Intended Use - Respironics FITLIFE Instructions D'utilisation

Intended Use

The FITLIFE total face mask is intended to provide an interface for application of CPAP or bi-level therapy to
patients. The mask is intended for single patient reuse in the home and multi-patient, multi-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.
Important
The FITLIFE mask is shipped with a built-in exhalation/air entrainment valve elbow attached. A separate
exhalation device is not needed with this elbow.
This mask is latex free and DEHP [Di(2-ethylhexyl)phthalate] free.
Caution or Warning
Warnings
The FITLIFE 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 the fresh air inlet on the entrainment valve. Ensure
of the mask. When the CPAP machine is turned on and functioning properly, new air from the CPAP
machine is not operating, enough fresh air will not be provided through the mask, and exhaled air may be
rebreathed.
A minimum pressure of 3 cm H
from the tubing. Some rebreathing may occur.
The air entrainment valve in this mask interface will disable your therapy device's auto-on feature
not operating.
is left on, oxygen delivered into the ventilator tubing may accumulate within the device enclosure. Oxygen
Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open
on the pressure settings, patient breathing pattern, nasal interface selection, and the leak rate.
System pressure and oxygen therapy may be different for a full or total face mask than for a nasal or
nasal/oral interface. When changing mask types, determine the appropriate pressure level and oxygen
therapy. When using the clear elbow with built-in exhalation and air entrainment valve, continuous
intentional leak exists at the exhalation ports, you must ensure that the pressure and oxygen therapy are
maintained against this higher leak level.
Depending on the exhalation valve used, you may need to adjust the pressure level to compensate for the
additional leak of the exhalation device.
The patient's physician should be contacted if the patient experiences the following symptoms while
using the mask or after removing it: Unusual chest discomfort, shortness of breath, stomach distension,
belching, or severe headache; drying of the eyes, eye pain, or eye infections; blurred vision. (Consult an
ophthalmologist if symptoms persist.)
delivered.
Some users may experience skin redness. If this happens, contact your health care professional.
This mask is not recommended if the patient is taking a prescription drug that may cause vomiting.
Consult instructions for use
O (hPa) must be maintained when using this mask.
2
CPAP systems are intended to
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