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Clinician Remote Control Directions for Use

Clinician Remote Control Directions for Use 

91171771-02      31 of 35

Unsupported Stimulator Screen

This screen is displayed when the RC detects an incompatible Stimulator.

Unsupported

Stimulator

?

Press      to continue

?

P

ress 

 

to 

continue.

System Settings Reset Screen

This screen is displayed when the RC experiences an error and a reset of the RC is required. Press 

 to continue. All RC settings will be restored to the default factory settings.

Press      to continue

System Settings

Reset

P

ress 

 

to 

continue.

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

P

ress 

 

to 

continue.

Содержание Freelink

Страница 1: ...91171771 02 Content ID 92089552 REV A Freelink Remote Control Directions for Use CAUTION Federal law restricts this device to sale distribution and use by or on the order of a physician ...

Страница 2: ...ion For Indications and related information see the Indications DFU For contraindications warnings precautions adverse events summary physician instructions storage and handling component disposal and contact information for Boston Scientific refer to the Information for Prescribers DFU for your spinal cord stimulator system For other device specific information not included in this manual labelin...

Страница 3: ...ied Programs 8 Restoring Programs 9 Copying Programs 10 Deleting Programs 11 Managing Schedules 12 Entering a Therapy Rating 16 Accessing System Settings 17 Remote Settings 17 System Info 20 Accessing the Clinician Menu 22 Impedances 25 Reset Stimulator 25 Exit Clinician Mode 25 Lead Check Precision Montage MRI Stimulator Only 26 Recharging the RC 27 Troubleshooting 29 Telemetry Help 29 No Program...

Страница 4: ...ren to avoid damage to the device 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 Therapy Button Turns Therapy ON or OFF 6 Minus Button Decreases selected parameter 7 Plus Button Increases selected parameter 8 9 Navigation Butt...

Страница 5: ...e is not in use while performing service and maintenance tasks Unlocking the RC The RC 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 RC Turning Therapy On Off Press the Therapy ON OFF button at any time to turn the Stimulator on or off Selecting Your Language Screen Preference The RC allows you to choose either an ico...

Страница 6: ...tors with Active Program Note When the RC connects to a non rechargeable Stimulator the RC will not display the Stimulator battery icon in the upper right corner of the Home screen If a Schedule is running the Home Screen will display the following information about the Schedule and the Programs within the Schedule Number of the Schedule Name of the Schedule Number of the active Program within the...

Страница 7: ...corner of the home screen 2 Press the Minus button to decrease the level of stimulation 3 Press the Plus button to increase the level of stimulation The Main Menu The Main Menu provides access to the following options P Programs Schedules Therapy Rating Stimulation Areas System Settings Accessing the Main Menu Note Depending on stimulator configurations some selection may be unavailable 1 Press th...

Страница 8: ...clinic settings and delete programs 1 Press the button on the left side of the RC to display the Programs screen Note You can also navigate to the Programs menu from the Main Menu Refer to Accessing the Main Menu for additional instructions 2 Select Change Program by pressing the Selection button or pressing the Right Arrow button 3 Press the Up or Down Arrow buttons to navigate to the desired Pro...

Страница 9: ...ach Stimulation Area is identified by a letter and a name These Stimulation Areas control Amplitude Pulse Width and Rate From the Main Menu 1 Select Stimulation Areas The Stimulation Areas screen displays Select the desired area The Area screen displays with the following parameters options 2 Select the parameter that you would like to modify Amplitude From the Area screen 1 Select Amplitude ...

Страница 10: ...timulation 3 Press the Plus button to increase the Amplitude level of stimulation Pulse Width From the Area screen 1 Select Pulse Width 2 Press the Minus button to decrease the Pulse Width 3 Press the Plus button to increase the Pulse Width Rate From the Area screen 1 Select Rate 2 Press the Minus button to decrease the Rate 3 Press the Plus button to increase the Rate ...

Страница 11: ...n be saved as the default stimulation for that Program The new settings will remain until a new change is saved or the Program is restored to its Clinic Settings Refer to Restoring Programs for additional information 1 Press the button the left side of the RC or From the Main Menu screen select P Programs 2 Select Save The Save screen displays 3 Select Yes to save or Select No to discard ...

