Neuropace RNS 5000, PDMS 4340 User Programming Manual

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RNS® System Programming Manual

For the RNS® Tablet Model 5000 and the

Patient Data Management System (PDMS) Model 4340

18 NeuroPace, Inc.

DN 1017919 Rev 2

Rev Date: 2018-06

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ABOUT THIS MANUAL

This manual includes instructions for use for:

• The RNS

• The NeuroPace

Note: The RNS RNS-300M and model RNS-320.

Note: The term “programmer” as used in this manual is a generic term that refers to either the RNS

Note: Images in this manual are representative and may vary in detail from what a particular user experiences.

Tablet model 5000 with software version 1.8

Patient Data Management System model 4340

Tablet model 5000 is compatible with the RNS® Neurostimulator model

Tablet or the NeuroPace® Programmer (laptop computer).

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iii

FCC INFORMATION

The following is communications regulation information on the neurostimulator models RNS-300M and RNS-320,and wand model W-02.

• Neurostimulator model RNS-300M FCC ID: WBWRF300

• Neurostimulator model RNS-320 FCC ID: WBWRF320

• Wand FCC ID: WBW902

These components comply with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) These devices may not cause harmful interference, and (2) these devices must accept any interference received, including interference that may cause undesired operation.

IMPORTANT: Changes or modifications to these components not expressly approved by NeuroPace, Inc. could void the FCC Certification, and negate your auth or it y 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 operati ng in conjunc tio n with any other antenna or transmitter.

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SYMBOLS

Explanation of symbols on product or package labeling

Caution

o Not Resterilize

Unsafe

Prescription Only

on-Pyrogenic

ingle Use

terilized Using Ethylene Oxide

emperature Limits

thernet 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 an d birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

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TABLE OF CONTENTS

ABOUT THIS MANUAL ......................................................................................................II

FCC INFORMATION ........................................................................................................ III

SYMBOLS ..................................................................................................................... IV

INTRODUCTION ............................................................................................................. 4

DEVICE DESCRIPTION ..................................................................................................... 4

RNS NEUROPACE

PRODUCTS AND ACCESSORIES ....................................................................................... 4

CONTACTING NEUROPACE ............................................................................................. 5

TYPOGRAPHIC CONVENTIONS ......................................................................................... 5

WARNINGS AND CAUTIONS – PROGRAMMER .................................................................... 6

STERILIZATION AND STORAGE ........................................................................................ 8

TABLET ............................................................................................................... 4

PATIENT DATA MANAGEMENT SYSTEM ...................................................... 4

Product Storage .................................................................................................................................... 8

Explant and Disposal ............................................................................................................................ 8

Wand Cleaning and Sterilization .......................................................................................................... 8

Electrostatic Discharge (ESD) / Static Electricity ................................................................................. 9

RNS® TABLET INSTRUCTIONS .................................................................................. 10

POWER ON THE TABLET ............................................................................................... 10

CONNECT AND LOGIN OVERVIEW .................................................................................. 10

FUNCTIONALITY WITH AND WITHOUT A PDMS CONNECTION ............................................ 11

CONNECT TO THE INTERNET FOR PDMS ACCESS ........................................................... 11

Mobile Broadband Works Automatically............................................................................................. 11

Steps to Connect to a Wi-Fi Network ................................................................................................. 12

If You Lose Network Connectivity ...................................................................................................... 13

TABLET ...................................................................................... 14

INTERROGATE THE RNS

NEUROSTIMULATOR ............................................................... 16

DATA RETENTION AND ACCESS ON THE NEUROSTIMULATOR, PROGR AMME R AND PDMS . 17

Programmed Settings ......................................................................................................................... 17

Storage of ECoGs and Neurostimulator Activity (Diagnostics) .......................................................... 17

HOME SCREEN ............................................................................................................ 18

NEUROSTIM INFO SCREEN ............................................................................................ 20

Electrode Impedance and Battery Voltage ......................................................................................... 22

ACTIVITY SCREEN ........................................................................................................ 23

Activity Histogram Viewing Options .................................................................................................... 24

View Neurostim Settings .................................................................................................................... 25

View Event List ................................................................................................................................... 28

Types of Reports ................................................................................................................................ 28

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Advanced Views ................................................................................................................................. 29

ECOG LIBRARY SCREEN .............................................................................................. 29

LIVE ECOGS SCREEN .................................................................................................. 31

CREATE THE RECORDING MONTAGE ............................................................................. 32

Identifying Ports, Leads and Electrodes on the Neurostimulator ....................................................... 33

Creating the Montage ......................................................................................................................... 34

Recommended Initial Montage Settings............................................................................................. 35

Program the Neurostimulator with the New Settings ......................................................................... 37

SET UP ECOG CAPTURE .............................................................................................. 38

Selecting ECoG Capture Settings ...................................................................................................... 38

Recommended Initial ECoG Capture Settings ................................................................................... 41

Program the Neurostimulator with the New Settings ......................................................................... 43

RECOMMENDATION FOR REVIEW OF INITIAL ECOG CAPTURE SETTINGS .......................... 43

CONFIGURE PATTERN DETECTION: DEFINE AND MODIFY DETECTION SETTINGS ............... 44

Phase 1: Select a Default Detection Set upon First Use.................................................................... 45

Phase 2: Define a Pattern Detection Set ........................................................................................... 48

Phase 3: Customize Pattern Detection .............................................................................................. 52

DETECTION TOOLS AND DETECTORS ............................................................................. 56

Detection Tools and Detectors ........................................................................................................... 56

Power Change Detector ..................................................................................................................... 57

Rhythmic Activity Detector ................................................................................................................. 59

Spike Activity Detector ....................................................................................................................... 60

Bandpass Detection Tool ................................................................................................................... 61

Area Detection Tool ............................................................................................................................ 62

Advanced Controls ............................................................................................................................. 63

SHARE AND/OR DOWNL OAD A DETECTION SET .............................................................. 64

Steps to Share a Detection Set .......................................................................................................... 64

Steps to Download a Detection Set to the Tablet .............................................................................. 66

OVERVIEW OF RESPONSIVE THERAPY ........................................................................... 69

CONFIGURE RESPONSIVE THERAPY .............................................................................. 70

Optional Advanced Settings ............................................................................................................... 74

Test Stimulation Before Enabling ....................................................................................................... 77

Enable Therapy: Review & Program .................................................................................................. 78

Recommended Initial Responsive Therapy Settings ......................................................................... 79

Recommended Therapy Modifications After Observing Clinical Response....................................... 80

EXPORT AND IMPORT DEVICE SETTINGS FOR NEUROSTIMULATOR REPLACEMENT ............ 81

Transfer Compatibility......................................................................................................................... 81

Export Neurostimulator Set tings ......................................................................................................... 81

Import Neurostimulator Settings ......................................................................................................... 82

PATIENT LIST ON TABLET AND THE PDMS ON A PERSONAL COMPUTER ........ 84

PDMS ACCESS ON A PERSONAL COMPUTER ................................................................. 85

PDMS PROFILE AND SETTINGS .................................................................................... 85

PATIENT & NEUROSTIM INFO ........................................................................................ 88

NEUROSTIM SETTINGS.................................................................................................. 88

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ACTIVITY ..................................................................................................................... 90

ECOG LIBRARY ........................................................................................................... 90

LIVE ECOGS ............................................................................................................... 90

PATIENT FOLLOW-UP ACTIVITIES ............................................................................ 91

TROUBLESHOOTING .................................................................................................. 92

Network Connectivity Problems ......................................................................................................... 92

Abnormal Lead Impedance (greater than 3500 Ohms or less than 250 Ohms) ................................ 92

Insufficient Charge.............................................................................................................................. 95

Noise, Artifacts, Poor Signal Displayed, or No Signal Displayed in Live ECoG................................. 95

Poor or No Communication Between the RNS® Neurostimulator and the RNS® Tablet ................... 96

Tablet Does Not Turn On ................................................................................................................... 97

Tablet Freezes or Does Not Turn Off ................................................................................................. 97

Tablet Shuts Down ............................................................................................................................. 97

Impedance Measurement Was Rejected / Test Request Was Rejected ........................................... 97

SPECIFICATIONS AND CHARACTERISTICS ............................................................ 98

RNS

TABLET ............................................................................................................. 98

TABLET WIRELESS ....................................................................................................... 98

RNS

SYSTEM WIRELESS ............................................................................................ 99

ELECTROMAGNETIC EMISSIONS AND IMMUNITY .............................................................. 99

Hospital or Medical Environments ...................................................................................................... 99

Home, Work or Public Environments ............................................................................................... 100

Guidance and Manufacturer’s Declaration ....................................................................................... 100

Emissions and Immunity Information ............................................................................................... 101

GLOSSARY ................................................................................................................ 105

INDEX ......................................................................................................................... 110

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Introduction 4

Item

Model Number

RNS® Tablet (with attached case)

5000

Stylus

AC Adapter

Carrying Bag

Used With

Wand

W-02

INTRODUCTION

DEVICE DESCRIPTION

• RNS® Tablet model 5000 with software version 1.8

• NeuroPace

RNS

TABLET

Patient Data Management System model 4340

The RNS® Tablet includes a tablet computer that runs proprietary NeuroPace software, and uses custom telemetry components to communicate with the RNS

Neurostimulator. Clinicians can use the tablet to program how the neurostimulator operates. Settings include, but are not limited to, the implanted system configuration, detection settings adapted to the patient's ECoG patterns storage, and settings of the therapies. Clinicians can also use the tablet to review previously retrieved neurostimulator activity information, perform detection analysis, and communicate with the NeuroPace

, settings for ECoG record

Patient Data Management System (PDMS) via the Internet.

Note: The term “programmer” as used in this manual is a generic term that refers to either the

RNS

Tablet or the NeuroPace® Programmer (laptop computer).

NEUROPACE

PATIENT DATA MANAGEMENT SYSTEM

The Patient Data Management System (PDMS) maintains patient and product data obtained from the programmer and remote monitor. Authorized users may access the PDMS via the Internet using a personal computer. An electronic signature in the form of a username and password are required for user authentication.

PRODUCTS AND ACCESSORIES

Note: Manuals and other literature are not listed below.

RNS® Tablet Kit

Model 5001

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Introduction 5

This manual contains information applicable to the RNS® Tablet, which is used to program how the RNS

Neurostimulator operates. It includes information about the secure Patient Data Management System (PDMS) database, which is accessible using the tablet or a web browser on a personal computer.

Refer to the RNS

System manual for additional device descriptions, device specifications, and

indications for use, contraindications, warnings, cautions, and instructions for use.

All NeuroPace

manuals are available at www.NeuroPace.com or by contacting NeuroPace,

Inc. (see Contacting NeuroPace on page 4). Refer to the clinical summary booklet for information on the clinical study results of the RNS

System and advers e event dat a.

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: 866-726-3876 (Toll Free in the United Stat es ) Website: www.neuropace.com

TYPOGRAPHIC CONVENTIONS

This manual uses the following typographic conventions.

WARNING: W

Caution: Caution Title

Note: Notes provide additional information.

1. Numbered lists are used to identify a sequence of steps.

This format is used to identify figure titles and descriptions

BOLD SMALL CAPS indicate on-screen text, like the names of screens, buttons and fields.

Note: Software version numbers found on screenshots in this manual are provided for illustrative purposes only and may not be the same as the version number you see on screen.

ARNING TITLE

Warnings alert you to serious adverse events and potential safety hazards and situations that may cause injury.

Cautions alert you to exercise special care.

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Introduction 6

WARNINGS AND CAUTIONS – PROGRAMMER

Note: See the RNS® System manual for warnings and cautions regarding other components of the RNS

WARNING: P

System.

HYSICIAN 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

RNS

System should only be used by neurologists or neurosurgeons with adequate experience in the management of intractable epilepsy and in the localization of epileptic foci, including the use of scalp and intracranial electrodes.

Neurologists and neurosurgeons using the RNS NeuroPace RNS

RNS® System training program. To qualify to manage patients with the

System, physicians must demonstrate specific expertise related to epilepsy,

System must have completed the

video-EEG monitoring, interpretation of electrocorticograms (ECoGs), the pharmacology of antiepileptic medications and selection of patients for epilepsy surgery. Implantation of the RNS

System should be performed only by qualified neurosurgeons at centers capable of providing comprehensive epilepsy care, i.e. “Comprehensive Epilepsy Centers.” These centers should have the expertise to provide diagnostic services that include video-EEG monitoring with scalp and intracranial electrodes and neuroimaging, and are experts in the treatment of epilepsy with antiepileptic medications, epilepsy surgery, and devices.

WARNING:

MANAGEMENT OF PATIENTS WITH THE RNS® SYSTEM BY PHYSICIANS AT CENTERS THAT DO

NOT PROVIDE THE SERVICES PROVIDED AT COMPREHENSIVE EPIL EPSY CENTERS

WARNING: P

WARNING: R

In some instances, post-implant programming may be conducted by neurologists meeting the experience and certification requirements for neurologists at Comprehensive Epilepsy Centers, but who are not practicing in such centers. This situation might occur if the patient is not able to travel to a Comprehensive Epilepsy Center for regular follow-up (e.g. because of distance from the Center or limited access to transportation). These neurologists will be qualif ied b y NeuroPac e to provide post-implant programming. After NeuroPace

RNS® System training is complete, the qualified programming neurologist may receive external NeuroPace products (programmer, remote monitor).

OTENTIAL SHOCK

Submerging any part of the programmer, or operating the programmer in or near a wet environment, may result in an electrical shock.

The programmer must be disconnected from the electrical outlet prior to cleaning to avoid the potential of electrical shock.

Electrical shock may occur if the programmer AC adapter and power cord are not properly connected to a grounded power source.

ADIO FREQUENCY IDENTIFICATION (RFID) INTERFERENCE

Sources of RFID can result in signals that appear as ECoG activity to the neurostimulator. Signals that appear as ECoG activity could also result in delivering

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Introduction 7

the programmed stimulation to the patient (per the device detection programming). The physician should be aware of possible sensing artifacts when assessing the ECoG recordings. Potential sources of RFID may occur in a health care environment, retail stores, public libraries, airports and business environments.

