CareFusion Avea Ventilator System Service Manual Rev D

Avea® ventilator system

Service Manual

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 CareFusion Corporation or one of its subsidiaries. All rights reserved. Avea ventilator system 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

Authorized European Representative CareFusion Germany 234 GmbH Leibnizstrasse 7 97204 Hoechberg, Germany District Court Wuerzburg HRB7004

800.231.2466 tel +1.714.283.2228 tel +1.714.283.8493 fax

+49.931.4972.0 tel +49.931.4972.423 fax

carefusion.com

Literature number: L1524 Revision D

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Revision History Date

Revision

Changes

August 2002

A

Released Engineering Document Control ECO

July 2003

B

Add Exception button and Exception screen to Error Log screen. Add list of error codes. Add OVP kits and instructions. Add Software upgrade instructions. Add heliox Smart connector instructions. Add Compressor upgrade instructions. Add cart instructions (both). Add external battery pack instructions. Add Insp and Exp transducer Cal instructions. Add ref to Communications Protocol. Add unpacking and setup instructions. Reorganize chapters, add chapter 3, add chapter 5 (OVP), add software upgrade info (chapter 6), add chapter 9, add chapter 10, add appendix D.

January 2006

C

Updated the company name. Added external batteries to the Limitation of Liability. Added symbols for the battery and for HeOx. Updated the General Description. Changed the references of the Tracheal Catheter and the Esophageal Balloon. Changed “O2 bottle” to “O2 tank.” Changed the Monitor MCU description. Updated the description of the power supply system and the Transducer / Alarm PCB. Updated the description of the heated expiratory system. Updated the standard-stand carton contents table. Updated the procedure for setting up the Customer Transport Cart kit. Updated figures. Added part number references to “E Cylinder Bracket Assembly Instructions.” Added Pediatric Patient Circuit to the list of equipment. Removed the note regarding the UIM. Replaced the word “arm” with “neck.” Removed the note regarding the UIM. Added a note regarding the screws to the Metal Top Cover section. Updated the Gas Delivery Engine Removal procedure. Updated the fuse specifications. Updated the Compressor /Scroll Pump section. Changed the part number of the Enhanced Patient Monitor board. Added the fan assembly and power supply part numbers. Added part numbers to step 1 of the removal procedure. Changed step 5 of the Installation procedure to include the part number. Added references to PSI to the Setup procedure.

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Date

Revision

Changes Updated the Manual Alarms Testing section. Added two steps to the Testing Guidelines section. Added step 22 to the Membrane Switch test. Op. Verification Checklist Updated the Checkout Sheet. Replaced figure A-1 Updated the MIB Connection section. Added the Blender Bleed section. Added the Sound Levels section. Updated the Water Trap section. Updated the Message Bar Text table. Added the Monitor Ranges and Accuracies table. Added the Sensor Specifications and Circuit Resistance table. Added the Hot Wire Flow Sensor Specifications table. Added the Circuit Resistance section.

March 2010

iv

D

Clarified component removal directions (compressor, fan, power supply). Corrected the heater removal/assembly instructions. Clarified the OVP tests. Clarified VT accuracy verification directions. Corrected the battery-charge indicator specifications. Added Battery Performance Verification to the OVP checklist. Clarified the software upgrade instructions. Added the Coldfire service screens. Clarified the transducer screens. Clarified the Flow Characteristic Test. Clarified the Exhalation Valve Characteristics Test. Added instructions for removing the O2 sensor. Corrected the battery specifications. Added the Coldfire UIM to Digital Communication. Labeled the internal battery fuse on the rear panel diagram. Removed software descriptions. Added barometric pressure for the Coldfire UIM. Added EtCO2 parameters to “Monitor Ranges and Accuracy” in the appendix. Added EtCO2, OVP, GDE, and EPM to the glossary. Added “component removal” and “components of OVP” to the index. Clarified the Compressor test in OVP.

