PDMS User Manual

Rev Date: 2017-01 DN 1014955 Rev 6

Patient Data Management System

User Manual Model 4340

© 2016 NeuroPace, Inc.

Table of Contents 3

TABLE OF CONTENTS Introduction ................................................................................................................................................. 5

Contacting NeuroPace.............................................................................................................................. 5 About this Manual ..................................................................................................................................... 5 Typographic Conventions ......................................................................................................................... 5

NeuroPace® Patient Data Management System ....................................................................................... 6 Overview of the PDMS ............................................................................................................................. 6

PDMS Basics ............................................................................................................................................... 7 Obtain a PDMS Account ........................................................................................................................... 7 Access the PDMS ..................................................................................................................................... 7 Your PDMS Profile .................................................................................................................................... 8

Use the PDMS ............................................................................................................................................ 10 View the Patient List ............................................................................................................................... 10 View the Patient Summary ..................................................................................................................... 10 View Reports .......................................................................................................................................... 17 Neurostimulator History .......................................................................................................................... 20 Configure Detection ................................................................................................................................ 23 View Programming Epochs .................................................................................................................... 31 View Patient Info ..................................................................................................................................... 32 Exit the PDMS ........................................................................................................................................ 32

Troubleshooting ........................................................................................................................................ 33 Connection to the PDMS ........................................................................................................................ 33 RNS® System Troubleshooting ............................................................................................................... 33

Introduction 5

INTRODUCTION

Contacting NeuroPace

All questions or concerns regarding the NeuroPace® Patient Data Management System should be forwarded to:

NeuroPace, Inc. 455 N. Bernardo Ave. Mountain View, CA 94043

Customer Support: 1-866-726-3876 (Toll Free in the United States) Website: www.NeuroPace.com

About this Manual

This manual is intended to provide instructions for using the NeuroPace® Patient Data Management System. Additional information is presented on the Patient Data Management System website.

This is a reference manual supporting the NeuroPace® RNS® System. For further information about the RNS® Neurostimulator, NeuroPace® Programmer, and NeuroPace® Remote Monitor see the RNS® System User Manual and the NeuroPace® Remote Monitor Manual available at www.NeuroPace.com or by contacting NeuroPace, Inc.

Typographic Conventions

This manual uses different formats and symbols to distinguish notes and instructions.

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

1. Numbered paragraphs contain instructions that provide procedural information.

BOLD SMALL CAPS identify text or user-selectable buttons on the NeuroPace® Patient Data Management System website pages.

BOLD SMALL CAPS BOLD SMALL CAPS: phrases or words in BOLD SMALL CAPS separated by an arrow ( ) indicate a sequential series of commands to be selected on the NeuroPace® Patient Data Management System website pages.

http://www.neuropace.com/


Patient Data Management System 6

NEUROPACE® PATIENT DATA MANAGEMENT SYSTEM

Overview of the PDMS

The NeuroPace® Patient Data Management System (PDMS) is used to store and provide access to historical RNS® Neurostimulator data and patient data.

The RNS® Neurostimulator stores data until interrogated by either the NeuroPace® Programmer or the NeuroPace® Remote Monitor. Interrogation transmits data from the neurostimulator to the programmer or remote monitor. When the programmer or remote monitor is synchronized via a secure internet connection to the PDMS, the data are transmitted to the PDMS. The data are stored on the PDMS and can be accessed by authorized users through the PDMS website using a secure web browser.

The PDMS can also be used to create and simulate detection settings. The detection settings can then be sent to a user identified programmer for use at a later date.

PDMS Basics 7

PDMS BASICS

Obtain a PDMS Account

A user name and password are required for user authentication and access to the PDMS. Contact NeuroPace to obtain a user name and temporary password. You are responsible for maintaining the confidentiality of your user name and password.

Note: You are required to change the password after accessing the PDMS for the first time.

Access the PDMS

1. Using any computer with internet access, select the PDMS link at www.neuropace.com.

2. Enter your USER NAME and PASSWORD.

3. Click LOG IN.

NOTE: If you have forgotten your password select PASSWORD HINT. The password hint you entered will be sent to the email address listed in your profile.


