Tabla De Contenido - St. Jude Medical GII Proclaim Manual De Instrucciones

EN: English
Implantable Pulse Generator
Proclaim™ IPG
Clinician's Manual
Contents
Prescription and Safety Information ........................................................................... 2
Intended Use .................................................................................................................... 2
Indications for Use ............................................................................................................ 2
Contraindications ............................................................................................................... 2
MRI Safety Information ...................................................................................................... 2
Warnings .......................................................................................................................... 2
Precautions ....................................................................................................................... 3
Adverse Effects.................................................................................................................. 5
Product Description ................................................................................................... 5
Package Contents .............................................................................................................. 5
Identifying the IPG ............................................................................................................. 6
Directions for Use...................................................................................................... 6
Creating an IPG Pocket ...................................................................................................... 6
Connecting a Lead or Extension to the IPG .......................................................................... 7
Implanting the IPG ............................................................................................................ 8
Replacing the IPG ............................................................................................................. 9
Disposing of Explanted Components ................................................................................. 10
Checking the Status of the IPG Battery ..................................................................... 10
Technical Support ................................................................................................... 10
Appendix A: Product Specifications ......................................................................... 10
Storage Specifications ...................................................................................................... 10
Product Materials ............................................................................................................ 11
IPG Specifications ........................................................................................................... 11
Compatibility Guidelines for IPGs with Compatible Headers................................................ 12
Appendix B: System Components and Accessories .................................................. 12
IPGs ............................................................................................................................... 13
Programmers and Controllers ........................................................................................... 13
Leads and Extensions ...................................................................................................... 13
Trial System .................................................................................................................... 14
Appendix C: Regulatory Statements ......................................................................... 14
Disposal Guidelines for Battery-Powered Devices .............................................................. 14
Statement of FCC Compliance .......................................................................................... 14
Statement of Compliance With License-Exempt RSS Standard (Canada) ............................. 15
Identification Information for Product Registration ............................................................. 15
Wireless Technology Information ...................................................................................... 15
Radio Transmitter, Cables, Transducers ........................................................................... 15
Quality of Service for Wireless Technology ......................................................................... 16
Appendix D: Symbols and Definitions....................................................................... 17
Additional Symbols for Product Labels .............................................................................. 18
Appendix E: CE Mark Date ...................................................................................... 18
ARTMT100140147B.pdf 5
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