Boston Scientific Vercise DBS 4 Handbook
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Boston Scientific Vercise DBS 4 Handbook

Boston Scientific Vercise DBS 4 Handbook

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CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician.
Vercise™ DBS
Remote Control 4
Handbook
92441284-01
Content: MP92441284-01 REV A
92441284-01

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  • Page 1 Vercise™ DBS Remote Control 4 Handbook 92441284-01 Content: MP92441284-01 REV A CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician. 92441284-01...
  • Page 2 Trademarks All trademarks are the property of their respective holders. The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Boston Scientific Neuromodulation Corporation is under license. 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.
  • Page 3 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Additional Information Refer to the Information for Patients manual for additional information on your Deep Brain Stimulation System, such as indications for use, contraindications, warnings, precautions, adverse effects, storage and handling, and device disposal. For charging instructions for rechargeable Stimulators, refer to the Vercise DBS Charging Handbook .

  • Page 4: Table Of Contents

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Table of Contents Introduction Using the Remote Control How To Use Programs About System Settings About MRI Mode Reminders and Messages Troubleshooting Page 4...
  • Page 5 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 This manual has been color‑coded to help you use the Remote Control while referencing the manual. Each section is labeled and color‑coded INTRODUCTION Page 5...

  • Page 6: Introduction

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Introduction CAUTIONS The Remote Control is a hand‑held device that allows you to communicate with your • Keep the Remote Control Stimulator. Typically, you will be using the dry. It should not be Press Remote Control to turn stimulation ON or OFF.
  • Page 7 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Remote Control Buttons Buttons are located on the front and sides of the Remote Control as shown in the picture. Lock / Home Unlock On the right side of the Remote Control, Press Side Button you will find the Lock/Unlock button to Unlock...
  • Page 8 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Remote Control Screen The Remote Control screen displays menus, icons, status messages, error messages, and other information. When the Remote Control is not in use (for example, the buttons are not being pressed), the screen automatically darkens after approximately 1 minute to preserve the Remote Control’s battery.
  • Page 9 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Home Screen Note The Home screen indicates whether stimulation is ON . If you have a rechargeable Stimulator, the Home Screen Pressing the Home button will also display the current battery level of the Stimulator. from almost all other screens will return you to Icons at the top of the Home screen indicate the charge level...
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  • Page 11: Using The Remote Control

    Using the Remote Control Quick Start Guide ............12 Turn Stimulation ON/OFF ..........14 Recharging the Remote Control ........15 Accessories ..............16...

  • Page 12: Quick Start Guide

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Quick Start Guide Release Side Button to Unlock To turn Stimulation ON To turn Stimulation OFF Unlock press press Page 12...
  • Page 13 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 To access the Lock Main Menu press QUICK START Page 13...

  • Page 14: Turn Stimulation On/Off

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Turn Stimulation ON/OFF Note Stimulation can be turned ON and OFF by pressing the Stimulation ON/OFF button . To turn stimulation ON or OFF, you must unlock Stimulation will not the Remote Control first; then, press the Stimulation ON/OFF button. automatically turn OFF when the Remote Control is locked...

  • Page 15: Recharging The Remote Control

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Recharging the Remote Control The Remote Control displays messages Recharge the Remote Control battery reminding you to recharge the battery when by connecting the Remote Control the battery power is low. to the USB Power Supply provided. Connect the power plug end of the USB Power Supply to a power outlet.

  • Page 16: Accessories

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Accessories CAUTION The following accessories are provided with the Remote Control: Always place the Silicone Case ‑ The Silicone Case Holster ‑ The Remote Control Remote Control in allows you to customize your holster allows you to carry the the Silicone Case so Remote Control.
  • Page 17 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 USB Power Supply ‑ The USB Power Supply is used to recharge the Remote Control battery. Connect the USB connector on the Power Supply to the Remote Control. Then, find a convenient electrical outlet that will not expose the Remote Control or Power Supply parts to water or direct heat.
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  • Page 19: How To Use Programs

    How To Use Programs What Is a Program? ............20 Changing Stimulation Level ...........21 Accessing Programs ............22 Overview of the Programs Menu ........23 Change to a Different Program ........24 Restore a Program ............26...

