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SAFETY PRECAUTIONS

Read all instructions, warnings, and precautions as well as the Owner’s Manual before using the device. It should be used only for the purpose for which it is intended. Data presented has not been reviewed and evaluated by the FDA. Devices are not intended for diagnosis or treatment of disease condition.

Danger

The device can generate output pulses up to 650 volts. To avoid skin irritations such as burns, do not use device for prolonged periods of time in a single location, while sleeping, or other unattended use. Misuse could result in fire hazard.

Contra-indications

Do not use on anyone with a demand-type cardiac pacemaker or other implanted electronic devices or who may be pregnant.

Precautions

Skin irritation and electrode burns have been reported at the site of electrode placement following long-term application. To reduce risk of skin burns, keep electrodes directly against skin during application.

  • Effectiveness is highly dependent upon subject selection by a person qualified in the management of pain.
  • Do not use the device on those who may be under the influence of alcohol or other drugs, on the eyeball or over the vessels that may contain a blood clot.
  • Do not use device for undiagnosed pain syndromes until etiology is established.
  • Caution should be used for persons with suspected or diagnosed heart problems.
  • Caution should be used for persons with suspected or diagnosed epilepsy.
  • Caution should be used in the presence of the following:
    • When there is a tendency to hemorrhage
    • After acute trauma or fracture
    • Following recent surgical procedures when muscle contraction may disrupt the healing process
    • Over the menstruating or pregnant uterus
    • Over areas of the skin which lack normal sensation
  • Some people may experience skin irritation or hypersensitivity because of electrical stimulation or electrical conductive medium. The irritation usually can be reduced by using an alternate conductive medium (electrode) or different electrode placement, or reduced output power.
  • Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner.
  • Results may be influenced by person's psychological state and use of drugs.

Warnings

  • Device is a symptomatic treatment and as such may suppress the sensation of pain that would otherwise serve as a protective mechanism.
  • The long-term effects of chronic electrical stimulation are unknown.
  • Stimulation should not be applied over the carotid sinus nerves or artery. Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur, and the contractions may be strong enough to close the airway or cause difficulty in breathing.
  • Do not place electrode pads on broken or damaged skin. Do not place electrode pads over the front or side of the neck, close to eyes or in the mouth.
  • Stimulation should not be applied trans-thoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmia.
  • Do not allow any electrode placement that applies current flow trans-cerebrally (through the head).
  • Stimulation should not be applied over swollen, infected, or inflamed areas or skin eruptions such as phlebitis, thrombophlebitis, varicose veins, etc.
  • Stimulation should not be applied over, or in proximity to, cancerous lesions.
  • Keep device out of reach of children. It is not a toy. It should not be used as a weapon.
  • Device is not a life-saving device.
  • Do not use in or near water.
  • Do not use while operating machinery or vehicles.
  • Do not use the unit if it has been dropped and does not operate properly. Do not use if the case is damaged.
  • Electronic monitoring equipment, such as ECG monitors and ECG alarms, may not operate properly when using Avazzia device for microcurrent. The microcurrent electro-pulses may interfere with pacemakers and/or other electronic and radiological equipment.
  • See also Troubleshooting.