TheraTouch® CX2/CX4/EX4
2
DANGER
DO NOT USE WITH THESE MEDICAL
DEVICES:
1.
Internally transplanted electronic
medical devices, such as a pacemaker.
2.
Electronic life support equipment,
such as respirators.
3.
Electronic medical devices attached to
the body, such as electrocardiographs.
Using this stimulator with other electronic
medical devices may cause erroneous
operation of those devices.
DO NOT
use other RF equipment near the
TheraTouch®.
DO NOT
use RFID systems near the
TheraTouch®.
DO NOT
use electrical stimulation in
conjunction with high frequency surgical
equipment or microwave or shortwave
therapy systems.
This device needs special precautions
regarding EMC and needs to be installed
and put into service according to the
EMC information provided on pages
42 – 45.
These devices are contraindicated for
use in an MRI environment and should
be removed prior to an MRI exam or MRI
exposure. Keep the device away from
strong magnetic fi elds. These devices are
MR unsafe.
WARNING
DO NOT USE THIS DEVICE UNDER THESE
CONDITIONS:
•
If a patient has a cardiac pacemaker,
implanted defi brillator, or other
implanted metallic or electronic device.
Such use could cause electric shock,
burns, electrical interference, or death.
•
Together with a life-supporting medical
electronic device such as an artifi cial
heart or lung or respirator.
•
In the presence of electronic monitoring
equipment (e.g., cardiac monitors,
ECG alarms), which may not operate
properly when the electrical stimulation
device is in use.
•
On open wounds or rashes, or over
swollen, red, infected, or infl amed
areas or skin eruptions (e.g., phlebitis,
thrombophlebitis, varicose veins); or
on top of, or in proximity to, cancerous
lesions.
•
Over areas of skin that lack normal
sensation.
•
DO NOT
use while patient is in bath or
shower.
•
DO NOT
use while patient is sleeping.
•
Patients with arterial or venous
thrombosis or thrombophlebitis are
at risk of developing embolisms when
electrical stimulation is applied over or
adjacent to the vessels containing the
thrombus. If a patient has a history of
deep vein thrombosis, even many years
past, the aff ected area should not be
stimulated.
•
Fresh fractures should not be stimulated
in order to avoid unwanted motion.
•
Stimulation should not be applied
immediately following trauma or
to tissues susceptible to hemorrhage.
DO NOT USE ON THESE INDIVIDUALS:
•
Pregnant women, because the safety of
electrical stimulation during
pregnancy has not been established.
•
Children or infants, because the
device has not been evaluated for
pediatric use.
•
Persons incapable of expressing their
thoughts or intentions.
ELECTRODE WARNINGS AND
PRECAUTIONS:
NEVER APPLY THE ELECTRODES TO:
•
The head or any area of the face. The
eff ects of stimulation of the brain are
unknown.
•
Any area of the throat because this
could cause severe muscle spasms
resulting in closure of the airway,
diffi
culty in breathing, or adverse eff ects
on heart rhythm or blood pressure.
•
Both sides of the thorax simultaneously
(lateral or front and back), or across the
patient’s chest because the introduction
of electrical current may cause rhythm
disturbances which could be lethal.
SAFETY PRECAUTIONS
