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SV70

Ventilator

Operator’s Manual
© 2021 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.

For this Operator’s Manual, the issue date is September, 2021.

Intellectual Property Statement


SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the
intellectual property rights to this Mindray product and this manual. This manual may refer to
information protected by copyright or patents and does not convey any license under the patent
rights or copyright of Mindray, or of others.

Mindray intends to maintain the contents of this manual as confidential information. Disclosure of
the information in this manual in any manner whatsoever without the written permission of Mindray
is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation, translation or
any other derivative work of this manual in any manner whatsoever without the written permission
of Mindray is strictly forbidden.

, and are the trademarks, registered or otherwise, of Mindray


in China and other countries. All other trademarks that appear in this manual are used only for
informational or editorial purposes. They are the property of their respective owners.

Responsibility on the Manufacturer Party


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

All information contained in this manual is believed to be correct. Mindray shall not be liable for
errors contained herein or for incidental or consequential damages in connection with the furnishing,
performance, or use of this manual.

Mindray is responsible for the effects on safety, reliability and performance of this product, only if:

• all installation operations, expansions, changes, modifications and repairs of this product are
conducted by Mindray authorized personnel;
• the electrical installation of the relevant room complies with the applicable national and local
requirements; and
• the product is used in accordance with the instructions for use.

WARNING: It is important for the hospital or organization that employs this


equipment to carry out a reasonable service/maintenance plan.
Neglect of this may result in machine breakdown or personal injury.

NOTE: This equipment must be operated by skilled/trained clinical


professionals.

Operator’s Manual of Ventilator 1


Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or other
charges or liability for direct, indirect or consequential damages or delay resulting from the improper
use or application of the product or the use of parts or accessories not approved by Mindray or
repairs by people other than Mindray authorized personnel.

This warranty shall not extend to:

• Malfunction or damage caused by improper use or man-made failure.


• Malfunction or damage caused by unstable or out-of-range power input.
• Malfunction or damage caused by force majeure such as fire and earthquake.
• Malfunction or damage caused by improper operation or repair by unqualified or unauthorized
service people.
• Malfunction of the instrument or part whose serial number is not legible enough.
• Others not caused by instrument or part itself.

Customer Service Department


Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan,
Address:
Shenzhen 518057, P.R. China
Website: www.mindray.com

E-mail Address: service@mindray.com

Tel: +86 755 81888998

Fax: +86 755 26582680

EC-Representative: Shanghai International Holding Corp. GmbH (Europe)

Address: Eiffestraβe 80, 20537 Hamburg, GERMANY

Tel: 0049-40-2513175

Fax: 0049-40-255726

Notification of Adverse Events


As a health care provider, you may report the occurrence of certain events to SHENZHEN MINDRAY
BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the competent authority of the Member state
in which the user and / or patient is established.

These events, include device-related death and serious injury or illness. In addition, as part of our
Quality Assurance Program, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. requests to
be notified of device failures or malfunctions. This information is required to ensure that SHENZHEN
MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. provides only the highest quality products.

2 Operator’s Manual of Ventilator


Preface
Manual Purpose
This manual contains the instructions necessary to operate the product safely and in accordance with
its function and intended use. Observance of this manual is a prerequisite for proper product
performance and correct operation and ensures patient and operator safety.

This manual is based on the maximum configuration and therefore some contents may not apply to
your product. If you have any question, please contact us.

This manual is an integral part of the product. It should always be kept close to the equipment so that
it can be obtained conveniently when needed.

Intended Audience
This manual is geared for clinical professionals who are expected to have a working knowledge of
medical procedures, practices and terminology as required for monitoring of critically ill patients.

Illustrations
All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or
data displayed on your ventilator.

Conventions
• Italic text is used in this manual to quote the referenced chapters or sections.
• [ ] is used to enclose screen texts.
• → is used to indicate operational procedures.

Password
A password is required to access different menus within the ventilator.

• System menu: 1234

Operator’s Manual of Ventilator 3


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4 Operator’s Manual of Ventilator


Table of Contents

Table of Contents
Intellectual Property Statement.......................................................................................................................................................................................................................1
Responsibility on the Manufacturer Party..................................................................................................................................................................................................1
Warranty..........................................................................................................................................................................................................................................................................2
Exemptions ...................................................................................................................................................................................................................................................................2
Customer Service Department.........................................................................................................................................................................................................................2
Notification of Adverse Events..........................................................................................................................................................................................................................2
Preface..............................................................................................................................................................................................................................................................................3
Table of Contents......................................................................................................................................................................................................................................................5
Safety.................................................................................................................................................................................... 1 - 1
Safety Information .............................................................................................................................................................................................................................................. 1 - 2
WARNING .................................................................................................................................................................................................................................................... 1 - 2
CAUTION...................................................................................................................................................................................................................................................... 1 - 5
NOTE............................................................................................................................................................................................................................................................... 1 - 7
Device Symbols.................................................................................................................................................................................................................................................... 1 - 7
Symbols on the Ventilator/Package/Labeling ..................................................................................................................................................................... 1 - 7
Interface Symbols................................................................................................................................................................................................................................... 1 - 9
The Basics ............................................................................................................................................................................ 2 - 1
Introduction............................................................................................................................................................................................................................................................ 2 - 2
Intended Use............................................................................................................................................................................................................................................. 2 - 2
Product Description.............................................................................................................................................................................................................................. 2 - 2
Product Appearance ......................................................................................................................................................................................................................................... 2 - 4
Front View................................................................................................................................................................................................................................................... 2 - 4
Rear View ..................................................................................................................................................................................................................................................... 2 - 6
Side View ..................................................................................................................................................................................................................................................... 2 - 8
Installations......................................................................................................................................................................... 3 - 1
Install Main Unit.................................................................................................................................................................................................................................................... 3 - 2
Connect Power Supply.................................................................................................................................................................................................................................... 3 - 3
Connect O2 Supply............................................................................................................................................................................................................................................ 3 - 3
Connect High-pressure O2 Supply ............................................................................................................................................................................................. 3 - 4
Connect Low-pressure O2 Supply............................................................................................................................................................................................... 3 - 5
Install Backup Gas Cylinder ........................................................................................................................................................................................................................... 3 - 6
Install IV Pole .......................................................................................................................................................................................................................................................... 3 - 7
Install Support Arm ............................................................................................................................................................................................................................................ 3 - 8
Install Humidifier.................................................................................................................................................................................................................................................. 3 - 9
Install Nebulizer.................................................................................................................................................................................................................................................... 3 - 10
Install Patient Tubing ........................................................................................................................................................................................................................................3 - 10
Install O2 Sensor .................................................................................................................................................................................................................................................. 3 - 12
Install Auxiliary Pressure Monitoring Accessories ........................................................................................................................................................................... 3 - 13
Install O2 Therapy Accessories.................................................................................................................................................................................................................... 3 - 13
Install CO2 Monitoring Accessories ......................................................................................................................................................................................................... 3 - 13
Install SpO2 Monitoring Accessories....................................................................................................................................................................................................... 3 - 13
Interface ............................................................................................................................................................................... 4 - 1
Display Control ..................................................................................................................................................................................................................................................... 4 - 2
Waveforms............................................................................................................................................................................................................................................................... 4 - 3
Measured Values.................................................................................................................................................................................................................................................. 4 - 4
Big Numeric ............................................................................................................................................................................................................................................................ 4 - 5
History ........................................................................................................................................................................................................................................................................ 4 - 5
Graphic Trend........................................................................................................................................................................................................................................... 4 - 6
Tabular Trend............................................................................................................................................................................................................................................ 4 - 7
Setting Trends .......................................................................................................................................................................................................................................... 4 - 8

Operator’s Manual of Ventilator 5


Table of Contents

Event Logbook......................................................................................................................................................................................................................................... 4 - 8
Freeze ......................................................................................................................................................................................................................................................................... 4 - 9
Enter Freeze Status................................................................................................................................................................................................................................ 4 - 9
Exit Freeze Status.................................................................................................................................................................................................................................... 4 - 9
Screenshot............................................................................................................................................................................................................................................................... 4 - 9
Lock Screen............................................................................................................................................................................................................................................................. 4 - 9
System Setup ...................................................................................................................................................................... 5 - 1
Export via USB ....................................................................................................................................................................................................................................................... 5 - 2
Export Screenshot.................................................................................................................................................................................................................................. 5 - 2
Export Data................................................................................................................................................................................................................................................. 5 - 2
Transfer Settings ..................................................................................................................................................................................................................................... 5 - 2
Basic Settings ......................................................................................................................................................................................................................................................... 5 - 3
Set IBW/Height ........................................................................................................................................................................................................................................ 5 - 3
Set Increase O2% During O2 ↑.................................................................................................................................................................................................... 5 - 3
Set O2 Sensor Monitoring................................................................................................................................................................................................................. 5 - 3
Set O2 Supply Type............................................................................................................................................................................................................................... 5 - 4
Interface Settings................................................................................................................................................................................................................................................. 5 - 4
Screen Brightness Adjustment ...................................................................................................................................................................................................... 5 - 4
Key Volume Adjustment.................................................................................................................................................................................................................... 5 - 4
Screen Setup ............................................................................................................................................................................................................................................. 5 - 4
Color Setup ................................................................................................................................................................................................................................................ 5 - 4
System Setup......................................................................................................................................................................................................................................................... 5 - 5
Time and Date Setup ........................................................................................................................................................................................................................... 5 - 5
Language Setup...................................................................................................................................................................................................................................... 5 - 5
Unit Setup ................................................................................................................................................................................................................................................... 5 - 5
Minimum Alarm Volume Setup .................................................................................................................................................................................................... 5 - 5
Change Password .................................................................................................................................................................................................................................. 5 - 6
Set Ventilator Location........................................................................................................................................................................................................................ 5 - 6
Patient Management........................................................................................................................................................................................................................... 5 - 6
Default Value Management............................................................................................................................................................................................................. 5 - 6
Nurse Call Setup...................................................................................................................................................................................................................................... 5 - 7
Network Setup ......................................................................................................................................................................................................................................... 5 - 7
View System Information .................................................................................................................................................................................................................. 5 - 9
View Open Source information..................................................................................................................................................................................................... 5 - 9
Manufacturer Service Setup ......................................................................................................................................................................................................................... 5 - 9
Start Ventilation ................................................................................................................................................................. 6 - 1
Start System............................................................................................................................................................................................................................................................ 6 - 2
Patient Management........................................................................................................................................................................................................................................ 6 - 2
Set Patient Information on the Ventilator............................................................................................................................................................................... 6 - 2
Get Patient Information from ADT Server............................................................................................................................................................................... 6 - 2
Select Mask/ET ...................................................................................................................................................................................................................................................... 6 - 3
Whether to Connect Exhalation Port...................................................................................................................................................................................................... 6 - 3
Ventilation Mode................................................................................................................................................................................................................................................. 6 - 3
Ventilation Mode and Parameter Setup .................................................................................................................................................................................. 6 - 4
Continuous Positive Airway Pressure (CPAP) Ventilation Mode ............................................................................................................................... 6 - 4
Spontaneous/Timed (S/T) Ventilation Mode ........................................................................................................................................................................ 6 - 5
Spontaneous (S) Ventilation Mode ............................................................................................................................................................................................. 6 - 6
Timed (T) Ventilation Mode ............................................................................................................................................................................................................. 6 - 7
Pressure-Assist/Control (P-A/C) Ventilation Mode ............................................................................................................................................................ 6 - 8
Volume Assured Pressure Support (VAPS) Ventilation Mode..................................................................................................................................... 6 - 9
Proportional Pressure Ventilation (PPV) Mode..................................................................................................................................................................... 6 - 10
Spontaneous/Timed Ventilation Plus (S/T+) Ventilation Mode ................................................................................................................................ 6 - 12

6 Operator’s Manual of Ventilator


Table of Contents

O2 Therapy................................................................................................................................................................................................................................................. 6 - 13
Ventilation Additives .........................................................................................................................................................................................................................................6 - 16
Backup Ventilation Mode.................................................................................................................................................................................................................. 6 - 16
Leakage Compensation ..................................................................................................................................................................................................................... 6 - 16
Adaptive EPAP.......................................................................................................................................................................................................................................... 6 - 17
Pressure Relief........................................................................................................................................................................................................................................... 6 - 17
EasySync™ ................................................................................................................................................................................................................................................... 6 - 17
Ramp.............................................................................................................................................................................................................................................................. 6 - 18
Alarm Limit Setup ............................................................................................................................................................................................................................................... 6 - 19
Start Ventilation.................................................................................................................................................................................................................................................... 6 - 19
Ventilation Parameters..................................................................................................................................................................................................................................... 6 - 20
Enter Standby Mode ......................................................................................................................................................................................................................................... 6 - 21
Power off System................................................................................................................................................................................................................................................. 6 - 22
CO2 Monitoring .................................................................................................................................................................. 7 - 1
Overview................................................................................................................................................................................................................................................................... 7 - 2
Prepare for Measurement.............................................................................................................................................................................................................................. 7 - 3
CO2 Setup................................................................................................................................................................................................................................................................ 7 - 4
Set CO2 Monitoring.............................................................................................................................................................................................................................. 7 - 4
Set BTPS Compensation..................................................................................................................................................................................................................... 7 - 4
Set Null for 30s from Zeroing.......................................................................................................................................................................................................... 7 - 5
Set CO2 Unit .............................................................................................................................................................................................................................................. 7 - 5
Influencing Factors of Measurement...................................................................................................................................................................................................... 7 - 5
Troubleshooting .................................................................................................................................................................................................................................................. 7 - 6
Zero the Sensor .................................................................................................................................................................................................................................................... 7 - 6
Calibrate the Sensor .......................................................................................................................................................................................................................................... 7 - 6
SpO2 Monitoring................................................................................................................................................................ 8 - 1
Overview................................................................................................................................................................................................................................................................... 8 - 2
Safety Information .............................................................................................................................................................................................................................................. 8 - 3
Monitoring Steps................................................................................................................................................................................................................................................. 8 - 3
SpO2 Setup ............................................................................................................................................................................................................................................................. 8 - 4
Set SpO2 Monitoring ........................................................................................................................................................................................................................... 8 - 4
Set Sensitivity............................................................................................................................................................................................................................................ 8 - 4
Set Pulse Volume.................................................................................................................................................................................................................................... 8 - 4
Set Sweep Speed.................................................................................................................................................................................................................................... 8 - 4
Influencing Factors of Measurement...................................................................................................................................................................................................... 8 - 4
Special Functions ............................................................................................................................................................... 9 - 1
O2 ↑ .......................................................................................................................................................................................................................................................................... 9 - 2
Auxiliary Pressure................................................................................................................................................................................................................................................. 9 - 2
Connect Auxiliary Pressure Monitoring Accessories ........................................................................................................................................................ 9 - 3
Turn on or off Auxiliary Pressure ................................................................................................................................................................................................... 9 - 3
Zero Auxiliary Pressure........................................................................................................................................................................................................................ 9 - 3
Alarms.................................................................................................................................................................................10 - 1
Introduction......................................................................................................................................................................................................................................................... 10 - 2
Alarm Types ......................................................................................................................................................................................................................................................... 10 - 2
Alarm Priority ...................................................................................................................................................................................................................................................... 10 - 2
Alarm Signals ...................................................................................................................................................................................................................................................... 10 - 2
Alarm Lamps .......................................................................................................................................................................................................................................... 10 - 3
Audible Alarms ..................................................................................................................................................................................................................................... 10 - 3
Alarm Messages ................................................................................................................................................................................................................................... 10 - 3
Flashing Alarm Parameters ........................................................................................................................................................................................................... 10 - 3
Alarm Status Icon ................................................................................................................................................................................................................................ 10 - 3
Set Alarm Volume ............................................................................................................................................................................................................................................ 10 - 4

Operator’s Manual of Ventilator 7


Table of Contents

Set Alarm Limits ................................................................................................................................................................................................................................................ 10 - 4


AUDIO PAUSED ................................................................................................................................................................................................................................................. 10 - 5
Set AUDIO PAUSED............................................................................................................................................................................................................................ 10 - 5
Cancel AUDIO PAUSED.................................................................................................................................................................................................................... 10 - 5
Current Alarm ..................................................................................................................................................................................................................................................... 10 - 5
Recent Alarms .................................................................................................................................................................................................................................................... 10 - 6
ALARM OFF .......................................................................................................................................................................................................................................................... 10 - 6
Alarm Tests........................................................................................................................................................................................................................................................... 10 - 6
Battery in Use......................................................................................................................................................................................................................................... 10 - 6
Loss of Power......................................................................................................................................................................................................................................... 10 - 6
Paw Too High ........................................................................................................................................................................................................................................ 10 - 7
Paw Too Low.......................................................................................................................................................................................................................................... 10 - 7
TVe Too Low........................................................................................................................................................................................................................................... 10 - 7
TVe Too High.......................................................................................................................................................................................................................................... 10 - 7
MVe Too Low ......................................................................................................................................................................................................................................... 10 - 7
MVe Too High........................................................................................................................................................................................................................................ 10 - 7
ftotal Too Low ....................................................................................................................................................................................................................................... 10 - 7
ftotal Too High ...................................................................................................................................................................................................................................... 10 - 7
Apnea ......................................................................................................................................................................................................................................................... 10 - 8
O2 Supply Failure ................................................................................................................................................................................................................................ 10 - 8
FiO2 Too High........................................................................................................................................................................................................................................ 10 - 8
FiO2 Too Low......................................................................................................................................................................................................................................... 10 - 8
EtCO2 Too High.................................................................................................................................................................................................................................... 10 - 8
EtCO2 Too Low..................................................................................................................................................................................................................................... 10 - 8
SpO2 Too High...................................................................................................................................................................................................................................... 10 - 9
SpO2 Too LOW ..................................................................................................................................................................................................................................... 10 - 9
SpO2 Desat.............................................................................................................................................................................................................................................. 10 - 9
PR Too High ............................................................................................................................................................................................................................................ 10 - 9
PR Too LOW ............................................................................................................................................................................................................................................ 10 - 9
Nurse Call .............................................................................................................................................................................................................................................................. 10 - 10
Responses to Alarms ...................................................................................................................................................................................................................................... 10 - 10
Cleaning and Disinfection ..............................................................................................................................................11 - 1
Cleaning and Disinfection Methods..................................................................................................................................................................................................... 11 - 3
Disassemble the Ventilator’s Cleanable and Disinfectable Parts........................................................................................................................................ 11 - 5
HEPA Filter Components and Air Intake Dust Filter....................................................................................................................................................... 11 - 5
Patient Tubing....................................................................................................................................................................................................................................... 11 - 6
Humidifier ................................................................................................................................................................................................................................................ 11 - 7
Maintenance .....................................................................................................................................................................12 - 1
Maintenance Principle .................................................................................................................................................................................................................................. 12 - 2
Maintenance Schedule................................................................................................................................................................................................................................. 12 - 2
Exhalation port Calibration ........................................................................................................................................................................................................................ 12 - 4
Pressure Zeroing............................................................................................................................................................................................................................................... 12 - 4
Oxygen Concentration Calibration....................................................................................................................................................................................................... 12 - 4
CO2 Maintenance ............................................................................................................................................................................................................................................ 12 - 5
CO2 Zeroing ........................................................................................................................................................................................................................................... 12 - 5
CO2 Calibration .................................................................................................................................................................................................................................... 12 - 5
Battery Maintenance...................................................................................................................................................................................................................................... 12 - 6
Guidelines for Battery Use.............................................................................................................................................................................................................. 12 - 6
Optimize Battery Performance ................................................................................................................................................................................................... 12 - 7
Check Battery Performance .......................................................................................................................................................................................................... 12 - 7
Store Batteries ....................................................................................................................................................................................................................................... 12 - 8
Recycle Batteries .................................................................................................................................................................................................................................. 12 - 8

8 Operator’s Manual of Ventilator


Table of Contents

Electrical Safety Inspection......................................................................................................................................................................................................................... 12 - 8


Accessories ........................................................................................................................................................................13 - 1
Accessories List.................................................................................................................................................................................................................................................. 13 - 2
Theory of Operation ..........................................................................................................................................................A - 1
Pneumatic Circuit Principle...........................................................................................................................................................................................................................A - 2
Pneumatic Circuit Diagram..............................................................................................................................................................................................................A - 2
Parts List .......................................................................................................................................................................................................................................................A - 2
Principle Description............................................................................................................................................................................................................................A - 3
Electrical System ..................................................................................................................................................................................................................................................A - 3
Electrical System Structure Diagram..........................................................................................................................................................................................A - 3
Parts List .......................................................................................................................................................................................................................................................A - 4
Product Specifications ...................................................................................................................................................... B - 1
Safety Specifications..........................................................................................................................................................................................................................................B - 2
Environment Specifications..........................................................................................................................................................................................................................B - 2
Power Supply Specifications........................................................................................................................................................................................................................B - 3
Physical Specifications .....................................................................................................................................................................................................................................B - 3
Pneumatic System Specifications.............................................................................................................................................................................................................B - 5
Ventilator Specifications .................................................................................................................................................................................................................................B - 6
Ventilator Accuracy............................................................................................................................................................................................................................................B - 7
Alarms.........................................................................................................................................................................................................................................................................B - 9
Settable Alarms........................................................................................................................................................................................................................................B - 9
Built-in Alarms ..........................................................................................................................................................................................................................................B - 9
Special Function ..................................................................................................................................................................................................................................................B - 9
CO2 Module ...........................................................................................................................................................................................................................................................B - 10
SpO2 Module.........................................................................................................................................................................................................................................................B - 10
EMC .......................................................................................................................................................................................C - 1
EMC..............................................................................................................................................................................................................................................................................C - 2
Radio Regulatory Compliance.....................................................................................................................................................................................................................C - 6
WiFi Parameters..........................................................................................................................................................................................................................................................6
Alarm Messages................................................................................................................................................................. D - 1
Physiological Alarms ........................................................................................................................................................................................................................................ D - 2
Technical Alarms................................................................................................................................................................................................................................................. D - 5
Factory Defaults ................................................................................................................................................................. E - 1
Ventilation Parameters..................................................................................................................................................................................................................................... E - 2
Setup........................................................................................................................................................................................................................................................................... E - 2
Alarms......................................................................................................................................................................................................................................................................... E - 3
History ........................................................................................................................................................................................................................................................................ E - 4
Other ........................................................................................................................................................................................................................................................................... E - 4
Abbreviations, Symbols and Measuring Units ............................................................................................................. F - 1
Abbreviations ........................................................................................................................................................................................................................................................ F - 2
Symbols..................................................................................................................................................................................................................................................................... F - 3
Measuring Unit ..................................................................................................................................................................................................................................................... F - 4

Operator’s Manual of Ventilator 9


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Operator’s Manual of Ventilator 10


1.0 Safety

Safety Information....................................................................................................................................................................................1-2
Device Symbols .........................................................................................................................................................................................1-7

Operator’s Manual of Ventilator 1-1


Safety Information Safety

1.1 Safety Information


WARNING — Indicates a potential hazard or unsafe practice that, if not avoided, could result in
death, serious injury or property damage.

CAUTION — Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor
personal injury, product fault, damage or property loss.

NOTE — Highlights important precautions and provides descriptions or explanations for better use
of this product.

1.1.1 WARNING
WARNING: The ventilator must be operated and used by authorized and well-
trained medical personnel only. Unauthorized or untrained personnel
shall never be allowed to perform any operations. The ventilator must
be operated strictly following the Operator's Manual.

WARNING: The equipment, cables and accessories must be inspected before use to
guarantee their proper and safe operation.

WARNING: To avoid the risk of electric shock, this equipment must be connected to
a properly installed power outlet with protective earth terminal only.
Do not use the power outlet if it is not connected to a protective earth
terminal. Use the lithium ion batteries temporarily to supply power to
the equipment.

WARNING: Use external power source (AC power) before the batteries are
depleted.

WARNING: Do not use the equipment in the presence of flammable or explosive


materials to prevent fire or explosion. When O2 is used, keep the
ventilator away from any fire sources.

WARNING: Do not place the ventilator adjacent to any barrier, which may prevent
cold air from flowing, resulting in equipment overheat.

WARNING: Do not open the case of the equipment, as you may suffer an electric
shock. All servicing and upgrading operations of the equipment must
be carried out by the service personnel trained and authorized by the
manufacturer only.

WARNING: Set alarm volume and alarm limits based on the patient’s actual
condition. Do not rely exclusively on the audible alarm system for
patient monitoring. Adjustment of alarm volume to a low level may
result in a hazard to the patient. Always keep an eye on the patient's
actual clinical situations.

WARNING: The physiological parameters and alarm messages displayed on the


screen of the equipment are for clinicians' reference only and cannot
directly act as a basis for clinical treatment.

WARNING: Observe local applicable laws and regulations or hospital regulations


on waste treatment to dispose of packaging materials. And keep the
packaging material out of children’s reach.

WARNING: All staff should be aware that disassembling or cleaning some parts of
the ventilator can cause risk of infection.

WARNING: The service mode can only be accessed when the equipment is
disconnected from the patient.

1-2 Operator’s Manual of Ventilator


Safety Safety Information

WARNING: Positive pressure ventilation may be accompanied by some side effects


such as barotrauma, hypoventilation, hyperventilation, etc.

WARNING: Using the ventilator in the vicinity of high frequency electrosurgery


equipment, defibrillators or short-wave therapy equipment may impair
normal functioning of the ventilator and endanger the patient.

WARNING: Do not use antistatic or conductive masks or patient tubings when high
frequency surgical equipment is in use as this may cause burns.

WARNING: Do not use the ventilator in the hyperbaric chamber.

WARNING: If the internal monitoring system of the equipment fails, an alternative


plan must be in place to ensure adequate level of monitoring. The
operator of the ventilator must be responsible for the patient’s proper
ventilation and safety under all circumstances.

WARNING: As required by relevant laws and regulations, oxygen concentration


should be monitored when the equipment is used on the patient. If the
ventilator is not configured with such monitoring function or this
function is turned off, please use a monitor which complies with the
requirements of ISO 80601-2-55 for oxygen concentration monitoring.

WARNING: All analog or digital devices connected to this system must be certified
to specified standards (such as IEC 60950-1 for data processing
equipment and IEC 60601-1 for medical electrical equipment). All
configurations shall comply with the valid version of IEC 60601-1. The
personnel connecting the optional equipment to the I/O signal port
shall be responsible for medical system configuration and system
compliance with IEC 60601-1 as well.

WARNING: Do not touch the patient when connecting the peripheral equipment
via the I/O signal ports or replacing the O2 sensor, to prevent patient
leakage current from exceeding the requirements specified by the
standard.

WARNING: This equipment is not suitable for use in an MRI environment.

WARNING: When the ventilator's gas supply input system fails or has faults, please
contact the manufacturer immediately for service by specified
personnel.

WARNING: The ventilator shall not be used with helium or mixtures with helium.

WARNING: Remove the support arm and IV pole before moving the ventilator to
prevent the ventilator from tipping.

WARNING: The oxygen and air gas mixer of the ventilator contains no grease and
thus no de-grease process is needed. Do not use lubricants that contain
oil or grease, and rubber hose assembly should not be contaminated
with grease. Oil- or grease-containing lubricants may burn up or
explode when exposed to a high O2 concentration.

WARNING: The maximum pressure of hose is 1.4 MPa@21ºC and please check
whether its gas supply pressure meets hose requirements before
usage.

WARNING: Hose connectors adopt standardized gas terminal connector with gas
nature. Different types of gas and gas with different pressures shall not
be exchanged with each other.

WARNING: Hoses may be aging quickly by long-term exposure to acidity, alkalinity


or ultraviolet rays.

Operator’s Manual of Ventilator 1-3


Safety Information Safety

WARNING: Do not cascade two or more hose assemblies together.

WARNING: The ventilator arm could bear 1kg maximally and do not hang over 1kg
goods.

WARNING: After the ventilator is installed or the main control board is replaced,
please set the altitude again. After the altitude setting is modified,
please perform flow calibration (factory).

WARNING: When disconnecting fast connectors, please operate by two hands to


prevent potential injury caused by sudden pressure release.

WARNING: Do not block the air intake on the rear of the ventilator.

WARNING: To prevent interrupted operation of the ventilator due to


electromagnetic interference, avoid using the ventilator adjacent to or
stacking with other devices. If adjacent or stacked use is necessary,
verify the ventilator’s normal operation in the configuration to be used.

WARNING: Ensure that the ventilator is securely fixed to the trolley or placed on a
safe and steady surface to prevent personal injury and equipment
damage.

WARNING: Move the ventilator carefully around or through obstacles (such as


thresholds) to prevent it from tipping or causing damage.

WARNING: Keep the brake down when the ventilator is moved into place to
prevent unexpected movement of and damage to the equipment.

WARNING: Avoid the use of polluted air. When the equipment uses air as gas
source for ventilation, if the air is polluted, harmful substance may
enter the patient tubing.

WARNING: When a [Technical Error **] alarm is triggered, remove the equipment,
record the error code and contact the Customer Service Department
immediately to prevent damage to the patient caused by equipment
faults.

WARNING: Do not splash liquid onto the ventilator to prevent ventilator faults.

WARNING: Blower fan could cause gas to be heated. To reduce the temperature of
gas inside the patient tubing and prevent patient injury accordingly,
ensure that the length of patient tubing from the humidifier to patient-
end port is greater than 1.2 meters.

WARNING: The internal battery is to be used temporarily if the integrity of the


protective earth conductor or the protective grounding system in the
installation is in doubt.

WARNING: Nebulizers or humidifiers may increase the resistance of breathing


system filters. For this reason, the operator shall keep an eye on the
filter for increased resistance and blockage.

WARNING: Nebulization may impact the ventilation accuracy of the ventilator.

WARNING: Check whether the alarm limits have been appropriately set before
starting ventilation.

WARNING: Always connect the equipment to an easily accessible power socket if


external power supply is used, so that the power plug can be
disconnected conveniently and quickly in the event of a fault.

WARNING: No modification of this equipment is allowed.

1-4 Operator’s Manual of Ventilator


Safety Safety Information

WARNING: Stop using the ventilator immediately and contact the Customer
Service Department when the buzzer sounds an alarm.

WARNING: When ventilator is connected to a patient, do not remove or replace


fuse, or perform any other maintenance tasks. Such operations must be
performed when the patient is not using the ventilator.

WARNING: Ensure that the AC power cord is disconnected before removing or


replacing the fuse.

WARNING: Use the power cord provided by the manufacturer to prevent power
failure or poor contact.

WARNING: Hazard can exist if different alarm presets are used for the same or
similar equipment in any single area. Please read the manual to confirm
alarm presets for the ventilator before use.

WARNING: This ventilator is a high flow device and should only be connected to a
pipeline installation that allows for the indicated required flow at the
terminal outlets, in order to avoid exceeding the pipeline flow
capabilities and to minimize the risk that the ventilator interferes with
adjacent equipment operation.

WARNING: Under the ambient temperature of 40ºC. the maximum temperature on


the surface of breathing mask may exceed 41ºC but does not exceed
43ºC.

1.1.2 CAUTION
CAUTION: The ventilator must be inspected and serviced regularly by trained
service personnel.

CAUTION: Always prepare a respirator as a backup to ensure patient safety.

CAUTION: Always have a dedicated person attend and monitor the operations on
the equipment once the ventilator is connected to the patient.

CAUTION: Use only the accessories specified in this manual to ensure patient
safety.

