A4-A5 Anesthesia System Operating Instructions Ver 13.0 Nov 2021

Operating Instructions ™

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™

Anesthesia System

A N E S T H E S I A S YS A TNEEM S T H E S I A S YS T E M

A5™ and A4™ are U.S. trademarks of Mindray DS USA, Inc. OPTIMIZER® is a registered trademark of Mindray DS USA, Inc SELECTATEC® is a registered trademark of Datex-Ohmeda, Inc.

Copyright © Mindray DS USA, Inc., 2018 to 2021. All rights reserved. Contents of this publication may not be reproduced in any form without permission of Mindray DS USA, Inc.

Table of Contents

Foreword ...ix Indications For Use ...ix Responsibilities of Operators ...ix Warnings, Cautions, and Notes ...ix Warnings...x Cautions... xiv Notes... xvii Intellectual Property Statement...xx Disclaimers...xx Phone Numbers and How To Get Assistance...xx Manufacturer’s Responsibility ... xxi Manufacturer and Address ...xxi Symbols... xxii

Product Description...1 - 1 General System Overview ...1 - 2 General Description...1 - 2 Key Features ...1 - 3 Fresh Gas Dosing ...1 - 4 Flow Control ...1 - 5 Vaporizer Mounting...1 - 5 Anesthesia Ventilator...1 - 5 Breathing System ...1 - 6 Active Anesthetic Gas Scavenging System ...1 - 7 Passive Anesthetic Gas Scavenging System (Optional)...1 - 7 Power Management / Battery Supply...1 - 7 Workplace Ergonomics...1 - 9 Hook ...1 - 9 Physical Views... 1 - 10 Main Unit (Front View)... 1 - 10 Main Unit (Rear View)... 1 - 12 Main Unit (Left View)... 1 - 14 Main Unit (Right View)... 1 - 15 Main Unit (Top View)... 1 - 16 Breathing System (Top View) ... 1 - 17 Breathing System (Left View) ... 1 - 18 Active Anesthetic Gas Scavenging System ... 1 - 20 Passive Anesthetic Gas Scavenging System (AGSS) (Right View) ... 1 - 23

Installation ...2 - 1 Unpacking...2 - 3 Initial Setup...2 - 4 Install the Vaporizer...2 - 5 Filling and Draining the Vaporizer ...2 - 7 Install the DGSS...2 - 8 Install the AGSS ... 2 - 10

System Interface ...3 - 1 Main Screen Components...3 - 2 System Information Header ...3 - 6 Elapsed / Countdown Timer...3 - 6 Patient Size ...3 - 7 Alarm and Prompt Messages ...3 - 7 Alarm Silence Icon...3 - 8 Date and Time ...3 - 9

A5/A4 Operating Instructions

i

Introduction

Battery Status ...3 - 10 Fresh Gas Flow Display ...3 - 11 Fresh Gas Flow Optimizer ...3 - 11 Waveforms Tab ...3 - 16 Waveforms Autoscaling...3 - 16 Waveforms Manual Scaling ...3 - 17 Spirometry Tab (A5 Only)...3 - 18 Loop Type ...3 - 20 Show Reference ...3 - 20 Save Loop...3 - 21 Review Loops Button...3 - 21 Demographics Tab ...3 - 23 Editing Patient Information...3 - 24 Loading Information from the ADT Server ...3 - 24 Associating Patient Information...3 - 25 Ventilation Mode Tabs ...3 - 26 Measured Values Area...3 - 29 System Softkeys...3 - 30 Setup Softkey...3 - 30 Alarms Softkey ...3 - 30 Silence Softkey ...3 - 30 Capture Event...3 - 30 Recruitment Softkey (A5 Only, Optional) ...3 - 30 History ...3 - 30 Setup ...3 - 37 General Tab ...3 - 37 Display Tab ...3 - 39 System Tab ...3 - 43 Network Configuration ...3 - 47 Service Tab ...3 - 51

