Medtronic 37751 Users Manual

Page 1

Neurological

Date

24 August 2004

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 wit hout proper authorization.

Medtronic Confidential

Title

Model 37751 INSR patient manual

Writer

Theresa King-Hunter

Part No. Part No. Rev Comments

A08366001 A Global market release

DO NOT PRIN T THIS FORM W HEN PRINTING THE LITERATURE PIEC E. D

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

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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

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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): 86

Note to print supplier: Supplier may add up to three blank pages at the end of the

document before the back cover sheet as needed. If more are required, contact the purchasing agent.

8. Vendor-supplied information

may appear

at an appropriate location on the literature

piece (eg, part number, bar code, etc.).

9. Graphics Content and Layout to be as shown and per Medtronic electronic file that is supplied (stored) by Medtronic Neuro.

Page 1

Form MEDN-0043 version 6.0

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PatntFC.fm 8/23/04 7:57 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN

RECHARGER 37751

Charging System user manual

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c Rx Only

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2005

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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.

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Contents

Label symbols 6

1Introduction9

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

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2 Using your charging system 25

Battery and charging information 26

Neurostimulator battery status 29 Charging your neurostimulator battery 32

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Recharger and Neurostimulator 26 Recharger 27 Neurostimulator 28

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Turning the neurostimulator ON and OFF while charging 39

Accessories 41

Using the recharger pouch 41 Using the charging system carrying

case 41

Identification label 41

3 Troubleshooting 43

Recharger screens 44

Warning screens 44 Information screens 49

Possible problems and solutions 56 User assistance 63

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4 Maintenance 65

Recharger maintenance tasks 66

Cleaning and care 72 Safety and technical checks 73 Battery and device disposal 75

Contents

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Declaration of conformity 75

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Checking the recharger battery 67 Charging your recharger battery 69

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Specifications 76

Glossary 78

Index 80

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Label symbols

Explanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply.

0123

Caution: consult accompanying

documents

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Conformité Européenne (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.

Label symbols

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Serial number

Storage temperature

Relative humidity

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kPa

Atmospheric pressure

IEC 60601-1/EN60601-1, Type BF equipment

Non-ionizing electromagnetic radiation

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

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1 Introduction

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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.

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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.

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• 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:

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– Battery function is restored; however,

– Battery function is not restored, and the

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charging sessions may be more frequent because battery capacity has been reduced.

neurostimulator must be surgically

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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; +40°C (104°F)] or cold [eg, walk-in freezers; –20°C (–4°F)] environments. The recharger and antenna are sensitive to temperature extremes and can become damaged.

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• Use only the Medtronic neurological

charging system components to charge your recharger. Use of non-Medtronic

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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 batterypowered 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.

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• 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.

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• 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.

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Parts of your charging system

Recharger

AC power supply

Power cord

Figure 1.1 Parts of your charging system.

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Belt

Antenna

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

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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.

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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.

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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.

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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

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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:

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• The neurostimulator battery is permanently damaged.

• The neurostimulator battery has been overdischarged and restored twice before. The third time the battery is overdischarged, the

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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

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START CHARGE/TEST

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STOP CHARGE

AUDIO CONTROL

Figure 1.2 Recharger keys.

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•NEUROSTIMULATOR ON : Tur n s your neurostimulator ON.

•NEUROSTIMULATOR OFF : Turns your neurostimulator OFF.

•START CHARGE/TEST : Begins charging the neurostimulator.

•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.

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Recharger screens

Figure 1.3 shows the recharger screens.

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Status row

Charge

progress row

Neurostimulator charging session screen.

Charge

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 ( ) or OFF ( )

• Audio (sound) is ON ( ) or OFF ( )

• Battery charge status of the recharger

( , needs recharging to full, respectively)

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• 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.

During a recharger charging session, the status row displays:

• Audio (sound) is ON ( ) or OFF ( )

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.

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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.

