Medtronic 37612 User Manual

Activa® RC

Multi-program rechargeable neurostimulator

Implant manual

  Rx only

37612

2008

Explanation of symbols on product or package labeling

Refer to the appropriate product for symbols that apply.

Open here

Do not reuse

Sterilized using ethylene oxide

-XX °C

-XX °F

EO

Date of manufacture

Manufacturer

Use by

+XX °C

Temperature limitation

+XXX °F

Serial number

Consult instructions for use

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

Do not resterilize

2

STERILIZE

STERILE

PIN No.

Do not use if package is damaged

For USA audiences only

Pin number

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

4 English  37612 2016-06-01

Table of contents

Description 7

Package contents 7

Patient identification card 7

Device specifications 7

Declaration of conformity 10

Instructions for use 11

Charging the neurostimulator battery 11
Verifying neurostimulator operation 11
Connecting the extension to the neurostimulator 12
Implanting the neurostimulator 14
Checking system integrity 15
Completing the implant procedure 15

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 System Eligibility, Battery Longevity, Specifications 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.

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Description

The Medtronic Activa RC Model 37612 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-programmable, rechargeable device that delivers stimulation
through 1 or 2 leads. 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 four programs can be combined into a group, with a maximum
of 2 programs per lead. 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, ramping, and cycling for each program within the group
have the same values.

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Table 1. Operating values for the Activa RC Model 37612 neurostimulator

Programmable parameter

Number of defined groups

Number of programs per group

Electrode configuration Up to 4 electrodes as anode, cathode, or Off

Operating range and resolution

b

1 to 4

b

1 to 4

Case defined as anode or Off

a

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 By hemisphere:

Amplitude – lower patient limit By hemisphere:

Tracking limit: +0 to +2 (0.2 resolution); +2 to +4.5 (0.5
resolution)

Tracking limit: -0 to -2 (0.2 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

a

Interlocks will prevent the use of some parameter combinations.

b

No more than 16 programs may be defined within the 4 groups.

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.

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)

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Table 2. Physical characteristics of the Activa RC Model 37612 neurostimulator

Description Value

Connector type Octapolar, in-line 2.8-mm (0.110-in) spacing
Height 54 mm (2.1 in)
Length 54 mm (2.1 in)
Thickness

case 9 mm (0.4 in)

connector 11 mm (0.4 in)
Weight 40 g (1.4 oz)
Volume

22 cm

3

Battery life 9 years

Power source

b

Lithium ion rechargeable battery

Storage temperature –18° to +52°C (0° to +126°F)

Serial number model designator

c

NKG

Radiopaque Identification (ID) code NKG
Transmitter

Carrier frequency 175 kHz

Output level (at 300 m) -48 dBuV/m

a

All measurements are approximate.

b

The neurostimulator is not shipped with a full battery charge. Refer to the charging system user manual
for neurostimulator charging instructions.

c

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 RC Model 37612 package

Components Material Material contacts

Neurostimulator

Case Titanium Yes
Connector block Polysulfone, 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 have expertise with functional stereotactic neurosurgical treatment of movement
disorders and should be thoroughly familiar with all product labeling.

Warning: DO NOT use the recharger on an unhealed wound. The recharger,
antenna, and holster are not sterile, and contact with the wound can cause an
infection.

Caution: Advise patients to charge the neurostimulator on a regular basis, taking into
consideration the therapeutic parameters and battery usage of the patient, to prevent
the battery from overdischarging. If the neurostimulator battery is allowed to
overdischarge, the patient cannot charge the neurostimulator; however, the clinician
may be able to restore the battery function using the Physician Recharge Mode on
the recharger (refer to the troubleshooting section of the software manual).

Allowing the neurostimulator battery to overdischarge will permanently affect the
neurostimulator in one of the following ways:

Battery function is restored; however, charging sessions may be more frequent

▪

because battery capacity has been reduced.
Battery function is not restored and the neurostimulator must be surgically

▪

replaced. Battery function is not restored when:

the neurostimulator battery is permanently damaged.

–

the neurostimulator battery has been overdischarged and restored twice

–

before. The third time the battery is overdischarged, the neurostimulator will
reach end of service. Surgery is required to replace the neurostimulator.

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.

Charging the neurostimulator battery

Charge the neurostimulator battery before opening the package. For charging instructions,
refer to the charging system user manual.

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 charge level. (Refer to the software manual for instructions on how
to read the battery charge level.)

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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 connectors 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 each extension connector into the appropriate neurostimulator socket until it is

seated fully within the connector block (Figure 1).

Notes:

During insertion, some resistance is typical.

▪

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.

Caution: Do not insert the extension connector into the connector block if the
setscrews are not sufficiently retracted. If the setscrews are not retracted, the
setscrews may damage the extension and the extension will not be seated fully
into the connector block.

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Socket II (Electrodes 8-15)

Socket I (Electrodes 0-7)

Extension 1

Extension 2

Figure 1. Insert the extension connectors into the neurostimulator.

Note: Insert a connector plug (from an accessory kit) into unused neurostimulator
socket.

4. For each extension or plug, fully insert the torque wrench (packaged with the

neurostimulator) into each self-sealing grommet of the connector block and tighten
each setscrew (Figure 2).

Cautions:

To prevent undertightening the neurostimulator setscrews, do not use the

▪

torque wrench from the extension kit. Undertightening may result in
insufficient electrical contact within the connector block, which may cause
intermittent stimulation.

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 setscrews, ensure that the extension connector is inserted

▪

into the connector block to prevent damaging the extension.
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.

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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 1 cm (0.4 in) below

▪

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

Position the neurostimulator with the Medtronic logo facing outward. If

▪

implanted with the Medtronic logo facing inward, the neurostimulator will be
difficult to charge.

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 and recharge operation.
Excess extension should not exceed two wraps around the perimeter of the
neurostimulator. Extension lengths requiring more than two wraps can
interfere with telemetry.

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Figure 3. Wrap excess extensions 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 each extension to the neurostimulator, use the

clinician programmer to program the 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 12.

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

*M927170A049*

© Medtronic, Inc. 2016
All Rights Reserved

M927170A049 Rev A