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ESV-3000 User Manual

The document provides detailed information about a ventilator, including its compliance with medical device regulations, user responsibilities, and safety information. It emphasizes the importance of adhering to the user manual for installation, operation, and maintenance to avoid malfunctions and safety hazards. Additionally, it outlines the structure of the manual, which includes chapters on safety, equipment description, operations, maintenance, and alarms.

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Alou Sidibé
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0% found this document useful (0 votes)
18 views90 pages

ESV-3000 User Manual

The document provides detailed information about a ventilator, including its compliance with medical device regulations, user responsibilities, and safety information. It emphasizes the importance of adhering to the user manual for installation, operation, and maintenance to avoid malfunctions and safety hazards. Additionally, it outlines the structure of the manual, which includes chapters on safety, equipment description, operations, maintenance, and alarms.

Uploaded by

Alou Sidibé
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Product Information

Product Name:Ventilator

Lifetime: 5 years

CE Mark

The product is marked with CE, as it conforms to European Council Directive for Medical

Devices (93/42/EEC), and meets basic requirements of appendix I in the directive.

This product is the TypeⅠ,Class B radio jamming protective equipment that complies with

the EN55011. It meets the requirements of EN60601-1-2 standard “Medical electrical

equipment-Electromagnetic compatibility”.

User’s responsibility
Please check the product and accessories firstly when you receive the product, make sure

it conform to the contract. If any damage to the package or the product is found before or

after opening the packing case, please contact the local office or the franchiser

immediately.

Users must perform the installation, operation, maintenance and carry out regular

inspection according to the instruction described in the manual. Replace the components

immediately if any damage, loss, distortion or contamination is found. Stop use when

I
malfunction occurs. Please contact the after service department of the Company for

repairing and replacing. Any change of the product is verboten without agreement from the

Company. The user must take responsibility for any malfunction which results from

non-compliance with the servicing requirements detailed in this manual or the service or

repairs are not performed by the personnel of the Company.

II
Preface
Description

This manual describes the intended use, function, installation, operation and maintenance

of the product. Personnel must make themselves familiar with the contents of this manual

and the machine’s function before using the product. When you begin to use the ventilator,

we deem that you have read the manual carefully.

In order to use the equipment accurately, effectively and avoid accidents, please read the

manual carefully and comply with it strictly, especially pay attention to the “Warning”,

“Caution” and “Note”.

The optional features may not be completely included in the manual, should you have any

questions, please contact the Company.

Please put the manual near the product so that you can easily fetch it at any time.

Illustration

The illustrations in the manual are only for reference, some settings and data may not be

consistent with the real display of the product; please refer to the real product.

Conventions

 Bold Italic: The quoted section.

 【Character】: The character string on the software interface or on the control

panel.

III
IV
Contents
PRODUCT INFORMATION.................................................................................................................. I

CE MARK................................................................................................................................................. I

USER’S RESPONSIBILITY................................................................................................................... I

PREFACE .............................................................................................................................................. III

CONTENTS.............................................................................................................................................V

CHAPTER 1 SAFETY INFORMATION................................................................................................1

1.1 WARNINGS .................................................................................................................................2


1.2 CAUTIONS ..................................................................................................................................5

CHAPTER 2 EQUIPMENT DESCRIPTION ........................................................................................8

2.1 BRIEF INTRODUCTION ................................................................................................................8


2.2 SYSTEM OVERVIEW ....................................................................................................................9
2.2.1 External pipeline connection diagram..............................................................................9
2.2.2 User screen diagram ........................................................................................................10
2.2.3 Ventilator rear view ............................................................................................................. 11
2.2.4 Side view diagram ...............................................................................................................12
2.3 POWER SUPPLY .........................................................................................................................12
2.4 BATTERY ..................................................................................................................................12
2.5 GAS SUPPLY ..............................................................................................................................13
2.6 SYSTEM SWITCH .......................................................................................................................14
2.7 USER SCREEN ...........................................................................................................................14
2.7.1 Start-up screen..................................................................................................................14
2.7.2 Standby screen .................................................................................................................15
2.7.3 Main menu .........................................................................................................................15
2.7.4 Function screen.................................................................................................................17
2.7.4.1 Modes settings...........................................................................................................................17
2.7.4.2 Measured Values........................................................................................................................18
2.7.4.3 Alarm setting .............................................................................................................................19
2.7.4.4 System settings ..........................................................................................................................19
2.7.4.5 System log .................................................................................................................................20
2.8 VENTILATION MODES ...............................................................................................................21
2.8.1 VCV mode..........................................................................................................................21
2.8.2 PCV mode..........................................................................................................................22
2.8.3 PSV mode..........................................................................................................................23
2.8.4 SIMV mode ........................................................................................................................23
2.8.5 DualPAP mode ..................................................................................................................24
2.8.6 SPONT mode ....................................................................................................................25
2.8.7 NPPV mode .........................................................................................................................25
2.8.8 PRVC mode .........................................................................................................................26

V
2.8.9 Standby mode ...................................................................................................................26
2.9 SPECIAL FUNCTION ...................................................................................................................27
2.9.1 Backup ventilation.............................................................................................................27
2.10 ALARM SYSTEM ........................................................................................................................27
2.10.1 General description ......................................................................................................27
2.10.2 Alarm limit setting .........................................................................................................29
2.10.3 Alarm silence.................................................................................................................29
2.10.4 Alarm reset ....................................................................................................................30

CHAPTER 3 DISASSEMBLING AND ASSEMBLING ....................................................................31

3.1 TROLLEY ..................................................................................................................................31


3.2 VENTILATOR SYSTEM ...............................................................................................................32
3.3 BATTERY MODULES ..................................................................................................................33
3.4 OXYGEN BATTERY ....................................................................................................................34
3.5 PATIENT SYSTEM .......................................................................................................................36
3.6 EXPIRATORY VALVE ..................................................................................................................37
3.7 POWER SUPPLY OUTLET ............................................................................................................38
3.8 CONNECTING THE GAS SUPPLY .................................................................................................38
3.9 HUMIDIFIER ..............................................................................................................................39

CHAPTER 4 PRE-USE CHECK .........................................................................................................42

4.1 SYSTEM CHECKING..........................................................................................................................42


4.2 ALARM TEST ...................................................................................................................................43
4.2.1 Preparations before alarm test ..........................................................................................43
4.2.2 High airway pressure alarm ...............................................................................................43
4.2.3 Low volume alarm ...............................................................................................................43
4.2.4 Low oxygen concentration alarm ......................................................................................44
4.2.5 Pipeline failure alarm ..........................................................................................................44
4.2.6 Power failure alarm .............................................................................................................44
4.2.7 Continuous airway pressure alarm ...................................................................................44
4.2.8 Apnea alarm .........................................................................................................................45

CHAPTER 5 OPERATIONS AND SETTINGS..................................................................................46

5.1 TOUCH KEY ..............................................................................................................................46


5.2 START-UP .................................................................................................................................46
5.3 STANDBY..................................................................................................................................47
5.4 PATIENT SETTINGS....................................................................................................................47
5.5 VENTILATION MODE SETTINGS .................................................................................................49
5.6 ALARM SETTINGS .....................................................................................................................49
5.7 SYSTEM SETTINGS ....................................................................................................................50
5.8 SYSTEM SHUT OFF ....................................................................................................................53

CHAPTER 6 MAINTENANCE.............................................................................................................54

6.1 MAINTENANCE SCHEDULE........................................................................................................56


6.2 MAINTENANCE OF THE VENTILATOR SURFACE .........................................................................56

VI
6.3 MAINTENANCE OF THE FAN FILTER ..........................................................................................57
6.4 MAINTENANCE OF THE AIR WATER FILTER ...............................................................................57
6.5 MAINTENANCE OF THE EXPIRATORY VALVE .............................................................................57
6.6 MAINTENANCE OF THE BREATHING TUBE .................................................................................58
6.7 MAINTENANCE OF THE BATTERY ..............................................................................................58
6.8 MAINTENANCE OF THE OXYGEN BATTERY................................................................................58

CHAPTER 7 CONFIGURATION LIST ...............................................................................................60

APPENDIX A WORKING PRINCIPLE ..............................................................................................61

A.1 GAS PIPELINE SYSTEM ..............................................................................................................61


A.1.1 Summarize.....................................................................................................................61
A.1.2 Airway schematic..........................................................................................................62
A.1.3 Introduction of the function modules..........................................................................63
A.2 ELECTRICAL SYSTEM STRUCTURE ............................................................................................66
A.2.1 General figure of the electrical system structure .....................................................66
A.2.2 Principle summarize.....................................................................................................66

APPENDIX B PRODUCT SPECIFICATION.....................................................................................67

B.1 SYSTEM SPECIFICATION ............................................................................................................67


B.2 MAIN TECHNICAL PARAMETERS ...............................................................................................68
B.3 MAIN SETTING PARAMETERS ....................................................................................................68
B.4 MAIN MONITORING PARAMETERS .............................................................................................69
B.5 MAIN ALARM PARAMETERS ......................................................................................................71

APPENDIX C ALARMS .......................................................................................................................73

C.1 HIGH PRIORITY ALARMS ...........................................................................................................73


C.2 MEDIUM PRIORITY ALARMS ......................................................................................................74
C.3 LOW PRIORITY ALARMS ............................................................................................................76

APPENDIX D SYMBOLS AND GLOSSARY....................................................................................77

D.1 GLOSSARY ................................................................................................................................77


D.2 EQUIPMENT SYMBOLS ..............................................................................................................78
D.3 PACKAGE SYMBOLS ..................................................................................................................79

APPENDIX E DEFAULT SETTINGS .................................................................................................80

APPENDIX F REFERENCE ................................................................................................................82

VII
Chapter 1 Safety Information

Chapter 1 Safety Information


The safety information described in this chapter explains unsafe conditions that may occur

if not performed correctly according to the manual. Please review all the warning, caution

and Note prior to operating the ventilator.

This chapter contains important safety information of the ventilator, and some other safety

information throughout each chapter of the manual. Please read and understand all the

safety information before use to avoid security risks.

