Page 1
Directions for Use
en esfr ptBR
Vercise™ DBS
Programming Manual
Directions for Use
Mode d’emploi
Instrucciones de uso
Instruções de uso
91053785-07
Content: 91072420 REV AB
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Vercise™ DBS Programming Manual
Trademark
All trademarks are the property of their respective holders.
Guarantees
Boston Scientic 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
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For indications, contraindications, warnings, precautions, adverse events summary, sterilization,
component disposal, storage and handling, and warranty information, refer to the Information for
Prescribers DFU for your Vercise DBS System. For other device-specic information not included
in this manual or labeling symbols, refer to the appropriate DFU for your Vercise DBS System as
listed on your DBS Reference Guide.
Product Model Numbers
Model Number Description
DB-7153-203 Vercise Clinician Programmer
DB-7153-203-R Vercise Clinician Programmer (Refurbished)
DB-7153-N1 Vercise DBS Clinician Programmer
DB-7153-N1-R Vercise DBS Clinician Programmer (Refurbished)
DB-1110-C Vercise IPG Kit
DB-5110-C Vercise ETS
DB-5212-C Vercise Remote Control
DB-5500-C Vercise Remote Control Kit
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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 Prole ......................................................................................................... 13
Entering and Editing Patient Information ............................................................................. 13
Entering Patient Notes ......................................................................................................... 14
Viewing a Patient’s Case History ......................................................................................... 15
Conguring the Vercise DBS System .......................................................................................... 16
Verifying the Vercise DBS System Conguration ................................................................ 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
Dening 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
Managing System Settings ........................................................................................................... 67
Viewing the System Settings ............................................................................................... 67
Adjusting the Default Pulse Width ....................................................................................... 68
Adjusting the Default Rate ................................................................................................... 69
Adjusting the Default Ramp Time ........................................................................................ 70
Selecting the Default Remote Control Language ................................................................ 71
Setting the Patient Name Display Preference ..................................................................... 72
Addendum ...................................................................................................................................... 73
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 conguring stimulation parameters.
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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 specic 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
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Welcome to Bionic Navigator™ by Boston Scientic.
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 benets
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 and Frequently
Asked Questions (FAQs) sections.
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 dened 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 any 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 Click on the Vercise Launcher icon on the desktop.
7 Select the Vercise DBS System icon to start Bionic Navigator.
Note: The Vercise Navigator may also be accessed on the same CP using Vercise
Launcher. Refer to the Vercise DBS Reference Guide for instructions on
which software application to use with your Deep Brain Stimulation System.
Refer to Vercise Navigator Manual with Vercise Navigator for instructions on
Vercise Navigator.
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Note: Bionic Navigator and Vercise Navigator should not be run simultaneously on the
same CP.
8 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).
9 Enter the Clinician’s screen on the Remote Control by pressing and holding both the and
P buttons simultaneously.
10 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 dened as the process of conguring the Remote Control to communicate with a specic
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:
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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 Conrm the link by pressing the P button or cancel by pressing the button.
If programs are
stored in the…
Remote Control
Stimulator
Remote Control
Stimulator
Then…
The Remote Control will automatically download the programs from
the Stimulator.
The Remote Control will automatically download the programs from
the Stimulator.
Remote Control
Stimulator
Remote Control
Stimulator
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The Remote Control will ask if you want to download the Remote
Control programs to the Stimulator.
Enter the password A-B-C to download the Remote Control
programs to the Stimulator.
The Remote Control will be linked to the Stimulator immediately.
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Setting Up
If programs are
stored in the…
Remote Control
External Trial
Stimulator
Remote Control
External Trial
Stimulator
Remote Control
External Trial
Stimulator
Then…
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.
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The Remote Control will prompt you to clear the programs on the
External Trial Stimulator.
The Remote Control will ask if you want to download the Remote
Control programs to the External Trial Stimulator.
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 Conrm that you want to clear the link by pressing the P button or cancel by pressing the
button.
5 Enter the password A-B-C.
Note: To re-link the Remote Control, see 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.
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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 dened 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 dened in the table below and further described
in several sections of this guide.
Click… to…
Access the Prole screen.
Access the Conguration screen.
Turn stimulation on (applies to all areas with Amplitude set at a
value greater than zero).
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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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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 Prole Screen will automatically be displayed.
3 Fill in the patient’s information.
For more information on the Prole Screen, see Managing a Patient’s Prole 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.
Starting a Session
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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 Prole
Entering and Editing Patient Information
To create or edit a patient’s prole:
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 Prole Screen.
Note: If no patient was selected, it is assumed that you wish to create a new patient and
the elds on the Prole 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.
Managing a Patient’s Prole
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● 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 Prole Screen, click in the upper right corner of
any screen.
2 Click towards the bottom of the Prole 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
Prole Screen.
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Managing a Patient’s Prole
Viewing a Patient’s Case History
Case History displays chronologically dated patient le information, including the visit history and
notes. Each visit is time stamped and displayed along with the Reason for Visit and Notes.
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Note: Patient visits are recorded and time stamped only when the user exits or saves the
Prole Screen.
To view a patient’s Case History:
1 If you are not currently in the Prole Screen, click in the upper right corner of
any screen.
2 Click towards the bottom of the Prole Screen.
3 To exit, click .
Case History is read-only. To enter new Notes, see Entering Patient Notes on page 14.
To print a patient’s Case History, see Creating Reports on page 51.
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Conguring the Vercise DBS System
Verifying the Vercise DBS System Conguration
The Conguration (or Cong) screen displays information about the system components. The
Stimulator and Remote Control product and serial numbers are automatically detected and
recorded. The Lead information is also displayed.
Note: The Conguration screen may only be accessed once a patient is selected.
To verify the Vercise DBS System conguration:
1 Click in the upper right-hand corner of any screen.
If Lead information has not been entered, the information will be requested before the
Conguration screen is displayed.
2 Verify that the Lead information is correct.
3 Verify that the Stimulator model and serial number are correct.
4 Verify that the Remote Control model and serial number are correct.
5 Verify that the electrode labels correctly correspond to the left and right Leads (in the image
of the Leads to the right of the screen).
By default, Bionic Navigator assigns contacts 1-8 to the left Lead and contacts 9-16 to the
right Lead. If the contacts to not correspond correctly, see Swapping the Leads on page 18.
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Conguring the Vercise DBS System
Modifying the Lead Information
To modify the Lead information:
1 Click from the Start Screen.
2 Click to modify the lead information.
3 Choose the appropriate Lead model from the Lead 1 drop-down menu.
4 Choose the appropriate Lead model from the Lead 2 drop-down menu. If using only 1
Lead, select None from the Lead 2 drop-down menu.
5 Click to save your changes or to exit without your changes.
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Swapping the Leads
By default, Bionic Navigator assigns contacts 1-8 (1-L port) to the Lead that appears on the left and
contacts 9-16 (2-R port) to the Lead that appears on the right.
To aid in programming the Stimulator, you may wish to rearrange the display so that the Lead
connected to port 1-L (contacts 1-8) appears on the right, and the Lead connected to port 2-R
(contacts 9-16) appears on the left.
Note: This function only visually changes the order of the Leads on the Conguration
and Programming screens. It does not change the order of the Leads displayed in
reports or programs, which list contacts 1-8 followed by contacts 9-16.
To rearrange the display of the Lead(s) (left to right):
1 Click from the Conguration screen.
2 Click to change the connection of the Leads to the Stimulator ports.
3 Click to save your changes or to exit without saving your changes.
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Conguring the Vercise DBS System
Testing Impedances
The Impedance button is used to verify electrical integrity. Lead impedance is measured and
displayed for each of the Stimulator’s 16 contacts. Impedances over 4500 Ω are considered to be
resultant from open or unconnected wires and are displayed with an orange bar on the Impedance
screen (or an “X” on the Program screen).
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To check the Lead impedances:
1 Click while in the Conguration screen or the Program screen.
The impedances will be measured and displayed. To re-measure the impedances, click
.
Note: All measured impedances are saved into the Clinician Programmer database.
2 To print the impedance report, click .
3 To exit, click .
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Programming the Patient
Stimulator Programmable Characteristics
The stimulation parameters are independent for the two DBS Leads such that stimulation of two
different brain targets can have different amplitudes, pulse widths, stimulation rates, and contact
congurations.
It is possible to congure one lead as monopolar, and one as multipolar. It is also possible to
congure a single lead with both monopolar and multipolar areas, as long as the same contacts are
not used in both.
The programmable parameter ranges for the Stimulator are shown below.
