User Manual

AXONICS SNM SYSTEM® – Neurosmulator | Rechargeable, Model 5101
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Table of Contents
LABEL SYMBOLS .................................................................................................................................................. 2
TABLE OF CONTENTS ......................................................................................................................................... 4
INTRODUCTION ................................................................................................................................................... 5
INDICATIONS, WARNINGS, AND PRECAUTIONS ........................................................................................... 5
DEVICE DESCRIPTION ........................................................................................................................................ 5
Package Contents .................................................................................................................................................................. 5
System Registration Form and Patient Identification Card .......................................................................................... 5
STORAGE AND USAGE ENVIRONMENT ........................................................................................................... 6
Component Packaging ......................................................................................................................................................... 6
Sterilization .............................................................................................................................................................................. 6
SPECIFICATIONS .................................................................................................................................................. 7
XRAY IDENTIFICATION ....................................................................................................................................... 8
NEUROSTIMULATOR IMPLANT PROCEDURE ................................................................................................. 9
Procedure Supplies ............................................................................................................................................................... 9
Neurostimulator Preparation ............................................................................................................................................... 9
Creating the Neurostimulator Pocket ............................................................................................................................... 9
Connecting the Lead to the Neurostimulator ................................................................................................................ 10
Implanting the Neurostimulator ..........................................................................................................................................11
Completing the Implant Procedure ..................................................................................................................................12
Post-Surgery Management ................................................................................................................................................. 12
Replacing the Neurostimulator .......................................................................................................................................... 12
WIRELESS COMMUNICATION ........................................................................................................................... 13
CUSTOMER SERVICE .......................................................................................................................................... 13