Boston Scientific Vercise DBS 4 User manual

Vercise™ DBS
Remote Control 4
Handbook
92441284-01
CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician.
92441284-01
Content: MP92441284-01 REV A

Vercise™ DBS Remote Control 4 Handbook, 92441284-01
Trademarks
All trademarks are the property of their respective holders.
The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG,
Inc. and any use of such marks by Boston Scientific Neuromodulation Corporation is under
license.
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.
Drawings are for illustration purposes only.
Technical Support
There are no user serviceable parts. If you have a specific question or issue, contact your
healthcare provider. If you need to contact Boston Scientific for any other reason, call
(833) DBS‑INFO or (833) 327‑4636.

Vercise™ DBS Remote Control 4 Handbook, 92441284-01
Additional Information
Refer to the Information for Patients manual for additional information on your Deep Brain
Stimulation System, such as indications for use, contraindications, warnings, precautions,
adverse effects, storage and handling, and device disposal. For charging instructions for
rechargeable Stimulators, refer to the Vercise DBS Charging Handbook .
Note: Images of the Remote Control Home Screen within this manual are representative of
those displayed for a rechargeable system unless specified otherwise. The Home Screen
for non‑rechargeable Stimulators does not include the battery level of the Stimulator.
Product Model Numbers
Model Description
DB‑5572‑1 Vercise DBS Remote Control 4 Kit
DB‑5270 Vercise DBS Remote Control 4
NM‑6210 Remote Control Holster
NM‑6315, DB‑6315 USB Power Supply
NM‑6600 Patient Travel Case

Page 4
Vercise™ DBS Remote Control 4 Handbook, 92441284-01
Introduction 6
How To Use Programs 19
About System Settings 29
Reminders and Messages 47
Using the Remote Control 11
Troubleshooting 55
Table of Contents
About MRI Mode 34

INTRODUCTION
Page 5
Vercise™ DBS Remote Control 4 Handbook, 92441284-01
This manual has been color‑coded to help you use the
Remote Control while referencing the manual.
Each section is labeled
and color‑coded

