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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.
