Medtronic 37021 External Neurostimulator (ENS) User Manual Patient manual

Medtronic, Inc. External Neurostimulator (ENS) Patient manual

Users Manual Revised

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. Writer Suzanne Dawidowicz Date 19 August 2004 Part No. Part No. Rev Comments A01560004 A 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. Page 1 Form MEDN-0043 version 6.0 1. Materials: Covers • Grade #1, 80 lb. white gloss coated cover stock, minimum brightness level: 89 Text • 60 lb. white smooth opaque text stock Labels • N/A 2. Colors: To confirm all colors, graphics and text, refer to electronic file Front Cover • 4-color cover and solid gloss varnish Back Cover • Black text and graphics; solid gloss varnish Body • 2-color text and graphics (PMS 301, black, percentages of PMS 301 or percentages of black) Labels • N/A 3. Size: 4.6″ ± 0.2 (w) x 6.0″ ± 0.2 (h) 4. Type of Binding: Clear plastic coil, MWE lay-flat, or perfect bound 5. Other: • Cover and text whiteness must match visually. 6. Literature Piece Page Count (Including covers, excluding this form): 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.
37021_FC.fm 8/19/04 8:31 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00EXTERNAL NEUROSTIMULATOR 37021Test stimulation patient guide Rx only
37021_FC.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00Medtronic® and Restore™ are trademarks of Medtronic, Inc. FCC InformationThe following is communications regulation information on the Model 37021 external neurostimulator.FCC ID: LF537021This device complies with Part 15 Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation.IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., could void the FCC Certification and negate your authority to operate this product.
Printing instructions: 37021_TOC.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X37021 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Contents3ContentsLabel symbols 51 Introduction 7Purpose of the device 8Precautions 9How to use this guide 9Test stimulation overview 10Test stimulation goals 11Patient guides 122 Using your test stimulationsystem 13Knowing your system components 14Using your external neurostimulator and accessories 16Using the external neurostimulator holder 16Checking the external neurostimulator batteries 18Replacing the external neurostimulator batteries 19Using the THERAPY-STOP key 23
A01560004 Rev X37021_TOC.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37021 2004-08Medtronic ConfidentialNeuroPatntR00Contents4Reconnecting the cable to the external neurostimulator 23Specifications 25Declaration of Conformity 273 Your daily activities 29What you should know about your activities 30Device care 30Physical activities 31Incision care 33Sleeping 34What changes in sensation to expect during test stimulation 34Index 36
Printing instructions: 37021_Sym.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X37021 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Label symbols5Label symbolsExplanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply.CE0123Conformité Européenne (European Conformity). This symbol means that the device fully complies with 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.System meets the applicable Canadian [C22.2-601.1-M90 (R2001)] electrical safety standard requirements.yIEC 60601-1/EN60601-1, Type BF EquipmentwCaution, consult accompanying documentsLNon-ionizing electromagnetic radiationFor USA audiences only
A01560004 Rev X37021_Sym.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37021 2004-08Medtronic ConfidentialNeuroPatntR00Label symbols6
37021_Ch01.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR001Introduction
37021_Ch01.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00English 37021 2004-08Introduction 18Purpose of the deviceThe 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. 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.
Printing instructions: 37021_Ch01.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X37021 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Introduction 19PrecautionsWhen 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 guideFor 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.
A01560004 Rev X37021_Ch01.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37021 2004-08Medtronic ConfidentialNeuroPatntR00Introduction 110This 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.Test stimulation overviewYour 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
Printing instructions: 37021_Ch01.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X37021 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Introduction 111determine 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 goalsThe goals of a test stimulation are to determine:•If stimulation covers your body's painful areas•If you are comfortable with the sensation of stimulation•If you can use the patient programmer to control your stimulation
A01560004 Rev X37021_Ch01.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37021 2004-08Medtronic ConfidentialNeuroPatntR00Introduction 112Patient guidesIn 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.Review these materials and keep themin a convenient place during test stimulation.
