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III. Warnings and Cautions
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7. Caution should be used for patients with suspected or diagnosed
heart problems.
8. Caution should be used when operating the device over the
abdominal region during menstruation periods.
9. Caution should be used when applying the device over areas of
the skin that lack normal sensation.
10. Stimulation should not be applied when in the bath or shower.
11. Do not use the device in a humid atmosphere (sauna,
hydrotherapy, etc.).
12. Electrodes should be applied only to normal, intact, clean skin.
Electrodes should not be applied over open wounds or over
swollen, infected, or inflamed areas or skin eruptions (e.g.,
phlebitis, thrombophlebitis, varicose veins, etc.).
13. Electrodes should not be shared with other persons. Each person
should have their own set of electrodes; otherwise, undesirable
skin reactions may occur.
14. Self-adhesive electrodes should be replaced if they no longer
stick firmly to the skin.
Precautions
1. Some persons may experience skin irritation or hypersensitivity
due to the electrical stimulation or electrical conductive medium
(gel).
2. This device should be kept out of the reach of children.
3. This device should be used only with the leads, electrodes, and
accessories recommended for use by the manufacturer.
Adverse Reactions
1. Skin irritation and burns beneath the electrodes have been
reported with the use of stimulation electrodes applied to the skin.
2. Headache and other painful sensations have been reported
during or following the application of electrical stimulation
applied to the head, face, and near the eyes.