FCC ID: LF537751 Patient Recharge System (INSR)

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. A08366001 Part No. Rev A Neurological Medtronic Confidential Title Model 37751 INSR patient manual Writer Theresa King-Hunter Date 24 August 2004 Global market release Comments 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 4.6 0.2 (w) x 6.0 0.2 (h) 3. Size:

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):

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. 86 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 PatntFC.fm 8/23/04 7:57 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 RECHARGER Charging System user manual 37751 c Rx Only 2005 A08366001 Rev X Printing instructions:

PatntFC.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Medtronic, Restore, and SoftStart are trademarks of Medtronic, Inc. c FCC Information The following is communications regulation information on the Model 37751 Patient Programmer. FCC ID: LF537751 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. A08366001 Rev X Printing instructions:

PatntTOC.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Contents 1 9 6 Label symbols Introduction Purpose of the device 10 Warnings 10 Precautions 11 How to use this manual 13 Parts of your charging system 15 How your charging system works 17 Recharger keys and screens 19 Recharger keys 19 Recharger screens 21 2 Using your charging system 25 Battery and charging information 26 Recharger and Neurostimulator 26 Recharger 27 Neurostimulator 28 Neurostimulator battery status 29 Charging your neurostimulator battery 32 37751 03/2005 English A08366001 Rev X Printing instructions:

s t n e n o C t 3 PatntTOC.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Turning the neurostimulator ON and OFF while charging 39 Accessories 41 Using the recharger pouch 41 Using the charging system carrying case 41 3 Troubleshooting Identification label 41 43 Recharger screens 44 Warning screens 44 Information screens 49 Possible problems and solutions 56 User assistance 63 65 4 Maintenance Recharger maintenance tasks 66 Checking the recharger battery 67 Charging your recharger battery 69 Cleaning and care 72 Safety and technical checks 73 Battery and device disposal 75 Declaration of conformity 75 English 37751 03/2005 s t n e n o C t 4 A08366001 Rev X Printing instructions:

PatntTOC.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Specifications 76 Glossary Index 80 78 37751 03/2005 English A08366001 Rev X Printing instructions:

s t n e n o C t 5 PatntSym.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Label symbols Explanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply. CE 0123 Conformit Europenne

(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. documents w Caution: consult accompanying n Serial number Storage temperature Relative humidity l s o b m y s l e b a L 6 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntSym.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Atmospheric pressure kPa y IEC 60601-1/EN60601-1, Type BF equipment Non-ionizing electromagnetic radiation L Class II equipment System meets the applicable Canadian

[C22.2-601.1-M90 (R2001)] and US

(UL 60601-1:2003) electrical safety standard requirements. c For USA audiences only l s o b m y s l e b a L 37751 03/2005 English 7 A08366001 Rev X Printing instructions:

PatntSym.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 l s o b m y s l e b a L 8 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 1 Introduction A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Purpose of the device The Medtronic Model 37751 Charging System is designed to charge the Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulation System is intended to provide electrical stimulation to relieve severe, intractable pain. Restore Neurostimulation System indications, contraindications, risks and benefits, warnings, precautions, and individualization of treatment information is located in the Model 37742 Patient Programmer: Pain Therapy User Manual. Warnings DO NOT use the recharger on an unhealed wound. The recharger, antenna, and belt are not sterile, and contact with the wound can cause an infection. English 37751 03/2005 1 n o i t c u d o r t n I 10 A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03

Do not use the AC power supply near water or during a lightning storm. Electric shock, serious injury, or death may result. Precautions

Charge the neurostimulator when you see a low battery (

) screen on the patient programmer or recharger; this prevents the battery from overdischarging (see glossary). If the neurostimulator battery is allowed to overdischarge, charging is not possible; however, the clinician may be able to restore the battery function. Allowing the neurostimulator battery to overdischarge will permanently affect the neurostimulator in one of the following ways:

Battery function is restored; however, charging sessions may be more frequent because battery capacity has been reduced. Battery function is not restored, and the neurostimulator must be surgically 1 n o i t c u d o r t n I 37751 03/2005 English 11 A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 replaced. Battery function is not restored because:

The neurostimulator battery is permanently damaged.

The neurostimulator battery has been overdischarged and restored twice before. The third time the battery is overdischarged, the neurostimulator will reach end of service. Surgery is required to replace the neurostimulator.

Do not expose the recharger or antenna to extremely hot [eg, hot cars, saunas, or direct sunlight; +40C (104F)] or cold

[eg, walk-in freezers; 20C (4F)]

environments. The recharger and antenna are sensitive to temperature extremes and can become damaged.

Use only the Medtronic neurological charging system components to charge your recharger. Use of non-Medtronic English 37751 03/2005 1 n o i t c u d o r t n I 12 A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 charging equipment to charge the recharger can damage your charging system components.

When operating a 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. How to use this manual This manual is designed to help you understand your charging system. Ask your clinician to explain anything that is unclear.

Chapter 1, Introduction, describes the recharger keys and screens and how the system works.

Chapter 2, Using your charging system, describes the recharger and how to perform specific tasks. 1 n o i t c u d o r t n I 37751 03/2005 English 13 A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03

Chapter 3, Troubleshooting, describes recharger warning and information screens, how to solve possible charging system problems, and who to contact if your recharger is lost or broken.

Chapter 4, Maintenance, describes how to care for your recharger and contains system specifications and battery information.

A glossary is provided at the end of this manual. 1 n o i t c u d o r t n I 14 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Parts of your charging system Recharger AC power supply Antenna Belt Power cord Figure 1.1 Parts of your charging system. Recharger: The recharger is a hand-held device for charging the battery in your neurostimulator. It can also turn your neurostimulator ON or OFF. The display on the recharger provides information on your charging system. AC power supply and power cord: This device is used to charge the recharger using AC power. If you need to charge your 1 n o i t c u d o r t n I 37751 03/2005 English 15 A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 neurostimulator but your recharger battery is low, connect your recharger to the AC power supply to conduct a charging session. The power cord plugs into an electrical outlet and connects the AC power supply to the recharger. The power supply is a universal component. Note: Use only the power supply provided by Medtronic with your charging system. Antenna: The antenna connects to the recharger to establish communication with your neurostimulator. You can adjust a dial on the antenna to improve the charging efficiency between the recharger and the neurostimulator. Belt: The belt allows you to keep the antenna directly over your neurostimulator during a charging session. Pouch: The recharger fits into a pouch that can be attached to the belt so you can maintain your normal activities during a charging session. English 37751 03/2005 1 n o i t c u d o r t n I 16 A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 System carrying case: The carrying case is used to store the recharger, the charging system components, and your patient programmer. How your charging system works The charging system is used to charge your implanted neurostimulator battery. The battery in your recharger is similar to the rechargeable batteries commonly found in electronic devices. The battery typically lasts for approximately 5 years, depending upon your therapy needs and how often you use your recharger. Rechargeable batteries lose some of their power every day, even when not used. Charging sessions restore power to the recharger battery. Caution:

