User's Manual

Diathermy – High energy heat: used to cut or cauterize during surgery, or a type of therapy.
Electromagnetic Interference (EMI) – Electrical signals that interfere with the device function.
MRI (Magnetic Resonance Imaging) – Medical imaging: produces electronic images of tissues and
organs.
Paresthesia – Tingling sensation felt during therapy delivery: produced by spinal cord stimulation.
Precaution – Situations of which the patient should be aware in order to avoid uncomfortable stimu-
lation and possible damage to the TNS device.
Program – Instructions or changes to stimulation settings that are programmed into the Programmer
and transmitted to the TNS device.
Spinal Cord Stimulation – Electrical pulses applied to the spinal cord to block pain signals to the
brain.
Stimulation – A pain therapy reference to small electrical pulses felt as a tingling sensation that
replaces pain signals.
Stimulation Level – Measure of stimulation: can be increased or decreased within a range specified
by the clinician.
Warning – Potentially serious hazard to be aware of to avoid situations that could cause injury or
death.
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Introduction
This manual describes the care and use of the Trial Neurostimulator (MN0100).
IndicationsForUse
The Spinal Modulation Trial Neurostimulator System is intended as an aid in the management of
chronic pain.
Contraindications
Patients contraindicated for the Spinal Modulation Trial Neurostimulator System are those who:
Have an active implantable medical device including but not limited to
cardiac pacemakers and cardiac defibrillators
Are unable to operate the system
Are poor surgical risks
Are pregnant
Are under the age of 18
Description
The Trial Neurostimulator (TNS) attaches to the Connector Cable and delivers energy to the trial
leads. The TNS has a female locking connector that attaches to the Connector Cable, a standby
button that disables stimulation and a clip for the patient to attach the TNS to their belt or waist-
band.
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