Medtronic DBS 37642 Patient Manual

USING YOUR

MEDTRONIC DBS
THERAPY SYSTEM

PATIENT GUIDE

Brief Statement: Results may vary from patient to patient. Not everyone who receives
Medtronic DBS therapy will experience the same results. Some people may experience

signicant symptom relief from DBS therapy, and others may experience minimal relief.

Talk to your doctor to see if Medtronic DBS therapy is right for you.

For further information, please consult your healthcare professional who can explain the
benets & risks and important safety information.

Medtronic International Trading Sarl
Route du Molliau 31
Case postale
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Switzerland
Tel: [phone]
Fax: [phone]

medtronic.eu

Medtronic United Kingdom
Building 9
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Watford, Herts
WD18 8WW
Tel: [phone]

medtronic.co.uk

UC201608429EE © 2017
Medtronic. All Rights Reserved.

USING THIS GUIDE

This guide provides basic information to help you use
your Medtronic deep brain stimulation (DBS) system.
It also describes other Medtronic resources available
to help you as you begin living with your implanted
DBS system.

Your Medtronic Patient Identication Card 3

Programmer Basics 5

Attaching the Antenna

Synchronizing Your Patient Programmer with Your
Neurostimulator 10

Therapy Screen Basics 11

Battery Check: Device and Programmer 19

Recharging System 23

Before Your MRI 28

Patient Resources 29

We’re Here to Help 30

For additional information, you may also refer to the

Patient Programmer 37642 Medtronic DBS Therapy user manual
and Recharger 37751 Charging System user manual.

You can nd step by step instructions at medtronic.com/
DBSProgrammerRecharger

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2

1

YOUR MEDTRONIC PATIENT IDENTIFICATION

Implanted Device Identication

For Medical Questions Contact Your Physician

UC200203837a ML© Medtronic, Inc. 2004

www.medtronic.com

Je suis porteur/euse d’un dispositif Médical implanté

risquant de déclencher votre système d’alarme.

Ich trage ein implantiertes medizinisches Gerät, das den

Alarm des Sicherheitssystems am Flughafen auslösen könnte.

Sono portaTOre/trice di un dispositivo medico impiantato che

potrebbe attivare il sistema d’allarme dell’aeroporto.

Tengo implantado un dispositivo médico que puede

activar la alarma del sistema de seguridad del aeropuerto.

I have an implanted medical device that
may set o your airport/security system.

DOE, JANE
1234 MAIN STREET
HOMETOWN, MN 56440

Stimulation System
Model #: Serial #: Implant date:
7426 NAXXXX2724H 01 Jan 1997

Emergency Physician(s):

Gabot Raez, M.D. Ralph Rashbauns, M.D.
[phone] [phone]

Medtronic Patient # [phone] 8am - 5pm CT

Implanted Device Identication

DOE, JANE
1234 MAIN STREET
HOMETOWN, MN 56440

Stimulation System
Model #: Serial #: Implant date:
7426 NAXXXX2724H 01 Jan 1997

Emergency Physician(s):

Gabot Raez, M.D. Ralph Rashbauns, M.D.
[phone] [phone]

Medtronic Patient # [phone] 8am - 5pm CT

CARD

Your Medtronic Patient Identication (ID) Card contains important information about

your medical device and includes your physician’s phone number in case you have a

medical question or emergency. Keep your ID card with you at all times, and ensure the

information on it is accurate.

Your ID card:

¡ identies you as having an implanted device in case of an emergency.
¡ includes a toll-free number to contact Medtronic.
¡ helps Medtronic maintain current and accurate information for

your records.

Your ID card allows you to notify security personnel and health professionals that you
have an implanted medical device. Present your ID card when you have any medical or

dental procedures, or when you must pass through a security screening system (such as
airport security) where your device may set o an alarm.

GETTING AN IDENTIFICATION CARD

You should have received a temporary ID card at the time of your implant procedure.

You will automatically receive a permanent plastic ID card from Medtronic, 3-4

weeks after the procedure. There is no fee for the card. Contact Patient Registration
at the number below if you do not receive a permanent ID card in 4-6 weeks.

We recommend that you carry your ID card with you at all times. If you move or

change physicians, or if any of the other information on the card changes, contact

Patient Registration to update your information and request a new card. You may
also update your card online at www.medtronic.com by selecting the Patients tab,
then clicking on Manage ID Card under the Tools heading.

If your ID card is lost or stolen, Patient Registration can issue a replacement card.

Patient Registration can also issue an extra card for a spouse.

Patient Registration Contact Information:

Call Medtronic DBS Helpline at [phone].
Monday – Friday, 9:00 to 16:00 GMT.

