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BEYOND ResFree

Positive Airway Pressure


Devices
User Manual

BPAP series

Please read it carefully before using this medical device

H u n a n B e y o n d M e d i c a l Te c h n o l o g y Co.,Ltd.
Statement
This user manual is for Sleep Apnoea Breathing Therapy Equipment
ResFree BPAP series of Hunan Beyond Medical Technology Co., Ltd.
All information contained in this document is owned by Hunan Beyond
Medical Technology Co., Ltd. Unless authorized in writing by Hunan
Beyond Medical Technology, no reproduction in any way or of any parts
of this document is permissible. Without our authorization, no
institutions, companies or individuals shall be allowed to produce, sell
or imitate our products. Infringement of our patent protection scope will
constitute violations and we reserve the right to pursue legal redress and
compensation.
Contents
1. Introduction ........................................................................... 1
1.1 Intended use ................................................................ 1
1.2 Warnings ..................................................................... 1
1.3 Cautions ...................................................................... 2
1.4 Contraindications ........................................................ 3
2. Product Model ....................................................................... 3
3. Package Accessories .............................................................. 5
4. Device Components............................................................... 6
5. Device Symbols ..................................................................... 7
6. Device Operation ................................................................... 7
7. Using the SpO2 Kit ............................................................... 8
8. Parameter Settings ............................................................... 11
8.1 Menu ......................................................................... 11
8.2 Monitor Interface ...................................................... 12
8.3 Wave Interface .......................................................... 13
8.4 Parameter setting interface ........................................ 13
8.5 System Setting Interface ........................................... 18
8.6 Information Setting Interface .................................... 20
8.7 Alarms Interface ........................................................ 21
8.8 Preheat Interface ....................................................... 22
9. Alarm Function .................................................................... 22
10. Cleaning, Disinfection and Maintenances.......................... 25
11Troubleshooting ................................................................... 26
12. Specifications .................................................................... 29
13. Traveling with the Device .................................................. 31
14. Service ............................................................................... 32
15. Technical Support .............................................................. 32
16. Disposal ............................................................................. 32
17. Warranty ............................................................................ 32
18. EMC Requirements ........................................................... 33
1. Introduction
1.1 Intended use
The BEYOND ResFree Bi-level Positive Airway Pressure Devices are designed for
delivery of positive airway pressure to provide non-invasive ventilation for adult
patients snoring and obstructive sleep apnea (OSA) in home or hospital environment.
The Bi-level series are also intended for adult patients with COPD, obesity
hypopnea syndrome (OHS), mild-moderate apnea and respiratory insufficiency in
home or hospital environment.
Through non-invasive ventilation, such as wearing masks, the device provides
Bi-level positive airway pressure on patient’s upper respiratory tract to help patient
breath easily.
Please consult with a licensed health care professional prior to using this device. The
device can only be used after the professional physician gives instructions to patient
and setup the device based on patient’s conditions. Professional physicians should
make sure the patient understands all functions of the device and can operate the
device under instructions.
1.2 Warnings
These instructions are for reference only. They cannot replace the expert medical
guidance from a licensed healthcare professional for the proper use of this device.
You should read through and understand this manual before use.
This device is not intended to be used to provide life support.
The proper operation of this device may be influenced or disturbed if any of the
following conditions exist nearby:
- Electromagnetic fields exceeding 3V/m under the EN/IEC60601-1-2 test
conditions.
- The operation of a high frequency device (diathermy).
- Electric shocks from a defibrillator or a short-wave therapeutic device.
- Radiation (such as, x-ray or CT).
- Electromagnetic field (such as, MRI).
Devices have the potential to allow rebreathing of exhaled air. To reduce the
chance of this possibility occurring, please observe the following precautions:
-Use BEYOND Medical accessories only, such as mask and breathing tube.
- Do not wear the mask for a long time while the device is not in operation.
- Do not block or seal the vent holes in the exhalation port of mask.
If you notice any damage to the device or experience any unusual performance
(such as, harsh sounds or unfamiliar odors), quickly disconnect the power supply,
empty the water tank, and stop using the device. Once the device is turned off,
contact your BEYOND representative or local distributor.
Keep the device dry, the tube and mask smooth.
Parameters of the device should only be adjusted by trained medical professional
according to actual conditions.
If you have any symptoms of discomfort during the use of the device, please
contact your medical professional immediately.
Do not use antistatic or conductive hoses or tubes; Use only breathing circuits
provided by your health care professionals, distributor or manufacturer.
Do not tie or seal the ventage, and do not use tape, seals or other substances to
block the air inlet when using a mask with exhalation hole or a breathing circuit with
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an independent air outlet, which may block fresh air and cause suffocation.
Do not cover the device with any objects during use. Otherwise, it may cause
suffocation.
Do not wear the mask before the device is in use. Otherwise, it will cause
rebreathing of inhaled carbon dioxide. Under certain conditions, rebreathing of
exhaled air over several minutes may cause suffocation.
Do not use the device in the presence of a flammable anaesthetic mixture in
combination with oxygen or air, or in the presence of nitric oxide.
Keep away from toxic or hazardous steam during use.
The plug must be inserted to power in a vertical direction to ensure normal use.
Periodically (weekly recommended) inspect flexible cords, cables, and power
supply devices for damage or abrasion. If damaged, stop using the device and
replace it with a new one.
To avoid electric shock, pull the plug off before cleaning the device.
Maintenance of the device can only be carried out by the professional
maintenance personnel authorized by the Company.
Do not use this device if the room temperature is higher than 35 ℃, otherwise the
temperature of air flow may exceed 43℃, which may cause irritation or damage to
your airway.
Do not use this device in direct sunlight or near heating equipment, which may
increase the air temperature of the output to unsafe levels.
To avoid electrical shock, disconnect the power cord before cleaning. Do not
immerse the device in fluid of any kind.
When using this device, make sure the mask is positioned above the height of the
host unit. Failure to do so may cause any condensed water in the Tube to flow into
the user’s nose, creating the risk of possible suffocation.
Stop using this device and replace it with a new one if the humidifier is damaged.
Do not touch the heater plate after turning the device off. Let the heater plate cool
off before touching.
Be sure that the device is in a place that cannot be accessed or touched by
children, who could be entangled, injured, or strangled by the tube.
If you notice an unexplained change in the operation of the device, if the device
sounds strange or harsh, if the device and (or) its power supply has fallen or has
been misused, if the shell is damaged, or if the liquid flows into the device, do not
continue using the device and contact your healthcare professional.
If necessary, our company provides designated qualified technical maintenance or
other qualified technical personnel with necessary technical materials for
maintenance, such as circuit diagrams, component lists, legends, correction rules,
etc.
1.3 Cautions
Do not operate the device if the ambient temperature is beyond the operating
temperature range. If the device has been exposed to temperatures that is above or
below the range of operating temperature, the temperature of the device should be
set to room temperature before use.
Do not immerse the device in liquid of any kind. Do not let any liquid enter into
the device or into the filter near the air inlet.
The condensate water can damage this device. Make sure that the device returns
to room temperature before use.
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Be sure that the filter is seated properly in the device to ensure normal operation.
Any tar from smoking cigarettes near the device will stop the device from
working properly.
If any liquid splashes onto the heater plate, disconnect the power supply and do
not use it until the plate is completely dried.
Only use distilled or purified water in the water tank. If any other type of liquid
is put in the water tank, it may damage the humidifier and/or device, possibly
endangering the health of the user.
Do not exceed the maximum water level mark on the water tank.
Do not splash the water into the device when filling the water tank.
Do not tilt the device. Keep the device level in order to avoid water flowing
back into the device. If water does get inside the device, disconnect the power
immediately and stop using it.
Danger of explosion and fire can result from wrong battery replacement. The
RTC battery needs to be replaced by another one as same model (CR1220,3V,
38mAh). The RTC battery supports real-time clock working. Battery replacement
shall be completed by the manufacturer
1.4 Contraindications
If you have severe respiratory failure, but without any spontaneous breathing, do
not use the device. If any of the following conditions apply to you, consult your
health care provider before using the device.
Absolute contraindications:
Pneumothorax, mediastinal emphysema; cerebrospinal fluid leak, traumatic brain
injury, or pneumocephalus; shock caused by a variety of conditions before treatment;
active epistaxis; upper gastrointestinal bleeding before treatment; coma or impaired
consciousness making the use of mask during therapy impossible; giant vocal fold
polyp, etc.
Relative contraindications:
Severe coronary heart disease complicated with left ventricular failure, acute otitis
media, excessive respiratory secretions and weak cough, weak spontaneous
breathing, nasal or oral tracheal intubation and tracheotomy, severe nasal congestion
caused by a variety of conditions, lung bullae and allergies to breathing masks, etc.
The following side effects may occur during treatment:
- Dryness of the mouth, nose and throat
- Abdominal bloating
- Ear or sinus discomfort
- Eye irritation
- Skin irritation due to the use of a mask
- Chest discomfort
If you have any negative symptoms or discomfort, please contact your doctor or
supplier immediately.
2. Product Model
Note: R series models’ screen is 5-inch, F series models’ screen is 3.5-inch
Max Pressure
Model Main components Working mode
(cmH2O)

