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Общая диагностика, Акушерство и гинекология, Ветеринария

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.

© 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

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

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.

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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.

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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

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.

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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

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2.2 Equipment Appearance

2.2.1 Front View

——Display and control panel

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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)

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——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.

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2.2.2 Rear View

——Power supply

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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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——Anesthesia information system (CIS)

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This rear view is based on the situation that the anesthesia machine is configured with anesthesia information system (CIS).

1.Display

2.Rail

3.Mounting bracket

4.Keyboard

5.CIS main unit

A

B

C

F E D C

A.Reset key

: Press to restart the CIS.

B.CIS switch

: Press to switch on/off the CIS.

C.USB connector

D.Network connector

E.Electrical outlet

F.Display connector

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WARNING

zConnect to the AC mains in compliance with B.3 Power Requirements. Failure to do so may cause damage to the equipment or affect its normal operation.

zMake sure that the jacket on the electrical outlet is already fixed to avoid power cord off during surgery.

NOTE

zIf the equipment cannot be powered by the AC mains, check if the fuse inside the electrical outlet is normal. If AC mains supply still fails after the fuse is replaced, contact the service personnel.

zWhen the auxiliary electrical outlet does not work normally, check if the corresponding fuse is burned.

zEquipment connected to the auxiliary electrical outlet shall be authorized. Otherwise, leakage current above the allowable limit will result, which may endanger the patient or operator, and damage the anesthesia machine or externally connected equipment. When the anesthesia machine is configured with only one auxiliary electrical outlet, this electrical outlet is only used for connecting the adapter for Desflurane vaporizer. When the anesthesia machine is configured with multiple auxiliary electrical outlets, the equipment connected shall comply with the voltage and current specifications of the auxiliary electrical outlets.

zAll 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 60601-1-1. The personnel who are responsible for connecting the optional equipment to the I/O signal port shall be responsible for medical system configuration and system compliance with IEC 60601-1-1 as well.

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2.3 Batteries

NOTE

zUse batteries at least once every month to extend their life. Charge the batteries before their capacities are worn out.

zInspect and replace batteries regularly. Battery life depends on how frequent and how long it is used. For a properly maintained and stored lithium battery, its life expectancy is approximately 3 years. For more aggressive use models, life expectancy can be shortened. We recommend replacing lithium batteries every 3 years.

zThe operating time of a battery depends on equipment configuration and operation. For example, starting module monitoring frequently will shorten the operating time of the batteries.

zIn case of battery failure, contact us or have your service personnel replace it. Do not replace the battery without permission.

The anesthesia machine is designed to operate on battery power whenever AC power becomes interrupted. When the anesthesia machine is connected to the AC power source, the batteries are charged regardless of whether or not the anesthesia machine is currently on. In case of power failure, the anesthesia machine will automatically be powered by the internal batteries. When AC power source is restored within the specified time, power supply is switched from battery to AC automatically to ensure continuous system use.

On-screen battery icon indicates the battery statuses as follows:

: indicates that the batteries operate normally. The solid portion represents the current charge level of the batteries in proportion to its maximum charge level.

: indicates low battery and the batteries need to be charged.

: indicates too low battery and the batteries need to be charged immediately.

The capacity of the internal battery is limited. If the battery capacity is too low, a high-level alarm will be triggered and the [Low Battery Voltage!] message displayed in the technical alarm area. In this case, apply AC power to the anesthesia machine.

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3 System Controls and Basic Settings

3.1 Display Control

1.Alarm lamp

High level alarms: the lamp quickly flashes red.

Medium level alarms: the lamp slowly flashes yellow.

Low level alarms: the lamp turns yellow without flashing.

2.Menu shortcut key(s)

Push the menu shortcut key to access the corresponding menu.

3.Control knob

Push the control knob to select a menu option or confirm your setting. Turn the control knob clockwise or counterclockwise to scroll through the menu options or change your settings.

3-1

4.MV&TVe alarm key

In case of manual ventilation mode: Push the key to switch off MV and TVe overrange alarms and apnea alarm. Push the key again to switch on MV and TVe overrange alarms and apnea alarm.

In case of mechanical ventilation mode: Push the key to switch off MV and TVe overrange alarms. Push the key again to switch on MV and TVe overrange alarms.

