Warnings / Precautionary Measures - ProMed EMT-6 Instruction Leaflet

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WARNINGS / RECAUTIONARY MEASURES
Precautionary measures / Negative reactions
Precautions
• TENS is not a substitute for pain medications and other pain
management therapies.
• TENS devices have no curative value.
• TENS is a symptomatic treatment and, as such, suppresses the
sensation of pain that would otherwise serve as a protective
mechanism.
• The success of the therapy depends to a considerable extent on
the patient's choice of physician and whether they are qualified
for the treatment of patients suffering from pain.
• The long-term effects of electrical stimulation are unknown.
• You may experience skin irritation or hypersensitivity due to
the electrical stimulation or electrical conductive medium.
• Use caution if you have a tendency to bleed internally, such
as following an injury or fracture.
• Consult with your physician prior to using the device after a
recent surgical procedure, because stimulation may disrupt
the healing process.
• Use caution if stimulation is applied over the menstruating or
pregnant uterus.
• Use caution if stimulation is applied over areas of skin that
lack normal sensation.
• Use this device only with the leads, electrodes, and accessories
recommended by the manufacturer.
• Do not modify the device or the electrodes without
authorization of the manufacture. This could cause improper
functioning.
• Because the effects of stimulation on the brain are unknown,
do not use the device on opposite sides or your head.
• This device is designed for use by and on a single adult
person.
• For hygienic reasons electrodes should not be shared.
• Do not modify electrodes(e.g. by cutting them). This increases
the current density, which is potentially hazardous and
effective current density beyond 2mA/cm2 requires increased
awareness.
Negative Reactions
• Long-term use can occasionally lead to skin irritation in the
area where the electrodes were placed.
• The effectiveness of the treatment depends greatly upon the
patient being treated by someone who is qualified in dealing
with patients suffering from pain.
• Potential negative reactions include skin irritation and burns
caused by the electrodes.
• You may experience skin irritation and burns beneath the
stimulation electrodes applied to your skin.
• You may experience headache and other painful sensations
during or following the application of electrical stimulation
near your eyes and to your head and face.
• You should stop using the device and should consult with
your physician if you experience adverse reactions from the
device.
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