Disclaimer

This information pertains to a limited number of CPAP therapy users (and their bed partners) who have active medical implants such as a pacemaker, defibrillator, magnetic cerebrospinal fluid (CSF) shunt valve, or cochlear implants. Masks with magnets are contraindicated (not appropriate) for patients with the following pre-existing conditions listed below. Stop the use of the mask that contains magnets and switch to a non-magnetic mask (when available) if the wearer or someone near them when using a recalled mask has any of the implanted metallic medical devices or metallic objects in the body listed that may be affected by the magnets in the masks. The list of devices includes (but is not limited to):

• Pacemakers
• Implantable cardioverter defibrillators
• Metallic stents (such as aneurysm, coronary, tracheobronchial, and biliary)
• Neurostimulators (such as hypoglossal nerve stimulators)
• Magnetic metallic implants, electrodes, and valves placed in upper limbs, torso, neck, or head
• Cerebral spinal fluid shunts (such as ventriculoperitoneal shunt)
• Aneurysm clips
• Embolic coils
• Intracranial aneurysm intravascular flow disruption devices
• Metallic cranial plates, screws, burr hole covers, and bone substitute devices
• Ocular implants (such as glaucoma implants and retinal implants; intraocular lenses placed during cataract surgery are not impacted)
• Certain contact lenses with metal
• Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
• Magnetic denture attachments
• Implantable ports and pumps (such as insulin pumps)
• Metallic gastrointestinal clips
• Certain metallic joint replacements
• Devices labeled as Magnetic Resonance (MR) Unsafe
• Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field
• Metallic splinters in the eye
• Metallic shrapnel in the body

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.

Patients should consult a physician immediately to determine if another mask can be used for their therapy. Switch to a non-magnetic mask if available, for continued therapy. Dispose of the mask that has magnets after an alternative is obtained. Continue using masks according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.