Refer to Electromagnetic Emissions and Immunity on page 99 for more information.

WARNING: S

WARNING: N

WARNING: P

ECURITY AND ELECTRONIC TRACKING SYSTEMS

Security screening devices (such as theft detectors, security tag deactivators, and airport security screening devices) can result in signals that appear as ECoG activity to the neurostimulator. Signals that appear as ECoG activity could also result in delivering the programmed stimulation to the patient (per the device detection programming). Such devices may be found at retail stores, public libraries and airports. The physician should be aware of possible sensing artifacts when assessing the ECoG recordings. Patients should be instructed to walk through the center of such security screening units without stopping, when possible, and exit the area of the screening device as soon as possible.

EUROPACE COMPONENTS

Use of accessories, transducers, and cables other than those pro vided b y Neur o Pace could result in increased electromagnetic emissions or decreased electromagnetic immunity of the RNS

ORTABLE AND MOBILE RADIO FREQUENCY (RF) COMMUNICATIONS EQUIPMENT

System and result in improper operation.

Portable and mobile RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of the RNS performance of the RNS

System, including cables. Otherwise, degradation of the

System could result.

WARNING: N

EUROPACE® EQUIPMENT PLACEMENT

Use of NeuroPace to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, the NeuroPace

equipment (for example, remote monitor or programmer) adjacent

equipment and other

equipment should be observed to verify that the y are operati ng normally.

Caution: Telemetry Artifact

Telemetry may produce an electrographic artifact. If responsive therapy is enabled with a sensitive detection set, detection of the electrographic artifact may occur resulting in therapy delivery. The physician should be aware of possible sensing artifacts when assessing the ECoG recordings.

Caution: Afterdischarge Activity

If evidence of afterdischarge activity resulting from stimulation is seen either on stored ECoGs or during test stimulation delivery, stimulation parameters should be adjusted to prevent such occurrence.

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Introduction 8

Caution: Programmer Failure

As with any electronic device, the programmer may be damaged or malfunction if the programmer AC adapter and power cord are not properly connected to a grounded power source.

Caution: Incompatibility of Programmer with Other Medical Devices

The effects of using the programmer to interrogate other electronic, programmable devices such as pacemakers, defibrillators, cochlear implants, and other neurostimulators or CPAP machines are unknown. It could result in reprogramming of the other device and therefore, the physicians familiar with each device should check the programmed parameters of each device before the patient is discharged and after each programming session of either device.

Caution: Electronic Interference

Communications between the programmer and the implanted neurostimulator may be interrupted by emissions from nearby electronic devices. Examples of sources of EMI are lithotripsy, computer monitors, cellular telephones, motorized wheel chairs, x-ray equipment and other monitoring equipment. Interruption of telemetry can result in incomplete communication. If EMI disrupts programming, move the programmer away from the likely source of EMI. Refer to Poor or No Communication Between the

RNS

Neurostimulator and the RNS® Tablet (page 96) for more information.

Caution: Placement of the Programmer Power Cord

Make sure nothing rests on the programmer power cord and that the cord is not located where it can be tripped over or stepped on.

Caution: Heating

The programmer’s AC adapter may become hot during normal operation. Use care when handling during or immediately after operation.

STERILIZATION AND STORAGE

Product Storage

Components should be stored in a clean and secure area with a room temperature of approximately 14 to 28 degrees Celsius.

Explant and Disposal

Program all detection and therapy functions to DISABLED prior to explanting and shipping the RNS Neurostimulator. Return the explanted neurostimulator and leads to NeuroPace. NeuroPace will provide shipping containers if requested.

DO NOT incinerate the neurostimulator; explosion can occur if the neurostimulator is exposed to incineration or cremation temperatures.

Wand Cleaning and Sterilization

The wand can be cleaned by wiping with water. It can be placed in a sterile bag for use in the sterile field. DO NOT STERILIZE the wand.

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Introduction 9

Electrostatic Discharge (ESD) / Static Electricity

The ports on the tablet may be sensitive to electrostatic discharge / static electricity. Handle the tablet ports carefully. If exposed to electrostatic discharge, the tablet may experience telemetry artifacts or errors, or may freeze. In the event of a tablet freeze, refer to Tablet Freezes

on page 97.

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Tablet Instructions 10

RNS

This chapter primarily addresses use of the tablet during an interactive programming session, that is, when the clinician uses the wand for communication between the neurostimulator and tablet. For information on using the PDMS apart from an interactive programming session, either using the tablet or using a web browser on a personal computer, see Patient List on Tablet and the PDMS on a Personal Computer on page 84.

TABLET INSTRUCTIONS

POWER ON THE TABLET

When interacting with a patient, the tablet should be used on battery power only. Make sure the tablet is sufficiently charged for use before powering on.

Press and hold the power button on the upper right side of the tablet. After 2-3 seconds, the tablet beeps to indicate it is powering on.

CONNECT AND LOGIN OVERVIEW

Access to all of the functionality of the tablet requires an Internet connection and two logins, in this order:

1. Connect to the Internet via Wi-Fi or mobile broadband on the tablet. Mo bi le broa dban d works automatically. To connect to Wi-Fi, see Steps to Connect to a Wi-Fi Network on page 12. Alternatively, the tablet computer can also support use of a docking station that has an Ethernet connector (wired connection). Contact NeuroPace customer service if you prefer this alternative.

2. Login to the tablet. NeuroPace provides the initial username and password for this login.

3. Login to the Patient Data Management System (PDMS), which requires the Internet connection established in the first step. NeuroPace also provides the initial username and password for the PDMS. (For PDMS access using a personal computer, select the PDMS link at

www.neuropace.com and log in. For further instructions, see

Computer on page 85.)

Note: Programming functions that are typically performed in the operating room do not require an Internet connection to the PDMS.

You can access all programming functions without connection to the PDMS except the following:

• View stored information such as ECoGs, neurostimulator activity and settings for any patient

• Make a new detection set or adjust parameters of a detection set

For details, see Functionality with and without a PDMS Connection on page 11.

PDMS Access on a Personal

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Tablet Instructions 11

FUNCTIONALITY WITH AND WITHOUT A PDMS CONNECTION

Note: Programming functions that are typically performed in the operating room do not require an Internet connection to the PDMS.

The table below identifies the tablet functions that do not require an Internet connection to the PDMS and those that do.

Function Internet Connection to

the PDMS Required

Interrogate the neurostimulator No

View neurostimulator information and settings downloaded during current

No session, including battery voltage, impedance, stimulation settings, recording montage

Create or change the recording montage No

Set up or adjust ECoG capture settings No

Select and program a default detection set or a custom detection set

No previously saved to the tablet from the PDMS

Select and program all stimulation settings No

View stored information such as ECoGs, neur ostimulator activity and

Yes

settings for any patient

Make a new detection set or adjust parameters of a detection set Yes

CONNECT TO THE INTERNET FOR PDMS ACCESS

When connected to the Internet and logged in to the Patient Data Management System (PDMS), the

RNS

Tablet provides a look-through to the information stored on the PDMS, such as ECoGs, neurostimulator settings and activity. The PDMS is a patient database integrated with the RNS the PDMS is also available using a browser on an y Internet-connected computer. The tablet ships with Wi-Fi enabled, so it can detect available Wi-Fi networks out of the box.

Tablet;

Note: If you attempt to connect to a Wi-Fi network that requires you to go to an Internet website to log in, as in some hotels and coffee shops, you will not be able to log in because the tablet does not have an Internet browser program. As a medical device, its Internet connectivity is restricted to the PDMS only.

The tablet ships with Wi-Fi and mobile broadband enabled.

Mobile Broadband Works Automatically

Mobile broadband is pre-configured by NeuroPace to be on and working, so no further effort is necessary and the tablet will connect to mobile broadband automatically if a signal is available.

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Tablet Instructions 12

Steps to Connect to a Wi-Fi Network

Follow these steps to connect via Wi-Fi to the Internet on the RNS® Tablet.

1. The tablet login screen appears first upon startup. Select a user. The screen prompts you for a username and password and displays the keyboard, but ignore these for now.

2. Touch to select the small symbol that indicates network status. (If necessary, touch outside the login fields to dismiss the keyboard and see the whole screen.)

Figure 1 Touching the network icon at lower left

When a wireless network is available, it looks like the signal strength symbol with an asterisk above it. A different symbol is present if there is no wireless network available. Select it in any case to open the N

ETWORKS panel on the right side of the screen.

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Tablet Instructions 13

3. From this point, Wi-Fi access is the same as on a smartphone or laptop computer: a. Select the desired network and then select C b. Enter the network security key and select N

ONNECT.

EXT. (The security key is your Wi-Fi

password.) The tablet connects if the security key is correct. Internet connection is complete.

If You Lose Network Connectivity

If you lose network connectivity, you will not lose information you already programmed into the neurostimulator or saved to the PDMS, but you will lose information not already programmed into the neurostimulator or saved to the PDMS.

If you are already logged in to the tablet and have lost network connectivity, first log off to return to the login screen: return to the Home screen and touch the circle-X (exit) button at upper right, and then select E

XIT on the PROGRAMMER EXIT dialog. Then follow the Steps to Connect to a Wi-Fi

Network on page 12. If you still cannot connect, contact NeuroPace for further assistance (see Contacting NeuroPace on page 4).

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Tablet Instructions 14

This is the first of two logins. The second one gives you access to the PDMS.

1. The tablet login screen appears first upon startup. Select a user. The screen prompts you for a username and password and displays the keyboard.

TABLET

2. Enter your username and password (initi all y provid ed b y Neuro Pace) and select Enter. Login completes if the password is correct and then the N

EUROPACE LOG IN screen appears, which lets

you login to the PDMS, as described next.

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Tablet Instructions 15

LOG IN TO THE PDMS

The NEUROPACE LOG IN screen appears after tablet login, and whenever you attempt to access functions that require PDMS access, like the P

ATIENT LIST and ECOG LIBRARY.

If Internet not available, select Back

to go to Home screen without

logging into the PDMS.

Figure 2 NeuroPace Log In screen—for PDMS login

To skip PDMS login, select the BACK button in the upper right corner. The Start screen opens.

1. Select the fields to enter the username and pas sword and then select L

OG IN. Login completes

and the Start screen opens (Figure 3).

Figure 3 Start screen

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Tablet Instructions 16

INTERROGATE THE RNS

To interrogate the RNS® Neurostimulator means to identify it, perform routine tests and measurements, and retrieve currently programmed settings and stored data from it. Follow these steps to interrogate:

1. Connect the wand to the USB port on the tablet.

NEUROSTIMULATOR

Figure 4 Tablet with connected wand

2. Place the wand within appr ox imately 1 inch of the neurostimulator, concave side of wand

facing the neurostimulator. Then select I Figure 3). You can also select the green I (see Figure 6.) The wand must be held in place over the neurostimulator for interrogation to succeed.

NTERROGATE from the Start screen (left tile—see

NTERROGATE tile at upper right in the HOME screen

Figure 5 Interrogating neurostimulator dialog—interrogation in progress

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Tablet Instructions 17

The INTERROGATING NEUROSTIMULATOR dialog shows progress and the HOME screen appears when complete. It takes from 10 seconds up to 5 minutes, depending on the amount of data to be retrieved. Interrogation does not significantly drain the neurostimulator battery

The dialog has bars that show the L strength of the communication between the neurostimulator and the tablet. The Q

EVEL and QUALITY of the SIGNAL. The LEVEL measures the

UALITY measures

the absence of electronic interference in the environment. Poor signal level or quality can result in Poor or No Communication Between the RNS® Neurostimul ator and the RNS® Tablet—see page 96 for troubleshooting information.

DATA RETENTION AND ACCESS ON THE NEUROSTIMULATOR, PROGRAMMER AND PDMS

Programmed Settings

The neurostimulator retains its programmed settings until it is programmed again. These include the recording montage, ECoG capture triggers and reservations, and the detection and stimulation settings.

Note: ECoG capture triggers are inactive during programming. Programming clears activity information (diagnostics) and EC oGs stored in the neurostimulator. If there is any new

information, be sure to interrogate the neurostimulator prior to programming.

Storage of ECoGs and Neurostimulator A ctivity (Diagnostics) Between interrogations by the patient or a clinician, the neurostimulator stores ECoGs and

neurostimulator activity events up to its storage limit. (Neuros timulator activity events are also known as diagnostics, which include, for example, detection and stimulation events and magnet swipes.) Once the memory for ECoGs or diagnostics is full, the neurostimulator will store new data by overwriting the oldest ECoG or diagnostics. Reserved ECoGs are overwritten only by newer ECoGs of the same ECoG capture trigger type.

• The limit to the number of ECoGs stored on the neurostimulator depends on the capture

duration you select in the ECoG capture settings (see Set up ECoG Capture on page 37 for details).

• You can make no adjustments that affect the number of neurostimulator activity events that

can be stored. However, the number of events that can be stored is large compared to the number of ECoGs, because the data size of each event is relatively small.

At each interrogation with the remote monitor or programmer, the neurostimulator transfers all stored ECoGs and diagnostics to the programmer or remote monitor, at which point the successfully transferred data is cleared from the neurostimulator.

• If the programmer or remote monitor is not connected to the PDMS (via the Internet), the

transferred data remains on the programmer or remote monitor hard drive. You cannot view ECoGs or diagnostics while stored on the programmer or remote monitor; it must be transferred to the PDMS before you can view it.

• When the programmer is connected to the PDMS (via the Internet), the transferred data is

automatically uploaded to the PDMS and cleared from the programmer memory. When the patient synchronizes using the remote monitor, data is transferred to the PDMS and cleared from the remote monitor. Data is retained on the PDMS.

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Tablet Instructions 18

• L

date and time (24-

hour time)

• L

username

• Tablet battery status (%)

Toolbox button

Wireless Signal button

Note: If automatic upload to the PDMS does not complete successfully, data is not lost. Data is cleared from the programmer or remote monitor only after a successful upload.

