Medtronic 37741 Patient Programmer User Manual 7439
Medtronic, Inc. Patient Programmer 7439
Contents
- 1. 7439 Users Manual
- 2. 37742 Users Manual
7439 Users Manual
Neurological Medtronic Confidential Title Model 7439 Patient Programmer User Manual Global 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 Part No. Rev 221244001 Date 11/03/04 Theresa King-Hunter Comments Release for translation 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): 136 7. Note to print supplier: Supplier may add up to three blank pages at the end of the document before the back cover sheet as needed. If more are required, contact the purchasing agent. 8. Vendor-supplied information may appear at an appropriate location on the literature piece (eg, part number, bar code, etc.). 9. Graphics Content and Layout to be as shown and per Medtronic electronic file that is supplied (stored) by Medtronic Neuro. Page 1 Form MEDN-0043 version 7.0 Medtronic Confidential NeuroPatntR00 7439_FC.fm 10/13/04 9:26 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN PATIENT PROGRAMMER Pain therapy user manual c Rx only 221244001 Rev X 7439 2004 Printing instructions: 7439_FC.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 The following are trademarks of Medtronic, Inc.: Medtronic®, MyStim™, SoftStart™, Synergy Plus+™, Synergy Compact+™, and Synergy®. c FCC Information The following is communications regulation information on the Model 7439 Patient Programmer. FCC ID: LF537741 This device complies with Part 15 Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation. IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., could void the FCC Certification and negate your authority to operate this product. 221244001 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439TOC.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Contents Label symbols 1 Introduction A company dedicated to patients 10 How to use this manual 11 Patient guides 13 Patient identification card 14 2 Important therapy information 15 Purpose of the neurostimulation system (indications) 16 Therapies that may not be used with the neurostimulation system (contraindications) 16 Risks and benefits 17 18 Warnings 19 Precautions 26 System and therapy 26 7439 2004-08 English 221244001 Rev X Printing instructions: Contents Risks of surgery 17 Possible adverse effects 18 Changes in therapy 18 Possible system complications Medtronic Confidential NeuroPatntR00 7439TOC.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Patient activities 29 Individualization of treatment 31 3 Introduction to stimulation 33 How stimulation works 34 Parts of your system 36 Understanding your therapy 38 Controlling your stimulation 40 What your clinician controls 40 What you control 40 Recovery and care 41 Recovering from surgery 41 Activities 41 When to call your clinician 43 Care schedule 44 Contents 4 Using your patient programmer 221244001 45 How the patient programmer works 46 Synchronizing and displaying the THERAPY screen 48 Guidelines for adjusting your stimulation 53 Turning your neurostimulator ON or OFF 55 English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439TOC.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Adjusting stimulation settings 57 Using the NAVIGATOR key 58 Changing a group 59 Increasing or decreasing a parameter (amplitude, pulse width, or rate) 62 Patient programmer batteries 66 Checking patient programmer batteries 66 Replacing patient programmer batteries 68 Summary of keys 69 Preferences: Changing the audio, contrast, and number format 72 Using the carrying case and labeling the patient programmer 75 Optional detachable antenna 76 Connecting the antenna Using the antenna 78 79 Programmer screens 80 Warning screens 80 Communication screen 82 7439 2004-08 English 221244001 Rev X Printing instructions: Contents 5 Troubleshooting 76 Medtronic Confidential NeuroPatntR00 7439TOC.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Information screens 83 Possible problems and solutions 88 User assistance 95 6 Maintenance 97 Cleaning and care 98 Safety and technical checks 100 Battery and programmer disposal 101 Neurostimulator disposal 101 Declaration of conformity 102 Specifications 103 7 Appendix A: Electromagnetic interference (EMI) 105 Contraindication 106 Warnings 108 Precautions 116 Notes 120 Contents Glossary 221244001 Index 123 129 English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Sym.fm 10/13/04 9:27 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 Conformité Européenne 0123 (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 Label symbols 7439 2004-08 English 221244001 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Sym.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Storage temperature Relative humidity Atmospheric pressure IEC 60601-1/EN60601-1, Type BF Equipment Non-ionizing electromagnetic radiation Screen light Antenna jack Label symbols 221244001 For USA audience only The Medtronic Model 7439 Patient Programmer is designed to program the adjustable settings of the Medtronic Model 7479 Synergy Plus+ and Model 7479B Synergy Compact+ neurostimulators. English 7439 2004-08 Rev X Printing instructions: 7439_Ch01.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 1 Introduction 221244001 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch01.fm 10/13/04 9:27 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 10 English 7439 2004-08 221244001 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch01.fm 10/13/04 9:27 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 Use this manual after receiving an implanted neurostimulator. Ask your clinician to explain anything that is unclear. • Chapter 2, “Important therapy information,” describes when you should and should not use a neurostimulation 7439 2004-08 English 221244001 Rev X Printing instructions: Introduction 1 • Chapter 1, “Introduction,” describes the patient documents your clinician should have provided to you. 11 7439_Ch01.fm 10/13/04 9:27 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. 12 221244001 • Appendix A provides more information about electromagnetic interference. • A glossary is included at the end of this manual. English 7439 2004-08 Rev X Printing instructions: 7439_Ch01.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Patient guides You should receive the following documents after a neurostimulator is implanted. • Medtronic Model 7439 Patient Programmer Quick Reference Guide: provides instructions for common patient programmer tasks. • The Patient Identification Card: provides information about you, your neurostimulator, and your doctor. Introduction 1 • Medtronic Model 7439 Patient Programmer Pain Therapy User Manual. 7439 2004-08 English 221244001 Rev X Printing instructions: 13 Medtronic Confidential NeuroPatntR00 7439_Ch01.fm 10/13/04 9:27 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 c A temporary identification card will be provided at the hospital. After Medtronic receives your implant registration from the hospital, you will receive a permanent identification card. 14 221244001 English 7439 2004-08 Rev X Printing instructions: 7439_Ch02.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 2 Important therapy information 221244001 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch02.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Purpose of the neurostimulation system (indications) Important therapy information 2 Refer to the indications sheet that is packaged with the patient programmer for the purpose of the neurostimulation system and related information. 