•
Any electrode placement which causes current to flow transcerebrally
(through the head).
•
The use of unit whenever pain symptoms are undiagnosed and the etiol-
ogy is unknown.
SAFETY
Always follow basic safety precautions, including the following:
WARNING: Indicates a potential hazard situation or unsafe practice that, if not
avoided, could result in death or serious personal injury.
s CAUTION: Indicates a potential hazard or unsafe practice that, if not avoided,
could result in minor personal injury or product / property damage.
Warnings
WARNING: Explosion hazard
Explosion hazard is possible if used in the presence of explosives, flammable
materials or flammable anesthetics.
WARNING: Heart disease
Caution should be used when applying the device to patients suspected of hav-
ing heart disease. Further clinical data is needed to show if there are adverse
side effects on individuals with heart disease.
WARNING: Keep this device out of the reach of children.
WARNING: The safety of the device during pregnancy or delivery has not been
established.
WARNING: Do not place electrodes on front of the throat. This may result in
spasms of the laryngeal and pharyngeal muscles.
WARNING: Do not place the electrodes over the carotid nerve.
WARNING: The device is not effective for pain of central origin (headaches).
WARNING: Avoid adjusting controls while operating machinery or vehicles.
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