Boston Scientific Vercise DBS Remote Control 3 Directions For Use Manual
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Boston Scientific Vercise DBS Remote Control 3 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

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Summary of Contents for Boston Scientific Vercise DBS Remote Control 3

  • Page 1 Vercise™ DBS Remote Control 3 Directions for Use 92104389-01 Content: 92116332 REV B CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician.
  • Page 2 Trademarks All trademarks are the property of their respective holders. Guarantees Boston Scientific 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.

  • Page 3: Table Of Contents

    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...
  • Page 4 Vercise ™ DBS Remote Control 3 Directions for Use Stimulator Low Battery Screens (For rechargeable Vercise Gevia Stimulator only) ......24 Icon Description and Index ........................26 Vercise™ DBS Remote Control 3 Directions for Use 92104389-01 iii of iii...

  • Page 5: Description

    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 •...

  • Page 6: Remote Control Features

    Vercise ™ DBS Remote Control 3 Directions for Use 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.

  • Page 7: Turning Stimulation On/Off

    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.

  • Page 8: Accessing Additional Options From The Main Menu

    Vercise ™ DBS Remote Control 3 Directions for Use 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: •...

  • Page 9: Program Selection And Activation

    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 fields or areas, depending on how the program is set up.

  • Page 10: Restoring Programs

    Vercise ™ DBS Remote Control 3 Directions for Use 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.

  • Page 11: Changing Stimulation Level

    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.

  • Page 12: Accessing System Settings

    Vercise ™ DBS Remote Control 3 Directions for Use Accessing System Settings Main Menu: From the System Settings to display the System Settings menu. Select 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.
  • Page 13 Accessing System Settings Alert Volume From the Remote Settings menu: Alert Volume. 1. Select 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.
  • Page 14 Vercise ™ DBS Remote Control 3 Directions for Use 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 configure your system to display one the following: •...

  • Page 15: System Info

    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, s elect System Info. Remote Info Remote Info to view the Remote Info screen. Select Vercise™...
  • Page 16 Vercise ™ DBS Remote Control 3 Directions for Use 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...

  • Page 17: Accessing The Clinician Menu

    Accessing the Clinician Menu 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 The Clinician Menu allows you to link to a Stimulator, clear the link to a Stimulator, check impedances, and reset the Stimulator.

  • Page 18: Stimulator Search

    Vercise ™ DBS Remote Control 3 Directions for Use 2. Use the Navigation buttons to enter your password. 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.
  • Page 19 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. Select No to cancel the action.

  • Page 20: Impedances

    Vercise ™ DBS Remote Control 3 Directions for Use From the Clinician Menu: Clear Link. The Clear Link to Stimulator? screen displays. 1. Select 2. Select Yes to clear the link to the Stimulator. Select No to cancel the action. Impedances You can use the Remote Control to check impedances.

  • Page 21: Reset Stimulator

    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.

  • Page 22: Exit Clinician Mode

    Vercise ™ DBS Remote Control 3 Directions for Use Yes to reset the Stimulator 4. Select 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 icon at the top right of the Home screen indicates the charge level of the Remote Control battery.

  • Page 23: End Of Programmed Service (For Non-Rechargeable Stimulators Only)

    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 defined 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.

  • Page 24: Eri (Elective Replacement Indicator) Screen (For Non-Rechargeable Stimulator Only)

    Vercise ™ DBS Remote Control 3 Directions for Use 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.

  • Page 25: Troubleshooting

    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.

  • Page 26: No Program To Run Screen

    Vercise ™ DBS Remote Control 3 Directions for Use 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.

  • Page 27: Unsupported Stimulator Screen

    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.

  • Page 28: Stimulator Error Screen

    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 Scientific to order a replacement Remote Control. Remote Error Press to continue...
  • Page 29 Troubleshooting Vercise™ DBS Remote Control 3 Directions for Use 92104389-01 25 of 27...
  • Page 30 Vercise ™ DBS Remote Control 3 Directions for Use Icon Description and Index Alert Volume 9 Change Program 5 Clear Link 14, 15, 16 Clinician Menu 13, 14, 15, 16, 17, 18 Home 2, 3, 4, 18 Languages 3, 10 Main Menu 3, 4, 5, 6, 7, 8, 18 Navigation 2, 3, 7, 14 Program 2, 4, 5, 6...
  • Page 31 Icon Description and Index Remote Battery 18 Remote Information 11, 12 Rescan 15 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...
  • Page 32 Legal Manufacturer Australian Sponsor EU Authorized Address Representative Boston Scientific Neuromodulation Boston Scientific (Australia) Pty Ltd Boston Scientific Limited Corporation PO Box 332 Ballybrit Business Park 25155 Rye Canyon Loop BOTANY Galway, Ireland Valencia, CA 91355 USA NSW 1455 T: +33 (0) 1 39 30 97 00...

This manual is also suitable for:

Db-5552-sDb-5552-1

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