Mindray A5 User manual

Operating Instructions

Anesthesia System

ANESTHESIA SYSTEM

™

ANESTHESIA SYSTEM

™

A5_A3_Ops Covers-046-001606-00_Eng.indd 1 9/29/11 1:09 PM

Operating Instructions

Anesthesia System

ANESTHESIA SYSTEM

™

ANESTHESIA SYSTEM

™

A5_A3_Ops Covers-046-001613-00_Eng.indd 1 9/29/11 1:09 PM

A5™ and A3™ are U.S. trademarks of Mindray DS USA, Inc.

SELECTATEC® is a registered trademark of Datex-Ohmeda, Inc.

any form without permission of Mindray DS USA, Inc.

A5/A3™ Operating Instructions 046-003777-00 i

Table of Contents

Foreword ..............................................................................................................................................................................................................................ix

Indications For Use ...........................................................................................................................................................................................................ix

Responsibilities of Operators ........................................................................................................................................................................................ix

Warnings, Cautions, and Notes ....................................................................................................................................................................................ix

Warnings................................................................................................................................................................................................................................x

Cautions............................................................................................................................................................................................................................. xiv

Notes.................................................................................................................................................................................................................................. xvii

Intellectual Property Statement................................................................................................................................................................................ xix

Warranty Statements .................................................................................................................................................................................................... xix

Disclaimers..........................................................................................................................................................................................................................xx

Phone Numbers and How To Get Assistance.........................................................................................................................................................xx

Manufacturer’s Responsibility .....................................................................................................................................................................................xx

Manufacturer and Address .......................................................................................................................................................................................... xx

Symbols.............................................................................................................................................................................................................................. xxi

Product Description............................................................................................................................................1 - 1

General System Overview .........................................................................................................................................................................................1 - 2

General Description..........................................................................................................................................................................................1 - 2

Key Features ........................................................................................................................................................................................................1 - 3

Fresh Gas Dosing ...............................................................................................................................................................................................1 - 3

Flow Control........................................................................................................................................................................................................1 - 4

Vaporizer Mounting..........................................................................................................................................................................................1 - 4

Anesthesia Ventilator.......................................................................................................................................................................................1 - 5

Breathing System ..............................................................................................................................................................................................1 - 5

Active Anesthetic Gas Scavenging System..............................................................................................................................................1 - 6

Passive Anesthetic Gas Scavenging System (Optional).......................................................................................................................1 - 6

Power Management / Battery Supply........................................................................................................................................................1 - 6

Workplace Ergonomics....................................................................................................................................................................................1 - 8

Hook .......................................................................................................................................................................................................................1 - 8

Physical Views................................................................................................................................................................................................................1 - 9

Main Unit (Front View).....................................................................................................................................................................................1 - 9

Main Unit (Rear View).................................................................................................................................................................................... 1 - 11

Main Unit (Left View)..................................................................................................................................................................................... 1 - 13

Main Unit (Right View).................................................................................................................................................................................. 1 - 14

Main Unit (Top View)..................................................................................................................................................................................... 1 - 15

Breathing System (Top View)..................................................................................................................................................................... 1 - 16

Breathing System (Left View)..................................................................................................................................................................... 1 - 17

Active Anesthetic Gas Scavenging System........................................................................................................................................... 1 - 19

Passive Anesthetic Gas Scavenging System (AGSS) (Right View) ................................................................................................. 1 - 22

Installation ..........................................................................................................................................................2 - 1

Unpacking.......................................................................................................................................................................................................................2 - 3

Initial Setup.....................................................................................................................................................................................................................2 - 4

Install the Vaporizer.....................................................................................................................................................................................................2 - 5

Filling and Draining the Vaporizer ..............................................................................................................................................................2 - 7

Install the DGSS.............................................................................................................................................................................................................2 - 8

System Interface .................................................................................................................................................3 - 1

Main Screen Components.........................................................................................................................................................................................3 - 2

System Information Header .....................................................................................................................................................................................3 - 6

Elapsed / Countdown Timer..........................................................................................................................................................................3 - 6

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ii 046-003777-00 A5/A3™ Operating Instructions

Patient Size ..........................................................................................................................................................................................................3 - 7

Alarm and Prompt Messages ........................................................................................................................................................................3 - 7

Alarm Silence Icon.............................................................................................................................................................................................3 - 8

Date and Time ....................................................................................................................................................................................................3 - 9

Battery Status................................................................................................................................................................................................... 3 - 10

Fresh Gas Flow Display............................................................................................................................................................................................ 3 - 11

Waveforms Tab .......................................................................................................................................................................................................... 3 - 12

Waveforms Autoscaling ............................................................................................................................................................................... 3 - 12

Waveforms Manual Scaling ........................................................................................................................................................................ 3 - 13

Spirometry Tab (A5 Only)....................................................................................................................................................................................... 3 - 14

Loop Type.......................................................................................................................................................................................................... 3 - 16

Show Reference .............................................................................................................................................................................................. 3 - 17

Save Loop.......................................................................................................................................................................................................... 3 - 17

Review Loops Button .................................................................................................................................................................................... 3 - 17

Demographics Tab.................................................................................................................................................................................................... 3 - 20

Ventilation Mode Tabs............................................................................................................................................................................................. 3 - 21

Measured Values Area ............................................................................................................................................................................................. 3 - 24

System Softkeys ......................................................................................................................................................................................................... 3 - 25

