Boston Scientific DB-1110-C Manual

91053785-09 REV A
Directions for Use
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Gebrauchsanweisung
Gebruiksaanwijzing
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Vercise™ DBS
Programming Manual
Directions for Use

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Trademark
All trademarks are the property of their respective holders.
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.
Additional Information
For indications, contraindications, warnings, precautions, adverse events summary, sterilization,
component disposal, storage and handling, warranty information and other device specic
information not included in this manual, refer to the Vercise Physician Manual. For labeling
symbols, refer to the Labeling Symbols Directions for Use.
Product Model Numbers
Model Number Description
DB-1110-C Vercise IPG Kit
DB-4511 Cable, USB Serial
DB-5110-C Vercise ETS
DB-5212-C Vercise Remote Control
DB-5500-C Vercise Remote Control Kit
*DB-7161 Clinician Programmer
*DB-7161-R Clinician Programmer (Refurbished)
DB-7161-203 Clinician Programmer
DB-7161-203-R Clinician Programmer (Refurbished)
*NM-7161 Clinician Programmer
*NM-7161-R Clinician Programmer (Refurbished)
NM-4500 IR Interface
NM-4502 IR Interface Holder
NM-4512 USB Splitter
*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
Previewing a Program from the Remote Control Panel....................................................... 44

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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
Adjusting CP Time and Date................................................................................................ 67
Managing System Settings........................................................................................................... 68
Viewing the System Settings............................................................................................... 68
Adjusting the Default Pulse Width ....................................................................................... 69
Adjusting the Default Rate................................................................................................... 70
Adjusting the Default Ramp Time........................................................................................ 71
Selecting the Default Remote Control Language ................................................................ 72
Setting the Patient Name Display Preference ..................................................................... 73
Addendum...................................................................................................................................... 74
Troubleshooting ............................................................................................................................ 75

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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 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 Troubleshooting section.
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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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 IEC 60601-1.
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 Plug the USB to Serial Cable into the USB port on the Clinician Programmer.
2 Plug the serial end of the USB to Serial Cable into the matching end of the IR Interface.
3 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
4 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.
5 Turn on the Clinician Programmer and log in.
6 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.
7 Press and hold the P button to unlock the Remote Control.
Note: The Remote Control should be linked to the Stimulator (see Linking a Remote
Control to a Stimulator on page 4).
8 Enter the Clinician’s screen on the Remote Control by pressing and holding both the and
Pbuttons simultaneously.
9 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 De-linking a Remote Control from a
Stimulator on page 6) 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 Pbutton 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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Setting Up
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
Pbuttons simultaneously.
3 Scroll down to “Clear Link” and select “Clear Link” by pressing the Pbutton.
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 Linking a Remote Control to a Stimulator
on page 4.

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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
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
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 Managing a Patient’s Prole on page 13.
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
Starting a Session on page 7.
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.