09-07-2022, 06:09 AM
Philips again!
https://www.philips.com/a-w/about/news/a...njury.html
And again alarm from Philips! Magnetic interference makes that a whole list of users should not use their masks with magnetic clips anymore...
WHAT ARE THEY UP TO????
Arie KLERK: Member of the Dutch Apnea Association staff ( https://apneuvereniging.nl) and proud to be the OSCAR Translations Team Coordinator.
***Please help us: We’re always looking for more translators and language editors***
Membership in the Advisory Members group does not imply medical expertise or qualification for advising Sleep Apnea patients, but just dedication to AB.
RE: Philips again!
My wife has a pacemaker. These devices, hers at least, is tested and manipulated by placing magnets over the device. This includes the frequency of her heartbeat. Obviously this can be bad.
Years ago I posted an article about a RT fitting one of the magnetic closure masks and the magnets came too close to the patients pacemaker and put them into tachycardia, his though was well we aren't going to use this mask for you.
I figured that this was not a risk I was willing to take thinking a cuddle or a hug might, just might cause such a problem.
What is PR doing? I think that inlight of their CPAP recall, which has significantly hurt them, that they did a risk evaluation across all their products, at least their CPAP related products, and are in the process of removing that threat. Note that the original warnings only warned of the CPAP patient having a pacemaker. This warning is about people around the Pacemaker patient wearing the magnet headgear.
They are protecting what is left of the company.
09-07-2022, 07:16 AM
(This post was last modified: 09-07-2022, 07:16 AM by StratCat48.)
RE: Philips again!
What is different about the Philips magnetic clips that may make them less safe than the magnetic clips on some Resmed masks? Airfit N20 for example?
RE: Philips again!
IMHO nothing.
It is possible they are stronger, but I have no knowledge of that. And sthength doesnt eliminate the issue, it only lessens it.
RE: Philips again!
(09-07-2022, 07:16 AM)StratCat48 Wrote: What is different about the Philips magnetic clips that may make them less safe than the magnetic clips on some Resmed masks? Airfit N20 for example?
I suppose one difference could be that Resmed actually performed the required biocompatibility evaluation. Or Resmed actually addressed the potential for a problem:
"ResMed’s magnetic clips are compliant with safety guidelines for magnetic field exposure levels for public use. For patients who have active medical implants, such as pacemakers or implantable defibrillators, it is recommended that the clips be kept at least 2 inches (50 mm) away from implants to avoid any potential interference. The magnetic clips are not suitable for use in cases where patients have a metallic hemostatic clip implanted in the head to repair an aneurysm, or a metallic splinter in one or both eyes."
RE: Philips again!
My wife has a spinal cord stimulator which can be turned off with a strong magnet. We both use the RM F-20 FFM with magnetic clips and she has not had an issue. We asked her Abbott rep about it and he told us the magnets aren't strong enough to affect the stimulator. But, to be on the safe side, don't put the clip on the stimulator site. He also told her she could try it herself to see what would happen. She did and it had no effect.
A lot of it depends on the certification of the device and where it is.
Homer
Advisory Members serve as an "Advisory Committee" to help shape Apnea Board's rules & policies.
Membership in the Advisory Members group does not imply medical expertise or qualification for advising Sleep Apnea patients concerning their treatment.
RE: Philips again!
(09-07-2022, 07:43 AM)Gideon Wrote: IMHO nothing.
It is possible they are stronger, but I have no knowledge of that.
This article cites the same 400mT that ResMed states. So no difference.
https://www.globenewswire.com/news-relea...of-se.html
(09-07-2022, 12:30 PM)TimaaaaaaaahRocks Wrote: "ResMed’s magnetic clips are compliant with safety guidelines for magnetic field exposure levels for public use. For patients who have active medical implants, such as pacemakers or implantable defibrillators, it is recommended that the clips be kept at least 2 inches (50 mm) away from implants to avoid any potential interference. The magnetic clips are not suitable for use in cases where patients have a metallic hemostatic clip implanted in the head to repair an aneurysm, or a metallic splinter in one or both eyes."
And the warnings I've seen for Pjilips state similar (from an online store that hasn't updates yet)
"THIS PRODUCT CONTAINS MAGNETS and may not be suitable for anyone with an implanted medical device such as a pacemaker or defibrillator. If you have one of these devices, please keep the magnets at least 50mm away from these implanted devices."
Philips is changing that to 6" and listing a bunch of devices, but the old warning was the same as ResMed's.
RE: Philips again!
I think most wearers of the N20, specifically, would have to work very hard to get one of those magnets next to their pacemaker. The chin would have to be rotated left/right by at least 70 deg, and the head would have to be inclined severely, painfully, toward the pacemaker embedded in the chest wall. I'm not saying it could not be done, but it would be difficult to stay asleep, or to continue to maintain that head posture for more than three or four seconds.
RE: Philips again!
(09-07-2022, 06:38 AM)Gideon Wrote: What is PR doing? I think that inlight of their CPAP recall, which has significantly hurt them, that they did a risk evaluation across all their products, at least their CPAP related products, and are in the process of removing that threat. Note that the original warnings only warned of the CPAP patient having a pacemaker. This warning is about people around the Pacemaker patient wearing the magnet headgear.
They are protecting what is left of the company.
The warnings I've seen did mention defibrillators.
But this is due to 14 complains from 17 million devices. Most vaccines have a higher rate of adverse side effects.
RE: Philips again!
(09-07-2022, 02:59 PM)ST Dog Wrote: The warnings I've seen did mention defibrillators. (no edit option...)
For example this manual from 2017 for the Wisp
https://www.documents.philips.com/doclib...or_Use.pdf
on page 2
If your mask contains magnetic headgear clips, the following warnings apply:
• The headgear clips contain magnets. Contact your healthcare professional before you use this mask.
• Some medical devices may be affected by magnetic fields. The magnetic clips in this mask should be kept at least 2 in. (50 mm) away from any active medical device with special attention to implanted devices such as pacemakers, defibrillators and cochlear implants.
• Do not use in or near magnetic resonance imaging (MRI) equipment.
• Keep unassembled magnetic headgear clips out of reach of children. In case of accidental swallowing, seek medical assistance immediately
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