The importance of the safety requirement has nothing to do with the arrange order.

Warning:
Identify conditions or practices that could result in serious adverse reactions or

potential safety hazards.

Caution:
Identify conditions or practices that could result in damage to the ventilator or

other equipment.

Note:
Identify supplemental information to help you better understand how the

ventilator works.

Page 1 of 82
Chapter 1 Safety Information

1.1 Warnings

Warnings:
 Only personnel trained and authorized by the manufacturer are permitted to operate

the equipment. Operations of the equipment must be strictly according to the user

manual.

 Only those conform to the latest IEC 601-1 standard accessories and auxiliary

equipment can be connected to the ventilator. If peripheral equipment such as

computers、monitors、humidifiers have been connected to the ventilator, the whole

system should meet the IEC 601-1 standard.

 Users have the responsibility to carry out the necessary measure to ensure that the

curing environment is in line with the limited regulation of the IEC 60601-1-2 standard.

Operating the equipment beyond the regular limit may cause damages or security

risks to the system. The Preventive measures may include (but not limited to) the

following aspects:

 More attention should be paid to the relative humidity and conductivity of

clothes to minimize the possibility of the static gathering.

 Avoid using the wireless radiate devices (such as the mobile phone) or high

frequency devices near the ventilator.

 Due to the possible fire or explosion hazard, all the ignition sources must be away

from the ventilator and the oxygen tube. Do not use the oxygen tube which is worn or

affused or contaminated by the flammable liquid (such as grease or oil). In the

environment of high oxygen concentration, textiles, oils and other combustible

material are easy to cause fire. When you detect a burning odor, cut off the oxygen

supply device、the power supply and the spare resource immediately.

 The ventilator is not designed for the MR environment that is suitable for the

Medication reaction (MR) checking. Otherwise the system may lose some functions

and it may cause permanent damage to the ventilator system.

Page 2 of 82
Chapter 1 Safety Information

Warnings:
 This equipment can only be used in the required environment; it cannot be used near

the flammable or explosive resources and cannot be used in the mobile phone,

radioactive rays or the MRI equipment environment.

 Always perform a regular clean and pre-use check before opening the package.

 The power cord should only be connected to a properly grounded AC electrical outlet

to avoid electric shock.

 Operator will have to ensure that the inspiratory and expiratory resistances measured

at the patient connection port during spontaneous breathing and normal operation

shall not exceed 0.6 kPa at 60 l/min for adult use, 30 l/min for pediatric use.

 Please double-check the power cord before connected to the electrical outlet, make

sure it has no damage, scratch or other factors which will lead to the inside conductor

exposed issues.

 When there is any doubt about the integrality of the outside grounded protection or the

grounded protection cord, the equipment must be replaced with: internal power supply

(battery).

 Keep the ventilator upright during use.

 When adding attachments or other components or sub-assemblies to the ventilator

breathing system, the pressure gradient across the ventilator breathing system,

measured with respect to the patient connection port, may increase.

 The ventilator shall not be covered or positioned in such a way that the operation or

performance of the ventilator is adversely affected.

 Once any abnormal event occurs, such as the unfamiliar pop-up windows on the

screen, unfamiliar sounds, alarms from the patient device, or high priority technology

warning occurs, discontinue use of the ventilator and check it at once, replace the

corresponding components as occasion requires

 Set the warning limit to a proper parameter in order to ensure the safety of patient.

 Positive pressure breathing may be accompanied by the following side effects occur:

barotrauma, hypoventilation, hyperventilation or circulatory injury.

Page 3 of 82
Chapter 1 Safety Information

Warnings:
 The maintenance is allowed only in the condition that the equipment is not connected

to the patient.

 All personnel should be aware that Disassembling or clearing certain parts of the

ventilator may cause infection risk.

Page 4 of 82
Chapter 1 Safety Information

1.2 Cautions

Cautions:
 The ventilator must be maintained and checked at regular intervals by professionals

who have received specialized training. Please refer to the chapter7 for the

maintenance time interval information. All service performed on the ventilator should

be recorded in a service log in accordance with the regulations.

 The Company has no responsibility for the safe operation of the ventilator system if

maintenance or repairs are not performed by personnel who are not employed or

authorized by the Company. It is recommended that you should maintain and repair

the equipment in accord with the compact signed by both parties.

 The Company has no responsibility for the safe operation of the ventilator if it is used

in other field described in the user manual.

 The data measured from the signal output port of the ventilator as well as the data

managed by the ancillary equipment cannot be the basic of treatment or diagnosis

decision. Such decisions can only be made by the experienced medical personnel

based on the previous or accepted manner. The Company has no responsibility for the

accuracy of the signal handling if ancillary equipment not provided by the Company is

used in the system.

 If there is difference between the information displayed on the user interface of the

ventilator and the corresponding information displayed on the auxiliary equipment, the

information on the user interface is considered as the main reason. It is the user’s

responsibility for the integrity and security of the system while using the accessories or

ancillary equipment not provided by the Company. As for the safety of the electrical

system, only those accorded with the latest GB 9706.1 standard accessories and a

auxiliary equipment could be connected to the signal input and output interface of the

ventilator system.

 Only the accessories, spare parts or auxiliary equipment recommended by the

Company can be used to be connected to the ventilator system. Otherwise it may

Page 5 of 82
Chapter 1 Safety Information

Cautions:
cause damage or security to the system.

 Please refer to the assembling instruction described in the user manual to assemble

the system or the optional accessories.

 When accessories or other components or modules are added to the ventilator

system, the pressure gradient of the breathing system relative to the patient interface

will increase, which is not the Company’s responsibility.

 The supplied gas should not contain water, oil or particles, and the content of these

impurity must be lower the following standard:

Air: H2O<7g/m3;Oil<0.5mg/m3;

Oxygen: H2O<20mg/m3;

 Pressure value is given in cmH2O:

1kPa~10cmH2O;

100kPa=1bar~1atm~1kgf/cm2(kp/cm2)

100kPa~15psi

 As general rule, always be careful not to touch the pins of the external electric

connector.

 The measuring value condition shown in this user manual is Ambient temperature and

pressure、dry gas (ATPD) condition.

 Sharp tools should be away form the screen.

 Accumulation of excess liquid in the expiration sensor is not allowed (such as in clean

and disinfection period, otherwise it may affect the function of the ventilator.

 When lifting or moving the ventilator system or some parts of the system, please

comply with the instruction of the machine and do some preparation of the safety.

 Please do not use the soft tube with the characteristic of antistatic electricity or the

electricity conducting.

 The ventilator contains no latex element.

Page 6 of 82
Chapter 1 Safety Information

Cautions:
 Make sure a resuscitator is always available.

 It is recommended that there is at least one battery as backup power supply.

 Once the system connected to the patient, make sure there should always be

someone professional to monitor the system operation.

 Do not disassemble the expiration module during operating the ventilator.

 Use the Heat and Moisture Exchanger (HME) or other effective equipments so as to

prevent the dehydration in the lung system.

 Type I: Special waste: Make sure to discard worn-out batteries and other disposable

parts according to local regulations and in an environmentally acceptable way.

Recycling facilities may not be available in all areas.

 Type II: Special waste: Make sure to discard worn-out O2 sensor according to local

regulations and in an environmentally acceptable way. Can not be discarded in a

normal way.

 The equipment may contain some hazardous waste (infectious) which should not be

discarded in a normal way, please deal with them according to the local regulations.

 All the disposable components should be disposed according to the hospital

regulations and in an environmental safe way.

Note :
 When the pneumatic circuit pressure exceeds 125cmH2O, the safe valve will turn on

automatically to release pressure.

Page 7 of 82
Chapter 2 Equipment Description

2.1 Brief Introduction

This product is a pneumatic electronically controlled ventilator. Users can use the touch

screen, keys and the navigation wheel to operate the equipment conveniently and easily.

According to the user’s setting, the ventilator provides air with the preset oxygen

concentration to patients with continuous flow or continuous pressure to control the patient

or support ventilation; doctors can control the patient timely by real-time monitoring the

respiratory parameters of the ventilator to ensure patient’s safety as well as provide good

treatment.

The ventilator system is intended for treating and monitoring patients with respiratory

failure or respiratory insufficiency. The ventilator should be used only in hospitals or in

facilities whose purpose is to provide health care or during transport of a patient within or

between hospitals or health care facilities.

Contraindications

1) Gas gathering of the pneumothorax and mediastinum diaphragm.

2) A large pleural effusion.

3) Bulla.

4) Hypoxemia.

5) Acute myocardial infarction associated with heart dysfunction.

Caution:
 The ventilator can only be operated by professional medical personnel with

experiences in respiratory disease treatment. Personnel not be trained or authorized

cannot operate the ventilator.

Page 8 of 82
2.2 System Overview

Caution:
 The illustrations in this section are for reference only, due to different configuration,

illustrations may not be completely consistent to the product.

2.2.1 External pipeline connection diagram

1.Trolley 2. Humidifier 3.Expiratiory inlet

4. Patient device 5.Patient system 6. User screen

7.Air and oxygen supply 8. Inspiratory outlet 9. Mains power

10. Mechanical arm 11. Basket 12. Nebulizer interface

Page 9 of 82
2.2.2 User screen diagram

6 Alarm
Silence

5 Alarm
Silence Alarm
Reset

4 Alarm
Reset Lock

3 Lock
Start/
Standby

2 Start/
Standby
11
POWER

POWER

10
9 12

8 7

1. Battery indicator 2. Start/Standby button 3.Lock/unlock button

4. Alarm reset button 5.Alarm silence button 6. Alarm indicator

7. Unlock label 8. Expiratory heating label 9. Expiratory label

10. Inspiratory label 11. Navigation wheel 12. Nebulizer interface

Page 10 of 82
2.2.3 Ventilator rear view

1、System switch label 2、No obstruct label 3、Battery label

4、Power input label 5、Wire pole 6、O2 inlet label

(280~600kPa)

7、O2 inlet 8、Air inlet 9、Cable reel

10、Air inlet label 11、PS2 interface 12、Network interface

(280~600kPa)

13、RS232 interface 14、 VGA/OUT interface

Page 11 of 82
2.2.4 Side view diagram

Oxygen battery label

2.3 Power supply

1. Power supply specification: 100~240 VAC,50/60Hz,1.5A (Max.);

2. Fuse gear specification:T2AL/250V;

3. When connected to AC power supply, the AC indicator light turns on, when

disconnected to AC power, the AC indicator light turns off.