Page 6
Vercise™ DBS Remote Control 4 Handbook, 92441284-01
The Remote Control is a hand‑held device
that allows you to communicate with your
Stimulator. Typically, you will be using the
Remote Control to turn stimulation ON or OFF.
Your Remote Control will also display
important messages about your Stimulator
and Remote Control battery status. You
should check your Remote Control at least
once per month. The Remote Control will not
communicate with an implanted rechargeable
Stimulator during charging.
Keep your Remote Control with you at all
times. Be sure to bring your Remote Control
with you to appointments with your physician,
including visits to program your Stimulator.
55
%
1
Morning
Level
Main Menu
i-Sculpt
Restore to
Clinic Settings
SelectBack
Spread
EGL Scan
French
Accept
Spread
120
µS
Strength
Programs
Programs
P
Stimulation Areas
Main Menu
System Settings
Programs
Stimulation Areas
Main Menu
System Settings
Programs
Stimulation Areas
Main Menu
System Settings
Morning
1
Night
2
Program 3
3
4
Options
Change Programs
Program / copy to: Available program slot
Active Program
Empty Program Slot / copy to: Clinician program can not be overwritten
Save
Copy to ...
Copy to ...
Delete
Program
Activated
Program
Saved
Program
Restored
Program
Deleted
Yes
No
Restore
Program 1
‘Morning’
to Clinic Settings?
Yes
No
Overwrite
Program 4
‘Empty’
Yes
No
Delete
‘Program 3’ ?
Stimulation Areas Lower Back
Lower Back
A
Hip
B
Left Leg
C
Left Leg 2
D
Sensation
i-Sculpt
Compare
Lower Back
Strength
4.6
mA
Lower Back
Sensation
200
Hz
Lower BackLower Back
Return to i-Sculpt
Discard and Exit
Compare to Old
Lower Back
Stimulating
New
Settings
Yes
No
Lower Back
Discard
Changes to
‘Lower Back’?
Yes
No
Lower Back
Accept
Changes to
‘Lower Back’?
Press
Side Button
to Unlock
Stimulation
OFF
Stimulation
ON
Unlock
All top bars change to red when Adv. Mode is activated.
Home
Programs P
System Settings
Remote Settings
System Info
Clinician Mode
Remote Settings
Alert Volume
Screen Brightness
Languages
Alert Volume Screen Brightness
Alert VolumeScreen Brightness
Italian
Spanish
Languages
German
SelectBack
English
English
selected
System Info
Remote Info
Implant Info
Impedances
Remote Info
Serial Number
SC-508392938
Battery Voltage
4.5 V
Battery Status
?
Firmware Version
1.2
Implant Info
Serial Number
SC-508392938
Battery Voltage
4.5 V
Battery Status
?
Implant Type
1.2
Implant Info
Lead Type
M-2357
IPG Temperature
40.3 C
Battery Impedance
?
Reset Counter
1.2
Impedances
1234
1234
1234
1234
1234
1234
1234
1234
1
2
3
4
5
6
7
8
1234
1234
1234
1234
1234
1234
1234
1234
Info
Info
-
Telemetry Test
Info
-
9
10
11
12
13
14
15
16
1234
1234
1234
1234
1234
1234
1234
1234
1
2
3
4
5
6
7
8
1234
1234
1234
1234
1234
1234
1234
1234
9
10
11
12
13
14
15
16
Impedances
EGL Scan
Rescan
Cancel Cancel
4.5
EGL Scan
Rescan
-
Main Menu
85
%
1
Morning
Level
IPG Charge Test
Coil
Detected
Coil Frequency
0123456
Peak Current Found
0123456
ADC
0123456
+-
Single Lead
Selected
Yes
No
Enable
EGL Scan
for iSculpt?
Password Clinician Mode
Adv. Mode: ON
Diagnostics
Impedances
CP Mode
Lock-Out
Clear Link
EGL Scan
Lower Back
Clear Link
to Stimulator
ID 123456
Clear Link
Yes
No
Link This Remote
to Stimulator
ID 123456
Link
Yes
No
Diagnostics
Button Test
LCD Test
Telemetry Test
IPG Charge Test
Select
Lock Out
Spread
Sensation
i-Sculpt
Advanced User
Feeling egarevoChtgnertSaerA
SelectBack
SelectBack
SelectBack SelectBack SelectBack SelectBack SelectBack
SelectBack
SelectBack SelectBack
SelectBack
Back
Strength
4.6
mA
Back
Back Back Select SelectBackReturn SelectBack SelectBack
SelectBack
SelectBack SelectBack
Back Back Back
Back
MoreBack Back
Back Back
MeasureBack
MeasureBack
SelectBack SelectBack
SelectBack SelectBack SelectBack SelectBack SelectBack
Empty
5
Programs
Morning
1
Night
2
Program 3
3
Empty
4
SelectBack
1 1 1
55
%
11
Morning
Level
Main Menu
Stimulation
ON
Stimulation
ON
Stimulation
OFF
Stimulation
OFF
Stimulation
ON
Stimulation
OFF
1 1 1 1 1 1
Compare to New
Lower Back
Stimulating
Old
Settings
SelectBack
1 1 11
4.6
mA
Lower Back
1
Finish
Scroll
Select / Next
Backspace
1
P
A _ _ _ _
Option AOption BOption C
Introduction
CAUTIONS
• Keep the Remote Control
dry. It should not be
exposed to moisture.
• Do not connect the
Remote Control USB port
to any other device except
to the Remote Control
Charger provided with it.
• Keep the Remote Control
away from pets, pests, and
children to avoid damage
to the device.

