Boston Scientific Vercise Neural Navigator 4 Owner's manual

92441271-03
Content: MP92441271-03 REV B
Vercise™
Neural Navigator 4
Programming Manual
Directions for Use
Directions for Use
Mode d’emploi
Gebrauchsanweisung
Gebruiksaanwijzing
Instrucciones de uso
Istruzioni per l’uso
Instruções de Utilização
Οδηγίες χρήσης
Bruksanvisning
Brugsanvisning
Käyttöohje
Bruksanvisning
Návod k použití
Návod na použitie
Használati utasítások
Instrukcja obsługi
Указания за употреба
Upute za upotrebu
Instrucțiuni de utilizare
Navodila za uporabo
en fr de nl es it pt-EU el no da sv cs sk hu pl bg hr ro sl

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How to Use This Manual
This manual describes the usage of the Boston Scientic Vercise Neural 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 Information for Prescribers DFU 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.
Trademarks
All trademarks are the property of their respective holders.
The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Boston
Scientic Neuromodulation Corporation is under license.
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-7164 and NM-7164 Vercise™ DBS Clinician Programmer
*DB‑7164‑R and NM‑7164‑R Vercise™ DBS Clinician Programmer (Refurbished)
NM-7165 Keyboard
NM-7171 Power Supply for Tablet Computer
DB-7190 and NM-7190 Programming Wand
NM-4512 USB Splitter
NM-6316 International Power Converter
DB-5270 Vercise DBS Remote Control 4
DB-6386 DBS Pairing Magnet
**DB-7105-N4A Vercise Neural Navigator Software 4.0 Installer
*Applicable after installation of Vercise Neural Navigator 4.0 (Software version 9028429‑400).
** Both software part 9028429‑400 and 9028602‑100 must be installed prior to use.

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Table of Contents
Introduction.....................................................................................................................................................1
Intended Use ............................................................................................................................................................................ 1
Setting Up ................................................................................................................................................................................. 2
Placing the Implanted Stimulator into CP Mode (Pairing Mode) (Vercise Genus Stimulators Only) .........................................................3
Placing ETS 3 into CP Mode (Pairing Mode) .............................................................................................................................................4
Connecting the Programming Wand to the CP (Vercise Gevia, Vercise PC, and ETS 2 Stimulators Only) ..............................................4
Starting a Programming Session..................................................................................................................5
Starting Vercise Neural Navigator ............................................................................................................................................. 5
Programming the Stimulator.........................................................................................................................8
Conguring the Leads ............................................................................................................................................................... 8
Measuring Impedances .............................................................................................................................................................................9
The Programming Screen ......................................................................................................................................................... 10
Creating or Modifying a Program .............................................................................................................................................. 13
Selecting Stimulation Areas ...................................................................................................................................................... 13
Selecting Contacts .................................................................................................................................................................... 13
Steering Mode ...........................................................................................................................................................................................14
Custom Mode ............................................................................................................................................................................................15
Turning Stimulation OFF for Individual Areas ........................................................................................................................... 15
Turning All Stimulation OFF ...................................................................................................................................................... 15
Increasing and Decreasing the Amplitude ................................................................................................................................ 15
Increasing and Decreasing the Pulse Width ............................................................................................................................. 16
Increasing and Decreasing the Rate......................................................................................................................................... 16
Programming Multiple Areas with Different Rates .....................................................................................................................................16
Selecting Patient Amplitude Range........................................................................................................................................... 16
Viewing the Stimulation Field Model ......................................................................................................................................... 17
Mapping the Patient’s Clinical Effects of Stimulation ................................................................................................................ 18
Ending a Programming Session ............................................................................................................................................... 19
Magnet Pairing .......................................................................................................................................................................... 19
Data..................................................................................................................................................................20
Export Database ....................................................................................................................................................................... 21
Tools ................................................................................................................................................................22
Updates .................................................................................................................................................................................... 22
Deleting Clinical Effects Data .................................................................................................................................................... 23
Deleting Patient Data ................................................................................................................................................................ 23
Additional Information ...................................................................................................................................24
Stimulator Programmable Characteristics ................................................................................................................................ 24
Charge Density ......................................................................................................................................................................... 25
Energy Use Index ..................................................................................................................................................................... 26
Vercise Genus P8, P16, and P32 Non‑Rechargeable Stimulators ............................................................................................................26
Vercise PC Non‑Rechargeable Stimulator.................................................................................................................................................26
Estimated Charge Time ............................................................................................................................................................ 27
Elective Replacement Indicator (ERI) Message ....................................................................................................................... 27
End of Service (EOS) Message ................................................................................................................................................ 27
Clinician Programmer Management .............................................................................................................28
Adjusting CP Date and Time ..................................................................................................................................................... 28
Resetting ClinicUser Password................................................................................................................................................. 28
Update Password ......................................................................................................................................................................................28
Lost/Forgotten Password ...........................................................................................................................................................................29
Software Installation, Uninstallation, and Removal ................................................................................................................... 29

