Neuropace RNS System Manual de usuario

Rev Date: 2019-01 DN 1017309 Rev 4

RNS®System User Manual

This Manual supports:

•RNS®Neurostimulator: model RNS-300M with firmware version 7.0

•NeuroPace®Cortical Strip Lead: models CL-315-10, CL-325-10, CL-335-10

•NeuroPace®Depth Lead: models DL-330-3.5, DL-330-10, DL-344-3.5,

DL-344-10

•NeuroPace®Programmer: model PGM-300 with software version 1.6

FCC Information

The following is communications regulation information on the model RNS-300M

neurostimulator and model W-02 wand.

Neurostimulator FCC ID: WBWRF300

Wand FCC ID: WBW5200 or WBW902

This device complies with Part 15 of the FCC Rules. Operation is subject to the

following two conditions: (1) This device may not cause harmful interference, and (2)

this device must accept any interference received, including interference that may

cause undesired operation.

IMPORTANT: Changes or modifications to this product not expressly approved by

NeuroPace, Inc. could void the FCC Certification, and negate your authority to operate

them.

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled

environment. This transmitter must not be co-located or operating in conjunction with

any other antenna or transmitter.

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 ECOGRECORDS 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

Table of Contents 2

RNS®System User Manual

Entering Patient Information into the Programmer............................................................................. 59

Entering Physician Emergency Contact Information.......................................................................... 59

Programming Information ................................................................................................................... 59

ASSIGNING LEAD LABELS AND CREATING THE MONTAGE............................................................................. 59

Assigning the Lead Labels ................................................................................................................. 59

Recommended Initial Lead Labels ..................................................................................................... 61

Creating a Montage ............................................................................................................................ 62

Recommended Initial Montage settings ............................................................................................. 62

Programming the Newly selected Settings ........................................................................................ 63

SETTING UP ECOGSTORAGE.................................................................................................................... 63

Selecting ECoG Storage Settings ...................................................................................................... 63

Recommended Initial ECoG Storage Settings ................................................................................... 64

Recommended Modifications to ECoG Storage Settings .................................................................. 66

Programming the Newly Selected ECoGs Storage Settings.............................................................. 67

SETTING UP DETECTION ............................................................................................................................ 68

Enabling, Disabling, or Changing the Detection Settings .................................................................. 68

Recommended Initial Detection Settings ........................................................................................... 69

Recommended Modifications to Detection Settings........................................................................... 70

Programming the Newly Selected Detection Settings........................................................................ 74

SETTING UP RESPONSIVE THERAPY ........................................................................................................... 75

Enabling, Disabling, or Changing Responsive Therapy..................................................................... 76

Recommended Initial Responsive Therapy Settings ......................................................................... 77

Recommended Modifications to Responsive Therapy Settings......................................................... 80

Programming the Newly Selected Settings ........................................................................................ 80

REVIEWING REPORTS................................................................................................................................ 81

MAGNET..................................................................................................................................................... 82

PATIENT FOLLOW-UP ACTIVITIES ......................................................................................................... 83

TROUBLESHOOTING................................................................................................................................ 84

DAMAGED PRODUCTS ............................................................................................................................... 84

GENERAL TROUBLESHOOTING ACTIVITIES .................................................................................................. 84

Abnormal Lead Impedance (greater than 3500 Ohms or less than 250 Ohms) ................................ 84

Insufficient Charge.............................................................................................................................. 86

Noise, Artifacts, Poor Signal Displayed, or No Signal Displayed in Real-time ECoG........................ 86

Poor or No Communication Between the RNS®Neurostimulator and the Programmer.................... 87

Programmer Turns OFF or Freezes................................................................................................... 88

Low Battery Measurement ................................................................................................................. 88

Impedance Measurement was Rejected / Test Request was Rejected............................................. 88

RNS®Neurostimulator Reset (DC Leak Detected) ............................................................................ 88

SPECIFICATIONS AND CHARACTERISTICS.......................................................................................... 90

RNS®NEUROSTIMULATOR ........................................................................................................................ 90

RNS®SYSTEM WIRELESS ......................................................................................................................... 91

RNS®SYSTEM LEADS............................................................................................................................... 91

IMPLANTABLE RNS®SYSTEM COMPONENT AND ACCESSORY MATERIALS .................................................... 92

NEUROPACE®PROGRAMMER .................................................................................................................... 92

WAND (MODEL W-02)............................................................................................................................... 92

ELECTROMAGNETIC EMISSIONS AND IMMUNITY ........................................................................................... 93

SYSTEM PRODUCTS, COMPONENTS, ACCESSORIES, AND TOOLS ................................................ 98

GLOSSARY .............................................................................................................................................. 101

INDEX ....................................................................................................................................................... 107

RNS®System User Manual

Explanation of symbols on product or package labeling

Refer to the appropriate product for symbols that apply.

Caution

Do Not Resterilize

MR Unsafe

Prescription Only

Non-Pyrogenic

Single Use

Sterilized Using Ethylene Oxide

Use

Temperature limits during use

Storage

Temperature limits during storage or transport

Manufacturer

Serial number

Type BF applied part

RNS®System User Manual

Class II electrical protection

Direct current (DC) 5 V (volts), 0.5 A

(amperes)

IP22

Ingress protection ratings: Level 2 for solid

objects, which means testing confirms the

device enclosure prevents ingress (entry) of

items greater than 12.5 mm (~1/2 inch), such

as fingers or similar objects; Level 2 for liquids,

which means testing confirms vertically

dripping water shall have no harmful effect

when the enclosure is tilted at an angle up to

15° from its normal position.

