Medtronic 37741 Patient Programmer User Manual 37742
Medtronic, Inc. Patient Programmer 37742
Contents
- 1. 7439 Users Manual
- 2. 37742 Users Manual
37742 Users Manual
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| Document ID | 535327 |
| Application ID | ZC9LPOlOdhpcr9mVUqXFyg== |
| Document Description | 37742 Users Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 158.79kB (1984826 bits) |
| Date Submitted | 2005-04-22 00:00:00 |
| Date Available | 2005-04-22 00:00:00 |
| Creation Date | 2004-10-13 10:15:49 |
| Producing Software | Acrobat Distiller 5.0.5 (Windows) |
| Document Lastmod | 2005-04-20 18:46:43 |
| Document Title | 37742.book |
| Document Creator | FrameMaker 7.0 |
| Document Author: | dahlk1 |
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. Part No. Writer Theresa King-Hunter Part No. Rev 220907005 Date 13 October 2004 Comments 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. 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. Page 1 Form MEDN-0043 version 6.0 Medtronic Confidential NeuroPatntR00 37742_FC.fm 10/13/04 10:16 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN PATIENT PROGRAMMER Pain therapy user manual Rx only 220907005 Rev X 37742 2005 Printing instructions: 37742_FC.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Medtronic®, Restore™, and SoftStart™ are trademarks of Medtronic, Inc. c FCC Information The following is communications regulation information on the Model 37741 Patient Programmer. FCC ID: LF537741 This device complies with Part 15 Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation. IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., could void the FCC Certification and negate your authority to operate this product. 220907005 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Contents Label symbols 1 Introduction 11 A company dedicated to patients 12 How to use this manual 13 Patient guides 15 Patient identification card 17 2 Important therapy information 19 Purpose of the device 20 Purpose of the neurostimulation system (indications) 20 Therapies that may not be used with the neurostimulation system (contraindications) 20 Risks and benefits 21 Risks of surgery 21 Possible adverse effects 22 Changes in therapy 22 Possible system complications 22 37742 2004-08 English 220907005 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Warnings 23 Precautions 30 System and therapy 30 Patient activities 32 Individualization of treatment 35 3 Introduction to stimulation 37 How stimulation works 38 Parts of your system 40 Understanding your therapy 43 Controlling your stimulation 45 What your clinician controls 45 What you control 45 Charging 46 Recovery and care 48 Contents Recovering from surgery 48 Activities 48 When to call your clinician 50 Care schedule 51 4 Using your patient programmer English 37742 2004-08 220907005 53 How the patient programmer works 54 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Synchronizing and displaying the THERAPY screen 55 Checking the external neurostimulator battery 60 Checking the implanted neurostimulator battery 61 Guidelines for adjusting your stimulation 66 Turning your neurostimulator ON or OFF 69 Adjusting stimulation settings 70 Using the NAVIGATOR key 71 Changing a group 73 Increasing or decreasing a parameter (amplitude, pulse width, or rate) 75 Patient programmer batteries 79 Summary of keys 82 Preferences: Changing the audio, contrast, time, and time/number format 85 37742 2004-08 English 220907005 Rev X Printing instructions: Contents Checking patient programmer batteries 79 Replacing patient programmer batteries 81 Medtronic Confidential NeuroPatntR00 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Using the carrying case and labeling the patient programmer 89 Optional detachable antenna 91 Connecting the antenna Using the antenna 93 5 Troubleshooting 91 95 Programmer screens 96 Warning screens 96 Communication screens 100 Information screens 100 Possible problems and solutions 106 User assistance 112 6 Maintenance 113 Contents Cleaning and care 114 Safety and technical checks 116 Battery and programmer disposal 117 Neurostimulator disposal 117 Declaration of conformity 118 Specifications 119 7 Appendix A: Electromagnetic English 37742 2004-08 220907005 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN interference (EMI) 121 Contraindication 122 Warnings 124 Precautions 132 Notes 136 Glossary 147 Contents Index 139 37742 2004-08 English 220907005 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 Contents 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 220907005 English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Sym.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Label symbols Explanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply. CE 0123 Conformité Européenne (European Conformity). This symbol means that the device fully complies with AIMD Directive 90/385/EEC (NB 0123) and R&TTE Directive 1999/5/EC. The use of this device might be subject to individual country licensing regimes in Europe. System meets the applicable Canadian [C22.2-601.1-M90 (R2001)] and US (UL 60601-1:2003) electrical safety standard requirements. Caution, consult accompanying documents Serial number Storage temperature 37742 2004-08 English 220907005 Rev X Printing instructions: Label symbols Medtronic Confidential NeuroPatntR00 37742_Sym.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Relative humidity Atmospheric pressure IEC 60601-1/EN60601-1, Type BF Equipment Non-ionizing electromagnetic radiation Screen light Antenna jack Label symbols For USA audiences only 10 220907005 English 37742 2004-08 Rev X Printing instructions: 37742_Ch01.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 1 Introduction 220907005 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch01.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN A company dedicated to patients Introduction 1 Medtronic was founded in 1949 by Earl Bakken, a graduate student in electrical engineering, and his brotherin-law, Palmer J. Hermundslie. Today Medtronic is the world leader in medical technology, pioneering therapies that restore health, extend life and alleviate pain. From its modest beginnings in a 55-square meter (600-square-foot) Minneapolis garage, we have transformed Medtronic into a worldwide company that serves customers in more than 120 countries. Each year, millions of patients are treated with Medtronic products and therapies. We invest almost $500 million each year in research and development, working closely with the world’s leading physicians and scientists to enhance our current products and therapies, and to 12 English 37742 2004-08 220907005 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch01.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN develop new ones. Although we are a large company, individual patients and their needs are still the driving force behind what we do and how we do it. Our goal is to improve the quality of your life. This booklet, which provides information about your neurostimulation system, is one small way we try to help. Welcome to the Medtronic family. We wish you well. How to use this manual • 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 37742 2004-08 English 220907005 Rev X Printing instructions: Introduction 1 Use this manual during test stimulation and after receiving an implanted neurostimulator. Ask your clinician to explain anything that is unclear. 13 37742_Ch01.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 system, and the risks, benefits, warnings, precautions, and patient activities related to your neurostimulation system. • Chapter 3, “Introduction to stimulation,” describes the therapy, neurostimulation system components, and recovery and care information. • Chapter 4, “Using your patient programmer,” describes the patient programmer and how to perform specific tasks. • Chapter 5, “Troubleshooting,” describes patient programmer warning and information screens, how to solve possible problems, and who to contact if your device is lost or broken. Introduction 1 • Chapter 6, “Maintenance,” describes how to care for your patient programmer and system specifications. 14 220907005 • Appendix A provides more information about electromagnetic interference. • A glossary is included at the end of this manual. English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch01.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Patient guides Table 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 implant Test (ENSa) Document Implant (INSb) ✓ 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. ✓ ✓ Introduction 1 Medtronic Model 37021 External Neurostimulator: Test Stimulation Patient Guide. Describes the goals, activities, components and instructions for test stimulation. 37742 2004-08 English 220907005 Rev X Printing instructions: 15 Medtronic Confidential NeuroPatntR00 37742_Ch01.