Yuwell YH-480A User manual

User manual
BreathCare PAP
Positive Airway Pressure Units
Suzhou Yuyue Medical Technology Co., Ltd.
No.9 Jinfeng Road, Suzhou Science & Technology Town,
215163 Suzhou, Jiangsu, PRC
TEL：[phone]
web address: www.yuyue.com.cn
IFU-V-68: version 01
Prepare date: 2021-12
1030400-0A
Paper

Warning
Welcome
The YH-480A is Yuwell’s Auto Continuous Positive Airway Pressure
devices (Auto CPAP).
Read this entire user manual before using the device.
Caution
This device is restricted to sale by or on the order of a physician.
1. Warnings and cautions ..........................................................................01
2. Introduction............................................................................................03
3. Scope of application ..............................................................................03
4. Contraindications and adverse effects .................................................03
5. Package table........................................................................................04
6. Picture and explanation for product.......................................................04
7. Explanation of button.............................................................................05
8. Installation .............................................................................................05
9. Therapy .................................................................................................06
10. Function ..............................................................................................07
11. Caring for your device..........................................................................11
12. Therapy data .......................................................................................14
13. Traveling .............................................................................................14
14. Trouble shooting ..................................................................................14
15. Specication of technology..................................................................16
16. Symbols...............................................................................................19
17. Limited warranty ..................................................................................20
18. Repairing .............................................................................................21
19. List of cables........................................................................................21
20. Technical description ...........................................................................21
21. Warranty card .....................................................................................24
Content

01 02
1. Warnings and cautions
Warning
• Do not maintain the device while it is in use, otherwise it may lead to unacceptable risk.
• Do not modify this equipment without authorization of the manufacturer or open this device by
yourself, contact your provider or Yuwell when the device need to be repaired.
• This device cannot be used for life support. It may be shut down by turning off the electricity, but
no unacceptable risk will happen.
• The device can't be used in the environment where the air is mixed with ammable anesthetic
gases or nitrous oxide gases. (Non-AP and Non-APG series PAP)
• The sources of oxygen must be located more than 1 m from the device to avoid the risk of re
and burns.
• Supplemental oxygen must not be used while smoking or in the presence of an open ame.
• Always make sure that the device is turned on and airow generated before the oxygen supply
is turned on. Always turn the oxygen supply off before the device is turned off, so that unused
oxygen will not accumulate within the device enclosure or create a risk of re.
• Make sure that you arrange the cables and heated tubing so that they will not twist around the
head or neck. Otherwise it may result in strangulation.
• If you notice any unexplained change in the performance of the device, if it is making unusual
sounds, if the device or the power supply are dropped or mishandled, or if the enclosure is
broken, discontinue use and power off the equipment, then contact your provider or Yuwell.
• Do not place the device where it can be bumped or where someone is likely to trip over the
power cord.
• Do not block the heated tubing and/or air inlet of the device while in operation otherwise it could
cause overheating of the device.
• Keep the area around the device dry, clean and clear of anything (e.g. clothes, bedding, lint,
dust or direct sunlight) that could block the air inlet, cover the power supply unit, affect patients’
breathing or reduce the life of device.
• Place the device on the stable table. Placing device on the soft, out of flatness surface is
forbidden.
• Keep the device far away from water.
• Make sure the power cord and plug are in good condition and the equipment is not damaged.
• Keep the power cord away from hot surfaces.
• Beware of electrocution. Do not immerse the device, power supply or power cord in water. If
liquids are spilled into or onto the device. Unplug the device and let the parts dry naturally and
contact your provider or Yuwell.
• Always unplug the device before cleaning and make sure that all parts are dry before plugging it
back in.
• This device cannot be used for multiple patients.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because
it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
• Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
• Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the device,
including cables specied by the manufacturer. Otherwise, degradation of the performance of
this equipment could result.
• Interconnection of this equipment to other equipment which is not the supply one is forbidden.
• Nebulisation or humidification can increase the resistance of breathing system filters and
the operator must monitor the breathing system lter frequently for increased resistance and
blockage to ensure the delivery of the therapeutic pressure.
• Failure to use a mask or accessory that minimizes rebreathing of carbon dioxide or permits
spontaneous breathing can cause asphyxiation.
• Keep device far away from the following environments, e.g. magnetic fields, electromagnetic
elds, external electrical inuences, electrostatic discharge, pressure or variations in pressure,
acceleration, thermal ignition sources and so on.
• Do not block the several holes in your mask, otherwise it will result in strangulation.
• Humidity performance of the device can be compromised when used outside the specified
ambient temperature range or humidity range.
• The performance of the device can be compromised when exposed to environment, for
example, electrocautery, electrosurgery, debrillation, X-ray(gamma radiation), infrared radiation,
conducted transient magnetic fields, magnetic resonance imaging (MRI), and radiofrequency
interference.
• When the device is used near the children or disabled persons, the device must be supervised.
Do not let the children or disabled persons inhale or swallow small parts. Otherwise, it may result
in choking.
• Keep the area around the device dry, clean and clear of anything (eg, pets, pests or children)
that could affect the device hygiene, drop the device, and so on.
• The device is intended for single patient use only. Do not let others use it.
• Covering breathing tubes with a blanket or heating them in an incubator or with an overhead
heater can affect the quality of the therapy or injure the patient.
• Do not use the humidifier above an altitude of 3000 meters or outside a temperature of
+5℃~ 35℃. Using the humidier outside of this temperature range or above this altitude can
affect the humidier performance.
• Prevent disconnection of the tubing or tubing system during use, especially during ambulatory
use, only tubes in compliance with ISO 5367 or ISO 80601-2-74 should be used.
Caution
• Using only Yuwell part and accessories with device. Non-Yuwell parts may reduce effectiveness
of the treatment and/or damage the device.
• Use only vented masks recommended by Yuwell or by your doctor with this device. Fitting the
mask without the device blowing air can result in rebreathing of exhaled air. Make sure that the
mask vent holes are kept clear and unblocked to maintain the ow of the fresh air into the mask.