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Host, Humidifier,
R-25A Tube,SpO2 Kit APAP, iAPAP, AutoB
(Optional), WIFI
Host, Humidifier,
Tube,SpO2 Kit
R-25S S, AutoB
(Optional),
WIFI (Optional)
Host, Humidifier,
Tube, SpO2 Kit
R-25T CPAP, S, T, S/T
(Optional),
WIFI (Optional)
Host, Humidifier,
Tube, SpO2 Kit
R-25P CPAP, S, T, S/T, APCV
(Optional),
WIFI (Optional)
Host, Humidifier,
CPAP, S, T, S/T, APCV,
R-25V Tube, SpO2 Kit
VAF-ST, VAF-APCV
(Optional), WIFI
25
Host, Humidifier,
F-25A Tube, SpO2 Kit APAP,iAPAP,AutoB
(Optional), WIFI
Host, Humidifier,
Tube, SpO2 Kit
F-25S S,AutoB
(Optional),
WIFI(Optional)
Host, Humidifier,
Tube, SpO2 Kit
F-25T CPAP, S, T, S/T
(Optional),
WIFI(Optional)
Host, Humidifier,
Tube, SpO2 Kit
F-25P CPAP, S, T, S/T, APCV
(Optional),
WIFI(Optional)
Host, Humidifier,
CPAP, S, T, S/T, APCV,
F-25V Tube, SpO2 Kit
VAF-ST, VAF-APCV
(Optional), WIFI
Host, Humidifier,
CPAP, APAP, iAPAP, S,
R-30A Tube, SpO2 Kit
AutoB
(Optional), WIFI
Host, Humidifier,
Tube, SpO2 Kit
R-30T CPAP, S/T, S, T
(Optional), 30
WIFI(Optional)
Host, Humidifier,
Tube, SpO2 Kit CPAP,AutoB,S,T,S/T,A
R-30P
(Optional), PCV,HF
WIFI(Optional)

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Host, Humidifier,
Tube, SpO2 Kit CPAP, S/T, S, T, APCV,
R-30S
(Optional), APAP, iAPAP, AutoB
WIFI(Optional)
Host, Humidifier, CPAP, S, T, S/T, APCV
R-30V Tube, SpO2 Kit VAF-ST, VAF-APCV,
(Optional), WIFI HF
CPAP, S/T, S, T,
Host, Humidifier,
APCV, VAF-ST,
R-30F Tube, SpO2 Kit
VAF-APCV, AutoB,
(Optional), WIFI
APAP, iAPAP, HF
Host, Humidifier,
CPAP,APAP,iAPAP,S,
F-30A Tube, SpO2 Kit
AutoB
(Optional), WIFI
Host, Humidifier,
Tube, SpO2 Kit
F-30T CPAP, S/T, S, T
(Optional),
WIFI(Optional)
Host, Humidifier,
Tube, SpO2 Kit CPAP,AutoB,S,T,S/T,A
F-30P
(Optional), PCV,HF
WIFI(Optional)
Host, Humidifier,
CPAP,
Tube, SpO2 Kit
F-30S S/T,S,T,APCV,APAP,i
(Optional),
APAP,AutoB
WIFI(Optional)
Host, Humidifier, CPAP, S, T, S/T, APCV
F-30V Tube, SpO2 Kit VAF-ST, VAF-A PCV,
(Optional), WIFI HF
CPAP, S/T, S, T, APCV,
Host, Humidifier,
VAF-ST,
F-30F Tube, SpO2 Kit
VAF-APCV,AutoB,AP
(Optional), WIFI
AP,iAPAP,HF
3. Package Accessories
Articles Quantity Articles Quantity
Host 1 Tube 1
Humidifier Water Tank 1 Air Filter 2
Power cord and Adapter 1 User Manual 1
SD Card 1 Mask 1
Three-way Connector 1 Heated Breathing tube (Optional) 1
Carrying Case 1 SpO2 Kit (Optional) 1

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4. Device Components

1 Mute Pressing this button turns off the voice alarm


2 Knob Can be rotated in either direction or pressed to select.
3 ON/OFF Button Pressing this button to start or stop ventilation.
4 SpO2 Port This is the connection port for the SpO2 Kit
5 SD Card slot This is the port where a SD card is inserted.
6 Air Inlet The air filter is placed in this air inlet port.
5 inches screen for R series machine, and 3.5 inches
7 Display Screen
screen for F series
8 Air Outlet This is the connection port for the tubing.
9 Power Port This is where the cord from the adapter is Connected.
10 Water Tank It can be added with water for humidification.
Heated Tube
11 This the connection port for heated breathing tube.
Connector
The gases delivered from host, entering into water
12 Host gas output
tank for humidification.
Host humidified The humidified and warmed gases outlet delivered
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gas output from water tank.
14 Heating plate It can heat the water tank.
Water tank air
15 It is the outlet of the air in water tank
outlet
Water tank air
16 It is the inlet of the air in water tank
inlet
Do not remove the Knob. The metal rod in the Knob may contact an external
current source, causing damage to the host. If the Knob falls off, you may contact
the dealer or the manufacturer to purchase a new Knob.
In case of button failure, you may contact the dealer or manufacturer for help.

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5. Device Symbols
The symbols below will be shown on the device during operation. Please read the
following carefully before operation.

Symbol Definition
Warnings, cautions
Type BF applied part
Serial number of the product
Date of the product
Follow instructions for use
The authorized EU-representative
Information of manufacture
Turn On/Off
Max water line

Class Ⅱ device

Sound pausing
Degree of Protection Against Ingress of Water And
IP22 Particulates
Conform to the Waste Electrical and Electronic
Equipment /the Restriction of the Use of Certain
Hazardous Substances in Electrical and Electronic
Equipment
High temperature warning

6. Device Operation
1.Place the device on a steady flat table where the settings are easy to reach and the
information on the display can be clearly seen by the user. Maintain at least 5cm (2
inches) between the device and the wall to ensure that the air inlet is not obstructed.
2. When using the device, ensure the surrounding air flows freely and keep the
device away from any heating or cooling devices (air conditioning vents, radiators,
etc.)
3. Place the air filter in the slot at the Air Inlet port.
4. Fill water into water tank: remove water tank from device (refer to picture ①);
open the water tank and then pour pure water into it. Please pay attention that the
water amount shall not exceed the maximum water line (refer to picture ②)

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Notice
It is recommended to replace water in water tank every day.
When adding water to the water tank, do not exceed the maximum water line.
Otherwise, it will increase the risk of water ingress into breathing tube and the host.
5. Put the water tank back into device (refer to picture ③);
6. Connect one end of breathing tubing into Air Outlet (refer to picture ④).