Charge the neurostimulator when you see a low battery (

) screen on the patient programmer or recharger; this prevents 1 n o i t c u d o r t n I 37751 03/2005 English 17 A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 the battery from overdischarging (see glossary). If the neurostimulator battery is allowed to overdischarge, charging is not possible; however, the clinician may be able to restore the battery function. Allowing the neurostimulator battery to overdischarge will permanently affect the neurostimulator in one of the following ways:

Battery function is restored; however, charging sessions may be more frequent because battery capacity has been reduced. Battery function is not restored, and the neurostimulator must be surgically replaced. Battery function is not restored because:

The neurostimulator battery is permanently damaged.

The neurostimulator battery has been overdischarged and restored twice before. The third time the battery is overdischarged, the English 37751 03/2005 1 n o i t c u d o r t n I 18 A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 neurostimulator will reach end of service. Surgery is required to replace the neurostimulator. Recharger keys and screens Recharger keys Five keys on the recharger allow you to control the recharger and turn your neurostimulator ON and OFF. NEUROSTIMULATOR ON NEUROSTIMULATOR OFF START CHARGE/TEST STOP CHARGE AUDIO CONTROL Figure 1.2 Recharger keys. 1 n o i t c u d o r t n I 37751 03/2005 English 19 A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03

NEUROSTIMULATOR ON neurostimulator ON.

NEUROSTIMULATOR OFF neurostimulator OFF.

START CHARGE/TEST the neurostimulator.

: Turns your

: Turns your

: Begins charging

STOP CHARGE

: Ends or interrupts charging the neurostimulator.

AUDIO CONTROL

: Turns your recharger ON. Note: When your recharger is ON, pressing the AUDIO CONTROL key turns audible status tones ON and OFF. The AUDIO CONTROL key is also used to display the recharger battery status. 1 n o i t c u d o r t n I 20 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:58 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Recharger screens Figure 1.3 shows the recharger screens. Status row Charge progress row Charge Neurostimulator charging session screen. efficiency row Recharger charging session screen. Figure 1.3 Recharger screens. The screens are separated into either two or three rows of icons. Status row Displays icon information for the recharger or neurostimulator. During a neurostimulator charging session, on the status row you will see:

Neurostimulator is ON (

Audio (sound) is ON (

Battery charge status of the recharger

, needs recharging to full,

) or OFF (

) or OFF (

)

)

(

respectively) 1 n o i t c u d o r t n I 37751 03/2005 English 21 A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03

The recharger is plugged into the AC power supply (

). If the recharger is not plugged into a power supply, this area of the screen will be blank.

) or OFF (

During a recharger charging session, the status row displays:

Audio (sound) is ON (

Charge progress row Indicates the progress of the charging session. During a neurostimulator charging session, you will see:

Current charge status of the

) neurostimulator battery. A flashing battery icon (

) indicates the neurostimulator is charging. When charging is complete, the NEUROSTIMULATOR CHARGING COMPLETE screen will display. 1 n o i t c u d o r t n I 22 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 During a recharger charging session, you will see:

Current charge status of the recharger battery. A flashing battery icon (

indicates the recharger is charging. When charging is complete, the RECHARGER CHARGING COMPLETE screen will display.

)

The connection icon (

), indicating that the power supply is connected to an operational electrical outlet. Charge efficiency row Displays a series of boxes indicating the efficiency of the charging signal between the neurostimulator and recharger. More solid black boxes (a maximum of eight) indicate a more efficient charging signal and a shorter charging session (

). The least efficient charge is indicated by empty boxes

(

). If you see six empty boxes, adjust the antenna to continue charging. 1 n o i t c u d o r t n I 37751 03/2005 English 23 A08366001 Rev X Printing instructions:

PatntCh01.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 1 n o i t c u d o r t n I 24 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 2 Using your charging system A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 This chapter includes information on:

the recharger battery and the charging procedure.

neurostimulator battery status icons.

charging your neurostimulator.

how to turn your neurostimulator ON or OFF during a charging session. the charging system accessories.

Battery and charging information Recharger and Neurostimulator

Charge the recharger or neurostimulator even if you are not using them for an extended period of time. 2 i m e t s y s g n g r a h c r u o y g n s U i 26 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03

You can charge the neurostimulator and recharger at the same time. Follow the instructions for both procedures

(Charging your neurostimulator battery on page 32 and Charging your recharger battery on page 69) at the same time.

Ensure you charge the batteries in your recharger and neurostimulator before they are low. Recharger

As your recharger ages, you will need to charge the battery more often.

The recharger battery might have run low since it was manufactured and shipped. You might need to charge it before you use it the first time. 2 i m e t s y s g n g r a h c r u o y g n s U i 37751 03/2005 English 27 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Neurostimulator

Your ability to locate your neurostimulator and the depth of the neurostimulator determine the efficiency of the charging session. With practice, you will find the best location on your skin for placing your recharger and antenna. If your neurostimulator is on while you are charging the battery, your charging session might last longer.

Depending on your therapy needs, charging your neurostimulator could take from one hour to more than 12 hours per week.

You can partially charge your neurostimulator if you do not have enough time for a complete charging session.

You can charge your neurostimulator at any time; you do not have to wait for a low battery message. 2 i m e t s y s g n g r a h c r u o y g n s U i 28 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Neurostimulator battery status Use your patient programmer to check your neurostimulator battery charge level every day. Refer to the manual supplied with the patient programmer. If either message in Table 2.1 is displayed, you must recharge the neurostimulator battery. Table 2.1 When to charge the neurostimulator. When you see this It means The neurostimulator battery charge level is low, and soon your therapy will not be available. Charge the neurostimulator battery. Press the gray AUDIO key on the recharger to clear the message. 2 i m e t s y s g n g r a h c r u o y g n s U i 37751 03/2005 English 29 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Table 2.1 When to charge the neurostimulator. When you see this

(continued) It means The neurostimulator battery charge level is low. Stimulation has stopped. Charge the neurostimulator battery now. Press the green Start charge/test key to clear the screen. Caution: Charge the neurostimulator when you

) screen on the patient see a low battery (

programmer or recharger; this prevents the battery from overdischarging (see glossary). If the neurostimulator battery is allowed to overdischarge, charging is not possible; however, the clinician may be able to restore the battery function. Allowing the neurostimulator battery to overdischarge will permanently affect the neurostimulator in one of the following ways:

Battery function is restored; however, charging sessions may be more frequent because battery capacity has been reduced.