2.4 Battery

Batteries can be used as backup power supply in ICU or during transporting patients. The

ventilator is equipped with one battery module. It is recommended that there is always a

battery module as backup power supply.

The backup battery of the ventilator is one 18.5 V rechargeable lithium battery. When the

ventilator is connected to the main power supply and turned on, the inserted battery

models will be charged. When the power supply is cut off, the ventilator will switch to the

battery power supply automatically, simultaneously, it will emit an AC power supply failure

alarm to prompt users, and will not lead to interruption of the ventilator work.

When operating form batteries, the status of the battery modules is continuously

monitored by the ventilator. If the battery status is unsatisfactory, the ventilator will give

Page 12 of 82
alarms “Low battery capacity” or “No battery capacity” to notify users.

- When “low battery capacity” alarm appears, the remaining time is about 10 minutes

- When “No battery capacity” alarm appears, the remaining time is about 5 minutes.

The battery module can provide about 40 minutes. New battery model should be charged

for more than 10 hours for the first time, and about 5 hours in the future.

Battery specification: Voltage:18.5V,Capacity:4000mAh.

Cautions:
 The exhausted batteries should be disposed according to the local regulations, and

cannot be disposed in a normal way. In some areas, there may be no recycle

facilities.

 Only batteries recommended by the Company can be used in the ventilator.

 The battery life depends on the frequency and time. Using the battery in an improper

way will affect the battery life.

Notes:
 Always remember to charge the battery. When connected to the power supply, the

ventilator will charge the battery modules automatically.

 It is recommended to charge the stored battery models every 6 months.

 If the battery has been discharged and stored for some time, the required charging

time maybe longer than the time listed in the table above.

 Please remove the battery if it will not be used for a long period.

2.5 Gas supply

There are two kinds of gas supply: Air and oxygen(O2). They can be connected to the

Page 13 of 82
central gas supply system, and the required rated pressure range is 0.28~0.6Mpa, there

is a filter and a non-return valve installed in each pipeline of the gas supply, the pressure

is released to the rated pressure range 0.28~0.6Mpa by the pressure regulator.

The ventilator system will monitor the pressure of the gas automatically, when the gas

supply pressure reduces and affects the ventilation, it will give an alarm to notify the users.

2.6 System switch

The ventilator has a specially designed system switch protective shield, which can avoid

touching or impacting the switch accidentally and turn off the ventilator.

2.7 User screen

2.7.1 Start-up screen


The start-up screen is the first screen that can be operated by users when the ventilator is

turned on.

In the start-up screen, users can perform following operations:

- Patient category (previous patient /adult / ped) setting;

- Patient weight modification;

- Ventilation mode modification;

Page 14 of 82
- Startup to enter working mode.

Cautions:
 For more information about above-mentioned operation , please refer to chapter 5

“operation and setting”

 On the start-up screen, the membrane buttons are invalid.

 On the start-up screen, the alarm function is normal if technical alarm occurs.

2.7.2 Standby screen


When the standby mode is selected, the ventilator will enter the standby mode, shown as

below:

2.7.3 Main menu


The main menu displays when the ventilator works, it displays setting parameters,

measured parameters, each type of information and operation function, shown as below:

Page 15 of 82
1. Mode information display area:

1) Display the current ventilation mode;

2) Display the “frozen” membrane button.

2. Alarm information display area:

Display the current alarm information.

3. Status information display area:

1) Display the CPAP icon;

2) Display the current patient category;

3) Display the screen lock icon;

4) Display the battery status;

5) Display the alarm silence icon.

4. Membrane buttons area:

There are 5 membrane buttons:

1) Modes settings;

2) Measured value;

3) Alarm view;

4) System Setting;

Page 16 of 82
5) System log.

Different membrane buttons can adjust different function screens, please refer to

2.7.5 function screen.

5. System time display area:

Display the system date and time.

6. Waveform area:

According to different configuration of models and different settings by users, it will

display the waveform and loop graph of the current patient.

7. Measured parameter area;

Display the measured parameter of the current patient.

8. Modes settings area:

Except using function button 【Modes settings】, users can set the relative ventilation

parameter of the current ventilation mode in the main menu directly, the gray touch

key means the parameter is not available in the current ventilation mode and cannot

be adjusted.

2.7.4 Function screen


The function screen is the screen when the membrane button is pushed; it contains the

detailed settings and operation of certain functions. The function screens are described as

below:

2.7.4.1 Modes settings


The modes Settings screen is as below:

Page 17 of 82
In the Modes setting screen, users can perform following operations:

- Ventilator mode setting;

- Relative parameters in each ventilator mode;

- Other settings;

- Backup ventilation setting;

Note:
 The design of the ventilator makes the parameter settings correspond with the

current ventilation mode, in other words, when you select a ventilation mode, the

screen will only display the parameters related to the current ventilation mode.

2.7.4.2 Measured Values


The measured values screen is shown as below:

Page 18 of 82
The measured value screen mainly displays the current ventilation mode and the related

setting parameters and measured value information.

2.7.4.3 Alarm setting


The alarm setting screen is shown as below:

The current measured value is between the upper limit and the lower limit of the alarm

value.

2.7.4.4 System settings


The system settings screen is shown as below:

Page 19 of 82
In the system setting screen, users can perform following operations:

- Setting the system date and time;

- Setting the alarm volume;

- Setting the system language;

- Setting the other settings;

- Setting the waveform configuration;

- View the version information;

- Access the super mode;

- Enable/Disable Demo;

- The engineer mode is non-user function, and it is used by trained engineers of the

Company to calibrate, upgrade and some other technical operations.

2.7.4.5 System log


The system log screen is shown as below:

Page 20 of 82
There is no user action in the system log screen. It mainly displays the operation

information that the user have performed and the alarm information during operation.

Push the 【page up】or【page down】touch button to view more content.

Note:
 The ventilator can save up to 100 logs for your view.

2.8 Ventilation modes

The ventilator offers varieties of ventilation modes and auxiliary modes, it furthest covers

the most patients’ demand, and brings you great convenience.

2.8.1 VCV mode


VCV (Volume control ventilation) mode. In VCV mode, during the breathing period, the

ventilator provides the mandatory ventilation for the patients with constant flow rate and

pre-set tidal volume. At the same time, in expiration phase, it monitors the pressure status

or the airflow rate in the airway (Pressure trigger or Flow trigger), when the trigger

conditions meet, it will provide the patient with a mandatory ventilation at the same

parameters.

Page 21 of 82
In VCV mode, you can set the breathing hold time (Tp) to improve the gas distribution

conditions in the patient’s lung, and set PEEP to improve the vent of CO2 in end-expiration

and increase oxygen in the breathing process.

In VCV mode, following parameters need to be set:

- 【VT】;

- 【F】;

- 【TI】;

- 【TP】;

- 【FiO2】;

- 【PEEP】;

- 【PTRIG/FTRIG】。

2.8.2 PCV mode


PCV (pressure control ventilation) mode, in PCV mode, during inspiration period, it

provides the mandatory ventilation according to the pre-set pressure for the patient,

during the whole inspiration period, the airway pressure is stabilized at the set value, and

the flow curve is in downward trend. The same with the VCV mode, in the PCV mode, the

mandatory ventilation can be achieved by patient’s triggering in the expiration period.

In PCV mode, you can also set the PEEP value.

In PCV mode, following parameters need to be set:

- 【Pinsp】;

- 【f】;

- 【TI】;

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- 【FiO2】;

- 【PEEP】;

- 【PTRIG / FTRIG】;

- 【Prate】

2.8.3 PSV mode


PSV (pressure support ventilation) mode, in PSV mode, when the patient is activated

spontaneously, the ventilator will support the patient’s inspiration with the pre-set stable

pressure, the flow curve is in downward trend. The end of the patient’s inspiration can be

changed by adjusting the sensitivity.

PSV mode is combined with SIMV mode.

In PSV mode, the following parameters need to be set:

- 【PSUPP】

2.8.4 SIMV mode


SIMV (synchronized intermittent mandatory ventilation) mode. In SIMV mode, the

independent breathing frequency and tidal volume (or inspiratory pressure) is controlled

by the patient, and a synchronous control is active at a certain interval of time; if the trigger

level is met in the waiting trigger window, the ventilator will provide a synchronized volume

(or pressure) control ventilation for the patient; if the trigger level is not achieved in the

trigger window, at the end of the trigger window, the ventilator will give a volume (or

pressure) control ventilation.

SIMV mode includes two modes: SIMV+VCV and SIMV+PCV mode, different modes

decide whether the volume or the pressure control mode will be selected.

SIMV mode is combined with PSV mode, and forms SIMV+VCV+PSV mode and

SIMV+PCV+PSV mode.

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In SIMV mode, following parameters need to be set:

- 【VT】or【PINSP】;

- 【F】;

- 【TI】;

- 【FiO2】;

- 【PEEP】;

- 【-PTRIG/ FTRIG】;

- 【Psupp】;

- 【Tapnea】

2.8.5 DualPAP mode


DualPAP (Dual Positive Airway Pressure) or Dual CPAP ventilation mode. The ventilator

forms the high pressure level and low pressure level according to the pre-set value, and

switches by the pre-set frequency and inspiratory time; patients can breathe

spontaneously at the high pressure and low pressure level by triggering, and the ventilator

is to provide support according to the pre-set pressure.

In DualPAP mode, following parameters need to be set:

- 【TI】;

- 【f】;

- 【ETS】;

- 【FiO2】;

- 【Phigh】;

- 【Plow】;

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- 【Psupp】;

- 【PTRIG / FTRIG】

2.8.6 SPONT mode


SPONT, (spontaneous ventilation) mode. In SPONT mode, patients will control the

breathing rhythm themselves, when the triggered level is met, the ventilator will support

with the pre-set inspiratory pressure; keep the pressure till the inspiratory flow decreased

to the pre-set value and then enter the expiratory phase.

