Vercise DBS Programming Manual Directions for Use Rev B

Vercise™ DBS Programming Manual

How to Use this Manual This manual describes the installation of the Boston Scientific Bionic Navigator software. Read all instructions carefully before using the DBS System. For indications for use, contraindications, warnings, precautions, adverse events, sterilization, component disposal, and storage and handling, refer to the Physician Manual for your Boston Scientific DBS System as listed in your DBS Reference Guide. For other device‑specific information not included in this manual or labeling symbols, refer to the appropriate DFU for your Boston Scientific DBS System as listed in your DBS Reference Guide.

Guarantees Boston Scientific Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity. Drawings are for illustration purposes only.

Trademark All trademarks are the property of their respective holders.

Technical Support There are no user serviceable parts. If you have a specific question or issue, contact your sales representative or call (833) DBS‑INFO or (833) 327‑4636.

Product Model Numbers Model Number DB‑1110‑C DB‑5110‑C DB‑5212‑C DB‑5500‑1 *DB‑7164 and NM‑7164 *DB‑7164‑R and NM‑7164‑R NM‑7165 NM‑7171 NM‑7113 NM‑4500 NM‑4502 DB‑4511 and NM‑4511 NM‑4512 DB‑7101‑204‑W10

Description Vercise IPG Kit Vercise ETS Vercise Remote Control Vercise Remote Control Kit Clinician Programmer Clinician Programmer (Refurbished) Keyboard Power Supply for Tablet Computer Tablet Pen IR Interface IR Interface Holder USB Serial Cable USB Splitter Bionic Navigator 2.04 (Win 10) Installer

*Applicable after installation of Bionic Navigator 2.04 (Win 10) (software version 9028287‑204)

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Table of Contents

Glossary... v Introduction... 1

Intended Use...1

Setting Up... 2

Connecting the Remote Control to the Clinician Programmer...2 Linking a Remote Control to a Stimulator...4 De‑linking a Remote Control from a Stimulator...6

Starting a Session... 7

Getting to the Start Screen...7 Understanding the Toolbar...8 Understanding the Common Buttons...9 Starting a New Patient Session...10 Creating a New Patient...10 Selecting an Existing Patient...10

Managing a Patient’s Profile... 11

Entering and Editing Patient Information...11 Entering Patient Notes...12 Viewing a Patient’s Case History...13

Configuring the Vercise DBS System... 14

Verifying the Vercise DBS System Configuration...14 Modifying the Lead Information...15 Swapping the Leads...15 Testing Impedances...16

Programming the Patient... 17

Stimulator Programmable Characteristics...17 Stimulation Output at Maximum Parameters vs. Impedance...18 Getting to the Programming Screen...19 Selecting an Area...19 Selecting Contacts...20 E‑Troll Mode...20 Custom Mode...21

Turning Stimulation On and Off for Individual Areas...22 Increasing and Decreasing the Amplitude...22 Increasing and Decreasing the Pulse Width...23 Increasing and Decreasing the Rate...23 Programming Multiple Areas...24 Programming Multiple Areas with the Same Rate...24 Programming Two Areas with Different Rates...24

Defining the Amplitude Range...25 Understanding the Charge Density Warnings...26 Naming the Areas...27 Naming the Program...27 Globally Turning Stimulation Off and On...27 Adjusting Patient Options...28 Changing the Stimulation Cycle...29 Defining the Stimulation Ramp Up Time...29 Activating or Deactivating Patient Amplitude Control...30 Setting Program Options as Patient Defaults...30 Vercise™ DBS Programming Manual 92161115-02 iii of vi

Vercise™ DBS Programming Manual

Managing Programs... 31

Getting to the Remote Screen...31 Understanding the Program Slots...32 Saving a Program...33 Activating a Program from the Remote Control Panel...33 Previewing a Program from the Remote Control Panel...34 Deleting a Program...34 Checking the Stimulator Battery Status and Viewing the Estimated Charging Time...35

Managing Programs in the Program Database... 36

Viewing Programs in the Program Database...36 Activating a Program from the Program Database...37 Previewing a Program from the Program Database...37 Deleting a Program from the Program Database...37

Creating Reports... 38

Choosing a Report...38 Patient Information Report...39 Generic Report...40 Patient List Report...41 Clinical Outcomes Report...42 Clinical Activity Report...43

Synchronizing Data... 44

Understanding the Synchronizing Data function...44 Installing a New Patient Card...44 Synchronizing Data...45 Deleting Patient Records...45

Using Additional Tools... 46

Viewing System Information...46 Backing Up Data and Logs . ...47 Measuring Field Potentials...47 Adding a Lead...47 Enabling and Disabling Auto Impedance...48 Viewing Information about Bionic Navigator...48

