General Warnings - ResMed AirFit F20 User Manual

QuietAir
The QuietAir elbow is intended for single-patient reuse in both home and
hospital/institutional environments.
WARNING
Magnets are used in the lower headgear straps and the frame of the
F20. Ensure the headgear and frame is kept at least 2" (50 mm) away
from any active medical implant (eg, pacemaker or defibrillator) to
avoid possible effects from localised magnetic fields. The magnetic
field strength is less than 400 mT.
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.
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