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 1.1 Patient guides for test stimulation and implant (continued) Test (ENSa) Document Medtronic 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. ✓ External neurostimulator Implanted neurostimulator Introduction 1 Implant (INSb) 16 220907005 English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch01.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Patient identification card When you leave the hospital, your doctor will give you a patient identification card. This card supplies information about you, your implanted device, and your doctor. Your identification card may allow you to bypass security devices. Carry this card with you at all times. If you move, change doctors, or lose your card, contact Medtronic for a replacement card. Refer to the Medtronic contacts at the end of this manual. Introduction 1 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. 37742 2004-08 English 220907005 Rev X Printing instructions: 17 Medtronic Confidential NeuroPatntR00 Introduction 1 37742_Ch01.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 18 220907005 English 37742 2004-08 Rev X Printing instructions: 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 2 Important therapy information 220907005 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Purpose of the device The Medtronic Model 37742 Patient Programmer is designed to program the Medtronic Model 37711 Restore Neurostimulator. Important therapy information 2 Purpose of the neurostimulation system (indications) 20 220907005 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 English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN diathermy) 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. Stimulation has helped thousands of patients manage their pain and improve their quality of life. Your neurostimulation system may be used with other pain treatments. Stimulation will not cure your pain. It can, however, reduce your pain to a tolerable level and allow you to resume many of your daily activities. Risks of surgery Implanting a neurostimulation system has risks similar to spinal procedures, including spinal fluid leak, headaches, swelling, bruising, bleeding, infection, or paralysis. 37742 2004-08 English 220907005 Rev X Printing instructions: Important therapy information 2 Risks and benefits 21 Medtronic Confidential NeuroPatntR00 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN If you are on anticoagulation therapy you might be at greater risk for postoperative complications such as hematomas that could result in paralysis. Possible adverse effects Important therapy information 2 Adverse effects of stimulation are usually mild and go away when stimulation is turned OFF. These adverse effects could include radicular chest wall stimulation, uncomfortable stimulation, a jolting or shocking sensation, or persistent pain at the neurostimulator site. 22 220907005 Changes in therapy Over time there could be changes in the level of your symptom control. In most cases your doctor can correct these changes without surgery. Possible system complications The lead, extension, or neurostimulator could migrate within the body or erode through the skin. There could be undesirable changes in English 37742 2004-08 Rev X Printing instructions: 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 stimulation, 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. Warnings Electromagnetic interference (EMI) – Electromagnetic interference is a field of energy generated by equipment found in the home, work, medical or public environments that is strong enough to interfere with neurostimulator function. Neurostimulators include features that provide protection from EMI. Most electrical devices and magnets encountered in a normal day are unlikely to 37742 2004-08 English 220907005 Rev X Printing instructions: Important therapy information 2 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. 23 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 affect 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. Important therapy information 2 • System damage, resulting in a loss of or change in symptom control and requiring additional surgery. 24 220907005 • 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, English 37742 2004-08 Rev X Printing instructions: 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 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 2004-08 English 220907005 Rev X Printing instructions: Important therapy information 2 which 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. 25 26 220907005 Rev X English 37742 2004-08 Printing instructions: Household items High-output ultrasonics /lithotripsy Electromagnetic field devices (eg, arc welding, power stations) ✓ ✓ ✓ ✓ ✓ Electrocautery Electrolysis ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ Momentary increase in stimulation Device damage ✓ ✓ Serious patient injury Diathermy, therapeutic Dental drills and probes Defibrillation/ cardioversion Bone growth stimulators Device/procedure ✓ ✓ Device turns OFF or ON ✓ ✓ ✓ ✓ Intermittent stimulation page 136 page 127 page 133 page 132 page 125 page 122 page 132 page 124 page 132 See guidelines Table 2.1 Potential effects of EMI from devices or procedures Important therapy information 2 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 220907005 Rev X 37742 2004-08 English Printing instructions: ✓ ✓ Serious patient injury ✓ ✓ ✓ ✓ ✓ ✓ Momentary increase in stimulation ✓ ✓ Device damage Important therapy information 2 Theft detectors/security devices Therapeutic magnets Radiofrequency (RF)/ microwave ablation Radiation therapy Psychotherapeutic procedures Magnetic resonance imaging (MRI) Laser procedures Device/procedure ✓ ✓ ✓ ✓ Device turns OFF or ON ✓ ✓ ✓ ✓ Intermittent stimulation page 130 page 138 page 129 page 135 page 135 page 127 page 134 See guidelines Table 2.1 Potential effects of EMI from devices or procedures (continued) 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 27 28 220907005 Rev X Transcutaneous electrical nerve stimulation (TENS) Therapeutic ultrasound Device/procedure Device damage ✓ Serious patient injury ✓ ✓ Momentary increase in stimulation ✓ Device turns OFF or ON ✓ Intermittent stimulation page 135 page 122 See guidelines Table 2.1 Potential effects of EMI from devices or procedures (continued) Important therapy information 2 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 English 37742 2004-08 Printing instructions: 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 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 37742 2004-08 English 220907005 Rev X Printing instructions: Important therapy information 2 Case damage – If the neurostimulator case is ruptured or pierced due to outside forces, severe burns could result from exposure to the battery chemicals. 29 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 should reprogram your neurostimulator to a bipolar configuration and a minimum rate of 60 Hz. The cardiac device should be programmed to bipolar sensing. Precautions Important therapy information 2 System and therapy 30 220907005 Clinician programmer interaction with a cochlear implant – If you have a cochlear implant, the external portion of the cochlear system should be kept as far away as possible from the clinician programmer or the cochlear implant should be turned OFF during programming to prevent unintended audible clicks. 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 English 37742 2004-08 Rev X Printing instructions: 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 neurostimulator. To verify that inadvertent programming did not occur, clinicians familiar with each device should check the programmed settings before you are sent home from the hospital and after either device is programmed (or as soon as possible after these times). 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Important therapy information 2 Contact your doctor immediately if you notice symptoms that could be related to either device or to the medical condition treated by that device. 31 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Important therapy information 2 Patient 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. 32 220907005 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 activities Activities requiring excessive twisting or stretching – Avoid activities that put undue stress on the implanted components of your neurostimulation system. Activities that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching English 37742 2004-08 Rev X Printing instructions: 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Important therapy information 2 can cause parts of your neurostimulation system to fracture or migrate. This can result in a loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery. Spinal cord stimulation patients in particular should avoid excessive bending of the torso. 