Intended Use - PHILIPS Respironics ComfortGel Full Instructions For Use Manual

Intended Use

The ComfortGel Full Face 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 and multi-patient use in the hospital/institutional
environment. The mask is to be used on patients (>66lbs/30kg) who are
appropriate candidates for noninvasive ventilation.
Important Note: An exhalation port is built into the ComfortGel Full Face
Mask so a separate exhalation port is not required.
Caution
U.S. Federal law restricts this device to sale by or on the order of a physician.
INSTRUCTIONS FOR USE
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