Mindray A3-A5 User manual

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

+ 254 hidden pages