PDMS Basics 8

Your PDMS Profile

View and Edit Your Profile

Profile settings can be viewed and modified by selecting MY PROFILE, which is located on every page in the upper right corner. To change your profile, select MY PROFILE EDIT MY PROFILE.

PDMS Basics 9

Edit Your Password

To change your PDMS password or password hint, select MY PROFILE EDIT MY PASSWORD. The password hint will be sent to the email address listed in your profile if you forget your password and access your password hint from the log in screen.

Edit Your Time Zone

The PDMS displays RNS® Neurostimulator event timestamps in the time zone of your choice. Some information may be time stamped in a different or preferred time zone. To change your time zone, select MY PROFILE EDIT MY TIME ZONE.

Use the PDMS 10

USE THE PDMS

View the Patient List

A list of patients at your center is shown immediately following login. Each patient listing includes the Patient Name, Gender, Patient ID, Most Recent Neurostimulator Implant Date and First Neurostimulator Implant Date. The patient list can be sorted by clicking any of the column titles. In the example, the patient list is sorted by the Most Recent Neurostimulator Implant Date as indicated by the arrow next to the column title.

Alert icons will be displayed next to the patient’s name if the patient’s neurostimulator has a low battery, a depleted battery, or has been reset.

The patient list can also be accessed by selecting PATIENT LIST, which is located on every page in the upper right corner.

View the Patient Summary

The patient summary is accessible by selecting PATIENT LIST Select a Patient PATIENT SUMMARY. A PDF of the patient summary is available by selecting PRINTER FRIENDLY VERSION (PDF) at the top of the summary.

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The patient summary provides an overview of each patient’s neurostimulator data to provide support before and during a patient visit. The patient summary contains the following information:

• Checklist (a guide for follow-up visits) • Alerts • Neurostimulator Summary • Battery Measurements • Lead Summary • Lead Impedance Measurements • Neurostimulator Event Histograms • Programming Epoch Summary • Week by Hour Histogram • ECoG examples:

o Detection Examples Since Last Programming o Long Episode o Magnet o Saturation o Scheduled

• Therapy Settings • Programmer and Remote Monitor Summary • Most Recent Programming Changes

Checklist

The checklist provides a guide for your use during follow-up visits.

Alerts

Alerts are only displayed if they apply to the patient summary that is being reviewed. Alerts should be addressed at, or prior to, the next patient visit. There are three alert types.

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Neurostimulator Summary

The neurostimulator summary provides the neurostimulator’s serial number, implant date (and the amount of time that has passed since the implant) and most recent battery voltage measurement (as of the date of the last synchronized interrogation).

Battery Measurements

The battery measurements summary provides historical data on the neurostimulator battery voltages.

Lead Summary

The lead summary provides the description of the lead, anatomical labels and the most recent lead impedance measurements (as of the date of the last synchronized interrogation).

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Lead Impedance Measurements

The lead impedance measurements provide historical lead impedance values.

Neurostimulator Event Histograms

Individual histograms plot neurostimulator events: detection episodes, long episodes, saturations and magnet placements. The example histogram provides detection episodes.

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Programming Epoch Summary

The programming epoch summary displays a recent history of neurostimulator programmed setting that occurred between two programming dates. The blue highlights identify settings that have changed since the last programming.

Week by Hour Histograms

The week by hour histogram provides the distribution of detections per hour on a weekly basis for the most recent 12 weeks.

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ECoG Examples

ECoG examples are thumbnail views of the most recent six to eight ECOGs uploaded by either a Programmer or Remote Monitor to the PDMS for the following categories: detections, long episodes, magnet placements, saturations and scheduled ECoGs. You can click on an ECoG thumbnail to open the ECoG report. The example ECoG provides detection episodes.

Therapy Settings

Therapy settings provide the details of the current therapy settings.

Programmer and Remote Monitor Summary

The programmer and remote monitor summary provides the most recent date that data from the programmer and the patient’s remote monitor were transferred to the PDMS, as well as the most recent interrogation date that was transferred.

Most Recent Programming Changes

The most recent programming changes summary provides both the programming dates and any changes made to detection settings, ECoG settings, montage settings, therapy settings and restricted settings.

