Medtronic 37602 User Manual

Activa® SC

Multi-program neurostimulator

Implant manual

  Rx only

37602

2010

Explanation of symbols on product or package labeling

Refer to the appropriate product for symbols that apply.

Open here

Do not reuse

Do not resterilize

2

STERILIZE

Sterilized using ethylene oxide

-XX °C

-XX °F

EO

Consult instructions for use

Date of manufacture

Manufacturer

Use by

XX °C

Temperature limitation

XXX °F

Serial number

Conformité Européenne (European Conformity). This symbol means
that the device fully complies with AIMD Directive 90/385/EEC
(NB 0123).

Authorized representative in the European Community

REP

EC

For USA audiences only

STERILE

Do not use if package is damaged

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PIN No.

Pin number

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

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Table of contents

Description 9

Package contents 9

Patient identification card 9

Device specifications 9

Declaration of conformity 12

Instructions for use 13

Verifying neurostimulator operation 13
Connecting the extension to the neurostimulator 13
Implanting the neurostimulator 15
Checking system integrity 16
Completing the implant procedure 16

Refer to the indications sheet for indications and related information.

Refer to the appropriate information for prescribers booklet and any additional
associated product information for contraindications, warnings, precautions,
component disposal, and other important device therapy information.

Refer to the MRI Guidelines for Medtronic Deep Brain Stimulation Systems
instructions for use manual for the MRI conditions and MRI-specific
contraindication, warnings, and precautions for conducting an MRI scan.

Refer to the System Eligibility Battery Longevity reference manual for
neurostimulator selection and battery longevity calculations.

! USA

Refer to the clinical summary booklet for information on the clinical study
results of the neurostimulation system, individualization of treatment, adverse
events summary, and use in specific populations.

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Description

The Medtronic Activa SC Model 37602 Neurostimulator is part of a neurostimulation system
for deep brain stimulation.

Package contents

Neurostimulator

▪

Torque wrench

▪

Product literature

▪

Warranty card

▪

Registration form

▪

Patient identification card

▪

Patient identification card

A patient identification card is packaged with this device. Advise the patient to carry the
identification card at all times.

! USA

The patient identification card packaged with the device is temporary; a permanent

card will be mailed to the patient when Medtronic receives the registration form.
The implant registration form registers the device warranties and creates a record of the

device in Medtronic’s implant data system.

Device specifications

The neurostimulator is a multi-program device that delivers stimulation through one lead.
The stimulation settings are stored in programs. A program is a specific combination of
pulse width, rate, and amplitude settings acting on a specific electrode combination. Up to
two programs can be combined into a group. When using more than one program, the
pulses are delivered sequentially—first a pulse from one program, then a pulse from the
next program.

Pulse width, amplitude, and electrode polarity for each program within the group can have
different values. Rate, rate limits, SoftStart/Stop and Cycling for each program within the
group have the same values.

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Table 1. Operating values for the Activa SC Model 37602 neurostimulator

Programmable parameter

Operating range and resolution

a

Number of defined groups 1 to 4
Number of programs per group 1 to 2

Electrode configuration

b

1 to 4 electrodes per lead as anode (+), cathode (–), or

Off; case defined as anode or Off
Amplitude (voltage mode) 0 to 10.5 V with 0.05-V or 0.1-V resolution
Amplitude (current mode) 0 to 25.5 mA with 0.1-mA resolution
Amplitude – upper patient limit Tracking limit (by hemisphere): +0 to +2 (0.2 resolution);

Amplitude – lower patient limit Tracking limit (by hemisphere): –0 to –2 (0.2 resolution);

+2 to +4.5 (0.5 resolution)

–2 to –4.0 (0.5 resolution); full range

c

Pulse width 60 to 450 µs (10-µs resolution)
Pulse width – upper patient limit Tracking limit: +0 to +100 µs (10-µs resolution)
Pulse width – lower patient limit Tracking limit: –0 to –100 µs (10-µs resolution)
Rate (voltage mode) 2 to 250 Hz (resolution: 1 Hz from 2 Hz to 10 Hz, 5 Hz

from 10 Hz to 250 Hz)
Rate (current mode)

