3
• Do not use the device over twice a day on the same place of your lower back.
• Caution should be used with the following conditions:
- Have had a recent surgical procedure where muscle contraction may disrupt the
healing process.
- Over areas of the skin that lack normal sensation.
• Gel pad placement and stimulation settings should be based on the guidance of
the Instruction Manual.
• The long-term effects of electrical stimulation are currently unknown but is rapidly
advancing.
• The device may cause lethal rhythm disturbances to the heart in susceptible
individuals.
• Device is ineffective for pain of central origin, including headaches.
• This device has no curative value; it is a symptomatic treatment and as such
suppresses the sensation for pain which would otherwise serve as a protective
mechanism on the outcome of clinical process.
• Electronic equipment such as EKG monitors and ECG alarms may not operate
properly when device is in use.
• The user must keep the device out of the reach of children.
• Stimulus delivered by this device may be sufficient to cause electrocution or burn
and it may cause a cardiac arrhythmia.
• Possible allergic reaction to tape or gel may exist. Possible skin irritation
and electrode burns are potential adverse reactions. If skin irritation persists,
discontinue use and consult your physician.
• Apply stimulation only to normal, intact, clean, healthy skin.
• If your pain does not improve, becomes more than mild, or continues for more
than five days, stop using the device and consult with your physician.
• Not for use by or on persons under the age of 18 years old.
• Stop using this device if you experience a tingling or numbing sensation, or other
discomfort on the skin.
Do not use if you,
• Have pacemaker, metal implant, insulin pump or any other implant in the body.
• For patients with known myocardial disease or arrhythmia, the device should be
used only with consultation and evaluation by a specialized physician.
• Do not apply any electrode placement that causes current to flow through the
head.
• Do not use device on the eyelids. Do not place electrodes directly over the carotid
sinus nerves or arteries, and laryngeal or pharyngeal muscles.
• Do not apply device for undiagnosed pain syndromes until etiology is established.
