Medtronic 97725 Pain ENS - Wireless External Neurostimulator User Manual

Medtronic, Inc. Pain ENS - Wireless External Neurostimulator

User Manual

Wireless External Neurostimulator 97725User manual! USA   Rx onlyFilename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X2013-04
Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X2013-04
Explanation of symbols on product or package labelingRefer to the appropriate product for symbols that apply.Consult instructions for useDo not reuseUse bySTERILE EOSterilized using ethylene oxideSTERILIZE2Do not resterilizeManufacturerDate of manufactureXXX °FXX °C-XX °F-XX °CTemperature limitationMRMagnetic Resonance (MR) UnsafeNon-ionizing electromagnetic radiationSerial numberChinese Standard (SJ/T11364-2006) Logo: Electronic Information ProductsPollution Control Symbol. (The date in this logo means the environmentalprotection use period of the product.)System meets the applicable Canadian (CAN/CSA-C22.2 No. 60601-1) andUS (UL 60601-1:2003) electrical safety standard requirements.IEC60601-1/EN60601-1, Type BF equipment 2013-04  English 12013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
Conformité Européenne (European Conformity). This symbol means that thedevice fully complies with MDD 93/42/EEC (NB 0123) and R&TTE Directive1999/5/EC.EC REPAuthorized Representative in the European CommunityFor USA audiences onlyDo not use of the package is damaged.Do not dispose of this product in the unsorted municipal waste stream.Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product.2 English  2013-042013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
Medtronic® and SoftStart/Stop® are trademarks of Medtronic, Inc., registered in the US andother countries.Bluetooth® is a registered trademark of Bluetooth SIG, Inc.! USA FCC InformationThe following is communications regulation information on the Model 97725 Wireless ExternalNeurostimulator.FCC ID: LF597725This device complies with Part 15 of the FCC Rules. Operation is subject to the following twoconditions: (1) this device may not cause harmful interference, and (2) this device must acceptany 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 thisproduct.This device complies with Industry Canada license-exempt RSS standard(s). Operation issubject to the following two conditions: (1) this device may not cause interference, and (2) thisdevice must accept any interference, including interference that may cause undesiredoperation of the device. 2013-04  English 32013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
Table of contentsPurpose of the device 5Description 5Package contents 5Accessories 5Device specifications 5Declaration of Conformity 9Instructions for use 10Pairing the wireless external neurostimulator to a programmer or controller 10Using the wireless external neurostimulator during test stimulation 10Replacing the wireless external neurostimulator batteries 11Changing the batteries during test stimulation 11Changing the batteries before test stimulation 12Connecting the wireless external neurostimulator to the leads 14Connecting the wireless external neurostimulator to the 4-contact lead(s) 14Connecting the wireless external neurostimulator to the 8-contact lead(s) 16Preparing the wireless external neurostimulator for test stimulation 18Removing the wireless external neurostimulator after test stimulation 18Device care and storage 18Safety and technical checks 19 Refer to the indications sheet for indications and related information.Refer to the appropriate information for prescribers booklet for contraindications,warnings, precautions, adverse events summary, individualization of treatment,patient selection, use in specific populations, resterilization, and componentdisposal.Refer to System Eligibility, Battery Longevity, Specifications reference manual forneurostimulator selection, battery longevity calculations and specificneurostimulator specifications.! USA Refer to the clinical summary booklet for information on the clinical studyresults of the neurostimulation system and individualization of treatment.4 English  2013-042013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
