Medtronic 97716 Implantable Neurostimulator User Manual

Medtronic, Inc. Implantable Neurostimulator

User Manual

Intellis™ 97715Rechargeable neurostimulatorImplant manual! USARx only2012Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A0012012-06
Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A0012012-06
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 AIMD Directive 90/385/EEC (NB 0123) andR&TTE Directive 1999/5/EC.WarningConsult instructions for useDo not reuseSTERILIZE2Do not resterilizeDate of manufactureManufacturerOpen hereUse bySerial numberSTERILE EOSterilized using ethylene oxideEC REPAuthorized Representative in the European Community! USAFor USA audiences onlyXXX °FXX °C-XX °F-XX °CTemperature limitation97715 2012-06 English 12012-06Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A001
Medtronic® and SoftStart/Stop® are trademarks of Medtronic, Inc., registered in the U.S. andother countries.AdaptiveStim™ and Intellis™ are trademarks of Medtronic, Inc.2 English 97715 2012-062012-06Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A001
Table of contentsDescription 5Package contents 5Patient identification card 5Device specifications 5Declaration of conformity 8Instructions for use 9Charging the neurostimulator battery 9Verifying neurostimulator operation 9Connecting the extension or lead to the neurostimulator 10Implanting the neurostimulator 11Checking system integrity 12Completing the implant procedure 12Refer 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. Refer to the clinical summary booklet for information on the clinical studyresults of the neurostimulation system and individualization of treatment.97715 2012-06 English 32012-06Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A001
4 English 97715 2012-062012-06Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A001
DescriptionThe Medtronic Intellis Model 97715 Neurostimulator is part of a neurostimulation system forpain therapy.Package contents▪Neurostimulator▪Torque wrench▪Pocket sizer▪Bore plugs (2)▪Product literature▪Registration form▪Patient identification card▪Warranty cardPatient identification cardA patient identification card is packaged with this device. Advise the patient to carry theidentification card at all times.! USA The patient identification card packaged with the device is temporary; a permanent cardwill be mailed to the patient when Medtronic receives the registration form.The implant registration form registers the device warranties and creates a record of the devicein Medtronic’s implant data system.Device specificationsThe neurostimulator is a multi-programmable, rechargeable device that delivers stimulationthrough 1 or more leads. The stimulation settings are stored in programs to target pain areas.A program is a specific combination of pulse width, rate, and intensity settings acting on aspecific electrode combination (up to 16 electrodes per program). Up to 4 pain areas can betargeted by programs. When stimulating more than one pain area, the pulses are deliveredsequentially—first a pulse from one program, then a pulse from the next program.Date, pulse width, intensity, cycling, and electrode polarity for each program within the groupcan have different values. Rate, rate limits, pulse width and intensity limits, and ramping foreach program within the group have the same values.97715 2012-06 English 52012-06Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A001
Table 1. Operating values for the Intellis Model 97715 NeurostimulatorProgrammable parameter Operating values and rangesaNumber of defined groups 1-3 (optional)Number of programs per painarea1-3Number of programs 12Number of pain areas 1-4Electrode configuration 2-16 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 of 25.5 mA per electrodePulse width 60-1000 µs (10-µs increment)Pulse width – limitsbEnabled or disabled at maximum of 1000 HzMaster ratea10-1200 Hz (increment: 1 Hz from 10-30 Hz, 5 Hz from30-250 Hz, 10 Hz from 250-500 Hz, 20 Hz from 500-1000 Hz,50 Hz from 1000-1200 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 of 1200)aSoftStart/Stop Off, On: 1, 2, 4, or 8 second ramp durationCyclingcOff, On: 0.1 s-30 min (resolution: 0.1 s from 0.1-1 s, 1 s from 1s-1 min, 1 min from 1-30 min)AdaptiveStim Off, On: 7 positionsaRate availability depends on how many pain areas are defined. For example, the maximum rate available inone defined pain area is 1200 Hz. The maximum rate available if two pain areas are defined is 600 Hz ineach of those two pain areas.bPulse width limits are not available when AdaptiveStim is enabled.cCycling is not available for pain areas with AdaptiveStim enabled.6 English 97715 2012-062012-06Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A001