7. Connect the mask into the other end of the tubing (refer to picture ⑤);
8. Connect the power adapter into the Power Port on the rear of the device (refer to
picture ⑥)

9. Connect the device to mains power supply. The device will display the Standby
Interface.
Put the device on a solid flat surface where the approach is not blocked, the
displays are easy to see, and the controls are convenient to access. Be sure to place
the device where it cannot fall easily. The device needs to be lower than the height
of the bed.
Be sure to take preventive measures in order to avoid water damages to the
device.
When water is in the water tank, do not move the device, so as to avoid water
entering into the device.
t
7. Using the SpO2 Kit
7.1 Intended use
The SpO2 Kit is immediately ready to use when it is connected to the main
device via the Communications Port. The SpO2 Kit is intended to be used for
continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate
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monitoring for adults weighting more than 40 kg (90 pounds), which will not change
the intended use of ResFree device.
7.2 Contraindication
When the SpO2 Kit is used together with ResFree device, the contraindications
of the ResFree device will not be changed.
7.3 Description
The SpO2 Kit consists of two parts: SpO2 Probe and Connector.
Always use the SpO2 Kits provided by manufacturer. Unmatched SpO2 Kits may
lead to degradation of device performance.
Attach the SpO2 kit’s Probe to the patient's index finger (although other fingers can
also be used). Please use it under non-exercise state.
The sampling frequency of the SpO2 signal is 1 second, and the update frequency of
the machine is 2 seconds. If the SpO2 Kit is not performing correctly, the option of
SpO2 will be displayed in gray on the Main Interface.
This SpO2 Module has been validated and tested for compliance with ISO
80601-2-61: 2017. The SpO2 accuracy is a root-mean-square difference of less than
3.0% over the range of 70% t0 100% SaO2. (Note: Because pulse oximeter
equipment measurements are statistically distributed, only about two-thirds of pulse
oximeter measurements can be expected to fall within ±Arms of the value measured
by a CO-oximeter.)
Clinical subjects: healthy adults, aged 18~40, gender: natural distribution, skin color
requirements: Not less than 30% of dark-skinned subjects.

Alarm Statement about SpO2 and Pulse Rate


The SpO2 Kit is the auxiliary monitoring equipment of ResFree device which does
not sustain life. Therefore, SpO2 and pulse rate alarm are not provided.
Limitation of Measurement
If you encounter difficulties in detecting signals or obtaining accurate measurement
results, please refer to this section to find the cause.
The measurement depends on the pulsatile characteristics of the blood flow in the
artery. In the following cases, the arterial blood flow may decrease to a level that
cannot be measured:
——Shock
——Low temperature
——Used vasoactive drugs
——Anemia
The measurement also depends on the absorption of special wavelength light by
oxygenated hemoglobin and reduced hemoglobin. If there are other substances
absorbing the same wavelength, it will lead to false or low SpO2 values in the
measurement. For example:
——Hemoglobin carbide
——Methemoglobin
——Methylene blue
——Carmine indigo
Strong light in the surrounding environment will also affect the measurement. The
quality of measurement can be improved by covering the sensor with an appropriate

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opaque substance. At the same time, the probe must avoid external light sources,
such as radiant light or infrared light.
Make sure your nails block the light.
The probe’s cable shall be placed on the back of the hand.

Specifications
Size Host Size: 57*25*15mm

Weight 66g

Normal Working Transportation and Store


Temperature 5℃~35℃ -20℃~55℃
Environment 15%~93% 15%~93%
Humidity
Condition (non-condensing) (non-condensing)
Atmospheric
70~106kPa 70~106kPa
Pressure
Transportation Impact, violent vibration and moisture should be avoided during
Requirements transportation.
Display Range: 35% ~ 100%
Measurement Range and Accuracy: 70% ~ 100%, within±3%,
SpO2 SpO2 range (<70%) is no specified.
Measurement Resolution: 1%
Update frequency: 5HZ
Display Range: 25~250BPM,
Measurement Range and Accuracy: 25 ~ 250BPM, within±3BPM
PR
Measurement Resolution: 1BPM
Update frequency: 5HZ
Wavelength Red light: 660nm, Infrared light: 940nm ±10nm

Maximum
The average value is less than 1.5MW
Optical Output
When the device operates under conditions beyond the scope specified in the
above technical specifications, it may lead to inaccurate measurement or output.
7.4 Safety Warning
Please use the accessories provided by our company. The user should check the
compatibility of the host, SpO2 Kit and other accessories before use. Incompatible
accessories will cause abnormal function or performance reduction.
Wearing SpO2 probe for a long time will cause injury to your finger. It is
recommended to change the probe’s wearing position every 3 hours.
Measurement accuracy may be affected by strong light in the surrounding
environment, excessive movement, intravascular staining, poor finger perfusion,
thick fingers or improper placement.
Polishing nails, fake nails or onychomycosis will cause wrong measurement data.
Patients with low blood pressure, severe systolic blood pressure, severe anemia or
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hypothermia will cause wrong measurement data.
In order to prevent the SpO2 Kit data receiving or transmission failure, it is
forbidden to put computers, televisions, radios near the SpO2 Kit.
The SpO2 Kit can only be used together with the Beyond ResFree series device.
Even if the other nearby instruments meet the electromagnetic emission
requirements of corresponding national standards, they may still interfere the SpO2
Kit when using it.
Using incorrect SpO2 Kit, different peak wavelength ranges of emitted light will
lead to wrong measurement data. Before use, check the compatibility between SpO2
Kit and device, otherwise it may cause harm to patients.
The SpO2 Kit is calibrated to display the functional blood oxygen saturation.
Do not use the blood oxygen module during magnetic resonance imaging (MRI)
scanning
If the patient has adverse reactions such as allergy to the material of the blood
oxygen probe, please stop using the SpO2 Kit immediately.
If one SpO2 Kit is used by multiple people, cleaning and disinfection must be
followed to avoid cross infection.
Do not use the damaged SpO2 Kit.
Do not disassemble the SpO2 Kit. There is no any part that can be repaired by the
user. Repairing and maintenance can only be performed by the device supplier.
Do not expose the SpO2 Kit to environmental conditions beyond the temperature
and humidity conditions specified in this manual.
When the external insulation layer of the connecting cable of the SpO2 Kit is
damaged, it is forbidden to connect with the patient.
The SpO2 Kit cannot be used together with oxidants, such as nitrous oxide.
Please keep SpO2 Kit away from the fire source and heat source.
It is forbidden to immerse the SpO2 in liquid.
When there is accident during normal use, you must stop using the device and
SpO2 Kit. Appropriate emergency and corrective measures should be taken.
When the device is connected with other treatment devices to form ME system, it
shall meet the safety requirements of EN/IEC 60601-1.
The function tester and patient simulator cannot be used for testing the accuracy
of pulse oxygen probe and pulse oxygen monitor. The equipment uses Masinmo’s R
correction curve, so the accuracy of pulse oxygen module can also be determined by
testing this standard curve.
8. Parameter Settings
8.1 Menu
Connect the device to mains power supply with power cord and power adapter
properly. The screen displays the Menu screen will appear as shown in Fig. 8-1
below.

