•
Any electrode placement which causes current to flow transcerebrally
(through the head).
•
The use of unit whenever pain symptoms are undiagnosed and the
etiology 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 having 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.
WARNING: The device may interfere with electronic monitoring equipment
(such as ECG monitors and ECG alarms).
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