User's Manual

Table Of Contents
Table of Contents
Additional Technical Information..................................................................................................... 1
Device Description.......................................................................................................................... 1
Related Information ........................................................................................................................ 3
Intended Audience ................................................................................................................4
Indications and Usage.................................................................................................................... 4
Contraindications............................................................................................................................ 4
Warnings ........................................................................................................................................ 5
Precautions..................................................................................................................................... 7
Supplemental Precautionary Information ..................................................................................... 18
Post-Therapy Pulse Generator Follow Up .......................................................................... 18
Transcutaneous Electrical Nerve Stimulation (TENS)......................................................... 19
Electrocautery and Radio Frequency (RF) Ablation............................................................ 21
Ionizing Radiation................................................................................................................ 22
Elevated Pressures ............................................................................................................. 23
Potential Adverse Events ............................................................................................................. 24
Mechanical Specications ............................................................................................................ 27
Items Included in Package ........................................................................................................... 30
Symbols on Packaging................................................................................................................. 31
Characteristics as Shipped........................................................................................................... 35
X-Ray Identier............................................................................................................................. 37
Federal Communications Commission (FCC) . ............................................................................. 38
Pulse Generator Longevity........................................................................................................... 38
Warranty Information .................................................................................................................... 43
Product Reliability.............................................. ........................................................................... 43
Patient Counseling Information ....................................................................................................44
Patient Handbook................................................................................................................ 45
Lead Connections......................................................................................................................... 45