Byond ResPlus C-20A CPAP User manual
BEYOND ResPlus C-20A CPAP
User Manual
Please read this manual carefully before using this product
User Manual
The following document is the User Manual for the BEYOND
ResPlus C-20A CPAP (“C-20A CPAP” or “the device”)
manufactured by Hunan Beyond Medical Technology Co., Ltd.
(hereafter, called “BEYOND Medical”).
All the information contained in this document is the legal property
of BEYOND Medical and, unless specifically authorized in advanced
and in writing by BEYOND Medical, the material contained in this
document must not be reproduced in any means. Without a written
authorization from BEYOND Medical, no institutions, companies, or
individuals have the right to produce, sell, duplicate, or imitate the
products contained herein. Doing so constitutes an infringement of
the scope of our patent protections and constitutes a violation of the
U.S. law.
BEYOND Medical reserves the right to pursue legal remedies
against all such violations.
Contents
1. Introduction..........................................................................................1
1.1 Intended use..............................................................................1
1.2 Warnings...................................................................................1
1.3 Cautions....................................................................................2
1.4 Contraindications......................................................................3
2. Model...................................................................................................4
3. Package Contents.................................................................................4
4. Device Components.............................................................................4
5. Device Symbols...................................................................................5
6. Device Operation.................................................................................6
6.1 First Use....................................................................................6
6.2 Daily Use..................................................................................6
7. Humidifier............................................................................................7
7.1 Humidifier Composition...........................................................7
7.2 Humidifier Connection & Separation with the Host Unit.........8
8. Using the SpO2 Kit..............................................................................9
9. Parameter settings..............................................................................10
9.1 Main Interface Screens ...........................................................10
9.2 PFCurve interface...................................................................11
9.3 Parameter Setting Interface.....................................................11
9.4 System Setting Interface.........................................................13
9.5 Information Setting Interface..................................................15
9.6 Epworth Interface ...................................................................16
10. Prompt..............................................................................................18
11. Cleaning, Disinfection and Maintenances........................................18
11.1 Timing between Cleanings ...................................................18
11.2 Cleaning................................................................................19
11.3 Disinfection...........................................................................19
11.4 Transferring to Another User................................................19
12. Troubleshooting...............................................................................20
13. Specifications...................................................................................22
14. Traveling with the Device................................................................24
15. Service .............................................................................................25
16. Technical Support............................................................................25
17. Disposal ...........................................................................................25
18. Warranty..........................................................................................25
19. EMC Requirements..........................................................................26
Manufacturer:.........................................................................................29
U.S Agent: .............................................................................................30
1
1. Introduction
1.1 Intended use
The BEYOND ResPlus C-20A CPAP is designed for delivery of positive airway
pressure to provide non-invasive ventilation for adult patients with respiratory
insufficiency or obstructive sleep apnea (OSA) in home or hospital environment.
Rx only: Federal law restricts this device to sale by or on the order of a licensed
healthcare practitioner.
Please consult with a licensed health care professional prior to using this device.
BEYOND Medical manufactures several accessories that are available to make your
OSA treatment with this device as convenient and comfortable as possible. To
ensure that you receive the safe and effective therapy, only use accessories
manufactured by BEYOND Medical with this device.
1.2 Warnings
These warnings are meant to caution the user or operator of this device that there is a
substantial risk of injury if these warnings are not followed.
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.
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 EN60601-1-2 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).
Use only BEYOND Medical circuit accessories.
Do not wear the mask for longer than a few minutes while the device is not in
operation.
Keep the device dry, ensure the tubing isn’t tangled.
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.
The C-20A CPAP, like all CPAP devices, has a potential to allow users to
rebreathe their own exhaled air. To reduce the chance of this possibility occurring,
please observe the following precautions:
- Only use BEYOND Medical circuit accessories.
- Do not wear the mask for longer than a few minutes while the device is not
in operation.
- Do not block or seal the vent holes in the exhalation port.
This device is not recommended to be used in combination with oxygen therapy.
Sources of medical oxygen must be located more than1 meter from this device to
avoid the risk of fire.
Do not operate this device in the presence of flammable anesthetic mixtures,
especially in combination with oxygen.
