3
Warnings and Precautions
(continued)
• The device is not effective for headaches.
• 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 those with heart disease.
• The device may interfere with electronic monitoring equipment (such as ECG
monitors and ECG alarms).
• Electrodes should not be placed over the eyes, in the mouth, or internally.
• This device has no curative value. The TENS unit provides a symptomatic treatment that
suppresses the sensation of pain which would otherwise serve as a protective mechanism.
• TENS devices should be used only under the continued supervision of a physician or
licensed practitioner.
• Do not use on broken skin.
• Treatment effectiveness is highly dependent upon instruction from a person qualified
in pain management using TENS.
• If the device treatment becomes ineffective or unpleasant, stimulation should be
discontinued until re-evaluation by a physician or licensed practitioner.
• Always turn the device off before applying or removing electrodes.
• The device does not have AAP/APG protection. An explosion hazard is possible if
used in the presence of explosives, flammable materials or flammable anesthetics.
Adverse Reactions
Skin irritation and electrode burns are potential adverse reactions. Stimulation should
be stopped and electrodes removed until the cause of the irritation or burns can be
determined. Isolated cases of skin irritation may occur at the site of electrode placement
following long-term application. Always properly clean skin before use. If skin irritation
occurs, discontinue use. Do not resume use of the BodyMed
®
TENS unit until you have
seen your physician or licensed practitioner.