Setup Softkey................................................................................................................................................................................................... 3 - 25

Alarms Softkey................................................................................................................................................................................................. 3 - 25

Silence Softkey ................................................................................................................................................................................................ 3 - 25

Capture Event (software bundle version 02.02.00 and later) ......................................................................................................... 3 - 25

History (software bundle version 02.02.00 and later) ....................................................................................................................... 3 - 25

Setup.............................................................................................................................................................................................................................. 3 - 32

General Tab ................................................................................................................................................................................................................. 3 - 32

Display Tab .................................................................................................................................................................................................................. 3 - 34

System Tab................................................................................................................................................................................................................... 3 - 38

Network Configuration................................................................................................................................................................................. 3 - 41

Service Tab................................................................................................................................................................................................................... 3 - 44

Preoperative Tests..............................................................................................................................................4 - 1

Preoperative Test Schedules....................................................................................................................................................................................4 - 2

Test Intervals .......................................................................................................................................................................................................4 - 2

Inspect the System.......................................................................................................................................................................................................4 - 3

Pre-Operative Checkout List.....................................................................................................................................................................................4 - 4

Introduction.........................................................................................................................................................................................................4 - 4

Suggested Pre-Operative Checkout List ...................................................................................................................................................4 - 4

System Self-Test............................................................................................................................................................................................................4 - 6

Leak and Compliance Tests ......................................................................................................................................................................................4 - 9

Automatic Circuit Leak and Compliance Test.........................................................................................................................................4 - 9

Manual Circuit Leak Test.............................................................................................................................................................................. 4 - 14

Preoperative Check List (software bundle version 02.09.00 and later).................................................................................................. 4 - 17

Power Failure Alarm Test........................................................................................................................................................................................ 4 - 18

Pipeline Tests .............................................................................................................................................................................................................. 4 - 18

O2Pipeline Test............................................................................................................................................................................................... 4 - 18

N2O Pipeline Test............................................................................................................................................................................................ 4 - 18

Air Pipeline Test............................................................................................................................................................................................... 4 - 19

Basic Ventilation Testing......................................................................................................................................................................................... 4 - 19

Cylinder Tests.............................................................................................................................................................................................................. 4 - 20

Check the Cylinder Pressure....................................................................................................................................................................... 4 - 20

O2Cylinder High Pressure Leak Test ....................................................................................................................................................... 4 - 20

N2O Cylinder High Pressure Leak Test .................................................................................................................................................... 4 - 20

Air Cylinder High Pressure Leak Test....................................................................................................................................................... 4 - 20

A5/A3™ Operating Instructions 046-003777-00 iii

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Flow Control System Test....................................................................................................................................................................................... 4 - 21

Vaporizer Tests ........................................................................................................................................................................................................... 4 - 22

Vaporizer Back Pressure Test...................................................................................................................................................................... 4 - 22

Manual Leak Test ............................................................................................................................................................................................ 4 - 22

Vaporizer Leak Test........................................................................................................................................................................................ 4 - 22

Breathing System Tests........................................................................................................................................................................................... 4 - 24

Bellows Test...................................................................................................................................................................................................... 4 - 24

Breathing System Leak Test in Manual Ventilation Status .............................................................................................................. 4 - 24

APL Valve Test.................................................................................................................................................................................................. 4 - 25

Alarm Tests .................................................................................................................................................................................................................. 4 - 26

Prepare for Alarm Tests ................................................................................................................................................................................ 4 - 26

Test the O2Concentration Monitoring and Alarms........................................................................................................................... 4 - 26

Test the Low Minute Volume (MV) Alarm.............................................................................................................................................. 4 - 27

Test the Apnea Alarm.................................................................................................................................................................................... 4 - 27

Test the Continuous Airway Pressure Alarm ........................................................................................................................................ 4 - 27

Test the High Paw Alarm.............................................................................................................................................................................. 4 - 28

Test the Low Paw Alarm............................................................................................................................................................................... 4 - 28

Preoperative Preparations ..................................................................................................................................................................................... 4 - 28

Inspect the Active/Passive Anesthetic Gas Scavenging System .............................................................................................................. 4 - 29

Inspect the AGSS............................................................................................................................................................................................. 4 - 29

Inspect the DGSS ............................................................................................................................................................................................ 4 - 29

Inspect the Passive AGSS............................................................................................................................................................................. 4 - 29

Operations...........................................................................................................................................................5 - 1

Powering On the A5/A3 Anesthesia System ......................................................................................................................................................5 - 2

Powering Off the A5/A3 Anesthesia System ......................................................................................................................................................5 - 2

Patient Setup..................................................................................................................................................................................................................5 - 3

End Case / Standby Mode ..............................................................................................................................................................................5 - 3

Select the Patient Size (Adult, Pediatric, Infant) .....................................................................................................................................5 - 5

Oxygen Sensor Calibration .......................................................................................................................................................................................5 - 5

Input Fresh Gas .............................................................................................................................................................................................................5 - 6

Set N2O, Air, and O2Inputs ............................................................................................................................................................................5 - 6

Set Anesthetic Agent .......................................................................................................................................................................................5 - 7

Ventilation Modes........................................................................................................................................................................................................5 - 8

Monitored Parameters.....................................................................................................................................................................................5 - 8

Ventilation Modes .............................................................................................................................................................................................5 - 8

