Mindray A3-A5 User manual

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Operating Instructions

™

Anesthesia System

Operating Instructions

™

Anesthesia System

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

Selectatec® is a registered trademark of Ohmeda.

Table of Contents

Foreword .................................................................................................................................................................................................................................vii

Indications For Use ..............................................................................................................................................................................................................vii

Responsibilities of Operators...........................................................................................................................................................................................vii

Warnings, Cautions, and Notes.......................................................................................................................................................................................vii

Warnings..................................................................................................................................................................................................................................viii

Cautions...................................................................................................................................................................................................................................xii

Notes.........................................................................................................................................................................................................................................xv

Warranty Statements ..........................................................................................................................................................................................................xvii

Disclaimers..............................................................................................................................................................................................................................xvii

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

Manufacturer’s Responsibility .........................................................................................................................................................................................xviii

Symbols....................................................................................................................................................................................................................................xviii

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

Flow/Pressure Sensing ...................................................................................................................................................................................1 - 4

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

Anesthesia Ventilator.................................................................................................................................................................................................1 - 4

Breathing System ........................................................................................................................................................................................................1 - 4

Anesthetic Gas Scavenging System (AGSS).......................................................................................................................................................1 - 5

Power Management / Battery Supply..................................................................................................................................................................1 - 5

Workplace Ergonomics..............................................................................................................................................................................................1 - 7

Hook .................................................................................................................................................................................................................................1 - 7

Physical Views..........................................................................................................................................................................................................................1 - 8

Main Unit (Front View)...............................................................................................................................................................................................1 - 8

Main Unit (Rear View).................................................................................................................................................................................................1 - 10

Main Unit (Left View)..................................................................................................................................................................................................1 - 12

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

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

Breathing System (Top View)..................................................................................................................................................................................1 - 15

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

Anesthetic Gas Scavenging System (AGSS) (Top, Right, and Rear Views) ..............................................................................................1 - 18

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

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

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

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

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

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

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

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

Elapsed Timer................................................................................................................................................................................................................3 - 6

Patient Size ....................................................................................................................................................................................................................3 - 6

Alarm and Prompt Messages ..................................................................................................................................................................................3 - 6

Alarm Silence Icon.......................................................................................................................................................................................................3 - 7

Date and Time ..............................................................................................................................................................................................................3 - 8

Battery Status................................................................................................................................................................................................................3 - 9

Fresh Gas Flow Display.........................................................................................................................................................................................................3 - 10

Waveforms Tab .......................................................................................................................................................................................................................3 - 11

Waveform Color ...........................................................................................................................................................................................................3 - 11

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

Table of Contents

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

Spirometry Tab (A5 Only)....................................................................................................................................................................................................3 - 13

Loop Type.......................................................................................................................................................................................................................3 - 14

Show Reference ...........................................................................................................................................................................................................3 - 14

Save Loop.......................................................................................................................................................................................................................3 - 14

Review Loops Button .................................................................................................................................................................................................3 - 15

Demographics Tab.................................................................................................................................................................................................................3 - 17

Ventilation Mode Tabs..........................................................................................................................................................................................................3 - 19

Measured Values Area ..........................................................................................................................................................................................................3 - 21

System Softkeys......................................................................................................................................................................................................................3 - 22

Setup Softkey................................................................................................................................................................................................................3 - 22

Alarms Softkey..............................................................................................................................................................................................................3 - 22

Silence Softkey .............................................................................................................................................................................................................3 - 22

Capture Event (Software Version 03.02.00 and later).....................................................................................................................................3 - 22

History (Software Version 03.02.00 and later)...................................................................................................................................................3 - 22

List Trends ..........................................................................................................................................................................................................3 - 22

Graphic Trends (Software Version 03.04.00 and later) .......................................................................................................................3 - 24

Event Log ............................................................................................................................................................................................................3 - 27

Setup...........................................................................................................................................................................................................................................3 - 29

General Tab ..............................................................................................................................................................................................................................3 - 29

Display Tab ...............................................................................................................................................................................................................................3 - 31

System Tab................................................................................................................................................................................................................................3 - 34

Network Configuration..............................................................................................................................................................................................3 - 37

Service Tab................................................................................................................................................................................................................................3 - 40

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

Power Failure Alarm Test.....................................................................................................................................................................................................4 - 17

Pipeline Tests ...........................................................................................................................................................................................................................4 - 17

Pipeline Test............................................................................................................................................................................................................4 - 17

O Pipeline Test.........................................................................................................................................................................................................4 - 17

Air Pipeline Test............................................................................................................................................................................................................4 - 18

Basic Ventilation Testing......................................................................................................................................................................................................4 - 18

Cylinder Tests...........................................................................................................................................................................................................................4 - 19

Check the Cylinder Pressure....................................................................................................................................................................................4 - 19

Cylinder High Pressure Leak Test ....................................................................................................................................................................4 - 19

O Cylinder High Pressure Leak Test.................................................................................................................................................................4 - 19

Air Cylinder High Pressure Leak Test....................................................................................................................................................................4 - 19

Flow Control System Test....................................................................................................................................................................................................4 - 20

Vaporizer Tests ........................................................................................................................................................................................................................4 - 21

Vaporizer Back Pressure Test...................................................................................................................................................................................4 - 21

Manual Leak Test.........................................................................................................................................................................................................4 - 21

Vaporizer Leak Test.....................................................................................................................................................................................................4 - 21

Breathing System Tests........................................................................................................................................................................................................4 - 23

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

Table of Contents

Bellows Test...................................................................................................................................................................................................................4 - 23

Breathing System Leak Test in Manual Ventilation Status ...........................................................................................................................4 - 23

APL Valve Test...............................................................................................................................................................................................................4 - 24

Alarm Tests ...............................................................................................................................................................................................................................4 - 25

Prepare for Alarm Tests.............................................................................................................................................................................................4 - 25

Test the O

Concentration Monitoring and Alarms........................................................................................................................................4 - 25

Test the Low Minute Volume (MV) Alarm...........................................................................................................................................................4 - 26

Test the Apnea Alarm.................................................................................................................................................................................................4 - 26

Test the Continuous Airway Pressure Alarm .....................................................................................................................................................4 - 26

Test the High Paw Alarm...........................................................................................................................................................................................4 - 27

Test the Low Paw Alarm............................................................................................................................................................................................4 - 27

Preoperative Preparations ..................................................................................................................................................................................................4 - 27

Inspect the AGSS ....................................................................................................................................................................................................................4 - 28

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

Discharge / Standby Mode.......................................................................................................................................................................................5 - 3

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

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

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

O, Air, and O2 Inputs ......................................................................................................................................................................................5 - 6

Set N

Set Anesthetic Agent .................................................................................................................................................................................................5 - 6

Select the Desired Anesthetic Agent ........................................................................................................................................................5 - 7

Adjust the Concentration of 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 - 13

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

To Set VCV Mode ..............................................................................................................................................................................................5 - 14

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

To Set PCV Mode ..............................................................................................................................................................................................5 - 15

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

Pressure Support in Synchronized Intermittent Mandatory Ventilation (SIMV) .......................................................................5 - 16

Synchronized Intermittent Mandatory Ventilation–Volume Control (SIMV-VC) ......................................................................5 - 16

Synchronized Intermittent Mandatory Ventilation–Pressure Control (SIMV-PC) - A5 Only .................................................5 - 17

To Set SIMV-VC or SIMV-PC Mode .............................................................................................................................................................5 - 17

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

To Set PS Mode .................................................................................................................................................................................................5 - 18

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

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

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

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

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

Auto-zeroing the Pressure Sensors ...........................................................................................................................................................5 - 21

Volume ............................................................................................................................................................................................................................5 - 21

Gas (available with the AG module) .....................................................................................................................................................................5 - 22

Inspired O

(available without the AG module)...............................................................................................................................................5 - 22

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

Table of Contents

Spirometry (A5 Only)..................................................................................................................................................................................................5 - 22

Spirometry Loops ............................................................................................................................................................................................5 - 23

Waveform Autoscaling ..................................................................................................................................................................................5 - 24

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 - 11

Auto Alarm Limits........................................................................................................................................................................................................6 - 13

Alarm and Prompt Messages.............................................................................................................................................................................................6 - 14

Technical Alarm Messages.......................................................................................................................................................................................6 - 17

Startup Alarm Messages ...............................................................................................................................................................................6 - 17

CPU Board Runtime Alarm ...........................................................................................................................................................................6 - 19

Power Board Runtime Alarm .......................................................................................................................................................................6 - 20

Electronic Flowmeter Board Runtime Alarm .........................................................................................................................................6 - 20

Ventilator Control Board Runtime Alarm ................................................................................................................................................6 - 21

AG Module Alarm Messages ........................................................................................................................................................................6 - 23

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

Prompt Messages Displayed in Alarm Area ...........................................................................................................................................6 - 26

Prompt Messages Displayed in Pop-up Area ........................................................................................................................................6 - 27

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

Sensor 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

AGSS 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 - 11

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

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

Oxygen Sensor..............................................................................................................................................................................................................7 - 17

APL Valve........................................................................................................................................................................................................................7 - 18

PAW Gauge....................................................................................................................................................................................................................7 - 19

Bag Arm...........................................................................................................................................................................................................................7 - 20

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

Table of Contents

Absorber Canister........................................................................................................................................................................................................7 - 21

Breathing System Block.............................................................................................................................................................................................7 - 23

AGSS (Anesthetic Gas Scavenging System) and AGSS Transfer Hose......................................................................................................7 - 25

Regular Maintenance............................................................................................................................................................................................................7 - 27

AG and O2 Concentration Monitoring ......................................................................................................................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 - 3

Oxygen Enriched Environments............................................................................................................................................................................9 - 3

Wiring and PC Board Materials...............................................................................................................................................................................9 - 3

Physical Specifications..........................................................................................................................................................................................................9 - 4

Stability Configurations and Conditions........................................................................................................................................................................9 - 4

Environmental Specifications............................................................................................................................................................................................9 - 5

Electrical Specifications........................................................................................................................................................................................................9 - 6

Main Electrical Power Specifications....................................................................................................................................................................9 - 6

Battery Power Specifications...................................................................................................................................................................................9 - 6

Auxiliary Electrical Outlets........................................................................................................................................................................................9 - 6

Communication Ports................................................................................................................................................................................................9 - 7

Pneumatic Specifications ....................................................................................................................................................................................................9 - 8

Pipeline Supply (N

Cylinder Supply (N

Vaporizer Connections ..............................................................................................................................................................................................9 - 8

Drive Gas.........................................................................................................................................................................................................................9 - 8

O Automatic Cutoff................................................................................................................................................................................................9 - 8

Controls ....................................................................................................................................................................................................................9 - 8

Oxygen Ratio Controller............................................................................................................................................................................................9 - 8

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

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

Absorber Assembly............................................................................................................................................................................................9 - 9

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

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

Breathing System Temperature Controller........................................................................................................................................................9 - 10

Breathing Circuit Parameters..................................................................................................................................................................................9 - 10

Materials .........................................................................................................................................................................................................................9 - 11

Anesthetic Gas Scavenging System (AGSS)..................................................................................................................................................................9 - 11

Monitor Module......................................................................................................................................................................................................................9 - 11

AG Module .....................................................................................................................................................................................................................9 - 11

O, Air, O2) .................................................................................................................................................................................9 - 8

O, Air, O2).................................................................................................................................................................................9 - 8

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

Table of Contents

Alarms..............................................................................................................................................................................................................................9 - 13

Effect of Interfering Gas on AG Measured Value..............................................................................................................................................9 - 13

Ventilator Specifications......................................................................................................................................................................................................9 - 15

Displays and Controls Specifications ..............................................................................................................................................................................9 - 18

Electronic Controls......................................................................................................................................................................................................9 - 18

Pneumatic Controls ....................................................................................................................................................................................................9 - 18

Safety Specifications .............................................................................................................................................................................................................9 - 21

ASTM F 1208 – 89 (2005) Disclosures..............................................................................................................................................................................9 - 23

Leakage of Breathing System..................................................................................................................................................................................9 - 23

Resistance of Breathing Systems ...........................................................................................................................................................................9 - 23

Absorber Resistance..........................................................................................................................................................................................9 - 23

Absorber Capacity..............................................................................................................................................................................................9 - 23

Unidirectional Valve Opening Pressure...............................................................................................................................................................9 - 23

Data Storage (Non-Volatile) and Recording .................................................................................................................................................................9 - 24

Electromagnetic Capability ................................................................................................................................................................................................9 - 25

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

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

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

Absorbent Canister...................................................................................................................................................................................................... A - 2

Gas Cylinder Accessories ....................................................................................................................................................................................................A - 3

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

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

Mounting Accessories .........................................................................................................................................................................................................A - 4

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

Vaporizers................................................................................................................................................................................................................................. A - 5

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

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

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

Sensor...................................................................................................................................................................................................................................B - 3

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

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

Setup Menu ............................................................................................................................................................................................................................. C - 6

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

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

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

Non-Linked 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 - 5

Attention Symbols.................................................................................................................................................................................................................E - 6

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

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.

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

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

physician or other practitioner licensed by state law to use or order the use of this device.

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 WAR NIN GS , 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.

WAR NIN G — 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.

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

Introduction Warning s

Warnings

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

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

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

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

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

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

instructions.

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 60601-1-1. 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 60601-1-1.

the equipment, connecting cables, and accessories are in correct working order and operating condition.

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.

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

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

WARNING: Alarm settings should be customized according to different patient

WARNING: The physiological parameters and alarm messages displayed on the

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

monitoring.

patient.

situations. Constantly keeping the patient under close surveillance is the most reliable way for safe patient monitoring.

screen of the equipment are for the caregiver’s reference only and cannot be directly used as the basis for clinical treatment.

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

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

War nin gs Introduction

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

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

WARNING: In order to prevent electric shock, the machine (protection class I) may

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

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

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

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 IEC 60601-2-13 or ISO 8835. 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.

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.

only be connected to a correctly grounded mains connection (i.e., socket outlet with grounding contact).

utilizing high frequency electric surgery equipment, may cause burns, and is therefore not recommended in any application of this machine.

authorized service personnel.

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

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

minimum specified gas pipeline supply pressure.

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.

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

WARNING: Use extreme care while handling the absorbent as it is a caustic irritant.

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

Introduction Warning s

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

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

WARNING: All gas supplies should be of medical grade.

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

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

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

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

process as their weight may be greater than expected, based on their size and shape.

material to prevent sticking of the bellows, as these materials may enter the patient's lungs or airway, causing irritation or injury.

