Version: 01-18-2012 4.625 x 6.0 inches (117 mm x 152 mm ......XXX °F XX °C-XX °F-XX °C Temperature limitation Serial number MR Magnetic Resonance (MR) Unsafe Non-ionizing electromagnetic

RECHARGER 37751Charging System user manual

! USA Rx only

Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)

Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fm

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Medtronic® is a registered trademark of Medtronic, Inc.! USA FCC InformationThe following is communications regulation informationon the Model 37751 Recharger.

FCC ID: LF537751

This device complies with part 15 of the FCC 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 undesiredoperation.IMPORTANT: Changes or modifications to thisproduct not authorized by Medtronic, Inc., couldvoid the FCC Certification and negate your authorityto operate this product.

This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to thefollowing two conditions: (1) this device may not causeinterference, and (2) this device must accept anyinterference, including interference that my causeundesired operation of the device.



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Label symbolsExplanation of symbols on products andpackaging. Refer to the appropriate product tosee symbols that apply.

Consult instructions for use

Manufacturer

XXX °FXX °C

-XX °F-XX °C

Temperature limitation

Serial number

MR Magnetic Resonance (MR) Unsafe

Non-ionizing electromagnetic radiation

IEC 60601-1/EN60601-1, Type BFEquipment

Chinese Standard (SJ/T11364-2006)Logo: Electronic Information ProductsPollution Control Symbol. (The date in thislogo means the environmental protectionuse period of the product.)

System meets the applicable Canadian(CAN/CSA-C22.2 No. 60601-1) and US

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(UL 60601-1) electrical safety standardrequirements.

The model 37761 meets the applicableCanadian (CAN/CSA-C22.2 No. 60601-1)and US (UL 60601-1) electrical safetystandard requirements.

Caution, consult accompanyingdocuments

Conformité Européenne (EuropeanConformity). This symbol means that thedevice fully complies with AIMD Directive90/385/EEC (NB 0123) and R&TTEDirective 1999/5/EC.

EC REP Authorized Representative in theEuropean Community

For USA audiences only

Do not dispose of this product in theunsorted municipal waste stream. Disposeof this product according to localregulations. See http://recycling.medtronic.com for instructions onproper disposal of this product.

Rechargeable battery

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Table of contentsLabel Symbols 3

Glossary 8

1 Introduction 12Purpose of the device 12Warnings 12Precautions 13How to use this manual 17Components of your chargingsystem 18Recharger keys 21Recharger screens 22

2 Using your charging system 26Battery and charging information 26

Recharger and neurostimulator 26Recharger 27Neurostimulator 27

Neurostimulator battery status 28Charging your neurostimulatorbattery 32

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Accessories 39Using the recharger pouch 39Using the charging system carryingcase 40

Identification label 40Additional features (available for someneurostimulator models) 40

Turning the neurostimulator on and offwhile charging 40

3 Troubleshooting 44Recharger screens 44

Warning screens 44Information screens 49

Possible problems and solutions 56User assistance 65

4 Maintenance 68Recharger maintenance tasks 68

Checking the recharger battery 68Charging your recharger battery 70

Cleaning and Care 74Safety and technical checks 75Battery and device disposal 75

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Declaration of conformity 76Specifications 76

Index 79

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GlossaryCaution - A statement describing actions that

could result in damage to or improperfunctioning of a device.

Clinician - A healthcare professional such asa doctor or nurse.

Contraindication - A condition orcircumstance when a person should nothave a neurostimulation system.

Discharged battery - The rechargeablebattery is depleted and should be chargedas soon as possible. When the battery is ina discharged state, therapy is notavailable.

Indication - The purpose of theneurostimulation system and the medicalcondition for which it may be implanted.

Neurostimulator - The power source of aneurostimulation system. It contains thebattery and electronics that control thestimulation.

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Overdischarge - The rechargeable batterycannot be recharged when it isoverdischarged. Once a battery is in adischarged state, if it is not recharged itcontinues to lose charge.

Patient Programmer - A hand-held devicethat allows you to check yourneurostimulator battery daily. It is also usedto adjust some of the stimulation settings.

Precaution - See Caution.

Recharger - The component of theneurostimulation system that is used tocharge your neurostimulator battery.

Template - The cut-out area in the plastic partof the charging system belt.

Warning - A statement describing an action orsituation that could harm the patient.

Warning screen - A screen displayed on therecharger that alerts you to a problem withthe charging system.

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1 Introduction



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Purpose of the deviceThe Medtronic Model 37751 Charging Systemis designed to charge Medtronic rechargeableneurostimulators. The indications,contraindications, risks and benefits,warnings, precautions, and individualization oftreatment information for your specificneurostimulation system are located in thepatient programmer user manual supplied withyour patient programmer.

WarningsWound contact—DO NOT use the rechargeron an unhealed wound. The recharger,antenna, and belt or holster are not sterile, andcontact with the wound may cause aninfection.

AC power supply—Do not use the AC powersupply near water or during a lightning storm.Electric shock, serious injury, or death mayresult.

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PrecautionsLow battery charge level—Charge theneurostimulator when you see a Low batteryscreen displayed on the patient programmer orrecharger.The battery charge level is at 0 andyour therapy will stop soon unless yourecharge the battery.

If you see the following screen (Figure 1.1), theneurostimulator battery is in a discharged stateand your therapy has stopped.

Figure 1.1 Neurostimulator battery is in a discharged state.

You should charge the battery as soon aspossible. If the battery remains in a dischargedstate, it continues to lose charge and it willbecome overdischarged.

If the neurostimulator battery is allowed tooverdischarge, you may not be able to

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recharge or communicate with theneurostimulator; however, your doctor may beable to restore the battery function.

Allowing the neurostimulator battery tooverdischarge will permanently affect theneurostimulator in one of the following ways:

• Battery function is restored; however,charging sessions may be more frequentbecause battery capacity has beenreduced.

• Battery function is not restored and theneurostimulator must be surgicallyreplaced. Battery function is not restoredbecause:

– the neurostimulator battery ispermanently damaged.

– the neurostimulator battery has beenoverdischarged and restored twicebefore. The third time the battery isoverdischarged, the neurostimulator willreach end of service. Surgery is requiredto replace the neurostimulator.