03 04
• If you use the humidier, always place the device on a level surface lower than your head to
prevent the mask and heated tubing from lling with water.
• Leave the water tank to cool for ten minutes before handling to allow the water to cool and to
make sure that the water tank is not too hot to touch.
• Make sure that the water tank is empty before transporting the device.
• The proper placement and positioning of the mask on the face is critical to the consistent
operation of this equipment.
• Not intended for use with patient whose upper airways have been bypassed.
• The time required for the device to warm from the minimum storage temperature between uses
until the device is ready for its intended use when the ambient temperature is 20℃is about 2
hours.
• The time required for the device to cool from the maximum storage temperature between uses
until the device is ready for its intended use when the ambient temperature is 20℃is about 2
hours.
• This device is not intended for children, and patients who are physically or mentally decient
can’t use the device without assistance or supervision.
• The patient is an intended operator at home.
2. Introduction
The YH-480A self-adjusting devices is indicated for the treatment of Obstructive Sleep Apnea (OSA)
in patients weighing more than 66 lb(30 kg). It is intended for home and hospital/institutional use.
The YH-480A consists of main device, water tank, power adapter and cable. Mask and heated
tubing are purchased.
3. Scope of application
BreathCare PAP is a kind of the device which provides positive airway pressure to patient’s airway.
This therapy can make patient sleep better.
4. Contraindications and adverse effects
f4.1 Contraindications:
Positive airway pressure therapy may be contraindicated in some patients with the following
preexisting conditions:
• Severe bullous lung disease
• Pneumothorax
• pathologically low blood pressure
• Dehydration
• Cerebrospinal uid leak
• Recent cranial surgery or trauma
f4.2 Adverse effects:
You should report unusual chest pain, severe headache, or increased breathlessness to
your prescribing physician. An acute upper respiratory tract infection may require temporary
discontinuation of treatment.
The following adverse reactions may arise during the course of therapy with the device:
• Drying of mouth, nose, or throat
• Nosebleed
• Bloating
• Ear or sinus discomfort
• Eye irritation
• Skin rashes
5. Package table
Item Quantity Item Quantity
Main device 1 Mask (with mask accessories) 1
Water tank 1 Air lter 2
Heated tubing 1 User manual 1
Power adapter and Cable(as part
of the device)
1 Bag 1
6. Picture and explanation for product
START/STOP button
Screen
Dial
Water tank
Main device
Air filter
Heating wire
connection
Air outlet of main
device to water tank
Air outlet of
main device
Heater plate
Air outlet
Power interface
Manufacturer reserved, no use
USB interface (for USB flash
disk only)

