Viatom LeRes-C User manual

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Non-invasive Ventilator
Shenzhen Viatom Technology Co., Ltd.
Instructions for Use

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Contents
1. Introduction................................................................................................................................................... 3
2. Product introduction....................................................................................................................................11
3. Preparation before use.................................................................................................................................16
4. Instructions for use......................................................................................................................................17
5. Common problem........................................................................................................................................27
6. Cleaning and maintenance.......................................................................................................................... 29
7. Maintain...................................................................................................................................................... 30
8. Storage and disposal....................................................................................................................................30
9. Attachment list............................................................................................................................................ 32
Appendix A Technical Specifications............................................................................................................. 32
Appendix B Electromagnetic compatibility................................................................................................... 41

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1. Introduction
Thank you for using Viatom Non-invasive Ventilator. This manual describes the purpose, function and safe use
of the device. Before using this device, please read carefully and fully understand the contents of this manual to
ensure the correct use of this device and the safety of patients and operators. Please keep this instruction manual
after reading it so that you can refer to it at any time when you need it.
Release version of the software : V1
1.1 Security Information
Before using this device, please read this manual carefully and fully understand the relevant warnings and risks.
Warning：Indicates possible harm to the user or operator.
Notice: Indicates possible damage to the device.
Warning：
●This manual is for reference only, and it needs to be used under the guidance of a professional doctor.
●This device is non-life support device.
●Do not wear a mask when the device is not turned on, otherwise there is a risk of suffocation.
●When the device is not turned on and is not working properly, please do not wear a mask to avoid the danger
of suffocation.
●This device should not be stacked or placed close to other unapproved device when in use.
●The device cannot be exposed to electrosurgery, defibrillation, X-ray (γ-ray) or infrared radiation. When the
electromagnetic field includes magnetic resonance (MRI) or CT inspection environment and radio interference
environment, the device will not operate normally in this environment.
●Portable and mobile radio frequency communication device may affect the use of this device. When using this
device normally, it is recommended to stay away from such communication device.
●If there is a mixture of flammable anesthetics and air or oxygen or nitrous oxide around, do not use this device.
●Do not use this device in an environment with flammable gas and oxygen-rich environment. The device should
be at least 1m away from the oxygen source during operation.
●Do not use the machine near the source of toxic gas or harmful gas.
●Do not use this device in a temperature exceeding the specified temperature range.
●Do not connect breathing tubes or accessories to unmarked humidifiers or device. Do not stretch the pipe,
which may cause air leakage in the pipe.
●Do not cover or heat the breathing circuit to affect the temperature of the air flowing into the patient.
●Do not place this device directly on carpets, fabrics or other flammable materials.
●Do not place the device near curtains to obstruct the flow of cooling air, which may cause the device to

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overheat.
●Do not use accessories or parts that are not recommended or configured. Incompatible accessories or
accessories can cause performance degradation or affect the EMC performance of the device.
●Condensation may damage the device. If the device is exposed to extremely hot or cold temperatures, the
device should be adjusted to room temperature (working temperature) before starting treatment. Do not use the
device in a temperature environment outside the operating temperature range indicated in the parameters.
●Do not use this device when the room temperature exceeds 35°C (95°F). When the room temperature exceeds
35°C (95°F), the air temperature in the duct may exceed 43°C (109°F). Thereby causing irritation or injury to
the respiratory tract.
●Do not use this device under direct sunlight or near heating device, as these conditions will increase the
temperature of the output airflow of the device.
●If the environment or power supply exceeds the specification range, it may cause automatic shutdown or the
ventilation control cannot meet the specifications.
●When you use this device in a home environment, you need to place this device away from pets and children.
●Please check if there is water in the device before use. The maximum water level limit of the water tank is
260ml.
●Before use, please confirm that the tubing is properly connected and avoid the risk of neck winding caused by
the use of breathing tubing and hoses. Check the pipeline for damage or wear, and replace the pipeline if
necessary.
●The patient is the intended operator. The patient can safely use the treatment function of the device. When the
patient is using it, the parts of the device cannot be maintained or repaired.
●When using oxygen, the oxygen supply must comply with local standards for medical oxygen. It is forbidden
to connect the device to an uncalibrated or high-pressure oxygen source. Please do not use oxygen when you
smoke or have an open flame to avoid burning. The distance between the device and the oxygen source should
be at least 1m to avoid fire and burns.
●When using oxygen, please turn on the machine before turning on the oxygen. Turn off the oxygen before
turning off the machine. Prevent oxygen from accumulating in the machine. Warning explanation: When the
machine is not working and the oxygen is still on, the oxygen transmitted to the hose can accumulate in the
machine casing. The oxygen accumulated in the machine casing poses a fire hazard. Do not connect this device
to an uncontrolled or high-pressure oxygen source.
●Incorrect use of masks or accessories may cause the CO2 concentration to increase to a critical value or allow
unconscious breathing, which may cause breathing suffocation.
●Do not block the exhaust port of the mask. If you are using a full face mask (the mask covers your mouth and
nose), the mask must be equipped with a safety (entrainment) valve.
● Repairs, services and maintenance should only be performed by the manufacturer or technicians expressly