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Battery charge level—Check battery statusand charge the battery regularly. Batterycapacity will continue to slowly drain, evenwhen the neurostimulator is off.

Storage temperature: recharger andantenna—Do not expose the recharger orantenna 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 totemperature extremes and can becomedamaged.

Component compatibility (recharger)—Useonly the Medtronic Neurological chargingsystem components to charge your recharger.Use of components other than Medtroniccharging system components to charge therecharger can damage your charging systemcomponents.

Patient device use—When operating anexternal neurostimulator, patient programmer,or charging system, use special care nearflammable or explosive atmospheres. Aninteraction between the flammable or

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explosive atmospheres and the battery in thedevice could occur. The consequences ofusing a battery-powered device nearflammable or explosive atmospheres areunknown.

Equipment modification—Do not modify thisequipment. Modification of this equipment canresult in damage to the device, causing thedevice to malfunction or become unusable.

Interference from EMI—When using therecharger to communicate with yourneurostimulator, move away from equipmentthat may generate electromagneticinterference (EMI) or turn off the likely sourceof EMI. EMI may disrupt communicationbetween the recharger and neurostimulator.Examples of EMI sources are computermonitors, cellular telephones, and motorizedwheelchairs.

Recharger use—Check for skin irritation orredness near the neurostimulator duringrecharging. Do not sit or lie on the antenna, orapply excessive pressure to the antenna. Takeperiodic breaks during prolonged recharging.

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Although no direct cause and effect has beenestablished, some patients have reportedheating sensation, discomfort, blistering notcaused by heating, skin irritation, or rednessnear the implanted neurostimulator during orafter recharging.

For additional information, refer to Table 3.4"Possible problems" on page 63.

How to use this manualThis manual is designed to help youunderstand your charging system. Ask yourclinician to explain anything that is unclear.

• Chapter 1 "Introduction", describes therecharger keys and screens and how thesystem works.

• Chapter 2 "Using your charging system",describes the recharger and how toperform specific tasks.

• Chapter 3 "Troubleshooting", describesrecharger warning and informationscreens, how to solve possible charging

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system problems, and who to contact ifyour recharger is lost or broken.

• Chapter 4 "Maintenance", describes how tocare for your recharger and containssystem specifications and batteryinformation.

• A glossary is provided at the beginning ofthis manual.

Components of your chargingsystem

Recharger

AC Power supply

Antenna

Power cord

Figure 1.2 Components of your charging system.

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Recharger: The recharger is a hand-helddevice used to charge the battery in yourneurostimulator. The display on the rechargerprovides information on your chargingsystem.

Recharger battery: The recharger is used tocharge your implanted neurostimulatorbattery. The recharger has its ownrechargeable battery that is similar to therechargeable batteries commonly found inelectronic devices. The recharger batterytypically lasts for approximately 5 years,depending upon your therapy needs and howoften you use your recharger.

Rechargeable batteries lose some of theirpower every day, even when not used.Charging sessions using the AC power supplyand power cord restore power to the rechargerbattery. You can charge the recharger batteryanytime, including during a recharging sessionfor your neurostimulator.

AC power supply and power cord (Model37761): This device is used to charge therecharger using AC power. If you need to

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charge your neurostimulator but yourrecharger battery is low, connect yourrecharger to the AC power supply to conduct acharging session. The power cord plugs intoan electrical outlet and connects the AC powersupply to the recharger.

Note: Use only the power supply provided byMedtronic with your charging system.

Antenna: The antenna is connected to therecharger and is used to establishcommunication with your neurostimulator. Youcan adjust a dial on the antenna to improve thecharging efficiency between the recharger andthe neurostimulator.

Belt: If your neurostimulator is implanted inyour abdominal area, then you will be given abelt to allow you to keep the antenna directlyover your neurostimulator during a chargingsession.

Holster: If your neurostimulator is implanted inyour upper chest area, then you will be givena holster to allow you to keep the antenna

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directly over your neurostimulator during acharging session.

Pouch: The recharger fits into a pouch thatcan be attached to a belt around your waist.

System carrying case: The carrying case isused to store the recharger, the chargingsystem components, and your patientprogrammer.

Recharger keysThree keys on the recharger allow you tocontrol the recharger.

Start charge/test

Stop charge

Audio control

Figure 1.3 Recharger keys.

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• Audio control : Turns your rechargeron. When your recharger is on, pressingthe Audio control key turns audible statustones on and off.

• Start charge/test : Begins chargingthe neurostimulator.

• Stop charge : Ends or interruptscharging the neurostimulator.

Recharger screensThe recharger screen displays informationabout your charging session (see Figure 1.4).

Neurostimulatorcharging

session screen

Rechargercharging

session screen

Status row

Chargeprogress row

Chargeefficiency row

Figure 1.4 Recharger screens.

Status row — Displays icon information for therecharger and neurostimulator.

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During a neurostimulator or rechargercharging session, you will usually see thefollowing icons on the Status row:

• Neurostimulator is on or off . If thestimulation status is unknown, this area ofthe screen will be blank.

• Audio (sound) is on or off .

• Battery charge status of the recharger (icons show from “needs

recharging” to “full,” respectively).

• The recharger is plugged into the AC powersupply . If the recharger is not pluggedinto a power supply, this area of the screenwill be blank.

Charge progress row — Indicates theprogress of the charging session.

During a neurostimulator charging session,you will see the following icon on the Chargeprogress row: a flashing Battery icon ,indicates the neurostimulator battery ischarging.

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During a recharger charging session, you willsee the following icons on the Chargeprogress row:

• A flashing Battery icon indicates therecharger is charging.

• The Connection icon , indicates that thepower supply is connected to anoperational electrical outlet.

Charge efficiency row — Indicates theefficiency of the charging signal between theneurostimulator and recharger. During aneurostimulator charging session, the moresolid black boxes that appear on theCharge efficiency row, the more efficient thecharging signal and the shorter the chargingsession will be. If you see 6 or more emptyboxes , adjust the antenna to improvethe signal strength between theneurostimulator and the recharger.

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2 Using yourcharging system



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This chapter includes information on:

• the recharger battery and the chargingprocedure.

• the neurostimulator battery status icons.

• charging your neurostimulator.

• the charging system accessories.

