Medtronic 97725 User Manual
Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
Wireless External Neurostimulator 97725
ImplantManual.xsl - IPGTemplate.fm
Medtronic Confidential
Template version: 05-31-2012
User manual
! USA
Rx only
M946491A001 Rev X
2013-04
Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
ImplantManual.xsl - IPGTemplate.fm
Medtronic Confidential
Template version: 05-31-2012
M946491A001 Rev X
2013-04
Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
ImplantManual.xsl - IPGTemplate.fm
Template version: 05-31-2012
Explanation of symbols on product or package labeling
Refer to the appropriate product for symbols that apply.
Consult instructions for use
Do not reuse
Use by
Sterilized using ethylene oxide
-XX °C
-XX °F
EO
Do not resterilize
2
STERILIZE
Manufacturer
Date of manufacture
XX °C
Temperature limitation
XXX °F
Magnetic Resonance (MR) Unsafe
MR
Non-ionizing electromagnetic radiation
STERILE
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Serial number
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.)
System meets the applicable Canadian (CAN/CSA-C22.2 No. 60601-1) and
US (UL 60601-1:2003) electrical safety standard requirements.
IEC60601-1/EN60601-1, Type BF equipment
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Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
Conformité Europ éenne (European Conformity). This symbol means that the
device fully complies with MDD 93/42/EEC (NB 0123) and R&TTE Directive
1999/5/EC.
Authorized Representative in the European Community
REP
EC
For USA audiences only
Do not use of the package is damaged.
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.
ImplantManual.xsl - IPGTemplate.fm
Medtronic Confidential
Template version: 05-31-2012
2 English 2013-04
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M946491A001 Rev X
Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
ImplantManual.xsl - IPGTemplate.fm
Template version: 05-31-2012
Medtronic Confidential
Medtronic® and SoftStart/Stop® are trademarks of Medtronic, Inc., registered in the US and
other countries.
®
Bluetooth
! USA
is a registered trademark of Bluetooth SIG, Inc.
FCC Information
The following is communications regulation information on the Model 97725 Wireless External
Neurostimulator.
FCC ID: LF597725
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.
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UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
ImplantManual.xsl - IPGTemplate.fm
Template version: 05-31-2012
Table of contents
Purpose of the device 5
Description 5
Package contents 5
Accessories 5
Device specifications 5
Declaration of Conformity 9
Instructions for use 10
Pairing the wireless external neurostimulator to a programmer or controller 10
Using the wireless external neurostimulator during test stimulation 10
Replacing the wireless external neurostimulator batteries 11
Changing the batteries during test stimulation 11
Changing the batteries before test stimulation 12
Connecting the wireless external neurostimulator to the leads 14
Connecting the wireless external neurostimulator to the 4-contact lead(s) 14
Connecting the wireless external neurostimulator to the 8-contact lead(s) 16
Preparing the wireless external neurostimulator for test stimulation 18
Removing the wireless external neurostimulator after test stimulation 18
Device care and storage 18
Safety and technical checks 19
Refer to the indications sheet for indications and related information.
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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.
! USA
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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ImplantManual.xsl - IPGTemplate.fm
Template version: 05-31-2012
Medtronic Confidential
Purpose of the device
The Medtronic Model 97725 Wireless External Neurostimulator (ENS) is used to evaluate a
Medtronic Neurostimulation System during lead placement or test stimulation.
Description
The Medtronic Model 97725 Wireless External Neurostimulator is a disposable, sterile, singleuse device equipped with Bluetooth wireless technology, and is part of a neurostimulation
system.
Package contents
Wireless external neurostimulator with batteries inserted
▪
Spare AAA alkaline batteries (2)
▪
Product literature
▪
! USA
Warranty card
▪
Accessories
Wireless external neurostimulator boot (packaged separately)
▪
Device specifications
The Model 97725 Wireless External Neurostimulator (Figure 1 and Figure 2) is a multiprogrammable device that delivers stimulation through 1 or more leads. The stimulation
settings are stored in programs to target pain areas. A program is a specific combination of
pulse width, rate, and intensity settings acting on a specific electrode combination (up to 16
electrodes per program). Up to 4 pain areas can be targeted by programs. When stimulating
more than one pain area, the pulses are delivered sequentially—first a pulse from one
program, then a pulse from the next program.
Pulse width, intensity, cycling, and electrode polarity for each program within a group can have
different values. Rate, rate limits, pulse width limits, and inten sity limits for each program within
a group have the same values.
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Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
ImplantManual.xsl - IPGTemplate.fm
Medtronic Confidential
Template version: 05-31-2012
ENS button
Lead housing
compartment,
black (electrodes 8-15)
Lift tabs
Lead doors
Lead housing
compartment,
white (electrodes 0-7)
Figure 1. Model 97725 Wireless External Neurostimulator (doors closed).
8 - contact
lead groove
Electrical
contacts
4 - contact
lead groove
Retainer clip
Figure 2. Model 97725 Wireless Exernal Neurostimulator (doors open).
Table 1. Operating values for the Model 97725 Wireless External Neurostimulator
Programmable parameter
Operating values and ranges
a
Number of defined groups 1-3 (optional)
Number of programs per pain
1-3
area
Number of programs
12
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