In SPONT mode, following parameters need to be set:

- 【FiO2】;

- 【ETS】;

- 【PEEP】;

- 【Psupp】;

- 【PTRIG/FTRIG】;

- 【Tapnea】

Users can set the backup ventilation in the SPONT mode, providing the mandatory

ventilation when the patient is asphyxial. Please refer to 2.9.1backup ventilation for more

information.

2.8.7 NPPV mode


NPPV (Noninvasive positive pressure ventilation). In NPPV mode, ventilator supplies

assistant ventilation for patients through non-invasive manner such as masks.

In NPPV mode, the following parameters need to be set:

- 【PEEP】;

- 【ETS】;

- 【FiO2】;

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- 【Tapnea】;

- 【Psupp】;

- 【PTRIG / FTRIG】;

- 【Prate】;

2.8.8 PRVC mode


PRVC (Pressure Regulated Volume Control), it has the characteristics of pressure control

ventilation (PCV) mode and volume control ventilation (VCV) mode. In PRVC mode,

inspiration is completed with the preset tidal volume and frequency (times/min) within the

preset inspiratory time, each inspiration is automatically adapt to the controlled inspiratory

pressure, which changes the characteristic of lung/thoracic to ensure commonly using of

the minimum pressure to deliver the preset tidal volume and minute ventilation volume.

The inspiratory pressure keeps constant throughout the preset inspiratory time. The

inspiratory flow rate is decreasing.

In PRVC mode, the following parameters need to be set:

- 【TI】;

- 【f】;

- 【FiO2】;

- 【VT】;

- 【PEEP】;

- 【PTRIG / FTRIG】;

- 【Plimit】;

- 【Prate】;

2.8.9 Standby mode


User can select the standby mode if need, in the standby mode, the ventilator will not

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supply the mechanical ventilation and parameter monitoring functions.

2.9 Special function

Except the common ventilation modes, the ventilator also offers certain assistant

ventilation functions, shown as follows:

2.9.1 Backup ventilation


In SPONT/CPAP mode, when the no-breathing time of the patient reaches the pre-set

value(enabled by suffocation alarm limit), the ventilator will provide the mandatory

ventilation according to the per-set backup ventilation mode and relative parameters for

the patient.

The optional backup ventilation mode and relative parameters are as below:

- VCV mode:【VT】,【f】,【TI】;

- PCV mode:【Pinsp】,【f】,【TI】.

2.10 Alarm system

2.10.1 General description


The ventilator is designed with a perfect alarm system to help insure patient safety. The

ventilator can signal 3 types of alarms according to different potential risks during the

alarm active: High Priority, Medium Priority and Low Priority.

When alarm occurs, it will remind the user by the alarm indicator light, alarm sound and

alarm messages, different types of alarms have different alarm information.

The alarm signals and conditions are grouped into physiological alarm conditions and

technical alarm conditions.

1) Physiological alarms: the monitored gas parameters or the patient physiological

parameters exceed the specified range.

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2) Technical alarms: Due to the improper operations or the malfunctions of the technical

or the equipment, the machine cannot monitor exactly.

According to the different risks when alarm active, the alarms are grouped into: High

Priority, Medium Priority and Low Priority alarm.

1) High priority: when the high priority alarm occurs, it may endanger the patient’s safety

or the equipment cannot work normally, users must stop operating to dealing with the

malfunction.

2) Medium Priority: when the medium priority alarm occurs, it may endanger the

patient’s safety if lasting a long time, or some reasonable settings, users should

adjust the parameters to clear the malfunction.

3) Low priority: when the low priority alarm occurs, it will not endanger the patient’s

safety, there may be some reasonable settings or some unimportant malfunction,

users could adjust the setting parameters properly or clear up the malfunction when

complete operating the equipment.

When alarm occurs, the ventilator will remind users by the following auditory and

visual signals.

1) High priority:

- Alarm indicator light::red flashes;

- Alarm sound:du- du - du -- du - du ---- du - du - du - du - du;

- Alarm message:red background , and displays “!!


!”behind the alarm message;

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2) Medium priority:

- Alarm indicator light::yellow flashes;

- Alarm sound:du - du - du ----- du - du - du;

- Alarm message:yellow background , and displays “!!”behind the alarm

message;

3) Low priority:

- Alarm indicator light::yellow, static, not flashes

- Alarm sound:du-----du;

- Alarm message:yellow background , and displays “!”behind the alarm message;

Cautions:
 When different priorities of alarms occur simultaneously, only the alarm with highest

priority will display.

 When several alarms with the same priority occur simultaneously, the alarm

information area will display the current alarm messages alternately.

2.10.2 Alarm limit setting

Refer to 5.6 alarm setting. push【Alarm view】touch pad to enter the alarm setting screen

and set the alarm limit value.

Caution:
 Please always pay attention to the alarm limit parameter and make sure it is set at a

proper and reasonable level to avoid inaccurate alarms.

2.10.3 Alarm silence

When alarm occurs, push 【Alarm silence】membrane button, the alarm sound will be

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muted, meanwhile, the alarm silence icon and alarm silence 100 seconds count

down will display on the top right area of the screen.

The alarm silence status lasts for 100 seconds, 100 seconds later, and the alarm silence

will be disabled and the alarm sound resumes.

In the alarm silence status, push【Alarm silence】membrane button again to resume the

alarm sound.

Cautions:
 In alarm silence status, except for the alarm sound, the other alarm functions are

working normally.

 In alarm silence status, if new alarms occur, the alarm silence will be disabled and

alarm sound will be active according to the latest alarm.

 【Alarm silence】membrane button is invalid if no alarm occurs.

2.10.4 Alarm reset

When alarm occurs, push 【Alarm Reset】 membrane button, all the alarms currently will

be cleared , the alarm system begins monitoring again.

【Alarm Reset】membrane button is invalid if no alarm occurs.

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Chapter 3 Disassembling and
assembling

3.1 Trolley

1、 Assembling:

1 8

2
7

3 6

5
Assembling process :

1) Put the pole into the bottom of the trolley, and use the prepared 6 M5 hexagon screws

⑤ to lock the pole to the bottom of the trolley.

2) Put the trolley platform to the top of the pole, aim at the screw and lock the 6 M5

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hexagon screws⑧ (Note that when installing the trolley platform, the 4 countersunk

head holes must be upturned, these holes are fixed holes of the host).

3) Use the M4 cross screw⑦ to fix the humidifier shelf ② basket⑥ to the fixed screw

at the mid of the pole, and lock the screws on both sides.

2. Disassembling:

1) Use a cross screwdriver to demount the screws that fixed the humidifier shelf and

basket, then disassembly the humidifier shelf and basket.

2) Use a hexagonal wrench to demount the 12 hexagonal screws, then disassembly the

pole, trolley base and the trolley platform.

3.2 Ventilator system

1. Assembling:

4
7

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Assembling process:

1) Lock the wheels of the trolley⑥, put the four pads that are under the bottom of

the host in a right position according to the fixed holes of the trolley platform,

make sure all the four pads had been put to the countersunk head holes. Use the

prepared screws to lock the host from upward the bottom of the trolley platform.

2) Install the mechanical arm: insert the mechanical arm ① to the mechanical arm

holder on the side of the host, and lock the mechanical arm screws⑦;

3) Install the humidifier: insert the humidifier to the shelf on the middle of the pole.

2. Disassembling:

1) Screw reversely to loose the screws and then disassembly the mechanical arm;

screw to loose the fixed screw⑦ to disassembly the mechanical arm and the fixed

block.

2) Loose the host fixed screw④ to disassembly the trolley and the host.

3) The humidifier can be pulled out and inserted directly.

3.3 Battery modules

1. Assembling:

Assembling process:

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1) As the diagram shown above, remove the battery cover; push the battery module into

the socket completely.

2) Install the battery cover, tighten the screws.

2. Disassembling:

Remove the battery cover, push up the pin, pull the active tape to remove the battery

module.

3.4 Oxygen battery

1. Assembling:

Assembling process:

1) Remove the M2 cross countersunk head screws on the battery cover.

2) Tighten the new oxygen battery clockwise, and then plug the oxygen sensor wire

from the oxygen battery.

3) Close the battery cover and tighten the screws after battery replacement.

2. Disassembling:

1) Push the power switch on the rear side of the host to “off” and shut down the ventilator

system.

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2) Disconnect the ventilator from main power supply and gas supply device.

3) Demount the M2 cross countersunk head screws on the oxygen battery cover and

remove the battery cover.

4) Pull out the sensor connection wire, and then twist the oxygen battery anticlockwise to

take off the oxygen battery.

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3.5 Patient system

1. Assembling:

1、Patient’s pipeline 2、Humidifier

3、Vaporizer 4、Y piece

Please connect the patient system as the diagram shown above.

2. Disassembling:

Take down the inspiratory tube and the expiratory tube separately from the inspiratory

port and the expiratory port of the host.

Cautions:
 When disassembling the respiratory pipeline, make sure the humidifier has been

shutoff and disconnected to the power supply.

 When disassembling the respiratory pipeline, please hold the tie-in on the two ends of

the whorl tube to avoid damages to the whorl tube and the inspiratory/expiratory

connection port.

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3.6 Expiratory valve

1. Assembling:

Assembling process:

1) During the installation of the valve, firstly put the membrane into the socket, and

then align the three-way pipe of the expiratory valve to the corresponding socket

of the front panel and push the three-way tube to fasten it, lastly, rotate clockwise

the expiratory valve adapter. Pay attention to the position of the membrane and

the sampling outlet to avoid leakage.

2) Check the position of the expiratory valve adapter.

2. Disassembling:

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During disassembling, turn anticlockwise the expiratory valve adapter; pull out the

three-way pipe by your both hands simultaneously.