33 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Important therapy information 2 Scuba 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. 34 220907005 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 English 37742 2004-08 Rev X Printing instructions: 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 some 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. Patient management – Best results are achieved when you are fully informed about the therapy risks and benefits, surgical procedure, follow-up requirements, and selfcare responsibilities. Maximum benefits from the neurostimulation system require longterm postsurgical management. Patient selection – The neurostimulation system should not be implanted if: • your symptoms are not of physiological origin. 37742 2004-08 English 220907005 Rev X Printing instructions: Important therapy information 2 Individualization of treatment 35 37742_Ch02.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • 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 Important therapy information 2 • Pediatric use (patients under the age of 18) 36 220907005 English 37742 2004-08 Rev X Printing instructions: 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 3 Introduction to stimulation 220907005 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN How stimulation works Nerve 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. Introduction to stimulation 3 Stimulation delivers electrical pulses to the area where your pain signals will be blocked as they move to the brain (Figure 3.1). 38 220907005 Brain translates signal as pain Brain senses pain and tingling Neurostimulator pulses sent to brain Signal from foot Figure 3.1 Stimulation blocks some of the pain signals as they move to the brain. English 37742 2004-08 Rev X Printing instructions: 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Note: Stimulation will not cure your pain, nor will it block sharp pain caused by a recent injury. Area of pain Area of stimulation 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Introduction to stimulation 3 To most patients, the pulses feel like a steady, tingling sensation in the painful area (Figure 3.2). 39 Medtronic Confidential NeuroPatntR00 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Parts of your system A 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). Neurostimulator Extensions Introduction to stimulation 3 Electrodes Leads A typical neurostimulation system also includes external parts for controlling your system: a patient programmer and a charging system (Figure 3.4). 40 English 37742 2004-08 220907005 Figure 3.3 Implanted parts of a typical neurostimulation system. Rev X Printing instructions: 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Patient programmer Medtronic Confidential NeuroPatntR00 Charging system Detachable antenna (optional) Carrying case 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Introduction to stimulation 3 Figure 3.4 External parts of a typical neurostimulation system. 41 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Lead(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. Introduction to stimulation 3 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. 42 220907005 Charging system – The charging system is used to charge the implanted neurostimulator battery. English 37742 2004-08 Rev X Printing instructions: 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Understanding your therapy Stimulation 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. 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Introduction to stimulation 3 • Rate is the number of pulses delivered per second. Rate feels like “tapping.” 43 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 For 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. Introduction to stimulation 3 Group A Low back and thigh pain 44 220907005 Group B Low back, thigh and ankle pain Program 1 Program 1 Program 2 Program 2 Program 3 Figure 3.5 Example of programs and groups. English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Controlling your stimulation Your neurostimulator only accepts programming from the clinician programmer or patient programmer; other devices are not able to program your neurostimulator. What your clinician controls What you control As 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 37742 2004-08 English 220907005 Rev X Printing instructions: Introduction to stimulation 3 Your 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. 45 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 group. Talk to your clinician about the settings that apply to your therapy. Charging Introduction to stimulation 3 It 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. 46 220907005 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: English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN • 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 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Introduction to stimulation 3 – The neurostimulator battery is permanently damaged. 47 Medtronic Confidential NeuroPatntR00 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Recovery and care Recovering from surgery It 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. Introduction to stimulation 3 Activities 48 220907005 Some 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. English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN • 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). • Bathing or showering • Sexual activity • Working at home or at your business • Hobbies or activities, such as walking, gardening, cycling, or swimming • Traveling 37742 2004-08 English 220907005 Rev X Printing instructions: Introduction to stimulation 3 As you begin to feel better, you should be able to perform activities such as: 49 Medtronic Confidential NeuroPatntR00 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Remember, 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 clinician Contact your clinician if any of the following events occur: Introduction to stimulation 3 • You have pain, redness, or swelling at the incision(s) later than 6 weeks after surgery. 50 220907005 • 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. English 37742 2004-08 Rev X Printing instructions: 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Care schedule Introduction to stimulation 3 Your clinician will schedule follow-up visits to make sure you are receiving the most appropriate therapy. 37742 2004-08 English 220907005 Rev X Printing instructions: 51 Medtronic Confidential NeuroPatntR00 Introduction to stimulation 3 37742_Ch03.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 52 220907005 English 37742 2004-08 Rev X Printing instructions: 37742_Ch04.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 4 Using your patient programmer 220907005 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:18 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN How the patient programmer works Using your patient programmer 4 The 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: 54 English 37742 2004-08 220907005 • 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). Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Patient programmer Neurostimulator Internal antenna Figure 4.1 Place the patient programmer over the neurostimulator. The patient programmer is used to: • turn the neurostimulator ON or OFF. Synchronizing and displaying the THERAPY screen Synchronizing sends the settings from your neurostimulator to the patient programmer. All communication with the neurostimulator begins with synchronization. 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 • change stimulation settings. 55 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • 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. Using your patient programmer 4 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. 56 220907005 NEUROSTIMULATOR ON NEUROSTIMULATOR OFF SYNC Figure 4.2 Synchronizing your neurostimulator and patient programmer. After synchronizing, the THERAPY screen appears (Figure 4.3). English 37742 2004-08 Rev X Printing instructions: 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Status row Group row Parameter row Figure 4.3 THERAPY screen. Using your patient programmer 4 Icons on the THERAPY screen indicate your neurostimulator settings and the battery level of your neurostimulator and patient programmer (Table 4.1). 