Medtronic 97725 Technical Manual

Wireless External Neurostimulator

97725

User manual

  Rx only

Explanation of symbols on product or package labeling

Refer to the appropriate product for symbols that apply.

Consult instructions for use

Use by

Sterilized using ethylene oxide

-XX °C

-XX °F

EO

Do not reuse

Do not resterilize

2

STERILIZE

Do not use if package is damaged

Manufacturer

Date of manufacture

XX °C

Temperature limitation

XXX °F

Serial number

STERILE

PIN No.

MR

PIN number

Magnetic Resonance (MR) Unsafe

IEC60601-1/EN60601-1, Type BF equipment

Keep dry

 2017-06-01  English 3

For USA audiences only

Authorized Representative in the European Community

REP

EC

Conformité Européenne (European Conformity). This symbol means
that the device fully complies with MDD 93/42/EEC (NB 0123).

Do not dispose of this product in the unsorted municipal waste stream.
Dispose of this product according to local regulations. See http://
recycling.medtronic.com for instructions on proper disposal of this
product.

Chinese Standard (SJ/T11364-2006) Logo: Electronic Information
Products Pollution Control Symbol. (The "e" in this logo signifies none
of the restricted substances are present above permitted levels.)

The Technical Conformity mark signifies that this device complies with
Japan Radio Law.

The KCC Certification mark signifies that this device complies with
South Korea's radio requirements for telecommunication equipment.

The RCM Certification mark signifies that this device complies with
Australia/New Zealand EMC requirements for electrical and electronic
equipment.

4 English  2017-06-01

Medtronic® and SoftStart/Stop® are trademarks of Medtronic, Inc., registered in the U.S.
and other countries.

The BLUETOOTH
SIG, Inc., and any use of such marks by Medtronic is under license.

®

word mark and logos are registered trademarks owned by Bluetooth

 2017-06-01  English 5

6 English  2017-06-01

Table of contents

Purpose of the device 9

Description 9

Package contents 9

Accessories 9

Device specifications 9

Declaration of Conformity 13

Instructions for use 14

Pairing the wireless external neurostimulator to a programmer or controller 14
Using the wireless external neurostimulator during intraoperative testing 14
Wireless external neurostimulator batteries 15

Changing the wireless external neurostimulator batteries 16
Connecting leads to the wireless external neurostimulator 18
Inserting 4-contact lead(s) into the wireless external neurostimulator 18
Inserting 8-contact lead(s) into the wireless external neurostimulator 20
Preparing the wireless external neurostimulator for trial stimulation 21
Removing the wireless external neurostimulator after trial stimulation 22

Device care and storage 22

Safety and technical checks 23

Refer to the indications sheet for indications and related information.

Refer to the appropriate information for prescribers booklet for contraindications,
warnings, precautions, adverse events summary, individualization of treatment,
patient selection, use in specific populations, resterilization, and component
disposal.

Refer to System Eligibility, Battery Longevity, Specifications reference manual for
neurostimulator selection, battery longevity calculations and specific
neurostimulator specifications.

! USA

Refer to the clinical summary booklet for information on the clinical study

results of the neurostimulation system and individualization of treatment.

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Purpose of the device

The Medtronic Model 97725 Wireless External Neurostimulator (ENS) is part of a
neurostimulation system used for intraoperative testing during lead placement and for trial
stimulation outside of the operating room.

Description

The Medtronic Model 97725 Wireless External Neurostimulator is a disposable, sterile,
single-use device equipped with BLUETOOTH

®

wireless technology.

Package contents

Wireless external neurostimulator with batteries inserted

▪

Spare nonsterile AAA alkaline batteries (2)

▪

Product literature

▪

! USA

Warranty card

▪

Accessories

Model 375003 External Neurostimulator Boot (nonsterile accessory kit – packaged

▪

separately)

Device specifications

The Model 97725 Wireless External Neurostimulator (Figure 1 and Figure 2) is a multi­programmable device that delivers stimulation through one or more lead-extension(s),
depending on the system configuration. The stimulation settings are stored in programs to
target specific effects or areas. A program is a specific combination of pulse width, rate, and
intensity settings acting on a specific electrode combination (up to 16 electrodes per
program). Up to four programs can be included in a group, and there can be up to three
groups of programs. When a group contains more than one program, the pulses are
delivered sequentially—first a pulse from one program, then a pulse from the next program.