HOME SCREEN

The Tablet Home screen is the launch point for all programming activities.

Figure 6 Tablet Home screen

Note: When logged in to the PDMS, changes you make with the tablet are immediately saved to the PDMS. If you lose connectivity, you will not lose information you already programmed into the neurostimulator or saved to the PDMS, but you will lose information not already programmed into the neurostimulator or saved to the PDMS.

The elements in the far upper right of the screen are present on all tablet screens.

AST INTERROGATION

OGGED IN

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Tablet Instructions 19

• WIRELESS SIGNAL button to access the PDMS COMMUNICATION LOG

• TOOLBOX button to access UTILITIES dialog to IMPORT DEVICE and EXPORT DEVICE SETTINGS.

These features are designed to support neurostimulator replacement. For instructions, see Export and Import Device Settings for Neurostimulator Replacement on page 81.

Figure 7 Utilities dialog

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NEUROSTIM INFO SCREEN

Select NEUROSTIM INFO from the HOME screen to open the NEUROSTIM INFO screen.

Figure 8 Neurostim Info screen

The NEUROSTIM INFO screen provides information about the neurostimulator, including:

• At upper left, whether D

ETECTION and STIMULATION are ENABLED or DISABLED and Alerts, if any

• At upper right, MODEL, serial number (S/N) and LAST PROGRAMMED date and time (24-hour time)

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• At middle right, MEASURED BATTERY VOLTAGE with MEASURE button. The early, mid and late life voltage ranges are displayed to give context to the measured voltage. See Significance of Battery Voltage on page 23.

• At lower right, measured impedance for electrodes on the PORT #1 and PORT #2 leads

• Buttons to M

EASURE impedance manually

using the amount of C is measured routinely during

URRENT selected. (It

• A button to C

HANGE RECORDING MONTAGE,

as explained under Creating the Montage on page 34

interrogation.)

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Electrode Impedance and Battery Voltage

Interrogation includes measuring electrode impedance and battery voltage, and these measurements are reported on the N impedance measurement detects insufficient charge for one or more electrodes.

Figure 9 Insufficient charge alert shown on the NEUROSTIM INFO tile and screen

To measure these items again, place the wand within approxim ately 1 inch of the neurostimulator and select the applicable M get there). For impedance measurements, use the C during measurement.

EUROSTIM INFO screen. The NEUROSTIM INFO tile and screen show an alert if the

EASURE button on that screen (select NEUROSTIM INFO from the HOME screen to

URRENT field to adjust the current delivered

Note: The system cannot measure impedance during a detected episode or during therapy delivery. To measure impedance, either wait for the episode or therapy to complete, or disable detection and therapy.

Significance of Impedance Impedance measurements are useful for verifying the integrity of a particular electrode. Each

impedance measurement delivers a single pulse of current between an electrode and the neurostimulator canister (can) to measure the voltage that results as the current flows. Impedance measurements are reported in Ohms (voltage divided by current).

Impedance measurements greater than 3500 Ohms or less than 250 Ohms are considered abnormal. If impedance measurements are abnormally high, there may be insufficient charge to deliver therapy. When this is the case, alerts may appear on the Neurostim Info screen as shown below in Figure 10.

Figure 10 Alerts when there is insufficient charge to deliver therapies

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For troubleshooting information, refer to Abnormal Lead Impedance (greater than 3500 Ohms or less than 250 Ohms) on page 92; and Insufficient Charge on page 95.

Significance of Battery Voltage Normal RNS® Neurostimulator battery voltage measurements are between 2.38 and 3.20 Volts.

When the battery voltage measurement drops to 2.37 Volts or less, neurostimulator replacement is recommended, and the tablet notifies you on screen by showing the elective replacement indicator (ERI).

ACTIVITY SCREEN

Select ACTIVITY from the HOME screen to open the ACTIVITY screen.

Figure 11 Activity screen

Note: You must be logged in to the PDMS to access the ACTIVITY screen. If you are not, the N

EUROPACE LOG IN screen opens when you select ACTIVITY, prompting you to log in. (See Log In

to the PDMS on page 15.) If you are not connected to the Internet, see Connect to the Internet for PDMS Access on page 10.

The upper part of the A

CTIVITY screen is a histogram that shows the number of detection and stimulation

events over time. Swipe left or right over the dates to view earlier or later activity. The lower part of the screen shows (by default) a list of the N

EUROSTIM SETTINGS—detection and stimulation settings—used

over time, one row for each period of time between programming changes, which is called a programming epoch. More view options ar e descr ibe d below .

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Select event types

to layer on graph

Activity Histogram Viewing Options

The interface provides many options for viewing activity.

• Select E events from A or S

TIMULATION ONLY.

POCHS at upper left or right to see

LL EPOCHS, DETECTION ONLY

• Select F flagged with M

INTERROGATION or IMPLANTS.

LAGS at upper right to see events

AGNET SWIPE, OFFICE

• Select NEUROSTIM EVENTS on the left or right sides of the histogram to select items for layering on the graph; you can select multiple items concurrently, up to all items in the upper part of the list. A color legend appears on the left to help you recog ni ze what is on the histo gram.

Vertical lines on top indicate

date ranges of each epoch

Legend

Figure 12 Activity histogram with all events showing and supporting legend on left

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View Neurostim Settings

The lower part of the ACTIVITY screen details the history of detection and stimulation settings used— collectively called N epoch), which are in rows from most recent on top to oldest on the bottom. Drag up the gray separator bar to view more of these settings, which will cover the upper histogram portion. Swipe up on the setting rows to v ie w m or e rows, if they are present.

View options

Date range of

programming

epoch

Select to see

row number

EUROSTIM SETTING S—between each iteration of programming (each programming

Drag up the separator bar to cover histogram

and view more N

EUROSTIM SETTINGS.

Detection set name

—select for details

Figure 13 Activity screen—view detection and stimulation settings used between programming sessions

Date settings

created

Stimulation therapy

settings used

Select CLICK to see

Advanced settings used

At the left end of each row is a blue tile showing the date range when those NEUROSTIM SETTINGS were used. Vertical lines above the histogram correspond to these dates (see Figure 12 above). When you select a blue tile, its row number appears on the tile (see Figure 13 above, row numbers increase as you go down).

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Also the corresponding time period is bracketed in the histogram graph, and the row number and start date appear over the br ack eted time period, if there is enough room on screen (see F helps to relate the programming changes to the device activity.

IGURE 14). This

Programming Start Date

Brackets of

programming epoch

Row number

Figure 14 Activity histogram excerpt showing programming epoch 1 bracketed

Next to the blue tiles, the second column in Figure 13 shows the name of the DETECTION set. Select the name to view its details in the screen that opens (Figure 15). Touch (X) at upper right to close.

Figure 15 Detection set details

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At the right end of each row in Figure 13 is the ADV (Advanced) column. Touch CLICK below ADV to view any advanced settings used in the screen that opens (Figure 16). Touch (X) at upper right to close.

Figure 16 Advanced stimulation therapy settings used

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View Event List

Select EVENT LIST next to NEUROSTIM SETTINGS above the left end of the row (Figure 17) to see a complete list of events for all rows. From there, select links under R on each event. Swipe up or down in the blue column on the left to scroll between programming epochs. Swipe up or down within the event lis t it s elf to s c r oll the list of events.

EPORT TYPES for detailed reports

Select to see event report

Figure 17 Event List selected—lists all events in a Neurostim Settings period, with links to reports

Types of Reports

There are six types of patient reports:

• Interrogation (Initial or Subsequent within the tablet session)

 Interrogation time/dat e

• Programmed Neurostimulator settings

• Event counters (# of detections, stimulations, etc.)

• Event date/time and details

• Programming

• Programming date/time

• Programmed Neurostimulator settings

• Electrode Impedance

• Impedance measurement date/time

• Impedance measurement of each electrode (in ohms)

• Battery Measurement

• Battery measurement date/time

• Battery measurement value (in volts)

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• Therapy Testing (sho ws th erap y testing va lu es )

• ECoG

• ECoG trigger time/date

• ECoG record

• ECoG trigger reason

• ECoG markers (detections, stimulations, etc.)

Advanced Views DETECTION, AVERAGED EVENTS and PROGRAMMING EPOCHS are the advanced views. DETECTION

shows a graph of detection occurrence percentage for each programmed detection pattern since the last change in detection settings. A normalized average number of detected episodes per hour for the last 12 weeks. P

VERAGED EVENTS shows a week by hour histogram of the

ROGRAMMING

EPOCHS shows the history of recent programming epochs, summarizes the settings and activity of

each epoch, and highlights the changes in settings and activity from one epoch to the next.

ECOG LIBRARY SCREEN

It is recommended to review ECoGs stored in the library to assess how early and how often detections occur and the electrographic response to stimulation therapies delivered. Select EC

OME screen to open the ECOG LIBRARY screen, which displays thumbnails of all ECoGs stored for the

current patient.

OG LIBRARY from the

Note: You must be logged in to the PDMS to access the ECoG library. If you are not, the

EUROPACE LOG IN screen opens when you select ECOG LIBRARY, prompting you to log in. (See

Log In to the PDMS on page 15.) If you are not connected to the Internet, see Connect to the Internet for PDMS Access on page 10.

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Triggers filters

Categories filters

Figure 18 ECoG Library screen

Each ECoG is identified by date and time captured and by capture trigger. Newest ECoGs are on the left, older ones toward the right. Swipe left or right to view all ECoGs. You can filter which ECoGs are displayed using T

RIGGERS and CATEGORIES at upper left (Figure 19). Use the FROM and TO fields at

upper right to view ECoGs by date range.

Figure 19 Filter stored ECoGs by triggers and categories

At top center (see Figure 18), you can select ALL, FAVORITES or DETECTION SETS to display ECoGs by those classifications.

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Select a thumbnail to open it in a larger size, as shown below. ECoGs highlight detection and stimulation events. Detected activity appears in blue. Undetected activity appears in black. Colored flags mark specific points of detection or stimulation. You can Z

SSIGN CATEGORY field to assign the ECoG to a category. Select the STAR button at upper right to specify

this ECoG as a favorite, for fast access later using the F

OOM in on the ECoG and increase the GAIN. Use the

AVORITES filter on the ECOG LIBRARY screen.

Figure 20 Viewing a User saved ECoG

Captured ECoGs reside in the RNS® Neurostimulator memory until they are transferred to the programmer at the next inter r ogation with the wand, and are then cleared from memory. If neurostimulator memory capacity is reached, captured ECoGs are overwritten by subsequent ECoGs. The number of ECoGs that can be stored depends on the duration of each ECoG, which you can specify in the C

APTURE WINDOW field in the DURATION area on the far upper right side of the ECOG CAPTURE

screen. See Selecting ECoG Capture Settings on page 38 for details.

LIVE ECOGS SCREEN

Note: You can access the LIVE ECOGS screen only after interrogation of the neurostimulator, and the wand must be held within approximately 1 inch of the neurostimulator to acquire live ECoGs.

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After interrogation, keep the wand in place and select LIVE ECOGS from the HOME screen to open the L

IVE ECOGS screen. An ECoG is live when you open it. Buttons provide various options for viewing the

live ECoG. Select S you stop and store it until you start another live ECoG. Captured live ECoGs are stored in the EC

LIBRARY and classified as User saved.

TOP/STORE to save the ECoG in the patient’s ECoG library. It remains on screen after

Figure 21 Live ECoGs screen

Live ECoG capture can be useful for immediate or later analysis of patient ECoGs, for adjusting amplifier gain settings, and for simulated detection as part of Configure Pattern Detection: Define and Modify Detection Settings (see page 44).

Important Note: The recording montage must be programmed before live ECoGs can be viewed. See Create the Recording Montage on page 32.

Note: The maximum length for a live ECoG is four minutes. If the live ECoG is allowed to scroll for more than four minutes, only the last four minutes are stored.

Note: Live ECoGs are stored on the tablet, not in the neurostimulator memory, and are uploaded to the PDMS if and when the tablet is logged into the PDMS.

Caution: Telemetry Artifact

Telemetry may produce an electrographic artifact. If responsive therapy is enabled with a sensitive detection set, detection of the electrographic artifact may occur, resulting in therapy delivery. The physician should be aware of possible sensing artifacts when assessing the ECoG recordings.

CREATE THE RECORDING MONTAGE

The RNS® Neurostimulator can sense brain activity (ECoGs) from up to four amplifier channels. The programmed configuration of leads and electrodes you assign to each channel constitute the recording montage. You create the montage using the tablet. There can be only one current montage and

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corresponding detection settings. When the montage is altered, the detection settings created with the previous montage are discarded and the detection settings must be reprogrammed.

Identifying Ports, Leads and Electrodes on the Neurostimulator

The figure below identifies neurostimulator PORT #1 and PORT #2 with their leads extending out of the ports.

Figure 22 RNS® Neurostimulator port #1 and #2 locations. Port #1 is closer to the center of the neurostimulator and port #2

is closer to the edge.

For both depth leads and cortical strip leads, the electrodes are numbered 1 through 4 starting from the distal end of the lead.

Figure 23 For both lead types, electrodes are numbered 1 through 4. Electrode 1 is most distal.

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Creating the Montage

1. From the H

Note: For all settings, changed settings are indicated by blue buttons. Gray buttons indicate settings have not changed.

OME screen, select NEUROSTIM INFO. The NEUROSTIM INFO screen opens.

2. On the N

ECORDING MONTAGE screen opens.

EUROSTIM INFO screen, select CHANGE RECORDING MONTAGE at lower right. The

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Select type of lead for Port #1 and Port #2

Lead label is

editable

Measured Impedances

Channel

Rows

Figure 24 Recording Montage screen

Electrodes 1 - 4 for lead on Port #2

3. At Neurostimulator Implant and When Changing Leads – Select Lead Type: Upon first

use of leads, you must select the lead type for P field that says N

ONE, just below the PORT #1 or PORT #2 names at the top, and select the type

ORT #1 and/or PORT #2. To do this, select the

of lead installed in each port. When lead types are already selected for the ports, proceed to the next step.

