Medtronic 37021 External Neurostimulator (ENS) User Manual Patient manual
Medtronic, Inc. External Neurostimulator (ENS) Patient manual
Users Manual Revised
| Download: |  |
| Mirror Download [FCC.gov] | |
| Document ID | 537746 |
| Application ID | 0v5kpLxNdcZwRDvcm+JU0g== |
| Document Description | Users Manual Revised |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 54.57kB (682072 bits) |
| Date Submitted | 2005-04-29 00:00:00 |
| Date Available | 2005-04-29 00:00:00 |
| Creation Date | 2004-08-19 13:32:11 |
| Producing Software | Acrobat Distiller 5.0.5 (Windows) |
| Document Lastmod | 2005-04-22 11:24:44 |
| Document Title | Patient manual |
| Document Creator | PScript5.dll Version 5.2 |
Neurological Medtronic Confidential Title Model 37021 ENS Test Stimulation Patient Guide 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. A01560004 Writer Suzanne Dawidowicz Date 19 August 2004 Part No. Rev Comments Release for US/OUS Market Release Submissions 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): 40 7. Note to print supplier: Supplier may add up to three blank pages at the end of the document before the back cover sheet as needed. If more are required, contact the purchasing agent. 8. Vendor-supplied information may appear at an appropriate location on the literature piece (eg, part number, bar code, etc.). 9. Graphics Content and Layout to be as shown and per Medtronic electronic file that is supplied (stored) by Medtronic Neuro. Page 1 Form MEDN-0043 version 6.0 37021_FC.fm 8/19/04 8:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 EXTERNAL NEUROSTIMULATOR Test stimulation patient guide Rx only A01560004 Rev X Printing instructions: 37021 37021_FC.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Medtronic® and Restore™ are trademarks of Medtronic, Inc. FCC Information The following is communications regulation information on the Model 37021 external neurostimulator. FCC ID: LF537021 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. A01560004 Rev X Printing instructions: 37021_TOC.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Contents Label symbols 1 Introduction Purpose of the device 8 Precautions 9 How to use this guide 9 Test stimulation overview 10 Test stimulation goals 11 Patient guides 12 2 Using your test stimulation system 13 Using the external neurostimulator holder 16 Checking the external neurostimulator batteries 18 Replacing the external neurostimulator batteries 19 Using the THERAPY-STOP key 23 37021 2004-08 English A01560004 Rev X Printing instructions: Contents Knowing your system components 14 Using your external neurostimulator and accessories 16 37021_TOC.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Reconnecting the cable to the external neurostimulator 23 Specifications 25 Declaration of Conformity 27 3 Your daily activities 29 What you should know about your activities 30 Device care 30 Physical activities Incision care 33 Sleeping 34 31 What changes in sensation to expect during test stimulation 34 36 Contents Index A01560004 English 37021 2004-08 Rev X Printing instructions: 37021_Sym.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Label symbols Explanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply. CE 0123 Conformité Européenne (European Conformity). This symbol means that the device fully complies with MDD 93/42/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. IEC 60601-1/EN60601-1, Type BF Equipment Caution, consult accompanying documents Non-ionizing electromagnetic radiation For USA audiences only 37021 2004-08 English A01560004 Rev X Printing instructions: Label symbols System meets the applicable Canadian [C22.2-601.1-M90 (R2001)] electrical safety standard requirements. Medtronic Confidential NeuroPatntR00 Label symbols 37021_Sym.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN A01560004 English 37021 2004-08 Rev X Printing instructions: 37021_Ch01.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 1 Introduction A01560004 Rev X Printing instructions: 37021_Ch01.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Purpose of the device Introduction 1 The Model 37021 external neurostimulator is designed to evaluate the success of Medtronic neurostimulation systems for pain therapy prior to implant. The external neurostimulator provides the same output characteristics as the Medtronic Restore Neurostimulation System for Pain Therapy. A01560004 The Medtronic neurostimulation system is intended to provide electrical stimulation to relieve severe, intractable pain. The Medtronic neurostimulation system for pain therapy indications, contraindications, risks and benefits, warnings, precautions, and individualization of treatment information are located in the Model 37742 Patient Programmer: Pain Therapy User Manual. English 37021 2004-08 Rev X Printing instructions: 37021_Ch01.