Battery function is not restored, and the neurostimulator must be surgically replaced. Battery function is not restored because:

2 i m e t s y s g n g r a h c r u o y g n s U i 30 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Table 2.1 When to charge the neurostimulator. When you see this

(continued) It means The neurostimulator battery is permanently damaged. The neurostimulator battery has been overdischarged and restored twice before. The third time the battery is overdischarged, the neurostimulator will reach end of service. Surgery is required to replace the neurostimulator. 2 i m e t s y s g n g r a h c r u o y g n s U i 37751 03/2005 English 31 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Charging your neurostimulator battery Check with your clinician prior to using your recharger for the first time. When your neurostimulator needs to be charged, follow the steps below. Notes:

You might need to charge the recharger battery before you charge your neurostimulator battery. Refer to Recharger maintenance tasks on page 66.

Based on the configuration of your implanted neurostimulator, you might need to use more than one template

(Figure 2.1) to ensure the antenna remains positioned correctly over your neurostimulator. 1. Press your bare skin where your neurostimulator is located to determine the best place for the belt and antenna. 2 i m e t s y s g n g r a h c r u o y g n s U i 32 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Notes:

Do not place the antenna or belt over bulky clothing or bandages.

The antenna may be placed directly on your skin. However, if the antenna irritates your skin, you might want to wear a thin undergarment to protect your skin. 2. Put on your belt, with the template centered over your neurostimulator

(Figure 2.1) and secure the belt. Reposition your template, if necessary. Belt Implanted neurostimulator Template Figure 2.1 Place the belt over your neurostimulator. 3. Place the antenna in the template, and press it into the belt until it snaps into the openings on the template (Figure 2.2). 2 i m e t s y s g n g r a h c r u o y g n s U i 37751 03/2005 English 33 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Antenna Clips to lock antenna Figure 2.2 Attach the antenna to the belt. 4. Press the green START CHARGE/TEST key. The recharger wait screen will appear on the recharger display

(Figure 2.3). The RECHARGER WAIT screen indicates that the neurostimulator and recharger are trying to communicate. 2 i m e t s y s g n g r a h c r u o y g n s U i Figure 2.3 RECHARGER WAIT screen. When charging begins, the recharger displays a new screen indicating the 34 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 neurostimulator battery charge level and efficiency of the charging session

(Figure 2.4). Efficiency Charge neurostimulator Full charge Neurostimulator battery charge level Figure 2.4 Neurostimulator battery charge level and charging efficiency. The battery charge level updates throughout the charging session. Charging sessions can take a few minutes to more than 12 hours, depending on the charging efficiency, how often you charge, and your therapy needs. Notes:

If you need to interrupt your charging session, press the STOP CHARGE key.

You might hear periodic clicking noises during recharging, and you might see the screen refresh. 2 i m e t s y s g n g r a h c r u o y g n s U i 37751 03/2005 English 35 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 5. If the recharger screen shows a less efficient session, use the dial on the antenna to try to make the session more efficient. Turn the dial on the antenna one quarter turn in either direction

(Figure 2.5). Press the green START CHARGE/TEST display an updated efficiency status. key. The recharger will Note: The efficiency status screen will not be updated unless the START CHARGE/TEST key is pressed. 2 i m e t s y s g n g r a h c r u o y g n s U i Figure 2.5 Adjusting the antenna dial. Note: Repeat step 5 until the recharger screen indicates a more efficient charging session. Charging efficiency is affected by factors such as implant depth, and 36 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 efficiency will vary between patients. You and your clinician can work together to identify the best efficiency for you. 6. Periodically check the progress of the charging session by reviewing the icons on your recharger screen. If you see 6 empty boxes (

antenna to continue charging.

) adjust the 7. When your neurostimulator has a charge sufficient for use, you will see the following screen:

Figure 2.6 NEUROSTIMULATOR CHARGE SUFFICIENT FOR USE screen. 8. You can press the STOP CHARGE key to quit your charging session, if desired. You will hear three tones if the audio is ON. If you wait for the system to fully charge your neurostimulator, the 2 i m e t s y s g n g r a h c r u o y g n s U i 37751 03/2005 English 37 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 NEUROSTIMULATOR CHARGING COMPLETE screen will be displayed on the recharger display, and you will hear one tone, if the audio is ON (Figure 2.7). Figure 2.7 NEUROSTIMULATOR CHARGING COMPLETE screen. 9. Carefully expand the clips to unlock the antenna and remove it from the belt

(Figure 2.8). 2 i m e t s y s g n g r a h c r u o y g n s U i Figure 2.8 Removing the antenna. 10. Remove the belt and store the belt, antenna, and recharger in the charging system carrying case. 38 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Turning the neurostimulator ON and OFF while charging You can turn your neurostimulator ON or OFF during a charging session. To turn the neurostimulator ON while charging:

1. Press the NEUROSTIMULATOR ON 2. If audio is enabled, listen for the confirmation tone. key. 3. Verify that the NEUROSTIMULATOR ON icon

) is displayed on the recharger

(

screen. To turn the neurostimulator OFF while charging:

1. Press the NEUROSTIMULATOR OFF 2. key. If audio is enabled, listen for the confirmation tone. 3. Verify that the NEUROSTIMULATOR OFF icon (

screen.