4. Assign Channels: Use the channel rows and electrode columns to assign two electrodes to

each C

HANNEL (1 through 4). To do this, select the small, square field where the channel and

electrode intersect and then select a positive [+] non-inverting input, a negative [–] inverting input, or zero [0]. Detection occurs across the selected electrodes for each channel.

Each electrode can be assigned to one or two channels. The tablet requires you to use a positive [+] input for electrodes assigned to two channels.

Note: The tablet does not permit use of a negative [–] input for electrodes assigned to two channels because it may result in ECoG artifacts.

5. Set Gain: Next to the channel name on the left, select the G

select H

IGH, MEDIUM-HIGH, MEDIUM-LOW, or LOW. The default is HIGH and it is usually not

AIN field for each channel to

changed. After programming, you can assess ECoG signal amplification by viewing the live ECoGs.

6. Scheduled Impedance Settings: These settings are at lower left. By default, the tablet

schedules an impedance test on all electrodes every 7 days with 3.0 mA current at 2:00 Select the fields next to I

NTERVAL, CURRENT and TIME to choose different settings. Normally

AM.

there is no need to use other than the default settings.

Recommended Initial Montage Settings

• Channel 1 = Lead 1: Electrode 1 [+], Electrode 2 [–]

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• Channel 2 = Lead 1: Electrode 3 [+], Electrode 4 [–]

• Channel 3 = Lead 2: Electrode 1 [+], Electrode 2 [–]

• Channel 4 = Lead 2: Electrode 3 [+], Electrode 4 [–]

AIN set to HIGH for all channels (default)

• G

CHEDULED IMPEDANCE settings = Interval: 7 days, Current: 3.0 mA, Time: 2:00 AM (defaults)

• S

Figure 25 Recommended initial monta g e settings

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Program the Neurostimulator with the New Settings

The new settings are not sent to the neurostimulator until you complete this step.

Note: ECoG capture triggers are inactive during programming. Programming clears activity information and ECoGs stored in the neurostimulator. If there is any new information, be sure

to interrogate the neurostimulator prior to programming.

7. Select R

8. On the R

EVIEW & PROGRAM at upper right (Figure 25).

EVIEW screen, if you are satisfied with the new or changed settings, place the wand

within approximatel y 1 inch of the neurostimulator and select C satisfied, select C

ROGRAMMING NEUROSTIMULATOR dialog shows programming progress until complete.

The P

ANCEL to return to the previous screen.

ONFIRM PROGRAMMING. If not

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SET UP ECOG CAPTURE

Electrocorticograms (ECoGs) can be stored by the RNS® Neurostimulator when an ECoG capture trigger occurs. The maximum number of ECoGs that can be stored is affected by the number of channel(s) selected ON for storage, and the pre-trigger and post-trigger durations. The oldest stored ECoGs are continually replaced by the newly stored ECoGs, except as noted below.

The number of ECoGs stored for a particular ECoG capture trigger can be reserved. Reserved ECoGs are only overwritten by newer ECoGs of the same ECoG capture trigger type.

ECoG capture may also be scheduled at four different times on a 24-hour clock.

Selecting ECoG Capture Settings

1. Select NEUROSTIM SETTINGS from the HOME screen.

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2. On the NEUROSTIM SETTINGS screen, select ECOG CAPTURE at upper right. The ECOG

CAPTURE screen opens.

Figure 26 ECoG Capture screen, left side. Swipe left to see right side.

Figure 27 Right side of ECoG Capture screen

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3. Turn On Desired Channels: In the CONFIGURE CHANNELS area at lower right, select the

N/OFF switch next to the desired CHANNEL(S) (CH 1 through CH 4) to turn each channel on

or off as desired. Only the channels selected O

N will be recorded and stored.

4. Set Capture Duration: In the D

APTURE WINDOW field and select one of the capture duration options. After your selection,

the D

URATION area sho ws t he total duration (in seconds) and the number of ECoGs that can

URATION area at upper right (Figure 27 above), select the

be stored at this duration.

5. Set Capture Triggers: In the T

below), select the O

N/OFF switch to turn ON the triggers that you wish to initiate ECoG

RIGGERS area at upper left (Figure 26 above and Figure 28

capture.

Figure 28 Selecting ECoG Capture Triggers

There are three recommended ECoG triggers to be programmed at implant. The first is a magnet swipe by the patient, which could indicate that a clinical seizure has occurred. The others are saturation (high amplitude ECoG) and long episode (sustained changes in the ECoG), both of which could indicate an electrographic seizure.

Commonly Used Triggers: The more commonly used triggers are listed first.

CHEDULED STORAGE: Initiate ECoG capture at up to four specific start times, which you

• S can select using the fields to the right. Options are available in ten minute intervals using 24 hour time.

• M

AGNET: Initiates ECoG capture when the patient swipes the magnet over the

neurostimulator. If the patient swipes the magnet when they experience clinical symptoms, selecting this trigger may be helpful in evaluating these events.

• L

ONG EPISODE: Initiates ECoG capture when a detected episode exceeds the duration

you select in the L

ONG EPISODE LENGTH field to the right. Duration options range from 1 to

120 seconds.

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• SATURATION: Initiates ECoG capture when the ECoG amplitude exceeds the threshold associated with the value you select in the S sensitivity options are High, Medium, Low and Off. Selecting this trigger may be helpful in troubleshooting the RNS

System.

ATURATION SENSITIVITY field to the right. The

Additional Triggers: Select the down arrow next to

ADDITIONAL TRIGGERS at lower left to

access the triggers below.

ESPONSIVE THERAPY: Initiates ECoG capture when electrical stimulation therapy is

• R delivered in response to a detected eve nt. Selecting this trigger may be helpful in determining if therapy was delivered appropriately as well as evaluating the result of therapy delivered.

• P

ATTERN A DETECTION and PATTERN B DETECTION: These are separate triggers; each

initiates ECoG capture when a detected episode begins with the patterns designated as Pattern A and Pattern B on the P

ATTERN DETECTION screen. Selecting a pattern trigger

may be helpful in evaluating the pattern detection settings.

OST-EPISODE: Initiates ECoG capture at the end of a detected episode. Selecting this

• P trigger may be helpful in evaluating activity after an episode.

OISE: Initiates ECoG capture when the ECoG signal exceeds 60 Hz. Selecting this

• N trigger may be helpful in troubleshooting the RNS

ATURATION IN LONG EPISODE: Initiates ECoG capture when the ECoG amplitude exceeds

• S the threshold selected in the S exceeds the duration selected in the L

ATURATION SENSITIVITY field during an episode that

ONG EPISODE LENGTH field.

6. Set Reservations for Each Trigger: In the R

ESERVE SPACE column to the right of each

System.

trigger (see Figure 28 above), select the reservations field and select the number of reservations to make for each trigger. A reservation means that up to the specified number of ECoGs will be stored for that trigger, and can only be overwritten by newer ECoGs of the same trigger type. The total number of reservations available depends on the duration selected in the D

URATION area at upper right.

Recommended Initial ECoG Capture Settings

• Configure Channels for Capturing: All four channels ON

• Duration: 90

SECS

• Triggers On for ECoG Capture:

ONG EPISODE: Reservations = 2, Long Episode Length = 30 SECS

• L

AGNET: Reservations = 1

• M

ATURATION: Sat ur ati on Se nsiti vi t y: LOW, Reservations = 1

• S

• All other triggers OFF

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Figure 29 ECoG Capture showing recommended initial settings

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Program the Neurostimulator with the New Settings

The new settings are not sent to the neurostimulator until you complete this step.

Note: ECoG capture triggers are inactive during programming. Programming clears activity information and ECoGs stored in the neurostimulator. If there is any new information, be sure

to interrogate the neurostimulator prior to programming.

7. Select R

EVIEW & PROGRAM at upper right. The REVIEW screen opens. It lists all changes you

are about to program.

8. On the R

EVIEW screen, if you are satisfied with the new or changed settings, place the wand

within approximatel y 1 inch of the neurostimulator and select C satisfied, select C

ANCEL to return to the previous screen.

ONFIRM PROGRAMMING. If not

ROGRAMMING NEUROSTIMULATOR dialog shows programming progress until complete.

The P

RECOMMENDATION FOR REVIEW OF INITIAL ECOG CAPTURE SETTINGS

ECoGs stored by the RNS® Neurostimulator during the first several days after implantation of the neurostimulator and leads may not be representative of the patient’s typical baseline activity. ECoG capture settings should be reviewed to ensure that the desired activity is being stored. If it appears that ECoGs containing the desired activity are being overwritten by later events, instruct the patient to use the remote monitor and wand to interrogate the neurostimulator immediately after each clinical seizure, or to interrogate several times per day. Several interrogations per day during the first several days after implantation will not have a signif icant impac t on batter y life.

• Recommendation: Review ECoGs on the PDMS to determine whether detections and storage are optimal. If not, consider adjustments to the following triggers recommended to be O

ONG EPISODE LENGTH: Adjust the duration that triggers capture of a long episode.

• L

AGNET: Consider turning OFF the MAGNET trigger if the patient is not able to apply the

• M

magnet before or immediately after a clinical seizure, or if ECoGs capt ured b y thi s trigger ar e not useful. Magnet swipes will still be counted and reported in the diagnostics.

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• DURATION: Select a briefer CAPTURE WINDOW value to yield more stored ECoGs, or a

engthier value to yield fewer stored ECoGs.

If you make changes, be sure to follow the steps above to review and program the new settings into the neurostimulator.

CONFIGURE PATTERN DETECTION: DEFINE AND MODIFY DETECTION SETTINGS

Pattern detection settings are used by the RNS® Neurostimulator to recognize epileptiform activity as defined by the physician. To configure pattern detection means to select specific ECoG patterns to be detected, and then to program the system to detect these patterns. Configuring pattern detection is a prerequisite for electrical stimulation therapy, but it does not require you to enable therapy.

Note: A pattern defines the type of ECoG activity to be detected. Note: When defining or modifying a detection set, the programmer and the PDMS are able to

automatically simulate detection on all ECoGs stored for a patient. Simulation is displayed for groups of six ECoGs at a time, with the user able to navigate through all ECoGs for that patient.

Note: Although detection sets can be created and modified using the PDMS either in a web browser or on the programmer, only the programmer can be used to program the new settings into the neurostimulator. When you select a new detection set that was created on the PD MS , it is not necessary to re-run simulation on the programmer.

Configuring pattern detection has three phases:

• Phase 1: Select a Default Detection Set upon First Use on page 45, you select one of the three default detection sets to gather an initial collection of ECoGs. This is usually configured and programmed in the operating room immediately after implantation.

• Phase 2: Define a Pattern Detection Set on page 48, after initial ECoGs have been stored, you review the stored ECoGs and identify the specific ECoG patterns to be detected. Using the SimpleStart Feature, the system provides a s as you exercise clinical judgment to define detection settings. It suggests a starting point only. It does not preempt nor replace your clinical judgment. This is usually programmed at the first visit post-implantation.

• Phase 3: Customize Pattern Detection on page 52, you repeat the process of reviewing stored ECoGs and adjusting the parameters of each pattern to optimize detection of ECoG activity for this patient. This is programmed at any visit after phase 2.

Note: For all settings, changed settings are indicated by blue buttons. Gray buttons indicate settings have not changed.

o put these three phases in context:

Immediately after implantation of the neurostimulator, you select a default detection set in Phase 1, in order to collect ECoGs with activity of interest specific to the patient, and ECoGs with baseline activity.

After collecting sufficient ECoGs, you identify the specific electrocorticographic patterns to be detected and then, in Phase 2, the system provides a starting point for establishing a patient-specific detection set. You may then modify the parameters of the suggested starting detection set to make detection more or less sensitive, or to detect earlier or later.

tarting point for this process. It is a tool to assist you

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In future visits, after collecting additional ECoGs, you then, in Phase 3, iterate to improve detection (and, once responsive therapy has been enabled, to improve clinical response) by making small, incremental changes to detection parameters with the sliders or M

Note: Typically, physicians repeat earlier phases (Phase 1 or Phase 2) only if they observe a new type of ECoG activity of interest that requires an additional detector; or if a good clinical response has not been obtained and they wish to start over.

Phase 1: Select a Default Detection Set upon First U se

Upon first use of the tablet for each patient, the patient has no saved ECoGs from which to select a pattern for detection, and so you must select one of three default detection sets. This is usually configured in the operating room immediately after implantation. T he def ault sets are used to gather an initial set of ECoGs for a patient, which you can then use in a subsequent visit to define a pattern detection set specific to the patient. If you have already performed these steps once, proceed to the next section, Phase 2: Define a Pattern Detection Set.

ORE CONTROLS.

1. Select N

EUROSTIM SETTINGS from the HOME screen.

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2. On the NEUROSTIM SETTINGS screen, select PATTERN DETECTION at upper center. A list of

three C

3. Select one of the three default detection settings. In the usual case, a patient has two active

leads to be configured, and therefore the recommended default pattern is P 75% ON CH 1 & 3 (DEFAULT), the second item in the list. (If only one lead is implanted, this two-channel option will not appear in the list.) The other default patterns detect on only one lead.

• Power change 75% is a detection setting that captures any large changes in the signal

OMPATIBLE DETECTION SETS appears.

OWER CHANGE

that clinicians can program and optimize as detection patterns.

4. Select L

screen. The R

5. On the R

OAD SETTINGS at lower right, then REVIEW & PROGRAM at upper right on the next

EVIEW screen opens.

EVIEW screen, make sure DETECTION is ENABLED. Then, if you are satisfied with the

new settings, place the wand within approximately 1 inch of the neurostimulator and select

ONFIRM PROGRAMMING. If not satisfied, select CANCEL to return to the previous screen.

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When you confirm programming, a TELEMETRY INFORMATION dialog reports that “Detection is Enabled and Responsive Therapy is disabled,” and prompts you to select C

Figure 30 Telemetry Information dialog to confirm programming again

ONTINUE or CANCEL.

