AXONICS SNM SYSTEM® – Neurostimulator | Recharge-Free, Model 4101 Page 4
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 .......................................... 14