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4

PROGRAMMER BASICS

THERAPY ON/OFF KEY

A.

¡ Turns therapy ON or OFF.
¡ Programmer (antenna) must be placed directly over the neurostimulator while

pressing the THERAPY ON/OFF KEY.

Note: You must synchronize the neurostimulator and the programmer using the
CHECK KEY before turning therapy ON or OFF.

CHECK KEY

B.

¡ Synchronizes the neurostimulator and the programmer.
¡ Used to check the neurostimulator battery status.

POWER/BACKLIGHT ON/OFF KEY

C.

¡ Turns the patient programmer ON and OFF.
¡ Holding the key down turns the screen backlight ON or OFF.

SELECTION KEYS

D.

¡ Makes selections or changes based on the information displayed

on the screen.

NAVIGATOR KEYPAD

E.

¡ Allows you to scroll through menu options and is used to clear informational

messages on the screen.

¡ Press the up s and down t keys to move the box to the desired row.

¡ Press the left t and right s keys to see additional options in a

selected row.

D

A

B

C

For additional information, you may also refer to the Patient Programmer 37642
Medtronic DBS Therapy User and Recharger 37751 Charging System
user manual.

See Your Medtronic DBS Patient Therapy Guide for information on warnings, precautions,

risks, and benets.

5

E

Front View

6

INFORMATION AND WARNING SCREENS

Information Screens What to Do

Programmer is attempting to communicate with
the neurostimulator

¡ Place the programmer or the detachable antenna over

the neurostimulator.

Communication in progress

¡ Continue to place the programmer or the detachable

antenna over the neurostimulator.

Poor communication

¡ The programmer attempted to communicate

with the neurostimulator.
¡ Communication was unsuccessful.
¡ Reposition the programmer with the screen facing outward

or the antenna over the neurostimulator.
¡ If using the antenna, check that the antenna is connected

properly, reposition the antenna or remove and place the

patient programmer with the screen facing outward, and try

the communication again.

Note: If none of the above resolve the poor communication screen, contact

Medtronic DBS Helpline for further troubleshooting assistance.

(See number at end of book)

Programmer batteries are low and need
to be replaced

¡ Make sure you have extra AAA alkaline batteries available.

Warning Screens What to Do

Programmer batteries are depleted

¡ Programming is not possible.
¡ Replace the patient programmer batteries now.

Synchronize the programmer and neurostimulator

¡ Place the programmer or the antenna directly over the

neurostimulator and press the CHECK KEY .

EOS condition

¡ Neurostimulator battery is at End of Service.
¡ Therapy has stopped.
¡ Neurostimulator must be replaced to resume therapy.
¡ Call your physician immediately.

ERI (elective replacement indicator) condition

¡ The neurostimulator battery is close to its End of Service

date.
¡ Therapy will not be available soon.
¡ Call your physician immediately.
¡ Press any arrow on the NAVIGATOR KEYPAD to clear this

message.
¡ Once this screen is cleared, a ashing ERI icon will appear on

the Battery row of the Therapy screen.

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8

ATTACHING THE ANTENNA

SYNCHRONIZING YOUR PATIENT

Place the antenna directly over the neurostimulator.

A

Pull the fabric of your clothing through the large opening in the antenna. Then,

B

wedge the fabric in the narrow slit to secure the antenna in place.

PROGRAMMER WITH YOUR

NEUROSTIMULATOR

Place the programmer (with the screen facing outward) or antenna over the

A

neurostimulator and press the CHECK KEY .

Note: Using the CHECK KEY to synchronize also turns on the patient
programmer.

The Therapy screen appears displaying the neurostimulator battery status

B

dependent on the device you have.

Simple mode

Advanced mode* Activa RC Only

Push the antenna plug firmly into the antenna jack ( ) on the patient programmer.

C

Note: The antenna is optional. To use the programmer without the antenna, place
the programmer over the neurostimulator with the screen facing outward.

9

9

Battery status

Note: If you have two neurostimulators implanted, your patient programmer can
communicate with both neurostimulators, but only one at a time. The programmer

only displays information about the neurostimulator it is presently synchronized

with. The programmer must be turned o and then synchronized with the other

neurostimulator.

* You and your physician may have selected Advanced Mode based on your need to

adjust your therapy.

10

THERAPY SCREEN BASICS

ow

Group row

Group row

THERAPY SCREEN ICONS

There are two therapy modes available: Simple and Advanced. Your physician will decide
which mode you’ll receive and will discuss your therapy settings with you.

Simple mode

Status row

Battery r

If you have an Activa SC, the display would look like the below.