CAUTION: Dispose of the equipment and its accessories that approach the end of
service life in compliance with applicable local laws and regulations or
hospital regulations.

CAUTION: Electromagnetic field may affect the equipment performance.


Therefore, other devices used in the vicinity of the equipment must
meet corresponding EMC requirements. Mobile phone, X-ray or MRI
devices are possible sources of interference as they may emit higher
levels of electromagnetic radiation.

CAUTION: This system is capable of operating properly at the interference levels


indicated in this manual. Higher levels of interference may trigger
alarms and even stop mechanical ventilation. Please keep the
equipment away from high-intensity electric fields which may cause
the system to issue false alarms.

CAUTION: Ensure that the voltage and frequency of the power supply fall into the
specified ranges on the equipment's label or in this manual before
connecting the equipment to a power supply.

Operator’s Manual of Ventilator 1-5


Safety Information Safety

CAUTION: Always install or transfer the equipment carefully to prevent the it from
fall, collision, violent vibration or other damage from external
mechanical force.

CAUTION: Check whether the reusable patient tubing is damaged or leaky before
use. If so, do not use it.

CAUTION: Disconnect the power plug to electrically isolate the ventilator tubings
from all electrodes of the input power. Do not position the Ventilator so
that it is difficult to operate the plug.

CAUTION: To minimize the risk of fire, do not use the gas supply hose assemblies
that are worn or contaminated with combustible materials (such as
grease or oil).

CAUTION: Clinicians are responsible for ensuring that all ventilator settings are
appropriate.

CAUTION: Ensure that the ventilator is set up for appropriate patient type with the
proper patient tubing to prevent possible patient injury.

CAUTION: Perform pressure zeroing before use of the ventilator, or when the
measured values have deviations.

CAUTION: Ensure that the ventilator's ventilation parameters have been properly
set before starting ventilation to prevent patient injury.

CAUTION: To ensure the accuracy of oxygen concentration monitoring, replace an


exhausted O2 cell as soon as possible or use an external monitor that
complies with ISO 80601-2-55.

CAUTION: Do not force open the O2 cell or throw it into fire to reduce the risk of
explosion.

CAUTION: When ventilating with a mask, avoid high airway pressure, which may
lead to gastric distension.

CAUTION: In non-invasive ventilation, Ppeak > 33 cmH2O may increase the risk


of gastric insufflation. When ventilating at such a pressure, please
consider using an invasive ventilation mode.

CAUTION: Use only hoses that have been approved to serve medical purposes and
for connection with oxygen supplies and ventilators to reduce the risk
of fire.

CAUTION: Ensure the ventilation at the rear side of the ventilator to reduce the
risk of fire.

CAUTION: Switch off the oxygen supply when the ventilator is not in a ventilating
status to reduce the risk of fire.

CAUTION: Avoid storing the ventilator in an environment that is higher than 50°C
in temperature for a long time. Such environment may damage or
shorten the battery lives of internal battery and O2 cell.

CAUTION: Use the original packaging materials to ship the ventilator.

CAUTION: Use only the specified fuses or the fuses of the same type, rated
voltage, and rated current with the current fuses to prevent the risk of
fire. Contact the Customer Service Department when it is necessary to
replace the fuse.

CAUTION: The ventilator is applicable to the patient environment.

1-6 Operator’s Manual of Ventilator


Safety Device Symbols

CAUTION: Additional multi-hole sockets or extension cords shall not be


connected to the system.

CAUTION: Before moving the ventilator, ensure that the casters and brakes can
work properly, and the main unit is locked on the trolley.

CAUTION: Please use dry and clean medical oxygen as gas supply. Moisture in the
gas supply may lead to equipment faults.

1.1.3 NOTE
NOTE: Put the ventilator and its components in a location that facilitates
observation, operation and maintenance.

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

NOTE: The software of the equipment was developed in compliance with the
IEC 62034, with potential risks from program errors minimized.

NOTE: This manual describes the product for the purpose of fully covering its
functions and configuration options, and the product you have
purchased may not support part of these functions or configuration
options.

NOTE: The ventilator returns to normal in 10 seconds after defibrillation.

1.2 Device Symbols


1.2.1 Symbols on the Ventilator/Package/Labeling

SYMBOL DESCRIPTION SYMBOL DESCRIPTION

Caution! WARNING

Fuse Equipotentiality

Protective earth
Stand-by
(ground)

AC power supply Internal batteries

VGA output connector USB connector

RS-232 connector Network connector

Oxygen supply
Nurse call connector
connector

Operator’s Manual of Ventilator 1-7


Device Symbols Safety

Auxiliary pressure Proximal pressure


Paux sampling port monitoring port

Oxygen sensor
Ventilator gas outlet
connector

Temperature limitation Humidity limitation

Atmospheric pressure
Keep dry
limitation

Fragile, handle with


This way up
care

Stacking limit by
Recyclable
number: n = 5

Manufacturer Date of manufacture

European community
Serial number
representative

Degree of protection
IP21 against harmful ingress Inspiration connector
of water

Defibrillation-proof type
Pushing prohibited
BF applied part

Refer to the operator's


Medical Device
manual

The following definition of the WEEE label applies to EU member states only.
This symbol indicates that this product should not be treated as household
E

waste. By ensuring that this product is disposed of correctly, you will help
prevent bringing potential negative consequences to the environment and
human health. For more detailed information with regard to returning and
recycling this product, please consult the distributor from whom you purchased
it.
* For system products, this label may be attached to the main unit only.

This product is provided with a CE marking in accordance with the regulations


stated in Regulation (EU) 2017/745 or the Council Directive 93/42/EEC
concerning Medical Devices. The number adjacent to the CE marking (0123) is
the number of the EU-notified body certified for meeting the requirements of
the Regulation.

1-8 Operator’s Manual of Ventilator


Safety Device Symbols

1.2.2 Interface Symbols

SYMBOL DESCRIPTION SYMBOL DESCRIPTION

Patient settings Face mask/Nasal mask

ET/Trach tube History

USB connected USB disconnected

Freeze Screenshot

Blower needs to be
Blower
maintained

Inspiratory trigger Setup

AUDIO PAUSED Alarm limits off

Inactivated alarms Number of alarms

Brightness: brighter Brightness: darker

Volume: higher Volume: lower

Volume off Night mode

Day mode

Operator’s Manual of Ventilator 1-9


Device Symbols Safety

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1 - 10 Operator’s Manual of Ventilator


2.0 The Basics

Introduction .................................................................................................................................................................................................2-2
Product Appearance...............................................................................................................................................................................2-4

Operator’s Manual of Ventilator 2-1


Introduction The Basics

2.1 Introduction
2.1.1 Intended Use
2.1.1.1 Intended Purpose Statement
The ventilator is intended for providing ventilation assistance and breathing support for patients.

2.1.1.2 Intended Users


The ventilator must only be operated and used by authorized medical personnel well trained in the
use of this product. It must be operated strictly following the Operator's Manual.

2.1.1.3 Intended Patient Population


The ventilator can be used in adult and pediatric patients.

2.1.1.4 Intended Medical Conditions


For prolonged periods of ventilation and respiratory support for patients with apnea or respiratory
failure, patients are fully dependent on or partly dependent on such equipment. It is usually used in
the professional healthcare facility.

2.1.1.5 Contraindications
There is no absolute contraindication for this product. For some special diseases, however, some
necessary treatments shall be taken for ventilator mechanical ventilation, or special ventilation
modes shall be adopted to prevent possible patient injury.

2.1.1.6 Side-effects
None.

WARNING: According to the conclusion of clinical evaluation and residual risk


evaluation, for the intended patients, there is no known side effects
that can occur during or after the use of the medical device. And there is
no need for the operator to make extra preparations. Thus, no residual
risk associated with using the medical device should be disclosed.

2.1.2 Product Description


The ventilator consists of a main unit (including the pneumatic circuit, the electronic system and the
mechanical structure) and a trolley.

The ventilator is applicable to the patient environment. Connect the patient to the ventilator via the
patient tubing. Applied parts of the ventilator include the SpO2 module accessories, CO2 module
accessories, auxiliary pressure monitoring accessories, patient tubings and masks.

The ventilator provides the following common functions:

2-2 Operator’s Manual of Ventilator


The Basics Introduction

• Continuous positive airway pressure (CPAP) ventilation


• Spontaneous/timed (S/T) ventilation
• Spontaneous (S) ventilation
• Timed (T) ventilation
• Pressure-assist/control (P-A/C) ventilation
• Volume assured pressure support (VAPS) ventilation
• Proportional pressure (PPV) ventilation
• Spontaneous/timed (S/T+) ventilation plus
• O2 therapy
• O2 ↑
• CO2 monitoring
• SpO2 monitoring
• Auxiliary pressure monitoring

Operator’s Manual of Ventilator 2-3


Product Appearance The Basics

2.2 Product Appearance


2.2.1 Front View

10
2 11

3 12

13

FIGURE 2-1 Front View

NO. COMPONENT DESCRIPTION


1 Support arm Hangs the patient tubing.
2 Mask /
3 Exhalation port /
4 Patient tubing /
5 Proximal pressure Monitors pressure.
monitoring sampling
line

2-4 Operator’s Manual of Ventilator


The Basics Product Appearance

NO. COMPONENT DESCRIPTION


6 Watertrap of the patient Collects condensed water in the patient tubing.
tubing
7 Caster and brake The ventilator has four casters and all casters have
brakes.
8 IV pole /
9 Display /
10 Bacteria filter /
11 Proximal pressure /
monitoring port
12 Bacteria filter /
13 Humidifier /

TABLE 2-1 Components List of Front View

Operator’s Manual of Ventilator 2-5


Product Appearance The Basics

2.2.2 Rear View

5
6
7

1 8
2

3 9
4 10
11

FIGURE 2-2 Rear View

NO. COMPONENT DESCRIPTION


1 External display Outputs video signals with the same contents to the
device connector primary display and connects to the external display
device.
2 Air inlet baffle /
3 Low-pressure oxygen Connects to low-pressure O2 supply.
inlet
4 High-pressure oxygen Connects to high-pressure O2 supply.
inlet

2-6 Operator’s Manual of Ventilator


The Basics Product Appearance

NO. COMPONENT DESCRIPTION


5 USB connector • Used for ventilation data export and device running
data import and export.
• Provides power to the electronic nebulizer.
• Upgrades the software for ventilator.
• Connects the mouse.
6 Network connector Connects with a PC to perform software upgrading.
7 RS-232 connector Connects to the external medical equipment to realize
the communication between the ventilator and external
equipment.
8 Nurse call connector Connects to the hospital’s nurse call system and outputs
nurse call signals when an alarm occurs.
9 AC power receptacle Connects the external AC power and provides power for
the ventilator.
10 Equipotential stud / Eliminates the ground potential difference between
lug different equipments to ensure safety.
11 Trolley handle /

TABLE 2-2 Components List of Rear View

Operator’s Manual of Ventilator 2-7


Product Appearance The Basics

2.2.3 Side View

1 4
5
2

FIGURE 2-3 Side View

NO. COMPONENT DESCRIPTION


1 Watertrap connector Connects the CO2 watertrap and sampling line to provide
of CO2 module CO2 monitoring function.
2 Gas outlet /
3 Backup gas cylinder /
4 Auxiliary pressure Connects the auxiliary pressure sampling line to monitor
monitoring port the auxiliary pressure.
5 SpO2 cable Connects the SpO2 cable and sensor to provide the SpO2
connector monitoring function.

TABLE 2-3 Components List of Side View

2-8 Operator’s Manual of Ventilator


3.0 Installations

Install Main Unit .........................................................................................................................................................................................3-2


Connect Power Supply .........................................................................................................................................................................3-3
Connect O2 Supply .................................................................................................................................................................................3-3
Install Backup Gas Cylinder.................................................................................................................................................................3-6
Install IV Pole................................................................................................................................................................................................3-7
Install Support Arm..................................................................................................................................................................................3-8
Install Humidifier .......................................................................................................................................................................................3-9
Install Nebulizer ...................................................................................................................................................................................... 3-10
Install Patient Tubing........................................................................................................................................................................... 3-10
Install O2 Sensor..................................................................................................................................................................................... 3-12
Install Auxiliary Pressure Monitoring Accessories.............................................................................................................. 3-13
Install O2 Therapy Accessories ...................................................................................................................................................... 3-13
Install CO2 Monitoring Accessories............................................................................................................................................ 3-13
Install SpO2 Monitoring Accessories ......................................................................................................................................... 3-13

Operator’s Manual of Ventilator 3-1


Install Main Unit Installations

WARNING: Do not use antistatic or conductive nasal/facial masks or patient


tubings when high frequency surgical equipment is in use as this may
cause burns.

WARNING: Adding accessories or other components to the breathing system of the


ventilator can increase system inspiratory and expiratory resistance.

3.1 Install Main Unit

FIGURE 3-1 Install Main Unit

A. Main unit
B. Unlock key of the trolley
Installation steps:

Place the main unit securely on the trolley, with the main unit aligned to locating pins.

To remove the main unit off the trolley, press the unlock key of the trolley and then lift up the main
unit with both hands.

3-2 Operator’s Manual of Ventilator


Installations Connect Power Supply

3.2 Connect Power Supply

FIGURE 3-2 Connect to AC Power Supply

A. Anti-unplugging hook of power plug


B. AC power socket
C. AC power cord
Installation steps:

1. Turn the anti-unplugging hook of power to the right-hand side.


2. Insert the AC power cord into the AC power socket.
3. Put back anti-unplugging hook of power to clamp the power cord in place.

3.3 Connect O2 Supply


This ventilator provides high-pressure and low-pressure O2 supply connectors.

WARNING: Do not connect the high-pressure and low-pressure O2 supplies at the


same time.

WARNING: Inspect the O2 supply connector carefully and ensure that there is no
leakage. High leakage may result in the oxygen concentration around
the equipment higher than the normal atmospheric level to create an
oxygen-enriched environment that contains potential hazards.

WARNING: Place the O2 supply hose carefully and avoid its exposure to the
environment in which possible damage to the O2 supply hose is easily
caused by cut or heating.

WARNING: To reduce the risk of fire, do not use a low-pressure O2 supply that
delivers a flow greater than 15 L/min.

WARNING: At 280 kPa, 10 s of weighting average input flow at the high-pressure


O2 inlet is no more than 120 L/min. Ensure the high-pressure O2 supply
is sufficient so as not to affect the operation of equipment.

Operator’s Manual of Ventilator 3-3


Connect O2 Supply Installations

CAUTION: Do not use the humidifier and oxygen generator together when the
oxygen generator is used as a gas supply of ventilator. If the oxygen
generator is equipped with a humidifier, drain the water away from the
humidifier or remove the humidifier before using the ventilator.

CAUTION: The setting of oxygen concentration is invalid when using the low-
pressure O2 supply. To prevent possible patient injury, use the low-
pressure O2 supply only when it can provide sufficient oxygen.

CAUTION: Before starting ventilation, ensure that the oxygen supply is correctly
set. Set the high-pressure oxygen or low-pressure oxygen according to
the actual situation. Refer to (page 5-4) 5.2.4 “Set O2 Supply Type”to
read the setting method.

CAUTION: To prevent possible patient injury, ensure that an emergency backup


O2 supply (such as a gas cylinder) is available in case the low-pressure
O2 supply fails.

CAUTION: The low-pressure oxygen hose assembly shall comply with the
requirements of ISO 5359.

3.3.1 Connect High-pressure O2 Supply

FIGURE 3-3 Connect High-Pressure O2 Supply

A. High-pressure O2 supply connector


B. High-pressure O2 supply hose and fitting
When the ventilator is connected to a high-pressure O2 supply, the gas supply pressure is 280~650
kPa in normal working condition. If gas supply pressure is less than 280 kPa, it will affect the
performance of the ventilator and even stop ventilation.

Connect the high-pressure O2 supply as follows.

1. Check if the sealing ring at the gas supply connection is intact before connecting the gas supply
hose. If the sealing ring is damaged, do not use the hose. Replace the sealing ring to prevent
leakage.

3-4 Operator’s Manual of Ventilator


Installations Connect O2 Supply

2. Insert the connector into the high-pressure O2 supply inlet on the rear of the ventilator.
3. Ensure that the gas supply hose is properly connected to the gas supply inlet and tighten the
hose nut by hand.

3.3.2 Connect Low-pressure O2 Supply

FIGURE 3-4 Connect Low-Pressure O2 Supply

A. Low-pressure O2 supply connector


B. Low-pressure O2 supply hose
When the ventilator is connected to a low-pressure O2 supply, the flow of low-pressure O2 supply
cannot exceed 15 L/min. To reduce the risk of fire, do not use a low-pressure O2 supply that delivers a
flow greater than 15 L/min.

To connect the low-pressure O2 supply, align the low-pressure O2 supply hose with and insert it into
the low-pressure O2 supply connector. When a click is heard, it indicates that the gas supply hose is
inserted in place. Depress the metal dome on the low-pressure O2 supply connector to remove the
gas supply hose.

Operator’s Manual of Ventilator 3-5


Install Backup Gas Cylinder Installations

3.4 Install Backup Gas Cylinder


CAUTION: Ensure that the backup gas cylinder is equipped with a pressure relief
valve.

FIGURE 3-5 Install Backup Gas Cylinder

A. Backup gas cylinder


B. Cylinder fixing buckle
C. Trolley base
Installation steps:

1. Place the backup gas cylinder onto the trolley base.


2. Fix the gas cylinder via cylinder fixing buckle.

3-6 Operator’s Manual of Ventilator


Installations Install IV Pole

3.5 Install IV Pole


NOTE: The maximum load of the IV pole is 1 Kg.

FIGURE 3-6 Install IV Pole

A. IV pole
B. Locking nut
Installation steps:

Align the IV pole to the installing hole and tighten the locking nut.

Operator’s Manual of Ventilator 3-7


Install Support Arm Installations

3.6 Install Support Arm


WARNING: To prevent unexpected injury to patients, check the support arm joints
and the connection security as necessary.

NOTE: The maximum load of the support arm is 1 kg.

E
D

C F

G
B

FIGURE 3-7 Install Support Arm

A. Support arm joint


B. Support rod
C. Support arm joint
D. Support rod
E. Support arm joint
F. Support rod
G. Tube hook
H. Locking nut
Installation steps:

3-8 Operator’s Manual of Ventilator


Installations Install Humidifier

1. Align the support arm to the installing hole and tighten the locking nut.
2. Adjust the support arm.
a. Loosen the handle on Joint A, C or E of the support arm.
b. Adjust the support rod to the desired position and tighten the handle on the joint.
3. Hang the patient tubing on the tube hook.

3.7 Install Humidifier


WARNING: To prevent possible patient injury and equipment damage, do not turn
on the humidifier until the ventilator has started and been calibrated.

WARNING: To prevent possible patient injury and equipment damage, ensure the
humidifier is set to appropriate temperature and humidity.

NOTE: The humidifier shall comply with the requirements of ISO 80601-2-74.
Refer to the humidifier accompanying directions for use to install and
use the humidifier. The humidifier assembly and its installation steps
described in this section are only for reference.

C
A
D

FIGURE 3-8 Install Humidifier

Operator’s Manual of Ventilator 3-9


Install Nebulizer Installations

A. Humidifier mounting plate


B. Humidifier
C. Screw
D. Fixing seat of humidifier bracket
Installation steps:

1. Align the humidifier to the fixing seat of the humidifier bracket and slide the humidifier in.
2. Tighten the screws.

3.8 Install Nebulizer


WARNING: Install the specified nebulizer. Refer to the nebulizer accompanying
directions for use to install and use the nebulizer.

WARNING: Keep the electronic nebulizer upright while attaching to the patient
tubing. This orientation helps prevent patient secretions and
condensate from contaminating the aerosol generator of the nebulizer
and ensures proper nebulization.

WARNING: Pay attention to the connection of the nebulizer during operation in


case of interruption of nebulization.

CAUTION: Remove the nebulizer after completing nebulization, otherwise


ventilation may be affected.

CAUTION: The remaining nebulized drug will affect the ambient air.

NOTE: To prevent the exhalation port from sticking due to nebulized


medications, use only medications approved for nebulization, regularly
check and clean or replace the exhalation port.

NOTE: Do not use a Heat & Moisture Exchange (HME) in the patient tubing
during nebulization.

NOTE: Nebulized medications can increase flow resistance or cause occlusion


of the expiratory filter. Check the filter regularly. Replace it if the
expiratory resistance increases.

NOTE: Connecting the nebulizer between the patient connector and the
endotracheal tube increases dead space ventilation.

3.9 Install Patient Tubing


WARNING: To minimize the risk of bacterial contamination or physical damage,
remove and install the bacterial filter with care.

WARNING: To prevent patient or ventilator contamination, always use a bacteria


filter between the ventilator and the patient inspiratory limb.

CAUTION: The patient tubing shall comply with the requirements of ISO 5367.

CAUTION: The bacteria filters shall comply with the requirements of ISO 23328-1
and ISO 23328-2.

CAUTION: The Heat & Moisture Exchange (HME) shall comply with the
requirements of ISO 9360-1 and ISO 9360-2.

3 - 10 Operator’s Manual of Ventilator


Installations Install Patient Tubing

F
A G

B H

FIGURE 3-9 Install Patient Tubing

A. Mask
B. Exhalation port
C. Patient tubing
D. Proximal pressure monitoring sampling line
E. Watertrap
F. Bacteria filter
G. Proximal pressure monitoring port
H. Proximal filter
Installation steps:

1. Install the bacteria filter onto the inspiratory port of the ventilator.

Operator’s Manual of Ventilator 3 - 11


Install O2 Sensor Installations

2. Connect the bacteria filter to the humidifier inlet via the patient tubing.
3. Connect the humidifier outlet to the watertrap via the patient tubing.
4.
• If the oro-nasal mask (non-vented) or the ET/Trach tube is used, the exhalation port is
needed. Connect the watertrap to the exhalation port via the tubing, then connect the
exhalation port and mask or ET/Trach tube.
• If the oro-nasal mask (vented) or total face/nasal mask is used:
• If the exhalation port is not used, connect the watertrap to the face/nasal mask via the tubing.
• If the exhalation port is used, connect the watertrap to the exhalation port via the tubing, then
connect the exhalation port to the face/nasal mask.
5. Connect the proximal pressure monitoring sampling line to the proximal pressure monitoring
port.
6.
• If the exhalation port is used, connect the proximal pressure monitoring sampling line to the
exhalation port.
• If the exhalation port is not used, connect the proximal pressure monitoring sampling line to
the face/nasal mask.
7. Place the patient tubing onto the support arm hook.

3.10 Install O2 Sensor


The O2 sensor serves to monitor the O2% of the supplied gas. The O2 cell is a kind of consumable with
a service life of around one year and should be replaced on a regular basis. It monitors O2% by
measuring the partial pressure of oxygen. Contact the Customer Service Department in event of
exceptional O2% monitored for O2% calibration and functional tests or replacement of the O2 sensor.

CAUTION: To reduce the risk of explosion, do not burn the O2 cell or force it open.

NOTE: The service life of the O2 cell is about one year in normal use at ICU. The
service life of O2 cell is an approximate specification only. The actual
service life depends on the operating environment. Operation at higher
temperatures or higher oxygen concentrations shortens the life.

NOTE: Handle and dispose of the O2 cell in accordance with related biohazard
regulations. Do not burn it.

NOTE: The O2% measurement accuracy drift shall meet the requirements of
the ISO 80601-2-55.

NOTE: Periodical pressure that increases to 10 kPa (100 cmH2O) does not
impact the monitoring accuracy of O2%.

3 - 12 Operator’s Manual of Ventilator


Installations Install Auxiliary Pressure Monitoring Accessories

A
D
E
B

FIGURE 3-10 Install O2 Cell

A. Fixing seat
B. Connecting cord of O2 sensor
C. O2 sensor connector
D. O2 sensor cover
E. O2 sensor
Installation steps:

1. Rotate the O2 sensor clockwise to fix it in the fixing seat.


2. Push the O2 sensor and its fixing seat into the ventilator.
3. Insert the O2 sensor connecting cord.
4. Close the O2 sensor door.

3.11 Install Auxiliary Pressure Monitoring


Accessories
Refer to (page 9-2) 9.2 “Auxiliary Pressure”.

3.12 Install O2 Therapy Accessories


Refer to (page 6-13) 6.5.10 “O2 Therapy”.

3.13 Install CO2 Monitoring Accessories


Refer to (page 7-3) 7.2 “Prepare for Measurement”.

3.14 Install SpO2 Monitoring Accessories


Refer to (page 8-3) 8.3 “Monitoring Steps”.

Operator’s Manual of Ventilator 3 - 13


Install SpO2 Monitoring Accessories Installations

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3 - 14 Operator’s Manual of Ventilator


4.0 Interface

Display Control...........................................................................................................................................................................................4-2
Waveforms ....................................................................................................................................................................................................4-3
Measured Values .......................................................................................................................................................................................4-4
Big Numeric..................................................................................................................................................................................................4-5
History..............................................................................................................................................................................................................4-5
Freeze...............................................................................................................................................................................................................4-9
Screenshot ....................................................................................................................................................................................................4-9
Lock Screen ..................................................................................................................................................................................................4-9

Operator’s Manual of Ventilator 4-1


Display Control Interface

4.1 Display Control


2

6 3

5 4

FIGURE 4-3 Display Control

The control unit is composed of a small number of operating components. Main operating
components are listed below.

1. Display (touch screen)


The display shows the software interface of the ventilator system. You can touch the screen to
select and change settings.
2. Alarm indicator
The alarm indicator indicates different levels of alarms with different colors and flashing
frequencies when alarms are triggered.
3. Master control knob
Press the control knob to select menu items or confirm settings. Rotate the knob clockwise or
counterclockwise to scroll through menu items or change settings.
4. Battery indicator
• Lit: when the ventilator is powered by an external power supply and the batteries are being
charged or are already fully charged.
• Flashing: when the ventilator is being powered by the batteries.
• Not lit: when the ventilator does not have a battery installed.
5. External power indicator
• Lit: when the ventilator is connected to an external power supply.
• Not lit: when the ventilator is not connected to an external power supply.
6. Power switch (with indicator)
Press the key to power on/off the system. The indicator is on when the ventilator is powered on
and off when the ventilator is powered off.

4-2 Operator’s Manual of Ventilator


Interface Waveforms

4.2 Waveforms
1 2 3 4 5 6 7 8 9 10 11 12 13

16 15 14

FIGURE 4-3 Waveforms

NO. WAVEFORMS DESCRIPTION


1 Ventilation mode field Shows the current ventilation mode.
2 Ventilation type field • Displays the icon when the oro-nasal mask or
other mask is used.
• Displays the icon when the ET/Trach tube is
used.
3 Patient type/inspiratory Select the patient type icon and set related
trigger icon field information in the interface that appears. The
icon is shown when the inspiration is triggered.
4 Prompt message field Displays current prompt messages.
5 Alarm message field Displays current alarm messages. When there are
multiple alarm messages, the system displays the
number of alarms. In this case, you can click on the
alarm message field and view current alarm
messages, alarm occurrence time and alarm level, as
well as suggested measures after the occurrence of
an alarm or alarm help information in the interface
that appears.
TABLE 4-1 Waveforms

Operator’s Manual of Ventilator 4-3


Measured Values Interface

NO. WAVEFORMS DESCRIPTION


6 Inactivated alarm When the icon is displayed, it indicates that
message field there is a recent alarm but the alarm conditions have
disappeared. You can click this icon and view recent
alarms in the interface that appears. You can also
clear recent alarms by pressing the [Reset] button.
7 Audio Pause prompt field When the 120s alarm sound pause countdown icon
is displayed, it indicates that an alarm is
triggered and the alarm sound has been paused.
8 Gas supply icon field You can select the icon and set O2 supply, check
the blower status and blower running hours in the
interface that appears.
9 USB icon field This icon is highlighted when the system is
connected to a recognizable USB device. You can
select this icon to capture the screen and export the
screenshot, export the data, transfer settings, and
perform other actions in the interface that appears.
10 Network icon field • Displays the icon when the [Network Type] is
set to [WLAN] or [BED_HOT].
• Displays the icon when the [Network Type] is
set to [LAN].
Refer to (page 5-7) 5.4.10.1 “Network Type Setup”.
11 System time field Displays the current system time. By selecting this
field, you can set the time and date of the ventilator
in the interface that appears.
12 Power status icon field Displays the current power supply status of the
system.
13 Soft key field Displays Audio Pause, Alarms, O2 ↑ Flush, Ramp,
Paux, Lock, Menu, and Standby soft keys.
14 Waveforms/Parameters/ Displays waveforms, monitoring parameters, and
Trends field trends.
15 Ventilation mode setup Displays ventilation setup keys.
field
16 Parameter setup shortcut Displays the ventilation setting parameters
key field corresponding to the ventilation modes.
TABLE 4-1 Waveforms

4.3 Measured Values


Select the [Values] key to open the interface as shown below.

4-4 Operator’s Manual of Ventilator


Interface Big Numeric

FIGURE 4-3 Measured Values

4.4 Big Numeric


Select the [Big Numeric] key to open the interface as shown below. You can view the patient leak and
trends in the interface.

FIGURE 4-4 Big Numeric

4.5 History
Select the icon to open the interface as shown in FIGURE 4-5. You can view tabular trend, graphic
trend, setting trends and event logbook in the interface.

Operator’s Manual of Ventilator 4-5


History Interface

4.5.1 Graphic Trend


Graphic trends record the trend of parameter values at specified time points and describe the
changes in the measured results of parameters using a curve. Each dot on the curve stands for the
physiological parameter value at the specific time point. Graphic trends can also record parameter
alarm events.

Current cursor. The


corresponding time is
displayed on top of the
cursor. If an alarm is
triggered at this time,
the corresponding alarm
information will also be
displayed on top of the
cursor.

The parameter data for


the time point
indicated by the cursor.

Event marker. A colored dotted line indicates that some parameter alarm event
happens at the time point. A parameter alarm event is marked with a dotted line in
the color matching the alarm level. If multiple events happen, the line is in the color
matching the highest alarm level.

FIGURE 4-5 Graphic Trend

4.5.1.1 About Graphic Trend


• Graphic Trend displays the time and date on the horizontal axis.
• Graphic Trend displays the parameter data on the vertical axis.
• Graphic Trend displays the most recent trend data on the rightmost side.
• The system does not save the graphic trend data for the Standby mode.
• The system can record the trend data for 120 consecutive hours.
• If an alarm was triggered for a parameter during the trend recording period and the parameter
record for the alarm can be located, the graphic trend will mark the parameter data in the color
matching the alarm level.
• Select [Previous Event] to move the cursor to the previous event from its current position.
• Select [Next Event] to move the cursor to the next event from its current position.

4.5.1.2 Zoom
In the Graphic Trend interface, you can set [Zoom] to [5 min], [10 min], [15 min], [30 min], [1 Hour], or
[2 Hour].

4.5.1.3 Display GroupOthersOthers


In the Graphic Trend interface, you can set [Display Group] to [Volume], [Pressure], [Time], [Gas],
[SpO2], [Paux], [Others], or [All].

4-6 Operator’s Manual of Ventilator


Interface History

4.5.1.4 Group Setup


In the Graphic Trend interface, you can choose [Group Setup] to customize the display group in the
interface that appears. You can also choose [Save as] to change the name of group. [Group Setup] in
this interface will affect the display group of the Graphic Trend interface.

4.5.2 Tabular Trend


In the Tabular Trend interface, you can view the monitoring parameter data and events of a patient.

