User Manual

1
The mask is a noninvasive accessory used for channeling airflow (With or
without supplemental oxygen) to a patient from a positive airway.
y Pressure (PAP) device such as a continuous positive airway pressure
(CPAP) or bi-level system.
y The mask is to be used by patients (weighing>30kg), intended for single-
patient reuse in the home environment.
y The mask is intended for single-patient use in the hospital or institutional
environment.
If the user has the following diseases, the product may not be suitable for use.
Special attention should also be given when it must be used. In either case, it
is up to the doctor to decide whether or not to use the mask. These diseases
include:
y Recent eye surgery or dry eyes
y Glaucoma
y Hiatal hernia
y Impaired cardiac sphincter function, excessive reflux, impaired cough reflex
y Vomiting
y Bullous Lung Disease
y Pathologically Low Blood Pressure
y Bypassed Upper Airway
y Pneumothorax
y Diagnosed with acute sinusitis or otitis media
y At risk for aspiration of gastric contents
y Allergy or hypersensitivity to the mask materials, or on patients unable to
remove the mask
CAUTION:
In the US, Federal law restricts the sale of this device to sale by or on the
order of a physician.
WARNINGS
y Please read the entire guide before use.
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