Operating Instructions for V3/V3A Ventilator

Copyright
Version: B00
No.: 046-00000135-00
Revision date: 2021/05
Product Name: Ventilator
Product Model: V3/V3A
Manufacturer: Shenzhen Comen Medical Instruments Co., Ltd.

Statement
All rights reserved by Shenzhen Comen Medical Instruments Co., Ltd.
This manual contains confidential information. No part of this manual may be reproduced, copied or
translated into other languages in any form without written permission of Comen.
This manual is only intended for users as a reference for operation, maintenance and repair of Comen product
V3/V3A. No one shall disclose the contents hereof to any other person.
Comen shall assume no liability for misuse of the information contained herein or any incidental or indirect
damages arising from improper operation or actual performance due to use of this manual. This Manual does
not imply the transfer of any proprietary right under patent law to any third party. Comen shall not be liable
for any legal consequences arising out of breach of the patent law or infringement of any third-party rights.
Please note that while every effort has been made to ensure that the data provided in this document are
accurate, the information, figures, illustrations, tables, specifications, and schematics contained herein, are
subject to change without prior notice.

Warranty
Comen will be responsible for the safety, reliability and performance of the product within the warranty
period, if all of the following conditions are satisfied:
 The product is used in accordance with this Manual.
 The product is installed, maintained or upgraded by approved or authorized personnel by Comen.
 The storage and operating environments for the product shall comply with the recommended information
and product specifications contained in this manual.
 The serial number label or manufacturing mark of the product is clearly legible.
 The damage is not caused by human factors.
 All replaceable components for maintaining, accessories, and consumables are originally supplied by
Comen or recognized by Comen.
Products conforming to Comen’s warranty service policy can enjoy free services; for products not covered by
the warranty scope, Comen will provide customer-paid services. If a product is transported to Comen for
repair, the transportation expense (including customs fees) should be on the customer’s account.

Repair Services
The warranty period of the product you purchased is subject to the relevant sales contract.
Consumables are consumable materials that should be replaced after each use or vulnerable materials that
require periodic replacement; consumables are not covered by the warranty.

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 Operating Instructions for V3/V3A Ventilator

The warranty period starts from the “Installation Date” shown on the Equipment Warranty Card provided
attached to the product. Equipment Warranty Card is the only proof to calculate the warranty period. To
protect your rights and interests, please fill in the Equipment Warranty Card after installation of the
equipment, and hand over the second copy of the ("Comen Retained" Copy) Equipment Warranty Card to
installer or send it back to the Customer Service Department of Shenzhen Comen Medical Instruments Co.,
Ltd.
Please note that the following circumstances will void the warranty:
1) The Equipment Warranty Card is not filled in and returned by the customer within 30 days after
installation and acceptance;
2) The equipment SN provided by the customer is incorrect (we confirm whether warranty service can
be provided based on the equipment SN).
You are entitled to our free after-sales services within the warranty period of the product; however, please
note that Shenzhen Comen Medical Instruments Co., Ltd. will only provide paid services and you are required
to pay the repair charges and part costs if the product requires repair for any of the following reasons:
 Man-made damage
 Improper use
 Grid voltage beyond the range specified for the product
 Failures caused by force majeure natural disaster
 Replacement with or use of any parts or accessories not accepted by Comen or repair by any person not
authorized by Comen
 Other failures not arising from the product itself
Any failure of the product caused by use of reagents or other consumables not accepted by Comen will not be
covered by the scope of repair services provided by Comen.
Upon expiration of the warranty period, Comen can continue to provide paid repair services.
If you do not pay or delay the payment for any charges of our paid repair services, Comen will suspend the
provision of repair services until you make the payment.

Return
If the products need to be returned to Comen, please contact Comen After-sales Service Department to
acquire the right to return the goods. You must provide product serial number, which can be found on the
product’s nameplate. If the serial number is illegible, your return request will be rejected. Please also present
the manufacture date and briefly describe the reason for return.

After-sales Service Provider

Name: After-sales Service Department of Shenzhen Comen Medical Instruments Co., Ltd.
Address: Floor 10 of Building 1A, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district,
Guangming District, Shenzhen
Tel.: 0086-755-26431236, 0086-755-86545386, 0086-755-26074134
Fax: 0086-755-26431232
Customer Service Hotline: 4007009488

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 Operating Instructions for V3/V3A Ventilator

Preface
This manual provides detailed descriptions of the performance, operation methods and other safety
information about V3/V3A ventilator. Please read carefully and understand the content of this manual so as to
ensure the safety of the patients and operator.
This manual introduces the product of the most complete configurations. Some configurations or functions
may not be available on the product you have purchased. If you have any questions, please contact us.
Please keep this manual near the device for easy and prompt access when needed.

Applicable object
The user manual is applicable for professional clinical medical staffs, qualified after training, or authorized
personnel.

Illustrations
All illustrations provided herein are for reference only. The menus, options, values and functions shown in the
illustrations may be not exactly identical to those shown on the product.

Conventions
 →: Represents operating steps.
 [Character]: Represents character strings in the software.
 Bold and italic: Represents chapters quoted.

Password
Password to enter the related settings of the ventilator:
 User maintenance: 5188

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Operating Instructions for V3/V3A Ventilator

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 Operating Instructions for V3/V3A ventilator

Contents
Chapter 1 Safety ............................................................................................................................................... 1-1
1.1 Safety Information .................................................................................................................................. 1-1
1.2 Contraindications.................................................................................................................................... 1-7
1.3 Equipment Symbols................................................................................................................................ 1-7
Chapter 2 Product Overview ............................................................................................................................ 2-1
2.1 Product Composition .............................................................................................................................. 2-1
2.2 Intended Use ........................................................................................................................................... 2-1
2.3 Product Appearance................................................................................................................................ 2-1
2.3.1 Overall Appearance ......................................................................................................................... 2-1
2.3.2 Main Unit Appearance .................................................................................................................... 2-3
2.3.2.1 Front View ................................................................................................................................ 2-3
2.3.2.2 Left View .................................................................................................................................. 2-4
2.3.2.3 Right View ................................................................................................................................ 2-5
2.3.2.4 Rear View ................................................................................................................................. 2-5
2.3.2.5 Bottom View ............................................................................................................................. 2-6
Chapter 3 Installation & Connection ................................................................................................................ 3-1
3.1 Unpacking and Checking ....................................................................................................................... 3-1
3.2 Environmental Requirements ................................................................................................................. 3-1
3.3 Install the Main Unit............................................................................................................................... 3-2
3.4 Connect to the Power Supply ................................................................................................................. 3-2
3.4.1 Connect to AC Power Supply.......................................................................................................... 3-2
3.4.2 Connect to DC Power Supply.......................................................................................................... 3-3
3.5 Connect to the Gas Supply ..................................................................................................................... 3-4
3.6 Install the Support Arm .......................................................................................................................... 3-5
3.7 Install the Patient Tubing........................................................................................................................ 3-7
3.8 Install the Humidifier ............................................................................................................................. 3-8
3.8.1 Install the Humidifier to the Ventilator ........................................................................................... 3-9
3.8.2 Install the Humidifier to the Ceiling Pendant ................................................................................ 3-10
3.9 Install the Nebulizer ............................................................................................................................. 3-11
3.9.1 Install Pneumatic Nebulizer........................................................................................................... 3-12
3.9.2 Install Electronic Nebulizer ........................................................................................................... 3-13
3.10 Install the Oxygen Sensor ................................................................................................................... 3-13
3.11 Install the Gas Cylinder ...................................................................................................................... 3-14
Chapter 4 Interfaces.......................................................................................................................................... 4-1
4.1 Main interface......................................................................................................................................... 4-1
4.2 Waveform Interface ................................................................................................................................ 4-3
4.3 Spirometry Interface ............................................................................................................................... 4-3
4.3.1 Set the Loop Type ........................................................................................................................... 4-4
4.3.2 Set the Reference Loop ................................................................................................................... 4-4
4.3.3 Reference Loop Review Interface ................................................................................................... 4-4
4.4 Measured Values Interface ..................................................................................................................... 4-5
4.5 BigNumeric Interface ............................................................................................................................. 4-5
4.5.1 Set display parameters ..................................................................................................................... 4-6
4.5.2 Setting the PulmoView .................................................................................................................... 4-6

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 Operating Instructions for V3/V3A Ventilator

4.6 Historical Data ........................................................................................................................................ 4-7

4.6.1 Icon Navigation ............................................................................................................................... 4-7
4.6.2 Graphic Trend.................................................................................................................................. 4-7
4.6.2.1 About Graphic Trend ................................................................................................................ 4-8
4.6.2.2 Interval...................................................................................................................................... 4-8
4.6.2.3 Display Group .......................................................................................................................... 4-8
4.6.3 Tabular Trend .................................................................................................................................. 4-8
4.6.3.1 About Tabular Trends ............................................................................................................... 4-9
4.6.3.2 Interval...................................................................................................................................... 4-9
4.6.3.3 Display Group .......................................................................................................................... 4-9
4.6.4 Setting Trends.................................................................................................................................. 4-9
4.6.4.1 About Setting Trends .............................................................................................................. 4-10
4.6.5 Event Logbook .............................................................................................................................. 4-10
4.6.5.1 About Event Logbook............................................................................................................. 4-11
4.6.5.2 Filter ....................................................................................................................................... 4-11
4.7 Freeze ................................................................................................................................................... 4-11
4.7.1 Enter Freeze State .......................................................................................................................... 4-12
4.7.2 Waveforms Review ....................................................................................................................... 4-12
4.7.3 View the Loop ............................................................................................................................... 4-12
4.7.4 Exit Freeze State ............................................................................................................................ 4-13
4.8 Lock Screen .......................................................................................................................................... 4-13
Chapter 5 Basic Operations .............................................................................................................................. 5-1
5.1 Display Setting ....................................................................................................................................... 5-1
5.1.1 Waveform Setting ............................................................................................................................ 5-1
5.1.2 Colors .............................................................................................................................................. 5-1
5.1.3 Defaults ........................................................................................................................................... 5-1
5.2 Set IBW/Height ...................................................................................................................................... 5-2
5.3 Set TV/IBW............................................................................................................................................ 5-2
5.4 Set Tinsp/ I:E .......................................................................................................................................... 5-2
5.5 Set DuoVent Time Parameter ................................................................................................................. 5-2
5.6 Set Invasive Apnea Mode ....................................................................................................................... 5-2
5.7 Set Oxygen Sensor Monitoring .............................................................................................................. 5-3
5.8 Set Language .......................................................................................................................................... 5-3
5.9 Set Unit ................................................................................................................................................... 5-3
5.10 Set O2 Supply Type .............................................................................................................................. 5-3
5.11 Set Screen Brightness ........................................................................................................................... 5-4
5.12 Set Key Volume ................................................................................................................................... 5-4
5.13 Set Time and Date ................................................................................................................................ 5-4
5.14 View System Information..................................................................................................................... 5-4
5.14.1 Version Information ...................................................................................................................... 5-4
5.14.2 Configuration Information ............................................................................................................. 5-4
5.14.3 Maintenance Information .............................................................................................................. 5-5
5.15 Manage Default Settings ...................................................................................................................... 5-5
5.15.1 Save and Load Current Settings .................................................................................................... 5-5
5.15.2 Restore Factory Default Settings ................................................................................................... 5-5
5.15.3 Restore the Latest Set Values ........................................................................................................ 5-5
5.16 Data Transfer ........................................................................................................................................ 5-6

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5.17 Data Export........................................................................................................................................... 5-6

5.17.1 Screen Export ................................................................................................................................ 5-6
5.17.2 Data Export.................................................................................................................................... 5-6
5.18 Power Failure Alarm ............................................................................................................................ 5-7
Chapter 6 Alarms.............................................................................................................................................. 6-1
6.1 Safety Precautions .................................................................................................................................. 6-1
6.2 Alarm Type............................................................................................................................................. 6-2
6.3 Alarm Level ............................................................................................................................................ 6-2
6.4 Alarm Mode ........................................................................................................................................... 6-2
6.4.1 Light Alarm ..................................................................................................................................... 6-2
6.4.2 Sound Alarm.................................................................................................................................... 6-3
6.4.3 Alarm Message ................................................................................................................................ 6-3
6.4.4 Alarm parameter form ..................................................................................................................... 6-3
6.4.5 Alarm State Icons ............................................................................................................................ 6-3
6.5 Set Alarm Limit of Parameters ............................................................................................................... 6-4
6.5.1 Set SpO2 Limit ................................................................................................................................. 6-5
6.5.2 Set Auto Alarm Limit ...................................................................................................................... 6-5
6.6 Set Alarm Volume .................................................................................................................................. 6-6
6.6.1 Set Minimum Alarm Volume .......................................................................................................... 6-6
6.6.2 Set Alarm Volume ........................................................................................................................... 6-6
6.7 Alarm Audio Paused............................................................................................................................... 6-6
6.8 Recent Alarm.......................................................................................................................................... 6-7
6.9 Alarm Off ............................................................................................................................................... 6-7
6.10 Set Nurse Call....................................................................................................................................... 6-7
6.11 Alarm Tests .......................................................................................................................................... 6-8
6.11.1 Battery in Use ................................................................................................................................ 6-9
6.11.2 Power Failure Alarm ..................................................................................................................... 6-9
6.11.3 Paw Too High ................................................................................................................................ 6-9
6.11.4 Paw Too Low ................................................................................................................................ 6-9
6.11.5 TVe Too Low .............................................................................................................................. 6-10
6.11.6 TVe Too High.............................................................................................................................. 6-10
6.11.7 MV Too Low ............................................................................................................................... 6-10
6.11.8 MV Too High .............................................................................................................................. 6-10
6.11.9 O2 Supply Failure ........................................................................................................................ 6-10
6.11.10 PEEP Too Low .......................................................................................................................... 6-10
6.11.11 Airway Obstructed..................................................................................................................... 6-11
6.11.12 Tube Disconnected .................................................................................................................... 6-11
6.11.13 Apnea Alarm ............................................................................................................................. 6-11
6.11.14 FiO2 Too High ........................................................................................................................... 6-12
6.11.15 FiO2 Too Low ............................................................................................................................ 6-12
6.11.16 EtCO2 Too High ........................................................................................................................ 6-12
6.11.17 EtCO2 Too Low ......................................................................................................................... 6-12
6.11.18 SpO2 Too high ........................................................................................................................... 6-12
6.11.19 SpO2 too low.............................................................................................................................. 6-13
6.11.20 PR Too High .............................................................................................................................. 6-13
6.11.21 PR Too Low .............................................................................................................................. 6-13
6.12 Alarm Handling Measures .................................................................................................................. 6-13

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 Operating Instructions for V3/V3A Ventilator

Chapter 7 Start Ventilation ............................................................................................................................... 7-1

7.1 Start System............................................................................................................................................ 7-1
7.2 System Check ......................................................................................................................................... 7-1
7.3 Select Patient .......................................................................................................................................... 7-2
7.4 Ventilation Type ..................................................................................................................................... 7-3
7.4.1 Invasive Ventilation......................................................................................................................... 7-3
7.4.2 Non-invasive Ventilation................................................................................................................. 7-3
7.4.3 Set Ventilation Type ........................................................................................................................ 7-4
7.5 Ventilation Mode .................................................................................................................................... 7-4
7.5.1 Ventilation Mode and Parameter Settings ....................................................................................... 7-5
7.5.2 Apnea Ventilation Mode ................................................................................................................. 7-5
7.5.3 Leak Compensation ......................................................................................................................... 7-6
7.5.4 V-A/C .............................................................................................................................................. 7-7
7.5.5 P-A/C ............................................................................................................................................... 7-8
7.5.6 V-SIMV ........................................................................................................................................... 7-9
7.5.7 P-SIMV ......................................................................................................................................... 7-11
7.5.8 CPAP/PSV..................................................................................................................................... 7-12
7.5.9 PRVC............................................................................................................................................. 7-14
7.5.10 PRVC-SIMV ............................................................................................................................... 7-15
7.5.11 DuoVent ...................................................................................................................................... 7-16
7.5.12 APRV .......................................................................................................................................... 7-17
7.5.13 VS ................................................................................................................................................ 7-17
7.5.14 PSV-S/T....................................................................................................................................... 7-19
7.6 Alarm Limit Settings ............................................................................................................................ 7-20
7.7 Start Ventilation ................................................................................................................................... 7-20
7.8 Ventilation Parameters ......................................................................................................................... 7-20
7.9 Enter Standby ....................................................................................................................................... 7-22
7.10 Shut Down .......................................................................................................................................... 7-22
Chapter 8 CO2 Monitoring ............................................................................................................................... 8-1
8.1 Overview ................................................................................................................................................ 8-1
8.1.1 CO2 derived functions ..................................................................................................................... 8-1
8.2 Safety Information .................................................................................................................................. 8-2
8.3 Adverse Effects on Performance ............................................................................................................ 8-3
8.4 CO2 Measure .......................................................................................................................................... 8-4
8.4.1 Preparations for Mainstream CO2 Sensor Connection .................................................................... 8-4
8.4.2 Preparations for Sidestream CO2 Sensor Connection ...................................................................... 8-5
8.4.2.1 Preparations for Respironics Sidestream CO2 Sensor ............................................................... 8-5
8.4.2.2 Preparations for Masimo Sidestream CO2 Sensor .................................................................... 8-6
8.4.2.2.1 Pre-use Checks .................................................................................................................. 8-7
8.4.2.3 Preparations for Comen Sidestream CO2 Sensor ...................................................................... 8-7
8.5 Zero CO2 Sensor ..................................................................................................................................... 8-8
8.5.1 Zero Mainstream CO2 Sensors ........................................................................................................ 8-8
8.5.2 Zero Respironics and Comen Sidestream CO2 Sensors................................................................... 8-8
8.5.3 Zero Masimo Sidestream CO2 Sensors............................................................................................ 8-9
8.6 CO2 Setting ............................................................................................................................................. 8-9
8.6.1 CO2 Monitoring Setting ................................................................................................................... 8-9
8.6.2 Set CO2 Alarm ................................................................................................................................. 8-9

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8.6.3 Set O2 Compensation ....................................................................................................................... 8-9

8.6.4 Set CO2 Unit .................................................................................................................................. 8-10
8.6.5 Set Altitude .................................................................................................................................... 8-10
8.6.6 Set Waveform ................................................................................................................................ 8-12
8.7 Information on MASIMO Module ....................................................................................................... 8-12
8.7.1 CO2 Module LED .......................................................................................................................... 8-12
8.7.2 Warning Information ..................................................................................................................... 8-13
8.7.2.1 ISA Sidestream Gas Analyzer Warning Information .............................................................. 8-13
8.7.2.2 IRMA Mainstream Gas Analyzer Warning Information ......................................................... 8-14
8.7.3 Airway Obstruction ....................................................................................................................... 8-15
8.7.4 Leakage Test.................................................................................................................................. 8-15
8.7.5 Safety Symbols .............................................................................................................................. 8-15
8.7.6 Patents and Trademarks ................................................................................................................. 8-16
8.7.7 Consumables.................................................................................................................................. 8-17
8.7.7.1 ISA Nomoline Family............................................................................................................. 8-17
8.7.7.2 IRMA Airway Adapter ........................................................................................................... 8-18
8.7.8 Maintenance .................................................................................................................................. 8-19
Chapter 9 SpO2 Monitoring (Available for V3 Only) ...................................................................................... 9-1
9.1 Overview ................................................................................................................................................ 9-1
9.1.1 Identification of SpO2 Sensor Type ................................................................................................. 9-1
9.2 Safety Instructions .................................................................................................................................. 9-2
9.3 SpO2 and PR Accuracy Test ................................................................................................................... 9-7
9.4 Measurement Restrictions ...................................................................................................................... 9-7
9.5 SpO2 Display .......................................................................................................................................... 9-7
9.6 Monitoring Steps .................................................................................................................................... 9-9
9.6.1 Comen SpO2 Measurement Steps .................................................................................................... 9-9
9.6.2 Masimo SpO2 &Nellcor SpO2 Measurement Steps ......................................................................... 9-9
9.7 Placement of SpO2 Sensor ...................................................................................................................... 9-9
9.7.1 Placement of Adult SpO2 Sensor ..................................................................................................... 9-9
9.7.2 Placement of Pediatric SpO2 Sensor.............................................................................................. 9-10
9.7.3 Placement of Disposable SpO2 Sensor .......................................................................................... 9-10
9.8 SpO2 Setup ........................................................................................................................................... 9-11
9.8.1 SpO2 Monitoring Setting ............................................................................................................... 9-11
9.8.2 Open SpO2and PR Alarm .............................................................................................................. 9-11
9.8.3 Set SpO2 Alarm Level ................................................................................................................... 9-11
9.8.4 Set PR Alarm Level ....................................................................................................................... 9-11
9.8.5 Set SpO2 Alarm ............................................................................................................................. 9-11
9.8.6 Set PR Alarm ................................................................................................................................. 9-12
9.8.7 Set Waveform Speed ..................................................................................................................... 9-12
9.8.8 Set Pulse Volume .......................................................................................................................... 9-12
9.8.9 Set Sensitivity (Available for Masimo SpO2 Only) ....................................................................... 9-12
9.8.10 Set Smart Pulse Sound (Available for Masimo SpO2 Only) ....................................................... 9-12
9.8.11 Set SatSeconds(Available for Nellcor SpO2 Only)...................................................................... 9-12
9.8.12 Set Average Time ........................................................................................................................ 9-13
9.8.12.1 Set Masimo SpO2 Average Time .......................................................................................... 9-13
9.8.12.2 Set Comen SpO2 Average Time ............................................................................................ 9-14
9.8.13 Set Nellcor SpO2 Average Time .................................................................................................. 9-14

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 Operating Instructions for V3/V3A Ventilator

9.8.14 Set Signal Indication(Unavailable for Nellcor SpO2 Only) ......................................................... 9-14
9.8.15 Fast Sat ........................................................................................................................................ 9-14
9.9 Masimo Information ............................................................................................................................. 9-14
Chapter 10 Other functions ............................................................................................................................ 10-1
10.1 Manual Breath .................................................................................................................................... 10-1
10.2 Expiratory Hold .................................................................................................................................. 10-1
10.3 Inspiratory Hold ................................................................................................................................. 10-2
10.4 O2↑ (O2 Enrichment) ....................................................................................................................... 10-2
10.5 Suction ................................................................................................................................................ 10-3
10.6 Nebulizer ............................................................................................................................................ 10-3
10.7 P0.1 ..................................................................................................................................................... 10-4
10.8 PEEPi ................................................................................................................................................. 10-5
10.9 NIF ..................................................................................................................................................... 10-5
10.10 P-V Tools ......................................................................................................................................... 10-6
10.11 Recruitment Tool (SI)....................................................................................................................... 10-7
10.12 O2 Therapy ....................................................................................................................................... 10-7
10.12.1 Enter Oxygen Therapy Interface ............................................................................................... 10-8
10.12.2 Oxygen Therapy Timer/Timing................................................................................................. 10-8
10.12.3 Turn Off Oxygen Therapy ......................................................................................................... 10-9
10.13 Tube Resistance Compensation (TRC) ............................................................................................ 10-9
10.14 IntelliSyn Smart Sync Technology ................................................................................................. 10-10
10.15 Network settings ............................................................................................................................. 10-10
Chapter 11 Battery.......................................................................................................................................... 11-1
11.1 Overview ............................................................................................................................................ 11-1
11.2 Optimize and Check Battery Performance ......................................................................................... 11-2
11.2.1 Optimize Battery Performance .................................................................................................... 11-2
11.2.2 Check Battery Performance ......................................................................................................... 11-2
11.3 Store the Battery ................................................................................................................................. 11-3
11.4 Battery Recycling ............................................................................................................................... 11-3
Chapter 12 Cleaning, Disinfection and Sterilization ...................................................................................... 12-1
12.1 Overview ............................................................................................................................................ 12-1
12.2 Cleaning, Disinfection and Sterilization Methods .............................................................................. 12-3
12.2.1 Cleaning, Disinfection and Sterilization of Main Unit and Patient’s Circuit .............................. 12-3
12.2.2 Cleaning and Disinfection of Physiological Module Accessories ............................................... 12-6
12.3 Disassemble the Ventilator’s Cleanable and Disinfectable Parts ....................................................... 12-8
12.3.1 Expiratory Valve Component and Diaphragm ............................................................................ 12-8
12.3.2 Inspiratory Valve Component and Diaphragm ............................................................................ 12-9
12.3.2.1 Inspiratory Valve Component ............................................................................................... 12-9
12.3.2.2 Inspiratory safety valve diaphragm .................................................................................... 12-10
12.3.3 High-efficiency Particulate Air (HEPA) and Dust Mesh .......................................................... 12-11
12.3.4 Fan dust Mesh............................................................................................................................ 12-12
12.3.5 Breathing tube ........................................................................................................................... 12-12
12.3.6 Nebulizer ................................................................................................................................... 12-14
12.3.7 Humidifier ................................................................................................................................. 12-15
12.3.7.1 Removal of Humidifier on the Ventilator ........................................................................... 12-15
12.3.7.2 Removal of Humidifier on the Tower ................................................................................. 12-16

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12.3.8 Mainstream CO2 Sensor ............................................................................................................ 12-17

Chapter 13 Maintenance ................................................................................................................................. 13-1
13.1 Service Principles ............................................................................................................................... 13-1
13.2 Maintenance Schedule ........................................................................................................................ 13-1
13.3 Zero Calibration of Pressure and Flow ............................................................................................... 13-4
13.4 Flow Calibration ................................................................................................................................. 13-4
13.5 O2 concentration calibration ............................................................................................................... 13-5
13.6 Handle Water Accumulation Problem in Flow Sensor....................................................................... 13-6
13.6.1 Prevent Water Accumulation....................................................................................................... 13-6
13.6.2 Clear Accumulated Water ........................................................................................................... 13-6
13.7 Electrical Safety Test.......................................................................................................................... 13-6
Appendix I Operating Principle........................................................................................................................ I-1
Appendix II Accessories .................................................................................................................................. II-1
Appendix III Product Specifications .............................................................................................................. III-1
Appendix IV Default Settings ........................................................................................................................ IV-1
Appendix V Alarm Messages .......................................................................................................................... V-1
Appendix VI EMC .........................................................................................................................................VI-1
Appendix VII Abbreviations ........................................................................................................................ VII-1
Appendix VIII The accuracy of SpO2 ......................................................................................................... VIII-1

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XII
 Chapter 1 Safety

This product does not involve any information about danger levels.

1.1 Safety Information

DANGER
 Indicates an imminently hazardous situation, which, if not avoided, could result in death,
serious injury or property damage.

WARNING
 Alerts you to situations that may result in serious consequences or adverse events or endanger
personal safety. Failure to observe the warning information may cause severe injury or even
death of user or patient.

CAUTION
 Alerts you to potential dangers or unsafe operations, which, if not avoided, may result in minor
injury, product failure or damage, or property damage, or cause more serious injury in the
future.

Note
 Emphasizes important precautions and provides instructions or explanations for better use of
the product.

WARNING
 This product can be used only by trained, qualified medical staff. Any unauthorized personnel
or personnel without training shall not perform any operations. The equipment must be
operated strictly in accordance with this manual.

 Prior to use, user must check the device and its accessories to ensure their normal and safe
operation.

 The equipment cannot be used with inflammable anesthetic gas mixed with air, oxygen or
nitrous oxide

1-1
 Safety

 To prevent damage to the ventilator, the ventilator is only connected to clean and dry medical
oxygen (≥99.5%).

 The ventilator can not be connected to oxygen 93, the accuracy of the O2 monitoring is not
maintained when used with Oxygen 93, it shall not be used with gas supplied from oxygen
concentrators.

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

 Do not place the ventilator near a barrier that will block cold air flow; otherwise the equipment
will be overheated

 Do not cover the ventilator or place in a position that affects proper operation, not block the
gas intake port or emergency intake port, thereby interfering with patient ventilation..

 Do not open the housing of the device to avoid the potential risk of electric shock. The
ventilator must be maintained and upgraded by service personnel having been trained and
authorized by Comen.

 Alarm volume and upper and lower alarm limits should be set depending on the patient. Do
not monitor the patient relying on the sound alarm system. If the alarm volume is set too low, it
may further endanger the patient. The most reliable monitoring method is to pay close
attention to the patient’s actual clinical condition.

 The physiological waveforms, parameters, alarms and other information displayed on the
screen of the equipment are only for reference by doctors, which shall not be used as a basis for
clinical treatment.

 All personnel shall be aware that the risk of infection exists on some parts of the ventilator
after using.

 The settings under maintenance menu can be modified only after disconnecting the patient
from the equipment.

 Positive pressure breathing may be accompanied by the following side effects: barotrauma,
hypoventilation, hyperventilation and other hazards.

 To avoid the risk of electric shock, this equipment must only be connected to a supply main
with protective earth. If the power socket is not connected to an earth conductor or there is any
doubt about the completeness of wiring, please use the rechargeable battery to supply voltage
to the device instead of using this socket

 Please use external power supply (AC/DC power supply) in time before the battery runs out.

 Please observe the local regulations or the hospital’s waste disposal policy when disposing of
packaging materials. Keep the packaging materials out of the reach of pediatric.

 Use of the ventilator near a high-frequency electrosurgical unit, defibrillator or short wave

1-2
 Safety

therapeutic apparatus will affect normal working of the ventilator and cause hazards to the
patient.

 To prevent electromagnetic interference from interrupting the operation of the ventilator, do

not use other devices near or together with the ventilator. If it is necessary to use other devices
near or together with the ventilator, please verify that the ventilator can work normally in the
setting state when other devices are used.

 Use of an anti-static or conductive mask or breathing tube when a high-frequency surgical

instrument is used could result in burn. Therefore, please do not use any anti-static or
conductive mask or breathing tube.

 Please carefully place the power cord and the cables of various accessories to prevent the
patient from getting wound or suffocated, entanglement of the cables, or electrical interference.

 If the monitoring system inside the equipment malfunctions, there must be an alternative
scheme to ensure monitoring of sufficient level. Under all circumstances, the ventilator
operator must be responsible for proper ventilation and safety of the patient.

 An alternative means of ventilation shall be available whenever the ventilator is in use. If a

fault is detected in the ventilator, disconnect the patient from it and immediately start
ventilation with such a device. For example, using a manual respirator.

 According to regulatory requirements, oxygen concentration monitoring is required when the

equipment is applied to the patient. If the equipment you are using is not provided with this
function or the function is disabled, please use a monitor compliant with ISO 80601-2-55) to
monitor oxygen concentration.

 The ventilator shall not be used in a hyperbaric chamber. Such use might cause the ventilator
to not function correctly, causing patient death or serious deterioration of health.

 When oxygen is used, the ventilator should be kept away from sources of ignition.

 The ventilator shall not be used with nitric oxide. Such use might cause the ventilator to not
function correctly, causing patient death or serious deterioration of health.

 When using nebulization or humidification, breathing system filters and heat and moisture
exchangers can require more frequent replacement to prevent increased resistance and
blockage.

 The ventilator accuracy can be affected by the gas added to the ventilator breathing system by
use of a pneumatic nebulizer.

 For non-invasive ventilation, the tidal volume actually exhaled by the patient will be different
from the monitored value from the ventilator due to the leakage around the mask.

 The ventilator cannot be used in poisonous or contaminated environment, which is to avoid

hazardous substances entering the patient circuit.

 All the analogy and digital equipment connected with this device must be the products in

1-3
 Safety

compliance with their IEC standards (e.g. IEC 60950-1 information technology
equipment-safety and IEC 60601-1 medical electrical equipment –safety). Anyone connecting
additional equipment to the signal input port or the signal output port configures a medical
system, and, therefore, is responsible that the system complies with the requirements of the ME
system according to IEC 60601-1. If in doubt, please contact our company.

 When the port is connected with patient or when replacing the O2 sensor, do not touch the
signal I/O port, otherwise the patient may get injured.

 Do not throw the O2 sensor into fire to prevent explosions.

 When the patient cable port, network port and other signal ports connected to multiple
equipment, the total leak current caused shall conform to IEC60601-1.

 This equipment cannot be used in a MRI environment.

 When the gas input system of the ventilator malfunctions or becomes abnormal, please contact
the manufacturer to repair the system by designated personnel.

 When passing the ventilator through an obstacle (e.g., threshold), please carefully move the
ventilator to avoid damage caused by toppling over.

 Before moving the ventilator, please remove the supporting arm to prevent the ventilator from
toppling over.

 When stop moving the ventilator, please press down the brake pedal to avoid damage caused
by accidental movement of the ventilator.

 To avoid personal injury or equipment damage, please ensure that the ventilator has been
secured to a trolley or placed on a safe and steady platform.

 To prevent the patient from the harm caused by equipment, when the [Technical Error **] or
[Device Failure **] alarm is triggered, please remove the equipment immediately, record the
failure code and contact our After-sales Service Department.

 To avoid malfunction of the ventilator, do not splash or spatter any liquid onto the ventilator.

 The blower fan will cause the gas being heated. Please ensure the pipe length from humidifier
to the Y-pipe greater than 1.2 m, so as to reduce the gas temperature in pipe and prevent the
patient from being injured.

 When the buzzer alarms, please stop using the ventilator immediately and contact our
After-sales Service Department.

 Do not modify this equipment without authorization of the manufacturer.

 Equipment and accessories s cannot be stored and used in extreme environments.

 Defibrillation energy has no effect on the applied parts of the ventilator.
 Always have immediate access to an alternative means of ventilation, which is ready for use, in
order to reduce the possibility of patient death or serious deterioration of health.

1-4
 Safety

 The ventilator shall not be used with inlet gases, which are not specified for use (e.g. helium or
mixtures with helium). Such use might cause the ventilator to not function correctly, causing
patient death or serious deterioration of health.
 It is the responsibility of the responsible organization to ensure that the oxygen source is
compatible with the rated range of pressure, flow rate and oxygen concentration as marked on
the ventilator and indicated in the instructions for use as this can affect the performance of the
ventilator that can consequently result in patient death or serious deterioration of health.
 To avoid contaminating or infecting personnel, the environment, or other equipment, make
sure you disinfect and decontaminate the device and any appropriate accessories prior to
disposal.

CAUTION
 The ventilator is suitable for use in patient environments.

 The ventilator must be maintained and checked regularly by specially trained personnel.

 To ensure safety, an artificial respirator must be always kept ready.

 When a mask is used for ventilation, avoid high airway pressure because this may cause
gastrectasia.

 When Ppeak is greater than 33cmH2O, the risk of gaseous distention can be increased. At the
moment, invasive ventilation shall be considered to use.

 Once the ventilator is connected to the patient, there should always be a appointed one to watch
and monitor the operation status of the equipment.

 During the ventilator running, do not dismantle the inspiratory valve component and the
expiratory valve component unless the ventilator is in standby.

 Electromagnetic field may affect the performance of the equipment. Therefore, other devices
used near the equipment shall conform to the applicable EMC requirements. Mobile phones or
X-ray are all potential sources of interference since they all transmit high-intensity
electromagnetic radiation.

 This system can work normally under the anti-interference level identified in this User Manual.
If the interference level is higher than this level, an alarm could be triggered, and mechanical
ventilation may stop. Take care to avoid false alarms of the system caused by high-intensity
electric field.

 To reduce the risk of fire, do not use any gas hose component that is worn or contaminated by
combustible material (e.g., oil, grease).

 To reduce the risk of fire, only use hoses that are approved for medical purposes for connecting
the oxygen source to the ventilator.

1-5
 Safety

 To reduce the risk of fire, please cut off the oxygen source when the ventilator is not in
ventilation state.

 To reduce the risk of fire, please ensure good ventilation at the back of the ventilator.

 To avoid equipment damage and ensure patient safety, please use accessories specified in this
User Manual.

 Clinicians are responsible for correct setting of the ventilator.

 Before using the ventilator or when deviation exists in the measured value, please calibrate the
flow sensor.

 A fan failure may cause an increase in the oxygen concentration inside the device, which may
cause in a fire or explosive hazard.

 To reduce the risk of explosion, do not forcibly open the oxygen sensor or throw it into fire.

 To avoid the risk of fire, only use the specified fuses or fuses having the same type, rated
voltage and rated current as the existing fuses. To replace fuses, please contact our After-Sales
Service Department.

 To avoid patient injury, please select the correct patient type, set the ventilation parameters
correctly and connect the proper breathing tube. Before the ventilator is applied to each
patient, please ensure that the system check result is OK.

 To ensure the accuracy of oxygen concentration monitoring, please replace the damaged
oxygen sensor in time, or use an external monitor conforming to the requirements of ISO
80601-2-55.

 Please properly install or relocate the equipment to avoid damage due to drop, collision, strong
oscillation or other external mechanical forces.

 Before moving the ventilator, please ensure that the casters and brake pedals work normally
and that the main unit of ventilator has been locked onto the trolley.

 Before powering on the device, please confirm that the supply voltage and frequency conform
to the requirements specified on the device nameplate or in this manual.

 To achieve electrical isolation between the ventilator and input power, please disconnect the
power plug of the ventilator.

 Avoid long-term storage of the ventilator in an environment over 50℃. Such environment could
damage the internal battery and oxygen sensor or reduce the battery life.

 When the useful life of the equipment or its accessories or medical waste is in expiry, please
dispose of in accordance with the local regulations or the hospital’s rules.

 Additional power strip and extension cord should not be connected to this Ventilator.

1-6
 Safety

 Use the original package to transport the ventilator.

Note
 Please put the device in a place where observation, operation and maintenance are convenient.

 This manual introduces the product of the most complete configurations. Some configurations
or functions may not be available on the product you have purchased.

 Please keep this manual near the device for easy and prompt access when needed.

 The device can be used for only one patient at a time.

 The software contained in this equipment has been developed in accordance with the
requirements of IEC62034 to minimize the probability of risks caused by program error.

 Service life (25℃±5℃): 10 years (may shorten due to extreme environmental condition).

1.2 Contraindications

This product has no absolute contraindications. For some special diseases, however, necessary measures
should be taken to proceed mechanical ventilation of the ventilator or a special ventilation mode should be
used; otherwise the patient could be adversely affected.

1.3 Equipment Symbols

 Device Symbols
Environment-friendly use
Caution period of electronic
information products
Defibrillation-proof Type CF Defibrillation-proof Type BF
applied part applied part
AC/DC power Battery

Power switch Alarm audio paused

Lock Unlock

Equipotentiality Fuse

High-pressure oxygen supply Low-pressure oxygen supply

connector connector

1-7
 Safety

Direct current input port Ventilator gas outlet

Nebulizer connector Oxygen sensor connector

Inspiratory connector Expiratory connector

WARNING:Gas Intake.DO WARNING:Gas Intake - DO

NOT OBSTRUCT! NOT OBSTRUCT!
Degree of protection provided
Serial number IP21
by enclosure

Date of manufacture Manufacturer

Follow Instruction For Use Nurse call connector

VGA connector Network connector

Separate collection of WEEE USB connector

Equipment weight Safe working load

This way up Stacking layer limit

Fragile, handle with care Keep dry

Temperature limit Atmospheric pressure limit

European community
Humidity limit
representative
Complies with medical device DO NOT USE IF PACKAGE
directive 93/42/EEC IS DAMAGED

Adult（Male） Pediatric（Male）

Adult（Female） Pediatric（Female）

Invasive ventilation Non-invasive ventilation

Alarm setup Setup

Tools key Freeze key

History Inspiratory trigger

1-8
 Safety

O2↑key Screenshot

Alarm off Nebulizer

Recent alarm Standby key

Open state Off state

O2 Sensor installation
Clear alarm
instruction

High Efficiency Particle Air

/ /
(HEPA) installation instruction

1-9
 Chapter 2 Product Overview

2.1 Product Composition

The product consists of a main unit (including pneumatic circuit, electronic system, mechanical structure,
display, CO2 module and SpO2 module), trolley, support arm and accessories.

2.2 Intended Use

The product is intended for use in the ICU or internal transfer within the professional healthcare facilities. It
provides assisted ventilation and respiratory support, SpO2 and CO2 monitoring for adult, pediatric and infant
(＞3kg).

2.3 Product Appearance

2.3.1 Overall Appearance

(13)
(1)
(2)
(3)
(12) (4)
(11) (5)

(10)
(9)
(8)
(6)

(7)

(1) Leak test plug

2-1
 Product Overview

For system check or flow calibration.

