Medtronic 3531 User Manual
Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
ImplantManual.xsl - IPGTemplate.fm
Medtronic Confidential
Template version: 12-13-2011
VERIFYTM EXTERNAL
NEUROSTIMULATOR
User manual
! USA
Rx only
3531
M943581A001 Rev X
2013-03
Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
ImplantManual.xsl - IPGTemplate.fm
Medtronic Confidential
Template version: 12-13-2011
M943581A001 Rev X
2013-03
Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
ImplantManual.xsl - IPGTemplate.fm
Template version: 12-13-2011
Explanation of symbols on product or package labeling
Refer to the appropriate product for symbols that apply.
Conformité Européenne (European Conformity). This symbol means that the
device fully complies with MDD 93/42/EEC (NB 0123) and R&TTE Directive
1999/5/EC.
System meets the applicable Canadian (CAN/CSA-C22.2 No. 60601-1)
electrical safety standard requirements.
Do not reuse
Consult instructions for use
Serial number
Manufacturer
Authorized representative in the European community
REP
EC
IEC60601-1/EN60601-1, Type BF equipment
Non-ionizing electromagnetic radiation
XX °C
Temperature limitation
XXX °F
-XX °C
-XX °F
For USA audiences only
Medtronic Confidential
Do not dispose of this product in the unsorted municipal waste stream. Dispose
of this product according to local regulations. See http://recycling.medtronic.com
for instructions on proper disposal of this product.
Chinese Standard (SJ/T11364-2006) Logo: Electronic Information Products
Pollution Control Symbol. (The date in this logo means the environmental
protection use period of the product.)
M943581A001 Rev X
2013-03 English 1
2013-03
Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
ImplantManual.xsl - IPGTemplate.fm
Template version: 12-13-2011
Medtronic Confidential
Medtronic® is a trademark of Medtronic, Inc., registered in the U.S. and other countries.
TM
Verify
is a trademark of Medtronic, Inc.
®
Bluetooth
! USA
is a registered trademark of Bluetooth SIG, Inc.
FCC Information
The following is communications regulation information on the Model 3531 External
Neurostimulator.
FCC ID: LF53531
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
IMPORTANT: Changes or modifications to this product not authorized by Medtronic,
Inc., could void the FCC Certification and negate your authority to operate this
product.
This device complies with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions: (1) this device may not cause interference, and (2) this
device must accept any interference, including interference that may cause undesired
operation of the device.
2 English 2013-03
2013-03
M943581A001 Rev X
Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
ImplantManual.xsl - IPGTemplate.fm
Template version: 12-13-2011
Medtronic Confidential
Table of contents
Purpose of the device 5
Description 5
Package contents 5
Device specifications 5
Declaration of Conformity 8
Instructions for use 9
Pairing the external neurostimulator to the controller 9
Using the external neurostimulator during test stimulation 9
Replacing the external neurostimulator batteries 10
Using the external neurostimulator boot 12
Using the external neurostimulator belt 13
Device care and storage 15
Safety and technical checks 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 Test stimulation lead implant manual packaged with the test stimulation
lead for test stimulation-specific 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.
! USA
Refer to the clinical summary booklet for information on the clinical study
results of the neurostimulation system and individualization of treatment.
2013-03 English 3
M943581A001 Rev X
2013-03
Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
ImplantManual.xsl - IPGTemplate.fm
Medtronic Confidential
Template version: 12-13-2011
4 English 2013-03
2013-03
M943581A001 Rev X
Loading...