16 221244001 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 diathermy) anywhere on your body because you have an implanted neurostimulation system. Energy from diathermy can be transferred through your implanted system, English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch02.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN and can cause tissue damage, resulting in severe injury or death. Refer to “Appendix A: Electromagnetic interference (EMI)” on page 105 for more information. Risks and benefits Risks of surgery Implanting a neurostimulation system has risks similar to spinal procedures, including spinal fluid leak, headaches, swelling, bruising, bleeding, infection, or paralysis. If you are on anticoagulation therapy you might be at greater risk for postoperative 7439 2004-08 English 221244001 Rev X Printing instructions: Important therapy information 2 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. 17 Medtronic Confidential NeuroPatntR00 7439_Ch02.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN complications such as hematomas that could result in paralysis. Possible adverse effects Adverse effects of stimulation are usually mild and go away when stimulation is turned OFF. These adverse effects could include radicular chest wall stimulation, uncomfortable stimulation, a jolting or shocking sensation, or persistent pain at the neurostimulator site. Important therapy information 2 Changes in therapy 18 221244001 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 stimulation, possibly related to cellular changes around the electrode(s), changes in English 7439 2004-08 Rev X Printing instructions: 7439_Ch02.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 the position of the electrode(s), loose electrical connections, or lead or extension fractures. It is also possible that the implanted materials could cause an allergic or immune system response. Your neurostimulation system might unexpectedly cease to function due to battery depletion or other causes. These events, which can include electrical shorts or open circuits, conductor (wire) fractures, and insulation breaches, cannot be predicted. Electromagnetic interference (EMI) – Electromagnetic interference is a field of energy generated by equipment found in the home, work, medical or public environments that is strong enough to interfere with neurostimulator function. Neurostimulators include features that provide protection from EMI. Most electrical devices and magnets encountered in a normal day are unlikely to affect the operation of a neurostimulator. 7439 2004-08 English 221244001 Rev X Printing instructions: Important therapy information 2 Warnings 19 7439_Ch02.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 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. 20 221244001 • 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, which some patients have described as a English 7439 2004-08 Rev X Printing instructions: 7439_Ch02.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 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. Important therapy information 2 Refer to Table 2.1, on page 22, and “Appendix A: Electromagnetic interference (EMI)” on page 105 for information on the sources of EMI, the effect of EMI on you and your neurostimulation system, and instructions on how to reduce the risk from EMI. 7439 2004-08 English 221244001 Rev X Printing instructions: 21 22 221244001 Rev X English 7439 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 120 page 111 page 117 page 116 page 109 page 106 page 116 page 108 page 116 See guidelines Table 2.1 Potential effects of EMI from devices or procedures Important therapy information 2 7439_Ch02.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 221244001 Rev X 7439 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 114 page 122 page 113 page 119 page 119 page 111 page 118 See guidelines Table 2.1 Potential effects of EMI from devices or procedures (continued) 7439_Ch02.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 23 24 221244001 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 119 page 106 See guidelines Table 2.1 Potential effects of EMI from devices or procedures (continued) Important therapy information 2 7439_Ch02.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 English 7439 2004-08 Printing instructions: 7439_Ch02.fm 10/13/04 9:28 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 7439 2004-08 English 221244001 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. 25 7439_Ch02.fm 10/13/04 9:28 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 26 221244001 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 7439 2004-08 Rev X Printing instructions: 7439_Ch02.fm 10/13/04 9:28 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, only components that are compatible with the appropriate indication (eg, spinal cord stimulation) should be used. For a list of Medtronic-compatible components, ask your doctor. No claims of safety or efficacy are made about the compatibility of non-Medtronic components with Medtronic components. Patient control devices – Do not place patient control devices (eg, patient programmer) over another device (eg, 7439 2004-08 English 221244001 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. 27 7439_Ch02.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 pacemaker, defibrillator, another neurostimulator). The patient control device could accidently change the operation of another device. 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. 28 221244001 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. English 7439 2004-08 Rev X Printing instructions: 7439_Ch02.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Patient activities Component manipulation – Do not manipulate or rub your neurostimulation system through the skin, sometimes called “Twiddler’s Syndrome.” Manipulation can cause damage to your system, skin erosion, or stimulation at the implant site. 7439 2004-08 English 221244001 Rev X Printing instructions: Important therapy information 2 Activities requiring excessive twisting or stretching – Avoid activities that put undue stress on the implanted components of your neurostimulation system. Activities that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching can cause parts of your neurostimulation system to fracture or migrate. This can result in a loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery. Spinal cord stimulation patients in particular should avoid excessive bending of the torso. 29 7439_Ch02.fm 10/13/04 9:28 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. 30 221244001 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 7439 2004-08 Rev X Printing instructions: 7439_Ch02.fm 10/13/04 9:28 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. 7439 2004-08 English 221244001 Rev X Printing instructions: Important therapy information 2 Individualization of treatment 31 7439_Ch02.fm 10/13/04 9:28 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) 32 221244001 English 7439 2004-08 Rev X Printing instructions: 7439_Ch03.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 3 Introduction to stimulation 221244001 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch03.fm 10/13/04 9:28 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). 