Mindray EX 65 User manual

WATO EX-65 Anesthesia

Machine

Operator’s Manual

CE Marking

The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive.

The product is in radio-interference protection Group I Class B in accordance with EN55011.

The product complies with the requirement of standard EN60601-1-2 “Electromagnetic Compatibility – Medical Electrical Equipment”.

Revision History

This manual has a revision number. This revision number changes whenever the manual is updated due to software or technical specification change. Contents of this manual are subject to change without prior notice. Revision 1.0 is the initial release of the document.

	Revision number:	1.0
	Release time:	2009-1

© Copyright 2009 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

WARNING

zFederal Law (USA) restricts this device to sale by or on the order of a physician.

I

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights 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, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden

, and WATO are the registered trademarks or trademarks owned by

Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.

Contents of this manual are subject to changes without prior notice.

II

Manufacturer’s Responsibility

All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor 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; and

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.

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

Any Mindray product which has been subjected to misuse, negligence or accident; or

Any Mindray product from which Mindray's original serial number tag or product identification markings have been altered or removed; or

Any product of any other manufacturer.

III

Return Policy

In the event that it becomes necessary to return a unit to Mindray, follow the instructions below.

1.Return authorization.

Contact the Customer Service Department and obtain a Customer Service Authorization number. This number must appear on the outside of the shipping container. Returned shipments will not be accepted if the number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return.

2.Freight policy

The customer is responsible for freight charges when this product is shipped to Mindray for service (this includes customs charges).

3.Return address

Please send the part(s) or equipment to the address offered by the Customer Service Department.

Contact Information

Manufacturer:	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address:	Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,
	Nanshan, Shenzhen 518057 P.R. China
Tel:	[phone]	[phone]
Fax:	[phone]	[phone]
Website:	www.mindray.com
EC-Representative:	Shanghai International Holding Corp. GmbH (Europe)
Address:	Eiffestraße 80, Hamburg 20537, Germany
Tel:	0049-40-2513175
Fax:	0049-40-255726

IV

Preface

Manual Purpose

This manual 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 geared 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 machine.

Conventions

Italic text is used in this manual to quote the referenced chapters or sections.

[ ] is used to enclose screen texts.

→ is used to indicate operational procedures.

V

FOR YOUR NOTES

VI

Contents

1 Safety.................................................................................................................................		1-1
1.1	Safety Information ..........................................................................................................	1-1
	1.1.1 Dangers ..............................................................................................................	1-2
	1.1.2 Warnings.............................................................................................................	1-2
	1.1.3 Cautions .............................................................................................................	1-3
	1.1.4 Notes ..................................................................................................................	1-4
1.2	Equipment Symbols ........................................................................................................	1-5

2 The Basics .........................................................................................................................		2-1
2.1	System Description .........................................................................................................	2-1
	2.1.1 Intended Use.......................................................................................................	2-1
	2.1.2 Contraindications ...............................................................................................	2-1
	2.1.3 Components .......................................................................................................	2-2
2.2	Equipment Appearance ...................................................................................................	2-3
	2.2.1 Front View..........................................................................................................	2-3
	2.2.2 Rear View...........................................................................................................	2-7
2.3	Batteries ........................................................................................................................	2-12

3 System Controls and Basic Settings................................................................................		3-1
3.1	Display Control ...............................................................................................................	3-1
3.2	Display Screen ................................................................................................................	3-3
3.3	Basic Settings..................................................................................................................	3-5
	3.3.1 Adjust Screen Brightness ...................................................................................	3-5
	3.3.2 Adjust Sound Volume.........................................................................................	3-5
	3.3.3 Set System Time.................................................................................................	3-6
	3.3.4 Set Language......................................................................................................	3-6
	3.3.5 Set Unit ..............................................................................................................	3-6
	3.3.6 Restore Default Configurations..........................................................................	3-6
	3.3.7 Set the IP Address of Anesthesia Information System (CIS) .............................	3-7

4 Operations and Ventilation Setup...................................................................................		4-1
4.1	Turn on the System .........................................................................................................	4-1
4.2	Turn off the System.........................................................................................................	4-1
4.3	Input Fresh Gas ...............................................................................................................	4-2
	4.3.1 Set O2, N2O and Air Inputs .................................................................................	4-2
	4.3.2 Set Anesthetic Agent ..........................................................................................	4-3
4.4	Set Ventilation Mode.......................................................................................................	4-4
	4.4.1 Set Manual Ventilation Mode.............................................................................	4-4
	4.4.2 Make Settings before Starting Mechanical Ventilation Mode............................	4-5
	1