Preoperative Tests ...4 - 1 Preoperative Test Schedules... 4 - 2 Test Intervals... 4 - 2 Inspect the System ... 4 - 3 Pre-Operative Checkout List ... 4 - 4 Introduction ... 4 - 4 Suggested Pre-Operative Checkout List... 4 - 4 System Self-Test ... 4 - 6 Leak and Compliance Tests... 4 - 9 Automatic Circuit Leak and Compliance Test... 4 - 9 Manual Circuit Leak Test...4 - 14 Preoperative Check List ...4 - 17 Power Failure Alarm Test ...4 - 18 Pipeline Tests...4 - 18 O2 Pipeline Test ...4 - 18 N2O Pipeline Test ...4 - 18 Air Pipeline Test ...4 - 19 Basic Ventilation Testing ...4 - 19 Cylinder Tests ...4 - 20 Check the Cylinder Pressure ...4 - 20 O2 Cylinder High Pressure Leak Test...4 - 20 N2O Cylinder High Pressure Leak Test (A5 Only) ...4 - 20

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A5/A3™ Operating Instructions

Air Cylinder High Pressure Leak Test ...4 - 20 Flow Control System Test ...4 - 21 Vaporizer Tests...4 - 22 Vaporizer Back Pressure Test ...4 - 22 Manual Leak Test...4 - 22 Vaporizer Leak Test ...4 - 22 Breathing System Tests...4 - 24 Bellows Test...4 - 24 Breathing System Leak Test in Manual Ventilation Status...4 - 24 APL Valve Test ...4 - 25 Alarm Tests...4 - 25 Prepare for Alarm Tests...4 - 25 Test the O2 Concentration Monitoring and Alarms...4 - 26 Test the Low Minute Volume (MV) Alarm ...4 - 26 Test the Apnea Alarm ...4 - 26 Test the Continuous Airway Pressure Alarm...4 - 27 Test the High Paw Alarm ...4 - 27 Test the Low Paw Alarm ...4 - 27 Preoperative Preparations...4 - 27 Inspect the Active/Passive Anesthetic Gas Scavenging System...4 - 28 Inspect the AGSS ...4 - 28 Inspect the DGSS...4 - 28 Inspect the Passive AGSS ...4 - 29

Operations...5 - 1 Powering On the A5/A4 Anesthesia System... 5 - 2 Powering Off the A5/A4 Anesthesia System... 5 - 2 Patient Setup ... 5 - 3 End Case / Standby Mode... 5 - 3 Select the Patient Size (Adult, Pediatric, Infant)... 5 - 5 Oxygen Sensor Calibration... 5 - 5 Input Fresh Gas ... 5 - 6 Set N2O, Air, and O2 Inputs... 5 - 6 Set Anesthetic Agent ... 5 - 7 Ventilation Modes... 5 - 8 Monitored Parameters ... 5 - 8 Ventilation Modes... 5 - 8 Change Ventilation Mode ... 5 - 8 Set Manual Ventilation Mode ... 5 - 9 Setting Monitor Mode (with AG Module connected) ...5 - 11 Make Settings before Starting Mechanical Ventilation Mode ...5 - 13 Volume Control Ventilation (VCV)...5 - 14 Pressure Control Ventilation (PCV) ...5 - 15 Set Pressure Regulated Volume Control Ventilation (PCV-VG) ...5 - 16 Synchronized Intermittent Mandatory Ventilation (SIMV) ...5 - 17 Continuous Positive Airway Pressure/Pressure Support Ventilation (CPAP/PS)...5 - 19 Airway Pressure Release Ventilation (APRV)...5 - 20 Lung Recruitment Maneuver (A5 Only) ...5 - 21 Start Mechanical Ventilation...5 - 25 Stop Mechanical Ventilation...5 - 25 Relationships of Ventilation Parameters ...5 - 25 Parameter Monitoring (Numerics)...5 - 26 Pressure ...5 - 26

A5/A4 Operating Instructions

iii

Table of Contents

Volume ... 5 - 26 Gas (available with the AG module) ... 5 - 27 Inspired O2 (available without the AG module) ... 5 - 27 Parameter Monitoring (Waveforms)... 5 - 28 Pressure Waveform... 5 - 28 Flow Waveform ... 5 - 28 Volume Waveform ... 5 - 29 Gas Waveform (available with the AG module) ... 5 - 29 Waveform Autoscaling ... 5 - 31 Parameter Monitoring (Spirometry, A5 Only) ... 5 - 32