05 06
Air outlet of
water tank
Air inlet of water tank
Water line
Cover of
water tank
Container of
water tank
7. Explanation of button
START/ STOP button: press to start /stop therapy.
Dial: turn to navigate the menu and press to select an option. Turn to
adjust the options and press to save your choice.
8. Installation
The following section will help you install your device by yourself
2
1
4
3
6
5
1. Place the device on a stable level surface; Hold the water tank at the top and bottom, press it
gently and pull it away from the device;
2. Open the water tank and ll it with distilled water up to the maximum water level mark. Do not ll
the water tank with hot water;
3. Close the water tank and insert it into the side of the device;
4. Plug the power connector into the rear of the device;
5. Connect the heated tubing rmly to the air outlet located on the rear of the device;
6. Fit your mask correctly (refer to the mask manual) and connect the free end of the heated tubing
rmly onto the mask and press the start button to begin treatment.
Caution
• Please change the distilled water in the water tank every day.
• Do not add the distilled water above the maximum water level mark, in case the water may enter
the heated tubing and the device.
• Appliance coupler or mains plug is used as the isolation means from mains supply, not to
position the equipment so that it is difcult to operate the disconnection device.
• When the humidity level is 6 and the therapy pressure is 20 cmH2O, 8 hours is an expected
duration of operation before rells.
9. Therapy
f9.1 Start therapy
1. Power on your device;
2. Fit your mask;
3. Press Start / Stop button or breathe normally if Smart Start / Stop is enabled, therapy will start.
During the therapy, the real-time average pressure, the set pressure, the ramp time (min), and
the humidity level will all be displayed on the screen;
4. During the ramp time, the pressure increased gradually until the setting pressure has been
reached;
5. The screen will go black automatically after about one minute. You can press any button to turn
it back on.
Caution:
• When the level of the humidity is 1-6 and the device is delivering gas pressure, the heating plate
will heat (including the situations that the screen shows “Large Leakage” and the backlight of the
screen is off).

07 08
• When the level of the humidity is 0, the heating plate is not heating. Also if the device is not
delivering gas pressure, the heating plate will not heat either.
f9.2 Stop therapy
1. Remove your mask;
2. Press the Start / Stop button or the therapy will stop automatically after about one minute when
the Smart Start / Stop is enabled;
3. To power off your device, please separate the plug from the electricity.
10. Function
f10.1 Function that patient can safely use
10.1.1 Information:
You can read summary of sleep report on information page. Following parameters will be displayed.
• AHI: Indicates the number of apneas and hypopneas per hour.
• Used Time (h): The time duration for the last therapy (h).
• Treatment Time (h): The time of the patient wore the mask (h).
• Average Pressure: The average pressure for the last therapy (cmH2O/ hPa).
• Average Leakage (Lpm): Average air leak volume per minute for the last therapy (LPM).
• Total Time (h): The total time after the last therapy time (h).
• P90: The pressure for the 90 percent of the last therapy (cmH2O/hPa).
• Version: Software version number used for the device.
• SN: The serial number of device.
AHI
Used Time (h)
Treatment Time (h)
Average Pressure
Average Leakage (Lpm)
0.0
0.0
0.0
0.0
0.0
Info
Picture 1-1: Home Picture 1-2: Information
10.1.2 Setting:
Your device has been set up for your needs by your care provider, but you may nd you want to
make small adjustments to make your therapy more comfortable. Highlight setting and press the dial
to see your current settings. From here, you can personalize your options.
• Wisdom Humidifying: Enable this function, device can moistens the air automatically according
to the environment condition.
• Heated Tube: You can set the heating level between 0 to 5, where 0 means this function is
disabled, 1 is the lowest heating level, and 5 is the highest heating level. The heated tubing is
used to heat the air, so that the treatment will become more comfortable. The heating level of the
heated tubing (0-5 level ) equivalent to the following temperature (accuracy ± 2℃). (The following
temperatures were measured with the humidication off and the wisdom humidication off)
0 : OFF 1 : 18℃2 : 21℃3 : 23℃4 : 25℃5: 28℃
When the heated tubing is properly connected to the device, the therapy page will display the
heating line icon , as shown in the gure:
Therapy 10:06
7.0
cmH2O
3
0
0
SPO2(%)
PR(bpm)
5.0-15.0 ?? APAP
Mode
Pressure
• Sound Reminder : Enable this function, if abnormal air leakage occurs, the device will give a
sound reminder.
• Smart Start/Stop: When this function is enabled, therapy starts automatically when you breathe
into your mask. When you remove your mask, it will stop automatically after 1minute.
• FPS Level: When this function is enabled, you may nd it easier to breathe out. This can help
you get used to therapy. You can set the humidity level between 0 to 3, where 0 means this
function is disabled, 1 is the lowest level of FPS, and 3 is the highest level of FPS. The higher
FPS level means more comfortable expiration you will get.
• Backlight (%): You can set the back light of the screen. The range of setting is 0-100%.
• Date: You can adjust time shown on the screen, include year, month and date.
• Time: You can adjust time shown on the screen, include hour and minute.
• Clock Alarm: Enable this function, you can setting time of clock as well.
• Language: You can choose English or Chinese.
• Filter Remind: Enable this function, this can notice you when to check and change lter.
• Restore Defaults: This function can restore the device parameters to the factory defaults.
Time
Clock Alarm
Language
Filter Reminder
Restore Defaults
10：06
OFF
English
4Week
>>Enter
Picture 2-1：Home Picture 2-2：Setting
10.1.3 Ramp:
Ramp time designed to make you more comfortable at the beginning of the therapy; you can adjust
the ramp time from 0 to 45 minute with an increment of 5min.

