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Boston Scientific DB-5250-S, Handbook

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Vercise™ DBS Remote Control 3 Handbook, 92104391-01

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Summary of Contents for DB-5250-S

Page 1: ...Vercise DBS Remote Control 3 Handbook 92104391 01 Content 92116334 REV C CAUTION Federal law restricts this device to sale distribution and use by or on the order of a physician ...

Page 2: ...ndbook 92104391 01 Product Model Numbers Model 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 NM 6310 USB Power Supply NM 6600 Patient Travel Case ...

Page 3: ...s manual for additional information on your Deep Brain Stimulation System such as indications for use contraindications warnings precautions adverse effects storage and handling device disposal and information for contacting Boston Scientific For charging instructions for rechargeable Stimulators refer to the Vercise DBS Charging Handbook Technical Support There are no user serviceable parts If yo...

Page 4: ... 4 Vercise DBS Remote Control 3 Handbook 92104391 01 Introduction 6 How To Use Programs 19 About System Settings 29 Reminders and Messages 35 Using the Remote Control 11 Troubleshooting 43 Table of Contents ...

Page 5: ...TRODUCTION Page 5 Vercise DBS Remote Control 3 Handbook 92104391 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 ...

Page 6: ...ant messages about your Stimulator and Remote Control battery status You should check your Remote Control at least once per month Press Side Butto to Unloc Stimulatio OFF Stimulatio Introduction 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 Remot...

Page 7: ...n and Programs button P On the front of the Remote Control you will find the Stimulation ON OFF button and the and buttons that allow you to adjust features such as the Remote Control volume and brightness Below the Stimulation ON OFF button are the Navigation buttons which allow you to navigate through various menus P Press Side Button to Unlock Stimulation OFF B 1 P Home Programs Lock Unlock Nav...

Page 8: ... preserve the Remote Control s battery The screen lights up when the Remote Control is unlocked and remains on while the Remote Control is being used To change the brightness of the screen see About System Settings Typically when the Remote Control is in use the Home screen displays CROP IN TIGHTER SO SCREEN IS MORE LEGIBLE CROP IN TIGHTER SO SCREEN IS MORE LEGIBLE CROP IN TIGHTER SO SCREEN IS MOR...

Page 9: ...current battery level of the Stimulator Icons at the top of the Home screen indicate the charge level of the Remote Control battery and the number of the Program currently running Note Pressing the Home button from almost all other screens will return you to the Home Screen Home Screen Program Number Stimulator Battery Level Non Rechargeable Stimulator Remote Control Battery Level Rechargeable Sti...

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Page 11: ...Quick Start Guide 12 Turn Stimulation ON OFF 14 Recharging the Remote Control 15 Accessories 16 Using the Remote Control ...

Page 12: ...Vercise DBS Remote Control 3 Handbook 92104391 01 Page 12 Release Side Button to Unlock 3 1 2 Quick Start Guide Unlock To turn Stimulation ON press To turn Stimulation OFF press ...

Page 13: ...Vercise DBS Remote Control 3 Handbook 92104391 01 QUICK START Page 13 To access the Main Menu press 4 5 Lock ...

Page 14: ...o turn stimulation ON or OFF you must unlock the Remote Control first then press the Stimulation ON OFF button Note Stimulation will not automatically turn OFF when the Remote Control is locked or when the screen darkens to preserve power in the Remote Control battery To START STOP stimulation press Turn Stimulation ON OFF Page 14 ...

Page 15: ...the battery when 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 Connect the power plug end of the USB Power Supply to a power outlet The Remote Control has a typical battery service life of 400 charging cycles Charging Remote ...

Page 16: ... while the device is in the Silicone Case The side buttons that are covered by the Silicone Case are still available for use Holster The Remote Control holster allows you to carry the Remote Control on a belt You can only access the Stimulation ON OFF button and the USB port of the Remote Control while it is enclosed in the holster Accessories CAUTION Always place the Remote Control in the Silicon...

Page 17: ...ry 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 Connect the power plug on the Power Supply to a power outlet The USB port on the Remote Control is designed to accept a standard 5V Mini B USB power supply ...

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Page 19: ...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 How To Use Programs ...

