Boston Scientific Precidion Spectra RC Manual

.
Precision Spectra™
Clinician Remote Control
Directions for Use
SC-5532-1 Remote Control Kit
90668559-12 REV A
CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician.
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Clinician Remote Control Directions for Use
Clinician Remote Control Directions for Use
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Copyright
© 2015 Boston Scientic Corporation or its afliates. All Rights Reserved. These documents are the
property of Boston Scientic Corporation and shall not be reproduced, distributed, disclosed, or used
for manufacture or sale of device without the express written consent of Boston Scientic Corporation.
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
Precision Spectra is a trademark of Boston Scientic. Other brands and their products are trademarks
or registered trademarks of their respective holders and should be noted as such.

Table of Contents
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Table of Contents
Description................................................................................................................4
Basic Operation........................................................................................................4
Unlocking the RC............................................................................................................................... 4
Turning Stimulation On/Off................................................................................................................. 4
Selecting Your Language/Screen Preference.................................................................................... 4
Adjusting Stimulation Amplitude on the Home Screen....................................................................... 4
Program Selection and Activation...................................................................................................... 5
Stimulator and RC Battery Status...................................................................................................... 6
Recharging the RC ............................................................................................................................ 6
Accessing Additional Options from the Main Menu .............................................7
Accessing the Main Menu.................................................................................................................. 7
Selecting Stimulation Areas to Modify Programs............................................................................... 7
Saving Modied Programs............................................................................................................... 10
Restoring Programs..........................................................................................................................11
Copying Programs: .......................................................................................................................... 12
Deleting Programs ........................................................................................................................... 13
Accessing System Settings...................................................................................14
Remote Settings .............................................................................................................................. 14
System Info...................................................................................................................................... 17
Accessing the Clinician Menu...............................................................................19
Impedances ..................................................................................................................................... 22
Reset Stimulator .............................................................................................................................. 22
Exit Clinician Mode .......................................................................................................................... 23
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
Icon Description and Index....................................................................................27

Clinician Remote Control Directions for Use
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Product Model Numbers
SC-5532-1 Remote Control Kit
Refer to the Indications for Use for indications and related information.
Refer to the appropriate Information for Prescribers manual for contraindications, warnings, precautions,
adverse events summary, Physician instructions, storage and handling, component disposal, and
contact information for Boston Scientic. Refer to the Labeling Symbols Addendum for an explanation
of Labeling Symbols.
Refer to the following Directions for Use (DFU) for device specic instructions not included in this
manual: Precision Spectra™ System Implantable Pulse Generator DFU, Clinician Trial Manual,
Surgical Leads DFU, Percutaneous Leads DFU, Precision Spectra System Programming Manual, and
Programming Wand DFU.
Refer to the Limited Warranty for warranty information.
For FCC rules and for clinical studies supporting the clinical use of the neurostimulation system,
refer to the Information for Prescribers manual.

Description
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Description
The Precision Spectra™ Remote Control (RC) is a handheld device that allows you to communicate
with and control the Precision Spectra stimulator.
Basic Operation
The RC communicates with the Stimulator through a radio frequency (RF) telemetry link from a
distance of up to 91.4 cm (36 inches).
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 English text screens or Iconic screens. Refer to “Languages” on page 16
for additional instructions.
Note: Throughout this manual the English text screen is shown paired with the corresponding Iconic
screen.
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.

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2. Press the Minus button to decrease the level of stimulation.
3. Press the Plus button to increase the level of stimulation.
Program Selection and Activation
1. Press the button on the left-hand 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 and Down Arrow buttons to navigate to the desired Program.
4. Press the Right Arrow button to Select the Program.

Basic Operation
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Stimulator and RC Battery Status
The icon at the top left of the Home screen indicates the charge level of the RC battery. The
icon at the top right of the Home screen indicates the charge level of the Stimulator battery (right).
The RC will display messages reminding you to recharge the RC or the Stimulator if the battery power
is low.
Charge
Remote Now
Charge
Stimulator
Now
Press
to continue.
Recharging the RC
Recharge the RC battery by connecting the RC to the USB-Power Supply provided with the RC.

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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-hand 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-hand side of the RC.
or
From the Main Menu screen, select Programs
2. Select Save. The Save ? screen displays.
3. Select Yes - Save
or
Select No - 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-hand 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-hand 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.
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-hand 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.
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:
• English language text screens
• Iconic screens
From the Remote Settings menu:
1. Select Languages.
English
?
2. Select the 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.
Serial Number
Model Number
Boot Version
Firmware Version
...
The Remote Info screen displays the following information:
• Serial Number
• Model Number
• Boot Version
• Firmware Version

Accessing System Settings
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2. Select More to view additional Remote Info.
LCD Boot Version
LCD Firmware
The Remote Info screen displays the following additional 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 compartment cover on the Trial Stimulator.

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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. It also allows you to use the Remote Control without any of the lockouts that
may have been programmed by the Clinician Programmer (e.g., Main Menu, Programs, 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 displays. If the password is correct, the
Clinician Menu displays.
Note: If the remote is not linked to a Stimulator, the Stimulator Search option displays on the Clinician
Menu instead of the Clear Link option.