Clinician Programmer Management... 49

Adjusting CP Date and Time...49 Resetting ClinicUser Password...49 Update Password...49 Lost/Forgotten Password...50

Software Installation, Uninstallation, and Removal...50

Managing System Settings... 51

Viewing the System Settings...51 Adjusting the Default Pulse Width...51 Adjusting the Default Rate...51 Adjusting the Default Ramp Time...52 Selecting the Default Remote Control Language...52 Setting the Patient Name Display Preference...52

Addendum... 53

Programming...53 Reports...53 General Notes...53 Sync Data...53

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Glossary

Glossary Amplitude The assigned current during the stimulation pulse, measured in milliamperes (mA). Anode Electrode that is positively charged during the stimulation pulse (in the context of neurostimulation).

Area A set of stimulation parameters and contact assignments pertaining to a Lead; a program may consist of up to 4 areas. Battery The component of the Stimulator that stores and delivers energy to the implanted system. Cathode Electrode that is negatively charged during the stimulation pulse (in the context of neurostimulation). Charger An external device that is used to charge the battery of the implanted Stimulator. Contact An electrically conductive component on the Lead; a Lead typically has multiple contacts (sometimes used interchangeably with the term “electrode”). Charging The act of recharging the implanted battery of the Stimulator. Clinician Programmer The device that runs the Bionic Navigator™ software, used for configuring stimulation parameters. Frequency See Pulse Rate. Lead Made up of insulated wires and contacts; conducts electricity from the Stimulator to the contacts in the tissue. Patient Options The default parameter settings for a specific patient, as opposed to system default settings. Program The stimulation settings that may be active at a given time; a program may be comprised of up to 4 areas (see also Area). Program Database A list of programs that were once saved in the Stimulator (i.e., program history). Pulse Rate The number of pulses of electric current in one second, measured in Hertz (Hz) or pulses per second (pps). Pulse Width The duration of the pulse of electric current, measured in microseconds (μs). Ramp Up Time or Ramp Time The amount of time the Stimulator will take to increase stimulation from 0 mA to the programmed amplitude.

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Introduction

Introduction

Welcome to Bionic Navigator™ by Boston Scientific. Bionic Navigator is a software program that is used to set and adjust stimulation parameters for the Vercise™ DBS System. The goal of this Programming Guide is to maximize patient benefits by providing useful information and instruction to persons using Bionic Navigator on the Clinician Programmer. In the following pages, you will learn basic concepts, such as how to enter patient information, program a patient, and save patient programs to the Remote Control. You will also learn about additional features, such as creating reports and syncing data. If you have any issues with Bionic Navigator, please refer to the “Technical Support” section of this manual.

Intended Use Bionic Navigator is a software program that is used to set and adjust stimulation parameters for the Vercise DBS System.

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Vercise™ DBS Programming Manual

Setting Up

Connecting the Remote Control to the Clinician Programmer The Clinician Programmer (CP) communicates with the Stimulator via the Remote Control. The Clinician Programmer is connected to the Remote Control using an infrared (IR) link. The Remote Control uses a radio frequency (RF) link to communicate with the Stimulator. Programs can be loaded to the Clinician Programmer for previewing, activating, and changing stimulation parameters. Stimulation programs can also be saved to the Remote Control. CAUTION: Use only Vercise™ DBS System components with the Clinician Programmer. Failure to do so can result in inappropriate stimulation. CAUTION: The CP is not considered as equipment for the patient environment as defined by IEC60601‑1. The CP and the person using the CP should not be in physical contact with the patient while programming. To connect the Remote Control to the Clinician Programmer: 1 Power on the CP. 2 Log in as ClinicUser. If this is the first login, use “bsn” as a temporary password. You will be prompted to setup a new ClinicUser password when logging into the CP for the first time. The new ClinicUser password must be 10 or more characters in length. Note: In regions where software is installed by a third party, follow region‑specific guidance for the initial ClinicUser password. 3 Plug the USB to Serial Cable into the USB port on the Clinician Programmer. 4 Plug the serial end of the USB to Serial Cable into the matching end of the IR Interface. 5 Insert the IR Interface and Remote Control into the plastic holder to keep the IR windows aligned, as shown below.

1

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2

3

Setting Up

6 Position the patient within 18 inches (45 cm) of the Remote Control and orient the large surface of the Remote Control parallel to large surface of the Stimulator. Proper orientation will ensure a reliable communication link between the Clinician Programmer and the Stimulator. Note: A message will be displayed on the Clinician Programmer if the communication range is not satisfactory. 7 Turn on the Clinician Programmer and log in. 8 If only Bionic Navigator is installed on the Clinician Programmer (CP), click on the Bionic Navigator icon

to launch Bionic Navigator.

