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Device and Product Description
Device and Product Description
The Spectra WaveWriter Spinal Cord Stimulator (SCS) System consists of an Implantable
Pulse Generator (IPG), temporary and permanent Percutaneous Leads, Surgical Paddle Leads,
Lead Extensions, OR Cables, Trial Stimulator, Remote Control, Clinician Programmer, and
Programming Wand, each packaged as a separate kit. Single use accessories and disposable
tools are also included in these kits.
Features of the Spectra WaveWriter SCS System include:
• Automatic program cycling
• MicroBurst capability between 0 to 1 second range
• Programming of multi-areas at rates greater than 130 Hz
• Patient-provided Therapy Rating Stimulation electrode field navigation
• Thirty-two independent current-controlled electrodes
• Four programmable stimulation areas per program; sixteen possible programs
• Long-life operation
• High-range parameter capability
• Small size
• Two-foot programming range
• This product contains no detectable latex
Contraindications
Patients contraindicated for permanent Spinal Cord Stimulator (SCS) therapy are those who:
• are unable to operate the SCS system
• have failed trial stimulation by failing to receive effective pain relief
• are poor surgical risks
• are pregnant
Safety Information
WARNING: Unauthorized modification to the medical devices is prohibited. System integrity
could be compromised and harm or injury to the patient could occur if the medical devices are
subjected to unauthorized modification.
Instructions for the Patient
Warnings
Heat Due to Charging. Patients should not charge while sleeping. This may result in a burn.
While charging, the Charger may become warm. It should be handled with care. Failure to
use the Charger with either the Charging Belt or an adhesive patch, as shown, may result
Spectra Wavewriter™ System Information for Prescribers
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