User Manual AX 400.AX 500

Copyright
Edition: C
No.:046-000561-02
Date:03/2018
Shenzhen Comen Medical Instruments Co., Ltd.
Product Information
Product Name: Anesthesia Machine
Models: AX‐400, AX‐500
Software Version: V4
CE information：
Address: No.2 of FIYTA Timepiece Building, Nanhuan Avenue, Gongming sub‐district, Guangming New
District, Shenzhen, 518106, Guangdong, China.
Statement
Shenzhen Comen Medical Instruments Co., Ltd. (hereinafter referred to as Comen or Comen
Company)owns the copyright of this User’s Manual (non‐public publication), and has a right to process
it as restricted materials. This User’s Manual may serve as references for operation, maintenance and
repair of Comen products. Anybody else has no right to show to people the contents of the User’s
Manual.
The User’s Manual contains exclusive data under the protection of law of copyright. All rights reserved.
Any individual or organization must not reproduce, amend or translate the any part of the User’s
Manual without prior written approval from ComenCompany.
Edition number of the User’s Manual is subject to upgrade without further notice due to any changes
in software, technical specification or other causes.
The User’s Manual is only applicable to the anesthesia machines AX‐400and AX‐500 manufactured by
the Comen Company.
Warranty
Comen Company will be responsible for the safety, reliability and performance of its products on the
conditions that the following conditions are complied:
 The products are operated as per the User’s Manual;
 The products are installed, maintained and upgraded by personnel approved or authorized by
Comen company.
 Storage environment, working environment and electrical environment of the products conform
to the product specifications;
 The product serial number label or indication of manufacture is clear and legible such that Comen
may identity that the products are authentically manufactured by Comen Company;
 The damages are not caused by human factors (such as dropout by accident, deliberately
sabotage etc.);
Comen Company will provide free warrenty services for all products failures satisfing the Comen's
warrenty conditions. Comen may charge a service fees for any services not within the product's
warrenty. User has to bear all transportation costs (including custom's duties) for sending the products
to Comen.
I

Caution
 This instrument must not be operated at home.
Warning
 It is not a medical treatment device.
Return Purchase
If return purchase is really necessary, please follow the steps given below:
Acquiring the right of return: Contact the After‐sale Service Department of Comen company and
inform it of the serial number of Comen instrument. The serial number can be found on the data plate.
If serial number of an instrument is not clear and legible, return purchase may not be accepted.
Furthermore, please indicate the serial number and date of production of the instrument, and describe
briefly the causes of return purchase

After‐sales Service Provider
Provider: After‐sales Service Department, Shenzhen Comen Medical Instruments Co., Ltd.
Address: No.2 of FIYTA Timepiece Building, Nanhuan Avenue, Gongming sub‐district, Guangming New
District, Shenzhen, 518106, Guangdong, China
Tel: +86 755 26431236
Fax: +86 755 26431232
Service hotline: 400‐700‐9488
ZIP: 518106

II

Preface
This User’s Manual describes the performance, operating procedures and other safety messages of
anesthesia machines AX‐400 and AX‐500manufactured by the Company. The manual offers the best
starting point for a new user to begin operating the anesthesia machines.
Construction and Composition
The product is composed of a gas source inlet assembly, an anesthesia ventilator, a flowmeter
assembly, a principal machine, an anesthesia vaporizer assembly and a breathing system.
Scope of Application
The product is applicable to the inhaling anesthesia and respiration management during the surgical
operation.
Figure
All figuresin this User’s Manual are given for reference only. The menus, setup and parameters given in
the figures may be not completely consistent with those that you see on the anesthesia machine.
Customs and Usages
 →: The symbol is used to indicate the opera onal procedures.
 [Characters]: Used to indicate the character strings of software.
Product life
The expected service life of this product is 5 years.

III

Blank Page

IV

Content
Chapter 1 User Responsibility ............................................................................................. 1-1

1.1 Notes ....................................................................................................................................... 1-1
1.2 Intended Readers .................................................................................................................... 1-1
1.3 Environmental Requirements ................................................................................................. 1-1
1.4 Safety Information .................................................................................................................. 1-2
Chapter 2 Product Overview ............................................................................................... 2-1

2.1 Introduction to the Anesthesia Machine ................................................................................. 2-1
2.1.1 Anesthesia Machine AX‐400 .................................................................................... 2‐1
2.1.2 Anesthesia Machine AX‐500 .................................................................................... 2‐2
2.2 Symbols used in the Manual or on the Equipment ................................................................. 2-2
2.3 Abbreviation of Specific Terms .............................................................................................. 2-7
2.4 System Construction ............................................................................................................... 2-9
2.4.1 Front ......................................................................................................................... 2‐9
2.4.2 Back ........................................................................................................................ 2‐13
2.5 Introduction to the Machine Components ............................................................................ 2-13
2.5.1 Breathing System Components .............................................................................. 2‐14
2.5.2 Anesthesia Vaporizer .............................................................................................. 2‐15
2.5.3 Control of Anesthesia Ventilator ............................................................................ 2‐16
2.5.4 Auxiliary Output Power Supply .............................................................................. 2‐17
2.5.5 Serial Port ............................................................................................................... 2‐18
2.5.6 USB Port ................................................................................................................. 2‐18
2.5.7 Network Port .......................................................................................................... 2‐18
2.5.8 Equal‐potential Earthing ........................................................................................ 2‐18
Chapter 3 Basic Operations and Guidance ........................................................................ 3-1

3.1 Turn on the system.................................................................................................................. 3-1
3.2 Configure Volume for Alarms, Prompts and Key Operations ................................................ 3-2
3.3 Turn on/off Volume Alarm Switch.......................................................................................... 3-3
3.4 Set the High/Low Alarm Limits ............................................................................................. 3-3
3.5 Set Parameters of Ventilator ................................................................................................... 3-4
3.5.1 Set Tidal Volume ...................................................................................................... 3‐4
3.5.2 Set Respiratory Rate ................................................................................................. 3‐5
3.5.3 Set Inspiratory:Expiratory time ratio ........................................................................ 3‐5
3.5.4 Set Inspiratory Pause ............................................................................................... 3‐5
3.5.5 Set Inspiratory Pressure ........................................................................................... 3‐5
3.5.6 Set Limiting Pressure ................................................................................................ 3‐5
3.5.7 Set Positive End‐Expiratory Pressure ....................................................................... 3‐6
3.5.8 Set Pressure Slope .................................................................................................... 3‐6
3.6 Control of Anesthesia Ventilator ............................................................................................. 3-6
3.6.1 Manual/Spont Mode ................................................................................................ 3‐6
3.6.2 Mechanical Ventilation Mode .................................................................................. 3‐7
3.7 Compliance of Circuit .......................................................................................................... 3-10
V

3.8 Fresh Air Compensation ....................................................................................................... 3-10

3.9 Timer..................................................................................................................................... 3-10
3.9.1 Start Timer ............................................................................................................. 3‐11
3.9.2 Stop Timer ............................................................................................................. 3‐11
3.9.3 Reset Timer ............................................................................................................ 3‐11
3.10 Parameter Monitoring Of Ventilator ..................................................................................... 3-11
3.10.1 Parameter Display .................................................................................................. 3‐12
3.10.2 Pressure Monitoring .............................................................................................. 3‐13
3.10.3 Tidal Volume Monitoring ....................................................................................... 3‐13
3.10.4 Volume Monitoring ................................................................................................ 3‐13
3.10.5 OxygenConcentration Monitoring ......................................................................... 3‐13
3.11 Turn off the system ............................................................................................................... 3-14
Chapter 4 Operational Readiness Inspection .................................................................... 4-1

4.1 Preoperative Test .................................................................................................................... 4-1
4.1.1 Test Interval .............................................................................................................. 4‐1
4.1.2 Before the Anesthesia Machine is used by the First Patient Every Day ................... 4‐2
4.1.3 Before Anesthesia Machine is used by Each Patient ................................................ 4‐2
4.2 Check the System ................................................................................................................... 4-2
4.2.1 Gas Supply Pipeline and Gas Cylinder Testing .......................................................... 4‐3
4.2.2 Monitoring without O2 Sensor ................................................................................ 4‐4
4.2.3 Monitoring with O2 sensor ....................................................................................... 4‐6
4.3 Assembling of Anesthesia vaporizer ...................................................................................... 4-7
4.4 Anesthesia vaporizer Backpressure Testing............................................................................ 4-7
4.5 Alarm Tests ............................................................................................................................. 4-8
4.5.1 Test the O2 Concentration Monitoring and Alarms ................................................. 4‐8
4.5.2 Test the Minute Volume (MV) Alarm ....................................................................... 4‐9
4.5.3 Test the Apnea Alarm ............................................................................................... 4‐9
4.5.4 Test the Sustained Airway Pressure Alarm ............................................................. 4‐10
4.5.5 Test the High Paw Alarm ........................................................................................ 4‐10
4.5.6 Test the Low Paw Alarm ......................................................................................... 4‐10
4.5.7 Test the CO2 Monitor Alarm .................................................................................. 4‐11
4.6 Breathing System Testing ..................................................................................................... 4-11
4.6.1 Bellows Leak Tightness Testing .............................................................................. 4‐11
4.6.2 Breathing System Leak Test in Mechanical Ventilation Mode ............................... 4‐12
4.6.3 Breathing System Leak Test in Manual Ventilation Mode ...................................... 4‐13
4.6.4 APL Valve Accuracy Testing .................................................................................... 4‐14
4.6.5 Test respiration Check Valve ................................................................................... 4‐14
4.7 Ventilator Testing .................................................................................................................. 4-15
4.8 AGSS Transmission and Absorption System Testing ........................................................... 4-15
4.8.1 Leakage Test Conducted to the Connector of the AGSS and the Exhaust Gas Outlet of
Anesthesia Machine .............................................................................................................. 4‐16
Chapter 5 Installation and Connection .............................................................................. 5-1

5.1 Assemble the Breathing System ............................................................................................. 5-1
5.1.1 Assemble the Breathing System............................................................................... 5‐3
VI

5.1.2 Assemble the Manual Support Column ................................................................... 5‐4
5.1.3 Assemble the Manual Respiration Leather Bag ....................................................... 5‐5
5.1.4 Assemble the Bellows .............................................................................................. 5‐5
5.1.5 Assemble the Flow Sensor ....................................................................................... 5‐7
5.1.6 Assemble the Respiration Hose and Y‐piece ............................................................ 5‐8
5.1.7 Assemble the Oxygen Sensor ................................................................................... 5‐8
5.1.8 Assemble the Gas Channel Manometer .................................................................. 5‐9
5.2 Install the Canister (carbon dioxide absorbent) .................................................................... 5-10
5.3 Replace the Canister (carbon dioxide absorbent) ................................................................. 5-13
5.4 Replace CO2 Absorbent ........................................................................................................ 5-14
5.5 Connection of Gas Supplies ................................................................................................. 5-15
5.5.1 Pipeline Inlets ......................................................................................................... 5‐16
5.5.2 Exhaust Emission .................................................................................................... 5‐16
5.6 Assemble the Anesthesia Vaporizer ...................................................................................... 5-17
5.6.1 Assemble the Anesthesia Vaporizer ....................................................................... 5‐17
5.6.2 Replenish Anaesthetics .......................................................................................... 5‐18
5.6.3 Discharge Anaesthetics .......................................................................................... 5‐18
5.7 Assemble Plug-in Module .................................................................................................... 5-19
5.7.1 AssembleCO2 Module ............................................................................................ 5‐19
5.7.2 Assemble SidestreamAG Module ........................................................................... 5‐21
5.7.3 Disassemble CO2 Module ...................................................................................... 5‐21
5.7.4 Disassemble AG Module ........................................................................................ 5‐22
5.8 AGSS Transmission and Absorption System ....................................................................... 5-22
5.8.1 Structural Composition of AGSS............................................................................. 5‐22
5.8.2 Assemble the AGSS ................................................................................................ 5‐23
5.8.3 Effluent gas treatment system ............................................................................... 5‐25
5.9 O2 Dual Channel Inlet Fitting .............................................................................................. 5-26
Chapter 6 Alarm ................................................................................................................... 6-1

6.1 Overview ................................................................................................................................ 6-1
6.1.1 Alarm Types .............................................................................................................. 6‐1
6.1.2 Alarm Levels ............................................................................................................. 6‐2
6.2 Alarm Modes .......................................................................................................................... 6-2
6.2.1 Visual Alarm ............................................................................................................. 6‐3
6.2.2 Audible Alarms ......................................................................................................... 6‐3
6.2.3 Alarm Messages ....................................................................................................... 6‐3
6.2.4 Alarm Parameter Flickering ...................................................................................... 6‐4
6.2.5 Alarm Status Icons ................................................................................................... 6‐4
6.3 Set the Alarm Volume ............................................................................................................. 6-4
6.4 Set the Alarm Limits ............................................................................................................... 6-4
6.4.1 Set the Alarm Limits of Ventilator ............................................................................ 6‐4
6.4.2 Set the CO2 Alarm Limits .......................................................................................... 6‐6
6.4.3 Setting AG Warning Limits ....................................................................................... 6‐7
6.5 Set the Alarm Levels............................................................................................................... 6-7
6.6 Set the Cardio-pulmonary Bypass Alarm ............................................................................... 6-8
VII

6.7 Alarm Mute............................................................................................................................. 6-8

6.7.1 Set the Alarm Mute .................................................................................................. 6‐8
6.7.2 Cancel the Alarm Mute ............................................................................................ 6‐9
6.8 Alarm Countermeasures ......................................................................................................... 6-9
6.9 Types of Detection Alarm System .......................................................................................... 6-9
Chapter 7 Physiologic Alarms and Technical Alarms ....................................................... 7-1

Chapter 8 CO2Monitoring ................................................................................................... 8-1
8.1 Overview ................................................................................................................................ 8-1
8.2 Identification of CO2 Monitoring ........................................................................................... 8-2
8.3 Sidestream CO2 Module ......................................................................................................... 8-2
8.3.1 Measuring Steps and Checks ................................................................................... 8‐2
8.3.2 Set the CO2 ............................................................................................................... 8‐4
8.3.3 Failure Handling ....................................................................................................... 8‐6
8.3.4 Calibration ................................................................................................................ 8‐6
8.4 Symbols .................................................................................................................................. 8-7
8.5 Analyzer leaning ..................................................................................................................... 8-8
8.6 Patent and brand ..................................................................................................................... 8-8
8.7 Lighting signals of the anaesthetic module ............................................................................ 8-9
8.8 Adverse impact on performance ............................................................................................. 8-9
8.9 Warnings ............................................................................................................................... 8-10
8.10 Sampling line clogged .......................................................................................................... 8-12
8.11 Waste gas discharge .............................................................................................................. 8-12
8.12 Consumables......................................................................................................................... 8-12
8.13 Maintenance.......................................................................................................................... 8-12
Chapter 9 Monitoring of Anaesthetic Gas.......................................................................... 9-1

9.1 Overview ................................................................................................................................ 9-1
9.2 Measurement Principle of Anaesthetic Gas ............................................................................ 9-1
9.3 MAC(Minimum Alveolar Concentration)Calculation ............................................................ 9-2
9.4 Selecting Oxygen Sensors ...................................................................................................... 9-2
9.5 To identify the AG Module ..................................................................................................... 9-3
9.6 Measurement Steps and Inspection Prior to Use .................................................................... 9-4
9.7 Set up AG ............................................................................................................................... 9-5
9.7.1 Set up work mode .................................................................................................... 9‐6
9.7.2 Set the Units ............................................................................................................. 9‐6
9.7.3 O2 Compensation .................................................................................................... 9‐7
9.7.4 Zeroing ..................................................................................................................... 9‐7
9.7.5 Turn on CO2 Waveform ............................................................................................ 9‐7
9.8 Anaesthetic replacement ......................................................................................................... 9-8
9.9 Symbols .................................................................................................................................. 9-8
9.10 Analyzer leaning ..................................................................................................................... 9-8
9.11 Patent and brand ..................................................................................................................... 9-8
9.12 Lighting signals of the anaesthetic module ............................................................................ 9-8
9.13 Adverse impact on performance ............................................................................................. 9-8
VIII

9.14 Warnings ................................................................................................................................. 9-9

9.15 Sampling line clogged ............................................................................................................ 9-9
9.16 Waste gas discharge ................................................................................................................ 9-9
9.17 Consumables........................................................................................................................... 9-9
9.18 Maintenance............................................................................................................................ 9-9
Chapter 10 Logs ................................................................................................................ 10-1

10.1 Alarm Log............................................................................................................................. 10-1
Chapter 11 Maintenance, Cleaning and Sterilization .................................................... 11-1

11.1 Shell Cleaning and Sterilization of Anesthesia Machine ...................................................... 11-2
11.2 Remove and Assemble the Components Allowing Cleaning and Sterilization of the Breathing
System 11-2
11.2.1 Disassemble the Absorber ..................................................................................... 11‐4
11.2.2 Disassemble the Oxygen Sensors ........................................................................... 11‐4
11.2.3 Disassemble the respiration hose and Y‐piece ...................................................... 11‐5
11.2.4 Disassemble the Manual Respiration Leather Bag ................................................. 11‐5
11.2.5 Disassemble the Gas Channel Manometer ............................................................ 11‐6
11.2.6 Disassemble the Manual Support Column............................................................. 11‐6
11.2.7 Disassemble the Bellows Assembly ....................................................................... 11‐7
11.2.8 Disassemble the Flow Sensor ................................................................................. 11‐9
11.2.9 Disassemble Expiratory check valve (unidirectional valve) Assembly ................... 11‐9
11.2.10 Disassemble Inspiratory check valve (unidirectional valve) Assembly ................ 11‐10
11.2.11 Disassemble the Breathing System ...................................................................... 11‐10
11.2.12 Disassemble the AGSS Transmission and Absorption System .............................. 11‐11
11.3 Clean, Sterilize and Assemble the Breathing System ......................................................... 11-14
11.3.1 Breathing System ................................................................................................. 11‐16
11.3.2 Manual Respiration Leather Bag .......................................................................... 11‐16
11.3.3 Breathing Mask .................................................................................................... 11‐16
11.3.4 Respiration Check Valve Assembly ....................................................................... 11‐16
11.3.5 Bellows Assembly ................................................................................................. 11‐17
11.3.6 Canister (carbon dioxide absorbent) .................................................................... 11‐18
11.3.7 Respiration Pipeline and Y‐piece .......................................................................... 11‐18
11.3.8 Flow Sensor .......................................................................................................... 11‐18
11.3.9 Oxygen Sensor ..................................................................................................... 11‐19
11.3.10 AGSS Transmission and Absorption System ......................................................... 11‐19
11.3.11 Battery .................................................................................................................. 11‐20
Chapter 12 Maintenance and Failure Recovery ............................................................ 12-1

12.1 Maintenance Philosophy....................................................................................................... 12-1
12.2 Maintenance Schedule .......................................................................................................... 12-2
12.3 Maintenance of Breathing System ........................................................................................ 12-2
12.4 O2 Calibration ....................................................................................................................... 12-3
12.4.1 21% O2 Calibration ................................................................................................. 12‐3
12.4.2 100% O2 Calibration ............................................................................................... 12‐4
12.5 Gas Channel Manometer Zeroing ......................................................................................... 12-5
IX

12.6 Maintain AGSS Transmission System .................................................................................. 12-5

12.6.1 Maintain the Hose of AGSS Transmission System .................................................. 12‐5
12.6.2 Maintain the Filter Gauze of AGSS Transmission System....................................... 12‐6
12.7 Remove the Water Accumulated in Breathing System ......................................................... 12-6
12.8 Drain Way of Manual Drain Valve ....................................................................................... 12-6
Chapter 13 Appendix ........................................................................................................ 13-1

Chapter 14 Installation and Specifications ..................................................................... 14-1
14.1 System Pneumatic Circuits ................................................................................................... 14-1
14.1.1 Pneumatic Circuit Diagram .................................................................................... 14‐1
14.1.2 Gas Supply .............................................................................................................. 14‐2
14.1.3 O2 Flow .................................................................................................................. 14‐3
14.1.4 Air and N2O ............................................................................................................ 14‐3
14.1.5 Mixed Gas ............................................................................................................... 14‐4
14.2 Electrical Connections .......................................................................................................... 14-4
14.2.1 Electrical Circuit Diagram ....................................................................................... 14‐4
14.2.2 Component List ...................................................................................................... 14‐4
14.3 GB9706.1 and IEC 60601-1Applied Standard for Classification and Components of Products
14-5
14.4 Power Supply........................................................................................................................ 14-6
14.4.1 Power Cord ............................................................................................................. 14‐7
14.5 Specifications for CO2 and AG modules .............................................................................. 14-7
14.5.1 Specifications of ISATM(CO2, AG)sidestream gas analyzer ...................................... 14‐7
14.5.2 Electromagnetic compatibility of the CO2 and AG modules ................................ 14‐11
14.6 EMC and Radio Management Compliance ........................................................................ 14-14
14.7 Physical Specifications ....................................................................................................... 14-17
14.8 Environmental Specifications ............................................................................................. 14-18
14.9 Performance Specifications ................................................................................................ 14-18
14.9.1 Gas Circuit Specifications ..................................................................................... 14‐19
14.9.2 Gas Supply ............................................................................................................ 14‐19
14.9.3 Rapid Oxygenation ............................................................................................... 14‐19
14.9.4 Breathing System Specifications .......................................................................... 14‐19
14.10 Principle and Parameter Specifications of the Ventilator ................................................... 14-21
14.10.1 Principle ............................................................................................................... 14‐21
14.10.2 Parameter Specifications ..................................................................................... 14‐22
14.10.3 Accuracy of Ventilator .......................................................................................... 14‐23
14.11 Principle and Specifications of Oxygen Sensors ................................................................ 14-24
14.11.1 Principle of Oxygen Sensor .................................................................................. 14‐24
14.11.2 Specifications of Oxygen Sensors ......................................................................... 14‐25
14.12 Specifications of AGSS Transmission and Absorption System .......................................... 14-25
14.13 Alarm Specifications .......................................................................................................... 14-26
14.14 AnaestheticVaporizer Specifications .................................................................................. 14-26

X

Chapter 1 User Responsibility
1.1 Notes

The product shall be assembled, operated, maintained and repaired as per the User’s Manual. The
product must be subjected to regular inspections. In case the product requires replacement and
maintenance due to fault, unserviceability, damage/loss/wearing/deformation or contamination of
components, contact immediately local customer service center or agent of Comen for help. The
product and any components of the product must be repaired by trained personnel as per the written
instruction provided by the Company. The product must not be modified without written approval from
Shenzhen Comen Medical Instruments Co., Ltd.User of the product shall undertake full responsibility of
any faults caused by misapplication, improper maintenance/repair, damage, or replacement conducted
by anybody who is not authorized by Shenzhen Comen Medical Instruments Co., Ltd
1.2 Intended Readers

The User’s Manual is only applicable to anaesthetists who had participated in vocational trainings.
Unless otherwise stated, information offered herein is only applicable to the anesthesia machines
AX‐400 and AX‐500manufactured by the Company.
1.3 Environmental Requirements

Warning
 The product and its correlative standalone assemblies must not be applied in nuclear magnetic
resonance (MRI) environment.
 The parts contacting the patient are free of natural emulsion.
 No hazardous substances are generated by the part of this product contacting with anesthetic
agent.
 No hazardous substances are generated by the mixture of the air source of this product and
anesthetic agent.
 To avoid explosion hazards, inflammable anaesthetics such as ether and cyclopropane must
not be applied in the equipment. Only the non-inflammable anaesthetics conforming to IEC
60601-2-13 and GB9706.29may be adopted. The equipment allows the adoption of
non-flammable anaesthetics like enflurane, isoflurane, or sevoflurane, and only 1 type of
anaesthetics may be applied at one time.
 Discarded anesthesia machines and packaging materials must be disposed in accordance with
local relevant laws and regulations or wastes treatment schedule specified by the hospital.
1‐1

In addition, they must be put in places out of the reach of children, and corresponding
measure shall be taken to prevent them form doing harm to the ambient environment.
1. Normal Working Condition
Operating ambient temperature: 10°C ~ 40°C;
Operating ambient relative humidity: 15% ~ 95%, non-condensation;
Atmospheric pressure: 70.0kPa~106.0kPa.
2. Power Supply:
AC: 220-240V ~ 50/60Hz3.5A, 100-120V ~ 50/60Hz 7.0Athe anesthesia machine is equipped with
built-in chargeable batteries;
Gas supply: dry clean compressed medical-use gas of 0.28~0.6MPa.
3. Storage and Transportation Condition.
Storage ambient temperature: -20°C~60°C (oxygen battery: -20°C~50°C);
Storage ambient relative humidity: 10 % ~95%, non – non-condensation;
Atmospheric pressure: 50.0kPa~106.0kPa
1.4 Safety Information

Warning
 To warn you of the conditions where serious consequence, disadvantageous matters or danger may
occur. Failure to comply with the warning will result in severe personal injury or death of the user or
the patient.
CAUTION
 To indicate potential danger or unsafe operation. If not avoided, it may lead to mild personal injury,
product malfunction, damages or property loss. It may also give rise to more severe harm.
Attention
 To emphasize the critical announcements and provide explanations so as to better use this product.
1‐2

Note
 To provide extra consultation to explain the sense of the entence.
Attention
 Please install the equipment in the place where is convenient for observation, operation and
maintenance.
1‐3

Chapter 2 Product Overview

This chapter gives an overview of the anesthesia machine and its functions.
2.1 Introduction to the Anesthesia Machine

An anesthesia machine is a minitype, integrated and intuitionistic anesthesia delivery system that is
characterized by its advanced design and is equipped with the gas‐feed, respiration monitoring and
breathing systems. The anesthesia machines AX‐400and AX‐500 are applicable to the respiration
anesthesia and respiration management of adult/child patients in process of operations, and the
respiration, AG and CO2 monitoring and data management occurring in process operations are
combined together.
Anesthesia machine features log storage and allows you to review trend data..
Log storage: Capable of storing at least 2000 setup logs, including technical alarm logs, physiologic
alarm logs,indicate logs and setting logs.
Trend: Allowing you to view the data stored in the 60‐hour trend table.
2.1.1 Anesthesia Machine AX-400
Fig 2‐1 Anesthesia Machine AX‐400
2‐1

2.1.2 Anesthesia Machine AX-500

Fig 2‐2 Anesthesia Machine AX‐500
2.2 Symbols used in the Manual or on the Equipment
Notes Symbol
Maximum supporting capacity of the top plate is 20kg
Used to adjust the overhead illumination

2‐2

Notes Symbol
The maximum bearing weight of the entire machine is
210kg.
Maximum supporting capacity of the workbench is 20kg
The maximum bearing weight of the bottom drawer is 3kg.
The maximum bearing weight of the loop hook is 1kg.
General warning,caution,risk of danger

High voltage warning

Flowmeter back lighting

Flow regulation flag
Power‐supply AC indicator lamp

Battery indicator lamp

Operating light
Battery flag

Mute

Standby

An anesthesia‐vaporizer pedestal labeling
Oxygen flow meter flag

N2O flowmeter flag

Air‐flow meter flag

2‐3

Notes Symbol
Oxigen flush flag
CO2 module relevant flag CO2
AG module relevant flag AG
O2、N2O、AIR
Gas supply inlet

280~600kPa
Equal‐potential post flag

Protective grounding flag

System turn‐on flag

System turnoff flag

Circuit removal flag
Manual drain valve flag

CO2absorber installation and lockup flag

AGSS gas vent
PEEP branch gas vent
Isolation transformer
Pipeline Pipeline
Insp
Inspiratory/expiratory flag
Exp
Inspiratory/expiratory flapper removal/assembling flag

2‐4

Notes Symbol
Autoclavable
NotAutoclavable

Oxygen cell flag

BY‐Pass flag

APL valve

Bag position/Manual ventilation

Mechanical ventilation

Material explanation
Maximum volume of Canister (carbon dioxide
absorbent)
Canister (carbon dioxide absorbent) components
Bellows cover’s sealing ring on‐the‐top flag

BF‐type equipment flag

USB port
Hot Caution!

Oxygen pressure gauge flag and standby gas‐cylinder
oxygen pressure gauge flag

Nitrous oxide gauge flag and standby gas‐cylinder
nitrous oxide gauge flag

Air gauge flag

2‐5

Notes Symbol
Power‐supply general input (220 to 240V)

Power‐supply general input (100 to 120V)

Auxiliary output circuit breaker flag (220 to 240V) 3.0A
Auxiliary output circuit breaker flag (100 to 120V) 4.0A
Auxiliary output socket flag (220 to 240V)

Auxiliary output socket flag (100 to 120V)

Serial port flag

Auxiliary oxygen‐supply outlet flag

Auxiliary oxygen‐supply flow meter flag
Production date mark

MR Unsafe

Instruction sign “Follow the
instructions for use”

Anti/defibrillation BF‐type application part

Serial no.