Change Ventilation Mode ..............................................................................................................................................................................5 - 8

Set Manual Ventilation Mode........................................................................................................................................................................5 - 9

Setting Monitor Mode (A5 with AG Module connected)................................................................................................................. 5 - 11

Make Settings before Starting Mechanical Ventilation Mode ....................................................................................................... 5 - 14

Volume Control Ventilation (VCV)............................................................................................................................................................ 5 - 14

Pressure Control Ventilation (PCV)........................................................................................................................................................... 5 - 15

Synchronized Intermittent Mandatory Ventilation (SIMV).............................................................................................................. 5 - 16

Pressure Support Ventilation (PS)............................................................................................................................................................. 5 - 18

Start Mechanical Ventilation ................................................................................................................................................................................. 5 - 19

Stop Mechanical Ventilation ................................................................................................................................................................................. 5 - 19

Relationships of Ventilation Parameters........................................................................................................................................................... 5 - 19

Parameter Monitoring (Numerics) ...................................................................................................................................................................... 5 - 20

Pressure.............................................................................................................................................................................................................. 5 - 20

Volume ............................................................................................................................................................................................................... 5 - 20

Gas (available with the AG module) ........................................................................................................................................................ 5 - 21

Inspired O2(available without the AG module).................................................................................................................................. 5 - 21

Parameter Monitoring (Waveforms)................................................................................................................................................................... 5 - 22

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iv 046-003777-00 A5/A3™ Operating Instructions

Pressure Waveform........................................................................................................................................................................................ 5 - 22

Flow Waveform ............................................................................................................................................................................................... 5 - 22

Volume Waveform ......................................................................................................................................................................................... 5 - 23

Gas Waveform (available with the AG module) .................................................................................................................................. 5 - 23

Waveform Autoscaling................................................................................................................................................................................. 5 - 25

Parameter Monitoring (Spirometry, A5 Only) ................................................................................................................................................. 5 - 26

Alarms and Messages .........................................................................................................................................6 - 1

Introduction ...................................................................................................................................................................................................................6 - 2

Alarm System Self-Test....................................................................................................................................................................................6 - 2

Types of Alarms and Messages.....................................................................................................................................................................6 - 3

Alarm Indicators.................................................................................................................................................................................................6 - 4

Displaying Alarms ........................................................................................................................................................................................................6 - 5

Displayed Order of Alarm Messages...........................................................................................................................................................6 - 6

Setting Alarm Volume ................................................................................................................................................................................................6 - 7

Silencing Alarms ...........................................................................................................................................................................................................6 - 8

Alarm Limits....................................................................................................................................................................................................................6 - 9

Setting Alarm Limits .........................................................................................................................................................................................6 - 9

Loading Alarm Defaults................................................................................................................................................................................ 6 - 12

Auto Alarm Limits........................................................................................................................................................................................... 6 - 14

Setting CO2 Apnea Delay Time (software bundle version 02.09.00 and later)........................................................................ 6 - 14

Alarm and Prompt Messages................................................................................................................................................................................ 6 - 15

Technical Alarm Messages .......................................................................................................................................................................... 6 - 18

Prompt Messages ........................................................................................................................................................................................... 6 - 26

Maintenance .......................................................................................................................................................7 - 1

Theory of Operation ....................................................................................................................................................................................................7 - 3

Block Diagram................................................................................................................................................................................................................7 - 3

Maintenance Schedule...............................................................................................................................................................................................7 - 4

Breathing System Maintenance..............................................................................................................................................................................7 - 4

Flow Sensor Calibration .............................................................................................................................................................................................7 - 5

O2Sensor Calibration..................................................................................................................................................................................................7 - 6

Calibrate the O2 Sensor...................................................................................................................................................................................7 - 7

Water Build-up in the Flow Sensor.........................................................................................................................................................................7 - 9

Prevent Water Build-up...................................................................................................................................................................................7 - 9

Clear Water Build-up ........................................................................................................................................................................................7 - 9

Waste Gas Transfer Tube Maintenance................................................................................................................................................................7 - 9

Electrical Safety Inspection.......................................................................................................................................................................................7 - 9

Auxiliary Electrical Outlet Test ......................................................................................................................................................................7 - 9

Electrical Safety Inspection Test................................................................................................................................................................ 7 - 10

Cleaning and Disinfection...................................................................................................................................................................................... 7 - 11

General Guidelines......................................................................................................................................................................................... 7 - 11

Cleaning and Disinfecting Agents / Autoclaving................................................................................................................................ 7 - 11

External Surfaces............................................................................................................................................................................................. 7 - 12

Bellows Assembly........................................................................................................................................................................................... 7 - 12

Inspiration and Expiration Valves............................................................................................................................................................. 7 - 15

Oxygen Sensor................................................................................................................................................................................................. 7 - 18

APL Valve........................................................................................................................................................................................................... 7 - 19

PAW Gauge....................................................................................................................................................................................................... 7 - 20

Bag Arm.............................................................................................................................................................................................................. 7 - 21

Absorber Canister........................................................................................................................................................................................... 7 - 22

Breathing System Block................................................................................................................................................................................ 7 - 25

Active Anesthetic Gas Scavenging System........................................................................................................................................... 7 - 28

Regular Maintenance............................................................................................................................................................................................... 7 - 30

A5/A3™ Operating Instructions 046-003777-00 v

Table of Contents

AG and O2 Concentration Monitoring (Optional)............................................................................................8 - 1

