Boston Scientific Precision - Device and Product Description; Implantable Pulse Generator; Leads

Precision™ Spinal Cord Stimulator System Clinician Manual
Clinician Manual
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Device and Product Description
The Precision system consists of an implantable pulse generator, temporary and permanent percutaneous
leads, surgical paddle leads, and lead extensions, each packaged as a separate kit. Single use accessories
and disposable tools are also included in these kits.
Features of the Precision SCS System include:
• Stimulation electrode eld navigation
• Sixteen independent current-controlled electrodes
• Four programmable stimulation areas per program; four possible
programs
• Long-life operation
• High-range parameter capability
• Small size
• Two-foot programming range
• This product contains no detectable latex
Implantable Pulse Generator
The Precision Implantable Pulse Generator (IPG) system is intended to treat chronic pain by electrically
stimulating the spinal cord. The multi-channel, multi-electrode device capability provides exibility in
conjunction with ease of programming. A rechargeable battery increases IPG longevity and output capability
while reducing size and device replacement surgeries. The IPG is controlled by a handheld Remote Control,
and can be engaged by a clinician computer using proprietary Bionic Navigator software. Periodically, the
IPG battery requires replenishing with an RF charging device provided separately in the Patient Charging Kit.
Leads
The percutaneous and surgical paddle leads function as a component of the Precision SCS system by
delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an
inhibition of pain sensation.
Surgical Paddle Lead
The 2x8 Surgical Paddle Lead is available in lengths of 50 cm and 70 cm. The distal (paddle) end of the
lead has two columns of eight evenly spaced planar electrodes. Each electrode is 3x2 mm
2
in area. On the
proximal side, this lead employs 2 lead tails. The end of each tail has eight evenly spaced contacts, identical
to the percutaneous leads. The right tail of the Paddle Lead is laser-etched to allow for ease of right and left
identication. Each tail can be inserted into an IPG or into a lead extension.
Percutaneous Leads
The eight-contact percutaneous leads are available in lengths of 30 cm, 50 cm, and 70 cm. Each lead has
eight electrode contacts located near the distal end. Each contact is 3 mm in length and is spaced 1, 4, or
6 mm from the adjacent contact. The 16 contact percutaneous lead (Innion™ 16 Lead and Innion CX
Lead) is available in lengths of 50 cm and 70 cm. Each lead has 16 contacts located near the distal end.
Each contact is 3 mm in length and is spaced 1 mm from the adjacent contact. The Innion 16 lead must be
inserted into a Splitter 2x8 which then connects to a Precision IPG’s 8 contact ports or 8 contact OR Cables.