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Instructions for use - English
Intended Use
The Wisp Nasal 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.
The Wisp Youth Nasal 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 7 years or older (>40 lbs/18
kg) for whom CPAP or bi-level therapy has been prescribed.
Notes:
• Exhalation is built into this mask so a separate exhalation device is not required.
• This mask is not made with natural rubber latex or DEHP.
Symbols
Warning or Caution
Not Made with Natural Rubber
Latex
Warnings
• This mask is not suitable for providing life support ventilation.
• Hand wash prior to use. Inspect the mask for damage or wear (cracking, crazing, tears, 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.
• Do not block or seal off the exhalation ports.
• Do not overtighten the headgear straps. Watch for signs of overtightening, such as excessive
redness, sores, or bulging skin around the edges of the mask. Loosen the headgear 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. 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.
• At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary,
depending on the pressure settings, patient breathing pattern, mask selection, and the leak rate.
This warning applies to most types of CPAP and bi-level machines.
• At low CPAP or EPAP pressures the flow through the exhalation port may be inadequate to clear
all exhaled gas from the tubing. Some rebreathing may occur.
• Attaching an exhalation device requires therapy pressure level adjustment to compensate for
increased leak.
Note
X1
System One Resistance
Control
1
Tip
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