Copyright

Edition:B00
Date: 12/2020
Shenzhen Comen Medical Instruments Co., Ltd.

Product Information
Product Name: High Flow Heated Respiratory Humidifier

Models: NF1,NF2,NF3,NF5

Software Version: V1

Address: Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of

Building 2, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming

District, Shenzhen, Guangdong, 518106, P.R. China

Statement
Shenzhen Comen Medical Instruments Co., Ltd. (hereinafter referred to as Comen or Comen
Company) owns the copyright of this User’s Manual (non-public publication), and has a right
to process it as restricted materials. This User’s Manual may serve as references for operation,
maintenance and repair of Comen products. Anybody else has no right to show to people the
contents of the User’s Manual.
The User’s Manual contains exclusive data under the protection of law of copyright. All
rights reserved. Any individual or organization must not reproduce, amend or translate any
part of the User’s Manual without prior written approval from Comen Company.
Edition number of the User’s Manual is subject to upgrading without prior notice due to any
changes in software, technical specification or other causes.
The User’s Manual is only applicable to the NF1, NF2, NF3, and NF5 High Flow Heated
Respiratory Humidifiers manufactured by the Comen Company.

Warranty
Comen Company will be responsible for the safety, reliability and performance of its
products on the conditions that the following conditions are complied:
 The products are operated as per the User’s Manual;
 The products are installed, maintained and upgraded by personnel approved or
authorized by Comen company.

III
  Storage environment, working environment and electrical environment of the products
conform to the product specifications;
 The product serial number label or indication of manufacture is clear and legible such
that Comen may identity that the products are authentically manufactured by Comen
Company;
 The damages are not caused by human factors (such as dropout by accident, deliberately
sabotage etc.);

Comen Company will provide free warranty services for all products failures satisfying the

Comen's warranty conditions. Comen may charge a service fees for any services not within

the product's warrenty. User has to bear all transportation costs (including customer's duties)

for sending the products to Comen.

Return Purchase
If return purchase is really necessary, please follow the steps given below:
Acquiring the right of return: Contact the After-sale Service Department of Comen company
and inform it of the serial number of Comen instrument. The serial number can be found on
the data plate. If serial number of an instrument is not clear and legible, return purchase may
not be accepted. Furthermore, please indicate the serial number and date of production of the
instrument, and describe briefly the causes of return purchase.

After-sales Service
Provider: After-sales Service Department, Shenzhen Comen Medical Instruments Co., Ltd.
Address:Floor 10 of Building 1A , FIYTA Timepiece Building, Nanhuan Avenue, Matian Su
b-district, Guangming District, Shenzhen, 518106, Guangdong, China
Tel: +86 755 26431236
Fax: +86 755 26431232
Service hotline: 400-700-9488

ZIP: 518106

IV
 Table of Contents

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

1.1 SAFETY WARNING............................................................................................................................ 1

1.2 CONTRAINDICATIONS........................................................................................................................ 7

1.3 SIDE-EFFECT.................................................................................................................................... 7

1.4 SYMBOLS USED IN THIS DEVICE OR USER MANUAL............................................................................... 7

CHAPTER 2 WORKING PRINCIPLE.........................................................................................................1

2.1 PRINCIPLE OF CIRCUITS................................................................................................................1

2.1.1 Block Diagram of the Hardware System............................................................................ 1

2.1.2 Schematic Circuit Diagram.................................................................................................2

2.1.3 Functional Description of the Board Card.......................................................................... 2

2.1.4 Wiring Diagram of the Electrical System........................................................................... 7

2.2 GAS CIRCUIT PRINCIPLE.............................................................................................................. 8

2.2.1 Gas Circuit Diagram........................................................................................................... 8

2.2.2 List of Parts.........................................................................................................................8

CHAPTER 3 INSPECTION AND TEST.......................................................................................................1

3.1 SYSTEM INSPECTION.....................................................................................................................1

3.2 POWER FAILURE ALARM TEST (EXTERNAL POWER SUPPLY AND BUZZER)................................. 2

3.3 O2 GAS SUPPLY PIPELINE TEST................................................................................................... 2

3.4 VENTILATION FUNCTION TEST......................................................................................................3

3.4.1 O2 Concentration Test........................................................................................................3

3.4.2 Flow Test.............................................................................................................................5

3.4.3 Temperature Test............................................................................................................... 5

3.5 ALARM TEST................................................................................................................................ 6

3.5.1 Preparation Before Alarm Test...........................................................................................7

3.5.2 Alarm Function Test............................................................................................................7

3.5.3 Alarm Test During Battery Use...........................................................................................7

V
 3.5.4 Power-off Alarm Test..........................................................................................................7

3.5.5 Low O2 Source Pressure Alarm Test................................................................................... 8

3.5.6 Too High O2 Concentration Alarm Test.............................................................................. 8

3.5.7 Too Low O2 Concentration Alarm Test............................................................................... 8

3.5.8 Too High SpO2 Alarm Test.................................................................................................. 8

3.5.9 Too Low SpO2 Alarm Test...................................................................................................8

3.5.10 Too High PR Alarm Test...................................................................................................... 9

3.5.11 Too Low PR Alarm Test....................................................................................................... 9

3.6 ELECTRICAL SAFETY TEST........................................................................................................... 9

3.6.1 Electrical Safety Inspection Test......................................................................................... 9

3.6.2 Electrical Safety Inspection Test....................................................................................... 10

CHAPTER 4 CALIBRATION..................................................................................................................... 1

4.1 CALIBRATION AND ZERO CALIBRATION OF THE GAS SOURCE PRESSURE SENSOR.....................1

4.1.1 Pressure Zero Calibration................................................................................................... 1

4.1.2 Pressure Calibration........................................................................................................... 2

4.2 TURBINE CALIBRATION................................................................................................................3

4.3 O2 FLOW CALIBRATION...............................................................................................................4

4.4 O2 CALIBRATION......................................................................................................................... 6

4.5 TOUCH SCREEN CALIBRATION..................................................................................................... 7

CHAPTER 5 TROUBLESHOOTING.......................................................................................................... 1

5.1 OVERVIEW.................................................................................................................................... 1

5.2 TECHNICAL ALARMS AND DIAGNOSIS......................................................................................... 1

5.2.1 Technical Alarms of the Main Control Board..................................................................... 1

5.2.2 Technical Alarms of the Monitoring Board........................................................................ 4

5.3 HARDWARE AND ELECTRICAL SYSTEM FAILURE....................................................................... 10

CHAPTER 6 REPAIR AND DISASSEMBLY............................................................................................... 1

6.1 PREPARATION FOR DISASSEMBLY................................................................................................ 1

VI
 6.1.1 Tools................................................................................................................................... 1

6.1.2 Preparations.......................................................................................................................1

6.2 DISASSEMBLING THE HEATED RESPIRATORY HUMIDIFIER.......................................................... 2

6.2.1 Disassembling the Main Unit............................................................................................. 2

CHAPTER 7 PARTS................................................................................................................................. 1

7.1 MAIN COMPONENTS..................................................................................................................... 1

7.1.1 Overall Unit........................................................................................................................ 1

7.1.2 Chassis Assembly................................................................................................................2

7.1.3 Main Unit Assembly........................................................................................................... 3

CHAPTER 8 MAINTENANCE AND CARE................................................................................................ 1

8.1 MAINTENANCE PRINCIPLE..................................................................................................................1

8.2 MAINTENANCE SCHEDULE................................................................................................................. 2

8.3 BATTERY MAINTENANCE..............................................................................................................2

8.4 FILTER REPLACEMENT................................................................................................................. 4

8.5 FUSE REPLACEMENT.................................................................................................................... 4

8.6 POLLUTION-FREE TREATMENT AND RECYCLING...................................................................................... 5

CHAPTER 9 SOFTWARE UPGRADE........................................................................................................1

9.1 SOFTWARE ITERATIVE UPGRADE.................................................................................................. 1

9.2 UPGRADE OF USB FLASH DRIVE................................................................................................. 2

9.2.1 System Software Program Upgrade...................................................................................2

9.2.2 Monitoring VCM Program Upgrade...................................................................................2

VII
 Chapter 1 Safety Information

1.1 Safety Warning

Warning
 Indicates 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
 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.

Note
 Indicates important precautions, provides instructions or explanations on how to
better use the product.