Upwards
2‐6

Notes Symbol
Fragile articles
Maximum number of piling layers
Keep dry
Banned back transport packaging
center of gravity
recyclable
symbol for recovery/recyclable
Temperature limitation

Humidity limitation

Atmospheric pressure limitation

2.3 Abbreviation of Specific Terms

2‐7

Abbrev Definition
C:
Compl Compliance
E
EtCO2 Expiratory-end tidal CO2 concentration
F
F-V Flow-Volume loop
FI Inspired gas concentration
FiO2 Fraction of inspired oxygen
FiCO2 Fraction of inspired CO2
I
I:E Inspiratory:Expiratory time ratio
Insp Pause
M
MV Per minute ventilation
O
O2 Oxygen
P
Paw Airway pressure
PCV Pressure‐control ventilation
PEEP Positive end expiratory pressure
Pinsp Inspiratory pressure
Plimit Limiting pressure
Ppeak Peak pressure
Pplat Plateau Pressure
ΔPps Support pressure
R
Raw Resistance
S
SIMV-PC Synchronous intermittent mandatory ventilation‐
pressure control (pressure controlled)
SIMV-VC Synchronous intermittent mandatory ventilation–
volume control (volume controlled)
T
TV Tidal volume
Tvexp Expiratory tidal volume
TVinsp Inspiratory tidal volume
Tinsp Inspiration time
Tslope Pressure slope
Tip:Ti Inspiratory pause
V
VCV Volume control ventilation
Vol Volume
2‐8

2.4 System Construction

2.4.1 Front
3
4
5
2
6
1
10
7
9

8
Fig 2‐3 Front View of Anesthesia Machine AX‐400

1 Flow control 6 System switch
2 AG/CO2Mode area 7 Oxygen flush button
3 Ventilator/monitor display 8 Pedal brake
4 Pedestal of anesthesia vaporizer 9 Oxygen battery end cap
5 Pipeline manometer 10 Breathing system
2‐9

The Control Functions to be implemented through the Front of Anesthesia Machine AX‐400
Item Name Notes
Turn anticlockwise the control knob in increase the flow, or turn it clockwise
to reduce the flow. The system switch must be turned on such that gas may
flow, as shown in the figure below:
Flow control
2
Set the switch to its position “ ” to enable gas input and turn on the system;
set the switch to its position “ ” to turn off gas input and turn off the system.
As shown in the figure below:
7 System switch
Push the ‘O2 +’ oxygen flush Button to offer high-flow oxygen to the
breathing system.
8 Oxygen flush button
Depress at least 2 brake pedals downward by foot, the anesthesia machine

may be braked, as shown in the figure below:
10 Pedal brake
2‐10

10

9
1 8
7
2

3

4

5

6

Fig 2‐4 Front View of Anesthesia Machine AX‐500

1 AG/CO2Mode area 6 Oxygen flush button
2 Flow control 7 System switch
3 Breathing system 8 Pipeline manometer
4 Oxygen battery end cap 9 Anesthesia vaporizer
5 Central brake 10 Ventilator / monitor display
2‐11

The Control Functions to be implemented through the Front of Anesthesia MachineAX‐500
Item. Name Notes
Turn anticlockwise the control knob in increase the flow, or turn it
clockwise to reduce the flow. The system switch must be turned on such that
gas may flow, as shown in the figure below:
Flow control
2.
Set the switch to its position “ ” to enable gas input and turn on the system;
set the switch to its position “ ” to turn off gas input and turn off the
system, as shown in the figure below:
6 System switch
Push the ‘O2 +’, oxygen flush button to offer high-flow oxygen to the
breathing system.
oxygen flush
7
button
2‐12

2.4.2 Back
1 2
6 3

5

4

Fig 2‐5 The Back of Anesthesia Machines AX‐400 and AX‐500
General supply socket and its system circuit

1 4 Anaesthetic Gas Scavenging System
disconnecting switch
Power-supply auxiliary output-socket disconnecting
2 5 Pipeline gas connector
switch
3 Factory calibration port 6 Power-supply auxiliary output socket
2.5 Introduction to the Machine Components
Warning
 Beware of explosion hazard. Never use inflammable anaesthetics in the system.
2‐13

 Never use antistatic respiratory tubes and face masks, which may cause a fire if they are used
nearby surgical equipments for high frequency surgery.
2.5.1 Breathing System Components
11 12
10
13
9
8 14
7
6 15
5 16
4
3

2 1

Fig 2‐6Breathing System of Anesthesia Machine
1 Expiratory flow sensor or flow port adapter 9 Pressure gauge (airway)
2 Canister (carbon dioxide absorbent) 10 Bellows assembly (mechanical ventilation)
3 Canister release 11 Manual bag port
4 Manual drain valve 12 Gasbag support arm
5 Leak test plug 13 Bag/mechanical ventilation switch
6 Respiratory tube hook 14 Inspiratory check valve (unidirectional valve)

Expiratory check valve (unidirectional
7 15 Inspiratory flow sensor or flow port adapter
valve)
8 APL (adjustable pressure limiting) valve 16 Oxygen battery interface

2‐14

No. Item Notes
In manual/independent mode, adjust the pressure limit of breathing
system. Its scale marks may indicate the approximate pressure values.
Adjust it clockwise to increase the value, or adjust it anticlockwise to
reduce the value. The minimum scale is “MIN”, and the maximum
scale is “75”.
8 APL valve
Artificial gasbag suspension arm
10 Gasbag support column
Select manual/independent (gasbag) or volume control (ventilator).

When manual/independent is selected, set the manual switch to its
position “Manual” ( ). If volume control is selected, set the
mechanical control switch to its position “Mechanical Control” ( ).
Bag/mechanical ventilation
13 switch

2.5.2 Anesthesia Vaporizer

Anesthesia machine are designed to work with Dräger Series anesthesia vaporizers
2‐15

fornon‐flammable anaesthetic gases fed from Selectatec® (registered trademark of
Ohmeda)fixed/interlocking devices.
CAUTION
 Please refer to the user’s manual delivered along with the anesthesia vaporizer for specific
information about relevant anesthesia vaporizers.
2.5.3 Control of Anesthesia Ventilator
2.5.3.1 Optional Functions in Ventilation Mode

Various ventilation modes may be selected and configured for anesthesia machine
 VCV
 PCV
 Manual/Spont
2.5.3.2 Control Panel

The control components of an anesthesia ventilator include:
 Buttons
 Touch-control display screen
 Control knobs
1 2 3 4 5
6
19 7
8
18
9
17
16 10
15 14 13 12 11
Fig 2‐7Control Panel of Anesthesia Machine
2‐16

1 Current Ventilation Mode 11 Control knob

2 Patient type display 12 Timer
3 Alarm Message Area 13 Ventilations Mode and Setting Parameters Area
4 System Date and Time 14 Pressure and volume histograms
5 Main Power Supply and Battery Status Icon 15 Battery status indicator
6 Button to enter Standby mode 16 Working indicator
7 Monitoring values of ventilator 17 AC power indicator
8 Button to mute alarm 18 Area for monitoring of anaesthetic gases
concentration
9 Area for monitoring of Gas module and O2 19 Alarm indicator
concentration
10 Area of system prompts
2.5.4 Auxiliary Output Power Supply
Auxiliary output power supply is a type of safe and effective power supply that is alternating current
output by isolation transformer, and mainly serves as auxiliary power supply for patient monitoring
systems.
Warning
 IEC 60601-1-1 and GB9706.15 is applicable to connection of all medical-use electrical rooms
and connection of at least 1 medical-use electrical equipment to 1 or more non-medical-use
electrical equipment. Even if there were no functional connection between single
components of equipment, a medical-use electrical system is established once they are
connected to 1 auxiliary network power outlet. If multiple equipment are connected to the
auxiliary network power outlet, a risk (namely, leakage current rises and exceeds the
allowable limits) may take place.
 To configure the auxiliary output power outlet, the instruments connected to the auxiliary
output power outlet shall fall within the voltage/current specifications of the auxiliary
output power outlet. The instruments connected to the auxiliary output power outlet shall
be equipment specified by the manufacturer; otherwise, the leakage current may exceed
relevant limits, endanger patient or operator, or even damage the anesthesia machine or
external instruments.
 If your anesthesia machine is not equipped with an isolation transformer, the equipment
connected to the auxiliary output power outlet may increase the leakage current. The
2‐17

leakage current shall be determined regularly. In order to reduce the total leakage current,
we suggest that you select anesthesia machines equipped with isolation transformer.
2.5.5 Serial Port
The symbol “ ” marked on back cover of the instrument indicates the serial port of the
instrument. That port is designed only for factory maintenance to be performed by the Company.
2.5.6 USB Port

The symbol “ ” on the back housing indicates the USB port. This port is used for data
output and software update (by Comen).

2.5.7 Network Port

The symbol “ ” on the back housing indicates the network port. This port is used for
data transmission between the Medical Systems.
Warning
 All the simulation and digital equipment connected with this monitor must be the products
certified by the designated IEC standards (e.g. IEC 60950 Data Processing Equipment
Standard and IEC 60601-1 Medical Equipment Standard)
2.5.8 Equal-potential Earthing
Equal-potential earthing means connecting the shell or metal part of equipment to the ground
lead so as to avoid indirect-contact shock, explosion, fire hazard and transient overvoltage and
interference caused by ground fault, and to protect the personal/equipment safety.
One end equal-potential ground lead shall be connected to the equal-potential ground pole fitted
on the back cover of the instrument, and the other end shall be connected to one of the terminals
of the equal-potential system. If the protective ground system is damaged, the equal-potential
earthed system may undertake the safety function of the protective earthing lead.
Warning
2‐18

 If the protective ground system works unstably, the instrument shall be powered by internal
power supply.
Check whether or not the instrument is kept in good working order prior to each operation.
2‐19

Chapter 3 Basic Operations and Guidance
Warning
 Alarms given by an anesthesia ventilator indicate that the patient is being subjected to
potential risks. The causes of all alarms shall be made certain so as to make sure the safety
of patients.
 If sevoflurane is adopted, adequate fresh gas flow shall be maintained.
 When dry (dewatered) absorber material is exposed to inspiratory anaesthetics, unsafe

chemical reaction may take place. Caution: Do not allow the absorbent to get dry. Once the
system operation is over, turn off all gas supplies.
3.1 Turn on the system

1. Connect the gas supply properly, and make sure that the gas supply is adequately pressurized
(gas supply pressure shall fall within 280 kPa~ 600 kPa).
2. Insert the power plug into the AC power socket. The power indicator goes on. If the battery
level is low at this time, the battery will be charged.
3. The yellow alarm indicator flashes once and then the red indicator flashes once, with the
backup buzzer giving a sound.
4. Set the system switch to its status “ ”.
a) The system enters into its turn-on status, and the LOGO of the Company is shown in the
screen.
b) The system performs a series of self tests automatically, and it enters into the “Leak in
vent mode” once it passes the self-check.
c) Select “Start” and perform “Leak in vent mode” as per the prompts given in the interface,
and access “Leak in bag mode” once the test is passed.
If the equipment fails to pass the test, please conduct a test over again ad per the
procedures given in “4.6.2Breathing System Leak Test in Mechanical Ventilation Mode”.
d) Select “Start” and perform “Leak in bag mode” as per the prompts given in the interface,
and access the “Standby” interface once it passes the test. Here, you may select patient
types “Adult” or “Child”, and select “Ventilation Start” to access the user interface.
If the equipment fails to pass the test, please conduct a test over again ad per the
procedures given in “4.6.3Breathing System Leak Test in Manual Ventilation Mode”.
3‐1

Warning
 To run the equipment for patients, make certain that the system connection is errorless and is
kept in good order and condition, and finish all tests specified in Chapter 4 Operational
Readiness Inspection. If the equipment fails to pass the tests, never use the equipment.
Please contact immediately an authorized service representative to repair the equipment.
 The anesthesia machine is equipped with built-in charge batteries to make sure that the
anesthesia machine may still be used normally in case of power failure. Once the anesthesia
machine is connected to ac supply, it may charge the batteries, disregarding whether or not
it is turned on. In case of sudden power cut, the system can power the anesthesia machine
by its batteries so as to avoid interruption of anaesthetization. When the ac supply resumes
power supply at target time, the system can stop battery feed and enable ac power supply
automatically in order to guarantee normal work of the anesthesia machine.
 Battery feed can be maintained only for a period of time. Once the battery voltage gets too
low, anesthesia machine may give out an advanced alarm, and display the alarm message
[Battery Voltage is too Low] in the technical alarm zone.
Caution
 Avoid short circuit of battery.
 Do not allow the batteries to be charged inside a sealed container.
 Keep batteries away from flammable and explosive materials.
3.2 Configure Volume for Alarms, Prompts and Key Operations

1. Set the system switch to its status ON “ ”.
2. In the user interface, select [Alarm] menu→ Access the [Sound] 1 menu.
3. Set volume in grade “1-8” respectively for [Alarm Sound Volume], [Indicate sound Volume]
1
, [Keytone Volume] 2. The length of cyan bar indicates the current volume grade. If no grid is
cyan, the volume is muted, as shown in the figure below.
3‐2

Fig. 3‐ 1 Interface for Configuring Sound
Note 1: After making certain menu settings, such as in the capacity control menu, on the touch
screen, you need to click “Confirm” key to confirm. Here you can set the volume for the prompt
reminding you of confirmation.
Note 2: After making certain menu settings, such as in the VCV control menu,you need to click
“Confirm” key to confirm. Here you can set the volume for the prompt reminding you of
confirmation.
3.3 Turn on/off Volume Alarm Switch

2. In the user interface, select the volume [Manual/Spont] menu→ Access the [Alarm] menu.
3. Push and turn the “control knob” key to switch over between [ON] or [OFF].
4. Select [ON] or [OFF] , push the “control Knob” to confirm the current option.
5. Turn the “Control Knob” key to return to the [Manual/Spont] menu, and return to the previous
menu.

Fig. 3‐ 2 Manual/Spont Alarm Menu
3.4 Set the High/Low Alarm Limits

3‐3

2. In the user interface, select [Alarm] menu→ Access the [ventilator] or [CO2] 1 menu, and set
the High/low alarm limits for the parameters.

Fig. 3‐ 3 High/Low Alarm Limit Interface
Note 1: See “Alarm setting” given in relevant chapter for details of High/low alarm limits for
parameters of [ventilator] and [CO2] .
3.5 Set Parameters of Ventilator

Parameters of ventilator are configured mainly through “Control Knob” and touch screen
operations. When parameter settings are changed, the prompt bar on the interface displays
“Parameter ** is changed. Please press ‘Confirm’ key to confirm settings”. At this time, the
[Confirm] key of the current ventilation mode menu flashes alternatively in yellow and light blue,
reminding you to confirm settings. If you do not confirm settings within 15 seconds, the previous
parameters before settings will be recovered and the [Confirm] key stops flashing.

Fig. 3‐ 4
3.5.1 Set Tidal Volume

1. Select menu of [VCV] mode→ [TV] .
2. Select the parameter via the control knob or touch control, and rotate the knob to set [TV] to
the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.
3‐4

3.5.2 Set Respiratory Rate

1. Select the menu of ventilation mode→ [Freq] .
2. Select the parameter via the control knob or touch control, and rotate the knob to set [Freq] to
Note
 [Freq] can be configured in [VCV] , [PCV] .
3.5.3 Set Inspiratory:Expiratory time ratio

1. Select the menu of [VCV] or [PCV] mode→ [I:E] .
2. Select the parameter via the control knob or touch control, and rotate the knob to set [I:E] to
3.5.4 Set Inspiratory Pause

1. Select the menu of [VCV]→ [Tip:Ti] .
2. Select the parameter via the control knob or touch control, and rotate the knob to set [Tip:Ti] to
3.5.5 Set Inspiratory Pressure

1. Select the menu of [PCV]mode→ [Pinsp].
2. Select the parameter via the control knob or touch control, and rotate the knob to set [Pinsp] to
3.5.6 Set Limiting Pressure

1. Select the menu of ventilation mode → [Plimit] .
2. Select the parameter via the control knob or touch control, and rotate the knob to set [Plimit] to
3‐5

3.5.7 Set Positive End-Expiratory Pressure

1. Select the menu of ventilation mode → [PEEP] .
2. Select the parameter via the control knob or touch control, and rotate the knob to set [PEEP] to
3.5.8 Set Pressure Slope

1. Select the menu of [PCV]mode → [Tslope] .
2. Select the parameter via the control knob or touch control, and rotate the knob to set [Tslope] to
3.6 Control of Anesthesia Ventilator
Note
 Anesthesia ventilator shall be configured to comply with breathing system in ISO 80601-2-13
and YY 0635.1, together with AGSS in ISO 8835-3 and YY 0635.2。
3.6.1 Manual/Spont Mode

1. Rotate the control knob of the APL valve to adjust the pressure inside the respiratory system to
appropriate range.
2. Set the Bag/mechanical ventilation switch to “Manual” position, and [ Manual/Spont]
will be displayed on the screen.
3. If necessary, press the “quick oxygen charging” button to inflate the leather bag.
4. In [Manual/Spont] mode, the APL valve is used to regulate the peak pressure in the
respiratory system and the air volume in the leather bag. When the pressure in the respiratory
system reaches the threshold, the APL valve is opened to discharge the excessive air in the
breathing system.
The pressure waveform and flow rate waveform are shown in the figure below:
3‐6

Fig. 3‐ 5
Note
 Make sure Manual/Spont mode is always available when this device is used on patients.

3.6.2 Mechanical Ventilation Mode
3.6.2.1 Start Mechanical Ventilation

1. Set the system switch to “ ” (ON) status.
2. Set the proper patient type like [Adult] or [Child] on the user interface.
3. Select [VCV] → [TV] .
4. Enter the setting mode through the “Control Knob” or touch screen operation. Rotate the “Control
Knob” to set a proper value for [TV] , and then confirm the parameter setting via the control knob
or touch operation.
5. Select [VCV] → [Confirm] to confirm parameter settings for all modes.
6. Check ACGO switch, and make sure ACGO is OFF.
7. Set the Bag/mechanical ventilation switch to “Mechanical Control” position..
8. If necessary, press the “Quick Oxygen Charging” button to inflate bellows.
9. Start the mechanical ventilation by pressing the [Ventilation Start] button.
Note
 Make sure all parameters are set properly before starting up the new mechanical ventilation
mode.
3‐7

3.6.2.2 Select Mechanical Ventilation Mode
Ventilator modes are configured mainly through “Control Knob” and touch screen operations.
When switching between ventilation modes, the [Confirm] key of the current ventilation mode
flashes alternatively in yellow and light blue, reminding you to confirm settings. If you confirm
settings within 15 seconds, the ventilator will enter the new mode; otherwise, it will remain in the
current mode.
There are 5 modes for mechanical ventilation:
 VCV
 PCV
3.6.2.2.1 Select VCV Ventilation Mode
1. Select [VCV] tab→ set up parameters like [TV], [Freq] .
2. Select [VCV] tab→ [Confirm] to start the volume control mode.
3. At this time, the current mode "VCV" is displayed at the left top.
3.6.2.2.2Select PCV Ventilation Mode
1. Select [PCV] tab → set up parameters like [Pinsp] , [Freq] .
2. Select [PCV] tab → [Confirm] to start the volume control mode.
3. At this time, the current mode "PCV" is displayed at the left top.
3.6.2.3 Introduction to Ventilation Modes
3.6.2.3.1VCV Mode

Fig.3‐ 6 Waveform of VCV Mode
Under the volume controlled VCV mode, a preset tidalvolume will be provided. According to the
preset [TV] , [Freq] and [I:E] , the airflow delivered in the inspiration phase will be calculated by
the ventilator. The inspiratory flow sensor detects the inhaled tidal volume in real-time fashion,
and the exhaled tidal volume reaches the preset value through the feedback of inhaled tidal
volume. As the output of the ventilator is adjustable, so the compliance of the respiration circuit
system and the influence of the flesh airflow can be compensated.
3‐8

Generally speaking, under this mode, a constant flow is delivered during the inspiration phase,
with the pressure increasing in the lungs; the flow is exhaled fast in the expiration phase, and the
pressure inside the lungs drops rapidly. By setting [Tip:Ti] , the gasdistribution in the patient’s
lungs can be optimized.
Setting [PEEP] (Positive End-Expiratory Pressure) to improve the expiratory-end CO2discharge
and increase oxygenation during the respiratory process.
Settings of VCV Mode:
 TV
 Freq
 I:E
 Tip:Ti
 Plimit
 PEEP
3.6.2.3.2PCV Mode

Fig.3‐ 7 Waveform of PCV Mode
Under the PCV mode, a constant inspiratory pressure will be provided. According to the preset [Freq]
and [I:E] , the inspiratory time can be calculated by the ventilator. The ventilator increases pressure
for patient side of the breathing circuit through a higher initial airflow, and reduce the airflow after
the pressure reaches the preset value in order to maintain the preset inspiratory pressure, until the
respiratory time turns to the expiratory time.
The ventilator pressure sensor monitors the airwaypressure of the patient side of the breathing circuit
in real‐time fashion. The ventilator maintains the preset pressure through the feedback of flow
corresponding to the pressure.
Under the PCV mode, setting [PEEP] also can improve the expiratory‐end CO2discharge and increase
oxygenation during the respiratory process.
3‐9

Settings of PCV Mode:
 Pinsp
 Freq
 I:E
 Tslope
 Plimit
 PEEP
3.6.2.4 Stop MechanicalVentilation

1. Make sure that the manual Circuit has been set before stopping mechanical ventilation, and set
the APL valve at 20cmH2O.
2. Set the Bag/mechanical ventilation switch to “Manual” or directly set the ACGO switch as
the auxiliary outlet, so as to stop mechanical ventilation.
3.7 Compliance of Circuit

Calculate the compressiblevolume in the patient’s circuit:
1. Set the ventilator on the mechanical ventilation mode.
2. Set the TV to around 500 mL
3. Set the Freq to 10 times/minute
4. Set the I:E to 1:1.
5. Set the Plimit to 20 cm H2O
6. Block the patient’s connector of the Y-piece. Pay attention to keep the connector clean.
7. Start mechanical ventilation.
8. Monitor TVexp (Expired Tidal Volume) and Ppeak (Peak Pressure measured in the airway)
TVexp is intended to measure the needed air volume in the patient’s circuit.
The example below shows how to calculate the tubing compliance factor
TVexp／(Ppeak-2.5 1 cmH20)= Compliance Factor; Unit: mL/cm H20
Example: Ppeak=20 cm H20, TVexp =24mL, 24/(20-2.5) =1.4 mL/cm H20
The factor is used to calculate the air compressionvolume in the patient’s circuit. For example, if a
patient needs 30 cmH20 to conduct ventilation, then 42mL (calculated by 30 X 1.4= 42 mL) air shall
be compressed in the tubing at each respiration. The 42 ml air is part of the tidal volume indicated,
but it won’t be delivered to the patient.
Note 1: Force applied in the bellows.
3.8 Fresh Air Compensation

Range of fresh air compensation: 200m L /min~15L/min;
Air composition: oxygen, N2O, air, and anaesthetic.
3.9 Timer
The timer is seated in the right bottom corner of the ventilator interface. It is helpful for an anaesthetist
to record duration of an operation or count time for some special operations during the operation. It is
operated by the control knob and touch control panel. The default state is OFF, as shown in the figure
below.
3‐10

3.9.1 Start Timer

1. Press the control knob or tap [Timer] → [Start] to start the timer.
2. After the timer starts counting, [Start] changes to [Stop] .
3.9.2 Stop Timer

1. Press the control knob or tap [Timer] → [Stop] to stop the timer.
2. After the timer stops counting, the [Stop] changes to [Reset] .
3.9.3 Reset Timer

1. Press the control knob or tap [Timer] → [Reset] to reset the timer.
2. After the limit value turns to “00: 00: 00”, the [Reset] changes to [Start] .
3.10 Parameter Monitoring Of Ventilator

The parameter monitoring of ventilator falls into two categories: waveform monitoring and
parameter monitoring of breathing mechanics.
Currently, the system displays 4 breathing waveforms: pressure waveform, flow waveform, tidal
volume waveform.
The system monitors 16 breathing-related parameters: [Ppeak] , [Pplat] , [PEEP] , [TVexp] ,
[MV] , [Freq] , [FiO2] , [FiCO2] , [EtCO2] , [I：E] , [Pmean] , [TVinsp] , [Compl] , and
[Raw] .
Under the non-standby interface, the parameter interface is divided to the [Waveform]
parameter area in the center and the parameter display area on the right, as shown in the figure
below:
3‐11

Fig.3‐ 8
3.10.1 Parameter Display

The system can display the monitoring parameter in 2 ways: Large Font Interface and
Non-Large Font Interface. In the large font interface, only the parameter values are displayed;
but in the non-large font interface, both the parameter waveform and parameter values are
displayed.
The non-large font interface is adopted by default. You can select a display way by choosing
[Config] → [Setting] → [Big Font] → [On] / [Off] .
The large font interface is shown as below.

Fig.3‐ 9
3‐12

3.10.2 Pressure Monitoring

Under the non-standby interface, you can monitor the airway pressure waveform and the
parameter values of airway peak pressure, platform pressure, positive end-expiratory pressure,
mean pressure.
The unit of the pressure parameter can be configured. Currently, the system provides three
units: [cmH2O], [kPa] and [mbar] , of which the [cmH2O] is the default mode. You can select
one unit by choosing [Config] → [Setting] → [Pressure Unit] .
The display of the airway pressure waveform is optional. To enable/disable this display, you
can select [Config] → [Screen] → [Pressure Wave] → [On] / [Off] .
The display of the [PEEP] is optional. To enable/disable this display, you can select [Maintain]
→ [Config] → [System Config] → [PEEP Display] → [On] / [Off] .
3.10.3 Tidal Volume Monitoring

Under the non-standby interface, you can monitor the real-time flow waveform and expired
tidal volume, inspired tidal volume, per-minute ventilation amount.
The display of the flow waveform is optional. To enable/disable this display, you can select
[Config] → [Screen] → [Flow Wave] → [On] / [Off] .
The display of the [TVinsp] is optional. To enable/disable this display, you can select [Config]
→ [Setting] → [TVi Display] → [On] / [Off] .
3.10.4 Volume Monitoring

Under the non-standby interface, you can monitor the real-time volume waveform.
The display of the volume waveform is optional. To enable/disable this display, you can select
[Config] → [Screen] → [Volume Wave] → [On] / [Off] .
3.10.5 OxygenConcentration Monitoring
3.10.5.1 Turn onOxygen Sensor Monitoring

1. Select [Config] → [Setting] →[O2 Sensor Monitor].
2. Select [On] / [Off] in the [Oxygen Sensor] under [O2 Sensor Monitor] as required.
Caution
3‐13

 When you use the oxygen sensor for the first time or replace the oxygen sensor, please check
whether the oxygen concentration monitoring is accurate. If the monitoring error is obvious,
please calibrate the sensor.
 When the [O2 Sensor Monitoring] is set to [Off] , FiO2 will display a void value, and the sensor
cannot be calibrated; meanwhile, the oxygen concentration monitoring and the related alarms
of the sensor will be disabled.
 When the [O2 Sensor Monitoring] is set to [On] , and the Oxygen Monitoring Source is set to
[Off] , FiO2 will display a void value, and the sensor cannot be calibrated; meanwhile, the
oxygen concentration monitoring and the related alarms of the sensor will be disabled.
 According to international regulatory requirements, the machine shall conduct oxygen
concentration monitoring before applied to patients. If your machine is not equipped with this
function, please conduct oxygen concentration monitoring with a qualified monitor according
with the related global standard.
3.11 Turn off the system

Please follow the steps below to shut down when you do not intend to use the machine:
1. Please ensure the machine can be ended
2. Set the system power switch to “ ”

。
3‐14

Chapter 4 Operational Readiness Inspection
Warning
 Prior to operating the equipment, read the User’s Manual and comprehend the operation and
maintenance of all components.
 If the equipment fails to pass the pre-operation tests, never use it. Please contact the
Company.
 Either to adopt single devices (anesthesia gas delivery system, monitoring devices, alarm
system and protective devices intended to serve an anesthesia systems) or to set up an
anesthesia system, a checklist of the anesthesia system shall be submitted.
4.1 Preoperative Test
4.1.1 Test Interval

Pre-operation tests shall be conducted for the following cases:
Before the anesthesia machine is used by the first patient every day
Before the anesthesia machine is used by each patient.
After anesthesia machine is maintained or is subjected to preventive maintenance.
Table of recommended testing time and test items is given as follows:
Before the anesthesia Before anesthesia
Test items machine is used by the first machine is used by each
patient every day patient
Systematic inspection √
Alarm testing √ √
Gas supply pipeline and gas cylinder testing √
Flow control system testing √
Anesthesia vaporizer installation testing √
Anesthesia vaporizer backpressure testing √
Breathing system leak testing √ √
Oxygen flush charging testing √ √
Check AGSS transmission and absorptive system √ √
4‐1

4.1.2 Before the Anesthesia Machine is used by the First Patient Every
Day
1. Test that the required first aid equipment is kept ready and in perfect condition.
2. Conduct test and verify that the equipment is kept in good order and condition, and the
components are connected correctly.
3. Test and verify the connection of pipeline gas supply system, and verify that the gas
cylinders are already assembed, and the displayed pressure values are correct.
4. Test and verify whether or not the liquid anaesthetic level inside the anesthesia vaporizer is
appropriate, and check whether or not the anesthesia vaporizer fits its soleplate perfectly.
5. Test and verify that the respiration circuit is connected correctly and is kept in good order
and condition; there is enough renewed CO2 absorbent inside the CO2. absorber
6. Connect the exhaust emission system, and verify whether or not the system works well.
7. Turn the system switch to its position “ON”, the system automatically performs a series of
self detection. Verify whether or not the system passes the self detection.
8. If the system passes the self detection, “Automatic circuit leak testing”and “Manual loop
leak testing” may be conducted.
9. Make sure adequate supply of reserved oxygen.
10. Select correct patient types like “adult” or “children”.
11. Start ventilation.
12. Set proper controlling value and alarm limits for the cases.
4.1.3 Before Anesthesia Machine is used by Each Patient

1. If the preparation of “Before the Anesthesia Machine is used by the First Patient Every
Day” is finished, it is unnecessary to conduct the test before the machine is used by the first
case on that very day.
2. Test that the required first aid equipment is kept ready and in perfect condition.
3. Check whether or not the level of liquid anaesthetic inside the anesthesia vaporizer is
appropriate.
4. Check and verify that the respiration circuit is connected correctly and is kept in good order
and condition, and the breathing system is filled with enough absorbent.
5. Conduct gas leak testing of the breathing system.
6. Turn off the APL valve (set it to 30cmH2O)
8. Set proper controlling value and alarm limits for the cases.
4.2 Check the System
Warning
4‐2

 Make sure that the breathing system is connected properly and is kept in good order and
condition.
 Maximum supporting capacity of top support is 20kg.
 Maximum supporting capacity of workbench is 20kg.
Check the system, and make sure that the following requirements are satisfied:
1. Equipment is kept in good order and condition

2. All components are connected correctly.
3. Breathing system is connected properly, and the respiratory pipelineis kept in good order
and condition.
4. Anesthesia vaporizer is locked up in properly position and is filled with enough
anaesthetics.
5. Gas supply system is connected correctly, and its pressure is kept normal.
6. If a standby gas cylinder is available, turn off the valve of the connected gas cylinder.
7. Required emergency equipment is kept ready and in perfect condition.
8. All equipment for gas passage maintenance comfortable as an old shoe and tracheal
intubation are kept ready and in perfect condition.
9. Applied stupefacients and emergency drugs are kept ready.
10. Make sure that the pedal brake or central brake is locked up without damage or looseness,
so that the anesthesia machine cannot be moved.
11. make sure that the breathing system of anesthesia machine is fixed onto the switchover
piece, and verify that the breathing system is already locked up.
12. Connect the power cord to the AC power supply. When AC power supply is connected, the
AC power indicator and battery indicator lamp go on. If they do not go on, the system is not
powered.
13. Make sure the anesthesia machine allows normal turn-on/off.
4.2.1 Gas Supply Pipeline and Gas Cylinder Testing
4.2.1.1 Gas Supply pipeline testing
Caution
 During pipeline ventilation is in use, do not set the standby cylinder valve to position “ON”.
Otherwise, the gas cylinder may be exhausted and result in short supply in case the pipeline
ventilation gets faulty.
4.2.1.2 O2 Pipeline Testing

1. If anesthesia machine is equipped with a standby cylinder, turn off all standby cylinder
valves. Connect O2 pipeline gas supply.
2. Set the System switch to its position “ON” ( ).
3. Adjust the flow control knob to the intermediate level of measuring range.
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4. Make sure that the pressure values indicated by all pipeline manometers range from 280
to600kPa.
5. Cut off O2 pipeline ventilation.
6. As O2 pressure drops, alarms”No O2 Pressure”.
7. Make sure that O2 manometer returns to its zero position.
4.2.1.3 N2O Pipeline Testing

To conduct N2O gas supply pipeline testing, turn on O2 first. For specific operational
procedures of N2O Gas supply pipeline testing, please refer to 4.2.1.2 O2 Pipeline Testing.
Caution
 To conduct N2O gas supply pipeline testing, turn on O2 first, and make sure that the O2 gas
supply pressure ranges from 280 to 600kPa; Otherwise, N2O flow cannot be regulated.
 Being different from O2 pipeline gas feed, when N2O pipeline gas feed is cut off, the system
will not given alarms related to the N2O pressure as N2O pressure drops.

