12
GB
• Across the head. Since the effects of stim-
ulation of the brain are unknown, stimula-
tion should not be applied across the head,
and electrodes should not be placed on
opposite sides of the head.
• Stimulation over compromised skin. Do not
apply stimulation over open wounds or
rashes, or over swollen, red, infected, or in-
flamed areas or skin eruptions (e.g., phlebi-
tis, thrombophlebitis, varicose veins).
• Stimulation near cancerous lesions. Do not
apply stimulation over, or in proximity to,
cancerous lesions.
• Stimulation over eyes. Do not apply stimu-
lation directly on the eyes.
• Environment. Electronic monitoring equip-
ment. Do not apply stimulation in the
presence of electronic monitoring equipment
(e.g., cardiac monitors, ECG alarms), which
may not operate properly when the elec-
trical stimulation device is in use.
• Bath or Shower. Do not apply stimulation
when the patient is in the bath or shower.
Do not apply stimulation in humid atmos-
phere exceeding 75% of relative humidity.
• Sleeping. Do not apply stimulation while
the patient is sleeping.
• Driving or operating machinery. Do not ap-
ply stimulation while the patient is driving,
operating machinery, or during any activity
in which electrical stimulation or involun-
tary muscle contraction can put the pa-
tient at risk of injury.
12.1. Contraindications
• Implanted electronic devices. Do not use
the device on patients who have a cardiac
pacemaker, implanted defibrillator, or other
implanted electronic device, because this
may cause electric shock, burns, electrical
interference, or death.
• TENS for Undiagnosed Pain. Do not use the
device as a TENS device on patients whose
pain syndromes are undiagnosed.
12.2. Warnings
• Consult with physician. Consult with the
patient’s physician before using the device,
because the device may cause lethal
rhythm disturbances to the heart in sus-
ceptible individuals.
• Skin condition. Apply stimulation only to
normal, intact, clean, healthy skin.
• Long term effects. The long-term effects of
chronic electrical stimulation are
unknown.
• Stimulation location. Stimulation over
Neck or Mouth. Do not apply stimulation
over the patient’s neck (especially the ca-
rotid sinus) or the patient’s mouth, because
this could cause severe muscle spasms re-
sulting in closure of the airway, difficulty in
breathing, or adverse effects on heart
rhythm or blood pressure.
• Stimulation across Chest. Do not apply
stimulation across the patient’s chest, be-
cause the introduction of electrical current
into the chest may cause rhythm disturbances
to the patient’s heart, which could be lethal.
12. PRECAUTIONARY MEASURES
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