Cursor

Parameter

FIGURE 4-6 Tabular Trend

4.5.2.1 About Tabular Trend


• Tabular Trend displays the time and date on the horizontal axis.
• Tabular Trend displays the parameter data on the vertical axis.
• Tabular Trend displays the most recent trend data on the rightmost side.
• The system does not save the graphic trend data for the Standby mode.
• The system can display the trend data for 120 consecutive hours.
• If an alarm was triggered for a parameter during the trend recording period and the parameter
record for the alarm can be located, the tabular trend will mark the parameter in the color
matching the alarm level.
• Select [Previous Event] to move the cursor to the previous event from its current position.
• Select [Next Event] to move the cursor to the next event from its current position.

4.5.2.2 Interval
In the Tabular Trend interface, you can set [Interval] to [1 min], [5 min], [10 min], [15 min], [30 min], [1
Hour], or [2 Hour].

4.5.2.3 Display Group


In the Tabular Trend interface, you can set [Display Group] to [Volume], [Pressure], [Time], [Gas],
[SpO2], [Paux], [Others], or [All].

Operator’s Manual of Ventilator 4-7


History Interface

4.5.3 Setting Trends


Setting Trends is used to record the ventilation mode settings and parameter settings.

Ventilation
mode and Cursor
settings
parameters

FIGURE 4-7 Setting Trends

4.5.3.1 About Setting Trends


• Settings Trends displays the time and date on the horizontal axis.
• Settings Trends displays the parameter data on the vertical axis.
• Settings Trends displays the most recent trend data on the rightmost side.
• The system can store up to 5000 events.

4.5.4 Event Logbook


Event Logbook records such events as power on/off, ventilation mode setup, ventilation parameter
setup, technical alarm, physiological alarm, standby status, starting ventilation, special function,
default settings management, calibration, audio paused and O2 therapy events.

Event Logbook
details

FIGURE 4-8 Event Logbook

4-8 Operator’s Manual of Ventilator


Interface Freeze

4.5.4.1 About Event Logbook


• Event Logbook displays the most recent trend data at the top.
• The system can store up to 10,000 events.

NOTE: The system can store up to 10,000 events. After the number of
events exceeds 10,000, the earliest event will be overwritten by
the latest event.

4.5.4.2 Filter
In the Event Logbook interface, you can filter [High Alarms], [Med Alarms], [Low Alarms], [Operation
Information], [All Events] and [All Alarms].

4.6 Freeze
The freeze function pauses real-time refreshes of waveforms on the screen to facilitate a brief review
of the patient's data for more in-detail examination of the patient's conditions within the period of
time. The data for review is the waveform for the 60 seconds prior to the freeze action.

4.6.1 Enter Freeze Status


Tap the key when the system is in a non-Standby and non-freeze status. The screen prompts
[Freeze Active. Press the Freeze Key to Unfreeze] and the system enters the freeze status, with a freeze
cursor shown on the screen near the waveforms. You can select the cursor and rotate the master
control knob clockwise or counterclockwise to move the cursor to review the waveforms. The
waveforms cannot be refreshed in the freeze status while the data in the parameter field can be
refreshed normally.

4.6.2 Exit Freeze Status


In freeze status, press the key again to exit freeze status. In freeze status, if no operation is
performed on the ventilator for more than three minutes, the system exits freeze status automatically.

4.7 Screenshot
Tap the key in the interface and the system automatically takes a screenshot of the current
interface and saves the screenshot as an image. The system can store up to 50 screenshots.

4.8 Lock Screen


After you tap the [Lock] key in the interface, the ventilator enters the locked status. Only the [Audio
Pause] key, the [O2 ↑ Flush] key, and the [Lock] key work when the ventilator is in the locked status.
You can tap the key again to unlock the screen.

Operator’s Manual of Ventilator 4-9


Lock Screen Interface

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4 - 10 Operator’s Manual of Ventilator


5.0 System Setup

Export via USB.............................................................................................................................................................................................5-2


Basic Settings...............................................................................................................................................................................................5-3
Interface Settings ......................................................................................................................................................................................5-4
System Setup...............................................................................................................................................................................................5-5
Manufacturer Service Setup...............................................................................................................................................................5-9

Operator’s Manual of Ventilator 5-1


Export via USB System Setup

5.1 Export via USB


The export function refers to exporting some data or settings of the ventilator to a USB flash drive.

NOTE: To enable the export function, you need to be granted the required
permissions, or you can contact the Customer Service Department for
help.

5.1.1 Export Screenshot


The Export Screenshot function refers to exporting saved screenshots of the ventilator. The exported
screenshot is in the jpg format. This ventilator can store up to 50 screenshots.

To export screenshots, follow the steps below.

1. Insert a USB flash drive into the USB port of the ventilator. The icon in the interface is
highlighted.
2. Choose the icon to open the [Data Transfer] interface.
3. Choose the [Export Screenshot] tab in the interface that appears and then select the [Export
Screenshot] key. The system will check the USB flash drive space to ensure it is enough. If there is
sufficient space, the system will start to export the screenshots.
4. After the export process is completed, select [Remove USB Device] to remove the USB flash
drive.

5.1.2 Export Data


The Export Data function refers to exporting data, such as the patient information, the current
settings and parameters, the current alarm limits, and trends of the ventilator.

To export data, follow the steps below.

1. Insert a USB flash drive into the USB port of the ventilator. The icon in the interface is
highlighted.
2. Choose the icon to open the [Data Transfer] interface.
3. Choose the [Export Data] tab in the interface that appears and then select the [User Export] key.
The system will check the USB flash drive space to ensure it is enough. If there is sufficient space,
the system will start to export the data such as the patient's ventilation information, the current
settings and parameters, the current alarm limits, and historical data. The exported data is in the
html format.
4. If you need to export other data such as the calibration data, the event logbook, and the system
selftest logbook, select the [Factory Export] tab and then enter the system password, and the
system will check the USB flash drive space to ensure it is enough. If there is sufficient space, the
system will start to export data. The exported data is encrypted in the format of “blg”.
5. After the export process is completed, select [Remove USB Device] to remove the USB flash
drive.

NOTE: To view the content of a blg file, please contact the Customer Service
Department for help.

5.1.3 Transfer Settings


You can export or import settings during the use of the ventilator.

To export settings:

1. Ensure that the ventilator is in the Standby mode.

5-2 Operator’s Manual of Ventilator


System Setup Basic Settings

2. Insert a USB flash drive into the USB port of the ventilator. The icon in the interface is
highlighted.
3. Choose the icon to open the [Data Transfer] interface.
4. Choose the [Transfer Settings] tab in the interface that appears, enter the system password and
select the [Export Settings] key. The system will check the USB flash drive space to ensure it is
enough. If there is sufficient space, the system will save the current settings and machine
defaults to the USB device.
5. After the export process is completed, select [Remove USB Device] to remove the USB flash
drive.
To import settings:

1. Ensure that the ventilator is in the Standby mode.


2. Insert a USB flash drive into the USB port of the ventilator. The icon in the interface is
highlighted.
3. Choose the icon to open the [Data Transfer] interface.
4. Choose the [Transfer Settings] tab in the interface that appears, enter the system password, and
then select the [Import Settings] key. The system will upload the settings in the USB flash drive
to the ventilator.
5. After the export process is completed, select [Remove USB Device] to remove the USB flash
drive.

5.2 Basic Settings


5.2.1 Set IBW/Height
1. Choose [Menu] → [Setup] → [Ventilation].
2. Set [IBW/Height]: Select [Patient Settings] to set it to [IBW] or [Height]. For details about [Patient
Settings], refer to (page 6-2) 6.2.1 “Set Patient Information on the Ventilator”.

5.2.2 Set Increase O2% During O2 ↑


1. Choose [Menu] → [Setup] → [Ventilation].
2. Set [Increase O2% during O2 ↑ ]: Set the patient's O2 increase amplitude. When O2 ↑ is
started, the system compares the “current oxygen concentration plus oxygen increase
amplitude” with “100 vol.%” and ventilates with the smaller value.

5.2.3 Set O2 Sensor Monitoring


1. Choose [Menu] → [Setup] → [O2 Sensor].
2. Set [Monitoring]: (ON) or (OFF). When the switch is ON, the oxygen concentration of
the patient's inhaled gas can be monitored. The switch can be turned off if the oxygen
concentration monitoring function provided by the ventilator is not required. In this case, the
prompt message [O2 Monitoring Off] is displayed on the screen. When the oxygen sensor
monitoring is off, the ventilator will disable relevant alarm messages and prompt messages.

CAUTION: It is allowed to switch off oxygen concentration monitoring. However, it


is not suggested to do so continuously to prevent potential patient
injury.

NOTE: The system total response time for oxygen concentration monitoring is
23 seconds.

Operator’s Manual of Ventilator 5-3


Interface Settings System Setup

NOTE: It takes around three minutes from your powering on the ventilator to
the ventilator's reaching the O2% monitoring performance specified in
(page B-7) B.7 “Ventilator Accuracy” of this manual.

5.2.4 Set O2 Supply Type


Choose the icon and set [O2 Supply Type] to [HPO] or [LPO] in the interface that appears.

5.3 Interface Settings


5.3.1 Screen Brightness Adjustment
1. Choose [Menu] → [Screen] → [Brightness/
Volume].
2. Select or to adjust to the corresponding default brightness.
3. If the above screen brightness is not satisfactory, you can set the screen brightness directly.
indicates a lower brightness, and indicates a higher brightness. When the ventilator is
battery-powered, you can set the brightness to a lower level to save power usage.

5.3.2 Key Volume Adjustment


1. Choose [Menu] → [Screen] → [Brightness/
Volume].
2. Select or to adjust to the corresponding default key volume.
3. If the above key volume is not satisfactory, you can set the key volume directly. indicates a
lower volume level, indicates a higher volume level, and indicates that the volume is
turned off.

5.3.3 Screen Setup


1. Choose [Menu] → [Screen] → [Screen Setup].
2. Select the corresponding icons to set the displayed waveform count and the waveform type.
3. If you need to adjust the specific waveform and measured values at a position, please set
[Layout Setup Switch] to (ON). Then select the waveform or measured value in the interface
and set the required waveform or measured value name in the interface that appears. If you
need to disable this function, please set [Layout Setup Switch] to (OFF).
4. Select [Defaults] as necessary to restore the default settings.

5.3.4 Color Setup


1. Choose [Menu] → [Screen] → [Color].
2. Set the parameter display colors. The colors of waveforms, parameters, and parameter alarm
limits are linked. If you set a waveform or parameter color, the color of their relevant parameter
or waveform also changes. The color of their related parameter alarm limit will be a darker shade
of the set color. The following table lists the parameters, waveforms, and related alarm limits.

COLOR WAVEF
SETUP ORM PARAMETER ALARM LIMIT
Pressure Paw Ppeak, PEEP, PEEPi, PEEPi+PEEP Paw
Flow Flow TVe, MVe, ftotal, PEF, Pt.leak, Tot.leak, Pt.Trig, Ti/Ttot, TVe, MVe, ftotal
TVe/IBW
Volume Volume / /
TABLE 5-1 Color Setup

5-4 Operator’s Manual of Ventilator


System Setup System Setup

O2 / FiO2 FiO2
CO2 CO2 EtCO2 EtCO2
SpO2 Pleth SpO2, PR, PI SpO2, PR
Paux Pes, Ptp PesE, PesI, ΔPes, ΔPtp, PtpI, PtpE, PTPes, PTPes/min /
TABLE 5-1 Color Setup

5.4 System Setup


5.4.1 Time and Date Setup
1. Choose [Menu] → [System] → enter the system password → [Setup] → [Date & Time Setup].
2. Set [Date], [Time], [Time Zone], and [DayLight Savings].
3. Set [Date Format]: [YYYY-MM-DD], [MM-DD-YYYY] or [DD-MM-YYYY].
4. Set [24 h]: (ON) or (OFF).

5.4.2 Language Setup


1. Choose [Menu] → [System] → enter the system password → [Setup] → [Language/Unit].
2. Set [Language]: Select the desired language as needed.
3. Restart the ventilator to activate the selected language.

5.4.3 Unit Setup


5.4.3.1 Pressure Unit Setup
1. Choose [Menu] → [System] → enter the system password → [Setup] → [Language/Unit].
2. Set [Pressure Unit]: [cmH2O], [hPa], or [mbar].

5.4.3.2 CO2 Unit Setup


1. Choose [Menu] → [System] → enter the system password → [Setup] → [Language/Unit].
2. Set [CO2 Unit]: [mmHg], [kPa], or [vol.%].

5.4.3.3 Height Unit Setup


1. Choose [Menu] → [System] → enter the system password → [Setup] → [Language/Unit].
2. Set [Height Unit]: [cm] or [inch].

5.4.3.4 Weight Unit Setup


1. Choose [Menu] → [System] → enter the system password → [Setup] → [Language/Unit].
2. Set [Weight Unit]: [Kg] or [lb].

5.4.3.5 Gas Supply Pressure Unit Setup


1. Choose [Menu] → [System] → enter the system password → [Setup] → [Language/Unit].
2. Set [Gas Supply Pressure]: [kPa], [psi], or [bar].

5.4.4 Minimum Alarm Volume Setup


1. Choose [Menu] → [System] → enter the system password → [Setup] → [Language/Unit].

Operator’s Manual of Ventilator 5-5


System Setup System Setup

2. Set [Minimum Alarm Volume] to a desired level. indicates a lower volume level, and
indicates a higher volume level.

5.4.5 Change Password


1. Choose [Menu] → [System] → enter the system password → [Setup] → [Change Password].
2. Input the current password.
3. Input the new password.
4. Input the new password again to confirm the password.

5.4.6 Set Ventilator Location


1. Choose [Menu] → [System], enter the system password, and choose [Ventilator Location]. You
can view the device ID in the interface that appears.
2. Set [Ventilator Name], [Facility] or [Department].
3. Set [Room No] or [Bed No].
• Select [Fixed]. The [Room No] and [Bed No] will be locked and cannot be changed in the
[Patient Settings] menu. For details about [Patient Settings], refer to (page 6-2) 6.2.1 “Set
Patient Information on the Ventilator”.
• Select [Unfixed]. The [Room No] and [Bed No] will be unlocked and can be changed in the
[Patient Settings] menu. For details about [Patient Settings], refer to (page 6-2) 6.2.1 “Set
Patient Information on the Ventilator”.

5.4.7 Patient Management


1. Choose [Menu] → [System], enter the system password, and choose [Patient Management].
2. Select [Field]. In the interface that appears, select the fields to be set in the [Patient Settings]
menu. For details about [Patient Settings], refer to (page 6-2) 6.2.1 “Set Patient Information on
the Ventilator”.
3. Select [ADT Query].
• Set [Find Patient] to [All Patients] or [Current Department Patients].
• In the interface that appears, select the fields to be set in the [Find Patient] menu. For details
about [Find Patient], refer to (page 6-2) 6.2.2 “Get Patient Information from ADT Server”.
4. Select [Discharge Patient]. Set [Clear the Room and the Bed number when discharge]: (ON)
or (OFF). With the switch on and [Room No] and [Bed No] being [Unfixed], the ventilator
will clear the room number and the bed number when discharging a patient. With the switch
off, the ventilator will keep the room number and the bed number when discharging a patient.

5.4.8 Default Value Management


The ventilator provides the following types of settings.

5-6 Operator’s Manual of Ventilator


System Setup System Setup

• Factory defaults, that is, the preset values by the factory.


• User defaults. You can adjust the ventilator's settings as needed and save the settings as user
defaults.
• Recent settings. In actual application, operators may change some settings. The ventilator
stores these settings in real time. The stored settings are recent settings. The ventilator
automatically loads the latest settings after being powered on.
• Current settings, that is, current settings of the ventilator.

5.4.8.1 Use Current Settings


You can adjust the ventilator's settings as needed and save the settings as user defaults.

1. Choose [Menu] → [System], enter the system password, and choose [Defaults].
2. Select [Use Current Settings] to save the current settings as user defaults.

5.4.8.2 Restore Factory Defaults


You can manually restore factory defaults as needed during the use of the ventilator.

1. Choose [Menu] → [System], enter the system password, and choose [Defaults].
2. Select [Restore Factory Defaults] to restore user defaults to factory defaults.

5.4.8.3 Default Settings Application


When the ventilator is used on a new patient, the system loads default settings automatically. When
the ventilator is used on the same patient, the system loads recent settings automatically.

5.4.8.4 Restore Recent Settings Automatically


When the ventilator is used on the same patient after being powered on, the system adopts recent
settings automatically.

NOTE: The system supports automatic saving of monitoring trends, event


logbooks (including alarm logbooks), setting trends, patient settings,
and device settings (including alarm settings). When there are changes
to the above data, the system will automatically store the changed data
to the flash memory chips of the main board. When the ventilator
restarts, the data are restored automatically.

5.4.9 Nurse Call Setup


See (page 10-10) 10.12 “Nurse Call”.

5.4.10 Network Setup


5.4.10.1 Network Type Setup
1. Choose [Menu] → [System], enter the system password, and choose [Interface].
2. Set [Network Type]: [LAN], [WLAN], or [BED_HOT].

5.4.10.2 LAN/WLAN Setup


1. Choose [Menu] → [System], enter the system password, and choose [Interface].
2. Select [LAN Setup] or [WLAN Setup] to set related items in the interface that appears.

5.4.10.3 Central Station Setup


The ventilator can be connected to the central monitoring system for data transmission. The
ventilator sends the parameters, waveforms, and alarms of the ventilator to the central monitoring
system (CMS). You can view the patient's ventilation data and alarms on the CMS.

Operator’s Manual of Ventilator 5-7


System Setup System Setup

1. Choose [Menu] → [System], enter the system password, and choose [Interface].
2. Select [Central Station Setup] to set related items in the interface that appears.
• Set [Network disconnection alarm]: (ON) or (OFF). When this function is enabled,
the ventilator will give an alarm when the ventilator is disconnected from the CMS, e-
Gateway or the monitor.
• Set [Select CMS]: (ON) or (OFF). When this function is enabled, the central
monitoring system can be selected for the ventilator.
• Select [Add Central Station] to set the relevant items of the central station to be added in the
interface that appears.

5.4.10.4 Device Discover


Set the multicast parameters so that the ventilator and monitor, and the ventilator and central
monitoring system can discover each other. Only the internal devices in the same multicast group
can discover each other.

1. Choose [Menu] → [System], enter the system password, and choose [Interface].
2. Select [Device Discover] to set related items and check the network connection status in the
interface that appears.

5.4.10.5 Information Security Setup


1. Choose [Menu] → [System], enter the system password, and choose [Interface].
2. Select [Information Security] to set [Encryption Connection Type] in the interface that appears.
• [Only Private Encryption]: Mindray private encryption is used to encrypt the transmission data.
Devices connected to the SSL (Secure Socket Layer) encryption are not supported.
• [SSL Encryption Priority]: Devices that support SSL encryption are preferentially connected in
SSL encryption mode, and devices that do not support SSL encryption are connected in private
encryption mode.

5.4.10.6 ADT Setup


The ADT application gateway is usually deployed in the eGateway. You can receive patient
information from the ADT server of the hospital through the ADT application gateway.

1. Choose [Menu] → [System], enter the system password, and choose [Interface].
2. Select [ADT] to set related items in the interface that appears.

5.4.10.7 SNTP Setup


SNTP is used to synchronize the time of ventilator with the server.

1. Choose [Menu] → [System], enter the system password, and choose [Interface].
2. Select [SNTP] to set related items in the interface that appears. After the settings are done, you
can select [Test] to test the connection status.

5.4.10.8 HL7 Setup


You can transmit the real-time data, waveforms, and alarms of the ventilator to the hospital server
through the HL7 protocol.

1. Choose [Menu] → [System], enter the system password, and choose [Interface].
2. Select [HL7] to set related items in the interface that appears. After the settings are done, you
can select [Test] to test the connection status.

5.4.10.9 Serial Setup


You can connect an external monitor through the serial port.

5-8 Operator’s Manual of Ventilator


System Setup Manufacturer Service Setup

1. Choose [Menu] → [System], enter the system password, and choose [Interface].
2. Select [Serial] to set [Protocol] and other items in the interface that appears.

5.4.11 View System Information


Choose [Menu] → [System], enter the system password, and then choose [System Info.] to check the
software version and maintenance information of the system.

5.4.12 View Open Source information


Choose [Menu] → [Screen] → [More] to check the open source license and open source information.

5.5 Manufacturer Service Setup


Only authorized service personnel by the manufacturer have access to the [Service] tab. For further
assistance, please contact the Customer Service Department.

Operator’s Manual of Ventilator 5-9


Manufacturer Service Setup System Setup

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5 - 10 Operator’s Manual of Ventilator


6.0 Start Ventilation

Start System..................................................................................................................................................................................................6-2
Patient Management .............................................................................................................................................................................6-2
Select Mask/ET............................................................................................................................................................................................6-3
Whether to Connect Exhalation Port ...........................................................................................................................................6-3
Ventilation Mode ......................................................................................................................................................................................6-3
Alarm Limit Setup.................................................................................................................................................................................. 6-19
Start Ventilation ...................................................................................................................................................................................... 6-19
Ventilation Parameters ....................................................................................................................................................................... 6-20
Enter Standby Mode............................................................................................................................................................................ 6-21
Power off System ................................................................................................................................................................................... 6-22

Operator’s Manual of Ventilator 6-1


Start System Start Ventilation

6.1 Start System


1. Insert the power cord into the power socket. Ensure that the external power indicator is on.
2. Press the hard key.
3. The alarm indicator flashes yellow and red once in turn, and the system's speaker and buzzer
sound the system check tone once respectively.
4. The screen displays the start-up screen and the progress bar of the power-on self-test, and then
enters the system check interface.

NOTE: The system checks whether alarm tones and alarm lamps function
properly during the start-up of the ventilator. If they function properly,
the alarm indicator flashes yellow and red once in turn, and the speaker
and buzzer sound the system check tone respectively. Otherwise, do
not use the equipment and contact the Customer Service Department
immediately.

6.2 Patient Management


6.2.1 Set Patient Information on the Ventilator
When the ventilator is in the Standby mode, select the icon to open the [Patient Settings] menu:

• If you select [Last Patient], you can set [Gender], [Height] or [IBW] in this menu. Additionally,
the ventilation duration can be viewed in this menu. [Height] or [IBW] is influenced by (page
5-3) 5.2.1 “Set IBW/Height”.
• If you select [New Patient], you can set [Gender], [Height] or [IBW] in this menu. [Height] or
[IBW] is influenced by (page 5-3) 5.2.1 “Set IBW/Height”.
• Select [More] to set Room No., Bed No., Patient ID, Visit Number, Last Name, Mid Name, First
Name, Race, Weight, DOB, Age, or Paced in the menu that appears. You can also input
custom information. The setting items are influenced by (page 5-6) 5.4.7 “Patient
Management”.

6.2.2 Get Patient Information from ADT Server


The ventilator can be connected to the ADT server and obtain patient information from the ADT
server.

The procedure is as follows.

1. Connect the network cable.


2. Set the network and ensure tthe network connection is normal.
3. Select [ADT] to set server address and IP address in the interface that appears. Generally, the port
setting is not required, but you can change it as needed.
4. Select the icon to open the [Patient Settings] menu.
5. Select the [Find Patient] button to input [Facility], [Department], [Room No], [Bed No], [Patient
ID], [Visit Number] or [Patient Name] in the interface that appears. The setting items are
influenced by (page 5-6) 5.4.7 “Patient Management”.
6. Select the [Query] key and a list of conforming patient information will be displayed on the
screen.
7. Select the desired patient information from the list, and then select the [Import] button.

6-2 Operator’s Manual of Ventilator


Start Ventilation Select Mask/ET

NOTE: The IP addresses of ADT and LAN must be on the same subnet.

6.3 Select Mask/ET


This product supports invasive and non-invasive ventilation. Please select the ventilation type before
use. Select the or icon, and set mask/ET selection: [Oro-nasal mask(Vented)], [Oro-nasal
mask(Non-vented)], [Other(Total face, nasal mask etc.)] or [ET/Trach tube] in the interface that
appears.

WARNING: Check the alarm limit settings after you switch from mask ventilation to
ET/Trach tube ventilation.

NOTE: The oro-nasal mask (non-vented) or ET/Trach tube needs to be used


together with the exhalation port.

6.4 Whether to Connect Exhalation Port


Select the or icon and set [Whether exhalation port is connected] in the interface that
appears. If you need to connect the exhalation port, follow the prompts to connect the patient
tubing and exhalation port, block the tubing outlet, and calibrate the exhalation port.

NOTE: If exhalation port calibration fails, check the patient tubing for leaks. If
the failure persists, the ventilator will not be able to monitor the
patient for leaks.

6.5 Ventilation Mode


WARNING: Please properly set the expiratory pressure and inspiratory time (the
expiratory time should not be too short) during ventilation to ensure
that the exhaled gas can be sufficiently exhausted through the
expiratory port to prevent repeated carbon dioxide inhalation.

WARNING: Do not occlude the expiratory port; otherwise, apnea and repeated
carbon dioxide inhalation may occur.

WARNING: Remove the breathing mask from the patient without ventilation, as
this may result in repeated carbon dioxide inhalation.

NOTE: In the expiratory phase, the ventilator will not automatically generate
negative pressure, but may cause negative pressure because of the
patient's spontaneous inhalation.

NOTE: In the inspiratory phase, set the higher pressure alarm limit. The high
alarm of [Paw Too High] will be triggered when the pressure reaches
the higher pressure alarm limit, and the ventilator will switch to the
expiratory phase until the airway pressure reaches the preset PEEP
value. Set the higher pressure alarm limit properly to ensure patient
safety.

NOTE: During ventilation, if the waveforms in the inspiratory phase turn into
red, it indicates that the patient has spontaneous breathing or
triggered the pressure support ventilation.

Operator’s Manual of Ventilator 6-3


Ventilation Mode Start Ventilation

6.5.1 Ventilation Mode and Parameter Setup

3 4

1 2

FIGURE 6-1 Ventilation Mode

1. Ventilation mode field


Displays ventilation setup keys.
2. Parameter setup shortcut key field
Displays the ventilation setting parameters corresponding to the ventilation modes.
3. Ventilation mode custom key
Select ventilation mode custom key to open the ventilation mode setting menu. In the
menu, set the ventilation modes to be displayed in Area 1. The system will add the ventilation
modes one at a time in the order of selection.
4. O2 therapy mode field (optional)
Select ventilation mode custom key to open the ventilation mode setting menu. In the
menu, set [O2 Therapy] to (ON), and then the O2 therapy mode will be shown in Area 4.
Set [O2 Therapy] to (OFF), and then the O2 therapy mode will not be shown in Area 4.
A setting method of ventilation mode is as follows:

1. In the ventilation mode field, select the desired ventilation mode key and the available
ventilation parameters for the mode will be displayed in the interface that appears.
2. Select the keys of the desired ventilation parameters.
3. Rotate the master control knob to set the parameters to an appropriate value.
4. Press the master control knob to confirm the settings.
5. Follow the same approach to set other parameters as needed.
6. Select the [Ok] key after parameter settings are done.
A quick setting method of ventilation parameters is as follows.

1. In the parameter setup shortcut field, select the desired ventilation parameter.
2. Rotate the master control knob to set the parameters to an appropriate value.
3. Press the master control knob to confirm the settings.
4. Follow the same approach to set other parameters as needed.

6.5.2 Continuous Positive Airway Pressure (CPAP) Ventilation Mode


CPAP is continuous positive airway pressure ventilation mode. The airway pressure is held at the user-
set positive pressure level throughout the ventilation cycle. The patient breathes spontaneously and
determines his/her own breathing frequency, breath time, and tidal volume. When the system finds
that the duration that the patient does not breath spontaneously exceeds the preset apnea time, the
system will start the backup ventilation.

6-4 Operator’s Manual of Ventilator


Start Ventilation Ventilation Mode

A typical waveform of the CPAP mode is shown below.

Pressure

Spontaneous Backup
breathing Ventilation

Pbackup
CPAP

Tslope Time
Flow

Time

Apnea time

Tinsp

60/fbackup

FIGURE 6-2 CPAP Waveform

In CPAP mode, set the following ventilation parameters:

1. [O2%]: Oxygen concentration


2. [CPAP]: Continuous positive airway pressure
3. [P-Flex]: Pressure relief level
4. [Pbackup]: Inspiratory pressure of backup ventilation
5. [fbackup]: Breathing frequency of backup ventilation
6. [Tinsp]: Inspiration time of backup ventilation

6.5.3 Spontaneous/Timed (S/T) Ventilation Mode


S/T is spontaneous/timed ventilation mode, which is composed of S mode and T mode. The system
will start spontaneous ventilation upon discovery of patient's inspiration effort that reaches the
preset [Trigger]. Time of pressure rising and pressure support level are set by the user. At the
beginning of the inspiratory phase, the patient's airway pressure increases to the preset pressure level
within the preset time, and is held at this pressure level until the patient's inspiratory flow is
discovered to have reached the [E-Cycle]. When the system finds that the patient does not trigger
spontaneous respiration within the preset maximum breathing cycle (60/f ), the system will start a
timed ventilation. Timed ventilation parameters are set by users. The inspiration pressure levels of
spontaneous ventilation and timed ventilation are the same in S/T mode.

A typical waveform of the S/T mode is shown below.

Operator’s Manual of Ventilator 6-5


Ventilation Mode Start Ventilation

Pressure

Spontaneous Timed Spontaneous


ventilation ventilation ventilation

Trigger IPAP EPAP Trigger

Flow Tslope Time

E-Cycle
Trigger

Time
Tinsp

60/f < 60/f

FIGURE 6-3 S/T Waveform

In S/T mode, set the following ventilation parameters:

1. [O2%]: Oxygen concentration


2. [IPAP]: Inspiratory pressure
3. [f]: Breathing frequency
4. [Tinsp]: Inspiration time
5. [EPAP]: Positive end-expiratory pressure
6. [Tslope]: Time of pressure rising
7. [Trigger]: Trigger sensitivity
8. [E-Cycle]: Expiratory cycle sensitivity

6.5.4 Spontaneous (S) Ventilation Mode


S is spontaneous ventilation mode, which means that the system will start pressure support
ventilation (PSV) upon discovery of the patient's inspiration effort that reaches the preset [Trigger].
Time of pressure rising and pressure support level are set by the user. At the beginning of the
inspiratory phase, the patient's airway pressure increases to the preset pressure level within the
preset time, and is held at this pressure level until the patient's inspiratory flow is discovered to have
reached the [E-Cycle]. When the system finds that the duration that the patient does not breath
spontaneously exceeds the preset apnea time, the system will start the backup ventilation.

A typical waveform of the S mode is shown below.

6-6 Operator’s Manual of Ventilator


Start Ventilation Ventilation Mode

Pressure

Spontaneous Backup Ventilation


ventilation

Trigger Psupp EPAP Pbackup


Tslope Time
Flow

E-Cycle
Trigger

Time

Inspiration time of
backup ventilation

Apnea time 60/fbackup

FIGURE 6-4 S Waveform

In S mode, set the following ventilation parameters.

