A8 Anesthesia System Operating Instructions Ver 11.0 Jan 2022

Operating Instructions 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

Anesthesia System

OPTIMIZER® is a registered trademark of Mindray DS USA, Inc. Selectatec® is a registered trademark of Datex-Ohmeda Inc.

Copyright © Mindray DS USA, Inc., 2020-2021. All rights reserved. Contents of this publication may not be reproduced in any form without permission of Mindray DS USA, Inc.

Table of Contents

Table of Content Safety ... 1 - 1 Safety Information ...1 - 2 Warnings...1 - 2 Cautions ...1 - 7 Notes ...1 - 10 Symbols...1 - 11

Product Description... 2 - 1 Introduction ...2 - 2 Indications For Use...2 - 2 Structure and Composition ...2 - 2 Functions and Features...2 - 2 Equipment Views...2 - 4 Main Unit (Front View)...2 - 4 Main Unit (Rear View)...2 - 7 Main Unit (Left View)...2 - 9 Main Unit (Right View)...2 - 11 Main Unit (Top View)...2 - 12 Breathing System ...2 - 13 Negative Pressure Suction Device...2 - 14

Installation and Disassembly... 3 - 1 Unpacking...3 - 3 Initial Setup...3 - 3 Breathing System ...3 - 3 Vaporizer ...3 - 4 Filling and Draining the Vaporizer ...3 - 5 Negative Pressure Suction Device...3 - 5 Turn on Negative Pressure Suction Device...3 - 6 Turn off Negative Pressure Suction Device...3 - 6 High-flow Nasal Cannula Oxygen (HFNC) Tube ...3 - 7 Anesthetic Gas Scavenging System (AGSS)...3 - 8 Active AGSS ...3 - 8 Passive AGSS ...3 - 9 Connect Anesthesia System with Information System ...3 - 11 Connect Anesthesia System with Information System Through Serial Interface ...3 - 11 Connect Anesthesia System with Information System Through Ethernet...3 - 11 Connect Anesthesia System to Patient Monitor ...3 - 12 Connect Anesthesia System to Patient Monitor Through Serial Interface ...3 - 12 Connect Anesthesia System with eGateway...3 - 12

System Interface ... 4 - 1 Main Screen ...4 - 2 System Information Title ...4 - 3 Patient Information...4 - 3 Set Patient Information in Anesthesia System ...4 - 5 Retrieve Patient Information from ADT Server ...4 - 5 Synchronize Patient Information ...4 - 5 Timer (Elapsed Timer/Countdown Timer)...4 - 6 Alarm and Prompt Message ...4 - 7 Audio Pause/Alarm Reset icon ...4 - 7 Screen Brightness...4 - 8 Volume ...4 - 8

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Table of Contents

Date and Time ...4 - 8 Battery Status...4 - 9 Fresh Gas Flow Display...4 - 10 Electronic Flow Control System ...4 - 10 Total Flow Control Mode ...4 - 11 Direct Flow Control mode ...4 - 12 OPTIMIZER® ...4 - 13 Backup Flow Control System...4 - 15 Waveform/Parameter/Spirometry/Trend Display Zone...4 - 15 Waveform/Parameter Screen...4 - 17 Spirometry Screen...4 - 17 Loop Type ...4 - 18 Show Reference ...4 - 18 Save Loop ...4 - 19 Review Loops ...4 - 19 Mini Trends Screen...4 - 20 Compl/PEEP Trend Screen ...4 - 21 Ventilation Mode Tabs...4 - 22 System Soft Key...4 - 22 History...4 - 23 List Trends ...4 - 23 Graphic Trends ...4 - 24 Event Log ...4 - 25 Screen ...4 - 25 Export ...4 - 26 Lung Recruitment (Optional) ...4 - 26 Flow Pause ...4 - 26 Cardiac Bypass Mode ...4 - 27 Screens ...4 - 27 Alarms...4 - 27 Alarm Reset...4 - 27 Audio Pause...4 - 27 Setup Menu ...4 - 27 Ventilation...4 - 28 Oxygen (O2)...4 - 30 AG Settings (AG module configured)...4 - 30 Information...4 - 30 Screen ...4 - 32 Export System Data ...4 - 33 Calibrate...4 - 34 System ...4 - 34 Calibrate ...4 - 34 Setup ...4 - 36 Profiles ...4 - 39 Network ...4 - 41 Information ...4 - 44 Service Tab...4 - 44 Status Screen...4 - 45 Volume Exchanger ...4 - 45 Automatic Ventilation, Flow Pause or Bypass ...4 - 45 Manual Ventilation ...4 - 45 Gas Supply Pressure Monitoring...4 - 45