Pulse width, rate, intensity, cycling, and electrode polarity for each program within a group
can have different values. Rate limits, pulse width limits, and intensity limits for each
program within a group have the same values.

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ENS button

Lead door seams

Lead housing
compartment,
black (electrodes 8-15)

Lift tabs

Lead housing
compartment,
white (electrodes 0-7)

Figure 1. Model 97725 Wireless External Neurostimulator (doors closed).

LED light

8 - contact
lead groove

Electrical
contacts

4 - contact
lead groove

Retainer clip

Figure 2. Model 97725 Wireless External Neurostimulator (doors open).

Table 1. Operating values for the Model 97725 Wireless External Neurostimulator

Programmable parameter

Operating values and ranges

a

Number of defined groups 1 – 3
Number of programs 12
Number of programs per

group

1 – 4

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Table 1. Operating values for the Model 97725 Wireless External Neurostimulator

Programmable parameter

Operating values and ranges

(continued)

a

Electrode configuration 2 – 16 electrodes as anode (+), cathode (-), or Off
Maximum intensity per

electrode

0 – 25.5 mA (0.1 mA increment)

Program intensity 0 – 100 mA
Intensity – limits Enabled or disabled at maximum 25.5 mA per electrode
Pulse width 60 – 1000 µs (10-µs increment)
Pulse width – limits Enabled or disabled at maximum 1000 µs

Rate

b

40 – 1200 Hz (increment: 5 Hz from 40 – 250 Hz, 10 Hz from
250 – 500 Hz, 20 Hz from 500 – 1000 Hz, 50 Hz from
1000 – 1200 Hz)

Rate ratio A fraction of the rate (1/1, 1/2, 1/3, 1/4, 1/5, 1/6, 1/7, 1/8, 1/9,

Rate - limits

1/10, 1/11, 1/12, 1/13, 1/14, 1/15, 1/16, 1/17, 1/18, 1/19, 1/20)

Enabled or disabled (at maximum of 1200 Hz)

b

SoftStart/Stop Off, On: 1, 2, 4, or 8 second ramp duration
Cycling Off: 0.1 s – 30 min (increment: 0.1 s from 0.1 – 1 s, 1 s from

1 s – 1 min, 1 min from 1 – 30 min)
On: 5 s – 30 min (increment: 1 s from 5 s – 1 min, 1 min from

1 – 30 min)

a

Interlocks will prevent the use of some parameter combinations.

b

Rate availability depends on how many programs are defined. For example, the maximum rate available
in one defined program is 1200 Hz. The maximum rate available if two programs are defined is 600 Hz in
each of those two programs.

Table 2. Physical characteristics of the Model 97725 Wireless External

Neurostimulator

a

Description Value

Capacity

Leads 4 quadripolar; 2 octapolar
Electrodes 32 electrodes, supporting 16 active

Length 79 mm (3.1 in)

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Table 2. Physical characteristics of the Model 97725 Wireless External

Neurostimulator

a

(continued)

Description Value

Width 74 mm (2.9 in)
Thickness 20 mm (0.8 in)
Weight (with batteries) 71 g (2.5 oz)
Battery life

External neurostimulator
service life

7 days minimum for alkaline batteries

c

90 days

b

Power source AAA alkaline batteries (2)
Operating type Continuous
Degree of protection against

electrical shock

Automatic shut off

d

Type BF

Lead door(s) open

Operating temperature 9 °C to 40 °C (49 °F to 104 °F)

e

Temperature limitation

-20 °C to 54 °C (-4 °F to 129 °F)

Identification code NLJ

a

All measurements are approximate.

b

Battery life is based on a 7-day trial using two active programs, 20 90-second daily controller
BLUETOOTH sessions, and a 180-minute clinician programmer BLUETOOTH session. For program 1:
impedance = 620 Ω, Amp = 10.6 mA, PW = 330 µs, Rate = 60 Hz. For program 2: impedance = 560 Ω,
Amp = 10.5 mA, PW = 330 µs, Rate = 60 Hz.

c

Service life is based on 24-hour stimulation.

d

Use the clinician programmer or controller to turn stimulation on once the condition is resolved.

e

Store the external neurostimulator at room temperature.

