 9-1 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 11. Limited Warranty ... 11-1 Section 12. Index ... 12-1

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pNeuton mini Transport Ventilator Section 1: General Description

The pNeuton (pronounced "new-ton") mini is a small, lightweight transport ventilator designed for use on patients from neonatal to child in size, 400 grams to 25 kg. It is a time cycled, flow limited ventilator providing Intermittent Mandatory Ventilation (IMV). In this mode of ventilation, an adjustable inspiratory time, expiratory time, and flow 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 from 21% to 100%, with oxygen and compressed air as the driving source gas. The pNeuton mini is a pneumatic ventilator. Electrical power is not required for patient ventilation. mini 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 delivery suites, emergency rooms, MRI and other radiology suites.

Indications for Use The pNeuton mini Ventilator is intended for continuous mechanical ventilation of patients in the following patient populations and use locations: Patient population – neonatal / infant / child patients 400 grams to 25 Kg who require the following general types of ventilatory support: • positive pressure ventilation delivered invasively (via an ET tube) or non-invasively (via a mask or nasal prongs) pNeuton mini Ventilator

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• • •

CMV and IMV modes of ventilation with or without PEEP / CPAP with oxygen or a mixture of air and oxygen

The ventilator is suitable for use in: • Inter and intra-hospital patient transport • Hospital ICU transport applications including delivery rooms, emergency, radiology, surgery, post-anesthesia / recovery and MRI departments • Air & ground transport – pressurized and nonpressurized aircraft (to 15,000 ft)

Contraindications The following conditions contraindicate the use of the pNeuton mini Ventilator: • Patients undergoing procedures with flammable anesthetic gasses • Patients undergoing hyperbaric treatment • Patients requiring tidal volumes greater than 500 ml.

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Section 2: Warnings, Cautions, Notes

The pNeuton mini 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 mini 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 mini Ventilator. The operator should read and understand this entire manual before using the pNeuton mini Ventilator. DO NOT use the pNeuton mini Ventilator in conjunction with anesthetics or in contaminated (hazardous, explosive) atmospheres. Only compressed oxygen and air may be used. DO NOT use conductive (anti-static) patient breathing circuits. The only approved patient circuits for use with pNeuton mini 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 mini Ventilator

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Two different diameter patient circuits are used with the pNeuton mini, based upon patient size. The 10 mm ID circuit is designed for neonatal and infant patients. The 15 mm ID circuit is designed for children and pediatric patients. DO NOT use the 10 mm neonatal circuit on large children or at inspiratory flows of 10 L/min or higher. The proper attachment of the circuit’s small tubing to the Expiratory Valve and Proximal Pressure connections of the ventilator are very important. Connecting the tubes to the wrong connectors will cause the ventilator to malfunction and not provide ventilation. DO NOT cross connect these tubes. The Airon patient circuit is a single use, disposable device. Cleaning, reprocessing and / or reuse of this device is not recommended. Reprocessing may cause a change in ventilation characteristics. The circuit and all components are sold clean and non-sterile. 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 have been completed by an Airon approved repair facility and all operational verification tests are acceptable. The pNeuton mini Ventilator has been designed for use on neonatal, infant and child patients. The pNeuton mini cannot deliver operator adjusted tidal volumes greater than 500 ml. DO NOT use the pNeuton mini Ventilator on adult patients. To protect the patient from high airway pressures, insure that the Peak Pressure control is adjusted appropriately. pNeuton mini Ventilator

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The pNeuton mini 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. The pNeuton mini Ventilator is MRI Conditional (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 an MRI scanner, including pNeuton mini, be anchored to prevent inadvertent movement. The ventilator will cease to operate properly if the oxygen supply drops below 40 psi (280 kPa, 2.8 bar). Gas may still flow through the ventilator from the internal blender if the compressed air source is active, but mechanical breaths will cease. The Low Gas Supply Alarm will occur if the driving gas supply drops below safe levels (40 psi, 280 kPa) or if the difference between the two gas supply pressure is more than 15 psi (100 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 Insure that clean, dry medical grade compressed air is pNeuton mini Ventilator

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used at all times. Compressed air that is contaminated with water or other material will damage the internal components of the ventilator. DO NOT obstruct or cover the holes on the left side of the ventilator where the audible alarm is located. Doing so may decrease the sound level of the audible alarm. 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. Do not immerse the pNeuton mini Ventilator or allow any liquid to enter the case or the oxygen / medical air inlets. Clean as directed in Section 9, Cleaning and Maintenance.

Notes In the USA the pNeuton mini 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 inspiratory time to increase and the expiratory time to decrease as altitude increases. To pNeuton mini Ventilator

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compensate for the effect of changing altitude on tidal volume and respiratory rate, use an external spirometer to verify tidal volume accuracy. Extremely short inspiratory or expiratory time settings (0.25 seconds) may result in operational variance from the control knob labeling. If using such short time settings, measurement of actual delivered time is recommended. The pNeuton mini Ventilator is MRI Conditional. Nonclinical testing demonstrated that the pNeuton mini Infant 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. Airon recommends that users perform similar tests in their MRI scanner prior to patient use. Special note on the presence of latex: The components, devices, accessories, and packaging that make up the pNeuton mini 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 mini Ventilator system do not contain any phthalates which are classified pNeuton mini Ventilator

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as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC. Additional Warnings, Cautions, and Notes are located throughout this manual.

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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

Front Panel

Pressure gauge, patient circuit pressure

Mode control, puts the ventilator into either the CPAP or IMV + CPAP modes

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PEEP / CPAP control, calibrated, range 0 to 20 cm H2O

Peak Pressure (PINSP) control of mandatory breaths, calibrated, range 15 to 60 cm H2O

Flow (VINSP) control, sets the continuous flow through the patient circuit at 6, 8, 10, 15 or 20 L/min

Inspiratory Time (TI) control, calibrated, range 0.25 to 2.0 seconds

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Expiratory Time (TE) control, calibrated, range 0.25 to 20.0 seconds

Oxygen (FIO2) control, calibrated, range 21% to 100%

Alarm visual indicator

Alarm Reset / Silence, 10 second alarm, 25 second silence

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High Pressure Alarm (PALARM) control, range 10 to 70 cm H2O

Side Panel

Driving Gas Input (oxygen), requires 55 + 15 psi (380 + 100 kPa, 3.8 + 1 bar), (25 L/min minimum)

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Driving Gas Input (air), requires 55 + 15 psi (380 + 100 kPa, 3.8 + 1 bar), (25 L/min minimum)

Remote Alarm output

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

Expiratory Valve connection

Proximal patient pressure connection

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Unique Device Identification (UDI) Pursuant to the U.S. FDA Unique Device Identification (UDI) Rule, each device must bear a UDI code. The UDI for pNeuton mini 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 machinereadable 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 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 mini is as follows:

Device Identifier = 00853678006023 Serial Number = I0000 The Device Identifier portion of the code may be entered into AccessGUDID to obtain information about the product.

http://accessgudid.nlm.nih.gov/ pNeuton mini Ventilator

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