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.

when the machine is in use.

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

equipment. If adjacent or stacked use is necessary, the A5/A3 should be observed to ver ify no rmal op eration 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

WARNING: Pins of connectors identified with the ESD warning symbol should not

scavenging system is strongly recommended to prevent exposure of hospital personnel to the A5/A3 exhaust gases.

be touched. Connections should not be made to these connectors unless ESD precautionary procedures are used.

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

inaccurate results.

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

War nin gs Introduction

WARNING: This equipment/system is intended for use by healthcare professionals

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

WARNING: Usage of accessories with package damage may cause

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

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

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

only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the device or shielding the location.

manually powered resuscitator with mask) is available whenever the A5/A3 is in use.

biocontamination or failure. The operator should check accessory packaging for storage integrity before use.

the system and follow the on-screen prompts to perform the Leak Test and the Compliance Test. See section 4.5 (pg. 4-9) "Leak and Compliance Tests".

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.

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

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

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

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

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

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

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

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

pressure, and may burst if improperly maintained or disassembled while under pressure. Changing connectors or disassembling should be performed only by qualified personnel.

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

and the specifications of the A5/A3 System to ensure compatibility and to prevent a mismatched receiving system.

cause a loss of pressure and flow.

assemblies use the proper connectors.

nominal inlet pressure.

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

Introduction Cautions

WARNING: Reusing breathing circuits or reusable accessories that are not

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

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

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

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

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

disinfected may cause cross-contamination. Disinfect the breathing circuits and reusable accessories before use.

Ensure all components do not contain any obstructions or debris that can cause a potential hazard to the patient.

and compatible with standard 22mm male conical fittings per ASTM specifications F 1054.

electrically from the SUPPLY MAINS,not to position the Anesthesia System so that it is difficult to operate the plug.

via the I/O signal ports or replacing the oxygen cell to prevent patient leakage current from exceeding the requirements specified by the standard.

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

Cautions

CAUTION: 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.

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

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

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

CAUTION: This system operates correctly at the electrical interference levels

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

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

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

manual.

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.

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.

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.

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.

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

information contained in these Operating Instructions and must have been trained by an authorized representative.

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

Cautions Introduction

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

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

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

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

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

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

CAUTION: After each exchange of a vaporizer, perform a fresh-gas system leak

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

repaired as necessary by qualified service personnel before being returned to use.

technical specifications.

respective tests must be performed, as described in these Operating Instructions.

machine should not be operated until those faults have been corrected by a qualified service person.

before clinical use.

the A5/A3 unit.

test.

causing damage.

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

autoclaveable 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 per the manufacturer’s specification.

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.

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

Introduction Cautions

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).

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 (FiO

Auxiliary O delivered to the patient unless oxygen monitoring is used.

/Air Flow Meters. Unknown oxygen concentrations may be

%) when using the

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 transducers 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.

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

Notes Introduction

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

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

CAUTION: Turn the flow controls slowly. To avoid damaging the control valves, do

assemblies. Factors include excessive bending, crushing, abrasion, system pressures and temperatures that exceed hose ratings, and improper installation.

removal from its mounting arm as handling may be awkward due to its weight and shape.

not turn further when the flowmeter reading is outside the range. When turning a flow control knob clockwise to decrease flow, the flowmeter should reach zero before the knob reaches its most clockwise mechanical stop (Off) position. Do not turn any further when the knob has reached the Off position.

Similarly, when turning a flow control knob counterclockwise to increase flow from zero, the flowmeter reading should not indicate a change from zero until the flow control knob is turned approximately one (1) rotation counterclockwise from the Off position, and only if permitted according to the gas ratio control system.

Notes

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

NOTE: Put the equipment in a location where you can easily see the screen and

Screens may differ based on the system configuration and selected parameters.

access the operating controls.

NOTE: Keep this manual close to the equipment so that it can be obtained

conveniently when needed.

NOTE: The software was developed in compliance with IEC 60601-1-4. The

possibility of hazards arising from software errors is minimized.

NOTE: This manual describes all features and options. Your equipment may

not have all of them.

NOTE: The A5/A3 is intended to be operated with its integral Breathing

Pressure monitoring in use.

NOTE: The A5/A3 is intended to be operated with its integral Breathing

Pressure limitation devices in use.

NOTE: The A5/A3 is intended to be operated with its integral Exhaled Volume

monitoring in use.

NOTE: The A5/A3 is intended to be operated with its integral Breathing System

integrity Alarm System in use.

NOTE: The A5/A3 is intended to be operated with its integral Continuing

Pressure Alarm in use.

NOTE: The A5/A3 is intended to be operated with its integral O

use.

NOTE: The A5/A3 is intended to be operated with an external CO

complying with ISO 21647. Connection to the CO via a sample line from the patient circuit.

monitoring in

monitor

monitor should be

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

Introduction Notes

NOTE: The Anesthesia Vapor Delivery Device is to be used with an Anesthetic

NOTE: Continuously monitor the anesthetic agent concentration when using

NOTE: Check the liquid level of the anesthetic agent before and during all

NOTE: The A5/A3 System is designed to be equipped with an anesthetic vapor

NOTE: The A5/A3 battery supply is not a user serviceable component. Only an

NOTE: Areas designated for the servicing of oxygen equipment shall be clean,

NOTE: Opening the cylinder valve quickly may cause unexpected pressure

Agent Monitor complying with ISO 21647. Connection to the Agent monitor should be via a sample line from the Patient Circuit.

the Anesthesia System to ensure accurate output of the anesthetic agent.

operations. When the liquid level is below the warning line, more anesthetic agent needs to be added. Refer to the vaporizer Instructions For Use for filling the vaporizer and other information.

delivery device that complies with ISO 11196.

authorized service representative can replace the battery supply. If the system is not used for an extended period, contact a service representative to have the battery supply disconnected. The batteries may be subject to local regulations regarding disposal. At the end of the battery life, dispose of the battery supply in accordance with local regulations.

free of oil and grease, and not used for the repair of other equipment.

differentials and create a potential for fire or explosion arising from oxygen pressure shocks. Open and shut the cylinder valve slowly.

NOTE: Accuracy of the flowrate may be affected by varying inlet pressure,

NOTE: The power device, terminal units and pipeline system can be supplied

NOTE: Regional or national regulations that apply to manufacturers of

NOTE: For the method of connecting A5 to external monitor or other devices,

NOTE: The A5 can be equipped with one scavenger system to provide the best

varying outlet resistance, or varying ambient temperature.

by one or several different manufacturers.

medical devices can exist.

please see Anesthesia Machine Bracket Installation Instructions.

match with the hospital’s waste-gas disposal system. The scavenger system shall comply with ISO 8835-3.

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

Warranty Statements Introduction

Warranty Statements

Mindray DS USA, Inc. warrants that components within the anesthesia system will be free from defects in workmanship and materials for the number of years shown on the invoice. Under this extended warranty, Mindray DS USA, Inc. will repair or replace any defective component at no charge for labor and/or materials. This extended warranty does not cover consumable items such as (but not limited to) batteries and external cables.

Calibration may be performed without the need to disassemble the instrument. It is the responsibility of the purchaser to perform calibration as necessary, in accordance with the instructions provided in this manual.

Recommended preventative maintenance, as prescribed in the Maintenance section of this manual, is the responsibility of the user, and is not covered by this warranty.

Except as otherwise provided herein, the terms, conditions, and limitations of Mindray DS USA, Inc.’s standard warranty will remain in effect.

Mindray DS USA, Inc. warrants that its products will be free from defects in workmanship and materials for a period of one (1) year from the date of purchase except that disposable or one-time use products are warranted to be free from defects in workmanship and materials up to a date one year from the date of purchase or the date of first use, whichever is sooner. This warranty does not cover consumable items such as, but not limited to, batteries, external cables, O absorbents, breathing circuits, hoses, or mounts.

sensors, CO2

Mindray DS USA, Inc. will not be liable for any incidental, special, or consequential loss, damage, or expense directly or indirectly arising from the use of its products, liability under this warranty and the buyer’s exclusive remedy under this warranty is limited to servicing or replacing at Mindray DS USA, Inc.’s option at the factory or at an authorized distributor, any product which shall under normal use and service appear to the Company to have been defective in material or workmanship.

No agent, employee, or representative of Mindray DS USA, Inc. has any authority to bind Mindray DS USA, Inc. to any affirmation, representation, or warranty concerning its products, and any affirmation, representation or warranty made by any agent, employee, or representative shall not be enforceable by buyer.

This warranty is expressly in lieu of any other express or implied warranties, including any implied warranty or merchantability or fitness, and of any other obligation on the part of the seller.

Damage to any product or parts through misuse, neglect, accident, or by affixing any non-standard accessory attachments or by any customer modification voids this warranty. Mindray DS USA, Inc. makes no warranty whatever in regard to trade accessories, such being subject to the warranty of their respective manufacturers.

A condition of this warranty is that this equipment or any accessories which are claimed to be defective be returned when authorized, freight prepaid to Mindray DS USA, Inc., Mahwah, New Jersey

07430. Mindray DS USA, Inc. shall not have any responsibility in the event of loss or damage in transit.

Disclaimers

Product Improvements — Mindray DS USA, Inc. retains the right to modify the machine and/or operating instructions without prior notification. These operating instructions explain all features of the A5/A3 System and are correct at time of manufacture. Instructions and models produced at a later stage, may contain improvements or modifications that were not included in previous models.

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

Introduction Phone Numbers and How To Get Assistance

Phone Numbers and How To Get Assistance

A network of service representatives and factory-trained distributors is available. Prior to requesting service, perform a complete operational check of the instrument to verify proper control settings. If operational problems continue to exist, contact the Service Department at (800) 288-2121, ext: 8116 for Technical Support or (201) 995-7875 for assistance in determining the nearest field service location.

Please include the instrument model number, the serial number (located on the back of the A5/A3), and a description of the problem with all requests for service.

Warranty questions should be directed to a local representative. A list of offices, along with their phone numbers, is provided at the end of this manual.

NOTE: Upon request, calibration instructions or other information will be

provided to assist the user’s appropriately qualified technical personnel in repairing those parts of the A5/A3 which are designated as repairable.

Manufacturer’s Responsibility

The effects on safety, reliability, and performance of the equipment are the manufacturer’s responsibility only if:

a. assembly operations, extensions, readjustments, modifications or repairs are carried out

by authorized personnel; and

b. the electrical installation of the relevant room complies with the appropriate

requirements; and

c. the equipment is used in accordance with the instructions for use

Symbols

The following table provides descriptions of symbols that are used on the device and/or within this manual.

SYMBOL DESCRIPTION SYMBOL DESCRIPTION

Attention, Consult Accompanying Documents / Refer to Manual

Defibrillator proof type BF equipment

Electrical: Alternating Current (AC)

Electrical: Equipotentiality

Environment: Tem per atu re R an ge

Environment: Humidity Range

Environment: Pressure Range

Gas Cylinder

Electrical: Fuse or circuit breaker

Electrical: Input Output

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

Gas Inlet

Gas Outlet

Symbols Introduction

Electrical: Internal Battery

Electrical: Light

Electrical: Power On

Electrical: Power Standby

Electrical: Protective Earth (Ground)

Gas Flow: Flow Control

Gas Flow: Maximum

Gas Flow: Minimum

Gas Flow Total

Gas:

Flush

Electrical:

WEEE (Waste of Electrical and Electronic Equipment) Marking.

Sensor Connector

Separate treatment from general waste at end of life.

Identifier: Manufacturer

Gas Pipeline Connection

Identifier: Manufacturer’s Reference/Catalog

Material: Polyphenyl-sulfone

Number

Identifier: Serial Number Indicator

Lock/Unlock: Direction

Lock/Unlock: Lock

Lock/Unlock: Unlock

No Heavy Objects Do Not Crush

Material: Polysulfone

Tou ch pa d

Manual ventilation via Breathing Bag

Automatic Ventilation

Water Trap

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

Introduction Symbols

134°C

Autoclavable

Not Autoclavable

Caution: Hot

Water Drain

Peel off the work surface protective film

Canister opened

Do Not Oil

Filter Access

Direction of flow

Drawer weight limit

Conforms to UL std 60601-1, IEC std 60601-2-13 Certified to CAN/CSA std C22.2 No

601.1, No 60601-2-13

Canister closed

Maximum pressure of ACGO separate outlet

Battery supply fully charged. AC power connected and powering system.

Battery supply partially charged. AC power connected, charging battery supply, and power system.

Battery supply fully charged and powering system. AC power not connected.

Battery supply partially charged and powering system. AC power not connected.

Alarm Icon

Alarm Silence Icon

Low priority message

Medium priority message

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

Battery supply low charged and powering system. Recharging recommended. AC power not connected.

High priority message

Battery supply not installed.

Breathing System Warmer Off

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

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

1.0

Product Description

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

Physical Views .............................................................................................................................................................................................1-8

A5/A3™ Operating Instructions 046-003777-00 1 - 1

General System Overview Product Description

1.1 General System Overview

1.1.1 General Description

The A5/A3 Anesthesia System is a device intended to administer, continuously or intermittently, a general inhalation anesthetic to a patient, and to maintain a patient's ventilation. The A5/A3 also provides for ventilatory monitoring of the patient. The anesthesia system is intended to be used in the patient environment.

The A5/A3 Anesthesia System consists of a main unit (includes an anesthetic ventilator and flowmeter monitor assembly) and a detachable breathing system. The applied part of the anesthesia system are breathing tubes and masks.

The A5 Anesthesia System provides the following ventilation modes:

• Volume Control Ventilation (VCV), which includes the Pressure Limit Ventilation (PLV) function

• Pressure Control Ventilation (PCV) with/without Volume Guarantee (VG) ventilation mode

• Synchronized Intermittent Mandatory Ventilation (SIMV ) with VC mode (with/without PS option)

• Synchronized Intermittent Mandatory Ventilation (SIMV) with PC mode (with/without PS option)

• Pressure Support (PS) ventilation mode

• Spontaneous ventilation in Manual mode with APL fully open

• Manual Ventilation through the use of a breathing bag

• Cardiac Bypass mode

The A3 Anesthesia System provides the following ventilation modes:

• Volume Control Ventilation (VCV), which includes the Pressure Limit Ventilation (PLV) function

• Pressure Control Ventilation (PCV)

• Synchronized Intermittent Mandatory Ventilation (SIMV ) with VC mode (with/without PS option)

• Pressure Support (PS) ventilation mode

• Spontaneous ventilation in Manual mode with APL fully open

• Manual Ventilation through the use of a breathing bag

Electronic PEEP is available in all automatic ventilation modes. User control over inspiratory flow (Tslope) is possible in PCV, SIMV, and PS modes. Automatic fresh gas compensation limits the effect on the patient ventilation from changes in fresh gas flow rate by the operator. The traditional bellows system is driven by oxygen and makes patient disconnections clearly visible.