Table 2. Physical characteristics of the Intellis Model 97715 NeurostimulatoraDescription ValueConnector type Octapolar, in-line 2.8-mm (0.110-in) spacingHeight 57.0 mm (2.1 in)Width 47.3 mm (1.9 in)Thicknesscase 6.3 mm (0.2 in)connector 8.9 mm (0.4 in)Weight 29.9 g (1.1 oz)Volume 13.7 cm3Battery life 9 years before ERIPower source Lithium ion rechargeable batteryStorage temperature –18 °C to +52 °C (0 °F to +126 °F)Serial number model designatorbNMERadiopaque identification (ID) code NMEaAll measurements are approximate.bThe serial number is the model designator followed by a number. The clinician programmer displays theentire serial number beginning with the model designator.97715 2012-06 English 72012-06Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A001
Table 3. Material of components in the Intellis Model 97715 packageComponents Material Material contacts human tissueNeurostimulatorCase Titanium YesConnector block Titanium, polysulfone, siliconerubber, silicone medical adhesiveYesGrommets, seals Silicone rubber YesSetscrews Titanium alloy YesAdhesive Silicone medical adhesive YesPocket sizer Polypropylene YesBore plug Silicone rubber; stainless steel YesTorque wrenchHandle Polyetherimide YesShaft Stainless steel YesDeclaration 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 90/385/EECon Active Implantable Medical Devices.For additional information, contact the appropriate Medtronic representative listed on the insideback cover of this manual.8 English 97715 2012-062012-06Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A001
Instructions for useImplanting physicians should be experienced in epidural-access procedures and should bethoroughly familiar with all product labeling.wWarning: DO NOT use the recharger on an unhealed wound. The recharging systemis not sterile, and contact with the wound can cause an infection.#Caution: If the neurostimulator is not being used for an extended period of time,recommend that your patient charge the neurostimulator at least once per year. If thebattery is discharged, stimulation will stop and the neurostimulator may notcommunicate with the controller.#Caution: Advise patients to charge the neurostimulator when a low battery message isdisplayed on the controller in order to maintain uninterrupted therapy from theneurostimulator. If the battery is discharged, stimulation will stop and theneurostimulator may not communicate with the controller.Note: The patient will be able to use the controller and recharger to charge a dischargedbattery without causing damage to the battery or the neurostimulator.#Cautions:▪When using sharp instruments near the neurostimulator, be extremely careful toavoid nicking or damaging the case, the insulation, or the connector block.Damaging the neurostimulator may require surgical replacement.▪Do not use saline or other ionic fluids at connections, which could result in a shortcircuit.Charging the neurostimulator batteryCheck the battery level of the neurostimulator before opening the package, and recharge theneurostimulator if the battery is low. For charging instructions, refer to the recharging systemuser manual. If the patient will be sent home with stimulation on, charge the neurostimulatorin the package before implant.Verifying neurostimulator operationBefore opening the sterile neurostimulator package, verify that the neurostimulator is operableby using the clinician programmer to interrogate the neurostimulator and read theneurostimulator battery charge level. (Refer to the programming guide for instructions on howto read the battery charge level.)#Caution: Do not implant a neurostimulator if it was dropped onto a hard surface from aheight of 30 cm (12 in) or more, because the neurostimulator may be damaged and failto operate properly.Note: The neurostimulator pocket may be flushed with an antibiotic solution; do not submergethe neurostimulator in fluid.97715 2012-06 English 92012-06Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A001
Connecting the extension or lead to the neurostimulator#Caution: Before connecting components, wipe off any body fluids and dry allconnections. Fluids in the connection may result in stimulation at the connection site,intermittent stimulation, or loss of stimulation.1. Wipe the extension or lead connector pins with sterile gauze. If necessary, use sterile(United States Pharmacopeia [USP]) water or a nonionic antibiotic solution.2. Make sure the connector block receptacles are dry and clean.3. Insert the appropriate extension or lead connector pins into the appropriateneurostimulator socket until they are seated fully within the connector block (Figure 1).Notes:▪During insertion, some resistance is typical.▪To retract the setscrews, insert the torque wrench into the self-sealing grommet androtate the setscrews counterclockwise; however, do not remove the setscrews fromthe connector block.#Caution: Do not insert the extension or lead connector into the connector block ifthe setscrews are not sufficiently retracted. If the setscrews are not retracted, thesetscrews may damage the extension or lead and the extension or lead will not beseated fully into the connector block.Socket II (Electrodes 8-15)Extension or Lead 2Extension or Lead 1Socket I (Electrodes 0-7)Figure 1. Insert the extension or lead connector pins fully into the neurostimulator.10 English 97715 2012-062012-06Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A001