• the charging system optional features.

Battery and charginginformation

Recharger and neurostimulator

• Charge the recharger and neurostimulatoreven if you are not using them for anextended period of time.

• You can charge the neurostimulator andrecharger at the same time. Follow theinstructions for both procedures ("Chargingyour neurostimulator battery" on page 32and "Charging your recharger battery" onpage 70) at the same time.

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• Charge the batteries in your recharger andneurostimulator before they are low.

Recharger

• The recharger battery might have run lowsince it was manufactured and shipped.You might need to charge it before you useit the first time.

• As your recharger ages, you will need tocharge the battery more often.

Neurostimulator

• Your ability to locate your neurostimulatorand the depth of the neurostimulatordetermine the efficiency of the chargingsession. With practice, you will find the bestlocation on your skin for placing yourrecharger and antenna.

• If your neurostimulator is on while you arecharging the battery, your charging sessionmight last longer.

• Depending on your therapy needs,charging your neurostimulator could take

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from one hour to more than 12 hours perweek.

• You can partially charge yourneurostimulator if you do not have enoughtime for a complete charging session.

• You can charge your neurostimulator atany time; you do not have to wait for a lowbattery message.

• Depending on where your neurostimulatoris implanted, you will be given a belt that isplaced around your waist or a holster thatis placed over your shoulder to hold theantenna in place during your chargingsession.

Neurostimulator battery statusUse your patient programmer to check yourneurostimulator battery charge level everyday. Refer to the manual supplied with thepatient programmer.

The recharger will also indicate if yourneurostimulator battery needs to berecharged. If either message in Table 2.1 is

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displayed on the recharger, recharge theneurostimulator battery immediately.

Table 2.1 When to charge the neurostimulator

When you see this It means

The neurostimulator batterycharge level is low, and soonyour therapy will not beavailable.

Charge the neurostimulatorbattery. Press the gray Audiokey on the recharger to clearthe message.

The neurostimulator batterycharge level is depleted; thebattery is in a discharged state.Therapy has stopped.

Charge the neurostimulatorbattery now. Press the greenStart charge/test key to clearthe screen.

# Caution: Charge the neurostimulator whenyou see a Low battery screen displayed onthe patient programmer or recharger.Thebattery charge level is at 0 and your therapy

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will stop soon unless you recharge thebattery.

If you see the following screen(Figure 2.1), the neurostimulator battery isin a discharged state and your therapy hasstopped.


You should charge the battery as soon aspossible. If the battery remains in adischarged state, it continues to losecharge and it will become overdischarged.

If the neurostimulator battery is allowed tooverdischarge, you may not be able torecharge or communicate with theneurostimulator; however, your doctor maybe able to restore the battery function.

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Allowing the neurostimulator battery tooverdischarge will permanently affect theneurostimulator in one of the followingways:

• Battery function is restored; however,charging sessions may be morefrequent because battery capacity hasbeen reduced.

• Battery function is not restored and theneurostimulator must be surgicallyreplaced. Battery function is notrestored because:


– the neurostimulator battery has beenoverdischarged and restored twicebefore. The third time the battery isoverdischarged, the neurostimulatorwill reach end of service. Surgery isrequired to replace theneurostimulator.

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Charging your neurostimulatorbatteryCheck with your clinician prior to using yourrecharger for the first time. When yourneurostimulator needs to be charged, followthe steps below.

Notes:

• You might need to charge the rechargerbattery before you charge yourneurostimulator battery. Refer to"Recharger maintenance tasks" onpage 68.

• Based on the position of your implantedneurostimulator, you might need to usemore than one template (Figure 2.2) toensure the antenna remains positionedcorrectly over your neurostimulator.

• Based on the location of your implantedneurostimulator, you will use either a beltaround your waist or a holster over yourshoulder to hold the antenna in place.

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• Do not place the antenna over bulkyclothing or bandages.

• The antenna may be placed directly onyour skin. However, if the antenna irritatesyour skin, you might want to wear a thinundergarment to protect your skin.

1. Press your skin where your neurostimulatoris located to determine the best place forthe antenna.

2. Put on your belt or holster, with thetemplate or opening centered over yourneurostimulator (Figure 2.2) and secure itin place. Reposition the template oropening, if necessary.

Implantedneurostimulator

Template

Figure 2.2 Place the belt or holster over your neurostimulator.

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3. Place the antenna in the template oropening, and press it into the belt or holsteruntil it snaps into place (Figure 2.3).

Antenna

Figure 2.3 Attach the antenna.

4. Press the green Start charge/test keyon the recharger.

a. The Recharger wait screen will appearon the recharger display (Figure 2.4).The Recharger wait screen indicatesthat the neurostimulator and rechargerare trying to communicate.

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Figure 2.4 Recharger wait screen.

b. When charging begins, theNeurostimulator charging sessionscreen will appear. This screenindicates the neurostimulator batterycharge level and efficiency of thecharging session (Figure 2.5).

Neurostimulatorbattery chargelevel

Chargingefficiency

Figure 2.5 Neurostimulator charging session screen.

c. The Battery charge level updatesthroughout the charging session(Figure 2.6). Charging sessions cantake from a few minutes to more than 12

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hours, depending on the chargingefficiency, how often you charge, andyour therapy needs.

Nocharge

Fullcharge

Figure 2.6 Battery charge levels.

Notes:

– If you need to interrupt your chargingsession, press the Stop charge key on the recharger.

– You might hear periodic clicking noisesduring recharging, and you might seethe screen refresh.

5. Check the progress of the charging sessionby reviewing the icons on your rechargerscreen. If you see 6 or more empty boxes

, reposition the antenna or use thedial on the antenna to try to make thesession more efficient.

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a. Turn the dial on the antenna one quarterturn in either direction (Figure 2.7).

Figure 2.7 Adjusting the antenna dial.

b. Press the green Start charge/test key. The recharger will display anupdated efficiency status.

c. Repeat step a and b above until therecharger screen indicates a moreefficient charging session.

Note: Charging efficiency is affected byfactors such as implant depth and location,and efficiency will vary between patients.You and your clinician can work together tooptimize your recharging efficiency.

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6. Periodically check the progress of thecharging session by reviewing the icons onyour recharger screen.