Table 3. Material of components in the Model 97725 Wireless External Neurostimulator

and boot accessory packages

Component Material Material contacts

human tissue

Housing

Base Polycarbonate Yes
Lead doors Polycarbonate Yes
Hinge pin Stainless steel No

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Table 3. Material of components in the Model 97725 Wireless External Neurostimulator

Component Material Material contacts

Contacts Gold- and nickel-plated beryllium copper No
Retainer clip Thermoplastic elastomer (TPE) Yes

External neurostimulator
boot (optional)

Boot Silicone Yes
Adhesive Medical acrylic microporous-coated

and boot accessory packages

adhesive

(continued)

human tissue

Yes

Declaration of Conformity

Medtronic declares that this product is in conformity with the essential requirements of
Directive 93/42/EEC on Medical Devices.

For additional information, contact the appropriate Medtronic representative listed on the
inside back cover of this manual.

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Instructions for use

The wireless external neurostimulator can be used for intraoperative testing during lead
placement and for trial stimulation outside of the operating room.

Warning:

reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may
compromise the structural integrity of the device and/or create a risk of contamination
of the device, which could result in patient injury, illness, or death.

Warning

or who have any neurostimulation system components that are not fully implanted.
Explant all trial stimulation components if an MRI scan is required. MRI has not been
tested on trial stimulation components and may cause heating of the lead electrodes,
resulting in tissue damage or serious patient injury.

Caution:

mixture with air or with oxygen or nitrous oxide. The consequences of using the device
near flammable atmospheres are unknown.

Caution:

damage to the device, causing the device to malfunction or become unusable.

Caution:

communication. If EMI interference is suspected, move away from the likely source of
EMI and try again.

Notes:

Before placing the external neurostimulator into operation, ensure the external

▪

neurostimulator has had time to equalize to the current temperature and environment.
For more information on EMI and x-ray use with the external neurostimulator, refer to

▪

the
Turn stimulation off and dispose of the external neurostimulator after defibrillation. For

▪

more information on the effects of defibrillation on the neurostimulator, refer to the

Information for Prescribers Booklet

Pairing the wireless external neurostimulator to a programmer or controller

For instructions on pairing the external neurostimulator to the clinician programmer or the
controller, refer to the appropriate clinician programming guide.

Using the wireless external neurostimulator during intraoperative testing

When programming during intraoperative testing, keep the clinician programmer within 3
meters (10 feet) of the external neurostimulator. The external neurostimulator is sterile and
does not attach to the programmer. Do not use the external neurostimulator if the storage

This device was designed for single patient use only. Do not reuse,

: Physicians should not prescribe MRI for patients undergoing trial stimulation

The device is not certified for use in the presence of a flammable anesthetic

Do not modify this equipment. Modification of this equipment can result in

Electromagnetic interference (EMI) can disrupt programming and telemetry

Information for Prescribers Booklet

.

.

14 English  2017-06-01

package has been pierced or altered because component sterility cannot be guaranteed. If
external neurostimulator sterility is compromised during intraoperative testing, do not use
the external neurostimulator.

Using the ENS button

The

ENS

button is used to put the external neurostimulator into discovery mode to establish
communication with a clinician programmer or controller. It can also be used when you
need to immediately turn stimulation off. You must use either the clinician programmer or
controller to turn stimulation on.

Press and hold the

▪

Understanding the LED light on the wireless external neurostimulator

When you press and hold the
shines continuously for a few seconds. When the LED begins to flash, the external
neurostimulator has completed initiation, has entered discovery mode, and can be paired to
a clinician programmer or controller.

Notes:

The external neurostimulator will remain in discovery mode for 90 seconds, or until it

▪

successfully pairs with a clinician programmer or controller, at which point the LED
will stop flashing and turn off.