37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR002 Using your test stimulationsystem
37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00English 37021 2004-08Using your test stimulation system 214Knowing your system componentsFor test stimulation, your clinician will provide you with the following components:•External neurostimulator–Two AA alkaline batteries (LR6)a•Snap-lid connector cable (cable)•Patient programmer–Two AAA alkaline batteries (LR03)a•External neurostimulator holder with belt clipaYou may need to replace batteries during test stimulation; have extra batteries available.
Printing instructions: 37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X37021 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your test stimulation system 215Figure 2.1 Test stimulation system components.Patient programmerExternal neurostimulatorHolder with belt clipLead or extensionSnap-lid connector cable (cable)
A01560004 Rev X37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37021 2004-08Medtronic ConfidentialNeuroPatntR00Using your test stimulation system 216Using your external neurostimulator and accessoriesThis section provides you with the instructions for:•Using the external neurostimulator holder•Checking the external neurostimulator batteries•Replacing the external neurostimulator batteries•Using the THERAPY-STOP key•Reconnecting the cable to the external neurostimulatorUsing the external neurostimulator holderUse 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).
Printing instructions: 37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X37021 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your test stimulation system 217Note: A belt with device pouches is available as an option. Refer to the instructions provided with the belt for additional information.Figure 2.2 Slide the external neurostimulator holder over your belt or garment.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.ba
A01560004 Rev X37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37021 2004-08Medtronic ConfidentialNeuroPatntR00Using your test stimulation system 2183. Place the external neurostimulator into the holder with the red THERAPY-STOP key facing out (Figure 2.4).Figure 2.4 Place the external neurostimulatorinto the holder.Checking the external neurostimulator batteriesUse 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. THERAPY-STOP key
Printing instructions: 37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X37021 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your test stimulation system 219If 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.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.Replacing the external neurostimulator batteriesCautions:–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
A01560004 Rev X37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37021 2004-08Medtronic ConfidentialNeuroPatntR00Using your test stimulation system 220history is no longer available, and the stimulation settings may not reflect recent programming changes.–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. 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
Printing instructions: 37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X37021 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your test stimulation system 221stimulation and may require surgery to replace the lead.4. Press down lightly on the battery compartment cover (Figure 2.5a). Figure 2.5 Open the battery compartment cover.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).bac
A01560004 Rev X37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37021 2004-08Medtronic ConfidentialNeuroPatntR00Using your test stimulation system 2227. 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.)9. Place the external neurostimulator into the holder.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.
Printing instructions: 37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X37021 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your test stimulation system 223Using the THERAPY-STOP keyTypically, 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.Figure 2.6 Use the THERAPY-STOP key to immediately turn stimulation OFF.Reconnecting the cable to the external neurostimulatorIf the cable plug is disconnected from the external neurostimulator, stimulation will stop.
A01560004 Rev X37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37021 2004-08Medtronic ConfidentialNeuroPatntR00Using your test stimulation system 2241. 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).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.Figure 2.7 Insert the plug into the output jack.2. Use your patient programmer to turn stimulation ON.
Printing instructions: 37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X37021 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your test stimulation system 225SpecificationsTable 2.1 External neurostimulator specificationsItem SpecificationPower source 2 AA alkaline batteries (non-rechargable, LR6)Battery life 144 hours minimum (21 days average) for alkaline batteriesOperating 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)10% to 95% (storage)Operating atmospheric pressure700 hPa to 1060 hPa(20.7 in. Hg to 31.3 in. Hg)Storage atmospheric pressure700 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.)