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Software Licenses..........................................................................................................................................30
Security.Cryptography ............................................................................................................................................................... 30
HIDSharp .................................................................................................................................................................................. 30
Newtonsoft Json.NET ............................................................................................................................................................... 32
SharpDX ................................................................................................................................................................................... 32
vNext ......................................................................................................................................................................................... 32
Technical Support ..........................................................................................................................................33

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Introduction
The Boston Scientic Vercise™ Neural Navigator software is used to program the Vercise™ PC, Vercise Gevia™, and Vercise Genus™ Deep
Brain Stimulation (DBS) Systems.
A programming session may include the following activities:
1. Setting Up
2. Starting Vercise Neural Navigator
3. Connecting to the Stimulator
4. Conguring the Stimulator and Leads
5. Testing different Stimulation Settings
This manual will provide instructions on how to accomplish these steps and perform additional functions, such as exporting reports and backing
up data.
Boston Scientic DBS Systems utilize MICC1 technology which is designed to adapt for impedance changes and maintain consistent therapy
over time. MICC technology enables current steering across Lead Contacts which is intended to provide precise positioning of stimulation.
If you have any issues, contact Boston Scientic Technical Support.
Note: Screens depicted in this manual may differ slightly from the screens on your Vercise Neural Navigator.
Intended Use
Vercise Neural Navigator is a software program that is used to set and adjust stimulation parameters for the Vercise PC, Vercise Gevia, and
Vercise Genus DBS Systems.
1 Multiple independent current control

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Setting Up
The Clinician Programmer (CP) communicates with the Stimulator via wireless telemetry. Wireless Programming allows patients to move about,
if instructed by the clinician, while the clinician adjusts parameters. Vercise Genus devices utilize Bluetooth technology for direct wireless
communication between the CP and the Stimulator. Vercise PC and Vercise Gevia devices communicate via a Programming Wand. The
Programming Wand uses an inductive telemetry radiofrequency (RF) link to communicate with the Stimulator.
Caution: Use only Vercise PC, Vercise Gevia, or Vercise Genus DBS System components with Vercise Neural Navigator. Failure to do so
may result in the inability to program the Stimulator.
Caution: The CP is not considered as equipment for the patient environment as dened by IEC 60601‑1. The CP and the person using the
CP should not be in physical contact with the patient while programming.
1. Plug the CP into a power source.
2. Power ON the CP.
3. Login as ClinicUser. If this is the rst login, enter password “bsn”. 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 ClinicUser password.
4. Determine the type of Stimulator to be programmed and follow the appropriate sections as listed in Table 1, then continue on to the
“Starting a Programming Session” section of this manual.
Table 1: Stimulator Programming Setup Reference Table
Stimulator Type Model Numbers Reference Section
Vercise Genus IPG(s)
DB-1408, DB-1416,
DB-1432, DB-1216,
DB-1232
See “Placing the Implanted Stimulator into CP Mode (Pairing Mode) (Vercise Genus
Stimulators Only)” on page 3 of this manual.
ETS 3 DB-5170 See “Placing ETS 3 into CP Mode (Pairing Mode)” on page 4 of this manual.
Vercise Gevia IPG DB-1200 See “Connecting the Programming Wand to the CP (Vercise Gevia, Vercise PC, and
ETS 2 Stimulators Only)” on page 4 of this manual.
Vercise PC IPG DB-1140 See “Connecting the Programming Wand to the CP (Vercise Gevia, Vercise PC, and
ETS 2 Stimulators Only)” on page 4 of this manual.
ETS 2 DB-5132 See “Connecting the Programming Wand to the CP (Vercise Gevia, Vercise PC, and
ETS 2 Stimulators Only)” on page 4 of this manual.

