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White Waves

Updated
Contraindication & Warning

ResMed Masks with Magnets - Potential Magnetic Interference
with Certain Medical Devices

English

     ATTENTION


The information in this addendum provides important updates to the
Contraindications and Warnings found in the mask User Guide.
 

Contraindication


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)


    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.

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Bahasa Melayu

    PERHATIAN


Maklumat dalam adendum ini menyediakan kemas kini penting kepada
Kontraindikasi dan Amaran yang terdapat dalam Panduan Pengguna
topeng.


Kontraindikasi


Topeng dengan komponen magnet tidak sesuai digunakan oleh pesakit
di mana mereka, atau sesiapa sahaja yang berada dalam hubungan fizikal rapat semasa menggunakan topeng, mempunyai perkara berikut:

• lmplan perubatan aktif yang berinteraksi dengan magnet (iaitu,
perentak jantung, defibrilator kardioverter boleh implan (ICD),
neurostimulator, pirau cecair serebrospina (CSF), pam insulin/infusi)
• lmplan/objek logam yang mengandungi bahan feromagnetik (iaitu, klip
aneurisme/peranti gangguan aliran, gegelung embolik, stent, injap,
elektrod, implan untuk memulihkan pendengaran atau keseimbangan
dengan magnet yang diimplan, implan okular, serpihan logam di mata)

    AMARAN


Pastikan magnet pada jarak selamat sekurang-kurangnya 6 inci
(150 mm) dari implan atau peranti perubatan yang mungkin terjejas
akibat gangguan magnetik. Amaran ini terpakai kepada anda atau
sesiapa sahaja yang berada berdekatan dengan topeng anda.
Magnet berada dalam bingkai dan klip alat kepala bahagian bawah,
dengan kekuatan medan magnet sehingga 400mT. Apabila dipakai,
ia bersambung untuk melindungi topeng tetapi mungkin tertanggal
secara tidak sengaja semasa tidur.
lmplan/peranti perubatan, termasuk yang disenaraikan dalam
kontraindikasi, mungkin terjejas jika ia menukar fungsi di bawah
medan magnet luar atau mengandungi bahan feromagnetik yang
menarik/menolak medan magnet (sesetengah implan logam, cth.,
kanta sentuh dengan logam, implan gigi, plat kranial logam, skru,
penutup lubang gerigi dan peranti pengganti tulang). Rujuk doktor
anda dan pengilang implan / peranti perubatan anda yang lain untuk
maklumat tentang potensi kesan buruk medan magnet.

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acknowledgement

By submitting the provided data, I affirm that I have read and comprehended the updated contraindication, warnings, and The Air Station data protection policy. I hereby grant consent to The Air Station Sdn Bhd for the collection, use, and disclosure of my personal data in accordance with the provisions of the Personal Data Protection Act 2010.

We strive to continuously review our adherence to changes in the Personal Data Protection Act (PDPA), and take all necessary steps to ensure utmost security and protection to your personal data. Read the full privacy policy document from our website (https://www.theairstation.com.my/policy) for more information

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