7. When your neurostimulator has a chargesufficient for use, you will see theNeurostimulator charge sufficientscreen (Figure 2.8)

Figure 2.8 Neurostimulator charge sufficient screen.

8. You can press the Stop charge key to stopyour charging session, if desired. You willhear multiple tones if the audio is on. If youwait for the system to fully charge yourneurostimulator, the Neurostimulatorcharge complete screen will appear on therecharger display (Figure 2.9), and you willhear multiple tones, if the audio is on.

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Figure 2.9 Neurostimulator charge complete screen.

9. Carefully release the antenna from thetemplate or opening and remove theantenna from the belt or holster.

10.Remove the belt or holster and store it, theantenna, and the recharger in the chargingsystem carrying case.

Accessories

Using the recharger pouch

The recharger comes with a small pouch thatyou can wear on a belt or holster to hold therecharger during a charging session.

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Using the charging system carryingcase

The recharger comes with a carrying case tostore the recharger and accessories. Using thecase keeps the components clean and freefrom damage.

Identification labelPlace an identification label on the back of yourrecharger in case the recharger is lost.

Additional features (availablefor some neurostimulatormodels)

Turning the neurostimulator on andoff while charging

If you have an implantable neurostimulator forpain therapy, you can use the recharger to turnyour neurostimulator on and off during acharging session. Use the two keys on the sideof the recharger to turn your neurostimulatoron and off.

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Neurostimulator ON

Neurostimulator OFF

Figure 2.10 Neurostimulator ON and OFF keys.

To turn the neurostimulator on while charging:

1. Press the Neurostimulator ON key.

2. If audio is enabled, listen for theconfirmation tone.

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 key.

2. If audio is enabled, listen for theconfirmation tone.

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3. Verify that the Neurostimulator OFF icon is displayed on the recharger screen.

Note: If you want to adjust stimulation usingyour patient programmer before yourneurostimulator is completely charged, pressthe Stop charge key on the recharger.You might need to remove the antenna so yourpatient programmer can communicate withyour neurostimulator. Adjust stimulation withyour patient programmer. Resume thecharging session by pressing the Startcharge/test key.

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3Troubleshooting



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This section will help you solve problems withyour charging system. It also providesinformation on when to call your clinician orMedtronic.

Note: If you cannot solve a problem, or if aproblem is not described here, contact yourclinician.

Recharger screensThe recharger displays Warning andInformation screens to provide you withinformation about your system, alert you to aproblem with your system, or to guide youduring recharger use.

Warning screens

Warning screens indicate a problem withthe recharger, the antenna, or theneurostimulator. If the audio is on, multipletones alert you to the screen. Table 3.1describes Warning screens and providesinstructions (see blue text) on how to resolvethe problem.

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# Caution: Charge the neurostimulator whenyou see a Low battery screen displayed onthe patient programmer or recharger.Thebattery charge level is at 0 and your therapywill stop soon unless you recharge thebattery.

If you see the following screen(Figure 3.1), the neurostimulator battery isin a discharged state and your therapy hasstopped.


You should charge the battery as soon aspossible. If the battery remains in adischarged state, it continues to losecharge and it will become overdischarged.

If the neurostimulator battery is allowed tooverdischarge, you may not be able to

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recharge or communicate with theneurostimulator; however, your doctor maybe able to restore the battery function.

Allowing the neurostimulator battery tooverdischarge will permanently affect theneurostimulator in one of the followingways:

• Battery function is restored; however,charging sessions may be morefrequent because battery capacity hasbeen reduced.

• Battery function is not restored and theneurostimulator must be surgicallyreplaced. Battery function is notrestored because:


– the neurostimulator battery has beenoverdischarged and restored twicebefore. The third time the battery isoverdischarged, the neurostimulatorwill reach end of service. Surgery is

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required to replace theneurostimulator.

Table 3.1 Recharger Warning screens

Warning screen Cause and action

Charge yourneurostimulatorbattery

The neurostimulator batterycharge level is depleted; thebattery is in a discharged state.Therapy has stopped.

Press the green Start charge/test key to clear the screen.

Charge the neurostimulatorbattery now.

Charge yourrecharger battery

Your recharger battery charge isinsufficient to charge yourneurostimulator.

Connect the recharger to theAC power supply to clear thescreen.

Charge your recharger now.

Incompatibleneurostimulator

Your neurostimulator isincompatible with the recharger,and the recharger cannot beused to charge yourneurostimulator.

Call your clinician.

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Table 3.1 Recharger Warning screens (continued)

Warning screen Cause and action

Call doctor Your neurostimulator hasreached end of service.Stimulation has stopped.

Call your doctorimmediately.

Call clinician Your system is not workingcorrectly. Stimulation mighthave stopped.

Call your clinician andprovide the specific errorcode shown on the rechargerdisplay.

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Information screens

Information screens provide informationand instructions on how to proceed. If the audiois on, multiple tones alert you to the message.Press the Audio key on the recharger to clearthe information screen. Table 3.2 describesinformation screens.

Table 3.2 Recharger Information screens

Information screen Description and action

Reposition antenna The communication betweenyour recharger and yourneurostimulator was interruptedor could not be established.

Reposition your antenna overyour neurostimulator, andpress the green Start charge/test key.

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Table 3.2 Recharger Information screens (continued)


Check antenna The antenna connection to therecharger is loose or yourantenna is not connected.

Check that the antenna andrecharger are making fullcontact. Connect or tightenthe connection and retry.

The antenna or recharger mightrequire service.

Call Medtronic. Refer to theaddresses and phonenumbers on the inside backcover of this manual.

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Move to a coolerenvironment; ensureyour system is not toohot

Your antenna is too hot to workproperly.

Allow the antenna to cool.Store the charging systemcomponents in a cool, dryplace.

Your skin is too warm for asuccessful charging session.

Move to a cool location,remove any excess clothing,allow your skin temperatureto cool.

The antenna may requireservice.

Contact Medtronic. Refer tothe addresses and phonenumbers on the inside backcover of this manual.

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Note: This screen might appear during a rechargingsession, even if the antenna surface does not feel warmto you. Recharging will stop when this screen is displayedbecause the antenna is too warm for the system to workproperly. Recharging will begin again once the surfacetemperature of the recharger antenna is within theoperating range of the system.

