Boston Scientific Neuromodulation Corporation SC1132 사용자 설명서
Table of Contents
Implantable Pulse Generator
90655621-03 Rev A iii of iv
Product Model Number
SC-1132 Implantable Pulse Generator
Refer to the Indications for Use for indications and related information.
Refer to the appropriate Information for Prescribers manual for contraindications, warnings,
precautions, adverse events summary, Physician instructions, sterilization, component disposal,
and contact information for Boston Scientifi c. Refer to the Labeling Symbols Addendum for an
explanation of labeling symbols.
precautions, adverse events summary, Physician instructions, sterilization, component disposal,
and contact information for Boston Scientifi c. Refer to the Labeling Symbols Addendum for an
explanation of labeling symbols.
Refer to the following Directions for Use (DFU) for device specifi c instructions not included
in this manual: Surgical Leads DFU, Percutaneous Leads DFU, Precision Spectra™ System
Clinician Remote Control DFU, Clinician Trial Manual, Precision Spectra System Programming
Manual, and Programming Wand DFU.
Refer to the Limited Warranty for warranty information.
in this manual: Surgical Leads DFU, Percutaneous Leads DFU, Precision Spectra™ System
Clinician Remote Control DFU, Clinician Trial Manual, Precision Spectra System Programming
Manual, and Programming Wand DFU.
Refer to the Limited Warranty for warranty information.
For information regarding the Patient Identifi cation Card, FCC rules and for clinical
studies supporting the clinical use of the neurostimulation system, refer to the Information for
Prescribers manual.
Prescribers manual.
Table of Contents
Description ......................................................................................................................1
Package Contents ..........................................................................................................1
IPG Kit ......................................................................................................................... 1
Specifi cations and Technical Data ................................................................................3
Registration Information ................................................................................................3
Instructions for Use ........................................................................................................4
IPG Handling and Storage .......................................................................................... 4
Pre-Op Instructions ..................................................................................................... 4
IPG Implantation ......................................................................................................... 4
Tunneling the Lead or Lead Extension ....................................................................... 5
IPG Explant or Replacement....................................................................................... 9
Pre-Op Instructions ..................................................................................................... 4
IPG Implantation ......................................................................................................... 4
Tunneling the Lead or Lead Extension ....................................................................... 5
IPG Explant or Replacement....................................................................................... 9
Rechargeable Stimulator System .................................................................................9
Charging Steps .............................................................................................................10
WARNINGS: ............................................................................................................. 10
IPG Battery Status ........................................................................................................ 11