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Precautions When operating an external neurostimulator, 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. How to use this guide Introduction 1 For over 30 years, stimulation has helped thousands of patients manage their pain and improve their quality of life. Test stimulation will determine if stimulation is helpful for you. Stimulation will not cure your pain. It may, however, reduce your pain to a tolerable level. As a result, you may be able to resume your daily activities. 37021 2004-08 English A01560004 Rev X Printing instructions: 37021_Ch01.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 This guide includes the following information: • Chapter 1, “Introduction,” provides an overview and goals of test stimulation. • Chapter 2, “Using your test stimulation system,” describes how to use your external neurostimulator. • Chapter 3, “Your daily activities,” gives recommendations regarding your daily activities during test stimulation. Ask your doctor to explain anything that is unclear. Introduction 1 Test stimulation overview 10 A01560004 Your pain is unique to you. Because pain relief can only be evaluated by you, your doctor has prescribed a test stimulation period. Test stimulation is designed to help you and your doctor evaluate the benefits of stimulation for managing your pain. Some doctors may prescribe three to five days for test stimulation; others may prescribe more days. Your doctor will English 37021 2004-08 Rev X Printing instructions: 37021_Ch01.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 determine the number of days that is best for you. Test stimulation allows you to experience stimulation during your daily activities. Your doctor may ask you to keep a log of how you feel at different times during the day. The log helps your doctor determine if the stimulation is effective for managing your pain. If you experience adequate pain relief during test stimulation and you are comfortable using the system, your doctor may decide to implant a neurostimulation system. Test stimulation goals The goals of a test stimulation are to determine: • If you are comfortable with the sensation of stimulation • If you can use the patient programmer to control your stimulation 37021 2004-08 English A01560004 Rev X Printing instructions: Introduction 1 • If stimulation covers your body's painful areas 11 37021_Ch01.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Patient guides In addition to the information contained in this guide, your clinician should have provided you with the following patient materials: • Medtronic Model 37742 Patient Programmer: Pain Therapy User Manual. This manual provides an overview of how stimulation works, a detailed description of how to use your patient programmer, and troubleshooting steps. • Medtronic Model 37742 Patient Programmer: Quick Reference Guide. This guide provides basic, step-by-step instructions on how to use your patient programmer. Introduction 1 Review these materials and keep them in a convenient place during test stimulation. 12 A01560004 English 37021 2004-08 Rev X Printing instructions: 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 2 Using your test stimulation system A01560004 Rev X Printing instructions: 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Knowing your system components For test stimulation, your clinician will provide you with the following components: • External neurostimulator – Two AA alkaline batteries (LR6)a • Snap-lid connector cable (cable) Using your test stimulation system 2 • Patient programmer 14 A01560004 – Two AAA alkaline batteries (LR03)a • External neurostimulator holder with belt clip You may need to replace batteries during test stimulation; have extra batteries available. English 37021 2004-08 Rev X Printing instructions: 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 External neurostimulator Patient programmer Holder with belt clip Snap-lid connector cable (cable) Figure 2.1 Test stimulation system components. 37021 2004-08 English A01560004 Rev X Printing instructions: Using your test stimulation system 2 Lead or extension 15 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Using your external neurostimulator and accessories This section provides you with the instructions for: • Using the external neurostimulator holder • Checking the external neurostimulator batteries • Replacing the external neurostimulator batteries Using your test stimulation system 2 • Using the THERAPY-STOP key 16 A01560004 • Reconnecting the cable to the external neurostimulator Using the external neurostimulator holder Use the external neurostimulator holder to carry the external neurostimulator on your belt or garment. 