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4 Contraindications, Warnings and Precautions
Precautions
Caution – Keep Optune®out of the reach of children. If children touch the device, they could damage the device. This
could cause a break in treatment. Breaks in treatment may lower your chance to respond to treatment.
Caution – Do not use any parts that do not come with the Optune Treatment Kit, or that were not sent to you by the
device manufacturer or given to you by your doctor. Use of other parts, manufactured by other companies or for use
with other devices, can damage the device. This may lead to a break in treatment. Breaks in treatment may lower your
chance to respond to treatment.
Caution – If your doctor used plates or screws to close your skull bone during your surgery, be careful when placing
the transducer arrays. Make sure the round disks that make up the transducer arrays are not on top of the areas where
you can feel the screws or plates under your skin. In other words, make sure the screws or plates under your skin are in
between the round disks that make up the transducer arrays.
If you do not do this, you may have increased skin damage which may lead to a break in treatment. Breaks in treatment
may lower your chance to respond to treatment.
Caution – Tell your doctor before using the device if you have an inactive implanted medical device in your brain (such
as a stent, plastic drug delivery reservoir, aneurysm clip or coil or device lead). Use of Optune in subjects with inactive
implanted medical devices in their brain was not tested and could lead to tissue damage or lower your chance to
respond to treatment.
Caution – Do not use Optune if any parts look damaged (torn wires, loose connectors, loose sockets, cracks or breaks
in the plastic case). Use of damaged components can damage the device, and cause a break in treatment. Breaks from
treatment may lower your chance to respond to treatment.
Caution – Do not wet the device or transducer arrays. Getting the device wet may damage it, preventing you from
receiving treatment for the right amount of time. Getting the transducer arrays very wet is likely to cause the transducer
arrays to come loose from your head. If this happens, the device will turn o and you will need to change the
transducer arrays.
Caution – Before connecting or disconnecting the transducer arrays, make sure that the Optune power switch is in the
OFF position. Disconnecting transducer arrays with the device power switch in the ON position may cause a device
alarm to go o, and could damage the device.
Caution: If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may
prevent or temporarily interfere with Optune treatment.
Notices
Notice! The Optune device and transducer arrays will activate metal detectors.
Notice! Do not use Optune if your tumor is located in the lower parts of the brain close to the spinal cord. Ask your
doctor if your tumor is located in this part of your brain. Optune has not been tested in patients with tumors in these
locations. It is unknown whether these tumors will respond to treatment.
Notice! You should use Optune for at least 18 hours a day to get the best response to treatment. Using Optune for
less than 18 hours a day lowers the chances that you will respond to treatment.
Notice! Do not stop using Optune before you finish at least four full weeks of therapy to get the best response to
treatment. Stopping treatment before four weeks lowers the chances that you will respond to treatment.
Notice! Do not stop using Optune even if you have used it less than the recommended 18 hours per day. You should
stop using the device only if your doctor tells you to. Stopping treatment could lower the chances that you will respond
to treatment.
Contraindications, Warnings and Precautions