Stimulator Function
Parameter Range
2, 3
1
0.1 – 20 mA
2 – 255 Hz
4
10 – 450 µs
Amplitude
Rate
Pulse Width
Cycle (On/Off) 1 s – 90 min
Stim Ramp On 1 – 10 s
Contact Connections 16
Independent Areas of Stim
(4 Programs with 4 Areas per Program)
1
The programmable coverage for each individual contact is limited to 12.7 mA. A programming interlock is enforced to
limit the total output current to 20 mA or less per coverage area. For example, a maximum current output of 12.7 mA on
one contact would limit the total summed current output on the remaining contacts to 7.3 mA within one coverage area.
2
The rate is limited to 255 Hz for a given area.
3
The use of higher frequencies than the ones that are established (250 Hz) is the sole responsibility of the user.
4
The use of lower pulse widths than established (60-450 μsec) is the sole responsibility of the user.
16
Note: While it is possible to program stimulation rates higher than 255 pps, clinical
effectiveness and safety of these cumulative rates has not been demonstrated and
is not recommended.
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Programming the Patient
WARNING: Although the CP utilizes warnings to aid clinicians in their determination of safe
charge density levels, the primary responsibility of keeping safe current levels
resides with the clinician. Additionally, maximum and minimum amplitude
levels allowed by the Remote Control should be set and veried by the
physician to ensure that these levels are safe.
Getting to the Programming Screen
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The Programming screen displays the active stimulation settings and allows programming of
stimulation parameters.
To get to the Programming screen, select at the bottom center of any screen.
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Selecting an Area
Stimulation settings can be programmed for up to four different stimulation elds or Areas. For
example, one Area may correspond to a right brain target, while another Area may correspond
to a left brain target. These Areas run in an interleaved fashion, and multiple Areas (up to four)
constitute a program. Stimulation parameters and the contact conguration are displayed for one
selected Area at a time.
To select an Area:
1 Click the on the desired Area control box on the left of the Programming screen, as
highlighted in the image below.
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Programming the Patient
Selecting Contacts
You may program the patient either by manually selecting anodes and cathodes in Custom Mode
or automatically trolling the stimulation eld along the lead in E-Troll Mode. Both monopolar and
multipolar congurations are permitted in Custom Mode.
A monopolar conguration uses only cathode(s) on the contacts, with the stimulator case acting as
the anode. A multipolar conguration has anode(s) and cathode(s) assigned to the contacts.
Note: Prior to measuring impedances for the rst time, all contacts will display an “X” After
an impedance measurement, only contacts with an Impedance over 4500 Ω will
display an “X”. Impedances over 4500 Ω are considered to be resultant from open
or unconnected wires. Although an “X” inside a contact indicates higher than normal
impedances, contacts may still be included in a stimulation conguration.
E-Troll Mode
E-Troll Mode is an enhanced way of conducting a monopolar review. E-Trolling allows you to
steer a monopolar cathode along the selected Lead with a single button – eliminating the need to
manually select each contact. E-Troll gradually shifts a percentage of the monopolar cathode to the
next contact using current steering technology to create smooth transitions between contacts.
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To E-Troll along a lead:
1 Switch to E-Troll mode by clicking in the middle of the screen.
2 Select a contact to assign it as a cathode and adjust the amplitude.
3 Use the and buttons in the E-Troll panel to incrementally steer the
stimulation focus.
To choose another starting point or to E-Troll on the other lead, click another contact.
Note: The amplitude for the selected Area will drop to 0.1 mA when another contact
is selected.
Note: Contacts assigned in a multipolar conguration in one Area cannot be assigned to a
monopolar conguration in another Area, so E-Trolling is interrupted in such cases.
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Custom Mode
Custom Mode allows you to manually select contacts to be anodes or cathodes. You may create
both monopolar and multipolar congurations of contacts in Custom Mode.
1 If necessary (i.e., to switch to Custom Mode from E-Troll Mode), press the
button at the top of the middle panel on the Programming screen.
2 Click on a contact to select that contact.
3 Click on the selected contact to turn the contact into an anode.
Click on the selected contact again to turn the contact into a cathode.
Click on the selected contact again to turn the contact OFF (blank).
Contact polarity options include anode (+), cathode (-), and OFF (blank).
Note: Changing the contact polarities will reset the amplitude to zero.
4 Repeat steps 3-4 until all desired contacts are selected.
Click… to…
Increase the percentage of total cathodic or anodic
current on the selected contact.
Decrease the percentage of total cathodic or anodic
current on the selected contact.
Equalize the percentages of current on all contacts of
the selected contact type (anode or cathode).
Measure the impedances of the contacts.
Note: When using the External Trial Stimulator, if a monopolar conguration is
programmed, then all unassigned contacts will contribute as anodes.
Note: Contacts assigned to a monopolar conguration in one Area cannot be assigned
to a multipolar conguration in another Area and vice versa.
Note: Although an “X” inside a contact indicates higher than normal impedances, contacts
may still be included in a stimulation conguration.
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Programming the Patient
Turning Stimulation On and Off for Individual Areas
To turn ON stimulation for an Area:
1 Make sure the Area you wish to turn on is selected.
To select an Area, see Selecting an Area on page 22.
Note: To initially turn on stimulation for an area, that area must rst be congured with at
least one cathode.
2 Click the button of the selected area to turn stimulation ON.
To turn OFF stimulation for an Area:
1 Make sure the Area you wish to turn off is selected.
To select an Area, see Selecting an Area on page 22.
2 Click the button of the selected Area to turn stimulation OFF.
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Increasing and Decreasing the Amplitude
The amplitude of stimulation is the peak value of a stimulation pulse and is measured in
milliamps (mA).
To increase or decrease the amplitude of the selected area:
1 To increase the amplitude, click or click and hold one of the up arrows above the AMP label
on the Programming screen.
2 To decrease the amplitude, click or click and hold one of the down arrows above the
AMP label..
Click… to…
Increase the amplitude quickly.
Increase the amplitude slowly.
Decrease the amplitude slowly.
Decrease the amplitude quickly.
To increase or decrease the amplitude for all areas that have stimulation turned on:
1 On the Programming screen, click the button.
If the Global button is selected (the button will have a bright blue circle around it), only the
amplitude can be adjusted.
2 Increase or decrease the amplitude as described above.
3 Click the button again to discontinue Global amplitude adjustment.
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Programming the Patient
Increasing and Decreasing the Pulse Width
The pulse width of the stimulation describes the length of time a burst of energy is applied to the
desired area. The pulse width is measured in microseconds (µS).
1 To increase the pulse width, click or click and hold the button below the PW label on
the Programming Screen.
Note: If you attempt to adjust the pulse width above the charge density limit, then you will
see a caution message.
2 To decrease the pulse width, click or click and hold the button below the PW label.
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Increasing and Decreasing the Rate
The pulse rate of the stimulation, often called just the rate or the frequency, dictates how many
stimulation pulses are delivered in a second, measured in Hertz (Hz) or pulses per second (pps).
1 To increase the rate, click or click and hold the button below the RATE label on the
Programming Screen.
Note: If you attempt to adjust the rate above the charge density limit, then you will see a
caution message.
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2 To decrease the rate, click or click and hold the button below the RATE label.
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Programming the Patient
Programming Multiple Areas
Programming Multiple Areas with the Same Rate
The Vercise™ DBS System allows two Areas to be programmed with the same rate (or frequency).
If more than two Areas are turned on, then all Areas must have the same rate.
Note: The rates for the rst and second Areas must be equal to one another before a third
Area may be turned on.
Programming Two Areas with Different Rates
The Vercise DBS System allows two Areas to be programmed with different rates (or frequencies).
This feature allows you to simultaneously stimulate two areas of the brain with different rates.
To program two Areas with different rates:
1 Turn on one Area and turn off all the other Areas.
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2 Select the desired rate for the rst Area.
3 Turn on a second Area.
4 Select the desired rate for the second Area.
Note: You will have a limited number of rates available for programming when selecting
the rate for the second Area.
Note: Modifying the rate of either Area will alter the available rates for the other Area.
Note: When establishing two areas with different rates, the rst area must be on while the
rate for second area is programmed.
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The two rates are dependent on one another in that only certain combinations of rates are
permitted. The table below indicates which frequencies are available for the second Area at
commonly used frequencies for the rst Area.
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First Area
Rate (Hz)
99
132
179
238
*Subset includes only frequencies in typical DBS range (89-255 Hz) using typical pulse widths
(30-90 μs).
†Available when both pulse widths are less than or equal to 60 μs.