37742 2004-08 English 220907005 Rev X Printing instructions: 57 Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 4.1 THERAPY screen icons Row Status Icons Description Neurostimulator is ON (Implanted or external neurostimulator) Neurostimulator is OFF (Implanted or external neurostimulator) Implanted neurostimulator battery charge level External neurostimulator battery level Using your patient programmer 4 Programmer battery level 58 220907005 Groupa Active Not active Group name English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 4.1 THERAPY screen icons (continued) Row Parameter Icons Description Amplitude Pulse width Rate If only one group is available, this row is blank. If you cannot change any parameters, this row is blank. If 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: 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 59 Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN • Group B is active most of the day and stimulation is ON • Stimulation is stopped during sleep Stimulation is stopped Group B is active Figure 4.4 Example of scheduled therapy. Using your patient programmer 4 Checking the external neurostimulator battery Check the external neurostimulator battery level every day. 60 English 37742 2004-08 220907005 • 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). Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Battery level Replace batteries Full Figure 4.5 External neurostimulator battery status on the THERAPY screen. Screens indicating that the external neurostimulator batteries need immediate replacement are described in Table 5.1 and Table 5.3. Checking the implanted neurostimulator battery Check the implanted neurostimulator battery charge level every day. • To check the implanted neurostimulator battery charge level, hold the patient programmer over your neurostimulator 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 When the batteries are low, replace the batteries as described in the external neurostimulator patient guide. 61 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 with the screen facing outward and press the SYNC key. The THERAPY screen appears displaying the implanted neurostimulator battery level (Figure 4.6). Using your patient programmer 4 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. 62 220907005 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: English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN – 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. Battery charge level Full 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 Charge neurostimulator 63 Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN If 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. Using your patient programmer 4 Press any arrow on the NAVIGATOR key to clear this message from the screen. 64 220907005 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. English 37742 2004-08 Rev X Printing instructions: 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 4.2 Neurostimulator battery screens (continued) 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 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 • Battery function is restored; however, charging sessions may be more frequent because battery capacity has been reduced. 65 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Guidelines for adjusting your stimulation Using your patient programmer 4 To 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. 66 220907005 English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Situation Action Stimulation 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 group Stimulation does not cover painful area Increase amplitude(s) or pulse width(s) or change to a different group The pulses (tapping sensations) feel too slow Increase rate The pulses (tapping sensations) feel too fast Decrease rate 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 Table 4.3 Stimulation adjustment guidelines 67 Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 4.3 Stimulation adjustment guidelines (continued) Situation Action You 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. or Using your patient programmer 4 Change to a different group and turn ON the neurostimulator. 68 220907005 You have tried adjusting stimulation but are unable to find an effective setting. You will be passing through a theft detector or security device You will be using potentially dangerous equipment Contact your clinician. Before engaging in these activities, consult “Appendix A: Electromagnetic Interference (EMI),” for details. You will be having a medical procedure English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Turning your neurostimulator ON or OFF 1. 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. ON OFF Figure 4.7 Turning your neurostimulator ON or OFF. Caution: To prevent possible uncomfortable or unexpected stimulation 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 2. Verify that the appropriate ON or OFF icon is displayed on the THERAPY screen (Figure 4.7). 69 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 (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. Using your patient programmer 4 Note: When you turn your neurostimulator ON or OFF, the patient programmer and neurostimulator are synchronized. 70 220907005 Adjusting stimulation settings There 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. English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN • 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 key Figure 4.8 NAVIGATOR key. 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 The NAVIGATOR key arrows move the selection box on the THERAPY screen (Figure 4.8). 71 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • 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. Using your patient programmer 4 • 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. 72 220907005 A row continues when the OPTIONS icon is displayed at the end of a row (Figure 4.9). Selection box Options icon Figure 4.9 The OPTIONS icon and selection box. English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Changing a group 1. 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 Group row 73 Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Figure 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). Using your patient programmer 4 5. Verify that the new group is active the THERAPY screen (Figure 4.12). 74 220907005 Figure 4.12 Active group. English 37742 2004-08 Rev X Printing instructions: on Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Increasing or decreasing a parameter (amplitude, pulse width, or rate) Notes: • To increase a parameter, the neurostimulator must be ON. 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 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 • To decrease a parameter, the neurostimulator may be ON or OFF. 75 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 2. Press the left or right arrow on the NAVIGATOR key to move the selection box to the desired parameter (Figure 4.13). Parameter row Figure 4.13 Move to parameter row. Using your patient programmer 4 Notes: 76 220907005 – 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 or DECREASE key as INCREASE English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN needed (Figure 4.14). The increase or decrease occurs immediately and is saved in the neurostimulator. DECREASE INCREASE Figure 4.14 DECREASE and INCREASE keys. – 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 Notes: 77 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 4.4 Parameter limit screens Lower limit You 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 limit Press any arrow on the Navigator key to clear the screen. Using your patient programmer 4 78 220907005 You tried to increase a parameter (amplitude, pulse width, or rate) above the highest value allowed. English 37742 2004-08 Rev X Printing instructions: 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Patient programmer batteries Always 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. The 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). 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 Checking patient programmer batteries 79 37742_Ch04.fm 10/13/04 10:19 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Battery level Replace batteries Full Figure 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 screens Using your patient programmer 4 The patient programmer batteries are low. You can finish programming. 80 220907005 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. English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Replacing patient programmer batteries 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 1. Open the battery compartment cover (Figure 4.16). 81 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Summary of keys DECREASE NEUROSTIMULATOR ON NEUROSTIMULATOR OFF SYNC INCREASE POWER/ BACKLIGHT NAVIGATOR Using your patient programmer 4 Figure 4.17 Patient programmer keys. 82 220907005 English 37742 2004-08 Rev X Printing instructions: 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 4.6 Summary of keys Key Function Turns the neurostimulator ON OFF ON OFF or • 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. The programmer must be held over the neurostimulator while pressing the SYNC key. 