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Ocular implants (e.g., glaucoma implants, retinal implants) Metallic cranial plates, screws, burr hole covers, and bone substitute devices Intracranial aneurysm intravascular flow disruption devices Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) shunt) Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)
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Implantable cardioverter defibrillators (ICD) This represents a new and industry-leading practice.Ĭontraindication: Use of the mask is contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks, that have implanted devices that may be affected by magnets, including but not limited to: All users should read and follow Philips Respironics’ voluntarily updated warning and added contraindication described below. This is a voluntary notification to users of specific CPAP or Bi-Level PAP therapy masks containing such magnetic clips to inform them of the updated instructions and labeling. The magnetic headgear clips are used to attach the headgear straps to the masks, which is a method that is commonly used in the sleep therapy devices industry. See More users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body. Royal Philips’ (NYSE: PHG AEX: PHIA) subsidiary Philips Respironics is alerting.
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These masks may continue to be used 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.
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