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Placing the Implanted Stimulator into CP Mode (Pairing Mode) (Vercise Genus Stimulators Only)
1. Use the patient’s Remote Control to enter the Stimulator into CP Mode (Pairing Mode). The Remote Control and Stimulator must be
linked in order to place the Stimulator into CP Mode (Pairing Mode).
(a). From the Lock screen, press and hold the button until the screen displays “Stimulator Ready for CP Connection” (Figure 1 and
Figure 2).
Figure 1. Programs Button on Remote Control Figure 2. Stimulator Ready for CP Connection
(b). Alternatively, navigate to the Clinician Menu on the patient Remote Control and select CP Mode: Stimulator (Figure 3).
Figure 3. CP Mode: Stimulator
Note: If the Stimulator does not have a linked Remote Control, refer to the appropriate Remote Control manual as listed in your
DBS Reference Guide for instructions on Stimulator Linking.
Note: If the linked Remote Control is not available, see the “Magnet Pairing” section of this manual.
Note: The Stimulator will automatically exit CP Mode (Pairing Mode) after two minutes if a CP connection is not established.

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Placing ETS 3 into CP Mode (Pairing Mode)
1. Press and hold the Stimulation Button on the side of the ETS until the lights ash (Figure 4). The ETS battery indicator light will
alternate blinking green and yellow, indicating that the ETS is in CP Mode (Pairing Mode) and is available for connection.
Note: The Stimulator will automatically exit CP Mode (Pairing Mode) after two minutes if a CP connection is not established.
Figure 4. ETS Battery Indicator Light
Connecting the Programming Wand to the CP (Vercise Gevia, Vercise PC, and ETS 2 Stimulators Only)
1. Connect the Programming Wand to the CP using the USB cable provided with the Programming Wand (Figure 5).
(a). Plug the Mini USB end of the USB Cable into the USB Port on the side of the Programming Wand.
(b). Plug the Standard USB end of the USB Cable into the USB Port on the CP.
Figure 5. Vercise PC and Vercise Gevia: Clinician Programmer (CP) and Programming Wand
2. Wait for the Wand to perform a self‑test. At the end of the self‑test, the Wand will beep.
3. If the Power Light on the Wand is green, place the Wand over the Stimulator.
(a). If the Power Light on the Wand remains red, contact Technical Support.
Note: Be sure to connect the Programming Wand to the CP prior to launching Vercise Neural Navigator.

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Starting a Programming Session
Starting Vercise Neural Navigator
1. Select the Vercise Launcher icon on the desktop.
2. Select to start Vercise Neural Navigator.
Note: If Brainlab Elements is present on the CP, Vercise Neural Navigator may be launched from within Elements .
Note: Multiple software should not be run simultaneously on the same CP (except when launching Vercise Neural Navigator from within
Elements).
Note: Vercise Neural Navigator can also be launched in Demo Mode using the Vercise Launcher. Demo Mode is used for
demonstration purposes only (Figure 6).
Figure 6. Launch Screen with DEMO Option Mode

