Prescribing Information - Ultima 20 User Manual

User Manual for Ultima 20 T.E.N.S UNIT
PRESCRIBING INFORMATION
FOREWORD
Read this manual carefully before using your Ultima
20 T.E.N.S. unit.
The manufacturer strongly recommends carefully
reading the "Warnings and Cautions", and subsequent
chapters of this manual.
WARNINGS AND CAUTIONS
Prescription labeling:
Federal law restricts this device to sale or use by or on
the order of a practitioner so licensed by the state.
Contraindications:
1 . Do not place the pads on the carotid sinuses located at
the two sides of the neck, (where a doctor feels for a
pulse), or over the eyes.
2. Do not use this T.E.N.S. unit if you have a heart
pacemaker or serious heart rhythm problem.
3. Any electrode placement that causes current to flow
transcerbrally (through the head).
4. The use of T.E.N.S. whenever pain syndromes are
undiagnosed, until etiology is established.
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WARNINGS
1. Do not use this T.E.N.S. unit during the
pregnancy or at anytime on the abdomen during
pregnancy.
2. This T.E.N.S. unit is not effective for pain of
central origin, including headache.
3. T.E.N.S. unit should be used only under the
continued supervision of a physician.
4. T.E.N.S. unit has no curative value.
5. T.E.N.S. is a symptomatic treatment and as such
suppresses the sensation of pain, which would
otherwise serve as a protective mechanism.
6. The user must keep the device out of the reach
of children.
7. Electronic monitoring equipment may not
operate properly when T.E.N.S. stimulation is in
use.
8. Do not use T.E.N.S. unit if you are driving or
operating machinery.
9. If you have epilepsy, consult your doctor.
PRECAUTIONS
1. Isolated cases of skin irritation may occur at the
site of electrode placement following long-term
application.
2. Effectiveness is highly dependent upon patient
selection by a person qualified in the
management of pain patients.
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