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Contraindications
Masks with magnetic components are contraindicated for use by patients
where they, or anyone in close physical contact while using the mask,
have the following:
• Active medical implants that interact with magnets (ie, pacemakers,
implantable cardioverter defibrillators (ICD), neurostimulators,
cerebrospinal fluid (CSF) shunts, insulin/infusion pumps)
• Metallic implants/objects containing ferromagnetic material (ie,
aneurysm clips/flow disruption devices, embolic coils, stents, valves,
electrodes, implants to restore hearing or balance with implanted
magnets, ocular implants, metallic splinters in the eye).
WARNING
Keep the mask magnets at a safe distance of at least 6" (150 mm)
away from implants or medical devices that may be adversely
affected by magnetic interference. This warning applies to you or
anyone in close physical contact with your mask. The magnets are in
the frame and lower headgear clips, with a magnetic field strength of
up to 400 mT. When worn, they connect to secure the mask but may
inadvertently detach while asleep.
Implants/medical devices, including those listed within
contraindications, may be adversely affected if they change function
under external magnetic fields or contain ferromagnetic materials
that attract/repel to magnetic fields (some metallic implants, eg,
contact lenses with metal, dental implants, metallic cranial plates,
screws, burr hole covers, and bone substitute devices). Consult your
physician and manufacturer of your implant/other medical device for
information on the potential adverse effects of magnetic fields.
WARNING
• The mask contains safety features, the exhaust vent holes and
anti-asphyxia valve, to enable normal breathing and exhaust
exhaled breath. Occlusion of the exhaust vent holes or anti-
asphyxia valve needs to be prevented to avoid having an adverse
effect on the safety and quality of the therapy. Regularly inspect
the vent holes and anti-asphyxia valve to ensure they are kept
clean, clear of blockages and are not damaged.
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