The A5/A3 Anesthesia System provides the following common functions:

• Automatic leak detection

• Circuit gas leakage compensation and automatic compliance compensation

• Cylinder and central pipeline gas supply connections available for gas input

• Electronically displayed flowmeter and electronically adjustable PEEP

• Electronic timer to display the duration between the start and end of an operation

• Work table light

• Mounting rails to connect an external patient monitor

•Network-ready

• Flow trigger mode available for PS and SIMV

• Auxiliary O

•Active AGSS

O cutoff

•N

•Vaporizer

and air supply

1 - 2 046-003777-00 A5/A3™ Operating Instructions

Product Description General System Overview

• Total flow rotameter

•AG module

1.1.2 Key Features

FEATURE DESC RIPTION

Display 15 inch color LCD with touchscreen

Navigation Graphical user interface for easy navigation

Ventilation Manual and automatic ventilation modes and monitoring: VCV, SIMV-VC,

PCV, SIMV-PC (A5 only), PS, and Manual

Fresh Gas Delivery Continuous and intermittent anesthesia flow, total flow rotameter,

virtual dual flow tubes, electronically displayed on screen for ease of use 3 cylinder mount locations on rear

Breathing System Heated, adjustable swivel, side hose ports, single turn APL valve

Ergonomics Large stainless steel work surface

Adjustable Breathing System block via swivel up to 50 degrees

Electronic PEEP Positive End Expiratory Pressure (PEEP) is set and controlled electronically.

Clear Data Display Two large waveforms for pressure and flow or

Spirometry Loops (A5 only)

USB Mouse Support The A5/A3 system supports a wired USB mouse, which can be plugged into

one of the two SB ports at the rear of the unit. A cursor appears when the mouse is plugged. The cursor disappears if the user touches the screen or after 15 seconds of mouse inactivity.

1.1.3 Fresh Gas Dosing

The A5/A3 fresh gas dosing subsystem offers the following features:

• Virtual On-Screen dual flow tube and numerical readouts to display the O

• A knob guard to prevent inadvertent movement of the flow control knobs

• Gas supply gauges to indicate the gas pipeline supply pressures and gas cylinder pressures

• Mechanical total flowmeter to display the combined flow of O

•An O

• A single combined output of auxiliary O

Safety systems within the A5/A3 work to prevent hypoxic mixtures from being delivered to the patient. Nitrous oxide will not be delivered unless oxygen flow is present. A pneumatic safety system assures that at least 21% O is placed in the standby mode, O

WARNING: Ensure that both O2 and N2O flow controllers are turned OFF fully at the

All A5/A3 units are designed to maintain a safe O2:N2O ratio by allowing nitrous oxide to be set to a flow rate that is proportional to a previously adjusted flow of oxygen. The N flow of O to maintain oxygen flow at its previously set level when N

flush button

start and at the end of each case.

so that a safe ratio of no less than 21% oxygen can be maintained. The A5/A3 is designed

A3: The USB mouse can serve as a backup to the touchscreen. A5: The USB mouse can serve as a backup to both the touchscreen and touchpad.

, N2O, and Air flows

, Air, and N2O

and Air with flowmeters

is present when setting mixtures of O2 and N2O. Additionally, if the A5/A3

fresh gas flow is not available.

O flow is limited by the

O is decreased.

A5/A3™ Operating Instructions 046-003777-00 1 - 3

General System Overview Product Description

When adjusting N2O and O2 flow rates, always adjust the oxygen flow first to enable the nitrous oxide flow. To add N2O to the fresh gas flow, open the N2O flowmeter valve, but only after opening the O2 flowmeter valve.

1.1.4 Flow Control

Flow Control needle Valve and Knob:

Three independent flow control knobs allow setting the input flow rates of N fresh gas flow.

O Automatic Cutoff:

An N2O automatic cutoff valve stops the flow of N2O if O2 flow is less than 200 mL/min.

Pressure Loss Alarm:

An O2 pressure loss alarm annunciates when oxygen pressure is less than 220 kPa (32 psi).

Oxygen Ratio Controller:

An O

ratio controller ensures that there is always at least 21% oxygen concentration in the fresh flow

when N

O is fully open.

O, Air, and O2 into the

1.1.4.1 Flow/Pressure Sensing

The Breathing System block contains patient flow and pressure sensors to measure inspiratory flow, expiratory flow, and inspiratory pressure. These sensors enable spirometry as well as standard pressure and flow monitoring.

1.1.5 Vaporizer Mounting

The A5/A3 contains a 2-position Selectatec-type vaporizer mounting system to enable anesthetic agents to be introduced into the fresh gas flow. The mounting system adapts vaporizers with interlock, which permits only one agent at a time to be administered. Lighting above the vaporizers enables them to be seen in a darkened environment. A maximum of two vaporizers can be attached for use at any one time. Halothane, Enflurane, Isoflurane, Desflurane, and Sevoflurane vaporizers can be used.

For the A5 model, a third, non-functional vaporizer parking spot on the side of the unit is provided as part of the standard configuration.

1.1.6 Anesthesia Ventilator

The A5/A3 ventilator offers multiple ventilation modes: Volume Control Ventilation (VCV), Synchronized Intermittent Mandatory Ventilation-Volume Control (SIMV-VC), Pressure Control Ventilation (PCV), Pressure Support (PS) ventilation, and Manual ventilation.

The A5 offers additional ventilation modes, which include Pressure Control Ventilation (PCV) with and without Volume Guarantee (VG), and Synchronized Intermittent Mandatory Ventilation-Pressure Control (SIMV-PC).

1.1.7 Breathing System

A portion of the patient circuit is integrated into an assembly block called the Breathing System. The system contains a temperature controller, which warms the block to a temperature of 35ºC typical at 20ºC ambient temperature to limit the formation of water condensate. The Breathing System can be swiveled horizontally up to 50 degrees for user convenience.

The breathing system provides access to the APL valve and breathing bag along with a view of the airway pressure gauge. The APL valve has a single turn knob that provides a clear view of the manual breathing pressure setting. The absorber assembly incorporates a cam-lock device that opens and closes to provide access to the absorber canister. Either a CO used. Two water traps that can be drained are located on the CO breathing system block.

1 - 4 046-003777-00 A5/A3™ Operating Instructions

absorbent Pre-Pak or loose fill can be

absorber assembly and on the

Product Description General System Overview

NOTE: Operating the A5/A3 with a full water trap in the breathing system

Two (2) flow sensors in the breathing system measure inspired and expired gases for control and monitoring. Inspired oxygen concentration is monitored via a fuel-cell type sensor. Breathing pressure is monitored with both a PAW gauge (mechanical) and electronic gauge. The breathing system can be swiveled for ease of positioning. A leak test port is provided to allow for leak testing during startup.

The main pneumatic components of the Breathing System are as follows:

• Inspiratory Valve (passive)

• Expiratory Valve (passive)

• Airway Pressure Limiting Valve (APL)

• Connection for O

•CO2 Absorber Assembly

• Bellows Assembly

• Auto/Manual bag switch

• Bag arm

•PAW Gauge

The Breathing system connects to the A5/A3 main unit through the following ports:

block does not allow the water to condense appropriately. The trap should be removed and emptied when filled with water.

Sensor

• Drive gas port, designed for use with oxygen as the drive gas

• Fresh gas port

• Exhaust gas port

• Flow sensor pressure transmission pipeline port

The Breathing System contains the following ports for end-user connections:

• Inspiratory port for Inspiratory hose of patient breathing circuit

• Expiratory port for Expiratory hose of patient breathing circuit

• Manual Breathing Bag Arm

• Connection for the O

•Water trap

• Leak test port for sealing the breathing circuit during leak testing

cell

1.1.8 Anesthetic Gas Scavenging System (AGSS)

The A5/A3 includes a waste gas scavenger that attaches to the side rail mount on the system. The A5/ A3 provides a port for the connection of the waste line from an anesthetic gas monitor.

1.1.9 Power Management / Battery Supply

The advanced power management system of the A5/A3 provides AC power for main system functions while charging the system’s internal battery supply. During AC power failure, the A5/A3 will operate on battery power for a minimum of 75 minutes with one (1) new battery installed (A3) or 150 minutes with two (2) new batteries installed (A5). See ‘‘Battery Power Specifications’’ on page 9-6.

A5/A3™ Operating Instructions 046-003777-00 1 - 5

General System Overview Product Description

A recessed main switch is provided to power the system On and to put the system on power standby where the battery supply continues to charge as necessary when the A5/A3 is plugged into an external power source. The main switch also stops the O2 fresh gas supply when the A5/A3 is placed in Power Standby mode.

Auxiliary AC outlets on the rear of the machine operate independently of the main switch position. The A5 provides four (4) auxiliary AC outlets; the A3 provides three (3) auxiliary AC outlets. The auxiliary AC outlets are not powered when operating the A5/A3 on the internal battery supply.

NOTE: Use the battery supply in the A5/A3 at least once every month to

extend battery life. Charge the battery supply before its power capacity is depleted.

NOTE: Inspect and replace the battery supply at regular service intervals.

NOTE: The operating time of a battery depends on equipment configuration

NOTE: In case of battery failure, contact Mindray service personnel for battery

Long-term battery life depends on how frequent and how long the battery supply is used. For a properly maintained and stored lithiumion battery, its long-term life expectancy is approximately three (3) years. In more aggressive usage, life expectancy can be shortened. Replacing lithium-ion batteries every three (3) years is recommended.

and operation.

supply replacement.

The A5/A3 Anesthesia System is designed to operate on battery power whenever AC power is interrupted. When the A5/A3 is connected to an AC power source, the battery supply is charged whether or not the A5/A3 is turned on. In case of power failure, the A5/A3 will automatically switch to run from the internal battery supply. When AC power source is restored within the specified time, the battery supply begins recharging, and power is switched from battery to AC automatically to ensure continuous system use.

When power is lost for less than or equal to 60 s, the alarm settings prior to the power loss shall be restored automatically.

The on-screen battery symbol indicates the battery status. See FIGURE 1-1:

PART(S) DESCRIPTION

Battery supply is fully charged. AC power is connected. The A5/A3 is being powered by AC power. The solid portion represents the current charge level of the batteries in proportion to its maximum charge level.

Battery supply is partially charged. AC power is connected and charging battery supply. The A5/A3 is being powered by AC power.

Battery supply is fully charged. AC power is not connected. The A5/A3 is being powered by internal battery supply.

1 - 6 046-003777-00 A5/A3™ Operating Instructions

Product Description General System Overview

PART(S) DESCRIPTION

Battery supply is partially charged. AC power is not connected. The A5/A3 is being powered by internal battery supply.

Battery supply is low charged. Batteries need to be charged immediately to operate as a safe power backup. AC power is not connected. The A5/A3 is being powered by internal battery supply.

Battery supply is not installed.

FIGURE 1-1 Battery Status

If the battery capacity is too low, power supply failure will result. A high-level alarm will be triggered and the message Low Battery Voltage! will be displayed in the technical alarm area. In this case, apply AC power to the A5/A3 Anesthesia System to resume operation and charge the battery supply.

1.1.10 Workplace Ergonomics

The A5/A3 is a full-featured anesthesia delivery work station. The raised perimeter of its stainless steel work surface retains items that might otherwise roll or slide off its edge. The work surface light has high and low brightness settings. The wrap-around handle enables fine positioning of the machine. Three (3) large drawers are available for storage. All drawers can be locked with a key. Rail mounts on both sides of the machine enable mounting of patient monitors and most standard attachment arms for other devices. For the A5, a non-slip footrest and central brake are provided. For the A3, a non-slip footrest and individual caster brakes are provided. The top shelf can be used to mount additional equipment.

The operator of the A5/A3 should be positioned in front of the monitor at a comfortable distance to view all displayed waveforms, text, and controls.

1.1.11 Hook

There is a hook located on the front of the breathing system that can be used to hang the tubes of the breathing circuit.

A5/A3™ Operating Instructions 046-003777-00 1 - 7

Physical Views Product Description

1.2 Physical Views

1.2.1 Main Unit (Front View)

A11

A13

A10

A12

A14

A17

A18

A19

A20

A21

A22

A23

A24

A25

A26

A27

A28

A15

A16

FIGURE 1-2 Main Unit (Front View)

PART(S) DESCRIPTION

A1 Alarm Light Illuminates red, yellow, or cyan during an alarm condition

A2 LCD Touchscreen Display /

System Interface

A3 Auxiliary O

A4 Auxiliary O

/Air Flowmeters Auxiliary O2/Air Flowmeters for auxiliary O2/Air output

/Air Gas Outlet Nozzle (barbed connector) for auxiliary O2/Air output.

to indicate the alarm priority. Red = high priority, Yellow = medium priority, cyan = low priority, off = no alarm condition.

See section ‘‘System Interface’’ on page 3-1

Combines the auxiliary O output of O upon the O

only, Air only, or O2/Air blend, depending

and Air flow adjustments.

/Air flowmeters into a single

1 - 8 046-003777-00 A5/A3™ Operating Instructions

Product Description Physical Views

PART(S) DESCRIPTION

A5 Auxiliary O2 Gas Power Outlet

(A5 only)

A6 Flow Control Knobs N

A7 Pressure Gauges (pipeline) Indicate the pressure at pipeline inlets for O

A8 Pressure Gauges (cylinder) Indicate the pressure at cylinder inlets for O

A9 Total Flow Meter Displays the combined flow rate of O

A10 O

A11 O

Sensor Electrical Port Connects the O2 sensor cable on the breathing system to

Flush Button Provides high flow O2 to the inspiratory limb of the

A12 Touchpad

High pressure O2 outlet (DISS connector) for connecting external devices such as a jet ventilator.

O, Air, and O2 gas dosing. Turn each knob

counterclockwise to increase flow.

, Air, and N2O.

the main A5/A3 unit.

breathing system.

Allows alternate control of the touch screen. Pull out to use.