(2) Main unit
(3) Expiratory filter
To prevent bacteria in the patient circuit from getting into the ventilator's internal airway.
(4) Inspiratory filter
To prevent bacteria in the patient circuit from getting into the ventilator's internal airway.
(5) Inspiratory tube
(6) Spare cylinder fixing buckle
(7) Casters and brake pedal
The ventilator has four casters. Each of them has a brake pedal.
(8) Inspiratory water trap
Collects condensed water in the inspiratory tube.
(9) Expiratory water trap
Collects condensed water in the Expiratory tube.
(10) Expiratory tube
(11) Test lung
(12) Nebulizer connector
To connect the nebulizer.
(13) Support Arm
Supports and hangs the patient tubing.

2-2
 Product Overview

2.3.2 Main Unit Appearance

2.3.2.1 Front View

(1)

(2)

(3)
(4)
(5)
(6)
(7)

(8)
(10)
(9)
The control equipment consists of several operating elements. Main operating elements are:
(1) Alarm indicator light
When an alarm is generated, the alarm indicator lights will indicate different levels of alarm in different
colors and blinking frequencies.
(2) Screen (Touch screen)
Software interfaces of ventilator system are displayed on the screen. Settings can be selected and
changed by touching.
(3) Control knob
Menu items can be selected or settings can be confirmed by pressing the main control knob. Menu items
can be scrolled or settings can be changed by rotating it clockwise or counterclockwise.
(4) Alarm audio paused button
When this button is pressed, the system will enter the alarm audio paused state for 120 sec, and the alarm
sound currently produced can be turned off. When 120 sec countdown is ended, the system will cancel
the current alarm audio paused state and restore the sound alarm. When a new alarm is generated during
the alarm audio paused state, the system will not restore the sound alarm. In alarm audio paused state,
click the button again, the system will cancel the current alarm audio paused state.
(5) External power indicator light
 Lit: the ventilator is connected to external power supply (AC/DC).
 Not lit: the ventilator is not connected to external power supply (AC/DC).

2-3
 Product Overview

(6) Battery indicator light

 Lit: battery is full. The ventilator is connected to external power supply (AC/DC), or the ventilator
isn’t connected to external power supply (AC/DC) and it is battery-powered.
 Flash: the battery is charging.
 Not lit: battery is not installed or battery is faulty, or the ventilator isn’t connected to external power
supply (AC/DC) when it power off.
(7) Power switch (with indicator light)
Press the button to turn on/off the system. The button light constant on when the system is turned on,
goes off when the system is turned off.
(8) Inspiratory connector
connected to inspiratory tube
(9) Nebulizer connector
(10) Expiratory connector
connected to expiratory tube

2.3.2.2 Left View

(1)

(2)
(3)

(4)

(1) SpO2 cable connector

(2) Masimo sidestream CO2 outlet
(3) CO2 cable connector (sampling line connector for Masimo sidestream CO2)
(4) Ventilator gas outlet

2-4
 Product Overview

2.3.2.3 Right View

(1)

(2)

(1) Leak test plug

(2) O2 sensor compartment

2.3.2.4 Rear View

(9)
(1)
(8) (2)

(7)

(6) (3)

(4)
(5)

(1) USB connector

Export configuration information and historical data (such as patient data, alarm log); Transmit
configuration information with a ventilator of the same model via the USB flash drive; Connect
Electronic Nebulizer.

2-5
 Product Overview

(2) VGA connector

Connect an external display which can display pictures the same as those on the ventilator display.
Connect an external display (supporting display with resolution of 1280*800 )
(3) Inlet of High-pressure O2 supply
(4) Inlet of Low-pressure O2 supply
(5) DC power connector
(6) AC appliance inlet
(7) Potential equalization conductor
when used other equipment with ventilator together, equipotential ends of other equipment and ventilator
shall be connected by cables, to eliminate earth potential difference among different equipment and keep
safe.
(8) Nurse call connector
When connected with calling system of hospital, if an alarm is triggered, nurse call message will be
prompted.
(9) Network connector
used for network communication.

2.3.2.5 Bottom View

(1) (1)

(1) Battery compartment

2-6
 Chapter 3 Installation & Connection

WARNING

 When accessories or other components are added on the respiratory system of ventilator,
expiratory/inspiratory resistance of the system might be increased.

 Use of an anti-static or conductive mask or breathing tube could result in burn. Therefore, do
not use any anti-static or conductive mask or breathing tube.

 Each time a pipe, humidifier, breathing filter or other accessory or component is replaced,
system check must be performed again.

 Components not specified in ventilator accessories shall not be installed in ventilator.

3.1 Unpacking and Checking

Carefully take the ventilator and its accessories out of the packing box; properly keep the packaging materials
for use in future transportation or storage. Check the accessories according to the Packing List. Check to see if
there is any mechanical damage. In case of any problem, contact our Sales Department or agency
immediately.

WARNING
 If you find any damage, contact the related hospital staff or After-sales Service Department of
Comen company.

3.2 Environmental Requirements

Operating environment of this equipment must meet the environmental specifications in this manual. If the
ambient temperature is beyond prescribed range, the accuracy of the device may be affected, and damage to
components and circuits may be caused.
The equipment should be used in an environment that can reasonably avoid vibration, dust, corrosive or
explosive gases, extreme temperature and humidity, etc.
Please ensure that the device is free from condensation during operation. When the device is moved from one
room to another, condensation may be formed. This is because the device is exposed to damp air and different
temperatures. In order to avoid unnecessary troubles, use the device when it is dry if it is subjected to
condensation.

3-1
 Installation & Connection

Note

 Condensation is formed when a gas or liquid touches a cold surface. For example, water
vapor changes to water and water changes to ice when touching a cold surface. The lower
the temperature is, the faster the condensation will be.

3.3 Install the Main Unit

(1)

(2)
(3)

(4)

(1). Main unit (2). Positioning post (3). Trolley unlock button (4). Trolley

Align the main unit at two positioning posts on the trolley and place it on the trolley.
If the main unit need to be removed from the trolley, press the trolley unlock button at first, then lift the main
unit with both hands.

3.4 Connect to the Power Supply

3.4.1 Connect to AC Power Supply

As illustrated in following figure, plug the power cord into the power socket.

3-2
 Installation & Connection

(3)
(1)

(2)

(1). Power cord bail latch (2). AC power cord (3). AC power socket

3.4.2 Connect to DC Power Supply

(1)
(2)
(3)

(1). DC-IN port (2). Unlocking device (3). DC power cord

Align the red anchor point on the DC power cord at the red anchor point on the DC power connector, then
plug the DC power cord into the DC power connector. You will hear a “snap” when it is installed in place.
When disconnecting the DC power supply, just pull the unlocking device axially, then the bail latch is
unlocked, and remove the plug from the socket.

3-3
 Installation & Connection

3.5 Connect to the Gas Supply

WARNING

 Check the O2 source port carefully to ensure there are no leaks. Too much leakage will lead to
an oxygen concentration increase near the device, so there will be a potentially hazardous
oxygen-enriched environment.

 Place the O2 source hose carefully, to avoid exposing it to the environment where it may get cut,
heated or damaged.

 To reduce the risk of fire, transport the Low-pressure O2 with a flow no larger than 15 l/min.

CAUTION
 When Low-pressure O2 is used, oxygen concentration setting of the ventilator is invalid. To
prevent patient injury, ensure an abundant O2 supply before using Low-pressure O2.

 Before starting the ventilation, ensure the O2 source is properly set. Set the Gas supply type
based on the actual situation. Refer to “Section 5.10 Set O2 Supply Type” for setting method.

 To prevent patient injury, ensure the emergency O2 source (e.g. oxygen cylinder) is available
when a failure happens in Low-pressure O2 supply.

 Low-pressure O2 hose should conform to the requirements of ISO 5359.

(1)
(2) (3)
(4)
(1). High-pressure O2 port (2). High-pressure O2 hose and connector

(3). Low-pressure O2 port (4). Low-pressure O2 hose and connector

3-4
 Installation & Connection

This ventilator provides two types of gas supply connection: High-pressure O2 supply connector and
Low-pressure O2 supply connector.
When the ventilator is connected to High-pressure O2, nominal gas supply pressure is 280~600 kPa. When
Gas Supply Pressure is less than 280 kPa, the ventilator performance will be affected, even the ventilation will
be stopped. When Gas Supply Pressure is 600~1000 kPa, the ventilator performance will be affected, but no
any harm will be caused due to high-pressure gas. Connecting steps of High-pressure O2 are as follows:
1) Before connecting the Gas Supply pipe, check whether the seal ring at the joints are in good condition. If
the seal ring is damaged, the pipe cannot be used. Replacing the seal ring is a must to avoid leakage.
2) Align the joint and insert it into the High-pressure O2 connector on the back of the ventilator.
3) Ensure a correct connection between Gas Supply hose and port, manually screw the hose nut tightly.
When the ventilator is connected to Low-pressure O2, the flow rate of which shall not exceed 15 l/min. To
reduce fire risks, do not use a Low-pressure O2 which output at a flow rate exceeding 15 l/min. Connecting
steps of Low-pressure O2 are: align the Low-pressure O2 hose and insert it into the Low-pressure O2 supply
connector. You will hear a “snap” when Gas Supply hose is installed in place. Before removing it, press the
metal clip on the Low pressure-O2 supply connector, and pull the Gas Supply hose out.

3.6 Install the Support Arm

WARNING

 Before moving the ventilator, remove the supporting arm to prevent the ventilator from
toppling over.

 Check whether the handle of supporting arm is tightly and safely connected as required to
prevent the patient from accidental injury.

Note
 The maximum bearing capacity of the supporting arm does not exceed 0.8 kg.

 The supporting arm can be installed on the rail on the left or right side of the ventilator.

3-5
 Installation & Connection

(2) (1)
(1) (3)

(4)

(2)

(5)
(6)

(1). Supporting rod (2). Locking handle (3). Locking handle of pipe hook

(4). Pipe hook (5) Fixing block (6). Fixing block knob

1) Tighten the locking handle on the supporting arm.

2) Insert the supporting arm into the mounting hole on the fixing block.
3) Loosen the fixing block knob, and place the fixing block on the rail on the side of the ventilator.
4) Tighten the fixing block knob.
5) Adjust the supporting arm.
If you need to adjust bending angle of supporting arm upward or downward, hold the supporting rod at
the back-end of locking handle with one hand, while holding the supporting rod at the front-end of
locking handle with the other hand at the same time, move it upward or downward to the required
position.
6) Install the pipe hook on the supporting arm, screw up the locking handle of pipe hook.
7) Put the breathing tube on the pipe hook.

3-6
 Installation & Connection

3.7 Install the Patient Tubing

WARNING

 To minimize the risk of bacterial contamination or physical damage, carefully remove and
install the bacterial filter.

 To prevent patient or ventilator contamination, a bacterial filter should always be used between
the ventilator and the patient inspiratory limb.

CAUTION
 Use of the expiratory filter may result in dramatic increase of expiratory impedance. Excessive
expiratory impedance may endanger ventilation and increase the patient's work of breathing
and intrinsic PEEP.

 The breathing tube should conform to the requirements of ISO 5367.

 The bacterial filter should conform to the requirements of ISO 23328-1 and ISO 23328-2.

 A heat and moisture exchanger (HME) should conform to the requirements of ISO9360-1 and
ISO9360-2.

3-7
 Installation & Connection

(3)
(4)
(5)

(2)
(1)

(1) Inspiratory water trap (2) Expiratory water trap (3) Pipe hook
(4) Inspiratory filter (5) Expiratory filter
1) Install the filters at the inspiratory and expiratory ports, respectively.
2) Connect the inspiratory filter to the water collection cup via the tube, and connect the other end of the
tube to the Y-pipe.
3) Connect the expiratory filter to the water collection cup via the tube, and connect the other end of the
tube to the Y-pipe.
4) Connect the patient end of Y-pipe to the patient.
5) Lastly, put the breathing tube on the pipe hook of the supporting arm.

3.8 Install the Humidifier

WARNING

 To avoid patient injury and equipment damage, don't turn on the humidifier until the
ventilator is calibrated and ventilated.

 To avoid patient injury and equipment damage, ensure that the humidifier is set to a proper
temperature and humidity. Always use the humidifier within its rating and intended operation
condition, otherwise it may reduce the performance of humidifier, which may lead to injury to
patients, especially for invasive ventilation mode. For example, the elevated temperature of gas

3-8
 Installation & Connection

intake can cause the humidifier to reduce humidity output below the limited allowed by ISO
80601-2-74.

 To prevent possible patient injury or equipment damage, do not start the humidifier between
the beginning and stabilization of the airflow. Start heating without airflow, or keeping it
started for a longer period of time, may cause heat to build up, and hot air to be delivered to
the patient. The breath tubing may melt in this case. Do turn off the humidifier before stop
ventilation.

CAUTION
 The humidifier should conform to the requirements of ISO 80601-2-74. The humidifier
components and installation steps described in this section are for reference only.

3.8.1 Install the Humidifier to the Ventilator

(3) (4)

(2)
(1) (5)
(6)

(1).Screw (2).Humidifier (3).The humidifier outlet

(4).The humidifier inlet (5).Retaining bracket of humidifier holder (6). Humidifier pulley

3-9
 Installation & Connection

1) Align the humidifier pulley at the retaining bracket of humidifier holder, and slide in.
2) Tighten the screws.
3) Install the filters at the inspiratory and expiratory ports, respectively.
4) Connect the inspiratory filter to the humidifier inlet via the tube.
5) Connect the humidifier outlet to the water trap via the tube, and connect the water trap to the Y-pipe via
the tube.
6) Connect the expiratory filter to the water trap via the tube, and connect the water trap to the Y-pipe via
the tube.
7) Put the breathing tube on the pipe hook of the supporting arm.

3.8.2 Install the Humidifier to the Ceiling Pendant

(1)
(2)
(3)
(4)
(7)
(5)
(6)
(1) Humidifier (2) Fixing block knob (3) Fixing block
(4) Humidifier pulley (5) Retaining bracket of humidifier holder (6) Screw

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(7) Flat-tube beam

1) Loosen the fixing block knob and place the fixing block on the flat-tube beam of the Ceiling Pendant.
2) Tighten the fixing block knob.
3) Align the humidifier pulley at the humidifier holder, and slide in.
4) Tighten the screw.
5) Install the patient tubing. See step 3 and step 7 in 3.8.1 for specific connecting method.

WARNING

 When installing humidifier, ensure the humidifier port is lower than respiratory port of
ventilator and patient.

3.9 Install the Nebulizer

CAUTION
 To prevent blockage of the expiratory valve caused by nebulization, only use drugs medically
approved for nebulization, and regularly check, clean or replace the expiratory valve
diaphragm.

 During nebulization, do not use the expiratory filter or the heat and moisture exchanger (HME)
in the breathing tube of the patient. Nebulization will cause filter blockage at the expiratory
side, greatly increase the air resistance and impede ventilation.

 Please connect the Nebulizer in the inspiratory limb. Connection of the Nebulizer between the
patient connection port and the tracheal tube will increase the dead space volume.

Note
 Please install a Nebulizer conforming to the specification requirements. The Nebulizer
components and installation steps described in this section are for reference only. For
installation and use of the Nebulizer, refer to the operating instructions supplied with the
Nebulizer.

 The USB interface of the equipment supports the connection of USB electronic Nebulizer. For
installation and use of the Nebulizer, refer to the operating instructions supplied with the
Nebulizer.

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3.9.1 Install Pneumatic Nebulizer

(3)
(1)

(2)

(1) Nebulizer connector (2) Nebulizer tube (3) Nebulizer

1) Install one end of the Nebulizer tube to the Nebulizer connector, and the other end to the Nebulizer.
2) Install the Nebulizer on the inspiratory limb of the breathing tube via the tube.

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3.9.2 Install Electronic Nebulizer

(1) (3)
(2)

(1) Nebulizer (2) USB controller (3) Nebulizer connector

1) Insert the USB connector of USB controller into the USB port back the ventilator.
2) Connect the nebulizer with the patient tube. Refer to the nebulizer accompanying operator’s manual for
the details.

WARNING

 Always maintain the nebulizer in a vertical orientation while in the patient circuit. This
orientation helps prevent patient secretions and condensate from contaminating the aerosol
generator of the nebulizer and ensures proper nebulization.

 Refer to the nebulizer accompanying operator’s manual to install and use the nebulizer.

3.10 Install the Oxygen Sensor

CAUTION
 To reduce the risk of explosion, do not burn or forcibly open the oxygen sensor.

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 Installation & Connection

(1)

(2)

(4) (3)

(1) Oxygen sensor connection cable (2) Oxygen sensor cover

(3) Retaining bracket (4) Oxygen sensor
1) Tighten the oxygen sensor clockwise;
2) Connect the oxygen sensor connection cable;
3) Push the oxygen sensor and its retaining bracket into the ventilator;
4) Fasten the oxygen sensor cover.

3.11 Install the Gas Cylinder

CAUTION
 Please ensure that the gas cylinder is equipped with a reducing valve.

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 Installation & Connection

(1)

(2)

(3)

(1) Gas cylinder (2) Cylinder fixing buckle (3) Chassis of the trolley
1) Put the gas cylinder in the chassis of the trolley.
2) Use the cylinder fixing buckle to fix the gas cylinder.

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 Chapter 4 Interfaces

4.1 Main interface

The ventilator display shows ventilation parameters, pressure/flow/volume waveforms and spirometry loops,
etc.
The figure below is a waveform interface in certain configuration. The interfaces displaying varies with
different configuration.

(1) (2) (3) (4) (5) (6) (7) (9) (10)

(8)

(11)

(15)

(12)

(14)

(13)

(1) Ventilation mode area

Displays Standby or active ventilation mode and ventilation assist indication.
(2) Ventilation type prompt area
Invasive or non-invasive ventilation type is displayed:
 When performing non-invasive ventilation, the non-invasive mask icon and NIV are
displayed;
 When performing invasive ventilation with TRC function being disabled, the intubation icon is
displayed; When performing invasive ventilation with TRC function being enabled, the intubation
icon ,TRC and Tube size are displayed.
(3) Patient type/Inspiratory trigger prompt area
The current Patient type (Adult or Pediatric) is prompted. Inspiratory trigger icon is .The icon
prompts for 1 s.

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(4) Alarm message area

Current alarm message is displayed. When there are several alarm messages, the system will display the
number of alarms. At this moment, if you click this alarm message prompt area, you can view the current
alarm message, the time of alarm occurrence, the alarm duration, and alarm level in the interface opened.
(5) Prompt message area
Current prompt message is displayed.
(6) Inactive alarm prompt area
When the icon is displayed, this suggests that an alarm existed recently but the alarm condition
disappeared. Recent alarms (up to 10 alarms can be displayed) can be viewed in the interface opened
after clicking the icon. Recent alarms can be cleared by selecting the [Reset] button.
(7) Freeze button
(8) Alarm audio paused prompt area

When the icon for 120 sec alarm audio paused countdown is displayed, this suggests that an alarm
exists at the moment, and the alarm sound is in paused state.
(9) Power status icon area
Status of power used in the present system is displayed.
(10) System time area
The current system time is displayed.
(11) Screenshot button
(12) Soft keys area
Alarm setup, Tools, O2↑Suction, Nebulizer, History, Lock, Setup and Standby buttons is displayed.
(13) Parameter setup quick keys area
Ventilation set parameter corresponding to the ventilation mode is displayed.
(14) Ventilation mode setup area
Buttons for Ventilation mode setting is displayed.
(15) Waveforms/Spirometry/Values/BigNumeric
Waveforms, Spirometry loops, measured values or Big Numeric is displayed. When the measured value
is invalid, there is no numerical display, and the horizontal line is displayed.

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4.2 Waveform Interface

Select the [Waveforms] button on the screen, and enter the interface as shown in the figure below.

4.3 Spirometry Interface

Select the [Spirometry] button on the screen, and enter the interface as shown in the figure below.

The Lung function loops can reflect the patient's pulmonary function and ventilation, including the pulmonary
compliance, whether the lungs are over-inflated, whether there is any leakage in the respiratory system and
whether the airway is occluded. It has a crucial clinical significance.

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4.3.1 Set the Loop Type

The system provides three types of spirometry loops: [P-V] (Paw-Volume) loop, [F-V] (Flow -Volume) loop,
and [F-P] (Flow -Paw) loop. Data sources of [P-V]/ [F-V]/[F-P] loop are waveform data of pressure, flow and
volume. When mainstream CO2 module is configured, [V-CO2] curve will be displayed
Up to 2 types of loops can be displayed at the same time. You can select the loop required to be displayed by
the following methods:
1) Select [Spirometry] on the main screen.
2) Select [Spirometry 1] or [Spirometry 2], and set the loop or V-CO2 curve to be displayed as required.

4.3.2 Set the Reference Loop

The ventilator is equipped with Reference Loop function. Below are the settings:
 Select [Save Ref.] button, the loop of current respiratory period can be saved as reference loop, and the
saving time will be displayed.
 Select [Display Ref.] button, and select certain time, then the reference loop saved in the time.
 Select [Display Ref.] button, and select [Close], then the reference loop being displayed can be hidden.
 Select [Review Ref.] button to enter the Loop Review interface.
Reference loops of up to 5 times can be saved in the ventilator. When reference loops of 5 times have been
saved, select [Save Ref.] button again, the system will clear the oldest reference loop and save the loop of
current respiratory period as reference loop.

4.3.3 Reference Loop Review Interface

(1)

(2)
(4)

(3)
(1) Small loop window: these small graphic windows displays reference loop. Reference loops (5 at
maximum) are displayed from the earliest (left) to the latest (right). Information on the selected reference
loop will be highlighted in cyan.
(2) Big loop window: the graphic window displays the enlarged view of the selected reference loop.
(3) Loop type: used to select the loop type to be reviewed, including P-V, F-V, F-P and V-CO2. P-V is

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selected by default.
(4) Parameter data area: monitoring parameter data related to the reference loop saved is displayed.

4.4 Measured Values Interface

When configuring the CO2 module or SpO2 module, select the [Values] button on the screen, and enter the
interface as shown in the figure below.

4.5 BigNumeric Interface

Select the [BigNumeric] button on the screen, and enter the interface as shown in the figure below.

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4.5.1 Set display parameters

On the interface select a parameter name in certain parameter area, and select parameter displayed in this area
in the parameter list popped up.

4.5.2 Setting the PulmoView

The PulmoView is used to reflect the current state of the lungs, and the expansion and contraction of the lungs
indicate the process of inhalation and exhalation. When inhaling, the lungs expand. When exhaling, the lungs
contract. The characteristics of lung resistance, compliance, and tidal volume can be visually displayed
according to the shape of the lung. Its detailed features are as follows:
 The compliance is too large, the alveolar contour becomes thinner;
 The compliance is small, and the alveolar outline becomes thicker;
 The impedance is too large, and the side line of Tiida becomes thicker;
 Excessive ventilation, the dotted line is within the alveolar outline;
 The ventilation is too small, and the dotted line is outside the alveolar outline;
The PulmoView display is as follows:

(1)

(2)

(3) (5)

(4) (6)

(1) Normal lung (2) Patient trigger (Diaphragm)

(3) Resistance (Inspiration Resistance) (4) Spontaneous Frequency
(5) Compliance (Static Compliance) (6) Spontaneous Minute Volume

Select the button, set [Ref. Compliance] and [Ref. Resistance] in the menu opened. There are three
parameter setting methods:
 Select the parameter setting area, and directly edit.
 After selecting [Restore Defaults] button, the default value corresponding to current patient type will be
loaded automatically by the system.
 Select [Use Current] button to use the Compliance Monitoring Value and Resistance Monitoring Value
displayed in current interface.

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4.6 Historical Data

Select [History] button on the screen to enter the Historical Data interface. In the interface, Tabular Trend,
Graphic Trend, Setting Trends and Event Logbook can be viewed.

4.6.1 Icon Navigation

Button Function

The cursor moves across one page in the direction of the arrow.

The cursor moves across one page in the direction of the arrow.

Previous event The cursor moves to previous event from the current event.
Next event The cursor moves to next event from the current event.

4.6.2 Graphic Trend

The Graphic Trend is used to record the change trend of parameter values at the corresponding time. It uses a
curve to describe changes in parameter measurement results, and each point on the curve corresponds to the
value of physiological parameter at each time point. The Graphic trend can be used to record the parameter
alarm event. If resolution is not set, trend data will be displayed at an interval of 1 minute by default.

(1)

(2)

(3)

(1) Current cursor. Relevant time is displayed above the cursor. If there is an alarm triggered at the time,

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relevant alarm information will be displayed above the cursor.

(2) Parameter data corresponding to the time suggested by the cursor.

(3) Event marking. The dotted line with color suggests a parameter alarm event occurs at this point in time.
The parameter alarm event is marked with the color corresponding to relevant alarm level. The color
corresponding to the highest alarm level will be used to mark when there are multiple events.

4.6.2.1 About Graphic Trend

 The horizontal axis of the Graphic trends displays the date/time.

 The vertical axis of the Graphic trends displays the parameter value.
 In the Graphic trends, the latest data is displayed at the right end.
 Trend data in standby status will not be saved by the system.
 Trend data during 72 consecutive hours can be recorded by the system
 If certain parameter triggered an alarm during the trend recording process and parameter record
corresponding to the alarm can be founded, then the parameter data will be marked in the color
corresponding to the alarm level. And it can be searched out quickly by clicking [Previous Event]/[Next
Event].

4.6.2.2 Interval

You can set the [Interval] to [5min], [10min], [15min], [30min], [1h], and [2h] in Graphic Trend interface.

4.6.2.3 Display Group

In Graphic Trend interface, you can set [Display Group] to [Pressure], [Volume], [Time], [Gas], [SpO2],
[Other] and [All].

4.6.3 Tabular Trend

In Tabular Trends interface, you can check the patient's monitoring parameter data and events. If the Interval
is not set, the trend data will be displayed at an interval of 1 minute by default. The unit of each parameter is
the same as the monitoring values setting.
The tabular trends could display the time of activating standby as well as the start of ventilation.

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Parameter

4.6.3.1 About Tabular Trends

 The horizontal axis of the Tabular Trends displays the date/time.

 The vertical axis of the Tabular Trends displays the parameter value.
 In the Tabular Trends, the latest data is displayed at the right end.
 Trend data in standby status will not be saved by the system.
 Trend data during 72 consecutive hours can be displayed by the system.
 If certain parameter triggered an alarm during the trend recording process and parameter record
corresponding to the alarm can be founded, then the parameter will be marked in the color corresponding
to the alarm level. And it can be searched out quickly by clicking [Previous Event]/[Next Event].

4.6.3.2 Interval

You can set the [Interval] to [1min], [5min], [10min], [15min], [30min], [1h] and [2h] in Tabular Trends
interface.

4.6.3.3 Display Group

In Tabular trends interface, you can set [Display Group] to [Pressure], [Volume], [Time], [Gas], [SpO2],
[Other] and [All].

4.6.4 Setting Trends

Setting Trends are used to record Ventilation Mode Setup, Ventilation Parameters Setup.

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4.6.4.1 About Setting Trends

 The horizontal axis of the Tabular Trends displays the date/time.

 The vertical axis of the Tabular Trends displays the ventilation mode and parameter value.
 In the Setting Trends, the latest data is displayed at the right end.
 Up to 8000 records can be stored in the system.

4.6.5 Event Logbook

Event log is used to record Power on/off, Ventilation Mode Setup, Ventilation Parameters Setup, Technical
Alarms (alarm information, priority, the associated alarm limits and the date and time of the occurrence) ,
Physiological Alarms(alarm information, priority, the associated alarm limits and the date and time of the
occurrence), Standby, Start Ventilation, New Patient, Special Function, Default Values Management,
Calibration, System check, ,oxygen therapy event and Alarm Audio Paused Event.

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4.6.5.1 About Event Logbook

 The latest record is displayed on top in Event log.

 Up to 8000 records can be stored in the system.
 The event log is maintained when the alarm system or the ventilator is powered down, or experienced a
total loss of power.

Note
 Up to 8000 records can be stored in the system. When exceeding 8000, the earliest record will
be overwritten by the latest event.

 Do not permit the healthcare professional operator to erase or modify the contents of the alarm
system log.

4.6.5.2 Filter

In Event Logbook interface, you can set [Filter] to [High Alarms], [Med Alarms], [Low Alarms], [All alarms],
[Operation] or [All Events].

4.7 Freeze

The Freeze function is used to suspend the real-time refresh of waveforms and spirometry loops data on the
screen. It allows short-time review of patient data so that you can carefully observe the patient’s condition
within this period. Data reviewed is the waveforms and spirometry loops 2 min before entering freeze state.

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4.7.1 Enter Freeze State

In non-standby and non-freeze state, click the [Freeze] button “ ”, the screen will prompt [It is freeze. Press
the Freeze button again to unfreeze.]. When the system enters freeze state, the freeze cursor will appear in the
area around the waveform/loop. All waveforms and loops are freeze, namely waveforms and loops will not be
refreshed. Data in parameter area can be refreshed properly. In freeze state, the Save Reference Loop button is
unavailable, so you can’t save the reference loop, but you can view the reference loops that have been saved.

4.7.2 Waveforms Review

In freeze state, the cursor appears around the waveform. You can move the cursor to review the waveform via
the touchscreen or rotate the main control knob clockwise or counterclockwise.

4.7.3 View the Loop

In freeze state, the cursor appears around the loop. You can move the cursor to view the loop via the
touchscreen or rotate the main control knob clockwise or counterclockwise.

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4.7.4 Exit Freeze State

In freeze state, click the [Freeze] button “ ” to exit from freeze state. If no operation is performed on the
ventilator within 3 minutes after entering freeze state, the system will exit from freeze state automatically.

4.8 Lock Screen

After clicking the “ ” button on the screen, the ventilator will enter locked state. It will prompt [Screen
locked. Press the Lock key to unlock screen.] in prompt message area. In locked state, only the “ ” button
on the panel, [O2↑ Suction] and “ ” button are valid, while the touchscreen, main control knob and other
buttons are invalid. Click the “ ” button to unlock.

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 Chapter 5 Basic Operations

5.1 Display Setting

5.1.1 Waveform Setting

1) Select [Setup] → [Setting] → [Waveform].

2) Set [Waveform Count] as required by selecting the number of waveforms to be displayed.
3) Select [Draw Wave] and toggle between [Curve] and [Fill].
 Curve: the waveform is displayed as a curved line.
 Fill: the waveform is displayed as a filled area.
4) Set the color of waveform and parameter to be displayed.
5) Select the parameter name in waveform area, and set the waveform to be displayed in the dialog box
popped up.

5.1.2 Colors

The color of Waveform, Parameter, Loop and Parameter alarm limit are associated, in which the color of
Waveform and Parameter are settable. As soon as the color of Waveform or Parameter is set, the color of the
associated parameter, waveform or loop will change. The associated alarm limit will be displayed in dark
color of the color set.
See the table below for Waveform, Parameter associated with waveform, Loop associated with waveform, and
Alarm associated with waveform:
Waveform related Waveform related
Waveform Waveform related parameters
spirometry loop alarm limits
Airway Pressure Ppeak, Pmean, Pplat, PEEP P-V loop, F-P loop Paw
Flow MV, MVleak, MVspn, TVe, TVi, TVspn, F-V loop MV, TVe, ftotal
ftotal, fmand, fspn, TVe/IBW
Volume / / /
/ FiO2 / FiO2
CO2 EtCO2, Vdaw, VDaw/TVe, Vtalv, V’alv, V-CO2 loop EtCO2
SlopeCO2, V’CO2, VeCO2, ViCO2
Pleth SpO2, PR, PI / SpO2, PR

5.1.3 Defaults

1) Select [Setup]→[Setting]→[Waveform].
2) Set [Defaults] as required to restore the setting values in the screen setup menu to the default values.

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 Basic Operations

5.2 Set IBW/Height

1) Select [Setup]→ [Setting] → [System].

2) Select [IBW/Height] and toggle between [IBW] and [Height]. When the ventilator is used on a new
patient, the system calculates default values of TV, f, and fapnea in the ventilation mode automatically
based on the set IBW or height and gender.

5.3 Set TV/IBW

1) Select [Setup]→ [Setting] → [System].

2) Select [TV/IBW] and set it to appropriate ratio. The system sets TV default value in the ventilation mode
based on [TV/IBW].

5.4 Set Tinsp/ I:E

1) Select [Setup] → [Setting] → [System].

2) Set [Tinsp/I:E]: [Tinsp] or [I:E]. According to [Tinsp/I:E], the Ventilation set parameters associated with
Tinsp or I:E will be applied in V-A/C, P-A/C, PRVC and DuoVent (When the time parameter for
DuoVent is [f]) ventilation mode.

5.5 Set DuoVent Time Parameter

1) Select [Setup] → [Setting] → [System].

2) Set [DuoVent Setup]: [Thigh] or [f]. If the item is set to High Pressure Time, time control parameters in
DuoVent ventilation mode are [Thigh] and [Tlow]. If the item is set to [f], and [Tinsp/I:E] is set to
[Tinsp], time control parameters in DuoVent ventilation mode are [f] and [Tinsp]. If the item is set to [f],
and [Tinsp/I:E] is set to [I:E], time control parameters in DuoVent ventilation mode are [f] and [I:E].

5.6 Set Invasive Apnea Mode

1) Select [Setup] → [Setting] → [System].

2) Set [Invasive Apnea Mode]: [Volume Control] or [Pressure Control]. While performing invasive
ventilation, if the item is set to [Volume Control], the settable control parameter in Apnea ventilation
mode is [TVapnea]; if the item is set to Pressure Control, the settable control parameter in Apnea
ventilation mode is [△Papnea].

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5.7 Set Oxygen Sensor Monitoring

1) Select [Setup] → [Sensor] → [O2].

2) Set [Monitoring]: On or Off. When it is turned on, it indicates that the patient's inspired oxygen
concentration can be monitored. If you do not need to use the oxygen concentration monitoring function
you can turn off the oxygen concentration monitoring switch. At the moment, a prompt message saying
[O2 Monitoring Off] will appear on the screen.

CAUTION
 Disabling the Oxygen Concentration Monitoring function is permissible. However, to prevent
the patients from potential harm after disabling the monitoring and alarming function, we
recommend that you do not disable the Oxygen Concentration Monitoring function
continuously.

Note
 Total system response time for the Oxygen Concentration Monitoring is 23s.

 It takes about 3 minutes from powering on the ventilator to performing the monitoring
performance as specified of Oxygen Concentration Monitoring in Appendix of this manual.

5.8 Set Language

1) Select [Setup] → [Maintain] → input the User maintenance password to enter the [User] menu.
2) Select [Settings] → [Language], and set the language as required.
3) Reboot the ventilator to put the language selected into effect.

5.9 Set Unit

1) Select [Setup] → [Maintain] → input the User maintenance password to enter the [User] menu.
2) Select [Settings] → set [Unit].
 [Weight Unit]: kg or lb.
 [Paw Unit]: cmH2O, hPa or mbar.
 [CO2 Unit]: mmHg, kPa or %.
 [f Unit]: /min or bpm.

5.10 Set O2 Supply Type

1) Select [Setup] → [Maintain] → input the User maintenance password to enter the [User] menu.

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 Basic Operations

2) Select [Settings] → [Gas Supply].

3) Set [O2 Gas Supply Type]: HPO or LPO. It’s used to set the Gas Supply type.

5.11 Set Screen Brightness

1) Select [Setup] → [Setting] → [Brightness/Volume ].

2) Select [Screen Mode] to [Day] or [Night], the default screen brightness will be adjusted accordingly.
3) If you are dissatisfied with screen brightness, you can also directly set [Brightness]: 1～10. 1 is for the
darkest level and 10 for the brightest. When using battery power supply, you can set the brightness at a
lower level so as to save the battery's power.

5.12 Set Key Volume

1) Select [Setup] → [Setting] → [Brightness/Volume].

2) Set [Key Volume]: 0～10. Select 0 to mute the key volume, 10 to set the loudest level.

5.13 Set Time and Date

1) Select [Setup] →[Setting]→[Date/Time].

2) Set [Date Format]: [YYYY-MM-DD], [MM-DD-YYYY], or [DD-MM-YYYY].
3) Set [Time Format]: [24h] or [12h].
4) Set [Time] and [Date].

5.14 View System Information

5.14.1 Version Information

1) Select [Setup] → [Maintain] → input the User maintenance password to enter the [User] menu.
2) Select [Syst. Info] → [Version] to query software version information of the system.

5.14.2 Configuration Information

1) Select [Setup] → [Maintain] → input the User maintenance password to enter the [User] menu.
2) Select [Syst. Info] → [Config Info.] to query configuration information of the ventilator, e.g. ventilation
mode.

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5.14.3 Maintenance Information

1) Select [Setup] → [Maintain] → input the User maintenance password to enter the [User] menu.
2) Select [Syst. Info] → [Maintain] to query System Total Running Time, System Startup Time, O2 Sensor
Last Calibration Time, Flow Sensor Last Calibration Time, Time left for the next blower maintenance,
Time of Last Maintaining.

5.15 Manage Default Settings

The ventilator has the following set values:

 The factory default values, namely the set values preset by the factory. The default values can be divided
into 2 groups (Adult and Pediatric) by patient type. The Pediatric mode is applied to both pediatric and
infant.
 Current set values. Adjust the ventilator settings as per actual need, and save the setting as current set
values. The set values can be divided into 2 groups (Adult and Pediatric) by patient type.
 The latest set values. The operator may change some settings in the practical application. Those changes
could not necessarily be saved as current set values. The set values are saved in a real-time manner by the
ventilator. The set values saved is the latest set values.

5.15.1 Save and Load Current Settings

Adjust the ventilator settings as per actual need, and save the setting as current set values.
1) Select [Setup] → [Maintain] → input the User maintenance password to enter the [User] menu.
2) Select [Defaults] → [Use Current] to save the current set values.
When applied to new patient after startup, the ventilator will load the set values saved automatically.

5.15.2 Restore Factory Default Settings

While the ventilator is in use, you can restore it to factory default settings manually.
1) Select [Setup] → [Maintain] → input the User maintenance password to enter the [User] menu.
2) [Defaults] → [Restore Default] button, restore it to factory default settings.
When applied to new patient after startup, the ventilator will load the factory default values automatically.

5.15.3 Restore the Latest Set Values

When the ventilator is applied to the same patient after startup, the system will adopt the latest set values
automatically.

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Note
 Records automatically saved by the system are as follows: Reference Loop, Monitoring Trends,
Event Logbook (Including Alarm Log), Trends Setting, the Measured Value of Special
Function (Including the Measured Value of PEEPi, NIF, P0.1 and P-V Tool), Patient Setting,
Device Setting and Alarm Setting. The data changed will be stored in flash memory chip of
motherboard. The data will be recovered automatically when restarting the device.

5.16 Data Transfer

While the ventilator is in use, you can export/import the setting items.
Set Export:
1) Insert the USB memory into USB connector of the ventilator.
2) Select [Setup] → [Maintain] → input the User maintenance password to enter the [User] menu.
3) Select [Data Transfer] →[Setting] → [Export], save the current settings and default values in the
ventilator to the USB memory.
Set Import:
1) Insert the USB memory into USB connector of the ventilator.
2) Select [Setup] → [Maintain] → input the User maintenance password to enter the [User] menu.
3) Select [Data Transfer] →[Setting] → [Import], load the settings in the USB memory to the ventilator.

5.17 Data Export

Data export function means the ventilator exports some data to the USB memory.

5.17.1 Screen Export

Screen export function means the ventilator exports screenshots saved recently. The file format exported is
png.
Operating steps for Screen export are as follows:
1) Insert the USB memory into USB connector of the ventilator.
2) Select [Setup] → [Export] → [Export Screenshot], the system will check whether the USB memory
exists or not. If the USB memory exists with enough free space, the system will export the interface
saved by the device.
3) After the export is finished, select [Remove USB] button to remove the USB Memory.

5.17.2 Data Export

Data Export means the ventilator exports Patient information, Current Alarm Limit, Trend, etc.

