Copyright

Edition: B00
No.: 046-001577-04
Date:04/2021
Shenzhen Comen Medical Instruments Co., Ltd.

Product Information
Product Name: Anesthesia Machine
Models: AX-600, AX-700,AX-700A , AX-800
Software Version: V5
CE information：
Address: Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building
2, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen,
Guangdong, 518106, P.R. 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 any part of the User‟s Manual
without prior written approval from Comen Company.
Edition number of the User‟s Manual is subject to upgrading without prior notice due to any changes in
software, technical specification or other causes.
The User‟s Manual is only applicable to the anesthesia machines AX-600,AX-700,AX-700A and
AX-800 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 restrictions are complied with:
 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 manufacturer is clear and legible so that Comen
I
 may identify that the products are authentically manufactured by Comen Company;
 The damages are not caused by human factors (such as dropout by accident, deliberate damage
etc.);
Comen Company will provide free service for all products satisfying the Comen's warranty conditions.
Comen may charge service fees for any service not within the product's warranty. User has to bear all
transportation cost (including custom's duties) for sending the products to Comen.

Caution

 This equipment must not be operated at home.

Warning

 It is not a medical treatment device.

Return the Product

If the product is really necessary to be returned, please follow the steps given below:
Acquire the right of return: Contact the After-sale Service Department of Comen company and inform
the personnel of the serial number of Comen instrument. The serial number can be found on the name
plate. If serial number of the equipment is not clear and legible, returning may not be accepted.
Furthermore, please indicate the serial number and date of production of the equipment, and describe
briefly the reason for returning.

After-sales Service
Provider: After-sales Service Department, Shenzhen Comen Medical Instruments Co., Ltd.
Address:Floor 10 of Building 1A , FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district,
Guangming 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-600,AX-700,AX-700A and AX-800 manufactured by the Company. The
manual offers the best starting point for a new user to begin operating the anesthesia machines.

Structure and Composition

The anesthesia machine consists of a host, an anesthesia ventilator, a flow control system, a control
monitoring display panel, an vaporizer (Dräger vapor2000, D-vapor®. Applicable anesthetics: enflurane,
isoflurane and sevoflurane for Dräger vapor2000; desflurane for D-vapor®), a ventilation system, a
anesthetic gas scavenging system.a vacuum suction, an anesthesia gas monitoring module, a
dual-frequency index module, a CO2 monitoring module, and accessories.

Scope of Application
The product is applicable to the inhaling anesthesia and respiration management in adult and pediatric
patients during the surgical operation.

Contraindication
Pneumothorax and severe pulmonary insufficiency are prohibited.

Figure
All figures in 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 operational procedures.

 [Characters]: Used to indicate the character strings of software.

Product Service Life

The expected service life of this product is 5 years.

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Blank Page

IV
 Contents

Chapter1 User Responsibility ............................................................................................. 1-1

1.1 Declaration ............................................................................................................................. 1-1

1.2 Intended Readers .................................................................................................................... 1-1
1.3 Environmental Requirements ................................................................................................. 1-1
1.4 Safety Information .................................................................................................................. 1-2
1.4.1 Symbols ................................................................................................................... 1-2
1.4.2 Warning,Caution and Attention................................................................................ 1-3

Chapter2 Product Overview ............................................................................................... 2-1

2.1 Introduction to the Anesthesia machine Series ....................................................................... 2-1

2.1.1 Anesthesia machine AX-600.................................................................................... 2-2
2.1.2 Anesthesia machine AX-700.................................................................................... 2-3
2.1.3 Anesthesia machine AX-800.................................................................................... 2-4
2.2 Symbols used in the Manual or on the Equipment ................................................................. 2-4
2.3 Abbreviation of Specific Terms ............................................................................................ 2-10
2.4 System Construction ............................................................................................................. 2-13
2.4.1 Front ....................................................................................................................... 2-13
2.4.2 Back ....................................................................................................................... 2-20
2.5 Introduction to the Machine Components ............................................................................ 2-22
2.5.1 Breathing System Components .............................................................................. 2-22
2.5.2 Structural Composition of AGSS ........................................................................... 2-24
2.5.3 Vacuum suction device .......................................................................................... 2-25
2.5.4 Auxiliary Common Gas Outlet (ACGO) ............................................................... 2-27
2.5.5 Anesthesia Vaporizer ............................................................................................. 2-28
2.5.6 Control of Anesthesia Ventilator ............................................................................ 2-29
2.5.7 Flowmeter .............................................................................................................. 2-31
2.5.8 Auxiliary Output Power Supply............................................................................. 2-32
2.5.9 Dovetail groove...................................................................................................... 2-33
2.5.10 Operation ceiling lamp ........................................................................................... 2-33
2.5.11 Flowmeter lighting ................................................................................................. 2-33
2.5.12 Workbench ergonomics.......................................................................................... 2-34
2.5.13 Breathing system hook........................................................................................... 2-34
2.5.14 Battery.................................................................................................................... 2-34
2.5.15 Serial Port .............................................................................................................. 2-34

V
 2.5.16 USB Port ................................................................................................................ 2-34
2.5.17 Network Port .......................................................................................................... 2-34
2.5.18 Equal-potential Grounding..................................................................................... 2-35

Chapter3 Basic Operations and Guidance ........................................................................ 3-1

3.1 Turn on the system.................................................................................................................. 3-1

3.1.1 Patient type .............................................................................................................. 3-3
3.1.2 Set Patient Information ............................................................................................ 3-3
3.2 Configure Volume for Alarms, Prompts and Key Operations ................................................ 3-4
3.3 Turn on/off Volume Alarm Switch.......................................................................................... 3-5
3.4 Open, close the extracorporeal circulation switch .................................................................. 3-5
3.5 Set the High/Low Alarm Limits ............................................................................................. 3-6
3.6 Vacuum suction operation ...................................................................................................... 3-6
3.6.1 Turn on the external vacuum suction device............................................................ 3-7
3.6.2 Turn off the external vacuum suction device ........................................................... 3-7
3.7 Set Parameters of Ventilator ................................................................................................... 3-8
3.7.1 Set Tidal Volume ...................................................................................................... 3-8
3.7.2 Set Respiratory Rate ................................................................................................ 3-8
3.7.3 Set the Minimum Respiratory Rate.......................................................................... 3-9
3.7.4 Set Inspiratory: Expiratory Time Ratio .................................................................... 3-9
3.7.5 Set Inspiratory Time ................................................................................................. 3-9
3.7.6 Set Inspiratory Pause................................................................................................ 3-9
3.7.7 Set Inspiratory Pressure ........................................................................................... 3-9
3.7.8 Set Support Pressure .............................................................................................. 3-10
3.7.9 Set Limiting Pressure ............................................................................................. 3-10
3.7.10 Set Positive End-Expiratory Pressure .................................................................... 3-10
3.7.11 Set Pressure Slope .................................................................................................. 3-10
3.7.12 Set Trigger Window ............................................................................................... 3-10
3.7.13 Set Inspiratory Triggering ...................................................................................... 3-11
3.7.14 Set Stop level ......................................................................................................... 3-11
3.7.15 Set Apnea Pressure................................................................................................. 3-11
3.7.16 Set Apnea Respiratory Ratio .................................................................................. 3-11
3.7.17 Set Apnea Time ...................................................................................................... 3-11
3.7.18 Set Exit Backup ..................................................................................................... 3-12
3.8 Control of Anesthesia Ventilator ........................................................................................... 3-12
3.8.1 Manual/Spont Mode............................................................................................... 3-12
3.8.2 Mechanical Ventilation Mode ................................................................................ 3-13
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 3.9 Compliance of Circuit .......................................................................................................... 3-24
3.10 Fresh Gas Compensation ...................................................................................................... 3-24
3.11 Timer .................................................................................................................................... 3-24
3.11.1 Start Timer ............................................................................................................. 3-25
3.11.2 Stop Timer .............................................................................................................. 3-25
3.11.3 Reset Timer ............................................................................................................ 3-25
3.12 Parameter Monitoring Of Ventilator ..................................................................................... 3-25
3.12.1 Parameter Display .................................................................................................. 3-26
3.12.2 Automatic waveform adjustment ........................................................................... 3-27
3.12.3 Pressure Monitoring ............................................................................................... 3-27
3.12.4 Tidal Volume Monitoring ....................................................................................... 3-27
3.12.5 Volume Monitoring ................................................................................................ 3-28
3.12.6 BIS Monitoring ...................................................................................................... 3-28
3.12.7 Oxygen Concentration Monitoring ........................................................................ 3-28
3.13 Default settings ..................................................................................................................... 3-29
3.14 Spirometry Loop ................................................................................................................... 3-29
3.14.1 Select Loop ............................................................................................................ 3-30
3.14.2 Save Reference Loop ............................................................................................. 3-31
3.15 Turn Off the System ............................................................................................................. 3-32

Chapter4 Tests before Use .................................................................................................. 4-1

4.1 Test Procedures ....................................................................................................................... 4-1

4.1.1 Test Interval ............................................................................................................. 4-1
4.1.2 Before the Anesthesia Machine Used on the First Patient Every Day ..................... 4-2
4.1.3 Before Anesthesia Machine Used on Each Patient .................................................. 4-3
4.1.4 After Anesthesia Machine is Repaired or Maintained ............................................. 4-3
4.2 Check the System ................................................................................................................... 4-3
4.2.1 Gas Supply Pipeline Test ......................................................................................... 4-4
4.2.2 Backup Gas Cylinder Test........................................................................................ 4-5
4.2.3 O2 and N2O linkage test without O2 sensor .............................................................. 4-6
4.2.4 O2 and N2O linkage test with O2 sensor ................................................................... 4-8
4.3 Anesthesia Vaporizer Back Pressure Test ............................................................................... 4-9
4.4 Alarm Tests ........................................................................................................................... 4-10
4.4.1 Monitoring the O2 Concentration and Testing Alarms ........................................... 4-10
4.4.2 Test the Minute Volume (MV) Alarm .................................................................... 4-11
4.4.3 Test the Apnea Alarm ............................................................................................. 4-11
4.4.4 Test the Sustained Airway Pressure Alarm ............................................................ 4-12
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 4.4.5 Test the High Paw Alarm ....................................................................................... 4-12
4.4.6 Test the Low Paw Alarm ........................................................................................ 4-12
4.4.7 Test the CO2 Monitor Alarm .................................................................................. 4-12
4.5 Breathing System Testing ..................................................................................................... 4-13
4.5.1 Bellows Tightness Test........................................................................................... 4-13
4.5.2 Breathing System Leak Test in Mechanical Ventilation Mode .............................. 4-14
4.5.3 Breathing System Leak Test in Manual Ventilation Mode .................................... 4-15
4.5.4 APL Valve Accuracy Testing ................................................................................. 4-16
4.5.5 Check Valve Inspection and Test ........................................................................... 4-16
4.6 Ventilator Test ....................................................................................................................... 4-17
4.7 AGSS Transfer and Receiving System Test ......................................................................... 4-17
4.7.1 Connection Leakage Test for AGSS and the Exhaust Gas Outlet of Anesthesia
Machine 4-18
4.8 Vacuum Suction System Test................................................................................................ 4-18
4.8.1 External Vacuum Suction System Test .................................................................. 4-18

Chapter5 Installation and Connection .............................................................................. 5-1

5.1 Assemble the Breathing System ............................................................................................. 5-1

5.1.1 Assemble the Breathing Circuit System .................................................................. 5-3
5.1.2 Assemble the Manual Support Column ................................................................... 5-5
5.1.3 Assemble the Manual Bag ....................................................................................... 5-6
5.1.4 Assemble the Bellows Components......................................................................... 5-6
5.1.5 Assemble the Flow Sensor ....................................................................................... 5-7
5.1.6 Assemble the Breathing Tube , Y-piece and mask ................................................... 5-8
5.1.7 Assemble the Oxygen Sensor .................................................................................. 5-9
5.1.8 Assemble the Airway Pressure Gauge ................................................................... 5-10
5.2 Install the CO2 Absorbent Canister ....................................................................................... 5-10
5.3 Replace the Canister (carbon dioxide absorbent) ................................................................. 5-14
5.4 Replace CO2 Absorbent ........................................................................................................ 5-15
5.5 Connection of Gas Supplies ................................................................................................. 5-16
5.5.1 Pipeline Inlets ........................................................................................................ 5-17
5.5.2 Waste Gas Exhaust ................................................................................................. 5-17
5.6 Assemble the Anesthesia Vaporizer ...................................................................................... 5-18
5.6.1 Assemble the Anesthesia Vaporizer ....................................................................... 5-19
5.6.2 Fill the Anesthetics................................................................................................. 5-20
5.6.3 Drain the Anesthetics ............................................................................................. 5-20
5.7 Assemble the Gas Cylinders ................................................................................................. 5-20
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 5.7.1 Gas Cylinder (1)..................................................................................................... 5-21
5.7.2 Gas Cylinder (2)..................................................................................................... 5-22
5.8 Assemble Module ................................................................................................................. 5-24
5.8.1 Assemble Sidestream AG Module ......................................................................... 5-24
5.8.2 Assemble Sidestream CO2 Module ........................................................................ 5-26
5.8.3 Install the Sidestream AG + O2 Module................................................................. 5-26
5.8.4 Assemble Mainstream CO2 Module ...................................................................... 5-26
5.8.5 Assemble Artema Sidestream AG Module ............................................................ 5-27
5.8.6 Assemble Artema Sidestream AG+O2 Module ...................................................... 5-30
5.8.7 Assemble BIS module............................................................................................ 5-30
5.8.8 Disassemble Sidestream AG Module..................................................................... 5-31
5.8.9 Disassemble Sidestream CO2 Module ................................................................... 5-32
5.8.10 Disassemble Sidestream AG + O2 Module ............................................................ 5-33
5.8.11 Disassemble Mainstream CO2 Module .................................................................. 5-33
5.8.12 Disassemble Artema Sidestream AG Module ........................................................ 5-33
5.8.13 Disassemble Artema Sidestream AG+O2 Module ................................................. 5-35
5.8.14 Disassemble BIS module ....................................................................................... 5-35
5.9 Vacuum Suction System ....................................................................................................... 5-36
5.9.1 Installation of External Vacuum Suction ............................................................... 5-36
5.10 AGSS Transfer and Receiving System ................................................................................. 5-39
5.10.1 Structure Composition of AGSS ............................................................................ 5-39
5.10.2 Assemble the AGSS ............................................................................................... 5-40
5.10.3 Effluent gas treatment system ................................................................................ 5-41

Chapter6 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 Indications ................................................................................................................... 6-2
6.2.1 Visual Alarms ........................................................................................................... 6-3
6.2.2 Audible Alarms ........................................................................................................ 6-3
6.2.3 Alarm Messages ....................................................................................................... 6-3
6.2.4 Parameter Flashing................................................................................................... 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 ........................................................................... 6-5
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 6.4.2 Set the CO2 Alarm Limits ........................................................................................ 6-7
6.4.3 Setting BIS Warning Limits ..................................................................................... 6-8
6.4.4 Setting the AG Alarm Limits ................................................................................... 6-9
6.5 Set the Alarm Levels............................................................................................................. 6-10
6.6 Alarm pause .......................................................................................................................... 6-10
6.6.1 Set the Alarm Pause ............................................................................................... 6-10
6.6.2 Canceling the Alarm pause .................................................................................... 6-11
6.7 Setting the Alarm Switch ...................................................................................................... 6-11
6.8 Measures when an Alarm Occurs ......................................................................................... 6-11
6.9 Testing Alarm System ........................................................................................................... 6-12

Chapter7 Physiological Alarms and Technical Alarms .................................................... 7-1

7.1 Physiologic Alarms ................................................................................................................. 7-1

7.2 Technical Alarms .................................................................................................................... 7-4
7.2.1 Monitor wafer Alarms .............................................................................................. 7-4
7.2.2 Flowmeter Alarms.................................................................................................... 7-8
7.2.3 Battery Alarms ......................................................................................................... 7-9
7.2.4 AG Module Alarms .................................................................................................. 7-9
7.2.5 CO2 Module Alarms ............................................................................................... 7-12
7.2.6 BIS Module Alarm Messages ................................................................................ 7-13
7.3 Prompt Information .............................................................................................................. 7-14
7.3.1 The prompt message displayed in the alarm bar .................................................... 7-14
7.3.2 The prompt message displayed in the information bar .......................................... 7-15

Chapter8 CO2 Monitoring ................................................................................................ 8-1

8.1 Overview ................................................................................................................................ 8-1

8.2 Identification of CO2 Modules................................................................................................ 8-2
8.2.1 MASIMO CO2 Module(Sidestream) ....................................................................... 8-2
8.2.2 MASIMO CO2 Module (Mainstream) ..................................................................... 8-3
8.2.3 Respironics CO2 Module (Sidestream) .................................................................... 8-3
8.2.4 Respironics CO2 Module (Mainstream) ................................................................... 8-4
8.3 Nomoline Family sampling lines ............................................................................................ 8-4
8.4 Measuring Procedure of MASIMO Sidestream, Mainstream Modules.................................. 8-6
8.4.1 Measuring Procedures and Testing of Sidestream Module ...................................... 8-6
8.4.2 Measuring Procedures and Tesitng of Mainstream Module..................................... 8-7
8.5 Measuring Procedures of Respironics Mainstream and Sidestream Modules ........................ 8-8
8.5.1 Measuring Procedures and Testing of Sidestream Module ...................................... 8-8
X
 8.5.2 Measuring Procedures and Testing of Mainstream Module..................................... 8-9
8.6 Set the CO2 ........................................................................................................................... 8-10
8.6.1 Set the Work Mode ................................................................................................ 8-11
8.6.2 Set the Units ........................................................................................................... 8-12
8.6.3 Set the Gas Compensation ..................................................................................... 8-12
8.7 Exhaust gas emission ............................................................................................................ 8-13
8.8 Maintaining and Cleaning MASIMO Mainstream/Sidestream CO2 Module ....................... 8-14
8.8.1 Zeroing ................................................................................................................... 8-14
8.8.2 Failure Handling .................................................................................................... 8-15
8.8.3 Calibration ............................................................................................................. 8-15
8.8.4 Analyzer cleaning .................................................................................................. 8-15
8.8.5 Lighting signals of the CO2 module ....................................................................... 8-15
8.8.6 Adverse impact on performance ............................................................................ 8-16
8.8.7 Warnings ................................................................................................................ 8-17
8.8.8 Sampling line clogged............................................................................................ 8-18
8.8.9 Consumables .......................................................................................................... 8-19
8.8.10 Maintenance ........................................................................................................... 8-19
8.9 Maintaining and Cleaning Respironics Mainstream/Sidestream CO2 Module ..................... 8-19
8.9.1 General Cleaning ................................................................................................... 8-19
8.9.2 Clean the Reusable Airway Adapter of Mainstream Sensor .................................. 8-19
8.9.3 Disinfection of Reusable Airway Adapter ............................................................. 8-19
8.9.4 Disinfection Frequency of Reusable Airway Adapter............................................ 8-20
8.9.5 Zeroing ................................................................................................................... 8-20

Chapter9 Monitoring AG (Anesthetic Gas) ...................................................................... 9-1

9.1 Overview ................................................................................................................................ 9-1

9.2 Measurement Principle of Anesthetic Gas .............................................................................. 9-1
9.3 MAC (Minimum Alveolar Concentration) Calculation .......................................................... 9-2
9.4 Selecting Oxygen Sensors ...................................................................................................... 9-3
9.5 Calculating the Rate and Dosage of Anesthetic ...................................................................... 9-4
9.6 Identifying the AG Module..................................................................................................... 9-5
9.6.1 MASIMO AG Module (Sidestream) ........................................................................ 9-5
9.6.2 MASIMO AG+O2 Module (Sidestream) ................................................................. 9-6
9.6.3 ARTEMA AG Module (Sidestream) ........................................................................ 9-6
9.6.4 ARTEMA AG+O2 Module (Sidestream) ................................................................. 9-7
9.7 AG module Measurement preparation.................................................................................... 9-8
9.7.1 MASIMO AG Module(Sidestream) ......................................................................... 9-8
XI
 9.7.2 MASIMO AG+O2 Module(Sidestream) .................................................................. 9-9
9.7.3 ARTEMA AG Module(Sidestream) ....................................................................... 9-11
9.7.4 ARTEMA AG+O2 Module(Sidestream) ................................................................ 9-12
9.8 Setting AG ............................................................................................................................ 9-12
9.8.1 Setting work mode ................................................................................................. 9-13
9.8.2 Set the Units ........................................................................................................... 9-14
9.8.3 Setting Gas Compensation ..................................................................................... 9-14
9.8.4 Zeroing ................................................................................................................... 9-14
9.8.5 Displaying CO2 Waveform .................................................................................... 9-15
9.9 Anesthetic replacement......................................................................................................... 9-15
9.10 Lighting signals of MASIMO AG module ........................................................................... 9-16
9.11 Adverse impact on performance ........................................................................................... 9-16
9.12 Warnings ............................................................................................................................... 9-16
9.13 Sampling line clogged .......................................................................................................... 9-16
9.14 Exhaust gas emission ............................................................................................................ 9-16
9.15 Consumables......................................................................................................................... 9-17
9.16 Maintenance.......................................................................................................................... 9-17

Chapter10 Monitoring BIS ............................................................................................. 10-1

10.1 General Introduction ............................................................................................................. 10-1

10.2 BIS module ........................................................................................................................... 10-1
10.3 BIS display ........................................................................................................................... 10-2
10.4 Safety Information ................................................................................................................ 10-4
10.5 BIS Connection..................................................................................................................... 10-4
10.6 Electrode impedance test results window ............................................................................. 10-5
10.7 Setting BIS ............................................................................................................................ 10-6
10.7.1 Set BIS smoothness................................................................................................ 10-6
10.7.2 Sensor replacement confirmation .......................................................................... 10-6
10.7.3 Set filter switch ...................................................................................................... 10-7
10.7.4 Set wave shift ......................................................................................................... 10-7
10.7.5 Set wave speed ....................................................................................................... 10-7

Chapter11 Trend and Logs ............................................................................................. 11-1

11.1 Trend Table ........................................................................................................................... 11-1

11.2 Trend Graph .......................................................................................................................... 11-2
11.3 Alarm Log ............................................................................................................................ 11-3

Chapter12 Maintenance, Cleaning and Disinfection .................................................... 12-1

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 12.1 Housing Cleaning and Disinfection of Anesthesia Machine ................................................ 12-2
12.2 Remove and Assemble the Cleanable and Disinfectionable Components of the Breathing
System 12-3
12.2.1 Disassemble the CO2 Canister................................................................................ 12-4
12.2.2 Disassemble the Oxygen Sensors .......................................................................... 12-4
12.2.3 Disassemble the Breathing Tube, Y-piece and mask.............................................. 12-5
12.2.4 Disassemble the Manual Bag ................................................................................. 12-6
12.2.5 Disassemble the Airway Gauge ............................................................................. 12-6
12.2.6 Disassemble the Manual Support Column ............................................................. 12-7
12.2.7 Disassemble the Bellows Assembly....................................................................... 12-7
12.2.8 Disassemble the Flow Sensor ................................................................................ 12-9
12.2.9 Disassemble Expiratory Check Valve Assembly ................................................. 12-10
12.2.10 Disassemble Inspiratory Check Valve Assembly ................................................. 12-10
12.2.11 Disassemble the Breathing Circuit System .......................................................... 12-11
12.2.12 Disassemble the AGSS Transfer and Receiving System ..................................... 12-11
12.2.13 Disassemble External Vacuum Suction System ................................................... 12-14
12.3 Clean, Disinfect, Sterilize and Assemble the Breathing System ........................................ 12-16
12.3.1 CO2 Canister ........................................................................................................ 12-18
12.3.2 Oxygen Sensor ..................................................................................................... 12-19
12.3.3 Breathing Tube ,Y-piece and mask ...................................................................... 12-19
12.3.4 Manual bag .......................................................................................................... 12-20
12.3.5 Airway Pressure Gauge........................................................................................ 12-20
12.3.6 Manual support column ....................................................................................... 12-20
12.3.7 Bellows Assembly................................................................................................ 12-21
12.3.8 Flow Sensor ......................................................................................................... 12-21
12.3.9 Expiratory check valve assembly ......................................................................... 12-22
12.3.10 Inspiratory check valve assembly ........................................................................ 12-23
12.3.11 Breathing Circuit system...................................................................................... 12-23
12.3.12 AGSS Transfer and Receiving System ................................................................ 12-23
12.3.13 Vacuum Suction System ...................................................................................... 12-24
12.3.14 Battery.................................................................................................................. 12-25

Chapter13 Maintenance and Failure Recovery ............................................................ 13-1

13.1 Maintenance Basics .............................................................................................................. 13-1

13.2 Maintenance Schedule .......................................................................................................... 13-2
13.3 Maintenance of Breathing System ........................................................................................ 13-3
13.4 O2 Calibration ....................................................................................................................... 13-3
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 13.4.1 21% O2 Calibration ................................................................................................ 13-4
13.4.2 100% O2 Calibration .............................................................................................. 13-4
13.5 Airway Gauge Zeroing ......................................................................................................... 13-5
13.6 Maintain AGSS Transfer System .......................................................................................... 13-6
13.6.1 Maintain the Hose of AGSS Transfer System........................................................ 13-6
13.6.2 Maintain the Filter of AGSS Transfer System ....................................................... 13-6
13.7 Maintenance of vacuum suction system ............................................................................... 13-7
13.8 Remove the Water Accumulated in Breathing System ......................................................... 13-7
13.9 Drain Way of Manual Drain Valve ....................................................................................... 13-7

Chapter14 Accessories ..................................................................................................... 14-1

Chapter15 Installation and Specifications ..................................................................... 15-1

15.1 System Gas Circuits.............................................................................................................. 15-1

15.1.1 Gas Circuit Diagram .............................................................................................. 15-1
15.1.2 Gas Supply ............................................................................................................. 15-3
15.1.3 O2 Flow .................................................................................................................. 15-4
15.1.4 Air and N2O ........................................................................................................... 15-4
15.1.5 Mixed Gas .............................................................................................................. 15-4
15.2 Electrical Connections .......................................................................................................... 15-4
15.2.1 Electrical Circuit Diagram ..................................................................................... 15-4
15.2.2 Component List...................................................................................................... 15-5
15.3 IEC 60601-1(GB9706.1) Applied Standard for Classification and Components of Products
15-6
15.4 Power Supply........................................................................................................................ 15-7
15.4.1 Power Cord ............................................................................................................ 15-9
15.5 Specifications for CO2 and AG modules .............................................................................. 15-9
15.5.1 Specifications of MASIMOTM (CO2, AG) sidestream gas analyzer ....................... 15-9
15.5.2 MASIMO（CO2）Mainstream Analyzer Specifications .................................... 15-13
15.5.3 EtCO2 specification of Respironics...................................................................... 15-13
15.5.4 Artema AG gas analysis Specification ................................................................. 15-15
15.6 BIS module specifications .................................................................................................. 15-16
15.6.1 BIS module specifications ................................................................................... 15-16
15.7 EMC and Radio Management Compliance ........................................................................ 15-16
15.8 Physical Specifications ....................................................................................................... 15-21
15.9 Environmental Specifications ............................................................................................. 15-24
15.10 Performance Specifications ................................................................................................ 15-24

XIV
 15.10.1 Gas Circuit Specifications.................................................................................... 15-24
15.10.2 Gas Supply ........................................................................................................... 15-24
15.10.3 ACGO Connector ................................................................................................ 15-25
15.10.4 Rapid Oxygenation .............................................................................................. 15-25
15.10.5 Breathing System Specifications ......................................................................... 15-25
15.11 Principle and Parameter Specifications of the Ventilator ................................................... 15-28
15.11.1 Principle ............................................................................................................... 15-28
15.11.2 Parameter Specifications ...................................................................................... 15-29
15.11.3 Accuracy of Ventilator ......................................................................................... 15-31
15.12 Principle and Specifications of Oxygen Sensors ................................................................ 15-36
15.12.1 Principle of Oxygen Sensor ................................................................................. 15-36
15.12.2 Specifications of Oxygen Sensors ....................................................................... 15-36
15.13 Specifications of AGSS Transfer and Receiving System ................................................... 15-37
15.13.1 Physical parameters ............................................................................................. 15-37
15.13.2 Performance Parameter ........................................................................................ 15-37
15.14 Vacuum suction system specifications................................................................................ 15-38
15.14.1 External vacuum suction system specifications ................................................... 15-38
15.15 Alarm Specifications .......................................................................................................... 15-39
15.15.1 The Sound Pressure Alarm................................................................................... 15-39
15.15.2 Air Source Pressure Alarm................................................................................... 15-39
15.16 Anesthetic Vaporizer Specifications ................................................................................... 15-39

Chapter16 Consideration for Environmentally Conscious Design ............................. 16-1

16.1 Instructions for Minimizing Environmental Impact during Normal Use ............................. 16-1
16.2 Information for End of Life Management ............................................................................ 16-2

XV
 Chapter1 User Responsibility

1.1 Declaration
The product shall be assembled, operated, maintained and repaired as per the User‟s Manual. The
product must be regularly checked. In case that 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 anesthetists who have participated in professional training.
Unless otherwise stated, information offered herein is only applicable to the Anesthesia machines
AX-600,AX-700,AX-700A and AX-800 manufactured 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 Anesthetics, such as ether and cyclopropane, must
not be applied to the equipment. Only the non-inflammable Anesthetics conforming to IEC
80601-2-13 requirements can be adopted. The equipment allows the adoption of

1-1
 non-flammable Anesthetics like enflurane, isoflurane, or sevoflurane, and only one type of
Anesthetics can 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. In
addition, they must be put in places out of the reach of children, and corresponding measures
shall be taken to prevent their harm to the ambient environment.

 The gas flow rate, volume and leakage specifications are expressed at STPD except for those
associated with Anesthetic breathing system are expressed at BTPS.

1. Normal Working Condition

Operating ambient temperature: 10°C ~ 40°C;
Operating ambient relative humidity: ≤93%, non-condensation;
Atmospheric pressure: 70.0kPa~106.0kPa.

2. Vacuum suction system Normal Working Condition

Operating ambient temperature: -20°C ~ 50°C;
Operating ambient relative humidity: ≤80%, non-condensation;
Atmospheric pressure: 70.0kPa~106.0kPa.

3. Storage and Transportation Condition.

Storage ambient temperature: -20°C~60°C (oxygen sensor: -20°C~50°C);
Storage ambient relative humidity: ≤93%, non -condensation;
Atmospheric pressure: 50.0kPa~106.0kPa

1.4 Safety Information

1.4.1 Symbols

This manual provides several symbols to indicate various important matters and instructions.In order to
operate the machine correctly,please note the following symbols:

Warning

 To warn you of the conditions where serious consequence, disadvantageous matters or danger

1-2
 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.

Note

 To provide extra information to explain the sentences.

1.4.2 Warning,Caution and Attention

Warning

 Do not operate the device before reading this Manual.

 The device can only be operated by trained and skilled medical personnel.

 Before operating the device, the operator must ensure that the device, connecting cables, and
accessories are intact and function properly.

 The device can only be connected to a correctly installed power socket with protective
grounding. If the power socket is not connected to a protective grounding wire, disconnect
from the power cord, or use the device’s internal battery for power supply operation.

 All analog and digital devices connected to the device must be certified by the specified IEC
standards (such as IEC 60950 Data processing equipment and IEC 60601-1(GB 9706.1)
1-3
 Medical electrical equipment standards). All configurations shall comply with the valid version
of IEC 60601-1(GB 9706.1). The personnel responsible for connecting the optional equipment
to the input / output signal port shall be responsible for configuring the medical system and
ensuring that the system complies with the provisions of IEC 60601-1(GB 9706.1).

 Multiple auxiliary output power sockets are provided on the rear of the device. These sockets
are used to provide power to additional equipment (i.e. anesthetic vaporizer, gas analyzer, etc.)
of the device. Do not connect other equipment to these sockets as it may affect patient’s leakage
current.

 The alarm shall be set according to different patient conditions. Continuous and close
monitoring of patients is the surest way to ensure patient safety.

 The physiological parameters and alarm information displayed on the screen of this device
are only for the reference of medical personnel, and cannot be directly used as a basis for
clinical treatment.

 Connect the device to AC power supply before the internal battery runs out.

 Do not open the device housing. All repairs or upgrades to the device can only be carried out
by personnel trained and authorized by the Company.

 You cannot rely on the audible alarm system only to monitor the patient.

 Adjusting the volume of the alarm to a small volume may cause the patient to be dangerous.

 In order to avoid explosion hazard, flammable anesthetics such as ethyl ether and
cyclopropane cannot be used in this device. Use only non-flammable anesthetics that meet the
requirements of ISO 80601-2-13, IEC 60601-2-13(GB 9706.29), or ISO 8835-2(YY 0635)
standard. This device can use non-flammable anesthetics such as enflurane, isoflurane, and
sevoflurane. Only one anesthetic can be used at a time.

 When disposing of abandoned anesthesia machines and packaging materials, abide by

relevant local regulations or hospital waste disposal systems. Place them out of reach of
children. Prevent damage to the surrounding environment.

 Do not turn off fresh gas until the anesthetic vaporizer is turned off. The anesthetic vaporizer
cannot be turned on without fresh gas. Otherwise, a high concentration of anesthetic vapor can
enter the equipment pipe and the surrounding air, causing harm to people and objects.

 Qualified personnel shall check the condition of the patient. In some cases, some
life-threatening situations may occur, but they do not necessarily trigger an alarm.

1-4
 Always set alarm limits to trigger an alarm before a dangerous situation occurs. Incorrect
alarm limit settings may cause the operator not to know that the patient condition has changed
dramatically.

 Connecting medical device and non-medical device to an auxiliary power socket at the same
time may increase the leakage current, thus exceeding the permissible value.

 Electric shock and fire hazard. Do not clean the device when it is turned on and / or powered
on.

 In order to prevent electric shock, this device can only be connected to the power wiring with
protective grounding.

 When using high-frequency electrosurgical equipment, the use of anti-static or conductive

breathing tubes can cause burns. Therefore, it is not recommended to use them in this device.

 There may be a risk of electric shock. This device can only be opened by authorized service
personnel.

 Disconnect the network power supply before removing the rear panel of this device or before
servicing this device.

 Failure of the central air supply system may cause multiple or even all devices connected to it
to stop working at the same time.

 Use a cleaning and disinfection program that meets your disinfection and risk management
regulations.

 Refer to applicable material safety data.

 Refer to the operation and maintenance manual for all disinfecting equipment.

 Do not inhale smoke from any disinfection process.

 Care must be taken when disposing of absorbent as it is a corrosive irritant.

 Care must be taken when lifting and operating the anesthetic vaporizer, as its weight may be
greater than expected, depending on the size and shape of the anesthetic vaporizer.

 Do not use talc, calcium stearate, corn starch or similar materials to prevent the bellows from
sticking. These materials may enter the patient’s lungs or airways, causing irritation or
damage.

 All gas sources shall be medical grade.

1-5
 Disposable items may be considered as potentially biohazardous and shall not be reused.
When disposing of these items, the relevant regulations for the hospital as well as local
pollutants and biohazards shall be observed.

 In order to avoid injury to the patient, do not test or maintain the device during use.

 Check the performance specifications of the processing system with which the receiving and
transmitting systems are to be used to ensure compatibility.

 It is not possible to use this device close to or stacked with other devices. If necessary, the
device shall be closely observed to ensure that it operates properly in the configurations used.

 Make sure that the current alarm preset for the device is appropriate for each patient.

 In any area, it is dangerous to use different alarm presets for the same or similar devices.

 Subject to the size and weight of this device, the device shall be removed by qualified
personnel.

 Excessive machine load may result in dumping. Equipment connected to the side of the
machine shall be within the rated weight range to prevent the machine from tipping over.

 When moving the device, excessive load on the device may result in danger of dumping.
Before moving the device, remove all devices on the top panel of the device and all monitoring
devices installed on the side of the device. Be careful when moving the device up and down
ramps, turning corners, and crossing the threshold. Do not attempt to run over hoses, cables,
or other obstacles when moving the device.

 Leakage may affect accuracy. Test before proper operation to ensure proper operation of the
device. Do not use leaked circuits.

 It is recommended to connect the vent of the device to the hospital’s exhaust emission system
to prevent hospital personnel from being exposed to the gases emitted by the device.

 Operating the device below the minimum flow rate may result in inaccurate results.

 Improperly cleaned materials can cause biological contamination. Use a cleaning and
disinfection program that meets your disinfection and risk management regulations

 Refer to applicable material safety data.

 Refer to the operation and maintenance manual for all disinfecting equipment.

 Users shall follow recommended daily disinfection procedures for this device and any

1-6
 reusable accessories.

 If this device is damaged in any way that endangers the safety of the patient or user, stop
using the device and attach a visible mark to indicate that the device is not available. Contact
the Company for technical support.

 High concentrations of O2 greatly increase the likelihood of fire or explosion. Oil and grease
may burn at the same time. Therefore, oil or grease cannot be used in oxygen-rich
environments where possible.

 Use this device only by professional medical personnel. This device may cause radio
interference or interrupt the operation of nearby devices. It is necessary to take circumvention
measures, such as repositioning the orientation or position of the device, or shielding the place
where the device is placed.

 Make sure that there is an independent ventilation mode available at any time during the use
of this device.

 The use of damaged accessories in packaging may result in biological contamination or

malfunction. The operator shall check the accessory packaging before use to ensure the
integrity of the storage.

 Before using this anesthesia machine after cleaning or disinfection, power on the system and
follow the on-screen instructions to perform a leak test.

 Use of lubricants not recommended by the Company will increase the risk of fire or explosion.
Use the lubricants approved by the Company.

 Low pressure regulators and flowmeters are susceptible to high pressure and may explode
under pressure if improperly maintained or disassembled. Only qualified personnel should
replace or disassemble the connector.

 Do not disassemble low pressure regulators, flowmeter devices, or connectors under pressure.
Sudden release of pressure may cause injury.

 Check the specifications of the AGSS transmitting and receiving systems and the
specifications of this device to ensure compatibility and prevent the receiving system from
being mismatched.

 Repeated use of non-sterile breathing circuits or reusable accessories can cause

cross-infection. Sterilize the breathing circuits and reusable accessories before use.

 Before each use, carefully inspect all parts of the breathing system. Make sure that all parts

1-7
 are free of any obstacles or debris that pose a potential hazard to the patient.

 The power plug is used to separate the anesthesia system circuit from the power supply. Do
not place the device where it is difficult to operate the plug.

 When connecting an external device through the input / output signal port or replacing the O2
battery, do not touch the patient to prevent the patient from leaking current exceeding the
standard requirements.

 Avoid connecting two or more hose assemblies in series, which can cause pressure and flow
losses.

 When the pipe between the exhaust gas treatment system and the AGSS is clogged, the
extraction flow of the exhaust gas treatment system is insufficient, or the exhaust gas treatment
system cannot work, the exhaust gas in the AGSS may overflow the atmosphere at a speed
exceeding 100ml/min. At this time, AGSS is not recommended.

 Use of incorrect connectors can be dangerous. Ensure that all components use the correct
connectors.

 Avoid using lower nominal pressure flexible connectors to replace high-pressure flexible
connectors.

 After changing the CO2 absorbent or installing a CO2 absorption canister, make sure that
CO2 is fully absorbed by the absorbent.

 Before moving the device, remove the spare cylinder and the objects on the top plate and
bracket to prevent the device from tipping.

Caution

 In order to ensure patient safety, use the parts and accessories specified in this Manual.

 This device can operate normally at the level of interference immunity identified in this
Manual. If the interference level is higher than this level, it may trigger an alarm and may
cause mechanical ventilation to stop. Pay attention to false alarms caused by high-intensity
electric fields.

 The device may lose its balance if it is tilted more than 10°. Be careful when moving or
placing this device on a slope that exceeds 10°. Do not hang objects on both sides of the device
to avoid excessive imbalance.

1-8
 Follow the checklist for daily inspections. In the event of a system failure, do not operate this
device until the fault is cleared.

 Before starting the device, the user must be familiar with the information contained in this
Manual. The device must be inspected and repaired by qualified service personnel as required.

 If the device cannot be operated as described in the Manual, it must be inspected and
repaired by qualified service personnel as required before being put back into use.

 Handle the device with care to prevent damage or malfunction.

 When the device and its accessories will exceed their service life, they must be disposed of in
accordance with the guidelines for the management of such products and local regulations for
the management of contaminated and biohazardous goods.

 Electromagnetic fields will affect the performance of this device. Ensure that all external
equipment used near this device must comply with the appropriate EMC requirements. Mobile
phones, X-rays, and MRI equipment are all possible sources of interference, as they emit
high-intensity electromagnetic radiation.