34 221244001 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 7439 2004-08 Rev X Printing instructions: 7439_Ch03.fm 10/13/04 9:28 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. 7439 2004-08 English 221244001 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). 35 Medtronic Confidential NeuroPatntR00 7439_Ch03.fm 10/13/04 9:28 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 36 221244001 Leads Figure 3.3 Implanted parts of a typical neurostimulation system. A typical neurostimulation system also includes a patient programmer that allows you to control some stimulation settings.(Figure 3.4). English 7439 2004-08 Rev X Printing instructions: 7439_Ch03.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Detachable antenna (optional) Medtronic Confidential NeuroPatntR00 Patient programmer Carrying case Figure 3.4 Patient programmer with accessories. 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. Patient programmer – A patient programmer is a hand-held device that you use to select and adjust your stimulation. A 7439 2004-08 English 221244001 Rev X Printing instructions: Introduction to stimulation 3 Neurostimulator – The neurostimulator is the power source for your neurostimulation system. It contains electronics that generate the electrical pulses. 37 7439_Ch03.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 detachable antenna is also available if you have difficulty reaching the neurostimulator implant site. 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. Introduction to stimulation 3 • Amplitude is the strength of the pulse. It affects the stimulation strength or coverage required to manage your pain. 38 221244001 • Pulse width is the duration of the pulse. It affects the stimulation strength or coverage required to manage your pain. • Rate is the number of pulses delivered per second. Rate feels like “tapping.” A program delivers electrical pulses to a specified pain site. Programs are combined into “groups” to provide stimulation to more than one pain site. English 7439 2004-08 Rev X Printing instructions: 7439_Ch03.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 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. For example, Alex has pain in his low back. Typically, Alex’s pain doesn’t vary; however, sometimes Alex has additional pain in his right thigh. 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 thigh pain (Figure 3.5). Alex chooses whichever group he requires. Program 1 Group B Low back and thigh pain Program 1 Program 2 Figure 3.5 Example of programs and groups. 7439 2004-08 English 221244001 Rev X Printing instructions: Introduction to stimulation 3 Group A Low back pain 39 Medtronic Confidential NeuroPatntR00 7439_Ch03.fm 10/13/04 9:28 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 Introduction to stimulation 3 Your clinician uses a clinician programmer to communicate with your neurostimulator and your patient programmer. 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. 40 221244001 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 English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch03.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN group. Talk to your clinician about the settings that apply to your therapy. 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. 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. 7439 2004-08 English 221244001 Rev X Printing instructions: Introduction to stimulation 3 Activities 41 Medtronic Confidential NeuroPatntR00 7439_Ch03.fm 10/13/04 9:28 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 2.3 kilograms (5 pounds). Introduction to stimulation 3 As you begin to feel better, you should be able to perform activities such as: 42 221244001 • Bathing or showering • Sexual activity • Working at home or at your business • Hobbies or activities, such as walking, gardening, cycling, or swimming • Traveling English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch03.fm 10/13/04 9:28 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: • 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. 7439 2004-08 English 221244001 Rev X Printing instructions: Introduction to stimulation 3 • You have pain, redness, or swelling at the incision(s) later than 6 weeks after surgery. 43 7439_Ch03.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Care schedule Your clinician will schedule follow-up visits to make sure you are receiving the most appropriate therapy. Introduction to stimulation 3 Note: Bring your patient programmer to all appointments with your clinician. When groups are programmed, some settings are stored in your neurostimulator and some settings are stored in your patient programmer. To most effectively evaluate your therapy, the clinician needs your patient programmer. 44 221244001 English 7439 2004-08 Rev X Printing instructions: 7439_Ch04.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 4 Using your patient programmer 221244001 Rev X Printing instructions: 7439_Ch04.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 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, or the detachable antenna, must be placed over the neurostimulator (Figure 4.1). Notes: 46 English 7439 2004-08 221244001 • The internal antenna is on the back of the programmer. • The programmer screen must face outward. • The detachable antenna plugs into the patient programmer. Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:28 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. Using your patient programmer 4 • change stimulation settings. 7439 2004-08 English 221244001 Rev X Printing instructions: 47 7439_Ch04.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 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. Using your patient programmer 4 • 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. 48 221244001 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. English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN NEUROSTIMULATOR ON NEUROSTIMULATOR OFF SYNC Figure 4.2 Synchronizing your neurostimulator and patient programmer. Status row Group row Parameter row 3.40 Figure 4.3 THERAPY screen. Icons on the THERAPY screen indicate your neurostimulator settings and the patient programmer battery level (Table 4.1). 7439 2004-08 English 221244001 Rev X Printing instructions: Using your patient programmer 4 After synchronizing, the THERAPY screen appears (Figure 4.3). 49 Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 4.1 THERAPY screen icons Row Icons Status Description Neurostimulator is ON Neurostimulator is OFF Day Cycling is ON Neurostimulator battery level is low Patient programmer battery level Group Not active Using your patient programmer 4 50 221244001 Active Group name Unknown group English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:28 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 Amplitude Pulse width Pulse width Rate If you cannot change any parameters, this row is blank. If your clinician scheduled a time when stimulation is OFF (eg, when you sleep), the DAY CYCLING ( ) icon is displayed in the Status row (Figure 4.4). Note: Whether DAY CYCLING IS ON or OFF, you can turn stimulation ON or OFF at any time. 7439 2004-08 English 221244001 Rev X Printing instructions: Using your patient programmer 4 51 Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN An example of Day Cycling is shown in Figure 4.4. The screens and timetable show the following: • When stimulation is ON, the NEUROSTIMULATOR ON icon is displayed. Stimulation is ON for most of the day. • When stimulation is OFF, the NEUROSTIMULATOR OFF icon is displayed. Stimulation is OFF during the time you would be asleep. Using your patient programmer 4 Stimulation is ON 52 221244001 Stimulation is OFF 3.40 3.40 Figure 4.4 Example of Day Cycling. English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:28 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Guidelines for adjusting your stimulation 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 4.2 provides general guidelines for adjusting your stimulation. 