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Operating steps for data export are as follows:

1) Insert the USB memory into USB connector of the ventilator.
2) Select [Setup] → [Export] → [Export Data], the system will check whether the USB memory exists or
not. If the USB memory exists with enough free space, the system will export patient information,
current set parameter, current alarm limit, tabular trends, graphic trends, and the measured value of
PEEPi/P0.1/Vtrap/NIF, etc. The file format exported is html.
3) In addition to exporting the data above, if you need to export Event log, Self-test log and more, select
[Setup] → [Maintain]→ input the User maintenance password → [Data Transfer] → [Data] → select
data type to be exported → [Export], the system will check whether the USB memory exists or not. If the
USB memory exists with enough free space, the system will export the data. The file format exported is
html.
4) After the export is finished, select [Remove the USB memory] button to remove the USB memory.

Note
 After power-down, the data could be stored no matter how long it is. The time of device
power-down is also recorded.

5.18 Power Failure Alarm

The ventilator provides Power failure alarm function. When the ventilator is in normal use, if the AC and DC
power cord comes off accidentally or is unplugged from the ventilator, without battery installed or battery
depletion, the device will provide an alarm sound through buzzer only and would last for at least 120s. Its
feature: High level alarms: Di---. In this case, there are no alarm indicators nor LCD displayer.

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 Chapter 6 Alarms

An alarm is a prompt sent by the ventilator to medical workers in sound, light or other forms when the
operator ventilator cannot smoothly use the ventilator due to abnormal changes of the patient’s vital signs or
failure of the ventilator.

6.1 Safety Precautions

WARNING
 Users should set the alarm volume and the alarm limit according to the patent’s actual
condition. Do not monitor the patient only by relying on the sound alarm system. The patient
may be put in a dangerous situation if the alarm volume is low. Set the minimum alarm volume
should be higher than environmental noise. Users should pay close attention to the patient’s
actual clinical condition.

 The physiological waveforms, physiological parameters, alarms and other information

displayed on the screen of the equipment are only for reference to doctors, which shall not be
used as a basis for clinical treatment.

 A hazard can exist if different alarm presets are used for the same or similar equipment in any
single area, e.g. an intensive care unit or cardiac operating theatre. The operator should check
that the current alarm presets is appropriate prior to use on each patient.

 No matter how long the power loss, after the restoration of supply mains, the equipment would
restore to the last settings used. When start-up, the main menu is keep at the [New Patient]
page, you could select [last patient] to retained alarm settings from previous use, or select the
new patient type for new operation. Upon change of patient type, the ventilation parameter and
alarm limit would restore to default pre-set.

Note
 The system will test whether the alarm sound and alarm light function normally at start-up.
Normally, the equipment will sound one “beep” for alarming and the alarm light will blink
yellow and red once respectively. If the alarm sound and alarm light function abnormally, do
not use this equipment and contact us immediately.

 When several alarms of different levels are generated simultaneously, the equipment will give
light and sound alarms according to the highest priority alarm among all alarms.

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 Alarms

6.2 Alarm Type

Alarms generated by the ventilator are classified into physiological and technical alarms by the nature of
alarm.
 Physiological alarm
A physiological alarm is often generated when a certain physiological parameter of the patient is beyond
the upper/lower alarm limit or the patient has physiological disorder. A physiological alarm message is
displayed in the alarm area in the upper part of the screen.
 Technical alarm
A technical alarm is also known as a system error message, which is an alarm triggered when a system
function cannot work normally or the monitoring result is distorted due to improper operation or system
failure. A technical alarm message is displayed in the alarm area in the upper part of the screen.
Apart from physiological and technical alarms, the ventilator will show some messages related to system
status. These messages generally do not involve vital signs of the patient, and are shown in the system prompt
message area as prompt messages.

6.3 Alarm Level

 High-level alarm: The patient is in critical condition or the device has serious failure, and immediate
response is necessary
 Medium-level alarm: The patient’s physical signs are abnormal, the device has failure or is misoperated
by the user, and timely response is necessary
 Low-level alarm: The patient feels unwell, the device has failure or is misoperated by the user, and the
user is required to understand the current situation

6.4 Alarm Mode

6.4.1 Light Alarm

The alarm indicator lights will indicate different levels of alarms generated in different colors and blinking
frequencies.
 High-level alarm: Red, flash frequency: 1.65 Hz.
 Medium-level alarm: Yellow, flash frequency: 0.55 Hz.
 Low-level alarm: Yellow, no blinking, light remaining on.

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 Alarms

6.4.2 Sound Alarm

Sound alarms concerning for different levels of alarms generated by the ventilator with different sound
characteristics.
 High-level alarm: beep-beep-beep--beep-beep----beep-beep-beep--beep-beep
 Medium-level alarm: beep-beep-beep
 Low-level alarm: beep
When supply mains and battery both loss, the ventilator will provide an alarm sound through buzzer only and
would last for at least 120s, with sound characteristics:
 High level alarms: Di---
Sound alarm signal A weighted sound pressure level:
 Operator position: 1 m in front of the ventilator, and at the height of 1.5 m.
 A-weighted sound pressure level: not less than 45 dB, not greater than 85 dB with adjustable alarm
volume; at the manufacturer default alarm volume level, the alarm volume of high-priority alarm is not
less than 60 dB.

6.4.3 Alarm Message

An alarm message is the message shown in the alarm area when an alarm is generated.
The following signs are used in front of alarm messages to differentiate the levels of alarm messages:
 High-level alarm: ！！！
 Medium-level alarm: ！！
 Low-level alarm: ！
Ground colors corresponding to different levels of alarm messages:
 High-level alarm: Red
 Medium-level alarm: Yellow
 Low-level alarm: Yellow

6.4.4 Alarm parameter form

 High-level alarm: red background, blinking, parameter constant (on)

 Medium-level alarm: yellow background, blinking, parameter constant (on)
 Low-level alarm: yellow background, blinking, parameter constant (on)

6.4.5 Alarm State Icons

: This suggests that an alarm existed recently but the alarm condition disappeared. Recent alarms (up to 10
alarms can be displayed) can be viewed in the interface opened after clicking the icon. Recent alarms can
be cleared by selecting the [Reset] button.

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 Alarms

: Indicates the alarm system is in audio paused state.

: Indicates the alarm is off.
: Indicates there are multiple alarm messages when the number of alarms is displayed before the alarm
message. Red indicates the highest level of multiple alarm messages is high-priority. Yellow indicates
the highest level of multiple alarm messages is medium-priority. Click the alarm message prompt area at
the moment to view the current alarm.

6.5 Set Alarm Limit of Parameters

WARNING
 When setting the upper/lower limit value of alarm limit of parameters, make sure they are
appropriate for the patient type before use.

 After each change of ventilation parameters, please check the alarm limits are valid and
appropriate for the patient’s condition.

 When the alarm limit is enabled, after manually setting the upper/lower limit value of alarm
limit, the device will display these upper/lower limit values set instead of displaying the initial
alarm limit values preset by the system.

 After powering off accidentally while the device is in use, when the device is rebooted, settings
before the power interruption will be auto loaded.

 When setting alarm limits to extreme values, the alarm system may be useless.

CAUTION
 If the high-pressure alarm limit needn’t be set greater than 60cmH2O as per clinical condition,
it’s recommended to set it to 60cmH2O or lower to extend the service life of the blower and the
battery life.

 When the airway pressure setting exceeding 60cmH2O, a deliberate action is needed, you would
see prompt message of [ΔPinsp+int.PEEP+PEEP>60cmH2O? Press the control knob to
confirm] before continuing your adjustment.

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 Alarms

Note

 When a parameter value is greater than the upper alarm limit or less than the lower alarm
limit, an alarm will be triggered.

 During use of the equipment, always pay attention to whether the alarm limits of each
parameter are set to proper values.

6.5.1 Set SpO2 Limit

1) Select [Alarm] → [Limit 1], [Limit 2] or [SpO2].

2) Set the alarm s according to the patient’s condition.

6.5.2 Set Auto Alarm Limit

The ventilator provides function of setting alarm limit automatically. It sets alarm limit automatically
according to current patient type and parameter values measured.
Before using these alarm limits, ensure whether they are fit for current patient. If not, you need to set the
alarm limit manually.
Alarm limit Formula
Paw High limit Average Ppeak + 10cmH2O or 35cmH2O, whichever is larger.
MV High limit 1.5 × MV monitored value
MV Low limit 0.6 × MV monitored value
TVe High limit 1.5×TVe average value
TVe Low limit 0.5×TVe average value
ftotal High limit 1.4×ftot monitored value
Tapnea 15s

Mean value in formula: use the monitored value in the last 8 ventilation cycles or the monitored value in 1
minute as Mean value, whichever is smaller.
If the alarm limit figured out is greater than the high threshold of setting range, or less than low threshold,
relevant threshold will be used as Auto alarm limit.
The steps to set the automatic alarm limit are as follows:
1) Select [Alarm] → [Limit 1].
2) Select [Auto Limits].

Note
 When the factory configuration is used, relevant alarm limit of parameters will change. See
“Appendix IV Default Settings” for details.

 CO2 and SpO2 alarm limit don’t have the function of setting auto alarm limit.

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 Alarms

6.6 Set Alarm Volume

6.6.1 Set Minimum Alarm Volume

Do not set the minimum alarm volume too low; otherwise you cannot hear the alarm sound. This may put the
patient safety into danger. Follow the steps below to set the minimum alarm volume:
1) Select [Setup] →[Maintain], input user maintain password.
2) Select [Settings] →[Other].
3) Set [Minimum Alarm Volume].

Note
 When the alarm volume is too low, the alarm sound may be hard to be heard. Set the minimum
alarm volume should be higher than environmental noise.

6.6.2 Set Alarm Volume

1) Select [Alarm] → [Audio].

2) Set [Alarm Volume]. The range of Alarm volume is X～10. X represents the lowest volume, which
depends on the setting of minimum alarm volume. If there is no alarm triggered, you can select [Test],
the system will play the high-priority alarm sound once as per the volume you set.

Warning
 In the process of using the equipment, do not only rely on the sound alarm system. The patient
may be put in a dangerous situation if the alarm volume is low. Do set the minimum alarm
volume higher than environmental noise, otherwise, it could impede operator recognition of
alarm conditions. Users should pay close attention to the patient’s actual clinical condition.

6.7 Alarm Audio Paused

In the alarm process, click alarm audio paused button on the panel to enter the [Alarm Audio Paused],
the alarm sound currently produced can be turned off. After a countdown for 120 sec audio paused countdown,
the sound alarm will be restored.
Alarm audio paused can be canceled in the following cases:
 When 120 sec audio paused countdown finished.
 When conditions for the alarm sound currently produced disappeared.
 In [Alarm Audio Paused], press the button on the panel.

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 Alarms

WARNING

 During alarm audio paused, pay close attention to the actual clinical condition of patient and
the ventilator to ensure that no alarm message is ignored. If the alarm condition continuously
exists without taking measures, harm can be caused to the patient or the equipment.

Note
 In [Alarm Audio Paused], all alarm signals except auditory alarm signals can work normally.

6.8 Recent Alarm

When there are active alarms in the system, if the number of alarms is displayed before the alarm message,
this indicates there are multiple alarm messages. At this moment, if you click this alarm message prompt area,
you can view the current alarm message, the time of alarm occurrence, and the alarm priority in the Recent
Alarm menu opened. Up to 10 alarms can be displayed.

After all active alarms are cleared, the icon will be displayed. Inactive recent alarms (up to 10 alarms can

be displayed) can be viewed in the Recent Alarm menu opened after clicking the icon . Inactive recent
alarms can be cleared by selecting the [Reset] button.

6.9 Alarm Off

When Paw low alarm limit, TV high alarm limit, TV low alarm limit , ftotal high alarm limit or low alarm

limit are set to [OFF], the system will display the alarm off icon “ ” in the Alarm limit of parameters area,
the relevant physiological alarms [Paw Too Low], [TVe Too High], [TVe Too Low], [ftotal Too High] or
[ftotal Too Low] will be turned off. Namely, the sound, light, text display and alarm blinking on the alarm
will be terminated.

WARNING
 When the alarm is disabled, if an alarm is generated, the device cannot trigger an alarm
condition. Therefore, operators shall use this function carefully.

6.10 Set Nurse Call

Nurse Call function means when the alarms set by users are triggered, the ventilator can input signal to Nurse
Call System to call a nurse. The ventilator provides Nurse call interface, which can realize “Nurse Call”

6-7
 Alarms

function after connecting the ventilator with the Nurse call system of the hospital using the Nurse call cable
supplied with the device.
Nurse Call function will be triggered when the ventilator meets the following conditions.
 Nurse call function is [On].
 There are alarms which meet user's settings generated.
 The system is not [Alarm audio paused] or [Reset].

Setup steps for Nurse call:

1) Select [Setup]→ [Maintain] → input the User maintenance password to enter the [User] menu.
2) Select [Interface]→ [Nurse Call].
3) Switch on/off
4) Select [Signal Type] to set the signal type of Nurse call:
 [Pulse]: Nurse call signal output is the pulse signal lasts 1s. When there are multiple alarms, only 1
pulse signal will be output; when a new alarm is generated with the current alarm being not
removed, a pulse signal will be output again.
 [Continuous]: The Nurse call signal output lasts as long as the time the alarm exists, namely lasts
from the alarm happening to the alarm terminating.
5) Select [Contact Type] to set working mode for the relay of Nurse Call System to [Normally Closed] or
[Normally Open].
6) Select [Alarm Level] to set the alarm level in which the nurse call can be triggered. If no choice is made,
any alarm will not trigger the nurse call.
7) Select [Alarm Type] to set the alarm type which will trigger the Nurse call. If no choice is made, any
alarm will not trigger the nurse call.

WARNING
 Nurse call function shall not be used as main alarm messages source. Sound alarm and visual
alarm must be combined with the patient’s clinical presentation and symptoms.

 Use the nurse call cable supplied by us to connect the nurse call interface with the nurse call
system of the hospital, otherwise this may lead to machine burnt and electric shock.

 When using Nurse Call function, regular check shall be performed on the ventilator’s alarm
signal.

 The Nurse Call System is required to meet the relevant IEC/ISO standard, with at least
2MOOP isolation from supply mains power supply. Under normal condition and single fault
condition, the maximum voltage accessible shall not exceed the rating.

6.11 Alarm Tests

The alarm system will perform a self-test on alarm light/sound at start-up.

Self-test phenomena:

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 Alarms

 The alarm indicator blinks in yellow-to-red sequence once and turns off.
 While the alarm indicator is preforming self-test, the alarm system sound one “beep” of alarm sound to
perform alarm sound self-test.
To perform further check on the alarm system, use the relevant simulator to measure and check. Adjust the
alarm limit to check whether correct alarm response can be triggered.

6.11.1 Battery in Use

1) After the ventilator is connected to AC power supply, press On/Off button.

2) After the system is started, disconnect the AC power.
3) Verify whether the [Battery in Use] alarm is triggered, and the ventilator is powered by the battery.
4) Reconnect AC Power Supply
5) Verify whether the alarm is reset automatically, and the ventilator is powered by AC Power supply.

6.11.2 Power Failure Alarm

1) After the ventilator is connected to AC power, press On/Off button.

2) After the system is started, disconnect the external power supply when the battery is fully charged.
3) When the ventilator is connected to test lung, the ventilation is normal.
4) For the ventilator equipped with 1 battery, the ventilation time is about 2 hours (For the ventilator
equipped with 2 batteries, the ventilation time is about 4 hours). When the battery capacity is running out,
the Power failure alarm [System DOWM. Connect Ext. Power.] will be triggered.
5) Reconnect External Power Supply
6) Verify whether the alarm is reset automatically, and the ventilator is powered by external power supply.

6.11.3 Paw Too High

1) After the ventilator system is started normally, connect the ventilator to test lung and start ventilation.
2) Set Paw high alarm limit to current Ppeak + 5cmH2O.
3) In the inspiratory phase, press hard on the test lung.
4) Verify whether the [Paw Too High] alarm is triggered, the respiratory cycle is in expiratory phase, and
airway pressure is reduced to PEEP value.

6.11.4 Paw Too Low

1) After the ventilator system starts normally, connect the ventilator to the splint lung and start ventilation.
2) Set Paw low alarm limit to current Ppeak + 5cmH2O.
3) Verify that the [Paw Too low] alarm is activated

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 Alarms

6.11.5 TVe Too Low

1) After the ventilator system is started normally, connect the ventilator to test lung and start ventilation.
2) Set the TV low alarm limit to greater than current TVe, and verify whether the [TVe Too Low] alarm is
triggered.

6.11.6 TVe Too High

1) After the ventilator system is started normally, connect the ventilator to test lung and start ventilation.
2) Set the TV high alarm limit to less than current TVe, and verify whether the [TVe Too High] alarm is
triggered.

6.11.7 MV Too Low

1) After the ventilator system is started normally, connect the ventilator to artificial lung and start
ventilation.
2) Set the MV low alarm limit to greater than current MV, and verify whether the [MV Too Low] alarm is
triggered.

6.11.8 MV Too High

1) After the ventilator system is started normally, connect the ventilator to the splint lung and start
ventilation.
2) Set the MV High alarm limit to be less than the current minute ventilation, and verify that the alarm of
[MV Too High] is activated.

6.11.9 O2 Supply Failure

1) Connect he ventilator to high-pressure O2 supply.

2) Turn on the ventilator, connect the ventilator to the splint lung, set the O2 to 40vol%, and start
ventilation.
3) Turn off the high-pressure O2 supply, and verify whether the [O2 Supply Failure] alarm is triggered.

6.11.10 PEEP Too Low

1) Dismantle the expiratory valve diaphragm of the ventilator, and install the expiratory valve.

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 Alarms

Expiratory valve diaphragm

2) After the ventilator system is started normally, connect the ventilator to test lung and start ventilation.
3) Set PEEP to 5cmH2O and verify whether the [PEEP Too Low] alarm is triggered.

6.11.11 Airway Obstructed

1) After the ventilator system is started normally, connect the ventilator to test lung and set to pressure
mode, and start ventilation.
2) Disconnect the connection between Y-shaped tube and test lung, use leakage-test plug to block Y-pipe
tube.
3) After several respiratory cycles, verify whether the [Airway Obstructed?] alarm is triggered.
4) Connect Y-pipe tube with test lung, and verify whether the alarm is reset automatically.

Note
 The maximum delay time of the technical alarm for the disconnection of the breathing circuit is
two breathing cycles.

6.11.12 Tube Disconnected

1) After the ventilator system is started normally, connect the ventilator to test lung and start ventilation.
2) Disconnect the test lung.
3) Verify whether the [Tube Disconnect?] alarm is triggered.

6.11.13 Apnea Alarm

1) After the ventilator system is started normally, connect the ventilator to artificial lung and set the
ventilator to Spontaneous Breathing mode. Ensure the Apnea spare ventilation is disabled.
2) Set [Tapnea] and wait.
3) Verify whether the [Apnea] alarm is triggered.
4) Press the artificial lung.
5) Verify whether the [Apnea] alarm is reset.

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 Alarms

6.11.14 FiO2 Too High

1) Connect the ventilator to low-pressure O2 supply, and set the O2 supply type to low-pressure O2 supply.
2) Connect the ventilator to test lung, and start ventilation.
3) After ventilation is stable, set the FiO2 high alarm limit to less than current monitored value of oxygen
concentration.
4) Verify whether the [FiO2 Too High] high-priority alarm is triggered.

6.11.15 FiO2 Too Low

1) Connect the ventilator to high-pressure O2 supply, and set the O2 supply type to high-pressure O2 supply.
2) Connect the ventilator to test lung, and start ventilation.
3) After ventilation is stable, close the high-pressure O2 supply.
4) Verify whether the [FiO2 Too Low] high-priority alarm is triggered.

6.11.16 EtCO2 Too High

1) Connect he ventilator to test lung, and start ventilation.

2) Connect the CO2 test module, and set it to working state.
3) After CO2 is preheated, supply 3% ~ 7% CO2 standard gas to the sampling port of sidestream CO2
module or the airway adapter of mainstream CO2 module, set the EtCO2 high alarm limit to be less than
the concentration of the standard gas.
4) Verify whether the [EtCO2 Too High] medium-priority alarm is triggered.

6.11.17 EtCO2 Too Low

1) Connect the CO2 test module, and set it to working state.

2) Connect he ventilator to test lung, and start ventilation.
3) After CO2 is preheated, supply 3% ~ 7% CO2 standard gas to the sampling port of sidestream CO2
module or the airway adapter of mainstream CO2 module, set the EtCO2 low alarm limit to be greater
than the concentration of the standard gas.
4) Verify whether the [EtCO2 Too Low] medium-priority alarm is triggered.

6.11.18 SpO2 Too high

1) Connect the ventilator and test lung, and start ventilation.

2) Connect the SpO2 probe, and set the SpO2 monitoring function on
3) Connect the SpO2 probe with finger, set the SpO2 high alarm limit at 20%, the high SpO2 alarm limit at
22%

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 Alarms

4) Verify that the [SpO2 Too High] alarm condition is activated.

6.11.19 SpO2 too low

1) Connect the ventilator and test lung, and start ventilation.

2) Connect the SpO2 probe, and set the SpO2 monitoring function on
3) Connect the SpO2 probe with finger, set the SpO2 low alarm limit at 98%, the high SpO2 alarm limit at
100%
4) Pinch the finger with SpO2 probe, when the % SpO2 is lower than 98%, verify that the [SpO2 too low]
alarm condition is activated.

6.11.20 PR Too High

1) Connect the ventilator and test lung, and start ventilation.

2) Connect the SpO2 probe, and set the SpO2 monitoring function on
3) Connect the SpO2 probe with index finger, set the PR high alarm limit at 30 bpm,
4) Verify that the [PR Too High] alarm condition is activated.

6.11.21 PR Too Low

1) Connect the ventilator and test lung, and start ventilation.

2) Connect the SpO2 probe, and set the SpO2 monitoring function on
3) Connect the SpO2 probe with index finger, set the PR low alarm limit at 240 bpm and the lower limits at
238 bpm. Verify that the [PR Too Low] alarm condition is activated.

6.12 Alarm Handling Measures

When the ventilator generates an alarm, take relevant measures according to the following steps:

1) Check the patient’s condition.

2) Confirm the parameters or the type of alarm being happened.
3) Identify the cause of alarm.
4) Find the solution for discharging the alarm
5) Check whether the alarm is eliminated.
For detailed measures for handling each alarm, see “Appendix V Alarm Messages”.

WARNING
 To prevent patient injury, check whether patient ventilation is sufficient when an alarm is
activated. Identify the cause of alarm and discharge the alarm. The alarm limit can be
readjusted when the alarm limit setting is inappropriate for the circumstance.

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 Alarms

Note
 If an alarm exists without any apparent cause, contact local After-sales Service Department of
Comen.

6-14
 Chapter 7 Start Ventilation

7.1 Start System

1) Plug the power cord into a power outlet. Make sure the external power indicator is on.
2) Press the On/Off button.
3) The alarm indicator flashes once in the yellow-to-red sequence, and the speaker and buzzer beeps
self-test tone once respectively. If the light and sound signals are not given, do not use this device and
contact our after-sales service.
4) The screen displays the startup screen and a self-test progress bar, and then enters the system check
interface.

Note
 During the start-up process, the system detects whether the sound and light alarm functions are
normal. If normal, the alarm indicator flashes once from red to yellow, and the speaker and
buzzer give a self-test tone respectively. If the light and sound signals are not given, do not use
this device and contact our after-sales service.

7.2 System Check

WARNING
 After each replacement of accessories/components such as a breathing tube, humidifier, or
breathing filter, the system check must be performed again to ensure the ventilator works
normally.

CAUTION
 Always run the self-test before using the ventilator on a patient. If any test fails, stop using the
ventilator immediately. Do not use the ventilator until the necessary repairs have been completed
and all tests are passed.
 Before performing the system check, disconnect the patient from the device and ensure that there
is an alternative means of ventilation to support the patient ventilation.

The path to the system check interface:

 After starting, the system automatically enters the system check interface.
 In a non-standby interface, select the [Standby] button and then confirm to enter the standby interface.
 In standby interface, select the [System Check] button to enter the system check interface.

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 Start Ventilation

In the system check interface, the time of the last system check is displayed.
Select the [Details] button to query the self-test information of the ventilator, including the items, results and
time of self-tests.
Connect the Gas Supply according to the prompt to close the Y-shaped tube and then select [Continue]. The
system will start the self-checking procedure item by item.
The test items include:
 Blower test: test the rotation speed of the blower.
 O2 flow sensor test: test the flow sensor in the O2 limb.
 Inspiratory flow sensor test: test the inspiratory valve and flow sensor.
 Expiratory flow sensor test: test the expiratory flow sensor.
 Pressure sensor test: test the pressure sensors at the inspiratory end and expiratory end.
 Expiratory valve test
 Safety valve test
 Leakage (ml/min)
 Compliance (ml/cmH2O)
 Tube resistance (cmH2O/l/s)
 O2 sensor test
The test results include:
 Passed: the test item has been completed and passed the self-check.
 Failed: the test item has been completed and failed to passed the self-check.
 Cancelled: the test item has been cancelled.
 Insufficient oxygen supply: the oxygen supply is insufficient during the O2 sensor test or O2 flow sensor
test.
 The monitoring function is off: the sensor monitoring function may be turned off during the O2 sensor
test.
During self-test, the system prompts [Testing] to the right of the current self-check item.
If you select the [Skip] button to stop running this test item, with the self-test result displayed as [Cancel]. The
next self-test item will start at the same time.
If you select the [Stop] button, the system will immediately stop running the current and all remaining test
items, with the corresponding self-test results displayed as [Cancel].
When the O2 sensor test fails, [O2 Calibration] button is displayed. Press it to open the menu for performing
O2 concentration calibration.
After all self-test items are completed, you can select [Retry] to run the self-test procedure again.
Select [Exit] to exit the self-test mode and enter the standby interface.

7.3 Select Patient

Once the self-test is completed, select [Exit] to exit the self-test mode and enter the standby interface.
You need to select a patient:

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 Start Ventilation

 If you select [Last Patient], please set the ventilation type and ventilation mode in the current interface,
and then select [Start Ventilation].
 If you select [New Adult] or [New Pediatric], set up [Gender], [Height] / [IBW], ventilation type and
ventilation mode in the current interface, and then select [Start Ventilation].

Note
 The Pediatric mode is applied to both pediatric and infant (not less than 3kg).

7.4 Ventilation Type

This ventilator supports two types of ventilation: invasive and non-invasive.

WARNING
 When switching from non-invasive ventilation to invasive ventilation, MAKE SURE to check
the alarm limit settings.

7.4.1 Invasive Ventilation

Invasive ventilation refers to the ventilation of patients through artificial airway (ET tube or Trach tube).
Invasive ventilation modes include: V-A/C, P-A/C, V-SIMV, P-SIMV, CPAP/PSV, DuoVent, PRVC, APRV,
PRVC-SIMV and VS ventilation mode.

Select to open the setting interface, and select [TRC] to finish the relevant settings. For details, refer
to “Section 10.13 Tube Resistance Compensation (TRC)”.

WARNING
 Wrong settings with the type, diameter or compensation of intubation may result in injury to
the patient. MAKE SURE the settings are correct.

CAUTION
 NEVER select non-invasive ventilation for an intubated patient.

7.4.2 Non-invasive Ventilation

Non-invasive ventilation refers to assist patient ventilation with a nasal mask or breathing mask, without
endotracheal intubation and tracheotomy.
Non-invasive ventilation modes include: For Adult/Pediatric: P-A/C, P-SIMV, CPAP/PSV, DuoVent, APRV
and PSV-S/T ventilation mode.

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The unavailable ventilation modes are gray.

CAUTION
 For patients without spontaneous breathing or with irregular spontaneous breathing, NEVER
use non-invasive ventilation mode. Non-invasive ventilation is only intended for patient with
spontaneous breathing.

 NEVER select non-invasive ventilation for an intubated patient.

7.4.3 Set Ventilation Type

Follow the steps below to set up ventilation type:

1) If the ventilator is not in standby mode, select the [Standby] button and then enter the standby interface
after confirmation.
2) Select [Last Patient], [New Adult] or [New Pediatric] in the current interface.
3) Set the ventilation type to [Non-invasive] or [Invasive] in the current interface.

7.5 Ventilation Mode

Note
 The ventilator does not produce negative pressure during expiratory phase.

 The maximum limited pressure is 95 cmH2O.

 The maximum working pressure is Paw upper alarm limit. The user can set the high-pressure
alarm limit for inspiratory phase. When the pressure reaches the alarm limit, the high-level
alarm " Paw too high " is triggered. The expiratory valve is opened to switch to the expiratory
phase, until Paw drops to preset PEEP value; if the Paw value exceeds high-pressure alarm
limit + 5cmH2O (adjustable pressure limit), the ventilator will open the safety valve to release
pressure until 0.5s after Paw drops to 3cmH2O. For the sake of patient safety, MAKE SURE to
set up a reasonable high-pressure alarm limit.

 P-A/C or P-SIMV ventilation mode is recommended if the patient is using a closed suction
catheter.

 The operator should set the ventilation parameters according to the actual situation of the
patient.

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7.5.1 Ventilation Mode and Parameter Settings

(1)

(2)

(1) Ventilation Mode area

Only selected ventilation modes are displayed in this area.
Unselected modes are not displayed in the Ventilation Mode area.
The ventilating modes available on this ventilator are: V-A/C, P-A/C, V-SIMV, P-SIMV, CPAP/PSV,
DuoVent, APRV, PRVC, PRVC-SIMV, VS and PSV-S/T. Your product may be equipped with different
combinations of ventilation modes.

To set up ventilation modes to be displayed:

1) Select the “…”key in the Ventilation Mode area.

2) Under the [Mode Configuration], select ventilation modes you want to be displayed in this area.
(2) Shortcut key area for parameter settings
Display the ventilation parameters corresponding to each ventilation mode. Select to display other
ventilation setting parameters. You can also set up parameters for the Sigh function and Tube Compensation
function here.
Different ventilation modes have different parameters.

The general method to set up ventilation parameters is as follows:

1) In the Ventilation Mode area, select the button corresponding to a desired ventilation mode to open the
menu, where you can set up the parameters for this ventilation mode.
2) Select the ventilation parameter button to be set.
3) If you are using the knob to select the parameter, press the main control knob, and turn the knob to set the
parameter to a suitable value, and press the knob again to confirm the setting.
4) After all parameters are set as required, select the [OK] button.

The shortcut method to set up ventilation parameters is as follows:

1) In the shortcut key area for parameter settings, select a desired ventilation parameter.
2) If you are using the knob to select the parameter, press the main control knob, and turn the knob to set the
parameter to a suitable value, and press the knob again to confirm the setting.
3) Set up other parameters in the same way.

7.5.2 Apnea Ventilation Mode

Apnea ventilation mode is an alternative mode enabled when patient apnea is detected in V-SIMV, P-SIMV,
CPAP/PSV, DuoVent, APRV, PRVC-SIMV and VS mode.

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The ventilator can exit apnea ventilation mode only when two consecutive spontaneous breaths are detected
from the patient, or when you switch to another ventilation mode, or turn off the apnea ventilation switch.
Two apnea ventilation modes are provided: Volume-controlled Apnea Ventilation and Pressure-controlled
Apnea Ventilation. Both modes are supported for invasive ventilation, and only Pressure-controlled Apnea
Ventilation is supported for non-invasive ventilation.
Volume-controlled apnea ventilation allows you to set up tidal volume, respiratory rate and inspiratory time of
the apnea ventilation cycle in the ventilation modes that support apnea ventilation. After entering apnea
ventilation, the ventilator performs PRVC mode ventilation with the preset tidal volume, respiratory rate and
inspiratory time of the apnea ventilation cycle (other parameter settings remain unchanged).
Pressure-controlled apnea ventilation allows you to set up inspiratory pressure, respiratory rate and inspiratory
time of the apnea ventilation cycle in the ventilation modes that support apnea ventilation. After entering
apnea ventilation, the ventilator performs P-A/C mode ventilation with the preset inspiratory pressure,
respiratory rate and inspiratory time of the apnea ventilation cycle (other parameter settings remain
unchanged).

CAUTION
 It is recommended to enable apnea ventilation mode under SIMV mode.

7.5.3 Leak Compensation

Leakage in the breathing tube, breathing mask, etc. may cause the amount of gas delivered to the patient's
lungs to fall below the preset value, false inspiratory triggering, or failure to switch between inhalation and
exhalation.
The ventilator has automatic leak compensation function, updating the leak volume according to the
difference between the inspiratory and expiratory tidal volume after the end of each breathing cycle. The leak
volume is used to calculate the real-time leak flow rate in the next breathing cycle. The real-time leakage flow
rate is proportional to the airway pressure: the higher the airway pressure, the larger the leakage flow rate.
In the expiratory phase, in order to avoid the decrease in PEEP due to leakage, the ventilator automatically
increases the basic flow rate to compensate for the leakage. To avoid false inspiratory triggering, the patient
flow rate used for triggering judgment is also leakage-compensated. The maximum leak compensation flow
rate is 65 l/min for adults and 45 l/ min for pediatric.
In volume-controlled mode, the volume of gas delivered by the ventilator is the preset tidal volume + leakage,
ensuring that the volume of gas delivered to the patient's lungs is equal to the preset value. The leakage
compensation in invasive ventilation, the maximum leakage compensation capacity is 80% of the preset tidal
volume.
In the volume-controlled mode, as the primary purpose is to maintain the preset inspiratory pressure, the
ventilator automatically increases the gas flow rate to compensate for leakage, until the maximum air supply
capacity is reached. The maximum leakage compensation capacity is also limited by the upper limit of the TV

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alarm. When the [Volume Limit] alarm is given, if you need to reach the maximum compensation capacity,
you can raise the upper limit of the TV alarm or turn off the alarm.
The flow rate waveform, volume waveform, TV monitoring parameters and MV monitoring parameters
displayed by the ventilator are all leakage-compensated.

7.5.4 V-A/C

In V-A/C mode, also called Volume-Controlled/Assist Ventilation mode, the ventilator delivers a certain tidal
volume to the patient's lungs within a certain time. V-A/C mode supports synchronous triggering in the
expiratory phase, that is, when the ventilator detects the patient's inhalation, it can start the next mechanical
ventilation in advance.
The typical waveforms of V-A/C mode control are as follows:

Pressure

Paw high alarm limit

Tpause(%) × Time of inspiration
Paw high
alarm limit -5

PEEP
Inspiration Expiration Time
Time Time Inspiration
Flow trigger level
1/Breathing
frequency

Inspiration
trigger level

Time

The basic ventilation parameters required under V-A/C mode are:

1. [O2%]: O2 concentration
2. [TV]: Tidal volume
3. [Tinsp] or [I:E]: Inspiratory time or ratio of inspiratory time to expiratory time
4. [f]: Breathing frequency
5. [PEEP]: Positive end-expiratory pressure
6. [Assist]: Switching trigger ON/OFF
7. [F-Trig] or [P-Trig]: Inspiratory triggering level
8. [Tpause(%)]: Percent of inspiratory pause time

The optional parameters of Sigh function under V-A/C mode are:

1. [Sigh]: Switch for turning on sigh function

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2. [Interval]: Time interval between two sighs

3. [Cycles Sigh]: Number of sigh cycles
4. [△int.PEEP]: PEEP added in sigh cycle
In the V-A/C mode, the parameters of the Auto Tube Resistance Compensation function can be set as required
(note that this function is applicable in all invasive modes):
1. [Tube Type]: Endotracheal tube, Tracheal tube or switch off TRC function
2. [Tube I.D.]: Diameter of tube
3. [Compensate]: Compensate portion
4. [Expiration]: Compensate of expiration

7.5.5 P-A/C

P-A/C mode is also called Pressure-Controlled/Assist Ventilation mode. This function enables the airway
pressure (Paw) to rise to the preset level in the set rise time in the inspiratory phase, and maintains that
pressure level until the end of inhalation, when exhalation phase starts.
In the pressure hold phase, the gas supply flow rate changes with the patient's lung resistance and compliance.
In the inspiratory phase, the system switches to expiratory phase immediately when the delivered volume
exceeds the preset upper limit of tidal volume alarm. In the expiratory phase, the ventilator supports
synchronous triggering, that is, once patient inhalation is detected, the next mechanical ventilation is started in
advance.
The typical waveforms of P-A/C mode control are as follows:

Pressure
Rise time

△ Pinsp

PEEP

Inspiration Inspiration Time

Time trigger level

Flow

Inspiration
trigger level

Time

TV Overrange

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The basic ventilation parameters required under P-A/C mode are:

1. [O2%]: O2 concentration
2. [△Pinsp]: Inspiratory pressure
3. [Tinsp] or [I:E]: Inspiratory time or ratio of inspiratory time to expiratory time
4. [f]: Breathing frequency
5. [PEEP]: Positive end-expiratory pressure
6. [Assist]: Switching trigger ON/OFF
7. [F-Trig] or [P-Trig]: Inspiratory triggering level
8. [Tslope]: Time of pressure rising
The optional parameters of Sigh function under P-A/C mode are:
1. [Sigh]: Switch for turning on sigh function
2. [Interval]: Time interval between two sighs
3. [Cycles Sigh]: Number of sigh cycles
4. [△int.PEEP]: PEEP added in sigh cycle

7.5.6 V-SIMV

V-SIMV mode, or volume-controlled synchronized intermittent mandatory ventilation, guarantees the lowest
preset ventilation frequency is realized. It provides a basic number of ventilations according to preset
frequency of intermittent mandatory ventilation. The mechanical ventilation mode provided is
Volume-Controlled/Assist Ventilation mode (V-A/C).
When SIMV is triggered in a trigger window, the ventilator delivers a volume-controlled ventilation. If SIMV
is still not triggered at the end of a trigger window, a volume-controlled ventilation is also delivered.
Spontaneous breathing or pressure support breathing is conducted out of the trigger window.
The typical waveforms of V-SIMV+PSV mode control are as follows:

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V-SIMV+PSV
SIMV cycle SIMV cycle

Pressure

Trigger Volume Trigger Volume Trigger

window control window control window

Pressure support

Inspiratory trigger

Time

Flow

Time

The basic ventilation parameters required under V-SIMV mode are:

1. [O2%]: O2 concentration
2. [TV]: Tidal volume
3. [Tinsp]: Inspiratory time
4. [fsimv] Mandatory breathing frequency
5. [Tpause(%)]: Percent of inspiratory pause time
6. [△Psupp]: Pressure support level
7. [PEEP]: Positive end-expiratory pressure
8. [F-Trig] or [P-Trig]: Inspiratory trigger level
9. [Exp%]: Expiratory trigger level
10. [Tslope]: Time of pressure rising
11. [Apnea Vent.]: Switch for apnea ventilation
12. [TVapnea] or [△Papnea]: Tidal volume or inspiratory pressure in apnea ventilation cycle
13. [fapnea]: Frequency of apnea ventilation
14. [Apnea Tinsp]: Inspiratory time in apnea ventilation

The optional parameters of Sigh function under V-SIMV mode are:

1. [Sigh]: Switch for turning on sigh function
2. [Interval]: Time interval between two sighs
3. [Cycles Sigh]: Number of sigh cycles
4. [△int.PEEP]: PEEP added in sigh cycle

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7.5.7 P-SIMV

P-SIMV mode, or pressure-controlled synchronized intermittent mandatory ventilation, guarantees the lowest
preset ventilation frequency is realized. It provides a basic number of ventilations according to preset
frequency of intermittent mandatory ventilation. The mechanical ventilation mode provided is
Pressure-Controlled/Assist Ventilation mode (P-A/C).
When SIMV is triggered in a trigger window, the ventilator delivers a pressure-controlled ventilation. If
SIMV is still not triggered at the end of a trigger window, a pressure-controlled ventilation is also delivered.
Spontaneous breathing or pressure support breathing is conducted out of the trigger window.
The typical waveforms of P-SIMV+PSV mode control are as follows:

P-SIMV+PSV
SIMV cycle SIMV cycle
Pressure

Trigger Pressure Trigger Pressure Trigger

window control window control window

△ Psupp

Inspiratory trigger

Time

Flow

Time

The basic ventilation parameters required under P-SIMV mode are:

1. [O2%]: O2 concentration
2. [△Pinsp]: Inspiratory pressure
3. [Tinsp]: Inspiratory time
4. [fsimv] Respiratory rate
5. [Tslope]: Time of pressure rising
6. [PEEP]: Positive end-expiratory pressure
7. [Exp%]: Expiratory trigger level
8. [△Psupp]: Pressure support level
9. [F-Trig] or [P-Trig]: Inspiratory trigger level
10. [Apnea Vent.]: Switch for apnea ventilation
11. [TVapnea] or [△Papnea]: Tidal volume or inspiratory pressure in apnea ventilation cycle
12. [fapnea]: Frequency of apnea ventilation

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13. [Apnea Tinsp]: Inspiratory time in apnea ventilation

The optional parameters of Sigh function under P-SIMV mode are:

1. [Sigh]: Switch for turning on sigh function
2. [Interval]: Time interval between two sighs
3. [Cycles Sigh]: Number of sigh cycles
4. [△int.PEEP]: PEEP added in sigh cycle

7.5.8 CPAP/PSV

PSV mode is called the pressure support ventilation mode, which delivers a pressure support ventilation when
the system detects the patient's inhalation effort reaches the preset inspiratory trigger level. In this mode, the
pressure rise time and pressure support level are set by the user.
At the beginning of inspiratory phase, the ventilator increases the airway pressure to the preset level within the
preset time of pressure rising (Tslope), and maintain this pressure level until the patient's inspiratory flow rate
is detected to reach the expiratory trigger level.
The gas supply flow rate in the PSV pressure hold phase changes with the patient's lung resistance and
compliance.