09 10
To adjust the ramp:
Highlight the ramp time, and press dial to see your current setting;
Press dial and rotate it to adjust your setting;
Press dial to save your change.
Ramp
45min
Picture 3-1：Home Picture 3-2：Ramp
10.1.4 Humidity level:
The humidifier moistens the air and is designed to make therapy more comfortable. If you are
getting a dry nose or mouth, turn up the humidity. If you are getting any moisture in your mask,
turn down the humidity. You can set the humidity level between 0 to 6, where 0 means disable this
function, 1 means the lowest level of the humidity and 6 represent the highest level of the humidity.
If the humidity level is 1 to 6, it means that the heater plate is heating when the device is running.
The temperature of each level on the heater plate is as following (accuracy is ±4℃)
1 : 33℃2 : 35℃3 : 40℃4 : 45℃5 : 50℃6 : 55℃
This temperature has been tested with empty water tank. The time required (warm-up time) to reach
the set temperature from a starting temperature of (23°C ± 2°C) is 10 minutes.
To adjust the humidity level:
• Highlight the humidity level, press dial enter the humidity page;
• Press the dial and rotate it choose humidity level ,then press dial again to save your change and
back to home page;
• You can change humidity level at any time during therapy.
Humidity
3 Level
Picture 4-1: Home Picture 4-2: humidity
f10.2 Function that patient must be used under the direction of doctor(Clinical menu):
The patient should use the device by the direction of physician.
Mode
Max Pressure
Min Pressure
Initial Pressure
Therapy Pressur
FPS Level
APAP
20.0
15.0
15.0
15.0
2.0
Clinical Menu
Mode
Initial Pressure
Therapy Pressure
Pressure Unit
FPS Level
Ramp (minutes)
CPAP
4.0
10.0
cmH2O
2
30
Clinical Menu
Picture 5-1：Clinical menu (CPAP) Picture 5-2：Clinical menu (APAP)
10.2.1 Set Mode ( CPAP or APAP )
• At home page, press and hold START/STOP button and dial at the same time for three seconds,
the clinical menu will be shown on screen (see picture 5-1).
• Rotate the dial, highlight the “Mode”, and then select CPAP or APAP.
• After mode setting, press dial to save your change.
• Highlight the “Back”, press dial to back to home page.
10.2.2 Set Pressure
• At clinical page, choose “CPAP” mode, Highlight “Initial Pressure” or “Therapy Pressure”, press
and rotate dial to set suitable value.
• You can rotate the dial to the right or to the left to rise or decrease therapy pressure (each step
is 0.5 cmH2O / hPa).
• After setting therapy pressure, press dial to save your change.
• Highlight the “Back”, press dial to back to home page.
• You can set “Max Pressure”, “Min Pressure”, “Therapy Pressure” and “Initial Pressure” of APAP
mode according to above method.
Notice:
When you try to make the Max pressure lower than Min pressure, or Initial pressure, the device will
let these three pressures at same value automatically.
10.2.3 Set Pressure Unit
• At clinical page, highlight “Pressure Unit”.
• Rotate the dial to the right or left, set your pressure unit (cmH2O or hPa).
• After setting pressure unit, highlight the “Back”, press dial to back to home page.
10.2.4 Set FPS Level:
• At clinical page, Highlight “FPS Level”.
• Rotate the dial to the right or left, set your level of FPS (0-3 level).
• After setting level of FPS, highlight the “Back”, press dial to back to home page.
10.2.5 Set Ramp:
• At clinical page, Highlight “Ramp”.
• Rotate the dial to the right or left, set your ramp time (0-45minutes, step value is 5 minutes).
• After setting Ramp, highlight the “Back”, press dial to back to home page.

