Abbott Proclaim 3667 - Default Chapter; Table of Contents

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Contents
Prescription and Safety Information ........................................................................... 1
Intended Use ....................................................................................................................... 1
Indications for Use ............................................................................................................... 1
Contraindications ................................................................................................................. 1
MRI Safety Information ......................................................................................................... 1
Warnings ............................................................................................................................. 1
Precautions .......................................................................................................................... 3
Adverse Effects .................................................................................................................... 6
System Overview ....................................................................................................... 6
Product Description ................................................................................................... 7
Package Contents ................................................................................................................ 8
Identifying the IPG ............................................................................................................... 8
Directions for Use ...................................................................................................... 8
Creating an IPG Pocket ........................................................................................................ 8
Connecting a Lead or Extension to the IPG ........................................................................... 9
Implanting the IPG ............................................................................................................. 11
Replacing the IPG .............................................................................................................. 12
Disposing of Explanted Components ................................................................................... 12
Checking the Status of the IPG Battery ..................................................................... 12
Technical Support ................................................................................................... 13
Appendix A: Product Specifications ......................................................................... 13
Storage Specifications ........................................................................................................ 13
Product Materials ............................................................................................................... 13
IPG Specifications .............................................................................................................. 14
Compatibility Guidelines for IPGs with Compatible Headers................................................. 15
Appendix B: System Components and Accessories .................................................. 16
IPGs .................................................................................................................................. 16
Programmers and Controllers ............................................................................................. 16
Leads and Extensions ......................................................................................................... 16
Adapters ............................................................................................................................ 17
Trial System ....................................................................................................................... 17
Appendix C: Battery Longevity Information ............................................................... 18
Energy Factors for Tonic Stimulation Parameters ................................................................ 19
Energy Factors for BurstDR™ Stimulation Parameters ........................................................ 23
Battery Longevity Graphs .................................................................................................... 25
Appendix D: Regulatory Statements ......................................................................... 26
Disposal Guidelines for Battery-Powered Devices ................................................................ 26
Statement of FCC Compliance ............................................................................................ 26
Statement of Compliance With License-Exempt RSS Standard (Canada) ............................. 26
Identification Information for Product Registration ............................................................... 26
Wireless Technology Information ........................................................................................ 27
Radio Transmitter, Cables, Transducers ............................................................................. 27
Quality of Service for Wireless Technology .......................................................................... 28