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2 Using your

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charging system

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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.

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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.

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• 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.

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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.

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• 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.

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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

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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.

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Table 2 .1 When to charge the neurostimulator.

When you see this It means

Caution: 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 replaced. Battery function is not restored because:

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(continued)

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.

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Table 2 .1 When to charge the neurostimulator.

When you see this 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.

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(continued)

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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.

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1. Press your bare skin where your

neurostimulator is located to determine the best place for the belt and antenna.

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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

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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).

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Implanted

neurostimulator

Te m p l a t e

Figure 2.1 Place the belt over your

neurostimulator.

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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.

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Antenna

Clips to lock antenna

When charging begins, the recharger displays a new screen indicating the

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Figure 2.3 RECHARGER WAIT screen.

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neurostimulator battery charge level and efficiency of the charging session (Figure 2.4).

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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 S

TOP CHARGE key.

• You might hear periodic clicking noises

during recharging, and you might see the screen refresh.

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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 key. The recharger will

display an updated efficiency status.

Note: The efficiency status screen will not be updated unless the START CHARGE/TEST key is pressed.

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Note: Repeat step 5 until the recharger

screen indicates a more efficient charging session. Charging efficiency is affected by

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factors such as implant depth, and

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Figure 2.5 Adjusting the antenna dial.

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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 ( ) adjust the antenna to continue charging.

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

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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

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Figure 2.6 NEUROSTIMULATOR CHARGE

SUFFICIENT FOR USE screen.

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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

9. Carefully expand the clips to unlock the

antenna and remove it from the belt (Figure 2.8).

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COMPLETE screen.

10. Remove the belt and store the belt, antenna, and recharger in the charging

Using your charging system 2

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system carrying case.

English 37751 03/2005

Figure 2.8 Removing the antenna.

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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 key.

2. If audio is enabled, listen for the

confirmation tone.

3. Verify that the NEUROSTIMULATOR ON icon ( ) is displayed on the recharger screen.

To turn the neurostimulator OFF while charging:

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1. Press the NEUROSTIMULATOR OFF

key.

2. If audio is enabled, listen for the confirmation tone.

3. Verify that the N icon ( ) is displayed on the recharger screen.

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EUROSTIMULATOR OFF

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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.

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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.

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Identification label

Place an identification label on the back of your recharger in case the recharger is lost.

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3 Troubleshooting

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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 () and 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.

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Warning screens

Warning screens ( ) indicate a problem with the recharger, the antenna, or the neurostimulator. If the audio is ON, three tones alert you to the screen. Table 3.1

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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

Warning screen Cause and action

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Reposition antenna

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 S

CHARGE/TEST key.

TART

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Table 3 .1 Recharger warning screens (continued)

Warning screen Cause and action

Charge your neurostimulator battery

Caution: 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 replaced.

Troubleshooting 3

Battery function is not restored because:

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The neurostimulator battery charge level is low. Stimulation has stopped.

Press the green S

CHARGE/TEST key to clear the

TART

screen.

Charge the neurostimulator battery now.

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Table 3 .1 Recharger warning screens (continued)

Warning screen Cause and action

The neurostimulator battery is permanently damaged.

Charge your recharger battery

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Your recharger battery charge is insufficient to charge your neurostimulator.

Charge your recharger with the AC power supply.

Call doctor Your neurostimulator has

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reached end of service. Stimulation has stopped.

Call your doctor immediately.

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Table 3 .1 Recharger warning screens (continued)

Warning screen Cause and action Call clinician Your system is not working

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correctly. Stimulation might have stopped.

Call your clinician and provide the specific error code shown on the recharger display.

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Information screens

Information screens ( ) provide information 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.

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Table 3 .2 Recharger information screens

Information screen

Check antenna The antenna connection to the

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Description and action

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.

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Table 3 .2 Recharger information screens

Information screen

Move to a cooler environment; ensure your system is not too hot

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(continued)

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.