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 Activates a selected group. 83 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 4.6 Summary of keys (continued) Key Function Decreases parameter. Decrease Increase or increases • 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. Using your patient programmer 4 The OPTIONS icon at the end of a row on the THERAPY screen indicates that the row continues. 84 220907005 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. English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Preferences: Changing the audio, contrast, time, and time/ number format Programmer preferences are accessed from the Status row of the THERAPY screen. Table 4.7 lists the preference icons. Table 4.7 Preference icons Icons Preference Audio Contrast Time and number format 1. Hold the patient programmer over your neurostimulator with the screen facing outward and press the SYNC key. The THERAPY screen appears. 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 Time 85 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 2. Press the up arrow on the NAVIGATOR key to move the selection box to the Status row (Figure 4.18). Status row Figure 4.18 Preferences are accessed from the Status row. Using your patient programmer 4 3. Press the left or right arrow on the NAVIGATOR key to move the selection box to the desired preference (Figure 4.19). 86 220907005 Desired preference Figure 4.19 Move to desired preference. 4. Press the down arrow to move the selection box to the Change row (Figure 4.20). English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Change row Figure 4.20 Move to Change row. 5. Follow the steps in Table 4.8 to change the selected preference. Table 4.8 Changing preferences 1. 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. Contrast 1. Press the left or right arrow on the NAVIGATOR key to make the contrast lighter or darker . 2. Go to step 6, page 89. 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 Audio 87 Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 4.8 Changing preferences (continued) Time 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. Using your patient programmer 4 5. Press the SYNC key to send the change to your neurostimulator. 88 220907005 6. To verify the time change, repeat steps 2 and 3 on page 86 to return to the time preference screen. English 37742 2004-08 Rev X Printing instructions: 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 4.8 Changing preferences (continued) Time and number format 3.50 1. 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. 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 programmer The carrying case has a pouch to hold the patient programmer and the quick reference guide (Figure 4.21). 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 6. 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. 89 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 The case also has a loop on the back that attaches to a belt. Figure 4.21 Insert the programmer into the case. Using your patient programmer 4 Place an identification label on the back of your patient programmer in case the programmer is lost (Figure 4.22). 90 220907005 ID label Figure 4.22 Place the adhesive label on the back of the programmer. English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Optional detachable antenna The 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 antenna Figure 4.23 Place the antenna over your neurostimulator. 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 1. Place the antenna over your neurostimulator (Figure 4.23). 91 Medtronic Confidential NeuroPatntR00 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 2. 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). Using your patient programmer 4 92 220907005 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). English 37742 2004-08 Rev X Printing instructions: 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Figure 4.25 Insert the antenna plug into the antenna jack. Using the antenna 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Using your patient programmer 4 After the antenna is connected, follow the instructions for using the patient programmer. 93 Medtronic Confidential NeuroPatntR00 Using your patient programmer 4 37742_Ch04.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 94 220907005 English 37742 2004-08 Rev X Printing instructions: 37742_Ch05.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 5 Troubleshooting 220907005 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch05.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN This 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 screens Troubleshooting 5 The 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 screens 96 English 37742 2004-08 220907005 Warning 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 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch05.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN describes warning screens and provides instructions (see blue text) on how to resolve the problem and clear the screen. Table 5.1 Warning screens Screen Cause and action Synchronize programmer and neurostimulator The programmer and the neurostimulator must be synchronized. Synchronize the programmer and neurostimulator. Replace the external neurostimulator batteries The external neurostimulator batteries are depleted and stimulation is not available. Replace the programmer batteries The programmer batteries are depleted. Programming is not possible. Replace the programmer batteries now. 37742 2004-08 English 220907005 Rev X Printing instructions: Troubleshooting 5 Replace the external neurostimulator batteries now. Refer to the manual packaged with the external neurostimulator. 97 Medtronic Confidential NeuroPatntR00 37742_Ch05.fm 10/13/04 10:20 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 5.1 Warning screens (continued) Screen Cause and action Charge the implanted neurostimulator battery 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. 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. Troubleshooting 5 Allowing the neurostimulator battery to overdischarge will permanently affect the neurostimulator in one of the following ways: 98 220907005 • 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: English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 5.1 Warning screens (continued) Screen Cause and action - 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. Other codes: Write down the code shown on the screen. Call your doctor. 37742 2004-08 English 220907005 Rev X Printing instructions: Troubleshooting 5 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. 99 Medtronic Confidential NeuroPatntR00 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Communication screens The 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. Troubleshooting 5 100 220907005 Table 5.2 Communication screens Screen Description and action Communication The programmer is communicating with the implanted neurostimulator. Communication The programmer is communicating with the external neurostimulator. Information screens The information screens show the programming status and the battery level for English 37742 2004-08 Rev X Printing instructions: 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 your 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 screens Screen Description and action Poor communication The programmer attempted to communicate with the implanted neurostimulator, but communication was unsuccessful. If using the detachable antenna, check that the antenna is connected properly, reposition the antenna and try communication again. 37742 2004-08 English 220907005 Rev X Printing instructions: Troubleshooting 5 Reposition the programmer over the implanted neurostimulator with the screen facing outward and try communication again. 101 Medtronic Confidential NeuroPatntR00 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 5.3 Programmer information screens (continued) Screen Description and action Poor communication The 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. Troubleshooting 5 If using the detachable antenna, check that the antenna is connected properly, reposition the antenna and try communication again. 102 220907005 Press You tried increasing a parameter NEUROSTIMULATOR value with the neurostimulator ON key OFF. Turn your neurostimulator ON and try communication again. English 37742 2004-08 Rev X Printing instructions: 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 5.3 Programmer information screens (continued) Screen Description and action Upper limit (amplitude shown) You tried increasing a parameter (amplitude, pulse width, or rate) above the highest value allowed. 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Troubleshooting 5 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. 