novocure Optune NovoTTF 200A, User Manual

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Contraindications, Warnings & Precautions
CONTRAINDICATIONS
Do not use Optune Treatment Kit if you are pregnant, think you might be pregnant, or
are trying to get pregnant. If you are a woman who is able to get pregnant, you must
use birth control when using the device. Optune Treatment Kit was not tested in
pregnant women.
Do not use Optune Treatment Kit if you have significant additional neurological
disease (primary seizure disorder, dementia, Progressive degenerative neurological
disorder, Meningitis or encephalitis, Hydrocephalus associated with increased
intracranial pressure)
Do not use Optune Treatment Kit if you are known to be sensitive to conductive
hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous
electrical nerve stimulation (TENS) electrodes. In this case, skin contact with the gel
used with Optune Treatment Kit may commonly cause increased redness and itching,
and rarely may even lead to severe allergic reactions such as shock and respiratory
failure.
Do not use Optune if you have an active implanted medical device, a skull defect
(such as, missing bone with no replacement) or bullet fragments. Examples of active
electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve
stimulators, pacemakers and defibrillators. Use of Optune together with implanted
electronic devices has not been tested and may lead to malfunctioning of the
implanted device. Use of Optune together with skull defects or bullet fragments has
not been tested and may possibly lead to tissue damage or render Optune ineffective.