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Copyright

Version: A00

Revised on: 7, 2021

Declaration
Shenzhen Comen Medical Instruments Co., Ltd. (hereinafter referred to as Comen or Comen company) owns

the copyright of this non-public published maintenance manual and has the right to treat it as confidential

information. This Maintenance Manual serves as a reference material for maintenance and repair of Comen

products. No other person has the right to disclose the contents of this Maintenance Manual to others.

This Manual contains proprietary information protected by copyright law. All rights reserved. No part of this

Manual may be photocopied, reproduced or translated into any other language without Comen company’s

prior written consent.

The version number of this Maintenance Manual is subject to update at any time due to changes in software

or technical specifications without prior notice.

I
Foreword
This Maintenance Manual describes in detail the hardware composition, installation, disassembly, testing and

troubleshooting of this product and its related accessories, so that maintenance personnel can effectively deal

with common problems. This Maintenance Manual does not give an in-depth introduction to the product

structure and design principles. If you encounter problems that cannot be resolved, please contact our

After-sales Service Department.

This Maintenance Manual describes the product in the most complete configuration, and thus some of the

contents may not apply to the product you are maintaining. If you have any questions, please contact our

After-sales Service Department. Before carrying out product maintenance, please read this Maintenance

Manual carefully and make sure you fully understand its contents to ensure that you can carry out the

maintenance correctly and avoid product damage or personal injury.

Applicable users

This Maintenance Manual is suitable for professional biomedical engineers, authorized maintenance

personnel or after-sales service representatives who are responsible for maintaining this product.

Password

The password to enter the relevant settings of the ventilator is as follows:

n User maintenance: 5188

n Manufacturer maintenance: 1810

II
Table of Contents
Chapter 1 Safety ..................................................................................................................................... 1-1

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


Contraindications ............................................................................................................................................. 1-8
Equipment Symbols ......................................................................................................................................... 1-8

Chapter 2 Warranty Services ................................................................................................................ 2-1

Chapter 3 Working Principle................................................................................................................. 3-1

Gas Circuit Principle........................................................................................................................................ 3-1


Overview of gas circuit system ........................................................................................................ 3-1
Schematic diagram of gas circuit ..................................................................................................... 3-1
List of parts ............................................................................................................................... 3-2
Symbol definition...................................................................................................................... 3-3
Working principle of the gas circuit subsystem ............................................................................... 3-4
Gas source supply subsystem.................................................................................................... 3-4
Atomization subsystem ............................................................................................................. 3-6
Turbofan subsystem .................................................................................................................. 3-7
Flow regulation subsystem ....................................................................................................... 3-8
Inspiratory safety valve subsystem ........................................................................................... 3-9
Expiratory valve subsystem .................................................................................................... 3-12
Tubing set accessories ............................................................................................................. 3-14
Principle of Circuits ....................................................................................................................................... 3-15
Overview of the hardware board card ............................................................................................ 3-15
Power supply system ...................................................................................................................... 3-16
Output of the power supply system ........................................................................................ 3-16
Distribution of each circuit of power supply in the system .................................................... 3-17
Functional description of the board card ........................................................................................ 3-17
Power supply system board card............................................................................................. 3-17
Main control core board .......................................................................................................... 3-24
Monitoring system .................................................................................................................. 3-25
Display module ....................................................................................................................... 3-41

Chapter 4 Inspection and Test ............................................................................................................... 4-1

System Inspection ............................................................................................................................................ 4-1


Power Failure Alarm Test (External Power Supply and Buzzer) .................................................................... 4-1
O2 Gas Supply Pipeline Test ........................................................................................................................... 4-2
System Test ...................................................................................................................................................... 4-2
Autonomous Respiration Function Test ........................................................................................................... 4-3

III
Humidifier Performance Test ........................................................................................................................... 4-3
Alarm Test ........................................................................................................................................................ 4-4
Preparation before alarm test ........................................................................................................... 4-4
Battery in Use ................................................................................................................................... 4-4
Power Failure Alarm ........................................................................................................................ 4-4
Paw Too High ................................................................................................................................... 4-5
Paw Too Low ................................................................................................................................... 4-5
TVe Too Low .................................................................................................................................... 4-5
TVe Too High ................................................................................................................................... 4-5
MV Too Low .................................................................................................................................... 4-5
MV Too High ................................................................................................................................... 4-6
O2 Supply Failure ........................................................................................................................... 4-6
PEEP Too Low ............................................................................................................................... 4-6
Airway Obstructed ......................................................................................................................... 4-6
Tube Disconnected ......................................................................................................................... 4-7
Apnea Alarm................................................................................................................................... 4-7
FiO2 Too High ................................................................................................................................ 4-7
FiO2 Too Low ................................................................................................................................. 4-7
EtCO2 Too High ............................................................................................................................. 4-7
EtCO2 Too Low .............................................................................................................................. 4-8
SpO2 Too high ............................................................................................................................... 4-8
SpO2 too low .................................................................................................................................. 4-8
PR Too High ................................................................................................................................... 4-8
PR Too Low ................................................................................................................................... 4-9
Ventilator Function Test ................................................................................................................................... 4-9
Checking the standard operating state.............................................................................................. 4-9
Tidal volume inspection ................................................................................................................... 4-9
Trigger function inspection .............................................................................................................. 4-9
Autonomous respiration inspection in CPAP/PSV mode ................................................................. 4-9
Sidestream CO2 test ....................................................................................................................... 4-10
Mainstream CO2 test...................................................................................................................... 4-10
SpO2 test ........................................................................................................................................ 4-10
Special function inspection ............................................................................................................ 4-10
Electrical Safety Test ..................................................................................................................................... 4-11
Electrical safety inspection test ...................................................................................................... 4-12
Electrical safety checklist ............................................................................................................... 4-12

Chapter 5 Maintenance Menu and Software Upgrade ....................................................................... 5-1

User Maintenance ............................................................................................................................................ 5-1

IV
Overview .......................................................................................................................................... 5-1
User settings ..................................................................................................................................... 5-1
Default values................................................................................................................................... 5-2
Data transfer ..................................................................................................................................... 5-2
Export settings .......................................................................................................................... 5-2
Import settings .......................................................................................................................... 5-3
Data export ................................................................................................................................ 5-3
Interface settings .............................................................................................................................. 5-3
Nurse call .................................................................................................................................. 5-3
Network settings ....................................................................................................................... 5-4
System information .......................................................................................................................... 5-5
Version information................................................................................................................... 5-5
Configuration information ........................................................................................................ 5-5
Maintenance information .......................................................................................................... 5-5
Manufacturer Maintenance .............................................................................................................................. 5-5
Overview .......................................................................................................................................... 5-5
Manufacturer settings ....................................................................................................................... 5-6
Overview ................................................................................................................................... 5-6
Settings ...................................................................................................................................... 5-6
Function activation.................................................................................................................... 5-7
Restoring factory settings ......................................................................................................... 5-7
Version information................................................................................................................. 5-10
Manufacturer calibration ................................................................................................................ 5-10
Calibration data .............................................................................................................................. 5-11
Data monitoring ............................................................................................................................. 5-11
Diagnostic test ................................................................................................................................ 5-12
Event log ........................................................................................................................................ 5-13
Software upgrade and software function activation ....................................................................... 5-13
Upgrade of USB flash drive ........................................................................................................... 5-14
Description for the upgrade of USB flash drive ..................................................................... 5-14
Online upgrade of system software......................................................................................... 5-15
Online upgrade of VCM software........................................................................................... 5-15
Online upgrade of VPM software ........................................................................................... 5-15
Online upgrade of key board software .................................................................................... 5-15
Online upgrade of power panel ............................................................................................... 5-16
Common problems and countermeasures of software upgrade .............................................. 5-16
Function activation ....................................................................................................................... 5-18
Application for software function activation code ................................................................ 5-18
Software function configuration activation process ............................................................. 5-19

V
Common problems and countermeasures of software function activation ........................... 5-21
Function trial ................................................................................................................................ 5-22

Chapter 6 Maintenance and Calibration .............................................................................................. 6-1

Equipment Maintenance .................................................................................................................................. 6-1


One-year replacement parts.............................................................................................................. 6-1
Replacement parts ..................................................................................................................... 6-2
Ventilator inspection and test .................................................................................................... 6-3
Regular maintenance parts ............................................................................................................... 6-3
System Detection ............................................................................................................................................. 6-3
System self-test ................................................................................................................................ 6-4
Mechanical ventilation status detection ........................................................................................... 6-5
Volume control ventilation detection ........................................................................................ 6-6
Pressure control ventilation detection ....................................................................................... 6-6
Sensor zero point correctness detection ........................................................................................... 6-7
Flow sensor measurement accuracy detection ................................................................................. 6-8
Pressure sensor measurement accuracy detection ............................................................................ 6-9
System Calibration......................................................................................................................................... 6-11
Flow calibration (user) ................................................................................................................... 6-13
Flow calibration (manufacturer) .................................................................................................... 6-14
Operation steps of flow calibration (manufacturer) ................................................................ 6-15
Error codes and countermeasures of flow calibration function .............................................. 6-16
O2% calibration (user) ................................................................................................................... 6-17
O2% calibration (manufacturer) .................................................................................................... 6-17
Operation steps of O2 concentration calibration (manufacturer) ........................................... 6-18
Error codes and countermeasures of O2 concentration calibration ........................................ 6-18
CO2 zero calibration (user) ............................................................................................................ 6-18
Mainstream CO2 zero calibration ........................................................................................... 6-18
Sidestream CO2 zero calibration (user) .................................................................................. 6-19
Pressure and flow zero calibration (user) ....................................................................................... 6-19
Pressure and flow zero calibration (manufacturer) ........................................................................ 6-20
Operation steps of pressure and flow zero calibration ............................................................ 6-20
Pressure calibration (manufacturer) ............................................................................................... 6-21
Operation steps of pressure calibration (manufacturer) .......................................................... 6-21
Error codes and countermeasures of pressure calibration....................................................... 6-25
Expiratory valve calibration (manufacturer) .................................................................................. 6-26
Operation steps of expiratory valve calibration (manufacturer) ............................................. 6-26
Error codes and countermeasures of expiratory valve calibration .......................................... 6-27
Air-oxygen calibration (manufacturer)......................................................................................... 6-28

VI
Operation steps of air-oxygen calibration (manufacturer) .................................................... 6-28
Error codes and countermeasures of air-oxygen calibration ................................................. 6-30

Chapter 7 Troubleshooting .................................................................................................................... 7-1

Overview.......................................................................................................................................................... 7-1
System Self-test Failure Troubleshooting ........................................................................................................ 7-1
Technical Alarms and Diagnosis ...................................................................................................................... 7-3
Technical alarms of the main control board ..................................................................................... 7-4
Key board technical alarm ............................................................................................................... 7-4
Technical alarms of the monitoring board........................................................................................ 7-4
Auxiliary monitoring board technical alarm .................................................................................. 7-10
Power panel technical alarm .......................................................................................................... 7-10
Module technical alarm .................................................................................................................. 7-12
List of Fault Codes......................................................................................................................................... 7-14
Diagnostic Test............................................................................................................................................... 7-21
Operation before use of valve diagnostic tool................................................................................ 7-21
Correspondence between the valve diagnostic tool interface and the components ....................... 7-21
Correspondence with the gas circuit components ................................................................... 7-21
Correspondence with the hardware components .................................................................... 7-22
Troubleshooting methods for valve diagnostic tools ..................................................................... 7-23
Diagnosis of sensor zero point abnormality............................................................................ 7-23
Diagnosis of abnormal connection of sensor sampling tube .................................................. 7-24
Diagnosis of abnormal state of inspiratory valve or O2 proportional valve ........................... 7-25
Diagnosis of abnormal state of expiratory valve .................................................................... 7-26
Diagnosis of abnormal state of safety valve ........................................................................... 7-26
Gas Circuit System Failure ............................................................................................................................ 7-27
List of gas circuit failures ............................................................................................................... 7-27
Gas source supply subsystem ......................................................................................................... 7-30
The output pressure of the pressure regulating valve is inaccurate ........................................ 7-34
Atomization failure or abnormal flow rate.............................................................................. 7-36
The maximum flow output value of the high-pressure O2 branch is smaller ......................... 7-37
The flow measured value of the O2 flow sensor fluctuates greatly ........................................ 7-37
Turbofan subsystem and inspiratory flow regulating subsystem ................................................... 7-38
The maximum output flow is smaller ..................................................................................... 7-38
Inaccurate O2 concentration ................................................................................................... 7-39
Excessive leakage of the inspiratory valve ............................................................................. 7-39
The response time of the inspiratory valve is too slow ........................................................... 7-40
Inspiratory valve component .......................................................................................................... 7-41
Inspiratory valve leakage ........................................................................................................ 7-41

VII
The pressure relief speed of the pressure relief channel of the inspiratory valve is slow ....... 7-41
Expiratory valve component .......................................................................................................... 7-42
Expiratory valve leakage......................................................................................................... 7-42
Abnormal flow test of the expiratory valve ............................................................................ 7-43
The measurement error of O2 sensor is large................................................................................. 7-44
Hardware and Electrical System Failure ....................................................................................................... 7-44

Chapter 8 Maintenance and Disassembly ............................................................................................ 8-1

Preparation for Disassembly ............................................................................................................................ 8-1


VDisassembly tools .......................................................................................................................... 8-1
Preparations ...................................................................................................................................... 8-1
Disassembly of Maintenance Spare Parts ........................................................................................................ 8-1
Disassembling the lithium battery .................................................................................................... 8-1
Replacing the O2 battery .................................................................................................................. 8-2
Disassembling the high-efficiency filter and fan dust screen .......................................................... 8-3
Disassembling the expiratory valve diaphragm and expiratory check valve ................................... 8-4
Disassembling the sterilizable parts of the safety valve................................................................... 8-4
Disassembling the upper shell component ....................................................................................... 8-5
Disassembling the horn .................................................................................................................... 8-6
Disassembling the WIFI module ...................................................................................................... 8-6
Disassembling the SpO2 module ..................................................................................................... 8-7
Disassembling the display component ........................................................................................... 8-8
Disassembling the front shell of the main unit ............................................................................... 8-8
Disassembling the monitoring board card component ................................................................... 8-9
Disassembling the rear shell of the display and key control board ................................................ 8-9
Disassembling the alarm indicator board ..................................................................................... 8-10
Disassembling the display screen component .............................................................................. 8-10
Disassembling the shuttle board................................................................................................... 8-10
Replacing the pressure sensor filter ............................................................................................. 8-10
Disassembling the inspiratory valve seat component .................................................................. 8-11
Disassembling the electromagnet ................................................................................................. 8-11
Disassembling the air flow sensor................................................................................................ 8-11
Disassembling the sensor adapter board ...................................................................................... 8-12
Disassembling the O2 battery holder component ........................................................................ 8-13
Disassembling the kernel component........................................................................................... 8-13
Disassembling the AC-DC power panel ...................................................................................... 8-14
Disassembling the DC-DC power panel ...................................................................................... 8-15
Disassembling the fan .................................................................................................................. 8-15
Disassembling the AC power socket ............................................................................................ 8-16

VIII
Disassembling the DC input socket ............................................................................................. 8-17
Disassembling the expiratory valve seat component ................................................................... 8-17
Disassembling the voice coil motor of the expiratory valve ........................................................ 8-17
Disassembling the sidestream CO2 module (optional) ................................................................ 8-18
Disassembling the turbine box component .................................................................................. 8-18
Disassembling the expiratory valve component .......................................................................... 8-19
Disassembling the encapsulated filter mesh ................................................................................ 8-20
Disassembling the O2 inlet component........................................................................................ 8-20
Disassembling the proportional valve and atomization valve...................................................... 8-21
Disassembling the pressure regulating valve component ............................................................ 8-22
Disassembling the O2 flow sensor ............................................................................................... 8-22
Disassembling the low-pressure O2 connector ............................................................................ 8-23
Disassembling the battery adapter board ..................................................................................... 8-24
Disassembling the rear shell......................................................................................................... 8-24
Disassembling the mainstream CO2 + SpO2 connector component (optional) .......................... 8-24
Disassembling the WIFI antenna (optional)................................................................................. 8-25
Disassembling the sidestream CO2 + SpO2 connector (optional) ............................................... 8-25
Disassembling the trolley support platform component .............................................................. 8-26
Disassembling the trolley handle component .............................................................................. 8-26
Disassembling the trolley column ................................................................................................ 8-27
Disassembling the trolley chassis component .............................................................................. 8-27
Disassembling the humidifier fixing component ......................................................................... 8-27
Disassembling the trolley gas cylinder fixing component ........................................................... 8-28
Disassembling the trolley lock control component ...................................................................... 8-28

Chapter 9 Circuit and Gas Circuit Connection ................................................................................... 9-1

Gas Circuit Connection.................................................................................................................................... 9-1


Gas circuit connection diagram ........................................................................................................ 9-1
Gas circuit list .................................................................................................................................. 9-1
Circuit Connection ........................................................................................................................................... 9-3
Circuit connection diagram .............................................................................................................. 9-3
Circuit connection list ...................................................................................................................... 9-3

Chapter 10 Parts ................................................................................................................................... 10-1

O2 Inlet Components (NIST) ...................................................................................................................... 10-1


Explosive view ............................................................................................................................. 10-1
List of parts .................................................................................................................................. 10-1
O2 Inlet Components (DISS)....................................................................................................................... 10-2
Explosive view ............................................................................................................................. 10-2
List of parts .................................................................................................................................. 10-2

IX
Expiratory Valve Components ..................................................................................................................... 10-3
Explosive view ............................................................................................................................. 10-3
List of parts .................................................................................................................................. 10-3
Inspiratory Valve Components..................................................................................................................... 10-4
Explosive view ............................................................................................................................. 10-4
List of parts .................................................................................................................................. 10-4
Inspiratory Valve Seat Components ............................................................................................................. 10-5
Explosive view ............................................................................................................................. 10-5
List of parts .................................................................................................................................. 10-5
Quick Release Part for Inspiratory Valves ................................................................................................... 10-6
Explosive view ............................................................................................................................. 10-6
List of parts .................................................................................................................................. 10-6
Quick Release Components for Expiratory Valves...................................................................................... 10-7
Explosive view ............................................................................................................................. 10-7
List of parts .................................................................................................................................. 10-7
Turbine Box Components ............................................................................................................................ 10-8
Explosive view ............................................................................................................................. 10-8
List of parts .................................................................................................................................. 10-8
Low-pressure Proportional Control Valve Components .............................................................................. 10-9
Explosive view ............................................................................................................................. 10-9
List of parts .................................................................................................................................. 10-9
Trolley Components................................................................................................................................. 10-10
Explosive view ......................................................................................................................... 10-10
List of parts .............................................................................................................................. 10-10
Trolley Handle Components .................................................................................................................... 10-11
Explosive view ......................................................................................................................... 10-11
List of parts............................................................................................................................... 10-11
Trolley Support Platform Components .................................................................................................... 10-12
Explosive view ......................................................................................................................... 10-12
List of parts .............................................................................................................................. 10-12
Trolley Chassis Components ................................................................................................................... 10-13
Explosive view ......................................................................................................................... 10-13
List of parts .............................................................................................................................. 10-13
Trolley Gas Cylinder Fixing Components ............................................................................................... 10-14
Explosive view ......................................................................................................................... 10-14
List of parts .............................................................................................................................. 10-14

Appendix I Preventive Maintenance Report of Comen V3/V3A Ventilator.................................... 10-1

X
Chapter 1 Safety
This product does not involve information on hazard levels.

Safety Information

Danger

l It indicates an imminent danger that, if not avoided, may result in death, serious personal

injury or property damage.

Warning

l It reminds you that there may be serious consequences, adverse events or situations that

endanger safety. Failure to follow the warning will result in serious personal injury or death to

the user or patient.

Caution

l It indicates a potentially dangerous or unsafe operation that, if not avoided, may cause minor

personal injury, product failure or damage or property loss. It may also cause more serious

injuries in the future.

Attention

l It emphasizes important precautions, provides instructions or explanations to better use the

product.

WARNING

l This product can be used only by trained, qualified medical staff. Any unauthorized personnel

or personnel without training shall not perform any operations. The equipment must be

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Safety

operated strictly in accordance with this manual.

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

operation.

l The equipment cannot be used with inflammable anesthetic gas mixed with air, oxygen or

nitrous oxide

l To prevent damage to the ventilator, the ventilator is only connected to clean and dry medical

oxygen (≥99.5%).

l The ventilator can not be connected to oxygen 93, the accuracy of the O2 monitoring is not

maintained when used with Oxygen 93, it shall not be used with gas supplied from oxygen

concentrators.

l Do not place the power plug used to disconnect the device from supply mains in a position not

easily accessible by the operator.

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

be overheated

l Do not cover the ventilator or place in a position that affects proper operation, not block the gas

intake port or emergency intake port, thereby interfering with patient ventilation..

l Do not open the housing of the device to avoid the potential risk of electric shock. The ventilator

must be maintained and upgraded by service personnel having been trained and authorized by

Comen.

l Alarm volume and upper and lower alarm limits should be set depending on the patient. Do not

monitor the patient relying on the sound alarm system. If the alarm volume is set too low, it

may further endanger the patient. The most reliable monitoring method is to pay close

attention to the patient’s actual clinical condition.

l The physiological waveforms, parameters, alarms and other information displayed on the

screen of the equipment are only for reference by doctors, which shall not be used as a basis for

clinical treatment.

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

using.

l The settings under maintenance menu can be modified only after disconnecting the patient

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Safety

from the equipment.

l Positive pressure breathing may be accompanied by the following side effects: barotrauma,

hypoventilation, hyperventilation and other hazards.

l To avoid the risk of electric shock, this equipment must only be connected to a supply main

with protective earth. If the power socket is not connected to an earth conductor or there is any

doubt about the completeness of wiring, please use the rechargeable battery to supply voltage to

the device instead of using this socket

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

l Please observe the local regulations or the hospital’s waste disposal policy when disposing of

packaging materials. Keep the packaging materials out of the reach of pediatric.

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

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

patient.

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

not use other devices near or together with the ventilator. If it is necessary to use other devices

near or together with the ventilator, please verify that the ventilator can work normally in the

setting state when other devices are used.

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

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

conductive mask or breathing tube.

l Please carefully place the power cord and the cables of various accessories to prevent the

patient from getting wound or suffocated, entanglement of the cables, or electrical interference.

l If the monitoring system inside the equipment malfunctions, there must be an alternative

scheme to ensure monitoring of sufficient level. Under all circumstances, the ventilator operator

must be responsible for proper ventilation and safety of the patient.

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

is detected in the ventilator, disconnect the patient from it and immediately start ventilation

with such a device. For example, using a manual respirator.

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

equipment is applied to the patient. If the equipment you are using is not provided with this

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Safety

function or the function is disabled, please use a monitor compliant with ISO 80601-2-55) to

monitor oxygen concentration.

l The ventilator shall not be used in a hyperbaric chamber. Such use might cause the ventilator

to not function correctly, causing patient death or serious deterioration of health.

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

l The ventilator shall not be used with nitric oxide. Such use might cause the ventilator to not

function correctly, causing patient death or serious deterioration of health.

l When using nebulization or humidification, breathing system filters and heat and moisture

exchangers can require more frequent replacement to prevent increased resistance and

blockage.

l The ventilator accuracy can be affected by the gas added to the ventilator breathing system by

use of a pneumatic nebulizer.

l For non-invasive ventilation, the tidal volume actually exhaled by the patient will be different

from the monitored value from the ventilator due to the leakage around the mask.

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

hazardous substances entering the patient circuit.

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

compliance with their IEC standards (e.g. IEC 60950-1 information technology

equipment-safety and IEC 60601-1 medical electrical equipment –safety). Anyone connecting

additional equipment to the signal input port or the signal output port configures a medical

system, and, therefore, is responsible that the system complies with the requirements of the ME

system according to IEC 60601-1. If in doubt, please contact our company.

l When the port is connected with patient or when replacing the O2 sensor, do not touch the

signal I/O port, otherwise the patient may get injured.

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

l When the patient cable port, network port and other signal ports connected to multiple

equipment, the total leak current caused shall conform to IEC60601-1.

l This equipment cannot be used in a MRI environment.

l When the gas input system of the ventilator malfunctions or becomes abnormal, please contact

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Safety

the manufacturer to repair the system by designated personnel.

l When passing the ventilator through an obstacle (e.g., threshold), please carefully move the

ventilator to avoid damage caused by toppling over.

l Before moving the ventilator, please remove the supporting arm to prevent the ventilator from

toppling over.

l When stop moving the ventilator, please press down the brake pedal to avoid damage caused by

accidental movement of the ventilator.

l To avoid personal injury or equipment damage, please ensure that the ventilator has been

secured to a trolley or placed on a safe and steady platform.

l To prevent the patient from the harm caused by equipment, when the [Technical Error **] or

[Device Failure **] alarm is triggered, please remove the equipment immediately, record the

failure code and contact our After-sales Service Department.

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

l The blower fan will cause the gas being heated. Please ensure the pipe length from humidifier

to the Y-pipe greater than 1.2 m, so as to reduce the gas temperature in pipe and prevent the

patient from being injured.

l When the buzzer alarms, please stop using the ventilator immediately and contact our

After-sales Service Department.

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

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

l Defibrillation energy has no effect on the applied parts of the ventilator.

l Always have immediate access to an alternative means of ventilation, which is ready for use, in order

to reduce the possibility of patient death or serious deterioration of health.

l The ventilator shall not be used with inlet gases, which are not specified for use (e.g. helium or

mixtures with helium). Such use might cause the ventilator to not function correctly, causing patient

death or serious deterioration of health.

l It is the responsibility of the responsible organization to ensure that the oxygen source is compatible

with the rated range of pressure, flow rate and oxygen concentration as marked on the ventilator

and indicated in the instructions for use as this can affect the performance of the ventilator that can

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Safety

consequently result in patient death or serious deterioration of health.

l To avoid contaminating or infecting personnel, the environment, or other equipment, make sure you

disinfect and decontaminate the device and any appropriate accessories prior to disposal.

CAUTION

l The ventilator is suitable for use in patient environments.

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

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

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

gastrectasia.

l When Ppeak is greater than 33cmH2O, the risk of gaseous distention can be increased. At the

moment, invasive ventilation shall be considered to use.

l Once the ventilator is connected to the patient, there should always be a appointed one to

watch and monitor the operation status of the equipment.

l During the ventilator running, do not dismantle the inspiratory valve component and the

expiratory valve component unless the ventilator is in standby.

l Electromagnetic field may affect the performance of the equipment. Therefore, other devices

used near the equipment shall conform to the applicable EMC requirements. Mobile phones or

X-ray are all potential sources of interference since they all transmit high-intensity

electromagnetic radiation.

l This system can work normally under the anti-interference level identified in this User Manual.

If the interference level is higher than this level, an alarm could be triggered, and mechanical

ventilation may stop. Take care to avoid false alarms of the system caused by high-intensity

electric field.

l To reduce the risk of fire, do not use any gas hose component that is worn or contaminated by

combustible material (e.g., oil, grease).

l To reduce the risk of fire, only use hoses that are approved for medical purposes for connecting

the oxygen source to the ventilator.

l To reduce the risk of fire, please cut off the oxygen source when the ventilator is not in

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Safety

ventilation state.

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

l To avoid equipment damage and ensure patient safety, please use accessories specified in this

User Manual.

l Clinicians are responsible for correct setting of the ventilator.

l Before using the ventilator or when deviation exists in the measured value, please calibrate the

flow sensor.

l A fan failure may cause an increase in the oxygen concentration inside the device, which may

cause in a fire or explosive hazard.

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

l To avoid the risk of fire, only use the specified fuses or fuses having the same type, rated

voltage and rated current as the existing fuses. To replace fuses, please contact our After-Sales

Service Department.

l To avoid patient injury, please select the correct patient type, set the ventilation parameters

correctly and connect the proper breathing tube. Before the ventilator is applied to each patient,

please ensure that the system check result is OK.

l To ensure the accuracy of oxygen concentration monitoring, please replace the damaged

oxygen sensor in time, or use an external monitor conforming to the requirements of ISO

80601-2-55.

l Please properly install or relocate the equipment to avoid damage due to drop, collision, strong

oscillation or other external mechanical forces.

l Before moving the ventilator, please ensure that the casters and brake pedals work normally

and that the main unit of ventilator has been locked onto the trolley.

l Before powering on the device, please confirm that the supply voltage and frequency conform

to the requirements specified on the device nameplate or in this manual.

l To achieve electrical isolation between the ventilator and input power, please disconnect the

power plug of the ventilator.

l Avoid long-term storage of the ventilator in an environment over 50℃. Such environment could

damage the internal battery and oxygen sensor or reduce the battery life.

1-7
Safety

l When the useful life of the equipment or its accessories or medical waste is in expiry, please

dispose of in accordance with the local regulations or the hospital’s rules.

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

l Use the original package to transport the ventilator.

Note

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

l This manual introduces the product of the most complete configurations. Some configurations

or functions may not be available on the product you have purchased.

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

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

l The software contained in this equipment has been developed in accordance with the

requirements of IEC62034 to minimize the probability of risks caused by program error.

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

Contraindications

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

Equipment Symbols

Environment-friendly use
Caution period of electronic
information products
Defibrillation-proof Type CF Defibrillation-proof Type BF
applied part applied part

AC/DC power Battery

Power switch Alarm audio paused

Lock Unlock

1-8
Safety

Equipotentiality Fuse

High-pressure oxygen supply Low-pressure oxygen supply


connector connector

Direct current input port Ventilator gas outlet

Nebulizer connector Oxygen sensor connector

Inspiratory connector Expiratory connector

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


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

Date of manufacture Manufacturer

Follow Instruction For Use Nurse call connector

VGA connector Network connector

Separate collection of WEEE USB connector

Equipment weight Safe working load

This way up Stacking layer limit

Fragile, handle with care Keep dry

Temperature limit Atmospheric pressure limit

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

Adult(Male) Pediatric(Male)

Adult(Female) Pediatric(Female)

1-9
Safety

Invasive ventilation Non-invasive ventilation

Alarm setup Setup

Tools key Freeze key

History Inspiratory trigger

O2↑key Screenshot

Alarm off Nebulizer

Recent alarm Standby key

Open state Off state

O2 Sensor installation
Clear alarm
instruction

High Efficiency Particle Air


/ /
(HEPA) installation instruction

1-10
Chapter 2 Warranty Services

The warranty period of the purchased product is subject to the sales contract.
Consumables: Refer to disposable consumable materials that need to be replaced after each use or fragile
materials that need to be replaced regularly. There is no warranty for consumables.
The warranty period starts from the “installation date” filled in the Equipment Warranty Card attached to the
product. The Equipment Warranty Card is the only certificate for calculating the warranty period. In order to
protect your rights and interests, please fill in the warranty card after the equipment is installed, and deliver
the second copy of the warranty card (“Comen retention” copy) to the installer or mail it back to the Comen’s
User Service Department.
Please note that the following conditions will not be covered by the warranty:
1) The customer fails to fill in and return the equipment warranty card within 30 days after the installation
acceptance is completed;
2) The equipment serial number provided by the customer is incorrect (our company confirms the warranty
with the equipment serial number).
During the warranty period, the products can enjoy free after-sales services; but please note that even if the
product needs to be maintained due to the following reasons during the warranty period, Comen will
implement a fee-based maintenance service, and you will need to pay for the maintenance and accessories:
n man-made damage;
n misuse;
n the voltage of the power grid exceeds the specified range of the product;
n irresistible natural disasters;
n replace or use parts and accessories not approved by Comen or be maintained by non-Comen authorized
personnel; and
n other faults not caused by the product itself.
The use of reagents and other consumables that are not approved by Comen causes the instrument to
malfunction, and it is not within the scope of the maintenance service provided by Comen.
After the warranty period expires, Comen can continue to provide chargeable maintenance services. Users
need to bear the freight (including customs fees) for the products shipped to the Comen company for
maintenance.
If you do not pay or delay in paying the fee for maintenance services, Comen will temporarily suspend the
maintenance services until you pay.

Return
If you really need to return the goods to the Comen company, please follow the steps below:
Obtaining the right of return: Contact the After-sales Service Department of the Comen company and inform
the instrument number of the Comen product. This number has been marked on the equipment nameplate. If
the instrument number is not clearly identifiable, returns will not be accepted. Please also indicate the
instrument number, production date, and briefly describe the reason for return.
2-1
Chapter 3 Working Principle

Gas Circuit Principle

Overview of gas circuit system

The gas circuit system mainly includes a gas supply subsystem, an atomization subsystem, a turbofan
subsystem, a flow regulation subsystem, an inspiratory safety valve subsystem, an expiratory valve subsystem,
and a patient RESP circuit system.

Flow regulation Inspiratory safety valve


Turbofan subsystem
subsystem subsystem

Patient RESP circuit


Gas source supply Expiratory valve
subsystem subsystem

Atomization
subsystem

As shown in the figure above, the patient RESP circuit is a bridge connecting the inspiratory safety valve
subsystem and the expiratory valve subsystem. At the same time, the gas source supply subsystem and the
atomization subsystem can also be connected with the patient RESP circuit to realize the atomization function.
These several systems together form a closed circuit to realize the ventilation management function of the
ventilator.

Schematic diagram of gas circuit

3-1
Working Principle

List of parts

Symbol Name Function and index


Low AIR Low-pressure air Air inlet
source
Low-pressure O2 Low-pressure O2 interface, quick plug connector, compatible with
Low O2
source (CPC) PMC series, and gas source pressure ≤ 100 kPa
High O2 High-pressure O2 High-pressure O2 interface, NIST/DISS is optional, and the gas
source source pressure is 280-600 kPa
F1 Anti-dust filter mesh Filter air source dust and other impurities
F2 HEPA filter Filter air source bacteria and viruses
Pfilter Negative pressure Monitor the negative pressure of the air inlet
sensor
CV1 Check valve When the low-pressure O2 is not connected, cut off the connection
between the low-pressure O2 branch of the gas system and the
outside
F3 Filter Filter impurities in high-pressure O2
REG Pressure regulating Reduce and stabilize the high-pressure O2 source pressure to 220
valve kPa ± 30 kPa
PSOL Solenoid proportional High-pressure O2 proportional valve, output peak flow rate ≥ 120
valve L/min@600 kPa
Q1 Flow sensor Monitor the O2 flow
F4 Filter mesh For steady gas flow
Mixing Box First-level hybrid Air-oxygen mixing channel and reduce the front-end noise of the
noise reduction cavity turbofan subsystem
Blower Turbofan Complete the mixing of air and O2 and increase the pressure of the
mixed gas to a preset value
R1 Atomization Limit the output flow rate of the atomization branch
air-resistor
NCV Atomization valve Control the on and off of the atomization branch
Blower.P Turbine pressure Monitor the turbine output pressure
sensor
SOL1 Three-way valve for Complete the switching function of turbine pressure measurement
zero calibration and zero calibration
F5 Filter Three-way valve for zero calibration for protecting turbine pressure
F6 Filter Protect the upstream branch from pollution of exhaled air
R2 Flushing air-resistor Limit the flushing gas circuit flow
Insp. valve Inspiratory valve Control the flow of the inspiratory branch

3-2
Working Principle

F7 Filter mesh For steady gas flow


OS O2 concentration Monitor the O2 concentration
sensor
Q2 Gas mixture flow Monitor the gas mixture flow
sensor
SOL2 Three-way valve for Downstream pressure zero calibration function of the diaphragm of
pressure zero the expiratory flow sensor
calibration
SOL3 Three-way valve for Zero calibration of the expiratory pressure sensor and upstream
pressure zero pressure zero calibration function of the diaphragm of the
calibration expiratory flow sensor
SOL4 Three-way valve for Complete the switching function of inspiratory pressure
zero calibration of measurement and zero calibration
inspiratory pressure
Pflow Expiratory pressure Monitor the upstream and downstream pressure of the diaphragm
difference sensor
Exp.P Expiratory pressure Monitor the pressure of the expiratory branch
sensor
Insp.P Inspiratory pressure Monitor the pressure of the inspiratory branch
sensor
CV2 Inspiratory check Prevent the reverse flow of gas
valve
CV3 Autonomous Autonomous inspiratory channel
inspiratory valve
SV Safety valve Pressure relief protection
Q3 Expiratory flow Monitor the flow of exhaled air
sensor
Exp.Valve Expiratory valve Through the voice coil motor control system PEEP or Plimit
CV4 Expiratory check Ensure the one-way flow of gas
valve

Symbol definition

Symbol Name Symbol Name

Gas source Filter

On-off valve (two-position


Pressure regulating valve
two-way solenoid valve)

O2 sensor Pressure sensor

3-3
Working Principle

Check valve Air-resistor

Two-position three-way solenoid


Solenoid proportional valve
valve

Air-oxygen mixing chamber Turbofan

Inspiratory valve Flow sensor

Working principle of the gas circuit subsystem

The gas circuit system of the ventilator can be decomposed into seven parts as shown in the following figure
according to the structural composition and function: gas supply subsystem, atomization subsystem, turbofan
subsystem, flow regulation subsystem, inspiratory safety valve subsystem, patient RESP circuit, and
expiratory valve subsystem.