Alarms and Messages ...6 - 1 Introduction ...6 - 2 Alarm System Self-Test...6 - 2 Types of Alarms and Messages...6 - 3 Alarm Indicators...6 - 4 Displaying Alarms ...6 - 5 Displayed Order of Alarm Messages...6 - 6 Setting Alarm Volume ...6 - 7 Silencing Alarms ...6 - 8 Alarm Limits...6 - 9 Setting Alarm Limits ...6 - 9 Loading Alarm Defaults... 6 - 12 Auto Alarm Limits... 6 - 14 Setting CO2 Apnea Delay Time ... 6 - 15 Alarm and Prompt Messages ... 6 - 16 Physiological Alarm Messages... 6 - 16 Technical Alarm Messages ... 6 - 19 Prompt Messages ... 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 O2 Sensor Calibration...7 - 7 Calibrate the O2 Sensor...7 - 8 Water Build-up in the Flow Sensor... 7 - 10 Prevent Water Build-up ... 7 - 10 Clear Water Build-up ... 7 - 10 Waste Gas Transfer Tube Maintenance ... 7 - 10 Electrical Safety Inspection ... 7 - 10 Auxiliary Electrical Outlet Test ... 7 - 10 Electrical Safety Inspection Test... 7 - 11 Cleaning and Disinfection... 7 - 12 General Guidelines... 7 - 12 Cleaning and Disinfecting Agents / Autoclaving... 7 - 12 External Surfaces... 7 - 13 Bellows Assembly... 7 - 13 Inspiration and Expiration Valves ... 7 - 16 Oxygen Sensor... 7 - 19 APL Valve ... 7 - 20 PAW Gauge... 7 - 21

iv

A5/A4 Operating Instructions

Bag Arm ...7 - 22 Absorber Canister ...7 - 23 Breathing System Block ...7 - 26 Active Anesthetic Gas Scavenging System...7 - 29 Regular Maintenance ...7 - 31

AG and O2 Concentration Monitoring (Optional) ...8 - 1 Introduction... 8 - 2 Identify External AG Modules... 8 - 3 Understand MAC Values... 8 - 4 Agent Usage Calculation... 8 - 5 Agent Usage Speed... 8 - 8 Prepare to Measure AG... 8 - 9 AG Module Settings ...8 - 10 Set CO2 Unit...8 - 10 Set CO2 Placement...8 - 10 Set CO2 Scale...8 - 10 Gas Bench Flow Rate...8 - 10 Set Alarm Limits...8 - 11 Measurement Limitations...8 - 12 Troubleshooting...8 - 12 Scavenge the Sample Gas...8 - 13 Calibrate the AG Module...8 - 13

Product Specifications...9 - 1 Standards Compliance... 9 - 2 Safety Designations ... 9 - 4 Oxygen Enriched Environments... 9 - 4 Wiring and PC Board Materials... 9 - 4 Physical Specifications ... 9 - 5 Stability Configurations and Conditions ... 9 - 5 Environmental Specifications... 9 - 6 Electrical Specifications ... 9 - 7 Main Electrical Power Specifications... 9 - 7 Battery Power Specifications ... 9 - 7 Auxiliary Electrical Outlets ... 9 - 8 Communication Ports ... 9 - 8 Pneumatic Specifications... 9 - 9 Pipeline Supply (N2O, Air, O2)... 9 - 9 Cylinder Supply (N2O (A5 Only), Air, O2)... 9 - 9 Vaporizer Connections... 9 - 9 Drive Gas ... 9 - 9 N2O Automatic Cutoff ... 9 - 9 O2 Controls ...9 - 10 Oxygen Ratio Controller ...9 - 10 Breathing System Specifications ...9 - 10 Breathing System Volume ...9 - 10 CO2 Absorber Assembly ...9 - 10 Water Trap ...9 - 10 Breathing System Connections...9 - 10 APL Valve...9 - 10 Resistance ...9 - 12 Breathing System Temperature Controller...9 - 13 Breathing Circuit Parameters...9 - 13