1. Slide the external neurostimulator holder over your belt or garment (Figure 2.2). English 37021 2004-08 Rev X Printing instructions: 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Note: A belt with device pouches is available as an option. Refer to the instructions provided with the belt for additional information. 2. With the triangles on the cable plug and the external neurostimulator pointing toward each other (Figure 2.3), gently insert the plug fully into the output jack. Figure 2.3 Insert the plug into the output jack. 37021 2004-08 English A01560004 Rev X Printing instructions: Using your test stimulation system 2 Figure 2.2 Slide the external neurostimulator holder over your belt or garment. 17 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 3. Place the external neurostimulator into the holder with the red T HERAPY-STOP key facing out (Figure 2.4). THERAPY-STOP key Using your test stimulation system 2 Figure 2.4 Place the external neurostimulator into the holder. 18 A01560004 Checking the external neurostimulator batteries Use your patient programmer to check your external neurostimulator battery level every day. For instructions on checking the external neurostimulator battery level, refer to the manual packaged with the patient programmer. English 37021 2004-08 Rev X Printing instructions: 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 If the external neurostimulator batteries need immediate replacement, the patient programmer will display an information or warning screen. Information and warning screens are described in the Troubleshooting section of the manual packaged with your patient programmer. Replacing the external neurostimulator batteries Cautions: – When replacing batteries during test stimulation, insert the new batteries within 15 minutes of removing the old batteries. If the batteries are not replaced within 15 minutes, the neurostimulator may reset. When a neurostimulator resets, stimulation 37021 2004-08 English A01560004 Rev X Printing instructions: Using your test stimulation system 2 If test stimulation lasts seven days or less, you should not need to replace your batteries. Battery usage depends on your specific therapy settings and length of test stimulation. 19 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 history is no longer available, and the stimulation settings may not reflect recent programming changes. Using your test stimulation system 2 – Before installing batteries, always decrease all amplitudes to the lowest setting, turn OFF the external neurostimulator and then disconnect the cable from the external neurostimulator to prevent possible uncomfortable or unexpected stimulation (jolting or shocking sensation) when stimulation is turned ON. 20 A01560004 1. Use your patient programmer to decrease all amplitudes and turn OFF the external neurostimulator. 2. Remove the external neurostimulator from the holder. 3. Gently pull the cable plug from the output jack. Caution: Do not pull on the cable. Pulling on the cable may break a wire or dislodge the lead. A broken wire or dislodged lead may result in loss of English 37021 2004-08 Rev X Printing instructions: 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 stimulation and may require surgery to replace the lead. 4. Press down lightly on the battery compartment cover (Figure 2.5a). 5. Push the cover in the direction of the arrow, then swing the cover open (Figure 2.5b, c). 6. Remove the depleted batteries and insert two new AA alkaline batteries into the battery compartment (Figure 2.5c). Note: Match the battery polarity to the positive (+) and negative (–) markings on the inside of the battery compartment cover (Figure 2.5c). 37021 2004-08 English A01560004 Rev X Printing instructions: Using your test stimulation system 2 Figure 2.5 Open the battery compartment cover. 21 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 7. Push down the battery compartment cover until it clicks into position. Then slide the cover back in the opposite direction of the arrow until it closes. 8. Reconnect the cable. (For detailed instructions, see “Reconnecting the cable to the external neurostimulator” on page 23.) Using your test stimulation system 2 9. Place the external neurostimulator into the holder. 22 A01560004 Note: After the batteries are installed and the battery compartment cover is closed, stimulation may not be available for up to 60 seconds. 10. Use the patient programmer to turn ON your external neurostimulator. 