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 7439 2004-08 English 221244001 Rev X Printing instructions: Using your patient programmer 4 Table 4.2 Stimulation adjustment guidelines 53 Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Using your patient programmer 4 Table 4.2 Stimulation adjustment guidelines (continued) 54 221244001 Situation Action The pulses (tapping sensations) feel too slow Increase rate The pulses (tapping sensations) feel too fast Decrease rate 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 Change to a different group and turn ON the neurostimulator. You have tried adjusting stimulation but are unable to find an effective setting. Contact your clinician. English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 4.2 Stimulation adjustment guidelines (continued) Situation You will be passing through a theft detector or security device You will be using potentially dangerous equipment Action Before engaging in these activities, consult “Appendix A: Electromagnetic Interference (EMI),” for details. You will be having a medical procedure 1. Hold the programmer over your neurostimulator with the programmer screen facing outward and press the NEUROSTIMULATOR ON or NEUROSTIMULATOR OFF key (Figure 4.5). The THERAPY screen appears. 2. Verify that the appropriate ON or OFF icon is displayed on the THERAPY screen (Figure 4.5). 7439 2004-08 English 221244001 Rev X Printing instructions: Using your patient programmer 4 Turning your neurostimulator ON or OFF 55 Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN ON OFF 3.40 3.40 Figure 4.5 Turning your neurostimulator ON or OFF. Using your patient programmer 4 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. 56 221244001 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 62. Note: When you turn your neurostimulator ON or OFF, the patient programmer and neurostimulator are synchronized. English 7439 2004-08 Rev X Printing instructions: 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 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. • When a stimulation setting is changed, you will see the change on the THERAPY screen. – One tone means the stimulation setting was successfully changed. – Three rapid tones mean the stimulation setting change did not occur. – Up to ten short tones means the patient programmer is unsuccessfully trying to establish communication with the neurostimulator. 7439 2004-08 English 221244001 Rev X Printing instructions: Using your patient programmer 4 • If the audio is ON, the following tones mean: 57 Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Using the NAVIGATOR key The NAVIGATOR key arrows move the selection box on the THERAPY screen (Figure 4.6). Using your patient programmer 4 Figure 4.6 NAVIGATOR key. 58 221244001 • To move the selection box between rows press the up and down arrows on the NAVIGATOR key. • To move the selection box across a row that continues, press the left and right arrows on the NAVIGATOR key. • When moving the selection box with the NAVIGATOR key, you do not need to hold your programmer over your English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN neurostimulator. However, you must hold your programmer over your neurostimulator when pressing all other keys except the POWER key. A row continues when the OPTIONS icon is displayed at the end of a row (Figure 4.7). Selection box OPTIONS icon 3.50 Figure 4.7 The OPTIONS icon and selection box. 1. Hold the patient programmer over your neurostimulator with the screen facing outward and press the SYNC key. The THERAPY screen appears. Note: Changing a group may take up to 8 seconds. 2. Press the up arrow on the NAVIGATOR key to move the selection box to the Group row (Figure 4.8). 7439 2004-08 English 221244001 Rev X Printing instructions: Using your patient programmer 4 Changing a group 59 Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Group row Figure 4.8 Group row. Using your patient programmer 4 3. Press the left or right arrows on the NAVIGATOR key to move the selection box to the desired group (Figure 4.9). 60 221244001 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. Figure 4.9 Move to a new group. English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 4. Hold the programmer over your neurostimulator and press the SYNC key to send the change to your neurostimulator (Figure 4.10). Note: If an UNKNOWN GROUP icon is displayed, there is a conflict between the group settings stored in the programmer and the group settings stored in the neurostimulator. Select a different group. on Figure 4.10 Active group. 7439 2004-08 English 221244001 Rev X Printing instructions: Using your patient programmer 4 5. Verify that the new group is active the THERAPY screen (Figure 4.10). 61 Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:29 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. Using your patient programmer 4 • To decrease a parameter, the neurostimulator may be ON or OFF. 62 221244001 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. English 7439 2004-08 Rev X Printing instructions: 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Notes: • To change a parameter, it must be in a group that is active • Changing a parameter takes one to two seconds. 2. Use the left or right arrow on the NAVIGATOR key to move the selection box to the desired parameter (Figure 4.11). Figure 4.11 Move to parameter row. Notes: – If there is more than one program, scroll to the right to display the amplitude ) for each program, followed by the pulse width ( ) for each program, and then the rate ( ). (Scrolling to the left reverses the order.) – The rate is the same for all programs within a group. 7439 2004-08 English 221244001 Rev X Printing instructions: Using your patient programmer 4 Parameter row 63 Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 3. Hold the programmer over your neurostimulator and press the INCREASE or DECREASE key as needed (Figure 4.12). The increase or decrease occurs immediately and is saved in the neurostimulator. DECREASE INCREASE Using your patient programmer 4 Figure 4.12 DECREASE and INCREASE keys. 64 221244001 Notes: – Pressing and holding the INCREASE or DECREASE key, changes the value approximately every half-second. – If one of the information screens in Table 4.3 appears, you tried to increase or decrease the value beyond the available limits programmed by your clinician. English 7439 2004-08 Rev X Printing instructions: 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 4.3 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. You tried to increase a parameter (amplitude, pulse width, or rate) above the highest value allowed. Press any arrow on the NAVIGATOR key to clear the screen. 