Medtronic 97715, 97716 User Manual
Filename Date Time
UC200xxxxxx EN
4.6 x 6 inches (117 mm x 152 mm)
Intellis™ 97715
Rechargeable neurostimulator
ImplantManual.xsl - IPGTemplate.fm
Medtronic Confidential
Template version: 08-02-2011
M946871A001
Implant manual
! USA
Rx only
2012
2012-06
Filename Date Time
UC200xxxxxx EN
4.6 x 6 inches (117 mm x 152 mm)
ImplantManual.xsl - IPGTemplate.fm
Medtronic Confidential
Template version: 08-02-2011
M946871A001
2012-06
Filename Date Time
UC200xxxxxx EN
4.6 x 6 inches (117 mm x 152 mm)
ImplantManual.xsl - IPGTemplate.fm
Template version: 08-02-2011
Explanation of symbols on product or package labeling
Refer to the appropriate product for symbols that apply.
Conformité Europ éenne (European Conformity). This symbol means that the
device fully complies with AIMD Directive 90/385/EEC (NB 0123) and
R&TTE Directive 1999/5/EC.
Warning
Consult instructions for use
Do not reuse
Do not resterilize
2
STERILIZE
Date of manufacture
Manufacturer
Open here
Use by
Serial number
Medtronic Confidential
STERILE
EC
! USA
XXX °F
-XX °C
-XX °F
M946871A001
Sterilized using ethylene oxide
EO
Authorized Representative in the European Community
REP
For USA audiences only
XX °C
Temperature limitation
97715 2012-06 English 1
2012-06
Filename Date Time
UC200xxxxxx EN
4.6 x 6 inches (117 mm x 152 mm)
ImplantManual.xsl - IPGTemplate.fm
Template version: 08-02-2011
Medtronic Confidential
Medtronic® and SoftStart/Stop® are trademarks of Medtronic, Inc., registered in the U.S. and
other countries.
AdaptiveStim™ and Intellis™ are trademarks of Medtronic, Inc.
2 English 97715 2012-06
2012-06
M946871A001
Filename Date Time
UC200xxxxxx EN
4.6 x 6 inches (117 mm x 152 mm)
Table of contents
Description 5
Package contents 5
Patient identification card 5
Device specifications 5
Declaration of conformity 8
Instructions for use 9
Charging the neurostimulator battery 9
Verifying neurostimulator operation 9
Connecting the extension or lead to the neurostimulator 10
Implanting the neurostimulator 11
Checking system integrity 12
Completing the implant procedure 12
ImplantManual.xsl - IPGTemplate.fm
Medtronic Confidential
Template version: 08-02-2011
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.
Refer to the clinical summary booklet for information on the clinical study
results of the neurostimulation system and individualization of treatment.
97715 2012-06 English 3
M946871A001
2012-06
Filename Date Time
UC200xxxxxx EN
4.6 x 6 inches (117 mm x 152 mm)
ImplantManual.xsl - IPGTemplate.fm
Medtronic Confidential
Template version: 08-02-2011
4 English 97715 2012-06
2012-06
M946871A001
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