Pressure Apnea
Pressure Support
Ventilation Ventilation

Pressure support ΔPapnea

Inspiratory trigger Time

Rise time
Flow

Expiratory trigger
Inspiratory trigger

Time

Apnea time
Apnea Tinsp
Apnea
Ventilation Cycle

CPAP mode, which is also called continuous positive airway pressure ventilation mode, maintains the airway
pressure at a preset positive pressure level throughout the ventilation cycle, but the patient should have
Pressure
spontaneous breathing so as to control the respiratory rate, timing and volume. When the system detects that
Spontaneous breathing Apnea Ventilation

the patient has no spontaneous breathing for a time period longer than the preset apnea limit, the backup apnea
△ Papnea
ventilation mode will be activated to continue ventilation.
PEEP

Time
Rise time
Flow

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Time
 Start Ventilation

The basic ventilation parameters required for invasive ventilation under CPAP/PSV mode are:
1. [O2%]: O2 concentration
2. [△Psupp]: Pressure support level
3. [PEEP]: Positive end-expiratory pressure
4. [F-Trig] or [P-Trig] Inspiratory trigger level
5. [Exp%]: Expiratory trigger level
6. [Tslope]: Time of pressure rising
7. [Exp%]: Tidal volume or inspiratory pressure in apnea ventilation cycle
8. [fapnea]: Frequency of apnea ventilation
9. [Apnea Tinsp]: Inspiratory time in apnea ventilation

The basic ventilation parameters required for non-invasive ventilation (NIV) under CPAP/PSV mode are:
1. [O2%]: O2 concentration
2. [△Psupp]: Pressure support level
3. [PEEP]: Positive end-expiratory pressure
4. [Timax]: Maximum time of inspiration
5. [F-Trig] or [P-Trig] Inspiratory trigger level
6. [Exp%] Expiratory trigger level
7. [Tslope] Time of pressure rising
8. [TVapnea] or [△Papnea] Tidal volume or inspiratory pressure in apnea ventilation cycle
9. [fapnea] Frequency of apnea ventilation
10. [Apnea Tinsp] Inspiratory time in apnea ventilation

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7.5.9 PRVC

PRVC mode, or Pressure-regulated Volume Control mode, attempts to achieve set tidal volume at lowest
possible airway pressure. The pressure control level varies with the tidal volume setting and the resistance and
compliance of the patient’s lungs.
In the first three cycles of ventilation, the pressure increase does not exceed 10cm H2O, and thereafter, the
pressure increase does not exceed 3cmH2O each cycle. The maximum pressure does not exceed the upper
pressure alarm limit -5cmH2O.
The first PRVC ventilation cycle is experimental, delivering the gas at a pressure of 10cm H2O + PEEP
intended to calculate the compliance and resistance of the system and the patient’s lungs. The obtained results
are used to calculate the pressure level suitable for the patient. In subsequent ventilation cycles, the system
will use this pressure level as the adjustment target for tidal volume control.
The typical waveforms of PRVC mode control are as follows:

The basic ventilation parameters required under PRVC mode are:

1. [O2%]: O2 concentration
2. [TV]: Tidal volume
3. [Tinsp] or [I:E]: Inspiratory time or ratio of inspiratory time to expiratory time
4. [f]: Respiratory rate
5. [PEEP]: Positive end-expiratory pressure
6. [Assist]: Switching trigger ON/OFF
7. [F-Trig] or [P-Trig] Inspiratory trigger level
8. [Tslope] Time of pressure rising
The optional parameters of Sigh function under PRVC mode are:
1. [Sigh]: Switch for turning on sigh function
2. [Interval]: Time interval between two sighs

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3. [Cycles Sigh]: Number of sigh cycles

4. [△int.PEEP]: PEEP added in sigh cycle

7.5.10 PRVC-SIMV

The PRVC-SIMV (Pressure Regulated Volume Control-Synchronized Intermittent Mandatory Ventilation)

mode guarantees basic ventilation rate according to the preset intermittent mandatory ventilation frequency in
volume-controlled mode (PRVC mode).
When SIMV is triggered in a trigger window, the ventilator delivers a volume-controlled ventilation. If SIMV
is still not triggered at the end of a trigger window, a volume-controlled ventilation is also delivered.
Spontaneous breathing or pressure support breathing is conducted out of the trigger window.
The typical waveforms of PRVC-SIMV+PSV mode control are as follows:

PRVC-SIMV+PSV
SIMV cycle SIMV cycle

Pressure Trigger Trigger Trigger

window Volume window Volume window
control control

Pressure support

Inspiratory trigger

Time

Flow

Time

The basic ventilation parameters required under PRVC-SIMV mode are:

1. [O2%]: O2 concentration
2. [TV]: Tidal volume
3. [Tinsp] or [I:E]: Inspiratory time
4. [fsimv]: Respiratory rate
5. [△Psupp]: Pressure support level
6. [PEEP]: Positive end-expiratory pressure
7. [F-Trig] or [P-Trig] Inspiratory trigger level
8. [Exp%] Expiratory trigger level
9. [Tslope] Time of pressure rising
10. [Apnea Vent.] Switch for apnea ventilation
11. [TVapnea] or [△Papnea] Tidal volume or inspiratory pressure in apnea ventilation cycle

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12. [fapnea] Frequency of apnea ventilation

13. [Apnea Tinsp] Inspiratory time in apnea ventilation

The optional parameters of Sigh function under PRVC-SIMV mode are:

1. [Sigh]: Switch for turning on sigh function
2. [Interval]: Time interval between two sighs
3. [Cycles Sigh]: Number of sigh cycles
4. [△int.PEEP]: PEEP added in sigh cycle.

7.5.11 DuoVent

In DuoVent (dual level positive airway pressure ventilation) mode, the ventilator provides two different levels
of positive airway pressure alternately for mechanical ventilation or spontaneous breathing. The patient can
spontaneously breathe at both pressure levels, where pressure support can be set during the low-pressure
phase. There are trigger windows in both high- and low-pressure stages: the trigger window in the
low-pressure stage is 5 seconds after the low-pressure time, and the trigger window in the high-pressure stage
is the last quarter at the end of the high-pressure time.
In the trigger window of the low-pressure phase, the inspiratory trigger will start high-pressure gas supply;
and in the trigger window of the high-pressure phase, the expiratory trigger will start low-pressure gas supply.
The typical pressure waveforms of DuoVent mode are as follows:

Pressure ¼ Thigh
Thigh Tlow
Trigger
window
5s 5s

Trigger Trigger
window window
PSV

Phigh

Rise Time Plow

Time

Inspiratory trigger
Expiratory trigger

The basic ventilation parameters required under DuoVent mode are:

1. [O2%]: O2 concentration
2. [Phigh]: High pressure
3. [Thigh] or [f]: Time of high pressure or breathing frequency
4. [Plow]: Low pressure
5. [Thigh] or [Tinsp]: Low pressure time or inspiratory time
or [I:E] or ratio of inspiratory time to expiratory time
6. [△Psupp]: Pressure support level
7. [F-Trig] or [P-Trig]: Inspiratory trigger level

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8. [Exp%]: Expiratory trigger level

9. [Tslope]: Time of pressure rising
10. [TVapnea] or [△Papnea]: Tidal volume or inspiratory pressure in apnea ventilation cycle
11. [fapnea]: Frequency of apnea ventilation
12. [Apnea Tinsp]: Inspiratory time in apnea ventilation

7.5.12 APRV

The APRV (Airway Pressure Release Ventilation) mode can be regarded as CPAP mode integrated with
periodic, short-term airway pressure release.
The typical pressure waveforms of APRV mode are as follows:

Pressure

Thigh Tlow

Phigh

Rise time
Plow

Time

The basic ventilation parameters required under APRV mode are:

1. [O2%]: O2 concentration
2. [Phigh]: High pressure
3. [Thigh] : Time of high pressure
4. [Plow]: Low pressure
5. [Tlow]: Time of low pressure
6. [Tslope]: Time of pressure rising
7. [TVapnea] or [△Papnea]: Tidal volume or inspiratory pressure in apnea ventilation cycle
8. [fapnea]: Frequency of apnea ventilation
9. [Apnea Tinsp]: Inspiratory time in apnea ventilation
10. [F-Trig] or [P-Trig]: Inspiratory trigger level

7.5.13 VS

In VS (Volume Support) ventilation mode, the ventilator starts a volume support ventilation when the system
detects the patient's inhalation effort has reached the preset inspiratory trigger level. This mode adjusts the

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pressure support level according to the resistance and compliance of the patient's lungs and breathing efforts,
in order to ensure the patient is provided with preset tidal volume.
In this mode, the time period of the inspiratory phase and expiratory phase is controlled by the patient. When
the system detects that the patient has no effective inspiratory triggering action in a time period longer than a
preset apnea time, the system will enable the apnea ventilation mode to continue ventilation.
The first VS ventilation cycle is experimental in volume-controlled mode (V-A/C mode), intended to calculate
the compliance and resistance of the system and the patient ’s lungs. The obtained results are used to calculate
the pressure support level suitable for the patient. In subsequent ventilation cycles, the ventilator will use this
pressure level as the adjustment target for tidal volume control.
In the first three cycles of ventilation, the pressure increase does not exceed 10cm H2O, and thereafter, the
pressure incensement does not exceed 3cmH2O each cycle. The maximum pressure does not exceed the upper
pressure alarm limit -5cm H2O.
The typical waveforms of VS mode control are as follows:

Airway pressure ≤ Airway pressure high limit-5cmH2O

Pressure
Apnea Ventilation
Volume Support Ventilation

Pressure Pressure of Apnea

support Ventilation

Inspiratory trigger Time

Rise time
Flow

Expiratory
trigger

Time

I:E=1:2
Apnea time
Apnea Ventilation Cycle

The basic ventilation parameters required under VS mode are:

1. [O2%]: O2 concentration
2. [TV]: Tidal volume
3. [PEEP]: Positive end-expiratory pressure
4. [F-Trig] or [P-Trig]: Inspiratory trigger level
5. [Exp%]: Expiratory trigger level
6. [Tslope]: Time of pressure rising
7. [TVapnea] or [△Papnea]: Tidal volume or inspiratory pressure in apnea ventilation cycle
8. [fapnea]: Frequency of apnea ventilation
9. [Apnea Tinsp]: Inspiratory time in apnea ventilation

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7.5.14 PSV-S/T

In PSV-S/T (Pressure Support Ventilation-Spontaneous/Timed) mode, the ventilator starts a pressure support
ventilation when the system detects the patient's inhalation effort has reached the preset inspiratory trigger
level. This mode adjusts the pressure support level according to the resistance and compliance of the patient's
lungs and breathing efforts, in order to ensure the patient is provided with preset tidal volume. Both the
pressure rise time and the pressure support level are set by the user. At the beginning of inspiratory phase, the
ventilator increases the airway pressure to the preset level within the preset time of pressure rising (Tslope),
and maintain this pressure level until the patient's inspiratory flow rate is detected to reach the expiratory
trigger level.
In PSV-S/T ventilation mode, when the system detects no patient trigger within the preset maximum breathing
cycle (60s/RR), a mandatory ventilation is started automatically. The mandatory ventilation cycle is
determined by the preset [f] And [Tinsp]. When the system detects patient trigger within the preset maximum
breathing cycle (60s/RR), the system starts a pressure ventilation.

Pressure
Pressure Support Ventilation Backup Ventilation Pressure Support Ventilation

Pressure support Pressure support

Inspiratory trigger Inspiratory trigger

Flow Rise time Time

Expiratory trigger Inspiratory

Inspiratory trigger trigger

Time

Minimum respiratory
Inspiration Time
cycle length

The basic ventilation parameters required under PSV-S/T mode are:

1. [O2%]: O2 concentration
2. [△Psupp]: Pressure support level
3. [PEEP]: Positive end-expiratory pressure
4. [F-Trig] or [P-Trig]: Inspiratory trigger level
5. [Exp%]: Expiratory trigger level
6. [Tslope]: Time of pressure rising
7. [f]: Respiratory rate in mandatory ventilation
8. [Tinsp]: Inspiratory time in mandatory ventilation
9. [Timax]: Maximum time of inspiration (only for pressure support
ventilation cycle)

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7.6 Alarm Limit Settings

Select the [Alarm] hotkey to open the alarm menu, select [Limit 1], and set the alarm limits for Paw, MV,
TVe, ftotal, and Tapnea as required.
If the O2 source type is set to [low-pressure O2], you can set the alarm limits of FiO2 in [Limit 2] .
If your ventilator is equipped with CO2 module, you can also set the alarm limits of EtCO2 in [Limit 2].
If your ventilator is equipped with SpO2 module, you can also set the alarm limits of SpO2 and RR in [SpO2].
You can also set volume for alarms in [Audio].

7.7 Start Ventilation

To start ventilation, select the [Start Ventilation] button on the interface in standby mode. The system will
provide ventilation to the patient according to your settings.

WARNING
 Before using, check whether the oxygen concentration of the delivered gas is consistent with the
set value.

 If any problem occurs with the ventilator, do switch to manual ventilation immediately,
otherwise it may cause death of the patient.

7.8 Ventilation Parameters

WARNING
 The ventilator is to be provided with O2 monitoring equipment that conforms with ISO
80601-2-55:2018 before being put into service. If the equipment you are using is not equipped
with O2 concentration monitoring function, use with a respiratory gas monitor that meets the
requirements of ISO80601-2-55 for oxygen concentration monitoring.

 The ventilator is to be provided with CO2 monitoring equipment for the measurement of
expiratory carbon dioxide concentration, (e.g. in the expiratory limb or at the patient
connection port) in accordance with ISO 80601-2-55 before being put into service.

Note
 All parameters are calculated using real-time flow and pressure waveform. Low-pass filtering
is used to measure the real-time flow rate and pressure, with the original sampling rate
standing at 1kHz, and the cutoff frequency at 20Hz.

 Tidal volume, minute volume displayed on the ventilator associated the VBS and related

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 Start Ventilation

calculation parameters are in the BTPS condition.

Parameter Description
TV The volume inspired and expired with each breath of the patient at rest.
O2% The volume percentage of oxygen in the gas delivered to the patient.
I:E The ratio between the inspiratory and expiratory time.
PEEP Positive end-expiratory pressure.
Phigh Phigh is the high pressure level at which the patient can spontaneously breathe and is
an absolute value.
△Pinsp It is a relative value of the pressure, relative to PEEP.
Plow Plow is the low pressure level at which the patient can breathe spontaneously.
△Psupp The inspiratory pressure level after the patient triggers the support pressure, which is
a value relative to PEEP or Plow.
Tslope Controls pressure rise slope in pressure mode.
Tpause (%) The pause time as a percentage of the inspiratory time.
f The number of mechanically controlled breaths delivered to the patient in one minute.
fsimv Mandatory breathing frequency set in SIMV mode.
Thigh Thigh is the time that the ventilator will hold the high pressure level.
Tlow Tlow is the time that the ventilator will hold the low pressure level.
Tinsp The inspiratory time in a breathing cycle.
Timax The maximum length of inspiratory time in a breathing cycle.
F-Trig / P-Trig The inspiratory phase starts when the ventilator detects the trigger level of pressure
trigger/flow trigger.
Exp% At the end of inspiratory phase, when inspiratory flow drops to (peak flow * Exp%),
the expiratory phase starts.
Assist Used to turn on / off the assist trigger function. When this function is turned on, the
ventilator allows the patient to trigger mechanical ventilation at the end of expiratory
phase.
Apnea Vent Turn on or turn off apnea ventilation function.
△Papnea It is inspiration pressure in apnea ventilation when pressure mode is selected
for apnea ventilation. It is a relative value relative to PEEP or Plow.
fapnea Breathing frequency set in apnea ventilation mode.
TVapnea The tidal volume delivered in apnea ventilation when the apnea ventilation is set to
volume- controlled mode.
Apnea Tinsp Inspiratory time set in apnea ventilation mode.
Sigh Turn on or turn off sigh function.
Interval It is the setting value of time interval between two groups of sigh ventilation.
Cycles Sigh It is the setting value of number of cycles of every group of sigh ventilation.
△int.PEEP It is intermittent PEEP augmentation, added during the sigh cycle.
Disable TRC Turn on or turn off TRC function.
ET Tube Initiate TRC function for ET tube.
Trach Tube Initiate TRC function for Trach tube.
Tube I.D. It refers to the diameter of tracheal or ET tube.
Compensate Percentage of compensation for automatic intubation resistance.
Expiration Turn on or turn off TRC function during the expiratory phase.

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 Start Ventilation

7.9 Enter Standby

Select the [Standby] button and confirm to enter the standby interface. Now ventilation will be stopped.

WARNING
 Before entering standby state, MAKE SURE an alternative ventilation is available to prevent
harm to patients due to lack of ventilation support. In addition, MAKE SURE that no patient is
connected to the ventilator.

 In order to prevent the gas from overheating which may harm the patient or damage the
breathing tube, the humidifier should be turned off when entering standby.

7.10 Shut Down

In standby mode, press button until the ventilator is turned off.

In a non-standby state, if you select the button, the system prompts [Please enter Standby mode to shut
down the system.]. Select [OK] to return to the previous non-standby state. Select the [Standby] button and
then confirm to enter the standby interface. Now you can select the switch to turn off the ventilator.

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 Chapter 8 CO2 Monitoring

8.1 Overview

The ventilator uses the CO2 measurement to monitor the patient’s breath state and control his/her ventilation.
There are two methods of measuring the CO2 in the patient’s airway:
 Sidestream measurement method: take samples from the respiratory gas sensor in the patient’s airway at
a constant flow rate and use the built-in remote CO2 sensor in the measurement system to analyze them.
 Mainstream measurement method: install the CO2 sensor onto the airway connector of the respiratory
system inserted directly into the patient.
In the above two cases, the measurement principle is IR emission. Use the optical detector to measure the
intensity of the infrared rays penetrating the respiratory system. Such intensity depends on the CO2
concentration as some infrared rays will be absorbed by CO2 molecules.
CO2 measurement is intended for adult and pediatric/Infant patients.
The CO2 measurement involves the following parameters.
 CO2 waveform
 End-tidal CO2 (EtCO2): the maximum partial pressure of CO2 at the end of a breath.

8.1.1 CO2 derived functions

For mainstream CO2 modules, in addition to providing CO2 waveform and EtCO2 monitoring parameters, it
also provides:
1. V-CO2 loop
2. Monitoring parameters:
 Vtalv: Alveolar tidal volume
 V’alv: Alveolar minute ventilation
 VDaw: Airway dead space
 VDaw/TVe: Ratio of airway dead space to tidal volume
 slopeCO2: CO2 rising slope.
 V’CO2: CO2 elimination.
 ViCO2: inspired CO2 volume.
 VeCO2: exhaled CO2 volume.

WARNING
 Please make sure that the patient's heart and lungs are in a stable state to obtain the most
accurate CO2 measurement results.

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 CO2 Monitoring

 System leakage, respiratory rate higher than 35/min, and non-invasive ventilation types may
affect the accuracy of mainstream CO2 monitoring parameters. The affected monitoring
parameters include: (Vdaw, Vdaw/Tve, Vtalv, V’alv, slopeCO2, V’CO2, VeCO2, ViCO2

 The exhaled volume and exhaled CO2 of the patient can differ from the measured exhaled
volume and exhaled CO2 due to leaks around the mask.

8.2 Safety Information

WARNING
 Place sampling line and other pipes well to prevent the patient from being entangled and thus
suffering from apnea.

 Never use this device in an environment with inflammable anesthetic gases.

 Only the trained professionals familiar with this Manual are allowed to operate the device.

 Masimo CO2 have the automatic atmospheric pressure compensation function.

 Respironics and Comen CO2 sensors have no function of atmospheric pressure compensation,
and have been set with a fixed value before delivery. If the value needs updated due to the
altitude, contact the maintenance personnel.

 All parts or accessories except Respironics pathway adaptor did not contain phthalates or
other substances, which are classified as endocrine disrupting, carcinogenic, mutagenic.

 Respironics pathway adaptor contains phthalates, such indication was marked on package.

 Take more care to treatment of children and treatment of pregnant and nursing women, who
may allergy to such substance.

CAUTION
 When the patient is being treated with nebulized drugs, CO2 concentration can not be
measured. After the Nebulizer function is activated, sampling and monitoring of CO2 modules
will be suspended.

 The EtCO2 measured by CO2 module may differ slightly from the partial pressure of carbon
dioxide (PCO2) measured by arterial blood gas analyzer.

 When the [CO2 monitoring] is set at on, and if Nebulization is activated, [CO2 monitoring Off]
would be displayed as information signal, and set the [Monitoring] under [Sensor] to [OFF].
After 1 min upon completion of nebulization, the CO2 monitoring is restarted, [CO2 start]
would be displayed as information signal.

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 CO2 Monitoring

Note
 The sampling gas of sidestream CO2 module is the mix of air and oxygen only. The exhaust gas
could be emitted to the environment for disposal.

8.3 Adverse Effects on Performance

1) The following factors are known adverse effects on the specified performance:
 Quantitative effects of RH or condensation;
 Quantitative effects of barometric pressure;
 Interfering gas or water vapor; and
 Other interference sources.
2) Gas Measurement Unit
Use volume percentage as the gas concentration unit. The concentration calculation formula is:

Use the cup-making pressure sensor of the ISA gas analyzer to measure the total pressure of the gas mixture.
To convert into any other unit, use the actual barometric pressure sent from the ISA sidestream (IRMA
mainstream).
CO2 (mmHg) = (CO2 Concentration) x (Barometric Pressure from ISA (kPa)) x (750 / 100).
Take 5.0 vol% CO2 @ 101.3kPa as an example: 0.05 x 101.3 x 750 / 100 = 38 (mmHg).
3) Effects of RH
The partial pressure and volume percentage of the CO2, N2O, O2 and anesthetic gas depend on the water vapor
content in the measured gas. Calibrate the O2 measurement, and the displayed value at the ambient
temperature and RH level will be 20.8 vol%, not the actual partial pressure. The 20.8 vol% O2 represents the
actual O2 concentration of the room air (water concentration: 0.7 vol %) (for example, 25°C and 23% RH @
1013hPa). The ventilator displays the actual partial pressure at the current RH level when measuring the CO2,
N2O and anesthetic gas (like all gases measured by infrared cell).
In the patient’s alveoli, the water vapor in the respiratory gas is saturated (BTPS) at the body temperature.
Before the acquired respiratory gas in the sampling tube is transferred to the ISA sidestream gas analyzer, its
temperature becomes approximate to the ambient temperature. No water enters the ISA gas analyzer after the
Nomoline sampling tube removes all condensed water. The RH of the acquired gas is approximately 95%.
Use the following formula to calculate the CO2 value at BTPS:

In the above formula:

EtCO2: EtCO2 value [vol%] sent from ISA
Pamb : barometric pressure [kPa] sent from ISA
3.8 : typical partial pressure [kPa] of the water vapor condensed between the patient circuit and ISA
EtCO2 (BTPS) = EtCO2 concentration [vol%] at BTPS
It is assumed that the O2 is calibrated by the room air at 0.7 vol% H2O (RH).

8-3
 CO2 Monitoring

8.4 CO2 Measure

WARNING
 Check the airway adapter before use. Replace it if the airway adapter suffers from any exterior
damage or breakage.

 Turn it off when the CO2 module is idle, or it will remain in working state and its service life
will be shortened.

 Hang the external CO2 analyzer onto the CO2 sensor holder on the back housing of the device
reliably against falling and damage.

 MAKE SURE all connections are firm and reliable. Any leakage will cause the respiratory gas
of the patient to include the ambient air, resulting in incorrect readings.

 Check CO2 sensor regularly for avoiding excessive humidity or secretion accumulation.

CAUTION
 The Water Filter Assembly of Respironics sidestream CO2 sensor will last up to 12 hours when
used without the Dehumidification Tubing in a non-humidified environment.

 The Water Filter Assembly of Respironics sidestream CO2 sensor will last up to 120 hours
when used with the Dehumidification Tubing under conditions of ISO 80601-2-55 §
201.7.9.2.9.101b.

 The life of the water filter assembly of Respironics sidestream CO2 sensor will be significantly
reduced if used in a humidified circuit without dehumidification tubing.

The Dehumidification Tubing is a replaceable part and is attached directly to the Water Filter Assembly. The
Dehumidification tubing should be regularly examined for cracks or visual contaminates on its walls. If these
conditions exist, the Dehumidification Tubing should be discarded in accordance with clinical protocol and
replaced with a new part.

8.4.1 Preparations for Mainstream CO2 Sensor Connection

1) Connect the adapter cable with the CO2 sensor cable (no need for Comen mainstream CO2).
2) Insert the other end of the adapter cable into the CO2 sensor interface on the device.
3) Wait for 10s (Masimo sensor) or 1min (Respironics and Comen sensor) until the sensor reaches its
working temperature and a stable thermal state.
4) Fix the sensor to the airway adapter.

8-4
 CO2 Monitoring

(1)

(2)

(1) Sensor (2) Airway adapter

5) Turn on CO2 [Monitoring]. Refer to "Section 8.6.1 CO2 Monitoring Setting".
6) For zero calibration of the sensor, refer to "Section 8.5.1 Zero Mainstream CO2 Sensors".
7) Install the airway adapter onto one end of the breathing tube, between the Y-shaped tube (see figure
below).

(2)

(1)

(4) (3)

(1) Elbow tube (2) Y-shaped tube (3) Airway adapter (4) Breathing tube port

8) Make sure the airway is tight.

9) Set CO2 parameters; please refer to “Section 8.6 CO2 Setting” for more information.
10) Start measurement.

8.4.2 Preparations for Sidestream CO2 Sensor Connection

8.4.2.1 Preparations for Respironics Sidestream CO2 Sensor

1) Plug the CO2 sensor cable into the CO2 sensor interface on the device.
2) Wait for 2min until the sensor reaches its working temperature and a stable thermal state.
3) Connect one end of the drying tube to the water filter component, and the other end with the sampling
line, thus forming the sampling line component.
4) Insert the sampling line component into the CO2 analyzer interface. A sound of “click” represents it is
inserted correctly and locked in place.
5) Switch on CO2 [Monitoring]. Refer to "Section 8.6.1 CO2 Monitoring Setting".

8-5
 CO2 Monitoring

6) Zero the sensor; please refer to "Section 8.5.2 Zero Sidestream CO2 Sensor" for more information.
7) Set CO2 parameters; please refer to "Section 8.6 CO2 Setting" for more information.
8) For the patient with tracheal cannula: install the airway adapter of sampling line onto one end of the
breathing tube, exactly speaking, between the elbow tube and the Y-shaped tube, shown as the figure
below:

(1)
(2)

(3)
(5)

(4)

(1) Sampling line (2) Y-shaped tube (3) Airway adapter (4) Breathing tube port (5) Elbow tube

9) Wear the nasal cannula for the patient without tracheal cannula: wear the nasal or oral-nasal O2 cannula
onto the patient's face, connect the O2 supply tube to the O2 supply system and set the O2 flow as
directed.
10) Start the measurement after confirming the airway tightness.

8.4.2.2 Preparations for Masimo Sidestream CO2 Sensor

1) Insert sampling line into the interface of CO2 sensor reliably until you hear a "click" sound.
2) Wait for 10s until the sensor reaches its working temperature and a stable thermal state.
3) Switch on CO2 [Monitoring]. Refer to "Section 8.6.1 CO2 Monitoring Setting".
4) Zero the sensor; please refer to "Section 8.5.2 Zero Sidestream CO2 Sensor" for more information.
5) Check before its use; please refer to "Section 8.4.2.2.1 Pre-use Checks" for more information.
6) Set CO2 parameters; please refer to "Section 8.6 CO2 Setting" for more information.
7) For the patient with tracheal cannula: install the airway adapter onto one end of the breathing tube,
exactly speaking, between the elbow tube and the Y-shaped tube, shown as the figure below:

(1)
(2)

(3)
(5)

(4)

(1) Sampling line (2) Y-shaped tube (3) Airway adapter (4) Breathing tube port (5) Elbow tube

8) Wear the nasal cannula for the patient without tracheal cannula: wear the nasal or oral-nasal O2 cannula
onto the patient's face, connect the O2 supply tube to the O2 supply system and set the O2 flow as
directed.

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 CO2 Monitoring

8.4.2.2.1 Pre-use Checks

Perform the following operations before connecting the sampling line to the breathing tube:
1) Connect the sampling line to the CO2 interface.
2) Check if the sensor interface LED remains green stably (an indication of normal system).
3) Expire into the sampling line and check if the ventilator displays the effective CO2 waveform and value.
4) Block the sampling line with a fingertip and wait 10s.
5) Check if the prompt message “Sampling line clogged” appears and the sensor interface LED flashes in
red.
6) Check the tightness of the patient circuit connected to the sampling line when appropriate.

WARNING
 Place the IRMA sensor, if not protected by HME, with the status LED pointing up.

 Do not stretch the cable of the ISA sidestream gas analyzer.

 Operate the ISA sidestream gas analyzer in the specified working temperature environment
only.

Note
 In order to prevent the condensed water dropping into the gas sampling line and blocking it,
the gas sampling line connection end of the airway adapter should point up.

8.4.2.3 Preparations for Comen Sidestream CO2 Sensor

1) Insert CO2 cable to the ventilator's CO2 interface.

2) Wait for 2min until the sensor reaches its working temperature and a stable thermal state.
3) Insert sampling line into the interface of CO2 sensor reliably until you hear a click sound.
4) Switch on CO2 [Monitoring]. Refer to "Section 8.6.1 CO2 Monitoring Setting".
5) Zero the sensor; please refer to "Section 8.5.2 Zero Sidestream CO2 Sensor" for more information.
6) Set CO2 parameters; please refer to "Section 8.6 CO2 Setting" for more information.
7) For the patient with tracheal cannula: install the airway adapter of sampling line onto one end of the
breathing tube, exactly speaking, between the elbow tube and the Y-shaped tube, shown as the figure
below:

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 CO2 Monitoring

(1)
(2)

(3)
(5)
(4)

(1) Sampling line (2) Y-shaped tube (3) Airway adapter (4) Breathing tube port (5) Elbow tube

8) Wear the nasal cannula for the patient without tracheal cannula: wear the nasal or oral-nasal O2 cannula
onto the patient's face, connect the O2 supply tube to the O2 supply system and set the O2 flow as
directed.
9) Start the measurement after confirming the airway tightness.

8.5 Zero CO2 Sensor

WARNING
 If the alarm message "CO2 Need Zero" appears directly after zeroing, please re-zero it.

Note
 For the best zeroing result, please zero Respironics CO2 sensor after preheating for 5min.

In order to eliminate the effect of baseline drift on measurement results and obtain accurate measurement
results, please zero it before using CO2 sensor to monitor the patient.

8.5.1 Zero Mainstream CO2 Sensors

You can zero it manually when you consider it necessary by the following steps:
1) Connect the sensor to CO2 module.
2) Select [Setup] → [Sensor] ,and set [Monitoring] to on .
3) After preheating, connect the sensor to airway adapter.
4) Expose the sensor to room air and keep it away from all CO2 sources, including ventilator, patient's
breath and user's breath.
5) Select [Setup] → [Sensor] → [CO2] → [Zero]; then [CO2 Zero] will be prompted on the screen.
6) When zeroing is successful, [Zeroing Complete] is displayed as information signal.

8.5.2 Zero Respironics and Comen Sidestream CO2 Sensors

You can zero it manually when you consider it necessary by the following steps:
1) Connect the sampling line to CO2 sensor.

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 CO2 Monitoring

2) Select [Setup] key → [Sensor] ,and set [Monitoring] to on.

3) After preheating, expose the sampling line to room air and keep it away from all CO2 sources, including
ventilator, patient's breath and user's breath.
4) Select [Setup] → [Sensor] → [CO2] → [Zero]; then [CO2 Zero] will be prompted on the screen.

8.5.3 Zero Masimo Sidestream CO2 Sensors

For Masimo sidestream CO2 module, when you detach the sampling tube from the device, the module would
start the zeroing procedure. When the zeroing is successfully, [Zeroing Complete] is displayed as information
signal.

8.6 CO2 Setting

8.6.1 CO2 Monitoring Setting

1) Select [Setup] key → [Sensor] → [CO2] tab.

2) Set [Monitoring].
 When [Monitoring] is switched to [On], CO2 sensor will enter the running mode; CO2 parameters and
waveform will be displayed and physiological and technical alarms related to CO2 module will be
provided by the device.
 When [Monitoring] is switched to [Off], CO2 sensor will enter the sleeping mode; CO2 parameters and
waveform will not be displayed; physiological or technical alarms related to CO2 module will not be
provided by the device.
The sleeping mode of the CO2 module is related to the standby mode of the device.
 If the device enters the standby mode, then the CO2 module is switched to the sleeping mode.
 If the device exits the standby mode, then the CO2 module returns to its previous mode before sleeping.
 Then ventilator is not be influenced by the running/sleeping mode switching of the CO2 module.
In sleeping mode, the infrared source of CO2 module is turned off by the system to reduce the power
consumption and extend the module’s service life.

8.6.2 Set CO2 Alarm

1) Select [Alarm] key → [Limit 2]

2) Set EtCO2 alarm limit.

8.6.3 Set O2 Compensation

In some cases, such as ventilating with a ventilator, the patient's respiratory gas is mixed with other gases that
interfere with CO2 measurement, and then gas compensation is required to eliminate the interference of these

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 CO2 Monitoring

gases in CO2 measurement. The concentration of gas compensation should be set based on the actual
concentration of interfering gases.
Set gas compensation for CO2 modules as below:
1) Select [Setup] button → [Sensor] → [CO2].
2) Set [O2 Compensation] as below:

MASIMO CO2 Module:

 [High]: The default O2 Compensation is 85%.

 [Medium]: The default O2 Compensation is 50%.
 [Low]: The default O2 Compensation is 21%.

RESPIRONICS CO2 Module:

 Choose the appropriate value according to the O2 content in the measured gas.

COMEN CO2 Module:

 Choose the appropriate value according to the O2 content in the measured gas.

WARNING
 Please set gas compensation based on the actual conditions, or the measurement results may
differ greatly from the actual values to cause misdiagnosis.

8.6.4 Set CO2 Unit

1) Select [Setup] key → [Maintain] → Input the password → [Settings].

2) Select [Unit].
3) Set [CO2 Unit].

8.6.5 Set Altitude

For MASIMO CO2 module, there is no need to set the elevation manually since it is set automatically.
For RESPIRONICS and COMEN CO2 modules:
1) Select CO2 parameter tile or waveform tile to enter [CO2] menu.
2) Select [Setup] tab.
3) Set [Altitude] and [Atmospheric Pressure]: atmospheric pressure will be displayed automatically based
on the elevation altitude value set.

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 CO2 Monitoring

Altitude, Atmospheric Pressure & ETCO2 Table

Altitude Atmospheric Pressure 5% CO2
Feet Meters mmHg EtCO2 mmHg

Sea Level (0) Sea Level (0) 760 38

500 152.4 745 37

750 228.6 738 37

1,000 304.8 731 37

1,500 457.2 717 36

2,000 609.6 704 35

2,500 762 690 35

3,000 914.9 677 34

3,500 1066.8 665 33

4,000 1219.2 652 33

4,500 1371.6 640 32

5,000 1524 628 31

5,500 1676.4 616 31

6,000 1828.8 604 30

6,500 1981.2 593 30

7,000 2133.6 581 29

7,500 2286 570 29

8,000 2438.4 560 28

8,500 2590.8 549 27

9,000 2743.2 539 27

10,000 3048 518 26

10,500 3200.4 509 25

11,000 3352.8 499 25

11,500 3505.2 490 24

12,000 3657.6 480 24

12,500 3810 471 24

13,000 3962.4 462 23

13,500 4114.8 454 23

14,000 4267.2 445 22

14,500 4419.6 437 22

8-11
 CO2 Monitoring

15,000 4572 428 21

15,500 4724.4 420 21

16,000 4876.8 412 21

16,500 5029.2 405 20

16,800 5120.6 400 20

Note: It is assumed that the sea level is of 760mmHg and 0℃, and that the ambient temperature is 0℃ when
calculating barometric pressure based on elevation. For details, please refer to the table.

Warning
 The RESPIRONICS and COMEN CO2 module has no automatic air compensation function.
Set the correct altitude before using the CO2 measurement function for the first time. Incorrect
altitude causes incorrect CO2 reading (5% CO2 error per 1,000m altitude difference).

8.6.6 Set Waveform

Please refer to "Section 5.1.1 Waveform Setting".

8.7 Information on MASIMO Module

8.7.1 CO2 Module LED

LEGI (Light Emitting Gas Inlet) LED indications (Sidestream module):

LED Indicted Status
Remain green Normal system
Flash in green Zeroing…
Remain red Sensor error
Flash in red Please check the sampling line

Status LED on the IRMA probe:

LED Indicted Status
Remain green Normal system
Flash in green Zeroing…
Remain red Sensor error
Flash in red Check adapter

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 CO2 Monitoring

8.7.2 Warning Information

8.7.2.1 ISA Sidestream Gas Analyzer Warning Information

Warning
 The ISA sidestream gas analyzer 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 ISA gas analyzer by the sampling line as it could disconnect from the ISA,
causing the ISA gas analyzer 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 only use sample lines intended for anesthetic agents if N2O and/or anesthetic agents are
being used.
 Do not use T-adapter with infants, as this adds 7 ml dead space to the patient circuit.
 Do not use the ISA gas analyzer with metered-dose inhalers or nebulized medications as this
may clog the bacteria filter.
 Since a successful zeroing requires the presence of ambient air, ensure that the ISA is placed in
a well ventilated place. Avoid breathing near the ISA sidestream gas analyzer before or during
the zeroing procedure.
 Never sterilize or immerse the ISA sidestream gas analyzer in liquid.
 The ISA sidestream gas analyzer is intended only as an adjunct in patient assessment. It must
be used 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 ISA sidestream gas analyzer 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 equipment displays a “Check sampling line” message.
 No modification to the 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 ISA sidestream gas analyzers are not designed for MRI environments.
 During MRI scanning, ISA must be placed outside the MRI suite.
 Use of high frequency electrosurgical equipment in the vicinity of the ISA/medical backboard
equipment may produce interference and cause incorrect measurements.

Caution
 The ISA analyzers should be securely mounted in order to avoid the risk of damage to the ISA.
 Do not operate the ISA sidestream gas analyzer outside the specified operating environment.
 (US Only) Caution: Federal law restricts this equipment 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.