2
Do not operate this device in the presence of nitrous oxide and oxygen.
Keep away from toxic or hazardous steam.
Do not use this device if the room temperature is higher than 35℃(95°F). If the
ambient temperature of the room is higher than 35℃(95°F), the air flow from the
device may rise to exceed 40℃(105°F), which may cause damage to the user’s
airway.
Do not use this device in direct sunlight or near heating equipment. Doing so
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.
Contact your healthcare provider if symptoms of sleep apnea recur.
Regularly check the power cable and accessories for any damage or wear.
Disconnect the power supply before checking the device.
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 tubing to flow
into the user’s nose, creating the risk of possible suffocation.
Stop using this device if the humidifier is damaged.
Do not touch the heater plate after turning the device off. Let the heater plate
cool off before touching. The plate will remain hot for several minutes after the
power supply has been disconnected.
Do not add water hotter than 35℃(95°F).
Do not splash any water into the device when refilling the water tank.
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.
Appliance coupler is used as isolation means for the device, please do not
position the device so that it is difficult to operate the coupler.
Do not attempt to modify this device without written authorization from the
manufacture.
Do not place the device next to any curtains or similar obstruction. Curtains can
block the airflow to the device, which may cause this device to overheat.
Do not block the air Intake Port. Doing so will interfere with the therapy.
The proper placement and positioning of the mask on the face is critical to the
consistent operation of this device.
The local distributor of this device is available to provide technical support.
Do not perform any maintenance on the device while user is receiving the
treatment.
All materials that come in contact with the human body have been tested for
biocompatibility and meet the requirements of biological compatibility
Approved adapters are specified as part of the device.
1.3 Cautions
The following precautionary statements indicate conditions or actions that might
damage the device or injure the user. Please read this section carefully.
Do not begin wearing the mask until the device has started to run normally.
Do not operate the device if the ambient temperature is outside of the operating
temperature range (listed under Section 13). If the device has been exposed to
temperatures that are above the operating temperature range, return the device to
room temperature before use.
3
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.
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.
Take all possible preventive measures to avoid water damage to the device.
Only use distilled 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.
1.4 Contraindications
If the user has severe respiratory failure without spontaneous breathing, do not use
the device. If any of the following conditions apply, consult the healthcare provider
before using the device.
Absolute contraindications:
Pneumothorax or 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 that makes using the mask during therapy impossible; or 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 the 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 symptoms of discomfort, please contact your healthcare provider
immediately.
4
2. Model
Model
Type
Main components
Working
Mode
MaxPressure
（cmH2O）
C-20A
Auto
CPAP
Host Humidifier H10
SpO2 Kit S10(optional)
CPAP
APAP
20
3. Package Contents
Item
Articles
Quantity
Remark
1
Host
1
Standard
2
Humidifier
1
Standard
3
Tubing
1
Standard
4
Mask
1
Standard
5
Adapter
1
Standard
6
User Manual
1
Standard
7
Air Filter
2
Standard
8
SpO2 Kit
1
Optional
9
Carrying Case
1
Standard
10
TF Card
1
Standard
4. Device Components
Fig. 4.1
Fig. 4.2
5
1
Dial
Can be rotated in either direction or pressed to select.
2
Mute
Pressing this button turns off the voice alarm
3
On/Off Button
Pressing this button switches the device On or Off.
4
Air Outlet
This is the connection point for the tubing
5
Humidifier
Separation Button
Pressing this button separates the humidifier from the
host unit.
6
Air Inlet
The air filter is placed in this air exchange port.
7
SpO2 Port
This is the connection point for the SpO2 Kit
8
Data Port
This is the port for connecting to an external data
device.
9
TF Card port
This is the port where a TF card is inserted.
10
Power Port
This is where the cord from the adapter is Connected.
Do not remove the Dial cap. The metal rod connected to the Dial may come in
contact with the external current, creating the risk of an electric shock. If the Dial
cap falls off, contact the local distributor to purchase a replacement.
In case of the failure of any of the buttons, contact the local distributor.
5. Device Symbols
These symbols are provided in the labeling papers to give users safety instructions,
please read through their definitions carefully before using.