4.2.1.4 Air Pipeline Testing
For specific operational procedures of air pipeline testing, please refer to 4.2.1.2 O2 Pipeline
Testing.
Caution
 Being different from O2 pipeline ventilation, when air pipeline gas feed is cut off, the system
will not given alarms related to the air pressure as air pressure drops.
4.2.2 Monitoring without O2 Sensor

Warning
 Even if fresh gas contains enough O2, it may not always avoid the hypoxemia mixed gas in
breathing system.
 If N2O exists and flows through the system during the testing, it shall be collected and
eliminated as per safe and acceptable methods.
 Improper mixed gas may injure the patients. If the oxygen- lin N2O ked system cannot provide
well-proportioned O2 and N2O, the system shall not be used.
4‐4

Caution
 To avoid damage, please turn on the gas cylinder valve slowly.
 When Backup gas Cylinder Testing is over, turn off the gas cylinder valves if standby
cylinders are not adopted for gas feed.
 Turn the gas flow switches slowly, and do not turn them forcibly when the maximum or
minimum flow range is exceeded, so as not to damage the control valve and result in
control failure. When flowmeter is adjusted to the minimum value, the reading shall be
zero.
Please conduct the flow control system testing as per the following steps when oxygen sensor is
not adopted:
1. Connect pipeline ventilation or turn on gas cylinder valve slowly.

2. Turn clockwise all flow control knobs of flowmeter to the end (minimum flow).
3. Set the system switch to its position “ON” ( ).
4. If electric quantity of battery is not enough or other ventilator malfunction alarms are given,
do not use the system.
5. Adjust all gas flows to the minimum positions.
6. Test the flow increasing of oxygen-N2O linked system;
Turn clockwise O2 and N2O flow control knobs respectively to adjust the flow of O2 and N2O
to the minimum. Turn counterclockwise N2O flow control knob, adjust N2Oflow and set them
to the values given the table below successively. Observe the values of oxygen flow at each step,
and make sure that they meet the requirements listed in the table.
Step N2O flow (L/min) Oxygen flow (L/min)

1 0.6 ≥0.2
2 1.5 ≥0.5
3 3.0 ≥1.0
4 7.5 ≥2.5
7. Test the flow reduction of oxygen-N2O linked system;
Turn clockwise O2 and N2O flow control knobs to adjust the flow of O2 and N2O to at least
9.0L/min and 3L/min respectively. Turn counterclockwise N2O flow control knob, and adjust
N2O flows and set them to the values given the table below successively. Observe the values of
oxygen flow at each step, and guarantee that they meet the requirements listed in the table.
Step N2O gas flow (L/min) Oxygen flow (L/min)

1 7.5 ≥2.5
2 3.0 ≥1.0
3 1.5 ≥0.5
4 0.6 ≥0.2
4‐5

8. Cut off oxygen pipeline supply or turn off oxygen gas cylinder.
Caution
 When O2ventilation is cut off, alarms “No O2 Pressure” may be given as O2 pressure drops.
4.2.3 Monitoring with O2 sensor

To conduct the testing, test the oxygen monitoring device as per “Alarm Testing”. Please
conduct the flow control system testing as per the following steps when transducer is adopted:
1. Connect pipeline ventilation or turn on gas cylinder valve slowly.

2. Turn clockwise all flow control knobs of flowmeter to the end (minimum flow).
4. If electric quantity of battery is not enough or other ventilator malfunction alarms are given,
do not use the system.
5. Adjust all gas flows to the minimum positions.
The following steps 6 and 7 are only applicable to N2O system testing.
Warning
 During steps 6 and 7, the utilized oxygen sensor must be calibrated correctly, and the linked
system must be kept in its functional mode.
 Adjust the testing control only (N2O described in step 6 and O2 described in step 7).
 Adjust N2O before O2, and regulate the flows according to priority.
6. Test the flow reduction of O2-N2O linked system;

 Turn clockwise O2 and N2O flow control knobs respectively to the end (minimum flow).
 Turn counterclockwise the N2O flow control knob slowly.
 Make sure that the O2 flow is increasing, and the measured O2 concentration must be ≥21% in the
whole process.
7. Test the flow reduction of O2-N2O gas linked system:

 Turn N2O flow control knob, and set the N2O flow to 9.0L/min.
 Turn O2 flow control knob, and set the O2 flow to 3L/min or higher.
 Turn counterclockwise the O2 flow control knob slowly.
 Make sure that the N2O flow is increasing, and the measured O2 concentration must be ≥21% in the
whole process.
8. Cut off the O2 pipeline gas feed or turn off the O2 gas cylinder valve.
9. Make sure:
4‐6

 Stop N2O and O2 gas flow, and O2 gas flow is cut off finally.
 If an air supply is connected, air draft shall be maintained.
 Ventilator may give alarm related to inadequate gas supply.
10. Turn clockwise all flow control knobs to the end (minimum flow).
11. Connect the O2 pipeline ventilation or turn on the O2 gas cylinder valve again.
12. Set the system to its standby mode.
4.3 Assembling of Anesthesia vaporizer

Warning
 Only vaporizers of Selected series may be adopted. To conduct testing, ensure that the
anesthesia vaporizer is already locked up.
 Do not remove the locked-out anesthesia vaporizer from the anesthesia machine.
 To assemble 2 anesthesia vaporizers onto 1 anesthesia machine, the 2 anesthesia vaporizers

must not be turned on simultaneously for concentration control.
 The equipment may be connected to an anesthesia concentration analyzer that conforms to

ISO21647. We suggest that the user may assemble an anesthesia concentration analyzer if
an anesthesia vaporizer is available, so as to monitor the output of anesthesia concentration.
 The anesthetic vaporizer cannot be used if it is set between “0” and “ON”.
Caution
 If the top of anesthesia vaporizer is not horizontal, remove the anesthesia vaporizers and
reassemble it. If the anesthesia vaporizer cannot be set level on the underplate of anesthesia
vaporizer, do not use the system.
 Set the locking bar of anesthesia vaporizer to its latched position.
 Lift each anesthesia vaporizer upward in so far as possible such that it may be separated from
the underplate of anesthesia. vaporizer However, do not pull it forward. Be careful! Do not
allow the anesthesia vaporizer to rotate on the underplate of anesthesia vaporizer
4.4 Anesthesia vaporizer Backpressure Testing

Warning
4‐7

 During testing, the anaesthetic comes from the fresh gas outlet. These agents shall be
discharged and collected as per safe and acceptable methods.
 To avoid any damage, turn clockwise the flow control knob to the end (minimum flow or turn
it off) prior to usage.
1. Set the system switch to its position “ON”. An alarm might be given here.
2. Set the O2 flow to 6L/min.
3. Make sure that the O2 flow is constant, and that the floating mark of oxygen flow meter
(for AX-400) or summation flowmeter (for AX-500) may travel freely..
4. Adjust the concentration of anesthesia vaporizer between 0 ~ 1%. The drop of O2 flow
must not be greater than 1L/min in the whole process. If the drop of O2 flow is greater than
1L/min:
 Replace the anesthesia vaporizer with a new one;
 If the drop of O2 flow is smaller than 1L/min after the replacement, the old
anesthesia vaporizer is faulty.
 If the drop of O2 flow is still greater than 1 L/min after the replacement, the
anesthesia machine system is faulty.
5. For each anesthesia, vaporizer steps 2 and 3 shall be conducted.
4.5 Alarm Tests

Anesthesia machine automatically performs self-checking once it is turned on. The alarm lamp
blinks once as per orange -red sequence, and a beep is given out. Boot-strap menu is displayed
in the screen. When “Leak in vent mode” and “Leak in bag mode”is finished, the equipment
accesses its standby interface directly. This indicates that the audible and visual alarm indicator
works normally.
Caution
 During alarm testing, operator shall stay in a position where the alarm lamps and alarm
suggestive prompts may be observed and the alarm tone may be heard.
4.5.1 Test the O2 Concentration Monitoring and Alarms
Warning
 In accordance with international laws and regulations, oxygen concentration shall be

monitored during the equipment is applied on a patient. If your equipment is not provided
with the said function, please use a monitoring instrument conforming to corresponding
international standards to monitor the oxygen concentration.
4‐8

Caution
 It is unnecessary to conduct the testing if oxygen sensor is not adopted.
1. Set the Bag/mechanical ventilation switch to its position “Manual” ( ).

2. Take the oxygen sensor out of breathing system and wait for 2~3 minutes; measure the
indoor air, and verify that the measured O2 concentration [FiO2] is approximately 21%
3. Set the [Low Limit] of [FiO2] : In the user interface, select [Alarm] menu → Access
[ventilator] → Select [FiO2] [Low Limit] menu, and set the low alarm limit of the
parameter to 50%.
4. Observe the alarm prompt zone in the screen, make sure that [LowFiO2] is displayed.
5. Set the [Low Limit] of [FiO2] to a value lower than the current monitored value of [FiO2] ,
and make that the alarm of [LowFiO2] is cleared.
6. Re assemble the oxygen sensor into the breathing system.
7. Set the [High Limit] of O2 alarm: Select [Alarm] menu → Access [ventilator] → Select
[FiO2] [High Limit] enu, and set the high alarm limit of the parameter to 50%.
8. Connect the manual respiration leather bag to the manual respiration leather-bag port of
breathing system. Push the oxygen flush button to charge manual/independent leather bag,
and make sure that the O2 concentration [FiO2] measured by sensor is of approximately
100%.
9. Observe the physiologic alarm prompt zone in the screen, and make sure that [High FiO2]
is displayed.
10. Set the [High Limit] of [FiO2] alarm to 100%, and guarantee that [High FiO2] is cleared.
4.5.2 Test the Minute Volume (MV) Alarm

1. Make sure [Per-minute ventilation Amount] alarm is set to its ON mode.
2. Set the [Low Limit] alarm of [MV]: In the user interface, Select [Alarm] menu → access
[Ventilator] → Select [MV] [Low Limit] menu, and set the low alarm limit of the
parameter to 6.0L/min.
3. When the MV is lower than the low alarm limit, observe the alarm prompt zone in the
screen, and guarantee that [Low MV] is displayed.
4. Set the [High Limit] alarm of [MV] : In the user interface, select [Alarm] menu → Access
[ventilator] → Select [MV] [High Limit] menu, and set the high alarm limit of the
parameter to 9.0L/min.
5. When the MV is higher than the high alarm limit, observe the alarm prompt zone in the
screen, and guarantee that [High MV] is displayed.
4.5.3 Test the Apnea Alarm

1. Connect the manual respiration leather bag to the corresponding connector of the breathing
system.
4‐9

2. Set the Bag/Vent Control switch to “Manual” ( ).

3. Adjust the APL valve control knob such that it is just set to the position with the minimum
opening pressure.
4. Pinch the manual respiration leather bag, and guarantee that 1 complete respiratory cycle
takes place.
5. Stop pinching the manual respiration leather bag, wait for at least 30 seconds, and make
sure that [Apnea] alarm is displayed in the screen.
6. Pinch the manual respiration leather bag for several times, and make sure that the [Apnea]
alarm displayed in the screen disappears.
4.5.4 Test the Sustained Airway Pressure Alarm

1. Connect the manual respiration leather bag to the corresponding connector of the breathing
system.
2. Rotate the O2 flow control knob to the low limit.
3. Adjust the APL valve control knob, set the APL valve in position 30cmH2O.
4. Set the Manual / Mechanical Control switch to its position “Manually” ( )
5. Push and hold the oxygen flush button for approximately 15 seconds, and make sure that
[Continuous Pressure] alarm is displayed in the screen.
6. Turn on the patient-end outlet, and guarantee that [Continuous Pressure] alarm displayed
in the screen disappears.
4.5.5 Test the High Paw Alarm

2. In the user interface, Select [Alarm] menu → Access [ventilator] → Select [Ppeak] [High
Limit] menu, and set the alarm limits of the parameter to 0cmH2O ( [Low Limit] ) and
5cmH2O ( [High Limit] ).
3. Guarantee that [High Paw] is displayed in the screen.
4. Set the [High Limit] of gas channel peak pressure to 40cmH2O.
5. Guarantee that [High Paw] displayed in the screen disappears.
4.5.6 Test the Low Paw Alarm

1. Set the Manual / Mechanical Control switch to its position “Mechanical Control “( )”.
2. In the user interface, select [Alarm] menu → access [Ventilator] →Select [Ppeak] [High
limit] menu, and set the [Low Limit] alarm limit of the parameter to 2cmH2O.
3. Remove the manual respiration leather-bag from the patient-end port of wye fitting.
4. Wait for 20 seconds, observe the alarm prompt zone in the screen, and make sure that [Low
Paw] alarm is displayed in the screen.
5. Connect the manual respiration leather bag to manual respiration leather-bag port on the
breathing system.
6. Guarantee that [Low Paw] displayed in the screen disappears.
4‐10

4.5.7 Test the CO2 Monitor Alarm

1. Refer to “Chapter 7 Physiologic Alarms and Technical Alarms”.
2. Connect a carbon dioxide gas sampler to a CO2 analyzer.
3. Select [Alarm] menu → access [CO2] → Select the [High Limit] alarm menu of [FiCO2]
and [ETCO2], and set the alarm [High Limit] to 20 mmHg.
4. Make sure that the alarm [High FiCO2] / [High EtCO2] are displayed on the screen when the
concentration of inspired CO2 / expiratory-end CO2 are higher than the alarm limit respectively.
5. Set the [Low Limit] menu of [FiCO2] [ETCO2] alarms of [CO2] to 10 mmHg.
6. Set the [Low Limit] of CO2 to a value higher than the standard gas concentration.
7. Make sure that the alarms [Low FiCO2] / [Low EtCO2] are displayed on the screen when the
concentration of FiCO2/EtCO2 are lower than the alarm limit respectively.
4.6 Breathing System Testing

Warning
 Foreign objects remaining inside the breathing system may block up the gas flowing to the
patient, and may result in a casualty accident. Make sure that no testing plugs or other
foreign objects exist inside the breathing system.
 Breathing system shall be equipped with a respiration machine conforming to ISO 8835-5 and
YY 0635.4.
1. Make sure that the breathing system is connected properly and is kept in good order and
condition.
Once the breathing system is disconnected, the anesthesia machine may give an alarm “No
Breathing System”.
2. Make sure that the check valves in the breathing system work fine.
 If the Inspiratory check valve (unidirectional valve) is turned on during inspiration and is
transiently turned on when expiration begins, the Inspiratory check valve (unidirectional valve)
works fine.
 If the Expiratory check valve (unidirectional valve) is turned on during expiration and is transiently
turned on when inspiration begins, the Expiratory check valve (unidirectional valve) works fine.
4.6.1 Bellows Leak Tightness Testing

1. Set the system to its standby mode.
2. Set the Bag/mechanical ventilation switch to its position “Mechanical Control” ( ).
4‐11

3. Turn all flow control knobs to set to all gas flows to the minimum values.
4. Choke up the patient-end outlet, and shut down the breathing system.
5. Push the quick oxygen charging button to charge the bellows such that the folded sack of
bellows rises to the top end.
6. Make sure that the pressure indicated in the gas channel manometer may not exceed
15cmH2O.
7. The folded sack of bellows shall not drop. If yes, gas leak exists in the bellows. Reassemble
the bellows.
4.6.2 Breathing System Leak Test in Mechanical Ventilation Mode

Caution
 System leak testing includes the leak testing of anesthesia breathing system and anesthesia
ventilator.
 System gas leak testing must be conducted in its standby mode.
 To conduct system gas leak testing, make sure that the breathing system is connected
correctly, and the respiratory pipelines are kept in good order and condition.
Gas leak testing may be conducted as per the following procedures:

1. Make sure that the system is already set to its standby mode; Otherwise, push the standby
key to access [Standby] interface.
2. Make sure that the gas supply pressure is adequate.
3. Set the Bag/vent Control switch to its position “Mechanical Control” ( ).
4. Insert the Y-piece of corrugated pipe to the leak testing plug of breathing system to block up
the gas outlet of Y-piece.
5. Turn the flow control knob to turn off the O2, N2O and air flow completely.
6. Push the oxygen flush button such that the folded sack of bellows rises to the top end.
7. Select [Leak Test] menu → [Leak in vent mode] .
8. Push the [Start] button. The system begins respiratory-system gas leak detection and
displays simultaneously the prompting message: [Testing is Performing] .
9. If the system passes the detection, it displays a prompting message: [Leak rate PASS] .
Otherwise, it displays a prompting message: [Leak rate FAIL] . In such a case, check the
breathing system for correct connection, and check the pipelines for good condition. If no
problem exists, conduct leak detection over again.
Caution
4‐12

 Gas leak testing in progress may be terminated if [Stop] button is pushed during gas leak
testing. That does not mean the system gas leak testing fails, only that the current testing
gets invalid.
 If gas leak testing fails, check all possible sources of gas leak such as bellows, breathing system
pipeline, Canister (carbon dioxide absorbent)source and their connectors for good
condition or correct connection. During the check of CO2, absorber check the seal
components of Canister (carbon dioxide absorbent)for attached granules of CO2 absorbent,
and remove them if any.
 If leaks exist in the breathing system, do not use the equipment. Contact in time the
equipment maintainers or After-service Department of the department.
4.6.3 Breathing System Leak Test in Manual Ventilation Mode

1. Guarantee that the system is already set to its standby mode; Otherwise, push the standby
key ( ) to access [Standby] interface.
breathing system.
4. Adjust the APL valve control knob such that the APL valve is set to its maximum status
(position of 75cmH2O).
5. Turn the flow control knob to turn off the O2, N2O and air flow completely.
6. Insert the Y-piece of corrugated pipe into the leak testing plug of Manual/Independent
leather-bag port to block up the gas outlet of Y-piece.
7. Push the oxygen flush button to allow the value indicated by the gas channel manometer
rise to approximately 30cmH2O.
8. Release the oxygen flush button, and select [Leak Test] menu → [Leak in bag mode] .
9. Push the [Start] button. The system begins manual circuit leak testing and displays
simultaneously the prompting message: [Testing is Performing] .
10. If the equipment passes the testing, the system displays a prompting message [Leak rate
PASS] .Otherwise, it displays a prompting message: [Leak rate FAIL] . In such a case,
check the breathing system for correct connection, and check the pipelines for good
condition. If no problem exists, conduct leak detection over again. If gas leak still exists,
contact the equipment maintenance personnel of After-service Department of the Company.
11. Leaks may also be verified by observing the readings indicated by the gas channel
manometer during testing. If the readings drop, gas leak exists.
4‐13

4.6.4 APL Valve Accuracy Testing

1. Make sure that the system is already set to its standby mode; Otherwise, push the standby
key ( ) to access [Standby] interface.
2. Set the Bag/vent Control switch to its position “Manual” ( ).
respiratory circuit.
4. Insert the Y-piece of corrugated pipe into the leak testing plug of Manual/Independent
leather-bag port to block up the gas outlet of Y-piece.
5. Adjust the APL valve control knob such that the APL valve pressure is set to 30cmH2O.
6. Push the oxygen flush button to fully charge the manual/independent leather bag.
7. Make sure that the readings indicated by gas channel manometer range from 20to
40cmH2O.
8. Adjust the APL valve control knob such that the opening pressure of APL valve is set to the
minimum value (position MIN).
9. Set the O2 flow to 3L/min, and turn off other gases.
10. Make sure that the reading indicated by the gas channel manometer is smaller than
5cmH2O.
11. Push the oxygen flush button, and make sure that the reading indicated by gas channel
manometer does not exceed 10cmH2O.
12. Turn the O2 flow control knob to set the O2 flow to the minimum, and verify that the
reading indicated by the gas channel manometer does not drop to below 0cmH2O.
4.6.5 Test respiration Check Valve

1. Visual observation: Check whether or not the flappers stay inside the flapper tray evenly
when the system is set to its off position.
2. Turn on the system.
4. Make sure that ACGO is already set to its non-ACGO mode
5. Set the Bag/mechanical ventilation switch to its position “Mechanical Control” ( ).
7. Check whether or not the respiration check valve performs circulation while it is closed and
opened. If the respiration check valve fails to perform circulation when it is closed and
opened, it is faulty.
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4.7 Ventilator Testing

Caution
 Ventilator shall be equipped with an anesthesia system conforming to IEC 60601-2-13 and
GB9706.29.
2. Make sure that the relevant parameters and alarm limits of ventilator are set up as per
suitable clinical levels. For specific settings, refer to the chapter “14.10 Principle and
Parameter Specifications of the Ventilator”.
3. Set the Bag/vent Control switch to its position “Mechanical Control”.
4. Make adjustment in mechanical control mode, and connect the manual leather bag to the
patient-end port;
5. Set the parameters like different tidal volumes, respiratory rates and inspiratory/expiratory
ratios of anesthesia machine. Observe the monitored value and set values of the anesthesia
machine, and check whether or not the actual tidal volumes of bellows hood of the
breathing system may meet the clinical requirements.
4.8 AGSS Transmission and Absorption System Testing

Assemble the AGSS properly as per5.8.2, Assemble the AGSS, and check whether or not the
floater is ascended and exceeds the scale mark MIN. If the floater moves with adhesion or the
floater is damaged, contact the manufacturer for maintenance.
Caution
 Do not choke up the pressure compensation port of AGSS during the check.
If the floater cannot be ascended, possible causes include the following:
1. Floater adhesion. Turn the AGSS upside down, and check whether or not the floater may
travel up and Down freely.
2. Floater rises slowly. Filtering net is possibly choked up. Contact the manufacturer for
checks and maintenance.
3. Effluent gas treatment system does not work or the degassing flow rate is lower than
50L/min i.e. the normal-work flow rate of AGSS. Contact the manufacturer for checks and
maintenance.
4‐15

4.8.1 Leakage Test Conducted to the Connector of the AGSS and the
Exhaust Gas Outlet of Anesthesia Machine

1. Open the rear cover of the sheet metal box at the exhaust gas outlet. Remove the connector of the
internal corrugated tube and air‐capacitor.
2. Connect the tubing sets to be tested onto the inlet of air‐capacitor. Connect the pressure gage
well.
3. Remove the corrugated tube connected on the AGSS, and then block this port so that the
corrugated tube can be connected onto the exhaust gas outlet.
4. Ventilate 10 ± 0.5ml of air per minute into the tubing sets to be tested. The leakage amount shall
be no more than 100 ml/min in the transmission and receiving systems.
5. If the leakage amount exceeds the above value, please reconnect the tubing sets of the exhaust
gas outlet, and then retest according to the above steps.

4‐16

Chapter 5 Installation and Connection
Warning
 If electrosurgery units are adopted, keep their harnesses away from the breathing system,
oxygen sensor and other components of the equipment, make sure that the standby
manual/independent equipment of anesthesia machine are ready for use, and guarantee
that masked simple respirator are available such that the electrosurgery units may not
interfere normal use of the ventilator. In addition, guarantee that all life supporting and
monitoring equipment may be correctly operated.
 If high frequency surgical equipment is adopted, antistatic or electroconductive face masks or

respiration hoses may cause heat injuries; therefore, never use antistatic or
electroconductive face masks or respiration hoses.
 The equipment shall be installed by engineers specified by the manufacturer.
 The equipment is provided with an effluent gas discharge port. The users shall keep an eye on
the treatment of respiratory residual gases to be discharged.
5.1 Assemble the Breathing System

Caution
 When equipment running is over, pay attention to the treatment of the breathing system, and
test the CO2 absorbent inside Canister (carbon dioxide absorbent)anaesthetics inside the
anesthesia vaporizer so as to guarantee normal running of the equipment.
 Please do not weigh down the manual support column by hands or by hanging other heavy
objects onto it.
 If the difference between reading indicated by the gas channel manometer and the parameter
value displayed in the screen is relatively bigger, contact the Company.

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 Breathing System Structure
11
10
13
9
8 14
7
6 15
5
4
3
2 1
17 18 19 20 21

16
1 Expiratory flow sensor or flow port adapter 12 Gasbag Support Arm

2 Canister (carbon dioxide absorbent) 13 Bag/mechanical ventilation switch
3 Canister release 14 Inspiratory check valve (unidirectional valve)
4 Manual drain valve 15 Inspiratory flow sensor or flow port adapter
5 Leak test plug 16 Circuit Lock Hook
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6 Respiratory tube hook 17 Pressure Sampling Port

7 Expiratory check valve (unidirectional 18 Waste Gas Outlet
valve)
8 APL (Adjustable Pressure Limiting) Valve 19 Fresh Gas Inlet
9 Pressure gauge (airway) 20 Driving Gas Inlet
10 Manual bag port 21 Guide Post Hole
11 Bellows assembly (mechanical ventilation)
 Circuit Switchover Piece Structure
7 6
8
1 2 3 4 5
1 Circuit Support Guide Post 5 Pressure Sampling Connector

2 Waste Gas Discharge Connector 6 CircuitDisassembling Button
3 Fresh Gas Connector 7 Manual/Mechanical Control Axle
4 Driving Gas Connector 8 Heater Sheet
5.1.1 Assemble the Breathing System

1. Align the guide post hole in the side of breathing system to the
guide post of switchover piece.

1

2. Push the breathing system into the switchover piece forcibly such
that the breathing system is connected to the switchover piece
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without gap. Verify that the breathing system is always locked up.

2

Warning
 When breathing system is assembled onto the circuit switchover piece, you must verify that
the breathing system is already locked up. If the breathing system is not locked up, it may
be separated from the switchover piece during operation, resulting in severe leak of fresh
gas and mismeasurement of tidal volumes.
Caution
 If it is very hard to push the breathing system in, check whether or not the nuts on the
downside of the breathing system are tightened. The nuts may get stuck on the top of AGSS
if they are not tightened.
 If it is very hard to push in or take out the breathing system, it is necessary to apply small
quantity of lubricating oil (du pont Krytox high-performance fluorine grease) onto the seal
rings of air passage ports of the circuit switchover piece.
5.1.2 Assemble the Manual Support Column

1 Assemble the screw‐down nut to the manual support column,
aligning the buckle on the support column to the buckle of the
breathing system connector, as shown in the right figure.

1

2 Assemble the manual support column connector to the
breathing system connector, as shown in the right figure.

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2
3 Tighten the screw-down nut clockwise, as shown in the right figure:
3

5.1.3 Assemble the Manual Respiration Leather Bag

1、Fit on the manual respiration leather bag upward, and screw it down to the manual sway brace.

1

5.1.4 Assemble the Bellows

1 Fit the last bottom coil of folded sack onto the bellows tray of the breathing system, as shown
in the figure below: To guarantee that the folded sack is tightly connected to the bellows tray,
check whether or not the folded sack is assembled properly as per the following procedures:
Push the oxygen flush“ ”, the folded sack shall be normally charged and gets upright.
 Folded Sack
 Bellows tray
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 Seal Component

①

②
③
2 Align the bayonet of bellows cover to the groove in the breathing system. Press downward the
bellows cover to the end. Hold the outer side of bellows cover by both hands, and screw down
it clockwise. Ensure the side indicated with scale marks faces the operator, as shown in the
right figure:
3 Please make sure the degree scale on the bellows faces

right ahead when tightening the bellows.
Warning
 Before assembling the bellows cover, check whether or not the seal components of breathing
system are normal. If any backing-out or warpage is found, assemble the seal components
properly before bellows cover is assembled.
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5.1.5 Assemble the Flow Sensor

 Keep in line the direction of arrow marked on the flow sensor and the direction of arrow
marked on the breathing system, allow the side with arrows to face upward, as shown in the
figure below:
1
 Align the flow sensor to the groove and insert it into the latter.
2
 Align the respiration connector and locknut to the flow sensor port. Tighten the respiration
port locknut clockwise.