If more than one DBS software is installed on the CP, Click the Vercise Launcher icon Vercise DBS System icon

and select the

to start Bionic Navigator.

Note: Multiple programming software should not be run simultaneously on the same CP. 9 Press and hold the P button to unlock the Remote Control. Note: The Remote Control should be linked to the Stimulator (see the “Linking a Remote Control to a Stimulator” section of this manual). 10 Enter the Clinician’s screen on the Remote Control by pressing and holding both the simultaneously.

and P buttons

11 Press the P button to select “CP Mode.” The Remote Control will inform you that it is ready to communicate with the Clinician Programmer. Once the Remote Control is within range of the Stimulator, the Clinician Programmer will detect the Stimulator and begin communication.

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Vercise™ DBS Programming Manual

Linking a Remote Control to a Stimulator Linking is defined as the process of configuring the Remote Control to communicate with a specific Stimulator. To link a Remote Control that has been previously linked to a different Stimulator, you must first de‑link the Remote Control from the original Stimulator (see the “De‑linking a Remote Control from a Stimulator” section of this manual) and then link the Remote Control to the new Stimulator. To link a Remote Control to a Stimulator: 1 Press and hold the P button to unlock the Remote Control. The Remote Control will ask if you want to link it to a Stimulator. 2 Position the Remote Control within 18 inches (45 cm) of the Stimulator and orient the large surface of the Remote Control parallel to large surface of the Stimulator. 3 Press the P button to link the Remote Control with the Stimulator or cancel by pressing the 4 Confirm the link by pressing the P button or cancel by pressing the If programs are stored in the… Remote Control Stimulator Remote Control Stimulator

Remote Control Stimulator

Remote Control Stimulator

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button.

button.

Then… The Remote Control will automatically download the programs from the Stimulator.

The Remote Control will automatically download the programs from the Stimulator. The Remote Control will ask if you want to download the Remote Control programs to the Stimulator. Enter the password A‑B‑C to download the Remote Control programs to the Stimulator. The Remote Control will be linked to the Stimulator immediately.

Setting Up

If programs are stored in the…

Then… The Remote Control will prompt you to clear the programs on the External Trial Stimulator.

Remote Control External Trial Stimulator

Then, the Remote Control will ask if you want to download the Remote Control programs to the External Trial Stimulator. Enter the password A‑B‑C to download the Remote Control programs to the External Trial Stimulator.

Remote Control External Trial Stimulator

Remote Control

The Remote Control will prompt you to clear the programs on the External Trial Stimulator.

The Remote Control will ask if you want to download the Remote Control programs to the External Trial Stimulator.

External Trial Stimulator

Enter the password A‑B‑C to download the Remote Control programs to the External Trial Stimulator.

Remote Control

The Remote Control will be linked to the External Trial Stimulator immediately.

External Trial Stimulator

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Vercise™ DBS Programming Manual

De‑linking a Remote Control from a Stimulator To de‑link a Remote Control from a Stimulator: 1 Press and hold the P button to unlock the Remote Control. 2 Enter the Clinician’s screen on the Remote Control by pressing and holding both the simultaneously.

and P buttons

3 Scroll down to “Clear Link” and select “Clear Link” by pressing the P button. 4 Confirm that you want to clear the link by pressing the P button or cancel by pressing the

button.

5 Enter the password A‑B‑C. Note: To re‑link the Remote Control, see the “Linking a Remote Control to a Stimulator” section of this manual.

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Starting a Session

Starting a Session

Getting to the Start Screen The Start Screen will open when the Bionic Navigator Software launches. To access the Start Screen at any other time, click from the top right corner of any screen.

If patient’s Remote Control is connected and positioned to communicate with the Stimulator, the system will automatically detect the DBS Stimulator.

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Vercise™ DBS Programming Manual

Understanding the Toolbar The toolbar is present at the top of every screen in the Bionic Navigator software. The toolbar allows you to access various features defined in the table below and further described in several sections of this guide. Click…

to… Create reports, including patient information reports, generic reports, patient list reports, clinical outcomes reports, and clinic activity reports. Synchronize data between the Clinician Programmer and a Patient Card (for data transfer). To access various tools, including system information, backing up data, enabling auto‑impedance measurements, EGL‑Scan, and viewing information about Bionic Navigator. View and edit default system settings. To end your current session and restart Bionic Navigator.

