Airon pNeuton A Operator's Manual

Transport ventilator

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pNeuton

Transport Ventilator

Model A

Operators Manual

97011

CD-A-005 Rev J

Released 1 Feb 2019

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Summary of Contents for Airon pNeuton A

Page 1 ® pNeuton Transport Ventilator Model A Operators Manual 97011 CD-A-005 Rev J Released 1 Feb 2019...
Page 2 ® 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 Manufactured by: ® Airon Corporation 751 North Drive Unit 6 Melbourne, Florida 32934 Tel: 888-448-1238 (toll free USA &...
Page 3: Table Of Contents
Table of Contents Section 1. General Description ......1-1 Section 2. Warnings, Cautions, Notes ....2-1 Warnings ............2-1 Cautions ............2-3 Notes .............. Indications for Use .......... 2-6 Contraindications ..........2-6 Medical Symbol Key …………………………… 2-7 Section 3. Controls and Patient Safety Systems .. 3-1 Front Panel ............
Page 4 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 Section 8. Troubleshooting ........8-1 Section 9. Cleaning and Maintenance ....9-1 Cleaning the Ventilator ........
Page 5: Section 1. General Description
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).
Page 6 pNeuton Ventilator 1 - 2...
Page 7: Section 2. Warnings, Cautions, Notes
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.
Page 8 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.
Page 9: Cautions
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 Ventilator or allow any liquid to enter the case or the inlet filter.
Page 10: Notes
3-Tesla MR system only. Airon recommends that users perform similar tests in their MRI scanner prior to patient use. pNeuton Ventilator...
Page 11 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...
Page 12: Indications For Use
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: ...
Page 13: Medical Symbol Key
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...
Page 14 pNeuton Ventilator 2 - 8...
Page 15: Section 3. Controls And Patient Safety Systems
Section 3: Controls and Patient Safety Systems Front Panel Pressure gauge, patient circuit pressure Peak Pressure control of mandatory breaths, calibrated, range 15 to 75 cm H pNeuton Ventilator 3 - 1...
Page 16 PEEP / CPAP control, calibrated, range 0 to 20 cm 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 Alarm Reset / Silence, 1 minute Mandatory Breath control, turns on or off mandatory...
Page 17: Rear Panel
Patient Circuit connection, see Section 5 for a complete description of the patient circuit and it's attachment to the front panel Expiratory Valve connection Rear Panel pNeuton Ventilator 3 - 3...
Page 18 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 pNeuton Ventilator 3 - 4...
Page 19 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 ventilator is located under the “Serial Number:” labeling, in plain text, on the back panel of the device.
Page 20: Internal Patient Safety Systems
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 H O.
Page 21 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.
Page 22 pNeuton Ventilator 3 - 8...
Page 23: Section 4. Operating Instructions
Ventilator Set-up 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 When ready: 1.
Page 24: Operational Verification
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.
Page 25: Patient Ventilation
Patient Ventilation The ventilator operates with the following modes:  CMV - Continuous Mechanical Ventilation  IMV - Intermittent Mandatory Ventilation  CPAP - Continuous Positive Airway Pressure Using the Intermittent Mandatory Ventilation (IMV) mode, the ventilator provides an adjustable number of breaths per minute.
Page 26: Interrelationship Of Volume And Rate Controls
Interrelationship of Volume and Rate Controls 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.
Page 27: Oxygen Control
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.
Page 28 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.
Page 29: Section 5. Patient Circuit
10 58051 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.
Page 30: Ventilator Connection
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.
Page 31: Single-Use Only Devices/Accessories
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.
Page 32 pNeuton Ventilator 5 - 4...
Page 33: Section 6. Accessories
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 patient circuit - Disposable, single patient use.
Page 34 - Mount fits securely onto the top of the ventilator and provides a sturdy support during patient transport. Adult/pediatric CPAP Masks– Disposable, single patient use. Adult Small Adult Medium Adult Large Remote Alarm Respironics Model 1118941 - Allows the user to attach a remote alarm to the pNeuton Ventilator.
Page 35 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...
Page 36 pNeuton Ventilator 6 - 4...
Page 37: Section 7. Theory Of Operation
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 pNeuton Ventilator...
Page 38: Pneumatic System Description
Pneumatic System Description 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).
Page 39: Tidal Volume And Rate Control System