A5/A4 Operating Instructions

v

Table of Contents

Materials ... 9 - 13 Anesthetic Gas Scavenging System (AGSS)... 9 - 14 Monitor Module ... 9 - 14 AG Module ... 9 - 14 Alarms... 9 - 17 Effect of Interfering Gas on AG Measured Value... 9 - 18 Monitor Mode... 9 - 18 Agent Usage Calculation and Agent Usage Speed... 9 - 19 Ventilator Specifications ... 9 - 20 Displays and Controls Specifications ... 9 - 22 Electronic Controls... 9 - 22 Pneumatic Controls ... 9 - 24 Alarms... 9 - 25 Safety Specifications ... 9 - 26 ASTM F 1208 – 89 (2005) Disclosures... 9 - 27 Leakage of Breathing System... 9 - 27 Resistance of Breathing Systems ... 9 - 27 CO2 Absorber Resistance... 9 - 27 CO2 Absorber Capacity... 9 - 27 Unidirectional Valve Opening Pressure... 9 - 28 Data Storage (Non-Volatile) and Recording ... 9 - 28 Electromagnetic Compatibility ... 9 - 29

Accessories ...A - 1 Accessory Kits ... A - 2 AG Accessories ... A - 2 CO2 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 Scavenging Accessories... A - 5

User Accessible Spare Parts ...B - 1 Active AGSS ... B - 2 Breathing System ... B - 2 CO2 Absorbent Canister... B - 2 Flow Sensor ... B - 2 Gas Cylinder Accessories ... B - 3 O2 Sensor... B - 3 Battery ... B - 3

Parameters and Factory Defaults ...C - 1 Waveform/Spirometry Tabs (A5 Only)... C - 2 Alarm Limits... C - 3 Setup Menu ... C - 5 Alarm Volume ... C - 9 History ... C - 9 Date and Time ... C - 9 Demographics ... C - 9 Lung Recruitment (A5 only) ...C - 10 Ventilation Modes ...C - 10 Linked Ventilation Parameter ...C - 15

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A5/A4 Operating Instructions

Ventilation Parameter Relationships ... C - 18

Pneumatic Diagram ... D - 1 Pneumatic Diagram of the A5/A4 System ... D - 2

Abbreviations, Symbols, and Units of Measure ...E - 1 Abbreviations ... E - 2 Symbols ... E - 4 Units of Measure ... E - 4 Attention Symbols... E - 5

Preparation for Malignant Hyperthermia Susceptible Patients ...F - 1 Malignant Hyperthermia Causes, Effects and Treatment... F - 2 Malignant Hyperthermia Washout... F - 2 Washout Procedure for Malignant Hyperthermia Susceptible Patients with A5/A4 Anesthesia Delivery Systems ... F - 2 References ... F - 4

A5/A4 Operating Instructions

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Table of Contents

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A5/A4 Operating Instructions

Foreword

Introduction

Foreword WARNING:

Do not operate the A5/A4 Anesthesia System before reading these instructions.

The operating instructions for the A5/A4 Anesthesia Delivery System (hereinafter referred to as A5/A4 Anesthesia System, A5/A4 System, A5/A4, or individual A5 and A4) are intended to provide information for proper installation, operation, and general maintenance of the A5/A4 System to the user. General knowledge and understanding of the features and functions of the A5/A4 System are prerequisites for its proper use. For servicing information or assistance, please contact an authorized representative in your area. Rx only:

U.S. Federal Law restricts this device to sale by or on the order of a physician or other practitioner licensed by state law to use or order the use of this device.

NOTE:

Figures in this manual are provided for reference purposes only. Screens may differ based on the system configuration and selected parameters.

NOTE:

This operating instructions is suitable for the Anesthesia System with software bundle version 03.00.00 and later.

Indications For Use The A5/A4 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/A4 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric (including neonate, infant, child and adolescent) populations. WARNING:

The A5/A4 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/A4.

WARNING:

The A5/A4 is not suitable for use in an MRI environment.