Page 20: ...ulation is delivered according to the configured settings The Remote Control can store up to four programs numbered 1 through 4 for you to select and activate at any time Each Program is identified by a number Each Program P may apply stimulation to as many as four stimulation areas For example one area may correspond to a right brain target while another area may correspond to a left brain target...

Page 21: ...ur stimulation level you may adjust stimulation level from the Main Menu Select Stimulation then select the amplitude that you wish to change Use the or button to adjust stimulation On the Amplitude screen L corresponds to the left side of the body and R corresponds to the right side of the body If you adjust stimulation to the limit of the allowable range the Limit Reached screen will appear Pres...

Page 22: ... the button can also be pressed to make a selection If your physician has configured Programs that can be changed there are two ways to view the Programs menu From the Main Menu select Programs P by pressing Press the Programs button P on the left side of the Remote Control Accessing Programs ...

Page 23: ...ion ON OFF and adjust stimulation level for the Program currently running Change the currently running Program to a different Program if available Restore a Program to the settings that your healthcare provider last configured for you If any changes were made to your stimulation for example changing stimulation strength the changes will save automatically Overview of the Programs Menu ...

Page 24: ... Vercise DBS Remote Control 3 Handbook 92104391 01 Change to a Different Program From the Home Screen press to display the Main Menu Press again to enter the Programs menu P Press again to enter the menu 2 3 1 ...

Page 25: ...PROGRAMS Page 25 Vercise DBS Remote Control 3 Handbook 92104391 01 Press to select the desired Program Press to activate the selected Program 4 5 ...

Page 26: ...you want to change the Program back to the way it was configured by your physician you can do so by restoring the Program Restore a Program From the Main Menu press to select Programs P Press to highlight Restore to Clinic Settings Press to select Restore to Clinic Settings 2 1 ...

Page 27: ...trol 3 Handbook 92104391 01 The Screen displays all Programs configured by your physician Navigate to the Program you wish to restore and press Select Yes to restore the program or No to cancel The Restore confirmation screen displays 5 4 3 ...

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Page 29: ...Adjust Screen Brightness 31 Adjust Volume 32 View Information about Your Remote Control or Stimulator 33 About System Settings ...

Page 30: ...mote 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 Your physician can access special functions through the Clinician Menu password protected to aid you in your therapy About System Settings ...

Page 31: ... Control 3 Handbook 92104391 01 1 3 From the Main Menu select System Settings Select Remote Settings by pressing Select Screen Brightness by pressing 2 4 To decrease or increase Screen Brightness press the or the button Adjust Screen Brightness ...

Page 32: ...em Settings Select Remote Settings by pressing Select Alert Volume by pressing To increase or decrease screen volume press the or the button The Remote Control emits a single short beep whenever you press a button The volume of the alert can be adjusted or turned off Adjust Volume 1 3 2 4 ...

Page 33: ...ings Select System Info by pressing Select Remote Info by pressing Select Stimulator Info by pressing You can view basic information about your Remote Control and Stimulator that may be helpful for your physician when troubleshooting an issue OR View Information about Your Remote Control or Stimulator 3a 3b 1 2 ...

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Page 35: ...37 Charging Remote Screen 38 Charger Disconnect Screen 38 Remote Battery Full Screen 39 Button Stuck 39 End of Programmed Service Non Recharageable Stimulators Only 40 ERI Screen Non Rechargeable Stimulators Only 41 End of Service EOS Screen Non Rechargeable Stimulators Only 42 Reminders and Messages ...

Page 36: ...geable Stimulators Only For a rechargeable Stimulator the Remote Control will provide on screen messages to remind you when your Stimulator battery is low One of the following messages will display For instructions on charging your Rechargeable Stimulator refer to the Vercise DBS Charging Handbook ...

Page 37: ...Remote Control Low Battery Message The Remote Control will provide on screen messages to remind you when your Remote Control battery is low The following messages will display Refer to Recharging the Remote Control section for more information on charging your Remote Control ...

Page 38: ...isplayed when the Remote Control is being used and the USB power supply is plugged in This screen is displayed when the Remote Control is being used and the USB power supply is disconnected Charging Remote Charger Disconnected Charging Remote Screen Charger Disconnect Screen ...

