Vyaire Avea Series Operators Manual Ver A Oct 2019

Avea™ Ventilator Series Operator’s Manual

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This document is protected by United States and international copyright laws. This document may not be copied, reproduced, translated, stored in a retrieval system, transmitted in any form, or reduced to any electronic medium or machine-readable form, in whole or in part, without the written permission of Vyaire Medical, Inc. Information in this document is subject to change without notice. This document is only for informational purposes and does not replace nor supplement the terms and conditions of the License Agreement. © 2019 Vyaire. Vyaire, the Vyaire logo, and Avea are trademarks or registered trademarks of Vyaire Medical, Inc., or one of its affiliates. Vyaire Medical 26125 North Riverwoods Blvd. Mettawa, IL 60045 USA vyaire.com Customer and Clinical Support Product, Accessories, and Parts Ordering 1-833-327-3284 [email protected]

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Warranty THE Avea™ ventilator systems are warranted to be free from defects in material and workmanship and to meet the published specifications for Two (2) years or 16,000 hours, whichever occurs first. The liability of Vyaire Medical (referred to as the Company) under this warranty is limited to replacing, repairing or issuing credit, at the discretion of the Company, for parts that become defective or fail to meet published specifications during the warranty period; the Company will not be liable under this warranty unless (A) the Company is promptly notified in writing by Buyer upon discovery of defects or failure to meet published specifications; (B) the defective unit or part is returned to the Company, transportation charges prepaid by Buyer; (C) the defective unit or part is received by the Company for adjustment no later than four weeks following the last day of the warranty period; and (D) the Company’s examination of such unit or part shall disclose, to its satisfaction, that such defects or failures have not been caused by misuse, neglect, improper installation, unauthorized repair, alteration or accident. Any authorization of the Company for repair or alteration by the Buyer must be in writing to prevent voiding the warranty. In no event shall the Company be liable to the Buyer for loss of profits, loss of use, consequential damage or damages of any kind based upon a claim for breach of warranty, other than the purchase price of any defective product covered hereunder. The Company warranties as herein and above set forth shall not be enlarged, diminished or affected by, and no obligation or liability shall arise or grow out of the rendering of technical advice or service by the Company or its agents in connection with the Buyer's order of the products furnished hereunder.

Limitation of Liabilities This warranty does not cover normal maintenance such as cleaning, adjustment or lubrication and updating of equipment parts. This warranty shall be void and shall not apply if the equipment is used with accessories or parts not manufactured by the Company or authorized for use in writing by the Company or if the equipment is not maintained in accordance with the prescribed schedule of maintenance. The warranty stated above shall extend for a period of TWO (2) years from date of shipment or 16,000 hours of use, whichever occurs first, with the following exceptions: 1.

Components for monitoring of physical variables such as temperature, pressure, oxygen, or flow are warranted for ninety (90) days from date of receipt.

2.

Elastomeric components and other parts or components subject to deterioration, over which the Company has no control, are warranted for sixty (60) days from date of receipt.

3.

Internal batteries are warranted for ninety (90) days from the date of receipt.

The foregoing is in lieu of any warranty, expressed or implied, including, without limitation, any warranty of merchantability, except as to title, and can be amended only in writing by a duly authorized representative of the Company.

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Contents Notices vii EMC Notice ... vii MRI Notice ... vii Intended Use Notice ... vii Regulatory Notice ... vii Classification ... viii Safety Information ... viii Equipment Symbols ... xi Chapter 1: Introduction ...1 Some Avea™ Features...2 Chapter 2: Unpacking and Setup ...7 Ventilator Assembly and Physical Setup ...7 Setting Up the Front of the Ventilator ...9 Front Panel Connections ...17 (Comprehensive Model Only) ...23 Setting Up the Rear of the Ventilator ...24 User Verification Test...39 Avea™ User Verification Test Checklist ...46 Avea™ Troubleshooting ...47 Chapter 3: Ventilator Operation ...51 Membrane Buttons and LEDs ...51 Patient Setup ...59 Ventilation Setup ...61 Setting the Ventilation Breath Type and Mode ...66 Volume Guarantee (VG) ...67 Primary Breath Controls ...90 Advanced Settings ...96 Independent Lung Ventilation (ILV)...104 Chapter 4: Monitors, Displays and Maneuvers ...105 Graphic Displays ...105 Digital Displays ...124 Main Screen Displays ...130 Chapter 5: Volumetric Capnography ...133 Theory of Operation ...133 32523-001 Version A (2019-10)

