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SAFETY
The Nemechek Technologies, LLC Vitality Smartcable connects to your phone to deliver non-invasive neuromodulation, harnessing the beneficial therapeutic mechanisms of stimulation. Micro pulses of electrical current are sent through the specially designed ear clip electrode.Electric neuromodulation is a therapeutic remedy with only minor side effects.
WARNINGS AND PRECAUTIONS:
· Read the user guide carefully to ensure proper use of the Vitality Smartcable.
· Do not wrap the lead wire around the neck - keep out of the reach of children.
· Keep Vitality Smartcable away from water, steam or other liquids.
· Do not pull on the cord to remove the device 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 device only with the electrode ear clip provided.
· Operation in close proximity (e.g. 1 m) to a shortwave or microwave therapy ME equipment may produce instability in the stimulator output.
· The long-term effects of the chronic use of the device have not been evaluated.
· Store your Vitality Smartcable a safe location out of reach of children.
· Do not place the unit close to excessive heat.
· Contact your healthcare provider if you have any questions regarding your health or symptoms you may be experiencing.
· Consult your healthcare provider before using on children under the age of 18. Do not use on children under the age of 5.
CONTRAINDICATIONS
Safety and efficacy of the Vitality Smartcable has not been evaluated in the following patients, and therefore it is not indicated for:
· Patients with an active implantable medical device, such as a cardiac pacemaker, hearing aid implant, or any implanted metallic or electronic device.
· Patients 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).
· Patients with diagnosed bradycardia or an irregular heart rhythm.
· Patients who have had surgery to cut the vagus nerve (vagotomy).
· Patients diagnosed with narrowing of the arteries (carotid atherosclerosis).
· Pregnancy or potential pregnancy.
Note: Do not attempt to repair or modify the device. There are no user serviceable parts. If the device is not working, contact Nemechek Technologies atsupport@nemechektech.com.
POTENTIAL RISKS AND COMPLICATIONS:
The Vitality Smartcable is very low risk when used in accordance with the instructions for use. No serious adverse events have been reported with its predecessor device or in the scientific literature. If you experience any side effects from device use stop treatment immediately. If in doubt, contact your healthcare provider.
A 2018 systematic review analyzed 1322 participants (across 51 studies) who received transcutaneous neuromodulation at the ear. The review found that only 2.6% of participants discontinued use due to side effects, where the most common side effect reported was skin irritation at the stimulation site which typically ceased shortly after use. The following side effects were reported in this review: Tingling/pain/redness/itching at the site of electrode placement during long term application (16.7%) Lightheadedness/dizziness (1.4%) Fatigue (0.5%) Shortness of breath (0.4%) Voice alteration/hoarseness (0.3%) Abnormal heart rhythm (0.3%) if in doubt contact your doctor. NOTE: this review analyzed studies using multiple different neuromodulation methodologies so the results cannot be extrapolated to the Vitality Smartcable and are included only as reference information.
