EMPI Active
User Guide
4
EMPI Active
User Guide
Prescribing Information
continued
Warnings
Supervised use:
This device should only be operated under the prescription and
supervision of a physician (or licensed practitioner) who is familiar with the precau-
tionary 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) because 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 erup-
tions, 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 electrode or 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 healthcare
professional if this does not resolve the problem or if the problem persists.
Prescribing Information
continued
Skin reactions:
On rare occasions, therapy can result in transient skin reactions
such as rash, inflammation, irritation, or burns. These skin reactions may be the result
of individual sensitivity or the condition of the skin at the onset of treatment, reaction
to the materials in the electrodes, or a poor connection between the electrode and
your skin. If a visible skin reaction does occur, discontinue the treatment and consult
your healthcare professional.
Electromagnetic compatibility:
Care must be taken when operating this device
adjacent to other equipment. Potential electromagnetic or other interference could
occur to this or other equipment. Try to minimize this interference by not using other
equipment in conjunction with this device (i.e. cell phones, etc.).
Lead connection:
Do not connect the lead wires or specialized wrap to an AC
power source or other equipment not specified as safe for the lead wire or special-
ized wrap. Doing so could result in severe shock or burns whether or not the lead
wires or specialized wrap is attached to the stimulator.
Accessories:
Use only accessories that are specially designed for this device. Do
not use accessories manufactured by other companies on this device. Empi is not
responsible for any consequence resulting from using products manufactured by
other companies. The use of other accessories may result in increased emissions or
decreased immunity of this device.
Defibrillation signals:
Remove the TENS electrode before defibrillation signals are
applied. Defibrillation of a person wearing a TENS device can damage the device
whether it is turned on or off. Under some circumstances there can be risk of burns
under the electrode site during the defibrillation.
Safety:
The safety and efficacy of the Empi Active system depend on the proper use
and handling of the device and accessories. If used improperly, the Empi Active
system has a potentially hazardous electrical output. It must be used only as
prescribed. Electrode burns may result from misuse. Electrodes should be securely
fastened to prevent inadvertent disconnection. Electrodes will eventually wear out.
Check accessories regularly for signs of wear, and replace if needed.
Proper electrode size:
Output current density is related to electrode size or
conductive zones. Improper application may result in patient injury. If any question
arises as to the proper electrode size, consult a healthcare professional prior to
therapy session.
Precautions
Epilepsy:
Use caution for patients with suspected or diagnosed epilepsy when
using this device.
Hemorrhages:
Use caution when there is a tendency to hemorrhage, such as
following acute trauma or fracture.
Post-surgical use:
Use caution following recent surgical procedures when muscle
contraction may disrupt the healing process.
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