Advanced mode

left side

Advanced mode

right side

Status row
Battery row

Parameter/

Left Si de

Therapy

Right Side

Therapy

If you have an Activa PC or Activa RC that is delivering therapy to both sides of your

body, then the display would look like the below.

Row Icons Description

Status

Therapy is ON

Therapy is OFF*

Battery

Neurostimulator battery
status (nonrechargeable)

Parameter/Group**

Active group

Amplitude

Pulse width

Rate

Advanced mode Activa RC Only

Status row
Battery row

Parameter/

You may have the ability to change therapy settings when in Advanced Mode,
if prescribed by your physician.

The neurostimulator battery status is displayed on the Therapy screen.

11

* When the “text on” display format is activated, the word OFF will ash when the

neurostimulator is turned o. When the “text o/icon only” display format is
activated, the Warning icon (i.e., an exclamation mark in a triangle) will ash.

** The Parameter/Group row only appears in Advanced mode. If only one group is

available, this row displays only the parameter setting icon.

12

SELECTING A NEW GROUP

Only select the group that your physician has recommended for your specic needs.

The group feature is only available in the Advanced mode.

Hold the programmer (or antenna) over the neurostimulator (with the screen

A

facing outward) and press the CHECK KEY .

Press the down t arrow on the NAVIGATOR KEYPAD to move the selection

B

box to the Parameter row.

Press the up s or down t arrow on the NAVIGATOR KEYPAD to highlight the desired

D

group.

Hold the programmer (or antenna) directly over your neurostimulator

E

and press the CHECK KEY to synchronize with the programmer.

The Communication screen briey appears followed by the Therapy screen. The

Therapy screen will display your new therapy parameters and group setting.

Parameter/
Group row

Parameter row

Press the right sarrow on the NAVIGATOR KEYPAD to display the available groups.

C

The Group settings screen appears.

13

Communication

screen

14

14

Therapy screen with

new group setting

CHANGING THERAPY SETTINGS

The ability to change therapy settings is only available in Advanced mode.
You can only change the settings of the active group.

Hold the programmer (or antenna) over the neurostimulator (with the screen facing

A

outward) and press the CHECK KEY .

Press the desired selection key again to increase or decrease the selected therapy

D

setting as needed.

Indicates left
side of body

Press the down t arrow on the NAVIGATOR KEYPAD to move the selection box to

B

the Parameter row.

Press the Selection Key directly under the displayed setting you want

C

to adjust.

Setting for
the left side
of your body

Note: If you have an Activa PC or RC that is delivering therapy to both sides of your body,

the display will show both left and right values.

DBS

Setting for the
right side of
your body

Decrease
setting

Note: Access to increase or decrease the settings is determined by
your physician.

Press an arrow on the NAVIGATOR KEYPAD to return to the

E

Therapy screen.

Note: If you have multiple neurostimulators, the programmer must be turned o prior
to communicating with another neurostimulator. Repeat steps 1-5 for the other side of
your body if desired.

DBS

Increase
setting

15

16

RETURN TO PHYSICIAN SETTINGS

If you have changed your therapy settings and want to return to the settings selected by

your physician, follow these steps:

Hold the programmer (or antenna) over the neurostimulator (with the screen facing

A

outward) and press the CHECK KEY .

Press the down t arrow on the NAVIGATOR KEYPAD to move the selection box to

B

the Parameter row.

Parameter row

With the selection box highlighting the current group, press the right sarrow on the

D

Navigator key. The Group reset screen appears. Then press the CHECK KEY .
The programmer beeps when the group settings are changed (if the audio is turned
on).

Note: If the group you want to change back to physician settings is not active, you
must rst select that group to make a change.

Press the right sarrow on the NAVIGATOR KEYPAD to display the available groups.

C

The Group settings screen appears.

17

18

BATTERY CHECK:
DEVICE AND PROGRAMMER

CHECKING YOUR NEUROSTIMULATOR
BATTERY STATUS

You can check your neurostimulator by either placing your patient programmer over
your implant or by using the antenna.

Press the CHECK KEY . The Therapy screen appears.

Simple mode Advanced mode

Status Row

Battery Row

The second row on the Therapy screen is the Battery row. This row tells you the battery
status of your neurostimulator. The Battery row typically displays OK.

Simple mode

Advanced mode

Status Row

Neurostimulator battery charge level is depleted

¡ Therapy has stopped.
¡ Charge the neurostimulator battery immediately.
¡ Refer to the manual packaged with the charging system.

If the Battery row displays ERI (elective replacement indicator):

¡ The neurostimulator battery is close to its End of

Service date.
¡ Therapy will not be available soon.
¡ Call your physician.
¡ Press any arrow on the NAVIGATOR KEYPAD to clear this

message.