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AGSS ...4 - 46

Preoperative Tests... 5 - 1 Requirements of Preoperative Tests ...5 - 2 Preoperative Checklist...5 - 3 Introduction...5 - 3 Suggested Preoperative Checklist ...5 - 3 Inspect the System...5 - 5 System Check...5 - 6 Auto System Check...5 - 6 Leak & Compliance Test ...5 - 7 Power Failure Alarm Test...5 - 7 Pipeline Test ...5 - 7 O2 Pipeline Test...5 - 7 N2O Pipeline Test...5 - 7 Air Pipeline Test...5 - 8 Basic Ventilation Test ...5 - 8 Backup Gas Cylinder Test ...5 - 9 Check Cylinder Pressure...5 - 9 High Pressure Leak Test of O2 Cylinders ...5 - 9 High Pressure Leak Test of N2O Cylinders ...5 - 9 High Pressure Leak Test of Air Cylinders...5 - 10 Flow Control System Test...5 - 10 Vaporizer Test ...5 - 12 Vaporizer Back Pressure Test...5 - 12 Vaporizer Leak Test...5 - 12 Breathing System Test...5 - 13 Inspiratory and Expiratory Check Valve Tests ...5 - 13 APL Valve Test...5 - 13 Alarm Test ...5 - 14 Prepare for Alarm Tests ...5 - 14 O2 Concentration Monitoring and Alarm Test...5 - 14 Minute Volume (MV) Too Low Alarm Test...5 - 15 Apnea Alarm Test ...5 - 15 Continuous Airway Pressure Too High Alarm Test...5 - 16 Airway Pressure (Paw) Too High Alarm Test...5 - 16 Airway Pressure (Paw) Too Low Alarm Test ...5 - 16 AG Module Alarm Test...5 - 16 Inspect the AGSS ...5 - 17 Check Passive AGSS...5 - 17 Inspect the Negative Pressure Suction Device ...5 - 17 Pre-operation Preparations ...5 - 17

Operations... 6 - 1 Powering On the Anesthesia System...6 - 2 Powering Off the Anesthesia System...6 - 2 Patient Setup...6 - 3 Standby Mode ...6 - 3 Enter Standby mode ... 6 - 3 Exit Standby mode ... 6 - 4 Set Patient Information ...6 - 4 O2 Sensor Calibration...6 - 4 Set Fresh Gas...6 - 4 Set O2, N2O and Air Inputs ...6 - 4

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Table of Contents

Set Anesthetic Agent ...6 - 4 Select the Desired Anesthetic Agent ...6 - 5 Adjust the Concentration of Anesthetic Agent ...6 - 5 Set Ventilation ...6 - 5 Change Ventilation Mode ...6 - 5 Set Manual Ventilation Mode...6 - 6 Settings Before Starting the Automatic Ventilation Mode...6 - 7 Volume Control Ventilation (VCV) ...6 - 7 Set Pressure Control Ventilation (PCV) ...6 - 8 Set Pressure Control Ventilation - Volume Guarantee (PCV-VG)...6 - 9 Synchronized Intermittent Mandatory Ventilation (SIMV)...6 - 9 Synchronized Intermittent Mandatory Ventilation–Volume Control (SIMV-VC) ...6 - 10 Synchronized Intermittent Mandatory Ventilation–Pressure Control (SIMV-PC) ...6 - 10 Synchronized Intermittent Mandatory Ventilation–Volume Guarantee (SIMV-VG) ...6 - 10 Set Continuous Positive Airway Pressure/Pressure Support Ventilation (CPAP/PS)...6 - 13 Set Airway Pressure Release Ventilation (APRV) (Optional) ...6 - 14 Lung Recruitment Ventilation (Optional) ...6 - 14 One-Step Recruitment ...6 - 15 Multi-Step Recruitment ...6 - 16 Parameter Monitoring ...6 - 17 Freeze Trend ...6 - 17 Other Features...6 - 17 Auxiliary Common Gas Outlet (ACGO) Mode...6 - 17 Monitor...6 - 18 Cardiac Bypass Mode ...6 - 19 High-flow Nasal Cannula Oxygen (HFNC) ...6 - 19 Start Automatic Ventilation...6 - 20 Stop Automatic Ventilation ...6 - 21 Relationships of Ventilation Parameters...6 - 21