Responsibilities of Operators The proper function of the A5/A4 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/A4 System must be operated by qualified and trained personnel only. All operators must fully observe these operating instructions and relevant additional documentation. They must also comply with the WARNINGS, CAUTIONS, and NOTES detailed in this manual.

Warnings, Cautions, and Notes Please adhere to all warnings, cautions, and notes that are listed throughout this manual. They are summarized here for your reference. WARNING - Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury to the patient or user. CAUTION - Indicates a potential hazard or unsafe practice that, if not avoided, could result in product/property damage or minor personal injury to the patient or user.

A5/A4 Operating Instructions

ix

Introduction

Warnings

NOTE - Provides application tips or other useful information.

Warnings

x

WARNING:

Do not operate the A5/A4 Anesthesia System before reading these instructions.

WARNING:

All analog or digital products connected to this system must be certified passing the specified IEC standards (such as IEC 60950 for data processing equipment and IEC 60601-1 for medical electrical equipment). All configurations shall comply with the valid version of IEC 60601-1. The personnel who are responsible for connecting the optional equipment to the I/O signal port shall be responsible for medical system configuration and system compliance with IEC 60601-1.

WARNING:

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

WARNING:

Before putting the system into operation, the operator must verify that the equipment, connecting cables, and accessories are in correct working order and operating condition.

WARNING:

The equipment must be connected to a properly installed power outlet with protective earth contacts only. If the installation does not provide for a protective earth conductor, disconnect it from the power line or operate from the equipment’s internal battery supply.

WARNING:

Multiple AC power outlets are provided on the rear of the A5/A4. These outlets are intended to supply power to additional equipment that form a part of the anesthesia system (i.e. vaporizers, gas analyzers, etc.). Do not connect other equipment to these outlets, as patient leakage current may be affected. Each outlet is rated 3 A; the total current that may be drawn through all outlets is 10 A on the A5 System and 9 A on the A4 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/A4 Anesthesia System to an AC power source before the internal battery power source is depleted.

WARNING:

Do not open the equipment housings. All servicing and future upgrades must be carried out only by trained and authorized Mindray personnel.

WARNING:

Do not rely exclusively on the audible alarm system for patient monitoring.

WARNING:

Adjustment of alarm volume to a low level may result in a hazard to the patient.

WARNING:

Alarm settings should be customized according to different patient situations. Constantly keeping the patient under close surveillance is the most reliable way for safe patient monitoring.

WARNING:

The physiological parameters and alarm messages displayed on the screen of the equipment are for the caregiver’s reference only and cannot be directly used as the basis for clinical treatment.

WARNING:

Dispose of the packaging material, observing the applicable waste control regulations and keeping it out of children’s reach.

A5/A4 Operating Instructions

Warnings

Introduction

WARNING:

To avoid the possibility of explosion, do not use the equipment in the presence of flammable anesthetic agents, vapors or liquids. Do not use flammable anesthetic agents such as ether and cyclopropane for this equipment. Use only non-flammable anesthetic agents that meet the requirements specified in ISO 80601-2-13. The A5/A4 Anesthesia System can be used with halothane, enflurane, isoflurane, sevoflurane, and desflurane. Only one anesthetic agent can be used at a time.

WARNING:

Fresh gas flow must never be switched off before the vaporizer is switched off. The vaporizer must never be left switched on without a fresh-gas flow. Anesthetic agent vapor at a high concentration can get into the machine lines and ambient air, causing harm to people and materials.

WARNING:

To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

WARNING:

The use of anti-static or electrically conductive breathing tubes, when utilizing high frequency electric surgery equipment, may cause burns, and is therefore not recommended in any application of this machine.

WARNING:

Possible electric shock hazard. The machine may only be opened by authorized service personnel.

WARNING:

The patient should be visually monitored by qualified personnel. In certain situations, life-threatening circumstances may occur that may not necessarily trigger an alarm.

WARNING:

Always set the alarm limits so that the alarm is triggered before a hazardous situation occurs. Incorrectly set alarm limits may result in operating personnel not being aware of drastic changes in the patient’s condition.

WARNING:

Connection of both medical and non-medical equipment to the auxiliary mains socket outlet (s) may increase the leakage currents to values exceeding the allowable limits.