7439 2004-08 English 221244001 Rev X Printing instructions: Using your patient programmer 4 Upper limit 65 7439_Ch04.fm 10/13/04 9:29 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. Using your patient programmer 4 Checking patient programmer batteries 66 221244001 The patient programmer battery level is displayed on the THERAPY screen (Figure 4.13). • 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 4.13). English 7439 2004-08 Rev X Printing instructions: 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Battery level 3.50 Low: Replace batteries New Figure 4.13 Patient programmer battery level. If the programmer batteries need immediate replacement, one of the screens in Table 4.4 appears. The patient programmer batteries are low. You can finish programming. Press any arrow on the NAVIGATOR key to clear the screen; then continue programming. Replace the programmer batteries before the batteries become depleted. The patient programmer batteries are depleted. Programming is not possible. Replace the patient programmer batteries now. 7439 2004-08 English 221244001 Rev X Printing instructions: Using your patient programmer 4 Table 4.4 Patient programmer battery replacement screens 67 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Replacing patient programmer batteries Using your patient programmer 4 1. Open the battery compartment cover (Figure 4.14). 68 221244001 Figure 4.14 Opening the battery cover. 2. Remove the depleted batteries. (For disposal information, see “Battery and programmer disposal” on page 101. 3. Insert the new batteries as shown on the battery compartment label. 4. Close the battery compartment cover. English 7439 2004-08 Rev X Printing instructions: 7439_Ch04.fm 10/13/04 9:29 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 4.15 Patient programmer keys. 7439 2004-08 English 221244001 Rev X Printing instructions: 69 Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 4.5 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. Activates a selected group. Using your patient programmer 4 The programmer must be held over the neurostimulator while pressing the SYNC key. 70 221244001 English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 4.5 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 approximately every halfsecond. The OPTION icon at the end of a row on the THERAPY screen indicates that the row continues. Turns the patient programmer power ON and OFF. Pressing and holding this key also turns the backlight ON and OFF. The backlight provides light to the display. 7439 2004-08 English 221244001 Rev X Printing instructions: Using your patient programmer 4 Moves the selection box on the THERAPY screen. 71 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Preferences: Changing the audio, contrast, and number format Programmer preferences are accessed from the Status row of the THERAPY screen. Table 4.6 lists the preference icons. Table 4.6 Preference icons Icons Preference Audio Contrast Using your patient programmer 4 Number format 72 221244001 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 Status row (Figure 4.16). English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Status row 3.50 Figure 4.16 Preferences are accessed from the Status row. 3. Press the left or right arrow on the NAVIGATOR key to move the selection box to the desired preference (Figure 4.17). Figure 4.17 Move to desired preference. 4. Press the down arrow to move the selection box to the Change row (Figure 4.18). Change row Figure 4.18 Move to Change row. 7439 2004-08 English 221244001 Rev X Printing instructions: Using your patient programmer 4 Desired preference 73 Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:29 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 5. Follow the steps in Table 4.7 to change the selected preference. Table 4.7 Changing preferences Audio 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. Contrast Using your patient programmer 4 1. Press the left or right arrow on the NAVIGATOR key to make the contrast lighter or darker . 2. Go to step 6. 74 221244001 Number format 1. Press the left or right arrow on the NAVIGATOR key to change from the comma to the decimal point format. 2. Go to step 6. 6. When the change is displayed on the screen, move the selection box to the Status (top) row and scroll back to the English 7439 2004-08 Rev X Printing instructions: 7439_Ch04.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 THERAPY screen. Scrolling to the THERAPY screen saves the change in the patient programmer. 7. Press the left or right arrow on the NAVIGATOR key to move to another preference or return to the THERAPY screen. Using the carrying case and labeling the patient programmer The case also has a loop on the back that attaches to a belt. Figure 4.19 Insert the programmer into the case. 7439 2004-08 English 221244001 Rev X Printing instructions: Using your patient programmer 4 The carrying case has a pouch to hold the patient programmer and the quick reference guide (Figure 4.19). 75 Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Place an identification label on the back of your patient programmer in case the programmer is lost (Figure 4.20). ID label Figure 4.20 Place the adhesive label on the back of the programmer. Using your patient programmer 4 Optional detachable antenna 76 221244001 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 1. Place the antenna over your neurostimulator (Figure 4.21). English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch04.fm 10/13/04 9:30 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 4.22). Figure 4.22 Pull the fabric through the slit (a) and wedge in place (b). 7439 2004-08 English 221244001 Rev X Printing instructions: Using your patient programmer 4 Figure 4.21 Place the antenna over your neurostimulator. 77 7439_Ch04.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 3. Push the antenna plug firmly into the antenna jack ( )on the patient programmer (Figure 4.23). Using your patient programmer 4 Figure 4.23 Insert the antenna plug into the antenna jack. 78 221244001 Using the antenna After the antenna is connected, follow the instructions for using the patient programmer. When you have finished using the patient programmer, grasp the antenna plug and pull it out. Caution: Do not pull directly on the antenna cable to disconnect the cable from the programmer because this may damage the antenna cable. English 7439 2004-08 Rev X Printing instructions: 7439_Ch05.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 5 Troubleshooting 221244001 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch05.fm 10/13/04 9:30 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 alert you to a problem with your system or guide you during programmer use. If the audio is ON, a series of tones alerts you to some messages. Warning screens 80 English 7439 2004-08 221244001 Warning screens indicate a problem with the programmer, antenna, or neurostimulator. Table 5.1 describes warning screens and Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch05.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 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 are not synchronized. Synchronize the programmer and neurostimulator. Replace programmer batteries The programmer batteries are depleted. Programming is not possible. Troubleshooting 5 Replace the programmer batteries now. 7439 2004-08 English 221244001 Rev X Printing instructions: 81 Medtronic Confidential NeuroPatntR00 7439_Ch05.