The LED flashes at a constant rate whenever the external neurostimulator is in

▪

discovery mode.
The LED will flash whenever the external neurostimulator receives data from a

▪

clinician programmer or controller.
Refer to the appropriate clinician programming guide or controller patient manual for

▪

more information.

ENS

button for at least 3 seconds to turn stimulation off.

ENS

button for one second, the light-emitting diode (LED)

Wireless external neurostimulator batteries

Two AAA alkaline batteries are preinserted in the sterile external neurostimulator and
should last the length of the trial stimulation period (see Table 2 for more information on
battery longevity). Replace the external neurostimulator batteries when the batteries are low
or depleted. The battery level is shown on the clinician programmer and controller screens.
For instructions on checking the external neurostimulator batteries, refer to the appropriate
clinician programming guide.

Patient use and stim usage data are automatically saved to the external neurostimulator at
the beginning of each hour. However, if the external neurostimulator batteries are replaced
before the data is saved, the patient use and stim usage data for the previous hour may be
lost. Prior to replacing the batteries, start a session with the clinician programmer. This
allows the clinician programmer app to retrieve the data from the external neurostimulator.

Caution:

Do not leave depleted batteries in the external neurostimulator. The

batteries may corrode and cause damage to the electronic components.

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Changing the wireless external neurostimulator batteries

Note:

Two spare, nonsterile AAA alkaline batteries are provided in the external
neurostimulator package. Always replace the external neurostimulator batteries
outside of the sterile field.

1.

If stimulation is on, use the clinician programmer or controller to turn stimulation off.

2.

If the batteries are being changed while the patient is undergoing trial stimulation:
a. Remove the tape from the external neurostimulator, and if applicable, the external

neurostimulator from the boot, keeping lead(s) and lead exit site secure. For
instructions on removing the external neurostimulator from the boot, refer to the

external neurostimulator boot instructions for use.
b. Lift the lift tabs to open the lead doors.
c. Note the location of each of the lead(s) in the external neurostimulator to ensure

identical seating of the lead(s) inside the lead grooves after the batteries are

changed.
d. Gently lift each lead from the electrical contacts in the lead groove.

Note:

Remove the leads from the external neurostimulator prior to replacing the

batteries in order to avoid lead kinking or dislodgement.

3.

Press back lightly on the latch of battery compartment cover, swing the cover open,
then remove the cover (Figure 3).

Figure 3. Removing battery cover.

Note:

Before replacing batteries, check for signs of battery leakage. If any residue is

present, do not use the external neurostimulator.

4.

Remove the depleted batteries, and insert new, Medtronic-supplied AAA alkaline
batteries. Correct battery polarity is indicated inside the battery compartment
(Figure 4).

Note:

For optimal performance, use the same AAA alkaline batteries as those

supplied by Medtronic.

16 English  2017-06-01

Figure 4. Inserting new batteries.

5.

Replace the battery compartment cover, then press the cover until it snaps into place
(Figure 5).

Figure 5. Replace battery cover.

Notes:

After the batteries are installed and the battery compartment cover is closed, the

▪

external neurostimulator may take up to 6 seconds for device initiation.
Stimulation is not available until device initiation is complete.

Dispose of depleted batteries according to local requirements.

▪

6.

Insert the lead(s) into the external neurostimulator. Refer to "Inserting 4-contact
lead(s) into the wireless external neurostimulator" on page 18 or "Inserting 8-contact
lead(s) into the wireless external neurostimulator" on page 20 for instructions on
inserting the lead(s) into the external neurostimulator.

Note:

If replacing batteries during trial stimulation, ensure identical seating of the

lead(s) inside the lead grooves.

7.

Use either the clinician programmer or controller to turn stimulation on.

8.

Use the clinician programmer to perform the check connectivity task and confirm that
the lead(s) have been fully inserted into the correct lead grooves. For instructions on
the check connectivity task, refer to the clinician programming guide.

 2017-06-01  English 17

9.