 Make sure that the gas sources of the device always meet the relevant technical specifications.

 Prior to clinical use, the device must be properly calibrated and / or tested as described in this
Manual.

 If a system malfunction occurs during the initial calibration or test, the operation of this
device shall be stopped until qualified service personnel have eliminated the malfunction.

 In order to prevent damages to the device:

 Refer to the information provided by the cleaner manufacturer(s).

 Do not use organic, halogenated, or petroleum-based solvents, anesthetics, glass cleaners,

acetone, or other harsh cleaning agents.

 Do not use abrasive cleaners (such as steel wool or silver polish) to clean the parts.

 All liquids shall be placed away from electronic components.

 Do not allow liquid to infiltrate into the device housing.

 All used cleaning solvents must have a pH of 7.0-10.5.

 Do not immerse the O2 battery or its connector in any type of liquid.

 Dispose of the O2 battery according to the manufacturer’s specifications.

1-9
 Do not use peracetic acid or formaldehyde fumigation.

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

 Only anesthetic vaporizers with a Selectatec interlock system can be applied to this device.

 After each replacement of the anesthetic vaporizer, perform a leak test on the breathing
system circuit.

 Use cleaners with care. Excessive liquid may enter the device, thus causing damage.

 Do not subject any part of this device to high temperature and high pressure unless it is
specifically stated in this Manual that it is a high-temperature and high-pressure part. Clean
the device as specified in this Manual.

 The valve of each inhalation and respiration valve assembly on the breathing system is fragile
and must be handled with care when removing the valve seat from the valve assembly.

 If the bellows are moistened with water after cleaning, the bellows surface may have creases
that can cause the bellows to fail to unfold. Make sure to wipe out all moisture from the bellows
after cleaning.

 Do not connect any non-isolated device to the DB9 connector of this device.

 Do not connect any device to the USB port of the device except for the USB storage devices
approved by the Company.

 Do not clean the inner surface of the O2 battery.

 Do not subject the following parts to high temperature and high pressure: airway pressure
gauge, O2 battery, and flow sensor. These parts cannot withstand soaking or the heat and
pressure of high-temperature and high-pressure processing. If the breathing system is
configured with a disinfectant flow sensor, the flow sensor can be subjected to
high-temperature and high-pressure vapor disinfection.

 This device is not suitable for use in magnetic resonance (MRI) environments.

 In order to ensure accurate measurement and avoid damage to the device, use only cables and
accessories approved by the Company.

 Use the accompanying power cord. For replacement, use only power cords that meet the
specifications.

 Do not press down on the manual arm or hang a heavy weight on it. Excessive weight may

1-10
 bend or damage the manual arm.

 Since sudden release of pressure may cause injury, be careful when disconnecting the “quick
connector”.

 Avoid factors that may damage the hose assembly, including excessive bending, rolling, wear,
system pressure and temperature exceeding the hose rating, and incorrect installation.

 When removing the breathing system, care must be taken to raise and manipulate the
breathing system. Given the importance and shape of the breathing system, these operations
can be tricky.

 Do not use damaged device or accessories. During normal use, check all cables (such as AC
power cord and patient connection cable) regularly for damage. If damaged, replace it.

 The O2 ratio (FiO2) shall be monitored when using an auxiliary O2 / air flowmeter. If O2
monitoring is not performed, the concentration of O2 delivered to the patient will be unknown.

 Unlocking the casters may cause unexpected movement. The operator shall lock the casters
while using this device.

 Unmounted devices may slide off the top plate. The device shall be securely mounted on the
top plate.

 The voltage on the auxiliary socket shall be the same as the voltage of the socket into which
the device is plugged. Make sure that the voltage rating of the device plugged into the auxiliary
socket is the same as the supply voltage of this device.

 During transportation and storage of the anesthetic vaporizer, a plug shall be used to block
the inlet and outlet of the anesthetic vaporizer, thus preventing impurities from entering the
vaporizer.

 Do not use any flow outlet as a handle when moving this device. Flow outlets may be
damaged. Use the metal side bar on the unit to move the device.

Attention

 Install the device in a place convenient for observation, operation and maintenance.

 The quick opening of the cylinder valve may cause an unexpected pressure difference. Due to
potential fire or explosion hazards from O2 pressure shocks, the cylinder valve shall be opened
and closed slowly.

1-11
 If the anesthesia machine is configured with a total flowmeter, the total flowmeter will be
calibrated at 100% O2. For other gases or gas mixtures, the accuracy of the flowmeter may be
reduced.

 Changes in inlet pressure, outlet resistance, or ambient temperature may affect the accuracy
of the flow rate.

 There are regional or national regulations that apply to medical device manufacturers.

 This product does not contain any latex components.

 The operator shall be located directly in front of the device and within 4 meters of the screen
to observe the display information of the device.

 Some alarm settings of this device cannot be changed by the user.

 The figures in this Manual are for reference only. The interface may differ depending on the
system configurations and the selected parameters.

 Place this Manual near the device so that it can be easily accessed when needed.

 The software of this device is developed in accordance with the requirements of YY/T 0708,
thus minimizing the possibility of danger caused by software errors.

 This Manual describes the product according to the most complete configurations. The device
you purchased may not have certain configurations or functions.

 The device uses its own respiratory pressure monitoring during operation.

 The device uses its own respiratory pressure limiting device during operation.

 The device uses its own respiratory capacity monitoring during operation.

 The device uses its own integrity alarm system for the breathing system during operation.

 The device uses its own continuous pressure alarm during operation.

 The device uses its own O2 monitoring during operation.

 The anesthesia gas conveying equipment is used in conjunction with the anesthesia gas
monitoring module complying with YY 0601. The patient circuit and the anesthesia gas
monitoring module shall be connected through an adsorption tube.

 When using this device, the concentration of anesthetic shall be continuously monitored to
ensure that the output of the anesthetic is accurate.

 Before performing all operations and during operation, the level of the anesthetic fluid shall
1-12
 be checked. Liquid shall be added when the liquid level is below the warning line. For the
addition of anesthetic to the anesthetic vaporizervaporizer and other information, refer to the
instructions for use of the anesthetic vaporizer.

 The device system is designed with the anesthesia gas conveying equipment that complies
with YY 0635.3.

 The battery of this device is not a user-serviceable part. Only authorized service
representatives can replace the battery. If the system is not used for a long time, contact a
service representative to disconnect the battery. Dispose of the battery in accordance with
relevant local regulations. When the battery reaches its service life, dispose of it in accordance
with relevant local regulations.

 The place designated for servicing O2 equipment shall be clean, grease-free, and not used for
repairing other equipment.

 The device material does not contain any designated phthalates.

1-13
 Chapter2 Product Overview
This chapter gives an overview of the anesthesia machine and its functions.

2.1 Introduction to the Anesthesia machine Series

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-600,AX-700,AX-700A and AX-800 are applicable to
the respiratory Anesthesia and respiratory management in adult and pediatric patients during surgery,
and combine respiratory, CO2,BIS, and AG monitoring.
AX-600,AX-700,AX-700A and AX-800 can be optionally equipped with external negative pressure
suction fuction.
AX-600,AX-700,AX-700A and AX-800 features log storage and allows you to review trend data.
Log storage: Capable of storing 2000 alarm review logs, including technical alarm logs, physiologic
alarm logs.
Trend: Allowing you to view the data stored in the 60-hour trend table.

Attention
 This Manual describes the device according to the most complete configurations. The
device you purchased may not have certain configurations or functions.
 AX-700A has no auxiliary O2-supply flowmeter compared to AX-700. AX-700A is no
longer described in this Manual.

2-1
2.1.1 Anesthesia machine AX-600

Fig. 2-1 Anesthesia machine AX-600

2-2
2.1.2 Anesthesia machine AX-700

Fig. 2-2 Anesthesia machine AX-700

2-3
2.1.3 Anesthesia machine AX-800

Fig. 2-3 Anesthesia machine AX-800

2.2 Symbols used in the Manual or on the Equipment

Notes Symbol

Adjustable top light

The maximum bearing weight of the entire machine is 210kg.

The maximum bearing weight of the top plate is 20kg

2-4
 Notes Symbol

The maximum bearing weight of the workbench is 20kg

The maximum bearing weight of the top drawer is 1kg.

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

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

General warning,caution,risk of danger

High voltage warning

Flowmeter back lighting

Flow regulation

Alternating current

Battery indicator lamp

Operating indicator lamp

Battery

AUDIO PAUSED

Network port

Standby

Cylinder O2-inlet

Cylinder N2O-inlet

Cylinder AIR-inlet

2-5
 Notes Symbol

An Anesthesia-vaporizer mounting labeling

Oxygen flow meter flag

N2O flowmeter flag

Air-flow meter flag

Oxygen flush flag

CO2 module relevant flag CO2

AG module relevant flag AG

BIS module relevant flag BIS

O2、N2O、AIR

Gas supply inlet

280~600kPa

Equipotentiality

Protective grounding flag

System turn-on flag

System turnoff flag

Backup gas cylinder

Circuit removal flag

Manual drain valve flag

2-6
 Notes Symbol

CO2 absorbent canister installation and lockup flag

AGSS gas vent

PEEP gas vent

Isolation transformer

Pipeline Pipeline

Insp
Inspiratory/expiratory flag
Exp

Inspiratory/expiratory valve removal/assembling flag

Autoclavable

Not Autoclavable

Oxygen cell flag

BY-Pass flag

APL valve

Bag position/Manual ventilation

Mechanical ventilation

Material explanation

Maximum volume of Canister (carbon dioxide absorbent)

2-7
 Notes Symbol

Canister (carbon dioxide absorbent) components

Bellows cover‟s sealing ring on-the-top flag

USB port

Hot Caution!

Oxygen pressure gauge flag and backup gas-cylinder oxygen

pressure gauge flag

Nitrous oxide pressure gauge flag and backup gas-cylinder

nitrous oxide gauge flag

Air pressure gauge flag and backup gas-cylinder Air gauge

flag

Power-supply general input (220 to 240V)

Power-supply general input (100 to 127V)

Auxiliary output socket flag(220 to 240V)

Total Max Output power(Total Max.2.2A)

Auxiliary output socket flag(100 to 127V)

Total Max Output power(Total Max.4.5A)

Serial port flag

Auxiliary oxygen-supply outlet flag

2-8
 Notes Symbol

Auxiliary oxygen-supply flow meter flag

Non-protected against water IPX0

Date of manufacture

Defibrillation-proof type BF applied part

Serial Number

Complies with medical device directive 93/42/EEC

Authorised representative in the European Community

Address of manufacture

The device contains batteries and electrical

components. Consequently it cannot be
disposed of in domestic waste but must be
collected separately in accordance with local
laws and regulations.

MR Unsafe

The way up

Fragile,handle with care

Stacking limit by number

2-9
 Notes Symbol

Keep away from rain

Do not roll

center of gravity

recyclable

Environmental protection

Temperature limitation

Humidity limitation

Atmospheric pressure limitation

Refer to instruction manual/ booklet

2.3 Abbreviation of Specific Terms

Abbrev Definition
A

2-10
Abbrev Definition
AA Anesthetic
ACGO Auxiliary Common Gas Outlet
AGSS Anesthetic gas scavenging system
APL Adjustable pressure limiting
C
CO2 Carbon dioxide
Compl Compliance
CPB Cardiopulmonary bypass
CPAP/PSV Continuous Positive Airway Pressure/Pressure-su
pport ventilation
E
Et Exhale gas concentration
EtCO2 Expiratory-end tidal CO2 concentration
EtO2 Expiratory-end tidal O2 concentration
Exp Expiratory
F
Fi Inspired gas concentration
FiO2 Fraction of inspired oxygen
FiCO2 Fraction of inspired CO2
I
I:E Inspiratory:Expiratory time ratio
Insp Inspiratory
M
MAC Minimum alveolar concentration
MV Per minute ventilation
MinRate Minimum Rate

N
N2O Nitrous oxide
O
O2 Oxygen
P
P-F Pressure-Flow loop
P-V Pressure-Volume loop
Paw Airway pressure
PCV Pressure-control ventilation
2-11
Abbrev Definition
PEEP Positive end expiratory pressure
Pinsp Inspiratory pressure
Plimit Limiting pressure
Pmean Mean pressure
Ppeak Peak pressure
Pplat Plateau Pressure
ΔPps Support pressure
PRVC Pressure regulated volume control ventilation
PSVPro Pressure-support ventilation protection

R
Raw Resistance

S
SIMV-PC Synchronized intermittent mandatory ventilation-
pressure control (pressure controlled)
SIMV-VC Synchronized intermittent mandatory ventilation–
volume control (volume controlled)
SIMV-PRVC Synchronized intermittent mandatory ventilation-
Pressure regulated volume control synchronized
ventilation
T
VT Tidal volume
VTexp Expiratory tidal volume
VTinsp Inspiratory tidal volume
Tinsp Inspiration time
Trigger Inspiratory trigger
Tslope Pressure slope
Tpause Inspiratory pause
V
VCV Volume control ventilation
Vol Volume
V-F Volume-Flow loop

2-12
2.4 System Construction

2.4.1 Front

2
13

12
4
11

7
8 9 10

Fig. 2-4 Front View of Anesthesia machine AX-600

1 Ventilator/monitor display 8 ACGO switch

2 Flow control(Mechanical Flowmeter) 9 Oxygen flush button

3 Auxiliary O2 supply flowmeter 10 System switch

4 Plug-in module area 11 Gas cylinder pressure gauge (optional)

5 Breathing system 12 Pipeline pressure gauge

2-13
 6 Oxygen cell plugOxygen sensor 13 Anesthesia Vaporizer

7 Castor brake

The Control Functions to be implemented through the Front of Anesthesia machine AX-600：
Item Name Notes
Turn anticlockwise the control knob to 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 (Mechanical
Flowmeter)

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:
10 System switch

Push the „O2 +‟ oxygen flush Button to supply high-flow oxygen to the
breathing system.

9 Oxygen flush button

Depress at least 2 castor brake downward by foot, the anesthesia machine may
be braked, as shown in the figure below:

7 Castor brake

2-14
1 13
2
3
12
4
11
5

9 10

Fig. 2-5 Front View of Anesthesia machine AX-700

1 Ventilator / monitor display 8 Central brake

2 Flow control(Electronic Flowmeter) 9 Oxygen flush button

3 Auxiliary O2 supply flowmeter 10 System switch

4 Plug-in module area 11 Gas cylinder pressure gauge

5 Breathing system 12 Pipeline pressure gauge

6 ACGO switch 13 Anesthesia Vaporizer

7 Oxygen sensor end cap

2-15
The Control Functions to be implemented through the Front of Anesthesia machine AX-700：
Item. Name Notes
Turn anticlockwise the control knob to 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. (Electronic
Flowmeter)

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:
10. System switch

Push the „O2 +‟, oxygen flush button to supply high-flow oxygen to the
breathing system.

oxygen flush
9
button

Press the bottom end of the central brake pedal with your foot to , to

apply brake to the anesthesia machine; press the upper end of the central

brake pedal to to release the brake (see the figure below). After the

brake is released, the anesthesia machine can be moved.

8 Central brake

2-16
1
14
2

4 13
12
5

11

9 10

Fig. 2-6 Front View of Anesthesia machine AX-800

1 Ventilator / monitor display 8 Central brake

2 Flow control(Electronic Flowmeter) 9 Oxygen flush button

3 Auxiliary O2 supply flowmeter 10 System switch

4 module area 11 Vacuum suction system

5 Breathing system 12 Gas cylinder pressure gauge

6 ACGO switch 13 Pipeline pressure gauge

7 Oxygen sensor end cap 14 Anesthesia Vaporizer

2-17
The Control Functions to be implemented through the Front of Anesthesia machine AX-800：
Item. Name Notes
Turn anticlockwise the control knob to 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 (Electronic
Flowmeter)

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:
10 System switch

Push the „O2 +‟, oxygen flush button to supply high-flow oxygen to the
breathing system.

oxygen flush
9
button

External vacuum suction:

It consists of a pressure gauge, vacuum regulating gears and a vacuum
adjustable knob, which can be set to [FULL], [OFF] or [REG]. [FULL]
indicates that the vacuum suction device operates with continuous
Vacuum suction maximum pressure, and thus the regulation knob does not function. [OFF]
11
system indicates that the vacuum suction device does not function after turning off
the vacuum. [REG] indicates that it is able to regulate the pressure of the
vacuum suction device through the vacuum regulation knob for operation.
Rotate the vacuum regulation knob counterclockwise to increase the
vacuum. Rotate the vacuum regulation knob clockwise to decrease the
2-18
 vacuum. The pressure gauge is used for displaying the pressure.

Press the bottom end of the central brake pedal with your foot to , to

apply brake to the anesthesia machine; press the upper end of the central

brake pedal to to release the brake (see the figure below). After the

brake is released, the anesthesia machine can be moved.

8 Central brake

2-19
2.4.2 Back

1 2

11

10
4

Fig. 2-7 The Back of Anesthesia machines AX-600 and AX-700

1 Equal-potential binding post 7 Anesthetic Gas Scavenging System

2 Communication interface 8 Liquid collection bottle
3 Hook 9 Vacuum suction system
4 Port of backup gas cylinder 10 Pipeline gas connector
Power-supply auxiliary output-socket General supply socket and its system circuit
5 11
disconnecting switch disconnecting switch
6 Power-supply auxiliary output socket

2-20
 1 2

10

6
7

Fig. 2-8 The Back of Anesthesia machines AX-800

1 Equal-potential binding post 6 Anesthetic Gas Scavenging System

2 Communication interface 7 Liquid collection bottle

3 Hook 8 Port of backup gas cylinder

4 Power-supply auxiliary 9 Pipeline gas connector

output-socket disconnecting

2-21
 switch

5 Power-supply auxiliary output 10 General supply socket and its system

socket circuit disconnecting switch

2.5 Introduction to the Machine Components

Warning

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

 Never use antistatic breathing 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
10 12

9 13
8 14
7

6 15

4
3

2 1
Fig. 2-9 Breathing System of Anesthesia machine Series

1 Expiratory flow port 9 Pressure gauge (airway)

2-22
2 Canister (carbon dioxide absorbent) 10 Manual bag port

3 Canister release 11 Bellows assembly (mechanical ventilation)

4 Manual drain valve 12 Gasbag support arm

5 Leak test plug 13 Manual/mechanical ventilation switch

6 Breathing tube hook 14 Inspiratory check valve

7 Expiratory check valve 15 Inspiratory flow port

8 APL (adjustable pressure limiting) valve

No. Item Notes

In manual/spontaneous 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/spontaneous (gasbag) or volume control (ventilator).

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

mechanical control switch to its position “Mechanical Control” ( ).

2-23
 Attention
 The bellows cover is a transparent cover with scale marks from 300 to 1500ml. These scale marks
are for reference only. VT shall be read from the user interface. The delivered VT is the sum of
the bellows displacement and the fresh gas flow.
 The values on the APL valve and the airway pressure gauge are for reference only. Calibrated
patient airway pressure is displayed on the user interface.

2.5.2 Structural Composition of AGSS

7 2

6
3

5
4

No. Notes Description

The inlet of the gas emitted by the breathing
1 Waste gas exhaust nozzle connector system. The exhaust gas transmission hose
connects the inlet with the exhaust gas

2-24
 discharge port to transfer the discharged gas.
Head to the hospital‟s exhaust gas treatment
2 AGSS waste gases outlet
system.
Outer cone connector for hose of transfer /
3
system
4 Pressure Compensation Port Pressure release device
5 Main body of AGSS system /
Indicate the exhaust flow, which can be
adjusted by rotating the flow adjustment knob
6 Float (red)
until the float is located between the Min and
Max scales.
Adjust the flow in AGSS clockwise or
7 Flow regulation knob counterclockwise until the float is located
between the Min and Max scales.

2.5.3 Vacuum suction device

Vacuum suction refers to the suction device with vacuum generated by the venturi device. It mainly
consists of negative pressure generator, negative pressure regulating valve, negative pressure indicator,
overflow cup, filter, liquid collecting bottle and suction tube, and is mainly used in the collection of medical
waste liquid. It is designed with overflow protection function to prevent backflow of fully collected waste so
as to ensure the safety of the gas pipeline. The schematic drawing is as follows.

2-25
 Switch Vacuum generator
Air supply Waste gas

Overflow valve

Change-over valve

Regulating Valve

Air resistor
Overflow bottle Liquid collection bottleLiquid collection bottle

Pressure gauge

Fig. 2-10 Schematic Drawing of Vacuum Suction

4
3 5 6

Fig. 2-11 Vacuum suction device

Item Name Note

1 Liquid collection Used to collect waste medical liquid
bottle
2-26
2 Filter Used to filter water vapor and impurities.
3 Overflow Used to prevent backflow of fully collected waste so as to ensure the
protection safety of the gas pipeline.
4 Negative Used to indicate negative pressure value.
pressure gauge
5 Negative Used to adjust the pressure of the vacuum suction device
pressure
adjustment
knob
6 Selection Used to switch the work mode of the vacuum suction device. It may be
switch set as FULL, OFF or REG. "FULL" indicates that the vacuum
suction device operates at a continuous maximum pressure and the
adjustment knob does not work. "OFF" indicates that the negative
pressure is off and the vacuum suction device does not work. "REG"
indicates that the vacuum adjustment knob can be used to adjust the
operation of the vacuum suction device. Rotate the vacuum adjustment
knob counterclockwise to increase the negative pressure. Rotate the
vacuum adjustment knob clockwise to decrease the negative pressure.
7 Suction tube Used to transfer waste medical liquid. The suction tube has an inner
diameter of Φ8 (5/16 "). The suction tube is inserted directly into the
interface.

Note

 Refer to the user’s manual supplied with the external vacuum suction system for specific
information.

Warning

 The vacuum suction system shall only be operated by trained personnel.

2.5.4 Auxiliary Common Gas Outlet (ACGO)

1. ACGO Mode:
When ACGO cover is opened and the anesthesia machine is set to its position ACGO, fresh gas
2-27
 flow passes through the ACGO outlet in the front of the machine, and the interface is changed into
ACGO mode.
Do not use external ventilator on the ACGO. Do not use the ACGO to drive an external ventilator.

2. Non-ACGO mode:
Mechanical ventilation or manual/spontaneous ventilation for patient may be achieved by the
breathing system.

3. When ACGO offers fresh gas to respiration apparatus:

 Mechanical ventilation is disabled.
 Pressure gauge, Manual/mechanical ventilation switch, APL valve and gasbag support column
are spontaneous of external circuit devices.

 Volume and pressure monitoring and control functions are disabled.

 Do not use external ventilator on the ACGO.
 Do not use the ACGO to drive an external ventilator.
 Flow control system is valid.

2.5.5 Anesthesia Vaporizer

AX-600,AX-700,AX-700A and AX-800 designed to work with Draeger Series Anesthesia Vaporizers
for non-flammable anesthetic 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.

Note

2-28
  The "Draeger" described in this article is the English translation of "Dräger".

2.5.6 Control of Anesthesia Ventilator

2.5.6.1 Optional Functions in Ventilation Mode

Various ventilation modes may be selected and configured for anesthesia machine

 VCV

 SIMV-VC

 PCV

 SIMV-PC

 CPAP/PSV

 PRVC

 SIMV-PRVC

 PSVPro

 Manual/Spont

2-29
2.5.6.2 Control Panel
The control panel components of an anesthesia ventilator include:
 Buttons

 Touch-control display screen

 Control knobs

1 2 3 4 5 6 7

20

8
19

10

11

18 17 16 15 14 13 12

Fig. 2-12 Control Panel of Anesthesia machine

1 Alarm indicator 11 Timer

2 Patient type 12 Control knob
3 Patient information 13 Standby button
4 Alarm Message Area 14 AUDIO PAUSED button
5 Alarm sound pause icon 15 Ventilations Mode and Setting Parameters Area
6 System Date and Time 16 Battery status indicator
7 Main Power Supply and Battery Status Icon 17 Working indicator

2-30
8 Monitoring values of ventilator 18 AC power indicator
9 Area for monitoring of CO2 and O2 19 Area for monitoring of Anesthetic gases
concentration
concentration
10 System prompt message area 20 Current Ventilation Mode

Caution
 When anesthesia machine is restarted, patient type before the last shutdown will be
reserved.

2.5.7 Flowmeter

2.5.7.1 Total Flowmeter

1 Total flowmeter

Caution
 The flow meter shall be marked with pure oxygen for application. In case of using gas
mixture, the accuracy will be affected.

2-31
2.5.7.2 Auxiliary O2 Supply Flowmeter

1
1

Fig. 2-13 Auxiliary O2 Supply Flowmeter and Its Control

1 Auxiliary O2-supply flowmeter control knob

2 Auxiliary O2-supply flowmeter outlet nozzle

Caution
 Turn anticlockwise the flow control knob to increase the oxygen flow, or turn it clockwise to
reduce the flow.

2.5.8 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 is applicable to connection of all medical-use electrical rooms and connection
of at least one piece of medical-use electrical equipment to one piece or pieces of
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 supply, the equipment connected to the auxiliary

2-32
 output power supply shall fall within the voltage/current specifications of the auxiliary output
power supply. The equipment connected to the auxiliary output power supply 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
equipment.

 If your anesthesia machine is not equipped with an isolation transformer, the equipment
connected to the auxiliary output power supply may increase the leakage current. The
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.

2.5.9 Dovetail groove

Dovetail groove is a type of mechanical structure that works with guide rails for
guiding and supporting, and it may be used to connect other equipment
such as monitoring equipment etc.

Warning

 With standard configuration, anesthesia machine may remain stable when it is inclined by
10°. Do not hang any articles from both sides of an anesthesia machine for fear of off-balance
hazard.

2.5.10 Operation ceiling lamp

Located below the top plate, it illuminates the workbench, allowing users to read the settings on the dial of
the anesthetic vaporizer in a dark room. The brightness of the light can be adjusted by adjusting the operation
ceiling lamp regulator below the top plate.

2.5.11 Flowmeter lighting

The lighting switch is located at the bottom left of the top plate, allowing users to read the scale display of the
auxiliary O2 supply flowmeter, auxiliary air flowmeter, and total flowmeter in a dark room.
2-33
2.5.12 Workbench ergonomics

This device is a full-featured anesthesia delivery workstation. The protruding edge of its stainless steel
workbench can prevent items placed on it from rolling out or sliding off the edge of the workbench. The
wraparound armrests on the workbench can better position the device. Two large drawers are provided for
storing items. Dovetail rails on both sides of the device are used to mount standard accessory arms for
monitors and other equipment. In addition, non-slip foot pedals is available.

2.5.13 Breathing system hook

The hook on the side of the breathing system is used to suspend the breathing circuit.

2.5.14 Battery

The anesthesia machine is equipped with an internal rechargeable battery to ensure that the system can
operate normally in the event of a power outage. When the device is connected to an AC power supply, the
battery can be charged regardless of whether the device is turned on or not. In the event of a sudden power
outage, the system will automatically switch to internal battery power without interrupting the operation.
When the AC power supply recovers within a specified time, the battery starts to charge, and the system stops
using the battery while automatically switching to the AC power supply to ensure the continuous operation of
the system.
If the battery power is too low, it will cause the power supply to malfunction. The device will trigger an
advanced alarm and display the alarm information in the technical alarm area. In this case, use an AC power
supply to supply power to the anesthesia machine to get it back to work and charge the battery.

2.5.15 Serial Port

The symbol “ ” marked on back cover of the equipment indicates the serial port of the
equipment. That port is designed only for factory maintenance to be performed by the Company.

2.5.16 USB Port

The symbol “ ” on the back cover of the equipment indicates the USB port. This port is
used for data output and software update (by the Company).

2.5.17 Network Port

2-34
 The symbol “ ” on the back cover of the equipment 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 system 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).

2.5.18 Equal-potential Grounding

Equal-potential grounding 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 equipment, 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 grounding lead.

Check whether or not the equipment is kept in good working order prior to each operation.

Warning

 If the protective ground system works unstably, the equipment shall be powered by internal
power supply.

2-35
 Chapter3 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 anesthetics, 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.

 Do not place the power plug used to disconnect the monitor from grid power supply in a
position not easily accessible by the operator.

 Before using the device on the patient, make sure that the device is installed correctly and
intact.

 The operator shall not touch the patient and the charged equipment outside the device at the
same time.

 The input / output signal port can only be connected with the specified external device.

3.1 Turn on the system

1. Connect the gas source to ensure that the gas source has enough pressure (gas source pressure
is between 280kPa and 600kPa).

2. Plug the power cord into a power socket. Turn on the main power switch on the back of the
device. The AC power indicator lights up when connected to AC power supply. If the battery power is
low, the battery is charging.

3. Set the system switch to ON “ ” state and turn on the device.

a) The alarm indicator flashes once in red-yellow order, and then the buzzer sounds a “beep”.

b) The system enters the ON state. The control panel screen displays the Comen LOGO.

c) The system automatically performs a series of self-tests. After the self-tests are completed, the
self-test results are displayed.

After the completion of self-tests, enter the next step “Leak in vent mode”.
3-1
 d) According to the prompt on the interface, select “Start” for “Leak in vent mode”. Enter “Leak
in bag mode” in case of passing the test.

If the test fails, refer to “4.5.2Breathing System Leak Test in Mechanical Ventilation Mode” for
retesting.

e) According to the prompt on the interface, select “Start” for “Leak in bag mode”. Enter the
“Standby” interface in case of passing the test. At this time, after selecting the patient type “Adult” or
“Child”, select “Ventilation Start” to enter the user interface.

If the test fails, refer to “4.5.3Breathing System Leak Test in Manual Ventilation Mode” for retesting.

Warning
 To run the equipment for patients, make sure 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 power 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 anesthetization. When the AC power
supply resumes 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 level is too low,
anesthesia machine may give out a high-level alarm, and display the alarm message [Low
Battery Voltage] 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
3.1.1 Patient type
1. Enter the standby screen, can set the patient type as [Adult] or [Child].
2. Click [Adult] or [Child] button to quickly switch the patient type and the default parameter settings for
the patient type.

Caution

 The patient type is not optional in ventilation mode.

3.1.2 Set Patient Information

1. Select the [Patient Info] soft button in the upper left corner of the main screen,and display
[Name],[Sex],[Bed NO.],[Age],[Height],[Weight] patient information parameter options in the
open menu.
2. If there is no operation,the patient information window will closed after 30s.After setting the
patient information,click to confirm the current operation.

3-3
3.2 Configure Volume for Alarms, Prompts and Key Operations
1. Set the system switch to its status ON “ ”.

2. On the screen, select [Alarm] menu → Access the [Sound] menu.

3. Set volume in grade “1-8” respectively for [Alarm Sound Volume] 1,,set volume in grade
“0-7” respectively for [Indicate sound Volume] 2, [Key sound Volume] 3. 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.

Fig. 3-1 Interface for Configuring Sound

3-4
Note
 1: The alarm volume is set to adjust the volume of all high, medium, and low priority audible
alarms.
 2: The prompt volume is the volume of the prompt message that appears in the alarm prompt
area.
 3: The button volume is the volume of the sound produced by touching the soft buttons on the
operation interface via a touch screen.

3.3 Turn on/off Volume Alarm Switch

1. Set the system switch to its status “ ”.

2. Set the manual/mechanical ventilation switch to manual position, the screen displays
[ Manual/Spont].

3. Select [Alarm] ,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.

Fig. 3-2 Manual/Spont Alarm Menu

3.4 Open, close the extracorporeal circulation switch

In non-automatic circuit mode:

1. Set the system switch to ON “ ”.

2. Rotate the APL valve control knob to adjust the pressure in the breathing system to the proper
range.
3. Set the manual/mechanical ventilation switch to manual position, the screen displays
[ Manual/Spont].
4. At the user interface, select the capacity [Manual /Spont] menu→Enter [CPB] menu on the lower
part of the screen.
5. Press and turn the "Control Knob" key to switch between [ON] and [OFF].
6. Select [ON] or [OFF] and then press the "Control Knob" to confirm the current option.
7. Rotate the "Control" button to return to the [Manual/Spont] menu and go back to the previous
menu.
In mechanical ventilation mode, system sets the [CPB] to [OFF] automatically, and the user

3-5
 cannot modify it.

Warning

 During [CPB] 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 VTexp, Low VTexp,High MV, Low MV.

3.5 Set the High/Low Alarm Limits

1. Set the system switch to its status “ ”.

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

Fig. 3-3 High/Low Alarm Limit Interface

Note

 Note 1: See [Alarm setting] given in relevant chapter for details of High/low alarm limits for
parameters of [ventilator] ,[AG],[CO2]and[BIS].

3.6 Vacuum suction operation

3-6
Note

 Please refer to the user manual supplied with the external vacuum suction system for
operation information on the external vacuum suction system.

3.6.1 Turn on the external vacuum suction device

1. According to 5.9.1 Installation of external vacuum suction, assemble an external vacuum suction
device to an anesthesia machine;
2. Press the driving gas switch to the OFF position; turn the negative-pressure gear switch to the OFF
position as well;
3. Rotate the negative-pressure adjustment knob counterclockwise to the minimum position until it
can no longer be rotated;
4. Open the O2 source, and confirm that the gas source pressure is within the applicable range of the
external vacuum suction (280-550kPa);
5. When the gas source pressure is appropriate, pull the driving gas switch to the ON position;
6. Block the patient end of the suction tube, and turn the negative-pressure gear switch to the FULL
position; observe whether the reading on the negative pressure gauge can reach 60kPa;
7. Turn the negative-pressure gear switch to the REG position; slowly rotate the negative-pressure
adjustment knob clockwise; observe whether the reading on the pressure gauge changes with the
adjustment; confirm that the negative pressure can be adjusted to 60kPa or above, and that the pressure
can remain steady when not adjusting;
8. Confirm that there is no fault. Adjust the negative pressure to the desired pressure for use.

3.6.2 Turn off the external vacuum suction device

1. After use, rotate the negative-pressure adjustment knob counterclockwise until the negative
pressure value returns to zero;
2. Turn the negative-pressure gear switch to the OFF position, and press the driving gas switch to the
OFF position. The vacuum suction is then completely shut down.

Warning

 Please keep vacuum suction switch at OFF when the vacuum suction device is not in use.

3-7
3.7 Set Parameters of Ventilator
Parameters of ventilator are configured mainly through Control Knob and touch screen operations.
When parameter settings are changed, bubble box appears for the corresponding
parameter,indicating the current parameter range(or the correlation equation of the
parameter).When switching modes. When switching modes, 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

Warning

 Click on the system default, vent mode setting restored to system defaults.

3.7.1 Set Tidal Volume

1. Select menu of [VCV] / [SIMV-VC] /[PRVC] / [SIMV-PRVC] mode→ [VT] .

2. Select the parameter via the control knob or touch control, and rotate the knob to set [VT] to the
appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.2 Set Respiratory Rate

1. Select the menu of ventilation mode→ [Rate] .

2. Select the parameter via the control knob or touch control, and rotate the knob to set [Rate] to
the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

Note
3-8
  [Rate] can be configured in [VCV],[SIMV-VC],[PRVC],[SIMV-PRVC],[PCV],[SIMV-P
C], and [PSVPro] .

3.7.3 Set the Minimum Respiratory Rate

1. Select the menu of [CPAP/PSV] mode → [MinRate] .

2. Select the parameter via the control knob or touch control, and rotate the knob to set [MinRate]
to the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.4 Set Inspiratory: Expiratory Time Ratio

1. Select the menu of [VCV] [PCV] or [PRVC] mode→ [I:E] .

2. Select the parameter via the control knob or touch control, and rotate the knob to set [I:E] to the
appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.5 Set Inspiratory Time

1. Select the menu of [SIMV-VC]/[SIMV-PC]or[SIMV-PRVC] mode→[Tinsp],or

[PSVPro]→[Extra Setting] →[Tinsp].
2. Select the parameter via the control knob or touch control, and rotate the knob to set [Tinsp] to
the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.6 Set Inspiratory Pause

1. Select the menu of [VCV] or [SIMV-VC] → [Tpause] .

2. Select the parameter via the control knob or touch control, and rotate the knob to set [Tpause]
to the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.7 Set Inspiratory Pressure

1. Select the menu of [PCV] or [SIMV-PC] mode→ [Pinsp] , or [PSVPro]→[Extra Setting]

→[Pinsp].
3-9
 2. Select the parameter via the control knob or touch control, and rotate the knob to set [Pinsp] to
the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.8 Set Support Pressure

1. Select the menu of [SIMV-VC] , [SIMV-PC] , [PSVPro] , [SIMV-PRVC] or [CPAP/PSV]

mode → [ΔPps] .
2. Select the parameter via the control knob or touch control, and rotate the knob to set [ΔPps] to
the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.9 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
the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.10 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
the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.11 Set Pressure Slope

1. Select the menu of [PCV] , [SIMV-PC] , [PSVPro] , [SIMV-PRVC] , [SIMV-VC] or

[CPAP/PSV] mode → [Tslope].
2. Select the parameter via the control knob or touch control, and rotate the knob to set [Tslope] to
the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.12 Set Trigger Window

1. Select the menu of [SIMV-VC] , [PSVPro], [SIMV-PRVC] or [SIMV-PC] mode → [Extra

3-10
 Setting] → [Trig Window] .
2. Select the parameter via the control knob or touch control, and rotate the knob to set [Trig
Window] to the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.13 Set Inspiratory Triggering

1. Select the menu of [SIMV-PC] , [SIMV-PRVC] or [SIMV-VC] mode → [Extra Setting] →

[Trigger], or select the menu of [CPAP/PSV] , [PSVPro] mode → [Trigger] .
2. Select the parameter via the control knob or touch control, and rotate the knob to set [Trigger]
to the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.14 Set Stop level

1. Select the menu of [CPAP/PSV], [SIMV-PC],[SIMV-VC] or [SIMV-PRVC] mode → [Extra

Setting] → [Exp%], or select the menu of [PSVPro] mode → [Exp%] .
2. Select the parameter via the control knob or touch control, and rotate the knob to set [Exp%] to
the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.15 Set Apnea Pressure

1. Select the menu of [CPAP/PSV] mode → [Extra Setting] → [ΔPapnea].

2. Select the parameter via the control knob or touch control, and rotate the knob to set [ΔPapnea]
to the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.16 Set Apnea Respiratory Ratio

1. Select the menu of [CPAP/PSV] mode → [Extra Setting] → [Apnea.IE].

2. Select the parameter via the control knob or touch control, and rotate the knob to set [Apnea.IE]
to the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.17 Set Apnea Time

1. Select the menu of [PSVPro] mode →[Apnea Ti].

2. Select the parameter via the control knob or touch control, and rotate the knob to set [Apnea Ti]
3-11
 to the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.7.18 Set Exit Backup

1. Select the menu of [PSVPro] mode→ [Extra Setting] →[Exit Backup].

2. Select the parameter via the control knob or touch control, and rotate the knob to set [Exit
Backup] to the appropriate value.
3. Confirm the parameter setting via the control knob or touch control.

3.8 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 80601-2-13 and YY 0635.2。

3.8.1 Manual/Spont Mode

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

3-12
 Fig. 3- 1

Note

 Make sure Manual/Spontaneous mode is always available when this device is used on
patients.

3.8.2 Mechanical Ventilation Mode

3.8.2.1 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] → [VT] .
4. Enter the setting mode through the “Control Knob” or touch screen operation. Rotate the “Control
Knob” to set a proper value for [VT] , 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 Manual/mechanical ventilation switch to [Mechanical Control] position.
8. If necessary, press the “Oxygen flush” button to inflate bellows.

3-13
 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.

 Ventilator mode settings will restore to system defaults after anesthesia machine shutdown.

3.8.2.2 Select Mechanical Ventilation Mode

Ventilation 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 8 modes for mechanical ventilation:
 VCV
 SIMV-VC
 PCV
 SIMV-PC
 PRVC
 SIMV-PRVC

 CPAP/PSV
 PSVPro

3.8.2.2.1 Select VCV Ventilation Mode

1. Select [VCV] tab→ set up parameters like [VT], [Rate] .
2. Select [VCV] tab→ [Confirm] to start the VCV mode.
3. At this time, the current mode [VCV] is displayed at the left top of the screen.

3.8.2.2.2 Select SIMV-VC Ventilation Mode

1. Select [SIMV-VC] tab → set up parameters like [VT] , [Rate] .
2. Select [SIMV-VC] tab → [Confirm] to start the SIMV-VC mode.
3. At this time, the current mode [SIMV-VC] is displayed at the left top of the screen.

3-14
3.8.2.2.3 Select PCV Ventilation Mode
1. Select [PCV] tab → set up parameters like [Pinsp] , [Rate] .
2. Select [PCV] tab → [Confirm] to start the PCV mode.
3. At this time, the current mode [PCV] is displayed at the left top of the screen.

