Boston Scientific Vercise 92290361-01 User manual

VERCISE DBS
PROGRAMMING
QUICK START GUIDE
Boston Scientific
Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia, CA 91355 USA
[phone] in US and Canada
[phone], [phone] Fax
[phone] TTY
www.bostonscientific.com
Email: [email protected]
Boston Scientific (Australia) Pty Ltd
PO Box 332
BOTANY
NSW 1455
Australia
Free Phone [phone]
Free Fax [phone]
Boston Scientific Limited
Ballybrit Business Park
Galway, Ireland
T: [phone]
F: [phone]
SAVING A PROGRAM
The currently active program can be saved to one of the four program slots.
To save a program to the Stimulator:
1. Name the program by clicking “Edit” at the top of the left panel, typing a program name,
and selecting the “check mark.”
2. Click a program slot on the right of the screen to which you want to save the program. You can select
a blank slot to save a program to, or you can select a slot that already has a program to overwrite it.
3. Click .
The currently active program will be saved to the selected program slot.
NOTE: the symbol in the Remote Control panel indicates last activated or saved program.
4. Click to end programming session.
UNDERSTANDING THE PROGRAM SLOTS
The program currently running on the Stimulator is displayed on the left panel.
On the right side of the screen, the four program slots are displayed.
Currently Active
Program Slot
Remote Control
Program Slot
MANAGING PROGRAMS
To get to the Remote Control screen:
1. Click from the Programming screen.
92290361-01
Content: 92290376 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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TABLE OF
CONTENTS
Linking a Remote Control to a Stimulator................................. 1
De-linking a Remote Control from a Stimulator....................... 1
Setting Up................................................................................. 2
Creating a New Patient............................................................ 2
Selecting an Existing Patient.................................................... 3
Programming the Patient.......................................................... 3
Selecting Contacts................................................................... 4
E-Troll Mode............................................................................. 4
Custom Mode........................................................................... 5
Turning Stimulation On and Off for Individual Areas............... 5
Increasing and Decreasing the Amplitude............................... 6
Increasing and Decreasing the Pulse Width............................ 6
Increasing and Decreasing the Rate......................................... 7
Programming with Multiple Rates............................................ 7
Managing Programs.................................................................. 8
Understanding the Program Slots............................................. 8
Saving a Program...................................................................... 8
GUARANTEES
Boston Scientific 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, contraindications, warnings, precautions, adverse events summary,
sterilization, component disposal, storage and handling, labeling symbols, warranty
information and other device specific information not included in this manual,
refer to the Vercise Physician Manual.
1) The rate is limited to 255 Hz for a given area.
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LINKING A REMOTE CONTROL TO A STIMULATOR
To link a Remote Control that has been previously linked to a different Stimulator, you must first de-link
the Remote Control from the original Stimulator (see De-linking a Remote Control from a Stimulator
below) and then link the Remote Control to the new Stimulator.
To link a Remote Control to a Stimulator:
1. Press and hold the Pbutton to unlock the Remote Control. The Remote Control will ask
if you want to link it to a Stimulator.
2. Position the Remote Control within 18 inches (45 cm) of the Stimulator
3. Press the Pbutton to link the Remote Control with the Stimulator or cancel
by pressing the button.
4. Confirm the link by pressing the Pbutton or cancel by pressing the button.
DE-LINKING A REMOTE CONTROL
FROM A STIMULATOR
To de-link a Remote Control from a Stimulator:
1. Press and hold the Pbutton to unlock the Remote Control.
2. Enter the Clinician’s screen on the Remote Control by pressing and holding both
the and Pbuttons simultaneously.
3. Scroll down to “Clear Link” and select “Clear Link” by pressing the Pbutton.
4. Confirm that you want to clear the link by pressing the Pbutton or cancel by pressing the button.
5. Enter the password A-B-C.
NOTE: To re-link the Remote Control,
see Linking a Remote Control to a Stimulator above.
SETTING UP
To connect the Remote Control to the Clinician Programmer:
1. Plug the USB to Serial cable into a USB port on the Clinician Programmer.
2. Connect the USB to Serial cable to the matching end of the IR Interface.
3. Orient the large surface of the Remote Control parallel to the large surface of the Stimulator
4. Insert the IR Interface and Remote Control into the plastic holder to keep the IR windows aligned,
as shown below:
Enter the Clinician’s screen on the Remote Control by pressing and holding the and Pbuttons simultaneously.
Press the P button to select “CP Mode.”
• The Remote Control will inform you that it is ready to communicate with the Clinician Programmer.
CREATING A NEW PATIENT
To create a new patient:
1. Click the down arrow on the right side of the Patient drop-down menu.
2. Select New Patient.
• The Profile screen will automatically be displayed.