1. [O2%]: Oxygen concentration


2. [Psupp]: Spontaneous inspiratory pressure
3. [EPAP]: Positive end-expiratory pressure
4. [Tslope]: Time of pressure rising
5. [P-Flex]: Pressure relief level
6. [Pbackup]: Inspiratory pressure of backup ventilation
7. [fbackup]: Breathing frequency of backup ventilation
8. [Tinsp]: Inspiration time of backup ventilation
9. [Trigger]: Trigger sensitivity
10. [E-Cycle]: Expiratory cycle sensitivity

6.5.5 Timed (T) Ventilation Mode


T is timed ventilation mode, which means that the system will starts pressure support ventilation
(PSV) based on the user-set ventilation cycle. Time of pressure rising and pressure support level are
set by the user. At the beginning of the inspiratory phase, the patient's airway pressure increases to
the preset pressure level within the preset time, and is held at this pressure level. The time of holding
depends on the user-set inspiration time.

A typical waveform of the T mode is shown below.

Operator’s Manual of Ventilator 6-7


Ventilation Mode Start Ventilation

Pressure

Timed Timed Timed


ventilation ventilation ventilation

IPAP EPAP

Time
Flow Tslope

Time

Tinsp

60/f 60/f 60/f

FIGURE 6-5 T Waveform

In T mode, set the following ventilation parameters.

1. [O2%]: Oxygen concentration


2. [IPAP]: Inspiratory pressure
3. [f]: Breathing frequency
4. [Tinsp]: Inspiration time
5. [EPAP]: Positive end-expiratory pressure
6. [Tslope]: Time of pressure rising

6.5.6 Pressure-Assist/Control (P-A/C) Ventilation Mode


P-A/C is pressure-assist/control ventilation mode. In P-A/C, the patient's airway pressure rises to the
preset pressure level within the time of pressure rising, and is held at this level till inspiration time is
completed. Then the system switches to expiration. The change of the gas supply flow rate varies
with the resistance and compliance of the patient's lungs during the pressure holding period. During
the expiratory phase, synchronization trigger is supported. Namely, when the ventilator discovers
patient inspiratory effort, it delivers the next mechanical ventilation breath immediately.

A typical waveform of the P-A/C mode is shown below.

6-8 Operator’s Manual of Ventilator


Start Ventilation Ventilation Mode

Pressure
Tslope
IPAP

EPAP Trigger
Time
Tinsp

60/f

Flow

Trigger

Time

FIGURE 6-6 P-A/C Waveform

In P-A/C mode, set the following ventilation parameters.

1. [O2%]: Oxygen concentration


2. [IPAP]: Inspiratory pressure
3. [f]: Breathing frequency
4. [Tinsp]: Inspiration time
5. [EPAP]: Positive end-expiratory pressure
6. [Tslope]: Time of pressure rising
7. [Trigger]: Trigger sensitivity

6.5.7 Volume Assured Pressure Support (VAPS) Ventilation Mode


NOTE: Please adjust the maximum and minimum pressure range properly to
ensure that the actual inspiratory pressure meets the target tidal
volume adjustment requirements.

VAPS is volume assured pressure support ventilation mode, which means that the system will adjust
the support pressure of inspiratory phase based on the tidal volume set by the user. When the system
finds that the inspiratory effort of the patient reaches the preset [Trigger], the system starts a
spontaneous ventilation. The inspiratory pressure is adjusted according to the tidal volume set by the
user. At the beginning of the inspiratory phase, the patient's airway pressure increases to the preset
pressure level within the preset time, and is held at this pressure level until the patient's inspiratory
flow is discovered to have reached the [E-Cycle]. If the system finds that the patient's respiratory cycle
exceeds the maximum respiratory cycle set by the user, the ventilator will start a volume-guaranteed
timed ventilation. The inspiratory pressure is adjusted according to the tidal volume set by the
patient, and the inspiratory time and breathing frequency are set by the user.

A typical waveform of the VAPS mode is shown below.

Operator’s Manual of Ventilator 6-9


Ventilation Mode Start Ventilation

Pressure
Spontaneous
Timed ventilation
Pmax
ventilation
↑△ Paw ≤ 3 cmH2O

Pmin

EPAP Trigger

Flow Tslope Time

E-Cycle
Trigger
Time

Tinsp

60/f

FIGURE 6-7 VAPS Waveform

In VAPS mode, set the following ventilation parameters.

1. [O2%]: Oxygen concentration


2. [TV]: Tidal volume
3. [f]: Breathing frequency
4. [Tinsp]: Inspiration time
5. [EPAP]: Positive end-expiratory pressure
6. [Tslope]: Time of pressure rising
7. [Pmin]: Minimum inspiratory pressure
8. [Pmax]: Maximum inspiratory pressure
9. [AE]: Switch of adaptive EPAP
10. [EPAPmin]: Minimum expiratory pressure
11. [EPAPmax]: Maximum expiratory pressure
12. [Trigger]: Trigger sensitivity
13. [E-Cycle]: Expiratory cycle sensitivity

6.5.8 Proportional Pressure Ventilation (PPV) Mode


WARNING: In PPV mode, set Pmax and TVmax limits properly. Too high limits may
result in too high pressure and flow, and too low limits may result in
hypoventilation.

WARNING: Pmax and TVmax limits are not alarm limits. When using PPV mode for
ventilation, set appropriate alarm limits and pay attention to relevant
alarm information.

WARNING: PPV ventilation is applicable to patients with spontaneous breathing.


Please assess the intensity of spontaneous expiration before use. PPV
ventilation is not recommended for patients with weak spontaneous
breathing.

6 - 10 Operator’s Manual of Ventilator


Start Ventilation Ventilation Mode

NOTE: To achieve the optimal PPV use, please properly evaluate the patient's
lung compliance and airway resistance, and set the corresponding Max
E and Max R parameters. Please regularly assess the ventilation effect
according to the patient's condition.

PPV is proportional pressure ventilation mode, which means the system will provide a certain
proportion of support ventilation according to the patient's inspiratory effort. When the system finds
that the inspiratory effort of the patient reaches the preset [Trigger], the system starts a spontaneous
ventilation. The inspiratory pressure is adjusted according to the tidal volume set by the user. The
inspiratory pressure stops changing until the patient's inspiratory flow is discovered to have reached
the [E-Cycle]. If the system finds that the patient's respiratory cycle exceeds the maximum respiratory
cycle set by the user, the ventilator will start a timed ventilation.

A typical waveform of the PPV mode is shown below.

Pressure Spontaneous Spontaneous Backup Pmax


ventilation ventilation ventilation

Trigger EPAP
Added inspiration effort Tslope Time
Flow

E-Cycle

Time

Tinsp

60/f
Volu TVmax

Time

FIGURE 6-8 PPV Waveform

In PPV mode, set the following ventilation parameters.

1. [O2%]: Oxygen concentration


2. [PPV%]: Percentage of PPV assist or gain
3. [Max E]: Maximum elastance
4. [Max R]: Maximum resistance
5. [EPAP]: Positive end-expiratory pressure
6. [TVmax]: Maximum tidal volume limit
7. [Pmax]: Maximum inspiratory pressure
8. [Tslope]: Time of backup ventilation pressure rising
9. [IPAP]: Inspiratory pressure
10. [f]: Breathing frequency

Operator’s Manual of Ventilator 6 - 11


Ventilation Mode Start Ventilation

11. [Tinsp]: Inspiration time of backup ventilation


12. [Trigger]: Trigger sensitivity
13. [E-Cycle]: Expiratory cycle sensitivity

6.5.9 Spontaneous/Timed Ventilation Plus (S/T+) Ventilation Mode


S/T+ mode is spontaneous/timed ventilation plus ventilation mode. It is composed of the S mode
and T mode. It works in the same way as the S/T mode. [Psupp] for spontaneous and timed
ventilation triggered in S/T+ mode can be set separately.

A typical waveform of the S/T + mode is shown below.

Pressure Timed
ventilation
Spontaneous Spontaneous
ventilation ventilation

Trigger Psupp EPAP IPAP Trigger


Time
Tslope
Flow

E-Cycle
Trigger

Time
Tinsp

60/f < 60/f

FIGURE 6-9 S/T+ Waveform

In S/T+ mode, set the following ventilation parameters.

1. [O2%]: Oxygen concentration


2. [IPAP]: Time controlled inspiratory pressure
3. [f]: Breathing frequency
4. [Tinsp]: Inspiration time
5. [EPAP]: Positive end-expiratory pressure
6. [Tslope]: Time of pressure rising
7. [Psupp]: Spontaneous inspiratory pressure
8. [Trigger]: Trigger sensitivity
9. [E-Cycle]: Expiratory cycle sensitivity

6 - 12 Operator’s Manual of Ventilator


Start Ventilation Ventilation Mode

6.5.10 O2 Therapy
O2 therapy is a method to increase O2 concentration in the airway at normal pressure through simple
tube connections. O2 therapy is a medical measure which can increase O2 concentration in the
alveolar gas and facilitate O2 diffusion so as to increase PaO2 and SpO2 saturation and relieve or
correct hypoxia by increasing O2 concentration in the inspired gas. O2 therapy is a way for hypoxia
prevention or treatment, providing O2 concentration higher than that in the air.

WARNING: O2 therapy can only be used on patients with spontaneous breathing.

WARNING: During O2 therapy, all physiological alarms are shielded except O2%
physiological alarms.

WARNING: Some ventilation parameters related to breathing are not monitored


during O2 therapy.

WARNING: Use SpO2 monitoring for patients who are dependent only on an
increased defined O2%. Otherwise, a deterioration in the patient's
condition may not be recognized.

WARNING: Only use oxygen masks or nasal cannulas for O2 therapy. The patient
may be at risk if unsuitable masks are used.

WARNING: Insufficient source pressure may cause inaccurate control of oxygen


concentration.

WARNING: This ventilator is a high flow device. Its maximum oxygen consumption
can reach at 80 L/min during O2 therapy. Ensure the high-pressure O2
supply is sufficient so as not to affect the operation of other devices.

6.5.10.1 Preparing for O2 Therapy


WARNING: Do not use antistatic or conductive patient tubing. The use of such
materials increases the risk of an electric shock for the patient and the
risk of fire breaking out in an oxygen-enriched atmosphere.

Operator’s Manual of Ventilator 6 - 13


Ventilation Mode Start Ventilation

6.5.10.1.1 Using O2 Therapy Masks for O2 Therapy

A E

C F

FIGURE 6-10 Using O2 Therapy Masks for O2 Therapy

A. Mask
B. Patient tubing
C. Humidifier outlet
D. Watertrap
E. Bacteria filter
F. Humidifier inlet
Installation steps:

1. Install the bacteria filter onto the inspiratory port of the ventilator.
2. Connect the bacteria filter to the humidifier inlet via the tubing.
3. Connect the humidifier outlet to the watertrap via the tubing.
4. Connect the watertrap with the mask via the tubing.
5. Place the patient tubing onto the support arm hook.

6 - 14 Operator’s Manual of Ventilator


Start Ventilation Ventilation Mode

6.5.10.1.2 Using Nasal Cannula for O2 Therapy

C
E

FIGURE 6-11 Using Nasal Cannula for O2 Therapy

A. Patient tubing with heated-wire


B. Nasal cannula
C. Humidifier outlet
D. Bacteria filter
E. Humidifier inlet
Installation steps:

1. Install the bacteria filter onto the inspiratory port of the ventilator.
2. Connect the bacteria filter to the humidifier inlet via the tubing.
3. Connect the humidifier outlet to the nasal cannula via the tube with heated-wire.

6.5.10.2 Switching on O2 Therapy


WARNING: The device must be used under the supervision of qualified medical
staff, so that help is immediately available if malfunctions occur or the
patient has insufficient spontaneous breathing.

1. In the ventilation mode field, select the [O2 Therapy] key and the ventilation parameters for the
mode will be displayed in the interface that appears.
2. Set [Flow] and [O2%] to an appropriate value as needed.

Operator’s Manual of Ventilator 6 - 15


Ventilation Additives Start Ventilation

3. Select the [Ok] key after parameter settings are done.

ROX

FIGURE 6-12 O2 Therapy

6.5.10.3 ROX
The ROX index is the ratio of oxygen saturation to inspired oxygen concentration divided by the
patient's spontaneous breathing rate, calculated as (SpO2/FiO2)/fspn. When the ventilator is able to
obtain SpO2 and FiO2 monitoring, ROX monitoring is provided. When the ventilator is connected with
an external monitor, you can choose the monitoring parameter [fspn] and set [Obtain fspn from
monitor] to (ON) in the interface that appears. In this case, the ventilator can obtain the
monitored value of [fspn] from the monitor to calculate ROX.

To set an ROX threshold:

1. Select the icon and set [ROX Threshold Prompt] to (ON) in the interface that appears.
2. Select the high or low threshold setting box on the right, and rotate the master control knob to
set the parameter to an appropriate value.

6.6 Ventilation Additives


6.6.1 Backup Ventilation Mode
Backup ventilation mode is a mode started when the ventilator discovers patient apnea in CPAP and
S modes. The backup ventilation mode can be exited only when two consecutive spontaneous
breaths are discovered and the ventilation mode is switched.

The backup ventilation mode provided by this ventilator is pressure controlled ventilation (PCV)
mode. After entering backup ventilation, the ventilator performs ventilation in P-A/C mode with the
set EPAP, f, and Tinsp of the backup ventilation (other parameter settings remain the same).

6.6.2 Leakage Compensation

6 - 16 Operator’s Manual of Ventilator


Start Ventilation Ventilation Additives

The leakage from the patient tubing and mask may cause that the gas volume delivered to the
patient's lung is lower than the setting value. The leakage also may cause the false inspiratory trigger
or difficult switching between inspiratory and expiratory.

The ventilator provides leakage compensation and the amount of leakage can be used for the
calculation of real-time leakage flow in next breathing cycle. The real-time leakage flow rate is
proportionally related to airway pressure. The higher the airway pressure, the higher the leakage flow
rate.

In the expiration stage, the ventilator automatically increases the gas supply flow rate to compensate
for the leakage in order to prevent the expiratory pressure drop caused by leakage. In order to
prevent the false inspiratory trigger, the flow trigger working mechanism is based on the
compensated flow.

The ventilator primarily maintains the preset pressure and increases the delivered flow to
compensate for leakage until the ventilator's maximum delivery capacity is reached.

The waveform of flow and volume, and the monitoring parameter of TV and MV displayed on the
ventilator are all values compensated by leakage.

6.6.3 Adaptive EPAP


When the Adaptive EPAP function is enabled, the ventilator detects for any apnea events. When such
an event is discovered, the ventilator increases the expiratory pressure according to the preset range
set by the user. When no such events are discovered for a period of time, the ventilator decreases the
expiratory pressure according to the range set by the user.

You need to set the following parameters for the Adaptive EPAP function.

1. [AE]: Switch of adaptive EPAP


2. [EPAPmin]: Minimum expiratory pressure limit of adaptive EPAP function
3. [EPAPmax]: Maximum expiratory pressure limit of adaptive EPAP function

6.6.4 Pressure Relief


After the pressure relief function is activated, the ventilator decreases the target expiratory pressure
for a period of time at the beginning of expiration and returns to the preset expiratory pressure
before inspiration. The greater the pressure relief level, the more the pressure decreases.

You need to set the following parameters for the pressure relief function.

1. [P-Flex]: Pressure relief level

6.6.5 EasySync™
EasySync™ synchrony enhancement technology enables patient-ventilator synchrony in the
inspiratory and expiratory triggering phases, covering the entire ventilation cycle phase. This
technology combines the characteristics of the patient's respiratory system to adjust parameters of
[Trigger] and [E-Cycle], reducing the frequently adjustment of ventilator settings during ventilation,
alleviating the workload of medical staff and improving the patient ventilator synchrony.

Operator’s Manual of Ventilator 6 - 17


Ventilation Additives Start Ventilation

The synchrony of inspiratory trigger refers to the ventilator, which is under the ventilation mode with
[Trigger], the allowance of inspiratory trigger and the startup of EasySync™, can trigger inspiration
according to real time monitoring patient inspiratory effort by waveform analysis. It can reduce the
triggering delay, the work of triggering, ineffective triggering and auto triggering.

The synchrony of expiratory trigger refers to the ventilator, which is under the ventilation mode with
[E-Cycle] and the startup of EasySync™, when the synchronous enhancement function is enabled,
monitors the patient's expiratory effort according to the waveform characteristics in real time and
triggers expiration. It can improve the synchronization of expiration switching, and reduce the time
of premature or delayed termination.

WARNING: Please assess the intensity of patient’s spontaneous breathing before


use. For patients with weak spontaneous breathing, continuous
ineffective triggering will make the ventilator enter backup ventilation
mode.

6.6.6 Ramp
The Ramp function is to increase the inspiratory pressure or expiratory pressure to the target pressure
within the preset time to improve the comfort of the patient's first use of the ventilator.

1. Select [Ramp] button.


2. Set [Tramp], [Initial Insp. P] (not required in CPAP mode) and [Initial Exp. P].
3. If the ventilator is in Standby mode, select [Start In Ventilation] and the [Ramp] key stays
illuminated. Select the [Start Ventilation] button in the interface or the system recognizes a
patient wearing mask. The system will ventilate the patient according to the settings. After
entering the ventilation mode, the Ramp function is enabled.
4. If the ventilator is in Standby mode, select [Start] and the [Ramp] key stays illuminated, and the
Ramp function is enabled.
5. When the function is enabled, the countdown time is displayed on the [Ramp] button. The
actual target pressure gradually increases from the initial pressure level to the target pressure set
by the user in the ventilation mode.
6. To exit the Ramp function:
• Select [Ramp] and [End Ramp] to exit the Ramp function.
• Select the [Standby] key to enter the Standby interface and exit the Ramp function.

Pressure

Tramp IPAP EPAP


Initial Insp. P

Initial Exp. P Time

FIGURE 6-13 Ramp

6 - 18 Operator’s Manual of Ventilator


Start Ventilation Alarm Limit Setup

6.7 Alarm Limit Setup


Select the [Alarms] key to set the ventilation alarm limit and module alarm limit in the interface that
appears. Apart from this, you can also view recent alarms and current alarms. For more details, see
(page 10-4) 10.6 “Set Alarm Limits”.

6.8 Start Ventilation


WARNING: Before using the ventilator on a patient, check whether the oxygen
concentration in the delivered gas is consistent with the setting value.

WARNING: Adopt manual ventilation immediately if the ventilator has


malfunctions and cannot continue ventilating the patient.

1. Set the patient information in Standby mode.


2. Select mask or intubation.
3. Select whether to connect the exhalation port. If needed, perform exhalation port calibration.
4. Set the ventilation mode.
5. Set alarm limits.
6. Select the [Start Ventilation] button in the interface or the system recognizes a patient wearing
mask. The system will ventilate the patient according to the settings.

Operator’s Manual of Ventilator 6 - 19


Ventilation Parameters Start Ventilation

6.9 Ventilation Parameters


WARNING: According to the relevant laws and regulations, oxygen concentration
should be monitored when the equipment is used on the patient. If the
ventilator is not configured with such a monitoring function or this
function is switched off, use a monitor which complies with ISO 21647
for oxygen concentration monitoring.

NOTE: All the parameters are calculated based on the real-time flow and
pressure waveform data. For real-time flow and pressure data, low pass
filter is adopted at an original sampling rate of 1 KHz and cut-off
frequency of 20 Hz.

NOTE: The calculating parameters related to flow calculations shown on the


ventilator are in the BTPS condition.

SETTING
PARAMETERS DESCRIPTION
O2% The volume percentage of oxygen in the gas mixture supplied to the
patient.
CPAP Pressure is maintained in the pressure-controlled mode.
IPAP The inspiratory pressure in the pressure-controlled mode is an absolute
value.
Psupp Support pressure in the pressure-controlled mode is an absolute value.
Pbackup Inspiratory pressure in the backup ventilation mode is an absolute value.
EPAP Expiratory pressure level.
TV The volume of gas that the patient inhales or exhales during resting
breathing.
Flow Flow rate delivered to the patient in O2 therapy mode.
f Number of mechanical breaths per minute.
fbackup Breathing frequency set in backup ventilation mode.
Tinsp Inspiratory time in one breathing cycle.
Pmin Minimum inspiratory pressure limit.
Pmax Maximum inspiratory pressure limit.
TVmax Maximum volume of gas that the patient is allowed to inhale or exhale
during resting breathing.
PPV% Proportional ventilation percentage based on the patient inspiratory
efforts.
Max E Patient's pulmonary elastance.
Max R Patient's airway viscous resistance.
EPAPmin Minimum expiratory pressure limit in the Adaptive EPAP function.
EPAPmax Maximum expiratory pressure limit in the Adaptive EPAP function.
Tramp Set the time interval for the pressure delay to rise to the target pressure.
Tslope Speed at which the airway pressure rises to the target pressure. The
higher the value is, the slower the pressure rises.
Trigger Trigger sensitivity. The larger the value, the more sensitive the trigger.
E-Cycle Expiratory cycle sensitivity. The larger the value, the more sensitive the
trigger.

6 - 20 Operator’s Manual of Ventilator


Start Ventilation Enter Standby Mode

P-Flex Pressure relief level setting during switching phase. The greater the value
is, the more the pressure relieves.
AE Switch of Adaptive EPAP function.

MONITORED
PARAMETERS DESCRIPTION
FiO2 The percentage of oxygen in the patient's inspired gas.
Ppeak The maximum pressure value in one breathing cycle.
PEEP Positive end-expiratory pressure.
PEEPi The end-expiratory intrapulmonary pressure minus the airway pressure
(the PEEPi displayed on the ventilator does not include PEEP).
TVe Expiratory tidal volume in one cycle.
TVe/IBW Delivered tidal volume per ideal body weight.
MVe The accumulated expired tidal volume in one minute.
ftotal The accumulated number of breaths in one minute.
Pt.leak Accumulated patient leakage volume in one minute (excluding the
active leakage caused by the mask and exhalation port).
Tot.leak Total leakage volume in one minute.
Pt.Trig This parameter specifies the percentage of patient-triggered cycles
within one minute.
Ti/Ttot The ratio of the inspiratory time to the total time.
PEF The maximum expiratory flow of the patient in the expiratory phase.
ROX ROX index, ROX= (SpO2/FiO2)/fspn.
PtpI Transpulmonary pressure at the end of inspiratory phase.
PtpE Transpulmonary pressure at the end of expiratory phase.
ΔPtp ΔPtp = PtpI - PtpE.
PesI Oesophageal pressure at the end of inspiratory phase.
PesE Oesophageal pressure at the end of expiratory phase.
ΔPes Wobble value of oesophageal pressure at the end of inspiratory phase.
PTPes Oesophageal pressure time product of 1 breath. It indicates the patient's
inspiratory effort.
PTPes/min The accumulation of PTPes in one minute.
EtCO2 The concentration of CO2 measured at the end of expiration.
SpO2 Oxygen saturation (SpO2).
PR Pulse frequency.
PI Perfusion index.

TABLE 6-1 Ventilation Parameters

6.10 Enter Standby Mode


Select the [Standby] key and enter the Standby interface after confirmation.

WARNING: Ensure that an alternative ventilation option is available for the patient
and no patient is connected to the ventilator before putting the
equipment to the Standby mode to prevent patient injury due to lack of
ventilatory support.

Operator’s Manual of Ventilator 6 - 21


Power off System Start Ventilation

WARNING: Turn off the humidifier before putting the ventilator to the Standby
mode to prevent patient injury or damage to the patient tubing due to
overheated gas.

6.11 Power off System


When the ventilator is in the Standby mode, press the hard key to power off the ventilator system.

When the ventilator is in a non-Standby mode, select the hard key and the system will prompt
[Please enter Standby mode to shut down the system.]. Select [Ok] and the system will remain in the
non-Standby mode. Then select the [Standby] key and enter the Standby interface after confirmation.
Select the hard key again to power off the ventilator system.

6 - 22 Operator’s Manual of Ventilator


7.0 CO2 Monitoring

Overview ........................................................................................................................................................................................................7-2
Prepare for Measurement....................................................................................................................................................................7-3
CO2 Setup .....................................................................................................................................................................................................7-4
Influencing Factors of Measurement ...........................................................................................................................................7-5
Troubleshooting........................................................................................................................................................................................7-6
Zero the Sensor..........................................................................................................................................................................................7-6
Calibrate the Sensor................................................................................................................................................................................7-6

Operator’s Manual of Ventilator 7-1


Overview CO2 Monitoring

7.1 Overview
The CO2 module configured for the ventilator adopts the infrared (IR) absorption technology to
measure the CO2 concentration in the patient’s airway. The principle is based on the CO2 molecule’s
ability to absorb IR light of a specific wavelength. The amount of absorbed light is directly related to
the CO2 concentration. When the IR light emitted by the infrared source penetrates through the gas
samples containing CO2, part of IR light will be absorbed by the CO2 molecules in the gas. Use a
photodetector on the other side of the IR light source to measure the remaining energy of the IR light
and convert it into an electrical signal. After comparing and adjusting the energy of the electrical
signal and the IR light source, the photodetector can accurately reflect the CO2 concentration in the
gas sample.

The rated respiration rate range of CO2 module is 0 to 150 bpm, and the data sample rate is 100 Hz.
Besides, the EtCO2 concentration reading uses the maximum value of the CO2 waveform
corresponding to the respiratory cycle.

To measure the rated respiration rate range, utilize a valve to switch between two sampling gases at
different frequencies (simulating specified respiration rates) and record the EtCO2 values for the
specific frequencies. By drawing the coordinate diagram which indicates the corresponding
relationship between end tidal value and breathing frequency, the range of breathing frequency of
EtCO2 measurement accuracy complying with the specification can be obtained.

The CO2 module of this ventilator are configured with automatic atmospheric pressure
compensation function.

1 2

FIGURE 7-1 CO2 Graphic Trend, Waveform and Monitoring Parameters

The CO2 measurement provides as follows.

1. CO2 graphic trend: records the trend of parameter value changes at specified time and
describes the change of CO2 measurement results with a curve.

7-2 Operator’s Manual of Ventilator


CO2 Monitoring Prepare for Measurement

2. CO2 waveform.
3. End-tidal CO2 (EtCO2) concentration: the CO2 concentration measured at the end of the
expiration phase.

WARNING: Please ensure the cardiopulmonary condition is stable to get the most accurate CO2
measurement result.

NOTE: CO2 cannot be measured in the aerosol drug environment. Power off
the monitoring function of the CO2 module during nebulization.

NOTE: As required by the international laws and regulations, it is


recommended that CO2 concentration should be monitored when the
equipment is used on the patient. If your equipment is not configured
with this function, use a monitor compliant with the requirements of
corresponding international standards for CO2 concentration
monitoring.

7.2 Prepare for Measurement


1. Install the watertrap to the watertrap fixer and then connect the CO2 watertrap with the CO2
sampling line. [CO2 Startup] is displayed on the screen.

CO2 watertrap

Watertrap
fixing seat

Sampling
line

FIRURE7-2 Preparation for CO2 Measurement

2. After start-up is finished, the [CO2 Warm-up] message is displayed. The CO2 module is in ISO
accuracy mode. If you perform CO2 measurements during warm-up, the measurement accuracy
may be compromised.
3. After warm-up is finished, the module enters full accuracy mode.

CAUTION: The CO2 watertrap is used to collect water drops condensed in the
sampling line to prevent water drops from entering the module. When
the water collected reaches a certain amount, pour it out to avoid
blocking the airway. Dispose of accumulated fluids in accordance with
the hospital policy or local regulations.

CAUTION: The CO2 watertrap contains filter material to prevent bacterium, vapor
and patient secretions from entering the module. After a long-term use,
dust or other substances reduce the permeability of the filter material
in the watertrap, and even block the airway. In this case, replace the
CO2 watertrap. Replacing it once a month is recommended. Or, replace
the it when it is detected leaky, damaged or contaminated.

Operator’s Manual of Ventilator 7-3


CO2 Setup CO2 Monitoring

NOTE: When the CO2 monitoring function is not used, it is recommended not
to connect a CO2 watertrap, and set the CO2 module to standby mode to
extend the service life of the watertrap and module.

NOTE: It takes approximately two minutes from powering on the ventilator to


achieving the sidestream CO2 monitoring performance specified in
(page B-10) B.10 “CO2 Module” of this manual.

NOTE: Using specific accessories, the sidestream CO2 measurement module


can be applied to adult and pediatric patients undergoing intubation
or non-invasive ventilation. For patient with intubation, it can draw the
gas from the patient tubing through the airway adapter and gas
sampling line.

NOTE: The gas sampled by the sidestream CO2 module of this ventilator is a
mixture of air and oxygen, and the gas can pass through the gas outlet
into the operating environment.

NOTE: Observe related biohazard regulations when disposing of CO2


watertraps and sampling lines.

NOTE: The vent of the CO2 module is used to discharge the sample gas. Do not
block it.

NOTE: Before measurement, use 3% to 7% standard CO2 gas to connect to the


CO2 sampling line for functional test.

7.3 CO2 Setup


7.3.1 Set CO2 Monitoring
Select [Menu] → [Setup] → [CO2]. When [Monitoring] is set to (ON), the CO2 module enters the
operating mode. The ventilator displays CO2 parameters and waveforms, and provides physiological
alarms and technical alarms related to the CO2 module. When [Monitoring] is set to (OFF), the
CO2 module enters standby mode. The ventilator does not display CO2 parameters and waveforms,
or provide physiological alarms related to the CO2 module.

The standby mode of CO2 module is relevant to the Standby status of ventilator:

• If the ventilator enters Standby status, the CO2 module also enters standby mode.
• If the ventilator exits Standby status, the CO2 module is restored to the CO2 operating mode
before standby mode.
• The CO2 module entering or exiting the Standby mode do not impact the ventilator.
To manually enter or exit the Standby mode, select [Menu] → [Setup] → [CO2] and set [Monitoring]
to (OFF) or (ON).

In standby mode, the working components of the CO2 module, such as gas pump and infrared light
source, are automatically turned off to extend the service life of the module.

7.3.2 Set BTPS Compensation


The CO2 measurement provides:

1. ATPD: Ambient Temperature and Pressure, Dry Gas;

7-4 Operator’s Manual of Ventilator


CO2 Monitoring Influencing Factors of Measurement

2. BTPS: Body Temperature and Pressure, Saturated.


The CO2 readings will be relatively higher in the presence of moisture. Therefore, the module will use
different formulas for each situation to calculate the partial pressure of CO2:

ATPD: Pco 2 (mmHg ) = CO2 (vol %) × Pamb / 100

PCO 2 (mmHg ) = CO2 (vol %) × ( Pamb − 47) / 100


BTPS:

Where:
PCO 2 = CO2 partial pressure, vol % = CO2 concentration, Pamb = ambient pressure,
and the unit is in mmHg.

For CO2 module, BTPS compensation is switched on or off based on the actual situations. The settings
method is as follows:

1. Select [Menu] → [Setup] → [CO2].


2. Set [BTPS Comp] to (ON) or (OFF) in BTPS or ATPD.

7.3.3 Set Null for 30s from Zeroing


1. Select [Menu] → [Setup] → [CO2].
2. Set [Null for 30s from zeroing]: (ON) or (OFF). When the setting is (ON), related
parameters of CO2 module will be invalid within 30s of starting zeroing CO2 module. When the
setting is (OFF), related parameters of CO2 module will be normal within 30s of starting
zeroing CO2 module.