3.8.2.2.4 Select SIMV-PC Ventilation Mode

1. Select [SIMV-PC] tab → set up parameters like [Pinsp] , [Rate] .
2. Select [SIMV-PC] tab → [Confirm] to start the SIMV-PC mode.
3. At this time, the current mode [SIMV-PC] is displayed at the left top of the screen.

3.8.2.2.5 Select PRVC Ventilation Mode

1. Select [PRVC] tab → set up parameters like [VT] , [Rate] .
2. Select [PRVC] tab → [Confirm] to start the PRVC mode.
3. At this time, the current mode [PRVC] is displayed at the left top of the screen.

3.8.2.2.6 Select SIMV-PRVC Ventilation Mode

1. Select [SIMV-PRVC] tab → set up parameters like [VT], [Rate] .
2. Select [SIMV-PRVC] tab → [Confirm] to start the SIMV-PRVC mode.
3. At this time, the current mode [SIMV-PRVC] is displayed at the left top of the screen.

3.8.2.2.7 Select CPAP/PSV Ventilation Mode

1. Select [CPAP/PSV] tab → set up parameters like [ΔPps] , [Rate] .
2. Select [CPAP/PSV] tab → [Confirm] to start the CPAP/PSV mode.
3. At this time, the current mode [CPAP/PSV] is displayed at the left top of the screen.

3.8.2.2.8 Select PSVProVentilation Mode

1. Select [PSVPro] tab → set up parameters like [ΔPps], [Trigger] .
2. Select [PSVPro] tab → [Confirm] to start the PSVPro mode.
3. At this time, the current mode [PSVPro] is displayed at the left top of the screen.

3-15
3.8.2.3 Introduction to Ventilation Modes

3.8.2.3.1 VCV Mode

Paw Tresp
（Rate） Ppeak
Pplat

Peep

Flow Ti Te
Tpause

Fig. 3-5 Waveform of VCV Mode

Under the volume controlled VCV mode, a preset tidal volume will be provided. According to the
preset [VT] , [Rate], [Tpause]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
breathing circuit system and the influence of the fresh airflow can be compensated.
Generally, under this mode, a constant flow is delivered during the inspiration phase, with the
pressure increasing in the lungs; the flow is exhaled fastly in the expiration phase, and the
pressure inside the lungs drops rapidly. By setting [Tpause] , the gas distribution in the patient‟s
lungs can be optimized.
When the airway pressure exceeds the limit pressure, the ventilator will provide alarms and switch
to expiration.
Setting [PEEP] (Positive End-Expiratory Pressure) to improve the expiratory-end CO2 discharge
and increase oxygenation during the respiratory process.

Settings of VCV Mode:

 VT
 Rate
 I:E
 Tpause
 Plimit
 PEEP

3-16
3.8.2.3.2 SIMV-VC Mode

SIMV Circle
Paw
Trigger Window Out of Trigger Window
Ppeak Pplat Psupp

Peep
Trigger
Ti （Pressure Trigger）
Flow Exp%
Tpause

Trigger
No Ventilation（Flow Trigger）
In Trigger Window

Fig. 3-6 Waveform of SIMV-VC Mode

Under the SIMV-VC mode, a preset tidal volume will be delivered to a patient at a preset [Rate]. In
the respiratory interval (trigger window), the patient conducts spontaneous respiration at patient‟s
respiratory rate and tidal volume.
The ventilator waits for the patient‟s spontaneous respiration as per the preset interval. [Trigger]
includes flow triggering or pressure triggering. If the spontaneous respiration reaches the threshold of
[Trigger] in the [Trig Window], the ventilator uses the preset tidal volume and inspiratory time to
deliver fresh gas synchronously, or it will conduct mechanical ventilation as per the preset clinical
parameter of [Rate].
Under this mode, spontaneous respiration can obtain the ventilator pressure to support ventilation.
Thus the patient can overcome the resistance in the patient‟s circuit system and the artificial airway, so
as to conduct ventilation with the preset support pressure.

Settings of SIMV-VC Mode

 VT
 Rate
 Tinsp
 Tpause
 △Pps
 Tslope
 Plimit
 PEEP
 Trig Window
 Trigger
 Exp%

3-17
3.8.2.3.3 PCV Mode

Tresp
(Rate)
Paw Pinsp

Peep

Ti Te
Flow

Fig. 3-7 Waveform of PCV Mode

Under the PCV mode, a constant inspiratory pressure will be provided. According to the preset [Rate]
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 airway pressure 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 CO2 discharge and
increase oxygenation during the respiratory process.
Settings of PCV Mode:
 Pinsp
 Rate
 I:E
 Tslope
 Plimit
 PEEP

3-18
3.8.2.3.4 SIMV-PC Mode

SIMV Circle
Paw
Trigger Window Out of Trigger Window
Pinsp Psupp

Peep
Trigger
Ti
（Pressure Trigger）
Flow Exp%

Trigger
No Ventilation（Flow Trigger）
In Trigger Window

Fig. 3-8 Waveform of SIMV-PC Mode

Under the SIMV-PC mode, the ventilator use a preset [Pinsp] to conducts ventilation for a patient at a
preset [Rate]. In the respiratory interval (trigger window), the patient conducts spontaneous respiration
at patient‟s respiratory rate and tidal volume.
The ventilator waits for the patient‟s spontaneous respiration as per the preset interval. [Trigger]
includes flow triggering or pressure triggering. If the spontaneous respiration reaches the threshold of
[Trigger] in the [Trig Window] , the ventilator will use the preset inspiratory pressure and inspiratory
time to deliver fresh air synchronously, or it will conduct mechanica lventilation as per the preset
clinical parameter of [Rate] .
Under this mode, spontaneous respiration can obtain the ventilator pressure to support ventilation.
Thus the patient can overcome the resistance in the patient‟s circuit system and the artificial airway, so
as to conduct ventilation with the preset support pressure.
Settings of SIMV-PC Mode:
 Pinsp
 Rate
 Tinsp
 Tslope
 ΔPps
 Plimit
 PEEP
 Trig Window
 Trigger
 Exp%

3-19
3.8.2.3.5 PRVC Ventilation Mode

Paw VC PC

Pplat

Peep

Ti Te
Flow
25% Tpause

Fig. 3-9 Waveform of PRVC Mode

The PRVC mode is a controlled ventilation mode in which pressure regulates volume control.
In the PRVC mode, the first respiratory cycle is a trial ventilation for volume control, and trial
ventilation is performed according to preset [VT], [Rate], [I:E] and the default 25% inspiratory pause.
The measured plateau pressure during the inspiratory pause is used as the inspiratory pressure value for
the next respiratory ventilation cycle. Starting from the second respiratory cycle, the inspiratory pressure
value, [Tslope], [Rate], and [I:E] are used for pressure control ventilation. During ventilation,
inspiratory pressure will be automatically adjusted according to the characteristics of the patient's lungs,
in order to achieve transfer of the target tidal volume.
When the adjusted suction pressure reaches the preset [limit pressure], the system will provide alarm and
change to expiration.
The settings of pressure regulating volume control ventilation mode inlude:
 VT
 Rate
 I:E
 Plimit
 PEEP
 Tslope

3-20
3.8.2.3.6 SIMV-PRVC Ventilation Mode

Paw SIMV Circle

Trigger Window Out of Trigger Window
Pplat Psupp
Pplat

Peep
Trigger
Ti Te （Pressure Trigger）
Flow Exp%
25%Tpause

Trigger
（Flow Trigger）
No Ventilation
In Trigger Window

Fig. 3-10 Waveform of SIMV-PRVC Mode

SIMV-PRVC is a mode in which ventilation is delivered to a patient with synchronized intermittent

command and pressure regulated volume control.
In the SIMV-PRVC mode, the ventilator waits for the patient to inspire at a specified time interval. The
inspiratory trigger depends on the preset [Trigger] threshold. The inspiratory trigger can be set to the
flow trigger or pressure trigger mode. If the inspiratory trigger threshold is reached within the [Trig
Window] set time, the ventilator simultaneously deliver PRVC control ventilation according to the
preset [VT], [Rate], [Tinsp], and [Tslope]. If the patient does not inspire in the trigger window, the
ventilator sends PRVC control ventilation to the patient when the trigger window ends. During the
pressure control ventilation process, the inspiratory pressure will be automatically adjusted according to
the lung characteristics of the patient to achieve the transfer of the target tidal volume.
The first PRVC ventilation is a trial volume control ventilation, and the subsequent PRVC ventilation is
pressure controlled ventilation with the plateau pressure measured at the trial ventilation stage as the
control pressure.
In the SIMV-PRVC mode, spontaneous breathing outside the trigger window can obtain pressure support
ventilation to help the patient overcome the resistance of the patient's circuit system and artificial airway
and perform ventilation according to the preset [ΔPps].
The settings of pressure adjustment and control synchronization ventilation mode:
 VT
 Rate
 Tinsp
 Plimit
 ΔPps
 Tslope
 PEEP
 Trig Window

3-21
  Trigger
 Exp%

3.8.2.3.7 CPAP/PSV Mode

Paw Min Rate

Psupp Papnea

Peep
Trigger
（Pressure Trigger）
Flow Exp%

Trigger
（Flow Trigger） No Ventilation

Fig. 3-11 Waveform of CPAP/PSV Mode

CPAP/PSV mode is an auxiliary respiratory ventilation mode.

Under this mode, the ventilator conducts ventilation at the preset [MinRate] . In the preset
interval, if the spontaneous respiration reaches the level of [Trigger] , the ventilator starts to
deliver gas to increase the pressure in the airway to the preset [ΔPps] quickly, and then maintain
the pressure at the same level. After the spontaneous inspiratory flow reduces to [Exp%], the
ventilator stops delivering gas and the patient starts to exhale; If the spontaneous respiration does
not reach the triggering level, the ventilator will conduct mandatory ventilation for once with the
[ΔPapnea] ,[ Apnea.IE] , ensuring the minimum ventilation volume for the patient.
Under this mode, the tidal volume is the monitored value, which depends on various factors like
the inspiratory force of the patient, preset [ΔPps] level, the compliance and the resistance between
the patient and the whole system of the ventilator, etc.
Settings of CPAP/PSV Mode:
 ΔPps
 MinRate
 Trigger
 Tslope
 Plimit
 PEEP
 Exp%
 ΔPapnea
 Apnea.IE

3-22
3.8.2.3.8 PSVPro Ventilation Mode

Paw SIMV Circle

Tapnea
Trigger Window Out of Trigger Window
Psupp Pinsp Psupp

Trigger
Ti
（Pressure Trigger）
Flow
Exp%

Trigger
No Ventilation（Flow Trigger）
In Trigger Window

PSVPro is a pressure support ventilation mode with Apnea reserve ventilation.

In PSV Pro mode, when the patient's spontaneous respiration reaches the [Trigger] threshold, the
ventilator provides pressure support ventilation to the patient according to the preset [ΔPps], [Exp%],
and [Tslope]. During pressure support ventilation, the amount of inspiratory time and tidal volume are
determined by the patient's inspiratory strength and preset [ΔPps] levels, as well as the compliance and
resistance of the patient and the ventilator's entire system.
When the patient stops breathing or stops triggering for more than the preset time, the ventilator will
automatically switch to SIMV-PC/PS backup ventilation mode and ventilate according to the preset
[Trig Window], [Pinsp ], [Tslope] and [ΔPps], and provide alarm of Apnea ventilation;
When the ventilator is switched to backup ventilation mode, the Apnea ventilation alarm will continue
until the PSVPro restarts. When the number of continuous triggering ventilations of the patient reaches
the preset [Exit Backup] set value, the ventilator will restart PSVPro ventilation. When [Exit Backup]
is set to OFF, you must manually select PSVPro ventilation mode again to switch back to PSVPro
ventilation mode.
PSVPro mode settings:
 ΔPps
 Trigger
 Exp%
 Apnea ti
 Plimit
 PEEP
 Pinsp
 Tslope
 Tinsp
 Rate
 Trig Window

3-23
  Exit backup

3.8.2.4 Stop Mechanical Ventilation

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

3.9 Compliance of Circuit

Calculate the compressible volume in the patient‟s circuit:
1. Set the ventilator on the mechanical ventilation mode.
2. Set the VT to around 500 mL
3. Set the Rate to 10 bpm.
4. Set the I:E to 1:1.
5. Set the Plimit to 20 cm H2O.
6. Block the patient‟s port of the Y-piece. Pay attention to keep the port clean.
7. Start mechanical ventilation.
8. Monitor VTexp (Expired Tidal Volume) and Ppeak (Peak Pressure measured in the airway)
VTexp is intended to measure the needed gas volume in the patient‟s circuit.
The example below shows how to calculate the tubing compliance factor
VTexp／(Ppeak-2.5 1 cmH2O)= Compliance Factor; Unit: mL/cm H2O
Example: Ppeak=20 cm H2O, VTexp =24mL, 24/(20-2.5) =1.4 mL/cm H2O
The factor is used to calculate the gas compression volume in the patient‟s circuit. For example, if a
patient needs 30 cmH2O gas to conduct ventilation, then 42mL (calculated by 30 X 1.4= 42 mL)
gas shall be compressed in the tubing at each respiration. The 42 ml gas is part of the indicated tidal
volume, but it won‟t be delivered to the patient.
Note 1: Force applied in the bellows.

3.10 Fresh Gas Compensation

Range of fresh gas compensation: 10mL/min-10L/min;
Gas composition: oxygen, N2O, air, and anesthetic.

3.11 Timer
The timer is seated in the right bottom corner of the ventilator interface. It is helpful for an anesthetist 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

3-24
 below.

3.11.1 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] .

3.11.2 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] .

3.11.3 Reset Timer

1. Press the control knob or tap [Timer] → [Reset] to reset the timer.
2. The limit value turns to “00: 00: 00”, the [Reset] changes to [Start] .

3.12 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 5 breathing waveforms: pressure waveform, flow waveform,
volume waveform, EtCO2 waveform, and EEG waveform.
The system monitors breathing-related parameters: [Ppeak] , [Pplat] , [PEEP] , [VTexp] ,
[MV] , [Rate] , [FiO2] , [FiCO2] , [EtCO2] , [I：E] , [Pmean] , [VTinsp] , [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:

3-25
3.12.1 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 default interface of the system is the non-large font interface. Select [Config] → [Setting]
→ [Big Font] → [ON] / [OFF] to display the large font interface or the non-large font
interface .
The large font interface is shown as below.

3-26
3.12.2 Automatic waveform adjustment

At the end of six consecutive respiratory cycles, if the pressure, flow, capacity, and VT
measurements are greater than the boundary, the system will automatically adjust the waveform at
the beginning of the next respiratory cycle.
At the end of six consecutive respiratory cycles, if the pressure, flow, capacity, and VT
measurements are less than the boundary minus the amplitude, the system will automatically adjust
the waveform at the beginning of the next respiratory cycle.

3.12.3 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 unit. You can select
one unit by choosing [Config] → [Setting] → [Pressure Unit] .

3.12.4 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 volume.
The display of the flow waveform is optional. To enable/disable this display, you can select
[Config] → [Screen] → [Flow Wave] → [ON] / [OFF] .

3-27
 The display of the [VTinsp] is optional. To enable/disable this display, you can select [Config]
→ [Setting] → [VTi Display] → [ON] / [OFF] .

3.12.5 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 .

3.12.6 BIS Monitoring

When the BIS module communicates with the anesthesia machine normally,and the BIS display
waveform switch is turned on.Under the non-standby interface, you can monitor the real-time BIS
waveform.
The display of the BIS waveform is optional. To enable/disable this display, you can select [Config]
→ [Screen] → [BIS Wave] → [ON] / [OFF] .

3.12.7 Oxygen Concentration Monitoring

3.12.7.1 Turn on Oxygen Sensor Monitoring

1. Select [Config] → [Setting] →[O2 Sensor Monitor].

2. Set Oxygen Sensor to [On] / [OFF] under [O2 Sensor Monitor] menu as required.

Caution

3-28
  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 Monitor] 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 Monitor] 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.

3.13 Default settings

Select [Maintain] → [Config] → [Default config] to set default settings.

3.14 Spirometry Loop

The spirometry loop reflects mechanical ventilation conditions and patient‟s lung function, such as
patient‟s compliance, circuit leakage condition, airway blocking, etc., which plays an important
role in the clinical test. 2 loops and related respiratory mechanics parameters of the reference loop
are displayed in the interface, which is shown as below:
3-29
 A

E F

Fig. 3-12

A P-V(Pressure-Volume) Loop B Loop Parameters

C P-F(Pressure- Flow) Loop D Save Loop
E Switch of Reference Loop F Display Loop option
Three Spirometry Loop Available:
 Pressure–Volume (P-V)
 Volume- Flow (V-F)
 Pressure–Flow (P-F)

3.14.1 Select Loop

2 loops can be displayed in the system loop interface, including 3 types of combinations: [P-V]
loop and [P-F] loop; [P-V] loop and [V-F] loop; [V-F] loop and [P-F] loop. You can switch to
display among the 3 pairs of loops by selecting [Loops] → [Select Loop] . Take [P-V] loop and
[P-F] loop as example, as shown in the figure below:

3-30
 Fig. 3-13

3.14.2 Save Reference Loop

Select [Loops] → [Save Loop] to save the loop. The saved reference loop will be displayed in
another color, and the related respiratory mechanics parameters of the reference loop will be
displayed on the right of the loop area. Take [P-V] loop and [P-F] loop as example, as shown
in the figure below:

Fig. 3-14
3-31
3.15 Turn Off the System
Please follow the steps below to shut down when you do not intend to use the machine:
1. Ensure the machine can be ended.
2. Set the system switch to “ ”.
3. Turn off the AC power switch. Unplug the power cord to disconnect the power.
4. Remove the gas source hose to disconnect the gas source.

3-32
 Chapter4 Tests before Use

Warning
 Prior to using the equipment, make sure to read the User’s Manual and understand the
operation and maintenance of all components.

 If the equipment fails to pass the pre-use tests, do not use it, and contact the Company.

 As to anesthesia gas delivery system, monitoring devices, alarm system and protective devices
intended to serve an anesthesia systems, they are no matter singly used or assembled for an
anesthesia machine, a checklist of the anesthesia system shall be submitted.

Attention
 This guideline can be changed according to different situations of local clinical practice. Such
changes shall be subject to appropriate peer review.

 It is recommended that you check whether the N2O blocking function and the O2-N2O ratio
are normal before using the device. Use an O2 concentration tester to monitor the
concentration of O2 in the output gas.

4.1 Test Procedures

4.1.1 Test Interval

Pre-use tests shall be conducted in the following cases:

Before the anesthesia machine is used on the first patient every day

Before the anesthesia machine is used on each patient.

After anesthesia machine is repaired or maintained.

The recommended testing time and test items is given as follows:

Before the After anesthesia

Before anesthesia
anesthesia machine machine is repaired or
Test items machine is used
is used on the first maintained
on each patient
patient every day

4-1
Systematic inspection √ √
Alarm test √ √ √
Gas supply pipeline and gas cylinder
√ √
test
Flow control system test √ √
Anesthesia vaporizer installation test √ √
Anesthesia vaporizer back pressure
√ √
test
Breathing system leak test √ √ √
Oxygen flush test √ √ √
AGSS transfer and receiving system
√ √
test
Vacuum suction device test √ √

4.1.2 Before the Anesthesia Machine Used on the First Patient Every

Day

1. Verify that the required emergency equipment is kept ready and in good condition.
2. Conduct test and verify that the equipment is kept in good order and condition, and the
components are connected correctly.
3. Verify the connection of gas supply system, and verify that the gas cylinders are already
assembled, and the displayed pressure values are correct.
4. Verify the liquid anesthetic level inside the anesthesia vaporizer is appropriate, and check
that the anesthesia vaporizer fits its mounting perfectly.
5. Verify that the respiration circuit is connected correctly and intact.
6. Verify that there is enough renewed CO2 absorbent inside the CO2 canister.
7. Connect the scavenging system, and verify that the system works well.
8. Turn the system switch to “ON”, the system automatically performs a series of self-tests.
Verify that the system passes all the self-tests.
9. If the system passes the self-tests, perform “Automatic circuit leak testing” and “Manual
circuit leak testing”.
10. Make sure that the oxygen supply is adequate.
11. Select correct patient types like [Adult] or [Child].
12. Start ventilation.
13. Set proper controlling values and alarm limits for the patient.

4-2
4.1.3 Before Anesthesia Machine Used on Each Patient

If you have finished tests as described in section 4.1.2 Before the Anesthesia machine Used on
the First Patient Every Day, it is unnecessary to conduct this test, that is the test before the
machine is used on each patient, for the first patient..
1. Verify that the required emergency equipment is kept ready and in good condition.
2. Verify that the level of liquid anesthetic inside the anesthesia vaporizer is appropriate.
3. Verify that the respiration circuit is connected correctly and intact.
4. Verify that the breathing system is filled with enough absorbent.
5. Connect the vacuum suction device and verify that the system is working properly.
6. Conduct gas leak testing of the breathing system.
7. Adjust the APL valve (set it to 30cmH2O).
8. Start ventilation.
9. Set proper controlling values and alarm limits for the patient.

4.1.4 After Anesthesia Machine is Repaired or Maintained

Please refer to 4.1.2 Before the Anesthesia Machine Used on the First Patient Every Day.

4.2 Check the System

Warning

 Make sure that the breathing system is connected properly and intact.

 When installing the absorption canister, check whether the seal ring is installed correctly. If
the seal ring is not properly installed, leakage of the breathing system may occur.

 The maximum bearing weight of the top support is 20kg.

 The maximum bearing weight of the workbench is 20kg.

Check the system and make sure that the following requirements are satisfied:

1. Equipment is kept in good condition

2. All components are connected correctly.
3. Check the flowmeter, anesthetic vaporizer, barometer, and gas supply pipes for damage.
4. Breathing system is connected properly, and the respiratory pipelines are intact. Equip with
sufficient CO2 Pre-Pak absorbent or CO2 bulk absorbent. Manual ventilation device is

4-3
 available and functional.
5. Anesthesia vaporizer is locked up correctly and is filled with adequate anesthetics.
6. Gas supply system is connected correctly, and its pressure is kept normal.
7. If equipped with a spare cylinder, make sure that it is installed correctly, and close the
connected cylinder valve.
8. Check whether auxiliary oxygen supply is available and functioning properly.
9. Required emergency equipment is kept ready and in good condition.
10. All equipment for airway maintenance and tracheal intubation are kept ready and in good
condition.
11. Applicable anesthetic agents and emergency drugs are kept ready.
12. Check the color of soda lime in the absorber. If the color changes significantly, replace soda
lime immediately.
13. Make sure that the castor brake or central brake is locked up without damage or looseness
to prevent the anesthesia machine from moving.
14. Make sure that the breathing system of anesthesia machine is fixed onto the adapter, and
verify that the breathing system is already locked up.
15. Connect the power cord to the AC power supply. When AC power supply is connected, the
AC power indicator and battery indicator are on. If the indicators are off, the system is not
powered.
16. Make sure the anesthesia machine can be turned on and turned off.

4.2.1 Gas Supply Pipeline Test

4.2.1.1 Gas Supply Pipeline

Caution

 During the pipeline ventilation, do not set the backup cylinder valve to “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 Test

1. If anesthesia machine is equipped with a backup cylinder, turn off the backup cylinder
valve. Connect the pipeline of O2 supply.
2. Set the system switch to the position “ON” ( ).
3. Rotate the flow control knob to the medium level of measuring range.
4. Make sure that the pressure value indicated by O2 Pipeline pressure gauges is in the range
4-4
 of 280 to 600kPa.
5. Cut off O2 pipeline supply.
6. As O2 pressure drops, alarms[No O2 Pressure].
7. Make sure that O2 pressure gauge returns to its zero position.
8. Disconnect the pipeline of O2 supply.

4.2.1.3 N2O Pipeline Test

To conduct N2O pipeline test, turn on O2 first. For specific operational procedures of N2O
supply pipeline test, refer to 4.2.1.2 O2 Pipeline Test.

Caution

 To conduct N2O gas supply pipeline test, turn on O2 first, and make sure that the O2 gas
supply pressure ranges from 280 to 600kPa; Otherwise, N2O flow cannot be regulated.

 When N2O supply is cut off, the system will not give alarms related to the N2O pressure as
N2O pressure drops.

4.2.1.4 Air Pipeline Test

For specific operational procedures of air pipeline test, please refer to 4.2.1.2 O2 Pipeline Test.

Caution

 When air supply is cut off, the system will not give alarms related to the air pressure as air
pressure drops.

4.2.2 Backup Gas Cylinder Test

If anesthesia machine is not equipped with a backup cylinder, it is unnecessary to conduct the
test.

4.2.2.1 Check the Fullness of the Cylinder

1. Set the system switch to the position “OFF” ( ), and connect the gas cylinder to be
checked.
2. Turn on the valves of all backup cylinders.
3. Make sure that the pressure inside all gas cylinders is adequately high. If not, turn off
corresponding gas cylinder valve, and replace the cylinder with a fully-filled one.
4. Turn off the valves of all backup cylinders.

4-5
4.2.2.2 High-pressure Gas Leak Test of O2 Cylinder
1. Turn on the valves of all backup cylinders.
2. Set the system switch to the position “OFF” ( ) and stop O2 pipeline gas supply.
3. Rotate O2 flow control knob, and turn off the O2 flowmeter.
4. Turn on the valve of O2 gas cylinder.
5. Read and record the values displayed in backup cylinder pressure gauge.
6. Turn off the valves of O2 cylinders.
7. In a minute, read and record the values indicated in the backup cylinder pressure gauges.

If the values indicated by the backup cylinder pressure gauges decrease greater than 5000kPa
(725psi), it means that gas leak exists, Replace with a new gas cylinder washer as described in 5.6
Assemble the Anesthesia Vaporizer. Repeat the steps 1~ 6 in section 4.2.2.2 High-pressure Gas
Leak Test of O2 Cylinder. If gas leak still exists, do not use the cylinder.

4.2.2.3 High-pressure Gas Leak Test of N2O Cylinders

Please conduct high-pressure gas leak test of N2O cylinders as per the steps described

in4.2.2.2 high-pressure gas leak testing of O2 gas cylinders. If the value indicated in the N2O

high-pressure pressure gauge decreases greater than 700kPa (100psi) in 1 minute, it indicates

that gas leak exists.

4.2.2.4 High-pressure Gas Leak Test of Air Cylinders

Please conduct high-pressure gas leak testing of air gas cylinders as per the steps described

in4.2.2.2 high-pressure gas leak testing of O2 gas cylinders. If the value indicated in the air

high-pressure pressure gauge decreases greater than 700kPa (100psi) in 1 minute, it indicates

that gas leak exists.

4.2.3 O2 and N2O linkage test without O2 sensor

Warning

 Even if fresh gas contains enough oxygen, it may mix the low oxygen gas in breathing
system.

 If N2O exists and flows through the system during the testing, the N2O gas shall be collected
and eliminated as per safe and acceptable methods.

 Improper mixed gas may injure the patients. If the oxygen-N2O linked system cannot

4-6
 provide well-proportioned O2 and N2O, the system shall not be used.

Caution

 To avoid damage, turn on the gas cylinder valve slowly.

 When backup gas cylinder testing is over, turn off all the gas cylinder valves if the backup
cylinders are not intended for gas supply.

 Turn the gas flow switches slowly, and do not turn them forcibly when the maximum or
minimum flow range is exceeded to protect the control valve from damage and to avoid
control failure. When flowmeter is adjusted to the minimum value, the reading shall be zero.

Conduct the flow control system testing as per the following steps when O2 sensor is not
equipped with:

1. Connect pipeline or turn on gas cylinder valve slowly.

2. Rotate clockwise all flow control knobs of flowmeter to the end (minimum flow).
3. Set the system switch to the position “ON” ( ).
4. If battery charge is low 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 O2-N2O linked system;
Rotate clockwise O2 and N2O flow control knobs respectively to adjust the flow of O2 and
N2O to the minimum. Then rotate counterclockwise N2O flow control knob, adjust N2O flow 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 decrease of O2-N2O linked system;

Rotate clockwise O2 and N2O flow control knobs to adjust the flow of O2 and N2O to over
9.0L/min and 3L/min respectively. Then rotate counterclockwise N2O flow control knob, and
adjust N2O flows 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.

4-7
 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

8. Cut off oxygen pipeline supply or turn off oxygen gas cylinder.

Caution

 When O2 supply is cut off, alarms “No O2 Pressure” is given as O2 pressure drops.

9. Set the system switch to the position “OFF” ( ).

4.2.4 O2 and N2O linkage test with O2 sensor

Before start this section test, test the oxygen monitoring device as described in “Alarm
Testing”. Then conduct the flow control system testing as per the following steps when O2
sensor is equipped with:

1. Connect pipeline supply or turn on gas cylinder valve slowly.

2. Rotate clockwise all flow control knobs of flowmeter to the end (minimum flow).
3. Set the system switch to the position “ON” ( ).
4. If battery charge is low 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 increase of O2-N2O linked system;

Rotate clockwise O2 and N2O flow control knobs respectively to the end (minimum flow).

Rotate counterclockwise the N2O flow control knob slowly.

Make sure that the O2 flow is increasing, and the measured O2 concentration must be equal to or
greater than 25% in the whole process.
4-8
 7. Test the flow reduction of O2-N2O gas linked system:

Rotate N2O flow control knob,to 9.0L/min.

Rotate O2 flow control knob to 3L/min or higher.

Rotate clockwise the O2 flow control knob slowly.

Make sure that the N2O flow is increasing, and the measured O2 concentration must be equal to or
greater than 25% in the whole process.

8. Cut off the O2 pipeline supply or turn off the O2 cylinder valve.
9. Make sure:

Stop N2O flow, and O2 flow is cut off finally.

If an air supply is connected, air flow shall be maintained.

Ventilator may give alarm related to inadequate gas supply.

10. Rotate clockwise all flow control knobs to the end (minimum flow).
11. Connect the O2 pipeline supply or turn on the O2 gas cylinder valve again.
12. Set the system to standby mode.

4.3 Anesthesia Vaporizer Back Pressure Test

Warning
 During testing, the anesthetic shall come from the fresh gas outlet. These agents shall be
discharged and collected as per safe and acceptable methods.

 To avoid any damage, rotate clockwise the flow control knob to the end (minimum flow or
turn it off) prior to use.

1. Set the system switch to the position “ON”. An alarm might be given.
2. Set the O2 flow to 6L/min.
3. Make sure that the O2 flow is constant, and that the float of oxygen flowmeter (for
AX-600) or main flowmeter (for AX-700, AX-700A, AX-800) can move freely.
4. Adjust the concentration of anesthesia vaporizer between 0 ~ 1%. The O2 flow must not
decrease greater than 1L/min in the whole process. If O2 flow decreases greater than
1L/min:
 Replace the anesthesia vaporizer with a new one;

 If O2 flow decreases less than 1L/min after the replacement, the old anesthesia

4-9
 vaporizer is faulty.

 If O2 flow decreases 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.

4.4 Alarm Tests

Anesthesia machine automatically performs self-test once it is turned on. The alarm lamp
flashes once as per red- orange sequence, and a beep is given. Then startup screen is displayed.
When[Check before use], [Leak in vent mode] and [Leak in bag mode] are finished, the
equipment accesses its standby screen directly. This indicates that the audible and visual alarm
indicator works normally.

Caution

 During alarm testing, stay in a place where you can observe the alarm lamps and alarm
prompts and hear the alarm sound.

4.4.1 Monitoring the O2 Concentration and Testing 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 equipment conforming to corresponding
international standards to monitor the oxygen concentration.

Caution

 It is unnecessary to conduct the testing if O2 sensor is not equipped.

1. Set the Manual/mechanical ventilation switch to the position [Manual] ( ).

2. Take the O2 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 at 21%.
3. Set the [Low Limit] of [FiO2]: On the screen, 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 message area on the screen, make sure that [Low FiO2] is displayed.
4-10
 5. Set the [Low Limit] of [FiO2] to a value lower than the current monitored value of [FiO2] ,
and make that the alarm of [Low FiO2] is cleared.
6. Re-install the O2 sensor into the breathing system.
7. Set the [High Limit] of O2 alarm: Select [Alarm] menu → Access [ventilator] → Select
[FiO2] [High Limit] menu, and set the high alarm limit of the parameter to 50%.
8. Connect the manual respiration manual bag to corresponding connector of breathing system.
Push the oxygen flush button to fill the manual/spontaneous bag, and make sure that the O2
concentration [FiO2] measured by sensor is of approximately 100%.
9. Observe the physiological alarm message on the screen, and make sure that [High FiO2] is
displayed.
10. Set the [HighLimit] of [FiO2] alarm to 100%, and make sure that [High FiO2] is cleared.

4.4.2 Test the Minute Volume (MV) Alarm

1. Make sure [Per-minute ventilation Amount] alarm is set to “ON”.

2. Set the [Low Limit] alarm of [MV] : On the screen, 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 message area on the
screen, and make sure that [Low MV] is displayed.

4. Set the [High Limit] alarm of [MV] : On the screen, 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 message area on the
screen, and make sure that [High MV] is displayed.

4.4.3 Test the Apnea Alarm

1. Connect the manual respiration manual bag to the corresponding connector of the breathing
system.

2. Set the Manual/Mechanical Control switch to [Manual]( ).

3. Rotate the APL valve control knob to the position with the minimum opening pressure.
4. Pinch the manual respiratory manual bag, and make sure that one complete respiratory
cycle takes place.
5. Stop pinching the manual respiratory manual bag, and wait for at least 20± 3 seconds. Make
sure that [Apnea] alarm is displayed on the screen.
6. Pinch the manual respiratory manual bag for several times, and make sure that the [Apnea]
alarm displayed on the screen disappears.
4-11
4.4.4 Test the Sustained Airway Pressure Alarm

1. Connect the manual respiratory manual bag to the corresponding connector of the breathing
system.
2. Rotate the O2 flow control knob to the low limit.
3. Rotate the APL valve control knob to the position of 30cmH2O.

4. Set the Manual / Mechanical Control switch to its position [Manual] ( )

5. Push and hold the oxygen flush button for approximately 15 seconds, and make sure that
[Continuous Pressure] alarm is displayed on the screen.
6. Turn on the patient-end outlet, and make sure that [Continuous Pressure] alarm displayed
in the screen disappears.

4.4.5 Test the High Paw Alarm

1. Set the Manual/mechanical Control switch to its position [mechanical] ( ).

2. On the screen, 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. Make sure that [High Paw] is displayed in the screen.
4. Set the [High Limit] of airway peak pressure to 40cmH2O.
5. Make sure that [High Paw] displayed in the screen disappears.

4.4.6 Test the Low Paw Alarm

1. Set the Manual / Mechanical Control switch to its position [mechanical] ( ).

2. On the screen, 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 Y-shaped patient-end port.
4. Wait for 20 seconds, observe the alarm message area on the screen, and make sure that
[Low Paw] alarm is displayed in the screen.
5. Connect the manual respiration manual bag to manual respiration leather-bag port on the
breathing system.
6. Guarantee that [Low Paw] displayed in the screen disappears.

4.4.7 Test the CO2 Monitor Alarm

1. Refer to “Chapter 7 Physiological 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]
4-12
 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.

4.5 Breathing System Testing

Warning
 Foreign objects inside the breathing system may block up the gas flow 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.

 The resistance at 2,5, 15 and 30 l/min, and compliance of those breathing accessories,please
refer to the instructions for details.

 The range of internal volume of any Anesthetic breathing system less than 3.5L.

 Breathing system shall be equipped with a ventilator conforming to ISO 80601-2-13.

1. Make sure that the breathing system is connected properly and is kept in good condition.
Once the breathing system is disconnected, the anesthesia machine can give an alarm
[No Breathing System].
2. Make sure that the check valves in the breathing system work fine.

If the inspiratory check valve turns on during inspiration, and immediately turns off when
expiration begins, it indicates that the inspiratory check valve (unidirectional valve) works fine.

If the expiratory check valve turns on during expiration, and immediately turns off when
inspiration begins, it indicates that the expiratory check valve (unidirectional valve) works fine.

4.5.1 Bellows Tightness Test

1. Set the system to its standby mode.
2. Set the Manual/mechanical ventilation switch to its position [Mechanical]( ).

4-13
 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 oxygen flush 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 airway pressure gauge may not exceed
15cmH2O.
7. The folded sack of bellows shall not drop. If yes, gas leak exists in the bellows. Reassemble
the bellows.

4.5.2 Breathing System Leak Test in Mechanical Ventilation Mode

Caution

 System leak test includes the leak test of anesthesia breathing system and anesthesia
ventilator.

 System gas leak test must be conducted in its standby mode.

 To conduct system gas leak test, make sure that the breathing system is connected correctly,
and the respiratory pipelines are kept in good condition.

Conduct gas leak testas 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] screen.
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. Rotate the flow control knob to turn off the O2, N2O and air flow completely.
6. Push the oxygen flush button to have the folded sack of bellows risen 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 test and displays
simultaneously the prompting message: [Testing is Performing].
9. If the system passes the test, it displays a prompting message: [Leak Test PASS].
Otherwise, it displays a prompting message: [Leak Test FAIL ]. In such a case, check the
breathing system connection and pipelines tightness. Conduct leak test again when
problems are solved.

4-14
 Caution

 The progressive gas leak testing can be terminated if you push [Stop] button. That does not
mean the system gas leak testing fails, only means that the testing gets invalid.

 If gas leak testing fails, check all possible causes of gas leak, such as leakage from bellows,
breathing system pipeline, CO2 canister and other connecting devices. During the check of
CO2 canister, pay attention to the seal components of canister to find if any CO2 absorbent
particles are attached on the canister, and remove them if any.

 If leaks exist in the breathing system, do not use the equipment. Contact in time the
equipment service personnel or after-service department of the Company.

 Loose connection between the bellows and the intubation tube will result in leakage of the
breathing circuit, and will affect the VT supply anomaly of the anesthesia machine.

4.5.3 Breathing System Leak Test in Manual Ventilation Mode

1. Guarantee that the system is already set to the standby mode; Otherwise, push the standby
key ( ) to access [Standby] screen.

2. Set the Manual/mechanical ventilation switch to the position [Manual]( ).

3. Connect the manual respiration manual bag to corresponding connector on the breathing
system.

4. Rotate the APL valve control knob to the position of its maximum value (75cmH2O).

5. Rotate 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/spontaneous
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 airway gauge 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 test and displays
simultaneously the prompting message: [Testing is Performing].

10. If the equipment passes the test, the system displays a prompting message [Leak Test
PASS] .Otherwise, it displays a prompting message: [Leak Test FAIL ]. In such a case,
check the connection of breathing system and condition of pipelines. 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 airway pressure

4-15
 gauge during testing. If the readings drop, it indicates that gas leak exists.

4.5.4 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] screen.

2. Set the Bag/vent Control switch to the position [Manual] ( ).

3. Connect the manual respiration manual bag to the corresponding connector on the
respiratory circuit.

4. Insert the Y-piece of corrugated pipe into the leak testing plug of Manual/spontaneous bag
port to block up the gas outlet of Y-piece.

5. Rotate the APL valve control knob to 30cmH2O.

6. Push the oxygen flush button to fully fill the manual/spontaneous bag.

7. Make sure that the readings indicated by airway gauge are in the range from 20 to
40cmH2O.

8. Rotate the APL valve control knob to the position of the minimum value for the opening
pressure of APL valve (position MIN).

9. Set the O2 flow to 3L/min, and turn off other gases.

10. Make sure that the reading indicated by the airway pressure gauge is less than 5cmH2O.

11. Push the oxygen flush button, and make sure that the reading indicated by airway gauge
does not exceed 10cmH2O.

12. Rotate the O2 flow control knob to the minimum value, and verify that the reading indicated
by the airway gauge does not drop to below 0cmH2O.

4.5.5 Check Valve Inspection and Test

1. Check whether or not valves evenly stay inside the base when the system is turned off.

2. Turn on the system.

3. Make sure that the gas supply pressure is adequate.

4. Set the Manual/mechanical ventilation switch to the position [Mechanical ] ( ).

5. Start ventilation.

6. Make sure that ACGO is already set to its non-ACGO mode

7. Check whether or not the respiration check valve moves in the open-close cycle. If not, the
check valve is faulty.

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4.6 Ventilator Test

Caution

 Ventilator shall be equipped with an anesthesia system conforming to IEC 80601-2-13.

1. Make sure that the gas supply pressure is adequate.

2. Make sure that the relevant parameters and alarm limits of ventilator are properly set. For
specific settings, refer to the chapter “15.11 Principle and Parameter Specifications of the
Ventilator”.

