2.3. Safety Information
IMPORTANT NOTE: Use the device only as instructed
by Valkee, to avoid potential personal injury or
damage to the device. Read all warnings and
cautions before using the device.
The device has CE Class I medical device
certification and has been clinically tested. The
device meets the requirements of the Medical
Device Directive 93/42/EEC.
Contraindications
The device is not intended for person with
depression, anxiety, person with antidepressant
medication or person who has or has had suicidal
thoughts or has ever tried to hurt others or
themselves.
The device is not intended for children or for use
during pregnancy.
The device may not be suitable for individuals who
suffer from bipolar disorder. Side effects of use
of the device are rare when the instructions for
appropriate use are followed. The most common
side effects that have been reported in our
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