103 Medtronic Confidential NeuroPatntR00 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 5.3 Programmer information screens (continued) Screen Description and action Implanted neurostimulator battery charge level is low 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. External neurostimulator batteries are low The 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. Troubleshooting 5 Programmer batteries are low 104 220907005 The patient programmer batteries are low. You can finish programming. Replace the programmer batteries before the batteries become depleted. English 37742 2004-08 Rev X Printing instructions: 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 5.3 Programmer information screens (continued) Screen Description and action Sync up You tried increasing or decreasing a parameter for an inactive group. Synchronize the programmer and neurostimulator. Patient programmer information Troubleshooting 5 These screens provide Neurostimulation information to your clinician or Medtronic during system troubleshooting. information Communication information 37742 2004-08 English 220907005 Rev X Printing instructions: 105 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Possible problems and solutions Table 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). Troubleshooting 5 Note: If a problem is not solved after several attempts, or if a problem is not described here, contact your clinician. 106 220907005 English 37742 2004-08 Rev X Printing instructions: 220907005 Rev X Troubleshooting 5 The selected group or stimulation settings are not suitable for your current activity or posture. Uncomfortable stimulation: You are too uncomfortable with the current stimulation to think about how to change it. 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. 3. Reduce the rate for the active group. 1. Turn the neurostimulator OFF. 2. Reduce the amplitude and pulse width for each program in the active group. Causes and actions Problems Table 5.4 Troubleshooting problems 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 37742 2004-08 English Printing instructions: 107 108 220907005 Rev X Intermittent stimulation: You feel stimulation only some of the time. Your clinician programmed SoftStart/Stop so that stimulation starts and stops gradually: Delayed 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 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. You may feel a residual effect after the neurostimulator is turned OFF. Allow about 8 seconds for your neurostimulator to turn ON and OFF. Causes and actions Problems Table 5.4 Troubleshooting problems (continued) Troubleshooting 5 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 English 37742 2004-08 Printing instructions: 220907005 Rev X Troubleshooting 5 Stimulation is OFF. No stimulation: You do not feel stimulation but you think stimulation should be ON. Use your patient programmer to increase the amplitude(s). The amplitudes for each program in the active group are set too low to feel. If stimulation is desired, select another group and turn stimulation ON. Your clinician has programmed scheduled therapy and stimulation is scheduled to be stopped at this time. Use your patient programmer to turn your neurostimulator ON. Causes and actions Problems Table 5.4 Troubleshooting problems (continued) 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 37742 2004-08 English Printing instructions: 109 110 220907005 Rev X Dropped programmer: Your patient programmer falls off a cabinet or table. The programmer batteries are depleted. Patient programmer is unresponsive: The display screen is blank when you press a key. Try the patient programmer; it should work. 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. Check the battery polarity and reinstall the patient programmer batteries. The programmer batteries are in backwards. Replace the programmer batteries. Causes and actions Problems Table 5.4 Troubleshooting problems (continued) Troubleshooting 5 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 English 37742 2004-08 Printing instructions: 220907005 Rev X Troubleshooting 5 The patient programmer is not waterproof, and water can damage the device. Fluid on the programmer: Fluid was spilled onto the programmer or the programmer was dropped into water. Remove the batteries, then allow the battery compartment to air dry at room temperature for 24 hours. Immediately remove the programmer from the water, then dry the programmer with a towel dampened with clean tap water. Causes and actions Problems Table 5.4 Troubleshooting problems (continued) 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 37742 2004-08 English Printing instructions: 111 37742_Ch05.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 User assistance The 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. Troubleshooting 5 If you lose your programmer – Contact your clinician to order a new programmer. 112 220907005 To register the programmer for service covered by the warranty, complete and mail the warranty registration. English 37742 2004-08 Rev X Printing instructions: 37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 6 Maintenance 220907005 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN This section describes how to care for and dispose of your patient programmer and accessories. Cleaning and care Follow 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. Maintenance 6 • Keep the device out of the reach of children. 114 220907005 • Use the device only as explained to you by your clinician or as discussed in this manual. English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN • 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. Maintenance 6 • Replace low or depleted batteries. 37742 2004-08 English 220907005 Rev X Printing instructions: 115 Medtronic Confidential NeuroPatntR00 37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Safety and technical checks Periodic 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. USA Medtronic, Inc. Neurological Division MSN600 PO Box 1250 Minneapolis, MN 55440-9087 Maintenance 6 Europe, Africa, Middle East, and Asia-Pacific countries 116 220907005 Medtronic EOC Medical Equipment Service Europe Earl Bakkenstraat 10 6422 P J Heerlen The Netherlands Tel. 31-45566-4880 Fax 31-45566-8028 English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Battery and programmer disposal Dispose 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 disposal Maintenance 6 The 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. 37742 2004-08 English 220907005 Rev X Printing instructions: 117 Medtronic Confidential NeuroPatntR00 37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Declaration of conformity Medtronic 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. Maintenance 6 For additional information, contact Medtronic. Refer to the list of Medtronic contacts at the end of this manual. 118 220907005 English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Specifications Table 6.1 Patient programmer specifications Item Specification Power 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 30% to 95% relative humidity 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 batteries Mode of operation Continuous 37742 2004-08 English 220907005 Rev X Printing instructions: Maintenance 6 Operating/storage 700 hPa to 1060 hPa atmospheric (20.7 in. Hg to 31.3 in. Hg) pressure 119 Medtronic Confidential NeuroPatntR00 37742_Ch06.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 6.2 Implanted neurostimulation system specifications Description Specifications Typical materials in contact with human tissuea Titanium Polyurethane Silicone rubber Polysulfone Silicone medical adhesive Lead Polyurethane Platinum iridium Extension Polyurethane For a complete list of materials in contact with human tissue, contact your clinician. Maintenance 6 Neurostimulator 120 220907005 English 37742 2004-08 Rev X Printing instructions: 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 7 Appendix A: Electromagnetic interference (EMI) 220907005 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Appendix A: Electromagnetic interference Please review “Electromagnetic interference (EMI)” on page 23 and Table 2.1 on page 26 for additional information. 122 220907005 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. Contraindication Diathermy – Inform anyone treating you that you CANNOT have any shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) anywhere on your body because you have an implanted neurostimulation system. Energy from English 37742 2004-08 Rev X Printing instructions: 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 diathermy can be transferred through your implanted system, can cause tissue damage, and can result in severe injury or death. 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Appendix A: Electromagnetic interference 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. 