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3. Upon starting Vercise Neural Navigator, the screen will show the Connect Tab and the software will automatically search for a Stimulator
to connect to (Figure 7 and Figure 8).
(a). Vercise Genus: A Stimulator that is in CP Mode (Pairing Mode) and is within range will automatically appear on the Connect
Tab (Figure 7). If no Stimulator is found and displayed on the Connect Tab, conrm that the Stimulator is in range and is in
CP Mode (Pairing Mode) by viewing the Patient Remote Control Screen. Select the Refresh button on the CP (Figure 7).
Note: A Vercise Genus Stimulator must be in CP Mode (Pairing Mode) in order to establish a connection with the CP.
Figure 7. Vercise Genus Connect Tab
(b). Vercise PC and Vercise Gevia: The Connect Tab will show the Programming Wand (Figure 8). Press the Scan button. The CP will
then scan for devices using the Programming Wand. If only one Stimulator is found in range, the CP will automatically connect to that
Stimulator. If no Stimulator is found, move the Wand closer to the Stimulator that you are trying to connect to and select the Scan
button.
Note: Be sure to connect the Programming Wand to the CP prior to launching Vercise Neural Navigator.
Figure 8. Vercise PC and Vercise Gevia Connect Tab
Note: The CP cannot connect to a Stimulator when the Stimulator is in MRI Mode. Exit MRI Mode using the Remote Control and
Refresh to connect. For instructions on exiting MRI Mode, refer to the Remote Control Manual as listed in your DBS Reference
Guide.
Table 2: Vercise Neural Navigator Tab Descriptions
# Feature Description
1Connect Tab Displays the connection status between the CP and Stimulator.
2Congure Tab Congure Leads and edit patient prole.
Note: If Brainlab Elements is present on the CP, some patient data may be imported from Elements.
3Program Tab Adjust the Stimulator program settings.
4Data Tab Generate, print and export reports, and export or delete selected patient(s) data.
5Tools Tab Manage data and updates.
6End Session Tab Disconnect from the Stimulator or exit the application.
7Battery Indicator Displays the battery status of the CP.

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4. Press the Connect button next to the Stimulator.
5. Once a connection has been established between the CP and the Stimulator, the following screen will appear (Figure 9 and Figure 10).
Figure 9. Connection Established Between CP and Stimulator (Vercise Genus or ETS 3)
Figure 10. Connection Established Between CP and Stimulator (Vercise Gevia, Vercise PC, or ETS 2)
Table 3: Description of the Connect Tab
# Feature Description
1Patient ID Displays the Patient ID number.
2Connection Status
Displays the connection status between the CP and Stimulator along with the Model and Serial Number of each
of the devices.
#Connection Status Description
1Connection between CP and Vercise Genus or ETS 3 Stimulator
was established.
2Connection between CP, Programming Wand, and Vercise Gevia,
Vercise PC, or ETS 2 Stimulator was established.
3
Connection not established. Ensure the Vercise Genus or ETS 3
Stimulator is in CP Mode (Pairing Mode). For Vercise Gevia or
Vercise PC, move the Programming Wand closer to the Stimulator
and Scan again, and/or see the “Connecting the Programming
Wand to the CP (Vercise Gevia, Vercise PC, and ETS 2 Stimulators
Only)” section of this manual or refer to the Vercise DBS
Programming Wand Manual for more information.
3Refresh Button Scan for available Stimulators. Disabled if the CP is already connected to the Stimulator.
4Connection Status Displays a green or blue lled circle if the Stimulator is connected to the CP.
5Connect or
Disconnect Button
Connect or disconnect from a Stimulator. When a Stimulator is not connected, this button reads “Connect.”
When a Stimulator is connected, this button reads “Disconnect.”
6 Signal Strength Displays the signal strength for communication between the CP and Stimulator (Vercise Genus or ETS 3 only).

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Programming the Stimulator
Conguring the Leads
Once a connection has been established between the CP and Stimulator, switch to the Congure Tab to congure the Leads that are
connected to the Stimulator (Figure 11 and Figure 12). During an initial programming session, Lead Conguration must be completed prior to
navigating to the Program Tab.
Note: Once a Stimulator has been initially congured, you can directly switch to the Program Tab after connection has been established from
the Connect Tab.
Note: If Brainlab Elements is available on the CP, you may import Lead information and objects into the Neural Navigator software
from Elements. To import or remove Elements data, Link or Unlink from the Congure screen. This option will only be available if
Neural Navigator is launched from within Elements.
Figure 11. Conguring a 16 Contact Stimulator
During the implantation procedure of a 32 Contact (4 Port) Stimulator, no more than two Leads should be connected to the Stimulator.
Therefore, only two of the four ports are to be congured for programming. Only Ports L2 and R2 of the 32 Contact IPG are available for
programming.
Figure 12. Conguring a 32 Contact Stimulator

