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

37612 2016-06-01  English 3

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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