WARNING:

Electric shock and fire hazard: Do not clean the machine while it is powered on and/or plugged into an outlet.

WARNING:

Disconnect the power plug from the mains supply before removing the rear panels or servicing the A5/A4 unit.

WARNING:

Malfunction of the central gas supply system may cause more than one or even all devices connected to it to stop their operation simultaneously.

WARNING:

The anesthesia system will cease to deliver gas at pressures below the minimum specified gas pipeline supply pressure.

WARNING:

Use a cleaning and disinfection schedule that conforms to your institution's disinfection and risk-management policies.

WARNING:

A5/A4 Operating Instructions

•

Refer to the material safety data sheet as applicable.

•

Refer to the operation and maintenance manuals of all disinfection equipment.

•

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

Use extreme care while handling the absorbent as it contains a caustic irritant.

xi

Introduction

xii

Warnings

WARNING:

Use care in lifting and manipulating vaporizers during the mounting process as their weight may be greater than expected, based on their size and shape.

WARNING:

Do not use talc, zinc stearate, calcium carbonate, corn starch, or similar material to prevent sticking of the bellows, as these materials may enter the patient's lungs or airway, causing irritation or injury.

WARNING:

All gas supplies should be of medical grade.

WARNING:

Single use respiratory hoses, face masks, sensors, sodalime, water traps, sampling lines, airway adapters, and other single use items may be considered potential biologically hazardous items and should not be reused. Dispose of these items in accordance with hospital policy and local regulations for contaminated and biologically hazardous items.

WARNING:

To avoid endangering a patient, do not perform testing or maintenance when the machine is in use.

WARNING:

Review the performance specifications of the disposal system that the transfer and receiving systems are intended to be used with, to ensure compatibility.

WARNING:

The A5/A4 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the A5/A4 should be observed to verify normal operation in the configuration in which it will be used.

WARNING:

Ensure that the current alarm presets are appropriate before use on each patient.

WARNING:

A hazard can exist if different alarm presets are used for the same or similar equipment in any single area.

WARNING:

Due to the size and weight of the A5/A4, 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/A4. Before moving, remove all equipment from the top shelf and all monitoring equipment mounted to the side of the A5/A4. Use care when moving the A5/A4 up or down inclines, around corners, and across thresholds. Do not attempt to roll the A5/A4 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/A4 exhaust port to the hospital’s waste gas scavenging system is strongly recommended to prevent exposure of hospital personnel to the A5/A4 exhaust gases.

WARNING:

Operation of the A5/A4 below the minimum flow values may cause inaccurate results.

WARNING:

Ensure that an independent means of ventilation (e.g. a self-inflating manually powered resuscitator with mask) is available whenever the A5/A4 is in use.

A5/A4 Operating Instructions

Warnings

Introduction

WARNING:

Usage of accessories found with damaged packaging may cause biocontamination or failure. The operator should check accessory packaging integrity before use.

WARNING:

Before using the A5/A4 System (after cleaning or disinfecting), power up the system and follow the on-screen prompts to perform the leak test and the compliance test. (see section 4.5 (page 4-9) "Leak and Compliance Tests".)

WARNING:

Improperly cleaned materials may result in biocontamination. Use a cleaning and disinfection schedule that conforms to your institution's disinfection and risk-management policies. • Refer to the material safety data as applicable. • Refer to the operation and maintenance manuals of all disinfection equipment. The user should follow the recommended disinfection routine for this machine and any reusable accessories.

WARNING:

If the A5/A4 is damaged in any way that compromises the safety of the patient or user, discontinue use and attach a visible tag that marks the A5/A4 as unusable. Call Mindray Technical Support.

WARNING:

Oxygen, when present in high concentrations, can significantly increase the chance of fire or an explosion. Oil and grease may spontaneously ignite and should not be used where oxygen enrichment may occur.

WARNING:

Use of lubricants not recommended by Mindray may increase the danger of fire or explosion. Use lubricants approved by Mindray.