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Fig. 8-1. Menu Interface
8.2 Monitor Interface
Under the menu interface, rotate the “Knob” button to move the cursor to “Monitor”.
Press “Knob” button and the monitoring interface screen will appear on the display
screen, as shown in Fig. 8-2 below. At this interface, select “Quick set” and press
“Knob” button for 3 seconds to adjust parameters of current working mode.

Fig.8-2 Monitor Interface


SpO2 and Pulse Rate are only displayed when the SpO2 Kit (optional parts) is
correctly attached.
Icon Meaning

1 The SD card is inserted.

2 The device is working.

3 The Ramp function has been set.


The humidifier function and preheat function are enabled and
4 humidifier level has been set.
5 The ECO function has been set.

6 The WIFI is connected.


Indicates that the parameter setting interface is locked. After the
device is powered on, it is locked by default. (Unlocking method:
7 in the menu interface, rotate the Knob to make the cursor
focusing on the parameter, press the "knob" key for 3 seconds to
unlock. After unlocking, is displayed.)

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8.3 Wave Interface
Under the menu interface, rotate the “Knob” button, move the cursor to “Wave” and
press it, the Wave interface will be shown as Fig. 8-3. At this interface, select
“Quick set” and press “Knob” button for 3 seconds to adjust parameters of current
working mode.

Fig.8-3 Wave Interface


8.4 Parameter setting interface
Under the menu interface, rotate the "Knob" button to move the cursor onto the
“Parameter Setting” icon, and then press the “Knob” button and hold on for 3
seconds to enter the following interface Fig.8-4 (Di-Di-Di-Di sound can be heard if
interface is unlocked successfully).
Under unlocked parameter setting interface, rotate the “Knob” button to select
parameter to be set. After selection, press the “Knob” button to confirm. After
confirmation, the selected font will turn green, indicating that the parameters can
now be set. As shown in Fig.8-5.
Note: When “ ”appears at the bottom of the interface, there are three
alternative interfaces.

Fig.8-4 Parameter Setting Interface 1 Fig.8-5 Selected Status Screen

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Fig.8-6 Parameter Setting Interface 2 Fig.8-7 Parameter Setting Interface 3

Parameter Range Description Mode


When the Auto ON is set to “ON”,
The device will automatically enter
Auto ON ON/OFF into the Working State when the All mode
user wears the mask and takes 3
breaths under Standby State.
When the Auto OFF is set to “ON”,
the device will automatically enter
into the Standby State within 15
seconds when the user removes the
mask while the device is in the
Working State. When Auto OFF
Auto OFF ON/OFF All mode
function has been turned ON, the
device will automatically enter into
the Standby State whenever the
user’s mask falls off or the tubing
becomes disconnected while the
user is asleep.
CPAP: provides a constant level of
pressure throughout the breathing
cycle.
S: a Bi-Level mode that responds to
both inhalation and exhalation. The
pressure increases as the user inhale
and decreases as the user exhale.
There is no inspiratory pressure if
user do not inhale. IPAP
(Inspiratory Positive Airway
Pressure) and EPAP (Expiratory
CPAP, S, T,
Positive Airway Pressure) are
S/T, APCV,
pre-determined by user’s healthcare
AVF-ST,
Working provider.
AVF-APCV /
Mode T: a Bi-Level mode that the device
,AutoB,AP
controls the timing of inhalation
AP,iAPAP,
and exhalation according to the
HF
preset parameter.
S/T: a Bi-Level mode that responds
to both inhalation and exhalation.
The pressure increases as the user
inhale and decreases as the user
exhale. If no inhalation is detected
within a set time, the device
automatically starts inhalation.
When the device starts inhalation, it
controls the time of inhalation and
automatically decreases the
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Parameter Range Description Mode
pressure for exhalation within a set
time.
APCV: a Bi-Level mode based on
the S/T - the device controls the
time of inhalation and automatically
decreases the pressure for
exhalation within a set time.
AutoB: Based on S mode, the
inspiratory pressure and expiratory
pressure will be automatically
adjusted according to patient's
respiratory conditions.
VAF-ST: The device is operated in
ST mode within the range of setting
respiratory pressure that is suitable
for setting target tidal volume.
VAF-APCV: The device is
operated in APCV mode within the
range of setting respiratory pressure
that is suitable for setting target
tidal volume.
APAP: Pressure will be
automatically adjusted in CPAP
mode based on patient's respiratory
conditions.
iAPAP: Pressure will be
automatically adjusted and then be
fixed at a certain value (TiPressure)
suitable to patient or with the best
effect.
HF: The device is ventilated with
setting flow. (It can only be selected
if the designated model uses the
heating line.)
This setting sets the output pressure
Press 4-20 cmH2O for the device. It can be set in CPAP
increments of 0.5 cmH2O.
4-20 cmH2O The initial air pressure for the CPAP,APAP
Ramp Function in CPAP is equal or S,T,S/T,APCV
4-23 cmH2O
less than the standard air pressure ,AutoB
4-25 cmH2O selected by the user. S,T,S/T,APCV
The initial air pressure for the
Start Press
Ramp Function under S, T, S/T,
APCV, AutoB is equal or less than
4-28 cmH2O the EPAP. AutoB
This parameter can be set in
increments of 0.5 cmH2O.

15
Parameter Range Description Mode
During expirations, the output
pressure is reduced on the basis of
CPAP,iAPAP,
Belex 0-3 level the setting pressure. The more the
APAP
level is elevated, the more the
pressure is reduced.
4-20cmH2O S
S,T,S/T,APCV
Inspiratory Positive Airway
4-25cmH2O ,VAF-ST,VAF
Pressure delivered by device.
IPAP -APCV,AutoB
It can be set in increments of 0.5
S,T,S/T,APCV
cmH2O.
4-30cmH2O ,VAF-ST,VAF
-APCV,AutoB
S,T,S/T,APCV
4-23cmH2O ,VAF-ST,VAF
-APCV,AutoB
Expiratory Positive Airway
Pressure delivered by device. S,T,S/T,APCV
EPAP 4-25cmH2O ,VAF-ST,VAF
It can be set in increments of 0.5
cmH2O. -APCV

4-28cmH2O AutoB
Set the flow rate under HF mode .
Flow 10-60L/min HF
Increment: 5L/min
The maximum output pressure can
Max
4-20cmH2O be set automatically in increments iAPA,APAP
pressure
of 0.5 cmH2O.
The minimum output pressure can
Min
4-20cmH2O be set automatically in increments iAPAP,APAP
pressure
of 0.5 cmH2O.
Sensitivity to inhalation. The device
senses the transition when the user
enters inhaling phase. It allows the
device to synchronize with user’s
S,S/T,APCV,
Auto, inhalation so that the user can
ISens AutoB,VAF-S
1-6 level breathe more comfortably.
T,VAF-APCV
Smaller level indicates higher
sensitivity. Auto means the device
adjusts its sensitivity according to
user’s breathing condition.
Sensitivity to exhalation. The
device senses the transition when
the user enters exhaling phase. It
Auto, 1-6 allows the device to synchronize S,S/T,AutoB,
ESens
level with user’s exhalation so that the VAF-ST
user can breathe more comfortably.
Smaller level indicates higher
sensitivity. Auto means the device
16
Parameter Range Description Mode
adjusts its sensitivity according to
user’s breathing condition.