Warning
 This device is not intended to provide complete ventilation support and cannot be
used as a life support device.
 This User Manual is for reference only. The instructions in this User Manual
cannot replace the instructions of the healthcare professional.
 Read and understand this User Manual thoroughly before using the device.
 If the patient experiences any discomfort while using the device, contact the
healthcare professional immediately.
 To use normally, the mains plug on power supply cord should be plug into the

Chapter 1-1
 multiple socket outlet vertically.
 Please monitor the patient while using the device. If the power supply is
interrupted, the device will stop working.
 In case of battery power supply, the heating function of the High Flow Heated
Respiratory Humidifier is not available.
 Regularly inspect the flexible wires, cables, and power supply units for damage or
signs of wear. If there is any damage, stop using the device and replace the
damaged parts.
 Nasal delivery of respiratory gas produces positive airway pressure (PAP)
depending on the airflow. Please consider the possible adverse reactions by patients
to positive airway pressure (PAP).
 Do not use the device when the room temperature exceeds 30 ºC (86 ºF) or is below
10 ºC (50 ºF). Under such conditions, the device may automatically shut down. The
humidity of the output gas is affected when the room temperature is below 18 ºC
(64 ºF) or above 28 ºC (82 ºF).
 Do not use the device under direct sunlight or near a heating unit, as these
conditions can cause the temperature of the air coming out of the device to
increase.
 When using oxygen-enriched gas, keep the device as far away as possible from any
fire source.
 Please do not use it in a hyperbaric oxygen chamber.
 When using this device, please prepare simple respirators or other machines that
can temporarily replace this device to ensure that in the event of a sudden failure of
this device, the normal treatment of the patient is not affected and to prevent any
injury to the patient.
 This device can only be used using the treatment modes, humidification tanks, and
heated RESP tubing sets specified in this User Manual.
 This product must be used in accordance with the requirements of Medical
electrical equipment – General requirements for safety.
 Our company ensure the compatibility of the humidifier and all of the parts and
accessories used to connect to the patient or other equipment before use.
 To avoid burns:
 This device should only be used with the interfaces, humidification tanks, and
RESP tubing sets specified in this User Manual.

Chapter 1-2
 Replace the RESP tubing set or RESP interface after using for a certain period of
time, as it may cause serious injury, including infection.
 Before using this device to supplement O2, please read all warnings in this User
Manual carefully.
 Do not use this device under any of the following circumstances:
 The heated RESP tubing set is damaged, perforated, cracked, or twisted.
 The device is not working properly.
 The screws on the device casing are loose or have fallen off.
 Do not block the device and RESP tubing set airflow.
 The device should be placed and used in a well-ventilated environment.
 Never block the air inlet of the device or place it on a soft surface such as a bed or
sofa, as it may lead to blocking of the filter port. Protect the air inlet from lint, hair,
and dust blockage.
 To avoid electric shock:
 Do not store or use this device in a place where it may fall into water, or water may
drop on it. If water has entered the enclosure, unplug the power cord, and stop
using the device.
 Do not use this device under any of the following circumstances:
 The device has been dropped or damaged.
 The power cord or plug is damaged.
 The device fell into the water.
 If it is not necessary, please avoid unplugging the power cord from the back of the
device. If you must unplug the power cord, grasp the plug when unplugging. Avoid
pulling the power cord directly.
 Unplug the device before cleaning it.
 Unless otherwise specified in this User Manual, please send this device to an
authorized repair center for inspection and repair.
 Ways to avoid airway obstruction or inhalation of foreign substances:
 Make sure that the device is equipped with an air filter when in use.
 Never drop or insert anything into any opening or tubing set.
 This device is not suitable for use in environments where combustible anesthetic is
mixed with air, oxygen, or nitrous oxide.
 Before usage by a patient, please perform the alarm system function check as
described in the alarm section of this User Manual, to ensure that the audible

Chapter 1-3
 alarm can be heard normally.
 Please check whether the alarm limit setting is reasonable before performing
ventilation. Set alarm limits to extreme values could render the alarm system
useless.
 Set the alarm volume and alarm limit according to the patient’s actual situation.
You cannot rely solely on the audible alarm system to monitor the patient.
Adjusting the alarm sound to a low volume may put the patient at risk. Pay close
attention to the actual clinical situation of the patient.
 The parts of this product that come into contact with patients do not contain
natural latex materials and phthalates.
 All personnel should be aware that there is a risk of infection when removing or
cleaning certain parts of the High Flow Heated Respiratory Humidifier.
 In accordance with regulations, O2 concentration monitoring is required when the
device is used for patients. If the device you are using is not equipped with this
function or the function is disabled, please monitor O2 concentration at the point
delivery to patient with a monitor that meets the requirements of YY 0601
(equivalent to ISO 80601-2-55).
 The operating environment of the device should conform to the environmental
requirements specified in this User Manual. An operating environment beyond the
specified scope may affect the accuracy of the device and damage the components
and wiring.
 To avoid personal injury or device damage, please ensure that the High Flow
Heated Respiratory Humidifier is securely attached to a trolley or placed on a safe
and stable platform.
 All analog and digital devices connected with the system must be products certified
as per specified standards (such as GB 4943(equivalent to IEC 60950-1) Data
processing equipment standard and GB 9706.1(equivalent to IEC 60601-1) Medical
electrical equipment standard). Moreover, all configurations should adhere to the
valid version of the GB 9706.15(equivalent to IEC 60601-1-1) system standard.
Personnel responsible for connecting additional devices to the input/output signal
ports should configure the medical system and are responsible to ensure the system
complies with the GB 9706.15(equivalent to IEC 60601-1-1) standard.
 The vapor content in medical oxygen should not exceed 5.63g/m3
(water/non-condensing gas).

Chapter 1-4
 If there is any doubt about the integrity of the external protective conductors
during installation or wiring, the device should be operated using the internal
battery.
 The alarm setting can be saved after shut down is initiated, for up to 30 seconds,
and the setting before the shutdown can be maintained.
 The O2 concentration delivered to the patient is affected by the flow, O2
concentration set value, RESP interface, or obstruction of the airflow channel.
 The performance of the High Flow Heated Respiratory Humidifier may be
adversely affected when exposed to electrocautery, electrosurgery, defibrillation,
X-rays (gamma rays), infrared radiation, transient electromagnetic fields,
including magnetic resonance imaging (MRI) and radio interference.
 The recovery time of other parameters after defibrillation is not more than 10s.
 Do not adjust, repair, open, disassemble, or modify the device or accessories. Injury
to personnel or equipment damage could occur. Return the device for servicing if
necessary.
 The device is not suitable for use with Oxygen 93.
 No maintenance that is required to beperformed by the operator, and only
authorized and trained technicians are allowed to repair the High Flow Heated
Respiratory Humidifier.
 To prevent disconnection of the tubing or tubing system during use, especially
during transportable use,only tubes in compliance with ISO 5367 or ISO
80601-2-74 should be used.
 Hazard would exist if different alarm presets are used for the same or similar
equipment in any single area, e.g. an intensive care unit or cardiac operating
theatre.
 when technical alarm condition occur on the monitoring parameter module(e.g.
SpO2 and O2) , the measured value will displayed as "--" . It is suggested that the
operator take more attention to the patient's status and aware the alarm
conditions.
 There are no known adverse effects on the oxygen sensor.
 When the device is connected to the patient, no maintenance tasks can be
performed. Such tasks must be performed without the patient using the equipment.
 The same or similar equipment used in corresponding independent areas may be
potentially dangerous if different alarm presets are used. Before use, please read

Chapter 1-5
 the manual to confirm the alarm preset.
 Do not place the power plug used to disconnect the device from supply mains in a p
osition not easily accessible by the operator.
 The maximum operating pressure of the hose is 1.0MPa@21℃. Before use, check t
hat the air source pressure meets the requirements of the hose.
 The connecting piece on the hose adopts a standard gas terminal joint, which has t
he characteristic properties of gas. Different types of gases and gases of the same ty
pe and different pressures cannot be interchanged.
 Long-term contact with acidic, alkaline or ultraviolet light will accelerate the aging
of the hose.
 Do not add any attachments or accessories to the humidifier that are not listed in
the instruction for use of the humidifier or accessory or the humidifier might not
function correctly affecting the quality of the therapy or injuring the patient.
 Do not use the humidifier at an altitude above 3000m or outside a temperature of
18 ℃- 28 ℃. Using the humidifier outside of this temperature range or above this
altitude can affect the quality of the therapy or injure the patient.
 For patients who need to increase oxygen concentration for treatment, SpO2 monit
oring equipment should be used to monitor the patient's SpO2, otherwise the patie
nt's deterioration may not be effectively identified.

Caution
 To avoid device damage and ensure patient safety, please only use the accessories
specified in this User Manual.
 Before the device is powered on, please confirm whether the power supply meets
the requirements specified on the device nameplate label or the supply voltage and
frequency specified in the User Manual.
 When the device and accessories are about to reach their end of service life, they
must be disposed of in accordance with the relevant local laws and regulations or
the rules and regulations of the hospital.
 Recycle or properly dispose all disposable accessories, to protect the environment.
 The symbol for overheating is marked front of main unit and should not touch hot
surface near humidifier tank.

Chapter 1-6
 Note
 This device must be used by professionally trained clinical medical personnel or
technical maintenance personnel authorized by Comen.
 Please install the device in a place that is convenient for observation, operation, and
maintenance.
 This device cannot be used at home.
 This User Manual introduces the product according to the full configuration. The
specific model you purchased may not have certain configurations or functions.
 Please place the User Manual near the device for easy and quick reference.
 During normal use, the operator should remain within one meter of the device.
 Low-temperature environmental conditions may prevent the device from reaching
the target temperature set by the target flow. In this case, consider lowering the
target flow setting.

1.2Contraindications

Please don't clip oxygen saturation probe on the same position for long period.

The patients who are allergic to the rubber materials shall not use it.