Anesthetic Gases and O2 Concentration Monitoring ... 7 - 1 Introduction ...7 - 2 MAC Values...7 - 3 Agent Usage Calculation ...7 - 4 Agent Consumption Speed ...7 - 4 Identify External AG Module ...7 - 5 AG Measurement Preparation ...7 - 6 AG Module Settings...7 - 7 Set Operating Mode ...7 - 7 Set AG Flow Rate...7 - 7 Set CO2 Unit...7 - 7 Set CO2 Scale...7 - 7 Set O2 Scale...7 - 7 Set N2O Scale ...7 - 7 Set AA Scale ...7 - 8 Set Alarm Limits ...7 - 8 Measurement Limits...7 - 9 Troubleshooting ...7 - 10 Sample Gas Recirculation...7 - 10 Calibrate the AG Module ...7 - 11

Alarms and Messages ... 8 - 1 Introduction ...8 - 2 Alarm System Self-Test...8 - 2

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Table of Contents

Types of Alarms and Messages...8 - 2 Alarm Indicators...8 - 2 Alarm Display...8 - 4 Display Rules of Alarm Messages...8 - 5 Setting Alarm Volume ...8 - 6 Pause Alarm Audio...8 - 7 Alarm Reset...8 - 7 Setting Alarm Limits ...8 - 8 Auto Alarm Limits...8 - 10 View Active Alarms ...8 - 11 Alarms and Prompt Messages ...8 - 12 Physiological Alarm Messages...8 - 12 Technical Alarm Messages ...8 - 18 Startup Alarm Messages ...8 - 18 CPU Board Runtime Alarm ...8 - 21 Power Supply Board Runtime Alarm ...8 - 22 Flow Control System Runtime Alarm ...8 - 23 Ventilator Control Board Runtime Alarm ...8 - 24 AG Module Alarm Messages ...8 - 27 AGSS Alarms ...8 - 29 HFNC Module Alarms ...8 - 29 Prompt Message ...8 - 29 Prompt Messages Displayed in Alarms Area ...8 - 29

Maintenance ... 9 - 1 Maintenance Schedule...9 - 3 Breathing System Service...9 - 3 Flow Sensor Calibration ...9 - 4 O2 Sensor Calibration...9 - 4 21% Oxygen Calibration ...9 - 4 100% O2 Calibration...9 - 5 O2 Sensor Calibration Error Codes...9 - 6 Handling of Gathered Water ...9 - 7 Avoid Water Gathering...9 - 7 Clear Gathered Water...9 - 7 Electrical Safety Inspection ...9 - 7 Auxiliary Outlet Test ...9 - 8 Electrical Safety Test...9 - 8 Cleaning and Disinfection...9 - 8 Cleaning Agents and Disinfectors/Autoclaving ...9 - 9 Exterior ...9 - 10 Breathing System ...9 - 10 Disassembly ...9 - 11 Cleaning and Disinfection (Choose One) ...9 - 18 Autoclaving (Additional Reprocessing) ...9 - 19 Reassembly ...9 - 19 Check Before the Next Use ...9 - 28 Negative Pressure Suction Device...9 - 28 Disassembly ...9 - 28 Cleaning ... 9 - 28 Disinfection ... 9 - 29 Reassembly ...9 - 29 Check Before the Next Use ...9 - 29

