Medtronic 37741 Patient Programmer User Manual 37742

Medtronic, Inc. Patient Programmer 37742

Contents

37742 Users Manual

Neurological Medtronic Confidential Title Model 37742 Patient programmer: pain therapy user manual Medtronic Confidential 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. Writer Theresa King-Hunter Date 13 October 2004 Part No. Part No. Rev Comments 220907005 B Market release DO NOT PRINT THIS FORM WHEN PRINTING THE LITERATURE PIECE. DO NOT COUNT THIS FORM IN THE LITERATURE PIECE PAGE COUNT. REVISION HISTORY: SEE PDM WEBSITE FOR INFORMATION. Page 1 Form MEDN-0043 version 6.0 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 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): 156 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.
37742_FC.fm 10/13/04 10:16 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00PATIENT PROGRAMMER 37742Pain therapy user manual Rx only2005
37742_FC.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00Medtronic®, Restore™, and SoftStart™ are trademarks of Medtronic, Inc.c FCC InformationThe following is communications regulation information on the Model 37741 Patient Programmer.FCC ID: LF537741This 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.
Printing instructions: 37742TOC.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR003ContentsLabel symbols 91Introduction11A company dedicated to patients 12How to use this manual 13Patient guides 15Patient identification card 172 Important therapy information 19Purpose of the device 20Purpose of the neurostimulation system (indications) 20Therapies that may not be used with the neurostimulation system (contraindications) 20Risks and benefits 21Risks of surgery 21Possible adverse effects 22Changes in therapy 22Possible system complications 22
220907005 Rev X37742TOC.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Contents4Warnings 23Precautions 30System and therapy 30Patient activities 32Individualization of treatment 353 Introduction to stimulation 37How stimulation works 38Parts of your system 40Understanding your therapy 43Controlling your stimulation 45What your clinician controls 45What you control 45Charging 46Recovery and care 48Recovering from surgery 48Activities 48When to call your clinician 50Care schedule 514 Using your patient programmer 53How the patient programmer works 54
Printing instructions: 37742TOC.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Contents5Synchronizing and displaying the THERAPY screen 55Checking the external neurostimulator battery 60Checking the implanted neurostimulator battery 61Guidelines for adjusting your stimulation 66Turning your neurostimulator ON or OFF 69Adjusting stimulation settings 70Using the NAVIGATOR key 71Changing a group 73Increasing or decreasing a parameter (amplitude, pulse width, or rate) 75Patient programmer batteries 79Checking patient programmer batteries 79Replacing patient programmer batteries 81Summary of keys 82Preferences: Changing the audio, contrast, time, and time/number format 85
220907005 Rev X37742TOC.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Contents6Using the carrying case and labeling the patient programmer 89Optional detachable antenna 91Connecting the antenna 91Using the antenna 935 Troubleshooting 95Programmer screens 96Warning screens 96Communication screens 100Information screens 100Possible problems and solutions 106User assistance 1126 Maintenance 113Cleaning and care 114Safety and technical checks 116Battery and programmer disposal 117Neurostimulator disposal 117Declaration of conformity 118Specifications 1197 Appendix A: Electromagnetic
Printing instructions: 37742TOC.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Contents7interference (EMI) 121Contraindication 122Warnings 124Precautions 132Notes 136Glossary 139Index 147
220907005 Rev X37742TOC.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Contents8
Printing instructions: 37742_Sym.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Label symbols9Label symbolsExplanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply.CE0123Conformité 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.System meets the applicable Canadian [C22.2-601.1-M90 (R2001)] and US (UL 60601-1:2003) electrical safety standard requirements.wCaution, consult accompanying documentsnSerial numberStorage temperature
220907005 Rev X37742_Sym.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Label symbols10Relative humidityAtmospheric pressureyIEC 60601-1/EN60601-1, Type BF EquipmentLNon-ionizing electromagnetic radiationScreen lightAntenna jackFor USA audiences only
37742_Ch01.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR001 Introduction
37742_Ch01.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00English 37742 2004-08Introduction 112A company dedicated to patientsMedtronic was founded in 1949 by Earl Bakken, a graduate student in electrical engineering, and his brother-in-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
Printing instructions: 37742_Ch01.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Introduction 113develop 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 manualUse this manual during test stimulation and after receiving an implanted neurostimulator. Ask your clinician to explain anything that is unclear.•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
220907005 Rev X37742_Ch01.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Introduction 114system, 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.•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 manual.
Printing instructions: 37742_Ch01.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Introduction 115Patient guidesTable 1.1 describes the documents you should receive during test stimulation and after a neurostimulator is implanted.Table 1.1 Patient guides for test stimulation and implantDocument Test(ENSa)Implant(INSb)Medtronic Model 37021 External Neurostimulator: Test Stimulation Patient Guide. Describes the goals, activities, components and instructions for test stimulation.✓Medtronic Model 37742 Patient Programmer: Pain Therapy User Manual. See page 13 for chapter details.✓✓Medtronic Model 37742 Patient Programmer: Quick Reference Guide. Provides instructions for common patient programmer tasks.✓✓
220907005 Rev X37742_Ch01.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Introduction 116Medtronic Model 37751 Recharger: Charging System User Manual. Describes the charging system and how to use it with an implanted neurostimulator.✓Medtronic Model 37751 Recharger: Charging System Quick Reference Guide. Provides instructions for common charging system tasks.✓Patient Identification Card. Provides information about you, your implanted neurostimulator, and your doctor.✓aExternal neurostimulatorbImplanted neurostimulatorTable 1.1 Patient guides for test stimulation and implant (continued)Document Test(ENSa)Implant(INSb)
Printing instructions: 37742_Ch01.fm 10/13/04 10:17 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Introduction 117Patient identification cardWhen 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. 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.
220907005 Rev X37742_Ch01.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Introduction 118
37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR002 Important therapy information
37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00English 37742 2004-08Important therapy information 220Purpose of the deviceThe Medtronic Model 37742 Patient Programmer is designed to program the Medtronic Model 37711 Restore Neurostimulator.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 (contraindications)Diathermy – Inform anyone treating you that you CANNOT have any shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as
Printing instructions: 37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Important therapy information 221diathermy) anywhere on your body because you have an implanted neurostimulation system. Energy from diathermy can be transferred through your implanted system, and can cause tissue damage, resulting in severe injury or death. Refer to “Appendix A: Electromagnetic interference (EMI)” on page 121 for more information.Risks and benefitsStimulation 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.Risks of surgeryImplanting a neurostimulation system has risks similar to spinal procedures, including spinal fluid leak, headaches, swelling, bruising, bleeding, infection, or paralysis.
220907005 Rev X37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Important therapy information 222If you are on anticoagulation therapy you might be at greater risk for postoperative complications such as hematomas that could result in paralysis.Possible adverse effectsAdverse 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 therapyOver time there could be changes in the level of your symptom control. In most cases your doctor can correct these changes without surgery.Possible system complicationsThe lead, extension, or neurostimulator could migrate within the body or erode through the skin. There could be undesirable changes in
Printing instructions: 37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Important therapy information 223stimulation, possibly related to cellular changes around the electrode(s), changes in 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.WarningsElectromagnetic 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
220907005 Rev X37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Important therapy information 224affect the operation of a neurostimulator. 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.•Unexpected changes in stimulation, causing a momentary increase in stimulation or intermittent stimulation,
Printing instructions: 37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Important therapy information 225which some patients have described as a 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 26, and “Appendix A: Electromagnetic interference (EMI)” on page 121 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.
37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00English 37742 2004-08Important therapy information 226Table 2.1 Potential effects of EMI from devices or proceduresDevice/procedureSerious patient injuryDevice damageMomentary increase in stimulationDevice turns OFF or ONIntermittent stimulationSee guidelinesBone growth stimulators ✓✓ ✓page 132Defibrillation/cardioversion✓✓ ✓ ✓page 124Dental drills and probes ✓page 132Diathermy, therapeutic ✓✓ ✓page 122Electrocautery ✓✓ page 125Electrolysis ✓✓ page 132Electromagnetic field devices (eg, arc welding, power stations)✓✓ ✓page 133High-output ultrasonics /lithotripsy✓page 127Household items ✓✓ page 136
37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR0037742 2004-08 EnglishImportant therapy information 227Laser procedures ✓page 134Magnetic resonance imaging (MRI)✓✓ ✓ ✓ ✓page 127Psychotherapeutic procedures✓✓✓✓page 135Radiation therapy ✓page 135Radiofrequency (RF)/microwave ablation✓✓ ✓page 129Therapeutic magnets ✓page 138Theft detectors/security devices✓✓ ✓page 130Table 2.1 Potential effects of EMI from devices or procedures (continued)Device/procedureSerious patient injuryDevice damageMomentary increase in stimulationDevice turns OFF or ONIntermittent stimulationSee guidelines
37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00English 37742 2004-08Important therapy information 228Therapeutic ultrasound ✓✓ ✓page 122Transcutaneous electrical nerve stimulation (TENS)✓✓ page 135Table 2.1 Potential effects of EMI from devices or procedures (continued)Device/procedureSerious patient injuryDevice damageMomentary increase in stimulationDevice turns OFF or ONIntermittent stimulationSee guidelines
Printing instructions: 37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Important therapy information 229Case 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.•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
220907005 Rev X37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Important therapy information 230should reprogram your neurostimulator to a bipolar configuration and a minimum rate of 60 Hz. The cardiac device should be programmed to bipolar sensing.PrecautionsSystem and therapyClinician 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.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
Printing instructions: 37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Important therapy information 231neurostimulator. 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, use only Medtronic Neurological components that are prescribed by your physician.Patient control devices – Do not place patient control devices (eg, patient programmer) over another device (eg, pacemaker, defibrillator, another neurostimulator). The patient control device could accidently change the operation of another device.