1.3 Side-effect

No side-effect by the publication of the user manual.

1.4Symbols Used in this Device or User Manual

Description Symbol

Manufacturer

Date of manufacturer

Chapter 1-7
 Description Symbol
Caution. See the accompanying information
(in this User Manual)

SpO2 SpO2

Defibrillation-proof Type BF applied part

Power supply AC indicator

Alarm sound pause

Power/Standby key

USB interface
Serial No.

Network interface identification

Identification of fuse specification

Power supply specification identification

NF2/NF3/NF5 O2 gas inlet pressure and flow

rate limitation

NF1 O2 gas inlet pressure and flow rate

limitation(30 l flowmeter)

Chapter 1-8
 Description Symbol

NF1 O2 gas inlet pressure and flow rate

limitation(50 l flowmeter)

Mass of trolley including safety working load

Safe working load of hook(each) on trolley

Safe working load of basket and pole clamp of

oxygen flow meter

Safe working load of supporting form on

trolley

Maximum output power of heating pipeline

Anti-blocking indicator for air inlet

Chapter 1-9
 Description Symbol

Hot! Do not touch

Refer to the User Manual

“This way up” identification

“Fragile” identification

Stacking layer limit

“Keep dry” identification

“Do not roll” transportation and packaging

identification

“Center of gravity” identification

Comply with the requirements of electrical

and electronic machinery (WEEE/RoHS)
recycling directive for the recycling of waste
electrical and electronic machinery/restrictions
on the use of toxic substances

Environmental protection service life of

electronic products (20 years)

Waterproof rating of the High Flow Heated IPX2

Chapter 1-10
 Description Symbol
Respiratory Humidifier

Recyclable and renewable

Recovery and recycling

Temperature limit

Humidity limit

Atmospheric pressure limit

Chapter 1-11
 Chapter 2 Working Principle

2.1 Principle of Circuits

2.1.1 Block Diagram of the Hardware System

The hardware system block diagram of NF1/NF2/NF3/NF5 is shown in the figure below. The
wiring in the figure is used to illustrate the wiring relationship between hardware board cards, and
systems.

Figure 2- 1 Block diagram of the hardware system

NF1/NF2/NF3/NF5 hardware system is divided into main control system and monitoring
system. Among which:
1. Main control system: It mainly includes the main control bottom board, main control core
board, SpO2 module, LCD screen, touch screen and peripheral interfaces. The system mainly
realizes the human-computer interaction function of the instrument, and realizes data interaction

Chapter 2-1
and SpO2 monitoring with other systems.
2. Monitoring system: It mainly includes the AC/DC board, battery, battery management
board, monitoring board, gas source pressure sensor board, O2 sensor, atmospheric pressure
sensor board, flow sensor, etc. It mainly realizes pressure detection, flow control and detection, O2
concentration control and detection, temperature detection and control, etc.

2.1.2 Schematic Circuit Diagram

Figure 2- 2 Schematic circuit diagram

2.1.3 Functional Description of the Board Card

AC/DC board:
The AC/DC board mainly converts AC power supply into 24V DC power supply and supplies
it to the monitoring board.

Chapter 2-2
 Socket Pin No. Signal name Signal description Socket function
1 Neutral AC power supply AC input for the
CN1
3 Line AC power supply switching power supply
1、2 DC RTN Output return DC output for the
CN101
3、4 Vo 24V output switching power supply

Monitoring board:
It is mainly used for temperature, flow, O2 concentration control and detection, and power
supply for other components.

Socket Socket name Connection object

Power interface for Connect the switching power supply, which supplies 24V
J1
monitoring board for the monitoring board
J2 Socket for turbine Connect the turbine winding, and the monitoring board
winding supplies 24V for the turbine winding

Chapter 2-3
 Turbine Hall socket Connect the turbine Hall sensor and temperature sensor to
J3
obtain Hall signal and temperature signal
J5 Socket for monitoring Connect the main control bottom board to supply power and
board-main control board signal transmission to the main control board
J6 Battery socket for Connect the battery, which supplies power for the
monitoring board monitoring board
Socket for monitoring Connect the cable adapter board to provide power and
J7
board-cable adapter board control signals for the cable adapter board
J11 Socket for thermostat and Connect the thermostat and NTC on the heating plate
NTC
J12 Socket for gas outlet Connect the fresh gas outlet NTC
NTC
J13 Socket for ultrasonic O2 Connect the ultrasonic O2 sensor
sensor
J14 Socket for heating wire Connect the RESP tubing set
J16 AC input socket Connect the AC input
J17 AC output socket Connect the AC input of the switching power supply
J18 Mica heating socket Connect the mica heating element
J19 Socket for battery Connect the battery management board
management board
J20 Socket for battery Connect the battery management board
management board
J21 Socket for program Used for MCU program burning
burning
J23 Socket for program Used for MCU program debugging
debugging
J24 Socket for gas source Connect the gas source pressure sensor board
pressure signal input

Cable adapter board:

It mainly summarizes the signal of each device and reduces the sockets of the monitoring
board.

Chapter 2-4
Socket Socket name Connection object
J1 Socket for cable adapter board-monitoring Connect the monitoring board
board
J2 O2 flow socket Connect the O2 flow sensor
J3 Hybrid flow socket Connect the air-oxygen hybrid flow sensor
J4 Socket for O2 proportional valve Connect the proportional valve plate
J6 Socket for atmospheric pressure sensor Connect the atmospheric pressure sensor
board
J7 Horn socket Connect the alarm horn

Atmospheric pressure sensor board:

It is used for ambient temperature acquisition and turbine cavity negative pressure detection.

Socket Socket name Connection object

J1 Power communication socket Connect the cable adapter board

Proportional valve plate:

It is used for cable adapter coupling.

Socket Socket name Connection object

J1 Proportional valve adapter socket Connect the cable adapter board

Battery management board:

It is used for battery charge and discharge management and power boost management.

Chapter 2-5
Socket Socket name Connection object
J1 Socket 1 for battery management board Connect the monitoring board
J2 Socket 2 for battery management board Connect the monitoring board

Main control bottom board:

It is used to drive the liquid crystal display and process related data.

Socket Socket name Connection object

J1 LCD screen signal interface Connect the LCD screen
J2 Touch screen interface Connect the touch screen

Chapter 2-6
 J3 Socket for external interface Connect the USB-network interface board
J9 Socket for SpO2 interface Connect the SpO2 interface board
J12 Socket for monitoring board Connect the monitoring board
J13 Socket for debugging serial port For debugging the upper computer
J14 Encoder socket Connect the shuttle board

2.1.4 Wiring Diagram of the Electrical System

Chapter 2-7
2.2 Gas Circuit Principle

2.2.1 Gas Circuit Diagram

Figure 2- 3 Schematic diagram of gas circuit

2.2.2 List of Parts

Serial No. Instructions Serial No. Instructions

1 Air inlet 10 Filter
2 Filter cotton 11 Flowmeter (with needle valve)
3 O2 inlet 12 Turbine box
4 Filter 13 Flow sensor
5 Pressure sensor 14 Ultrasonic O2 concentration
6 Pressure reducing valve (250kPa) 15 Check valve
7 Proportional valve 16 Humidification tank
8 Flow sensor 17 Patient tubing set connector
9 O2 inlet
Note: The serial number 9/10/11 is the unique configuration for NF1; and the serial numbers 3-8
are unique configurations for NF2, NF3, and NF5.

Chapter 2-8
 Chapter 3 Inspection and Test

Warning

 After repairing the equipment or replacing parts, please complete all tests in this

section.

 Before performing the test, please completely reinstall the equipment and perform

necessary calibration with reference to Chapter 4 Calibration.

 The patient connection must be disconnected during maintenance.

 The equipment shall conduct regular O2 concentration and flow tests to ensure the
accuracy of O2 concentration and flow measurement.

3.1 System Inspection

Attention

 Ensure that the 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 system (including the RESP tubing set, humidification tank, nasal oxygen cannula, etc.)
is connected correctly, and the RESP tubing set is intact.
4) The gas supply system is connected correctly and the pressure is normal.
5) Ensure that the casters are not damaged or loose, and the brakes are locked. The equipment
cannot be moved after it is locked.
6) Check whether the power cord is properly connected and whether the AC power indicator is
normal.
7) Check whether the equipment can be turned on and off normally.

Chapter 3-1
3.2 Power Failure Alarm Test (External Power Supply and

Buzzer)

Attention

 The battery is optional. Before the test, determine whether it is equipped with a battery.

If there is no battery, the battery power supply does not need to be tested.

1) Connect the equipment to an AC power supply, and the AC power indicator lights up. If the
power indicator does not light up, check the fuse and power board.
2) Press the power/standby button to switch on.
3) In the power-on state, disconnect the AC power supply, the system alarm information area
will display the prompt message of [Battery in use], and the AC power indicator lights off.
4) Reconnect the power supply, the prompt message of [Battery in use] disappears, the power
indicator lights up, the battery indicator stops flashing and stays on for 5 minutes.
5) Remove the internal battery of the machine and disconnect the AC power supply at the same
time. The equipment will shut down. The buzzer will start timing. If it reaches 120S or more,
the buzzer is considered to be no problem. Otherwise, the buzzer is considered invalid. Please
replace the main control bottom board.