3. Fill in the patient’s information.
4. Required fields are denoted by bold text.
5. Click Finish to save the information.
6. Click the down arrow on the right side of the Reason for Visit drop-down menu.
7. Select the appropriate reason for the visit.
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SELECTING AN EXISTING PATIENT
The Clinician Programmer will automatically recognize a patient if you have previously
linked the Clinician Programmer to the patient’s hardware.
To select an existing patient:
1. Click the down arrow on the right side of the Patient pull-down menu.
2. Select an appropriate patient from the alphabetized list.
3. Click the down arrow on the right side of the Reason for Visit pull-down menu.
4. Select the appropriate reason for the visit.
PROGRAMMING THE PATIENT
1. To get to the Programming screen, select at the bottom center of any screen.
2. To check the Lead impedances:
1. Click while in the Program screen.
NOTE: All measured impedances are saved into the Clinician Programmer database.
2. To exit, click
3. To select an Area:
1. Click on the desired Area control box on the left of the Programming screen, as highlighted
in the image below.
4. To name an Area:
1. Make sure the Area you wish to name is selected.
2. Click on the Area’s name.
3. Edit the text.
• Area names may not exceed 8 characters in length.
4. Click to save the changes or to exit without saving your changes.
E-TROLL MODE
E-Troll Mode is an enhanced way of conducting a monopolar review.
To E-Troll along the lead:
1. Switch to E-Troll Mode by clicking in the middle of the screen.
2. Select a contact to assign it as a cathode and adjust the amplitude.
3. Use the and buttons in the E-Troll panel to incrementally steer the stimulation focus.
SELECTING CONTACTS
You may program the patient either by manually selecting anodes and cathodes in Custom Mode or
automatically trolling the stimulation field along the lead in E-Troll Mode.
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CUSTOM MODE
Custom Mode allows you to manually select contacts to be anodes or cathodes.
If necessary (i.e., to switch to Custom Mode from E-Troll Mode), press the button at the top
of the middle panel on the Programming screen.
1. Click on the contact to select that contact.
2. Click on the selected contact to turn the contact into an anode.
Click on the selected contact again to turn the contact into a cathode.
Click on the selected contact again to turn the contact OFF (blank).
Contact polarity options include anode (+), cathode (-), and OFF (blank).
3. Repeat steps 1-2 until all desired contacts are selected.
TURNING STIMULATION ON AND OFF
FOR INDIVIDUAL AREAS
To turn ON stimulation for an Area:
1. Make sure the Area you wish to turn on is selected.
NOTE: To initially turn on stimulation for an Area, that area must first be configured with
at least one cathode.
2. Click the button of the selected Area to turn stimulation ON.
INCREASING AND DECREASING THE AMPLITUDE
1. To increase the amplitude, click the up arrows above the AMP label on the Programming screen.
2. To decrease the amplitude, click the down arrows above the AMP label.
To turn OFF stimulation for an Area:
1. Make sure the Area you wish to turn off is selected.
2. Click the button of the selected Area to turn stimulation OFF.
INCREASING AND DECREASING THE PULSE WIDTH
1. To increase the pulse width, click the button below the PW label.
2. To decrease the pulse width, click the button below the PW label.
INCREASING AND DECREASING THE RATE
1. To increase the rate, click the button below the RATE label.
2. To decrease the rate, click the button below the RATE label.
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AREA 1 (90 μs): AREA 2 (90 μs):
119 Hz 71 Hz
159 Hz
74 Hz
179 Hz
79 Hz
198 Hz
85 Hz
238 Hz
89 Hz 99 Hz 149 Hz 119 Hz
128 Hz 85 Hz 128 Hz 170 Hz 255 Hz
130 Hz 74 Hz 104 Hz 130 Hz 174 Hz
132 Hz 76 Hz 79 Hz 99 Hz 132 Hz 198 Hz
136 Hz 136 Hz 204 Hz
139 Hz 79 Hz 104 Hz 139 Hz 185 Hz 208 Hz
154 Hz 116 Hz 154 Hz 231 Hz
159 Hz 79 Hz 95 Hz 119 Hz 159 Hz 238 Hz
179 Hz 71 Hz 89 Hz 119 Hz 179 Hz
185 Hz 79 Hz 139 Hz 185 Hz
190 Hz 71 Hz 95 Hz 143 Hz 190 Hz
AREA 1 (30 μs): AREA 2 (30 μs):
119 Hz 71 Hz
119 Hz
179 Hz
74 Hz
132 Hz
190 Hz
79 Hz
136 Hz
198 Hz
85 Hz
139 Hz
208 Hz
89 Hz
143 Hz
238 Hz
95 Hz
149 Hz
99 Hz
159 Hz
104 Hz
170 Hz
128 Hz 74 Hz
146 Hz
85 Hz
149 Hz
89 Hz
170 Hz
99 Hz
179 Hz
112 Hz
204 Hz
113 Hz
223 Hz
128 Hz
255 Hz
130 Hz 74 Hz 104 Hz 112 Hz 116 Hz 130 Hz 149 Hz 174 Hz 208 Hz
132 Hz 74 Hz
132 Hz
231 Hz
76 Hz
149 Hz
238 Hz
79 Hz
154 Hz
85 Hz
159 Hz
99 Hz
170 Hz
113 Hz
176 Hz
116 Hz
185 Hz
119 Hz
198 Hz
136 Hz 76 Hz
149 Hz
79 Hz
190 Hz
85 Hz
204 Hz
95 Hz
227 Hz
113 Hz
238 Hz
119 Hz 136 Hz 159 Hz
139 Hz 79 Hz
159 Hz
89 Hz
174 Hz
99 Hz
179 Hz
104 Hz
185 Hz
116 Hz
198 Hz
119 Hz
208 Hz
139 Hz
231 Hz
154 Hz
179 Hz 71 Hz
128 Hz
74 Hz
139 Hz
79 Hz
143 Hz
89 Hz
149 Hz
99 Hz
179 Hz
104 Hz
208 Hz
112 Hz
223 Hz
119 Hz
238 Hz
185 Hz 79 Hz 116 Hz 132 Hz 139 Hz 154 Hz 159 Hz 185 Hz 231 Hz
190 Hz 71 Hz
238 Hz
79 Hz 95 Hz 119 Hz 136 Hz 143 Hz 159 Hz 190 Hz
154 Hz 99 Hz
198 Hz
116 Hz
231 Hz
132 Hz 139 Hz 154 Hz 174 Hz 176 Hz 185 Hz
159 Hz 79 Hz
159 Hz
95 Hz
185 Hz
99 Hz
190 Hz
113 Hz
198 Hz
119 Hz
238 Hz
132 Hz 136 Hz 139 Hz
AREA 1 (60 μs): AREA 2 (60 μs):
119 Hz 71 Hz
99 Hz
159 Hz
74 Hz
104 Hz
179 Hz
79 Hz
119 Hz
198 Hz
85 Hz
139 Hz
238 Hz
89 Hz
143 Hz
159 Hz
95 Hz
149 Hz
128 Hz 74 Hz
149 Hz
85 Hz
170 Hz
89 Hz
179 Hz
99 Hz
223 Hz
112 Hz
255 Hz
128 Hz
130 Hz 74 Hz 104 Hz 112 Hz 130 Hz 174 Hz
132 Hz 76 Hz 79 Hz 99 Hz 113 Hz 132 Hz 159 Hz 176 Hz 198 Hz
136 Hz 76 Hz 85 Hz 113 Hz 136 Hz 170 Hz 204 Hz 227 Hz
139 Hz 79 Hz
174 Hz
104 Hz
185 Hz
116 Hz
208 Hz
119 Hz
231 Hz
139 Hz
179 Hz 71 Hz
128 Hz
74 Hz
143 Hz
79 Hz
149 Hz
89 Hz
179 Hz
99 Hz
223 Hz
112 Hz
238 Hz
119 Hz
130 Hz 79 Hz 139 Hz 185 Hz
132 Hz 71 Hz 95 Hz 143 Hz 190 Hz
154 Hz 116 Hz 154 Hz 231 Hz
159 Hz 79 Hz
132 Hz
95 Hz
159 Hz
99 Hz
198 Hz
113 Hz
238 Hz
119 Hz
PROGRAMMING TWO AREAS WITH DIFFERENT RATES
The Vercise DBS System allows two Areas to be programmed with different rates (or frequencies).
This feature allows you to simultaneously stimulate two areas of the brain with different rates.
To program two different Areas with different rates:
1. Turn on one Area and turn off all the other Areas.
2. Select the desired rate for the first Area.
3. Turn on a second Area.
4. Select the desired rate for the second Area.
NOTE: You will have a limited number of rates available for programming when selecting the rate for the second Area.
NOTE: Modifying the rate of either Area will alter the available rates for the other Area.
NOTE: When establishing two Areas with different rates, the first Area must be on
while the rate for the second Area is programmed.
PROGRAMMING MULTIPLE AREAS WITH THE SAME RATE
The Vericise DBS System allows two Areas to be programmed with the same rate (or frequency).
If more than two Areas are turned on, then all Areas must have the same rate.
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