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1.4 Contraindications
1) This device should not be used for symptomatic local pain
relief unless etiology is established or unless a pain syndrome
has been diagnosed.
2) This device should not be used when cancerous lesions are
present in the treatment area.
3) Stimulation should not be applied over swollen, infected,
inflamed areas or skin eruptions (e.g. phlebitis, thrombophlebitis,
varicose veins, etc.).
4) Electrodes must not be applied to sites that might cause
current/stimulation to flow through the carotid sinus region
(anterior neck) or transcerebrally (through the head).
5) Do not use this device if the patient has a demand-type
cardiac pacemaker or any implanted defibrillator.
6) This device should not be used over poorly enervated areas.
7) This device should not be used on patients with epilepsy.
8) This device should not be used on patients with serious
arterial circulatory problems in the lower limbs.
9) This device should not be used on patients with abdominal or
inguinal hernia.
10) Do not use this device if you have heart disease without
consulting your physician.
1.5 Warnings, Cautions and Adverse Reactions
WARNINGS:
1) This device should be used only under the continued
supervision of a licensed physician.
2) The long-term effects of chronic electrical stimulation are
unknown. Electrical stimulation devices do not have any
curative value.
3) TENS is a symptomatic treatment and, as such, suppresses
the sensation of pain, which would otherwise serve as a
protective mechanism.
4) Safety has not been established for the use of therapeutic
electrical stimulation during pregnancy. Do not use during
pregnancy unless directed by your physician.
5) Electrical stimulation is not effective for pain of central origin, such
as headache.