¡ Once the screen is cleared, a ashing ERI icon will appear on

the Battery row of the Therapy screen.

If you have a Activa RC, you have 1 year from ERI to EOS.
If you have a Activa PC/SC, you have approximately 3 months from

ERI to EOS with typical movement disorder settings.

Battery status

If you have an Activa RC Neurostimulator, the display will include the

battery charge level.
Neurostimulator battery charge level is low

¡ Therapy will not be available soon.
¡ Charge the neurostimulator battery immediately.
¡ Refer to the manual packaged with the charging system.
¡ Press any arrow on the NAVIGATOR KEYPAD to clear this message

from the screen.

19

If the Battery row displays EOS (end of service):

¡ The neurostimulator battery is at End of Service.
¡ Therapy has stopped.
¡ Neurostimulator must be replaced to resume therapy.
¡ Call your physician immediately.

Note: Your patient programmer has two display format options: “text on” and

“text o/icon only.” The programmer screens in this guide display the “text on”
format (i.e., the screens display icons and accompanying text). Please refer to the
Patient Programmer Model 37642 User Manual for more information about display

format options.

IMPORTANT: It is very important to check your neurostimulator
battery every day.

It is important for you to recharge your battery on a regular, frequent basis as
recommended by your doctor to make sure that the neurostimulator battery
remains charged.

20

CHECKING YOUR PATIENT PROGRAMMER
BATTERY STATUS

You can check your patient programmer battery by either placing your programmer over
your implant or by using the antenna.

Press the CHECK KEY . The Therapy screen appears.

Simple mode Advanced mode

Status Row

Status Row

To display the current programmer battery status:
Simple mode: Press the right s arrow on the NAVIGATOR KEYPAD twice to display the

programmer battery status.

Advanced mode: Press the up s arrow on the NAVIGATOR KEYPAD once to highlight

the Status row, then press the right s arrow.

Review the status of the programmer battery.

Replace
batteries

Full
charge

If the programmer batteries are depleted:

¡ Programming is not possible.
¡ Replace the programmer batteries now.

Note: The Battery Status screens for the neurostimulator and programmer

are displayed dierently.

Neurostimulator

Battery Status

Programmer

Battery Status

If the programmer batteries are low:

¡ You can nish programming.
¡ Press any arrow on the NAVIGATOR KEYPAD to clear the screen;

then continue programming.

¡ Replace the programmer batteries before the batteries become

depleted.

21

22

RECHARGING SYSTEM

If you have a rechargeable neurostimulator, this section explains how to recharge both

your neurostimulator and the recharger.
The Recharging System includes the following components:

The Recharger charges your implanted neurostimulator.

A

The Antenna establishes communication between the neurostimulator

B

and the recharger, when charging the neurostimulator.
The Belt can be used to keep the antenna positioned directly over the

C

neurostimulator during a charging session.
The AC Power Supply charges the recharger using AC power. Plug one

D

end into a wall outlet and the other end into the recharger.

Other charging options:

You may use an adhesive disc to hold the antenna in place (Ref .: 040618):
These double-sided adhesive discs provide better antenna coupling during

recharging, preventing the antenna head from moving unintentionally and

thereby improving the recharge time.
It is recommended not to place the adhesive directly on the skin.

(These buttons are not
used for DBS therapy.)

D

A

B

C

A

C

A belt may be available for abdominal placements.

23

B

D

Audio Control Key

¡ Turns the recharger on.
¡ When the recharger is

on, pressing the Audio
Control key again turns

the audible status

tones on and o.

24

Start Charge Key

¡ Begins charging the

neurostimulator.

Stop Charge Key

¡ Ends or interrupts

the neurostimulator
charging session.

CHARGING YOUR NEUROSTIMULATOR

To charge your neurostimulator:

Position the antenna. Press your skin where your neurostimulator is located to

A

determine the best place for the antenna. Depending on the location of your

implanted neurostimulator, you may use the belt or adhesive disc to ensure the

antenna is correctly positioned for charging.

Press the green Start Charge key on the recharger, after the antenna is

B

in place.

The Recharger Wait screen will display on the recharger, indicating that the

C

neurostimulator and recharger are trying to communicate with each other.

Note: If you want to check your signal strength after moving the antenna, press

the green Start Charge key to get immediate feedback.

Recharger Wait screen

When charging begins, the Neurostimulator Recharging screen will appear.

D

The bottom row of boxes on this screen will indicate the strength of the
charging signal.