) is displayed on the recharger 2 i m e t s y s g n g r a h c r u o y g n s U i 37751 03/2005 English 39 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Note: If you want to adjust stimulation using your patient programmer before your neurostimulator is completely charged, press the STOP CHARGE key on the recharger. You might need to remove the antenna so your patient programmer can communicate with your neurostimulator. Adjust stimulation with your patient programmer. Resume the charging session by pressing the START CHARGE/TEST key. 2 i m e t s y s g n g r a h c r u o y g n s U i 40 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Accessories Using the recharger pouch The recharger comes with a small pouch that you can wear on a belt during a charging session. Using this allows you to remain active during a charging session. Using the charging system carrying case The recharger comes with a carrying case to store the recharger and accessories. Using the case keeps the components clean and free from damage. Identification label Place an identification label on the back of your recharger in case the recharger is lost. 2 i m e t s y s g n g r a h c r u o y g n s U i 37751 03/2005 English 41 A08366001 Rev X Printing instructions:

PatntCh02.fm 8/23/04 7:59 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 2 i m e t s y s g n g r a h c r u o y g n s U i 42 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 3 Troubleshooting A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 This section will help you solve problems with your charging system. It also provides information on when to call your clinician or Medtronic. Note: If you cannot solve a problem, or if a problem is not described here, contact your clinician. Recharger screens The recharger displays warning (

information (

) screens to provide you with information about your system, alert you to a problem with your system, or to guide you during recharger use. Warning screens Warning screens (

with the recharger, the antenna, or the neurostimulator. If the audio is ON, three tones alert you to the screen. Table 3.1

) indicate a problem

) and English 37751 03/2005 3 g n i t o o h s e b u o r T l 44 A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 describes warning screens and provides instructions (see blue text) on how to resolve the problem and clear the screen. Table 3.1 Recharger warning screens s Warning screen Reposition antenna Cause and action You tried to turn your neurostimulator ON or OFF during a charging session, but the recharger did not communicate successfully with the neurostimulator. Reposition your antenna over your neurostimulator. Try again to turn your neurostimulator ON or OFF. The communication between your recharger and your neurostimulator was interrupted or could not be established. Reposition your antenna over your neurostimulator, and press the green START CHARGE/TEST key. 3 g n i t o o h s e b u o r T l 37751 03/2005 English 45 A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Table 3.1 Recharger warning screens (continued) s Warning screen Charge your neurostimulator battery Cause and action The neurostimulator battery charge level is low. Stimulation has stopped. Press the green START CHARGE/TEST key to clear the screen. Charge the neurostimulator battery now. Caution: Charge the neurostimulator when you

) screen on the patient see a low battery (

programmer or recharger; this prevents the battery from overdischarging (see glossary). If the neurostimulator battery is allowed to overdischarge, charging is not possible; however, the clinician may be able to restore the battery function. Allowing the neurostimulator battery to overdischarge will permanently affect the neurostimulator in one of the following ways:

Battery function is restored; however, charging sessions may be more frequent because battery capacity has been reduced.

Battery function is not restored, and the neurostimulator must be surgically replaced. Battery function is not restored because:

English 37751 03/2005 3 g n i t o o h s e b u o r T l 46 A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Table 3.1 Recharger warning screens (continued) s Warning screen Cause and action The neurostimulator battery is permanently damaged. The neurostimulator battery has been overdischarged and restored twice before. The third time the battery is overdischarged, the neurostimulator will reach end of service. Surgery is required to replace the neurostimulator. Charge your recharger battery Your recharger battery charge is insufficient to charge your neurostimulator. Charge your recharger with the AC power supply. Call doctor Your neurostimulator has reached end of service. Stimulation has stopped. Call your doctor immediately. 3 g n i t o o h s e b u o r T l 37751 03/2005 English 47 A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Table 3.1 Recharger warning screens (continued) s Warning screen Call clinician Cause and action Your system is not working correctly. Stimulation might have stopped. Call your clinician and provide the specific error code shown on the recharger display. 3 g n i t o o h s e b u o r T l 48 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03

) provide information Information screens Information screens (

and instructions on how to proceed. If the audio is ON, three tones alert you to the message. Press the AUDIO key on the recharger to clear the screen. Table 3.2 describes information screens. 3 g n i t o o h s e b u o r T l 37751 03/2005 English 49 A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Table 3.2 Recharger information screens

. Information screen Check antenna Description and action The antenna connection to the recharger is loose or your antenna is not connected. Check that the antenna and recharger are making full contact. Connect or tighten the connection and retry. The antenna or recharger might require service. Call Medtronic. Refer to the addresses and phone numbers on the inside back cover of this manual. 3 g n i t o o h s e b u o r T l 50 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Table 3.2 Recharger information screens

(continued) Information screen Move to a cooler environment;

ensure your system is not too hot Description and action Your antenna is too hot to work properly. Allow the antenna to cool and retry. Store the charging system components in a cool, dry place. Your skin temperature is too warm for a successful charging session. Move to a cool location, remove any excess clothing, allow your skin temperature to cool, and retry. The antenna may require service. Contact Medtronic. Refer to the addresses and phone numbers on the inside back cover of this manual. 3 g n i t o o h s e b u o r T l 37751 03/2005 English 51 A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Table 3.2 Recharger information screens

(continued) Information screen Description and action Note: This screen might appear during a recharging session, even if the antenna surface does not feel warm to you. Recharging will stop when this screen is displayed because the antenna is too warm for the system to work properly. Recharging will begin again once the surface temperature of the recharger antenna is within the operating range of the system. and keys were The AUDIO CONTROL STOP CHARGE pressed at the same time. Press the STOP CHARGE key to clear this message. Recharger system information English 37751 03/2005 3 g n i t o o h s e b u o r T l 52 A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Table 3.2 Recharger information screens

(continued) Information screen Charge your neurostimulator battery Description and action The neurostimulator battery charge level is low and stimulation will stop soon. Charge your neurostimulator battery using the recharger. Charge your recharger The recharger battery charge level is low. Charge your recharger battery using the AC power supply. Finish neurostimulator charging session The neurostimulator battery is only partially charged. You did not completely charge the neurostimulator battery. Finish charging your neurostimulator battery using the recharger, if desired. 3 g n i t o o h s e b u o r T l 37751 03/2005 English 53 A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Table 3.2 Recharger information screens

(continued) Information screen Finish recharger charging session Neurostimulator charging complete Description and action The recharger battery is only partially charged. You did not completely charge the recharger battery. Finish charging your recharger battery using the AC power supply, if desired. The neurostimulator battery contains sufficient charge for use. Press the AUDIO key to clear the message. Recharger charging complete The recharger battery is fully charged. Press the AUDIO key to clear the message. English 37751 03/2005 3 g n i t o o h s e b u o r T l 54 A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Table 3.2 Recharger information screens

(continued) Information screen Call clinician Call clinician Description and action There is a problem with a component of your system. Call your clinician and provide the specific error code shown on the recharger display. Your neurostimulator needs to be replaced, because stimulation will stop soon. Call your clinician and provide the message shown on the recharger display. 3 g n i t o o h s e b u o r T l 37751 03/2005 English 55 A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Possible problems and solutions The following table 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). Note: If a problem is not resolved after several attempts or if a problem is not described in the following table, contact your clinician. 3 g n i t o o h s e b u o r T l 56 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03