WARNING:

Low-pressure regulators and flow-meters are susceptible to high pressure, and may burst if improperly maintained or disassembled while under pressure. Changing connectors or disassembling should be performed only by qualified personnel.

WARNING:

Do not disassemble the low-pressure regulator, flow-metering device, or connector while under pressure. The release of sudden pressure may cause injury.

WARNING:

Review the specifications of the AGSS transfer and receiving systems and the specifications of the A5/A4 System to ensure compatibility and to prevent a mismatched receiving system.

WARNING:

Avoid connecting two or more hose assemblies in series as this may cause a loss of pressure and flow.

WARNING:

A hazard may exist due to the use of improper connectors. Ensure all assemblies use the proper connectors.

WARNING:

Avoid replacing a high-pressure flexible connection with one of lower nominal inlet pressure.

WARNING:

Reusing breathing circuits or reusable accessories that are not disinfected may cause cross-contamination. Disinfect the breathing circuits and reusable accessories before use.

WARNING:

Inspect all breathing system components carefully before each use. Ensure all components do not contain any obstructions or debris that can cause a potential hazard to the patient.

WARNING:

Use breathing circuits and manual bags in accordance with ASTM F1208 and compatible with standard 22mm male conical fittings per ASTM specifications F 1054.

A5/A4 Operating Instructions

xiii

Introduction

Cautions

WARNING:

The mains plug is used to isolate the Anesthesia System circuits electrically from the SUPPLY MAINS. Do not position the Anesthesia System so that it is difficult to operate the plug.

WARNING:

Do not touch the patient when connecting the peripheral equipment via the I/O signal ports or replacing the oxygen cell to prevent patient leakage current from exceeding the requirements specified by the standard.

WARNING:

If the Drive Gas Pressure Low alarm occurs when the gas supply pressure is greater than 200 kPa, contact your service personnel or us.

WARNING:

The anesthesia system shall not be serviced or maintained while being connected on a patient.

WARNING:

Additional MULTIPLE SOCKET- OUTLET or extension cord shall not be connected to the ME SYSTEM.

WARNING:

If the change in altitude is great, contact Mindray Technical Support for flow calibration (service). Great change in altitude may affect tidal volume measurement accuracy.

WARNING:

Do not use the Optimizer when higher flows are required such as during induction, emergency, or other times when rapid changes to the concentration of gases in the circuit are desired, or when the chemical pharmacology of the agent being used indicates otherwise. If the Optimizer is used incorrectly, the reaction time of fresh gas concentration changes could increase, also increasing the risk of undesirable soda lime compounds.

WARNING:

To avoid electric shock and cutting, stop using the equipment if you find the housing is damaged, and contact your service personnel.

Cautions

xiv

CAUTION:

To ensure patient safety, use only parts and accessories specified in this manual.

CAUTION:

At the end of its service life, the equipment, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products, and in accordance with local regulations for contaminated and biologically hazardous items.

CAUTION:

Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. Ensure that all external devices operating in the vicinity of the equipment comply with the relevant EMC requirements. Mobile phones, x-ray equipment, and MRI devices are possible sources of interference as they may emit higher levels of electromagnetic radiation.

CAUTION:

This system operates correctly at the electrical interference levels identified in this manual. Higher levels can cause nuisance alarms that may stop mechanical ventilation. Be aware of false alarms caused by high-intensity electrical fields.

CAUTION:

The A5/A4 Anesthesia System may become unstable if the unit is tilted beyond 10 degrees. Use extreme caution when moving or resting the unit on surfaces exceeding a 10 degree slope. Do not hang articles on the sides of the unit that would cause an excessive imbalance.

CAUTION:

Perform the daily checks specified on the checklist. In case of a system fault, do not operate the system until the fault has been corrected.

A5/A4 Operating Instructions

Cautions

Introduction

CAUTION:

Before starting the machine, users must be familiar with the information contained in these Operating Instructions and must have been trained by an authorized representative.

CAUTION:

If the machine does not function as described, it must be examined and repaired as necessary by qualified service personnel before being returned to use.

CAUTION:

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

CAUTION:

Ensure that the gas supply of the machine always complies with the technical specifications.