Introduction ...................................................................................................................................................................................................................8 - 2

Understand MAC Values............................................................................................................................................................................................8 - 3

Identify External AG Modules ..................................................................................................................................................................................8 - 4

Prepare to Measure AG ..............................................................................................................................................................................................8 - 5

Make AG Settings .........................................................................................................................................................................................................8 - 6

Set CO2 Unit ........................................................................................................................................................................................................8 - 6

Set CO2 Placement ...........................................................................................................................................................................................8 - 6

Set CO2 Scale ......................................................................................................................................................................................................8 - 6

Gas Bench Flow Rate ........................................................................................................................................................................................8 - 6

Set Alarm Limits .................................................................................................................................................................................................8 - 7

Measurement Limitations .........................................................................................................................................................................................8 - 8

Troubleshooting...........................................................................................................................................................................................................8 - 8

Scavenge the Sample Gas.........................................................................................................................................................................................8 - 9

Calibrate the AG Module ........................................................................................................................................................................................ 8 - 10

Product Specifications........................................................................................................................................9 - 1

Standards Compliance ...............................................................................................................................................................................................9 - 2

Safety Designations.....................................................................................................................................................................................................9 - 4

Oxygen Enriched Environments ..................................................................................................................................................................9 - 4

Wiring and PC Board Materials.....................................................................................................................................................................9 - 4

Physical Specifications................................................................................................................................................................................................9 - 5

Stability Configurations and Conditions..............................................................................................................................................................9 - 5

Environmental Specifications ..................................................................................................................................................................................9 - 6

Electrical Specifications..............................................................................................................................................................................................9 - 7

Main Electrical Power Specifications..........................................................................................................................................................9 - 7

Battery Power Specifications.........................................................................................................................................................................9 - 7

Auxiliary Electrical Outlets..............................................................................................................................................................................9 - 7

Communication Ports......................................................................................................................................................................................9 - 8

Pneumatic Specifications ..........................................................................................................................................................................................9 - 9

Pipeline Supply (N2O, Air, O2) .......................................................................................................................................................................9 - 9

Cylinder Supply (N2O, Air, O2).......................................................................................................................................................................9 - 9

Vaporizer Connections ....................................................................................................................................................................................9 - 9

Drive Gas...............................................................................................................................................................................................................9 - 9

N2O Automatic Cutoff......................................................................................................................................................................................9 - 9

O2Controls ....................................................................................................................................................................................................... 9 - 10

Oxygen Ratio Controller............................................................................................................................................................................... 9 - 10

Breathing System Specifications ......................................................................................................................................................................... 9 - 10

Breathing System Volume........................................................................................................................................................................... 9 - 10

CO2Absorber Assembly............................................................................................................................................................................... 9 - 10

Water Trap......................................................................................................................................................................................................... 9 - 10

Breathing System Connections................................................................................................................................................................. 9 - 10

Resistance.......................................................................................................................................................................................................... 9 - 12

Breathing System Temperature Controller........................................................................................................................................... 9 - 13

Breathing Circuit Parameters ..................................................................................................................................................................... 9 - 13

Materials ............................................................................................................................................................................................................ 9 - 13

Anesthetic Gas Scavenging System (AGSS)..................................................................................................................................................... 9 - 14

Monitor Module......................................................................................................................................................................................................... 9 - 14

AG Module ........................................................................................................................................................................................................ 9 - 14

Alarms................................................................................................................................................................................................................. 9 - 17

Effect of Interfering Gas on AG Measured Value................................................................................................................................. 9 - 18

Ventilator Specifications......................................................................................................................................................................................... 9 - 19

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vi 046-003777-00 A5/A3™ Operating Instructions

Displays and Controls Specifications ................................................................................................................................................................. 9 - 21

Electronic Controls......................................................................................................................................................................................... 9 - 21

Pneumatic Controls ....................................................................................................................................................................................... 9 - 22

Safety Specifications ................................................................................................................................................................................................ 9 - 24

ASTM F 1208 – 89 (2005) Disclosures................................................................................................................................................................. 9 - 25

Leakage of Breathing System..................................................................................................................................................................... 9 - 25

Resistance of Breathing Systems .............................................................................................................................................................. 9 - 25

CO2Absorber Resistance............................................................................................................................................................................. 9 - 25

CO2Absorber Capacity................................................................................................................................................................................. 9 - 25

Unidirectional Valve Opening Pressure.................................................................................................................................................. 9 - 26

Data Storage (Non-Volatile) and Recording .................................................................................................................................................... 9 - 26

Electromagnetic Compatibility ............................................................................................................................................................................ 9 - 27

Accessories ..........................................................................................................................................................A - 1

Accessory Kits ............................................................................................................................................................................................................... A - 2

AG Accessories ............................................................................................................................................................................................................. A - 2

CO2Absorbent Canister............................................................................................................................................................................................ A - 2

Gas Cylinder Accessories .......................................................................................................................................................................................... A - 2

Gas Supply Hoses ........................................................................................................................................................................................................ A - 3

Manuals and Reference Cards ................................................................................................................................................................................ A - 3

Mounting Accessories ............................................................................................................................................................................................... A - 3

Networking and USB Storage ................................................................................................................................................................................. A - 4

Vaporizers....................................................................................................................................................................................................................... A - 4

Scavenging Accessories............................................................................................................................................................................................ A - 5