220907005 Rev X37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Important therapy information 232Patient device handling – To avoid 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.Patient activitiesActivities 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
Printing instructions: 37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Important therapy information 233can 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; this is sometimes called “Twiddler’s Syndrome.” Manipulation can cause damage to your system, lead dislodgement, skin erosion, or stimulation at the implant site. Manipulation may also flip your device so that it can’t be charged.
220907005 Rev X37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Important therapy information 234Scuba diving or hyperbaric chambers –Do not dive below 10 meters (33 feet) of water or enter hyperbaric chambers above 2.0 atmospheres absolute (ATA). Pressures below 10 meters (33 feet) of water or above 2.0 ATA can damage the neurostimulation system. Before diving or using a hyperbaric chamber, discuss the effects of high pressure with your doctor.Skydiving, skiing, or hiking in the mountains – High altitudes should not affect the neurostimulator; however, you should consider the movements involved in any planned activity and take care to not put undue stress on your implanted neurostimulation system. During skydiving, the sudden jerking that occurs when the parachute opens can dislodge or fracture the lead, requiring additional surgery to repair or replace the lead.Unexpected changes in stimulation –Electromagnetic interference, changes in posture, and other activities can cause a perceived increase in stimulation, which
Printing instructions: 37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Important therapy information 235some patients have described as uncomfortable stimulation (a jolting or shocking sensation). You should reduce your amplitude to the lowest setting and turn OFF your neurostimulator before engaging in activities that could become unsafe for you or others if you received an unexpected jolt or shock (eg, driving, operating power tools). Discuss these activities with your doctor.Individualization of treatmentPatient management – Best results are achieved when you are fully informed about the therapy risks and benefits, surgical procedure, follow-up requirements, and self-care responsibilities. Maximum benefits from the neurostimulation system require long-term postsurgical management.Patient selection – The neurostimulation system should not be implanted if: •your symptoms are not of physiological origin.
220907005 Rev X37742_Ch02.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Important therapy information 236•you are not an appropriate candidate for surgery.•you cannot properly operate the system.•you do not receive satisfactory results from test stimulation.Use in specific populations – The safety and effectiveness of this therapy has not been established for the following:•Pregnancy, unborn fetus, or delivery•Pediatric use (patients under the age of 18)
37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR003 Introduction to stimulation
37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: English 37742 2004-08Introduction to stimulation 338Medtronic ConfidentialNeuroPatntR00How stimulation worksNerve signals from all over your body travel to your spinal cord and then to your brain. Your brain translates the signals into sensations such as pain. Stimulation delivers electrical pulses to the area where your pain signals will be blocked as they move to the brain (Figure 3.1). Figure 3.1 Stimulation blocks some of the pain signals as they move to the brain.Neurostimulator pulses sent to brain Signalfrom foot Braintranslatessignal as painBrain senses pain and tingling
Printing instructions: 37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Introduction to stimulation 339Note: Stimulation will not cure your pain, nor will it block sharp pain caused by a recent injury.To most patients, the pulses feel like a steady, tingling sensation in the painful area (Figure 3.2).Figure 3.2 Stimulation feels like tingling in the area of pain.Generally, people experience a fairly constant sensation of stimulation. However, you may feel changes when you suddenly move or change position. Area of stimulation Area of pain
220907005 Rev X37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Introduction to stimulation 340Parts of your systemA typical neurostimulation system has implanted parts that deliver the electrical pulses to the area where your pain signals are blocked. Typically the implanted parts are: a neurostimulator, one or two leads, and one or two extensions (optional) (Figure 3.3). Figure 3.3 Implanted parts of a typical neurostimulation system. A typical neurostimulation system also includes external parts for controlling your system: a patient programmer and a charging system (Figure 3.4).ExtensionsLeadsElectrodesNeurostimulator
Printing instructions: 37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Introduction to stimulation 341Figure 3.4 External parts of a typical neurostimulation system.Neurostimulator – The neurostimulator is the power source for your neurostimulation system. It contains electronics that generate the electrical pulses. During test stimulation, an external neurostimulator is used to determine whether an implanted neurostimulator is the right choice for you. The implanted Restore neurostimulator contains a rechargeable battery. Carrying caseDetachable antenna (optional)Patient programmer Charging system
220907005 Rev X37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Introduction to stimulation 342Lead(s) – A lead is a thin wire covered with a protective coating. A lead has small metal electrodes near the tip. The electrodes transmit electrical pulses to the area where your pain signals are blocked. Extension(s) – An extension is a thin wire, covered with a protective coating, that connects the neurostimulator to a lead. Patient programmer – A patient programmer is a hand-held device that you use to select and adjust your stimulation. A detachable antenna is also available if you have difficulty reaching the neurostimulator implant site. Charging system – The charging system is used to charge the implanted neurostimulator battery.
Printing instructions: 37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Introduction to stimulation 343Understanding your therapyStimulation delivers electrical pulses to the area where your pain signals will be blocked as they travel to the brain. The electrical pulses are made up of parameters called amplitude, pulse width, and rate. •Amplitude is the strength of the pulse. It affects the stimulation strength or coverage required to manage your pain.•Pulse width is the duration of the pulse. It affects the stimulation strength or coverage required to manage your pain.•Rate is the number of pulses delivered per second. Rate feels like “tapping.”A program delivers electrical pulses to a specified pain site. Programs are combined into “groups” to provide stimulation to one or more pain sites. A menu of groups can be designed to meet a patient’s specific needs. Typically, each group is designed for particular activities, symptoms, or time of day.
220907005 Rev X37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Introduction to stimulation 344For example, Alex has pain in his low back and right thigh. Typically, Alex’s pain doesn’t vary; however, sometimes Alex has additional pain in his right ankle. Alex’s clinician designed two groups for Alex to choose from. Group A is for Alex’s typical pain; group B is for the additional ankle pain (Figure 3.5). Alex chooses whichever group he requires. Figure 3.5 Example of programs and groups.Group ALow back and thigh painGroup BLow back, thigh and ankle painProgram 1Program 2Program 3Program 1Program 2
Printing instructions: 37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Introduction to stimulation 345Controlling your stimulationYour neurostimulator only accepts programming from the clinician programmer or patient programmer; other devices are not able to program your neurostimulator.What your clinician controlsYour clinician uses a clinician programmer to communicate with your neurostimulator. Your clinician designs programs and groups according to your needs. Your clinician can also specify the settings that you will be able to adjust with your patient programmer. Discuss this with your clinician.What you controlAs your activities vary throughout the day, your therapy needs may change. The patient programmer allows you to turn stimulation ON and OFF, switch from one group to another, and adjust the amplitude, pulse width, or rate for each program in the active
220907005 Rev X37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Introduction to stimulation 346group. Talk to your clinician about the settings that apply to your therapy.ChargingIt is critical that you charge your neurostimulator battery before the battery is overdischarged. Refer to the manual packaged with the charging system for more information. Caution: Charge the neurostimulator when you see a low battery ( ) screen on the patient programmer or recharger; this prevents the battery from overdischarging (see glossary). If the neurostimulator battery is allowed to overdischarge, charging is not possible; however, the clinician may be able to restore the battery function.Allowing the neurostimulator battery to overdischarge will permanently affect the neurostimulator in one of the following ways:
Printing instructions: 37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Introduction to stimulation 347•Battery function is restored; however, charging sessions may be more frequent because battery capacity has been reduced.•Battery function is not restored and the neurostimulator must be surgically replaced. Battery function is not restored because:–The neurostimulator battery is permanently damaged. –The neurostimulator battery has been overdischarged and restored twice before. The third time the battery is overdischarged, the neurostimulator will reach end of service. Surgery is required to replace the neurostimulator.
220907005 Rev X37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Introduction to stimulation 348Recovery and careRecovering from surgeryIt takes several weeks to heal from surgery. It is normal to feel some discomfort from the incision(s) and to have some pain at the implant site for 2 to 6 weeks.Your doctor may also prescribe physical therapy or medication to help manage your pain. Always follow your doctor’s instructions.ActivitiesSome movements can cause changes in stimulation. For example, leaning back may cause the lead to move closer to your spinal cord; this can increase the sensation of stimulation. Other movements may cause the lead to move further away from your spinal cord and decrease the stimulation sensation. Sudden changes in stimulation are most common during recovery.
Printing instructions: 37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Introduction to stimulation 349•Avoid activities where you must bend, stretch, or twist your body; these movements can move your leads which affects your stimulation. •Avoid lying on your stomach.•Avoid reaching over your head.•Avoid turning from side to side.•Avoid bending forward, backward, or from side to side.•Avoid lifting more than 2 kilograms (5 pounds).As you begin to feel better, you should be able to perform activities such as:•Bathing or showering•Sexual activity•Working at home or at your business•Hobbies or activities, such as walking, gardening, cycling, or swimming•Traveling
220907005 Rev X37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Introduction to stimulation 350Remember, returning to your daily activities should make you feel better, not worse. Note: As you adjust to life with better pain management, you may want to try activities that you could not perform before your surgery. Discuss your activity level with your doctor.When to call your clinicianContact your clinician if any of the following events occur:•You have pain, redness, or swelling at the incision(s) later than 6 weeks after surgery.•You feel discomfort or pain during stimulation. Turn your neurostimulator OFF and call your doctor.•Your system is not working properly.•You cannot turn the neurostimulator ON or OFF.•You cannot adjust stimulation using your patient programmer.