Use the PDMS 16

Use the PDMS 17

View Reports You can review a patient’s reports by selecting PATIENT LIST Select a Patient REPORTS.

Each report listing includes the date of the report, the report type and relevant additional information such as an ECoG thumbnail. You can filter the chronological list of reports by MONTH, REPORT TYPE, ECOG TRIGGER and ECOG CATEGORIZATION.

These are the available patient reports and the information they provide:

• Programming o Programming date and time o Programmed neurostimulator settings

• Interrogation (initial or subsequent within the programming session) o Interrogation date and time o Programmed neurostimulator settings o Event counters (# of detections, stimulations, etc.) o Event date, time and details

• Impedance Measurement o Impedance measurement date and time o Impedance measurement of each individual electrode (in ohms)

• Therapy Testing (displays therapy testing values) • ECoG

o Event time and date o ECoG record o ECoG trigger reason o ECoG markers (detections, stimulations, etc.)

• Battery Measurement • Neurostimulator Replacement

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View Neurostimulator Reports

To view interrogation, programming, or impedance measurement reports click on the report hyperlink provided under report type. Therapy testing, battery measurement and neurostimulator replacement report data are provided directly under additional information.

View ECoG Reports

To view an ECoG report, click on an ECoG thumbnail under additional information.

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The ECoG report provides three visualizations of the ECoG. The top panel of the report displays the entire ECoG record

The middle panel of the report displays the spectral domain signal. The X-axis units are time in seconds. The Y-axis units are frequency from 0 Hz at the bottom to 125 Hz at the top. The amount of power present at each frequency is conveyed by the “hotness” of the color with red being the highest power and blue being the lowest.

The bottom panel of the report displays a larger, scrollable ECoG. The gain, timebase, image size and format can be adjusted for a more detailed review.

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Categorize Electrocorticograms (ECoGs)

You have the option to categorize ECoGs under the report type column by selecting a category from the drop-down list located next to each ECoG thumbnail. In the example below, an ECoG category of “Epileptiform activity” is selected.

Neurostimulator History

The neurostimulator history page provides a histogram view of historical neurostimulator data. To review the historical data select PATIENT LIST Select a Patient NEUROSTIMULATOR HISTORY. To view how the neurostimulator settings changed at a particular programming click on a blue vertical programming epoch line. To add or remove information in the graphs use the check boxes at the bottom of the neurostimulator history page.

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You can review a narrower timeframe by left clicking and dragging over an area of interest on either of the histograms.

The top histogram will continue to show the entire set of data with a highlight over the selected timeframe. The larger, lower histogram will display just the selected timeframe.

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Use the PDMS 23

Configure Detection

You can view and analyze existing ECoGs to create detection sets. You can download saved detection sets to a NeuroPace® Programmer so that they can be accessed during future programming sessions. To configure detection select PATIENT LIST Select a Patient CONFIGURE DETECTION.

Although detection sets can be created and modified using either the PDMS or the NeuroPace® Programmer, it is recommended that these activities be carried out on the PDMS, for reasons of convenience. However, only the NeuroPace® Programmer can be used to program the new settings into the Neurostimulator.

Note: When configuring detection on the PDMS (as opposed to on the Programmer), it is not necessary to create ECoG sets for detection simulation. The PDMS is 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.

Configuring pattern detection has three phases:

• In Phase 1, you select a default detection set to gather an initial collection of ECoGs. This is usually configured and programmed in the operating room immediately after implantation.

• In Phase 2, after initial ECoGs have been stored, you review the stored ECoGs and identify the specific ECoG patterns to be detected. The system provides a starting point for this process. It is a tool to assist you as you exercise clinical judgment to define detection settings. It suggests a starting point only. It neither preempts nor replaces your clinical judgment. This is usually programmed at the first visit post-implantation.

• In Phase 3, 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.

To 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 then modify the parameters of the suggested starting detection set to make detection more or less sensitive, or to detect earlier or later. 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, either with the sliders or with the drop-downs.

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.

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The configure detection page provides everything you need to configure and simulate a detection set. The configure detection page includes:

Currently programmed detection set

Two detection channels

ECoG filters (MONTH, TRIGGER AND CATEGORIZATION)

Six ECoG thumbnails

Note: Click the arrow on either side of the ECoG thumbnails to view additional ECoGs.