7.3.4 Set CO2 Unit


To change the CO2 unit:

1. Select [Menu] → [System] → enter the system password → [Setup] → [Language/Unit].


2. Set [CO2 Unit]: [mmHg], [kPa] or [vol.%].

7.4 Influencing Factors of Measurement


Measurement accuracy may be compromised due to:

• Leakage or internal leakage of the sample gas;


• Mechanical shock;
• Cyclic pressure which is greater than 10 kPa (100 cmH2O);
• Other interference sources (if available).
Measurement accuracy may be affected by the breath rate and I/E ratio as follow.

• When EtCO2 is within specification for breath rate ≤60 /min and I/E ratio ≤1:1, the precision
of the EtCO2 measurement meets the defined specification.
• When EtCO2 is within specification for breath rate ≤30 /min and I/E ratio ≤2:1, the precision
of the EtCO2 measurement meets the defined specification.

Operator’s Manual of Ventilator 7-5


Troubleshooting CO2 Monitoring

7.5 Troubleshooting
When the sampling system of the CO2 module works abnormally, check if the sampling line is kinked.
If not, remove the sampling line from the CO2 watertrap. If a prompt message indicating airway
malfunction appears on the screen, it means that the CO2 watertrap is occluded. In this case, you
must replace the CO2 watertrap. If no such prompt message is displayed, it means that the sampling
line is occluded. Then you must replace the sampling line.

7.6 Zero the Sensor


Zeroing the sensor aims to eliminate the effect of baseline drift on the readings during the
measurement, so as to ensure measurement accuracy.

For CO2 module, a zero calibration is carried out automatically if necessary. You can also start a
manual zero calibration when it is necessary. In Standby mode, select [Menu] → [Calibration] →
[CO2 Maintenance], and then select [Zero] button. It is unnecessary to disconnect the senor from the
breathing system when performing the zeroing.

7.7 Calibrate the Sensor


The CO2 module does not require daily validation, but may require calibration once a year or when
the measured value has a great deviation. For more details, see (page 12-1) 12.0 “Maintenance”.

7-6 Operator’s Manual of Ventilator


8.0 SpO2 Monitoring

Overview ........................................................................................................................................................................................................8-2
Safety Information....................................................................................................................................................................................8-3
Monitoring Steps ......................................................................................................................................................................................8-3
SpO2 Setup...................................................................................................................................................................................................8-4
Influencing Factors of Measurement ...........................................................................................................................................8-4

Operator’s Manual of Ventilator 8-1


Overview SpO2 Monitoring

8.1 Overview
SpO2 monitoring is a non-invasive technique, used to measure the amount of oxygenated
haemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The light
generated in the sensor passes through the tissue and is converted into electrical signals by the
photodetector in the sensor. The SpO2 module processes the electrical signal and displays a
waveform and digital values for SpO2 and pulse rate.

This device is calibrated to display functional oxygen saturation.

FIGURE 8-1 SpO2 Waveform and Monitoring Parameters

1. Pleth waveform (Pleth): visual indication of patient’s pulse. The waveform is not normalized.

NOTE: Incomplete signals may trigger related low-level alarms.

2. Pulse rate (PR): detected pulsations per minute.


3. Perfusion index (PI): gives the numerical value for the pulsatile portion of the measured signal
caused by arterial pulsation. PI is an indicator of the pulsatile strength. You can also use it to
assess the quality of SpO2 measurement. It is optimal if PI is greater than 1, is acceptable if PI is
between 0.3 and 1, and indicates low perfusion if PI is smaller than 0.3. In low perfusion, the
probe should be adjusted, or a better perfusing site should be selected. If low perfusion persists,
choose another method to measure oxygen saturation if possible.
4. Perfusion indicator: the pulsatile portion of the measured signal caused by arterial pulsation.
5. Pulse oxygen saturation (SpO2): percentage of oxygenated hemoglobin in relation to the sum of
oxyhemoglobin and deoxyhemoglobin.

NOTE: Mindray SpO2 interface can only be connected to a Mindray SpO2


extension cable.

NOTE: A functional tester or SpO2 simulator cannot be used to assess the


accuracy of a SpO2 module or a SpO2 sensor.

NOTE: A functional tester or SpO2 simulator can be used to assess the pulse
rate accuracy.

8-2 Operator’s Manual of Ventilator


SpO2 Monitoring Safety Information

NOTE: SpO2 simulators cannot be used to validate the accuracy of pulse


oximeters or SpO2 sensors. The accuracy of pulse oximeters and SpO2
sensors should be validated with clinical data.

NOTE: Qualification and compliance testing in line with YY 0784-2010 should


be conducted for the ventilator, as well as the SpO2 probe and the
probe extension cable that are intended to be used together with this
ventilator.

8.2 Safety Information


WARNING: Use only SpO2 sensors and cables specified in this manual. Follow the
SpO2 sensor’s instructions for use and adhere to all warnings and
cautions.

WARNING: When a trend toward patient deoxygenation is indicated, blood


samples should be analyzed by a blood gas analyzer to completely
understand the patient’s condition.

WARNING: Do not use SpO2 sensors when an MRI device is in use because the
induced current may seriously burn the patient.

WARNING: When monitoring the patient for a long period of time, check the
position of the SpO2 sensor every 2 hours and move it properly when
the skin changes or every 4 hours. Some patients may require more
frequent examinations, such as newborns, patients with impaired
perfusion, or patients with sensitive skin. Prolonged continuous
monitoring may increase unpredictable skin changes such as allergy,
reddening, blistering or pressure necrosis.

WARNING: Check whether the SpO2 probe is intact before use. If it is damaged, do
not use it. Otherwise, patient injury may occur.

WARNING: Please check the compatibility of the ventilator, SpO2 sensor and probe
extension cable before use to avoid injuries to patients. Otherwise,
patient injury may occur.

8.3 Monitoring Steps


1. Select appropriate SpO2 sensors based on the patient’s weight.
2. Clean the application site, such as colored nail polish.
3. Place the SpO2 sensor on the patient (see the user manual of the SpO2 sensors for specific
locations).
4. Connect the extension cable to the SpO2 connector on the ventilator.
5. Connect the SpO2 sensors to the extension cable.

Operator’s Manual of Ventilator 8-3


SpO2 Setup SpO2 Monitoring

8.4 SpO2 Setup


8.4.1 Set SpO2 Monitoring
Select [Menu] → [Setup] → [SpO2] and set [Monitoring] to (ON) or (OFF).

8.4.2 Set Sensitivity


Select [Menu] → [Setup] → [SpO2] and set [Sensitivity] to [High], [Med] or [Low]. When the
sensitivity is set to [High], the ventilator is more sensitive to identify small signals. When the ventilator
is used on a critically ill patient who has very weak pulses, the sensitivity should be set to [High].
When the ventilator is used on a non-critically ill patient, movements of the patient may produce
noise or invalid small signals, and the sensitivity should set to [Med] or [Low] to filter the interference
caused by movements and ensure stable measurement.

8.4.3 Set Pulse Volume


Select [Menu] → [Setup] → [SpO2] to adjust the pulse volume in the interface that appears.
indicates the lowest volume, indicates the highest volume, and indicates that the volume is
turned off.

8.4.4 Set Sweep Speed


Select [Menu] → [Setup] → [SpO2] to set [Sweep Speed] to [12.5 mm/s] or [25 mm/s].

8.5 Influencing Factors of Measurement


If you are unsure of the accuracy of measurement results, please examine the patient's vital signs
using other methods, and then examine the ventilator and the SpO2 sensors. During the
measurement process, the following factors may impact the measurement accuracy:

• Ambient light
• Physical movement (active or passive movement of patient)
• Diagnostic testing
• Low perfusion
• Electromagnetic interference, such as MRI device
• Electrosurgical device
• Dysfunctional haemoglobin, such as carboxyhemoglobin (COHb) and methemoglobin (MetHb)
• Presence of certain dyes, such as methylene and indigo carmine
• Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2 sensor
• Drop of arterial blood flow to immeasurable level caused by shock, anemia, low temperature or
vasoconstrictor.

8-4 Operator’s Manual of Ventilator


9.0 Special Functions

O2 ↑ ...................................................................................................................9-2
Auxiliary Pressure ......................................................................................................................................................................................9-2

Operator’s Manual of Ventilator 9-1


O2 ↑ Special Functions

9.1 O2 ↑
O2 ↑ refers to ventilating a patient with the O2% higher than the normal level within a period of
time.

Choose [Menu] → [Setup] → [Ventilation] to set [Increase O2% during O2 ↑ ].

Press the [O2 ↑ Flush] key, and the ventilator starts oxygen enrichment. At this time, the [O2 ↑
Flush] key displays the remaining oxygen enrichment time. O2 ↑ can be active for a maximum of
two minutes. During oxygen enrichment, the currently set oxygen concentration is displayed in the
[O2%] parameter setup shortcut key field.

When the two-minute period of oxygen enrichment is up or the [O2 ↑ Flush] key is pressed again,
the ventilator terminates oxygen enrichment.

NOTE: O2 ↑ (Oxygen enrichment) is disabled in Standby or O2 therapy mode.

NOTE: When O2 supply type is low-pressure, pressing the [O2 ↑ Flush] key
will not activate oxygen enrichment, and the prompt message [Fail to
Start with Low Pressure O2 Supply] will be displayed.

NOTE: When the [O2 Supply Failure] alarm is triggered, pressing the [O2 ↑
Flush] key will not activate oxygen enrichment, and the prompt
message [Fail to Start. O2 Supply Failure.] will be displayed.

NOTE: If the [O2 Supply Failure] alarm is triggered during the O2 ↑ process,
the O2 ↑ function will be terminated.

9.2 Auxiliary Pressure


Auxiliary pressure function is external pressure monitoring function provided by the ventilator. By
connecting the external pressure sampling accessory with ventilator's auxiliary pressure
measurement connector, the ventilator can monitor and display related pressure monitoring
parameters. Refer to the instructions accompanying the auxiliary pressure accessory for connection
and usage.

NOTE: The contraindications of auxiliary pressure monitoring accessories in


clinical use are the same as those of gastric catheter, including
uncontrolled coagulopathy;
serious plateletpenia;
nasal traumas;
esophageal varices;
esophageal ulcer/tumor;
diverticulitis;
patients who have just undergone nasopharyngeal, esophageal, or
gastric surgery;
sinusitis, epistaxis, etc.

NOTE: Refer to the instructions for auxiliary pressure monitoring accessories.

9-2 Operator’s Manual of Ventilator


Special Functions Auxiliary Pressure

9.2.1 Connect Auxiliary Pressure Monitoring Accessories

FIGURE 9-1 Install Auxiliary Pressure Monitoring Accessories (Gastric Tube with Balloon)

A. Auxiliary pressure measurement connector


B. Esophageal balloon extension tube
C. Esophageal balloon
Installation steps:

1. Refer to the instructions of accessories to assemble the accessories.


2. Connect the esophageal pressure extension tube to the ventilator's auxiliary pressure
measurement connector.
3. Select [Paux], and set [Paux(Pes)] to (ON) in the interface that appears.

9.2.2 Turn on or off Auxiliary Pressure


Select [Paux], and set [Paux(Pes)] to (ON) or (OFF) in the interface that appears.

9.2.3 Zero Auxiliary Pressure


1. Auxiliary pressure measurement connector is open to the air.
2. Select [Paux], and press [Start] to start zeroing the auxiliary pressure.

Operator’s Manual of Ventilator 9-3


Auxiliary Pressure Special Functions

This page intentionally left blank.

9-4 Operator’s Manual of Ventilator


10.0 Alarms

Introduction .............................................................................................................................................................................................. 10-2


Alarm Types............................................................................................................................................................................................... 10-2
Alarm Priority............................................................................................................................................................................................ 10-2
Alarm Signals............................................................................................................................................................................................ 10-2
Set Alarm Volume.................................................................................................................................................................................. 10-4
Set Alarm Limits...................................................................................................................................................................................... 10-4
AUDIO PAUSED....................................................................................................................................................................................... 10-5
Current Alarm........................................................................................................................................................................................... 10-5
Recent Alarms.......................................................................................................................................................................................... 10-6
Recent Alarms.......................................................................................................................................................................................... 10-6
ALARM OFF................................................................................................................................................................................................ 10-6
Alarm Tests................................................................................................................................................................................................. 10-6
Nurse Call................................................................................................................................................................................................. 10-10
Responses to Alarms......................................................................................................................................................................... 10-10

Operator’s Manual of Ventilator 10 - 1


Introduction Alarms

10.1 Introduction
Alarms refer to the alerts provided by the ventilator to health care professionals in sounds or other
forms when the patient that the ventilator is used on suffers an exceptional change in vital signs, or
when the ventilator suffers a fault that prevents its proper functioning.

WARNING: A potential 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 room.

NOTE: The system checks whether alarm tones and alarm lamps function
properly during the start-up of the ventilator. If they function properly,
the alarm indicator flashes yellow and red once in turn, and the speaker
and buzzer sound the system check tone respectively. Otherwise, do
not use the equipment and contact the Customer Service Department
immediately.

NOTE: When multiple alarms of different priorities occur simultaneously, the


ventilator selects the alarm of the highest priority and gives visual and
audible alarm indications accordingly.

NOTE: If more than one alarm of the same level are triggered simultaneously,
the alarm messages will be displayed in the sequence of alarms
triggered.

10.2 Alarm Types


The ventilator's alarms can be divided into physiological alarms, technical alarms and prompt
messages by nature.

• Physiological Alarms:
A physiological alarm is usually triggered when a physiological parameter value of the patient
exceeds the preset alarm limits, or the patient suffers a physiological abnormality. Physiological
alarm messages are displayed in the alarm message field on the screen.
• Technical Alarms:
A technical alarm, also called system error message, is triggered when a system function fails or
the monitoring result presents distortion because of improper operation or system faults.
Technical alarm messages are displayed in the alarm message field on the screen.
• Prompt messages:
Strictly speaking, prompt messages are not alarms. They are the messages about the system
status apart from physiological and technical alarms, and prompt messages usually do not
involve the patient's vital signs. Prompt messages are displayed in the prompt message field on
the screen.

10.3 Alarm Priority


The ventilator's alarms can be divided into high priority alarms, medium priority alarms and low
priority alarms by severity. The priorities for all alarms are preset before the ventilator leaves the
factory and are not user adjustable.

10.4 Alarm Signals


When an alarm is triggered, the ventilator will alert the user through the following visual or audible
alarm signals:

10 - 2 Operator’s Manual of Ventilator


Alarms Alarm Signals

• Alarm lamps
• Audible alarms
• Alarm messages
• Flashing parameters
Specifically, alarm lamps, audible alarms and alarm messages distinguish the priority of alarm in
different ways.

10.4.1 Alarm Lamps


When a technical alarm or a physiological alarm is triggered, the alarm indicator indicates different
alarm priorities by color and flashing frequency.

• High priority alarm: The indicator flashes red quickly.


• Med priority alarm: The indicator flashes yellow slowly.
• Low priority alarm: The indicator is always yellow without flashing.

10.4.2 Audible Alarms


The ventilator plays different alarm tones to indicate different alarm priorities.

• High priority alarm: The high priority alarm tone is played.


• Med priority alarm: The medium priority alarm tone is played.
• Low priority alarm: The low priority alarm tone is played.
A-weighted sound pressure level of audible alarm signals:

• Position of the operator: 1 meter in front of and 1.5 meters above the ventilator.
• A-weighted sound pressure level: not less than 45 dB and not greater than 85 dB. The high
priority alarm volume is not less than 60 dB at the default alarm volume.

10.4.3 Alarm Messages


Alarm messages are displayed in the alarm message field of the ventilator when an alarm is triggered.
The system uses different background colors to distinguish priorities of alarm messages:

• High priority alarm: red


• Med priority alarm: yellow
• Low priority alarm: yellow
The following symbols are displayed before alarm messages to distinguish priorities of alarm
messages:

• High priority alarm: !!!


• Med priority alarm: !!
• Low priority alarm: !

10.4.4 Flashing Alarm Parameters


When the value of a monitoring parameter exceeds the alarm limits, the parameter will flash at a
certain frequency.

10.4.5 Alarm Status Icon


Apart from the above alarm methods, the screen will also show the following alarm status icons to
indicate different alarm status.

Operator’s Manual of Ventilator 10 - 3


Set Alarm Volume Alarms

• : Indicates that the alarm tone is paused and the alarm system is in the AUDIO PAUSED
state.
• : When the number of alarms is displayed before an alarm message, it indicates that
multiple alarm messages exist. The system uses different background colors to distinguish
priorities of alarm messages: The red color indicates that the highest priority of the multiple
alarm messages is high priority, and the yellow color indicates that the highest priority of
the multiple alarm messages is medium priority. You can view active alarms by selecting the
alarm message field.
• : Indicates that there is an inactivated alarm for which the alarm triggering condition has
disappeared. Tap the icon and you can view the recent inactivated alarms in the interface
that appears. Or you can select the [Reset] key to clear recent inactivated alarms.
• : Indicates that the alarm of a parameter has been turned off and the alarm signal is in
the ALARM OFF state.

10.5 Set Alarm Volume


To set alarm volume:

1. Select [Alarms] button → [Audio].


2. Set [Alarm Volume]: indicates the lower volume, indicates the higher volume. Alarm
volume is limited by the lowest volume and cannot be lower than the lowest one. If there are no
current alarms, the system will play the low priority alarm tone once at your set alarm volume
when you adjust the volume.
To set minimum alarm volume:

1. Select [Menu] → [System] → enter the system password → [Setup] → [Language/Unit].


2. Set [Minimum Alarm Volume] to a proper volume. indicates the lower volume and
indicates the higher volume.

WARNING: Do not rely exclusively on the audible alarm system when using the
ventilator. Setting the alarm volume to a low level may result in a
hazard to the patient. Always keep an eye on the patient's actual
clinical situations.

10.6 Set Alarm Limits


CAUTION: If the clinical conditions do not require setting the high pressure alarm
limit greater than 50 cmH2O, it is recommended to set it to 50 cmH2O or
smaller to extend the service life of the turbine and increase the
operating time of the battery.

NOTE: An alarm will be triggered when a parameter value is higher than the
high alarm limit or lower than the low alarm limit.

NOTE: During equipment use, pay frequent attention to the alarm limits of
parameters to ensure that they are appropriately set.

Select [Alarms] → [Vent Limits], [Module Limits] or select the monitored value that flashes because of
an alarm to open the alarm limits setup menu and set the ventilation and module related alarm
limits.

10 - 4 Operator’s Manual of Ventilator


Alarms AUDIO PAUSED

10.7 AUDIO PAUSED


10.7.1 Set AUDIO PAUSED
Press the [Audio Pause] key to enable the AUDIO PAUSED state which lasts 120 seconds. The action
can mute the current alarm tones. When the 120-second countdown is over, the system will exit the
AUDIO PAUSED state and resume audible alarms.

WARNING: Pay close attention to the patient and ventilator to ensure that no alarm
messages are overlooked during the AUDIO PAUSED period. When the
alarm triggering condition remains for long without any
countermeasures taken, the patient or equipment may be subject to
hazards.

NOTE: In the AUDIO PAUSED state, all the other alarm methods function
properly except audible alarms.

NOTE: In the AUDIO PAUSED state, if a new technical or physiological alarm is


triggered, the new alarm will trigger audible alarm and the old alarm
will be muted after 120 seconds or become normal by repressing the
AUDIO PAUSE button.

NOTE: After exiting the Standby mode, the system automatically enters the
AUDIO PAUSED state and alarms are muted for 30 seconds.

10.7.2 Cancel AUDIO PAUSED


In the AUDIO PAUSED state, when the [Audio Pause] key is pressed, the AUDIO PAUSED icon and
countdown timer on the screen will disappear.

10.8 Current Alarm


When the system has current alarms, the number of alarms displayed before the alarm message
indicates that multiple current alarm messages exist. Select the alarm message field, and you can
view the current alarm messages, alarm time, alarm durations and alarm priorities in the pop-up
alarm menu. For some alarms, you can select the triangle button on the right side to view related
help information.

A B C

FIGURE 10-1 Help Information

Operator’s Manual of Ventilator 10 - 5


Recent Alarms Alarms

A. Duration of alarm message


B. Alarm priority level
C. Alarm message
D. Help information soft key
Select this soft key to display help information in the opened interface. Select this soft key
again to close the interface.
E. Help information
F. Associated information
Select the key to open the corresponding settings menu.

10.9 Recent Alarms


When there exists an inactivated alarm for which the alarm triggering condition has disappeared, the
icon is displayed. Tap the icon to view the recent inactivated alarms in the recent alarms
menu, or you can select the [Reset] key to clear recent inactivated alarms.

10.10 ALARM OFF


When alarm limits are set to [OFF] or when alarms are blocked, the system will display the icon in
the alarm limits area of the parameter, and the corresponding physiological alarms will be disabled.
That is, the alarm message, alarm lamp, audible alarm and flashing parameters for the physiological
alarm will be disabled.

WARNING: Switching off alarms can endanger the patient. Handle with care.

10.11 Alarm Tests


10.11.1 Battery in Use
1. Connect the ventilator to the external power supply and press the hard key.
2. Disconnect the external power supply after the system starts up.
3. Verify that the [Battery in Use] alarm is activated and the ventilator is powered by batteries.
4. Reconnect the external power supply.
5. Verify that the alarm resets and the ventilator is again powered by external power supply.

10.11.2 Loss of Power


1. Connect the ventilator to the external power supply and press the hard key.
2. After the system starts up, disconnect the external power supply when the battery is fully
charged.
3. Connect a test lung to the ventilator and start normal ventilation.
4. The ventilation time is around 180 minutes for the ventilator with one battery. (The ventilation
time is around 360 minutes for the ventilator with two batteries.) When the battery runs low, the
loss of power alarm [System DOWN. Connect Ext. Power.] will be triggered.
5. Reconnect the external power supply.
6. Verify that the alarm resets and the ventilator is again powered by the external power supply.

10 - 6 Operator’s Manual of Ventilator


Alarms Alarm Tests

10.11.3 Paw Too High


1. After the ventilator system is started normally, connect the ventilator to a test lung and start
ventilation.
2. Set Paw high alarm limit to current Peak+5 cmH2O.
3. Squeeze the test lung hard in the inspiratory phase.
4. Verify that the [Paw Too High] alarm has been activated and that the respiratory cycle enters the
expiratory phase. The Paw falls to the EPAP level.

10.11.4 Paw Too Low


1. After the ventilator system is started normally, connect the ventilator to a test lung and start
ventilation.
2. Set the Paw low limit to the current Ppeak +5 cmH2O.
3. Verify that the [Paw Too Low] alarm has been activated.

10.11.5 TVe Too Low


1. After the ventilator system is started normally, connect the ventilator to a test lung and start
ventilation.
2. Set the TVe low alarm limit to be greater than the current TVe. Verify that the [TVe Too Low]
alarm is activated.

10.11.6 TVe Too High


1. After the ventilator system is started normally, connect the ventilator to a test lung and start
ventilation.
2. Set the TVe high alarm limit to be less than the current TVe. Verify that the [TVe Too High] alarm
is activated.

10.11.7 MVe Too Low


1. After the ventilator system is started normally, connect the ventilator to a test lung and start
ventilation.
2. Set the MV low alarm limit to be greater than the current MVe. Verify that the [MVe Too Low]
alarm is activated.

10.11.8 MVe Too High


1. After the ventilator system is started normally, connect the ventilator to a test lung and start
ventilation.
2. Set the MV high alarm limit to be less than the current MVe. Verify that the [MVe Too High] alarm
is activated.

10.11.9 ftotal Too Low


1. After the ventilator system is started normally, connect the ventilator to a test lung and start
ventilation.
2. Set the ftotal low alarm limit to be greater than the current ftotal. Verify that the [ftotal Too Low]
alarm is activated.

10.11.10 ftotal Too High

Operator’s Manual of Ventilator 10 - 7


Alarm Tests Alarms

1. After the ventilator system is started normally, connect the ventilator to a test lung and start
ventilation.
2. Set the ftotal high alarm limit to be less than the current ftotal. Verify that the [ftotal Too High]
alarm is activated.

10.11.11 Apnea
1. After the ventilator system is started normally, connect the ventilator to a test lung and start
ventilation.
2. Set the Tapnea alarm limit to 15s.
3. Set the f to be 3/min. Verify that the [Apnea] alarm is activated.

10.11.12 O2 Supply Failure


1. Connect the ventilator to high-pressure O2 supply, and set the O2 supply type to high-pressure
O2 supply in the ventilator.
2. Close the high-pressure O2 supply and verify whether the [O2 Supply Failure] alarm has been
activated.

10.11.13 FiO2 Too High


1. Connect the ventilator to low-pressure O2 supply, and set the O2 supply type to low-pressure O2
supply in the ventilator.
2. Connect a test lung to the ventilator and start ventilation.
3. After stable ventilation, set FiO2 high alarm limit to be less than the current O2% monitored
value.
4. Verify that the [FiO2 Too High] high priority alarm has been activated.

10.11.14 FiO2 Too Low


1. Connect the ventilator to high-pressure O2 supply, and set the O2 supply type to high-pressure
O2 supply in the ventilator.
2. Connect a test lung to the ventilator and start ventilation.
3. After stable ventilation, close the high-pressure O2 supply.
4. Verify that the [FiO2 Too Low] high priority alarm has been activated.

10.11.15 EtCO2 Too High


1. Connect a test lung to the ventilator and start ventilation.
2. Connect the CO2 watertrap and sampling line, and activate the CO2 monitoring function.
3. After CO2 warm-up is completed and the CO2 module enters operating mode, deliver 3% to 7%
of CO2 standard gas to the sampling port of sidestream CO2 module. Set the EtCO2 high alarm
limit to be less than the standard gas concentration.
4. Verify that the [EtCO2 Too High] high priority alarm has been activated.

10.11.16 EtCO2 Too Low


1. Connect a test lung to the ventilator and start ventilation.
2. Connect the CO2 watertrap and sampling line, and activate the CO2 monitoring function.

10 - 8 Operator’s Manual of Ventilator


Alarms Alarm Tests

3. After CO2 warm-up is completed and the CO2 module enters operating mode, deliver 3% to 7%
of CO2 standard gas to the sampling port of sidestream CO2 module. Set the EtCO2 low alarm
limit to be greater than the standard gas concentration.
4. Verify that the [EtCO2 Too Low] med priority alarm has been activated.

10.11.17 SpO2 Too High


1. Connect a test lung to the ventilator and start ventilation.
2. Connect the SpO2 sensor and activate the SpO2 monitoring function.
3. Connect the SpO2 sensor to the index finger, set the SpO2 Desat alarm limit as 0%, and set the
SpO2 low alarm limit as 0% and the SpO2 high alarm limit 2%.
4. Verify that the [SpO2 Too High] alarm has been activated.

10.11.18 SpO2 Too LOW


1. Connect a test lung to the ventilator and start ventilation.
2. Connect the SpO2 sensor and activate the SpO2 monitoring function.
3. Connect the SpO2 sensor to the index finger, set the SpO2 high alarm limit as 100%, and set the
SpO2 low alarm limit as 98%.
4. Grasp the wrist with another hand to press the pulse until the SpO2 reading is below 98%, and
verify that the [SpO2 Too LOW] alarm is activated.

10.11.19 SpO2 Desat


1. Connect a test lung to the ventilator and start ventilation.
2. Connect the SpO2 sensor and activate the SpO2 monitoring function.
3. Connect the SpO2 sensor to the index finger and set the SpO2 high alarm limit as 100%, the
SpO2 low alarm limit 98%, and the SpO2 Desat 98%.
4. Grasp the wrist with another hand to press the pulse until the SpO2 reading is below 98%, and
verify that the [SpO2 Desat] alarm is activated.

10.11.20 PR Too High


1. Connect a test lung to the ventilator and start ventilation.
2. Connect the SpO2 sensor and activate the SpO2 monitoring function.
3. Connect the SpO2 sensor to the index finger and set the PR higher alarm limit to 17 1/min.
4. Verify that the [PR Too High] alarm has been activated.

10.11.21 PR Too LOW


1. Connect a test lung to the ventilator and start ventilation.
2. Connect the SpO2 sensor and activate the SpO2 monitoring function.
3. Connect the SpO2 sensor to the index finger and set the PR higher alarm limit to 300 1/min and
the PR lower alarm limit to 298 1/min.
4. Verify that the [PR Too LOW] alarm has been activated.

Operator’s Manual of Ventilator 10 - 9


Nurse Call Alarms

10.12 Nurse Call


This ventilator supports nurse call function. When the nurse call function is enabled, the ventilator
outputs the signal to the nurse call system to call a nurse when a user-defined alarm is triggered.

The nurse call function is activated only when the following conditions are met:

1. The nurse call function is enabled;


2. An alarm meeting the user-defined conditions is triggered;
3. The ventilator is not in the AUDIO PAUSED state.
Follow the steps below to set the nurse call function:

1. Select [Menu] → [System] → enter the system password → [Interface] → [Nurse Call].
2. Set [Switch].
• : indicates to enable the nurse call function.
• : indicates to disable the nurse call function.
3. Set [Signal Type].
• [Pulse]: indicates that the output nurse call signals are the impulse signals lasting for one second.
When multiple alarms exist, only one impulse signal is output; if a new alarm is triggered before
the current alarm is resolved, another impulse signal will be output.
• [Continuous]: indicates that the duration of the output nurse call signal is the same as that of the
alarm, that is, from the occurrence of the alarm to the end of the alarm.
4. Set [Contact Type].
• [Normally Open]: Normally open signals are used to trigger the nurse call function.
• [Normally Closed]: Normally closed signals are used to trigger the nurse call function.
5. Set alarm level: to select the alarm level to trigger a nurse call signal.
6. Set alarm type: to select the alarm type to trigger a nurse call signal.
If no selection is made for alarm level or alarm type, no alarms will trigger a nurse call signal.

WARNING: Do not rely exclusively on the nurse call system for alarm notification.
Remember that the most reliable alarm notification combines audible
and visual alarm indications with the patient’s clinical condition.

WARNING: Use the specified nurse call cable when connecting with the hospital’s
nurse call system through the nurse call connection port. Failure to do
so may burn the machine and cause electric shock hazard.

WARNING: Inspect the ventilator alarm signals periodically when using the nurse
call function.

10.13 Responses to Alarms


Follow the steps below to take appropriate response measures when the ventilator triggers an alarm:

1. Check the patient’s condition.


2. Identify the alarming parameter or the alarm type.
3. Identify the cause of the alarm.
4. Eliminate the cause of the alarm.
5. Check whether the alarm has been cleared.
For specific response measures for various alarms, see (page D-1) D.0 “Alarm Messages”.

10 - 10 Operator’s Manual of Ventilator


Alarms Responses to Alarms

WARNING: Check whether the patient's ventilation is adequate when an alarm is


activated to prevent harm to the patient. Identify and eliminate the
cause of the alarm. Readjust the alarm limits only when they are
inappropriate for the current conditions.

CAUTION: Contact the Customer Service Department if the alarm persists without
obvious cause.

Operator’s Manual of Ventilator 10 - 11


Responses to Alarms Alarms

This page intentionally left blank.

10 - 12 Operator’s Manual of Ventilator


11.0 Cleaning and Disinfection

Cleaning and Disinfection Methods .......................................................................................................................................... 11-3

Operator’s Manual of Ventilator 11 - 1


Cleaning and Disinfection

WARNING: Please abide by applicable safety precautions.

WARNING: Read the material safety data sheet for each cleaning agent.

WARNING: Read the operation and service instructions for all disinfection
equipment.

WARNING: Wear safety gloves and glasses. A damaged O2 cell may cause leakage
or fire (containing potassium hydroxide).