5.Normal screen key

Push the key to close all menus displayed.

6.Standby key

Push the key to enter or exit standby mode.

7.Alarm silence key

To set alarm silence state, push this key to enter 120 s alarm silenced status. The alarm silence symbol and 120 s countdown time appear in the upper right corner of the screen.

To clear alarm silence, push this key again.

8.Operating state LED

On: when the anesthesia machine is operating.

Off: when the anesthesia machine is turned off.

9.AC power LED

On: when the anesthesia machine is connected to the AC power source.

Off: when the anesthesia machine is not connected to the AC power source.

10.Battery LED

On: when the anesthesia machine is equipped with batteries and is connected to the AC power source, and the batteries are being charged.

Off: when the anesthesia machine is not equipped with batteries or is switched off.

Flash: when the anesthesia machine is being battery powered.

11.Ventilator parameter setup shortcut key(s)

Push the parameter setup shortcut key to change the corresponding setting. Turn the control knob to change the specific setting and push the control knob to activate the selected setting.

12.Display screen

Refer to 3.2Display Screen for details.

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3.2 Display Screen

This anesthesia machine adopts a high-resolution color TFT LCD to display various parameters and graphs, such as ventilation parameters and pressure/flow/volume waveforms. Depending on how your anesthesia machine is configured, it may display gas module parameters and waveforms, BIS parameters, BIS trend waveform, spirometry loops etc.The following is a standard display screen. For descriptions of other screens, refer to5 User Interface and Parameter Monitoring.

10

11

12

18

13

14

15

17

16

1.Ventilation mode prompt area

Displays the current ventilation mode. If manual ventilation is selected for the bag/mechanical ventilation switch, is displayed in this area. If mechanical

ventilation is selected for the bag/mechanical ventilation switch, the currently selected mechanical ventilation mode is displayed.

2.Lung icon area

The icon is displayed when SIMV-VC or SIMV-PC mode is selected and inspiration triggering is performed currently.

3.MV&TVe alarm off icon

Displays the MV&TVe alarm off icon when MV&TVe alarm is switched off.

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4.Physiological alarm area

Displays physiological alarm messages.

5.Apnea alarm off icon area

Displays apnea alarm off icon when apnea alarm is switched off in non-mechanical ventilation mode.

6.Alarm silence icon area

Displays alarm silence icon and 120 s countdown time.

7.System time area

Displays system time of the anesthesia machine.

8.Technical alarm area

Displays technical alarm messages. When multiple alarms occur, they are displayed cyclically.

9.Power supply state icon area

Displays power source or battery icon.The icon is displayed when the anesthesia machine is powered by AC power source. The battery icon is displayed when the anesthesia machine is battery powered to indicate battery capacity. For details, refer to2.3 Batteries.

10. [Vent Mode] shortcut key Used to select mechanical ventilation mode.

11.[Alarm Setup] shortcut key

Used to change the alarm settings for the anesthetic ventilator, gas modules or BIS module.

12.[Screens] shortcut key Used to set user screen.

13.[User Setup] shortcut key

Used to change the settings for TV compensation, O2 monitoring source, gas module, BIS module, screen, sound etc.

14.[Maintenance] shortcut key

Used to perform leak test, calibrate O2 sensor and flow sensor, view trend graph, trend table and alarm logbook, and set language, system time, pressure unit, IP address etc.

15.Timer setup shortcut key

Used to start, stop and reset the timer.

16.Parameter setup shortcut keys area

Used to set the parameters related to the selected mechanical ventilation mode. The arrangement of the shortcut keys in this area varies depending on the selected mechanical ventilation mode. For details, refer to 4 Operations and Ventilation Setup.

17 System prompt message area

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Displays information about system operating state.

18Parameter&graph area

Displays the parameters, waveforms, spirometry loops, or electronic flowmeter graphs which the anesthesia ventilator, gas module or BIS module monitors. Different types of screens are displayed based on the actual system configuration or screen layout settings. For details, refer to 5 User Interface and Parameter Monitoring.

3.3Basic Settings

This chapter covers only general settings of the anesthesia machine, such as language, screen brightness, system time etc. Parameter settings and other settings can be referred to in the respective sections.