Ethernet Connection (Network Connection)

Proposition 65, a State of California voter initiative, requires the following notice:

WARNING: This product can expose you to chemicals including ethylene oxide, which is

known to the State of California to cause cancer and birth defects or other reproductive harm.

For more information go to www.P65Warnings.ca.gov.

Introduction 5

RNS®System User Manual

INTRODUCTION

CONTACTING NEUROPACE

All questions or concerns regarding the NeuroPace®RNS®System should be forwarded to:

NeuroPace, Inc.

455 N. Bernardo Ave.

Mountain View, CA 94043

Customer Support: 1-866-726-3876

(Toll Free in the United States)

Fax: 650-237-2855

Website: www.NeuroPace.com

ABOUT THIS MANUAL

This manual is intended to provide guidelines for implanting the RNS®System, including the

NeuroPace®RNS®Neurostimulator, NeuroPace®Cortical Strip Leads and NeuroPace®Depth Leads,

and instructions for using the NeuroPace®Programmer.

Manual Contents

•Introduction - Overview of the typographical conventions and contents of the manual

•RNS®System Description - Indications, contraindications, product descriptions, theory of

system operation, warnings, and precautions

•Clinical Use of the RNS®System - Physician and center access, identifying candidates,

pre-surgical planning, patient training, overview of implantation and initial programming

recommendations

•Surgical Procedures - Instructions for implanting the RNS®System

•Instructions for Use - Description of the settings available in the neurostimulator and

instructions for programming, instructions for individualizing patient detection settings,

instructions for individualizing patient therapy settings

•Patient Follow-Up - Guidelines for follow-up appointments, follow-up activities, and patient

counseling

•Troubleshooting - Information that may be helpful in solving problems encountered while

implanting or operating the RNS®System

•Specifications - List of each product with its mechanical and electrical characteristics

•Glossary - Alphabetical list of terms used in the manual with their definitions

Introduction 6

RNS®System User Manual

Typographic Conventions

This manual uses different formats and symbols to distinguish instructions, warnings, precautions,

notes, lists, and figures.

WARNING: WARNING TITLE

Warnings alert the user to serious adverse events and potential safety hazards and

situations that may cause injury.

Precaution: PRECAUTION TITLE

Precautions alert the user to exercise special care in the safe and effective use of the

RNS®System.

Note: Notes provide additional information that is particularly useful or important.

1. Numbered paragraphs contain instructions that provide explanations and/or procedural

information.

•Bullet points indicate items in a list.

Figure: Statements regarding a figure are located below the figure between double lines such as this.

Bold italicized text refers the user to a specific location in this manual for further details.

BOLD SMALL CAPS assist the user in navigating to the appropriate tab or button on the NeuroPace®

Programmer screen.

Introduction 7

RNS®System User Manual

The tabs are displayed on the NeuroPace®Programmer screen as follows:

Tab

Page

Button

Responsive Neurostimulator System 8

RNS®System User Manual

RNS®SYSTEM

INDICATIONS

The RNS®System is an adjunctive therapy in reducing the frequency of seizures in individuals 18

years of age or older with partial onset seizures who have undergone diagnostic testing that localized

no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and

currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and /

or secondarily generalized seizures). The RNS®System has demonstrated safety and effectiveness

in patients who average 3 or more disabling seizures per month over the three most recent months

(with no month with fewer than two seizures), and has not been evaluated in patients with less

frequent seizures.

CONTRAINDICATIONS

The RNS®System is contraindicated for:

•Patients at high risk for surgical complications such as active systemic infection, coagulation

disorders (such as the use of anti-thrombotic therapies) or platelet count below 50,000.

•Patients who have medical devices implanted that deliver electrical energy to the brain.

•Patients who are unable, or do not have the necessary assistance, to properly operate the

NeuroPace®Remote Monitor or magnet.

The following medical procedures are contraindicated for patients with an implanted RNS®System.

Energy from these procedures can be sent through the implanted brain stimulation system and cause

permanent brain damage which may cause severe injury, coma, or death. Brain damage can occur

from any of the listed procedures even if the RNS®Neurostimulator is turned off or if the leads are not

connected to the neurostimulator, and can occur even if the neurostimulator has been removed and

any leads (or any part of a lead) or the cranial prosthesis remain.

•MR imaging is contraindicated for patients with an implanted RNS®System. Do not perform an

MRI on a patient with any implanted RNS®Neurostimulator or lead (or any portion of a lead).

Even if the neurostimulator has been removed, you should not have an MRI if any part of a lead

or the cranial prosthesis is still implanted.

The RNS®System is MR Unsafe. Testing has not been performed to define conditions of use to

ensure safety of the RNS®System in an MR environment.

•Diathermy procedures are contraindicated in patients implanted with an RNS®Neurostimulator

and associated leads. (Diathermy is any treatment that uses high-frequency electromagnetic

radiation, electric currents, or ultrasonic waves to produce heat in body tissues.) Patients

absolutely CANNOT be treated with any type of shortwave, microwave, or therapeutic ultrasound

diathermy device whether or not it is used to produce heat. These treatments should not be

applied anywhere on the body.

•Electroconvulsive Therapy (ECT) is contraindicated for patients with an implanted RNS®System.

•Transcranial Magnetic Stimulation (TMS) is contraindicated for patients with an implanted RNS®

System.

WARNINGS AND PRECAUTIONS

WARNINGS -CLINICAL USE

WARNING: PHYSICIAN AND CENTER ACCESS TO THE RNS®SYSTEM

The RNS®System should only be implanted by neurosurgeons with adequate

experience in the implantation of subdural and stereotactic implantation of

intraparenchymal electrodes and in the surgical treatment of intractable epilepsy. The

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