User Accessible Spare Parts ...............................................................................................................................B - 1

Active AGSS ................................................................................................................................................................................................................... B - 2

Flow Sensor ................................................................................................................................................................................................................... B - 2

O2Sensor........................................................................................................................................................................................................................ B - 3

Battery ............................................................................................................................................................................................................................. B - 3

Parameters and Factory Defaults......................................................................................................................C - 1

Waveform/Spirometry Tabs (A5 Only)................................................................................................................................................................. C - 2

Setup Menu ................................................................................................................................................................................................................... C - 5

Alarm Volume and History....................................................................................................................................................................................... C - 8

Demographics .............................................................................................................................................................................................................. C - 9

Linked Ventilation Parameter ...............................................................................................................................................................................C - 13

Ventilation Parameter Relationships..................................................................................................................................................................C - 15

Pneumatic Diagram........................................................................................................................................... D - 1

Pneumatic Diagram of the A5/A3 System..........................................................................................................................................................D - 2

Abbreviations, Symbols, and Units of Measure ............................................................................................... E - 1

Abbreviations ................................................................................................................................................................................................................E - 2

Units of Measure...........................................................................................................................................................................................................E - 4

Attention Symbols .......................................................................................................................................................................................................E - 5

Preparation for Malignant Hyperthermia Susceptible Patients.....................................................................F- 1

Malignant Hyperthermia Causes, Effects and Treatment ..............................................................................................................................F - 2

A5/A3™ Operating Instructions 046-003777-00 vii

Table of Contents

Malignant Hyperthermia Washout ........................................................................................................................................................................F - 2

Washout Procedure for Malignant Hyperthermia Susceptible Patients with A5 Anesthesia Delivery Systems........................F - 2

References.......................................................................................................................................................................................................................F - 4

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viii 046-003777-00 A5/A3™ Operating Instructions

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A5/A3™ Operating Instructions 046-003777-00 ix

Foreword Introduction

Foreword

WARNING: Do not operate the A5/A3 Anesthesia System before reading these

instructions.

The operating instructions for the A5/A3 Anesthesia Delivery System (hereinafter referred to as A5/A3

Anesthesia System, A5/A3 System, A5/A3, or individual A5 and A3) are intended to provide

information for proper installation, operation, and general maintenance of the A5/A3 System to the

user.

General knowledge and understanding of the features and functions of the A5/A3 System are

prerequisites for its proper use.

For servicing information or assistance, please contact an authorized representative in your area.

Rx only: U.S. Federal Law restricts this device to sale by or on the order of a

physician or other practitioner licensed by state law to use or order the

use of this device.

NOTE: Figures in this manual are provided for reference purposes only.

Screens may differ based on the system configuration and selected

parameters.

Indications For Use

The A5/A3 Anesthesia System is a device used to administer to a patient, continuously or

intermittently, a general inhalation anesthetic, and to maintain a patient's ventilation.

The A5/A3 is intended for use by licensed clinicians, for patients requiring anesthesia within a health

care facility, and can be used for adult and pediatric populations.

WARNING: The A5/A3 is intended to be operated only by licensed clinicians and

qualified anesthesia personnel who have received adequate training in

its use. Anyone unauthorized or untrained must not perform any

operation on the A5/A3.

WARNING: The A5/A3 is not suitable for use in an MRI environment.

Responsibilities of Operators

The proper function of the A5/A3 System can only be guaranteed if it is operated and serviced in

accordance with the information provided in this manual and by an authorized Mindray service

representative. Non-compliance with this information voids all guarantee claims.

The A5/A3 System must be operated by qualified and trained personnel only. All operators must fully

observe these operating instructions and relevant additional documentation. They must also comply

with the WARNINGS, CAUTIONS, and NOTES detailed in this manual.

Warnings, Cautions, and Notes

Please adhere to all warnings, cautions, and notes that are listed throughout this manual. They are

summarized here for your reference.

WARNING — Indicates a potential hazard or unsafe practice that, if not avoided, could result in death

or serious injury to the patient or user.

CAUTION — Indicates a potential hazard or unsafe practice that, if not avoided, could result in

product/property damage or minor personal injury to the patient or user.

NOTE — Provides application tips or other useful information.

Introduction Warnings

x 046-003777-00 A5/A3™ Operating Instructions

Warnings

WARNING: Do not operate the A5/A3 Anesthesia System before reading these

instructions.

WARNING: All analog or digital products connected to this system must be

certified passing the specified IEC standards (such as IEC 60950 for data

processing equipment and IEC 60601-1 for medical electrical

equipment). All configurations shall comply with the valid version of

IEC 60601-1. The personnel who are responsible for connecting the

optional equipment to the I/O signal port shall be responsible for

medical system configuration and system compliance with IEC 60601-1.

WARNING: This machine must only be operated by trained, skilled medical staff.

WARNING: Before putting the system into operation, the operator must verify that

the equipment, connecting cables, and accessories are in correct

working order and operating condition.

WARNING: The equipment must be connected to a properly installed power outlet

with protective earth contacts only. If the installation does not provide

for a protective earth conductor, disconnect it from the power line or

operate from the equipment’s internal battery supply.

