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Boston Scientific DB-5552-1, Directions For Use Manual

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Vercise

™

 DBS Remote Control 3 Directions for Use

Vercise™ DBS Remote Control 3 Directions for Use 

92104389-01    26 of 27

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

Summary of Contents for DB-5552-1

Page 1: ...92104389 01 Content 92116332 REV B 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 ...

Page 2: ...zation component disposal and storage and handling refer to the Information for Prescribers DFU For other device specific 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 specific question or issue please contact your sales representative or call 833 DBS...

Page 3: ...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...

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

Page 5: ...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 K...

Page 6: ...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 non rechargeable VerciseTM PC Stimulator and an average communication range of 36 inches 91 4cm with the rechargeable Vercise GeviaTM Stimulator When using the...

Page 7: ...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 ...

Page 8: ...ll 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...

Page 9: ... 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...

Page 10: ...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 Confirmation screen displays 3 Select Yes to restore the program to the clinic settings or Select...

Page 11: ...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 ...

Page 12: ... 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 ...

Page 13: ... Use 92104389 01 9 of 27 Alert Volume From the Remote Settings menu 1 Select Alert Volume 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 ...

Page 14: ...the Plus button to increase the brightness Languages The Remote Control allows you to configure 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 Confirmation screen displays to confirm your selection ...

Page 15: ...s for Use 92104389 01 11 of 27 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 ...

Page 16: ...umber 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 ...

Page 17: ...ersion 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 Scientific representative for the Clinician Password From the System Settings menu 1 Select the Clinician Menu The Password screen displays _ _ _ _ Enter Cancel A ...

Page 18: ...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 Sti...

Page 19: ...timulator 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 ...

Page 20: ...an 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 ...

Page 21: ...ce 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 ...

Page 22: ... 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 b...

Page 23: ...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 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 reac...

Page 24: ...e 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 Thi...

Page 25: ...e 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 Help Communication Failed Select Cancel Retry Telemetry Error To retry communication with the Stimulator this r...

Page 26: ...nce 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 Press to continue No Program to Run P 0 P Invalid Program Screen This screen is displayed when the Stimulator attempts to run an invalid program ...

Page 27: ...ulator 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 Press to continue System Settings Reset ...

Page 28: ...or 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 Scientific 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 ...

Page 29: ...Troubleshooting Vercise DBS Remote Control 3 Directions for Use 92104389 01 25 of 27 ...

Page 30: ...e Control 3 Directions for Use 92104389 01 26 of 27 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 ...

Page 31: ... 27 of 27 R Remote Battery 18 Remote Information 11 12 Rescan 15 Restore to Clinic Settings 6 Retry 21 S 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: ...789 5899 in US and Canada 661 949 4000 661 949 4022 Fax 866 789 6364 TTY www bostonscientific com Email neuro info bsci 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...

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