3

Warning
 When flow sensor is assembled, tighten the respiration connector rotary-cap locknut;
otherwise flow sensor measurement may be disabled.
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5.1.6 Assemble the Respiration Hose and Y-piece

Caution
 To assemble the respiration hose, hold the connectors at both ends of the respiration hose so as
not damage the respiration hose.
1 Connect a filter to the Y-piece.
2 Assemble the expiratory hose and inspiratory hose onto the expiratory port and inspiratory
port on the breathing system respectively.
2
5.1.7 Assemble the Oxygen Sensor

Warning
 Before assembling the oxygen sensor, check the seal rings of oxygen sensor for good condition.
Replace the oxygen sensor with a new one if no seal rings exist or are damaged.
 Oxygen sensor must be assembled properly; otherwise gas leak may occur in the breathing
system.
1. Align the oxygen sensor to the oxygen sensor port “ ” on the breathing system, and insert it
into the port and assemble it securely.
2. Insert one end of oxygen sensor cable into the jack of oxygen sensor.
3. Insert the other end of oxygen sensor cable into corresponding oxygen sensor port “ ” on
the principal machine, as shown in the right figure:
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1

2

3
5.1.8 Assemble the Gas Channel Manometer

1. Before assembling the airway manometer, please check whether the slot is unlocked. If locked, press
the buckle to unlock the slot before proceeding to the next step.
2. Directly insert the gas channel manometer into the bayonet of CPC connector. The gas channel
manometer is securely assembled if a sound “De” is heard.
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5.2 Install the Canister (carbon dioxide absorbent)

Warning
 Please observe the following applied provisions for safety protection:
 Do not use the absorber with chloroform or trichloroethylene.
 Change absorbent frequently to prevent sedimentation of non-metabolic gas when the system
is not in use.
 Use of seasoned CO2 absorbent may endanger the patients. Proper preventive measures shall
be taken to guarantee that the CO2 absorbent inside the Canister (carbon dioxide
absorbent)may not get dry. All gas supplies shall be turned off every time operation of the
system is over.
 Do not use the absorber with chloroform or trichloroethylene.
 Disposable Canister (carbon dioxide absorbent)falls within sealed devices, and may not be
opened or refilled with CO2 absorbent.
 Do not allow your skin or eyes to be exposed to substance contained inside the CO2.absorber
In case skin or eyes are exposed to the substances, rinse the affected parts with fresh water
immediately, and take medical treatment.
 If anesthesia machine is not provided with BYPASS function, replacement of CO2 absorbent
during gas-feed might cause leakage in the breathing system.
 If the anesthesia machine is provided with Bypass function, be sure to assemble and lock up
the Canister (carbon dioxide absorbent)properly; Otherwise, the patient may inhale
repeatedly the carbon dioxide he gives off.
 If anesthesia machine is provided with BYPASS function, we strongly recommend that CO2
concentration monitor be adopted. The equipment may be connected to a CO2 analyzer
conforming to ISO21647 for monitoring the CO2 output concentration. The CO2 analyzer
to be adopted is not limited to MASIMO brand. For details of the operation guide and
precautions, see the attached specification sheets for attachments.
 To assemble a Canister (carbon dioxide absorbent)check the color of CO2 absorbent inside the
Canister (carbon dioxide absorbent)so as to determine whether or not to change the CO2
absorbent first.
 Every time a case is finished during operation, check the color of CO2 absorbent, and take
corresponding treatment measures. For details of changes in color of CO2 absorbent, refer
to the label attached on the package of CO2 absorbent. Color of the CO2 absorbent may
possibly restore to its original color during the period of time when it is not in use.
 Please take appropriate preventive measures to ensure that the CO2 absorbent inside may
absorber not get dry. All gas supplies shall be turned off in time every time the system
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running is over. If thoroughly dry CO2 absorbent is exposed to anaesthetics, it may release
carbon monoxide (CO), and its continuing in service may do harm to the patients. Replace
CO2 absorbent in time for the sake of safety of patients.
 Please clean CO2 absorber and replace the sponge of Canister (carbon dioxide
absorbent)regularly; Otherwise CO2 absorbent powder settled inside the Canister (carbon
dioxide absorbent)may access the breathing system.
 Please clean the Canister (carbon dioxide absorbent)port regularly. Otherwise the CO2
absorbent granules possibly attached on the port may lead to leakage in the breathing
system.
 To assemble the CO2 absorber, Check Canister (carbon dioxide absorbent)port strutting piece
and lock ring for attached CO2 absorbent granules. If any, remove the granules; otherwise
they might result in leakage in the breathing system.
Caution
 Gradual change in color of absorbent inside the absorber indicates that absorption of carbon
dioxide takes place. The change in color of absorbent is only a rough indication. It is
advisable to determine the time to replace the absorber by carbon dioxide concentration
monitoring.
 Discolored absorbent shall be discarded. If the said absorbent is laid aside for several hours, it
may restore its original color, and the users might therefore be misled.
 Prior to operating the product, read the specification sheets for absorber completely.
 The breathing system of anesthesia machine includes the self closed-circuitsystem and
non-closed- circuit system. The difference between them is that the former is equipped with
the Bypass function.
1 Check whether the CO2 absorber inlet, CO2 absorber holder

and seal ring are attached with absorbent granules or
powder. If any, please remove them. Thefilled CO2absorbent
cannot be higher than the “‐max‐” mark on the CO2
absorber..

1

2 Pinch the CO2 absorber lock catch with the left hand and
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rotate it rightward to unlock the assembling bracket , as

shown in the right figure.

2

3 Align the CO2 absorber to the mounting slot in the assembling
bracket, as shown in the right figure.

3

4 Push the CO2 absorber to the end of the assembling slot until
it is fixed, aligning the botton line of the right part to the
position as shown in the right figure:

4

5 Lift up the handle of the bracket until it is locked, as shown in
the right figure:

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5

6 The CO2 absorber has been assembled successfully, as shown
in the right figure:

5.3 Replace the Canister (carbon dioxide absorbent)

As the breathing system includes the closed-circuit system with the Bypass structure, so the gas
won’t leak out to the atmospheric air during the process of replacing CO2 absorber. But be sure to
timely replace the CO2 absorbent and mout the CO2 absorber to prevent CO2retention
1. Push the release gear of CO2 absorber aside to remove the CO2 absorber, as shown in the figure
below.
2. The filled CO2absorbent cannot be higher than the “-max-” mark on the CO2 absorber. Check
whether the CO2 absorber holder, seal ring and the inlet are attached with CO2absorbent granules
or powder. If any, please remove them. Push the CO2 absorber to the end of the assembling slot
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until it is fixed , aligning the botton line of the right part to the position as shown in the
right figure:
3. Lift up the handle of the bracket until it is locked, as shown in the right figure:
5.4 Replace CO2 Absorbent

Caution
 Gradual change in color of absorbent inside the absorber indicates that absorption of carbon
dioxide takes place. The change in color of absorbent is only a rough indication. It is
advisable to determine whether or not to replace theabsorber by carbon dioxide monitor.
 Discolored absorbent shall be discarded as per local correlative laws and Regulations or waste
disposal system of the hospital. If the said absorbent is laid aside for several hours, it may
restore its original color, and the users might therefore be misled. To avoid the misleading
effect, we suggest that CO2 absorbent shall be replaced by new one prior to each operation,
or carbon dioxide monitor may be adopted.
 We recommend that “Medisorb TM” CO2 absorbent be adopted.
1. When you remove CO2 absorber, please refer to the inverseprocess of CO2absorber assembling in
the section 5.2 of this chapter.
2. Pinch the lock catch of the CO2 absorber with your left hand and rotate it rightward, as shown in
the flag, open the assembling bracket and take it out with your right hand .
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3. Take out the discolored CO2 absorbent.

4. Fill the new CO2 absorbent into the CO2absorber along the inside periphery to prevent absorbent
entering the ventilation hole of the holder, otherwise, it may result in increased air resistance.
5. Check whether the CO2 absorber inlet, CO2 absorber holder and seal ring are attached with
CO2absorber granules or powder. If any, please remove it. The placed CO2 absorbent cannot be
more than the “-max-” mark on the CO2absorber.
6. Please refer to the procedure in the section 5.2 of this chapter to reassemble the CO2absorber
Warning
 To remount Canister (carbon dioxide absorbent)after replacement of Canister (carbon dioxide
absorbent), be sure to check Canister (carbon dioxide absorbent)for locking so as to ensure
proper assembling.
Caution
 The level of CO2 absorbent must not exceed the “max” flag marked on the Canister (carbon
dioxide absorbent)
5.5 Connection of Gas Supplies

The anesthesia machine is provided with 2 types of ports for pipeline gas supplies (O2, N2O
and AIR) and gas cylinder (O2 and N2O).
Four (4) types of configuration are provided for pipeline gas supplies:
 O2
 O2 and N2O
 O2 and AIR
 O2, N2O and AIR
Warning
 Only medical-use gas supplies are allowed to adopt. Other types of gas supplies might contain
water, oil or other contaminants.
 If the central gas supply system develops a fault, 1 or more equipment connected to it may
quit work. In such a case, just turn on the standby cylinders to guarantee normal work of
the anesthesia machine.
 When gas supplies are turned off, pressure still exists inside the pipelines. Therefore, release
the gases from the pipelines before you unplug the gas pipes.
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5.5.1 Pipeline Inlets

The anesthesia machine may be provided with ports for 3 types of pipeline gas supplies
namely O2, N2O and AIR. The gas supply hoses are marked with different colors, and the
hose connectors of different types cannot be interchanged. The steps to connect gas supply
hoses to the anesthesia machine are given below:
1. To connect the gas supply pipeline, check whether or not the seal rings of connectors
for good condition.If the seal rings are damaged, the pipeline cannot be used, and seal
rings must be replaced; otherwise gas leak may take place.
2. Align and insert the gas supply hoses and connectors into the gas-supply inlet ports on
the back of anesthesia machine.
3. Ensure that the gas supply hoses are securely connected to the gas supply inlets, and
tighten the hose nuts by hand.
Caution
 The air supply hoses shall meet the standards of ISO 5359 and YY/T 0799.
 The hose connectors shall meet the standards of ISO 9170-1 and YY 0801.1.
5.5.2 Exhaust Emission

The exhaust emission assembly is located on the left side of the workbench and is provided
with 2 exhaust ports i.e. exhaust emission hole (AGSS) and the gas vent for positive end
exipiratory pressure (PEEP) generating device.
For exhaust emission, the following shall be adopted:
1. PEEP exhaust port, which may directly discharge effluent gases indoors.
2. Outside diameter of AGSS connector is 30mm, with a taper of 1:20. Please connect
anesthesia gas cleaning device or effluent gas treatment system.
Warning
 The PEEP exhaust port may continuously discharge small quantity of oxygen. Never choke up
the outlet; otherwise the anesthesia ventilator cannot work.
 Prior to an operation, anesthesia machine shall be equipped with an anesthesia gas cleaning
system conforming to ISO 8835-3 and YY 0635.2 to clean the air inside the operating room.
 If your anesthesia machine is not equipped with active AGSS, please do not connect the
exhaust emission port of your anesthesia machine to the active effluent gas treatment
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system of the hospital.
5.6 Assemble the Anesthesia Vaporizer

Anesthesia machineis applicable to anesthesia vaporizer Penlon series and anesthesia vaporizer
Dräger series of Selectatec® (registered trade mark Ohmeda) fixation and interlocking
mechanism for non-flammable anesthesia gas.
Warning
 If the equipment clashes against its vaporizer, their performance may be degraded. Please use
vaporizer that assorted with the equipment.
Caution
 For details of vaporizer assembling/running, refer to instruction manual of corresponding
vaporizers.
5.6.1 Assemble the Anesthesia Vaporizer

In the following assembling steps, anesthesia evaporator Dräger Vapor 2000 is given as an
example:
1. Hang the anesthesia vaporizer onto the anesthesia vaporizer soleplate of the anesthesia
machine, and ensure that the anesthesia vaporizer completely fits the soleplate free of gap,
as shown in the figure below:
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2. Turn clockwise the locking bar to fix the anesthesia vaporizer onto the soleplate, as shown in
the figure below:
3. Ensure that top of the anesthesia vaporizer is horizontal; Otherwise the anesthesia
vaporizer hall be removed and re assembled.
4. To reassemble it, lift up each anesthesia vaporizer vertically (90 degrees) such that it is
separated from the soleplate, but do not pull it forward. Be careful not to allow the
anesthesia vaporizer to rotate on the soleplate.
5. When the anesthesia vaporizer is separated from the soleplate, reassemble the vaporizer
and perform steps 1~3. If the anesthesia vaporizer cannot be positioned horizontally on
the soleplate, do not use the system.
6. Try to turn on one or more anesthesia vaporizers.
7. Test each possible combination. If one or more anesthesia vaporizers can be turned on
simultaneously, remove and reassemble the anesthesia , vaporizer and finish steps 1 to 6.
5.6.2 Replenish Anaesthetics

For replenishing mode of anaesthetics, please refer to specification sheets attached to the
anesthesia vaporizers
Warning
 Ensure that anaesthetics are replenished correctly. Anaesthetic names are already indicated on
the vaporizers, and they are also marked with different colors. If anaesthetics are
incorrectly replenished, the actual output concentration of anaesthetics may be changed.
5.6.3 Discharge Anaesthetics

For discharging mode of anaesthetics, please refer to specification sheets attached to the
anesthesia evaporators.
Warning
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 Anaesthetic liquor discharged out of the evaporators must not be reused, and it shall be
disposed as hazardous chemicals.
 Please indicate on the bottles contained the discharged anaesthetic as follows: used
anaesthetics.
5.7 Assemble Plug-in Module
5.7.1 AssembleCO2 Module

1. Insert the module into the slot.
2. Push the module into the place until the lever at its
bottom gives a “Click” sound, indicating that the
module is fixed properly.
3. The indicator light on the module turns on, indicating

the module is installed properly.
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4. Insert the sampling line into the sampling port.
5. Insert one end of the exhaust tube into the exhaust

outlet on the module, and rotate it clockwise to tighten
it.
6. Insert the other end of the exhaust tube into the exhaust
inlet on the anesthesia machine. A “Click” sound
indicates the tube is installed in place.
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5.7.2 Assemble SidestreamAG Module

Please refer to content with corresponding of this section of " 5.7.1 Assemble CO2 Module" part.
5.7.3 Disassemble CO2 Module

1. Pull off the sampling line, as shown in the right figure.
1

2. Press down the clip at the exhaust outlet on the anesthesia machine to pop out the exhaust tube, and
then remove the tube, as shown in the tight figure.
2
3. Rotate the tightening knob of the exhaust tube anticlockwise to release the knob, and then pull off the
tube.
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3
4. Push up the lever at the bottom of the module, and pull out the module.
4
5.7.4 Disassemble AG Module

Please refer to content with corresponding of this section of "5.7.3Disassemble CO2 module" part.

5.8 AGSS Transmission and Absorption System
Warning
 AGSS transmission and absorption system shall work with a breathing system conforming to
YY 0635.1 and ISO 8835-2.
 Processing system shall be A H-type low-vacuum high-flow vacuum suction system.
5.8.1 Structural Composition of AGSS

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1
2 7
6
3
5
4
No. Notes
1 Waste gas exhaust nozzle connector
2 AGSS effluent gases outlet
3 Outer cone connector for hose of transmission system
4 Pressure Compensation Port
5 Main body of AGSS system
6 Floater (red)
7 Flow regulation knob
5.8.2 Assemble the AGSS

1 Assemble the waste gas exhaust nozzle connector to the
gas outlet of absorption system：
1
2 Hang a AGSS system onto the AGSS bracket.
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2
3 Connect the hose of transmission system to the gas outlet of absorption system.
3
4 Connect the 30mm outer cone connector for hose of transmission system to the air inlet of
AGSS system.
4
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5 Connect the AGSS effluent gases outlet to the effluent gas treatment system of the hospital
through AGSS active blow off pipe.

5

Caution
 Do not block the pressure compensation port during the process of assembling and using
AGSS.
 Prior to transportation or movement of the anesthesia
5.8.3 Effluent gas treatment system
1 AGSS transmission and absorption system is 1H-type high-flow low-vacuum model, and
conforms to Standard ISO 8835-3 and YY 0635.2The adjustable range of degassing flow rates
of the AGSS transmission and absorption system is50 ~80 L/min.
2 Prior to use, verify that the effluent gas treatment system is a high-flow rate processing system,
and may reach corresponding ranges of flow rates.
3 Prior to use, verify that connectors of the effluent gas treatment system are BS 6834-1987
standard connectors.
Caution
 During testing, do not choke up the pressure compensation port of the AGSS transmission and
absorption system.
Warning
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 The AGSS transmission and absorption system is not applicable to inflammable anesthesia
gases.
 If the line between effluent gas treatment system and AGSS is clogged, the pumping flow of
effluent gas treatment system is deficient, exhaust gas from the expiratory system exceeds
the tidal volume 1L specified in ISO 8835-3 and YY 0635.2 or exceeds the required
semi-sine gas flow of 20 times/minute, or the effluent gas treatment system fails to work, gas
inside the AGSS may exceed 100 mL/min and spill over into the atmosphere. In such a case,
it is inadvisable to use the AGSS.
5.9 O2 Dual Channel Inlet Fitting

1. Connect the inlet fittings and oxygen pipe connectors.

1

2. Tighten the nut.

2

3. Assemble finished.
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Chapter 6 Alarm
6.1 Overview
Alarms indicate the audible and visual prompts given by the anesthesia machine to the medical
care personnel in case the patients who are maintained by the anesthesia machine show
exceptional changes in vital signs or the anesthesia machine develops a fault such that the
anesthesia machine cannot be smoothly run for the patients.
Caution
 When the equipment is turned on, the system may check the warning tones and alarm lamp
functions for normal condition. If yes, the equipment may give a sound “Beep”, and the
alarm lamp blinks once in yellow and red each. If the tones and alarm lamp functions are
abnormal, do not use the equipment. Please contact the Company immediatley.
 In case multiple different alarms occur simultaneously, the equipment will give audible and
visual alarms as per the alarm of the highest level among them.
 User shall set the alarm volume and alarm limits as per actual conditions of the patients. Do
not monitor the patients only as per the audible alarm system. If the warning tone is
adjusted to a lower volume, the patients may be endangered. User shall pay close attention
to actual clinical status of the patients.
 Information such as physiological parameters and alarms displayed in the display screen of
the equipment are designed for clinicians’ reference, and must not be directly considered as
references for clinical treatment.
6.1.1 Alarm Types

Alarms given by the anesthesia machine may be divided into physiologic alarms, technical
alarms and prompting messages as per the properties of alarms.
1 Physiologic Alarms
Physiologic alarms are usually given in case a certain physiological parameter of patient
exceeds the preset High/Low alarm limits or physiologic exception of the patient takes
place. The alarm messages of physiologic alarms are displayed in the physiologic alarm
zone in the upper part of the screen.
2 Technical Alarms
Technical alarms, which are also known as system error messages, indicate the alarms
triggered incase a certain system function cannot run normally or the monitoring results
are distorted due to misoperation or system malfunction. Alarm messages of technical
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alarms are displayed in the technical alarm zone in the upper part of the screen.
3 Prompting Messages
Strictly speaking, prompting messages do not fall within alarms. Prompting messages
indicate the massage (except for physiologic alarms and technical alarms) displayed by
the anesthesia machine about system state, and these messages usually do not relate to the
vital signs of patients. The prompting messages are displayed in the system prompting
message zone.
6.1.2 Alarm Levels

As per the severity of alarms, physiologic alarms given by the anesthesia machine may be
divided into high level alarms, medium level alarms, and low level alarms.
1 High Level Alarms
Patient remains in critical condition with possible life risk, and shall be subjected to
emergency treatment immediately.
2 Medium Level Alarms
Physiologic physical sign of patient gets abnormal, and corresponding measures shall be
taken or treatment shall be conducted immediately.
3 Low Level Alarms
Physiologic physical sign of patient gets abnormal, and corresponding measures may
possibly be taken or treatment may possibly be conducted.
Levels of all technical alarms and some physiologic alarms are already preset before
factory leaving of the anesthesia machines, and cannot be modified by the users. Levels of
some physiologic alarms may be modified.
6.2 Alarm Modes

In case an alarm occurs, the anesthesia machine may prompt the user by audible and visual
alarms listed below:
 Visual alarms
 Audible alarms
 Alarm messages
 Parameter flickering
Of which, the alarm levels of visual alarms, audible alarms and alarm messages are identified
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in different ways respectively.
6.2.1 Visual Alarm

In case an alarm occurs, alarm indicator lamp may prompt alarms of different levels by
different colors and flicker frequencies.
 High level alarms: red, high flicker frequency.
 Medium level alarms: yellow, medium flicker frequency.
 Low level alarms: yellow, constantly going on, without flickering.
6.2.2 Audible Alarms

Audible alarm indicates that In case an alarm occurs, anesthesia machine may prompt alarms
of different levels by different sound characteristics.
 High level alarms: Beep-Beep-Beep-Beep-Beep-----Beep-Beep-Beep-Beep-Beep.
 Medium level alarm: Beep-Beep-Beep.
 Low level alarms: Beep.
6.2.3 Alarm Messages

Alarm message indicates that corresponding alarm message may be displayed in the
physiologic alarm zone or technical alarm zone of anesthesia machine in case an alarm
occurs. System adopts different ground color to differentiate levels of alarm messages.
 High level alarms: Red
 Medium level alarm: yellow
 Low level alarm: yellow
The following marks are positioned before alarm messages to differentiate level alarm
messages:
 High level alarms: !!!
 Medium level alarm: !!
 Low level alarm: !
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6.2.4 Alarm Parameter Flickering

In case a parameter alarm occurs, the parameter may flickers at a frequency of once/second.
6.2.5 Alarm Status Icons

In addition to the above alarm modes, the following alarm status icons may also be displayed
in the screen to indicate different alarm statuses.
: The icon indicates that alarm sound is muted.
6.3 Set the Alarm Volume

 In the user interface, select [Alarm] → Access [Alarm Volume] menu: 1~8. “1” indicates
the minimum volume, and “8” indicates the maximum volume.
Warning
 When running the equipment, you cannot just depend upon audible alarms. If the warning
tone is adjusted to a lower volume, the patients may be endangered. User shall pay close
attention to actual clinical status of the patients.
6.4 Set the Alarm Limits

Caution
 When parameter values is higher than [High limit] or lower than [low limit] , an alarm may be
triggered.
 When running the equipment, check regularly whether or not the parameter alarm limits are
set to suitable values. Set up the [High limit] and [low limit] as per clinical requirements. If
the settings are beyond the valid range, the alarm system may be void.
6.4.1 Set the Alarm Limits of Ventilator

1. In the user interface, select [Alarm] menu → [ventilator] .
6‐4

2. In the [Ventilator] alarm interface, set one by one the alarm [High Limit] and [Low limit]
of parameters like [MV] , [Ppeak] , [FiO2] and [T V] .
3. Or select the default High/Low alarm limits by [Load Default Alarm Limit].
Fig. 6- 1 Set the Ventilator’s Alarms
Range of High/Low alarm limits:
High Default alarm

Name Low limit Unit Step size
Limit limit
1(low limit)
MV 2~100 0~ (High limit-2) L/min 2
10(high limit)
10(low limit)
Ppeak 2~100 0~ (High limit-2) cmH2O 2
50(high limit)
21(low limit)
FiO2 20~100 18~ (High limit-2) % 1
103(high limit)
5(low limit)
TV 5~1600 0~ (High limit-5) mL 5
1000(high limit)
6‐5

Warning
 If an alarm is cleared in manual mode, alarms such per-minute ventilation amount and
expiratory tidal volume will not be triggered.
 Alarm settings can be saved 30 seconds before or after shutdown of the machine.
6.4.2 Set the CO2 Alarm Limits
1. In the user interface, select [Alarm] menu → [CO2] .
2. In the [CO2] alarm interface, set the [High Limit] and [Low Limit] for [FiCO2] and
[ETCO2] parameter alarms, as shown in the figure below:
Fig. 6- 2Set the Carbon Dioxide Alarms
Range of High/Low Alarm Limits:
Default alarm
Name High limit Low limit Unit Step size Remarks
limit
0~ (High 15(low limit) mmH

FiCO2 2~76 1 N/A
limit-1) 50(high limit) g
0~ (High 0(low limit) mmH

EtCO2 2~76 1 N/A
limit-1) 4(high limit) g
6‐6

6.4.3 Setting AG Warning Limits

1. Choose the shortcut key [Alarm] → [AG] on the User Interface.
2. Set the [High Limit] and [Low Limit] of the parameters of [FiN2O] , [EtN2O] , [FiEnf] and [EtEnf] on
the [AG] Alarm Interface. See the following table:

Fig. 6‐ 3Setting Anaesthetic Gas Warning
Scope of the High Limit and Low Limit of Warning:
Step
Name High Limit of Warning Low Limit of Warning Unit Remarks
Length
FiCO2 (Low Limit +2)~76 0~(High Limit ‐2) mmHg 1 None
EtCO2 (Low Limit +2)~76 0.0~(High Limit ‐2) mmHg 1 None
FiN2O (Low Limit +2)~100 0.0~(High Limit ‐2) % 1 None
EtN2O (Low Limit +2)~100 0.0~(High Limit ‐2) % 1 None
Inhalation of AA(Hal, Enf,
(Low Limit +0.2)~5.0 0.0~(High Limit ‐0.2) % 0.1 None
Iso Sev and Des)
Exhalation of AA(Hal, Enf,
(Low Limit +0.2)~5.0 0.0~(High Limit ‐0.2) % 0.1 None
Iso Sev and Des)
6.5 Set the Alarm Levels

Set the CO2 alarm levels: select [Alarm] menu → [CO2] → [Alarm Level]. CO2 alarm levels
may be set as [High], [Medium] or [Low].
6‐7

Caution
 In the equipment, only the levels of parameter alarms of CO2 module may be set, and the
levels of all other parameter alarms are permanently preset by the manufacturer.
6.6 Set the Cardio-pulmonary Bypass Alarm

In non-automatic circuit mode:
1. Select [Alarm] menu → [Ventilator>>].
2. Set the [Cardiac Bypass] to [ON] or [OFF]. If [Cardiac Bypass] is set to [ON], system
prompts [Cardiac Bypass]
In mechanical ventilation mode, system set the [Cardiac Bypass] to [OFF] automatically, and
the user cannot modify it.
Warning
 During [Cardiac Bypass] is set to [ON] , part of the physiologic alarm messages may not be
triggered; therefore, the setting shall be applied cautiously. The physiologic alarms include:
Apnea, Apnea>2min, Low Paw, High Tvexp, Low TVexp, High MV, Low MV.
6.7 Alarm Mute
6.7.1 Set the Alarm Mute

Push the alarm mute key to set the system to alarm mute status, namely all warning tones of
the system are shielded, and “ ” icon and 120 s counting-down may be displayed in the
upper right corner of the screen.
Caution
 In the alarm mute status, all alarm modes works normally except for audible alarm.
 In alarm mute status, system may automatically end the current alarm mute status and
recover the audible alarm once new technical or physiologic alarms are generated.
 Once 120s counting down expires, system releases the current alarm mute status and recovers
the audible alarm.
 If [No O2 Pressure] alarm is generated while the system is already set to alarm mute status,
system will automatically cancel the alarm mute, and enter into its high-level technical
alarm mode. Here, the alarm mute key is disabled. When [No O2 Pressure] alarm
6‐8

disappears, the functions of alarm mute key may get right.
6.7.2 Cancel the Alarm Mute

If the alarm mute key is pushed or a new alarm is generated in alarm mute status, system may
release the current alarm mute status and recover audible alarm, and the alarm mute icon and
120s counting down displayed in upper right corner of the screen disappear simultaneously.
6.8 Alarm Countermeasures

If anesthesia machine gives an alarm, take corresponding measures as per the following steps:
1. Check the status of patients.
2. Verify the alarming parameter or alarm types.
3. Find out the causes of the alarm.
4. Eliminate the causes of alarm.
5. Check whether or not the alarm is eliminated.
For specific treatment measures for each alarm, refer to “Chapter 7 Physiologic Alarms and
Technical Alarms”.
6.9 Types of Detection Alarm System
There are 3 types of alarm systems, i.e. physiological alarm, technological alarm and prompt
message respectively. It can be seen from the conditions of the “Light Alarm”, “Voice Alarm”,
“Parameter Flash” and “Alarm Information” that whether the alarm system is in good condition or
not. For example:
1. Make preparations according to the “Measure Steps and Examination” in Chapter CO2 ,
and enter the [CO2] Alarm Interface to set [High Limit] and [Low Limit] of the
parameters of [FiCO2] , [EtCO2] as 15 mmHg and 6 mmHg respectively.
2. To choose the shortcut key [Alarm] →enter the menu of [Sound] and [Indicate Sound
Volume] , and set the volume at Grade “1~8” on the User Interface.
3. When the measure values exceed the maximum and minimum of alarm, enter the shortcut
key [Alarm] → [CO2] → [Alarm Level] , and set the [Alarm Level] at [High Limit] ,
[Medium] and [Low Limit] to observe the changes of voice, light and parameter flash of
the equipment. See the contents of “Voice Alarm, Alarm Information and Parameter Flash
6‐9

of Alarm” in this chapter for details. Meanwhile, it indicates that CO2 is too high or too low
in the message box of physiological alarm.
4. If it warns under the normal circumstance which the parameter surpasses the maximum and
minimum of alarm, the equipment will response with alarms of “light, voice, parameter
flash and information” , and the average delay of alarm does not exceed 5 seconds.
5. Pull out the sampling pipe of CO2 from the anesthesia machine, and the following message
prompts out in the message box of technological alarm: Without Adsorption Tube.
Attention
 When the alarm system gives several alarms at the same time, the system preferentially gives
high level warning with light and voice.
6‐10