(A5 only)

A13 AGSS Anesthetic Gas Scavenging System

A14 Wheel Lock

(A5 only)

Locks or releases the brakes for all wheels when depressed. A wheel lock indicator displays red to indicate that the wheels are locked. Green indicates unlocked.

A15 Wheel Lock Indicator

(A5 only)

Displays a lock symbol in red background to indicate the wheels are locked, or an unlock symbol in green background to indicate the wheels are unlocked.

A16 Wheels Casters to enable the A5/A3 System to be moved. Casters

on the A5 lock via a central brake. Casters on the A3 lock via individual locking levers on each caster.

A17 Work Light Located under the top shelf to illuminate the work level

shelf and allow the user to read the vaporizer dial setting in a darkened room.

A18 Work Light Switch Turns on/off the work light. Three settings: Off, Low, and

High. The user can turn on the work light only when the main power switch is turned on.

A19 Vaporizer Mounting Manifold /

Mounting Bar

An interface for two Selectatec-type vaporizers to mount in this location. Bar holds two vaporizers. An interlock within the vaporizers provides for use of one vaporizer to deliver one agent at a time.

A20 Vaporizer Mount Valve

Vaporizer index and outlet ports.

Cartridge

A21 Vaporizer Parking Spot Holds a non-functional vaporizer for user convenience.

(A5 standard, A3 optional)

A22 Vaporizer Locking Device Vaporizer locking mechanism to secure against accidental

disconnection

A23 AC Status LED Illuminated when the system is connected to an AC power

source.

A24 Battery Charging LED Illuminated when the battery supply is charging.

A25 Main Power Switch Switch to turn the system on or off.

A26 Handle Metal bar used to assist moving the A5/A3

A27 Key lock Key and lock for securing the drawers

A28 Storage Drawers Drawers (3) for storage (lockable)

A5/A3™ Operating Instructions 046-003777-00 1 - 9

Physical Views Product Description

1.2.2 Main Unit (Rear View)

B13

B10

B11

B12

B14

FIGURE 1-3 Main Unit (Rear View)

PART(S) DESCRIPTION

B1 Circuit Breakers Breakers for each auxiliary outlet

A5: 3 A each (quantity 4), 10 A total (quantity 1) A3: 3 A each (quantity 3)

B2 Mains Inlet Connects the mains power cord

B3 Exhaust Fan Forces air to cool electronics and prevent buildup of O

concentration. Do not block.

1 - 10 046-003777-00 A5/A3™ Operating Instructions

Product Description Physical Views

PART(S) DESCRIPTION

B4 Communication Ports SP1, DP1, CS1, SB1, SB2 (See section 9.6.4 (pg. 9-7)

"Communication Ports".)

CAUTION: Do not connect any

devices to the SB ports other than Mindray approved USB storage devices and a supported USB mouse (see ‘‘N etworking and USB Storage’’ on page A-4).

B5 Auxiliary AC Outlets A5: Additional devices up ‘to a total maximum power of 10

amps can be connected to four (4) outlets.

A3: Additional devices up to a total maximum power of 9 amps can be connected to three (3) outlets.

The A5 outlets are covered with two (2) metal plates, the A3 outlets are covered with one (1) metal plate, and require a tool to access. Only authorized personnel can access these outlets.

B6 Equipotential stud / lug Provides a ground point

B7 Hooks Allows user to hang or wrap cords

B8 Cylinder Supply Connections Interface connectors to high pressure supply tanks (O

and N

B9 Gas Pipeline Supply

Connections

Connections for O

, Air, and N2O from a pipeline gas supply

, Air,

B10 Sample Line Exhaust Gas Inlet Inlet for exhaust gas from gas module. Merges with the

AGSS connector that connects to the AGSS.

B11 AGSS Connector Connects the AGSS or waste gas disposal system

B12 AGSS Anesthetic Gas Scavenging System

B13 Cylinders Supply tanks (E-size) containing high pressure O

O to act as backup supply if the pipeline pressure is

removed. Note: Tanks not supplied by Mindray.

, Air, and

B14 AGSS Transfer Hose Routes exhaust gases from main unit to scavenger.

A5/A3™ Operating Instructions 046-003777-00 1 - 11

Physical Views Product Description

1.2.3 Main Unit (Left View)

FIGURE 1-4 Main Unit (Left View)

PART(S) DESCRIPTION

C1 Auxiliary O

Flowmeters

C2 Auxiliary O

Outlet

C3 Auxiliary O

Power Outlet

/Air

/Air Gas

Gas

Auxiliary O2/Air Flowmeters for auxiliary O2/Air output

Nozzle (barbed connector) for auxiliary O2/Air output. Combines the auxiliary O

High pressure O devices such as a jet ventilator.

/Air flowmeters into a single output.

outlet (DISS connector) for connecting external

(A5 only)

C4 Rail Mount Enables mounting of patient monitors and most standard attachment

arms for other devices. Rail mounts are on both left and right sides of the A5/A3.

C5 Module slot AG module can be inserted into the slot and identified.

1 - 12 046-003777-00 A5/A3™ Operating Instructions

Product Description Physical Views

1.2.4 Main Unit (Right View)

FIGURE 1-5 Main Unit (Right View)

PART(S) DESCRIPTION

D1 Vaporizer Mounting

Manifold / Mounting Bar

D2 Key Lock Key and lock for securing the drawers

D3 Storage Drawers Drawers (3) for storage (lockable)

D4 Rail Mount Enables mounting of patient monitors and most standard

attachment arms for other devices. Rail mounts are on both left and right sides of the A5/A3.

A5/A3™ Operating Instructions 046-003777-00 1 - 13

Physical Views Product Description

1.2.5 Main Unit (Top View)

Rear

Front

FIGURE 1-6 Main Unit (Top View)

PART(S) DESCRIPTION

E1 Top Shelf Top level surface

E2 Work Level Shelf Work Level surface (stainless steel)

E3 Handle Wrap-around metal bar used to assist moving the A5/A3

E4 Mounting Holes Allows mounting of optional equipment to the top shelf

device

(e.g., DPM6 and DPM7 mounting plates and kits. See section A.7 (pg. A-4) "Mounting Accessories")

1 - 14 046-003777-00 A5/A3™ Operating Instructions

Product Description Physical Views

1.2.6 Breathing System (Top View)

F10

FIGURE 1-7 Breathing System (Top View)

PART(S) DESCRIPTION

F1 Bellows (including bellows

F2 PAW Gauge

dome)

F3 Expiratory Limb Exhaled breathing circuit connection

F4 Inspiratory Limb Inhaled breathing circuit connection

F5 Expiration Valve Allows flow of expiratory gas from the patient to the re-

F6 Inspiration Valve Allows flow of inspiratory gas to the patient, and prevents

F7 Bag Arm Provides the interface to the manual ventilation bag

F8 O

F9 APL (Airway Pressure

Sensor Cable Assembly An electro-galvanic fuel cell device to measure the

Limiting) Valve

Bellows that separates the breathing system gases from the oxygen drive gas

Indicates the patient airway pressure

breathing system, and prevents reverse flow.

reverse flow.

concentration of O cable, O

cell cover, and O2 sensor.

. The assembly is composed of the O2

Rotary regulator for setting the breathing system pressure limit during manual ventilation. Its scale shows approximate pressure. Set to SP during Spontaneous breathing.

A5/A3™ Operating Instructions 046-003777-00 1 - 15

Physical Views Product Description

PART(S) DESCRIPTION

F10 Auto/Manual Bag Switch Enables switching between Automatic and Manual

ventilation modes

The bellows dome is a transparent cover with graduation marks from 300 to 1500 mL. These marks are for reference only. Tidal volume (Vt) should be read exclusively from the display of the user interface. Delivered Vt is a combination of bellows displacement and fresh gas flow.

The APL valve and Paw gauge numerics are for reference only. Calibrated patient airway pressure is displayed on the user interface.

1 - 16 046-003777-00 A5/A3™ Operating Instructions

Product Description Physical Views

1.2.7 Breathing System (Left View)

FIGURE 1-8 Breathing System (Left View)

PART(S) DESCRIPTION

G1 CO

G2 Condensate Drain Valve Turn counter-clockwise (looking from bottom) to drain water

G3 Absorber Canister Lock Lever-type locking mechanism to lock (horizontal position) or

G4 Water Trap Accumulates condensate from the breathing system. Must be

G5 Absorber Bypass Assembly Maintains pressure in the breathing circuit when changing

G6 Hook Hang the tubes of the breathing system.

Absorber Canister Container for CO2 absorbent material loose fill or Pre-Paks)

collected in the absorber canister.

unlock (vertical position) the absorber canister from the canister assembly.

removed and emptied periodically. To remove, turn clockwise (looking from top).

the sodalime contents in the CO

absorber canister.

A5/A3™ Operating Instructions 046-003777-00 1 - 17

Physical Views Product Description

1.2.8 Anesthetic Gas Scavenging System (AGSS) (Top, Right, and Rear Views)

Top Vie w

Right View

Max

Min

FIGURE 1-9 AGSS (Top, Right, and Rear Views)

Rear View

Max

Min

PART(S) DESCRIPTION

H1 Mounting Rail Attachment Allows the AGSS to be mounted on the side rail. Contains a

H2 Flow Adjust Knob Turn clockwise or counter-clockwise to adjust the flow in the

H3 Exhaust Port Exhaust port to the hospital’s waste gas scavenging system

H4 Inlet Port Intake for exhaust gases from the breathing system. An AGSS

H5 Float Indicates exhaust flow. Adjusted by turning the Flow Adjust

thumbscrew that must be tightened against the mounting rail.

AGSS until the float is between Min and Max marks.

transfer hose connects the Inlet and AGSS ports (see FIGURE 1-3) to transfer the exhaust gases.

Knob (H2) until the float is between the Min and Max marks.

1 - 18 046-003777-00 A5/A3™ Operating Instructions

2.0

Installation

A5/A3™ Operating Instructions 046-003777-00 2 - 1

Installation

WARNING: This equipment must be installed by a factory authorized

representative.

WARNING: Continuous use of desiccated sodalime may endanger patient safety.

Adequate precautions should be taken to ensure that the sodalime in the CO

absorbent canister does not become desiccated. Turn off all

gases when finished using the system.

WARNING: When electrosurgical equipment is used, keep the electrosurgical leads

away from the breathing system, the O A5/A3 Anesthesia System. Keep available backup manual ventilation

sensor, and other parts of the

and a respirator with mask in case the electrosurgical equipment prevents safe use of the ventilator. Ensure the correct operations of all life support and monitoring equipment.

WARNING: Do not use masks or breathing tubes that are antistatic or conductive.

They can cause burns if they are used near high frequency electrosurgical equipment.

WARNING: This A5/A3 Anesthesia System has waste gas exhaust ports. The

operator of the machine should pay attention to the disposal of the residual breathing gas scavenged.

CAUTION: The operational environment and the power source of the equipment

must comply with the requirements as specified in the A5/A3 ‘‘Product Specifications’’ on page 9-1

2 - 2 046-003777-00 A5/A3™ Operating Instructions

Installation Unpacking

2.1 Unpacking

When the A5/A3 Anesthesia System is delivered, IMMEDIATELY inspect the box for any damage.

a. If there is NO damage and ALL tip indicators on the box exterior are intact, then sign and

date the bill of lading or airway bill to indicate safe receipt of the A5/A3.

b. If there is DAMAGE or ANY of the tip indicators on the box exterior have been activated,

then conditionally accept the delivery and clearly describe the damages on the bill of lading or airway bill. BOTH the carrier and recipient must sign and date the bill of lading or airway bill. Save all damaged factory packaging until further instructed by Mindray. The receiver should immediately contact Mindray Customer Service at (800) 288-2121 or (201) 995-8000.

A5/A3™ Operating Instructions 046-003777-00 2 - 3

Initial Setup Installation

2.2 Initial Setup

The initial setup of the A5/A3 Anesthesia System must be performed by an authorized Mindray service representative. Please contact Mindray Technical Support for any additional assistance.

NOTE: The A5/A3 is intended to be operated with an external CO2 monitor

complying with ISO 21647. Connection to the CO2 monitor should be via a sample line from the patient circuit.

2 - 4 046-003777-00 A5/A3™ Operating Instructions

Installation Install the Vaporizer

2.3 Install the Vaporizer

CAUT ION: O nly vap orizers wit h Selectate c Inter lock Sys tems may be u sed wit h the

A5/A3 unit.

WARNING: Use vaporizers compliant to ISO 8835-4. See section A.9 (pg. A-5)

"Vaporizers". Refer to the vaporizer manufacturer’s Instructions For Use for mounting, filling, or draining the vaporizer and other information.

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

NOTE: The barometric pressure may differ from the calibration pressure of the

process as their weight may be greater than expected, based on their size and shape.

anesthetic vaporizer. This may cause an inaccurate output of the anesthetic agent. The operator should continuously monitor the concentration of anesthetic agent during system use to determine if the outputted concentration is accurate.

FIGURE 2-1 shows the location of the vaporizer mounting system on the A5/A3 unit.

Vaporizer mounts for two

inline vaporizers

A5 only: Additional

vaporizer mount for one

inactive vaporizer

FIGURE 2-1 Location of Vaporizer Mounting System

1. If replacing and removing the vaporizer, lift each vaporizer straight up off the manifold. Do

not pull the vaporizer forward. Do not rotate the vaporizer on the manifold.

2. Align the new vaporizer over the valve cartridges of the mounting bar, slightly tilting back

the vaporizer. Hang the vaporizer on the mounting bar as shown in FIGURE 2-2. Ensure that the locking mechanism handle is in the unlocked position. Ensure that the dial is in the “T” (Transport) position or equivalent, depending upon the vaporizer manufacturer’s Instructions For Use.

A5/A3™ Operating Instructions 046-003777-00 2 - 5

Install the Vaporizer Installation

Locking Mechanism

Handle in the

Unlocked Position

Vaporizer dial in the

“T” position

FIGURE 2-2 Vaporizer, Unlocked

3. Rotate the locking mechanism handle clockwise into the locked position as shown in

FIGURE 2-3.

NOTE: If installing a Desflurane vaporizer, refer to the manufacturer’s

Instructions For Use on installation and use of the vaporizer.

Locking Mechanism

Handle in the Locked

FIGURE 2-3 Vaporizer, Locked

4. Final check:

1. Ensure that the top of the vaporizer is horizontal. If not, remove and reinstall the vaporizer.

2. If a vaporizer lifts off the manifold, repeat steps 1 through 3 to reinstall the vaporizer. If the

vaporizer lifts off a second time, do not use the system.