Page 39: ...ton is stuck on the Remote Control other button presses may not function as intended The Remote Control will provide the following on screen message if it detects a stuck button Refer to the instructions for cleaning the Remote Control in your Information for Patients Manual If the button is still stuck contact Boston Scientific Remote Battery Full Screen Button Stuck Remote Battery Full ...

Page 40: ...rammed period the Remote Control will display the following on screen message Press to clear the message The message will re appear 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 180 Remaining days of service Press to continue End of...

Page 41: ...depletion it will enter Elective Replacement Indicator ERI mode and will display the following message Stimulator near end of service Call your doctor Surgery is required to replace the implanted non rechargeable Stimulator Call your physician to report the ERI message screen Press to clear this information screen This screen will appear whenever the Remote Control is activated ...

Page 42: ...the Remote Control will display the following EOS message Stimulator at end of service Call your doctor Stimulation is not available Surgery is required to replace the implanted non rechargeable Stimulator The Home Screen will also display the EOS indicator icon End of Service EOS Screen Non Rechargeable Stimulators Only Page 42 ...

Page 43: ... 44 Unlinked Remote Control 47 No Program to Run Screen 48 Invalid Program Screen 48 Unsupported Stimulator Screen 49 System Settings Reset Screen 49 Stimulator Error Screen 50 Remote Error Screen 50 Troubleshooting ...

Page 44: ...omputer monitors These can affect wireless communication You will continue to have access to the Remote Control menus even if it 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 sen...

Page 45: ... Remote Control is unable to communicate with the Stimulator the Telemetry error message Communication Failed will appear To retry communication with the Stimulator select Retry This resends the last command To cancel communication and return to the System Settings screen press ...

Page 46: ...the Stimulator To use the Telemetry Help tool select Telemetry Help The following screen will be displayed 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 47: ... accidentally communicating with another Stimulator If your Remote Control is not linked to your Stimulator i e when you have a brand new Remote Control the following screen will appear and will prompt you to link the Remote Control to the Stimulator Please contact your physician if you see this message Your physician can access special functions through the Clinician Menu to link your Remote Cont...

Page 48: ...to continue No Program to Run P P Invalid Program P Press to continue No Program to Run Screen Invalid Program Screen This screen is displayed when the Stimulator has no Programs to run This screen is displayed when the Stimulator attempts to run an invalid Program ...

Page 49: ...ings Reset Screen This screen is displayed when the Remote Control detects an incompatible Stimulator This screen is displayed when the Remote Control experiences an error and a reset of the Remote Control is required Press to continue All Remote Control settings will be restored to the default factory settings Unsupported Stimulator Press to continue ...

Page 50: ...critical error Press to acknowledge the message and continue This screen is displayed when there is a critical error on the Remote Control which makes the Remote Control unusable Please contact Boston Scientific or your physician to order a replacement Remote Control Stimulator Error Press to continue Remote Error Press to continue ...

Page 51: ...Vercise DBS Remote Control 3 Handbook 92104391 01 A Alert Volume 30 32 C Change Program 23 24 Consult DFU 36 37 39 H Home 7 9 L Language Setting 30 M Main Menu 13 21 22 24 26 31 32 33 N Navigation 7 No 27 Index ...

Page 52: ...R Remote 30 31 32 Remote Battery 9 Remote Information 33 Restore to Clinic Settings 23 26 Retry 45 S Screen Brightness 30 31 Stimulation Level 21 Stimulation OFF 7 9 12 14 16 23 Stimulation ON 7 9 12 14 16 23 Stimulator 30 Stimulator Battery 9 Stimulator Information 33 System Info 33 ...

Page 53: ...Page 53 Vercise DBS Remote Control 3 Handbook 92104391 01 System Settings 30 31 32 33 Y Yes 27 ...

Page 54: ...ientific com AUS Australian Sponsor Address Boston Scientific Australia Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1800 676 133 Free Fax 1800 836 666 EU Authorized Representative Boston Scientific Limited Ballybrit Business Park Galway Ireland T 33 0 1 39 30 97 00 F 33 0 1 39 30 97 99 92104391 01 2018 07 2018 Boston Scientific Corporation or its affiliates All rights reserved ...

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