Purpose of the deviceThe Medtronic Model 97725 Wireless External Neurostimulator (ENS) is used to evaluate aMedtronic Neurostimulation System during lead placement or test stimulation.DescriptionThe Medtronic Model 97725 Wireless External Neurostimulator is a disposable, sterile, single-use device equipped with Bluetooth wireless technology, and is part of a neurostimulationsystem.Package contents▪Wireless external neurostimulator with batteries inserted▪Spare AAA alkaline batteries (2)▪Product literature▪! USA Warranty cardAccessories▪Wireless external neurostimulator boot (packaged separately)Device specificationsThe Model 97725 Wireless External Neurostimulator (Figure 1 and Figure 2) is a multi-programmable device that delivers stimulation through 1 or more leads. The stimulationsettings are stored in programs to target pain areas. A program is a specific combination ofpulse width, rate, and intensity settings acting on a specific electrode combination (up to 16electrodes per program). Up to 4 pain areas can be targeted by programs. When stimulatingmore than one pain area, the pulses are delivered sequentially—first a pulse from oneprogram, then a pulse from the next program.Pulse width, intensity, cycling, and electrode polarity for each program within a group can havedifferent values. Rate, rate limits, pulse width limits, and intensity limits for each program withina group have the same values. 2013-04  English 52013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
Lead doorsENS buttonLead housingcompartment,black (electrodes 8-15) Lift tabsLead housingcompartment,white (electrodes 0-7)Figure 1. Model 97725 Wireless External Neurostimulator (doors closed).8 - contactlead grooveRetainer clip4 - contactlead grooveElectricalcontactsFigure 2. Model 97725 Wireless Exernal Neurostimulator (doors open). Table 1. Operating values for the Model 97725 Wireless External NeurostimulatorProgrammable parameter Operating values and rangesaNumber of defined groups 1-3 (optional)Number of programs per painarea1-3Number of programs 126 English  2013-042013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
 Table 1. Operating values for the Model 97725 Wireless External Neurostimulator(continued)Programmable parameter Operating values and rangesaNumber of pain areas 1-4Electrode configuration 2 to 16 electrodes as anode, cathode, or offMaximum intensity perelectrode0-25.5 mA (0.1-mA increment)Program intensity 0-100 mAIntensity – limits Enabled or disabled at maximum 25.5 mA per electrodePulse width 60 to 1000 µs (10-µs increment)Pulse width – limits Enabled or disabled at maximum 1000 µsRate 10 to 1200 Hzb (1-Hz increment between 10 and 30 Hz; 5-Hzincrement between 30 and 250 Hz; 10-Hz increment between250 and 500 Hz; 20-Hz increment between 500 and 1000 Hz;50-Hz increment between 1000 and 1200 Hz.)Rate ratio A fraction of the master rate (1/1, 1/2, 1/3, 1/4, 1/5)Rate - limits Enabled or disabled at maximum 1200 HzSoftStart/Stop Off, on: 1, 2, 4, or 8 second ramp durationCycling Off: 0.1 s to 30 min; on: 5 s-30 min (increment: 0.1 s from 0.1-1s, 1 s from 1 s-1 min, 1 min from 1-30 min)aInterlocks and out-of-regulation detection will prevent the use of some parameter combinations.bThe maximum rate available for the external neurostimulator is limited to 600 Hz when two pain areas aresimultaneously active, 400 Hz when three pain areas are simultaneously active, and to 300 Hz when fourpain areas are simultaneously active. Table 2. Physical characteristics of the Model 97725 Wireless ExternalNeurostimulatoraDescription ValueCapacityLeads 4 quadripolar; 2 octapolarElectrodes 32 electrodes, supporting 16 activeLength 79 mm (3.1 in)Height 79 mm (3.1 in) 2013-04  English 72013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
 Table 2. Physical characteristics of the Model 97725 Wireless ExternalNeurostimulatora (continued)Description ValueWidth 74 mm (2.9 in)Thickness 20 mm (0.8 in)Weight (with batteries) 71 g (2.5 oz)Battery life 7 days minimum for alkaline batteriesbPower source AAA alkaline batteries (2)Operating type ContinuousDegree of protection againstelectrical shockType BFAutomatic shut offcLead door(s) openTemperature limitationd-20 °C to 54 °C (-4 °F to 130 °F)Identification code NLJaAll measurements are approximate.bBattery life is based on a 7-day trial using two active programs, 20-90 second controller Bluetooth sessions,and a 180-minute clinician Bluetooth session. For program 1: impedance = 620 Ω, Amp = 10.6 mA, PW =330 µs, Rate = 60 Hz. For program 2: impedance = 560 Ω, Amp = 10.5 mA, PW = 330 µs, Rate = 60 Hz.cUse the clinician programmer or controller to turn on the external neurostimulator once the condition isresolved.dStore the external neurostimulator at room temperature. Table 3. Material of components in the Model 97725 Wireless External Neurostimulatorand boot accessory packagesComponent Material Material contactshuman tissueHousingBase Polycarbonate YesLead doors Polycarbonate YesHinge pin Stainless steel NoContacts Gold- and nickel-plated beryllium copper NoRetainer clip Thermoplastic elastomer (TPE) Yes8 English  2013-042013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