‡
Available when both pulse widths are less than or equal to 30 μs.
Subset of Available Second Area Rates (Hz)*
89†, 99, 112†, 113†, 116†, 119, 128†, 132, 139†, 149, 154‡, 159†, 170‡,
174†, 179†, 198, 223†, 231†, 238
‡
99, 113†, 116‡, 119‡, 132, 149‡, 154‡, 159†, 170‡, 176, 185‡, 198,
231‡, 238
‡
89, 99†, 104‡, 112†, 119, 128†, 139‡, 143†, 149†, 179, 208‡, 223†,
†
238
89†, 95, 99‡, 119, 132‡, 136‡, 143†, 149‡, 159, 170‡, 179†, 190‡,
198‡, 238
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Programming the Patient
Dening the Amplitude Range
By default, patients will 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. In these cases, you must unlock Remote Control amplitude adjustments
and dene an amplitude range.
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The Area Settings screen allows you to view and edit the amplitude range allowed by the patient’s
Remote Control. The amplitude range is dened by the minimum and maximum stimulation
amplitude. The patient may only adjust his or her stimulation amplitude within this range.
Note: The patient cannot adjust the pulse width and rate of stimulation with the Remote
Control.
To unlock the ability for patients to adjust stimulation amplitude with the Remote Control:
1 Click from any screen.
2 Click on the left of the screen.
3 Uncheck the Lockout Remote Amplitude option.
To dene the amplitude range for an Area:
1 Ensure “Lockout Remote Amplitude” is disabled (see above).
2 From the Program screen, click in the desired Area tab.
Each Area may have a different amplitude range.
3 Set the minimum amplitude using the buttons in the top box.
The minimum amplitude allowed is 0 mA.
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4 Set the maximum amplitude using the buttons in the bottom box.
The maximum amplitude allowed is 20 mA.
5 Click to save your changes or to exit without saving.
Note: A charge density limit warning will be displayed on the Programming screen when
the maximum amplitude setting for any area is above the charge density limit and
will clear when the maximum amplitude settings for all areas are below it.
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Programming the Patient
Understanding the Charge Density Warnings
The Clinician Programmer software provides several warnings when the charge density at a
contact may exceed 30 microcoulombs/cm2 per stimulation phase, as there is evidence of tissue
damage above this level. The graph below displays the recommended maximum charge density of
30 microCoulombs/cm2 for different combinations of current amplitude (mA) and pulse width (µs)
for Boston Scientic DBS Leads.
2
30 uC/cm
Current Amplitude (mA)
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Pulsewidths (usec)
The Clinician Programmer software provides a warning when the charge density at a contact is
about to be programmed to exceed 30 microcoulombs/cm2 per stimulation phase. However, the
Clinician Programmer allows the stimulation to continue above this level. The warning reads:
“CAUTION: Charge density limit reached. Continue programming at your discretion.”
Note: A charge density limit warning will be displayed on the Programming screen while
any area is above the charge density limit and will clear when all areas are below it.
A warning is also displayed when the amplitude range of a program exceeds charge density limits.
The warning reads:
“Caution: With present settings, the patient could exceed the charge density limit with
the remote control. Continue programming at your discretion.”
Another warning is displayed when a program that is capable of exceeding the charge density limit
is saved to a program slot in the patient’s Remote Control. The warning reads:
“Caution: Charge density limit may be reached with the current Max mA set. Do you
want to continue?”
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Naming the Areas
You are able to name each Area so that you, and the patient, are reminded of the anatomical
location of each stimulation Area. For example, you may name one Area “Left” for a stimulation
Area located on the left side of the brain and another Area “Right” for a stimulation Area located on
the right side of the brain.
Note: The Area names are displayed on the Clinician Programmer.
To name an Area:
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1 Make sure the Area you wish to name is selected.
To select an Area, see Selecting an Area on page 22.
2 Click on the Area’s name.
The default Area names are Area 1, Area 2, Area 3, and Area 4.
3 Edit the text.
Area names may not exceed eight characters in length.
4 Click to save the changes or to exit without saving your changes.
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Programming the Patient
Naming the Program
You can name each program so that you and the patient are reminded of the purpose of each
program. For example, you may name one program “Sleeping” and another program “Walking.”
Note: The program names are displayed on the Clinician Programmer and the patient’s
Remote Control.
To name a program:
1 From the Programming screen, click next to the Program eld near the top of the
screen.
2 Edit the text.
Program names may not exceed nine characters in length.
3 Click to save the changes or to exit without saving your changes.
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Globally Turning Stimulation Off and On
The Stimulation Power button will stop and start stimulation for those Areas that are active (turned
on). The Stimulation Power button will only apply to active Areas.
To turn stimulation OFF for all active Areas:
1 Click the red button in the lower left-hand corner of any screen. Stimulation will
stop for those Areas that are turned on.
To turn stimulation ON for all previously active Areas:
1 Click the green button in the lower left-hand corner of any screen. Stimulation will
ramp up to the stored amplitude levels for the active program settings.
Stimulation will turn on for those Areas that were last turned off by clicking the “STOP”
button.
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Adjusting Patient Options
Programming the Patient
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The Patient Options window allows you to view and edit additional program settings, including
stimulation cycling, ramp up time, and Remote Control amplitude lockout. Program settings are
only applied to the currently active program (which appears on the left side of the Remote screen).
After making changes to Patient Options, save the currently active program to a slot to preserve
the changes.
To access Patient Options:
1 Click from any screen or from the Programming screen.
2 Click on the left side of the Remote screen.
Changing the Stimulation Cycle
The Cycle option determines the on and off duration of stimulation delivery.
For continuous stimulation, the Cycle option should be unchecked.
The option is unchecked by default, resulting in continuous stimulation.
For intermittent stimulation:
1 Check the box next to the Cycle option.
2 Set the stimulation on time using the buttons next to the On eld.
The range for stimulation on time is 1 second to 90 minutes.
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3 Set the stimulation off time using the buttons next to the Off eld.
The range for stimulation off time is 1 second to 90 minutes.
4 If desired, check Set as Patient Defaults to save these settings to the Remote Control as
defaults.
Note: If the Set as Patient Defaults is checked, these program settings will be used for all
future programs created for the current patient.
5 Click to save your changes or to exit without saving.
Dening the Stimulation Ramp Up Time
The stimulation Ramp Up time is the amount of time the Stimulator will take to increase stimulation
from 0 mA to the programmed amplitude when stimulation is turned on.
To dene the Ramp Up time:
1 Check the box next to the Ramp Up option.
2 Set the Ramp Up time using the buttons next to the Ramp Up eld.
The default setting is 3 seconds. The range for Ramp Up time is 1 to 10 seconds.
3 If desired, check Set as Patient Defaults to save settings to the Remote Control as defaults.
Note: If the Set as Patient Defaults is checked, these program settings will be used for all
future programs created for the current patient.
4 Click to save your changes or to exit without saving.
Activating or Deactivating Patient Amplitude Control
The Lockout Remote Amplitude option controls the patient’s ability to change stimulation amplitude
using the Remote Control.
Note: The patient will be able to adjust their own amplitude level using the Remote Control
if the Lockout Remote Amplitude option is unchecked.
To activate or deactivate the Lockout Remote Amplitude option:
1 Check or uncheck the box next to the Lockout Remote Amplitude option.
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Programming the Patient
The Lockout Remote Amplitude option is activated. The
patient cannot change the stimulation amplitude using the
Remote Control.
The Lockout Remote Amplitude option is deactivated. The
patient is able to change the stimulation amplitude using
the Remote Control.
2 If desired, check Set as Patient Defaults to save settings to the Remote Control as defaults.
Note: If the Set as Patient Defaults is checked, these program settings will be used for all
future programs created for the current patient.
3 Click to save your changes or to exit without saving.
Setting Program Options as Patient Defaults
The Set as Patient Defaults option allows you to use the current program settings (Cycle, Ramp
Up, and Lockout Remote Amplitude) for all new programs created for the current patient.
1 Check or uncheck the box next to the Set as Program Defaults option.
The current program options will be used for all future
programs created for the current patient.
The default program options will be used for all future
programs created for the current patient.
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2 Click to save your changes or to exit without saving.
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Managing Programs
Getting to the Remote Screen
The Remote Control screen displays programs stored on the patient’s Remote Control, as well as
the currently active program.
To get to the Remote Control screen:
1 Click from the Programming screen or in the lower right-hand corner
of any screen.
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Managing Programs
Understanding the Program Slots
The program currently running on the stimulator is displayed on the left panel. On the right side of
the screen, the four program slots are displayed.
