User's Manual

Precision Spectra™ System Information for Patients
90668560-01 Rev B 1 of 32
Table of Contents
Safety Information .................................................................................................2
Indications for Use ........................................................................................................................2
Precision Spectra System Clinical Summary ................................................................................2
Table 1: Summary of Risks Identifi ed in the Retrospective Clinical Studies ..............................7
Table 2: Clinical Experience Safety ...........................................................................................8
Contraindications ........................................................................................................................10
Warnings .....................................................................................................................................10
Precautions .................................................................................................................................13
Adverse Effects ...........................................................................................................................17
FCC Rules ...................................................................................................................................19
Patient Identifi cation Card ...........................................................................................................20
End of Programmed Service .......................................................................................................20
IPG Battery Life............................................................................................................................21
Contacting Boston Scientifi c .............................................................................22
Glossary ...............................................................................................................23