Medtronic 97745 User Manual
NEUROMODULATION
257
CONFIDENTIAL
DOCUMENT/RECORD
This document/record is electronically controlled, printed copies are considered uncontrolled.
Identifier Version Author
NDHF1245-121586 4.0 Monica Tuy
Title:
97745 User Manual DRAFT for Agency and Summative Testing
Pages:
(including this page)
APPROVALS
Signed By Responsibility Date/Time (GMT)
Monica Tuy Technical Communications Approver 7/12/2012 5:42:48 PM
Form MEDN-0500 version 3.0
Filename Date Time
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4.625″ x 6.0″ inches (117 mm x 152 mm)
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CONTROLLER
Pain therapy user manual for Intellis
97715 and Model 97725 Wireless External
Neurostimulation Systems
™
Model
97745
! USA
Rx only
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2013
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4.625″ x 6.0″ inches (117 mm x 152 mm)
Medtronic®, AdaptiveStim®, and SoftStart/Stop® are
trademarks of Medtronic, Inc., registered in the U.S. and
other countries.
Intellis™ is a trademark of Medtronic, Inc.
! USA
FCC Information
The following is communications regulation information
on the Model 97745 Controller.
FCC ID: LF597745
This device complies with Part 15 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 licenseexempt 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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Label Symbols
Explanation of symbols on products and
packaging. Refer to the appropriate product to
see symbols that apply.
Conformité Européenne (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.
Consult instructions for use
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MR
Magnetic Resonance (MR) Unsafe
Manufacturer
Serial number
PIN No.
REP
EC
PIN number
Authorized representative in the European
community
+XX °C
-XX °C
-XX °F
+XXX °F
Temperature limitation
Non-ionizing electromagnetic radiation
IEC 60601-1/EN60601-1, Type BF
Equipment
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System meets the applicable Canadian
(CAN/CSA-C22.2 No. 60601-1) and US
(UL 60601-1:2003) electrical safety
standard requirements.
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.)
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.
For USA audiences only
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Table of contents
Label Symbols 3
Glossary 12
Introduction 20
1
How to use this manual 20
Patient guides 22
Patient identification card 25
2 Important therapy
information 28
Purpose of the device 28
Purpose of the neurostimulation system
(indications) 28
Description of your system 29
Therapies that may not be used with the
neurostimulation system
(contraindications) 33
Risks and benefits 33
Risks of surgery 34
Warnings 34
Precautions 43
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Individualization of Treatment 48
3 Recovery and care after
surgery 52
Recovery from surgery 52
Activities 52
When to call your clinician 54
Care schedule 55
4 Using your controller 58
How your controller works 58
Controller screen and keys 59
Home screen 62
Unlocking and locking your
controller 65
Unlocking your controller 65
Locking your controller 69
Turning your stimulation on or off 70
Turning your stimulation on for all pain
areas 70
Turning your stimulation off for all pain
areas 72
How to maintain neurostimulator
batteries 75
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Checking the battery status of the controller
and neurostimulator 75
Changing controller preferences using the
Menu 80
To access the Menu screen 80
Changing the audio and vibration
settings 84
Changing the brightness of the controller
display 86
Changing the date 87
Changing the time 88
Changing the language 90
Changing the number format 91
Viewing information about the controller
and the neurostimulator 92
5 Adjusting your stimulation 96
Introduction 96
Stimulation features 96
Adjusting stimulation settings 96
Programming modes 100
Changing parameter and stimulation
settings 101
Increasing or decreasing a parameter
(intensity, pulse width, or rate) 106
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Adjusting intensity for all pain areas
together 108
Turning stimulation on or off for individual
pain areas 110
Turning cycling on or off 112
Changing a program for individual pain
areas 114
Viewing and changing a group 115
Using AdaptiveStim 117
AdaptiveStim groups and positions 119
Checking your body position 121
Turning AdaptiveStim on or off 124
Making adjustments to AdaptiveStim 125
6 MRI examinations 128
If you have an MRI appointment 128
Responsibilities of the patient in preparing
for the MRI appointment 129
At the MRI appointment 130
Determining if you are in MRI mode 131
Placing your neurostimulation system in
MRI mode for the MRI scan 133
Using your controller to activate MRI
mode 134
Table of contents
