Contraindications
Use of masks with magnetic components is contraindicated in
patients with the following pre-existing conditions:
a metallic hemostatic clip implanted in your head to repair
an aneurysm
metallic splinters in one or both eyes following a
penetrating eye injury.
GENERAL WARNINGS
The mask must be used under qualified supervision for
users who are unable to remove the mask by
themselves. The mask may not be suitable for those
predisposed to aspiration.
The mask must be fitted with the supplied elbow
(containing the valve and vent assembly) to ensure
safe and functional usage unless otherwise specified.
Do not use the mask if the valve or vent assembly is
damaged or missing.
The elbow, valve and vent assembly have specific
safety functions. The mask should not be worn if the
valve is damaged as it will not be able to perform its
safety function. The elbow should be replaced if the
valve is damaged, distorted or torn. The vent holes and
valve should be kept clear.
The mask should only be used with CPAP or bilevel
devices recommended by a physician or respiratory
therapist.
Avoid connecting flexible PVC products (eg, PVC
tubing) directly to any part of the mask. Flexible PVC
contains elements that can be damaging to the
materials of the mask, and may cause the components
to crack or break.
The mask should not be used unless the device is
turned on. Once the mask is fitted, ensure the device is
blowing air.
Explanation: CPAP and bilevel devices are intended to
be used with special masks (or connectors) which have
venting to allow continuous flow of air out of the mask.
When the device is turned on and functioning properly,
new air from the device flushes the exhaled air out
through the mask holes. When the device is turned off,
the mask valve opens to atmosphere allowing fresh air
to be breathed. However, a higher level of exhaled air
may be rebreathed when the device is off. This applies
to most full face masks for use with CPAP and bilevel
devices.
Follow all precautions when using supplemental
oxygen.
Oxygen flow must be turned off when the CPAP or
bilevel device is not operating, 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. This warning applies
to most types of CPAP or bilevel devices.
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