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Table 4: Description of the Congure Tab
# Feature Description
1Leads Conguration
For each Lead, select the Lead type, Stimulator Port to which the Lead is connected, and brain hemisphere.
Enter the target Area. For Directional Leads, select the Directional Marker orientation.
Note: When Lead information has been imported from Elements, changes made in the Congure Tab rather
than in Elements may cause the Stimulator to be unlinked from Elements.
2 Measure Button Measure Impedances. See the “Measuring Impedances” section of this manual for more information.
3Link/ Relink/ Unlink
Patient
Import or remove data from Elements.
Note: This is only available if Brainlab Elements is installed on the CP and Neural Navigator is launched from
within Elements.
4Patient Amplitude
Control Turn ON/OFF the patient’s ability to change stimulation Amplitude. The range of Patient Amplitude Control is adjusted in the Program Tab.
5Stimulator Information Displays the Stimulator Information including Serial number, Model number, Firmware Version and type of
Stimulator.
6Implant Date Displays the date on which a CP rst connects to a new Stimulator. The Implant Date can be adjusted by
selecting the Implant Date button.
7Patient ID The Patient ID automatically defaults to the Stimulator serial number. The Patient ID can be edited by typing into
the Patient ID eld.
Measuring Impedances
Impedances can be measured using the Measure button on the Congure or Program Tabs. The impedances of each Contact may be used to
verify electrical integrity. When an impedance measurement is taken, impedances are assessed between a Contact and the Stimulator Case
(monopolar), and between pairs of Contacts (bipolar). Impedances over 8000 Ω may be the result of open or unconnected wires and are
displayed in yellow on the Impedance Measurement window. Impedances less than 200 Ω may be the result of short circuits and are displayed
in orange. Contacts that have impedances outside the acceptable range are marked with a symbol on the programming screen. The most
recent set of impedance measurements are included in a report that can be printed or exported from the Data Tab.

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The Programming Screen
Once the Leads have been congured, select the Program Tab to begin programming. The Programming screen is divided into the following
sections and features as shown in Figure 13. Programming features specic to the Directional Lead and Programming a Directional System
are shown in Figure 14. The Clinical Effects Map is shown in Figure 13 and can be viewed for both a Standard Lead and Directional Lead.
STIMVIEW™, or the Stimulation Field Model (SFM), is shown in Figure 14 and can be viewed for both a Standard Lead and a Directional Lead.
Figure 13. Programming Screen
Figure 14. Directional Lead Programming Screen

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Table 5: Description of the Program Tab
# Feature Description
1 Program Button Select the Program that you would like to set up or adjust.
2Program Options
Button
• View Energy Use Index for non‑rechargeable Stimulators.
• View battery recharge estimate for rechargeable Stimulators.
• Delete and copy Programs.
• Change ramp and cycle times for Programs.
3 Area Panel Select the Area within a Program that you would like to set up or adjust.
4Area Options Button Delete an Area within a Program or import simulations from Brainlab Elements (if Elements is present on the
CP).
5+Add an Area. Select from one of the Stimulator Ports dened in the Congure Tab.
6Stimulation ON/OFF
Button
Turn stimulation OFF for the Area selected.
Note: When the Amplitude is at 0 mA, increase the Amplitude to turn ON stimulation.
7 Pulse Width Button
Adjust the Pulse Width.
Default Range
60 μS 20 μS to 450 μS
8Rate Button
Adjust the Rate.
Default Range
130 Hz 2 Hz to 255 Hz
9Units Button
Select the Units in which Amplitude is displayed on Contacts and Stimulator Case.
Default Alternative
% mA
10 Patient Amplitude
Buttons
Adjust Maximum and Minimum Patient Amplitude.
Note: The Patient Amplitude buttons are only displayed if the Patient Amplitude Control has been set to ON
from the Congure Tab.
11 Stop All Button Turns off all stimulation.
12
Contact and
Stimulator Case
Conguration
Displays percentage of anodic (+) or cathodic (‑) energy assigned to the Lead Contacts and Stimulator Case for
a given Area. See the “Selecting Contacts” section of this manual for more information.
13 Measure Button Measures impedances of the Contacts.
14 Programming Modes Select Steering or Custom Programming modes.
15 Step Size Select the step size for Amplitude adjustments: 0.1 mA or 0.5 mA.
16 Level Up and Down
Buttons Steer stimulation focus along the Lead. Press the Level number to select a new Level.
17 Total Amplitude Increase or decrease the total Amplitude delivered for a given Area.
18 Clinical Effects Panel Make note of the Therapeutic Benets and/or Side Effects for the current Stimulation settings.
19 Text Notes Capture text notes for a given Lead (up to 250 characters per Area).
20 Clinical Effects Map
Graphical summary of assigned Therapeutic Benets and/or Side Effects at a given position along the DBS
Lead array and a stimulation Amplitude.
Note: Clinical effects data is captured and listed in reports but not plotted on the Clinical Effects Map for
congurations not possible in Steering Mode and for Directional Lead settings that are not 100%
focused or spread.
21 Display Drop‑down View control to switch between the Clinical Effects Map, 3D Overview, or 3D Split View of the stimulation eld.
22 Reference Head The reference head demonstrates the relationship of the Lead currently being programmed to the position of the
patient head.
23 Clinical Effects
Legend The level of therapeutic benet is indicated by the saturation of the dot.