Symbol
Definition
Warnings or Caution
Type BF applied part
Serial number of the product
Date of manufacture
Follow instructions for use
The authorized EU-representative
Manufacturer’s Information
CE Mark
IP22
Degree of Protection Against Ingress of Water and
Particulates
Conforms to the Waste Electrical and Electronic
Equipment /the Restriction of the Use of Certain
Hazardous Substances in Electrical and Electronic
Equipment
6
Heat Warning
Rx Only
Caution: Federal law restricts this device to sale by or on
the order of a licensed healthcare practitioner.
6. Device Operation
6.1 First Use
6.1.1 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 2 inches between the device and the wall to ensure that the
air inlet is not obstructed.
When using the device, ensure that the surrounding air flows freely. Keep the
device away from any heating and cooling devices (air conditioning vents,
radiators, etc )
6.1.2 Place the air filter in the slot at the Air Inlet port.
6.1.3 Connect one end of the tubing into the Air Outlet.
6.1.4 Connect the mask into the other end of the tubing.
6.1.5 Connect the power adapter into the Power Port on the rear of the device.
6.1.6 Connect the device to mains power supply. The device will display the Standby
Interface
6.1.7 Connect the power supply. Press the On/Off Button to start the device.
The Connections should appear as shown in Fig 6.1 below:
Fig.6.1
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.
Do not place the device in or on a container where water may gather.
Be sure to take preventive measures in order to avoid water damage to the device.
When water is in the humidifier, do not move the device, so as to avoid water
entering into the device.
6.2 Daily Use
6.2.1 Assembling the Device
7
Connect the power supply and the tubing as listed for the first use (see above).
Connect the mask and the headgear according to the Mask User Manual
(provided separately).
6.2.2 Adjust the Tubing
Adjust the tubing to make sure the tubing can move freely when the user is in a
deep sleep. Adjust the mask and the headgear to make the user feel as
comfortable as possible and prevent air from blowing into the user’s eyes.
6.2.3 Start the Device Running
Press the On/Off Button. The device will begin to run and therapy data (such as,
air pressure and temperature) will be shown on the display screen.
6.2.4 Humidifier Heating
If using the humidifier, it is recommended that the unit be used with the tubing
which provided by BEYOND Medical to prevent leakage. If the humidifier is
attached to the device but the user does not want to use the humidifier, turn the
humidifier off.
6.2.5 Ramp Function
When using the Ramp Function, the device will begin at a low initial pressure
and increase to the desired pressure setting in a steady rise over the time period
selected by the user. After this function is selected, press the On/Off Button
once, the device will start to run in accordance with the Ramp Function’s
settings. If the On/Off Button is pressed a second time, the device will cancel
the Ramp Function and run at the selected pressure.
6.2.6 Turn Off the Device
When the mask is taken off, the device will stop running. The user then needs to
turn off the device by unplugging the power supply.
7. Humidifier
In drier regions, prolonged use of the device may dry out the user’s nasal
passages, causing discomfort. This device is equipped with a humidifier to
address this issue. When water is added to the humidifier and it is turned on,
moisture will be added to the inhaled air to moisten the user’s nasal passages.
7.1 Humidifier Composition
Fig.7.1
1
Air Outlet
8
2
Humidifier Cap Key
3
Water Checking Window
4
Air Inlet
5
Humidifier Connector
6
Humidifier Separation Key
7.2 Humidifier Connection & Separation with the Host
Unit
7.2.1 Connect with the host unit
Fig.7.2.1a Before the connection Fig.7.2.1b After the connection
Push the host unit and humidifier together to connect them to each other. A “click”
sound will be heard when they are properly connected.
Push the humidifier to connect with the host completely.
7.2.2 Separate from the host unit
Fig.7.2.2
Press the Humidifier Separation Button while simultaneously pulling the humidifier
apart from the host unit.
7.2.3 Adding water into the water tank
(1) Take out the water tank: move the humidifier cover by sliding the Humidifier Cap
Key to the right side as shown in Fig.7.2.3a below. Then, open the humidifier cover to
take out the water tank by grasping the tank with thumb and index finger as pictured in
Fig.7.2.3b.