WARNING: Multiple AC power outlets are provided on the rear of the A5/A3. These

outlets are intended to supply power to additional equipment that

form a part of the anesthesia system (i.e. vaporizers, gas analyzers,

etc.). Do not connect other equipment to these outlets, as patient

leakage current may be affected. Each outlet is rated 3 A; the total

current that may be drawn through all outlets is 10 A on the A5 System

and 9 A on the A3 System; do not attempt to exceed these load ratings.

Do not connect additional Multiple Portable Socket Outlets (i.e.

Multiple outlet extension cords) (MPSOs) or extension cords to these

outlets.

WARNING: Do not put MPSOs on the floor.

WARNING: Connect the A5/A3 Anesthesia System to an AC power source before the

internal battery power source is depleted.

WARNING: Do not open the equipment housings. All servicing and future

upgrades must be carried out only by trained and authorized Mindray

personnel.

WARNING: Do not rely exclusively on the audible alarm system for patient

monitoring.

WARNING: Adjustment of alarm volume to a low level may result in a hazard to the

patient.

WARNING: Alarm settings should be customized according to different patient

situations. Constantly keeping the patient under close surveillance is

the most reliable way for safe patient monitoring.

WARNING: The physiological parameters and alarm messages displayed on the

screen of the equipment are for the caregiver’s reference only and

cannot be directly used as the basis for clinical treatment.

WARNING: Dispose of the packaging material, observing the applicable waste

control regulations and keeping it out of children’s reach.

A5/A3™ Operating Instructions 046-003777-00 xi

Warnings Introduction

WARNING: To avoid the possibility of explosion, do not use the equipment in the

presence of flammable anesthetic agents, vapors or liquids. Do not use

flammable anesthetic agents such as ether and cyclopropane for this

equipment. Use only non-flammable anesthetic agents that meet the

requirements specified in ISO 80601-2-13. The A5/A3 Anesthesia

System can be used with halothane, enflurane, isoflurane, sevoflurane,

and desflurane. Only one anesthetic agent can be used at a time.

WARNING: Fresh gas flow must never be switched off before the vaporizer is

switched off. The vaporizer must never be left switched on without a

fresh-gas flow. Anesthetic agent vapor at a high concentration can get

into the machine lines and ambient air, causing harm to people and

materials.

WARNING: To avoid the risk of electric shock, this equipment must only be

connected to a supply mains with protective earth.

WARNING: The use of anti-static or electrically conductive breathing tubes, when

utilizing high frequency electric surgery equipment, may cause burns,

and is therefore not recommended in any application of this machine.

WARNING: Possible electric shock hazard. The machine may only be opened by

authorized service personnel.

WARNING: The patient should be visually monitored by qualified personnel. In

certain situations, life-threatening circumstances may occur that may

not necessarily trigger an alarm.

WARNING: Always set the alarm limits so that the alarm is triggered before a

hazardous situation occurs. Incorrectly set alarm limits may result in

operating personnel not being aware of drastic changes in the patient’s

condition.

WARNING: Connection of both medical and non-medical equipment to the

auxiliary mains socket outlet (s) may increase the leakage currents to

values exceeding the allowable limits.

WARNING: Electric shock and fire hazard: Do not clean the machine while it is

powered on and/or plugged into an outlet.

WARNING: Disconnect the power plug from the mains supply before removing the

rear panels or servicing the A5/A3 unit.

WARNING: Malfunction of the central gas supply system may cause more than one

or even all devices connected to it to stop their operation

simultaneously.

WARNING: The anesthesia system will cease to deliver gas at pressures below the

minimum specified gas pipeline supply pressure.

WARNING: Use a cleaning and disinfection schedule that conforms to your

institution's disinfection and risk-management policies.

• Refer to the material safety data sheet as applicable.

• Refer to the operation and maintenance manuals of all

disinfection equipment.

• Do not inhale fumes that may result from any disinfection process.

WARNING: Use extreme care while handling the absorbent as it contains a caustic

irritant.

Introduction Warnings

xii 046-003777-00 A5/A3™ Operating Instructions

WARNING: Use care in lifting and manipulating vaporizers during the mounting

process as their weight may be greater than expected, based on their

size and shape.

WARNING: Do not use talc, zinc stearate, calcium carbonate, corn starch, or similar

material to prevent sticking of the bellows, as these materials may

enter the patient's lungs or airway, causing irritation or injury.

WARNING: All gas supplies should be of medical grade.

WARNING: Single use respiratory hoses, face masks, sensors, sodalime, water

traps, sampling lines, airway adapters, and other single use items may

be considered potential biologically hazardous items and should not

be reused. Dispose of these items in accordance with hospital policy

and local regulations for contaminated and biologically hazardous

items.

WARNING: To avoid endangering a patient, do not perform testing or maintenance

when the machine is in use.

WARNING: Review the performance specifications of the disposal system that the

transfer and receiving systems are intended to be used with, to ensure

compatibility.

WARNING: The A5/A3 should not be used adjacent to or stacked with other

equipment. If adjacent or stacked use is necessary, the A5/A3 should be

observed to verify normal operation in the configuration in which it will

be used.

WARNING: Ensure that the current alarm presets are appropriate before use on

each patient.

WARNING: A hazard can exist if different alarm presets are used for the same or

similar equipment in any single area.

WARNING: Due to the size and weight of the A5/A3, it should only be moved by

qualified personnel.

WARNING: Overloading machine may cause tipping. Equipment attached to the

side of the machine should fall within the rated weights to prevent

tipping of the machine.