30 to 250 Hz (5-Hz resolution)

d

d

Rate – upper patient limit Tracking limit: +0 to +50 Hz (10-Hz resolution)
Rate – lower patient limit Tracking limit: –0 to –50 Hz (10-Hz resolution)
SoftStart/Stop Off, On: 1-, 2-, 4-, or 8-second ramp duration
Cycling Off, On: 0.1 s to 24 hr (resolution: 0.1 s from 0.1 s to

1 s, 1 s from 1 s to 59 s, 1 min from 1 min to 59 min,

1 hr from 1 hr to 24 hr)

a

Interlocks will prevent the use of some parameter combinations.

b

In current mode, a maximum of 2 electrodes (including the case) can be configured: one as anode (+) and
one as cathode (–).

c

Full range = –10.5 V (voltage mode); –25.5 mA (current mode).

d

Rate limited to 125 Hz when two programs are active on a single lead.

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Table 2. Physical characteristics of the Activa SC Model 37602 neurostimulator

Description Value

Connector type

Quadrapolar, two bore

b

Height 55 mm (2.2 in)
Length 60 mm (2.4 in)
Thickness 11 mm (0.4 in)
Weight 45 g (1.6 oz)
Volume

Power source

3

28 cm

4.5 Amp hours, 3.2 V HCSVO

c

cell
Temperature limitation –18 °C to +52 °C (0 °F to +126 °F)

Serial number model designator

d

NLA

Radiopaque identification (ID) code NLA
Transmitter

Carrier frequency 175 kHz
Output level (at 300 m) –48.7 dBuV/m

a

All measurements are approximate.

b

Compatible with two-pronged extension.

c

Hybrid combined silver vanadium oxide.

d

The serial number is the model designator followed by a number. The clinician programmer displays the
entire serial number beginning with the model designator.

a

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Table 3. Material of components in the Activa SC Model 37602 package

Components Material Material contacts

Neurostimulator

Case Titanium Yes
Connector block Polyurethane, silicone rubber,

Grommets, seals Silicone rubber Yes
Setscrews Titanium alloy Yes
Adhesive Silicone medical adhesive Yes

Torque wrench

Handle Polyetherimide Yes
Shaft Stainless steel Yes

silicone medical adhesive

human tissue

Yes

Declaration of conformity

Medtronic declares that this product is in conformity with the essential requirements of
Directive 90/385/EEC on Active Implantable 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

Implanting physicians should be experienced in stereotactic and functional neurosurgery
and deep brain stimulation procedures, as well as thoroughly familiar with all product
labeling.

Cautions:

When using sharp instruments near the neurostimulator, be extremely careful to

▪

avoid nicking or damaging the case or the connector block. Damaging the
neurostimulator may require surgical replacement.

Do not use saline or other ionic fluids at connections, which could result in a short

▪

circuit.

Verifying neurostimulator operation

Before opening the sterile neurostimulator package, verify that the neurostimulator is
operable by using the clinician programmer to interrogate the neurostimulator and read the
neurostimulator battery service life. (Refer to the software manual for instructions on how to
read the battery service life.)

Caution: Do not implant a neurostimulator if it was dropped onto a hard surface from
a height of 30 cm (12 in) or more, because the neurostimulator may be damaged and
fail to operate properly.

Note: The neurostimulator pocket may be flushed with an antibiotic solution; do not
submerge the neurostimulator in fluid.

Connecting the extension to the neurostimulator

Caution: Before connecting components, wipe off any body fluids and dry all

connections. Fluids in the connection may result in stimulation at the connection site,
intermittent stimulation, or loss of stimulation.

1. Wipe the extension connector pins with sterile gauze. If necessary, use sterile (United
States Pharmacopeia [USP]) water or a nonionic antibiotic solution.

