Boston Scientific VERCISE DBS Owner's manual

91053785-17
Content: 92427678 REV A
Vercise™ DBS
Programming Manual
Directions for Use
en
Directions for Use
Instrucciones de uso
Mode d’emploi
Gebrauchsanweisung
Istruzioni per l’uso
Gebruiksaanwijzing
Bruksanvisning
Käyttöohje
Bruksanvisning
Brugsanvisning
Instruções de Utilização
Instruções de uso
Kullanım Talimatları
Указания по использованию
Οδηγίες χρήσης
Návod k použití
Návod na použitie
Instrukcja obsługi
Használati útmutató
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How to Use this Manual
This manual describes the installation of the Boston Scientic Bionic Navigator software. Read
all instructions carefully before using the DBS Systems.
For indications for use, contraindications, warnings, precautions, adverse events, sterilization,
component disposal, storage and handling, and warranty information, refer to the Physician
Manual for your Boston Scientic DBS System as listed in your DBS Reference Guide. For
other device‑specic information not included in this manual or labeling symbols, refer to the
appropriate DFU for your Boston Scientic DBS System as listed in your DBS Reference Guide.
Guarantees
Boston Scientic 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.
Contacting Boston Scientic
To contact Boston Scientic, refer to the “Technical Support” section of this manual.
Product Model Numbers
Model Number Description
DB‑1110‑C Vercise IPG Kit
DB‑5110‑C Vercise ETS
DB‑5212‑C Vercise Remote Control
DB‑5500‑C Vercise Remote Control Kit
*DB‑7164 and NM‑7164 VerciseTM DBS Clinician Programmer
*DB‑7164‑R and NM‑7164‑R VerciseTM DBS Clinician Programmer (Refurbished)
NM‑7165 Keyboard
NM‑7171 CP Charger
NM‑4500 IR Interface
NM‑4502 IR Interface Holder
DB‑4511 and NM‑4511 USB Serial Cable
NM‑4512 USB Splitter
DB‑7101‑203‑W10 Bionic Navigator 2.03 (Win 10) Installer
*Applicable after installation of Bionic Navigator 2.03 (Software version 9028287‑203)

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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 ................................................................................................11
Selecting an Existing Patient .......................................................................................12
Managing a Patient’s Prole...........................................................................................13
Entering and Editing Patient Information ...................................................................13
Entering Patient Notes .................................................................................................14
Viewing a Patient’s Case History ................................................................................15
Conguring the Vercise DBS System .............................................................................16
Verifying the Vercise DBS System Conguration ......................................................16
Modifying the Lead Information .................................................................................17
Swapping the Leads ....................................................................................................18
Testing Impedances .....................................................................................................19
Programming the Patient................................................................................................20
Stimulator Programmable Characteristics ...................................................................20
Getting to the Programming Screen ............................................................................21
Selecting an Area .........................................................................................................22
Selecting Contacts .......................................................................................................23
Turning Stimulation On and Off for Individual Areas ................................................25
Increasing and Decreasing the Amplitude ...................................................................26
Increasing and Decreasing the Pulse Width ................................................................27
Increasing and Decreasing the Rate ............................................................................28
Programming Multiple Areas ......................................................................................29
Dening the Amplitude Range ....................................................................................31
Understanding the Charge Density Warnings .............................................................33
Naming the Areas ........................................................................................................34
Naming the Program ...................................................................................................35
Globally Turning Stimulation Off and On ..................................................................36
Adjusting Patient Options ...........................................................................................37
Managing Programs ........................................................................................................40
Getting to the Remote Screen ......................................................................................40
Understanding the Program Slots ................................................................................41
Saving a Program ........................................................................................................42
Activating a Program from the Remote Control Panel ...............................................43