Secure the external neurostimulator to the patient. Refer to "Preparing the wireless
external neurostimulator for trial stimulation" on page 21 for instructions on securing
the external neurostimulator to the patient.

Connecting leads to the wireless external neurostimulator

The external neurostimulator has two lead housing compartments that each fit two 4-contact
leads and one 8-contact lead. The leads are inserted in lead grooves, which are numbered
0-7 on the white side and 8-15 on the black side (Figure 1). Leads are inserted in both of the
lead housing compartments.

If using four 4-contact leads, two are inserted in each housing compartment.

▪

If using two 8-contact leads, one is inserted in each housing compartment.

▪

If using two 4-contact leads and one 8-contact lead, the 4-contact leads are inserted in

▪

one housing compartment and the 8-contact lead must be inserted in the other.

Notes:

The 4-contact leads and the 8-contact leads are inserted into the external

▪

neurostimulator in the same direction.
The lead procedures apply to leads and extensions.

▪

Inserting 4-contact lead(s) into the wireless external neurostimulator

Check battery status before inserting the lead(s) into the external neurostimulator. Refer to
the clinician programming guide for information on checking battery status.

Caution:

Before connecting components, wipe off any body fluids and dry all
connections. Fluids in the connection may result in intermittent stimulation or loss of
stimulation.

1.

Wipe the lead contacts with dry sterile gauze.

2.

Lift the lift tab on the appropriate lead housing compartment to open the clear lead
door (Figure 6a).

3.

Disconnect the long stylet handle from the 4-contact lead and withdraw the long stylet
from the 4-contact lead.

4.

Insert the short stylet into the 4-contact lead and connect the short stylet handle to the
4-contact lead.

5.

Make sure the lead contacts and the electrical contacts inside the lead grooves are dry
and clean.

6.

Align the short stylet and proximal end of the lead against the inside end of a 4-contact
lead groove of the connector (Figure 6a).

18 English  2017-06-01

Short stylet handle

ab

Lead groove numbering

Door latch

Electrical contacts

Lead groove

Figure 6. External neurostimulator with a 4-contact lead.

7.

Check that the lead contacts align with the electrical contacts inside the lead groove
and that the short stylet handle aligns with the stylet-shaped portion of the lead
groove (Figure 7).

Short stylet handle

Lead grooveElectrical contacts

Figure 7. Align the lead contacts with the electrical contacts in the lead groove.

Note:

The lead and short stylet fit only one way into the external neurostimulator lead

housing.

8.

Press the lead and short stylet gently into the lead groove (Figure 6b). If an additional
4-contact lead is used, repeat step 1 and steps 3 to 8.

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9.

Push the door(s) closed until the latch snaps firmly into place.

Note:

Do not force the doors closed; they should close easily. If they do not,

disassemble the components and repeat steps 2 to 9.

10.

Confirm correct seating by viewing the lead(s) through the closed doors.

11.

Refer to the clinician programming guide for instructions on how to reestablish
communication with the external neurostimulator and the clinician programmer, verify
proper connection, and identify optimal stimulation parameters.

Inserting 8-contact lead(s) into the wireless external neurostimulator

Check battery status before inserting the lead(s) into the external neurostimulator. Refer to
the clinician programming guide for information on checking battery status.

Caution:

Before connecting components, wipe off any body fluids and dry all
connections. Fluids in the connection may result in intermittent stimulation or loss of
stimulation.

1.

Wipe the lead contacts with dry sterile gauze.

2.

Lift the lift tab on the appropriate lead housing compartment to open the clear lead
door (Figure 8a).

3.

Make sure the lead contacts and the electrical contacts inside the lead grooves are dry
and clean.

4.

While holding the 8-contact lead, disconnect the stylet handle from the lead (proximal
end), and partially withdraw the stylet.

Note:

If connecting an extension or a lead without a stylet, proceed to step 5.

5.

Align the proximal end of the lead against the inside end of an 8-contact lead groove
of the connector (Figure 8a).

Stylet handle

Electrical contacts

Figure 8. External neurostimulator with an 8-contact lead with the stylet partially

20 English  2017-06-01

ab

Lead groove

withdrawn.