C

B

A

D
E

Neurostimulator Recharging screen

A.A Neurostimulator is ON ( ) or OFF ( ).
B.Audio is ON or OFF
C. Status row — Displays information for the neurostimulator and

the recharger

D. Recharge Progress row — Indicates the progress of the recharging session.
E. Recharge Eciency row — Indicates the eciency of the recharging signal

between the neurostimulator and the recharger (more black boxes mean

better eciency and shorter recharge duration).

If all eight boxes are solid black, the charging signal is as strong as possible, and the

charging session will be as short as possible.

Note: These black boxes are only an indicator of the charging signal strength
and do not indicate how much the battery has been charged.

Adjust signal strength. Signal strength can be improved by ensuring that the

E

antenna is not placed over bulky clothing. You can also increase the charging signal

strength by either adjusting the dial or repositioning the antenna. To adjust the dial,

turn it a quarter turn in either direction. Then press the Start Charge key again.

When recharging begins, you will see the Neurostimulator Recharging screen.

F

This screen is used to:

- Check the status and progress of the neurostimulator recharging session.

- Show you the battery status of your recharger.

- Display a ashing battery icon for the neurostimulator, indicating that the battery
is recharging.

Charging progress

Neurostimulator Recharging screen

Note: The recharge eciency (number of boxes lled) is dependent on the position

of the antenna and the location and depth of your implant. In some cases, you may
reach your maximum eciency with less than eight black boxes lled. Use the dial
on the antenna to improve eciency.

When your neurostimulator battery is almost full, the Neurostimulator Charge

G

Sucient screen will appear. It is ok to stop charging at this point.

Charge Sucient screen

25

25

26

Neurostimulator charging tips:

¡ Turning stim on/o with the recharger for DBS is disabled.
¡ If the recharger loses its connection to your neurostimulator, you may hear three

beeps and the Reposition Antenna screen will appear.

Reposition Antenna screen

To reestablish the connection, reposition the antenna over your neurostimulator and

press the green Start Charge key again.

¡ If you need to interrupt your charging session, press the Stop Charge key on the

recharger. To resume the charging session, press the Start Charge key again.

BEFORE YOUR MRI

Depending on the type of DBS system you have, you may be eligible for either a full-

body or head-only MRI scan. You can help your physician and radiologist determine
which type of scan you are eligible for by following these guidelines.

Tell the physician who prescribed your MRI scan that you have an implanted

A

Medtronic DBS system. An MRI scan could be prescribed by a variety of physicians,

including a general practitioner, orthopedist, oncologist, or a pain specialist.

Contact the physician who manages your DBS to discuss your upcoming MRI

B

scan. Your neurologist should tell you if you can safely undergo the type of MRI scan

prescribed.
Your neurologist may also provide you or your radiologist with a copy of the MRI

Patient Eligibility Form. The information on this form can help the radiologist

conrm your eligibility for the prescribed MRI scan.

When your MRI appointment is scheduled. You will want to work with the physician

C

who manages your DBS therapy to prepare for your scan. Make sure your bring your
programmer and patient ID card with you the day of the scan.

CHARGING THE RECHARGER

Plug the AC power supply cord into an AC outlet. A green light on the power supply

A

indicates it has power.

Connect the AC power supply. The recharger will automatically start to charge

B

when connected to the AC power supply, and the recharger charging session will
be displayed.

Recharger battery status

Audio is ON or OFF

Recharger battery
charge level

Indicates that your
recharger is plugged
into AC power

Status row

Recharge progress row

If you have questions about your MRI Scan eligibility or how to prepare

your DBS system for an MRI scan, contact your physician who manages
your DBS therapy or Medtronic DBS Helpline at [phone].

Instructional videos explaining how to charge your implanted
neurostimulator and your recharger may be viewed at the following
website: medtronic.com/recharging

27

28

WE ARE HERE TO HELP

The following resources are available to assist you with your implanted
DBS system.

Call Medtronic DBS Helpline at [phone]
Monday – Friday, 9:00 to 16:00 for assistance with:

¡ Programmer or recharger troubleshooting.

¡ Information around living with your DBS system.

¡ Your Medtronic Patient ID card.

Follow up with your doctor for assistance with:

¡ Medical concerns.

¡ Management of your therapy, including what stimulation level you

should use and adjustments to stimulation level, if needed.

Help with your Medtronic DBS patient programmer or
recharging system

¡ Your physician, nurse, or Medtronic representative may show you

how to use your programmer or recharger. Call the clinic if you
need more help or have questions.

¡ You will receive a manual with detailed instructions.

¡ Medtronic DBS Helpline can send you another copy of your manual

or answer questions about how to use your programmer.

29

30

NOTES

31