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Currently Active
Program Slot
Remote Control
Program Slots
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Saving a Program
The currently active program can be saved to one of the four program slots. Programs are stored in
the Stimulator and accessed/controlled by the Remote Control. The Remote Control also stores a
copy of the programs.
To save a program to the Stimulator:
1 Name the program by clicking “Edit” at the top of the left panel, typing a program name,
and selecting the “check mark”. The program name will be displayed on the Remote
Control.
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2 Click a program slot on the right of the screen to which you want to save the program.
You can select a blank slot to save a program to, or you can select a slot that already has a
program to overwrite it.
3 Click .
The currently active program will be saved to the selected program slot.
Note: The symbol in the Remote Control panel indicates last activated or saved
program.
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Managing Programs
Activating a Program from the Remote Control Panel
A program that has been stored to one of the four program slots may be activated to become the
current stimulation program. The activated program may then be modied in the Programming
screen. Depending on the steps you take below, you may activate a program with stimulation on or
stimulation off.
To activate a program:
1 Click the program on the right of the screen that you want to activate.
Note: The symbol indicates last activated or saved program.
2 To activate the program with stimulation on, click .
If stimulation is off, stimulation will turn on. If stimulation is already on, stimulation will
remain on.
3 To activate the program with stimulation off, click .
If stimulation is on, stimulation will turn off. If stimulation is already off, stimulation will
remain off.
Note: If the current program has not been saved, then a pop-up window will ask if you
want to continue. If you do not want to save the current program, click
to continue and activate the selected program. If you do want to save the current
program, click and save the current program.
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Previewing a Program from the Remote Control Panel
The Preview feature allows you to compare and contrast programs. Before overwriting the currently
active program, a program in the Remote Control may be previewed.
Note: The preview feature may be used to determine which program on the Remote
Control you wish to overwrite if all program slots are lled.
To preview a program:
1 Click the desired program on the right side of the Remote screen.
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2 Click to preview the program.
The currently active program will be stopped and the selected program will be temporarily
activated.
3 Click or to keep the program active, or to return to the
previously active program.
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Managing Programs
Deleting a Program
When a program is deleted, it is removed from the stimulator and will no longer be displayed on the
remote control. To delete a program:
1 Click the desired program on the right side of the Remote screen.
2 Click to erase the program from the Stimulator and Remote Control.
Upon deleting the program, the program slot will become empty.
3 A pop-up will ask you if you want to delete the program. Click to conrm the
deletion or to exit without deleting.
Note: If you accidentally delete a program from the Remote Control, you can nd the
program in the Program Database.
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Checking the Stimulator Battery Status and Viewing the
Estimated Charging Time
The Battery Status screen displays the battery level of the Stimulator and gives an estimate of the
time required to charge which will help you to determine a charging routine. Battery level options
include full, medium, and low. The voltage of the Stimulator battery is also displayed.
To check the status of the Stimulator battery:
1 From the Remote screen, click .
To re-measure the battery status, click .
2 If necessary, click to print the battery status.
3 Click to exit.
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Managing Programs in the Program Database
Managing Programs in the Program
Database
Viewing Programs in the Program Database
The Program Database screen displays a list of all stimulation programs that have previously been
saved using the current CP (Clinician Programmer).
To view the programs in the Program Database:
1 From the Remote screen, click .
2 Use the and buttons to navigate within the Program Database.
The currently active program slot is displayed in the left panel and database programs are
displayed in the right panel. Four programs in the Program Database are displayed at a time.
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Currently Active
Program Slot
Program Database
Program Slots
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Activating a Program from the Program Database
A program located in the Program Database may be activated to become the current stimulation
program. The activated program may then be modied in the Program screen. Depending on the
steps you take below, you may activate a program with stimulation on or stimulation off.
To activate a program:
1 Click the program on the right of the screen that you want to activate.
2 To activate the program with stimulation on, click .
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If stimulation was off, stimulation will turn on. If stimulation was already on, stimulation will
remain on.
To activate the program with stimulation off, click .
If stimulation was on, stimulation will turn off. If stimulation was already off, stimulation will
remain off.
Note: If the current program has not been saved, then a pop-up window will ask if you
want to continue. If you do not want to save the current program, click
to continue and activate the selected program. If you do want to save the current
program, click and save the current program.
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Managing Programs in the Program Database
Previewing a Program from the Program Database
Before overwriting the currently active program, a program in the Program Database may be
previewed.
To preview a program:
1 Click the desired program on the right side of the Program Database screen.
2 Click to preview the program.
The currently active program will be stopped and the selected program will be temporarily
activated.
3 Click or to permanently activate the program, or to return
to the previously active program.
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Deleting a Program from the Program Database
To delete a program from the Program Database:
1 Click the desired program on the right side of the Program Database screen.
2 Click to erase the program from the Program Database.
Note: If you delete a program from the Program Database, you cannot recover the
program at a future date.
3 A pop-up will ask you if you want to delete the program. Click to conrm the
deletion or to exit without deleting.
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Creating Reports
Creating Reports
Choosing a Report
The Reports screen is used to create a patient or clinic report based on data from stimulators
used with the CP. The CP does not need to be connected to any IPG to create or view reports. By
selecting various options for individual patients or groups, the user can create, view, print, or export
database information. Reports can be customized through sorting lters.
The ve report types and the information they may include are described in the following sections.
Choose the report that includes the information you require.
Patient information, clinical information, hardware information,
stimulation settings, prole information, battery use information,
case history, and patient notes.
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Programs, threshold measurements, impedances, battery charge
prole, stimulation use prole, and patient history.
Last visit, serial number, implant date, and physician.
Implant, last visit, physician, diagnosis, percentages and means,
implant duration, mean age, replacements, explants, and revisions.
Last visit, physician and patient follow-ups. May include
reprogramming, trials, Lead implants, total patients, average
durations, and total durations.
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Patient Information Report
To create a Patient Information report:
1 Click on the toolbar of any screen.
2 Click the button.
3 Select what information to include in the report by checking the box in front of the option.
Choose from any or all of the following categories:
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● Patient Information: name, address, and date of birth
● Clinical Information: physician name, rst and last programming sessions, and reason
for last visit
● Hardware Information: model and serial numbers of the stimulator and remote control,
and model numbers of the lead(s)
● Stimulation Settings: program options, program details for each saved program
● Use Prole Information: 4 week history of what program numbers were used, in hours
per day
● Battery Use Information: 4 week history of battery charge, in Volts. Also referred to as
a 4 week “battery charge prole”
● Case History: date, reason, and notes for each programming visit
● Patient Notes: notes from the last programming session saved in the prole page for
each patient
4 Select one or more patients from the list on the right side of the screen.
To lter the patients that are shown in the list by the date of their last visit, click the button
next to Today, 2 Days, Week, or All to view patients whose last visit occurred within that
time frame.
5 Click to create the report.
6 To export the report as an electronic le, click .
7 To print the report, click .
8 Click to exit from the report.
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Creating Reports
Generic Report
Generic Report provides different reporting options for one patient based on data acquired within a
specied range of dates. To create a Generic Report:
1 Click on the toolbar of any screen.
2 Click the button.
3 Select the type of report to generate by clicking on the corresponding button. Choose from:
● Programs: all programs created with the CP, including date/time it was saved, slot
number, graphical display of electrode conguration, stimulation parameters, and
options for each program
● Threshold Measurements: not applicable
● Impedances: history of all impedance measurements made with the CP
● Battery Charge Prole: history of battery charge, in Volts, measured at 4 hour
intervals
● Stimulation Use Prole: history of program usage
● Patient History: date, reason, and notes for each visit
4 Select a patient from the Patient drop-down list on the right side of the screen.
5 Limit the results in the report by selecting two dates from the drop-down menus, such that
only information on the selected patient collected during visits that occurred between these
two dates will be included in the report.
6 Select the order the information will be displayed.
Check the box next under the Order option to display the information in an ascending order
(by date). Uncheck the box to display the information in descending order (by date).
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7 Click to create the report.
8 To export the report as an electronic le, click .
9 To print the report, click .
10 Click to exit from the report.
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Patient List Report
Patient List Report lists all patients in the CP’s database, or only those who match the specied
parameters. Report includes patient name, patient ID, IPG serial number, and date of rst
programming session. To create a Patient List report:
1 Click on the toolbar of any screen.
2 Click the button.
3 Select the range of the report by checking the boxes next to one or more options. Options
include:
● Implant Date
Only information on patients who where implanted between the two selected
dates will be included in the report.