3.3 O2 Gas Supply Pipeline Test

Attention

 Only NF2, NF3, and NF5 models can perform the gas supply pipeline test.

 NF1 adopts low-pressure oxygen input, which is verified by the O2 concentration too

low alarm test. For the O2 gas supply alarm test, see Section “3.5.6”.

1) Connect to O2 pipeline gas source.

2) Connect the RESP tubing set, humidification tank and nasal oxygen cannula.
3) Press the power/standby button to switch on.
4) In standby mode, select the adult mode, set the O2 concentration to 40%, and then select
[Start Ventilation] to enter the ventilation state.
5) Ensure that the equipment can ventilate properly.
6) Cut off the O2 pipeline gas supply.
7) As the O2 pressure decreases, a high-level alarm of [O2 source pressure is low] will be

Chapter 3-2
 triggered.

3.4 Ventilation Function Test

3.4.1 O2 Concentration Test

1) Setup environment:
Model NF1: Connect the O2 source to the O2 flowmeter, output the flow of the O2
flowmeter to the low-pressure O2 inlet of the heated respiratory humidifier, connect the
O2 concentration test equipment to the fresh gas outlet of the heated respiratory
humidifier, and the rear end of the O2 concentration test equipment is empty. As shown
in the figure:

Model NF2/NF3/NF5: Connect the O2 source to the high-pressure O2 interface of the

heated respiratory humidifier, connect the O2 concentration test equipment to the fresh
gas outlet of the heated respiratory humidifier, and the rear end of the O2 concentration
test equipment is empty. As shown in the figure:

2) Machine operation:
Model NF1: Select the adult mode, set the flow to 60 l/min, select Start Ventilation, and
adjust the flow of the O2 flowmeter to 5 l/min, 30 l/min, and 50 l/min in turn. The
measured value of O2 concentration test equipment is compared with the monitoring
value of heated respiratory humidifier, as shown in the figure:

Chapter 3-3
 Model NF2/NF3/NF5: Select the adult mode, set the flow to 30 l/min, select Start
Ventilation, and adjust the O2 concentration value to 30%, 50%, 90%, and 100% in turn.
The measured value of O2 concentration test equipment is compared with the monitoring
value of heated respiratory humidifier. As shown in the figure:

3) Determine whether the measurement data meets the following accuracy requirements:
 Measurement accuracy: Within the range of 25 vol.%~95 vol.%: ±3 vol.% of the
actual reading; other ranges are not defined
 Control accuracy: ±3vol.% of the set value.

Attention

 NF1 O2 flowmeter can be equipped with 30 l/min and 50 l/min. Different flow ranges

can be tested according to different flowmeters.

 The O2 concentration test is recommended to be performed once a year.

 The flow of the NF1 model is 60 l/min, the O2 flowmeter is adjusted to 5 l/min, 30 l/min,

and 50 l/min in turn, the output O2 concentration is 28%, 60%, and 87% respectively,

and the error of the control value of the output O2 concentration is within ±5%.

Chapter 3-4
3.4.2 Flow Test

1) Connect the O2 source to the heated respiratory humidifier, connect the flow test
equipment to the fresh gas outlet of the heated respiratory humidifier, and the rear end of
the flow test equipment is empty, as shown in the figure:

2) Machine operation: Select Start Ventilation, set the O2 concentration to 21%, adjust the
flow value to 2, 30, 60 and 80 in turn, and adjust the gas compensation mode of the flow
test equipment to “STP” mode. After the flow output is stable, the measured value of
flow test equipment is compared with the monitoring value of heated respiratory
humidifier. As shown in the figure:

3) Determine whether the measurement data meets the following accuracy requirements:
 Measurement accuracy: ±1L/Min or ±10% of the actual reading, whichever is
greater.
 Control accuracy: ±1L/Min or ±10% of the set value, whichever is greater.

Attention

 NF1 only tests the upper limit to 60 l/min.

3.4.3 Temperature Test

1) Setup environment: At 10cm above the RESP tubing set connection port, the RESP
tubing set is punched to place the TEMP probe of the temperature test equipment to

Chapter 3-5
 monitor the dew point temperature (i.e., the temperature set at the machine interface),
and the rear end of the RESP tubing set is empty. As shown in the figure:

2) Machine operation: Select Start Ventilation, and adjust the temperature values to 31°C,
34°C and 37°C in turn. After the temperature output is stable, the measured value of
temperature test equipment is compared with the set value of prototype. As shown in the
figure:

3.5 Alarm Test

Attention

 The SpO2 module is an optional accessory. If it is not equipped, SpO2-related tests are

not required.

 The battery is optional. If it is not equipped, battery-related tests are not required.

 The NF1 model is a low-pressure O2 supply, and does not require an alarm test for low

O2 source pressure.

Chapter 3-6
3.5.1 Preparation Before Alarm Test

1) Connect the RESP tubing set, humidification tank and nasal oxygen cannula.
2) Start the equipment and set the [Patient Type] to [Adult] in standby mode.
3) Set the control options of the equipment as follows (standard operating state):
 O2 concentration: 21%
 Flow: 30 l/min
 Temperature: 37°C
Remark: In the absence of a special statement, the operating state mentioned in this chapter is the
standard operating state.
4) Set to exit the standby state and enter the ventilation operating state.
5) Ensure that the equipment monitoring parameter data is displayed normally.

3.5.2 Alarm Function Test

1) Connect the equipment to AC power supply, and press the power/standby button to switch on.
2) Verify that the red-yellow alarm indicator lights are displayed alternately when the system is
started, and the alarm horn is sounded at the same time;

3.5.3 Alarm Test During Battery Use

1) Connect the equipment to AC power supply, and press the power/standby button to switch on.
2) After the system starts, disconnect the AC power supply.
3) Verify that the [Battery in use] alarm is activated and the equipment is powered by the
battery.
4) Reconnect the AC power supply.
5) Verify that the alarm is automatically reset and the equipment is powered by AC power
supply.

3.5.4 Power-off Alarm Test

1) Connect the AC power supply, and press the power/standby button to switch on.
2) After the system starts, disconnect the AC power supply after the battery is fully charged.
3) Connect the RESP tubing set, nasal oxygen cannula, and humidification tank, and maintain
normal ventilation.
4) The ventilation time is about 30 minutes. When the battery is about to run out, verify that the
[Battery is about to run out] alarm is activated.
5) Reconnect the AC power supply to verify that the alarm is automatically reset and the
equipment is powered by AC power supply.

Chapter 3-7
3.5.5 Low O2 Source Pressure Alarm Test

1) Connect the equipment to the O2 source, adjust the O2 concentration to 40%, and validate
that the machine is working properly.

2) Turn off the O2 source, the machine continues to run, and verify whether the [Low O2
pressure] alarm is activated.
Attention: When the O2 source pressure is lower than 200Kpa, the low O2 source pressure alarm
is activated.

3.5.6 Too High O2 Concentration Alarm Test

1) Connect the O2 source.

2) Set the [O2 concentration] to 50% and start ventilation.

3) Manually adjust the upper limit of O2 concentration alarm to 40%.

4) Verify that the high-priority alarm of [O2 concentration is too high] is activated.

3.5.7 Too Low O2 Concentration Alarm Test

1) Connect the O2 source.

2) Set the [O2 concentration] to 50% and start ventilation.

3) Manually adjust the lower limit limit of O2 concentration alarm to 60%.

4) Verify that the high-priority alarm of [O2 concentration is too low] is activated.

3.5.8 Too High SpO2 Alarm Test

1) Press the power/standby button to switch on, and start ventilation.

2) Connect the SpO2 sensor and turn on the SpO2 monitoring function.
3) Connect the SpO2 sensor to the index finger, and set the lower limit of SpO2 alarm to 0%
and the upper limit of SpO2 alarm to 2%.
4) Verify that the alarm of [SpO2 is too high] is activated.

3.5.9 Too Low SpO2 Alarm Test

1) Press the power/standby button to switch on, and start ventilation.

2) Connect the SpO2 sensor and turn on the SpO2 monitoring function.
3) Connect the SpO2 sensor to the index finger, and set the upper limit of SpO2 alarm to 100%
and the lower limit of SpO2 alarm to 98%.

Chapter 3-8
4) Use the other hand to pinch the finger covered with the SpO2 sensor, the SpO2 value to be
monitored is less than 98%, verify that the alarm of [SpO2 too low] is activated.

3.5.10 Too High PR Alarm Test

1) Press the power/standby button to switch on, and start ventilation.

2) Connect the SpO2 sensor and turn on the SpO2 monitoring function.
3) 3. Connect the SpO2 sensor to the index finger, and set the upper limit of PR alarm to 15bpm.
4) 4. Verify that the alarm of [PR is too high] is activated.

3.5.11 Too Low PR Alarm Test

1) Press the power/standby button to switch on, and start ventilation.

