Empi Select - Prescribing Information and Safety

Select User’s Manual
8
Select User’s Manual
9
Prescribing InformationPrescribing Information
In general, stimulation should be used under medical supervision in the management of
specific conditions.
Read, understand, and practice the precautionary and operating instructions found in this
manual. Know the limitations and hazards associated with the Select Pain Control system.
Observe any and all precautionary and operational decals placed on the unit.
Indications
TENS devices are indicated for:
• Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain
• For the relief of pain associated with arthritis
Contraindications
TENS treatments should not be used if you have any of the following:
Cardiac pacemakers – Do not use this device if the patient has a demand-type
cardiac pacemaker or any implanted defibrillator.
Transcerebral stimulation – Do not apply electrical stimulation transcerebrally
(through the head).
Carotid sinus – Do not use electrical stimulation over the carotid sinus nerves (throat).
Unknown etiology – Do not use this device when pain syndromes are undiagnosed.
Use only after origin of pain has been diagnosed.
Warnings
Supervised use – This device should only be operated under the prescription and
supervision of a physician (or licensed practitioner) that is familiar with the precautionary
measures and operational functions associated with the unit being used.
Long-term effects – The long-term effects of chronic use of electrical stimulation are
unknown. Electrical stimulation devices do not have any curative value.
Symptomatic treatment – This device is a symptomatic treatment and, as such,
suppresses the sensation of pain, which would otherwise serve as a protective mechanism.
Central origin pain – Electrical stimulation is not effective for central origin pain such
as headache.
Pregnancy – The safety of using electrical stimulation during pregnancy or birth has not
been established.
Throat stimulation – Severe spasm of the laryngeal and pharyngeal muscles may occur
when the
electrodes are placed across the throat or mouth. This may be strong enough to
close off the airway or cause breathing difficulty.
Transthoracic stimulation – Do not apply electrical stimulation transthoracically
(through the chest area) in that the introduction of electrical current into the heart may
cause cardiac arrhythmias.
Skin and vascular problems – Do not use this device over infected areas, skin eruptions,
or areas of decreased sensation.
Heart disease – Precaution should be taken prior to using electrical stimulation on
patients suspected of having heart disease.
High frequency surgical devices – Simultaneous connection of a patient to a high
frequency surgical device may result in burns at the site of the electrodes and possible
damage to the device.
Damage from liquids – Do not immerse the device in water or other liquids. Water or
liquids could cause malfunction of internal components of the system, causing a risk of
injury to the patient.
Electrical shock – To prevent electrical shock, disconnect the unit from the power source
before attempting any maintenance procedures.
Uncomfortable stimulation – If the stimulation levels are uncomfortable or become
uncomfortable, reduce the intensity to a comfortable level. Contact your clinician if this
does not resolve the problem or if the problem persists.
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