3. Set the Bag/vent Control switch to the position [Mechanical].

4. Connect the manual manual 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 can meet the clinical requirements.

4.7 AGSS Transfer and Receiving System Test

Assemble the AGSS properly as per 5.10.2 Assemble the AGSS, and start AGSS. Check
whether or not the floater rises up and exceeds the scale mark MIN. If the floater sticks during
movement or the floater is damaged, contact the manufacturer for maintenance.

Caution

 Do not block the pressure compensation port of AGSS during the test.

If the floater cannot rises up, possible causes include the following:

1. Floater adhesion. Turn the AGSS upside down, and check whether or not the floater may
move up and down freely.

2. Floater rises slowly. Filtering net is possibly blocked Contact the manufacturer for checks
and maintenance.

3. The high-flow AGSS transfer and receiving system is not working or the pumping flow rate
is less than 50L / min (normal working rate). Contact the manufacturer for inspection and
repair.

4. The low-flow AGSS transfer and receiving system is not working or the pumping flow rate
is less than 25L / min (normal working rate) . Contact the manufacturer for inspection and

4-17
 repair.

4.7.1 Connection Leakage Test for AGSS and the Exhaust Gas Outlet

of Anesthesia Machine

1. Remove the rear cover of the host, and remove internal corrugated tube that is connectod to the
air-capacitor.
2. Connect the tubing sets to be tested onto the inlet of air-capacitor. Connect the pressure gauge.
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 transfer and receiving system.
5. If the leakage amount exceeds the above value, re-connect the tubing sets of the exhaust gas
outlet, and then retest according to the above steps.

4.8 Vacuum Suction System Test

4.8.1 External Vacuum Suction System Test

Note

 Please refer to the user manual supplied with the external vacuum suction system for
testing information on the external vacuum suction system.

 The vacuum suction system must be inspected before use, accordint to the requirement
specified in the user manual supplied with the vacuum suction system.

1. Assemble external negative pressure to the anesthesia machine according to the installation
instructions;
2. Press the driving gas switch to the OFF position; turn the negative-pressure gear switch to the OFF
position as well;
3. Rotate the negative-pressure adjustment knob counterclockwise until it can no longer be rotated;
4. Open the O2 source, and confirm whether the gas source pressure is within the applicable range of
the external negative-pressure system (280-550kPa);
5. Pull the driving gas switch to the ON position;

4-18
6. Block the patient end of the suction tube, and turn the negative-pressure gear switch to the FULL
position; observe whether the reading on the negative pressure gauge can reach 60kPa or above;
7. If there is no reading on the negative pressure gauge, check whether the collecting liquid bottle,
suction tube, overflow bottle, and filter are not installed well, or check for damage and gas leakage;
8. After confirming that the gas circuit connection is intact, turn the negative-pressure gear switch to
the OFF position, and observe whether the pressure on the negative pressure gauge has returned to
zero;
9. Turn the negative-pressure gear switch to the REG position; slowly rotate the negative-pressure
knob clockwise; observe the pressure gauge; confirm whether the pressure can be continuously
adjusted and stabilized at a certain pressure;
10. After completing the inspection, turn the negative-pressure adjustment knob counterclockwise to
adjust the negative pressure to the minimum;
11. Turn the negative-pressure gear switch to the OFF position, and press the negative-pressure driving
gas switch to the OFF position, so as to avoid gas waste.

4-19
 Chapter5 Installation and Connection

Warning
 If electrosurgical equipment is used, keep their leads away from the breathing system,
oxygen sensor and other components of the anesthesia machine, make sure that the standby
manual/spontaneous equipment of anesthesia machine are ready for use, and ensure that
masked simple respirator are available in case the electrosurgical equipment prevents safe
use of the ventilator. In addition, ensure that all life supporting and monitoring equipment
may be correctly operated.

 If high frequency surgical equipment is used, antistatic or conductive masks or breathing

tubes may cause heat injuries; therefore, never use antistatic or conductive masks or
breathing tubes.

 The equipment shall be installed by engineers specified by the manufacturer.

 The equipment is provided with a waste gas exhaust port. The users shall pay attention to
the disposal of residual breathing gase scavenged.

 After the absorbent gets dry, it may pose a danger to the patient if it continues to be used.
Appropriate precautions shall be taken to ensure that the soda lime in the CO2 absorption
canister is not dry. After each use of the system, all gas sources shall be turned off in time.
 The anesthesia system has an exhaust outlet. During use, pay attention to the disposal of
discharged respiratory residual gas.

5.1 Assemble the Breathing System

Caution

 After the use of the equipment, pay attention to the disposal of the breathing system, the
test of the CO2 absorbent inside Canister (carbon dioxide absorbent) and anesthetics 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.

5-1
  If the difference between airway pressure gauge reading and the parameter value displayed
on the screen is large, contact the Company.

 Breathing System Structure

11
10 12

9 13
8 14
7

6 15

4
3

2 1

17 18 19 20 21
16

1 Expiratory port 12 Manual bag Support Arm

2 Canister (carbon dioxide absorbent) 13 Manual / Mechanical Control switch

5-2
 3 Canister release device 14 Inspiratory check valve
4 Manual drain valve 15 Inspiratory port
5 Leak test plug 16 Circuit Lock Hook
6 Breathing tube hook 17 Pressure Sampling Port
7 Expiratory check valve 18 Waste Gas Outlet
8 APL (Adjustable Pressure Limiting) Valve 19 Fresh Gas Inlet
9 Airway pressure gauge 20 Driving Gas Inlet
10 Manual bag port 21 Guide Post Hole

11 Bellows assembly

 Circuit Adapter Structure

7 6

1 2 3 4 5

1 Circuit Support Guide Post 5 Pressure Sampling Connector

2 Drive Gas Connector 6 Circuit Disassembling Button
3 Fresh Gas Connector 7 Manual/Mechanical Control Axle
4 Waste Gas Exhaust Connector 8 Heater Sheet

5.1.1 Assemble the Breathing Circuit System

1. Align the guide post hole on the side of breathing circuit system with the

guide post of circuit adapter.

5-3
 1

2. Push the breathing circuit system into the circuit adapter forcibly such
that the breathing circuit system is connected to the circuit adapter
without gap. Verify that the breathing circuit system has been locked.

Warning

 When breathing circuit system is assembled onto the circuit adapter, you must verify that
the breathing circuit system is firmly locked. If not, it may be separated from the circuit
adapter during operation, resulting in severe leak of fresh gas and mismeasurement of tidal
volumes.

Caution

 If it is very hard to push the breathing circuit system in, check whether or not the nuts on
the downside of the breathing circuit 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 circuit system, it is necessary to apply
small quantity of lubricating oil (du pont Krytox high-performance fluorine grease) onto the
seal rings of air ports of the circuit adapter.

5-4
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.

2 Assemble the manual support column connector to the breathing

system connector, as shown in the right figure.

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

5-5
5.1.3 Assemble the Manual Bag

1. Fit on the manual bag upward, and screw it onto the manual support column.

5.1.4 Assemble the Bellows Components

1 Attach the bottom bottom ring of folded sack onto the bellows base of the breathing system, as
shown in the figure below: Ensure that the folded sack is tightly connected to the bellows base,
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.

1. Folded Sack
2. Bellows base
3. Seal Component

1 ①

2 ②

3 ③

2 Align the bayonet of bellows cover with the slots on 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. as shown in the right figure:

5-6
 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-off or warpage is found, assemble the seal components
properly before bellows cover is assembled.

5.1.5 Assemble the Flow Sensor

1 Ensure that the direction of arrow marked on the flow sensor is same to that on the breathing
system, and the side with arrows is facing upward, as shown in the figure below:

2 Align the flow sensor to the slot and insert it horizontally.

5-7
 3 The breathing joint slot is aligned with the upper and lower slot of the flow sensor,as
show in the figure.

4 Align the breathing joint and the lock nut to the flow sensor interface and tighten the
lock nut clockwise.

Warning

 Tighten the breathing connector locking nut when installing the flow sensor, otherwise flow
sensor measurement may be invalid.

5.1.6 Assemble the Breathing Tube , Y-piece and mask

Caution

 To assemble the Breathing Tube, hold the connectors at both ends of the Breathing Tube so
as not damage the Breathing Tube.

1 Connect mask, filter to the Y-piece.

2 Assemble the expiratory tube and inspiratory tube onto the expiratory port and inspiratory port
on the breathing system respectively.
5-8
 2
5.1.7 Assemble the Oxygen Sensor

Warning
 Before assembling the oxygen sensor, check if the seal rings of oxygen sensor is in good
condition. Replace the oxygen sensor with a new one if no seal rings is installed or the seal is
damaged.

 The O2 sensor unpacking combination must be correct,screwed in place and not skew.

 Oxygen sensor must be assembled properly; otherwise gas leakage may occur in the
breathing system.

1. Align the oxygen sensor with 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 main machine, as shown in the right figure:

5-9
5.1.8 Assemble the Airway Pressure Gauge

1 Before assembling the airway pressure gauge, 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 airway pressure gauge into the buckle of CPC
connector. The airway pressure gauge is securely assembled if a
sound “De” is heard.

5.2 Install the CO2 Absorbent Canister

Warning
Please observe the following applied provisions for safety protection:

 Do not use the CO2 absorbent canister with chloroform or trichloroethylene.

 Change absorbent frequently to prevent sedimentation of non-metabolic gas when the

system is not in use.

5-10
 Use of desiccated 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 when
finished using the system.

 Disposable Canister (carbon dioxide absorbent) is a 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
absorbent canister. 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 ventilation might cause leakage in the breathing system.

 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.

 CO2 concentration monitoring is strongly recommend. The equipment may be

connected to a CO2 analyzer conforming to ISO80601-2-55 for monitoring the CO2
output concentration. The CO2 analyzer to be used is not limited to PHASEIN brand.
For details of the operation guide and precautions, see the attached specification sheets
for attachments.

 Before assembling 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 or 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
canister may not get dry. All gas supplies shall be turned off in time when finished using
the system. If thoroughly dry CO2 absorbent is exposed to anesthetics, it may release
carbon monoxide (CO), and its continuing in service may do harm to the patients.
Replace CO2 absorbent in time for the safety of patients.

 Please clean CO2 absorbent and replace the sponge of Canister (carbon dioxide

5-11
 absorbent) regularly; Otherwise CO2 absorbent powder settled inside the Canister
(carbon dioxide absorbent) may go into the breathing system.

 Please clean the Canister (carbon dioxide absorbent) rim regularly. Otherwise the CO2
absorbent particles sticking on the rim may result in leakage in the breathing system.

 To assemble the CO2 absorbent, check Canister (carbon dioxide absorbent) rim,
strutting piece and seal for attached CO2 absorbent particles. If any, remove the
particles; otherwise they might result in leakage in the breathing system.

Caution

 Gradual color change of absorbent inside the canister indicates that absorption of carbon
dioxide. The color change of absorbent is only a rough indication. It is advisable to determine
when to replace the absorbent by carbon dioxide concentration monitoring.

 Discolored absorbent shall be discarded. If left standing for several hours, it may regain its
original color giving a misleading indication.

 Prior to operating the product, read the operating instruction completely.

 The breathing system of anesthesia machine includes the self closed- circuit system and
non-closed- circuit system. The difference between them is that the former is equipped with
the Bypass function.

1 Check whether the support and rim of the CO2 absorbent

canister,are attached with absorbent particles or powder. If any,
please remove them. The filled CO2 absorbent cannot be higher
than the “-MAX-” mark on the CO2 absorbent canister.

2 Pinch the CO2 absorbent canister lock catch with the left hand

and rotate it rightward to unlock the canister bracket ,as

shown in the right figure.

2
5-12
3 Align the CO2 absorbent canister with the mounting slot of the
canister bracket, as shown in the right figure.

4 Push the CO2 absorbent canister to the end of the mounting slot
of the canister bracket until it is fixed, as shown in the right
figure:

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

the right figure:

5-13
 6 The CO2 absorbent canister 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 absorbent canister. But be
sure to timely replace the CO2 absorbent and install the CO2 canister to prevent CO2 retention.
1. Push the release device of CO2 absorbent canister to remove the CO2 absorbent canister, as shown
in the figure below.

2. The filled CO2 absorbent cannot be higher than the “-max-” mark on the CO2 absorbent canister.
Check whether the CO2 canister strutting piece, seal ring and the rim are attached with CO2
absorbent particles or powder. If any, please remove them. Push the CO2 absorbene canister to the

end of the mounting slot until it is fixed , as shown in the right figure:

5-14
 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 color change of absorbent inside the canister indicates that absorption of carbon
dioxide. The color change of absorbent is only a rough indication. It is advisable to determine
when to replace the absorbent by carbon dioxide concentration monitoring.

 Discolored absorbent shall be discarded as per local correlative laws and Regulations or
waste disposal system of the hospital. If left standing for several hours, it may regain its
original color giving a misleading indication. 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 used.

 “Medisorb TM” CO2 absorbent is recommended.

1. Disassemble the CO2 absorbent canister, referring to the reverse process of CO2 absorbent canister
assembling in the section 5.2 of this chapter.
2. Pinch the lock catch of the CO2 absorbent canister with your left hand and rotate it rightward, as

shown in the flag, open the canister bracket and take it out with your right hand .
3. Take out the discolored CO2 absorbent.
4. Fill the new CO2 absorbent into the CO2 absorbent canister along the inside periphery to prevent
absorbent entering the ventilation hole of the strutting piece, otherwise, it may increase airway
resistance.
5. Check whether the CO2 canister strutting piece, seal ring and the rim are attached with CO2
absorbent particles or powder. If any, please remove it. The placed CO2 absorbent cannot be more
than the “-MAX-” mark on the CO2 absorbent canister.

5-15
 6. Please refer to the procedure in the section 5.2 of this chapter to reassemble the CO2 absorbent
canister.

Warning

 To remount Canister (carbon dioxide absorbent) after replacement of the absorbent

(carbon dioxide absorbent), be sure to check Canister (carbon dioxide absorbent) for locking
so as to ensure proper assembling.

Caution

 The CO2 absorbent must not exceed the “-MAX-” level marked on the Canister (carbon
dioxide absorbent)

5.5 Connection of Gas Supplies

The anesthesia machine is provided with 2 types of gas supplies: pipeline gas supplies (O2,
N2O and AIR) and gas cylinder (O2 ,N2O, AIR).

One type of configuration is provided for pipeline gas supplies:

 O2, N2O and AIR

Three types of configuration are provided for cylinder gas supplies:

 O2

 O2 and N2O

 O2 and AIR

Warning
 Only medical-use gas supplies are allowed to used. Other types of gas supplies might
contain water, oil or other contaminants.

 If the central gas supply system develops a fault, one or more equipments connected to it
may quit work. In such a case, 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.

5-16
5.5.1 Pipeline Inlets
The anesthesia machine provides 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 the gas supply hose and connector with the gas supply inlet on the back of anesthesia
machine and insert it.

3. Ensure that the gas supply hoses are securely connected to the gas supply inlets, and tighten the
hose nuts by hand.

Caution

 The gas supply hoses shall meet the standards of ISO 5359.

 The hose connectors shall meet the standards of ISO 9170-1.

5.5.2 Waste Gas Exhaust

There are two exhaust components, located on the left and the rear of the workbench, respectively.
There are two exhaust ports, which are the exhaust port of the AGSS and PEEP generating device.
For waste gas exhaust, the following shall be adopted:

1. PEEP exhaust port and internal vacuum suction vent, which may directly discharge
oxygengases indoors.
2. Outside diameter of AGSS connector is 30mm, with a taper of 1:20. Please connect Anesthetic
gas scavenging system or passive waste gas treatment system.

Warning
 The PEEP exhaust port may continuously discharge small quantity of oxygen. Never block
the outlet; otherwise the anesthesia ventilator cannot work.

 Prior to an operation, anesthesia machine shall be equipped with an anesthesia gas

scavenging system conforming to ISO 80601-2-13 and YY 0635.2 to purify the air inside the
operating room.

 If your anesthesia machine is not equipped with active AGSS, please do not connect the
waste gas exhaust port of anesthesia machine to the active waste gas disposal system of the
5-17
 hospital.

5.6 Assemble the Anesthesia Vaporizer

Anesthesia machine is applicable to Anesthesia Vaporizer Draeger series of Selectatec®
(registered trade mark Ohmeda) fixation and interlocking mechanism for non-flammable
anesthesia gas.

Warning
 If the vaporizer is incompatible with the anesthesia machine, their performance may be
degraded. Please use the vaporizer matching the equipment.

 Please use an anesthesia vaporizer that complies with the ISO 80601-2-13 standard. For
installation, addition, discharge, and other information about the anesthesia vaporizer, see
the instructions of the manufacturer of the anesthesia vaporizer.

 The position of the anesthesia vaporizer between “0” and the minimum scale above “0” is not
available and may cause accidental injury to the patient.

 Care should be taken to lift and operate the anesthesia vaporizer during installation,as the
weight of the anesthesia vaporizer may be greater than expected,depending on the size of the
anesthesia vaporizer.

 Only Selectatec series vaporizers can be used. To conduct testing, ensure that the anesthesia
vaporizer is already locked up.

 Do not remove the locked 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 anesthesia machine 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 used, so as to monitor the output of anesthesia
concentration.

 The anesthetic vaporizer cannot be used if it is set between “0” and “ON”.

Caution

 For details of vaporizer assembling/running, refer to instruction manual of corresponding

vaporizers.

5-18
  Atmospheric pressure may differ from the calibration pressure of the anesthesia
vaporizer,which may lead to inaccurate anesthetic output.During the use of the anesthetic
system, the operator should continuously monitor the anesthetic concentration to confirm the
accurancy of the output concentration.

 If the top of anesthesia vaporizer is not horizontal, remove the anesthesia vaporizers and
reassemble it. If the anesthesia vaporizer cannot be set horizontally onto the vaporizer base,
do not use the system.

 Set the locking bar of anesthesia vaporizer to its locking position.

 Lift each anesthesia vaporizer upward in so far as possible such that it may be separated
from the vaporizer base. However, do not pull it forward. Be careful! Do not allow the
anesthesia vaporizer to rotate on the vaporizer base.

5.6.1 Assemble the Anesthesia Vaporizer

In the following assembling steps, anesthesia evaporator Draeger Vapor 2000 is given as an
example:

1. Hang the Anesthesia Vaporizer onto the vaporizer base of the anesthesia machine, and ensure that
the Anesthesia Vaporizer completely fits the vaporizer base without gap, as shown in the figure
below:

2. Turn clockwise the locking bar to fix the Anesthesia Vaporizer onto the vaporizer base, as shown in
the figure below:

5-19
 3. Ensure that top of the Anesthesia Vaporizer is horizontal. If not, remove the vaporizer and reinstall
it.
4. To reinstall it, lift up each Anesthesia Vaporizer vertically (90 degrees) such that it is separated
from the vaporizer base, but do not pull it forward. Be careful not to allow the Anesthesia Vaporizer
to rotate on the vaporizer base.
5. When the Anesthesia Vaporizer is separated from the vaporizer base, reinstall the vaporizer and
perform steps 1~3. If the Anesthesia Vaporizer cannot be positioned horizontally on the vaporizer
base, 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 reinstall the anesthesia vaporizers , and perform steps 1 to 6.

5.6.2 Fill the Anesthetics

For filling of anesthetics, please refer to specification sheets attached to the Anesthesia
Vaporizers.

Warning
Ensure that anesthetics are filled correctly. Anesthetic names are already indicated on the
vaporizers, and they are also marked with different colors. If anesthetics are incorrectly
filled, the actual output concentration of anesthetics may be changed.

5.6.3 Drain the Anesthetics

For drain of anesthetics, please refer to specification sheets attached to the anesthesia
evaporators.

Warning
 Anesthetics drained from the vaporizer must not be reused, and it shall be disposed as
hazardous chemicals.

 Please mark the bottles containing the drained anesthetics as follows: used anesthetics.

5.7 Assemble the Gas Cylinders

Warning

5-20
  Failure to use a washer or using two or more washers may result in leakage.

 During pipeline gas supply is in use; do not set the backup cylinder valve to position “ON”.
Otherwise, the gas cylinder may be exhausted and result in short supply in case the pipeline
ventilation gets faulty.

5.7.1 Gas Cylinder (1)

Install or replace the gas cylinder as follows:

1. Turn clockwise the handle of gas cylinder valve to turn off the valve of the gas cylinders to
be replaced.

Handle of cylinder valve

2. Unscrew the T-type handle anticlockwise.

T-type handle

3. Loosen T-type handle completely, and open the buckle.

5-21
 4. Remove the gas cylinder, and remove the old washer.

Washer

5. Ensure gas cylinder outlet is kept away from all articles that may be damaged by released
high pressure gas.

6. Turn on and off the gas cylinder valve quickly to remove the dust on the gas cylinder outlet.

7. Assemble the new composite sealing washer.

8. Align the positions of gas cylinder and index pin.

9. Close the buckle and tighten the T-type handle.

10. Test the gas cylinders. For specific steps, refer to “4.2.2 Backup Gas Cylinder Test”

5.7.2 Gas Cylinder (2)

1. Get the wrench for the gas cylinder valve.

2. Shut off the valve of the gas cylinder to be replaced.

3. Loosen the T-type handle completely.

5-22
4. Open the buckle.

5. Remove the gas cylinder and the old sealing washer.

6. Remove the screw cap on the valve of the new gas cylinder.

7. Ensure that the gas cylinder outlet is kept away from any articles that may be damaged by
released high pressure gas.

8. Turn on and off the gas cylinder valve quickly to remove the dust on the gas cylinder outlet.

9. Assemble the new composite sealing washer.

10. Align the gas cylinder and index pin.

11. Close the buckle and tighten the T-type handle.

12. Assemble gas cylinder plugs and composite sealing washers to all gas cylinder buckles.

13. Perform high pressure leak testing. For specific steps, refer to “4.2.2 Backup Gas Cylinder
Test”

5-23
5.8 Assemble Module

5.8.1 Assemble Sidestream AG 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.

5-24
4. Insert one end of the exhaust tube into the exhaust
outlet on the module, and rotate it clockwise to tighten
it.

5. 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.

6. Insert the sampling line into the sampling port.

5-25
5.8.2 Assemble Sidestream CO2 Module

For details, please refer to the section of " 5.8.1 Assemble Sidestream AG Module ".

5.8.3 Install the Sidestream AG + O2 Module

For details, refer to the section of 5.8.1 Assemble Sidestream AG Module.

5.8.4 Assemble Mainstream CO2 Module

1. Install the module into the module 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. The indicator light on the module turns on, indicating the
module is installed properly.

5-26
 3. According to the triangular mark of the connector, insert one end of the connector into the
sample port.

5.8.5 Assemble Artema Sidestream AG Module

1. Push the watertrap firmly into the watertrap socket as shown the figure below.
A "click" sound indicates that the watertrap is installed in place.

5-27
2. Install the module into the module slot.

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

5-28
 4. Insert one end of the exhaust tube into the exhaust outlet on the module, and rotate it clockwise
to tighten it.

5. 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.

6. Insert one end of the sampling tube into the sampling tube port, then rotate it clockwise to tighten
it.

5-29
5.8.6 Assemble Artema Sidestream AG+O2 Module

For the detailed installation procedure, refer to 5.8.5Assemble ARTEMA Sidestream AG Module.

5.8.7 Assemble BIS module

1. Firstly, paste the BIS sensor (as instructed in the attached document of the BIS sensor) onto the
patient's head.
2. Plug the sensor connector into the BISx device cable connector.

3. Plug the BISx device cable connector into the BIS module connector,
as shown in the figure:

5-30
 4. Push the module into the place until the lever at its bottom gives a “Click” sound, indicating that
the module is fixed properly.

5. The indicator light on the module turns on, indicating the module is installed properly.

5.8.8 Disassemble Sidestream AG Module

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

5-31
 2. Press down the clip at the exhaust outlet of the anesthesia
machine to pop out the exhaust tube, and then remove the
tube, as shown in the tight figure.

3. Rotate the tightening knob of the exhaust tube

anticlockwise , and then pull out the tube.

4. Push the tab at the bottom of the module upwards, and pull
out the module.

5.8.9 Disassemble Sidestream CO2 Module

For details, please refer to the section of " 5.8.8 Disassemble Sidestream AG Module ".

5-32
5.8.10 Disassemble Sidestream AG + O2 Module

For details, please refer to the section of " 5.8.8 Disassemble Sidestream AG Module ".

5.8.11 Disassemble Mainstream CO2 Module

1. Pull the connector cable out of the sampling port.

2. Push the tab at the bottom of the module upwards, and pull out the module.

5.8.12 Disassemble Artema Sidestream AG Module

1. Rotate the sample tube anticlockwise. As shown in the figure:

5-33
2. Press down the clip at the exhaust outlet of the anesthesia machine to pop out the exhaust tube,
and then remove the tube, as shown in the tight figure

3. Rotate the tightening knob of the exhaust tube counterclockwise , and then pull out the tube.

4. Push the tab at the bottom of the module upwards, and pull out the module.

5-34
 5. Push the buckle upwards as shown in the figure to remove the watertrap.

5.8.13 Disassemble Artema Sidestream AG+O2 Module

Please refer to 5.8.12 Disassemble Artema Sidestream AG Module for detailed disassembling steps.

5.8.14 Disassemble BIS module

1. Push the tab at the bottom of the module upwards, and pull out the module.

5-35
 2. Pull the BIS module cable connector out of the BIS module connector,
as shown in the figure:

3. Press and hold the circular button on the patient interface cable with right hand.
Pull out the sensor connector with left hand, as shown in the figure:

5.9 Vacuum Suction System

5.9.1 Installation of External Vacuum Suction

1、 As shown in the figure, connect the backup oxygen supply hose to the O2 supply port (in case of
air-driven, use backup air supply hose).

5-36
2、 Fix the bracket by tightening the screws at the four corners.

3、 Fix external vacuum suction by tightening the four screws on the bracket.

5-37
4、 Connect the other end of the backup oxygen supply hose to the external negative pressure
suction port and tighten the nut to fasten it.

5-38
5.10 AGSS Transfer and Receiving System

Warning
 AGSS transfer and receiving system shall work with a breathing system conforming to ISO
80601-2-13.

 Processing system shall be 1 H-type low-vacuum high-flow negative pressure suction system.

5.10.1 Structure Composition of AGSS

2 7

6
3

5
4

No. Notes
1 Waste gas exhaust nozzle connector
2 AGSS exhaust gase outlet
3 Transfer system hose conical connector
4 Pressure Compensation Port
5 Main body of AGSS system
6 Float (red)
7 Flow regulation knob

5-39
5.10.2 Assemble the AGSS

1 Assemble the waste gas exhaust nozzle connector to the gas outlet of breathing system：

2 Hang a AGSS system onto the AGSS bracket.

3 Connect the transfer system hose to the waste gas exhaust nozzle connector.

4 Connect the 30mm conical connector of transfer system hose to the inlet of AGSS system.

5-40
 4

5 Connect the AGSS exhaust gas outlet to the exhaust gas disposal system of the hospital through
AGSS active scavenging hose.

Caution

Do not block the pressure compensation port during the process of assembling and using AGSS.

Prior to transport or movement, remove the AGSS system from the anesthesia machine.

5.10.3 Effluent gas treatment system

1 AGSS transfer and receiving system is 1H-type high-flow low-vacuum model, and conforms to
Standard ISO 80601-2-13. The adjustable range of pump rate of the AGSS transfer and receiving
system is 50 ~80 L/min.
2 The AGSS transfer and receiving is a 1L-type low flow low vacuum type, and conforms to ISO
80601-2-13 standards. The adjustable range of pump rate of the AGSS transfer and receiving system
is 25 ~50 L/min.
5-41
3 Prior to use, verify that the waste gas disposal system is a high-flow disposal system, and is
able to reach the flow range.

4 Prior to use, verify that connector of the waste gas disposal system is BS 6834 standard
connector.

Caution

 During testing, do not block the pressure compensation port of the AGSS transfer and
receiving system.

Warning
 The AGSS transfer and receiving system cannot be used with flammable Anesthesia gases.

 If the hose between waste gas disposal system and AGSS is blocked, or the extract flow of
the waste gas disposal system is insufficient, exhaust gas from the expiratory system exceeds
the tidal volume 1L specified in ISO 80601-2-13, or exceeds the required semi-sine gas flow
of 20 times/minute, or the waste gas disposal system fails to work, gas inside the AGSS may
exceed 100 mL/min and overflow into the atmosphere. In such a case, it is inadvisable to use
the AGSS.

5-42
 Chapter6 Alarm

6.1 Overview
Alarms given by the anesthesia machine have the audible and visual indications to the medical
care personnel when the patients using the anesthesia machine show abnormal changes in vital
signs or the anesthesia machine can not work normally due to its fault.

Caution

 When the equipment is turned on, the system tests the alarm tones and alarm lamp
functions if they can work normally. If yes, the equipment gives a sound “Beep”, and the
alarm lamp blinks once in red and yellow each. If the tones and alarm lamp functions are
abnormal, do not use the equipment. Please contact the Company immediately.

 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 only rely on the audible alarm system for patient monitoring. If the alarm tone is
adjusted to a lower volume, patients’ safety 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 screen of the
equipment are for clinicians’ reference only, and must not be directly used as basis for
clinical treatment.

 A potential hazard can exist if different alarm pre-sets are used for the same or similar
equipment in any single area.

 Alarm system could restore the previous alarm setting no matter the duration of power
interruption.

6.1.1 Alarm Types

Alarms given by the anesthesia machine are divided into physiologic alarms, technical alarms and
prompting messages as per the properties of alarms.
1 Physiological Alarms
Physiological alarms are usually given when the physiological parameter measurement of the

6-1
 patient exceeds the preset High/Low alarm limits or some physiological abnormality of the patient
takes place. The alarm messages of physiological alarms are displayed in the physiological alarm
area at the upper part of the screen.
2 Technical Alarms
Technical alarms, which are also known as system error messages, indicate the alarms triggered
when some system function cannot work normally resulting from misoperation or system
malfunction, or the monitoring results are distorted. Alarm messages of technical alarms are
displayed in the technical alarm area at the upper part of the screen.
3 Prompting Messages
Strictly speaking, prompting messages do not fall into the scope of alarms. Apart from the
physiological alarm messages and technical alarm messages, the Anesthesia machine can display
prompting messages which are related to the system state.. The prompting messages usually do
not relate to the vital signs of patients. The prompting messages are displayed in the system
prompting message area.

6.1.2 Alarm Levels

As per the severity of alarms, physiological alarms given by the anesthesia machine are divided into
high level alarms, medium level alarms, and low level alarms.
1 High Level Alarms
Patient is in a critical condition endangering patient life, and immediate emergency treatment is
required.
2 Medium Level Alarms
Physiological sign of patient appears abnormal, and corresponding measures shall be taken or
treatment shall be conducted immediately.
3 Low Level Alarms
Physiological sign of patient appears abnormal, and corresponding measures may possibly be
taken or treatment may possibly be conducted.
Levels of all technical alarms and some physiological alarms are already preset before the
anesthesia machines are shipped, and cannot be modified by the users. Levels of some
physiological alarms may be modified.

6.2 Alarm Indications

When an alarm occurs, the anesthesia machine prompts the user through the following audible
and visual indications:

6-2
 Visual alarms

Audible alarms

Alarm messages

Parameter flashing

Of which, the alarm levels of visual alarms, audible alarms and alarm messages are presented
in different ways respectively.

6.2.1 Visual Alarms

When an alarm occurs, alarm lamp prompts alarms of different levels by different colors and
flashing frequencies.

High level alarms: red, the flashing frequency is 2.5Hz.

Medium level alarms: yellow, the flashing frequency is 0.625Hz.

Low level alarms: yellow, always on, without flashing.

6.2.2 Audible Alarms

When an alarm occurs, anesthesia machine prompts alarms of different levels by different
sound characteristics.

High level alarms: Di-Di- Di - Di - Di ----- Di - Di - Di - Di - Di.

Medium level alarm: Di - Di - Di.
Low level alarms: Di.
Information: Do

6.2.3 Alarm Messages

Alarm messages are displayed in the physiological alarm area or technical alarm area of
anesthesia machine when an alarm occurs. System adopts different background color to
differentiate levels of alarm messages.

 High level alarms: Red

 Medium level alarm: yellow

 Low level alarm: yellow

 Information : no background,except Module alarm off is yellow

6-3
 The following marks are added before alarm messages to differentiate level alarm messages:

 High level alarms: !!!

 Medium level alarm: !!

 Low level alarm: !

 Information: no “!”mark

6.2.4 Parameter Flashing

When a parameter alarm occurs, the parameter flashes once every second.

6.2.5 Alarm Status Icons

In addition to the above-mentioned alarm modes, the following alarm status icon may also be
displayed on the screen to indicate the alarm status.

: The icon indicates that alarm temporary sound is muted,temporary mute 120S

6.3 Set the Alarm Volume

1. On the screen, select [Alarm] →[Sound]→ Access [Alarm Sound Volume] menu.

2. Select a volume from the range of 1~8. “1” indicates the minimum volume, and “8”
indicates the maximum volume.

Warning
 When using the equipment, you cannot just depend upon audible alarms. If the alarm tone
is adjusted to a lower volume, the patient’s safety may be endangered. Keeping the patient
under close surveillance is the most reliable way.

 Minimum alarm sound volume can be adjusted in maintenance mode.

 Click on the system default, when the set minimum alarm volume is less than or equal to
level 5, the alarm volume is restored to level 5 when the default value is restored or when
the minimum alarm volume set is greater than level 5, the alarm volume is restored to the
minimum alarm volume when the default value is restored.

6.4 Set the Alarm Limits

6-4
 Caution

 When the parameter value is higher than high alarm limit or lower than low alarm limit ,
an alarm will be triggered.

 Click on the system default, the ventilator parameter alarm high and low limit is restored to
the default alarm high and low limit corresponding to the patient type.

 When using the equipment, always ensure that the alarm limits are set to suitable values.
Set High alarm limit and low alarm limit as per clinical requirements. If the settings are
beyond the valid range, the alarm system may be ineffective.

6.4.1 Set the Alarm Limits of Ventilator

1. On the screen, select [Alarm] menu → [ventilator] .

2. On the alarm screen of ventilator, set one by one the alarm [High Limit] and [Low limit]
of parameters like [MV] , [Ppeak] , [FiO2] and [VT] .

3. Or select [Load Default Alarm Limit] to use the default high/low alarm limits

Fig. 6-1 Set the Ventilator‟s Alarms

Range of High/Low alarm limits:

Adult default Child default Step

Parameter Name High Limit Low limit Unit
alarm alarm size

6-5
 0~ (High 1（low limit） 1（low limit）
MV 2~100 L/min 1
limit-2) 10（high limit） 5（high limit）

0~ (High 10（low limit） 8（low limit）

2~100 cmH2O 1
limit-2) 50（high limit） 40（high limit）

1.0（low limit） 0.8（low limit）

0～（High
Ppeak 0.2～9.8 kPa 0.1
limit－0.2） 4.9（high limit） 3.9（high
limit）

0～（High 10（low limit） 8（low limit）

2～98 mbar 1
limit－2） 49（high limit） 39（high limit）

21（low limit） 21（low limit）

18~ (High
FiO2 20~105 103（high 103（high % 1
limit-2)
limit） limit）

5（low limit） 5（low limit）

0~ (High
VT 5~1600 1000（high 200（high mL 5
limit-5)
limit） limit）

Warning
 If an alarm is cleared in manual mode, alarms such per-minute ventilation amount and
expiratory tidal volume will not be triggered.

 The alarm setting can be saved before and after shutdown for 30S,and the setting before
shutdown can be maintained.

6-6
6.4.2 Set the CO2 Alarm Limits

1. On the screen, select [Alarm] menu → [CO2] .

2. On the alarm screen of CO2, set the [High Limit] and [Low Limit] for [FiCO2] and [EtCO2]
alarms, as shown in the figure below:

Fig. 6-2 Set the Carbon Dioxide Alarms

Range of High/Low Alarm Limits:

Respironics CO2：

Paramete Adult default Child default Step Remar

High limit Low limit Unit
r Name alarm alarm size ks

0（low limit）
(low 0～74 0（low limit）
FiCO2 limit+1)～ 4（high limit） mmHg 1 N/A
76 4（high limit）

25（low limit）
(low 0～（high
25（low limit）
EtCO2 limit+2)～ limit-2） 50（high mmHg 1 N/A
150 50（high limit）
limit）

Masimo CO2：

Paramete Adult default Child default Step Remar

High limit Low limit Unit
r Name alarm alarm size ks

6-7
 0（low limit）
(low 0～97 0（low limit）
FiCO2 limit+1)～ 4（high limit） mmHg 1 N/A
4（high limit）
99

25（low limit）
(low 0～（high 25（low limit）
EtCO2 limit+2)～ limit-2） 50（high mmHg 1 N/A
50（high limit）
190 limit）

6.4.3 Setting BIS Warning Limits

1. On the screen, select [Alarm] menu → [BIS] .

2. On the alarm screen of BIS, set the [High Limit] and [Low Limit] for [BIS] alarms, as shown
in the figure below:

Paramete Adult default Child default Step Remar

High limit Low limit Unit
r Name alarm alarm size ks

BIS 2～100 0～98 20（low limit） 20（low limit） / 1

N/A
70（high limit） 70（high limit）

6-8
6.4.4 Setting the AG Alarm Limits

1. On the screen, select [Alarm] menu → [AG].

2. Set the [High Limit] and [Low Limit] of the parameters of [FiN2O] , [EtN2O] , [FiAA] and
[EtAA] on the [AG] Alarm screen. See the following figure:

Fig. 6-3 Setting Anesthetic Gas Alarm

Range of the High/Low alarm limit:

Adult default Child default R

Step
Name High Limit Low Limit alarm alarm Unit emark
size
s
(Low Limit ＋ 0～(High Limit 0（low limit） 0（low limit） mmH N/A
FiCO2 1
2）～99 －2) 4（high limit） 4（high limit） g
(Low Limit ＋ 0～(High Limit 25（low limit） 25（low limit） mmH N/A
EtCO2 1
2）～190 －2) 50（high limit） 50（high limit） g
0（low limit） 0（low limit） N/A
(Low Limit ＋ 0 ％ ～ (High
FiN2O 53（high limit） 53 （ high %1
2%）～100% Limit－2%)
limit）
0（low limit） 0（low limit） N/A
(Low Limit ＋ 0 ％ ～ (High
EtN2O 55（high limit） 55 （ high %1
2%）～100 % Limit－2%)
limit）

6-9
 0（low limit） N/A
0（low limit）
Inhalation (Low Limit ＋ 0 ％ ～ (High 2.0（high limit）
% 0.1
of AA 0.2%）～25.0 % Limit－0.2%) 2.0 （ high
limit）
0（low limit） 0（low limit） N/A
Exhalatio (Low Limit ＋ 0 ％ ～ (High
5.0（high limit） 5.0 （ high % 0.1
n of AA 0.2%）～25.0% Limit－0.2%)
limit）

6.5 Set the Alarm Levels

Set CO2 alarm level:

1. Select [Alarm] menu → [CO2] → [Alarm Level]..

2. The [High Limit ] of CO2 alarm levels can be set to, [Medium],default [Medium],not modifiable.

Set AG alarm level:

1. Select [Alarm] menu → [AG] → [Alarm Level].
2. The [High Limit ] and [Low Limit] of AG can be distinguished as follows:
 EtN2O high limit alarm（High,Medium,Low）
 EtAA high limit alarm（High,Medium）
 AG FiAA ,FiN2O the high limit is Medium alarm
 AG FiAA,FiN2O the low limit is low alarm
Set BIS alarm level:
1. Select [Alarm] menu → [BIS] → [Alarm Level].
2. Set the [High Limit ] of BIS to [High] , [Medium] or [Low].

6.6 Alarm pause

6.6.1 Set the Alarm Pause

Push the alarm pause key to set the system to alarm pause status, namely all alarm tones of
the system are shielded, and “ ” icon and 120 s counting-down are displayed in the upper
right corner of the screen.

Caution

 In the alarm pause status, all alarm modes works normally except for audible alarm.

 In alarm pause status, even if there is a newalarm pause technical or physiological

6-10
 alarm,the alarm will continue to be suspended.

 Once 120s counting down expires, the system will automatically exit the current alarm
pause status and reactivate the audible alarm.

6.6.2 Canceling the Alarm pause

If the alarm pause soft key is pushed, the system will exit current alarm pause status and
reactivate audible alarm, and the alarm pause icon and 120s counting down displayed in upper
right corner of the screen disappear simultaneously.