2) Connect the SpO2 sensor and turn on the SpO2 monitoring function.
3) Connect the SpO2 sensor to the index finger, and set the upper limit of PR alarm to 300bpm
and the lower limit of PR alarm to 298 l/min.
4) Verify that the alarm of [PR is too low] is activated.

3.6 Electrical Safety Test

Attention

 After completing repairs or routine maintenance, electrical safety inspections shall be

performed. Before the electrical safety inspection test, all cover plates, panels and

screws shall be installed correctly.

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

 Please use a certified safety analyzer (such as UL, CSA or AAMI, etc.) and perform

relevant tests in accordance with its operating instructions.

3.6.1 Electrical Safety Inspection Test

1. Carry out the protective earth resistance test

1) 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.
2) Use 25A test current to perform the protective earth resistance test.

Chapter 3-9
 3) c Verify that the impedance value does not exceed 0.1ohms (100mohms).
4) 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 AC power socket, and
repeat steps a to c.

2. Carry out the earth leakage current test under the following conditions:
 Normal polarity
 Reverse polarity
 Open neutral, and normal polarity
 Open neutral, and reverse polarity

3. 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.

3.6.2 Electrical Safety Inspection Test

Testing site: Tested by:

Equipment under test: Hospital control number:
Manufacturer: Model: SN:
Testing equipment/SN: Calibration date:
Inspection and test Pass/Fail Limit
1 Protective earth resistance Ω Maximum:
0.1Ω
2 Earth leakage current Normal state μA Maximum:
Single fault μA Normal state:
state 500μ A
Single fault
state: 1000μ
A
During routine maintenance, all testing items in the electrical safety checklist shall be
performed.
After disassembling and repairing, if the power board is repaired or replaced, perform all the
testing items in the electrical safety checklist;
If the power board is not repaired or replaced, carry out the testing item 1 only.

Chapter 3-10
 Chapter 4 Calibration

Warning
 After repairing the equipment or replacing parts, perform calibration as needed.

4.1 Calibration and Zero Calibration of the Gas Source

Pressure Sensor

1) Connect the AC power supply, and press the power/standby button to switch on.
2) In the standby state, select the [Menu] button in the upper right corner, select the
[Configuration] -> [Maintenance] page, enter the password “5188”, enter the
maintenance interface, and enter the [Calibration] page.

Attention

 The NF1 model does not require calibration and zero calibration of the gas source
pressure sensor.

4.1.1 Pressure Zero Calibration

1) Select [Pressure Zero Calibration] in the calibration interface. Enter the interface in
the figure below:

2) Disconnect the O2 source, and ensure that there is no pressure when emptying the

Chapter 4-1
 O2 inlet of the machine.
3) Select the [Start] key to start zero calibration. As shown in the figure:

4) If zero calibration fails, please check whether the gas source and tubing set meet the
calibration requirements, and then calibrate according to the above steps.

4.1.2 Pressure Calibration

1) Select [Pressure Calibration] in the calibration interface. Enter the interface in the
figure below:

2) Connect the O2 source.

3) Adjust the input the gas source pressure to 400Kpa±10Kpa.
4) Select the [Start] key to start calibration. As shown in the figure:

Chapter 4-2
 5) If calibration fails, please check whether the gas source and tubing set meet the
calibration requirements, and then calibrate according to the above steps.

4.2 Turbine Calibration

1) Connect the AC power supply, and press the power/standby button to switch on.
2) In the standby state, select the [Menu] button in the upper right corner, select the
[Configuration] -> [Maintenance] page, enter the password “5188”, enter the
maintenance interface, and enter the [Calibration] page.
3) Select [Turbine Calibration] in the calibration interface. Enter the interface in the
figure below:

4) Install the humidification tank and connect the RESP tubing set to validate that the
air inlet and tubing set are not blocked.
5) Select the [Start] key to start calibration. As shown in the figure:

Chapter 4-3
 6) If calibration fails, please check whether the gas source, air inlet and tubing set meet
the calibration requirements according to the failure prompt information, and then
calibrate according to the above steps. As shown in the figure:

4.3 O2 Flow Calibration

Attention

 It is not applicable to NF1.

1) In the standby state, click the main menu to enter the last configuration page, select
[Maintenance] → enter the maintenance password “6699” to enter the factory
configuration interface.
2) Select [O2 Flow Calibration] in other interfaces. Enter the interface in the figure
below:

Chapter 4-4
3) Plug the turbine air inlet with a plug.
4) Select the [Start] key to start calibration. As shown in the figure:

5) If calibration fails, please check whether the gas source and tubing set meet the
calibration requirements according to the failure prompt information, and then
calibrate according to the above steps. As shown in the figure:

Chapter 4-5
4.4 O2 Calibration

1) Connect the AC power supply, and press the power/standby button to switch on.
2) In the standby state, select the [Menu] button in the upper right corner, select the
[Configuration] -> [Maintenance] page, enter the password “5188”, enter the
maintenance interface, and enter the [Calibration] page.
3) Select [O2 Calibration] in the calibration interface. Enter the interface in the figure
below:

4) Connect the O2 source to ensure that the O2 source pressure is within the range of
280Kpa~600Kpa, and it can be continuously and stably supplied.
5) Remove the humidification tank.
6) Select the [Start] key to start calibration. As shown in the figure:

7) If calibration fails, please check whether the gas source and tubing set meet the
calibration requirements according to the failure prompt information, and then
calibrate according to the above steps. As shown in the figure:

Chapter 4-6
4.5 Touch Screen Calibration

1) Connect the AC power supply, and press the power/standby button to switch on.
2) In the standby state, select the [Menu] button in the upper right corner, select the
[Configuration] -> [Maintenance] page, enter the password “5188”, enter the
maintenance interface, and enter the [Calibration] page.
3) Select [Screen Calibration].
4) Follow the cursor calibration points as prompted on the interface to touch
sequentially until the calibration is completed.

Chapter 4-7
 Chapter 5 Troubleshooting

5.1 Overview

This chapter will locate and eliminate the faults of the instrument’s hardware and electrical

system. After locating the faulty component, follow Chapter 5 Repair and Disassembly to

disassemble the equipment, and repair and replace the faulty component.

5.2 Technical Alarms and Diagnosis

Please pay attention to whether the instrument 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
instrument. For the causes and countermeasures of technical alarm information of other modules,
please refer to the user manual of this instrument.
The level column indicates the default alarm levels: H stands for high-level, M stands for
medium-level, and L stands for low-level.

5.2.1 Technical Alarms of the Main Control Board

Alarm Level Possible cause Measure

Battery in use L The AC power supply is 1. Check whether the AC power
disconnected;
supply is connected; if not, please
The AC fuse is blown;
reconnect the AC power supply;
Cable connection is
2. If the fault still exists, check and
poor;
The switching power make sure the cable is connected

supply fails; reliably;

3. If the fault still exists, please check

Chapter 5-1
 whether the fuse is blown; if it is

blown, please replace the fuse, or

contact our company;

4. If the fault still exists, please check

whether the switching power

supply is normal; if the switching

power supply is abnormal, replace

the switching power supply;

5. If the fault still exists, please

replace the monitoring board;

6. If the fault still exists, please

replace the main control bottom

board;

SpO2 sensor L The SpO2 probe fails; 1. Please restart the machine;
failure The SpO2 module fails 2. If the fault still exists, please replace
the SpO2 probe;
3. If the fault still exists, please replace
the SpO2 module;
SpO2 L The SpO2 probe is not 1. Check that the SpO2 probes are all
unknown connected or is not connected and connected in place;
probe connected in place or 3. If the fault still exists, please replace
damaged; the SpO2 probe;
The SpO2 module is 3. If the fault still exists, please replace
damaged the SpO2 module;
SpO2 module L The SpO2 module fails; 1. Please restart the machine;
error 2. If the fault still exists, please replace
the SpO2 module
SpO2 L The SpO2 module fails 1. Please restart the machine;
diagnosis error 2. If the fault still exists, please replace
the SpO2 module
NELL fault L The SpO2 module fails; 1. Please restart the machine;

Chapter 5-2
 resetting The SpO2 module 2. If the fault still exists, please replace
resets the SpO2 module;
Sensor error L The SpO2 probe fails; 1. Please restart the machine;
The SpO2 module fails 2. If the fault still exists, please replace
the SpO2 probe;
3. If the fault still exists, please replace
the SpO2 module;
SpO2 module L The SpO2 module is 1. Please restart the machine;
communication loosely installed; 2. If the fault still occurs, please check
error The SpO2 module fails; that the SpO2 module has been properly
The main control installed in place;
bottom board fails; 3. If the fault still occurs, please replace
The main control core the SpO2 module;
board fails; 4 , If the fault still exists, please change
the main control core board;
5. If the fault still exists, please replace
the main control bottom board;
Button H The main control 1. Check and ensure that the cable is
abnormality bottom board fails; connected reliably;
The encoder cable fails; 2. If the fault still exists, please replace
The shuttle board is the shuttle board;
abnormal; 3. If the fault still exists, please replace
the main control bottom board.

