Care Fusion AVEA User manual

AVEA®ventilator systems
Operator’s manual

ii Operator's manual
L2786 Rev. M
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 CareFusion. Information in this
document is subject to change without notice.
This document is for informational purposes only and should not be considered as
replacing or supplementing the terms and conditions of the License Agreement.
© 2010–2011 CareFusion Corporation or one of its subsidiaries. All rights reserved. Avea
is a registered trademark of CareFusion Corporation or one of its subsidiaries. All other
trademarks are property of their respective owners.
USA
CareFusion
22745 Savi Ranch Parkway
Yorba Linda, California 92887-4668
USA
Authorized European Representative
CareFusion Germany 234 GmbH
Leibnizstrasse 7
97204 Hoechberg
Germany
800.231.2466 tel
+1.714.283.2228 tel
+49.931.4972.0 tel
+49.931.4972.423 fax
carefusion.com
Literature number: L2786 Revision M

AVEA ventilator systems iii
L2786 Rev. M
Revision History
Date
Revision
Changes
September 2005
A
Release
May 2006 B Removed references to the Plus model
Removed “non-operational” from figure 2-19
Added a note regarding the setting of Peak Inspiratory Pressure
Added Ppeak to the list of alert messages
December 2006 C Updated the Primary Controls table
Added NCPAP to the troubleshooting table
Updated the Rate specification
Added the chapter “Infant NCPAP”
February 2007 D Updated the figure and added a description of the balloon size and type selection
Added a note regarding the date and time
Added Addendums Filter/Water Trap, Processing Instructions, Sterilization, L2860-101, L3004A,
L3082A, L2889A, L3031A
September, 2008
E
Release of Volumetric Capnography
February 2010
F
Revised the manual to comply with the revised Medical Device Directive 2007/42/EC.
February 2010
G
Rebranded to the CareFusion style.
June 2010 H Revised the Circuit Resistance Test regarding the use of ET tubes.
Added a bullet under Warnings: Routine assessment of oxygenation and ventilation should be
performed when a patient is receiving respiratory support.
January 2011
J
Changed the logo and company references to VIASYS.
January 2011
K
Changed the logo and company references to CareFusion.
June 2011
L
Added content for Volume Guarantee and Nasal Intermittent Mandatory Ventilation.
July 2011
M
Removed the first note from the section “Specific Controls” regarding the flow cycling of breaths.

iv Operator's manual
L2786 Rev. M
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 CareFusion (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, 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.

AVEA ventilator systems v
L2786 Rev. M
Contents
Chapter 1: Introduction .................................................................................................................1
Chapter 2: Unpacking & Setup .....................................................................................................7
Ventilator Assembly & Physical Setup ....................................................................................................7
Setting Up the Front of the Ventilator......................................................................................................9
Front Panel Connections ......................................................................................................................17
Setting Up the Rear of the Ventilator ....................................................................................................24
User Verification Test............................................................................................................................39
AVEA User Verification Test Checklist..................................................................................................45
AVEA Troubleshooting..........................................................................................................................46
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
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.................................................................................................................................................170
Alarm Controls ....................................................................................................................................171
Alarm Types........................................................................................................................................172
Nasal CPAP / Nasal IMV Alarms ........................................................................................................181
Volume Guarantee Alarms..................................................................................................................184
Chapter 8: Maintenance and Cleaning.....................................................................................187
Cleaning and Sterilization ...................................................................................................................187
Recommended Periodic Maintenance ................................................................................................190
Battery Care........................................................................................................................................191
Fuses..................................................................................................................................................194

vi Operator's manual
L2786 Rev. M
Appendix A: Contact & Ordering Information............................................................................ 197
How to Call for Service....................................................................................................................... 197
Ordering Parts .................................................................................................................................... 198
Appendix B: Specifications ......................................................................................................... 201
Pneumatic Supply............................................................................................................................... 201
Electrical Supply................................................................................................................................. 201
Data Input / Output ............................................................................................................................. 202
Atmospheric & Environmental Specifications ..................................................................................... 208
Physical Dimensions .......................................................................................................................... 209
Accessories ........................................................................................................................................ 209
Appendix C: Pneumatic Diagram ................................................................................................ 211
Appendix D: Monitor Ranges and Accuracies ........................................................................... 213
Appendix E: Sensor Specifications & Circuit Resistance......................................................... 217
VarFlex®Sensor Specifications.......................................................................................................... 217
Hot Wire Flow Sensor Specifications ................................................................................................. 218
Circuit Resistance Test....................................................................................................................... 219
Volumetric Capnography Specifications............................................................................................. 220
Appendix F: AVEA Message Bar Text ........................................................................................ 221
Appendix G: Advanced Pulmonary Mechanics Monitored Parameters ................................... 223
Appendix H: Capnometry Troubleshooting................................................................................ 231
Appendix I: Volumetric CO2Calculations ................................................................................. 233
Appendix J: Electromagnetic Declarations ............................................................................... 237
Appendix K: Glossary .................................................................................................................. 241

AVEA ventilator systems vii
L2786 Rev. M
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 2601-1.
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.

viii Operator's manual
L2786 Rev. M
Classification
Type of Equipment: Medical Equipment, Class 1 type B
Adult/Pediatric/Infant Lung Ventilator
Declaration of Conformity Notice
This medical equipment complies with the Medical Device Directive, 93/42/EEC,
and the following Technical Standards, to which Conformity is declared:
BS EN 60601-2-12:2006
EN 60601-1
EN 60601-1-2
ISO 13485
UL 60601-1
CAN / CSA C22.2 No. 601.1.12-94 (R99)
EU Notified Body:
BSI (Reg. No. 0086)
Trade names:
AVEA ventilator systems
Manufactured by:
CareFusion
22745 Savi Ranch Parkway
Yorba Linda, California 92887-4668
USA
If you have a question regarding the Declaration of Conformity for this product, please contact CareFusion at one of the
numbers given in Appendix A.

AVEA ventilator systems ix
L2786 Rev. M
Safety Information
Please review the following safety information prior to 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 & 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 in order 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 FIO2and 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.
•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.

xOperator's manual
L2786 Rev. M
•Electric shock hazard - Do not remove any of the ventilator covers or panels. Refer all servicing to an authorized
CareFusion 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 per applicable
standards (UL2601 and IEC60601-1). However, this cannot be guaranteed when external devices are attached to the
ventilator. In order 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.
•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.
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/IEC601/UL2601.
•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.