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Table 5: Description of the Program Tab
# Feature Description
24
STIMVIEW™ or
Stimulation Field
Model (SFM)
Visual representation of the estimated stimulation eld for the currently programmed stimulation parameters.
Note: If Brainlab Elements is available on the CP, imported objects may be viewed in STIMVIEW, referred to
as STIMVIEW XT when imported objects are displayed.
25 Directional Presets
Select the one touch buttons to adjust the stimulation eld. The directional presets will steer the fully focused
stimulation eld in one of four orthogonal directions or put the stimulation eld into “ring mode.” Ring Mode
generates, from a segmented Contact Level, stimulation elds equivalent to those generated by a standard
“ring” or cylindrical Contact.
Note: Only applies to Directional Leads.
26 Rotate Buttons Steer the stimulation focus circumferentially around the Lead.
Note: Only applies to Directional Leads.
27 Spread/Focus Buttons Radially spread or focus the stimulation eld.
Note: Only applies to Directional Leads.
28 Directional Indicator
Visual indicator of the orientation of the radiopaque Directional Marker band on the Directional Lead. The
orange line and dot correlate to the center of the radiopaque Directional Marker.
Note: Only applies to Directional Leads.
29 STIMVIEW™ View
Controls
Adjust the view of the SFM using Zoom, Rotate, Panning Control, or Reset to the original view. Both the
Lateral and Axial views of the SFM will adjust in unison using these controls when in 3D Split View, but must be
adjusted in the Lateral view.
30 Virtual Contact Dotted ring illustrating the axial location of stimulation along the Lead. The arrow indicator illustrates the rotational orientation of stimulation around the Lead. The dotted ring and arrow indicator together form the
Virtual Contact.

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Creating or Modifying a Program
To create a new Program or modify an existing Program, select the Program button and choose one of the four Programs from the drop‑down
arrow. The system allows you to congure up to four Programs on a Stimulator.
For a given Program, you can view and/or adjust several options via the Program Options button. The Program Options include the following:
Table 6: Program Options
# Feature Description
1Battery
For a non‑rechargeable Stimulator, the Energy Use Index for the current Program is displayed. This value is
used to provide an estimate of battery longevity for the non‑rechargeable Stimulator on the current Program.
See the “Energy Use Index” section of this manual for more information.
For a rechargeable Stimulator, an Estimated Charge Time for the current Program is displayed. This value
provides an estimate of the duration and frequency of charging necessary to maintain stimulation.
2Ramp
Time to gradually increase the stimulation from zero to the programmed Amplitude when stimulation is turned
ON.
Default Options Range
ON ON/OFF 1 sec to 10 sec
3Cycle
The cycled on and off duration of stimulation delivery.
Default Options Range
OFF ON/OFF 1 sec to 90 min
4Copy to Copy the current Program settings to another Program.
5 Delete Delete the settings for the current Program.
Selecting Stimulation Areas
For a given Program, you may congure up to four Areas. With a new Program, an Area will be automatically assigned to each brain hemisphere
and named based on the dened Target and side of the brain selected in the Congure Tab. You may add an additional Area by selecting
an empty Area (+) and choosing a conguration (e.g. Left STN). You may reassign an Area by rst selecting Options for that Area and then
choosing Delete Area. You may then select a different hemisphere conguration.
Note: Predened simulations may be imported from Elements by selecting Load Simulation from the Area Options button.
Selecting Contacts
You can manually assign anodes and cathodes in Custom Mode or incrementally steer a stimulation eld along the Lead in the Steering Mode.
Steering Mode is limited to a monopolar conguration of either a single cathode or adjacent cathodes.
To provide anodic stimulation, you must use Custom Mode. You may assign the Stimulator Case and all the Contacts as anode or cathode
individually in Custom Mode. The External Trial Stimulator (ETS) is limited to Custom Mode since the Stimulator Case cannot be assigned as a
cathode or anode.
Note: Switching from Custom Mode to Steering Mode will clear the Contact and Stimulator Case assignments.
Note: Stimulation using multiple independent current control (MICC) with a Directional Lead is referred to as Cartesia 3D.
Note: Stimulation with only Lead Contacts assigned as anode(s) and the IPG case assigned as cathode is referred to as Monopolar Anodic
Stimulation (MAS).