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PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 User assistance Your recharger 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 on the back of the recharger. This number identifies each recharger. If you contact Medtronic about your recharger, refer to the serial number. If your recharger stops working First try the steps in Table 3.3. Otherwise, contact Medtronic. If you lose your recharger Contact your clinician to order a new recharger. c To register the recharger for service covered by the warranty, complete and mail the warranty registration. 3 g n i t o o h s e b u o r T l 37751 03/2005 English 63 A08366001 Rev X Printing instructions:

PatntCh03.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 3 g n i t o o h s e b u o r T l 64 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh04.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 4 Maintenance A08366001 Rev X Printing instructions:

PatntCh04.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 This section describes how to care for and dispose of your recharger and accessories. Recharger maintenance tasks Maintaining the battery in your recharger ensures that you can charge your neurostimulator battery when needed. For information on charging and the batteries within the recharger, see Battery and charging information on page 26. 4 e c n a n e n a M t i 66 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh04.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Checking the recharger battery Press the gray AUDIO key on the recharger to turn ON your recharger and check the recharger battery charge level. The RECHARGER BATTERY CHARGE LEVEL screen displays the current battery charge level

(Figure 4.1). Battery charge level Charge recharger Full charge Figure 4.1 RECHARGER BATTERY CHARGE LEVEL screen and icons. Charge your recharger with the AC power supply when you see either of the screens in Table 4.1. 4 e c n a n e n a M t i 37751 03/2005 English 67 A08366001 Rev X Printing instructions:

PatntCh04.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Table 4.1 When to charge the recharger When you see this It means The recharger battery charge level is low and will lose power soon. Charge the recharger battery. Press the AUDIO key to clear the message, and charge the recharger battery. The recharger battery lost or is about to lose power. Charge the recharger battery immediately. 4 e c n a n e n a M t i 68 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh04.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Charging your recharger battery Follow the steps below to charge the recharger battery using the AC power supply. 1. Plug the AC power supply into your AC outlet (Figure 4.2). A green light indicates it has power. Warning: Do not use the AC power supply near water or during a lightning storm. Electric shock, serious injury, or death may result. Figure 4.2 Plug in the AC power supply. 2. Connect the recharger to the AC power supply (Figure 4.3). The recharger will automatically start to charge when connected to the AC power supply, and 4 e c n a n e n a M t i 37751 03/2005 English 69 A08366001 Rev X Printing instructions:

PatntCh04.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 the RECHARGER CHARGING SESSION screen will be displayed. (Figure 4.4). The charging session could take several hours, depending on the charge level of the batteries. Note: To interrupt a recharger charging session, disconnect the recharger from the AC power supply. Figure 4.3 Connect the recharger to the AC power supply. Figure 4.4 illustrates a RECHARGER CHARGING SESSION screen. 4 e c n a n e n a M t i 70 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh04.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Figure 4.4 RECHARGER CHARGING SESSION screen. 3. When the charging session is complete, the recharger will show a RECHARGER CHARGING COMPLETE screen (Figure 4.5.) Figure 4.5 RECHARGER CHARGING COMPLETE screen. 4. Unplug the AC power supply from the electrical outlet. 5. Disconnect the AC power supply from the 4 recharger. 6. Return the recharger, power cord, and AC power supply to the system carrying case. e c n a n e n a M t i 37751 03/2005 English 71 A08366001 Rev X Printing instructions:

PatntCh04.fm 8/23/04 8:00 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Cleaning and care Follow these guidelines to ensure that the recharger system and accessories function properly:

Keep the recharger, antenna, and AC power supply out of the reach of children.

Use the recharger, antenna, and AC power supply only as instructed by your clinician and this manual.

Handle the recharger, antenna, and AC power supply with care. Do not drop, strike or step on the components.

Do not dismantle or tamper with the recharger, antenna, or AC power supply.

Clean the outside of the recharger, antenna, and AC power supply with a damp cloth when necessary. Mild household cleaners will not damage the components.

The recharger, antenna, and AC power supply are not waterproof. Do not allow moisture to get inside the components. 4 e c n a n e n a M t i 72 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh04.fm 8/23/04 8:01 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03

The belt, with the antenna removed, can be washed with a mild laundry detergent in a washing machine and dried in a dryer on a low heat setting. Safety and technical checks Periodic safety and technical checks or periodic maintenance of the recharger are not required. The recharger contains no user-serviceable parts. If the recharger requires repair or is nonfunctional, send it to the appropriate address listed below. USA Medtronic, Inc. Neurological Division MSN600 PO Box 1250 Minneapolis, MN 55440-9087 4 e c n a n e n a M t i 37751 03/2005 English 73 A08366001 Rev X Printing instructions:

PatntCh04.fm 8/23/04 8:01 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Europe, Africa, Middle East, and Asia-Pacific countries Medtronic EOC Medical Equipment Service Europe Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. 31-455664880 Fax 31-455668028 4 e c n a n e n a M t i 74 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh04.fm 8/23/04 8:01 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Battery and device disposal Dispose of worn out devices according to local regulations. Do not incinerate. If you no longer need your recharger and would like to donate it, contact your clinician. Declaration of conformity Medtronic declares that this product is in conformity with the essential requirements of Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment and Directive 90/385/EEC on Active Implantable Medical Devices. For additional information, contact Medtronic. Refer to the list of Medtronic contacts at the end of this manual. 4 e c n a n e n a M t i 37751 03/2005 English 75 A08366001 Rev X Printing instructions:

PatntCh04.fm 8/23/04 8:01 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Specifications The following table lists the specifications for your recharger. Table 4.2 Recharger specifications Parameter Power source Operating temperature Storage temperature Specification 2 non-removable lithium-ion batteries (rechargeable)

+10 to +35C (+50 to +95F) 20 to +40C (4 to +104F) Operating/storage relative humidity 30% to 95%

Operating atmospheric pressure Storage atmospheric pressure Recharger size Recharger weight, including battery 700 hPa to 1060 hPa

(20.7 in. Hg to 31.3 in. Hg) 700 hPa to 1060 hPa

(20.7 in. Hg to 31.3 in. Hg) Approximately 13 x 8 x 3.18 cm

(5 x 3 x 1.25 inches) Approximately 227 g (8 oz.) 4 e c n a n e n a M t i 76 English 37751 03/2005 A08366001 Rev X Printing instructions:

PatntCh04.fm 8/23/04 8:01 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Table 4.2 Recharger specifications (continued) Parameter Battery life Power supply voltage Specification 5 years (life of device)a 100240V voltage (auto-ranging) Rated frequency 50/60 Hz Input current 0.35 A Outputs 0.85 A, 8.4 V dc (V charge) 0.5 A, 10 V dc (V base) Mode of operation Continuous a The longevity of your recharger battery is dependent upon how often you use your recharger. 4 e c n a n e n a M t i 37751 03/2005 English 77 A08366001 Rev X Printing instructions:

Patnt_GLS.fm 8/23/04 8:01 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Glossary Caution A statement describing actions that could result in damage to or improper functioning of a device. Clinician A health care professional such as a doctor or nurse. Contraindication A condition or circumstance when a person should not have a neurostimulation system. Indication The purpose of the neurostimulation system and the medical condition for which it may be implanted. Neurostimulator The power source of a neurostimulation system. It contains the battery and electronics that control the stimulation you feel. Overdischarge The neurostimulator battery continues to lose charge even after you see a low battery (

Eventually, the battery loses enough charge to permanently affect the neurostimulator. If this occurs, the battery is overdischarged.

) screen. English 37751 03/2005 y r a s s o G l 78 A08366001 Rev X Printing instructions:

Patnt_GLS.fm 8/23/04 8:01 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR00 Patient programmer A hand-held device that allows you to turn your neurostimulator ON and OFF. It is also used to adjust some of the stimulation settings. Precaution See Caution. Recharger The component of the Restore Neurostimulation System that is used to charge your neurostimulator battery. Stimulation The delivery of electrical pulses to the area where pain signals are blocked. Stimulation blocks some pain signals from reaching the brain. Template The cut-out area in the plastic part of the charging system belt. Warning A statement describing an action or situation that could harm the patient. Warning screen A screen displayed on the recharger that alerts you to a problem with the charging system. y r a s s o G l 37751 03/2005 English 79 A08366001 Rev X Printing instructions:

INSR_NueroPatntIX.fm 8/23/04 8:01 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Index AC power supply description 15 troubleshooting 58, 59, 61, 62 Accessories 41 Antenna description 16 troubleshooting 59, 60, 62 Antenna dial about 16 adjusting 3637 Audio control key 19, 20 Audio tones 38, 44 Battery (neurostimulator) See Neurostimulator battery Battery (recharger) See Recharger battery Belt 16 Care 72 Carrying case 17, 41 Charge efficiency row 23 Charge progress row 22 Charging efficiency 23, 3637 Charging neurostimulator and recharger at same time 27 Charging session neurostimulator battery 3438 recharger battery 7071 English 37751 03/2005 x e d n I 80 A08366001 Rev X Printing instructions:

INSR_NueroPatntIX.fm 8/23/04 8:01 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Charging system cleaning and care 72 how it works 17 parts 1517 Charging the neurostimulator battery procedure 3238 turning neurostimulator ON and OFF while charging 3940 Charging the recharger battery 6971 Checking recharger battery 6768 Cleaning 72 Dial (antenna) about 16 adjusting 3637 Disposing of devices 75 Identification label 41 Information screens 4955 Interrupting neurostimulator battery charging session 35 recharger battery charging session 70 Keys, recharger 19 Maintenance 6671 Neurostimulation system 10 Neurostimulator charging information 2627, 28 turning ON and OFF while charging 3940 See also Neurostimulator battery x e d n I 81 37751 03/2005 English A08366001 Rev X Printing instructions:

INSR_NueroPatntIX.fm 8/23/04 8:01 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Neurostimulator battery battery level messages 2930, 46 charging 3238 checking status 29 interrupting charging session 35 See also Neurostimulator Neurostimulator OFF key 19, 20 Neurostimulator ON key 19, 20 Patient programmer 29 Pouch 16, 41 Power cord 15 Power supply See AC power supply Precautions 1113 Recharger charging information 2627 description 15 troubleshooting 57, 59, 60, 62 See also Recharger battery Recharger battery about 17 charging 6971 checking charge level 6768 interrupting charging session 70 maintaining 6671 See also Recharger Recharger keys 19 x e d n I 82 English 37751 03/2005 A08366001 Rev X Printing instructions:

INSR_NueroPatntIX.fm 8/23/04 8:01 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 Recharger screens about 2123 information screens 4955 Neurostimulator charging session screen 21 Recharger charging session screen 21 warning screens 4448 Recharger system See Charging system Repair address 73 Screens See Recharger screens Serial number 63 Specifications 76 Start charge/Test key 19, 20 Status row 21 Stop charge key 19, 20, 35 Template 33 Test (Start charge/Test) key 19, 20 Tones, audio 38, 44 Troubleshooting 4462 Turning neurostimulator ON and OFF while charging 3940 Warning screens 4448 Warnings 1011 Warranty registration 63 x e d n I 83 37751 03/2005 English A08366001 Rev X Printing instructions:

INSR_NueroPatntIX.fm 8/23/04 8:01 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntR03 x e d n I 84 English 37751 03/2005 A08366001 Rev X Printing instructions:

Patntbcv.fm 8/23/04 8:01 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 sterreich 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 Birkerd Kongevej 150B, DK-3460 Birkerd 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 Gnral Leclerc, 92514 Boulogne-Billancourt Cedex Tel. 01-5538-1700 Fax 01-5538-1800 Germany: Medtronic GmbH Emanuel-Leutze-Strae 20, 40547 Dsseldorf, 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 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 Hvik Tel. 67 58 06 80 Fax 67 10 12 12 Portugal: Medtronic Portugal, Lda. Rua Toms da Fonseca, Torre E 8, andar A,B, 1600 - 209 Lisboa Tel.21-724-5100 Fax 21-724-5199 Spain: Medtronic Ibrica, S.A. Centro Empresarial Miniparc III, Edificio K, Calle Calndula, 93, El Soto de la Moraleja, 28109 Alcobendas - Madrid Tel. 91-625-0400 Fax 91-650-7410 Sweden: Medtronic AB Dackevgen 33, Box 265 S-177 25 Jrflla 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 A08366001 Rev X Printing instructions:

Patntbcv.fm 8/23/04 8:01 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 Srl 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.