Printing instructions: 37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Introduction to stimulation 351Care scheduleYour clinician will schedule follow-up visits to make sure you are receiving the most appropriate therapy.
220907005 Rev X37742_Ch03.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Introduction to stimulation 352
37742_Ch04.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR004 Using your patient programmer
37742_Ch04.fm 10/13/04 10:18 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00English 37742 2004-08Using your patient programmer 454How the patient programmer worksThe patient programmer communicates with your neurostimulator by sending signals to and receiving signals from the neurostimulator. To send and receive the signals, the internal antenna of the programmer must be placed over the neurostimulator (Figure 4.1).Notes:•The internal antenna is on the back of the programmer.•The programmer screen must face outward.•A detachable antenna is available for patients who have difficulty reaching their neurostimulator (refer to page 91).
Printing instructions: 37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 455Figure 4.1 Place the patient programmer over the neurostimulator.The patient programmer is used to: •turn the neurostimulator ON or OFF.•change stimulation settings.Synchronizing and displaying the THERAPY screenSynchronizing sends the settings from your neurostimulator to the patient programmer. All communication with the neurostimulator begins with synchronization.Internal antennaNeurostimulatorPatient programmer
220907005 Rev X37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 456•To synchronize your neurostimulator and the patient programmer, hold the programmer over your neurostimulator and press one of the three keys shown in Figure 4.2.Note: Using the NEUROSTIMULATOR ON key to synchronize also turns On the neurostimulator. Using the NEUROSTIMULATOR OFF key to synchronize also turns Off the neurostimulator.Figure 4.2 Synchronizing your neurostimulator and patient programmer.After synchronizing, the THERAPY screen appears (Figure 4.3). NEUROSTIMULATOR ONNEUROSTIMULATOR OFFSYNC
Printing instructions: 37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 457Figure 4.3 THERAPY screen.Icons on the THERAPY screen indicate your neurostimulator settings and the battery level of your neurostimulator and patient programmer (Table 4.1).Status rowGroup rowParameter row
220907005 Rev X37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 458Table 4.1 THERAPY screen iconsRow Icons DescriptionStatus Neurostimulator is ON(Implanted or external neurostimulator)Neurostimulator is OFF(Implanted or external neurostimulator)Implanted neurostimulator battery charge levelExternal neurostimulator battery levelProgrammer battery levelGroupaActiveNot activeGroup name
Printing instructions: 37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 459If your clinician programmed therapy to occur at a specific time, the scheduled therapy ( ) icon is shown in the Group row (Figure 4.4). Your clinician may also schedule a time for stimulation to be stopped (eg, when you sleep). Note: Whether scheduled therapy is active or stopped, you can turn stimulation ON or OFF.An example of scheduled therapy is provided in Figure 4.4 The screens and timetable display the following:ParameterbAmplitudePulse widthRateaIf only one group is available, this row is blank.bIf you cannot change any parameters, this row is blank.Table 4.1 THERAPY screen icons (continued) Row Icons Description
220907005 Rev X37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 460•Group B is active most of the day and stimulation is ON•Stimulation is stopped during sleepFigure 4.4 Example of scheduled therapy.Checking the external neurostimulator batteryCheck the external neurostimulator battery level every day. •To check the external neurostimulator battery level, hold the patient programmer over your neurostimulator and press the SYNC key. The THERAPY screen appears displaying the external neurostimulator battery level (Figure 4.5).Stimulation is stoppedGroup B is active
Printing instructions: 37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 461Figure 4.5 External neurostimulator battery status on the THERAPY screen.When the batteries are low, replace the batteries as described in the external neurostimulator patient guide.Screens indicating that the external neurostimulator batteries need immediate replacement are described in Table 5.1 and Table 5. 3.Checking the implanted neurostimulator batteryCheck the implanted neurostimulator battery charge level every day.•To check the implanted neurostimulator battery charge level, hold the patient programmer over your neurostimulator Battery levelReplacebatteriesFull
220907005 Rev X37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 462with the screen facing outward and press the SYNC key. The THERAPY screen appears displaying the implanted neurostimulator battery level (Figure 4.6). Caution: Charge the neurostimulator when you see a low battery ( ) screen on the patient programmer or recharger; this prevents the battery from overdischarging (see glossary). If the neurostimulator battery is allowed to overdischarge, charging is not possible; however, the clinician may be able to restore the battery function.Allowing the neurostimulator battery to overdischarge will permanently affect the neurostimulator in one of the following ways:•Battery function is restored; however, charging sessions may be more frequent because battery capacity has been reduced.•Battery function is not restored and the neurostimulator must be surgically replaced. Battery function is not restored because:
Printing instructions: 37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 463–The neurostimulator battery is permanently damaged. –The neurostimulator battery has been overdischarged and restored twice before. The third time the battery is overdischarged, the neurostimulator will reach end of service. Surgery is required to replace the neurostimulator.Figure 4.6 Implanted neurostimulator charge level on the THERAPY screen.When the neurostimulator battery charge level is low, charge the battery as described in the manual packaged with the charging system. Your implanted neurostimulator battery can be charged many times; however, eventually the neurostimulator will need to be replaced.Battery charge levelChargeneurostimulatorFull
220907005 Rev X37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 464If the implanted neurostimulator needs immediate charging, you will see one of the screens shown on Table 4.2.Table 4.2 Neurostimulator battery screens The implanted neurostimulator battery charge level is low and stimulation will not be available soon.Charge your implanted neurostimulator battery. Refer to the manual packaged with the charging system.Press any arrow on the NAVIGATOR key to clear this message from the screen.The neurostimulator battery charge level is low and stimulation has stopped.Charge the neurostimulator battery now. Refer to the manual packaged with the charging system.
Printing instructions: 37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 465 Caution: Charge the neurostimulator when you see a low battery ( ) screen on the patient programmer or recharger; this prevents the battery from overdischarging (see glossary). If the neurostimulator battery is allowed to overdischarge, charging is not possible; however, the clinician may be able to restore the battery function.Allowing the neurostimulator battery to overdischarge will permanently affect the neurostimulator in one of the following ways:•Battery function is restored; however, charging sessions may be more frequent because battery capacity has been reduced.•Battery function is not restored and the neurostimulator must be surgically replaced. Battery function is not restored because:-The neurostimulator battery is permanently damaged. -The neurostimulator battery has been overdischarged and restored twice before. The third time the battery is overdischarged, the neurostimulator will reach end of service. Surgery is required to replace the neurostimulator.Table 4.2 Neurostimulator battery screens (continued)
220907005 Rev X37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 466Guidelines for adjusting your stimulationTo receive the most effective therapy, some days you may need to adjust your stimulation several times; other days you may not need to adjust it at all. Your clinician will provide complete guidelines about when you may want to adjust your stimulation. Table 4.3 provides general guidelines for adjusting your stimulation.
Printing instructions: 37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 467Table 4.3 Stimulation adjustmentguidelinesSituation ActionStimulation is too strong Decrease amplitude(s) or pulse width(s)Stimulation is not strong enough Increase amplitude(s) or pulse width(s)Stimulation covers too much area Decrease amplitude(s) or pulse width(s) or change to a different groupStimulation does not cover painful area Increase amplitude(s) or pulse width(s) or change to a different groupThe pulses (tapping sensations)feel too slowIncrease rateThe pulses (tapping sensations) feel too fastDecrease rate
220907005 Rev X37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 468You have unexpected changes in stimulation 1. Turn OFF the neurostimulator.2. Decrease amplitude(s), turn ON the neurostimulator, adjust parameters, and slowly increase amplitude(s) to the desired level. orChange to a different group and turn ON the neurostimulator.You have tried adjusting stimulation but are unable to find an effective setting.Contact your clinician.You will be passing through a theft detector or security device Before engaging in these activities, consult “Appendix A: Electromagnetic Interference (EMI),” for details.You will be using potentially dangerous equipmentYou will be having a medical procedureTable 4.3 Stimulation adjustmentguidelines (continued)Situation Action
Printing instructions: 37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 469Turning your neurostimulator ON or OFF1. Hold the programmer over your neurostimulator with the programmer screen facing outward and press the NEUROSTIMULATOR ON or NEUROSTIMULATOR OFF key (Figure 4.7). The THERAPY screen appears.2. Verify that the appropriate ON or OFF icon is displayed on the THERAPY screen (Figure 4.7).Figure 4.7 Turning your neurostimulator ON or OFF. Caution: To prevent possible uncomfortable or unexpected stimulation OFFON
220907005 Rev X37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 470(jolting or shocking sensation) when stimulation is turned ON, decrease all amplitudes to the lowest setting before adjusting the pulse width or rate and after turning OFF the neurostimulator.3. If you have turned the neurostimulator OFF, decrease the program amplitudes to the lowest setting. For instructions, see “Increasing or decreasing a parameter (amplitude, pulse width, or rate)” on page 75.Note: When you turn your neurostimulator ON or OFF, the patient programmer and neurostimulator are synchronized.Adjusting stimulation settingsThere is often more than one way to change stimulation settings. These instructions describe the most common ways.Notes: •Ask your clinician to print a report with your programmed settings.
Printing instructions: 37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 471•When a stimulation setting is changed, you will see the change on the THERAPY screen.•If audio is ON, you will hear one tone that means the change was effective. Three rapid tones mean the change did not occur.Using the NAVIGATOR keyThe NAVIGATOR key arrows move the selection box on the THERAPY screen (Figure 4.8).Figure 4.8 NAVIGATOR key.
