Medtronic 3531 Verify ENS (external neurostimulator) User Manual

Medtronic, Inc. Verify ENS (external neurostimulator)

User Manual

VERIFYTM EXTERNALNEUROSTIMULATOR3531User manual! USARx onlyFilename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X2013-03
Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X2013-03
Explanation of symbols on product or package labelingRefer to the appropriate product for symbols that apply.Conformité Européenne (European Conformity). This symbol means that thedevice fully complies with MDD 93/42/EEC (NB 0123) and R&TTE Directive1999/5/EC.System meets the applicable Canadian (CAN/CSA-C22.2 No. 60601-1)electrical safety standard requirements.Do not reuseConsult instructions for useSerial numberManufacturerEC REPAuthorized representative in the European communityIEC60601-1/EN60601-1, Type BF equipmentNon-ionizing electromagnetic radiationXXX °FXX °C-XX °F-XX °CTemperature limitationFor USA audiences onlyDo not dispose of this product in the unsorted municipal waste stream. Disposeof this product according to local regulations. See http://recycling.medtronic.comfor instructions on proper disposal of this product.Chinese Standard (SJ/T11364-2006) Logo: Electronic Information ProductsPollution Control Symbol. (The date in this logo means the environmentalprotection use period of the product.) 2013-03 English 12013-03Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X
Medtronic® is a trademark of Medtronic, Inc., registered in the U.S. and other countries.VerifyTM is a trademark of Medtronic, Inc.Bluetooth® is a registered trademark of Bluetooth SIG, Inc.! USA FCC InformationThe following is communications regulation information on the Model 3531 ExternalNeurostimulator.FCC ID: LF53531This 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.2 English 2013-032013-03Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X
Table of contentsPurpose of the device 5Description 5Package contents 5Device specifications 5Declaration of Conformity 8Instructions for use 9Pairing the external neurostimulator to the controller 9Using the external neurostimulator during test stimulation 9Replacing the external neurostimulator batteries 10Using the external neurostimulator boot 12Using the external neurostimulator belt 13Device care and storage 15Safety and technical checks 15Refer 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 the Test stimulation lead implant manual packaged with the test stimulationlead for test stimulation-specific contraindications, warnings, precautions, adverseevents summary, individualization of treatment, patient selection, use in specificpopulations, resterilization, and component disposal.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. 2013-03 English 32013-03Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X
4 English 2013-032013-03Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X
Purpose of the deviceThe Medtronic Model 3531 Verify External Neurostimulator (ENS) is used to evaluate aMedtronic Sacral Neuromodulation (SNM) System during lead placement or teststimulation.DescriptionThe Medtronic Model 3531 External Neurostimulator is a disposable, single-use deviceequipped with Bluetooth wireless technology, and is part of a sacral neuromodulationsystem.Package contents▪External neurostimulator▪External neurostimulator boot▪AAAA alkaline batteries (4)▪Product literature▪! USA Warranty cardDevice specificationsThe external neurostimulator (Figure 1) is a programmable device that delivers stimulationthrough one or more leads (delivered through one lead at a time). The stimulation settings arestored in programs. A program is a specific combination of pulse width, rate, and amplitudesettings acting on a specific electrode combination. 2013-03 English 52013-03Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X
Light-emitting diode (LED) ENS buttonOutput jackFigure 1. Model 3531 External Neurostimulator.Table 1. Operating values for the Model 3531 External NeurostimulatoraProgrammable parameter Operating values and rangesbNumber of programs 1 to 3Electrode configuration 1 to 4 electrodes as anode, cathode, or offAmplitude 0 to 12.5 mA with 0.1-mA resolutionAmplitude – upper patientlimitProgrammed value to 12.5 mA (same resolution as amplitude)Amplitude – lower patientlimit0 mA to the programmed value (same resolution as amplitude)Pulse width 60 to 450 µs (10-µs resolution)Rate 3 to 130 Hz (1-Hz resolution between 3 and 30 Hz; 5-Hzresolution between 30 and 130 Hz)aSelection of parameters and values is limited by the controller with regards to appropriate applications,therapies, and devices.bOut-of-regulation detection may prevent the use of some parameter combinations.Table 2. Physical characteristics of the Model 3531 External NeurostimulatoraDescription ValueLength 51 mm (2.0 in)Length, including cable connector 58 mm (2.3 in)6 English 2013-032013-03Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X