 Table 3. Material of components in the Model 97725 Wireless External Neurostimulatorand boot accessory packages (continued)Component Material Material contactshuman tissueExternal neurostimulatorbootBoot Silicone YesAdhesive Medical acrylic microporous-coatedadhesiveYesDeclaration of ConformityMedtronic declares that this product is in conformity with the essential requirements ofDirective 1999/5/EC on Radio and Telecommunications Terminal Equipment and Directive93/42/EEC on Medical Devices.For additional information, contact the appropriate Medtronic representative listed on theinside back cover of this manual. 2013-04  English 92013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
Instructions for useThe wireless external neurostimulator is used to evaluate lead placement and stimulationsettings.wWarning: This device was designed for single patient use only. Do not reuse, reprocess,or resterilize this product. Reuse, reprocessing, or resterilization may compromise thestructural integrity of the device and/or create a risk of contamination of the device, whichcould result in patient injury, illness, or death.#Caution: The device is not certified for use in the presence of a flammable anestheticmixture with air or with oxygen or nitrous oxide. The consequences of using the devicenear flammable atmospheres are unknown.#Caution: Do not modify this equipment. Modification of this equipment can result indamage to the device, causing the device to malfunction or become unusable.#Caution: Do not use the device in the proximity of equipment that generateselectromagnetic interference (EMI). EMI may cause a disruption in device function.Examples of common medical sources of EMI are magnetic resonance imaging (MRI)and lithotripsy. Powerful computer monitors, cell phones, x-ray equipment, and othermonitoring equipment may also generate EMI.Notes:▪Before placing the external neurostimulator into operation, ensure the externalneurostimulator has had time to equalize to the current temperature and environment.▪For more information on EMI and x-ray use with the external neurostimulator, refer to theInformation for Prescribers Booklet.▪Turn off and dispose of the external neurostimulator after defibrillation. For moreinformation on the effects of defibrillation on the neurostimulator, refer to the Informationfor Prescribers Booklet.Pairing the wireless external neurostimulator to a programmer orcontrollerFor instructions on pairing the external neurostimulator to the clinician programmer, refer tothe appropriate programming guide. For instructions on pairing the external neurostimulatorto the controller, refer to the appropriate controller patient guide.Using the wireless external neurostimulator during test stimulationWhen programming during test stimulation, keep the clinician programmer within 3 meters (10feet) of the external neurostimulator. The external neurostimulator does not attach to theprogrammer.Using the ENS buttonThe ENS button is used to place the external neurostimulator into discovery mode to establishcommunication with a clinician programmer or controller. It can also be used when you needto immediately turn off the external neurostimulator. The ENS button is not an on/off control.10 English  2013-042013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
You must use either the clinician programmer or controller to turn on the externalneurostimulator.▪Press and hold the ENS button for at least 3 seconds to turn off the externalneurostimulator.Understanding the LED light on the wireless external neurostimulatorWhen the external neurostimulator is turned on for the first time, the light-emitting diode (LED)shines continuously for a few seconds. When the LED begins to blink, the externalneurostimulator has completed initiation, has entered discovery mode, and can be paired toa clinician programmer or controller.Notes:▪The external neurostimulator will remain in discovery mode for 90 seconds, or until itsuccessfully pairs with a programmer or controller, at which point the LED will stopblinking and turn off.▪The LED blinks whenever the external neurostimulator is in discovery mode, or when itreceives data from a clinician programmer or controller.▪Refer to the appropriate programming guide or controller patient manual for moreinformation.Replacing the wireless external neurostimulator batteriesThe external neurostimulator includes batteries inserted in the device, which should last thelength of test stimulation (see Table 2 for more information on battery longevity). Replace theexternal neurostimulator batteries when the batteries are low or depleted. The battery level isshown on the clinician programmer and controller screens. For instructions on checking theexternal neurostimulator batteries, refer to the appropriate programming guide or the controllerpatient manual.