Intended Use; Warnings And Cautions - ResMed Ultra Mirage Manual De Instrucciones

Ultra Mirage
NON-VENTED FULL FACE MASK
The Ultra Mirage NV (non-vented) Full Face Mask is a non-invasive device used
for channelling air flow with or without supplemental oxygen.

Intended Use

The Ultra Mirage NV Full Face Mask is intended to be used with active-exhaust-
valve ventilator systems, to provide ventilatory assistance to patients with
respiratory insufficiency and respiratory failure.
The Ultra Mirage NV Full Face Mask is to be used on adult patients
(>66 lb/30 kg), requiring non-life-support ventilatory assistance.
The Ultra Mirage NV Full Face Mask is intended for single-patient re-use in the
home or multipatient re-use in the hospital/institutional environment.
CAUTION
In the USA, federal law restricts this device to sale by, or on the order of, a
physician.

WARNINGS AND CAUTIONS

.
The Ultra Mirage NV Full Face Mask, must not be used without qualified
•
supervision for patients who are unable to remove the mask by themselves.
This mask is not for use on patients with impaired laryngeal reflexes or other
•
conditions predisposing to aspiration in the event of regurgitation or
vomiting.
The mask should not be worn unless the ventilator system is turned on and
•
operating properly.
At a fixed rate of supplemental oxygen flow (if used), the inhaled oxygen
•
concentration will vary depending on the pressure settings, patient
breathing pattern, mask size selection and the mask leak.
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