WARNING: Excess load may cause a tip hazard while moving the A5/A3. Before

moving, remove all equipment from the top shelf and all monitoring

equipment mounted to the side of the A5/A3. Use care when moving

the A5/A3 up or down inclines, around corners, and across thresholds.

Do not attempt to roll the A5/A3 over hoses, cords, or other obstacles.

WARNING: Leaks or internal venting of sampled gas may affect accuracy. Perform

the proper preoperative tests to ensure that the device is performing

properly. Leaky circuits can not be used.

WARNING: Connection of the A5/A3 exhaust port to the hospital’s waste gas

scavenging system is strongly recommended to prevent exposure of

hospital personnel to the A5/A3 exhaust gases.

WARNING: Operation of the A5/A3 below the minimum flow values may cause

inaccurate results.

WARNING: Ensure that an independent means of ventilation (e.g. a self-inflating

manually powered resuscitator with mask) is available whenever the

A5/A3 is in use.

A5/A3™ Operating Instructions 046-003777-00 xiii

Warnings Introduction

WARNING: Usage of accessories found with damaged packaging may cause

biocontamination or failure. The operator should check accessory

packaging integrity before use.

WARNING: Before using the A5/A3 System (after cleaning or disinfecting), power

up the system and follow the on-screen prompts to perform the leak

test and the compliance test. (see section4.5 (page 4-9) "Leak and

Compliance Tests".)

WARNING: Improperly cleaned materials may result in biocontamination. Use a

cleaning and disinfection schedule that conforms to your institution's

disinfection and risk-management policies.

• Refer to the material safety data as applicable.

• Refer to the operation and maintenance manuals of all disinfection

equipment.

The user should follow the recommended disinfection routine for this

machine and any reusable accessories.

WARNING: If the A5/A3 is damaged in any way that compromises the safety of the

patient or user, discontinue use and attach a visible tag that marks the

A5/A3 as unusable. Call Mindray Technical Support.

WARNING: Oxygen, when present in high concentrations, can significantly

increase the chance of fire or an explosion. Oil and grease may

spontaneously ignite and should not be used where oxygen

enrichment may occur.

WARNING: Use of lubricants not recommended by Mindray may increase the

danger of fire or explosion. Use lubricants approved by Mindray.

WARNING: Low-pressure regulators and flow-meters are susceptible to high

pressure, and may burst if improperly maintained or disassembled

while under pressure. Changing connectors or disassembling should be

performed only by qualified personnel.

WARNING: Do not disassemble the low-pressure regulator, flow-metering device,

or connector while under pressure. The release of sudden pressure may

cause injury.

WARNING: Review the specifications of the AGSS transfer and receiving systems

and the specifications of the A5/A3 System to ensure compatibility and

to prevent a mismatched receiving system.

WARNING: Avoid connecting two or more hose assemblies in series as this may

cause a loss of pressure and flow.

WARNING: A hazard may exist due to the use of improper connectors. Ensure all

assemblies use the proper connectors.

WARNING: Avoid replacing a high-pressure flexible connection with one of lower

nominal inlet pressure.

WARNING: Reusing breathing circuits or reusable accessories that are not

disinfected may cause cross-contamination. Disinfect the breathing

circuits and reusable accessories before use.

WARNING: Inspect all breathing system components carefully before each use.

Ensure all components do not contain any obstructions or debris that

can cause a potential hazard to the patient.

WARNING: Use breathing circuits and manual bags in accordance with ASTM F1208

and compatible with standard 22mm male conical fittings per ASTM

specifications F 1054.

Introduction Cautions

xiv 046-003777-00 A5/A3™ Operating Instructions

WARNING: The mains plug is used to isolate the Anesthesia System circuits

electrically from the SUPPLY MAINS. Do not position the Anesthesia

System so that it is difficult to operate the plug.

WARNING: Do not touch the patient when connecting the peripheral equipment

via the I/O signal ports or replacing the oxygen cell to prevent patient

leakage current from exceeding the requirements specified by the

standard.

WARNING: If the Drive Gas Pressure Low alarm occurs when the gas supply

pressure is greater than 200 kPa, contact your service personnel or us.

WARNING: The anesthesia system shall not be serviced or maintained while being

connected on a patient.

WARNING: Additional MULTIPLE SOCKET- OUTLET or extension cord shall not be

connected to the ME SYSTEM.

Cautions

CAUTION: To ensure patient safety, use only parts and accessories specified in this

manual.

CAUTION: At the end of its service life, the equipment, as well as its accessories,

must be disposed of in compliance with the guidelines regulating the

disposal of such products, and in accordance with local regulations for

contaminated and biologically hazardous items.

CAUTION: Magnetic and electrical fields are capable of interfering with the proper

performance of the equipment. Ensure that all external devices

operating in the vicinity of the equipment comply with the relevant

EMC requirements. Mobile phones, x-ray equipment, and MRI devices

are possible sources of interference as they may emit higher levels of

electromagnetic radiation.

CAUTION: This system operates correctly at the electrical interference levels

identified in this manual. Higher levels can cause nuisance alarms that

may stop mechanical ventilation. Be aware of false alarms caused by

high-intensity electrical fields.

CAUTION: The A5/A3 Anesthesia System may become unstable if the unit is tilted

beyond 10 degrees. Use extreme caution when moving or resting the

unit on surfaces exceeding a 10 degree slope. Do not hang articles on

the sides of the unit that would cause an excessive imbalance.