11. Dispose of depleted batteries according to local requirements. English 37021 2004-08 Rev X Printing instructions: 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Using the THERAPY-STOP key Figure 2.6 Use the THERAPY-STOP key to immediately turn stimulation OFF. Reconnecting the cable to the external neurostimulator If the cable plug is disconnected from the external neurostimulator, stimulation will stop. 37021 2004-08 English A01560004 Rev X Printing instructions: Using your test stimulation system 2 Typically, you will use the patient programmer to turn stimulation OFF. However, if you need to turn stimulation OFF immediately, press the red THERAPY-STOP key (Figure 2.6). You must use the patient programmer to turn the external neurostimulator ON again. 23 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 1. With the triangles on the cable plug and the external neurostimulator pointing toward each other, gently insert the plug fully into the output jack (Figure 2.7). Using your test stimulation system 2 Caution: Do not pull on the cable. Pulling on the cable may break a wire or dislodge the lead. A broken wire or dislodged lead may result in loss of stimulation and may require surgery to replace the lead. 24 A01560004 Figure 2.7 Insert the plug into the output jack. 2. Use your patient programmer to turn stimulation ON. English 37021 2004-08 Rev X Printing instructions: 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Specifications Item Specification Power source 2 AA alkaline batteries (non-rechargable, LR6) Battery life 144 hours minimum (21 days average) for alkaline batteries Operating temperature +10°C to +44°C (+50°F to +111°F) Storage temperature –40°C to +65°C (–40°F to +149°F) Relative humidity 30% to 75% (operating) Operating atmospheric pressure 700 hPa to 1060 hPa (20.7 in. Hg to 31.3 in. Hg) Storage atmospheric pressure 700 hPa to 1060 hPa (20.7 in. Hg to 31.3 in. Hg) Size Approximately 8.9 x 5.4 x 2.8 cm (3.5 in. x 2.1 in. x 1.1 in.) 10% to 95% (storage) 37021 2004-08 English A01560004 Rev X Printing instructions: Using your test stimulation system 2 Table 2.1 External neurostimulator specifications 25 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Table 2.1 External neurostimulator specifications (continued) Item Specification Weight, including batteries Approximately 100 g (3.5 oz.) Mode of operation Continuous Case material Polycarbonate/ABS blend plastic resin External neurostimulator automatically shuts OFFa when: Using your test stimulation system 2 • Device detects moisture 26 A01560004 • Battery door opens • Snap-lid connector cable is not connected • Snap-lid connector opens Use the patient programmer to turn the external neurostimulator ON when the condition is resolved. English 37021 2004-08 Rev X Printing instructions: 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Declaration of Conformity Medtronic declares that this product is in conformity with the essential requirements of Directive 1999/5EC on Radio and Telecommunications Terminal Equipment and Directive 93/42/EEC on Medical Devices. Using your test stimulation system 2 For additional information, contact the appropriate Medtronic representative listed on the inside back cover of this manual 37021 2004-08 English A01560004 Rev X Printing instructions: 27 Medtronic Confidential NeuroPatntR00 Using your test stimulation system 2 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 28 A01560004 English 37021 2004-08 Rev X Printing instructions: 37021_Ch03.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 3 Your daily activities A01560004 Rev X Printing instructions: 37021_Ch03.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 What you should know about your activities To reduce the risk of moving your implanted lead(s) after surgery, always follow your clinician’s instructions during test stimulation. Read and understand this patient guide and the other patient materials about your system. Keep a record of your stimulation parameter settings, daily activities, and pain relief. Your daily activities 3 Device care 30 A01560004 • Keep fresh batteries available. • Use the patient programmer daily to check the external neurostimulator batteries. • Replace low or depleted batteries. English 37021 2004-08 Rev X Printing instructions: 37021_Ch03.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • Do not pull on the cable or lead. • Keep the device out of the reach of children. • 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. To reduce the risk of moving your implanted lead(s), always follow your clinician’s instructions and these guidelines: • Limit your physical activities to low or moderate levels. • Avoid reaching over your head. 37021 2004-08 English A01560004 Rev X Printing instructions: Your daily activities 3 Physical activities 31 37021_Ch03.