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Previewing a Program from the Remote Control Panel ..............................................44
Deleting a Program ......................................................................................................45
Checking the Stimulator Battery Status and Viewing the Estimated Charging Time .46
Managing Programs in the Program Database.............................................................47
Viewing Programs in the Program Database ...............................................................47
Activating a Program from the Program Database .....................................................48
Previewing a Program from the Program Database ....................................................49
Deleting a Program from the Program Database ........................................................50
Creating Reports..............................................................................................................51
Choosing a Report .......................................................................................................51
Patient Information Report ..........................................................................................52
Generic Report ............................................................................................................53
Patient List Report .......................................................................................................54
Clinical Outcomes Report ...........................................................................................55
Clinical Activity Report ..............................................................................................56
Synchronizing Data..........................................................................................................57
Understanding the Synchronizing Data function ........................................................57
Installing a New Patient Card ......................................................................................58
Synchronizing Data ....................................................................................................59
Deleting Patient Records .............................................................................................60
Using Additional Tools.....................................................................................................61
Viewing System Information ......................................................................................61
Backing Up Data and Logs .......................................................................................62
Measuring Field Potentials ..........................................................................................63
Adding a Lead .............................................................................................................64
Enabling and Disabling Auto Impedance ....................................................................65
Viewing Information about Bionic Navigator .............................................................66
Clinician Programmer Management .............................................................................67
Adjusting CP Date and Time .......................................................................................67
Resetting ClinicUser Password ...................................................................................68
Software Installation, Uninstallation, and Removal ....................................................70
Managing System Settings ..............................................................................................71
Viewing the System Settings .......................................................................................71
Adjusting the Default Pulse Width ..............................................................................72
Adjusting the Default Rate ..........................................................................................73
Adjusting the Default Ramp Time ..............................................................................74
Selecting the Default Remote Control Language ........................................................75
Setting the Patient Name Display Preference .............................................................76
Addendum ........................................................................................................................77
Technical Support ............................................................................................................78

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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 conguring 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 specic 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).

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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 Scientic.
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 benets 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 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 equipment for the patient environment as dened by
IEC60601‑1. The CP and the person using the CP should not be in
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 rst login, use “bsn” as a temporary password.
You will be prompted to setup a new ClinicUser password when logging into the
CP for the rst 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‑specic
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 2 3

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Setting Up
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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 and select the Vercise DBS System icon to start Bionic Navigator.
Note: Multiple programming softwares 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 and P buttons simultaneously.
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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Linking a Remote Control to a Stimulator
Linking is dened as the process of conguring the Remote Control to communicate with
a specic Stimulator.
To link a Remote Control that has been previously linked to a different Stimulator, you
must rst 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 button.
4 Conrm the link by pressing the P button or cancel by pressing the button.
If programs are
stored in the… Then…
Remote Control
Stimulator
The Remote Control will automatically download the
programs from the Stimulator.
Remote Control
Stimulator
The Remote Control will automatically download the
programs from the Stimulator.
Remote Control
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.
Remote Control
Stimulator
The Remote Control will be linked to the Stimulator
immediately.

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If programs are
stored in the… Then…
Remote Control
External Trial
Stimulator
The Remote Control will prompt you to clear the programs
on the 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
The Remote Control will prompt you to clear the programs
on the External Trial Stimulator.
Remote Control
External Trial
Stimulator
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
The Remote Control will be linked to the External Trial
Stimulator immediately.

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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 and P buttons simultaneously.
3 Scroll down to “Clear Link” and select “Clear Link” by pressing the P button.
4 Conrm that you want to clear the link by pressing the Pbutton 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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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 dened 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
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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 dened in
the table below and further described in several sections of this guide.
Click… to…
Access the Prole screen.
Access the Conguration 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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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.

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Starting a Session
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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 Prole Screen will automatically be displayed.
3 Fill in the patient’s information.
For more information on the Prole Screen, see the “Managing a Patient’s
Prole” section of this 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.

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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 Prole
Managing a Patient’s Prole
Entering and Editing Patient Information
To create or edit a patient’s prole:
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
Prole Screen.
Note: If no patient was selected, it is assumed that you wish to create a new
patient and the elds on the Prole 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 elds 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 elds.
3 Click to save the information.
You may click to reverse any unsaved changes or entries.
Note: In the event that any button other than is selected, the patient
information entered will automatically be saved.

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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 Prole Screen, click in the upper right
corner of any screen.
2 Click towards the bottom of the Prole Screen.
3 Click the main entry eld 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 to cancel the changes and return
to the Prole Screen.