WARNING: For the A5/A3 Anesthesia System, using or turning on more than one

vaporizer simultaneously is prohibited and prevented by a mechanical interlock. Do not attempt to override this safety mechanism.

2 - 6 046-003777-00 A5/A3™ Operating Instructions

Installation Install the Vaporizer

2.3.1 Filling and Draining the Vaporizer

Install the vaporizers with a selectatec interlock system that are compliant to ISO 8835-4 on the

A5 unit. See section A.9 (pg. A-5) "Vaporizers". Refer to the manufacturer’s vaporizer Instructions

For Use for filling or draining the vaporizer and other information.

WARNING: Ensure that the correct anesthetic agent is used. The vaporizer is

designed with the specific anesthetic agent named on it and further indicated by color coded labelling. The concentration of the anesthetic agent actually output will vary if the vaporizer is filled with the wrong agent.

WARNING: Do not reuse the agent drained from the vaporizer. Treat as a hazardous

chemical and follow local regulations for proper disposal.

A5/A3™ Operating Instructions 046-003777-00 2 - 7

Install the Vaporizer Installation

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2 - 8 046-003777-00 A5/A3™ Operating Instructions

3.0

System Interface

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

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

Fresh Gas Flow Display.......................................................................................................................................................................3-10

Waveforms Tab........................................................................................................................................................................................ 3-11

Spirometry Tab (A5 Only)..................................................................................................................................................................3-13

Demographics Tab................................................................................................................................................................................ 3-17

Ventilation Mode Tabs........................................................................................................................................................................3-19

Measured Values Area.........................................................................................................................................................................3-21

Setup ............................................................................................................................................................................................................. 3-29

General Tab................................................................................................................................................................................................3-29

Display Tab.................................................................................................................................................................................................3-31

A5/A3™ Operating Instructions 046-003777-00 3 - 1

Main Screen Components System Interface

3.1 Main Screen Components

The components of the Main screen are shown in FIGURE 3-1.

FIGURE 3-1 A5 Main Screen Components

3 - 2 046-003777-00 A5/A3™ Operating Instructions

System Interface Main Screen Components

FIGURE 3-2 A3 Main Screen Components (without AG gas module connected)

NUMBER

1 Elapsed Timer Displays elapsed time. Select to start, stop, or reset the

2 Fresh Gas Flow Area Displays real-time flowmeter levels for N

3 Patient Size Displays the currently selected patient size (Adult,

4 Current Ventilation Mode Displays the current ventilation mode (VCV, SIMV-VC, PCV,

5 Waveforms Tab See “Waveforms Tab” on page 3-11.

6 Spirometry Tab A5 only. See “Spirometry Tab (A5 Only)” on page 3-13.

7 Demographics Tab See “Demographics Tab” on page 3-17.

* Monitor mode is only available with the AG module. **SIMV-PC and Bypass are only available on A5.

MAIN SCREEN COMPONENT DESCRIPTION

timer.

Pediatric, or Infant). Select to change the patient size when the A5/A3 is in Standby mode, Manual mode or Monitorl* mode

SIMV-PC*, PS, Manual, Bypass**,Monitor or Standby.

O, Air, and O2.

)

A5/A3™ Operating Instructions 046-003777-00 3 - 3

Main Screen Components System Interface

NUMBER

8 Alarm / Prompt Message

COMPONENT DESCRIPTION

Displays physiological alarms, technical alarms, and

Area

prompt messages. The most recent highest priority alarm is displayed at the top.

The remaining alarms are displayed in the lower area and grouped by priority. The most recent of these alarms is displayed first. Select this area to display a list of all active alarms.

See ‘‘Alarms and Messages’’ on page 6-1 for tables that list the individual messages and their associated priority levels. High priority messages are red. Medium priority messages are yellow. Low priority messages are cyan. Prompt messages are black text on white background.

9 Alarm Silence Icon Displays the alarm silence icon and Alarm Silence

countdown timer for 120 seconds when the Silence softkey is selected.

MAIN SCREEN

10 Breathing System Warmer Icon Indicates the warmer is not active.

11 System Date and Time Displays the current system date and time. Select to adjust

the date and time. See ‘‘Date and Time’’ on page 3-8.

12 Main Power Supply and

Battery Status Icon

13 Ventilations Mode and

Setting Parameters Area

Displays the main power supply and battery state. See “Power Management / Battery Supply” on page 1-5.

Displays tabs for all ventilation modes (VCV, SIMV-VC, PCV, SIMV-PC*, PS, Manual/Bypass*or Monitor). Each tab displays the ventilation mode and its parameters. Select a tab and the “Set Mode” softkey to change the ventilation mode. Select a parameter button to change the parameter setting. See ‘‘Ventilation Modes’’ on page 5-7.

* Monitor mode is only available with the AG module. **SIMV-PC and Bypass are only available on A5.

3 - 4 046-003777-00 A5/A3™ Operating Instructions

System Interface Main Screen Components

NUMBER

14 System Softkeys Setup – Select to open the Setup menu. The Setup menu

MAIN SCREEN COMPONENT DESCRIPTION

contains the General tab, Display tab, System tab, and Service tab. Alarms – Select to open the Alarms menu to set alarm limits, set alarm volume, and view all active alarms. Silence – Select Silence softkey to silence all currently sounding alarm tones. The alarm will sound if a new alarm occurs. If the silenced alarms contain middle or high level alarms, the alarm audio will be paused for 120 seconds.The alarm silence icon and 120 second countdown time appear at the top of the screen. Select again to resume the alarm audio. Note, however, the alarm will sound if that a new alarm occurs while the system is in an audio-paused state. If this occurs, you can select the Silence softkey again to silence the new alarm and reset the silence countdown timer to 120 seconds.

Found in software version 03.04.00 and later

If the silenced alarms are only low level alarms, the alarm audio will be turned off till there is a new alarm occurs. Note, however, the alarm will sound if that a new alarm occurs while the system is in an audio-off state. If the new alarm is low level alarm, you can select the Silence softkey again to turn off the new alarm audio. If the new alarm is medium or high level alarm, you can select the Silence softkey again to silence the new alarm for 120 seconds.

Found in software version 03.02.00 and later

History - Select to open the History menu. The History

menu contains the List Trends and Event log. Capture Event - Select to capture an event and log it in the event log.

15 Gas Area Displayed when AG module is connected. Displays real-

time inspiratory and expiratory levels of gas.

* Monitor mode is only available with the AG module. **SIMV-PC and Bypass are only available on A5.

A5/A3™ Operating Instructions 046-003777-00 3 - 5

System Information Header System Interface

3.2 System Information Header

3.2.1 Elapsed Timer

Displays the elapsed time. Located at the top left of the main screen. Select to start, stop, or reset the timer. (FIGURE 3-3)

Elapsed Timer

FIGURE 3-3 Elapsed Timer (with AG module connected)

3.2.2 Patient Size

Displays the currently selected patient size (Adult, Pediatric, or Infant). Select to change the patient size when the A5/A3 is in Standby mode, Manual mode or Monitor mode (available with the AG module). (FIGURE 3-4)

Patient Size

FIGURE 3-4 Patient Size Menu (with AG module connected)

3.2.3 Alarm and Prompt Messages

Displays physiological alarms, technical alarms, and prompt messages. The most recent highest priority alarm is displayed at the top.

The remaining alarms are displayed in the lower area and grouped by priority. The most recent of these alarms are displayed first.

Select this area to display a list of all active alarms. See ‘‘Alarms and Messages’’ on page 6-1 for tables that list the individual messages and their associated priority levels. High priority messages are red. Medium priority messages are yellow. Low priority messages are cyan. Prompt messages are black text on white background. (FIGURE 3-5)

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System Interface System Information Header

FIGURE 3-5 Alarm and Prompt Messages

3.2.4 Alarm Silence Icon

The Alarm Silence icon and Alarm Silence countdown timer are displayed after selecting the Silence softkey is selected, which indicates that all currently sounding alarms are silenced for 120 seconds. (FIGURE 3-6)

Alarm Silence Icon

FIGURE 3-6 Alarm Silence Icon (with AG module connected)

A5/A3™ Operating Instructions 046-003777-00 3 - 7

System Information Header System Interface

3.2.5 Date and Time

Displays the current system date and time. (FIGURE 3-7)

Date and Time

FIGURE 3-7 Date and Time Icon (with AG module connected)

To adjust the date and time:

1. Select the Date and Time icon. The Date/Time dialog is displayed (FIGURE 3-8).

2. Use the dialog keypad and softkeys to adjust the date, time, 12/24 hour format, date format,

and daylight savings time.

NOTE: If applicable, select Daylight Savings Time first before all other

settings.

NOTE: If the Daylight Savings Time On/Off button in the Date/Time

dialog (see Figure 3-8) is disabled and cannot be selected, it is because the Daylight Savings setting has been set to Auto in the System settings (see Table 3-9, “System tab settings,” on page 35).

3. Select the “Accept” to finalize your changes.

FIGURE 3-8 Date and Time Menu

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System Interface System Information Header

3.2.6 Battery Status

Displays the main power supply and battery state (FIGURE ). For more information on the advanced power management system of the A5/A3, see “Power Management / Battery Supply” on page 1-5.

Battery Status Icon

FIGURE 3-9 Battery Status Icon (with AG module connected)

PART(S) DESCRIPTION

Battery supply is partially charged. AC power is connected and charging batteries. The A5/A3 is being powered by AC power.

Battery supply is fully charged. AC power is not connected. The A5/A3 is being powered by internal batteries.

Battery supply is partially charged. AC power is not connected. The A5/A3 is being powered by internal batteries.

Battery supply is low charged. Batteries need to be charged immediately to operate as a safe power backup. AC power is not connected. The A5/A3 is being powered by internal batteries.

Battery supply is not installed.

FIGURE 3-10 Battery Status

A5/A3™ Operating Instructions 046-003777-00 3 - 9

Fresh Gas Flow Display System Interface

3.3 Fresh Gas Flow Display

Displays real-time flowmeter levels for N2O, Air, and O2. (FIGURE 3-11)

The flowmeter numerics display a precision to two decimal digits for flows < 1 L/min and one decimal digit for flows ≥ 1 L/min.

For the A5, the size (height) of the fresh gas flow tubes changes depending on whether the AG module is connected as shown in FIGURE 3-11.

Fresh Gas Flow Display

FIGURE 3-11 Fresh Gas Flow Display

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System Interface Wav eforms Tab

3.4 Waveforms Tab

Displays PAW , Flow, Volume, and CO2 waveforms. (FIGURE 3-12)

Waveforms Tab

FIGURE 3-12 Main Screen Waveforms Tab (with AG module connected)

3.4.1 Waveform Color

WAVEFORM COLO R DESCRIPTIO N

Orange

Cyan

White

Purple

TABLE 3- 1 Waveform color

A5/A3™ Operating Instructions 046-003777-00 3 - 11

Indicates the color of the Paw waveform.

Indicates the color of the Volume and Flow waveform.

Indicates the color of the CO2 waveform.

During the inspiratory phase, Paw and Flow waveforms change to purple when spontaneous breath is detected in ventilation modes that contain pressure support.

Wav eforms Tab System Interface

3.4.2 Waveforms Autoscaling

If the measured value of Paw or Flow is larger than the boundary at the end of breath cycle, the system will auto scale the Paw or Flow at the beginning of the next breath cycle.

If the measured value of Paw or Flow is less than the boundary minus a margin at the end of two continuous breath cycles, the A5/A3 System will auto scale the Paw or Flow at the beginning of next breath cycle.

Paw scale:

The margin will be 10 cmH pressure

≥ 30 cmH2O.

O. For software version 03.02.00 and later, the margin will be 10 cmH2O if

For software version 03.02.00 and later, the margin will be 3 cmH2O if pressure

Flow scale:

• The margin will be 10 L/min if Flow ≤ 30 L/min

• The margin will be 15 L/min if Flow > 30 L/min

Volume scale:

• The margin will be 25mL if volume ≤

100 mL

• The margin will be 100 mL if volume > 100 mL

scale:

The CO2 scale options are shown in the table below:

CO2 UNIT OF MEASURE SCALE

mmHg

kpa

TABLE 3- 2 CO

Scale

0-40 0-60 0-80

0.0-5.0 0.0-8.0 0.0-10.0

<30 cmH2O.

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System Interface Spirometry Tab (A5 Only)

3.5 Spirometry Tab (A5 Only)

Displays separate looped graphs of Pressure-Volume (FIGURE 3-13) and Flow-Volume (FIGURE 3-14).

Spirometry Tab

FIGURE 3-13 Spirometry: Pressure-Volume Loop (with AG module connected)

FIGURE 3-14 Spirometry: Flow-Volume Loop (with AG module connected)

A5/A3™ Operating Instructions 046-003777-00 3 - 13

Spirometry Tab (A5 Only) System Interface

Spirometry loops reflect patient lung function and ventilation. They also indicate other related parameters such as compliance, over-inflation, breathing system leak, and airway blockage.

The system provides two spirometry loops: P-V (Paw-volume) loop and F-V (flow-volume) loop. Data of P-V and F-V loops come from pressure and flow data. Only one loop is displayed at a time.

The spirometry tab displays four softkeys: Loop Type, Show Reference, Save Loop, and Review Loops.

3.5.1 Loop Type

The Loop Type selection is used to select Pressure - Volume loop or Flow - Volume loop to display on the spirometry screen. Default Loop Type is Pressure - Volume loop.

Show Reference

Loop Type

FIGURE 3-15 Spirometry Softkeys: Loop Type, Show Reference, Save Loop, and Review Loops

3.5.2 Show Reference

The Show Reference softkey can be selected only after a baseline has been saved via the Save Loop softkey.

The Show Reference softkey (FIGURE 3-15) is used to select and display a saved Baseline loop, Reference loop, or no loop (Off ) in the Spirometry Loop Window, overlapped with the currently plotting loop. Only the four most recently saved reference loops are listed chronologically.

Review Loops

Save Loop

When a Reference loop or Baseline loop is selected to display in the Spirometry Loop Window, the time stamp will also be displayed.

3.5.3 Save Loop

Select the Save Loop softkey (FIGURE 3-15) to save the currently plotting loop (including its numeric data) as either a baseline loop or reference loop. Only one baseline loop and up to four reference loops can be saved. Additional plotting loops can be saved to replace the baseline loop or reference loops. Only the four most recent reference loops are saved.