Lead groove numbering

Door latch

Retainer clips

6.

Check that the lead contacts align with the electrical contacts inside the lead groove
(Figure 9).

Stylet handle

Lead grooveElectrical contacts

Figure 9. Align the lead contacts with the electrical contacts in the lead groove.

The lead fits only one way into the external neurostimulator lead housing.

Note:

7.

Press the lead gently into the lead groove and the retainer clip (Figure 8b). If an
additional 8-contact lead is used, repeat step 1 and steps 3 to 7.

8.

Push door(s) closed until the latch snaps firmly into place.

Note:

Do not force the doors closed; they should close easily. If they do not,

disassemble the components and repeat steps 2 to 8.

9.

Confirm correct seating by viewing the lead(s) through the closed doors.

10.

Refer to the clinician programming guide for instructions on how to reestablish
communication with the external neurostimulator and the clinician programmer, verify
proper connection, and identify optimal stimulation parameters.

Preparing the wireless external neurostimulator for trial stimulation

Check the battery status and perform the check connectivity task before attaching the
external neurostimulator to the patient. Refer to the appropriate clinician programming
guide for information on checking battery status and the check connectivity task.

Note:

This procedure applies to leads and extensions.

1.

Place a gauze bandage on the skin where the lead(s) will be secured.

 2017-06-01  English 21

2.

Tape the lead(s) to the patient's skin, providing strain relief loops.

Notes:

Allow enough strain relief to ensure that the lead(s) will not be bent or kinked when

▪

connected to the external neurostimulator.
Tape the strain relief loops separately from lead exit site dressing.

▪

3.

Tape the strain relief loops and lead(s) so that the tape ends at the external
neurostimulator.

Note:

Ensure that the lead(s) are taped separately from the external neurostimulator.

4.

Affix the external neurostimulator to the patient's skin, ensuring that the
faces away from the patient.

a. Use the external neurostimulator boot to adhere the external neurostimulator to

the patient's skin. The boot is not sterile, so complete this activity outside of the
sterile field. Refer to the external neurostimulator boot instructions for use. Ensure

ENS

that the

b. If not using the external neurostimulator boot, place a gauze bandage where the

external neurostimulator will be placed on the patient, then tape the external
neurostimulator to the patient's skin. Ensure that the

c. Ensure that the lead door seams or the external neurostimulator boot are not

completely covered by bandages or tape in order to reduce humidity and
condensation in the device, which may result in loss of stimulation. Ensure that the

ENS

5.

Proceed with the trial stimulation.

button is exposed.

button is exposed.

ENS

button is exposed.

Removing the wireless external neurostimulator after trial stimulation

1.

Use the clinician programmer or controller to turn stimulation off.

2.

Remove all tape from the lead(s) and external neurostimulator.

3.

Lift the lift tabs to open the lead doors.

4.

Gently lift each lead from the electrical contacts in the lead groove.

Note:

Refer to the lead manual for instructions on the removal of the lead(s) following

trial stimulation, as appropriate.

5.

If required by local regulation, refer to the clinician programming guide for instructions
about how to update the patient data on the external neurostimulator for disposal.

6.

Dispose of the external neurostimulator according to environmental requirements.

ENS

button

Device care and storage

Keep new AAA alkaline batteries available. For optimal performance, use the same

▪

batteries as those supplied by Medtronic.
Use the clinician programmer or the controller to check the external neurostimulator

▪

battery level daily. For instructions on checking the external neurostimulator batteries,
refer to the appropriate clinician programming guide.

22 English  2017-06-01

Replace low or depleted batteries.

▪

Handle the device and system components with care. Do not drop, strike or step on

▪

the device or system components.
Do not dismantle or tamper with the device.

▪

Store the external neurostimulator at room temperature. Avoid extreme hot or cold

▪

temperatures and direct sunlight.
The device and system components are not waterproof. Do not allow moisture or

▪

condensation to get inside the device or system components.
Dispose of depleted batteries and devices according to local requirements.

▪

Safety and technical checks

Periodic safety and technical checks or periodic maintenance of the external
neurostimulator are not required.