Note: Insert a connector plug (from an accessory kit) into any unused neurostimulatorsocket.4. For each extension, lead, or plug, fully insert the torque wrench (packaged with therechargeable neurostimulation system) into each self-sealing grommet of the connectorblock and tighten each setscrew (Figure 2).#Cautions:▪Be sure the torque wrench is fully inserted into the self-sealing grommet. If thetorque wrench is not fully inserted, the setscrew may be damaged, resultingin intermittent or loss of stimulation.▪Before tightening setscrews, ensure that the extension or lead connector pinsare inserted into the connector block to prevent damaging the lead orextension.▪Verify that each leaf of the self-sealing grommet is closed after the torquewrench is withdrawn. If fluid leaks through a grommet seal that is not fullyclosed, the patient may experience shocking, burning, or irritation at theneurostimulator implant location, or intermittent stimulation, or loss ofstimulation.Figure 2. Tightening the setscrews in the self-sealing grommet.Implanting the neurostimulator1. Place the neurostimulator into the subcutaneous pocket using the pocket sizer if desiredand ensure that the extension or lead is not bent sharply. The neurostimulator can beimplanted and charged with either side facing outward. for optimal recharging, place theneurostimulator within 1-2 cm (0.8 in.) of the skin surface.#Cautions:▪Ensure that the neurostimulator is placed no deeper than 3 cm (1.2 in) belowthe skin and is parallel to the skin. If the neurostimulator is too deep or is notparallel to the skin, recharge may be inefficient or unsuccessful.97715 2012-06 English 112012-06Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A001
▪Do not coil excess extension in front of the neurostimulator. Wrap excessextension or leads around the perimeter (Figure 3) or behind theneurostimulator to help minimize potential damage during neurostimulatorreplacement surgery, help minimize potential kinking of the extension or lead,and minimize interference with telemetry and recharge operation.Figure 3. Wrap excess extension around the perimeter of the neurostimulator.2. Use the suture holes in the connector block to secure the neurostimulator to the musclefascia with nonabsorbable silk.Note: Secure the neurostimulator in the pocket to minimize movement or migration ofthe neurostimulator.Checking system integrityThe connections of the extensions and leads to the neurostimulator can be checked using theclinician programmer. Refer to the programming guide for detailed programminginstructions.wWarning: To use the nonsterile programmer system components in a sterile field, placea sterile barrier between the patient and system components to prevent infection. Do notsterilize any components of the programmer system. Sterilization may damage thecomponents.1. To ensure proper connection of each extension or lead to the neurostimulator, use theclinician programmer to perform the lead insertion check.2. If the lead insertion check results are not acceptable, refer to "Connecting the extensionor lead to the neurostimulator".Completing the implant procedure1. Close and dress all incisions.2. Turn off stimulation before sending your patient home.3. Ensure that a patient control device is given to the patient.12 English 97715 2012-062012-06Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A001
4. Complete the device tracking and patient registration paperwork and return thedocuments to Medtronic.97715 2012-06 English 132012-06Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A001
Contacts:Asia:Medtronic International Ltd.Tel. 02891-4068Fax 02591-0313Medtronic 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. 3-6430-2016Fax 3-6430-7110Latin 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 EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-20112012-06M946871A001
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 EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-2011M946871A0012012-06
ManufacturerMedtronic, Inc.710 Medtronic Parkway,Minneapolis, MN 55432-5604,USA.www.medtronic.comTel. +1-763-505-5000Fax +1-763-505-1000Authorized RepresentativeEC REPin the European CommunityMedtronic B.V.Earl Bakkenstraat 10,6422 PJ Heerlen,The NetherlandsTel. +31-45-566-8000Fax +31-45-566-8668Europe/Africa/Middle EastHeadquartersMedtronic International Trading SàrlRoute du Molliau 31,Case Postale 84CH-1131 Tolochenaz,Switzerlandwww.medtronic.euTel. +41-21-802-7000Fax +41-21-802-7900Asia-PacificMedtronic International Ltd.Suite 1602 16/F, Manulife Plaza,The Lee Gardens, 33 Hysan Avenue,Causeway Bay,Hong KongTel. +852-2891-4068Fax +852-2591-0313Contacts for specific countries are listed inside this cover.*M946871A001*© Medtronic, Inc. 2012All Rights ReservedM946871A001Filename Date TimeUC200xxxxxx EN4.6 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialImplantManual.xsl - IPGTemplate.fmTemplate version: 08-02-20112012-06M946871A001

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