A01560004 Rev X37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37021 2004-08Medtronic ConfidentialNeuroPatntR00Using your test stimulation system 226Weight, including batteriesApproximately 100 g (3.5 oz.)Mode of operation ContinuousCase material Polycarbonate/ABS blend plastic resinExternal neurostimulator automatically shuts OFFa when:•Device detects moisture•Battery door opens•Snap-lid connector cable is not connected•Snap-lid connector opensaUse the patient programmer to turn the external neurostimulator ON when the condition is resolved.Table 2.1 External neurostimulator specifications (continued)Item Specification
Printing instructions: 37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X37021 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Using your test stimulation system 227Declaration of ConformityMedtronic 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.For additional information, contact the appropriate Medtronic representative listed on the inside back cover of this manual
A01560004 Rev X37021_Ch02.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37021 2004-08Medtronic ConfidentialNeuroPatntR00Using your test stimulation system 228
37021_Ch03.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR003 Your daily activities
37021_Ch03.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00English 37021 2004-08Your daily activities 330What you should know about your activitiesTo 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.Device care•Keep fresh batteries available.•Use the patient programmer daily to check the external neurostimulator batteries.•Replace low or depleted batteries.
Printing instructions: 37021_Ch03.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X37021 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Your daily activities 331•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. Physical activitiesTo 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.
A01560004 Rev X37021_Ch03.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37021 2004-08Medtronic ConfidentialNeuroPatntR00Your daily activities 332•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 'log-rolling' 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.•Avoid lifting more than 2.3 kilograms (5 pounds).•Talk to your doctor about when it is appropriate for you to resume sexual activity.
Printing instructions: 37021_Ch03.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X37021 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Your daily activities 333Incision 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–Pus–Redness
A01560004 Rev X37021_Ch03.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37021 2004-08Medtronic ConfidentialNeuroPatntR00Your daily activities 334Sleeping•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 stimulationThe sensation of stimulation is different from person to person. Most people report a steady, tingling sensation in the area of their pain.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
Printing instructions: 37021_Ch03.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X37021 2004-08 EnglishMedtronic ConfidentialNeuroPatntR00Your daily activities 335further 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.If you use the red THERAPY-STOP key, you must use the patient programmer to turn your stimulation ON again.
A01560004 Rev X37021_IX.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENPrinting instructions: English 37021 2004-08Medtronic ConfidentialNeuroPatntR03Index36IndexActivities 31Batteries, external neurostimulatorchecking 18precaution 9replacing 19Battery level 18Cable, reconnecting to external neurostimulator 23Caring for your device 30Caring for your incision 33Cleaning device 31Components 14External neurostimulatorbatterieschecking 18precaution 9replacing 19cable, reconnecting 23description 8holder 16Holder 16Incision care 33Patient programmerchecking external neurostimulator battery 18typical use 23Precautions 9Sensation of stimulation 34Sleeping 34Specifications 25
