User manual

SENSUS
Pain Management User Manual
38
APPENDIX F: Prescribing Information
UNITED STATES FEDERAL LAW RESTRICTS THIS DEVICE
TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR
LICENSED MEDICAL PROFESSIONAL.
Indications
The NeuroMetrix SENSUS is intended for use as a transcutaneous
electrical nerve stimulator for the symptomatic relief and
management of chronic intractable pain.
Contraindications
Do not use this device on patients who have a cardiac
pacemaker, implanted debrillator, or other implanted metallic
or electronic device, because this may cause electric shock,
burns, electrical interference, or death.
The device should not be used on patients whose pain
syndromes are undiagnosed.
Precautions
Transcutaneous electrical nerve stimulation is not effective
for pain of central origin, including headache.
Transcutaneous electrical nerve stimulation is not a substitute
for pain medications and other pain management therapies.
Transcutaneous electrical nerve stimulation devices have
no curative value.
Transcutaneous electrical nerve stimulation is a symptomatic
treatment and, as such, suppresses the sensation of pain that
would otherwise serve as a protective mechanism.
Effectiveness is highly dependent upon patient selection by
a licensed medical professional qualied in the management
of pain patients.