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Vercise DBS Remote Control 3

Boston Scientific Vercise DBS Remote Control 3, DB-5552-S, DB-5552-1 Directions For Use Manual

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Vercise™ DBS Remote Control 3
Directions for Use
CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician.
92104389-01
Content: 92116332 REV B
Trademarks
All trademarks are the property of their respective holders.
Guarantees
Boston Scientic Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve
their reliability or operating capacity.
Additional Information
For indications, contraindications, warnings, precautions, adverse events summary, sterilization, component disposal, and storage and handling, refer to the Information for Prescribers DFU. For other device-specic information not included in this manual or labeling symbols, refer to the appropriate DFU as listed on your DBS Reference Guide.
Technical Support
There are no user serviceable parts. If you have a specic question or issue, please contact your sales representative or call (833) DBS-INFO or (833) 327-4636.
Product Model Numbers
Model Number Description
DB-5552-1 Vercise DBS Remote Control 3 Kit DB-5250-S Vercise DBS Remote Control 3
NM-6210 Remote Control Holster NM-6315 USB Power Supply, Remote Control, Universal NM-6310 USB Power Supply, Remote Control, North America
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Table of Contents
Description ............................................................................................................................................... 1
Remote Control Features ........................................................................................................................2
Basic Operation ....................................................................................................................................... 2
Unlocking the Remote control ..............................................................................................................2
Turning Stimulation ON/OFF ...............................................................................................................3
Selecting Your Language/Screen Preference ...................................................................................... 3
The Home Screen ................................................................................................................................3
Accessing Additional Options from the Main Menu .............................................................................4
Accessing the Main Menu ....................................................................................................................4
Program Selection and Activation ........................................................................................................ 5
Restoring Programs ............................................................................................................................. 6
Changing Stimulation Level ................................................................................................................. 7
Accessing System Settings ....................................................................................................................8
Remote Settings ..................................................................................................................................8
System Info ........................................................................................................................................ 11
Accessing the Clinician Menu .............................................................................................................. 13
Stimulator Search ..............................................................................................................................14
Impedances .......................................................................................................................................16
Reset Stimulator ................................................................................................................................17
Exit Clinician Mode ............................................................................................................................18
Remote Control Battery ........................................................................................................................18
Remote Control Battery Status .......................................................................................................... 18
Recharging the Remote Control ........................................................................................................18
End of Programmed Service (For Non-rechargeable Stimulators Only) .......................................... 19
ERI (Elective Replacement Indicator) Screen (For Non-rechargeable Stimulator Only) ................20
End of Battery Life Screen (For Non-rechargeable Stimulator Only) ............................................... 20
Troubleshooting ....................................................................................................................................21
Telemetry Help ................................................................................................................................... 21
No Program to Run Screen................................................................................................................22
Invalid Program Screen .....................................................................................................................22
Unsupported Stimulator Screen .........................................................................................................23
System Settings Reset Screen .......................................................................................................... 23
Stimulator Error Screen .....................................................................................................................24
Remote Error Screen ......................................................................................................................... 24
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Stimulator Low Battery Screens (For rechargeable Vercise Gevia Stimulator only) .......................... 24
Icon Description and Index ...................................................................................................................26
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Description
Description
The Remote Control is a hand-held device that communicates with the Stimulator through a radio frequency (RF) telemetry link. The Remote Control functions include the following:
• Linking/De-Linking to a Stimulator
• Turning stimulation ON and OFF
• Increasing stimulation amplitude
• Changing and restoring Programs
• Accessing Clinician Menu Options
• Customizing Remote Control settings: language, volume, brightness
Cautions
• Keep the Remote Control dry. It should not be exposed to moisture.
• Do not connect the Remote Control USB port to any other device except to the Remote Control
charger provided with it.
• Keep the Remote Control away from pets, pests and children to avoid damage to the device.
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Remote Control Features
1. Screen: displays all menus, icons, and messages.
2. Lock/Unlock Button : unlocks the Remote Control from sleep mode.
3. Programs Button : displays the Programs menu.
4. Home Button : displays the Home screen.
5. Stimulation Button : Turns stimulation ON or
OFF.
6. Minus Button : Decreases selected
parameter.
7. Plus Button : Increases selected parameter .
8, 9. Navigation Buttons and : allow scrolling through a selected menu.
10, 11. Navigation Buttons and : make a
selection.
12. Navigation Button : returns to the previous screen.
13. USB Port (not shown): allows recharging of the
Remote Control with the USB power supply.
