Intended Use

English

Hospital Mask

NON-VENTED FULL FACE MASK

The ResMed Hospital NV (non-vented) Full Face Mask is a disposable non-invasive device used for channelling air flow with or without supplemental oxygen.

The ResMed Hospital 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.

•to be used on adult patients (>30 kg), requiring non-life-support ventilatory assistance.

•for single-patient use, for a maximum of seven days, in the hospital or clinical environment.

. WARNINGS and CAUTIONS

• This 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 the ventilator enclosure. Oxygen accumulated in the ventilator enclosure will create a risk of fire. This warning applies to most types of ventilators.

• Please refrain from smoking while oxygen is in use.

• Leak or variation in the leak may cause mistriggering of the ventilator.

• In determining ventilator settings, and in particular the tidal volume for volume- cycled ventilators, make appropriate allowance for mask dead space and leak.

• As with all mask ventilation systems, significant leak may occur between the mask and the patient's face. The leak may vary depending on such factors as the patient ventilation, potentially producing profound hypoventilation or hyperventilation. The magnitude of this effect depends on the ventilator's ability to compensate.