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 5.1 Warning screens (continued) Screen Cause and action Call doctor EOS: Your neurostimulator battery is depleted. Stimulation is not available. Other code: The system is not working correctly. Stimulation might have stopped. Write down the code shown on the screen. Call your doctor. Communication screen Troubleshooting 5 A communication screen shows you that a process is in progress. Table 5.2 describes the communication screen for your neurostimulation system. 82 221244001 The communication screen automatically clears when the neurostimulation system finishes the process. English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch05.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 5.2 Communication screen Screen Description and action Communication The programmer is communicating or attempting to communicate with the neurostimulator. Information screens The information screens show the programming status and the battery level for your programmer and neurostimulator. Table 5.3 describes information screens and instructions on how to proceed (see blue text). Troubleshooting 5 Note: Press any arrow on the NAVIGATOR key to clear an information screen. 7439 2004-08 English 221244001 Rev X Printing instructions: 83 Medtronic Confidential NeuroPatntR00 7439_Ch05.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 5.3 Information screens Screen Description and action Poor communication The programmer attempted to communicate with the neurostimulator, but communication was unsuccessful. Reposition the programmer over the neurostimulator with the screen facing outward and try communication again. If using the detachable antenna, check that the antenna is connected properly, reposition the antenna, and try communication again. Press You tried increasing a NEUROSTIMULATOR ON parameter value with the key neurostimulator OFF. Troubleshooting 5 Turn your neurostimulator ON and try communication again. 84 221244001 English 7439 2004-08 Rev X Printing instructions: 7439_Ch05.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 5.3 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. Programmer batteries are low The patient programmer batteries are low. You can finish programming. Neurostimulator battery is low The neurostimulator battery is low. Stimulation will not be available soon. Write down the code shown on the screen. Call your clinician. 7439 2004-08 English 221244001 Rev X Printing instructions: Troubleshooting 5 Replace the programmer batteries before the batteries become depleted. 85 Medtronic Confidential NeuroPatntR00 7439_Ch05.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 5.3 Information screens (continued) Screen Description and action Sync up You tried to unsuccessfully change to a different group, then tried to turn the neurostimulator ON. Synchronize the programmer and neurostimulator. You tried increasing or decreasing a parameter for an inactive group. Synchronize the programmer and neurostimulator. Incorrect patient programmer 251 Use the correct patient programmer. Troubleshooting 5 86 221244001 You have more than one neurostimulator of the same type, and you are trying to use the patient programmer to communicate with the wrong neurostimulator. English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch05.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Table 5.3 Information screens (continued) Screen Description and action Patient programmer information These screens provide information to your clinician or Medtronic during troubleshooting. PA PO IS IM HI HA Troubleshooting 5 PM 7439 2004-08 English 221244001 Rev X Printing instructions: 87 7439_Ch05.fm 10/13/04 9:30 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. 88 221244001 English 7439 2004-08 Rev X Printing instructions: 221244001 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. 3. Turn the neurostimulator ON. • 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. • Reduce the rate for the active group. • Reduce the amplitude and pulse width for each program in the active group. 1. Turn the neurostimulator OFF. 2. Change one or more of the following: Causes and actions Problems Table 5.4 Troubleshooting problems 7439_Ch05.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 7439 2004-08 English Printing instructions: 89 90 221244001 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 7439_Ch05.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 English 7439 2004-08 Printing instructions: 221244001 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, turn stimulation ON. Your clinician has programmed Day Cycling and stimulation is scheduled to be OFF at this time. Use your patient programmer to turn your neurostimulator ON. Causes and actions Problems Table 5.4 Troubleshooting problems (continued) 7439_Ch05.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 7439 2004-08 English Printing instructions: 91 92 221244001 Rev X Dropped programmer: Your patient programmer falls off a cabinet or table. You are pressing two or more patient programmer keys at the same time. 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. The programmer batteries are depleted. Make sure you are pressing only one key at a time. Causes and actions Problems Table 5.4 Troubleshooting problems (continued) Troubleshooting 5 7439_Ch05.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 English 7439 2004-08 Printing instructions: 221244001 Rev X 7439 2004-08 English Printing instructions: Troubleshooting 5 ??? Cannot access or use group. 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. Choose a new group. (See Page 59). Press the Sync key. There is a conflict between the group stored in the programmer and neurostimulator. 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) 7439_Ch05.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 93 94 221244001 Rev X No group is selected. Cannot use group. Choose a new group. (See Page 59). Press the Sync key. Causes and actions Problems Table 5.4 Troubleshooting problems (continued) Troubleshooting 5 7439_Ch05.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 English 7439 2004-08 Printing instructions: 7439_Ch05.fm 10/13/04 9:30 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. c To register the programmer for service covered by the warranty, complete and mail the warranty registration. 7439 2004-08 English 221244001 Rev X Printing instructions: Troubleshooting 5 If you lose your programmer – Contact your clinician to order a new programmer. 95 Medtronic Confidential NeuroPatntR00 Troubleshooting 5 7439_Ch05.fm 10/13/04 9:30 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 96 221244001 English 7439 2004-08 Rev X Printing instructions: 7439_Ch06.fm 10/13/04 9:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 6 Maintenance 221244001 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch06.fm 10/13/04 9:31 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. 98 221244001 • Use the device only as explained to you by your clinician or as discussed in this manual. English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch06.fm 10/13/04 9:31 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 “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. 