6
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 Professional
TM
can't be placed
over the carotid sinus (upper side of neck) region. The electrodes/gloves
of MEND Professional
TM
can't be placed over regions through which
current will flow transcerebrally (through the head). MEND
Professional
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 Professional
TM
should be used only under the continued
supervision of a licensed health care practitioner. The MEND
Professional
TM
has no curative value. The MEND Professional
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 Professional
TM
is in
use.
The MEND Professional
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 Professional
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