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authorized by the manufacturer. Repairing the machine without authorization may result in personal injury,
invalidation of the warranty or damage to valuable parts.
●If apnea continues to occur after using this device, please contact a professional doctor.
●No modification to the device is allowed. If you want to dispose of this device, please follow local
environmental regulations.
●When you need to measure blood oxygen and ECG, please refer to the user manual of the appropriate oximeter
and ECG.
Other equipment connected to the signal port of the product must meet the requirements of relevant standards,
such as IEC 60601-1 or IEC 62368-1, etc.
Do not place the device where it is difficult to disconnect the power supply.
Although the device has passed ISO10993 and ISO 18562 tests, the easily accessible materials of the device
may cause allergic reactions.

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Notice：
●Before use, make sure that the power cord is firmly installed to your treatment device.
●The correct wearing and position of the mask on the face is essential for the consistent operation of the
device.
●When using, it must be ensured that the filter cotton is in good condition and installed in place.
●Cigarette smoke will cause the accumulation of smoke in the machine, which will cause the machine to fail
to work normally.
●It is necessary to check the filter cotton regularly to ensure that it is completely clean. Dirty filter cotton
may increase the working temperature and affect the performance of the device. Do not use wet filter cotton,
you need to ensure that there is sufficient drying time.
●When the gas flow rate and setting exceed the recommended working range, the output of the
humidification system may be insufficient, and the relative humidity of the output gas may be less than
70%.
●In order to be able to use the humidifier safely, the humidifier must be placed below the breathing circuit
between the mask and the air outlet of the device.
●Please regularly check whether the power supply and various pipelines are normal. If there is any problem,
please stop using the device and replace related accessories. Please disconnect the power before cleaning
the device to avoid electric shock. Do not immerse the device in water or other liquids. Please pay attention
to waterproofing.
●When the accidental damage of the physical media causes system failure, power failure, hardware failure,
and software failure, the protection of the physical environment should be strengthened, and the use of
device should be strengthened.
●When man-made threats cause accidental loss of backup data, network management policies should be
carefully improved; effective management of network keys should be strengthened, and misoperations
should be prevented.
●When the user’s personal information is unintentionally disclosed, the user’s identification and
authentication mechanism should be adopted, and the password should be long enough; it should be
changed frequently, and the password should be kept in a confidential place; at the same time, the security
awareness of personnel should be strengthened and the scope of the spread of confidential information
should be controlled , Encrypt the information transmitted in the network, etc.
●Please follow the doctor's advice and consider changing the treatment pressure. In order to make the
treatment effect of the device more effective, please re-evaluate the treatment settings regularly.
●Ensure that the treatment pressure of the patient is individually set for the patient according to the
configuration of the device used, including accessories.
●When the treatment device is used by multiple patients, each patient needs to be equipped with a separate

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breathing circuit and mask, and other people's cannot be used.
●If you feel uncomfortable when using the device, please stop using the device and contact the device
provider immediately. Because it may cause allergies.
●If the machine has abnormal working conditions, such as abnormal noise, falling, water entering the
machine, or breaking of the machine shell, please disconnect the power supply, stop using the machine, and
contact the device provider immediately.

