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2.2 Warnings, Cautions and Adverse Reactions
WARNINGS:
1. This device should be used only under the continued supervision
of a licensed physician or practitioner.
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 a headache.
6. Electrical monitoring equipment (such as ECG monitors and ECG
alarms) may not operate properly when electrical stimulation is in use.
7. Stimulation should not be applied over the carotid sinus nerves,
particularly in patients with a known sensitivity to the carotid sinus reflex.
8. Stimulation should not be applied over the neck or mouth. Severe
spasm of the laryngeal and pharyngeal muscles may occur and the
contraction may be strong enough to close the airway or cause
difficulty in breathing.
9. Stimulation should not be applied transthoracically. Introduction of
electrical current into the heart may cause cardiac arrhythmias.
10. Stimulation should not take place while the user is connected to
high-frequency surgical equipment, it may cause burn injuries on
the skin under the electrodes, as well as problems with the stimulator.
11.
DO NOT
use the stimulator in the vicinity of shortwave or microwave
therapy equipment, since this may affect the output power of the
stimulator.
12.
NEVER
use in environments with high humidity such as in the
bathroom or when having a bath or shower.
13. Caution should be used in applying electrical stimulation to
patients suspected of having heart disease. Further clinical data is
needed to show there are no adverse results.
14.
NEVER
use near the heart. Stimulation electrodes should
NEVER
be
placed anywhere on the front of the thorax (marked by ribs and
breastbone), take extreme caution not to place near or on the
two large pectoral muscles. Here it can increase the risk of
ventricular fibrillation and lead to cardiac arrest.
15. Electrodes should not be placed over the eyes, in the mouth, near
the genitals or internally.