Modify a Detection Set

Detection sets can be modified and performance simulated for the available ECoGs. You can use simulation to make the detection more or less sensitive to the electrographic activity of interest. Detection settings should promptly detect ECoG activity and not detect on baseline activity. Before you modify a detection set review several ECoGs to determine which channels and detectors need to be adjusted.

1. From the CONFIGURE DETECTION screen do one of the following:

a. Select one of the two available channels

b. Select an ECoG of interest then select which channel to modify.

Note: Channel 2 and Channel 4 can be modified if they are detection channels.

2. To modify the existing detection from the define pattern screen:

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

a. Adjust the sliders to increase or decrease the sensitivity of the parameters.

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Note: Generally, moving the sliders to the right will increase sensitivity and result in more detections. The arrows next to the sliders can be used to make more precise changes to the detection parameters

b. Select MORE CONTROLS and change the additional parameters.

The arrows can be used to open the drop-down list and adjust the additional parameters. This example displays the frequency controls for the bandpass detector.

Note: If you want to modify the remaining channel repeat these steps.

3. Click DONE to close the define pattern screen.

4. Click SAVE on the configure detection screen to save your changes.

The save detection set window will be displayed.

Use the PDMS 26

5. Type a name for the detection set and click SAVE.

Note: You can also send the detection set to a user and the programmer.

Note: Although detection sets can be created and modified using either the PDMS or the NeuroPace® Programmer, only the NeuroPace® Programmer can be used to program the new settings into the Neurostimulator.

Create a New Detector

A detection set is comprised of one to four detectors, each independently configured by the user. Each detector uses one detection tool on one channel. No more than two detectors may be defined on a single channel. The patterns defined on a specific channel can operate only in that selected ECoG channel.

The creation of a new detector requires that you create a Region of Interest (ROI) for the selected ECoG. In order to create a new ROI you will need to begin with an available pattern for the selected channel.

You will use this procedure initially 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 neither preempts nor replaces your clinical judgment.

Typically, you will return to this process for creating a detection set from an ROI only if you observe a new type of ECoG activity requiring an additional detector or if a good clinical response has not been obtained and you wish to start over.


a. Select one of the two available channels.



2. Click CLEAR to remove one of the existing pattern detections and click CLEAR again on the confirmation window to confirm your selection.

Use the PDMS 27

3. Evaluate the ECoG by adjusting the GAIN or ZOOM, or reviewing the FFT (Fast Fourier Transform).

4. Click on the ECoG where you want the ROI to begin. ROI (Region of Interest) is a 3-second window containing an example of the type of ECoG activity that the user would like to detect.

A new Region Of Interest (ROI) and a new detector is generated. The three second ROI region will be labeled with a “1” or a “2” to indicate pattern 1 or pattern 2 detection.

Note: You can adjust the location of the ROI by sliding (click and drag) the ROI outline.

5. You can adjust the pattern by changing the detection type, moving the parameter sliders and clicking MORE CONTROLS to modify additional parameters.

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Note: “Rhythmic Activity” and “Spike Activity” are both types of ECOG activity that can be detected by the Bandpass tool. “Power” is a type of ECOG activity that can be detected with the Line Length tool. The Area tool is not used when generating a detection set from an ROI, but can be manually programmed by choosing More Controls and then Adv Settings.


7. Click SAVE on the configure detection screen to save your changes.

The save detection set window will be displayed.

8. Type a name for the detection set and click SAVE. In order to program the detection set into the neurostimulator, you must send the detection set to the programmer.

Note: You can also send the detection set to a user.

Note: Although detection sets can be created and modified using either the PDMS or the NeuroPace® Programmer, only the NeuroPace® Programmer can be used to program the new settings into the Neurostimulator. Therefore, in order to program the detection set into the neurostimulator, you must first send the detection set to the programmer. After accepting the new detection set on the Programmer, it can be programmed into the neurostimulator directly. It is not necessary to re-run simulation on the Programmer.