The Remote Control has an average communication range of 22 inches (55.9 cm) with the non­rechargeable VerciseTM PC Stimulator and an average communication range of 36 inches (91.4cm) with the rechargeable Vercise GeviaTM Stimulator. When using the Remote Control, avoid common sources of interference, such as televisions and computer monitors. For additional telemetry information, see
the Telemetry Help section.
Basic Operation
Unlocking the Remote control
The Remote Control goes into idle (or sleep) mode when not in use. It can be reactivated by pressing the Lock/Unlock button on the right side of the Remote Control.
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Basic Operation
Turning Stimulation ON/OFF
After unlocking the Remote Control, press the Stimulation ON/OFF button to turn the Stimulator ON or OFF.
Selecting Your Language/Screen Preference
The Remote Control allows you to choose either an iconic screen or a text screen in one of the languages provided. See the Languages section for additional instructions.
Note: Throughout this manual, both the English text and the iconic screens are shown.
The Home Screen
After unlocking the Remote Control, the Home screen will appear if the Remote Control was previously linked to a Stimulator. The Home screen shows the number of the active program, stimulation status (ON/OFF), navigation to the Main Menu, and the Stimulator battery level for Rechargeable Stimulators. It also shows the battery level of the Remote Control (see Remote Control Battery section). The Home screen can be accessed from any other screen by pressing the Home button.
1. Press the Home button on the left side of the Remote Control to view the Home screen.
Home Screen for Rechargeable Stimulator
Note: When the Remote Control connects to a rechargeable Stimulator, it will display the current
battery level of the Stimulator on the Home screen.
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Home Screen for Non-Rechargeable Stimulator
Note: When the Remote Control connects to a non-rechargeable Stimulator, the battery level of the
Stimulator will not be displayed on the screen.
Accessing Additional Options from the Main Menu
The Main Menu gives you access to the following options:
• Programs
• Stimulation
• System Settings
Accessing the Main Menu
1. Press the button on the left side of the Remote Control to display the Home screen.
2. From the Home screen, press the right arrow button to select the Main Menu.
Note: When the Stimulator has no programs saved on it, the Main Menu will only display the System
Settings option.
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Accessing Additional Options from the Main Menu
Program Selection and Activation
A stimulation program is a set of stimulation parameters that determine the patient’s therapy. A program may apply stimulation to as many as four independent stimulation elds or areas, depending on how the program is set up. For example, one area may correspond to a right brain target, while another area may correspond to a left brain target. The Remote Control can store up to four programs – numbered 1 through 4 – for the patient to select and activate at any time.
1. Press the button on the left side of the Remote Control to display the Programs screen.
Note: You can also navigate to the Programs menu from the Main Menu. Refer to the Accessing the
Main Menu section for additional instructions.
2. Select Change Program.
3. Press the Up or Down Arrow buttons to navigate to the desired program.
4. Press the Right Arrow button to select the program.
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Restoring Programs
If after changing a program, you decide that you want to revert the program back to its clinic settings, you can do so by restoring the program.
1. Press the button on the left side of the Remote Control.
or
From the Main Menu screen, select Programs.
Select Restore to Clinic Settings. The Restore screen displays a list of programs to restore.
2. Select the program you want to restore. The Restore Conrmation screen displays.
3. Select Yes to restore the program to the clinic settings.
or
Select No to cancel the action.
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Accessing Additional Options from the Main Menu
Changing Stimulation Level
A program may apply stimulation to one area, or up to four areas, depending on how the program is set up. The stimulation level for an area may be changed if allowed by the clinician using the Remote
Control.
1. From the Main Menu: Select Stimulation.
2. Use the navigation buttons ( ) to select the desired area.
3. Press the Minus button to decrease the level of stimulation.
4. Press the Plus button to increase the level of stimulation.
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Accessing System Settings
From the Main Menu:
Select System Settings to display the System Settings menu.
System Settings Menu for Rechargeable Vercise Gevia Stimulator
System Settings Menu for Non-Rechargeable Stimulator
Remote Settings
The Remote Settings option allows you to adjust the alert volume and screen brightness, and to select your language preference.
From the System Settings menu:
1. Select Remote Settings to display the Remote Settings menu.
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Alert Volume
From the Remote Settings menu:
1. Select Alert Volume.
Accessing System Settings
2. Press the Minus button to decrease the alert volume
3. Press the Plus button to increase the alert volume.
Screen Brightness
From the Remote Settings menu:
1. Select Screen Brightness.
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2. Press the Minus button to decrease the brightness
3. Press the Plus button to increase the brightness.
Languages
The Remote Control allows you to congure your system to display one the following:
• Text screen in one of the available languages
• Iconic screen From the Remote Settings menu:
1. Select Languages.
2. Select the desired language, such as English or iconic display.
The Languages Conrmation screen displays to conrm your selection.