3.3.1 Adjust Screen Brightness

1.Select the [User Setup] shortcut key and select [Screen and Audio Setup >>].

2.Select [Screen Brightness] and select the appropriate value (ranging from 1 to 10) for screen brightness. The value 10 is for the brightest and 1 the least bright. If the anesthesia machine is battery powered, you can select less brightness to save battery capacity.

3.3.2 Adjust Sound Volume

3.3.2.1 Key Sound Volume

1. Select the [User Setup] shortcut key and select [Screen and Audio Setup >>].

2. Select [Key Sound Volume] and select the appropriate value (ranging from 0 to 10) for key sound volume. The value 0 is for audio off and 10 for the loudest.

3.3.2.2 Alarm Sound Volume

1.Select the [User Setup] shortcut key and select [Screen and Audio Setup >>].

2.Select [Alarm Sound Volume] and select the appropriate value (ranging from 1 to 10) for alarm sound volume. The value 1 is for the lowest and 10 for the loudest.

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3.3.3 Set System Time

1.Select the [Maintenance] shortcut key → [User Maintenance >>] → [Set System Time >>].

2.Set [Date] and [Time].

3.Select [Date Format] and toggle between [YYYY-MM-DD], [MM-DD-YYYY] and [DD-MM-YYYY].

4.Select [Time Format] and toggle between [24 h] and [12 h].

CAUTION

zChanging date and time will affect the storage of trends and log information. It may also cause loss of data.

3.3.4 Set Language

1. Select the [Maintenance] shortcut key and select [User Maintenance >>]. 2. Select [Language] and select the desired language.

3. Restart the anesthesia machine to activate the language setting.

3.3.5 Set Unit

1.Select the [Maintenance] shortcut key and select [User Maintenance >>].

2.Select [Paw Unit] and toggle between cmH2O, hPa and mbar.

If the anesthesia machine is configured with CO2 or AG module, you can set the display units of FiCO2 and EtCO2. For details, refer to 8 CO2 Monitoring.

3.3.6 Restore Default Configurations

3.3.6.1 Restore the Factory Default Configuration of the Ventilator

To restore the factory default configuration of the ventilator, do as follows:

1.Select the [Maintenance] shortcut key → [User Maintenance >>] → [Ventilator Defaults].

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2.Select [Ok] from the pop-up menu.

After [Ok] is selected, the following settings restore their default values:

User screen

Ventilator parameters

Alarm limits of ventilator-related parameters

O2 monitoring source

Alarm sound volume and key sound volume

Screen brightness

Paw display unit

3.3.6.2 Restore the Factory Default Configuration of the Gas Module

If the anesthesia machine is configured with CO2 or AG module, you can directly restore the factory default configuration of the corresponding module. For details, refer to 8 CO2 Monitoring and 9 AG and O2 Concentration Monitoring.

3.3.6.3 Restore the Factory Default Configuration of the BIS Module

If the anesthesia machine is configured with BIS module, you can directly restore the factory default configuration of the corresponding module. For details, refer to 10 BIS Monitoring.

3.3.7 Set the IP Address of Anesthesia Information System

(CIS)

To set the IP address of anesthesia information system (CIS), do as follows:

1.Select the [Maintenance] shortcut key → [User Maintenance >>] → [Set IP Address >>].

2.In the [Set IP Address] menu, set the correct IP address of the CIS.

3.Select [Ok] to activate the IP address setting.

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FOR YOUR NOTES

3-8

4 Operations and Ventilation Setup

WARNING

zBefore using this anesthesia machine on the patient, make sure that the system is correctly connected and in good condition, and that all the tests described in 6 Preoperative Test are already completed. In case of test failure, do not use the system. Have a qualified service representative repair the system.

4.1Turn on the System

1.Connect the power cord to the AC power source. Make sure that the AC power LED is illuminated.

2.Set the system switch to ON. Make sure that both the operating state LED and battery LED are illuminated (the battery is being charged or fully charged).

3.The alarm lamp flashes yellow and red once in turn and then a beep is given.

4.The display shows the start-up screen and then enters the standby screen after half a minute.

WARNING

zDo not use the anesthesia machine if it generates alarms during start-up or fails to operate normally. Contact your service personnel or us.