6. Make sure the message reports that DETECTION is ENABLED, keep the wand in place and

select C

ONTINUE to proceed with programming, or CANCEL to cancel programming and return

to the previous screen.

When you select C

ONTINUE, the PROGRAMMING NEUROSTIMULATOR dialog shows programming

progress.

Figure 31 Programming neurostimulator dialog shows progress of programming

When complete, you return to the list of COMPATIBLE DETECTION SETS. Initial configuration is complete. (You can select a different default setting and redo initial configuration if desired.)

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Phase 2: Define a Pattern Detection Set

Note: You must be connected to the PDMS (via the Internet) to define a pattern detection set. If not, you can program only a default detection set or a detection set previously defined and downloaded to the tablet. If you are not connected to the Internet, see Connect to the Internet for PDMS Access on page 10.

At this point, the patient should have ECoGs stored in the PDM S from which to select specific patterns for detection. A set of patterns you define and name is called a pattern detection set (or simply a detection set). A pattern defines the type of ECoG activity to be detected. You can define up to four patterns in a set, two patterns on each of two channels. The patterns defined on a specific channel can operate only in that selected ECoG channel. Follow these steps to define a pattern detection set.

1. Select N

2. On the N

ATTERN DETECTION screen opens.

EUROSTIM SETTINGS from the HOME screen,

EUROSTIM SETTINGS screen, select PATTERN DETECTION at upper center. The

Figure 32 Pattern Detection screen

• The NAME field at upper left identifies the currently active detection set, as indicated by

(

ACTIVE) next to the field. You can edit this set or select an inactive set to program by

selecting the N

AME field.

• The upper half of the screen provides tiles to select the current detection patterns and

channels; the tiles are named P

ATTERNS A1 & B1 (upper left) and PATTERNS A2 & B2 (upper

right).

• The lower half of the screen shows thumbnails of all ECoGs (if no filters are on) stored in the

PDMS that were captured using the current recording montage. (ECoGs stored in the PDMS were uploaded after interrogations from the remote monitor or programmer.) You can filter

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the ECoGs shown using the TRIGGERS and CATEGORIES menus at left center, and/or by date range using the F

ROM and TO fields at middle right.

• The S

IMULATE button at upper right (next to ADVANCED) is switched ON (blue) by default,

which enables simulations of detections to be shown on all ECoGs shown on this screen.

3. To define or change a detection set, select the desired detection set in the N

AME field at

upper left.

• The detection set may be one of the three default detection sets to be used as a starting point

for configuration; or it may be a detection set created and saved previously.

• If you don’t want to modify the detection set you chose, you can program the detection set

right away: Select R approximately 1 inch of the neurostimulator, follow the prompted steps to C

EVIEW & PROGRAM at upper right and, while holding the wand with in

ONFIRM

PROGRAMMING and CONTINUE sending the new settings to the neurostimulator.

4. Use the D

the D

• Select one of the two P

EFINE PATTERNS dialog to define or modify a detection set. There are two routes to

EFINE PATTERNS dialog.

ATTERN tiles at the top to go there directly, or

• Select one of the ECoG thumbnails at the bottom to open its ECoG dialog, which is named by

its date and trigger type, and then select one of the two M

ODIFY buttons (A1 & A2, B1 & B2)

at upper right. (You can also use the ECoG dialog to assign the ECoG to a category if desired.)

If You Selected a New ECoG First

5. If you selected a new ECoG first and selected a MODIFY button, a SELECT CHANNEL dialog

opens. Touch within the channel that has a pattern to detect. Then the D

EFINE PATTERNS

dialog opens.

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Using the Define Patterns Dialog

Note: A pattern defines the type of ECoG activity to be detected.

6. In the D

EFINE PATTERNS dialog, the upper portion shows the ECoG in the selected channel.

Touch on the point of the ECoG where you would like detection to occur. Starting from the point where you touch, a 3-second window of time (or region of i nterest, ROI) is bracketed on the ECoG. This touch feature to bracket a 3-second region of interest is called the SimpleStart Feature.

Figure 33 Define Patterns dialog

• The 3-second window bracketed on the ECoG is the patter n you are identifying for detection; it should contain the type of pattern you would like to detect.

• Each 3-second window is identified as one of the four possible patterns you can define A1, A2, B1 or

and B patterns are defined on different leads.)

B2. (The 1 and 2 indicate the first and second ROI you select. Typically th

• You can touch on the window identifier (A1, A2, B1 or B2) and slide the window left or right to place it where it gives the desired simulated detection results. Note that th s

oftware may apply a different suggested detection tool when you move the window.

Note: You cannot select a 3-second window within the first 5 seconds of an ECOG, bec aus e the software looks for differences in the ECOG data before the 3-second window and needs sufficient preceding data to determine this difference. If you touch before 5 seconds in the ECoG, the software places the window starting at the 5-second mark.

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• Normally you want to touch near the beginning of the pattern in order to define a pattern that will be detected promptly after it begins. Detection settings should promptly detect ECoG activity and not detect on baseline activity.

The software automatically applies a suggested detector (shown in the D

ETECT field) and

settings that fit the waveform pattern in that 3-second window (or region of interest, ROI), and simulates detection, showing the detection flags the chosen pattern would apply to this ECoG—and to all the patient’s other stored ECoGs shown in smaller size below. It is recommended to review simulated detection activity on an ensemble of stored ECoGs before finalizing the detection setti ngs .

• To hide the simulation on the ECoG, select H select C

LEAR.

IDE. To remove the selection on the ECoG,

• At any point, you can select a different ECoG by selecting an ECoG thumbnail along the bottom; swipe left or right to view all available thumbnails.

• By default, if you define both patterns, detections will occur for both patterns on this channel. The channel is indicated by the filled oval at top center of the dialog, from 1 to 4 top to bottom. Use the C

HANGE CHANNEL button to change the channel on which to detect the

pattern.

Note: If simulating performance of a 2-channel detection set, be sure to select ECoGs that contain ECoG activity patterns you wish to detect in both channels.

• Make adjustments to the parameters applicable to the detection tool using the sliders available and observe the effects on the simulation. For S

PIKE ACTIVITY and RHYTHMIC

ACTIVITY, the sliders adjust AMPLITUDE (%) and DURATION (seconds). For POWER CHANGE, the sliders adjust S

ENSITIVITY (%) and DETECT (seconds).

• All these detection parameters affect sensitivity. Adjustments that increase sensitivity

tend to increase how early and how often the pattern i s detecte d; adj ustments that decrease sensitivity tend to decrease how early and how often the pattern is detected.

• Detection settings should be programmed for early detection of activity. Detection

settings that result in early activity detection usually also result in numerous detections; this is expected and acceptable behavior.

• The parameter values are shown to the right of each slider. For all four parameters, lower

values result in greater sensitivity.

• The M

ORE CONTROLS button gives access to additional adjustment options and Advanced

Controls (see page 63).

7. Select D

ONE at upper right to close the DEFINE PATTERNS dialog. The detection set is not

saved until you save it in the next step.

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Figure 34 Detection settings ready to be saved

Note: ECoG capture triggers are inactive during programming. Programming clears activity information and ECoGs stored in the neurostimulator. If there is any new information, be sure

to interrogate the neurostimulator prior to programming.

8. Save and Program: Back in the N name the detection set in the S

EVIEW & PROGRAM at upper right and, while holding the wand within approximately 1 inch of

the neurostimulator, follow the prompted steps to C

EUROSTIM SETTINGS screen, select SAVE at upper center;

AVE DETECTION SET dialog and select SAVE; then select

ONFIRM PROGRAMMING and CONTINUE

sending the new settings to the neurostimulator.

Phase 3: Customize Pattern Detection

To customize pattern detection is to refine detection settings to promptly detect the specific patterns for this patient, and not detect on baseline activity, since detection serves as the basis for neurostimulator treatment. On visits subsequent to Phase 2: Define a Pattern Detection Set, the usual, systematic approach is to make small, incremental adjustments to individual parameters of a detection pattern. The adjustment you make may be intended to increase or decrease how early and how often the pattern is detected, based on your assessment of current detection activity as viewed on stored ECoGs and on the Activity Screen (see page 23).

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1. Select NEUROSTIM SETTINGS from the HOME screen,

2. On the N

ATTERN DETECTION screen opens.

Figure 35 Pattern Detection screen

EUROSTIM SETTINGS screen, select PATTERN DETECTION at upper center. The

• The NAME field at upper left identifies the currently active detection set, as indicated by (

ACTIVE) next to the field. You can edit this set or select an inactive set to program by

selecting the N

AME field.

Note: To customize the current pattern detection set, do not change the active detection set shown by default in the N

AME field at upper left.

• The upper half of the screen provides tiles to select the current detection patterns and channels; the tiles are named P

ATTERNS A1 & B1 (upper left) and PATTERNS A2 & B2 (upper

right).

• The lower half of the screen shows thumbnails of all ECoGs (if no filters are on) stored in the PDMS that were captur ed using the cur re nt rec ord ing montage. You can filter the ECoGs shown using the T

• The S

IMULATE button at upper right (next to ADVANCED) is switched ON (blue) by default,

RIGGERS and CATEGORIES menus at left center.

which enables simulations of detections to be shown on all ECoGs shown on this screen.

3. Select one of the two P

ATTERN tiles at the top to access the DEFINE PATTERNS dialog.

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Figure 36 Define Patterns dialog

4. In the DEFINE PATTERNS dialog, select and adjust the desired parameter using the sliders so as to increase or decrease how early and how often the pattern is detected.

The software automatically simulates detection with the changed parameter as applied to this ECoG and to the patient’s other stored ECoGs shown in smaller size below. It is recommended to review simulated detection activity on an ensemble of stored ECoGs before finalizing your adjustment.

• Swipe up to view the bottom of the dialog where the ECoGs appear with simulated detection; swipe left or right to see more ECoGs if available. You can filter the ECoGs using the T

RIGGERS and CATEGORIES menus, and/or the FROM and TO date range

fields.

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Figure 37 Detection simulation in all ECoGs

• To hide the simulation on the ECoG, select HIDE. To remove the pattern on the ECoG, select

LEAR.

• Detection parameters that affect sensitivity are key: adjustments that increase sensitivity tend to increase how early and how often the pattern is detected; adjustments that decrease sensitivity tend to decrease how early and how often the pattern is detected.

• To adjust sensitivity, the two most common parameters to adjust are the ones with sliders directly on the D sliders adjust A

ENSITIVITY (%) and DETECT (seconds).

EFINE PATTERNS dialog. For SPIKE ACTIVITY and RHYTHMIC ACTIVITY, the

MPLITUDE (%) and DURATION (seconds). For POWER CHANGE, the sliders adjust

Note: The parameter values are shown to the right of each slider. For all four parameters, lower values result in greater sensitivity. Make adjustments and observe the effects on the simulation.

• The M

ORE CONTROLS button gives access to additional adjustment options and advanced

settings.

5. Select D

ONE at upper right to close the DEFINE PATTERNS dialog. The detection set is not

saved until you save it in the next step.

6. Save and Program: Back in the N rename the updated detection set if desired in the S

AVE. Then select REVIEW & PROGRAM at upper right and, while holding the w and with in

approximately 1 inch of the neurostimulator, follow the prompted steps to C PROGRAMMING and CONTINUE sending the new settings to the neurostimulator.

EUROSTIM SETTINGS screen, select SAVE at upper center;

AVE DETECTION SET dialog, and select

ONFIRM

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• After changing detection settings, the NEUROSTIM SETTINGS screen has a REVERT button next to the S

AVE button. Select REVERT if you want to remove all changes to the detection settings

and revert to the current detection set.

DETECTION TOOLS AND DETECTORS

Note: Detection tools and detectors support you as you exercise clinical judgment to define detection settings. Detectors and settings initially suggested by the software (as des cr ibed in Phase 2 on page 48) offer a starting point only. The software does not preempt nor replace your clinical judgm e nt.

In previous versions of programmer software, the physician selected a set of ECoGs with specific patterns to be detected, chose a detection tool and settings, observed the simulated detections that would occur on that set of ECoGs, and then repeated the proc

In the current version, when you use the SimpleStart Feature to select a waveform pattern to detect, the software suggests a detector (one of POWER CHANGE, RHYTHMIC ACTIVITY or SPIKE ACTIVITY) and associated settings as a proposed fit for that pattern. You use this procedure initially (in Phase 2: Define a Pattern Detection Set, see page 48) to create a new detection set when you have first gathered ECoGs containing the type of activity you wish to detect. This detection set is a suggested starting point to assist you as you exercise clinical judgment to define detection settings. It suggests a starting point only. It does not preempt nor replace your clinical judgment. The software also simulates the suggested detector and settings on all of the patient’s stored ECoGs. By reviewing the simulated detection on an ensemble of stored ECoGs, you can confirm that detection occurs when desired, or c hange the selected pattern, detectors and/or s ettings to make detection occur when desired. Having defined up to four detection patterns and associated settings, you then save them as a detection set. (Up to four detection patterns on up to two channels comprise a detection set.)

ess iteratively to define a detection set.

Detection Tools and Detectors

The RNS® Tablet uses three kinds of detection tools: POWER CHANGE (page 57), BANDPASS (page

61), and A

REA (page 62).

• The P

OWER CHANGE detection tool (formerly line length) is used in the POWER CHANGE

detector.

• The B

ANDPASS detection tool is used in two detectors, RHYTHMIC ACTIVITY and SPIKE

ACTIVITY.

REA detection tool is infrequently used and can be selected only manually from the

he A

• T

EFINE PATTERNS dialog (select MORE CONTROLS > ADV CONTROLS).

Note: R detected by the B an ROI, but can be manually programmed by selecting M

HYTHMIC ACTIVITY and SPIKE ACTIVITY both are types of ECoG activity that can be

ANDPASS tool. The AREA too l is not us ed to gener ate a suggested detector from

ORE CONTROLS > ADV CONTROLS.

The table below summarizes this information.