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Table 3 .2 Recharger information screens

Information screen

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(continued)

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.

Recharger system information

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The A

UDIO CONTROL and

TOP CHARGE keys were

pressed at the same time.

Press the S

TOP CHARGE key to

clear this message.

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Table 3 .2 Recharger information screens

Information screen

Charge your neurostimulator battery

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(continued)

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

Finish neurostimulator charging session

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The recharger battery charge level is low.

Charge your recharger battery using the AC power supply.

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.

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Table 3 .2 Recharger information screens

Information screen

Finish recharger charging session

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(continued)

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.

Neurostimulator charging complete

Recharger charging complete

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The neurostimulator battery contains sufficient charge for use.

Press the A

UDIO key to clear

the message.

The recharger battery is fully charged.

Press the A

UDIO key to clear

the message.

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Table 3 .2 Recharger information screens

Information screen

Call clinician There is a problem with a

Call clinician Your neurostimulator needs to

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(continued)

Description and action

component of your system.

Call your clinician and provide the specific error code shown on the recharger display.

be replaced, because stimulation will stop soon.

Call your clinician and provide the message shown on the recharger display.

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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.

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Table 3 .3 Troubleshooting

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Problems Causes and actions

The recharger battery is low.

Attach the AC power supply to the recharger.

The recharger is broken.

Contact your doctor.

Electronic devices might be interfering with the

recharger communication signal.

Move away from all electronic devices (eg,

TVs, computer monitors, or microwaves), and

retry.

Your recharger screen

does not turn on when

you try to charge your

neurostimulator

You cannot turn ON your

neurostimulator with the

recharger

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Table 3 .3 Troubleshooting (continued)

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The power cord might not be plugged into the AC

power supply or electrical outlet.

Connect the power cord to the electrical

Your AC power supply will

not turn ON (the light on

the supply does not turn

Problems Causes and actions

green when you plug it in)

outlet.

The connection to the power cord might be loose.

Reseat the electrical cord on the AC power

supply.

The power cord connected to the AC power

supply might be incompatible with the electrical

outlet.

Obtain an adapter for the type of electrical

outlet you are using.

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electrical outlet, interrupt the flow of

electricity to the outlet. Unplug the power

supply.

1. If the AC power supply is plugged into an

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2. Dry the component with a towel.

Table 3 .3 Troubleshooting (continued)

Problems Causes and actions

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You spill fluid on your

recharger, antenna, or AC

power supply

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electrical outlet, interrupt the flow of

electricity to the outlet. Unplug the power

supply.

1. If the AC power supply is plugged into an

2. Remove the recharger or antenna from the

water.

with a towel dampened with clean water.

3. If the recharger or antenna is dirty, wipe it

4. Shake the recharger or antenna.

5. If you see or hear water inside, wipe it dry

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with a clean towel. Repeat steps 4 and 5.

use it.

6. When the recharger or antenna is dry, try to

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Table 3 .3 Troubleshooting (continued)

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Problems Causes and actions

Your recharger or antenna

falls into water

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breaker fuse box, if the AC power cord is

plugged into an electrical outlet. Unplug

the power supply.

1. Turn off the power, preferably at the

2. Remove the AC power supply from water.

3. If it is dirty, wipe it with a towel dampened

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GROUNDED

with clean water.

for a few hours.

hear water inside, repeat steps 4 and 5 until

the power supply is thoroughly dry.

electrical outlet. A green light on the top of

the power supply will come on if it is

working properly.

4. Leave the AC power supply on a dry towel

5. Shake the AC power supply. If you see or

6. Plug the power cord into a

Table 3 .3 Troubleshooting (continued)

Problems Causes and actions

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Your AC power supply

falls into water

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Table 3 .3 Troubleshooting (continued)

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Problems Causes and actions

The recharger, antenna, and AC power supply are

Your recharger, antenna,

designed to withstand falls of short distances.

or AC power supply falls

Try the recharger, antenna, or AC power

off a cabinet or table

supply; they should work.