Key board H The main control 1. Please restart the machine;

failure bottom board is not 2. If the fault still exists, please check
properly connected to whether the main control bottom board
the main control core and main control core board are
board; installed in place; if they are not
The main control installed in place, please reinstall;
bottom board fails; 3. If the fault still exists, please replace
The main control core the main control core board;
board fails; 4. If the fault still exists, please replace
the main control bottom board.
Abnormal H The main control 1. Please restart the machine;

Chapter 5-3
communication bottom board and main 2. If the fault still exists, please check
between VCM control core board are whether the main control bottom board
and main not installed in place; and main control core board are
control board The wiring between the installed in place; if they are not
main control bottom installed in place, please reinstall;
board and the 3. If the fault still exists, check and
monitoring board is make sure the cable is connected
abnormal; reliably;
The main control 4. If the fault still exists, please replace
bottom board fails; the main control core board;
The main control core 5. If the fault still exists, please replace
board fails; the main control bottom board;
The monitoring board 6. If the fault still exists, please replace
fails; the monitoring board.

5.2.2 Technical Alarms of the Monitoring Board

Alarm Level Possible cause Measure

Please check the H/L The RESP tubing set 1. Reconnect the RESP tubing set
RESP tubing set is not connected or and ensure that it is installed in
has poor contact; place;
The RESP tubing set 2. If the fault still exists, replace
is damaged; the RESP tubing set;
Monitoring board 3. If the fault still exists, replace
failure the monitoring board;
Check for blockage H The humidification 1. Please check whether the related
tank, heating tubing components are blocked; if so,
set, nasal mask, and please replace the related
nasal catheter are components;
blocked.
Turbine abnormality H Turbine connection 1. Check whether the operating
fails; environment temperature of the
The turbine machine exceeds 28°C claimed by
temperature is too the manufacturer;

Chapter 5-4
 high; 2. If the fault still exists, check and
The turbine is make sure the cable is connected
damaged; reliably;
3. If the fault still exists, please
replace the turbine;
Temperature is too H The ambient 1. Check whether the operating
high temperature is too environment temperature of the
high; machine exceeds 28°C claimed by
The RESP tubing set the manufacturer;
is damaged; 2. Replace the new RESP tubing
The monitoring board set and ensure that the RESP
is damaged; tubing set is good;
3. If the fault still exists, please
replace the monitoring board;
Check the water H The water in the water 1. Fill the water tank with water;
level of the tank has been used up
humidification tank
Test for leakage H There is air leakage in 1. Please check whether the
the gas circuit; the humidification tank is installed in
humidification tank is place; if it is not in place, please
not installed or install the humidification tank
installed in place; the correctly;
RESP tubing set is 2. If the fault still exists, please
damaged. check whether the RESP tubing set
is in good condition and whether it
is installed in place; if the RESP
tubing set is damaged and the
installation is not in place, please
replace the good RESP tubing set
and install it in place;
3. If the fault still exists, please
check whether there is air leakage
inside the machine; if so, please
reinstall the relevant gas circuit

Chapter 5-5
 components or replace the seal
rings;
Check the operating H The operating 1. Check whether the operating
environment environment of the environment temperature of the
instrument is not machine exceeds 18~28°C claimed
within the scope of by the manufacturer;
the manufacturer’s 2. If the fault exists, enter the
promotion; maintenance interface to check
Atmospheric pressure whether the ambient temperature
sensor failure at of the machine is consistent with
ambient temperature; the outside temperature; if the data
difference is too large, replace the
atmospheric pressure sensor board;
System failure #1 M The CPU temperature 1. Check whether the operating
is abnormal, the environment temperature of the
ambient temperature machine exceeds 18~28°C claimed
is too high, or the by the manufacturer;
monitoring board fails 2. If the fault still exists, please
replace the monitoring board;
System failure #2 M Power self-test error 1. Restart the machine;
on the monitoring 2. If the fault still exists, please
board change the monitoring board.
System failure #3 M The communication 1. Restart the machine;
between the main 2. If the fault still exists, check and
control board and the make sure the cable is connected
monitoring board is reliably;
abnormal, which may 3. If the fault still exists, please
be caused by the replace the monitoring board;
failure of the main 4. If the fault still exists, please
control board or the replace the main control board;
monitoring board; or
the wiring between
the two is poor;
Over-temperature H The over-temperature 1. Restart the machine;

Chapter 5-6
disconnection switch of the heating 2. If the fault still exists, please
plate is abnormal; or reset the temperature control
the mica heating has switch;
over-temperature. 3. If the fault occurs again after the
instrument is re-run and heated,
please replace the
over-temperature protection
switch;
4. If the fault occurs again after the
instrument is re-running and
heating, please replace the
monitoring board;

Sensor failure #1 H The wiring of the 1. Restart the machine;

hybrid flow sensor is 2. If the fault still exists, check and
poor; make sure the cable is connected
The wiring of the reliably;
cable adapter board is 3. If the fault still exists, please
poor; replace the hybrid flow sensor;
The hybrid flow 4. If the fault still exists, please
sensor fails; replace the monitoring board;
The monitoring board
fails;
Sensor failure #2 M The wiring of the O2 1. Restart the machine;
flow sensor is poor; 2. If the fault still exists, check and
The wiring of the make sure the cable is connected
cable adapter board is reliably;
poor; 3. If the fault still exists, please
The O2 flow sensor replace the O2 flow sensor;
fails; 4. If the fault still exists, please
The monitoring board replace the monitoring board;
fails;
Sensor failure #3 M The wiring of the O2 1. Restart the machine;
sensor is poor; 2. If the fault still exists, check and
The wiring of the make sure the cable is connected

Chapter 5-7
 cable adapter board is reliably;
poor; 3. If the fault still exists, please
The O2 sensor fails; replace the O2 sensor;
The monitoring board 4. If the fault still exists, please
fails; replace the monitoring board;
Sensor failure #4 M The wiring of the 1. Restart the machine;
atmospheric pressure 2. If the fault still exists, check and
sensor board is poor; make sure the cable is connected
The atmospheric reliably;
pressure sensor board 3. If the fault still exists, please
fails; replace the atmospheric pressure
The monitoring board sensor board;
fails; 4. If the fault still exists, please
replace the monitoring board;
Unrealized flow M Airway blockage 1. Please check whether the
humidification tank, heating tube,
nasal catheter, air intake cover and
filter cotton are blocked; if it is
blocked, remove the blockage or
replace the corresponding device;
Unrealized M The humidification 1. Please check whether the
temperature tank is not installed or humidification tank is installed
not installed in place; correctly; if not, please install the
The ambient humidification tank correctly;
temperature is too low 2. If the fault still exists, please
or the machine flow is ensure that the operating
too high; temperature of the machine is
The heating of the within the range claimed by the
heating plate fails; manufacturer;
The temperature 3. If the fault still exists, reduce
detection at the fresh the target flow;
gas outlet is abnormal; 4. If the fault still exists, enter the
maintenance interface to check
whether the heating function of the

Chapter 5-8
 heating plate is normal; if it is
abnormal, please replace the mica
heating element;
5. If the heating is still abnormal,
please replace the monitoring
board;
6. If the heating function of the
heating plate is normal, but the
fault still exists, please enter the
maintenance channel to check
whether the fresh gas outlet
temperature is consistent with the
current ambient temperature; if the
difference is too large, please
replace the fresh gas outlet NTC;
O2 proportional M The wires are loose; 1. Please restart the machine;
valve failure The valve fails; 2. If the fault still exists, check and
Monitoring board make sure the cable is connected
failure reliably;
3. If the fault still exists, please
replace the O2 proportional valve;
4. If the fault still exists, please
replace the monitoring board;
Abnormal system L The monitoring board 1. Please restart the machine;
reset MCU resets; 2. If the fault still exists, please
replace the monitoring board;
Calibrate the gas L The gas source 1. Please recalibrate the pressure
source pressure pressure sensor is not sensor;
calibrated or the 2. If the fault still exists, please
calibration data is lost. replace the monitoring board
before calibration;
O2 source pressure H The pressure of the Check whether the gas source
is low connected gas source pressure meets the requirements of
is lower than 210KPa; 0.28~0.6MPa; if not, please

Chapter 5-9
 The gas source provide a gas source that meets the
pressure sensor board gas supply pressure requirements;
fails; 2. If the fault still exists, please
The monitoring board replace the gas source pressure
fails; sensor board;
3. If the fault still exists, please
replace the monitoring board;
O2 source pressure L The pressure of the Check whether the gas source
is high connected gas source pressure meets the requirements of
is higher than 0.28~0.6MPa; if not, please
700KPa; provide a gas source that meets the
The gas source gas supply pressure requirements;
pressure sensor board 2. If the fault still exists, please
fails; replace the gas source pressure
The monitoring board sensor board;
fails; 3. If the fault still exists, please
replace the monitoring board;

Filter cotton H The filter cotton at the 1. Take out the filter cotton at the
blockage turbine air inlet is gas source inlet, if the fault
blocked or the disappears, replace the filter
atmospheric pressure cotton; if the fault still exists,
sensor board fails. replace the atmospheric pressure
sensor board;

5.3 Hardware and Electrical System Failure

Fault Possible cause Troubleshooting

No AC power supply is Check and ensure that the AC
connected, and no battery is power supply is properly
When the machine is turned
equipped or the battery is low. connected.
on, the AC indicator and
The AC input socket fuse is Replace the fuse. If the fault
warning light are off, and the
blown, and no battery is still exists after replacing the
screen does not display, and
equipped or the battery is low. fuse, it indicates that there is a
the machine cannot start.
loose wire or a short circuit
inside.

