7
Safety of microcurrent stimulation has not been established during pregnancy
or birth. Microcurrent stimulation is not effective for pain of central origin
including headache.
WARNINGS
The electrodes or gloves of the MEND Wellness
TM
can't be placed over the
carotid sinus (upper side of neck) region. The electrodes/gloves of MEND
Wellness
TM
can't be placed over regions through which current will flow
transcerebrally (through the head). MEND Wellness
TM
should not be used on
patients whose pain syndromes are not diagnosed and etiology is not established.
If another garment electrode is used as a dispersive electrode, placement of the
dispersive electrode should ensure transthoracic stimulation is not possible.
The MEND Wellness
TM
should be used only under the continued supervision of
a licensed health care practitioner. The MEND Wellness
TM
has no curative value.
The MEND Wellness
TM
is a symptomatic treatment and as such suppresses the
sensation of pain which could otherwise serve as a protective mechanism.
The electrodes should not be placed over or in proximity of cancerous lesions,
infected or inflamed areas of the skin with open lesions.
Do not allow children to use or handle this device.
Do not operate vehicles or potentially dangerous machinery during periods of
stimulation.
Electronic monitoring equipment such as ECG monitors and ECG alarms may
not operate properly when The MEND Wellness
TM
is in use.
The MEND Wellness
TM
is not a life-saving device.
PRECAUTIONS
Isolated cases of skin irritation may occur at the site of conductive materials
following long-term application. The effectiveness of the MEND Wellness
TM
device is highly dependent upon patient selection by a practitioner qualified in
the management of pain. Electrode placement and stimulation settings should
be based on the guidance of the prescribing practitioner. Patients should not use
the device while under the influence of alcohol, controlled substances or