3.7 Power supply outlet

Caution:
 Please use the protective grounded power outlet, otherwise it will lead to increase of

leakage current and result in risk.

3.8 Connecting the gas supply

1. Assembling:

Use a monkey wrench or special wrench to fasten the oxygen inlet connection tube and

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the air inlet connection tube.

2. Disassembling:

Cut off the air and oxygen supply, use a monkey wrench or special wrench to demount the

oxygen inlet connection tube and the air inlet connection tube.

3.9 Humidifier

1. Assembling:

Cautions:
 The humidifier must be connected to the protected grounded power jack, and the

grounding should comply with the national regulations.

 The humidifier should not be used in flammable or explosive environment. Should

only be operated by trained medical personnel.

 When the equipment is out of work, do not assemble or disassemble it, please

contact the authorized personnel for repairs.

The humidifier connection diagram is shown as below:

Preparations before start-up:

1) Fasten the humidifier by the bracket of the ventilator, pay attention that the location of

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the humidifier must be lower than the patient;

2) Put the humidifier water container on the front block-ring, push down the front

block-ring and slide backwards to the heated plate, when it is in place, the heated

plate under the humidifier water container is close to the heating plate and locked

automatically, the front block-ring automatically bounces.

3) Inject water in-between the maximum and minimum water level.

4) According to the direction of the arrow on the humidifier water container, plug the

airway adapter to the gas entrance of the humidifier water container.

5) Connect the gas inlet and outlet pipeline of the humidifier.

Warnings:
 Use only the suitable humidifier water container.

 When adding water, the water should not be higher than the maximum water level, or

else it may spill to the respiratory pipeline, and not be lower than the minimum water

level.

 Do not add water that is more than 37℃ to the humidifier water container.

 Arrange the respiratory pipeline to ensure it can get water and discharge at any time.

 Water quality requirement: should use distilled water; otherwise, it will affect the life of

the device.

 When the temperature inside the heating plate reaches to 92±5℃, the over heated

protective relay will disconnect the humidifier power supply, the power indicator light

turns off, when it is cooling, the over heated protective relay will reset automatically

and connected to the power supply, the power indicator light turns on.

 The over heated protective phenomenon only appears when the humidifier is

abnormal (including out of order or damaged). When this happens, please contact the

local suppliers or the service department of the Company.

2. Disassembling:

1) Disassembling the humidifier water container

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① Close the humidifier, pull out the gas pipeline connected to the humidifier.

② Push down the front block-ring, slide forward the humidifier water container to

disassemble the humidifier water container from the humidifier.

2) Disassembling the humidifier cup

①Hold tightly the heated plate and the humidifier cup separately by your hands and

detach them forcibly; Or use a small screwdriver to unclench the humidifier cup slightly

along the edge of the heated plate and make them separate.

②After cleaning and drying, put away the inner canister, push down the humidifier cup till

the heated plate is in place.

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Chapter 4 Pre-use check

4.1 System checking

Before using this equipment, please read the user manual and understand the operation

and maintenance of each part of the equipment, and make sure it meets following

requirements.

1. The equipment is in good condition with no damage.

2. All the components are connected accurately.

3. The respiratory system is connected accurately with no damage.

4. The gas supply system is connected accurately and the pressure is normal.

5. All emergency equipments are in ready and in good condition.

6. All equipments that used for the maintenance of the pipeline and the intubations of

the windpipe are available and in good condition.

7. Make sure there is no loose phenomenon on the truckle and the brake has been

locked and the ventilator cannot be moved.

8. Connect the power cord to the AC power outlet, switch on the AC power supply, the

AC power indicator and the battery indicator will light, if not, that means the system

has no electricity.

Warnings:
 Please always do a pre-use check before the patient is connected to the ventilator.

 Please connect the power cord to a protective grounded power outlet in order to

avoid electric shock.

 If any functional failures detected, and failures persist, the ventilator cannot be

connected to the patient.

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4.2 Alarm test

4.2.1 Preparations before alarm test


1) Connect the test lung to the patient port of the Y-piece.

2) Switch on the system.

3) Set parameters as below:


 Patient type: Adult;

 Ventilation mode: VCV;

 VTE: 500 mL;

 f: 12bpm;

 TI:1.0s;

 FiO2:40%;

 PEEP:0.

4.2.2 High airway pressure alarm

1) Push【Alarm View】touch key to enter the alarm setting screen.

2) In【Alarm View】screen, set the upper limit of PAW less than or equal to the measuring

value.

3) Make sure the【Airway pressure high!!!】alarm displays on the screen.

4) Set the upper limit of PAW more than the measuring value.

5) Make sure the【Airway pressure high!!!】alarm disappears.

4.2.3 Low volume alarm

1) Push【Alarm View】touch key to enter the alarm setting screen.

2) In【Alarm View】screen, set the lower limit of VTE more than or equal to the measuring

value.

3) Make sure the 【Tidal Volume Low!!】alarm displays on the screen.

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4) Set the lower limit of VTE less than the measuring value.

5) Make sure the 【Tidal Volume Low!!】alarm disappears.

4.2.4 Low oxygen concentration alarm

1) Push【Alarm View】touch key to enter the alarm setting screen.

2) In 【Alarm View】screen, set the lower limit of FiO2 more than or equal to the

measuring value.

3) Make sure the 【O2 Concentration Low!!!】alarm displays on the screen.

4) Set the lower limit of FiO2 less than the measuring value.

5) Make sure the 【O2 Concentration Low!!!】 alarm disappears.

4.2.5 Pipeline failure alarm


1) Pull out the patient’s breathing pipeline.

2) Make sure the 【The pipe is failed!!!】alarm displays on the screen.

3) Connect the patient’s breathing pipeline again.

4) Make sure the 【The pipe is failed!!!】alarm disappears.

4.2.6 Power failure alarm


1) Disconnect the power supply when the ventilator is equipped with battery.

2) Make sure the 【Power failure!!!】alarm displays on the screen.

3) Connect the ventilator to the Power supply again.

4) Make sure the 【Power failure!!!】alarm disappears.

4.2.7 Continuous airway pressure alarm

1) In the inspiratory phase, push【Insp Hold】membrane button.

2) About 15 seconds later, make sure the 【Continuous airway pressure high!!!】alarm

displays on the screen.

3) Press【Insp Hold】membrane button again.

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4) Make sure the 【Continuous airway pressure high!!
!】alarm disappears.

4.2.8 Apnea alarm

1) Push【Modes Setting】touch key.

2) Set the ventilation mode to【SPONT】, do not press the test lung.

3) Make sure the 【Apnea!!!】alarm displays on the screen within the set apnea time.

4) Press the test lung several times, make sure the 【Apnea!!!
】alarm appears.

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Chapter 5 Operations and settings
5.1 Touch key

Different color of touch keys shows the ventilator in different status:

- The blue key pad indicates the normal status; you can press it to operate. For example:

- The light blue frame indicates the active status: the key is selected, and can be operated

directly. For example:

- The gray key pad indicates the unusable status; the parameter cannot be adjusted

currently. For example:

5.2 Start-up

1. Connect the power cable to the power outlet; make sure the power supply works

normally.

2. Turn on the system switch on the rear of the host.

Warnings:
 If abnormal alarms occur when the system starts up, please discontinue operation

and contact with the authorized repair personnel or the after service department of

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the Company.

 Only the specified, protective grounded power supply can be used in this equipment.

5.3 Standby

The user can select standby mode if need, in standby mode, the ventilator will not supply

mechanical ventilation or parameter monitoring functions.

Enter the standby mode:

1) Push【Start/Standby】touch key on the panel..

2) Push the navigation wheel to enter standby mode.

Exit the standby mode:

In standby mode, push the navigation wheel to exit standby mode to the main screen.

5.4 Patient settings

1. The patient category is divided into three types:

- 【Previous Patient】;

- 【Adult】;

- 【Ped】;

Different patient categories decide different parameter setting and operation. In start-up

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mode, user can set or change the patient categories.

Previous Patient:

Every time when the system is shut off, the ventilator will save the current ventilation

mode and relative parameter settings which can be selected by users as a patient type

when the system turns on the next time.

Follow the procedures below to set patient’s category.

1) In start-up mode, push【Previous patient】, 【adult】or 【ped】to select the patient

category.

2) Push the navigation wheel to confirm the selection.

2. Weight setting:

User can set the patient’s weight in Start-up mode. The ventilator calculates the

referenced tidal volume value in the volume ventilation mode according to different weight

of the patient.

For different patient categories, the setting range of the weight is different:

- adult:20-150kg;

- Pediatric:5-20kg;

1) Push the patient’s weight, and the area turns light blue.

2) Adjust the weight value by turning the navigation wheel.

3) Push the navigation wheel to confirm setting.

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3. Modes setting:

1) Push the modes settings touch button.

2) Select a mode in the drop-down menu.

5.5 Ventilation mode settings

1. Mode and parameters setting

1) In ventilation status, push the【Mode Setting】touch button.

2) Push the【Mode】 option frame and select the ventilation mode in the drop-down

menu.

3) Push the ventilation parameters that need to set, turn the navigation wheel to adjust

the value and push the navigation wheel to confirm setting.

4) Backup mode can be set in SPONT/NPPV mode. Push the 【Backup Mode】 option

frame and select “VCV” or “PCV” in the drop-down menu.

5.6 Alarm settings

Users can use the alarm setting function to adjust the alarm parameters for the needs of

monitoring and protecting the patients.

Please refer to the Appendix B.5 for more information about the alarm parameter and

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setting range of this ventilator.

Please refer to the Appendix E for the information about the system default alarm setting

of this ventilator.

1. Push the upper limit or the lower limit parameter value, and the frame turns yellow.

2. Turning the navigation wheel to adjust the value.

3. Push the navigation wheel to confirm your settings.

4. Push【default】touch key, all the parameter value will resume to the system default

value.

5.7 System settings

1. Common settings

Users can set the date/time, alarm volume and language of the system.

1) Push the parameter value that you desire to set, the frame turns yellow.

2) Turning the navigation wheel to adjust the value and push the navigation wheel

to confirm your settings.

