Medtronic 37741 Users Manual

Neurological Medtronic Confidential
Title
Model 7439 Patient Programmer User Manual -
Global
This Document is the Property of Medtronic, Inc. and must be accounted for. Information hereon is confidential. DO NOT reproduce it, reveal it to unauthorized persons or send it outside Medtronic without proper authorization.
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Part No. Part No. Rev Comments
221244001 D Release for translation
DO NOT PRINT THIS FORM WHEN PRINTING THE LITERATURE PIECE. D
O NOT COUNT THIS FORM IN THE LITERATURE PIECE PAGE COUNT.
REVISION HISTORY: SEE PDM WEBSITE FOR INFORMATION.
1. Materials:
Covers
Grade #1, 80 lb. white gloss coated cover stock, minimum brightness level: 89
Text
60 lb. white smooth opaque text stock
Labels
N/A
2. Colors: To confirm all colors, graphics and text, refer to electronic file
Writer
Theresa King-Hunter
Date
11/03/04
Front Cover
4-color cover and solid gloss varnish
Back Cover
Black text and graphics; solid gloss varnish
Body
2-color text and graphics (PMS 301, black, percentages of PMS 301 or percentages
of black)
Labels
N/A
3. Size: 4.6 ± 0.2 (w) x 6.0 ± 0.2 (h)
4. Type of Binding: Clear plastic coil, MWE lay-flat, or perfect bound
5. Other:
Cover and text whiteness must match visually.
6. Literature Piece Page Count (Including covers, excluding this form): 136
7. Note to print supplier: Supplier may add up to three blank pages at the end of the
document before the back cover sheet as needed. If more are required, contact the
purchasing agent.
8. Vendor-supplied information may appear at an appropriate location on the literature
piece (eg, part number, bar code, etc.).
9. Graphics Content and Layout to be as shown and per Medtronic electronic file that is
supplied (stored) by Medtronic Neuro.
Page 1 Form MEDN-0043 version 7.0
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PATIENT PROGRAMMER 7439
Pain therapy user manual
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c Rx only
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The following are trademarks of Medtronic, Inc.: Medtronic®, MyStim™, SoftStart™, Synergy Plus+™, Synergy Compact+™, and Synergy
®
.
c FCC Information
The following is communications regulation information on the Model 7439 Patient Programmer.
FCC ID: LF537741
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.
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Contents
Label symbols 7
1Introduction9
A company dedicated to patients 10 How to use this manual 11 Patient guides 13 Patient identification card 14
2 Important therapy information 15
Purpose of the neurostimulation system (indications) 16
Therapies that may not be used with the neurostimulation system (contraindications) 16
Risks and benefits 17
Risks of surgery 17 Possible adverse effects 18 Changes in therapy 18 Possible system complications 18
Warnings 19 Precautions 26
System and therapy 26
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Patient activities 29
Individualization of treatment 31
3 Introduction to stimulation 33
How stimulation works 34 Parts of your system 36 Understanding your therapy 38 Controlling your stimulation 40
What your clinician controls 40 What you control 40
Recovery and care 41
Recovering from surgery 41 Activities 41 When to call your clinician 43 Care schedule 44
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4 Using your patient programmer 45
How the patient programmer works 46 Synchronizing and displaying the THERAPY
screen 48 Guidelines for adjusting your stimulation 53 Turning your neurostimulator ON or
Contents
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OFF 55
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Adjusting stimulation settings 57
Using the NAVIGATOR key 58 Changing a group 59 Increasing or decreasing a parameter
(amplitude, pulse width, or rate) 62
Patient programmer batteries 66
Checking patient programmer batteries 66
Replacing patient programmer batteries 68
Summary of keys 69 Preferences: Changing the audio, contrast,
and number format 72 Using the carrying case and labeling the
patient programmer 75 Optional detachable antenna 76
Connecting the antenna 76 Using the antenna 78
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5 Troubleshooting 79
Programmer screens 80
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Warning screens 80 Communication screen 82
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Information screens 83
Possible problems and solutions 88 User assistance 95
6 Maintenance 97
Cleaning and care 98 Safety and technical checks 100 Battery and programmer disposal 101 Neurostimulator disposal 101 Declaration of conformity 102 Specifications 103
7 Appendix A: Electromagnetic
interference (EMI) 105
Contraindication 106 Warnings 108 Precautions 116 Notes 120
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Glossary 123
Index 129
Contents
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Label symbols
Explanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply.
CE
0123
System meets the applicable Canadian [C22.2-601.1-M90 (R2001)] and US (UL 60601-1:2003) electrical safety standard requirements.
Caution, consult accompanying
w
documents
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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.
The use of this device might be subject to individual country licensing regimes in Europe.
n
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Serial number
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Storage temperature
Relative humidity
Atmospheric pressure
IEC 60601-1/EN60601-1, Type BF
y
Equipment
Non-ionizing electromagnetic radiation
L
Screen light
Antenna jack
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c For USA audience only
The Medtronic Model 7439 Patient Programmer is designed to program the adjustable settings of the Medtronic Model 7479 Synergy Plus+ and Model 7479B Synergy Compact+ neurostimulators.
Label symbols
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1 Introduction