Chapter 5-10
 The cable between the main Check and ensure that the
control bottom board and the cable is connected reliably.
monitoring board is detached
or the connection is unreliable.
The cable related to power Check and ensure that the
supply is detached or the cable is connected reliably.
connection is unreliable.
The hardware short circuit of Replace the AC/DC board.
the AC/DC board causes the
24V power supply failure and
the battery is low;
The DC input of the Replace the monitoring board.
monitoring board is
short-circuited, and the battery
is low;
The hardware failure of the Replace the monitoring board.
monitoring board results in no
5V and 12V output.
The wiring between the main Check and ensure that the
control bottom board and the cable is connected reliably.
When the machine is turned monitoring board is poor, so
on, the AC indicator is on, the that the power-on signal
alarm indicator is off, the cannot be transmitted to the
screen is off, and the machine monitoring board, or the
cannot be started. monitoring board cannot
supply power to the main
control bottom board;
The main control bottom board Replace the main control
fails, and there is no power-on bottom board.
signal output.
The wiring of the LCD screen Check and ensure that the
signal cable is poor. LCD screen wiring is good
and reliable.
The LCD screen does not
The hardware of the main Replace the main control
display (blank screen), and the
control bottom board fails, bottom board.
alarm horn can be heard.
causing the backlight power
supply to fail to output.
LCD is damaged. Replace the LCD.
The wiring of the LCD screen Check and ensure that the
The LCD screen does not signal cable is poor. LCD screen wiring is good
display (white screen). and reliable.
The hardware of the main Replace the main control

Chapter 5-11
 control bottom board fails, and bottom board.
there is no 3.3V output.
The main control core board Replace the main control core
fails, and there is no LCD board.
signal output.
There is a display on the LCD The wiring of the LCD screen Check and ensure that the
screen, but the color is signal cable is poor. LCD screen wiring is good
abnormal. and reliable.
The screen brightness cannot The hardware of the main Replace the main control
be adjusted. control bottom board fails, bottom board.
causing the backlight circuit to
fail to receive the backlight
signal.
The alarm indicator does not The hardware of the main Replace the main control
light up. control bottom board fails, and bottom board.
the alarm indicator cannot be
driven normally or the alarm
indicator is damaged.
Key failure The main control bottom board Replace the main control
fails. bottom board.
The wiring between the shuttle Check and ensure that the
board and the main control cable is connected reliably.
bottom board is poor.
The shuttle board is damaged. Replace the shuttle board.
Encoder operation failure
The hardware of the main Replace the main control
control bottom board is bottom board.
damaged, and thus the encoder
signal cannot be recognized.
The cable wiring of the touch Check and ensure that the
screen is poor. cable wiring is reliable.
The main control core board is Replace the main control core
damaged and cannot receive board.
touch signals.
The main control bottom board Replace the main control
fails and the touch signal bottom board.
Touch screen failure
cannot be transferred.
The touch screen is damaged. Replace the touch screen.
The calibration data of the Perform touch calibration
touch screen of the main again.
control core board is lost or the
touch screen calibration is not
performed.

Chapter 5-12
 The speaker-related wires are Check and validate the
detached or the connection is relevant wires are connected
unreliable. reliably.
The main control core board Replace the main control core
Speaker failure fails, and there is no audio board.
signal output.
The main control bottom board Replace the main control
fails. bottom board.
The horn is damaged. Replace the horn.
The socket of the Replace the USB-network
USB-network interface board interface board.
is in poor contact.
The main control bottom board Replace the main control
fails and the USB signal bottom board.
cannot be transferred.
USB cannot be recognized. The connection between the Check and ensure that the
main control bottom board and connection between the main
the main control core board is control bottom board and the
poor. main control core board is
good.
The hardware of the main Replace the main control core
control core board fails. board.
The AC indicator is off, the The hardware circuit of the Replace the main control
AC connection is normal, and main control bottom board bottom board.
there is no indication that the fails.
battery is in use.

Chapter 5-13
 Chapter 6 Repair and Disassembly

Warning

 Follow infection control and safety procedures. Used equipment may contain blood
and body fluids.
 Moving parts and detachable parts may present a little risk of crushing. Be careful
when moving and replacing system components.
 Be careful when disassembling parts with sharp edges to avoid cuts.
 When disassembling, please pay attention to prevent the screws from falling into the
equipment.

Attention

 When reassembling the components, check the aging condition of parts. Replace if
necessary.
 After replacing parts or repairing, test the product. Refer to Chapter 3 Inspection and
Test.

6.1 Preparation for Disassembly

6.1.1 Tools

When replacing components or maintaining, you may need the following tools:
 Phillips screwdriver
 Large flat head screws
 M3 Allen screwdriver
 Tweezers

6.1.2 Preparations

Before disassembly:
 Make sure that the heated respiratory humidifier is turned off and the AC power supply
is disconnected.
 Discharge the gas pressure in the heated respiratory humidifier as described below.
Chapter 6-1
  Disconnect the gas supply of all pipelines and gas cylinders.
 Validate that the heating plate of the heated respiratory humidifier has cooled to room
temperature, and the RESP tubing set and humidifying water tank have been removed.
 Prepare the tools required for disassembly.
 If the machine is fixed on the trolley, loosen the four thumbscrews under the fixed plate,
and remove the machine from the trolley.

Caution

 Internal parts may be contaminated during long-term use of the equipment. Please
wear special gloves during disassembly and inspection.

6.2 Disassembling the Heated Respiratory Humidifier

6.2.1 Disassembling the Main Unit

 Disassembling the upper shell assembly of the main unit

1. Remove the 4 M3 pan head screws fixed at the bottom, as shown in the figure:
2. Remove the upper shell assembly upwards (attention: the upper shell assembly can be
completely removed only after the cable is unplugged).

 Disassembling the front shell of the main unit

Chapter 6-2
1. Remove the 5 M3 pan head screws fixed at the bottom.
2. Unplug the L-shaped connection silicone tube and the cable related to the front shell
assembly.
3. Remove the front shell upwards.

Chapter 6-3
 Chapter 7 Parts

7.1 Main Components

7.1.1 Overall Unit

Serial No. Code Name Usage

1 082-000749-00 Flowmeter assembly 1

2 / Main unit 1

3 118-00000055-00 Column assembly 1

118-00000055-00 Tray assembly 1

4 118-00000055-00 Chassis assembly 1

Chapter 7-1
7.1.2 Chassis Assembly

Serial No. Code Name Usage

1 118-00000055-00 Base 1

2 118-00000055-00 Caster 4

Chapter 7-2
7.1.3 Main Unit Assembly

Serial No. Code Name Usage

1 115-007141-00 Upper shell assembly 1

2 051-001559-00 Monitoring board assembly 1

3 013-000011-00 Switching power supply 1

4 115-007137-00 Front shell 1

5 115-007138-00 Heating plate assembly 1

6 022-000113-00 Battery 1

7 043-004806-00 Baffle 1

8 043-004804-00 Bottom cover 1

9 115-007160-00 Gas circuit assembly 1

10 049-001326-00 Foot pad 4

11 043-005754-00 Bottom case 1

12 045-000661-00 Filter cotton 1

13 041-004938-00 O2 connector 1

Chapter 7-3
14 009-002037-00 Power assembly 1

Chapter 7-4
 Chapter 8 Maintenance and Care

8.1Maintenance Principle

Do not use a faulty device. Please have our authorized service representative to conduct
necessary repairs as far as possible, or have a qualified technician handle the replacement and
maintenance of the parts listed in this User Manual.
After the repair is completed, the device should be tested to ensure that it functions normally
and meets the specifications.

Attention
 Personnel with no experience in repairing such devices should not try to repair the
device.

 The main unit and accessories has been degreased for oxygen service prior to
deliveryand must be cleaned and disinfected before being submitted for inspection and
maintenance (including oxygen service).

 Replace damaged parts with parts manufactured or sold by our company.

 If you need service support, please contact our After-sales Services Department.

 If you want to know more about product information and related technical materials,
please contact our After-sales Services Department. We can provide documents of some
parts according to specific conditions.

 The hospital or institution using this device should establish a comprehensive

maintenance plan, otherwise it may lead to device failure and unpredictable
consequences, and may endanger personal safety.

 The patient cannot be connected during maintenance.

Chapter 8-1
8.2Maintenance Schedule

Minimum
maintenance Maintenance activity
times

Clean the external surface.

Every day Check the alarm function.

Check the electrical connector.

Check device integrity.

Inspect for physical damage.

Every 6 months Replace potentially damaged parts

Test the device’s performance and parameter calibration.

Check the SpO2 probe interface and safety protection device.

Every 1000
Replace the air cotton filter.
hours

During cleaning
and Check parts for damage and replace or repair if necessary.
maintenance

Replace the built-in battery. Please contact our After-sales Services Department
Every 3 years
for details.

