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Nuance gel pillows mask
Instructions for Use - English
Intended Use
This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients.
The mask is for single patient use in the home or multi-patient use in the hospital/institutional
environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy
has been prescribed.
Note
:
•
An exhalation port is built into this mask so a separate exhalation port is not required.
•
This mask is not made with natural rubber latex or DEHP.
Caution
: U.S. Federal law restricts this device to sale by or on the order of a physician.
Symbols
Warning or Caution
Note
Tip
Consult Instructions for
Use
Not Made with Natural
Rubber Latex
X2
System One Resistance
Control
Warnings
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This mask is not suitable for providing life support ventilation.
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Hand wash prior to use. Inspect the mask for damage or wear (cracking, crazing, tears, damage resulting in gel
exposure, etc). Discard and replace any components as necessary.
•
Some users may experience skin redness, irritation, or discomfort. If this happens, discontinue use and contact
your healthcare professional.
•
Consult a physician or dentist if you encounter tooth, gum, or jaw soreness. Use of a mask may aggravate an
existing dental condition.
•
Consult a physician if you experience the following symptoms while using the mask or after removing it: Drying
of the eyes, eye pain, eye infections, or blurred vision. Consult an ophthalmologist if symptoms persist.
•
The mask material should be away from your eyes.
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Do not overtighten the straps. Watch for signs of overtightening, such as excessive redness, sores, or bulging skin
around the edges of the mask. Loosen the straps to alleviate symptoms.
•
This mask is designed for use with CPAP or bi-level systems recommended by your health care professional
or respiratory therapist. Do not wear this mask unless the CPAP or bi-level system is turned on and operating
properly.
Do not block or try to seal the exhalation port. Explanation of the Warning
: CPAP systems are
intended to be used with special masks with connectors which have vent holes to allow continuous flow of
air out of the mask. When the CPAP machine is turned on and functioning properly, new air from the CPAP
machine flushes the exhaled air out through the attached mask exhalation port. However, when the CPAP
machine is not operating, enough fresh air will not be provided through the mask, and exhaled air may be
rebreathed. Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to
suffocation. This warning applies to most models of CPAP systems.
•
If oxygen is used with the device, the oxygen flow must be turned off when the device is not operating.
Explanation of the Warning
: When the device is not in operation, and the oxygen flow is left on, oxygen
delivered into the ventilator tubing may accumulate within the device enclosure. Oxygen accumulated in the
device enclosure will create a risk of fire.
•
Do not block or seal off the exhalation ports.