	4.4.3 Volume Control Ventilation (VCV)....................................................................	4-5
	4.4.4 Pressure Control Ventilation (PCV) ...................................................................	4-8
	4.4.5 Synchronized Intermittent Mandatory Ventilation (SIMV)...............................	4-11
	4.4.6 Pressure Support Ventilation (PSV) .................................................................	4-17
4.5	Start Mechanical Ventilation .........................................................................................	4-21
4.6	Set the Timer .................................................................................................................	4-22
	4.6.1 Start the Timer..................................................................................................	4-22
	4.6.2 Stop the Timer ..................................................................................................	4-22
	4.6.3 Reset the Timer ................................................................................................	4-22
4.7	Stop Mechanical Ventilation .........................................................................................	4-23
5 User Interface and Parameter Monitoring ....................................................................		5-1
5.1	Screen Layout .................................................................................................................	5-1
	5.1.1 Standby Screen...................................................................................................	5-2
	5.1.2 Normal Screen....................................................................................................	5-3
	5.1.3 Special Screen ....................................................................................................	5-4
5.2	Screen Setup....................................................................................................................	5-5
5.3	Parameter Monitoring .....................................................................................................	5-5
	5.3.1 O2 Concentration Monitoring ............................................................................	5-5
	5.3.2 Anesthetic Agent (AA) Concentration Monitoring ............................................	5-7
	5.3.3 CO2 Concentration Monitoring .........................................................................	5-8
	5.3.4 Pressure Monitoring ...........................................................................................	5-9
	5.3.5 Tidal Volume Monitoring .................................................................................	5-10
	5.3.6 Tidal Volume Compensation ............................................................................	5-12
	5.3.7 Volume Monitoring ..........................................................................................	5-13
	5.3.8 Breath Rate Monitoring....................................................................................	5-13
	5.3.9 BIS Monitoring ................................................................................................	5-14
5.4	Display Electronic Flowmeter.......................................................................................	5-16
5.5	Spirometry Loop ...........................................................................................................	5-16
6 Preoperative Test..............................................................................................................		6-1
6.1	Preoperative Test Schedules............................................................................................	6-1
	6.1.1 Test Intervals ......................................................................................................	6-1
6.2	Inspect the System ..........................................................................................................	6-2
6.3	Power Failure Alarm Test................................................................................................	6-2
6.4	Pipeline Tests ..................................................................................................................	6-3
	6.4.1 O2 Pipeline Test .................................................................................................	6-3
	6.4.2 N2O Pipeline Test ..............................................................................................	6-4
	6.4.3 Air Pipeline Test .................................................................................................	6-4
6.5	Cylinder Tests..................................................................................................................	6-4
	6.5.1 Check the Cylinder in Full Status.......................................................................	6-4
	6.5.2 O2 Cylinder High Pressure Leak Test................................................................	6-5
	6.5.3 N2O Cylinder High Pressure Leak Test .............................................................	6-5
6.6	Flow Control System Tests .............................................................................................	6-5
	2