8.3Battery Maintenance

Please check and replace the battery regularly. The battery life depends on the frequency and time
of use. If the battery is properly maintained and stored, the service life of the lithium-ion battery is
about 3 years. If the battery is used improperly, its life may be shortened. It is recommended to
replace the lithium ion battery every 3 years.
In order to ensure the maximum capacity of the battery, please pay attention to the following
instructions:
 A battery performance check must be performed every six months. Before the equipment is

Chapter 8-2
 repaired or when you suspect that the battery is the source of the fault, a battery performance
check is also required.
 When the battery is used every three months or when the running time of the battery is
significantly shortened, the battery needs to be optimized once.

Warning

 The service life of lithium-ion batteries is 3 years. When the lithium ion battery
reaches the end of its life, replace the lithium-ion battery.

 The lithium-ion battery is built in the instrument, and disassembly is required

when replacing.

 Battery specification & model: 022-000113-01 DC11.1V-2200MAH-24WH.

Caution

 Only use this equipment to charge the battery.

Attention

 In order to prolong the life of the battery, the battery should be used at least once a
month, and the battery should be charged when the battery power is almost
exhausted.

 Please check and replace the battery regularly. The battery life depends on the
frequency and time of use. If the battery is properly maintained and stored, the
service life of a lithium-ion battery is approximately 3 years. If the battery is used
improperly, its life may be shortened.

 When the battery fails, please contact the manufacturer and the designated
maintenance personnel will replace it. The user should not replace it by himself.

 During the charging process, the device can be used normally.

 The battery is a built-in part, and the instrument needs to be disassembled for
replacement.

Chapter 8-3
8.4 Filter Replacement

1) Disconnect the equipment power supply.

2) Press and hold the lower part of the air inlet cover plate, open the air inlet cover plate,
and remove the filter cotton.

3) Replace with new filter cotton, and then close the cover plate.

Warning

 Do not block the air inlet of the filter cotton during use.

8.5 Fuse Replacement

1) As shown in the figure, pull out the fuse cover from the AC power socket on the rear of
the instrument.

Chapter 8-4
 2) Replace the fuse, the specification and model is T3.0AL/250V, as shown in the figure
below:

Attention
 If you only replace the fuse, you do not need to disassemble the machine and replace it
directly outside the machine.

8.6Pollution-free Treatment and Recycling

 This device contains electronic components, please do not discard it with ordinary waste. A

High Flow Heated Respiratory Humidifier that is no longer used can be sent back to the

Chapter 8-5
 dealer or manufacturer where you purchased the product for proper recycling, or disposed of

according to the local regulations on the disposal of electronic devices.

 After use, please dispose the interface, RESP tubing set, humidification tank, and filter in a

garbage bag. The hospital should conduct final treatment according to its own standard

procedures for waste disposal.

 Used batteries can be disposed of in accordance with applicable laws and regulations.

Chapter 8-1
 Chapter 9 Software Upgrade

9.1 Software Iterative Upgrade

The equipment can use the USB flash drive for software upgrade.

The equipment can upgrade the following modules online:

 System software

 VCM software for monitoring

Caution

 Before upgrading, you must disconnect the equipment from the patient and back up
important data in the equipment.

Attention

 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 After-sales Service Department.

 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.

Chapter 9-1
9.2 Upgrade of USB Flash Drive

9.2.1 System Software Program Upgrade

1) USB flash drive in the FAT or FAT32 format, and the capacity is not more than 16G;
2) Create a SOFTUPDATE folder in the USB flash drive, and put the 4 files of logo.bmp,
root.yaffs2, u-boot.bin, and uImage of the system software program in the SOFTUPDATE
folder, as shown in the figure:

3) Insert the USB flash drive into the USB interface of the equipment, restart, and the equipment
will automatically upgrade. It takes about a few minutes. Please wait patiently until the
upgrade is successful, then pull out the USB flash drive, and then shut down and restart the
machine. At this point, the upper computer has been upgraded.

9.2.2 Monitoring VCM Program Upgrade

1) USB flash drive in the FAT or FAT32 format, and the capacity is not more than 16G;
2) Create the HFNC folder in the USB flash drive, and put the nf_vcm.bin file of the lower
computer program in the HFNC folder, as shown in the figure:

3) Insert the USB flash drive into the USB interface of the ventilator, in the standby state, click
the main menu to enter the last configuration page, select [Maintenance] → enter the
maintenance password 5188 to enter the maintenance interface.
4) In the maintenance interface, select [USB] to enter the [VCM Upgrade] interface.
5) The interface prompts the USB state, if it shows that the connection is successful, you can
upgrade.
6) The upgrade is successful, then unplug the USB flash drive, and then shut down and restart
the machine. At this point, the lower computer has been upgraded.

Chapter 9-2
 Appendix I Preventive Maintenance Report
of Heated Respiratory Humidifier

Hospital name

Department name

Maintenance engineer

Maintenance date

(DD/MM/YYYY)

i. Machine State Validation Before Maintenance

Cumulative system running time

(days/hours/minutes/seconds)

(In standby mode, select [Menu] ->

[Configuration] -> [Maintenance] ->

[Settings] -> [Time Information] in the

Serial No. upper right corner)

Turbine running time (hours)

(In standby mode, select [Menu] ->

[Configuration] -> [Maintenance] ->

[Settings] -> [Others] in the upper right

corner)

Software version System

(In standby mode, software

select [Menu] -> VCM

[Configuration] -> KB

[Maintenance] ->

Chapter 9-3
 [Settings] -> [Version

Information] in the

upper right corner)

Inspection item Operation Results

Data export Insert the USB flash drive into the USB □ Completed □

interface, and in the standby state, select Uncompleted

[Menu] -> [Configuration] ->

[Maintenance] -> [USB] -> [Data

Export] in the upper right corner

Ventilation state Select adult mode, connect the tubing set □ Pass

inspection and humidification tank, start ventilation, □ Fail

validate the normal ventilation and heating (Alarm )

of the machine, with no technical alarm

Visual inspection Check whether the machine and □ Pass

accessories are obviously damaged, if any, □ Fail

please attach pictures for recording

ii. Preventive Maintenance

Maintenance package replacement (refer to Section 8.3 Maintenance and Care)

Serial Inspection item Operation Results

No.

Filter cotton at the air Replace according to the □ Yes □ No □ Not

1
inlet manual steps involved

Calibration (refer to Chapter 4 Calibration)

Serial Inspection item Operation Results

No.

Pressure zero Follow the steps to calibrate □ Yes □ No □ Not

1
calibration successfully involved

Chapter 9-4
 (manufacturer)

Pressure calibration Follow the steps to calibrate □ Yes □ No □ Not

2
(manufacturer) successfully involved

Turbine calibration Follow the steps to calibrate □ Yes □ No □ Not

3
(manufacturer) successfully involved

O2 calibration Follow the steps to calibrate □ Yes □ No □ Not

4
(manufacturer) successfully involved

iii. Test After Maintenance

Accuracy inspection of the flow sensor (refer to Section 3.4.2)

Serial Flow (l/min) Actual flow value (l/min) Error Results

No.

1 2 Error: □ Pass □ Fail

2 30 ±1L/Min or □ Pass □ Fail

3 60 ±10% of the □ Pass □ Fail

80 set value, □ Pass □ Fail

whichever is

greater;
4
NF1 is only

tested up to

60 l/min

Accuracy inspection of the NF1 O2 concentration (refer to Section 3.4.1)

O2 flowmeter Measured O2 Actual O2 Error Results

Serial
flow (l/min) concentration concentration
No.
(%) (%)

2 5 Within the □ Pass □ Fail

range of 25
3 30 □ Pass □ Fail
vol.%~95
4 50 □ Pass □ Fail

Chapter 9-5
 vol.%: ±3
vol.% of the
actual
reading;

Other

ranges are

not defined;

Accuracy inspection of the NF2/NF3/NF5 O2 concentration (refer to Section 3.4.1)

Set O2 Measured O2
Serial Actual O2
concentration concentration Error Results
No. concentration (%)
(%) (%)

1 30 Within the □ Pass □ Fail

range of 25
2 50 □ Pass □ Fail
vol.%~95
3 90 □ Pass □ Fail
vol.%: ±3
vol.% of the □ Pass □ Fail

actual
reading;
4 100
Other

ranges are

not defined;

Accuracy inspection of the temperature (refer to Section 3.4.3)

Set O2 Measured O2
Serial Actual O2
concentration concentration Error Results
No. concentration (°C)
(°C) (°C)

1 31 ±2°C □ Pass □ Fail

2 34 □ Pass □ Fail

3 37 □ Pass □ Fail

Power failure alarm test

Serial Inspection item Results Remark

Chapter 9-6
No.

AC indicator inspection □ Pass □

1
Fail

Battery operating state inspection □ Pass □

2
Fail

AC power operating state inspection □ Pass □

3
Fail

Buzzer alarm time inspection (>120s) □ Pass □

4
Fail

Hospital suggestions

Engineer signature:

Date:

Department signature:

Date:

Chapter 9-7