The saved baseline or reference loop can be reviewed with its numeric data (via Review Loops softkey) or displayed with the currently plotting loop on the same graph for comparison (via Show Reference softkey).

NOTE: A reference loop cannot be saved without first saving a

baseline loop. The A5 system will always make the first saved loop as the baseline loop if no previous loops have been saved. Afterward, additional loops can be saved either as a baseline replacement or as a new reference loop.

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System Interface Spirometry Tab (A5 Only)

To save a baseline loop:

1. From the main screen, select Spirometry tab > Save Loop softkey.

If there is no baseline loop saved in memory, the currently plotting loop will be saved automatically as the baseline loop.

2. If a baseline loop is already saved in memory, a dialog box will appear with the choices of

“Baseline“ and ”Reference“. S el ect ” Baseline”. A confirmation dialog will be displayed with the text “Selecting Yes will replace the currently saved Baseline loop. Do you want to proceed?” If “Ye s ” is selected, the currently saved baseline loop will be replaced. If “No” is chosen, the save will be aborted.

To save a reference loop:

1. From the main screen, select Spirometry tab > Save Loop softkey. If a baseline loop is

already saved in memory, a dialog box will appear with the choices of "Baseline" and "Reference". Select "Reference".

A maximum of four (4) sets of Reference loops plus one (1) Baseline loop and corresponding numeric data can be saved.

When the maximum of four (4) loops is reached, and the user attempts another save, a confirmation dialog will be displayed with the following text, “Selecting Yes will replace the oldest reference loop. Do you want to proceed?” If “Ye s” is chosen, the oldest data will be removed as the new data is added. If "No" is chosen, the save will be aborted.

3.5.4 Review Loops Button

Selecting the Review Loops softkey (FIGURE 3-15) displays the Review Loops screen (FIGURE 3-16). The following areas and selections are displayed:

Small Loop Windows: These small graphic windows show the baseline and reference loops. The baseline loop (only one) is always located on the left and has a white border around its graph. The reference loops (up to four) are located to the right of the baseline loop. The reference loops are displayed from oldest (left) to newest (right).

The baseline loop information is displayed below the small baseline loop window. The reference loop information is displayed in cyan highlight for the reference loop that is selected.

Large Loop Window: This graphic window shows an enlarged view of the selected reference loop overlapped with the baseline loop.

Loop Type: The Loop Type selection is used to choose the type of loop to review. The choices are: Pressure-Volume and Flow Volume. Default Loop Type is Pressure - Volume loop.

Delete Loop: The Delete Loop selection is used to delete a selected Reference loop. When a reference loop is deleted, the newer reference loops will shift to the left. The Delete Loop button will be disabled (grayed out) if no reference loops have been saved. The baseline loop cannot be deleted. It can only be replaced by another baseline loop.

A5/A3™ Operating Instructions 046-003777-00 3 - 15

Spirometry Tab (A5 Only) System Interface

Non-selected

Baseline Loop

Numeric Data

Area

Non-selected

Reference Loop

Selected Reference

Loop (small)

Non-selected Reference

Loop

Selected

Reference

Loop (large)

FIGURE 3-16 Review Loops window

Numeric Data Area: Displays the numerical data associated with a saved Baseline loop and saved Reference loops. The parameters listed in column form include: Time, Expiratory Minute Volume

(Mv Exp), Inspiratory Minute Volume (Mv Insp), Expiratory Tidal Volume (Vt Exp), Inspiratory Tidal Volume (Vt Insp), Ratio of Inspiratory time to Expiratory time (I:E), Positive End Expiratory Pressure (PEEP), Rate, Peak Inspiratory Pressure (PEAK), Plateau Pressure (PLAT), Mean Pressure (MEAN), Dynamic Airway Compliance (Compl), and Airway Resistance (Raw).

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System Interface Demographics Tab

3.6 Demographics Tab

The Demographics tab is located on the main screen next to the Waveforms tab on the A3 system, and next to the Spirometry tab on the A5 system (FIGURE 3-17). The Demographics tab contains editable fields to enter patient and hospital data (TABLE 3-3).

NOTE: Facility data should be entered when first setting up the

machine. After entering facility data, the user should go to the System tab>Manage Defaults>Save as O.R. Defaults so that the data is not erased on power cycle or discharge.

EDITABLE FIELD COMMENT

Patient ID Enter up to 30 characters per field. These fields are cleared when the patient is

First Name

Last Name

DOB (Date Of Birth) Enter the information from the virtual keypad. If the calculated age of the

Weight (lbs/kg)

Bed Enter up to 20 characters per field. When the Restore default settings checkbox

Room

Point of Care

Faci lity

TABLE 3- 3 Demographic Tab Fields for Patient and Hospital Data

discharged or if the A5/A3 is power cycled.

patient is outside the accepted range (0-150), a prompt message is displayed. These fields are cleared when the patient is discharged or if the A5/A3 is power cycled.

is selected, these fields are NOT cleared when the patient is discharged (applies to software version 03.02.00 and later).

A5/A3™ Operating Instructions 046-003777-00 3 - 17

Demographics Tab System Interface

Demographics Tab

FIGURE 3-17 Demographics Tab

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System Interface Ventilation Mode Tabs

3.7 Ventilation Mode Tabs

Displays tabs for all ventilation modes. Each tab displays the ventilation mode and its parameters. (FIGURE 3-18 to FIGURE 3-25)

A5 ventilation modes: VCV, SIMV-VC, PCV, SIMV-PC, PS, Manual, Bypass, and Monitor (with AG module) A3 ventilation modes: VCV, SIMV-VC, PCV, PS, and Manual (only A5 can have the AG module)

Ventilation Mode Tabs

FIGURE 3-18 Ventilation Mode Tabs (with AG module installed)

To change the ventilation mode:

1. Select a desired ventilation mode tab. The Set Mode softkey begins to blink green.

2. Optionally, select one or more parameter buttons to change the parameter settings of the

desired ventilation mode. Select the “Accept” button to save each parameter change.

3. Select the “Set Mode” softkey to finalize and change the ventilation mode.

NOTE: If the Set Mode softkey is not selected after several seconds, an

audible reminder is sounded, and then the desired ventilation mode is cancelled.

FIGURE 3-19 Ventilation Mode: VCV

FIGURE 3-20 Ventilation Mode: SIMV-VC

A5/A3™ Operating Instructions 046-003777-00 3 - 19

Ventilation Mode Tabs System Interface

FIGURE 3-21 Ventilation Mode: PCV (A5 unit)

FIGURE 3-22 Ventilation Mode: PCV (A3 unit)

FIGURE 3-23 Ventilation Mode: SIMV-PC (A5 only)

FIGURE 3-24 Ventilation Mode: PS

FIGURE 3-25 Ventilation Mode: Manual

NOTE: Bypass function is available only on the A5.

FIGURE 3-26 Ventilation Mode: Manual (with AG module installed)

NOTE: Bypass function is available only on the A5.

NOTE: Monitor mode available when external AG module connected.

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System Interface Measured Values Area

3.8 Measured Values Area

The Measured Values area is used to display the numerical data. The parameters include: End tidal CO2(with AG module connected), Fractional CO2 (with AG module connected), Peak Inspiratory Pressure (PEAK), Plateau Pressure (PLAT) (user can configure this to display Mean Pressure (MEAN) or PLAT (see “Pressure Display” on page 3-32)), Positive End Expiratory Pressure (PEEP), I:E Ratio, Expiratory Tidal Volume (Vt), Expiratory Minute Volume (MV),and Breath Rate (Rate), and Inspiratory

% (FiO2). (FIGURE 3-27)

Measured Values Area

FIGURE 3-27 Measured Values Area (no AG module connected)

FIGURE 3-28 Measured Values Area (without AG module connected)

A5/A3™ Operating Instructions 046-003777-00 3 - 21

System Softkeys System Interface

3.9 System Softkeys

The A5/A3 System provides system softkeys at the bottom right of the main screen for direct access to the history menu, system setup, and alarms menu, and for capturing events and silencing alarms. (See Figure 3-29)

FIGURE 3-29 System Softkeys

3.9.1 Setup Softkey

Select the Setup softkey on the main screen to display the Setup menu. See Figure 3-29, “System Softkeys,” on page 22.

The Setup menu contains the General tab, Display tab, System tab, and Service tab. See section 3.12 (pg. 3-31) "Display Tab".

3.9.2 Alarms Softkey

Select the Alarms softkey on the main screen to open the Alarms menu to set alarm limits, set alarm volume, and view all active alarms. See “Alarms and Messages” on page 6-1.

3.9.3 Silence Softkey

Select Silence softkey to silence all currently sounding alarm tones. The alarm will sound if a new alarm occurs.

If the silenced alarms contain middle or high level alarms, the alarm audio will be paused for 120 seconds.The alarm silence icon and 120 second countdown time appear at the top of the screen. Select again to resume the alarm audio. Note, however, the alarm will sound if that a new alarm occurs while the system is in an audio-paused state. If this occurs, you can select the Silence softkey again to silence the new alarm and reset the silence countdown timer to 120 seconds.

Found in software version 03.04.00 and later

3.9.4 Capture Event (Software Version 03.02.00 and later)

Select the Capture Event softkey to capture parameters and log it in the Event Log(FIGURE 3-32). Capture Event softkey is disabled when the machine is in standby.

3.9.5 History (Software Version 03.02.00 and later)

The History button provides access to a patient’s historical physiological parameters. The History dialog contains List Trends, Graphic Trends and an Event Log tab.

3.9.5.1 List Trends

List Trends can be accessed by selecting the History button from the main screen. The History dialog displays (as shown in FIGURE 3-30) with the List Trends tab selected.

The List Trends display allows the user to view a tabular list of the physiological parameters. Trend data automatically displays in one minute intervals unless an alternate interval is selected.

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System Interface System Softkeys

FIGURE 3-30 List Trends

3.9.5.1.1 About List Trends

• List Trends displays the time and date on the horizontal axis and it is always visible.

• List Trends displays the parameter name on the vertical axis and it is always visible.

• List Trends displays the trend records in descending order beginning with the most recent on

the right side of the grid.

• ListTrends are not stored when the machine is in standby.

• The display period of data is a rolling 48 hours of continuous data.

• List Trends highlights the parameter data in the corresponding alarm color if an alarm

condition existed for the parameter at the time of trend record storage.

3.9.5.1.2 Navigating in List Trends

The dialog navigation buttons are described in TABLE .

NOTE: When a navigation button becomes disabled, this indicates that

there is no more data available or the end of the data range was reached.

BUTTON FUNCTION

Moves the cursor to the oldest record from its current position.

Moves the cursor one page back from its current position.

A5/A3™ Operating Instructions 046-003777-00 3 - 23

System Softkeys System Interface

BUTTON FUNCTION

Moves the cursor one record back from its current position.

Moves the cursor one record forward from its current position.

Moves the cursor one page forward from its current position.

Moves the cursor to the newest record from its current position.

Previous Event Moves the cursor to the previous event from its current position.

Next Event Moves the cursor to the next event from its current position.

Moves the cursor up one parameter from its current position.

Moves the cursor down one parameter from its current position.

TABLE 3- 4

3.9.5.1.3 Display Interval

Display Interval allows for the trends to be displayed in a specified time interval between two neighboring columns.

Set Display Interval to 1Min, 5Min, 10Min, 15Min, 30Min, 1Hour, or 2Hour.

3.9.5.1.4 Display Groups

Display Group allows for the trends to be displayed in a specified parameter group.

Set Display Group to Gas, Fresh Gas, Vent ilation, or All.

3.9.5.1.5 List Trend Export

The Export button on the List Trend tab is always disabled. This button will be available in a future software release.

3.9.5.2 Graphic Trends (Software Version 03.04.00 and later)

The Graphic Trends can be accessed by selecting the History button from the main screen and then selecting the Graphic Trends tab. The History dialog displays (as shown in FIGURE 3-31 below) with the Graphic Trends tab selected.

Graphic trends display allows the user to observe the trend of the physiological parameters. The trend is reflected through a curve. Every point on the curve corresponds to the parameter value at a specific time point. Graphic Trends tab displays Discharge event, Captured event and parameter alarm event. Graphic trend data automatically displays in one minute intervals unless the zoom is selected.

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System Interface System Softkeys

FIGURE 3-31 Graphic Trends

NUMBER DESCRIPTION

1 Event marker. The Dotted,colored line indicate an event occurred at that time.

Events could be the followings: discharge a patient , capture an event or a physiological alarm occurs. When discharge a patient or capture an event , the dotted line is white. When a physiological alarm occurs, the dotted line is in the sam e color with al arm. I f multiple event s occur ed, dot ted lin e is in same co lor with the event of the highest alarm level. The event level can be specified as:High alarm level event>Medium alarm level event>Low alarm level event>Capture event>Discharge patient event.A discharge event occured during this period.

2 Current cursor. The corresponding time displays above the cursor. If alarms

occured at that time, the corresponding alarm information will also display above the cursor.

3 A discharge event occured during this period.

4 The parameter data of the time indicated by cursor.

TABLE 3- 5

NOTE: Graphic Trends will be cleared after the anesthesia machine

undergoes power failure or is turned off.

A5/A3™ Operating Instructions 046-003777-00 3 - 25

System Softkeys System Interface

3.9.5.2.1 About Graphic Trends

• Graphic Trends store the data with the interval in 1 minute.

• Graphic Trends displays the trend records in descending order beginning with the most

recent on the right side of the grid.

• Graphic Trends are not stored when the machine is in standby.

• The display period of data is a rolling 48 hours of continuous data.

• Graphic Trends highlights the parameter data in the corresponding alarm color if an alarm

condition existed for the parameter at the time of trend record storage.

3.9.5.2.2 Navigating in Graphic Trends

The dialog navigation buttons are described in TABLE 3-6.

NOTE: When a navigation button becomes disabled, this indicates that

there is no more data available or the end of the data range was reached.

BUTTON FUNCTION

Moves the cursor to the oldest record from its current position.

Moves the cursor one page back from its current position.

Moves the cursor one record back from its current position.

Moves the cursor one record forward from its current position.

Moves the cursor one page forward from its current position.

Moves the cursor to the newest record from its current position.

Previous Event Moves the cursor to the previous event from its current position.

Next Event Moves the cursor to the next event from its current position.

Moves the cursor up one parameter from its current position.

Moves the cursor down one parameter from its current position.

TABLE 3- 6

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System Interface System Softkeys

3.9.5.2.3 Zoom

Zoom allows the trends to be displayed in one page in a specified time interval.

