Boston Scientific Bionic Navigator 3d NM-7153-11A Owner's manual

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Programming Manual
Manuel de programmation
Programmierhandbuch
Programmeerhandleiding
Bionic Navigator™ 3D
System Programming
Manual

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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.
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, 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 as listed on
your Reference Guide.
Product Model Numbers
Model Number Description
NM-7153-11A Clinician Programmer
NM-7153-11AR Clinician Programmer (Refurbished)
NM-7153-30* Clinician Programmer
NM-7153-30R* Clinician Programmer (Refurbished)
*Applicable after installation of 9028372-110 software.

Table of Contents
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Table of Contents
Introduction .............................................................................................................. 1
Setting Up.................................................................................................................. 2
Connecting the Programming Wand to the CP ..................................................................................3
Starting a Session .................................................................................................... 4
Main Screen .......................................................................................................................................4
Entering Patient Information ..............................................................................................................7
Changing Patients ..............................................................................................................................9
Dening the Patient’s Pain ..............................................................................................................10
Conguring the CP and Stimulator....................................................................... 12
Connecting to a Stimulator ...............................................................................................................12
Assigning a Patient to a Stimulator ..................................................................................................16
Choosing a Patient Record to Use ...................................................................................................17
Disassociating a Patient ...................................................................................................................18
Viewing the Programming Connection Status .................................................................................18
Displaying CP and Programming Wand Information ........................................................................19
Conguring Leads ............................................................................................................................21
Changing a Lead’s Orientation on the Lead Placement Panel ........................................................26
Assigning a Lead to a Group ...........................................................................................................27
Using LeadSync™ Technology ........................................................................................................28
Measuring Impedances ....................................................................................................................33
Programming the Patient....................................................................................... 35
Precision Spectra Programmable Parameters ................................................................................35
Maximum Current Amplitude per Electrode Vs Impedance
(for all leads other than the 4x8 Surgical Lead) ...............................................................................36
Maximum Current Amplitude per Electrode Vs Impedance
(for the 4x8 Surgical Lead) ...............................................................................................................36
Maximum Amplitude Based on Frequency and Pulse Width
(for all leads other than the 4x8 Surgical Lead) ...............................................................................37
Maximum Amplitude Based on Frequency and Pulse Width
(for the 4x8 Surgical Lead) ...............................................................................................................37
Precision Novi and Precision Montage MRI Programmable Parameters ........................................38
Maximum Current Amplitude per Electrode Vs Impedance ............................................................38
Maximum Amplitude Based on Frequency and Pulse Width ...........................................................39
Mapping and Programs Screen .......................................................................................................40
Overview ..........................................................................................................................................40
Basic Panel ......................................................................................................................................41

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Parameters Panel ............................................................................................................................42
Full View Tab ....................................................................................................................................44
Selecting the Program .....................................................................................................................45
Electrode Programming ...................................................................................................................46
Using E-Troll Mode ..........................................................................................................................47
Using Navigate Mode ......................................................................................................................47
Using Manual Mode ........................................................................................................................48
Increasing/Decreasing Amplitude ....................................................................................................49
Increasing/Decreasing Pulse Width .................................................................................................49
Increasing/Decreasing Rate .............................................................................................................49
Using the Keyboard Shortcuts .........................................................................................................50
Understanding Areas Slots ..............................................................................................................50
Turning Stimulation ON or OFF .......................................................................................................51
Understanding the Advanced Options ............................................................................................53
Understanding the Program Options ...............................................................................................54
Dening Cycling, Maximum Amplitude, and Ramp Up Time ............................................................55
Specifying Remote Control Locks ....................................................................................................57
Copying Areas to other Area Slots ...................................................................................................58
Clearing an Area ..............................................................................................................................59
Temporarily Saving Areas ................................................................................................................59
Completing the Programming Session ............................................................................................61
Notes........................................................................................................................62
Tools ........................................................................................................................63
System Defaults ...............................................................................................................................63
Backup Data/Logs ............................................................................................................................65
Update Leads ...................................................................................................................................66
Reports.................................................................................................................... 68
Troubleshooting ..................................................................................................... 70
Glossary .................................................................................................................. 71
References .............................................................................................................. 75

Introduction
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Introduction
Welcome to the Bionic Navigator™ 3D Clinician Programmer (CP) by Boston Scientific. Your CP’s
software allows you to set and adjust stimulation parameters for your Spinal Cord Stimulator System.
The goal of this Programming Manual is to provide useful information and instruction to users of the CP.
The user interface is designed so that you can navigate through the user interface systematically.
A typical programming session consists of the following sequential procedures:
Create a profile for the patient
↓
Connect to the Stimulator
↓
Connect and Configure Leads
↓
Map and Save Stimulation Programs
In the following pages, you will learn basic concepts that will allow you to complete the above
procedures as well as perform additional functions, such as creating reports.
If you have any issues, please refer to the Troubleshooting section.
NOTE: Screens depicted in this manual may differ slightly from the screens on your Bionic Navigator
3D Clinician Programmer.

