Boston Scientific VERCISE DBS User manual

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Trademarks
All trademarks are the property of their respective holders.
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.
Additional Information
Refer to the appropriate Information for Patients DFU and Remote Control Handbook for additional instructions and information
about your DBS System. Refer to the Labeling Symbols document for an explanation of labeling symbols.
References to the Charging System or charging process are applicable only when using a rechargeable DBS Stimulator.
Contacting Boston Scientic
To contact Boston Scientic, see the “Technical Support” section of this manual.
Product Model Numbers
Model Number Product Name
DB-64126 Vercise Charging Belt System
DB-6358-0BK Vercise Charging Belt, Small
DB-6358-1BK Vercise Charging Belt, Medium
DB-6358-5BK Vercise Charging Belt Extension
DB-6358-9BK Vercise Charging Belt Loop Replacement
NM-6350 Adhesive Kit
NM-5312 Charger
NM-5305 Base Station
NM-6305 Power Supply & Adapter For Charger (EU)

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Table of Contents
Introduction.........................................................................................................................................................1
Using the Charging System...............................................................................................................................2
Getting Set Up...........................................................................................................................................4
Charging the Charger................................................................................................................................5
Understanding the Charger Sound Alerts .................................................................................................7
Charging Your Stimulator ..........................................................................................................................8
Using the Charging Belt ............................................................................................................................9
Using the Adhesive Patch .......................................................................................................................14
Properly Aligning the Charger .................................................................................................................15
Tips for Properly Aligning the Charger ....................................................................................................17
Cleaning Instructions...............................................................................................................................19
Technical Support ............................................................................................................................................20

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Introduction
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Introduction
The Boston Scientic Deep Brain Stimulation (DBS) System provides a reversible therapy that stimulates structures in
the brain with small electrical pulses. The Boston Scientic DBS System includes a rechargeable Stimulator that requires
periodic recharging. The Charging System allows you to recharge the Stimulator as needed.
The Charging System for the Stimulator consists of the Charger, a Base Station, and a Power Supply. The Charging
System also includes a Charging Belt that holds the Charger over the Stimulator.
This manual provides you with instructions for charging your Stimulator. We encourage you to read this and your other
Boston Scientic manuals entirely. If you have any questions, or need clarication on anything contained in this manual,
contact Technical Support.

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Using the Charging System
You should expect a daily recharging time of 5 to 30 minutes per day or a periodic recharging time of
30 minutes to 4 hours every 1 to 2 weeks. Your recharge routine may vary depending on your stimulation settings. Some
stimulation settings will require more frequent charging. Boston Scientic recommends any recharge routine that ts your
schedule and lifestyle while maintaining sufcient charge to maintain stimulation.
Developing a recharge routine involves nding the right balance between four factors:
●How much power is required to experience effective therapy
●How often you want to recharge
●How long you want to recharge
●How you would like to manage your personal schedule
The Boston Scientic DBS System’s programming software gives your healthcare provider a conservative
recommendation for how often to charge. This estimate assumes stimulation is on 24 hours per day, 7 days per week at
the programmed energy output level. While you may want to follow these recommendations, you and your physician can
also develop an appropriate charge routine that best ts your schedule.
The Remote Control provides an easy‑to‑view Stimulator battery meter on the Home screen and messages to inform
you of the battery’s condition. When the Remote Control indicates a low battery, the Stimulator should be recharged as
soon as possible. Failure to recharge may result in loss of stimulation. After stimulation stops, communication with the
Stimulator will also stop until the Stimulator is sufciently charged. Refer to your Remote Control Handbook for more
information.

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The rechargeable Stimulator battery should provide at least ve years of service. In many cases, the Stimulator battery
should provide at least 25 years of service. Battery life is dependent on the stimulation settings and conditions.
Over time and with repeated charging, the battery in the Stimulator will lose its ability to recover its full capacity. As
a result, the Stimulator may require shorter intervals between charges. The Stimulator will need replacement when
stimulation can no longer be maintained with a routine charging.

