(3)
over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g., phlebitis, thrombophlebitis, varicose veins). Apply stimulation only to
normal, intact, clean, healthy skin;
(4)
in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG
alarms). The electronic stimulator may not operate properly when the electrical
stimulation device is in use;
(5)
while operating machinery, or during any activity in which electrical stimulationcan
put you at risk of injury;
(6)
on children.
Be aware of the following.
(1)
consult with your physician before using this device. The simulation with thedevice
may:
i.
cause lethal rhythm disturbances to the heart in susceptible individuals,and,
ii.
disrupt the healing process after a recent surgical procedure;
(2)
that the device is not effective for pain of central origin, including headaches;
(3)
that the device is not a substitute for pain medications and other painmanagement
therapies;
(4)
that the device has no curative value;
(5)
that the device is a symptomatic treatment and, as such, suppresses thesensation
of pain that would otherwise serve as a protectivemechanism;
(6)
that the long-term effects of electrical stimulation areunknown;
(7)
that the user may experience skin irritation, burns or hypersensitivity due to the
electrical stimulation or electrical conductive medium;
(8)
if the user has suspected or diagnosed epilepsy, the user should followprecautions
recommended by his or her physician;
(9)
to use caution if the user has a tendency to bleed internally, such as followingan
injury or fracture;
(10)
use caution if stimulation is applied over the menstruatinguterus;
(11)
use caution if stimulation is applied over areas of skin that lack normalsensation;
(12)
stop using the device if the device does not provide pain relief;and,
(13)
use this device only with the leads, electrodes, and accessories thatthe
manufacturer recommends.
Medical Electrical Equipment needs special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according to the EMC
information provided. Portable and mobile radio frequency (RF) communication
equipment can affect Medical Electrical Equipment.
Environmental condition for transport and storage:
Easily fragile product
Keep the product in a dry place away from water and rain.