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:...
Page 40 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: Volume = 600, Respiratory Rate = 12 (I time = 1 sec, E time = 4 sec, total time = 5 sec) Change the volume to 900...
Page 41: Mandatory Breath Pressure Control System
Mandatory Breath Pressure Control System During normal mandatory breath inspiration the expiratory valve functions 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 H The Peak Pressure adjustment can be used to manipulate the highest pressure applied during mandatory breaths.
Page 42: Oxygen Delivery System
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 H O PEEP / CPAP range.
Page 43 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.
Page 44 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.
Page 45: Mri Compatibility
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...
Page 46: Disconnect Alarm
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. If a circuit disconnect is sensed, the visual indicator on the front panel will illuminate and the audible alarm will sound.
Page 47: Low Gas Supply Alarm
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.
Page 48 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...
Page 49: Section 8. Troubleshooting
Section 8: Troubleshooting This troubleshooting guide lists common problems that may be encountered and possible solutions. If none of the corrective actions seem to work, contact Airon Corporation or your distributor. Indication Meaning Corrective Action Ventilator does Missing or Check gas source, not operate –...
Page 50 Indication Meaning Corrective Action Lower minute Insufficient driving Check gas source, volume than gas supply 55 psi (380 kPa) at desired 40 L/min is required Leak in the Patient Replace patient Circuit or Expiratory circuit Valve Obstruction of gas Check or replace output patient circuit Use in hyperbaric...
Page 51 Expiratory Valve Replace patient PEEP / CPAP malfunctioning circuit desired Using a circuit not Replace patient recommended by circuit Airon Internal malfunction Send ventilator for service Excessive Occurs when using “chattering” of CPAP some test lungs but system will not when connected to a patient.
Page 52 Indication Meaning Corrective Action Patient circuit Reattach circuit or Alarm activated disconnection locate leak Alarms at start-up Normal operation. when gas is To silence alarm, supplied to ventilator attach patient (or test lung) or press Reset / Silence button Expiratory valve Insure tubing is tubing disconnected connected properly...
Page 53: Section 9. Cleaning And Maintenance
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.
Page 54  This service must only be performed by Airon Corporation or its approved service technicians.  Failure to perform this service may result in malfunctioning of the ventilator. pNeuton Ventilator 9 - 2...
Page 55: Section 10. Specifications
Section 10: Specifications General Description  Pneumatically operated ventilator provides automatic mechanical ventilation with a built-in PEEP / CPAP demand flow system for spontaneous breathing  Patient ranges: pediatric to adult, > 23 kg.  Equipment not suitable for use in the presence of flammable anesthetics ...
Page 56: Alarm System
 Precision - breath to breath repeatability of controls Respiratory Rate + 10% Tidal Volume + 25 ml Peak Pressure + 5 cm H PEEP / CPAP + 2 cm H + 5%  Specificity - effect of one control on another Respiratory Rate - if tidal volume is constant, + 5% Tidal Volume + 5% Peak Pressure + 5%...
Page 57: Environmental And Physical Characteristics
Environmental and Physical Characteristics  MRI Conditional. Tested with a scanner up to: Maximum static field strength - 3 T 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) ...
Page 58 pNeuton Ventilator 10 - 4...
Page 59: Section 11. Limited Warranty
The official AIRON 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.
Page 60 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.
Page 61: Section 12. Index
Section 12: Index Accessories 6-1 Administering Oxygen 7-6 Airway Connection Port 3-3 Alarms High Pressure 3-5 Low Gas Supply 3-6, 7-11, 10-2 Patient Disconnect 3-7, 4-5, 7-10, 10-2 Altitude Operation 2-4, 4-5 Anti-Suffocation System 3-6 Cautions 2-3 Circuit, Patient Breathing Cleaning 9-1 Configuration 5-1 Connecting 5-2...
Page 62 Relationship to PEEP / CPAP System 7-6 Front Panel 3-1 High Altitude Operation 4-5 High Pressure Alarm 3-7 Hyperbaric Operation 2-2 Hypobaric Operation 4-5 Indications For Use 2-6 Internal Patient Safety Systems 3-6 Interrelationship Between Volume & Rate Controls 4-4, 7-3 Low Gas Supply Alarm 3-6, 7-11 Maintenance - Ventilator Service 9-1 Mandatory Breaths...
Page 63 Tank, Expected Operating Time 7-7 Patient Circuit Cleaning 9-1 Configuration 5-1 Connecting 5-2 Disconnect Alarm 3-7, 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 3-6 Power Requirements - Driving Gas Supply 10-3...
Page 64 Safety Systems 3-6 Sensitivity 7-6 Set Up 4-1 Service, Preventative 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 Tidal Volume Control 3-2 Interrelationship Between Volume &...