GENERAL WARNINGS
• This mask is to be used with patients requiring non-life support
ventilatory assistance.
• This mask must be used with an external exhalation device. This
mask must be fitted, and therapy maintained by trained medical
staff. Failure to monitor the patient may result in loss of therapy,
serious injury or death.
• This mask must be used under qualified supervision for users
who are unable to remove the mask by themselves or are at risk
of not responding to an issue. This mask is not suitable for
individuals predisposed to aspiration. Failure to use under
supervision in these circumstances may result in serious injury or
death.
• This mask does not contain an exhaust feature or anti-asphyxia
valve (AAV). This mask must be used with a non-invasive
ventilation (NIV) circuit with an exhaust system or a Positive
Pressure Ventilator with an exhalation valve. When the ventilator
is functioning properly, the exhalation valve allows exhaled air to
escape to ambient. When the ventilator is not operating, exhaled
air may be re-breathed. Re-breathing exhaled air can in some
circumstances, lead to suffocation and/or injury.
• The mask should not be used unless the ventilator device is
turned on.
• Avoid connecting flexible PVC products (eg., PVC tubing) directly
to any part of the mask. Flexible PVC contains elements that can
be detrimental to the materials of the mask, and may cause the
components to crack or break.
• Follow all precautions when using supplemental oxygen.
• Oxygen flow must be turned off when the ventilator device is not
operating (if used), so that unused oxygen does not accumulate
within the device enclosure and create a risk of fire.
• Oxygen supports combustion. Oxygen must not be used while
smoking or in the presence of an open flame. Only use oxygen in
well ventilated rooms.
• At a fixed rate of supplemental oxygen flow, the inhaled oxygen
concentration varies, depending on the pressure settings, patient
breathing pattern, mask, point of application and leak rate.
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