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Safety Information - Vitality Smartcable

SAFETY

The Nemechek Technologies Vitality Smartcable connects to your phone to deliver non-invasive electrical stimulation to the left ear. Micro pulses of electrical current are sent through the specially designed ear clip electrode.

WARNINGS AND PRECAUTIONS

  • Read the user guide that is enclosed with the product to ensure your proper use of the Smartcable.
  • STOP USE if you believe you are ill or believe you might be developing a new medical problem.
  • Do not wrap the lead wire around the neck- keep out of the reach of children.
  • Keep the Smartcable away from water, steam or other liquids.
  • Do not pull on the cord to remove the Smartcable from phone connector/adaptor. Only disconnect by gripping on the plug directly.
  • Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions.
  • Use this Smartcable only with the electrode ear clip provided.
  • Operation in close proximity (e.g. 3 feet) to therapeutic shortwave or microwave equipment may produce instability in the stimulator output.
  • The long-term effects of the chronic use of the Smartcable have not been evaluated.
  • Store the Smartcable a safe location out of reach of children.
  • Do not place the unit close to excessive heat.
  • Contact your healthcare provider if symptoms worsen.

INDIVIDUALS WITH KNOWN HEALTH ISSUES

The Smartcable is not being sold to treat any particular medical condition, and has not been tested for safety in any chronic medical condition such as including, but not limited to these examples:
  • Individuals with an active implantable medical device, such as a cardiac pacemaker, hearing aid or hearing implant, or any implanted metallic or electronic device.
  • Individuals with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years).
  • Individuals with diagnosed bradycardia or an irregular heart rhythm.
  • Individuals who have had surgery to cut the vagus nerve in the neck (cervical vagotomy).
  • Individuals with neurological conditions such as Alzheimer's dementia, Parkinson's ataxia or epilepsy.
  • Individuals diagnosed with narrowing of the arteries (carotid atherosclerosis).
  • Individuals whose pain syndromes are undiagnosed.
  • Pregnant women or women who suspect they might be pregnant.

Do not use the Vitality Smartcable in any children under the age of 18 years without obtaining permission from a physician, and never use in any child under the age of 5 years.

POTENTIAL RISKS AND COMPLICATIONS

  • The Smartcable poses very low risk when used in accordance with the instructions for use. No serious adverse events have been reported with similar products or in the scientific literature. If you experience any side effects from product use, stop treatment immediately.
  • If in you are concerned about any potential side effects, contact your healthcare provider immediately, do not contact Nemechek Technologies, LLC. Do not contact Nemechek Technologies, LLC with any medical questions or if seeking medical advice.

PRODUCT MALFUNCTION

  • Do not attempt to repair or modify the device. There are no user serviceable parts. If the device is not working, contact Nemechek Technologies at support@nemechektech.com.

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