220907005 Rev X37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 472•To move the selection box between rows press the up and down arrows on the NAVIGATOR key. •To move the selection box across a row that continues, press the left and right arrows on the NAVIGATOR key.•When moving the selection box with the NAVIGATOR key, you do not need to hold the programmer over your neurostimulator. However, you must hold the programmer over your neurostimulator when pressing all other keys except the power key.A row continues when the OPTIONS icon is displayed at the end of a row (Figure 4.9).Figure 4.9 The OPTIONS icon and selection box.Selection box Options icon
Printing instructions: 37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 473Changing a group1. Hold the patient programmer over your neurostimulator with the screen facing outward and press the SYNC key. The THERAPY screen appears.2. Press the up arrow on the NAVIGATOR key to move the selection box to the Group row (Figure 4.10).Figure 4.10 Group row.3. Press the left or right arrows on the NAVIGATOR key to move the selection box to the desired group (Figure 4.11). Caution: Select the group that your clinician has recommended for the current activity or posture. Use of another group may result in uncomfortable or unexpected stimulation (jolting or shocking sensation) when stimulation is turned ON.Group row
220907005 Rev X37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 474Figure 4.11 Move to a new group.4. Hold the programmer over your neurostimulator and press the SYNC key to send the change to your neurostimulator (Figure 4.12). 5. Verify that the new group is active on the THERAPY screen (Figure 4.12).Figure 4.12 Active group.
Printing instructions: 37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 475Increasing or decreasing a parameter (amplitude, pulse width, or rate)Notes:•To increase a parameter, the neurostimulator must be ON. •To decrease a parameter, the neurostimulator may be ON or OFF.1. Hold the patient programmer over your neurostimulator with the screen facing outward and press the NEUROSTIMULATOR ON , NEUROSTIMULATOR OFF , or SYNC key. The THERAPY screen appears. Caution: To prevent possible uncomfortable or unexpected stimulation (jolting or shocking sensation) when stimulation is turned ON, decrease all amplitudes to the lowest setting before adjusting the pulse width or rate and after turning OFF the neurostimulator.Note: To change a parameter, it must be in a group that is active .
220907005 Rev X37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 4762. Press the left or right arrow on the NAVIGATOR key to move the selection box to the desired parameter (Figure 4.13).Figure 4.13 Move to parameter row.Notes: –If there is more than one program, scroll to the right to display the amplitude ( ) for each program, followed by the pulse width ( ) for each program, and then the rate ( ). (Scrolling to the left reverses the order.)–The rate is the same for all programs within a group.3. Hold the programmer over your neurostimulator and press the INCREASE or DECREASE key as Parameter row
Printing instructions: 37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 477needed (Figure 4.14). The increase or decrease occurs immediately and is saved in the neurostimulator.Figure 4.14 DECREASE and INCREASE keys.Notes:–Pressing and holding the INCREASE or DECREASE key changes the value every half-second.–If one of the information screens in Table 4.4 is displayed, you tried to increase or decrease the value beyond the available limits programmed by your clinician. DECREASE INCREASE
220907005 Rev X37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 478Table 4.4 Parameter limit screensLower limitYou tried to decrease a parameter (amplitude, pulse width, or rate) below the lowest value allowed.Press any arrow on the Navigator key to clear the screen.Upper limitYou tried to increase a parameter (amplitude, pulse width, or rate) above the highest value allowed.Press any arrow on the Navigator key to clear the screen.
Printing instructions: 37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 479Patient programmer batteriesAlways keep two new AAA alkaline batteries available for replacement. New batteries provide about two months use, depending upon how often the programmer is used. Caution: If the device will not be used for several weeks, remove the batteries from the device. A battery left in the device may corrode, causing damage to the electronic components.Checking patient programmer batteriesThe patient programmer battery level is displayed on the THERAPY screen (Figure 4.15).•To check the programmer battery level, hold the patient programmer over your neurostimulator and press the SYNC key. The THERAPY screen appears displaying the programmer battery level (Figure 4.15).
220907005 Rev X37742_Ch04.fm 10/13/04 10:19 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 480Figure 4.15 Patient programmer battery level.If the programmer batteries need immediate replacement, one of the screens shown in Table 4.5 appears. Table 4.5 Patient programmer battery replacement screensThe patient programmer batteries are low. You can finish programming.Press any arrow on the Navigator key to clear the screen; then continue programming. Replace the programmer batteries before the batteries become depleted. The programmer batteries are depleted. Programming is not possible.Replace the programmer batteries now.ReplacebatteriesFullBattery level
Printing instructions: 37742_Ch04.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 481Replacing patient programmer batteries1. Open the battery compartment cover (Figure 4.16).Figure 4.16 Opening the battery cover.2. Remove the depleted batteries.3. Insert the new batteries as shown on the battery compartment label.4. Close the battery compartment cover.5. Dispose of old batteries according to local requirements.
220907005 Rev X37742_Ch04.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 482Summary of keysFigure 4.17 Patient programmer keys.DECREASE INCREASENEUROSTIMULATOR ONNEUROSTIMULATOR OFFSYNCNAVIGATORPOWER/ BACKLIGHT
Printing instructions: 37742_Ch04.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 483Table 4.6 Summary of keysKey FunctionTurns the neurostimulator ON or OFF .•The programmer must be held over the neurostimulator while pressing the NEUROSTIMULATOR ON or OFF key.•Pressing either of these keys also automatically synchronizes the neurostimulator and programmer and displays the THERAPY screen.Synchronizes the neurostimulator and programmer.Activates a selected group.The programmer must be held over the neurostimulator while pressing the SYNC key.ONOFF
220907005 Rev X37742_Ch04.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 484Decreases or increases a parameter.•The programmer must be held over the neurostimulator while pressing the INCREASE or DECREASE key.•Pressing and holding the INCREASE or DECREASE key changes the parameter every half-second.•To increase a parameter, the neurostimulator must be turned ON.Moves the selection box on the THERAPY screen.The OPTIONS icon at the end of a row on the THERAPY screen indicates that the row continues.Turns the patient programmer power ON and OFF.Pressing and holding this key also turns the backlight ON and OFF. The backlight provides more light to the display.Table 4.6 Summary of keys (continued)Key FunctionDecreaseIncrease
Printing instructions: 37742_Ch04.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 485Preferences: Changing the audio, contrast, time, and time/number formatProgrammer preferences are accessed from the Status row of the THERAPY screen. Table 4.7 lists the preference icons.1. Hold the patient programmer over your neurostimulator with the screen facing outward and press the SYNC key. The THERAPY screen appears.Table 4.7 Preference iconsIcons PreferenceAudioContrastTimeTime and number format
220907005 Rev X37742_Ch04.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 4862. Press the up arrow on the NAVIGATOR key to move the selection box to the Status row (Figure 4.18).Figure 4.18 Preferences are accessed from the Status row.3. Press the left or right arrow on the NAVIGATOR key to move the selection box to the desired preference (Figure 4.19).Figure 4.19 Move to desired preference.4. Press the down arrow to move the selection box to the Change row (Figure 4.20).Status rowDesired preference
Printing instructions: 37742_Ch04.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 487Figure 4.20 Move to Change row.5. Follow the steps in Table 4.8 to change the selected preference.Table 4.8 Changing preferencesAudio1. Press the left or right arrow on the NAVIGATOR key to move the selection box to audio ON or OFF . 2. Go to step 6, page 89.Contrast1. Press the left or right arrow on the NAVIGATOR key to make the contrast lighter or darker .2. Go to step 6, page 89.Change row
220907005 Rev X37742_Ch04.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 488Time 1. Press the left or right arrow on the NAVIGATOR key to move the selection box to the hour, minutes, or time of day (A or P). 2. Press the INCREASE or DECREASE key to change the selection. 3. Press the up arrow on the Navigator key to return the selection box to the Status row. 4. Press the left or right arrow on the NAVIGATOR key to return to the THERAPY screen.5. Press the SYNC key to send the change to your neurostimulator.6. To verify the time change, repeat steps 2 and 3 on page 86 to return to the time preference screen.Table 4.8 Changing preferences (continued)
Printing instructions: 37742_Ch04.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 4896. When the change is displayed on the screen, move the selection box to the Status (top) row. This saves the change in the patient programmer.7. Press the left or right arrow on the NAVIGATOR key to move to another preference or return to the THERAPY screen.Using the carrying case and labeling the patient programmerThe carrying case has a pouch to hold the patient programmer and the quick reference guide (Figure 4.21). Time and number format1. Press the left or right arrow on the NAVIGATOR key to move the selection box to a 12-hour clock and numbers with decimals or with a 24-hour clock and numbers with commas.2. Go to step 6, page 89.Table 4.8 Changing preferences (continued)3.50
220907005 Rev X37742_Ch04.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 490The case also has a loop on the back that attaches to a belt.Figure 4.21 Insert the programmer into the case.Place an identification label on the back of your patient programmer in case the programmer is lost (Figure 4.22).Figure 4.22 Place the adhesive label on the back of the programmer.ID label
Printing instructions: 37742_Ch04.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 491Optional detachable antennaThe detachable antenna is available if you have difficulty reaching the neurostimulator. It is also useful for viewing the patient programmer screen while you are adjusting stimulation. Connecting the antenna1. Place the antenna over your neurostimulator (Figure 4.23).Figure 4.23 Place the antenna over your neurostimulator.
