ResMed 608140/20611 manual Intended Use

English

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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