Neuropace RNS System - Default Chapter; Table of Contents

Table of Contents 1
RNS
®
System User Manual
TABLE OF CONTENTS
INTRODUCTION ........................................................................................................................................... 5
CONTACTING NEUROPACE .......................................................................................................................... 5
ABOUT THIS MANUAL ................................................................................................................................... 5
RNS
®
SYSTEM ............................................................................................................................................. 8
INDICATIONS ............................................................................................................................................... 8
CONTRAINDICATIONS ................................................................................................................................... 8
WARNINGS AND PRECAUTIONS .................................................................................................................... 8
IMPLANTED RNS
®
SYSTEM ........................................................................................................................ 18
RNS
®
SYSTEM DESCRIPTION .................................................................................................................... 18
RNS
®
NEUROSTIMULATOR ........................................................................................................................ 21
RNS
®
SYSTEM COMPONENTS AND ACCESSORIES ...................................................................................... 21
NEUROPACE
®
CORTICAL STRIP LEAD ........................................................................................................ 22
NEUROPACE
®
DEPTH LEAD ....................................................................................................................... 22
LEAD COMPONENT AND ACCESSORIES ....................................................................................................... 23
NEUROPACE
®
PROGRAMMER .................................................................................................................... 23
TELEMETRY WAND .................................................................................................................................... 24
NEUROPACE
®
PATIENT DATA MANAGEMENT SYSTEM ................................................................................. 24
STERILIZATION, STORAGE, AND HANDLING ................................................................................................. 25
RNS
®
SYSTEM LONGEVITY ........................................................................................................................ 26
PRODUCT REGISTRATION .......................................................................................................................... 28
CLINICAL USE OF THE RNS
®
SYSTEM .................................................................................................. 29
IDENTIFYING CANDIDATES FOR THE RNS
®
SYSTEM THERAPY ...................................................................... 29
LOCALIZING THE SEIZURE FOCUS AND PLANNING LEAD LOCATION .............................................................. 29
PATIENT TRAINING .................................................................................................................................... 30
OVERVIEW OF IMPLANTATION AND PROGRAMMING OF THE RNS
®
SYSTEM ................................................... 30
Implanting the RNS
®
Neurostimulator and Leads .............................................................................. 30
Recommended Initial Detection and ECoG Storage Settings ............................................................ 30
Recommended Initial Responsive Therapy Settings ......................................................................... 31
Modifying Detection and Responsive Therapy Settings..................................................................... 32
SURGICAL PROCEDURES ....................................................................................................................... 33
PRE-IMPLANT ............................................................................................................................................ 33
RECOMMENDED IMPLANT PROCEDURE FLOW CHART .................................................................................. 35
RECOMMENDED NEUROPACE
®
DEPTH LEAD IMPLANTATION AND FIXATION .................................................. 36
RECOMMENDED NEUROPACE
®
CORTICAL STRIP LEAD IMPLANTATION AND FIXATION .................................... 39
RECOMMENDED RNS
®
NEUROSTIMULATOR IMPLANTATION PROCEDURE ..................................................... 40
CONNECTING THE RNS
®
NEUROSTIMULATOR TO THE IMPLANTED LEAD(S) ................................................... 44
REPLACING / EXPLANTING THE RNS
®
SYSTEM ........................................................................................... 48
CHANGING THE LEADS THAT ARE CONNECTED TO THE NEUROSTIMULATOR .................................................. 51
PROGRAMMING INSTRUCTIONS ............................................................................................................ 54
LOGGING ONTO THE NEUROPACE
®
PROGRAMMER ...................................................................................... 54
TESTING THE WAND SIGNAL ...................................................................................................................... 54
INTERROGATING THE RNS
®
NEUROSTIMULATOR ........................................................................................ 54
IMPEDANCE MEASUREMENTS ..................................................................................................................... 55
BATTERY VOLTAGE MEASUREMENTS ......................................................................................................... 55
CAPTURING REAL-TIME ECOGS ................................................................................................................. 55
OBTAINING NEUROSTIMULATOR ACTIVITY INFORMATION ............................................................................. 56
REVIEWING ECOG RECORDS RETRIEVED FROM THE RNS
®
NEUROSTIMULATOR .......................................... 56
DELIVERING TEST STIMULATIONS ............................................................................................................... 57
SYNCHRONIZING THE PROGRAMMER WITH THE NEUROPACE
®
PATIENT DATA MANAGEMENT SYSTEM ........... 58
PATIENT INFORMATION AND PHYSICIAN EMERGENCY CONTACT INFORMATION .............................................. 59