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Detection Tool

Detectors Used With

)

BANDPASS

Rhythmic Activity and Spike Activity

suggested detector)

POWER CHANGE

(FORMERLY LINE

ENGTH

Power Change

AREA

Area (configured manuall y onl y, not used as a

Power Change Detector

To understand how the power change detector works refer to Figure 39. Imagine the ECoG as a string that can be stretched so the length can be measured. ECoGs w ith higher amplitude or frequency oscillations will have longer length.

Figure 38 An illustration of the Power Change dete ct or

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The ECoG in the bottom of Figure 39 below shows a developing seizure that corresponds in time with the short-term power change trend line (red) and the long-term power change trend line (blue). The power change detector works by comparing the normalized ECoG length (length per second) in a short-term trend window (typically 1 to 4 seconds, red line in graph) to the normalized ECoG length in a long-term trend window (typically 1 to 2 minutes, blue line in graph).

Figure 39 Power Change detector example

Detection occurs when the difference between the short-term and long-term trend windows exceeds a programmed S earlier and more frequent detections. The D (in seconds). Shorter D

ENSITIVITY percentage (typically 37.5% to 100%). Lower SENSITIVITY settings result in

ETECT setting specifies the length of the short-term trend

ETECT sett in gs res ult in earl ier and m or e frequent detec t io ns .

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Rhythmic Activity Detector

The Rhythmic Activity detector provides highly specific and early detection of rhythmic activity within a defined bandwidth. It acts like a frequency filter and can therefore be used to detect activity within specific frequency bands (theta, alpha, beta, and gamma). To understand how the Rhythmic Activity detector works refer to Figure 40.

Figure 40 Rhythmic Activity detector example

The Rhythmic Activity detector analyzes t he ECoG to deter mine when a signal is present within a specified bandwidth that meets specified amplitude and duration requirements. Four configurable parameters define the Rhythmic Activity detector operation: the M

INIMUM FREQUENCY and MAXIMUM

FREQUENCY that define the bandpass, the AMPLITUDE, and the DURATION. Detection occurs when a signal within the bandwidth exceeds the A

MPLITUDE for the minimum DURATION. As DURATION is

increased, the detector becomes less sensitive because it will take longer for a signal at a given frequency to be detected. As D it will take less time for a signal at a given frequency to be detected. As A detector becomes less sensitive because lower amplitude signals will be rejected. As A

URATION is decreased, the detector becomes more sensitive because

MPLITUDE is increased, the

MPLITUDE is

decreased, the detector becomes more sensitive because lower amplitude signals will be accepted.

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Spike Activity Detector

The Spike Activity detector functions in a manner very similar to the Rhythmic Activity detector, but it is optimized for the faster transients that comprise spikes. To understand how the Spike Activity detector works refer to Figure 41.

Figure 41 Spike Activity detector example

The Spike Activity detector analyzes the ECoG to determine when a signal is present within a specified bandwidth that meets specified amplitude and duration requirements. Four configurable parameters define the Spike Activity detector operation: the M

INIMUM FREQUENCY and MAXIMUM

FREQUENCY, the AMPLITUDE, and the DURATION. The MINIMUM FREQUENCY defines the slowest spiking rate that can be detected. The M

AXIMUM FREQUENCY defines the upper passband for the detector.

Because the signal frequency content of the fast transient portions of spikes are generally much higher than the spike rate, the M

AXIMUM FREQUENCY usually needs to be set much higher than the

spike rate. Detection will occur when spikes meeting the frequency requirements also exceed the

MPLITUDE for the DURATION. As DURATION is increased, the detector becomes less sensitive

because it will take longer for detection to occur. As D

URATION is decreased, the detec tor becomes

more sensitive because it will take less time for a detection to occur.

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Bandpass Detection Tool

The Bandpass detection tool provides highly specific and early detection of rhythmic and spiking activity. It acts like a frequency filter and can therefore be used to detect activity within specific frequency bands (for example, theta, alpha, beta, and gamma). The R

ACTIVITY detectors use the Bandpass tool.

HYTHMIC ACTIVITY and SPIKE

Figure 42 Bandpass detection tool example.

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Area Detection Tool The AREA detection tool can be selected only manually from the DEFINE PATTERNS dialog (select

ORE CONTROLS > ADV CONTROLS). It is not used as a suggested detector by the software. The AREA

detection tool measures the area between the ECoG and the time axis (see Figure 43).

Figure 43 Area detection tool example

The Area detector operates by comparing the normalized ECoG area (area per second) in a shortterm trend window (typically 1 to 4 seconds) to the norm alized ECoG area in a long-term trend window (typically 1 to 2 minutes). Detection occurs when the difference between the short-term and long-term trend windows exceeds a programmed threshold (typically 37.5% to 100%).

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Advanced Controls The physician has access to advanced controls from the DEFINE PATTERNS dialog. Select MORE

CONTROLS > ADV CONTROLS to open the ADVANCED SETTINGS dialog for the pattern you are currently

defining, which gives access to additional settings for the detection tools B and A

REA. (AREA can be selected only in this dialog.) Select the down-arrow next to TECHNICAL

PARAMETERS to access even more settings. You can select more than one tool for use at the same

time in this dialog.

ANDPASS, POWER CHANGE

Figure 44 Bandpass, Power Change and Area settings, in Advanced Settings dialog

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SHARE AND/OR DOWNLOAD A DETECTION SET

This section explains how to share a detection set with the users or programmers you select, and how to download a shared detection set. For example, use this feature when more than one physician is treating a patient.

You must be connected to the PDMS (via the tablet or a web browser on a personal computer) to define or modify a custom detection set, and by default, these are saved to the PDMS only—n ot loc al ly. If you are connected to the PDMS during programming, you can program the neurostimulator with any detection set saved under the current username or saved to the programmer you are using. However, if you are not connected to the PDMS (offline) during programming, you can program only the pre-programmed default detection sets or those detection sets previously downloaded from the PDMS to the programmer.

Steps to Share a Detection Set

1. Whenever connected to the PDMS, either on a programmer or using a web browser on a personal computer, you can share the currently selected detection set by selecting the S button on the N

EUROSTIM SETTINGS > PATTERN DETECTION screen. The SHARE DETECTION SET

dialog opens.

HARE

Figure 45 The SHARE DETECTION SET dialog

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2. You can select to share with:

a. A specific user, who could then access it on any programmer to which he is logged in.

Touch the S (Available usernames would include those users who have been logged in to a programmer while interrogating the neurostimulator associated with the patient to which the detection set applies.)

b. All known programmers, which means any programmer that has interrogated the

neurostimulator associated with the patient to which the detection set applies

c. One specific programmer, which you must identify by its serial number. The serial

number is on the label affixed to the back of the programmer.

HARE WITH USER field to select from a list of available usernames, if any.

3. When you have selected a user or programmer(s) to share with, select the S S

HARE DETECTION SET dialog. A message appears to tell you that the detection set was saved

HARE button in the

and will be sent to the indicated user and/or programmer(s) the next time they are synchronized with the PDMS.

Figure 46 Example message reporting successful sharing

What Happens to a Shared Detection Set Sharing a detection set using the foregoing method merely makes it available to the targeted user or

programmer when connected to the PDMS. Shared detection sets are not automatically downloaded and saved locally to the programmer.

What happens is that the next time the targeted user or programmer connects to the PDMS, an icon with two wavy red lines will appear on the N

EUROSTIM INFO dialog opens, where the alert icon is shown again with the text "A pending

EUROSTIM INFO tile. When they select the icon, a

Detection Set is available on PDMS. Cli ck the icon to being loading it." When the user clicks this

icon, an overlay appears that describes the detection set: the name, the time it was created, and the name of the person who shared it. They can A

ATTERN DETECTION screen and automatically load the detection set, or they can SKIP the detection

CCEPT the detection set, which will bring the user to the

set, which clears the alert and allows the user to continue with their session. Whether accepted or skipped, the detection set will still be av ailab le in the lis t of detecti on sets in N

EUROSTIM SETTINGS—as

long as the programmer is connected to the PDMS. However, whether you accept or skip the detection set, the programmer does not download the detection set to the programmer for offline use. There is only one way to download a detection set to the programmer for offline use, described next.

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Steps to Download a Detection Set to the Tablet

To download a detection set and save it locally to the tablet for offline use, follow these steps:

Figure 47 Start screen

1. Select the PATIENT LIST tile on the tablet Start screen. The patient list opens.

2. Select a patient from the patient list. The P the tablet H

OME screen (shown in Figure 6 on pag e 18).

ATIENT HOME screen opens. Note this is different than

Figure 48 Patient Home screen

3. Select the Neurostim Settings tile. The NEUROSTIM SETTINGS > PATTER DETECTION screen opens.

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Figure 49 Pattern Detection screen

4. Select the NAME field and select the name of detection set you want to download to the tablet.

5. Select the S

HARE button. The SHARE DETECTION SET dialog opens, but in this case, it includes a

checkbox named “Download to this Programmer now” along with the other sharing options.

Figure 50 The SHARE DETECTION SET dialog with download now option

6. Select the “Download to this Programmer now” checkbox.

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Figure 51 The SHARE DETECTION SET dialog with download now option selected

7. Select the SHARE button. A download progress dialog appears briefly, and when download is complete, a PDMS Transfer message reports “The detection set download has completed

successfully and will be available in offline mode.”

Figure 52 PDMS TRANSFER message reports a successful detection set download

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OVERVIEW OF RESPONSIVE THERAPY

The RNS® Neurostimulator can deliver a therapy sequence of up to 5 individually configured therapies in response to detected activity. The neurostimulator resumes sensing after each therapy is delivered. If the activity is still detected, the next (sequential) therapy is delivered. If the activity is no longer detected, the remaining therapies are not delivered and the episode ends. Therapy sequence refreshes with the detection of each new episode.

The system enables you to configure behavior for the first therapy in therapy sequence in one of two ways:

• You can select different bursts to be delivered in response to a specific event detector (Pattern A or Pattern B), as depicted in Figure 53; or

• You can select up to two bursts to be delivered in response to any event det ect o r, as depicted in Figure 54.

All subsequent therapies deliver a maximum of 2 bursts and are independent of the event detector.

Figure 53 A THERAPY SEQUENCE DELIVERED IN RESPONSE TO A SPECIFIC EVENT DETECTOR

Therapy 1 is configured to deliver a single burst in response to a specific detector. In this example, Pattern A is detected at the episode start; Therapy Pattern A burst is delivered. If Pattern B is detected at the episode start, Therapy Pattern B burst is delivered. Subsequent therapies, Therapy 2 and Therapy 3, are configured to deliver 2 bursts each, no matter which pattern is subsequently detected.

Figure 54 A THERAPY SEQUENCE DELIVERED IN RESPONSE TO ANY EVENT DETECTOR

Therapy 1 is configured to deliver Burst 1 and Burst 2 in response to any event detector. In subsequent therapies, Therapy 2 is configured to deliver Burst 1 only and Therapy 3 is configured to deliver Burst 1 and Burst 2.

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The following figure identifies the parameters of a burst of stimulation therapy.

Figure 55 Parameters of a single burst of stimulation

CONFIGURE RESPONSIVE THERAPY

Detection must be enabled before responsive therapy can be enabled. Before programming responsive therapy, at least one detector must be defined in a detection set. (If you select therapy specific to a detection pattern, at least one detector must be defined for each pattern.) To set up a therapy sequence, determine the number of therapies desired for delivery in response to an episode. Select each therapy and configure each burst, which is a collection of one to many biphasic pulses.

Note: For all settings, changed settings are indicated by blue buttons, with the new setting above and the old setting below. Gray buttons indicate settings have not changed.

Note: It is recommended to review and perform detection analysis prior to enabling responsive therapy.

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1. Select N

EUROSTIM SETTINGS from the HOME screen.

2. Select S

TIMULATION at upper center of the NEUROSTIM SETTINGS screen. The STIMULATION

screen opens. (Swipe left to see the right side.)

Figure 56 Stimulation screen, left side. Swipe left to see right side.

The screen has rows STIM 1 through STIM 5 to program up to five stimulation therapies. Each therapy is either configured or disabled. When one of the five therapies is disabled, all successive therapies are disabled also—you cannot skip a therapy. Recall that detection must be enabled before any therapy can be configured.

3. For each desired stimulation therapy and burst, starting with S

TIM 1 BURST 1, select the

electrodes on each lead across which to deliver therapy, by making at least one electrode positive [+] and another negative [–]. Note that the neurostimulator can is an optional electrode.

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only 2 channels, then the stimulation pathway should be configured such that current is delivered through only those elec tr odes w ith electrographic activity of interest.

4. Select the level of C

5. Select the PW

URRENT to be delivered dur i ng puls es .

PER PHASE, which is the pulse width or duration (in µs) of each phase of the

biphasic current pulse.

Note: The C C

URRENT and PW PER PHASE. The tablet limits the available choices for CURRENT and PW PER

ALCULATED CHARGE DENSITY reported on screen results from the combination of

PHASE to those which yield a CALCULATED CHARGE DENSITY less than 25 µC/sq cm.

6. Select the B

7. Select the F

URST DURATION, from 10 ms to 5000 ms.

REQUENCY of the biphasic current pulses, from 1 Hz to 333.3 Hz. Increasing

frequency decreases the time between each bip has ic puls e of curr ent, and vice v ers a.

8. If desired, apply the same settings to all five stimulation therapies. To do this, select the Y

button next to A

LL SETTINGS SAME AS STIM 1, near top center of the screen.

Figure 57 Stim 1 settings copied to all therapies

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Tablet Instructions 73

9. If desired, select THERAPY LIMIT PER DAY at upper right to adjust the maximum number of

episodes the neurostimulator will treat per day.

10. If desired, swipe left to access the O

PTIONS area on the right side of the NEUROSTIM SETTINGS

screen to find the following options:

Figure 58 Options on the right side of the Stimulation settings screen

a. BEHAVIOR FOR THERAPY 1: The default is EITHER DETECTION PATTERN RESULTS IN

SAME THERAPY. Select the field to select the alternate DETECTION PATTERN SPECIFIC THERAPY, to apply only Therapy 1 in response to detection of one specific pattern you

have programmed.