Physician rechargerinformation

AL

An incorrect combination ofkeys was pressed. This screenis for physician use only.

Press the Stop charge key toclear this message.

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Charge yourneurostimulator

The neurostimulator batterycharge level is low andstimulation will stop soon.

Charge your neurostimulatorbattery using the recharger.

Charge yourrecharger

The recharger battery chargelevel is low.

Charge your rechargerbattery using the AC powersupply.

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Finishneurostimulatorcharging session

The neurostimulator battery isonly partially charged.

You did not completelycharge the neurostimulatorbattery. Finish charging yourneurostimulator battery usingthe recharger, if desired.

Finish rechargercharging session

The recharger battery is onlypartially charged.

You did not completelycharge the recharger battery.Finish charging yourrecharger battery using theAC power supply, if desired.

Neurostimulatorcharging complete

The neurostimulator batterycontains sufficient charge foruse.

Press the Audio key to clearthe message.

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Recharger chargingcomplete

The recharger battery is fullycharged.

Press the Audio key to clearthe message.

Call clinician There is a problem with acomponent of your system.

Call your clinician andprovide the specific errorcode shown on the rechargerdisplay.

Call clinician Your neurostimulator needs tobe replaced, becausestimulation will stop soon.

Call your clinician andprovide the message shownon the recharger display.

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POR

POR

Your neurostimulator hasundergone a power-on-reset.

Call your clinician andprovide the message shownon the recharger display.

Reposition antenna Your neurostimulator can beturned on and off with therecharger. You tried to turn yourneurostimulator on or off, but therecharger did not communicatesuccessfully with theneurostimulator.

Reposition your antenna overyour neurostimulator. Tryagain to turn yourneurostimulator on or off.

Possible problems andsolutionsThe following table will help you solveproblems or identify when to call your clinician.

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Problems are described in the left column(bold black text). The right column listspossible causes of the problem (plain text) andhow to correct the problem (bold blue text).

Note: If a problem is not resolved after severalattempts or if a problem is not described in thefollowing table, contact your clinician.

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Tab

le 3

.3 T

rou

ble

sh

oo

tin

g

Pro

ble

ms

Cau

ses

an

d a

ctio

ns

Yo

ur

rech

arg

ers

cre

en d

oes

no

t tu

rno

n w

hen

yo

u t

ry t

oc

ha

rge

you

rn

euro

stim

ula

tor

The

rec

harg

er b

atte

ry is

low

.

Att

ach

th

e A

C p

ow

er s

up

ply

to

th

e r

ech

arg

er.

The

rec

harg

er

is b

roke

n.

Co

nta

ct y

ou

r d

oct

or.

Yo

u s

pill

flu

id o

n y

ou

rre

char

ger

, an

ten

na,

or

AC

po

we

r su

pp

ly

If t

he

AC

po

wer

su

pp

ly is

plu

gg

ed

into

an

ele

ctri

cal

ou

tlet

, in

terr

up

t th

e f

low

of

elec

tric

ity

to

th

e o

utl

et.

Un

plu

g t

he

po

wer

su

pp

ly.

Dry

th

e co

mp

on

en

t w

ith

a t

ow

el.

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Tab

le 3

.3 T

rou

ble

sho

oti

ng

(co

nti

nu

ed)

Pro

ble

ms

Cau

ses

an

d a

ctio

ns

Yo

ur

AC

po

wer

su

pp

ly w

ill n

ot t

urn

on

(th

e li

gh

t o

n t

he

su

pp

ly d

oes

no

t tu

rng

reen

wh

en y

ou

plu

git

in

)

The

pow

er c

ord

mig

ht n

ot b

e p

lugg

ed in

to th

e A

C p

owe

rsu

ppl

y o

r el

ectr

ica

l out

let.

Co

nn

ect

the

po

we

r c

ord

to

th

e el

ectr

ica

l ou

tlet

.

The

con

nec

tion

to t

he p

ow

er c

ord

mig

ht b

e lo

ose.

Res

eat

the

ele

ctri

cal c

ord

on

th

e A

C p

ow

er s

up

ply

.

The

pow

er c

ord

conn

ecte

d to

the

AC

pow

er

supp

ly m

ight

be

inco

mp

atib

le w

ith t

he e

lect

rica

l out

let.

Ob

tain

an

ad

ap

ter

for

the

typ

e o

f el

ect

rica

l ou

tlet

yo

ua

re u

sin

g.

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Tab

le 3

.3 T

rou

ble

sho

oti

ng

(co

nti

nu

ed)

Pro

ble

ms

Cau

ses

an

d a

ctio

ns

Yo

ur

rech

arg

er o

ra

nte

nn

a fa

lls i

nto

wa

ter

1.

If t

he

AC

po

wer

su

pp

ly is

plu

gg

ed

into

an

ele

ctri

cal o

utl

et, i

nte

rru

pt t

he

flo

w o

f ele

ctri

city

toth

e o

utl

et.

Un

plu

g t

he

po

wer

su

pp

ly.

2.

Rem

ove

th

e r

ech

arg

er o

r an

ten

na

fro

m t

he

wat

er.

3.

If t

he

rec

ha

rger

or

an

ten

na

is d

irty

, wip

e it

wit

h a

tow

el

da

mp

ened

wit

h c

lean

wat

er.

4.

Sh

ake

th

e re

cha

rger

or

ante

nn

a.

5.

If y

ou

see

or

he

ar w

ate

r in

sid

e, w

ipe

it d

ry w

ith

ac

lean

to

wel

. R

epea

t st

eps

4 a

nd

5.

6.

Wh

en t

he

rech

arg

er o

r an

ten

na

is d

ry, t

ry t

o u

se

it.

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Tab

le 3

.3 T

rou

ble

sho

oti

ng

(co

nti

nu

ed)

Pro

ble

ms

Cau

ses

an

d a

ctio

ns

Yo

ur

AC

po

wer

su

pp

ly f

alls

into

wa

ter

1.

If t

he

AC

po

wer

su

pp

ly is

plu

gg

ed

into

an

ele

ctri

cal o

utl

et, i

nte

rru

pt t

he

flo

w o

f ele

ctri

city

toth

e o

utl

et.