6.7 Setting the Alarm Switch

Set the CO2 module alarm switch:
1. Select the [Alarm] menu → [CO2].
2. Set the CO2 module alarm to [ON] or [OFF].
Set the AG module alarm switch:
1. Select the [Alarm] menu → [AG].
2. Set the AG module alarm to [ON] or [OFF].
Set the BIS module alarm switch:
1. Select the [Alarm] menu → [BIS].
2. Set the BIS module alarm to [ON] or [OFF].

Caution
 When the anesthesia machine is completely powered off or turned off, the stored
module alarm switch may not be deleted.

6.8 Measures when an Alarm Occurs

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. Take measures to eliminate the alarm condition.

5. Check whether or not the alarm condition is corrected.

6-11
 For specific measures for each alarm, refer to “Chapter 7 Physiological Alarms and Technical
Alarms”.

6.9 Testing Alarm System

The alarm system includes three types of alarms, i.e. physiological alarm, technical alarm and
prompt message respectively. You can test the alarm system through the condition of visual alarm,
audible, parameter flashing and message. For example:
1. Make preparations according to the “Measuring Procedures and Testing” in Chapter CO2 ,
and enter the [CO2] Alarm screen to set [High Limit] and [Low Limit] of the parameters of
[FiCO2] , [EtCO2] as 15 mmHg and 6 mmHg respectively.
2. On the screen, select [Alarm] →enter the menu of [Sound] and [Indicate Sound
Volume] , and set the volume to “0~7”.
3. When the measured values exceed high limit and low limit of alarm, select [Alarm] →
[CO2] → [Alarm Level] , and set the [Alarm Level] to [High] and [Medium] respectively.
Observe the changes of sound, light and parameter flashing. See the contents of “Visual Alarms”,
“Audible Alarms”, “Parameter Flashing” in this chapter for details. Meanwhile, it indicates that
CO2 is too high or too low in the physiological alarm area.
4. In normal condition, when the measured values exceed the high limit or low limit of alarm,
the equipment will provide indications in the form of light, sound and message, and the average
delay of alarm does not exceed 5 seconds.
5. Pull out the sampling tube of CO2 from the anesthesia machine, and the following
message prompts out in the technical alarm area: Without Adsorption Tube.

Attention

 When several alarms are triggered at the same time, the system will only give the visual and
audible indications for the alarm of highest level.

6-12
 Chapter7 Physiological Alarms and Technical Alarms

Most of the essential physiological and technical alarm messages are listed in this chapter, however, some
alarm messages are not necessarily listed.

Caution

 In this chapter, H indicates high level, M indicates medium level, L indicates low level.

Corresponding measures are listed for each alarm message. In case the problem still exists after action is
taken, contact the service technician.

7.1 Physiologic Alarms

Alarm
Alarm messages Causes and Measures
level
Airway peak pressure (Ppeak) is higher than the set value of high alarm
High Paw H limit. Reduce the set value of tidal volume, or increase the set value of
upper Paw alarm limit.
Airway peak pressure Ppeak is lower than the set value of low Paw
Low Paw H alarm limit (lasting for 20 seconds). Increase the set value of tidal
volume, or reduce the set value of high Paw alarm limit.
MV value is higher than the high alarm limit. Reduce the tidal volume,
High MV M
slow the respiratory frequency, or increase the high alarm limit.
MV is lower than the low alarm limit. Increase the tidal volume,
Low MV M
increase respiratory frequency, or reduce the low alarm limit.
High VTexp H Expiratory Tidal Volume value is higher than high alarm limit. Reduce
the preset tidal volume or increase the high alarm limit.
Low VTexp H Expiratory Tidal Volume value is lower than low alarm limit. Increase
the preset tidal volume or reduce the low alarm limit.
FiO2 value is higher than high alarm limit. Reduce fresh-gas oxygen
High FiO2 M
flow or increase the high alarm limit.
FiO2 value is lower than the low alarm limit. Increase fresh-gas oxygen
Low FiO2 H
flow or reduce the low alarm limit.
Two (2) triggering conditions are satisfied simultaneously:
Apnea M
1. Airway pressure is continuously lower than (PEEP +3) cmH2O for
7-1
 Alarm
Alarm messages Causes and Measures
level
more than 30 seconds.
2. Expiratory tidal volume is continuously lower than 10ml for more
than 30 seconds.
Increase the set values of tidal volume and respiratory frequency, or set
it to Manual/spontaneous mode.
No respiration takes place within the latest 120 seconds. Check status of
Apnea>2min H the patient. Use Manual/spontaneous mode to aid the patient to breathe.
Check whether or not any pipeline drops out.
Paw value is higher than Plimit. Increase the Plimit or reduce the tidal
Pressure Limiting L
volume or the respiratory rate.
Continuous Pressure H In the respiratory circuit, Paw value is higher than the continuous
airway pressure. If the continuous airway pressure is too high, the
equipment reports an alarm lasting for 15 seconds.
Pressure is 10cmH2O lower than the atmosphere. Check whether or not
the patient is conducting autonomous respiration. Increase the fresh gas
Negative Pressure H flow. Check whether or not there is high air flow through the
scavenging system. If yes, check the negative pressure relief valve on
the receiver.
Apnea Ventilation M Can not detect patient‟s respiration over the set Apnea time, and the
ventilation for Apnea is undergoing. Check patient‟s respiration or
increase the setting of Apnea time.
High EtCO2 M EtCO2 concentration is higher than the alarm high limit. Increase the
high limit of the alarm setting.
Low EtCO2 M EtCO2 concentration is lower than the alarm low limit. Reduce the low
limit of the alarm setting.
High FiCO2 M FiCO2 concentration is higher than the alarm high limit. Increase the
high limit of the alarm setting.
Low FiCO2 M FiCO2 concentration is lower than the alarm low limit. Reduce the low
limit of the alarm setting.
High FiO2 M (When using the module with paramagnetic oxygen sensor) FiO2 value
is higher than the alarm high limit. Decrease the O2 flow in the fresh air
or increase the high limit of the alarm setting.
Low FiO2 M (When using the module with paramagnetic oxygen sensor) FiO2 value
is lower than the alarm low limit. Increase the O2 flow in the fresh air or
7-2
 Alarm
Alarm messages Causes and Measures
level
reduce the low limit of the alarm setting.
High EtN2O M EtN2O concentration is higher than the alarm high limit. Decrease N2O
flow or increase the high limit of the alarm setting.
Low EtN2O M EtN2O concentration is lower than the alarm low limit. Increase N2O
flow or reduce the low limit of the alarm setting.
High FiN2O M FiN2O concentration is higher than the alarm high limit. Decrease N2O
flow or increase the high limit of the alarm setting.
Low FiN2O M FiN2O concentration is lower than the alarm low limit. Increase N2O
flow or reduce the low limit of the alarm setting.
High EtHAL M EtHAL concentration is higher than the alarm high limit. Decrease HAL
flow or increase the high limit of the alarm setting.
Low EtHAL M EtHAL concentration is lower than the alarm low limit. Increase HAL
flow or reduce the low limit of the alarm setting.
High FiHAL M FiHAL concentration is higher than the alarm high limit. Decrease HAL
flow or increase the high limit of the alarm setting.
Low FiHAL M FiHAL concentration is lower than the alarm low limit. Increase HAL
flow or reduce the low limit of the alarm setting.
High EtENF M EtENF concentration is higher than the alarm high limit. Decrease ENF
flow or increase the high limit of the alarm setting.
Low EtENF M EtENF concentration is lower than the alarm low limit. Increase ENF
flow or reduce the low limit of the alarm setting.
High FiENF M FiENF concentration is higher than the alarm high limit. Decrease ENF
flow or increase the high limit of the alarm setting.
Low FiENF M FiENF concentration is lower than the alarm low limit. Increase ENF
flow or reduce the low limit of the alarm setting.
High EtISO M EtISO concentration is higher than the alarm high limit. Decrease ISO
flow or increase the high limit of the alarm setting.
Low EtISO M EtISO concentration is lower than the alarm low limit. Increase ISO
flow or reduce the low limit of the alarm setting.
High FiISO M FiISO concentration is higher than the alarm high limit. Decrease ISO
flow or increase the high limit of the alarm setting.
Low FiISO M FiISO concentration is lower than the alarm low limit. Increase ISO
flow or reduce the low limit of the alarm setting.

7-3
 Alarm
Alarm messages Causes and Measures
level
High EtSEV M EtSEV concentration is higher than the alarm high limit. Decrease SEV
flow or increase the high limit of the alarm setting.
Low EtSEV M EtSEV concentration is lower than the alarm low limit. Increase SEV
flow or reduce the low limit of the alarm setting.
High FiSEV M FiSEV concentration is higher than the alarm high limit. Decrease SEV
flow or increase the high limit of the alarm setting.
Low FiSEV M FiSEV concentration is lower than the alarm low limit. Increase SEV
flow or reduce the low limit of the alarm setting.
High EtDES M EtDES concentration is higher than the alarm high limit. Decrease DES
flow or increase the high limit of the alarm setting.
Low EtDES M EtDES concentration is lower than the alarm low limit. Increase DES
flow or reduce the low limit of the alarm setting.
High FiDES M FiDES concentration is higher than the alarm high limit. Decrease DES
flow or increase the high limit of the alarm setting.
Low FiDES M FiDES concentration is lower than the alarm low limit. Increase DES
flow or reduce the low limit of the alarm setting.
H BIS value is higher than the alarm high limit. Check the anesthetics
High BIS
supply. Increase the anesthetics flow rate or alarm high limit.
H BIS value is lower than the alarm low limit. Check the anesthetics
Low BIS
supply. Reduce the anesthetics flow rate or alarm low limit.

7.2 Technical Alarms

7.2.1 Monitor wafer Alarms

Alarm
Alarm messages Causes and Measures
level
No calibration data was found in memory or the calibration data did not
Calibrate Flow
L match. Use Manual/spontaneous mode to assist patient to breathe.
Sensor
Calibrate the flow sensor.
Calibrate Pressure No calibration data was found in memory or the calibration data did not
L
Sensor match. Use Manual/spontaneous mode to assist patient to breathe.

7-4
 Alarm
Alarm messages Causes and Measures
level
Calibrate the pressure sensor.
No calibration data was found in memory or the calibration data did not
Calibrate O2 Sensor L
match. Calibrate or replace oxygen sensors.
Three way valve 12V,safety valve 5V,proportional valve 7.5V,internal
AD reference voltage 3.3V and external AD reference voltage 2.5V,at
Power Failure H
least one way power supply failure. Use Manual/spontaneous mode to
assist patient to breathe. Contact the manufacturer for service.
Self Check Error L MCU hardware error. Contact the manufacturer for service.
Watchdog Failure The external watchdog is burnt out and out of order. Please contact the
H
manufacturer for service.
Internal A/D The internal ADC is out of order. Please contact the manufacturer for
H
Converter Failure service.
External A/D The external ADC is out of order. Please contact the manufacturer for
H
Converter Failure service.
Connection or control of zero valve gets faulty. The device can still
Zero Valve Failure L work, but the monitoring is unreliable. Use manual/spontaneous mode
to aid the patient to breathe if necessary.
Connection or control of expiratory valve is faulty. Use
Expiration Valve
M Manual/spontaneous mode to assist patient to breathe. Please contact
Failure
the manufacturer for service.
Flow Valve Failure M There exists connection or control failure in the flow valve. Use
Manual/spontaneous mode to assist patient to breathe. Please contact
the manufacturer for service.
M Connection of safe valve is faulty. Use Manual/spontaneous mode to
Safe Valve Failure
assist patient to breathe. Please contact the manufacturer for service.
Safe Valve Control Connection or control of safe valve is faulty. Use Manual/spontaneous
H
Failure mode to assist patient to breathe.
Pressure of oxygen supply is inadequate. Make sure O2 supply of
No O2 Pressure H adequate pressure is connected;If an air supply is connected, you may
use Manual/spontaneous to aid the patient to breathe.
Breathing system is not assembled, or the connecting wires of breathing
No Breathing
H system mounting are connected incorrectly. Contact the manufacturer
System
for service.
O2 Flush Failure M The button of “O2 Flush”cannot be pressed down. Or the oxygen flush
7-5
 Alarm
Alarm messages Causes and Measures
level
cannot be started after the button is pressed down. Contact the
manufacturer for service.

ACGO in Use L The ACGO is being used. Check the cover condition of ACGO.

Oxygen sensor is not or poorly connected to the cable. Ensure that

Connect O2 Sensor L
oxygen sensor and cables are connected.
Replace Oxygen M Oxygen sensor exhaustion or gets faulty. Replace the oxygen sensor.
Sensor
Flow sensor breathe in or breathe out beyond the range. The device can
Flow Sensor Failure L
still work, but its accuracy is low. Calibrate or replace the flow sensor.
The inhalation or exhalation sensor has reverse flow, check the flow
Check Flow Sensor H
sensor.
Pressure Sensor Failure of pressure sensor or abnormal at zero. Use Manual/spontaneous
M
Failure mode to assist patient to breathe.
M Leakage is detected in the breathing system. Check the connection of
Patient Circuit Leak
breathing system and flow sensors.
Pinsp Not Achieved L The inspiratory pressure does not reach the set value. Check whether
there is gas leakage, whether the gas supply pressure is normal, and
whether the expiratory valve and proportional valve work properly.
L The expiratory tidal volume does not reach the set tidal volume. Check
VT Not Achieved
patient‟s condition, and inspect airway connection and flow sensor.
Breathing System The circuits of the heating module is faulty. Contact the manufacturer
L
Heater Failure for service.
Power Supply Fan M Power fan is disconnected, or the fan is faulty. Check the fan connection
Stat and condition. Contact the manufacturer for service.
CPU Failure Abnormal software reset or power failure. Please contact the
H
manufacturer for service.
CPU Temperature The CPU temperature is too high. Please contact the manufacturer for
M
Abnormal service.
UCOS Error The software is out of order. Please contact the manufacturer for
L
service.
Monitor
Communication failure between monitor board and backup CPU.The
Communication Fail H
serial line is not connected or the chip of the serial port is broken.
With Bk CPU

7-6
 Alarm
Alarm messages Causes and Measures
level
Bk CPU
Communication failure between backup CPU and host.
Communication H
The serial line is not connected or the chip of the serial port is broken.
Failure With Host
Host
Communication failure between backup CPU and host.
Communication Fail H
The serial line is not connected or the chip of the serial port is broken.
With Bk CPU
Host H Communication failure between monitor board and host.
Communication The serial line is not connected or the chip of the serial port is broken.
Failure With
Monitor
Key Board Failure Communication failure between key board and host.
H
The serial line is not connected or the chip of the serial port is broken.

7-7
7.2.2 Flowmeter Alarms

Alarm
Alarm messages Causes and measures
level
Oxygen flow sensor cable failure or sensor failure.
O2 Sensor Failure L
Please contact the manufacturer for service.
N2O flow sensor cable failure or sensor failure.
N2O Sensor Failure L
Please contact the manufacturer for service.
Air flow sensor cable failure or sensor failure.
Air Sensor Failure L
Please contact the manufacturer for service.
Flowmeter M
Electronic flowmeter fails to communicate with the host normally.
Communication
Please contact the manufacturer for service.
Failure
Fresh gas is less than 200mL/min.
No Fresh Gas M Increase fresh gas flow.If alarm fails to eliminate,please contact the
manufacturer for service.
O2-N2O Ratio Oxygen flow sensor or nitrous oxide gas flow sensor failure. Please
H
Error contact the manufacturer for service.
The oxygen flow is greater than 15L/min,lower the oxygen flow.If the
High O2 Flow L
alarm cannot be eliminated, please contact the manufacturer for service.
The AIR flow is greater than 15L/min,lower the AIR flow.If the alarm
High Air Flow L
cannot be eliminated, please contact the manufacturer for service.
High N2O Flow The N2O flow is greater than 15L/min,lower the N2O flow.If the alarm
L
cannot be eliminated, please contact the manufacturer for service.

7-8
7.2.3 Battery Alarms

Alarm
Alarm messages Causes and measures
level
The battery charge is low. The system can be operated. Connect
Low Battery alternating current immediately. In case of power cut-off, use
H
Voltage Manual/spontaneous to aid the patient to breathe. If the battery cannot
be fully charged within 24 hours, contact the manufacturer for service.
If voltage of batteries is lower than 10.6V and AC is not connected,
System Down For connect AC supply immediately. In case of power cut-off, use
H
Battery Depletion Manual/spontaneous to aid the patient to breathe. If the battery cannot
be fully charged within 24 hours, contact the manufacturer for service.
Battery is not assembled, or the battery cable is disconnected with
No Battery M
power module. Please contact the manufacturer for service.
On Battery Power L Battery is in use. Please check the AC power connection status.

7.2.4 AG Module Alarms

Alarm messages Alarm Causes and measures

level
AG Init Error H Error AG occurs in the AG module initializing process. Restart the
Monitor to try again. If the error still exists, contact us for service.
AG Comm Stop H The AG module fails to communicate with the main system. Restart the
Monitor to try again. If the error still exists, contact us for service.
AG Comm Error H The AG module fails to communicate normally with the main system.
Restart the Monitor to try again. If the error still exists, contact us for
service.
AG Alm Lmt Err L The alarm limit of parameter AG is accidentally changed. Contact us for
service.
AG overrange L The measured value of parameter AG goes beyond the specified
measurement range. Contact us for service.
AG Start Zeroing L AG analyzer is in calibration.Waiting for zero correction to end.
Need Air Calibrate L Oxygen sensor need be calibrated in air.Calibrate oxygen sensor in 21%
air.

7-9
Need O2 Span L Oxygen sensor need to be calibrated in pure oxygen. Calibrate oxygen
Calibrate sensor in pure oxygen. If user can‟t meet the requirement, please return
it back to factory.
O2 Sensor Error L Module fails. Reseat oxygen sensor orreboot.
O2 Port Failure L
Hardware H
Error,Replace
Sensor
Sampling tube blocking. Check and replace the
AG Sampling Line
L sampling tube, if the faultpersists, please contact themanufacturer for
Clogged
maintenance.

Sampling tube is not connected or in badcontact. Check and replace the

AG No Sampling
L sampling tube, if the faultpersists, please contact themanufacturer for
Line
maintenance.

Adapter abnormal. check and replace the adapter,if fault persists, please
Replace AG
M contactthemanufacturer for
Adapter
maintenance.
L Adapter is not connectedor in bad contact. Check and replace the
AG No Adapter
adapter,if fault persists, please contactthemanufacturer for maintenance.
CO2 Outside L
Specified Accuracy
Range
O2 Outside L
Specified Accuracy The measured valueexceeds the claimed scope of accuracy. Please
Range follow the precisionrange of measurement claimed
N2O Outside L by manufacturers.
Specified Accuracy
Range
AX Out Of L

7-10
Accuracy Range
Temp Out Of Range L
Atmospheric
M
Pressure Beyond
L
Module fails. Return to factory for
AG Speed Out Of maintenance.
Bounds

AG Factory L
Calibration Lost
Zero reference L AG Analyzer requires zero. enter AG settings for zero Here zero is equal
calibration required to calibration.
AG L AG Analyzer does not recognize the existence of
Conc.Unreliable other gas. check the gas.
Replace O2 Sensor L Beyond usage time. Replace oxygen sensor.
AG Software Error L Software error occurs. Reboot
There is only one mainnesthetic gas waveformand value shown in
Found Two AG
M thekinds of anesthesia gasfor tips. Check the patient'sphysiological signs
Gases
andanesthesia.
AG Analyzer operatingmode is on standby. Measurement mode of AG
AG Is Sleeping L
Analyzer is selected.

7-11
7.2.5 CO2 Module Alarms

Alarm messages Alarm Causes and measures

level
CO2 Init Err H Error CO2 occurs in the CO2 module initializing process. Restart the
Monitor to try again. If the error still exists, contact us for service.
CO2Comm Stop H The CO2 module fails to communicate with the main system. Restart the
Monitor to try again. If the error still exists, contact us for service.
CO2 Comm Err H The CO2 module fails to communicate normally with the main system.
Restart the Monitor to try again. If the error still exists, contact us for
service.
CO2 Alm Lmt L The alarm limit of parameter CO2 is accidentally changed. Contact us
Err for service.
CO2 overrange L The measured value of parameter CO2 goes beyond the specified
measurement range. Contact us for service.
CO2 is sleeping L [Standby] is selected as the CO2 work mode. Select [Measure] as the
CO2 work mode.
CO2 Line L The sampling tube is clogged. Check and replace the sampling tube. If
Blocked the fault still exists, contact us for service.
CO2 No L The sampling tube is in poor contact or not connected. Check and
Sampling Line replace the sampling tube. If the fault still exists, contact us for service.
(Masimo)
CO2 Outside L The measured value goes beyond the specified accuracy range. Follow
Specified the specified accuracy range.
Accuracy Range
CO2 Temp Out L The module has a fault. Return to us for repair.
Of Range
CO2 Span L
Calibration Error
(Masimo)
CO2 Factory L
Calibration Lost
(Masimo)
CO2 Speed Out L
Of Bounds
7-12
(Masimo)
Atmospheric L
Pressure Beyond
(Masimo)
CO2 Span L The CO2 span is being calibrated. Return to us.
Calibrating......(
Masimo)
Replace CO2 L The adapter has a fault. Check and replace the adapter. If the fault still
Adapter exists, contact us for service.
(Masimo)
CO2 No Adapter L The adapter is in poor contact or not connected. Check and replace the
(Masimo) adapter. If the fault still exists, contact us for service.
CO2 Need Zero L The CO2 module needs zeroing. Enter [CO2 Setup] to select [Zero].
(Masimo)
CO2 Software L The software has a fault. Restart the Monitor.
Error (Masimo)
CO2 Hardware L The hardware has a fault. Check and replace the sensor. If the fault still
Error (Masimo) exists, contact us for service.

7.2.6 BIS Module Alarm Messages

Alarm Causes and measures

Alarm messages
level
H Error BIS occurs in the BIS module initializing process. Restart the
BIS Init Err
Monitor to try again. If the error still exists, contact us for service.
BIS COMM H The BIS module fails to communicate with the main system. Restart the
STOP Monitor to try again. If the error still exists, contact us for service.
H The BIS module fails to communicate normally with the main system.
BIS Comm Error Restart the Monitor to try again. If the error still exists, contact us for
service.
L The alarm limit of parameter BIS is accidentally changed. Contact us for
BIS Alm Lmt Err
service.
L The measured value of parameter BIS goes beyond the specified
BIS overrange
measurement range. Contact us for service.

7-13
 L BIS sensor is connected unreliably. Check if the BIS sensor is connected
BIS No Sensor
properly. If the fault still exists, contact us for service.
L Electrode of the sensor falls off or the skin is too dry. Check patient
impedance too
cable connection and check electrode-to-skin contact. If necessary, clean
high
and dry the skin.
IMPEDENCE L Prompt information for ten-minute ground electrode impedance check.
CHECKING No action necessary
H Data communication between monitor and BIS module stops.
BIS COMM
Reinitialize BIS module. If there is still malfunction, please contact the
STOP
manufacturer to maintain it.
L Sensor is out of its service life. The initialization of sensor can be still
BIS SENSOR conducted and the data waveform data and parameter can be also
EXPIRED captured. This alarm merely reminds the users that this sensor is out of
service life, but it depends on users whether to replace it.
INVALID BIS L Invalid sensor. Change Sensor
SENSOR
L During the process of initialization and monitoring, the sensor over
REPLACE THE
current and incorrect ground impedance have been detected by the
SENSOR!
system. Change Sensor.
POOR SIGNAL L Weak signal. SQI value is too low. Check the status of patient and the
QUALITY connection of sensor.
（SQI﹤50%）
BAD SIGNAL L Poor Signal. SQI value is too low. Check the status of patient and the
QUALITY connection of sensor.
（SQI﹤15%）

7.3 Prompt Information

7.3.1 The prompt message displayed in the alarm bar

Alarm messages Causes and countermeasures

BIS module alarm This information will appear when BIS module alarm is switched off.
closed
AG Module Alarm This information will appear when AG module alarm is switched off.
closed
7-14
 Alarm messages Causes and countermeasures
CO2 Module Alarm This information will appear when CO2 module alarm is switched off.
closed
This alarm will appear when the AG module is used and the CO2 module
CO2 Alarm closed
is closed.
Anesthesia module This information will appear when anesthesia module is in standby
standby status,
CO2 Module
This information will appear when CO2 module is in standby status,
Standby
VTexp Alarm, MV This information will appear when the manual/spontaneous switch is
Alarm and Apnea Alarm pressed to the manual and the alarm option is set to off.
closed!!

7.3.2 The prompt message displayed in the information bar

Alarm messages Causes and countermeasures

Set the Bag /Vent
This prompt message will appear when you switch to
switch to the "..."
manual/spontaneous mode without clicking OK.
position.
You can press the
This prompt message will appear when you switch to Mechanical
"Confirm" button switch
ventilation mode without clicking OK.
to "…"
Machine Ventilation This information will appear when the ACGO switch is turned on and an
Stop external gas outlet is used.
O2 Flush This prompt message will appear when you press O2 Flush button.
This prompt message will appear when the manual/spontaneous switch
Ventilate Manually
is pressed to the manual.

7-15
 Chapter8 CO2 Monitoring

8.1 Overview
CO2 monitoring function of the anesthesia machine adopts infrared absorption technology to
determine the CO2 concentration inside the respiratory circuits of the patient.. 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.

1. CO2 Measuring Methods:

Sidestream

Sample the respiratory gases inside the patient-respiration airway at constant sampling flow,
and analyze the samples by CO2 sensor built in the module.

Mainstream

For this measurement, CO2 sensors are installed on the airway adapter that plugs directly
into the patient's breathing system.

2. CO2 Measurement provides:

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 standards, CO2 concentration shall be monitored while the
equipment is connected with a patient. If your equipment does not have the function, please
use a monitor conforming to corresponding international standards for CO2 concentration
monitoring.

Caution

8-1
  To make sure the safety of patient, perform CO2 monitoring while use this equipment.. If
your equipment does not have the function of CO2 monitoring, please use an equipment
with CO2 monitoring function which conforms to corresponding international standards.

8.2 Identification of CO2 Modules

8.2.1 MASIMO CO2 Module(Sidestream)

2 5

1 Module working indicator 4 Sampling line port

2 CO2 setting menu button 5 Measure/Standby button

3 Gas outlet

8-2
8.2.2 MASIMO CO2 Module (Mainstream)

2 4

1 Module work indicator 3 12-pin data interface

2 CO2 Settings menu button 4 Measurement / standby button

8.2.3 Respironics CO2 Module (Sidestream)

2 5

8-3
 1 Module working indicator 4 Sampling line port

2 CO2 Settings menu button 5 Measurement / standby button

3 Gas outlet

8.2.4 Respironics CO2 Module (Mainstream)

2 4

1 Module working indicator 3 12-pin data interface

2 CO2 Settings menu button 4 Measurement / standby button

8.3 Nomoline Family sampling lines

Samples gas from the respiratory circuit through the Nomoline Family sampling line at a rate of 50
sml/min, making measurements of CO2 possible for adult, pediatric patients.

The Nomoline Family sampling lines incorporate a unique water separation (NO MOisture) section,
which removes condensed water. The NOMO section is also fitted with a bacteria filter that protects
the gas analyzer from water intrusion and cross contamination.

As long as no sampling line is connected, the CO2 module remains in a low-power sleep mode. Once
the sampling line is connected, the CO2 module switches to measuring mode and starts delivering gas
data.

The Nomoline Family sampling lines are available in a wide variety of versions for both intubated and
8-4
 spontaneously breathing patients and in both disposable and re-sposable configurations –intubated
patients can for instance be monitored using the disposable Nomoline Airway adapter Set or a
com-bination of the multiple patient use Nomoline Adapter and a disposable Nomoline Extension /
T-adapter. Spontaneously breathing patients could similarly be monitored using a disposable
Nomoline Nasal CO2 Cannula or a combination of the multiple patient use Nomoline Adapter and a
disposable Nomoline Nasal CO2 Cannula with Luer Connector.

Figure 1.The disposable Nomoline Airway Adapter Set is an alternative to using a combination of the
multiple patient use Nomoline Adapter and a disposable Nomoline Extension / T-adapter.

The Nomoline Adapter may be used with other third party sampling lines and cannulas. Please
however note that the Nomoline Family of sampling lines are designed for optimal performance and
measure-ment fidelity when used with the CO2 module. For instance, when connecting to a
respiratory circuit, the Masimo T-adapter provides a central gas sampling point thereby minimizing the
risk of sampling line occlusion (see below)

Figure 2. For optimal water handling, always use T-adapters with the sampling point in the center of
the adapter, as shown to the left above.

Note

 Using sample lines or cannulas with larger inner diameter than 1 mm will increase module’s
total system response time.

8-5
8.4 Measuring Procedure of MASIMO Sidestream, Mainstream
Modules

Caution

 The section is only applicable to Sidestream and Mainstream CO2 module of anesthesia
machines.

Warning

 MASIMO Sidestream CO2 module cannot be used in flammable anesthetic gases.

8.4.1 Measuring Procedures and Testing of Sidestream Module

 Measuring Procedures

Set the Sidestream CO2 module to perform gas analysis:

a) Install the module to the corresponding position of the anesthesia machine plug slot.

b) Connect one end of Nomoline sampling line to the input port of CO2 module, and the
other end of the sampling line to the patient.

c) Turn the system switch to the right side to start the anesthesia machine. The indicator
at the top left corner of the CO2 module is in green.

d) In [Config] menu, select [Gas Module]→set the options like

[Unit],[O2Compensation], [Balance gas], [Altitude].

e) Click [Zero Sensor]. While zeroing, the screen shows: In zero calibration, please wait
for 30s, and start to measure CO2 after the prompt is finished.

f) When CO2 monitoring function is turned on, its working mode is “measure” by
default. However, to ensure the set mode, access [CO2 module] and verify that its
[work mode] is set to [Measure] mode.

g) Connect the gas sample outlet to the scavenging system, or allow the gas to flow back
to the patient circuit.

h) Check the equipment as per “Chapter 4 Tests before Use”.

i) Testing result is normal, and start CO2 monitoring.

8-6
 Sampling tube
Sampling Line Sampling
SamplingLine
tube

Fig. 8-1 Connection Diagram

 Checks before Use

Before connect the Nomoline sampling line to patient respirotary circuit, perform the
following steps:

a) Connect the sampling line to the gas inlet port of CO2 module;

b) Verify that the green lamp of indicator lightis on;

c) Verify that the indicator at the top left corner of the CO2 module is in green..

d) Exhale to the sampling line, and verify that valid CO2 waveforms and values are
displayed on the anesthesia machine.

e) Block the sampling line mouth with fingertip for 10 seconds.

f) Check whether or not a clogging alarm is triggered and flashing red light is on gas inlet
port

g) If necessary, perform leak check of patient circuit that is connected to the sampling line.

Caution

 The end of airway adapter connecting to the sampling line shall point upwards to prevent
condensed water drops from entering the sampling line and resulting in clogging.

8.4.2 Measuring Procedures and Tesitng of Mainstream Module

1. Measuring Procedures
Set the mainstream CO2 module to perform gas analysis:
a) Install the mainstream module to the corresponding position of the anesthesia machine slot .
b) Plug the end of the 12Pin connector of the patch cord into the 12Pin data interface of the
mainstream CO2 module. Connect the other end to the MASIMO mainstream CO2 probe. Install the probe on
the airway adapter. Finally, connect the airway adapter to the patient‟s breathing circuit.

8-7
 c) Turn the system switch to the right side to start the anesthesia machine. The indicator at the top
left corner of the CO2 module is in green.
d) In the [Config] menu, select [Gas Module], and then set up options of [Unit], [O2Compensation],
[Balance gas], [Altitude], etc.
e) Click [Zero Sensor]. While zeroing, the screen shows: In zero calibration, please wait for 30s, and
start to measure CO2 after the prompt is finished.
f) When CO2 monitoring function is turned on, its working mode is [measure] by default. However,
to ensure the set mode, access [CO2 module] and verify that its [work mode] is set to [Measure]
mode.

g) Check the equipment as per “Chapter 4 “Tests before Use”.

h) Testing result is normal, and start CO2 monitoring.
2. Checks before Use
Before connect the adapter to patient respirotary circuit, perform the following steps:
a) Verify that the 12-pin adapter cable is connected to the 12-pin connector of mainstream CO2
module.
b) Verify that the working indicator at the top left corner of the mainstream plug-in is constantly in
green .
c) Verify that the probe indicator is in green steadily.
d) Expire to the adapter, and verify that valid CO2 waveforms and values are displayed on the
anesthesia machine.

Caution

 The end of the airway adapter connecting to the sampling line shall point upwards to
prevent the condensed water droplets from entering the sampling line and resulting in
clogging.

8.5 Measuring Procedures of Respironics Mainstream and

Sidestream Modules

8.5.1 Measuring Procedures and Testing of Sidestream Module

 Measuring Procedures
Set the sidestream CO2 module to perform gas analysis:
a) Install the sidestream module to the corresponding position on the anesthesia machine.

8-8
 b) Connect one end of Respironics sampling line to the sampling port of Respironics CO2 module, and
the other end to the patient end.
c) Turn the system switch to the right side to start the anesthesia machine. The indicator at the top left
corner of the CO2 module is in green.
d) In the [Config] menu, select [Gas Module], and then set up options of [Unit],
[O2Compensation], [N2O compensation], [Zero Sensor], etc.
e) Click [Zero Sensor]. While zeroing, the screen shows: In zero calibration, please wait for 30s, and
start to measure CO2 after the prompt is finished.
f) When CO2 monitoring function is turned on, its working mode is [measure] by default. However,
to ensure the set mode, access [CO2 module] and verify that its [work mode] is set to [Measure]
mode.

g) Connect the gas sample outlet to the exhaust system or allow the gas to flow back to the patient
circuit.
h) Check the equipment as described in “Chapter 4 “Tests before Use”.
I) Testing result is normal, start the CO2 monitoring.
 Checks before Use
Before connect Respironics sampling line to the patient's respiratory circuit, perform the the following
steps:
a) Connect the Respironics sampling line to the Respironics CO2 module gas inlet.
b) Verify that the working indicator at the top left corner of the mainstream module is constantly in
green (indicating that the plug-in module is powered on normally)
c) Expire to the adapter on the sampling line, and verify that valid CO2 waveforms and values are
displayed on the anesthesia machine.
d) Block the sampling line mouth for 10 second.
e) Check whether the clogging alarm is displayed on anesthesia machine.
f) If necessary, perform a leak test on the patient circuit connected to the sampling line.

8.5.2 Measuring Procedures and Testing of Mainstream Module

 Measuring procedures
Set the mainstream CO2 module to perform gas analysis:
a) Install the mainstream module to the corresponding position on the anesthesia machine.
b) Plug the end of the 12Pin connector of the patch cord into the 12Pin data interface of the
mainstream CO2 module. Connect the other end to the mainstream CO2 probe. Install the probe on the airway
adapter. Finally, connect the airway adapter to the patient‟s breathing circuit..
c) Turn the system switch to the right side to start the anesthesia machine. The indicator at the top left
corner of the CO2 module is in green.
8-9
 d) In the [Config] menu, select [Gas Module], and then set up options of [Unit],
[O2Compensation], [N2O compensation], [Zero Sensor], etc.
e) Click [Zero Sensor]. While zeroing, the screen shows: In zero calibration, please wait for 30s, and
start to measure CO2 after the prompt is finished.
f) When CO2 monitoring function is turned on, its working mode is [measure] by default. However,
to ensure the set mode, access [CO2 module] and verify that its [work mode] is set to [Measure] mode.
g) Check the equipment as described in Chapter 4 “Tests before Use”.
h) Testing result is normal, start the CO2 monitoring.
 Checks before Use
Before connect the adapter to the patient's respiratory circuit, perform the the following steps:
a) Verify that the 12-pin adapter cable is connected to the 12-pin connector of the mainstream CO2
module
b) Verify that the working indicator at the top left corner of the mainstream module is constantly in
green .
c) Expire to the adapter and verify that valid CO2 waveforms and values are displayed on the
anesthesia machine.

Note

 The end of the gas adapter connecting to the gas sampling line shall point upwards to
prevent the condensed water drops from entering the gas sampling line and resulting in
clogging.

8.6 Set the CO2

On the screen, select [Config] menu → [Gas Module] or press the CO2 setting button on the module to enter
[Gas Module], and you can set the CO2 parameters.

8-10
 Fig. 8-2 Set the Configuration of Carbon Dioxide

8.6.1 Set the Work Mode

Work Mode: standby, measure

Standby:

When CO2 module remains in its standby mode, the gas pump stops so as to extend the lifespan of module; in
addition, a prompt “CO2 Module Standby” is displayed in the message area.

Measure:

When CO2 module is working, the indicator of CO2 module is constantly in green, and measured data is sent
to the anesthesia machine simultaneously.

In normal condition, when CO2 module is connected to the anesthesia machine, the module automatically set
the operating mode to “Measure”. However, the user must verify that the CO2 module is set to measuring
mode.

When the anesthesia machine is used for the first time, the [Work Mode] in CO2 monitoring is set to
[Measure] by default . If CO2 monitoring is in standby mode, you can start CO2 monitoring by selecting
[Config] menu → [Gas Module] → [CO2 Module]→ [Work Mode] , and set it to: [Measure], or by
pressing the Measure/Standby button on the module to switch between the Standby/Measure mode.

8-11
Note

 During sensor calibration, press the Measure/Standby button cannot switch the operating
mode. At this time, the Measure/Standby button on the screen does not function either.

 When anesthesia machine is restarted, all the setting of CO2 module before the last
shutdown will be reserved.

8.6.2 Set the Units

On the screen, select [Config] menu → [Gas Module] → [CO2 Module] → [CO2Unit] , and set it to:
[mmHg] , [%] or [kPa] .

8.6.3 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 Select [Gas Module].

3 Set the gas compensation concentration of [CO2 module] in accordance with actual
conditions:

 [O2 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%. When an O2 module is equipped, an O2 sensor automatically
performs O2 compensation according to the O2 concentration. Therefore, this option is
in the default state. When no O2 sensor provides automatic O2 compensation, the
compensation level can be manually set according to the actual O2 concentration (as
shown in the table below).

O2 Range Parameter of
SetO2

0-30vol% 21

30-70vol% 50

70-100vol% 85

8-12
  [N2O Compensation]

N2O compensation can be set to ON or OFF. If the CO2 module can measure N2O,
it can automatically perform N2O compensation based on the N2O concentration;
therefore, the selection is by default. If the CO2 module cannot measure N2O, the
compensation level can be set manually per actual N2O concentration(as shown in the table
below).

N2O Range Parameter of

SetN2O

0-30vol% 0

30-70vol% 50

8.6.3.1 Displaying CO2 Waveform

1. On the screen , access the [Config] menu.

2. Open the [Screen] menu.

3. Set the [CO2 Wave] to [ON].

4. Plug in CO 2 module the main screen to view the CO2 waveform. The CO2 waveform is
shown as the figure below.

Fig. 8-3 CO2 waveform

8.7 Exhaust gas emission

Connect the exhaust tube to the gas outlet on the module, so as to discharge the sample gas into the
scavenging system.

Exhaust tube

8-13
 Warning

 Emitted gas shall be re-entered into the patient circuit or discharged into the discharge
system.

 If the collected gas sample is to be supplied for breathing, always use a bacterial filter on
the exhaust side.

 If the suction pressure is too high during discharge, the sample flow rate may be affected.

 If the positive or negative pressure in the patient circuit is too large, the sample flow rate
may be affected.

 Check whether the gas sample flow rate is too high for the given patient category.

8.8 Maintaining and Cleaning MASIMO Mainstream/Sidestream

CO2 Module

8.8.1 Zeroing
For sidestream CO2 module, 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

Sidestream CO2 module can automatically perform zeroing by switching the gas sampling
from respiration circuit to ambient air. Sidestream CO2 module spends less than 3 seconds
to perform automatic zeroing once, and the frequency is 1time every day.

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.

Warning

 Since successful zeroing requires ambient air (21% O2 and 0% CO2) in the sidestream CO2
module, be sure to place the CO2 module in a well ventilated location. Avoid breathing near

8-14
 the sidestream CO2 module before and after performing the zeroing procedure.

8.8.2 Failure Handling

When the sampling system of CO2 module gets abnormal, check whether or not the sampling lines are
entangled together. Once the indicator at gas inlet port flashes red, or Nomoline clogging message is
displayed on the anesthesia machine, replace the sampling line.

8.8.3 Calibration

CO2 module does not require routine calibration. However, it shall be calibrated every other year or when the
deviation of measured values gets too high.