4.2Turn off the System

To turn off the system, do as follows:

1.Confirm that system use is finished.

2.Set the system switch to OFF.

NOTE

zFor the first mechanical ventilation of each patient, do not exit the standby screen if mechanical ventilation related parameters are not set properly. Adjust fresh gas and anesthetic agent concentrations (if necessary) on the standby screen and set ventilation parameters properly based on the patient’s conditions before applying mechanical ventilation.

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4.3 Input Fresh Gas

4.3.1 Set O2, N2O and Air Inputs

1.Connect the gas supplies correctly and ensure adequate gas pressure.

2.You can control the O2, N2O and Air flows in the fresh gas through the O2, N2O and Air flow controls. Readings of the gas flow can be seen on the respective electronic flowmeter. On the left hand of the electronic flowmeters is the total flowmeter showing the flow of the mixed gas.

The O2 and N2O flow controls constitute a chain linkage:

Turn the N2O flow control counterclockwise to increase the N2O flow to some extent. Then continuing turning the N2O flow control will cause the O2 flow control to turn counterclockwise together to increase the O2 flow, keeping the O2 concentration in the mixed gas above 25%.

Turn the O2 flow control clockwise to decrease the O2 flow to some extent. Then continuing turning the O2 flow control will cause the N2O flow control to turn clockwise together to decrease the N2O flow, keeping the O2 concentration in the mixed gas above 25%.

NOTE

zThis anesthesia machine can be used alone as a ventilator. You can adjust O2 concentration in the breathing system through the O2 flow control.

zThe O2 concentration in the fresh gas may be quite different from that in the breathing system.

zThe total flowmeter is calibrated based on 100% O2. The accuracy of the flowmeter may degrade with other gas or mixed gas.

zWhen viewing the readings on the total flowmeter, keep your visual angle at the same level of the float. The reading of a same scale may vary when viewed at a different angle.

zIf the readings shown on the electronic flowmeters differ from that on the total flowmeter, the former shall prevail and the latter is an approximate value.

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4.3.2 Set Anesthetic Agent

NOTE

zYou do not need to perform this operation if inspiratory anesthetic agent is not used.

zThis anesthesia machine can be mounted with vaporizers corresponding with halothane, enflurane, isoflurane, sevoflurane and desflurane. Only one of the five vaporizers can be opened at a time because the vaporizers are featured with interlock.

4.3.2.1 Select the Desired Anesthetic Agent

1.Determine the anesthetic agent to be used and then fill the vaporizer. For details, refer to

13.4.2 Fill the Vaporizer.

2.Mount the vaporizer filled with anesthetic agent onto the anesthesia machine. For details, refer to 13.4 Install the Vaporizer.

4.3.2.2 Adjust the Concentration of Anesthetic Agent

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

NOTE

zInspect the color of the sodalime in the canister before using the anesthetic agent. Replace the sodalime immediately if obvious color change is detected.

zFor details about how to use the anesthetic agent, refer to the Vaporizer Instructions for Use.

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4.4 Set Ventilation Mode

4.4.1 Set Manual Ventilation Mode

1.Turn the APL valve control to adjust the pressure in the breathing system within the appropriate range.

2.Set the bag/mechanical ventilation switch to the position. The ventilation mode

prompt area displays the icon for manual ventilation mode. Besides, the system prompt message area displays [Manual Vent.].

3.Push the O2 flush button to inflate the bag if necessary.

In the manual ventilation mode, you can use the APL valve to adjust the breathing system pressure limit and gas volume in the manual bag. When the pressure in the breathing system reaches the pressure limit set for the APL valve, the valve opens to release excess gas.

The following figures show the Paw waveform and flow waveform in the manual ventilation

mode.

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NOTE

zWhen using the anesthesia machine on the patient, make sure that manual ventilation mode is available.

4.4.2 Make Settings before Starting Mechanical Ventilation

Mode

1.Make sure that the system is Standby.

2.Set the appropriate Plimit value in the parameter setup shortcut keys area.

3.Check the ACGO switch to make sure that it is OFF.

4.Set the bag/mechanical ventilation switch to the position.

5.If necessary, push the O2 flush button to inflate the bellows.