Gas circuit system

Inspiratory Expiratory
branch Patient RESP circuit branch

Fl
ow
reg
Gas u la Ins pi ra to
Turbof Atomi zat Ex p irat
so urc e ti o ry safet y
an ion ory
suppl y n v al ve
su bsy st su bsy st e val ve
su bsy st su subsyst e
em m subsyst
em bs m
yst em
em

Gas source supply subsystem

The following figure shows the schematic diagram of the gas source supply subsystem. The gas source supply
subsystem includes three branches of high-pressure O2, low-pressure O2 and low-pressure air. The indoor air
enters the overall unit after passing through the anti-dust filter mesh F1 and HEPA filter F2; O2 enters the
overall unit through the high-pressure O2 branch or the low-pressure O2 branch; a flow sensor Q1 is installed
at the confluence outlet of low-pressure O2 and high-pressure O2 to monitor the O2 flow into the overall unit.

3-4
Working Principle

The gas source supply subsystem is the initial part of the ventilator’s gas circuit, and its main function is to
introduce external O2 and indoor air into the overall unit. Since the indoor air contains dust and impurities, an
anti-dust filter mesh is required at the air inlet. At the same time, in order to filter the bacteria and viruses in
the indoor air, a HEPA filter is installed at the air inlet to filter bacteria and viruses to ensure that the air
entering the overall unit is clean and free of bacteria. When the machine is used or left for a certain period of
time, the surface of the anti-dust filter mesh and HEPA filter at the air inlet may absorb dust or impurities.
When dust or impurities accumulate to a certain extent, the air inlet will be blocked to a certain extent, which
may result in insufficient air intake into the overall unit. By setting a negative pressure sensor Pfilter at the air
inlet, it can effectively monitor whether the air inlet is blocked. If the air inlet is blocked and the air source
pressure is too low, the negative pressure sensor Pfilter will generate an alarm to remind the user to replace the
HEPA filter.
The following is the location of the air inlet and the component diagram of the HEPA filter:

HEPA filter

The high-pressure O2 inlet connector is designed as optional NIST or DISS according to the standard
requirements to prevent misplugging; low-pressure O2 is designed as a quick-plug connector, which is
compatible with (CPC) PMC series, and has a gas circuit cut-off function to prevent cross-air between
high-pressure O2 and low-pressure O2 in the ventilator; air enters the overall unit after passing through the
anti-dust filter mesh and the HEPA filter, in turn; there are no standard and regulatory requirements for the
interface form, and it is designed as a non-standard interface form. The pressure regulating valve of the
high-pressure O2 branch reduces and stabilizes the gas source pressure to 220 kPa ± 30 kPa to ensure that the
output of the solenoid proportional valve PSOL at the rear end is stable and has good repeatability.
The following figure shows the interface diagram of the high-pressure O2 source inlet component:

3-5
Working Principle

O2
proportional
valve

High-pressure O2
connector,
Atomization
compatible with
valve
NIST/DISS

Low-pressure O2
quick-plug
connector

O2 flow sensor

Pressure regulating Atomization


valve outlet

Atomization subsystem

The atomization control subsystem mainly realizes the on and off of the atomization airflow through the on
and off of the atomization valve NCV, and then realizes the control of the atomization airflow on the atomizer
(the atomizer needs to be equipped separately, independent of the main unit of the ventilator). When using the
atomization function, please note that the atomization subsystem can only be used when the system is
connected to a high-pressure O2 source. To use this function, please check whether the machine has been
connected to a high-pressure O2 source.
The gas circuit plan of the atomization control subsystem is shown in the figure below:

3-6
Working Principle

NCV is an electromagnetic switch valve, which has two states of on and off; R1 is an atomization air-resistor,
which regulates the atomization flow; when the NCV is turned on, the front end is 220kPa±30kPa O2, through
the atomization air-resistor, the rear end forms a continuous flow of 6-9 L/min. This flow flows into the
atomizer through the pneumatic atomization interface on the front of the ventilator, taking away the drug and
finally flowing into the patient. The external structure and dimensions of the atomizer interface comply with
the standard BS EN 13544-2:2002.

Pneumatic
atomization
interface

Turbofan subsystem

The following figure shows the schematic diagram of the turbofan subsystem:

The main function of the turbofan subsystem is to mix air and O2 and deliver the gas mixture to the
lower-level components. The turbofan subsystem is mainly composed of turbofan, turbo radiator, mixed
oxygen outlet box component, negative pressure sensor, labyrinth component, additional temperature sensor,
damping material and sound-absorbing sponge material.
The radiator is connected to the turbofan, which directs the heat generated by the turbofan to the outside, and
forces the heat dissipation through the cooling fan. At the same time, the mixed gas flowing through the
turbofan also takes away part of the heat generated by the turbofan subsystem. The operating temperature of
the turbofan directly affects the service life. Therefore, an additional temperature sensor is used to monitor the

3-7
Working Principle

operating temperature of the turbofan. If the temperature exceeds the standard, the wind speed of the cooling
fan will be increased to increase the heat dissipation capacity of the radiator to the turbofan.
The negative pressure sensor is to monitor the actual negative pressure value at the turbine inlet. Once the
negative pressure exceeds 8 kPa, the ventilator will pop up a medium-level alarm of [Technical Error 01], and
the filter box component must be replaced at this time.
The structural components of the turbofan subsystem are as follows:

Turbine
radiator

Flow regulation subsystem

The main component of the flow regulation subsystem is a low-pressure proportional control valve, which
controls the opening and closing of the valve port through a voice coil motor to provide the pressure and flow
required by the system. At the same time, the low-pressure proportional control valve component also
provides gas source for O2 concentration monitoring. The schematic diagram of the flow regulation
subsystem is as follows:

The structural components of the flow regulation subsystem are as follows:

3-8
Working Principle

Inspiratory flow
Low-pressure sensor
proportional control
valve housing

Voice coil motor

Inspiratory safety valve subsystem

The inspiratory safety valve module is located downstream of the inspiratory flow sensor, and is used as the
inspiratory channel of the system to connect to an external RESP tubing set or other medical accessories. The
module has two main functions: One is the function of active pressure relief, which prevents the pressure of
the gas circuit system from exceeding the set pressure. The specific discharge pressure can be preset according
to the needs of the operator, and the discharge mechanism is controlled by software. The other is to provide a
channel for the patient to breathe independently when the system is completely powered off or on standby to
prevent the patient from suffocating.
The inspiratory safety valve module uses the power-on or power-off control of the electromagnet to close or
open the safety valve. The schematic diagram of the subsystem is as follows:

The component structure of the inspiratory safety valve subsystem is as follows:

3-9
Working Principle

Inspiratory safety valve


base component

Electromagnet

Removable component
of the inspiratory valve

Inspiratory safety
valve plug
Check valve

Main body of the


inspiratory safety
valve

Inspiratory safety
valve knob

Inspiratory
safety valve seat

The module is divided into a fixed part and a detachable part. The fixed part mainly includes an electromagnet,
an inspiratory safety valve base and a floating mechanism, etc., which are screwed to the bracket of the
overall unit to support the entire safety valve component. The detachable part mainly includes an inspiratory
safety valve seat, the main body of the inspiratory safety valve, a check valve, an inspiratory safety valve plug,
and an inspiratory safety valve knob, etc., providing patients with controlled breathing and autonomous
breathing channels, and the client can be disassembled without tools for cleaning and disinfection.
The external output port of the inspiratory safety valve subsystem is the outlet part of the air-capacitor. The
connector complies with the coaxial 22mm/15mm conical connector specified in ISO 5356-1:2004.

3-10
Working Principle

The gas flow direction of the inspiratory safety valve includes the following conditions:
1 When the ventilator is ventilated normally, the valve port is electrically sealed by the electromagnet, and
the gas mixture of air and O2 enters the patient’s body through the safety valve channel. The specific gas
flow diagram is shown in the following figure:

2 When the airway pressure is too high, the electromagnet is powered off and actively opens the pressure
relief channel to ensure the safety of the patient. The specific gas flow direction is shown in the figure
below. When the airway pressure returns to normal, the electromagnet is energized, and the gas flow
situation returns to situation 1.

3 When the patient is breathing spontaneously, the electromagnet is powered off to open the pressure relief
channel, and the patient obtains air from the outside atmosphere to breathe. The specific gas flow
direction is shown in the figure below.

3-11
Working Principle

4 When the machine is accidentally powered down, the electromagnet is powered down to open the
pressure relief channel and support the patient to breathe spontaneously. Refer to situation 3 for the gas
flow direction.

Expiratory valve subsystem

The expiratory valve module mainly realizes the functions of pressure control, pressure monitoring, and flow
monitoring during the patient’s expiration stage. It is significantly different from the inspiratory module in that
the gas flowing through is all the gas exhaled by the patient, which causes the components of the expiratory
module to be cleaned and disinfected before they can be used again. The gas circuit plan of the expiratory
valve subsystem is shown in the figure below:

3-12
Working Principle

The expiratory valve is an electronically controlled expiratory valve. Its working principle is as follows: The
valve closing pressure of the expiratory valve is controlled by the voice coil motor. When the control current
of the system to the voice coil motor is zero, the expiratory valve is fully opened; when the system gives the
voice coil motor a certain control current, the voice coil motor seals the diaphragm at the valve port with a
certain thrust. In order for the patient's exhaled air to pass through the valve port, it must overcome the force
of the gas in the expiratory valve cavity to seal the valve port. This dynamic process finally ensures that the
airway pressure is the set value (this value corresponds to the control current of the voice coil motor
one-to-one).
In the expiration stage, the system gives the voice coil motor a relatively large control current valve closing
operation, and the corresponding valve closing pressure varies according to the parameters set by the
ventilation mode (V-A/C mode is Plimit, P-A/C mode is Pinsp+PEEP, and PSV mode is Psupp+PEEP). The
gas enters the patient first. If the airway pressure is higher than the valve closing pressure during the
inspiration process, the expiratory valve diaphragm opens to release the pressure to ensure the safety of the
patient.
In the expiration stage, the control current of the system to the voice coil motor is zero or a relatively small
value, which corresponds to the full opening of the expiratory valve or the formation of a certain valve closing
pressure. When the expiratory valve is fully opened, it is equivalent to the patient’s exhaled air directly to the
atmosphere (the same as the normal person's expiration); when the expiratory valve has a certain valve closing
pressure, it is equivalent to that the patient’s exhaled air is always maintained at a positive pressure, that is, the
patient’s expiratory pressure is the set PEEP value.
The expiratory flow sensor Q3 is a flow sensor based on the principle of differential pressure, using a
diaphragm sensor (metal diaphragm flow sensor), which is characterized by high sensitivity. The expiratory
module uses a metal diaphragm flow sensor, which supports high-temperature steaming and disinfection at
134℃. However, the diaphragm will be deformed after long-term use, and thus it needs to be calibrated
regularly by the user to maintain measurement accuracy.
When the gas flows through Q3, there will be a pressure difference on both sides of the diaphragm of Q3. This
pressure difference is collected by the differential pressure sensor Pflow and processed to calculate the flow
information. SOL2 and SOL3 are the corresponding three-way valves for zero calibration. The pressure sensor
Exp.P is a sensor that measures the pressure of the expiratory branch. The pressure signal is collected by the
front-end sampling tube of Q3.
In addition, there are two branches that pass through the air-resistor R2, which produces a small flushing
airflow in the pressure sampling tubing set to prevent water vapor from condensing in the pressure sampling
tubing set, thereby affecting the accuracy and precision of pressure measurement.
The structure diagram of the expiratory valve module component is shown below:

3-13
Working Principle

Detachable component
Voice coil motor
of the expiratory valve

Expiratory valve
seat

Patient gas outlet

Tubing set accessories

The patient tubing set is the peripheral gas circuit of the ventilator, which is independent of the main unit of
the ventilator. Different configurations can be selected according to needs, and its main function is to connect
the ventilator and the patient, and to humidify the gas inhaled by the patient.
There are two types of patient tubing set: disposable and reusable. Disposable tubing sets generally integrate
tubing sets, water cup, Y-connector, etc., and are made of PVC material, which have a low cost and are thrown
away after one-time use. Reusable tubing sets are generally made of silica gel, which can be sterilized by high
temperature and high pressure for many times. The materials of the water cup and Y-connector can also be
sterilized by high temperature and high pressure. Although the unit price of reusable tubing sets is relatively
high, clinical costs can be reduced as they can be used multiple times.
The filters are respectively placed at the interface of the inspiration end and the expiration end of the
ventilator with a filtration accuracy of 5μm, which can effectively prevent bacteria in the patient tubing sets
from entering the airway of the ventilator.
The humidifier is placed in the inspiration tubing set, and the dry gas mixture output by the ventilator passes
through the humidifier and becomes warm and saturated gas and enters the patient’s respiratory tract, thereby
avoiding discomfort and complications to the patient.
The atomizer is connected with the atomization gas nozzle on the front panel of the overall unit. The function
of the atomizer is to transform the atomized liquid medicine into gaseous colloidal particles. During the
patient’s inspiration, the medicine is delivered to the patient’s respiratory tract and lungs with the atomized
gas to achieve the purpose of treatment.

3-14
Working Principle

Principle of Circuits

Overview of the hardware board card

The hardware system block diagram of V3 is shown in the figure below. The wiring in the figure is used to
illustrate the connection between hardware board cards, and modules.

Debugging LAN Speaker +


USB*2 HDMI
serial port +WIFI microphone

Interface

LCD screen

Indicator
Output
Interaction

warning light Mainstream CO2/


LVDS Serial SPO2
Main control
sidestream CO2
User

port

Communicati
on serial port
Module
Key encoder monitoring
Serial
port

Touch screen

Calibration
serial port

Interface
Constant 3.3V, system
+5V Serial port

Constant 3.3V, backlight 12V


Interface

Nurse call

AC/DC
switching
power supply
Main unit power supply

DC12V DC-DC power


Monitoring
External DC System 5V, valve 12V

supply
power supply
Voice coil motor 7V,
turbine 24V

Lithium
battery

12V
Heat dissipation

According to the function division in the V3 main unit, the hardware system can be divided into the following
major systems:
Ø Main control system: It is divided into main control core board and part of the monitoring bottom
board;

3-15
Working Principle

Ø Monitoring system: It is divided into sensor board, negative pressure sensor board and part of the
monitoring bottom board;

Ø Power supply system: It is divided into AC-DC power panel, DC power panel, battery adapter board
and lithium battery;

Ø User interaction system: It is divided into key board, encoder board, indicator board, alarm indicator
board, LCD screen and touch screen;

Ø Module monitoring system: mainstream CO2 or sidestream CO2, and SPO2;

Power supply system

Output of the power supply system

Charge and discharge management


Battery level and Low-power
AC/DC
switching DC18V status monitoring CPU Main
power supply control
Constant
3.3V LDO

sequence management
circuit

On-off power-on
Charging
circuit
Power User
5V and 7V
selection DC18V/12V/BAT
DC-DC interac
circuits
Lithium
circuit tion
BAT
battery
12V and 22V
DC-DC
External DC DC12V circuits
power supply System 5V, valve 12V Monito
12V
Buzzer Voice coil motor 7V, turbine 22V ring
Cooling fan Nurse call

1. Main control system


The output of the power supply system to the main control system is the system 5V power supply.

Serial communication, upload power status;

2. User interaction system

The power supply system provides constant 3.3V, system 5V and backlight 12V to the user interaction
system to provide power supply for the hardware circuits of the user interaction system;

AC and external DC power signal acquisition, and light up the corresponding indicator;

The battery status signal is collected, and the indicator light is lighted as required;

3. Monitoring system

The power supply system provides system 5V, valve 12V, voice coil motor 7V and turbine 22V for the
3-16
Working Principle

monitoring system to supply power to the hardware circuits of the monitoring system.

Distribution of each circuit of power supply in the system

Power supply instructions for hardware board cards and related components
Monitoring bottom board +5V;+12V;+22V;+7V
Main control core board +4.2V
Key board +3.3V;+5V;
Alarm indicator board +5V
Encoder board +5V
Sensor board +3.3V;+5V;+10V;+12V
Indicator board +3.3V
Negative pressure sensor board +3.3V
SpO2 board +5V;+12V
Touch screen +3.3V
LCD screen +3.3V;+12V
Cooling fan +12V
O2 proportional valve +12V
Inspiratory/expiratory voice coil motor +7V
Atomization valve +12V
Turbofan +5V;+22V
Mainstream CO2 module +5V
Sidestream CO2 module +5V

Functional description of the board card

For the detailed connection relationship between the board cards, please refer to 2.2.2 Circuit schematic
diagram.

Power supply system board card

The power module mainly includes AC-DC power panel, DC power panel, and battery adapter board.
The main function of each board card is as follows:
u AC-DC power panel: Convert the external AC input power supply to a higher DC power supply (nominal
value is 24V) for use by the DC power panel.
u DC power panel: Under the control of the on-off circuit, the AC-DC output DC power supply, external DC
input or smart battery power supply is converted into various DC power supplies required by the system to
generate 5V, 7V, 12V, 24V, etc., and the smart battery is conducted with charge management at the same
time.
u Battery adapter board: Responsible for switching out the battery signal.

3-17
Working Principle

AC-DC power panel:


AC-DC power panel
AC input DC output

AC-DC converts external AC into internal DC power supply. The CN1 connector of the socket is an AC input
interface, which is defined as follows:

Pin No. Signal name Signal description Remark


1 N AC input 1 AC signal
2 NC No internal connection /
3 L AC input 2 AC signal

The CN101 connector of the AC-DC board is its DC output interface, and the TB2 interface is defined as
follows:

Pin No. Signal name Signal description Remark


1 +V Positive terminal of AC-DC DC output /
2 +V Positive terminal of AC-DC DC output /
3 GND Ground /
4 GND Ground /
DC-DC board:

3-18
Working Principle

DC power panel

Power supply
interface of the
monitoring bottom Cooling fan
board interface

Lithium battery
interface
External DC input

AC-DC input

The J1 connector of the DC power panel is the AC-DC input interface, and its interface is defined as follows:

Pin No. Signal name Signal description Remark


1 AC_DC_IN Input signal of AC-DC output to
Rated current is 8.3A
2 AC_DC_IN DC-DC
7 GND Ground /
8 GND Ground /

3-19
Working Principle

The J2 connector of the DC power panel is an external DC input interface, and its interface is defined as
follows:

Pin No. Signal name Signal description Remark


1 GND Negative terminal of external DC /
2 GND input signal /
3 DC12V Positive terminal of external DC /
4 DC12V input signal /

The J3 connector of the DC power panel is an interface connected to the battery adapter board, and its
interface is defined as follows:

Pin No. Signal name Signal description Remark


1 BATA_ON Battery A in-position signal /
2 BATB_ON Battery B in-position signal /
3 BATA_SCL A battery I2C communication clock /
4 BATB_SCL B battery I2C communication clock /
5 BATA_SDA A battery I2C communication data /
6 BATB_SDA B battery I2C communication data /
7 GND Ground /
8 GND Ground /
9 VBATA Battery A power supply (12V-16.8V) /
10 VBATA Battery A power supply (12V-16.8V) /
11 VBATA Battery A power supply (12V-16.8V) /
12 VBATA Battery A power supply (12V-16.8V) /
13 VBATA Battery A power supply (12V-16.8V) /
14 VBATA Battery A power supply (12V-16.8V) /
15 VBATA Battery A power supply (12V-16.8V) /
16 VBATA Battery A power supply (12V-16.8V) /
17 GND Ground /
18 GND Ground /
19 GND Ground /
20 GND Ground /
21 GND Ground /
22 GND Ground /
23 GND Ground /
24 GND Ground
25 VBATB Battery B power supply (12V-16.8V)

3-20
Working Principle

26 VBATB Battery B power supply (12V-16.8V)


27 VBATB Battery B power supply (12V-16.8V)
28 VBATB Battery B power supply (12V-16.8V)
29 VBATB Battery B power supply (12V-16.8V)
30 VBATB Battery B power supply (12V-16.8V)
31 VBATB Battery B power supply (12V-16.8V)
32 VBATB Battery B power supply (12V-16.8V)
33 GND Ground
34 GND Ground
35 GND Ground
36 GND Ground
37 GND Ground /
38 GND Ground /
39 GND Ground /
40 GND Ground /

The J7 connector of the DC-DC board is an interface connected to the main board of the monitoring module,
and its interface is defined as follows:

Pin No. Signal name Signal description Remark


1 NC NC /
2 NC NC /
3 VDD12V0 Power 12V power supply /
4 VDD12V0 Power 12V power supply /
5 GND Ground /
6 GND Ground /
7 V5M System 5V power supply /
8 V5M System 5V power supply /
9 GND Ground /
10 GND Ground /
11 VCC7V0 Voice coil motor 7V power supply /
12 VCC7V0 Voice coil motor 7V power supply /
13 GND Ground /
14 GND Ground /
15 GND Ground /
16 GND Ground /
17 GND Ground /
18 GND Ground /

3-21
Working Principle

19 V22B Turbine 22V power supply /


20 V22B Turbine 22V power supply /
21 V22B Turbine 22V power supply /
22 V22B Turbine 22V power supply /
23 ADP_LED External power indicator control signal /
24 V3C Constant 3.3V power supply /
25 BAT_LED Battery indicator control signal /
26 MIC_OUT_LP Buzzer detection circuit MIC signal input /
27 SW_WKUP On-off key signal /
28 RUN_LED Operation indicator control signal /
Serial communication with the main
29 TOCORE_TX /
control system (TTL) TX
Serial communication with the main
30 FROMCORE_RX
control system (TTL) RX
31 C_BEEP_LP Buzzer alarm control
32 NURSE_CALL_LP Nurse call interface control output /

The J4 connector of the DC-DC board is an interface connected to the cooling fan, and its interface is defined
as follows:

Pin No. Signal name Signal description Remark


1 FAN+ Fan+ /
2 NC NC /
Speed feedback, add 10K pull-up
3 FB_FAN /
resistor;
4 FAN- Fan- /
Battery adapter board:
Battery adapter board

Lithium battery A interface DC power panel interface DC power panel interface

The J1 connector of the battery adapter board is an interface connected to the DC power panel, and its
interface is defined as follows:

3-22
Working Principle

Pin No. Signal name Signal description Remark


1 BATA_ON Battery A in-position signal /
2 BATB_ON Battery B in-position signal /
3 BATA_SCL A battery I2C communication clock /
4 BATB_SCL B battery I2C communication clock /
5 BATA_SDA A battery I2C communication data /
6 BATB_SDA B battery I2C communication data /
7 GND Ground /
8 GND Ground /
9 VBATA Battery A power supply (12V-16.8V) /
10 VBATA Battery A power supply (12V-16.8V) /
11 VBATA Battery A power supply (12V-16.8V) /
12 VBATA Battery A power supply (12V-16.8V) /
13 VBATA Battery A power supply (12V-16.8V) /
14 VBATA Battery A power supply (12V-16.8V) /
15 VBATA Battery A power supply (12V-16.8V) /
16 VBATA Battery A power supply (12V-16.8V) /
17 GND Ground /
18 GND Ground /
19 GND Ground /
20 GND Ground /
21 GND Ground /
22 GND Ground /
23 GND Ground /
24 GND Ground /
25 VBATB Battery B power supply (12V-16.8V) /
26 VBATB Battery B power supply (12V-16.8V) /
27 VBATB Battery B power supply (12V-16.8V) /
28 VBATB Battery B power supply (12V-16.8V) /
29 VBATB Battery B power supply (12V-16.8V) /
30 VBATB Battery B power supply (12V-16.8V) /
31 VBATB Battery B power supply (12V-16.8V) /
32 VBATB Battery B power supply (12V-16.8V) /
33 GND Ground /
34 GND Ground /
35 GND Ground /
36 GND Ground /

3-23
Working Principle

37 GND Ground /
38 GND Ground /
39 GND Ground /
40 GND Ground /

The J2 connector of the battery adapter board is an interface connected to the lithium battery A, and its
interface is defined as follows:

Pin No. Signal name Signal description Remark


1 GND Ground /
2 GND Ground /
3 GND Ground /
4 BATA_ON Battery A in-position signal /
5 BATA_SDA A battery A I2C communication data /
6 BATA_SCL A battery A I2C communication clock /
7 NC NC /
8 VBATA Battery A power supply (12V-16.8V) /
9 VBATA Battery A power supply (12V-16.8V) /
10 VBATA Battery A power supply (12V-16.8V) /

The J3 connector of the battery adapter board is an interface connected to the lithium battery B, and its
interface is defined as follows:

Pin No. Signal name Signal description Remark


1 GND Ground /
2 GND Ground /
3 GND Ground /
4 BATB_ON Battery B in-position signal /
5 BATB_SDA B battery B I2C communication data /
6 BATB_SCL B battery B I2C communication clock /
7 NC NC /
8 VBATB Battery B power supply (12V-16.8V) /
9 VBATB Battery B power supply (12V-16.8V) /
10 VBATB Battery B power supply (12V-16.8V) /

Main control core board

The main control core board contains the main control core board and peripheral interface circuits (on the
monitoring bottom board). It is the core of ventilator control, which mainly realizes man-machine interface
(display interface, external key input), control command issuing, alarm, and ventilator protection functions,
CO2 and SPO2 parameter modules and peripheral interface circuits.
3-24
Working Principle

Main control core board: It mainly realizes the minimum core system of the main control module, and
connects the pins of the minimum system to the monitoring bottom board.
Main control core board

Monitoring system

The monitoring system mainly includes the following board cards: monitoring bottom board, sensor board,
and negative pressure sensor board.
Monitoring bottom board:
The monitoring bottom board is the core board card of V3 implementation and the implementer of ventilator
parameter function, including the VCM control module, VPM protection module, and peripheral interface
circuits of the main control module. It mainly implements the following functions:
1. It is responsible for the control of all valves and the AD acquisition of analog quantities.
2. Drive the turbofan, and control the turbofan.
3. Monitor the negative pressure and temperature of the turbine.
4. Monitor pressure and flow signal input, and convert analog quantity into digital quantity.
5. Carry out UART communication with the main control board.
6. Realize the peripheral interface circuits of the main control board, such as wired and wireless network, USB,
HDMI, display interface, nurse call, etc.

3-25
Working Principle

Power indicator D2 of the Network CAL & nurse call Atomization External turbine
main control core board interface Inspiratory valve O2 valve temperature
Expiratory value valve

Turbine fault
indicator

VCM power
indicator

DC power panel
interface

Indicator board
interface

CO2 speaker VPM fault indicator


Negative pressure Display Sensor board interface 1
D3 Sensor board interface 2
sensor interface

Indicator description table:


Item Meaning of status indicator
On: If the turbine or drive circuit is faulty, please confirm whether the
wire of the turbine interface is plugged in, otherwise it is the fault of the
turbofan itself or the monitoring bottom board;
Turbine fault indicator D66 Flashing: Flashing is normal when the turbine is re-accelerating; flashing
during standby is a fault state, and the troubleshooting method is the same
as above;
Off: Normal operation.
Off: Power failure, please enter the AD channel to see if there is any
abnormality in the voltage value sampled by the AD value (abnormality
VCM power indicator D32
is displayed in red font).
On: Normal operation.
Off: Power failure, please enter the AD channel to see if there is any
Power indicator D2 of the main abnormality in the voltage value sampled by the AD value (abnormality
control core board is displayed in red font).
On: Normal operation.
On/off: VCM software failure, restart to see if it disappears; if not, the
monitoring bottom board is damaged, replace the monitoring bottom
VPM fault indicator D1
board;
Flashing: Normal operation.
VPM fault indicator D3 On/off: VCM software failure, restart to see if it disappears; if not, the

3-26
Working Principle

monitoring bottom board is damaged, replace the monitoring bottom


board; if it does not work, it is a power failure, please enter the AD
channel to see if there is any abnormality in the voltage value sampled by
the AD value (abnormality is displayed in red font).
Flashing: Normal operation.

The J1 connector of the power supply interface of the monitoring bottom board is an interface connected to
the DC power panel, and its interface is defined as follows:

Pin No. Signal name Signal description Remark


1 VADP External power indicator control signal /
2 V3C Constant 3.3V power supply /
3 BAT_LED Battery indicator control signal /
Buzzer detection circuit MIC signal
4 MIC_OUT_LP /
input
5 SW_WKUP On-off key signal /
6 CTRL_RUN_LED Operation indicator control signal /
Serial communication with the main
7 FROMLP_RX /
control system (TTL) TX
Serial communication with the main
8 TOLP_TX /
control system (TTL) TX
9 C_BEEP_LP Buzzer alarm control /
10 NC NC /
11 VDD12V0 Power 12V power supply /
12 VDD12V0 Power 12V power supply /
13 GND Ground /
14 GND Ground /
15 V5M System 5V power supply /
16 V5M System 5V power supply /
17 GND Ground /
18 GND Ground /
19 VCC7V0 Voice coil motor 7V power supply /
20 VCC7V0 Voice coil motor 7V power supply /
21 GND Ground /
22 GND Ground /
23 GND Ground /
24 GND Ground /
25 GND Ground /
26 GND Ground /

3-27
Working Principle

27 V22B Turbine 22V power supply /


28 V22B Turbine 22V power supply /
29 V22B Turbine 22V power supply /
30 V22B Turbine 22V power supply

The J41 connector of the monitoring bottom board is an interface connected to the indicator board, and its
interface is defined as follows:

Pin No. Signal name Signal description Remark


1 VADP External power indicator control pin /
2 V3C Constant 3.3V power supply /
3 GND Ground /
4 BAT_LED Battery indicator control pin /
5 CTRL_RUN_LED Operation indicator control pin /
6 SW_WKUP On-off key signal pin /

The J42 of the monitoring bottom board is a power interface connected to the sensor board, which is defined
as follows:

Pin No. Signal name Signal description Remark


Control wire of the inspiratory pressure zero
1 ZVPI /
calibration valve
Control wire of the expiratory pressure zero
2 ZVPE /
calibration valve
Control wire of the expiratory flow zero
3 ZVFE /
calibration valve
Control wire of the proximal nasal pressure
4 ZVPCN /
zero calibration valve
Control wire of the proximal nasal flow zero
5 ZVFCN /
calibration valve
Control wire of the hybrid chamber pressure
6 ZVPMIX /
zero calibration valve
7 GND Ground /
8 GND Ground /
9 VZ Zero calibration valve power supply 12V /
10 VZ Zero calibration valve power supply 12V /
11 HEAT Control wire of the heating wire /
12 HEAT Control wire of the heating wire /
13 VH Heating wire power supply 12V /
14 VH Heating wire power supply 12V /

3-28
Working Principle

15 SAFEVAL Control wire of the safety valve /


16 SAFEVAL Control wire of the safety valve /
17 V12SF Safety valve power supply 12V /
18 V12SF Safety valve power supply 12V /
19 GND Ground /
20 GND Ground /

The J20 of the monitoring bottom board is an analog interface connected to the sensor board, which is defined
as follows:

Pin No. Signal name Signal description Remark


1 GND Analog ground /
2 GND Analog ground /
3 ADC_PE Expiratory pressure sensor signal /
4 ADC_PMIX Hybrid chamber sensor signal /
5 ADC_PI Inspiratory pressure sensor signal /
6 GND Analog ground /
7 VF_EXP Expiratory flow sensor signal /
8 GND Analog ground /
9 VSEN Sensor power supply 10V /
10 VSEN Sensor power supply 10V /
11 GND Analog ground /
12 GND Analog ground /
13 ADC_O2 O2 concentration sensor signal /
14 ADC_REF Sensor reference supply voltage signal /
15 VT_INS Inspiratory flow sensor VT signal /
16 VF_INS Inspiratory flow sensor VF signal /
17 VT_O2 O2 flow sensor VT signal /
18 VF_O2 O2 flow sensor VF signal /
19 VCC7V0 TSI heater supply 7V /
20 VCC7V0 TSI heater supply 7V /
21 GND Analog ground /
22 GND Analog ground /
Heating element temperature sensor 1
23 ADC_TEMP1 /
signal
Heating element temperature sensor 2
24 ADC_TEMP2 /
signal
25 ADC_Q5V Heater sensor 5V sampling /

3-29
Working Principle

Internal EEPROM power supply of TSI


26 V3D /
flow sensor
27 TSI_SDA_O2 I2C data cable SDA of O2 TSI sensor /
Internal EEPROM digital ground GND
28 GND /
of TSI flow sensor
I2C data cable SDA of inspiratory TSI
29 TSI_SDA_INS /
sensor
30 TSI_SCL_VCM I2C clock cable SCL of TSI sensor

The J13 of the monitoring bottom board is an analog interface connected to the display, which is defined as
follows:

Pin No. Signal name Signal description Remark


1 GND Ground /
2 GND Ground /
3 BL_POWER_CTRL Key board backlight power control pin /
4 GND Ground /
5 V5S System 5V /
6 GND Ground /
7 GND Ground /
8 GND Ground /
Serial communication with the key board
9 TOKEY_RX /
(TTL) TX
Serial communication with the key board
10 FROMKEY_TX /
(TTL) TX
Touch screen I2C communication SDA
11 SDA_CTS /
pin
Touch screen I2C communication SCL
12 SCL_CTS /
pin
Touch screen I2C communication reset
13 RESET_CTS /
pin
Touch screen I2C communication
14 INT_CTS /
interrupt pin
15 GND Ground /
16 CTS_POWER_EN Capacitive screen power control pin /
17 VDD_3V3 Main control 3.3V /
18 VDD_3V3 Main control 3.3V /
Key board backlight PWM brightness
19 BL_PWM /
control pin

3-30
Working Principle

20 BL_EN Key board backlight enable control pin /


21 BL_PWM Display backlight brightness control pin /
22 GND Ground /
23 BL_EN Display backlight enable pin /
24 YD3+ LVDS signal /
25 GND Ground /
26 YD3- LVDS signal /
27 GND Ground /
28 GND Ground /
29 GND Ground /
30 CLK+ LVDS signal /
31 GND Ground /
32 CLK- LVDS signal /
33 LCD12V Backlight 12V /
34 GND Ground /
35 LCD12V Backlight 12V /
36 YD2+ LVDS signal /
37 LCD12V Backlight 12V /
38 YD2- LVDS signal /
39 LCD12V Backlight 12V /
40 GND Ground /
41 SEL6/8 LVDS signal bit selection pin /
42 YD1+ LVDS signal /
43 GND Ground /
44 YD1- LVDS signal /
45 LCD+3.3V Display screen 3.3V /
46 GND Ground /
47 LCD+3.3V Display screen 3.3V /
48 YD0+ LVDS signal /
49 GND Ground /
50 YD0- LVDS signal

J12 is the CO2 module interface, and its interface is defined as follows:

Pin No. Signal name Signal description Remark


1 5V_CO2 CO2 power supply 5V /
2 GND Ground /
3 CO2_TX_232 232 serial port transmission /

3-31
Working Principle

4 CO2_RX_232 232 serial port reception /

J8 is the speaker interface, and its interface is defined as follows:

Pin No. Signal name Signal description Remark


1 SPK2 Speaker drive signal- /
2 SPK1 Speaker drive signal+ /

J15 is the interface between the monitoring bottom board and the negative pressure sensor board, and its
interface is defined as follows:

Pin No. Signal name Signal description Remark


1 GND Ground /
Negative pressure sensor power supply,
2 MAIN_3.3V /
3.3V
I2C interface data cable of negative
3 Ms5607_SDA /
pressure sensor
I2C interface data cable of negative
4 Ms5607_SCL /
pressure sensor
5 GND Ground /
6 GND Ground /

J10 is the interface between the monitoring bottom board and the SpO2 bottom board, and its interface is
defined as follows:

Pin No. Signal name Signal description Remark

1 VDD12V0 SpO2 12V power supply /


2 V5M SpO2 communication 5V power supply /

3 GND Ground /
4 SPO2_TX5V SpO2 TTL serial port transmission /

5 SPO2_RX5V SpO2 TTL serial port reception /

J36 is an interface connected to the expiratory valve, and its interface is defined as follows:

Pin No. Signal name Signal description Remark


Negative terminal of the expiratory
1 VAL_EX- /
valve
Negative terminal of the expiratory
2 VAL_EX- /
valve
3 NC / Suspension
4 VAL_EX+ Positive terminal of the expiratory /