8.8.4 Analyzer cleaning

The “plug-in and measure” CO2 module and Nomoline Adapter can be cleaned using a cloth
moistened (not wet) with max 75% medicinal alcohol.

To prevent cleaning liquids and dust from entering the sidestream CO2 module through its
connector, keep the Nomoline Family sampling line connected while cleaning the sidestream CO2
module.

Warning

 Nomoline adsorption tube is not a sterile device. In order to avoid damage, do not perform
high-pressure sterilization on any part of the adsorption tube.

 Never sterilize or immerse the Sidestream CO2 module in liquid.

8.8.5 Lighting signals of the CO2 module

A brief introduction of the LEGI indications:

Indication Status
Steady green light System OK
Blinking green light Zeroing in progress
Steady red light Sensor error
Blinking red light Check sampling line

8-15
8.8.6 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 CO2 module.

It can be converted to other units using the actual atmospheric pressure sent from the CO2 module.

Carbon dioxide (mmHg)=(carbon dioxide concentration)x(atmospheric pressure from CO2 module

(kPa))x (750 / 100)

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
anesthetic gases depend on the water vapor content of the gas detected. Oxygen detection will be
calibrated. 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
anesthetic 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 sidestream CO2 module. No water can get into

8-16
 CO2 module 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 CO2 module

Pamb = atmospheric pressure [kPa] from CO2 module

3.8 = Typical partial pressure [kPa] of the water vapor condensed between patient‟s respiration
circuit and CO2 module

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.

8.8.7 Warnings

Warning

 The sidestream CO2 module is intended for use by authorized healthcare professionals only.
 Carefully route the sampling line to reduce the risk of patient entanglement or strangulation.
 Do not lift the CO2 module by the sampling line as it could disconnect from the CO2 module,
causing the CO2 module to fall on the patient.
 Dispose Nomoline Family sampling lines in accordance with local regulations for biohazardous
waste.
 Use only airway T-adapters with the sampling point in the center of the adapter.
 Do not use T-adapter with pediatrics, as this adds 7 ml dead space to the patient circuit.
 Do not use the CO2 module with metered-dose inhalers or nebulized medications as this may clog
the bacteria filter.
 Since a successful zeroing requires the presence of ambient air (21% O2 and 0% CO2), ensure
that the CO2 module is placed in a well ventilated place. Avoid breathing near the sidestream
CO2 module before or during the zeroing procedure.
 Never sterilize or immerse the sidestream CO2 module in liquid.
 The sidestream CO2 moduleis intended only as an adjunct in patient assessment. It must be used

8-17
 in conjunction with other assessments of clinical signs and symptoms.
 Measurements can be affected by mobile and portable RF communications equipment. Make
sure that the sidestream CO2 module is used in the electromagnetic environment specified in this
manual.
 Replace the sampling line if the sampling line input connector starts flashing red, or the medical
backboard device displays a “Check sampling line” message.
 No modification of this equipment is allowed without authorization of the manufacturer. If this
equipment is modified, appropriate inspection and testing must be conducted to ensure continued
safe operation.
 The sidestream CO2 module are not designed for MRI environments.
 During MRI scanning, CO2 module must be placed outside the MRI suite.
 Use of high frequency electrosurgical equipment in the vicinity of the CO2 module/medical
backboard device may produce interference and cause incorrect measurements.
 Do not apply negative pressure to remove condensed water from the Nomoline Family sampling
line.
 Too strong positive or negative pressure in the patient circuit might affect the sample flow.
 Strong scavenging suction pressure might affect the sample flow.
 Exhaust gases should be returned to the patient circuit or to a scavenging system.
 Due to the risk of patient cross-infection, always use a bacteria filter on the exhaust port side if
sampled gas is intended to be re-breathed.
 Do not place the CO2 module gas analyzer in any position that might cause it to fall on the
patient.
 Do not re-use disposable single-patient use Nomoline Family sampling lines due to the risk of
cross contamination.
 Do not sterilize or immerse Nomoline Family sampling lines in liquid.
 Do not operate the sidestream CO2 module if the enclosure is damaged.
 Do not use the Nomoline Airway Adapter Set pediatric with pediatric patients.

8.8.8 Sampling line clogged

If the anesthetic gas passage is clogged, an [Sampling line clogged] message will be displayed
on the screen. In this case, replace the sampling line.

Warning

8-18
 The CO2 module should be securely mounted in order to avoid the risk of damage to the CO2
module.
 Do not operate the sidestream CO2 module outside the specified operating environment.
 Federal law restricts this device to sale by or on the order of a physician.
 For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, precautions and adverse events.
 Do not use sidestream CO2 modules with metered-dose sprays or atomization treatments.
Otherwise, the bacteria filters may be clogged.

8.8.9 Consumables
The Nomoline Adapter is a multiple-patient use product.

The Nomoline 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 together with a message on the medical backboard device.

8.8.10 Maintenance
The user shall check the gas readings regularly, and contact the manufacturer engineers for
maintenance if any anomaly is detected.

8.9 Maintaining and Cleaning Respironics Mainstream/Sidestream

CO2 Module

8.9.1 General Cleaning

Dip a cloth in 75% medicinal alcohol, water solution (bleach) containing 10% sodium
hypochlorite, disinfecting spray cleaner (like Steris Coverage SprayHB), ammonia water or mild
soapy water, wash it with water, wring it and then use it to clean the sensor. Dry it and make sure
its sight glass is clean before using the cleaned sensor.

8.9.2 Clean the Reusable Airway Adapter of Mainstream Sensor

Wash the airway adapter with mild soapy water, dip it in the disinfectant, like 75% medicinal
alcohol, water solution (bleach) containing 10% sodium hypochlorite, 2.4% glutaraldehyde solvent
(Cidex Plus, Steris System 1, etc.) or ammonia water, and then rinse it with sterile water and dry it.

8.9.3 Disinfection of Reusable Airway Adapter

Autoclave: applicable to the airway adapter for adults only.
8-19
 ETO: disinfect the airway adapter for 1.5h.

Dip in Cidex Plus solvent for 10h.

Dip in Perasafe solvent for 10h.

U.S. Steris System 1 low-temperature sterilization cabinet.

Make sure it is not damaged in operations or in the cleaning/disinfection process and its sight glass
is dry without any residue before using the disinfected airway adapter.

8.9.4 Disinfection Frequency of Reusable Airway Adapter

The above disinfection methods allow you to reuse the airway adapter for 100 times.

8.9.5 Zeroing
Please zero before using CO2，The purpose is to eliminate the impact of baseline drift occurring
during measuring, and guarantee the correctness of measurements.

Usually, the CO2 sensor will be auto zeroed when necessary. You can zero it manually when you
consider it necessary: access [Config] menu, open the [Gas Module] menu, and select [Zero Sensor]
in [CO2Module] to zero the CO2 sensor. Keep the patient circuit in the ambient air (21% O2 and 0%
CO2) for 30s in the zeroing process,when the zero prompt for 30s of the interface is finished,it
means that the zero is completed.

8-20
 Chapter9 Monitoring AG (Anesthetic Gas)

9.1 Overview
Anesthetic Gas (AG) can be used to measure the Anesthetic Gas and Respiratory Gas of the patient

under anesthetization. The Anesthetic Gas module provides the numerical values at the end of

expiration (Et) and the inspiration (Fi) of the following gases.

AG monitoring provides:
EtCO2 waveform
Monitored Parameters: FiO2, EtO2, EtCO2, FiCO2, EtN2O, FiN2O, EtAA, FiAA and MAC

AA stands for one of the Anesthetic Gases among Des (Desflurane), Iso (Isoflurane), Enf (Enflurane),

Sev (Sevoflurane) and Hal (Hhalothane).

Warning

 As required by international regulations, when this device is applied to a patient, AG

concentration monitoring is required. If the device you are using is not equipped with this
function, monitor the AG concentration using a monitor that complies with relevant
international standards.

Attention

 In accordance with international standard (ISO 80601-2-55), AG shall be monitored while the

equipment is connected with a patient. If your equipment does not have the function, please use a

monitor conforming to corresponding international standards for AG monitoring.

 Only use anesthetic gases specified by our company.

9.2 Measurement Principle of Anesthetic Gas

The Anesthetic 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
9-1
 and a prism or a diffraction grating to separate the wave length of each kind of anesthetic. 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 inhalational anesthetic 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 Anesthetic Gases. The MAC value stands for the density of Anesthetic 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.

9-2
 % Et ( AA1) % Et ( AA2) % Et ( N 2O)
MAC    ... 
Xage ( AA1) Xage ( AA2) Xage ( N 2O)
1MAC：X ( AA) : HAL  0.75%, ENF  1.7%, ISO  1.15%, SEV  2.05%, DES  6.0%, N2O  100%
1MAC  age  corrected  for , Xage ( AA) : Xage ( AA)  X ( AA) *10 (-0.00269*(age-40))

For example, when using one or several anesthetics, the anesthesia module measures and get that a

60-year-old 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

4% 0.5% 50%
MAC  -0.00269*20
 -0.00269*20
  2.08
6% *10 0.75% *10 100% *10-0.00269*20

Attention

 The above formula is only applicable to patients over 1 year old, 1 year old or below is calculated

as 1 year old.

 The above formula does not take the altitude, 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 main advantages of the Paramagnetic Oxygen Sensors include:

• short rise time

• stability and precision

• No need to change or supply chemicals

9-3
 • Generally dispense with maintenance

9.5 Calculating the Rate and Dosage of Anesthetic

When the AG module is configured, Anesthesia Machine can calculate the rate and dosage of anesthetic
agents.Anesthetic dosage is displayed on the standby screen.When the anesthesia machine is out of standby
mode,the anesthetic dosage accumulates from 0 and the rate of anesthetic use is calculated. When the
anesthesia machine go into the standby mode, anesthetic dosage stopped accumulating.

9-4
9.6 Identifying the AG Module

9.6.1 MASIMO AG Module (Sidestream)

2 5

Fig. 9-1 Sidestream AG Module

1 Working indicator 4 Sampling line connector

2 AG setting menu button 5 Measure/Standby button

3 Gas outlet

Note

 The AG Module has been equipped with automatic atmospheric pressure compensation.

9-5
9.6.2 MASIMO AG+O2 Module (Sidestream)

2 5

Fig. 9-2 MASIMO AG+O2 monitoring(sidestream)

1 Module working indicator 4 AG/O2 universal module connector

2 AG setup menu 5 Measurement / standby button

3 Gas outlet

9.6.3 ARTEMA AG Module (Sidestream)

2 5

3
6

9-6
 Fig. 9-3 ARTEMA AG Monitoring(Sidestream)

1 Module working indicator 4 Sampling line connector

2 AG setup menu 5 Measurement / standby button

3 Gas outlet 6 Watertrap

9.6.4 ARTEMA AG+O2 Module (Sidestream)

1
12 5

3
6
3
5

Fig. 9-4 ARTEMA AG+O2 Monitoring(Sidestream)

1 Module working indicator 4 Sampling line connector

2 AG setup menu 5 Measurement / standby button

3 Gas outlet 6 Watertrap

9-7
 Attention

 The watertrap is used to collect condensing water droplets from the sampling gas to prevent
them from entering the module.When the water collected in the watertrap reaches a certain
amount,the water must be poured out before it can be used again,so as to avoid blocking the
airway.

 The watertrap contains filtering material to prevent bacteria/water vapor and patient secretions
from entering the module.When used for a long time,dust or other foreign matter will reduce
the air permeability of the filter material in the watertrap,and in serious cases,the air passage
will be blocked,At this time,the watertrap must be replaced.It is recommended to replace the
watertrap once a month or when a leak/damage or serious contamination is found.

9.7 AG module Measurement preparation

9.7.1 MASIMO AG Module(Sidestream)

 Measuring Procedures

Set the anesthesia machine to start gas analysis:

a) Install the sidestream AG module to the corresponding position on the anesthesia machine.

b) Connect the Nomoline sampling line to the gas inlet of the AG module.

c) Turn the system switch to the right side to start the anesthesia machine. The indicator at the
top left corner of the AG module is in green.

d) In the [Config] Menu→ select [Gas Module] → [AG Module]→set the items, such as
[Unit] , [O2 Compensation] , [Zero Sensor].

e) When the AG module is turned on, the working mode of the module is [Measure]. 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 scavenging system, or to make the gas to flow
back to the patient‟s circuit.

g) If it is green LED indication, Analyzer is available.

h) To carry out inspection before use according to the statement in the “Chapter 4 Test before

9-8
 Use”.

i) If the inspection is normal, start to monitor the Anesthetic Gas.

Sampling Sampling
line line

Fig. 9-5 The sketch map of preliminary work and connection

 Check before use

Before connecting the Nomoline sampling line to the breathing circuit, carry out the following
steps:

a) Connect the sampling line to the interface of gas inlet of the Anesthesia Module.

b) Check whether the green light of AG Module is steadily on or not(The indication Module is
normal.).

c) Check whether the connection port of the luminescent sample tube is steadily on or not(The
indication system is normal.).

d)

e) Breathe out air to the sampling pipe, and check whether the anesthesia machine shows the
effective wave pattern and values of CO2.

f) Use the finger tip to block up the sampling line, and hold on for 10s.

g) Examine whether there is obstruction warning and if the luminescent sample tube shows a red
flashing light.

h) Under proper circumstances:Carry out enclosure check on the patient‟s circuit that is linked
with the sampling line.

9.7.2 MASIMO AG+O2 Module(Sidestream)

 Measuring Procedures
9-9
 Set the anesthesia machine to start gas analysis:

a) Install the sidestream AG module to the corresponding position on the anesthesia machine.

b) Connect the Nomoline sampling line to the gas inlet of the AG module.

c) Turn the system switch to the right side to start the anesthesia machine. The indicator at the
top left corner of the AG module is in green.

d) If there is oxygen sensor, enter the maintenance mode, and choose [Config]→[System Config]
→[O2 OPTION]→ [ON] .

e) Click [Zero Sensor]. While zeroing, the screen shows: In zero calibration, please wait for 30s,
and start to measure CO2 after the prompt is finished.

f) In the [Config] Menu→ select [Gas Module] → [AG Module]→set the items, such as
[Unit] , [O2 Compensation] , [Zero Sensor].

g) When the AG module is turned on, the working mode of the module is “Measure”. 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.

h) To connect the outlet of the sample gas to the scavenging system, or to make the gas to flow
back to the patient‟s circuit.

i) If it is green LED indication, Analyzer is available.

j) To carry out inspection before use according to the statement in the “Chapter 4 “Tests before
Use”.

k) If the inspection is normal, start to monitor the Anesthetic Gas.

Sampling Sampling
line line

Fig. 9-6 The sketch map of preliminary work and connection

 Check before use

Before connecting the Nomoline sampling line to the breathing circuit, carry out the following

9-10
 steps:

a) Connect the sampling line to the interface of gas inlet of the Anesthesia Module.

b) Check whether the green light of AG Module is steadily on or not(The indication Module is
normal.).

c) Check whether the connection port of the luminescent sample tube is steadily on or not(The
indication system is normal.).

d) As for the Anesthesia Module furnished with oxygen option:Check whether the oxygen
reading on the host equipment is correct or not(21%).

e) Breathe out air to the sampling pipe, and check whether the anesthesia machine shows the
effective wave pattern and values of CO2.

f) Use the finger tip to block up the sampling line, and hold on for 10s.

g) Examine whether there is obstruction warning and if the luminescent sample tube shows a red
flashing light.

h) Under proper circumstances:Carry out enclosure check on the patient‟s circuit that is linked
with the sampling line.

9.7.3 ARTEMA AG Module(Sidestream)

 Measuring Procedures

Set the anesthesia machine to start gas analysis:

a) Install the sidestream AG module to the corresponding position on the anesthesia machine.

b) Select the appropriate Watertrap according to the patient type and push the watertrap firmly
into the watertrap socket.

c) Turn the system switch to the right side to start the anesthesia machine. The indicator at the
top left corner of the AG module is in green.

d) In the [Config] Menu→ select [Gas Module] → [AG Module]→set the items, such as
[Unit] , [O2 Compensation] , [Zero Sensor].

e) When the AG module is turned on, the working mode of the module is “Measure”. 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 scavenging system, or to make the gas to flow
9-11
 back to the patient‟s circuit.

g) Connect one end of the sample tube to the sink and the other end to the patient‟s circuit.

h) To carry out inspection before use according to the statement in the “Chapter 4 “Tests before
Use”.

i) If the inspection is normal, start to monitor the Anesthetic Gas.

Warning

 Children can not use the adult sink,or may cause damage to the patient.

 The sink is used to collect condensing water drops in the sample tube to prevent water drops
from entering the module.When the water collected by the sink reaches a certain amount,the
water must be discharged before it can continue to be used,so as to avoid blocking the the gas
path.

 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.

9.7.4 ARTEMA AG+O2 Module(Sidestream)

Please refer to 9.6.3 ARTEMA AG Module(Sidestream)

9.8 Setting AG
Set the following items on the screen 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
the AG parameters.

9-12
 Fig. 9-7 AG Module Configuration

9.8.1 Setting 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 on the screen 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.

9-13
Note
 During calibration of the sensor, press the Measure/Standby button cannot switch the
operating mode. At this time, the Measure/Standby button on the screen does not function
either.
 When anesthesia machine is restarted, all the setting of AG module before the last
shutdown will be reserved.

9.8.2 Set the Units

On the screen, select [Config] menu →[Gas Module]→[AG Module]→[CO2 Unit] , and set it to:
[mmHg] , [%] or [kPa] .

9.8.3 Setting Gas 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% .When an O2 module is equipped, an
O2 sensor automatically performs O2 compensation according to the O2 concentration. Therefore,
this option is in the default state. When no O2 sensor provides automatic O2 compensation, the
compensation level can be manually set according to the actual O2 concentration (as shown in the
table below).

Oxygen concentration（%） Compensation level

0~30 High（21%）

30~70 Middle（50%）

70~100 Low（85%）

9.8.4 Zeroing

The infrared gas analyzer needs to establish a zero reference level for the CO2, N2O and

9-14
 anesthetic agent gas measurement. This zero calibration is here referred to as "zeroing".

1. Automatic zeroing

AG module performs automatic zeroing by switching the gas samples from the breathing
circuit to the environmental atmosphere. The automatic zeroing is performed every 24 hours
and takes less than 10 seconds. If the AG module is equipped with an oxygen sensor,
automatic zeroing shall include calibration of air within the oxygen sensor

2. Manual zeroing

The AG module 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 module is placed in a well ventilated place. Avoid breathing near the AG module before
or during the zeroing procedure.

9.8.5 Displaying 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. Plug in AG module,CO2 waveform may be viewed once you return to the [waveform]
window of user interface(If it is Artema AG,the waveform will not be displayed until the
warm-up is over and the waveform is in the working state). As shown in the figure below.

Fig. 9-8 CO2 waveform

9.9 Anesthetic replacement

If the anesthetic in use is changed, the module can still detect the mixture of two gases during the

9-15
 transient phase. But the time needed for anesthetic replacement is decided by the type (low-flow or
high-flow) and character (pharmacokinetics) of the anesthetic. No reminding notice will be given by
the anesthesia apparatus for anesthetic replacement; and the MAC values displayed might be
incorrect during replacement.

ISA analyzer can recognize the anesthetics automatically. When the content of one anesthetic is
under the limit, while another anesthetic accounts for a major part, the anesthesia apparatus can
detect this change, and indicate the name and data of the an anesthetic.

9.10 Lighting signals of MASIMO AG module

A brief introduction of the indications:
Indication Status
Steady green light System OK
Blinking green light Zeroing in progress

Steady blue light2) There is an anesthetic gas

Steady red light Sensor error

Blinking red light Check sampling line

9.11 Adverse impact on performance

Please refer to content with corresponding of this section of " 8.8.6Adverse impact on performance"
part.

9.12 Warnings
Please refer to content with corresponding of this section of " 8.8.7Warnings" part.

9.13 Sampling line clogged

Please refer to content with corresponding of this section of "8.8.8 Sampling line clogged " part.

9.14 Exhaust gas emission

Please refer to content with corresponding of this section of " 8.7 Exhaust gas emission " part.

9-16
9.15 Consumables
Please refer to content with corresponding of this section of " 8.8.9Consumables " part.

9.16 Maintenance
Please refer to content with corresponding of this section of " 8.8.10 Maintenance " part.

9-17
 Chapter10 Monitoring BIS

Warning

 The conductive parts of the sensor and interface shall not be in contact with other conductive
parts, including the ground contact.

 In high-frequency surgery, to avoid the risk of burns, the BIS sensor shall not be placed between
the surgical site and the electrosurgical device return electrode.

 When using a defibrillator on a patient, BIS sensors shall not be placed between the defibrillator
pads.

 BIS serves only as an adjunct to clinical diagnosis and training.

 Clinical efficacy, risk / benefit and application of BIS function have not been fully validated in
pediatric patients.

 To reduce the risk of burns during use of the brain stimulation device (e.g. cranial stimulation of
motor-induced potentials), place the stimulation electrodes as far away from the BIS sensor as
possible and ensure that the sensor is placed as indicated in the instructions on the package.

 BIS monitoring anti-defibrillation recovery time is less than 30s.

10.1 General Introduction

BIS monitors the electroencephalogram (EEG) signals of the cerebral cortex, and combines the
frequency and power spectrum analysis methods to give a quantitative dual-frequency index. Meanwhile, by
combining with the quality analysis of the EEG signals, BIS comprehensively evaluates the patient's current
state of consciousness and thus identifies the dual-frequency index.
The system supports 4 measuring parameters of BIS, EMG, SR, and SQI. It provides a waveform that
displays a BIS module's continuous detection of EEG signals, which is referred to as the BIS EEG waveform,
and provides a dynamic trend of displaying BIS, which is referred to as the BIS Trend.

10.2 BIS module

Dual-frequency index monitoring is only possible when the anesthesia machine is equipped with BIS
modules.

10-1
 1

2 4

Fig. 10-1 BIS Module

1 Module working indicator 3 BIS module cable connector

2 BIS setup menu 4 Measurement / standby button

10.3 BIS display

BIS waveform area provides display modes: BIS EEG waveform.

Fig. 10-2 BIS EEG Waveform

Parameter English name Meaning Unit Range

Reflecting the level of

BIS Bispectral Index / 0-100
consciousness of the patient

10-2
 Reflecting the electric
EMG Electromyogram activity of muscle activity dB 0-100
and high frequency artifacts.
SR is the percentage of time
the EEG is considered
SR EEG suppression ratio % 0-100
inhibited in the last 60
seconds of the session.
The SQI value reflects the
quality of the signal and
SQI Signal quality index provides the reliability of the % 0-100
BIS, SR values during the
last minute.
BIS
Numeric BIS Numeric Update Once per
frequency range /
Update Frequency second
Frequency
0.25 Hz
to 100
EEG
bandwidth EEG Bandwidth Hz Hz (-3
Bandwidth
dB) +/-
10%
When "impedance check in progress”, “the electrode impedance too high”, “poor signal quality”, or
“replacing the sensor” occurs, the measured values of the above four parameters will be affected.

BIS Clinical status

100 In a waking state

70 In a calm state, mild hypnosis, with low possibility of being

awakened

60 In general anesthesia, moderate hypnosis state

40 In a loss of consciousness, deep hypnosis state

0 In deep anesthesia state, where the EEG waveform is straight and

the patient has no EEG activity

EMG：

EMG﹤55dB; acceptable EMG.

10-3
 EMG≤30dB: Optimal EMG.
SQI:

0% ~ 15%, the value cannot be derived .

15% ~ 50%, the value cannot be reliably derived .
50%～100% , the value cant be reliably derived.

10.4 Safety Information

Due to limited clinical experience, the BIS values coming from patients with neurological abnormalities,
psychoactive patients, and pediatric under one year old should be carefully interpreted.

Warning
 The BIS shall not be taken as the only reference to adjust the anesthesia dose.

 The conductive parts of the sensor shall not be in contact with other conductive parts,

including the ground contact.

 In high-frequency surgery, to reduce the risk of burns, the BIS module shall not be placed

between the surgical site and the electrosurgical device return electrode.

 When using a defibrillator on a patient, BIS sensors shall not be placed between the

defibrillator electrode pads.

10.5 BIS Connection

1) The BIS module of this anesthesia machine uses a cable to receive the signal, first connect the BIS

module to the anesthesia machine.

2) Fix the module in place on the patient through the clip on the back of the BIS module, which shall

not be beyond the patient's head.

3) Connect the patient cable to the BIS module.

4) Attach the BIS sensor to the designated location on the patient as instructed by the sensor.

5) Connect the BIS sensor to the patient cable. Once the device detects a valid sensor, the impedance

of all electrodes will be automatically measured and the result will be displayed in the electrode

impedance test results window.

As shown in the following figure:

10-4
 BIS plug-in module

Fig. 10-3 BIS Connection Diagram

Electrode placement
No. of electrode
Position of Electrode Placement in English
pad

1 Center of the forehead

3 On temple

4 Directly above eyebrow

Warning
 It is of great importance that you place the electrode in the correct position to maintain proper

operation of the BIS.

 The electrode can be placed on the left or right side of the scalp.

 Do not place the BIS module over the patient's head so as o avoid any danger to the patient.

 Pleasure make sure the patient's skin is dry. Wet sensors or salt bridges may cause false BIS

and impedance values.

10.6 Electrode impedance test results window

Select [Config] - [BIS], and select [Impedance Test Results] (equivalent to manually conduct the electrode
impedance check) to enter this window, as shown below:

10-5
 Impedance
value (KΩ)

Fig. 10-4 Electrode Impedance Test Results Window

Click to [Impedance Test Results] to update the electrode impedance test results.The measured status
and impedance values are displayed in the electrode impedance test results window:
Symbol Status Measures to Be Taken

Electrode impedance test passed No action required

Check the cable, electrode and

skin contact status of the patient, if
Electrode impedance test failed
necessary, please clean and dry the
skin.

Electrode impedance test in progress No action required

BIS sensor not connected No action required

10.7 Setting BIS

10.7.1 Set BIS smoothness

Smoothness determines how anesthesia machines averages the BIS data. The smaller the value is, the
anesthesia machine responds more sensitively to changes in patient state. The larger the value is, the more
smooth the BIS trend is, with less variation and less artifact interference.
1) Select [Config] →[BIS Module]→ [BIS smooth rate].
2) Select [10s], [15s] or [30s].

10.7.2 Sensor replacement confirmation

1) When the instrument is in the process of testing, a technical alarm [Replacing the sensor] appears,

10-6
 replace the sensor.
2) Select [Config] →[BIS Module]→ [Confirm sensor replacement], suggesting that [Already
replaced]," select [Yes].

10.7.3 Set filter switch

1) Select [Config] →[BIS Module]→ [filter switch].

2) Select [ON] or [OFF].

10.7.4 Set wave shift

1) Select [Config] →[BIS Module]→ [wave shift].

2) Select 50uV,100uV,200uV,400uV,500uV,625uV,1000uV or 2000uV.

10.7.5 Set wave speed

1) Select [Config] →[BIS Module]→ [wave speed].

2) Select 6.25mm/s,12.5mm/s,25mm/s or 50mm/s.

Note

 When anesthesia machine is restarted, all the setting of BIS module before the last shutdown
will be reserved.

10-7
 Chapter11 Trend and Logs

11.1 Trend Table

Trend Table is used to review the data of physiological parameters of patients of corresponding
time point, and describes the changes in parameter measuring results. Trend provides VTexp,
VTinsp, MV, Ppeak, Pplat, Pmean, PEEP, Rate, FiO2, BIS and EtCO2, and it stores the data for
review for continuous 60 hours. The Trend Table refreshes when the machine is restarted.

On the screen, select [Trend] → [Table] to open the window shown in the figure below:

Fig. 11-1 Trend Table

1. Select [Res.], and select [1min], [2min], [4min], [5s] or [30s] as required.

2. You can view the Trend Table by one of the follow ways:

 Select [ ] and [ ] buttons of parameter to move the Trend Table leftwards or

rightwards and view the data of other parameters.

 Select [ ] or [ ] buttons of time to turn the pages of Trend Table upwards or

downwards and view more data.

11-1
11.2 Trend Graph
Graph is used to review the trend of parameter values over the time. The measured physiological
values corresponding to the time point are drawn into a curve which illustrates the patient
parameter‟s trend. Trend graph provides data review for VTe, VTi, MV, Rate, Ppeak, FiO2, EtCO2,
Plat, PEEP, Pmean,BIS, etc. for continuous 60 operating hours at the resolution of 5s. The trend
graph refreshes when the machine is restarted.

Select [Trend] → [Graph] to open the window shown in the figure below:

Attention
 After the anesthesia system is powered down or restarted after shutdown, the trend graph
will be cleared.

D
A

G H K

Fig. 11-2

A. Ordinate B. Abscissa C. Cursor Time

D. Cursor Parameter Display E. Parameter Name of Trend Curve F. Trend Curve

G. Time H. Cursor K. Parameter of the

L. Resolution trend curve

11-2
  Select Parameter for review: Select [Trend] → [Graph] → [Param], and click the [Param] button
to the desired parameter. The parameters are VTe, MV, Ppeak, FiO2 and EtCO2 etc.
 View Trend Curve: Select [Trend] → [Graph] → [Time], and click the [Time] button to move the
trend curve at an interval of a whole page.
 Move Cursor: Select [Trend] → [Graph] → [Cursor], and click [Cursor] button to move the
cursor at an interval of 5s. The time and parameter values corresponding to the cursor place are
displayed at right side of the trend graph,. The time and parameter values change as the cursor moves.
You can change the time interval of the cursor by selecting [Trend] → [Graph] → [Resolution]. The
range is 5s- 4min.

11.3 Alarm Log

Alarm log can save up to 2000 messages. Log messages are stored chronologically. The earliest
event will be overwritten if a new event takes place after 2000 messages has been stored. Alarm
log storage includes both technical alarm logs, physiologic alarm logs,indicate logs and setting
logs.

On the screen, select [Log] to open a window as shown in the figure below:

Fig. 11-3 Log Review

Alarm log can store all physiologic alarms, technical alarms, and setting information. The logging
is timer-sequenced, and the latest event appears foremost.

11-3
 In the menu, you can perform the following operations:

1. Select [Pre page] or [Next page] to view the alarm log one by one.

2. Select [Clear] to delete all logs.

3. Select menu “ ” and select the arrow button to choose the desired log filter. You
can select [All]( Display All), [Tech](Technical alarm), [Phys](Physiologic Alarm),
[Indicate], [Alarm record] or [Setting].

Caution
 When the anesthesia machine is completely powered off or turned off, the stored alarm log
are not deleted, and the log contents remain,but the shutdown time will not be saved in
log.

 If auditory alarms do not generate any longer, you can access the alarm log to view the
events that trigger alarms.

11-4
 Chapter12 Maintenance, Cleaning and Disinfection

Warning
 Observe the applicable regulations for safety protection.

 Carefully read the safety instructions of each cleaning agent to understand the applicable
materials.
 Read carefully the instructions for operation and maintenance of all sterilization equipment.

 Wear safety gloves and spectacles. Damaged oxygen sensor may cause leakage 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 surgical operation.
 Every time the equipment is disassembled, cleaned, disinfected or reassembled, the
operations described in the chapter “Tests Before Use” 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.

 For the maintenance, cleaning, disinfection of the external vacuum suction system, please
refer to the User Manual of vacuum suction system.

Caution

 Prior to initial use, the equipment shall be cleaned and disinfected 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.

12-1
  Please don’t use any abrasive cleaning agents (for example steel wool, silver polishing
materials or cleaning agents).

 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 marked with 134ºC allow sterilization by high-temperature vapor.

 PH value of cleaning solution must range from 7.0 to 10.5.

 The maximum using times of high temperature and high pressure sterilization of respiratory

circuit is 2000 times.

 The breathing circuit must be cleaned and sterilized before use by each patient.

12.1 Housing Cleaning and Disinfection of Anesthesia Machine

1. Turn off the anesthesia system and disconnect the AC power before cleaning.

2. Use distilled water to wet the lint-free cloth and properly clean the display, work table, and the o
uter surface of the main unit.

3. Please disinfect with sodium hypochlorite solution, then use medical alcohol (75%) detergent, P
H value between 7.0 and 10.5, use a lint-free cloth to wipe the display, workbench, the outer sur
face of the main machine, etc.

4. The casing is free from signs of deterioration that can be detected by the naked eye, and the mar
king of the silk screen does not change.

Warning

 Liquid infiltrating into the control assemblies may damage the equipment or cause personal
injury. During cleaning the housing, 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.

12-2
12.2 Remove and Assemble the Cleanable and Disinfectionable
Components of the Breathing System

To clean and sterilize the breathing system, you are required to disassemble the breathing system
components that can be cleaned and sterilized.
.

Fig. 12-1 Assemblies of the Breathing System

Item Description Item Description

1 Bag support column 9 Main body, breathing
system circuit
2 Expiratory/Inspiratory check valve 10 Sealing Washer
cap
3 Expiratory/Inspiratory check valve 11 Collar Clamp
pedestal
4 Expiratory/Inspiratory check valve 12 POP-OFF Valve
5 Flow sensor 13 Folded Sack Holder

12-3
 6 Connector nut of respiratory tube 14 Folded Sack

7 Respiratory Tube Joint 15 Bellows Cover

8 CO2 canister

Components marked with 134 °C are high temperature and pressure resistant, They can be
hand-washed or machine-washed (using soft cleaning agent with pH <10.5), and then be rinsed
thoroughly and air-dried. All components, exception for the oxygen sensors, airway gauges and
disposable flow sensors, can be washed.

If the flow sensors are made of plastics, please refer to the directive rules given in “12.3.8 Flow
Sensor”.

12.2.1 Disassemble the CO2 Canister

1 Hold the canister with your right hand, and meanwhile push counterclockwise the release
latch with your left hand so as to release the lock of the canister.

2 Take out the canister with your right hand.

Warning

 CO2 absorbent is a type of high-causticity substance, and is very harmful to eyes, skin and
breathing system of human beings. In case any body parts are stained with CO2 absorbent
by accident, wash the parts with water. If irritation is not eliminated after washing, see a
doctor for help immediately.

12.2.2 Disassemble the Oxygen Sensors

1. Remove one end of O2 sensor cable from the corresponding oxygen sensor port “ ” of
the host, and remove the other end of the oxygen sensor cable from the oxygen sensor port
“ ”.

12-4
 2. Move outward the oxygen sensor along the channel, and take it out.

Caution

 Never immerse an O2 sensor or its connector in any type of liquid. Dispose of the O2 sensor
according to the manufacturer’s specifications.

 Do not clean the inner surface of the O2 sensor.

12.2.3 Disassemble the Breathing Tube, Y-piece and mask

Caution

 To disassemble the breathing tube, hold the connectors at both ends of the breathing tube so
as not to damage the breathing tube.

 Do not reuse filters. Discarded filters shall be disposed as per local laws and regulations, or
hospital disposal regulations. Do not directly throw them away.

1 Remove the mask from the joint;

2 Remove the filter from Y-piece, and then remove the Y-piece.

3 Remove the expiratory hose from expiratory connector, and inspiratory hose from
inspiratory connector of the breathing system.

12-5

2
12.2.4 Disassemble the Manual Bag
Just remove the manual bag from the breathing system, as shown in the figure below:

 The anesthesia machine is provided with manual support column.

12.2.5 Disassemble the Airway Gauge

1. Forcibly push away the CPC connector latch with your left hand, and lift up the airway
gauge with your right hand.

2. When the CPC connector latch is released, pull out the airway gauge.

12-6
12.2.6 Disassemble the Manual Support Column
1 Rotate the locking nut counterclockwise.

2 Hold the manual support column with your right hand, and remove the manual support
column from breathing system with your left hand.

12.2.7 Disassemble the Bellows Assembly

1 Hold the bellows cover with both hands, and then rotate the bellows cover
conterclockwise. Lift up the bellows cover when the bellows cover is separate from the
latch on the base.

12-7
2 Remove the folded sack from the folded sack holder.

3 Press the collar clamp towards the center, and remove the folded sack holder.

4 Remove the collar clamp.

5 Remove the POP-OFF valve.

12-8
 Warning
 Never disassemble the pressure relief valve. Otherwise, the pedestal and diaphragm may be
damaged and further endanger patient safety.

6 Remove the sealing washer.

12.2.8 Disassemble the Flow Sensor

1 Rotate the respiration connector nut counterclockwise, and remove the nut.

1
2 Remove the breathing tube connector from the breathing interface horizontally.

3 Pull the flow sensor out of the respiration port horizontally.

12-9
 3
12.2.9 Disassemble Expiratory Check 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.

3 Take out the seal ring.

4 Take out the valve.

5 Take out the valve base.

3

12.2.10 Disassemble Inspiratory Check Valve Assembly

For disassembling procedure of Inspiratory check valve assembly, refer to 12.2.9 Disassemble
Expiratory Check Valve Assembly.

12-10
12.2.11 Disassemble the Breathing Circuit System
1 Ensure that all the above-mentioned assemblies
are disassembled. Then hold up the breathing
circuit system by one hand, and push and open
the fixation latch of the circuit adapter by the
other hand.

2 Remove the breathing circuit system by both

hands from the circuit adapter.
1

Caution

 If it is very hard to push in or take out the breathing circuit system, apply lubricating oil
onto seal ring of airway connector of circuit adapter to reduce the frictional force.

12.2.12 Disassemble the AGSS Transfer and Receiving System

1 Remove the AGSS active discharge pipe on the AGSS gas outlet from hospital scavenging
system.

12-11
 2 Remove the 30mm outer cone connector of hose of the transfer system.

3 Remove the 30mm internal cone connector of hose of the transfer system.

4 Lift up the AGSS system from AGSS bracket and take it out.

12.2.12.1 Disassemble the Filter of AGSS Transfer and Receiving System

1. Refer to section 12.2.12 Disassemble the AGSS Transfer and Receiving System for dismantling AGSS
components from anesthesia machine.
2. Hold the AGSS cover with left hand, and rotate it to the right, as shown in the following figure

12-12
 2

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

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

12-13
5. Clean the filter.

12.2.12.2 Replace the Filter of AGSS Transfer and Receiving System

Refer to section 12.2.12.1 Disassemble the Filter of AGSS Transfer and Receiving System for
the steps of replacing filter gauze.

12.2.13 Disassemble External Vacuum Suction System

1. Loosen the nut, so that one end of the backup oxygen supply hose is separate from the
connector of external vacuum suction system.

2. Unscrew the four screws between the external vacuum suction system and its support.

12-14
3. Unscrew the support screws.

4. Disconnect the backup oxygen supply hose / backup air supply hose from the gas supply port.

12-15
12.3 Clean, Disinfect, Sterilize and Assemble the Breathing System
Components indicated with “134ºC” mark are sterilized through high-temperature vapor. For
example, components made of metal or glass can be sterilized in high-pressure high-temperature
vapor (not more than 134ºC for 4-6min). Utilize autoclave to raise the vapor pressure, and
temperature raises along. The bacterial protein may be solidified quickly in high temperature. The
method is quick and reliable for sterilization.If sterilization may be maintained for at least 30
minutes at 121ºC, all bacteria and most of brood cells may be killed.This type of components 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 are plastic products, and the specific cleaning procedures are described in 12.3.8
Flow Sensor.

Warning

 Never use talcum, zinc stearate, calcium carbonate, cornstarch or similar materials to avoid
adhesion. 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 treat them in
high-pressure and high-temperature environment.

 Check the components for damages, and replace them when necessary.
 The breathing circuit must be cleaned and sterilized before use by each patient.
 The maximum using times of high temperature and high pressure sterilization of respiratory

circuit is 2000 times.

All components of breathing system of the anesthesia machine can be cleaned and sterilized. Different
components have their own cleaning and sterilizing requirements.
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 ,disinfecting and sterilizing methods for components are recommended by the
Company.

Table 12.3-1 Recommended method for cleaning and disinfecting various components

Intermediate
Component Cleaning Sterilization
disinfection

CO2 Canister ★
Oxygen sensor ★
Breathing Tube,Y-piece and mask ★
Manual bag ★
Airway pressure gauge ★
12-16
 Intermediate
Component Cleaning Sterilization
disinfection

Manual support column ★

Bellows Assembly ★
Flow sensor ★
Expiratory Check Valve Assembly ★
Inspiratory Check Valve Assembly ★

Breathing circuit system ★

AGSS Transfer and Receiving ★

System

★: It indicates that this recommended cleaning and disinfection method can be utilized.

Cleaning: Gently wipe the surface of the cleaning parts with a damp cloth or cleaning cotton that
has been soaked in a soft, recommended cleaning agent (see Table 12.3-2 recommended cleaning
disinfectant table) to ensure that all surfaces of the parts are cleaned while This cleaning
requirement complies with the disinfection regulations and procedures of the medical institution.
After cleaning, gently wipe the surface of the cleaning part with a lint-free cloth or medical
cleaning cotton that has been soaked in medical clean water (recommended water temperature is
40 °C). Finally, dry it with a dry, lint-free cloth.

