Download RNS System User Manual

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TABLE OF CONTENTS
INTRODUCTION........................................................................................................................................... 5
CONTACTING NEUROPACE .......................................................................................................................... 5
ABOUT THIS MANUAL ................................................................................................................................... 5
RNS® SYSTEM ............................................................................................................................................. 9
INDICATIONS ............................................................................................................................................... 9
CONTRAINDICATIONS ................................................................................................................................... 9
WARNINGS AND PRECAUTIONS .................................................................................................................. 10
IMPLANTED RNS® SYSTEM ........................................................................................................................ 19
RNS® SYSTEM DESCRIPTION .................................................................................................................... 19
RNS® NEUROSTIMULATOR ........................................................................................................................ 22
RNS® SYSTEM COMPONENTS AND ACCESSORIES ...................................................................................... 22
NEUROPACE® CORTICAL STRIP LEAD ........................................................................................................ 23
NEUROPACE® DEPTH LEAD ....................................................................................................................... 23
LEAD COMPONENT AND ACCESSORIES ....................................................................................................... 24
NEUROPACE® PROGRAMMER .................................................................................................................... 24
TELEMETRY WAND .................................................................................................................................... 25
NEUROPACE® PATIENT DATA MANAGEMENT SYSTEM ................................................................................. 25
STERILIZATION, STORAGE, AND HANDLING ................................................................................................. 26
RNS® SYSTEM LONGEVITY ........................................................................................................................ 27
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 .................................................................................. 36
RECOMMENDED NEUROPACE® DEPTH LEAD IMPLANTATION AND FIXATION .................................................. 37
RECOMMENDED NEUROPACE® CORTICAL STRIP LEAD IMPLANTATION AND FIXATION .................................... 40
RECOMMENDED RNS® NEUROSTIMULATOR IMPLANTATION PROCEDURE ..................................................... 41
CONNECTING THE RNS® NEUROSTIMULATOR TO THE IMPLANTED LEAD(S)................................................... 45
REPLACING / EXPLANTING THE RNS® SYSTEM ........................................................................................... 49
CHANGING THE LEADS THAT ARE CONNECTED TO THE NEUROSTIMULATOR .................................................. 52
PROGRAMMING INSTRUCTIONS............................................................................................................ 55
LOGGING ONTO THE NEUROPACE® PROGRAMMER ...................................................................................... 55
TESTING THE WAND SIGNAL ...................................................................................................................... 55
INTERROGATING THE RNS® NEUROSTIMULATOR ........................................................................................ 55
IMPEDANCE MEASUREMENTS ..................................................................................................................... 56
BATTERY VOLTAGE MEASUREMENTS ......................................................................................................... 56
CAPTURING Real-time ECoGs ................................................................................................................. 56
OBTAINING NEUROSTIMULATOR ACTIVITY INFORMATION ............................................................................. 57
REVIEWING ECOG RECORDS RETRIEVED FROM THE RNS® NEUROSTIMULATOR .......................................... 57
DELIVERING TEST STIMULATIONS ............................................................................................................... 58
SYNCHRONIZING THE PROGRAMMER WITH THE NEUROPACE® PATIENT DATA MANAGEMENT SYSTEM ........... 59
PATIENT INFORMATION AND PHYSICIAN EMERGENCY CONTACT INFORMATION .............................................. 60
RNS® System User Manual