HERAPY LIMIT RESET TIME: Select the time of day (in 2 4-hour time) when the daily

b. T

therapy limit count resets to zero.

Skip to Test Stimulation Before Enabling on page 77 if you do not want to use the advanced settings.

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Optional Advanced Settings

If desired, select ADVANCED at far right to open the ADVANCED SETTINGS screen for the selected therapy (S

TIM row). By default, all advanced settings are disabled.

Figure 59 Stim 1 Advanced Settings

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The ADVANCED SETTINGS screen has upper, lower and bottom portions that let you select the following:

Upper portion—Adaptive Therapy: Adapts the frequency and the minimum amplitude of the stimulation therapy as a percentage of the detected signal amplitude over a chosen channel, for one or both bursts. The available options are:

Figure 60 Adaptive therapy settings—upper portion of Advanced Settings dialog

• ADAPT CHANNEL: Select one of four channels over which to enable adaptive therapy. By default, this is U

DAPT MIN AMPLITUDE: Select a percentage of the detected signal amplitude to be used

• A

NUSED, which means adaptive therapy is disabled.

as the minimum therapy amplitude.

Then for B

URST 1 and/or BURST 2, select settings for the following:

DAPTATION: Turn ON or OFF adaptive therapy for this burst.

• A

HERAPY FREQUENCY MULTIPLIER: A greater multiplier increases frequency of the burst.

• T

AX THERAPY FREQUENCY: Sets maximum frequency for this burst.

• M

IN THERAPY FREQUENCY: Sets minimum frequency for this burst.

• M

EFAULT THERAPY FREQUENCY: Sets default frequency for this burst.

• D

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Illustration: If ADAPT MIN AMPLITUDE = 100% and the detected signal frequency = 20 Hz (50

ms period), the stimulation frequency is delivered at 20 Hz (50 ms p-p interval). If

DAPT MIN AMPLITUDE = 50% and the sensed signal frequency = 20 Hz (50 ms

period), the stimulation frequency is delivered at 40 Hz (25 ms p-p interval).

If the neurostimulator cannot detect a stable frequency in the ECoG signal, or if the calculated stimulation frequency is not between the M and M

IN THERAPY FREQUENCY, then the burst is delivered at the DEFAULT THERAPY

FREQUENCY.

Lower portion—Synchronized Therapy: For BURST 1 only, synchronize delivery of therapy into

a specific part of the detected ECoG wavef orm over a chosen channel. The available options are:

AX THERAPY FREQUENCY

Figure 61 Synchronized therapy settings—lower porti on of Advanced Settings dialog

• SYNCH CHANNEL: Select one of four channels over which to deliver synchronized therapy.

YNCH MIN AMPLITUDE: Select a percentage of the detected signal amplitude to be used as

• S the minimum amplitude for synchronized therapy.

Then for B

• S

URST 1 and/or BURST 2, select settings for the following:

YNCHRONIZATION: Turn ON or OFF synchronized therapy for BURST 1. (Burst 2 is always

delivered asynchronous l y.)

ELAY: Set the delay (in ms) for delivery of BURST 1 therapy after detection of the target

• D ECoG waveform.

YNCH SLOPE: Select UP or DOWN.

• S

Note: If the neurostimulator is unable to synchronize therapy into a detected waveform, it reverts to asynchronous therapy delivery after 2 seconds.

Bottom portion—Post-Episode Interval: Select the POST-EPISODE INTERVAL, from OFF (default) to 24 HRS, to specify the time the neurostimulator waits after the end of an episode before treating a new episode. Dur ing the post-episode interval, monitoring continues but the system will not deliver therapy for a new episode.

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Tablet Instructions 77

Figure 62 Post-episode interval settings—bottom portion of Advanced Settings dialog

Save Advanced Settings: Select DONE to save the new advanced settings and return to the STIMULATION screen.

Test Stimulation Before Enabling

Before enabling responsive therapy, it is important to test stimulation to make sure it is well tolerate d by the patient and there are no undesired changes in the ECoG, such as afterdischarges.

Note: The system cannot test stimulation during a detected episode or during therapy delivery. To test stimulation, either wait for the episode or therapy to complete, or disable detection and therapy.

1. Select T stimulation settings. Note that the T

EST on the far left of the row to open the TEST STIMULATION screen and test the new

EST button is not available if adaptive therapy is on (see

Optional Advanced Settings above). An ECoG is running when the screen opens. Select

ELIVER to deliver the test burst. Select STOP/STORE when desired to stop recording.

Figure 63 Test Stimulation screen

• You can adjust settings and retest while this screen is open. To exit test stimulation, select

CCEPT CHANGES or CANCEL CHANGES at upper right.

• Stimulation may evoke visual, olfactory, auditory, taste, sensory or motor responses.

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• Test stimulations should be delivered to each electrode individually (electrode to neurostimulator) to determine whether there are acute side effects from stimulation.

• Habituation to side effects resulting from stimulation has been observed; however it is not advised to program settings that cause patient discomfort.

• Avoid stimulation settings that cause an electrographic afterdischarge.

Caution: Afterdischarge Activity

Enable Therapy: Review & Program

The new settings are not sent to the neurostimulator until you complete these steps.

1. Select R

EVIEW & PROGRAM at upper right. The REVIEW screen opens, showing a list of all

changed settings. If you are satisfied with the new or changed settings, proceed to the next step. If not satisfied, select C

Figure 64 Review screen after configuring therapy. Blue items have changed.

ANCEL at upper right to return to the previous screen.

2. To activate the configured therapy, make sure STIMULATION is set to ENABLED at u pper center.

3. On the R within approximatel y 1 inch of the neurostimulator and select C satisfied, select C

EVIEW screen, if you are satisfied with the new or changed settings, place the wand

ONFIRM PROGRAMMING. If not

ANCEL to return to the previous screen.

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Tablet Instructions 79

The PROGRAMMING NEUROSTIMULATOR dialog shows programming progress until complete.

Figure 65 Programming neurostimulator dialog shows progress of programming

Recommended Initial Responsive Therapy Settings

Responsive stimulation therapy should be enabled once the physician has determined the electrographic activity of interest is being detected.

• Program B

URRENT = 1.0 mA.

• C

URST 1 for electrodes on one lead and BURST 2 for electrodes on the other lead.

• Leave other parameters at their def ault values :

REQUENCY = 200 Hz

• F

• PW

• B

• Apply the same settings to all five stimulation therapies: select the Y

SETTINGS SAME AS

PER PHASE = 160 µs

URST DURATION = 100 ms

ES button next to ALL

STIM 1, near top center of the screen.

In general, stimulation should be delivered to the leads and electrodes from which electrographic patterns of interest are observed. For example, if electrographic activity of interest is observed on all channels, then the stimulation pathway should be configured to stimulate across all electrodes. However, if electrographic activity of interest is observed on only 2 channels, then the stimulation pathway should be configured such that current is delivered through only those electrodes with electrographic activity of interest.

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Recommended Therapy Modifications After Observing Clinical Response

Once the neurostimulator is programmed to provide responsive stimulation, the patient should be seen at approximately 3-month intervals to determine whether detection and/or responsive therapy settings should be modified. At each patient visit, the physician reviews ECoGs that are stored on the PDMS or programmer. Detection settings should promptly detect ECoG activity and not detect on baseline activity.

Based on the clinical response, the physician may choose to modify stimulation. If so, it is recommended that the current amplitude be increased in 0.5 mA increments, and that new settings be tested (see Test Stimulation Before Enabling on page 77) to ensure that it is well tolerated by the patient and there are no undesired changes in the ECoG such as afterdischarges.

• Review data such as lead impedance, battery voltage, number of detections and stim ulations, and stored ECoGs.

• Adjust stimulation settings if the patient reports an acute worsening or increase in clinical seizures that is not typical.

• Consider making minor adjustments if the patient reports only a mild or no improvement in clinical seizures.

• Allow sufficient time between stimulation adjustments to assess the patient’s clinical seizure response.

In the RNS therapy options (see T ab le 1). These were: pattern specific therapy (each detector triggers a different stimulation setting); adaptive therapy (the stimulation frequency adjusts with the ECoG frequency); synchronized stimulation (stimulation is delivered into a specific part of the ECoG waveform); and post episode interval (responsive therapies are disabled for a specified period of time after detecting the end of the episode). Table 1 provides the number and percentage of subjects who were treated with any of the additional stimulation therapy options.

System Pivotal study very few subjects used any of the additional responsive stimulation

Table 1: Additional responsive stimulation therapy options

Number and (%) of

Subjects Programmed

Pattern Specific Therapy 29 (15%) Adaptive Therapy 4 (2%) Synchronized Stimulat ion 3 (2%) Post-Episode Interval 4 (2%)

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Tablet Instructions 81

EXPORT AND IMPORT DEVICE SETTINGS FOR NEUROSTIMULATOR REPLACEMENT

The tablet supports the transfer of all device settings from an old to a new neurostimulator as part of a neurostimulator replacement procedure. With the E you can transfer all current neurostimulator settings (recording montage, detection settings, stimulation settings, etc.) to the new neurostim ulator .

Export and import are done directly through the tablet without using the PDMS—exported settings are kept locally on the tablet—so no Internet connection is required. This also means that the programmer to which the settings have been exported must be physically present with the new neurostimulator to import settings to the new neurostimulator. This is not usually an issue because export and import are done on the same day: before, during or after the procedure to replace the neurostimulator.

Transfer Compatibility

You can transfer settings from an RNS-300M to an RNS-300M or to an RNS-320, and you can transfer settings between RNS-320 devices.

XPORT DEVICE SETTINGS and IMPORT DEVICE functions,

Note: S

CHEDULED IMPEDANCE is a new feature in the RNS-320. It allows you to select which

electrodes to test for impedance. Since the feature is not present in the RNS-300M, you must select the electrodes to test (and confirm programming) on the new RNS-320 before scheduled impedance works. Its settings are created as part of the recording montage—see Create the Recording Montage on page 32 for instructions.

Export Neurostimulator Settings

1. Interrogate the old neurostimulator, the one from which you will transfer settings.

2. Select the U

TILITIES (toolbox) icon at upper right of the screen. The UTILITIES dialog opens.

Figure 66 Utilities dialog

3. Select EXPORT DEVICE SETTINGS. You are done. All current neurostimulator settings are stored on the tablet ready for import.

Note: The tablet retains only the last device settings exported to it—from any neurostimulator. Every export operation from any neurostimulator overwrites these device settings, if any. Successfully importing and programming the settings from the tablet to a new neurostimulator also deletes these device settings from the tablet.

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Tablet Instructions 82

Import Neurostimulator Settings

1. Interrogate the new neurostimulator, the one to which you will transfer settings .

2. Select the U

3. Select I

TILITIES (toolbox) icon at upper right. The UTILITIES dialog opens (see figure above).

MPORT DEVICE. The IMPORT DEVICE SETTINGS dialog appears. It shows the device settings

available for import by device serial number and the date and time of last interrogation before the settings were exported to the tablet. It also notifies you if the tablet has no settings that came from a compatible neurostimulator (for example, if you exported from an RNS-320 for use on an RNS-300M).

Figure 67 Import Device Settings dialog

Note: Device settings can be imported only once because they are delete d from the tablet once you successfully import and select C below.

ONFIRM PROGRAMMING from the REVIEW screen, as desc r ibed

4. Select the device settings—the selected settings will be highlighted—and then select I dialog notifies you that it is importing device settings.

When complete, the tablet Home screen opens. It will include a red R

EVIEW & PROGRAM tile at

lower right.

Figure 68 Home screen with the red Review & Program tile at lower right

MPORT. The

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Tablet Instructions 83

5. Select REVIEW & PROGRAM. The REVIEW screen opens, showing all the settings that will be programmed.

• If you want to enable detection and stimulation at this time, make sure D

TIMULATION are set to ENABLED at upper center.

ETECTION and

6. Place the wand within approximately 1 inch of the neurostimulator and select C

ONFIRM

PROGRAMMING. The PROGRAMMING NEUROSTIMULATOR dialog shows programming progress until

complete. The imported settings are deleted from the tablet when programming is complete. If you do not complete this step, the settings will remain available on the tablet.

Note: After implanting a replacement neurostimulator, monitor the detection behavior. It may be necessary to adjust the detection settings to ensure desired performance. If a bandpass detection tool (R

HYTHMIC ACTIVITY or SPIKE ACTIVITY) is enabled and the settings need to be adjusted, begin

by modifying the amplitude settings. See Recommended Therapy Modifications After Observing Clinical Response on page 80.

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Patient List on Programmer and the PDMS on a PC 84

PATIENT LIST ON TABLET AND THE PDMS ON A PERSONAL COMPUTER

The PATIENT LIST on the tablet and the PDMS on a personal computer give access to stored data for a selected patient. Their appearance and behavior is the same. The P screen works only when the tablet is connected to the PDMS (through the Internet).

ATIENT LIST tile on the tablet Start

Figure 69 Tablet Start screen

Whether you select PATIENT LIST on the tablet Start screen or log in to the PDMS on a personal computer, the information is displayed in a similar way, and on the same-named screens, as when you start an interactive programming session by interrogating the neurostimulator. When you select P the tablet, the differenc e is that you are not inter actin g w ith a neurostimulator; you are only accessing stored neurostimulator information like detection and stimulation settings, and stored activity reports.

ATIENT LIST on

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Patient List on Programmer and the PDMS on a PC 85

PDMS ACCESS ON A PERSONAL COMPUTER

Access to the secure PDMS database on a personal computer requires a username and password. If NeuroPace has not already provided these to you, contact NeuroPace to obtain a username and temporary password. You are responsible for maintaining the confidentiality of your username and password.

Note: The PDMS requires you to change your password after logging in for the first time.

1. Using any computer with Internet access, open a web browser and select the PDMS link on

www.neuropace.com

2. Enter your USERNAME and PASSWORD.

3. Click L

Figure 70 PDMS Login on a personal computer

OG IN.

