User's Manual
The output ranges for the system are:
FREQUENCY BAND: The TNS device uses the one frequency band designated specifically for implanted
medical devices; the Medical Implant Communications Service (MICS) to communicate with the Programmers.
The MICS band operates from 402 MHz to 405 MHz. The Listen Before Talk (LBT) protocol allows multiple
pieces of equipment in the location to communicate at the same time without interference.
The Clinical and Patient Programmers are used to communicate with the Trial Neurostimulator.
The Clinical Programmer is used to program the stimulation parameters in the TNS, as determined by
the physician. The TNS device delivers the programmed stimulation parameters (energy) to the
Leads.
The Patient Programmer is easy to use and allows the patient to adjust the stimulation level within limits
preset by the physician. It allows the patient to turn stimulation off.
The Clinical and Patient Programmers are portable, hand-held devices powered by internal batteries. The
batteries are rechargeable using Programmer Charger MN3400 (provided) and a power outlet. Both Program-
mers contain an internal magnet used to connect to the TNS device.
Parameter Range
Frequency (Hz) 4 – 100
Pulse Width (µs) 40 – 720
Amplitude (µA)
50 – 6000
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Both Programmers come with a carrying case and should be kept dry. Images depicting the components of
the Spinal Modulation TNS System are shown in Figure 1.
• The patient must be trained by their doctor before using the Patient Programmer and the NS device.
• The patient must not use their Patient Programmer until their doctor has set up the NS System.
• The patient must not undergo any elective magnetic resonance imaging (MRI). If MRI is necessary, the
doctor should remove any lead(s) and disconnect the NS device. Use of MRI near the lead(s) may
dislodge the lead(s) or damage the NS device. If a voltage is induced through the lead, it may cause
uncomfortable (“jolting” or “shocking”) levels of stimulation.
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Figure 1: The Trial Neurostimulator System
WARNINGS
TNS
Programmer
Connector
Cable
Lead