Un

plu

g t

he

po

wer

su

pp

ly.

2.

Rem

ove

th

e A

C p

ow

er s

up

ply

fro

m w

ater

.

3.

If i

t is

dir

ty, w

ipe

it w

ith

a t

ow

el d

amp

en

ed

wit

hc

lean

wat

er.

4.

Lea

ve t

he

AC

po

wer

su

pp

ly o

n a

dry

to

wel

fo

r a

few

ho

urs

.

5.

Sh

ake

th

e A

C p

ow

er s

up

ply

. If

yo

u s

ee o

r h

ear

wat

er in

sid

e, r

epea

t st

eps

4 a

nd

5 u

nti

l th

e p

ow

er

su

pp

ly i

s t

ho

rou

gh

ly d

ry.

6.

Plu

g t

he

po

wer

co

rd i

nto

a g

rou

nd

ed e

lec

tric

alo

utl

et. A

gre

en

lig

ht

on

th

e to

p o

f th

e p

ow

er

su

pp

ly w

ill c

om

e o

n if

it

is w

ork

ing

pro

per

ly.

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Tab

le 3

.3 T

rou

ble

sho

oti

ng

(co

nti

nu

ed)

Pro

ble

ms

Cau

ses

an

d a

ctio

ns

Yo

ur

rech

arg

er,

an

ten

na,

or

AC

po

wer

su

pp

ly f

alls

off

ac

abin

et o

r ta

ble

The

rec

harg

er,

ante

nna

, an

d A

C p

owe

r su

pply

are

des

ign

ed t

o w

ithst

and

falls

of

shor

t di

stan

ces.

Try

the

rec

har

ger

, an

ten

na,

or

AC

po

wer

su

pp

ly; t

he

ys

ho

uld

wo

rk.

Yo

ur

rech

arg

er i

sb

eep

ing

You

can

not

reso

lve

the

prob

lem

or y

ou

see

a s

cree

n o

ther

than

tho

se d

escr

ibed

in t

his

sect

ion.

Co

nta

ct y

ou

r c

linic

ian

to

re

solv

e t

he

pro

ble

m.

Yo

ur

rech

arg

ers

cre

en is

bla

nk

The

Re

char

ger

wa

it s

cree

n d

id n

ot a

ppe

ar w

hen

you

pre

ssed

the

Sta

rt c

har

ge/

test

ke

y.

Co

nn

ect

yo

ur

rec

ha

rger

to

th

e A

C p

ow

er s

up

ply

an

dfo

llow

th

e d

irec

tio

ns

for

cha

rgin

g y

ou

r re

char

ger

on

pag

e 7

0.

No

te:

If t

he

Rec

ha

rger

ch

arg

ing

sc

ree

n d

oes

no

ta

pp

ear

aft

er y

ou

co

nn

ect

the

rec

har

ger

to

th

e A

Cp

ow

er s

up

ply

, co

nta

ct y

ou

r c

linic

ian

.

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Tab

le 3

.4 P

oss

ible

pro

ble

ms

Pro

ble

ms

Cau

ses

an

d a

ctio

ns

Yo

u e

xper

ien

ceh

eati

ng

sen

sati

on

,d

isco

mfo

rt,

blis

teri

ng

no

t ca

use

d b

yh

eati

ng

, sk

inir

rita

tio

n,

or

red

nes

sn

ear

the

imp

lan

ted

neu

rost

imu

lato

rd

uri

ng

or

afte

rre

cha

rgin

g.

You

r su

rgic

al w

oun

d is

not

ful

ly h

eale

d.

Sto

p r

ech

arg

ing

. If

skin

irr

itat

ion

per

sist

s, c

on

tact

yo

ur

clin

icia

n.

The

be

lt or

ho

lste

r is

too

tig

ht a

nd c

reat

ing

too

muc

hp

ress

ure

on

you

r sk

in f

rom

the

ant

enna

.

Lo

ose

n t

he

be

lt o

r h

ols

ter

so

th

at

it i

s c

om

fort

able

an

d o

nly

tig

ht

eno

ug

h t

o s

ecu

re t

he

ante

nn

a i

np

lace

.

You

are

sitt

ing

or

lyin

g o

n th

e a

nte

nna.

Mo

ve t

o a

po

siti

on

wh

ere

yo

u a

re n

ot

sit

tin

g o

r ly

ing

on

th

e an

ten

na.

You

exp

erie

nce

skin

irrit

atio

n c

ause

d b

y di

rect

co

ntac

tw

ith t

he a

nte

nna.

Wea

r a

th

in u

nd

erg

arm

en

t o

r p

lac

e a

th

in p

iec

e o

ffa

bri

c b

etw

een

yo

ur

skin

an

d t

he

ante

nn

a. Y

ou

may

als

o w

ant

to t

ry u

sin

g m

ore

th

an

on

e te

mp

late

to

mo

ve

the

an

ten

na

furt

her

aw

ay f

rom

th

e s

kin

.

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Tab

le 3

.4 P

oss

ible

pro

ble

ms

(co

nti

nu

ed)

Pro

ble

ms

Cau

ses

an

d a

ctio

ns

Yo

u e

xper

ien

ceh

eati

ng

sen

sati

on

,d

isco

mfo

rt,

blis

teri

ng

no

t ca

use

d b

yh

eati

ng

, sk

inir

rita

tio

n,

or

red

nes

sn

ear

the

imp

lan

ted

neu

rost

imu

lato

rd

uri

ng

or

afte

rre

cha

rgin

g.

(co

nti

nu

ed)

You

hav

e be

en

rech

arg

ing

for a

long

tim

e w

itho

ut a

bre

aka

nd a

re f

eelin

g d

isco

mfo

rt.

If s

kin

re

dn

ess

occ

urs

, tak

e a

bre

ak f

rom

re

char

gin

glo

ng

en

ou

gh

fo

r y

ou

r sk

in t

o r

eco

ver.

Du

rin

g l

on

ger

rech

arg

ing

ses

sio

ns,

tak

e p

erio

dic

bre

aks

an

dre

mo

ve t

he

re

char

ge

r fr

om

yo

ur

skin

.

If a

ny

of t

he

se s

ym

pto

ms

are

se

vere

, sto

p r

ech

arg

ing

an

d c

on

tact

yo

ur

clin

icia

n.