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Notices EMC Notice This equipment generates, uses, and can radiate radio frequency energy. If not installed and used in accordance with the instructions in this manual, electromagnetic interference may result. The equipment has been tested and found to comply with the limits set forth in EN60601-1-2 for Medical Products. These limits provide reasonable protection against electromagnetic interference when operated in the intended use environments described in this manual. The ventilator has been tested to conform to the following specifications: MIL-STD-461D:1993, MIL-STD-462D:1993, EN55011:1991, IEC 1000-4-2:1994, IEC 1000-43:1994, IEC 1000-4-4:1994, IEC 1000-4-5:1994, QUASI-STATIC:1993 This ventilator is also designed and manufactured to comply with the safety requirements of IEC 601-1, IEC 601-2-12, CAN/CSA-C22.2 No. 601.1-M90, and UL 2601-1.

MRI Notice This equipment contains electromagnetic components whose operation can be affected by intense electromagnetic fields. Do not operate the ventilator in an 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 Ventilators are designed to provide ventilator support for the critical care management of infant, pediatric or adult patients with compromised lung function. They are intended to provide continuous respiratory support in an institutional health care environment. They 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.

IEC Classification Type of Equipment:

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

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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: EN60601-1 EN60601-1-2 ISO 13485 EU Notified Body: BSI (Reg. No. 0086) Trade names: Avea Ventilator If you have a question regarding the Declaration of Conformity for this product, please contact CareFusion at the number given in Appendix A.

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.

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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: • Components for monitoring of physical variables such as temperature, pressure, or flow are warranted for ninety (90) days from date of receipt. • 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. • Internal batteries are warranted for ninety (90) days from the date of receipt. • External batteries are warranted for one (1) year 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 Revision History... iii Notices ... v Warranty ... vi Chapter 1 Introduction ... 1 Safety Information ... 1 Equipment Symbols ... 4 Chapter 2 Theory of Operation ... 9 General Description ... 9 High Level Design ... 11 Detail Design ... 13 Chapter 3 Installation Instructions... 23 Stand Assembly Instructions ... 23 External Battery Installation Procedures ... 30 Assembly Instructions for Comprehensive cart P/N 33976 (Metal cart)) ... 31 Assembly Instructions–Comprehensive Plastic Cart (P/N 11524) )) ... 36 “E” Cylinder Bracket Assembly Instructions ... 39 Assembly Instructions for Basic Stand Bracket... 40 Assembly Instructions–Comprehensive Metal and Plastic Stand Bracket ... 43 Avea Unpacking Instructions ... 44 Medical Gas Connector Kit Installation Instructions ... 47 Chapter 4 Assembly and Disassembly ... 49 General Instructions and Warnings ... 49 Recommended Tools and Equipment... 49 User Interface Module (UIM) ... 50 Exhalation Corner Assembly ... 51 Metal Top Cover ... 52 Gas Delivery Engine P/N 16222A ... 53 Ventilator Wheeled Base ... 59 Internal Batteries P/N 68339A ... 60 Fuses ... 61 Compressor/Scroll Pump P/N 51000-09750A ... 65 Enhanced Patient Monitor (EPM) Board P/N 51000-40848A ... 67 Fan ... 69 Power Supply P/N 16388 ... 70 Exhalation Valve P/N 16319 ... 72 Heater Assembly P/N 51000-40824 ... 75 Microswitch, Top Cover P/N 68294 ... 76 EMI Shield ... 76 Front Interface Panel P/N 51000-40635 ... 77 Bottom Cover ... 78 Alarm Speaker P/N 51000-40818 ... 79 Nebulizer Assembly P/N 51000-40026 ... 80 Accumulator P/N 51000-40748 ... 82 Secondary Alarm Installation (Kit P/N 16316) ... 83 Functional Testing of the Secondary Alarm Assembly ... 85 Additional Test to ensure Proper Wire Routing ... 85 Chapter 5 Operational Verification Procedure (OVP) ... 91 User Verification Tests (UVT) ... 91 Set up ... 92 User Interface Module (UIM) Verification ... 102 Compressor Check ... 104 Power Indicators and Charging Verification ... 105