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A company dedicated to patients

Medtronic was founded in 1949 by Earl Bakken, a graduate student in electrical engineering, and his brother­in-law, Palmer J. Hermundslie. Today Medtronic is the world leader in medical technology, pioneering therapies that restore health, extend life and alleviate pain.
From its modest beginnings in a 55-square meter (600-square-foot) Minneapolis garage, we have transformed Medtronic into a worldwide company that serves customers in more than 120 countries. Each year, millions of patients are treated with Medtronic products and therapies. We invest almost $500 million each year in research and development, working closely with the world’s leading physicians and scientists to enhance our current products and therapies, and to
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develop new ones. Although we are a large company, individual patients and their needs are still the driving force behind what we do and how we do it.
Our goal is to improve the quality of your life. This booklet, which provides information about your neurostimulation system, is one small way we try to help.
Welcome to the Medtronic family. We wish you well.

How to use this manual

Use this manual after receiving an implanted neurostimulator. Ask your clinician to explain anything that is unclear.
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Chapter 1, “Introduction,” describes the
patient documents your clinician should have provided to you.
Chapter 2, “Important therapy information,” describes when you should and should not use a neurostimulation
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system, and the risks, benefits, warnings, precautions, and patient activities related to your neurostimulation system.
Chapter 3, “Introduction to stimulation,” describes the therapy, neurostimulation system components, and recovery and care information.
Chapter 4, “Using your patient programmer,” describes the patient programmer and how to perform specific tasks.
Chapter 5, “Troubleshooting,” describes patient programmer warning and information screens, how to solve possible problems, and who to contact if your device is lost or broken.
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Chapter 6, “Maintenance,” describes how
to care for your patient programmer and system specifications.
Appendix A provides more information about electromagnetic interference.
A glossary is included at the end of this
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Patient guides

You should receive the following documents after a neurostimulator is implanted.
Medtronic Model 7439 Patient
Programmer Quick Reference Guide:
provides instructions for common patient programmer tasks.
The Patient Identification Card: provides information about you, your neurostimulator, and your doctor.
Medtronic Model 7439 Patient Programmer Pain Therapy User Manual.
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Patient identification card

When you leave the hospital, your doctor will give you a patient identification card. This card supplies information about you, your implanted device, and your doctor. Your identification card may allow you to bypass security devices. Carry this card with you at all times. If you move, change doctors, or lose your card, contact Medtronic for a replacement card. Refer to the Medtronic contacts at the end of this manual.
c A temporary identification card will be provided at the hospital. After Medtronic receives your implant registration from the hospital, you will receive a permanent identification card.
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Introduction 1
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2 Important therapy
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Purpose of the neurostimulation system (indications)

Refer to the indications sheet that is packaged with the patient programmer for the purpose of the neurostimulation system and related information.
Therapies that may not be used with the neurostimulation system
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(contraindications)
Diathermy – Inform anyone treating you that you CANNOT have any shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) anywhere on your body because you have an implanted neurostimulation system. Energy from diathermy can be
Important therapy information 2
transferred through your implanted system,
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and can cause tissue damage, resulting in severe injury or death. Refer to “Appendix A: Electromagnetic interference (EMI)” on page 105 for more information.