Activating MRI mode 135
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Turning stimulation back on after the MRI
scan 139
Visiting your clinician to activate MRI
mode 141
7 Using the recharging system with
the implanted
neurostimulator 146
Recharging the implanted neurostimulator
battery 146
Recharging the neurostimulator
battery 146
To stop recharging the neurostimulator
battery 154
Changing the recharging temperature and
speed 155
Recharging the controller battery
pack 158
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8 Troubleshooting 164
Controller screens 164
Warning screens 165
Alert screens 173
Notification screens 182
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Possible problems and solutions 187
9 Additional information 194
How stimulation works 194
Controlling your stimulation 199
What your clinician controls 199
What you control 199
Possible adverse effects 200
Changes in therapy 200
Possible system complications 200
10 Maintenance and
assistance 204
Accessories 204
Labeling the controller 204
Using the carrying case 205
Replacing the type AA controller
batteries 206
Replacing the controller battery pack 207
Setting up a new controller 208
Cleaning and care 219
Safety and technical checks 221
Battery and controller disposal 221
Neurostimulator disposal 221
Table of contents
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Specifications 222
User assistance 223
Declaration of conformity 224
11 Appendix A: Electromagnetic
interference (EMI) 226
Contraindication 226
Warnings 227
Precautions 238
Notes 242
Index 244
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Glossary
Caution - A statement describing actions that
could result in damage to or improper
functioning of a device.
Clinician - A healthcare professional such as
a doctor or nurse.
Clinician programmer - A device used by a
clinician to send instructions to a
neurostimulator.
Contraindication - A condition or
circumstance when a person should not
have a neurostimulation system.
Controller - A hand-held device that allows
you to turn your neurostimulator on and off
and check your neurostimulator battery. It is
also used to adjust some of the stimulation
settings.
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Diathermy - A medical treatment applied to
the outside of the body that delivers energy
into the body. Three types of energy that can
be used are shortwave, microwave, and
ultrasound. Depending on the power level
used, diathermy devices may or may not
produce heat within the body. This
treatment is typically used to relieve pain,
stiffness and muscle spasms, reduce joint
contractures, reduce swelling and pain after
surgery, and promote wound healing.
Discharged battery - The rechargeable
battery is depleted and should be charged
as soon as possible. When the battery is in
a discharged state, therapy is not
available.
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Elective replacement indicator (ERI) -
Notification that the INS is nearing or has
reached its recommended replacement
date.
Electrode - A metal piece near the tip of the
lead. Electrodes deliver electrical pulses to
the area where your pain signals will be
blocked.
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Electromagnetic interference (EMI) - A
strong field of energy near electrical or
magnetic devices that could prevent the
neurostimulator from functioning properly.
End of service (EOS) - Condition of an ENS
at the time it is no longer able to operate
successfully.
External neurostimulator (ENS) - See
Neurostimulator.
Group - Collection of programs that work
together for a particular effect or area.
Implanted neurostimulator (INS) - See
Neurostimulator.
Indication - The purpose of the
neurostimulation system and the medical
condition for which it may be implanted.
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Intensity - The strength of an electrical
pulse.
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Neurostimulation system - The implanted
and external components of the stimulation
system that delivers electrical pulses to
block pain signals as they move to the
brain.
Neurostimulator - The power source of a
neurostimulation system. It contains the
battery and electronics that control the
stimulation you feel. An external
neurostimulator is carried outside the body.
During test stimulation, it is used to
determine whether or not stimulation is
effective. An implanted neurostimulator is
placed inside the body. If stimulation is
effective during test stimulation, the
neurostimulator is implanted.
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Out-of-regulation (OOR) - The
neurostimulator battery is unable to produce
the levels of energy required for the current
stimulation settings.
Pain areas - An area of the body where a
patient feels pain.
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