220907005 Rev X37742_Ch04.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 4922. Pull the fabric of your clothing through the large opening in the antenna. Then, wedge the fabric in the narrow slit to secure the antenna in place (Figure 4.24). Figure 4.24 Pull the fabric through the slit (a) and wedge in place (b).3. Push the antenna plug firmly into the antenna jack ( ) on the patient programmer (Figure 4.25).ab
Printing instructions: 37742_Ch04.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your patient programmer 493Figure 4.25 Insert the antenna plug into the antenna jack.Using the antennaAfter the antenna is connected, follow the instructions for using the patient programmer.When you have finished using the patient programmer, grasp the antenna plug and pull it out. Caution: Do not pull directly on the antenna cable to disconnect the cable from the programmer because this may damage the antenna cable.
220907005 Rev X37742_Ch04.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Using your patient programmer 494
37742_Ch05.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR005 Troubleshooting
37742_Ch05.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00English 37742 2004-08Troubleshooting 596This chapter will help you solve problems with your programmer. It also provides information on when to call your clinician.Note: If you cannot solve a problem or if your problem is not described here, contact your clinician.Programmer screensThe programmer displays warning ( ), communication ( ), and information ( ) screens to provide you with information about your system, alert you to a problem with your system, or to guide you during programmer use.Warning screensWarning screens indicate a problem with the programmer, the antenna, or the neurostimulator. If the audio is ON, three tones alert you to the message. Table 5.1
Printing instructions: 37742_Ch05.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Troubleshooting 597describes warning screens and provides instructions (see blue text) on how to resolve the problem and clear the screen. Table 5.1 Warning screensScreen Cause and actionSynchronize programmer and neurostimulatorThe programmer and the neurostimulator must be synchronized.Synchronize the programmer and neurostimulator.Replace the external neurostimulator batteriesThe external neurostimulator batteries are depleted and stimulation is not available.Replace the external neurostimulator batteries now. Refer to the manual packaged with the external neurostimulator.Replace the programmer batteriesThe programmer batteries are depleted. Programming is not possible.Replace the programmer batteries now.
220907005 Rev X37742_Ch05.fm 10/13/04 10:20 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Troubleshooting 598Charge the implanted neurostimulator batteryThe neurostimulator battery charge level is low and stimulation has stopped.Charge the neurostimulator battery now. Refer to the manual packaged with the charging system. Caution: Charge the neurostimulator when you see a low battery ( ) screen on the patient programmer or recharger; this prevents the battery from overdischarging (see glossary). If the neurostimulator battery is allowed to overdischarge, charging is not possible; however, the clinician may be able to restore the battery function.Allowing the neurostimulator battery to overdischarge will permanently affect the neurostimulator in one of the following ways:•Battery function is restored; however, charging sessions may be more frequent because battery capacity has been reduced.•Battery function is not restored and the neurostimulator must be surgically replaced. Battery function is not restored because:Table 5.1 Warning screens (continued)Screen Cause and action
Printing instructions: 37742_Ch05.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Troubleshooting 599-The neurostimulator battery is permanently damaged. -The neurostimulator battery has been overdischarged and restored twice before. The third time the battery is overdischarged, the neurostimulator will reach end of service. Surgery is required to replace the neurostimulator.Call doctor The system is not working correctly. Stimulation may have stopped.Error codes 0 to 250: Remove batteries from the patient programmer, wait several seconds, then re-insert the batteries. If the error message appears again, call your doctor.Other codes: Write down the code shown on the screen. Call your doctor.Table 5.1 Warning screens (continued)Screen Cause and action
220907005 Rev X37742_Ch05.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Troubleshooting 5100Communication screensThe communication screens show you that a process is in progress. Table 5.2 describes the communication screens for your neurostimulation system.The communication screens automatically clear when the neurostimulation system finishes the process.IInformation screensThe information screens show the programming status and the battery level for Table 5.2 Communication screensScreen Description and actionCommunication The programmer is communicating with the implanted neurostimulator.Communication The programmer is communicating with the external neurostimulator.
Printing instructions: 37742_Ch05.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Troubleshooting 5101your programmer and neurostimulator. If the audio is ON, three tones alert you to the message. Table 5.3 describes information screens and instructions on how to proceed (see blue text).Note: Press any arrow on the NAVIGATOR key to clear an information screen.Table 5.3 Programmer information screensScreen Description and actionPoor communicationThe programmer attempted to communicate with the implanted neurostimulator, but communication was unsuccessful.Reposition the programmer over the implanted neurostimulator with the screen facing outward and try communication again.If using the detachable antenna, check that the antenna is connected properly, reposition the antenna and try communication again.
220907005 Rev X37742_Ch05.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Troubleshooting 5102Poor communicationThe programmer attempted to communicate with the external neurostimulator, but communication was unsuccessful.Reposition the programmer over the external neurostimulator with the programmer screen facing outward and try communication again.If using the detachable antenna, check that the antenna is connected properly, reposition the antenna and try communication again.Press NEUROSTIMULATOR ON keyYou tried increasing a parameter value with the neurostimulator OFF.Turn your neurostimulator ON and try communication again.Table 5.3 Programmer information screens (continued)Screen Description and action
Printing instructions: 37742_Ch05.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Troubleshooting 5103Upper limit (amplitude shown)You tried increasing a parameter (amplitude, pulse width, or rate) above the highest value allowed.External neurostimulator only: High stimulation settings may cause an upper limit message to appear when you have not exceeded your upper limit. If this situation occurs, replace the neurostimulator batteries.Lower limit (amplitude shown)You tried decreasing a parameter (amplitude, pulse width, or rate) below the lowest value allowed.Connect cable The cable to the external neurostimulator is loose or disconnected.Connect the cable to the external neurostimulator. Turn the programmer OFF then ON again.Table 5.3 Programmer information screens (continued)Screen Description and action
220907005 Rev X37742_Ch05.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Troubleshooting 5104Implanted neurostimulator battery charge level is lowThe implanted neurostimulator battery charge level is low and stimulation will not be available soon.Charge your implanted neurostimulator battery. Refer to the manual packaged with the charging system.External neurostimulator batteries are lowThe external neurostimulator batteries are low and stimulation will not be available soon.Replace the external neurostimulator batteries. Refer to the manual packaged with the external neurostimulator.Programmer batteries are lowThe patient programmer batteries are low. You can finish programming.Replace the programmer batteries before the batteries become depleted. Table 5.3 Programmer information screens (continued)Screen Description and action
Printing instructions: 37742_Ch05.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Troubleshooting 5105Sync up You tried increasing or decreasing a parameter for an inactive group.Synchronize the programmer and neurostimulator.Patient programmer informationThese screens provide information to your clinician or Medtronic during troubleshooting.Neurostimulation system informationCommunication informationTable 5.3 Programmer information screens (continued)Screen Description and action
220907005 Rev X37742_Ch05.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Troubleshooting 5106Possible problems and solutionsTable 5.4 will help you solve problems or identify when to call your clinician. Problems are described in the left column (bold black text). The right column lists possible causes of the problem (plain text) and how to correct the problem (bold blue text).Note: If a problem is not solved after several attempts, or if a problem is not described here, contact your clinician.
37742_Ch05.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR0037742 2004-08 EnglishTroubleshooting 5107Table 5.4 Troubleshooting problemsProblems Causes and actionsUncomfortable stimulation: You are too uncomfortable with the current stimulation to think about how to change it.The selected group or stimulation settings are not suitable for your current activity or posture.1. Turn the neurostimulator OFF.2. Reduce the amplitude and pulse width for each program in the active group.3. Reduce the rate for the active group.4. Change the group if the active group is not one that is recommended by your clinician for your current activity or posture; or adjust the amplitude, pulse width, and rate to values that provide adequate pain relief.
37742_Ch05.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00English 37742 2004-08Troubleshooting 5108Delayed stimulation changes: You do not feel stimulation right away after turning ON the neurostimulator or you feel stimulation after turning OFF the neurostimulator.Your clinician programmed SoftStart/Stop so that stimulation starts and stops gradually:Allow about 8 seconds for your neurostimulator to turn ON and OFF.You may feel a residual effect after the neurostimulator is turned OFF.Intermittent stimulation: You feel stimulation only some of the time.Your clinician may have programmed your neurostimulator to turn ON and OFF at regular intervals. However, if you are not receiving adequate pain relief, contact your clinician.Table 5.4 Troubleshooting problems (continued)Problems Causes and actions
37742_Ch05.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR0037742 2004-08 EnglishTroubleshooting 5109No stimulation: You do not feel stimulation but you think stimulation should be ON.Stimulation is OFF. Use your patient programmer to turn your neurostimulator ON.Your clinician has programmed scheduled therapy and stimulation is scheduled to be stopped at this time.If stimulation is desired, select another group and turn stimulation ON.The amplitudes for each program in the active group are set too low to feel. Use your patient programmer to increase the amplitude(s).Table 5.4 Troubleshooting problems (continued)Problems Causes and actions
37742_Ch05.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00English 37742 2004-08Troubleshooting 5110Patient programmer is unresponsive: The display screen is blank when you press a key.The programmer batteries are depleted.Replace the programmer batteries.The programmer batteries are in backwards.Check the battery polarity and reinstall the patient programmer batteries.Dropped programmer: Your patient programmer falls off a cabinet or table. The patient programmer is designed to withstand a short drop to a hard surface and still operate normally, even if the case is chipped or nicked.Try the patient programmer; it should work. Table 5.4 Troubleshooting problems (continued)Problems Causes and actions
37742_Ch05.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR0037742 2004-08 EnglishTroubleshooting 5111Fluid on the programmer: Fluid was spilled onto the programmer or the programmer was dropped into water.The patient programmer is not waterproof, and water can damage the device.Immediately remove the programmer from the water, then dry the programmer with a towel dampened with clean tap water.Remove the batteries, then allow the battery compartment to air dry at room temperature for 24 hours.Table 5.4 Troubleshooting problems (continued)Problems Causes and actions
220907005 Rev X37742_Ch05.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Troubleshooting 5112User assistanceThe patient programmer has been designed and tested to provide trouble-free service. If repair or service is needed, contact your clinician or a Medtronic sales office. Refer to the list of Medtronic contacts at the end of this manual. The serial number is located in the battery compartment. This number identifies each patient programmer. If you contact Medtronic about your patient programmer, refer to the serial number. If your programmer stops working – First try the steps in Table 5.4. Otherwise, contact your clinician.If you lose your programmer – Contact your clinician to order a new programmer.c To register the programmer for service covered by the warranty, complete and mail the warranty registration.
