Instructions for Use - English
Pico Traditional Nasal Mask
Intended Use
This 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 (> 66 lbs/30 kg)
for whom CPAP or bi-level therapy has been prescribed.
Notes:
• Exhalation is built into this mask. A separate exhalation device 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.
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.
• 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 problems.
• 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.
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