INTRODUCTION
Page 7
Vercise™ DBS Remote Control 4 Handbook, 92441284-01
Buttons are located on the front and sides of the Remote
Control as shown in the picture.
On the right side of the Remote Control,
you will find the Lock/Unlock button .
On the left side, you will find the HOME
button and Programs button .
On the front of the Remote Control, you
will find the Stimulation ON/OFF button
, and the and buttons that
allow you to adjust features, such as the Remote Control
volume and brightness. Below the Stimulation ON/OFF
button are the Navigation buttons , which allow you
to navigate through various menus.
55
%
1
Morning
Level
Main Menu
i-Sculpt
Restore to
Clinic Settings
SelectBack
Spread
EGL Scan
French
Accept
Spread
120
µS
Strength
Programs
Programs
P
Stimulation Areas
Main Menu
System Settings
Programs
Stimulation Areas
Main Menu
System Settings
Programs
Stimulation Areas
Main Menu
System Settings
Morning
1
Night
2
Program 3
3
4
Options
Change Programs
Program / copy to: Available program slot
Active Program
Empty Program Slot / copy to: Clinician program can not be overwritten
Save
Copy to ...
Copy to ...
Delete
Program
Activated
Program
Saved
Program
Restored
Program
Deleted
Yes
No
Restore
Program 1
‘Morning’
to Clinic Settings?
Yes
No
Overwrite
Program 4
‘Empty’
Yes
No
Delete
‘Program 3’ ?
Stimulation Areas Lower Back
Lower Back
A
Hip
B
Left Leg
C
Left Leg 2
D
Sensation
i-Sculpt
Compare
Lower Back
Strength
4.6
mA
Lower Back
Sensation
200
Hz
Lower BackLower Back
Return to i-Sculpt
Discard and Exit
Compare to Old
Lower Back
Stimulating
New
Settings
Yes
No
Lower Back
Discard
Changes to
‘Lower Back’?
Yes
No
Lower Back
Accept
Changes to
‘Lower Back’?
Press
Side Button
to Unlock
Stimulation
OFF
Stimulation
ON
Unlock
All top bars change to red when Adv. Mode is activated.
Home
Programs
P
System Settings
Remote Settings
System Info
Clinician Mode
Remote Settings
Alert Volume
Screen Brightness
Languages
Alert Volume Screen Brightness
Alert VolumeScreen Brightness
Italian
Spanish
Languages
German
SelectBack
English
English
selected
System Info
Remote Info
Implant Info
Impedances
Remote Info
Serial Number
SC-508392938
Battery Voltage
4.5 V
Battery Status
?
Firmware Version
1.2
Implant Info
Serial Number
SC-508392938
Battery Voltage
4.5 V
Battery Status
?
Implant Type
1.2
Implant Info
Lead Type
M-2357
IPG Temperature
40.3 C
Battery Impedance
?
Reset Counter
1.2
Impedances
1234
1234
1234
1234
1234
1234
1234
1234
1
2
3
4
5
6
7
8
1234
1234
1234
1234
1234
1234
1234
1234
Info
Info
-
Telemetry Test
Info
-
9
10
11
12
13
14
15
16
1234
1234
1234
1234
1234
1234
1234
1234
1
2
3
4
5
6
7
8
1234
1234
1234
1234
1234
1234
1234
1234
9
10
11
12
13
14
15
16
Impedances
EGL Scan
Rescan
Cancel Cancel
4.5
EGL Scan
Rescan
-
Main Menu
85
%
1
Morning
Level
IPG Charge Test
Coil
Detected
Coil Frequency
0123456
Peak Current Found
0123456
ADC
0123456
+-
Single Lead
Selected
Yes
No
Enable
EGL Scan
for iSculpt?
Password Clinician Mode
Adv. Mode: ON
Diagnostics
Impedances
CP Mode
Lock-Out
Clear Link
EGL Scan
Lower Back
Clear Link
to Stimulator
ID 123456
Clear Link
Yes
No
Link This Remote
to Stimulator
ID 123456
Link
Yes
No
Diagnostics
Button Test
LCD Test
Telemetry Test
IPG Charge Test
Select
Lock Out
Spread
Sensation
i-Sculpt
Advanced User
Feeling egarevoChtgnertSaerA
SelectBack
SelectBack
SelectBack SelectBack SelectBack SelectBack SelectBack
SelectBack
SelectBack SelectBack
SelectBack
Back
Strength
4.6
mA
Back
Back Back Select SelectBackReturn SelectBack SelectBack
SelectBack
SelectBack SelectBack
Back Back Back
Back
MoreBack Back
Back Back
MeasureBack
MeasureBack
SelectBack SelectBack
SelectBack SelectBack SelectBack SelectBack SelectBack
Empty
5
Programs
Morning
1
Night
2
Program 3
3
Empty
4
SelectBack
1 1 1
55
%
11
Morning
Level
Main Menu
Stimulation
ON
Stimulation
ON
Stimulation
OFF
Stimulation
OFF
Stimulation
ON
Stimulation
OFF
1 1 1 1 1 1
Compare to New
Lower Back
Stimulating
Old
Settings
SelectBack
1 1 11
4.6
mA
Lower Back
1
Finish
Scroll
Select / Next
Backspace
1
P
A _ _ _ _
Option A Option B Option C
Remote Control Buttons
Home
Programs
Lock /
Unlock
Navigation
Buttons
Increase (+)
Decrease (‑)
Stimulation
ON/OFF
Button

Page 8
Vercise™ DBS Remote Control 4 Handbook, 92441284-01
The Remote Control screen displays menus, icons, status messages, error messages, and other
information.
When the Remote Control is not in use (for example, the buttons are not being pressed), the
screen automatically darkens after approximately 1 minute to preserve the Remote Control’s
battery. The screen lights up when the Remote Control is unlocked and remains on while the
Remote Control is being used. To change the brightness of the screen, see the “About System
Settings” section of this manual.
Typically, when the Remote Control is in use, the Home screen displays.
CROP IN TIGHTER SO
SCREEN IS MORE LEGIBLE
CROP IN TIGHTER SO
SCREEN IS MORE LEGIBLE
CROP IN TIGHTER SO
SCREEN IS MORE LEGIBLE
CROP IN TIGHTER SO
SCREEN IS MORE LEGIBLE
Charging
Remote
Alert Volume
Back
Remote Control Screen

