1. Introduction
1 Intended use
The ResFree Positive Airway Pressure Devices are intended to provide non-invasive ventilation
for adult patients with obstructive sleep apnea (OSA). The device is intended for use in the
hospital or home.
Through non-invasive ventilation, such as wearing masks, the device provides a single 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.
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 original 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 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 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.
1.2 Warnings
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