	6.6.1 Without O2 Sensor .............................................................................................	6-5
	6.6.2 With O2 Sensor ..................................................................................................	6-7
6.7	Vaporizer Back Pressure Test ..........................................................................................	6-8
6.8	Breathing System Tests ...................................................................................................	6-9
	6.8.1 Bellows Test .......................................................................................................	6-9
	6.8.2 Breathing System Leak Test in Mechanical Ventilation Status ........................	6-10
	6.8.3 Breathing System Leak Test in Manual Ventilation Status................................	6-11
	6.8.4 APL Valve Test ..................................................................................................	6-11
6.9 Alarm Tests....................................................................................................................		6-12
	6.9.1 Prepare for Alarm Tests....................................................................................	6-12
	6.9.2 Test the O2 Concentration Monitoring and Alarms..........................................	6-13
	6.9.3 Test the Low Minute Volume Alarm ................................................................	6-13
	6.9.4 Test the Apnea Alarm .......................................................................................	6-14
	6.9.5 Test the Sustained Airway Pressure Alarm.......................................................	6-14
	6.9.6 Test the High Paw Alarm..................................................................................	6-14
	6.9.7 Test the Low Paw Alarm ..................................................................................	6-15
	6.9.8 Test the AG Module Alarm ..............................................................................	6-15
6.10 Preoperative Preparations............................................................................................		6-15
6.11 Inspect the AGSS ........................................................................................................		6-16
7 User Maintenance.............................................................................................................		7-1
7.1	Repair Policy...................................................................................................................	7-1
7.2	Maintenance Schedule ....................................................................................................	7-2
7.3	Breathing System Maintenance.......................................................................................	7-3
7.4	Flow Sensor Calibration..................................................................................................	7-3
7.5	O2 Sensor Calibration .....................................................................................................	7-5
	7.5.1 21% O2 Calibration............................................................................................	7-5
	7.5.2 100% O2 Calibration..........................................................................................	7-6
7.6	Water Build-up in the Flow Sensor .................................................................................	7-7
	7.6.1 Prevent Water Build-up ......................................................................................	7-7
	7.6.2 Clear Water Build-up..........................................................................................	7-8
7.7 Airway Pressure Gauge Zeroing .....................................................................................		7-8
7.8 AGSS Transfer Tube Maintenance................................................................................		7-10
8 CO2 Monitoring ...............................................................................................................		8-1
8.1	Introduction.....................................................................................................................	8-1
8.2	Identify CO2 Module ......................................................................................................	8-2
8.3	Use a Sidestream CO2 Module .......................................................................................	8-3
	8.3.1 Prepare to Measure CO2 ....................................................................................	8-3
	8.3.2 Make CO2 Settings ............................................................................................	8-4
	8.3.3 Measurement Limitations...................................................................................	8-6
	8.3.4 Troubleshooting..................................................................................................	8-6
	8.3.5 Scavenge the Sample Gas ..................................................................................	8-7
	8.3.6 Zero the Sensor ..................................................................................................	8-7
	3

		8.3.7 Calibrate the Sensor ...........................................................................................	8-7
8.4	Use a Microstream CO2 Module ....................................................................................		8-8
		8.4.1 Prepare to Measure CO2 ....................................................................................	8-8
		8.4.2 Make CO2 Settings ............................................................................................	8-8
		8.4.3 Measurement Limitations..................................................................................	8-11
		8.4.4 Scavenge the Sample Gas .................................................................................	8-11
		8.4.5 Zero the Sensor ................................................................................................	8-12
		8.4.6 Calibrate the Sensor .........................................................................................	8-12
		8.4.7 Oridion Information .........................................................................................	8-12
8.5	Use a Mainstream CO2 Module....................................................................................		8-13
		8.5.1 Prepare to Measure CO2 ..................................................................................	8-13
		8.5.2 Make CO2 Settings ..........................................................................................	8-14
		8.5.3 Measurement Limitations.................................................................................	8-16
		8.5.4 Zero the Sensor ................................................................................................	8-16
		8.5.5 Calibrate the Sensor .........................................................................................	8-16
9 AG and O2 Concentration Monitoring ..........................................................................			9-1
9.1	Introduction.....................................................................................................................		9-1
9.2	Understand MAC Values.................................................................................................		9-2
9.3	Identify AG Modules.......................................................................................................		9-3
9.4	Prepare to Measure AG ...................................................................................................		9-3
9.5	Make AG Settings ...........................................................................................................		9-5
		9.5.1 Set Anesthetic Agent ..........................................................................................	9-5
		9.5.2 Set Pump Rate....................................................................................................	9-5
		9.5.3 Set O2 Compensation.........................................................................................	9-5
		9.5.4 Set Working Mode..............................................................................................	9-5
		9.5.5 Set CO2 Unit......................................................................................................	9-6
		9.5.6 Restore Defaults.................................................................................................	9-6
		9.5.7 Set CO2 Waveform ............................................................................................	9-6
9.6	Change Anesthetic Agent ................................................................................................		9-6
9.7	Measurement Limitations................................................................................................		9-7
9.8 Troubleshooting ..............................................................................................................			9-7
9.9	Scavenge the Sample Gas ...............................................................................................		9-8
9.10		Calibrate the AG Module ..............................................................................................	9-8
10 BIS Monitoring.............................................................................................................			10-1
10.1		Introduction.................................................................................................................	10-1
10.2		Identify the BIS Module..............................................................................................	10-1
10.3		Safety Information ......................................................................................................	10-2
10.4		Understand BIS Parameters ........................................................................................	10-3
10.5		Prepare to Measure BIS ..............................................................................................	10-4
10.6		Continuous Impedance Check.....................................................................................	10-5
10.7		Cyclic Impedance Check.............................................................................................	10-6
10.8		BIS Sensor Check Window.........................................................................................	10-6
			4