Yo

u e

xper

ien

ceu

nco

mfo

rta

ble

war

mth

.

The

re is

not

eno

ugh

air

flow

acr

oss

the

bac

k of

the

ant

enna

to

kee

p it

cool

.

En

sure

th

at t

he

ba

ck o

f th

e an

ten

na

is e

xpo

sed

to

op

en a

ir d

uri

ng

rec

har

gin

g.

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User assistanceYour recharger has been designed and testedto provide trouble-free service. If repair orservice is needed, contact your clinician or aMedtronic sales office. Refer to the list ofMedtronic contacts at the end of this manual.

The serial number is located on the back of therecharger. This number identifies eachrecharger. If you contact Medtronic about yourrecharger, refer to the serial number.

If your recharger stops working - First try thesteps in Table 3.3. Otherwise, contactMedtronic.

If you lose your recharger - Contact yourclinician to order a new recharger.

To register the recharger for servicecovered by the warranty, complete and mailthe warranty registration.

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4 Maintenance



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This section describes how to care for anddispose of your recharger and accessories.

Recharger maintenance tasksMaintaining the battery in your rechargerensures that you will be able to charge yourneurostimulator battery when needed. Forinformation on charging and the batterieswithin the recharger, see "Battery and charginginformation" on page 26.

Checking the recharger battery

Press the gray Audio key on the recharger toturn on your recharger and check therecharger battery charge level. TheRecharger battery charge level screendisplays the current battery charge level(Figure 4.1).

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Battery charge level

Needscharging

Fullcharge

Figure 4.1 Recharger battery charge level screen and icons.

Charge your recharger with the AC powersupply when you see either of the screens inTable 4.1.

Table 4.1 When to charge the recharger


The recharger battery chargelevel is low and will lose powersoon. Charge the rechargerbattery.

Press the Audio key to clearthe message, and charge therecharger battery.

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Table 4.1 When to charge the recharger (continued)


The recharger battery lost or isabout to lose power.

Charge the recharger batteryimmediately.

Charging your recharger battery

Follow the steps below to charge the rechargerbattery using the AC power supply.

1. Plug the AC power supply into an AC outlet(Figure 4.2). A green light indicates it haspower.

w Warning: Do not use the AC powersupply near water or during a lightningstorm. Electric shock, serious injury, ordeath may result.

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Figure 4.2 Plug in the AC power supply.

2. Connect the recharger to the AC powersupply (Figure 4.3). The recharger willautomatically start to charge whenconnected to the AC power supply, and theRecharger charging session screen willbe displayed (Figure 4.4).

Notes:

– The charging session could takeseveral hours, depending on the chargelevel of the batteries.

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– To interrupt a recharger chargingsession, disconnect the recharger fromthe AC power supply.

Figure 4.3 Connect the recharger to the AC power supply.

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Figure 4.4 Recharger charging session screen.

3. When the charging session is complete, theRecharger charging complete screen(Figure 4.5.) will appear.

Figure 4.5 Recharger charging complete screen.

4. Unplug the AC power supply from theelectrical outlet.

5. Disconnect the AC power supply from therecharger.

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

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Cleaning and CareFollow these guidelines to ensure that therecharger system and accessories functionproperly:

• Keep the recharger, antenna, and ACpower supply out of the reach of children.

• Use the recharger, antenna, and AC powersupply only as instructed by your clinicianand this manual.

• Handle the recharger, antenna, and ACpower supply with care. Do not drop, strikeor step on the components.

• Do not dismantle or tamper with therecharger, antenna, or AC power supply.

• Clean the outside of the recharger,antenna, and AC power supply with a dampcloth when necessary. Mild householdcleaners will not damage the components.

• The recharger, antenna, and AC powersupply are not waterproof. Do not allowmoisture to get inside the components.

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• The belt or holster, with the antennaremoved, can be washed with a mildlaundry detergent in a washing machineand dried in a dryer on a low heat setting.

Safety and technical checksPeriodic safety and technical checks orperiodic maintenance of the recharger are notrequired.

The recharger contains no user-serviceableparts. If repair or service is needed, contactyour clinician or a Medtronic sales office. Referto the list of Medtronic contacts at the end ofthis manual.

Battery and device disposalDispose of worn out devices according to localregulations. Do not incinerate. If you no longerneed your recharger and would like to donateit, contact your clinician.

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Declaration of conformityMedtronic declares that this product is inconformity with the essential requirements ofDirective 1999/5/EC on Radio andTelecommunications Terminal Equipment andDirective 90/385/EEC on Active ImplantableMedical Devices.

For additional information, contact Medtronic.Refer to the list of Medtronic contacts at theend of this manual.

SpecificationsThe following table lists the specifications foryour recharger.

Table 4.2 Recharger specifications

Parameter Specification

Power source 2 non-removable lithium-ion batteries(rechargeable)

Operating temperature 10 °C to 35 °C

(50 °F to 95 °F)

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Table 4.2 Recharger specifications (continued)


Temperature limitation –20 °C to 40 °C

(–4 °F to 104 °F)

Recharger size(approximate)

13 cm x 8 cm x 3.18 cm

(5 in x 3 in x 1.25 in)

Recharger weight,including battery(approximate)

227 g (8 oz)

Battery life 5 years (approximate life ofdevice)a

Inputs 0.85 A, 8.4 V DC (charge)

0.5 A, 10 V DC (base)a The longevity of your recharger battery is dependent

upon how often you use your recharger.