11 12
10.2.6 Set Humidity Level
• At clinical page, Highlight “Humidity Level”.
• Rotate the dial to the right or left, set your humidity level (0-6level, step value is 1 level).
• After setting humidity level, highlight the “Back”, press dial to back to home page.
10.2.7 Erase Data
• At clinical page, Highlight “Erase Data”.
• Press the dial to the page where you can choose OK or Cancel about erase data.
• If you choose OK, your therapy data will all be erased.
Caution:
During your therapy, you can go to clinical menu by pressing and holding dial and START/STOP
button at the same time for three seconds. Section 10.2 clinical menu tells the method to change all
the parameters.
11. Caring for your device
It is important that you regularly clean your device to make sure you receive optimal therapy. The
following sections will help you with disassembling, cleaning, checking, reassembling your device.
f11.1 Disassembling
2
1
3
5
4
1. Pull the power connector out of device;
2. Press the snap on the heated tubing and gently pull it out of the machine;
3. Hold the water tank at the top and bottom, press it gently and pull it away from the device;
4. Open the water tank and pour out the left water;
5. Hold both the cuff of the heated tubing and the swivel of the mask, then gently pull apart.
Notice: Don't pull the threaded portion of the heated tubing.
f11.2 Cleaning
WARNINGS!
• Regular cleaning of the device and its accessories is very important for the prevention of
respiratory infections.
• To avoid electric shock, always unplug the device before cleaning.
• Use mild soap that is nontoxic to humans.
• Before cleaning, check whether the device has been disconnected from the power supply, whether
the power cord has been unplugged, and whether the water tank of the device has cooled down.
Make sure the plate has cooled down to room temperature, so you do not get burned.
• Do not open or modify the device. There are no user serviceable parts inside. Repairs and
servicing should only be performed by an authorized service agent.
CAUTIONS!
• Overheating of the materials could lead to early fatigue of these materials.
• Do not clean the device with bleach, chlorine, ozone,UV light,aromatic solution, moisturizing
factor, antibacterial soaps, sesame oil, or any other methods outside of this manual.
• Do not immerse the device in any uids.
11.2.1 Cleaning the Water Tank
You can clean the water tank with a soft cloth which does not scratch the water tank (dip the soft
cloth in liquid soap if necessary), rinse it thoroughly, and then wipe it dry with a soft cloth.
WARNINGS!
• Emptying and cleaning the water tank daily will help prevent mold and bacteria growth.
• Allow the water in the chamber to cool down to room temperature before removing it from the
device.
CAUTIONS!
• Clean the water tank only after the water in it cools. Make sure that no water enters the device.
• After cleaning, rinse the water tank throughly in clean water to make sure that no soap residue is
left; then wipe it dry with a lint-free cloth, so as to prevent calcareous accumulations.
• Inspect the water tank for any leak or damage. Replace the water tank if any damage is present.
• It is recommended to do daily cleaning of the water chamber.
11.2.2 Cleaning the Enclosure
Wipe the surface of the device with a soft, slightly damp cloth.
CAUTIONS!
• The device can only be used after the enclosure is dry, so that no moisture enters the device.
• It is recommended to clean the enclosure once a week.

13 14
f11.3 Checking:
You should check power adapter and cable, water tank, heated tubing and air lter regularly in case
of any damage.
a. Check the power adapter and cable
• Wipe the power adapter and cable with the dry compress if it is dirty.
• Replace the power adapter and cable if it is broken.
b. Check the water tank
• Replace the water tank if it is broken or cracked.
• Replace the water tank if the seal is torn or cracked.
c. Check the heated tubing
• Replace the heated tubing if there are any holes, tears or cracks.
d. Check the air lter
• Please check the air lter every week and replace the air lter at least every four weeks.
• If you nd some particle blocked in the air lter, replace it more often.
To replace the air lter
2
1
4
3
1. Open the air lter cover;
2. Remove the dirty air lter;
3. Place a new air lter onto the air lter cover;
4. Close the air lter cover.
Caution:
Make sure the air lter is tted at all times to prevent water and dust from entering the device.
f11.4 Reassembling:
After shed all the cleaning steps, reassemble all these parts together. When the water tank and
heated tubing are dry, you can reassemble the parts.
• Open the water tank and ll it with distilled room temperature water up to the maximum water
level mark.
• Close the water tank and insert it into the side of the device.
• Connect the heated tubing rmly to the air outlet located on the rear of the device.
• Connect the free end of the heated tubing rmly onto the assembled mask.
12. Therapy data
The device records your therapy data for you and your care provider so they can view and make
changes to your therapy if required.
The data is recorded in your therapy device and then transferred to your care provider via a USB
Flash Disk.
USB Flash Disk
USB Connector
1. Open the cover at the left side of the device;
2. After the machine page is transferred to the home page, push the USB Flash Disk into the USB
Connector;
3. Remove the USB Flash Disk from the device after it wrote success.
13. Traveling
You can take your device with you wherever you go. Just keep the following in mind.
• Use the travel bag provided to prevent damage to the device.
• Empty the water tank and pack it separately in the travel bag.
• Make sure you have the appropriate power cord for the region you are traveling to. For
information on purchasing, contact your provider or Yuwell.
14. Trouble shooting
When your device has trouble, look for the following table to nd solution. Contact your physician,
your provider or Yuwell if you cannot solve your problem. Do not try to open the device.

