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5
Indications, Contraindications & Adverse Effects
General information
:
This TENS is a lightweight and portable medical device which can help to reduce pain and discomfort. It
utilizes low electric-current to stimulate nerves to achieve the symptomatic relief of chronic-intractable, post-
traumatic and post-surgical pain.
Cautions
:
Federal law (USA) restricts this device to sale by or on the order of practitioners licensed by the State in which
they practice to use or order the use of the device.
Indications of use
:
This device is used for symptomatic relief of chronic-intractable, post-traumatic and post-surgical pain.
Contraindications:
Do not use this device on patients who have a cardiac pacemaker, implanted defibrillator, or other
implanted metallic or electronic device, because this may cause electric shock, burns, electrical
interference, or death.
Do not use this device on patients whose pain syndromes are undiagnosed.
Warnings
Do not apply stimulation over the patient’s neck because this could cause severe muscle spasms
resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood
pressure;
Stimulation should not be applied over the carotid sinus nerves (anterior neck), particularly in
patients with a known sensitivity to the carotid sinus reflex or transcereberally (through the head).
Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and
pharyngeal muscles may occur and the contractions may be strong enough to close the airway or
cause difficulty in breathing.
Do not apply stimulation over head, or in proximity to eyes;
Do not apply stimulation across th
e patient’s chest, because the introduction of electrical current into
the chest may cause rhythm disturbances to the patient’s heart, which could be lethal; Consult your
physician before using this device, because the device may cause lethal rhythm disturbances to the
heart in susceptible individuals;
Do not apply stimulation over open wounds, rashes, swollen, red, infected, inflamed or eruptions of
the skin (e.g., phlebitis, thrombophlebitis, varicose veins);
Do not apply stimulation over, or in proximity to, cancerous lesions;
Do not apply stimulation 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;
Do not apply stimulation when the patient is in the bath or shower;
Do not apply stimulation while the patient is sleeping;
Do not apply stimulation while the patient is driving, operating machinery, or during any activity in
which electrical stimulation can put the patient at risk of injury.
Apply stimulation only to normal, intact, clean, healthy skin.
Precautions:
Effectiveness of TENS devices is highly dependent upon patient selection by a practitioner qualified
in the management of pain patients;
The long-term effects of electrical stimulation are unknown;
