Intended Use - ResMed Pixi User Manual

Pixi
™
pediatric mask
Thank you for choosing the Pixi Pediatric mask. Please read the entire manual before use.

Intended use

The Pixi Pediatric mask channels airflow noninvasively to a patient from a continuous
positive airway pressure (CPAP) or bilevel device ('device').
The Pixi Pediatric mask is:
• to be used by children aged between 2 and 7 for whom continuous positive airway
pressure (CPAP) or bilevel therapy has been prescribed
• intended for single-patient re-use in the home and single patient re-use in the hospital/
institutional environment.
WARNING
•
This mask is designed to provide a stable effective air seal with minimum
headgear tension. High headgear tension may lead to facial deformities with
long-term use. Regular clinician review of growth patterns and the use of
different styles of mask is recommended.
• The mask must be used under qualified supervision for patients who are unable
to remove the mask by themselves.
• The mask may not be suitable for those predisposed to aspiration.
• If the mask is prescribed for children with serious congenital conditions
or cognitive impairments, then using a device with appropriate alarms is
recommended. The correct operation of the complete patient circuit, including
alarms must be tested before commencing therapy.
• 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.
• The vent holes must be kept clear and must not sit against the nose.
• 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 vent holes 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 vent holes. However,
when the device is not operating, insufficient fresh air will be provided through
the mask, and the exhaled air may be rebreathed. Rebreathing of exhaled air for
longer than several minutes can, in some circumstances, lead to suffocation. This
applies to most models of CPAP or bilevel devices.
• This mask should only be used with CPAP or bilevel devices recommended by a
physician or respiratory therapist.
• Using a mask may cause tooth, gum or jaw soreness or aggravate an existing
dental condition. If symptoms occur, consult your physician or dentist.
• Remove and dispose of all packaging before using the mask.
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