Time that it takes for the pressure to


rise from exhaling phase to inhaling S,T,S/T,APCV
ISlop 1-6 level
phase. Smaller level indicates ,AutoB
shorter time.
The device outputs an airflow with T,S/T,APCV,
BPM 3-40bpm a set respiratory rate when the user VAF-ST,VAF-
is unable to self-breath. APCV
The device outputs an airflow with T,S/T,APCV,
InspTime 0.5-4s a set respiratory time when the user VAF-ST,VAF-
is unable to self-breath. APCV
When the user starts to inhale, the
Max device outputs an airflow with the
0.5-4s S,S/T,VAF-ST
InspTime maximum respiratory time set for
IPAP
When the user starts to inhale, the
Min device outputs an airflow with the
0.5-4s S,S/T,VAF-ST
InspTime minimum respiratory time set for
IPAP
Auto B: The maximum inspiratory AutoB
pressure can be set according to
user's breathing conditions;
VAF-ST/VAF-APCV: The
4-30 maximum inspiratory pressure can
Max IPAP AutoB,VAF-S
cmH2O be set automatically in order to
T,VAF-APCV
reach the setting target tidal
volume;
This parameter can be set in
increments of 0.5 cmH2O.
4-23cmH2O The minimum expiratory pressure
Min EPAP can be set according to user's AutoB
4-27cmH2O
breathing conditions;
Modify the Maximum Pressure
Support setting according to user's
breathing conditions. The setting is
Max PS 3-8cmH2O AutoB
the maximum difference (pressure
gap) that is permitted between IPAP
and EPAP.
This parameter sets the time it takes
for the air pressure to ramp up to
CPAP,S,T,S/T
Ramp 0-60min the final pressure selected by the
,APCV,AutoB
user (The parameter can set a time
for 60 minutes. Greater level

17
Parameter Range Description Mode
indicates longer ramp time)
Set the Auto Ramp to ON, and the
Ramp will be performed when the
CPAP,APAP,
trigger condition is reached.
Auto Ramp ON/OFF S,T,S/T,APCV
Set the Auto Ramp to OFF, and the
,AutoB
Ramp will be performed when the
machine is turned ON.
The device through the automatic
VAF-ST,VAF-
VT 200-2000ml pressure adjustment to ensure tidal
APCV
volume achieve the set value.
IPAP and EPAP will not be
changed under AutoB during a
period of time when the function is
OFF/ on. IPAP and EPAP will be
Split Night 120min,180 adjusted to a certain level suited to AutoB
min,240min patient’s respiratory events under
AutoB when the operating time
reaches the setting value of Split
Night.
6-25cmH2O The minimum inspiratory pressure
can be set automatically in order to
VAF-ST,VAF-
Min IPAP reach the setting target tidal volume
6-30cmH2O APCV
This parameter can be set in
increments of 0.5 cmH2O.
indicates the parameter can be set only after unlocking the
Remarks parameter setting interface. Unlocking method: in the menu interface,
rotate the Knob to make the cursor focusing on the parameter, press
the "knob" key for 3 seconds to unlock.)
8.5 System Setting Interface
Rotate the "Knob" button so that the cursor on the Menu Interface screen is pointing
at the "System", then press the "Knob" button to enter into the System Setup
Interface screen, as shown in Fig.8-8.

Fig.8-8 System Setting Interface Screen 1

18
Fig.8-9 System Setting Interface Screen 2

Fig.8-10 System Setting Interface Screen 3

Parameter Setup range Description


19mm tube, It sets different types of tube. User shall set according to
Tube Set
19mm heated tube actual usage.
Nasal mask,
It sets different types of masks. User shall set according
Mask Set Full face mask,
to actual usage.
Nasal pillow
After wearing mask, user can test if the wearing
Mask Fit
condition is suitable for therapy.
ECO Set OFF/ON It turns ON/OFF ECO function.
This parameter sets the device’s internal calendar to
track the date. This date will then be used to record the
Date YYYY-MM-DD
application information for users. This setting needs to
be checked frequently to ensure continued accuracy.
This parameter sets the device’s internal clock to track
the time. This time will then be used to record the
Time H-M-S
application information for users. This setting needs to
be checked frequently to ensure continued accuracy.
This parameter sets the length of time that the LCD
BackLight ON, 30-600 sec display will be back lit. When the user sets a value, the
backlight will turn off after the set time elapses.
This parameter has a five-level range. The higher the
level, the greater the screen brightness. The brightness
Brightness Auto, 1-5 level
will be adjusted automatically according to actual
conditions.

19
Chinese-
Language Can be switched between English to Chinese.
English
Pressure Displayed values can be switched between “cmH2O”
cmH2O-hPa
Unit and “hPa”, as desired by the user.
WIFI
OFF/ON It sets WIFI functions
Settings
Display the currently available WIFI information, select
WIFI the WIFI to be connected and press the dial to pop up
Selection the keyboard, and enter the correct password and pop up
the WIFI connection option.
System Restore will return all system parameters back to
Reset ------
the factory default values.
Version Display the current software version number
SN Display the S/N of the device.
8.6 Information Setting Interface
Rotate the "Knob" button so that the cursor on the Menu Interface screen is pointing
at the "Information", then press the "Knob" button to enter into the Information
Setting Interface screen, as shown in Fig.8-11.

Fig.8-11 Information setting interface screen 1

Fig.8-12 Information setting interface screen 2

Parameter Setup Range Description

1day/7days/30 The time period over which the following


days/3month/ information items are calculated.
UseCycle
6month/12mo The time within 30: Unit is "day";
nth The time beyond 30: Unit is “month”
The length of time that the device has been
UseTime ------ connected to the power supply during preset
UseCycle. Unit is “hour”.
20
The average output pressure value of the
AvgPress ------ device in the running state within the period
of preset UseCycle. Unit is “cmH2O”.
The 95% output pressure value of the device
in the running state within the UseCycle,
TiPressure ------
measured by usage time. Unit is “cmH2O”.
Only for AutoB, iAPAP and APAP mode.
The average leakage value of the device in
AvgLeakage ------ the running state within the UseCycle. Unit
is “L/min”.
Apnea-hypopnea index of the device with
AHI ------ the UseCycle. Calculation method as
Apnea-hypopnea frequency per hour
The device is connected to the power supply
UseDays ------ and continuously running for 4 hours or
more as 1 day.
The duration of running time after the device
RunHrs ------ is shipped from factory. This value cannot
be cleared.
8.7 Alarms Interface
Rotate the "Knob" button so that the cursor on the Menu Interface screen is pointing
at the "Alarm", then press the "Knob" button to enter into the Alarms Interface
screen, as shown in Fig.8-13.

Fig.8-13 Alarm Interface Setting

Parameter Setup Range Description


OFF/8.0-24.0 It sets the upper limit pressure for the
High press
cmH2O device. Increment: 0.5 cmH2O.
OFF/3.0-7.0 It sets the lower limit pressure for the
Low press
cmH2O device. Increment: 0.5 cmH2O.
High It turns on or off the leakage prompt
ON/OFF
Leakage function for the device.
It sets the lower limit for volume per minute
Low MV OFF/1-30L
value. Increment: ±1 L.
The apnea alarm occurs when the apnea
Apnea OFF/10-50s
time exceeds the set value.

21
OFF,1month,
Replace It turns on or off the Replace Filter prompt
3months,6mo
Filter function.
nths,12months
OFF,1month,
Replace It turns on or off the Replace Mask prompt
3months,6mo
Mask function.
nths,12months
OFF,1month,
Replace It turns on or off the Replace Tube prompt
3months,6mo
Tube function.
nths,12months
8.8 Preheat Interface
Rotate the "Knob" button so that the cursor on the Menu Interface screen is pointing
at the "Preheat", then press the "Knob" button to enter into the PreheatInterface
screen, as shown in Fig.8-14.