123 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Warnings Appendix A: Electromagnetic interference EMI 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: 124 220907005 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. English 37742 2004-08 Rev X Printing instructions: 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • 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. • 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-onreset values (requiring your health care provider to reprogram your neurostimulator). 37742 2004-08 English 220907005 Rev X Printing instructions: Appendix A: Electromagnetic interference Electrocautery – If electrocautery tools are used near an implanted device or contacts a device, the following effects can occur: 125 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 When 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. Appendix A: Electromagnetic interference – the lowest possible power setting should be used. 126 220907005 – 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. English 37742 2004-08 Rev X Printing instructions: 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Appendix A: Electromagnetic interference High-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. 127 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Note: 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: Appendix A: Electromagnetic interference – High MRI Specific Absorption Rate (SAR) Radio Frequency (RF) power levels 128 220907005 – 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 English 37742 2004-08 Rev X Printing instructions: 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • An MRI can permanently damage the neurostimulator, requiring it be removed or replaced. • 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Appendix A: Electromagnetic interference • 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. 129 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Appendix A: Electromagnetic interference Theft 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: 130 220907005 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. English 37742 2004-08 Rev X Printing instructions: 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Double Security gate Medtronic Confidential NeuroPatntR00 Single security gate (stay as far as possible from gate) 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Appendix A: Electromagnetic interference Figure 7.1 Approaching security gates. 131 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Precautions Appendix A: Electromagnetic interference EMI from the following equipment is unlikely to affect your neurostimulation system if the guidelines below are followed: 132 220907005 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. English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Electromagnetic 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-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 37742 2004-08 English 220907005 Rev X Printing instructions: Appendix A: Electromagnetic interference • High-power amateur transmitters 133 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • 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. Appendix A: Electromagnetic interference 2. If possible, turn off the equipment or object. 134 220907005 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. English 37742 2004-08 Rev X Printing instructions: 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 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, 37742 2004-08 English 220907005 Rev X Printing instructions: Appendix A: Electromagnetic interference Psychotherapeutic 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. 135 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 discontinue using the TENS until you talk with your doctor. Notes Appendix A: Electromagnetic interference Household 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: 136 220907005 • 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. English 37742 2004-08 Rev X Printing instructions: 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • Radio frequency sources: Keep AM/FM radios, and cellular, cordless, and conventional telephones at least 10 cm (4 in) away from the implanted neurostimulator. • 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 37742 2004-08 English 220907005 Rev X Printing instructions: Appendix A: Electromagnetic interference • Sewing machines or salon hair dryers: Keep the neurostimulator away from the motors. 137 Medtronic Confidential NeuroPatntR00 37742_Ch07.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 15 cm (6 in) away from the neurostimulation system. • Diagnostic X-rays or fluoroscopy Appendix A: Electromagnetic interference Note: 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. 138 220907005 • Magnetoencephalography (MEG) • Positron Emission Tomography (PET) scans Therapeutic 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. English 37742 2004-08 Rev X Printing instructions: 37742_GLS.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Glossary Amplitude – 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. 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 37742 2004-08 English 220907005 Rev X Printing instructions: Glossary Contraindication – A condition or circumstance when a person should not have a neurostimulation system. 139 Medtronic Confidential NeuroPatntR00 37742_GLS.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN ultrasound. Depending on the power level used, diathermy devices may or may not produce heat within the body. This treatment is typically used to relieve pain, stiffness and muscle spasms, reduce joint contractures, reduce swelling and pain after surgery, and promote wound healing. 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. Glossary External neurostimulator – See Neurostimulator. 140 220907005 English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_GLS.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Group – 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. Neurostimulator – The power source of a neurostimulation system. It contains the battery and electronics that control the stimulation you feel. 37742 2004-08 English 220907005 Rev X Printing instructions: Glossary Neurostimulation system – Components that deliver electrical pulses to block pain signals as they move to the brain. 141 37742_GLS.fm 10/13/04 10:21 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 – 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. Glossary Parameter row – The bottom row on the THERAPY Screen. Icons indicate the parameters that a patient can adjust. 142 220907005 English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 37742_GLS.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Patient 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. 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. 37742 2004-08 English 220907005 Rev X Printing instructions: Glossary SoftStart/Stop – This feature, programmed by your clinician, starts and stops stimulation gradually by slowly increasing or decreasing to the programmed amplitude or OFF. 143 37742_GLS.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Status 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. Glossary Synchronize – The process of sending and receiving information between the patient programmer and neurostimulator. 144 220907005 Test stimulation – The period of time when an external neurostimulator is used to determine if stimulation blocks the pain signals effectively. English 37742 2004-08 Rev X Printing instructions: 37742_GLS.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Therapy – 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. Glossary Warning screen – A screen displayed on the patient programmer that alerts you to a problem with the programmer, antenna, or neurostimulator. 37742 2004-08 English 220907005 Rev X Printing instructions: 145 Medtronic Confidential NeuroPatntR00 Glossary 37742_GLS.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 146 220907005 English 37742 2004-08 Rev X Printing instructions: 37742IX.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Index Index Activities 32, 34, 48 Adjusting stimulation guidelines 66–68 Adjusting stimulation settings 70–78 Adverse effects 22 Amplitude description 43 increasing or decreasing 75–78 reduce to lowest setting 35 Antenna, detachable 91–93 Antenna, internal (patient programmer) 54, 55 Audio changing preference 85–89 tones 71, 96, 101 Backlight (Power/Backlight) key 84 Batteries (external neurostimulator) battery level screen 104 checking 60–61 replacing 61 warning screen 97 Batteries (patient programmer) about 79 caution 79 checking 79–80 disposing of 117 replacing 81 37742 2004-08 English 220907005 Rev X Printing instructions: 147 Index 37742IX.