3-32
Working Principle

valve
Positive terminal of the expiratory
5 VAL_EX+ /
valve

J14 is the HDMI interface of the external display socket, and its interface is defined as follows:

Pin No. Signal name Signal description Remark

1 HDMI_D2P HDMI differential signal /


2 GND Ground /
3 HDMI_D2M HDMI differential signal /
4 HDMI_D1P HDMI differential signal /
5 GND Ground /
6 HDMI_D1M HDMI differential signal /
7 HDMI_D0P HDMI differential signal /
8 GND Ground /
9 HDMI_D0M HDMI differential signal interface /
10 HDMI_CLKP HDMI differential signal /
11 GND Ground /
12 HDMI_CLKM HDMI differential signal /
13 HDMI_CEC_OUT HDMI CEC signal /
14 NC NC /
15 H_SCL_OUT HDMI I2C clock signal /
16 H_SDA_OUT HDMI I2C data signal /
17 GND Ground /
18 HDMI_5V_OUT HDMI 5V output /
19 HP_DET_OUT HDMI DET signal /
20 GND Ground /
21 GND Ground /
22 GND Ground /
23 GND Ground /

J11 is an external USB interface, and its interface is defined as follows:

Pin No. Signal name Signal description Remark


1 5V_CLIMIT USB power supply 5V
2 USB_DMB USBB signal cable /
3 USB_DPB USBB signal cable /

3-33
Working Principle

4 GND Ground /
5 5V_CLIMIT USB power supply /
6 USB_DMA USBA signal cable /
7 USB_DPA USBA signal cable /
8 GND Ground /
9 GND Ground /
10 GND Ground /
11 GND Ground /
12 GND Ground /

J9 is the network interface, and its interface is defined as follows:

Pin No. Signal name Signal description Remark


1 TX+ Main control network transmission signal + /
2 TX- Main control network transmission signal - /
3 RX+ Main control network reception signal + /
4 NC NC /
5 NC NC /
6 RX- Main control network transmission signal - /
7 NC NC /
8 NC NC /

J39 is the calibration serial port and external nurse call interface, and its interface is defined as follows:

Pin No. Signal name Signal description Remark

1 NC1 Nurse call signal 1 /


2 NC2 Nurse call signal 2 /
3 NC NC /
4 NC NC /
5 NC NC /
6 NC NC /
7 NC NC /
8 NC NC /
9 NC NC /
10 NC NC /
11 CLBR_RX_VCM_232 VCM calibration serial port reception /
Main control debugging serial port
12 DEBUG_TX_IMX7_232 /
transmission

3-34
Working Principle

13 GND Ground /
14 NC NC /
15 NC NC /
VCM calibration serial port
16 CLBR_TX_VCM_232 /
transmission
Main control debugging serial port
17 DEBUG_RX_IMX7_232 /
reception
18 GND Ground /
19 RTS RTS pin /
20 GND Ground /
21 GND Ground /
22 GND Ground /

J37 is an interface connected to the inspiratory valve, and its interface is defined as follows:

Pin No. Signal name Signal description Remark


Negative terminal of the inspiratory
1 VOICE_POWER /
valve
Negative terminal of the inspiratory
2 VOICE_POWER /
valve
3 / / Suspension
Positive terminal of the inspiratory
4 VAL_INS+ /
valve
Positive terminal of the inspiratory
5 VAL_INS+ /
valve

J35 is the atomization valve interface, and its interface is defined as follows:

Pin No. Signal name Signal description Remark


Atomization valve power supply,
1 V12D /
12V
2 NC NC /
Control terminal of the atomization
3 ATOMVAL /
valve

J38 is the O2 proportional valve interface, and its interface is defined as follows:

Pin No. Signal name Signal description Remark


Control terminal of the O2
1 O2_Val /
proportional valve

3-35
Working Principle

O2 proportional valve power supply


2 O2VAL_POWER /
12V

J19 is an interface for connecting the external temperature sensor of the turbine, and its interface is defined as
follows:

Pin No. Signal name Signal description Remark


1 NTC- One terminal of the temperature sensor Both terminals are
2 NTC+ The other terminal of the temperature sensor positive or negative

J18 is the turbine interface, and its interface is defined as follows:

Pin No. Signal name Signal description Remark


1 HALL_U0 Hall position signal U0 /
2 HALL_V0 Hall position signal V0 /
3 V5M Hall sensor power supply /
4 MOTOR_W Turbofan drive signal W /
5 MOTOR_NTC One terminal of the thermistor /
6 HALL_W0 Hall position signal W /
7 GND Ground /
8 MOTOR_U Turbofan drive signal U /
9 MOTOR_V Turbofan drive signal V /
10 POWER_NTC The other terminal of the thermistor /

Sensor board:
The sensor board is a V3 board card that realizes the acquisition of analog signals, the acquisition of various
sensor parameters of the ventilator, and the switching function of the safety valve and each zero calibration
valve circuit. It mainly implements the following functions:

1. Place the inspiration, expiration, hybrid chamber pressure sensors and amplifier circuits;

2. Place the expiratory flow sensor and amplifier circuits;

3. Transfer the inspiratory flow, O2 flow, and O2 concentration sensor signal;

4. Transfer the control signal of the safety valve;

5. Transfer the control signal of the zero calibration valve;

3-36
Working Principle

Hybrid pressure
Expiratory pressure sensor Inspiratory pressure
O2 flow Expiratory flow sensor Safety valve
Zero sensor sensor
sensor Inspiratory flow Interface with the interface
calibration interface sensor monitoring board Interface 2 with the
valve Zero calibration valve
Zero calibration valve monitoring board
interface Zero calibration valve interface
interface
interface

The J10 of the sensor board is a power interface connected to the monitoring bottom board, which is defined
as follows:

Pin No. Signal name Signal description Remark


Control wire of the inspiratory pressure zero
1 ZVPI /
calibration valve
Control wire of the expiratory pressure zero
2 ZVPE /
calibration valve
Control wire of the expiratory flow zero
3 ZVFE /
calibration valve
4 NC NC /
5 NC NC /
Control wire of the hybrid chamber pressure
6 ZVPMIX /
zero calibration valve
7 NC NC /
8 NC NC /
9 V5Z Zero calibration valve power supply 5V /
10 V5Z Zero calibration valve power supply 5V /
11 HEAT Control wire of the heating wire /
12 HEAT Control wire of the heating wire /
13 VH Heating wire power supply 12V /
14 VH Heating wire power supply 12V /
15 SAFEVAL Control wire of the safety valve /
16 SAFEVAL Control wire of the safety valve /
17 V12SF Safety valve power supply 12V /
18 V12SF Safety valve power supply 12V /
19 NC NC /
20 NC NC /

3-37
Working Principle

The J11 of the sensor board is an analog interface connected to the monitoring bottom board, which is defined
as follows:

Pin No. Signal name Signal description Remark


1 AGND Analog ground GND /
2 AGND Analog ground GND /
3 ADC_PE Expiratory pressure sensor signal /
4 ADC_PMIX Hybrid chamber sensor signal /
5 ADC_PI Inspiratory pressure sensor signal /
6 AGND Analog ground GND /
7 VF_EXP Expiratory flow sensor signal /
8 AGND Analog ground GND /
9 V10P Sensor power supply 10V /
10 V10P Sensor power supply 10V /
11 AGND Analog ground GND /
12 AGND Analog ground GND /
13 ADC_O2 O2 concentration sensor signal /
14 ADC_REF Sensor reference supply voltage signal /
15 VT_INS Inspiratory flow sensor VT signal /
16 VF_INS Inspiratory flow sensor VF signal /
17 VT_O2 O2 flow sensor VT signal /
18 VF_O2 O2 flow sensor VF signal /
19 VCC7V0 TSI heater supply 7V /
20 VCC7V0 TSI heater supply 7V /
21 AGND Analog ground GND /
22 AGND Analog ground GND /
Heating element temperature sensor 1
23 ADC_TEMP1 /
signal
Heating element temperature sensor 2
24 ADC_TEMP2 /
signal
25 ADC_Q5V Heater sensor 5V sampling /
Internal EEPROM power supply of TSI
26 V3D /
flow sensor
27 TSI_SDA_O2 I2C data cable SDA of O2 TSI sensor /
28 AGND Analog ground GND /
I2C data cable SDA of inspiratory TSI
29 TSI_SDA_INS /
sensor
30 TSI_SCL_VCM I2C clock cable SCL of TSI sensor

3-38
Working Principle

The J1 of the sensor board is an interface connected to the O2 battery, which is defined as follows:

Pin No. Signal name Signal description Remark


1 AGND Analog ground GND /
Positive terminal of the O2 concentration
2 O2+ /
sensor
3 AGND Analog ground GND /
Negative terminal of the O2 concentration
4 O2- /
sensor

The J9 of the sensor board is an interface connected to the inspiratory flow sensor, which is defined as
follows:

Pin No. Signal name Signal description Remark


1 VF_IN Flow signal /
2 NC NC /
3 VT_IN Temperature signal /
4 AGND Analog ground /
5 TSI_SCL_VCM I2C clock signal /
6 TSI_SDA_INS I2C data signal /
7 NC NC /
8 V5Q Sensor power supply 5V /
9 AGND Analog ground /
Internal EEPROM power supply 3.3V of
10 V3D /
the sensor

The J8 of the sensor board is an interface connected to the O2 flow sensor, which is defined as follows:

Pin No. Signal name Signal description Remark

1 VF_O2 Flow signal /


2 NC NC /
3 VT_O2 Temperature signal /
4 AGND Analog ground /
5 TSI_SCL_VCM I2C clock signal /
6 TSI_SDA_INS I2C data signal /
7 NC NC /
8 V5Q Sensor power supply 5V /
9 GND Digital ground /
10 V3D Internal EEPROM power supply 3.3V /

3-39
Working Principle

of the sensor

The J15 of the sensor board is an interface connected to the safety valve, which is defined as follows:

Pin No. Signal name Signal description Remark

1 SAFAVAL Safety valve control pin /


2 V12SF Safety valve power supply /

The J47, J46, J49 and J48 of the sensor board are the interfaces connected to the zero calibration valve board,
which are defined as follows:

Pin No. Signal name Signal description Remark


1 V5Z Zero calibration valve power supply /
Control pin of the inspiratory pressure zero
2 ZVPI /
calibration valve
1 V5Z Zero calibration valve power supply /
Control pin of the expiratory pressure zero
2 ZVPE /
calibration valve
1 V5Z Zero calibration valve power supply /
Control pin of the expiratory flow zero
2 ZVFE /
calibration valve
1 V5Z Zero calibration valve power supply /
Control pin of the hybrid chamber pressure
2 ZVPMIX /
zero calibration valve

Negative pressure sensor board:


It is used to measure the negative pressure at the turbofan. If the turbine air inlet is blocked, an alarm will be
issued, prompting to replace the filter cotton.
J1 is the interface between the monitoring bottom board and the negative pressure sensor board, and its
interface is defined as follows:

Pin No. Signal name Signal description Remark


1 GND Ground /
Negative pressure sensor power
2 V3D /
supply, 3.3V
I2C interface clock of negative
3 SCK /
pressure sensor
I2C interface data cable of negative
4 SDA MOSI /
pressure sensor
5 MISO / /
6 CS / /

3-40
Working Principle

Display module

The main functions of the user interaction system are applied to man-machine interaction, expressing various
information of the ventilator to the user through sound, light, electricity and other media, and conveying the
user’s operation intention to the ventilator main control system through various input equipment;
The distribution of user interaction system board cards of V3 ventilator includes:
Ø Key board;

1. Process key input and encoder input


2. Drive the alarm indicator
3. Carry out UART communication with the main control board.
4. Transfer touch screen input.
5. Provide a mute key

Ø Encoder board;

It is used to select and confirm the touch keys on the ventilator display

Ø Alarm indicator board;

Support red and yellow alarm display.

Ø Indicator board;

1. Drive indicator (battery and external power supply)

2. Provide an on/off key.

Since the appearance requires the indicator and the on/off key to be placed on the main unit of the ventilator,
an indicator board is added to perform this part of the function;
Key board:
The J2 of the key board is an interface connected to the monitoring bottom board, which is defined as follows:

Pin No. Signal name Signal description Remark


1 VDD_3V3 Main 3.3V /
2 CTS_POWER_EN Capacitive screen power control pin /
3 VDD_3V3 Main 3.3V /
4 GND Ground /
5 SCL_CTS Touch screen SCL signal /
6 SDA_CTS Touch screen SDA signal /
7 RESET_CTS Touch screen reset signal /
8 INT_CTS Touch screen interrupt signal /
Communication serial port TX with the
9 FROMKEY_TX /
main control core board

3-41
Working Principle

Communication serial port RX with the


10 TOKEY_RX /
main control core board
11 GND Ground /
12 GND Ground /
Screen backlight brightness regulation
13 BL_PWM /
PWM signal
14 BL_EN Screen backlight enable signal /
15 V5S System 5V /
16 BL_POWER_CTRL Screen backlight power control signal /
17 GND Ground /
18 GND Ground /
19 GND Ground /
20 GND Ground /

The J6 of the key board is an interface connected to the alarm indicator board, which is defined as follows:

Pin No. Signal name Signal description Remark


Ambient light sensor 3.3V power
1 +3V3 /
supply
2 AM_INT_3.3 Ambient light sensor interrupt signal /
3 IIC_SCL_3.3 Ambient light sensor SCL signal /
4 IIC_SDA_3.3 Ambient light sensor SDA signal /
5 GND Ground /
6 ALARMLED Alarm indicator power supply 5V /
7 LED_YELLOW Alarm yellow indicator control pin /
8 LED_RED Alarm red indicator control pin /
9 GND Ground /
10 GND Ground /

The J8 of the key board is an interface connected to the encoder board, which is defined as follows:

Pin No. Signal name Signal description Remark


1 MUTE Mute key signal /
2 V5S System 5V /
3 MOUSE_A Encoder rotation signal A /
4 MOUSE_B Encoder rotation signal B /
5 MOUSE_ENTER Encoder confirmation signal /
6 GND Ground /

The J7 of the key board is an interface connected to the touch screen, which is defined as follows:

3-42
Working Principle

Pin No. Signal name Signal description Remark


1 GND Ground /
2 CTS_3V3 Touch screen 3.3V /
3 SDA_CTS Touch screen SDA signal /
4 SCL_CTS Touch screen SCL signal /
5 INT_CTS Touch screen interrupt signal /
6 RESET_CTS Touch screen reset signal /

Alarm indicator board:


The J1 of the alarm indicator board is an interface connected to the key board, which is defined as follows:

Pin No. Signal name Signal description Remark


+3V3 Ambient light sensor 3.3V power /
1
supply
2 AM_INT_3.3 Ambient light sensor interrupt signal /
3 IIC_SCL_3.3 Ambient light sensor SCL signal /
4 IIC_SDA_3.3 Ambient light sensor SDA signal /
5 GND Ground /
6 LEDBARVDD Alarm indicator power supply 5V /
7 LED_YELLOW Alarm yellow indicator control pin /
8 LED_RED Alarm red indicator control pin /
9 GND Ground /
10 GND Ground /

Encoder board:
The J1 of the encoder board is an interface connected to the key board, which is defined as follows:

Pin No. Signal name Signal description Remark


1 MUTE Mute key signal /
2 V5S System 5V /
3 MOUSE_A Encoder rotation signal A /
4 MOUSE_B Encoder rotation signal B /
5 MOUSE_ENTER Encoder confirmation signal /
6 GND Ground /
7 GND Ground /
8 GND Ground /

Indicator board:
The J3 connector of the indicator board is an interface connected to the monitoring bottom board, and its
interface is defined as follows:

3-43
Working Principle

Pin No. Signal name Signal description Remark


1 ADP_LED External power indicator control pin /
2 V3C Constant 3.3V power supply /
3 EGND Ground /
4 BAT_LED_GREEN Battery indicator control pin /
5 CTRL_RUN_LED Operation indicator control pin /
6 SW_WKUP On-off key signal pin /

3-44
Chapter 4 Inspection and Test

Warning
l After maintaining the equipment or replacing parts, please complete all tests in this section.

l Before performing the test, please completely reinstall the equipment and perform necessary
calibration with reference to Chapter 6 Maintenance and Calibration.

System Inspection

Attention

l Ensure that the RESP system is properly connected and intact.

Please ensure that the following requirements are met during system inspection:
1. The equipment is intact.
2. All parts are connected correctly.
3. The respiratory system (including the inspiratory safety valve, expiratory valve, humidifier and atomizer,
etc.) is connected correctly, and the RESP tubing set is intact.
4. The gas supply system is connected correctly, and the gas source pressure is within the normal range.
5. If there is a spare cylinder, check whether the valve of the connected cylinder is closed.
6. Ensure that the casters are not damaged or loose, and the brakes are locked. The ventilator cannot be
moved after the brake is locked.
7. Check whether the power cord is properly connected, and whether the external power indicator and
battery indicator are normal.
8. Check whether the ventilator can be turned on and off normally.

Power Failure Alarm Test (External Power Supply and Buzzer)

1. Connect the ventilator to AC power supply, and the AC power indicator and battery indicator are on. If
the AC power indicator does not light up, check the fuse and power board.
2. Press the power switch to turn on the ventilator.
3. In the power-on state, disconnect the power socket, the low-level alarm of [Battery in Use] will be
activated, at the same time the power indicator will be off, and the battery indicator will be always on.
4. Reconnect the AC power supply, the [Battery in Use] alarm will automatically reset, the power indicator
will be on, and the battery indicator will flash.
5. Remove the ventilator battery and disconnect the power socket at the same time, the ventilator will shut
down and trigger the buzzer for more than 120s. If the buzzer does not sound, replace the monitoring
4-1
Inspection and Test

board.

O2 Gas Supply Pipeline Test

1. Connect to O2 pipeline gas source.


2. Connect and test the splint lung.
3. Press the system switch to turn on the ventilator.
4. In the standby mode, select the [New Patient-Adult] key, set the ventilation type to [Non-invasive], and
set the O2 concentration to 40 vol.%, and then select the [Start Ventilation] key to enter the ventilation
state.
5. Ensure that the ventilator can ventilate normally.
6. Cut off the gas supply to the O2 pipeline.
7. As the pressure of the O2 source decreases, a high-level alarm of [Insufficient O2 Supply] will be
triggered.

System Test

1. Enter the system self-test


n After powering on, enter the system self-test interface, follow the prompts to connect the O2 source and
close the Y-shaped tube. After completion, select [Continue], and the system will start self-test item by
item.
n Select the [Standby] key and enter the standby interface after confirmation. The standby interface will
display the time and result of the last system self-test. Select the [System Self-test] key, follow the
prompts to connect the O2 source and close the Y-shaped tube. After completion, select [Continue], and
the system will start self-test item by item.
2. The items included in the system self-test are:
n Turbine test: Test the speed of the turbine.
n O2 flow sensor test: Test the O2 flow sensor.
n Inspiratory flow sensor test: Test the inspiratory valve and flow sensor.
n Expiratory flow sensor test: Test the expiratory flow sensor.
n Pressure sensor test: Test the pressure sensors on the inspiration and expiration ends.
n Expiratory valve test.
n Safety valve test.
n Leakage rate (ml/min).
n Compliance (mL/cmH2O).
n Tubing set resistance (cmH2O/L/s).
n O2 sensor test.
3. The self-test results of the above-mentioned system self-test items are as follows:
n Pass: It indicates that the inspection of the item has been completed and the self-test has been
successfully passed.
n Fail: It indicates that the inspection of the item has been completed but the self-test has not passed.
4-2
Inspection and Test

n Cancel: It indicates that the inspection of the item has been cancelled.
n Insufficient O2 supply: It indicates that the O2 supply is insufficient during the O2 flow sensor test and
the O2 sensor test.
n The monitoring function is off: It indicates that the O2 sensor monitoring function may not be turned on
during the O2 sensor test.
4. The total self-test results after all self-test items are completed are as follows:
n Pass: It indicates that all self-test items have successfully passed the self-test.
n Partially passed: It indicates that some self-test items have failed, but mechanical ventilation is allowed.
n Fail, mechanical ventilation is unavailable: It indicates that some important self-test items have failed,
and mechanical ventilation is not allowed.
n Excessive leakage, mechanical ventilation is unavailable: It indicates that the expiratory flow sensor test,
pressure sensor test, expiratory valve test, or safety valve test has failed, and mechanical ventilation is
not allowed.
n Cancel: It indicates that all self-test items have been canceled, and other self-test items have successfully
passed the self-test.
5. During system self-test, on the right side of the current self-test item, the system prompts [running]. At
this time, select the [Skip] key, the system will immediately stop the inspection of this item, the self-test
result of this item will be displayed as [Cancel], and the next self-test item will be carried out at the same
time. Select the [Stop] key, the system will immediately stop the current self-test items and the remaining
self-test items, and display the self-test result as [Cancel].
6. After the O2 sensor test fails, the [O2 Concentration Calibration] key will be displayed. After pressing it,
the O2 concentration calibration menu can be opened and the O2 concentration calibration can be
performed.
7. After the self-test of all items is completed, select [Retry], and the system will perform another round of
self-test. Select [Exit], the system will exit the self-test and enter the standby interface.
8. Please make sure that all items of the ventilator [System Self-test] can pass.

Autonomous Respiration Function Test

1. Turn off the ventilator, keep the ventilator in a closed state, and wear a face mask to ensure smooth
autonomous respiration.
2. Turn on the ventilator, keep the ventilator in a standby state, and wear a face mask to ensure smooth
autonomous respiration.

Humidifier Performance Test

For the performance test of the humidifier, please refer to the humidifier user manual. Ensure that the
humidifier can work properly.

4-3
Inspection and Test

Alarm Test

Preparation before alarm test

1. Connect the analog lung to the patient end interface of the Y-connector.
2. Start the ventilator, select the [New Patient-Adult] key in the standby mode, and set the [Ventilation Type]
to [Invasive].
3. The ventilation parameters of the ventilator are set as follows (standard operating state):
n Ventilation mode: volume control/assisted ventilation mode;
n Tidal volume: 500 mL;
n RESP frequency: 10 bpm;
n Inspiratory time: 2.00 s, or inspiratory/expiratory ratio: 1:2;
n End-tidal positive pressure: 3 cmH2O;
n O2 concentration: 40 vol.%.
4. Set the ventilator to exit the standby state and enter the operating state.
5. Ensure that:
n The monitoring parameter data of the ventilator is displayed normally.
n Simulate the periodic inspiration and expiration of the lungs.

Attention

l In the absence of a special statement, the operating state of the ventilator mentioned in this
chapter is the standard operating state.

Battery in Use

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

2) After the system is started, disconnect the AC power.

3) Verify whether the [Battery in Use] alarm is triggered, and the ventilator is powered by the battery.

4) Reconnect AC Power Supply

5) Verify whether the alarm is reset automatically, and the ventilator is powered by AC Power supply.

Power Failure Alarm

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

2) After the system is started, disconnect the external power supply when the battery is fully charged.

3) When the ventilator is connected to test lung, the ventilation is normal.

4) For the ventilator equipped with 1 battery, the ventilation time is about 2 hours (For the ventilator equipped
4-4
Inspection and Test

with 2 batteries, the ventilation time is about 4 hours). When the battery capacity is running out, the Power
failure alarm [System DOWM. Connect Ext. Power.] will be triggered.

5) Reconnect External Power Supply

6) Verify whether the alarm is reset automatically, and the ventilator is powered by external power supply.

Paw Too High

1) After the ventilator system is started normally, connect the ventilator to test lung and start ventilation.

2) Set Paw high alarm limit to current Ppeak + 5cmH2O.

3) In the inspiratory phase, press hard on the test lung.

4) Verify whether the [Paw Too High] alarm is triggered, the respiratory cycle is in expiratory phase, and airway
pressure is reduced to PEEP value.

Paw Too Low

1) After the ventilator system starts normally, connect the ventilator to the splint lung and start ventilation.

2) Set Paw low alarm limit to current Ppeak + 5cmH2O.

3) Verify that the [Paw Too low] alarm is activated

TVe Too Low

1) After the ventilator system is started normally, connect the ventilator to test lung and start ventilation.

2) Set the TV low alarm limit to greater than current TVe, and verify whether the [TVe Too Low] alarm is
triggered.

TVe Too High

1) After the ventilator system is started normally, connect the ventilator to test lung and start ventilation.

2) Set the TV high alarm limit to less than current TVe, and verify whether the [TVe Too High] alarm is
triggered.

MV Too Low

1) After the ventilator system is started normally, connect the ventilator to artificial lung and start ventilation.

2) Set the MV low alarm limit to greater than current MV, and verify whether the [MV Too Low] alarm is
triggered.

4-5
Inspection and Test

MV Too High

1) After the ventilator system is started normally, connect the ventilator to the splint lung and start ventilation.

2) Set the MV High alarm limit to be less than the current minute ventilation, and verify that the alarm of [MV
Too High] is activated.

O2 Supply Failure

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

2) Turn on the ventilator, connect the ventilator to the splint lung, set the O2 to 40vol%, and start ventilation.

3) Turn off the high-pressure O2 supply, and verify whether the [O2 Supply Failure] alarm is triggered.

PEEP Too Low

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

Expiratory valve diaphragm

2) After the ventilator system is started normally, connect the ventilator to test lung and start ventilation.

3) Set PEEP to 5cmH2O and verify whether the [PEEP Too Low] alarm is triggered.

Airway Obstructed

1) After the ventilator system is started normally, connect the ventilator to test lung and set to pressure mode, and
start ventilation.

2) Disconnect the connection between Y-shaped tube and test lung, use leakage-test plug to block Y-pipe tube.

3) After several respiratory cycles, verify whether the [Airway Obstructed?] alarm is triggered.

4) Connect Y-pipe tube with test lung, and verify whether the alarm is reset automatically.

Note

4-6
Inspection and Test

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

Tube Disconnected

1) After the ventilator system is started normally, connect the ventilator to test lung and start ventilation.

2) Disconnect the test lung.

3) Verify whether the [Tube Disconnect?] alarm is triggered.

Apnea Alarm

1) After the ventilator system is started normally, connect the ventilator to artificial lung and set the ventilator to
Spontaneous Breathing mode. Ensure the Apnea spare ventilation is disabled.

2) Set [Tapnea] and wait.

3) Verify whether the [Apnea] alarm is triggered.

4) Press the artificial lung.

5) Verify whether the [Apnea] alarm is reset.

FiO2 Too High

1) Connect the ventilator to low-pressure O2 supply, and set the O2 supply type to low-pressure O2 supply.

2) Connect the ventilator to test lung, and start ventilation.

3) After ventilation is stable, set the FiO2 high alarm limit to less than current monitored value of oxygen
concentration.

4) Verify whether the [FiO2 Too High] high-priority alarm is triggered.

FiO2 Too Low

1) Connect the ventilator to high-pressure O2 supply, and set the O2 supply type to high-pressure O2 supply.

2) Connect the ventilator to test lung, and start ventilation.

3) After ventilation is stable, close the high-pressure O2 supply.

4) Verify whether the [FiO2 Too Low] high-priority alarm is triggered.

EtCO2 Too High

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

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

4-7
Inspection and Test

3) After CO2 is preheated, supply 3% ~ 7% CO2 standard gas to the sampling port of sidestream CO2 module or
the airway adapter of mainstream CO2 module, set the EtCO2 high alarm limit to be less than the concentration
of the standard gas.

4) Verify whether the [EtCO2 Too High] medium-priority alarm is triggered.

EtCO2 Too Low

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

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

3) After CO2 is preheated, supply 3% ~ 7% CO2 standard gas to the sampling port of sidestream CO2 module or
the airway adapter of mainstream CO2 module, set the EtCO2 low alarm limit to be greater than the
concentration of the standard gas.

4) Verify whether the [EtCO2 Too Low] medium-priority alarm is triggered.

SpO2 Too high

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

2) Connect the SpO2 probe, and set the SpO2 monitoring function on

3) Connect the SpO2 probe with finger, set the SpO2 high alarm limit at 20%, the high SpO2 alarm limit at 22%

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

SpO2 too low

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

6) Connect the SpO2 probe, and set the SpO2 monitoring function on

7) Connect the SpO2 probe with finger, set the SpO2 low alarm limit at 98%, the high SpO2 alarm limit at 100%

8) Pinch the finger with SpO2 probe, when the % SpO2 is lower than 98%, verify that the [SpO2 Too Low] alarm
condition is activated.

PR Too High

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

2) Connect the SpO2 probe, and set the SpO2 monitoring function on

3) Connect the SpO2 probe with index finger, set the PR high alarm limit at 30 bpm,

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

4-8
Inspection and Test

PR Too Low

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

2) Connect the SpO2 probe, and set the SpO2 monitoring function on

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

Ventilator Function Test

Checking the standard operating state

1. Turn on the power switch and the ventilator is in the standard operating state.
2. Ventilation mode: volume control/assisted ventilation mode;
3. Tidal volume: 500 mL;
4. RESP frequency: 10 bpm;
5. Inspiratory time: 2.00 s, or inspiratory/expiratory ratio: 1:2;
6. End-tidal positive pressure: 3 cmH2O;
7. O2 concentration: 40 vol.%.

Tidal volume inspection

1. After starting up and working, connect the analog lung, and after the tidal volume output stabilizes,
observe the tidal volume display in the monitoring area of the display screen.
2. Ensure that the tidal volume monitoring value display is stable, and the monitoring value is basically
consistent with the set value.

Trigger function inspection

1. Set the pressure trigger sensitivity to -2cmH2O, wear a mask and inhale gently. When the airway
pressure is slightly lower than this set value, inspiration starts, and at the same time, a trigger symbol
flashes in the information bar of the display screen.
2. Set the flow rate trigger sensitivity to 2l/min, wear a mask and inhale gently. When the trigger sensitivity
of the inspiratory flow rate is reached, inspiration starts, and at the same time, a trigger symbol flashes in
the information bar of the display screen.

Autonomous respiration inspection in CPAP/PSV mode

1. Set the ventilator to work in CPAP/PSV mode, set the flow rate trigger at 2l/min, the support pressure at
10cmH2O, and other parameters at default values.
2. Wear a mask and inhale gently. When the trigger sensitivity is reached, make sure that inspiration starts
4-9
Inspection and Test

and perform PSV ventilation.

Sidestream CO2 test

1. In the ventilation mode, after the CO2 preheating is completed, completely block the air intakes of the
module with your hands or other objects.
2. After being blocked for a period of time, the screen displays the alarm information of [CO2 sampling
tube is blocked], which proves that the module has no air leakage.
3. Put the sampling tube in front of the mouth to breathe, the CO2 waveform is generated on the waveform
interface, and the EtCO2 monitoring value is displayed under the monitoring interface.

Mainstream CO2 test

1. In the ventilation mode, after the CO2 preheating is completed,


2. Put the adapter in front of the mouth to breathe, the CO2 waveform is generated on the waveform
interface, and the EtCO2 monitoring value is displayed under the monitoring interface.

SpO2 test

1. Connect the ventilator and the analog lungs, and start ventilation.
2. Connect the SpO2 sensor and turn on the SpO2 monitoring function.
3. Connect the SpO2 sensor to finger, SpO2 waveform is generated on the waveform interface, and SpO2
and PR monitoring values are displayed under the monitoring interface.

Special function inspection

u Inspiration holding
1. Select the [Tool] key → [Function] →[Insp. Hold], and keep pressing the [Insp. Hold] key to
ensure that the ventilator enters the inspiration holding stage. When the [Insp. Hold] key is kept
pressed for more than 30 seconds, the ventilator will automatically terminate the inspiration holding
function.
2. Release the [Inspiration Holding] key to ensure that the ventilator enters the expiration stage.
u Expiration holding
1. Select the [Tool] key → [Function] → [Exp. Hold], and keep pressing the[Exp. Hold] key to
ensure that the ventilator enters the expiration holding stage. When the [Exp. Hold] key is kept
pressed for more than 30 seconds, the ventilator will automatically terminate the expiration holding
function.
2. Release the [Expiration Holding] key to ensure that the ventilator enters the inspiration stage.
u Oxygenation
1. When the ventilator is working, select the adult mode and press the [O2↑ Suction] key to ensure that
the ventilator delivers air according to the O2 concentration of 100%.
4-10
Inspection and Test

2. Press the [O2↑ Suction] key again or maintain the oxygenation function for 2 minutes to ensure that
it returns to the operating state before oxygenation.
u Sputum suction
1. Click the [O2↑ Suction] key to enter the sputum suction function. Make sure that the sputum suction
enters the first stage, that is, the system performs O2↑ ventilation on the patient.
2. Disconnect the patient tubing set to ensure that the sputum suction enters the second stage, that is,
the system stops ventilating the patient and prompts [Patient tube disconnected. Reconnect the
patient after completing sputum suction.].
3. Reconnect the patient tubing set to ensure that the intelligent sputum suction enters the third stage,
and perform O2↑ ventilation on the patient.
u Nebulizer
1. When the ventilator is working, press the [Nebulizer] key and set the [Time] in the menu that opens.
After the setting is complete, select the [OK] key to ensure that the ventilator enables the [Nebulizer]
function, and there is an airflow output at the atomization output port.
2. After reaching the atomization time, click the [Nebulizer] key again to ensure that the ventilator
terminates the [Nebulizer] function.
u Manual respiration
1. When the ventilator is working, select the [Tool] key → [Function] →[Manual Breath] to ensure
that the ventilator immediately performs a mechanical ventilation.
u Sigh function
1. When the ventilator is working, select the [More Parameters] key → [Sigh], and set the [Sigh] to
[ON] in the opened menu.
2. The ventilation parameters are the default values: [△int.PEEP] is 5cmH2O, [Sigh Interval] is 1min,
and [Sigh Cycle] is 3.
3. Select the [OK] key to ensure that the ventilator activates the sigh function every 1 minute, and each
activation of the sigh is effective for 3 consecutive ventilation cycles.

Electrical Safety Test

Attention

l After completing repairs or routine maintenance, electrical safety tests shall be performed.
Before the electrical safety test, all cover plates, panels and screws shall be installed correctly.

l It is recommended to entrust professional organizations or manufacturers to conduct electrical


safety tests. It is recommended to conduct an electrical safety test every year.

l Please use a certified safety analyzer (such as UL, CSA or AAMI, etc.) and perform relevant
tests in accordance with its operating instructions.

4-11
Inspection and Test

Electrical safety inspection test

1. Carry out the ground impedance test.


u Connect the two gauges of the safety analyzer’s test earth resistance to the protective earthing
terminal of the AC power cord and the O2 interface respectively.
u Use 25A test current to perform the protective earth resistance test.
u Verify that the impedance value does not exceed 0.1ohms (100mohms).
u If the resistance value exceeds 0.1ohms (100mohms) but less than 0.2ohms (200mohms), remove
the AC power cord, connect the gauge connected to the protective earthing terminal of AC power
cord to the protective earthing terminal of power socket, and repeat steps a) to c).
2. Carry out the earth leakage current test under the following conditions:
u Normal polarity
u Reverse polarity
u Open neutral, and normal polarity
u Open neutral, and reverse polarity
u Verify that the maximum leakage current does not exceed 500μA (0.5mA) for the first two cases,
and does not exceed 1000μA (1mA) for the latter two cases.
3. Carry out the patient leakage current test under the following conditions:
u Normal polarity
u Reverse polarity
u Open neutral, and normal polarity
u Open neutral, and reverse polarity
u Open earth, and normal polarity
u Open earth, and reverse polarity
u Mains on AP, and normal polarity
u Mains on AP, and reverse polarity
Verify that the maximum leakage current does not exceed 10μA (0.01mA) for Type CF applied parts and
100uA (0.1mA) for Type BF applied parts in the previous two cases; does not exceed 50μA (0.05mA) for
Type CF applied parts and 500uA (0.5mA) for Type BF applied parts in the middle four cases; does not
exceed 50μA (0.05mA) for Type CF applied parts and 5000uA (5mA) for Type BF applied parts in the last
two cases.

Attention

l Please use a certified safety analyzer (such as UL, CSA or AAMI, etc.) and perform relevant
tests in accordance with its operating instructions.

Electrical safety checklist

Testing site Tested by

4-12
Inspection and Test

Equipment under test Hospital control


number
Manufacturer Model Serial No.
Inspection equipment Serial No. Calibration date
Inspection and test Pass/Fail Limit
Protective earth resistance Ω Maximum:
1
0.1Ω
Earth leakage Normal state µA
2
current Single fault state µA
Patient leakage Normal state µA
3
current Single fault state µA
During routine maintenance, all testing items in the electrical safety checklist shall be performed. After
disassembling and maintenance, if the power board is maintained or replaced, perform all the testing items in
the electrical safety checklist; if the power board is not maintained or replaced, carry out the testing item 1
only.