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 • Avoid turning side to side. • Avoid climbing too many stairs. • Avoid sitting in a chair for a long period of time. • Avoid sudden, rapid movements such as twisting, stretching, or bending. Note: You can move your body in bed without twisting by moving your shoulders and hips at the same time with a 'logrolling' movement. Ask your clinician to teach this movement to you while you are in the hospital. • Avoid bending forward, backward, or from side to side. Your daily activities 3 • Avoid lifting more than 2.3 kilograms (5 pounds). 32 A01560004 • Talk to your doctor about when it is appropriate for you to resume sexual activity. English 37021 2004-08 Rev X Printing instructions: 37021_Ch03.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Incision care • Keep your incision site(s) dry by taking sponge baths instead of showers to help avoid infections. • Follow your clinician's instructions about cleaning the incision site(s) or changing dressings. • Follow your clinician's advice about managing your incision pain. • Call your clinician if you notice any of these signs of an infection: – Increased pain in your incision – Fever – Chills Your daily activities 3 – Pus – Redness 37021 2004-08 English A01560004 Rev X Printing instructions: 33 37021_Ch03.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Sleeping • Do not sleep on your stomach. • Sleep on your back or on the side opposite the device. • Use a firm mattress that supports your legs and back equally. What changes in sensation to expect during test stimulation Your daily activities 3 The sensation of stimulation is different from person to person. Most people report a steady, tingling sensation in the area of their pain. 34 A01560004 Generally, people experience a constant sensation of stimulation. However you may feel some normal stimulation changes when you suddenly move or change position. Some movements, such as leaning back, may cause the lead to move closer to your spinal cord. These movements can increase your sensation of stimulation. Other movements may cause the lead to move English 37021 2004-08 Rev X Printing instructions: 37021_Ch03.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 further away from your spinal cord. These movements may decrease your sensation of stimulation. Typically, you will use the patient programmer to turn stimulation OFF. However, if you feel a sudden and unpleasant change in stimulation, press the red THERAPY-STOP key on your external neurostimulator to turn OFF the stimulation immediately. Your daily activities 3 If you use the red THERAPY-STOP key, you must use the patient programmer to turn your stimulation ON again. 37021 2004-08 English A01560004 Rev X Printing instructions: 35 37021_IX.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Index Index 36 A01560004 Activities 31 Batteries, external neurostimulator checking 18 precaution 9 replacing 19 Battery level 18 Cable, reconnecting to external neurostimulator 23 Caring for your device 30 Caring for your incision 33 Cleaning device 31 Components 14 External neurostimulator batteries checking 18 precaution 9 replacing 19 cable, reconnecting 23 description 8 holder 16 Holder 16 Incision care 33 Patient programmer checking external neurostimulator battery 18 typical use 23 Precautions 9 Sensation of stimulation 34 Sleeping 34 Specifications 25 English 37021 2004-08 Rev X Printing instructions: 37021_IX.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Index System components 14 Test stimulation goals 11 overview 10 THERAPY-STOP key 23 Turning stimulation OFF immediately 23 37021 2004-08 English A01560004 Rev X Printing instructions: 37 37021_IX.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN A01560004 Rev X Medtronic Confidential NeuroPatntR03 Printing instructions: 37021_bcv.fm 8/19/04 8:32 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 A01560004 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: 37021_bcv.fm 8/19/04 8:32 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. *A01560004* A01560004 Rev X © Medtronic, Inc. 2004 All Rights Reserved A01560004 Printing instructions:
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.5 Linearized : No Page Count : 41 Page Mode : UseOutlines Has XFA : No XMP Toolkit : XMP toolkit 2.9.1-13, framework 1.6 About : uuid:efb86a5b-abda-4e41-bf74-690858a93747 Producer : Acrobat Distiller 5.0.5 (Windows) Create Date : 2004:08:19 13:32:11Z Modify Date : 2005:04:22 11:24:44-05:00 Metadata Date : 2005:04:22 11:24:44-05:00 Creator Tool : PScript5.dll Version 5.2 Document ID : uuid:940d474d-d872-4c0e-98bb-d704e174cc07 Format : application/pdf Creator : Title : Patient manual Description : Model xxxx, xxxx, and xxxx, Author : Keywords : Model xxxx, xxxx, and xxxx, UC200xxxxxx EN, A01560-004 Subject : Model xxxx, xxxx, and xxxx,EXIF Metadata provided by EXIF.tools