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 CO2 Monitoring

8.7.2.2 IRMA Mainstream Gas Analyzer Warning Information

Warning
 The IRMA analyzers should be securely mounted in order to avoid the risk of damage to the
IRMA.
 Do not operate the IRMA sidestream gas analyzer outside the specified operating environment.
 (US Only) Caution: Federal law restricts this equipment to sale by or on the order of a
physician.
 For professional use. See the instructions for use for full prescribing information, including
indications, contraindications, warnings, precautions and adverse events.
 The IRMA probe is intended for use by qualified medical personnel only.
 The IRMA probe is intended only as an adjunct in patient assessment. It must be used in
conjunction with other assessments of clinical signs and symptoms.
 Disposable IRMA airway adapters shall not be reused. Reuse of the single use adapter can
cause cross infection.
 Used airway adapters shall be disposed of in accordance with local regulations for
biohazardous waste.
 Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6 ml
dead space to the patient circuit.
 Do not use the IRMA Infant airway adapter with adults as this may cause excessive flow
resistance.
 Measurements can be affected by mobile and RF communications equipment. It should be
assured that the IRMA probe is used in the electromagnetic environment specified in this
manual.
 Use of high frequency electrosurgical equipment in the vicinity of IRMA may produce
interference and cause incorrect measurements.
 The IRMA probe is not designed for MRI-environments.
 Do not place the IRMA airway adapter between the endotracheal tube and an elbow as this
may allow patient secretions to block the adapter windows and result in incorrect operation.
 To keep secretions and moisture from pooling on the windows, always position the IRMA probe
in a vertical position with the LED pointing upwards.
 Do not use the IRMA airway adapter with metered dose inhalers or nebulized medications as
this may affect the light transmission of the airway adapter windows.
 Incorrect probe zeroing will result in false gas readings.
 Replace the airway adapter if rainout/condensation occurs inside the airway adapter.
 Use only Masimo manufactured IRMA airway adapters.
 The IRMA probe is not intended to be in patient contact.
 If, for whatever the reason, the IRMA probe is in direct contact with any parts of the infant's
body an insulation material shall be placed between the IRMA probe and the body.
 No modification of this equipment is allowed.

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 CO2 Monitoring

Caution
 Never sterilize or immerse the IRMA probe in liquid.
 The IRMA airway adapters are non-sterile equipment. Do not autoclave the equipment as this
will damage them.
 Do not apply tension to the probe cable.
 Do not operate the IRMA probe outside the specified operating temperature environment.
 (U.S. only) Caution: Federal law restricts this equipment 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.

8.7.3 Airway Obstruction

When the sidestream module gas airway is obstructed, on the screen there will be such a prompt message as
“Sampling Line Clogged”; under such a circumstance, replace the Nomoline sampling line.

Warning
 Do not use the ISA gas analyzer together with a quantitative spraying agent or pulverization
treatment; otherwise it may result in the clogging of the germ filter.

8.7.4 Leakage Test

1) Connect a new Nomoline sampling line with male Luer lock to the ISA gas inlet connector and check
that the gas inlet connector shows a steady green light.
2) Connect a short silicon tubing with an inner diameter of 3/32” (2.4 mm) to the Nomoline male Luer.
3) Exhale a long breath into the silicon tubing until the CO2 concentration is greater than 4.5 vol% or 34
mmHg.
4) Quickly connect the silicon tubing tightly to the exhaust port.
5) Wait for 1 minute until the CO2 concentration has stabilized. Note the value.
6) Wait 1 minute and check that the CO2 concentration has not decreased more than 0.4 vol% or 3 mmHg.
If it has decreased more there is a major leakage in the ISA unit or in the Nomoline. Do not operate the
ISA if there is a major leakage in the unit.

8.7.5 Safety Symbols

Symbol Text, Color Code and Text Format Description

“Warning” indicates the hazardous conditions causing
Warning: additional
information. possible personal injuries or death. The warning
symbol should comply with ISO 7010-W001.
User’s Manual Refer to the User’s Manual.
Reference No. /
Serial No. /

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 CO2 Monitoring

Lot No. /
Valid until [YYYY-MM-DD] Do not use the equipment after such date.

Temperature limit /

Pressure limit /

RH limit /

No reuse /
Recycle this electrical and electronic equipment
WEEE directive
according to 2002/96/EC.
Contain Pb /
The IP grade indicates the water ingress protection
IP grade
performance.
IP grade against water and solid Protection against tools and short cable ends (>1mm).
object ingress Protection against water sprays from all directions.
Warning (U.S.): the equipment shall be sold by
Sold on prescription only medical practitioners or on prescription according to
U.S. federal laws.

CO2 The IRMA/ISA analyzer measures CO2 only.

Multiple gases (AX+ or OR+) The IRMA/ISA analyzer can measure multiple gases.

Gas inlet /

Gas (exhaust) outlet /

Illustrate the connection between Nomoline and
Connect to patient circuit
patient circuit.
Connect to ISA Illustrate the connection between Nomoline and ISA.

Not sterile, latex free The equipment is latex free and not sterile.

8.7.6 Patents and Trademarks

(1) Patent Statement

Masimo Sweden AB owns the following patents for relevant products described in this operating
instruction manual: SE519766; SE519779; SE523461; SE524086. Other patents are being applied.
(2) Trademark
Masimo IRMA™, Masimo ISA™, Masimo XTP™, Sigma Multigas Technology™, LEGI™,
Nomoline™, IRMA EZ Integrator™, Masimo GasMaster™ and ISA MaintenanceMaster™ are
trademarks of Masimo Sweden AB.

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 CO2 Monitoring

8.7.7 Consumables

8.7.7.1 ISA Nomoline Family

ISA 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 and infant patients.
The Nomoline Family sampling lines incorporate a unique water separation (NO MOisture) section, which
can remove the 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 ISA gas analyzer remains in a low-power sleep mode. Once the
sampling lineis connected, the ISA gas analyzer 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
spontaneously breathing patients and in both disposable and reusable configurations. For instance, the
disposable Nomoline Airway adapter Set or a combination of the reusable Nomoline Adapter and a disposable
Nomoline Extension / T-adapter, is available for the intubated patient. For spontaneously breathing patients,
similarly a disposable Nomoline Nasal CO2 Cannula or a combination of the reusable Nomoline Adapter and
a disposable Nomoline Nasal CO2 Cannula (with Luer Connector) can be applied.

OR

Fig 8-1 ISA Nomoline Family

The disposable Nomoline Airway Adapter Set is an alternative to the combination of the reusable Nomoline
Adapter and a disposable Nomoline Extension / T-adapter.
The Nomoline Adapter may be used with other third-party sampling lines and cannulas. However, note that
the Nomoline Family sampling lines are designed for optimal performance and measurement fidelity when
used with the ISA gas analyzers. 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)

Fig 8-2 T-adapters

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 CO2 Monitoring

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 tubes or cannulas with larger inner diameter than 1 mm will increase the response
time of ISA system.

Nomoline Family sampling line replacement

Nomoline Family sampling lines should be replaced according to good clinical practice or when the sampling
line gets occluded. Occlusion occurs when water, secretion etc. is aspired from the respiratory circuit to such
extent that ISA cannot maintain the normal 50 sml/min sample flow. This situation is indicated by a red
flashing gas of inlet connector and an alarm message “Sampling Line Clogged”; Replace the Nomoline and
wait until the gas inlet connector switches to green indicating that the ISA gas analyzer is ready for use.

8.7.7.2 IRMA Airway Adapter

The IRMA airway adapter is inserted between the endotracheal tube and the Y-piece of the breathing circuit.
The respiratory gas measurements are obtained through the XTP™ windows in the sides of the adapter. The
XTP windows are transparent to light in the wavelength ranges of interest and they are specially designed
using the latest advances in material technology to provide a window minimizing the impact of water vapor
on light transmission.

Warning
 Replace the airway adapter if rainout/condensation occurs inside the airway adapter.

The IRMA airway adapter is designed as a non-sterile single patient use disposable for Adult/Pediatric and
Infant applications. The IRMA Infant airway adapter has specially designed connectors for minimizing the
dead space and can be used even for very small patients.

IRMA airway adapters: Adult/Pediatric (REF: 106220) and Infant (REF: 106260)

Warning
 Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6 ml
dead space to the patient circuit.
 Do not use the IRMA Infant airway adapter with adults as this may cause excessive flow
resistance.

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 CO2 Monitoring

8.7.8 Maintenance

The user should verify gas readings regularly; If any problem, contact an engineer of the manufacturer for
maintenance.

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 Chapter 9 SpO2 Monitoring (Available for V3 Only)

9.1 Overview

The SpO2 plethysmography measures the arterial SpO2, namely, the percentage of the oxyhemoglobin count.
The SpO2 is measured with the pulse oximetry; a continuous noninvasive method measuring how many of the
lights emitted from the sensor (light source) can penetrate the patient’s tissues (fingers or ears) and reach the
receiver.
The ventilator measures the following parameters:
Arterial SpO2: the ratio of the oxyhemoglobin to the sum of oxyhemoglobin and non-oxygenated hemoglobin
(functional arterial SpO2);
Pleth waveform: a visible indication of the patient’s pulse;
PR (calculated from pleth waveform): The pulse rate is calculated and the display (beats per minute) and is
updated at a frequency of once per second. The upper and lower alarm limits are also displayed next to the
pulse rate measurement.
PI (perfusion index, not for Nellcor SpO2): The Perfusion Index indicates numerically the percentage of
pulsatile signal to non-pulsatile signal (pulse strength).

WARNING
 If there is any carboxyhemoglobin (COHb), methemoglobin (MetHb) or dye dilution chemical, the
SpO2 value will have a deviation.

9.1.1 Identification of SpO2 Sensor Type

The SpO2 sensor type is pre-configured before the ventilator is delivered. You can identify it based on the
silkscreened logo beside the original SpO2 sensor below the left side sensor connector of the ventilator:

 Comen SpO2 sensor:

Sensor connector: circular connector;

Silkscreened logo: SpO2.

 Masimo SpO2 sensor:

Sensor connector: circular connector;

Silkscreened logo: MasimoSET.

 Nellcor SpO2 sensor:

Sensor connector: circular connector;

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 SpO2 Monitoring

Silkscreened logo: Nellcor.

The information about wavelength range and maximum optical output power of the sensor is useful to the
clinician for some therapy, for example, photodynamic therapy.

 The Comen SpO2 sensor can measure a wavelength of 660nm (red LED) or 905nm (IR LED).

 The Masimo SpO2 sensor can measure a wavelength of 660nm (red LED) or 905nm (IR LED).

 The Nellcor SpO2 sensor can measure a wavelength of 660nm (red LED) or 905nm (IR LED).

 The maximum optical output power of the sensor is lower than 15mW.

Warning
 The ventilator can automatically recognize the SpO2 sensor type. However, the ventilator is
configured with a specific internal SpO2 hardware before delivery, the ventilator cannot
measure SpO2 if using a incompatible sensor.

Note
 Functional test equipment or SpO2 simulator cannot be used to verify the accuracy of SpO2
monitor and pulse oximeter sensor. The accuracy of SpO2 monitor and pulse oximeter sensor
needs to be verified by clinical data.
 Functional test equipment or SpO2 simulator can be used to evaluate the accuracy of PR.
 This ventilator and the specified SpO2 sensor and cable extenders listed in this instruction for
use have been tested for compliance with ISO 80601-2-61.

9.2 Safety Instructions

Warning
 The ventilator is compatible with the SpO2 sensor designated by Comen only. Before monitoring
the patient, check the sensor and extension cord are compatible with the ventilator. Incompatible
accessories reduce the performance of the ventilator.

 Before monitoring the patient, check the sensor cable works properly. Remove the SpO2 sensor
cable from the sensor interface and the ventilator displays the prompt message “SpO2 Finger
off” and triggers the alarm sound.

 If the SpO2 sensor or its package seems damaged, do not use it. Return the damaged product to
the manufacturer.

 The patients who are allergic to the rubber materials shall not use SpO2 probe.

 Long-time continuous monitoring increases the risk of undesired skin characteristic changes
(extremely sensitive, turning red, blistered or pressure necrosis), especially for the patients with

9-2
 SpO2 Monitoring

perfusion disorder or variable or immature skin morphology diagram. Align the sensor with the
light path, adhere the sensors properly and check the sensors position regularly based on skin
quality (change the sensor position when the skin quality decreases). Perform such check
frequently if necessary (subject to the condition of the patient).

 Make sure the sensor cable and the electrosurgical equipment cable are not intertwined.

 Do not place the sensor on a limb with ductus arteriosus or intravenous tube.

 Setting the high SpO2 alarm limit to 100% disables the high-limit alarm. Premature infants may
get infected with crystalline posterior fibrous tissue diseases in case of high SpO2. Please set the
high SpO2 alarm limit cautiously based on recognized clinical practices.

 The pulse oximeter is to be operated by, or under the supervision of, qualified personnel only.
The manual, accessories, directions for use, all precautionary information, and specifications
should be read before use.

 As with all medical equipment, carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.

 Do not place the pulse oximeter or accessories in any position where it might fall on the patient.

 Do not start or operate the pulse oximeter unless the setup was verified to be correct.

 Do not use the pulse oximeter during magnetic resonance imaging (MRI) or in an MRI
environment.

 Do not use the pulse oximeter if it appears or is suspected to be damaged.

 Explosion hazard: Do not use the pulse oximeter in the presence of flammable anesthetics or
other flammable substances in combination with air or nitrous oxide or in oxygen-enriched
environment.

 To ensure safety, avoid stacking multiple equipment or placing anything on the equipment
during operation.

 To protect against injury, follow the directions below:

 Do not soak or immerse the equipment in liquids.

 Do not attempt to sterilize the equipment.

 Use cleaning solutions only as instructed in this operator's manual.

 Do not attempt to clean the equipment while monitoring a patient.

 To protect from electric shock, always remove the sensor and completely disconnect the pulse
oximeter before bathing the patient.

 If any measurement seems questionable, first check the patient’s vital signs by alternate means
and then check the pulse oximeter for proper functioning.

 Inaccurate SpO2 readings may be caused by:

9-3
 SpO2 Monitoring

 Improper sensor application and placement.

 Elevated levels of COHb or MetHb: High levels of COHb or MetHb may occur with a
seemingly normal SpO2. When elevated levels of COHb or MetHb are suspected, laboratory
analysis (CO-Oximetry) of a blood sample should be performed.

 Elevated levels of bilirubin.

 Elevated levels of dyshemoglobin.

 Vasospastic disease, such as Raynaud’s, and peripheral vascular disease.

 Hemoglobinopathies and synthesis disorders such as thalassemias, such as thalassemias,

Hbs, Hbc, sickle cell, etc.

 Hypocapnic or hypercapnic conditions.

 Severe anemia

 Very low arterial perfusion.

 Extreme motion artifact.

 Abnormal venous pulsation or venous constriction.

 Severe vasoconstriction or hypothermia.

 Arterial catheters and intra-aortic balloon.

 Intravascular dyes, such as indocyanine green or methylene blue.

 Externally applied coloring and texture, such as nail polish, acrylic nails, glitter, etc.

 Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal fingers.

etc.

 Skin pigment disorders.

 Interfering Substances: Dyes or any coloring substance that can change usual blood
pigmentation may cause erroneous readings.

 The pulse oximeter should not be used as the sole basis for medical decisions. It must be used in
conjunction with clinical signs and symptoms.

 The pulse oximeter is not an apnea monitor.

 The pulse oximeter may be used during defibrillation, but this may affect the accuracy or
availability of the parameters and measurements.

 The pulse oximeter may be used during electrocautery, but this may affect the accuracy or
availability of the parameters and measurements.

 The pulse oximeter should not be used for arrhythmia analysis.

 SpO2 is empirically calibrated in healthy adult volunteers with normal levels of

carboxyhemoglobin (COHb) and methemoglobin (MetHb).

 Do not adjust, repair, open, disassemble, or modify the pulse oximeter or accessories. Injury to

9-4
 SpO2 Monitoring

personnel or equipment damage could occur. Return the pulse oximeter for service if necessary.

 Don't clip oxygen saturation probe on the same position for long period. Check the patient’s skin
every two hours to ensure good skin quality and lighting. In case of any skin change, move the
sensor to another part. Change the wearing part at least every four hours.

 During a technical alarm condition, the SpO2 monitoring, both displayed values and waveform
might not accurate, and the operator should additionally validate the values and the patient’s
status.

Cautions
 Do not place the pulse oximeter where the patient can control it.

 Electrical shock and flammability hazard: Before cleaning, always turn off the equipment and
disconnect from any power supply.

 When patients are undergoing photodynamic therapy they may be sensitive to light sources.
Pulse oximeter may be used only under careful clinical supervision for short time periods to
minimize interference with photodynamic therapy.

 Do not place the pulse oximeter on electrical equipment that may affect the normal work of the
oximeter equipment

 If SpO2 values indicate the possibility of the hypoxemia, a laboratory blood sample should be
taken to confirm the patient’s condition.

 If using pulse oximeter during full body irradiation, keep the sensor out of the radiation field. If
the sensor is exposed to the radiation, the reading might be inaccurate or the equipment might
be zero for the duration of the active irradiation period.

 To ensure that alarm limits are appropriate for the patient monitored, check the limits each time
the pulse oximeter is used.

 Variation in measurements may be profound and may be affected by sampling technique as well
as the patient's physiological conditions. Any results exhibiting inconsistency with the patient’s
clinical status should be repeated and/or supplemented with additional test data. Blood samples
should be analyzed by laboratory instruments prior to clinical decision made to completely
understand the patient’s condition.

 Do not submerge the pulse oximeter in any cleaning solution or attempt to sterilize by autoclave,
irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the pulse
oximeter.

 Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of
patient-applied circuits and the system are within acceptable limits as specified by the applicable
safety standards. The summation of leakage currents must be checked and in compliance with
IEC 60601-1 and UL60601-1. The system leakage current must be checked when connecting

9-5
 SpO2 Monitoring

external equipment to the system. When an event such as a component drop of approximately 1
meter or greater or a spillage of blood or other liquids occurs, retest before further use. Injury
to personnel could occur.

 Disposal of product - Comply with local laws in the disposal of the equipment and/or its
accessories.

 To minimize radio interference, other electrical equipment that emits radio frequency
transmissions should not be in close proximity to the pulse oximeter.

Notes
 High-intensity extreme lights (such as pulsating strobe lights) directing on the sensor may not
allow the pulse oximeter to provide vital sign readings.

 Pulse oximeter is calibrated to display functional blood oxygen saturation.

 The displayed SpO2 waveform is normalized.

Masimo SpO2 Specific Information

Cautions
 If the Low Perfusion message is frequently displayed, find a better perfused monitoring site. In
the interim, assess the patient and, if indicated, verify oxygenation status through other means.

 Replace the cable or sensor if the instructions in the manual after firstly tried don't work when a
low SIQ message is displayed in the process of consistently monitoring patients. after completing
troubleshooting steps listed in this manual.

Notes
 When using the Maximum Sensitivity setting, performance of the "Sensor Off" detection may be
compromised. If the equipment is in this setting and the sensor becomes dislodged from the
patient, the potential for false readings may occur due to environmental "noise" such as light,
vibration, and excessive air movement.

 Do not loop the patient cabling into a tight coil or wrap around the equipment, as this can
damage the patient cabling.

 Additional information specific to the Masimo sensors compatible with the pulse oximeter,
including information about parameter/measurement performance during motion and low
perfusion, may be found in the sensor's directions for use (DFU).

 Cables and sensors are provided with X-Cal™ technology to minimize the risk of inaccurate
readings and unanticipated loss of patient monitoring. Refer to the Cable or Sensor DFU for the
specified duration of the patient monitoring time.

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 SpO2 Monitoring

9.3 SpO2 and PR Accuracy Test

Assess the SpO2 accuracy by comparing the readings respectively on the monitor and Index-2 SpO2 simulator
of FLUKE.
The reference method for the computation of pulse rate accuracy is electronic pulse simulator.

Warning
 A functional tester cannot be used to assess the accuracy of the pulse oximeter.

9.4 Measurement Restrictions

In operations, the following factors may affect the SpO2 measurement accuracy:

1) High-frequency radio interference, whether from the ventilator or from the electrosurgical equipment
connected to the ventilator. To minimize radio interference, other electrical equipment that emits
high-frequency transmission should not be in close proximity to the ventilator.

2) Do not use the oximeter or SpO2 sensor during MRI scanning, or the induced current may cause burns.

3) Intravenous dyes.

4) The patient moves frequently.

5) Ambient ray radiation.

6) The sensor is fixed improperly or in an improper position on the patient.

7) Improper sensor temperature.

8) The sensor is placed on a limb with blood pressure cuff, ductus arteriosus or intravenous tube.

9) Concentration of the non-functional hemoglobin, like COHb or MetHb.

10) Low SpO2.

11) Poor circulation perfusion at the tested part.

12) The shock, anemia, hypothermia and vasoconstrictors may reduce the arterial blood flow to a level that is
not measureable.

13) The SpO2 measurement accuracy depends also on the absorption of the lights with special wavelength by
oxyhemoglobin and reduced hemoglobin. If any other substance also absorbs such lights, like COHb,
MetHb, methylene blue or indigo carmine, you may obtain a false or low SpO2 value.

9.5 SpO2 Display

The waveform is show on the displayer while the monitoring values is under the [Monitoring Value Interface].
See 4.4 Monitoring Value Interface.

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 SpO2 Monitoring

Masimo
(3) (4) (5) (6)

(1) (7)

(2) (8)
(9)

Nellcor (10) (5) (6)

(7)
(1) (8)
(9)

(12) (11) (10)

Comen (3) (4) (5) (6)

(7)
(1)
(8)
(2) (9)

(1) SpO2 Waveform (11) (10)

(2) Signal Identification and Quality (For Masimo and Comen SpO2): the height of the vertical line
represents the quality of the measured signal.
(3) PI Value
(4) PI Unit
(5) SpO2 Value: The display will show dashed lines when the probes not connected or technical failure
occurs. When the displayed SpO2 value is potentially incorrect (such as “!SpO2 low signal”), .a symbol
would appear next to the SpO2 value.
(6) SpO2 Unit
(7) SpO2 alarm limit
(8) PR Unit
(9) PR alarm limit
(10) PR value
(11) Pulse Amplitude Indicator (blip bar) (For Comen and Nellcor SpO2): Indicates pulse beat and shows the
relative pulse amplitude. As the detected pulse becomes stronger, more bars light with each pulse.

(12) SatSeconds Indicator (For Nellcor SpO2): Fills in clockwise as the SatSeconds alarm management
system detects a %SpO2 reading outside of the limit setting. Empties in counterclockwise direction
when %SpO2 reading is within limits. When the indicator is full, a medium or high priority alarm sounds.

9-8
 SpO2 Monitoring

9.6 Monitoring Steps

Warning
 Place the SpO2 sensor properly based on the SpO2 sensor type.

 When changing application sites, or reattaching sensor, first disconnect sensor from the
patient cable.

9.6.1 Comen SpO2 Measurement Steps

1) Choose a proper SpO2 sensor according to the patient type.

2) Fix the sensor to an appropriate position on the patient. Please refer to "Section 9.7 Placement of SpO2
Sensor" for more information.
3) Insert SpO2 cable connector into the SpO2 interface of the ventilator.
4) Set [Monitoring] to turn on, please refer to "Section 9.8.1 SpO2 Monitoring Setting".

9.6.2 Masimo SpO2 &Nellcor SpO2 Measurement Steps

1) Choose a proper SpO2 sensor according to the module type and patient type.
2) Fix the sensor to an appropriate position on the patient. Please refer to "Section 9.7 Placement of SpO2
Sensor" for more information.
3) Connect SpO2 patch cord to SpO2 sensor.
4) Insert the other end of SpO2 patch cord into the SpO2 interface of the ventilator.
5) Set [Monitoring] to turn on, please refer to "Section 9.8.1 SpO2 Monitoring Setting".

9.7 Placement of SpO2 Sensor

Warning
 Check the patient’s skin every two hours to ensure good skin quality and lighting. In case of any
skin change, move the sensor to another part. Change the wearing part at least every four hours.

9.7.1 Placement of Adult SpO2 Sensor

The location of Adult SpO2 sensor is shown as the figure below:

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 SpO2 Monitoring

9.7.2 Placement of Pediatric SpO2 Sensor

1) Assembly of Pediatric SpO2 sensor: Embed the LED end and PD end of the Y-shaped SpO2 sensor
respectively in the upper and lower groove of the NEO SpO2 sensor sheath, as shown in the figure below:

(1)
(1)

(1) Y-shaped SpO2 Sensor (2) SpO2 Sensor Sheath

2) Placement of SpO2 sensor: fix it on the finger of pediatric patient.

9.7.3 Placement of Disposable SpO2 Sensor

Fig. 1 Fig. 2 Fig. 3

Fig. 4

1) For fragile skin, the stickiness of the medical grade adhesive can be diminished or eliminated by daubing
the adhesive areas with a cotton ball or with gauze (Refer to Fig. 1).
2) Direct the sensor cable so that it either points away from the patient or runs along the bottom of the foot.
Apply the detector onto the fleshy part of the lateral aspect of the sole of the foot aligned with the fourth

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 SpO2 Monitoring

toe. Alternatively, the detector may be applied to the top of the foot (not shown). Complete coverage of
the detector window is needed to ensure accurate data (Refer to Fig. 2).
3) Wrap the adhesive/foam wrap around the foot and ensure that the emitter window (red star) aligns
directly opposite of the detector (Refer to Fig. 3). Be careful to maintain proper alignment of the detector
and emitter windows while attaching adhesive/foam wrap to secure the sensor.
4) Verify correct positioning and reposition if necessary (Refer to Fig. 4).

9.8 SpO2 Setup

9.8.1 SpO2 Monitoring Setting

1) Select [Setup] key → [Sensor] → [SpO2] tab.

2) Set [Monitoring] to turn on/off the SpO2 monitoring function.

9.8.2 Open SpO2and PR Alarm

1) Select [Alarm] key → [SpO2]

2) Open SpO2 and PR.
: Alarm open state.
: Alarm off state.

9.8.3 Set SpO2 Alarm Level

1) Select [Alarm] key → [SpO2]

2) Select the drop-down box on the right of [SpO2 High Level] to set the alarm level of SpO2 upper limit.
3) Select the drop-down box on the right of [SpO2 low Level] to set the alarm level of SpO2 lower limit.

9.8.4 Set PR Alarm Level

1) Select [Alarm] key → [SpO2]

2) Select the drop-down box on the right of [PR High Level] to set the alarm level of PR upper limit.
3) Select the drop-down box on the right of [PR low Level] to set the alarm level of PR lower limit。

9.8.5 Set SpO2 Alarm

1) Select [Alarm] key → [SpO2]

2) Set SpO2 alarm limits.

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 SpO2 Monitoring

9.8.6 Set PR Alarm

1) Select [Alarm] key → [SpO2]。

2) Set PR alarm limits。

9.8.7 Set Waveform Speed

1) Select [Setup] → [Sensor] → [SpO2].

2) Set [Sweep Speed] to the appropriate value.

9.8.8 Set Pulse Volume

1) Select [Setup]→[Sensor]→[SpO2].
2) Set [Smart Pulse Sound]. Volume characteristic: beep。
When there is a valid SpO2 measurement value, the system will also adjust the pulse tone (Pitch Tone)
according to the value of SpO2。

9.8.9 Set Sensitivity (Available for Masimo SpO2 Only)

[Sensitivity] can be set to [Normal], [High] or [APOD]. [High] represents the highest sensitivity. In typical
monitoring conditions, please select [Normal]. If the sensor is likely to come off the patient due to wet skin,
violent movements or other causes, please select [APOD]. If the patient's perfusion level is extremely low,
please select [High] to increase the sensitivity.
Steps to set [Sensitivity]:
1) Select [Setup]→[Sensor]→[SpO2].
2) Select an appropriate [Sensitivity] for Masimo SpO2: [Normal], [High] or [APOD].

9.8.10 Set Smart Pulse Sound (Available for Masimo SpO2 Only)

You will / won't hear the PULSE tone in case of unstable signal or ambient noise if this function is enabled /
disabled.

Set [Smart Pulse Sound]:

1) Select [Setup]→[Sensor]→[SpO2].
2) Turn on or off [Smart Pulse Sound].

9.8.11 Set SatSeconds(Available for Nellcor SpO2 Only)

1) Select [Setup]→[Sensor]→[SpO2].
2) Set [SatSeconds] to the appropriate time.

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 SpO2 Monitoring

The smart alarm is designed to reduce false alarms and keep the clinician informed of the SpO2 changes more
accurately and timely. For example, if you set [SatSeconds] to [50] and the upper and lower alarm limit of
NELLCOR SpO2 Respectively to 97% and 90%, maintain the measured SpO2 value at 80% for 3s and then
reduce it to 78% for 2s, the ventilator will trigger the alarm sound and indicator 5s after the SpO2 value goes
beyond the alarm limit and the circle beside the SpO2 value will return to the origin.
Calculation method:
Percentage points × seconds = SatSeconds (integer)
The calculated SatSeconds is displayed as follows:
%SpO2 Seconds SatSeconds
（90%-80%）× 3= 30
（90%-78%）× 2= 24
Total SatSeconds = 54

In the above SatSeconds example:

About 4.9s later, the ventilator will report a SatSeconds alarm because you've set [SatSeconds] to [50], smaller
than 54.
The SpO2 value may fluctuate in seconds rather than remain unchanged. The patient's SpO2 value usually
fluctuates within the alarm limit and sometimes goes beyond the alarm limit discontinuously. The ventilator
will accumulate the positive and negative percentage points until the set value of [SatSeconds] is reached or the
patient's SpO2 value remains beyond the alarm limit.

9.8.12 Set Average Time

The SpO2 value displayed on the ventilator is the average of the SpO2 values acquired in a given time. Shorter
(longer) average time will lead to quicker (slower) response and lower (higher) measurement accuracy of the
ventilator when the patient’s SpO2 value changes. For a critical patient, please set a short average time so as to
analyze his/her condition timely. Set average time:

9.8.12.1 Set Masimo SpO2 Average Time

1) Select [Setup]→[Sensor]→[SpO2]
2) Select an appropriate [Average Time]: [2-4s], [4-6s], [8s], [10s], [12s], [14s] or [16s].

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 SpO2 Monitoring

9.8.12.2 Set Comen SpO2 Average Time

1) Select [Setup]→[Sensor]→[SpO2]
2) Select an appropriate [Sensitivity]: [High] (4s), [Middle] (8s) or [Low] (16s).

9.8.13 Set Nellcor SpO2 Average Time

For Nellcor SpO2, the average time is not adjustable, default at 11 seconds.

9.8.14 Set Signal Indication(Unavailable for Nellcor SpO2 Only)

The magnitude of the SpO2 SIQ waveform provides an assessment of the confidence in the measurement
displayed. A higher value indicates higher confidence in the measurement whereas a smaller value indicates
lower confidence in the displayed measurement.

Movements usually affect the signal quality. When the arterial pulse reaches the peak, the ventilator marks its
location on the vertical line (signal indicator).

The height of the vertical line represents the quality of the measured signal (the higher line, the higher quality).
Set [Signal Indication] (Signal Identification and Quality):
1) Select [Setup]→[Sensor]→[SpO2]
2) Select [Signal Indication] to switch between [ON] and [OFF].

9.8.15 Fast Sat

FastSat enables rapid response to, and display of, fast changes in SpO2 by giving priority to the most recent
data. This aids the clinician in clinical settings requiring fast response time such as those seen with induction,
intubation, sleep studies and resuscitation.
1) Select [Setup]→[Sensor]→[SpO2].

2) Select [Fast Sat] (Fast Saturation) to switch between [On] and [Off].

Note: this function is available for Masimo SpO2 only; if this function is enabled, you can find the
prompt message “Fast Sat” at the main interface.

9.9 Masimo Information

1) Masimo Patent Information

Masimo Patents: www.masimo.com/patents.htm

2) No Implied License Statement

Possession or purchase of this device does not convey any express or implied license to use the device with
unauthorized sensors or cables which would, alone or in combination with this device, fall within the scope of
one or more of the patents relating to this device.

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 SpO2 Monitoring

3) Other Information

©2006 Masimo Corporation. Masimo, Radical, Discrete Saturation Transform, DST, Satshare, SET, LNOP,
LNCS and LNOPv are federally registered trademarks of Masimo Corporation.
RadNet, Radicalscreen, signal IQ, FastSat, fastStart and APOD are trademarks of Masimo Corporation.

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 Chapter 10 Other functions

10.1 Manual Breath

Select [Tools] key → [Function] → [Manual Breath]; then the ventilator will perform gas supply once under
the current ventilation mode.

Note
 If press [Manual Breath] key during the inspiratory phase, the manual ventilation action will
not be triggered.

 In CPAP ventilation mode, the manual ventilation function cannot be activated. If apnea
ventilation occurs, the manual ventilation will be supported.

 In standby mode, the system cannot activate the manual ventilation function.

10.2 Expiratory Hold

Expiratory hold is to stop the patient’s inspiration within certain time in order to extend the patient’s
expiratory phase time.
1) Select [Tools] button → [Function];
2) Press and hold [Exp. Hold] key. The ventilator will activate the expiratory hold function and prompt the
message of [Exp. Hold Active].
3) Release the [Exp. Hold] key. The corresponding function will be terminated.
The maximum duration of expiratory hold is 30s. When the [Exp. Hold] key is pressed and hold more than
30s or released, the ventilator will terminate the expiratory hold function automatically.
During the expiratory hold period, PEEPi will be automatically calculated displayed in the message dialog as
in the picture.

Note
 There is at least one inspiratory phase between two expiratory holds.

 Only in the non-standby mode, can the system respond to the action of pressing [Exp. Hold]
key.

 In CPAP ventilation mode, the EXP. HOLD function cannot be activated. If apnea ventilation
occurs, the expiratory hold will be supported.

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 Other functions

10.3 Inspiratory Hold

Inspiratory hold is to stop the patient’s expiration within certain time in order to extend the patient’s
inspiratory phase time.
1) Select [Tools] key → [Function].
2) Press and hold [Insp. Hold] key. The ventilator will activate the inspiratory hold function and prompt the
message of [Insp. Hold Active].
3) Release the [Insp. Hold] key. The corresponding function will be terminated.
The maximum duration of inspiratory hold is 30s. When the [Insp. Hold] key is pressed and hold more than
30s or released, the ventilator will terminate the inspiratory hold function automatically.
During the inspiratory hold period, Cstat and Pplat will be automatically calculated displayed in the message
dialog as in the picture.

Note:
 There is at least one expiratory phase between two inspiratory holds.

 Inspiratory hold is disabled in standby and O2 therapy status

 In CPAP ventilation mode, the Insp. Hold function cannot be activated. If apnea ventilation
occurs, the inspiratory hold will be supported.

 The maximum “Inspiratory Pause (%)” is 6.0 s.

 The inspiratory pause can be used to synchronize radiographic imaging with lung inflation or
used for a recruitment manoeuvre (a temporary increase in pressure intended to expand the
lung).

10.4 O2↑ (O2 Enrichment)

O2↑, also called oxygen enrichment, refers to the ventilation of higher O2 concentration than normal in a
specified period. When the patient type is Adult, O2 concentration is set with 100% When the patient type is
PED, O2 concentration is set with 100% or current O2 concentration times 1.25, whichever is smaller.
1) When [O2↑ Suction] key is selected, the ventilator will activate the function of Oxygen enrichment.
2) The indicator corresponding to [O2↑ Suction] button will be kept on, and the remaining time of this
action will be displayed in the system prompt message area.
3) The maximum duration of oxygen enrichment is 2min. During the period of oxygen enrichment, the
currently set O2 concentration is displayed as the [O2%] parameter value in the parameter setting hotkey
area.
When oxygen enrichment is active for more than 2 min, or [O2↑ Suction] key is selected again, the ventilator
will terminate the function of Oxygen enrichment.

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 Other functions

Note
 In Standby mode, the system cannot activate the O2↑ (oxygen enrichment) function.

 When O2 source type is low-pressure O2, O2↑ will not be activated and the prompt “Fail to
Start with low Pressure O2 Supply” will be displayed even if the [O2↑ Suction] key is clicked.

 If the breathing tube is disconnected during oxygen enrichment, the Suction function will be
activated. Refer to "Section 10.5 Sputum Suction" for more information.

10.5 Suction

Sputum suction refers to the function that the ventilator assists the user by sucking sputum of the patient. The
device automatically detects user’s disconnection and connection of the patient circuit. Oxygen enrichment is
applied before and after suction, and all physiological alarms are blocked during suction.
1) Click [O2↑ Suction] button, and the system will perform oxygen enrichment function in ventilation of the
patient, and will check whether the patient circuit is disconnected in the 120s ventilation. Then
disconnect the patient circuit.
2) After the patient circuit is disconnected, the system will prompt [Patient tube disconnected. Reconnect
the patient after completing sputum suction.] and terminate the ventilation. At this moment, manual
suction can be performed against the patient.
3) After the operation towards the patient is completed, connect the patient circuit. The system will perform
O2↑ ventilation if detecting the circuit is connected.
During O2↑ ventilation, press [O2↑ Suction] key to terminate this operation.

Note
 When suction is started, P0.1, PEEPi and NIF cannot be activated.

10.6 Nebulizer

Nebulizer is used to nebulize medicine as aerosol which is inhaled by the patient to achieve the treatment
purpose.
1) Select [Nebulizer] key.
2) Set [Time] (1min-60min) in the displayed menu with the knob. Press the knob to confirm and then click
[Start], nebulizing function will be activated. When the nebulizing function is activated, the remaining
time will be displayed in the system prompt message area.
When the nebulizing time is ended or [Nebulizer] key is pressed again, the ventilator will terminate this
function.

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 Other functions

Note
 CO2 cannot be measured in environments exposed to aerosols. After the nebulizing function is
activated, sampling and monitoring of CO2 modules will be suspended.

 In Standby mode, the system cannot activate the nebulizing function.

 When the patient type is Pediatric, in V-A/C, V-SIMV, PRVC-SIMV or PRVC mode, the
Nebulizing function is invalid.

 When O2 source type is low-pressure O2, nebulizing will not be activated and the prompt “Fail
to Start with low Pressure O2 Supply” will be displayed even if the [Nebulizer] key is clicked.

 Nebulized drugs may block expiratory filters and the flow sensor within a short time, please
carry out check and cleaning after nebulization.

 Nebulizing can result in fluctuation of the patient’s FiO2.

 If the inspiratory flow is less than 15 l/min, the nebulization flow of the ventilator is zero.

10.7 P0.1

P0.1 refers to the pressure drop within the initial 100ms after the patient begins spontaneous breathing.
1) Select [Tools] key → [Diagnostics] → [P0.1].
2) Select [P 0.1] button to enter the P0.1 measuring interface.
3) If [Start] button is selected in the opened interface, the system will perform the P0.1 measurement and
prompt the message [Measurement in progress…].
4) After measurement, the system will display the measured result. The ventilator can display the last 3
measurement results.
5) The waveform and loop data will be freeze automatically after measurement is finished.

Note
 When P0.1 is started, Suction, PEEPi and NIF cannot be activated.

 During P0.1 measurement, the system will not perform freezing after the " " [Freeze] button
is clicked.

 In the P0.1 Measurement interface, if no operation is performed within 3 min, the system will
automatically exit this interface.

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 Other functions

10.8 PEEPi

The PEEPi measurement function supports the measurement of PEEPi (Endogenous PEEPi) and Vtrap. PEEPi
refers to the Intrinsic Positive End-Expiratory Pressure produced by trapped gas. Vtrap refers to the volume of
trapped gas.
1) Select [Tools] key → [Diagnostics].
2) Select [PEEPi] button to enter the Intrinsic Positive End-Expiratory Pressure (PEEPi) measuring
interface.
3) If [Start] button is selected in the opened interface, the system will perform the Intrinsic Positive
End-Expiratory Pressure (PEEPi) measurement and prompt the message [Measurement in progress…].
4) After measurement, the system will display the measured result. The ventilator can display the last 3
measurement results.
5) The waveform and loop data will be freeze automatically after measurement is finished.

Note

 When the PEEPi is being in measurement, the system will not perform freezing after the " "
[Freeze] button is clicked.

 When the PEEPi is being in measurement, the functions of manual breath, inspiratory hold
and expiratory hold are disabled.

 In the PEEPi Measurement interface, if no operation is performed within 3 min, the system will
automatically exit this interface.