Chapter 7 Physiologic Alarms and Technical Alarms

Some essential physiologic and technical alarm messages are listed in this chapter, however, some alarm
messages are not necessarily listed.
Caution: In this chapter, L indicates default alarm level, H indicates high level, M indicates medium level, and
L indicates low level.
Corresponding countermeasures are listed for each alarm message. In case the problem still exists after
operation is performed as per the countermeasure, contact the maintainers.
1 Physiologic Alarms
Alarm
Alarm messages Causes and countermeasures
level
Two (2) triggering conditions are satisfied simultaneously:
1. Gas channel pressure is continuously lower than (PEEP +3) cmH2O
(exceeding 30 seconds).
Apnea M 2. Expiratory tidal volume is always lower than 10ml (exceeding 30
seconds).
Increase the set values of tidal volume and respiratory frequency, or set
it to Manual/Independent mode.
No respiration takes place within the latest 120 seconds. Check status
Apnea>2min H of the patient. Use Manual/Independent mode to aid the patient to
breathe. Check whether or not any pipeline drops out.
Gas channel peak pressure Ppeak is higher than the set value of high
High Paw H alarm limit. Reduce the set value of tidal volume, or increase the set
value of upper Paw alarm limit.
Gas channel peak pressure Ppeak is lower than the set value of lower
Low Paw H Paw alarm limit (lasting for 20 seconds). Increase the set value of tidal
volume, or reduce the set value of upper Paw alarm limit.
If Paw is higher than Plimit, increase the Plimit or reduce the preset
Pressure Limiting L
tidal volume, or adjust downwards the respiratory rate.
FiO2 is higher than preset high alarm limit. Reduce fresh‐gas oxygen
High FiO2 M
flow or increase the high alarm limit.
FiO2 is lower than the preset low alarm limit. Increase fresh‐gas oxygen
Low FiO2 H
flow or reduce the low alarm limit.
High TVexp M Expiratory Tidal Volume is higher than high alarm limit. After adjusting
the respiration settings, this alarm will be void within 9 initial
respiratory cycles. Reduce the preset tidal volume or increase the high
alarm limit.
Low TVexp M Expiratory Tidal Volume is lower than low alarm limit. After adjusting
the respiration settings, the alarm will be void within 9 initial
respiratory cycles. Increase the preset tidal volume or lower the low
alarm limit.
TV Less Than M Under the VCV mode, the expiratory tidal volume within 5 continuous
7‐1

Alarm
Alarm messages Causes and countermeasures
level
Minimum Set Value respiratory is lower than the low limit. Please check the condition of
patient, airway connection and flow sensor.
MV is higher than the preset high alarm limit. If switch over the
ventilation mode or adjust the parameter setting of ventilator, the
alarm item will be displayed within 9 respiratory cycles or 1 minute
High MV M
after the setting is made (whichever is relatively lower). Reduce the
preset tidal volume, reduce respiratory frequency, or increase the high
alarm limit.
MV is lower than the preset low alarm limit. If switch over the
ventilation mode or adjust the parameter setting of ventilator, the
alarm item will be displayed within 9 respiratory cycles or 1 minute
Low MV M
after the setting is made (whichever is relatively lower). Increase the
preset tidal volume, increase respiratory frequency, or reduce the low
alarm limit.
Pressure is 10cmH2O lower than the atmosphere. Check whether or
not the patient is conducting autonomous respiration. Increase the
Negative Pressure H fresh gas flow. Check whether or not there is high‐velocity air flow
through the residue gas scavenging system. If yes, check the negative
pressure relief valve on the receiver.
Breathing suffocate M Check the patient breathe
Continuted high H Paw in the breathing circuit>For high airway pressure alarm line is
airway pressure limited to 15 seconds。
2 Technical Alarms

Alarm messages Alarm level Causes and countermeasures
Pressure Sensor Patient‐end pressure monitoring gets faulty. Please use
M
Failure Manual/Independent mode to assist patient to breathe.
Safe Valve 1 Connection or control of PEEP relief valve gets faulty. Please use
Control Failure M Manual/Independent mode to assist patient to breathe. Parameter
monitoring is valid.
Safe Valve 2 Connection or control of PEEP relief valve gets faulty. Please use
Control Failure M Manual/Independent mode to assist patient to breathe. Parameter
monitoring is valid.
Flow sensor monitoring is invalid. Machine may work, but its accuracy
Flow Sensor Failure L
is low. Recalibrate or replace the flow sensor.
Connection of breathing system gets faulty, or ventilator cannot
Pinsp Not Achieved L provide the required pressure for the patient. Check the connection of
breathing system. Check the set values.
Leakage is detected in the breathing system. Check the connection of
Patient Circuit Leak M
breathing system and flow sensors.
Replace O2 Sensor M Oxygen sensor gets faulty. Replace the oxygen sensors.
7‐2


Previous calibration of oxygen sensor fails, or oxygen concentration
monitoring exceeds limits of validity. Check whether or not the reading
Calibrate O2 Sensor L
is 21% when the sensor stay in indoor air. Recalibrate or replace oxygen
sensors.
On Battery Power L Battery is in use.
Breathing system is not assembled, or the connecting wires of
No Breathing
H breathing system pedestal are connected incorrectly. Contact the
System
manufacturer for maintenance.
Pressure of oxygen gas supply is inadequate. If an air supply is
No O2 Pressure H connected, you may use Manual/Independent to aid the patient to
breathe. Make sure O2 gas supply of adequate pressure is connected.
5V power supply or 12Vpower supply goes wrong. Monitor is
Power Failure H unreliable. Please use Manual/Independent mode to assist patient to
breathe. Please contact the manufacturer for maintenance.
Connect or control of three‐way valve gets faulty. Machine is useable,
Zero Valve Failure L however, monitoring is unreliable. When necessary, use
manual/Independent to aid the patient to breathe.
Connection or control of expiratory valve gets faulty. Please use
Expiration Valve
M Manual/Independent mode to assist patient to breathe. Parameter
Failure
monitoring is effective.
Monitor Ventilator module fails to communicate normally with the host system.
communication H Monitor is unreliable. Please use Manual/Independent mode to assist
failure with host patient to breathe. Please contact the manufacturer for maintenance.
Oxygen sensor is not connected to the cable, or connected to the latter
Connect O2 Sensor L
poorly. Ensure that oxygen sensor and cables are normally connected.
Battery is not assembled, or the interface line of battery and power
No Battery M supply module is not connected. Please contact the manufacturer for
maintenance.
Electric quantity of battery is low. The system is operable, connect
alternating current immediately. In case of power cut, use
Low Battery
H Manual/Independent to aid the patient to breathe. If the battery
Voltage
cannot be fully charged within 24 hours, contact the manufacturer for
maintenance.
If voltage of 2 batteries is lower than 10.6V and AC is not connected,
connect ac supply immediately. In case of power cut, use
System Down For
H Manual/Independent to aid the patient to breathe. If the battery
Battery Depletion
cannot be fully charged within 24 hours, contact the manufacturer for
maintenance.
Previous calibration of flow sensor fails, or major wandering occurs in
Calibrate Flow
L the flow sensor. Please use Manual/Independent mode to assist patient
Sensor
to breathe. Calibrate the flow sensor.
Previous calibration of pressure sensor fails, or major wandering occurs
Calibrate Pressure
L in the pressure sensor. last time Please use Manual/Independent mode
Sensor
to assist patient to breathe. Calibrate the pressure sensor.
7‐3


If expiratory tidal volume >inspiratory tidal volume in previous
Check Flow Sensor L
continuous 6 cycles, check the flow sensor.
Software is reset abnormally, please restart the anesthesia machine. If
Apnea Ventilation H
the problem exists still, contact the manufacturer for maintenance.
Fresh gas is less than Please contact the manufacturer for
No Fresh Gas M
50mL/min. maintenance.
N2O sensor monitoring is Please contact the manufacturer for
N2O Sensor Failure L
invalid. maintenance.
O2 sensor monitoring is Please contact the manufacturer for
O2 Sensor Failure L
Air sensor monitoring is Please contact the manufacturer for
Air Sensor Failure L
Flowmeter Electronic flowmeter fails to
Please contact the manufacturer for
Communication H communicate with the host
maintenance.
Failure system normally.
Opening extent of O2 flow
High O2 Flow L Adjust the flow control knob, such
control knob is too big
that the flow is maintained lower than
Opening extent of air flow
High Air Flow L 10L/min.
control knob is too big
Replace the oxygen M Replace the paramagnetic oxygen sensor in the module.
sensor
Software error M Module software error. If the alarm remains after resetting the module,
please contact the manufacturer for maintenance.
Hardware error M Module hardware error. If the alarm remains after resetting the
module, please contact the manufacturer for maintenance.
Motor overspeed M Module in‐built motor overspeed. If the alarm remains after resetting
the module, please contact the manufacturer for maintenance.
Factory calibration M Module factory calibration lost. Please contact the manufacturer for
lost maintenance.
Sampling tube M Replace the sampling tube of the by‐pass flow module.
blocked
No sampling tube M Check the connection to the sampling tube.
CO2 out of M CO2 out of the measurable span of the module. If the alarm remains
tolerance range after regulating the CO2 to within the measurable span, please contact
the manufacturer for maintenance.
N2O out of M N2O out of the measurable span of the module. If the alarm remains
tolerance range after regulating the N2O to within the measurable span, please contact
O2 out of tolerance M O2 out of the measurable span of the module. If the alarm remains
range after regulating the O2 to within the measurable span, please contact
At least one M At least one anesthetic gas concentration out of the measurable span
anesthetic gas out of the module. If the alarm remains after regulating the concentration
7‐4


of the tolerance to the measurable span, please contact the manufacturer for
range maintenance.
Internal M Module internal overtemperature. Reset the module after a period of
overtemperature downtime; if the alarm remains, please contact the manufacturer for
maintenance.
Atmospheric M Please contact the manufacturer for maintenance.
overpressure
Zeroing required M Module requires manual zeroing.
AG (CO2) module L AG or CO2 module under zeroing. Do not unplug or power off the
under zeroing module.
Oxygen M Oxygen sensor in the module requires calibration; or the module has
requirement span no oxygen sensor but the oxygen option is switched on.
calibration
Anesthesia module L Anesthesia module is under standby status.
standby
Span calibration M CO2/N2O/O2 span calibration failed. Please contact the manufacturer
failed for maintenance.
Span calibration in M CO2/N2O/O2 span calibration in progress.
progress
7‐5

Chapter 8 CO Monitoring 2
8.1 Overview
CO2 monitoring function of the anesthesia machine adopts infrared absorption technology to
determine the CO2 concentration inside the patient-respiration gas circuit. Its principle is based on
such a fact that CO2 molecules have an attraction for energy contained by infrared light of specific
wavelength, and the quantity of absorbed energy is direct related to CO2 concentration. When
infrared light emitted by an infrared light supply penetrates a gas sample containing CO2, part of
the energy may be absorbed by CO2 entrained in the gas. A photoelectric detector is set up on the
opposite side of the infrared light supply to determine the residuary energy of infrared light and
convert it into electrical signals. The electrical signals are compared with the energy infrared light
supply and adjusted, and the concentration of CO2 contained in the gas sample may be precisely
reflected.
 CO2 Measuring Methods:
Sidestream
Sample the respiratory gases inside the patient-respiration gas channel at constant sampling
flow, and analyze the samples by CO2 sensor built in the module.
 CO2 Measurement may Provide:
1. CO2 waveform.
2. EtCO2: value of CO2 measured at the end of expiratory phase.
3. FiCO2: minimum CO2 value measured during inspiratory period.
Warning
 In accordance with international laws and regulations, CO2 concentration shall be monitored
during the equipment is applied on a patient. If your equipment is not provided with the
said function, please use a monitoring instrument conforming to corresponding
international standards to monitor the CO2 concentration.
Caution
 To make sure the safety of patient, CO2 monitoring shall be performed during the equipment
is running. If your equipment is not provided with the CO2 monitoring function, please use
a anesthesia machine conforming to corresponding international standards and provided
with CO2 monitoring functions to monitor the CO2 concentration.
8‐1

8.2 Identification of CO2 Monitoring

Sidestream CO2 Moduleis shown in the figure below:

1

2 5

3

4

Fig.8‐ 1Sidestream CO2 Module
1 Working indicator 4 Sampling port
2 CO2setting menu button 5 Measure/Standby button
3 Exhaust outlet
8.3 Sidestream CO2 Module

Caution
 The section is only applicable to configuration of the Sidestream CO2 module of anesthesia
machines.
8.3.1 Measuring Steps and Checks

1. Measuring Steps
To set up the <principal machine equipment> so as to conduct gas analysis, perform the
following steps:
a) Connect the Nomoline sampling tube to the input interface of ISA (CO2 module)
analyzer.
8‐2

b) Actuate <Principal Machine Equipment>.
c) In [Config] menu →Select [Gas Module] → [CO2 Module] →set the options like
[CO2 Unit] , [O2 Compensation] , [N20] and [Apnea Time] .
d) When CO2 monitoring function is turned on, its working mode is set to “measurement”
mode. However, to ensure that is set to correct functional mode, be sure to access [CO2
module], and verify whether or not its [work mode] is set to [Measure] mode.
e) Connect the sample outlet to emission system, or allow the gas to flow back to the
patient circuit.
f) Green LED indicates that ISA analyzer is operational.
g) Perform pre-service inspection as per “pre-service testing (2)”.
h) Testing result is normal, and CO2 gas monitoring is started.
采样管
Sampling Tube
采样管
Sampling Tube

Fig.8‐2 Connection Diagram
2. Pre-service Inspection
To connect the Nomoline sampling tube to respiration circuit, perform the following
operations:
a) Connect the sampling tube to the gas inlet port (LEGI) of ISA carbon dioxide module;
b) Check whether or not green lamp of LEGI goes on steadily (indicating that the system
is normal);
c) For CO2 module fitted with oxygen options: Check whether or not the oxygen readings
indicated by the principal machine equipment is correct (21%).
d) Expire air into the sampling tube, and check whether or not valid waveforms and values
of carbon dioxide are displayed on the <Principal Machine Equipment>.
e) Choke up the sampling tube with fingertip, and wait for 10 seconds.
f) Check whether or not a clogging alarm is displayed and twinkling red light goes on.
g) In appropriate cases: perform leak check of patient circuit that is connected to the
sampling tube.
8‐3

Caution
 The end of gas circuit adapter, which is connected to the gas sampling tube, shall point
upward, so as to prevent condensed water drops from entering into the gas sampling tube
and resulting in clogging.
Warning
 Please don’t stretch the cables of ISA sidestream gas instrument.
 Please don’t run the ISA Sidestream gas instrument when the ambient operating temperature
goes beyond the specified one.
 Ensure that all connections are secure and reliable. Any leakance may allow ambient air to
sneak into respiratory gases for the patients, resulting in misreading.
8.3.2 Set the CO2

In the user interface, select [Config] menu → [Gas Module] → [CO2 Module] to conduct the
following settings；or Press the CO2setting button on the module to enter [Gas Module], in which
you can set up the CO2parameters.
Fig. 8‐3 Set the Configuration of Carbon Dioxide
8.3.2.1 Set the Work Mode
Work Mode: standby, measure
Standby:
8‐4

When carbon dioxide module remains in its standby mode, the gas pump quits work so as to
extend the lifespan of module; in addition, a prompt “CO2 Module Standby” is displayed in
the message display zone.
Measure:
When the carbon dioxide module is working, green lamp of the carbon dioxide module goes
on without flickering, and measured data are sent to the monitor simultaneously.
When carbon dioxide module is connected to the instrument under normal conditions, the
module automatically switches the operating mode to “Measure” mode. However, the user
must verify that the carbon dioxide module is set to measuring mode.
When the anesthesia machine is started up for the first time, the default [Work Mode] of
CO2 monitoring function is [Measure] . If the current CO2 monitoring function is in its
standby mode, the CO2 module may be actuated only when the use may access the “User
Interface”, select [Config] menu → [Gas Module] → [CO2 Module] → [Work Mode] ,
and set it to: [Measure]；Or press the Measure/Standby button on the module to switch
between the Standby/Measure mode.When anesthesia machine is restarted, the [Work Mode]
selected before the last shutdown will be reserved.
8.3.2.2 Set the Units

In the user interface, select [Config] menu → [Gas Module] → [CO2 Module] →
[CO2Unit] , and set it to: [mmHg] , [%] or [kPa] .
8.3.2.3 Set the Gas Compensation

Warning
 Please set all sorts of compensation in accordance with actual conditions; otherwise measuring
results may deviate from actual values, resulting in misdiagnosis.
1. In [User Interface] →access [Config] menu.
2. Turn on [Gas Module] menu.
3. Set the gas compensation concentration of [CO2 module] in accordance with actual
conditions:
 [O2 Compensation]
Oxygen compensation: Three options i.e. “High”, “Medium” and “Low”. “High”
indicates oxygen compensation is 85%;”Medium” indicates oxygen compensation is
50 %; “Low” indicates oxygen compensation is 21%. The oxygen sensor can
automatically perform oxygen compensation as per sea-level elevation; therefore, the
option is maintained in defaulted mode. If no oxygen module is available for oxygen
compensation, the compensation level may be set up manually as per sea-level
elevation.
 [N2O Compensation]
8‐5

8.3.2.4 N2O compensation: User need to setting by manually when you measuring CO2 gas、ON
/OFF.Zeroing
For infrared gas analyzer, it is necessary to determine the zero reference level of carbon
dioxide measurement. The purpose is to eliminate the impact of baseline drift occurring during
measuring, and guarantee the correctness of measurements. The zeroing calibration is herein
referred to as “Zeroing”.
1. Automatic Zeroing
ISA sidestream gas instrument can automatically perform zeroing by switching the gas
sampling from respiration circuit to ambient air. The ISA carbon dioxide gas analyzer
spends less than 3 seconds to perform automatic zeroing once, and the frequency is once
every 24 hours. If ISA sidestream gas instrument is equipped with oxygen sensors, the
automatic shall include indoor air calibration of oxygen sensors as well.
2. Manual Zeroing
Sidestream CO2 module may automatic conduct zeroing when necessary. User may also
perform manual zeroing when necessary: access [Config] menu, open the [Gas Module]
menu, and select [Zero Sensor] in [CO2Module] . It is unnecessary to disconnect the
patient gas circuit prior to zeroing.
8.3.2.5 Turn on CO2 Waveform

1. In the [User Interface] , access the [Config] menu.
2. Open the [Screen] menu.
3. Set the [CO2 Wave] to [ON] as per actual requirements.
4. CO2 waveform may be viewed once you return to the [waveform] window of user
interface. As shown in the figure below.
Fig. 8‐4 CO2 waveform
8.3.3 Failure Handling

In case the sampling system of CO2 module gets abnormal, check whether or not the sampling
tubes are enlaced together. Once the input interface of sampling tube begins to flicker in red, or
Nomoline clogging message is displayed on the principal machine, replace the sampling tube.
8.3.4 Calibration
Sidestream CO2 module requires no routine checkout, however, it shall be calibrated every other
year or when the deviation of measured values gets too high.
8‐6

8.4 Symbols

Symbol Title Explanation
Instructions for service Consult instructions for use

Instructions for use Consult instructions for use

Catalog number

Serial number

Batch code

Dateof manufacture

Use by date [YYYY‐MM‐DD] The device should not be taken into operation
after the date accompanying the symbol.

Temperature limitation

Pressure limitation

Humidity limitation

Nomoline and Nomoline Airway Adapter Set are
Do not re‐use
intended for single patient use
Nomoline Family sampling lines shall be

Biohazardous waste waste
disposed as biohazardous
For EU only:
For EU only:
Electrical and electric equipment shall be
Waste Electrical and Electronic
collected and recycled in accordance with
Equipment (WEEE)
(Directive 2002/96/EC)
It shall meet medical equipment directive
CE mark 93/42/EEC when connected with medical
0197 equipments approved by MASIMO Sweden AB
IP classification indicating level “Splash‐proof”
of water protection
8‐7

Symbol Title Explanation

Rx only (US Only) Caution: Federal law restricts this
device to sale by or on the order of a licensed

healthcare practitioner.
CO2 ISA equipped to measure CO2 only

Multigas (AX+ or OR+) ISA equipped to measure multiple gases

Sigma Multigas Technology The product is fitted with MASIMO Sigma
Multigas Technology
Gas Inlet See sections 7.1 (build‐in module) or 7.2
(“plug‐in and measure” analyzer)
Gas outlet (discharge)

Defibrillation‐proof type BF The applied part of ISA is the Nomoline Family
applied part sampling line
A graph of the joint between Nomoline and

Patient circuit joint
patient circuit

A graph of the connection between Nomoline

Connect to ISA
and ISA

The product is not sterile and does not contain
Non sterile, latex free
latex
8.5 Analyzer leaning

The “plug-in and measure” ISA sidestream gas analyzers and Nomoline Adapter can be
cleaned using a cloth moistened (not wet) with max 70% ethanol or isopropyl alcohol.
To prevent cleaning liquids and dust from entering the ISAgas analyzer through its LEGI
connector, keep the Nomoline Family sampling line connected while cleaning the analyzer..
Warning
 Never sterilize or immerse the ISAsidestream gas analyzer in liquid.
8.6 Patent and brand

1. Patent statement
MASIMO Sweden AB owns the following patents which are in connection with products
introduced in this manual: SE519766, SE519779, SE523461, SE524086. Other patents are under
8‐8

application.
2. Brand
MASIMO IRMA™, MASIMO ISA™, MASIMO XTP™, Sigma Multigas Technology™, LEGI™,
Nomoline™, IRMA EZ Integrator™, MASIMO GasMaster™ and ISA MaintenanceMaster™ are
brands of Masimo Sweden AB.
8.7 Lighting signals of the anaesthetic module

A brief introduction of the LEGI indications:
Indication Status
Steady green light System OK
Blinking green light Zeroing in progress
Steady blue light Anaesthetic agent present
Steady red light Sensor error
Blinking red light Check sampling line

8.8 Adverse impact on performance

1. The following factors are known to have adverse effects on indication performance:
 Quantitative impact of humidity and condensation
 Quantitative impact of the atmospheric pressure;
 Interfering gas and water vapor;
 Other interference sources.
2. Gas detector
Volume percentage is the unit for detecting gas concentration. Definition of gas concentration is as
follows:
The collective pressure of mixed gases is detected by the cup pressure sensor in the ISA gas
analyzer.
It can be converted to other units using the actual atmospheric pressure sent fron the ISA sideway
analyzer.
Carbon dioxide (mmHg) = (carbon dioxide concentration) x (atmospheric pressure from ISA (kPa)) x
(750 / 100)
8‐9

For example: 5.0 vol% carbon dioxide @ 101.3 kPa 0.05 x 101.3 x 750 / 100 = 38 mmHg
3. Impact of humidity
The partial pressure and volume percentage of carbon dioxide, nitrogen monoxide, oxygen and
anaestdhetic gases depend on the water vapor content of the gas detected. Oxygen detection will
be calibrate. After which, the displayed value in normal environmental temperature and humidity
will be 20.8 vol% instead of the actual partial pressure. 20.8 vol% oxygen corresponds to the actual
oxygen concentration (vapor concentration is 0.7 vol%) of the air in the room. (e.g., when the
atmospheric pressure is 1013 hPa, it corresponds to 25°C and 23% RH).It always displays the real
partial pressure under existing humidity level when measuring carbon dioxide, nitrous oxide and
anaesthetic gases (such as all the gases detected by the infrared pool).
The water vapor in the respiratory gas can get saturated (BTPS) in the patient’s pulmonary alveolus
at body temperature.
When the respiratory gas is collected and put into the sampling line, its temperature becomes
close to environmental temperature before entering the ISA sidestream gas analyzer. No water can
get into ISA gas analyzer when all condensed water is removed by Nomoline. The relative humidity
of the gas collected is about 95%.
Carbon dioxide value under BTPS can be calculated with the following formula:
In which:
EtCO2 = EtCO2 value [vol %] from ISA
Pamb = atmospheric pressure [kPa] from ISA
3.8 = Typical partial pressure [kPa] of the water vapor condensed between patient’s respiration
circuit and ISA
EtCO2 (BTPS) = EtCO2 concentration [vol%] under BTPS
It is presumed that the oxygen detection has been calibrated with the in‐room air when the
humidity level is 0.7 vol% H2O.
8.9 Warnings

Warning
8‐10

 ISA sidestream gas analyzer can only be used by chemical staff who have been qualified and trained.
 Only the Nomoline produced by MASIMO can be used.
 ISA sidestream gas analyzer can not be exposed to flammable anaesthetic gases.
 Carefully disentangle the sampling lines, prevent them from intertwining around or tying the
patient’s neck.
 Never reuse the disposable sampling lines.
 Do not grab the sampling line to lift the ISA/main equipment, because the sampling line may detach
from the ISA/main equipment so the ISA/main equipment may drop on the patient.
 Used disposable sampling lines should be disposed of in compliance with the local regulations on
medical waste treatment.
 Do not use the adult/children sampling line on infants, because it can enlarge the dead space in the
infant’s circuit.
 Do not use infant sampling line on adults, because the flow resistance is too high.
 Do not use ISA sidestream gas analyzer in combination with quantitative sprays, as it can cause
clogging of the bacterial filter.
 Check the flow rate of the gas sample to see if it is too high for the patient.
 Since successful zeroing requires environmental air (21% oxygen and 0% carbon dioxide) in the air
analyzer, it must be insured that the ISA is in a well ventilated place. Avoid breathing near the ISA
sidestream gas analyzer before and after zeroing.
 The Nomoline sampling line and its interface are not sterile instruments. To avoid damage, do not
perform high pressure sterilization on any part of the sampling line.
 Never sterilize the ISA sidestream gas analyzer or immerse it in liquid.
 The detection can be interfered by mobile or radio communication equipments. Make sure to use the
ISA sidestream gas analyzer in the electromagnetic environment specified in this Manual.
 The ISA sidestream gas analyzer is only an auxiliary apparatus to facilitate patient assessment. It
must be used in combination with other life sign and symptom assessment equipments.
 When the input interface of the sampling line gives red flashing signal, or when Nomoline clogging
signal is given, replace the sampling line.
 Modification of the apparatus without the manufacturer’s permission is prohibited. If the apparatus
is modified, necessary tests and examinations must be implemented to guarantee long‐term safe
operation in the future.
 The ISA sidestream gas analyzer is not designed for MRI environment.
 The main equipment must be put outside of the MRI room during MRI scanning.
 Usage of high‐frequency surgical apparatus near the ISA/main equipment can interfere the ISA and
8‐11

make the detection results incorrect.
 Do not use the external natural heat‐dissipating function of the ISA.
 Do not exert negative pressure (like using a injector) on Nomoline to remove the condensed water.
 If the positive pressure or negative pressure in the patient’s circuit is too high, it may influence the
sample flow.
 If the discharge pressure or suction pressure is too high, the sample flow may also be influenced.
 The gas discharged should either go back to the patient’s circuit or to the exhaust system.
 If the gas sample is to be used for respiratory supply, a bacteria filter should be used always at the
discharge side.
 Put the ISA gas analyzer at a proper place, so that it will not fall on the patient’s body.
8.10 Sampling line clogged

If the anaesthetic gas passage is clogged, an “Sampling line clogged” message will be
displayed on the screen. In this case, replace the sampling line.
Warning
 Do not use ISA sidestream gas analyzer in combination with quantitative spray or spray treatment, as
it can cause clogging of the bacterial filter.
8.11 Waste gas discharge

Connect the exhaust tube to the exhaust outlet on the module, so as to discharge the wast gas
into the exhaust system.
8.12 Consumables
The Nomoline Adapter is a multiple-patient use product.
TheNomoline Adapter should be replaced according to good clinical practice or when an

occlusion message appears.Occlusion occurs when the sample flow is too low. This is
indicated by a flashing red LEGI together with a message on the medical backboard device.
8.13 Maintenance
The user shall check the gas readings regularly, and contact the manufacturer engineers for
maintenance if any anomaly is detected.
8‐12

Chapter 9 Monitoring of Anaesthetic Gas
9.1 Overview
Anaesthetic Gas (AG)can be used to measure the Anaesthetic Gas and Respiratory Gas of the
patient under anaesthetization. The Anaesthetic Gas module provides the numerical values at the
end of exhalation(Et) and the inhalation(Fi)of the following gases.
AG Survey provides:
Wave pattern of EtCO2
Survey Parameters:EtCO2, FiCO2, EtN2O, FiN2O, EtAA, FiAA, MAC
Thereinto AA stands for one of the Anaesthetic Gases of Des (Desflurane), Iso (Isoflurane), Enf
(Enflurane), Sev (Sevoflurane) and Hal (Hhalothane).
Attention
 According to the requirements of international laws and regulations, when this equipment is
applied in the anaesthetization for the patient, the density of Anaesthetic Gas needs to be
supervised and measured. If the equipment you use does not have this function, please use
the patient monitor which is in line with the corresponding international standards (ISO
11196‐1996 and ISO2164 7‐2004) to monitor the density of Anaesthetic Gas.
9.2 Measurement Principle of Anaesthetic Gas