Страница 12: ...d resets the Program to the original Clinic Settings 1 Press the button on the left side of the RC or From the Main Menu screen select P Programs 2 Select Restore to Clinic Settings The Restore screen displays 3 Select the Program you want to restore The Restore confirmation screen displays 4 Select Yes to restore the Program to the Clinic Settings or Select No to cancel the action ...

Страница 13: ... side of the RC or From the Main Menu screen select P Programs 2 Select Copy to 3 Select the Program that you want to copy the current Program to 4 The Overwrite screen displays if you are not copying to an empty slot Copy to 3 Program3 Yes No Overwrite Select Back 5 Select Yes to Overwrite the Program or Select No to cancel the action The Copy to confirmation screen displays ...

Страница 14: ...rections for Use 91171771 02 11 of 35 Deleting Programs 1 Press the button on the left side of the RC or From the Main Menu screen select P Programs 2 Select Delete 3 Select the Program to delete 4 Select Yes to Delete the selected program or Select No to cancel the action ...

Страница 15: ...m in a schedule Note Depending on the stimulator configurations some selections may be unavailable From the Main Menu 1 Press the Down Arrow to navigate to Schedules 2 Once Schedules is highlighted press the Selection button or the Right Arrow to access the Schedules Menu screen Selecting or Changing to a Different Schedule From the Schedules Menu 1 Select Change Schedule by pressing the Selection...

Страница 16: ...red Schedule 3 Press the Right Arrow button to Select the Schedule Exclude Program from a Schedule From the Schedules Main Menu 1 Press the Down Arrow button to navigate to Exclude Program 2 Select Exclude Program by pressing the Right Arrow 3 Press the Up or Down Arrow buttons to select Yes or No at the prompt 4 If Yes is selected the Program Excluded screen displays ...

Страница 17: ...am will not be excluded and you will be redirected to the Schedules Menu Advance Program within a Schedule From the Schedules Menu 1 Press the Down Arrow button to navigate to Next Program 2 Select Next Program by pressing the Right Arrow 3 Press the Up or Down Arrow buttons to select Yes or No at the prompt ...

Страница 18: ...ns for Use Clinician Remote Control Directions for Use 91171771 02 15 of 35 4 If Yes is selected the Program Advanced screen displays 5 If No is selected the program will not be advanced and you will be redirected to the Schedules Menu ...

Страница 19: ...d on a five star rating scale Note Depending on stimulator configurations some selections may be unavailable From the Main Menu 1 Press the Down Arrow to navigate to Therapy Rating 2 Once Therapy Rating is highlighted press the Selection button or the Right Arrow to access the Therapy Rating screen 3 Press the Up or Down Arrow buttons to navigate to the rating of the therapy at that moment 4 Press...

Страница 20: ... The System Settings screen displays When using the Precision Montage MRI Stimulator the Lead Check icon will also appear on the System Settings screen Remote Settings The Remote Settings option allows you to adjust the Alert Volume Screen Brightness and to select your language preference From the System Settings menu 1 Select Remote Settings to display the Remote Settings menu ...

Страница 21: ...ngs 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 2 Press the Minus button to decrease the brightness 3 Press the Plus button to increase the brightness ...

Страница 22: ...ges The RC allows you to configure your system to display one the following Text screen in one of the languages provided 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 ...

Страница 23: ...ewing information regarding the RC or the Stimulator From the System Settings menu 1 Select System Info Remote Info 2 Select Remote Info to view the Remote Info screen Serial Number Model Number Boot Version Firmware Version The Remote Info screen displays the following information Serial Number Model Number Boot Version Firmware Version ...

Страница 24: ...l information LCD Boot Version LCD Firmware Stimulator Info 1 Select Stimulator Info to view the Stimulator Info screen Serial Number Model Number Boot Version Firmware Version The Stimulator Info screen displays the following information Serial Number Model Number Boot Version Firmware Version Note The Model number and Serial number for the Trial Stimulator can be found by removing the battery co...

Страница 25: ...Pulse Width Rate To enter the Clinician Menu you must enter a password From the System Settings menu 1 Select the Clinician Menu The Password screen displays _ _ _ _ Enter Cancel A B C D E F G H I 0 1 2 3 4 5 6 7 8 9 S T U V W X Y Z J K L M N O P Q R 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 ...