10.9 NIF

NIF refers to the maximum Negative Inspiratory Force produced by the patient’s spontaneous breathing in a
specified period.
1) Select [Tools] key → [Diagnosis].
2) Select [NIF] button to enter the NIF measuring interface.
3) Press and hold [Exp. Hold] button in the opened interface; the system will start NIF measurement.
4) Release the [Exp. Hold] button to finish the measurement; then the system will display the measured
result. The ventilator can display the last 3 measurement results.

Note
 In the NIF Measurement interface, if no operation is performed within 3 min, the system will
automatically exit this interface.

 When the PEEP is set at Off, and the patient spontaneous breathing accompanying with
subatmospheric pressure of -10cmH2O, the maximum negative pressure can be -10cmH2O.

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 Other functions

10.10 P-V Tools

Mechanical ventilation with the best PEEP setting can improve oxygenation and LMC and reduce lung injury.
P-V tool is used to plot the static pressure-volume curve (static P-V loop) and then determine the best PEEP
according to the feature points on the P-V loop. Doctors can use this function to determine the best PEEP for
each patient.

Note
 The P-V tool function is disabled in such cases: patient type being PED; in CPAS/PSV,
non-invasive and apnea ventilation modes; in the O2↑ (oxygen enrichment) process; in the P0.1
measuring being in progress, in the process of nebulizing or sputum suction or within 1min
after the it is finished; within 1min after the last P-V loop test is finished.

 It is not suggested to use the P-V Tool function when there is large leakage or when the patient
has spontaneous breathing. Feature points provided by the P-V Tool function are for reference
only.

 In the P-V Tool interface, if no operation is performed within 3 min, the system will
automatically exit this interface.

1) Select [Tools] key → [P-V Tools] tab to enter the P-V Tool interface.
2) Select [Note] button to view the Note message of P-V tool in the opened interface.
3) Select [Measure] button and set the parameters of [Pstart], [Flow], [Pmax] and [Vlimit] in the
measurement interface. The system will use the equation to calculate the Tmax parameter value and
display it on the menu interface.
 Flow: The gas supply and expiratory flow of the static P-V loop.
 Pstart: The initial pressure of the static P-V loop.
 Pmax: The maximum pressure that the static P-V loop can reach.
 Vlimit: The maximum volume that the static P-V loop can reach.
 Tmax: The maximum measuring time needed to finish the static P-V loop measurement.
4) If [Start] button is selected, the system will perform the P-V tool measurement. If [Stop Breathing]
button is pressed during the measurement, the system will immediately terminate the inspiratory limb
measurement test, and start to conduct the inspiratory limb measurement. If [Abort Test] button is clicked
during the measurement, the system will immediately suspend measurement.
5) The system will enter the result analysis interface automatically after the measurement is finished. The
positions of [Cursor 1] and [Cursor 2] can be settled respectively as needed. When the [Cursor 1] button
or [cursor 2] button is pressed, the corresponding cursor will turn green. You can move the cursor by
rotating the main control knob to determine the feature points. The system also displays the volume and
pressure and compliance of the inspiratory limb and expiratory limb corresponding to the cursor position
respectively.

10-6
 Other functions

6) You can select [History] button and view the needed loop in the opened list. The system only displays the
loop you are viewing, whose measurement time is displayed on the right side of the [History] button.
7) You can select [Ref. Loop] button and view the needed loop in the opened list. The system only displays
the loop you are viewing, whose measurement time is displayed on the right side of the [Ref. Loop]
button.

10.11 Recruitment Tool (SI)

WARNING
 SI function is disabled in following situations:

 Sputum suction is in progress;

Note
 In SI process, pure oxygen or high oxygen concentration is used for ventilation;

 SI is not recommended for a patient with spontaneous breathing;

 It is recommended to stop SI when the patient's physiological state is abnormal.

Sustained Insufflation is a tragedy for lung protective ventilation. A pressure higher than the conventional
average airway pressure is provided and maintained for a specified period in the process of mechanical
ventilation. It can make collapsed alveolar reopen, and prevent secondary atelectasis caused by small tidal
ventilation.
SI function employs constant ventilation to fulfill a single cycle of lung recruitment.
1) Select [Tools] key → [SI] tab to enter the SI interface.
2) Select [Note] button to view the Note message of SI in the opened interface.
3) Select [Measure] button and set the parameters of [Pressure Hold] and [Hold Time] in the measurement
interface. The system will use the equation to calculate parameter values of Ppeak, Pmean and Peep, and
display them on the menu interface.
4) If [Start] button is selected, the system will perform the SI tool measurement if the [Stop] button is
clicked during measurement, the system will immediately stop measurement.

10.12 O2 Therapy

The ventilator can be used with a legally marketed oxygen mask or nasal congestion catheter to continuously
provide a certain concentration and flow rate of oxygen to the patient (commonly called as "oxygen
inhalation" or "oxygen therapy" in clinic).

10-7
 Other functions

Oxygen therapy, also known as supplemental oxygen, refer to the method of increasing the oxygen
concentration into the airway under a normal pressure through a simply connected pipeline. Oxygen therapy is
also a clinical measure to relieve or correct organic hypoxia condition through increasing the oxygen
concentration of the inhaled gas, raising inhaled alveolar oxygen concentration, promoting oxygen diffusion,
and thus adding the arterial PO2 (Partial pressure of blood oxygen) and SpO2 (blood oxygen saturation).
Oxygen therapy is a method for preventing or curing hypoxia. The oxygen concentration provided is higher
than that of air.

WARNING
 Oxygen therapy can only be used for patients with regular spontaneous breathing.

 The ventilator can only provide oxygen therapy to patients under the supervision of
professional medical staff. If there is a malfunction or the patient has difficulty in spontaneous
breathing, a professional medical worker can immediately give help.

 During oxygen therapy, only the FiO2 and oxygen flow rate are monitored.

 During oxygen therapy, all physiological alarms are shielded except the oxygen concentration
physiological alarm.

 Airway pressure and parameters related to ventilation, such as flow rate, minute ventilation,
asphyxia, were not monitored during oxygen therapy.

 For patients requiring increased oxygen concentration for treatment, SpO2 monitoring
equipment should be used to monitor SpO2. Otherwise, the deterioration of the patient's
condition may not be effectively recognized.

 Only oxygen mask or nasal congestion catheter can be used for oxygen therapy. Do not use NIV
masks for oxygen therapy. Improper use of masks can be dangerous to patients.

 Insufficient pressure of the gas supply may cause inaccurate control of oxygen concentration.

10.12.1 Enter Oxygen Therapy Interface

1) In the standby interface, select [O2 Therapy] button to enter the oxygen therapy interface.
2) Set [Flow] and [O2%] with proper values as needed.

10.12.2 Oxygen Therapy Timer/Timing

In the oxygen therapy interface, select [O2 Therapy Timer] button to enter the [O2 Therapy Timer] interface.
In the oxygen therapy timer interface, when the [Stop Timing] button is displayed, [Timer Reset] is locked
(with dark background) and disabled. Click [Stop Timing] button, and the button will change to [Start Timing].

10-8
 Other functions

Then [Timer Reset] is unlocked (with light background). The displayed timer will be reset as ZERO when this
button is clicked.
Click [Time] set icon beside [Oxygen Therapy Timer]. Rotate the main control knob clockwise or
counterclockwise to perform the oxygen therapy timing in the range of 0~600min. When the timer expires, the
system will sound a reminder, but the oxygen supply will be without interruption.

10.12.3 Turn Off Oxygen Therapy

Select [Standby] key during the oxygen therapy. Click [Standby] to enter the standby interface. Then the
oxygen therapy will be turned off.

10.13 Tube Resistance Compensation (TRC)

TRC stands for the automatic Tube Resistance Compensation. Select different size of endotracheal intubation
or tracheotomy tube for the patient. The ventilator can automatically adjust the gas supply pressure so that the
pressure at the tube end is consistent with the set pressure value on the ventilator as much as possible.
The TRC function can be set in the parameter settings interface of each mode.
1) Select ventilation mode and press [TRC] button to enter the automatic tube resistance compensation
interface.
2) Set Type of Intubation, Diameter, Compensation Ratio and Expiratory Phase Compensation in the
opened interface.

 [Tube Type]: endotracheal intubation and tracheotomy tube

 [Tube I.D.]: refer to the size of endotracheal intubation.

 [Compensate]: refer to the percentage of automatic tube compensation.

 [Expiration]: switch on/off the expiratory phase compensation function.

3) Select the [OK] button; the system will activate the TRC function automatically. When the TRC function
is activated automatically, if you enter the [TRC] interface and set [Tube Type] to [Disable TRC], the
system will immediately terminate the TRC function in the process of ventilation.
After turning ON the TRC function, the system will show the intratracheal pressure wave on the airway
pressure waveform. The waveform is not influenced by the [Draw Wave] settings. For more information of
plethysmography waveform, refer to "Section 5.1.1 Waveform Setting". See the figure below:

10-9
 Other functions

WARNING
 TRC can be triggered automatically. If it is triggered, check the patient, breathing circuit and
other possible causes.

CAUTION
 Incorrect tube type or tube diameter can result in patient injury. Please set the tube size
correctly.

10.14 IntelliSyn Smart Sync Technology

The ventilator provides IntelliSyn intelligent synchronization technology, which can adjust the exhalation
trigger through adaptive algorithm through the extraction and analysis of waveform characteristics.

10.15 Network settings

The network interface is only used by professional maintenance personnel authorized by Comen for software
upgrade and data transmission.

10-10
 Chapter 11 Battery

11.1 Overview

The device is equipped with a built-in rechargeable battery (This ventilator can be equipped with two built-in
rechargeable batteries). When AC power supply is connected, the battery can be charged automatically till full
no matter whether the device is turned on or not. When the battery is charging, the ventilator could operated
normally. In the event of unexpected power outage, the system will automatically use the battery to supply
voltage, thus to avoid interruption of device operation. After AC power supply is cut off, the battery indicator
light blinks, indicating the battery is being used to supply voltage, and device operation will not be affected.
The Battery icon shown on the screen indicates the current battery status:
:Connect outer power supply. The ventilator is powered by external power supply. The battery is being
charged.
:External power supply is not connected. The ventilator is powered by built-in power supply.
:External power supply is not connected. The ventilator is powered by built-in power supply. The battery
is too low. Charging is needed immediately.
:Battery is not installed or damaged.

Note
 If the battery is to be left unused for a long period of time, please remove the battery and keep
it properly.

 The device is provided with a built-in battery, the battery must be charged after each use to
ensure sufficient battery reserve.

WARNING
 If the battery needs replaced, it only can be performed by the specified maintenance personnel,
not by users. Improper replacement of the lithium battery will result in unacceptable risks.

 Battery electrolyte is hazardous. In case that battery electrolyte comes into contact with your
skin or enters your eyes, please wash with clean water immediately and seek medical advice.

 Please keep the battery out of the reach of children.

 When the battery is used for operation, the device will power off automatically when the
battery level is low.

 Only use this ventilator to charge the battery.

11-1
 Battery

 To prolong the battery life, the battery should be used at least every month, and charged when
the battery is to run out.

 Please check and replace the battery on a regular basis.

11.2 Optimize and Check Battery Performance

11.2.1 Optimize Battery Performance

The battery must undergo at least two complete optimization cycles before first use. The battery's performance
will gradually decrease as the time of use increases. It is recommended that you optimize the battery every six
months. If it is not optimized during a long time, the displayed battery voltage level may not be accurate.
When optimizing the battery, please ensure the following:
1) Completely disconnect the ventilator from the patient and stop all monitoring and measurement.
2) Put the battery for optimization in the battery case of the device.
3) Please ensure that the battery is charged uninterruptedly till it is fully charged.
4) Disconnect AC power supply, and use the battery to supply voltage to the ventilator till the ventilator
shuts down automatically.
5) Battery optimization is finished.

11.2.2 Check Battery Performance

The battery life varies with the storage and operation environments, frequency of battery discharging and use
time. The battery performance will degrade gradually even if the battery is not used.
A battery performance check must be performed every three months. When you suspect a battery fault, you
will also need to perform a battery performance check.
For the battery performance check procedure, see steps 1 to 4 in "Section 11.2.1 Optimize Battery
Performance". The length of discharge time reflects the performance of the battery. If the battery's power
supply time is significantly lower than the time stated in the Specifications, the battery should be replaced.

Note
 In order to prolong the service life of the rechargeable battery, if the battery is stored for a long
period of time, it is suggested that the battery should be charged every three months to prevent
excessive discharging.
 The voltage supply time of the battery depends on the configuration and operation of the
device.

11-2
 Battery

11.3 Store the Battery

Please ensure that the battery electrode is not in contact with any metal object when storing the battery. For
long-term storage, place the battery in a cool environment and maintain the battery capacity between 40% ~
60%.
Storage of the battery in a cool environment can postpone the aging process of the battery. Ideally, the battery
should be stored in a cool environment under the temperature of 15°C (60℉). Do not place the battery in an
environment beyond the temperature range of -20°C (-4℉) ~ 60°C (140℉).
If the ventilator is to be left unused for a long period of time, the battery should be removed; otherwise the
battery will discharge, thus significantly increasing the charging time. Maintain the battery capacity between
40% ~ 60%. Fully charge the battery before reuse.

Note
 Storage of the battery in an environment over 38℃ (100℉) will greatly reduce its expected service life.

11.4 Battery Recycling

If the battery is obviously damaged or runs out, it should be replaced. Waste batteries should be properly
recycled in accordance with applicable laws and regulations or the rules of the hospital.

WARNING
 Do not disassemble or short-circuit the battery or place it in fire; otherwise battery fire,
explosion, leakage of hazardous gas or other hazards may be caused.

 Disposing the device with the battery inserted presents a potential shock hazard.

11-3
 Chapter 12 Cleaning, Disinfection and Sterilization

Only materials and methods listed in this chapter that are accepted by the Company can be used for cleaning
or disinfection of the device. For any damage arising from use of unaccepted materials or methods, the
Company will not provide any warranty.
The Company will not assume any liability for the effectiveness of listed chemicals or methods when they are
used as infection control means. For infection control methods, please consult the Infection Prevention
Department or an epidemiologist in your hospital. Besides, please refer to local policies that apply to your
hospital and country.

12.1 Overview

This chapter describes the cleaning and disinfection methods of the ventilator, parts and accessories. The
cleaning and disinfection methods for other non-disposable accessories refer to the accessories’ accompanying
documents. The cleaning and disinfection or sterilization procedure, should refer to the instruction for use of
the individual accessories.
Please keep the device and its accessories dustless. After cleaning, please check the device carefully. If there
is any evidence of ageing or damage, please stop using it immediately. If it is necessary to send back the
device to Comen for repair, first clean it.

WARNING
 Please observe applicable safety protection regulations.

 Please carefully read the Material Safety Data Sheet of each detergent.

 Please carefully read all operation and maintenance instructions for the disinfection equipment.

 Only use detergents and disinfectants recommended in this Instruction Manual; use of other
detergents and disinfectants will result in damage to the device or safety risks.

 Before cleaning the device, please power it off and disconnect it from the AC power supply.

 It is not allowed to use detergent mixture; otherwise hazardous gases will be generated.

 This chapter only introduces the methods for cleaning reusable accessories. Disposable
accessories should not be reused after cleaning and disinfection to avoid cross infection.

 To protect the environment, disposable accessories must be recycled or dealt properly.

 Please wear safety gloves and goggles. Damage of the chemical oxygen sensor can cause leakage
and result in combustion (containing potassium hydroxide).

 If a reusable accessory or component is reused without disinfection, cross-infection can be

12-1
 Cleaning, Disinfection and Sterilization

caused.

 To prevent system leakage, take care to avoid part damage during removal and re-installation,
and ensure the installation correctness. During cleaning and disinfection, please ensure the
applicability of cleaning and disinfection methods to the parts and also ensure their correct use.

 Please carry out removal and assembly according to the instructions provided in this chapter.
For further removal and assembly, please contact our After-sales Service Department.

 Improper removal and assembly can result in system leakage, affecting normal use of the
equipment.

 Liquid ingress into the control component will damage the equipment or result in personal
injury. When cleaning the housing, please ensure that no liquid flows into the control
component, and always disconnect the equipment from AC power supply. AC power supply can
be reconnected only after the cleaned parts are completely dry.

 To prevent adhesion, do not use talc, zinc stearate, calcium carbonate, corn starch or similar
materials. These materials may enter the patient’s lung or airway, resulting in irritation or
injury.

 No modification of this equipment is allowed.

CAUTION
 If the device gets damped accidentally, put it in a ventilated place and then contact maintenance
personnel or our company immediately.

Note
 This equipment should be cleaned and disinfected as per need before initial use. The gas
pathways through the ventilator and its accessories that can become contaminated with body
fluids or by contaminants carried by expired gases during normal condition or single fault
condition, shall be subjected to cleaning and disinfection /sterilization. See this chapter for the
cleaning and disinfection methods.
 To prevent equipment damage, if there is any doubt about the detergent, please see the data
provided by the manufacturer.
 Do not use organic, halogenated or petroleum base solvents, glass cleaner, acetone or other
irritant detergents.
 Do not use abrasive detergents (e.g., steel wool, silver polish or cleaner).
 Any liquid should be placed away from electronic components.

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 Cleaning, Disinfection and Sterilization

 Never allow any liquid to flow into the housing.

 Only parts claimed for 134ºC allow sterilization with high-temperature steam.
 The pH value of cleaning solution must be between 7.0 ～ 10.5.
 After cleaning and disinfection, please perform system check before using this device again.
The device can be used after passing self- test.

12.2 Cleaning, Disinfection and Sterilization Methods

Parts of this ventilator can be cleaned and disinfected/Sterilization. The cleaning and disinfection methods
vary with different parts. Select appropriate methods to timely and correctly clean and disinfect each part
according to the actual situation, thus to prevent cross-infection of the ventilator user and the patient.

12.2.1 Cleaning, Disinfection and Sterilization of Main Unit and Patient’s Circuit

The table below lists the part cleaning and disinfection methods recommended by our company, including
those for initial use and reuse.

Part Recommended Cleaning Disinfection Sterilization

Time Interval
① ② A B C D
Wiping Soaking Wiping Soaking Ultraviolet
Pressure
(UV)
steam
radiation

Ventilator housing

External surface Each patient ① A or C

of ventilator
including housing,
power cord, gas
supply hose)

Trolley and Each patient ① A or C

supporting arm

Touch screen Each patient ① A or C

Fan Dust mesh Every 4 weeks ② B

/

As per need *

Dust mesh at the Every 4 weeks ② B

air inlet of main

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 Cleaning, Disinfection and Sterilization

unit /

As per need *

Inspiratory valve component of ventilator

Inhalation valve As per need * ② B or D

component

Expiratory valve component of ventilator

Expiratory valve
Each patient / ② B or D
diaphragm
Every week
(Silicone rubber)

Expiratory Valve
Each patient / ② B or D
Component
Every week
(diaphragm
excluded)

Patient circuit of ventilator (reusable)

Patient circuit
Each patient / Please refer to the cleaning and disinfection methods provided in the
(including water
Every week breathing circuit instructions.
trap, Y-pipe, and
adapting part)

Others

Each patient / Please refer to the cleaning and disinfection methods provided in the
Nebulizer
Every week Nebulizer instructions.

Cleaning Methods: Wipe and Bath Immersion

① Wiping: Use a wet cloth having been soaked in alkalescent detergent (e.g., soapsuds) or alcohol solution
to wipe the part, and use a dry lint-free cloth to wipe it dry.

② Soaking: Rinse with clear water; then soak in alkalescent detergent (e.g., soapsuds) solution (suggested
water temperature: 40ºC) for about 3 min; then wash with clear water and air-dry the part.

Disinfection Methods:

A. Wiping: Use a wet cloth having been soaked in intermediate or high-efficacy disinfectant (e.g., alcohol or
isopropanol) solution to wipe the part, and use a dry lint-free cloth to wipe it dry.

B. Soaking: Soak in intermediate or high-efficacy disinfectant (e.g., alcohol or isopropanol) solution

(recommended soaking time: >30 min); then wash with clear water and air-dry the part. (NOTE: The
inhalation valve component and expiratory Valve Component can only be disinfected by high-efficacy
disinfectant.)

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 Cleaning, Disinfection and Sterilization

C. UV: Disinfect the part through UV radiation; the recommended disinfection time is 30 ~ 60 min.

Sterilization Methods:

D. Pressure steam: Sterilize the part with high-temperature high-pressure steam (temperature: 134ºC); the
recommended sterilization time is 4 min. An autoclave can be used to increase the steam pressure, and its
temperature will also rise to rapidly solidify bacterial protein.

As per need*: If the equipment is used in a dusty environment, please reduce the cleaning and disinfection
interval according to the circumstances, thus to ensure that the appearance is free from dust blockage. The
inspiratory valve component needs cleaning and disinfection only when the gas exhaled by the patient may
contaminate the inspiratory limb. For the removal and installation methods, see “Section 12.3.2 Inspiratory
Valve Component and Diaphragm”.
The table below lists the detergents, disinfectants and high-efficacy disinfection methods that can be used for
the ventilator.

Name Type

Alcohol (75%) Intermediate-efficacy disinfectant

Isopropanol (70%) Intermediate-efficacy disinfectant

Glutaraldehyde (2%) High-efficacy disinfectant

o-Phthalaldehyde disinfectant (e.g., Cidex®OPA) High-efficacy disinfectant

Soapsuds (pH value: 7.0 ~ 10.5) Detergent

Clear water Detergent

Sterilization with high-temperature high-pressure Sterilization

steam*

Remark: Sterilization with high-temperature high-pressure steam*: The recommended temperature for this method is 134ºC
(273ºF).

Note
 For reusable breath tubing, do follow the cleaning and sterilization method marked on its user
manual and package label. The expected number of procedure cycles during expected service
life is 30 times.

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 Cleaning, Disinfection and Sterilization

12.2.2 Cleaning and Disinfection of Physiological Module Accessories

Part Recommended Cleaning Disinfection

Time Interval
① Wiping ② Soaking A: Wiping B: Soaking

Physiological Module

CO2 extended cable, CO2 sensor, Each patient / ① A

CO2 analyzer Every week

Respironics/Comen CO2 Each patient / ① A

sampling line inlet Every week

SpO2 sensor and cable Each patient / ① A

Every week

Cleaning Methods (Wipe and Bath Immersion):

① Wiping: Use a wet cloth having been soaked in detergent solution to wipe the part, and use a dry lint-free
cloth to wipe it dry.

② Soaking: Rinse with clear water; then soak in detergent solution (suggested water temperature: 40º
C) for
about 3 min; then wash with clear water and air-dry the part.

Disinfection Methods

A. Wiping: Use a wet cloth having been soaked in disinfectant (e.g., alcohol or isopropanol) solution to wipe
the part, and use a dry lint-free cloth to wipe it dry.

B. Soaking: Soak in disinfectant (e.g., alcohol or isopropanol) solution (recommended soaking time: >30
min); then wash with clear water and air-dry the part.

Parts for Disinfection Detergent Disinfectant

CO2 extended cable Clean water, 75% alcohol OPA (5.5g/l), 75% alcohol, 70% isopropanol,
70% n-propanol, 2% glutaraldehyde, 3%
hydrogen peroxide, 0.5% sodium hypochlorite
solution

Masimo mainstream CO2 Clean water, 75% alcohol 75% alcohol, 70% isopropanol
analyzer component

Respironics/Comen CO2 Clean water,75% alcohol 75% alcohol, 3% hydrogen peroxide, 0.6% or 2%
sampling line inlet sodium hypochlorite solution

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 Cleaning, Disinfection and Sterilization

Respironics/Comen Clean water, mild soap 70% isopropanol

mainstream CO2 analyzer liquid
component

Respironics/Comen Clean water, 75% alcohol OPA (5.5g/l), 70% isopropanol, 70% n-propanol,
Sidestream CO2 analyzer 2% glutaraldehyde, 3% hydrogen peroxide, 0.5%
component sodium hypochlorite solution

Masimo and Nellcor SpO2 Water, neutral detergent, 0.5% sodium hypochlorite solution
sensor and cable 70% isopropanol

Comen SpO2 sensor and Clear water, 75% alcohol OPA (5.5g/l), 70% isopropanol, 70% n-propanol,
cable 2% glutaraldehyde, 3% hydrogen peroxide, 0.5%
sodium hypochlorite solution

SpO2 sensor extended Clear water, 75% alcohol OPA (5.5g/l), 70% isopropanol, 70% n-propanol,
cable 2% glutaraldehyde, 3% hydrogen peroxide, 0.5%
sodium hypochlorite solution

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 Cleaning, Disinfection and Sterilization

12.3 Disassemble the Ventilator’s Cleanable and Disinfectable Parts

12.3.1 Expiratory Valve Component and Diaphragm

(3)

(1)
(2)

(4)
(5)

(1) Expiratory valve component (2) Expiratory valve handwheel (3) Expiratory valve diaphragm
(4) Expiratory valve locked status (5) Expiratory valve unlocked status
 Removal Method

1) Rotate the expiratory valve handwheel counterclockwise until the indicating arrow “ ”on the wheel is in

line with ; then pull out the expiratory valve component laterally.
2) Remove the expiratory valve diaphragm.
 Installation Method
1) Install the expiratory valve diaphragm onto the expiratory valve component.
2) Push the expiratory valve component into the corresponding port on the ventilator to the end. Ensure that

the indicating arrow “ ” on the handwheel is in line with , and then rotate the wheel clockwise

(while pressing the hand wheel in its installing direction) until the indicating arrow “ ” on the hand

wheel is in line with .

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 Cleaning, Disinfection and Sterilization

12.3.2 Inspiratory Valve Component and Diaphragm

12.3.2.1 Inspiratory Valve Component

(1)
(2)
(3)

(4)
(5)

(1) Seal ring (2) Safety valve component (3) Safety valve handwheel
(4) Safety valve locked status (5) Safety valve unlocked status
 Removal Method

Rotate the safety valve hand wheel counterclockwise until the indicating arrow “ ” on the wheel is in line

with ; then pull out the safety valve component laterally. Check if the seal ring on the end of safety valve
comes adrift, and put it back if so.
 Installation Method
Push the safety valve component into the corresponding port on the ventilator to the end. Ensure that the

indicating arrow “ ”on the handwheel is in line with , and then rotate the wheel clockwise (while pressing

the handwheel in its installing direction) until the indicating arrow “ ” on the handwheel is in line with .

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 Cleaning, Disinfection and Sterilization

12.3.2.2 Inspiratory safety valve diaphragm

(1)

(2)
(3)

(4)

(5)

(1). The detachable body of the suction valve (2). The safety valve diaphragm gasket

(3). Safety valve diaphragm (4). Safety valve port (5). Suction valve body

 Removal Method
1) Face the safety valve port; turn the safety valve port counterclockwise. When the safety valve port boss
reaches the groove of the suction valve body, pull out the safety valve port.
2) Remove the Safety valve diaphragm.
 Installation Method
1) Assemble the safety valve diaphragm to the main body of the suction valve. The shaft of the safety valve
diaphragm gasket matches the hole on the main body of the suction valve. Confirm that the safety valve
diaphragm is completely assembled on the safety valve diaphragm gasket.
2) After aligning the valve port of the safety valve with the groove of the main body of the suction valve,
insert it into the valve port of the safety valve, press it tightly and rotate it clockwise to the right limit
position.

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 Cleaning, Disinfection and Sterilization

12.3.3 High-efficiency Particulate Air (HEPA) and Dust Mesh

(1)

(2)

(3)

(1) HEPA high-efficiency filter (2) Main unit air inlet baffle (3) Air inlet dust mesh
 Removal Method
1) Grasp the two fasteners on the main unit air inlet baffle to remove the baffle.
2) Grasp the fastener on the HEPA high-efficiency filter to remove the filter. If the air inlet dust mesh needs
disassembled, just hold it with two fingers and take it out.
 Installation Method
1) Push the HEPA high-efficiency filter in along the corresponding grooves; press it in the installing
direction; then lock the fastener on it.
2) Check the fastener position on the HEPA high-efficiency filter and ensure that it is locked well.
3) Install the main unit air inlet baffle.

CAUTION
 Do not operate the ventilator if a high-efficiency air filter (HEPA) is not installed. Otherwise the
inspiratory side of the device and the patient circuit will be polluted.

Note
 Ensure the HEPA filter and air inlet air mesh installed conform with specification
requirements.

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 Cleaning, Disinfection and Sterilization

12.3.4 Fan dust Mesh

(1)

(2)

(1) Fan Dust mesh (2) Main unit air inlet baffle
 Removal Method:
1) Grasp the two fasteners on the main unit air inlet baffle to remove the baffle.
2) Remove the dust mesh.
 Installation Method:
1) Place the dust mesh on the corresponding position against the cooling fan.
2) Move the main unit air inlet baffle until the two convex points on it drop into the corresponding groove
on the main unit; lock the fastener on the baffle in place.

12.3.5 Breathing tube

WARNING
 To minimize the risk of bacterial contamination or physical damage, please carefully remove and install the
bacterial filter.

CAUTION
 When removing a reusable patient circuit, do not pull the circuit. Please screw off the circuit from the connector
position of the ventilator.

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 Cleaning, Disinfection and Sterilization

(3)
(4)
(5)

(2)
(1)

(1) Inspiratory water trap (2) Expiratory water trap (3) Pipe hook
(4) Inspiratory filter (5) Expiratory filter
 Removal Method:
Simply disconnect each breathing tube.
 Installation Method:
1) Install the filters at the inspiratory and Expiratory connectors respectively.
2) Connect the inspiratory filter to the water trap via the tube, and connect the other end of the tube to the
Y-pipe.
3) Connect the expiratory filter to the water trap via the tube, and connect the other end of the tube to the
Y-pipe.
4) Use the patient end of the Y-connector to connect the patient.
5) Put the breathing tube on the supporting arm hook as the last step.

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 Cleaning, Disinfection and Sterilization

12.3.6 Nebulizer

(3)
(1)

(2)

(1).Nebulizer connector (2).Nebulizer intake pipe (3).Nebulizer

 Removal Method:
1) Disconnect the Nebulizer intake pipe from its corresponding port.
2) Disconnect the pipes connected with the Nebulizer to take out the atomizer.
 Installation Method:
1) Install one end of the Nebulizer intake pipe to the Nebulizer connector, and the other end to the
Nebulizer.
2) Install the Nebulizer on the inspiratory limb of the breathing tube via the tube.

Note
 Please install a Nebulizer conforming to the specification requirements. The Nebulizer
components and installation and removal methods described in this section are for reference
only.

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 Cleaning, Disinfection and Sterilization

12.3.7 Humidifier

Note
 The humidifier should conform to the requirements of ISO 80601-2-74. The humidifier
components and removal and installation methods described in this section are for reference
only.

12.3.7.1 Removal of Humidifier on the Ventilator

(3) (4)

(2)
(1) (5)
(6)

(1).Screw (2).Humidifier (3).The humidifier outlet

(4).The humidifier inlet (5).Retaining bracket of humidifier holder (6). Humidifier pulley

 Removal Method
1) Disconnect the pipe connected with the humidifier.
2) Unscrew the screw.
3) Carry the humidifier upward to move it out of the retaining bracket of humidifier holder.
 Installation Method
1) Align the humidifier pulley with the humidifier frame fixing seat and slide it in.

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 Cleaning, Disinfection and Sterilization

2) Tighten the screw.

3) Install the filters at the inspiratory and expiratory connectors respectively.
4) Connect the inspiratory filter to the humidifier inlet via the tube.
5) Connect the humidifier outlet with the water trap via the tube; then connect the water trap with the Y-pipe
via the tube.
6) Connect the expiratory limb filter with the water trap via the tube; then connect the water trap with the
Y-pipe via the tube.
7) Put the breathing tube on the pipe hook of the supporting arm.

12.3.7.2 Removal of Humidifier on the Tower

(1)
(2)
(3)
(4)
(7)
(5)

(6)
(1).Humidifier (2).Fixing block knob (3).Fixing block
(4).Humidifier pulley (5).Retaining bracket of humidifier holder (6).Screw
(7).Flat-tube beam

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 Cleaning, Disinfection and Sterilization

 Removal Method
1) Disconnect the pipe connected with the humidifier.
2) Unscrew the screw.
3) Carry the humidifier upward to move it out of the retaining bracket of humidifier holder.
 Installation Method
1) Loosen the fixing block knob; place the fixing block on the flat-tube beam on the tower.
2) Tighten the fixing block knob.
3) Align the humidifier pulley with the humidifier frame fixing seat and slide it in.
4) Tighten the screw.
5) Install the pipe for more connection details refer to Step 3 to Step 7 in Installation Method of Section
12.3.7.1.

12.3.8 Mainstream CO2 Sensor

(2)
(1)

(3)
(4)

(1) Elbow tube (2) Y-shaped tube (3) Airway adapter (4) Breathing tube port

 Removal Method
Pull out the CO2 sensor in the vertically upward direction.
 Installation Method
Install the CO2 sensor onto the CO2 adapter in a vertically downward direction.

12-17
 Chapter 13 Maintenance

13.1 Service Principles

All necessary service work should be done by service representatives authorized by our company whenever
possible; replacement and maintenance of parts listed in this manual can also be done by qualified
professionals.
Upon request by the user, Comen will conditionally provide relevant circuit diagrams to help the user to repair
user-serviceable components of the device by appropriate and qualified technicians.

WARNING
 It is possible that used equipment is contaminated by blood or body fluid. Please observe the
disinfection control and safety rules.

 Moving parts and removable parts have the risk of pinching hands or being crushed; be alert when
moving or replacing system parts.

 Do not use lubricants containing oil or grease because such lubricants have the risk of combustion
or explosion when certain O2 concentration is reached.

 Service work should not be done by persons without experience in servicing this type of equipment.
 Damaged parts should be replaced by parts manufactured or sold by our company. Test should be
performed after replacement to ensure that the equipment conforms to the manufacturer’s
specification requirements.
 When the ventilator is in normal use, please do not repair or maintain.

Note
 For service support, please contact our After-sales Service Department.

13.2 Maintenance Schedule

Time Interval Part/Accessory Maintenance

Each patient or Breathing tube (including Carry out zero calibration of pressure and flow.
as per need mask, inspiratory filter,
Carry out system function check.
flow sensor, expiratory
valve and diaphragm) Carry out flow sensor calibration. (Refer to "Section 13.5
Flow Calibration".)

Replace parts with disinfected or new disposable parts.

As per need Inspiratory valve When it is possible that the inspiratory valve component

13-1
 Maintenance

component is contaminated by the gas exhaled by the patient, it is

necessary to replace the inspiratory safety valve and
diaphragm with a disinfected one. (Refer to "Section
12.3.2 Inspiratory Valve Component and Diaphragm".)

Expiratory valve Replace the expiratory valve component if it is damaged.

(Refer to "Section 12.3.1 Expiratory Valve Component
and Diaphragm")

CO2 calibration In case of large deviation of the measured value of CO2,

please calibrate the CO2 module.

Several time a Breathing tube (single Check the water accumulation condition in the breathing
day or as per patient use or reusable) tube and the water trap, and empty them promptly.
need
Check each part for damage; replace them where
necessary.

During Ventilator Check each part for damage; replace them where
cleaning or necessary.
installation

Every day or Ventilator Clean the external surface.

as per need
O2 sensor Calibrate the O2 sensor.

Before each Whole machine Perform system check; check the respiratory system for
use or after resistance and leakage.
two weeks of
continuous use

Every year or Dust mesh at air inlet and Check dusts accumulated on the dust mesh, clean or
as per need the fan replace it if needed (refer to "Section 12.3.4 Fan Dust
Mesh")
Dust mesh

Check every Lithium battery Check the charge and discharge condition of the lithium
six months, battery every six months. Replace the lithium battery
and replace every two years. Please contact our After-Sales Service
every two Department for replacement.
years

Every year or O2 sensor Replace the O2 sensor if it is damaged.

every 5000 h,
(refer to "Section 3.10 Install the Oxygen Sensor").
or as per need
[Note] The service life of the O2 sensor is roughly
estimated. The actual life depends on the working

13-2
 Maintenance

environment. Exposure to high temperature or high

oxygen concentration will reduce its service life.

Air inlet HEPA filter Replace it (refer to "Section 12.3.3 High-efficiency

Particulate Air (HEPA) and Dust Mesh").

Ventilator Please contact our After-Sales Service Department for

preventive maintenance.

Check valve Examine check valves of air source, spontaneous

inspiration and expiratory limb.

Where necessary, please contact our After-Sales Service

Department for replacement.

Backup Alarm System Check the alarm duration of the backup alarm system
(buzzer) If it is too short, Contact our After-sales Service
Department.

Gas supply seal ring Check the gas supply seal ring. Where necessary, please
contact our After-Sales Service Department for
replacement.

Expiratory valve Check the expiratory valve diaphragm. Where necessary,

diaphragm please contact our After-Sales Service Department for
replacement.

Every six years Battery of clock module Replace the battery of the clock module. Contact our
or as per need After-Sales Service Department.

Every 20,000 Blower box Please contact our After-Sales Service Department for
hours replacement.

At least once Mainstream and sidestream Please contact our After-Sales Service Department.
every two CO2 calibration and
years or when performance check
measurement
out of accuracy
range

Note
 When the turbine reaches the end of its service life, the ventilator prompts [Blower Needs
Maintenance] in the prompt information area.

13-3
 Maintenance

13.3 Zero Calibration of Pressure and Flow

Zeroing should by calibrated in case of large error in the monitored pressure/flow value. It can be performed
whether in standby condition or during ventilation.
1) Select [Setup] key → [Calibration].
2) Select [Zero] key → [Start] key. Pressure/flow zeroing will be activated, and the system displays a
prompt: [Sensor Zeroing].
3) If [Stop Zeroing] button is pressed, the process of zero calibration will be terminated. The system will
display a prompt [Zeroing stops!] simultaneously. If [Re-zero] is pressed, the zero calibration will be
restarted.
4) If the zero calibration is passed, the system will display a prompt: [Sensor Zeroing Completed].
Otherwise [Zeroing Failed!] will be prompted. In this condition a re-zero calibration is needed.

13.4 Flow Calibration

Note
 Do not perform the flow calibration when the system is connected to a patient.
 Do not perform the flow calibration When O2 source type is low-pressure O2.
 Do not operate any pneumatic circuit components of the device during the calibration,
particularly moving or squeezing breathing tube.
 Ensure the system is in standby condition. Otherwise select [Standby] key and confirm it to
enter the standby interface.
 It is recommended to disconnect the ventilator from the humidifier before calibration.
Calibrate the flow sensor in case of large error in the sensor monitoring value or after replacement.
Perform the flow calibration as follows:
1) Connect a high-pressure O2 source;
2) Connect the breathing tube and insert the Y-shaped connector into the leak detection plug, in order to
close the breathing circuit.
3) Select [Setup] key → [Calibration] → [Flow], then select [Start] button. Flow zeroing will be activated,
and the system displays a prompt: [Calibrating...].
4) If [Stop] button is pressed, the process of calibration will be terminated. The system will display a
prompt [Calibration stopped!] simultaneously. If [Re-calibrate] is pressed, the calibration will be
restarted.
5) If the calibration is passed, the system will display a prompt: [Calibration succeeded!]. Otherwise
[Calibration Failed!] will be prompted. In this condition a re-calibration is needed.

Note
 If the calibration is failed, check whether the corresponding alarm is generated; if it is still
failed after removing the alarm, or if the measurement error after calibration is bigger than

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 Maintenance

normal, replace the flow sensor; if the measurement error is still not be improved, contact the
authorized after-sales service personnel in time.

13.5 O2 concentration calibration

Calibrate the oxygen concentration in case of (1) large error in monitoring value of O2 concentration, (2)
replacement of O2 sensor.
Perform the O2 concentration calibration as follows:
1) Connect a high-pressure O2 source;
2) Select [Setup] key → [Calibration] → [O2%]; then select [Start] button. The O2 concentration calibration
will be activated, and the system displays a prompt: [Calibrating...].
3) If [Stop] button is pressed, the process of calibration will be terminated. The system will display a
prompt [Calibration stopped!] simultaneously. If [Re-calibrate] is pressed, the calibration will be
restarted.
4) If the calibration is passed, the system will display a prompt: [Calibration Succeeded!]. Otherwise
[Calibration Failed!] will be. In this condition a re-calibration is needed.