INTRODUCTION
Page 9
Vercise™ DBS Remote Control 4 Handbook, 92441284-01
The Home screen indicates whether stimulation is ON or
OFF . If you have a rechargeable Stimulator, the Home Screen
will also display the current battery level of the Stimulator.
Icons at the top of the Home screen indicate the charge level
of the Remote Control battery , and the number of the
Program currently running.
Note
Pressing the Home button
from almost all other
screens will return you to
the Home Screen.
Home Screen
Stimulator
Battery Level
Rechargeable Stimulator
Program
Number
Remote
Control
Battery Level
Non‑Rechargeable Stimulator

Vercise™ DBS Remote Control 4 Handbook, 92441284-01
Page 10
This page intentionally left blank.

Quick Start Guide .........................................................12
Turn Stimulation ON/OFF ...............................................14
Recharging the Remote Control ....................................15
Accessories ...................................................................16
Using the Remote Control

Vercise™ DBS Remote Control 4 Handbook, 92441284-01
Page 12
Release
Side Button
to Unlock
3
12
Quick Start Guide
Unlock To turn Stimulation ON
press
To turn Stimulation OFF
press

Vercise™ DBS Remote Control 4 Handbook, 92441284-01
QUICK START
Page 13
To access the
Main Menu press
45
Lock

Vercise™ DBS Remote Control 4 Handbook, 92441284-01
Page 14
Stimulation can be turned ON and OFF by pressing the Stimulation
ON/OFF button . To turn stimulation ON or OFF, you must unlock
the Remote Control first; then, press the Stimulation ON/OFF button.
Note
Stimulation will not
automatically turn
OFF when the Remote
Control is locked
or when the screen
darkens to preserve
power in the Remote
Control battery.
To
START/STOP
stimulation,
press
Turn Stimulation ON/OFF

Vercise™ DBS Remote Control 4 Handbook, 92441284-01
QUICK START
Page 15
The Remote Control displays messages
reminding you to recharge the battery when
the battery power is low.
Charging
Remote
Recharging the Remote Control
Recharge the Remote Control battery
by connecting the Remote Control
to the USB Power Supply provided.
Connect the power plug end of the USB
Power Supply to a power outlet.
The Remote Control has a typical
battery service life of 400 charging
cycles.

Vercise™ DBS Remote Control 4 Handbook, 92441284-01
Page 16
The following accessories are provided with the Remote Control:
Silicone Case ‑ The Silicone Case
allows you to customize your
Remote Control. You can access all
the buttons, the USB port, and see
the screen while the device is in the
Silicone Case. The side buttons that
are covered by the Silicone Case are
still available for use.
Holster ‑ The Remote Control
holster allows you to carry the
Remote Control on a belt. You
can only access the Stimulation
ON/OFF button and the USB port
of the Remote Control while it is
enclosed in the holster.
Boston
Scientic
Accessories
CAUTION
Always place the
Remote Control in
the Silicone Case so
that the Stimulation
button is on the
open side of the
case and remains
uncovered.

Vercise™ DBS Remote Control 4 Handbook, 92441284-01
QUICK START
Page 17
USB Power Supply ‑ The USB Power Supply is used
to recharge the Remote Control battery. Connect the
USB connector on the Power Supply to the Remote
Control. Then, find a convenient electrical outlet that
will not expose the Remote Control or Power Supply
parts to water or direct heat. Connect the power
plug on the Power Supply to a power outlet. The USB
port on the Remote Control is designed to accept a
standard 5V Mini‑B USB power supply.

Vercise™ DBS Remote Control 4 Handbook, 92441284-01
Page 18
This page intentionally left blank.

What Is a Program? ......................................................20
Changing Stimulation Level ...........................................21
Accessing Programs ......................................................22
Overview of the Programs Menu ...................................23
Change to a Different Program .....................................24
Restore a Program ........................................................26
How To Use Programs

Page 20
Vercise™ DBS Remote Control 4 Handbook, 92441284-01
A Stimulation Program
P
is a group of configured settings that produce the stimulation to
help you manage your symptoms. One or more Programs were configured by your physician.
Whenever you are using your Stimulator, one of these Programs is active, and stimulation
is delivered according to the configured settings. The Remote Control can store up to four
Programs – numbered 1 through 4 – for you to select and activate at any time. Each Program is
identified by a number.
Each Program
P
may apply stimulation to as many as four stimulation areas. For example,
one area may correspond to a right brain target, while another area may correspond to a
left brain target. These stimulation areas control additional parameters that can affect your
stimulation therapy.
What Is a Program?