Printing instructions: 37021_IX.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X37021 2004-08 EnglishMedtronic ConfidentialNeuroPatntR03Index37System components 14Test stimulationgoals 11overview 10THERAPY-STOP key 23Turning stimulation OFF immediately 23
37021_IX.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR03
37021_bcv.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X Printing instructions: Medtronic ConfidentialNeuroPatntR00Contacts:Asia: Medtronic International Ltd. Suite 1602 16/F, Manulife Plaza,The Lee Gardens, 33 Hysan Avenue,Causeway Bay, Hong KongTel. 852-2891-4068 Fax 852-2591-0313Medtronic Asia Ltd.3 Floor Peter Building,570-6 Shinsa-Dong Kangnam-ku,Seoul 135-120, South KoreaTel. 82-2-548-1148 Fax 82-2-518-4786Australia: Medtronic Australasia Pty. Ltd.Unit 4/446 Victoria Road, Gladesville NSW 2111Tel. 02-9879-5999 Fax 02-9879-5100Austria: Medtronic Österreich G.m.b.H.Millennium Tower, Handelskai 94-96, 1200 ViennaTel. 01-24044 Fax 01-24044-100Belgium: Medtronic Belgium S.A.Boechoutlaan 55, 1853 Strombeek-BeverTel. 02-456-0900 Fax 02-460-2667Canada: Medtronic of Canada Ltd.6733 Kitimat Road, Mississauga,Ontario L5N 1W3Tel. 905-826-6020 Fax 905-826-6620 Denmark: Medtronic-ViCare A/SBirkerød Kongevej 150B, DK-3460 BirkerødTel. 45-823366 Fax 45-823365Finland: Medtronic Finland OY/LTDSahaajankatu 24, P.O. Box 230FIN-00810 Helsinki Tel. 9-755-2500 Fax 9-755-25018France: Medtronic France S.A.S.122, avenue du Général Leclerc, 92514 Boulogne-Billancourt CedexTel. 01-5538-1700 Fax 01-5538-1800Germany: Medtronic GmbHEmanuel-Leutze-Straße 20, 40547 Düsseldorf, P.O. Box 110738Tel. 0211-52930 Fax 0211-5293100Greece: Medtronic Hellas S.A.Agias Varvaras 5, 15231 Halandri, AthensTel. +30 2 10-677 90 99 Fax 30 2 10-677 93 99Italy: Medtronic Italia SpAP.zza Indro Montanelli 30,20099 Sesto San Giovanni (MI).Tel. 02-241371. Fax 02-241381.Via Lucrezio Caro, 63, 00193 RomaTel. 06-328141 Fax 06-3215812Japan: Medtronic JapanSolid Square West Tower 6F,580 Horikawa-cho, Saiwai-ku,Kawasaki, Kanagawa 210-0913.Tel. 044-540-6112 Fax 044-540-6200Latin America Headquarters: Medtronic, Inc.710 Medtronic Parkway,Minneapolis, MN 55432-5604 USATel. 763-514-4000 Fax 763-514-4879The Netherlands: Medtronic B.V.Earl Bakkenstraat 10, P.O.Box 2542, 6401 DA HeerlenTel. 045-5668000 Fax 045-5668668Norway: Medtronic Vingmed ASFjordveien 1, Postboks 366, 1323 HøvikTel. 67 58 06 80 Fax 67 10 12 12Portugal: Medtronic Portugal, Lda.Rua Tomás da Fonseca,Torre E 8, andar A,B,1600 - 209 LisboaTel.21-724-5100 Fax 21-724-5199Spain: Medtronic Ibérica, S.A.Centro Empresarial Miniparc III, Edificio K,Calle Caléndula, 93, El Soto de la Moraleja,28109 Alcobendas - MadridTel. 91-625-0400 Fax 91-650-7410Sweden: Medtronic ABDackevägen 33, Box 265S-177 25 JärfällaTel. 08-5222-0000 Fax 08-5222-0050Internet: www.medtronic.seSwitzerland: Medtronic (Schweiz) AGRoute du Molliau 31Case Postale 84CH-1131 TolochenazTel. 021-803-8000 Fax 021-803-8099U.K. and Ireland: Medtronic U.K. Ltd.Suite 1, Sherbourne House, Croxley Business Center, Watford,Herts WD1 8YE, United KingdomTel. 1923-212213 Fax 1923-241004USA: Medtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432-5604USATel. 763-505-0606Toll-free: 1-800-707-0933Fax 763-505-0130
37021_bcv.fm 8/19/04 8:32 amSize 4.625" x 6.0" (117 mm x 152 mm)UC200xxxxxx ENA01560004 Rev X Printing instructions: *A01560004*© Medtronic, Inc. 2004All Rights ReservedA01560004Medtronic ConfidentialNeuroPatntR00ManufacturerMedtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432-5604USAInternet: www.medtronic.comTel. 1-763-505-5000Fax 1-763-505-1000Medtronic E.C. Authorized Representative/Distributed byMedtronic B.V.Earl Bakkenstraat 106422 PJ HeerlenThe NetherlandsTel. 31-45-566-8000Fax 31-45-566-8668Europe/Africa/Middle East HeadquartersMedtronic Europe SàrlRoute du Molliau 31Case PostaleCH-1131 TolochenazSwitzerlandInternet: www.medtronic.co.ukTel. 41-21-802-7000Fax 41-21-802-7900Asia-PacificMedtronic International Ltd.Suite 1602 16/F, Manulife Plaza The Lee Gardens, 33 Hysan AvenueCauseway BayHong KongTel. 852-2891-4068Fax 852-2591-0313Contacts for specific countries are listed inside this cover.

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