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1. Contraindications

  • Do not use this device if you are using a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic devices. Such use could cause electric shock, electrical interference, or death.

2. Warnings

  • Do not allow children to swallow or ingest accessories or detachable parts.
  • Do not use this device across or through your chest because the electrical currents introduced into the chest may cause rhythm disturbances to your heart, which may be lethal.
  • Do not use this device if you are susceptible to rhythm disturbances to the heart unless under the direction of your physician.
  • Do not use this device over your eyes, mouth, face, front of neck (especially in the carotid sinus), head, or across your heart because this could cause severe muscle spasms resulting in closure of your airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
  • Consult with your physician before using this device if you are in the care of a physician.
  • Consult with your physician before using this device if you have had medical or physical treatment for your pain.
  • Stop using this device and consult your physician if your pain does not improve, becomes more than mild, or continues for more than five days.
  • Do not use this device while driving, operating machinery, or during any activity in which electrical stimulation can put you at risk of injury.
  • Do not use this device over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g. phlebitis, thrombophlebitis, varicose veins).
  • Do not use this device over, or in proximity to, cancerous lesions.
  • Do not use this device on children because it has not been evaluated for pediatric use.
  • Do not use this device in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when the electrical stimulation device is in use.
  • Do not use this device when in the bath, shower or other sources of moisture.
  • Do not use this device while sleeping.
  • Do not use this device on abnormal skin, or skin that is not intact,clean, or healthy.
  • Do not operate in close proximity (e.g. 1 m) to shortwave or microwave therapy equipment as it may produce instability in the stimulator output.

3. Precautions

  • Do not start stimulation of the device prior to application of the device.
  • Keep this device out of the reach of children.
  • Do not use this device during pregnancy.
  • This device should not be applied on or across your head or face since the effects of stimulation of the brain are unknown.
  • This device is for symptomatic treatment and, as such, suppresses the sensation of pain that would otherwise serve as a protective mechanism.
  • If you have suspected or diagnosed heart disease, you should follow precautions recommended by your physician.
  • If you have suspected or diagnosed epilepsy or experience convulsions, you should follow precautions recommended by your physician.
  • Use this device with caution if you tend to bleed internally, such as following an injury or fracture.
  • Consult with your physician prior to using this device after a recent surgical procedure, because stimulation may disrupt the healing process.
  • Do not use this device for pain of central origin, including headache.
  • This device does not provide curative value.
  • The long-term effects of nerve stimulation are unknown.
  • You may experience skin irritation or hypersensitivity due to the electrical stimulation or adhesive medium (gel pads).
  • Use this device with caution if stimulation is applied over the menstruating or pregnant uterus.
  • Use this device with caution if stimulation is applied over areas of skin that lack normal sensation.
  • Use this device only with the gel pads and accessories recommended by the manufacturer.
  • Do not remove this device from your skin with the stimulation mode of operation activated.
  • Do not place your finger, or any object, between or near your skin and the adhesive gel pads during stimulation treatment.
  • This device is not to be used in the presence of flammable or anesthesia gasses or liquids.
  • Do not allow young children, pets, or pests contact with the device as alterations to the device may compromise product safety and/or performance.
  • Handle the unit with care. Inappropriate handling of the unit may adversely affect its characteristics.

4. Adverse Reactions

  • Skin irritations or burns may occur in the area where the electrode gel pad is applied.
  • Stop using the device or consult with your physician if you experience adverse reactions from the use of this device.