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 148 220907005 Medtronic Confidential NeuroPatntR00 Battery (implanted neurostimulator) battery level screen 104 charging 46, 63–64 checking 61–64 warning screen 98 Bone growth stimulators 132 Cardioversion 124 Carrying case 89 CAT scans 137 Cell phones 137 Change row 86 Changes in stimulation, unexpected 34, 68 Changing a group 73–74 Charging implanted neurostimulator battery 46, 63–64 Charging system 40, 41, 42 Checking batteries external neurostimulator 60–61 implanted neurostimulator 61–64 patient programmer 79–80 Clinician programmer 45 Communication screens 100 Complications, system 22 Computerized axial tomography 137 Contraindications 20 Contrast preference 85–89 Cremation 117 CT scans 137 Decrease key 77, 84 Decreasing a parameter 75–78 Defibrillation 124 English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 Dental drills 132 Diathermy 20, 122 Disposing of implanted neurostimulator 117 patient programmer 117 patient programmer batteries 117 Driving 35 Electrocautery 125 Electrolysis 132 Electromagnetic field devices 133 Electromagnetic interference (EMI) 23–28, 122–138 Error codes 99 Extensions 42 External neurostimulator See Neurostimulator (external) Fluoroscopy 138 Group row 57, 73 Group row icons 58 Group, changing 73–74 Groups 43–44 Hiking 34 Household items 136 Hyperbaric chambers 34 Identification label 90 Implanted neurostimulator See Neurostimulator (implanted) Increase key 77, 84 Increasing a parameter 75–78 Indications 20 Information screens 100–105 37742 2004-08 English 220907005 Rev X Printing instructions: Index 37742IX.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 149 37742IX.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Index Interference See Electromagnetic interference (EMI) Keys (patient programmer) 82–84 Laser procedures 134 Leads 42 Lithotripsy 127 Lower limit screens 78 Magnetic resonance imaging (MRI) 127 Magnetoencephalography (MEG) 138 Magnets, therapeutic 138 Mammography 138 Microwave ablation 129 Navigator key 71, 82 Neurostimulation system parts 40 Neurostimulator purpose 20 Neurostimulator (external) battery level screen 104 battery warning screen 97 checking battery level 60–61 description 41 replacing batteries 61 turning ON or OFF 69 when to turn OFF 35 150 220907005 English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 Neurostimulator (implanted) battery level screen 104 battery warning screen 98 charging the battery 46, 63–64 checking battery level 61–64 description 41 disposing of 117 turning ON or OFF 69 when to turn OFF 35 Neurostimulator OFF key 56, 83 Neurostimulator ON key 56, 83 Number format preference 85–89 Options icon 72 Parameter limit screens 78 Parameter row 57 Parameter row icons 59 Parameter, increasing or decreasing 75–78 Patient identification card 17 Patient programmer batteries 79–81 cleaning and care 32, 114 description 42, 45, 54, 55 disposing of 117 keys 82–84 preferences 85–89 screens 96 troubleshooting 110–111 Positron Emission Tomography (PET) scans 138 Power tools 35 Power/Backlight key 82, 84 37742 2004-08 English 220907005 Rev X Printing instructions: Index 37742IX.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 151 Medtronic Confidential NeuroPatntR00 Index 37742IX.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 152 220907005 Precautions 30–35 Preference icons 85 Preferences, changing 85–89 Pregnancy 36 Programmer See Patient programmer Programs description 43–44 navigating 76 Psychotherapeutic procedures 135 Pulse width description 43 increasing or decreasing 75–78 Radiation therapy 135 Radiofrequency (RF) ablation 129 Rate description 43 in programs and group 76 increasing or decreasing 75–78 Scheduled therapy example 59–60 icon 59 Scuba diving 34 Security devices 130 Serial number 112 Settings, adjusting stimulation 70–78 Skiing 34 Skydiving 34 SoftStart/Stop 108 Specifications 119 English 37742 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 Status row 57, 86, 88 Status row icons 58 Stimulation adjusting settings 70–78 description 38 guidelines for adjusting 66–68 troubleshooting 107–109 uncomfortable 69, 107 unexpected 69 unexpected changes 34, 68 Sync key 56, 83 Synchronizing 55, 56 Test stimulation 41 Theft detectors 130 Therapy screen 55, 56 Therapy screen icons 57 Time format preference 85–89 Time preference 85–89 Tones, audio 71, 96, 101 Transcutaneous electrical nerve stimulation (TENS) 135 Turning neurostimulator ON or OFF 69 Twiddler’s Syndrome 33 Ultrasonic probes 132 Ultrasonics, high-output 127 Ultrasound 137 Uncomfortable stimulation preventing 69 troubleshooting 107 Unexpected changes in stimulation 34, 68 37742 2004-08 English 220907005 Rev X Printing instructions: Index 37742IX.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 153 Medtronic Confidential NeuroPatntR00 37742IX.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Index Unexpected stimulation, preventing 69 Upper limit screens 78 Warning screens 96–99 Warnings 23–30 X-rays 138 154 220907005 English 37742 2004-08 Rev X Printing instructions: 37742_bcv.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Contacts: Asia: Medtronic International Ltd. Suite 1602 16/F, Manulife Plaza, The Lee Gardens, 33 Hysan Avenue, Causeway Bay, Hong Kong Tel. 852-2891-4068 Fax 852-2591-0313 Medtronic Asia Ltd. 3 Floor Peter Building, 570-6 Shinsa-Dong Kangnam-ku, Seoul 135-120, South Korea Tel. 82-2-548-1148 Fax 82-2-518-4786 Australia: Medtronic Australasia Pty. Ltd. Unit 4/446 Victoria Road, Gladesville NSW 2111 Tel. 02-9879-5999 Fax 02-9879-5100 Austria: Medtronic Österreich G.m.b.H. Millennium Tower, Handelskai 94-96, 1200 Vienna Tel. 01-24044 Fax 01-24044-100 Belgium: Medtronic Belgium S.A. Boechoutlaan 55, 1853 Strombeek-Bever Tel. 02-456-0900 Fax 02-460-2667 Canada: Medtronic of Canada Ltd. 6733 Kitimat Road, Mississauga, Ontario L5N 1W3 Tel. 905-826-6020 Fax 905-826-6620 Denmark: Medtronic-ViCare A/S Birkerød Kongevej 150B, DK-3460 Birkerød Tel. 45-823366 Fax 45-823365 Finland: Medtronic Finland OY/LTD Sahaajankatu 24, P.O. Box 230 FIN-00810 Helsinki Tel. 9-755-2500 Fax 9-755-25018 France: Medtronic France S.A.S. 122, avenue du Général Leclerc, 92514 Boulogne-Billancourt Cedex Tel. 01-5538-1700 Fax 01-5538-1800 Germany: Medtronic GmbH Emanuel-Leutze-Straße 20, 40547 Düsseldorf, P.O. Box 110738 Tel. 0211-52930 Fax 0211-5293100 Greece: Medtronic Hellas S.A. Agias Varvaras 5, 15231 Halandri, Athens Tel. +30 2 10-677 90 99 Fax 30 2 10-677 93 99 Italy: Medtronic Italia SpA P.zza Indro Montanelli 30, 20099 Sesto San Giovanni (MI). Tel. 02-241371. Fax 02-241381. Via Lucrezio Caro, 63, 00193 Roma Tel. 06-328141 Fax 06-3215812 220907005 Rev X Japan: Medtronic Japan Solid Square West Tower 6F, 580 Horikawa-cho, Saiwai-ku, Kawasaki, Kanagawa 210-0913. Tel. 044-540-6112 Fax 044-540-6200 Latin America Headquarters: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA Tel. 763-514-4000 Fax 763-514-4879 The Netherlands: Medtronic B.V. Earl Bakkenstraat 10, P.O.Box 2542, 6401 DA Heerlen Tel. 045-5668000 Fax 045-5668668 Norway: Medtronic Vingmed AS Fjordveien 1, Postboks 366, 1323 Høvik Tel. 67 58 06 80 Fax 67 10 12 12 Portugal: Medtronic Portugal, Lda. Rua Tomás da Fonseca, Torre E 8, andar A,B, 1600 - 209 Lisboa Tel.21-724-5100 Fax 21-724-5199 Spain: Medtronic Ibérica, S.A. Centro Empresarial Miniparc III, Edificio K, Calle Caléndula, 93, El Soto de la Moraleja, 28109 Alcobendas - Madrid Tel. 91-625-0400 Fax 91-650-7410 Sweden: Medtronic AB Dackevägen 33, Box 265 S-177 25 Järfälla Tel. 08-5222-0000 Fax 08-5222-0050 Internet: www.medtronic.se Switzerland: Medtronic (Schweiz) AG Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Tel. 021-803-8000 Fax 021-803-8099 U.K. and Ireland: Medtronic U.K. Ltd. Suite 1, Sherbourne House, Croxley Business Center, Watford, Herts WD1 8YE, United Kingdom Tel. 1923-212213 Fax 1923-241004 USA: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Tel: 763-505-0606 Toll-free: 1-800-707-0933 Fax 763-505-0130 Printing instructions: 37742_bcv.fm 10/13/04 10:22 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Manufacturer Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Internet: www.medtronic.com Tel. 1-763-505-5000 Fax 1-763-505-1000 Medtronic E.C. Authorized Representative/Distributed by Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. 31-45-566-8000 Fax 31-45-566-8668 Europe/Africa/Middle East Headquarters Medtronic Europe Sàrl Route du Molliau 31 Case Postale CH-1131 Tolochenaz Switzerland Internet: www.medtronic.co.uk Tel. 41-21-802-7000 Fax 41-21-802-7900 Asia-Pacific Medtronic International Ltd. Suite 1602 16/F, Manulife Plaza The Lee Gardens, 33 Hysan Avenue Causeway Bay Hong Kong Tel. 852-2891-4068 Fax 852-2591-0313 Contacts for specific countries are listed inside this cover. *220907005* 220907005 Rev X © Medtronic, Inc. 2004 All Rights Reserved 220907005 Printing instructions:
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