9
Fig.7.2.3a Fig.7.2.3b
(2) Add water through the Air Inlet port on top of the water tank. Make sure the water
level does not exceed the Max line.
Fig.7.2.3c
In winter months, be sure to add warm water, but no hotter than 35℃(95°F).
Do not fill the water tank above the Max line.
Turn off the humidifier when the water tank is empty. Turn the device off before
refilling water. Do not add water when the humidifier is in operation. Only add water
when the humidifier has cooled down.
Do not let any water enter the host unit.
8. Using the SpO2 Kit
The SpO2 Kit consists with a SpO2 Probe, Adapter, and Connector. The SpO2 Kit is
intended to be used for continuous, non-invasive functional arterial oxygen saturation
(SpO2) and pulse rate monitoring for adults weighing more than 40 kg (90 pounds).
The SpO2 Kit is immediately ready to use when it is connected to the main device via
the Communications Port. Attach the Oxygen Probe sensor to the user's index finger
(although other fingers can also be used).
The sampling frequency of the SpO2 signal is 50Hz, and the update frequency of the
device is 1Hz. The value of SpO2 is calculated by the average of the previous eight
pulse waveforms.
If the SpO2 Kit does not connect or is not performing correctly, the value of SpO2 will
not be displayed on the Main Interface.
10
9. Parameter settings
9.1 Main Interface Screens
Connect the device properly to mains power supply with power cord and power
adapter. The screen displays the Main Interface screen will appear as shown in Fig.
9.1 below.
Fig.9.1: C-20A Main Interface
Users can set the desired humidifier levels and the Ramp time on the Main
Interface; the selectable values ranges are preset on the parameter interface.
When the humidifier is not connected to the device, the Humidifier setting icon in
the main Interface is grayed and cannot be accessed.
SpO2 and Pulse Rate are only displayed when the SpO2 Kit (optional parts) is
correctly attached.
Icon
Meaning
1
The TF card is inserted.
2
The device is working.
3
The Ramp function has been set.
4
The humidifier level has been set.
5
Indicates that the parameters setting interface is locked.
When the device is connected to the power, its locked by
default; Unlock the parameter interface by pressing the Dial
button and holding for 5 seconds while the cursor is located
on “Parameter” option. After unlocking successfully, the
icon will change to .
11
9.2 PFCurve interface
Under main interface, rotate the “Dial”button to move the cursor onto the “PFCurve”
indicator and press “Dial” button; the PFCurve Interface screen will appear on the
display screen, as shown in Fig. 9.2 below.
Fig.9.2: C-20A PFCurve Interface Screen
9.3 Parameter Setting Interface
Under the main interface, rotate the "Dial" button to move the cursor onto the
“Parameters” icon, and then press the " Dial " button for 5 seconds to unlock. This will
bring you to Parameter Setting Interface screen, as shown in Fig.9-3a below. Next,
press the " Dial " button again and the selected font will turn yellow, indicating that
the device’s parameters can now be set, as shown in Fig. 9-3a through Fig. 9.3.c
below.
Fig.9.3a : C-20A Parameter Setting Interface Screen 1
12
Fig.9.3.b : Selected Status Screen
Fig.9.3c : C-20A Parameter Setting Interface Screen 2
Parameter
Range
Description
Auto ON
ON/OFF
When the Auto ON is set to “ON”, the user can wear
the mask and take 3 breaths in device’s Standby State.
The device will then automatically enter into the
Working State.
Auto OFF
ON/OFF
When the Auto OFF is set to “OFF, the user needs to
remove the mask while the device is in the Working
State. Within 15 seconds the device will automatically
enter into the Standby State. When this 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.
* Mode
APAP/C
PAP
The APAP mode allows pressure to be automatically
adjusted for improved user comfort based on continual
monitoring of apnea and snoring events. The CPAP
mode provides a constant level of pressure throughout
the breathing cycle.
13
*Press
4-20
cmH2O
This setting sets the output pressure for the device. It
can be set in increments of ±0.5 cmH2O.
*StartPress
4.0-20.0
cmH2O
CPAP Mode: The initial air pressure for the Ramp
Function is equal to or less than the standard air
pressure selected by the user.