4-13
Chapter 5 Maintenance Menu and Software
Upgrade

User Maintenance

Overview

This section introduces the user maintenance function. User maintenance is mainly used by equipment
maintenance personnel. The functions included include settings, default values, data transfer, interface settings,
and system information.
The user maintenance password can be obtained in the Chapter Foreword of the Manual.

User settings

Setting items Description of setting items


Language Set the interface display language
Unit Set the pressure unit, weight unit and CO2 unit
Set the O2 source type. The wrong setting of the gas source type may cause some functions
Gas Supply
(such as oxygenation, etc.) to be restricted.
Other Set the minimum alarm volume

5-1
Maintenance Menu and Software Upgrade

Default values

Adjust the settings of the ventilator according to actual needs, select [Use Current], and the default values
displayed in the menu form will be replaced with the current settings. When the ventilator receives a new
patient after it is turned on, the ventilator will automatically load the default values in the menu.
Select the [Restore Default] key to restore the default values in the menu to the manufacturer default values.
When the ventilator receives a new patient after it is turned on, the ventilator will automatically load the
default values in the menu.

Data transfer

When the ventilator is used in the department and requires multiple ventilators to be configured uniformly, it
is used to export or import the current settings and default values of the ventilator settings. The USB flash
drive used has more than 10M free space and is in FAT32 or FAT format.

Export settings

1) Insert the USB memory into USB connector of the ventilator.

5-2
Maintenance Menu and Software Upgrade

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

3) Select [Data Transfer] →[Setting] → [Export], save the current settings and default values in the ventilator to
the USB memory.

Import settings

1) Insert the USB memory into USB connector of the ventilator.

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

3) Select [Data Transfer] →[Setting] → [Import], load the settings in the USB memory to the ventilator.

Data export

1) Insert the USB memory into USB connector of the ventilator.

2) Select [Setup] → [Export] → [Export Data], the system will check whether the USB memory exists or not. If
the USB memory exists with enough free space, the system will export patient information, current set
parameter, current alarm limit, tabular trends, graphic trends, and the measured value of
PEEPi/P0.1/Vtrap/NIF, etc. The file format exported is html.

3) In addition to exporting the data above, if you need to export Event log, Self-test log and more, select [Setup]
→ [Maintain]→ input the User maintenance password → [Data Transfer] → [Data] → select data type to be
exported → [Export], the system will check whether the USB memory exists or not. If the USB memory exists
with enough free space, the system will export the data. The file format exported is html.

4) After the export is finished, select [Remove the USB memory] button to remove the USB memory.

Interface settings

Interface settings include: nurse call, network settings and wireless network.

Nurse call

Nurse Call function means when the alarms set by users are triggered, the ventilator can input signal to Nurse

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Maintenance Menu and Software Upgrade

Call System to call a nurse. The ventilator provides Nurse call interface, which can realize “Nurse Call”
function after connecting the ventilator with the Nurse call system of the hospital using the Nurse call cable
supplied with the device.
Nurse Call function will be triggered when the ventilator meets the following conditions.

n Nurse call function is [On].

n There are alarms which meet user's settings generated.

n The system is not [Alarm audio paused] or [Reset].

Setup steps for Nurse call:

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

2) Select [Interface]→ [Nurse Call].

3) Switch on/off

4) Select [Signal Type] to set the signal type of Nurse call:

n [Pulse]: Nurse call signal output is the pulse signal lasts 1s. When there are multiple alarms, only 1 pulse
signal will be output; when a new alarm is generated with the current alarm being not removed, a pulse
signal will be output again.

n [Continuous]: The Nurse call signal output lasts as long as the time the alarm exists, namely lasts from
the alarm happening to the alarm terminating.

5) Select [Contact Type] to set working mode for the relay of Nurse Call System to [Normally Closed] or
[Normally Open].

6) Select [Alarm Level] to set the alarm level in which the nurse call can be triggered. If no choice is made, any
alarm will not trigger the nurse call.

7) Select [Alarm Type] to set the alarm type which will trigger the Nurse call. If no choice is made, any alarm
will not trigger the nurse call.

Warning
l The nurse call function shall not be used as the main source of alarm notification. The audible
and visual alarm of the equipment must be combined with the patient’s clinical manifestations
and symptoms.

l To connect with the nurse call system of the hospital through the nurse call port, please use the
nurse call cable provided by our company, otherwise it may cause the machine to burn out and
cause electric shock.

l When using the nurse call function, the alarm signal of the ventilator itself shall be checked
regularly.

Network settings

The network interface is a multi-functional multiplexing interface, providing 100 BASE-TX Ethernet

5-4
Maintenance Menu and Software Upgrade

communication channel; supporting HL7 network communication protocol.


The setting method is as follows:

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

2) Select [Interface] → [LAN].

3) Turn on the [Network].

4) Set the [IP Adress], [Remote IP Adress], [Subnet Mask], [Gateway] and [Port].

System information

Version information

It can query the version information of the system software.

Configuration information

It can query the configuration information of the ventilator, such as ventilation mode and special functions.

Maintenance information

It can query the total operating time of the system, the system startup time, the last calibration time of the O2
sensor, the last calibration time of the flow sensor, the remaining time until the next turbine maintenance and
the last maintenance time.

Manufacturer Maintenance

Overview

Manufacturer maintenance is used in scenarios such as factory function configuration, equipment calibration,
and troubleshooting. The manufacturer maintenance menu includes factory settings, calibration, calibration

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Maintenance Menu and Software Upgrade

data, data monitoring, diagnostic testing, and event log functions. The manufacturer maintenance password is
available in the Chapter Foreword of the Manual.

Warning
l This menu can only be operated by engineers with service qualification granted by Comen,
otherwise the machine may not work normally.

Manufacturer settings

Overview

The manufacturer settings include settings, function activation, restoring factory settings and version
information.

Settings

The setting items and their descriptions are shown in the table below.
Setting items Instructions
Waveform export It can be set to on or off. It is used to enable or disable the waveform export function.
Gas correction mode It can be set to ATPD or BTPS.
Apnea reset It can be set to on or off.
Inspiratory/expiratory It can be set to on or off to enable or disable the inspiratory time or
ratio inspiratory/expiratory ratio switching function.
Custom parameters It contains two options: on and off. It is used to enable or disable the monitoring

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Maintenance Menu and Software Upgrade

parameter customization function of the waveform interface.


The CO2 module type needs to be set according to the actual configurations of the
CO2 module
machine, including four options: Comen, Respironics, Masimo, and none.
The SpO2 module type needs to be set according to the actual configurations of the
SpO2 module
machine, including four options: Comen, Masimo, Nellcor, and none.
SpO2 audio It can be set to three options: audio 1, audio 2, and none.
SpO2 tone It can be set to tone 1, and tone 2.
It can set the altitude, when the atmospheric pressure sensor fails, the atmospheric
Altitude
pressure can be calculated according to the altitude.
Altitude unit It can set the altitude unit, including two options: m and ft.
It can be set to OFF, 15s, 30s, 60s. When set to OFF, the focal spot will not be hidden
Automatic hidden of
automatically; when set to other options, the focal spot will automatically disappear if
focal spots
the duration of no operation reaches the corresponding time.
It can be set to OFF, 15s, 30s, 60s. When set to OFF, the menu will not be
Automatic hidden of
automatically hidden; when set to other options, the menu will be closed
menu
automatically if the duration of no operation reaches the corresponding time.
Turbine life It can set the service life of the turbine.
Clear the turbine After replacing the new turbine, click this key to clear the turbine running time. The
running time turbine running hours information is displayed next to the key.

Function activation

In the function activation menu, the paid configuration can be activated by the activation code or USB flash
drive, and the corresponding function can be tried out. For the specific operation method, please refer to 5.3.2
Function activation.

Restoring factory settings

Restoring factory settings refers to restoring the values of the setting items to the factory default values, and
the default values saved in the property page of the new patient default values will also be restored to the
factory default values.

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Maintenance Menu and Software Upgrade

Restoring factory settings will clear user logs and saved ring diagrams (including reference ring and P-V ring
diagrams), but not clear manufacturer logs.
The setting items that are not affected by restoring factory settings include inherent setting items, power-on
initialization items, menu initialization items, date and time items, language and factory settings.

The language setting items include:


Module Position Setting items
User Set Language
maintenance

Manufacturer setting items includes:


Module Position Setting items
Manufacturer Manufacturer settings Upgrade mode
maintenance Manufacturer settings Gas correction mode
Manufacturer settings Apnea reset
Manufacturer settings Custom parameters
Manufacturer settings Altitude
Manufacturer settings Altitude unit
Manufacturer settings Automatic hidden of focal spots
Manufacturer settings Automatic hidden of menu
Manufacturer settings Turbine life

Inherent setting items: The value of the setting item is not affected by setting transfer and restoring factory
settings.
Module Position Setting items

5-8
Maintenance Menu and Software Upgrade

Manufacturer Manufacturer settings CO2 type


maintenance Manufacturer settings SpO2 type
Manufacturer settings SpO2 audio
Manufacturer settings SpO2 tone
Function activation Checked status of default items in trial
Function activation Checked status of inactive presetting
items

Power-on initialization items: After each power-on, the factory default values are restored; without powering
off, each time you open the menu, the latest presetting item values will be kept.
Module Position Start initialization item
Atomization Atomization time
P-V tool Pstart
P-V tool Pmax
Special
P-V tool Flow
procedure
P-V tool Vlimit
P-V tool Historical ring diagram
P-V tool Reference ring diagram
Manufacturer calibration - Pressure calibration Calibration device
Manufacturer calibration - Expiratory valve
Calibration benchmark
Manufacturer calibration
maintenance Manufacturer settings Gas correction mode
Manufacturer settings Upgrade mode
Manufacturer settings Custom parameters
Interface Waveform interface
Waveform interface
layout

Enter the menu initialization item: After opening the menu each time, it is restored to the factory default
values.
Module Position Start initialization item
Diagnostic test Turbine speed
Diagnostic test Pressure
Diagnostic test Large-diameter inspiratory valve
Manufacturer Diagnostic test O2 proportional valve
maintenance Diagnostic test Expiratory valve
Diagnostic test Atomization valve
Diagnostic test Safety valve
Manufacturer settings - Function activation Activation code

Date and time setting items: It is neither initialized nor remains unchanged, and is displayed according to the

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Maintenance Menu and Software Upgrade

law of increasing time and date.


Module Position Start initialization item
Date/time Date
Time settings
Date/time Time

Version information

In this menu, you can refer to the software version information currently used by each module.

Manufacturer calibration

The manufacturer calibration menu provides the following entries: zero calibration, flow calibration, pressure
calibration, expiratory valve calibration, O2 concentration calibration and air-oxygen calibration. For
calibration steps, refer to Section 6.3 System calibration.

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Maintenance Menu and Software Upgrade

Calibration data

The calibration data menu includes zero point data monitoring, user calibration tables and manufacturer
calibration tables for each component, and air-oxygen calibration data display.

Data monitoring

The data monitoring menu includes VCM data monitoring, VPM data monitoring, and power panel data

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Maintenance Menu and Software Upgrade

monitoring.

Diagnostic test

Provide valve test settings. For details, refer to Section 7.6 Diagnostic test.

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Maintenance Menu and Software Upgrade

Event log

It can view event logs, including alarm logs, operation logs, error messages, and maintenance messages. It can
be viewed by selecting different event logs through a filter, which can be configured:
Setting items Functional description
High-level alarm Only all high-level alarm events are displayed.
Medium-level alarm Only all medium-level alarm events are displayed.
Low-level alarm Only all low-level alarm events are displayed.
All alarms Only all alarm events are displayed.
Operation information Only all operation events are displayed.
Only all error events are displayed (only in the manufacturer’s event log, not in
Error message
the user’s event log).
It includes maintenance operations such as zero calibration and self-test
Maintenance information
operations.
All events All events are displayed.

Software upgrade and software function activation

Caution
l Software upgrade and configuration activation can only be performed by professional
maintenance personnel with service qualification granted by Comen.

This ventilator can use a USB flash drive for software upgrades, and at the same time, it can activate software
functions for optional configurations supported by the software through the control of the activation code.

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Maintenance Menu and Software Upgrade

Before activating the optional configuration function, the user can try the optional configurations for a
maximum of 30 days through the function trial.

Upgrade of USB flash drive

This ventilator can use a USB flash drive to upgrade the following programs online:
u System software
u File system
u Boot software
u Linux kernel
u VCM software
u VPM software
u Key board software
u Power panel software

Caution
l Before upgrading, you must disconnect the ventilator from the patient and back up the
important data in the ventilator.

Attention
l Please make sure that the version of the upgrade package is what you need before upgrading.
To obtain the latest version of the program upgrade package, please contact our Product
After-sales Service Department.

l Before upgrading the system software, please check the boot software version. If you find that
it is not the latest version currently in force by our company, please first upgrade the boot
software to the latest version currently in force to ensure software upgrade compatibility.

Description for the upgrade of USB flash drive

1. Save the upgrade package and the configuration file with the same name to the SOFTUPDATE directory
of the USB flash drive.
2. Set the USB flash drive upgrade mode in the system software. Select [Setup] → [Maintain] → enter the
manufacturer maintenance password → [Setup] → [Upgrade], and select the content to be upgraded.
3. After the upgrade is complete, unplug the USB flash drive, restart the ventilator, and verify whether the
machine upgrade is complete.

Attention
l The file system format of the USB flash drive used for USB flash drive upgrade must be
FAT32. The remaining space of the USB flash drive before the upgrade is at least 100M to

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Maintenance Menu and Software Upgrade

ensure that the upgrade is successful.

l The folder where the upgrade package is stored can only be named SOFTUPDATE, all letters
are capitalized, and the upgrade package and configuration file can only be named rootfs.gz or
zImagedtb or u-boot.imx or VCM.bin or VPM.bin or POWERBOARD.bin and
KEYBOARD.bin.

l Upgrade a single VCM module upgrade package. After the upgrade is successful, the buzzer
will sound, which is a normal phenomenon. Just shut down and restart the machine.

Online upgrade of system software

1. Turn off the machine, then insert the USB flash drive with the system software upgrade program, turn it
on again, and the overall unit will perform automatic online upgrade of system software. After the screen
displays “Update finished”, the upgrade is successful.
2. Press and hold the on-off key for 15s to shut down; after shutting down, unplug the USB flash drive.
3. Press and hold the on-off key again, start the machine normally after 3s, and the online upgrade of
system software is completed.

Online upgrade of VCM software

1 The overall unit is in normal operation state, insert the USB flash drive with the VCM software upgrade
program, enter [Service]→ [Setup] → [Upgrade], and click VCM Upgrade:
Ø If it displays “Upgrading” after clicking, the screen will be automatically locked at this time. It is
normal for the buzzer to sound during the upgrade, just wait for the completion of the VCM
software upgrade.
2 After “Upgrade Successful” is displayed, unplug the USB flash drive and the VCM software upgrade is
complete.

Online upgrade of VPM software

1 The overall unit is in normal operation state, insert the USB flash drive with the VPM software upgrade
program, enter [Service]→ [Setup] → [Upgrade], and click VPM Upgrade:
Ø If it displays “Upgrading” after clicking, the screen will be automatically locked at this time. It is
normal that the screen will lose power for 5s during the upgrade, just wait for the completion of the
VPM software upgrade.
2 After “Upgrade Successful” is displayed, unplug the USB flash drive and the VPM software upgrade is
complete.

Online upgrade of key board software

1 The overall unit is in normal operation state, insert the USB flash drive with the key board software

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Maintenance Menu and Software Upgrade

upgrade program, enter [Service]→ [Setup] → [Upgrade], and click Key Board Upgrade:
Ø If it displays “Upgrading” after clicking, the screen will be automatically locked at this time. It is
normal that the screen will lose power for 5s during the upgrade, just wait for the completion of the
key board software upgrade.
2 After “Upgrade Successful” is displayed, unplug the USB flash drive and the key board software upgrade
is complete.

Online upgrade of power panel

1. The overall unit is in normal operation state, there is no communication abnormality between the power
panel and the upper computer, insert the USB flash drive with the upgrade program, enter [Service]→
[Setup] → [Upgrade], and click Power Panel Upgrade:
Ø If it displays “Upgrading” after clicking, wait for the overall unit to power off. After the overall unit
is powered off, unplug the USB flash drive and wait for the overall unit to restart automatically.
Ø If you click Power Panel Upgrade, it prompts “USB flash drive is not inserted or the upgrade file
does not exist”, you need to confirm whether there is an upgrade file in the USB flash drive, try to
unplug and reinsert.
Ø If the overall unit is powered on and “Upgrading” is displayed for a long time, you need to click the
power panel again to upgrade.
2. After the overall unit restarts automatically (after entering the logo interface, it is best to go to the
standby interface), reinsert the USB flash drive, enter the maintenance interface, enter [Service]→ [Setup]
→ [Upgrade], and click the Power Panel Upgrade again:
Ø If it displays “Upgrading” after clicking, the screen will be automatically locked at this time, and
just wait for the completion of the power panel upgrade.
Ø If you click Power Panel Upgrade, it prompts “USB flash drive is not inserted or the upgrade file
does not exist”, you need to confirm whether there is an upgrade file in the USB flash drive, try to
unplug and reinsert.
3. The power panel is successfully upgraded:
Ø If it displays that the upgrade is successful, the overall unit will shut down automatically after 5s.
After the machine automatically shuts down, unplug the USB flash drive and restart the machine to
complete the online upgrade of the power panel.
Ø If it displays that the upgrade failed, click the Power Panel Upgrade again to download.

Common problems and countermeasures of software upgrade

Common problems Cause Countermeasures


Unable to enter the USB The USB flash drive is not Insert the USB flash drive into the USB
flash drive upgrade, and inserted. interface of the ventilator.
directly enter the system The USB flash drive is Replace the non-faulty USB flash drive and
software after booting malfunctioning. try again.

5-16
Maintenance Menu and Software Upgrade

The USB interface of the The monitoring board is returned to the


ventilator is damaged. factory for maintenance.
The naming of the folder, upgrade
Modify the name of the folder, upgrade
package, or configuration file
package or configuration file.
does not meet the requirements.
USB flash drive upgrade
The upgrade package or Re-prepare the upgrade package and
failed
configuration file does not exist. configuration file.
The upgrade package or Re-prepare the upgrade package and
configuration file is incorrect. configuration file.
During the upgrade, the In the upgrade process, there may
buzzer on the main be an abnormal power failure or
control board will beep an abnormal failure of the The main control board is returned to the
for a long time (beep ...), upgrade process, resulting in factory for maintenance.
and the upgrade cannot damage to the BIOS program of
be performed. the main control board.
When the system
software is upgraded,
It is possible that the BIOS
you can enter the Contact Comen’s after-sales engineer to
version and the system software
upgrade screen, but the confirm version compatibility.
version are not compatible.
upgrade is always
unsuccessful.
The corresponding parameter
software module, IOS version and Contact Comen’s after-sales engineer to
module software version may not confirm version compatibility.
When the control module
be compatible.
is upgraded, you can
Check whether the version information of
enter the upgrade screen,
the ventilator includes the BIOS version
but the upgrade is always The corresponding parameter
information of the corresponding parameter
unsuccessful. software module BIOS may be
software module. If not, return to the factory
missing.
to upgrade the BIOS of the corresponding
parameter software module.
After upgrading the
system software or XX Reconfirm the XX module software version
The system software and the XX
module software, the and module code information. If the relevant
module software version do not
system reports that the information is correct, return the faulty
match or the module is damaged.
communication of XX module to the factory for maintenance.
module is stopped.

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Maintenance Menu and Software Upgrade

Function activation

The manufacturer can activate all the functions in the table below through activation codes. When the user
needs to add any function in the table below, the after-sales service engineer can place an order with the
manufacturer to purchase the activation code to activate the function.
Optional Impact on the software interface Remark
configurations
DuoVent
PRVC
PRVC-SIMV
Related menu items do not appear.
APRV
PSV-S/T
VS
P0.1
Related menu items do not appear. If all are not configured, the diagnostic
NIF
property page will not be displayed in the special program menu.
PEEPi
Related menu items do not appear. When the P-V tool function is not
PV tool configured, the P-V tool property page will not be displayed in the special
program menu.
Sputum The sputum suction key is not displayed in the soft key area on the right
Paid
suction side of the main interface.
configurations.
Related menu items do not appear. When the ATRC function is not
ATRC configured, the automatic intubation resistance compensation property
page will not be displayed in the parameter setting dialog box menu.
Respiratory
function This monitoring parameter is not displayed.
RSBI
SpO2 SpO2-related monitoring parameters and related menu items are not
monitoring displayed.
CO2 CO2-related monitoring parameters and related menu items are not
monitoring displayed.
CO2 CO2-related monitoring parameters are not displayed.
expansion
monitoring

Application for software function activation code

Attention

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Maintenance Menu and Software Upgrade

l To apply for an activation code, you must provide relevant information about the ventilator
that is ready to activate the configurations: machine ID, existing configurations, and
configurations to be activated.

l Each activation code can only activate one machine.

When a user needs to add the above paid configurations, the after-sales service engineer must place an order
to purchase the software function configuration activation code from our After-sales Service Department
according to the user’s needs. The specific steps are as follows:
1. Record the serial number of the ventilator that needs to be activated.
2. Record the machine ID of the ventilator and the current existing configuration information: Select [Setup]
→ [Maintain] → input the User maintenance password to enter the [User] menu → [Syst. Info] →
[Config Info.], and open the [Config Info.] menu:

3. Record the configuration information that the user needs to activate newly.
4. Return the information related to the above records to our After-sales Service Department, and purchase
the corresponding activation code.

Software function configuration activation process

Attention

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Maintenance Menu and Software Upgrade

l Before activation, please check and record the user’s existing paid configurations and the new
paid configurations that need to be added.

l After the activation code is entered, you should confirm that the activation code input is
consistent with the activation code provided by the manufacturer.

l Do not power off the ventilator before activating the dialog box prompting [Upgrade is
completed, please restart the machine], otherwise the BIOS program of the main control board
of the ventilator will be damaged.

l After prompting that the activation is successful, restart the ventilator to ensure that both the
existing paid configurations and the newly-added paid configurations are activated after the
upgrade; if the ventilator is not restarted, the activated new functions will not take effect
immediately.

Please follow the steps below to activate the software function configuration:
1. Unlock the configuration first: Select [Setup] → [Maintain] → [Service] → Enter the manufacturer
maintenance password → [Setup] → [Default] → [Unlock the configuration]
2. After successfully unlocking, the [SN] key appears under the [Setup] interface, select [SN], and enter the
SN code of the machine, which is provided by the manufacturer;
3. Open the [Activate] menu of the software: Select [Setup] → [Maintain] → [Service]→ Enter the
manufacturer maintenance password → [Setup] → [Activate], as shown in the figure below:

4. If you select [Activate], the system prompts: the activation file is loaded successfully, whether to
continue activation.
5. Click the [OK] key and restart the ventilator to make the newly activated configuration items take effect.

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Maintenance Menu and Software Upgrade

Common problems and countermeasures of software function activation

Common problems Cause Countermeasures


After activation,
restart the ventilator, During activation, the ventilator is powered off
and the main control or turned off without prompting that the The main control board is returned
board will beep for a activation is successful, causing damage to the to the factory for maintenance.
long time and cannot main control board BIOS.
be started.
Confirm that the activation code is
consistent with the activation code
provided by the manufacturer.
The system prompts If the activation code is entered
an invalid activation The activation code is entered incorrectly, or correctly but the activation code is
code and the system the activation code is wrong. prompted to be wrong, please send
cannot be activated. the machine ID, existing
configurations and new
configurations to the manufacturer
for reconfirmation.
Reconfirm the existing
After the system is
The manufacturer’s activation code is configurations and new
activated, the
generated incorrectly, or the existing configurations, confirm with the
activation function is
configuration and new configuration items manufacturer, and require the
inconsistent with the
provided to the manufacturer are incomplete. manufacturer to regenerate the
user configurations.
activation code.
Choose to import the
activation code, and it
The activation code file in the USB flash drive
prompts that the
is damaged, or the activation code file does not Re-apply for the activation code.
activation file cannot
exist in the USB flash drive.
be found, please try
again.
The system selects
the USB flash drive
The activation code file exists in the USB flash
to activate, and
drive, but the content of the file is incorrect and Re-apply for the activation code.
prompts that the
cannot be activated.
activation code file is
wrong.

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Maintenance Menu and Software Upgrade

Function trial

Support users to try optional configuration functions, the longest trial time is 30 days.
Please follow the steps below to try the paid functions:
In standby mode, select the [Setup] → [Maintain] →Enter the manufacturer maintenance password→
[Setup] → [Function Activation]. In the [Activation] menu, click the Function Trial key, and select the
function option that needs to be tried (multiple selections are available). Click the [OK] key, and the [Trial
Function] confirmation dialog box will pop up. After confirming, restart the machine to support the trial of the
paid function.
After the function trial starts, you can use the corresponding paid functions, and the trial period for each
function is up to 30 days. At the same time, you can end the trial of the function in advance by unchecking the
function currently in trial.
When the trial function expires, the trial of the corresponding trial function ends and the use of the function is
no longer supported. When a user continues to use this function, the after-sales service engineer can place an
order to purchase the software function configuration activation code from our After-sales Service Department
to activate the function.

Attention
l When starting a function trial, you must shut down and restart it for the trial function to take
effect.

l After the trial date is over, the corresponding functions cannot be used next time the machine
is turned on.

l Each paid function only supports one trial, and the trial period is up to 30 days.

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Chapter 6 Maintenance and Calibration

Warning
l When the machine needs to be inspected and maintained, it must be ensured that the patient is
disconnected from the machine.

l The machine may have been used on patients with infectious diseases. Please wear sterile
rubber gloves before testing or maintaining the machine to reduce the risk of infection.

l When there is blood or other secretions of the patient in the machine to be maintained, please
strictly follow the infectious disease control and safe treatment procedures for cleaning,
sterilization and disinfection.

Equipment Maintenance

In order to better ensure the long-term reliability and stability of the ventilator, the ventilator must be regularly
maintained and the parts must be replaced by authorized professional maintenance personnel. For the process
of replacing parts, please refer to Chapter 8 Maintenance and Disassembly. The regular replacement time of
equipment parts is one year. If you have replaced parts before, please keep a record. The lithium battery and
turbine box components need to be maintained according to the working hours. If the maximum working time
is reached or the system displays an alarm, the parts need to be replaced.

Attention
l This schedule is the minimum maintenance frequency specified with 5000 hours of use per year
as a typical situation. If the actual use time per year is longer than the typical situation, your
equipment shall be maintained more frequently.

l After the expiration of the parts that need to be replaced regularly, even if there is no wear or
damage, they must be replaced with new parts to avoid equipment damage or personal injury.

l Before performing maintenance on the ventilator, use the system self-test function of the
ventilator to detect the condition of important components such as turbine, sensor and valve.
At the same time, detecting the air leakage and blockage of the circuit can enable the operator
to have a preliminary understanding of the current status of the ventilator. Participate in 6.2.1
System self-test.

One-year replacement parts

One-year maintenance list and tools:

6-1
Maintenance and Calibration

Serial
Material code Description Quantity Tools
No.
1. 049-001523-00 Expiratory valve diaphragm 1 None
2. 115-007015-00 Filter box component 1 None
3. 045-000717-00 Dust screen at the air inlet 1 None
4. 045-000789-00 Fan dust screen 1 None
5. 082-00000049-00 Pressure sensor filter 2 Phillips screwdriver

Replacement parts

1. As required, replace the expiratory valve diaphragm every 12 months: According to the screen printing
instructions of the expiratory valve handwheel on the front panel of the main unit, turn the expiratory
valve handwheel counterclockwise to the limit position and take out the expiratory valve horizontally, as
shown in the figure below. Remove the expiratory valve diaphragm at the rear with bare hands and
replace it with a new maintenance accessory. During the replacement process, you need to be careful not
to damage the diaphragm, and make sure that the periphery of the diaphragm is evenly locked into the
annular groove of the expiratory valve plastic part.

Expiratory valve
diaphragm
(049-001523-00)

2. As required, replace the filter box component every 12 months: Remove the baffle at the air inlet of the
main unit, press and hold the top buckle of the filter box component with your hand and drag it out
horizontally. When installing, push the filter box component into the installation position and press it
tightly to confirm that the upper buckle is installed in place.
3. As required, replace the dust screen at the air inlet every 12 months: Remove the baffle at the air inlet of
the main unit, remove the dust screen at the air inlet with bare hands and replace it with a new
maintenance spare part.
4. As required, replace the fan dust screen every 12 months: Remove the rear shell of the main unit, remove
the fan dust screen with bare hands and replace it with a new maintenance spare part.
5. As required, replace the small filter at the purge branch of the expiratory flow sensor every 12 months:
Remove the top cover, display screen and front panel of the main unit, you can see the two pressure
6-2
Maintenance and Calibration

sensor filters as shown in the figure. Refer to the figure below to replace a new pressure sensor filter.

Ventilator inspection and test

Every 12 months, inspections and tests are required after the replacement of the maintenance kit. For details,
please refer to Chapter 4 Inspection and Test and 6.3 System calibration.

Regular maintenance parts

Serial No. Material code Description Quantity Tools


Replace it after 2 years or when the system
1. 022-000203 Lithium battery 1 or 2
prompts a “battery failure” alarm.
The turbine has been working for 20000
Turbine box
2. 115-007014-00 1 hours or the system appears the prompt
component
message of “turbine needs maintenance”.

System Detection

After the calibration and maintenance of the ventilator on the client side, some routine tests are generally
required to check and confirm whether the current state of the machine is normal. The following table is an
introduction to some conventional test items.
Serial Test item Functional description Test interval
No.
1. Detect whether the turbine, inspiratory flow sensor, O2 flow
After each
sensor, expiratory flow sensor, pressure sensor, expiratory valve and
maintenance
1. System self-test safety valve, and O2 concentration sensor work normally;
or during a
2. Detect the leakage, compliance and pipeline resistance of the
return visit
system.
1. Detect whether the machine normally provides mechanical After each
Mechanical
ventilation, and whether there is any abnormal alarm. maintenance
2. ventilation
2. Detect whether the measured value of machine pressure or tidal or during a
status detection
volume is consistent with the corresponding set value. return visit
Check the Detect whether the zero points of all flow sensors and pressure After each
correctness of sensors inside the machine are within the normal range, so as to maintenance
3.
the sensor zero determine whether it is necessary to perform zero calibration or or during a
point replace the monitoring board card. return visit
Flow sensor 1. Detect whether the measurement between the internal flow After each
measurement sensors of the machine is consistent; maintenance
4.
accuracy 2. Detect whether the measurement of any single flow sensor on the or during a
detection machine is accurate; return visit

6-3
Maintenance and Calibration

3. Detect the validity of the results of the flow calibration


(manufacturer).
1. Detect whether the measurement between the internal pressure
Pressure sensor sensors of the machine is consistent; After each
measurement 2. Detect whether the measurement of any single pressure sensor on maintenance
5.
accuracy the machine is accurate; or during a
detection 3. Detect the validity of the results of the pressure calibration return visit
(manufacturer).

System self-test

Attention
l Before performing maintenance on the ventilator, use the system self-test function of the
ventilator to detect the condition of important components such as turbine, sensor and valve.
At the same time, detecting the air leakage and blockage of the circuit can enable the operator
to have a preliminary understanding of the current status of the ventilator.

The system self-test includes detecting the working status of the turbine, O2 proportional valve, inspiratory
flow sensor, O2 flow sensor, expiratory flow sensor, pressure sensor, expiratory valve and safety valve, and
O2 concentration sensor, as well as reflecting the leakage and resistance of the machine. The test items are
shown in the following table:
Serial Calibration Functional description Test pass conditions
No. item
The deviation between the monitored actual
1. Turbine test Test the speed of the turbine. turbine speed and the control speed is less
than ±10% of the control speed.
The valve opening flow rate error between the
O2 flow sensor Test the O2 proportional valve O2 flow sensor and the O2 proportional valve
2.
test and O2 flow sensor. is less than max (2 l/min, ±30% of the test
flow rate).
The valve opening flow rate error between the
Inspiratory Test the inspiratory valve and inspiratory flow sensor and the inspiratory
3.
flow sensor test inspiratory flow sensor. valve is less than max (2 l/min, ±30% of the
test flow rate).
The error between the expiratory flow sensor
Expiratory flow
4. Test the expiratory flow sensor. and the inspiratory flow sensor is less than
sensor test
max (2 l/min, ±30% of the test flow rate).
Pressure sensor Test the inspiratory pressure Seal the expiratory valve with different
5.
test sensor and expiratory pressure pressures, the monotonicity of the readings of

6-4
Maintenance and Calibration

sensor. the inspiratory pressure sensor and the


expiratory pressure sensor is consistent with
that of the valve opening pressure, and the
deviation of the measured values of the
inspiratory pressure sensor and the expiratory
pressure sensor shall not exceed 10cmH2O.
Same as above, and add a judgment condition:
The auxiliary module controls to open the
Expiratory expiratory valve. At this time, the readings of
6. Test the expiratory valve.
valve test the inspiratory pressure sensor and the
expiratory pressure sensor are both less than
10 cmH2O.
Both the monitoring board and the auxiliary
Safety valve Test that the safety valve can be
7. monitoring board can normally control the
test opened and closed normally.
opening and closing of the safety valve.
The leakage when the airway pressure is
50cmH2O, the leakage is acceptable within
8. Leakage Calculate the tubing set leakage. the range of 0~200ml/min. The maximum
range that the machine can monitor is between
0 and 10 l/min.
Calculate the tubing set The compliance measured value is between 0
9. Compliance
compliance. and 20 ml/cmH2O.
Calculate the tubing set
Pipeline When the flow rate is 60l/min, the pipeline
10. resistance, and reflect whether the
resistance resistance is between 0 and 20 cmH2O/L/s.
tubing set is blocked.
In a pure air environment, the measured value
is between 18% and 23%; in a pure oxygen
11. O2 sensor test Test the O2 sensor.
environment, the measured value is between
90% and 100%.

Attention
l If the system self-test fails, please troubleshoot each failed detection item. For details, please
refer to Chapter 7 Troubleshooting, and then perform system self-test again until it is normal.

Mechanical ventilation status detection

Attention

6-5
Maintenance and Calibration

l The main function of the ventilator is to provide patients with respiratory support that meets
the doctor’s settings, i.e., mechanical ventilation. The test purpose in this section is to ensure
that the machine can complete normal mechanical ventilation.

l This inspection can comprehensively determine whether the machine can be used normally.

This detection item is mainly to check whether the machine setting value is consistent with the measured
value, whether the machine is working normally, whether there is an abnormal alarm, and it can
comprehensively determine whether the machine can be used normally.

Volume control ventilation detection

This detection item is used to comprehensively judge whether the machine can provide volume control
ventilation normally, including whether the control, feedback and measurement of tidal volume are normal;
whether the machine has a ventilation failure alarm.
Please follow the operations below to detect the volume control ventilation:
1. Make sure that the gas source pressure is normal, the tubing set connection of the RESP circuit is
correctly connected in accordance with the connection method that provides mechanical ventilation for
the patient, and the Y-connector of the patient circuit is connected to the 2 L skin as the analog lungs.
2. Select and confirm that the ventilation mode is V-A/C mode.
3. Set the following tidal volume TV and RESP frequency f combinations (150 mL, 15 bpm), (300 mL, 15
bpm), (600 mL, 15 bpm), and (900 mL, 15 bpm), other settings follow the default settings, and record the
TVi display value of each setting in a stable state respectively.
4. Respectively judge whether the above various measurement data meet the following conditions:
n The tidal volume control and measurement are normal: The error between the TVi display value and
the set value shall not exceed (10 mL + 10% of the set value).
n No other ventilation failures are generated: There is no obvious abnormality in the pressure
waveform and flow rate waveform, and no technical alarm occurs.
If the above test requirements are not met, please carry out follow-up related inspections and retest afterwards.

Attention
l If the ventilation detection of the volume control ventilation mode (V-A/C) is found to be
abnormal, please troubleshoot based on the abnormal phenomenon. For details, please refer to
Chapter 7 Troubleshooting, and then repeat the test until it is normal.