10.9 Set BIS Smoothing Rate..............................................................................................	10-7
10.10 Restore Defaults........................................................................................................	10-7
10.11 Set BIS Related Waveforms ......................................................................................	10-8
11 Alarms ............................................................................................................................	11-1
11.1 Introduction ..................................................................................................................	11-1
11.1.1 Alarm Categories.............................................................................................	11-1
11.1.2 Alarm Levels ...................................................................................................	11-2
11.2 Alarm Indicators...........................................................................................................	11-2
11.2.1 Alarm Lamp.....................................................................................................	11-2
11.2.2 Audible Alarm Tones.......................................................................................	11-3
11.2.3 Alarm Message................................................................................................	11-3
11.2.4 Flashing Alarm Numeric .................................................................................	11-3
11.2.5 Alarm Status Symbols .....................................................................................	11-3
11.3 Set Alarm Volume ........................................................................................................	11-4
11.4 Set Alarm Limits ..........................................................................................................	11-4
11.4.1 Set Ventilator Alarm Limits.............................................................................	11-4
11.4.2 Set CO2 Alarm Limits.....................................................................................	11-4
11.4.3 Set AG Alarm Limits.......................................................................................	11-5
11.4.4 Set BIS Alarm Limits ......................................................................................	11-5
11.5 Set Alarm Level............................................................................................................	11-5
11.6 Set Cardiopulmonary Bypass (CPB) Alarm.................................................................	11-5
11.7 Set MV&TVe Alarm.....................................................................................................	11-6
11.8 Set Apnea Alarm...........................................................................................................	11-6
11.9 Alarm Silence ...............................................................................................................	11-7
11.9.1 Set 120 s Alarm Silence...................................................................................	11-7
11.9.2 Cancel 120 s Alarm Silence.............................................................................	11-7
11.10 When an Alarm Occurs ..............................................................................................	11-7
12 Trend and Logbook......................................................................................................	12-1
12.1 Trend Graph ................................................................................................................	12-1
12.2 Trend Table..................................................................................................................	12-2
12.3 Alarm Logbook ...........................................................................................................	12-3
13 Installations and Connections .....................................................................................	13-1
13.1 Install the Breathing System .......................................................................................	13-1
13.1.1 Breathing System Diagrams...........................................................................	13-2
13.1.2 Circuit Adapter Diagram ................................................................................	13-3
13.1.3 Install the Breathing system ...........................................................................	13-4
13.1.4 Install the Bag Arm ........................................................................................	13-6
13.1.5 Install the Bellows..........................................................................................	13-7
13.1.6 Install the Flow sensor....................................................................................	13-9
13.1.7 Install the O2 Sensor ....................................................................................	13-10
13.1.8 Install the Sodalime Canister........................................................................	13-12
5