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Getting Set Up
Check that you have received all the components included in your DB‑64126 Vercise Charging Belt System (see Table 1).
If any item is missing, contact Technical Support for a replacement.
Table 1: Components of the Vercise Charging Belt System
Label Description
ACharging Belt (1)
BBase Station (1)
CCharger (1)
DPower Supply (1) and Adapter (1)
A
B DC

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Charging the Charger
The Charger contains a rechargeable battery that is used to recharge your Stimulator’s battery (see Table 2).
Cautions:
●Keep the Charging System dry. It should not be
exposed to moisture.
●Do not connect the Charger to any other device except
to the Base Station provided with it.
●Keep the Charging System away from pets, pests, and
children to avoid damage to the device.
To charge the Charger:
1. Find a convenient electrical outlet that will allow you to place
the Base Station on a clear, at surface and will not expose
the Charging System to water or direct heat.
2. Plug the Power Supply into a standard AC wall outlet.
3. Connect the Power Supply to the Base Station.
4. Place the Charger in the Base Station with the power button
facing up.
Note: The Base Station is designed to remain connected to a power outlet at all times. When it is not being used, keep
the Charger on the Base Station so that it is always ready to deliver a charge.
Table 2: Vercise Charger System Components
Label Description
APower Supply
B Charger
C Indicator Light
DPower Button
E Base Station

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The Charger is ready to fully charge your Stimulator when the Charger’s indicator light is green. If the indicator light is
yellow, the Charger can only partially charge the Stimulator. While the Charger may be used when the indicator light is
yellow, it may not be able to fully charge your Stimulator and you may need to charge sooner than usual.
Charger
Indicator Light Description
Green The Charger is fully charged and ready to charge the Stimulator.
Yellow The Charger is partially charged. The Charger may still be used, but it may not be able to
fully charge the Stimulator. To fully charge the Charger, place it in the Base Station.
Off The Charger is off – or – the Charger battery is empty. If pressing the Power Button does
not turn on the Charger, place the Charger in the Base Station to charge.
Charger Battery Service Life
The Charger battery has a typical service life of 500 charging cycles.

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Understanding the Charger Sound Alerts
The Charger emits different sounds to alert you of specic situations. Before you begin charging your Stimulator, it is
important to understand these sounds. The following chart describes what each sound means.
Sound Description
Repeated Single
Beep
The Charger is searching for your
Stimulator and is not properly aligned
with the Stimulator. Align the Charger
as shown in the “Properly Aligning the
Charger” section of this manual.
Repeated Double
Beep
The Charger has fully charged the
Stimulator battery. Turn off the Charger
and return it to the Base Station.

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Charging Your Stimulator
When charging, you must use the Charger with either the Charging Belt or an Adhesive Patch to hold the Charger over the
Stimulator. The Adhesive Patches are made of non‑reactive and natural Latex‑free material suitable for most sensitive skin
types.
WARNINGS:
●Do not charge while sleeping. This may result in a burn.
●While charging, the Charger may become warm. It should be handled with care.
●Failure to use either the Charging Belt or an Adhesive Patch while charging may result in a burn. If pain or
discomfort is felt, stop charging and contact your health care provider.

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Using the Charging Belt
There are two lengths of the Charging Belt available (Small and Medium). If you need to order a Charging Belt Extension,
a different size Charging Belt, a Charger Spacer, or a replacement Belt Loop, contact Technical Support.
Note: A Charging Belt Extension is available if the Charging Belt is too small. If using the extension, insert one strap
through the loop on the extension and fasten the strap onto the belt (Figure 2).
1. When the indicator light is green, remove the Charger from the Base Station.
Note: Once the Charger is removed from the Base Station, the Charger indicator light will turn off regardless of the
ready status of the Charger.

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2. Place the Charger in the pouch of the Charging Belt so that the power button is visible through the mesh fabric
(Figure 1).
Figure 1. Placing the Charger in the Pouch
3. Close the pouch.
4. Place the Charging Belt around your body so that the power button and mesh fabric are facing out (Figure 1).

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5. To set the length of the Charging Belt, place the Charging Belt around your body and insert each strap through the Belt
Loop. Afx the straps using fasteners. Each strap is adjustable. See Figure 2 and Table 3 for reference.
Table 3: Charging Belt Key Features
Label Description
1Pouch for Charger
2Adjustable Straps
3Hook‑and‑Loop Fasteners
4 Belt Loop
Note: In this image, the right strap is afxed and the left strap is not afxed.