#Cautions:▪When replacing batteries during test stimulation, save the programming settingsbefore removing the batteries. If programming settings are not saved, stimulationhistory may no longer be available, and the stimulation settings may not reflectrecent programming settings.▪Do not leave depleted batteries in the external neurostimulator. The batteries maycorrode and cause damage to the electronic components.Notes:▪Before inserting batteries, check for signs of battery leakage. If any residue is present,do not use.▪When replacing batteries outside the sterile field, use the spare alkaline batteriesprovided in the external neurostimulator package. The spare batteries are not sterile.Changing the batteries during test stimulation1. If the external neurostimulator is on, use the clinician programmer or controller to turnthe external neurostimulator off. 2013-04  English 112013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
2. Remove the tape or external neurostimulator boot from the external neurostimulator,keeping lead assembly and lead exit site secure. For instructions on removing theexternal neurostimulator boot from the external neurostimulator, refer to the boot'sinstructions for use.3. Remove the leads from the external neurostimulator.a. Lift the lift tabs to open the lead doors.b. Gently lift each lead from the electrical contacts in the lead groove.4. Proceed to step 2 in "Changing the batteries before test stimulation".Changing the batteries before test stimulation1. If the external neurostimulator is on, use the clinician programmer or controller to turnthe external neurostimulator off.2. Press back lightly on the latch of battery compartment cover, swing the cover open, thenremove the cover (Figure 3).Figure 3. Removing battery cover.3. Remove the depleted batteries, and insert new, Medtronic-supplied AAA alkalinebatteries. Correct battery polarity is indicated inside the battery compartment(Figure 4).12 English  2013-042013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
Note: For optimal performance, use the same AAA alkaline batteries as those suppliedby Medtronic.Figure 4. Inserting new batteries.4. Replace the battery compartment cover, then press the cover until it snaps into place(Figure 5).Figure 5. Replace battery cover.Notes:▪After the batteries are installed and the battery compartment cover is closed, theexternal neurostimulator may take up to 6 seconds for device initiation. Stimulationis not available until device initiation is complete.▪Dispose of depleted batteries according to local requirements.5. Place the leads in the external neurostimulator. Refer to "Connecting the wirelessexternal neurostimulator to the 4-contact lead(s)" on page 14 or "Connecting thewireless external neurostimulator to the 8-contact lead(s)" on page 16 for instructionsin placing the leads in the external neurostimulator. 2013-04  English 132013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
Note: If replacing batteries during test stimulation, ensure identical seating of the leadsinside the lead grooves.6. Use the programmer to turn stimulation on.7. Test lead insertion to confirm that the leads have been fully inserted into the lead grooves.For instructions on testing lead insertion, refer to the appropriate programming guide.8. Secure the external neurostimulator to the patient. Refer to "Preparing the wirelessexternal neurostimulator for test stimulation" on page 18 for instructions on securingthe external neurostimulator to the patient.Connecting the wireless external neurostimulator to the leadsThe external neurostimulator has two lead housing compartments that each fit two 4-contactleads and one 8-contact lead. The leads are placed in lead grooves, which are numbered 0-7on the white side and 8-15 on the black side (Figure 1). Leads are placed in both of the leadhousing compartments.▪If using four 4-contact leads, two are placed in each housing compartment.▪If using two 8-contact leads, one is placed in each housing compartment.▪If using two 4-contact leads and one 8-contact lead, the 4-contact leads are placed inone housing compartment and the 8-contact lead must be placed in the other.Notes:▪The 4-contact leads and the 8-contact leads enter the external neurostimulator in thesame direction.