Fig.8-14 Preheat interface


Parameter Setup Range Description
It turns on or turn off the warm-up
Preheat OFF/ON
function.
It sets the preheat time for the device.
Preheat Time 10-30 minutes
Increment: 10minute.
This parameter sets the output air
humidity level for the device. The higher
the value, the higher the humidity.
Humidifier 0-5 level
"0" indicates that the humidifier is off.
The default value before dispatched from
the manufacturer is “0”.
It sets the temperature of air outlet.
Tube Temp 16℃-30℃ The air outlet temperature is greater than
the set temperature.
Note: The time needed for reaching the set preheat temperature from initial
temperature 23±2℃ should be longer than the set preheat time.
9. Alarm Function
9.1 Alarm Expression
When occurring abnormal working conditions, the device will automatically
generate an alarm to notify the user to make corresponding adjustments to prevent
adverse effects on the patient and ensure normal treatment and safe use of the
device.
There are two types of alarm: high-priority alarm and voice prompt notification to
22
distinguish different alarming conditions. The operator should respond to alarm
immediately as soon as alarm sound is generated.
At the same time, when the device is in on alarm, the ambient light around the
button and knob will turn into flashing red with a flashing frequency of about 2HZ.
Operator position: the operator is expected to be 1 meter away from the device
display screen.
There are two types of high priority alarm:
(1) There are obvious alarming ICONS and text prompts on the interface,
accompanied by Di-Di-Di--- Di-Di sound alarm.
(2) If power supply suddenly failed while device is running, “Di” sound will be
heard for a long time. This is only applied for power failure alarm.
There is one type of prompt:
When the device generates a prompt, a notification writing prompt contents is
displayed with no sound.
9.2 Alarm List
Alarm/P
Setting Range/Alarm Conditions Notification Priority
rompt
If the power supply is
Power disconnected while the device in
None High
failure the Working State, the device will
generate alarming signals.
OFF/8-24cmH2O
When the device’s output pressure
High
exceeds the HighPress setting High pressure!!! High
pressure
value for 5 seconds, the device
will generate alarming signals.
OFF/3-7cmH2O.
When the device’s output
Low pressure is below the LowPress
Low pressure!!! High
pressure setting value for 5 seconds, the
device will generate alarming
signals.
When the device detects that the
adapter output voltage is below
Low
22V±0.5V for 3 seconds, the Low voltage!!! High
voltage
device will generate alarming
signals.
When the gas pathway is blocked
Airway
for over 5 seconds, the device will Airway block!!! High
block
generate alarming signals.
OFF/ON
When there is a leak in the
High
device's breathing tube for over 5 High leakage!!! High
leakage
seconds, the device will generate
alarming signals.

23
Alarm/P
Setting Range/Alarm Conditions Notification Priority
rompt
OFF/1-30L/min
When the device detects that the
Low MV MV is below the LowMV setting Low MV!!! High
value for 5 seconds, it will
generate alarming signals.
When the temperature change is
Humidifi less than ±0.5℃ for 110 Humidifier
High
er Failure seconds, the device will generate Failure!!!
alarming signals.
If fan stop working for 3 seconds
Motor when the device is in the Working
Motor Failure!!! High
Failure State, the device will generate
alarming signals.
OFF/10-50 seconds
When the apnea time detected by
the device is longer than the
Apnea High
setting value for 1 second, the Apnea!!!
device will generate alarming
signals.
When the SD card that has been
SD Card inserted into the device reaches Insufficient SD
Prompt
Full 95% of its capacity limit, the card capacity!
device will provide a prompt.
When the patient uses the air filter
Replace Please replace the
exceeding the setting time, the Prompt
Air Filter filter!
device will provide a prompt.
When the patient uses the mask
Replace Please replace the
exceeding the setting time, the Prompt
Mask mask!
device will provide a prompt.
When the patient uses the tube
Replace Please replace the
exceeding the setting time, the Prompt
Tube tube!
device will provide a prompt.
9.3 Alarm Reset
1.After occurring a high priority alarm condition, timely take remedy measures to
solve problem in order to terminate alarm signal, including sound and text
notification and the red flashing atmosphere light. If intended to postpone remedy,
you press MUTE button to pause the alarming signals for 120 seconds. Under the
condition, sound and text notification will be terminated but red flashing light will
not be changed. After 120 seconds, the alarm system will reset to previous state.
2.When multiple alarms conditions occur at the same time, all warning texts will
appear on the display screen and broadcast in a loop. They will disappear only until
all alarm conditions are remedied.
3.If another new alarm is generated while an alarm is still paused, the audible and
visual alarm signals will be activated to remind user of new and old alarms. Press
MUTE button to pause alarm signals again.

24
9.4 Alarm Remedy
Prompt Remedy

Alarm sound only Power on device again

1.Lower the airway pressure below the setting value of high


High pressure!!! pressure alarm
2.Adjust the setting value of high pressure alarm
1.Turn up the airway pressure beyond the setting value of low
Low pressure!!! pressure alarm
2.Adjust the setting value of low pressure alarm
Low voltage!!! Contact your maintenance staff
Airway block!!! Check and clean breathing tube to ensure the tube is not blocked
High leakage!!! Check breathing tube to ensure no leakage in tube
1.Turn up the minute value beyond the setting value of low MV
Low MV!!! alarm
2.Adjust the setting value of low MV alarm
HUMI
Contact your maintenance staff
FAILURE!!!
Motor Failure!!! Contact your maintenance staff
1.Adjust the airway pressure to reduce apnoea
Apnoea!!!
2.Adjust the setting value of apnoea alarm
Insufficient SD
Remove the SD card, back up data, and delete SD card data
card capacity!
Please replace the
Replace the air filter and then press the knob to confirm
filter!
Please replace the
Replace the mask and then press the knob to confirm
mask!
Please replace the
Replace the tube and then press the knob to confirm
tube!
10. Cleaning, Disinfection and Maintenances
10.1 Timing between Cleanings
Based hygienic reasons, under normal usage, we recommend that the operator or
user replace the parts as below list:
●Clean the device, tube and filter before the device is used for the first time.
●Empty the water tank and clean it daily to prevent bacterial growth.
●Clean the air filter at least once a week and replace the air filter with a new filter
every 6 months.
●Calibrate and conduct functional verification (if necessary) every six months
including pressure and flow calibration.
●Replace the mask with a new one every 6 to 12 months.
10.2 Cleaning
10.2.1 Cleaning the host and tube
To avoid the possibility of electrical shocks and damage to the electrical system,

25
unplug the power cord from the host unit before cleaning or maintaining the device.
Clean the front panel and the outside of the case with a soft cloth that has been
moistened with warm water or mild detergent. Before plugging in the power cord,
make sure that the device is completely dry.
Warning:
1.If the device is used by multiple users, the tubing and mask must be replaced
between each use by a different user.
2.When cleaning the tubing and mask, please refer to the Tubing User Manual and
Mask User Manual.
10.2.2Cleaning the water tank
Remove the water tank, open the upper lid, and clean the internal walls of the
humidifier unit. Clean and rinse the water tank thoroughly.
Use mild liquid detergent to clean the unit and the tank, then rinse them with clean
water. After cleaning, wipe it clean and allow to dry naturally.
Please ensure that the water chamber seals tightly after each cleaning.
10.2.3Cleaning and replacing the air filter
Clean the air filter thoroughly with warm water and mild detergent, then rinse off all
detergent residues thoroughly with clean water. Before reinstalling the air filter, let it
air dry completely. If air filter is damaged in any way, please replace it with a new
filter provided by authorized dealer.
1. Disconnect the device from the power source.
2. Remove the air filter enclosure from the device and remove the air filter.
3. Examine the air filter closely to ensure that it is clean and undamaged.
4. Wash the air filter in warm water with mild detergent. Rinse thoroughly to
remove detergent residue. Allow the air filter to air dry completely before
re-installing. If the air filter is damaged, please replace it with a new one.
5. Reinstall the air filter
Warning: Never install a wet air filter into the device. Users should alternate
between the two air filters included with the device package. This will ensure the air
filter has the chance to sufficiently dry after each cleaning and before it is used in
the device.
10.3 Transportation and storage
10.3.1 Storage
The packed device should be stored in a clean room with good ventilation, at
temperature of -20°C to 55°C, a relative humidity of 15% to 93%
(non-condensing), and with no corrosive gas.
10.3.2 Transportation
After the device being packed into carton, it can be transported in ordinary ways. In
transportation, the device should keep away from moisture, sun and avoid collision.
11Troubleshooting
The table below lists common problems you may have with the device and
provides possible solutions to those problems. If these measures are not effective for
these problems, please contact your home care provider directly.

