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• Miscellaneous. Electrodes for Single Patient. Do not share electrodes with other 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 recommended by the manufacturer. Use of other acces-
sories 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.
3.3. PRECAUTIONS
• Supervision. Use this device only under the continued supervision of a licensed practitioner. Electrode placement
and stimulation settings should be based on the guidance of the prescribing practitioner.
• Manufacturer. The manufacturer does not take any responsibility for any electrode placements other than recom-
mended.
• Pregnancy. The safety of electrical stimulation during pregnancy has not been established.
• Skin irritation. Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation
or electrical conductive medium (gel). The irritation may be reduced by using an alternate conductive medium or
alternate electrode placement. Some patients may experience redness under the electrodes after a session. This
redness usually disappears within a few hours. Advise the patient to consult 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 precautions recommended by
their physicians.
• Epilepsy. Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physi-
cians.
• Internal Bleeding. Use caution when the patient has a tendency to bleed internally, such as following an injury
or fracture.
• After Surgery. Use caution following recent surgical procedures when stimulation may disrupt the patient’s heal-
ing process.
• Over uterus. Do not place electrodes directly over the uterus or connect pairs of electrodes across the abdomen if
you are pregnant. The reason is that, theoretically, the current could affect the foetus’s heart (although there are
no reports of it being harmful).
• Lack of sensation. Use caution if stimulation is applied over areas of skin that lack normal sensation. Don’t apply
stimulation on patient unable to express themselves.
• Stimulation. The stimulator should only be used with skin electrodes intended for nerve and muscle stimulation.
Muscle soreness may occur after stimulation but usually disappears within a week.
• Hot casing or batteries. Under extreme use conditions, some parts of the casing might reach up to 109 °F (43
°C). Use caution when manipulating the batteries right after device use or when holding the device. There is no
particular health risk associated with this temperature besides your comfort.
• Children. Keep this device out of the reach of children.
• Electrode Size. Do not use electrodes with an active area less than 16 cm2, as there will be a risk of suffering a burn
injury. Caution should always be exercised with current densities more than 2mA/cm2.
• Strangulation. Do not wrap leadwires around your neck, and keep them out of the reach of children. Strangulation
may result from entanglement in the leadwires.
• Tripping. Care should be used to avoid tripping on lead wires.
• Damaged Device or Accessories. Never use the device or any of its accessories if it is damaged (case, cables, etc.)
or if the battery compartment is open as there is a risk of electric shock. Carefully inspect the lead wires and con-
nectors prior to each use.
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