Pressure control ventilation detection

This detection item is used to comprehensively judge whether the machine can provide pressure control
ventilation normally, including whether the control, feedback and measurement of pressure are normal;
whether the machine has a ventilation failure alarm.
Please follow the operations below to detect the pressure control ventilation:
1. Make sure that the gas source pressure is normal, the tubing set connection of the RESP circuit is
6-6
Maintenance and Calibration

correctly connected in accordance with the connection method that provides mechanical ventilation for
the patient, and the Y-connector of the patient circuit is connected to the 2 L skin as the analog lungs.
2. Select and confirm that the ventilation mode is P-A/C mode.
3. Set the following inspiratory pressure control levels △Pisnp, RESP frequency f and PEEP parameter
combinations respectively: (10 cmH2O, 15 bpm, OFF), (15 cmH2O, 12 bpm, 5 cmH2O), and (20
cmH2O, 10 bpm, 8 cmH2O), other settings follow the default settings, and record the peak pressure
Ppeak display value and PEEP display value of each setting in a stable state respectively.
4. Respectively judge whether the above groups of measurement data meet the following conditions:
n Pressure control and measurement are normal: The difference between the Ppeak display value and
the inspiratory pressure set value (△Pisnp + PEEP) does not exceed (2 cmH2O + 5% of the set
value); the difference between the PEEP display value and the PEEP set value does not exceed (2
cmH2O + 5% of the set value);
n No other ventilation failures are generated: There is no obvious abnormality in the pressure
waveform and flow rate waveform, and no technical alarm occurs.
If the above test requirements are not met, please carry out follow-up related inspections and tests and retest
afterwards.

Attention
l If the ventilation detection of the pressure control ventilation mode (P-A/C) is found to be
abnormal, please troubleshoot based on the abnormal phenomenon. For details, please refer to
Chapter 7 Troubleshooting, and then repeat the test until it is normal.

Sensor zero point correctness detection

Attention
l The AD value at the zero point of the pressure sensor is abnormal. In the ventilation state
where PEEP is set to 0, it will appear that the baseline of the pressure waveform is not at the
zero point.

l The AD value at the zero point of the expiratory flow sensor or the zero point value of the
inspiratory flow sensor is abnormal. In the ventilation state, it will appear that the baseline of
the flow rate waveform is not at the zero point.

l The zero point value of the sensor exceeds the normal range and cannot be restored to normal
through zero calibration. The monitoring module board card must be replaced.

l The normal range of the zero point AD of the inspiratory pressure sensor and expiratory
pressure sensor: 967~1875.

l The normal range of the zero point AD of the expiratory flow rate sensor: 150~330.

l The normal range of the zero point of the inspiratory flow sensor and the O2 flow sensor:

6-7
Maintenance and Calibration

-0.5~1 l/min.

This detection item is mainly to detect whether the zero points of all flow sensors and pressure sensors inside
the machine are in the normal range, so as to determine whether it is necessary to perform zero calibration or
replace the monitoring board card.
You can detect the correctness of the sensor zero point according to the following steps:
1. Disconnect all gas sources and keep the Y-connector of the patient circuit facing the atmosphere.
2. Make sure the machine is in the standby state, select the [Main Menu] key → [Maintain] → enter the
manufacturer maintenance password → [Data Monitoring], select [VCM] and [VPM] respectively, and
observe the actual values of each flow and pressure sensor.
3. Ensure that the actual value measured by each sensor is close to 0 (if the actual value measured by a
sensor is greater than 0.5 at this time, the sensor needs to be performed with zero calibration). Record the
zero point value of each sensor and determine whether the zero point is within the normal range. If it is
not within the normal range, zero calibration is required. For the zero calibration method, please refer to
the introduction of 6.3.9 Pressure and flow zero calibration (manufacturer).

Flow sensor measurement accuracy detection

Attention
l When the deviation of tidal volume measurement is found to be large, please detect the
measurement accuracy of the expiratory flow sensor to determine whether it is necessary to
perform flow calibration again. This detection can also be used to confirm the effectiveness of
flow calibration.

This detection item is mainly to check whether the measurement between the internal flow sensors of the
machine is consistent, check whether the measurement of any single flow sensor in the machine is accurate,
and check the validity of the results of the flow calibration (manufacturer).
You can check the measurement accuracy of the flow sensor according to the following steps:
1. Connect the inspiration and expiration interfaces of the ventilator with a bellows, as shown in the figure
below:

6-8
Maintenance and Calibration

2. In the standby state, select the [Setup] key → [Maintain] → enter the manufacturer maintenance
password → [Diagnosis] to enter the [Valve Testing] menu.
3. First set the turbine pressure to 80cmH2O, and then set the flow rate of the inspiratory valve to change
from small to large. The valve opening flow rates are within the following ranges respectively:
(3±0.5)l/min, (10±1)l/min, (20± 1) l/min, (30±2)l/min, and (60±3)l/min. Record the flow rate measured
values of the corresponding total branch flow sensor and expiratory sensor in the steady state at each set
point. Determine whether the above measurement data meets the requirements: The error of the measured
values of the expiratory flow sensor and the total branch flow sensor shall be less than max (2l/min, the
measured value of the total branch flow sensor × 10%).
4. Connect the high-pressure O2 source, and the gas source is sufficient, and then set the flow rate of the O2
proportional valve to change from small to large. The valve opening flow rates are within the following
ranges respectively: (3±0.5)l/min, (10±1)l/min, (20±1)l/min, (30±2)l/min, and (60±3)l/min. Record the
corresponding measured value of the O2 flow sensor in the steady state at each set point. Determine
whether the above measurement data meets the requirements: The error of the measured values of the O2
proportional valve and the O2 flow sensor shall be less than max (2l/min, the measured value of the O2
flow sensor × 20%).
5. If the accuracy requirements are not met, please refer to 6.3.2 Flow calibration (manufacturer) to
perform flow calibration again. If the detection item fails to pass through the calibration, you need to
replace the corresponding flow sensor.

Pressure sensor measurement accuracy detection

Attention
l When the pressure measurement deviation is found to be large, please detect the measurement
accuracy of the pressure sensor to determine whether it is necessary to perform pressure
calibration again. This detection can also be used to confirm the effectiveness of pressure
calibration.

6-9
Maintenance and Calibration

This detection item is mainly to check whether the measurement between the internal pressure sensors of the
machine is consistent, check whether the measurement of any single pressure sensor in the machine is
accurate, and check the validity of the results of the pressure calibration (manufacturer).
You can check the measurement accuracy of the pressure sensor according to the following steps:
1. Make sure that the connection mode of the pressure sampling tube and the calibration device (or other
pressure measurement settings) is in the “parallel” state, use the pressure sampling tube to connect the
Luer connector to the “+” terminal of the VT Plus or PF-300 low-pressure port, as shown in the figure
below.

2. In the standby state, select the [Setup] key → [Maintain] → enter the manufacturer maintenance
password → [Diagnosis] to enter the [Valve Testing] menu.
3. The turbine pressure is set to 80 cmH2O, and the opening flow rate of the inspiratory valve is 10 l/min.
4. Set the pressure of the expiratory valve to change from small to large, and the valve closing pressure of
the expiratory valve is within the following ranges: (5±1) cmH2O, (20±1) cmH2O, (50±1) cmH2O, and
(70±2) cmH2O. At the same time, the measured values of the corresponding calibration device,
expiratory pressure sensor and inspiratory pressure sensor are recorded in the steady state at each set
point respectively.
5. Make sure that the above groups of measurement data must meet the requirements: The error between the
measured values of the expiratory pressure sensor and the inspiratory pressure sensor and the calibration
device shall be less than max (1cmH2O, the measured value of the calibration device × 4%). Otherwise,
please refer to the steps of 6.3.10 Pressure calibration (manufacturer) and 6.3.11 Expiratory valve
calibration (manufacturer) for recalibration. If the detection item fails to pass through the calibration,
you need to replace the corresponding pressure sensor.
6. Under the conditions that meet the requirements in the previous step, further ensure that the above groups
of measurement data must meet the requirements: The error between the expiratory valve and the

6-10
Maintenance and Calibration

calibration device (or expiratory/inspiratory pressure sensor) shall be less than max (5cmH2O, valve
opening set value × 20%). Otherwise, please refer to the steps of 6.3.11 Expiratory valve calibration
(manufacturer) for recalibration. If the detection item fails to pass through the calibration, you need to
replace the expiratory valve.

System Calibration

Attention
l When performing each system detection item described in 5.2 System Detection on the
machine, if any test item is found to fail, please perform the corresponding calibration items
provided in this section.

l After replacing the monitoring board card, valve or sensor of the machine, please execute the
corresponding calibration items provided in this section.

This ventilator can provide monitoring functions such as flow rate, pressure, volume, and inspiratory O2
concentration. The large measurement deviation of these monitoring values is likely to be related to the
deviation of the measured value of the related measurement component, and it generally needs to be
recalibrated. When the machine is maintained, such as the replacement of the monitoring board card, the
replacement of the valve, or the replacement of the sensor, it is necessary to recalibrate the flow sensor or
pressure sensor of the machine.
The following table lists the items that may need to be calibrated for this ventilator and the timing of the
calibration:
Serial Calibration item Functional description Calibration timing
No.
1. After the flow sensor has been used for a long
time, the measured value of the flow sensor has
Flow calibration Calibrate the expiratory deviation, which causes a large difference between
1.
(user) flow sensor TVi and TVe, for example, the deviation exceeds
(10ml + 10% of the set value);
2. Replace the expiratory flow sensor.
1. The deviation between the inspiratory flow
Calibrate the expiratory
sensor and the expiratory flow sensor exceeds 10%
flow sensor,
Flow calibration of its reading or 2l/min, whichever is greater;
2. large-diameter
(manufacturer) 2. Replace the inspiratory valve, TSI flow sensor or
inspiratory valve, and
monitoring board card, O2 proportional valve,
O2 proportional valve.
sensor board, etc.

6-11
Maintenance and Calibration

1. The measurement deviation of the O2 sensor is


Calibrate the
large: In the air, the measured value deviates from
measurement accuracy
O2 concentration 21% by more than 3%; in pure oxygen, the
3. of the 21% and 100%
calibration (user) measured value deviates from 100% by more than
concentrations of the
3%;
O2 battery.
2. Replace the O2 sensor.
1. The measurement deviation of the O2 sensor is
Calibrate the large: In the air, the measured value deviates from
O2 concentration measurement accuracy 21% by more than 3%; in pure oxygen, the
4. calibration of the 21% and 100% measured value deviates from 100% by more than
(manufacturer) concentrations of the 3%;
O2 battery. 2. Replace the O2 sensor;
3. Replace the monitoring board card.
1. When replacing the adapter;
2. When reconnecting the sensor to the module;
3. When the sensor is not in the best measurement
Mainstream CO2 Calibrate the zero point
state, the ventilator will prompt [CO2 requires zero
5. zero calibration deviation of the CO2
calibration]. At this time, please check the gas
(user) module.
circuit adapter to ensure that the adapter window is
not blocked, such as mucus. If a blockage is found,
the adapter needs to be cleaned or replaced.
The zero point deviation of the CO2 module is
manifested as the phenomenon that the waveform
Sidestream CO2 Calibrate the zero point deviates from the baseline after the CO2 module
6. zero calibration deviation of the CO2 sampling tubing set is placed in the atmosphere
(user) module. until the measured value is stable. It is
recommended to perform CO2 zero calibration
after the CO2 module has zero point deviation.
Calibrate the zero point When the pressure or flow rate waveform deviates
deviation of the from the baseline
pressure sensor and the
Pressure and flow
flow sensor. (You can
7. zero calibration
see the specific zero
(manufacturer)
point value in the
manufacturer
calibration menu).

6-12
Maintenance and Calibration

Calibrate the zero point When the pressure or flow rate waveform deviates
Pressure and flow
deviation of the from the baseline.
8. zero calibration
pressure sensor and the
(user)
flow sensor
1. The deviation between the measured value of the
Calibrate the inspiratory
machine pressure sensor and the standard pressure
pressure sensor,
Pressure calibration gauge exceeds 2% of its reading or 1 cmH2O,
9. expiratory pressure
(manufacturer) whichever is greater;
sensor, and expiratory
2. Replace the expiratory valve or sensor board;
valve.
3. Replace the monitoring board card.
1. The deviation between the control value of the
machine’s expiratory valve and the measurement of
the standard pressure gauge (or the machine’s
inspiratory/expiratory pressure sensor) exceeds
After completing the 20% of its reading or 5cmH2O, whichever is
Expiratory valve
pressure calibration, greater;
10. calibration
further calibrate the 2. Replace the expiratory valve or sensor board,
(manufacturer)
expiratory valve. perform pressure calibration, and then perform
expiratory valve calibration;
3. Replace the monitoring board card, perform
pressure calibration, and then perform expiratory
valve calibration.
1. After the O2 concentration calibration is
completed, the measurement deviation of the O2
Calibrate the coefficient
sensor is still large: In the air, the measured value
Air-oxygen between the measured
deviates from 21% by more than 3%; in pure
11. calibration values of the air flow
oxygen, the measured value deviates from 100%
(manufacturer) sensor and the O2 flow
by more than 3%;
sensor.
2. After replacing the inspiratory flow sensor or O2
flow sensor.

Flow calibration (user)

Attention
l The flow sensor is affected by the environment in which it is used. After a long period of use, a
large measurement deviation may occur, resulting in deviations in the tidal volume control.

l At this time, after-sales engineers can generally guide users through the phone to perform flow
calibration to solve the problem of large deviations.

6-13
Maintenance and Calibration

l After replacing the flow sensor, perform flow calibration again.

l Before calibrating, please perform system leak detection and make sure that the test passes and
there is no leakage in the tubing set.

l In the calibration process, make sure that the ventilator is connected to a high-pressure O2
source and the gas source is sufficient, otherwise the calibration may fail.

l Before calibration, it is recommended to disconnect the ventilator from the humidifier.

l It is recommended to use adult tubing sets for calibration.

This calibration item uses the ventilator’s own inspiratory flow sensor and O2 flow sensor as detection
equipment to calibrate the expiratory flow sensor.
When the flow sensor is used for several months, such as 3 months after calibration, the tidal volume
measurement error will be relatively large due to sensor aging or certain environmental factors (more than
10% difference from the set value); or if the user replaces the flow sensor, the flow sensor needs to be
recalibrated at this time. In this case, user-side flow calibration can generally be used.
The specific operation steps of this calibration item are as follows:
1. Select the [Setup] key → [Calibration], enter the [Calibration] menu, and select [Flow Cal.].
2. Connect the high-pressure O2 source and confirm that the gas source is sufficient.
3. Connect the RESP tubing set and insert the Y-shaped tee into the leak detection plug to seal the RESP gas
circuit.
4. Press the [Start] key to start user flow calibration.

Attention
l When the large measurement deviation of the expiratory flow sensor cannot be corrected by
repeatedly using this calibration, the user can be advised to perform the calibration after
replacing the flow sensor. If the fault persists, it is necessary to consider the need to perform
manufacturer maintenance on the machine, confirm and repair the fault, and then perform the
corresponding calibration.

Flow calibration (manufacturer)

Attention
l After replacing the monitoring module main board, sensor adapter board, O2 proportional
valve or inspiratory valve, you need to perform flow calibration (manufacturer).

l When it is found that there is a large deviation between the measured values of the expiratory
flow sensor and the calibration device (greater than 2l/min and 10% of the measured value of
the calibration device), it is necessary to perform flow calibration (manufacturer).

l When the altitude condition of the ventilator changes, please change the altitude set value in

6-14
Maintenance and Calibration

the manufacturer setting menu, and then perform flow calibration (manufacturer).

l Before calibration, it is recommended to disconnect the ventilator from the humidifier.

l It is recommended to use adult tubing sets for calibration.

This calibration item uses the ventilator’s own inspiratory flow sensor and O2 flow sensor as standard
equipment to calibrate the expiratory flow sensor, inspiratory valve, and O2 proportional valve.

Operation steps of flow calibration (manufacturer)

Attention
l Before calibrating, please perform system leak detection and make sure that the test passes and
there is no leakage in the tubing set.

l Before calibration, please ensure that no technical alarms such as sensor, valve or branch faults
have occurred.

l In the calibration process, make sure that the ventilator is connected to a high-pressure O2
source and the gas source is sufficient, otherwise the calibration may fail.

l In the calibration process, do not move or squeeze the tubing set.

The specific operation steps of this calibration item are as follows:


1. Select the [Setup] key → [Maintain] → enter the manufacturer maintenance password, enter the [Service]
menu, select [Calibration] → [Flow Cal.] → [Large-Diameter Insp. Valve] item.
2. Connect the high-pressure O2 source and confirm that the gas source is sufficient.
3. Connect the RESP tubing set and insert the Y-shaped tee into the leak detection plug to seal the RESP gas
circuit (see the figure below).

6-15
Maintenance and Calibration

4. Press the [Start] key to start the calibration of the manufacturer’s large-diameter inspiratory valve.
5. Select the[Setup] key → [Maintain] → enter the manufacturer maintenance password, enter the [Service]
menu, select [Calibration] → [Flow Cal.] → [O2 Valve] item, and repeat steps 2), 3) and 4) .
6. Select the[Setup] key → [Maintain] → enter the manufacturer maintenance password, enter the [Service]
menu, select [Calibration] → [Flow Cal.] → [Exp. Flow Sensor] item, and repeat steps 2), 3) and 4).

Attention
l After the flow calibration, please detect the measurement accuracy of the flow sensor. For the
detection steps, please refer to the description in Section 6.2.4 Flow sensor measurement
accuracy detection.

l If the calibration fails, please troubleshoot and fix the fault first, and then perform the flow
calibration again.

Error codes and countermeasures of flow calibration function

Error code Trigger cause Countermeasures


The pressures in the calibration table of
the turbine pressure sensor, expiratory
Failure prompt message pressure sensor, and inspiratory pressure Replace the expiratory valve and
number [3] sensor are not monotonous: If the inspiratory valve
expiratory valve is sealed with a larger
current, the pressure measured by the

6-16
Maintenance and Calibration

calibration equipment is lower.


Failure prompt message The set flow differs greatly from the Check whether there is any
number [5] actual flow. leakage during calibration
Failure prompt message
EEPROM read and write error. Recalibrate after restarting
number [10]
Failure prompt message The AD value of the differential pressure
Replace the expiratory flow sensor
number [20] flow sensor is less than 150.
Failure prompt message The AD value of the differential pressure
Replace the expiratory flow sensor
number [21] flow sensor is greater than 3700.
Failure prompt message The airway pressure is greater than Check whether the pipeline is
number [22] 50cmH2O. blocked

O2% calibration (user)

Attention
l When the error of the O2 concentration monitoring value is large, the O2 sensor calibration is
required.

l Before calibration, under the measurement interface, observe whether FiO2 can display the
value. If not, confirm that the O2 concentration monitoring switch is turned on, check the O2
sensor connection or replace the O2 battery, until the measured value can be displayed.

When it is found that the measurement deviation of the O2 sensor is large, it is necessary to recalibrate the O2
sensor: In the air, the measured value deviates from 21% by more than (3%); in pure oxygen, the measured
value deviates from 100% by more than (3%).
The specific operation steps of this calibration item are as follows:
1. Select the [Setup] key → [Calibration], enter the [Calibration] menu, and select the [O2] item.
2. Make sure to connect the high-pressure O2 source.
3. Press the [Start] key to start user O2 concentration calibration.

O2% calibration (manufacturer)

Attention
l When the error of the O2 concentration monitoring value is large, the O2 sensor is replaced, or
the monitoring main board is replaced, the O2 concentration calibration is required.

l Before calibration, under the measurement interface, observe whether FiO2 can display the
value. If not, confirm that the O2 concentration monitoring switch is turned on, check the O2
sensor connection or replace the O2 battery, until the measured value can be displayed.

6-17
Maintenance and Calibration

When it is found that the measurement deviation of the O2 sensor is large: In the air, the measured value
deviates from 21% by more than (3%); in pure oxygen, the measured value deviates from 100% by more than
(3%); or replace the O2 sensor; or replace the monitoring module board card, both of which requires O2
sensor recalibration.

Operation steps of O2 concentration calibration (manufacturer)

The specific operation steps of this calibration item are as follows:


1. Select the [Setup] key →[Maintain] → enter the manufacturer maintenance password, enter the [Service]
menu, select the [Calibration] item, and select the [O2 Cal.] item.
2. Make sure to connect the high-pressure O2 source.
3. Press the [Start] key to start manufacturer O2 concentration calibration. Calibration of the 21%
concentration point is carried out first, and then calibration of the 100% concentration point is carried
out.

Error codes and countermeasures of O2 concentration calibration

Error code Trigger cause Countermeasures


Connect or replace the O2
Failure prompt message
O2 supply is insufficient. source to ensure that the O2
number [1]
source pressure is normal.
1. The 21% sampling value of O2 battery
exceeds the lower limit, that is, the AD value is
less than 500
2. The 21% calibration sampling value of O2
battery exceeds the upper limit, that is, AD is
Failure prompt message greater than 1500
Replace the O2 sensor.
number [23] 3. The 100% sampling value of O2 battery
exceeds the lower limit, that is, the AD value is
less than 1500.
4. The 100% calibration sampling value of O2
battery exceeds the upper limit, that is, AD is
greater than 3700.

CO2 zero calibration (user)

Mainstream CO2 zero calibration

The purpose of zero calibration is to eliminate the influence of baseline drift on the results during the
measurement process, and to ensure the accuracy of the measurement results. The sensor needs to be
performed with zero calibration in the following situations:

6-18
Maintenance and Calibration

The sensor needs to be performed with zero calibration in the following situations:
1. When replacing the adapter.
2. When reconnecting the sensor to the module.
3. When the sensor is not in the best measurement state, the ventilator will prompt CO2 requires zero
calibration. At this time, please check the gas circuit adapter to ensure that the adapter window is not
blocked, such as mucus. If a blockage is found, the adapter needs to be cleaned or replaced.
The zero calibration steps are as follows:
1. Connect the sensor to the CO2 module.
2. Select the [Setup] key → [Sensor] → [CO2], and set the [Monitoring] to [On].
3. After preheating, install the sensor on a clean and dry gas circuit adapter. The adapter shall be connected
to the atmosphere and isolated from all CO2 sources, including the ventilator, patient respiration, and
your own respiration.
4. Select the [Setup] key → [Sensor] → [CO2], and select the [Start] key corresponding to CO2 zero
calibration on the right side of the screen. The screen prompts [CO2 Zero].
5. The typical zero calibration time is 5-20 seconds, and the prompt message disappears after the zero
calibration is completed.

Warning
l When the sensor is performed with zero calibration during the measurement, the sensor must
be disconnected from the patient’s gas circuit.

Sidestream CO2 zero calibration (user)

The purpose of zero calibration is to eliminate the influence of baseline drift on the results during the
measurement process, and to ensure the accuracy of the measurement results. The CO2 module will
automatically perform zero calibration when needed. The user can also perform manual zero calibration when
deemed necessary. During zero calibration, there is no need to disconnect the patient’s gas circuit.
The specific steps are as follows:
1. Select the [Setup] key → [Sensor] → [CO2], and press the [Zero] key to enable the zero calibration
function.
2. The typical zero calibration time is 5-20 seconds, and the prompt message disappears after the zero
calibration is completed.

Pressure and flow zero calibration (user)

When the pressure or flow rate waveform deviates from the baseline, zero calibration is required. During the
operation of the ventilator, the pressure and flow zero calibration will be performed automatically at regular
intervals, and manual zero calibration can be performed in the user maintenance menu. Manual zero
calibration can immediately eliminate the pressure and flow measurement deviation caused by the sensor zero
drift.

6-19
Maintenance and Calibration

The specific operation steps of this calibration item are as follows:


1. Select the [Setup] key → [Calibration], enter the [Calibration] menu, and select the [Zero] item;
2. Press the [Start] key to enable the user zero calibration function.

Pressure and flow zero calibration (manufacturer)

When the pressure or flow rate waveform deviates from the baseline, zero calibration is required. During the
operation of the ventilator, the pressure and flow zero calibration will be performed automatically at regular
intervals, and manual zero calibration can be performed in the manufacturer maintenance menu. Manual zero
calibration can immediately eliminate the pressure and flow measurement deviation caused by the sensor zero
drift.

Operation steps of pressure and flow zero calibration

1. Select the [Setup] key → [Maintain] → enter the manufacturer maintenance password, enter the [Service]
menu, select the [Calibration] item, and select the [Zero] item.

2. Disconnect the O2 source.


3. Disconnect the RESP tubing set from the patient.
4. Select [Start] to perform manual zero calibration operation.
5. If the zero calibration of pressure and flow rate is passed, the prompt message [Sensor Zeroing
Completed] will be displayed in the menu. If the zero calibration of pressure and flow rate fails, the
prompt message [Sensor Zeroing Failed. Carry out calibration again.] will be displayed in the menu.

Attention
l If the zero calibration fails, please troubleshoot and fix the fault first, and then perform the
flow calibration again.

6-20
Maintenance and Calibration

Pressure calibration (manufacturer)

Attention
l When replacing the main monitoring board, sensor adapter board, or expiratory valve
component, pressure calibration (manufacturer) is required.

l When it is found that there is a large deviation between the built-in pressure sensor of the
machine and the standard pressure measurement equipment (the deviation exceeds 2% of its
reading or 1 cmH2O), it is necessary to perform pressure calibration (manufacturer).

l Before calibration, it is recommended to disconnect the ventilator from the humidifier.

This calibration item is to use the ventilator calibration device to calibrate the inspiratory pressure sensor,
expiratory pressure sensor and expiratory valve of the ventilator. Supported calibration devices include: VT
Plus and PF300.

Operation steps of pressure calibration (manufacturer)

Attention
l Before pressure calibration, ensure the airtightness of tubing sets when connecting, and there
shall be no gas leakage.

l Do not move or squeeze the tubing set during calibration.

Use PF-300 for pressure calibration:


1. Enter the pressure calibration UI interface.
Select the [Setup] key → [Maintain] → enter the manufacturer maintenance password, enter the [Service]
menu, select the [Factor Cal.] item, and select the [Pressure Cal.] item. Select the calibration equipment as
[PF-300], as shown in the figure below:

6-21
Maintenance and Calibration

2. PF-300 zero calibration and settings.


a) After the PF-300 has been turned on and warmed up for 5 minutes, click the [MENU] key on the
front of the PF-300.

b) Then click the [Zero!] key to complete the zero calibration operation.

6-22
Maintenance and Calibration

c) After waiting for the zero calibration to be completed, press the key as shown in the figure below to
enter the P difference + measurement interface.

3. Calibration line connection


a) The calibration tooling is shown in the figure below. The line on the left is connected to the
multi-functional interface on the back of the ventilator; the communication line on the right is used
to connect to the RS-232 port of the PF-300. PF-300 calibration tooling, as shown in the figure
below:

b) Connect the calibration cable on the back of the ventilator, as shown in the figure below:

6-23
Maintenance and Calibration

c) PF-300 calibration cable connection, as shown in the figure below:

4. Calibration gas circuit connection, as shown in the figure below.


a) Connect the inspiration and expiration ports with the tubing set.

6-24
Maintenance and Calibration

b) Use the gas circuit connection tooling to connect the airway pressure sampling tube to PF-300.

5. Click the [Start] key on the interface of the ventilator to start calibration.

Error codes and countermeasures of pressure calibration

Error code Trigger cause Countermeasures


The pressures in the
calibration table of the turbine
pressure sensor, expiratory
Failure prompt message Check whether there is any leakage during
pressure sensor, and
number [3] calibration
inspiratory pressure sensor are
not monotonous: If the
expiratory valve is sealed with

6-25
Maintenance and Calibration

a larger current, the pressure


measured by the calibration
equipment is lower.
1. Check whether the expiratory valve
The set pressure has a large diaphragm is normal.
Failure prompt message
deviation from the actual 2. In the valve diagnostic test, test whether
number [6]
pressure. the safety valve can be normally closed and
opened.
Failure prompt message Communication error of Check the calibration equipment settings and
number [8] calibration equipment. communication cable connection
Failure prompt message
EEPROM read and write error. Recalibrate after restarting
number [10]
Failure prompt message The turbine pressure sensor
Recalibration
number [16] calibration curve is non-linear
The inspiratory pressure
Failure prompt message
sensor calibration curve is Recalibration
number [17]
non-linear
Failure prompt message The expiratory pressure sensor
Recalibration
number [18] calibration curve is non-linear

Expiratory valve calibration (manufacturer)

Attention
l When it is found that the expiratory valve control effect of the machine has a large deviation
from the set value (5cmH2O and 20% of the valve opening set value, whichever is greater), it is
necessary to perform expiratory valve calibration (manufacturer).

This calibration item uses the pressure sensor inside the ventilator that has been pressure-calibrated as the
calibration benchmark to calibrate the expiratory valve without using the ventilator calibration device.

Operation steps of expiratory valve calibration (manufacturer)

Attention
l Before expiratory valve calibration, ensure the airtightness of tubing sets when connecting, and
there shall be no gas leakage.

l Do not move or squeeze the tubing set during calibration.

1. Select the [Setup] key → [Maintain] → enter the manufacturer maintenance password, enter the [Service]
menu, select the [Calibration] item, and select the [Exp. Valve Cal.] item.
6-26
Maintenance and Calibration

2. Connect the RESP tubing set and insert the Y-shaped tee into the leak detection plug to seal the RESP gas
circuit.
3. Select the [Exp. Pressure Sensor] item for the calibration benchmark.
4. Press the [Start] key to start expiratory valve calibration.

Attention
l After the expiratory valve calibration, please detect the measurement accuracy of the pressure
sensor. For the detection steps, please refer to the description in Section 6.2.5 Pressure sensor
measurement accuracy detection.

l If the calibration fails, please troubleshoot and fix the fault first, and then perform the
expiratory valve calibration again.

Error codes and countermeasures of expiratory valve calibration

Error code Trigger cause Countermeasures


The pressure in the calibration
table of the expiratory pressure
sensor is not monotonous: If
Failure prompt message Check whether there is any leakage during
the expiratory valve is sealed
number [3] calibration
with a larger current, the
pressure measured by the
calibration equipment is lower.
The set pressure has a large 1. Check whether the expiratory valve
Failure prompt message
deviation from the actual diaphragm is normal.
number [6]
pressure. 2. In the valve diagnostic test, test whether

6-27
Maintenance and Calibration

the safety valve can be normally closed and


opened.
Failure prompt message
EEPROM read and write error. Recalibrate after restarting
number [10]

Air-oxygen calibration (manufacturer)

Attention
l After the O2 concentration calibration is completed, the measurement deviation of the O2
sensor is still large. In the air, the measured value deviates from 21% by more than 3%; in
pure oxygen, the measured value deviates from 100% by more than 3%, air-oxygen calibration
is required.

l Air-oxygen calibration is required after replacing the inspiratory flow sensor or O2 flow
sensor.

This calibration item uses the measured values of the O2 flow sensor and the inspiratory flow sensor inside
the ventilator to calculate the air-oxygen coefficient, and no external calibration equipment is required.

Operation steps of air-oxygen calibration (manufacturer)

Attention
l Before air-oxygen calibration, make sure that the air inlet of the main unit is blocked and there
is no gas leakage.

l In the calibration process, make sure that the ventilator is connected to a high-pressure O2
source and the gas source is sufficient, otherwise the calibration may fail.

1. Select the [Setup] key → [Maintain] → enter the manufacturer maintenance password, enter the [Service]
menu, select the [Calibration] item, and select the [Air-O2 Cal.] item.
2. Connect the high-pressure O2 source and confirm that the gas source is sufficient.

6-28
Maintenance and Calibration

3. Remove the air inlet baffle and high-efficiency filter of the main unit.

4. Insert the special fixture into the air inlet to ensure that the air circuit of the main unit is closed.

5. Press the [Start] key to start the air-oxygen calibration.

Attention

6-29
Maintenance and Calibration

l After the air-oxygen calibration is successful, please detect the accuracy of the O2
concentration measurement to ensure that the deviation between the O2 concentration value
measured by the O2 sensor and the O2 concentration set value does not exceed 3%.

l If the calibration fails, please troubleshoot and fix the fault first, and then perform the
air-oxygen calibration again.

Error codes and countermeasures of air-oxygen calibration

Error code Trigger cause Countermeasures


Failure prompt message Connect or replace the O2 source to ensure
O2 supply is insufficient.
number [1] that the O2 source pressure is normal.
Failure prompt message Calibration table writes
Recalibrate after restarting.
number [10] EEPROM timeout.

6-30
Chapter 7 Troubleshooting

Overview

This chapter divides the ventilator faults into gas circuit system faults, hardware and electrical system faults,
software faults and upgrades. The gas circuit system faults are classified according to the location where they
occur. When troubleshooting, please refer to the corresponding fault table, and follow the detection process
mentioned in this chapter to locate and eliminate the fault.
After locating the faulty component, please refer to Chapter 7 Maintenance and Disassembly to disassemble
the equipment, and maintain and replace the faulty component.

System Self-test Failure Troubleshooting

During system self-test, if there is a failure item, please follow the following measures to troubleshoot.
Failed system
Possible cause Measure
self-test
Turbine test 1. The turbine power supply 1. Confirm that the turbine power supply wires are
cable is disconnected. connected correctly.
2. Turbine failure. 2. Replace the turbine.
O2 flow sensor 1. Insufficient high-pressure 1. Check whether the high-pressure O2 source is connected
test O2 supply. and whether the gas source is sufficient.
2. Low-pressure O2 2. In [Setup] → [Maintain] → input user maintenance
ventilation. password → [Setting] → [Gas Supply], check to see if
3. The O2 proportional valve low-pressure O2 is selected. If yes, please switch to
has a large deviation from high-pressure O2.
the O2 flow sensor. 3. Perform the flow calibration again. See Section 6.3.2
4. O2 proportional valve Flow calibration (manufacturer).
failure. 4. Diagnose whether the O2 proportional valve is abnormal
5. O2 flow sensor failure. on the valve diagnosis interface (see 6.6.3.3 Diagnosis of
abnormal state of the inspiratory valve or O2 proportional
valve). If it is abnormal, replace the O2 proportional valve
and perform the system self-test again.
5. Check whether the O2 flow sensor is properly connected.
If the fault still exists, replace the O2 flow sensor and
perform the system self-test again.
6. Replace the monitoring board.

7-1
Troubleshooting

Inspiratory 1. The valve opening flow 1. Perform the flow calibration again. See Section 5.3.2
flow sensor rate deviation between the Flow calibration (manufacturer).
test inspiratory flow sensor and 2. Diagnose whether the inspiratory valve is abnormal on
the inspiratory valve is large. the valve diagnosis interface (see 6.6.3.3 Diagnosis of
2. The inspiratory valve is abnormal state of the inspiratory valve or O2 proportional
malfunctioning. valve). If it is abnormal, replace the inspiratory valve and
3. The inspiratory flow perform the system self-test again.
sensor is malfunctioning. 3. Check whether the inspiratory flow sensor is properly
connected. If the fault still exists, replace the inspiratory
flow sensor and perform the system self-test again.
4. Replace the monitoring board.
Expiratory 1. The Y-shaped tee is not 1. Check whether the Y-shaped tee is blocked or the tubing
flow sensor blocked or the tubing set is set is connected.
test not connected. 2. Perform the flow calibration again. See Section 5.3.2
2. The expiratory flow sensor Flow calibration (manufacturer).
and the inspiratory flow 3. Check whether the expiratory flow sensor is properly
sensor have a large deviation connected. If the fault still exists, replace the expiratory
in the measured flow rate. flow sensor and perform the flow calibration and system
3. The expiratory flow sensor self-test again.
is malfunctioning. 4. Replace the monitoring board.
Pressure sensor 1. The Y-shaped tee is not 1. Check whether the Y-shaped tee is blocked or the tubing
test blocked or the tubing set is set is connected.
not connected. 2. Perform pressure calibration again.
2. The pressure measured by 3. Confirm whether the sampling tubes of the inspiratory
the inspiratory pressure pressure and expiratory pressure sensors are intact (no
sensor and the expiratory rupture) and connected correctly.
pressure sensor have a large 4. Confirm that the power supply wire of the expiratory
deviation from the valve valve is connected correctly and the expiratory valve is
opening pressure of the installed correctly, and perform the system self-test again.
expiratory valve. 5. Diagnose whether the expiratory valve is abnormal on the
3. The sampling tubes of the valve diagnosis interface (see 6.6.3.4 Diagnosis of abnormal
inspiratory pressure and state of the expiratory valve). If it is abnormal, replace the
expiratory pressure sensors expiratory valve and perform the system self-test again.
are not connected or have 6. Replace the monitoring board.
gas leakage.
4. The expiratory valve is not
installed or the expiratory
power supply is abnormal.
5. The expiratory valve is

7-2
Troubleshooting

abnormal.
Expiratory Same as “pressure sensor Same as “pressure sensor test”.
valve test test”.
Safety valve 1. The Y-shaped tee is not 1. Check whether the Y-shaped tee is blocked or the tubing
test blocked or the tubing set is set is connected.
not connected. 2. Confirm that the power supply wire of the safety valve is
2. The power supply of the connected correctly.
safety valve is abnormal. 3. Diagnose whether the safety valve is abnormal on the
3. The safety valve is valve diagnosis interface (see 6.6.3.5 Diagnosis of abnormal
abnormal. state of the safety valve). If it is abnormal, replace the safety
valve and perform the system self-test again.
4. Replace the monitoring board.
Leakage 1. The Y-shaped tee is not 1. Check whether the Y-shaped tee is blocked or the tubing
(ml/min) blocked or the tubing set is set is connected.
not connected.
Compliance Same as “leak test”. Same as “leak test”.
(mL/cmH2O)
Pipeline 1. The Y-shaped tee is not 1. Check whether the Y-shaped tee is blocked or the tubing
resistance blocked or the tubing set is set is connected.
(cmH2O/L/s) not connected.
O2 sensor test 1. The O2 monitoring 1. The O2 monitoring function is enabled.
function of the interface is 2. Make sure that the O2 sensor is connected correctly and
disabled. that there is no alarm related to the O2 sensor on the
2. The O2 sensor is not interface, and then perform the O2 sensor test again.
connected or the O2 sensor 3. Check whether the high-pressure O2 source is connected
fails. and whether the gas source is sufficient.
3. Insufficient high-pressure 4. Perform O2 sensor calibration.
O2 supply. 5. Replace the monitoring board.