▪The procedure for connecting the external neurostimulator is the same for leads andextensions.Connecting the wireless external neurostimulator to the 4-contactlead(s)Check battery status before connecting the external neurostimulator to the leads. Refer to theappropriate programming guide for information on checking battery status.#Caution: Before connecting components, wipe off any body fluids and dry allconnections. Fluids in the connection may result in intermittent stimulation or loss ofstimulation.1. Wipe the lead contacts with dry sterile gauze.2. Lift the lift tab on the appropriate lead housing compartment to open the clear lead door(Figure 6a).3. Disconnect the long stylet handle from the 4-contact lead and withdraw the long styletfrom the 4-contact lead.4. Insert the short stylet into the 4-contact lead and connect the short stylet handle to the4-contact lead.5. Make sure the lead contacts and the electrical contacts inside the lead grooves are dryand clean.14 English  2013-042013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
6. Align the short stylet and proximal end of the lead against the inside end of a 4-contactlead groove of the connector (Figure 6a).Lead grooveElectrical contactsDoor latchLead groove numberingShort stylet handle abFigure 6. External neurostimulator with a 4-contact lead.7.Check that the lead contacts align with the electrical contacts inside the lead groove andthat the short stylet handle aligns with the stylet-shaped portion of the lead groove(Figure 7).Short stylet handleLead grooveElectrical contactsFigure 7. Align the lead contacts with the electrical contacts in the lead groove. 2013-04  English 152013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
Note: The lead and short stylet fit only one way into the external neurostimulator leadhousing.8. Press the lead and short stylet gently into the lead groove (Figure 6b). If an additional 4-contact lead is used, repeat step 1 and steps 3 to 8.9. Push the door(s) closed until the latch snaps firmly into place.Note: Do not force the doors closed; they should close easily. If they do not, disassemblethe components and repeat steps 2 to 9.10. Confirm correct seating by viewing the leads through the closed doors.11. Refer to the appropriate programming guide and lead manual to reestablishcommunication with the external neurostimulator and the clinician programmer, verifyproper connection, and identify optimal stimulation parameters.Connecting the wireless external neurostimulator to the 8-contactlead(s)Check battery status before connecting the external neurostimulator to the leads. Refer to theappropriate programming guide for information on checking battery status.#Caution: Before connecting components, wipe off any body fluids and dry allconnections. Fluids in the connection may result in intermittent stimulation or loss ofstimulation.1. Wipe the lead contacts with dry sterile gauze.2. Lift the lift tab on the appropriate lead housing compartment to open the clear lead door(Figure 8a).3. Make sure the lead contacts and the electrical contacts inside the lead grooves are dryand clean.4. While holding the 8-contact lead, disconnect the stylet handle from the lead (proximalend), and partially withdraw the stylet.Note: If connecting an extension or a lead without a stylet, proceed to step 5.5. Align the proximal end of the lead against the inside end of an 8-contact lead groove ofthe connector (Figure 8a).16 English  2013-042013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
Lead grooveElectrical contactsRetainer clipsDoor latchLead groove numberingStylet handle abFigure 8. External neurostimulator with an 8-contact lead with the stylet partiallywithdrawn.6. Check that the lead contacts align with the electrical contacts inside the lead groove(Figure 9).Lead grooveElectrical contactsStylet handleFigure 9. Align the lead contacts with the electrical contacts in the lead groove.Note: The lead fits only one way into the external neurostimulator lead housing.7.Press the lead gently into the lead groove and the retainer clip (Figure 8b). If anadditional 8-contact lead is used, repeat step 1 and steps 3 to 7.8.Push door(s) closed until the latch snaps firmly into place. 2013-04  English 172013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