*A08366001*

Medtronic, Inc. 2005 All Rights Reserved A08366001 A08366001 Rev X Printing instructions:

Medtronic INSR Programmer - Disassembly View 1 Medtronic INSR Programmer - Disassembly View 2 Medtronic INSR Programmer - Disassembly View 3 Medtronic INSR Programmer - Recharge Board Top Medtronic INSR Programmer - Recharge Board Bottom Medtronic INSR Programmer - Digital Board Top Medtronic INSR Programmer - Digital Board Bottom Medtronic INSR Programmer - Digital Board - LCD Medtronic INSR Programmer - Antenna Disassembly - View 1 Medtronic INSR Programmer - Antenna Disassembly - View 2 Medtronic INSR Programmer - Antenna Disassembly - View 3 Medtronic INSR Programmer - Antenna Disassembly - View 4

Medtronic Recharging System Medtronic INSR Programmer - Top Medtronic INSR Programmer - Bottom Medtronic INSR Programmer - Front View Medtronic INSR Programmer - Left and Back View Medtronic INSR Programmer - Right and Back View Medtronic INSR Programmer - Antenna Top View Medtronic INSR Programmer - Antenna Bottom View

Because of the small size of the device, the compliance statement will be placed in the user manual. Label placement (prototype label shown in photo. See label on previous page for final product label).

Block Diagram Description Push Button Matrix LCD Lighting LCD Module Digtal Board INSR Board Reset Button

+

L i 2 s e i r e t t a B Software Loading Port IRDA Audio Transducer System Memory / I/O Crystal 32.768 kHz RTC Crystal 9.8304MHz TEL_EN UPLINK_EN Digtal Board INSR Board uP A/D Receive D A

/

D A

/

D A

/

D A

/

D A

/

Transmit 3V Reference BATTERY BAT_CHRG_EN DOCK_DETECT L R T C _ V H T A B _ V EXT_ANT PTEMP_TEST PTEMP_SENSOR G R H C E R _ I SHDN_HV 2 1 _ V Q13 I Measure 3.3V Analog Supply 12V Supply AVCC Bridge Circuit 3V Reference 3V Reference V_3.3 Analog 3.3V_CONTROL BURST_MODE 3.3V Digital Supply V_3.3 Desktop Charger Connector CHARGE VBASE (10V Power) READY GND Recharge Frequency:

9kHz Recharge Antenna, Model 37791 Recharge Coil Telemetry Antenna Temp Sensor Transmit Frequency:

175kHz RESTORE INSR

American Telecommunications Certification Body Inc. 6731 Whittier Ave, McLean, VA 22101 April 21, 2005 RE:

FCC ID:

Medtronic Inc. LF537751 After a review of the submitted information, I have a few comments on the above referenced Application. 2) 1) According to ANSI C63.4 (13.1.4.1), Portable devices are required to be positioned in each of 3 axis and measured to obtain worse case. This does not appear to have been done. Please review?

It appears the fundamental was measured in average mode. Please note that there is also a limit on the peak emissions that is 20 dB above the average limit (15.35). It is also unsure of what type of modulation was present but information in the operational description suggests this will be pulsed emissions. Therefore the FCC expects the device to have been measured in peak mode and corrected mathematically for average. Please provide further information as necessary. For instance, what was the peak to average ratio. What type of modulation was present. Note that the operational description (section 1.4.1) mentions pulse duration and pulse position as possible encoding schemes. This would suggest that peak emissions corrected for worse case average factors should have been applied. 3) The device appears to have pulse width and amplitude adjustments from the programmer. How do these settings affect the RF output (waveform)? Are these sent only as data commands to the stimulation device or is the RF envelope affected? For instance is a programming of the amplitude of the stimulation device accomplished by sending data to the stimulation device, or does the programmer TX waveform actually change amplitude as well. Note it appears from information in the operational description that the duty cycle is affected directly based upon the duty cycle entered in the programmer and that the amplitude may also vary according to programming. The device should have been tested at maximum RF output levels as well as maximum duty cycle. Please explain. It appears that the extrapolation of this device would be 46 dB per decade and not 48 dB per decade. Please review and correct as necessary. 5) Please explain how the loop antenna (measurement antenna) was positioned and maximized during test. Loop antennas should be checked positioned in Vertical and Horizontal polarities according to ANSI C63.4 at a 1 meter height. Additionally, Vertical polarity should have been rotated about the Vertical axis to obtain worse case (ANSI C63.4 8.2.1). Antenna positioning can dramatically affect the results. No mention of antenna positioning appears in the report. Please explain. 4)

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Page 2 April 21, 2005 6) The recharge circuit (operational description section 5.10.8.2) suggests the recharge circuit can operated from 8.455 to 9.345 kHz. Operation above 9 kHz would be subject to Part 15 for Certification and would require testing and submittal as part of this application. This information does not appear to have been provided. Additionally, note that information in the operational description suggests this field will be much higher than the telemetry field. If operation will be limited only to below 9 KHz, how is compliance to 15.15 assured given the information in the operational description?

Timothy R. Johnson Examining Engineer mailto: tjohnson@AmericanTCB.com The items indicated above must be submitted before processing can continue on the above referenced application. Failure to provide the requested information may result in application termination. Correspondence should be considered part of the permanent submission and may be viewed from the Internet after a Grant of Equipment Authorization is issued. Please do not respond to this correspondence using the email reply button. In order for your response to be processed expeditiously, you must submit your documents through the AmericanTCB.com website. Also, please note that partial responses increase processing time and should not be submitted. Any questions about the content of this correspondence should be directed to the sender.

American Telecommunications Certification Body Inc. 6731 Whittier Ave, McLean, VA 22101 April 21, 2005 RE:

FCC ID:

Medtronic Inc. LF537751 After a review of the submitted information, I have a few comments on the above referenced Application. 1) Please kindly consider correcting the 175 kHz report to properly discuss peak and average emissions. Information regarding this does not appear to be provided in the Revision B Report. 2) Regarding the 9 kHz report, it appears that the extrapolation of this device would be 52.4 dB per decade and not 48 dB per decade as given on page 11. Note that page 22 mentions 50 dB. Please review and correct as necessary. 3) The results on page 11 of the 9 kHz report do not appear to match the data on page 22. Please explain and/or correct as necessary. Timothy R. Johnson Examining Engineer mailto: tjohnson@AmericanTCB.com The items indicated above must be submitted before processing can continue on the above referenced application. Failure to provide the requested information may result in application termination. Correspondence should be considered part of the permanent submission and may be viewed from the Internet after a Grant of Equipment Authorization is issued. Please do not respond to this correspondence using the email reply button. In order for your response to be processed expeditiously, you must submit your documents through the AmericanTCB.com website. Also, please note that partial responses increase processing time and should not be submitted. Any questions about the content of this correspondence should be directed to the sender.