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Setting Up
Figure 1: Clinician Programmer (CP) and Programming Wand
The CP communicates with the Stimulator via a Programming Wand. The Programming Wand
uses a radio frequency (RF) link to communicate with the Stimulator. Programs can be created and
downloaded to the CP for previewing, activating, and changing stimulation parameters. Stimulation
programs can also be saved to the Stimulator.
CAUTION: Use only Precision Spectra™, Precision Novi™ and Precision Montage™ MRI system
components of your Boston Scientic spinal cord stimulator system with the Bionic Navigator
3D System. Failure to do so may result in the inability to program the Stimulator.
CAUTION: The CP is not equipment for the patient environment as dened by IEC 60601-1. The
CP and the person using the CP should not be in contact with the patient while programming.

Setting Up
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Note: See ASUS Eee Slate B121 manuals at ww.asus.com for additional instructions. If desired, an
external monitor can be connected for easier viewing by multiple people. For ASUS, insert a mini HDMI
cable into the port to connect to a high-denition multimedia interface (HDMI).
Connecting the Programming Wand to the CP
1. Insert the Mini-B USB end of the USB connector cable into the Mini-B USB port on the side
of the Programming Wand.
2. Insert the Standard-A end of the USB connector cable into the Standard-A USB port on
the CP.

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Starting a Session
Power [ON] the CP to display the Neuromodulation desktop. Select the icon to launch the
Bionic Navigator 3D software. Upon launch, the Main Screen displays. To access the Main screen at
any other time, select any accessible space on the gray Main screen expander bar at the top of the
screen.
Main Screen
Figure 2: Main Screen
The components on the Main screen are global (displayed on all screens) and are described in Table 1.

Starting a Session
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Table 1: Global Components
Component Description
1 Patient
Expander Bar
Displays the current patient’s name and pain scale.
Select the Patient Expander Bar to display the Patient Info screen
which allows you to:
• Create a new Patient Prole
• Enter/Edit Patient Information
• Record a patient’s Pain Scale
2 Configuration
Expander Bar
Select the Configuration Expander Bar to display the Configuration
screen which allows you to:
• Connect to a Stimulator
• Dene lead congurations
• Check impedances
The CP’s connection status is also indicated at the right of this
expander bar. Green indicates a connection, while the red x indicates
a connection has not been made.
3 Mapping and
Programs Expander
Bar
Select the Mapping and Programs Expander Bar to display the
Mapping and Programs screen which allows you to set up and
configure stimulation programs

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4 Stimulation On/Off
Button
The Stimulation On/Off button displays at the top of every screen
and changes color to indicate connection status as well as stimulation
On/Off status:
The CP is not connected to a Stimulator.
The CP is connected to a Stimulator; and stimulation is OFF.
The CP is connected to a Stimulator, and stimulation is ON.
When the CP is connected to a Stimulator, you can turn stimulation on
or off at anytime by selecting the Stimulation On/Off button.
5 Notes Displays the Notes pop-up window which allows you to:
• Select a reason for the visit.
• Record Session Notes.
• View the Notes History.
6 Reports Displays the Reports pop-up window which allows you to generate
and print customizable reports.
7 Tools Displays the Tools pop-up window which allows you to:
• Increase or decrease the default value for pulse width and rate.
• Specify which parameters are locked out on the remote control.
• Backup data and logs.
• Enable or disable leads.
8
Quit
Displays the Quit pop-up window which allows you to:
• Disconnect from the Stimulator.
• Exit the Clinician Programmer Software
• Turn Off the CP.

Starting a Session
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Entering Patient Information
From the Main screen, select the Patient Expander Bar to access the Patient Info screen (default) and
the Pain Scale screen.
Figure 3: Patient Info Screen
Note: Required elds on the screen above are indicated by an asterisk.
The Patient Info and Pain Scale buttons on the left side of the Patient screen allow you
to toggle between the Patient Info screen and the Pain Scale screen. See “Defining a Patient’s Pain” for
additional information.
To enter/edit information on the Patient (Information) screen:
1. Type the Patient/Chart ID (Optional)
2. Type the Patient’s Last Name.
3. Type the Patient’s First Name.

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4. Select the calendar icon to select the Date of Birth. Tip: To quickly change the birth year,
click or tap twice on the [Month, Year] at the top of the calendar to be able to scroll (left-right)
to different decades.
5. Select the Patient’s Gender: (Optional)
a. Female
b. Male
6. Type the Patient’s Address. (Optional)
7. Type the name of the Physician, or select from the drop-down list. (Optional)
Note: This text box is enabled only when the CP is connected to a Stimulator. See Connecting
to a Stimulator in this manual.
8. Type the Diagnosis, or select from the drop-down list. (Optional)
Note: This text box is enabled only when the CP is connected to a Stimulator. See Connecting
to a Stimulator in this manual.
9. Select the Save button to save the information entered.
Important: Ofine changes will only be saved on the CP.
Note: You can revert to the last saved version of the patient’s information by selecting the
Revert button on the Patient (Information) screen.
Note: To create a new patient record, select the Create New Patient button and repeat steps
1-9 as appropriate.