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Table of Contents

Periodic Maintenance ...9 - 30

Product Specifications... 10 - 1 Standards Compliance ... 10 - 2 Safety Designations... 10 - 4 Physical Specifications... 10 - 4 Environmental Specifications ... 10 - 6 Electrical Specifications... 10 - 6 Main Electrical Power Specifications ... 10 - 6 Battery Power Specifications... 10 - 7 Auxiliary Electrical Outlets... 10 - 8 Communication Ports... 10 - 8 Pneumatic Specifications ... 10 - 8 Pipeline Supply... 10 - 8 Cylinder Supply ... 10 - 9 Auxiliary Common Gas Outlet (ACGO) ... 10 - 9 Anesthetic Vaporizer ... 10 - 9 Drive Gas... 10 - 9 O2 Controls ... 10 - 9 Breathing System Specifications ... 10 - 9 Breathing System Volume... 10 - 9 Volume Exchanger Volume ... 10 - 10 CO2 Absorber Assembly... 10 - 10 Breathing System Connections ... 10 - 10 APL Valve ... 10 - 11 Resistance... 10 - 12 Breathing System Temperature Controller... 10 - 14 Breathing Circuit Parameters ... 10 - 14 Unidirectional Valve Opening Pressure... 10 - 14 Anesthetic Gas Scavenging System (AGSS)... 10 - 14 Negative Pressure Suction device ... 10 - 14 Monitor Module ... 10 - 15 AG Module ... 10 - 15 Alarms ... 10 - 18 Effect of Interfering Gas on AG Measured Value ... 10 - 19 Monitor Mode... 10 - 20 Oxygen Monitor Using Oxygen Cell ... 10 - 20 Alarms ... 10 - 20 Effect of Interfering Gas on Oxygen Cell Measured Value ... 10 - 20 Agent Usage Calculation and Agent Usage Speed... 10 - 20 Ventilator Specifications ... 10 - 21 Displays and Controls Specifications ... 10 - 24 Electronic Controls... 10 - 24 Pneumatic Controls ... 10 - 24 Alarms... 10 - 25 Response Time of the Anesthesia System to an Increase in O2 Concentration (From 21% to 90%/100%)... 10 - 26

Accessories ...A - 1 Parameters and Factory Defaults ... B - 1 Spirometry Screen...B - 2 Limits...B - 2 Main Menu ...B - 3 Screen Brightness...B - 6 Volume ...B - 6

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Table of Contents

History ...B - 6 Lung Recruitment ...B - 6 Fresh Gas Control ...B - 6 Patient Information ...B - 7 Ventilation Mode...B - 7 Ventilation Linkage Parameters ...B - 10 Constraints Among Ventilation Parameters...B - 14

Operating Principles... C - 1 Pneumatic Diagram...C - 2 Electric System Structure...C - 6

Abbreviations, Symbols, and Units of Measure ...D - 1 Abbreviations ... D - 2 Symbols... D - 3 Units of Measure... D - 3

Electromagnetic Compatibility... E - 1 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 Anesthesia Delivery Systems ... F - 2 References... F - 4

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Anesthesia System Operator’s Manual

Intellectual Property Statement

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.

Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

, and are the trademarks, registered or otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners. This posting serves as notice under 35 U.S.C.§287(a). for Mindray patents: http:// www.mindrayna.com/patents.

Responsibility on the Manufacturer Party Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this product, only if: •

all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;

•

the electrical installation of the relevant room complies with the applicable national and local requirements; and

•

the product is used in accordance with the instructions for use.

WARNING:

It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

NOTE:

This equipment must be operated by skilled/trained clinical professionals.

Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to:

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Phone Numbers and How To Get Assistance

•

Malfunction or damage caused by improper use or man-made failure.

•

Malfunction or damage caused by unstable or out-of-range power input.

•

Malfunction or damage caused by force majeure such as fire and earthquake.

•

Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.

•

Malfunction of the instrument or part whose serial number is not legible enough.

•

Other malfunctions not caused by instrument or part itself.

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 877.913.9663 (toll free) for Technical Support or 650.316.3199 (outside North America) for assistance in determining the nearest field service location. Please include the instrument model number, the serial number (located on the back of the Anesthesia System), 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 Anesthesia System which are designated as repairable.

Manufacturer and Address

x

Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address:

Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan, Shenzhen 518057, P.R. China

Anesthesia System Operator’s Manual

Foreword

Foreword The Operator’s Manual for the A8 Anesthesia System (herein referred to as Anesthesia System, Equipment, A8) contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any question, please contact us. This manual is an integral part of the product. It should always be kept close to the equipment so that it can be obtained conveniently when needed.

Intended Audience This manual is for clinical professionals who are expected to have a working knowledge of medical procedures, practices and terminology as required for monitoring of critically ill patients.

Illustrations All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your anesthesia system.

Responsibilities of Operators The proper function of the Anesthesia 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 Anesthesia System must be operated by qualified and trained personnel only. All operators must fully observe this operator’s manual and relevant additional documentation. They must also comply with the WARNINGS, CAUTIONS, and NOTES detailed in this manual.