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Setup ... 134 Settings and Monitored Values ... 137 Alarms ... 141 Maneuvers ... 142 Zeroing the CAPNOSTAT 5... 144 Checking the Accuracy of the CAPNOSTAT 5 ... 146 Chapter 6: Infant Non-invasive Ventilation ... 149 Nasal CPAP (nCPAP) ... 149 Nasal Intermittent Mandatory Ventilation (nIMV) ... 155 Chapter 7: Alarms and Indicators ... 167 Status Indicators ... 167 Messages ... 169 Alarms ... 171 Alarm Controls ... 172 Alarm Types ... 173 Nasal CPAP / Nasal IMV Alarms ... 182 Volume Guarantee Alarms ... 185 Chapter 8: Cleaning and Maintenance ... 187 Cleaning and Sterilization ... 187 Recommended Periodic Maintenance ... 191 Battery Care ... 192 Fuses ... 195 Appendix A: Contact and Ordering Information ... 199 How to Call for Service ... 199 Appendix B: Specifications ... 201 Pneumatic Supply... 201 Electrical Supply ... 201 Data Input / Output ... 202 Digital Communication ... 205 VOXP Communications Requirements... 208 Language Support ... 208 Atmospheric and Environmental Specifications ... 209 Physical Dimensions ... 209 Accessories ... 209 Appendix C: Pneumatic Diagram ... 211

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Appendix D: Monitor Ranges and Accuracies ...213 Appendix E: Sensor and Circuit Specifications ...217 VarFlex® Sensor Specifications ...217 Hot Wire Flow Sensor Specifications ...218 Circuit Resistance Test ...219 Circuit Compatibility ...219 Volumetric Capnography Specifications ...220 Appendix F: Tracheal Monitoring Tube Compatibility...221 Appendix G: Avea™ Message Bar Text ...223 Appendix H: Advanced Pulmonary Mechanics Monitored Parameters ...225 Appendix I: Capnometry Troubleshooting...233 Appendix J: Volumetric CO2 Calculations ...235 Appendix K: Electromagnetic Declarations ...239 Appendix L: Glossary...243 Appendix M: Index ...245

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Notices EMC Notice This equipment generates, uses, and can radiate radio frequency (RF) energy. If this equipment is not installed and used in accordance with the instructions in this manual, electromagnetic interference may result. This equipment has been tested and found to comply with the limits of acceptance set forth in Standard EN 60601-1-2 for Medical Products. These limits provide reasonable protection against electromagnetic interference (EMC) when operated in the intended use environments described in this manual. This ventilator is also designed and manufactured to comply with the safety requirements of Standard EN 60601-1, IEC 60601-2-12, CAN/CSA-C22.2 No. 601.1-M90, and UL 60601-1-1. This ventilator can be affected by portable and mobile RF communications equipment. This ventilator should not be stacked with other equipment. The following cables were used in the evaluation of this ventilator. •

15619 – Normally Open Patient Call Cable (Length – 1.7 meters)

•

15620 – Normally Closed Patient Call Cable (Length – 1.7 meters)

•

70600 – Cable, Communications (Length – 1 meter)

•

70693 – Cable, Communications (Length – 3 meters)

•

Standard Centronics Printer Cable (Length – 2 meters)

•

Standard SVGA Monitor Cable (Length – 2 meters)

Use of other cables may result in increased emissions or decreased immunity. See Tables 201, 202, 203, and 205 for further information regarding the Avea Ventilator and EMC.

