Specifications
Document Doc.Id. Version
Name of document GR 21-005 01
- Having an active, implanted medical device (e.g. cardiac pacemaker, spinal cord
stimulator, vagal nerve stimulator, auricular stimulator, deep-
brain stimulating
electrodes, cochlear implant, implanted hearing aid or defibrillator) or other implanted
metallic or electronic device.
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 environments 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: If you
experience a significant
worsening of your
symp
t
oms while using this device, consult a
physician
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.
- Discontinue treatment if the sensation of tingling, itching or burning under electrodes
becomes severe (mild sensation of tingling, itching or burning is normal).
Template Doc.Id. Version
Core Text Template FL 09-04-01 TMP 03