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WARNING: Do not place electrodes over the carotid sinus nerves, particularly
in patients with a known sensitivity to the carotid sinus reflex.
WARNING: Do not place electrodes over the neck or mouth. This may result in
spasms of the laryngeal and pharyngeal muscles, and the contraction may be
strong enough to close the airway or cause difficulty in breathing.
WARNING: Do not apply stimulation transthoracically, because the introduction
of electrical current into the heart may cause cardiac arrhythmia.
WARNING: Do not apply stimulation transcerebrally.
WARNING: Do not apply stimulation over swollen, infected or inflamed areas or
skin eruptions; e.g. phlebitis, thrombophlebitis, varicose veins, etc.
WARNING: Do not apply stimulation over or in proximity to cancerous lesions.
WARNING: The safety of the device during pregnancy or delivery has not been
established.
WARNING: Caution should be used for patients with suspected or diagnosed
heart problems.
WARNING: Caution should be used when applying this device to patients sus-
pected of having heart disease. Further clinical data is needed to show if there
are adverse side effects on individuals with heart disease.
WARNING: Caution should be used for patients with suspected or diagnosed
epilepsy.
WARNING: Caution should be used in the presence of the following:
When there is a tendency to hemorrhage following acute trauma or fracture;
Following recent surgical procedures when muscle contraction may disrupt the
healing process;
Over the menstruating or pregnant uterus; and
Over areas of the skin which lack normal sensation.