MRI Notice This equipment contains electromagnetic components whose operation can be affected by intense electromagnetic fields. Do not operate the ventilator in a MRI environment or in the vicinity of high-frequency surgical diathermy equipment, defibrillators, or short-wave therapy equipment. Electromagnetic interference could disrupt the operation of the ventilator.

Intended Use Notice The Avea is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician.

Regulatory Notice Federal law restricts the sale of this device except by or on order of a physician. The benefit of treatment with medical respiratory support devices outweighs the remote possibility of exposure to phthalates.

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Classification Type of Equipment:

Safety Information

Medical Equipment, Class 1 type B Adult/Pediatric/Infant Lung Ventilator

Please review the following safety information before operating the ventilator. Attempting to operate the ventilator without fully understanding its features and functions may result in unsafe operating conditions. Warnings and Cautions, which are general to the use of the ventilator under all circumstances, are included in this section. Some Warnings and Cautions are also inserted within the manual where they are most meaningful. Notes are also located throughout the manual to provide additional information related to specific features. If you have a question regarding the installation, set up, operation, or maintenance of the ventilator, contact Customer Care, as shown in Appendix A Contact and Ordering Information.

Terms WARNINGS

identify conditions or practices that could result in serious adverse reactions or potential safety hazards.

CAUTIONS

identify conditions or practices that could result in damage to the ventilator or other equipment.

NOTES

identify supplemental information to help you better understand how the ventilator works.

Warnings Warnings and Cautions appear throughout this manual where they are relevant. The Warnings and Cautions listed here apply generally any time you operate the ventilator. •

The Avea Ventilator is intended for use by a trained practitioner, under the direction of a qualified physician.

•

When the ventilator is connected to a patient, a trained health care professional should be in attendance at all times to react to an alarm or other indications of a problem.

•

Alarm loudness must be set above ambient sound for the alarm to be heard.

•

Always have an alternate means of ventilation available whenever the ventilator is in use.

•

The operator should not touch the electrical connectors of the ventilator or accessories, and the patient simultaneously.

•

Due to possible explosion hazard, the ventilator should not be used in the presence of flammable anesthetics.

•

An audible alarm indicates an anomalous condition and should never go unheeded.

•

Anti-static or electrically conductive hoses or tubing should not be used within the patient circuit.

•

If a mechanical or electrical problem is recognized while operating the ventilator, the ventilator must be removed from use and referred to qualified personnel for servicing. Using an inoperative ventilator may result in patient injury.

•

When a low gas supply alarm occurs, the oxygen concentration delivered to the patient will differ from that set on the O2 control setting.

•

A source gas failure will change the FIO2 and may result in patient injury.

•

The functioning of this equipment may be adversely affected by the operation of other equipment nearby, such as high frequency surgical (diathermy) equipment, defibrillators, short-wave therapy equipment, “walkie-talkies,” or cellular phones.

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Water in the air supply can cause malfunction of this equipment.

•

Do not block or restrict the Oxygen bleed port located on the instrument back panel. Equipment malfunction may result.

•

Electric shock hazard - Do not remove any of the ventilator covers or panels. Refer all servicing to an authorized Vyaire Medical service technician.

•

A protective ground connection by way of the grounding conductor in the power cord is essential for safe operation. Upon loss of protective ground, all conductive parts including knobs and controls that may appear to be insulated can render an electric shock. To avoid electrical shock, plug the power cord into a properly wired receptacle, use only the power cord supplied with the ventilator, and make sure the power cord is in good condition.

•

The Avea is designed to ensure that the user and patient are not exposed to excessive leakage current according to applicable standards (UL 60601-1 and IEC60601-1). However, this cannot be guaranteed when external devices are attached to the ventilator. To prevent the risk of excessive enclosure leakage current from external equipment attached to the RS-232, printer and video ports, isolation of the protective earth paths must be provided to ensure proper connection. This isolation should ensure that the cable shields are isolated at the peripheral end of the cable. Only IEC 60950-1 or IEC 60601-1 certified external peripheral equipment shall be attached to the device.