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Battery Run Procedure ... 106 Battery Performance Verification ... 106 Air/Oxygen Inlet Pressure Verification ... 107 Breath Rate Verification ... 108 Blending Accuracy Verification... 108 PEEP Verification ... 108 Avea Assembly and Operational Verification Test Checklist ... 109 Chapter 6 Avea Software Upgrade ... 111 Coldfire Software Upgrade Directions ... 111 ELAN Software Upgrade Instructions ... 115 Software Install Verification Avea Ventilators ... 125 Installation Verification ... 125 Confirmation checks... 125 Verification and Calibration ... 126 Test and Access of the Security System... 127 Chapter 7 Calibration ... 131 Touch Screen Calibration Procedure ... 131 Transducer Calibrations ... 134 Calibration setup ... 135 Aux Pressure ... 141 Flow Valve Characterization Test ... 149 Hysteresis Test ... 152 Exhalation Valve Leak Test ... 153 Air-O2 Regulator Differential Balance Calibration... 154 CO2 Calibration Procedure ... 155 Chapter 8 Preventive Maintenance ... 161 Battery Discharge Procedure... 162 Replacing the O2 and Air/Heliox filters ... 163 Replacing the Compressor Inlet and Outlet filters ... 165 Replacing the Exhalation Diaphragm P/N 16240 ... 166 Replacing the O2 Sensor ... 169 Chapter 9 Troubleshooting ... 171 List of Possible Error Codes ... 173 Avea Mechanical Troubleshooting ... 175 Chapter 10 Parts List ... 185 Chapter 11 Appendices ... 191 Contact and Ordering Information ... 191 Diagrams and Schematics ... 192 Specifications ... 243 Avea Message Bar Text ... 252 Adjusting Barometric Pressure for Altitude ... 253 Monitor Ranges and Accuracies ... 255 Monitored Values ... 259 Sensor Specifications and Circuit Resistance ... 263 Hot Wire Flow Sensor Specifications ... 264 Circuit Resistance (per EN794 –1) ... 265 Advanced Pulmonary Mechanics Monitored Parameters ... 266 Glossary ... 272

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Chapter 1

Service Manual

Introduction

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 VASYS Respiratory Care 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.

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Warnings Warnings and Cautions appear throughout this manual where they are relevant. The Warnings and Cautions listed here apply generally any time you work on the ventilator. • Alarm loudness must be set above ambient sound in order to be heard. • 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 running the Operational Verification Tests, or while operating the ventilator, the ventilator must be removed from use until the problem has been identified and resolved. • 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. • Electric shock hazard – Ensure the ventilator is disconnected from the AC power supply before performing and repairs or maintenance. When you remove any of the ventilator cover panels, immediately disconnect the internal battery “quick release” connector before working on the ventilator. If the ventilator has an external battery installed, ensure that the external battery is unplugged from the rear panel before proceeding • 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 following warnings must be read and understood before performing the procedures described in this manual. • Under no circumstances should this medical device be operated in the presence of flammable anesthetics or other volatile materials due to a possible explosion hazard. • Liquid spilled or dripped into the unit may cause damage to the unit or result in an electrical shock hazard. • Oxygen vigorously accelerates combustion. To avoid violent ignition, do not use any gauges, valves, or other equipment that has been exposed to oil or grease contamination.

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• Do not use this device if any alarm/alert function is inoperative. To do so could result in a malfunction without warning, possibly resulting in personal injury, including death or property damage. • All tubing and fittings used to connect high pressure gas from the source to the test equipment and from the test equipment to the device being tested must be capable of withstanding a minimum supply pressure of 100 psi (7.03 kg/cm2). The use of tubing and fittings not capable of withstanding this pressure could cause the tubing to rupture, resulting in personal injury or property damage. • When verifying the operation of this medical device, do not breathe directly from the machine. Always use a fresh bacterial filter and test circuit. Failure to do so may constitute a hazard to the health of the service person. • If any of the procedures outlined in this document cannot be verified, do not use this device and refer it to CareFusion or a CareFusion authorized service facility or a CareFusion trained hospital service technician.

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 must 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, cause poor connection and possible leaks. • DO NOT submerge the ventilator or pour cleaning liquids over or into the ventilator. • Do not use MEK, Trichloroethylene or similar solutions as damage to surface may result. Do not allow any liquid to spill or drip into the ventilator. • Circuit boards are subject to damage by static electricity. Do not touch components, circuit, or connector fingers with hands. Handle only by edges.

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

Source/Compliance

Meaning

Symbol #03-02 IEC 60878

Indicates ATTENTION, consult ACCOMPANYING DOCUMENTS

Symbol #5016 IEC 60417

This symbol indicates a FUSE.

Symbol #5034 IEC 60417

This symbol indicates INPUT.

Symbol #01-36 IEC 60878 Symbol #5035 IEC 60417

This symbol indicates OUTPUT

Symbol #01-37 IEC 60878 Symbol #5019 IEC 60417

This symbol indicates protective EARTH (ground).