Intermediate disinfection: First use the hospital-approved disinfectant or recommended

disinfectant (see Table 12.3-2 recommended cleaning disinfectant table) to soak the parts for about
3 minutes for intermediate disinfection, and the intermediate disinfection requirements meet the
disinfection regulations and procedures of medical institutions. If there is any conflict, the
disinfection regulations and procedures of the medical institution shall prevail. After the
disinfection is completed, gently wipe the cleaning parts with a lint-free cloth or medical
cleaning cotton that has been soaked in medical clean water (recommended water temperature is
40 °C). The surface would be dry naturally or dry it with a dry, lint-free cloth.

Sterilization: First use the recommended cleaning agent (see Table 12.3-2 recommended cleaning
disinfectant table) to rinse clean parts, then use high temperature and high pressure steam
sterilization, and require this sterilization to meet the disinfection regulations and procedures of
reference medical institutions, recommended method 1: Maintain effective sterilization time at
temperature 121 °C for at least 30 min; recommended method 2: maintain effective sterilization
time at temperature 134 °C for about 4 min-6 min; After disinfection and sterilization, remove the
12-17
 parts and drain the remaining distilled water, then rinse with medical clean water (recommended
water temperature of 40 °C), and dry it naturally or in a ventilated place with a temperature of less
than 70 °C.
The following table is the recommended cleaning and disinfecting agent:
The cleaning disinfectants listed below have been tested that didnot damage the breathing
components. The listed cleaning disinfectants may not be available in all countries or regions.
Please comply hospital‟s instructions for the cleaning disinfectants.

Caution

 For the cleaners that are not in the cleaner list, their PH value should be between 7.0 and
10.5.

Table 12.3-2 Recommended Cleaning Disinfectant Table

Cleaning and Recommended cleaning disinfectant Concentration
disinfection method
Cleaning Medical clean water /
Soap water (weakly alkaline) /
Pure distilled water /
Intermediate disinfection Medical alcohol 75%

Sodium hypochlorite solution 10% effective chlorine

12.3.1 CO2 Canister

Caution

 Care must be taken when handling the absorbent as it is a corrosive irritant.

 Check the seals before installing the CO2 canister assembly. If not, replace the seals.

1. Please refer to12.2.1 Disassemble the CO2 Canisterfor Removal of the CO2 canister.
2. Clean and sterilize the CO2 canister as per the methods recommended in the table 12.3-1
recommended methods for cleaning and disinfecting various components given in 12.3
Clean,Disinfect,andAssemblethe Breathing System.

12-18
 3. After cleaning and sterilization is completed,the CO2 canister is thoroughly dried, pour CO2
absorbent into the CO2canister.

4. Please refer to 5.2 Install the CO2 Absorbent Canister,assemble the CO2 Absorbent Canister onto
the breathing system.

5. Check and test the system before use. For details, see 4.5.2 Breathing System Leak Test in
Mechanical Ventilation Mode.

12.3.2 Oxygen Sensor

Warning
 Never soak breathing system and oxygen sensor into the liquid together or treat them in
high-pressure and high-temperature environment.

 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 refer to 12.2.2 Disassemble the oxygen sensor for disassembling the oxygen sensor;

2. Please clean the oxygen sensor as per the methods recommended in the table 12.3-1
recommended methods for cleaning and disinfecting various components given in 12.3
Clean, Disinfect,Sterilize and Assemble the Breathing System.

3. After cleaning is completed,the oxygen sensor is thoroughly dried, assemble oxygen

sensors as per 5.1.7 Assemble the Oxygen Sensor.

4. Check and test the system before use. For details, see 4.5.2 Breathing System Leak Test in
Mechanical Ventilation Mode.

12.3.3 Breathing Tube ,Y-piece and mask

Caution

 When you assemble, clean or sterilize the breathing tube, hold the connector fitted at both
ends of the breathing tube, so as not to damage the breathing tube.

1. See 12.2.3 Disassemble the breathing tube, Y-piece and mask for removal of the breathing
tube, Y-piece and mask.

2. Clean and sterilize the Breathing Tube,Y-piece and mask as per the methods recommended
in the table 12.3-1 recommended methods for cleaning and disinfecting various

12-19
 components given in 12.3 Clean,Disinfect,Sterilize and Assemble the Breathing System.

3. After cleaning and sterilization is completed,the Breathing Tube,Y-piece and mask are
thoroughly dried, please refer to5.1.6Assemble the Breathing Tube,Y-piece and mask,
assemble the Breathing Tube ,Y-piece and mask onto the breathing system.

4. Check and test the system before use. For details, see 4.5.2 Breathing System Leak Test in
Mechanical Ventilation Mode.

12.3.4 Manual bag

1. Please refer to 12.2.4 Disassemble the Manual bag for disassembly of the Manual bag.

2. Clean and sterilize the manual bag as per the methods recommended in the table 12.3-1
recommended methods for cleaning and disinfecting various components given in12.3
Clean, Disinfect, Sterilize and Assemble the Breathing System.

3. After cleaning and sterilization is completed,verify that the manual bag is thoroughly dry,
and then assemble the manual bag as per5.1.3Assemble the Manual bag.

4. Check and test the system before use. For details, see 4.5.3 Breathing System Leak Test in
Manual Ventilation Mode.

12.3.5 Airway Pressure Gauge

1. Please refer to 12.2.5 Disassemble the airway gauge for disassembly of the airway pressure
gauge.

2. Clean the airway pressure gauge as per the methods recommended in the table 12.3-1
recommended methods for cleaning and disinfecting various components given in12.3
Clean, Disinfect,Sterilize and Assemble the Breathing System.

3. After cleaning is completed,verify that theairway pressure gauge is thoroughly dry, and
then assemble the airway pressure gauge as per5.1.8 Assemble the Airway Pressure Gauge.

4. Check and test the system before use. For details, see 4.5.2 Breathing System Leak Test in
Mechanical Ventilation Mode.

12.3.6 Manual support column

1. Please refer to 12.2.6 Disassemble the Manual support column for disassembly of the
Manual support column.

2. Clean and sterilize the Manual support column as per the methods recommended in the
table 12.3-1 recommended methods for cleaning and disinfecting various components given
in12.3 Clean, Disinfect,Sterilize and Assemble the Breathing System.

3. After cleaning and sterilization is completed,verify that theManual support column is

thoroughly dry, and then assemble the Manual support column as per5.1.2Assemble the

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 Manual Support Column.

4. Check and test the system before use. For details, see 4.5.3 Breathing System Leak Test in
Manual Ventilation Mode.

12.3.7 Bellows Assembly

Caution

 The folded sack assembly shall not be soaked in warm water and cleaning solution for more
than 15 minutesto prevent expansion or aging.
 When you air-dry the folded sack, hang and expand it adequately. Otherwise, adhesion
might occur in the folded sack.
 Disassemble the bellows assembly for cleaning; otherwise, drying may take a long time.

 To conduct high-pressure and high-temperature sterilization to the bellows assembly,

assemble the bellows assembly properly. During the high-pressure and high-temperature
sterilization, the bellows assembly shall be positioned upside down.

1. See 12.2.7 Disassemble the Bellows Assembly for Removing the Bellows Assembly.

2. Clean and sterilize the bellows assembly as per the methods recommended in the table
12.3-1 recommended methods for cleaning and disinfecting various components given
in12.3 Clean, Disinfect,Sterilize and Assemble the Breathing System.

3. After cleaning and sterilization, spread out the components of the bellows assembly and
hang them in a ventilated place with a temperature less than 70 °C to dry;.

4. When the bellows assembly is thoroughly air-dried, check the components for damages,
and then conduct assembling as per the procedures described in 5.1.4 Assemble the
BellowsComponents. Connect the bellows assembly, ventilator and breathing system.

5. Check and test the system before use. For details, see 4.5.1 Bellows Tightness Test.

12.3.8 Flow Sensor

1. See 12.2.8 Disassemble the Flow Sensor for Disassembly of the Flow Sensor.

2. Clean the flow sensor as per the regulations issued by the hospital or as per the methods
recommended in the table 12.3-1 recommended methods for cleaning and disinfecting
various components given in 12.3 Clean, Disinfect, Sterilize and Assemble the Breathing
System.

3. After the cleaning and disinfection is completed, after the flow sensor is completely dry,
please refer to 5.1.5 Assemble the Flow Sensor to install the flow sensor;

4. Check and test the system before use. For details, see 4.5.2 Breathing System Leak Test in
Mechanical Ventilation Mode.
12-21
 Caution

 Never have the flow sensors in high-pressure and high-temperature environment for
disinfection.
 Never use high pressure gas or brush to clean the flow sensors.
 Never use unapproved cleaning agent containing polycarbonate.

 Do not clean the inner surface of flow sensor, only use a damping cloth to wipe its outer
surface.

 The flow sensor must be completely dry before it can be used.

Warning
 To assemble a flow sensor, tighten the locknut of respiration port; otherwise the measuring
function of flow sensors may be disabled.

 The respiration port that is connected to the respiration hose shall face downward;
Otherwise condensed moisture may flow into the breathing system and impact the flow
sensor measurement.

12.3.9 Expiratory check valve assembly

1. See 12.2.9 Disassemble Expiratory Check Valve Assembly for Disassembly of the Expiratory
check valve assembly.

2. Clean and sterilize the Expiratory check valve assembly as per the methods recommended
in the table 12.3-1 recommended methods for cleaning and disinfecting various
components given in12.3 Clean, Disinfect, Sterilize and Assemble the Breathing System.

3. After the cleaning and sterilization is completed, after the Expiratory check valve assembly
is completely dry, assemble the Expiratory check valve assembly according to the reverse
process of dismounting the Expiratory check valve assembly, according to 12.2.9
Disassemble Expiratory Check Valve Assembly.

4. Check and test the system before use. For details, see 4.5.5 Check Valve Inspection and Test.

Warning
 Never disassemble the check valve diaphragm and check valve cover.

 Push the check valve downwards forcibly to ensure secure assembling.

12-22
12.3.10 Inspiratory check valve assembly
1. See 12.2.10 Disassemble Inspiratory Check Valve Assembly for Disassembly of the
Inspiratory check valve assembly.

2. Clean and sterilize the Inspiratory check valve assembly as per the methods recommended
in the table 12.3-1 recommended methods for cleaning and disinfecting various
components given in12.3 Clean, Disinfect, Sterilize and Assemble the Breathing System.

3. After the cleaning and sterilization is completed, after the Inspiratory check valve assembly
is completely dry, assemble the Inspiratory check valve assembly according to the reverse
process of dismounting the Inspiratory check valve assembly according to 12.2.10
Disassemble Inspiratory Check Valve Assembly.

4. Check and test the system before use. For details, see 4.5.5 Check Valve Inspection and Test.

Warning
 Never disassemble the check valve diaphragm and check valve cover.

 Push the check valve downwards forcibly to ensure secure assembling.

12.3.11 Breathing Circuit system

1. After ensuring that the components described above have been removed, see 12.2.11
Disassemble the Breathing Circuit System for Disassembly of the Breathing Circuit
System.

2. Clean and sterilize the breathing circuit system as per the methods recommended in the
table 12.3-1 recommended methods for cleaning and disinfecting various components
given in12.3 Clean,Disinfect,Sterilize and Assemble the Breathing System.

3. After sterilization is completed, the breathing circuit system is hung upside down in a
ventilated place with a temperature less than 70 °C to dry;

4. After cleaning and sterilization, after the Breathing System has completely dried, please
refer to 5.1.1 Assemble the Breathing Circuit Systemto install the breathing circuit system,
and then install the components as described above to ensure the formation of a complete
breathing system.

5. Check and test the system before use. For details, see 4.5.2 Breathing System Leak Test in
Mechanical Ventilation Mode.

12.3.12 AGSS Transfer and Receiving System

1. See 12.2.12 Disassemble the AGSS Transfer and ReceivingSystem for Disassembly of the
AGSS transfer and receiving system.

12-23
 2. Shake the removed filter and shake the dust and impurities from the filter net until it
reaches a satisfactory cleaning effect;

3. Clean the AGSS transfer and receiving system as per the methods recommended in the
table 12.3-1 recommended methods for cleaning and disinfecting various components
given in12.3 Clean, Disinfect, Sterilize and Assemble the Breathing System.

4. After the cleaning is completed, after the AGSS Transfer and Receiving System is
completely dry, please refer to 5.10.2 Assemble the AGSS to install the AGSS system.

5. Check and test the system before use. For details, see 4.7 AGSS Transfer and Receiving
System Test.

Warning
 AGSS shall not be treated in high-temperature disinfection.

Caution

 When cleaning is over, do not assemble the float onto the AGSS before it is thoroughly
dried. Any small amount of liquid may cause the float to stick to the guide or observation
window, causing the float to fail to reflect the true flow rate

 The concentration for soaking, disinfection and cleaning shall be strictly complied with the
instructions of the disinfecting solution.

12.3.13 Vacuum Suction System

Note

 Please refer to the user manual supplied with the external vacuum suction system for
cleaning, disinfection and installation information.

Caution
 Before use must check ensure that air pressure in the rang of 280-550kPa.
 The maximum negative pressure of vacuum suction system is not less than 75kPa.

12-24
12.3.14 Battery

Caution

 To extend the service life of batteries, use the battery at least once a month, and charge them
when the batterycharge is used up.

 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 service life may
be reduced. It is recommended that batteries be replaced every 3 years.

 In case of battery fault, contact the personnel of the manufacturer for replacement. The user
must not replace it by themselves.

 The time the battery is powered depends on the configurations and operation of the device.
 After the main power supply is interrupted, when the “ON-OFF” button is kept on, after
the interruption time exceeds 30s, there is internal power supply that can support normal
operation.

12-25
 Chapter13 Maintenance and Failure Recovery

13.1 Maintenance Basics

Warning
 Do not use the faulty anesthesia machine.All repairs and maintenance shall be carried out by
authorized service representatives.

 Adopt a cleaning and disinfection plan that meets you disinfection and risk management
requirements.

 Be careful when handling an absorbent because it is a corrosive stimulus.

 Please use approved anesthesia equipment or special lubricant for O2 equipment.

 Please don’t use lubricant containing oil or grease, which may have a fire or explosion hazard
when O2 reaches a certain concentration.

 Used equipment might be contaminated by blood or body fluid. Please observe relevant
disinfection control and safety regulations.

 Moving parts and detachable components may cause hazard of hand nipping/crushing;
therefore, move or replace system components with more care.

Do not use faulty equipment. Contact the service representative authorized by the Company
to fulfill all required maintenance, or the qualified professionals to fulfill the replacement and
maintenance of parts listed in the User‟s Manual.

When maintenance is over, test the equipment and ensure that the equipment works normally
and meet the requirements of specifications.

Caution

 Personnel without experiences in maintenance of such equipment must not service the
equipment.

 Replace damaged parts with the ones produced or sold by the Company. When replacement is
over, perform testings to ensure that the equipment conform to the specification requirements
of manufacturer.

13-1
  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.

 Do not immerse the O2 sensor or its connecter in any type of liquid.

 Do not clean the inner surface of the O2 sensor

13.2 Maintenance Schedule

Caution

 In this schedule, the minimum maintenance frequency is based on a typical use of 2000
operating hours per year. If the actual use time is longer than 2000 hours, the frequency of
equipment maintenance shall be higher in a year.

 When cleaning and installing,please check whether the parts and sealing rings are damaged
and replace or repair if necessary.

Minimum maintenance
Maintenance
frequency

Clean the outer surfaces.

Daily 21% O2 calibration (oxygen sensors of the breathing system).

APL accuracy check in Manual/spontaneous ventilation.

Every 2 weeks Drain the Anesthesia Vaporizer.

100% O2 calibration (oxygen sensors of the breathing system).

Monthly AGSS filter check

Inspection of vacuum suction system

During cleaning and Check if components and seal rings are damaged, and replace or repair them
assembling when necessary.

Replace the vaporizer base and seal rings of the breathing system port. For
Yearly details, contact the after-service department of the Company.

CO2 module calibration.

Every 3 years Replace the built-in battery. For details, please contact the after-service

13-2
Minimum maintenance
Maintenance
frequency

department of the Company.

Use a new washer on the backup cylinder port every time a new backup cylinder
is to be assembled.
If the colour of CO2 absorbent varies, replace CO2 absorbent of the canister.
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 transfer system are broken, replace them.

13.3 Maintenance of Breathing System

If any parts are found to be cracked, broken, deformed or worn during breathing system
cleaning, replace them. For details, refer to 12.2 Remove and Assemble the Components
Allowing Cleaning and Disinfection of the Breathing System and 5.1 Assemble the Breathing
System.

13.4 O2 Calibration

Warning
 Please do not implement the calibration procedure when the system is connected to a patient.

 When calibrating an oxygen sensor, the environmental pressure must be identical with the
environmental pressure where oxygen transfers in the breathing system. If not, the
monitoring values may exceed the limits.

 Before calibrating an oxygen sensor, disassemble the oxygen sensor. Verify that oxygen sensor
and the assembling place do not have accumulated water, and then re-assemble the oxygen
sensor.

 If oxygen sensor is not equipped with or not intended to use, it is unnecessary to perform O2
calibration.

13-3
13.4.1 21% O2 Calibration

Caution

 If the measurement error 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 some technical alarm is given. Take measures to
remove the alarm, and then calibrate the O2 sensor again.

 If calibration fails many a time, replace the oxygen sensor, and perform calibration over
again. If calibration still fails, contact the service personnel or the Company in time.

 The discarded oxygen sensors shall be treated as per relevant regulations 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 soft key ( ) to
access the screen of [Standby].

2. Select [O2 Calibration] menu → [21% O2 Calibration] , and open the [21% O2
Calibration] menu, and access the 21% O2 Calibration screen.

3. Remove the oxygen sensor from breathing system, and place it in the 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 on the screen.

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 on the screen. Otherwise, prompting messages [Calibration Result FAIL] and
[Repeat] will be displayed, and recalibration is required in such a case.

7. Select [Exit] .

13.4.2 100% O2 Calibration

13-4
 Caution

 If 100% O2 calibration fails, check whether or not some technical alarm is given. Take
measures to remove the alarm, and then calibrate the O2 sensor again.

 If calibration fails many a time, replace the oxygen sensor, and perform 21% O2 calibration
over again. When 21% O2 calibration is successful, perform 100% O2 calibration. If 100% O2
calibration still fails, contact the service 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 soft 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 screen.

4. Ensure the patient is disconnected from the system.

5. Align the patient port to the atmosphere.

6. Turn on O2 supply, the regulated flow shall be at least 8L/min; turn off other gas supply.

7. Wait for 2~3 minutes, or in the [100% 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 on the screen.

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.

13.5 Airway Gauge Zeroing

When Mechanical or Manual/spontaneous stops, the airway pressure should be about zero. If
the pointer of airway gauge does not return to zero, the pressure indication of airway gauge
may become inaccurate. In such a case, it is necessary to zero the airway gauge as per the steps
given below:

13-5
 1. Stop Mechanical or Manual/spontaneous, connect the respiration pipeline to the
breathing system, allow the patient end port of respiration pipeline to be open to the
atmosphere, and make sure that the folded sack drops completely

2. Use a small flat screwdriver to open the latch of the airway gauge lens, and then remove
it.

3. Use a screwdriver to adjust the zeroing screw, and adjust the pressure gauge pointer to
zero.

4. Set the Manual/mechanical ventilation switch to its mechanical control mode.

5. Insert the Y-piece into the leak hunting plug to seal the respiratory airway.

6. Push the oxygen flush valve repeatedly to make the pressure gauge pointer swinged.

7. Remove the Y-piece from leak hunting plug and release the oxygen flush button. Then
check whether or not the gauge pointer returns to zero

8. If the pointer fails to return to zero, repeat the above-mentioned procedures.

9. If pointer can return to return to zero normally, directly press the lens of airway gauge,
and assemble the gauge properly. If the pointer still fails to return to zero, please contact
the after-service department of the Company.

13.6 Maintain AGSS Transfer System

13.6.1 Maintain the Hose of AGSS Transfer System

Check the hose of transfer system. If there is any damage, please replace it.

13.6.2 Maintain the Filter of AGSS Transfer System

Impurities and dusts may clog the filter during using AGSS transfer system. Use the following two ways

to check the filter:

 When using the filter, if the AGSS float isn‟t floating, the filter may be clogged.

 Place the AGSS canister at horizontal level to see whether the filter is clogged.

If the filter is clogged, please refer to section 12.3.12 AGSS Transfer and Receiving System to clean or

replace it.

13-6
13.7 Maintenance of vacuum suction system

Note

 Please refer to the user manual supplied with the external vacuum suction system for
maintenance information.

13.8 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 Manual/Mechnical ventilation Control switch to its position [Mechanical ] ( ).

5. Make sure that adequate gas supply is available.

6. Turn on the O2 supply, 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.

13.9 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 canister, 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
canister, 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 upwards to open the drain valve. The water
accumulated will be discharged, as shown in the right figure:

13-7
 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.

13-8
 Chapter14 Accessories

Warning
 Only the accessories specified in this chapter may be used. Using other accessories may lead
to incorrect measured values or equipment failure.

 Disposable accessories can be used only once, and their reuse may cause performance
reduction or cross infection.

 If an accessory package or an accessory is broken, do not use it.

 All accessories 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 anesthetics and are expected to cause no adverse reaction when they
are exposed to human body, and they shall not work with inflammable anesthesia gasses.

 The discarded accessories shall be treated as

 per local laws and regulations, or hospital regulations, Do not throw them directly.

 Accessories that are not in direct contact with the human body do not require disinfection.
The detailed method for disinfection of accessories directly in contact with the human body
is described in the attached Manual.
 When the device and its accessories reach the end of their service life, they must be disposed
of in accordance with the guidelines for the management of such products as well as local
regulations for contaminated and biohazardous goods.
 To use additional bacteria filter if sample gas is to be returned to the breathing system.

Plug-in monitoring module list

PN Recommended
Name Remarks model replacement manufacturer
period

Masimo AG 115-003990-00 5 years

Anesthet C-26
(sidestream)
ic gas Shenzhen Comen
Masimo AG+O2 115-004499-00 5 years
monitori C-28 Medical Instruments Co.,
(sidestream)
ng Ltd.
Artema AG 115-004498-00 5 years
module C-27
(sidestream)

14-1
 Artema AG+O2 115-002238-00 5 years
C-29
(sidestream)

Masimo CO2 115-003994-00 5 years

C-13
(sidestream)）

Masimo CO2 115-001861-00 5 years

Carbon C-17
(mainstream)
dioxide
Respironics 115-003993-00 5 years
monitori
CO2 C-11
ng
(mainstream)
module
Respironics 115-003996-00 5 years
CO2(sidestream C-16
)

Dual 115-003992-00 5 years

frequenc
BIS C-31
y index
module

Plug-in monitoring module attachment list

Access PN Recommended
ory Remarks Model replacement manufacturer
name period

MASIMO bypass 040-000017-00 CAT.N Single use

CO2/AG sampling O.1082 Masimo Sweden AB
tube 10

Anesth ARTEMA 040-000708-00 100-00 per month

etic gas DRYLINE II 0080-0
monitor Adult Water Cup 0
ing ARTEMA 040-000709-00 per month
100-00
module DRYLINE II
0081-0 ARTEMA Technology
accesso Children's Water
0
ries Cup

ARTEMA 040-000710-00 Single use

60-152
DRYLINETM™
00-00
Adult Gas
14-2
 Sampling Tube
(2.5M)

ARTEMA 040-000711-00 Single use

DRYLINETM™
60-153
Child Gas
00-00
Sampling Tube
(2.5M)

MASIMO 099-000006-00 CAT.N 5 years

mainstream CO2 O.2001
external module 01

MASIMO 040-000216-00 CAT.N Single use

mainstream O.1062
CO2/AG adapter 20

MASIMO 040-000217-00 CAT.N Single use Masimo Sweden AB

mainstream O.1062
CO2/AG adapter 60

MASIMO 040-000017-00 Single use

CAT.N
Carbon sidestream
O.1082
dioxide CO2/AG sampling
10
monitor tube
ing Respironics 099-000005-00 5 years
REF:1
module mainstream CO2
015928
accesso external module
ries
Respironics 040-000021-00 Single use
REF:6
mainstream adult
063-00
airway adapter

Respironics 040-000022-00 Single use RespironicsNovametrix，

mainstream REF:6 LLC

neonatal airway 312-00

adapter

Respironics 040-000024-00 Single use

REF:3
Sidestream
473AD
child/adult airway
U-00
adapter (with

14-3
 dehumidification
tube)

Respironics 040-000026-00 Single use

Sidestream
REF:3
child/baby airway
473IN
adapter (with
F-00
dehumidification
tube)

Dual COVIDIEN BIS 099-000132-00 186-01 5 years

Freque module 95-SF
ncy BIS adult 040-000630-00 186-01 Single use
Index 4-electrode sensor 06 Covidienllc
Module
040-001145-00 Single use
BIS child 186-02
Access
electrode 00
ories

Oxygen 040-000196-00 MOX- 1 year

\ City Technology Ltd.
Sensor 3

Anesthesia breathing circuit and accessories list

PN Recommended
Name Remarks model replacement manufacturer
period

Rubber Breathing 040-001027-00 Single use

504-01
Bag (Latex Free,
2
0.5L)

Rubber Breathing 040-001028-00 Single use

504-01
Bag (Latex free,
Anesthe 2
1 L) Vincent Medical (Donggu
sia
Rubber Breathing 040-001029-00 Single use an) Mfg. Co. Ltd.
circuit 504-01
Bag (Latex free,
2
2 L)

Rubber Breathing 040-001030-00 Single use

504-01
Bag (Latex free,
2
3 L)

14-4
 Disposable adult 040-000272-00 504-00 Single use
bellows kit 1

Disposable 040-000273-00 Single use

504-00
Pediatric Bellows
2
Kit

Reusable adult 040-001016-00 1 year

9014-0
breathing
8
tube(150cm)

Reusable 040-001017-00 1 year

pediatric 9013-0
breathing 8-01
tube(150cm)

Reusable adult 040-001019-00 1 year

9014-0
breathing
6
tube(120cm)

Anesthe Reusable 040-001020-00 1 year

sia pediatric 9013-0

VADI MEDICAL TECH
breathin breathing 6-01
NOLOGY CO., LTD
g tube tube(120cm)

set Y-type connector 040-001001-00 1 year

G-3110
(adult, without
30
sampling port)

L-connector 040-001002 -00 G-3110 1 year

(adult) 25

Y-type connector 040-001003-00 1 year

G-313
(pediatric, with
005-11
sampling port)

Straight 040-001004-00 1 year

G-3110
connector
03-3
(pediatric)

Pipeline 040-000275-00 1 year

High temperature
assembl 73001
Y-type connector GaleMed Medical
y

Pipeline High temperature 040-000274-00 72201 1 year

14-5
assembl L-type connector
y

Pipeline 040-000501-00 Single use

assembl Rubber bag (3L) 70140
y

Soft silicone 040-000697-00 1 year

mask (big 5121
pediatric 1 #)

Soft silicone 040-000283-00 1 year

Oxygen
mask (pediatric 5122
mask
2#)

Soft silicone 040-000286-00 1 year

mask(big 5135
pediatric 5#)

Pipeline Reusable adult 040-000703-00 1 year

assembl breathing 38006
y tube(120cm)

Inflatable 040-000700-00 Single use

anesthesia
mask(big 5312
pediatric 1 #,
disposable)

Inflatable 040-000288-00 Single use

anesthesia mask
5313
(pediatric 2#,
Oxygen
disposable)
mask
Inflatable 040-000701-00 Single use
anesthesia mask
5314
(big pediatric 3#,
disposable)

Inflatable 040-000702-00 Single use

anesthesia mask
5315
(adult 4#,
disposable)

14-6
 Inflatable 040-000291-00 Single use
anesthesia mask
5316
(big adult 5#,
disposable)

Silicon round 040-001010-00 S-100- 1 year

face mask#0 0

Silicon round 040-001011-00 S-100- 1 year

face mask #1 1

Silicon round 040-001012-00 S-100- 1 year

face mask #2 2

Silicon round 040-001013-00 S-100- 1 year

face mask #3 3
Anesthe Silicon round 040-001014-00 S-100- 1 year
VADI MEDICAL TECH
sia face mask #4 4
NOLOGY CO., LTD
mask
Silicon round 040-001015-00 S-100- 1 year
face mask #5 5

Inflatable mask#0 040-001031-00 6001 Single use

Inflatable mask#1 040-001032-00 6002 Single use

Inflatable mask#2 040-001033-00 6003 Single use

Inflatable mask#3 040-001034-00 6004 Single use

Inflatable mask#4 040-001035-00 6005 Single use

Inflatable mask#5 040-001036-00 6006 Single use

Filter of suction 082-000226-00 FILTM Single use

equipment -01
Vacuum Gentec (Shanghai)
Suction tube of 082-000227-00 ST8-4 Single use
suction Corporation
suction
equipment

14-7
 Chapter15 Installation and Specifications

15.1 System Gas Circuits

15.1.1 Gas Circuit Diagram

43
28 42
41
11 45 NO
12 NC

8 9 10 51
13 污气处理
病人 46
27 40
14 15 18

16 17
52 44
23 22 53
36 38
1
7 19
24 20 35
6
2 21 34
25 48

35
32
NO
NC 33
3 26 31
7 24 49
O2 P 37

39 47
30
29 50
4
7 24
6
5
蒸发罐 蒸发罐

Fig. 15-1 Gas Circuit Diagram

Item Description Item Description

O2 P-line Negative pressure valve for

1 28
spontaneous respiration

2 O2 cylinder 29 Double-vaporizer support

3 Air P-line 30 Check valve

N2O P-line Pressure relief valve

4 31
(38kPa)

15-1
5 N2O cylinder 32 ACGO switch

6 Pressure regulator (0.4 MPa) 33 Inspiratory valve

7 Safety valve (0.7MPa) 34 CO2 canister

Filter
8 35
Bypass system

9 Pressure regulator (0.2 MPa) 36 Expiratory valve

10 Filter 37 Inspiratory flow sensor

11 Inspiratory flow regulator 38 Expiratory flow sensor

Mechanical overpressure O2 concentration sensor

12 39
valve (110cmH2O)

Pop-Off valve Gas reservior and noise

13 40
reducer

Electromagnetic switch Manual/Mechanical switch

14 41
valve

15 PEEP valve 42 Bag

16 Gas reservior 43 APL valve

17 Gas resistance 44 Gas monitoring module

18 Expiratory valve 45 Bellows assembly

19 O2 flush valve 46 Auxiliary O2 supply

20 Pressure switch (37kPa) 47 Airway pressure gauze

21 Flow limiter 48 Patient-end

22 System switch 49 22mm standard connector

23 Pressure switch(0.2MPa) 50 Single-vaporizer support

24 Pressure regulator（0.2MPa） 51 AGSS standard connector

15-2
 O2-N2O cutoff valve Pressure regulator
25 52
（0.24MPa）

26 Flowmeter 53 Manual drain valve

Pressure relief valve

27
（10cmH2O）

15.1.2 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 200 kPa. Backup cylinder gas supplies include 3
types i.e. O2,Air and N2O (only allows to select two of the three gases. Oxygen and nitrous
oxide are taken as the examples in the figure below), they enter into the system respectively
through backup-cylinder gas supply ports 2 and 5. Their ranges of operating pressure are
respectively 6.9 ~15 MPa and 4.2~6 MPa, and are reduced to 300 ~500 kPa by pressure
regulator 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 gauges with color codes are used to display the pressure
pipeline gas supplies and backup 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. Gauge displays the pressure of gas cylinders and pipelines. Regulator can reduce the
gas cylinder pressure to a proper systemic pressure. Pressure relief valve can 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.

 When supply pipelines are connected, keep the gas cylinder valves in their OFF
position.

 When the system is not in use, cut off the gas supply lines.

Warning

 When pipeline gas supply is in use, do not set the cylinder valve to “ON”. Cylinder gas supply
15-3
 will exhaust. In such a case, gas supplies may be inadequate when a pipeline fault occurs.

15.1.3 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
supply 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.

15.1.4 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.
N2O 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.

Warning
 When the pressure of O2 supply is lower than 100 kPa, N2O supply is automatically cut off
by O2-N2O cut-off valve, but the air supply will not be affected.

15.1.5 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.

15.2 Electrical Connections

15.2.1 Electrical Circuit Diagram

15-4
 20
21
19 22
23
24

1 2 7 26
27
28
3 29
25 30
8
31
4
9
32 33
6 5 10 18
34 35
11
37
38
13
12 39 40
14 36
41
15 16

17

15.2.2 Component List

Item Parts Item Parts

1 AC input filter socket 22 Indicating lamp
2 Fuse 23 Alarm lamp
3 Isolation transformer board 24 Beeper
4 Isolation transformer 25 Main control board
5 Breaker 26 LCD screen
6 AC auxiliary output socket 27 Touch screen
7 AC/DC power switch 28 Alarm speaker
8 Lithium battery 29 SD card
9 System switch 30 USB
10 Power fan 31 Network connector
11 Isolation transformer fan 32 Electronic flow meter board
12 Flowmeter backlight switch 33 flow sensor

15-5
 Single tube flowmeter backlight
13 34 Infrared relay board
board
Multi-tube flowmeter backlight
14 35 Plug-in module
board
15 Workbench lighting switch 36 Monitoring board
16 Workbench lighting board 37 Calibration serial port
17 Circuit heater 38 Switch signal
18 DC/DC power board 39 O2 sensor adaption board
19 Keyboard 40 O2 sensor
Zero valve, proportional valve,
20 Shuttle 41
safety valve
21 Buttons
Note:
1.AX-600 is not equipped with electronic flow meter and O2, N2O, AIR flow
sensor.AX-600,AX-700,AX-700A and AX-800 are equipped with electronic flow meter and O2, N2O, AIR
flow sensor.
2.AX-600 is equipped with multi-tube flowmeter backlight, AX-700,AX-600,AX-700,AX-700A and AX-800
are not equipped with multi-tube flowmeter backlight.
3.AX-600, AX-700,AX-700A have buttons,and AX-800 have no buttons.

15.3 IEC 60601-1(GB9706.1) Applied Standard for Classification

and Components of Products
Anesthesia machine System Classification:

Classified by category of anti-electric shock Class I, Device With Internal Power Supply, Normal
Mobile Device
Classified by degree of anti-electric shock Defibrillation-proof Type BF Apply Part
Defibrillation-proof recovery time BIS: < 30 s; Others: <5 s
Classified by the safety degree under coexistence of Not suitable to apply in the place with flammable
flammable anesthetic gas and air or oxygen or nitrous anesthetic gas
oxide
Classified by the work mode Continuous working Device
Classified by degree of water proof IPX0 Type
Applicable standard IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC
60601-1-8, IEC 60601-1-9, ISO 80601-2-13, IEC

15-6
 60601-2-26, ISO 10079-3
The anesthesia machine is integrated with pressure limit device, expiratory gas volume
monitor, breathing system equipped with alarm system, pressure measurement device,
anesthesia breather system, vacuum suction system,anesthesia gas delivery device, anesthesia
respiration machine, O2 monitor and CO2 monitor, and it can be installed anesthesia-gas
purification/transfer and receiving system,. Where:

 AX-600,AX-700,AX-700A and AX-800 anesthesia machines conform to the standard of

ISO 80601-2-13;

 Pressure limit device, expiratory gas volume monitor and breathing system equipped with
an alarm system conform to Standard IEC 60601-2-13(GB 9706.29) and ISO 80601-2-13;

 Pressure measurement device and anesthesia ventilation system conform to Standard ISO
80601-2-13 and YY 0635.1;

 Anesthesia gas purification, transfer and receiving system conforms to Standard ISO
80601-2-13 and YY 0635.2;

 vacuum suction system conforms to Standard ISO 10079-3 and YY 0636.3;

 Anesthesia gas delivery device conforms to the Standard ISO 80601-2-13 and YY 0635.3;

 Anesthesia respiration machine conforms to Standard ISO 80601-2-13 and YY 0635.4;

 CO2 monitor conforms to Standard ISO 80601-2-55 and YY 0601;

 Alarm system conforms to Standard IEC 60601-1-8 and YY 0709;

 Anesthesia concentration analyzer conforms to Standard ISO 80601-2-55 and YY 0601.

15.4 Power Supply

AC mains
Input voltage 220 to 240 V
Input frequency 50/60 Hz
Input power 3.5A
Fuse T10 AL/250V
Auxiliary power supply (4-Way)
Output voltage 220 to 240 V 220 to 240 V 220 to 240 V 220 to 240 V
Output frequency 50/60 Hz 50/60 Hz 50/60 Hz 50/60 Hz
Total max output power 2.2A

15-7
 AC mains
Input voltage 100 to 127 V
Input frequency 50/60 Hz
Input power 7.0-6.0A
Fuse T10 AL/250V
Auxiliary power supply (4-Way)
Output voltage 100 to 127 V 100 to 127 V 100 to 127 V 100 to 127 V
Output frequency 50/60 Hz 50/60 Hz 50/60 Hz 50/60 Hz

Output power 4.0A 4.0A 4.0A 4.0A

Total max output power 4.5A

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 four power sockets for auxiliary equipment of anesthetic systems (eg,
evaporator, gas analyzer), do not connect other devices with the sockets, it may affect the
patient's leakage current. Overload is not allowed.

Internal battery

Number of battery 1 piece

Battery Type Li-ion battery

Rated battery voltage 11.1VDC

AX-600, AX-700,AX-700A：4400mAh
Battery capacity
AX-800：6600mAh

At least 30 min (when a fully-charged new battery is used, shutdown

Shutdown delay
takes place within 30 minutes after the first low battery alarm is given)

120 min (when a new fully-charged battery is used, at ambient

Minimum power-on time
temperature 25ºC)

AX-600,AX-700,AX-700A: Approximately 4h (running mode or

Charging time
standby mode)

15-8
 AX-800: Approximately 6h (running mode or standby mode)

15.4.1 Power Cord

Length： 5m

Voltage Rating： 100 ~ 240Vac

10A for 220~ 240Vac

Current capacity：
15A for 100 ~127Vac

Type： Three-wire power cord (medical grade where required)

15.5 Specifications for CO2 and AG modules

15.5.1 Specifications of MASIMOTM (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 CO2: 0 to 50 °C (32 to 122 °F) 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 CO2:
Meets the impact 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.
OR+/AX+:
Meets the impact 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, CO2: < 1.4 W (normal op.), < 1.8 W
(peak @ 5 VDC) AX+: < 1.6 W (normal op.), < 2.0 W

15-9
 (peak @ 5 VDC) OR+: < 2.0 W (normal op.), < 2.4 W
(peak @ 5 VDC)
Recovery time after defibrillator test Unaffected
Water handling Nomoline Family sampling lines with proprietary water
removal tubing.
Sampling flow rate 50 ±10 ml/min
2. Data output

Breath detection Adaptive threshold, minimum 1 vol% change in CO2

concentration.
Respiration rate 0 to 150 ±1 breaths/min
Fi and ET 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:
CO2
CO2 ET=ETnom×(125RR⁄) for RRth >125
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 OR+/AX+: Primary and secondary agent.

3. Gas Analyzer

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 CO2: Automatic compensation for pressure and
temperature. Manual compensation for broadening effects
on CO2.
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 CO2: < 10 seconds (Concentrations reported and full
accuracy)
OR+/AX+: < 20 seconds (Concentrations reported,
automatic agent identification enabled and full accuracy)
Rise time(10% to 90%) CO2 ≤ 200 ms (ISA OR+/AX+ : ≤ 250 ms) ;
N2O ≤ 350 ms;
ENF, ISO, SEV, DES, HAL ≤ 350 ms;

15-10
 O2 ≤ 450 ms;

Primary agent threshold (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
(OR+/AX+)
Agent identification time (OR+/AX+) < 20 seconds (typically < 10 seconds)
Total system response time CO2
< 3 seconds
OR+/AX+
< 4 seconds
(with 2 m Nomoline Airway Adapter Set sampling line)

4. Gas

The accuracy of all detected values meet the requirements of ISO 80601-2-55 and EN 864:1996.

Accuracy for standard conditions The following accuracy apply to a dry gas at 22±5°C and 1013±40hPa.