26
Phenomenon Possible Causes Troubleshooting
Nothing displays on The power supply is not Disconnect the power plug and
the screen or the connected properly. re-connect it.
menu interface not
come on after
turning the device
on
The device beeps The power supply is not Disconnect the power plug and
after turning on. well connected. re-connect it.

The device fails to “Auto OFF” function is Set the “Auto OFF” function to
stop automatically off. “ON”.
after removing the
mask.
Nose and throat are The air is dry in the room. Turn up the humidifier level or
dry or irritated consult the doctor.
when using this
device.
Nose becomes cold. Room temperature may Increase the room temperature.
be too low.
Likely because the patient
sleeps with his or her
The setting pressure may be too
mouth opened so that the
Dry mouth and low.
pressurized air go through
throat. You may also consult your
the mouth, which leads to
doctor.
dryness of the nasal
passages and throat.
Adjust the mask position and
The model or size of the
the headgear’s tightness.
mask may not be suitable.
Eye irritation or Consult your doctor whether
The mask may also be
dryness. you need to replace the mask.
positioned incorrectly
If the mask is old or broken,
causing air to blow into
replace immediately.
the patient’s eyes
Try another mask model.
The headgear is too tight.
The mask model or size
Loosen the headgear and insure
Face reddening or are not suitable.
proper fit.
inflamed. The customer is allergic
Consult your doctor.
to the materials of the
mask.
Lower the humidifier setting or
Room temperature is too
increase the room temperature.
low or humidifier is used,
Place a towel or blanket over
Water in the mask which leads to the output
the tube to maintain the
air condensing in the
temperature of the output air
tube.
flow.

27
Phenomenon Possible Causes Troubleshooting
Stop using.
Nasal, sinus, or ear Inflammation in sinus or
Contact your doctor
pain middle ear.
immediately.
Obstructive Sleep The required treatment
Apnea Hypopnea pressure may be changed
Syndrome due to your weight, nasal Consult your doctor.
recrudesce. (e.g. obstruction, drinking or
daytime sleepiness) some other reasons.
The air filter is either
clogged with dirt or the Replace the air filter.
air inlet is otherwise Check and clean the air inlet.
blocked. The device Place the device in a position
Air output is
might also be too closed with good ventilation which is
abnormally hot.
to wall, curtains or other at least 20 centimeters away
obstructions to block the from the wall, curtains or other
air flow around the objects.
device.
Device malfunction
There is water ingress Contact your device supplier.
No airflow output
onto pressure sampling Dry the pressure sampling tube.
tube.
If the “Ramp” function is
on, it takes time for air
flow to rise from the Turn off or change the settings
The air flow output
initial pressure to the of the Ramp feature.
is too low
treatment pressure. Check and clean the air inlet.
The air inlet may be
blocked.
The blower is
Pressure sampling tube is Check the pressure sampling
always at an
not connected or blocked. tube.
abnormally high
The device is leaking air. Contact your device supplier.
rotation rate.
The device doesn’t
work when it is Device malfunction. Contact your device supplier
turned on.
The device works,
but the pressure in
Check to see if the tubing is
the mask is Tube leakage.
connected properly.
obviously different Device malfunction.
Contact your device supplier.
from the setting
pressure.

28
Phenomenon Possible Causes Troubleshooting
The air filter or air inlet is
blocked.
The treatment pressure Replace the air filter, clean the
has been re-adjusted. air inlet.
The device can
When the “Ramp” Consult your doctor.
only output air at
function is turned on, it If necessary, you may also need
low pressure.
will take times for air to turn off or change the setting
flow to rise from the of the “Ramp” function.
initial pressure to the
treatment pressure.
The tube isn’t connected
Reconnect the Tube properly.
The device is properly or even hasn’t
Ensure there are no leaks in the
excessively loud. been connected.
Tube
The mask or Tube leaks.
The pressure can’t Turn off the Ramp feature, then
The Ramp feature is on.
be set. re-set the pressure.
Turn off the Ramp feature, then
Ramp can’t be set The Ramp feature is on.
re-set the pressure.
If the problem can’t be eliminated immediately by the above suggestions, please
contact your device supplier for repair.
To avoid more injuries or faults, please don’t use the device when any of these
problems persist.
Only professionals certified by BEYOND Medical are authorized to open the
device.
12. Specifications
12.1 Environmental
Parameters Operating Storage
Temperature 5℃ to 35℃ (41˚F to 95˚F) -20℃ to 55℃ (-13˚F to 158˚F)
Humidity 15% to 93% (no condensation) 15% to 93% (no condensation)
Atmospheric
700 to 1060 hPa 700 to 1060 hPa
Pressure
12.2 Physical
Dimensions 243mm*181mm*110mm
Weight 1370g
12.3 Electrical
Input: AC100-240V, 50/60Hz,
Power adapter 1.8Amax
Output: DC24V, 3.33A
Type of protection Against Electric Shock Class II Equipment
Degree of protection Against Electric Shock Type BF applied part
Degree of protection Against Ingress of Water IP22
Mode of operation Continuous
Applied part SpO2 Probe, Tubing, Mask

29
12.4 Noise level
The A-weighted sound pressure level not exceed 30dBA, the A-weighted sound
power level not exceed 38dBA, when the device is working at the pressure of
10cmH2O.
12.5 Pressure Accuracy
According to the pressure accuracy of ISO 80601-2-70:2015 standard.
Pressure Range:
CPAP:4 to 20 cmH2O (in 0.5 cmH2O increments), ≤ 30 cmH2O under single fault
conditions.
BIPAP:
IPAP: 4 to 30 cmH2O (in 0.5 cmH2O increments),
EPAP: 4 to 25cmH2O (in 0.5 cmH2O increments), the maximum reference value for
each model.
≤ 40 cmH2O under single fault conditions.
Pressure display accuracy: ±(0.5 cmH2O +4% of the actual reading)
Pressure stability:
CPAP
Static Dynamic (4 to 20 cmH2O)
±0.5cmH2O ≤ 2cmH2O
BIPAP
Static Dynamic (4 to 30 cmH2O)
±0.5cmH2O ≤ 2cmH2O
12.6 Maximum Flow
According to the maximum flow of ISO 80601-2-70:2015 Standard
CPAP
Test pressure (cmH2O)
4 8 12 16 20
Average flow at the patient
101 101 103 97 79
connection port (l/min)
BIPAP
Test pressure (cmH2O)
4 11 17 24 30
Average flow at the patient
102 103 103 104 91
connection port (l/min)
Note: all test data were carried out under conditions with the humidifier and 22mm
tube.
12.7 Ramp
The ramp time ranges from 0 to 60 minutes.
12.8 SpO2
Range: 0~ 100%.
The margin of error for SpO2 between 70% and 100% is±3%. No strict accuracy
requirements for SpO2below 70%.
12.9 Pulse Rate
Range: 25~ 250 BPM
30
Margin of Error: ±3%
12.10 Tubing
Length: 1.8m
The Form and the Dimensions of the Patient Connection Port
The 22 mm conical air outlet complies with ISO 5356-1.
12.11 Filter
Dimension :36mm*24mm*3.5mm
12.12 Humidifier
Tested according to EN ISO ISO80601-2-74 standard or equivalent methods.
Output air flow
<40℃
temperature:
Not less than 12mg/L
Humidity output measured conditions: Max flow,35℃, 15%
relative humidity.
Pressure drop caused by
<1cmH2O (with the flow rate of 60LPM)
humidifier
Leaking under maximum
<25mL/min(Together with the tubing)
working pressure:
Adaptability <20mL/kPa (Together with the tubing)
capacity 250ml
12.13 Pneumatic Diagram