NOTE

zThe default mechanical ventilation mode of the anesthesia machine is VCV. Other mechanical ventilation modes are optional. For the ventilation mode not configured for your anesthesia machine, operations of the corresponding menu options are disabled.

4.4.3 Volume Control Ventilation (VCV)

4.4.3.1 Description

Volume control ventilation (hereinafter referred to as VCV) mode is a basic fully-mechanical ventilation mode. In the VCV mode, each time mechanical ventilation starts, gas is delivered to the patient at a constant flow, which reaches the preset TV within the gas delivery time. To ensure a certain amount of TV, the resulted airway pressure (Paw) changes based on patient pulmonary compliance and airway resistance. In the VCV mode, as long as Paw is less than Plimit and the gas delivery flow is kept constant, expirations starts immediately after Plimit is reached.

In the VCV mode, you need to set [Plimit] to prevent high airway pressure from injuring the patient. In this mode, you can select to set [TIP :TI] to improve patient pulmonary gas distribution and [PEEP] to improve expiration of end-tidal carbon dioxide and to increase oxygenation of breathing process.

4-5

To ensure the set tidal volume gas delivery, the ventilator adjusts gas flow based on the measured inspiratory volume, dynamically compensates for the loss of tidal volume arising from breathing system compliance and system leakage and eliminates the effect of fresh gas as well. This is called tidal volume compensation.

In the VCV mode, if tidal volume compensation is turned off or failed, the anesthesia machine can continue delivering gas stably but cannot compensate for the effects of fresh gas flow and breathing system compliance losses.

4.4.3.2 Waveforms

The following figures show the Paw waveform and flow waveform in the VCV mode.

Generally, in the VCV mode, the flow waveform is at a constant flow during inspiration and the Paw waveform rises in the same period.

4.4.3.3 Start VCV Mode

1.Select the [Vent Mode] shortcut key to open the [Vent Mode Setup] menu.

2.Select [VCV] in the [Vent Mode Setup] menu.

3.After confirming the selection, the[TV] shortcut key (the first key from the left in the parameter setup shortcut keys area) is highlighted.

4.Make sure that TV is appropriately set for the patient. Push the control knob to confirm the setting so as to start VCV mode.

4-6

NOTE

zWhen it is necessary to switch over to VCV mode, confirm the setting of TV first. Otherwise, the system works in the previous ventilation mode. If the setting of TV is not confirmed for 10 s, the screen returns to the previous mode automatically.

zBefore activating a new mechanical ventilation mode, make sure that all related parameters are set appropriately.

4.4.3.4 Parameter Setup Shortcut Keys Area in VCV Mode

When selection of VCV mode is confirmed, the parameter setup shortcut keys area at the bottom of the screen is automatically switched over to the parameter setup area in this mode. The following figure shows all related parameters to be set in VCV mode.

4.4.3.5 Set Parameters in VCV Mode

You can use the shortcut keys and control knob to set the parameters in VCV mode. The following takes setting of TV as an example.

1.Select the [TV] shortcut key.

2.Push the control knob and turn it to set [TV] to the appropriate value.

3.Push the control knob to confirm the setting.

4.Set other parameters in this mode in the similar way.

4-7

NOTE

zIf the parameter value is adjusted outside of the range, the system prompt message area displays [Parameter Settings Outside the Safety Range].

zConfirm the adjustment of one parameter before adjusting another parameter. If you want to restore the value before adjustment, you have to reset the parameter value.

4.4.3.6 Parameter Range and Default Value in VCV Mode

4.4.4 Pressure Control Ventilation (PCV)

4.4.4.1 Description

Pressure control ventilation (hereinafter referred to as PCV) mode is a basic fully-mechanical ventilation mode. In the PCV mode, each time mechanical ventilation starts, Paw rises rapidly to the preset Plimit. Then gas flow slows down through the feedback system to keep Paw constant until expiration starts at the end of inspiration. The tidal volume delivered in the PCV mode changes based on patient pulmonary compliance and airway resistance.

In the PCV mode, you need to set Plimit to prevent high airway pressure from injuring the patient.

In the PCV mode, you can also select to set [PEEP] to improve expiration of end-tidal carbon dioxide and to increase oxygenation of breathing process.

4-8

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