7439 2004-08 English 221244001 Rev X Printing instructions: 99 Medtronic Confidential NeuroPatntR00 7439_Ch06.fm 10/13/04 9:31 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. If the patient programmer requires repair or is nonfunctional, send it to the address listed below. The patient programmer contains no user-serviceable parts. Maintenance 6 USA Medtronic, Inc. Neurological Division MSN600 PO Box 1250 Minneapolis, MN 55440-9087 100 221244001 Europe, Africa, Middle East, and Asia-Pacific countries Medtronic EOC Medical Equipment Service Europe Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. 31-45566-4880 Fax 31-45566-8028 English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch06.fm 10/13/04 9:31 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. 7439 2004-08 English 221244001 Rev X Printing instructions: 101 Medtronic Confidential NeuroPatntR00 7439_Ch06.fm 10/13/04 9:31 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 AIMD Directive 90/385/EEC and R&TTE Directive 1999/5/EC. Maintenance 6 For additional information, contact Medtronic at the telephone numbers and addresses provided on the back cover. 102 221244001 English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch06.fm 10/13/04 9:31 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 7439 2004-08 English 221244001 Rev X Printing instructions: Maintenance 6 Operating/storage 700 hPa to 1060 hPa atmospheric (20.7 in. Hg to 31.3 in. Hg) pressure 103 7439_Ch06.fm 10/13/04 9:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 6.2 Neurostimulation system specifications Description Specifications Typical materials in contact with human tissuea Neurostimulator Case Connector block Recharge coil Grommets, seals Setscrews Insulation Adhesive Lead Polyurethane Platinum iridium Extension Polyurethane For a complete list of materials in contact with human tissue, contact your clinician. Maintenance 6 Titanium Polyurethane Polysulfone Silicone rubber Titanium Fluoropolymer Silicone adhesive 104 221244001 English 7439 2004-08 Rev X Printing instructions: 7439_Ch07.fm 10/13/04 9:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 7 Appendix A: Electromagnetic interference (EMI) 221244001 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch07.fm 10/13/04 9:31 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 19 and Table 2.1 on page 22 for additional information. 106 221244001 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 7439 2004-08 Rev X Printing instructions: 7439_Ch07.fm 10/13/04 9:31 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. 7439 2004-08 English 221244001 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. 107 7439_Ch07.fm 10/13/04 9:31 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: 108 221244001 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 7439 2004-08 Rev X Printing instructions: 7439_Ch07.fm 10/13/04 9:31 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). When electrocautery is necessary, these precautions must be followed: 7439 2004-08 English 221244001 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: 109 7439_Ch07.fm 10/13/04 9:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • The neurostimulator should be turned OFF before using electrocautery. • Bipolar cautery should be used. • If unipolar cautery is necessary: – only low-voltage modes should be used. – the lowest possible power setting should be used. Appendix A: Electromagnetic interference – the current path (ground plate) should be kept as far away as possible from the neurostimulator, extension, and lead. 110 221244001 – 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 7439 2004-08 Rev X Printing instructions: 7439_Ch07.fm 10/13/04 9:31 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. 7439 2004-08 English 221244001 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. 111 7439_Ch07.fm 10/13/04 9:31 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 112 221244001 – 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 7439 2004-08 Rev X Printing instructions: 7439_Ch07.fm 10/13/04 9:31 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. 7439 2004-08 English 221244001 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. 113 7439_Ch07.fm 10/13/04 9:31 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: 114 221244001 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 7439 2004-08 Rev X Printing instructions: 7439_Ch07.fm 10/13/04 9:31 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. 7439 2004-08 English 221244001 Rev X Printing instructions: Appendix A: Electromagnetic interference Figure 7.1 Approaching security gates. 115 7439_Ch07.fm 10/13/04 9:31 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: 116 221244001 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 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439_Ch07.fm 10/13/04 9:31 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 7439 2004-08 English 221244001 Rev X Printing instructions: Appendix A: Electromagnetic interference • High-power amateur transmitters 117 7439_Ch07.fm 10/13/04 9:31 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. 118 221244001 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 7439 2004-08 Rev X Printing instructions: 7439_Ch07.fm 10/13/04 9:31 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, 7439 2004-08 English 221244001 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. 119 7439_Ch07.fm 10/13/04 9:31 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: 120 221244001 • 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 7439 2004-08 Rev X Printing instructions: 7439_Ch07.fm 10/13/04 9:31 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 7439 2004-08 English 221244001 Rev X Printing instructions: Appendix A: Electromagnetic interference • Sewing machines or salon hair dryers: Keep the neurostimulator away from the motors. 121 Medtronic Confidential NeuroPatntR00 7439_Ch07.fm 10/13/04 9:31 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. 122 221244001 • 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 7439 2004-08 Rev X Printing instructions: 7439_GLS.fm 10/13/04 9:31 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. Clinician – A healthcare professional such as a doctor or nurse. Clinician programmer – A device used by a clinician to send instructions to the neurostimulator and the patient programmer. Diathermy – A medical treatment applied to the outside of the body that delivers energy into the body. Three types of energy that can be used are shortwave, microwave, and ultrasound. Depending on the power level used, diathermy devices may or may not produce heat within the body. This treatment is typically used to relieve pain, stiffness and 7439 2004-08 English 221244001 Rev X Printing instructions: Glossary Contraindication – A condition or circumstance when a person should not have a neurostimulation system. 123 7439_GLS.fm 10/13/04 9:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 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 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. 