WARNING: Reuse of reusable accessories or components before they are


disinfected may cause cross-infection.

WARNING: Prevent components from damage while disassembling and


reassembling them and ensure that the components are correctly
installed to prevent system leakage. Ensure that the cleaning and
disinfection methods are correct and applicable to the components.

WARNING: Disassemble and reassemble the components as per the instructions in


this chapter. Contact the Customer Service Department if further
disassembling operations are needed. Improper disassembling and
reassembling may lead to leakage and impact the proper operation of
the equipment.

WARNING: Ingress of liquid into the control assembly may damage the equipment
or cause personal injury. Ensure that no liquid enters the control
assembly and that the equipment is always disconnected from the AC
power supply during cleaning of casings.

WARNING: Reconnect the equipment to the power supply after the cleaned
components are fully dry.

WARNING: Do not use talc, zinc stearate, calcium carbonate, corn starch, or similar
materials to prevent sticky residuals. These materials may enter the
patient's lungs and airways and cause irritation or injury.

CAUTION: To prevent patient exposure to disinfection agents and to prevent


premature deterioration of parts, use the cleaning and disinfection
methods and agents recommended in this section.

CAUTION: To reduce the risk of electrical shock, disconnect electrical power from
the ventilator before cleaning and disinfection.

NOTE: Clean and disinfect the ventilator as needed before the first use of the
equipment. See this chapter for the cleaning and disinfection methods.

NOTE: If you have any questions regarding the cleaning agent, see the data
provided by the manufacturer to prevent damage to the equipment.

NOTE: Do not use organic, halogenated, or petroleum based solvents, glass


cleaners, acetone, or other harsh cleaning agents.

NOTE: Do not use abrasive cleaning agents (such as steel wool, silver polish, or
cleaner).

NOTE: Keep all liquids away from electronic components.

NOTE: Prevent liquid from penetrating into the equipment casing.

NOTE: The pH value of cleaning solutions must be within the 7.0~10.5 range.

11 - 2 Operator’s Manual of Ventilator


Cleaning and Disinfection Cleaning and Disinfection Methods

NOTE: After the cleaning and disinfection processes are completed, run a
system check before using the equipment. Use the equipment only
when the system check is passed.

NOTE: After the cleaning and disinfection processes are completed, check
whether the components have any damage or cracks. If so, replace the
component timely.

11.1 Cleaning and Disinfection Methods


Some of the ventilator's components can be cleaned and disinfected. Different components have
different requirements for cleaning and disinfection. It is recommended to select the appropriate
method to clean and disinfect various components based on actual situations in a timely and correct
manner to prevent cross-infection between ventilator users and patients.

The following table lists the recommended cleaning and disinfection methods for ventilator
components, including the methods for the first use and for repeated use.

Cleaning Disinfection
Recommended
Component C.
Interval ① ② A. Wipe B. Soak Ultraviolet
Wipe Soak
radiation
External surface
of ventilator
(including the
main unit
Each patient ① A or C
casing, the
power cord and
the gas supply
hose)
Trolley, support
Each patient ① A or C
arm, and IV pole
Touch screen Each patient ① A or C
Every four
Air inlet dust
weeks/as ② B
filter
necessarya
Each patient/ Refer to the cleaning and disinfection methods
SpO2 sensor
weekly provided in the attached instruction book.
SpO2 sensor Each patient/ Refer to the cleaning and disinfection methods
cable weekly provided in the attached instruction book.
Each patient/ Refer to the cleaning and disinfection methods
Nebulizer
weekly provided by the nebulizer manufacturer.

Operator’s Manual of Ventilator 11 - 3


Cleaning and Disinfection Methods Cleaning and Disinfection

Cleaning Disinfection
Recommended
Component C.
Interval ① ② A. Wipe B. Soak Ultraviolet
Wipe Soak
radiation
Each patient/ Refer to the cleaning and disinfection methods
Humidifier
weekly provided by the humidifier manufacturer.
How to clean:
① Wipe: Wipe with a damp cloth immersed in alkalescent detergent (soap water, etc.) or
alcohol solution, and then wipe off the remaining detergent with a dry lint-free cloth.
② Soak: Rinse with water first and then soak the components in an alkalescent cleaning agent
(soap water, etc.) (with the solution temperature recommended to be 40 ºC) for around three
minutes. Finally, rinse with clear water and dry completely.
How to disinfect:
A. Wipe: Wipe components with a damp cloth immersed in a moderately or highly efficient
disinfectant and then wipe off the remaining disinfectant with a dry lint-free cloth.
B. Soak: Soak components in a moderately or highly efficient disinfectant (for more than 30
minutes as recommended), and then rinse with clear water and dry completely.
C. Ultraviolet radiation for 30 to 60 minutes as recommended.
a. As necessary: shorten the cleaning and disinfection intervals if the equipment is used in dusty environment to
ensure that the equipment surface is not covered by dust.

TABLE 11-1 Cleaning and Disinfection Methods

The table below lists the cleaning agents and disinfectants applicable to the ventilator.

Name Category
Ethanol (75%) Moderately efficient disinfectant
Isopropanol (70%) Moderately efficient disinfectant
Glutaraldehyde (2%) Highly efficient disinfectant
Ortho-phthalaldehyde disinfectant (such as
Highly efficient disinfectant
Cidex®OPA)
Soap water (pH value of 7.0~10.5) Cleaning agent
Clean water Cleaning agent

TABLE 11-2 Cleaning Agents and Disinfectants

11 - 4 Operator’s Manual of Ventilator


Cleaning and Disinfection Disassemble the Ventilator’s Cleanable and Disinfectable Parts

11.2 Disassemble the Ventilator’s Cleanable and


Disinfectable Parts
11.2.1 HEPA Filter Components and Air Intake Dust Filter

FIGURE 11-1 HEPA Filter Components and Air Intake Dust Filter

A. HEPA filter
B. Air intake dust filter
C. Main unit air inlet baffle
To disassemble:

1. Pull the two snaps on the main unit air inlet baffle to remove the baffle.
2. Pull the snap on the HEPA filter to take it out. If it is necessary to remove the air intake dust filter,
pinch the dust filter with two fingers and take it out.
To install:

1. Align the HEPA filter with the corresponding slot, and push in the direction the HEPA filter is the
HEPA Filter installed. Fasten the snap of the HEPA filter.
2. Check the snap on the HEPA filter and make sure it is fastened in place.
3. Install the air intake dust filter.
4. Install the main unit air inlet baffle.

CAUTION: Install the specified HEPA filter and air intake dust filter.

CAUTION: Do not operate the ventilator if the ventilator is not equipped with a
HEPA filter. Otherwise, the inspiration end of the device and patient
tubing will be contaminated.

Operator’s Manual of Ventilator 11 - 5


Disassemble the Ventilator’s Cleanable and Disinfectable Parts Cleaning and Disinfection

11.2.2 Patient Tubing


WARNING: To minimize the risk of bacterial contamination or physical damage,
remove and install the bacterial filter with care.

WARNING: To prevent patient or ventilator contamination, always use a bacteria


filter between the ventilator and the patient inspiratory limb.

CAUTION: The patient tubing shall comply with the requirements of ISO 5367.

CAUTION: The bacteria filters shall comply with the requirements of ISO 23328-1
and ISO 23328-2.

CAUTION: The Heat & Moisture Exchange (HME) shall comply with the
requirements of ISO 9360-1 and ISO 9360-2.

CAUTION: When removing the reusable patient tubing, disconnect the tubes from
the ventilator connectors instead of pulling the tubes.

F
A G

B H

FIGURE 11-2 Patient Tubing

11 - 6 Operator’s Manual of Ventilator


Cleaning and Disinfection Disassemble the Ventilator’s Cleanable and Disinfectable Parts

A. Mask
B. Exhalation port
C. Patient tubing
D. Proximal pressure monitoring sampling line
E. Watertrap
F. Bacteria filter
G. Proximal pressure monitoring port
H. Bacteria filter
To disassemble:

Pull out the patient tubing one by one.

To install:

1. Install the bacteria filter onto the inspiratory port of the ventilator.
2. Connect the bacteria filter to the humidifier inlet via the tubing.
3. Connect the humidifier outlet to the watertrap via the tubing.
4. If the oro-nasal mask (non-vented) or the ET/Trach tube is used, the exhalation port is needed.
Connect the watertrap to the exhalation port via the tubing, and then connect the exhalation
port and mask.
5. If the ET/Trach tube is used, the exhalation port is needed. Connect the watertrap to the
exhalation port via the tubing, and then connect the exhalation port and ET/Trach tube.
6. If the oro-nasal mask (vented) or total face/nasal mask is used:
• If the exhalation port is not used, connect the watertrap with the face/nasal mask via the
tubing.
• If the exhalation port is used, connect the watertrap to the exhalation port via the tubing,
then connect the exhalation port to the face/nasal mask.
7. Connect the proximal pressure monitoring sampling line to the proximal pressure monitoring
port.
8. Install the bacteria filter.
9. If the exhalation port is used, connect the proximal pressure monitoring sampling line to it.
10. If the exhalation port is not used, connect the proximal pressure monitoring sampling line to the
face/nasal mask.
11. Place the patient tubing onto the support arm hook.

11.2.3 Humidifier
WARNING: To prevent possible patient injury and equipment damage, ensure the
humidifier is set to appropriate temperature and humidity.

WARNING: To prevent possible patient injury and equipment damage, ensure the
humidifier is set to appropriate temperature and humidity.

NOTE: The humidifier shall comply with the requirements of ISO 8185ISO
80601-2-74. Refer to the humidifier accompanying directions for use to
install and use the humidifier. The humidifier assembly and its
installation steps described in this section are only for reference.

Operator’s Manual of Ventilator 11 - 7


Disassemble the Ventilator’s Cleanable and Disinfectable Parts Cleaning and Disinfection

C
A
D

FIGURE 11-3 Humidifier

A. Humidifier mounting plate


B. Humidifier
C. Screw
D. Fixing seat of humidifier bracket
To disassemble:

1. Disconnect the tubes from the humidifier.


2. Remove the screw.
3. Lift up the humidifier to remove it from the fixing seat of humidifier bracket.
To install:

1. Align the humidifier mounting plate to the fixing seat of humidifier bracket, and slide the
humidifier in.
2. Tighten the screws.

11 - 8 Operator’s Manual of Ventilator


12.0 Maintenance

Maintenance Principle........................................................................................................................................................................ 12-2


Maintenance Schedule ...................................................................................................................................................................... 12-2
Exhalation port Calibration.............................................................................................................................................................. 12-4
Pressure Zeroing .................................................................................................................................................................................... 12-4
Oxygen Concentration Calibration............................................................................................................................................. 12-4
CO2 Maintenance.................................................................................................................................................................................. 12-5
Battery Maintenance............................................................................................................................................................................ 12-6
Electrical Safety Inspection .............................................................................................................................................................. 12-8

Operator’s Manual of Ventilator 12 - 1


Maintenance Principle Maintenance

12.1 Maintenance Principle


WARNING: Please abide by disinfection control and safety procedures as used
equipment may be contaminated by blood or body fluids.

WARNING: Movable parts and removable components may cause a pinch or a


crush. Exercise caution when moving or replacing system parts and
components.

WARNING: Do not use the lubricants that contain oil or grease which may burn or
explode when exposed to a high O2 concentration.

Do not use malfunctioning equipment. Try to seek help from a service representative authorized by
the manufacturer for all necessary servicing operations. Or you can seek help from a qualified
professional for the replacement and servicing of the parts listed in this manual.

After servicing, test the equipment to ensure that it functions properly in accordance with the
specifications.

NOTE: Personnel with no servicing experience for such a type of equipment


shall not engage in servicing of the equipment.

NOTE: The parts manufactured or sold by the manufacturer shall be used to


replace the damaged parts. The equipment shall be tested after any
part is replaced to ensure that it complies with the manufacturer's
specifications and requirements.

NOTE: Please abide by the local applicable laws and regulations or the
hospital's waste disposal systems for disposing of accessories and
replaced parts and never discard them at random.

NOTE: Contact the Customer Service Department if you need any service or
support.

NOTE: For further information about the product, contact the Customer
Service Department. Documents for some components can be provided
depending on the actual situation.

12.2 Maintenance Schedule


COMPONENT/
INTERVAL ACCESSORY MAINTENANCE

Patient tubing
Each patient (including mask,
Use disinfected components or new disposable
or as inspiratory filter
components.
necessary and exhalation
port)
Calibrate the CO2 module when the measured CO2
CO2 calibration value has a great deviation. Refer to (page 12-5) 12.6
“CO2 Maintenance”.
As necessary Replace the exhalation port if it is damaged. Refer to
(page 11-6) 11.2.2 “Patient Tubing” for detailed
Exhalation port
installation and disassembly methods of the exhalation
port.

12 - 2 Operator’s Manual of Ventilator


Maintenance Maintenance Schedule

COMPONENT/
INTERVAL ACCESSORY MAINTENANCE

Check the water gathered in the patient tubing and


empty water build-up in a timely manner.
Several times
Inspect the parts for damage. Replace as necessary.
a day or as Patient tubing
Refer to (page 11-6) 11.2.2 “Patient Tubing” for detailed
necessary
installation and disassembly methods of the patient
tubing.
When the
component
is being Ventilator Inspect the parts for damage. Replace as necessary.
cleaned or
installed
Ventilator Clean the external surfaces.
Please calibrate the O2 cell. Refer to (page 12-4) 12.5
Daily or as “Oxygen Concentration Calibration”. Replace the O2 cell
necessary O2 cell if it is damaged. Refer to (page 3-12) 3.10 “Install O2
Sensor” for detailed installation and disassembly
methods of the O2 cell.
Check the dust filter for dust build-up. Clean or replace
as necessary. Refer to (page 11-5) 11.2.1 “HEPA Filter
Monthly or Air intake dust
Components and Air Intake Dust Filter” for detailed
as necessary filter
installation and disassembly methods of the air intake
dust filter.
Check the charging and discharging of the lithium
Check every
battery every six months and replace the lithium
six months
battery every three years. Contact the Customer Service
and replace Lithium battery
Department for replacement. Check the buzzer alarm
every three
duration and verify that the alarm lasts for at least 120
years
seconds when replacing the lithium battery.
Contact the Customer Service Department for
Ventilator
preventive maintenance.
Replace the O2 cell if it is damaged. Refer to (page 3-12)
3.10 “Install O2 Sensor” for detailed installation and
disassembly methods of the O2 cell.
[Note] If the ICU functions properly, the service life of
Annually, or
O2 cell the O2 cell is about one year. The service life of O2 cell is
every 5000
an approximate specification only. The actual service
hours, or as
life depends on the operating environment. Operation
necessary
at higher temperatures or higher oxygen
concentrations shortens the sensor’s life.
Replace it. Refer to (page 11-5) 11.2.1 “HEPA Filter
Air intake HEPA Components and Air Intake Dust Filter” for detailed
filter installation and disassembly methods of the air intake
HEPA filter.
Every 6 years
Battery of the Replace the battery of the clock module. Contact the
or as
clock module Customer Service Department for replacement.
necessary

TABLE 12-1 Maintenance Schedule

Operator’s Manual of Ventilator 12 - 3


Exhalation port Calibration Maintenance

12.3 Exhalation port Calibration


1. Select the icon or , and set [Whether exhalation port is connected] to [Yes] in the
opened interface.
2. Select the [Calibration] button on the right side. When the exhalation port calibration is started,
the prompt message [Keep circuit outlet occluded until calibration is completed.] will be
displayed.
3. During calibration, press [Cancel] to stop the ongoing process. At the same time, the system will
display a prompt message [Calibration Stopped! Calibration is unfinished.].
4. After a successful calibration, the screen shows [Calibration Completed!]. Otherwise, the
message indicating calibration failure is displayed. In this case, you need to do the calibration
again.

12.4 Pressure Zeroing


Zero the pressure when the monitored pressure value has a great deviation. Zeroing can be
performed in both Standby mode and ventilation mode.

1. Select [Menu] → [Calibration] → [Zero] and select the [Start] key on the right side. After
pressure zero is started, the system will display a prompt message: [Zero calibration runnning].
2. If the zero is successful, the system will display a prompt message: [Zero calibration succeed.].
Otherwise, the system will prompt a zero failure. In this case, zero the system again.

12.5 Oxygen Concentration Calibration


NOTE: Do not perform oxygen concentration calibration while the system is
connected to a patient.

NOTE: Ensure that the system is in Standby mode. If not, press the [Standby]
key to enter standby screen.

NOTE: The O2% measurement accuracy drift shall meet the requirements of
ISO 80601-2-55.

Calibrate the oxygen concentration when the measured oxygen concentration has a great deviation
from the setting, or when the O2 sensor is replaced. Follow these steps to calibrate the oxygen
concentration:

1. Ensure that the oxygen gas supply is connected.


2. Select [Menu] → [Calibration] → [O2 Calibration] and select the [Start] key on the right side.
When the oxygen concentration calibration is started, the system will display a prompt message
[Calibrating].
3. During calibration, press [Stop] to stop the ongoing process. At the same time, the system will
display a prompt message [Calibration Stopped! Calibration is unfinished.].
4. After a successful calibration, the screen shows [Calibration succeed.]. Otherwise, the message
indicating calibration failure is displayed. In this case, do the calibration again.

NOTE: In case of calibration failure, check for relevant malfunctioning alarm


and then troubleshoot it. Then do the calibration again. In case of
repeated calibration failures, replace the O2 cell and perform the
calibration again. If it still fails, contact the service personnel or the
manufacturer for support.

NOTE: Handle and dispose of the O2 cell in accordance with related biohazard
policies. Do not incinerate.

12 - 4 Operator’s Manual of Ventilator


Maintenance CO2 Maintenance

NOTE: Oxygen concentration monitoring does not provide automatic


atmospheric pressure compensation. Do oxygen concentration
calibration again when atmospheric pressure has changed.

NOTE: Increasing to periodical pressure of 10 kPa (100 cmH2O) has no effect


upon oxygen concentration monitoring accuracy.

NOTE: O2 cell measures the partial pressure of oxygen. Increase or decrease of


pressure (absolute pressure) affects the partial pressure of oxygen.
Increase of pressure (absolute pressure) by 10% causes oxygen
concentration to increase by 10%. Decrease of pressure (absolute
pressure) by 10% causes oxygen concentration to decrease by 10%. Do
oxygen concentration calibration when atmospheric pressure has
changed.

12.6 CO2 Maintenance


12.6.1 CO2 Zeroing
You can select [Menu] → [Calibration] → [CO2 Maintenance], and then select [Zero] button in
standby mode. It is unnecessary to disconnect the senor from the breathing system when
performing the zeroing.

12.6.2 CO2 Calibration


NOTE: Ensure that the system is in Standby mode. If not, press the [Standby]
key to enter standby screen.

Prepare the following before performing the calibration:

• Gas cylinder: cylinders filled with 3% to 7% CO2


• T-shape connector
• Sampling line
The calibration procedure is as follows:

1. Check the airway and ensure that there is no occlusion or leakage. Ensure that the CO2 module
is already warmed up or started.
2. Select [Menu] → [Calibration] → [CO2 Maintenance], and select the [Zero] key.
3. After zeroing, connect the gas cylinder with the sampling line via a T-shape connector as shown
below. Check the airway and ensure that there is no leakage.

Open to the air

Sampling line

Pressure
relief valve
CO2 module

Gas
cylinder

FIGURE 12-1 CO2 Module Calibration

Operator’s Manual of Ventilator 12 - 5


Battery Maintenance Maintenance

4. Expose the sampling line to standard CO2 by opening the cylinder pressure relief valve.
5. Select the [Continue] key, input the applied CO2 concentration in the entry box of the interface.
6. The measured CO2 concentration is displayed. After the measured CO2 concentration becomes
stable, select [Calibration] to calibrate the CO2 module. The message [Calibrating] will be
displayed.
7. After a successful calibration, the screen displays [Calibration succeed.]. Otherwise, the system
will prompt a message [Calibration Failure! Please try again.]. In this case, calibrate the system
again.

12.7 Battery Maintenance


WARNING: The service life of lithium battery is three years. Please replace the
lithium battery after its service life expires.

CAUTION: The batteries can only be charged by this ventilator.

NOTE: Use the batteries at least once a month to extend their service lives.
Charge the batteries before the battery power runs up.

NOTE: Please check and replace the batteries regularly. The service lives of the
batteries depend on how frequently they are used and how long they
have been in service. For a properly maintained and stored lithium
battery, the service life is approximately three years. Improper use of
the battery may shorten its service life.

NOTE: In the case of a battery fault, contact the manufacturer or have


designated service personnel replace it. Do not replace the battery on
your own.

The ventilator has built-in rechargeable batteries to ensure proper functioning of the ventilator even
in the case of power failures. When the ventilator is connected to an external power supply, the
batteries are charged regardless of whether the ventilator is on or off. In the event of a sudden power
failure, the system will automatically switch to battery power supply without interrupting the
operation of the ventilator. When the external power supply resumes within a specified period of
time, the system will terminate battery power supply and automatically switch to external power
supply to ensure continuous operation of the ventilator.

The battery icon in the power icon field on the screen indicates the battery status:

• : An external power supply is connected. The ventilator is powered by an external


power supply. The solid part of the battery icon represents the remaining battery level.
• : No external power supply is connected. The ventilator is powered by the built-in
batteries. The solid part of the battery icon represents the remaining battery level.
• : No external power supply is connected. The ventilator is powered by the built-in
batteries. Battery level is low and the batteries need to be charged immediately.
• : No batteries are installed in the ventilator.
The batteries can support the ventilator for a limited period of time. When the battery level is too low,
the ventilator will trigger a technical alarm of [Low Battery. Connect Ext. Power.]. In this case, you
need to connect the ventilator to an external power supply.

12.7.1 Guidelines for Battery Use


Please check and replace the batteries regularly. The service lives of the batteries depend on how
frequently they are used and how long they have been in service. For a properly maintained and
stored lithium battery, the service life is approximately three years. Improper use of the battery may
shorten its service life. It is recommended to replace the lithium batteries once every three years.

12 - 6 Operator’s Manual of Ventilator


Maintenance Battery Maintenance

Please note the following instructions to ensure the maximum battery capacity:

• Check the battery performance once every six months. Check the battery performance
before the ventilator receives a service or when a battery-caused fault is suspected.
• Optimize the batteries after every three months of use or when the battery life is significantly
reduced.

12.7.2 Optimize Battery Performance


Optimize the batteries before the first use of them. A complete battery optimization cycle includes:
uninterrupted charging, uninterrupted discharging until the ventilator is powered off, and then
uninterrupted charging. During battery usage, optimize the battery performance regularly to
maintain their service lives.

NOTE: Optimize the batteries after every three months of use or when the
battery life is significantly reduced.

NOTE: The actual battery capacity will reduce after the batteries have been
used for some time. For an old battery, the battery full icon does not
indicate the compliance of the battery capacity or the battery life with
the manufacturer specifications. Please replace the batteries if the
battery life is significantly reduced during optimization.

Please follow the steps below during optimization:

1. Disconnect the ventilator from the patient and power off the ventilator.
2. Connect the ventilator to an external power supply to charge the batteries uninterruptedly for
at least 10 hours.
3. Disconnect the external power supply to power the ventilator with the batteries until the
ventilator is powered off.
4. Reconnect the ventilator to the external power supply to charge the batteries uninterruptedly
for at least 10 hours.
5. The battery optimization is now completed.

12.7.3 Check Battery Performance


Check the battery performance once every six months. Check the battery performance before the
ventilator receives a service or when a battery-caused fault is suspected. The battery performance
may decrease over time.

Please refer to the steps below to check battery performance:

1. Disconnect the ventilator from the patient and power off the ventilator.
2. Connect the ventilator to an external power supply to charge the batteries uninterruptedly for
at least 10 hours.
3. Disconnect the external power supply to power the ventilator with the batteries until the
ventilator is powered off.
4. The battery life length reflects the battery performance.
If the battery life is significantly shorter than that specified in the specifications, please replace the
batteries or contact the service personnel.

NOTE: If the battery life is too short after being fully charged, the batteries
may already be damaged or faulty.

NOTE: If obvious damage is observed on the batteries, or the batteries fail to


hold the charge, replace the batteries and dispose of the old batteries
following correct recycling procedures.

Operator’s Manual of Ventilator 12 - 7


Electrical Safety Inspection Maintenance

12.7.4 Store Batteries


Ensure that the battery electrodes are not in touch with metal during storage. In the case of long-
time storage, place the batteries in a cool environment and keep the battery level at 40% to 60%.

Storing the batteries in a cool environment can delay battery ageing. Ideally, the batteries should be
stored in a cool environment of 15°C (60°F). Do not store the batteries in an environment out of the
range specified in (page B-2) B.2 “Environment Specifications”.

Remove the batteries from the ventilator if the ventilator is not to be used for a long time. Otherwise
the batteries may be over-discharged, which can significantly extend the batteries’ charging time.
Partially charge any stored batteries once every two months to keep their battery levels at 40% to
60%. Fully charge the batteries before use.

NOTE: Remove the batteries from the equipment if the equipment is not to be
used for a long time.

NOTE: Storing the batteries in an environment of above 35°C (95°F) for a long
time may greatly shorten the expected service lives of the batteries.

12.7.5 Recycle Batteries


If obvious damage is observed on the batteries, or the batteries fail to hold the charge, replace the
batteries and dispose of the old batteries following correct recycling procedures. Dispose of used
batteries in compliance with applicable laws and regulations.

WARNING: Do not disassemble batteries, throw them into fire, or short-circuit


them. Battery burning, explosion or leakage may cause personal injury.

12.8 Electrical Safety Inspection


NOTE: Perform an electrical safety inspection after servicing or routine
maintenance. Before performing the electrical safety inspection,
ensure that all the covers, panels, and screws are correctly installed.

NOTE: It is recommended that a specialized company or the manufacturer be


entrusted to conduct electrical safety tests. The electrical safety
inspection should be performed once a year.

1. Perform protective earth resistance test:


a. Plug the probes of the analyzer into the protective earth terminal of the AC power cord and
the screw.
b. Test the earth resistance with a current of 25A.
c. Verify that the impedance value is not greater than 0.1 ohms (100 mohms).
d. If the impedance value is greater than 0.1 ohms (100 mohms) but smaller than 0.2 ohms
(200 mohms), remove the AC power cable, and connect the probe that was originally
connected to the protective grounding terminal of the AC power supply to the protective
grounding terminal of the power outlet. Then repeat Steps a to c.
2. Perform the following earth leakage current tests:

12 - 8 Operator’s Manual of Ventilator


Maintenance Electrical Safety Inspection

• Normal polarity
• Reverse polarity
• Normal polarity with open neutral
• Reverse polarity with open neutral
Verify that the maximum leakage current does not exceed 500 μA (0.5 mA) in the first two
tests. While for the last two tests, verify that the maximum leakage current does not exceed
1000 μA (1 mA).
3. Perform the following patient leakage current tests:
• Normal polarity
• Reverse polarity
• Normal polarity with open neutral
• Reverse polarity with open neutral
• Normal polarity with open earth
• Reverse polarity with open earth
• Normal polarity with mains on AP
• Reverse polarity with mains on AP
4. Verify the maximum leakage current of the BF-type applied part does not exceed 100 μA (0.1
mA) in the first two tests. For the mid four tests, verify that the maximum leakage current does
not exceed 500 μA (0.5 mA). While for the last two tests, verify that the maximum leakage
current does not exceed 5000 μA (5 mA).

NOTE: Ensure the safety analyzer is authorized by certificate organizations


(UL, CSA, AAMI, etc.). Follow the instructions of the analyzer
manufacturer.

Operator’s Manual of Ventilator 12 - 9


Electrical Safety Inspection Maintenance

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12 - 10 Operator’s Manual of Ventilator


13.0 Accessories

Accessories List........................................................................................................................................................................................ 13-2

Operator’s Manual of Ventilator 13 - 1


Accessories List Accessories

WARNING: Please use the accessories specified in this chapter only. Using other
accessories may lead to inaccurate measured values or equipment
faults.

WARNING: Disposable accessories shall be used only once. Repeated use may lead
to performance degradation or cross-infection.

WARNING: All the accessories in contact with human bodies meet the
biocompatibility requirements in the ISO 10993-1 standard and are
expected to cause no adverse reactions when in contact with human
bodies.

WARNING: Please do not use an accessory that shows signs of damage in its
package or itself.

WARNING: Please abide by the local applicable laws and regulations or the
hospital’s waste disposal systems for disposing of accessories and
never discard them at random.

WARNING: When the device and its accessories reach their service life, they must
be disposed of in accordance with the guidelines for managing the
disposal of such products and local regulations for contaminated and
biologically hazardous items.

WARNING: Please purchase legally launched products for other accessories


required to implement the functions of the machine.

NOTE: The accessories listed in the following table are applicable to the
ventilator. The hospital is responsible for ensuring that the ventilator is
compatible with accessories. Incompatibility between the ventilator
and accessories can degrade the ventilator performance.

13.1 Accessories List

DESCRIPTION OF COMPONENT PART NUMBER


NIV Oronasal mask/Vented (S) 040-006456-00
NIV Oronasal mask/Vented (M) 040-006457-00
NIV Oronasal mask/Vented (L) 040-006458-00
Mask for O2 therapy (Ped) 040-002366-00
Mask for O2 therapy (Adult) 040-002365-00
Disposable NIV non-heated breathing circuit, Adult 040-006315-00
Disposable NIV heated breathing circuit/F&P, Adult 040-006317-00
Disposable NIV heated breathing circuit, Adult 040-006316-00
Reusable NIV heated breathing circuit, Adult 040-006322-00
Disposable exhalation port 040-006299-00
Disposable whisper swivel 040-006298-00
Nasal Cannula for O2 therapy (medium) 040-002377-00
Nasal Cannula for O2 therapy (large) 040-002378-00
Nasal Cannula for O2 therapy (small) 040-002376-00
Nasal Cannula for O2 therapy (large)*10 115-037831-00
Nasal Cannula for O2 therapy (small)*10 115-037829-00

13 - 2 Operator’s Manual of Ventilator


Accessories Accessories List

Nasal Cannula for O2 therapy (medium) 10pcs 115-037830-00


Sidestream CO2 nasal sampling tube/Adult M02A-10-25937
Sidestream CO2 nasal sampling tube/Ped M02A-10-25938
Heat Moisture Exchanger (with filter) 040-001571-00
Electrical nebulizer 040-003539-00
O2 sensor 040-001275-00
Demo lung (Test lung), Adult 040-000744-00
Sidestream CO2 kit/Adu 115-081994-00
Sidestream CO2 kit/Ped 115-081995-00
*SpO2 accessory kit/Adu/Reuse 0651-30-77014
*SpO2 accessory kit/Ped/Reuse 0651-30-77015
Feeding tube with single balloon/single use (5pcs) 115-078606-00
AC power cord (EU, 3.5m) TSB1-20-20509
Power cord (UK) DA8K-10-14453
LPO transform interface (for 3/16 '' ID gas hole) 082-001920-00
O2 Supply Reductor 14Mpa 082-001927-00
Support arm and IV pole (not fixing aids) 034-000710-00
Fixing aids 034-000861-00
Support arm 034-000652-00
IV pole 034-000653-00
Trolley for SV70 series 045-004835-00
Temperature probe for Jike SH530, 1.5m 040-001548-00
Heating wire adapter for Jike SH530 040-001554-00
Disposable water chamber (Adult/Pediatric) - JK530 040-002173-00
Reusable water chamber (Adult/Pediatric) -JK530 040-001530-00
Jike SH330/EU 115-018049-00
Jike SH530/EU/Adult/Disposable 115-081878-00
Jike SH330/UK 115-018053-00
Jike SH530/UK/Adult/Disposable 115-081881-00
Disposable NIV heated breathing circuit kit/Jike, Adult 115-079705-00
Reusable NIV heated breathing circuit kit/Jike, Adult 115-081877-00
Pendant mount for humidifier 115-006158-00
Gas Hole for cylinders, O2 Supply, Eur,34I-OXY-DS/NS-0.6 082-001926-00
O2 hose 3m, Ger, NIST-2 115-008257-00
O2 hose 3m, Fra, NIST-2 115-008259-00
O2 hose 3m, UK, NIST-2 115-008201-00
Disposable bacteria filter 040-001831-00
One more battery for SV70 series (accessory sale) 115-079845-00
HEPA filter 045-001333-01

TABLE 13-1 Accessories List

Operator’s Manual of Ventilator 13 - 3


Accessories List Accessories

*:

The pulse oximeter probes and probe cable extenders listed for this device have been validated and
tested for compliance with ISO 80601-2-61.