American Telecommunications Certification Body Inc. 6731 Whittier Ave, McLean, VA 22101 April 29, 2005 RE:

FCC ID:

Medtronic Inc. LF537751 After a review of the submitted information, I have a few comments on the above referenced Application. 1) Earlier information regarding 175 kHz mentioned that the peak to average difference was 8 dB, while the latest corrected report mentions 3 dB. Please confirm the correct ratio. Timothy R. Johnson Examining Engineer mailto: tjohnson@AmericanTCB.com The items indicated above must be submitted before processing can continue on the above referenced application. Failure to provide the requested information may result in application termination. Correspondence should be considered part of the permanent submission and may be viewed from the Internet after a Grant of Equipment Authorization is issued. Please do not respond to this correspondence using the email reply button. In order for your response to be processed expeditiously, you must submit your documents through the AmericanTCB.com website. Also, please note that partial responses increase processing time and should not be submitted. Any questions about the content of this correspondence should be directed to the sender.

19 April 2005 Attn: Director of Certification 19 April 2005 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Attn: Reviewing Engineer

, INSR, FCC ID: LF537751

TV America Inc. Product Service 1775 Old Highway 8 NW Suite 104 New Brighton, MN 55112 Phone: (651) 631-2487 Fax: (651) 638-0285 E-mail: info@tuvam.com www.TUVamerica.com TV AMERICA INC - PRODUCT SERVICE 19333 WILD MOUNTAIN ROAD TAYLORS FALLS, MINNESOTA 55084-1786 ENGINEERING STATEMENT Implantable Neurostimulator (INS) Recharger (INSR) For Certification of Medtronic Inc Model No: 37751, 37752 FCC ID: LF537751 FRN: 0010-0391-05 The Implantable NeuroStimulator Recharger (INSR) platform design is identified via model 37751. This platform is designed to be the base hardware and software application for the market release product. The model 37752 represents the Patient Recharge System that contains the model 37751, the external power supply, power cord, the recharge belt and carrying case. The FCC ID number was chosen to represent the main communication device, which is the model 37751 (accessories used during testing: external power supply, power cord). The model 37751 will be used to recharge the Implantable Neurostimulator (INS) model 37711, as well as be able to control start and stop stimulation. The external power supply will be used to recharge the INSR batteries, as well as to power the INSR directly. I am an Electromagnetic Compatibility Engineer for TV AMERICA INC - PRODUCT SERVICE, Taylors Falls, Minnesota. My education and experience are a matter of record with the Federal Communications Commission. TV AMERICA INC - PRODUCT SERVICE has been authorized by Kevin Kelly, Stim Product Development Director, of Medtronic Inc to make Certification measurements and act as the authorized representative in the preparation of applications for registration of the above mentioned equipment. TV AMERICA INC - PRODUCT SERVICE is on file with the FCC under Paragraph 2.948 of the FCC Rules. Test data required by the TCB for Certification is included in this report. It is submitted that the above equipment meets the FCC Part 15 Subpart C requirements and Certification is hereby requested. Joel T. Schneider Senior Engineer Minnesota Wild River Lab TV America - Product Service Tel: 651 604 4582 Fax: 651 638 0298 jschneider@tuvam.com Dated: 20 April 2005 Management Service Product Service Industry Service Automotive BABT TV America Inc. is a subsidiary of Group TV Sddeutschland.

Phone: (651) 631-2487 Fax: (651) 638-0285 E-mail: info@tuvam.com www.TUVamerica.com TV America Inc. 1775 Old Highway 8 NW Suite 104 New Brighton, MN 55112 22 April 2005 RE:

FCC ID: LF537751 In response to ATCB comments on the above referenced application. 1. Page C2 of C2 describes the EUT was examined in 3 orthogonal axes. Test setup photographs Medtronic Inc indicate the worst case configuration. 2. This is an omission in the test report. Peak measurements were made, and were 8 dB higher than the average measurements. Reports will be corrected and resent. Modulation type was Continuous Wave Amplitude Burst Modulation. 3. The patient programmer is the only device that can adjust the pulse width and amplitude of the implantable neurostimulator (INS). The INSR is only able to turn the INS on and off and recharge. Even though the programmer can adjust these parameters, the RF output of the patient programmer isn't affected because it's just commands that are being transmitted from the programmer to the INS. The pulse width and amplitude adjustments are for the implant's therapy stimulation output. It has no bearing on RF output levels. 4. The report has been corrected to 46 dB/decade. 5. ANSI C63.4 procedures are followed - page C2 of C2 describes procedure used. 6. The recharge circuit operates at the 9 kHz frequency, not at 8 kHz as was originally indicated, and the frequencies can not be transmitted simultaneously. Measurements had been made on the 9 kHz recharge circuit but we had been told that the device operated at less than 9 kHz so had not included the report with the original documents submitted. In addition to the 9 kHz Test Report, the 175 kHz Test Report, Test Setup Photos, Block Diagram, Form 731, RF Exposure Letter, and Technical Description exhibits have been revised accordingly and uploaded at the same time as this correspondence. Please let us know if you require any further information. Thank you. Jolene Murphy Senior Technical Writer jmurphy@tuvam.com Management Service Product Service Industry Service Automotive BABT TV America Inc. is a subsidiary of TV SD Group.

Phone: (651) 631-2487 Fax: (651) 638-0285 E-mail: info@tuvam.com www.TUVamerica.com TV America Inc. 1775 Old Highway 8 NW Suite 104 New Brighton, MN 55112 26 April 2005 RE:

FCC ID: LF537751 In response to 25 April 2005 ATCB comments on the above referenced application. Both test reports have been revised and uploaded at the same time as this correspondence. Please let us know if you require any further information. Thank you. Medtronic Inc Jolene Murphy Senior Technical Writer jmurphy@tuvam.com Management Service Product Service Industry Service Automotive BABT TV America Inc. is a subsidiary of TV SD Group.

Phone: (651) 631-2487 Fax: (651) 638-0285 E-mail: info@tuvam.com www.TUVamerica.com TV America Inc. 1775 Old Highway 8 NW Suite 104 New Brighton, MN 55112 29 April 2005 RE:

FCC ID: LF537751 In response to 29 April 2005 ATCB comments on the above referenced application. The peak to average difference of 3 dB is correct for FCC ID: LF37751. Please let us know if you require any further information. Thank you. Medtronic Inc Joel T Schneider Senior Engineer Management Service Product Service Industry Service Automotive BABT TV America Inc. is a subsidiary of TV SD Group.