  • Page 20: What Is A Program

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 What Is a Program? A Stimulation Program is a group of configured settings that produce the stimulation to help you manage your symptoms. One or more Programs were configured by your physician. Whenever you are using your Stimulator, one of these Programs is active, and stimulation is delivered according to the configured settings.

  • Page 21: Changing Stimulation Level

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Changing Stimulation Level Use the button to adjust stimulation. Physicians may allow certain patients to On the Amplitude screen, L corresponds to the change the stimulation level of individual left side of the body and R corresponds to the areas of a Program.

  • Page 22: Accessing Programs

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Accessing Programs If your physician has configured Programs that can be changed, there Note are two ways to view the Programs menu: After entering the Main Menu Press the button can Programs also be pressed to button make a selection.

  • Page 23: Overview Of The Programs Menu

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Overview of the Programs Menu If your physician has configured Programs that can be changed, you can do any of the following operations: • Turn Stimulation ON/OFF and adjust stimulation level for the Program currently running •...

  • Page 24: Change To A Different Program

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Change to a Different Program From the Home Screen, Press again to enter Press again to enter press to display the the Programs menu the menu Main Menu Page 24...
  • Page 25 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Press to select Press to activate the the desired Program. selected Program. PROGRAMS Page 25...

  • Page 26: Restore A Program

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Restore a Program If you decide that you want to change the Program back to the way it was configured by your physician, you can do so by restoring the Program. From the Main Menu Press to highlight Restore to Clinic , press...
  • Page 27 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 The Screen displays all Programs Select Yes to restore The Restore confirmation configured by your physician. the Program or No screen displays. Navigate to the Program you cancel. wish to restore and press PROGRAMS Page 27...
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  • Page 29: About System Settings

    About System Settings About System Settings ..............30 Adjust Screen Brightness ............. 31 Adjust Volume ................32 View Information about Your Remote Control or Stimulator ..33...

  • Page 30: About System Settings

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 About System Settings Using the System Settings , you can set or change a Remote Control interface settings, like Alert Volume Screen Brightness , and the Language setting In addition, you can view information about the Remote Control and the Stimulator .

  • Page 31: Adjust Screen Brightness

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Adjust Screen Brightness From the Main Menu Select Remote Select Screen To decrease or increase , select System Settings Brightness Screen Brightness, Settings pressing by pressing press the or the button. SYSTEM SETTINGS Page 31...

  • Page 32: Adjust Volume

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Adjust Volume The Remote Control emits a single, short “beep” whenever you press a button. The volume of the alert can be adjusted or turned off. From the Main Menu Select Remote Select Alert To increase or decrease , select System Settings...

  • Page 33: View Information About Your Remote Control Or Stimulator

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 View Information about Your Remote Control or Stimulator You can view basic information about your Remote Control and Stimulator that may be helpful for your physician when troubleshooting an issue. From the Main Menu Select System Info Select Remote Info Select Stimulator Info...

  • Page 34: About Mri Mode

    About MRI Mode About MRI Mode ................... 35 Enabling MRI Mode ................36 Disabling MRI Mode ................38 MRI Mode Error Messages (Rechargeable Stimulators Only) ....40 MRI Mode Error Messages (Non‑Rechargeable Stimulators Only) .... 42 MRI Mode Error Messages ..............44...

  • Page 35: About Mri Mode

    Guidelines for Boston Scientific DBS Systems are followed before an MRI scan is performed. Ask your physician or MRI center to either contact Boston Scientific Customer Support or go to www.bostonscientific.com/manuals for the latest version of the ImageReady MRI guidelines manual.

  • Page 36: Enabling Mri Mode

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Enabling MRI Mode Select Yes to enter From the Home From the Main Press to navigate MRI mode or No to Screen, select Menu, select System to the Enter MRI cancel the action. display the Main Settings Mode...
  • Page 37 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 CAUTION The Remote Control is MR Unsafe and must not be taken into the MRI Scanner Room. Note Stimulation is automatically turned OFF when MRI Mode is enabled. The Stimulator The MRI Mode Enabled The Home Screen will display the MR performs a series of confirmation screen...