Risks and benefits

Stimulation has helped thousands of patients manage their pain and improve their quality of life. Your neurostimulation system may be used with other pain treatments. Stimulation will not cure your pain. It can, however, reduce your pain to a tolerable level and allow you to resume many of your daily activities.
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Risks of surgery

Implanting a neurostimulation system has risks similar to spinal procedures, including spinal fluid leak, headaches, swelling, bruising, bleeding, infection, or paralysis.
If you are on anticoagulation therapy you might be at greater risk for postoperative
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complications such as hematomas that could result in paralysis.

Possible adverse effects

Adverse effects of stimulation are usually mild and go away when stimulation is turned OFF. These adverse effects could include radicular chest wall stimulation, uncomfortable stimulation, a jolting or shocking sensation, or persistent pain at the neurostimulator site.

Changes in therapy

Over time there could be changes in the level of your symptom control. In most cases your doctor can correct these changes without surgery.
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Possible system complications

The lead, extension, or neurostimulator could migrate within the body or erode through the skin. There could be undesirable changes in stimulation, possibly related to cellular
Important therapy information 2
changes around the electrode(s), changes in
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the position of the electrode(s), loose electrical connections, or lead or extension fractures. It is also possible that the implanted materials could cause an allergic or immune system response.
Your neurostimulation system might unexpectedly cease to function due to battery depletion or other causes. These events, which can include electrical shorts or open circuits, conductor (wire) fractures, and insulation breaches, cannot be predicted.

Warnings

Electromagnetic interference (EMI) –
Electromagnetic interference is a field of energy generated by equipment found in the home, work, medical or public environments that is strong enough to interfere with neurostimulator function. Neurostimulators include features that provide protection from EMI. Most electrical devices and magnets encountered in a normal day are unlikely to affect the operation of a neurostimulator.
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However, strong sources of EMI can result in the following:
Serious patient injury or death, resulting from heating of the implanted components of the neurostimulation system and damage to surrounding tissue.
System damage, resulting in a loss of or change in symptom control and requiring additional surgery.
Operational changes to the neurostimulator that can cause it to turn ON or OFF (particularly in a neurostimulator enabled for magnet use) or to reset to the power-on-reset (POR) values, resulting in loss of stimulation, return of underlying symptoms, and in the case of POR, requiring your health care provider to reprogram your neurostimulator.
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Unexpected changes in stimulation,
causing a momentary increase in stimulation or intermittent stimulation,
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jolting or shocking sensation. Although the unexpected change in stimulation could feel uncomfortable, it does not damage the device or injure a patient directly. In rare cases, as a result of the unexpected changes in stimulation, patients have fallen down and been injured.
Refer to Table 2.1, on page 22, and “Appendix A: Electromagnetic interference (EMI)” on page 105 for information on the sources of EMI, the effect of EMI on you and your neurostimulation system, and instructions on how to reduce the risk from EMI.
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See
guidelines
stimulation
Intermittent
ON
turns
Device
OFF or
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Table 2. 1 Potential effects of EMI from devices or procedures
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in
increase
Momentary
Device
damage
patient
Serious
Device/procedure
✓✓ ✓page 117
stimulation
✓✓ page 116
injury
Bone growth stimulators
✓✓ ✓ page 108
Defibrillation/
cardioversion
page 116
Dental drills and probes
✓✓ page 106
✓✓ page 109
Diathermy, therapeutic
Electrocautery
Printing instructions:
✓✓ page 116
Electrolysis
Electromagnetic field
devices (eg, arc
welding, power stations)
page 111
High-output ultrasonics
/lithotripsy
✓✓ page 120
Household items
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See
guidelines
stimulation
Intermittent
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Device
Momentary
Table 2 . 1 Potential effects of EMI from devices or procedures (continued)
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ON
turns
OFF or
in
increase
stimulation
Device
damage
injury
patient
Serious
Device/procedure
page 122
✓✓ ✓page 114
page 118
Laser procedures
✓✓ ✓ ✓ ✓page 111
Magnetic resonance
✓✓✓✓page 119
page 119
✓✓ page 113
imaging (MRI)
Psychotherapeutic
procedures
Radiation therapy
Radiofrequency (RF)/
microwave ablation
Therapeutic magnets
Theft detectors/security
devices
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See
guidelines
stimulation
Intermittent
ON
turns
Device
OFF or
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Momentary
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Table 2 . 1 Potential effects of EMI from devices or procedures (continued)
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in
increase
stimulation
Device
damage
injury
patient
Serious
Device/procedure
✓✓ page 106
Therapeutic ultrasound
✓✓ page 119
Transcutaneous
electrical nerve
stimulation (TENS)
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Case damage – If the neurostimulator case is ruptured or pierced due to outside forces, severe burns could result from exposure to the battery chemicals.
Neurostimulator interaction with cardiac implantable devices – When a
neurostimulator and an implanted cardiac device (eg, pacemaker, defibrillator) are required, the doctors involved with both devices (neurologist, neurosurgeon, cardiologist, cardiac surgeon) should discuss the possible interaction between the devices before surgery. To minimize or prevent device damage or interactions, your doctors should place the devices on the opposite side of the body from one another.
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Defibrillation therapy from the implanted
defibrillator can damage the neurostimulator.
The electrical pulses from the neurostimulation system could affect the sensing operation of the cardiac device and result in inappropriate responses from the cardiac device. Your doctor
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should reprogram your neurostimulator to a bipolar configuration and a minimum rate of 60 Hz. The cardiac device should be programmed to bipolar sensing.