Technical Alarms and Diagnosis

Please pay attention to whether the ventilator displays technical alarm information. If any, please follow the
following prompts to troubleshoot first to avoid unnecessary equipment disassembly.
The following is a detailed description of the troubleshooting of the technical alarms of the ventilator. For the
causes and countermeasures of technical alarm information of other modules, please refer to the User Manual
of this ventilator.
The level column indicates the default alarm levels: H stands for high-level, M stands for medium-level, L
stands for low-level; and P stands for prompt message.

7-3
Troubleshooting

Technical alarms of the main control board

Serial
Alarm Level Possible cause Countermeasures
No.
1. Replace the button cell, and reset the date
Please Reset There is no button cell in the
and time;
1. Date and L system, or there is no power in
2. If the fault still exists, replace the main
Time the battery.
control board.
Technical L, M A technical error alarm has
2. Refer to 7.4 List of Fault Codes.
Error ** or H occurred.
Device L, M A machine failure alarm has
3. Refer to 7.4 List of Fault Codes.
Failure ** or H occurred.

Key board technical alarm

Serial
Alarm Level Possible cause Countermeasures
No.
1. The key is timed out, and correct the
The mute key is
operation;
1. Key Error L malfunctioning or has poor
2. Replace the key board;
contact.
3. Replace the main control board.
1. The key is timed out, and correct the
Rotary The rotary encoder is
operation;
2. Encoder L malfunctioning or has poor
2. Replace the key board;
Error contact.
3. Replace the main control board.
Technical L, M A technical error alarm has
3. Refer to 7.4 List of Fault Codes.
Error ** or H occurred.

Technical alarms of the monitoring board

Serial
Alarm Level Possible cause Countermeasures
No.

7-4
Troubleshooting

End-tidal positive
pressure is too high.
1. Refer to Section 6.2.5 Pressure sensor
The end-tidal
measurement accuracy detection, and check the
positive pressure
1. PEEP Too High H pressure sensor; if it is inaccurate, please
monitoring value is
recalibrate;
higher than the
2. Check the parameter settings.
PEEP set value of
+5 cmH2O.
End-tidal positive
pressure is too low.
1. Refer to Section 6.2.5 Pressure sensor
The end-tidal
measurement accuracy detection, and check the
positive pressure
pressure sensor; if it is inaccurate, please
monitoring value is
2. PEEP Too Low M recalibrate;
lower than a certain
2. Check whether the expiratory valve is installed
value of the PEEP
correctly;
set value, and this
3. Check the parameter settings.
value is defaulted by
the software.
1. Check whether there is any blockage in the
patient-end tubing set; if so, please unblock it;
2. Refer to Section 6.2.4 Flow sensor measurement
The patient-end accuracy detection, and check the flow sensor; if it
Airway
3. H tubing set is is inaccurate, please recalibrate;
Obstructed?
blocked. 3. Refer to Section 6.2.5 Pressure sensor
measurement accuracy detection, and check the
pressure sensor; if it is inaccurate, please
recalibrate.
1. Check the parameter settings;
Sustained The patient’s airway 2. Refer to Section 6.2.5 Pressure sensor
4. Airway H pressure continues measurement accuracy detection, and check the
Pressure to be at a high level. pressure sensor; if it is inaccurate, please
recalibrate.

7-5
Troubleshooting

1. Check whether there is any leakage in the


patient-end tubing set; if it leaks, please replace the
tubing set;
2. Refer to Section 6.2.4 Flow sensor measurement
The patient-end
accuracy detection, and check the flow sensor; if it
5. Airway Leak? L tubing set has
is inaccurate, please recalibrate;
leakage.
3. Refer to Section 6.2.5 Pressure sensor
measurement accuracy detection, and check the
pressure sensor; if it is inaccurate, please
recalibrate.
1. Check whether the tubing set is detached or
loose; if so, please reconnect it;
2. Refer to Section 6.2.4 Flow sensor measurement
accuracy detection, and check the flow sensor; if it
Tube The tubing set is
6. H is inaccurate, please recalibrate;
Disconnected? detached
3. Refer to Section 6.2.5 Pressure sensor
measurement accuracy detection, and check the
pressure sensor; if it is inaccurate, please
recalibrate.
1. Check the parameter settings, including the
upper limit setting of the pressure alarm;
The pressure reaches 2. Check whether there is a pressure sensor failure
Pressure the upper limit of alarm (corresponding alarm strings are “machine
7. L
Limited the pressure alarm failure 09” and “machine failure 21”); if there is a
of -5cmH2O. failure, please replace it;
3. If the failure still exists, please replace the
monitoring board.
1. Check the parameter settings, including the
In pressure mode, if
upper limit setting of the expiratory tidal volume
the inspiration
alarm;
exceeds the upper
Volume 2. Check whether there is an alarm of “please
8. L limit of the set tidal
Limited check the expiratory flow sensor”; if there is such
volume, it will
an alarm, please eliminate the alarm first;
switch to expiration
3. If the failure still exists, please replace the
in advance.
monitoring board.

7-6
Troubleshooting

1. Check whether the pipeline has leakage; if so,


please reconnect it;
The peak airway 2. Refer to Section 6.2.5 Pressure sensor
Pinsp Not
9. L pressure fails to measurement accuracy detection, and check the
Achieved
reach the set value. pressure sensor; if it is inaccurate, please
recalibrate;
3. Check the parameter settings.
1. Check whether the pipeline has leakage; if so,
please reconnect it;
2. Refer to Section 6.2.4 Flow sensor measurement
TV Not Tidal volume fails to
10. L accuracy detection, and check the flow sensor; if it
Achieved reach the set value.
is inaccurate, please recalibrate;
3. Check whether the parameter settings are
reasonable.
1. Check the parameter settings, including the
After the sigh
upper limit setting of the pressure alarm;
function is activated,
2. Check whether there is a pressure sensor failure
Pressure the pressure of the
alarm (corresponding alarm strings are “machine
11. Limited in Sigh L sigh cycle reaches
failure 09” and “machine failure 21”); if there is a
Cycle the upper limit of
failure, please replace it;
the pressure alarm
3. If the failure still exists, please replace the
of -5cmH2O.
monitoring board.
1. Check whether the high-pressure O2 source is
connected and whether the gas source is sufficient;
2. Diagnose whether the O2 proportional valve is
O2 Supply O2 supply is abnormal on the valve diagnosis interface (see
12. H
Failure insufficient. 7.6.3.3 Diagnosis of abnormal state of the
inspiratory valve or O2 proportional valve); if it is
abnormal, replace the O2 proportional valve;
3. Replace the monitoring board.
The autonomous
respiration in PSV
mode has not met
1. Check the parameter settings;
the expiratory
13. Tinsp Too Long L 2. Check and replace the pressure and flow
sensitivity and thus
sensors.
the inspiration
process cannot be
ended.

7-7
Troubleshooting

Watchdog The external


14. H Replace the monitoring board.
Failure watchdog is invalid.
1. Check whether the operating environment
temperature of the machine exceeds the maximum
operating temperature of 40 ℃ claimed by the
manufacturer;
2. Check whether the fan inlet and air outlet are
blocked; if they are blocked, clean foreign objects
Insp. Gas The inhaled gas and dust, and check the operation of the fan; if it is
15. Temp. Too H temperature exceeds abnormal (such as abnormal noise, abnormal
High the limit. speed, etc.), replace the fan;
3. In the A/D channel, check whether the
temperature measured values of the inhaled gas
mixture and O2 are outside the range provided by
the A/D channel, and replace the flow sensor (gas
mixture flow sensor or O2 flow sensor) that
corresponds to the temperature exceeding the limit.
The high-efficiency
Replace the
16. L particulate air filter Replace the high-efficiency particulate air filter.
HEPA Filter
is blocked.
1. Check whether the O2 sensor cable is off; if so,
O2 Sensor The O2 sensor is not
17. L please reconnect it.
Unconnected connected.
2. If the failure still exists, replace the O2 sensor.
Replace O2 The O2 sensor is
18. M Replace the O2 sensor.
Sensor exhausted.
The O2 sensor is not
calibrated (neither
Calibrate O2 Recalibrate the 21% and 100% O2 sensors, see
19. L the manufacturer nor
Sensor Section 6.3.4 O2% calibration (manufacturer).
the user is
calibrated)
Calibrate O2 The O2 valve is not
20. H Recalibrate the O2 valve
Valve calibrated
The inspiratory
Calibrate Insp.
21. H valve is not Recalibrate the inspiratory valve
Valve
calibrated
Calibrate Exp. The expiratory valve
22. H Recalibrate the expiratory valve
Valve is not calibrated

7-8
Troubleshooting

Air Flow
Air flow sensor type Check whether the gas mixture flow sensor is an
23. Sensor Type H
error. air flow sensor; if not, replace it.
Error
O2 Flow
O2 flow sensor type Check whether the O2 branch flow sensor is an O2
24. Sensor Type H
error. flow sensor; if not, replace it.
Error
Calibrate Flow Please calibrate the
25. H Please perform flow calibration
Sensor flow sensor

Calibrate Please calibrate the Please contact the designated maintenance service
26. H
Pressure Sensor pressure sensor. provider

1. Check whether the operating environment


temperature of the machine exceeds the maximum
operating temperature of 40 ℃ claimed by the
The turbine manufacturer.
Blower Temp.
27. H temperature exceeds 2. Check whether the fan inlet and air outlet are
Too High
a certain threshold. blocked; if they are blocked, clean foreign objects
and dust, and check the operation of the fan; if it is
abnormal (such as abnormal noise, abnormal
speed, etc.), replace the fan.
1. Check whether the operating environment
temperature of the machine exceeds the maximum
operating temperature of 40 ℃ claimed by the
The equipment manufacturer.
Device Temp.
28. H temperature exceeds 2. Check whether the fan inlet and air outlet are
Too High
a certain threshold. blocked; if they are blocked, clean foreign objects
and dust, and check the operation of the fan; if it is
abnormal (such as abnormal noise, abnormal
speed, etc.), replace the fan.
Technical Error L、M A technical error
29. Refer to 7.4 List of Fault Codes.
** or H alarm has occurred.
Device Failure L、M A machine failure
30. Refer to 7.4 List of Fault Codes.
** or H alarm has occurred.
A communication
L、M
31. Comm Error ** failure alarm has Refer to 7.4 List of Fault Codes.
or H
occurred.
Blower Failure H or A turbine failure
32. Refer to 7.4 List of Fault Codes.
** M alarm has occurred.

7-9
Troubleshooting

An inspiratory
Insp. Limb
33. H branch failure has Refer to 7.4 List of Fault Codes.
Failure **
occurred.
An expiratory
Exp. Limb H or
34. branch failure has Refer to 7.4 List of Fault Codes.
Failure ** M
occurred.
O2 Limb An O2 branch
35. H Refer to 7.4 List of Fault Codes.
Failure ** failure has occurred.

Auxiliary monitoring board technical alarm

Serial
Alarm Level Possible cause Countermeasures
No.
A communication
1. Comm Error ** H failure alarm has Refer to 7.4 List of Fault Codes.
occurred.
The internal voltage
Device Failure
2. H of the machine is Refer to 7.4 List of Fault Codes.
**
abnormal

Power panel technical alarm

Serial
Alarm Level Possible cause Countermeasures
No.
Battery1 Battery 1 has a
1. H Replace the battery 1.
Failure ** failure alarm.
Battery 2 Battery 2 has a
2. H Replace the battery 2.
Failure ** failure alarm.
The temperature of
Battery Temp. 1. Confirm whether the operating ambient
the battery is too
3. High. Connect M temperature is too high, such as over 40℃; if it
high during
Ext. Pwr exceeds, it is recommended that the customer use it
discharging.

7-10
Troubleshooting

in a lower ambient temperature and ensure that


there is no heat source near the machine;
2. Check whether the fan inlet and air outlet are
blocked; if they are blocked, clean foreign objects
The temperature of
Battery Temp. and dust, and check the operation of the fan; if it is
the battery is too
4. High. Sys H abnormal (such as abnormal noise, abnormal
high during
Maybe Down speed, etc.), replace the fan;
discharging.
3. If the above 2 items are excluded, check whether
the battery is normal;
4. If the failure still exists, please replace the
DC-DC board.
1. Check the external power connection;
2. If the external power supply is connected
normally and the voltage is normal, check the
5. Battery in Use L Battery is employed. connection between the external power supply and
the power panel, socket and fuse;
3. If the failure still exists, please replace the
DC-DC board.
The remaining 1. The system is operational, please connect to an
Low Battery.
battery power is external power supply immediately;
6. Connect Ext. M
below a certain 2. Check whether the battery can be charged
Power
threshold. normally; if it cannot be charged, please replace the
DC-DC board;
3. Perform a battery maintenance: Fully charge,
System
discharge, and then fully charge, confirm whether
DOWN. The battery is about
7. H the battery charging/power supply time is normal;
Connect Ext. to run out.
if the charging or power supply time is
Power
significantly shortened, consider replacing the
battery.
The battery is not 1. Check whether the battery is normal; if there is a
installed or the problem with the battery, replace the battery;
interface cable 2. If the battery is normal, check whether the wire
Battery
8. H between the battery connection between the battery adapter board and
Undetected
and the power the DC-DC board is normal.
module is not 3. If the failure still exists, please replace the
connected. DC-DC board.
1. Replace the fan;
9. Fan Failure M Fan hardware failure 2. If the failure still exists, please replace the
DC-DC board.

7-11
Troubleshooting

Module technical alarm

Source Alarm Level Causes and countermeasures


CO2 Comm
H The module has failed. Return to the manufacturer for maintenance.
Err
CO2 Line Check and replace the sampling tube. If the fault persists, contact the
L
Blocked manufacturer for maintenance.
The sampling tube is not connected or has poor contact. Check and replace
CO2 No
General L the sampling tube. If the fault persists, contact the manufacturer for
Sampling Line
alarm for maintenance.
CO2 CO2 Out Of
The measured value is beyond the claimed accuracy range. Please follow the
modules Accuracy L
manufacturer's stated accuracy range for measurement.
Range
CO2 Temp
L The module has failed. Return to the manufacturer for maintenance.
Out Of Range
CO2 Need CO2 needs to be zeroed. Enter the CO2 settings to return to zero. Returning
L
Zero zero here is equal to zero calibration.
CO2 Span
L CO2 range is calibrating
Calibrating...
CO2 Span Cal The module has failed. It needs to be returned to the manufacturer for
L
Error maintenance.
Replace CO2 The adapter is abnormal. Check and replace the adapter. If the fault persists,
L
Adapter contact the manufacturer for maintenance.
CO2 No The adapter is not connected or has poor contact. Check and replace the
L
Adapter adapter. If the fault persists, contact the manufacturer for maintenance.
CO2 Software
Masimo L A software error has occurred. Please reboot.
Error
CO2
CO2
module A hardware error has occurred. Check and replace the sensor. If the fault
Hardware L
persists, contact the manufacturer for maintenance.
Error
CO2 Speed
Out Of L The module has failed. Return to the manufacturer for maintenance.
Bounds
CO2 Factory
Calibration L The module has failed. Return to the manufacturer for maintenance.
Lost
CO2 Pressure L The module has failed. Return to the manufacturer for maintenance.

7-12
Troubleshooting

Overrange
CO2 ID
Respironic L CO2 ID does not match. Re-plug the CO2 module.
unmatched
s CO2
CO2 Need
module L CO2 needs to be calibrated. Please perform CO2 calibration.
Calibrate
CO2 ID
Comen L CO2 ID does not match. Re-plug the CO2 module.
unmatched
CO2
CO2 Need
module L CO2 needs to be calibrated. Please perform CO2 calibration.
Calibrate
SpO2 Finger The SpO2 sensor has been detached from the finger. Check the connection of
M
Off the SpO2 sensor.
SpO2 No The SpO2 sensor is not connected properly. Check the connection of the
L
Sensor SpO2 sensor.
SpO2 Low The SpO2 sensor is not connected properly. Check the connection of the
L
Signal SpO2 sensor.
The SpO2 sensor is not connected properly or the patient’s arm is moving.
General
Search Pulse L Check the connection of the SpO2 sensor and the current condition of the
alarm for
patient.
SpO2
The SpO2 sensor is not connected properly or the patient’s arm is moving.
modules
No Pulse H Check the connection of the SpO2 sensor and the current condition of the
patient.
SpO2 Comm The SpO2 module cannot communicate with the main system. Reboot and try
H
Stop again. If the error persists, contact the manufacturer for maintenance.
The SpO2 module cannot communicate normally with the main system.
SpO2 Comm
H Reboot and try again. If the error persists, contact the manufacturer for
Err
maintenance.
The peripheral circulation is not smooth. Replace other fingers, or detect the
SpO2 Low
L presence or absence of limb compression resulting in poor peripheral
Perfusion
circulation.
SpO2 Sensor Sensor failure. Check and replace the sensor. If the fault persists, contact the
L
Masimo Fault manufacturer for maintenance.
SPO2 External interference is too strong. Check the connection of the SpO2 lead
SpO2
module L wire, check the current condition of the patient, and whether there is a big
Interference
action.
The patient (sensor) receives too much light. Improper fabric covers the
SpO2 Too
L sensor detector. Check that the SpO2 probe is clamped, remove or reduce the
Much Light
light, cover the sensor from light, and reposition the sensor.

7-13
Troubleshooting

SpO2
The SpO2 module cannot recognize the probe. Check and replace the probe.
Unknown L
If the fault persists, contact the manufacturer for maintenance.
Sensor
SpO2 No The cable is not connected or not connected well. Check and replace the
L
Cable cable. If the fault persists, contact the manufacturer for maintenance.
SpO2 No
The adhesive probe is disconnected. Please check the adhesive probe and
Adhesive L
replace with a suitable adhesive probe.
Sensor
SpO2 Module
L Module failure. Return to the manufacturer for maintenance.
Error
Nellcor NELLCOR module error, system reset. If the fault still exists after the system
Nellcor Error,
SpO2 L fails to reset or restart the monitor, please contact the manufacturer for
Resetting
module maintenance.
SpO2 Sensor Sensor failure. Check and replace the sensor. If the fault persists, contact the
L
Fault manufacturer for maintenance.
Comen
SpO2 Low The SpO2 sensor is not connected properly. Check the connection of the
SpO2 L
Signal SpO2 sensor.
module
SpO2 Module
L Module failure. Return to the manufacturer for maintenance.
Error

List of Fault Codes

Serial Alarm
Fault code Possible cause Countermeasures
No.
The temperature
Battery1 of battery 1 is
Failure 01 higher than
expected.
Battery1 Battery 1
Battery Failure 02 charging failure.
1. 1 Battery1 Replace the battery 1
Battery 1 aging.
Failure Failure 03
Battery 1
Battery1
communication
Failure 04
abnormality.
Battery1
Battery 1 failure.
Failure 05
2. Battery Battery 2 The temperature Replace the battery 2

7-14
Troubleshooting

2 Failure 01 of battery 2 is
Failure higher than
expected.
Battery 2 Battery 2
Failure 02 charging failure.
Battery 2
Battery 2 aging.
Failure 03
Battery 2
Battery 2
communication
Failure 04
abnormality.
Battery 2
Battery 2 failure.
Failure 05
1. Check whether there is a “technical error 02” alarm
at the same time. If it exists, check the “pressure value
measured by the Pfilter pressure sensor” or the
HEPA filter
Technical “atmospheric pressure measured by the atmospheric
pressure sensor
Error 01 pressure sensor” in the A/D channel, which value is
failure.
closer to the current ambient atmospheric pressure, and
replace the sensor with a larger deviation.
2. Replace the monitoring board.
1. Check whether there is a “technical error 01” alarm
at the same time. If it exists, check the “pressure value
Ambient measured by the Pfilter pressure sensor” or the
Technical atmospheric “atmospheric pressure measured by the atmospheric
Techni
Error 02 pressure sensor pressure sensor” in the A/D channel, which value is
3. cal
failure. closer to the current ambient atmospheric pressure, and
Error
replace the sensor with a larger deviation.
2. Replace the monitoring board.
1. In the A/D channel, check whether the temperature
measured values of the inhaled gas mixture and
Inspiratory
Technical inhaled O2 are too large or too small, and replace the
temperature
Error 03 temperature sensor with the problem;
sensor failure.
2. Replace the inhaled gas mixture temperature sensor
and inhaled O2 temperature sensor.
Technical Atomization
Replace the atomization valve.
Error 05 valve failure.
Technical Inspiratory
Replace the inspiratory pressure three-way valve.
Error 06 pressure

7-15
Troubleshooting

three-way valve
failure.
Turbine pressure
Technical
three-way valve Replace the turbine pressure three-way valve.
Error 07
failure.
Expiratory
Technical pressure
Replace the expiratory pressure three-way valve.
Error 08 three-way valve
failure.
Inspiratory flow
Technical
three-way valve Replace the inspiratory flow three-way valve.
Error 09
failure.

Technical
Buzzer failure. Replace the monitoring board.
Error 21

Abnormal power
1. Measure the voltage at the corresponding test point;
Device supply of
2. If the failure still exists, replace the monitoring
Failure 20 protection
board.
module
Device Safety valve
Replace the safety valve.
Failure 21 failure.
The reference 1. Measure the voltage at the corresponding test point;
Device
voltage is 2. If the failure still exists, replace the monitoring
Failure 50
abnormal. board.
The analog 1. Measure the voltage at the corresponding test point;
Device
voltage is 2. If the failure still exists, replace the monitoring
Failure 51
Device abnormal. board.
4.
Failure The analog 1. Measure the voltage at the corresponding test point;
Device
voltage is 2. If the failure still exists, replace the monitoring
Failure 52
abnormal. board.

The main control 1. Measure the voltage at the corresponding test point;
Device
board voltage is 2. If the failure still exists, replace the monitoring
Failure 53
abnormal. board.
The backup 1. Measure the voltage at the corresponding test point;
Device
voltage is 2. If the failure still exists, replace the monitoring
Failure 54
abnormal. board.
The expiratory 1. Measure the voltage at the corresponding test point;
Device
valve voltage is 2. If the failure still exists, replace the monitoring
Failure 55
abnormal. board.

7-16
Troubleshooting

The main control 1. Measure the voltage at the corresponding test point;
Device
board voltage is 2. If the failure still exists, replace the monitoring
Failure 56
abnormal. board.

The main control 1. Measure the voltage at the corresponding test point;
Device
board voltage is 2. If the failure still exists, replace the monitoring
Failure 57
abnormal. board.

The monitoring 1. Measure the voltage at the corresponding test point;


Device
board voltage is 2. If the failure still exists, replace the monitoring
Failure 58
abnormal. board.
The safety valve 1. Measure the voltage at the corresponding test point;
Device
voltage is 2. If the failure still exists, replace the monitoring
Failure 59
abnormal. board.
The system 1. Measure the voltage at the corresponding test point;
Device
voltage is 2. If the failure still exists, replace the monitoring
Failure 60
abnormal. board.
The turbine 1. Measure the voltage at the corresponding test point;
Device
voltage is 2. If the failure still exists, replace the monitoring
Failure 61
abnormal. board.
The voice coil 1. Measure the voltage at the corresponding test point;
Device
motor voltage is 2. If the failure still exists, replace the monitoring
Failure 62
abnormal. board.
The system 1. Measure the voltage at the corresponding test point;
Device
voltage is 2. If the failure still exists, replace the monitoring
Failure 63
abnormal. board.

The
high-pressure O2 1. Measure the voltage at the corresponding test point;
Device
proportional 2. If the failure still exists, replace the monitoring
Failure 64
valve voltage is board.
abnormal.

The heater sensor 1. Measure the voltage at the corresponding test point;
Device
voltage is 2. If the failure still exists, replace the monitoring
Failure 65
abnormal. board.
The power panel 1. Measure the voltage at the corresponding test point;
Device
charging voltage 2. If the failure still exists, replace the monitoring
Failure 70
is abnormal. board.
The switching 1. Measure the voltage at the corresponding test point;
Device
power supply 2. If the failure still exists, replace the monitoring
Failure 71
voltage is board.

7-17
Troubleshooting

abnormal.
The external DC
1. Measure the voltage at the corresponding test point;
Device power supply
2. If the failure still exists, replace the monitoring
Failure 72 voltage is
board.
abnormal.
The total power
1. Measure the voltage at the corresponding test point;
Device supply voltage of
2. If the failure still exists, replace the monitoring
Failure 73 the system is
board.
abnormal.
The power 1. Measure the voltage at the corresponding test point;
Device
supply voltage is 2. If the failure still exists, replace the monitoring
Failure 74
abnormal. board.
1. Check whether the board card interface is in poor
The
contact; if so, please re-plug or replace the
communication
communication line;
between the
Device 2. Check whether the board card is damaged; if it is
power panel and
Failure 75 damaged, please replace the corresponding board card;
the main control
3. Check whether the software version is compatible; if
board is
it is not compatible, please re-upgrade the correct
abnormal.
software version.
1. Check whether the operating environment
temperature of the machine exceeds the operating
temperature;
The turbine
Blower 2. Check whether the fan inlet and air outlet are
temperature is
Failure 01 blocked; if they are blocked, clean foreign objects and
too high.
dust, and check the operation of the fan; if it is
abnormal (such as abnormal noise, abnormal speed,
etc.), replace the fan.
Blower Check the internal temperature of the turbine and the
5. Turbine
Failure Blower external temperature of the turbine in the A/D channel;
temperature
Failure 02 if the internal temperature (or external temperature)
sensor failure.
exceeds the limit, replace the temperature sensor.
1. Check whether there is a “technical error 02” alarm
at the same time. If it exists, check the “pressure value
Blower Turbine pressure measured by the Pfilter pressure sensor” or the
Failure 03 sensor failure “atmospheric pressure measured by the atmospheric
pressure sensor” in the A/D channel, which value is
closer to the current ambient atmospheric pressure, and

7-18
Troubleshooting

replace the sensor with a larger deviation.


2. Replace the monitoring board.
Blower Turbine Check the hardware of the monitoring board and
Failure 04 hardware failure replace it if it is faulty.
Blower The turbine
Replace the turbine.
Failure 05 failed.
Insp. Limb Inspiratory flow 1. Check the inspiratory flow sensor;
Failure 06 sensor failure. 2. Replace and calibrate the inspiratory flow sensor.

Inspiratory 1. Check the inspiratory pressure sensor;


Insp. Insp. Limb
pressure sensor 2. Replace and calibrate the inspiratory pressure
6. Limb Failure 07
failure sensor.
Failure
The inspiratory
Insp. Limb 1. Check the connection of the inspiratory valve;
valve is
Failure 08 2. Replace the inspiratory valve.
detached.
Exp. Limb Expiratory flow 1. Check the expiratory flow sensor;
Failure 10 sensor failure. 2. Replace and calibrate the expiratory flow sensor.

Exp. Expiratory
Exp. Limb 1. Check the expiratory pressure sensor;
7. Limb pressure sensor
Failure 11 2. Replace and calibrate the expiratory pressure sensor.
Failure failure

Exp. Limb Expiratory valve 1. Check the connection the expiratory valve;
Failure 12 failure 2. Replace the expiratory valve.

O2 Limb O2 flow sensor 1. Check the O2 flow sensor;

Failure 15 failure. 2. Replace and calibrate the O2 flow sensor.


O2
1. Check whether the O2 proportional valve is working
8. Limb
O2 Limb O2 proportional properly; if it is not working properly, please replace
Failure
Failure 16 valve failure the O2 proportional valve;

2. Replace and calibrate the O2 proportional valve.

Communication
between the 1. Check whether the board card interface is in poor

Comm monitoring board contact; if so, please re-plug or replace the

Error 23 and the main communication line;

Comm control board is 2. Check whether the board card is damaged; if it is


9.
Error abnormal damaged, please replace the corresponding board card;

Communication 3. Check whether the software version is compatible; if


Comm between the it is not compatible, please re-upgrade the correct
Error 24 monitoring board software version.
and the VPM is

7-19
Troubleshooting

abnormal

Communication
between the main
Comm
control board and
Error 30
the key board is
abnormal
Communication
between the main
Comm control board and
Error 31 the monitoring
board is
abnormal
Communication
between the main
Comm
control board and
Error 32
the power panel
is abnormal
Communication
between the
Comm VPM and the
Error 66 main control
board is
abnormal
Communication
between the
Comm
VPM and the
Error 67
monitoring board
is abnormal
Communication
between the key
Comm
board and the
Error 75
monitoring board
is abnormal
Communication
between the key
Comm
board and the
Error 80
main control
board is

7-20
Troubleshooting

abnormal

Diagnostic Test

Operation before use of valve diagnostic tool

If you use a valve diagnostic tool to locate and diagnose valve or sensor failures, you must first perform the
following preparatory operations:
1. Connect the gas circuit according to the type of sensor or valve to be checked:
n Constant current connection method: If you need to check each flow sensor and inspiratory valve,
please follow the “constant flow connection method” to connect the ventilator tubing set. For the
specific method, please connect according to the method described in the Section 6.2.4 Flow sensor
measurement accuracy detection.
n Constant pressure connection method: If you need to check each pressure sensor and expiratory
valve, please follow the “constant pressure connection method” to connect the ventilator tubing set.
For the specific method, please connect according to the method described in the Section 6.2.5
Pressure sensor measurement accuracy detection.
2. If you check the O2 branch, you need to make sure that the gas supply pressure of the high-pressure O2
source is normal.
3. In the standby state, select the [Setup] key → [Maintain] → enter the manufacturer maintenance
password → [Diagnosis] to enter the [Valve Testing] menu.

Correspondence between the valve diagnostic tool interface and the components

To use the valve diagnostic tool to troubleshoot the sensor or valve, you must be familiar with the
correspondence between the actual gas circuit and the components on the hardware and the names of the valve
diagnostic tool interface.

Correspondence with the gas circuit components

The following figure reflects the correspondence between each sensor or valve in the valve diagnostic tool
interface and the actual components on the gas circuit schematic diagram.

7-21
Troubleshooting

List of key sensors or valves:


Symbol Name
Inspiratory.valve Inspiratory valve
PSOL Solenoid proportional valve (O2 proportional valve)
Q1 O2 flow sensor
Q2 Gas mixture flow sensor
Q3 Expiratory flow sensor
Pflow Expiratory pressure difference sensor
Exp.P Expiratory pressure sensor
Insp.P Inspiratory pressure sensor
Exp.Valve Expiratory valve
SV Safety valve

Correspondence with the hardware components

The following figure shows the connection diagram of the sampling tube connected to the actual sensor:

7-22
Troubleshooting

Troubleshooting methods for valve diagnostic tools

Using the valve diagnostic tool, you can perform abnormal diagnosis of the following items:
u Diagnosis of sensor zero point abnormality
u Diagnosis of abnormal connection of sensor sampling tube
u Diagnosis of abnormal state of inspiratory valve and O2 proportional valve
u Diagnosis of abnormal state of expiratory valve
u Diagnosis of abnormal state of safety valve

Diagnosis of sensor zero point abnormality

One function of the valve diagnostic tool is to easily detect whether the zero point of all pressure or flow
sensors on the machine is abnormal.
You can use the following steps to diagnose the sensor zero point abnormality:
1. Disconnect all gas supply sources, stop the turbine, disconnect the tubing set from the patient, and ensure
that the pressure and flow sensors are in a zero point environment.
2. In the [Valve Test] menu, check the actual measured value of each sensor in this state. If the actual value
is greater than 0.5, it means that the sensor needs to be performed with zero calibration.
3. If the actual measured value of each sensor is close to 0, observe its zero point AD value. If it is found
that the zero point AD of a sensor is not within the effective normal range, it means that the sensor is
7-23
Troubleshooting

faulty and the sensor needs to be replaced. After replacing the sensor, the zero calibration must be
performed again. If it is still not within the effective range after zero calibration, it means that the
monitoring board card is faulty and needs to be replaced and maintained.

Attention
l The normal range of the zero point AD of the expiratory pressure sensor: 967~1875;

l The normal range of the zero point AD of the inspiratory pressure sensor: 967~1875;

l The normal range of the zero point AD of the expiratory flow sensor: 150~330;

l The normal range of the zero point of the inspiratory flow sensor and the O2 flow sensor: -0.5
l/min~1 l/min.

Diagnosis of abnormal connection of sensor sampling tube

The expiratory flow sensor has two sampling tubes, and the abnormal connection is generally manifested as:
both tubes are reversely connected, a single tube is not connected, or both tubes are not connected.
The pressure sensor is a single sampling tube, and the abnormal connection is generally manifested as: a
single tube is not connected, or a single tube is connected incorrectly.
The valve diagnostic tool can be used to determine whether the sampling tube of the sensor is connected
abnormally. The specific methods and determination criteria are as follows:
n Determination of abnormal connection of the sampling tube of the expiratory flow sensor:
1. Enter the [Valve Test] menu and set the turbine pressure to 80cmH2O.
2. Gradually increase the DA settings of the inspiratory valve from small (inspiratory valve opening
flow rate: 10l/min), and the measured sampling AD value of the flow sensor shall gradually increase.
With the gradual increase of the actual gas supply:
u If it is found that the measured sampling AD value of a certain flow sensor is gradually
decreasing, it may be that the two sampling tubes of the flow sensor are connected reversely;
u If it is found that the measured sampling AD value of a certain flow sensor is close to the zero
point AD and remains unchanged, it may be that the two sampling tubes of the flow sensor are
not connected or the high-pressure sampling tube is not connected;
u If the low-pressure end of the flow sensor is not connected, the measured sampling AD value
of the flow sensor cannot be determined. Please disassemble and check if necessary.
3. If it is found that there is an abnormal connection of the sampling tube of the sensor, please refer to
the correspondence between 7.6.2.2 and hardware components in the connection diagram of the
sampling tube connected to the sensor to reconnect, and confirm the correctness of the connection
according to the above method.
n Determination of abnormal connection of pressure sensor sampling tube:
1. Enter the [Valve Test] menu and set the turbine pressure to 80cmH2O and the inspiratory valve
opening flow rate to 10l/min.
2. Gradually increase the DA settings of the expiratory valve from small, and observe whether the

7-24
Troubleshooting

measured sampling AD values of the expiratory pressure sensor and the inspiratory pressure sensor
gradually increase:
u If it is found that the measured sampling AD value of a certain pressure sensor changes very
little (less than 100AD), it may be that the pressure sensor sampling tube is not connected;
4. If it is found that there is an abnormal connection of the sampling tube of the sensor, please refer to
the correspondence between 7.6.2.2 and hardware components in the connection diagram of the
sampling tube connected to the sensor to reconnect, and confirm the correctness of the connection
according to the above method.