  • Page 38: Disabling Mri Mode

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Disabling MRI Mode Upon completion of the MRI scan, the Remote Control is used to disable MRI Mode. Main Menu Programs Stimulation Areas System Settings Back Select Select Yes to exit From the Home From the Main Press to navigate...
  • Page 39 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Note The Stimulator retains the settings that were set before enabling MRI Mode. If stimulation was ON before MRI Mode was enabled, then disabling MRI Mode turns stimulation back ON. If stimulation was OFF before MRI Mode was enabled, then disabling MRI Mode keeps stimulation OFF.

  • Page 40: Mri Mode Error Messages (Rechargeable Stimulators Only)

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 MRI Mode Error Messages (Rechargeable Stimulators Only) CAUTION Charge Stimulator Now Screen (Rechargeable Stimulators Only) The Charger is MR Unsafe and must The Stimulator battery not be taken into the must be fully charged MRI Scanner Room.
  • Page 41 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Charge Stimulator Now or Disable MRI Mode Screen (Rechargeable Stimulators Only) Disable the MRI Mode before charging A Charge Stimulator Now error message your Stimulator also appears when MRI Mode is enabled and Press to disable MRI Mode.

  • Page 42: Mri Mode Error Messages (Non-Rechargeable Stimulators Only)

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 MRI Mode Error Messages (Non‑Rechargeable Stimulators Only) Stimulator Battery Low (Non‑Rechargeable Stimulators Only) A Stimulator that has entered the Elective Replacement Indicator (ERI) or End of Service (EOS) period cannot be placed into MRI Mode. MRI Mode will not be enabled and the Remote Control will display “Cannot enter MRI Mode”...
  • Page 43 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 ERI or EOS During MRI Mode (Non‑Rechargeable Stimulators Only) If MRI Mode has already been enabled and the Stimulator battery power falls below the threshold value, the Remote Control will display a message that the Stimulator has entered the Elective Replacement Indicator (ERI) period or has reached End of Service (EOS) of the device.

  • Page 44: Mri Mode Error Messages

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 MRI Mode Error Messages Impedances out of Range Screen On enabling MRI Mode, the system performs a check of Lead impedances. If the impedances are not within the acceptable range, the Remote Control will display an error message.
  • Page 45 Your healthcare provider must check the integrity of the Enabling MRI Mode or Leads and review the risks listed in the physician manual to cancel the action. ImageReady MRI Guidelines for Boston Scientific DBS Systems before proceeding with an MRI scan. MRI Mode Page 45...
  • Page 46 Remote Control will display the Stimulator should not perform an MRI scan. Contact Error Screen. This screen may also be displayed when there is a communication the physician managing your DBS System or error between the Remote Control and Boston Scientific. Stimulator. Page 46...

  • Page 47: Reminders And Messages

    Reminders and Messages Stimulator Low Battery Messages (Rechargeable Stimulators Only) ......48 Remote Control Low Battery Message ................ 49 Charging Remote Screen ................... 50 Charger Disconnect Screen ..................50 Remote Battery Full Screen ..................51 Button Stuck ......................51 ERI Screen (Non‑Rechargeable Stimulators Only) ............52 End of Service (EOS) Screen (Non‑Rechargeable Stimulators Only) ......

  • Page 48: Stimulator Low Battery Messages (Rechargeable Stimulators Only)

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Stimulator Low Battery Messages (Rechargeable Stimulators Only) For a rechargeable Stimulator, the Remote For instructions on charging your Control will provide on‑screen messages to Rechargeable Stimulator, refer to the Vercise remind you when your Stimulator battery DBS Charging Handbook .

  • Page 49: Remote Control Low Battery Message

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Remote Control Low Battery Message The Remote Control will provide on‑screen Refer to “Recharging the Remote Control” messages to remind you when your Remote section of this manual for more information Control battery is low. The following on charging your Remote Control.

  • Page 50: Charging Remote Screen

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Charging Remote Screen Charger Disconnect Screen This screen is displayed when the Remote This screen is displayed when the Remote Control is being used and the USB power Control is being used and the USB power supply is plugged in.

  • Page 51: Remote Battery Full Screen

    Remote Battery Full Refer to the instructions for cleaning the Remote Control in your Information for Patients Manual . If the button is still stuck, contact Boston Scientific. REMIND/MESSAGE Page 51...