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Table 4.3 AC power supply and power cordspecifications


Operating temperature 10 °C to 35 °C

(50 °F to 95 °F)

Temperature limitation –20 °C to 40 °C

(–4 °F to 104 °F)

Power supply voltage 100–240 V (auto-ranging)

Rated frequency 50 Hz, 60 Hz

Input current 0.35 A

Outputs 0.85 A, 8.4 V DC (charge)

0.5 A, 10 V DC (base)

Mode of operation Continuous

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IndexAccessories 39AC power supply

description 19troubleshooting 59, 61, 62

Antennadescription 20troubleshooting 60, 62

Antenna dialabout 20adjusting 36

Audio control key 22Audio tones 38, 44Battery (neurostimulator)see Neurostimulator battery

Battery (recharger)see Recharger battery

Belt 20, 28Care 74Carrying case 21, 40Charge efficiency row 24

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Charge progress row 23Charging efficiency 24, 36-37Charging neurostimulator and recharger at

same time 26Charging session

neurostimulator battery 35-38recharger battery 71-73

Charging systemcleaning and care 74parts 19-21

Charging the neurostimulator batteryprocedure 32-39turning neurostimulator on and off while

charging 40-42Charging the recharger battery 70-73Checking recharger battery 68-70Cleaning 74Dial (antenna)

about 20adjusting 36

Disposing of devices 75Holster 28

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Identification label 40Information screens 49-56Interrupting

neurostimulator battery chargingsessions 36

recharger battery charging session 72Keys, recharger 21Low battery level screen

neurostimulator 44Maintenance 68-73Neurostimulator battery

battery level messages 29, 47charging 32-39checking status 28interrupting charging session 36

see NeurostimulatorNeurostimulator battery (rechargable)

overdischarge 44Neurostimulator

charging information 26-27turning on and off while charging 40-42

see Neurostimulator battery

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Neurostimulator OFF key 41Neurostimulator ON key 41Overdischarge 44Patient programmer 28Pouch 21, 39Power cord 19Power supplysee AC power supply

Recharger batteryabout 19charging 70-73checking charge level 68-70interrupting charging session 72maintaining 68-73See also Recharger 26

Recharger keys 21Recharger

charging information 26description 19possible problems 63troubleshooting 58-62

see Recharger battery

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Recharger screensabout 22-24information screens 49-56Neurostimulator charging session

screen 22Recharger charging session screen 22warning screens 44-48

Recharger systemsee Charging system

Repair 75Screenssee Recharger screens

Serial number 65Specifications 76Start charge/Test key 22Status row 22Stop charge key 21, 22, 36Template 33Test (Start charge/Test) key 22Tones, audio 38, 44Troubleshooting 44-62

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Turning neurostimulator on and off whilecharging 40-42

Warning screens 44-48Warranty registration 65

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Contacts:

Asia: Medtronic International Ltd.Tel. 02919-1362Fax 02907-3998Medtronic Asia Ltd.

Tel. (02)-548-1148Fax (02)-518-4786Australia: Medtronic Australasia Pty.Ltd.97 Waterloo RoadNorth Ryde, NSW 2113AustraliaTel. +61-2-9857-9000Fax +61-2-9878-5100Toll free 1-800-668-6700Austria: Medtronic Österreich GmbHTel. 01-240440Fax 01-24044-100Belgium: Medtronic Belgium S.A.Tel. 02-456-0900Fax 02-460-2667Canada: Medtronic of Canada Ltd.Tel. (1-905)-460-3800Fax (1905)-826-6620Czech Republic: Medtronic Czechias.r.o.Tel. 2-965-795-80Fax 2-965-795-89Denmark: Medtronic Danmark A/STel. 45-32-48-18-00Fax 45-32-48-18-01Finland: Medtronic Finland Oy/LTDTel. (09)-755-2500Fax (09)-755-25018France: Medtronic France S.A.S.Tel. 01-5538-1700Fax 01-5538-1800Germany: Medtronic GmbHTel. (02159)-81490Fax (02159)-8149100Greece: Medtronic Hellas S.A.Tel. 210-67-79-099Fax 210-67-79-399

Hungary: Medtronic Hungária Kft.Tel. 1-889-06-00Fax 1-889-06-99Ireland: Medtronic Ireland Ltd.Tel. (01)-890-6522Fax (01)-890-7220Italy: Medtronic Italia SpATel. 02-241371Fax 02-241381Tel. 06-328141Fax 06-3215812Japan: Medtronic JapanTel. 03-6430-2016Fax 03-6430-7110Latin America: Medtronic, Inc.Tel. (1305)-500-9328Fax (1786)-709-4244Norway: Medtronic Norge ASTel. 067-10-32-00Fax 067-10-32-10Poland: Medtronic Poland Sp. z.o.o.Tel. (022)-465-69-00Fax (022)-465-69-17Portugal: Medtronic Portugal, Lda.Tel. 21-724-5100Fax 21-724-5199Russia: Medtronic RussiaTel. (8495) 580-7377Fax (8495) 580-7378Slovakia Medtronic Slovakia, o.z.Tel. 0268 206 911Fax 0268 206 999Spain: Medtronic Ibérica, S.A.Tel. 91-625-0400Fax 91-650-7410Sweden: Medtronic ABTel. 08-568-585-00Fax 08-568-585-01Switzerland: Medtronic (Schweiz) AGTel. 031-868-0100Fax 031-868-0199



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The Netherlands: Medtronic B.V.Tel. (045)-566-8000Fax (045)-566-8668U.K.: Medtronic U.K. Ltd.Tel. 01923-212213Fax 01923-241004

USA: Medtronic, Inc.Tel. (1763)-505-5000Fax (1763)-505-1000Toll-free: (1-800)-328-0810



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Manufacturer Medtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432-5604USAwww.medtronic.comTel. +1-763-505-5000Fax +1-763-505-1000

Authorized Representative EC REPin the European CommunityMedtronic B.V.Earl Bakkenstraat 106422 PJ HeerlenThe NetherlandsTel. +31-45-566-8000Fax +31-45-566-8668

Europe/Africa/Middle EastHeadquartersMedtronic International Trading SàrlRoute du Molliau 31Case Postale 84CH-1131 TolochenazSwitzerlandwww.medtronic.euTel. +41-21-802-7000Fax +41-21-802-7900

Asia-PacificMedtronic International Ltd.Suite 1106-11, 11/F, Tower 1, The Gateway25 Canton Road, TsimshatsuiKowloonHong KongTel. +852-2919-1362Fax +852-2907-3998

Contacts for specific countries are listedinside this cover.

*M924449A036*© Medtronic, Inc. 2012All Rights ReservedM924449A036



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Documents

Version: 01-18-2012 4.625 x 6.0 inches (117 mm x 152 mm ......XXX °F XX °C-XX °F-XX °C Temperature limitation Serial number MR Magnetic Resonance (MR) Unsafe Non-ionizing electromagnetic