CAUTION: Perform the daily checks specified on the checklist. In case of a system

fault, do not operate the system until the fault has been corrected.

CAUTION: Before starting the machine, users must be familiar with the

information contained in these Operating Instructions and must have

been trained by an authorized representative.

CAUTION: If the machine does not function as described, it must be examined and

repaired as necessary by qualified service personnel before being

returned to use.

CAUTION: Handle the machine with care to prevent damage or functional faults.

CAUTION: Ensure that the gas supply of the machine always complies with the

technical specifications.

A5/A3™ Operating Instructions 046-003777-00 xv

Cautions Introduction

CAUTION: Before clinical use, the machine must be correctly calibrated and/or the

respective tests must be performed, as described in these Operating

Instructions.

CAUTION: If system faults occur during the initial calibration or testing, the

machine should not be operated until those faults have been corrected

by a qualified service person.

CAUTION: After servicing, functional, sensor, and system tests must be performed

before clinical use.

CAUTION: Only vaporizers with Selectatec Interlock-Systems may be used with

the A5/A3 unit.

CAUTION: After each exchange of a vaporizer, perform a vaporizer leak test.

CAUTION: Use cleaning agent sparingly. Excess fluid could enter the machine,

causing damage.

CAUTION: Do not autoclave any parts of the A5/A3 unless specifically identified as

autoclavable in this manual. Clean the A5/A3 only as specified in this

manual.

CAUTION: To prevent system damage:

• Refer to the literature supplied by the manufacturer of the

cleaning agent.

• Never use organic, halogenated or petroleum-based solvents,

anesthetics, glass cleaning agents, acetone or other irritant

agents.

• Never use abrasive agents (i.e. steel wool or silver polish) to clean

components.

• Keep all liquids away from electronic components.

• Prevent liquid from entering the equipment.

• All cleaning solutions used must have a pH between 7.0 and 10.5.

CAUTION: Never immerse the oxygen sensor or its connector in any type of liquid.

• Dispose of the oxygen sensor as per the local regulations.

CAUTION: Do not use acetic hydroperoxide or formaldehyde steaming.

CAUTION: The valve disc in each of the inhalation and exhalation valve assemblies

on the breathing system is fragile and must be handled with care while

removing the valve cage from the valve assembly.

CAUTION: If moisture remains in the bellows after cleaning, the bellows surface

folds may become tacky and prevent the bellows from properly

expanding. Ensure all moisture is removed from the bellows after

cleaning.

CAUTION: Only connect Mindray approved equipment to the A5/A3

communication ports. Equipment connected to the A5/A3 ethernet

ports must comply with IEC 60950.

CAUTION: Do not connect any non-isolated devices to the DB9/RS232C interface

of the A5/A3.

CAUTION: Do not connect any devices to the SB ports other than Mindray

approved USB storage devices and a supported USB mouse (see

‘‘Networking and USB Storage’’ on page A-4).

Introduction Cautions

xvi 046-003777-00 A5/A3™ Operating Instructions

CAUTION: Do not wash the inner surface of the oxygen sensor.

CAUTION: Do not autoclave the following components: Paw gauge, oxygen

sensor, flow sensor, and bellows. These components cannot withstand

immersion or the heat and pressure of autoclaving.

CAUTION: Users should monitor oxygen percentage (FiO2%) when using the

Auxiliary O2/Air Flow Meters. Unknown oxygen concentrations may be

delivered to the patient unless oxygen monitoring is used.

CAUTION: The A5/A3 is NOT suitable for use in a magnetic resonance imaging

(MRI) environment.

CAUTION: To ensure measurement accuracy and to avoid possible damage to the

A5/A3, use only Mindray-approved cables and accessories.

CAUTION: Use the power cord provided with the product. If a substitute is

necessary, use only hospital grade power cords.

CAUTION: Do not use a damaged or broken unit or accessory. Periodically check

all cables (e.g., AC line cord and patient connection cables) for damage

that may occur through normal use. Replace cables if damaged in any

way.

CAUTION: Use of other oxygen sensors may cause improper oximeter

performance.

CAUTION: Unintended movement may occur if the casters are not locked. The

operator should lock casters during use of the machine.

CAUTION: Unsecured devices may slide off the top shelf. Devices should be

securely attached to the top shelf.

CAUTION: The voltage on the auxiliary outlets is the same voltage as the outlet

into which the A5/A3 machine is plugged. Ensure that devices plugged

into the auxiliary outlets are rated for the same supply voltage as the

A5/A3.

CAUTION: During the transport and storage of the vaporizer, block the gas inlet

and outlet of the vaporizer with plugs to prevent foreign substances

from entering the vaporizer.

CAUTION: Do not use any flow outlets as handles for moving the A5/A3. The flow

outlets may become damaged. Use the metal side bars on the main

body when moving the A5/A3.

CAUTION: Do not push down on the bag arm forcefully or hang heavy objects

onto it. Excessive weight may bend and damage the bag arm.

CAUTION: Use caution when disconnecting “quick connectors”, as the sudden

release of pressure may cause injury.

CAUTION: Avoid factors that can contribute to deterioration of the hose

assemblies. Factors include excessive bending, crushing, abrasion,

system pressures and temperatures that exceed hose ratings, and

improper installation.

CAUTION: Use care in lifting and manipulating the breathing system block during

removal from its mounting arm as handling may be awkward due to its

weight and shape.

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