•

Routine assessment of oxygenation and ventilation should be performed when a patient is receiving respiratory support.

•

Delivered and monitored flow as well as pressure and volume settings and values are subject to device accuracy specifications as described herein.

•

To avoid a potential safety hazard when operating two or more of the same or similar device in a single area, use the same audible alarm characteristics.

Cautions The following cautions apply any time you work with the ventilator. •

Ensure that the voltage selection and installed fuses are set to match the voltage of the wall outlet, or damage may result.

•

A battery that is fully drained (i.e. void of any charge) may cause damage to the ventilator and should be replaced.

•

All accessory equipment that is connected to the ventilator should comply with CSA/IEC 60601-1/UL 60601-1.

•

To avoid damage to the equipment, clean the air filter regularly.

The following cautions apply when cleaning the ventilator or when sterilizing ventilator accessories. •

Do not sterilize the ventilator. The internal components are not compatible with sterilization techniques.

•

Do not gas sterilize or steam autoclave tubing adapters or connectors in place. The tubing will, over time, take the shape of the adapter, causing poor connection and possible leaks.

•

DO NOT submerge the ventilator or pour cleaning liquids over or into the ventilator.

•

The patient-specific settings for the ventilator are stored in non-volatile memory every minute during use or each time a setting is changed. This allows indefinite recovery of the settings even in the event of total power loss. Exceptions would be any time the New Patient function is selected before ventilation or intentional clearing of the memory, such as installing new software.

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•

When the recommended breathing system is in use, and normal ventilation is compromised, resulting in the opening of the safety valve, the inspiratory and expiratory gradient at the patient-connection port shall not be greater than shown below: 5 LPM

30 LPM

60 LPM

Inspiratory

0.7 cmH2O

2.1 cmH2O

5.0 cmH2O

Expiratory

0.7 cmH2O

3.8 cmH2O

5.3 cmH2O

The use of any attachments or accessories placed in the breathing systems (circuit) may increase the pressure gradient across the breathing system (resistance) for the patient.

NOTE

Maximum Circuit Pressure Limit: The ventilator has an independent mechanical pressure relief valve that limits the maximum pressure at the patient wye to 125 cmH2O. Safety Valve: Under certain conditions, the safety valve automatically opens, which gives the patient the ability to spontaneously breathe without having to draw a sub-ambient pressure to open the valve. Under this condition, the exhalation valve is also de-energized and allows one-way breathing through the circuit to prevent the re-breathing of exhaled gases.

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Equipment Symbols

The following symbols may be referenced on the ventilator or in accompanying documentation Symbol

Source/Compliance ISO 7010-W001

General warning

ISO 7000-0434A

Caution

Symbol #5016 IEC 60417

This symbol indicates a FUSE.

Symbol #5034 IEC 60417 Symbol #01-36 IEC 60878 Symbol #5035 IEC 60417 Symbol #01-37 IEC 60878 Symbol #5031 IEC 60417 Symbol #5019 IEC 60417 Symbol #01-20 IEC 60878 Symbol #5021 IEC 60417 Symbol # 01-24 IEC 60878

Symbol # 5333 IEC 60417 Symbol #02-03 IEC 60878 Symbol #5032 IEC 60417

ACCEPT

Meaning

This symbol indicates INPUT. This symbol indicates OUTPUT This symbol indicates DIRECT CURRENT (DC) This symbol indicates protective EARTH (ground). This symbol indicates the EQUIPOTENTIAL connection used to connect various parts of the equipment or of a system to the same potential, not necessarily being the earth (ground) potential (e.g., for local bonding). This symbol indicates TYPE B equipment, which indicates equipment that provides a particular degree of protection against electric shock, particularly with regards to allowable leakage current and reliability of the protective earth connection.