Note: If you have forgotten your password select RESET YOUR PASSWORD OR ACCESS YOUR

PASSWORD HINT

. The password hint you entered will be sent to the email address listed in your

profile.

The P

ATIENT LIST opens immediately when you log in to the PDMS using a web browser, just as when

you select the P

ATIENT LIST tile on the tablet. Follow the continuing instructions below to access

PDMS functions, which apply both on the tablet and on a personal computer.

PDMS PROFILE AND SETTINGS

The toolbox icon at upper right of every screen gives access to view and change your:

• Profile

• Password

• Time Zone

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Patient List on Programmer and the PDMS on a PC 86

1. To reach the PATIENT LIST on the tablet, select PATIENT LIST from the Start screen. The

ATIENT LIST screen opens. When you log in to the PDMS via a web browser, it opens

directly on the P

ATIENT LIST screen.

Figure 71 Patient List screen

2. Select a patient from the PATIENT LIST. The PATIENT HOME screen opens.

Figure 72 Patient Home screen

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Patient List on Programmer and the PDMS on a PC 87

3. Select a tile to view its associated data for this patient.

ATIENT & NEUROSTIM INFO

• P

EUROSTIM SETTINGS

• N

CTIVITY

• A

• EC

• L

OG LIBRARY

IVE ECOGS

You can switch between patient views or return to the P screen title at upper left (or the down arrow next to it).

Figure 73 Select to switch between patient views

The following sections provide details about each view.

ATIENT HOME screen by touching the

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Patient List on Programmer and the PDMS on a PC 88

PATIENT & NEUROSTIM INFO

Figure 74 Patient & Neurostim Info screen

This screen provides:

• At upper left, patient information.

• At lower left, whether D

ETECTION and STIMULATION are ENABLED or DISABLED.

• At upper right, information about the neurostimulator (serial number, implant date), leads, and

electrodes.

• At lower right (swipe up to see), graphs of battery and impedance measurements over time.

NEUROSTIM SETTINGS

• This NEUROSTIM SETTINGS screen gives access to the PATTERN DETECTION, STIMULATION and EC

OG CAPTURE screens. These have the same names as found through the NEUROSTIM

SETTINGS screen after you interrogate the neurostimulator. Here are the similarities and

differences:

ATTERN DETECTION screen: It looks exactly the same as seen in Figure 32 Pattern

• P

Detection screen (page 48). It behaves the same in that you can define, modify, and save pattern detection settings for the current patient, with one difference: you cannot program the new settings immediately. You can program the settings later when the programmer is in communication with the patient’s neurostimulator (after interrogation). For instructions to use this screen, see Configure Pattern Detection: Define and Modify Detection Settings (page 44), starting with Phase 2: Define a Pattern Detection Set (page 48).

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Patient List on Programmer and the PDMS on a PC 89

• When accessing the PDMS via a web browser (not via the tablet), you can define or edit and save a detection set to the PDMS, and later download the detection set to the programmer. Having saved a detection set to the programmer, you can program the neurostimulator while the programmer is offline, as is required, for example, if an operating room lacks network connectivity. Note that these instructions apply whether the target programmer is a model PGM-300 (laptop) or model 5000 (RNS

TIMULATION screen: This screen enables you only to review the patient’s history of

• S stimulation settings. You can adjust stimulation settings only using the tablet during an interactive programming session. See Configure Responsive Therapy on page 70.

Tablet).

Figure 75 Stimulation screen through the patient list—review settings history only

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Patient List on Programmer and the PDMS on a PC 90

• ECOG CAPTURE screen: This screen reports the current capture settings. You cannot adjust them here. You can adjust ECoG capture settings only using the tablet during an interactive programming session. See Set up ECoG Capture on page 38.

Figure 76 ECoG Capture screen through the patient list—review current settings only

ACTIVITY

The ACTIVITY screen is a reporting screen only. It looks and behaves as shown and explained under

Activity Screen starting on page 23.

ECOG LIBRARY

The ECOG LIBRARY screen is a reporting screen only. It looks and behaves as shown and explained under ECoG Library Screen starting on page 29.

LIVE ECOGS

The Live ECoGs tile is inactive through the patient list and the PDMS via the Internet. It can be active only on the tablet, provided it is in communication with a neurostimulator, as described under Live ECoGs Screen starting on page 31.

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Patient Follow-Up Activities 91

PATIENT FOLLOW-UP ACTIVITIES

The following activities are recommended at a follow-up visit:

• Interrogate the RNS

• Review measured batter y voltage and el ec trode impedance on the Neurostim Info Screen—

see page 20. These are measured routinely during interrogation.

Note: Battery voltage and electrode impedance are measured during interrogation. If these two values were not measured (e.g., because therapy was being delivered), measure them manually using the applicable M

• Review stored ECoGs on the ECoG Library Screen—see page 29—to review and consider adjustments to:

• ECoG capture settings—see Set up ECoG Capture on page 38

• Detection settings—see Configure Pattern Detection: Define and Modify Detection

Settings on page 44

• Responsive therapy settings—see Configure Responsive Therapy on page 70

Note: You must be connected to the PDMS via the Internet to review stored ECoGs, neurostimulator activity and all other neurostimulator information in a patient’s history. See Connect and Login Overview on page 10.

Neurostimulator. See Interrogate the RNS® Neurostimulator on page 16.

EASURE button on the NEUROSTIM INFO screen.

• View live ECoGs—see Live ECoGs Screen on page 31.

• If you adjust detection settings, review the simulated detection on an ensemble of stored ECoGs

before programming. See Phase 2: Define a Pattern Detection Set on page 48 or Phase 3: Customize Pattern Detection on page 52.

• If you adjust stimulation settings, test the patient’s tolerance for the new settings before programming. See Test Stimulation Before Enabling on page 77.

• If you change any settings, remember to program the new settings into the neurostimulator, as described in each applicable section.

Caution: Afterdischarge Activity

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Troubleshooting 92

TROUBLESHOOTING

Note: This section addresses only problems specific to the RNS® Tablet. For troubleshooting information regarding other components of the RNS troubleshooting informat ion regard ing the Neur o Pac e

System, see the RNS® System manual. For

Remote Monitor, see the NeuroPace®

Remote Monitor Manual.

If the information in this section does not resolve the problem, contact NeuroPace for further assistance (see Contacting NeuroPace on page 4).

Network Connectivity Problems

For an overview and step-by-step instructions to establish full network connectivity with the tablet, see Connect and Login Overview on page 10 and following.

If you are already logged in to the tablet and have lost network connectivity, first log off to return to the login screen: return to the Start screen (see Figure 3 Start screen on page 15) and touch the circle-X (exit) button at upper right, and then select E

XIT on the PROGRAMMER EXIT dialog. Follow the

instructions under Connect to the Internet for PDMS Access on page 10 to establish a connection.

• If a PDMS screen appears to get “stuck” or is not responding, select the R

EFRESH button at

upper right.

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

Troubleshooting During an Intraoperative Procedure The goal of the following procedures is to ascertain if the abnormal lead impedance measurement is

associated with the lead or with the RNS

Neurostimulator port to which the le ad i s connec ted .

1. Repeat the impedance measurements.

2. If the impedance remains abnormal, note the electrode label ass ociate d w ith the a bnormal

impedance

3. Reconnect leads in the same neurostimulator port.

• Disconnect and reconnect the leads to the connector cover and neurostimulator

according to the instructions in the relevant section of the system manual.

• View the live ECoGs to verify that the signal is sufficient and without noise or artifacts.

• Repeat impedance measurements.

4. If the impedance remains abnormal, note the electrode label associated with the abnormal

impedance.

5. Place leads in the opposite neurostimulator port.

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Troubleshooting 93

• Disconnect leads, place leads in the opposite connector cover ports, and reconnect the

connector cover and neurostimulator according to the instructions in the relevant section of the system manual.

• Program the new lead information and montage and use the same electrode labels for

the new lead configuration.

• View the live ECoGs to verify that the signal is sufficient and without noise or artifacts.

• Repeat impedance measurements.

Note: If the abnormal impedance is associated with the same electrode label, then the problem may be with the lead.

Depth lead - Impedance > 3500 Ohms

• The depth lead may be damaged and should be replaced. Refer to instructions in the

relevant section of the system manual.

Depth lead - Impedance < 250 Ohms

• The depth lead may be damaged and should be replaced. Refer to the instructions in the

relevant section of the system manual.

Cortical strip lead - Impedance > 3500 Ohms

• The high impedance may be due to air.

• Irrigate the area around the cortical strip lead and examine the geometry.

• Repeat impedance measurements.

• If the impedance remains abnormal, the cortical strip lead may be damaged and should

be replaced. Refer to the instructions in the relevant section of the system manual.

Cortical strip lead - Impedance < 250 Ohms

• The cortical strip lead may be damaged and should be replaced. Refer to the instructions

in the relevant section of the system manual.

Note: If the abnormal impedance is not associated with the same electrode label, the problem may be with the neurostimulator or connector cover.

6. Replace the connector cover.

• Disconnect the leads from the connector cover and reconnect the leads to a new

connector cover. Connect to the neurostimulator and troubleshoot according to the instructions in the relevant section of the system manual.

• View the live ECoGs to verify that the signal is sufficient and without noise or artifacts.

• Repeat impedance measurements.

7. If the impedance remains abnormal, replace the neurostimulator. Refer to instructions in the

relevant section of the system manual.

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Troubleshooting 94

Troubleshooting During a Routine Follow-up

1. Repeat lead impedance measurements to verify abnormal lead impedance.

2. Take an image (X-ray or CT scan) of the implanted lead(s) and connector cover to discern

the integrity of the lead.

• Lead Damage – If the lead is damaged or fractured, it is recommended to abandon and

replace the lead. Refer to the instructions in the relevant section of the system manual.

• Poor Connection – If the lead is not completely installed in the connector cover, it is

recommended to surgically revise the connection between the connector cover and lead. Refer to the instructions in the relevant section of the system manual.

Note: It is normal for lead impedance measurements to fluctuate following the implant procedure due to the acute injury and healing processes of the brain tissue.

Note: Lead damage may not be immediately apparent from the live ECoGs. Using the N ECoG capture trigger may be helpful in future troubleshooting techniques.

OISE

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Troubleshooting 95

Insufficient Charge

Insufficient charge occurs when the neurostimulator is unable to fully deliver the programmed therapy. It may be due to high lead impedance or the neurostimulator configuration settings. If you receive an insufficient charge alert (see Figure 9 and Figure 10 on page 22) that cannot be explained by observed lead impedance changes, or if the first entries in the PDMS interrogation report event list show the “Programmed current” is higher than the “Lowest delivered” current, contact your NeuroPace Field Clinical Engineer. The NeuroPace Field Clinical Engineer will help you review the neurostimulator configuration settings to determine the cause. An example interrogation report is shown below in Figure 77.

Top of detailed report shows alerts

Bottom of detailed report shows specific bursts delivered below programmed current levels

Figure 77 Accessing an interrogation report that shows insufficient charge

Select to open detailed report

Noise, Artifacts, Poor Signal Displayed, or No Signal Displayed in Live ECoG

Troubleshooting During an Intraoperative Procedure

1. If no ECoG signal is seen, make sure the recording montage has been programmed.

2. If the signal is too high in amplitude or saturating, decrease the gain setting.

3. If the leads are positioned over the RNS

Neurostimulator, move them away from the

neurostimulator.

4. Remove the connector cover from the RNS

5. Flush the connector cover (with leads inserted) and the RNS

Neurostimulator using the torque driver.

Neurostimulator connector

area with saline.

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Troubleshooting 96

6. Remove the leads from the connector cover. Clean the proximal end of the lead with saline

and visually inspect that the lead end is free of excess blood or other tissue.

7. Reinsert the leads. Verify that they are fully inserted into the connector cover ports.

8. Place the connector cover back onto the RNS

leads are fully inserted in the connector cover ports.

9. Secure the connector cover onto the RNS

10. View the live ECoGs to verify that the signal is sufficient and free of noise or artifacts. Isolated

artifacts may be the result of electrostatic discharge (ESD) / static electricity shocks to the tablet.

11. If the signal contains noise or artifacts, disconnect the AC adapter from the tablet and run on

battery power. (Make sure the battery is charged before doing so.) Disconnect the network cable as well if it is connected.

12. If the signal is not sufficient or still contains noise or artifacts, measure the impedances. If the

impedances are out of range, follow the instructions in the relevant section of the system manual.

13. If impedance measurements are normal, but the problem remains, try using a different tablet,

if available.

Neurostimulator. Verify, once again, that the

Neurostimulator using the torque driver.

14. If the problem persists, replace the neurostimulator. Refer to the relevant section of the

system manual.

Troubleshooting During a Routine Follow-up

1. Reposition the wand over the RNS® Neurostimulator and interrogate again.

2. If the signal is not sufficient, follow the Poor or No Communication Between the RNS®

Neurostimulator and the RNS® Tablet instructions in this section.

3. If the signal is not sufficient, measure the impedances. If the impedances are out of range,

follow the instructions in the relevant section of the system manual.

Poor or No Communication Between the RNS® Neurostimulator and the RNS® Tablet

1. Confirm that the wand cable is inserted securely into the USB port on the tablet.

2. Confirm that the concave side of the wand faces the neurostimulator and that the wand is

within approximatel y 1 inch of the neurostimulator.

3. Disconnect the AC adapter from the tablet and run on battery power. (Make sure the battery

is charged before doing so.) Disconnect the network cable as well if it is connected.

4. Move electronic equipment that may be a source of interference or move away from such

equipment if possible. (Turning electronic equipment on and off may help identify the source of any interference.)

• Reposition the wand over the neurostimulator and interrogate.

• View the live ECoGs to verify that the signal is sufficient and void of noise or artifacts.

5. Restart (turn OFF and back ON) the tablet. Attempt the interrogation again.

6. Try a different tablet, if available.

RNS® System Programming Manual