Страница 26: ...u to search for a Stimulator and link to it From the Clinician Menu 1 Select Stimulator Search The Stimulator Search screen displays 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 ...

Страница 27: ...02 24 of 35 Clear Link If the RC is linked to a Stimulator the Clear Link option displays on the Clinician Menu 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 ...

Страница 28: ...0 A7 1000 A8 1450 B1 1000 B2 1450 B3 1000 B4 1450 B5 1450 B6 900 B7 8000 B8 2 Select Measure to check impedances 3 Select Back to go back to the Clinician Menu Reset Stimulator You can use the RC to reset the Stimulator From the Clinician Menu 1 Select Reset Stimulator The Reset Stimulator screen displays 2 Select Yes to reset the Stimulator or Select No to cancel the action Exit Clinician Mode Fr...

Страница 29: ...te Control Directions for Use 91171771 02 26 of 35 Lead Check Precision Montage MRI Stimulator Only For the Precision Montage MRI Stimulator you can use the Remote Control to test lead integrity From the Systems Settings menu 1 Select Lead Check ...

Страница 30: ...left of the Home screen indicates the charge level of the RC battery The RC will display messages reminding you to recharge the RC or the Stimulator if the battery power is low Charge Remote Now Recharge the RC battery by connecting the RC to the USB Power Supply provided with the RC The RC battery has a typical service life of 400 charging cycles ...

Страница 31: ...ote The following is not applicable to the Precision Novi Stimulator The icon at the top right of the Home screen indicates the charge level of the Stimulator battery The RC will display messages reminding you to recharge the Stimulator if the battery power is low Charge Stimulator Now Press to continue Charge Stimulator Now Press to continue ...

Страница 32: ...ings or programs while the remote control is outside of its effective communication range you will have several seconds to move the RC 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 RC is unable to communicate with the Stimulator the Telemetry Error ...

Страница 33: ...the strength of communication for 30 seconds or until is pressed Test the Remote at Different Positions Press to Exit Test the Remote at Different Positions Press to continue 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 Press to continue Invalid Program Screen This screen is displayed when the Stimulator atte...

Страница 34: ...ontinue System Settings Reset Screen This screen is displayed when the RC experiences an error and a reset of the RC is required Press to continue All RC settings will be restored to the default factory settings Press to continue System Settings Reset Press to continue Stimulator Error Screen This screen is displayed when there is a non critical Stimulator error Press to acknowledge the message an...

Страница 35: ... to continue Press to continue End of Programmed Service The Stimulator software has been programmed to end service after a defined period When the Stimulator is within approximately 180 days of the end of its programmed period the RC will display the following on screen message Press to continue Press to clear the message The message will reappear approximately weekly until the end of the Stimula...

Страница 36: ...anges made to the stimulation will not be saved and stimulation will not be available soon Advise the patient to contact their healthcare provider to report this message Press the select key to clear this information screen This screen will appear whenever the RC is activated End of Battery Life Screen The implanted non rechargeable Stimulator has reached its end of service Stimulation is not avai...

Страница 37: ... C Change Program 5 Change Schedule 12 Clinician Menu 22 24 25 Copy to 10 D Delete Program 11 E Exclude Program 13 H Home 4 27 L Languages 2 19 Lead Check 17 26 M Main Menu 22 N Navigation 1 22 No 8 9 10 11 23 24 25 P P Program 4 8 9 10 11 Pulse Width 6 7 22 R Rate 6 7 Remote 17 18 19 32 Remote Battery 27 Remote Information 20 Restore to Clinic Settings 9 Retry 29 ...

Страница 38: ...1171771 02 35 of 35 S Save Program 8 Schedules 3 4 12 Screen Brightness 17 18 Stimulation Area 6 Stimulator 2 23 25 27 28 31 Stimulator Battery 4 28 Stimulator Information 21 System Info 20 System Settings 4 17 22 31 T Therapy OFF 2 Therapy ON 2 Therapy Rating 4 16 Y Yes 8 9 10 11 23 24 25 ...

Страница 39: ...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 Authorised 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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