Programming Manual

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should be less than the compliance
level in each frequency range (Note B).
Interference may occur in the vicinity of
equipment marked with the following
symbol.
Note 1: At 80 MHz and 800 MHz. The higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
Note A: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) and land mobile radios, amateur
radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Pulsante® SPG Microstimulator System is used exceeds the applicable RF compliance level above, the
Pulsante® SPG Microstimulator System should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the Pulsante® SPG Microstimulator System.
Note B: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
The RC-300 of the Pulsante® SPG Microstimulator System is battery operated and the NS-100 is
battery less active device works in conjunction with RC.
NOTE: The Pulsante® SPG Microstimulator System should not be used while stacked on or adjacent
to other equipment. If stacked use is necessary, the equipment should be observed to verify normal
operation in the configuration in which it will be used. Portable and mobile RF communications
equipment can affect the System; the following separation distances are recommended.
Specifications for the Pulsante® Microstimulator:
STIMULATION PARAMETER
SPECIFICATION
Power Source
Resonate Inductive Coupling, no finite life
Channels
Six (6) Channels
Waveform Characteristics for Each Channel
Biphasic, constant current, charge balanced, rectangular pulse
Output Current
0-3.9 mA
0.05 mA steps (from 0.0-1.0 mA)
0.10 mA steps (from 1.0-3.9 mA), ± 20%
Signal Frequency
1-200 Hz
1 Hz steps (from 1-20 Hz), 5 Hz steps (from 20-40 Hz)
10 Hz steps (40-200 Hz), ± 20%
Pulse Width Per Phase
40-480 µsec
steps: 40, 47, 55, 63, 71, 79, 87, 95, 103, 110, 118, 126, 134, 142, 150, 158,
166, 174, 181, 189, 197, 213, 229, 244, 260, 276, 292, 308, 323, 339, 355,
371, 386, 402, 418, 434, 450, 465, 480 µs ± 20%
Electrode Configuration
2 to 6 electrodes as anode, cathode or OFF
Leakage Current (No Output)
1 µA
Net DC Current
500 nA
PHYSICAL CHARACTERISTICS
SPECIFICATION
Sizes
Short (~3.6 cm) Medium (~4.4 cm), Long (~5.2 cm), Extra-Long (~6.0 cm)
Body
16 x 8 x 4 (Length x Width x Height) mm ± 20%
Lead
1.0 mm ± 10% in Diameter
Fixation Plate Bone Screws
Accepts standard bone screws 1.8 mm in Diameter
Bone Fixation Plate
17.4 x 3.7 x 0.5 (Length x Width x Thickness) mm ± 20%
Weight
~1.49 grams (Short) – ~1.52 grams (Extra-Long)
Volume
~515 mm3 (Short) – ~590 mm3 (Extra-Long)
Storage Temperature
-10 0C (-14 0F) and +55 0C (+131 0F)
MATERIALS
SPECIFICATION
Microstimulator Body and Lead
Polyurethane-silicone co-polymer
(Material Contacts Human Tissue)
Electrodes
Platinum (90%) / Iridium (10%)
(Material Contacts Human Tissue)
Bone Fixation Plate
Titanium, Grade 2
(Material Contacts Human Tissue)