Note
 If the O2 calibration fails, please observe whether there is any technical failure alarm. If yes,
eliminate the failure and perform an O2 calibration again. If the repeated calibrations fail,
replace the O2 sensor and perform an O2 calibration again. If the calibration still fails, contact
the maintenance personnel or our company for help.
 The waste O2 sensor should not be burnt but disposed of according to the applicable
regulations on biological hazards.
 O2 concentration monitoring has no function of atmospheric pressure compensation. If the
ambient atmospheric pressure changes, a new O2 concentration calibration should be
performed.
 Since it is oxygen partial pressure that the O2 sensor measures, it is affected by the pressure
(absolute pressure) fluctuation. A 10% increase in pressure (absolute pressure) will cause a
10% increase in O2 concentration; a 10% decrease in pressure (absolute pressure) will cause a
10% decrease in O2 concentration. If the ambient atmospheric pressure changes, a new O2
concentration calibration should be performed.

13-5
 Maintenance

13.6 Handle Water Accumulation Problem in Flow Sensor

13.6.1 Prevent Water Accumulation

Gas exhaled by the patient is warm and moist, and becomes condensed during flow along the expiratory pipe.
The residual condensate water will be left on the pipe wall and finally flow into the water trap. When the
exhaled gas arrives at the expiratory valve, condensate water can be produced at the expiratory valve
(including expiratory flow sensor), affecting measurement of the expiratory flow sensor.
If it is found that the flow waveform is abnormal and the tidal volume fluctuation is unstable, please check
whether there is accumulated water inside the expiratory valve. If accumulated water exists in the expiratory
valve, please clear the accumulated water before reuse.
During use of the ventilator, please observe the water trap in the expiratory pipe on a regular basis. If there is
plenty of accumulated water, please clear it in time. Use of a bacterial filter between the expiratory pipe and
the expiratory valve can relieve the water accumulation problem in the expiratory valve.

13.6.2 Clear Accumulated Water

When there is accumulated water in the expiratory valve, remove the expiratory valve and clear accumulated
water inside it; then reinstall the expiratory valve for reuse.

Note
 Every time after cleaning and disinfection of the respiratory system, please ensure that all parts of the
respiratory system are kept dry.

 If it is found that the flow waveform is abnormal and the tidal volume fluctuation is unstable, please check
whether there is accumulated water inside the expiratory valve; clear the accumulated water if any.

13.7 Electrical Safety Test

Note
 Check the electrical safety after servicing or routine maintenance. Before electrical safety check and test, all
covers, panels and screws should be correctly installed.

 It is suggested to perform an electrical safety test every year.

1) Perform the Protective Earth Resistance Test

a） Connect the two earth resistance testing probes of the safety analyzer respectively to the screw and
the protective earth terminal of AC power cord.
b） Test the earth resistance using 25 A testing current.
c） Verify that the resistance value does not exceed 0.1ohms (100mohms).

13-6
 Maintenance

d） If the resistance value exceeds 0.1ohms (100mohms) but is less than 0.2ohms (200mohms), remove
the AC power cord, and connect the probe that is previously connected to the protective earth
terminal of AC power cord to the protective earth terminal of power outlet, and repeat Steps a to c.
2) Perform the earth leakage current test under the following conditions:
 Normal Polarity
 Reverse Polarity
 Open Neutral, Normal Polarity
 Open Neutral, Reverse Polarity
3) Verify that the maximum leakage current does not exceed 500μA (0.5 mA) under the first two conditions,
and does not exceed 1000 μA (1 mA) under the last two conditions.

Note
 Please use a certified safety analyzer (e.g., UL, CSA or AMAI), and perform tests according to the operation
instructions.

13-7
 Appendix I Operating Principle

I.1)Pneumatic circuit Diagram

I.2)Part List
Symbol Name Symbol Name
Low AIR Low-pressure air source F5 Filter screen
F1 Dust filter screen SOL0 Three-way valve
F2 HEPA filter Blower P Blower pressure sensor
Pfilter Negative pressure sensor Insp. valve Inspiratory valve
Low O2 Low-pressure O2 source OS O2 concentration sensor
CV1 Check valve F6 Filter screen
High O2 High-pressure O2 source Q2 Flow sensor
F3 Filter CV2 Check valve
REG Pressure regulating valve CV3 Check valve
PSOL Proportional solenoid valve SV Safety valve
F4 Filter screen CV2 Check valve
Q1 Flow sensor SOL4 Three-way valve
Mixing Box Class-I mixing noise-cancellation Insp.P Inspiratory pressure sensor
cavity
Blower Blower CV4 Check valve
Q3 Expiratory flow sensor SOL2 Three-way valve
Exp.Val Expiratory valve SOL3 Three-way valve
NCV Atomizing valve Pflow Expiratory differential pressure
sensor
R1 Nebulizing air resistance Exp.P Expiratory pressure sensor
R2 Air resistance F6 Filter

I-1
 Operating Principle

I.3) Principle description

This product is an electronically driven and electronically controlled ventilator. Oxygen is provided by high-
or low-pressure oxygen port. Air is inhaled from the ambient atmosphere due to vacuum produced by the
turbine motor. During the inspiratory phase, the inspiration valve opens. Gas with specific O2 concentration is
formed in the upstream of inspiration valve after Air and O2 are mixed. Such gas becomes gas with specific
flow or pressure after passing through the inspiration valve and enters the patient’s lungs via inspiratory tube.
During the expiratory phase, the inspiration valve is closed while the expiration valve opens. The gas reaches
the expiration valve from the lungs via the expiratory tube and is finally discharged out of the human body.
When the turbine works to inhale Air from the ambient atmosphere, Filter (F1) filters dust in the Air. Filter
(F2) is an HEPA filter for filtering bacteria. After the machine is used or placed for a period of time, dust or
foreign substance absorbed on the surfaces of the two filters at the Air inlet can occlude the Air inlet when the
dust or foreign substance is accumulated to a certain extent. This may cause insufficient Air intake of the
machine and compromise the ventilation performance of the machine. Vacuum sensor (Pfilter) at the Air inlet
monitors the vacuum at the Air inlet in real-time, effectively judges filter occlusion at the Air inlet, and gives
the replacement prompt.
Check valve (CV1) ensures unidirectional flow of low-pressure O2. Filter (F3) filters foreign substance in the
high-pressure O2 supply. Regulator (REG) regulates and stabilizes the pressure of high-pressure O2 supply to
ensure the stability and repetitiveness of flow outputted by the rear proportional solenoid valve (PSOL).
Filter screen (F4) is placed before the flow sensor to stabilize gas flow for the convenience of sensor
measurement. Flow sensor (Q1) is a hot-wire mass flow sensor which does not require calibration.
The gas supply part includes three parallel limbs: high-pressure O2, low-pressure O2, and low-pressure Air.
The high-pressure O2 and low-pressure O2 converge before mixing with Air. High-pressure O2 and
low-pressure O2 cannot be used at the same time. Flow sensor (Q1) is placed at the common outlet of
low-pressure O2 and high-pressure O2 to monitor O2. Room air enters the machine after passing through filter
(F1) and HEPA filter (F2).
Turbine blower (Blower) inhales the room air and externally connected O2 and outputs them to the rear end of
the inspiratory limb after compression. The turbine blower module contains two levels of labyrinth, which are
located in the upstream and downstream of the turbine blower respectively. Air and O2 are inhaled by the
turbine blower after going through the first level of labyrinth chamber (SD1). The mixed gas of Air and O2 is
then compressed by the turbine blower and enters the second level of labyrinth chamber (SD2). These two
levels of labyrinth chamber mix Air and O2 and reduce noise. The turbine blower motor has a thermal
conductive metal piece which conducts heat for heat dissipation via a cooling fan.
The large-diameter inspiration valve (Insp. valve) controls inspiratory pressure or flow. This valve uses voice
coil motor as the driving component. In case of power failure, the valve port is automatically sealed via spring
preload. When the voice coil motor takes actions, the valve port opens. Different output flows or pressures are
acquired by exerting different control currents to the voice coil motor.

I-2
 Operating Principle

The outlet of large-diameter inspiration valve is connected to flow sensor (Q2) which monitors the flow in the
inspiratory limb. Flow sensor (Q2) is a hot-wire mass flow sensor which does not require calibration. O2
sensor (OS) monitors O2 volume percentage concentration in the inspiratory limb.
Check valve (CV2) prevents patient’s expired gas from polluting the components in the upstream of this valve
under the single fault condition of expiratory limb being occluded.
Safety valve (SV) ensures that the pressure in the inspiratory limb is kept within the safe range and provides
flow to the spontaneous inspiratory channel when the system is powered down. It is controlled by
electromagnet. When the ventilator is in normal working state, the electromagnet is powered on and the safety
valve is in closed state. When the pressure in the inspiratory limb exceeds the system setting pressure, the
electromagnet is powered down and the safety valve is opened to release excess pressure. When the system is
powered down, the electromagnet is in power-down state and the safety valve is opened by default. The
patient inhales the external gas through the spontaneous inspiratory channel.
The expiration valve assembly integrates the expiration valve (EV) and flow sensor (Q3). Q3 is a diaphragm
differential pressure flow sensor. It monitors the front and rear pressure and Flow Calibration processes for
calibration via the differential pressure sensor PQ3. PE is an expiratory pressure sensor which monitors the
airway pressure. F9, F10 and F11 are filters which protect the upstream components from being polluted by
the patient’s expired gas. R2 and R3 are resistors which flush weak flow introduced to the expiration valve
from the gas supply, preventing water vapour condensation from occluding the pressure measurement tubes.
CV3 is a check valve which prevents gas from flowing in the reverse direction.
F7 and F8 are bacteria filters. They are connected to the inspiration port and patient port when they are used
by the ventilator. The nebulizer is pneumatic. The drive gas is introduced into the nebulizer via the nebulizer
connector on the front panel; and the liquid medicine is nebulized, enters the inspiratory tube, and reaches the
patient’s lungs. The pneumatic nebulizer can be connected only when the machine is connected with
high-pressure O2.

I-3
 Appendix II Accessories

Warning

 In order to avoid damage to the instrument and ensure the safety of the patient, please use
accessories specified in this manual or conforming to relevant standards.

 Disposable accessories are for single use only; reuse of such accessories may result in
performance degradation or cross-infection.

 If an accessory or its package shows any evidence of damage, please do not use this accessory.

 All accessories that can come in contact with human body must comply with the requirements
of ISO10993-1 on biocompatibility; no adverse reactions can be caused when such accessories
contact human body.

 For other accessories necessary for realizing the functions of this equipment, please choose
legal products on the market.

 This ventilator and its supporting accessories have been tested for compliance with relevant
standards.
 Before monitoring the patient, check the accessories are compatible with the ventilator.
Incompatible accessories reduce the performance of the ventilator.

 The accessories provided in this manual are used in conjunction with this ventilator.
 Do not add any attachments or accessories to the ventilator that contravene the instructions for
use of the ventilator or accessory, as the ventilator might not function correctly, leading to the
risk of patient death or serious deterioration of health.

1) SpO2 accessories
Specifications Models Part of body applied Intended patient Remarks
population
Comen SpO2 cable extender SLZ122 / / Reusable
Comen SpO2 probe (Adult Finger Adult Reusable
SAL104
use, finger clip type)
Comen SpO2 probe (Adult Finger Adult Reusable
SAS104
use, finger clip type)
Comen SpO2 probe Foot /Toe/Finger Pediatric Reusable
SES104
(Pediatric use, bandage type)
Comen SpO2 probe (Adult Finger Adult Reusable
A0816-SA105PV
use, finger clip type)
Masimo SpO2 M-LNCS / / Reusable
S-A1202026
series patient cable extender
Masimo SpO2 probe (Adult M-LNCS DCI Toe/Finger Adult/ Pediatric Reusable

II-1
 Accessories

use, finger clip type) (>30 kg)

Masimo SpO2 probe (Adult, Foot /Toe/Finger Adult/ Pediatric or Reusable
pediatric and infant use, Y- M-LNCS YI neonatal (>1 kg)
type)
Masimo SpO2 Y-shaped / / /
049-000256
sheath
Masimo SpO2 RD-SET / / Reusable
CM12-RD-L
series patient cable extender
Adult Reusable finger clip Toe/Finger Adult/ Pediatric Reusable
RD SET DCI
SpO2 sensor (>30 kg)
Padiatric/Slender digit Toe/Finger Adult/ Pediatric Reusable
Reusable finger clip SpO2 RD SET DCI-P (10-50kg)
sensor
Masimo SpO2 probe (Adult Foot /Toe/Finger Adult/ Pediatric or Reusable
use, pediatric and infant use, RD SET YI neonatal (>1 kg)
Y- type)
Neonatal/Adult pulse Foot /Toe/Finger Adult (>40 kg) or Single
RD SET Neo CS-2
oximeter Adhesive sensor neonatal (<3 kg) patient use
Neonatal/Adult pulse Foot /Toe/Finger Adult （>40 kg) or Single
RD SET Neo
oximeter Adhesive sensor neonatal (<3 kg) patient use
Nellcor SpO2 cable extender SLZ068 / / Reusable
Nellcor SpO2 probe (Adult Finger Adult/ Pediatric Reusable
DS100A
use, finger clip type) (>40kg)
Nellcor SpO2 probe (Adult Foot /Toe/Finger Adult/ Pediatric Reusable
D-YS
use, Y- type)

2) CO2 accessories
Specifications Models Remarks
Masimo mainstream CO2 module CAT.NO.200101 Reusable
Masimo mainstream CO2 adaptor CAT.NO.106220 Single patient use
Masimo CO2 module interface cable 98ME07GC968 Reusable
Masimo sidestream CO2 sampling line with male connector Single patient use
CAT.NO.108210
(adult, padiatric and infant use)
CO2 sampling tube with airway adaptor set for Adult REF 3827 Single patient use
CO2 sampling tube with airway adaptor set for Adult /Pediatric REF 3828 Single patient use
Respironics mainstream CO2 module 1015928 Reusable
Respironics mainstream CO2 airway adaptor 6063-00 Single patient use
Respironics CO2 module interface cable 98ME07GC067 Reusable
Respironics CapnoTrak sidestream CO2 module F-01 Reusable
Respironics sidestream CO2 filtering tube 1103416 Single patient use
Respironics sidestream CO2 dehumidification tube 1103417 Single patient use
Respironics sidestream CO2 airway adapter set for Adult use 1103414 Single patient use
Respironics sidestream CO2 airway adapter for Pediatric use 1103415 Single patient use
COMEN sidestream CO2 module F-02 Reusable
COMEN mainstream CO2 module M-01 Reusable

II-2
 Accessories

3) Breathing circuit accessories

Specifications Models Remarks
VADI Reusable adult breathing tube (with and without heated wire) G-328000 /
VADI Disposable adult breathing tube G-316002 /
VADI Disposable adult breathing tube with heated wire G-316003 /
VADI Reusable paediatric breathing tube (with and without heated G-330000 /
wire)
VADI Disposable paediatric breathing tube G-316002-01 /
VADI Disposable paedistric breathing tube with heated wire G-316003-01 /
VADI Reusable infant breathing tube (with heated wire) G-329000 /
VADI Disposable infant breathing tube with heated wire G-316003-00 /
Breathing system filter 800-51700 /
Disposal reservoir bag (2 l) 504-012-50430600 /
Breathing reservoir bag -2 l G-118004 /
Breathing reservoir bag (test lung) -2 l 800-21001 /
Breathing reservoir bag (test lung) -60 ml, type: infant G-118000-0 /
Mask for infant 5312 /
Mask for adult 5315 /
Mask for pediatric 5313 /
Disposable nebulizer set M-0801 /
Nasal cannula -small Adult use OPT942 /
Nasal cannula -medium Adult use OPT944 /
Nasal cannula -large Adult use OPT946 /
Nasal cannula-small RVL001S /
Nasal cannula -medium RVL001M /
Nasal cannula -large RVL001L /
Headgear for CPAP mask S, Silicon DCA100 /

II-3
 Appendix III Product Specifications

Expiratory volume monitor, pressure measurement unit and control unit have been integrated in the ventilator.
Alarm system, O2 monitor, CO2 monitor and SpO2 monitor are configured in the ventilator. Where:
 The expiratory volume monitor, pressure measurement unit and pressure release unit conform to ISO
80601-2-12;
 The alarm system conforms to IEC60601-1-8;
 The O2 monitor conforms to ISO 80601-2-55
 The CO2 monitor conforms to ISO 80601-2-55;
 The SpO2 monitor conforms to ISO 86061-2-61

(1) Product classification

Item Classification
Type of protection against Class I equipment (connected to a.c. supply mains),
electrical shock Class II equipment (connected to external d.c. power supply),
configurated with internal power supply source
The breathing tubing & veil, mask and nasal cannula are classified as type BF
applied part with defibrillation-proof.
Classification of applied
The CO2 sampling tube is classified as type BF applied part with
part
defibrillation-proof.
The SpO2 probe is classified as type CF applied part with defibrillation-proof.
Degree of safety for The equipment cannot be used with inflammable anesthetic gas mixed with air,
inflammable anesthetic gas oxygen or nitrous oxide.
Operating mode Continuous operation
Rating of protection IP21
against ingress of water Enclosure protection class according to IEC 60529:
and particular matters
Mobility Portable / Mobile equipment (mounted on trolley)

(2) Environmental Specification

Main unit
Item Temperature (ºC) Relative humidity Atmospheric pressure
(non-condensing) (kPa)
Operation 5 ~ 40 5% - 95 % 62.0 ~ 106
Storage –20～60 (O2 sensor: –20～50) 5% - 95 % 50 ~ 106
Transportation conditions: applicable for land, air and sea transportation.

(3) Hardware specification

Overall specification
Sound pressure level Not greater than 45 dB (A) (under standard working condition)
Sound power level 52 dBA

III-1
 Product Specifications

1389 ±10mm × 528±5 mm × 697 ±5mm (Height × Width ×Depth) (including trolley);
Standard size 343.5 ±5mm × 312.5±5 mm × 258 ±5mm (Height × Width × Depth) (excluding
trolley)
60±5kg (with all safe working load)
Weight
10±5kg (main unit)
Casters 4 pcs, each equipped with a brake pedal
Installation method Trolley
Trolley: 23kg
Retaining bracket of humidifier holder: 3kg
Maximum load Supporting Arm Fixing block: 2.5kg
Support tray for V3/V3A: 25 kg
Cylinder holder: 25kg
Display
Display size 12.1 inch
Resolution 1280 × 800 pixels
Touch Screen
Touch screen size 12.1 inch
Touch screen type Capacitive screen
LED lights
External power
Green. The light turns on when external power is connected
supply indicator
Power switch Namely the backlight of the power switch button (Green. The light turns on when in
indicator power-on state, and turns off when in power-off state).
The green light remains on: the battery is fully charged or the ventilator is powered by
the battery.
Battery status
The green light blinks: the battery is charging.
indicator
The light turns off: No battery installed or the battery failure or the ventilator isn’t
connected to external power supply (AC/DC) when it power off.
Yellow and red. When high and medium-priority alarms are generated simultaneously,
Alarm indicator
only the red light blinks.
Connector
Name Function
VGA connector Outputs VGA video signals with the same contents to the primary display and
connects to the external display (supporting display with resolution of 1920*1080).
USB connector Can export the configuration information and historical data (such as Patient data,
Alarm log, Calibration table) via the USB connector; transfer the configuration
between machines of the same model through the USB flash disk; and connect
ultrasonic nebulizer.
Nurse call connector Used to connect the Nurse call system in the hospital.
Contact Type : Normally closed or Normally open
Contact rating: 1A@60V d.c (Vpeak a.c)
Requirement for
breathing system 50 ml, bacteria filter efficiency: 99.99%；virus filter efficiency: 99.99%
bacteria filter

III-2
 Product Specifications

(4) Power Specification

External AC power supply

Input voltage 100 – 240 V~
Input frequency 50/60Hz
Input power 1.2-0.5A
Fuse T3AL/250V
External DC power supply
Input voltage 12V
Input current 10A
Internal battery
Number of
1 or 2
battery(s)
Battery type Lithium ion battery
Rated battery
14.4VDC
voltage
Battery capacity The capacity of single battery is 6700 mAh
Voltage supply time ≥140 min (when a new fully charged battery is used in standard operating mode)
≥280 min (when two new fully charged batteries are used in standard operating mode)

Note: Standard operating mode of the ventilator:

 Breathing mode: V-A/C

 Tidal volume: 500 ml
 Respiratory rate: 10 bpm
 Inspiratory time: 2.00s
 O2 concentration: 40 vol.%
 PEEP: 3cmH2O
 Rated operating pressure of Gas Supply: 400 ±100kPa
 CO2 monitoring is off
 SpO2 monitoring is off

(5) Data review

Name Specification
The graphic/tabular trends data of the latest 72-hours working parameter for a single
Trends data
patient can be saved.
Up to 8000 event logs can be saved, including alarm logs and operation logs. The
Event logs alarm log includes parameter alarm events, parameter waveforms related to the alarm
time and alarm inactivation action.
Freeze the waveform of the interface at the current time, and use the knob to review the
Freeze the
data. When freezing, 30 most recent historical waveforms can be reviewed by sliding
waveform review
the screen or rotating the knob.
Freeze the loop
Up to 5 reference loops can be saved.
review

III-3
 Product Specifications

(6) Ventilator specification

Ventilator control parameter specification

Parameter Range Step size
O2% 21vol.%~100vol.% 1 vol.%
TV Adult: 100~2200 ml, Pediatric: 20~300 ml Adult: 10 ml,Pediatric: 1 ml
Tinsp 0.10~10.00 s 0.05 s
Timax 0.2 ~ 15.0 s 0.1 s
I:E 4:1~1:10 0.5
Tpause (%) OFF, 5 ~ 60% 5%
Tslope 0.00~2.00 s 0.05 s
f 1~100 bpm 1 bpm
fsimv 1~60 bpm 1 bpm
ΔPinsp 5～80 cmH2O 1 cmH2O
ΔPsupp 0～80 cmH2O 1 cmH2O
PEEP OFF, 1~50 cmH2O 1 cmH2O
P-Trig -10.0～-0.5 cmH2O 0.5 cmH2O
Exp% 10～85%, Auto 5%
F-Trig 0.5 l/min～15.0 l/min 0.1 l/min
Phigh Plow～80 cmH2O 1cmH2O
Thigh 0.2~30.0 s 0.1 s
Plow 0～50 cmH2O 1 cmH2O
Tlow 0. 2~30.0 s 0.1 S
△int.PEEP OFF, 1~45 cmH2O 1 cmH2O
Tube I.D. Adult: 5.0 ~ 12.0 mm, Pediatric: 2.5 ~ 8.0 mm 0.5 mm
Compensate 1 ~100 % 1%
Flow (O2 Therapy) 2~60 l/min 1 l/min
Adult:100~2200 ml,
TVapnea Adult: 10 ml,Pediatric: 1 ml
Pediatric:20~300 ml
ΔPapnea 5～80 cmH2O 1 cmH2O
fapnea 1~80 bpm 1 bpm
Apnea Tinsp 0.20~10.00 s 0.05 s

Ventilator monitoring parameter specification

Parameter Range Resolution
Ppeak
Pplat -20～120 cmH2O 1 cmH2O
Pmean
PEEP 0～120 cmH2O 1 cmH2O
TVi
TVe 0～4000 ml 1 ml
TVe spn
MV
0.0～100.0 l/min 0.1 l/min
MVspn

III-4
 Product Specifications

MVleak
ftotal
fspn 0~200 bpm 1 bpm
fmand
FiO2 15%～100 vol.% 1 vol.%
Flow(BTPS) 0～100 l/min 0.1 l/min
Ri
0~600 cmH2O/l/s 1cmH2O/l/s
Re
Cstat
0~300 ml/ cmH2O 1ml/ cmH2O
Cdyn
RSBI 0~999 /(min·l) 1 /(min·l)
P0.1 -20.0～0.0 cmH2O 0.1 cmH2O
NIF -45.0～0.0 cmH2O 0.1 cmH2O
RCexp 0.0～10.0 s 0.1 s
WOB 0.0～100.0 J/min 0.1 J/min

(7) Ventilator Accuracy

Control accuracy
Parameter Accuracy (in standard state)
FiO2 ±(3 vol.% + 1% of the set value)
TV ±(10 ml + 10% of the set value)
ΔPinsp ±(2 cmH2O + 5% of the set value)
ΔPsupp ±(2 cmH2O + 5% of the set value)
Within the range of 1cmH2O~2cmH2O: ±1 cmH2O
PEEP Within the range of 2cmH2O～50cmH2O (exclude 2cmH2O) : ± (2 cmH2O + 5% of the
set value)
f ±1 bpm
fsimv ±1 bpm
Tinsp ±0.1s or ±10% of the set value, whichever is larger
Tslope ±(0.2s + 20% of the set value)
1:4~2:1: ±10% of the set value;
I:E
Other range: ±15% of the set value.
Phigh ±(2 cmH2O + 5% of the set value)
Within the range of 1cmH2O~2cmH2O: ±1 cmH2O
Plow Within the range of 2cmH2O～50cmH2O (exclude 2cmH2O) : ± (2 cmH2O + 5% of the
set value)
Thigh ±0.2s or ±10% of the set value, whichever is larger
Tlow ±0.2s or ±10% of the set value, whichever is larger
F-Trig ±(1 l/min + 10% of the set value)
P-Trig ±(1 cmH2O + ±10% of the set value)
Exp% ±10% (absolute error)
Flow (O2 Therapy) ±(1.5 l/min + 10% of the set value)(BTPS)
fapnea ±1bpm

III-5
 Product Specifications

△Papnea ±(2 cmH2O + 5% of the set value)

TVapnea ±(10 ml + 10% of the set value)
Apnea Tinsp ±0.1s or ±10% of the set value, whichever is larger
Within the range of 1cmH2O~2cmH2O: ±1 cmH2O
△int.PEEP Within the range of 2cmH2O～45cmH2O (exclude 2cmH2O) :± (2 cmH2O + 5% of the
set value)

Monitoring accuracy
Parameter Accuracy
TVi Within the range of 0 ml～100 ml, ±(10 ml + 3% of the actual reading);
TVe Within the range of 100 ml～4000 ml (not include 100 ml), ± (3 ml + 10% of the
TVe spn actual reading)
Ppeak Within the range of -20 cmH2O～120 cmH2O, ± (2 cmH2O + 4% of the actual
Pplat reading)
Pmean
Within the range of 0 cmH2O～2cmH2O: ±1 cmH2O
PEEP Within the range of 2 cmH2O～120cmH2O (exclude 2cmH2O): ± (2 cmH2O + 4% of
the actual reading)
MV Within the range of 0.0 l/min～100.0 l/min, ±(0.2 l/min + 10% of the actual reading)
MVspn
MVleak
ftotal Within the range of 0 bpm～200 bpm, ±1 bpm or ±5% of the actual reading,
fmand whichever is larger
fspn
Within the range of 15 vol.%～100 vol.%, ± (2.5 vol. % + 2.5% of the actual
FiO2*
reading).
Ri Within the range of 0 cmH2O/l/s ～ 5 cmH2O/l/s and 500 cmH2O/l/s ～
600cmH2O/l/s : the measurement accuracy is not defined.
Re
Within the range of 5 cmH2O/l/s~20 cmH2O/l/s: ±10 cmH2O/l/s;
Within the range of 20 cmH2O/l/s ～500 cmH2O/l/s (exclude 20cmH2O), ±50% of
the actual reading).
Cstat Within the range of 0 ml/ cmH2O～300 ml/ cmH2O, ± (2 ml/ cmH2O + 20% of the
Cdyn actual reading).
RSBI Within the range of 0 /(min·l)～999 /(min·l) , ± (3 /(min·l)+15% of the actual
reading).
NIF Within the range of -45.0 cmH2O～0.0 cmH2O, ± (2 cmH2O + 4% of the actual
reading)
Within the range of -20.0 cmH2O～0.0 cmH2O, ± (2 cmH2O + 4% of the actual
P0.1
reading).
WOB Within the range of 0.0 J/min～100.0 J/min, ±(1 J/min + 15% of the actual reading).
RCexp Within the range of 0.0s～10.0s, ±(0.2s + 20 % of the actual reading).
Within the range of 0.0 l/min～100.0 l/min: ± (1.5 l/min +10% of the actual
Flow (O2 Therapy)
reading)(BTPS)

III-6
 Product Specifications

The time required for the oxygen concentration in the delivery ventilation to change
Oxygen concentration from 21% to the maximum settable 90%:
controlling response When TV=500ml, f=10/min, I:E=1:2, ≤50s
time When TV=150ml, f=20/min, I:E=1:2, ≤100s
When TV=30ml, f=30/min, I:E=1:2, ≤100s
FiO2*: According to the drift test method for measurement accuracy as specified in ISO 80601-2-55, the
measurement accuracy can be ensured to meet the requirement in this table.

(8) CO2 module specification

Sidestream CO2 module

Range of Comen sidestream: 0 mmHg～150 mmHg, 0%～19.7%, 0 kPa～20 kPa (at 760 mmHg)
measurement Respironics Capno sidestream: 0 mmHg～99 mmHg, 0.0 %～13.0 %, 0 kPa～13.2 kPa (at
760 mmHg)
Masimo ISA Capno sidestream: 0 mmHg～190 mmHg, 0 % ～ 25 % (at 760 mmHg)
Accuracy Comen sidestream:
a) Within the range of 0 mmHg～40 mmHg, ±2 mmHg;
b) Within the range of 41 mmHg～70 mmHg, ±5% of the reading;
c) Within the range of 71 mmHg～100 mmHg, ±8% of the reading;
d) Within the range of 101 mmHg～150 mmHg, ±10% of the reading.
Respironics Capno sidestream:
0 mmHg～38 mmHg: ±2 mmHg,
39 mmHg～99 mmHg: ±10% of the actual reading.
Masimo ISA Capno sidestream:
a) Within the range of 0 mmHg ～114 mmHg, ±(2.25 mmHg + 4% of the reading).
b) Within the range of 115 mmHg ～190 mmHg, the accuracy is not defined.
Sampling Comen sidestream: sampling rate: 50 ml/min; sampling rate control accuracy: ±10ml/min;
Rate and Respironics Capno sidestream: sampling rate: 50 ml/min; sampling rate control accuracy: ±
Rate Control 10 ml/min.
Accuracy Masimo ISA Capno sidestream: sampling rate: 50ml/min; sampling rate control accuracy: ±
10 ml/min.
Masimo ISA Capno sidestream: < 3s
Total system
Respironics Capno CO2: Less than 3 seconds (with dehumidification and extension tubing).
response time
Comen sidestream CO2: Less than 3 seconds (with dehumidification and extension tubing).
Masimo ISA Capno sidestream: Typical rise time at 50 ml/min sample flow: ≤200ms
10% to 90%
Respironics Capno CO2: Less than 410 ms (with dehumidification and extension tubing)
Rise time
Comen sidestream CO2: Less than 410 ms (with dehumidification and extension tubing)
Masimo ISA Capno sidestream: ET CO2 are displayed after one breath and have a
continuously updated breath average；
Respironics Capno CO2: Range: 0, 5 to 99 mmHg
EtCO2 Method: Peak of the expired CO2 waveform over selected time period. Minimum of 5 mmHg
Calculation between peak and valley of waveform required.
Time Period Selections: 10 second, 20 second
Comen sidestream CO2: Method: Peak of the expired CO2 waveform.
Selections: 1 breath, 10 second, 20 second.

III-7
 Product Specifications

CO2 Stability Masimo ISA Capno sidestream: No drift

Respironics Capno CO2: Short Term Drift: Drift over 6 hours shall not exceed 0.80 mmHg
maximum.
Long Term Drift: Accuracy specification will be maintained over a 120 hour period.
Comen sidestream CO2: Short Term Drift: Drift over four hours shall not exceed 0.8 mmHg
maximum.
Long Term Drift: Accuracy specification will be maintained over a 120 hour period.

Sidestream CO2 alarm specification

Item Range Step Note
EtCO2 High Comen sidestream: 2 mmHg～150 mmHg 1 mmHg Set the high limit to
Limit Respironics Capno sidestream: 2 mmHg～99 mmHg be greater than the
low limit
Masimo ISA Capno sidestream: 2 mmHg～190 mmHg
EtCO2 Low Comen sidestream: 0 mmHg～148 mmHg
Limit Respironics Capno sidestream: 0 mmHg～97 mmHg
Masimo ISA Capno sidestream: 0 mmHg～188 mmHg

Sidestream CO2 sensor environment specification

Relative humidity
Item Temperature (ºC) Atmospheric pressure (kPa)
(non-condensing)
Operation Respironics: 0~55 Respironics:10~95% Respironics:53.3~106.6
Comen: 0～55 Comen: 10~95% Comen: 53.3 ～106.6
Storage Respironics:-40~＋70 Respironics:10~95% Respironics: 50~106
Comen: -40~＋70 Comen: 10~95% Comen: 50 ～106

Mainstream CO2 module specification

Item Range
Range of Comen mainstream: 0 mmHg～150 mmHg,0%～19.7%,0 kPa～20 kPa (at 760 mmHg);
measurement Respironics CAPNOSTAT 5: 0 mmHg～150 mmHg, 0%～19.7%, 0 kPa～20 kPa (at 760
mmHg);
Masimo IRMATM mainstream: 0 mmHg～190 mmHg, 0 % ～ 25 % (at 760 mmHg);
Accuracy Comen mainstream:
a) Within the range of 0mmHg～40mmHg, ±2 mmHg;
b) Within the range of 41mmHg～70mmHg, ±5% of the reading;
c) Within the range of 71mmHg～100mmHg, ±8% of the reading;
d) Within the range of 101mmHg～150mmHg, ±10% of the reading.
Respironics CAPNOSTAT 5 mainstream:
a) Within the range of 0 mmHg～40 mmHg, ±2 mmHg;
b) Within the range of 41 mmHg～70 mmHg, ±5% of the reading;
c) Within the range of 71 mmHg～100 mmHg, ±8% of the reading;
d) Within the range of 101 mmHg～150 mmHg, ±10% of the reading.
Masimo IRMATM mainstream:
a) Within the range of 0 mmHg ～114 mmHg, ±(2.25 mmHg + 4% of the reading);

III-8
 Product Specifications

b) Within the range of 114 mmHg ～190 mmHg, the accuracy is not defined;
Total System Masimo IRMA mainstream: <1s
Response Time Respironics CAPNOSTAT 5 and COMEN CO2: < 1s
CO2 Stability Masimo IRMA mainstream: No drift
Respironics CAPNOSTAT 5 and COMEN CO2: Short Term Drift: Drift over four hours
shall not exceed 0.8 mmHg maximum; Long Term Drift: Accuracy specification will be
maintained over a 120 hour period.
EtCO2 Masimo IRMATM mainstream: ETCO2 is displayed after one breath and have a continually
Calculation updated breath average. The following methods are used to calculate end-tidal (ET) values:
The highest concentration of CO2 during one breathing cycle with a weight function applied
to favor values closer to the end of the cycle. ETCO2 will be within specification for all
respiratory rates up to 150 bpm.
Respironics CAPNOSTAT 5 and COMEN CO2:
Method: Peak of the expired CO2 waveform
Selections: 1 breath, 10 second, 20 second
Note: the minimum reported differential value between the baseline and the
CO2 value shall be 5 mmHg.
Sampling Rate Masimo IRMA mainstream: sample rate 20 Hz / channel
Respironics CAPNOSTAT 5 and COMEN CO2: 100 Hz

Mainstream CO2 alarm specification

Name Range Step Note
EtCO2 High Comen mainstream: 2 mmHg ～150 mmHg 1mmHg Set the high
Limit Respironics CAPNOSTAT 5 mainstream: 2mmHg ～150 mmHg limit to be
greater than
Masimo IRMA 2 mmHg ～190 mmHg
thelow limit
EtCO2 Low Comen mainstream: 0 mmHg～148 mmHg
Limit Respironics CAPNOSTAT 5 mainstream: 0 mmHg～148 mmHg
Masimo IRMA mainstream: 0 mmHg～188mmHg

Mainstream CO2 sensor environment specification

Relative humidity Atmospheric pressure
Item Temperature (ºC)
(non-condensing) (kPa)
Operation Comen/Respironics: 0~45 Respironics:10~90% Comen/Respironics:
Masimo: 0~40 Comen: 10~95% 53.3～106.6
Masimo: ＜95% Masimo: 52.5~120
Storage Comen/Respironics: Comen/Respironics: ＜90% Comen/Respironics:
-40～70 Masimo: 5～100% 50~106
Masimo: -40~＋75 Masimo: 50~120

(9) SpO2 module specification (only applicable for V3)

SpO2 module
Display Pulse rate (PR) waveform/parameter, SpO2
SpO2 measurement Nellcor SpO2: 0%～100%
range Masimo SpO2: 1%～100%

III-9
 Product Specifications

Comen SpO2: 0%～100%

SpO2 accuracy Nellcor SpO2: Within the range of 70% ～ 100%, Adult/Pediatric measurement
accuracy is ±3% (during non-motion state); Within the range of 0% ～ 69%,
measurement accuracy is not defined.
Masimo SpO2: Within the range of 70% ～ 100%, Adult/Pediatric measurement
accuracy is ±3 % (during non-motion state),; Within the range of 1%～69%, the
measurement accuracy is not defined.
Comen SpO2: Within the range of 70% ～ 100%, Adult/ Pediatric measurement
accuracy is ±3% (during non-motion state); Within the range of 0%～69%, the
measurement accuracy is not defined.
PR measurement Nellcor SpO2: 20 bpm～300 bpm
range Masimo SpO2: 25 bpm～240 bpm
Comen SpO2: 20 bpm～254 bpm
PR measurement Nellcor SpO2: resolution: 1 bpm
resolution Masimo SpO2: resolution: 1 bpm
Comen SpO2: resolution: 1 bpm
PR measurement Nellcor SpO2: 20 bpm～250 bpm: the measurement error should be ±3 bpm; 251～300
accuracy (during bpm: measurement accuracy is not defined.
non-motion state) Masimo SpO2: 25 bpm～240 bpm: the measurement error should be ±3 bpm
Comen SpO2: 20 bpm～254 bpm : the measurement error should be ±2 bpm
Perfusion index Nellcor SpO2: / (Note: Nellcor SpO2 module has no perfusion index.)
Masimo SpO2: Measurement range : 0.02%～20%, accuracy: not defined
Resolution:
0.02%~9.99%, resolution: 0.01%.
10.0%~20.0%, resolution: 0.1%.
Comen SpO2: 0.05~20%; accuracy: not defined.
Resolution:
0.05%~9.99%, resolution: 0.01%,
10.0%~20.0%, resolution: 0.1%.
Data update period 1s
Signal Quality Masimo SpO2 and Comen SpO2 are configured with SIQ indication function
Index (SIQ)
indication function
Regulatory should conform to the requirements of ISO 80601-2-61
compliance

SpO2 alarm limit Range Step Note

specification
SpO2 High Limit Nellcor SpO2: lower +1 %～100 % 1% Set the high
Masimo SpO2: lower +1 %～100 % alarm limit to
Comen SpO2: lower +1 %～100 % be greater than
SpO2 Low Limit Nellcor SpO2: 0 %～upper-1 % the low limit

III-10
 Product Specifications

Masimo SpO2: 1 %～upper-1 %

Comen SpO2: 0 %～upper-1 %
PR High Limit Nellcor SpO2: 21 bpm～300 bpm 1 bpm
Masimo SpO2: 26 bpm～240 bpm
Comen SpO2: 21 bpm～254 bpm
PR Low Limit Nellcor SpO2: 20 bpm～299 bpm
Masimo SpO2: 25 bpm～239 bpm
Comen SpO2: 20 bpm～253 bpm

(10) O2 sensor specifications

Name Specifications
1.5 x 106 % measurement time at 20°C
Expected operation life
0.8 x 106 % measurement time at 40°C
Thermal compensation Fluctuation of ±2% within the range 0-40°C
Barometric pressure
Automatic barometric pressure compensation configured
compensation
Pressure range 50~200 kPa
Total system response <15s
time of O2 sensor