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Starting a Session

Understanding the Common Buttons Common buttons are dispersed around the perimeter of each screen in the Bionic Navigator software. These buttons allow you to quickly and conveniently access common screens or perform common actions. The function of these buttons are defined in the table below and further described in several sections of this guide. Click…

to… Access the Profile screen. Access the Configuration screen. Turn stimulation on (applies to all areas with Amplitude set at a value greater than zero). Turn stimulation off.

Access the Programming screen.

Access the Remote Control screen.

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Vercise™ DBS Programming Manual

Starting a New Patient Session The Bionic Navigator software automatically starts a new session when it is opened. When the software is already open, you may start a new session or restart the Bionic Navigator software using the Start function. To use the Start function, click

on the toolbar of any screen.

Creating a New Patient To create a new patient: 1 Click the down arrow on the right side of the Patient drop‑down menu. 2 Select New Patient. The Profile Screen will automatically be displayed. 3 Fill in the patient’s information.  or more information on the Profile Screen, see the “Managing a Patient’s Profile” section of this F manual. 4 Click

to save the information.

The Start Screen will automatically be displayed. 5 Click the down arrow on the right side of the Reason for Visit drop‑down menu. 6 Select the appropriate reason for the visit.

Selecting an Existing Patient The Clinician Programmer will automatically recognize a patient if you have previously link the Clinician Programmer to the patient’s hardware. To select an existing patient: 1 Click the down arrow on the right side of the Patient pull‑down menu. 2 Select an appropriate patient from the alphabetized list. 3 Click the down arrow on the right side of the Reason for Visit pull‑down menu. 4 Select the reason for the patient visit. The patient session has now begun. You may now proceed to other screens by clicking the appropriate buttons on the screen.

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Managing a Patient’s Profile

Managing a Patient’s Profile

Entering and Editing Patient Information To create or edit a patient’s profile: 1 Click

in the upper right corner of any screen.

If a patient is currently selected, the patient’s information will show up on the Profile Screen. Note:  If no patient was selected, it is assumed that you wish to create a new patient and the fields on the Profile Screen will be empty. To select or create a patient, see the “Starting a Session” section of this manual. 2 Enter the following information. Required fields are denoted by bold text. ● First Name ● Last Name ● Birth Date ● Patient ID ● Gender: Male or Female ● Physician ● Diagnosis ● Patient Address ● Patient Phone Number Note:  Though not required, it is preferred that you also enter information in the Patient ID and Physician fields. 3 Click You may click

to save the information. to reverse any unsaved changes or entries.

Note: In the event that any button other than will automatically be saved.

is selected, the patient information entered

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Vercise™ DBS Programming Manual

Entering Patient Notes

The Notes screen is used to enter information relevant to the patient and/or the programming session. The information entered is stored and can be chronologically viewed in the patient’s case history. To enter notes: 1 If you are not currently in the Profile Screen, click 2 Click

in the upper right corner of any screen.

towards the bottom of the Profile Screen.

3 Click the main entry field of the Notes window. Current notes are editable, but past notes are read‑only and can be viewed in the case history. 4 Enter text. 5 Click

to save the information or

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to cancel the changes and return to the Profile Screen.

Managing a Patient’s Profile

Viewing a Patient’s Case History

Case History displays chronologically dated patient file information, including the visit history and notes. Each visit is time stamped and displayed along with the Reason for Visit and Notes. Note: Patient visits are recorded and time stamped only when the user exits or saves the Profile Screen. To view a patient’s Case History: 1 If you are not currently in the Profile Screen, click 2 Click

towards the bottom of the Profile Screen.

3 To exit, click

.

in the upper right corner of any screen.

Case History is read‑only. To enter new Notes, see the “Entering Patient Notes” section of this manual. To print a patient’s Case History, see the “Creating Reports” section of this manual.

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Vercise™ DBS Programming Manual

Configuring the Vercise DBS System Verifying the Vercise DBS System Configuration

The Configuration (or Config) screen displays information about the system components. The Stimulator and Remote Control product and serial numbers are automatically detected and recorded. The Lead information is also displayed. Note: The Configuration screen may only be accessed once a patient is selected. To verify the Vercise DBS System configuration: 1 Click

in the upper right‑hand corner of any screen.

If Lead information has not been entered, the information will be requested before the Configuration screen is displayed. 2 Verify that the Lead information is correct. 3 Verify that the Stimulator model and serial number are correct. 4 Verify that the Remote Control model and serial number are correct. 5 Verify that the electrode labels correctly correspond to the left and right Leads (in the image of the Leads to the right of the screen). By default, Bionic Navigator assigns contacts 1 through 8 to the left Lead and contacts 9 through 16 to the right Lead. If the contacts do not correspond correctly, see the “Swapping the Leads” section of this manual.

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