Note: “Implant Date” is the date that a stimulator was rst used with this CP.
● Last Visit
Only information on patients whose last visit occurred between the two selected
dates will be included in the report.
● Serial Number
Only information on patients with Stimulator serial numbers between the two
selected numbers will be included in the report
● Physician
Only information on patients with the selected physician will be included in
the report.
4 Click to create the report.
5 To export the report as an electronic le, click .
6 To print the report, click .
7 Click to exit from the report.
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Creating Reports
Clinical Outcomes Report
Clinical Outcomes Report summarizes patient statistics, for one or all physicians. Reported
statistics include number of patients, mean implant duration, mean patient age, and gender
(percentage male/female). To create a Clinical Outcomes report:
1 Click on the toolbar of any screen.
2 Click the button.
3 Select the range of the report by checking the boxes next to the options. Options include:
● Implant Date
Only information on patients who where implanted between the two selected two
dates will be included in the report.
● Last Visit
Only information on patients whose last visit occurred between the two selected
two dates will be included in the report.
● Physician
Only information on patients with the selected physician will be included in
the report.
● Diagnosis
Only information on patients with the selected diagnoses will be included in the
report.
4 Click to create the report.
5 To export the report as an electronic le, click .
6 To print the report, click .
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7 Click to exit from the report.
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Clinical Activity Report
The Clinical Activity Report lists and groups patient visits based on “reason for visit” for one or all
physicians. To create a Clinical Activity report:
1 Click on the toolbar of any screen.
2 Click the button.
3 Select the range of the report by checking the boxes next to one or both options. Options
include:
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● Last Visit
Only information on patients whose last visit occurred between the two selected
dates will be included in the report.
● Physician
Only information on patients with the selected physician will be included in the
report.
4 Click to create the report.
5 To export the report as an electronic le, click .
6 To print the report, click .
7 Click to exit from the report.
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Synchronizing Data
Synchronizing Data
Understanding the Synchronizing Data function
The Synchronize Data function provides a convenient way to manage patient les between clinic
users and multiple Clinician Programmers. Using the Sync Data function, patient data can be
transferred between the database on the Clinician Programmer and an external memory storage
device (referred to as “Patient Card”).
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The “Backup Card” located in the compact ash card slot should never be removed except by
a Boston Scientic Representative. For more information regarding this card, contact Technical
Services. Refer to the Troubleshooting section for contact numbers.
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Installing a New Patient Card
To install a new Patient Card:
1 Insert the Patient Card into any unused USB port. The Patient Card may be any external
storage device (for example, a USB ash drive).
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Synchronizing Data
Synchronizing Data
To synchronize data between the database on the Clinician Programmer and the Patient Card:
1 Insert the Patient Card into any unused USB port. The Patient Card may be any external
storage device (for example, a USB ash drive).
2 Click on the toolbar of any screen.
3 Check the box in front of a specic patient’s name or click to select all the
patients.
Note: If a discrepancy is found between a patient’s information on the Clinician
Programmer and the Patient Card, a window will pop-up displaying both sets of
information. Click under the correct set of information or click
to cancel data synchronization for this patient.
4 Click . When synchronization is complete, the synchronized patients’
names will appear in the right side of the screen, and no names will be selected.
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5 Click .
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Deleting Patient Records
To delete patient records in the database on the Clinician Programmer or on the Patient Card:
1 Click on the toolbar of any screen.
2 Check the box in front of a specic patient’s name or click to select all the
patients. To delete patient records from the CP, select names on the left side of the screen.
To delete patient records from the Patient Card select names from the right side of the
screen.
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3 Click .
4 Click .
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Using Additional Tools
Viewing System Information
Using Additional Tools
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System Information provides the following information about the Vercise™ DBS System:
● Stimulator Telemetry ID
● Stimulator Serial Number
● Stimulator Type
● Stimulator Battery Voltage
● Stimulator Battery Status
● Stimulator Firmware Version
● Remote Telemetry ID
● Remote Firmware Version
Note: System Information can only be accessed when a Stimulator is connected to the
Clinician Programmer.
To view System Information:
1 Click from the toolbar on any screen.
2 Select System Information from the drop-down menu.
3 Click to exit.
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Backing Up Data and Logs
The Backup Data/Logs menu may be used to create a compressed backup le of the system
database and logs.
To backup data and logs:
1 Insert the removable media to copy database and logs.
Note: The removable media should not be named “CLINIC”.
2 Click from the toolbar on any screen.
3 Select Backup Data/Logs from the drop-down menu.
4 Select a drive from the drop-down menu to which the le is to be saved.
5 Click to save or click to exit without saving.
6 Read the agreement and click to accept.
7 A message will appear to conrm that a back up zip le was created successfully. A zip le
will be saved to a folder named BN_Backup on the selected drive. Click to exit.
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Using Additional Tools
Measuring Field Potentials
The EGL Scan™ function in DBS mode measures eld potentials using an impedance-like
measurement. These measurements may be taken for data analysis purposes and stored in
the system, but they will not appear on the screen. If you wish to view this data, contact Boston
Scientic.
To measure eld potentials with EGL Scan:
1 Click from the toolbar on any screen.
2 Select EGL Scan from the drop-down menu. A message will appear to indicate when
measurements are complete.
3 Click to exit.
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Adding a Lead
This custom feature is not supported.
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Using Additional Tools
Enabling and Disabling Auto Impedance
The Auto Impedance feature automatically measures the impedances of the Vercise™ DBS
System when you enter the Programming screen. The Auto Impedance feature will be disabled
whenever the Bionic Navigator software is exited.
If the Auto Impedance feature is disabled, the contacts on the Programming screen will display an
[X] until you measure impedances. If the Auto Impedance feature is enabled, no [X]’s will appear on
the Programming screen (unless impedances are over 4500 Ω for a specic contact).
To enable the Auto Impedance feature:
1 Click from the toolbar on any screen.
2 Select Enable Auto Impedance from the drop-down menu.
To disable the Auto Impedance feature:
1 Click from the toolbar on any screen.
2 Select Disable Auto Impedance from the drop-down menu.
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Viewing Information about Bionic Navigator
To view information about the Bionic Navigator™ software, including the software version, part
number, conrmation key, and last upgrade date:
1 Click from the toolbar on any screen.
2 Select About Bionic Navigator from the drop-down menu.
3 Click to exit.
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Managing System Settings
Viewing the System Settings
Managing System Settings
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The System screen is used to view and adjust system-wide default program settings, including
pulse width, rate, ramp time, Remote Control language, and the preference for how patients’
names are displayed. Defaults will be used as a starting point for programming a patient for the rst
time.
To view the System settings:
1 Click in the toolbar on any screen.
2 To exit, click to save your changes or to exit without saving.
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Adjusting the Default Pulse Width
To adjust the default pulse width:
1 Click in the toolbar on any screen.
2 Click the buttons next to the Default Pulse Width eld to achieve the desired pulse
width.
The range of available pulse widths is 10 μs to 450 μs.
3 Click to save your changes or to exit without saving.
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Managing System Settings
Adjusting the Default Rate
To adjust the default rate:
1 Click in the toolbar on any screen.
2 Click the buttons next to the Default Rate eld to achieve the desired rate.
The range of available rates is 2 Hz to 255 Hz.
3 Click to save your changes or to exit without saving.
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Adjusting the Default Ramp Time
To adjust the default ramp time:
1 Click in the toolbar on any screen.
2 Click the buttons next to the Default Ramp Time eld to achieve the desired ramp
time.
The range of available ramp times is 1 s to 10 s.
3 Click to save your changes or to exit without saving.
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Managing System Settings
Selecting the Default Remote Control Language
To select the default Remote Control language:
1 Click in the toolbar on any screen.
2 Click the down arrow next to the Remote Language eld.
3 Select the desired language from the drop-down menu.
Available languages include English, German, Dutch, French, Italian, Spanish, and Iconic.
4 Click to save your changes or to exit without saving.
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Setting the Patient Name Display Preference
To set the default patient name display format preference:
1 Click in the toolbar on any screen.
2 Click the button next to the desired patient name display format.
(Last Name, First Name or First Name Last Name).
3 Click to save your changes or to exit without saving.
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Addendum
Addendum
Additional notes on the Clinician Programmer Software:
PROGRAMMING
After changing stimulation settings in PROGRAM, always navigate to the REMOTE screen and
SAVE the latest changes to a program slot.