2. Make sure the connector block receptacles are dry and clean.

3. Insert the appropriate extension connector pins into the appropriate neurostimulator

socket until they are seated fully within the connector block (Figure 1). If resistance is
felt while inserting the connector pins, use the torque wrench (packaged with the
neurostimulator) to retract the setscrews.

Note: To retract the setscrews, insert the torque wrench into the self-sealing grommet
and rotate the setscrews counterclockwise; however, do not remove the setscrews
from the connector block.

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Cautions:

Do not insert the extension connector into the connector block if the

▪

setscrews are not sufficiently retracted. If the setscrews are not retracted,
the extension connector pins may damage the setscrews and the extension
connector pins will not be seated fully into the connector block.

Limit counter-clockwise rotations of the neurostimulator setscrews when

▪

retracting them. Too many counter-clockwise rotations may disengage the
setscrew from the connector block.

Figure 1. Insert the extension connector pins fully into the neurostimulator.

4. Fully insert the torque wrench into each self-sealing grommet of the connector block
and tighten each setscrew (Figure 2).

Note: The torque wrench must be oriented to the same angle as the setscrew
(Figure 2).

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Cautions:

Be sure the torque wrench is fully inserted into the self-sealing grommet. If

▪

the torque wrench is not fully inserted, the setscrew may be damaged,
resulting in intermittent or loss of stimulation.

Before tightening the setscrews, ensure that the extension connector pins

▪

are inserted into the connector block to prevent damaging the connector
block.

Verify that each leaf of the self-sealing grommet is closed after the torque

▪

wrench is withdrawn. If fluid leaks through a grommet seal that is not fully
closed, the patient may experience shocking, burning, or irritation at the
neurostimulator implant location, or intermittent stimulation or loss of
stimulation may occur.

Figure 2. Tightening the setscrews in the self-sealing grommet.

Implanting the neurostimulator

1. Place the neurostimulator into the subcutaneous pocket with the Medtronic logo

facing outward, away from muscle tissue, and ensure that the extension is not bent
sharply.

Cautions:

Ensure that the neurostimulator is placed no deeper than 4 cm (1.5 in)

▪

below the skin and is parallel to the skin. If the neurostimulator is too deep
or is not parallel to the skin, telemetry may be unsuccessful.

Do not coil excess extension in front of the neurostimulator. Wrap excess

▪

extension around the perimeter (Figure 3) of the neurostimulator to minimize
subcutaneous pocket depth, help minimize potential damage during
neurostimulator replacement surgery, help minimize potential kinking of the
extension, and minimize interference with telemetry. Excess extension
should not exceed two wraps around the perimeter of the neurostimulator.

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Extension lengths requiring more than two wraps can interfere with
telemetry.

Figure 3. Wrap excess extension around the perimeter of the neurostimulator.

2. Use the suture holes in the connector block to secure the neurostimulator to the
muscle fascia with nonabsorbable silk.

Checking system integrity

Caution: To use the nonsterile clinician programmer in a sterile field, place a sterile

barrier between the patient and the programming head to prevent infection. Do not
sterilize any part of the clinician programmer. Sterilization may damage the
programmer.

Note: The neurostimulator should be in the pocket during system interrogation for integrity
to ensure proper readings.

1. To ensure proper connection of the extension to the neurostimulator, use the clinician
programmer to program the lead configuration and basic stimulation parameters,
check the battery status, and check the electrode impedances to rule out a short or
open circuit.

2. If the system integrity test results are not acceptable, refer to "Connecting the
extension to the neurostimulator" on page 13.

Completing the implant procedure

1. Close and dress all incisions.

2. Ensure that a patient control device is given to the patient.

3. Complete the device tracking and patient registration paperwork and return the

documents to Medtronic.

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Contacts:

Asia:

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

Medtronic Asia Ltd.
Tel. [phone]

Fax [phone]

Australia:

Medtronic Australasia Pty. Ltd.
97 Waterloo Road
North Ryde, 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

*M939238A038*

© Medtronic, Inc. 2016
All Rights Reserved

M939238A038 Rev A