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1.2 Graphics and symbols
This device uses the following symbol identification, and its meaning is explained in the table below.
Symbol
Description
Indicates the item is a medical device
Follow Instructions for Use.
Indicates the need for the user to consult the instructions
for use
Indicates that caution is necessary when operating the device or
control close to where the symbol is placed, or that the current
situation needs operator awareness or operator action in order to
avoid undesirable consequences
Indicate separate collection for electrical and electronic device
(WEEE).
Indicates the medical device manufacturer
Indicates the date when the medical device was manufactured
Serial Number
Indicates the date after which the medical device is not
to be used
Class II (Double Insulated)
≥ 12.5 mm Diameter, Dripping (15ºtilted)
Type BF Applied Part
AC Power
DC Power
Non-Ionizing Radiation

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Symbol
Description
Ramp Button
Start/stop therapy button
This product complies with the Europea
Council EU 2017/745 (MDR)
Authorized representative in the European Community
Indicates a carrier that contains unique device identifier
information
The product has passed FCC certification

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1.3 Terms and definitions
Terms
Description
CPAP mode
Continuous positive airway pressure
The device performs continuous positive pressure ventilation
according to the set treatment pressure, and the treatment pressure is
the same in the inspiratory and expiratory phases.
APAP mode
Automatic continuous positive airway pressure mode APAP can be
called Auto CPAP mode.
When the device is ventilating, when a respiratory event is detected,
the treatment pressure is automatically increased, and when the
respiratory event disappears, the treatment pressure is automatically
reduced, that is, the pressure is automatically adjusted by judging
that the respiratory event is within the set pressure range.
S mode
Autonomous trigger mode.
When the device is ventilated, the patient's own breathing is used to
control the operation of the device (the device provides inspiratory
pressure when inhaling, and the device provides expiratory pressure
when exhaling), and the breathing rate of the device is fully
synchronized with that of the patient.
S/T mode
Autonomous trigger/time mode.
When the device is ventilated, if the patient breathes well on their
own, the device and the patient's breathing rate are kept fully
synchronized; if the patient's breathing is unstable or stops, the
device will ventilate the patient according to the preset pressure and
breathing rate.
T mode
Time control mode.
When the device ventilates, the patient is ventilated according to the
set pressure and respiratory rate and other parameters. This mode is
mainly suitable for patients with weak breathing trigger ability.

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2. Product introduction
2.1 Product name and model
Product name：Non-invasive Ventilator
Model：LeRes-C, R10, LeRes-A, R20, LeRes-C1, R11, LeRes-A1, R21, LeRes-S, R100, LeRes-B, R200, LeRes-S1, R101, LeRes-B1, R201.
Product models are divided according to different product configurations, see the table below for details:
Model
configurations
LeRes-
B
R100
LeRes-
S
R200
LeRes-
B1
R101
LeRes-
S1
R201
LeRes-
C
R10
LeRes-
A
R20
LeRes-
C1
R11
LeRes-
A1
R21
Colour
Black
Black+
Blue
Black
Black+
Blue
Black
Black+
Blue
Black
Black+
Blue
White
White
+Blue
White
White
+Blue
White
White
+Blue
White
White
+Blue
CPAP mode
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
APAP mode
○
○
●
●
○
○
●
●
○
○
●
●
○
○
●
●
S mode
●
●
●
●
●
●
●
●
×
×
×
×
×
×
×
×
S/T mode
●
●
●
●
●
●
●
●
×
×
×
×
×
×
×
×
T mode
●
●
●
●
●
●
●
●
×
×
×
×
×
×
×
×

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WIFI
○
○
○
○
○
○
○
○
○
○
○
○
○
○
○
○
Bluetooth
○
○
○
○
○
○
○
○
○
○
○
○
○
○
○
○
Turbo code
B
B
B
B
C
C
C
C
A
A
A
A
C
C
C
C
Note: 1. "●" stands for standard configuration; "○" stands for optional configuration; "×" stands for none.
Turbine information is disclosed in technical documents.

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2.2 Intended Use
It is intended for relieve obstructive sleep apnea(OSA)and Chronic obstructive pulmonary
disease(COPD) in patients weighing more than 30Kg, So as to achieve the purpose of adjuvant
therapy. It cannot be used for life support and treatment central sleep apnea. It needs to be used
under the guidance of a professional doctor.
2.3 Product structure and composition
It consists of host, power adapter and humidifier.
2.4 Contraindication
When patients with the following conditions may not be suitable for treatment with a positive
pressure ventilation therapy machine, please inform your doctor before using this device. Only
after a doctor's examination and diagnosis, can this device be used for treatment:
Absolute contraindications: pneumothorax; pneumomediastinum; cerebrospinal fluid leakage,
craniocerebral trauma or intracranial trauma or intracranial pneumoconiosis; shock caused by
various causes and has not been corrected; epistaxis is active; epistaxis has not been effectively
controlled Gastrointestinal bleeding; coma or unconsciousness that cannot cooperate or receive
mask treatment; huge vocal cord polyps; severe insufficiency of effective circulating blood
volume with shock.
Relative contraindications: severe coronary heart disease with left heart failure; acute otitis
media; excessive respiratory secretions and weak cough;
Spontaneous breathing is weak; tracheal intubation (through the nose or mouth) and tracheotomy;
severe nasal congestion caused by various reasons; pulmonary bullae; respiratory mask allergy.