13.2	Install the Breathing Tubes........................................................................................	13-19
13.3	Install the Manual Bag ..............................................................................................	13-20
13.4	Install the Vaporizer ..................................................................................................	13-21
	13.4.1 Assemble the Vaporizer................................................................................	13-21
	13.4.2 Fill the Vaporizer..........................................................................................	13-25
	13.4.3 Drain the Vaporizer ......................................................................................	13-27
13.5	Install/Replace the Gas Cylinder...............................................................................	13-29
13.6	Install Modules..........................................................................................................	13-31
	13.6.1 Install the CO2 Module................................................................................	13-31
	13.6.2 Install the AG Module..................................................................................	13-31
	13.6.3 Install the BIS Module .................................................................................	13-32
13.7	Pneumatic Connectors...............................................................................................	13-32
	13.7.1 Connect the Pipeline Gas Supplies...............................................................	13-33
	13.7.2 Install the Gas Cylinder................................................................................	13-34
13.8	CIS Connector...........................................................................................................	13-34
13.9	Scavenging ................................................................................................................	13-34
13.10 AGSS Transfer and Receiving System....................................................................		13-35
	13.10.1 Components................................................................................................	13-35
	13.10.2 Assemble the AGSS ...................................................................................	13-36
	13.10.3 Waste Gas Disposal System .......................................................................	13-37
14 Cleaning and Disinfection............................................................................................		14-1
14.1	Clean and Disinfect the Anesthesia Machine Housing................................................	14-2
14.2	Disassemble the Breathing System Cleanable Parts ...................................................	14-2
	14.2.1 O2 Sensor.......................................................................................................	14-3
	14.2.2 Manual Bag ....................................................................................................	14-4
	14.2.3 Breathing Tubes .............................................................................................	14-5
	14.2.4 Airway Pressure Gauge ..................................................................................	14-6
	14.2.5 Bag Arm .........................................................................................................	14-6
	14.2.6 Bellows Assembly..........................................................................................	14-7
	14.2.7 Flow Sensor....................................................................................................	14-8
	14.2.8 Expiratory Check Valve Assembly.................................................................	14-9
	14.2.9 Inspiratory Check Valve Assembly ................................................................	14-9
	14.2.10 Sodalime Canister ......................................................................................	14-10
	14.2.11 Water Collection Cup ..................................................................................	14-11
	14.2.12 Breathing system........................................................................................	14-12
	14.2.13 AGSS Transfer and Receiving System.......................................................	14-13
14.3	Clean&Disinfect and Re-install the Breathing System .............................................	14-15
	14.3.1 Breathing system..........................................................................................	14-17
	14.3.2 Water Collection Cup ...................................................................................	14-17
	14.3.3 Manual Bag ..................................................................................................	14-17
	14.3.4 Breathing Mask ............................................................................................	14-18
	14.3.5 Inspiratory and Expiratory Check Valves Assembly ....................................	14-18
	14.3.6 Bellows Assembly........................................................................................	14-18
	6

	14.3.7 Sodalime Canister ........................................................................................	14-19
	14.3.8 Breathing Tubes and Y Piece........................................................................	14-20
	14.3.9 Flow Sensor..................................................................................................	14-20
	14.3.10 O2 Sensor...................................................................................................	14-21
	14.3.11 AGSS Transfer and Receiving System .......................................................	14-21
15 Accessories ....................................................................................................................		15-1
A Theory of Operation.......................................................................................................		A-1
A.1 Pneumatic Circuit System .............................................................................................		A-1
A.2 Electrical System Structure ...........................................................................................		A-4
B Product Specifications.....................................................................................................		B-1
B.1	Safety Specifications ......................................................................................................	B-1
B.2	Environmental Specifications.........................................................................................	B-2
B.3	Power Requirements.......................................................................................................	B-2
B.4	Physical Specifications...................................................................................................	B-3
B.5	Pneumatic Circuit System Specifications.......................................................................	B-4
B.6	Breathing System Specifications....................................................................................	B-5
B.7	Ventilator Specifications.................................................................................................	B-7
B.8	Ventilator Accuracy ........................................................................................................	B-9
B.9 Anesthetic vaporizer .....................................................................................................		B-10
B.10 AGSS Transfer and Receiving System Specifications................................................		B-10
B.11 O2 Sensor Specifications............................................................................................		B-11
B.12 CO2 Module Specifications .......................................................................................		B-14
B.13 AG Module Specifications .........................................................................................		B-17
B.14 BIS Module Specifications.........................................................................................		B-21
C EMC ................................................................................................................................		C-1
D Alarm Messages..............................................................................................................		D-1
D.1 Physiological Alarm Messages......................................................................................		D-1
D.2 Technical Alarm Messages............................................................................................		D-4
E Symbols and Abbreviations ............................................................................................		E-1
E.1 Symbols ..........................................................................................................................		E-1
E.2 Abbreviations..................................................................................................................		E-3
F Factory Defaults...............................................................................................................		F-1
F.1 CO2 Module....................................................................................................................		F-1
F.2 AG Module......................................................................................................................		F-2
F.3 BIS Module .....................................................................................................................		F-3
F.4 Ventilator .........................................................................................................................		F-4

7

FOR YOUR NOTES

8

1 Safety

1.1 Safety Information

DANGER

zIndicates an imminent hazard that, if not avoided, will result in death or serious injury.

WARNING

zIndicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury.

CAUTION

zIndicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.

NOTE

zProvides application tips or other useful information to ensure that you get the most from your product.

1-1

1.1.1 Dangers

There are no dangers that refer to the product in general. Specific “Danger” statements may be given in the respective sections of this manual.