124 221244001 Group row – The middle row on the THERAPY screen. This row includes groups that a patient can change. English 7439 2004-08 Rev X Printing instructions: 7439_GLS.fm 10/13/04 9:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Indication – The purpose of the neurostimulation system and the medical condition for which it may be implanted. Information screen – A screen displayed on the patient programmer that alerts you to a problem with the programmer, antenna, or neurostimulator. Lead – A thin wire with protective coating that has metal electrodes on one end and a connector on the other. Neurostimulation system – Components that deliver electrical pulses to block pain signals as they move to the brain. Parameter – One of three stimulation settings that adjust the electrical pulse: amplitude, pulse width, and rate. 7439 2004-08 English 221244001 Rev X Printing instructions: Glossary Neurostimulator – The power source of a neurostimulation system. It contains the battery and electronics that control the stimulation you feel. 125 Medtronic Confidential NeuroPatntR00 7439_GLS.fm 10/13/04 9:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Parameter row – The bottom row on the THERAPY screen. Icons indicate the parameters that a patient can adjust. 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. Programming – Using a clinician or patient programmer to communicate stimulation settings to a neurostimulator. Precaution – See Caution. Pulse width – The length or duration of an electrical pulse. Rate – The number of electrical pulses delivered each second. Glossary Settings – See Stimulation settings. 126 221244001 English 7439 2004-08 Rev X Printing instructions: 7439_GLS.fm 10/13/04 9:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 SoftStart/Stop – This feature, programmed by your clinician, starts and stops stimulation gradually by slowly increasing or decreasing to the programmed amplitude or OFF. Spinal cord – This is your body’s information center. Nerve signals from the entire body travel to your spinal cord, and then to your brain. Status row – The top row on the THERAPY screen. Icons represent information about the neurostimulator and the patient programmer. 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. 7439 2004-08 English 221244001 Rev X Printing instructions: Glossary 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. 127 7439_GLS.fm 10/13/04 9:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Synchronize – The process of sending and receiving information between the patient programmer and neurostimulator. Therapy – Treatment of a disease or condition. When neurostimulation therapy is prescribed, a neurostimulation system is used to deliver stimulation to one or more 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. 128 221244001 English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439IX.fm 10/13/04 9:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Activities 29, 30, 41 Adjusting stimulation guidelines 53–55 Adjusting stimulation settings 57–65 Adverse effects 18 Amplitude description 38 increasing or decreasing 62–65 reduce to lowest setting 31 Antenna, detachable 76–78 Antenna, internal (patient programmer) 46 Audio changing preference 72–75 tones 57, 80 Backlight (Power/Backlight) key 71 Batteries (patient programmer) about 66 caution 66 checking 66–67 disposing of 101 replacing 68 Bone growth stimulators 116 Cardioversion 108 Carrying case 75 CAT scans 121 Cell phones 121 Change row 73 Changes in stimulation, unexpected 30, 54 Changing a group 59–61 7439 2004-08 English 221244001 Rev X Printing instructions: Index Index 129 Index 7439IX.fm 10/13/04 9:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 130 221244001 Medtronic Confidential NeuroPatntR00 Checking batteries patient programmer 66–67 Clinician programmer 40 Communication screens 82 Complications, system 18 Computerized axial tomography 121 Contraindications 16 Contrast preference 72–75 Cremation 101 CT scans 121 Day cycling example 52 icon 51 Decrease key 64, 71 Decreasing a parameter 62–65 Defibrillation 108 Dental drills 116 Diathermy 16 Disposing of neurostimulator 101 patient programmer 101 patient programmer batteries 101 Driving 31 Electrocautery 109 Electrolysis 116 Electromagnetic field devices 117 Electromagnetic interference (EMI) 19–24, 106–122 Error codes 82 Extensions 37 Fluoroscopy 122 English 7439 2004-08 Rev X Printing instructions: 7439IX.fm 10/13/04 9:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Index Group row 49, 60 Group row icons 50 Group, changing 59–61 Groups 38–39 Hiking 30 Household items 120 Hyperbaric chambers 30 Identification label 76 Increase key 64, 71 Increasing a parameter 62–65 Indications 16 Information screens 83–87 Interference See Electromagnetic interference (EMI) Keys (patient programmer) 69–71 Laser procedures 118 Leads 37 Lithotripsy 111 Lower limit screens 65 Magnetic resonance imaging (MRI) 111 Magnetoencephalography (MEG) 122 Magnets, therapeutic 122 Mammography 122 Microwave ablation 113 Navigator key 58, 69 Neurostimulation system parts 36 7439 2004-08 English 221244001 Rev X Printing instructions: 131 Index 7439IX.fm 10/13/04 9:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 132 221244001 Medtronic Confidential NeuroPatntR00 Neurostimulator description 37 disposing of 101 low battery screen 85 turning ON or OFF 55 when to turn OFF 31 Neurostimulator OFF key 49, 70 Neurostimulator ON key 49, 70 Number format preference 72–75 Options icon 59 Parameter limit screens 65 Parameter row 49 Parameter row icons 51 Parameter, increasing or decreasing 62–65 Patient identification card 14 Patient programmer batteries 66–68 cleaning and care 28, 98 description 37, 40, 46, 47 disposing of 101 keys 69–71 preferences 72–75 screens 80 troubleshooting 92–94 Positron Emission Tomography (PET) scans 122 Power tools 31 Power/Backlight key 69, 71 Precautions 26–31 Preference icons 72 Preferences, changing 72–75 English 7439 2004-08 Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 7439IX.fm 10/13/04 9:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Index Pregnancy 32 Programmer See Patient programmer Programs description 38–39 navigating 63 Psychotherapeutic procedures 119 Pulse width description 38 increasing or decreasing 62–65 Radiation therapy 119 Radiofrequency (RF) ablation 113 Rate description 38 in programs and group 63 increasing or decreasing 62–65 Scuba diving 30 Security devices 114 Serial number 95 Settings, adjusting stimulation 57–65 Skiing 30 Skydiving 30 SoftStart/Stop 90 Specifications 103 Status row 49, 72 Status row icons 50 7439 2004-08 English 221244001 Rev X Printing instructions: 133 Index 7439IX.fm 10/13/04 9:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 134 221244001 Medtronic Confidential NeuroPatntR00 Stimulation adjusting settings 57–65 description 34 guidelines for adjusting 53–55 troubleshooting 89–91 uncomfortable 56, 89 unexpected 56 unexpected changes 30, 54 Sync key 49, 70 Synchronizing 48 Theft detectors 114 Therapy screen 48, 49 Therapy screen icons 49 Tones, audio 57, 80 Transcutaneous electrical nerve stimulation (TENS) 119 Turning neurostimulator ON or OFF 55 Twiddler’s Syndrome 29 Ultrasonic probes 116 Ultrasonics, high-output 111 Ultrasound 121 Uncomfortable stimulation preventing 56 troubleshooting 89 Unexpected changes in stimulation 30, 54 Unexpected stimulation, preventing 56 Upper limit screens 65 Warning screens 80–82 Warnings 19–26 X-rays 122 English 7439 2004-08 Rev X Printing instructions: 7439_bcv.fm 10/13/04 9:31 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 221244001 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: 7439_bcv.fm 10/13/04 9:31 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. *221244001* 221244001 Rev X © Medtronic, Inc. 2004 All Rights Reserved 221244001 Printing instructions:
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