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 at [email protected].