Diagnosis of abnormal state of inspiratory valve or O2 proportional valve

The valve diagnostic tool can be used to check whether the operating state of the inspiratory valve is
abnormal:
1. In the [Valve Test] menu, set the turbine pressure to 80cmH2O, and set the DA value of the inspiratory
valve to 0. If it is found that the measured values of the total branch flow sensor, expiratory flow sensor
and standard equipment are greater than 1l/min, it means that the inspiratory valve cannot be closed or
the valve drive circuit has a problem.
2. In the [Valve Test] menu, gradually increase the opening of the inspiratory valve (increase the flow rate
set value). If it is found that the measured values of the total branch flow sensor, expiratory flow sensor
and standard equipment have not changed much, and the airflow that can be felt from the expiration port
is also very small, it means that the inspiratory valve is faulty or the valve drive circuit is faulty.
3. In the positioning of whether it is the problem of the valve drive circuit, you can observe the state value
of the inspiratory valve in the [Valve Test] menu: With the increase of DA, the sampling value of the
state current of the inspiratory valve shall also increase, and when the inspiratory valve control DA is
adjusted to 2000, its state current sampling value shall be between 300 mA and 1100 mA. Otherwise, it
means there is a problem with the valve drive circuit of the inspiratory valve.
4. After replacing the inspiratory valve or monitoring board card, you can use the same method as above to
check whether the failure is repaired.
The valve diagnostic tool can be used to check whether the operating state of the O2 proportional valve is
abnormal:
1. Connect the high-pressure O2, and set the DA value of the O2 proportional valve to 0 in the [Valve Test]
menu. If the measured value of the O2 flow sensor is found to be greater than 1l/min, it means that the
O2 proportional valve cannot be closed or there is a problem with the valve drive circuit.
2. In the [Valve Test] menu, gradually increase the opening of the O2 proportional valve (increase the flow
rate set value). If it is found that the measured value of the O2 flow sensor does not change much, it
means that the O2 proportional valve is faulty or the valve drive circuit is faulty.
3. In the positioning of whether it is the problem of the valve drive circuit, you can observe the state value
of the O2 proportional valve in the [Valve Test] menu: With the increase of DA, the sampling value of
the state current of the O2 proportional valve shall also increase, and when the O2 proportional valve
control DA is adjusted to 1000, its state current sampling value shall be between 300 mA and 1100 mA.
7-25
Troubleshooting

Otherwise, it means there is a problem with the valve drive circuit of the O2 proportional valve.
4. After replacing the O2 proportional valve or monitoring board card, you can use the same method as
above to check whether the failure is repaired.

Diagnosis of abnormal state of expiratory valve

The valve diagnostic tool can be used to accurately check whether the operating state of the expiratory valve
is abnormal:
1. Enter the [Valve Test] menu and set the turbine pressure to 80cmH2O and the inspiratory valve opening
flow rate to 10l/min.
2. Set the DA value of the expiratory valve to 0. If the measured values of the expiratory pressure sensor,
inspiratory pressure sensor and standard equipment are all greater than 1cmH2O, it means that the
expiratory valve is faulty or the valve drive circuit is faulty.
3. Gradually increase the pressure set value of the expiratory valve, and the measurement of the expiratory
pressure sensor (and the connected ventilator calibration device) will increase accordingly. If it is found
that the measured values of the expiratory pressure sensor and standard equipment have not changed
much, the possible causes include expiratory valve failure, sampling tube detachment or problem with
the valve drive circuit.
4. It should be noted that when the DA of the expiratory valve is small (less than 1000), there is a
non-response zone. When DA is less than this zone, the expiratory valve may not be able to open and
always output 0; when DA exceeds this zone, as DA increases, the output gradually increases.
5. In the positioning of whether it is the problem of the valve drive circuit, you can observe the state value
of the expiratory valve in the [Valve Test] menu: With the increase of DA, the sampling value of the state
current of the expiratory valve shall also increase, and when the expiratory valve control DA is adjusted
to 2000, its state current sampling value shall be between 300 mA and 1100 mA. Otherwise, it means
there is a problem with the valve drive circuit of the expiratory valve.
6. After replacing the expiratory valve or monitoring board card, you can use the same method as above to
check whether the failure is repaired.

Diagnosis of abnormal state of safety valve

When the safety valve cannot be opened, that is, when it is normally closed, there will be a certain safety risk;
when the safety valve cannot be closed, that is, when it is normally open, the ventilator will not be able to
perform normal mechanical ventilation.
The valve diagnostic tool can be used to accurately check whether the safety valve can be opened and closed
normally.
1. Enter the [Valve Test] menu and set the turbine pressure to 80cmH2O.
2. Set the safety valve status to “open”, you can hear a slight “pop” sound.
3. Set the pressure of the expiratory valve to 50cmH2O and the valve opening flow rate of the inspiratory
valve to 5l/min. Observe the actual measured values of the expiratory flow sensor and expiratory
pressure sensor, which shall be close to 0 (less than 0.5). Otherwise, the safety valve cannot be opened
7-26
Troubleshooting

normally.
4. On the basis of the above operations, set the safety valve status to “off”; the measured value of the
expiratory flow sensor will be close to that of the inspiratory flow sensor, and the measured value of the
expiratory pressure sensor will be close to the valve opening pressure of the expiratory valve. Otherwise,
it means that the safety valve cannot be closed normally.
5. If the control of the safety valve is found to be abnormal, there may be a problem with the driving
voltage of the safety valve. You can observe the safety valve monitoring state value in the [Valve Test]
menu: When the safety valve is controlled to be closed, its state voltage value shall be between 0 V and
0.5 V; when the safety valve is controlled to be open, its state voltage value shall be between 9.5 V and
14.85 V. Otherwise, it means there is a problem with the valve drive circuit of the safety valve.
6. If the safety valve is faulty, replace the safety valve component. After replacement, you can use the same
method to confirm whether the failure is repaired.

Gas Circuit System Failure

The gas circuit system mainly includes a gas supply subsystem, an atomization subsystem, a turbofan
subsystem and a flow regulation subsystem, a safety valve subsystem, and an expiratory module. The
following describes the possible failures of the gas circuit system in the order of modules, and explains the
troubleshooting methods and the usual handling methods.

List of gas circuit failures

The list of gas circuit failures is as follows:


Serial Fault Possible cause Troubleshooting Reference
No. section
The output pressure of the Reset the output pressure of
The output pressure regulating valve is the pressure regulating
7.7.3.1 The
pressure of the set incorrectly. valve.
output pressure
pressure regulating If the pressure detection still
of the pressure
1. valve is inaccurate, The internal components fail fails to meet the
regulating
and the output due to aging (such as spring requirements even after
valve is
exceeds the range aging pressure drift/sealing setting up in the correct way,
inaccurate
of 190~210 kPa. ring aging leakage, etc.). replace the pressure
regulating valve.
The atomization tubing set is Clean or replace the 7.7.3.2
blocked. atomization tubing set. Atomization
2. Atomization fails. failure or
The atomization switch Replace the atomization
abnormal flow
valve is malfunctioning. switch valve.
rate

7-27
Troubleshooting

The atomization 7.7.3.2


flow is too small Atomization
The atomization needle Replace the O2 inlet
3. or too large, which failure or
valve is blocked. component.
is beyond the abnormal flow
range of 6-9l/min. rate
The maximum The O2 proportional valve is Replace the O2 proportional
7.7.3.3 The
flow output value malfunctioning. valve.
maximum flow
of the
output value of
high-pressure O2
4. The sintered copper filter at the
branch is too Replace the sintered copper
the high-pressure O2 inlet is high-pressure
small, and the flow filter.
blocked. O2 branch is
output is less than
smaller
120 l/min.
The low-pressure
The low-pressure O2 Replace the low-pressure O2
5. O2 connector is /
connector is damaged. connector.
loose and leaking.
The encapsulated filter mesh Replace the encapsulated 7.7.3.4 The
The measured flow is damaged. filter mesh. flow measured
of the O2 flow value of the O2
6.
sensor fluctuates The O2 flow sensor is flow sensor
Replace the O2 flow sensor.
greatly. damaged. fluctuates
greatly
The turbine is
malfunctioning. Replace the turbine box
The maximum The aging sponge blocks the component. 7.7.4.1 The
output flow is low, airway. maximum
7.
which is less than The filter mesh of the Replace the filter mesh of output flow is
180l/min. inspiratory valve is blocked. the inspiratory valve. smaller
The voice coil motor is Replace the inspiratory valve
malfunctioning. component.
The air/O2 flow sensor is
Replace the flow sensor.
damaged.
O2 concentration
Other parts are leaking (such Check the leakage point and
is inaccurate, with 7.7.4.2
as leakage at the connection eliminate the leakage, for
8. a deviation of > Inaccurate O2
between the turbine box and example, replacing the
(3% + 1% * set concentration
the inspiratory valve, the sealing ring, and checking
value).
flushing branch, and the whether the assembly is in
sampling branch of the O2 place.

7-28
Troubleshooting

sensor, etc.).
Replace the turbine box
The turbine box is leaking.
component.
Replace the inspiratory valve
The spring fails due to aging.
component.
The inspiratory valve
Replace the inspiratory valve
diaphragm fails due to aging
component.
or is damaged.
There are debris and other 7.7.4.3
Excessive leakage impurities in the sealing part Clean the inspiratory valve Excessive
9. of the inspiratory of the inspiratory valve diaphragm. leakage of the
valve diaphragm. inspiratory
The sealing cover valve
Replace the inspiratory valve
component of the inspiratory
component.
valve is stuck.
The valve port of the
Replace the inspiratory valve
inspiratory valve housing is
component.
damaged.
The voice coil motor is Replace the inspiratory valve 7.7.4.4 The
malfunctioning. component. response time
The inspiratory
of the
10. valve responds too The inspiratory valve
Replace the inspiratory valve inspiratory
slowly. diaphragm is sticky due to
component. valve is too
aging.
slow
The safety valve diaphragm
is damaged or improperly
installed.
The sealing ring on the
mainstream of the main body
of the safety valve is
Replace the damaged sealing
The safety valve is damaged or missing. 7.7.5.1 Safety
11. ring or reassemble the
leaking. The sealing ring on the valve leakage
sealing ring.
sampling branch of the main
body of the safety valve is
damaged or missing.
The sealing ring on the
safety valve plug is damaged
or missing.

7-29
Troubleshooting

The sealing ring at the


floating mechanism is
damaged or missing.
The electromagnet is
Replace the electromagnet.
malfunctioning.
The pressure relief
7.7.5.2 The
speed of the
pressure relief
pressure relief The safety valve diaphragm
speed of the
channel of the is not completely reset or the Replace the safety valve
12. pressure relief
safety valve is electromagnet is not diaphragm or electromagnet.
channel of the
slow, and the completely reset.
safety valve is
self-test of the
slow
safety valve fails.
The expiratory valve Replace the expiratory valve
diaphragm is damaged. diaphragm.
7.7.6.1
The expiratory The expiratory valve port is Replace the sterilizable
13. Expiratory
valve is leaking. damaged. expiratory valve component.
valve leakage
The voice coil motor is
Replace the voice coil motor.
malfunctioning.
The diaphragm fails or is Replace the sterilizable
ruptured. expiratory valve component.
The expiratory 7.7.6.2
The sampling tubing set or Replace the sampling tubing
flow has no Abnormal flow
14. the pressure sensor filter is set or the pressure sensor
measured value or test of the
blocked. filter.
large deviation. expiratory valve
The flushing branch is Replace the flushing branch
blocked. needle valve.
The O2 sensor has The O2 sensor is 7.7.7 The
Replace the O2 sensor.
a large malfunctioning. measurement
15.
measurement The sampling branch of the Clean the sampling branch error of O2
deviation. O2 sensor is blocked. of the O2 sensor. sensor is large

Gas source supply subsystem

Fault Possible cause Troubleshooting Reference section


The output pressure of The output pressure of Reset the output pressure
7.7.3.1 The output
the pressure regulating the pressure regulating of the pressure regulating
pressure of the pressure
valve is inaccurate, and valve is set incorrectly. valve.
regulating valve is
the output exceeds the The internal components If the pressure detection
inaccurate
range of 190~210 kPa. fail due to aging (such as still fails to meet the

7-30
Troubleshooting

spring aging pressure requirements even after


drift/sealing ring aging setting up in the correct
leakage, etc.). way, replace the pressure
regulating valve.
The atomization tubing Clean or replace the
7.7.3.2 Atomization
set is blocked. atomization tubing set.
Atomization fails. failure or abnormal flow
The atomization switch Replace the atomization
rate
valve is malfunctioning. switch valve.
The atomization flow is
7.7.3.2 Atomization
too small or too large, The atomization Replace the O2 inlet
failure or abnormal flow
which is beyond the air-resistor is blocked. component.
rate
range of 6-9l/min.
The maximum flow O2 proportional valve Replace the O2
output value of the failure proportional valve. 7.7.3.3 The maximum
high-pressure O2 branch flow output value of the
The sintered copper filter
is too small, and the flow Replace the sintered high-pressure O2
at the high-pressure O2
output is less than copper filter. branch is smaller
inlet is blocked.
120l/min.
The low-pressure O2
connector is loose and The low-pressure O2 Replace the low-pressure
/
leaking. connector is damaged. O2 connector.

The encapsulated filter Replace the encapsulated 7.7.3.4 The flow


The measured flow of the
mesh is damaged. filter mesh. measured value of the
O2 flow sensor fluctuates
The O2 flow sensor is Replace the O2 flow O2 flow sensor
greatly.
damaged. sensor. fluctuates greatly
The turbine is
malfunctioning. Replace the turbine box
The aging sponge blocks component.
The maximum output
the airway.
flow is low, which is less 7.7.4.1 The maximum
The filter mesh of the
than 180l/min. Replace the filter mesh output flow is smaller
inspiratory valve is
of the inspiratory valve.
blocked.
The voice coil motor is Replace the inspiratory
malfunctioning. valve component.
O2 concentration is The air/O2 flow sensor is
Replace the flow sensor. 7.7.4.2 Inaccurate O2
inaccurate, with a damaged.
concentration
deviation of > (3% + 1% Other parts are leaking Check the leakage point

7-31
Troubleshooting

* set value). (such as leakage at the and eliminate the


connection between the leakage, for example,
turbine box and the replacing the sealing
inspiratory valve, the ring, and checking
flushing branch, and the whether the assembly is
sampling branch of the in place.
O2 sensor, etc.).
The turbine box is Replace the turbine box
leaking. component.
The spring fails due to Replace the inspiratory
aging. valve component.
The inspiratory valve
Replace the inspiratory
diaphragm fails due to
valve component.
aging or is damaged.
There are debris and
7.7.4.3 Excessive
other impurities in the
Clean the inspiratory leakage of the
Excessive leakage of the sealing part of the
valve diaphragm. low-pressure
inspiratory valve inspiratory valve
proportional control
diaphragm.
valve
The sealing cover
Replace the inspiratory
component of the
valve component.
inspiratory valve is stuck.
The valve port of the
Replace the inspiratory
inspiratory valve housing
valve component.
is damaged.
The voice coil motor is
malfunctioning. 7.7.4.4 The response
The inspiratory valve Replace the inspiratory
The inspiratory valve time of the inspiratory
responds too slowly. valve component.
diaphragm is sticky due valve is too slow
to aging.
The safety valve
diaphragm Replace the damaged
049-001704-00 is sealing ring or
The inspiratory valve is damaged or improperly reassemble the sealing 7.7.5.1 Expiratory valve
leaking. installed. ring. leakage

The sealing ring on the


mainstream of the main

7-32
Troubleshooting

body of the inspiratory


valve 082-001763-00 is
damaged or missing.
The sealing ring on the
sampling branch of the
main body of the
inspiratory valve
082-001758-00 is
damaged or missing.
The sealing ring on the
inspiratory valve plug
082-001762-00 is
damaged or missing.

The sealing ring at the


safety valve mechanism
082-001762-00 is
damaged or missing.

The electromagnet is Replace the


malfunctioning. electromagnet.
The pressure relief speed The safety valve
7.7.5.2 The pressure
of the pressure relief diaphragm
Replace the safety valve relief speed of the
channel of the inspiratory 049-000654-00 is not
diaphragm or pressure relief channel
valve is slow, and the completely reset or the
electromagnet. of the safety valve is
self-test of the safety electromagnet is not
slow
valve fails. completely reset.
The expiratory valve Replace the expiratory
diaphragm is damaged. valve diaphragm.
Replace the differential
The expiratory valve is The expiratory valve port 7.7.6.1 Expiratory valve
pressure flow sensor
leaking. is damaged. leakage
component.
The voice coil motor is Replace the voice coil
malfunctioning. motor.
The expiratory flow has Replace the differential
The diaphragm fails or is 7.7.6.2 Abnormal flow
no measured value or pressure flow sensor
ruptured. test of the expiratory
large deviation. component.
valve
The sampling tubing set Replace the sampling

7-33
Troubleshooting

or the pressure sensor tubing set or the pressure


filter is blocked. sensor filter.
The flushing branch is Replace the flushing
blocked. branch needle valve.
The O2 sensor is
The O2 sensor has a Replace the O2 sensor.
malfunctioning. 7.7.7 The measurement
large measurement
Clean the sampling error of O2 sensor is
deviation. The sampling branch of
branch of the O2 sensor. large
the O2 sensor is blocked.

The output pressure of the pressure regulating valve is inaccurate

The function of the pressure regulating valve is to reduce the gas source pressure and stabilize the influence of
the fluctuation of the gas source pressure on the rear end. The long-term operation of the ventilator may cause
the output pressure of the pressure regulating valve to be inaccurate. Normally, the output pressure of the
pressure regulating valve needs to be checked under the following conditions:
1. Check the overall unit during maintenance on the client.
2. The ventilator malfunctions, for example, when the flow control drifts seriously.
The common tools needed to check and adjust the output pressure of the pressure regulating valve are as
follows:
1. 400kPa gas source (high-pressure gas cylinder with pressure regulating function).
2. Φ6 PU tube and quick-plug connector.
3. Ventilator analyzer VT-PLUS.
4. A set of socket wrenches and Allen wrenches.
The following figure shows the schematic diagram of the pressure regulating valve:

Pressure
regulating
valve

7-34
Troubleshooting

Pneumatic
atomization
interface

The adjustment method and steps of the output pressure at the rear end of the pressure regulating valve are as
follows:
1. Connect the gas source of the O2 cylinder and adjust the gas source pressure to 400±10kPa.
2. Connect the high-pressure port of the ventilator analyzer VT-PLUS to the atomization interface through
the PU tube and the quick-plug connector.
3. Open the atomization switch valve in the valve diagnostic tool in the manufacturer’s maintenance mode
of the ventilator, and adjust the O2 proportional valve to make the flow rate around 5l/min.
4. Observe the VT-PLUS reading, the reading shall be between 200±10kPa, otherwise the pressure
regulating valve needs to be adjusted.
5. Adjustment method of the pressure regulating valve: Use a socket wrench to loosen the hex nuts on the
front of the pressure regulating valve, and use an M3×20 Allen wrench to adjust the plastic screws. The
clockwise direction is to increase the pressure, and the counterclockwise direction is to decrease the
pressure. Pay attention to the value of the pressure gauge when adjusting. When the pressure reaches the
requirement, tighten the hex nuts. It should be noted that, during the process of tightening the hex nuts,
pay attention to the value of the pressure gauge. Usually the pressure will drop, and thus you need to
leave a certain margin in the initial adjustment of the pressure.
6. If the pressure detection still fails to meet the requirements even after setting up in the correct way, it
may be that some parts of the pressure regulating valve have failed, and the pressure regulating valve
needs to be replaced.

7-35
Troubleshooting

Atomization failure or abnormal flow rate

Atomization
switch valve

The function of the atomization switch valve is to realize the on-off of the atomizing airflow through on-off.
To determine whether the atomization function is normal, you can take the following steps to troubleshoot:
1. The machine is connected to a high-pressure O2 source or gas cylinder to ensure that the pressure of the
external gas source meets the requirements of the ventilator and that the gas source is sufficient.
2. Control the atomization switch in the valve diagnostic tool in the manufacturer’s maintenance mode, and
connect the ventilator analyzer VT-PLUS to the atomization nozzle through a PU tube, etc., to test
whether the atomization flow rate is normal: If there is no atomization flow rate and the failure still exists
after replacing the atomization tubing set, it may be that the atomization switch valve is faulty and needs
to be replaced. Control the atomization switch in the valve diagnostic tool in the manufacturer’s
maintenance mode, and reciprocate several times (3 times recommended) to see if you can hear a more
obvious “click” sound. If not, the atomization switch valve may be faulty and needs to be replaced. If the
atomization switch valve is normal, the atomization air-resistor may be blocked, and the O2 inlet
component needs to be replaced.
3. If there is an atomization flow rate, but the atomization flow rate is abnormal and exceeds the range of
6-9l/min, it may be that the atomization air-resistor is blocked and the O2 inlet component needs to be
replaced.

7-36
Troubleshooting

The maximum flow output value of the high-pressure O2 branch is smaller

Sintered copper
filter
O2 proportional
valve

The maximum flow output of the O2 inlet component is closely related to the performance of the O2
proportional valve. The possible failure of this valve is that the maximum flow output value of the
high-pressure O2 branch is too small. The valve failure can be troubleshot according to the following steps:
1. First, check whether the sintered copper filter is blocked. If a blockage is found, it needs to be replaced.
2. After checking the filter, connect the machine to an external gas source or O2 gas cylinder to ensure that
the pressure of the external gas source meets the requirements of the ventilator and that the gas source is
sufficient.
3. In the diagnosis mode, adjust the DA of the O2 proportional valve to 4095 to make the O2 proportional
valve fully open. At this time, observe whether the reading of the O2 flow sensor is greater than or equal
to 120l/min. If the maximum flow output value is too small, this situation is generally caused by the
internal failure of the proportional valve and needs to be replaced.

The flow measured value of the O2 flow sensor fluctuates greatly

If the flow measured value of the O2 flow sensor fluctuates greatly, refer to the following steps for
troubleshooting:
1. Use the self-test function of the overall unit for troubleshooting. If the O2 flow sensor fails the self-test, it
may be that the flow sensor is faulty, and the O2 flow sensor needs to be replaced.
2. Check whether the front filter mesh of the flow sensor is normal, otherwise replace it, and re-test to see
whether the measurement data is improved.

7-37
Troubleshooting

Turbofan subsystem and inspiratory flow regulating subsystem

The turbofan subsystem and inspiratory flow regulating subsystem are the core components of the machine,
which are mainly composed of two parts: turbine box components and a flow proportional control valve.

The maximum output flow is smaller

Enter the valve diagnosis function of the manufacturer's maintenance mode, adjust the control AD of the
inspiratory valve to 4095, and at the same time adjust the turbine speed to the maximum speed (44000-45000
rpm), and observe the reading of the total branch flow sensor at this time. If the reading deviates far from
180l/min, the turbine box component and the flow proportional control valve may be faulty. This problem is
more complicated and can be troubleshot as follows:
1. Close the inspiratory valve, adjust the turbine speed to 39600 rpm, and adjust the pressure to 80cmH2O.
Observe the “turbine detection speed”, “internal turbine temperature” and “external turbine temperature”
on the monitoring interface. If the turbine speed is much lower than 39600 rpm, or the turbine
temperature is higher than 85℃, the turbine may be faulty and the entire turbine box component needs to
be replaced.
2. If the turbine speed and operating temperature are normal, the turbine box component needs to be
removed and tested separately. The test principle is shown in the figure below. Connect the outlet of the
turbine box component with a bellows to the ventilator analyzer VT-PLUS or other flow testing
equipment, and use the valve diagnosis function of the manufacturer’s maintenance mode to adjust the
turbine speed to the maximum speed (44000-45000 rpm). If the reading of the flow equipment is greater
than 250l/min, the turbine box component is normal, and the failure shall be the flow proportional control
valve component, and the inspiratory valve component needs to be troubleshot. If the flow reading is less
than 250l/min, the turbine box component is faulty and needs to be replaced.
3. If it is located as a failure of the inspiratory valve component, please troubleshoot as follows. First check
the encapsulated filter mesh at the gas outlet of the inspiratory valve component. If it is found that the
encapsulated filter mesh is blocked, clean or replace the encapsulated filter mesh (049-001759-100). If
the problem still exists after replacing the encapsulated filter mesh (049-001759-00), the inspiratory
valve is faulty and the inspiratory valve components need to be replaced as a whole.

7-38
Troubleshooting

Encapsulated
filter mesh

Inaccurate O2 concentration

If the machine has defects with inaccurate O2 concentration, it can be troubleshot as follows:
1. Troubleshoot the air/O2 flow sensor and use the self-test function of the overall unit for troubleshooting.
If the self-test function of “O2 flow sensor test” and “inspiratory flow sensor test” of the overall unit fails,
the air/O2 flow sensor may be faulty and needs to be replaced.
2. Check the leakage of other components except the turbine box. The main troubleshooting sites are the
connection between the turbine box and the inspiratory valve, the leakage of the flushing branch, and the
leakage of the O2 sensor sampling branch. If a leak is found, the parts need to be reassembled, or the
sealing element must be replaced.
3. Check if any tubing set is disconnected or loose. The main troubleshooting sites are the expiratory valve
flushing branch and the O2 sensor sampling branch. If the tubing set is found to be unconnected or loose,
it needs to be reconnected.
4. If the problem still exists after the first 3 steps of troubleshooting, it may be that the turbine box
component is leaking and the turbine box component needs to be replaced.

Excessive leakage of the inspiratory valve

The leak test method of the inspiratory valve is as follows:


Enter the valve diagnosis mode of the manufacturer’s maintenance mode, adjust the DA of the inspiratory
valve to 0, and set the turbine speed to 39600 rpm. At this time, observe the reading of the flow sensor of the
total branch. If the reading is greater than 0.1l/min, the leakage of the inspiratory valve is beyond the standard.
Please follow the steps below for troubleshooting:
7-39
Troubleshooting

1. Disassemble the inspiratory valve housing and check whether there are debris and other impurities at the
inspiratory valve diaphragm. If there are debris and other impurities in the sealing part of the inspiratory
valve diaphragm, wipe or clean the diaphragm. When installing the inspiratory valve housing, be careful
not to miss the encapsulated filter mesh.
2. If the problem persists after cleaning the inspiratory valve diaphragm, the inspiratory valve component
may be faulty and needs to be replaced.
Inspiratory valve
diaphragm
Encapsulated filter
mesh

The response time of the inspiratory valve is too slow

The response time of the inspiratory valve is too slow. There are two main causes:
u The voice coil motor is malfunctioning.
u The inspiratory valve diaphragm is damaged or contaminated, and it adheres to the valve port, affecting
the opening of the valve port.
If you find that the response time of the inspiratory valve is too slow, take the following steps for
troubleshooting:
1. Disassemble the inspiratory valve housing and check whether there are debris and other impurities at the
inspiratory valve. If the sealing part of the inspiratory valve diaphragm is contaminated, wipe or clean the
diaphragm. When installing the inspiratory valve housing, be careful not to miss the encapsulated filter
mesh.
2. If the problem persists after cleaning the inspiratory valve, the inspiratory valve component may be
faulty and needs to be replaced.

7-40
Troubleshooting

Inspiratory valve component

Inspiratory valve leakage

If the inspiratory valve leaks, it can be troubleshot according to the following conditions:
1. If there is a more obvious leakage sound, you can listen to the sound and find the leakage point to
confirm the faulty part.
2. Take out the detachable part of the inspiratory valve, and visually inspect whether the sealing ring on the
inspiratory valve is missing or damaged. If the above situation occurs, the sealing ring needs to be
replaced; for the position of the sealing ring, please refer to the explosive view of the detachable part of
the inspiratory valve.
3. Install the detachable part of the inspiratory valve into the machine, and control the safety valve switch in
the valve diagnostic tool in the manufacturer’s maintenance mode, and reciprocate several times (3 times
recommended) to see if you can hear a more obvious “click” sound. If not, it may be that the
electromagnet is faulty and needs to be replaced.

The pressure relief speed of the pressure relief channel of the inspiratory valve is slow

If the “safety valve test” fails in the system self-test, it can be troubleshot according to the following
conditions:
1. First troubleshoot whether the inspiratory valve is leaking, please refer to 7.7.5.1 Inspiratory valve
leakage for the troubleshooting method.
2. Check whether the dust-proof cushion of the inspiratory valve is blocked. If the dust-proof cushion is
blocked, it needs to be replaced.
3. Remove the detachable part of the inspiratory valve, observe the safety valve diaphragm gasket
041-005410-00, use your fingers to push the safety valve diaphragm component, after releasing your
fingers, check whether the safety valve diaphragm component is stuck. If it is stuck, it needs to be
replaced.
4. Disassemble the safety valve seat, take out the safety valve diaphragm component, and observe whether
7-41
Troubleshooting

the safety valve diaphragm is installed correctly. If the client is not installed correctly, the safety valve
diaphragm needs to be reinstalled.
5. Under the power-on condition, observe whether the electromagnet valve rod can be pulled to the end. If it
cannot be pulled to the end, the electromagnet is faulty and needs to be replaced.

Expiratory valve component

Expiratory valve leakage

If the expiratory valve leaks, it can be troubleshot according to the following conditions:
1. If there is a more obvious leakage sound, you can listen to the sound and find the leakage point to
confirm the faulty part.
7-42
Troubleshooting

2. Take out the sterilizable expiratory valve component and visually inspect the expiratory valve diaphragm
to see if it is damaged. If the expiratory valve diaphragm is damaged, it needs to be replaced.
3. Remove the expiratory valve diaphragm and visually inspect the expiratory valve port if there is a gap at
the valve port. If there is a gap at the valve port, it needs to be replaced.
4. Install the sterilizable expiratory valve component into the machine, connect the outlet of the expiratory
valve and the outlet of the inspiratory valve with a bellows, use the valve diagnostic tool in the
manufacturer’s maintenance mode to adjust the turbine component and the inspiratory valve to produce
an output flow of 2l/min, while adjusting the expiratory valve pressure to 80cmH2O. Observe whether
the pressure reading of the expiratory valve branch can reach 80cmH2O. If it cannot be reached, the
voice coil motor may be faulty and needs to be replaced.

Expiratory valve
diaphragm

Expiratory valve
port

Abnormal flow test of the expiratory valve

The flow test of the expiratory valve is abnormal, and the sampling branch has no flow sampling data or large
deviations. It can be troubleshot according to the following conditions:

7-43
Troubleshooting

1. Observe whether the metal diaphragm of the flow sensor is normal. If the metal diaphragm of the flow
sensor has been broken or damaged, the metal diaphragm of the flow sensor needs to be replaced. The
metal diaphragm of the flow sensor cannot be replaced individually, and the differential pressure flow
sensor components need to be replaced as a whole.
2. Check whether the flushing branch and flushing needle valve are blocked. If they are blocked, they need
to be cleaned or replaced. The method to check whether the flushing branch is blocked is as follows:
Unplug the silicone hose from the sampling port of the expiratory valve, enter the valve diagnosis
function in the manufacturer’s maintenance mode, and adjust the turbine speed to 39600 rpm. Put one
end of the hose into a water container. If blisters appear at the end of the hose, the flushing branch is
normal. If no bubbles appear at the end of the hose, the flushing branch is blocked or not connected
properly and needs to be cleaned or replaced. This method can be used to check whether the tubing sets
of each part of the expiratory valve sampling port, pressure sensor interface, etc. are blocked or not
properly connected at one time.

Normal diaphragm
Damaged
diaphragm

The measurement error of O2 sensor is large

The main function of the O2 sensor is to detect the O2 concentration. The possible failure of this component is
the failure of the O2 sensor. For the problem of O2 sensor failure, a preliminary judgment can be made
according to the cycle of replacing the O2 sensor once a year. If the replacement time is short and the O2
concentration detection is not accurate, you need to perform O2 concentration calibration. If the O2
concentration monitoring is still inaccurate, it is necessary to judge whether the O2 sensor is faulty. The
judgment method and steps are as follows:
1. The machine is connected to a high-pressure O2 source, and at the same time, check whether the HEPA
filter at the air inlet is blocked. If the high-pressure O2 source is not connected, or the HEPA filter is
blocked, it may cause the O2 sensor test to fail.
2. Using the system self-test function, if the result of “O2 sensor test” in the system self-test function is
“pass”, the O2 sensor is not damaged. If the result is “fail”, the O2 sensor is damaged and needs to be
replaced.
3. If the problem still exists after replacing the O2 sensor with a new one, it may be that the sampling
tubing set of the O2 sensor is blocked. It is recommended to clean or replace the sampling tubing set.

Hardware and Electrical System Failure

Fault Possible cause Troubleshooting

7-44
Troubleshooting

No AC power supply is connected, and the Check and ensure that the AC power
battery power is low. supply is properly connected.
When the machine Replace the fuse. If the failure still exists
is turned on, the The AC input socket fuse is blown, and the when the machine is turned on after
running indicator, battery power is low. replacing the fuse, it means that there is a
AC indicator, and short circuit inside the machine.
battery indicator The display cable (on the motherboard or Check to ensure that the cable is reliably
are off, and there the external connector of the main unit) is connected, and ensure that the fastening
is no display on detached or the connection is unreliable. screws of the display cable are tightened.
the screen, that is, The cables related to the power switch are Check to make sure that the cables are
the ventilator disconnected or unreliable. connected reliably.
cannot be started. The circuit failure of the AC-DC board
hardware results in no 24V power output Replace the AC-DC board.
and insufficient battery power.
When the machine
is turned on, the
AC indicator and
battery indicator The circuit failure of the DC-DC board
are on, but the hardware causes no DC power output such Replace the DC-DC board.
running indicator as 3.3V, 5V, 7V, 12V, etc.
is off, and there is
no display on the
screen.
The hardware failure of the main control
board causes the backlight enable signal to Replace the main control board.
The screen does output an invalid level.
not display (blank The software failure of the main control
screen). board causes the backlight enable signal to Upgrade the main control board software.
output an invalid level.
The LCD is damaged. Replace the LCD.
The display cable (at the LCD) is Check to make sure that the cables are
disconnected or the connection is unreliable. connected reliably.
The screen does
The hardware failure of the main control
not display (white
board causes the LCD power supply 3.3V to Replace the main control board.
screen).
have no output or abnormal output.
The LCD is damaged. Replace the LCD.
There is a display The display cable (at the LCD) is Check to make sure that the cables are
on the screen, but disconnected or the connection is unreliable, connected reliably.

7-45
Troubleshooting

one or several causing some color signals to be lost.


display colors are
abnormal (blurred
screen).
The hardware failure of the DC-DC board
Check to make sure that the cables are
causes the backlight brightness adjustment
connected reliably.
The screen signal to fail to output a normal signal.
brightness cannot The hardware failure of the main control
be adjusted. board causes the backlight brightness
Replace the main control board.
adjustment signal to fail to output a normal
signal.
The alarm indicator does not light up. The
Check to make sure that the cables are
display cable is disconnected or the
connected reliably.
connection is unreliable.
The cable of the alarm indicator board is Check to make sure that the cables are
The alarm detached or the connection is unreliable. connected reliably.
indicator does not The hardware failure of the main control
light up. board makes it impossible to output normal Replace the main control board.
alarm indicator control signals.
The hardware failure of the alarm indicator
board makes it impossible to drive the alarm Replace the alarm indicator board.
indicator.
The key-related cable is detached or the Check to make sure that the cables are
connection is unreliable. connected reliably.
The key is
The hardware failure of the key control
malfunctioning.
board causes it to fail to respond to the input Replace the key control board.
information of the keys.
The cable of the encoder board is detached Check to make sure that the cables are
or the connection is unreliable. connected reliably.
The rotary
The rotary encoder is damaged. Replace the rotary encoder.
encoder is
The hardware failure of the key control
malfunctioning.
board causes it to fail to respond to the input Replace the key control board.
information of the rotary encoder.
The touch screen-related wires are detached Check to make sure that the cables are
or the connection is unreliable. connected reliably.
The touch screen
The hardware failure of the key control
is malfunctioning.
board causes it to fail to respond to the input Replace the key control board.
information of the touch screen.

7-46
Troubleshooting

The touch screen is damaged. Replace the touch screen.


The speaker-related wires are detached or Check to make sure that the cables are
the connection is unreliable. connected reliably.
The speaker is The hardware failure of the main control
malfunctioning. board makes it impossible to output normal Replace the main control board.
speaker drive signals.
The speaker is damaged. Replace the speaker.
Re-plug the wifi antenna or replace the
The Wi-Fi antenna is detached or broken.
antenna.
The Wifi module
The Wifi module is damaged. Replace the wifi module.
works abnormally.
The monitoring motherboard is Replace the monitoring module board
malfunctioning. card component.
The cable between the CO2 module and the
monitoring motherboard is detached or Re-plug or replace related wires.
The mainstream or
disconnected.
sidestream CO2
The CO2 module itself is malfunctioning. Replace the CO2 module.
module is
The serial communication on the
abnormal. Replace the motherboard component of
motherboard of the monitoring module is
the monitoring module.
abnormal.
The cable between the SpO2 module and
the monitoring motherboard is detached or Re-plug or replace related wires.
disconnected.
The SpO2 module
The SpO2 module itself is malfunctioning. Replace the SpO2 module.
is abnormal.
The serial communication on the
Replace the motherboard component of
motherboard of the monitoring module is
the monitoring module.
abnormal.
Check the fan blockage and remove the
The fan is blocked.
obstruction.
The cooling fan The fan cable is disconnected or the fan is
Re-plug the fan cable or replace the fan.
does not rotate. malfunctioning.
The 12V power supplied by the DC-DC
Replace the DC-DC board.
board to the fan is damaged.
The turbofan is damaged. Replace the turbofan component.
The turbofan does Replace the motherboard component of
The turbine drive circuit is abnormal.
not turn. the monitoring module.
The DC-DC board is malfunctioning. Replace the DC-DC board.