15 16
f14.1 General troubleshooting:
Trouble Cause Solution
Air is leaking from
around my mask.
Mask may be tted incorrectly;
The size of the mask is not
suitable.
Ensure your mask is tted correctly;
See your mask user guide to check your
mask t and seal;
Please refer to the nose measurement
card to choose the appropriate mask size.
I am getting a dry or
blocked nose.
Humidity level may set too low;
For the blocked nose:
History of nasal disease;
The pressure parameter may
be set improperly.
Adjust the humidity level;
Use after treatment by a doctor;
Adjust the pressure parameter.
I am getting droplets
of water on my nose,
in the mask and
heated tubing.
The humidity level may be set
too high;
Condensation forms in the
piping mask due to cold
weather.
Adjust the humidity level;
Open the heated tubing to solve
condensation.
My mouth is very dry
and uncomfortable.
Air may be escape from your
mouth;
The humidity level is not on or
may be set too low.
You may need a chin strap to keep your
mouth closed or a full face mask;
Increase the humidity level.
Air pressure in my
mask seems too
high (it feels like I am
getting too much air).
Ramp may be turned off;
The pressure parameter may
be set too high.
Enable your ramp option;
Decrease the pressure.
Air pressure in my
mask seems too low
(it feels like I am not
getting enough air).
Ramp may be in progress;
The pressure parameter may
be set too low.
Start your therapy after the setting
pressure reached or turn ramp time off;
Increase the pressure.
My screen is black. After therapy start, the screen
backlight went off;
In other case, the power do not
connect rmly.
Press dial to turn on the screen light;
Check the connection of power, ensure it
connect with device rmly.
My water tank is
leaking.
Water tank assemble
incorrectly or it is broken.
Check the water assemble correctly;
Contact your provider or Yuwell if your
water tank is broken.
The heated tubing
does not work.
The heated tubing is not
properly connected;
The function of the heated
tubing is not enabled;
The heated tubing is broken.
Checking the connection of the heated
tubing, when the connection is successful,
the icon will be shown in the therapy
page;
Enable the heated tubing function in the
setting page;
Or contact your provider or Yuwell.
f14.2 Other trouble:
Message in LCD Meaning of error Solution
ERROR 1 There is a mistake of pressure sensor Please contact your provider or Yuwell
ERROR 2 There is a mistake of ow sensor Please repower your device or contact
your provider or Yuwell
ERROR 3 There is a mistake of temperature
sensor
Please contact your provider or Yuwell
ERROR 4 Functional safety detection is abnormal Please contact your provider or Yuwell
ERROR 5 There is a parameter out of the
corresponding range
Please repower the device or contact
your provider or Yuwell
ERROR 6 The pressure is out of range Replace the lter with a new one or
repower the device or contact your
provider or Yuwell
ERROR 7 It is failed to supply power to the
humidier
Please contact your provider or Yuwell
ERROR 8 There is a mistake of blower Please contact your provider or Yuwell
ERROR 9 There is a mistake of RTC ( loss power ) Please adjust the time of the device or
contact your provider or Yuwell
15. Specication of technology
Items Species
Power Input :100-240VAC, 50-60Hz, 2Amax
Output:24V DC, 5A
Heated tubing Power supply connection: 0-24VDC, 2A (max)
Connection port output: 0-24VDC, 2A (max)