37742_Ch06.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR006 Maintenance
37742_Ch06.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00English 37742 2004-08Maintenance 6114This section describes how to care for and dispose of your patient programmer and accessories.Cleaning and careFollow these guidelines to ensure that the patient programmer and accessories function properly. Caution: If the device will not be used for several weeks, remove the batteries from the device. A battery left in the device may corrode, causing damage to the electronic components.•Keep the device out of the reach of children.•Use the device only as explained to you by your clinician or as discussed in this manual.
Printing instructions: 37742_Ch06.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Maintenance 6115•Follow all warnings and precautions in chapter 2 “Important therapy information” and chapter 7 “Appendix A: Electromagnetic interference (EMI)”.•Handle the device with care. Do not drop, strike, or step on the device.•Do not dismantle or tamper with the device.•Clean the outside of the device with a damp cloth when necessary. Mild household cleaners will not damage the device or labels.•The device is not waterproof. Do not allow moisture to get inside the device. •Keep fresh batteries available. •Replace low or depleted batteries.
220907005 Rev X37742_Ch06.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Maintenance 6116Safety and technical checksPeriodic safety and technical checks or periodic maintenance of the patient programmer are not required. The patient programmer contains no user-serviceable parts. If the patient programmer requires repair or is nonfunctional, send it to the address listed below.USAMedtronic, Inc.Neurological DivisionMSN600PO Box 1250Minneapolis, MN 55440-9087Europe, Africa, Middle East, and Asia-Pacific countriesMedtronic EOCMedical Equipment Service EuropeEarl Bakkenstraat 106422 P J HeerlenThe NetherlandsTel. 31-45566-4880 Fax 31-45566-8028
Printing instructions: 37742_Ch06.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Maintenance 6117Battery and programmer disposalDispose of depleted batteries and worn out devices according to local requirements. If you no longer need your programmer and would like to donate it, contact your clinician.Neurostimulator disposalThe implanted device should be removed before burial or cremation. In some countries, removal of battery-powered implantable devices is required before burial because of environmental concerns. Also, the device should be removed before cremation. The cremation process causes the battery to explode. Explanted devices should not be resterilized or reimplanted.
220907005 Rev X37742_Ch06.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Maintenance 6118Declaration of conformityMedtronic declares that this product is in conformity with the essential requirements of Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment, and Directive 90/385/EEC on Active Implantable Medical Devices.For additional information, contact Medtronic. Refer to the list of Medtronic contacts at the end of this manual.
Printing instructions: 37742_Ch06.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Maintenance 6119SpecificationsTable 6.1 Patient programmerspecificationsItem SpecificationPower source 2 AAA alkaline batteries (non-rechargeable, LR03)Operating temperature +9 to +43°C (+49 to +110°F)Storage temperature -40 to +65°C (-40 to +150°F)Operating/storage relative humidity 30% to 95%Operating/storage atmospheric pressure700 hPa to 1060 hPa(20.7 in. Hg to 31.3 in. Hg)Size Approximately 9.4 x 5.6 x 2.8 cm (3.7 x 2.2 x 1.1 inches)Weight, including batteries Approximately 111 g (3.9 oz.)Battery life 2 months (average) for alkaline batteriesMode of operation Continuous
220907005 Rev X37742_Ch06.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Maintenance 6120Table 6.2 Implanted neurostimulation system specificationsDescription SpecificationsTypical materials in contact with human tissueaNeurostimulator TitaniumPolyurethaneSilicone rubberPolysulfoneSilicone medical adhesiveLead PolyurethanePlatinum iridiumExtension PolyurethaneaFor a complete list of materials in contact with human tissue, contact your clinician.
37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR007 Appendix A: Electromagnetic interference (EMI)
37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00English 37742 2004-08Appendix A: Electromagnetic interference 122Please review “Electromagnetic interference (EMI)” on page 23 and Table 2.1 on page 26 for additional information.Before any medical procedure is begun, always inform any health care personnel that you have an implanted neurostimulation system. The potential for the following effects results from an interaction of the neurostimulation system and equipment — even when both are working properly.ContraindicationDiathermy – 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
Printing instructions: 37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 123diathermy can be transferred through your implanted system, can cause tissue damage, and can result in severe injury or death.Diathermy can also damage parts of your neurostimulation system. This can result in loss of therapy from your neurostimulation system, and can require additional surgery to remove or replace parts of your implanted system.Personal injury or device damage can occur during diathermy treatment when:•the neurostimulation system is turned ON or OFF.•diathermy is used anywhere on your body (not just where your neurostimulation system is located).•diathermy is used to deliver heat or no heat.•any component of your neurostimulation system (lead, extension, neurostimulator) remains in your body.
220907005 Rev X37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 124WarningsEMI from the following medical procedures or equipment can damage the device, interfere with device operation, or cause you harm. If these procedures or equipment are required, the guidelines below must be followed:Defibrillation / cardioversion – When you are in ventricular or atrial fibrillation, the first consideration is your survival. External defibrillation or cardioversion can damage a neurostimulation system and cause induced electrical currents through the lead and extension. These induced electrical currents could injure you. The current flowing through the neurostimulation system should be minimized as follows:•Paddles should be positioned as far from the neurostimulator as possible.•Paddles should be positioned perpendicular to the neurostimulation system.
Printing instructions: 37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 125•The lowest clinically appropriate energy output (watt seconds) should be used.After external defibrillation, your doctor should confirm that the neurostimulation system is working as intended.Electrocautery – If electrocautery tools are used near an implanted device or contacts a device, the following effects can occur:•The insulation on the lead or extension can be damaged, causing the lead or extension to fail or causing induced currents that can damage tissue or stimulate or shock you.•The neurostimulator can be damaged, stimulation can be temporarily decreased or increased, or the neurostimulator can be turned OFF because the neurostimulator was reset to power-on-reset values (requiring your health care provider to reprogram your neurostimulator).
220907005 Rev X37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 126When electrocautery is necessary, these precautions must be followed:•The neurostimulator should be turned OFF before using electrocautery.•Bipolar cautery should be used.•If unipolar cautery is necessary:–only low-voltage modes should be used.–the lowest possible power setting should be used.–the current path (ground plate) should be kept as far away as possible from the neurostimulator, extension, and lead.–full-length operating-room-table grounding pads should not be used.•After electrocautery, your doctor should confirm that the neurostimulator is working as intended.
Printing instructions: 37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 127High-output ultrasonics / lithotripsy –Use of high-output ultrasonics or lithotripsy is not recommended if you have an implanted neurostimulation system. If lithotripsy must be used, the beam should not be focused within 15 cm (6 in) of the neurostimulator.Magnetic resonance imaging (MRI) –Medtronic recommends that an MRI should not be prescribed for you if you have any part of an implanted neurostimulation system. Exposing you to an MRI can potentially injure you or damage your neurostimulator. The known potential risks are as follows:•Induced electrical currents from the MRI to the neurostimulation system can cause heating, especially at the lead electrode site, resulting in tissue damage. Induced electrical currents can also stimulate or shock you.
220907005 Rev X37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 128Note: This warning applies even if only a lead or an extension is implanted in your body.Factors that increase the risks of heating and injury include, but are not limited to, the following:–High MRI Specific Absorption Rate (SAR) Radio Frequency (RF) power levels–Lower impedance leads or extensions (Medtronic product names or model numbers designated with a “Z”, an “LZ”, or “Low Impedance”)–MRI RF transmit coil that is near or extends over the implanted lead–Implanted leads with small surface area electrodes–Short distances between lead electrodes and tissue that is sensitive to heat
Printing instructions: 37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 129•An MRI can permanently damage the neurostimulator, requiring it be removed or replaced.•An MRI can affect neurostimulator operation. The MRI can also reset the neurostimulator to power-on-reset values requiring your health care provider to reprogram your neurostimulator.•The neurostimulator can move within the implant pocket and align with the MRI field, resulting in discomfort or reopening of a recent implant incision.In addition, the MRI image can be degraded, distorted, or blocked from view by your implanted neurostimulation system.Radiofrequency (RF) / microwave ablation – Safety has not been established for radiofrequency (RF) or microwave ablation in patients with an implanted neurostimulation system. Induced electrical currents can cause heating, especially at the lead electrode site, resulting in tissue damage.
220907005 Rev X37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 130Theft detectors and security devices –Use care when approaching theft detector and security devices (such as those found in airports, libraries, and some department stores). When approaching these devices, do the following:1. Show the security personnel your patient identification card for the neurostimulator and ask for a manual search. Security personnel may use a handheld security wand but ask them not to hold the security wand near the neurostimulator any longer than is needed.2. If you must pass through the theft detector or security screening device, turn your neurostimulator OFF, approach the center of the device and walk through normally.a. If two security gates are present, walk through the middle, keeping as far away as possible from each gate.b. If one gate is present, walk as far away as possible from it.