Note: Do not force the doors closed; they should close easily. If they do not, disassemblethe components and repeat steps 2 to 8.9. Confirm correct seating by viewing the leads through the closed doors.10. Refer to the appropriate programming guide and lead manual to reestablishcommunication with the external neurostimulator and the clinician programmer, verifyproper connection, and identify optimal stimulation parameters.Preparing the wireless external neurostimulator for test stimulationCheck battery status and test lead insertion before attaching the external neurostimulator tothe patient. Refer to the appropriate programming guide for information on checking batterystatus and testing lead insertion.1. Place a gauze bandage on the skin where the lead and external neurostimulator will beplaced on the patient.Note: If using the wireless external neurostimulator boot, refer to the boot's instructionsfor use.2. Tape the lead and external neurostimulator separately to the skin.3. Tape the entire assembly to the skin, allowing for strain relief.Notes:▪Ensure that the ENS button faces away from the patient.▪Avoid placing bandaging over the ENS button in a way that obstructs it from use.4. Proceed with the trial evaluation.Removing the wireless external neurostimulator after teststimulation1. Verify that the external neurostimulator is off.2. Remove all tape from the lead and external neurostimulator.3. Lift the lift tabs to open the lead doors.4. Gently lift each lead from the electrical contacts in the lead groove.5. Dispose of the external neurostimulator according to environmental regulations.Device care and storage▪Keep new AAA alkaline batteries available. For optimal performance, use the samebatteries as those supplied by Medtronic.▪Use the clinician programmer or the controller to check the external neurostimulatorbattery level daily. For instructions on checking the external neurostimulator batteries,refer to the appropriate programming guide or the controller patient manual.▪Replace low or depleted batteries.▪Handle the device and system components with care. Do not drop, strike or step on thedevice or system components.▪Do not dismantle or tamper with the device.18 English  2013-042013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
▪Clean the outside of the device with a damp cloth when necessary. Mild householdcleaners will not damage the device or labels.▪Store the external neurostimulator at room temperature. Avoid extreme hot or coldtemperatures and direct sunlight.▪The device and system components are not waterproof. Do not allow moisture to getinside the device or system components.▪Dispose of depleted batteries and devices according to local requirements.Safety and technical checksPeriodic safety and technical checks or periodic maintenance of the external neurostimulatorare not required.The external neurostimulator contains no serviceable components. If the externalneurostimulator requires repair or is nonfunctional, send it to the appropriate address.USAMedtronic, Inc.Neurological DivisionMS N600PO Box 1250Minneapolis, MN 55440-9087Europe, Africa, Middle East, and Asia-Pacific countriesMedtronic EOCMedical Equipment Service EuropeEarl Bakkenstraat 106422 PJ HeerlenThe NetherlandsTel. 31-455664880Fax 31-455668028 2013-04  English 192013-04Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X
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 Czechia s.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 210-67-79-399Hungary: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) 580-7378SlovakiaMedtronic 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 08-568-585-01Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-20122013-04M946491A001 Rev X
Switzerland:Medtronic (Schweiz) AGTel. 031-868-0100Fax 031-868-0199The Netherlands:Medtronic B.V.Tel. (045)-566-8000Fax (045)-566-8668U.K.:Medtronic U.K. Ltd.Tel. 01923-212213Fax 01923-241004USA:Medtronic, Inc.Tel. (1763)-505-5000Fax (1763)-505-1000Toll-free: (1-800)-328-0810Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-2012M946491A001 Rev X2013-04
Manufacturer Medtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432-5604USAwww.medtronic.comTel. 1-763-505-5000Fax 1-763-505-1000Authorized RepresentativeEC REP in the European CommunityMedtronic B.V.Earl Bakkenstraat 106422 PJ HeerlenThe NetherlandsTel. 31-45-566-8000Fax 31-45-566-8668Europe/Africa/Middle EastHeadquartersMedtronic International Trading SàrlRoute du Molliau 31Case Postale 84CH-1131 TolochenazSwitzerlandwww.medtronic.euTel. 41-21-802-7000Fax 41-21-802-7900Asia-PacificMedtronic International Ltd.Suite 1106-11, 11/F, Tower 1, The Gateway25 Canton Road, TsimshatsuiKowloonHong KongTel. 852-2891-4068Fax 852-2591-0313Contacts for specific countries are listed inside this cover.*M946491A001*© Medtronic, Inc. 2013All Rights ReservedM946491A001Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic  ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 05-31-20122013-04M946491A001 Rev X

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