The Respiratory Gas can be analyzed by various measurement principles. The Dispersive
Infrared (DIR)Method or the Nondispersive Infrared(NDIR)Method are commonly used to
insulate the absorption characteristics of the gas sample. The DIR Method is to use a single
optical light filter and a prism or a diffraction grating to separate the wave length of each kind of
anaesthetic. And NDIR Method is to get the infrared light go through several narrow-band light
filters and determine what kind of gas exists in the mixed gas.
The most commonly used gas analytical method is the one based on the medium of NDIR Method.
The measurement principle is based on that many gases absorb the infrared energy of a certain
wave length.
The multiple gas analyzer of by-pass flow, sampling and infrared usually sucks up the gas sample
from the junction of the patient’s breathing circuit and air passage device (such as mask, tracheal
tube or laryngeal mask tube).The rate at which the modern gas analyzer gets a sample from the
breathing circuit is between 50 ml/min and 250ml/min. The sample gas goes through a little cup
or a sample room, passing by the infrared transmitter, light filter and infrared detector. The signal
sent out by the infrared detector is in proportion with the infrared energy absorbed by the gas. In
order to quantize and identify various gases, such as laughing gas, CO2 and the five type of
9‐1

inhalational anaesthetic gases, several light filters are needed. The detected signal is amplified,
and is converted by the complex calculation of the microprocessor. Note that oxygen cannot be
detected by the infrared spectrometry.
The gas analyzer analyzes the oxygen by the affiliated technologies, such as the paramagnetic or
the oxygen sensor.
9.3 MAC(Minimum Alveolar Concentration)Calculation

MAC (MAC:minimum alveolar concentration ) is a standard for comparing the effect of the
inspiratory Anaesthetic Gases. The MAC value stands for the density of Anaesthetic Gas in the
pulmonary alveolus (one barometric pressure) which is the density that will not provoke muscular
movement response for 50% people tested on standardized pain stimulation.
If the mechanism of determining MAC value is carried out in the host equipment, the algorithm
applied in the calculation process must be recorded in detail. The following formula can be used
to calculate and show the MAC value by the density of the (exhaled) air at the end of the
exhalation.
For example, when using one or several anaesthetics, the anesthesia module measures and
get that the patient’s air at the end of the inhalation contains 4% DES, 0.5% HAL and 50%
N2O. So the MAC value is equal to
Attention
 The above formula does not take the altitude, the patient’s age and other personal factors into
consideration.
9.4 Selecting Oxygen Sensors

Paramagnetic Oxygen Analysis
Paramagnetic Oxygen Analysis is to measure the suction produced by the high magnetic fields
against the oxygen molecules in the mixed gas. The paramagnetic analyzer identify oxygen
and other gases according to the magnetization susceptibility of the magnetic field.
As oxygen is paramagnetic, the oxygen will be attracted by the magnetic field, but most of
other gases will not be attracted. In terms of proportion, if the magnetization susceptibility
of the magnetic field of oxygen is designated as 100,that of most other gases is close to zero.
The oxygen sensor suitable for ISA Gas Analyzer is the PM1116 Paramagnetic Oxygen Sensor
of Servomex. This sensor produces a symmetrical inhomogeneous magnetic field.If oxygen
9‐2

exists, the oxygen will be attracted to the most powerful part of the magnetic field. In this
magnetic field, the spinning rod is furnished with two glass balls full of nitrogen. The light
bean cast on the mirror is reflected to a pair of phototubes. The oxygen that is attracted to the
magnetic field will drive the glass balls from the most powerful part of the magnetic field and
get the rod started to rotate. When the phototubes detected the rotation, it will produce the
corresponding signal and transit the signal to a feedback system. This feedback system will run
a stream of current through the cable on the rod, which produces a restoring torque to keep the
rod in situ. This current is in proportion with the density of the oxygen, so the density of the
oxygen can be obtained by measuring the current running through the cable.
The main advantages of the Paramagnetic Oxygen Sensors include:
• short rise time
• stability and precision
• No need to change or supply chemicals
• Generally dispense with maintenance
9.5 To identify the AG Module

Sidestream AG Module is as shown below:

1

2 5

3

4
Fig. 9‐1 Sidestream AG Module
1 Working indicator 4 Sampling port
2 AG setting menu button 5 Measure/Standby button
3 Exhaust outlet
9‐3

Note
 The AG Module has been furnished with the function of automatic atmospheric pressure
compensation.
9.6 Measurement Steps and Inspection Prior to Use

1. Measurement Steps
To set the <Host Equipment> so as to start gas analysis, please take the following steps:
a) To connect the Nomoline sampling pipe to the input interface of the ISA(the anesthesia
module)Analyzer.
b) To start up the <Host Equipment>｡
c) If there is oxygen sensor, enter the user interface of the host equipment, and choose [Config]
→ [Setting] → [O2 Sensor Monitor] → [Turn on] .
d) In the [Config] Menu→ select [Gas Module] → [AG Modul] →set the items, such as [CO2

Unit] , [O2 Compensation] , [N2O] and [Apnea] .
e) When the anesthesia module is turned on, the working mode of the module is in the
“Measure” state. But in order to ensure that it is in the proper working state, please by all
means enter the [AG Module] to make sure whether the [Work Mode] is in the [Measure]
state.
f) To connect the outlet of the sample gas to the discharge system, or to make the gas to flow
back to the patient’s circuit.
g) If it is green LED indication, ISA Analyzer is available.
h) To carry out inspection before use according to the statement in the “Chapter 4 Operational
Readiness Inspection (Section 4.5)”.
i) If the inspection is normal, start to monitor the Anaesthetic Gas.
Sampling Sampling
line line

Fig. 9‐2 The sketch map of preliminary work and connection

2. Check before use
9‐4

Before connecting the Nomoline sampling pipe to the breathing circuit, carry out the following
steps:
a) Connect the sampling pipe to the interface of gas inlet (LEGI) of the ISA Anesthesia Module.
b) Check whether the green light of LEGI is steadily on or not(The indication system is normal.).
c) As for the ISA Anesthesia Module furnished with oxygen option:Check whether the oxygen
reading on the host equipment is correct or not(21%).
d) Breathe out air to the sampling pipe, and check whether the<Host Equipment> shows the
effective wave pattern and values of CO2.
e) Use the finger tip to block up the sampling pipe, and hold on for 10 minutes.
f) Examine whether there is obstruction warning and if the LEGI shows a red flashing light.
g) Under proper circumstances:Carry out enclosure check on the patient’s circuit that is linked
with the sampling pipe.
Attention
 If the interface shows the prompt of ‘no connection to the oxygen sensor, please reinstall the oxygen
sensor.
 The end of the gas curcuit adapter which connects the gas sampling pipe should piont upward so as
to prevent the condensing water drops entering the gas sampling pipe and bloking it up.
Warning
 Patients who are newborn babies are not allowed to use adult water tank, otherwise they may be
harmed.
 Do not pull the cable of ISA By‐flow Gas Analyzer.
 Do not operate the ISA By‐flow Gas Analyzer in the environment beyond the designated working
temperature.
 Make sure all connections are firm and reliable. Any leakage will result in the inclusion of ambient air
in the patient’s respiratory gas, which leads to a wrong reading.
9.7 Set up AG
Set the following items on the user interface by pressing hotkey [Config] → [Gas Module] →
[AG Module]；or Press the AG setting button on the module to enter [Gas Module], in which you
can set up the AG parameters.
9‐5

Fig. 9‐3 AG Module Configuration
9.7.1 Set up work mode

Work mode: standby, detect
Standby: When the anesthesia module is in standby mode, the air pump stops working for the
purpose to extend the life of the module. Meanwhile, it is displayed in the information area that
“The anesthesia module is standing by”.
Detection: When the anesthesia module is working, the green indicator light is steadily on, and
detection data is sent to the monitor.
When the anesthesia module is connected to the monitor on the normal anesthesia interface, the
anesthesia module can automatically change its work mode into “detection mode”, but the user
must confirm that it is under detection mode.
When the anesthesia apparatus is turned on for the first time, the default [Work Mode] is
[Measure] . If the current anesthesia module is in standby mode, user can start the anesthesia
module in the User Interface by pressing hotkey [Config] → [Gas Module] → [AG Module] →
[Work Mode] → [Measure] .Or press the Measure/Standby button on the module to switch
between the Standby/Measure mode..
9.7.2 Set the Units

In the user interface, select [Config] menu → [Gas Module] → [AG Module] → [CO2 Unit] ,
and set it to: [mmHg] , [%] or [kPa] ..
9‐6

9.7.3 O2 Compensation

Warning
 Please set the oxygen compensation based on the actual conditions, otherwise the detection result
may severely deviate from the actual value, which may lead to misdiagnosis.
There are 3 options for O2 Compensation, namely “High”, “Medium” and “Low”. “High” refers to
85% of O2 Compensation; “Medium” 50%; and “Low” 21%. As the oxygen sensor compensates
oxygen automatically based on the altitude, this option is default. When the O2 Compensation is
realized by the anaerobic module, user can manually set the compensation level according to the
altitude.
9.7.4 Zeroing
The infrared gas analyzer needs to establish a zero reference level for the CO2, N2O and
anaesthetic agent gas measurement. This zero calibration is here referred to as "zeroing".
1. Automatic zeroing
The ISA sidestream gas analyzer performs automatic zeroing by switching the gas samples from
the breathing circuit to the environmental atmosphere. The automatic zeroing is performed 1‐3
times one day and takes less than 10 seconds for ISA multiple‐gas analyzer. If the ISA sidestream
gas analyzer is equipped with an oxygen sensor, automatic zeroing shall include calibration of air
within the oxygen sensor.
2. Manual zeroing
The sidestream AGmodule can perform automatic zeroing when necessary. User can also perform
manual zeroing by entering [Config] hotkey, opening the [Gas Module] manual, and choosing
[Zeroing] in [AG Module] . It is unnecessary to disconnect the patient’s air way during zeroing.
Warning
 Since a successful zeroing requires the presence of ambient air (21% O2 and 0% CO2), ensure that the
ISA is placed in a well ventilated place. Avoid breathing near the ISAsidestream gas analyzer before or
during the zeroing procedure.
9.7.5 Turn on CO2 Waveform

1. In the [User Interface] , access the [Config] menu.
2. Open the [Screen] menu.
3. Set the [CO2 Wave] to [ON] as per actual requirements.
9‐7

4. CO2 waveform may be viewed once you return to the [waveform] window of user interface. As shown
in the figure below.

Fig. 9‐4 CO2 waveform
9.8 Anaesthetic replacement

If the anaesthetic in use is changed, the module can still detect the mixture of two gases during the
transient phase. But the time needed for anaesthetic replacement is decided by the type (low‐flow
or high‐flow) and character (pharmacokinetics) of the anaesthetic. No reminding notice will be
given by the anesthesia apparatus for anaesthetic replacement; and the MAC values displayed might
be incorrect during replacement.
ISA analyzer can recognize the anaesthetics automatically. When the content of one anaesthetic is
under the limit, while another anaesthetic accounts for a major part, the anesthesia apparatus can
detect this change, and indicate the name and data of the 2 anaesthetics (the dominant anaesthetic
and the secondary one).
9.9 Symbols
Please refer to content with corresponding of this section of "8.4Symbols" part.
9.10 Analyzer leaning

Please refer to content with corresponding of this section of " 8.5Analyzer leaning" part.

9.11 Patent and brand

Please refer to content with corresponding of this section of "8.6Patent and brand " part.

9.12 Lighting signals of the anaesthetic module

Please refer to content with corresponding of this section of "8.7Lighting signals of the anaesthetic
module " part.

9.13 Adverse impact on performance

Please refer to content with corresponding of this section of "8.8Adverse impact on performance"
9‐8

part.

9.14 Warnings
Please refer to content with corresponding of this section of "8.9Warnings " part.

9.15 Sampling line clogged

Please refer to content with corresponding of this section of "8.10 Sampling line clogged " part.

9.16 Waste gas discharge

Please refer to content with corresponding of this section of "8.11 Waste gas discharge" part.

9.17 Consumables
Please refer to content with corresponding of this section of "8.12Consumables" part.

9.18 Maintenance
Please refer to content with corresponding of this section of "8.13Maintenance" part.

9‐9

Chapter 10 Logs
10.1 Alarm Log

Alarm Log may have at most 2000 Log recording messages. Log recording messages are
stored as per precedence order of generated information, and the earliest preset event will be
overwritten if a new preset event takes place after the number of messages reaches 2000.
Alarm Log storage covers both technical alarm Logs and physiologic alarm Logs.
In the user interface, select [Log] to open a window as shown in the figure below:
Fig 10‐1Log Review
Alarm Log can record and store all physiologic alarms, technical alarms, and Log setting
information, the logging is timer-sequenced, and latest event is record foremost.
In the menu, the following operations are allowed:
1. Select [Previous] or [Next] to view the alarm Logs one by one.
2. All alarm Logs may be deleted if [Clear] is selected.
3. Select position “ ”, push the knob and select the alarm message to be viewed,
and then select [All] ( Display All), [Tech]( Technical alarm), [Phys]( Physiologic
Alarm) or [Setting] .
Caution
 When the anesthesia machine is completely powered off or turned off, the stored alarm log
may not be deleted, and the Log contents may not vary.
 If audile alarm signals no longer take place, operator may access the alarm log to view the
causes of alarm generation.
10‐1

Chapter 11 Maintenance, Cleaning and Sterilization

Warning
 Please observe applied provisions for safety protection.
 Please read carefully the Material Safety Data Sheets of each cleaning agent.
 Read carefully the instructions for operation and maintenance of all sterilization equipment.
 Wear safety gloves and spectacles. Damaged oxygen sensor may cause leak and result in
inflammation (including potassium hydroxide).
 Reusing non-sterilized breathing system and its reusable attachments may cause cross
infection; therefore, they shall be sterilized prior to each operation.
 Every time the equipment is disassembled, cleaned, sterilized or reassembled, the operations
described in the chapter “Operational Readiness Inspection” must be performed before
normal use.
 To prevent the breathing system from leaking, all components must not damaged during
disassembling and reassembling, and correct mounting shall be guaranteed, especially the
assembling of the seal rings. To conduct cleaning and sterilization, guarantee the
applicability of cleaning and sterilization methods to the components, and guarantee the
correctness of the cleaning and sterilization methods.
 Please perform removal and mounting as described in this chapter. For details of further
removal and assembling, contact After-service Department of the Company. Incorrect
removal and assembling may cause leak in the breathing system, and impact normal of the
equipment.
Caution
 Prior to initial use, the equipment shall be cleaned and sterilized as required. The cleaning
and sterilizing methods are described in this chapter.
 To avoid damages to the equipment, refer to data provided by manufacturer if you have any
questions about the cleaning agents.
 Never use organic, halogenated or petroleum-base solvents, glass cleaners, acetone or other
irritative cleaning agents.
 Please don’t use any abrasive cleaning agents (for example steel wool, silver polishing
materials or cleaning agents).
11‐1

 Liquid shall be placed away from electronic components.
 Do not allow any liquid to infiltrate into shell body of the equipment.
 For parts made of synthetic rubber, the soak time must not exceed 15 minutes so as not to lead
to expansion or accelerated aging.
 Only the parts indicated with 134ºC allow sterilization by high-temperature vapor.
 PH value of cleaning solution must range from 7.0 to 10.5.
11.1 Shell Cleaning and Sterilization of Anesthesia Machine

1. Prior to cleaning, turn off the anesthesia system and cut off the ac supply.
2. Use damping cloth soaked in soft cleaning solution (like 70% surgical spirit) to wipe the
shell surface of the anesthesia machine.
3. When shell cleaning is over, use dry lint-free cloth to remove the residual cleaning agents.
Warning
 Liquid infiltrating into the control assemblies may damage the equipment or cause personal
injury. During cleaning the shell, ensure that no liquid enters into the control assemblies,
and the equipment shall be disconnected from ac supply. Ensure that ac supply is
reconnected only when the cleaned components get dry thoroughly.
Caution
 Use only dry soft lint-free cloth to clean the display screen, and do not use liquid to clean it.
11.2 Remove and Assemble the Components Allowing Cleaning

and Sterilization of the Breathing System
To clean and sterilize the breathing system, the components of the breathing system
disassemble, which allow cleaning and sterilization, must be disassembled.

11‐2

11‐1 Assemblies of the Breathing System
Item Description Item Description

1 Support column, leather bag 9 Main body, breathing
system circuit
2 Expiratory/Inspiratory check valve 10 Sealing Washer
(unidirectional valve) Cap
3 Expiratory/Inspiratory check valve 11 Collar Clamp
(unidirectional valve)Pedestal
4 Expiratory/Inspiratory check valve 12 POP‐OFF Valve
(unidirectional valve) Flapper
5 Flow sensor 13 Folded Sack Holder
6 CollarNut of Respiratory Tube 14 Folded Sack
7 Respiratory Tube Joint 15 Bellows Cover
8 CO2absorber
Components marked with 134 °C belong to pressure-proof heat-proof type, they may be
hand-washed or machine-washed (soft cleaning agent with pH <10.5), and they shall be rinsed
thorough and air-dried. All components, exception for the oxygen sensors, gas channel
manometers and disposable flow sensors, may be washed.
If the flow sensors are made of plastics, please refer to the directive rules given in “11.3.8
Flow Sensor”.
11‐3

11.2.1 Disassemble the Absorber

1 Hold the absorber by your right hand, push anticlockwise to release the pin by your left
hand so as to release the lock catch of the absorber.
2 Take out the absorber by your right hand.
1
2
Warning
 CO2 absorbent is a type of high-causticity substance, and is strongly harmful to eyes, skin and
respiratory system of human beings. In case any organs are stained with CO2 absorbent by
accident, wash the organs with water. If irritation is not eliminated after washing, see a
doctor for help immediately.
11.2.2 Disassemble the Oxygen Sensors

1 Remove the plug fitted at one end of the oxygen sensor cable from corresponding oxygen
sensor oxygen sensor port “ ” of the principal machine, and remove the other end of the
oxygen sensor cable from the oxygen sensor port “ ”.
2 Move outward the oxygen sensor along the channel, and take it out.
1
11‐4

11.2.3 Disassemble the respiration hose and Y-piece

Caution
 To disassemble the respiration hose, hold the connectors at both ends of the respiration hose
so as not to damage the respiration hose.
 Filters must not be reused. Discarded filters shall be disposed as per local correlative laws and
Regulations, or waste disposal system established by the hospital, and they must not be
threw away any where.
1 Remove the filter from Y-piece, and remove the Y-piece.
2 Remove the expiratory hose and inspiratory hose from the expiratory port and inspirarory
port of the breathing system.
11.2.4 Disassemble the Manual Respiration Leather Bag

Just remove the manual respiration leather bag from the port of the breathing system, as
shown in the figure below:
 The anesthesia machine is provided with manual support column.
11‐5

11.2.5 Disassemble the Gas Channel Manometer

1. Push away the buckle of CPC connector inward by your left hand forcibly, and lift up the
gas channel manometer by your right hand:

1
2. When the buckle of CPC connector is released, pull out the gas channel manometer
upwards.

2

11.2.6 Disassemble the Manual Support Column

1 Loosen the screwing-down nut counterclockwise.
1

11‐6

2 Hold the manual support column by your right hand, and remove the manual support
column from breathing system by your left hand.
11.2.7 Disassemble the Bellows Assembly

1 Hold the bellows cover by both hands, and turn anticlockwise the bellows cover. Lift up
the bellows cover when the bellows cover is separated from the buckle.

1

2 Remove the folded sack from the folded sack holder.
2
11‐7

3 Press the collar clamp inward, and remove the folded sack holder.
4 Remove the collar clamp.
5 Remove the POP-OFF valve.
5
Warning
 Never disassembly the pressure relief valve. Otherwise, the pedestal, diaphragm or patient
may be damaged.
6 Remove the packing washer.
11‐8

11.2.8 Disassemble the Flow Sensor

1 Turn the respiration port nut anticlockwise, and remove the nut and respiration sleeve.
1
2 Pull the flow sensor out of the respiration port horizontally.
11.2.9 Disassemble Expiratory check valve (unidirectional valve)
Assembly
1 Hold the nut of check valve cap by hand, unscrew it counterclockwise, and take it out.
2 Take out the check valve cap.
11‐9

3 Take out the seal ring.
4 Take out the flappers.
5 Take out the flapper seat.

3
4
5
11.2.10 Disassemble Inspiratory check valve (unidirectional valve)
Assembly
For disassembling procedure of Inspiratory check valve (unidirectional valve) assembly, refer
to 11.2.9 Disassemble Expiratory check valve (unidirectional valve) Assembly.
11.2.11 Disassemble the Breathing System

11 When the assemblies described are
disassembled, hold up the breathing system
by one hand, and push and open the fixation
lock catch of the circuit switchover piece by
the other hand.
22 Remove the breathing system by both hands from the circuit switchover piece.
1 Note: Procedures for (1) and 1 shown in the right figure are identical.
2 Note: Procedures for (2) and 2 shown in the right figure are identical.
11‐10

Caution
 If it is very hard to push in or take out the breathing system, it is advisable to apply
lubricating oil onto seal ring of gas circuit port of circuit switchover piece so as to reduce the
frictional force.
11.2.12 Disassemble the AGSS Transmission and Absorption System

1 Remove the AGSS active blowoff pipe of AGSS effluent gases outlet, which is connected
to the effluent gas treatment system of the hospital.
2 The 30mm outer cone connector of hose of the transmission system.
11‐11

3 Remove the 30mm internal cone connector of hose of the transmission system.
4 Lift up the AGSS system from AGSS bracket and take it out.

4

11.2.12.1 Dismantle the Filter Gauze of AGSS Transmission and Absorption System
1. Refer to section 11.2.12 Dismantle AGSS Transmission and Absorption System for dismantling AGSS
components form anesthesia machine;
2. Hold the AGSS cover with left hand, and screw it to the right, as shown in the following figure

2

11‐12

3. Dismantle the AGSS cover, as shown in the following figure

3

4. Take out the filter gauze of AGSS transmission system, as shown in the following figure

4

4

5. Clean the filter gauze

5

11‐13

11.2.12.2 Replace the Filter Gauze of AGSS Transmission and Absorption System
Refer to section 11.2.12.1 Dismantle the Filter Gauze of AGSS Transmission and Absorption
System for the steps of replacing filter gauze.

11.3 Clean, Sterilize and Assemble the Breathing System

Components indicated with “134ºC” mark belong to high-temperature vapor-sterilization
components. For example, components made of metal or glass may be subjected to
high-pressure high-temperature sterilization, and the recommended maximum temperature is
134ºC. Utilize high-pressure vapor kettle to raise the vapor pressure, the temperature may
also be raised such that the bacterial protein may be solidified quickly. The method is
characterized by quick and reliable sterilization effect. If sterilization may be maintained for
15~20 minutes at 121ºC with vapor pressure of 1.05kg/cm 2, all bacteria and most of brood
cells may be killed.
This type of component may also be cleaned by hands. Brush thoroughly all components of
the breathing system with soft cleaning agent with pH value of 7.0 ~ 10.5, and have them
air-dried.
The flow sensors belong to plastic products, and the specific cleaning procedures are
described in 11.3.8 Flow Sensor.
Warning
 Never use talcum, zinc stearate, calcium carbonate, cornstarch or similar materials, for fear of
accretion. These materials might access lung of the patient or the gas duct, resulting in
irritation or damage.
 Never soak breathing system and oxygen sensor into the liquid together or have them
subjected to high-pressure high-temperature treatment.
 Check the parts for damages, and replace them when necessary.
All components of breathing system of the anesthesia machine may be cleaned and sterilized.
Requirements for cleaning and sterilizing different components are somewhat different.
Components of breathing system of the anesthesia machine shall be cleaned and sterilized in
time as per actual conditions in order to avoid cross infection of patients served by the
anesthesia machine.
The following cleaning and sterilizing methods are recommended for components by the
Company.
Component Medium level sterilization High level sterilization
11‐14

A* B* C*
Respiration hose and Y-piece ★ ★
Breathing mask ★ ★
Flow sensor ★
Folded sack assembly ★ ★
Inspiratory and Expiratory check valve
★ ★
(unidirectional valve) assembly
Oxygen sensor ★
Canister (carbon dioxide
★ ★
absorbent)assembly
Canister (carbon dioxide absorbent)link
★ ★
block assembly
Manual support column ★ ★
Breathing system ★ ★
Manual respiration leather bag ★ ★
AGSS assembly ★
Pressure gauge (airway) ★
★: It indicates that the type of sterilization method may be utilized.
A*: Wipe with damping cloth soaked in soft cleaning agents, and wipe-dry with dry
lint-free cloth.
B*: Rinse the components with fresh water, soak them with water and alkalescent cleaning
agent (washing liquid) (recommended water temperature is 40°C) for approximately 3
minutes, rinse them with fresh water thoroughly, and wipe them with 70 % surgical
spirit.
C*: High-pressure high-temperature steam sterilizing (maximum temperature is 134 °C).
The cleaner recommended by our company as follows:
The following cleaner is tested that was not damage the respiratory system components. And the
listed cleaner was not selling in all countries or districts. Please comply to operating guide to use
the cleaner.
Caution
 The cleaner was not displayed on the list of cleaner, PH value is between 7.0 and 10.5

11‐15

Cleaner Density
Surface cleaning Acticlor Put 7 piece of it to 1L water
Bode kohrsolin FF 61 Put 30ml of it to 1L water
Cleanisept Inapplicable
Cliniwipes Inapplicable
Hibiscrub 4 x 500 ml Inapplicable
Puraswab clean cotton Clean cotton contains 70%
alcohol
Virkon Put 1 packet to 1L water (1%)
Flow sensor cleaning Sekusept aktiv Stoste
CIDEXis must a mixture of 14 days and with a Stoste
activator bottle.
Autocleaner Dr.Weigert NeoDisher Mediclean Stoste

11.3.1 Breathing System

1. When all assemblies described previously are disassembled, adopt the recommended
methods given in 11.3 Clean, Sterilize and Assemble the Breathing System to thoroughly
clean and sterilize the breathing system.
2. Verify that the breathing system gets completely dry, assemble the breathing system as per
the procedures described in 5.1Assemble the Breathing System.
11.3.2 Manual Respiration Leather Bag

1. Clean and sterilize the respiration hose and manual respiration leather bag as per the
methods recommended in the table given in11.3 Clean, Sterilize and Assemble the Breathing
System.
2. When manual respiration leather bag is thoroughly dry, assemble the manual respiration
leather bag as per5.1.3Assemble the Manual Respiration Leather Bag.
11.3.3 Breathing Mask

Clean and sterilize the breathing mask as per the methods recommended in the table given in 11.3 Clean,
Sterilize and Assemble the Breathing System.
11.3.4 Respiration Check Valve Assembly

1. Clean and sterilize the Expiratory and Inspiratory check valve (unidirectional valve)
assembly as per the methods recommended in the table given in 11.3 Clean, Sterilize and
Assemble the Breathing System.
2. Soak check valve and its cap in sterile liquid, or place them in
high-pressurehigh-temperature vapor for cleaning and sterilization. Maximum
recommended temperature is 134ºC.
11‐16

3. When complete treatment is over and the components are dried, assemble the expiratory and
Inspiratory check valves respectively as per the procedures described in11.2.9 Disassemble
Expiratory check valve (unidirectional valve) Assemblyand11.2.10 Disassemble Inspiratory
check valve (unidirectional valve) Assembly
Warning
 Never disassemble the check valve diaphragm and check valve bonnet.
 Push the check valve downward forcibly to ensure secure assembleing. The step shall be
deteted.
11.3.5 Bellows Assembly

Caution
 Soak time of folded sack assembly in warm water and cleaning fluid must not exceed 15
minutes, so as to avoid expansion or aging.
 To air-dry the folded sack, have it hung and expanded adequately. Otherwise, accretion might
occur in the folded sack.
 The Manual bag port shall be disassembled and cleaned; otherwise, drying may take a long
time.
 To conduct high-pressure high-temperature sterilization of the bellows assembly, assemble the

Manual bag port properly. During the high-pressure high-temperature sterilization, the
Manual bag port shall be positioned upside down.
 Lean and sterilize the Manual bag port as per the methods recommended in the table given
in11.3 Clean, Sterilize and Assemble the Breathing System.
 Put the Manual bag port into the scrubbing solution prepared with warm water
(recommended temperature is 40°C) and soft washing agent (like suds), wash it gently so as
not damage the components.
 Rinse it with clean warm water.
 Put the thoroughly cleaned bellows cover into high-pressure high-temperature vapor for
sterilization, and the maximum recommended temperature is 134°C.
 Hang upside-down the sterilized Manual bag port for air-drying in a well-ventilated place
with room temperature lower than 70°C.
 When the Manual bag port is thoroughly air-dried, check the components for damages, and
then conduct assembling as per the procedures described in 5.1.4 Assemble the Bellows.
Connect the bellows assembly, respiration machine and breathing system.
 Conduct pre-service checks and testing of the system as per specific operating procedures
11‐17

described in 4.6.1 Bellows Leak Tightness Testing.
11.3.6 Canister (carbon dioxide absorbent)

Caution
 We suggest that: High-level sterilization procedure shall be performed when medium level
sterilization is over.

1. Lean and sterilize theCanister (carbon dioxide absorbent)as per the methods recommended
in the table given in 11.3 Clean, Sterilize and Assemble the Breathing System.
2. When the Canister (carbon dioxide absorbent)is thoroughly dried, pour CO2 absorbent into
the Canister (carbon dioxide absorbent).
3. Please refer to 5.2 Install the Canister (carbon dioxide absorbent),assemble the Canister
(carbon dioxide absorbent)onto the breathing system.
11.3.7 Respiration Pipeline and Y-piece

Caution
 To assemble or clean and sterilize the respiration hose, hold the connector fitted at both ends
of the respiration hose, so as not to damage the respiration hose.