APAP Mode :
1. When the initial air pressure is equal to or
less than the minimum pressure, it is used as
the starting pressure to begin the Ramp
Function.
2. When the initial pressure is greater than the
minimum pressure, it is used as the output
pressure after power is turned ON.
This parameter can be set in increments of ±0.5
cmH2O.
*MinPress
4.0-20.0
cmH2O
The minimum output pressure parameter can be
auto-adjusted at increments of ±0.5 cmH2O.
*MaxPress
4.0-20.0
cmH2O
The maximum output pressure parameter can be
auto-adjusted at increments of ±0.5 cmH2O.
*Belex
0-3 level
Setting the Belex function while the device is in CPAP
Mode will enable the device to detect the respiratory
rhythm of the user. This function will lower the
pressure in the mask during exhalations to make the
user feel more comfortable.
Ramp
0-60 min
This parameter sets the time it takes for the air pressure
to ramp up to the final pressure selected by the user
(MaxPress)
Humidifier
0 (OFF)
to 5
(Maximu
m)
This parameter sets the output air humidity level for
the device. The higher the value, the higher the
humidity.
"0" indicates that the humidifier is off.
The default value before dispatched from the
manufacturer is “0”.
Tips
"*" indicates that this parameter can only be adjusted while the
parameter interface is unlocked. To unlock the parameter interface,
position the cursor over the “Parameter” icon and then press and
hold the Dial Button for 5 seconds to unlock.
9.4 System Setting Interface
Rotate the "Dial" button so that the cursor on the Main Interface screen is pointing at
“System”, then press the "Dial" button to enter into the System Setup Interface screen,
as shown in Fig.9.4a .
14
Fig.9.4a : System Setting Interface Screen 1
Fig.9.4b : System Setting Interface Screen 2
Fig.9.4c: System Setting Interface Screen
(with Reset Dialogue Box active)
15
9.5 Information Setting Interface
Fig.9.5a : C-20A Information Setting Interface 1
Parameter
Setup range
Description
Time
h-m-s
This parameter sets the device’s internal clock to
track the time. This time will then be used to record
the application information for users. This setting
needs to be checked frequently to ensure continued
accuracy.
Date
yyyy-mm-dd
This parameter sets the device’s internal calendar to
track the date. This date will then be used to record
the application information for users. This setting
needs to be checked frequently to ensure continued
accuracy.
BackLight
30-600 sec
This parameter sets the length of time that the LCD
display will be back lit. When the user sets a value,
the backlight will turn off after the set time elapses.
Brightness
1-5 level
This parameter has a five-level range. The higher
the level, the greater the screen brightness.
Language
Chinese-
English
Can be switched from English to Chinese. Chinese
language User Manuals can be requested from the
manufacturer.
PressUnit
cmH2O-hPa
Displayed values can be switched between
“cmH2O” and “hPa”, as desired by the user.
Reset
------
System Restore will return all system parameters
back to the factory default values.
HighLeaka
ge
OFF/ON
This parameter sets the high leakage prompt
function for the device.
16
Fig.9.5b : C-20A Information Setting Interface 2
Parameter
Setup range
Description
UseCycle
1/7/30/90/180/36
5
The time period over which the following
information items are calculated. Unit is
"day".
UseTime
------
The length of time that the device has been
connected to the power supply. Unit is
“hour”.
AvgPress
------
The average output pressure value of the
device in the running state within the life
cycle. Unit is “cmH2O”.
TiPressure
------
The 95% output pressure value of the device
in the running state within the life cycle,
measured by usage time. Unit is “cmH2O”
AvgLeakage
------
The average leakage value of the device in
the running state within the lifecycle. Unit is
“L/min”.
RunHrs
------
The duration of running time after the device
is shipped from factory. This value cannot be
cleared.
AHI
------
Apnea-hypopnea index of the device in the
using cycle. Calculation method as
Apnea-hypopnea frequency per hour
UseDays
------
The device is connected to the power supply
and continuously running for 4 hours or more
it is counted as 1 day.
9.6 Epworth Interface
17
Fig.9.6a : Epworth Interface Screen 1
Fig.9.6b : Epworth Interface Screen 2
Fig.9.6c :Epworth Interface Screen 3
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