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Change Detection Channels

If a more appropriate channel for detection is identified through ECoG review then you can select a new detection channel to optimize detection. Selecting a new detection channel clears all detection settings for the selected pattern.

Typically, you will create a new detection channel from an ROI as described here only if you observe a new type of ECoG activity requiring an additional detector or if a good clinical response has not been obtained and you wish to start over.


a. Select one of the two available channels.



Note: Click the arrows on the side of the ECoG thumbnails to view additional ECoGs.

2. Click the CHANGE CHANNEL button and click CHANGE on the confirmation window to confirm that the current detection settings will be removed.

3. Click on one of the four channels in the ECoG to select the new detection channel.

4. Select a Region Of Interest (ROI) and adjust the detection parameters by changing the detection type, moving the parameter sliders and clicking MORE CONTROLS to modify additional parameters. See Create a New Detector for more details.


ECoG Marker Legend

Click the info icon to open the Marker Legend to view all the ECoG markers and their meanings.

The info icon is available when modifying a detector or reviewing an ECoG.

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Revert to Prior Settings

You can cancel any changes made to the detection parameters by selecting the REVERT button located on the CONFIGURE DETECTION screen. The REVERT button only appears after changes have been made to at least one detection parameter.

Send a Detection Set to Another User

You can share detection sets with another PDMS user authorized to view the patient’s data.

1. Click CONFIGURE DETECTION SAVE.

2. Type a name for the detection set.

3. Select a user from the drop-down list to send the detection set.

Note: You can also send the detection set to the programmer at the same time by checking the box next to “Send detection set to Programmer”.

4. Click SAVE.

Send a Detection Set to the Programmer

You can indicate that you want to send the detection set to the programmer so that it can be used for a future programming session with the patient. The detection set will be sent the next time the programmer is synchronized with the PDMS.

1. Click CONFIGURE DETECTION SAVE.

2. Type a name for the detection set.

3. Check the box next to “Send detection set to Programmer”.

Note: Detection sets will only be sent to programmers that have previously interrogated this neurostimulator.

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4. Click SAVE.

View Programming Epochs

The programming epochs screen displays a history of RNS® Neurostimulator programmed settings as well as the daily count and monthly averages of detections, delivered therapies, magnet swipes, saturations, and long episodes that have occurred between two programming dates. To view this information, select PATIENT LIST Select a Patient PROGRAMMING EPOCHS. Clicking on the date of programming will redirect you to the programming report for that date.

The settings in blue are programming changes that were made on that date. A green down arrow indicates a value has decreased compared to the previous programming epoch. An orange up arrow indicates a value has increased compared to the previous programming epoch.

Note: If a patient does not interrogate for over 28 days, diagnostic data will be overwritten, so the diagnostic counts shown in the epoch summary become inaccurate. If a patient reaches their therapy limit per day then the episodes per day will be higher than the therapies per day.

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View Patient Info Patient information is accessible by selecting PATIENT LIST Select a Patient PATIENT INFO. This page provides detail on the patient, including information about the implanted neurostimulator.

Exit the PDMS You can log off of the PDMS at any time by selecting LOG OFF, which is located on every page in the upper right corner.

Note: You are automatically logged off whenever you exit the website, close the browser window, or after a period of 30 minutes without activity. Please note that changes made to your personal profile, reporting preferences or ECoG annotations may be lost if not saved prior to being automatically logged off due to inactivity.

Troubleshooting 33

TROUBLESHOOTING

Connection to the PDMS

If you are having trouble accessing the PDMS or during a PDMS session, try the following:

1. Ensure the internet connection is functioning properly.

2. Log off of the PDMS and then log back in. Next, try to access the website page that you want to view.

3. Close down your internet browser completely. Then open a new browser window and log back into the PDMS.

4. If you are still having trouble, record all error messages displayed and contact NeuroPace.

RNS® System Troubleshooting

See the RNS® System User Manual for help troubleshooting issues not related to the Patient Data Management System.

NeuroPace, Inc. 455 N. Bernardo Ave. Mountain View, CA 94043 Customer Support: 1-866-726-3876 (Toll Free in the US) Fax: 650-237-2855 Website: www.NeuroPace.com

Documents

PDMS User Manual