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 Symbol #01-14 IEC 30878

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. 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.

CareFusion Symbol

Indicates PATIENT EFFORT

CareFusion symbol

Indicates MANUAL BREATH

ACCEPT

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Symbol

Chapter 1: Introduction

Source/Compliance

Meaning

CareFusion Symbol

MAIN SCREEN

Symbol #417 IEC 5102

EVENT READY

CareFusion Symbol

MODE

CareFusion Symbol

ADVANCED SETTINGS

CareFusion Symbol

SET-UP for patient Data

CareFusion Symbol

SiPAP Duration

MDD Directive 93/42/EEC

CE Mark

Symbol #5307 IEC 60417

ALARM RESET

Symbol #5319 IEC 60417

ALARM SILENCE

CareFusion symbol

ADULT patient

CareFusion symbol

PEDIATRIC patient

CareFusion symbol

NEONATAL (Infant) patient

Graphical Symbol in general use internationally for “DO NOT”

CANCEL, do not accept entered values.

CareFusion symbol

Select DISPLAYED SCREEN function.

CANCEL

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Symbol

6

Source/Compliance

Meaning

Symbol 5467 IEC 60417

FREEZE the current display.

CareFusion symbol

Enable the ALARM LIMITS screen

CareFusion symbol

This symbol indicates a CONTROL LOCK.

CareFusion symbol

NEBULIZER port

CareFusion symbol

Increase OXYGEN

CareFusion symbol

PRINT SCREEN

CareFusion symbol

SUCTION port

CareFusion symbol

VARIABLE ORIFICE FLOW SENSOR connection

CareFusion symbol

HOT WIRE FLOW SENSOR connection

CareFusion symbol

ANALOG IN/OUT connection

CareFusion symbol

Display the MAIN SCREEN

CareFusion symbol

DO NOT BLOCK PORT

CareFusion symbol

EXTERNAL BATTERY connection

CareFusion symbol

Indicates GAS ID port

CareFusion symbol

OXYGEN SENSOR connection

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Source/Compliance

Meaning

CareFusion symbol

OVERPRESSURE relief

CareFusion symbol

REMOTE NURSE CALL connection

CareFusion symbol

UNIVERSAL INTERFACE MONITOR connection

CareFusion Symbol

This symbol indicates an EXTERNAL BATTERY INPUT

CareFusion Symbol

This symbol indicates an INTERNAL BATTERY FUSE

CareFusion Symbol

This symbol indicates ALARM LOUDNESS

CareFusion Symbol

Operating on Battery Indicator

CareFusion Symbol

Operating on Heliox

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Theory of Operation

General Description Avea is a software driven, servo-controlled ventilator designed to meet the requirements of neonate to adult patients. The design intent of the device is to provide a high performance software-driven gas delivery engine, which is capable of providing a full range of volume and pressure ventilation including dual limb NIPPV. This affords the flexibility of developing new modes of ventilation with no impact to the basic gas delivery engine. In addition, the device will contain a graphical user interface (GUI) that utilizes a 12.1-inch SVGA color LCD screen with integral touch screen. The GUI will be used to change settings and operating parameters as well as providing real time waveforms, digital monitors, and alarms. The device also contains an internal battery that serves as a backup in case of loss of hospital AC power. The Custom Cart may be equipped with tank holder, external batteries and battery tray for use of the Avea during inter-facility transport. There are three models of Avea; comprehensive, plus and standard. These are shown in table 2.1 based on the same basic platform. Additional models may be developed in the future by adding or removing software and/or hardware features to the existing platform. 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.

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Chapter 2: Theory of Operation

There are three models of Avea to choose from: The Comprehensive, Plus, and the Standard. The following matrix details the standard and optional functions available with each model. Table 2.1 Functions and Accessories

Standard

Plus

Comprehensive

Modes

All

All

All

Custom Cart

Option

Option

Included

External Battery (on custom cart only)

Option

Option

Option

Gas Tank Holder (on either cart)

Option

Option

Option

Internal Compressor

Option

Option

Included

Heliox Delivery

Option

Option

Included

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 Pressure Monitoring Esophageal Pressure Balloon Internal Compressor Heliox Delivery Optional Functions and Accessories

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