Printing instructions: 37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 131Figure 7.1 Approaching security gates.Note: Some theft detectors might not be visible.3. Proceed through the security device. Do not linger near or lean on the security device.4. After you pass through the security device, turn your neurostimulator ON again.Double Security gateSingle security gate (stay as far as possible from gate)
220907005 Rev X37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 132PrecautionsEMI from the following equipment is unlikely to affect your neurostimulation system if the guidelines below are followed:Bone growth stimulators – The coils of an external magnetic field bone growth stimulator should be kept 45 cm (18 in) away from the neurostimulation system. When a bone growth stimulator is used, your doctor should ensure that both the bone growth stimulator and neurostimulator are working as intended.Dental drills and ultrasonic probes – The neurostimulator should be turned OFF and the drill or probe should be kept at least 15 cm (6 in) away from the neurostimulator.Electrolysis – The neurostimulator should be turned OFF, and the electrolysis wand should be kept at least 15 cm (6 in) away from the neurostimulator.
Printing instructions: 37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 133Electromagnetic field devices – The following equipment or environments should be avoided:•Antennas of citizen band (CB) or ham radios•Electric arc welding equipment•Electric induction heaters•Electric steel furnaces•High-power amateur transmitters•High-voltage areas (safe if outside the fenced area)•Linear power amplifiers•Magnetic degaussing equipment•Magnets and other equipment that generate strong magnetic fields•Microwave communication transmitters (safe if outside the fenced area)•Perfusion systems•Resistance welders
220907005 Rev X37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 134•Television and radio transmitting towers (safe if outside the fenced area)If you suspect that equipment is interfering with the neurostimulation system, do the following:1. Move away from the equipment or object.2. If possible, turn off the equipment or object.3. Then, if necessary, use the patient programmer to return the neurostimulator to the desired ON or OFF state.4. Inform the equipment owner or operator about the interference.If the above actions do not resolve the effects of the interference, or you suspect that your therapy is not the same after exposure to EMI, contact your doctor.Laser procedures – The neurostimulator should be turned OFF, and the laser should be directed away from the neurostimulation system.
Printing instructions: 37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 135Psychotherapeutic procedures – Safety has not been established for psychotherapeutic procedures using equipment that generates electromagnetic interference (eg, electroconvulsive therapy, transcranial magnetic stimulation) in patients who have an implanted neurostimulation system. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage.Radiation therapy – High radiation sources such as cobalt 60 or gamma radiation should not be directed at the neurostimulation system. If radiation therapy is required near the neurostimulation system, lead shielding should be placed over the device to help prevent damage.Transcutaneous electrical nerve stimulation (TENS) – TENS electrodes should not be placed so that current passes over any part of the neurostimulation system. If you feel that the TENS unit might be interfering with your neurostimulator,
220907005 Rev X37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 136discontinue using the TENS until you talk with your doctor.NotesHousehold items – Most household appliances and equipment that work properly and are properly grounded will not interfere with the neurostimulation system. The following equipment is safe if you follow these guidelines:•Computer disk drives: Keep the neurostimulator away from disk drives.•Induction range: Keep the neurostimulator away from the burners while the burners are turned on.•Freezer, refrigerator, or storm doors: Do not lean against the magnetic strip that holds the door closed.•Power tools: Keep the motor away from the neurostimulator, lead, and extension.
Printing instructions: 37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 137•Radio frequency sources: Keep AM/FM radios, and cellular, cordless, and conventional telephones at least 10 cm (4 in) away from the implanted neurostimulator.•Sewing machines or salon hair dryers: Keep the neurostimulator away from the motors.•Stereo speakers and radios for the home or car: Do not lift or carry them close to or touching the part of your body where the neurostimulator is located.Other medical procedures – EMI from the following medical procedures is unlikely to affect your neurostimulation system:•Computerized axial tomography (CT or CAT) scans•Diagnostic ultrasound (eg, carotid scan, doppler studies)Note: To minimize potential image distortion, the neurostimulator should be turned OFF and the transducer kept
220907005 Rev X37742_Ch07.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Appendix A: Electromagnetic interference 13815 cm (6 in) away from the neurostimulation system.•Diagnostic X-rays or fluoroscopyNote: Tight pressure in the area of your neurostimulator, such as used during mammography, can damage the neurostimulator or disconnect components of your neurostimulation system. This will require surgery to replace or repair the neurostimulation system. X-ray equipment should be adjusted so it does not squeeze the neurostimulator too tightly.•Magnetoencephalography (MEG)•Positron Emission Tomography (PET) scansTherapeutic magnets (eg, magnetic mattresses, blankets, wrist wraps, elbow wraps) – Keep the magnet at least 25 cm (10 in) away from your neurostimulator. Magnetic fields of 10 gauss or less will generally not affect the neurostimulator.
Printing instructions: 37742_GLS.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Glossary139GlossaryAmplitude – The strength or intensity of an electrical pulse. Caution – A statement describing actions that could result in damage to or improper functioning of a device.Charging system – Equipment used to charge the battery inside an implanted neurostimulator.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.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
220907005 Rev X37742_GLS.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Glossary140ultrasound. 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.Electrode – A metal piece near the tip of the lead. Electrodes deliver electrical pulses to the area where your pain signals will be blocked.Electromagnetic interference (EMI) – A strong field of energy near electrical or magnetic devices that could prevent the neurostimulator from functioning properly. Extension – A thin wire covered with a protective coating that connects the neurostimulator to a lead.External neurostimulator – See Neurostimulator.
Printing instructions: 37742_GLS.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Glossary141Group – Combined programs that provide stimulation to one or more pain sites. Each group may be defined for a different activity, symptom, or time of day.Group row – The middle row on the THERAPY screen. This row includes groups that a patient can change.Implanted neurostimulator – See Neurostimulator.Indication – The purpose of the neurostimulation system and the medical condition for which it may be implanted.Lead – A thin wire with protective coating that has metal electrodes on one end and a connector on the other. Neurostimulation system – Components that deliver 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.
220907005 Rev X37742_GLS.fm 10/13/04 10:21 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Glossary142– 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.Overdischarge – The neurostimulator battery continues to lose charge even after you see a low battery ( ) screen. Eventually, the battery loses enough charge to permanently affect the neurostimulator. If this occurs, the battery is overdischarged.Parameter – One of three stimulation settings that adjust the electrical pulse: amplitude, pulse width, and rate.Parameter row – The bottom row on the THERAPY Screen. Icons indicate the parameters that a patient can adjust.
Printing instructions: 37742_GLS.fm 10/13/04 10:22 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Glossary143Patient programmer – A hand-held device that allows you to turn your neurostimulator ON and OFF. It is also used to adjust some stimulation settings.Program – Stimulation directed to a specific pain site.Precaution – See Caution.Pulse width – The length or duration of an electrical pulse.Rate – The number of electrical pulses delivered each second.Settings – See Stimulation settings.SoftStart/Stop – This feature, programmed by your clinician, starts and stops stimulation gradually by slowly increasing or decreasing to the programmed amplitude or OFF. Spinal cord – This is your body’s information center. Nerve signals from the entire body travel to your spinal cord, and then to your brain.
220907005 Rev X37742_GLS.fm 10/13/04 10:22 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Glossary144Status row – The top row on the THERAPY screen. Icons represent information about the neurostimulator and the patient programmer.Stimulation – The delivery of electrical pulses to the area where pain signals are blocked as they move to the brain. Stimulation blocks some pain signals from reaching the brain.Stimulation settings – Refers to all the features assembled to define the stimulation you feel. The clinician programs all stimulation settings. You can adjust some stimulation settings.Synchronize – The process of sending and receiving information between the patient programmer and neurostimulator. Test stimulation – The period of time when an external neurostimulator is used to determine if stimulation blocks the pain signals effectively.
Printing instructions: 37742_GLS.fm 10/13/04 10:22 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Glossary145Therapy – Treatment of a disease or condition. When neurostimulation therapy is prescribed, a neurostimulation system is used to deliver stimulation to one or more pain sites.THERAPY screen – The main screen displayed on the patient programmer. Warning – A statement describing an action or situation that could harm the patient.Warning screen – A screen displayed on the patient programmer that alerts you to a problem with the programmer, antenna, or neurostimulator.
