Updated Information on Masks with Magnets for Mask Users

Updated 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 (i.e., pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps)
• Metallic implants/objects containing ferromagnetic material (i.e., 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)

Updated Warning

Keep the mask magnets at a safe distance of at least 6 inches (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 400mT. 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, e.g., 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.

Note, not all models or variants of medical devices listed in the contraindications are affected by external magnetic fields. If you are not sure whether an implant or medical device falls under the contraindications, or you require additional information on the potential adverse effects of magnetic fields for your particular implant or medical device, please contact your physician/doctor.

Does this apply to me?

• If you do not use a mask with magnets, the updated contraindications and warnings do not apply to you.
• The updated contraindications for ResMed masks with magnets only apply if you, or anyone in close physical contact with you while using the mask (e.g., bed partner), has a certain implant or medical device that is identified above.
• If you use a ResMed mask with magnets, you should also be aware of the updated warning noted above.

Which ResMed masks contain magnets?

• AirTouch F20
• AirTouch N20
• AirFit F30i
• AirFit N20
• AirFit F20
• AirFit F30

Are ResMed masks with magnets safe to use as directed?

ResMed's masks with magnets are safe when used in accordance with the updated instructions for use, including the contraindications and warnings.

What is the benefit of using a mask with magnets?

Magnets are used in some ResMed masks to provide a simple and easy way for the user to attach and detach the headgear to the mask frame. This can be notably beneficial to users with disabilities, including those facing dexterity or vision impairment.

What does ferromagnetic mean?

Ferromagnetic refers to a material property that is influenced by magnetic fields (e.g., attracts/repels under magnetic fields). Materials that are ferromagnetic are generally made of iron, cobalt, nickel, or some alloys made of these elements.

Not all medical implants listed in the contraindications are made from ferromagnetic materials. If you are not sure whether an implant or medical device falls under the contraindications, or you require additional information on the potential adverse effects of magnetic fields for your particular implant or medical device, please contact your physician/doctor.

What should I do if my bed partner or I have an implant or medical device that falls under the contraindications?

Replace your mask containing magnets with an alternative mask without magnets in a timely manner. Contact your mask provider for alternative mask options.

If you are not sure whether an implant or medical device falls under the contraindications, or you require additional information on the potential adverse effects of magnetic fields for your particular implant or medical device, please contact your mask provider or physician/doctor.

What masks can I use if I am contraindicated?

Contact your mask provider for alternative non-magnet mask options.