Boston Scientific Freelink SC-5270 Manual

Directions for Use
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92395488-02
Content: MP92395488-02 REV A
Freelink™ Remote Control
Directions for Use
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Clinician Remote Control Directions for Use
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Guarantees
Boston Scientic Corporation reserves the right to modify, without prior notice, information relating to its
products in order to improve their reliability or operating capacity.
Drawings are for illustration purposes only.
Trademarks
The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and
any use of such marks by Boston Scientic Neuromodulation Corporation is under license.
WaveWriter Alpha™ and FreeLink™ are trademarks of Boston Scientic Corporation or its afliates.
All other trademarks are the property of their respective owners.
Additional Information
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 Scientic, refer to the Information for Prescribers DFU for
your system. For other device-specic information not included in this manual, labeling symbols, and
warranty information, refer to the appropriate DFU for your System as listed on your Reference Guide.
Thorough this document, the WaveWriter Alpha™ and WaveWriter Alpha 16 Systems will be referred to
as the WaveWriter Alpha System. WaveWriter Alpha™ Prime and WaveWriter Alpha Prime 16 Systems
will be referred to as the WaveWriter Alpha Prime Systems.
Product Model Numbers
Model Number Description
SC-5270 Freelink™ Remote Control
SC-6386 Pairing Magnet
SC-5572-1 SC-5572-1A Freelink Remote Control Kit
Note: Only the device models that are appropriate for your region will be provided.

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Table of Contents
Description...............................................................................................................................................1
Cautions ...........................................................................................................................................................1
Remote Control Features........................................................................................................................1
Basic Operation.......................................................................................................................................2
Unlocking the RC .............................................................................................................................................2
Turning Therapy On/Off ....................................................................................................................................2
Selecting Your Language/Screen Preference ..................................................................................................2
The Home Screen ............................................................................................................................................3
Adjusting Stimulation Amplitude from the Home Screen ..................................................................................4
The Main Menu.........................................................................................................................................4
Accessing the Main Menu ................................................................................................................................4
Program Selection and Activation ....................................................................................................................5
Selecting Stimulation Areas to Modify Programs..............................................................................................6
Saving Modied 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
Stimulator Search and Linking .......................................................................................................................24
Clear Link .......................................................................................................................................................26
Impedances ....................................................................................................................................................27
Reset Stimulator .............................................................................................................................................27
CP Mode: Stimulator ......................................................................................................................................28
Exit Clinician Mode .........................................................................................................................................28
MRI Mode................................................................................................................................................29
Enabling MRI Mode ........................................................................................................................................29
Disabling MRI Mode .......................................................................................................................................32
MRI Mode Error Screens ................................................................................................................................34
Charge Stimulator Now Screen (Rechargeable Stimulators Only) .................................................................35
Charge Stimulator Now or Disable MRI Mode Screen (Rechargeable Stimulators Only) ..............................36
Stimulator Battery Low Screen Due to ERI or EOS (Non-Rechargeable Stimulators Only) ...........................37
ERI or EOS During MRI Mode .......................................................................................................................38
Impedances Out Of Range Screen ................................................................................................................39
Stimulator Error Screen ..................................................................................................................................40
Recharging the RC ................................................................................................................................41

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Troubleshooting ....................................................................................................................................43
Bluetooth Help ................................................................................................................................................43
No Program to Run Screen ............................................................................................................................44
Invalid Program Screen ..................................................................................................................................44
Unsupported Stimulator Screen .....................................................................................................................45
System Settings Reset Screen .......................................................................................................................45
Stimulator Error Screen ..................................................................................................................................46
Remote Error Screen .....................................................................................................................................46
End of Programmed Service ................................................................................................................47
Non-rechargeable IPG Battery Status .................................................................................................48
Icon Description ....................................................................................................................................49

Description
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Description
The Freelink™ Remote Control (RC) is a handheld device that allows you to communicate with and
control the Stimulators.
Cautions
• Keep the RC dry. It should not be exposed to moisture.
• Do not connect the RC USB port to any other device except to the RC charger provided with it.
• Keep the RC away from pets, pests and children 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. Also acts as a shortcut (press and hold) to
prepare the Stimulator for connection to the CP.
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 Buttons and : allows
scrolling through a selected menu
10, 11. Navigation Buttons and : makes 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.

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Basic Operation
The RC communicates with the Stimulator through a Bluetooth® Low Energy telemetry link. The RC
has a typical communication range of up to 3 meters (9.8 ft) with the Boston Scientic WaveWriter
Alpha™ or WaveWriter Alpha Prime Implantable Pulse Generator, and a typical communication range
of up to 6 meters (19.7 ft) with the compatible Boston Scientic External Trial Stimulator.
As an operator of this device, perform only the following service and maintenance tasks on the device:
• Recharging, see “Recharging the RC” on page 41
• Cleaning
Ensure that this device 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 iconic screen or a text screen in one of the languages provided.
Refer to “Languages” on page 19 for additional instructions.
Note: Throughout this manual, the English text screen is shown paired with the corresponding iconic
screen.
Note: All features of the RC listed in this manual may not be available to you (for example, Schedules).
The settings displayed are dependent on the RC, Stimulator, and therapy congurations.

Basic Operation
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The Home Screen
The Remote Control (RC) Home screen displays information for the specic Stimulator and stimulation
therapy programmed. If a program is running, the Home Screen will display the following information:
• Name of the Program
• Number of the Program
• Stimulation Amplitude (Level) selected, as both a graph and a percentage of the maximum available
limit
Example: Home Screens for Stimulators 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 Schedule
• Name of the active Program within the Schedule
• Total Time that the active Program will run
• Time that elapsed for the active Program
Example: Home Screens for Stimulators with Active Schedules

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Adjusting Stimulation Amplitude from the Home Screen
1. Press the Home button on the left side of the RC to view the Home screen.
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.
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 congurations, some selection may be unavailable.
1. Press the button on the left side of the RC to display the Home screen:
2. From the Home screen, press the Right Arrow button to select the Main Menu.

The Main Menu
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Program Selection and Activation
The Programs Menu allows patients to change to another program, save modications to Programs,
restore programs to 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 Program.
4. Press the Right Arrow button to Select the Program.

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Selecting Stimulation Areas to Modify Programs
Each Program can include settings for up to four Stimulation Areas. Each Stimulation Area is identied
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.

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2. Press the Minus button to decrease the Amplitude (level) of stimulation.
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.

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Saving Modied Programs
If the stimulation amplitude, pulse width, or rate have been changed, the new settings can 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.

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Restoring Programs
Restoring Programs removes saved changes to a Program and 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 conrmation screen displays.
4. Select Yes to restore the Program to the Clinic Settings.
or
Select No to cancel the action.

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Copying Programs
You can copy an existing Program to a new Program.
1. Press the button on the left 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?
SelectBack
5. Select Yes to Overwrite the Program.
or
Select No to cancel the action.
The Copy to... conrmation screen displays.

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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.

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Managing Schedules
Schedules allows patients to select and change to a different schedule, exclude programs from a
schedule, or advance to the next program in a schedule.
Note: Depending on the stimulator congurations, 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 button or the Right Arrow button.

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2. Press the Up or Down Arrow buttons to navigate to the desired 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.

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5. If No is selected, the program 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.

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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:

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Entering a Therapy Rating
The Therapy Rating is a way for the patient to communicate real time preferences to different therapy
types. Their preferences are recorded on a ve star rating scale.
Note: Depending on stimulator congurations, 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 the Right Arrow button to make a selection.