Your recharger is beeping You cannot resolve the problem or you see a

screen other than those described in this section.

Contact your clinician to resolve the problem.

The recharger wait screen did not appear when

you pressed the START CHARGE/TEST key.

Connect your recharger to the AC power

supply and follow the directions for charging

your recharger on page 69.

Note: If the Recharger charging screen does

not appear after you connect the recharger to

the AC power supply, contact your clinician.

Your recharger screen is

blank

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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.

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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.

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4 Maintenance

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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.

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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

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Figure 4.1 RECHARGER BATTERY CHARGE LEVEL

Charge your recharger with the AC power supply when you see either of the screens in Ta bl e 4 .1 .

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Charge recharger

screen and icons.

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Full

charge

Maintenance 4

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Table 4 .1 When to charge the recharger

When you see this It means

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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.

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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.

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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

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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.

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Figure 4.3 Connect the recharger to the AC

Figure 4.4 illustrates a RECHARGER CHARGING

SESSION screen.

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power supply.

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Figure 4.4 R

ECHARGER 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 recharger.

6. Return the recharger, power cord, and AC power supply to the system carrying case.

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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.

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• 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

Maintenance 4

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moisture to get inside the components.

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• 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.

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USA

Medtronic, Inc. Neurological Division MSN600 PO Box 1250 Minneapolis, MN 55440-9087

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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

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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.

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Specifications

The following table lists the specifications for your recharger.

Table 4 .2 Recharger specifications

Parameter Specification

Power source 2 non-removable lithium-ion

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batteries (rechargeable)

Operating temperature

Storage temperature

Operating/storage relative humidity

Operating atmospheric pressure

Storage atmospheric pressure

Recharger size Approximately 13 x 8 x 3.18 cm

Recharger weight, including battery

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+10 to +35°C (+50 to +95°F)

–20 to +40°C (–4 to +104°F)

30% to 95%

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

(5 x 3 x 1.25 inches)

Approximately 227 g (8 oz.)

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Table 4 .2 Recharger specifications (continued)

Parameter Specification

Battery life

5 years (life of device)

Medtronic Confidential

NeuroPatntR03

Power supply

100–240V voltage (auto-ranging)

voltage

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

The longevity of your recharger battery is dependent

upon how often you use your recharger.

Maintenance 4

A08366001 Rev X

37751 03/2005 English

Printing instructions:

Page 79

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

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.

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NeuroPatntR00

Overdischarge – The neurostimulator

battery continues to lose charge even after you see a low battery ( ) screen. Eventually, the battery loses enough charge to permanently affect the neurostimulator. If

Glossary

this occurs, the battery is overdischarged.

A08366001 Rev X

English 37751 03/2005

Printing instructions:

Page 80

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

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.

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NeuroPatntR00

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.

A08366001 Rev X

37751 03/2005 English

Printing instructions:

Glossary

Page 81

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

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 36–37 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, 36–37 Charging neurostimulator and recharger at same time 27 Charging session

neurostimulator battery 34–38

Index

recharger battery 70–71

Medtronic Confidential

NeuroPatntR03

A08366001 Rev X

English 37751 03/2005

Printing instructions:

Page 82

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

Charging system

cleaning and care 72 how it works 17 parts 15–17

Charging the neurostimulator battery

procedure 32–38 turning neurostimulator ON and OFF while

charging 39–40 Charging the recharger battery 69–71 Checking recharger battery 67–68 Cleaning 72 Dial (antenna)

about 16

adjusting 36–37 Disposing of devices 75 Identification label 41 Information screens 49–55 Interrupting

neurostimulator battery charging session 35

recharger battery charging session 70 Keys, recharger 19 Maintenance 66–71 Neurostimulation system 10 Neurostimulator

charging information 26–27, 28

turning ON and OFF while charging 39–40