17 18
Environment
conditions
Temperature Operate:+5℃~ 35℃(+41℉~ 95℉) Non-
condensing
Transport and storage:-20℃~ 70℃(-4℉~
158℉) Non-condensing
Humidity Operate: relative humidity 15%-90% Non-
condensing
Transport and storage: relative humidity 15%-
90% Non-condensing
Atmospheric pressure range 700 hPa~1060 hPa
Altitude ≤3000 m
Protection class Type of Protection Against Electric Shock: Class Ⅱ
Degree of Protection Against Ingress of Water: IP21 (the device)
IP22 (the Power adapter)
Degree of Protection Against Electric Shock: Type BF Applied Part
Mode of
operation
Continuous operation
Maximum single
fault steady
pressure
Device will shut down in the presence of a single fault if the steady state
pressure exceeds: 40 cmH2O
Sound Sound pressure level Sound pressure level measured according
to ISO 80601-2-70:2015 (CPAP mode) :
28±2 dB (A)
Sound power level Sound power level measured according to
ISO 80601-2-70:2015 (CPAP mode) : 36±2
dB (A)
Physical
properties
Dimensions
(length*width*height)
285 mm*155 mm*125 mm or
11.2'' * 6.1'' * 4.9''
Weight About 1500 g
Heated tubing Plastic hose, about 1.8 m
Maximum volume of
water tank
260 ± 10 mL
Air outlet 22 mm (complies with ISO 5356-1:2015)
Temperature Maximum temperature
of heater plate
55℃ ±4℃ ( 131℉ ±14.4℉ )
Cut-out 110℃(if it is damaged, return to manufacturer)
Maximum gas temperature 43℃
Air lter Material: Polyester non-woven ber
Average arrestance: ≥ 85% for~2.5 micron dust
Therapy pressure 4~20 hPa (adjustable, step is 0.5 hPa) or 4~20 cmH2O
Initial pressure 4~20 hPa (adjustable, step is 0.5 hPa) or 4~20 cmH2O
Maximum
pressure
4~20 hPa (adjustable, step is 0.5 hPa) or 4~20 cmH2O
Minimum
pressure
4~20 hPa (≤ maximum pressure, adjustable, step is 0.5 hPa) or 4~20 cmH2O
Ramp 0~45 minutes (adjustable, step is 5 minutes)
Gas leakage 2 L/min at the maximum rated pressure
Maximum
owrate
The performance of the device at set pressure according to ISO 80601-2-
70:2015 is shown below
Test pressures(hPa) 4 8 12 16 20
Average ow at the PATIENT-
CONNECTION PORT (L/min) ≥100 ≥100 ≥100 ≥100 ≥100
Pneumatic ow path:
Atmosphere Filter Blower Air tube
Flow sensor
Pressure sensor Leak
Mask
Humidier
performance
Humidication system output: ≥ 12 mg/L
(The humidier belongs to Category 2 according to the standard ISO 80601-2-
74:2017)
Relative humidity: ≥ 50%

19 20
Pressure
accuracy
Maximum static pressure variation according to ISO 80601-2- 70:2015
± [2% of the full scale +4% of the set value]
Maximum dynamic pressure variation according to ISO 80601-2-70:2015
Pressure(cmH2O) 10 bpm 15 bpm 20 bpm
4 ± [2% of the full scale +4% of the set value]
8 ± [2% of the full scale +4% of the set value]
12 ± [2% of the full scale +4% of the set value]
16 ± [2% of the full scale +4% of the set value]
20 ± [2% of the full scale +4% of the set value]
Maximum limited
pressure
The maximum limited pressure
20 cmH2O in normal condition
40 cmH2O under single fault Condition
The Uncertainty
of measurement:
For measures of pressure: ± 0.2 hPa
For measures of ow: ± 2 L/min or ± 3% (whichever is greater)
Expected service
life
Device (excluding accessories) 5 years
Water tank 90 days
Heated tubing and mask Refer to the label of the heated tubing and
user manual of the mask
16. Symbols
f16.1 The following symbols may appear on the product or packaging:
Symbol Meaning Symbol Meaning
Follow instructions for use Start therapy / stand-by
Caution Date of manufacture
Manufacturer Type BF applied part
Medical device Model number
Serial number Maximum water level
Prescription only General warning sign
Warning: hot surface Class ii equipment
Use-by date Batch code
Temperature limitation for storage and transport
CN
Country of manufacture (china)
Date of manufacture is on the right side of the symbol or below it.
Symbol for the marking of electrical and electronics devices according to directive
2012/19/EU
Protected against access to hazardous parts with a nger and solid foreign objects
of 12.5 mm in diameter and greater, protected against vertically falling water drops.
Protected against access to hazardous parts with a nger?and solid foreign objects
of 12.5 mm in diameter and greater, protected against vertically falling water drops
when enclosure tilted up to 15 degrees.
f16.2 Disposal statement:
Warning:
Please contact local authorities, your provider or Yuwell to determine the proper method of disposal
of this device.
17. Limited warranty
Yuwell warrants that your device shall be free from defects in material and workmanship from date
of purchase for the period specied below:
Product Warranty period
Water tank 90 days
Power adapter 1 year
Device 2 years
The quality warranty is only available to the initial customer. It is not transferable. Warranty is void on
product sold, or resold, outside the original purchase, repaired by the company without accredited,
and pollution caused by smoking
Your provider or Yuwell has the interpretation about the device’s warranty.

