1
DreamWear
Full Face Mask
Instructions for use -
e
1 Safety Information
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 therapy
or bi-level therapy has been prescribed.
Caution:
U.S. Federal law restricts this device to sale by or on the
order of a physician.
Note:
This mask is not made with natural rubber latex or DEHP.
Contraindications
This mask is not for use on patients with the following conditions:
recent eye surgery or dry eyes, hiatal hernia, excessive reflux, impaired
cough reflex, and impaired cardiac sphincter function. This mask is
not for use on patients who are dependent on mechanical ventilation
for their life support. This mask is not for use on patients who are
taking a prescription drug that induces vomiting, or on patients who
are uncooperative, unresponsive or unable to remove the mask by
themselves.
Warnings
•
Use of this mask while the system is not on and operating may
cause rebreathing of exhaled air. Rebreathing of exhaled air for
longer than several minutes can in some circumstances lead to
suffocation.