2. View settings

Users can configure the waveform displayed on the screen; the system can display three

waveforms simultaneously.

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1) The first wave options:

- Pressure-Time;

- Flow-Time;

- Volume-Time;

2) The second wave options:

- Pressure-Time;

- Flow-Time;

- Volume-Time;

3) The third wave options:

- Pressure-Time;

- Flow-Time;

- Volume-Time;

4)The display font options:

- Waveform1;

- Waveform2;

- Waveform + Loop;

- Trend;

- Big font;

If you select 【 wave 】, the screen will only display the waveform, if you select

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【wave+Loop】, the Loop will display on the right side of the screen, the Loop contains the

following types:

- Pressure-Volume

- Pressure-Flow

-Flow-Volume

3. Other settings

Push the 【Other settings】touch button to access the other settings screen, shown as

below.

1) Atomize

Push the option frame and select “Disable”, “10 minutes”, “20 minutes” or “30

minutes” in the drop-down menu.

2) Trigger selection

Push the 【 Trigger Type 】 option frame and select “Flow Trigger

(0.5~10LPM/0.5~20LPM) ”or “Pressure Trigger” in the drop-down menu.

3) Waveform selection

Wave type can be set in VCV and SIMV+VCV mode. Push the【Wave Type】option frame

and select “Square” or “Degressive” in the drop-down menu.

4) Sigh

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Push the option frame and select “Disable” or “Enable” sigh.

5) Close the mode setting screen

Push 【Exit】touch button to exit the mode setting screen.

3. Version information

Push【Version Info】to view the current version information.

4. DEMO

Push 【Enable Demo】touch button to enter demo mode, push this button again to disable

demo mode.

5. Super mode

Super mode is mainly used by trained engineers of the Company to calibrate or upgrade

the system.

5.8 System shut off

When finish using the system, please shut off of the system as following procedures:

1. Disconnect the pipeline that connected to the patient;

2. Turn off the switch on the rear of the host;

3. Shut off the AC power supply;

4. Clean the surface of the equipment if need.

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Chapter 6 Maintenance

Warning:
 Everyone should realize that some parts of the ventilator may be in danger of

infection when dismantled and cleaned.

Cautions:
 Some parts of this equipment can not be disposed in a normal way.

 All the disposable parts should be disposed in a safe and environmental way

according to the hospital regulations.

 After every disassembled cleaning or reinstallation, it can be used regularly only after

the pre-use checking in chapter 4.

 In order to prevent damages, if you have any problems about the cleanser, please

see the data provided by the manufacturer.

 Do not use organic cleanser, halogenations or organic solvent, anesthetic, glass

cleanser, acetone or any other irritant cleanser.

 Do not use abrasive cleanser. (such assteel wool, silver polish or detergent)

 Place the liquids far away from the electronic components.

 Do not use equipment which is out of order. Please let authorized customer service

representative of the Company complete all the necessary maintenance work

whenever at possible or accomplish the maintenance work of listed parts in the user

manual by some qualified and experienced staff.

 Use parts produced or sold by the Company to replace those broken ones, and have

a test after replacement to assure that they correspond with the specification

requirements of the manufacturer.

 If you need service support, please contact with after-sale service department of the

Company.

 When taking any parts from the ventilator, you should abide by the hospital rules and

Page 54 of 82
regulations about taking and disposing infectiousness materials. Because the way of

cleaning, sterilizing in the Medical institutions is very different from the practice.

Therefore the Company can not satisfy all the special needs and can not be

responsible for cleaning, sterilizing or other hygienic measure taken by the hospital

during therapeutic process. We suggest that you use the effective methods already

proven in this user manual, specific equipment and steps. Other methods may be just

as effectively, but we do not guaranteed unless the Company provides written

authorization.

 We suggest that when cleaning or sterilizing, you should use drinking water at least

or more healthful water, otherwise, the result may be affected.

 Cleaning is the most important step in cleaning and sterilizing process. If you clean

the instrument improperly, it would be impossible to sterilize or high temperature

sterilize effectively. Eliminating most of bacterium and filth by cleaning is significant

guarantee for achieving the best sterilization.

 The instrument should be cleaned and sterilized immediately after using if possible.

Filth like saliva or blood should not remain in the instrument and turn dry.

Page 55 of 82
6.1 Maintenance schedule
Maintenance
Maintenance
Frequency

Every patient respiratory valve, reusable breathing tube

Every day ventilator surface

Every half year Fan filter, air water filter, battery

Every year Oxygen battery

When cleaning
Check the parts good or not, change or repair it if necessary
and installation
Perform based on
Respiratory valve, reusable breathing tube, humidifier
requirement

6.2 Maintenance of the ventilator surface

1. Using wet clothe that dipped in flexible cleaning fluid (70% of medical alcohol) to wipe

the surface of the ventilator.

2. After finish the clean of the surface, using dry, Lint-free clothe to wipe the residual

detergent.

Warning:
 If liquid dips into control units , it will damage the equipments or induce people in

danger, please make sure there is no liquid dip into the control units, and must

disconnect the equipment and the AC power during the process of cleaning the

surface. Reconnect the AC power after all the parts that have cleaned are dried.

Cautions:
 The screen must be cleaned by a cloth that is dry, soft and lint-free, do not use

liquid.

 If there is too much dirt on the surface, you can use Ethylene glycol or isopropyl

alcohol.

Page 56 of 82
6.3 Maintenance of the fan filter

Check fan filter periodically to make sure it is clean (the color should be black).if dusty,

you can dismantle the filter remove (embedded button) and rinse it in the water, shake the

filter to remove the additional water drop.

6.4 Maintenance of the air water filter

Cautions:
 Do not block the outfall of the air water filter.

 Replace requirements: 1. Replace the filter module every year 2.Change the filter

module when the pressure difference reaches to 0.1 MPa.

6.5 Maintenance of the expiratory valve

1. Put the three way tube, expiratory valve adapters, diaphragm into disinfectant

chemicals about 30 minutes.

2. Take them out and dip them in clean water for 30 minutes, repeated twice.

Warning:
 Never use high-pressure air or brush to clean the flow sensor.

Page 57 of 82
6.6 Maintenance of the breathing tube

1. Disinfection of the reusable breathing tube

Clean it with Detergent or disinfectant in a heating room (at least 10 minutes, the

recommended temperature inside is 80 degree) or use clean water or mild detergent

(the recommended temperature is 40 degree), and wipe it with the 70% of medical

alcohol; or use the high-temperature, high-pressure steam sterilization (the maximum

temperature is 134 degree).

2. Disinfection of the disposable breathing tube

The disposable breathing tube should be processed in a safe and environmental way

according to the local regulations or the hospital rules.

6.7 Maintenance of the battery

Cautions:
 Only use batteries appointed by the Company.

 In order to extend the battery life, use the battery at least one time every month, and

when the battery is being exhausted, charge it.

 The life of battery depends on the frequency and operation of used, if using it

improperly, the life will be shorter.

 Exhausted batteries must be replaced or discarded according to the local regulations,

and cannot be discarded in a normal way.

6.8 Maintenance of the oxygen battery

Replacement of the oxygen battery:

1) The assembling and disassembling refer to section 3.4 oxygen battery.

2) Open the package of oxygen battery, and put the gasket into the sealing groove of the

battery.

3) Turn the oxygen battery clockwise to the proper position, and plug the cord of the

Page 58 of 82
oxygen sensor.

4) Close the oxygen battery door.

Warnings:
 If any operations will induce danger to the patient, like changing the O2 sensor, then

should disconnect the tube between the ventilator and the patient.

 The exhausted O2 sensor must be replaced or discarded according to the local

regulations, don’t discard the obsolete O2 sensor in a normal way.

 The O2 sensor is a sealed part; it contains corrosive liquid which can burn the skin

and eyes badly. If touches the skin carelessly, you should flush with clean water at

least 15 minutes immediately and go to the hospital, especially when the corrosive

liquid touches eyes.

Page 59 of 82
Chapter 7 Configuration list

Warnings:
 Please use accessories provided by the Company in order to avoid the inaccurate

data or equipment failure.

 Disposable accessories can be used only once, repeated using may lead to

performance degradation or cross-infection.

 If you discover that the accessories package or the accessories are damaged, do not

use the accessories.

Recommended accessories, damageable parts list:

No. Name Specification


1 Mask Adult / Pediatric
Adult
2 Manual bag
Pediatric(optional)
Ventilator disposable
3 Adult / Pediatric
absorber suit
4 Oxygen battery MOX-4

Caution:
 Accessories listed above are recommended by the Company, the Company has no

responsibilities for the result if accessories of other specification are used.

Page 60 of 82
Appendix A Working Principle

A.1 Gas pipeline system

A.1.1 Summarize

This ventilator is pneumatic-controlled. In the designing of the ventilator, we strive for the

high accuracy, high frequency and intelligent. The ventilator will control the value of

oxygen and the air flow according to the preset value, trough the entire airway pipe, the

mechanical ventilation is completed. According to the functions, the ventilator system is

divided into four parts: the inspiratory module, expiratory module, PEEP controlling

module and patient circuit.

1. Inspiratory module

1) The gas supply inlet and controlling module——import gas supply from the

pipeline or cylinder to the ventilator, and provide stable gas flow with the

pressure about 2.5bar.

2) The gas flow controlling module——control the air and oxygen flow separately

through the solenoid proportional valve in order to reach the pre-set ventilation

standard.

3) The gas mixer and safety valve system——make sure that the mixture of the air

and the oxygen is adequate, and deliver it to the patient through the inspiratory

port. At the same time, when the patient’s airway pressure is much higher, the

safety releasing valve immediately opens to release the high pressure gas so as

to protect the patient from being hurt. The spontaneous breathing valve will

ensure that when serious malfunctions occur in the ventilator, the spontaneous

valve opens; therefore the patient can breathe spontaneously from the air.

2. PEEP controlling module

Achieve the PEEP function by electrical-controlling to reach the preset PEEP

Page 61 of 82
(positive end-expiratory pressure).