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Afx the adjustable straps so that the Belt is slightly loose at rst. In order to properly use the Charging Belt, both of the
straps must go through the Belt Loop (Figure 2).
Figure 2. Adjustable Strap Placed Through Belt Loop and Afxed Using Fasteners
6. Position the Charger over the Stimulator.
When the Charger is aligned over the Stimulator, the beeping will stop. For the best charging results, make sure the
Charger is well ventilated and centered over the Stimulator (Figure 3). See the “Properly Aligning the Charger” and
“Tips for Properly Aligning the Charger” sections of this manual to ensure you center the Charger over the Stimulator.
Figure 3. Ideal Alignment of Charger (Outlined) Over Stimulator (Dotted Line)

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7. Secure the Charger over the Stimulator by securing the Charging Belt.
Be careful to maintain the Charger’s alignment as you tighten the Belt. Take care not to overtighten the Belt, which may
result in discomfort or accidental movement of the Charger.
Note: Wearing the Charging Belt over loose tting clothes may result in more frequent movement of the Charger.
For the best results, occasionally check the Charger to make sure that it is centered over the Stimulator. If the
Charger is not centered over the Stimulator, charging time may increase. If the Charger signicantly moves out
of alignment, it will start beeping again (Figure 4).
Note: The Charging Belt can be placed under or over clothing. You should not wear tight tting or heavy clothing over
the Charger while charging to allow air ow around the Charger.
Note: Do not use the Charging Belt when it is wet or damp.
Figure 4. Poor Alignment of Charger (Outlined in Grey) Over the Stimulator (Dotted Line)

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Using the Adhesive Patch
1. When the indicator light is green, remove the
Charger from the Base Station.
Note: Once the Charger is removed from the
Base Station, the Charger indicator light
will turn off regardless of the ready status
of the Charger.
2. Apply the Adhesive Patch to the backside of the
Charger by peeling the clear liner from the patch
and applying the white side with the blue stripe to
the rear of the Charger (Figure 5).
3. Remove the skin side beige liner from the adhesive (only good for one xation).
4. For best charging results, make sure the Charger is centered over the Stimulator. If the Charger is not centered,
charging time may increase. See the “Properly Aligning the Charger” and “Tips for Properly Aligning the Charger”
sections of this manual to ensure you center the Charger over the Stimulator. It is recommended that you follow the
instructions in both sections the rst time you charge your Stimulator.
Note: Do not put the Charger directly on the skin (e.g., without an Adhesive Patch).
Figure 5. Peel the Clear Liner from the Adhesive Patch

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Properly Aligning the Charger
1. Press the power button. The indicator light will
come on again, and the Charger will begin
beeping repeatedly to signal that it is searching
for the Stimulator.
2. Position the Charger over the Stimulator
(Figure 6).
The beeping will stop when the Charger is
partially aligned with the Stimulator. For optimal
charging, make sure the Charger is centered
over the Stimulator.
Charging time may increase if the Charger is not fully aligned with the Stimulator. To fully align the Charger over the
Stimulator, position the bottom curve of the Charger approximately 1 cm lower than the bottom curve of the Stimulator.
If you are having trouble properly aligning the Charger or experiencing longer than normal charging times, see the
“Tips for Properly Aligning the Charger” section of this manual.
Figure 6. Position the Charger Over the Stimulator

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3. Secure the Charger over the Stimulator by aligning the Charging Belt, or by pressing the adhesive to the skin over the
Stimulator.
Note: If the Charging Belt moves out of alignment, or if the Adhesive Patch is accidentally located in the wrong place,
the Charger will start beeping again. Realign the Charging Belt, or use a new Adhesive Patch to place the
Charger back into the fully aligned position.
Note: Moving around while charging is acceptable, but be aware that the Charger must stay centered over the
Stimulator for proper charging. Excessive movement may cause the Charger and Stimulator to become
misaligned.
4. When the Charger emits a distinct double beep, press the power button to turn off the Charger and check the
Stimulator’s battery with the Remote Control.
5. If the Stimulator is fully charged, remove the Charging Belt or Adhesive Patch from your body.
Note: Do not confuse the end of charge signal (a distinct double beep) with repeated beeping indicating
misalignment.
6. Separate the Charger from the Charging Belt or Adhesive Patch.
Set aside the Charging Belt or discard the Adhesive Patch.
7. Return the Charger to the Base Station.