The SpO2 sensor material that contacts patients or other staff has undertaken the bio-compatibility
test and is verified to be in compliance with ISO 10993-1.

Wavelength emitted by the sensors intended for Mindray SpO 2 module: red light: 660 nm, infrared
light: 905 nm.

The maximum photic output consumption of the sensor is less than 18 mW.

The information about the wavelength range and maximum photic output consumption can be
especially useful to clinicians, for example, clinicians performing photodynamic therapy.

13 - 4 Operator’s Manual of Ventilator


A.0 Theory of Operation

Pneumatic Circuit Principle ............................................................................................................................................................... A-2


Electrical System....................................................................................................................................................................................... A-3

Operator’s Manual of Ventilator A-1


Pneumatic Circuit Principle Theory of Operation

ᐕ֌৏⨶
A.1 Pneumatic
≄䐟৏⨶ Circuit Principle
A.1.1 Pneumatic
≄䐟৏⨶മ Circuit Diagram

3

3 26

Ambient Blower Q2 EP Patient


air
F1 F2
3
Low- Q1
pressure
oxygen
3
High-
pressure PSOL1
oxygen

FIGURE A-1 Pneumatic Circuit Diagram

A.1.2 Parts List

SYMBOL NAME
Ambient air Ambient air
Low-pressure oxygen Low-pressure oxygen supply
High-pressure oxygen High-pressure oxygen supply
F1 Air inlet filter
F2 Air filter
P1 Air inlet pressure sensor
P2 Oxygen inlet pressure sensor
PSOL1 Proportional solenoid valve
Q1 O2 flow sensor
Blower Turbine blower
OS O2 sensor
Q2 Main flow sensor
P3 Ventilator-side pressure sensor
P4 Patient-side pressure sensor
EP Patient tubing and accessories
Patient Patient

TABLE A-1 Parts List

A-2 Operator’s Manual of Ventilator


Theory of Operation Electrical System

A.1.3 Principle Description


The gas supply of ventilator can be divided into air supply and oxygen supply. The air supply is
provided by the surrounding environment. The ventilator filters the air passing through the air inlet
filter to remove impurities, bacteria, and viruses. The oxygen supply can be divided into high-pressure
oxygen supply and low-pressure oxygen supply. When oxygen enters the ventilator from the high-
pressure oxygen gas supply, the flow of oxygen is adjusted through the proportional solenoid valve.
The high-pressure oxygen gas supply and low-pressure oxygen gas supply regulated by the
proportional solenoid valve are monitored by the oxygen flow sensor.

The turbine blower sucks in oxygen and air for mixed pressurization. The pressurized mixed gas is
monitored by the main flow sensor, and the pressure and oxygen concentration of the mixed gas are
monitored by bypass at the front of the flow sensor. The mixed gas is transported to the inspiratory
port of the ventilator through the main flow sensor.

The gas output by the ventilator is delivered to the patient through main filters and patient tubing. A
pressure sensor is connected to the patient tubing near the patient's end to monitor the inspiratory
pressure of the patient during the breathing process. CO2 and other gases produced by the patient's
respiration are exhausted through the expiratory port on the pipeline to reduce the repeated
inhalation of CO2 and ensure the effective removal of CO2.

A.2 Electrical System


A.2.1 Electrical System Structure Diagram

B5
S15
B6
S0 S1 B2

S2 S3
B1
B4 S4
S2

S5
B8
S6
S7
S14
S7 B3
B7
S8
B9
S9

S10
B10

S12
B11 S11
S13

S15 B12

FIGURE A-2 Electrical System Structure Diagram

Operator’s Manual of Ventilator A-3


Electrical System Theory of Operation

A.2.2 Parts List


Sym Name Symb Name
bol ol
S0 Total AC input and fuse S14 Coder
S1 AC-DC power module S15 Fan
S2 Battery B1 Battery adapter board
S3 Touch screen B2 DC-DC power board
S4 Display B3 Monitoring board
S5 Speaker B4 Main board
S6 Wi-Fi module B5 Alarm indicator board
S7 Zeroing three-way valve B6 Power switch indicator board
S8 O2 flow sensor B7 Sensor adapter board
S9 Total branch flow sensor B8 Gas supply pressure sensor board
S10 O2 sensor B9 Energy capacitor board
S11 SpO2 probe B10 Vacuum sensor board
S12 Oxygen proportional valve B11 SpO2 module
S13 Blower B12 CO2 module

TABLE A-2 Parts List

A-4 Operator’s Manual of Ventilator


B.0 Product Specifications

Safety Specifications ...............................................................................................................................................................................B-2


Environment Specifications ...............................................................................................................................................................B-2
Power Supply Specifications .............................................................................................................................................................B-3
Physical Specifications...........................................................................................................................................................................B-3
Pneumatic System Specifications...................................................................................................................................................B-5
Ventilator Specifications.......................................................................................................................................................................B-6
Ventilator Accuracy..................................................................................................................................................................................B-7
Alarms ..............................................................................................................................................................................................................B-9
Special Function........................................................................................................................................................................................B-9
CO2 Module..............................................................................................................................................................................................B-10
CO2 Alarm Limit .....................................................................................................................................................................................B-10
SpO2 Alarm Limit...................................................................................................................................................................................B-11

Operator’s Manual of Ventilator B-1


Safety Specifications Product Specifications

The ventilator has integrated the expiratory volume monitor and pressure measurement device. It
has built-in alarm system, SpO2 monitor, O2 monitor and CO2 monitor. Where:

• The expiratory volume monitor, pressure measurement device and pressure release device
comply with the ISO 80601-2-12;
• The alarm system complies with the IEC 60601-1-8;
• The SpO2 monitor complies with the ISO 80601-2-61;
• The O2 monitor complies with the ISO 80601-2-55;
• The CO2 monitor complies with the ISO 80601-2-55;
• The gas supply hose assembly should comply with the ISO 5359 & ISO 18082 standard.

B.1 Safety Specifications


Classified by the type of protection Class I equipment with an internal electrical power
against electric shock supply
Classified by the degree of
BF, Defibrillation-proof
protection against electric shock
IP21
Protection Index according the EN 60529 standard:
Classified by degree of protection 2: Protected against solid foreign objects of 12.5 mm
against harmful ingress of water diameter and greater
1: Protected against vertically falling water drops
0: no protection
Classified by the sterilization and
Equipment with the manufacturer-recommended
disinfection methods recommended
sterilization and disinfection methods applied
by manufacturer
Classified by the safety level when
flammable anesthetic gas mixed
Not applicable to an environment containing flammable
with air or flammable anesthetic gas
anesthetic gas
mixed with oxygen or nitrous oxide is
used
Classified by the operational mode Continuous running equipment
Whether the equipment has applied
All applied parts support protection against the
parts that support protection against
defibrillation discharge effect
the defibrillation discharge effect
Whether the equipment has signal
With signal input and output parts
output or input parts

TABLE B-1 Safety Specifications

B.2 Environment Specifications


MAIN UNIT
Relative humidity
Item Temperature (ºC) Barometric pressure (kPa)
(non-condensible)
Operation 5 to 40 10% to 95% R.H. 62 to 106
Transportation and -20 to 60
10% to 95% R.H. 50 to 106
storage (O2 cell: -20 to 50)

TABLE B-2 Environment Specifications

B-2 Operator’s Manual of Ventilator


Product Specifications Power Supply Specifications

B.3 Power Supply Specifications


EXTERNAL AC POWER SUPPLY
Input voltage 100 to 240 V~
Input frequency 50/60 Hz
Input current 2.7 to 1.1A

INTERNAL BATTERIES
Number of batteries 1 or 2
Battery type Lithium-ion battery
Battery capacity 6,600 mAh per battery
10 min at least (powered by new fully charged batteries after the first
Time to shutdown
low battery alarm)
180 minutes (powered by one piece aged fully-charged battery
according to ISO 80601-2-12)
360 minutes (powered by two pieces aged fully-charged batteries
Battery running time according to ISO 80601-2-12)

NOTE: Ventilator’s working condition complies


with ISO 80601-2-12.

TABLE B-3 Power Supply Specifications

B.4 Physical Specifications


SYSTEM NOISE

System noise A-weighted sound pressure level (LpA) ≤ 45 dB(A)


A-weighted sound power level (L WA ) ≤ 53 dB (A)
OVERALL DIMENSIONS

Operator’s Manual of Ventilator B-3


Physical Specifications Product Specifications

365±10mm

260±10mm
200±10mm

390±10mm

1380±10mm
Dimensions

1016±10mm
213±10mm

m
m
± 10
530

545±10mm

Main unit weight: ≤ 12 kg


Overall weight: ≤ 40 kg
Note:
The main unit weight includes screen, but excludes the module,
Weight
trolley, tube accessories, support arm and humidifier.
The overall weight includes the main unit (with one battery) and the
trolley, but excludes the module, tube accessories, support arm and
humidifier.
CASTER
Caster Four casters. All casters have brakes.

DISPLAY
Type TFT LCD
Size 15.6"
Resolution 1920*1080
Brightness Adjustable

LED INDICATOR
Alarm LED One (red for high alarms, yellow for medium and low alarms)
Power LED One (green. Lit when an external power supply is connected.)
One (green. Lit when a battery is installed and an external power
Battery LED supply is connected; flashing when powered by batteries;
extinguished when no battery is installed)
AUDIO INDICATOR
Gives off alarm tones and key tones; supports multi-level tone
Speaker modulation. The alarm tones comply with the requirements of
IEC60601-1-8.
Buzzer Gives off auxiliary audio alarm in case of speaker malfunction.

CONNECTOR

B-4 Operator’s Manual of Ventilator


Product Specifications Pneumatic System Specifications

Connects to the external calibration device. An external medical


RS232 connector device can be connected via this connector to communicate with the
ventilator.
Wired network connector Connects with a PC to perform software upgrading.
WIFI connector Connects with external medical and information device
(1)Upgrades the software for ventilator.
(2)Exports captured screen, export configuration information and
historical data (such as patient data, alarm log, calibration table).
USB connector
(3)Transfers configuration data between machines of the same type.
(4)Provides power to the electronic nebulizer.
(5)Connects the mouse.
External display device
Supporting the connection with the external display devices.
connector
Nurse call connector Connects to the hospital’s nurse call system.

TABLE B-4 Physical Specifications

B.5 Pneumatic System Specifications


HIGH-PRESSURE O2 SUPPLY
Gas supply pressure range 280kPa to 650kPa
Input connector NIST or DISS
Maximum flow 180 L/min

LOW-PRESSURE O2 SUPPLY
Gas supply pressure range ≤ 100 kPa
Input connector Quick connector which supports self sealing
Flow ≤ 15 L/min
INSPIRATION MODULE
External connector of the
Coaxial 15 mm/22 mm conical connector
inspiratory end
Safety pressure of the The airway pressure is less than 125 cmH2O in normal or a single fault
breathing system condition.
Response time to change
in FiO2 setting from
21% to 90% O2 ≤ 90 s for TV=500 mL, f=10 /min, I:E=1:2
(measured at the patient ≤ 120 s for TV=150 mL, f=20 /min, I:E=1:2
wye)
SYSTEM COMPLIANCE AND RESISTANCE
Disposable tubing (including adult disposable patient tubing and
Compliance excluding expiratory port): ≤ 4 mL/cmH2O;
Reusable tubing (including adult reusable patient tubing and
excluding expiratory port): ≤ 2 mL/cmH2O.
Not greater than 6 cmH2O at 60 L/min flow (including adult patient
tubing and expiratory port)
Inspiratory resistance
Not greater than 6 cmH2O at 30 L/min flow (including adult patient
tubing and expiratory port)
Not greater than 6 cmH2O at 60 L/min flow (including adult patient
tubing and expiratory port)
Expiratory resistance
Not greater than 6 cmH2O at 30 L/min flow (including adult patient
tubing and expiratory port)
MAXIMUM GAS SUPPLY RATE

Operator’s Manual of Ventilator B-5


Ventilator Specifications Product Specifications

Maximum gas supply rate Not lower than 280 L/min.

LEAKAGE
Not greater than 200 mL/min@50 cmH2O
Leakage
Not greater than 100 mL/min@40 cmH2O

TABLE B-5 Pneumatic System Specifications

B.6 Ventilator Specifications


CONTROLLED PARAMETERS
Parameter Range Step Unit
CPAP 4 to 30 1 cmH2O
IPAP 4 to 50 1 cmH2O
Psupp 4 to 50 1 cmH2O
Pbackup 4 to 50 1 cmH2O
EPAP 4 to 30 1 cmH2O
O2% 21 to 100 1 vol.%
TV 50 to 2500 5 mL
O2 therapy flow 2 to 80 1 L/min
f 1 to 60 1 /min
fbackup 1 to 60 1 /min
Tinsp 0.20 to 5.00 0.05 s
Pmin 5 to 35 1 cmH2O
Pmax 6 to 50 1 cmH2O
TVmax 200 to 3500 5 mL
PPV% OFF, 10 to100 1 %
Max R OFF, 2 to100 1 cmH2O/(L/s)
Max E OFF, 10 to100 1 cmH2O/L
Tramp 1 to 60 1 min
Tslope 1 to 6 1 /
P-Flex OFF, 1 to 3 1 /
Normal, 1 to 6
Trigger 1 /
Normal: EasySyncTM function is on.
-2, -1, Normal, 1 to 6
E-Cycle 1 /
Normal: EasySyncTM function is on.
EPAPmax 4 to 30 1 cmH2O
EPAPmin 4 to 30 1 cmH2O

MONITORED PARAMETERS
Parameter Range Resolution Unit
Ppeak 0 to 100 Absolute value < 10: 0.1; cmH2O
PEEP 0 to 100 Absolute value ≥ 10: 1 cmH2O
O2% 15 to 100 1 vol.%
TVe 0 to 3500 (BTPS) 1 mL
O2 therapy flow 0 to 100 0.1 L/min
MVe 0 to 100 (BTPS) 0.1 L/min

B-6 Operator’s Manual of Ventilator


Product Specifications Ventilator Accuracy

ftotal 0 to 120 1 /min


Pt.leak 0 to 200 0.1 L/min
Tot.leak 0 to 200 0.1 L/min
Pt.Trig 0 to 100 1 %
Ti/Ttot 0 to 91 1 %
PEF 0 to 180 0.1 L/min
ROX 1 to 100 0.01 /

PesI -40 to 99 Absolute value < 10: 0.1; cmH2O


Absolute value ≥ 10: 1
PesE -40 to 99 Absolute value < 10: 0.1; cmH2O
Absolute value ≥ 10: 1
ΔPes -99 to 99 Absolute value < 10: 0.1; cmH2O
Absolute value ≥ 10: 1
PtpI -99 to 99 Absolute value < 10: 0.1; cmH2O
Paux Absolute value ≥ 10: 1
PtpE -99 to 99 Absolute value < 10: 0.1; cmH2O
Absolute value ≥ 10: 1
ΔPtp -99 to 99 Absolute value < 10: 0.1; cmH2O
Absolute value ≥ 10: 1
PTPes 0 to 100 0.1 cmH2O*s
PTPes/
0 to 1000 0.1 cmH2O*s/min
min
PEEPi 0 to 30 Absolute value < 10: 0.1; cmH2O
Absolute value ≥ 10: 1

TABLE B-6 Ventilator Specifications

B.7 Ventilator Accuracy


CONTROL ACCURACY
CPAP ± (2 cmH2O + 4% of set value)
IPAP ± (2 cmH2O + 4% of set value)
Psupp ± (2 cmH2O + 4% of set value)
Pbackup ± (2 cmH2O + 4% of set value)
EPAP ± (2 cmH2O + 4% of set value)
O2% ± 5 vol.%
TV ±20 ml or ± 15% of set value, whichever is greater.
O2 therapy flow ±2 L/min or ± 15% of set value, whichever is greater.
f ± 1/min
fbackup ± 1/min
Tinsp ± 0.03 s
Pmin ± (2 cmH2O + 4% of set value)
Pmax ± (2 cmH2O + 4% of set value)
TVmax ± 15% of set value
PPV% ±10% (absolute error)
±2 cmH2O/(L/s) when the setting range is less than 10 cmH2O/
Max R (L/s);
±10 cmH2O/(L/s) in other setting ranges.

Operator’s Manual of Ventilator B-7


Ventilator Accuracy Product Specifications

Max E ±10 cmH2O/L


Tramp ±1 min
EPAPmax ± (2 cmH2O + 4% of set value)
EPAPmin ± (2 cmH2O + 4% of set value)

MONITORING ACCURACY
Ppeak ±(2 cmH2O + 4% of actual reading)
PEEP ±(2 cmH2O + 4% of actual reading)
O2% ±(2.5 vol.% + 2.5% of actual reading)
TVe ±10 mL or ±15% of actual reading, whichever is greater.
±5 L/min or ± 15% of actual reading, whichever is greater
O2 therapy flow
(BTPS).
MVe ±0.3 L/min or ± 15% of actual reading, whichever is greater.
ftotal ±1 /min or ± 5% of actual reading, whichever is greater.
0 L/min to 100 L/min: ±5 L/min or ± 20% of actual reading,
Pt.leak whichever is greater.
Not defined above 100 L/min.
0 L/min to 100 L/min: ±5 L/min or ± 20% of actual reading,
Tot.leak whichever is greater.
Not defined above 100 L/min.
Pt.Trig ±10% (absolute error)
Ti/Ttot ±5% (absolute error)
PEF ±5 L/min or ± 20% of actual reading, whichever is greater.
ROX ±2 or ±10% of actual value, whichever is greater.
PesI ±(2 cmH2O + 4% of actual reading)
PesE ±(2 cmH2O + 4% of actual reading)
ΔPes ±(2 cmH2O + 4% of actual reading)
PtpI ±(2 cmH2O + 4% of actual reading)
Paux PtpE ±(2 cmH2O + 4% of actual reading)
ΔPtp ±(2 cmH2O + 4% of actual reading)
PTPes ±10 cmH2O*s or ±20% of actual value, whichever is greater.
±10 cmH2O*s/min or ± 20% of actual value, whichever is
PTPes/min
greater.
PEEPi ±(2 cmH2O + 4% of actual reading)

TABLE B-7 Ventilator Accuracy

B-8 Operator’s Manual of Ventilator


Product Specifications Alarms

B.8 Alarms
B.8.1 Settable Alarms

ALARM SETTINGS
Adjustment
Parameter Range Note
step
High alarm limit 10cmH2O to 55 cmH2O
Paw 1 cmH2O
Low alarm limit OFF, 1 cmH2O to 50 cmH2O
High alarm limit OFF, 50mL to 4000 mL
TVe 5 mL Set the high alarm
Low alarm limit OFF, 10 mL to 3995 mL limit to be greater
High alarm limit OFF, 2 /min to 120 /min than low alarm
ftotal 1 /min limit.
Low alarm limit OFF, 1 /min to 119 /min
High alarm limit OFF, 1 L/min to 100 L/min
MV 0.1 L/min
Low alarm limit OFF, 0.5 L/min to 99.5 L/min
High alarm limit
(low-pressure 20 vol.% to 100 vol.% Set the high alarm
oxygen) limit to be greater
O2% 1 vol.%
Low alarm limit than low alarm
(low-pressure 18 vol.% to 98 vol.% limit.
oxygen)
Time range for apnea alarms: OFF, 5s to 60s; step: 1s; error: ±1 s.

TABLE B-8 Settable Alarms

B.8.2 Built-in Alarms

ALARM SETTINGS ALARM CONDITION NOTE


High alarm limit
min (set O2% + max (7 vol.%, set O2%*10%),
(high-pressure
100 vol.%)) Set the high alarm
oxygen)
O2% limit to be greater
Low alarm limit
max (18 vol.%, set O2% - max (7 vol.%, set than low alarm limit.
(high-pressure
O2%*10%))
oxygen)

TABLE B-9 Built-in Alarms

B.9 Special Function


FUNCTION
Auxiliary pressure function
O2 ↑

TABLE B-10 Special Function

Operator’s Manual of Ventilator B-9


CO2 Module Product Specifications

B.10 CO2 Module


CO2 MODULE
Measurement mode Sidestream
0.0 vol.% to 5.0 vol.% (0 mmHg to 40 mmHg): ±0.25 vol.% (2 mmHg)
Range and accuracy 5.0 vol.% to 10.0 vol.% (41 mmHg to 76 mmHg) (excluding 5.0 vol.%): ± 5% of
of CO2 actual reading
measurement 10.0 vol.% to 20.0 vol.% (77 mmHg to 152 mmHg) (excluding 10.0 vol.%): ±
10% of actual reading
Measure accuracy The test method of the standard ISO 80601-2-55 can ensure the measurement
drift accuracy meets the requirement in this table.
120 mL/min with adult/pediatric watertrap and accessories;
Sampling rate Control accuracy: ±15% of the setting value or ±15 mL/min, whichever is
greater.
Total response time
Adult/pediatric watertrap and sampling line are used: < 5.5 s @ 120 mL/min.
of system
Rise time Adult/pediatric watertrap and sampling line are used: <300 ms @ 120 mL/min.
Adult/pediatric watertrap: ≥ 26 h@120 mL/min.
Experiment condition: sampling gas temperature: 37 ºC, ambient temperature:
Cleaning time for
23 ºC, relative humidity of sampling gas: 100%.
watertrap
Watertrap cleaning time ≥ 24h or 48h means that the liquid level won't
exceed the max line within 24h or 48h.

TABLE B-11 CO2 Module

CO2 ALARM LIMIT RANGE ADJUSTMENT STEP NOTE


EtCO2 high alarm limit 2 mmHg to 152 mmHg The higher limit must be
1mmHg greater than the lower
EtCO2 low alarm limit 0 mmHg to 150mmHg limit

TABLE B-12 CO2 Alarm Limit

CO2 ENVIRONMENT SPECIFICATIONS


Relative humidity Barometric pressure
Item Temperature (ºC)
(non-condensible) (kPa)
Operation 5 to 40 10% to 95% R.H. 62 to 106
Storage -20 to 60 10% to 95% R.H. 50 to 106

TABLE B-13 CO2 Environment Specifications

B.11 SpO2 Module


SPO2
*Measurement accuracy verification: The SpO2 accuracy has been verified in human experiments by
comparing with arterial blood sample reference measured with a CO-oximeter. Pulse oximeter
measurements are statistically distributed and about two-thirds of the measurements are expected
to come with in the specified accuracy range compared to CO-oximeter measurements.
Measurement range 0% to 100%
Resolution 1%
70% to 100%: ± 2%;
Accuracy
0 to 69%: not defined.
Data update period ≤ 30 s

B - 10 Operator’s Manual of Ventilator


Product Specifications SpO2 Module

Refreshing rate ≤2
*Studies were performed to validate the accuracy of Pulse Oximeter with SpO2 sensors by contrast
with a CO-Oximeter. The statistical analysis of data of this study shows the accuracy (Arms) is within
the stated accuracy specification. Please see the following table.
SENSOR TYPE TOTAL DATA ARMS
512F (adult, finger type, reusable) 10 (4 male&6 female) 200 pairs 1.91%
512H (pediatric, finger type, reusable) 10 (0 male&10 female) 200 pairs 1.95%
The Pulse Oximeter with neonatal SpO2 sensors was also validated on adult subjects.

SKIN COLOR GENDER NUMBER AGE (YEARS) HEALTH


Male 1
Black
Female 1
26±3.14 Healthy
Male 3
Yellow
Female 9

PR
Measurement range 20 1/min to 300 1/min range:
Resolution 1 1/min
Accuracy ±3 1/min

PI
Measurement range 0.05% to 20%
0.05% to 9.99%: 0.01%
Resolution
10.0% to 20.0%: 0.1%
Update cycle SpO2 (70% to 100%): ≤ 30 s
PR (20 1/min to 300 1/min): ≤ 30 s

TABLE B-14 SpO2 Module

SPO2 ALARM LIMITS RANGE ADJUSTMENT STEP NOTE


SpO2 high alarm limit 2% to 100% The high limit must be
greater than the low
SpO2 low alarm limit 0% to 98% 1% limit.
Desat alarm 0% to 98% /
PR high alarm limit 17 1/min to 300 1/min The high limit must be
1 1/min greater than the low
PR low alarm limit 15 1/min to 298 1/min limit.

TABLE B-15 SpO2 Alarm Limit

Operator’s Manual of Ventilator B - 11


SpO2 Module Product Specifications

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B - 12 Operator’s Manual of Ventilator


C.0 EMC

EMC ...................................................................................................................................................................................................................C-2
Radio Regulatory Compliance ..........................................................................................................................................................C-6

Operator’s Manual of Ventilator C-1


EMC EMC

C.1 EMC
This equipment is compliance with IEC 60601-1-2: 2014 for EMC.

The essential performance verified during the immunity testing comprise of TVi control accuracy, TVi
monitoring accuracy, CO2 monitoring accuracy, O2 control accuracy, O2 monitoring accuracy, PEEP
control accuracy, PEEP monitoring accuracy, and SpO2 monitoring accuracy.

NOTE: Using accessories other than those specified may result in increased
electromagnetic emission or decreased electromagnetic immunity of
the equipment.

NOTE: The ventilator or its components should not be used adjacent to or


stacked with other equipment. If adjacent or stacked use is necessary,
the ventilator or its components should be observed to verify normal
operation in the configuration in which it will be used.

NOTE: The ventilator needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information
provided below.

NOTE: Use of portable or mobile communications devices can degrade the


performance of the equipment.

WARNING: Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in
increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.

WARNING: Use of this equipment adjacent to or stacked with other device should
be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other device should be observed to
verify that they are operating normally.

WARNING: Portable RF communications equipment (including peripherals such as


antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to any part of the this equipment, including cables
specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.

WARNING: Other devices may interfere with this equipment even though they
meet the requirements of CISPR.

WARNING: When the input signal is below the minimum amplitude provided in
technical specifications, erroneous measurements could result.

C-2 Operator’s Manual of Ventilator


EMC EMC

GUIDANCE AND MANUFACTURE’S DECLARATION - ELECTROMAGNETIC EMISSIONS


This equipment is intended for use in the electromagnetic environment specified below. The customer or
the user of this equipment should assure that it is used in such an environment.

EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT - GUIDANCE


RF emissions Group 1 This equipment uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions Class B This equipment is suitable for use in all establishments,
CISPR 11 including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emissions Class A
IEC 61000-3-2
Voltage fluctuations/ Complies
flicker emissions
IEC 61000-3-3
TABLE C-1

GUIDANCE AND MANUFACTURE’S DECLARATION - ELECTROMAGNETIC IMMUNITY


This equipment is suitable for use in the electromagnetic environment specified below. The customer or
the user of this equipment should assure that it is used in such an environment.

IMMUNITY IEC 60601 TEST ELECTROMAGNETIC


TEST LEVEL COMPLIANCE LEVEL ENVIRONMENT - GUIDANCE
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood,
discharge (ESD) ±15kV air ±15kV air concrete or ceramic tile. If floors
IEC 61000-4-2 are covered with synthetic
material, the relative humidity
should be at least 30%.
Electrical fast ±2 kV for power ±2 kV for power supply lines Mains power quality should be
transient/burst supply lines ±1 kV for input/output lines that of a typical commercial or
IEC 61000-4-4 ±1 kV for input/ (length greater than 3 m) hospital environment.
output lines
(length greater than
3 m)
Surge ±1 kV line(s) to line(s) ±1 kV line(s) to line(s) Mains power quality should be
IEC 61000-4-5 ±2 kV line(s) to earth ±2 kV line(s) to earth that of a typical commercial or
hospital environment.
Voltage dips 0 % UT for 0.5 cycle 0 % UT for 0.5 cycle Mains power quality should be
and Voltage that of a typical commercial or
interruptions 0 % UT for 1 cycle and 0 % UT for 1 cycle and 70 % hospital environment. If the
IEC 61000-4-11 70 % UT for 25/30 UT for 25/30 cycles user of our product requires
continued operation during
cycles
power mains interruptions, it is
recommended that our
0 % UT for 250/300 0 % UT for 250/300 cycle
product be powered from an
cycle
uninterruptible power supply
or a battery.
TABLE C-2

Operator’s Manual of Ventilator C-3


EMC EMC

RATED power 30 A/m 30 A/m Power frequency magnetic


frequency fields should be at levels
magnetic fields characteristic of a typical
IEC 61000-4-8 location in a typical commercial
or hospital environment.
Note: UT is the AC. mains voltage prior to application of the test level.

TABLE C-2

GUIDANCE AND DECLARATION - ELECTROMAGNETIC IMMUNITY


This equipment is suitable for use in the electromagnetic environment specified below. The customer or
the user of this equipment should assure that it is used in such an environment.

IMMUNITY COMPLIANCE ELECTROMAGNETIC ENVIRONMENT -


TEST IEC 60601 TEST LEVEL LEVEL GUIDANCE
Conduced RF IEC 3 Vrms 3 Vrms (V1) Portable and mobile RF communications
61000-4-6 150k to 80 MHz equipment should be used no closer to any
part of the device, including cables, than
6 Vrms 6 Vrms (V2)
the recommended separation distance
in ISM bands and
calculated from the equation applicable to
amateur radio bandsa the frequency of the transmitter.
between 0.15 MHz and Recommended separation distance:
80 MHz
 3 .5 
d =  P
 V 1 
Radiated RF EM 3V/m 3 V/m (E1)
fields 80 MHz to 2.7 GHz 150kHz to 80 MHz
IEC 61000-4-3 (for SpO2 performance)
 3 .5 
d =   P
 E1  80 MHz to 800 MHz
10V/m 10 V/m  7 
80 MHz to 2.7 GHz (for d =   P
 E1 800 MHz to 2.7 GHz
ventilator function)
where P is the maximum output power
rating of the transmitter in watts (W)
Proximity fields 27 V/m 27 V/m according to the transmitter manufacturer
from RF wireless 380 MHz to 390 MHz and d is the recommended separation
communications
distance in meters (m)b.
equipment
28 V/m 28 V/m Field strengths from fixed RF transmitters,
IEC61000-4-3
430 MHz to 470 MHz, as determined by an electromagnetic site
800 MHz to 960 MHz, surveyc, should be less than the compliance
1700 MHz to 1990 MHz, level in each frequency range d .
2400 MHz to 2570 MHz Interference may occur in the vicinity of
9 V/m 9 V/m equipment marked with the following
704 MHz to 787 MHz,
5100 MHz to 5800 MHz
symbol: .
TABLE C-3

C-4 Operator’s Manual of Ventilator


EMC EMC

NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE: These guidelines may not apply in all situations. Electromagnetic


propagation is affected by absorption and reflection from structures,
objects and people.
a. The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to
6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0
MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07
MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0
MHz to 54.0 MHz.
b. Compliance level in the ISM frequency bands between 150 kHz to 80 MHz and in the frequency
range 80 MHz to 2.7 GHz are intended to decrease the likelihood that portable/ mobile
communication equipment could cause interference if it is inadvertently brought into patient
areas. For this reason, an additional factor of 10/3 is used in calculating the recommended
separation distance for transmitters in these frequency ranges.
c. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which this equipment is used exceeds the applicable RF
compliance level above, this equipment should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the device.
d. Over the frequency ranges 150 kHz to 80 MHz, field strengths should be less than 3V/m.
TABLE C-3

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF,


COMMUNICATIONS EQUIPMENT AND THIS EQUIPMENT
This equipment is intended for use in an electromagnetic environment in which radiated RF disturbance
are controlled. The customer or the user of this equipment can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and this equipment as recommended below, according to the maximum output power of
the communication equipment.

SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER (M)


150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
RATED MAXIMUM
 3 .5   3 .5   7 
OUTPUT POWER OF
d = P d =  P d =  P
 V 1 
TRANSMITTER
WATTS (W)  E1   E1 
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.20 1.20 2.30
10 3.80 3.80 7.30
100 12.00 12.00 23.00
For transmitters at a maximum output power not listed above, the recommended separation distanced in
meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P
is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.

NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE: These guidelines may not apply in all situations. Electromagnetic


propagation is affected by absorption and reflection from structures,
objects and people.
TABLE C-4

Operator’s Manual of Ventilator C-5


Radio Regulatory Compliance EMC

C.2 Radio Regulatory Compliance


WiFi Parameters

Operating Frequency Band (MHz) 2400 to 2483.5


Modulation DSSS and CCK
Transmitter Output Power (dBm) <20 (Avg)
<30 (Peak)
TABLE C-5

WARNING: Keep a distance of at least 20cm away from the ventilator when WiFi
function is in using.

C-6 Operator’s Manual of Ventilator


D.0 Alarm Messages

Physiological Alarms..............................................................................................................................................................................D-2
Technical Alarms ......................................................................................................................................................................................D-5

Operator’s Manual of Ventilator D-1


Physiological Alarms Alarm Messages

This chapter lists physiological and technical alarm messages:

Note that in this chapter:

• Column P stands for the default alarm level: H for high, M for medium and L for low.
• Corresponding actions are given for each alarm message. If the problem persists after the
actions have been taken, contact a service personnel.

D.1 Physiological Alarms


ALARM MESSAGES P CAUSE AND ACTION
The airway pressure exceeds the set pressure high alarm limit.
1. Check the patient and ventilation parameter settings.
Paw Too High H 2. Check the patient tubing for occlusion.
3. Click the button to adjust the Paw high alarm limit if
necessary.
The airway pressure is lower than the set pressure low alarm
limit.

Paw Too Low H 1. Check the patient and ventilation parameter settings.
2. Check the patient tubing for leakage or disconnection.
3. Click the button to adjust the Paw low alarm limit if
necessary.
The triggering period adopts the dynamic delay strategy
(different delay periods are set according to the difference
between the MVe monitored value and the MV high alarm
limit), and the MVe monitored value can last for at most 4
MVe Too High H mechanical ventilation cycles and is greater than the MV high
alarm limit.
1. Check the patient and ventilation parameter settings.
2. Click the button to adjust the MV high alarm limit if
necessary.
The triggering period adopts the dynamic delay strategy
(different delay periods are set according to the difference
between the MVe monitored value and the MV low alarm
limit), and the MVe monitored value can last for at most 4
mechanical ventilation cycles and is lower than the MV low
MVe Too Low H alarm limit.
1. Check the patient and ventilation parameter settings.
2. Check the patient tubing for leakage or occlusion.
3. Click the button to adjust the MV low alarm limit if
necessary.
The triggering period adopts the dynamic delay strategy
(different delay periods are set according to the difference
between the TVe monitored value and the TVe high alarm
limit), and the TVe monitored value can last for at most 6
TVe Too High M mechanical ventilation cycles and is greater than the TVe high
alarm limit.
1. Check the patient and ventilation parameter settings.
2. Click the button to adjust the TVe high alarm limit if
necessary.
TABLE D-1 Physiological Alarms

D-2 Operator’s Manual of Ventilator


Alarm Messages Physiological Alarms

ALARM MESSAGES P CAUSE AND ACTION


The triggering period adopts the dynamic delay strategy
(different delay periods are set according to the difference
between the TVe monitored value and the TVe low alarm
limit), and the TVe monitored value can last for at most 4
mechanical ventilation cycles and is lower than the TVe low
TVe Too Low M alarm limit.
1. Check the patient and ventilation parameter settings.
2. Check the patient tubing for leakage or occlusion.
3. Click the button to adjust the TVe low alarm limit if
necessary.
The triggering period adopts the dynamic delay strategy
(different delay periods are set according to the difference
between the ftotal monitored value and the ftotal high alarm
limit), and the ftotal monitored value can last for at most 4
mechanical ventilation cycles and is greater than the ftotal
ftotal Too High M high alarm limit.
1. Check the patient and ventilation parameter settings.
2. Check the patient tubing for leakage and clear water build-
up.
3. Click the button to adjust the ftotal high alarm limit if
necessary.
The triggering period adopts the dynamic delay strategy
(different delay periods are set according to the difference
between the ftotal monitored value and the ftotal high alarm
limit), and the ftotal monitored value can last for at most 4
ftotal Too Low M mechanical ventilation cycles and is lower than the ftotal low
alarm limit.
1. Check the patient and ventilation parameter settings.
2. Click the button to adjust the ftotal low alarm limit if
necessary.
The inspired O2 concentration has been greater than the FiO2
high alarm limit for at least 30s.

FiO2 Too High H 1. Check the HEPA filter for occlusion.


2. Calibrate the O2 sensor.
3. Click the button to adjust the FiO2 low alarm limit (low-
pressure oxygen supply only) if necessary.
The inspired O2% has been lower than the FiO2 low alarm limit
for at least 30 s or is less than 18%.
1. Check connection with O2 supply.
FiO2 Too Low H 2. Ensure the oxygen supply pressure ranges from 280 kPa to
650 kPa.
3. Calibrate the O2 sensor.
4. Click the button to adjust the FiO2 low alarm limit (low-
pressure oxygen supply only) if necessary.
The monitored parameter value exceeds the alarm limit.

EtCO2 Too High M 1. Check the patient and ventilation parameter settings.
2. Click the button to adjust the EtCO2 high alarm limit if
necessary.
TABLE D-1 Physiological Alarms

Operator’s Manual of Ventilator D-3


Physiological Alarms Alarm Messages

ALARM MESSAGES P CAUSE AND ACTION


The monitored parameter value exceeds the alarm limit.

EtCO2 Too Low M 1. Check the patient and ventilation parameter settings.
2. Click the button to adjust the EtCO2 low alarm limit if
necessary.
The SpO2 value is greater than the high alarm limit.
1. Check the patient and ventilation parameter settings.
SpO2 Too High M 2. Check the patient’s inspiratory O2%.
3. Click the button to adjust the SpO2 high alarm limit if
necessary.
The SpO2 value is lower than the low alarm limit.
1. Check the patient and ventilation parameter settings.
SpO2 Too LOW M 2. Check the patient’s inspiratory O2%.
3. Click the button to adjust the SpO2 low alarm limit if
necessary.
The SpO2 value is lower than the Desat alarm limit.
1. Check the patient and ventilation parameter settings.
SpO2 Desat H 2. Check the patient’s inspiratory O2%.
3. Click the button to adjust the Desat high alarm limit if
necessary.
PR value exceeds the high alarm limit.

PR Too High M 1. Check the patient and ventilation parameter settings.


2. Click the button to adjust the PR high alarm limit if
necessary.
PR value is lower than the low alarm limit.
PR Too LOW M 1. Check the patient and ventilation parameter settings.
2. Click the button to adjust the PR low alarm limit if necessary.
The patient’s pulse signal is too weak, and the system cannot
perform analysis.
No Pulse H
1. Check the patient's condition.
2. Check the connection of the SpO2 sensor.
The time of failure to detect respiration exceeds Tapnea.
1. Check the patient and ventilation parameter settings.
Apnea H 2. Check the patient tubing for disconnection.
3. Click the button to adjust Tapnea high alarm limit if
necessary.
The time of failure to detect respiration by the CO2 module
exceeds Tapnea.
Apnea CO2 M 1. Check the patient and ventilation parameter settings.
2. Check the connections of CO2 module sampling device.
3. Click the button to adjust Tapnea alarm limit if necessary.
TABLE D-1 Physiological Alarms

D-4 Operator’s Manual of Ventilator


Alarm Messages Technical Alarms

ALARM MESSAGES P CAUSE AND ACTION


The time of failure to detect respiration exceeds Tapnea and
the backup ventilation is enabled.
Check the patient and ventilation parameter settings.
Backup Vent H
NOTE: If two consecutive spontaneous breaths are
detected, the ventilator will exit the backup
ventilation automatically.
Backup Ventilation Exit the backup ventilation mode. No more operations
L
Ended needed.
TABLE D-1 Physiological Alarms

D.2 Technical Alarms


ALARM MESSAGES P CAUSE AND ACTION
The real-time clock requires a reset.
Please Reset Date
L 1. Please reset the date and time.
and Time
2. Contact the specified service personnel if the issue persists.
Monitored PEEP exceeds PEEP + 5 cmH2O within any fully
mechanical ventilation cycle.
PEEP Too High H 1. Check the patient and ventilation parameter settings.
2. Check and clean the patient tubing.
3. Check and clean the exhalation port.
Patient’s PEEP is less than the setting value to a certain extent.
PEEP Too Low M 1. Check the patient tubing for leakage or disconnection.
2. Check whether the exhalation port is properly installed.
Tube is occluded.
Airway
H 1. Check and clean the patient tubing.
Obstructed?
2. Check and clean the exhalation port.
Tube is disconnected.
Tube
H 1. Check the patient tubing for disconnection.
Disconnected?
2. Check whether the exhalation port is properly installed.
O2 supply pressure is greater than the threshold value.
High O2 Supply 1. Check connection with O2 supply.
H
Pressure 2. Ensure the O2 supply pressure ranges from 280 kPa to 650
kPa.
Oxygen is in short supply at the gas supply inlet and not
enough to support proper operation of the machine.
O2 Supply Failure H 1. Check connection with O2 supply.
2. Ensure the oxygen supply pressure ranges from 280 kPa to
650 kPa.
O2 Sensor The O2 sensor is not connected.
L
Unconnected Connect the O2 sensor.
TABLE D-2 Technical Alarms

Operator’s Manual of Ventilator D-5


Technical Alarms Alarm Messages

ALARM MESSAGES P CAUSE AND ACTION


The O2 sensor is used up.
Replace O2 sensor M 1. Replace the O2 sensor.
2. Enter the standby mode and calibrate the O2 sensor.
The O2 sensor is not calibrated or the calibration data is lost,
Please calibrate O2 and requires calibration again.
L
sensor 1. Enter the standby mode and calibrate the O2 sensor.
2. Contact the specified service personnel if the issue persists.
Please perform Please perform pressure calibration.
pressure H Contact the specified service personnel.
calibration.
Please perform flow calibration.
Please perform
H 1. Enter the standby mode and calibrate flow sensors.
prop calibration.
2. Contact the specified service personnel if the issue persists.
Insp. gas temperature exceeds 45 degrees.
Insp. Gas Temp Too 1. Use another device for ventilation.
H
High 2. Restart the ventilator.
3. Contact the specified service personnel if the issue persists.
The HEPA filter is occluded.
Replace HEPA
L 1. Replace the HEPA filter of blower module.
Filter
2. Contact the specified service personnel if the issue persists.
Paw ≥ EPAP+ 15 cmH2O for consecutive 15 seconds.
Sustained Airway 1. Check the patient and ventilation parameter settings.
H
Pressure 2. Check and clean the patient tubing.
3. Check and clean the exhalation port.
Paw in the inspiratory stage is less than the setting value to a
Pinsp Not certain extent.
L
Achieved 1. Check the patient and ventilation parameter settings.
2. Check the patient tubing for leakage or disconnection.
The target pressure is higher than the Pmax in PPV mode.
PPV Pressure Too 1. Check the patient and ventilation parameter settings.
H
High 2. Check the patient tubing for leakage or disconnection.
3. Adjust PPV%, Max E or Max R if necessary.
The monitored TVe is higher than TVmax in PPV mode.

PPV TV Too High H 1. Check the patient and ventilation parameter settings.
2. Check the patient tubing for leakage or disconnection.
3. Adjust PPV%, Max E or Max R if necessary.
The target pressure is greater than the Pmax setting in VAPS
VAPS: Target TV mode.
Not Achieved. L
Insufficient Pmax 1. Check the patient's condition.
2. Adjust Pmax if necessary.
The target pressure is less than the Pmin setting in VAPS
VAPS: Target TV mode.
Exceeded. Pmin L
Too High 1. Check the patient's condition.
2. Adjust Pmin if necessary.
TABLE D-2 Technical Alarms

D-6 Operator’s Manual of Ventilator


Alarm Messages Technical Alarms

ALARM MESSAGES P CAUSE AND ACTION


The total leakage of the patient and the tubing is low and the
patient may repeatedly inhale CO2.
1. Check the patient’s condition.
Low Leak-CO2 2. Check whether the outlet of patient tubing is blocked.
H
Rebreathing Risk 3. Check whether the mask is properly worn and the
exhalation port is properly installed.
4. Adjust the ventilation parameters, or replace the mask and
exhalation port type if necessary.
The proximal pressure sampling line on the patient or
Proximal Pressure ventilator side is disconnected.
H
Line Disconnected Check whether the proximal pressure sampling line is
disconnected.
Storage failure.
Storage Error M
Contact the specified service personnel.
Turbine blower temperature exceeds the threshold value.
1. Check if the operating ambient temperature of the machine
exceeds the maximum operating temperature.
Blower Temp Too 2. Check if the fan inlet and outlet are occluded. If yes, clear
H
High the foreign substance and dust.
3. Check the rotation of the fan. If it is abnormal, replace the
fan.
4. Contact the specified service personnel if the issue persists.
Blower fan failure.
Back Fan Failure M
Contact the specified service personnel.
Blower Technical Turbine blower temperature sensor failure.
M
Error 01 Contact the specified service personnel.
Blower Technical HEPA pressure sensor failure.
M
Error 02 Contact the specified service personnel.
The turbine blower temperature is too high and shutdown is
Blower Failure 03 H required.
Contact the specified service personnel.
Turbine blower failure.
Blower Failure 04 H
Contact the specified service personnel.
Buzzer failure.
Technical Error 04 L
Contact the specified service personnel.
Atmospheric pressure sensor failure.
Technical Error 05 M 1. Use another device for ventilation.
2. Contact the specified service personnel.
3-way valve failure.
Technical Error 07 M
Contact the specified service personnel.
Insp. temp sensor failure.
Technical Error 09 M
Contact the specified service personnel.
Power supply voltage error.
Device Failure 01 H
Contact the specified service personnel.
TABLE D-2 Technical Alarms

Operator’s Manual of Ventilator D-7


Technical Alarms Alarm Messages

ALARM MESSAGES P CAUSE AND ACTION


Memory error.
Device Failure 02 H
Contact the specified service personnel.
Power board selftest error.
Device Failure 03 H
Contact the specified service personnel.
Control module initialization error.

Device Failure 04 H 1. Use another device for ventilation.


2. Restart the ventilator.
3. Contact the specified service personnel if the issue persists.
Control module communication stop.

Device Failure 05 H 1. Use another device for ventilation.


2. Restart the ventilator.
3. Contact the specified service personnel if the issue persists.
Control module selftest error.
Device Failure 06 H
Contact the specified service personnel.
Pressure sensor failure.

Device Failure 09 H 1. Use another device for ventilation.


2. Restart the ventilator.
3. Contact the specified service personnel if the issue persists.
Total inspiratory limb failure.

Device Failure 12 H 1. Use another device for ventilation.


2. Restart the ventilator.
3. Contact the specified service personnel if the issue persists.
O2 limb failure.

Device Failure 13 H 1. Use another device for ventilation.


2. Restart the ventilator.
3. Contact the specified service personnel if the issue persists.
Power board communication stop.

Device Failure 19 H 1. Use another device for ventilation.


2. Restart the ventilator.
3. Contact the specified service personnel if the issue persists.
SpO2 module communication stop.
Device Failure 20 H
Contact the specified service personnel.
Pressure sensor zero point error.
Device Failure 21 H
Contact the specified service personnel.
Protecting module communication stop.
Device Failure 22 H
Contact the specified service personnel.
Protecting module selftest error.
Device Failure 23 H
Contact the specified service personnel.
Battery 1 Failure Failure in battery charging.
H
02 Contact the specified service personnel.
Battery 1 Failure Battery ageing.
H
03 Contact the specified service personnel.
TABLE D-2 Technical Alarms

D-8 Operator’s Manual of Ventilator


Alarm Messages Technical Alarms

ALARM MESSAGES P CAUSE AND ACTION

Battery 1 Failure Battery communication error.


H
04 Contact the specified service personnel.
Battery 1 Failure Battery failure.
H
05 Contact the specified service personnel.
Battery 2 Failure Failure in battery charging.
H
02 Contact the specified service personnel.
Battery 2 Failure Battery ageing.
H
03 Contact the specified service personnel.
Battery 2 Failure Battery communication error.
H
04 Contact the specified service personnel.
Battery 2 Failure Battery failure.
H
05 Contact the specified service personnel.
Battery Temp. The battery temperature is a bit high during discharging.
High. Connect Ext. M Connect the external power supply.
Pwr.
Battery Temp Battery temperature is too high during discharging and the
High. Syst maybe H system may shut down.
Down Connect the external power supply.
The current system is powered by a battery.
Battery in Use L
Connect the external power supply.
Low Battery. The remaining battery power is lower than a threshold.
Connect Ext. M 1. The available time of the internal battery is less than 5 min.
Power. 2. Connect the external power supply.
System DOWN. Battery runs up and the system will shut down in a few
Connect Ext. H minutes.
Power. Connect the external power supply immediately.
Battery The current system has no battery.
H
Undetected Contact the specified service personnel.
Fan failure.
Top Fan Failure M
Contact the specified service personnel.
CO2 Sensor High The sensor component temperature is too high (above 63 ℃ ).
L
Temp Contact the specified service personnel.
The sampling line is faulty or occluded.
CO2 Sampleline 1. Check the CO2 sampling line for occlusion.
L
Occluded 2. Replace the sampling line.
3. Replace the watertrap.
The watertrap is detached or improperly connected.
CO2 No Watertrap L
Please reinstall the watertrap.
The measured value of the parameter exceeds the applicable
measurement range (error range is included).
EtCO2 Overrange L
1. Click the button to zero the CO2 module.
2. Contact the specified service personnel if the issue persists.
TABLE D-2 Technical Alarms

Operator’s Manual of Ventilator D-9


Technical Alarms Alarm Messages

ALARM MESSAGES P CAUSE AND ACTION

CO2 Module CO2 module zero failed.


M
Failure 01 Contact the specified service personnel.
CO2 Module Error in initializing the CO2 module.
M
Failure 02 Contact the specified service personnel.
CO2 Module Error in selftest of the CO2 module.
M
Failure 03 Contact the specified service personnel.
CO2 Module CO2 hardware error.
M
Failure 04 Contact the specified service personnel.
CO2 Module CO2 module communication error.
M
Failure 05 Contact the specified service personnel.
Connected SpO2 sensor is disconnected from the patient
tubing (such as wire disconnection or short circuit).
SpO2 Sensor Off L
Check the connection between the SpO2 sensor and the
patient.
Failure in the SpO2 sensor (such as wire disconnection or short
Please Replace circuit).
M
SpO2 Sensor 1. Replace SpO2 sensor.
2. Contact the specified service personnel.
Main cable has disconnected from module. Connection
between sensor and main cable has disconnected.
SpO2 No Sensor L
Check the connection between the SpO2 sensor cable and the
ventilator, the SpO2 sensor cable and the SpO2 sensor.
The light to which the sensor is exposed is so bright that the
SpO2 Too Much sensor's photodetector is absorbing the surrounding light.
L
Light
Move the SpO2 sensor to a place with low light.
The SpO2 sensor cannot detect pulse signals (or the signals are
not complete).
SpO2 No Pulse L 1. Check the patient's condition.
2. Check SpO2 sensor and measurement site connection
3. Replace SpO2 sensor if the issue persists.
SpO2 module error or SpO2 initialization error.
SpO2 Module Error M 1.Replace SpO2 sensor.
2. Contact the specified service personnel.
Measured values of parameter SpO2 exceed the measurement
range.
SpO2 Overrange L
1. Replace SpO2 sensor.
2. Contact the specified service personnel.
Measured values of parameter PR exceed the measurement
range.
PR Overrange L
1. Replace SpO2 sensor.
2. Contact the specified service personnel.
Please calibrate Please calibrate the auxiliary pressure sensor.
auxiliary pressure H Contact the specified service personnel.
sensor
TABLE D-2 Technical Alarms

D - 10 Operator’s Manual of Ventilator


E.0 Factory Defaults

Ventilation Parameters .......................................................................................................................................................................... E-2


Setup ................................................................................................................................................................................................................E-2
Alarms .............................................................................................................................................................................................................. E-3
History.............................................................................................................................................................................................................. E-4
Other.................................................................................................................................................................................................................E-4

Operator’s Manual of Ventilator E-1


Ventilation Parameters Factory Defaults

E.1 Ventilation Parameters


CONTROLLED PARAMETERS DEFAULTS
O2% 21 vol.%
CPAP 4 cmH2O
IPAP 12 cmH2O
EPAP 4 cmH2O
f(Except T mode) 4 /min
Tinsp 1.30 s
Tslope 3
TV 500 ml
Psupp 12 cmH2O
Trigger Normal
E-Cycle Normal
P-Flex 3
f(T mode) 12 /min
Pmin 10 cmH2O
Pmax 25 cmH2O
TVmax 1000 mL
PPV% 30 %
Max E 15 cmH2O/L
Max R 4 cmH2O/L/s
AE OFF
EPAPmin 4 cmH2O
EPAPmax 9 cmH2O
Pbackup 12 cmH2O
fbackup 12 /min
Flow (O2 therapy) 25 L/min
O2% (O2 therapy) 21 vol.%

TABLE E-1 Ventilation Parameters

E.2 Setup
ITEM DEFAULTS
Menu: Setup: Ventilation: IBW/Height Height
Menu: Setup: Ventilation: Increase O2% during O2 ↑ 60 vol.%
Menu: Setup: O2 Sensor: Monitoring ON
Menu: Setup: CO2: Monitoring ON
Menu: Setup: CO2: BTPS Comp OFF
Menu: Setup: SpO2: Monitoring ON

E-2 Operator’s Manual of Ventilator


Factory Defaults Alarms

ITEM DEFAULTS
Menu: Setup: SpO2: Sensitivity Med
Menu: Setup: SpO2: Sweep Speed 25 mm/s
Menu: Setup: SpO2: Beat Volume 1
Menu: Screen: Brightness/
Day
Volume
Menu: Screen: Screen Setup: Waveform Count 3
Menu: Screen: Screen Setup: Waveform Type Curve
Menu: Screen: Screen Setup: Layout Setup Switch ON
Menu: System: Setup: Language/Unit: Language CHINESE
Menu: System: Setup: Language/Unit: Pressure Unit cmH2O
Menu: System: Setup: Language/Unit: CO2 Unit mmHg
Menu: System: Setup: Language/Unit: Height Unit cm
Menu: System: Setup: Language/Unit: Weight Unit Kg
Menu: System: Interface: Nurse Call: Switch OFF
Menu: System: Interface: Nurse Call: Signal Type Continuous
Menu: System: Interface: Nurse Call: Contact Type Normally Closed
High Alarms, Med
Menu: System: Interface: Nurse Call: Alarm Level
Alarms
Phys. Alarm, Tech.
Menu: System: Interface: Nurse Call: Alarm Type
Alarm
Menu: System: Interface: Network Type: Network Type LAN
Menu: System: Interface: LAN Setup: IP Config. Static
Menu: System: Interface: Central Station Setup: Network
OFF
disconnection alarm
Menu: System: Interface: Central Station Setup: Select CMS OFF
Menu: System: Interface: Information Security: Encryption Only Private
Connection Type Encryption
Menu: System: Interface: Serial: Protocol None

TABLE E-2 Setup

E.3 Alarms
ITEM DEFAULTS
Alarms: Vent Limits: Paw High Limit 50 cmH2O
Alarms: Vent Limits: Paw Low Limit OFF
Alarms: Vent Limits: MV High Limit OFF
Alarms: Vent Limits: MV Low Limit OFF
Alarms: Vent Limits: TVe High Limit OFF
Alarms: Vent Limits: TVe Low Limit OFF
Alarms: Vent Limits: ftotal High Limit 30 /min
Alarms: Vent Limits: ftotal Low Limit 10 /min

Operator’s Manual of Ventilator E-3


History Factory Defaults

ITEM DEFAULTS
Alarms: Vent Limits: Tapnea 15 s
Alarms: Module Limits: FiO2 High Limit 100 vol.%
Alarms: Module Limits: FiO2 Low Limit 21 vol.%
Alarms: Module Limits: EtCO2 High Limit 50 mmHg
Alarms: Module Limits: EtCO2 Low Limit 15 mmHg
Alarms: Module Limits: SpO2 High Limit 100%
Alarms: Module Limits: SpO2 Low Limit 90%
Alarms: Module Limits: PR High Limit 120 1/min
Alarms: Module Limits: PR Low Limit 50 1/min
Alarms: Module Limits: Desat 80%

TABLE E-3 Alarms

E.4 History
ITEM DEFAULTS
History: Graphic: Zoom 10 min
History: Graphic: Display Group All
History: Tabular: Interval 1 min
History: Tabular: Display Group All
History: Event Logbook: Filter All Events

TABLE E-4 History

E.5 Other
ITEM DEFAULTS
Menu: System: Setup: Date & Time Setup: Date Format YYYY-MM-DD
Menu: System: Setup: Date & Time Setup: 24 h ON
Menu: System: Setup: Date & Time Setup: DayLight Savings OFF
Ramp: Tramp 10 min
Paux: Paux OFF

TABLE E-5 Other

E-4 Operator’s Manual of Ventilator


F.0 Abbreviations, Symbols and
Measuring Units

Abbreviations .............................................................................................................................................................................................. F-2


Symbols .......................................................................................................................................................................................................... F-3
Measuring Unit........................................................................................................................................................................................... F-4

Operator’s Manual of Ventilator F-1


Abbreviations Abbreviations, Symbols and Measuring Units

F.1 Abbreviations
ABBREVIATIONS DESCRIPTION
AE Adaptive EPAP
BTPS Body Temperature and Pressure Saturated
CO2 Carbon Dioxide
CPAP Continuous Positive Airway Pressure
Desat Desaturation
E-Cycle Expiratory Cycle Sensitivity
EPAP Expiratory Positive Airway Pressure
EPAPmax The maximum EPAP
EPAPmin The minimum EPAP
EtCO2 End-tidal Carbon Dioxide
f Breathing Frequency
fbackup Backup Breathing Frequency
FiO2 Inspired Oxygen Concentration
Flow Flow
fspn Spontaneous Frequency
ftotal Total Breathing Frequency
I:E Inspiratory Time : Expiratory Time Ratio
IPAP Inspiratory Positive Airway Pressure
Max E Maximum Elastance
Max R Maximum Resistance
MVe Expired Minute Volume
O2 Oxygen
P-A/C Pressure-Assist/Control Ventilation
Paw Airway Pressure
Paw Airway Pressure
Pbackup Backup Pressure
PEEP Positive End-Expiratory Pressure
PEEPi Intrinsic PEEP
PEF Peak Expiratory Flow
ΔPes ΔOesophageal Pressure
PesE Expiratory Oesophageal Pressure
PesI Inspiratory Oesophageal Pressure
PI Perfusion Index
Pmax The maximum pressure to be applied
Pmin The minimum pressure to be applied
Ppeak Peak Inspiratory Pressure
PPV Proportional Pressure Ventilation
PPV% Percentage of PPV assist or gain

F-2 Operator’s Manual of Ventilator


Abbreviations, Symbols and Measuring Units Symbols

ABBREVIATIONS DESCRIPTION
PR Pulse Rate
Psupp Support Pressure
ΔPtp ΔTranspulmonary Pressure
PtpE Expiratory Transpulmonary Pressure
PTPes Oesophageal Pressure Time Product of 1 Breath
PTPes/min Oesophageal Pressure Time Product of 1 Minute
PtpI Inspiratory Transpulmonary Pressure
Pt.leak Patient Leak
Pt.Trig Percent of patient-triggered breaths
S Spontaneous Ventilation
S/T Spontaneous/Timed Ventilation
S/T+ Spontaneous/Timed Ventilation Plus
SpO2 Blood Oxygen Saturation
T Timed Ventilation
Ti max Maximum Time of Inspiration
Tinsp Time of Inspiration
Ti/Ttot Inspiration Time/Total Cycle Time
TVe/IBW Expired Tidal Volume Per Ideal Body Weight
Tot.leak Total Leak
Tslope Time of Pressure Rising
TV Tidal Volume
TVe Expired Tidal Volume
TVmax The maximum volume to be delivered
Trigger Trigger Sensitivity
VAPS Volume Assured Pressure Support Ventilation

TABLE F-1 Abbreviations

F.2 Symbols
SYMBOL DESCRIPTION SYMBOL DESCRIPTION
- minus, negative > greater than
% percentage ≤ smaller than or equal to
/ per, divided by, or ≥ greater than or equal to
≈ approximately ± plus or minus
^ power × multiplied by
+ plus, positive © copyright
= equal to ™ trademark
< smaller than ® registered trademark

TABLE F-2 Symbols

Operator’s Manual of Ventilator F-3


Measuring Unit Abbreviations, Symbols and Measuring Units

F.3 Measuring Unit


MEASURI MEASURIN
NG UNIT DESCRIPTION G UNIT DESCRIPTION
A ampere m meter
Ah ampere-hour mAh milliampere-hour
bpm breaths per minute mbar millibar
°C degree centigrade mg milligram
cc cubic centimeter min minute
cm centimeter ml, mL milliliter
cmH2O centimeter water-column mm millimeter
dB decibel mmHg millimeter mercury
°F Fahrenheit degree ms millisecond
g gram mV millivolt
hr hour mW milliwatt
Hz hertz ppm parts per million
hPa hectopascal s, sec second
inch inch V voltage
k thousand VA volt-ampere
kg kilogram VAC alternating current volt
kPa kilopascal Ω Ohm
psi pound per square inch μA microamp
L, l litre μV microvolt
lb pound W watt
nm nanometer

TABLE F-3 Measuring Unit

F-4 Operator’s Manual of Ventilator


PN:046-021084-00(1.0)

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