Table 2. Physical characteristics of the Model 3531 External Neurostimulatora(continued)Description ValueWidth 43 mm (1.7 in)Thickness 15 mm (0.6 in)Weight (with batteries) 53.9 g (1.9 oz)Output jack 21 pinIdentification code NLMaAll measurements are approximate.Table 3. Electrical and physical characteristics for the Model 3531 ExternalNeurostimulatorDescription ValuePower source AAAA alkaline batteries (2)Battery life 14 days minimum for alkaline batteriesaOperating type ContinuousDegree of protection against electricalshockType BFDegree of protection against fluid ingress IP24bCase material Polycarbonate/ABS blend plastic resinAutomatic shut offcConnector cable disconnectedaBattery life is based on 24-hour per day stimulation using 1 program: impedance = 1200 Ω,amplitude = 4.2 mA, pulse width = 210 µs, rate = 14 Hz, and multiple communications between thecontroller and the external neurostimulator.bThe ENS device, with cable fully inserted and battery door side protected either by the device beingbandaged directly to the skin or by having the device in the boot or belt, meets the IP24 classificationfor particulate and water exposure resistance. IP classification is IPN1N2, where: N1 is 2 =protection of equipment against a solid foreign objects ≥ 12.5 mm diameter and N2 is 4 = protectionof equipment against ingress of water with harmful effects of splashing.cUse the controller to turn the external neurostimulator on once the condition is resolved. 2013-03 English 72013-03Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X
Table 4. Storage, shipping, and operating conditions for theModel 3531 External NeurostimulatorParameter Storage Shipping OperatingMinimum temperature Roomtemperature-35 °C (-31 °F) 9 °C (49 °F)Maximum temperature Roomtemperature57 °C (135 °F) 43 °C (110 °F)Maximum humidity — 95% (non-condensing)a95% (non-condensing)bMinimum atmosphericpressure——50 kPaMaximum atmosphericpressure— — 106 kPaaTested at 30 °C (86 °F). Not tested at the maximum temperature.bTested at 35 °C (95 °F). Not tested at the maximum temperature.Declaration of ConformityMedtronic declares that this product is in conformity with the essential requirements of Directive1999/5/EC on Radio and Telecommunications Terminal Equipment and Directive 93/42/EECon Medical Devices.For additional information, contact the appropriate Medtronic representative listed on the insideback cover of this manual.8 English 2013-032013-03Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X
Instructions for useThe external neurostimulator is used to evaluate lead placement and stimulation settings.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.Note: Turn off and dispose of the external neurostimulator after defibrillation. For moreinformation on the effects of defibrillation on the neurostimulator, refer to the Information forPrescribers Booklet.Pairing the external neurostimulator to the controllerFor instructions on pairing the external neurostimulator to the controller, refer to theappropriate controller programming guide.Using the external neurostimulator during test stimulationWhen programming during test stimulation, keep the controller within 3 meters (10 feet) of theexternal neurostimulator. The external neurostimulator does not attach to the controller.Using the ENS buttonThe ENS button is used to place the external neurostimulator into discovery mode to establishcommunication with a controller. It can also be used when you need to immediately turn offthe external neurostimulator. You must use the controller to turn on the externalneurostimulator. The ENS button is not an on/off control.Press and hold the ENS button for at least three seconds to turn off the externalneurostimulator or to place the external neurostimulator into discovery mode.Understanding the LED on the external neurostimulatorOnce batteries are inserted into the external neurostimulator, the external neurostimulatorturns on, and the light-emitting diode (LED) shines continuously for a few seconds. When theLED begins to blink, the external neurostimulator has completed initiation, has entereddiscovery mode, and can be paired to a controller. 2013-03 English 92013-03Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X
Notes:▪The external neurostimulator will remain in discovery mode for 90 seconds, or until itsuccessfully pairs with a controller, at which point the LED will stop blinking and turnoff.▪The LED blinks whenever the external neurostimulator is in discovery mode, or when itreceives data from a controller.▪Refer to the appropriate programming guide for more information on using thecontroller.Replacing the external neurostimulator batteriesFor instructions on checking the external neurostimulator batteries using the controller, referto the appropriate controller programming guide.#Caution: Do not leave depleted batteries in the external neurostimulator. The batteriesmay corrode and cause damage to the electronic components.#Caution: If the device will not be used for several weeks, remove the batteries from thedevice. A battery left in the device may corrode, causing damage to the electroniccomponents.Notes:▪Before inserting batteries, check for signs of battery leakage. If any residue is present,do not use.▪Stimulation settings may not reflect programming changes that were made prior toreplacing the batteries.1. If the external neurostimulator is on, use the programmer to turn the externalneurostimulator off.2. If the connector cable is attached to the external neurostimulator, disconnect thecable.3. If the external neurostimulator is in the external neurostimulator belt or boot, remove theexternal neurostimulator from the belt or boot.4. Press down lightly on the battery compartment cover, slide the cover outward, thenremove the cover (Figure 2).10 English 2013-032013-03Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X