1.1.2 Warnings

WARNING

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

zThe 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.

zUse AC power source before the batteries are depleted.

zTo avoid explosion hazard, do not use the equipment in the presence of flammable anesthetic agent, vapors or liquids.

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

zDo not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level may result in a hazard to the patient. Remember that alarm settings should be customized according to different patient situations and always keeping the patient under close surveillance is the most reliable way for safe patient monitoring.

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

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

zTo avoid explosion hazard, do not use flammable anesthetic agent such as ether and cyclopropane for this equipment. Only non-flammable anesthetic agents which meet the requirements specified in IEC 60601-2-13 can be applied to this equipment. This anesthesia machine can be used with halothane, enflurane, isoflurane, sevoflurane and desflurane. Only one of the five anesthetic agents can be used at a time.

zDo not touch the patient, table, or instruments during defibrillation.

1-2

WARNING

zUse appropriate electrodes and place them according to the instructions provided by the manufacturer. The display restores to normal within 10 seconds after defibrillation.

1.1.3 Cautions

CAUTION

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

zAt 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.

zMagnetic and electrical fields are capable of interfering with the proper performance of the equipment. For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements. Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.

zThis system operates correctly at the electrical interference levels identified in this manual. Higher levels can cause nuisance alarms that may stop mechanical ventilation. Pay attention to false alarms caused by high-intensity electrical fields.

zBefore connecting the equipment to the power line, check that the voltage and frequency ratings of the power line are the same as tube indicated on the equipment’s label or in this manual.

zAlways install or carry the equipment properly to avoid damage caused by drop, impact, strong vibration or other mechanical force.

zThe anesthesia machine keeps stable with a 10º tilt in typical configuration. Do not hang articles on both sides of the anesthesia machine for fear of getting tilted.

1-3

1.1.4 Notes

NOTE

zPut the equipment in a location where you can easily see the screen and access the operating controls.

zKeep this manual close to the equipment so that it can be obtained conveniently when needed.

zThe software was developed in compliance with IEC 60601-1-4. The possibility of hazards arising from software errors is minimized.

zThis manual describes all features and options. Your equipment may not have all of them.

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1.2 Equipment Symbols

				Attention: Consult
				accompanying documents (this		Dangerous voltage
				manual)
				Alternating current		Fuse
				Battery		Equipotential
				Operating state		Autoclavable
				Material description		Not autoclavable
				Power On		Power Off
				Reset		Standby
				Alarm silence key		MV&TVe alarm key
				Normal screen key		O2 flush button
				ACGO On		ACGO Off
				Bag position/ manual		Mechanical ventilation
				ventilation
				Lock		Unlock
				Network connector		Flow control
				USB connector		O2 sensor connector
				Air supply connector		N2O supply connector
				Upward (Pop-off valve)		Sample gas return port
						(to the AGSS)
	1-5

VGA connector		O2 supply connector
Table top light		AGSS outlet
Cylinder		PEEP outlet
Manufacture date		Vaporizer
Manufacturer		Isolation transformer
Serial number		European community
		representative
APL valve		CAUTION HOT
Maximum level of the		Lock or unlock as the
sodalime canister		arrow shows
Gas input direction		Unlock the lifting device
Lock the lifting device		Do Not Crush
Approximate		Please align!
Max. weight: 11.3 kg		Pipeline
Max. weight: 30 kg		CE marking
Type BF applied part.		The anesthesia machine
Defibrillation-proof protection
		is driven by Air.
against electric shock.

The following definition of the WEEE label applies to EU member states only. This symbol indicates that this product should not be treated as household waste. By ensuring that this product is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health. For more detailed information with regard to returning and recycling this product, please consult the distributor from whom you purchased it.

* For system products, this label may be attached to the main unit only.

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2 The Basics

2.1 System Description

2.1.1 Intended Use

The anesthesia machine is intended to provide breathing anesthesia for adult, pediatric and infant patients during surgery.

The anesthesia machine must only be operated by qualified anesthesia personnel who have received adequate training in its use.

WARNING

zThis anesthesia machine is intended for use by qualified anesthesia personnel only or under their guidance. Anyone unauthorized or untrained must not perform any operation on it.

zThis anesthesia machine is not suitable for use in an MRI environment.

2.1.2 Contraindications

The anesthesia machine is contraindicated for use on patients who suffer pneumothorax or severe pulmonary incompetence.

