Boston Scientific Freelink SC-5552-1A Manual

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Freelink™ Remote Control
Directions for Use
Directions for Use
Mode d’emploi
Gebrauchsanweisung
Gebruiksaanwijzing

Clinician 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
All trademarks are the property of their respective holders.
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 spinal cord stimulator system. For other device-specic information not included in this manual,
labeling symbols, and warranty information, refer to the appropriate DFU for your SCS System as listed
on your Reference Guide.
Product Model Numbers
Model Number Description
SC-5250 Freelink™ Remote Control
SC-5552-1A Freelink™ Remote Control Kit

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Table of Contents
Description...............................................................................................................................................1
Cautions ...............................................................................................................................................1
Basic Operation.......................................................................................................................................1
Unlocking the RC .................................................................................................................................1
Turning Stimulation On/Off...................................................................................................................1
Selecting Your Language/Screen Preference ......................................................................................1
Adjusting Stimulation Amplitude on the Home Screen.........................................................................2
Program Selection and Activation ........................................................................................................3
RC Battery Status ................................................................................................................................4
Recharging the RC ..............................................................................................................................4
Remote Control Battery Service Life....................................................................................................4
Accessing Additional Options from the Main Menu.............................................................................6
Accessing the Main Menu ....................................................................................................................6
Selecting Stimulation Areas to Modify Programs .................................................................................6
Saving Modied Programs ...................................................................................................................9
Restoring Programs ...........................................................................................................................10
Copying Programs: ............................................................................................................................ 11
Deleting Programs .............................................................................................................................12
Accessing System Settings..................................................................................................................13
Remote Settings ................................................................................................................................13
System Info ........................................................................................................................................16
Accessing the Clinician Menu..............................................................................................................18
Impedances .......................................................................................................................................21
Reset Stimulator ................................................................................................................................22
Exit Clinician Mode ............................................................................................................................22
Lead Check (Precision Montage MRI Stimulator Only) .....................................................................22
Troubleshooting ....................................................................................................................................23
Telemetry Help ...................................................................................................................................23
No Program to Run Screen................................................................................................................24
Invalid Program Screen .....................................................................................................................24
Unsupported Stimulator Screen .........................................................................................................25
System Settings Reset Screen ..........................................................................................................25
Stimulator Error Screen .....................................................................................................................25
Remote Error Screen .........................................................................................................................26
End of Programmed Service ................................................................................................................26
Non-rechargeable IPG Battery Status .................................................................................................27
Icon Description and Index...................................................................................................................28

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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.
Basic Operation
The RC communicates with the Stimulator through a radio frequency (RF) telemetry link. The RC has
an effective communication range of up to 91.4 cm (36 inches) with the Boston Scientic rechargeable
Stimulator, and a nominal effective communication range of 55.9 cm (22 inches) with the Boston
Scientic non-rechargeable Stimulators.
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 Stimulation On/Off
Press the Stimulation 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 15 for additional instructions.
Note: Throughout this manual, the English text screen is shown paired with the corresponding iconic
screen.

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Adjusting Stimulation Amplitude on the Home Screen
The Home screen displays the number and name of the current Program, as well as information
about the stimulation amplitude (Level) currently selected. The stimulation amplitude is displayed as
both a graph and as a percentage of the maximum available limit.
1. Press the Home button on the left side of the RC to view the Home screen.
Home Screens with Rechargeable Stimulator
Home Screens with Non-rechargeable Stimulator
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.

Basic Operation
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Program Selection and Activation
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.
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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RC Battery Status
The icon at the top 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
Recharging the RC
Recharge the RC battery by connecting the RC to the USB-Power Supply provided with the RC.
Remote Control Battery Service Life
The RC battery has a typical service life of 400 charging cycles.

Basic Operation
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External Trial Stimulator or Rechargeable Stimulator Only
Note: 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.

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Accessing Additional Options from the Main Menu
The Main Menu gives you access to the following options:
• Programs - Allows you to change to another program, save programs after modications have
been made, restore programs to clinical settings, and delete programs.
• Stimulation Areas
• System Settings
Accessing the Main Menu
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.
Selecting Stimulation Areas to Modify Programs
Each Program can include settings for up to 4 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.

Accessing Additional Options from the Main Menu
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2. Select the desired area. The Area screen displays with the following parameters options:
3. Select the parameter that you would like to modify.
Amplitude
From the Area screen:
1. Select Amplitude.
2. Press the Minus button to decrease the Amplitude (level) of stimulation.
3. Press the Plus button to increase the Amplitude (level) of stimulation.

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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.

Accessing Additional Options from the Main Menu
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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 Programs.
2. Select Save. The Save ? screen displays.
3. Select Yes to save.
or
Select No to discard.

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Restoring Programs
If after saving changes to a Program, you decide that you want to revert the Program back its Clinic
Settings, you can do so by restoring the Program.
1. Press the button on the left side of the RC.
or
From the Main Menu screen, select 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.

Accessing Additional Options from the Main Menu
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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 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.
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 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.

Accessing System Settings
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Accessing System Settings
From the Main Menu:
1. Select System Settings. 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.

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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.
2. Press the Minus button to decrease the brightness
3. Press the Plus button to increase the brightness.

Accessing System Settings
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Languages
The RC allows you to congure 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 conrmation screen displays to conrm your selection.

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System Info
The System Info menu gives you the option of viewing information regarding the RC or the Stimulator.
From the System Settings menu:
1. Select System Info.
Remote Info
1. Select Remote Info to view the Remote Info screen.
The Remote Info screen displays the following information:
• Serial Number
• Model Number
• Boot Version
• Firmware Version