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 stimulation 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).
IndicationsForUse
The Spinal Modulation Trial Neurostimulator System is intended as an aid in the management of chronic,
intractable, neuropathic pain of the lower limbs-including unilateral or bilateral pain, associated with the
following conditions: radicular pain, peripheral neuropathies.
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 waistband.
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