Empi EPIX VT - Page 9

User Information
Warnings continued
¢ Patient Monitoring Equipment - TENS devices may interfere
with the intended operation of electronic monitoring
equipment (such as ECG monitors or ECG alarms) if the
stimulator is simultaneously connected to the patient being
monitored.
Safety and Efficacy - The safety and efficacy of TENS depends
on the proper use and handling of the device and accessories.
IF USED IMPROPERLY, TENS 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.
Electrodes and lead wires will eventually wear out. Check
accessories regularly for signs of wear, and replace if needed.
/\ Precautions
Review the following precautions:
¢ Prescribed Conditions - TENS therapy should not be used for
conditions other than those for which the device is prescribed.
lf there are any changes in an existing condition, or if a new
condition develops, the patient should consult a clinician.
¢ Patient Selection - The efficacy of TENS therapy is highly
dependent upon patient selection by a person qualified in the
management and treatment of pain.
¢ Drugs or Mental State - Treatment outcome will be influenced
by the patient’s psychological state and use of drugs.
¢ Sensitivity to Stimulation - Patients who react negatively to
the stimulation sensation after an adequate trial period or who
find stimulation intolerable should not undergo further TENS
treatment.
¢ Sensory Deprivation - Due to the risk of adverse skin
reactions, electrodes should not be placed on areas of skin
with reduced response to normal sensory stimuli.
Skin Irritation - Skin irritation, hypersensitivity and burns
beneath electrodes have been reported with the use of TENS.
Electrodes should not be left in place for long periods of time
without checking or cleaning the skin underneath them.
Electrode sites should be rotated with long term use when
possible. DO NOT CONTINUE STIMULATION OVER
IRRITATED SKIN. Consult a clinician if any skin irritation or
reaction develops at the electrode sites following use of the
stimulator. The clinician may recommend a different type of
electrode.
Operating Machinery - Do not operate hazardous equipment
such as automobiles or power tools while using TENS. Abrupt
changes in sensation can occur during the use of TENS which
could startle the patient and create a hazard.
Cellular (Wireless) Telephones and Two Way Radios - Avoid
operation in close proximity (e.g. < 1m) to transmitting
cellular (wireless) telephones or two-way radios. This
equipment may produce instability in the stimulator output.
Sudden, unexpected changes in output could startle the
patient and create a hazard.