Set Zoom to 5Min, 10Min, 15Min, 30Min, 1Hour, or 2Hour.

3.9.5.2.4 Display Groups

Display Group allows for the trends to be displayed in a specified parameter group.

Set Display Group to Gas, Fresh Gas, Vent ilation, or All.

3.9.5.2.5 Graphic Trends Export

The Export button on the Graphic Trends tab is always disabled. This button will be available in a future software release.

3.9.5.3 Event Log

The Event Log can be accessed by selecting the History button from the main screen and then selecting the Event Log tab. The History dialog displays (as shown in FIGURE 3-32 below) with the Event Log tab selected.

FIGURE 3-32 Event Log

The Event Log tab logs such events as technical alarms, physiological alarms, capture events, delay power off, discharge, delay power off canceled and system time change. Events can be physiological indicating that a patients physiological alarm thresholds have been violated or technical indicating that a specific technical issue has occurred.

An alarm entry and captured events in the Event Log displays the time, date, event, priority and additional information which includes the Ventilation Mode, Patient Size, and Monitored Parameters.

A5/A3™ Operating Instructions 046-003777-00 3 - 27

System Softkeys System Interface

NOTE: Event log will be cleared after the anesthesia machine

undergoes power failure or is turned off.

3.9.5.3.1 Navigating in the Event Log

The dialog navigation buttons are described in TABLE 3-5.

NOTE: When a navigation button becomes disabled, this indicates that

there is no more data available or the end of the data range was reached.

BUTTON FUNCTION

Moves the scroll up one record.

Moves the scroll up one page.

Moves the scroll to the top most parameter.

TABLE 3- 7

3.9.5.3.2 Event Log Filter

The Filter button allows for the Event Log Entries trends to be displayed in a similar Event type.

Set Filter to High, Medium, Low, Informational or All. A7 will display the corresponding event based on your setting.

3.9.5.3.3 Event Log Export

The Export button on the Event Log tab will allow the contents of the Event Log to be exported to a USB mass storage device. The format of the data exported is a .html file which can be opened using Internet Explorer version 6.0 or later. The Export button on the Event Log Tab is only available when the system is in standby mode.

Moves the scroll down one record.

Moves the scroll down one page.

Moves the scroll to the bottom most parameter.

3 - 28 046-003777-00 A5/A3™ Operating Instructions

System Interface Setup

3.10 Setup

Select the Setup softkey (FIGURE 3-29) to open the Setup menu (FIGURE 3-33).

The Setup menu contains the General tab, Display tab, System tab, and Service tab. See section 3.12 (pg. 3-31) "Display Tab".

NOTE: The System tab is only available in Standby mode.

NOTE: The Service tab is for use only by Mindray Technical Service.

Please contact Mindray Technical Support for details.

Many of these functions are only available if the A5/A3 is in Standby mode.

3.11 General Tab

The General tab provides access to calibrate the O2 sensor and flow sensor, perform system leak and compliance tests, activate the breathing system warmer, and zero flow meters. The General tab also displays information for the most recent calibrations and leak test results, whether they were passed, failed, or skipped. (See Figure 3-33)

FIGURE 3-33 General Tab (with AG module connected)

Calibrate O2 Sensor

To calibrate the O2 sensor, select the Calibrate O2 Sensor button. Follow the on-screen directions and prompts. See ‘‘O2 Sensor Calibration’’ on page 7-6 for more information. Note that information for the last O

sensor calibration is displayed next to the button.

Calibrate Flow Sensor

To calibrate the flow sensor, select the Calibrate Flow Sensor button. Follow the on-screen directions and prompts. See ‘‘Flow Sensor Calibration’’ on page 7-5 for more information. Note that information for the last flow sensor calibration is displayed next to the button.

A5/A3™ Operating Instructions 046-003777-00 3 - 29

General Tab System Interface

Leak Test / Compliance

The Test Leak / Compliance button enables the A5/A3 system to perform a manual leak test and automatic leak test, and calculates the compliance for the A5/A3.

To perform a leak test, select the Tes t Lea k/Com plia nce button. Follow the on-screen directions and prompts. See ‘‘Leak and Compliance Tests’’ on page 4-9 for more information. Note that information for the last Leak Test / Compliance is displayed next to the button.

Breathing System Warmer

Select to set the breathing system Warmer On (default) or Warmer Off. If the Breathing System is selected Warmer Off or if AC power is not connected, the system displays an icon to indicate that the warmer is not active.

After cycling power, the breathing system warmer will return to the default state.

NOTE: The breathing system warmer is inactive when the A5/A3 is

Zero Flow Meters

To zero the flow meters, select the Zero Flow Meters button. Follow the on-screen directions and prompts. Note that information for the last zeroing of the flow meters is displayed next to the button.

NOTE: Before zeroing the flow meters, make sure to disconnect the

gas supply (N

O, Air, O2).

Gas Bench Flow Rate

To set the gas bench flow rate, select the Gas Bench Flow Rate button. The flow rate can be set to High, Medium, or Low (default).

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System Interface Display Tab

3.12 Display Tab

Screen Brightness

To adjust the screen brightness:

1. Select Setup softkey > Display tab (FIGURE 3-34).

2. In the Screen Brightness area, select +/- buttons to adjust the screen brightness.

3. Select the Accept button to confirm the change, or select Cancel button to disregard the

change.

Select the +/- buttons to

adjust screen brightness.

FIGURE 3-34 A5/A3 Display Tab: Screen Brightness Area

A5/A3™ Operating Instructions 046-003777-00 3 - 31

Display Tab System Interface

Key Click Volume

To adjust the key click volume:

1. Select Setup softkey > Display tab.

2. In the Key Click Volume area, select the +/- buttons to adjust the key click volume.

3. Select the Accept button to confirm the change, or select Cancel button to disregard the

change.

Select the +/- buttons to

adjust the key click volume.

FIGURE 3-35 A5/A3 Display Tab > Key Click Volume Area

Clean Screen

To clean the LCD touch screen:

1. Select Setup softkey > Display tab.

2. Select the Clean Screen button.

The screen will lock for 10 seconds for cleaning.

Calibrate Touch

To calibrate the LCD touch screen:

1. Select Setup softkey > Display tab.

2. Select the Calibrate Touch button.

3. Follow the on-screen directions.

Pressure Display

To change the pressure display:

1. Select Setup softkey > Display tab.

2. Select the Pressure Display button.

3. Choose between MEAN and PLAT.

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System Interface Display Tab

4. Select the Accept button to confirm the change, or select Cancel button to disregard the

change.

Plimit Line

The Plimit line function displays a dashed line in the Pressure waveform area to indicate the Plimit position. The Plimit line can be displayed in VCV, SIMV-VC, and PCV with VG on mode. The Plimit line function can be switched On or Off by the user. The default value for Plimit Line is On.

Plimit Line

FIGURE 3-36 Plimit Line

NOTE: The Plimit line does not affect the auto-scaling algorithm. If the

Plimit line is turned on but not visible, it may be because the line is positioned off the waveform scale.

To set the Plimit Line to ON or OFF

1. Select Setup softkey > Display tab.

2. Select the Plimit Line button to ON or OFF.

3. Select the Accept button to confirm the change, or select Cancel button to disregard the

change.

CO2 Placement (with an AG module connected)

The CO2 waveform/data can be positioned at the top or bottom of the Waveform area.

To s et th e CO

1. Select Setup softkey > Display tab.

2. Select the CO

3. Select To p or Bottom.

4. Select the Accept button to confirm the change, or select Cancel button to disregard the

change.

placement:

Placement button.

CO2 Scale (with an AG module connected)

The CO2 scale of the CO2 waveform can be adjusted to one of three settings. The table below shows

scale options.

the CO

To s et th e CO2 scale:

1. Select Setup softkey > Display tab.

2. Select the CO

Scale button.

A5/A3™ Operating Instructions 046-003777-00 3 - 33

System Tab System Interface

3. Select the desired scale setting according to the table below:

CO2 UNIT OF MEASURE SCALE

mmHg

kpa

TABLE 3- 8 CO

4. Select the Accept button to confirm the change, or select Cancel button to disregard the

change.

Scale

0-40 0-60 0-80

0.0-5.0 0.0-8.0 0.0-10.0

Waveform Display (Software version 03.02.00 and later)

1. Select Setup softkey > Display tab.

2. Select the Waveform Display button.

3. Select Vol ume or Flow.

4. Select the Accept button to confirm the change, or select Cancel button to disregard the

change.

3.13 System Tab

The System tab is accessible only by authorized administrative service personnel with password access. The system tab can only be accessed in Standby mode.

NOTE: The default System tab password is: 1234. The authorized

administrator should change the default password immediately after the system is installed to prevent unauthorized access to the System tab. The password can be maximum of 6 digits in length containing numerals 0 to 9.

FIGURE 3-37 A5/A3 Setup menu > System tab

3 - 34 046-003777-00 A5/A3™ Operating Instructions

System Interface System Tab

SYSTEM TAB BUTTON CHOICES DESCRIPTION

Calibration External AG Module

O2 Sensor

Language ENGLISH(default)

CHINESE FRENCH SPANISH PORTUGUESE RUSSIAN TURKISH DUTCH

Default Patient Size Adult

Pediatric Infant (default)

Manage Defaults Save Defaults

Save as O.R. Defaults

Select to calibrate the External AG Module or O2 sensor. Follow the screen directions. The date and time of the last calibration is displayed next to the

O2 Sensor or External AG Module button.

NOTE: The AG module information appears only

when an AG module is connected to the A5 system.

Select to set the language of the user interface text.

Select to set the default patient size.

Select “Save Defaults” or “Save as O.R. Defaults” to save the current configuration as the user default configuration.

Load User Defaults Load O.R. Defaults

Restore Partial Defaults

Import Defaults

Export Defaults

TABLE 3- 9 System tab settings

Select “Load User Defaults” or “Load O.R. Defaults” to load the user default configuration.

Select “Restore Partial Defaults” to overwrite the user defaults and system settings with the factory default settings. Note that network settings will not be restored.

Select “Import Defaults” to import a copy of the defaults from the USB mass storage device if one has been inserted into an SB port at the rear of the A5/A3 unit.

Select “Export Defaults” to export a copy of the defaults to the USB mass storage device if one has been inserted into an SB port at the rear of the A5/ A3 unit.

A5/A3™ Operating Instructions 046-003777-00 3 - 35

System Tab System Interface

SYSTEM TAB BUTTON CHOICES DESCRIPTION

Time Settings Time Zone (Default =

UTC-05:00)

Select to set the UTC time zone offset.

Daylight Savings (Default =Manual, Auto)

DST Start (Default =First Sunday in April at 2:00 AM)

DST End (Default =Last Sunday in October at 3:00 AM)

Network See section 3.13.1 (pg. 3-37) "Network Configuration".

Set HL7 Compatibility (Software Version

03.04.00 and later)

Change Password 1234 (default) Select to change the System tab password. The

Set Pressure Unit cmH2O(default)

Set CO2 Unit mmHg(default)

Most Recent(Default)

02.00.00

01.05.02

01.00.00 to 01.05.01 None

hPa mbar

kPa %

Select to set the Daylight Savings Time (DST) to be adjusted automatically by the A5 system, or manually by the authorized administrator. If the region or country of installation does not observe DST, change this setting to Manual. If Daylight Savings is set to Auto, the Daylight Savings Time On/Off button in the Date/Menu dialog becomes inactive and cannot be selected (see FIGURE 3-8)

Select to set the START of Daylight Savings Time. This setting is not available if DST is set to Manual.

Select to set the END of Daylight Savings Time. This setting is not available if DST is set to Manual.

Select the compatible HL7 version according to the HL7 version of clinical information system. If clinical information system is not connected, keep the setting as default.

authorized administrator should change the default password immediately after the system is installed to prevent unauthorized access to the System tab. The password can be up to 6 digits in length containing numerals 0 to 9.

Select to set the

Select to set the CO2 unit.

NOTE: Set CO2 Unit button only

Pressure Unit of measure.

displays if an external AG module is connected to the A5.

TABLE 3- 9 System tab settings

3 - 36 046-003777-00 A5/A3™ Operating Instructions

System Interface System Tab

SYSTEM TAB BUTTON CHOICES DESCRIPTION

Configuration Information

Export Data — Select to export patient data via mass storage

Discharge Settings On(default)

— Select to display the machine ID and the status of

system functions.

device.

Configures the Clear History setting during a

Off

discharge. When turned on, Event Logs and List Trends will be deleted upon discharge. When turned off, Event Logs and List Trends will not be deleted upon discharge.

TABLE 3- 9 System tab settings

3.13.1 Network Configuration

Network configuration settings can be set via the Network button (see Figure 3-38): Select Main screen > Setup button > System tab > Network button.

NOTE: Button only appears for

software version 03.02.00 and later.

A5/A3™ Operating Instructions 046-003777-00 3 - 37

System Tab System Interface

FIGURE 3-38 Network Configuration Screen

Table 3-10 on page 38 lists the network settings and parameters.

NOTE: MAC and EUI (Extended Unique Identifier) values are displayed

on software version 03.02.00 and later.

SETTINGS PARAMETERS

This Machine

Configure Ethernet Enter:

• IP Address (default = 192.168.23.250)

• Subnet (default = 255.255.255.0)

• Default Gateway (default = [blank])

TABLE 3- 10 Network Configuration Settings and Parameters

3 - 38 046-003777-00 A5/A3™ Operating Instructions

System Interface System Tab

SETTINGS PARAMETERS

Configure Serial Select:

• Protocol (None (default), MR-Link/HL7, MR-WATO)

• Baud Rate (57600, 11520(default))

• Data Bits (8 (default), 7, 6, 5)

• Stop Bits (1 (default), 2)

• Parity (Odd, Even, None (default))

• Interval: Enabled when Protocol=None: Off(default);

Enabled when Protocol=HL7:10 Sec, 30 Sec, 1 Min(default), 5 Min, 30 Min, 1 Hour, 2 Hour, 6 Hour, 12 Hour, 24 Hour.

NOTE: MR-Link renamed to HL7 on

software version 03.02.00 and later.