CAUTION:

Before clinical use, the machine must be correctly calibrated and/or the respective tests must be performed, as described in these Operating Instructions.

CAUTION:

If system faults occur during the initial calibration or testing, the machine should not be operated until those faults have been corrected by a qualified service person.

CAUTION:

After servicing, functional, sensor, and system tests must be performed before clinical use.

CAUTION:

Only vaporizers with Selectatec Interlock-Systems may be used with the A5/A4 unit.

CAUTION:

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

CAUTION:

Use cleaning agent sparingly. Excess fluid could enter the machine, causing damage.

CAUTION:

Do not autoclave any parts of the A5/A4 unless specifically identified as autoclavable in this manual. Clean the A5/A4 only as specified in this manual.

CAUTION:

To prevent system damage:

CAUTION:

•

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.

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

Dispose of the oxygen sensor as per the local regulations.

CAUTION:

Do not use acetic hydroperoxide or formaldehyde steaming.

CAUTION:

The valve disc in each of the inhalation and exhalation valve assemblies on the breathing system is fragile and must be handled with care while removing the valve cage from the valve assembly.

A5/A4 Operating Instructions

xv

Introduction

xvi

Cautions

CAUTION:

If moisture remains in the bellows after cleaning, the bellows surface folds may become tacky and prevent the bellows from properly expanding. Ensure all moisture is removed from the bellows after cleaning.

CAUTION:

Only connect Mindray approved equipment to the A5/A4 communication ports. Equipment connected to the A5/A4 ethernet ports must comply with IEC 60950.

CAUTION:

Do not connect any non-isolated devices to the DB9/RS232C interface of the A5/A4.

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 (FiO2%) when using the Auxiliary O2/Air Flow Meters. Unknown oxygen concentrations may be delivered to the patient unless oxygen monitoring is used.

CAUTION:

The A5/A4 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/A4, use only Mindray-approved cables and accessories.

CAUTION:

Use the power cord provided with the product. If a substitute is necessary, use only hospital grade power cords.

CAUTION:

Do not use a damaged or broken unit or accessory. Periodically check all cables (e.g., AC line cord and patient connection cables) for damage that may occur through normal use. Replace cables if damaged in any way.

CAUTION:

Use of other oxygen sensors may cause improper oximeter performance.

CAUTION:

Unintended movement may occur if the casters are not locked. The operator should lock casters during use of the machine.

CAUTION:

Unsecured devices may slide off the top shelf. Devices should be securely attached to the top shelf.

CAUTION:

The voltage on the auxiliary outlets is the same voltage as the outlet into which the A5/A4 machine is plugged. Ensure that devices plugged into the auxiliary outlets are rated for the same supply voltage as the A5/A4.

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/A4. The flow outlets may become damaged. Use the metal side bars on the main body when moving the A5/A4.

A5/A4 Operating Instructions

Notes

Introduction

CAUTION:

Do not push down on the bag arm forcefully or hang heavy objects onto it. Excessive weight may bend and damage the bag arm.

CAUTION:

Use caution when disconnecting “quick connectors”, as the sudden release of pressure may cause injury.

CAUTION:

Avoid factors that can contribute to deterioration of the hose assemblies. Factors include excessive bending, crushing, abrasion, system pressures and temperatures that exceed hose ratings, and improper installation.

CAUTION:

Use care in lifting and manipulating the breathing system block during removal from its mounting arm as handling may be awkward due to its weight and shape.

CAUTION:

Turn the flow controls slowly. To avoid damaging the control valves, do 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. Screens may differ based on the system configuration and selected parameters.

NOTE:

Put the equipment in a location where you can easily see the screen and 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. 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/A4 is intended to be operated with its integral Breathing Pressure monitoring in use.

NOTE:

The A5/A4 is intended to be operated with its integral Breathing Pressure limitation devices in use.

NOTE:

The A5/A4 is intended to be operated with its integral Exhaled Volume monitoring in use.

NOTE:

The A5/A4 is intended to be operated with its integral Breathing System integrity Alarm System in use.

NOTE:

The A5/A4 is intended to be operated with its integral Continuing Pressure Alarm in use.

A5/A4 Operating Instructions

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