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Steering Mode
Steering Mode is a simplied programming mode where the Contact(s) act as the cathode(s) and the Stimulator Case acts as the anode.
This mode allows you to steer a monopolar cathode along the Lead, eliminating the need to turn ON and OFF individual Contacts. Steering
Mode incrementally shifts a percentage of the cathodic current to the adjacent Contact(s) using current steering technology to create smooth
transitions between Contacts.
The DB‑2201 Standard Lead has eight ring Contacts per Lead, labeled 1 through 8 on each Lead.
To Steer along the DB‑2201 Standard Lead:
1. Select Steering Mode.
2. Select a Contact to assign it as a 100% cathode.
3. Use the and buttons to incrementally steer the stimulation focus along the length of the Lead. The amount of cathodic current
will shift in 10% increments.
Note: You may also adjust directly from one Contact (Level) or half level to another. The Amplitude for the selected Area will drop to
0 mA when another Contact is selected, but not when steering in 10% increments.
The DB‑2202 Directional Lead has a total of eight Contacts per Lead, labeled 1 through 8 on each Lead. Contacts 1 and 8 are the distal tip and
proximal ring Contacts, respectively, while Contacts 2 through 7 are the small directional Contacts (segments) grouped into two rows of three
segments each.
To Steer along the DB‑2202 Directional Lead:
1. Select Steering Mode.
2. Select a Contact to assign it as a cathode. You may create an equal spread of current across a Level of Contacts (“ring mode”) by
selecting anywhere within that Level, then selecting the center button. To assign a single directional segment as the cathode, select
anywhere within that Level, then select the corresponding button (Figure 15).
Figure 15. Directional Contact Selector
3. Use the and buttons to incrementally steer the stimulation focus along the length of the Lead.
Note: You may also adjust directly from one Contact (Level) or half level to another. The Amplitude for the selected Area will drop to
0 mA when another Contact is selected, but not when steering in 10% increments.
4. Select one of ve preset directions for the stimulation eld. The directional presets will steer the fully focused
stimulation eld in one of four orthogonal directions or put the stimulation eld into “ring mode.”