2-1

2.1.3 Components

The anesthesia machine consists of a main unit, vaporizer (five optional anesthetic agents: enflurane, isoflurane, sevoflurane, desflurane and halothane), anesthetic ventilator, electronic flowmeter assembly, breathing system etc.

The anesthesia machine provides monitoring and displaying of respiratory mechanics (RM) parameters (airway resistance and compliance) and spirometry loops as well. It is configured with the following ventilation modes: volume control ventilation (VCV), pressure control ventilation (PCV), pressure support ventilation (PSV), synchronized intermittent mandatory ventilation—volume control (SIMV-VC) and synchronized intermittent mandatory ventilation—pressure control (SIMV-PC).

The anesthesia machine can be externally connected to a patient monitor which is in compliance with the requirements of relevant international standard and can be configured with anesthesia information system (CIS).

The anesthesia machine features the following:

Automatic leak detection

Breathing system gas leak compensation and automatic compliance compensation

Cylinder and pipeline connections available for gas supplies

Electronic flowmeter and electronic PEEP

Timer which counts the duration between the start and end of an operation

Table top light

Information displayed in big numerics

User-adjustable display screen

Alarm events storage and review, fault status and maintenance information recording

Auxiliary O2 supply and active anesthesia gas scavenging system (AGSS)

N2O cut-off

Modular AG, CO2 and BIS modules

Sample gas return to the AGSS

Setting CPB alarm mode

2-2

2.2 Equipment Appearance

2.2.1 Front View

——Display and control panel

2-3

1.Brake

2.Pipeline pressure gauge (s)

Displays the pipeline pressure or the cylinder pressure after relief.

3.Total flowmeter

The medium level of flowtube float indicates the current flow of the mixed gas.

4Flow control (s)

When the system switch is set to the ON position:

Turn the control counterclockwise to increase the gas flow.

Turn the control clockwise to decrease the gas flow.

5Electronic flowmeter

Displays the current flow of the corresponding gas.

6.Ventilator control panel

7.Control knob

8.Display

9.Vaporizer

A.Concentration control

Push and turn the concentration control to set the concentration of anesthetic agent.

B.Locking lever

Turn the locking lever clockwise to lock the vaporizer in position.

10.Gas supply connector (s)

O2 , N2O and AIR connectors are provided.

11.System switch

Set the switch to the position to enable gas flow and to turn on the system.

Set the switch to the position to disable gas flow and to turn off the system.

12.Cylinder pressure gauge (s)

High-pressure pressure gauge (s) that displays cylinder pressure before relief.

13.O2 flush button

Push to supply high flows of O2 to the breathing system.

14.Auxiliary electrical outlet

Three auxiliary electrical outlets are provided when the anesthesia machine is configured with an isolation transformer.

15 Drawer lock

16. Worktable (with drawer)

2-4

——Breathing system

2-5

1.O2 sensor connector

2.Inspiration connector

3.Expiration connector

4.Inspiratory check valve

5.Expiratory check valve

6.Bellows housing

7.Sample gas return port (to the AGSS)

8.Manual bag port

9.Bag/mechanical ventilation switch

Select the position to use bag for manual ventilation.

Select the position to use ventilator for mechanical ventilation.

10.APL (airway pressure limit) valve

Adjusts breathing system pressure limit during manual ventilation. The scale shows approximate pressures. Above 30 cmH2O, you will feel clicks as the v turns. Turn clockwise to increase.

11.O2 sensor connector

12.Rotary handle

13.Sodalime canister

The sodalime inside the canister absorbs the CO2 the patient exhales, which enables cyclic use of the patient exhaled gas.

2-6

2.2.2 Rear View

——Power supply

2-7

1.Cylinder connector (s)

2.Equipotential stud

3.Fan

4.Mains inlet

5.Network connector

6.CIS 12 V power supply connector

7.Speaker

8.Auxiliary O2 supply

9.ACGO (Auxiliary Common Gas Outlet) switch

Set the switch to the position to stop mechanical ventilation. Then, fresh gas is sent to the externally connected manual breathing system through the ACGO outlet and the technical alarm of [ACGO On] is triggered. The system monitors airway pressure and O2 concentration instead of volume.

Set the switch to theposition to apply mechanical or manual ventilation to the patient through the breathing system.

10.Module slot

CO2, AG and BIS modules mentioned in this manual can be inserted into the slot and identified. The CO2 and AG modules cannot be used simultaneously.

11.AGSS outlet

12.AGSS Transfer and Receiving System

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