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Accessing System Settings
System Info
The System Info menu gives you the option of viewing information regarding the Remote Control or the Stimulator.
From the System Settings menu, select System Info.
Remote Info
Select Remote Info to view the Remote Info screen.
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Serial Number
Model Number
Boot Version
Firmware Version
The Remote Info screen displays the following information:
• Serial Number
• Model Number
• Boot Version
• Firmware Version
...
Select More to view additional Remote Info, such as LCD Boot Version and LCD Firmware.
LCD Boot Version
LCD Firmware
Stimulator Info
Select Stimulator Info to view the Stimulator Info screen.
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Serial Number
Model Number
Boot Version
Firmware Version
The Stimulator Info screen displays the following information:
• Serial Number
• Model Number
• Boot Version
• Firmware Version
Accessing the Clinician Menu
Accessing the Clinician Menu
The Clinician Menu allows you to link to a Stimulator, clear the link to a Stimulator, check impedances, and reset the Stimulator. To enter the Clinician Menu you must enter a password. Contact your Boston Scientic representative for the Clinician Password.
From the System Settings menu:
1. Select the Clinician Menu. The Password screen displays.
_ _ _ _
A B C D E F G H I
J K L M N O P Q R
S T U V W X Y Z
0 1 2 3 4 5 6 7 8 9
Enter
Cancel
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2. Use the Navigation buttons to enter your password.
Or
Use the Navigation buttons to cancel.
If the password is incorrect, the Invalid Password screen displays. If the password is correct, the Clinician Menu displays.
Note: If the Remote Control is not linked to a Stimulator, the Stimulator Search option displays on the
Clinician Menu instead of the Clear Link option.
Stimulator Search
The Clinician Menu allows you to search for a Stimulator and link to it.
From the Clinician Menu:
1. Select Stimulator Search. The Stimulator Search screen displays.
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Accessing the Clinician Menu
2. If the desired Stimulator has not been located, select Rescan.
3. Select the Stimulator that you wish to link to. The Link to Stimulator ? ###### screen displays.
4. Select Yes to link to the Stimulator.
or
Select No to cancel the action.
Clear Link
If the Remote Control is linked to a Stimulator, the Clear Link option displays on the Clinician Menu.
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From the Clinician Menu:
1. Select Clear Link. The Clear Link to Stimulator? screen displays.
2. Select Yes to clear the link to the Stimulator.
or
Select No to cancel the action.
Impedances
You can use the Remote Control to check impedances.
From the Clinician Menu:
1. Select Impedances. An impedance measurement is taken and the Impedances screen is
displayed.
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Accessing the Clinician Menu
When an impedance measurement is taken, impedances are assessed between a contact and the case (monopolar), and between pairs of contacts (bipolar). A green square indicates that impedance is within the acceptable range. A yellow dot with a question mark indicates that impedance is outside of the acceptable range.
Monopolar impedance values can be displayed by pressing the Down Arrow button from the Impedances screen.
2. Select Measure to check impedances again.
3. Select Back to go back to the Clinician Menu.
Reset Stimulator
You can use the Remote Control to reset the Stimulator.
From the Clinician Menu:
Select Reset Stimulator. The Reset Stimulator? screen displays.
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4. Select Yes to reset the Stimulator
or
Select No to cancel the action.
Exit Clinician Mode
From the Clinician Menu, select Exit Clinician Mode. The System Settings screen displays.
Remote Control Battery
Remote Control Battery Status
The icon at the top right of the Home screen indicates the charge level of the Remote Control battery. The Remote Control will display messages reminding you to recharge the Remote Control if the battery power is low.
Recharging the Remote Control
Recharge the Remote Control battery by connecting the remote control to the USB power supply provided with the Remote Control. The Remote Control battery has a typical service life of 400 charging
cycles.
5. Press the Right Arrow button to navigate to the Main Menu.
6. Select System Settings .
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End of Programmed Service (For Non-rechargeable Stimulators Only)
End of Programmed Service (For Non-rechargeable Stimulators Only)
The non-rechargeable Stimulator software has been programmed to end service after a dened period. When the non-rechargeable Stimulator is within approximately 180 days of the end of its programmed period, the Remote Control will display the following on-screen message.
Press to clear the message. The message will reappear approximately weekly until the end of the non-rechargeable Stimulator’s programmed period is reached. When the end of its programmed period is reached, the Remote Control will display the following on-screen message.
