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• Electrosurgical equipment or defibrillators.
Disconnect the stimulation electrodes be-
fore using electrosurgical equipment or
defibrillators. Otherwise skin burns may be
caused below the electrodes and the de-
vice might be destroyed.
• Magnetic Resonance Imaging. Do not
wear electrode or the device during
Magnetic Resonance Imaging (MRI) scans
as this may result in metal overheating
and causing skin burns in the area of the
electrode.
• Flammable or explosive environment. Do
not use the device in areas where there is
a risk of fire or explosion, such as oxygen-
rich environments, in the vicinity of flam-
mable anaesthetics, etc.
• Power supply. Never connect stimulation
cables to an external power supply as
there is a risk of electric shock.
• Near other equipment. Do not use the de-
vice beside or stacked on top of any other
equipment. If you must use it side by side
or on top of another system, you should
check that the device works properly in
the chosen configuration.
• Miscellaneous. Electrodes for Single
Patient. Do not share electrodes with oth-
er persons. All users should have individual
set of electrodes to prevent undesirable
skin reactions or disease transmission.
• Accessories. Use this device only with the
leads, electrodes, and accessories recom-
mended by the manufacturer. Use of other
accessories may adversely affect the
performance of the device or may result in
stronger electromagnetic emissions or reduce
the electromagnetic immunity of the device.
• No Modification. No modification of the
equipment is allowed.
12.3. Precautions
• Supervision. Use this device only under the
continued supervision of a licensed practi-
tioner. Electrode placement and stimula-
tion settings should be based on the guid-
ance of the prescribing practitioner.
• Manufacturer. The manufacturer does not
take any responsibility for any electrode
placements other than recommended.
• Pregnancy. The safety of electrical stimula-
tion during pregnancy has not been estab-
lished.
• Skin irritation. Some patients may experi-
ence skin irritation or hypersensitivity due
to the electrical stimulation or electrical
conductive medium (gel). The irritation
may be reduced by using an alternate con-
ductive medium or alternate electrode
placement. Some patients may experience
redness under the electrodes after a ses-
sion. This redness usually disappears with-
in a few hours. Advise the patient to con-
sult the clinician if the skin redness does
not disappear after a few hours. Do not
start another stimulation session in the
same area if the redness is still visible.
Don't scratch the redness area.
• Heart Disease. Patients with suspected or
diagnosed heart disease should follow pre-
cautions recommended by their physicians.
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