21 22
18. Repairing
18.1. If your device is in trouble, please contact your provider or Yuwell. This device only can be
repaired by the provider who has be authorized.
18.2. The user should follow the instruction of cleaning and safety to guarantee the device can be
used for a long time.
18.3. If you have troubles in setting up, using or maintaining the equipment or meet some
unexpected operation or events, please contact your provider or Yuwell as well. If you want to
know more information about your device, you can visit the website of YUWELL: www.yuyue.
com.cn
19. List of cables
Name Lengths(m)
Cable(AC) 1.5
Cable(DC) 1.2
20. Technical description
The device is intended both for home healthcare environment and professional healthcare facility
environment.
f20.1 Compliance information for Emission test
Emission test Compliance
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class B
Harmonic emissions IEC 61000-3-2 Class A
Voltage uctuations/icker emissions IEC 61000-3-3 Complies
f20.2 Compliance information for Immunity test
Immunity test Compliance level
Electrostatic discharge(ESD) IEC 61000-4-2 ±8kV contact
±15kV air
Electrical fast transient/burst IEC 61000-4-4 ±2kV for power supply lines
Surge IEC 61000-4-5 ±1kV differential mode
Voltage dips, short interruptions and voltage
variations on power supply input lines
IEC 61000-4-11
0 % UT; 0, 5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0 % UT; 1 cycle
and
70 % UT; 25/30 cycles
Single phase: at 0°
0 % UT; 250/300 cycle
Power frequency(50Hz) magnetic eld
IEC 61000-4-8
30A/m
Radiated RF EM elds 10 V/m
80 MHz -2,7 GHz
80 % AM at 1 kHz
Conducted disturbances induced by RF
elds
3 V
0, 15 MHz -80 MHz
6 V in ISM and amateur radio bands between 0, 15
MHz and 80 MHz
80 % AM at 1 kHz
NOTE UTis the a.c mains voltage prior to application of the test level.
Test specications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
Test
frequency Band a) Service a ) Modulationb) Maximum power Distance IMMUNITY
TEST LEVEL
(MHz) (MHz) (W) (m) (V/m)
385380 – 390 TETRA 400
Pulse
modulationb)
18 Hz 1,8 0,3 27
450430 – 470 GMRS 460,
FRS 460
FMc)
±5 kHz deviation
1 kHz sine
2 0,3 28
710
704 – 787 LTE Band 13,
17
Pulse
modulation b)
217 Hz
0,2 0,3 9745
780
810
800 – 960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18Hz
2 0,3 28
870
930

23 24
This limited warranty does not cover:
Any damage caused as a result of improper use, abuse, modification or alteration of the product.
Repairs carried out by any service organization that has not been expressly authorized by Yuwell to
perform such repairs
Any damage caused as accident, Act of God or human factor.
Product which is not involved in Quality warranty sheet.
User sign
Date
Contact Department User
Add.
Diagnose Tel.
BreathCare PAP Warranty card
Model SN
Invoice number purchasing date
Dealer
Feedback Couplet
1 720
1 700 –
1 990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Pulse
modulationb )
217 Hz
2 0,3 28
1 845
1 970
2 450 2 400 –
2 570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulationb )
217 Hz
2 0,3 28
5 240
5 100 –
5 800
WLAN 802.11
a/n
Pulse
modulationb )
217 Hz
0,2 0,3 9
5 500
5 785
NOTE If necessary to achieve the IMMUNITY TEST LEVEL,the distance between the transmitting
antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test
distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it
does not represent actual modulation, it would be worst case.
f20.3 Precautions According to IEC 60601
According to IEC 60601-1-2:2014, the device complies with all applicable electromagnetic
compatibility requirements (EMC) .It may have harmful interference with other devices if you do not
following the instructions. However, there is not certain it has not interference with other devices
if you following the instructions. If it does have interference with other device, you can amend
interference by the following methods.
• Enlarge the distance between this device and other device.
• Connect the two devices with different power socket.
• Ask Yuwell engineer for help.
Essential performance and basic safety testing should be done every two years. If your device
needs to be done, please contact your provider or Yuwell. This device only can be tested by the
provider who has be authorized.
21. Warranty card

25 26
This limited warranty does not cover:
Any damage caused as a result of improper use, abuse, modification or alteration of the product.
Repairs carried out by any service organization that has not been expressly authorized by Yuwell to
perform such repairs
Any damage caused as accident, Act of God or human factor.
Product which is not involved in Quality warranty sheet.
User sign
Date
Contact Department User
Add.
Diagnose Tel.
BreathCare PAP Warranty card
Model SN
Invoice number purchasing date
Dealer
Customer Couplet