Symbol #01-14 IEC 30878

This symbol is located on the rating plate. It indicates the equipment is suitable for alternating current.

Symbol #5007 IEC 60417 Symbol #01-01 IEC 60878

Indicates ON (Power)

Symbol #5008 IEC 60417 Symbol #01-02 IEC 60878

Indicates OFF (Power)

Symbol #0651 ISO 7000

Horizontal return with line feed. Indicates ACCEPT entered values for a specific field.

Vyaire Medical Symbol

Indicates PATIENT EFFORT

Vyaire Medical Respiratory Care symbol

Indicates MANUAL BREATH

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Symbol

CANCEL

Source/Compliance

Meaning

Vyaire Medical Symbol

MAIN SCREEN

Symbol #417 IEC 5102

EVENT READY

Vyaire Medical Symbol

MODE

Vyaire Medical Symbol

ADVANCED SETTINGS

Vyaire Medical Symbol

SET-UP for patient size selection

Symbol #5307 IEC 60417

ALARM RESET

Symbol #5319 IEC 60417

ALARM SILENCE

Vyaire Medical symbol

ADULT patient

Vyaire Medical symbol

PEDIATRIC patient

Vyaire Medical symbol

NEONATAL (Infant) patient

Graphical Symbol in general use internationally for “DO NOT”

CANCEL, i.e. do not accept entered values.

Vyaire Medical symbol

Select DISPLAYED SCREEN function.

Symbol 5467 IEC 60417

FREEZE the current display.

Vyaire Medical symbol

Enable the ALARM LIMITS screen

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Symbol

Source/Compliance

Meaning

Vyaire Medical symbol

This symbol indicates a CONTROL LOCK.

Vyaire Medical symbol

NEBULIZER port

Vyaire Medical symbol

Increase OXYGEN

Vyaire Medical symbol

PRINT SCREEN

Vyaire Medical symbol

SUCTION port

Vyaire Medical symbol

VARIABLE ORIFICE FLOW SENSOR connection

Vyaire Medical symbol

HOT WIRE FLOW SENSOR connection

Vyaire Medical symbol

ANALOG IN/OUT connection

Vyaire Medical symbol

Display the MAIN SCREEN

Vyaire Medical symbol

DO NOT BLOCK PORT

Vyaire Medical symbol

EXTERNAL BATTERY connection

Vyaire Medical symbol

Indicates GAS ID port

Vyaire Medical symbol

OXYGEN SENSOR connection

Vyaire Medical symbol

OVERPRESSURE relief

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Symbol

Source/Compliance

Meaning

Vyaire Medical symbol

REMOTE NURSE CALL connection

Vyaire Medical symbol

USER INTERFACE MONITOR connection

Vyaire Medical symbol

This symbol indicates an INTERNAL BATTERY FUSE

Vyaire Medical symbol

This symbol indicates ALARM LOUDNESS

Vyaire Medical symbol

This symbol indicates that the Avea is being powered by the INTERNAL BATTERY only.

Vyaire Medical symbol

This symbol indicates that the HELIOX configuration is in use.

Vyaire Medical symbol

This symbol indicates the product contains phthalates.

Symbol #0434 IEC TR60878

Indicates ATTENTION or CAUTION

Manufacturer

Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC

Medical device

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Chapter 1: Introduction The Avea is a fourth generation, servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for neonatal through adult patients. Its revolutionary user interface module (UIM) provides maximum flexibility with simple operator interaction. It has a flat panel color LCD with real time graphic displays and digital monitoring capabilities, a touch screen for easy interaction, membrane keys and a dial for changing settings and operating parameters. A precision gas delivery engine with servo controlled active inhalation and exhalation improves performance over previous generations. The Avea has been designed to function using most commonly available accessories. It is easy to clean and its design does not allow liquids to pool on the casing, reducing the likelihood of fluid leakage into the body of the ventilator. There are two models of Avea: Comprehensive and Standard. The following table shows the standard and optional functions available with each model.

