IFU-001 Rev D June 2014
FDA 510(k) Cleared
1. Symptomatic relief of chronic intractable pain.
2. Post traumatic pain.
3. Post surgical pain.
Contraindications
1. Do not use this device on patients who have a cardiac pacemaker, implanted
Defibrillator or other implanted metallic or electronic device, because this may
cause electric shock, burns, electrical interference, or death.
2. Do not use this device on patients whose pain syndromes are undiagnosed.
Precautions
1. Transcutaneous electrical neuro stimulation is not effective for pain of central origin, including
headache.
2. Transcutaneous electrical neuro stimulation is not a substitute for pain medications and other pain
management therapies.
3. Transcutaneous electrical neuro stimulation devices have no curative value.
4. Transcutaneous electrical neuro stimulation is a symptomatic treatment and, as such, suppresses the
sensation of pain that would otherwise serve as a protective mechanism.
5. Effectiveness is highly dependent upon patient selection by a practitioner qualified in the management
of pain patients.
6. The long-term effects of electrical stimulation are unknown.
7. Since the effects of stimulation of the brain are unknown, the unit’s electrodes should not be applied
anywhere on the head.
8. The safety of electrical stimulation during pregnancy has not been established.
9, Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or
electrical conductive medium (gel).
10. Patients with suspected or diagnosed heart disease and epilepsy should follow precautions
recommended by their physicians.
11. Care should be taken so that when operating potentially dangerous machinery, the stimulator
controls are not changed abruptly.
Cautions
1. Use caution when the patient has a tendency to bleed internally, such as following an injury or
fracture.
2. Use caution following rece
nt surgical procedures when stimulation may disrupt the patient’s healing
process.
3. Use caution if stimulation is applied over the menstruating or pregnant uterus.
4. Use caution if stimulation is applied over areas of skin that lack normal sensation.
5. Keep this device out of the reach of children.
6. Use this device in accordance with this instruction manual.
7. Use this device only under the continued supervision of a licensed practitioner.