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ERI (Elective Replacement Indicator) Screen (For Non-rechargeable Stimulator Only)
This screen displays when the implanted non-rechargeable Stimulator is nearing end of service. Changes made to the stimulation will not be saved, and stimulation will not be available soon. Batteries that have lasted one year or more without entering ERI mode will have a minimum of four weeks between entering ERI mode and reaching end of battery life. Patients should be advised to contact their physician to report this message screen. Press to clear this information screen. This screen will appear whenever the Remote Control is activated.
End of Battery Life Screen (For Non-rechargeable Stimulator Only)
This screen displays when the battery of the implanted non-rechargeable Stimulator is fully depleted. Stimulation is not available. Patients should be advised to call their physician when this message
appears.
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Troubleshooting
?
?
Troubleshooting
Telemetry Help
Common sources of interference, such as televisions and computer monitors, can affect wireless communication. You will continue to have access to the Remote Control menus even if the Remote Control is outside its effective communication range. If you enter a command to change your settings or programs while the Remote Control is outside of its effective communication range, you will have several seconds to move the Remote Control within range of the Stimulator to send the command. After the command is received by the Stimulator, the Remote Control will make a double-beep then display the requested change on the screen. If the Remote Control is unable to communicate with the Stimulator, the Telemetry Error message will appear:
Telemetry Error
Communication
Failed
Retry
Telemetry Help
?
SelectCancel
To retry communication with the Stimulator – this resends the last command – select Retry . To cancel communication and return to the screen, press .
The Telemetry Help tool is also available to assist you in improving communication between the Remote Control and the Stimulator. To use the Telemetry Help tool, select Telemetry Help
. The
following screen will be displayed:
Test the Remote
at Dierent
Positions
Press to Exit
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The telemetry bars indicate the strength of wireless communication. The number of bars will change depending on the distance and orientation of the Remote Control from the Stimulator. This tool will continue to measure the strength of communication for 30 seconds or until is pressed.
No Program to Run Screen
This screen is displayed when the Stimulator has no programs to run.
P
No Program
to Run
Press to continue
P
0
Invalid Program Screen
This screen is displayed when the Stimulator attempts to run an invalid program.
P
P
Invalid
Program
P
?
Press to continue
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Troubleshooting
Unsupported Stimulator Screen
This screen is displayed when the Remote Control detects an incompatible Stimulator.
Unsupported
Stimulator
?
?
Press to continue
System Settings Reset Screen
This screen is displayed when the Remote Control experiences an error and a reset of the Remote Control is required. Press to continue. Programs will not be deleted, but all system settings (for example, language and volume settings) will be restored to the default factory settings.
System Settings
Reset
Press to continue
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Stimulator Error Screen
This screen is displayed when there is a non-critical Stimulator error. Press to acknowledge the message and continue.
Stimulator
Error
Press to continue
Remote Error Screen
This screen is displayed when there is a critical error on the Remote Control, which makes the Remote Control unusable. Please contact Boston Scientic to order a replacement Remote Control.
Remote
Error
Press to continue
Stimulator Low Battery Screens (For rechargeable Vercise Gevia Stimulator only)
The Remote Control will display the following messages reminding you to recharge the Stimulator if the battery power is low.
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Troubleshooting
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Icon Description and Index
A
Alert Volume 9
C
Change Program 5
Clear Link 14, 15, 16
Clinician Menu 13, 14, 15, 16, 17, 18
H
Home 2, 3, 4, 18
L
Languages 3, 10
M
Main Menu 3, 4, 5, 6, 7, 8, 18
N
Navigation 2, 3, 7, 14
P
Program 2, 4, 5, 6
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R
Remote Information 11, 12
Rescan 15
S
Icon Description and Index
Remote Battery 18
Restore to Clinic Settings 6
Retry 21
Screen Brightness 8, 9
Stimulation Area 4, 7
Stimulation OFF 2, 3
Stimulation ON 2, 3
Stimulator 3, 14, 22, 23, 24, 25
Stimulator Information 12, 13
System Info 11
System Settings 4, 8, 11, 13, 18
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Legal Manufacturer
AUS
Australian Sponsor
EU Authorized
Boston Scientic Neuromodulation Corporation 25155 Rye Canyon Loop Valencia, CA 91355 USA (866) 789-5899 in US and Canada (661) 949-4000, (661) 949-4022 Fax
(866) 789-6364 TTY
www.bostonscientic.com Email: neuro.info@bsci.com
Address
Boston Scientic (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1800 676 133 Free Fax 1800 836 666
© 2018 Boston Scientic Corporation
Representative
Boston Scientic Limited Ballybrit Business Park Galway, Ireland T: +33 (0) 1 39 30 97 00 F: +33 (0) 1 39 30 97 99
or its afliates. All rights reserved.
92104389-01 2018-07
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