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2.5 Host appearance
No.
Component
Description
1
USB interface
USB data interface, connect external device
2
Display screen
Display system menu, support touch operation
3
Air outlet
Connect breathing circuit here
4
Water tank
Place the water needed for the humidifier
5
Indicator light
Indicating effect
6
Home button
Click to return to the main interface of the system
7
Delay boost button
Click to set the delay boost time
8
Radiator cap
Open the water tank cover to extract the water tank
9
Start/stop button
Start and stop device ventilation
10
Air inlet
The air inlet of the device, the installation position of the filter
cotton
11
Power socket
Connect the power cord here

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2.6 Humidifier use
During the use of the device, turning on the humidifier to heat and humidify can increase
the humidity of the inhaled air, prevent the nasal mucosa from drying out, and improve the
comfort of use. If you need to enable the humidification function, you need to add water to the
water tank so that the humidifier can work normally. Please follow the steps below:
1. Open the water tank cover and take the water tank out of the humidifier.
2. Pour water into the water tank, the water volume does not exceed the highest water level
line of the water tank.
3. Put the water tank back into the humidifier and buckle the water tank cover.
Notice ：
●Only distilled water or purified water can be filled, and the amount of water added each time
should not exceed the highest water level line of the water tank.
●When the water volume of the water tank reaches the highest water level, do not tilt the
water tank.
●When the device is not in use, please pour out the remaining water in the water tank.
●Do not touch the metal surface of the heater when pulling out the water tank.

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3. Preparation before use
Before using the device, please read this chapter carefully and follow the instructions in this
chapter to install, connect and check the device.
For accessories used with this device, please check in accordance with the instruction manual of
each accessory.
3.1 Place
Please place the device horizontally on a safe and reliable platform. Do not place the positive
pressure ventilation therapy machine around any heating or cooling device (fans, radiators, air
conditioners).
Notice:
●When placing the machine, make sure that the power cord is accessible, because cutting off the
power is the only way to turn off the device.
● Make sure that the air inlets of the device are not blocked by sheets, curtains and other things.
●Do not place it directly on carpets, fabrics or other flammable materials.
●Do not place it directly on a container with water.
3.2 Install the filter
The air inlet of the device is equipped with reusable filter cotton, and the device can only be
used after the filter cotton is installed. Please check the filter every 1-3 months. If there is any
foreign matter or dust blocking the air inlet, please clean or replace the filter cotton.
Please follow the steps below to install the filter:
1. Open the side cover of the device.
2. Place the cotton filter in the filter of the air inlet and replace it on the side panel.
If it is to replace the filter cotton, take out the old filter cotton and put in a new one.
Note: After receiving the device, please confirm whether the filter is installed in the air
inlet. If the filter is not installed, please install the filter before using the device.
3.3Connect the power supply
Please follow the steps below to connect the power supply:
1. Connect one end of the power cord to the power adapter, and plug the other end into the
power socket;

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2. Connect the power adapter to the power socket of the device;
3. Make sure that the plugs of the device end, power adapter and socket have been inserted
firmly.
Warning：
●If the power supply is disconnected during the use of the device, the device buzzer will emit
a "di di..." prompt sound, please stop using it and check the power connection.
●When the device is damaged, please do not connect to the power supply.
●If the surface of the power adapter or power cord is damaged, please stop using the device
and replace the adapter or power cord.
3.4 Connect tubing and mask
Please follow the steps below to connect the tubing or mask:
1. Connect one end of the pipe to the air outlet on the top of the device.
2. Connect the other end of the tubing to the mask.
3. Wear the face mask, adjust the tightness of the headband of the face mask, so that the
face mask fits the face and does not leak air.
Notice:
●Do not pull the pipeline to avoid air leakage.
●If the mask and pipeline are damaged, please stop using it and replace it in time.
3.5Device Operation Guide
The user interface of this device allows you to adjust device settings and check your treatment
information. The user interface includes a display screen and a touch screen and buttons. Touch
the screen to select various options or settings on the screen.
Ventilation button-press it to start ventilation, press and hold for 5 seconds to stop ventilation.
Ramp function touch button: press it to quickly enter the Ramp menu page
Home function touch button: press to return to the first page
Note: The screen examples shown in this manual are for reference only, and the actual screens
may vary according to different machine models and vendor settings.
4. Instructions for use
This chapter introduces the basic operations and precautions related to the device.

