Medtronic 97713 User Manual

RestoreAdvanced® SureScan® MRI

Rechargeable neurostimulator

Implant manual

  Rx only

97713

2013

Explanation of symbols on product or package labeling

Refer to the appropriate product for symbols that apply.

Open here

Do not use if package is damaged

Do not reuse

Do not resterilize

2

STERILIZE

Sterilized using ethylene oxide

-XX °C

-XX °F

EC

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

STERILE

For USA audiences only

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

®

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Table of contents

Description 7

Neurostimulation systems with SureScan MRI Technology 7

Package contents 7

Patient identification card 7

Device specifications 7

Declaration of conformity 10

Implanted components and MRI scans 11

Implant criteria for full-body MRI scan eligibility 11
When changing components 11
When explanting components 12

Instructions for use 12

Charging the neurostimulator battery 12
Verifying neurostimulator operation 12
Connecting the extension or lead to the neurostimulator 13
Implanting the neurostimulator 15

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 the MRI Guidelines for Medtronic Neurostimulation Systems for Chronic
Pain instructions for use manual for the MRI conditions and MRI-specific warnings
and precautions for conducting an MRI scan.

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

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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Checking system integrity 17
Completing the implant procedure 17

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