(11) Pneumatic system specification

Gas Supply
Gas type O2
Gas Supply requirement Compressed medical gas oxygen
High-pressure O2 source
Gas Supply pressure range 280～600 kPa
Flow 120 l/min (STPD)
Input connector NIST (ISO 5356-1) or DISS (CGA 1240)
Hose compliance standard EN ISO5359
Low-pressure O2 source
Input pressure range < 100 kPa
Maximum flow rate 15 l/min
Input connector CPC quick coupling
Inspiratory module
Peak flow rate ≥ 210 l/min
Nebulizer connector Flow rate: 5 l/min～8 l/min
Safety pressure of breathing ≤ 12.5 kPa
Inspiratory-side external Coaxial 22 mm/15 mm conical connector
connector
Removable, sterilizable Detachable for clean and sterile and be installed.
Connector compliance standard EN ISO 5356-1
Expiratory module
Expiratory-side external Coaxial 22 mm/15 mm conical connector

III-11
 Product Specifications

connector
Removable, sterilizable Detachable for clean and sterile and be installed.
Regulatory compliance EN ISO5356-1
System compliance and resistance
Compliance VBS compliance: 0 to 5 mL/cmH2O.
VBS when configured with Adult disposable circuit: ≤ 4 ml/cmH2O;
VBS when configured with Adult reusable circuit: ≤ 2 ml/cmH2O;
VBS when configured with Pediatric disposable circuit: ≤ 2 ml/cmH2O;
VBS when configured with Pediatric reusable circuit: ≤ 2 ml/cmH2O;
VBS when configured with Infant reusable circuit: ≤ 1 ml/cmH2O.
Inspiratory resistance ≤ 6 cmH2O at the flow rate of 60 l/min (with adult breathing tube);
≤ 6 cmH2O at the flow rate of 30 l/min (with pediatric breathing tube);
≤ 6 cmH2O at the flow rate of 5 l/min (with infant breathing tube).
Expiratory resistance ≤ 6 cmH2O at the flow rate of 60 l/min (with adult breathing tube);
≤ 6 cmH2O at the flow rate of 30 l/min (with pediatric breathing tube);
≤ 6 cmH2O at the flow rate of 5 l/min (with infant breathing tube).
Biocompatibility of breathing gas pathwaye
Gas compatibility Meet the requirements of ISO18562

(12) Adjustable parameter alarm

Parameter Range Step Note

Adult: 110~4000 ml, OFF
High Limit 5 ml
Pediatric: 25~600 ml, OFF
TV
Adult: OFF, 50~3995 ml
Low Limit 5 ml
Pediatric: OFF, 10~595 ml
Adult: 0.2~100.0 l/min
High Limit 0.1 l/min
Pediatric: 0.2~60.0 l/min
MV
Adult: 0.1~50.0 l/min
Low Limit 0.1 l/min
Pediatric: 0.1~30.0 l/min
High Limit 20 vol.%～100 vol.% 1 vol.% Set the high
FiO2(LPO)
Low Limit 18 vol.%～ 98 vol.% 1 vol.% limit to be
Min (Oxygen concentration setting value + max greater than
High Limit the low limit
(7 vol.%, oxygen concentration setting value x /
10%), 100 vol.%) (rounded)
FiO2(HPO)
Max (18 vol.%, oxygen concentration setting
Low Limit value-max (7 vol.%, oxygen concentration /
setting value x 10%)) (rounded)
High Limit 10~90 cmH2O. 1 cmH2O
Paw
Low Limit OFF,5~ upper -5 cmH2O 1 cmH2O
High Limit 2~160 bpm, OFF 1 bpm
ftotal
Low Limit OFF,1~159 bpm 1 bpm
Tapnea 5~60s 1s Error: ±3s

III-12
 Appendix IV Default Settings

(1) Setup
Setup Factory default values
Setup - Setting - System - Tinsp/I:E Tinsp
Setup - Setting - System - IBW/Hight Height
Setup - Setting - System - DuoVent Setup Thigh
Setup - Setting - System - Invasive Apnea Mode Pressure Control
Setup - Setting - System -TVI/IBW 7 ml/kg
Setup - Setting - Brightness/Volume - Key Volume 2
Setup - Setting - Brightness/Volume - Brightness 5
Setup - Setting - Brightness/Volume - Screen Mode Day
Setup - Setting - Brightness/Volume - Auto Adjustment OFF
Setup - Setting - Date/Time - Date Format YYYY-MM-DD
Setup - Setting - Date/Time - Time Format 24 h
Setup - Setting - Waveform - Waveform Count 3
Setup - Setting -Waveform – Draw Wave Curve
Setup – Sensor - O2 - Monitoring ON

(2) CO2 Module

CO2 Module Default settings
Setup – Sensor - CO2 - Monitoring ON
Respironics: 40%,
Setup – Sensor - CO2 - O2 Compensation Comen: 40%,
Masimo: Medium.
Setup – Sensor - CO2 - Altitude 0.0 m

(3) SpO2 Module (only applicable in V3)

Masimo SpO2:
SpO2 Module Factory default settings
Setup – Sensor - SpO2 - Monitoring ON
Setup – Sensor - SpO2 - Signal Indication OFF
Setup – Sensor - SpO2 – Fast Sat OFF
Setup – Sensor - SpO2 – Smart Pulse Sound ON
Setup – Sensor - SpO2 – Sweep Speed 25 mm/s
Setup – Sensor - SpO2 – Sensitivity APOP
Setup – Sensor - SpO2 – Average Time 8s
Setup – Sensor - SpO2 – Pulse Volume 2
Setup – Sensor - SpO2 – SatSeconds Forbid

Nellcor SpO2:
SpO2 Module Factory default settings
Setup – Sensor - SpO2 - Monitoring ON
Setup – Sensor - SpO2 – Sweep Speed 25 mm/s

IV-1
 Default Settings

Setup – Sensor - SpO2 – Pulse Volume 2

Setup – Sensor - SpO2 – SatSeconds Forbid

Comen SpO2:

SpO2 Module Factory default settings

Setup – Sensor - SpO2 - Monitoring ON
Setup – Sensor - SpO2 - Signal Indication OFF
Setup – Sensor - SpO2 – Sweep Speed 25 mm/s
Setup – Sensor - SpO2 – Sensitivity High.
Setup – Sensor - SpO2 – Pulse Volume 2

(4) Ventilation Parameters

Ventilation mode Factory default settings
parameter settings
TV Adult: 500 ml, Pediatric: 100 ml.
O2% 40 vol.%
I:E 1:2
PEEP 3 cmH2O
Phigh 15 cmH2O
ΔPinsp 15 cmH2O
Plow 3 cmH2O
ΔPsupp In PSV-S/T mode:15 cmH2O; in other modes:10 cmH2O
Tslope 0.20s
Tpause(%) OFF
f Adult: 15 bpm, Pediatric: 20 bpm.
fsimv Adult: 5 bpm, Pediatric: 15 bpm.
Thigh Adult: 1.7 s, Pediatric: 1.0 s.
Tlow Adult: 3.3 s, Pediatric: 2.0 s.
Tinsp Adult: 1.30 s, Pediatric: 1.00 s.
Timax Adult: 1.70 s, Pediatric: 1.00 s.
F-Trig / P-Trig Default F-Trig: Adult: 2.0 l/min, Pediatric: 1.0 l/min.
Exp% 25%
Assist ON
Apnea Vent ON
ΔPapnea 15 cmH2O
fapnea Adult: 12 bpm, Pediatric: 20 bpm.
TVapnea Adult: 500 ml, Pediatric: 100 ml.
Apnea Tinsp Adult: 1.30 s, Pediatric: 1.00 s.
Sigh OFF
Interval 1 min
Cycles Sigh 3
△int.PEEP OFF
Tube Type Disable TRC
Tube I.D. Adult: 8.0 mm,Pediatric: 5.0 mm.
Compensate 80%

IV-2
 Default Settings

Expiration ON

(5) Alarms
Alarms Factory default settings
Paw High Limit 40 cmH2O
Paw Low Limit OFF
MV High Limit Adult: 9.0 l/min, Pediatric: 3.0 l/min
MV Low Limit Adult: 3.6 l/min, Pediatric: 1.2 l/min
TVe High Limit Adult: 1000 ml, Pediatric: 200 ml
TVe Low Limit Adult: 250 ml, Pediatric: 50 ml
ftotal High Limit OFF
ftotal Low Limit OFF
Tapnea 15s
FiO2 High Limit 47 vol.%
FiO2 Low Limit 33vol.%
EtO2 High Limit 50 mmHg
EtO2 Low Limit Adult: 15 mmHg, Pediatric: 20 mmHg
SpO2 High Limit 100 %
SpO2 Low Limit 90 %
PR High Limit Adult: 120 bpm, Pediatric: 160 bpm
PR Low Limit Adult: 50 bpm, Pediatric: 75 bpm
SpO2 High Level Med
SpO2 Low Level Med
PR High Level Med
PR Low Level Med
SpO2 ON
PR ON
Alarm Volume 5

(6) History
History Factory default settings
History - Graphic Trend - Display Group All
History - Graphic Trend - Interval 10 min
History - Tabular Trend - Display Group All
History - Tabular Trend - Interval 1 min
History – Event Logbook - Filter All Events

(7) Special Functions

Special functions Factory default settings
Nebulizer - Time 30 min
Tools - P-V Tools – Measure - Pstart 3 cmH2O
Tools - P-V Tools – Measure - Pmax 15 cmH2O
Tools - P-V Tools – Measure - Flow 6 l/min
Tools - P-V Tools – Measure - Vlimit 770 ml
Tools - P-V Tools – Analysis – Ref. Loop Hide
Tools - SI - Measure – Pressure Hold Adult: 35 cmH2O, Pediatric: 20 cmH2O
Tools - SI - Measure – Hold Time Adult: 30 s, Pediatric: 15 s

IV-3
 Default Settings

(8) User Maintenance

User Maintenance Factory default values
Settings – Gas Supply – O2 Gas Supply Type HPO
Settings – Unit – CO2 Unit mmHg
Settings – Unit – Weight Unit kg
Settings – Unit – Paw Unit cmH2O
Settings – Other – Minimum Alarm Volume 1
Interface – Nurse Call – Switch OFF
Interface – Nurse Call – Signal Type Continuous
Interface – Nurse Call – Contact Type Normally Closed
Interface – Nurse Call – Alarm Level High Alarm, Med Alarm
Interface – Nurse Call – Alarm Type Phys. Alarm, Tech. Alarm

(9) O2 Therapy
O2 Therapy Factory default settings
O2 Therapy - O2% 40 vol.%
O2 Therapy - Flow Adult: 25 l/min, pediatric: 8 l/min
O2 Therapy - O2 Therapy Timer 0 min

(10) Other
Patient Factory default settings
Weight Adult: 70 kg, Pediatric: 15.4 kg
Gender Male
Height Adult: 174 cm, Pediatric: 100 cm
Ventilation type Invasive

IV-4
 Appendix V Alarm Messages

All alarm levels of the ventilator have been set in factory and cannot be changed by the user.
For each alarm message, the corresponding countermeasures are listed. If the alarm still persists after
following the countermeasures, please contact the maintenance personnel.

1) Physiological Alarm

Alarm messages Alarm level Causes and solutions

The airway pressure exceeds the set pressure high alarm limit.
1. Check the patient.
Paw Too High H 2. Check the ventilation parameter setup.
3. Check the alarm limits.
4. Check the patient tubing for occlusion.
Airway pressure setting is lower than the low limit of pressure alarm.
1. Check the patient.
Paw Too Low H 2. Check the ventilation parameter setup.
3. Check the alarm limits.
4. Check if the patient tubing are leaked or disconnected.
The inspired O2 concentration is greater than the FiO2 high alarm limit for
at least 30s.
1. Check the ventilation parameter setup.
FiO2 Too High H
2. Check the alarm limits.
3. Check the HEPA filter for occlusion.
4. Calibrate the O2 sensor.
The inspired O2 concentration has been lower than the FiO2 low alarm
limit for at least 30s or is less than 18%.
1. Check the ventilation parameter setup.
FiO2 Too Low H
2. Check the alarm limits.
3. Check the O2 supply.
4. Calibrate the O2 sensor.
The TVe monitored value is greater than TVe high alarm
limit for continuous 3 mechanical ventilation cycles.
TVe Too High M
1. Check the ventilation parameter setup.
2. Check the alarm limits.
The TVe monitored value is less than TVe low alarm limit for continuous
3 mechanical ventilation cycles.
1. Check the patient.
TVe Too Low M 2. Check the ventilation parameter setup.
3. Check the alarm limits.
4. Check the patient tubing for leakage or occlusion.
5. Perform System Check to test the leakage.
MV Too High H The TVe monitored value is greater than TVe high alarm

V-1
 Alarm Messages

Alarm messages Alarm level Causes and solutions

limit for continuous 3 mechanical ventilation cycles.
1. Check the ventilation parameter setup.
2. Check the alarm limits.
MV is less than MV low alarm limit.
1. Check the ventilation parameter setup.
MV Too Low H 2. Check the alarm limits.
3. Check the patient tubing for leakage or occlusion.
4. Perform System Check to test the leakage.
The time of failure to detect respiration exceeds Tapnea.
1. Check the patient.
Apnea H 2. Manual breath.
3. Check apnea time setup.
4. Check if the patient tubing are disconnected.
The time of failure to detect respiration exceeds Tapnea. Start apnea
Apnea Ventilation H ventilation mode.
Check apnea ventilation parameter setup.
ftotal is greater than ftotal high alarm limit.
1. Check the patient.
ftotal Too High M
2. Check the ventilation parameter setup.
3. Check the alarm limits.
ftotal is lower than the ftotal low alarm limit.

ftotal Too Low M 1. Check the patient.

2. Check the ventilation parameter setup.
3. Check the alarm limits.
Apnea Ventilation This alarm is given when apnea ventilation ends. There is no need to
L
Ended process this alarm.

The monitored parameter value exceeds the alarm limit.

EtCO2 Too High M 1. Check the patient type.
2. Check the alarm limits.

The monitored parameter value exceeds the alarm limit.

1. Check the patient type.
2. Check the alarm limits.
EtCO2 Too Low M
1. Check the patient.
2. Check apnea time setup.
3. Check the connections of CO2 module sampling device.

SpO2 value is greater than the high alarm limit.

SpO2 Too High H or M 1. Check the patient’s condition and ventilator settings.
2. Check the patient’s inspiratory O2%.

V-2
 Alarm Messages

Alarm messages Alarm level Causes and solutions

3. Check the alarm limits.

SpO2 value is lower than the low alarm limit.

1. Check the patient’s condition and ventilator settings.

SpO2 Too Low H or M
2. Check the patient’s inspiratory O2%.
3. Check the alarm limits.

PR value exceeds the high alarm limit.

1. Check the patient's condition.

PR Too High H or M
2. Check ventilator settings.
3. Check the alarm limits.

PR value is lower than the low alarm limit.

1. Check the patient's condition.

PR Too Low H, M or L
2. Check ventilator settings.
3. Check the alarm limits.

2) Technical Alarm

Alarm messages Alarm level Causes and solutions

The temperature of battery 1 is higher than expected.
Battery1 Failure 01 H
Contact your service personnel.

Battery 1 Charge Failure

Battery1 Failure 02 H
Contact your service personnel.

Battery 1 Aging
Battery1 Failure 03 H
Contact your service personnel.

Battery 1 Comm Error

Battery1 Failure 04 H
Contact your service personnel.

Battery 1 Failure
Battery1 Failure 05 H
Contact your service personnel.

The temperature of battery 2 is higher than expected.

Battery2 Failure 01 H
Contact your service personnel.

Battery 2 Charge Failure

Battery2 Failure 02 H
Contact your service personnel.

Battery2 Failure 03 H Battery 2 Aging

V-3
 Alarm Messages

Alarm messages Alarm level Causes and solutions

Contact your service personnel.

Battery 2 Comm Error

Battery2 Failure 04 H
Contact your service personnel.

Battery 2 Failure
Battery2 Failure 05 H
Contact your service personnel.

Battery Temp. High. Battery temperature is a bit high during discharge.

M
Connect Ext. Power Connect to the external power supply.

Battery temperature is too high during discharge. The system may

Battery Temp. High. be down.
H
Sys Maybe Down
Connect to the external power supply.

The current system is powered by battery.

Battery in Use L
Connect to the external power supply.

Low Battery. Connect The remaining battery power is lower than a threshold.
M
Ext. Power. Connect to the external power supply.

Battery power is depleted. The system will shut down in a few

System DOWN minutes.
H
Connect Ext. Power.
Connect to the external power supply immediately.

Battery is not available in the current system.

Battery Undetected H
Contact your service personnel

Buzzer Failure.
Technical Error 21 M
Contact your service personnel.

Fan speed error.

Fan Failure M Restart the machine if the error cannot be corrected.Contact your
service personnel.

PowerBoard Charging Voltage Error.

Device Failure 70 H
Contact your service personnel.

AC Power Supply Voltage Error.

Device Failure 71 H
Contact your service personnel.

DC Power Supply Voltage Error.

Device Failure 72 H
Contact your service personnel.

V-4
 Alarm Messages

Alarm messages Alarm level Causes and solutions

System total Power Supply Voltage Error.
Device Failure 73 H
Contact your service personnel.

Power Supply Voltage Error.

Device Failure 74 H
Contact your service personnel.

Communication error between power board and main control board

Comm Error 75 H
Contact your service personnel.

Blower Temperature too High

Blower Failure 01 H
Contact your service personnel.

Turbine blower Temp Sensor Failure.

Blower Failure 02 M
Contact your service personnel.

HEPA Pressure Sensor Failure.

Blower Failure 03 H
Contact your service personnel.

Blower hardware failure

Blower Failure 04 H
Contact your service personnel.

Blower failed.
Blower Failure 05 H
Contact your service personnel.

Inspiratory flow sensor malfunction.

Insp. Limb Failure 06 H
Contact your service personnel.

Insp. Pressure sensor failure

Insp. Limb Failure 07 H
Contact your service personnel.

The suction valve falls off.

Insp. Limb Failure 08 H
Contact your service personnel.

Exp flow sensor failure

Exp. Limb Failure 10 H
Contact your service personnel.

Exp Pressure sensor failure

Exp. Limb Failure 11 H
Contact your service personnel.

Exhalation valve failure

Exp. Limb Failure 12 M
Contact your service personnel.

O2 Limb Failure 15 H O2 flow sensor failure

V-5
 Alarm Messages

Alarm messages Alarm level Causes and solutions

Contact your service personnel.

O2 proportional valve failure

O2 Limb Failure 16 H
Contact your service personnel.

Abnormal power supply of protection module

Device Failure 20 H
Contact your service personnel.

Safety valve failure

Device Failure 21 H
Contact your service personnel.

The communication between the monitoring board and the main

Comm Error 23 H control board is abnormal.

Contact your service personnel.

The communication between the monitoring board and the backup

Comm Error 24 H CPU is abnormal.

Contact your service personnel.

HEPA filter pressure sensor failure.

Technical Error 01 M
Contact your service personnel.

Atmospheric pressure sensor failure..

Technical Error 02 M
Contact your service personnel.

Insp. Temp Sensor Failure.

Technical Error 03 M
Contact your service personnel.

Nebulizer Valve Failure.

Technical Error 05 M
Contact your service personnel.

Insp.pressure three-way valve failure

Technical Error 06 M
Contact your service personnel.

Blower pressure three-way valve failure

Technical Error 07 M
Contact your service personnel.

Exp.pressure three-way valve failure

Technical Error 08 M
Contact your service personnel.

Exp. flow three-way valve failure

Technical Error 09 M
Contact your service personnel.

Blower Temp. Too H Blower Temperature exceeds a certain threshold.

V-6
 Alarm Messages

Alarm messages Alarm level Causes and solutions

High 1. Check whether the working environment temperature of the
machine exceeds the maximum working temperature claimed by the
manufacturer.
2. Check whether the fan inlet and outlet are blocked. If it is
blocked, clean up foreign objects and dust.

Replace the HEPA HEPA filter occluded, resistance increased.

L
Filter Contact your service personnel.

Device Temp. Too Device Temp Too High

H
High Contact your service personnel.

The gas temperature exceeds 55℃.

Insp. Gas Temp. Too 1. Disconnect the patient.
H
High
2. Restart the machine. Contact the specified service personnel if the
issue persists.

Air Flow Sensor Type Installation error with air flow sensor.
H
Error Contact your service personnel.

O2 Flow Sensor Type Installation error with O2 flow sensor.

H
Error Contact your service personnel.

O2 Sensor The O2 sensor is not connected.

L
Unconnected Connect the O2 sensor.

Calibrate the flow sensor.

Calibrate Flow Sensor H
Please perform flow calibration.

Calibrate Pressure Calibrate the pressure sensor.

H
Sensor Contact your service personnel.

The chemical O2 sensor is expired.

Replace O2 Sensor. M
Please replace the O2 sensor.

Please calibrate the O2 sensor.

Calibrate O2 Sensor L
Please calibrate O2 concentration.

Calibrate the O2 proportional valve

Calibrate O2 Valve H
Please perform O2valve calibration.

Calibrate the Insp. valve

Calibrate Insp. Valve H
Please calibrate the Insp. valve

V-7
 Alarm Messages

Alarm messages Alarm level Causes and solutions

Calibrate the Exp. valve
Calibrate Exp. Valve H
Please calibrate the Exp. valve

Watchdog error.
Watchdog Failure H
Contact your service personnel.

O2 pressure is low or high-pressure O2 is not connected.

O2 Supply Failure H 1. Check connection with O2 supply.
2. Check O supply pressure.

Tube is occluded.
Airway Obstructed? H 1. Check and clean the patient tubing.
2. Check and clean the expiration valve.

Tube is disconnected.
Tube Disconnected? H
Re-connect the patient tubing.

Tube is leakage.
Airway Leak? L 1. Check the patient tubing for leakage.
2. Perform System Check to test the leakage

In volume mode, the pressure reaches Paw high alarm limit-5

cmH2O..

1. Check the patient.

Pressure Limited L 2. Check the ventilation parameter setup.
3. Check pressure high alarm limit.
The ventilator changes the inflation type to pressure control under a
pressure of [Paw high alarm limit-5 cmH2O]

In pressure mode, delivered gas volume exceeds the set TV high

limit.

Volume Limited L 1. Check the patient.

2. Check the ventilation parameter setup.
3. Check the alarm limits.

Pinsp is lower than the pressure setting value by 3 cmH2O or 1/3 of

the pressure setting value, whichever is less.

1. Check the patient.

Pinsp Not Achieved L
2. Check TV alarm limits.
3. Check the O2 supply.
4. Check the patient tubing for leakage.

V-8
 Alarm Messages

Alarm messages Alarm level Causes and solutions

5. Check the HEPA filter for occlusion.

The pressure reaches Paw high alarm limit-5 in sigh cycle.

1. Check the patient.

Pressure Limited in
L 2. Check pressure high alarm limit.
Sigh Cycle
3. Check the patient tubing for occlusion.
4. Consider to turn off sigh.

TVi is less than the TV setting value by more than 10 mL + 10 % of

the setting value.

1. Check the patient.

2. Check pressure high alarm limit.
TV Not Achieved L
3. Check the high-pressure gas supply or the HEPA filter for
occlusion.
4. Check the O2 supply.
5. Check the patient tubing for leakage or occlusion.

In PSV mode, Tinsp exceeds 4s for adult, 1.5s for pediatric, and the
maximum inspiration time set by the user for neonates for
continuous 3 cycles.
Tinsp Too Long L
1. Check the patient.
2. Check the ventilation parameter setup.
3. Check the patient tubing for leakage.

Monitored PEEP exceeds PEEP + 5 cmH2O within any fully

mechanical ventilation cycle.
PEEP Too High H
1. Check the ventilation parameter setup.
2. Check the patient tubing for occlusion.

Patient’s PEEP is less than the setting value to a certain extent.

PEEP Too Low M 1. Check the patient tubing for leakage.
2. Perform System Check to test the leakage

The airway pressure measured by any pressure sensor is greater than

the setting PEEP + 15 cmH2O for 15 s consecutively.
Sustained Airway
H 1. Check the patient.
Pressure
2. Check the ventilation parameter setup.
3. Check the patient tubing for occlusion.

V-9
 Alarm Messages

Alarm messages Alarm level Causes and solutions

Button cell is available in the system. But the clock is powered
Please Reset Date and down and reset.
L
Time
Re-set the date and time.

The button board communication is stopped, and the button is

Comm Error 30 M faulty.

Contact your service personnel.

The monitoring module communication is stopped.

Comm Error 31 H
Contact your service personnel.

The power board communication stops.

Comm Error 32 H
Contact your service personnel.

The voltage is abnormal.

Device Failure 50 H
Contact your service personnel.

The voltage is abnormal.

Device Failure 51 H
Contact your service personnel.

The voltage is abnormal.

Device Failure 52 H
Contact your service personnel.

The voltage is abnormal.

Device Failure 53 H
Contact your service personnel.

The voltage is abnormal.

Device Failure 54 H
Contact your service personnel.

The voltage is abnormal.

Device Failure 55 H
Contact your service personnel.

The voltage is abnormal.

Device Failure 56 H
Contact your service personnel.

The voltage is abnormal.

Device Failure 57 H
Contact your service personnel.

The voltage is abnormal.

Device Failure 58 H
Contact your service personnel.

The voltage is abnormal.

Device Failure 59 H
Contact your service personnel.

V-10
 Alarm Messages

Alarm messages Alarm level Causes and solutions

The voltage is abnormal.
Device Failure 60 H
Contact your service personnel.

The voltage is abnormal.

Device Failure 61 H
Contact your service personnel.

The voltage is abnormal.

Device Failure 62 H
Contact your service personnel.

The voltage is abnormal.

Device Failure 63 H
Contact your service personnel.

The voltage is abnormal.

Device Failure 64 H
Contact your service personnel.

The voltage is abnormal.

Device Failure 65 H
Contact your service personnel.

The communication between the VPM and the MCM is abnormal.

Comm Error 66 H
Contact your service personnel.

The communication between the VPM and the VCM is abnormal.

Comm Error 67 H
Contact your service personnel.

Hardkey is depressed continuously for more than 35s.

Key Error L
Contact your service personnel.

Rotary encoder is depressed continuously for more than 35s.

Rotary Encoder Error L
Contact your service personnel.

The communication between the KBM and the MCM is abnormal.

Comm Error 80 H
Contact your service personnel.
CO2 Comm Err H CO2 module cannot communicate normally with the main system.
Reboot the system. If the error reoccurs, contact the manufacturer
CO2 Comm Stop H
for maintenance.
CO2 Span
Calibrating... L CO2 Span Calibrating. Contact the manufacturer for maintenance.
(Masimo)
CO2 Span Cal Error
L Module Failure. Contact the manufacturer for maintenance.
(Masimo)
CO2 Line Blocked. Check and replace the sampling line; if the error
CO2 Line Blocked L
still exists, contact the manufacturer for maintenance.

V-11
 Alarm Messages

Alarm messages Alarm level Causes and solutions

Replace CO2 Adapter The adapter Failure. Check and replace the adapter; if the error still
L
(Masimo) exists, contact the manufacturer for maintenance.

The sampling line is not or poorly connected. Check and replace the
CO2 No Sampling
L sampling line; if the error still exists, contact the manufacturer for
Line
maintenance.

The adapter is not or poorly connected. Check and replace the

CO2 No Adapter
L adapter; if the error still exists, contact the manufacturer for
(Masimo)
maintenance.

CO2 Out Of Accuracy The measured value exceeds the nominal accuracy range. Follow the
L
Range nominal accuracy range specified by the manufacturer.
CO2 Temp Out Of
L Module Failure. Contact the manufacturer for maintenance.
Range
CO2 Need Zero L Need Zero is prompted.
CO2 Software Error
L An error occurs in the software. Reboot the device.
(Masimo)
CO2 Hardware Error An error occurs in the hardware. Check and replace the sensor; if the
L
(Masimo) error still exists, contact the manufacturer for maintenance.
CO2 Speed Out Of
L The module Failure. Contact the manufacturer for maintenance.
Bounds (Masimo)
CO2 Factory
Calibration Lost L The module Failure. Contact the manufacturer for maintenance.
(Masimo)
CO2 Pressure Over
L The module Failure. Contact the manufacturer for maintenance.
range (Masimo)
CO2 ID unmatched
L CO2 ID unmatched. Reinsert the module.
(Respironics,)
CO2 Need Calibrate
L Need Calibrate is prompted.
(Comen)
The SpO2 Sensor is disconnected with the finger. Check the
SpO2 Finger Off M
condition of SpO2 sensor.

The RRA sensor is not connected Check the sensor and replace it
SpO2 No Sensor L with a proper one if needed. Check or reinsert the sensor; if the error
still exists, contact the manufacturer for maintenance.

SpO2 Low Signal The SpO2 sensor is connected unreliably. Check if the SpO2 sensor
L
(Masimo,Comen) is connected properly.

The SpO2 sensor is connected unreliably or the patient moves his/her

Search Pulse L arm. Check the patient’s condition and if the SpO2 sensor is
connected properly.

V-12
 Alarm Messages

Alarm messages Alarm level Causes and solutions

SpO2 Low Perfusion Unsmooth peripheral circulation. Use another finger; or examine
L
(Masimo) whether the limb is compressed.

SpO2 Sensor Fault The sensor is fault. Check and replace the sensor; if the error still
L
(Masimo) exists, contact the manufacturer for maintenance.

Strong external interference. Check the connection of SpO2 lead

SpO2 Interference
L wire; check the patient’s condition and whether a big body
(Masimo)
movement is made.

The patient (sensor) receives too much light. The sensor is covered
SpO2 Too Much Light
L by a fabric. Check the SpO2 sensor is fixed well; block or reduce
(Masimo)
the light; Shield the sensor from light; relocate the sensor.

SpO2 module cannot recognize the sensor. Check and replace the
SpO2 Unknown
L sensor; if the error still exists, contact the manufacturer for
Sensor (Masimo)
maintenance.

SpO2 No Cable SpO2 cable is not connected. Check the RRA cable and replace it
L
(Masimo) with a proper one if needed.

SpO2 No Adhesive The SpO2 adhesive sensor is not connected. Check the SpO2
L
Sensor (Masimo) adhesive sensor and replace it with a proper one if needed.
SpO2 Module Error
L The module fails. Contact the manufacturer for maintenance.
(Masimo,Comen)
SpO2 module cannot communicate with the main system. Reboot the
SpO2 Comm Stop H system. If the error reoccurs, contact the manufacturer for
maintenance.

SpO2 module cannot communicate normally with the main system.

SpO2 Comm Err H Reboot the system. If the error reoccurs, contact the manufacturer
for maintenance.

There is a NELLCOR module error. The system is resetting. If

Nellcor Error,
L system resetting fails or the error still exists after you restart the
Resetting
Monitor, contact the manufacturer for maintenance.

SpO2 Sensor Fault The sensor is fault. Check and replace the sensor; if the error still
L
(Comen) exists, contact the manufacturer for maintenance.

V-13
 Appendix VI EMC

This equipment meets the requirements of EMC standard IEC 60601-1-2: 2014 standards. Under the test
conditions specified in standard IEC 60601-1-2: 2014 clause 8, the following basic performances were
checked:
 Inhaled tidal volume control accuracy
 Inhaled tidal volume monitoring accuracy
 CO2 monitoring accuracy
 O2 concentration control accuracy
 O2 concentration monitoring accuracy
 PEEP control accuracy and PEEP monitoring accuracy
 SpO2 monitoring accuracy

Note
 The V3/V3A Ventilator complies with the applicable EMC requirements in IEC 60601-1-2.
 Please follow the EMC instructions in the User’s Manual to install and use the V3/V3A Ventilator.
 Portable and mobile RF communication equipment may affect the performance of the V3/V3A
Ventilator . To protect the V3/V3A Ventilator against strong electromagnetic interference, please
keep it away from mobile phones, microwave ovens, etc.
 Refer to the attached guide and manufacturer’s statement.

WARNING

 Do not stack this product on/under or get it close to any other equipment. If you have to use it this
way, observe and verify whether it works properly in such condition first.
 Using any accessory or cable other than sold by the manufacturer as spare parts may cause higher
electromagnetic emission or lower electromagnetic immunity.
 Operation of the equipment or system below the minimum amplitude or minimum value stated in
the manual may lead to inaccurate results.

declaration - electromagnetic emission

Emissions test Compliance
RF emissions Group 1
CISPR 11
RF emissions Class B
CISPR 11
Harmonic emissions
Class A

VI-1
 EMC

IEC 61000-3-2
Voltage fluctuations/
Clause 5
flicker emissions
IEC 61000-3-3

declaration - electromagnetic immunity

Immunity test IEC 60601 test level Compliance level
Electrostatic ±8 kV contact ±8 kV contact
discharge (ESD) ±2 kV, ±4 kV, ±8 kV, ±15 ±2 kV, ±4 kV, ±8 kV, ±15 kV air
IEC 61000-4-2 kV air
Electrical fast ± 2 kV for power supply ±2 kV for power supply lines
transient/burst lines
±1 kV for input/output lines
IEC 61000-4-4 ± 1 kV for input/output
lines
Surge ± 0.5kV, ± 1 kV line(s) to ±0.5kV, ±1 kV line(s) to lines
IEC 61000-4-5 lines
±0.5kV, ±1 kV, ±2 kV line(s) to earth
± 0.5kV, ± 1 kV, ± 2 kV
line(s) to earth
Voltage dips, 0 % UT; 0.5 cycle At 0°, 0 % UT; 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°,
short interruptions 45°, 90°, 135°, 180°, 225°, 270°and 315°
and voltage 270°and 315°
variations on 0 % UT; 1 cycle and
power supply 0 % UT; 1 cycle and 70 % UT; 25/30 cycles
input lines 70 % UT; 25/30 cycles Single phase: at 0°
IEC 61000-4-11 Single phase: at 0°

0 % UT; 250/300 cycles

0 % UT; 250/300 cycles
Power frequency 30 A/m 30 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.

declaration - electromagnetic immunity

Immunity test IEC 60601 test Compliance level
level
Conducted RF 3V 3V
IEC 61000-4-6 0.15 MHz to 80 0.15 MHz to 80 MHz
MHz 6 V in ISM bands between 0.15 MHz and 80 MHz
6 V in ISM bands
between 0.15 MHz
and 80 MHz
Radiated RF 3V/m 3V/m
IEC 61000-4-3 80 MHz to 2.7 GHz

VI-2
 EMC

declaration - IMMUNITY to proximity fields from RF wireless communications equipment

Immunity IEC60601 test level Compliance level
test
Test Modulation Maximum Immunity
frequency power level
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.

VI-3
 Appendix VII Abbreviations

Parameter Description
APRV APRV Airway Pressure Release Ventilation
Apnea Tinsp Inspiratory time of Apnea Ventilation
Apnea Vent Apnea Ventilation
ATPD ATPD Ambient Temperature and Pressure Dry
BTPS Body Temperature and Pressure Saturated
Cdyn Dynamic Compliance
CPAP/PSV Continuous Positive Airway Pressure/ Pressure Support Ventilation
Cstat Static Compliance
Cycles Sigh Cycles Sigh
DuoVent Duoble Level Ventilation
EtCO2 End-tidal Carbon Dioxide
Exp% Percent of Expiration Trigger
FiO2 Inspired Oxygen Concentration
Flow Flow
f Breathing Frequency
fapnea Frequency of Apnea Ventilation
fmand Mandatory Frequency
fspn Spontaneous Frequency
fsimv Frequency of SIMV
ftotal Total Breathing Frequency
F-Trig Flow Trigger
I:E Inspiratory Time : Expiratory Time Ratio
Interval Interval
Δint.PEEP Intermittent Positive End-Expiratory Pressure (relative to PEEP)
MV Minute Volume
MVspn Spontaneous Minute Volume
MVleak Leakage Minute Volume
NIF Negative Inspiratory Force
NIV Non-Invasive Ventilation
O2 Oxygen
P0.1 100ms Occlusion Pressure
P-A/C Pressure - Assist/Control Ventilation
Paw Airway Pressure
PEEP Positive End-Expiratory Pressure
Phigh Pressure High
PEEPi Intrinsic PEEP
ΔPinsp Pressure Control Level of Inspiration
PI Perfusion index
Plow Pressure Low

VII-1
 Abbreviations

Pmean Mean Pressure

Ppeak Peak Pressure
Pplat Plateau Pressure
PR Pulse Rate
PRVC Pressure Regulated Volume Control Ventilation
PRVC-SIMV Pressure Regulated Volume Controlled - Synchronized Intermittent Mandatory
Ventilation
PSV-S/T Pressure Support Ventilation-Spontaneous/Timed
P-SIMV Pressure - Synchronized Intermittent Mandatory Ventilation
P-Trig Pressure Trigger
ΔPapnea Pressure of Apnea Ventilation (relative to PEEP/Plow)
ΔPsupp Pressure Support Level(relative to PEEP/Plow)
Ri Inspiration Resistance
Re Expiration Resistance
Sigh Sigh
SIMV Synchronized Intermittent Mandatory Ventilation
slopeCO2 CO2 rising slope.
SpO2 Arterial oxygen saturation from pulse oximetry
STPD Standard temperature and pressure dry
Texp Expiration Time
Thigh Time of High Pressure
Tinsp Inspiration Time
Tlow Time of Low Pressure
Tpause(%) Percent of Inspiratory Pause Time
Tpause(s) Pause Time
Tplat Time of Plat In Inspiratory Period
Tslope Time of Pressure Rising
TV Tidal Volume
TVapnea Tidal Volume of Apnea Ventilation
TVe Expired Tidal Volume
TV/IBW Tidal Volume Per Ideal Body Weight
TVe spn Spontaneous Expired Tidal Volume
TVi Inspired tidal Volume
IBW Ideal Body Weight
Volume Gas Volume
Vtrap Volume of Trapped Gas
V-A/C Volume - Assist/Control Ventilation
V-SIMV Volume - Synchronized Intermittent Mandatory Ventilation
VS Volume Support Ventilation
RCexp Expiratory time constant
RSBI Rapid Shallow Breath Index
WOB Work of Breath
Vdaw Airway dead space.
VDaw/TVe Ratio of airway dead space to tidal volume.
VeCO2 Exhaled CO2 volume.

VII-2
 Abbreviations

ViCO2 Inspired CO2 volume.

Vtalv Alveolar tidal ventilation.
V’alv Alveolar minute ventilation.
V’CO2 CO2 elimination.
HPO High-pressure oxygen
LPO Low-pressure oxygen
Tapnea Apnea time

VII-3
 Appendix VIII The accuracy of SpO2

The accuracy of COMEN SpO2:

Twenty-four adult subjects are included in clinical trial aged from 24 years old to 44 years old (7 males and 17
females, 20 yellows and 4 blacks), with 6 neonates included aged from 1 day to 24 days (5 males and 1
female), there are 30 subjects in total were included in the tests. The table below show SpO2 accuracy for
Comen SpO2 module vs Co-Oximeters(Arms) in a clinical study.

For SAL104 COMEN SpO2:

SpO2 sensor model 70%-100% 90%-100% 80%-90% 70%-80%
040-000312-00 SAL104 2.562% 2.486% 2.482% 2.855%

For SES104 COMEN SpO2:

SpO2 sensor model 70%-100% 90%-100% 80%-90% 70%-80%
040-000730-00 SES104 2.157% 2.329% 2.015% 1.908%

Note
 The two sensors that have been tested in the clinical trial are considered as the representative

VIII-1
 The accuracy of SpO2

of other Comen SpO2 sensors. So the accuracy claimed applies to all Comen SpO2 sensors.

The accuracy of Masimo SpO2:

For M-LNCS DCI MASIMO SpO2
SpO2 sensor model 70%-100% 90%-100% 80%-90% 70%-80%
040-000203-00 M-LNCS DCI 1.90% 1.44% 2.30% 1.84%

Note
 The data above about the accuracy of Masimo SpO2 originated from Masimo’s IFU. Please visit
www.masimo.com for more details.

The accuracy of Nellcor SpO2:

For DS-100A NELLCOR SpO2
SpO2 sensor model 70%-100% 90%-100% 80%-90% 70%-80%
040-000010-00 DS-100A 1.64% 1.16% 1.67% 2.25%

Note
 The data above about the accuracy of Nellcor SpO2 originated from Nellcor’s IFU. Please visit
www.nellcor.com for more details.

VIII-2