Functions and Accessories Modes

Standard

Comprehensive

All

All

Proximal Hot Wire Flow Sensing Synchronized Nebulizer 24 Hour Trending Internal Battery Full Color Graphics Display Loops and Waveforms Standard Cart Proximal Variable Orifice flow sensing Proximal Airway Pressure Monitoring Tracheal Monitoring Tube Esophageal Balloon Internal Compressor Heliox Delivery

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Optional Functions and Accessories

Standard

Comprehensive

Custom Cart

Option

Included

External Battery (on custom cart only)

Option

Option

Gas Tank Holder (on either cart)

Option

Option

Internal Compressor

Option

Included

Pflex Maneuver

Option

Included

Heliox Delivery

Option

Included

nIMV/ Volume Guarantee

Option

Included

Volumetric Capnography

Option

Option

Some Avea™ Features Artificial Airway Compensation1 When Artificial Airway Compensation is turned on, the ventilator automatically calculates the pressure drop across the endotracheal tube. The Avea then adjusts the airway pressure to deliver the set inspiratory pressure to the distal (carina) end of the endotracheal tube. This calculation takes into account flow, gas composition (Heliox or Nitrogen/Oxygen), Fraction of Inspired Oxygen (FIO2), tube diameter, length, and pharyngeal curvature based on patient size (Neonatal, Pediatric, Adult). This compensation only occurs during inspiration. Artificial Airway Compensation is active in all Pressure Support and Flow Cycled Pressure Control Breaths.

WARNING

Activating of Artificial Airway Compensation while ventilating a patient will cause a sudden increase in the peak airway pressures and a resultant increase in tidal volume. If you choose to activate Artificial Airway Compensation while the patient is attached to the ventilator you will need to exercise caution to minimize the risk of excessive tidal volume delivery.

NOTE

Monitored airway pressures (inspiratory) will be higher than set values when Artificial Airway Compensation is active. With an inspiratory pressure setting of zero, Artificial Airway Compensation will still provide an elevated airway pressure, which will compensate for the resistance of the endotracheal tube. When turned on the Artificial Airway Compensation indicator will appear in all modes of ventilation even though the function may not be active (i.e.: Volume Controlled Breaths). This is to alert you to the fact that Artificial Airway Compensation will become active if a Pressure Support or combination mode (e.g. Volume Control SIMV) is selected. Range:

Off/On

Default:

Off

Available in all patient sizes

1

Estimation of Inspiratory Pressure Drop in Neonatal and Pediatric Endotracheal Tubes, by Perre-Henri Jarreau, American Physiological Society 1999

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Full range of Patient Size You can select a patient size of Adult, Pediatric, or Neonate. Once the selection is made, the ventilator offers only those parameters, which are available for your selected patient size. For a complete listing of compatible circuits and accessories, see “Appendix E: Sensor and Circuit Specifications” on page 217.

Non-Invasive Ventilation The ventilator can perform non-invasive ventilation with a standard dual limb circuit. Leak compensation should be turned on when using this feature. To turn leak compensation on, use the touch screen control displayed in the Ventilator Set-Up Screen.

NOTE

Noninvasive ventilation requires the use of a snug fitting mask with no bleed holes. Excessive leaks around the mask may result in false triggering of the ventilator or assertion of disconnect alarms.