7-47
Chapter 8 Maintenance and Disassembly

Preparation for Disassembly

VDisassembly tools

In the process of disassembling and replacing parts, you may need to use the following tools:
u A set of metric Allen wrenches (2.5#, 3#, 4#, 5#, 6#)
u Phillips screwdriver
u Diagonal pliers
u Slotted screwdriver
u Adjustable wrench

Preparations

Before disassembling the ventilator, please make the following preparations:


u Make sure that the ventilator is turned off, and disconnect the AC power supply and backup battery.
u Unplug all accessories connected to the ventilator.
u Disconnect the pipe gas source and the spare gas cylinder.
u Prepare the disassembly tools.
u When disassembling the board card, wear anti-static gloves or a wristband for ESD protection.
u Move the ventilator to a suitable disassembly environment. If a trolley is equipped, please step on the
brake plate of the casters to fix the ventilator.

Disassembly of Maintenance Spare Parts

Disassembling the lithium battery

1. Turn the machine down, remove the 4 M3X8 drop-resistant screws that fix the battery compartment door
of the main unit from the bottom, and remove the battery compartment door.

8-1
Maintenance and Disassembly

Battery compartment
door of the main unit

2. Pull the sheet and take out the lithium battery.

Pull out the


sheet from
here to
remove the
battery.

Replacing the O2 battery

1. Pry open the O2 battery cover, press the O2 battery holder to unlock it and pull out the O2 battery holder.
2. Unplug the O2 battery cable from the O2 battery, and then unscrew the O2 battery counterclockwise.
3. Follow the relevant steps to reinstall the O2 battery.

8-2
Maintenance and Disassembly

Pry from
here. Press to
unlock and
pull out,
unplug the
cable, and
unscrew the
O2 battery.

Disassembling the high-efficiency filter and fan dust screen

1. Press the buckle of the air inlet baffle of the main unit and take out the air inlet baffle of the main unit.

Buckle

Air inlet baffle of


the main unit

2. Press the buckle of the high-efficiency filter and take out the high-efficiency filter. If you replace the fan
8-3
Maintenance and Disassembly

dust screen, remove the fan dust screen and replace it.

Fan dust High-effici


screen ency filter

Disassembling the expiratory valve diaphragm and expiratory check valve

1. As in 8.2.5, disassemble the sterilizable expiratory valve component.


2. Pull out the expiratory valve diaphragm and expiratory check valve from the rear end of the sterilizable
expiratory component.

Expiratory valve diaphragm

One-way diaphragm of expiratory valve

Disassembling the sterilizable parts of the safety valve

1. As in 8.2.4, disassemble the sterilizable parts of the safety valve.


2. Disassemble the sterilizable parts of the inspiratory valve as shown in the figure below.
8-4
Maintenance and Disassembly

Disassembling the upper shell component

1. Use a slotted screwdriver to open the upper shell screw plug of the main unit.

2. Remove the 3 M3X8 round head screws and 2 M3X6 countersunk head screws that fix the upper shell.
Take out the upper shell component.

8-5
Maintenance and Disassembly

Disassembling the horn

1. As in 8.2.25, disassemble the kernel component.


2. Unplug the speaker cable, loose 2 M3X8 combination screws that fix the speaker, and take out the horn
component.
3. Press the two buckles on both sides of the horn bracket to take out the horn.

Horn cable

Buckle

Horn bracket

Disassembling the WIFI module

1. As in 8.2.6, disassemble the upper shell component.


2. Unplug the antenna on the WIFI module. Loose the M3X6 round head screws with machine teeth on the
board card, and take out the WIFI module.

8-6
Maintenance and Disassembly

WIFI
module

Disassembling the SpO2 module

1. As in 8.2.25, disassemble the kernel component.


2. Pull out the wire connected to the SpO2 module, loose 4 M3X8 combination screws that fix the SpO2
module, and take out the SpO2 module.

8-7
Maintenance and Disassembly

Disassembling the display component

After disassembling the upper shell component according to 8.2.7, disassemble the 4 M4X12 combination
screws that fix the display component, unplug the display screen cable and key board cable, and take out the
display component from the front.
Display screen cable and key
board cable

Display
component

Disassembling the front shell of the main unit

1. Disassemble the lithium battery as in 8.2.1, and disassemble the display component as in 8.2.10.
2. As in 8.2.4, disassemble the sterilizable expiratory valve component and detachable parts of the safety
valve.
3. Pry off the 4 screw plugs on the front shell of the main unit on the front shell and unscrew the 4 M3X8
combination screws under the screw plugs, and take out the front shell of the main unit.

8-8
Maintenance and Disassembly

Disassembling the monitoring board card component

1. As in 8.2.12, disassemble the front shell of the main unit.


2. Unplug the wire connected to the monitoring board card component, and loosen the 8 M3X8
combination screws that fix the monitoring board card component.
3. Take out the monitoring board card component.

Disassembling the rear shell of the display and key control board

1. After disassembling the display component as in 8.2.11, use a slotted screwdriver to pry off the 4 screw
plugs on the rear shell of the display.
2. Remove the 4 M3X8 combination screws that fix the rear shell of the display and the 6 M3X8
combination screws that fix the display shaft, and take out the rear shell.
3. Remove the 3 M3X6 screws that fix the key control board, unplug the wire connected to the key control
8-9
Maintenance and Disassembly

board, and take out the key control board.

Disassembling the alarm indicator board

After disassembling the rear shell of the display as in 8.2.14 Disassembling the rear shell of the display and
key control board, remove the two M3X6 self-tapping screws on the alarm indicator board, pull out the cable
of the alarm indicator board, and take out the alarm indicator board.

Disassembling the display screen component

1. After the steps as in 8.2.14 Disassembling the rear shell of the display and key control board, remove the
4 M3X8 combination screws that fix the screen bracket and the 4 M2X4 screws that fix the display.
2. Use an electric blower to heat the surrounding area between the display front shell and the display
component. After the 3M adhesive under the display component is heated and softened, take out the
display component.

Disassembling the shuttle board

1. Disassemble the rear shell according to the steps as in 8.2.14 Disassembling the rear shell of the display
and key control board.
2. Unplug the cable connected to the shuttle board.
3. Use a No. 1 screwdriver to tilt the knob out, use an adjustable wrench to remove the nuts that fix the
shuttle, remove the two M3X6 self-tapping screws on the shuttle board, and take out the shuttle board.

Replacing the pressure sensor filter

1. Disassemble the front shell of the main unit as in 8.2.11.


2. Unplug the tubing set connected to the filter.
3. After replacing the new filter, connect the tubing set according to the connection diagram.

Pressure sensor filter

8-10
Maintenance and Disassembly

Disassembling the inspiratory valve seat component

1. Disassemble the front shell of the main unit as in 8.2.11.


2. Unscrew the 4 M3X8 combination screws that fix the inspiratory valve seat, and take out the inspiratory
valve seat component.
3. Unplug the electromagnet cable and inspiratory pressure sampling tube.

Electromagnet connection
plug

Disassembling the electromagnet

1. As in 8.2.20, disassemble the inspiratory valve seat component.


2. Remove the 4 M3X8 combination screws that fix the electromagnet, and take out the electromagnet.

Electromagnet

Disassembling the air flow sensor

1. After disassembling the safety valve seat component as in 8.2.21, pull out the air flow sensor connected
to the safety valve seat, cut off the cable tie, and unplug the sensor cable.

8-11
Maintenance and Disassembly

Air mass flow


sensor

Disassembling the sensor adapter board

1. Disassemble the front shell of the main unit as in 8.2.12.


2. Unplug the 5 gas pipes connected to the sensor adapter board, and unplug the cable on the sensor adapter
board.
3. Remove the 5 M3X8 combination screws that fix the sensor adapter board, and take out the sensor
adapter board.

8-12
Maintenance and Disassembly

Disassembling the O2 battery holder component

1. Pull out the O2 battery holder as in 8.2.2, and screw out the O2 battery.
2. Turn down the machine (as shown in the figure), unscrew the 2 M3X6 countersunk head screws that fix
the component, unplug the gas pipe of the O2 battery holder component (connected according to the pipe
number in the pipe connection diagram during assembly), and take out the O2 battery holder component.

Disassembling the kernel component

Attention: After kernel is disassembled and reinstalled, the wires and gas pipes must be arranged so that they
cannot be hooked to loosen the connectors.
1. Disassemble the front shell of the main unit as in 8.2.12.
2. Disassemble the air inlet baffle of the main unit as in 8.2.3.
3. Take out the external guide groove of the expiratory valve from the left side of the machine.

8-13
Maintenance and Disassembly

Pry from here.

4. Unscrew the 2 M3X8 combination screws and 2 M3X6 countersunk head screws of the kernel
component from the back of the machine.
5. Unscrew the 3 M3X6 countersunk head screws of the kernel component from the bottom of the machine.

Disassembling the AC-DC power panel

1. Disassemble the kernel component as in 8.2.24.


2. Unscrew the 6 M3X8 combination screws that fix the AC-DC power supply bracket from the front and
right sides of the kernel.

3. After unplugging the connected wires, take out the AC-DC power supply bracket and AC-DC power

8-14
Maintenance and Disassembly

panel, unscrew the 4 M3X8 combination screws that fix the AC-DC power panel, and take out the
AC-DC power panel.

Disassembling the DC-DC power panel

1. Disassemble the AC-DC power panel as in 8.2.25 Disassembling the AC-DC power panel.
2. Unscrew the 6 M3X8 combination screws that fix the DC-DC power panel, unplug the connected wires,
and take out the DC-DC power panel.

Disassembling the fan

1. Disassemble the DC-DC power panel as in 8.2.27.


2. Unscrew the two M4X20 round head screws with machine teeth that fix the fan from the front of the
kernel, and take out the fan.

8-15
Maintenance and Disassembly

Disassembling the AC power socket

1. Disassemble the AC-DC power supply bracket as in 8.2.26 Disassembling the AC-DC power panel.
2. Loosen 1 M4 nut that fixes the ground wire, and use a slotted screwdriver to open it. Take out the AC
power socket from the back.
3. Pry the fuse cover from the AC power socket to replace the fuse. (Attention: If you only replace the fuse,
you do not need to disassemble the machine and replace it directly outside the machine.)

Pry from the inside

Pry from here to replace the fuse

8-16
Maintenance and Disassembly

Disassembling the DC input socket

1. Disassemble the AC-DC power supply bracket as in 8.2.25 Disassembling the AC-DC power panel.
2. Loosen the nuts that fix the DC input socket with an adjustable wrench, unplug the DC input cable from
the DC-DC power panel, and take out the DC input socket from the outside of the machine.

Nut
DC input
socket

Disassembling the expiratory valve seat component

1. Disassemble the kernel component as in 8.2.25.


2. Loosen the 4 M3X8 combination screws that fix the expiratory valve seat from the front and side of the
kernel component, unplug the cable of the voice coil motor, take out the expiratory valve seat component,
and the wires are arranged as shown in the figure during rearrangement.

Disassembling the voice coil motor of the expiratory valve

1. Disassemble the expiratory valve seat component as in 8.2.31 Disassembling the expiratory valve seat
component.
2. Loosen the 3 M3X8 combination screws that fix the voice coil motor from the inside of the valve seat.

8-17
Maintenance and Disassembly

Disassembling the sidestream CO2 module (optional)

1. Disassemble the kernel component as in 8.2.25.


2. Loosen the 2 M3X8 combination screws that fix the CO2 module from the side of the machine, unplug
the wire connected to the CO2 module, and take out the CO2 module.

Disassembling the turbine box component

1. Disassemble the kernel component as in 8.2.25.


2. Unplug all wires connected to the monitoring motherboard.
Attention: After changing the turbine, please go to the manufacturer maintenance to reset the turbine
running time.

8-18
Maintenance and Disassembly

1. Remove the 6 M3X8 combination screws around the top plate of the fixing bracket, and take out the top
plate of the bracket.
2. Use an Allen wrench to remove the 4 stepped screws that fix the turbine box component (Attention: the
other screws on the turbine box component cannot be removed).
3. Unplug the wire of the negative pressure sensor board on the turbine box component, and take out the
turbine box component from above.
4. Remove the negative pressure sensor board, unplug the wire connected to the board card, loosen the 2
M3X8 combination screws that fix the board card, and take out the board card.

Negative pressure
sensor cable

Disassembling the expiratory valve component

1. Disassemble the turbine box component as in 8.2.34.


2. Loosen the 3 M3X8 combination screws that fix the inspiratory valve component, pull out the gas pipe,

8-19
Maintenance and Disassembly

and take out the low-pressure valve component upwards after the whole component is retracted.

Gas pipe

Disassembling the encapsulated filter mesh

1. Disassemble the low-pressure valve component as in 8.2.35.


2. Use tweezers to take out the encapsulated filter mesh from the valve outlet, and pay attention to the
alignment of the filter notch and the air inlet when reinstalling.

The notch is aligned with the vent

Disassembling the O2 inlet component

1. Disassemble the turbine box component as in 8.2.34.


2. Unscrew the 2 M3X8 combination screws that fix the O2 inlet component from the back of the machine,

8-20
Maintenance and Disassembly

and pull out the O2 inlet component.


3. Unplug the gas pipe connected to the O2 inlet component.

1. Unplug the O2 flow sensor wire from the front of the machine, and pull out the O2 sensor component.

O2 flow sensor cable

Disassembling the proportional valve and atomization valve

1. Disassemble the O2 inlet component as in 8.2.31.


2. Use a 2.5# Allen wrench to unscrew the 4 M3X20 hexagon socket screws that fix the proportional valve
and the atomization valve, disconnect the cable between the valve and the monitoring board, and take out
the proportional valve and the atomization valve respectively.

8-21
Maintenance and Disassembly

Disassembling the pressure regulating valve component

1. Disassemble the O2 inlet component as in 8.2.31.


2. Loosen the 2 M3 hexagon socket screws that fix the pressure regulating valve component (Attention: Do
not loosen the other 2 screws of the pressure regulating valve).

Disassembling the O2 flow sensor

1. Disassemble the O2 inlet component as in 8.2.31.


2. Loosen the 2 M3X8 combination screws that fix the fixing sheet metal of the O2 flow sensor. Take out the
O2 sensor and encapsulated filter mesh.

8-22
Maintenance and Disassembly

Pay attention to the direction of the arrow


for installation

Encapsulated filter mesh

Disassembling the low-pressure O2 connector

1. Disassemble the O2 inlet component as in 8.2.38.


2. Unplug the gas pipe connected to the low-pressure O2 connector, loosen the fixing nut of the
low-pressure O2 with an adjustable wrench, and take out the low-pressure O2 connector.

8-23
Maintenance and Disassembly

Disassembling the battery adapter board

1. Disassemble the kernel component as in 8.2.25.


2. Loosen the 4 M3X8 combination screws that fix the battery adapter board from the front of the machine,
and take out the battery adapter board.

Disassembling the rear shell

1. Disassemble the kernel component as in 8.2.25.


2. After the kernel component is removed, the rear shell remains.

Disassembling the mainstream CO2 + SpO2 connector component (optional)

1. Disassemble the kernel component as in 8.2.24.


2. Loosen the 3 M3X6 round head screws that fix the CO2 + SpO2 connector component, unplug the
connected wire, and take out the CO2 + SpO2 connector component.

8-24
Maintenance and Disassembly

CO2 + SpO2 connector component

Disassembling the WIFI antenna (optional)

Pull out the socket antenna on the WIFI module, and tear off the WIFI antenna directly from the plastic shell.

WIFI
antenna

Disassembling the sidestream CO2 + SpO2 connector (optional)

1. Disassemble the kernel component as in 8.2.24.


2. Loosen the 3 M3X6 round head screws that fix the sidestream CO2 + SpO2 connector component, unplug the
connected wire and pipe, and take out the sidestream CO2 + SpO2 connector component.

8-25
Maintenance and Disassembly

Sidestream CO2 + SpO2 connector component

Disassembling the trolley support platform component

1. Remove the 5 screws on the top surface of the platform;


2. Take out the support platform component as shown in the figure below;

Disassembling the trolley handle component

1. Remove the fixing screws between the linear guide rail and the column;
2. Take out the trolley handle component as shown in the figure below;

8-26
Maintenance and Disassembly

Disassembling the trolley column

1. Remove the fixing screws on the back of the chassis;


2. Remove the trolley column as shown in the figure below;

Disassembling the trolley chassis component

As the above operation, you can take out the chassis component;

Disassembling the humidifier fixing component

1. Remove the 4 screws fixed to the column;


2. Remove the humidifier fixing component as shown in the figure below;

8-27
Maintenance and Disassembly

Disassembling the trolley gas cylinder fixing component

1. Remove the 4 screws fixed to the column;


2. Remove the 4 screws matching the chassis;
3. Remove the humidifier fixing component as shown in the figure below;

Disassembling the trolley lock control component

1. Remove the screws between the platform and the fixed seat of the pulley mechanism, and remove the
platform parts;
2. Obtain the trolley lock control component;

8-28
Chapter 9 Circuit and Gas Circuit Connection

Gas Circuit Connection

Gas circuit connection diagram

Low-pressure proportional control valve


O2 battery component

Flushing component

Acquisition board

Inspiratory valve

Gas source inlet component

Atomization interface
Expiratory valve

Gas circuit list

Gas circuit components, and overall unit materials


No. Name Tube Subordinate Single unit Length mm Material code
diameter components usage
1 Sampling silicone 4.0*2.0 Overall unit 1 100mm 082-000523-00
tube
2 Sampling silicone 4.0*2.0 Overall unit 1 35mm 082-000523-00
tube
3 Sampling silicone 4.0*2.0 Overall unit 1 35mm 082-000523-00
tube
4 Sampling silicone 4.0*2.0 Overall unit 1 100mm 082-000523-00
tube

9-1
Circuit and Gas Circuit Connection

5 Sampling silicone 4.0*2.0 Overall unit 1 35mm 082-000523-00


tube
6 Sampling silicone 4.0*2.0 Overall unit 1 100mm 082-000523-00
tube
7 Sampling silicone 4.0*2.0 Overall unit 1 100mm 082-000523-00
tube
8 Sampling silicone 4.0*2.0 Overall unit 1 35mm 082-000523-00
tube
9 Sampling silicone 4.0*2.0 Overall unit 1 35mm 082-000523-00
tube
10 Sampling silicone 4.0*2.0 Overall unit 1 100mm 082-000523-00
tube
11 Sampling silicone 4.0*2.0 Overall unit 1 150mm 082-000523-00
tube
12 Sampling silicone 4.0*2.0 Overall unit 1 150mm 082-000523-00
tube
13 Sampling silicone 4.0*2.0 Overall unit 1 15mm 082-000523-00
tube
14 Sampling silicone 4.0*2.0 Overall unit 1 15mm 082-000523-00
tube
15 Sampling silicone 4.0*2.0 Overall unit 1 15mm 082-000523-00
tube
16 Sampling silicone 4.0*2.0 Overall unit 1 15mm 082-000523-00
tube
17 Sampling silicone 3.0*1.0 Overall unit 1 15mm 082-000196-00
tube
18 Sampling silicone 3.0*1.0 Overall unit 1 15mm 082-000196-00
tube
19 Sampling silicone 4.0*2.0 Overall unit 1 35mm 082-000523-00
tube
20 Sampling silicone 4.0*2.0 Overall unit 1 35mm 082-000523-00
tube
21 Sampling silicone 4.0*2.0 Overall unit 1 100mm 082-000523-00
tube
22 Sampling silicone 4.0*2.0 Overall unit 1 100mm 082-000523-00
tube
23 Sampling silicone 4.0*2.0 Overall unit 1 150mm 082-000523-00
tube

9-2
Circuit and Gas Circuit Connection

24 Sampling silicone 4.0*2.0 Overall unit 1 150mm 082-000523-00


tube
25 PU tube 6.0*4.0 Overall unit 1 160mm 082-000046-00
26 PU tube 6.0*4.0 Overall unit 1 160mm 082-000046-00

Circuit Connection

Circuit connection diagram

#1 #2
#25
S18
S1 S2
#24
#3 S17
S3 #20
#23
B12 S16
S4 B2 #6
#19
#4
B1 #22
S15
S4
#21
B13
#5
S5
S14
B3 #18
S13
B8
#17
B4 #7 S12
#16
S6 S11
#9
S10
#10
B5 S9
#8
B7
#11
B6 #15
B10 B11

#14
#12
B9
S7
#13
S8

Description:
Ø The hollow arrow indicates the connection through the board-to-board connector, and the solid arrow
indicates the connection through the wire.
Ø “Bxx” indicates the self-made board card, and “Sxx” indicates the purchased materials.
Ø “#Xx” indicates the wire.

Circuit connection list

Serial No. Description Material code

9-3
Circuit and Gas Circuit Connection

#1 AC power cord inside the V3 machine 009-002190-00


#2 Power cord of the V3 power panel 009-002105-01
#3 V3 DC power cord 009-002041-02
#4 Communication line of the V3 battery board 009-002006-01
#5 V3 fan cable 009-002106-00
#6 Power cord of the V3 monitoring bottom board 009-002011-02
#7 Communication line of the V3 indicator board 009-002017-01
#8 Communication line of the V3 display 009-002014-02
#9 V3 capacitive screen cable 009-002007-01
#10 V3 shuttle cable 009-002009-01
#11 V3 alarm indicator cable 009-002003-01
Communication line of V3 mainstream CO2 009-002018-01
#12
Communication line of V3 sidestream CO2 009-002013-02
#13 V3 horn cable 009-002194-00
#14 Communication line of the V3 negative pressure sensor 009-002010-02
#15 Communication line of the V3 SpO2 bottom board 009-002193-00
#16 V3 atomization valve cable 009-002107-00
#17 V3 safety valve cable 009-002108-00
#18 V3 turbine external temperature sensor cable 009-002192-00
#19 Communication line of the V3 sensor board_1 009-002004-01
#20 Communication line of the V3 sensor board_2 009-002005-01
#21 V3 zero calibration valve cable 1 009-002109-00
#22 V3 O2 battery cable 009-002029-01
#23 Communication line of the V3 heater flow sensor 009-002195-00
#24 Communication line of the V3 heater flow sensor 009-002195-00
#25 V3 safety valve cable 009-002108-00
S1 AC filter socket 008-001113-00
S2 AC-DC switching power supply module 0691-013-000011-00
S3 Female external DC socket 008-001183-00
S4 V3 smart lithium battery 022-000203-00
S5 V3 cooling fan 024-000158-00
S6 12.1 fully fit display screen
MASIMO sidestream CO2 built-in module 051-001157-00
S7
C30 12-pin CO2 socket 008-000240-01
S8 Horn 020-000012-00
S9 Inspiratory valve
S10 Expiratory valve

9-4
Circuit and Gas Circuit Connection

S11 Atomization solenoid valve


S12 O2 proportional valve
S13 V3 turbine external temperature sensor cable 009-002192-00
S14 Turbofan
S15 O2 battery
S16 Heater flow sensor
S17 TSI heater flow sensor
S18 Safety valve
B1 V3 battery adapter board PCBA 051-001569-00
B2 V3 DC power board PCBA 051-001546-00
B3 IMX7 core board PCBA 051-001380-02
B4 V3 indicator board PCBA 051-001567-00
B5 V3 shuttle board PCBA 051-001566-00
B6 V3 alarm indicator board PCBA 051-001565-00
B7 V3 key board PCBA 051-001563-00
B8 V3 monitoring bottom board PCBA 051-001547-00
B9 V3 negative pressure sensor board PCBA 051-001568-00
V3 MASIMO SpO2 bottom board PCBA
B10 V3 NELL SpO2 bottom board PCBA
V3 Comen SpO2 bottom board PCBA
B11 V3 SpO2 side panel PCBA
B12 V3 sensor board PCBA
B13 V3 zero calibration valve board PCBA

9-5
Chapter 10 Parts

O2 Inlet Components (NIST)

Explosive view

List of parts

Serial No. Material code Description Quantity


1 041-00000942-00 O2 end inlet connector 1
2 082-00000120-00 High-pressure O2 inlet filter block 1
3 049-001784-00 O-ring 1
4 082-000355-00 Atomization switch valve 1
5 049-000098-00 O-ring 1
6 041-00000944-00 Atomization air-resistor 1

10-1
Parts

7 041-00000938-00 Parker proportional valve seat component 1


8 041-00000943-00 Air-capacitor 1
9 049-00000285-00 O-ring 1
10 082-000498-00 Connector 1
11 082-000461-00 Pressure reducing valve 1
12 082-001099-00 Connector female 1
13 041-004088-03 Ventilator’s low-pressure O2 connector seat 1
14 082-000889-00 Proportional valve 1
15 042-002786-03 Ventilator’s high-pressure O2 block fixing bracket 1
16 082-000251-00 Quick-plug connector 1
17 042-00000253-00 Fixed sheet metal for V3 flow sensor 1
18 082-000810-00 O2 mass flow sensor 1

O2 Inlet Components (DISS)

Explosive view

List of parts

Serial No. Material code Description Quantity


1 041-00005391-00 O2 end inlet connector 1

10-2
Parts

2 082-000035-00 Filter 1
3 049-001784-00 O-ring 1
4 041-003899-00 Filter fixing ring 1
5 049-000098-00 O-ring 1
6 041-00000944-00 Atomization air-resistor 1
7 041-00000938-00 Parker proportional valve seat component 1
8 041-00000943-00 Air-capacitor 1
9 049-00000285-00 O-ring 1
10 082-000498-00 Connector 1
11 082-000461-00 Pressure reducing valve 1
12 082-001099-00 Connector female 1
13 041-004088-03 Ventilator’s low-pressure O2 connector seat 1
14 082-000889-00 Proportional valve 1
15 042-002786-03 Ventilator’s high-pressure O2 block fixing bracket 1
16 082-000251-00 Quick-plug connector 1
17 042-00000253-00 Fixed sheet metal for V3 flow sensor 1
18 082-000810-00 O2 mass flow sensor 1

Expiratory Valve Components

Explosive view

1
2

List of parts

Serial No. Material code Description Quantity


1 115-007019-00 Expiratory valve seat component 1
2 115-007020-00 Quick release component for expiratory valves 1

10-3
Parts

Inspiratory Valve Components

Explosive view

1
2

List of parts

Serial No. Material code Description Quantity


1 115-007017-00 Inspiratory valve seat component 1
2 115-007018-00 Quick release component for inspiratory valves 1

10-4
Parts

Inspiratory Valve Seat Components

Explosive view

List of parts

Serial No. Material code Description Quantity


1 042-002783-00 Ventilator’s inspiration port fixing bracket 1
2 024-00000001-00 Electromagnet 1
3 043-004874-00 Inspiratory valve mounting seat 1

10-5
Parts

Quick Release Part for Inspiratory Valves

Explosive view

List of parts

Serial No. Material code Description Quantity


1 043-004873-00 Inspiratory valve knob 1
2 043-004875-00 Inspiratory valve body 1
3 043-005802-00 Safety valve port 1
4 043-005821-00 Inspiratory valve body plug 1
5 043-004878-00 Check valve fixing ring 1
6 049-001704-00 Safety valve diaphragm 1
7 041-005410-00 Safety valve diaphragm gasket 1
8 049-001762-00 O-ring 3
9 033-000407-00 Inspiratory valve sealing valve spring 1
10 049-001702-00 Inspiratory unidirectional diaphragm 1

10-6
Parts

11 049-001763-00 O-ring 1
12 049-001758-00 O-ring 1

Quick Release Components for Expiratory Valves

Explosive view

List of parts

Serial No. Material code Description Quantity


1 043-004879-00 Expiratory valve knob 1
2 043-004569-00 Expiratory valve body 1
3 049-001388-00 Expiratory valve pressure transfer silica gel 1
4 115-00000615-00 Expiratory flow sensor component 1
5 049-001523-00 Encapsulated diaphragm of the expiratory valve 1
6 049-001701-00 Expiratory unidirectional diaphragm 1

10-7
Parts

Turbine Box Components

Explosive view

1
1

List of parts

Serial No. Material code Description Quantity


1 115-007014-00 Turbine box component 1
2 115-007015-00 Filter box component 1

10-8
Parts

Low-pressure Proportional Control Valve Components

Explosive view

List of parts

Serial No. Material code Description Quantity


1 049-001375-00 O-ring 1
2 043-004557-00 Low-pressure proportional control valve body 1
3 049-001786-00 Low-pressure valve diaphragm 1
4 041-005407-00 Low-pressure valve ball head component 1
5 033-00000065-00 1 1
6 049-001757-00 O-ring 1
7 049-001763-00 O-ring 1
8 041-003513-00 Low-pressure valve seat 1
9 024-000122-00 Voice coil motor 1
10 049-001759-00 Encapsulated filter mesh 1

10-9
Parts

Trolley Components

Explosive view

List of parts

Serial No. Material code Description Quantity


1 / Humidifier fixing component 1
2 / Platform component 1
3 / Tubing set support arm component 1
4 / Fixed column component 1
5 / Cylinder fixing component 1
6 / Chassis component 1

10-10
Parts

Trolley Handle Components

Explosive view

List of parts

Serial No. Material code Description Quantity


1 044-000529-00 Push handle 1
2 044-000531-00 Side armrest 2
3 044-000532-00 Platform side lever 4
4 041-004104-00 Armrest 2
5 044-000528-00 Platform bracket 1

10-11
Parts

Trolley Support Platform Components

Explosive view

List of parts

Serial No. Material code Description Quantity


1 / Side armrest component 2
2 044-000530-00 Armrest 2
3 / Platform component 1
4 / Pulley mechanism component 1
5 044-000528-00 Platform bracket 1
6 / Quick release handle component 1
7 / Push handle component 1

10-12
Parts

Trolley Chassis Components

Explosive view

List of parts

Serial No. Material code Description Quantity


1 042-002805-00 Base bracket 1
2 042-002804-00 O2 cylinder tray 1
3 / EVA 1
4 044-000527-00 Trolley base 1
5 034-000066-00 4-Inch screw rod medical double wheels with brake 4

10-13
Parts

Trolley Gas Cylinder Fixing Components

Explosive view

List of parts

Serial No. Material code Description Quantity


1 042-003385-00 O2 cylinder fixing bracket 1
2 / 7L O2 cylinder 2
3 / O2 cylinder strap 2
4 042-002805-00 Base bracket 1
5 / EVA 1
6 042-002804-00 O2 cylinder tray 1

10-14
Appendix I Preventive Maintenance Report of
Comen V3/V3A Ventilator

Hospital name
Department name
Maintenance engineer
Maintenance date (DD/MM/YYYY)

I.1 Machine state validation before maintenance

Ventilator serial Total running time of the system (hours)


number (User -> Syst. Info -> Maintain)
Software version Main control board
(Service -> Setup -> software
Version) Protection module
Control module

Inspection item Operation Results


Insert the USB flash drive into the USB interface,
Data export Power on and export data from the User - Data □ Completed □ Uncompleted
Transfer - Export Data menu
Set the standby state
□ Pass □ Fail
System self-test Select the system self-test and follow the prompts
(Leakage ml/min)
to complete
Connect to the analog lung
Ventilation status Use V-A/C and P-A/C to simulate ventilation □ Pass □ Fail
detection respectively to confirm that the machine can (Alarm )
ventilate normally without technical alarm
Check whether the machine and accessories are
Appearance testing obviously damaged, if any, please attach pictures □ Pass □ Fail
for recording

I.2 Preventive maintenance

10-1
Preventive Maintenance Report of Comen V3/V3A Ventilator

Serial No. Inspection item Operation Results


Maintenance package replacement (Section 6.2.1)
Replace according to
1 Expiratory valve diaphragm □Y□N
the manual steps
Replace according to
2 HEPA filter □Y□N
the manual steps
Replace according to
3 Dust screen at the air inlet □Y□N
the manual steps
Replace according to
4 Fan dust screen □Y□N
the manual steps
Replace according to
5 2 pressure sensor filters PTFE 13mm □Y□N
the manual steps
Calibration (Section 6.3)
Pressure and flow zero calibration Follow the steps to
6 □Y□N
(manufacturer) calibrate successfully
Follow the steps to
7 Flow calibration (manufacturer) □Y□N
calibrate successfully
Follow the steps to
8 Pressure calibration (manufacturer) □Y□N
calibrate successfully
Follow the steps to
O2 concentration calibration calibrate successfully □Y□N
9
(manufacturer) and record the AD (21% 100% )
value
Air-oxygen calibration Follow the steps to
10 □Y□N
(manufacturer) calibrate successfully
Expiratory valve calibration Follow the steps to
11 □Y□N
(manufacturer) calibrate successfully
Follow the steps to
12 Sidestream CO2 calibration (user) □Y□N
calibrate successfully

I.3 Test after maintenance


System self-test (Section 6.2.1)
Serial No. Inspection item Results Remark
1 Turbine test □ Pass □ Fail
2 O2 flow sensor test □ Pass □ Fail
3 Inspiratory flow sensor test □ Pass □ Fail
4 Expiratory flow sensor test □ Pass □ Fail
5 Pressure sensor test □ Pass □ Fail
6 Expiratory valve test □ Pass □ Fail

10-2
Preventive Maintenance Report of Comen V3/V3A Ventilator

7 Safety valve test □ Pass □ Fail


8 Leakage (mL/min) <300ml/min is acceptable
9 Compliance (mL/cmH2O)
10 Tubing set resistance (cmH2O/L/s)
11 O2 sensor test □ Pass □ Fail

Mechanical ventilation status detection (Section 6.2.2)


Ventilation
Combination Parameter settings Clinical monitoring Results
mode
1 Tidal volume 150 ml Inspiratory tidal volume □Pass □Fail
2 Tidal volume 300 ml Inspiratory tidal volume □Pass □Fail
V-A/C
3 Tidal volume 600 ml Inspiratory tidal volume □Pass □Fail
4 Tidal volume 900 ml Inspiratory tidal volume □Pass □Fail
△ Inspiratory
10 cmH2O Peak pressure □Pass □Fail
pressure
5
End-tidal positive End-tidal positive
OFF □Pass □Fail
pressure pressure
△ Inspiratory
15 cmH2O Peak pressure □Pass □Fail
pressure
P-A/C 6
End-tidal positive End-tidal positive
5 cmH2O □Pass □Fail
pressure pressure
△ Inspiratory
20 cmH2O Peak pressure □Pass □Fail
pressure
7
End-tidal positive End-tidal positive
8 cmH2O □Pass □Fail
pressure pressure

Sensor zero point correctness detection (Section 6.2.3)


Serial
Sensor name AD value Actual value Scope Results
No.
1 Total branch flow sensor -0.5~1L/min □Pass □Fail
2 O2 flow sensor -0.5~1L/min □Pass □Fail
3 Expiratory flow sensor 365~910 □Pass □Fail
4 Inspiratory pressure sensor 967~1875 □Pass □Fail
5 Expiratory pressure sensor 967~1875 □Pass □Fail

Flow sensor measurement accuracy detection (Section 6.2.4)


Air branch
Serial No. Large-diameter inspiratory Actual value of total Actual value of Results

10-3
Preventive Maintenance Report of Comen V3/V3A Ventilator

valve branch flow sensor expiratory flow sensor


(L/min)
1 3±0.5 □Pass □Fail
2 10±1 □Pass □Fail
3 20±1 □Pass □Fail
4 30±2 □Pass □Fail
5 60±3 □Pass □Fail

High-pressure O2 branch
O2 proportional valve Actual value of O2 flow
Serial No. / Results
(L/min) sensor
1 3±0.5 / □Pass □Fail
2 10±1 / □Pass □Fail
3 20±1 / □Pass □Fail
4 30±2 / □Pass □Fail
5 60±3 / □Pass □Fail

Pressure sensor measurement accuracy detection (Section 6.2.5)


Actual value of Actual value of the Actual value of the
Serial Expiratory valve
the calibration inspiratory pressure expiratory pressure Reults
No. (cmH2O)
device sensor sensor
1 5±1 □Pass □Fail
2 20±1 □Pass □Fail
3 50±1 □Pass □Fail
4 70±2 □Pass □Fail

10-4
Preventive Maintenance Report of Comen V3/V3A Ventilator

Feedback from the hospital

Engineer signature:

Signature of the head of the department: Date:

Hospital seal:

Note: Please upload the content of this report as an attachment to the CRM proactive maintenance work
order to check the maintenance records.

10-5

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