220907005 Rev X37742_GLS.fm 10/13/04 10:22 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Glossary146
Printing instructions: 37742IX.fm 10/13/04 10:22 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Index147IndexActivities 32, 34, 48Adjusting stimulation guidelines 66–68Adjusting stimulation settings 70–78Adverse effects 22Amplitudedescription 43increasing or decreasing 75–78reduce to lowest setting 35Antenna, detachable 91–93Antenna, internal (patient programmer) 54, 55Audiochanging preference 85–89tones 71, 96, 101Backlight (Power/Backlight) key 84Batteries (external neurostimulator)battery level screen 104checking 60–61replacing 61warning screen 97Batteries (patient programmer)about 79caution 79checking 79–80disposing of 117replacing 81
220907005 Rev X37742IX.fm 10/13/04 10:22 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Index148Battery (implanted neurostimulator)battery level screen 104charging 46, 63–64checking 61–64warning screen 98Bone growth stimulators 132Cardioversion 124Carrying case 89CAT scans 137Cell phones 137Change row 86Changes in stimulation, unexpected 34, 68Changing a group 73–74Charging implanted neurostimulator battery 46, 63–64Charging system 40, 41, 42Checking batteriesexternal neurostimulator 60–61implanted neurostimulator 61–64patient programmer 79–80Clinician programmer 45Communication screens 100Complications, system 22Computerized axial tomography 137Contraindications 20Contrast preference 85–89Cremation 117CT scans 137Decrease key 77, 84Decreasing a parameter 75–78Defibrillation 124
Printing instructions: 37742IX.fm 10/13/04 10:22 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Index149Dental drills 132Diathermy 20, 122Disposing ofimplanted neurostimulator 117patient programmer 117patient programmer batteries 117Driving 35Electrocautery 125Electrolysis 132Electromagnetic field devices 133Electromagnetic interference (EMI) 23–28, 122–138Error codes 99Extensions 42External neurostimulatorSee Neurostimulator (external)Fluoroscopy 138Group row 57, 73Group row icons 58Group, changing 73–74Groups 43–44Hiking 34Household items 136Hyperbaric chambers 34Identification label 90Implanted neurostimulatorSee Neurostimulator (implanted)Increase key 77, 84Increasing a parameter 75–78Indications 20Information screens 100–105
220907005 Rev X37742IX.fm 10/13/04 10:22 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Index150InterferenceSee Electromagnetic interference (EMI)Keys (patient programmer) 82–84Laser procedures 134Leads 42Lithotripsy 127Lower limit screens 78Magnetic resonance imaging (MRI) 127Magnetoencephalography (MEG) 138Magnets, therapeutic 138Mammography 138Microwave ablation 129Navigator key 71, 82Neurostimulation system parts 40Neurostimulatorpurpose 20Neurostimulator (external)battery level screen 104battery warning screen 97checking battery level 60–61description 41replacing batteries 61turning ON or OFF 69when to turn OFF 35
Printing instructions: 37742IX.fm 10/13/04 10:22 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Index151Neurostimulator (implanted)battery level screen 104battery warning screen 98charging the battery 46, 63–64checking battery level 61–64description 41disposing of 117turning ON or OFF 69when to turn OFF 35Neurostimulator OFF key 56, 83Neurostimulator ON key 56, 83Number format preference 85–89Options icon 72Parameter limit screens 78Parameter row 57Parameter row icons 59Parameter, increasing or decreasing 75–78Patient identification card 17Patient programmerbatteries 79–81cleaning and care 32, 114description 42, 45, 54, 55disposing of 117keys 82–84preferences 85–89screens 96troubleshooting 110–111Positron Emission Tomography (PET) scans 138Power tools 35Power/Backlight key 82, 84
220907005 Rev X37742IX.fm 10/13/04 10:22 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Index152Precautions 30–35Preference icons 85Preferences, changing 85–89Pregnancy 36ProgrammerSee Patient programmerProgramsdescription 43–44navigating 76Psychotherapeutic procedures 135Pulse widthdescription 43increasing or decreasing 75–78Radiation therapy 135Radiofrequency (RF) ablation 129Ratedescription 43in programs and group 76increasing or decreasing 75–78Scheduled therapyexample 59–60icon 59Scuba diving 34Security devices 130Serial number 112Settings, adjusting stimulation 70–78Skiing 34Skydiving 34SoftStart/Stop 108Specifications 119
Printing instructions: 37742IX.fm 10/13/04 10:22 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X37742 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Index153Status row 57, 86, 88Status row icons 58Stimulationadjusting settings 70–78description 38guidelines for adjusting 66–68troubleshooting 107–109uncomfortable 69, 107unexpected 69unexpected changes 34, 68Sync key 56, 83Synchronizing 55, 56Test stimulation 41Theft detectors 130Therapy screen 55, 56Therapy screen icons 57Time format preference 85–89Time preference 85–89Tones, audio 71, 96, 101Transcutaneous electrical nerve stimulation (TENS) 135Turning neurostimulator ON or OFF 69Twiddler’s Syndrome 33Ultrasonic probes 132Ultrasonics, high-output 127Ultrasound 137Uncomfortable stimulationpreventing 69troubleshooting 107Unexpected changes in stimulation 34, 68
220907005 Rev X37742IX.fm 10/13/04 10:22 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37742 2004-08Medtronic ConfidentialNeuroPatntR00Index154Unexpected stimulation, preventing 69Upper limit screens 78Warning screens 96–99Warnings 23–30X-rays 138
37742_bcv.fm 10/13/04 10:22 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00Contacts:Asia: Medtronic International Ltd. Suite 1602 16/F, Manulife Plaza,The Lee Gardens, 33 Hysan Avenue,Causeway Bay, Hong KongTel. 852-2891-4068 Fax 852-2591-0313Medtronic Asia Ltd.3 Floor Peter Building,570-6 Shinsa-Dong Kangnam-ku,Seoul 135-120, South KoreaTel. 82-2-548-1148 Fax 82-2-518-4786Australia: Medtronic Australasia Pty. Ltd.Unit 4/446 Victoria Road, Gladesville NSW 2111Tel. 02-9879-5999 Fax 02-9879-5100Austria: Medtronic Österreich G.m.b.H.Millennium Tower, Handelskai 94-96, 1200 ViennaTel. 01-24044 Fax 01-24044-100Belgium: Medtronic Belgium S.A.Boechoutlaan 55, 1853 Strombeek-BeverTel. 02-456-0900 Fax 02-460-2667Canada: Medtronic of Canada Ltd.6733 Kitimat Road, Mississauga,Ontario L5N 1W3Tel. 905-826-6020 Fax 905-826-6620 Denmark: Medtronic-ViCare A/SBirkerød Kongevej 150B, DK-3460 BirkerødTel. 45-823366 Fax 45-823365Finland: Medtronic Finland OY/LTDSahaajankatu 24, P.O. Box 230FIN-00810 Helsinki Tel. 9-755-2500 Fax 9-755-25018France: Medtronic France S.A.S.122, avenue du Général Leclerc, 92514 Boulogne-Billancourt CedexTel. 01-5538-1700 Fax 01-5538-1800Germany: Medtronic GmbHEmanuel-Leutze-Straße 20, 40547 Düsseldorf, P.O. Box 110738Tel. 0211-52930 Fax 0211-5293100Greece: Medtronic Hellas S.A.Agias Varvaras 5, 15231 Halandri, AthensTel. +30 2 10-677 90 99 Fax 30 2 10-677 93 99Italy: Medtronic Italia SpAP.zza Indro Montanelli 30, 20099 Sesto San Giovanni (MI).Tel. 02-241371. Fax 02-241381. Via Lucrezio Caro, 63, 00193 RomaTel. 06-328141 Fax 06-3215812Japan: Medtronic JapanSolid Square West Tower 6F,580 Horikawa-cho, Saiwai-ku,Kawasaki, Kanagawa 210-0913.Tel. 044-540-6112 Fax 044-540-6200Latin America Headquarters: Medtronic, Inc.710 Medtronic Parkway,Minneapolis, MN 55432-5604 USATel. 763-514-4000 Fax 763-514-4879The Netherlands: Medtronic B.V.Earl Bakkenstraat 10, P.O.Box 2542, 6401 DA HeerlenTel. 045-5668000 Fax 045-5668668Norway: Medtronic Vingmed ASFjordveien 1, Postboks 366, 1323 HøvikTel. 67 58 06 80 Fax 67 10 12 12Portugal: Medtronic Portugal, Lda.Rua Tomás da Fonseca,Torre E 8, andar A,B,1600 - 209 LisboaTel.21-724-5100 Fax 21-724-5199Spain: Medtronic Ibérica, S.A.Centro Empresarial Miniparc III, Edificio K,Calle Caléndula, 93, El Soto de la Moraleja,28109 Alcobendas - MadridTel. 91-625-0400 Fax 91-650-7410Sweden: Medtronic ABDackevägen 33, Box 265S-177 25 JärfällaTel. 08-5222-0000 Fax 08-5222-0050Internet: www.medtronic.seSwitzerland: Medtronic (Schweiz) AGRoute du Molliau 31Case Postale 84CH-1131 TolochenazTel. 021-803-8000 Fax 021-803-8099U.K. and Ireland: Medtronic U.K. Ltd.Suite 1, Sherbourne House, Croxley Business Center, Watford,Herts WD1 8YE, United KingdomTel. 1923-212213 Fax 1923-241004USA: Medtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432-5604USATel: 763-505-0606Toll-free: 1-800-707-0933Fax 763-505-0130
37742_bcv.fm 10/13/04 10:22 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx EN220907005 Rev X Printing instructions: *220907005* © Medtronic, Inc. 2004All Rights Reserved220907005Medtronic ConfidentialNeuroPatntR00ManufacturerMedtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432-5604USAInternet: www.medtronic.comTel. 1-763-505-5000Fax 1-763-505-1000Medtronic E.C. Authorized Representative/Distributed byMedtronic B.V.Earl Bakkenstraat 106422 PJ HeerlenThe NetherlandsTel. 31-45-566-8000Fax 31-45-566-8668Europe/Africa/Middle East HeadquartersMedtronic Europe SàrlRoute du Molliau 31Case PostaleCH-1131 TolochenazSwitzerlandInternet: www.medtronic.co.ukTel. 41-21-802-7000Fax 41-21-802-7900Asia-PacificMedtronic International Ltd.Suite 1602 16/F, Manulife Plaza The Lee Gardens, 33 Hysan AvenueCauseway BayHong KongTel. 852-2891-4068Fax 852-2591-0313Contacts for specific countries are listed inside this cover.

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