1. Clean and sterilize the respiration hose and Y-piece as per the methods recommended in the
table given in 11.3 Clean, Sterilize and Assemble the Breathing System.
2. When the respiration hose and Y-piece are thoroughly dried, please refer to5.1.6Assemble
the Respiration hose and Y-piece, assemble the respiration hose and Y-piece onto the
breathing system.
11.3.8 Flow Sensor

Clean the flow sensor as per the Relevant Provision issued by the hospital or as per the methods
recommended in the table given in 11.3 Clean, Sterilize and Assemble the Breathing System.
Caution
 Never have the flow sensors subjected to high-pressure high-temperature treatment.
 Never use high pressure gas or brush to clean the flow sensors.
11‐18

 Never use unapproved cleaning agent containing polycarbonate.
 Please do not clean the internal surface of flow sensor, only use a damping cloth to wipe its
external surface.
1. Have flow sensor soaked in sanitizing solution for a period of time for sterilization.
2. When sterilization is over, rinse the flow sensor with fresh water to remove the sanitizing
solution.
3. When it is cleaned by fresh water, remove the water from the inside of the sensor before it
may be put into service.
4. Assemble flow sensors as per the procedures described in 5.1.5Assemble the Flow Sensor.
Warning
 To assemble a flow sensor, tighten the locknut of respiration port; otherwise the measuring
function of flow sensors may be disabled.
 The end where the Respiration port is connected to the respiration hose shall be kept facing
downward; Otherwise condensed moisture may flow into the breathing system and impact
the flow sensor measurement adversely.
11.3.9 Oxygen Sensor

Warning
 Never soak breathing system and oxygen sensor into the liquid together or have them
subjected to high-pressure high-temperature treatment.
 Oxygen concentration measurement may fail if there is condensed moisture on the measuring
surface of oxygen sensor. In such a case, take out the oxygen sensor, remove the condensed
water from the measuring surface, and reassemble the oxygen sensor into the breathing
system.
1. Please clean and sterilize the oxygen sensor as per the methods recommended in the table
given in 11.3 Clean, Sterilize and Assemble the Breathing System.
2. When the oxygen sensor is thoroughly dried, assemble oxygen sensors as per 5.1.7
Assemble the Oxygen Sensor
11.3.10 AGSS Transmission and Absorption System

1. Please clean and sterilize the AGSS as per the methods recommended in the table given in
11.3 Clean, Sterilize and Assemble the Breathing System.
2. Shake the removed filtering net to shake off the dust and impurity accumulated on the
11‐19

filtering net, till satisfactory cleaning effect is achieved.
3. When the sterilization of main body of the AGSS system is over, assemble the AGSS
system as per 5.8.2 Assemble the AGSS.
Warning
 AGSS shall not be subjected to high-temperature sterilization.
Caution
 When cleaning is over, do not assemble the floater onto the AGSS before it is thoroughly
dried, since any a small quantity of liquid may stick the floater onto the guide rod or sight
glass such that the floater fails to reflect actual flow rates.
 Soaking, sterilization and cleaning shall be performed strictly as per the concentration
specified in the specification sheets provided by the supplier of sanitizing solution.
11.3.11 Battery

Caution
 To extend the lifespan of batteries, use the battery at least once a month, and charge them
when electric quantity is to be exhausted.
 Please check and replace batteries regularly. The service life of batteries depends on frequency
of use and service time. Based on proper maintenance and storage, the service life of
battery is approximately 3 years. In case they are improperly used, their lifespan may be
reduced. We recommend that batteries be replaced once every 3 years.
 In case of battery fault, contact the maintainer appointed by the manufacturer for
replacement. The user must not replace it by themselves.
11‐20

Chapter 12 Maintenance and Failure Recovery
12.1 Maintenance Philosophy

Warning
 Please use approved anesthesia equipment or special-purpose lubricant for O2 equipment.
 Please don’t use lubricant containing oil or grease, which may cause a fire or explosion hazard
when O2 reaches a finite concentration.
 Used equipment might be contaminated by blood or body fluid. Please observe relevant
sterilization control and safety regulations.
 Moving parts and removable components may cause hazard of hand nipping/crushing;
therefore, move or replace system components with double care.
Do not use faulty equipment. Please allow the service representative authorized by the
Company to fulfill all required maintenance, or allow qualified professionals to fulfill the
replacement and maintenance of parts listed in the User’s Manual.
When maintenance is over, test the equipment so as to guarantee that the equipment functions
normal and meet the requirements of specifications.
Caution
 Personnel without experiences in maintenance of such equipment must not participate in the
maintenance service.
 Replace worn parts with parts produced or sold by the Company. When replacement is over,
testing shall be conducted to guarantee that the equipment conform to the specification
requirements of manufacturer.
 If service and support are required, contact the After-service Department of the Company.
 To find out further product information and relevant technical data, contact the After-service
Department of the Company, and we may provide documentary data about some
components as per physical circumstances.
12‐1

12.2 Maintenance Schedule

Caution
 In this schedule, the minimum maintenance frequency is specified as per typical case in which
2000 operating hours incur in a year. If the actual number of operating hour per year is
longer than that of the typical case, the frequency of equipment maintenance shall be
higher.
Minimum maintenance
Maintenance
frequency
Clean the external surfaces.
Daily 21% O2 calibration (oxygen sensors of the breathing system).
APL accuracy check in Manual/Independent ventilation.
Once per 2 weeks Drain the anesthesia vaporizer.
100% O2 calibration (oxygen sensors of the breathing system).

Monthly
AGSS filtering net checking
During cleaning and Check the components and seal rings for damages, and replace or maintain them
assembling when necessary.
Replace the seal rings of vaporizer soleplate and port of the breathing system. For
Yearly details, contact the After-service Department of the Company.
CO2 module calibrating.
Replace the built-inbattery. For details, please contact the After-service Department
Once per 3 years
of the Company.
Please fit a new gas cylinder washer into the standby cylinder port every time a new
standby cylinder is to be assembled.
If the colour of CO2 absorbent varies, replace CO2 absorbent of the absorber.
If the measured deviation of oxygen sensors is too high and cannot be corrected
When necessary
after being calibrated many a time, replace the oxygen sensors.
If the seal ring of flow sensor is damaged, the diaphragm is cracked or deformed, or
the sensors show deformation or cracking, replace the flow sensors.
If the hoses and silicone hose of the transmission system are torn, replace them.
12.3 Maintenance of Breathing System

If any parts are found to be cracked, broken, deformed or worn during breathing system
cleaning, replace them. For concrete operations, refer to 11.2 Remove and Assemble the
Components Allowing Cleaning and Sterilization of the Breathing System and 5.1Assemble the
12‐2

Breathing System.
12.4 O2 Calibration

Warning
 Please do not implement the calibration procedure when the system is connected to a patient.
 To calibrate an oxygen sensor, the environmental pressure must be identical with the
environmental pressure adopted for monitoring of oxygen feeding of the breathing system.
If not, the monitoring values may exceed the prescribed limits.
 To calibrate an oxygen sensor, disassemble the oxygen sensor, and reassemble the oxygen
sensor only when the oxygen sensor and its assembling position are free of accumulated
water.
 If oxygen sensor is not provided or put into service, it is unnecessary to perform O2

calibration.
12.4.1 21% O2 Calibration

Caution
 If the error of monitoring value of oxygen concentration is too high or if an oxygen sensor is
replaced with a new one, O2 calibration shall be performed.
 O2 calibration must be performed in the standby mode.
 If calibration fails, check whether or not correlative technical failure alarm is given, and
perform calibration over again when the failure is eliminated.
 If calibration fails many a time, replace the oxygen sensor, and perform calibration over
again. If calibration still fails, contact the equipment maintenance personnel or the
Company in time.
 The waste oxygen sensors shall be treated as per relevant provisions for biological hazards,
and please don’t have them burnt.
Specific Operation Steps:
1. Verify that the system is in its standby mode; otherwise push the standby key ( ) to
access the interface of [Standby] mode.
2. Select [O2 Calibration] menu → [21% O2 Calibration] , and open the [21% O2
Calibration] menu, and access the 21% O2 Calibration Interface.
12‐3

3. Remove the oxygen sensor from breathing system, and place it in air for 2~3 minutes. The
disassembling procedures are described in 10.2.2 Disassemble the Oxygen Sensors
4. In the [21% O2 Calibration] menu, select [Timer] button to time for 3 minutes. When
timing is over, push the [Start] button, the system starts “21 % O2 Calibration”, and
[Calibrating] is displayed in the interface.
5. In process of calibration, push the [Stop] button to stop the calibration in progress.
6. If the equipment passes the testing, a prompting message [Calibration Result PASS] is
displayed in the interface. Otherwise, prompting messages [Calibration Result FAIL]
and [Repeat] will be displayed, and recalibration is required in such a case.
7. Select [Exit] .
12.4.2 100% O2 Calibration

Caution
 If 100% O2 calibration fails, check whether or not correlative technical failure alarm is given,
and perform calibration over again when the failure is eliminated.
 If calibration fails many a time, replace the oxygen sensor, and perform 21% O2 calibration
over again. When “PASS” is achieved, perform 100% O2 calibration. If 100% O2
calibration still fails, contact the equipment maintenance personnel or the Company in
time.
Specific Operation Steps:
1. Ensure that “21% O2 Calibration” is finished and calibration is successful. Ensure that
[No O2 Pressure] does not occur.
2. Verify that the system is in its standby mode; otherwise push the standby key ( ) to
access the interface of [Standby] mode.
3. Select [O2 calibration] menu → [100% O2 calibration] , and open the [100 % O2
calibration] menu, and access the 100 % Oxygen calibration interface.
4. Ensure the patient is disconnected from the system.
5. Align the patient port to the atmosphere.
6. Turn on O2 gas supply input, the regulated flow shall be at least 8L/min; turn off other
gas input.
7. Wait for 2~3 minutes, or in the [21% O2 Calibration] menu, select [Timer] button to
time for 3 minutes. When timing is over, push the [Start] button, the system starts “100%
Oxygen Calibration”, and [Calibrating] is displayed in the interface.
12‐4

8. In process of calibration, if you push the [Stop] button, the calibration in progress will be
stopped.
9. If the equipment passes the testing, a prompting message [Calibration Result PASS] is
displayed in the menu. Otherwise, prompting messages [Calibration Result FALL] and
[Repeat] will be displayed, and recalibration is required in such a case.
10. Select [Exit] to complete the calibration.
12.5 Gas Channel Manometer Zeroing

If Mechanical or Manual/Independent is stopped such that the gas channel pressure is
approximate to zero, and the pointer of gas channel manometer is not returned to zero, the
pressure indication of gas channel manometer may become inaccurate. In such a case, it is
necessary to zero the gas channel manometer as per the steps given below:
1. Stop Mechanical or Manual/Independent, connect the respiration pipeline to the

breathing system, allow the patient end port of respiration pipeline to be open to the
atmosphere, and guarantee that the folded sack drops completely
2. Use a minitype flat screwdriver to open and remove the buckle of lens of the gas
channel manometer.
3. Use a screwdriver to adjust the zeroing screw, and adjust the manometer pointer to the
zero point.
4. Set the Bag/mechanical ventilation switch to its mechanical control gas-feed mode.
5. Insert the Y-piece into the leak hunting plug to seal the respiration gas circuit.
6. Push the oxygen flush valve repeatedly such that the manometer pointer beats.
7. Remove the Y-piece from leak hunting plug, release the oxygen flush button, and check
whether or not the manometer pointer returns to the zero point.
8. If the pointer fails to return to the zero point, repeat the above-mentioned procedures.
9. If pointer can return to return to the zero point normally, directly press in the lens of gas
channel manometer, and assemble the manometer properly. If the pointer still fails to
return to the zero point, please contact the After-service Department of the Company.
12.6 Maintain AGSS Transmission System
12.6.1 Maintain the Hose of AGSS Transmission System
Check the hose of transmission system, if there is any damage, please replace it.
12‐5

12.6.2 Maintain the Filter Gauze of AGSS Transmission System
There are impurities and dusts clogging the filter gauze during using AGSS transmission system. Use the
following two ways to check:
 When using the filter gauze, if the AGSS float isn’t floating, the filter gauze may be clogged.
 Place the AGSS jar at horizontal level to see whether the filter gauze is being clogged.
If the filter gauze is clogged, please refer to section 11.3.10 AGSS Transmission and Absorption System
to clean or replace it.
12.7 Remove the Water Accumulated in Breathing System

1. Connect inspiratory port and expiratory port with a piece of hose.
2. Set the system switch to “ON” ( ).
3. Access the system and select [ventilation start] .
4. Set the Bag/vent Control switch to its position “Mechanical Control” ( ).
5. Make sure that adequate gas supply is available.
6. Turn on the O2 gas supply input, and regulate the flow to at least 10L/min.
7. Keep the ventilation mode and allow the instrument to run for approximately 1~2 hours,
till the water accumulated inside the breathing system is removed.
12.8 Drain Way of Manual Drain Valve

The water accumulated in the breathing system comes from the condensation of the expiratory
watervapor and the chemical reaction of the CO2 absorbent. The lower the fresh gas flow rate is, the
more water will be accumulated:
1. The more CO2 is stored in the CO2 absorber, the more water will be produced by the chemical
reaction.
2. The more moisture and expiratory gas are stored in the breathing system and the CO2 absorber,
the more water will be produced by condensation.
If the water accumulated exits, it may affect the normal use of the breathing system. Please remove
the water accumulated with the manual drain valve before use again.

Please drain with the manual drain valve in the following steps:
1. Hold the manual drain valve and press upward to open the drain valve. The water
accumulated will be discharged, as shown in the right figure:

12‐6

1

2. After the water accumulated has been discharged, release your hand, the manual drain
valve will auto reset.
Attention
 After the water accumulated has been discharged, please reset the manual drain valve, and
make sure that the anesthesia machine can work normally.
12‐7

Chapter 13 Appendix
Warning
 Only the attachments specified in this chapter may be adopted. The adoption of other
attachments may lead to incorrect measured values or equipment failure.
 Disposable attachment can be used only once, and their reuse may cause performance
reduction or cross infection.
 If an attachment package or an attachment is torn, do not use the said attachment.
 All attachments intended to contact human body shall meet the organism compatibility
required by ISO 10993-1 Standard, they shall be compatible with non-inflammable
anesthesia gasses and anaesthetics and are expected to cause no adverse reaction when they
are exposed to human body, and they shall not work with inflammable anesthesia gasses.
 Waste attachments shall be treated as per local correlative laws and regulations or waste
disposal system established by the hospital, and they must not threw away everywhere.
Material description Type
High temperature resistant L-branch 72201
Connector High temperature resistant Y-piece 73001
Waste gas exhaust nozzle connector
Rubber bag (containing no emulsion, 1L) 70138

Manual respiration leather bag
Silicone bag (1L) 70097
Silicone bags (2L) 70098
Silicone bag (3L) 70099
Silicone corrugated pipe (for adult, 150cm ) T1719ME
Silicone corrugated pipe (for children, 100cm) T0911MA
Corrugated pipe Corrugated pipe kit for children (including corrugated

pipe, Y-piece, L-branch, filter, manual respiration leather 50458900
bag)
Corrugated pipe kit for adults (including corrugated pipe, 50456400
13‐1

Y-piece, L-branch, filter, manual respiration leather bag)
Soft-silicone face mask (for big infant, #1) 5121
Soft-silicone face mask (for children, #2) 5122
Silicone face mask (for big children, #3) 5133
Silicone face mask (for adults, #4) 5134
Silicone face mask (for big adult, ＃5) 5135
Inflatable anaesthetic mask

5312
Face mask (for big infant, #2, disposable)

5313
(for children, #3, disposable)

5314
(for big children, #4, disposable)
Inflatable anaesthetic mask (for adults, #5, disposable) 5315

5316
(for big adults, #6, disposable)
13‐2

Chapter 14 Installation and Specifications
14.1 System Pneumatic Circuits
14.1.1 Pneumatic Circuit Diagram

Fig. 14-1 Pneumatic Circuit Diagram
No. Description No. Description
1 O2 P-Line 23 Safety Valve
2 Air P-Line 24 NegativePressureValve
3 Filter 25 Expiratory Valve
4 Pressure Gauge 26 Gas Capacitor
5 Check Valve 27 Pneumatic resistor
Safety Valve (0.7MPa) MechanicalOverpressure Valve

6 28
(10cmH2O)
14‐1

7 Pressure Switch 29 Pop-Off Valve
8 Regulator(0.20MPa) 30 Bellows Assembly
9 System Switch 31 Bag/mechanical ventilation switch
10 O2 flowmeter 32 Manual bag
11 Air flowmeter 33 APL Valve
12 Single Vaporizer Holder 34 AGSS Standard Connector
13 Check Valve 35 Scavenging reservoir and noise eliminator
14 Oxygen Flush Valve 36 Sodalime canister
15 Flow restrictor 37 Inspiratory Valve
16 CGO Module 38 oxygen battery
17 Filter 39 Airway Pressure Gauge
18 Expiratory Valve 40 Inspiratory Flow Sensor
19 Oxygen Flush Valve 41 Expiratory Valve
20 Safety Valve 42 Manual Drain Valve
21 Inspiratory Valve 43 Expiratory Flow Sensor
22 Proportional PEEP Valve 44 Patient

14.1.2 Gas Supply

Gasses are delivered from gas supplies to the system through connected pipeline or gas
cylinders. Pipeline gas supplies include 3 types i.e. O2 N2O and AIR, they enter into the
system respectively through pipeline gas supply ports 1, 3 and 4, and their operating pressure
measured at the flowmeter front-end is 200kPa. Standby cylinder gas supplies include 2
types i.e. O2 and N2O, they enter into the system respectively through standby-cylinder gas
supply ports 2 and 5. Their ranges of operating pressure are respectively 6.9 ~15 Mpa and
4.2~6Mpa, and are reduced to 300 ~500kPa by pressure regulating valve 6. Each type of port
is provided with a clear flag and is capable of anti-misplug function to prevent users from
connect gas supplies incorrectly. Insides of all ports are fitted with filter and check valve, and
14‐2

manometers with color codes are used to display the pressure pipeline gas supplies and
standby cylinders. Pressure relief valve 7 is used to avoid too high input pressure of gas
supplies.
All connections are fitted with flagged gas-supply inlet port connectors, filters and check
valves. Manometer may display the pressure of gas cylinders and pipelines. Regulator may
reduce the gas cylinder pressure to a proper systemic pressure. Pressure relief valve may
assist to protect the system from being damaged by high pressure.
To Avoid Gas Supply Problems:
Connections of all air cylinders are fitted with collar clamp plugs.
i. When supply pipelines are connected, keep the gas cylinder valves in their OFF
position.
ii. When the system is not in use, cut off the gas supply lines.
Warning
 During pipeline gas feed is in use, do not set the cylinder valve to position “ON”. Gas-cylinder
gas feed may be exhausted. In such a case, gas reserves may be poorly supplied when a
pipeline fault occurs.
14.1.3 O2 Flow
O2 is directly transmitted to the O2 channel of gas mixer at line pressure or regulated gas
cylinder pressure. O2 may be also directly transmitted to the respiration machine if O2 is set
as driving gas. If the pressure is too low, alarm may be displayed in the display screen.
Secondary controller may reduce the pressure of quick charging valve and auxiliary O2
flowmeter.
When O2 button is pushed to start O2 charging, quick charging valve may provide high O2
flow (between 25 and 75l/min) to the fresh gas outlet.
14.1.4 Air and N2O

Air is directly transmitted to the air passage of gas mixer at line pressure or regulated gas
cylinder pressure. Air may also be directly transmitted to the respiration machine if air is set
as driving gas. If the air pressure is too low, alarm may be displayed in the display screen.
N20 may be directly transmitted to the N2O channel of gas mixer at pipeline pressure or
regulated gas cylinder pressure. When oxygen pressure is too low, N2O flow may be
interrupted, and the oxygen pressure may not impact the air.
14‐3

Warning
 When the pressure of O2 gas supply is lower than 100kPa, N2O gas supply is automatically cut
off by O2-N2O intercepting valve, however, the air supply will not be affected.
14.1.5 Mixed Gas

Mixed gas passes through the flowmeter outlet and anesthesia vaporizer that is set to its ON
position, flows toward the fresh gas outlet, and enters into the breathing system. Pressure
relief valve is set to the maximum outlet pressure.
14.2 Electrical Connections
14.2.1 Electrical Circuit Diagram
14.2.2 Component List
No. Component No. Component

Filter Power 250VAC 10A Panel
1 15 AG/CO2 Module
Mount
2 10A Fuse 16 Touch Screen
3 AC‐DC Power Board 17 LCD Adapter Board
14‐4

No. Component No. Component

4 Fuse 18 Display Screen
5 Auxiliary AC Output Socket 19 Backup Buzzer
6 Battery 20 Alarm lamp board
7 System Switch 21 Encoder
8 Fan 22 Button
9 DC‐DC Power board 23 O2 Sensor
10 Main Control board 24 Serial Port
11 Keyboard 25 Check Zero Valve
12 Monitor Board 26 Safe Valve
13 USB 27 Proportional Valve
14 Speaker 28 Switch Signal
14.3GB9706.1 and IEC 60601-1Applied Standard for Classification and
Components of Products
Anesthesia Machine System Classification:
Classified by category of anti‐electricshock Class I, Device With Internal Power Supply, Normal
Mobile Device
Classified by degree of anti‐electric shock BF‐Type Application Part
Classified by the safety degree under coexistence of Not suitable to apply in the place with flammable
flammable anaesthetic gas and air or oxygen or anaesthetic gas
nitrous oxide
Classified by the work shift Continuous‐operation Device
Classified by degree of water proof IPX0 Type
The anesthesia machine is integrated with pressure limitation device, expiratory gas volume
monitor, breathing system equipped with alarm system, pressure measurement device,
anesthesia breather system, anesthesia-gas purification/transmission and receiving system,
anesthesia gas delivery device, anesthesia respiration machine, O2 monitor and CO2
monitor.Where:
1 AX-400 and AX-500 anesthesia machines conform to the standard of ISO 80601-2-13;
2 Pressure limitation device, expiratory gas volume monitor and breathing system equipped
with an alarm system conform to Standard GB 9706.29;
3 Pressure measurement device and anesthesia ventilation system conform to Standard ISO
80601-2-13;
4 Anesthesia gas purification,transmission and receiving system conforms to Standard ISO

80601-2-13;
5 Anesthesia gas delivery device conforms to the Standard ISO 80601-2-13;
6 Anesthesia respiration machine conforms to Standard ISO 80601-2-13;
7 CO2 monitor conforms to Standard ISO 80601-2-55;
14‐5

8 Alarm system conforms to Standard IEC 60601-1-8;
9 Anesthesia concentration analyzer conforms to Standard ISO80601-2-55.
10 EMC conforms to Standard IEC60001-1-2.
14.4 Power Supply

AC mains
Input voltage 100 to 240 V
Input frequency 50/60 Hz
Input power 7.0A to 3.5A
Fuse T10 AL/250V
Auxiliary power source (3-Way)
Output voltage 220 to 240 V 100 to 120 V
Output frequency 50/60 Hz 50/60 Hz
Output power 1.0 A 1.8A
Fuse 3.0A/250V 4.0A/125V
Warning
 The system connected with auxiliary power must be certified by the designated IEC standards
(e.g. IEC 60950 Data Processing Equipment Standard and IEC 60601-1 Medical Equipment
Standard).
 The device provides three power sockets for auxiliary equipment of anesthetic systems (eg,
evaporator， gas analyzer), do not connect other devices with the sockets, it may effect the
patient's leakage current. Overload is not allowed.
Internal battery
Number of battery 1piece
At least 30min (when a fully-charged new battery is adopted, shutdown
Shutdown delay takes place within 30 minutes after the first low electric quantity alarm is
given)
120 min (when a fully-charged new battery is adopted, at ambient
Minimum power-on time
temperature 25ºC)
Charging time Approximately 10h (running mode or standby mode)
14‐6

14.4.1 Power Cord
Length： 5m
Voltage Rating： 100 ~ 240Vac
10A for 220~ 240Vac

Current capacity：
15A for 100 ~120Vac
Type： Three conductor power supply cord (medical grade where required)
14.5 Specifications for CO2 and AG modules
14.5.1 Specifications of ISATM(CO2, AG)sidestream gas analyzer

Detection method: infrared gas detection (infrared sensor)
1. General
Description Compact, low‐flow sidestream gas analyzers with
integrated pump, zeroing valve and flow controller.
Operating temperature ISA CO2: 0 to 50 °C (32 to 122 °F) ISA OR+/AX+: 5 to
50 °C (41 to 122 °F)
Storage temperature −40 to 70 °C (−40 to 158 °F)
Operating humidity < 4 kPa H2O (non‐condensing)
(95 %RH at 30 °C)
Storage humidity 5 to 100 %RH (condensing)2 (100 %RH at 40 °C)
Operating atmospheric pressure 525 to 1200 hPa (corresponding to a max altitude
of 5211 m / 17100 feet)
Storage atmospheric pressure 200 to 1200 hPa (corresponding to a max altitude
of 11760 m / 38 600 feet)
Ambient CO2 ≤ 800 ppm (0.08 vol%)
Mechanical robustness ISA CO2:
Meets the shock and vibration requirements for
transport of EN ISO 80601‐2‐55:2011 clause
201.15.3.5.101.2 and EN 1789:2007 clause 6.3.4.2.
ISA OR+/AX+:
Meets the shock and vibration requirements of EN
ISO
80601‐2‐55:2011 clause 201.15.3.5.101.1
Power supply 4.5 to 5.5 VDC, ISA CO2: < 1.4 W (normal op.), < 1.8
W (peak @ 5 VDC) ISA AX+: < 1.6 W (normal op.), <
2.0 W (peak @ 5 VDC) ISA OR+: < 2.0 W (normal
op.), < 2.4 W (peak @ 5 VDC)
Recovery time after defibrillator test Unaffected
14‐7

Water handling Nomoline Family sampling lines with proprietary
water removal tubing.
Sampling flow rate 50 ± 10 sml/min3

2. Data output
Breath detection Adaptive threshold, minimum 1 vol% change in CO2
concentration.
Respiration rate4 0 to 150 ± 1 breaths/min
Fi and ET4 Fi and ET are displayed after one breath and have a
continuously updated breath average.
ET will typically decrease below nominal value
(ETnom ) when respiration rate (RR) exceeds the RR
threshold (RRth) according to the following
formulas:
ISA CO2
CO2 ET=ETnom×(125RR⁄) for RRth >125
ISA OR+/AX+
CO2 ET=ETnom×√(70RR⁄) for RRth >70 N2O, O2, DES,
ENF, ISO, SEV ET=ETnom×√(50RR⁄) for RRth >50 HAL
ET=ETnom×√(35RR⁄) for RRth >35
Automatic agent identification ISA OR+/AX+: Primary and secondary agent.