1) Accuracy –standard conditions(the range and accuracy of masimo AG as follow)

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
0 to 10 vol% ±(0.15 vol%+5%of reading)
SEV
10 to 25 vol% Not specified
0 to 22 vol% ±(0.15 vol%+5%of reading)
DES
22 to 25 vol% Not specified
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)
Agents ±(0.2 kPa + 10% of reading)
O2 ±(2 kPa + 2% of reading)

15-11
Total system response time: CO2 ＜ 3s OR+/AX+ ＜4s

Breath detection: adaptive threshold value, minimum CO2 concentration change is 1vol%

Breath frequency: 0-150 times/minute

Threshold value of Anesthetic gases: main Anesthetic gas (OR+/AX+):0.15 vol% When an Anesthetic gas
is marked, its concentration will be reported even if it is below 0.15 vol%.

5. Impact of interfering gases and water vapor

Carbon dioxide Anesthetic nitrogen

Gases or water vapor Gas concentration
Carbon dioxide AX+ gas monoxide
nitrogen monoxide 4) 60 vol% _2) _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 15 vol%
reading 3)
Xe(xenon) 80 vol% -10% of the reading 3) _1) _1)
He(helium) 50 vol% -6% of the reading 3) _1) _1)
Quantitative spray Quantitative spray
C2H50H(ethanol) 0.3 VOI% _1) _1) _1) _1)
C3H70H(isopropanol) 0.5 VOI% _1) _1) _1) _1)
CH3COCH3(acetone) 1 vol% _1) _1) _1) _1)
CH4(methane) 3 vol% _1) _1) _1) _1)
CO(carbon monoxide) 1 vol% _1) _1) _1) _1)

CO(nitric oxide) 0.02 vol% _1) _1) _1) _1)

Oxygen 100 vol% _2) _2) _2) _2)

Note 1: The abovementioned “Accuracy – all conditions” includes all negligible interferences and impacts.

Note 2: The abovementioned “Accuracy – 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 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.

15-12
15.5.2 MASIMO（CO2）Mainstream Analyzer Specifications

Name Specifications
EtCO2 complies with the requirements of standard YY0601
EtCO2 specification of Masimo (Mainstream)
CO2
measurement 0mmHg~190mmHg,0~25%(at760mmHg)
range
CO2 resolution 1mmHg or 0.1kPa or 0.1%
All conditions：
CO2 accuracy
±(0.3kPa+4% of the readings)
Total system
<1s
response time
Respiration rate 0~150rpm
Whether there is
automatic
barometric Configuration
pressure
compensation
Warm up time 10s

15.5.3 EtCO2 specification of Respironics

EtCO2 specification of Respironics (Mainstream) EtCO2 specification of Respironics (Sidestream)

CO2 0~150 mmHg 0~150 mmHg
measurement 0%～19.7% 0%～19.7%
range 0~20.0kPa (at760 mmHg) 0~20.0kPa (at760 mmHg)
CO2 resolution 1mmHg or 0.1kPa or 0.1% 1mmHg or 0.1kPa or 0.1%

Should be ±0.3% at 0%～5.3%;

Should be ±5% of the reading at Should be ±0.3% at 0%～5.3%;
5.4%～9.2%; Should be ±5% of the reading at 5.4%～9.2%;
CO2 accuracy
Should be ±8% of the reading at Should be ±8% of the reading at 9.3%～13.2%;
9.3%～13.2%; Should be ±10% of the reading at 13.3%～19.7%;
Should be ±10% of the reading at

15-13
 13.3%～19.7%;
Sampling flow
/ 50±10 ml/min
velocity
Sampling Rate 100Hz 100Hz
Method: Peak of the expired CO2 LoFlo sidestream:Method: Peak of the expired
waveform CO2 waveform
Selections: 1 breath, 10 second, Selections: 1 breath, 10 second, 20 second
ETCO2 20 second CapnoTrak sidestream: Range: 0, 5 to 99 mmHg
Calculation Note: the minimum reported Method: Peak of the expired CO2 waveform over
differential value between the selected time period. Minimum of 5 mmHg
baseline and the between peak and valley of waveform required.
CO2 value shall be 5 mmHg. Time Period Selections: 10 second, 20 second
CapnoTrak sidestream:ETCO2 and Respiration
Rate accuracy is verified by using a solenoid test
setup to deliver a square wave of known CO2
concentration to the device. 5% and 10% CO2
ETCO2 and concentrations were used and respiration rate was
Respiration rate / varied over the range of the device. Pass/Fail
accuracy method criteria was a comparison of the respiratory rate
output from the sensor to the frequency of the
square wave. EtCO2 measurements at those rates
were compared to the CO2 readings under static
flow conditions.
CapnoTrak sidestream:Range: 0, 2 to 100 breaths
Range: 0 to 150 breaths per minute
Respiration Rate per minute (br/m)
(BPM)
Calculation Accuracy: ±1 breath per minute
Accuracy: ±1 breath
Method: 8 breath averaging
LoFlo sidestream: <4seconds - includes transport
time and rise time(Typical rise time:250ms)
CapnoTrak sidestream:Less than 4 seconds.
Total system Includes transport time and rise time with water
<1s
response time filter assembly and airway adapter.(Up to an
additional 3 seconds for sidestream sampling
cannulas with dehumidification and extension
tubing)
CO2 Rise Time / CapnoTrak sidestream:Less than 340ms.(Up to

15-14
 an additional 70ms for sidestream sampling
cannulas with dehumidification and extension
tubing)
Warm up time 2min /
Whether there is
automatic
barometric None /
pressure
compensation

15.5.4 Artema AG gas analysis Specification

Gas Range Accuracy

0 to 1vol% ±0.15 vol %

SEV 1 to 5vol% ±0.2 vol %

5 to 8vol% ±0.4 vol %

0 to 1 vol% ±0.15 vol %

1 to 5 vol% ±0.2 vol %

DES 5 to 10 vol% ±0.4 vol %

10 to 15 vol% ±0.6 vol %

15 to 18 vol% ±1 vol %

0 to 1 vol% ±0.15 vol %

HAL/ISO/ENF
1 to 5 vol% ±0.2 vol %

0 to 20 vol% ±2 vol %
N2O
20 to 100 vol% ±3 vol %

0 to 25 vol% ±1 vol %

O2 25 to 80 vol% ±2 vol %

80 to 100 vol% ±3 vol %

0 to 1 vol% ±0.1 vol %

CO2 1 to 5 vol% ±0.2 vol %

5 to 7 vol% ±0.3 vol %

15-15
 7 to 10 vol% ±0.5 vol %

15.6 BIS module specifications

15.6.1 BIS module specifications

Name Specification

BIS：0.0~100.0

BIS measurement range SQI：0.0~100.0%

and accuracy EMG：0~100dB

ESR:0.0~100.0%

15.7 EMC and Radio Management Compliance

Anesthesia machine AX-600,AX-700,AX-700A and AX-800 conform to EMC Standard IEC 60601-1-2.

Caution
 Anesthesia machines AX-600,AX-700,AX-700A and AX-800 meet the requirement of
electromagnetic compatibility in IEC60601-1-2.
 The user needs to install and use according to electromagnetism compatibility information
which is attached with it.
 Portable and mobile RF communication devices may influence Anesthesia machines
AX-600,AX-700,AX-700A and AX-800 performance, so Anesthesia machines AX-600,AX-700,AX-700A
and AX-800 should be kept away from them during using.
 Guidance and manufacturer’s declaration stated in the appendix.

Warning
 Anesthesia machines AX-600,AX-700,AX-700A and AX-800 should not be used adjacent to
or stacked with other equipment and that if adjacent or stacked use is necessary, the Anesthesia
machines AX-600,AX-700,AX-700A and AX-800 should be observed to verify normal operation in the
configuration in which it will be used.
 When the plug-in slot is plugged into any one of the three modules, Masimo CO2
(mainstream), Respironics CO2 (mainstream) and BIS, EMC is of Class A. When the plug-in slot is not

15-16
plugged into these three modules, EMC is of Class B.
Table 1
Guidance and manufacturer’s declaration –electromagnetic emissions
The Anesthesia machines AX-600,AX-700,AX-700A and AX-800 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 Anesthesia machines AX-600,AX-700,AX-700A and
CISPR 11 AX-800 uses RF energy only for its internal function.
Group 1 Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
RF emissions The Anesthesia machines AX-600,AX-700,AX-700A and
Class B
CISPR 11 AX-800 is suitable for use in all establishments other than
Harmonic emissions domestic and those directly connected to the public
Class A
IEC 61000-3-2 low-voltage power supply network that supplies buildings
Voltage fluctuations / used for domestic purposes.
flicker emissions Complies
IEC 61000-3-3

Table 2
Guidance and manufacturer’s declaration – electromagnetic immunity
The Anesthesia machines AX-600,AX-700,AX-700A and AX-800 is intended for use in the electromagnetic
environment specified below.
The customer or the user of the Anesthesia machines AX-600,AX-700,AX-700A and AX-800 should assure
that it is used in such an environment.
IEC 60601 test Electromagnetic
Immunity test Compliance level
level environment –guidance
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood,
discharge (ESD) ±2,4,8,15 kV air ±2,4,8,15 kV air concrete or ceramic tile. If
floors are covered with
IEC 61000-4-2 synthetic material, the
relative humidity should be
at least 30 %.

15-17
Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality should
transient/burst supply lines supply lines be that of a typical
IEC 61000-4-4 ± 1 kV for ± 1 kV for commercial or hospital
input/output lines input/output lines environment.
100 kHz repetition 100 kHz repetition
frequency frequency
Surge ± 0.5kV, ± 1 kV ± 0.5kV, ± 1 kV Mains power quality should
line(s) to lines line(s) to lines be that of a typical
IEC 61000-4-5 ± 0.5kV, ± 1 kV, ± ± 0.5kV, ± 1 kV, ± 2 commercial or hospital
2 kV line(s) to kV line(s) to earth environment.
earth
Voltage dips, short 0 % UT; 0.5 cycle 0 % UT; 0.5 cycle Mains power quality should
At 0°, 45°, 90°, At 0°, 45°, 90°,
interruptions and be that of a typical
135°, 180°, 225°, 135°, 180°, 225°,
voltage variations 270°and 315° 270°and 315° commercial or hospital
on power supply environment. If the user of
0 % UT; 1 cycle 0 % UT; 1 cycle
input lines the Anesthesia machines
and and
70 % UT; 25/30 70 % UT; 25/30 AX-600,AX-700,AX-700A
IEC 61000-4-11 cycles cycles and AX-800 requires
Single phase: at 0° Single phase: at 0° continued operation during
power mains interruptions, it
0 % UT; 250/300 0 % UT; 250/300
cycles is recommended that the
cycles
Anesthesia machines
AX-600,AX-700,AX-700A
and AX-800 be powered
from an uninterruptible
power supply or a battery.
Power frequency magnetic
Power frequency 30 A/m(50/60 Hz) 30 A/m
fields

magnetic field should be at levels

characteristic of a typical

IEC 61000-4-8 location in a typical

commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

Table 3

Guidance and manufacturer’s declaration – electromagnetic immunity

15-18
The Anesthesia machines AX-600,AX-700,AX-700A and AX-800 is intended for use in the
electromagnetic environment specified below.
The customer or the user of the Anesthesia machines AX-600,AX-700,AX-700A and AX-800 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
Anesthesia machines
AX-600,AX-700,AX-700A and
AX-800, including cables, than the
recommended separation distance
Conducted RF 3Vrms (emf), 3Vrms (emf), calculated from the equation
IEC 61000-4-6 6Vrms (emf) in 6Vrms (emf) applicable to the frequency of the
ISM and amateur in ISM and transmitter.
Radiated RF radio bands amateur radio Recommended separation distance
IEC 61000-4-3 150kHz to 80MHz bands
d = 1.2 P

3V/m 3V/m d = 1.2 P 80MHz to 800MHz

80MHz to 2.7GHz
d = 2.3 P 800MHz to 2.7GHz

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, ashould
be less than the compliance level in
each frequency range. b
Interference may occur in the vicinity
of equipment marked with the
following symbol:

15-19
 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.
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 VT 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
Anesthesia machines AX-600,AX-700,AX-700A and AX-800 is used exceeds the applicable RF
compliance level above, the Anesthesia machines AX-600,AX-700,AX-700A and AX-800 should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Anesthesia machines AX-600,AX-700,AX-700A and
AX-800.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.

Recommended separation distances between

portable and mobile RF communications equipment and the AX-600,AX-700,AX-700A and AX-800.
The AX-600,AX-700,AX-700A and AX-800 is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the AX-600,AX-700,AX-700A and
AX-800 can help prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the AX-600,AX-700,AX-700A and AX-800 as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter
power of transmitter (m)
(W)
150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the

15-20
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for 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.

declaration - IMMUNITY to proximity fields from RF wireless communications equipment

AX-600,AX-700,AX-700A and AX-800 is intended for use in an electromagnetic environment in which RF
wireless communications equipment are controlled.
Immunity IEC60601 test level Complianc Electromagnetic
test e level environment -
Test Modulation Maximu Immunity
guidance
frequency m level
power
Radiated 385 MHz **Pulse 1.8W 27 V/m 27 V/m
RF Modulation:
IEC 18Hz
61000-4-3 450 MHz *FM+ 5Hz 2W 28 V/m 28 V/m
deviation:
1kHz sine
710 MHz **Pulse 0.2 W 9 V/m 9 V/m
745 MHz Modulation:
780 MHz 217Hz
810 MHz **Pulse 2W 28 V/m 28 V/m
870 MHz Modulation:
930 MHz 18Hz
1720 MHz **Pulse 2W 28 V/m 28 V/m
1845 MHz Modulation:
1970 MHz 217Hz
2450 MHz **Pulse 2W 28 V/m 28 V/m
Modulation:
217Hz
5240 MHz **Pulse 0.2 W 9 V/m 9 V/m
5500 MHz Modulation:
5785 MHz 217Hz

Note * - As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it

does not represent actual modulation, it would be worst case.
Note** - The carrier shall be modulated using a 50 % duty cycle square wave signal.

15.8 Physical Specifications

15-21
Dimensions of the Complete Machine

Size 689mm*800mm*1400mm

Weight 125 kg (standard configuration) (without Anesthesia vaporizer and gas cylinder)

Maximum Bearing Weight The maximum bearing weight of the entire machine is 210 kg

Top Plate

Maximum Bearing Weight Maximum load-bearing of top plate is 20 kg

Operational dimensions 508 mm*313 mm

Dimensions with
508 mm*313 mm*380 mm
Additional Accessory

Workbench

Maximum supporting
Maximum supporting weight of workbench is 20 kg
weight

Operational dimensions 472 mm*248 mm

Dimension with
472 mm*248 mm*380 mm
Additional Accessory

Dovetail Rail

Maximum Installation
500 mm*750 mm*500 mm
Dimension

Handrail

Length 750 mm

Drawers

Top: 1 kg
Maximum Bearing Weight
Bottom: 3 kg

Top: 462 mm*287 mm*141 mm

Drawers
Bottom: 437 mm*287 mm*245 mm

Gas-bag Sway Brace

Length: 425 mm
Size
Height: 240 mm

Loop Hook

15-22
Maximum Bearing Weight
1 kg
of Loop Hook

Caster Wheels

Caster wheel 5 inch

Display Screen

Type TFT LCD, allowing touch control

AX-600, AX-700,AX-700A:12.1 inch

Size
AX-800：15 inch

Resolution AX-600, AX-700,AX-700A:800*600 pixels; AX-800: 1024*768 pixels

Brightness Adjustable

LED Indication

AC indicator lamp Green LED

It is on when the equipment is connected to external AC power supply.

Battery indicator lamp Green LED

Battery indicator lamp is constantly on while the equipment is connected to AC

power supply.
When the system is powered by battery, battery indicator lamp flashes as per a
frequency of 1 Hz.

Working state indicator Green LED

lamp The indicator lamp is on when the equipment is turned on.
The indicator lamp is off when the equipment is turned off.

1 piece (yellow, red. It only flashes in red when high-level and medium-level
Alarm indicator lamp
alarms occurs simultaneously)

Audible Indication

It gives out alarm tone and key-stoke 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.

Connector

1 AC power supply connector

Power supply
4 auxiliary output power-supply connectors

Equal-potential 1 equal-potential grounding terminal

15-23
 1 RJ45 connector
Communication
1 USB connector
connectors
1 DB9 connector

15.9 Environmental Specifications

Host

Relative humidity
Item Temperature (ºC) Atmospheric pressure (kPa)
(Non-condensation)

Work 10~40 ≤93% 70.0~106.0

Transportation and –20~60 (oxygen sensor:

≤93% 50.0~106.0
storage –20~50)

15.10 Performance Specifications

15.10.1 Gas Circuit Specifications

Gas Supply
Pipeline gasses O2,N2O,AIR
Backup gas-cylinder gasses O2,N2O,AIR
Pipeline gas connection NIST
Backup cylinder connection YOKE-CGA
Pressure range at inlet 280~600 kPa
Filter 60-80um

15.10.2 Gas Supply

Electronic Flowmeter

Air range 0~10 L/Min,the flow can be adjusted to 50ml/min

Display range and accuracy O2 range 0~10 L/Min,the flow can be adjusted to 50ml/min
N2O range 0~10 L/Min,the flow can be adjusted to 50ml/min
Summation Flowmeter
Display range Type Float flowmeter

15-24
 Range 0~15 L/Min

Tube Flowmeter

Air range 0~10 L/Min,the flow can be adjusted to 50ml/min

Display range and accuracy O2 range 0~10 L/Min,the flow can be adjusted to 50ml/min
N2O range 0~10 L/Min,the flow can be adjusted to 50ml/min
Auxiliary Oxygen Supply Flowmeter
Type Float flowmeter
Display range
Range 0~15 L/Min

Oxygen/N2O linked system

Type Mechanical type proportional control device

Range O2 concentration shall not be lower than 25%

15.10.3 ACGO Connector

ACGO

Connector Taper coaxial fitting of 22 mm (outside) and 15 (inside)

Back pressure generated at the

rear end of Anesthesia
Not greater than 2 kPa
Vaporizer and the front-end of
ACGO during oxygen flush

15.10.4 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.

15.10.5 Breathing System Specifications

Leakage and Compliance

Leak in breathing system and

its cycle absorption assembly The leakage shall not be greater than 65 ml/min at 3 kPa.
(including

15-25
Manual/spontaneous mode and
mechanical control mode)

Compliance of breathing
system and its cycle
Adult mode ≤4 mL/100 Pa, pediatric mode ≤3 mL/100 Pa
absorption assembly
(manual/spontaneous mode)

Leak in CO2 canister The leakage shall not be greater than 50ml/min at 3kPa.

The leakage shall not be greater than 50ml/min at 3kPa (APL valve scale
APL valve leak
mark is 75)
CO2 Absorption Apparatus
Volume of CO2 absorption
Approximately 2000ml
apparatus

Breathing Circuit Heat

The breathing circuit is equipped with heating function,which can effectively remove water accumulation in
the circuit.

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)

Manual bag end Taper coaxial fitting of 22mm (outside) and 15 (inside)

Pressure gauge (airway)

Range -20~100 cmH2O

Accuracy ±(4% of full scale reading ＋ 4% of actual reading)

APL Valve

Range 1~75 cmH2O

Touch indication Great than 30 cmH2O

Minimum opening pressure 0.3 cmH2O (dry), 0.5 cmH2O (humid)

The expiratory pressure/flow rate characteristics at a fresh gas flow rate of

10±1 L/min, or the maximum fresh-gas inlet flow rate specified in the
Expiratory impedance instructions for use (whichever is greater) of the Anesthetic breathing
system,including the flow at 15L/min, 30L/min, 60L/min,the expiratory
impedance of the breathing system should not exceed 0.6 KPa.

The inspiratory pressure/flow rate characteristics at a fresh gas flow rate of

Inspiratory impedance
10±1 L/min, or the maximum fresh-gas inlet flow rate specified in the

15-26
 instructions for use (whichever is greater) of the Anesthetic breathing
system,including the flow at 15L/min, 30L/min, 60L/min,the Inspiratory
impedance of the breathing system should not exceed 0.6 KPa.

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 canister is filled up with
“Medisord TM” CO2 absorbent)

Inspiratory impedance of breathing system cycle absorption assembly (CO2 canister is filled up with
“Medisord TM” CO2 absorbent)

15-27
15.11 Principle and Parameter Specifications of the Ventilator

15.11.1 Principle

The principle of this ventilator is pneumatically controlled.

Pneumatic devices of Ventilator is fitted inside the workbench of anesthesia machine.
Anesthesia machine can control the gasses flowing from electromagnetic 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
measures the change in pressure of gas flow that passes through the flow sensors, while
pressure varies along with the flow.

Ventilator uses 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.

15-28
15.11.2 Parameter Specifications

Parameter Setting Range of Ventilatior

Parameter Setting range Step Working mode

VCV,SIMV-VC,PCV,SIM
Plimit (Pressure limit) 10~100 cmH2O 1 cmH2O V-PC,CPAP/PSV,PRVC,PS
VPro,SIMV- PRVC

Pinsp (Inspiratory pressure) 5~70 cmH2O 1 cmH2O PCV,SIMV-PC,PSVPro

SIMV-PC,SIMV-VC,CPAP
ΔPps(Support Pressure) 3~60 cmH2O 1 cmH2O /PSV,PSVPro,SIMV-
PRVC

Apnea Pressure 3～60cmH2O 1 cmH2O CPAP/PSV

VCV,SIMV-VC,PCV,SIM
PEEP (Positive
OFF, 3~30 cmH2O 1 cmH2O V-PC,CPAP/PSV,PRVC,PS
end-expiratory pressure)
VPro,SIMV- PRVC
15mL~1500mL(VCV,
SIMV-VC,SIMV-PC,
CPAP/PSV,PRVC,SI 15~100 ml: 5 ml
MV-PRVC,PSVPro）; VCV,SIMV-VC,PRVC,
VT (Tidal volume) 100~300 ml: 10 ml
In the PCV mode,tidal SIMV- PRVC
300~1500 ml: 25 ml
volume can be
detected to 5ml.

VCV,SIMV-VC,PCV,SIM
Rate(Respiratory Rate) 4~100 bpm 1 bpm V-PC,PRVC,PSVPro,SIM
V- PRVC

I:E (Inspiratory expiratory

4:1~1:10 0.5 VCV, PCV ,PRVC
time ratio)
Apnea.IE(Apnea 4：1～1：8
0.5 CPAP/PSV
Respiratory Ratio)
OFF, 5%~60% of
Tpause (Inspiratory Pause) 1% VCV, SIMV-VC
inhaling time

Trig window(Trigger SIMV-PC,SIMV-VC,

5%~90% 5%
window) PSVPro, SIMV-PRVC

15-29
 SIMV-VC,SIMV-PC ,SIM
Rate (SIMV Frequency) 4~60 BPM 1 BPM
V- PRVC

Apnea Time 10s～30s 1s PSVPro

Exp%(Inspiratory Stop 5%～80% SIMV-VC,SIMV-PC,

level) 1% CPAP/PSV,PSVPro,SIMV-
PRVC

Minrate 2～60bpm 1bpm CPAP/PSV

SIMV-VC,SIMV-PC,PSVP
Tinsp (Inspiratory time) 0.2~5.0 s 0.1 s
ro,SIMV- PRVC

Pressure triggering: Pressure triggering:

SIMV-VC,SIMV-PC,CPAP
Trigger(Inspiratory -20cmH2O~-1 cmH2O -0.5cmH2O
/PSV,PSVPro,SIMV-
triggering) Flow rate triggering: Flow rate triggering:
PRVC
0.2~15 L/min 0.1 L/min

Tslope (Pressure slope) 0 s～2.0 s PCV,CPAP/PSV,PSVPrO,S

0.1s IMV-VC,SIMV-PC,SIMV-
PRVC

Performance of Ventilator

Driving pressure 280~600 kPa

Maximum inspiratory flow shall not lower than 120L/min when gas supply
Inspiratory flow
pressure is 280 kPa.

Range of flow valve 1~120 L/min

Pressure limit controlling 1. Controlled by the electronic relief valve fitted inside the ventilator;
means for ventilator 2. Controlled by the mechanical relief valve fitted inside the ventilator.

Monitoring Parameters of Ventilator

MV(Per-minute
0~100 L/Min
ventilation amount)

VT(Inspiratory and
0~3000 mL
expiratory tidal volume)

FiO2(Oxygen
18~100%
concentration)

Paw (Airway pressure) -20~120 cmH2O

PEEP(Positive end 0 cmH2O～70 cmH2O

15-30
expiratory pressure)

Pmean(Mean pressure) -20~120 cmH2O

Pplat(Platform pressure) 0~120 cmH2O

I:E(Inspiratory- expiratory
4:1~1:12
ratio)

Rate(Respiratory rate) 0~120 bpm

Compl(Compliance) 0 ml/cmH2O～300 ml/cmH2O

Resistance 0 cmH2O/(L/s)～600 cmH2O/(L/s)

O2 concentration of
18%～100%；
oxygen sensor

Main flow control system Monitoring range: 0 L/min ～10 L/min；

Flow control system Monitoring range: 0 L/min ～ 15

Auxiliary gas flow control
L/min；
system

a) BIS:0.0～100.0
Depth of anesthesia
b) SQI:0.0～100.0%
testing and
c) EMG:0～100dB
measurement
d) ESR:0.0～100.0%

Monitoring Parameters of Positive end-expiratory Pressure PEEP

Range 0~70 cmH2O

15.11.3 Accuracy of Ventilator

Parameters
15 mL～60 mL：±10 mL；
VT 60 mL～210 mL（except 60 mL）：±15 mL；
210 mL～1500 mL (except 210 mL): ±7% of set value.

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 Inspiratory pressure: ±2.5 cmH2O or ±7% of setting value, whichever is greater;
Limit pressure: ±2.5 cmH2O or ±7% of setting value, whichever is greater;
End-expiratory positive pressure: the error is not defined at the OFF state
PCV 3 cmH2O～30 cmH2O: ±2.0 cmH2O or ±8% of setting value, whichever is greater;
Support pressure: ±2.5 cmH2O or ±7% of setting value, whichever is greater;
Apnea pressure: ±2.5 cmH2O or ±7% of setting value, whichever is greater;
Trigger pressure: ±2 cmH2O

Rate ±1 bpm or ±5% of the setting value, whichever is greater.

I:E: 2：1～1：4：±10% of actual reading

I:E and Other scope: ±25% of actual reading。

Apnea.IE Apnea.IE: Error within the range of 2：1～1：4: ±10% of the setting value,
Other range: ±25% of the setting value
Inspiratory time: ±0.2 s；
Tpause Inspiratory pause: ±15% of the set value in the range of 20% to 60%, not defined in other
ranges. ;

Trigger window ±10%

Trigger flow
±1 L/min
rate

Inspiratory Stop
±10%
level

When the full scale is between 10% and 100%, the accuracy of the
Main flow control
scale should be within ± 10% of the indicated value, and the other
system
Flow control ranges are not defined.
system Auxiliary gas When the full scale is between 10% and 100%, the accuracy of the
flow control scale should be within ± 10% of the indicated value, and the other
system ranges are not defined.
Measurement Parameters
0～60ml(excluding 60ml): ：±10 ml；
VTexp 60ml ~ 3000ml: ± 20ml or ± 7% of the actual reading, whichever is greater, the other
ranges are not defined.
Inspiratory tidal ± 20ml or ± 7% of the actual reading, whichever is greater, the other ranges are not
volume defined.

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 Pressure monitoring error: -20 cmH2O～120 cmH2O: ±2.0 cmH2O or ± 4% of setting
value, whichever is greater; the other ranges are not defined.
End-expiratory positive pressure error: 0 cmH2O～70 cmH2O: ±2.0 cmH2O or ± 4% of
setting value, whichever is greater; the other ranges are not defined.
Paw
Platform monitoring error: 0 cmH2O～120 cmH2O: ±2.0 cmH2O or ±4% of setting value,
whichever is greater; the other ranges are not defined.
Average pressure monitoring error: -20 cmH2O～120 cmH2O: ±2.0 cmH2O or ± 4% of
setting value, whichever is greater; the other ranges are not defined.

Rate ±1 bpm or ±5% of the setting value, whichever is greater; the other ranges are not defined.

2：1～1：4：±10% of actual reading

I:E 4：1～2：1 and 1：4～1：12 ±25% of actual reading
Other ranges are not defined.
0 L/min～30 L/min: ±1 L/min or ±15% of the setting value, whichever is greater; >30
MV
L/min: not defined.
0 ml/cmH2O～250 ml/cmH2O: ±0.5 ml/cmH2O or ±15% of the actual reading, whichever
Compl
is greater, the other ranges are not defined.
0 cmH2O/(L/s) ～ 20 cmH2O/(L/s) ： ± 10 cmH2O/(L/s) ； 20 cmH2O/(L/s) ～ 500
Resistance
cmH2O/(L/s)：±50% of the actual reading;the other ranges are not defined.
When the full scale is between 10% and 100%, the accuracy of the
Main flow control
scale should be within ± 10% of the indicated value, and the other
Flow control system
ranges are not defined.
system
Auxiliary gas flow When the full scale is between 10% and 100%, it should be within
control system ±10% of the indicated value, and the other ranges are not defined.

O2 concentration
of oxygen ±3%（V/V），the other ranges are not defined.
sensor

Alarm Setting
Parameter Setting range Remarks

High Limit 5~1600 mL High Limit is greater than

VT
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 Limit -2) % low limit

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EtCO2 Alarm High alarm limit Low limit +2mmHg～150mmHg
Preset
Low alarm limit 0mmHg～High limit -2mmHg
(Respironics High limit is greater than
CO2)
low limit

FiCO2 Alarm High alarm limit Low limit +1mmHg～76mmHg

Preset
Low alarm limit 0mmHg~74mmHg High limit is greater than
(Respironics
CO2) low limit

EtCO2 Alarm High alarm limit Low limit +2mmHg～190mmHg

Preset
Low alarm limit 0mmHg～High limit -2mmHg High limit is greater than
(Masimo
CO2) low limit

FiCO2 Alarm High alarm limit Low limit +1mmHg～99mmHg

Preset
Low alarm limit 0mmHg~97mmHg High limit is greater than
(Masimo
CO2) 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 airway pressure is lower than -10cmH2O.
Asphyxiation 20 s, with error of ±3 s
alarm time
BIS alarm BIS alarm limit: 0～100
Resolution: 1
limit
Alarm preset limit: High: 2～100,Lower: 0～98
Alarm mute 120s
The anesthesia system will provide a notification of a high priority alarm when the pressure of the anesthetic
ventilation system exceeds the set continuous positive pressure alarm limit by (15 + 1) s.
AG alarm range and resolution
Parameter Set range Remark
EtCO2 High (Low limit +2mmHg)～190mmHg High limit greater
alarm than Low limit
limit

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 Low 0mmHg～(High limit -2mmHg)
alarm
limit
FiCO2 High (Low limit +2mmHg)～99mmHg High limit greater
alarm than Low limit
limit
Low 0mmHg～(High limit -2mmHg)
alarm
limit
EtN2O High (Low limit + 2%) ～100 % High limit greater
alarm than Low limit
limit
Low 0％～(High limit - 2%)
alarm
limit
FiN2O High (Low limit + 2%) ～100% High limit greater
alarm than Low limit
limit
Low 0％～(High limit - 2%)
alarm
limit
EtHAL/EtEN High (Low limit +0.2%) ～25.0% High limit greater
F/EtISO/EtS alarm than Low limit
EV/EtDES limit
Low 0％～(High limit - 0.2%)
alarm
limit
FiHAL/FiEN High (Low limit +0.2%) ～25.0% High limit greater
F/FiISO/FiSE alarm than Low limit
V/FiDES limit
Low 0％～(High limit - 0.2%)
alarm
limit
Note: * Typical conditions for accuracy measure:

Atmospheric pressure: 90~101 kPa;

15-35
 Room temperature: 20 ~ 28 ºC;

Relative humidity: 50%~80%.

15.12 Principle and Specifications of Oxygen Sensors

15.12.1 Principle of Oxygen Sensor

Oxygen monitoring device may measure the oxygen concentration inside patient circuit.
Oxygen concentration measured by oxygen sensor is displayed in the display screen of
anesthesia machine.

Oxygen sensor is a type of electrochemical equipment. Oxygen penetrates into the battery
through a diaphragm and oxidizes 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.

15.12.2 Specifications of Oxygen Sensors

Oxygen sensor

Output Output 9-13 mV at 210 mBar O2

0.94 x 106 % O2 measurement time at 20°C

Expected operation life
0.6 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)

15-36
 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)

15.13 Specifications of AGSS Transfer and Receiving System

15.13.1 Physical parameters

Physical parameters of AGSS transfer and receiving system

Weight 2.2Kg
Dimension 535×120×155mm（H×W×T）
Applicable laws and ISO 80601-2-13 and YY 0635-2
regulations
Pressure relief device Atmospheric pressure compensation port

Filter Stainless steel mesh, with pore size of 60μm ~ 100μm

AGSS-H: The float drops below the "MIN" mark on the viewing window
when the system is not operating or when the suction flow rate is less than
50 L / min.
System status indication
AGSS-L: The float drops below the "MIN" mark on the viewing window
when the system is not operating or when the suction flow rate is less than
25 L / min.

System connector ISO 9170-2 or BS 6834 standard connector

15.13.2 Performance Parameter

Model
AGSS-H AGSS-L
Parameter
1H-type high-flow system: 1L low-flow system: drawing
Applicable for treatment system types drawing flow rate not less flow rate 25 ~ 50L / min
than 75L / min

15-37
Adjustable rated suction flow range 50L/min～80L/min 25L/min～50L/min
Observation window scale display MIN tick mark, MAX tick mark
Way of working Continue to draw the flow, the float between the MIN and MAX
tick marks
Working mode Continuous working system,to transfer and receive
30L / min intake flow No more than 0.5cmH2O
impedance
75L / min intake flow No more than 3.5cmH2O
Under impedance
norma Induced flow Not more than 50ml / min
l Rated maximum suction flow AGSS air outlet no lower than 10cmH2O
condit pressure drop impedance
ions Rated minimum suction flow AGSS air outlet no lower than 20cmH2O
pressure drop impedance
Overflow Not more than 100ml / min
Leakage Under inlet air condition of 10 ±0.5L / min , less than 90ml / min
75L / min intake flow
Under No more than 10cmH2O
impedance
single
Induced flow Not more than 100ml / min
failure
Rated maximum suction flow AGSS air outlet pressure drop resistance no greater than
condit
pressure drop impedance 0.5cmH2O
ion
Overflow May exceed 100ml/min

15.14 Vacuum suction system specifications

15.14.1 External vacuum suction system specifications

Please refer to the user manual supplied with the external vacuum suction system for the specifications
of the external vacuum suction system.
Vacuum suction system

The performance category high vacuum/high flow

Air source pressure range 280-550kPa
Recommended maximum negative 75kPa
pressure

15-38
The largest suction tubing size Φ8 mm

15.15 Alarm Specifications

15.15.1 The Sound Pressure Alarm

Sound Pressure Alarm

Range of alarm sound pressure 45 dB-85 dB

Peak sound pressure of

82 dB
high-priority alarm

Peak sound pressure of

80 dB
medium-priority alarm

Peak sound pressure of

79 dB
low-priority alarm

15.15.2 Air Source Pressure Alarm

Air source Pressure Alarm

The range of air source 190-220kPa

pressure alarm

15.16 Anesthetic Vaporizer Specifications

For the using of Draeger anesthesia vaporizer, Please refer to the Draeger anesthesia vaporizer user
manual.

15-39
 Chapter16 Consideration for Environmentally
Conscious Design

16.1 Instructions for Minimizing Environmental Impact during

Normal Use
This part is compiled based on the requirements of Clause 4 Protection of Environment, 4.5.2 Instructions
for minimizing environmental impact during normal use of IEC 60601-1-9.
According to the requirements of this clause, manufacturer shall provide instructions for minimizing the
environmental impact of the ME equipment during normal use in the accompanying documents.
The instructions cover the following items (Table 1).

Table 1 The requirements of Clause 4.5.2 and Instructions provided by manufacturer

The requirements of Clause 4.5.2 Instructions provided by manufacturer
Try to keep the integrity of the non-disposable
1) Instructions on how to install the ME
packing material and put away the packing materials
EQUIPMENT in order to minimize the
for future use or put into the specified location where
ENVIRONMENTAL IMPACT during its complying with the rules and regulations of the Local

EXPECTED SERVICE LIFE; and the Hospital. Avoid overusing the cleaning
reagents and other substances. For the reusable
accessories, clean it with specified reagent and put
away, and for the disposable one, deal with it in a
collective way and put into the specified location
where complying with the rules and regulations of
the Local and the Hospital. If not specified, please
follow the rules and regulations of the Local and the
Hospital.
Use the specified accessories and cleaning and
2) Instructions on how to use and maintain the
disinfection reagent to avoid harm to the machine
ME EQUIPMENT in order to minimize the
and accessories and reduction of the service life. Use
ENVIRONMENTAL IMPACT during its the medical device strictly following the instruction

EXPECTED SERVICE LIFE; manual. And for maintaining the medical device,
always dilute according to the manufacturer‟s
instructions or use lowest possible concentration.
Never use bleach. Do not mix disinfecting solutions

16-1
 (such as bleach and ammonia) as this may result in
hazardous or poisonous gases or liquids. When there
is a need to maintain, please follow the Instruction
for Use or follow the rules and regulations of the
Hospital.
During normal use of this device, it will consume
3) Consumption during NORMAL USE (e.g.
electricity (alternate current and direct
energy, consumable materials/parts,
current-battery). The disposable electrode is also
disposables, water, gasses, consumed and shall be disposed following the rules.

chemicals/reagents etc.); For cleaning or disinfection for the cables and

machine, the water and ethanol or isopropanol will
be used and the waste liquid shall be thrown
following the rules.
During normal use, it is expected there will be some
4) Emissions during NORMAL USE (e.g.
consumption of the medical device. To avoid
WASTE water, WASTE consumable
unnecessary consumption such as acoustic energy,
materials, acoustic energy, heat, gasses, heat, gases, hazardous substances, etc, it‟s

vapours, particulates, HAZARDOUS recommended that on the premise of normal

operation, turn down the volume of alarm so that
SUBSTANCES and other WASTE);
much interference will not be exerted to the
environment. Also turn off the unused module in
time to reduce the unnecessary heat emission and
electricity consumption.
The battery is located on the back of the machine.
5) Information on the location within the ME
Capacitors may contain stored energy or may pose
EQUIPMENT of HAZARDOUS
other hazards, assembled on the PCB boards within
SUBSTANCES, radioactive sources and the device.

induced radioactive materials.

16.2 Information for End of Life Management

This part is compiled based on Clause 4 Protection of Environment, 4.5.3 Information for end of life
management of IEC 60601-1-9.
According to the requirements of this clause, the manufacturer shall provide the responsible organization
with information for the proper disposal of the ME equipment at End of Life (EOL). And the manufacturer
shall make available information to waste treatment facilities necessary for the environmentally responsible
management of end of life ME equipment.
The information shall contain the following items (Table 2).

16-2
Table 2 The requirements of Clause 4.5.3 and Instructions provided by manufacturer
The requirements of Clause 4.5.3 Instructions provided by manufacturer
1) The location of components and parts The battery is located on the back of the device.
within the ME equipment that contain stored Capacitors may contain stored energy or may
energy or pose other hazards that can result in pose other hazards, assembled on the PCB
an unacceptable risk to disassemblers or others boards within the device.
and methods for controlling such risks.
2) The identity and location of hazardous The battery is located on the back of the device.
substances requiring special handling and Capacitors may contain stored energy or may
treatment pose other hazards, assembled on the PCB
boards within the device.
3) Disassembly instructions sufficient for the For other hazards that may result in
safe removal of these hazardous substances unacceptable risk, the main concern is the
including radioactive sources and induced handling with battery: Risk of fire, explosion,
radioactive materials within the ME equipment. or burns. Do not crush, puncture, disassemble
or short circuit the battery. Do not dispose of
the battery in fire or water. Do not place the
battery in an environment whose temperature is
above 60℃ （140℉）. Store the battery in the
-20℃（-4℉）to 60℃(140℉) environment. Use
the specified charger only. Read instructions for
use. Maximum Recommended Ambient is 45℃
(125℉).
Dispose of used batteries promptly and in an
environmentally-responsible manner. Do not
dispose of the battery in normal waste
containers. Consult your hospital administrator
to find out about local arrangements.
As for disposing of the medical device, to avoid
contaminating or infecting personnel, the
environment or other equipment, make sure you
disinfect and decontaminate the medical device
appropriately before disposing of it in
accordance with your country‟s laws for
equipment containing electrical and electronic
parts. For disposal of parts and accessories such
as thermometers, where not otherwise
specified, follow local regulations regarding

16-3
 disposal of hospital waste.

16-4