REPORTS
The patient report may display an incorrect ramp time value. The same ramp time is displayed
for all programs in the report, when in the Patient Options menu, the “Set As Patient Defaults” is
checked. This may not be the correct ramp time value for all individual programs on the report. The
ramp time value in the “Patient Options” window always displays the correct ramp time value for all
individual programs.
GENERAL NOTES
If “No Stimulator Detected” is displayed, do the following:
● Verify that everything is still connected and aligned.
● Check to see that the Remote Control is still in CP Mode.
● Press “START.”
SYNC DATA
When data is synced between two Clinician Programmer systems that have different system times
set, there can be overlap of data in the reports. Check and update system clocks before syncing.
If no Clinic Patients are displayed when attempting to sync, exit by selecting the “Done” button and
select “Sync Data” again.
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Vercise™ DBS Programming Manual
BS EN 60601-1-2 Classication Information
Testing to demonstrate compliance of the Vercise™ System with the essential requirements and
other relevant provisions of Directive 1999/5/EC were leveraged from testing performed on the
Precision™ SCS System.
• Internally powered
• Continuous operation
• Ordinary equipment
• Class II
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Table 1: Guidance and manufacturer’s declaration – electromagnetic emissions
The Vercise System is intended for use in electromagnetic environment specied below. The
customer or the user of the Vercise System should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1 The Vercise System uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage uctuations/ icker
Class B The Vercise System is suitable for use in all
establishments, including domestic establishments
Not Applicable
and those directly connected to the public low
voltage power supply network that supplies
Not Applicable
buildings used for domestic purposes.
emissions
IEC 61000-3-3
Hereby, Boston Scientic declares that the Vercise System is in compliance with the essential requirements and
other relevant provisions of Directive 1999/5/EC.
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Troubleshooting
Troubleshooting
There are no user serviceable parts. If you have a specic question or issue and need to contact
Boston Scientic, choose your locality from the following list:
Argentina
T: +5411 4896 8556 F: +5411 4896 8550
Australia / New Zealand
T: 1800 676 133 F: 1800 836 666
Austria
T: +43 1 60 810 F: +43 1 60 810 60
Balkans
T: 0030 210 95 37 890 F: 0030 210 95 79 836
Belgium
T: 080094 494 F: 080093 343
Brazil
T: +55 11 5853 2244 F: +55 11 5853 2663
Bulgaria
T: +359 2 986 50 48 F: +359 2 986 57 09
Canada
T: +1 888 359 9691 F: +1 888 575 7396
Chile
T: +562 445 4904 F: +562 445 4915
China – Beijing
T: +86 10 8525 1588 F: +86 10 8525 1566
Hong Kong
T: +852 2960 7100 F: +852 2563 5276
Hungary
T: +36 1 456 30 40 F: +36 1 456 30 41
India – Bangalore
T: +91 80 5112 1104/5 F: +91 80 5112 1106
India – Chennai
T: +91 44 2648 0318 F: +91 44 2641 4695
India – Delhi
T: +91 11 2618 0445/6 F: +91 11 2618 1024
India – Mumbai
T: +91 22 5677 8844 F: +91 22 2617 2783
Italy
T: +39 010 60 60 1 F: +39 010 60 60 200
Korea
T: +82 2 3476 2121 F: +82 2 3476 1776
Malaysia
T: +60 3 7957 4266 F: +60 3 7957 4866
Mexico
T: +52 55 5687 63 90 F: +52 55 5687 62 28
en
China – Guangzhou
T: +86 20 8767 9791 F: +86 20 8767 9789
China – Shanghai
T: +86 21 6391 5600 F: +86 21 6391 5100
Colombia
T: +57 1 629 5045 F: +57 1 629 5082
Czech Republic
T: +420 2 3536 2911 F: +420 2 3536 4334
Denmark
T: 80 30 80 02 F: 80 30 80 05
Finland
T: 020 762 88 82 F: 020 762 88 83
France
T: +33 (0) 1 39 30 97 00 F: +33 (0) 1 39 30 97 99
Germany
T: 0800 072 3301 F: 0800 072 3319
Greece
T: +30 210 95 42401 F: +30 210 95 42420
Middle East / Gulf / North Africa
T: +961 1 805 282 F: +961 1 805 445
The Netherlands
T:+31 30 602 5555 F: +31 30 602 5560
Norway
T: 800 104 04 F: 800 101 90
Philippines
T: +63 2 687 3239 F: +63 2 687 3047
Poland
T: +48 22 435 1414 F: +48 22 435 1410
Portugal
T: +351 21 3801243 F: +351 21 3801240
Singapore
T: +65 6418 8888 F: +65 6418 8899
South Africa
T: +27 11 840 8600 F: +27 11 463 6077
Spain
T: +34 901 11 12 15 F: +34 902 26 78 66
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Sweden
T: 020 65 25 30 F: 020 55 25 35
Switzerland
T: 0800 826 786 F: 0800 826 787
Taiwan
T: +886 2 2747 7278 F: +886 2 2747 7270
Thailand
T: +66 2 2654 3810 F: +66 2 2654 3818
Turkey – Istanbul
T: +90 216 464 3666 F: +90 216 464 3677
Uruguay
T: +59 82 900 6212 F: +59 82 900 6212
UK & Eire
T: +44 844 800 4512 F: +44 844 800 4513
Venezuela
T: +58 212 959 8106 F: +58 212 959 5328
NOTE: Phone numbers and fax numbers may change.
For the most current contact information, please refer to our website at
http://www.bostonscientic-international.com/ or write to the following address:
Boston Scientic Neuromodulation
25155 Rye Canyon Loop
Valencia, CA 91355, USA
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Addendum
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fr
Manuel de programmation Vercise™ DBS
Marque commerciale
Toutes les marques commerciales sont la propriété de leurs détenteurs respectifs.
Garanties
Boston Scientic Corporation se réserve le droit de modier sans préavis les informations relatives à ses
produits an d'améliorer leur abilité ou capacités de fonctionnement.
Informations complémentaires
Pour les indications, les contre-indications, les mises en garde, les précautions, un résumé des
effets indésirables, la stérilisation, la mise au rebut des composants, le stockage et la manipulation
et les informations relatives à la garantie, reportez-vous aux Informations destinées aux médecins
adaptées à votre système DBS Vercise. Pour des informations relatives à des dispositifs
spéciques non incluses dans ce manuel ou relatives aux symboles des étiquettes, reportez-vous
aux Indications d'utilisation appropriées concernant votre système DBS Vercise répertoriées dans
votre Guide de référence DBS.