13. Traveling with the Device


1.Use the Beyond carrying case to carry the device and accessories along with you.
Do not put them in your checked baggage.
2.This device operates on power supplies of 100 ~ 240 V and 50 / 60 Hz, and is
suitable for use in any country in the world. No special adjustment is necessary, but
you will need to find out the types of power sockets at your destination. Bring, if
necessary, a power socket adaptor which can be bought in electronics stores.
3.Security Stations:For convenience at security stations, there is a note on the
bottom of the device stating that it is medical equipment. It may be helpful to bring
this manual along with you to help security personnel understand the device.
Empty the water tank of the humidifier before packing the device for your trip; in
order to prevent any remaining water from entering the device.

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Using the device at an incorrect elevation setting could result in airflow pressures
higher than the prescribed setting. Always verify the elevation setting when traveling
or relocating.
If the device is used when the atmospheric pressure is out of the stated range (See
Section 9), the accuracy of the leakage alert will be affected.
14. Service
The device does not require routine technical servicing.
If you notice any unexplained changes in the performance of the device, if it is
making unusual or harsh sounds, if it has been dropped or mishandled, if the
enclosure is broken, or if water has entered the enclosure, discontinue use. Contact
your health care provider.
If the device malfunctions, contact your health care provider immediately. Never
attempt to open the enclosure of the device. Repairs and adjustments must be
performed by Beyond-authorized service personnel only. Unauthorized service could
cause injury, invalidate the warranty, or result in costly damage.
If necessary, contact your local authorized dealer or Beyond Medical Co., Ltd.,
for technical support and documents.

15. Technical Support


Please contact Beyond directly if you need the circuit diagram of the device and the
list of components for certain purposes such as maintenance or connection to other
equipment. Beyond will provide the circuit diagram and / or other technical
documents in whole or in part according to your needs.

16. Disposal
When the device reaches the end of its service life, dispose of the device and
packaging in accordance with local laws and regulations.

17. Warranty
From the date of purchase, we provide one year warranty for the host, 3 months
warranty for the tubing, mask and humidifier.
We do not undertake to indemnify against losses caused due to user misuse, abuse or
accidents.
Device damage due to water caused by user’s misuse is not covered under warranty.
Disassembling the host without the manufacturer’s permission is deemed to void the
warranty.
Considering the life of components and safety factors, medical devices should not be
used longer than 5 years. Expired products should be discarded according to
corresponding regulations.

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18. EMC Requirements
Guidance and manufacturer's declaration - electromagnetic emissions– this
device is intended for use in the electromagnetic environment specified below. The
user of the device should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment-guidance
The device uses RF energy only for its internal
RF emissions function. Therefore its RF emissions are very low and
Group 1
CISPR11 are not likely to cause any interference in nearby
electronic equipment
RF emissions
Class B
CISPR11 This device is suitable for use in all establishments
Harmonic emissions including domestic establishments and those directly
Class A
IEC61000-3-2 connected to the public low-voltage power supply
Voltage fluctuation network that supplies buildings used for domestic
/flicker emissions Complies purposes
IEC61000-3-3

Guidance and manufacturer's declaration - electromagnetic immunity – this


device is intended for use in the electromagnetic environment specified below. The
user of the device should make sure that it is used in such an environment .
IEC60601 Electromagnetic
Immunity test Compliance level
test level environment-guidance
Floor should be wood, concrete or
Electrostatic
ceramic tile. If floors are covered
discharge ±6KV contact ±6KV contact
with synthetic material, the
(ESD) ±8KV air ±8KV air
relative humidity should be at
IEC61000-4-2
least 30%.
±2KV for ±2KV for
Electrical fast The mains power supply should
power supply lines Mains power line
transient /pulse be the power used in a typical
±1KV for ±1KV for
IEC61000-4-4 home or hospital.
input/output line input/output lines
±1K ±1KV
The mains power supply should
Surge differential mode differential mode
be the power used in a typical
IEC61000-4-5 ±2KV ±2KV
home or hospital.
common mode common mode
<5% UT <5% UT
(>95% dip in UT), (>95% dip in UT),
The mains power supply should
for 0.5 cycle for 0.5 cycle
Voltage dips, be the power used in a typical
40% UT 40% UT
short home or hospital. If the device
(60% dip in UT), (60% dip in UT),
interruptions and user needs to continue to use the
for 5 cycles for 5 cycles
voltage device when the mains power
70% UT 70% UT
variations of the supply is interrupted, it is
(30% dip in UT) (30% dip in UT)
input power recommended to use an
for 25 cycles for 25 cycles
IEC61000-4-11 un-interruptible power supply or
<5% UT <5% UT
battery to power the device.
(>95% dip in UT) (>95% dip in UT)
for 5 s for 5 s
Power frequency Power frequency magnetic fields
(50/60Hz) shall be at levels characteristic of
3A/m 3A/m
magnetic field a typical location in a typical
IEC61000-4-8 hospital or home environment.
Note: UT is the a.c. mains voltage prior to application of the test level.

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Guidance and manufacturer's declaration - electromagnetic immunity – this
device is intended for use in the electromagnetic environment specified below. The
user of the device should make sure that it is used in such an environment.
IEC60601 Compliance
Immunity test Electromagnetic environment-guidance
test level level
Portable and mobile RF communications
equipment should be used no closer to any part
of the device, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance

3Vrms d = 1.2 150 kHz ~ 80 MHz


Conducted RF 150kHz to d = 1.2 80MHz to 800MHz
3Vrms
IEC61000-4-6 80MHz
d = 2.3 800MHz to 2.5GHz
Radiated RF 3V/m
3V/m is the maximum normal output power of the
IEC61000-4-3 80MHz to
transmitter,its unit is Watt (W) and d is the
2.5GHz
recommended separation distance,its unit is
meter (m).
Measured magnetic field strengths a from fixed
RF transmitter should be less than the
compliance level in each frequency range b .
Interference may occur in the vicinity of
equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applied.
Note 2: These guidelines may not be applied in all situations. Electromagnetic propagation is
affected by absorption and reflection of the structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the device is used exceeds the applicable RF compliance level
above, the device should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, the field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF


communications equipment and the device: The device is intended for use in an
electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the device can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the device as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum separation distances according to different frequency of transmitter
output of
transmitter 150 kHz ~ 80 MHz 80 MHz ~ 800 MHz 800 MHz ~ 2.5 GHz
(W) d = 1.2 d = 1.2 d = 2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
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100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters(m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts(W) according to
the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applied.
Note 2: These guidelines may not be applied in all situations. Electromagnetic propagation is
affected by absorption and reflection of the structures, objects and people.

Manufacturer
Hunan Beyond Medical Technology Co., Ltd.
Add: Lijiacun Rd, Xueshi Street, Yuelu District, Changsha, Hunan, China.
Tel: +86-731-82564299
www.csbeyond.com

VersionNo.: BE/20220622/A1

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