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4.1 Power on/off
Turn on: The device will automatically turn on after it is connected to the power source.
After a few seconds, the device will enter the standby state.
Shutdown: When the device is in a non-ventilated state, disconnect the power supply to
automatically shut down. Shutting down under ventilation will trigger a power-down alarm.
4.2 Initiate ventilation
Start ventilation: After connecting the pipe pavement cover, press the "Start/Stop" button,
the device will begin to ventilate, and the display will show parameter information such as
treatment pressure.
Stop ventilation: During ventilation, press the "Start/Stop" button, and the device will stop
ventilation.
Notice:
1. During the ventilation process, when the device has a power interruption (such as a
power failure), if the power supply is restored within 60 minutes, the device will automatically
return to the ventilation state before the power failure.
2. Under normal conditions: there is a leak hole on the full face mask. When the patient
exhales, the exhaled carbon dioxide is squeezed out from the leak hole through the patient's
exhaled pressure and the pressure output by the ventilator.
3. In a single fault state: when the power is off, when the patient exhales, the exhaled
carbon dioxide is simultaneously squeezed out from the leak hole and breathing tube on the
mask, and fresh gas is inhaled from the leak hole and breathing tube when inhaling.
4.3 Humidification function
When using the device, you can turn on the humidification function to heat and humidify the gas
output by the device. Select the [Humidification] menu and set the humidification level. After
opening the ventilation, the device will automatically start the humidification function.
Note: When turning on the humidification function, please make sure that there is enough water
in the water tank to avoid dry-burning the humidifier.
4.4 Delay boost function
The delayed pressure boost function can make the pressure output by the device gradually rise

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from the initial pressure and reach the set treatment pressure after a preset time, making it easier
for the user to fall asleep. Select the [Comfort] menu, set [Delay Boost Pressure] and [Delay
Boost Time] to enable the delay boost function.
4.5 View report
When the device is in standby mode, you can view the usage of the device in the report menu
interface, and the duration of this ventilation, average usage time, etc. will be displayed. Select
the [Report] menu, the day's usage data will be displayed by default, and you can select other
usage times for query.
4.6 Function menu description
The system will display different menu items according to different user types, including three
modes of menus: normal mode, advanced mode, and maintenance mode. After the device is
started, it enters the normal mode by default.
Standby interface Ventilation interface
4.6.1Normal mode menu
This mode is mainly operated by the patient, and the device can be set. The normal mode
menu mainly includes humidification setting, comfort setting, system setting, view report, etc.
For detailed menu description, please refer to the following table.
Menu interface Comfort setting interface

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Menu
Function Description
Humidify
Humidification
grade
Set the humidification level of the humidifier, optional values:
automatic, 0-5 gears;
Level 0 is to turn off the humidification function. The greater the
number of levels, the greater the humidification capacity. The
default is 0 level.
Comfort
Expiratory
hypotension
Set the level of expiratory pressure reduction, and automatically
reduce the pressure in the mask according to the breathing rhythm
during the expiration phase to improve comfort. Optional values:
0-3 gears, 0 gear is to turn off this function, default value: 2 gears.
Automatic start
Turn on/off the automatic ventilation function; when turned on,
the device will automatically start ventilation after the user wears
the mask and breathes; Optional value: on/off, the default value is
on.
Automatic stop
Turn on/off the automatic stop ventilation function; when turned
on, the device will automatically stop the ventilation after
detecting that the user takes off the mask; Optional value: on/off,
the default value is on.
Delay start
pressure
Set the starting pressure of the delay boost function. Optional
value 3-20cmH2O,
Default value: 4 cmH2O.
Note: The initial pressure value must be less than the set pressure
value.
Delay boost
time
Set the delay time of the delay boost function, optional value:
0-60 minutes, when set to 0, the delay boost function will be
closed, default value: 15 minutes.
Preheat
Turn on/off the pre-heating function. After turning on, the
humidifier will start to work for 30 minutes before being
ventilated to pre-heat.
Report
View usage
information
Display the usage of the device, including usage time, sleep
quality information, etc.