Starting a Session
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Changing Patients
You can choose to display information for a different patient, when the CP is not connected to a
stimulator, by selecting the Change Patient button on the Patient Info screen. The Select a patient
pop-up window will be displayed:
Figure 4: Select a Patient Pop-Up Window
Note: Use the scroll bars at the bottom and side of the pop-up window to view all of the available
information.
To Change a Patient:
1. Type any part of the Patient’s name in the Search text box to narrow the list.
2. Select the Patient’s name from the list.
3. Select the Assign Patient button.

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Dening the Patient’s Pain
From the Patient Info screen, select the Pain Scale button to display the Pain Scale screen.
Note: A Stimulator must be connected to the CP in order to access the Pain Scale screen. Refer to
“Connecting to a Stimulator”.
Figure 5: Pain Scale Screen
Note: As indicated on the Pain Scale screen in Figure 5, 0represents No Pain and 10 represents the
Worst Pain Imaginable.

Starting a Session
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To enter a Patient’s Pain Scale:
1. Select the Sliding Number button on the Stimulation ON bar and slide it to the number that
best represents the Patient’s level of pain when stimulation is ON.
2. Select the Sliding Number button on the Stimulation OFF bar and slide it to the number that
best represents the Patient’s level of pain when stimulation is OFF.
Note: Stimulation can be turned on and off at any time, by selecting the Stimulation On/Off
button at the top of the screen.

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Conguring the CP and Stimulator
The Configuration screen allows you to set up the CP and Stimulator for programming. On the
Configuration screen you can:
• Establish a programming connection between the CP and the Stimulator.
• Check the status of the programming connection.
• Identify which leads are used and record where they were implanted.
• Set up the connection between the leads and the Stimulator ports.
• Run LeadSync™ to identify and apply the relative offset of leads.
• Check the impedances of each contact.
Connecting to a Stimulator
In order to program a Stimulator, you must connect the CP to that Stimulator.
1. Select the Conguration Expander bar to display the Connect screen.
2. Select the button to create a programming connection between the desired
Stimulator and CP. The Connection Status Indicator displays green when a valid connection
is made.
Note: After connecting the desired Stimulator and CP, a Remote Control (and in the case of an ETS,
also the ETS On/Off button) can be used to modify the Stimulator’s settings” (e.g., turn stimulation ON
or OFF). Any subsequent change to the Stimulator from the CP will transfer the settings displayed on
the CP to the Stimulator.
Caution: If the Remote Control is used to turn stimulation OFF during programming, turn the
Stimulation On/Off Button on the CP to OFF before resuming programming. This will ensure that
the CP is synchronized with the stimulation status of the Stimulator.

Conguring the CP and Stimulator
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Figure 6: Connection Screen
Component Description
1CP to Wand to
Stimulator Connection
Displays the status of the connections between the CP, Wand, and
Stimulator.
2Rescan Button Select this button to rescan the vicinity for available Stimulators.
(Disabled if CP is already connected to a Stimulator)

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3 Stimulator Information
Note: When the
Connect screen is
rst accessed, the
CP scans the vicinity
to locate and lists all
available Stimulators.
Displays the following:
• Type of Stimulator (Trial Stimulator or Implantable Pulse
Generator)
• Model Number
• Serial Number
• Firmware Version Number
• Stimulator service life information, if within the End of Battery
life or ERI (elective replacement indicator) period for non-
rechargeable stimulators or within 6 months of the planned end of
service life date for all stimulators.
4 Patient Information Last Name, First Name, and Date of Birth are displayed if the
Stimulator is assigned to a patient. If not, these fields are blank.
Refer to “Assigning a Patient to a Stimulator”.
5Disassociate Button Select this button to disassociate the displayed patient from the
connected stimulator.
6Connection Status
Indicator
The indicator displays a green filled circle if the Stimulator is
connected to the CP.
7Connect or
Disconnect Button
When no stimulator is connected, this button reads “Connect”. When
a Stimulator is connected, this button reads “Disconnect”.
Select the button to Connect or Disconnect the desired stimulator.

Conguring the CP and Stimulator
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Figure 7: Connection Screen after Trial Stimulator is Connected

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Assigning a Patient to a Stimulator
A patient profile must be associated with a Stimulator before a Stimulator can be programmed. If a
Stimulator is not assigned a patient profile, the software prompts you to assign a patient profile from the
patient profile database on the CP.
Figure 8: Change Patient Dialog Box
1. If desired, type the rst name, last name or Patient/Chart ID in the Search text box to lter
the list of Patients.
2. Select the appropriate Patient.
3. Select the Assign Patient button.