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 stimula-
tion 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.
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 compo-
nents 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