Références des produits
Numéro de modèle Description
DB-7153-203 Programmateur du système Vercise destiné aux médecins
DB-7153-203-R Programmateur du système Vercise destiné aux médecins
(reconditionné)
DB-7153-N1 Programmateur du système DBS Vercise destiné aux médecins
DB-7153-N1-R Programmateur du système DBS Vercise destiné aux médecins
(reconditionné)
DB-1110-C Kit IPG Vercise
DB-5110-C ETS Vercise
DB-5212-C Télécommande Vercise
DB-5500-C Kit de télécommande Vercise
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Table des matières
Glossaire ........................................................................................................................................ 81
Introduction .................................................................................................................................... 83
Utilisation prévue ................................................................................................................. 83
Installation ...................................................................................................................................... 84
Connecter la télécommande au Programmateur du médecin ............................................. 84
Associer une télécommande à un stimulateur ..................................................................... 86
Annuler l’association d’une télécommande à partir d’un stimulateur ................................... 88
Débuter une session ..................................................................................................................... 89
Accéder à l’écran de démarrage.......................................................................................... 89
Comprendre la barre d’outils ............................................................................................... 90
Comprendre les boutons communs ..................................................................................... 91
Démarrer une nouvelle session patient ............................................................................... 92
Créer un nouveau patient .................................................................................................... 93
Sélectionner un patient existant........................................................................................... 94
Gérer un prol de patient .............................................................................................................. 95
Saisir et modier des informations relatives au patient ....................................................... 95
Saisir des notes sur le patient.............................................................................................. 96
Consulter l’historique d’un dossier patient ........................................................................... 97
Congurer le système de SCP Vercise ........................................................................................ 98
Vérier la conguration du système de SCP Vercise .......................................................... 98
Modier les informations relatives aux sondes .................................................................... 99
Intervertir les sondes ......................................................................................................... 100
Tester les impédances ....................................................................................................... 101
Programmer le patient ................................................................................................................ 102
Caractéristiques programmables du stimulateur ............................................................... 102
Accéder à l’écran Programming (Programmation) ............................................................ 103
Choisir une zone ................................................................................................................ 104
Choisir des contacts .......................................................................................................... 105
Activer et désactiver la stimulation pour chaque zone....................................................... 107
Augmenter et diminuer l’amplitude .................................................................................... 108
Augmenter et diminuer la largeur d’impulsion ................................................................... 109
Augmenter et diminuer la fréquence...................................................................................110
Programmer plusieurs zones .............................................................................................. 111
Dénir la plage des amplitudes...........................................................................................113
Comprendre les avertissements liés à la densité de charge ..............................................115
Nommer les zones ..............................................................................................................116
Nommer le programme .......................................................................................................117
Activer et désactiver la stimulation globale .........................................................................118
Ajuster les options du patient..............................................................................................119
Gérer les programmes ................................................................................................................ 123
Accéder à l’écran Remote Control (Télécommande) ......................................................... 123
Comprendre les emplacements pour programme ............................................................. 124
Enregistrer un programme ................................................................................................. 125
Activer un programme depuis la télécommande ............................................................... 126
Prévisualiser un programme depuis la télécommande ...................................................... 127
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Supprimer un programme .................................................................................................. 128
Vérier le niveau de charge de la batterie du stimulateur et afcher la durée de
rechargement estimée ....................................................................................................... 129
Gérer les programmes dans la base de données des programmes ....................................... 130
Consulter les programmes dans la base de données des programmes ........................... 130
Activer un programme depuis la base de données des programmes ............................... 131
Prévisualiser un programme depuis la base de données des programmes ...................... 132
Supprimer un programme de la base de données des programmes ................................ 133
Créer des rapports ...................................................................................................................... 134
Choisir un rapport .............................................................................................................. 134
Rapport d’informations sur le patient ................................................................................. 135
Generic Report (Rapport générique) ................................................................................. 136
Patient List Report (Rapport contenant la liste des patients)............................................. 137
Clinical Outcomes Report (Rapport de résultats cliniques) ............................................... 138
Clinical Activity Report (Rapport d’activités cliniques) ....................................................... 139
Synchroniser des données ......................................................................................................... 140
Comprendre la fonction Synchronizing Data (Synchronisation de données) .................... 140
Installer une nouvelle carte du patient ............................................................................... 141
Synchroniser des données ............................................................................................... 142
Supprimer des dossiers patients ....................................................................................... 143
Utiliser des outils supplémentaires ........................................................................................... 144
Afcher les informations système ...................................................................................... 144
Sauvegarder les données et les journaux ........................................................................ 145
Mesurer les potentiels des champs ................................................................................... 146
Ajouter une sonde.............................................................................................................. 147
Activer et désactiver l’impédance automatique ................................................................. 148
Afcher les informations sur le Bionic Navigator ............................................................... 149
Gérer les paramètres système ................................................................................................... 150
Afcher les paramètres système ....................................................................................... 150
Ajuster la largeur d’impulsion par défaut ........................................................................... 151
Ajuster la fréquence par défaut.......................................................................................... 152
Ajuster la durée de montée par défaut .............................................................................. 153
Sélectionner la langue de la télécommande par défaut..................................................... 154
Dénir les préférences d’afchage des noms des patients ............................................... 155
Addenda ....................................................................................................................................... 156
Dépannage ................................................................................................................................... 158
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Glossaire
Glossaire
Amplitude
Courant affecté au cours de l’impulsion de stimulation, mesuré en milliampères (mA).
Anode
Électrode chargée positivement au cours de l’impulsion de stimulation (dans le contexte de la
neurostimulation).
Batterie
Composant du stimulateur qui stocke et distribue l’énergie au système implanté.
Base de données des programmes
Liste des programmes qui ont été enregistrés dans le stimulateur (c.-à-d., historique des
programmes).
Cathode
Électrode chargée négativement au cours de l’impulsion de stimulation (dans le contexte de la
neurostimulation).
fr
Chargeur
Dispositif externe utilisé pour recharger la batterie du stimulateur implanté.
Contact
Composant conducteur d’électricité sur la sonde ; une sonde comporte généralement plusieurs
contacts (parfois également nommés « électrodes »).
Durée de montée
Temps qu’il faut au stimulateur pour accroître la stimulation de 0 mA à l’amplitude programmée.
Fréquence (Frequency)
Voir Fréquence d’impulsion.
Fréquence d’impulsion
Nombre d’impulsions de courant électrique en une seconde, mesuré en Hertz (Hz) ou en
impulsions par seconde (pps).
Largeur d’impulsion
Durée de l’impulsion du courant électrique, mesurée en microsecondes (μs).
Options patient
Paramètres par défaut d’un patient donné, par opposition avec les paramètres système par défaut.
Programme
Paramètres de stimulation pouvant être actifs à un moment donné ; un programme peut comporter
jusqu’à 4 zones (voir Zone).
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Manuel de programmation Vercise™ DBS
Programmateur du médecin
Dispositif exécutant le logiciel Bionic Navigator™, utilisé pour congurer les paramètres de
stimulation.
Rechargement
Action de recharger la batterie implantée du stimulateur.
Sonde
Composée de ls isolés et de contacts, elle conduit l’électricité du stimulateur aux contacts dans
les tissus.
Zone
Ensemble de paramètres de stimulation et d’affectations de contacts appartenant à une sonde ; un
programme peut comporter jusqu’à 4 zones.
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Introduction
Introduction
fr
Bienvenue dans le Bionic Navigator™ de Boston Scientic.
Bionic Navigator est un programme logiciel utilisé pour dénir et ajuster les paramètres de
stimulation du système de SCP Vercise™. L’objectif de ce Manuel de programmation est
d’optimiser les bénéces du patient en offrant des informations et des instructions utiles aux
personnes qui utilisent le logiciel Bionic Navigator sur le Programmateur du médecin.
Les pages qui suivent vous initieront aux concepts de base : vous apprendrez ainsi comment
saisir des informations patient, programmer un patient et enregistrer des programmes de patient
sur la télécommande. Vous y découvrirez également des fonctions supplémentaires, comme la
création de rapports et la synchronisation de données.
Si vous rencontrez un quelconque problème avec le Bionic Navigator, veuillez vous reporter aux
sections Dépannage et Questions fréquemment posées.
Utilisation prévue
Bionic Navigator est un logiciel utilisé pour dénir et ajuster les paramètres de stimulation pour le
système de SCP Vercise.
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Manuel de programmation Vercise™ DBS
Installation
Connecter la télécommande au Programmateur du médecin
Le Programmateur du médecin communique avec le stimulateur au travers de la télécommande.
Le Programmateur du médecin est relié à la télécommande par le biais d’infrarouges (IR). La
télécommande utilise une liaison de radiofréquences (RF) pour communiquer avec le stimulateur.
Il est possible de charger des programmes sur le Programmateur du médecin an de prévisualiser,
activer et modier des paramètres de stimulation. Les programmes de stimulation peuvent
également être sauvegardés sur la télécommande.
ATTENTION : utilisez uniquement les composants du système de SCP Vercise™ avec le
Programmateur du médecin. Le non-respect de cette recommandation peut
engendrer une stimulation inappropriée.
ATTENTION : le CP n’est pas un équipement pour l’environnement patient tel que déni
par IEC 60601-1. Le CP et la personne utilisant le CP ne doivent pas être en
contact avec le patient pendant la programmation.
Pour connecter la télécommande au Programmateur du médecin :
1 Branchez le câble série USB dans un port USB du Programmateur du médecin.
2 Branchez l’extrémité série du câble série USB dans la partie correspondante de l’interface IR.
3 Insérez l’interface IR et la télécommande dans le support en plastique an que les fenêtres
IR soient bien alignées, comme illustré ci-dessous.
1 2 3
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Installation
4 Placez le patient à 45 cm (18 pouces) maximum de la télécommande et orientez la partie
la plus large de la télécommande de sorte à ce qu’elle soit parallèle à la partie la plus
large du stimulateur. Une bonne orientation garantira une communication able entre le
Programmateur du médecin et le stimulateur.
Remarque : un message s’afchera sur le Programmateur du médecin si la distance de
communication n’est pas satisfaisante.
5 Mettez le programmateur du médecin sous tension et ouvrez une session.
6 Cliquez sur l’icône du lanceur Vercise sur le bureau.
7 Sélectionnez l’icône du système DBS Vercise pour démarrer Bionic Navigator
Remarque : on peut aussi accéder à Vercise Navigator sur le même programmateur
destiné au médecin via le lanceur Vercise. Reportez-vous au Guide de
référence DBS Vercise pour des instructions sur l’application logicielle
à utiliser avec votre système de stimulation cérébrale profonde (DBS).
