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608138r3.pdf, Ultra mirage, Intended use – ResMed Non-Vented Full Face Mask Ultra Mirage User Manual

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Eng

lish

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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 (>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.

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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.

If oxygen is used with the ventilator, the oxygen flow must be turned off
when the ventilator is not operating.
Explanation: When the ventilator is not in operation, and the oxygen flow
is left on, oxygen delivered into the ventilator tubing may accumulate within

608138r3.book Page 1 Tuesday, April 10, 2007 2:41 PM