Network Protocol

HL7 Select:

Interval (enabled when HL7 = On) Select:

Destination IP (enabled when HL7 = On) Enter:

Port (enabled when HL7 = On) Enter:

SNTP Protocol

Interval Select:

Primary Ser ver IP Enter:

Secondary Server IP Enter:

On, Off (default)

10 sec, 30 sec, 1 min (default), 5 min, 30 min, 1 hour, 2 hour, 6 hour, 12 hour, 24 hour

Destination IP (default = 192.168.23.200)

Port (default = 1550)

Off (default), 10 sec, 30 sec, 1 min, 5 min, 30 min, 1 hour, 2 hour, 6 hour, 12 hour, 24 hour

Primary Server IP (default = 132.163.4.103)

Secondary Server IP (default = 210.72.145.44)

TABLE 3- 10 Network Configuration Settings and Parameters

A5/A3™ Operating Instructions 046-003777-00 3 - 39

Service Tab System Interface

3.14 Service Tab

Accessible only by Mindray-authorized service personnel. Please contact Mindray Technical Support for assistance.

3 - 40 046-003777-00 A5/A3™ Operating Instructions

4.0

Preoperative Tests

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

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

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

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

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

Power Failure Alarm Test................................................................................................................................................................... 4-17

Basic Ventilation Testing.................................................................................................................................................................... 4-18

Flow Control System Test.................................................................................................................................................................. 4-20

Vaporizer Tests.........................................................................................................................................................................................4-21

Breathing System Tests ...................................................................................................................................................................... 4-23

Alarm Tests.................................................................................................................................................................................................4-25

Preoperative Preparations................................................................................................................................................................ 4-27

Inspect the AGSS.................................................................................................................................................................................... 4-28

A5/A3™ Operating Instructions 046-003777-00 4 - 1

Preoperative Test Schedules Preoperative Tests

4.1 Preoperative Test Schedules

Preoperative tests on the A5/A3 should be performed according to the test intervals listed below. Refer to special procedures or precautions in this manual.

NOTE: This is a guideline which can be modified to accommodate variations in

local clinical practice. Such local modifications should have appropriate peer review.

NOTE: It is recommended that the user check that N

are normal before use. Use an O concentration in the gas output.

4.1.1 Test Intervals

Perform the preoperative tests listed below at these events:

• When required after a maintenance or service procedure

• Every day before the first patient:

• System Self-Test (Section 4.4)

• Leak and Compliance Tests (Section 4.5)

• Pipeline Tests (Section 4.7)

• Basic Ventilation Testing(Section 4.8)

• Cylinder Tests (Section 4.9)

• Flow Control System Test (Section 4.10)

• Vaporizer Tests (Section 4.11)

• Before each patient:

• Inspect the System (Section 4.2)

• Pre-Operative Checkout List (Section 4.3)

• Perform the Leak/Compliance Test (Section 4.5)

• Power Failure Alarm Test (Section 4.6)

• Breathing System Tests (Section 4.12)

• Alarm Tests (Section 4.13)

• Preoperative Preparations(Section 4.14)

• Inspect the AGSS (Section 4.15)

O cutoff and O2/N2O ratio

concentration tester to monitor the O2

NOTE: Read and understand the operation and maintenance of each

component before using the A5/A3 anesthesia machine.

NOTE: Do not use the A5/A3 anesthesia machine if a test failure occurs.

Contact Mindray Technical Support for assistance.

NOTE: A checklist of the anesthetic system should be provided, including

anesthetic gas delivery system, monitoring device, alarm system, and protective device, which are intended to be used for the anesthetic system, whether they are used alone or assembled together.

4 - 2 046-003777-00 A5/A3™ Operating Instructions

Preoperative Tests Inspect the System

4.2 Inspect the System

NOTE: Ensure that the breathing system is correctly connected and not

damaged.

Perform the following inspection checklist before operating the A5/A3 unit:

1. The A5/A3 anesthesia machine is correctly connected and undamaged.

2. Inspect the system for:

a. Damage to flowmeters, vaporizers, gauges, supply hoses

b. Complete breathing system with adequate CO

c. Correct mounting of cylinders in yokes

d. Presence of cylinder wrench

e. Auxiliary O

supply, available and functioning

3. Check that:

a. Gas cylinders are turned off until needed to prevent the unintended use of gases

b. Flow-control valves are off

c. Vaporizers are off

d. Vaporizers are filled (not overfilled)

e. Filler caps are sealed tightly

f. Two vaporizers cannot be turned on at the same time

4. All components are correctly attached.

5. The breathing system is correctly connected, the breathing tubes are undamaged, and the

self-inflating manual ventilation device is available and functioning.

6. The gas supplies are connected and the pressures are correct.

7. Cylinder valves are closed on models with cylinder supplies (Verify that the cylinder wrench

is attached.).

8. The necessary emergency equipment is available and in good condition.

9. Equipment for airway maintenance and tracheal intubation is available and in good

condition.

10. Inspect the color of the sodalime in the canister. Replace the sodalime immediately if

obvious color change is detected. The sodalime is white when new. If it is purple, it must be changed.

absorbent Pre-Pak or loose fill

WARNING: Check if the gasket is properly installed in place while installing the

absorber canister. If the gasket is not properly installed (for example, gasket is not evenly seated and centered) it may cause breathing system leakage.

11. Applicable anesthetic and emergency drugs are available.

12. The casters are not damaged or loose, and the brake(s) is set and prevents movement.

13. Ensure the breathing system is in proper position.

14. The AC mains indicator and the battery indicator are displayed when the power cord is

connected to the AC power source. If the indicators are not displayed, the system does not have electrical power.

15. The A5/A3 anesthesia machine is switched on or off normally.

A5/A3™ Operating Instructions 046-003777-00 4 - 3

Pre-Operative Checkout List Preoperative Tests

4.3 Pre-Operative Checkout List

4.3.1 Introduction

The purpose of the pre-operative checkout is to detect potential system problems before use.

An effective method for detecting pneumatic circuit occlusions, leaks, and other system problems can be found in the A5/A3 pre-operative checkout procedures. In addition, it is recommended that the breathing circuit be tested for the ability to effectively deliver positive pressure ventilation before beginning each case. Testing the ability to properly ventilate a test lung can quickly identify an occluded circuit limb and other breathing circuit problems.

Before starting each case, test the machine’s ability to ventilate the patient by removing the breathing bag from the bag arm and connecting it to the patient connection (elbow or Y-piece on the disposable circuit). Set the ventilator to deliver a specific tidal volume to the test lung and verify the exhaled tidal volume monitor. Observe that the test lung (breathing bag) inflates as the bellows descends, and that the test lung deflates during the exhalation phase Observe that the measured exhaled volume matches the tidal volume set on the ventilator. With the ventilator running, lower the fresh gas flow to zero and observe if the bellows rapidly falls with each exhalation. If this occurs, then a leak should be suspected, identified, and repaired.

This test should be performed before starting each case. By verifying that a test lung (breathing bag) can be manually and mechanically ventilated, this indicates that the A5/A3 is capable of ventilating a patient with the attached breathing circuit.

4.3.2 Suggested Pre-Operative Checkout List

Below is a suggested checkout list that should be conducted before administering anesthesia. This is a guideline which users are encouraged to modify according to their local clinical practice. Such local modifications should have appropriate peer review. Users should refer to the A5/A3 Operating Instructions for special procedures, precautions, and step-by-step instructions.

WARNING: To ensure proper machine operation, user safety, and patient safety,

follow all checkout procedures established by the facility before administering anesthesia to the patient.

Each day before administering anesthesia, the following should be done:

1. With the anesthesia machine connected to AC Power, turn the Mains switch to ON and verify

that the unit is operating on AC. Follow the on-screen prompts to perform and complete the automatic machine start-up tests.

2. a. Check the O

(See “O2 Pipeline Test” on page 4-17.) b. Test low O (See “Test the O2 Concentration Monitoring and Alarms” on page 4-25. c. Test high and low airway pressure alarms. (See “Test the High Paw Alarm” on page 4-27.) (See “Test the Low Paw Alarm” on page 4-27.) d. Test low minute volume and apnea alarms. (See “Test the Low Minute Volume (MV) Alarm” on page 4-26. (See “Test the Apnea Alarm” on page 4-26.)

3. Verify that the O

exposure to 100% O See “Test the O2 Concentration Monitoring and Alarms” on page 4-25.

4. Check that the vaporizers are properly installed and sufficiently filled and that filler ports are

tightly closed. Verify that only one vaporizer turns ON at a time. (‘‘Install the Vaporizer’’ on page 2-5.)

Supply fail-safe message and alarm.

concentration alarm.

sensor displays approximately 21% in room air and above 94% after

4 - 4 046-003777-00 A5/A3™ Operating Instructions

Preoperative Tests Pre-Operative Checkout List

5. Perform a 40 cmH2O manual leak test. If present, set the left vaporizer to ON and perform a

40 cmH2O manual leak test. Set the vaporizer to OFF. Repeat for the right vaporizer if installed. (See “Manual Leak Test” on page 4-21.)

6. Perform a vaporizer leak test for each vaporizer installed on the A5/A3 system. (See “Manual

Leak Test” on page 4-21.)

7. Check that AGSS float moves freely. Set the vacuum flow so that the float position is

between the Min and Max lines. (‘‘Inspect the AGSS’’ on page 4-28.)

8. Drain any moisture from the breathing system water trap.

Prior to each patient, before administering anesthesia, the following should be done:

1. Inspect the A5/A3 for damage or hazardous conditions; ensure all necessary equipment and

supplies are present, e.g., drugs, CO

absorbent (not exhausted), breathing circuits and tank

wrench.

2. Check that central supply O2, N2O and Air pressures are each within the pipeline input range

specifications (i.e., 40 to 87 psi).

3. Check that O2, N2O and Air flowmeters operate properly: Check that all flow levels on the

monitor screen are at zero flow with flow-control valves closed. Adjust flow of all gases through their full ranges and check for erratic movements of the gas levels.

4. Check that a hypoxic mixture of less than 21% O

may not be administered: Attempt to

create an hypoxic O2/ N2O mixture by slowly opening the N2O flow control valve fully with the O2 flow valve fully closed (no N2O gas should be flowing). Then, slowly open the O2 flow valve and observe O

and N2O rise in proportion to maintain a minimum concentration of

21% O2 in fresh gas.

5. Perform a vaporizer leak test for each vaporizer installed on the A5/A3 system. (See “Manual

Leak Test” on page 4-21.)

6. Verify that Auxiliary O2 and Air are available and functioning.

7. Verify that a Self-inflating Manual Ventilation device is available and functioning.

8. Check that the O

, N2O, and Air cylinders (if present) are mounted on the A5/A3, have

adequate pressure, and no high pressure leaks are present. (See “Cylinder Tests” on page 4-19.)

9. Check that valves on the O

, N2O, and Air cylinders (if present) are closed until needed to

prevent unintentional use of gas.

10. With a breathing circuit and reservoir bag attached, check that the unidirectional valves

operate by visual inspection.

11. Check ventilation capability in Standby, Manual, VCV and PCV ventilator modes.

12. Check that patient suction is adequate to clear the airway.

13. Verify ability of required monitors and check alarms.

The following step is recommended to be performed when prompted by the machine:

• Complete the 21% O

Calibration.

(See “O2 Sensor Calibration” on page 7-6.)

A5/A3™ Operating Instructions 046-003777-00 4 - 5

System Self-Test Preoperative Tests

The following step is recommended when replacing an O2 sensor:

• Complete the 21% and 100% O (See “O2 Sensor Calibration” on page 7-6.)

The following step is recommended to be performed weekly, whenever a new vaporizer is installed or when CO

absorbent is replaced:

• Perform a vaporizer leak test. (See “Manual Leak Test” on page 4-21.)

4.4 System Self-Test

When the A5/A3 is powered on, it performs a self-test to ensure its alarm system (alarm LED, speaker, and buzzer) and hardware (flowmeter board, ventilator board, assistant ventilator board, power board, and CPU board) are properly functioning.

To perform a system self-test:

1. Turn the power switch on the front panel to the ON position. The A5/A3 powers up and

begins its system self-test. See Table 4-1 for the system self-test sequence.

After the system self-test is completed, the test results are displayed on the screen. Startup alarm messages also may be displayed.

See Table 4-2 for a list of possible test result conditions. See Table 6.6.1.1 for a list of Startup Alarm Messages.

2. Proceed to operate or troubleshoot the A5/A3 based on the self-test results.

Calibration.

SYSTEM SELF-TEST SEQUENCE COMMENTS

1. A high-pitched beep is sounded. Alarm self-test

2. The A5/A3 startup screen is displayed.

3. The LED above the touchscreen illuminates in sequence: red, yellow, and blue.

4. A test low priority alarm is sounded. Alarm self-test

5. The System Self-Test progress bar is displayed.

6. The System Self-Test is automatically started. Hardware self-test

7. The results of the System Self-Test are displayed.

Alarm self-test

TABLE 4-1 A5/A3 System Self-Test Sequence

4 - 6 046-003777-00 A5/A3™ Operating Instructions

Preoperative Tests System Self-Test

RESULT COMMENTS/OPTIONS

Pass condition Example:

The Pass condition indicates that the A5/A3 has passed the System Self-Test. No errors have been detected. Alarms and hardware are functioning properly.

Select Continue to enter the Automatic Circuit Leak and Compliance Test screen. or Select Skip to enter the Standby with automatic ventilation enabled.

All-Functional error condition Example:

Manual Only error condition Example:

The All-Functional error condition indicates that errors have been detected. However, all automatic ventilation, manual, and bypass modes are still enabled.

Select Accept to enter the Automatic Circuit Leak and Compliance Test screen. or Select Skip to enter the main screen with automatic ventilation enabled,

The Manual Only error condition indicates that the A5/A3 can be used in manual mode only.

Select Retry to repeat the System Self-Test. or Select Manual Only to place the device in manual ventilation mode only. The following low priority alarm will be displayed on the main screen: Automatic

Vent ilation Disabled.

WARNING: Selecting the “Manual

Only” button will disable automatic ventilation.

TABLE 4-2 Types of System Self-Test Results

A5/A3™ Operating Instructions 046-003777-00 4 - 7

System Self-Test Preoperative Tests

RESULT COMMENTS/OPTIONS

Machine Non-Functional error condition Example:

The Machine Non-Functional error condition indicates that the A5/A3 cannot be used.

Select Retry to repeat the System Self-Test. or Contact service if this error condition persists.

NOTE: The Service Access

button is only available to Mindray-authorized service personnel and requires a service password.

TABLE 4-2 Types of System Self-Test Results

Bundle Version – The Bundle Version is displayed in all System Self-Test results. The Bundle Version is the version number of the package of software that is installed in the A5/A3. If the Bundle Version displays a fail status, contact Mindray Technical Support.

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Mindray A3-A5 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual