Product Information

Product Name: Ventilator

Product Model: Boaray 2000C, Boaray 2000D

Version Information
The version number of this user manual may be updated due to the software

upgrades; Shenzhen Prunus Medical Co., Ltd. reserves the right to change it without

giving prior notice.

The version information:

 Version No.: M93-P-00224-8.0

 Release date: October 2019

I
CE Mark

Well Kang Limited (www.CE-marking.eu)

The Black Church, St. Mary's Place, Dublin 7, D07 P4AX, Ireland

This product bears a CE mark, as it conforms to European Council Directive for Medical

Devices (93/42/EEC), and meets the essential requirements of AnnexⅠof the directive.

This product meets the requirements of EN 60601-1-2 standard “Medical electrical

equipment - Part 1-2: General requirements for basic safety and essential performance -

Collateral Standard: Electromagnetic disturbances - Requirements and tests”.

Declaration
The intellectual property of the product and its document belongs to Shenzhen Prunus

Medical Co., Ltd. (hereinafter referred to as PRUNUS). PRUNUS reserves the final right of

interpretation for this document. Any unauthorized copying, storage, reproduction or

translation of this document in any form is strictly prohibited without the prior written

permission from PRUNUS.

Users can, if needed, ask for other technical information separately from PRUNUS in order

to understand, operate and maintenance the equipment, but should ensure the information

not obtained by the third party.

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

it conforms 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

malfunction occurs. Please contact the after service department of PRUNUS for repairing

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

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 PRUNUS.

Free Maintenance
The user reserves the right to be served for free repairs and replacement within 12 months

from the order delivered date only in the event that the product is purchased from PRUNUS

or the authorized distributor, it must be a new product when purchased and it is operated

according to the “User’s Responsibility”. Otherwise, PRUNUS has no responsibility for any

damages to the product.

Trademarks

, and are trademarks or registered

trademarks of PRUNUS.

III
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 apparatus. When you begin to use the

ventilator, we consider that you have read the manual carefully.

In order to use the equipment accurately, effectively and avoid the accident, 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 PRUNUS.

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 in the control panel.

IV
 Contents
Product Information ................................................................................................................I

After Service ...........................................................................................................................I

Version Information ................................................................................................................I

CE Mark .................................................................................................................................II

Declaration ............................................................................................................................II

User’s Responsibility ............................................................................................................III

Free Maintenance.................................................................................................................III

Trademarks...........................................................................................................................III

Preface ................................................................................................................................ IV

1 Safety Information ..............................................................................................................1

1.1 W ARNINGS ..................................................................................................................... 2
1.2 CAUTIONS ...................................................................................................................... 6

2 Equipment Description .......................................................................................................9

2.1 INTRODUCTION ............................................................................................................... 9
2.1.1 Intended use ......................................................................................................... 9
2.1.2 Applications ........................................................................................................ 10
2.1.3 Contraindications ................................................................................................ 10
2.1.4 System composition ........................................................................................... 10
2.1.5 Features .............................................................................................................. 11
2.2 SYSTEM OVERVIEW ...................................................................................................... 11
2.2.1 External pipeline connection diagram ................................................................ 12
2.2.2 Front view ........................................................................................................... 13
2.2.3 Rear view ............................................................................................................ 14
2.2.4 Bottom view ........................................................................................................ 15
2.3 POWER SUPPLY ............................................................................................................ 15
2.4 BATTERY ...................................................................................................................... 16
2.5 GAS SUPPLY ................................................................................................................. 18
2.6 SYSTEM SWITCH ........................................................................................................... 18
2.7 MEMBRANE BUTTONS.................................................................................................... 19
2.8 SCREEN DISPLAY.......................................................................................................... 22
2.9 VENTILATION MODES ..................................................................................................... 23
2.9.1 A/C (V) mode ...................................................................................................... 23
2.9.2 A/C (P) mode ...................................................................................................... 24
2.9.3 SIMV mode ......................................................................................................... 24
2.9.4 SPONT mode ..................................................................................................... 25
2.9.5 PRVC mode ........................................................................................................ 26
2.9.6 CPAP mode ........................................................................................................ 26
2.9.7 DualPAP mode ................................................................................................... 27

V
 2.9.8 Backup ventilation mode .................................................................................... 28
2.10 ALARM SYSTEM ............................................................................................................ 28
2.10.1 General description ............................................................................................ 28
2.10.1.1 Alarm categories...................................................................................................... 28
2.10.1.2 Alarm priorities......................................................................................................... 29
2.10.1.3 Alarm signals ........................................................................................................... 29
2.10.1.4 Alarm information and priority .................................................................................. 30
2.10.2 Alarm silence ...................................................................................................... 31
2.10.3 Alarm limit setting ............................................................................................... 32
2.10.4 Alarm volume setting .......................................................................................... 32

3 Disassembling and assembling........................................................................................33

3.1 BATTERY MODULE ......................................................................................................... 33
3.2 OXYGEN SENSOR ......................................................................................................... 33
3.3 PATIENT SYSTEM........................................................................................................... 36
3.4 EXHALATION VALVE ....................................................................................................... 37
3.5 GAS SUPPLY ................................................................................................................. 39
3.6 HUMIDIFIER .................................................................................................................. 39

4 Pre-use check ..............................................................................................................42

4.1 SYSTEM CHECK ............................................................................................................ 42
4.2 FUNCTION CHECK ......................................................................................................... 43
4.3 ALARM TEST ................................................................................................................. 45
4.3.1 Pre-test preparations .......................................................................................... 45
4.3.2 Airway pressure high alarm ................................................................................ 45
4.3.3 Tidal volume low alarm ....................................................................................... 45
4.3.4 O2 concentration low alarm ................................................................................ 46
4.3.5 Circuit disconnected alarm ................................................................................. 46
4.3.6 Battery in use alarm ............................................................................................ 46
4.3.7 Tube obstruction alarm ....................................................................................... 46
4.3.8 Tube partial occlusion alarm ............................................................................... 47
4.3.9 Oxygen supply pressure low alarm .................................................................... 47
4.3.10 Continuous airway pressure high alarm ............................................................. 47
4.3.11 Apnea alarm ....................................................................................................... 47

5 Operations and Settings ...................................................................................................48

5.1 KEYS ........................................................................................................................... 48
5.2 BOOT SELF-TEST .......................................................................................................... 49
5.3 STANDBY SCREEN ........................................................................................................ 49
5.4 PATIENT SETTING ......................................................................................................... 50
5.5 STANDBY ..................................................................................................................... 51
5.6 MAIN SCREEN ............................................................................................................... 52
5.7 MODE SETTING ............................................................................................................. 55
5.8 SYSTEM SETTINGS ........................................................................................................ 58
5.8.1 General settings ................................................................................................. 58
5.8.2 Alarm setting ....................................................................................................... 59

VI
 5.8.3 System log .......................................................................................................... 60
5.8.4 Biomed................................................................................................................ 61
5.8.5 Version information ............................................................................................. 61
5.9 POWER OFF THE VENTILATOR ........................................................................................ 62

6. User Maintenance ...........................................................................................................63

6.1 CLEANING AND DISINFECTION ....................................................................................... 64
6.2 MAINTENANCE SCHEDULE ............................................................................................. 68
6.3 VENTILATOR SURFACE .................................................................................................. 69
6.4 EXHALATION VALVE ...................................................................................................... 69
6.5 BREATHING TUBES........................................................................................................ 70
6.6 BATTERY...................................................................................................................... 70
6.7 OXYGEN SENSOR ......................................................................................................... 71
6.8 TURBINE AIR INLET DUST FILTER .................................................................................... 72

Appendix A Working Principle .............................................................................................73

A.1 PNEUMATIC CIRCUIT PRINCIPLE ......................................................................................... 73
A.2 PNEUMATIC CIRCUIT DIAGRAM ......................................................................................... 74

Appendix B Product Specifications .....................................................................................75

B.1 SYSTEM ....................................................................................................................... 75
B.2 TECHNICAL PARAMETERS .............................................................................................. 76
B.3 SETTING PARAMETERS.................................................................................................. 77
B.4 MONITORING PARAMETERS ........................................................................................... 78
B.5 ALARM SETTING PARAMETERS ....................................................................................... 79

Appendix C Alarms ..............................................................................................................80

C.1 HIGH PRIORITY ALARMS ................................................................................................. 80
C.2 MEDIUM PRIORITY ALARMS ............................................................................................ 82
C.3 LOW PRIORITY ALARMS ................................................................................................. 83

Appendix D EMC .................................................................................................................84

Appendix E Glossary and Symbols .....................................................................................92

E.1 GLOSSARY ................................................................................................................... 92
E.2 SYMBOLS ..................................................................................................................... 94
E.3 PACKAGE SYMBOLS ...................................................................................................... 96

Appendix F Default settings ................................................................................................97

VII
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.

If you have a question regarding the installation, set up, operation, or maintenance of the

ventilator, contact the after-service department of PRUNUS.

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.

1
1.1 Warnings

Warnings:
 Boaray2000 series ventilator is a restricted medical device intended for use by

qualified, trained personnel. Operations of the equipment should be strictly

according to the user manual.

 Only those conform to the latest IEC 60601-1 standard accessories and auxiliary

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

computer, monitor or humidifier has been connected to the ventilator, the whole

system should meet the IEC 60601-1 standard.

 All analog or digital products connected to this system must be certified passing the

specified IEC standards (such as IEC 60601-1 for medical electrical equipment and

IEC 60950 for safety of information technology equipment). All configurations shall

comply with the valid version of IEC 60601-1. The personnel who are responsible for

connecting the optional equipment to the I/O signal port shall be responsible for

medical system configuration and system compliance with IEC 60601-1-1.

 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:

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

clothes to minimize the possibility of the static gathering.

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

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

2
 Warnings:
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.

 To avoid personnel injury and the risk of electric shock, as well as damage to the

ventilator, do not operate the ventilator with its covers or panels removed. Refer all

servicing to the service technician certified by PRUNUS.

 Care should be taken to ensure that the patient does not disconnect from the

breathing circuit. Such disconnections could be hazardous to the patient.

 Do not operate the ventilator without setting the alarms. All alarms must be set to

ensure safe operation.

 Do not operate the ventilator unless qualified personnel are in attendance to

promptly respond to alarms, inoperative conditions, or sudden malfunctions.

Patients on life-support equipment should be visually monitored at all times.

Qualified personnel should be prepared to provide an alternate form of ventilation, if

needed.

 Alarm sound level should be higher than the ambient sound, so that the monitoring

personnel can hear the alarms.

 Before the battery runs out, please use the AC power supply.

 Check all audible and visual alarms daily to make sure they are operating properly. If

an alarm fails to active, contact the service technician certified by PRUNUS.

 Make sure a backup ventilation plan is always available.

 Low air density at high altitudes affects tidal volume delivery and exhaled tidal

volume measurements.

 Do not try to service or repair an improperly functioning ventilator yourself. Contact

the service technician of PRUNUS for all repairs and service.

 Do not use parts, accessories, or options that have not been authorized for use with

the ventilator. Using unauthorized parts, accessories or options may be harmful to

the patient or damage the ventilator.

 Check the exhalation valve diaphragm daily to ensure that it is not worn or

3
 Warnings:
damaged. A worn or damaged exhalation valve diaphragm may result in improper

patient ventilation. Replace the diaphragm as necessary.

 If mechanical or electrical problems are found during use, you must stop using the

ventilator and contact the qualified service technician for maintenance. Using

improperly functioning ventilator may be harmful to the patient.

 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.

 This equipment can only be used in the specified environment, and 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.

 When external devices are attached to the ventilator, it may cause increase of the

leakage current.

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

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

avoid electric shock.

 Not to draw tracheal cannula forcefully, and do not distort and fold the tracheal

cannula in application to avoid unexpected danger.

 When attaching accessories, components or assemblies to the breathing system,

the pressure gradient that the breathing system relative to the patient connection

port may increase.

 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.

4
 Warnings:
 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 alarm occurs, discontinue use of the ventilator and check it at once,

replace the corresponding components as occasion requires.

 Set the alarm limit to a proper value in order to ensure patient safety.

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

barotrauma, hypoventilation, hyperventilation or circulatory injury.

 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.

 The equipment will produce some castoff, the one-off parts or the damageable parts

which will lead to serious pollute or cross infection if discarded randomly, and should

be managed and disposed according to the relative regulations.

 When the equipment or the accessories are about to exceed the limit time, they

should be disposed according to the local regulations or the hospital systems.

5
1.2 Cautions

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

who have received specialized training. Please refer to the chapter 6 for the

maintenance time interval information. All service performed on the ventilator

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

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

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

authorized by PRUNUS.

 Users must take the related responsibility for any malfunction which results from the

package or product disassembled by the user.

 PRUNUS 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 auxiliary equipment cannot be regarded as the basic of treatment

or diagnosis decisions. Such decisions can only be made by the experienced

medical personnel based on the previous or accepted manner. PRUNUS has no

responsibility for the accuracy of the signal handling if auxiliary equipment not

provided by PRUNUS is used with the ventilator system.

 If there are differences 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 auxiliary equipment not provided by PRUNUS. As for the safety

of the electrical system, only those accorded with the latest IEC 60601-1 standard

accessories and auxiliary equipment could be connected to the signal input and

output interface of the ventilator system.

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

6
 Cautions:
PRUNUS can be used to be connected to the ventilator system. Otherwise it may

cause damage or security to the system.

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

the system or optional accessories.

 The gases used in the system must conform to the following standards for

concentrations of water vapor and oil:

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 ≈ 14.5psi

 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 from 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.

 Do not over clean the ventilator. Repeated use of a cleaning agent can cause

residue build-up on critical components. Excessive residue build up can affect

ventilator performance.

 When cleaning the ventilator, do not use harsh abrasives. Do not immerse the

ventilator in liquid sterilizing agents or liquids of any kind. Do not spray cleaning

solution directly onto the front panel. Do not allow cleaning solution to pool on the

front panel.

 Do not insert cleaning instruments (such as a cloth, brush, or pipe cleaner) into the

flow sensor.

 Do not use high pressure gas nozzle to dry the flow sensor, high pressure gas may

7
 Cautions:
damage the flow sensor.

 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.

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

conducting.

 The ventilator contains no latex element.

 Make sure there is at least one battery as backup power supply.

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

someone professional to monitor the system operation.

 Do not store the ventilator in hot areas for prolonged periods of time. High

temperatures can shorten battery life.

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

 Always use a Heat and Moisture Exchanger (HME) or other equivalent equipment

to prevent the dehydration of the lung system.

 When disposing of the old oxygen sensor, observe the relevant regulations for

biohazard and do not burn it.

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

regulations and in an environmental safe way.

Note:
 When the system is not used, it is recommended the device is connected to the

main power supply in order to keep the battery power.

 If the system is connected to the main power supply, even if the system switch is in

the closed state, the main power supply of the system is not interrupted.

8
2 Equipment Description

2.1 Introduction

2.1.1 Intended use

The ventilator system is an easy to use, turbine-driven, computer controlled ventilator. It

has a color LCD with real time graphics display and digital monitoring capabilities,

membrane buttons and a knob for changing settings. 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 patients or support ventilation. Doctors can control

the patients timely by real-time monitoring the multi-respiratory parameters of the ventilator

to ensure patients safety and good treatment.

The ventilator is intended for treating and monitoring adult and pediatric patients with

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

hospitals or in health care facilities, or during transport of a patient.

The Boaray 2000 series ventilator has two models: Boaray 2000D and Boaray 2000C, the

differences of their configurations are shown as below:

Configurations /Models Boaray 2000C Boaray 2000D

DualPAP / Optional

PEEP 0～30 cmH2O 0～40 cmH2O

VT 50～2000 mL 20～2000 mL

9
2.1.2 Applications

1. Acute respiratory failure caused by various causes, including respiratory distress

syndrome（ARDS）.

2. Acute exacerbation of chronic respiratory failure.

3. Severe acute pulmonary edema and persistent asthma.

4. Pediatric cardiac surgery in patients with postoperative ventilation support.

5. The patients with respiratory insufficiency were examined by bronchoscopy, cervical

and tracheal surgery, usually with high frequency ventilation support.

2.1.3 Contraindications

Contraindications that should be noted when operating the ventilator:

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.

2.1.4 System composition

This ventilator consists of the main unit and power supply.

Warning:
 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.

10
2.1.5 Features

The ventilator provides following extensive features:

1. Use the touch screen to select the ventilation modes and parameters easily and

conveniently.

2. A broad range of operating modes.

3. Electronic PEEP.

4. Accurate ventilation parameters monitoring and display.

5. Clearly audible and visual alarms.

6. Real-time display of waveforms.

7. Flow-Volume, Volume-Pressure and Flow-Pressure loops display.

8. Day and night mode.

2.2 System Overview

Note:
 The illustration in this section is only for reference, due to different configuration, the

illustration may not be entirely consistent to the product.

11
2.2.1 External pipeline connection diagram

Figure 2-1 External pipeline connection view

1. Ventilator main unit 2. Expiratory breathing tube

3. Y piece 4. Flow sensor probe

5. Flow sampling probe 6. Water trap

7. Humidifier 8. Inspiratory breathing tube

9. O2 supply pipeline 10 Power cable

12
2.2.2 Front view

Figure 2-2 Front view

1. Waste gas outlet 2. Expiratory port 3. Expiratory valve rotation indication

4. Expiratory valve unlock button 5. Expiratory label 6. Nebulizer port

7. Flow sensor sampling ports

（Up: low pressure, white; 8. Speaker 9. Leak test plug

Down: high pressure, blue）

10. Inspiratory label 11. Inspiratory port 12. Knob

13. Touch screen 14. Alarm indicator 15. Button area

16. Battery indicator 17. AC power indicator

13
2.2.3 Rear view

Figure 2-3 Rear view

3. Label for O2 inlet, oxygen sensor,

1. Handle 2. Ventilator nameplate
and maintenance interfaces

4. O2 inlet 5. O2 sensor port (inside cover) 6. Turbine air inlet (inside cover)

7. Air inlet cover

8. System switch 9. Power cable fixer
(with dust filter)

10. Label for system switch,

11. AC power port 12. Equipotential earthing rod
AC power and earthing

15. Maintenance interface cover

13. Battery cover 14. Heat dissipation outlet (including USB, RS232, and network

interfaces)

14
2.2.4 Bottom view

Figure 2-4 Bottom view

1. Safety valve filter 2. Bottom fan air intake dust filter

2.3 Power supply

1. Power supply specification:

Input voltage: 100～240Va.c., Frequency: 50/60Hz, Current input: 2A (Max.).

2. Fuse specification: T2AL/250V.

3. AC power indicator:

 When the ventilator is connected to AC power, the “AC” indicator lights.

 When the ventilator is not connected to AC power, the “AC” indicator is off.

15
2.4 Battery

Caution:
 Exhausted batteries should be disposed according to the local regulations, and

cannot be disposed in a normal way.

 Use an AC power source supply before the internal battery power source is

depleted.

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

 The battery life depends on the frequency and time of use. Using the batteries in an

improper way will affect the battery life.

Note:
 Remember to charge the battery. When the ventilator is connected to the power

supply, it will charge the battery automatically.

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

 If the battery is stored for a long period and it has been discharged, it needs an

extended period to be charged.

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

 The internal battery is capable of providing power during AC power interruptions,

and the fully-charged battery can provide power for more than 120 minutes in the

standard work state.

 When transporting the patient, we recommend that the time spent transporting the

patient should not exceed 50% of the maximum battery using time. This will leave

some leeway in the event of unexpectedly delay or battery runs out. A backup

manual breathing equipment should be available at any time when transporting the

patient.

16
1. Battery specification

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

The ventilator is equipped with the internal battery. It is recommended that there is always

a battery module as backup power supply.

The backup battery of the ventilator is rechargeable lithium battery. When the ventilator is

connected to the main power supply and turned on, the inserted battery module will be

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

supply automatically, simultaneously, it will emit a battery in use alarm to prompt users, and

will not lead to interruption of the ventilator work.

The internal battery specification: 11.1VDC, 12000mAh.

2、Battery status alarms

When the battery is providing the primary source of power for the ventilator, the status of

the battery modules is continuously monitored by the ventilator. If the battery capacity is

insufficient, the ventilator will generate 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 “Battery is exhausted” alarm appears, the remaining time is about 5

minutes.

The fully-charged battery can provide power for more than 120 minutes in the standard

work state. The battery module should be charged for more than 10 hours.

3、Battery status indicator

There is visual status indicator on the front panel of the ventilator for the internal battery.

Internal battery status indicator:

17
  The indicator is lit whenever the internal battery is proving the primary source of

power for the ventilator.

 The indicator is flashing green when the ventilator is connected to the external

AC power and the internal battery is in charging.

 The indicator is constant orange when the internal battery is proving power for

the ventilator and the battery charge is 30%～80%.

 The indicator is flashing orange when the internal battery is proving power for the

ventilator and the battery charge falls below 30%.

2.5 Gas supply

The gas supply of the ventilator is Oxygen (O2), and the rated pressure range is 0.28 to

0.6Mpa. Gas may be supplied by a medical pipeline system or by gas cylinder. A filter and

a non-return valve are equipped in the gas supply circuit, the pressure is decreased to the

rated pressure range 0.28～0.6Mpa by the pressure regulator. When using cylinder for gas

supply, the output pressure will be regulated to 0.28～0.6Mpa by the pressure regulator.

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

pressure reduces to affect the ventilation, it will generate an alarm to notify the users.

2.6 System switch

The system switch is located on the rear panel of the ventilator. The specially designed

protector can avoid touching or impacting the switch accidentally.

18
2.7 Membrane buttons

Figure 2-5 Knob and membrane buttons

1. Knob
Turn: Switch among the function options, turn it clockwise to increase the parameter

value, or anticlockwise to decrease the parameter value.

Push: Push down to confirm settings or access menus.

2. Freeze button
Press this button to enter freeze status. In this status, the system temporarily pauses

the real-time refreshing of waveforms on the screen, so that you can review specific

patient data. Press this button again to exit the freeze status and go back to normal

work status. This status is automatically exited within 30 seconds.

3. Inspiratory hold button

Press this button to enter inspiratory hold status after the termination of the current

inspiratory phase. This status lasts 30 seconds. It extends the patient’s time of

inspiratory phase manually and prevents the patient from expiration for this period of

time. Press this button again to terminate the inspiratory hold status and go back to

normal work status. The inspiratory hold status automatically exits after 30 seconds.

19
4. Expiratory hold button
Press this button to enter expiratory hold status after the termination of the current

expiratory phase. This status lasts 30 seconds. It extends the patient’s time of

expiratory phase manually and prevents the patient from inspiration for this period of

time. Press this button again to terminate the expiratory hold status and go back to

normal work status. The expiratory hold status automatically exits after 30 seconds.

5. Extra breath button

After pressing this button, the ventilator system will deliver a breath to the patient

based on the current ventilation mode. Pressing this button during expiratory phase

can start a manual breath. When doing this during inspiratory phase, the system will

deliver a breath during the current expiratory phase.

6. 100% O2 2mins button

When O2 supply is connected to the ventilator, after pressing this button, the ventilator

will deliver 100% pure oxygen to patient for 2 minutes. When the 2-minute period of

oxygen enrichment completes or this button is pressed again, the ventilator terminates

the 100% oxygen enrichment and restores to the previous oxygen concentration.

7. Nebulizer button
When O2 supply is connected to the system and a nebulizer is attached to the

ventilator, and the minimum flow is more than 10 L/min, after this button is pressed,

the ventilator will automatically supply 7L/min (±0.5L/min) gas to the patient in

inspiration phase, and the nebulization time can be selected in 10min, 20min and

30min (in Auxiliary settings screen). You may end the nebulization period early by

pushing this button again.

8. Standby button
Press this button and then the knob to confirm to access standby mode.

20
9. System setting button

Press this button to access the system setting screen.

10. Mode setting button

Press this button to access the mode setting screen.

11. Alarm silence button

In the case of an active alarm, press this button to pause the alarm audio of this alarm

for 100 seconds.

21
2.8 Screen Display

The ventilator has a color LCD which can display the parameters and graphics clearly. The main screen

of the ventilator is shown as below, for more information about other screens refer to Chapter5

Operations and Settings.

Figure 2-6 Main screen

Figure 2-7 Main screen area

22
1. Ventilation mode area

Display the current ventilation mode.

2. Alarm message display area

Display the current alarm message.

3. Status information display area

1） Display the freeze icon.

2） Display the CPAP icon.

3） Display the patient category icon.

4） Display the alarm/alarm silence icon.

5） Display the battery charge icon.

6） Display the system date and time.

4. Measured parameters area

Display measured parameters of the current patient.

5. Waveform area

Display waveforms and loops as per the monitoring of the current patient.

6. Parameters setting area

Users can set relative ventilation parameters of the current ventilation mode on the main screen

directly.

2.9 Ventilation modes

The ventilator provides varieties of ventilations modes. It meets the most patient’s demand.

2.9.1 A/C (V) mode

A/C (V), Assist/Control (Volume), volume breath with assist ventilation. In A/C (V) mode, the ventilator

works at the pre-set tidal volume, respiratory rate, inspiratory time, etc. When the patient triggers the

ventilator, the ventilator delivers gases to the patient at the set tidal volume, inspiratory time, etc.

In A/C (V) mode, the following parameters need to be set:

- 【VT】

- 【RR】
23
 - 【Ti】

- 【Tp】

- 【FiO2】

- 【PEEP】

- 【Ftrig /Ptrig】

2.9.2 A/C (P) mode

A/C (P), Assist/Control (Pressure), pressure breath with assist ventilation. In A/C (P) mode, the ventilator

works at the pre-set inspiratory pressure, respiratory rate, inspiratory time, etc. When the patient triggers

the ventilator, the ventilator delivers gases to the patient at the set pressure, inspiratory time, etc.

In A/C (P) mode, the following parameters need to be set:

- 【Pinsp】

- 【RR】

- 【Ti】

- 【FiO2】

- 【PEEP】

- 【Ftrig /Ptrig】

- 【Prate】

2.9.3 SIMV mode

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

frequency and the 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 met in the trigger window, at the end of the trigger window, the ventilator will provide a

volume (or pressure) control ventilation.

SIMV mode is combined with PSV (Pressure Support Ventilation) mode; it’s divided into the following

two modes:
24
SIMV (P) + PS, SIMV (Pressure) + Pressure Support, Pressure breath with SIMV.

SIMV (V) + PS, SIMV (Volume) + Pressure Support, Volume breath with SIMV.

Different mode determines whether the volume or pressure control ventilation is selected.

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

- 【Psupp】

- 【SIMVrate】

- 【Ti】

- 【VT】or【Pinsp】

- 【FiO2】

- 【PEEP】

- 【ETS】

- 【Tp】

- 【Prate】

- 【Ftrig /Ptrig】

2.9.4 SPONT mode

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

the breathing rhythm themselves, when the triggering level is met, the ventilator will provide ventilatory

support at 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, the following parameters need to be set:

- 【FiO2】

- 【ETS】

- 【PEEP】

- 【Psupp】

- 【Ftrig /Ptrig】

- 【Prate】
25
 - 【Tapnea】

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

patient is asphyxial. Please refer to section 2.9.8 Backup ventilation mode for more information.

2.9.5 PRVC mode

PRVC (Pressure Regulated Volume Control). In PRVC mode, inspiration is accomplished at the pre-set

tidal volume and respiratory rate within the pre-set inspiratory time, each inspiration is automatically

adapt to the controlled inspiratory pressure, which changes the characteristic of the lung or thoracic to

ensure using of the minimum pressure to deliver the pre-set tidal volume and minute volume. The

inspiratory pressure keeps constant throughout the whole pre-set inspiratory time.

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

- 【Ti】

- 【RR】

- 【FiO2】

- 【VT】

- 【PEEP】

- 【Ftrig /Ptrig】

- 【Prate】

- 【Plimit】

2.9.6 CPAP mode

CPAP is the continuous positive airway pressure ventilation mode. During the whole ventilation period,

the system maintains the airway pressure at the positive pressure level preset by users; the patient’s

respiration is completely spontaneous; respiratory rate, respiratory time and respiratory volume are all

decided by the patient. When the system detects that the period during which the patient has no

spontaneous respiration exceeds the preset apnea time, the apnea alarm condition occurs, and the

ventilator automatically switches to a predetermined ventilation mode that generates controlled breaths.

26
In CPAP mode, the following parameters need to be set:

- 【FiO2】

- 【PEEP】

- 【Ftrig /Ptrig】

- 【Tapnea】

Users can set the backup ventilation in the CPAP mode, providing the mandatory ventilation when the

patient is asphyxial. Please refer to section 2.9.8 Backup ventilation mode for more information.

2.9.7 DualPAP mode

DualPAP (Dual Positive Airway Pressure). In DualPAP mode, the ventilator forms the high pressure level

and low pressure level according to the pre-set value, and switches based on the pre-set frequency and

inspiratory time. Patients can breathe spontaneously at the high pressure and low pressure level if

trigger occurs, and the ventilator provides support ventilation according to the pre-set pressure. In this

ventilation mode, the sigh function is not available.

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

- 【Phigh】

- 【Plow】

- 【Ti】

- 【RR】

- 【FiO2】

- 【PShigh】

- 【PSlow】

- 【ETS】

- 【Ftrig /Ptrig】

- 【Prate】

27
2.9.8 Backup ventilation mode

In SPONT and CPAP modes, when the patient’s apnea time reaches the pre-set value, the apnea alarm

condition occurs and the ventilator automatically switches to a predetermined ventilation mode that

generate controlled breaths based on the backup ventilation mode and parameters.

The backup ventilation mode provides A/C (V) and A/C (P) modes.

In A/C (V) mode, the following parameters need to be set:

- 【VT】

- 【Ti】

- 【RR】

In A/C (P) mode, the following parameters need to be set:

- 【Pinsp】

- 【Ti】

- 【RR】

2.10 Alarm System

2.10.1 General description

The ventilator is designed with an alarm system to ensure patient’s safety. When alarm occurs, the alarm

indicator, alarm sound and visual alarm message will warn the user.

2.10.1.1 Alarm categories

According to the characteristic of the alarm, the ventilator alarms are grouped into physiological alarms

and technical alarms.

1. Physiological alarms

The monitored parameters or the patient physiological parameters exceed the specified range.

2. Technical alarms

Due to improper operations or technical malfunctions, the ventilator fails to monitor accurately.

28
2.10.1.2 Alarm priorities
According to importance of alarms, the ventilator alarms are grouped into three categories: High priority,

Medium priority and Low priority.

1. High priority

When high priority alarms occur, the patient’s life may be threatening, or the equipment may fail

to work, require immediate action.

2. Medium priority

When medium priority alarms occur, some parameters may be set incorrectly, and the patient

may be in danger if malfunctions last a long time. Users should adjust parameters to clear the

malfunctions.

3. Low priority

When low priority alarms occur, it will not endanger the patient’s life, there may be some

incorrect settings or unimportant malfunctions, users should adjust the setting parameters or

eliminate malfunctions after using the equipment.

2.10.1.3 Alarm signals

Depending on alarm priorities, alarms have different visual and audible signals.

1. High priority alarms:

- Alarm indicator light: Red, flashes at a rate of 1.4 to 2.8Hz (fast).

- Alarm tone: du-du-du-du-du -----du-du-du-du–du, the interval between each alarm audio is 10

sec.

- Alarm message: The alarm message display area is red.

- Red background

2. Medium priority alarms:

- Alarm indicator light: Yellow, flashes at a rate of 0.4 to 0.8 Hz (slow).

- Alarm tone: du-du-du, the interval between each alarm audio is 25 sec.

- Alarm message: The alarm message display area is yellow.

3. Low priority alarms:

- Alarm indicator light: Yellow, not flash.

- Alarm tone: du, the interval between each alarm audio is 25 sec.

- Alarm message: The alarm message display area is yellow.

29
2.10.1.4 Alarm information and priority

Alarm type Message Alarm priority

Tidal Volume Low Medium

Minute Volume High Medium

Minute Volume Low Medium

Frequency High Low

Frequency Low Low

O2 Concentration High Medium

Physiological alarm
O2 Concentration Low High

Airway Pressure High High

Airway Pressure Low High

High Continues Pressure High

PRVC Pressure Limited High

Apnea High

Oxygen supply pressure low High

System leakage High

O2 sensor is not connected or failure High

Inspiratory P_Sensor Failure High

Expiratory P_Sensor Failure High

Low battery capacity Medium

Battery discharged High

Battery failure High

Circuit disconnected High

Technical alarm Tube obstruction High

Tube partial occlusion Medium

5V supply error High

12V supply error High

22V supply error High

Battery in use Low

Power board error Low

PEEP Valve Failure High

O2 Valve Failure High

Air Inlet Filter Blocked High

Table 2-1 Alarm information and priority

30
 Note:
 When different priorities of alarms occur simultaneously, the alarm indicator and alarm tone will

show the characteristic of the alarm with the highest priority.

 If high priority alarms and medium priority alarms occur simultaneously, the alarm indicator light

flashes in red.

 If multiple alarms occur, the alarm messages will display in the alarm message display area

according to the alarm priority, alarms with the higher priority display at the top and lower priority

alarms display at the bottom.

2.10.2 Alarm silence

In the event of an alarm, press the membrane button to pause the alarm audio of

currently active alarm for 100 seconds and enter an alarm audio paused status. Meanwhile, the alarm

silence icon and 100-second countdown show one after another repeatedly at the upper-right
corner of the screen. If this status exceeds 100 seconds, it will be cancelled and the audible alarm tones

are restored. Press again during the alarm audio paused status, this status terminates
and the alarm tones start again.

Warning:
 During the period of alarm audio paused, pay close attention to the patient and ventilator to

ensure no alarm messages are ignored. Possible patient or equipment hazard may be produced if

the alarm continues while no action is taken.

Note:
 Under the alarm audio paused status, the alarm indicator and alarm message still work normally

31
 except the alarm audio.

 If a new alarm is triggered in the alarm audio paused status, this status will be cancelled and

alarm tones will be restored according to this alarm.

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

2.10.3 Alarm limit setting

Refer to section 5.9.2 Alarm setting for the detailed operations of alarm limit setting.

Caution:
 Please always pay attention to the alarm limit settings and make sure they are set properly and

reasonably to avoid inaccurate alarms.

 When mains power is interrupted, the alarm limit setting does not change and the system saves

the latest setting before interruption.

2.10.4 Alarm volume setting

Refer to section 5.9.1 General setting to set the alarm volume.

Warning:
 When operating the ventilator, users cannot rely on the audible alarm completely. The low alarm

volume may lead to risk of patient. Users should pay attention to the actual clinical condition of the

patient.

32
3 Disassembling and assembling

3.1 Battery module

1. Assembling

Please assembly the battery module as per the following:

1） As the figure shown below, remove the battery cover on the rear of the main unit, insert the

battery module.

2） Put the battery cover back.

3） Install the screw and tighten.

Figure 3-1. Battery module installation view

2. Disassembling

Unscrew the screw to remove the battery cover, and draw out the battery module.

3.2 Oxygen sensor

1. Assembling

Please assembly the oxygen sensor as per the following:

1) Loosen the screw to remove the baffle, it shown as below.

2) Remove the air inlet cover by pressing the fastener.

33
 Figure 3-2. Remove air inlet cover view

3) As shown in the below figure, screw down the new oxygen sensor clockwise, and then plug the

oxygen sensor connection wire into the oxygen sensor interface.

4) After replacement is completed, install the air inlet cover and baffle, and then tighten the screw.

Figure 3-3. Oxygen sensor installation view

2. Disassembling

1） Turn off the ventilator by setting the system switch located on the rear of the main unit.

2） Cut off the power supply and gas supply of the ventilator.

Figure 3-4. Power supply and gas supply disconnection view

3） Loosen the screw and remove the baffle.

4） Take off the air inlet cover by pressing the fastener.

34
 Figure 3-5. Remove air inlet cover view

5） Unplug the oxygen sensor connection wire, then remove the oxygen sensor by turning it

anticlockwise, as shown below:

Figure 3-6. Oxygen sensor disassembly view

35
3.3 Patient system

1. Assembling

Figure 3-7. Patient system connection view

Connect the patient system as the figure shown above.

1. Patient pipeline 2. Y-piece

3. Blue silicon hose 4. White silicon hose

5. Flow sensor probe 6. Snake-shaped tube

7. Test lung 8. Water trap

9. Humidifier

Note:
 To avoid an acute angel of pipeline when installing or connecting, and Keep the proper length of

36
 pipeline, and avoid the distortion of connectors.

 It is attached to patient end while connecting nebulizer, otherwise it will impact on VT value. The

connection methods refer as the above picture.

 When sampling hose connected, the colors of white silicon hose and blue silicon hose should

correspond with the colors of main unit’s port and flow sensor sampling probe.

 When using the nebulizer, it need install bacteria filter onto expiration end.

2. Disassembling

Remove the pipelines and the middle joint parts as the figure shown above. Note that do not drag the

pipeline when it is far away from the joint, should hold the joint and pull out carefully.

3.4 Exhalation valve

1. Assembling

Please assembly the expiratory valve as per the following:

1） Carefully seat the diaphragm on the expiratory valve housing (sheet metal inward), and gently

press around the rim to insure it is seated evenly. Line up the Y-piece with the openings in the

exhalation valve housing and seat it in place.

Figure 3-8. Exhalation valve installation view I

2） Gently press and rotate the Y-piece anticlockwise until you can hear a click means it should be

in place. Note that the exhalation diaphragm is in place to avoid leakage before installing

Y-piece.

37
 Figure 3-9. Exhalation valve installation view II

2. Disassembling

1） Before disassembling, Press “ ” button to unlock.

Figure 3-10. Exhalation valve disassembly view I

2） Gently rotate the Y-piece clockwise and put out it by your hands, and then take off the

exhalation diaphragm.

Figure 3-11. Exhalation valve disassembly view II

38
3.5 Gas supply

1. Assembling

Figure 3-12. Gas supply connection view

Cut off the oxygen supply, and then use a monkey wrench or a special wrench to screw down the oxygen

supply connection pipeline①.

2. Disassembling

Cut off the oxygen supply, and then use a monkey wrench or a special wrench to remove the oxygen

supply connection pipeline.

3.6 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. It should only be

operated trained medical personnel.

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

authorized personnel for repairs.

39
 The humidifier connection diagram is as below:

Figure 3-13. Humidifier connection diagram

The preparation before start-up:

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

must be lower than the patient.

2. Put the humidifier water container on the front block-ring, press 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 inlet 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 the

water 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

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

40
  Water quality requirement: should use the distilled water, otherwise, it will affect the life of the

device.

 When the temperature inside the heating plate reaches to 92±5°C, the overheated protective

relay will disconnect the humidifier power supply, the power indicator light turns off, when it is

cooling, the overheated protective relay will reset automatically and connected to the power

supply, the power indicator light turns on.

 The overheated 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 PRUNUS.

2. Disassembling:

1） Disassembling the humidifier water container

① Close the humidifier, pull out the gas inlet and outlet pipelines that connected to the humidifier.

② Press 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

① Hold 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.

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

plate is in place.

41
4 Pre-use check

4.1 System check

Before using the ventilator, please read and understand the operations and maintenance of each part of

the equipment, and make sure the equipment meets the following requirements.

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

2. All the components are connected correctly.

3. The buttons work normally.

4. Test the alarm volume and adjust it to an appropriate level.

5. The ventilator system is connected correctly, and the pipelines are with no damage.

6. The gas supply system is connected correctly and the pressure is normal.

7. The emergency equipment is in ready and in good condition.

8. All the facilities used for the maintenance of the pipelines and intubations are available and in good

condition.

9. Connect the power cord to the AC power, the AC power indicator and the battery indicator will

illuminate, if not, the system has no electricity.

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

 The power cable of the ventilator should be plugged into the protective grounded mains power

outlet.

 If any functional malfunctions are detected during the ventilator system start-up, and the

malfunctions persist, the ventilator cannot be connected to the patient.

 Check the O2 concentration value from set value and measured value, if value has a large

deviation, calibration is required only by the authorized serviceman of PRUNUS. If the problem

persists, O2 sensor is replaced.

42
4.2 Function check

Caution:
 If the ventilator fails any tests, remove it from clinical use. Do not use the ventilator until necessary

repairs are completed and the tests have passed.

 Before running function check, disconnect the patient from the equipment and ensure that a

backup ventilation mode is available for patient ventilation.

Two methods below are available to perform the function check.

 In the standby mode, select the 【Function check】 button.

 In the non-standby mode, enter the standby status by pressing the 【Standby】 membrane button

and then the knob to confirm, and select the 【Function check】 button.

After selecting the 【Function check】 button, the test process starts and the function check screen

displays, as shown below. Run the function check by referring to the description on the screen. This

screen displays the last function check time, function check items, test results, instructions and graphical

pictures about how to run the check. Select the 【Overview】 button to see more information about the

last function check.

Figure 4-1. Function check

43
System check items include:

1. Alarm signals

2. Blower

3. Inspiratory flow sensor

4. Stop valve

5. Safety valve

6. Pressure sensors

7. Expiration valve

8. Oxygen supply

9. Oxygen sensor

10. Leakage and compliance

11. Proximial flow sensor

After the function check has been completed, total results are listed below:

: this item successfully passes the test.

: this test results in a warning. You can skip the possible issues and operate the ventilator without
dealing with them. The table below lists the possible reasons for the three check items if the warning
icon appears.

Check items Possible cause

The oxygen supply pressure is between 190kPa and 280kPa or
Oxygen supply
exceeds 600kPa.
Oxygen sensor The oxygen supply pressure is not enough.

Leakage and compliance The leakage is from 200mL to 2L.

: this item fails. In this case, fix the issues and perform the check again until this item passes the
test.

: this icon appears if clicking 【Skip】 to skip this current check item during the check process.

Cancel: click this button to cancel the function check.

Redo: Run the function check again.

44
4.3 Alarm test

4.3.1 Pre-test preparations

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

2. Turn on the system switch.

3. Set parameters of the ventilator as below:

 Patient category: Adult

 Ventilation mode: A/C（V）

 Tidal volume: 450mL

 RR: 12 bpm

 Ti: 1.7s

 FiO2: 40%

 PEEP: 0

 Warn-up time: 5mins

4.3.2 Airway pressure high alarm

1. Press the 【System Setting】 membrane button to access system setting screen.

2. Select 【Alarm Setting】 and confirm.

3. Set the upper limit of PAW alarm less than or equal to the monitored value.

4. Make sure the 【Airway pressure high】appears in the alarm message display area.

5. Set the upper limit of PAW alarm larger than the monitored value.

6. Make sure the 【Airway pressure high】alarm disappears.

4.3.3 Tidal volume low alarm

1. Press the 【System Setting】 membrane button to access system setting screen.

2. Select 【Alarm Setting】 and confirm.

3. Set the lower limit of VTE alarm larger than or equal to the monitored value.

4. Make sure the 【Tidal Volume Low】appears in the alarm message display area.

5. Set the lower limit of VTE alarm less than the monitored value.

45
6. Make sure the 【Tidal Volume Low】alarm disappears.

4.3.4 O2 concentration low alarm

1. Press the 【System Setting】 membrane button to access system setting screen.

2. Select 【Alarm Setting】 and confirm.

3. Set the lower limit of FiO2 alarm more than the monitored value.

4. Make sure the 【O2 Concentration Low】appears in the alarm message display area.

5. Set the lower limit of FiO2 alarm less than or equal to the monitored value.

6. Make sure the 【O2 Concentration Low】 alarm disappears.

4.3.5 Circuit disconnected alarm

1. Pull out the breathing tubes.

2. Make sure the 【Circuit disconnected】 alarm appears in the alarm message display area.

3. Reconnect the breathing tubes.

4. Make sure the 【Circuit disconnected】 alarm disappears.

4.3.6 Battery in use alarm

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

2. Make sure the 【Battery in use】alarm appears in the alarm message display area.

3. Connect the AC power supply to the ventilator.

4. Make sure the 【Battery in use】alarm disappears.

4.3.7 Tube obstruction alarm

1. Disconnect the Y-piece tube from the test lung and plug the Y-piece tube with the leak test plug.

2. Verify that the 【Tube obstruction】 alarm is activated.

3. Connect the Y piece tube with the test lung and verify this alarm is reset automatically.

46
4.3.8 Tube partial occlusion alarm

1 Squeeze the inspiratory or expiratory breathing tube using your hand.

2 Verify that the 【Tube partial occlusion】 alarm is activated.

3 Release your hand and verify this alarm is reset automatically.

4.3.9 Oxygen supply pressure low alarm

1 Set FiO2 to more than 21%, for example 30%。

2 Connect the ventilator to the O2 supply.

3 Close the oxygen supply and check whether the 【Oxygen supply pressure low】 alarm is activated.

4.3.10 Continuous airway pressure high alarm

1. In A/C (P) mode, set the Pinsp value larger than 20cmH2O.

2. Press the 【Inspiratory Hold】 membrane button during inspiratory phase.

3. About 15 seconds later, make sure the 【High Continues Pressure】 alarm appears on the screen.

4. Press the 【Inspiratory Hold】 membrane button again.

5. Make sure the 【High Continues Pressure】alarm disappears.

4.3.11 Apnea alarm

1. Press the 【Ventilation Setting】 membrane button.

2. Set the ventilation mode “SPONT”, and do not press the test lung.

3. Make sure the 【Apnea】appears in the alarm message display area within the set apnea time.

4. Press the test lung to imitate trigger several times, make sure the 【Apnea】alarm appears.

47
5 Operations and Settings

5.1 Keys

Different colours of the keys indicate different status.

- Blue key (no border): indicates the normal status. You can select or active this key parameter

by using the knob or touching this key.

- Blue key (yellow border): indicates the selected status. You can adjust this key parameter by

using the knob or touching this key.

- Grey key (blue border): indicates the active status. When a key is selected, if pressing the knob,

a grey key with a blue border appears above. In this case, you can rotate the knob clockwise to

increase this key parameter, and counterclockwise to decrease the parameter, or touch “ ”

“ ” to change the parameter.

48
5.2 Boot self-test

Warnings:
 If abnormal alarms occur when the system starts up, do not use the equipment, contact the

authorized serviceman or the after service department of PRUNUS.

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

1. Connect the breathing tubes and test lung to the ventilator.

2. Plug AC power cord into the main AC outlet and make sure the power supply works normally.

3. Turn on the system switch on the rear of the ventilator. The system starts self-test and displays the

self-test screen.

If the failure occurs, the error information shows on the screen and the system stops running. Please

contact PRUNUS Technical Support if needed. The system goes to the standby screen until the

issue is fixed and self-test is passed.

5.3 Standby screen

The system enters the standby screen after the boot self-test is complete.

The standby screen is the first screen that can be operated by users. It‘s shown as below.

Figure 5-1. Standby screen

49
 In the standby screen, users can:

- Select the patient category: Adult, Pediatric, and Previous Patient.

- Set patient weight.

- Start ventilation to enter work mode.

- Perform function check.

Note:
 In the standby screen, only technical alarms can be activated, physiological alarm is invalid, but

it’s possible to edit the ventilation mode settings and system settings by pressing the

corresponding buttons.

5.4 Patient setting

In the standby screen, the users can choose to continue ventilation for the previous patient, or choose a

new patient category (adult or pediatric) to re-configure the ventilator settings.

1. Patient category setting

The following three categories can be set:

 Adult

 Pediatric

 Previous patient

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

parameters settings, which can be chosen by the user as a patient category when the system turns on

the next time.

If you choose “Previous Patient”, the ventilator will continue the ventilation according to the latest

settings.

If you choose the “Adult” or “Pediatric”, the ventilator will provide ventilation according to the default

settings.

In the standby screen, the default patient category is “Previous Patient”, and the ventilation mode is “A/C

(V)”, the “Start Ventilation” key is highlighted, rotate the knob to move the focus, and push the knob to
50
confirm setting.

2. Weight setting

You can set the patient’s weight in this screen. The system 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, the allowed range is:

- Adult: 20-150kg

- Pediatric: 5-20kg.

5.5 Standby

If needed, the system can be selected to the standby mode, in this mode, the system stops the

mechanical ventilation and monitored parameters function.

Press the 【Standby】 membrane button and confirm by pressing the knob to enter the standby mode.

It’s shown as below.

Figure 5-2. Standby screen

In the standby mode, the “Start Ventilation” key is highlighted, and the user can exit the standby

mode by pushing the knob. The user can also press the Mode Setting and System Setting buttons

to access the corresponding screens to change settings.

In standby mode, the following membrane buttons are disabled:

51
 - 【Freeze】

- 【Inspiratory Hold】

- 【Expiratory Hold】

- 【Extra Breath】

- 【100% O2 2 mins】

- 【Nebulizer】

5.6 Main screen

The Main screen provides the operator with displays of current mode of ventilation,
alarm status, battery charge status, monitored parameters, waveforms display and so on.
It’s shown as below. To switch between different screens, including waveform screen,
waveform + loop screen, big font screen, measured values screen and reference loop
screen, slide at the bottom of the screen.

Figure 5-3. Main screen-waveform

Three waveforms are available: Paw (Pressure-Time), Flow (Flow-Time), and Volume (Volume-Time).

Every waveform has two selectable abscissa time options: 11sec and 22sec. Use key “ ” to switch

between them. On the upper-left corner of the screen, it shows the current ventilation mode: A/C (V).

Touch it to access the Mode Setting screen.

52
Slide” ” to enter the next page, which displays both the wave and loop shown

as below.

Figure 5-4. Main screen - waveform + loop

The loop graphs will display on the right side of the screen. There are three loop options:

P-V(Pressure-Volume), F-P (Flow-Pressure), and F-V (Flow-Volume). As shown in the figure above,

touch P-V or F-P to switch between them.

Slide” ” to enter the next page, it displays the big font screen shown as

below.

Figure 5-5. Main screen-big font

Slide ” ” to enter the next page, it displays the measured values screen

53
shown as below.

Figure 5-6. Main screen-measured values

Slide” ” to enter the next page shown as below.

Figure 5-7. Main screen-reference loop

The ventilator system provides three loop options: P- V (Pressure -Volume), F-P (Flow-Pressure), and

F-V (Flow-Volume).

 Select the 【P-V】 button to switch between the loop options.

 Select the 【Reference loop】 button to save the current respiratory cycle loop as a reference loop.

 Select the【Capture】button to freeze the current respiratory cycle loop. In this case, rotate the knob

to move the cursor on the loop to view loop parameters.

 When both the 【Reference loop】 and 【Capture】 buttons are selected, two loops are displayed

on the screen. In this case, rotate the knob to move the cursor on these loops to view loop

parameters.

54
5.7 Mode setting

To access the Mode Setting screen press the 【Mode Setting】 membrane button or touch the current

ventilation mode name on the top-left corner of the main screen such as A/C(V), shown as below.

Figure 5-8. Mode Setting screen

In mode setting screen, the user can perform the following settings:

 Ventilation mode setting

 Parameters setting

 Backup ventilation setting

 Auxiliary settings

Note:
 The parameters setting of the ventilator is corresponding to the current ventilation mode. In other

words, when you select a ventilation mode, only the parameters associated with the current

ventilation mode will display on the screen.

1. Ventilation modes and parameters settings

Refer to the following procedures to set the ventilation modes and parameters:

1） To switch between different modes, directly touch the needed one or highlight the current mode

name using the knob, push the knob to confirm, and then move the focus to the required

ventilation mode and push the knob to confirm.

2） Touch or turn the knob to move the focus until the parameter to be set is highlighted, push the

knob, and then adjust the parameter by turning the knob, finally, push the knob to confirm

55
 settings.

3） Move the focus until the “Accept” key is highlighted, and then push the knob, the ventilator will

save your settings and exit the mode setting screen. When a ventilation mode is set, the mode

name will display on the top left of the screen.

The following ventilation modes are available:

Mode Names Description

A/C (V) Volume breath with Assist ventilation

A/C (P) Pressure breath with Assist ventilation

SIMV (V)+ PS Volume breath with SIMV

SIMV (P)+ PS Pressure breath with SIMV

SPONT Spontaneous breath

PRVC Pressure regulated volume control ventilation

CPAP Continuous Positive Airway Pressure

DualPAP Dual Positive Airway Pressure

2. Backup ventilation

The backup ventilation mode A/C (V) or A/C (P) is optional. Touch or turn the knob to move the focus

until the “Backup Mode” frame is highlighted, press the knob and then choose a backup mode in the

drop-down menu as shown below. For more information, see 2.9.8 Backup ventilation mode.

Figure 5-9. Mode Setting-Backup Mode screen

56
3. Auxiliary settings

In any mode, touch or highlight the Auxiliary settings and push the knob to display the Auxiliary settings
screen shown as below.

Figure 5-10. Auxiliary settings screen

In Auxiliary Settings screen, the user can set the following:

1) Sigh

Touch to select “Close” (Default) or “Open”. When this setting is Open, you can set Tinterval, PEEPint and

CYCLEsigh.

2) Nubulizer

Touch to select “10”, “20” or “30” in the drop-down menu.

3) Leak value

Touch to select the percent of the leak (Range: 20~80%, OFF). Default is 50%.

When the system leak occurs, for example: ( VTI - VTE）/VTI > set leak percent, 【System leakage】 alarm

is activated.

4) Leak compensation

Leak compensation range: Close, 20%~60%, Default is Close.

Touch to select “Close” or set the leak compensation percentage. The user set the percentage according

to the leak volume of the machine, and the maximum compensation volume is 60% of the setting tidal

volume.

57
5) Flow support

Touch to open or close the flow support function.

5.8 System settings

Press the 【System settings】 membrane button to access the system settings screen, shown as below.

Figure 5-11. System settings screen

The system settings screen contains the following items:

1) General settings

2) Alarm settings

3) System log

4) Biomed

5) Information

Touch or rotate the knob to move the focus to the selected item, and then push the knob to access it.

5.8.1 General settings

The General settings screen is shown as below.

58
 Figure 5-12. General settings screen

In General settings screen, the user can set the following:

 System Language: Chinese, English

 Day or night mode: Day, Night

 Datetime: Date, Time

 Waveform Selection: Wave1, Wave2

Set the above settings according to the following procedures:

1) Touch or rotate the knob to select or adjust the parameters, and then push the knob.

2) Selecting the “Close” key will save your settings and exit the screen.

5.8.2 Alarm setting

In this screen, users can adjust the alarm upper and lower limit parameters and alarm volume. The

parameters between the upper limits and the lower limits are the current monitored parameters. The

alarm setting screen is shown as below.

Figure 5-13. Alarm settings screen

59
To set the alarm limits:
1) Touch the alarm limit or rotate the knob to highlight the alarm limit and push the knob.

2) Rotate the knob to adjust the value.

3) Push the knob to confirm your settings.

To adjust the alarm volume, use the “Alarm Volume”. It has five levels, ranging from 20 to 100. Default is

80.

Touch “Default” to restore the upper and lower limit values to the default values.

Move the focus to select “Close”, and then press the knob, the system will save your settings and exit the

alarm settings screen.

5.8.3 System log

The System log screen provides the operator with previous alarm messages and setting, and it records

time and contents. Logs are stored in accordance with their generated time sequence.

Figure 5-14. System log screen

In the system log screen, when the “Close” is highlighted, you can touch or push the knob to exit this

screen.

Touch or rotate the knob to select the “Next Page ” or “Previous Page ” and push the

knob to view more logs.

Note:
 The ventilator can store up to 500 logs for your reference.

60
5.8.4 Biomed

The Biomed function is mainly used by trained engineers of Prunus to restore the system to its factory

defaults, calibrate, test or upgrade the system. To enter the Biomed screen, go to the Standby mode and

then the System Settings screen, touch 【Biomed】 button, then input password and touch 【OK】

button.

Figure 5-15. Biomed screen

Caution:
 We recommend that you perform system calibration when the ventilator is being connected to an

active AC power supply.

5.8.5 Version information

The information screen provides the software version information. It’s shown as below.

Figure 5-16. Version information

61
5.9 Power off the ventilator

When you finish operating the ventilator, perform the following procedures to power off the ventilator:

1. Press the 【Standby】 button and then the knob to enter the standby mode.

2. Disconnect the breathing tubes from the patient.

3. Switch the ventilator off with the system switch on the rear of the ventilator.

Note:
 If the ventilator is powered off when it’s not in standby mode, the alarm tones emits.

62
6. User Maintenance

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

when being dismantled and cleaned.

Cautions:
 Some parts of the equipment cannot be disposed in a normal way.

 Do not submerge the ventilator or pour cleaning liquids over, into or onto the ventilator.

 Do not disassemble the ventilator’s panel to avoid electric shock. Users should contact the

service technician of PRUNUS for maintenance work.

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

hospital regulations.

 After every disassembling, cleaning or reinstallation, it can be used regularly only after the check

described in chapter 4 pre-use check.

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

representative of PRUNUS complete all the necessary maintenance work whenever at possible

or accomplish the maintenance work by some qualified, trained and experienced staff.

 Use parts produced or sold by PRUNUS 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 the after-service department of PRUNUS.

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

about taking and disposing infectiousness materials. Because the way of cleaning, sterilizing in

the medical institutions is very different from the practice. Therefore PRUNUS cannot satisfy all

the special needs and cannot be responsible for cleaning, sterilizing or other hygienic measures

taken by the hospital during therapeutic process. We suggest that you use the effective methods

63
 already proven in this user manual, specific equipment and steps. Other methods may be just as

effectively, but we do not guarantee unless PRUNUS provides written authorization.

 When cleaning or sterilizing, 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 on the instrument and turn dry.

6.1 Cleaning and Disinfection

Warnings:
 Obey applicable safety precautions.

 Read the material safety data sheet for each cleaning agent.

 Read the operation and service instructions for all disinfection equipment.

 Wear gloves and safety glasses. A damaged O2 sensor can leak and cause burns (contains

potassium hydroxide).

 Reuse of undisinfected reusable accessories or components may cause cross-contamination.

 To prevent leaks, avoid damaging any component in case of disassembling and reassembling the

breathing system. Ensure the correct installation of the system. Make sure of the applicability and

correctness of the cleaning and disinfection methods.

 Disassemble and reassemble the breathing system as described in this chapter. If you need

further disassembly and reassembly, contact us. Improper disassembling and reassembling may

cause breathing system to leak and compromise normal system use.

 Seeping liquid into the control assembly can damage the equipment or cause personal injury.

When cleaning the housing, ensure that no liquid flows into the control assemblies and always

disconnect the equipment from the AC mains. Reconnect the AC mains after the cleaned parts

are fully dry.

64
 To avoid sticky residuals, do not use talc, zinc stearate, calcium carbonate, corn starch, or

equivalent materials. These materials can go into the patient's lungs and airways and cause

irritation or injury.

Cautions:
 To prevent patient exposure to disinfection agents and to prevent premature deterioration of

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

 To reduce the risk of electrical shock, disconnect electrical power from the ventilator before

cleaning and disinfection.

Note:
 Clean and disinfect the equipment as required before it is put into use for the first time. Refer to

this chapter for the cleaning and disinfection methods.

 To prevent damage, refer to the manufacturer's data if you have questions about a cleaning

agent.

 Do not use organic, halogenated, or petroleum based solvents, glass cleaners, acetone, or other

harsh cleaning agents.

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

 Keep all liquids away from electronic parts.

 Do not permit liquid to go into the equipment housings.

 Only parts marked 134°C can be autoclaved parts.

 Cleaning solutions must have a pH of 7.0 to 10.5.

 After cleaning and disinfection is completed, run Function check before using the equipment.

Use the equipment only when Function check is passed.

 After cleaning and disinfection is completed, check whether there is any damage to or cracks on

the components (e.g., expiratory valve membrane). If so, replace the component in a timely

manner.

65
 Parts marked 134°C are autoclavable. Recommended temperature is 134ºC. By using autoclave to

increase vapor pressure, the temperature also increases, rapidly solidifying bacterioprotein. The

disinfection effect of this method is fast and reliable.

Some of the ventilator’s parts can be cleaned and disinfected. Different parts of the ventilator should be

disinfected using different methods. You need to select the appropriate method to clean and disinfect the

parts based on the actual situations to avoid cross-contamination between the ventilator user and the

patient.

This table is our recommended cleaning and disinfection methods for the ventilator parts, including use

for the first time and use after many times.

Cleaning Disinfection
Recommended
D
Parts frequency ① ② A B C
Ultraviolet
Interval Wipe Immersion Wipe Immersion Autoclaving
radiation

Ventilator Housing

External ventilator

surface (including Each patient ① A or D

housing, power cord

Trolley and support arm Each patient ① A or D

Touch screen Each patient ① A or D

Every four
Bottom fan air intake
weeks/as ② B
dust filter
necessary*

Every four
Turbine air inlet dust
weeks/as ② B
filter
necessary*

Ventilator safety valve

Safety valve filter as necessary* ② B or C

66
 Cleaning Disinfection
Recommended
D
Parts frequency ① ② A B C
Ultraviolet
Interval Wipe Immersion Wipe Immersion Autoclaving
radiation

Ventilator expiration valve assembly

Expiration valve Each

② B or C
membrane (silicone) patient/weekly

Expiration valve
Each
assembly (except ② B or C
patient/weekly
membrane)

Ventilator patient tubing (reusable)

Patient tubing
Each
(including water trap, Y ② B
patient/weekly
piece and adapter)

Other

Each
Nebulizer Refer to the cleaning and disinfection methods provided by the nebulizer vendor.
patient/weekly

Each Refer to the cleaning and disinfection methods provided by the humidifier
Humidifier
patient/weekly vendor.

Cleaning Methods:

① Wipe: wipe with a damp cloth immersed in alkalescent detergent (soapy water, etc.) or alcohol solution, and then wipe off

the remaining detergent with a dry lint-free cloth.

② Immersion: flush with water first and then immerse it in alkalescent detergent (soapy water, etc., water temperature of 40ºC
recommended) for approximately three minutes. Finally, clean with water and dry completely.

Methods for Disinfection:

A: Wipe: wipe with a damp cloth immersed in medium- or high-efficiency detergent (ethanol, isopropanol, etc.) and

then wipe off the remaining detergent with a dry lint-free cloth.

B: Immersion: immerse it in medium- or high-efficiency detergent (ethanol, isopropanol, etc.) for more than 30 minutes

67
 Cleaning Disinfection
Recommended
D
Parts frequency ① ② A B C
Ultraviolet
Interval Wipe Immersion Wipe Immersion Autoclaving
radiation

(recommended time). Then clean with water and dry completely.

C: Steam autoclave at 134ºC for 10 to 20 minutes (recommended time).

D: Ultraviolet radiation for 30 to 60 minutes (recommended time).

As necessary*: shorten the cleaning and disinfection intervals if the equipment is used in dusty

environment to ensure that the equipment surface is not covered by dust.

The table below lists the cleaning and disinfecting agents and autoclaving process that may be used on

the ventilator.

Name Type
Ethanol (75%) Moderately efficient disinfectant

Isopropanol (70%) Moderately efficient disinfectant

Glutaraldehyde (2%) Highly efficient disinfectant
Ortho-Phthalaldehyde disinfectant (such as
Highly efficient disinfectant
Cidex®OPA）
Soapy water (pH value of 7.0 ~ 10.5) Rinsing agent

Clean water Rinsing agent

Steam autoclave* Highly efficient disinfection

Steam autoclave*: The recommended temperature of this disinfection method is 134ºC (273ºF).

6.2 Maintenance schedule

Maintenance Maintenance frequency
Expiratory valve, reusable
Every patient
breathing pipeline

Ventilator surface Every day

Turbine air inlet dust filter Every half year

Every year, or as necessary

Note:
 Replace the oxygen sensor if damaged. (see 3.2 Oxygen sensor for
Oxygen sensor
sensor installation procedures).
 Actual sensor life depends on operating environment. Operation at higher
temperature or O2 concentration levels will result in shorter sensor life.

68
 Maintenance Maintenance frequency
Check the parts for damage,
When cleaning and installing
replace or repair if necessary

6.3 Ventilator surface

1、 Using a damp cloth soaked in a cleanser (like 75% of medical alcohol) to wipe the ventilator surface.

2、 Using a dry lint-free cloth to clean the residual detergent on the surface.

Warning:
 Permeating liquid into the control assembly may damage the equipment or cause injury. Make

sure no liquid enters the control assembly and disconnect the equipment from AC power when

cleaning the equipment surface. Reconnect the AC power after all the parts are completely dry.

Caution:
 The touch screen can be cleaned with a dry, soft and lint-free cloth.

 If there is too much dirt on the surface, use ethylene glycol or isopropyl alcohol to clean it.

6.4 Exhalation valve

Figure 6-1. Exhalation valve disassembly view

1. Press “ ” button to unlock, and rotate the exhalation valve clockwise and pull out it by your
hands, and then take out the diaphragm.

2. Use a clean and soft cloth soaked in isopropyl alcohol to wipe the exposed surface of the exhalation

69
 valve, do not let liquid spatter into the exhalation valve openings.

3. Let the Y-piece and diaphragm soak for 30 minutes in chemical disinfectant (such as 2%

glutaraldehyde solution).

4. Take them out and soak for 30 minutes in clean water, and repeat twice.

5. Dry them with a soft cloth or natural wind.

Warnings:
 Do not clean the flow sensor with high-pressure air or a brush.

 Check the exhalation diaphragm before replacing it. If the diaphragm is damaged, replace it with

a new one.

6.5 Breathing tubes

Clean the breathing tubes with detergent or disinfectant for at least 10 minutes (recommended

temperature is 80℃), or use clean water or soft detergent (recommended water temperature is 40 ℃
),

and wipe them with 75% medical alcohol.

6.6 Battery

When the ventilator is connected to the AC power, the battery is charging. Do not allow the battery to

discharge completely as this may damage the ventilator.

If the battery indicator light does not illuminate when the ventilator is connected to the power supply,

check or replace the battery if necessary. Replacement of the internal battery should be accomplished

by trained technician of PRUNUS.

Warnings:
 The service life of lithium-ion battery is about 2 years. After its service life expires, please replace

a new one.

70
 Cautions:
 The battery can only be charged by this ventilator.

Note:
 Use the battery at least once every month to extend its lives. Charge the battery before it is

depleted.

 Inspect and replace battery regularly. Battery life depends on how frequent and how long battery

is used. For a properly maintained and stored lithium battery, its life expectancy is approximately 2

years. For improper use of the battery, life expectancy can be shortened.

 In case of battery failure, contact us or have your service personnel replace it. Do not replace the

battery without permission.

6.7 Oxygen sensor

To replace the oxygen sensor.

1. Refer to section 3.2 Oxygen sensor to assemble and disassemble the oxygen sensor.

2. Open the oxygen sensor package, and install the sealed ring into the sealed slot.

3. Turn the oxygen sensor clockwise to screw it in place, and plug in the oxygen sensor wire.

4. Close and fasten the oxygen sensor door.

Warnings:
 Some operations may cause danger to the patient, like replacing the O2 senor; therefore, you

should disconnect the ventilator from the patient.

 The exhausted O2 sensor should be replaced or disposed according to the local regulations.

 Check the O2 concentration value from set value and measured value, if value has a large

deviation, calibration is required only by the authorized serviceman of PRUNUS. If the problem

persists, O2 sensor is replaced.

 After O2 sensor is replaced, it needs to be calibrated only by the authorized serviceman of

PRUNUS.

71
6.8 Turbine air inlet dust filter

1. Refer to section 3.2 Oxygen sensor to disassemble the air inlet cover with turbine air inlet dust

filter.

2. Immerse the air inlet cover in the water and clean it.

3. Wipe off the remaining water with a dry lint-free cloth.

4. Install the air inlet cover and fasten it with a screw.

Figure 6-2. Turbine air inlet dust filter

72
Appendix A Working Principle

A.1 Pneumatic circuit principle

Boaray2000 is an electrically powered ventilator, the system consists of the O2 supply and

O2 control modules, air and O2 mixer module, turbine control inhalation module, exhalation

control module, nebulizer and patient system.

The modules figure is as shown below.

Appendix A-1 Gas modules diagram

1. O2 supply and O2 control modules

1） Connecting the pipeline or cylinder gas supply, to provide and control stable flow

of gas with the pressure of about 2.0bar. The pressure relief valve ensures safe

and stable gas pressure, to avoid injury caused by high gas pressure.

2） O2 flow control module——Using proportional valve to control flow and regulate

O2 concentration to meet the patient’s demand.

2. Air and O2 mixer module

1） Air filter.

2） Provide a chamber of the certain volume, to mix air and oxygen rapidly and

equably, and to detect the oxygen concentration of the mixing chamber.

3. Turbine control inhalation module

1） Noise less than 65dB.

2） Inhalation control valve.

4. Exhalation control module—Electrically powered exhalation switch.

73
5. Nebulizer module—Flow requirement: 7L/min.

6. Patient system—To achieve the purpose of mechanical ventilation.

A.2 Pneumatic Circuit Diagram

Appendix A-2. Pneumatic circuit diagram

Parts list is shown in the following table:

A1/A2/A3 Filter I1/I2 Check valve

B1 Pipeline pressure sensor B2/B3/B4 Pressure sensor

B5 O2 sensor C Pressure regulator

D1 Nebulizing valve D2 Proportional valve

D3 Water blowing valve D4 Electronic control safety valve

E1/E2 Air resistor F Mixer

G Electronic control stop valve H Turbine

M1/M2/M3 Flow sensor N Expiratory valve

74
Appendix B Product Specifications
This ventilator complies with the following standards.
 EN 60601-1/IEC60601-1 Medical electrical equipment Part I: General requirements for
safety
 EN 60601-1-2 Medical electrical equipment -Part1-2: General Requirements for
Safety- Collateral standard: Electromagnetic compatibility-Requirements and tests.
 EN ISO 80601-2-12 Medical electrical equipment Part 2: Particular requirements for
the safety and essential performance of anesthetic systems
 EN ISO 15223-1 Medical devices – Symbols to be used with medical device labels,
labeling and information to be supplied – Part 1: General requirements
 ISO 80601-2-55 Medical electrical equipment – Particular requirements for basic
safety and essential performance of respiratory gas monitors
 IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for
safety – Collateral standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical systems

B.1 System
General
Contents
information

Classification Ⅱb

ClassⅠ, containing internal power supply.

Electric shock
When you have queries about the integrality of the external protective grounded or
protection
the protective grounded cable, the equipment should be powered by the internal
classification
power supply(batteries).
Electric shock
Type B
protection grade
External
AC power supply: 100～240V, frequency: 50/60Hz.
power supply
Power supply Internal
lithium 11.1VDC, 12000 mAh.
battery
Gas supply Dry and clean compressed air, pressure: 0.28～0.6MPa.
Temperature: +10 ℃～+50 ℃
Operating Humidity: ≤95%, non-condensation
Atmospheric pressure: 50 kPa～106 kPa
Environment
Temperature: -20 ～+55 ℃
℃
Storage Humidity: ≤95%, non-condensation
Atmospheric: 50 kPa～106 kPa

75
B.2 Technical parameters
Parameters Description
Product weight 7.5 kg (Net weight)
Dimension 311 x 304 x 292 (W x H x D)
Category Electrically powered ventilator.
Display 8.4 inch TFT display.
120 minutes at least and up to 240 minutes when powered by a
Battery
fully-charged battery in the standard work state)
A/C(P), A/C(V), SIMV(P)+PS, SIMV(V)+PS, PRVC, SPONT, CPAP,
Ventilation mode
DualPAP
Waveform: Pressure-Time, Flow-Time, Volume-Time.
Graphics display
Loop: Pressure-Volume, Flow-Volume, Flow-Pressure.
Safety pressure of
≤125cmH2O
pneumatic circuit
Data communication
USB port, Ethernet port, RS232
interface
Sound pressure levels
≤ 65dB (A)
(Normal operation)

76
B.3 Setting parameters
Parameters Description Accurancy
Range: 20～2000mL（Boaray2000D）
Range: 50～2000mL（Boaray2000C） ±20mL, or ±15% of the
Tidal volume Increment: 20～100mL: 5mL set value, whichever is
100～1000mL: 10mL greater
1000~2000mL: 50mL
Respiratory rate Range: 4～100bpm, increment: 1bpm. ±2bpm or ±10% of the set

Range: 1～40, increment: 1bpm. value, whichever is

SIMVrate
greater
Inspiratory time Range: 0.2～10.0s, increment: 0.1s. ±0.1s or ±10% of the set
Range: 0～4s, increment: 0.1s. value, whichever is
Breath-hold time
greater
Range: 0.5～20L/min, increment: 0.5L/min. <5L/min: ±1 L/min, the
Flowrate tirgger
other is ±20%
Range: -20cmH2O～-1 cmH2O, increment: 1cmH2O. <-5 cmH2O: ±1 cmH2O,
Pressure trigger
the other is ±20%
Range: 0～40cmH2O（Boaray2000D）
PEEP Range: 0～30cmH2O（Boaray2000C）
±2cmH2O or ±10% of the
Increment: 1cmH2O
set value, whichever is
Pressure support Range: 5～70cmH2O, increment: 1cmH2O.
greater
Pressure control Range: 5～70cmH2O, increment: 1cmH2O.
Pressure limit Range:（PEEP+5）~80cmH2O, increment: 1cmH2O.
O2 concentration Range: 21～100%, increment: 1%. ±6%
Range: 10～60s, increment: 5s. ±1 s or ±10% of the set
Tapnea
value
Prate Range: 1～5, increment: 1.
Expiratory Range: 10～60%, increment: 10%.
sensitivity

77
B.4 Monitoring parameters
Parameters Description
Inspiratory tidal volume Range: 0～2500mL, Resolution: 1mL.
Expiratory tidal volume Range: 0～2500mL, Resolution: 1mL.
Minute ventilation volume Range: 0～50L, Resolution: 0.1L/min.
Spontaneous minute
Range: 0～50L, Resolution: 0.1L/min.
ventilation volume
Total respiratory rate Range: 0～100bpm, Resolution: 1bpm.
Spontaneous respiratory rate Range: 0～99bpm, Resolution: 1bpm.
I:E Range: 4:1～1:9, Resolution: 0.1.
PEEP Range: 0～40cmH2O, Resolution: 1cmH2O.
Airway peak pressure Range: 0～80cmH2O, Resolution: 1cmH2O.
Average airway pressure Range: 0～60cmH2O, Resolution: 1cmH2O.
Inspiratory plateau pressure Range: 0～60cmH2O, Resolution: 1cmH2O.
Minimum airway pressure Range: 0～40cmH2O, Resolution: 1cmH2O.
Oxygen concentration Range: 21～100%, Resolution: 1%.
Airway resistance Range: 0～150cmH2O/(L/s), Resolution: 1cmH2O/(L/s).
Compliance Range: 0～200mL/cmH2O, Resolution: 1mL/cmH2O.

78
B.5 Alarm setting parameters
Alarms Ranges
OFF, 10～1500mL
Increment: 10～100 mL: 10mL
Tidal volume Lower limit
100～500 mL: 20mL
500～1500 mL: 50mL
1～40 L/min, OFF
Upper limit
Minute ventilatin Increment: 1 L/min
volume OFF, 0～39 L/min
Lower limit
Increment: 1 L/min
21～100%
Upper limit
Increment: 1%
O2 concentration
OFF, 21～99%
Lower limit
Increment: 1%
1～80cmH2O
Upper limit
Increment: 1cmH2O
Airway pressure
0～40cmH2O
Lower limit
Increment: 1cmH2O
1～100bpm
Upper limit
Increment: 1bpm
Respiratory rate
0～99bpm
Lower limit
Increment: 1bpm

Upper limit /
O2 supply pressure
Lower limit 100 Kpa～750Kpa

PRVC airway pressure upper limits Plimit≤Ppeak+5cmH2O

It will generate an alarm when the airway pressure is continuous
Continues airway pressure high
above （PEEP+15）cmH2O for 15 seconds.
O2 supply pressure low O2 supply pressure is leas than 0.28MPa.
Battery in use This alarm lasts more than 120s.
Alarm auido paused time ≤100s

79
Appendix C Alarms

C.1 High priority alarms

Alarms Possible reasons Solutions
The apnea time exceeds the
pre-set value or alarm limit. Check the patient and breathing
Apnea The Interval between the two system.
continuous inhalation tries exceed Check the ventilation settings.
the set alarm limit.

The airway pressure exceeds the

upper limit of pre-set pressure.
The pipleline is twisted or blocked.
Airway pressure high
Mucus or secretion blocks the Check the patient and breathing
Note: If the airway pressure
endotracheal soft tube or airway system.
rises above the pre-set upper
pipeline. Check the ventilator settings
limit, the expiratory valve
Patient coughs or breathing rhythm and alarm limits.
opens.
is incompatible with the ventilator.
Improper alarm settings.
Expiratory filter is blocked.

The airway pressure is lower than

the pre-set lower limit of pressure. Check the patient and breathing
The tidal volume is set too low. system.
Airway pressure low
The pipeline falls off. Check the ventilation settings
Serious gas leakage. and alarm settings.
Improper alarm settings.
Check the patient and breathing
Airway pressure is continuous system.
Continuous airway pressure
above （ PEEP+15 cmH2O ） for Check the ventilator settings.
high
15(±3)seconds. Contact the after-service of
PRUNUS if problems remain.
O2 supply pressure is lower than Check the O2 supply pipeline.
Oxygen supply pressure low 280 kPa. Contact the after-service of
O2 supply pipeline disconnected. PRUNUS if problems remain.
Check and clean the patient
tubing.
Tube obstruction The breathing tube is occluded
Check and clean the expiration
valve.
The patient’s pipeline failures, or Clear the water in the pipeline
Circuit disconnected
the expiratory sensor probe and check the humidifier

80
 Alarms Possible reasons Solutions
failutes. settings.
The expiratory sensor Check the heating wire of the
disconnected. humidifier (if fitted).
The expiratory sensor probe is Check pipeline connections and
blocked. expiratory sensor probe
There is accumulated water in the connections.
sampling line of the expiratory
sensor probe.
Too much leakage.
Leak in the expiratory valve, Check the expiratory value,
System leakage expiratory breathing tube or the expiratory breathing tube or the
patient end. patient end.
Connected to the main power
supply. Plug in the charged
The battery power modules can battery modules.(connect the
Battery discharged
maintain less than 5 minutes ventilator to the power supply
and charge the battery
modules).
The measured O2 concentration is
lower than the pre-set value or
even lower.
Gas in the O2 supply pipeline is not
O2 concentration low Check the O2 supply pipeline.
O2.
O2 sensor failure.
O2 sensor not calibrated.
O2 module failure.
O2 sensor is not connected or O2 sensor is disconnected or
connect and replace O2 sensor.
failure invalid.
Inspiratory Pressure Sensor is
Inspiratory P_Sensor Failure Please calibrate or replace.
invalid.
Expiratory Pressure Sensor is
Expiratory P_Sensor Failure Please calibrate or replace.
invalid.
Please contact the after service
5V supply error 5V voltage error
dept. of PRUNUS.
Please contact the after service
12V supply error 12V voltage error
dept. of PRUNUS.
Please contact the after service
24V supply error 24V voltage error
dept. of PRUNUS.
Battery failure No battery in main unit. Please install the battery.

81
C.2 Medium priority alarms
Alarms Possible reasons Solutions
The minute volume exceeds the pre-set
Check patient and breathing system.
Minute ventilaton volume or default alarm limit.
Check the trigger sensitivity setting.
volume high The ventilator triggers
Check the alarm limit settings.
automatically.(auto-circle)
The minute ventilation volume exceeds the Check patient and breathing system.
pre-set vaule or default alarm limit. Check the pipeline outlet pressure.
Note: This alarm is also regarded as the check the patient breathing system
patient disconnection alarm. and do a leak test if necessary.
Minute ventilation
The patient’s spontaneous breathing Check the breath-hold time and
volume low
reduces. graphic display.
Leakage around the pipeline outlet. Considering use the ventilator to
Leakage in the patient breathing system. increase the patient’s respiratory
Improper alarm settings. support.
Check and clean the patient tubing.
Tube partial
The breathing tube is partially occluded Check and clean the expiration
occlusion
valve.
Low battery The battery modules can maintain for less Plug in the new battery modules or
capacity than 10 minutes connected to the main power supply.
The measured O2 concentration exceeds
the pre-set value or even higher.
The gas supply equipment is
O2 concentration disconnected.
Check the air supply equipment.
high The air module is disconnected.
The exhalation valve and safety valve will
open in the event of the gas supply
equipment failure.
1. The gas supply pressure is low, and
results in low tidal volume.
2. Pipeline leakage leads to low tidal Check the gas supply and pneumatic
volume. circuit. Contact the after-service
Tidal volume low
3. The inhalation valve failure and leads to dept. of PRUNUS if problems
low inspiratory tidal volume. remain.
4. The pneumatic circuit is blocked and
leads to low tidal volume.

82
C.3 Low priority alarms
Alarms Possible reasons Solutions
The respiratory frequency is too Check and take care of the patient.
high. Check the trigger settings.
Frequency high
Automatically triggering. Check the connection of the patient
Leakage of the pipeline. pipeline.
The respiratory frequency is too
Check and take care of the patient.
low.
Check the trigger settings.
Frequency low Improper trigger sensitivity
Check the inhalation termination
settings.
setting.
The tidal volume is high.
Please contact the after service dept. of
Power board error Power board error
PRUNUS.
The current system is powered Please connect to the external power
Battery in use
by battery. supply.

83
Appendix D EMC

Cautions:
 The ventilator meets the requirement of electromagnetic compatibility in EN

60601-1-2.

 The user needs to install and use according to electromagnetism compatibility

information which is attached with it.

 Portable and mobile RF communication devices may influence the ventilator’s

performance, so it should be kept away from them during using.

 Please refer to the below section of guidance of electromagnetism compatibility and

manufacturer’s declaration.

Warnings:
 The ventilator should not be used adjacent to or stacked with other equipment and

that if adjacent or stacked use is necessary, the ventilator should be observed to

verify normal operation in the configuration in which it will be used.

 Type A equipment is intended for use in the industrial environment, due to the

conduction and radiation disturbance of the ventilator. It is difficult to ensure the

electromagnetic compatibility while using in other environments.

84
Guidance and manufacturer’s declaration – electromagnetic emission –
for all EQUIPMENT AND SYSTEMS
1 Guidance and manufacturer’s declaration – electromagnetic emission
The ventilator is intended for use in the electromagnetic environment specified below. The
2
customer or the user of ventilator should assure that it is used in such an environment.

3 Emissions test Compliance Electromagnetic environment - guidance

RF emissions Group 1 The ventilator uses RF energy only for its internal

CISPR 11 function. Therefore, its RF emissions are very low

4
and are not likely to cause any interference in nearby

electronic equipment.

RF emissions Class A
5
CISPR 11

Harmonic emissions Class A

6
IEC 61000-3-2

Voltage fluctuations Complies

/
7
flicker emissions

IEC 61000-3-3

85
Guidance and manufacturer's declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic immunity
The ventilator is intended for use in the electromagnetic environment specified below. The

customer or the user of the ventilator should assure that it is used in such an environment.

Immunity test IEC 60601 Compliance level Electromagnetic

test level environment -

guidance

Electrostatic Floors should be wood,

discharge (ESD) ±8 kV contact ±8 kV contact concrete or ceramic tile.

If floors are covered

±15 kV air ±15 kV air
IEC 61000-4-2 with synthetic material,

the relative humidity

should be at least 30 %.

Electrostatic ± 2 kV for power ± 2 kV for power Mains power quality

transient / burst supply lines supply lines should be that of a

IEC 61000-4-4 ± 1 kV for ± 1 kV for typical commercial or

input/output input/output hospital environment.

lines lines

Surge ± 1 kV differential ± 1 kV differential Mains power quality

mode mode should be that of a

IEC 61000-4-5 ± 2 kV common ± 2 kV common typical commercial or

mode mode hospital environment.

Voltage dips, short < 5 % UT < 5 % UT Mains power quality

interruptions and (>95 % dip in UT ) (>95 % dip in UT ) should be that of a

voltage variations for 0,5 cycle for 0,5 cycle typical commercial or

on power supply 40 % UT 40 % UT hospital environment. If

input lines (60 % dip in UT ) (60 % dip in UT ) the user of the ventilator

for 5 cycles for 5 cycles requires continued

86
IEC 61000-4-11 70 % UT 70 % UT operation during power

(30 % dip in UT ) (30 % dip in UT ) mains interruptions, it is

for 25 cycles for 25 cycles recommended that the

< 5 % UT < 5 % UT ventilator be powered

(>95 % dip in UT ) (>95 % dip in UT ) from an uninterruptible

for 5 sec for 5 sec power supply or a

battery.

Power frequency 3 A/m 3 A/m Power frequency

(50/60 Hz) magnetic fields should

magnetic field be at levels

characteristic of a

IEC 61000-4-8 typical location in a

typical commercial or

hospital environment.

NOTE：UT is the a. c. mains voltage prior to application of the test level.

87
Guidance and manufacturer’s declaration – electromagnetic immunity
Guidance and manufacturer’s declaration – electromagnetic immunity

The ventilator is intended for use in the electromagnetic environment specified below. The

customer or the user of the ventilator should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance Electromagnetic

level environment - guidance

Conducted RF 3 Vrms 3 V (V1) Portable and mobile RF

IEC 61000-4-6 communications equipment

Radiated RF 150 kHz to 80 MHz should be used no closer to

IEC 61000-4-3 Outside ISM banda any part of the ventilator,

10V (V2) including cables, than the

10 Vrms recommended separation

distance calculated from the

150 kHz to 80 MHz equation applicable to the

In ISM banda frequency of the transmitter.

10 V/m 10 V/m (E1) Recommended

separation distance

80 MHz to 2.5 GHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

where p is the maximum

88
 output power rating of the

transmitter in watts (W)

according to the transmitter

manufacturer and d is the

recommended separation

distance in metres (m).b

Field strengths from fixed RF

transmitters, as determined

by an electromagnetic site

survey, a should be less than

the compliance level in each

frequency range. b

Interference may occur in the

vicinity of equipment marked

with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and

reflection from structures, objects and people.

a The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to

6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.

b The ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,5

GHz are intended to decrease the likelihood that mobile/portable communications equipment could

cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of

10/3 is used in calculating the recommended separation distance for transmitters in these frequency

ranges.

89
c Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones

and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be

predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF

transmitters, an electromagnetic site survey should be considered. If the measured field strength in the

location in which the ventilator is used exceeds the applicable RF compliance level above, the

ventilator should be observed to verify normal operation. If abnormal performance is observed,

additional measures may be necessary, such as reorienting or relocating the ventilator.

d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10V/m.

90
Recommended separation distances between portable and mobile RF
communications equipment and the EQUIPMENT or SYSTEM
Recommended separation distances between
portable and mobile RF communications equipment and the ventilator
The ventilator is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the ventilator can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the ventilator as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated 150 kHz to 80 150 kHz to 80 80 MHz to 800 800 MHz to 2.5
maximum MHz MHz MHz GHz
output of outside ISM bands
transmitter

W
0.01 0.035 0.12 0.012 0.023
0.1 0.11 0.38 0.038 0.073
1 0.35 1.2 0.12 0.23
10 1.1 3.8 0.38 0.73
100 3.5 12 1.2 2.3
For transmitters rated at a maximum output power not listed above the recommended
separation distance d in metres (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are
6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66
MHz to 40,70 MHz.
NOTE 3 An additional factor of 10/3 is used in calculating the recommended separation
distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the
frequency range 80 MHz to 2,5 GHz to decrease the likelihood that mobile/portable
communications equipment could cause interference if it is inadvertently brought into patient
areas.

NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

91
Appendix E Glossary and Symbols

E.1 Glossary

Abbreviation/Glossary Definition
A/C (V) Volume - Assist/control ventilation.
A/C (P) Pressure - Assist/control ventilation.
SIMV Synchronized intermittent mandatory ventilation.
Synchronized intermittent mandatory ventilation (Pressure
SIMV (P) + PS
control) + Pressure support
Synchronized intermittent mandatory ventilation (Volume
SIMV (V) + PS
control) + Pressure support
DualPAP Dual positive airway pressure
PRVC Pressure regulated volume control ventilation.
SPONT Spontaneous breath.
CPAP Continuous positive airway pressure
VT Tidal volume, unit:mL.
VTI Inspiratory tidal volume, unit:mL.
VTE Expiratory tidal volume, unit:mL.
MV Mechanical minute ventilaton volume, unit:L/min.
MVspn Spontaneous minute ventilaton volume, unit:L/min.
RR Respiratory rate, unit:bpm.
RRspn Spontaneous respiratory rate, unit:bpm.
SIMVrate SIMV respiratory frequency.
Ti Inspiratory time, unit:s.
TP Breath-hold time, unit:s.
Tapnea Apnea time, unit:s.
Prate Pressure slop rate.
I:E The ratio of inspiratory time to respiratory time.
Ftrig Flow trigger, unit: L/min or LPM.
Ptrig Pressure trigger, unit: cmH2O.
PEEP Positive expiration end pressure, unit: cmH2O.
Paw Airway pressure.
Psupp Pressure support, unnit: cmH2O.
Pinsp Inspiratory pressure, unit: cmH2O.
Phigh High pressure level, unit: cmH2O.
Plow Low pressure level, unit: cmH2O.
PShigh Support pressure of high pressure level, unit: cmH2O.

92
Abbreviation/Glossary Definition
PSlow Support pressure of low pressure level, unit: cmH2O.
Ppeak Airway peak pressure, unit: cmH2O.
Pmean Mean airway pressure, unit: cmH2O.
Pplat Inspiratory plateau pressure, unit: cmH2O.
Pmin Minimum airway pressure, unit: cmH2O.
ETS Expiratory sensitivity, unit: %.
FiO2 O2 concentration, unit: %.
R Airway resistance, unit: cmH2O/(L/s).
C Compliance, unit: mL/cmH2O.
Weight Weight, unit: kg.
kg Kilogram.
mL Milliliter.
L Litre.
bpm Bit per minute.
L/min or LPM Litre per minute.
min Minute
AC Alternating current.
cmH2O Centimeter water column.
Paw Pressure-Time waveform.
Flow Flow-Time waveform.
Volume Volume-Time waveform.
F-V Flow-Volume loop.
P-V Pressure - Volume loop.
F-P Flow-Pressure loop.
O2 Oxygen.
BTPS Body temperature and pressure-saturated.
ATPD Ambient temperature & Pressure dry.

93
E.2 Symbols

Consult instructions for use Alarm icon

Alarm silence icon Freeze button

Inspiratory hold button Expiratory hold button

Extra breath button 100% O2 2mins button

Nebulizer button Alarm silence button

Ventilation setting button System setting button

Waveform freeze
Standby button
countdown icon

Spontaneous breath icon Nebulization label

Previous patient Patient category (Adult)

Patient category (Pediatric) Battery charge icon

94
Flow sensor sampling line
AC indicator
label

Battery indicator Inspiratory label

Exhalation valve unlock

Expiratory label
label

O2 supply connector Oxygen sensor label

USB port Serial port

Ethernet interface Fuse

Date of manufacture Manufacturer

System switch label

Serial number
：On； ：Off

Authorized representative in the EUROPEAN COMMUNITY

This symbol indicates TYPE B equipment according to the EN60601-1 standard.

Equipotential terminals, used to connect the different parts of the equipment or

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

potential.

This symbol indicates protective ground. Connected to the external protective

grounded systems.

95
 The exhausted batteries should not be disposed in a normal way. In some areas,

there may be no recycle facilities

Proper disposal of products

E.3 Package symbols

THIS WAY UP FRAGILE

DO NOT ROLL KEEP AWAY FROM RAIN

KEEP AWAY FROM

STACK LIMIT BY NUMBER
SUNLIGHT

Note:
 Due to different configurations, some symbols may be not entirely consistent to the

equipment, please take the real equipment as valid.

96
Appendix F Default settings
The table below lists the default settings when the ventilator left the factory, user can reset

the parameters when necessary.

Power on default settings

Patient category Adult Pediatric

Ventilation mode A/C(V) A/C(V)

Ventilation parameters default settings

Parameter items Adult Pediatric

Ti (s) 1.7 0.7

VT (mL) 450 50

RR (bpm) 12 30

TP (s) 0 0

PEEP (cmH2O) 0 0

Psupp (cmH2O) PEEP+12 PEEP+6

Pinsp (cmH2O) PEEP+12 PEEP+6

FiO2 (%) 21 21

PTRIG (cmH2O) -3 -3

Prate 3 3

Tapnea (s) 20 20

Alarm default settings

VT (mL) Lower limit: OFF

Upper limit: Adult: 20/ Pediatric:10

MV (L)
Lower limit: Adult: 3/ Pediatric:1

Upper limit: 40
RR (bpm)
Lower limit: 0

FiO2 (%) Upper limit: 60

97
 Alarm default settings

Lower limit: OFF

Upper limit: Adult: 40/ Pediatric:20

Paw (cmH2O)
Lower limit: 0

Upper limit: /
Oxygen supply (kPa)
Lower limit: 280

Alarm volume 20

98