Precautions

System and therapy

Clinician programmer interaction with a cochlear implant – If you have a cochlear
implant, the external portion of the cochlear system should be kept as far away as possible from the clinician programmer or the cochlear implant should be turned OFF during programming to prevent unintended audible clicks.
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Clinician programmer interaction with other active implanted devices – If you
have a neurostimulator and another active implanted device, the radio-frequency signal used to program either device can reset or reprogram the other device, or the magnet in a cardiac programmer can activate magnetically controlled functions in the
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neurostimulator. To verify that inadvertent programming did not occur, clinicians familiar with each device should check the programmed settings before you are sent home from the hospital and after either device is programmed (or as soon as possible after these times).
Contact your doctor immediately if you notice symptoms that could be related to either device or to the medical condition treated by that device.
Component compatibility – For proper therapy, only components that are compatible with the appropriate indication (eg, spinal cord stimulation) should be used. For a list of Medtronic-compatible components, ask your doctor. No claims of safety or efficacy are made about the compatibility of non-Medtronic components with Medtronic components.
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Patient control devices – Do not place
patient control devices (eg, patient programmer) over another device (eg,
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pacemaker, defibrillator, another neurostimulator). The patient control device could accidently change the operation of another device.
Patient device handling – To avo i d damaging the device, do not immerse it in liquid; do not clean it with bleach, nail polish remover, mineral oil, or similar substances; and do not drop it or mishandle it in a way that may damage it.
Patient device use – When operating an external neurostimulator, patient programmer, or charging system use special care near flammable or explosive atmospheres. An interaction between the flammable or explosive atmospheres and the battery in the device could occur. The consequences of using a battery-powered device near flammable or explosive atmospheres are unknown.
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Patient activities

Activities requiring excessive twisting or stretching – Avoid activities that put undue
stress on the implanted components of your neurostimulation system. Activities that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching can cause parts of your neurostimulation system to fracture or migrate. This can result in a loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery. Spinal cord stimulation patients in particular should avoid excessive bending of the torso.
Component manipulation – Do not manipulate or rub your neurostimulation system through the skin, sometimes called “Twiddler’s Syndrome.” Manipulation can cause damage to your system, skin erosion, or stimulation at the implant site.
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