The external neurostimulator contains no serviceable components. If the external
neurostimulator is nonfunctional, contact Medtronic. Refer to the list of Medtronic contacts
at the end of this manual.

 2017-06-01  English 23

Contacts:

Asia:

Medtronic International Ltd.
Tel. [phone]
Fax [phone]

Medtronic Asia Ltd.
Tel. [phone]

Fax [phone]

Australia:

Medtronic Australasia P/L
5 Alma Road
Macquarie Park NSW 2113
Australia
Tel. [phone]
Fax [phone]
Toll-free 1-800-668-670

Austria:

Medtronic Österreich GmbH
Tel. [phone]
Fax [phone]

Belgium:

Medtronic Belgium S.A.
Tel. [phone]
Fax [phone]

Canada:

Medtronic of Canada Ltd.
Tel. [phone]
Fax (1905)-826-6620

Czech Republic:

Medtronic Czechia s.r.o.
Tel. [phone]
Fax [phone]

Denmark:

Medtronic Danmark A/S
Tel. [phone]
Fax [phone]

Finland:

Medtronic Finland Oy/LTD
Tel. [phone]
Fax [phone]

France:

Medtronic France S.A.S.
Tel. [phone]
Fax [phone]

Germany:

Medtronic GmbH
Tel. [phone]
Fax [phone]

Greece:

Medtronic Hellas S.A.
Tel. [phone]
Fax [phone]

Hungary:

Medtronic Hungária Kft.
Tel. [phone]
Fax [phone]

Ireland:

Medtronic Ireland Ltd.
Tel. [phone]
Fax [phone]

Italy:

Medtronic Italia SpA
Tel. [phone]
Fax [phone]

Tel. [phone]
Fax [phone]

Japan:

Medtronic Japan
Tel. [phone]
Fax [phone]

Latin America:

Medtronic, Inc.
Tel. [phone]
Fax [phone]

Norway:

Medtronic Norge AS
Tel. [phone]
Fax [phone]

Poland:

Medtronic Poland Sp. z.o.o.
Tel. [phone]
Fax [phone]

Portugal:

Medtronic Portugal, Lda.
Tel. [phone]
Fax [phone]

Russia:

Medtronic Russia
Tel. [phone]
Fax [phone]

Slovakia:

Medtronic Slovakia, o.z.
Tel. [phone]
Fax [phone]

Spain:

Medtronic Ibérica, S.A.
Tel. [phone]
Fax [phone]

Sweden:

Medtronic AB
Tel. [phone]
Fax [phone]

Switzerland:

Medtronic (Schweiz) AG
Tel. [phone]
Fax [phone]

The Netherlands:

Medtronic B.V.
Tel. [phone]
Fax [phone]

Turkey:

Medtronic Turkey
Tel. [phone]
Fax [phone]

U.K.:

Medtronic U.K. Ltd.
Tel. [phone]
Fax [phone]

USA:

Medtronic, Inc.
Tel. [phone]
Fax [phone]
Toll-free: (1-800)-328-0810

Manufacturer

Medtronic, Inc.
710 Medtronic Parkway,
Minneapolis, MN 55432-5604,
USA
www.medtronic.com
Tel. [phone]
Fax [phone]

REP

Authorized Representative
in the European Community

Medtronic B.V.
Earl Bakkenstraat 10,
6422 PJ Heerlen,
The Netherlands
Tel. [phone]
Fax [phone]

Europe/Africa/Middle East Headquarters

Medtronic International Trading Sàrl
Route du Molliau 31,
Case Postale 84
CH - 1131 Tolochenaz,
Switzerland
www.medtronic.eu
Tel. [phone]
Fax [phone]

Asia-Pacific

Medtronic International Ltd.
Suite 1106-11, 11/F, Tower 1, The Gateway,
25 Canton Road, Tsimshatsui,
Kowloon,
Hong Kong
Tel. [phone]
Fax [phone]

Contacts for specific countries are listed inside this cover.

EC

*M946491A005*

© Medtronic, Inc. 2017
All Rights Reserved

M946491A005 Rev A