Select User’s Manual
11
Prescribing InformationPrescribing Information
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 to 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 the prescribing
physician or licensed practitioner.
Lead connection
– Do not connect the lead wires to an AC power source or other
equipment not specified as safe for the lead wires. Doing so could result in severe shock
or burns whether or not the lead wires are attached to the stimulator.
Electromagnetic compatibility
– Care must be taken when operating this device
adjacent to or stacked with 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 it. (i.e. cell phones, etc.)
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 or cables may result in increased emissions or decreased immunity of
this device.
Defibrillation signals
– Remove the TENS electrodes 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 sites during the defibrillation.
Safety
– The safety and efficacy of the Select system depends on the proper use and
handling of the device and accessories. If used improperly, the Select system has a
potentially hazardous electrical output. It must be used only as prescribed. Electrode
or lead wire burns may result from misuse. Electrodes and lead wires should be securely
fastened to prevent inadvertent disconnection. The length of lead wires could result in
injury. Electrodes and lead wires 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. Improper
application may result in patient injury. If any question arises as to the proper electrode
size, consult a licensed practitioner prior to therapy session.
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.
Uterus
– Do not use electrical stimulation over a menstruating or pregnant uterus.
Sensory loss
– Do not use electrical stimulation where sensory nerve damage is present,
causing a loss of normal skin sensation.
Unequal electrode size
– Using different size electrodes together can cause skin irritation
or increased stimulation intensity under the smaller electrode. Some programs may require
the use of different sized electrodes for treatment.
Prescription
– Use electrical stimulation only in the prescribed manner and for the
prescribed diagnosis. If there are any changes in an existing condition, or if a new condition
develops, the patient should consult a physician.
Effectiveness
– Effectiveness is highly dependent upon patient selection by a clinician
qualified in the management of pain or rehabilitation.
Keep out of reach of children
– Keep this device out of the reach of children. If the
patient is a child, make sure he/she is properly supervised during electrical stimulation.
Leads and electrodes
– Use the device with only the leads and electrodes provided for
use by
the manufacturer. The safety of other products has not been established, and their
use could result in injury to the patient. Use only the electrode placements and stimulation
settings prescribed by your practitioner.
NOTE:
An electrode active area of no less than 1.227 in
2
(7.917 cm
2
) is recommended for
the Select system.
NOTE:
The Select system requires the use of Empi lead wires with the custom safety
connection as pictured.
Precautions
user_manual_NEW_BH_edit_r5.indd 10-11 3/3/08 2:08:33 PM
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