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6. Warnings
• Apply the headset ONLY on the head as directed and not
on other body parts.
• Keep the headset dry and out of sunlight.
• Keep the headset out of the reach of children.
• Do not apply the headset over areas of skin that lack
normal sensations.
• Do not apply the headset outdoors or close to water.
• Do not apply the headset while driving.
• Do not apply the headset during any activity creating a
significant risk of injury.
• Do not apply the headset while intoxicated or
incapacitated.
• Do not apply the headset in an environment with strong
magnetic fields.
• Do not apply the headset without the supplied Headset
Pads.
• Do not apply the headset with dried-out Headset Pads
(Pads are single use).
• Do not charge the headset with any other charger than
the one supplied with the Headset.
• Worsening of symptoms: Patient MUST consult a
physician if he/she experiences a significant worsening of
depression while using this device before continuing the
treatment.
7. Possible Adverse Reactions
• Some skin redness under the electrode or near the
electrode sites is normal, due to increased local blood
flow, and will normally subside within approximately an
hour of the end of use.
• DO NOT apply the device over open wounds,
or broken or damaged skin. This might create further
irritation and/or skin damage.
• Skin irritation might be experienced beneath the
stimulation electrodes. In this case, electrodes should
NOT be reapplied to the irritated skin.
• have open wounds, or broken or damaged skin at the
stimulation site (this might create further irritation and/
or damaged skin).
• are pregnant or may be pregnant.
• have a pre-existing neurological or neuropsychiatric
condition.
• have an active implanted medical device such as a
cardiac pacemaker or neurostimulation device such as a
spinal cord stimulator, vagal nerve stimulator, auricular
stimulator, or deep-brain stimulating electrodes, or
implanted defibrillator, or other implanted metallic or
electronic devices.
• have a defect in the neurocranium, an implant inside the
skull, a cochlear implant, or an implanted hearing aid.
• are suspected of having or have been diagnosed with
heart disease.
• have recently had a surgical procedure.
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