3. Expiratory module

To achieve the patient’s expiratory function during mechanical ventilation, and assist

the inspiratory module to realize different modes of mechanical ventilation.

4. Patient system

Connect the ventilator with patient through the patient system, and deliver the

controlling gas to the patient.

The division of the modules is as below:

A.1.2 Airway schematic

Page 62 of 82
A.1.3 Introduction of the function modules

1. Inspiration controlling module

The inspiration controlling module is the initiative part of the ventilator’s air way, whose

main function is to import gases from outside pipeline or high pressure gases from

cylinders to the machine. These gases, through the filter, non-return valve and the

pressure sensor in the pipeline, then the pressure is reduced to stable 250kPa by the

pressure regulator. After that the pressure of the gases (250kPa) can be taken as the

normal pressure for the machine. The corresponding pressure sensor of the pipeline

monitors pressure of the gas supply, if pressure of the gas supply is 280kPa~600kPa, the

ventilator is in normal operation; If pressure is below 280kPa or above 600kPa, the

performance of the ventilator will be affected or even some parts will be damaged. Then,

the ventilator will generate an alarm to prompt users and stop ventilation to ensure the

patient’s safety.

2. Gas supply module

This module is divided into two parts: the air part and the oxygen part. The oxygen part

includes the oxygen connector, filter, non-return valve, pressure sensor of the pipeline,

pressure-reducing valve; due to the fact that there is much water in the air, so the air filter

cup is equipped at the air inlet, in addition, the air part consists of the gas supply

connector, filter, non-return valve, pressure sensor of the pipeline, pressure-reducing

valve.

3. Gas flow controlling module

The main function of this module is to control the air and oxygen flow before they enter in

to the mixer so as to reach the preset ventilation target. The pressure regulating valve

outputs air and oxygen with stable pressure, after being controlled by the solenoid

proportional valve, the gases will be measured by the flow sensor.

Page 63 of 82
4. Gas mixer and safety valve system

The gas mixer will mix air and oxygen adequately; it can also buffer the patient’s

inspiration in a much better way other than mix gases.

The spontaneous respiratory valve has two functions:

1) When the ventilator is working normally, the spontaneous respiratory valve is

electriferous; the port of the valve is blocked so the air cannot enter the mixer

module.

2) When fatal malfunctions occur in the ventilator (such as the power supply is

cutoff, the low pressure alarm for the gas supply, the gas supply is cut off), the

spontaneous respiratory valve is cut off and its port will open completely to make

the patient breathe freely.

5. PEEP controlling module

In order to achieve the function of PEEP during the breathing, this ventilator adopts the

electric-controlled electromagnetism valve to make the value of the controlling PEEP

more precise so as to achieve the quick responding.

6. Expiration module

The exhalant air from the patient will be directly connected to the expiration module to

complete the whole process of the breathing. The expiration module consists of the heater,

pressure monitoring, solenoid valve, expiration valve, flow monitoring.

In order to prevent the air exhaled from the patient being condensed or to avoid the

difference in the pressure sensor, the air should be heated at the end of the expiring, the

temperature of the heating is 37 -45 .

The expiring valve has two functions:

1) To achieve the single transportation for the expiring.

2) To achieve the function of the PEEP.

Due to the fact that the expiratory valve is of special material, it will prevent the air

refluencing in the inspiratory phase. Using the large flow monitoring component at the

expiratory port to meet the needs of deep breathing or large volume ventilation.

Page 64 of 82
7. Patient system

Preset the ratio of the mixture between the air and the oxygen, and connect it through

the humidifier and the Y tube with the patient. The patient’s expired air enters into the

expiration part directly through the Y tube.

Page 65 of 82
A.2 Electrical system structure

A.2.1 General figure of the electrical system structure

A.2.2 Principle summarize


1. The hardware of the ventilator mainly consists of the battery module, the upper

computer main unit, the airway controlling unit etc., the diagram is shown as above,

and the main function is described as following:

2. The battery modules, supply power for the boards,valves,sensors,heaters,fans

etc.The input of the battery module is selected in two ways, one is the mains

power(AC 100~240V),the other is from lithium battery;

3. The upper computer main unit, provides running platform for the operation system, it

is the center controlling unit and the executive unit of the complete unit.

4. The airway controlling unit provides drive and control for the valves and sensors,

controlling the pressure and flow of the airway.

5. The display controlling unit, provide the display and user input function, achieve

Human-Computer Interaction.

Page 66 of 82
Appendix B Product specification

B.1 System specification


General
Contents
information
According to the China state food and drug administration classification, this
Category
ventilaor is for ClassIII devices
TYPE:I ,containing the internal power supply
Electric shock When you have doubt about the integrality of the external protective grounded or
defending type the protective grounded cable, the equipment should be replaced by the internal
power supply (batteries)
Electic shock
TYPE:B
defending grade

Pediatric(weight:5 ~20kg)
Suitabel range
Adult(weight:20 ~150kg)

External
Power input: 100~240 VAC,frequency :50/60Hz ,
power
Power supply supply Current input:1.5A (Max.)
Backup
One battery module, Voltage:18.5V,Capacity:4000mAh.
batteries
Pressure
supply 280~600kPa
range
The gas provided should not contain water,oil or impurity particle,
Gas supply and the content must be lower than the following standard.
gas
Air:H2O<7g/m3,Oil<0.5mg/m3;
impurity

Oxygen:H2O<20mg/m3;

Temperature:-10℃~+50℃;

working Humdity:≤95%(non-condensation);
Environment
Atmospheric pressure:700hPa~1060hPa;

storage Temperature:-20℃~+55℃;

Page 67 of 82
Humdity:≤95%;

Atmospheric pressure:500hPa~1060hPa;

trolley Volume:1560×840×730(mm);Weight:18.7kg(net weight)


Complete device
Host etc. Volume:610×610×380(mm);Weight:21.6kg(net weight)

B.2 Main technical parameters


Parameter Description
Category Pneumatic electronically contronlled ventilator

Display 10.1inch,TFT display,touch screen(optional)

Battery Li batteries, power supply for at least 40 minutes.

VCV,PCV,SIMV+VCV,SIMV+PCV,PSV,SPONT,NPPV,PRVC(optional)
Ventilation mode
DualPAP (Not suitable for C series, and optional for D series)
waveform: prssure-time, flow-time,volume-time;
Graphics display
Loop graph(optional):pressure-volume,pressure-flow,flow-volume.
Safey pressure in ≤125cmH2O
the airway system
Data communication RS232 serial port,Ethernet port,VGA interface, debugging interface.
interface

B.3 Main setting parameters


Parameter Description

Range :C series:50~1500 mL;D series:20~2000 mL;

increment:20~100 mL:5 mL;


Tidal volume
100~1000 mL:10 mL;

1000~2000mL:50 mL

Respiration frequency Range:in SIMV mode:1~40 bpm,in other modes: 4~100 bpm;increment:1

bpm
Inspiration time
Range:0.1~10.0 s;increment:0.1 s

Breathing hold time Range:0~4 s;increment:0.1 s

Page 68 of 82
Pressure trigger Range:-20cmH2O~0;increment:1 cmH2O

Flow trigger Range:0.5~20 L/min;increment:0.5 L/min

PEEP Range:0~50 cmH2O;increment:1 cmH2O

Pressure support Range:0~70 cmH2O;increment:1 cmH2O

Pressure control Range:0~70 cmH2O;increment:1 cmH2O

High pressure Range:5~70 cmH2O;increment:1 cmH2O


level(optional)
Not suitable for C series, and optional for D series

Low pressure Range:0~50 cmH2O;increment:1 cmH2O


level(optional)
Not suitable for C series, and optional for D series

Oxygen concentration Range:21~100%;increment:1%

Press this button; the waveform will stop refurblish, press it again to activate or it
Frozen-up(optional)
will be activated automatically after 30 minutes.

B.4 Main monitoring parameters

Parameter Description
Inspiration tidal
Range:0~3000 mL;Resolution:1 mL
volume
Expiration tidal
Range:0~3000 mL;Resolution:1 mL
volume
Minute ventilation
Range:0~99 L;Resolution:0.1 L
volume
Spontaneous minute
Range:0~99 L;Resolution:0.1 L
ventilation volume
Total respiration
Range:0~100bpm;Resolution:1 bpm
frequency
Spontaneous
Range:0~99 bpm;Resolution:1 bpm
respiration requency
Inspiration and
Range:4:1~1:9;Resolution:0.1
expiration rate

PEEP Range:0~50 cmH2O;Resolution:1 cmH2O

Airway peek
Range:0~100 cmH2O;Resolution:1 cmH2O
pressure

Page 69 of 82
Average airway
Range:0~100 cmH2O;Resolution:1 cmH2O
pressure
Inspiration platform
Range:0~100 cmH2O;Resolution:1 cmH2O
pressure
Minimum airway
Range:0~100 cmH2O;Resolution:1 cmH2O
pressure
Oxygen
Range:21~100%;Resolution:1%
concentration

Airway resistance Range:0~200 cmH2O/(L/s);Resolution:1 cmH2O/(L/s)

Compliance Range:0~200 mL/cmH2O;Resolution:1 mL/cmH2O

Page 70 of 82
B.5 Main alarm parameters
Alarm content Range

Adult :OFF,100~2000 mL
Tidal volume low
Pediatric: 30~2000 mL

High 0~40 L
Minute volume
Low OFF,0~39 L

High 21~100%
Oxygen
concentration
Low OFF,21~99%

High 1~100 cmH2O


Airway pressure
Low 1~99cmH2O

High 1~100bpm
Respiration
frequency
Low 0~99 bpm

It will generate an alarm when the airway pressure is continuous above


Continuous airway pressure
high (PEEP+15)cmH2O for 15 seconds

Suffocation alarm
The set time:10~60 s, increment :5 s

Oxygen low alarm The oxygen supply pressue is less than 0.28 MPa
Air low alarm The oxygen supply pressue is less than 0.28 MPa
AC failure alarm The alarm time is more than 120s
Low battery alarm The battery working time is 10 minutes after alarm
Battery exhausted alarm The battery working time is 5 minutes after alarm
Alarm silence count down ≤100 s
Alarm sound >65dB

Page 71 of 82
Page 72 of 82
Appendix C Alarms

C.1 High priority alarms


Alarms content Possible reasons Solutions
Exceed the pre-set value or the
Check the patient and the
alarm limit. The interval time
breathing system.
Suffocation between the two continuous
Check settings of the ventilator.
inspiring tries is above the preset
limit value.
The airway pressure exceeds
the preset upper limits pressure.
Airway pressure high
The pipeline is twisted or
Note:
blocked.
If the airway pressure exceeds Check the patient and the
Mucus or secretions blocks the
the pre-set up-limits pressure, breathing system.
airway pipeline or endotracheal.
the expiring valve opens, if the Check settings of the ventilator
Patient ‘s coughing or breathing
system pressure is above and alarm limits.
rhythm is incompatible with the
125cmH2O, the safety valve
ventilator. alarm settings are
opens.
Improper. Breath bacteria filter is
blocked
The airway peek pressure is
below the pre-set lower limit
Check the patient and the
pressure.
Airway pressure is low breathing system.
The tidal volume is set too low.
Check the settings of the
The pipeline is falling off.
ventilation and the alarm limits.
Serious gas leakage.
Improper alarm settings.
Check the patient and the
The airway pressure is breathing system. Check settings
of the ventilator. If issues still
Continuous high pressure continuous above (PEEP+15)
exist,contact the maintenance
cmH2O for 15(±3)seconds. technician.

Check the oxygen supply


The oxygen supplying pressure pipeline, If issues still
Oxygen supply pressure low is below 2.8 kPa, the oxygen exist,contact with the
supplying pipiline is cut off. maintenance technician.

The probe of the Patient’s Remove water from the pipeline


The pipe is failed pipeline or breathing sensor has and check the humidifier settings,
malfunctions. such as the relative hummidity

Page 73 of 82
The Breathing sensor is settings.
disconnected. Check the heating cable of the
The breath sensor probe is humidifier(if installed).
pluged up. Check the pipeline connections
Ventilator breath sensor probe and the expiratory sensor probe
sampling tube stagnant water. connections.
The sampling tube of the sensor
probe is stored with water.
Leak excessive.
Connected to the main power
supply. Plug in the charged
The battery power modules can
The exhaustation of the battery battery modules.(connect the
maintain less than 5 minutes
ventilator to the power supply
and charge the battery modules).
The measured oxygen
concentration is lower than the
per-set value or even lower.
The gas supplied in the oxygen
tube is not oxygen.
The low-level of the inspiried The oxygen sensor is Check the oxygen supply
oxygen concentration malfunctioned or invalid. pipeline
The oxygen sensor has not been
calibrated.
The oxygen modules have
malfunction.

C.2 Medium priority alarms


Alarms content Possible reasons Solutions
Exceeding the pre-set value or Check the patient and the
the default alarm limit value. breathing system.
Minute volume high The ventilator triggers Check the settings of the trigger
automatically (auto-circle). sensitivity.
Improper alarm limit settings. Check the alarm settings.
Exceeding the pre-set value or Check the patient and the
the defaut alarm limit value. breathing system.
Note: this alarm is also for the Check the pipleline outlet hoop
disconnection of the patient. perssure.
Minute volume low The patient’s spontaneous Check the patient’s breathing
breathing is reduced. There is system(do the leak test if
leakage in the airwayand the possible)
patient’s breathing system. Check the paused time and the
The warning setting is improper. graphical display to verify.

Page 74 of 82
Considering use the ventilator to
increase the patient’s respiratory
support.
Plug in the new battery modules
The battery modules can
Battery power low or connected to the main power
maintain for less than 10 minutes
supply.
Check and connect the air
The air supply pressure is lower
supply pipeline. If issues still
Air pressure low than 280 kPa.
exist, contact with the
The air supply tube is cut off.
maintenance technicians.
The measured oxygen
concentration exeeds the pre-set
value or even more.
The gas supply device or the air
pipe line is disconnected.
No air in the gas supply pipe line
of the wall.
Check if the air supply pressure
O2 concentration low Check the air supply device.
is too low.
The air modules are cut off.
If failure to supply gas, the
expiratory vavle and the safey
valve will open.

Page 75 of 82
C.3 Low priority alarms
Alarms content Possible reasons Solutions
Check and take care of the
The breathing frequency is too
patient
high.
Frequency high Check the trigger settings.
Triggering automatically.
Check the connection of the
Leakage in the pipeline.
patient’s pipiline.
The breathing frequency is too
Check and take care of the
low.
patient
Improper setting of the trigger
Frequency low Check the trigger settings.
sensitivity.
Check the inspiratory terminate
High tidal volume.
settings.

Page 76 of 82
Appendix D Symbols and glossary

D.1 Glossary

Abbreviation /
Define
Terminology
VCV Volume control ventilation
PCV Pressure vontrol ventilation
SIMV Synchronized intermittent mandatory ventilation
PSV Pressure support ventilation
DualPAP Dual Positive Airway Pressure
SPONT Spontaneous breathing
VT Tidal volume, unit:mL
VTI Inspiration tial volume, unit:mL
VTE Expiration tial volume, unit:mL
MV Mechanical minute ventilation volume, unit:L
MVspn Spontaneously minute ventilaion volume, unit:L
Setting: mechanical ventilaion frequency; monitoring:total breathing
F
frequency; unit:bpm
fspn Spontaneous breathing frequency,unit:bpm
TI Inspiration time, unit:s
TP Breathing hold time,unit:s
I:E Inspiration and Expiration rate
PTRIG Pressure trigger, unit: cmH2O
FTRIG Flow trigger,unit: L/min or LPM
PEEP Positive expiration end pressure,unit: cmH2O
Psupp Pressure spport, unit: mH2O
Pinsp pressure control, unit:mH2O
Phigh High pressure level, unit:mH2O
Thigh High pressure time, unit:s
Plow Low pressure level, unit:mH2O
Ppeak Airway peek pressure, unit:mH2O
Pmean The average airway pressure, unit:mH2O
Pplat Inspiration platform pressure, unit: mH2O
Pmin Minimum airway pressure, unit:mH2O
ETS The expiration sensitivity, unit: %
FiO2 The oxygen concentration, unit: %

Page 77 of 82
Abbreviation /
Define
Terminology
R The airway resistance, unit:mH2O(L/s)
C Compliance, unit: mL/cmH2O
Weight Weight, unit:kg
Kg Kilogram
mL Milliliter
L Litre
bpm Bit per minute.

L/min或LPM Litre per minute

cmH2O Centimeter water column


Paw-T Pressure-time waveform
Flow-T Flow-time waveform
V-T Volume-time waveform
F-V Flow-volume loop
P-V Pressure-volume loop
F-P Flow-pressure loop
O2 Oxygen
HME Heat and moisture exchanger

D.2 Equipment symbols

expiration valve unlock


Alarm silence
label

AC power indicator light - + Battery indicator light

Screen and membrane


Screen and membrane button lock
button unlock

Inspiration port Expiration port

Indicate the high temperature


fuse
components, prevent scalding

Vendor-special data serial port Ethernet interface

Page 78 of 82
The Oxygen source
The air source connector
connector

RS 232
Vendor- special data port CE mark
Serial port

This symbol indicates TYPE B equipment according to the GB 9706.1 standard

ClassⅠ ClassⅠequipment

This symbol indicates protective ground. Connected to the external protective grounded
systems.

Equipotent terminals, used to connect the different parts of the equipment or the systems to

the same potential, does not absolutely refer to the grounded potential.

The exhausted batteries should not be disposed in a normal way. In some areas, there may

be no recycle facilities.

Proper disposal of products

D.3 Package symbols

THIS WAY UP FRAGILE

DO NOT ROLL KEEP AWAY FROM RAIN

KEEP AWAY FROM


STACK limit BY NUMBER
SUNLIGHT

Caution:
 Due to the different configuration, some symbols may be not entirely consistent to the

equipment, please take the equipment as valid.

Page 79 of 82
Appendix E Default settings
The table below lists the default settings when the ventilator exits the factory, if possible,

user can reset the parameter referring to the table:

Power on default settings

Patient category adult

Weight 65kg

Ventilation mode VCV

Ventilation parameter default settings

inspiration time:(s) 1.7

tidal volume : VT(mL) 450

respiration frequency: f(bpm) 12

Inspiration pause: TP(s) 0

PEEP(cmH2O) 0

Flow trigger: FTRIG(L/min) 2

Start-up alarm default settings

Tidal volume (mL) Lower limit: Adult:300/ pediatric:30

Upper limit: 20
Minute ventilation volume (L)
Lower limit: adult: 3/ pediatric:1

Upper limit: adult: 40/ pediatric:20


Respiratory frequency (bpm)
Lower limit: 0

Inspiratory oxygen concentration (%) Upper limit: 60, Lower limit: OFF

Airway pressure (cmH2O) Upper limit: 40, Lower limit: 0

End expiratory CO2 (mmHg) Upper limit: 60, Lower limit: 30

Continuous airway pressure (cmH2O) The airway pressure is > ( PEEP+15 ) cmH2O for 15

Page 80 of 82
seconds.

Apnea (s) Upper limit: 20

Page 81 of 82
Appendix F Reference
IEC 60601-1-2:2001 Medical electrical equipment -Part1-2: General Requirements for

Safety- Collateral standard: Electromagnetic compatibility-Requirements and tests.

EN 60601-1-1990 Medical electrical equipment Part 1 General requirements for safety

IEC 60601-1-1:1995 Medical electrical equipment Part 1: General requirements for safety

1. Collateral standard: Safety requirements for medical electrical systems.

IEC 60601-2-12:2001 Medical electrical equipment-Part2: Particular requirements for the

safety of lung ventilators-Critical care ventilators.

ESSE 3 Via Garibaldi 30


14002 Castelnuovo D.B.(AT) – I
tel +39 011 99 27 706
fax +39 011 99 27 506
e-mail esse3@chierinet.it
web : www.4ci.com

Page 82 of 82

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