Leak Compensation Leak Compensation is used to compensate for baseline leaks, which may occur at the patient mask interface or around the patient’s endotracheal tube. It only provides baseline leak compensation and is not active during breath delivery. During exhalation, PEEP is maintained by the cooperation of the Flow Control Valve (FCV) and the Exhalation Valve (ExV). The ExV pressure servo is set to a target pressure of PEEP and the FCV pressure servo is set to a pressure target of PEEP - 0.4 cmH2O. The ExV servo relieves when the pressure is above its target and the FCV supplies flow when the pressure drops below its target up to a maximum flow rate for the patient size Range:

Off/On

Default:

Off

Circuit Compliance Compensation When Circuit Compliance is active, the volume of gas delivered during a volume controlled or targeted breath is increased to include the set volume, plus the volume lost due to the compliance effect of the circuit. Circuit Compliance is active for the set Tidal Volume during volume control ventilation, the Target Tidal Volume in PRVC mode and for Machine Volume. It is only active in Adult and Pediatric applications. Exhaled volume monitors for all modes and breath types are also adjusted for the compliance compensation volume. Range:

0.0 to 7.5 ml/cmH2O

Default:

0.0 ml/cmH2O

The ventilator automatically measures Circuit Compliance during the Extended Systems Test (EST). The value cannot be entered manually.

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NOTE

Although circuit compliance is displayed on the Setup screen it is not active for neonatal patients. High circuit compliance with small tidal volumes may result in extended inspiratory times. This is a result of the delivery of the circuit compliance volume at the set flow rate. Setting extremely small delivered tidal volumes with Circuit Compliance Compensation not active and using a proximal flow sensor may result in assertion of Patient Circuit Disconnect Alarms.

Humidification You can select active or passive humidification (ON/active or OFF/passive). Active humidification assumes 99% RH; passive assumes 60% RH when using an HME. This feature adjusts the BTPS correction factor to correct exhaled tidal volumes. Range: Default:

Off/On Active (ON)

NOTE

Incorrect setting of the Humidification feature will affect monitored exhaled volume accuracy.

Heliox Delivery (Comprehensive only, option on Standard) Using patented “Smart” connector technology, the Comprehensive model Avea can deliver Heliox blended gas instead of Medical air. By simply changing a connector on the back panel, the ventilator identifies the gas input and adjusts to accommodate the change. All volumes (numeric and graphic) are automatically compensated for accurate display. The clinical benefits of helium / oxygen gas are based on its significantly lower gas density when compared to nitrogen / oxygen gas. This lower gas density allows the same volumetric (tidal volume) of gas to be delivered to the patient at a significantly lower airway pressure. Additionally, the low-density properties of the gas allow it to diffuse past airway obstructions or restrictions much easier than nitrogen / oxygen gas mixtures.

NOTE

The Heliox “smart” connector is designed for use with an 80/20 Heliox tank only. Only a mixture of 20% oxygen and 80% Helium can be used as the Heliox gas supply. If Heliox gas is connected this green icon displays in bottom right of the touch screen. To set the Helium / Oxygen mixture during administration simply set the desired FIO2, the balance of the breathing gas is Helium. For example: A set FIO2 of 35% will deliver a 65/35 Heliox mixture to the patient.

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WARNING

Connection of a gas supply at the Helium-Oxygen mixture inlet that does not contain 20% oxygen can cause hypoxia or death. Although an 80/20 mixture of Helium and Oxygen is marketed as medical gas, the Helium/Oxygen gas mixture is not labeled for any specific medical use.

NOTE

Hot wire flow sensors will not function with Heliox gas mixtures. During Heliox delivery, a variable orifice flow sensor should be used for monitoring delivered volumes at the proximal airway.

NOTE

Heated humidifier performance should be carefully monitored during Heliox therapy. Helium has significantly greater thermal conductivity compared to nitrogen / oxygen gas mixtures and this could cause difficulty with some heated humidification devices. A febrile patient may transfer heat via the gas column to a proximal temperature sensor, which could affect the duty cycle of the humidifier and decrease output. This could cause desiccation of secretions in the airway. Alternately, in applications where a heated wire breathing circuit is used, this heat transfer from the patient may affect the duty cycle of the heated wire circuit, which may result in increased condensation in the breathing circuit. The relative settings of some types of humidifiers may need to be reduced to prevent overheating of the breathing gas.

NOTE

The Oxygen alarm cannot be disabled during Heliox administration Do not operate nebulizer while using heliox

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