3. Module
Sensor head 2 to 9 channel NDIR type gas analyzer measuring
at 4 to 10 μm. Data acquisition rate 10 kHz (sample
rate 20 Hz / channel).
O2 measurements by Servomex’s paramagnetic
sensor.
Compensations ISA CO2: Automatic compensation for pressure
and temperature. Manual compensation for
broadening effects on CO2.
ISA OR+/AX+: Automatic compensation for
pressure, temperature and broadening effects on
CO2.
Calibration No span calibration is required for the IR bench.
An automatic zeroing is performed 1 to 3 times per
day.
Warm‐up time ISA CO2: < 10 seconds (Concentrations reported
and full accuracy)
ISA OR+/AX+: < 20 seconds (Concentrations
reported, automatic agent identification enabled
and full accuracy)
14‐8

Rise time5 ISA CO2
CO2 ≤ 200 ms
ISA OR+/AX+
CO2 ≤ 300 ms
N2O, O2, ENF, ISO, SEV, DES ≤ 400 ms
HAL ≤ 500 ms
Primary agent threshold (ISA OR+/AX+) 0.15 vol%. When an agent is identified,
concentrations will be reported even below 0.15
vol%
Secondary agent threshold 0.2 vol% + 10% of total agent concentration
(ISA OR+/AX+)
Agent identification time (ISA OR+/AX+) < 20 seconds (typically < 10 seconds)
Total system response time6 ISA CO2
< 3 seconds
ISA OR+/AX+
< 4 seconds
(with 2 m Nomoline Airway Adapter Set sampling
line)

4. Gas
The precision of all detected values meet the requirements of ISO80601‐2‐55 and EN 864:1996.
Precision for standard conditions The following precisions apply to a dry gas at 22±5°C and
1013±40hPa.
1) Accuracy –standard conditions
Gas Range Accuracy

0 to 15vol% ± (0.2 vol%+2%of reading)
Carbon dioxide
15 to 25vol% Not specified
nitrogen monoxide 0 to 100 vol% ± (2 vol%+2%of reading)
0 to 8 vol% ± (0.15 vol%+5%of reading)
HAL, ENF, ISO
8 to 25 vol% Not specified
SEV
DES
Oxygen 0 to 100 vol% ± (1 vol%+2%of reading)

2) Accuracy –all conditions
Gas Accuracy
CO2 ±(0.3 kPa + 4% of reading)
N2O ±(2 kPa + 5% of reading)
14‐9

Agents8 ±(0.2 kPa + 10% of reading)

O2 ±(2 kPa + 2% of reading)

Total system response time: ISA CO2 ＜ 3s ISA OR+/AX+ ＜4s
Breath detection: adaptive threshold value, minimum CO2 concentration change is 1vol%
Breath frequency: 0‐150 times/minute
Threshold value of anaesthetic gases: main anaesthetic gas (ISA OR+/AX+):0.15 vol% When an
anaesthetic gas is marked, its concentration will be reported even if it is below 0.15 vol%.
5. Impact of interfering gases and vapor
Effects from water vapor partial pressure on gas readings When the breathing gas flows through
the sampling line, the gas temperature will adapt to the ambient temperature before reaching the
gas analyzer. The measurement of all gases will always show the actual partial pressure at the
current humidity level in the gas sample. As the NOMO section removes all condensed water, no
water will reach the ISA gas analyzer. However at an ambient temperature of 37 °C and a
breathing gas with a relative humidity of 95% the gas reading will typically be 6% lower than
corresponding partial pressure after removal of all water.
Carbon dioxide Anaesthetic nitrogen

Gases or water vapor Gas concentration
Carbon dioxide ISA AX+ gas monoxide
2)
nitrogen monoxide 4)
60 vol% _ _1) _1) _1)
HAL4) 4 vol% _1) _1) _1) _1)
Enflurane, isoflurane, +8% of the _2) _1) _1)
5 vol%
sevoflurane reading 3)
+12% of the _1) _1) _1)
Desflurane 4) 15 vol%
reading 3)
Xe(xenon) 80 vol% ‐10% of the reading 3) _1) _1)
He(helium)4) 50 vol% ‐6% of the reading 3) _1) _1)
Quantitative spray 4) Quantitative spray
1)
C2H50H(ethanol)4) 0.3 VOI% _ _1) _1) _1)
C3H70H(isopropanol)4) 0.5 VOI% _1) _1) _1) _1)
CH3COCH3(acetone)4) 1 vol% _1) _1) _1) _1)
CH4(methane)4) 3 vol% _1) _1) _1) _1)
CO(carbon monoxide)5) 1 vol% _1) _1) _1) _1)
CO(nitric oxide)5) 0.02 vol% _1) _1) _1) _1)
_2) _2) _2) _2)

Oxygen 5) 100 vol%
Note 1: The abovementioned “precision – all conditions” includes all negligible interferences
and impacts.
Note 2: The abovementioned “precision – all conditions” includes negligible interferences and
impacts when concentrations of nitrogen monoxide and oxygen are correctly set.
Note 3: Interferences at specified gas concentrations. For example, 50 vol% helium can lower
14‐10

the carbon dioxide reading by 6%. That is to say, when a gas mixture with 5.0 vol%
carbon dioxide and 50 vol% nitrogen is detected, the reading of carbon dioxide
concentration is normally (1‐0.06)* 5.0 vol%=4.7 vol% carbon dioxide.
14.5.2 Electromagnetic compatibility of the CO2 and AG modules

1 Electromagnetic compatibility
This section surpasses all requirements and MASIMO statements related to the electromagnetic
compatibility of ISA gas analyzer.
The ISA gas analyzer is designed to be used in the electromagnetic environment specified in the
table below. Clients and end users of the ISA gas analyzer must make sure that the ISA gas
analyzer is used in the proper environment.
Emission test Compliance Electromagnetic Environment ‐‐ Requirements
radio‐frequency emission Group 1 The ISA detector uses the radio frequency only for its

CISPR1 1 internal functions. Therefore, its RF value is very low
and will not cause any interference to electronic
equipments nearby.
radio‐frequency emission Type B The ISA detector is applicable to all buildings, including
CISPR1 1 civil buildings and public low‐volt power grid
harmonic emission IEC Not applicable constructions that supply power directly for civil
61000‐3‐2 buildings
Voltage fluctuation / flicker Not applicable
emission IEC 61000‐3‐3
2 Electromagnetic immunity
This section surpasses all requirements and MASIMO statements related to the electromagnetic
Immunity of ISA gas analyzer.
The ISA gas analyzer is designed to be used in the electromagnetic environment specified in the
table below. Clients and end users of the ISA gas analyzer must make sure that the ISA gas
analyzer is used in the proper environment.
Compliance Electromagnetic Environment ‐‐
Immunity test IEC 60601test level
level Requirements
Static discharge 6 kV contact 6 kV contact The floor should be paved with wood,
(ESD) 8 kV air 8 kV air concrete or ceramic. If the floor is paved with
IEC 61000‐4‐2 composite material, the relative humidity
should be 30% at least.
Electrical 2 kV corresponds to Not applicable The AC supply should be of typical
transient power cord, 1kV to commercial level
IEC 61000‐4‐4 input/output line or chemical use level.
Surge 1kV,between lines Not applicable The AC supply should be of typical
IEC 61000‐4‐5 2 kV,line to ground commercial level
or chemical use level.
Temporary volt <5% UT1(>95% Not applicable TThe AC supply should be of typical
drop, short‐term drop,UT),0.5 cycle commercial level or chemical use level. If the
disconnection and user requires that the ISA detector operate
volt change of the 40% UT normally during power‐off, uninterruptible
14‐11

Compliance Electromagnetic Environment ‐‐
Immunity test IEC 60601test level
level Requirements
input line (60% drop,UT),5 cycles power supply or battery shall be used to
IEC 61000‐4‐11 power the ISA sensor.
70% UT(30%
drop,UT),25 cycles
<5% UT(>95%
drop,UT),5 seconds
Power supply 3 A/m 3A/m The magnetic field of supply frequency
frequency should be equal to that of typical commercial
(50/60Hz) or medical environment.
magnetic field
IEC 61000‐4‐8
When using portable or movable radio
frequency communications equipment, the
distance between communications
equipment and the ISA detector should be
longer than the suggested distance calculated
with the formula applicable to emitter
frequency.
Suggested distance:

d= 0.35.
p

p 80 MHz to 800 MHz
Radio frequency 3 Vrms d=0.18
conduction 150kHz to 80MHz 10 Vrms
IEC 61000‐4‐6 d = 0.35
p 800 MHz to 2.5 GHz

In which, P refers to the maximum output
power of the emitter, its unit is watt (W); d is
the suggested distance, with the unit being
meter (m).

Radio‐frequency 3 V/m As for the field strength of the fixed radio
radiation 80MHz to 2.5GHz 20 V/m frequency emitter as measured by on the
IEC 61000‐4‐3 spot, a. It should be below the compliance
level of each frequency range. b. It may
interfere the nearby equipments with the
following sign.

1UT is the AC voltage before application of the test level.
Note 1: The higher frequency range is applicable when the range is within 80 MHz ~ 800 MHz.
Note 2: The above‐mentioned criteria may not be applicable to all conditions. Electromagnetic
propagation can be influenced by absorption and reflection of buildings, objects and
human bodies.
a. Theoretically, it can correctly predict the field strength of fixed emitters, such as radio
(cell/wireless) phone base stations, land mobile station, AM and FM radio station and TV
station. To evaluate the electromagnetic environment caused by the fixed radio frequent
14‐12

emitters, electromagnetic field measurements are necessary. If the field strength measured
in the place where ISA is used is beyond the applicable compliance level, it is necessary to
check whether ISA is functioning well. If any performance anomaly is detected, measures
must be taken, for example, changing the direction and location of ISA.
b. When the frequency is beyond the range of 150 kHz to 80 MHz, the field strength should be
under 10 V/m.
3 Distance to the radio communication equipment
In this section, it refers to the suggested distance between portable or movable radio
communication equipments and the ISA gas analyzer.
The ISA gas analyzer is designed to be used in an electromagnetic environment with controllable
radio‐frequency radiation interference. Clients and end‐users of the ISA gas analyzer shall check
the maximum output power of the communications equipments, and make sure that the distance
between portable or movable radio communication equipments and the ISA gas analyzer is not
shorter than the minimum value suggested in the table below, for the purpose to avoid
electromagnetic interference.
Distance from emitter [m]
Maximum output
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
power of emitter [W]
d=0.35
p d=0.18
p d=0.35
p
0.01 0.035 0.018 0.035

0.1 0.11 0.057 0.11
1 0.35 0.18 0.35
10 1.1 0.57 1.1
100 3.5 1.8 3.5
For emitters whose maximum output power is not included in the table above, the suggested
distance d (with meter (m) as its unit) can be calculated with the formula applicable to the
frequency of the emitters. In the formula, P refers to the maximum output power of the emitter,
its unit is watt (W); d is the suggested distance, with the unit being meter (m).
Note 1: The higher frequency range is applicable when the range is within 80 MHz ~ 800 MHz.
Note 2: The above‐mentioned criteria may not be applicable to all conditions. Electromagnetic
propagation can be influenced by absorption and reflection of buildings, objects and
human bodies.
Warning
 The detection can be influenced by movable and radio communications equipments. Make
sure the ISA gas analyzer is used in the electromagnetic environment specified in this
Manual.

14‐13

14.6 EMC and Radio Management Compliance

Anaesthesia machine Ax-400 and Ax-500 conform to EMC Standard IEC 60601-1-2 Edition 3:
2007-03.
Caution
1. Anaesthesia machines Ax-400 and Ax-500 meet the requirement of electromagnetic

compatibility in IEC60601-1-2.
2. The user needs to install and use according to electromagnetism compatibility information
which is attached with it.
3. Portable and mobile RF communication devices may influence Anaesthesia machines Ax-400
and Ax-500 performance, so Anaesthesia machines Ax-400 and Ax-500 should be kept away
from them during using.
4. Guidance and manufacturer’s declaration stated in the appendix.
Warning
5. Anaesthesia machines Ax-400 and Ax-500 should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, the Anaesthesia machines Ax-400
and Ax-500 should be observed to verify normal operation in the configuration in which it will
be used.
Table 1
Guidance and manufacturer’s declaration –electromagnetic emissions

The Anaesthesia machines Ax-400 and Ax-500 is intended for use in the electromagnetic
environment specified below. The customer or the user of the SECP-II should assure that it is used
in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions The Anaesthesia machines Ax-400 and Ax-500 uses RF
CISPR 11 energy only for its internal function. Therefore, its RF
Group 1
emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions The Anaesthesia machines Ax-400 and Ax-500) is suitable
Class B
CISPR 11 for use in all establishments other than domestic and those
Harmonic emissions directly connected to the public low-voltage power supply
Class A
IEC 61000-3-2 network that supplies buildings used for domestic purposes.
Voltage fluctuations / Complies
14‐14

flicker emissions
IEC 61000-3-3
Table 2
Guidance and manufacturer’s declaration – electromagnetic immunity

The Anaesthesia machines Ax-400 and Ax-500 is intended for use in the electromagnetic environment specified
below.
The customer or the user of the Anaesthesia machines Ax-400 and Ax-500 should assure that it is used in such
an environment.
IEC 60601 test Electromagnetic environment –
Immunity test Compliance level
level guidance
Electrostatic 　±6 kV contact ± 6 kV contact Floors should be wood, concrete or
discharge (ESD) 　±8 kV air ± 8 kV air ceramic tile. If floors are covered
with synthetic material, the relative
IEC 61000-4-2 humidity should be at least 30 %.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that of
transient/burst supply lines supply lines a typical commercial or hospital
IEC 61000-4-4 environment.
Surge ± 1 kV line(s) to ± 1 kV line(s) to Mains power quality should be that of
line(s) line(s) a typical commercial or hospital
IEC 61000-4-5 ± 2 kV line(s) to ± 2 kV line(s) to environment.
earth earth
Voltage dips, <5 % UT <5 % UT Mains power quality should be that of a
short (>95 % dip in (>95 % dip in UT) typical commercial or hospital
interruptions and UT) for 0.5 cycle environment. If the user of the
voltage variations for 0.5 cycle 40 % UT Anaesthesia machines Ax-400 and Ax-500
on power supply 40 % UT (60 % dip in UT) requires continued operation during power
input lines (60 % dip in for 5 cycles mains interruptions, it is recommended that
UT) 70 % UT the Anaesthesia machines Ax-400 and
IEC 61000-4-11 for 5 cycles (30 % dip in UT) Ax-500 be powered from an
70 % UT for 25 cycles uninterruptible power supply or a battery.
(30 % dip in <5 % UT
UT) (>95 % dip in UT)
for 25 cycles for 5 s
<5 % UT
(>95 % dip in
UT)
for 5 s
14‐15

Power frequency Power frequency magnetic fields

3 A/m 3 A/m
(50/60 Hz) should be at levels characteristic of a
magnetic field
typical location in a typical
commercial or hospital environment.
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity
The Anaesthesia machines Ax-400 and Ax-500 is intended for use in the electromagnetic environment specified below.
The customer or the user of the Anaesthesia machines Ax-400 and Ax-500 should assure that it is used in such an
environment.
Compliance Electromagnetic
Immunity test IEC 60601 test level
level environment – guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the
Anaesthesia machines Ax-400 and Ax-500,
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
Conducted RF 3Vrms 3Vrms
d = 1.2 P
IEC 61000-4-6 150kHz to 80MHz
d = 1.2 P 80MHz to 800MHz

Radiated RF 3V/m 3V/m
IEC 61000-4-3 80MHz to 2.5GHz
d = 2.3 P 800MHz to 2.5GHz
where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
a
should be less than the compliance level in each
frequency range. b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
14‐16

a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the Anaesthesia machines Ax-400 and
Ax-500 is used exceeds the applicable RF compliance level above, the Anaesthesia machines Ax-400 and
Ax-500)should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the Anaesthesia machines Ax-400 and Ax-500.
b
Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.

14.7 Physical Specifications

Dimensions of the Complete Machine
Size 773.5mm*1370mm*598mm
Weight 90kg (standard configuration) (without anesthesia evaporator and gas cylinder)
Top Plate
Maximum supporting
Maximum load‐bearing of top plate is 50kg
capacity
Operational dimensions 535mm*235mm
Workbench
Maximum supporting
Maximum supporting capacity of workbench is 20kg
capacity
Operational dimensions 465mm*275mm
Handrail
Length dimension 412mm
Drawers
Drawers 416mm*395mm*170mm
Gas-bag Sway Brace
Length: 320mm
Size
Height: 240mm
Caster Wheels
Caster wheel 5 inch
Display Screen
Type TFT LCD, allowing touch control
AX-400 8.4inch
Size
AX-500 10.4inch
Resolution 800×600 pixels
14‐17

Luminance Adjustable
LED Indication
AC indicator lamp Green LED
It goes on the anesthesia ventilator is connected to external AC power supply.
Battery indicator lamp Green LED
Battery indicator lamp constantly goes on while the machine is connected to AC
power supply.
When the system works on the basis of battery feed, battery indicator lamp
flickers as per a certain frequency (1Hz).
Mode indicator light Green LED
The indicator lamp goes on when the machine is turned on.
The indicator lamp goes out when the machine is turned off.
1 piece (yellow, red. It only flickers in red when high-level and medium-level
Alarm indicator lamp
alarms occurs simultaneously)
Audible Indication
It gives out alarm tone and key-stoke cue tones; supports multiple-level volume
Speaker
function; the alarm tones conform to IEC 60601-1-8and YY 0709.
Buzzer It may give out alarm tone in case the system cannot work normally.
Ports
1 Ac supply port
Power supply
3 auxiliary output power-supply ports
Equal-potential 1 equal-potential earthing terminal
1 RJ45 interface
Interface 1 USB interface
1 DB9 interface
14.8 Environmental Specifications

Principal Machine
Relative humidity
Item Temperature (ºC) Atmospheric pressure (kPa)
(Non-condensation)
Work 10~40 15%~95% 70~106
Transportation and –20~60 (oxygen sensor:
10%~95% 50~106
storage –20~50)
14.9 Performance Specifications
14‐18

14.9.1 Gas Circuit Specifications

Gas Supply
Pipeline gasses O2,N2O,AIR
Pipeline gas connection NIST
Standby cylinder connection PISS
Pressure range at inlet 280~600kPa

14.9.2 Gas Supply

Tube‐type Flowmeter
Air range 0~10L/Min
O2 range 0~10L/Min
N2O range 0~10L/Min
Indication range and accuracy
Accuracy The accuracy of scale marks between 10% to
100% of full scale shall be less than ±10% of hte
indicated values.
Oxygen/N2O linked system
Type Mechanical type proportional control device
Scope O2 concentration shall not be lower than 25%
14.9.3 Rapid Oxygenation

Rapid Oxygenation
When the button of “Rapid Oxygenation” is pressed, the quick inflation
Oxygenation valve provides the fresh gas outlet with high flow (25‐75 L/min) of
oxygen.
14.9.4 Breathing System Specifications

Leakage and Compliance
Leak in breathing system and
its cycle absorption assembly
(including The leakage shall not be greater than 75ml/min at 3kPa.
Manual/Independent mode and
mechanical control mode)
Compliance of breathing
Adult mode ≤4 mL/100Pa, children mode ≤3 mL/100Pa
system and its cycle
14‐19

absorption assembly
(manual/independent mode)
Leak in CO2 tourill The leakage shall not be greater than 50ml/min at 3kPa.
APL valve leak The leakage shall not be greater than 50ml/min at 3kPa (APL valve scale mark is 75)
CO2 Absorption Apparatus

Volume of CO2 absorption
Approximately 2000ml
apparatus
Ports and Connectors
Expiratory end Taper coaxial fitting of 22mm (outside) and 15 (inside)
Inspiratory end Taper coaxial fitting of 22mm (outside) and 15 (inside)
Leather bag end Taper coaxial fitting of 22mm (outside) and 15 (inside)
Pressure gauge (airway)
Scope -20~100 cmH2O
Accuracy ± (4% of full scale reading ＋ 4% of actual reading)
APL Valve
Scope 1~75 cmH2O
Touch indication Great than 30 cmH2O
Minimum opening pressure 0.3 cmH2O (dry), 0.5 cmH2O (humid)
Pressure-flow Curve of APL Valve
APL pressure APL pressure
Flow (L/min)
CmH2O, dry gas CmH2O, humid gas
3 0.17 0.18
10 0.21 0.22
20 0.26 0.27
30 0.33 0.34
40 0.42 0.43
50 0.53 0.54
60 0.71 0.73
70 0.93 0.94
Expiratory impedance of breathing system cycle absorption assembly (CO2 tourill is filled up with
“Medisord TM” CO2 absorbent)
14‐20

Inspiratory impedance of breathing system cycle absorption assembly (CO2 tourill is filled up with
“Medisord TM” CO2 absorbent)
14.10 Principle and Parameter Specifications of the Ventilator
14.10.1 Principle
Pneumatic devices of Ventilator is fitted inside the workbench of anesthesia machine.
Anesthesia machine can control the gasses flowing from solenoid valve to the patient. During
the inspiratory period, the gas flow turn off the expiratory valve and push downward the
bellows. During the expiratory period, a small gas flow applies a pressure onto the expiratory
flappers to provide end-expiratory positive pressure.
Volume and pressure measurements are provided by the flow sensors. Each flow sensor are
connected to the monitoring module through 2 pieces of pipes. The monitoring module may
measure the change in pressure of gas flow that passes through the flow sensors, while
pressure varies along with the flow.
14‐21

Ventilator obtains the values related to volumes and alarms on the basis of the data provided
by the expiratory gas flow sensors. Ventilator utilizes the other inhaling flow sensor to adjust
its output so as to adapt to the variance in fresh gas flow, minor gas leak, and the gas
compliance of the respiration circuit. Patient circuit allows compliance compensation. To
obtain further higher high accuracy, small quantity of gas conducts infiltration due to gas
resistance so as to aid to maintain the constant pressure of expiratory valve.
14.10.2 Parameter Specifications

Parameter Setting Range of Respiration Machine
Parameter Setting range Step size Working mode

Plimit (Pressure limitation) 10~100 cmH2O 1 cmH2O VCV, PCV,
Pinsp (Inspiratory pressure) 5~70 cmH2O 1 cmH2O PCV,
PEEP (Positive
OFF, 3~30 cmH2O 1 cmH2O VCV, PCV
end-expiratory pressure)
15~100 ml: 5 ml
TV (Tidal volume) 15~1500 ml 100~300 ml: 10 ml VCV
300~1500 ml: 25 ml
Freq(Breathing Frequency) 4~100 bpm 1 bpm. VCV, PCV,
I:E (Inspiratory expiratory
4:1~1:10 0.5 VCV, PCV
ratio)
OFF, 5%~60% of
TIP: TI (Inspiratory Pause) 5 VCV
inhaling time
Trig window(Trigger
5%~90% 5% VCV, PCV
window)
Performance of Ventilator
Driving pressure 280~600 kPa
Maximum inspiratory flow shall not be smaller than 100L/min when gas supply
Inspiratory flow
pressure is 280KPa.
Range of flow valve 3~100 L/min
Pressure limitation
1. Controlled by the electronic relief valve fitted inside the ventilator;2.
controlling means for
Controlled by the mechanical relief valve fitted inside the ventilator.
ventilator
Monitoring Parameters of Ventilator
MV(Per-minute
0~100 L/Min
ventilation amount)
TV(Inspiratory and
0~2500mL
expiratory tidal volume)
FiO2(Oxygen 18~100%
14‐22

concentration)
Ppeak(Gas channel
-20~120 cmH2O
pressure Paw)
Pmean(Mean pressure) -20~120 cmH2O
Pplat(Mean pressure) 0~120 cmH2O
I:E(Inspiratory- expiratory
4:1~1:12
ratio)
Freq(Respiratory rate) 0~120 bpm
Compl(Compliance) 0~250mL/cmH2O
Raw 0~500 cmH2O/(s/L)
Monitoring Parameters of Positive end-expiratoryPressure PEEP
Scope 0~70 cmH2O
14.10.3 Accuracy of Ventilator

Controls Parameters
<75 ml: ±10 ml;
TV
≥ 75mL, < 1500 mL: ±20mL or ±10% of set value, whichever is the greater.
Inspiratory pressure: ±3.0 cmH2O or ±8% or set value, whichever the greater.
Limiting pressure:±4.0cmH2O ±10% of set value, whichever is the greater.
PCV
End‐expiratory positive pressure: OFF: undefined; 3~30cmH2O: ±2.0cmH2O, or ±10% or
set value, whichever is the greater.
Freq ±1 C.P.M. or ±5% of set value, whichever is the greater.
I:E 2: 1~1: 4: ±10% of set value;Other ranges: undefined.
20%~60%: ±15% of set value;
Tip:Ti
Other ranges: undefined.
Measurement Parameters
<75 ml: ±10 ml,
TVexp
≥ 75mL, <2500 mL: ±20mL or ±10% or actual reading, whichever is the greater.
Pressure monitoring: ±3.0cmH2O or ±8% or actual reading, whichever is the greater; PEEP
Ppeak monitoring accuracy: 0~30 cmH2O: ±2.0cmH2O, or ±10% of the actual reading, whichever
is the greater; >30 cmH2O, < 70 cmH2O: ±8% of actual reading.
Freq ±1 C.P.M. or ±5% of actual reading, whichever is the greater.
I:E 2: 1~1: 4: ±10% or set value; Others: undefined.
0~30L/min: ±1L/min or ±15% of actual reading, whichever is the greater; ≥30 L/min:
MV
undefined.
14‐23

Compl 0~100mL/cmH2O: ±0.5mL/cmH2O or ±15% of actual reading, whichever is the greater;
Raw 0~200cmH2O/L/s: ±5 cmH2O/L/s or ±30% of actual reading, whichever is the greater.
Alarm Setting
Parameter Setting range Remarks
High Limit 5~1600 mL High Limit is greater than

TV
low limit
High Limit 0~ (High Limit ‐5) mL
High Limit 2~100L/min High Limit is greater than
MV
Low limit 0~ (High Limit ‐2) mL low limit
High Limit 20~105% High limit is greater than
FiO2
Low limit 18~ (High Limitt ‐2) % low limit
High Limit 2~100cmH2O High Limit is greater than
Ppeak Low limit 0~ (High Limit ‐2) cmH2O low limit
Negative pressure alarm is given when gas channel pressure is lower than ‐10cmH2O.
Alarm mute 120s
Note: * Typical conditions for precision measure:
Atmospheric pressure: 90~101 kPa;
Room temperature: 20 ~ 28 ºC;
Relative humidity: 50%~80%.
14.11 Principle and Specifications of Oxygen Sensors
14.11.1 Principle of Oxygen Sensor

Oxygen monitoring device may measure the oxygen concentration inside patient circuit.
Oxygen concentration measured by oxygen battery is displayed in the display screen of
anesthesia machine.
Oxygen battery is a type of electrochemical equipment. Oxygen penetrates into the battery
through a diaphragm and oxidize the metal electrodes. This oxidation generates a current
that is directly proportional to the oxygen partial pressure formed on the transducing surface
of electric poles. Metal electrodes are progressively eliminated in the oxidation process.
For oxygen monitoring, signal processing and analysis circuit are adopted to translate battery
signaling into corresponding percentage values of oxygen concentration. System displays the
value, and compare it to the stored alarm limits. If the value falls outside the limits,
anesthesia machine gives an appropriate alarm.
14‐24

14.11.2 Specifications of Oxygen Sensors
Oxygen sensor
Output Output 9-13 mV at 210hPa O2
Range and accuracy 18~100%, ±3%
100% O2 signal deviation 100±1%
Resolution 1hPa O2
1.5 x 106 % measurement time at 20°C
Expected operation life
0.8 x 106 % measurement time at 40°C
Response time (from 21% air to 100%
< 15s
oxygen)
Linearity Linear 0-100% O2
Operating temperature range -20°C to +50°C
Thermal compensation Fluctuation of ±2% within the range 0-40°C
Pressure range 50~200KPa
Relative humidity 0 to 99%
Output wandering at oxygen concentration
Typical value< 5% (over 1 year)
100%
Material White ABS
Packaging Sealed package
Term of validity shall not exceed 13 months after the
package is unpacked (under the terms defined by the
Period of Validity
manufacturer; otherwise the valid time may be somewhat
different)
14.12 Specifications of AGSS Transmission and Absorption System

AGSS Transmission and Absorption System
Size 535×120×155mm (h×w×d)
Applicable type of processing
High flow rate processing system 1H
system
Applicable laws and
ISO 80601-2-13 and YY 0635-2
regulations
AGSS adjustable degassing
50~80L/min
flow rate
Pumping flow impedance Lower than 2KPa at pumping flow of 75L/min
Pressure release device Pressure compensation port open to the atmosphere
14‐25

Filter Stainless steel mesh, with aperture of 140 ~ 150μm

When the processing system is not working or the degassing flow rate is
Status indication processing
lower than 50 L/min, floater drops to below the scale mark “min “marked
system
on the sight glass.
Connectors of the processing
Standard connector BS 6834-1987
system
14.13 Alarm Specifications

Alarm
Range of alarm sound pressure 45dB-85dB
Peak sound pressure of
82 dB
high-priority alarm
80 dB
medium-priority alarm
79 dB
low-priority alarm

14.14 AnaestheticVaporizer Specifications

For the using of Dräger anesthesia vaporizer, Please refer to the Dräger anesthesia vaporizer user
manual.
For the using of Penlon anesthesia vaporizer, Please refer to the Penlon anesthesia vaporizer user
manual.
14‐26

User Manual AX 400.AX 500

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User Manual AX 400.AX 500

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Chapter 1 User Responsibility ............................................................................................. 1-1

Chapter 2 Product Overview ............................................................................................... 2-1

Chapter 3 Basic Operations and Guidance ........................................................................ 3-1

3.8 Fresh Air Compensation ....................................................................................................... 3-10

Chapter 4 Operational Readiness Inspection .................................................................... 4-1

Chapter 5 Installation and Connection .............................................................................. 5-1

Chapter 6 Alarm ................................................................................................................... 6-1

6.7 Alarm Mute............................................................................................................................. 6-8

Chapter 7 Physiologic Alarms and Technical Alarms ....................................................... 7-1

Chapter 9 Monitoring of Anaesthetic Gas.......................................................................... 9-1

9.14 Warnings ................................................................................................................................. 9-9

Chapter 10 Logs ................................................................................................................ 10-1

Chapter 11 Maintenance, Cleaning and Sterilization .................................................... 11-1

Chapter 12 Maintenance and Failure Recovery ............................................................ 12-1

12.6 Maintain AGSS Transmission System .................................................................................. 12-5

Chapter 13 Appendix ........................................................................................................ 13-1

Chapter 1 User Responsibility

1.2 Intended Readers

1.3 Environmental Requirements

 The parts contacting the patient are free of natural emulsion.

1. Normal Working Condition

Operating ambient temperature: 10°C ~ 40°C;

Operating ambient relative humidity: 15% ~ 95%, non-condensation;

Atmospheric pressure: 70.0kPa~106.0kPa.

Gas supply: dry clean compressed medical-use gas of 0.28~0.6MPa.

3. Storage and Transportation Condition.

Storage ambient temperature: -20°C~60°C (oxygen battery: -20°C~50°C);

Storage ambient relative humidity: 10 % ~95%, non – non-condensation;

Atmospheric pressure: 50.0kPa~106.0kPa

1.4 Safety Information

Chapter 2 Product Overview

2.1 Introduction to the Anesthesia Machine

2.1.1 Anesthesia Machine AX-400

2.1.2 Anesthesia Machine AX-500

2.2 Symbols used in the Manual or on the Equipment

The maximum bearing weight of the bottom drawer is 3kg.

The maximum bearing weight of the loop hook is 1kg.

2.3 Abbreviation of Specific Terms

2.4 System Construction

8 Oxygen flush button

Depress at least 2 brake pedals downward by foot, the anesthesia machine

General supply socket and its system circuit

2.5 Introduction to the Machine Components

 Beware of explosion hazard. Never use inflammable anaesthetics in the system.

2.5.1 Breathing System Components

2 Canister (carbon dioxide absorbent) 10 Bellows assembly (mechanical ventilation)

3 Canister release 11 Manual bag port

4 Manual drain valve 12 Gasbag support arm

5 Leak test plug 13 Bag/mechanical ventilation switch

6 Respiratory tube hook 14 Inspiratory check valve (unidirectional valve)

Artificial gasbag suspension arm

10 Gasbag support column

Select manual/independent (gasbag) or volume control (ventilator).

2.5.2 Anesthesia Vaporizer

2.5.3 Control of Anesthesia Ventilator

2.5.3.1 Optional Functions in Ventilation Mode

2.5.3.2 Control Panel

 Touch-control display screen

15 14 13 12 11

1 Current Ventilation Mode 11 Control knob

2.5.4 Auxiliary Output Power Supply

and connection of at least 1 medical-use electrical equipment to 1 or more non-medical-use

electrical equipment. Even if there were no functional connection between single