  • Page 52: Eri Screen (Non-Rechargeable Stimulators Only)

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 ERI Screen (Non‑Rechargeable Stimulators Only) When the battery of a non‑rechargeable Call your physician to report the ERI message Stimulator is nearing depletion, it will enter screen. Your Stimulator will still provide the Elective Replacement Indicator (ERI) mode programmed stimulation until the battery reaches End of Service (see the “End of...

  • Page 53: End Of Service (Eos) Screen (Non-Rechargeable Stimulators Only)

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 End of Service (EOS) Screen (Non‑Rechargeable Stimulators Only) When the battery of an implanted Surgery is required to replace the implanted non‑rechargeable stimulator is fully depleted, non‑rechargeable Stimulator. Call your the Remote Control will display the following physician to report the EOS message screen.
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  • Page 55: Troubleshooting

    Troubleshooting Bluetooth Help ..............56 Unlinked Remote Control ..........59 No Program to Run Screen ..........60 Invalid Program Screen ..........60 Unsupported Stimulator Screen ........61 System Settings Reset Screen ........61 Stimulator Error Screen ..........62 Remote Error Screen .............62 Icon Description ............63...

  • Page 56: Bluetooth Help

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Bluetooth Help The Remote Control has a range of If you enter a command to change 9.8 ft (3 m) with implanted Vercise Genus your settings or Programs while the Stimulators under normal conditions. Remote Control is outside of its effective communication range, you will have several When using the Remote Control, avoid...
  • Page 57 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 If the Remote Control is unable to To retry communication with the Stimulator, communicate with the Stimulator, the Remote select Retry . This resends the last Control will display the following Bluetooth command. To cancel communication and Error message: return to the System Settings screen, press ”Communication Failed”...
  • Page 58 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Bluetooth Help The Bluetooth Help tool is also available The telemetry bars indicate the strength of to assist you in improving communication wireless communication. The number of bars between the Remote Control and the will change depending on the distance and Stimulator.

  • Page 59: Unlinked Remote Control

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Unlinked Remote Control The Remote Control and Stimulator must Please contact your physician if you see this establish a one‑to‑one link in order to message. Your physician can access special communicate. This prevents a Remote Control functions through the Clinician Menu to link from accidentally communicating with your Remote Control to your Stimulator.

  • Page 60: No Program To Run Screen

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 No Program to Run Screen Invalid Program Screen This screen is displayed when the Stimulator This screen is displayed when the Stimulator has no Programs to run. attempts to run an invalid Program. No Program Invalid to Run...

  • Page 61: Unsupported Stimulator Screen

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Unsupported Stimulator Screen System Settings Reset Screen This screen is displayed when the Remote This screen is displayed when the Remote Control detects an incompatible Stimulator. Control experiences an error and a reset of the Remote Control is required.

  • Page 62: Stimulator Error Screen

    Remote Control unusable. Please contact Remote Control and Stimulator. Press Boston Scientific or your physician to order a acknowledge the message and continue. If replacement Remote Control. desired, retry the action that was interrupted by the error.

  • Page 63: Icon Description

    Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Icon Description Alert Volume Follow Instructions for Use Bluetooth Help Home Change Program Language Setting Lock/Unlock Enter MRI Mode Exit MRI Mode Main Menu Page 63...
  • Page 64 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Icon Description Minus Button MR Conditional Symbol Remote Remote Battery Navigation Remote Information Remote Settings Restore to Clinic Settings Program Retry Plus Button Page 64...
  • Page 65 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 Stimulator Information Screen Brightness System Information Stimulation Button System Settings Stimulation Level Stimulation OFF Stimulation ON Stimulator Stimulator Battery Page 65...
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  • Page 67 Vercise™ DBS Remote Control 4 Handbook, 92441284-01 This page intentionally left blank. TROUBLESHOOT Page 67 Page 67...
  • Page 68 Legal Australian Sponsor EU Authorized Manufacturer Address Representative Boston Scientific Neuromodulation Corporation Boston Scientific (Australia) Pty Ltd Boston Scientific Limited 25155 Rye Canyon Loop PO Box 332 Ballybrit Business Park Valencia, CA 91355 USA BOTANY Galway, Ireland (866) 789-5899 in US and Canada...

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