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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.

O NOT COUNT THIS FORM IN THE LITERATURE PIECE PAGE COUNT.

EVISION 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.

Summary of content (41 pages)

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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.
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37021_FC.fm 8/19/04 8:31 am Size 4.625" x 6.
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7021_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.
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37021_TOC.fm 8/19/04 8:32 am Size 4.625" x 6.
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37021_TOC.fm 8/19/04 8:32 am Size 4.625" x 6.
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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.
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Medtronic Confidential NeuroPatntR00 Label symbols 37021_Sym.fm 8/19/04 8:32 am Size 4.625" x 6.
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37021_Ch01.fm 8/19/04 8:32 am Size 4.625" x 6.
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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.
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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.
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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.
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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.
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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.
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37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.
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37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.
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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.
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37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.
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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. a b Figure 2.3 Insert the plug into the output jack.
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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.
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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.
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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.
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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). a b c 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).
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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.
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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.
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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.
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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.
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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.
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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.
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Medtronic Confidential NeuroPatntR00 Using your test stimulation system 2 37021_Ch02.fm 8/19/04 8:32 am Size 4.625" x 6.
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37021_Ch03.fm 8/19/04 8:32 am Size 4.625" x 6.
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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.
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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.
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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.
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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.
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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.
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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.
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021_IX.fm 8/19/04 8:32 am Size 4.625" x 6.
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37021_IX.fm 8/19/04 8:32 am Size 4.625" x 6.
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37021_IX.fm 8/19/04 8:32 am Size 4.625" x 6.
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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.
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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.