Figure 2. Removing battery cover.5. Remove the depleted batteries, and insert new batteries. Correct battery polarity isindicated inside the battery compartment (Figure 3).Note: For optimal performance, use the same AAAA alkaline batteries as those suppliedby Medtronic.Figure 3. Inserting new batteries.6. Replace the battery compartment cover, then slide the cover inward until it snaps intoplace (Figure 4). 2013-03 English 112013-03Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X
Figure 4. Replacing 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.7. Use the controller to turn stimulation on. For instructions on using the controller toprogram the external neurostimulator, refer to the Medtronic Clinician ProgrammingGuide packaged with the controller.Using the external neurostimulator bootThe external neurostimulator boot is a single-use accessory. The external neurostimulator bootis attached to an adhesive pad, which can be used to adhere the external neurostimulator tothe patient's body.Note: Schedule a visit during the test stimulation phase to replace the initial boot with a newboot.1. Ensure that no cable is attached to the external neurostimulator. The externalneurostimulator can not be inserted into the boot with a cable attached.2. Insert the external neurostimulator into the boot (Figure 5).12 English 2013-032013-03Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X
Figure 5. Inserting external neurostimulator into boot.3. Clean the patient's skin, if necessary, at the location where the external neurostimulatorboot is to be placed.4. Peel off the adhesive backing of the adhesive pad and apply the externalneurostimulator boot to the patient's skin. Press firmly to ensure complete contact andadhesion.Notes:▪If adhesive is dry or does adhere to the patient's skin, discard the boot and use adifferent boot.▪The external neurostimulator belt cannot be used with the external neurostimulatorboot.Using the external neurostimulator beltThe external neurostimulator belt is a single-use device that can be used to hold the externalneurostimulator near the patient's body.1. Insert the external neurostimulator, with cable attached, into the pouch on the externalneurostimulator belt and snap the pouch closed (Figure 6). 2013-03 English 132013-03Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X
Figure 6. Inserting external neurostimulator into belt.Note: Leave enough slack in the cable to allow the patient to adjust or move the belt asneeded without causing additional strain on the connections.2. Coil and place any excess cable length into the pouch of the external neurostimulatorbelt.3. Fasten the external neurostimulator belt around the patient’s waist.Note: The belt can be adjusted for patient comfort and fit.14 English 2013-032013-03Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 Rev X
Device care and storage▪Keep new batteries available. For optimal performance, use the same AAAA alkalinebatteries as those supplied by Medtronic.▪Use the controller to check the external neurostimulator battery level daily. Forinstruction on using the controller, refer to the Medtronic Clinician Programming Guidepackaged with the controller.▪Replace low or depleted batteries.▪Handle the device and system components with care. Do not drop, strike or step on thedevice.▪Do not dismantle or tamper with the device or system components.▪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. With the patient cable connected, the externalneurostimulator is water-resistant, but is not waterproof. Sponge baths areacceptable.▪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 2013-03 English 152013-03Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-2011M943581A001 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: 12-13-20112013-03M943581A001 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: 12-13-2011M943581A001 Rev X2013-03
Manufacturer Medtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432-5604USAwww.medtronic.comTel. +1-763-505-5000Fax +1-763-505-1000Authorized Representative EC REPin 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 16/F, Tower 1, The Gateway25 Canton Road, TsimshatsuiKowloonHong KongTel. +852-2919-1362Fax +852-2907-3998Contacts for specific countries are listed inside this cover.*M943581A001*© Medtronic, Inc. 2013All Rights ReservedM943581A001Filename Date TimeUC200xxxxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 12-13-20112013-03M943581A001 Rev X

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