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Responsibilities of Operators

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Anesthesia System Operator’s Manual

1.0

Safety

Safety Information...1-2 Symbols ... 1-11

Operator’s Manual of Anesthesia System

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Safety Information

1.1

Safety

Safety Information WARNING - Indicates a potential hazard or unsafe practice that, if not avoided, could result in death, serious injury or property damage to the patient or user. CAUTION - Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury, product malfunction, damage or property loss to the patient or user. NOTE - Provides application tips or other useful information to ensure that you get the most from your product.

1.1.1

1-2

Warnings WARNING:

Do not operate the anesthesia system before reading this manual.

WARNING:

All analog or digital equipment 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 equipment 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 equipment. These outlets are intended to supply power to additional equipment that form a part of the anesthesia system (i.e. vaporizers, 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 5 A on the 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 place MPSOs on the floor.

WARNING:

Connect the anesthesia system to an AC power source before the internal battery 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.

Operator’s Manual of Anesthesia System

Safety

Safety Information

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

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 anesthesia system can be used with Halothane, 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. Otherwise, anesthetic agent vapor at a high concentration can get into the equipment 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 equipment.

WARNING:

Possible electric shock hazard. The equipment 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:

Set the alarm limits properly based on the patient conditions 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 equipment 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 equipment.

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 when the gas supply pressure is smaller than 200 kPa.

WARNING:

Standard gas terminal connectors tailored to the attributes of gases should be used on the gas supply hose assembly to avoid damage to people and materials from improper connectors used.

WARNING:

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

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Safety Information

1-4

Safety

•

Refer to the material safety data sheet as applicable.

•

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

•

Do not inhale fumes produced during any disinfection process.

WARNING:

Use extreme care while handling the CO2 absorbent as it is a caustic irritant.

WARNING:

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

WARNING:

Do not use talc, calcium stearate, corn starch or similar materials, 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 breathing tubes, face masks, sensors, soda lime, 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 the patient, do not perform test or maintenance when the equipment is in use.

WARNING:

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

WARNING:

The equipment should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment 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 equipment, it should only be moved by qualified personnel.

WARNING:

Overloading machine may cause tipping. Equipment attached to the side of the equipment should be within the rated weights to prevent dumping of the machine.

WARNING:

Excess load may cause a tip hazard while moving the equipment. Before moving, remove all equipment from the top shelf and all monitoring equipment installed to the side of the equipment. Use care when moving the equipment up or down a slope, around a corner, and across threshold. Do not attempt to roll the equipment over hoses, cords, or other obstacles.

WARNING:

Leaks or internal venting of sampled gas may affect accuracy. Perform proper preoperative tests to ensure that the equipment is operating properly. Leaky circuits can not be used.

WARNING:

Connecting the equipment's exhaust port to the hospital’s waste gas scavenging system is strongly recommended to prevent exposure of hospital personnel to the waste gas.

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Safety

Safety Information

WARNING:

Pins of connectors identified with the ESD warning symbol should not be touched. Connections should not be made to these connectors unless ESD precautionary procedures are used.

WARNING:

Operation of the equipment below the minimum flow values may cause inaccurate results.

WARNING:

This equipment/system is intended for use by healthcare professionals 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 equipment, or shielding the location it was placed.

WARNING:

Ensure that an independent means of ventilation (e.g. a self-inflating manual resuscitator with mask) is available whenever the equipment is in use.

WARNING:

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

WARNING:

Before using the anesthesia system after cleaning or disinfecting, power on the system and follow the on-screen prompts to perform leak test and compliance test. See (Pages 5-7) 5.4.2"Leak & Compliance Test".

WARNING:

If the equipment is damaged in any way that compromises the safety of the patient or user, discontinue use and attach a visible label indicating that the equipment is unusable. Please contact Mindray Technical Support.

WARNING:

Oxygen, when present in high concentrations, can significantly increase the chance of fire or explosion. Oil and grease may be ignited at the same time. Therefore, oil and grease 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. Please use lubricants as 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 or disassembling connectors should be performed only by qualified personnel.

WARNING:

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

WARNING:

Check the specifications of the Anesthetic Gas Scavenging System (AGSS) and the specifications of the anesthesia system to ensure compatibility and to prevent a mismatched processing 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.

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