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The following steps can be used to rene the applied directional preset or selected directional segment.
5. Use the and buttons to rotate and steer the stimulation focus circumferentially around the Lead. Each rotation is
30 degrees.
6. Use the and buttons to radially spread or shrink the focus of the stimulation eld.
7. To choose another starting point or to steer on another Contact, select another Contact. To select a segmented Directional Contact,
select the Level, then select one of the three labeled segmented Contacts around the circumference of the center button on the
Directional Contact Selector.
Note: The total Amplitude for the selected Area will drop to 0 mA when another Contact is selected.
Note: Stimulation using multiple independent current control and the Directional Lead is referred to as Cartesia 3D.
Custom Mode
Custom Mode allows you to assign a percentage of anodic or cathodic current to individual Contacts and the Stimulator Case.
To program in Custom Mode:
1. Select Custom Mode.
2. Select the Stimulator Case or Contact that you want to adjust. If it was selected, one tap will assign it as an anode (+). Another tap will
reassign it as a cathode (‑). Another tap will reassign it as OFF (blank). Tapping on a Contact will rst select it without changing the
polarity.
Note: Changing the Contact polarities will reset the Amplitude to zero.
3. Select the +and – buttons for the Contact to adjust the percentage of anodic or cathodic current assigned to the selected Contact.
Note: When using the External Trial Stimulator (ETS), monopolar congurations are not possible since the ETS “case” cannot be
assigned as a cathode or anode.
Note: When using the ETS, Clinical Effects data is recorded but not plotted on the CEM.
Turning Stimulation OFF for Individual Areas
To turn stimulation OFF for Individual Areas:
1. Make sure the Area you wish to turn OFF is selected by clicking on the appropriate Area on the Area Panel.
2. Press the Stimulation OFF button to turn Stimulation OFF.
Note: When the Amplitude is at 0 mA, increase the Amplitude to turn ON stimulation.
Turning All Stimulation OFF
Selecting the button will stop stimulation for all active Areas. This function is only meant for turning all Stimulation OFF. To turn Stimulation
ON, select each Area that you want to turn ON and select the Stimulation ON/OFF switch.
Increasing and Decreasing the Amplitude
Amplitude is measured in milliamperes (mA). The default setting for Amplitude is 0 mA and the range is 0 to 20 mA. The maximum Amplitude for
a single Contact is 12.7 mA.
To increase or decrease the Amplitude:
1. Use the + and – buttons labeled Total Amplitude to increase or decrease Amplitude.
2. The default step size for Amplitude changes is 0.1 mA. You can change the step size to 0.5 mA using the Step Size buttons.
Note: High stimulation levels can cause permanent tissue damage. A message will pop‑up notifying you if you attempt to exceed a
stimulation limit and settings that exceed this limit are not allowed.

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Increasing and Decreasing the Pulse Width
The Pulse Width of the stimulation is the length of time a burst of energy is applied per pulse. The Pulse Width is measured in microseconds
(μS). The default setting for Pulse Width is 60 μS and the range is 20 to 450 μS.
To increase or decrease the Pulse Width:
1. Select the Pulse Width button.
2. Select the desired Pulse Width from the options provided. Pulse Widths that exceed stimulation limits are greyed out.
Note: High stimulation levels can cause permanent tissue damage.
Note: Increasing the Pulse Width by more than 10 microseconds (μS) at a time will cause the total Amplitude to be reset to 0 mA.
Increasing and Decreasing the Rate
The pulse rate of the stimulation, often called the Rate or the Frequency, dictates how many stimulation pulses are delivered in a second,
measured in Hertz (Hz) or pulses per second (pps). The default setting for Rate is 130 Hz and the range is 2 to 255 Hz.
To increase or decrease the Rate:
1. Select the Rate button.
2. Select the desired Rate from the table of available Rates. Incompatible Rates are greyed out.
Note: Areas that are assigned to the same Lead Port cannot have Rates that sum up to greater than 255 Hz.
Programming Multiple Areas with Different Rates
Areas are allowed to be programmed with different Rates. By default, the Multiple Rate option is disabled. When you enable Multiple Rates, only
the Rates that are compatible with the Rates and Pulse Widths from the other active Areas are available.
Note: Modifying the Rate of an Area will alter the available Rates for the other Areas.
Note: If you disable Multiple Rates, the Rate for all Areas with be reset to the Rate selected for the current Area.
Selecting Patient Amplitude Range
By default, patients do not have the ability to adjust the Amplitude of their stimulation.
However, in some cases, you may want to give a patient the ability to adjust the Amplitude of their stimulation using the Remote Control. To give
patients Amplitude Control, rst turn ON the Patient Amplitude Control in the Congure Tab. Once the Patient Amplitude Control is turned ON,
you can set the allowable Amplitude range in the Program Tab for each Area by setting a Minimum and Maximum.
Note: High stimulation levels can cause permanent tissue damage. A message will pop‑up notifying you if you attempt to exceed a stimulation
limit and settings that exceed this limit are not allowed.