Reportez-vous au manuel Vercise Navigator fourni avec le produit pour
obtenir des instructions sur Vercise Navigator.
fr
Remarque : Bionic Navigator et Vercise Navigator ne peuvent pas s’exécuter
simultanément sur le même programmateur destiné au médecin.
8 Appuyez longuement sur le bouton P pour déverrouiller la télécommande.
Remarque : la télécommande doit être associée au stimulateur (reportez-vous à la section
Associer une télécommande à un stimulateur à la page 86).
9 Entrez dans l’écran du médecin de la télécommande en appuyant longuement et
simultanément sur les boutons et P.
10 Appuyez sur le bouton P pour sélectionner Mode CP (Mode PM).
La télécommande vous informe qu’elle est prête à communiquer avec le Programmateur du
médecin.
Une fois la télécommande à portée du stimulateur, le Programmateur du médecin détecte le
stimulateur et démarre la communication.
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Associer une télécommande à un stimulateur
Par associer, on entend congurer la télécommande de sorte à ce qu’elle communique avec un
stimulateur donné.
Pour associer une télécommande qui a déjà été associée à un autre stimulateur, vous devez
d’abord annuler l’association de la télécommande depuis le stimulateur d’origine (reportez-vous à
la section Annuler l’association d’une télécommande à partir d’un stimulateur à la page 88) puis
associer la télécommande au nouveau stimulateur.
Pour associer une télécommande à un stimulateur :
1 Appuyez longuement sur le bouton P pour déverrouiller la télécommande.
La télécommande vous demande si vous souhaitez l’associer à un stimulateur.
2 Positionnez la télécommande à 45 cm (18 pouces) maximum du stimulateur et orientez la
partie la plus large de la télécommande de sorte à ce qu’elle soit parallèle à la partie la plus
large du stimulateur.
3 Appuyez sur le bouton P pour associer la télécommande au stimulateur, ou annulez en
appuyant sur le bouton .
4 Conrmez l’association en appuyant sur le bouton P, ou annulez en appuyant sur le
bouton .
Si les programmes sont
enregistrés dans...
La télécommande
Le stimulateur
La télécommande
Le stimulateur
La télécommande
Le stimulateur
Alors...
La télécommande télécharge automatiquement les programmes à
partir du stimulateur.
La télécommande télécharge automatiquement les programmes à
partir du stimulateur.
La télécommande vous demande si vous souhaitez télécharger les
programmes de la télécommande dans le stimulateur.
Saisissez le mot de passe A-B-C pour télécharger les programmes
de la télécommande dans le stimulateur.
La télécommande
Le stimulateur
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La télécommande est immédiatement associée au stimulateur.
Page 93
Installation
Si les programmes sont
enregistrés dans...
La télécommande
Le stimulateur
d’essai externe
La télécommande
Le stimulateur
d’essai externe
La télécommande
Le stimulateur
d’essai externe
Alors...
La télécommande vous invite à effacer les programmes du
stimulateur d’essai externe.
Ensuite, la télécommande vous demande si vous souhaitez
télécharger les programmes de la télécommande dans le
stimulateur d’essai externe.
Saisissez le mot de passe A-B-C pour télécharger les programmes
de la télécommande dans le stimulateur d’essai externe.
La télécommande vous invite à effacer les programmes du
stimulateur d’essai externe.
La télécommande vous demande si vous souhaitez télécharger
les programmes de la télécommande dans le stimulateur d’essai
externe.
Saisissez le mot de passe A-B-C pour télécharger les programmes
de la télécommande dans le stimulateur d’essai externe.
fr
La télécommande
Le stimulateur
d’essai externe
La télécommande est immédiatement associée au stimulateur
d’essai externe.
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Manuel de programmation Vercise™ DBS
Annuler l’association d’une télécommande à partir d’un
stimulateur
Pour annuler l’association d’une télécommande à partir d’un stimulateur :
1 Appuyez longuement sur le bouton P pour déverrouiller la télécommande.
2 Entrez dans l’écran du médecin de la télécommande en appuyant longuement et
simultanément sur les boutons et P.
3 Faites déler le menu pour sélectionner Clear Link (Effacer lien) en appuyant sur le
bouton P.
4 Conrmez l’effacement du lien en appuyant sur le bouton P, ou annulez en appuyant sur
le bouton .
fr
5 Saisissez le mot de passe A-B-C.
Remarque : pour rétablir l’association de la télécommande, reportez-vous à la section
Associer une télécommande à un stimulateur à la page 86.
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Débuter une session
Débuter une session
Accéder à l’écran de démarrage
L’écran de démarrage s’ouvre au lancement du logiciel Bionic Navigator. Pour accéder à l’écran de
démarrage à un autre moment, cliquez sur l’icône (Démarrer) située en haut à droite de
n’importe quel écran.
fr
Si la télécommande du patient est reliée et positionnée de sorte à communiquer avec le
stimulateur, alors le système détecte automatiquement le stimulateur de SCP.
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Comprendre la barre d’outils
La barre d’outils se trouve en haut de chaque écran du logiciel Bionic Navigator. La barre d’outils
permet d’accéder aux diverses fonctions dénies dans le tableau ci-dessous, puis décrites plus en
détail dans plusieurs sections du présent manuel.
Cliquez sur... pour...
Créer des rapports, notamment des rapports d’informations sur le
patient, des rapports génériques, des rapports contenant la liste
des patients, des rapports de résultats cliniques et des rapports
d’activités cliniques.
Synchroniser les données entre le Programmateur du médecin et
une carte de patient (pour transférer des données).
Accéder à divers outils, notamment aux informations système,
sauvegarder des données, activer des mesures de l’impédance
automatique, accéder à l’EGL-Scan, et consulter des informations
sur le Bionic Navigator.
Consulter et modier des réglages système par défaut.
Terminer la session en cours et redémarrer le Bionic Navigator.
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Débuter une session
Comprendre les boutons communs
Les boutons communs sont répartis tout autour de chaque écran du logiciel Bionic Navigator. Ces
boutons vous permettent d’accéder rapidement et facilement aux écrans communs ou de réaliser
des actions courantes. La fonction de ces boutons est dénie dans le tableau ci-dessous ; ces
boutons sont par ailleurs décrits plus en détail dans plusieurs sections du présent manuel.
Cliquez sur... pour...
Accéder à l’écran Prole (Prol).
Accéder à l’écran Conguration.
Activer la stimulation (s’applique à toutes les zones dont l’Amplitude
est dénie sur une valeur supérieure à zéro).
Désactiver la stimulation.
Accéder à l’écran Programming (Programmation).
Accéder à l’écran Remote Control (Télécommande).
fr
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Démarrer une nouvelle session patient
Le logiciel Bionic Navigator démarre automatiquement une nouvelle session à son lancement.
Lorsque le logiciel est déjà ouvert, vous pouvez démarrer une nouvelle session ou redémarrer le
logiciel Bionic Navigator en utilisant la fonction Start (Démarrer).
Pour utiliser la fonction Start (Démarrer), cliquez sur l’icône (Démarrer) que vous trouverez
dans la barre d’outils de n’importe quel écran.
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Débuter une session
Créer un nouveau patient
Pour créer un nouveau patient :
1 Cliquez sur la èche pointant vers le bas située à droite du menu déroulant Patient.
2 Sélectionnez New Patient (Nouveau Patient).
L’écran Prole (Prol) s’afche automatiquement.
3 Renseignez les informations relatives au patient.
Pour de plus amples informations sur l’écran Prole (Prol), reportez-vous à la section
Gérer un prol de patient à la page 95.
4 Cliquez sur (Terminer) pour enregistrer les informations.
L’écran Start (Démarrer) s’afche automatiquement.
5 Cliquez sur la èche pointant vers le bas située à droite du menu déroulant Reason for Visit
(Objet de la visite).
6 Sélectionnez l’objet de la visite qui convient.
fr
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Sélectionner un patient existant
Le Programmateur du médecin reconnaît automatiquement un patient dès lors que vous avez déjà
associé le Programmateur du médecin à son matériel.
Pour sélectionner un patient existant :
1 Cliquez sur la èche pointant vers le bas située à droite du menu déroulant Patient.
2 Sélectionnez le patient approprié dans la liste alphabétique.
3 Cliquez sur la èche pointant vers le bas située à droite du menu déroulant Reason for Visit
(Objet de la visite).
4 Sélectionnez l’objet de la visite du patient.
La session du patient commence alors. Vous pouvez maintenant accéder à d’autres écrans en
cliquant sur les boutons appropriés à l’écran.
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