Medtronic 97716 Implantable Neurostimulator User Manual
Medtronic, Inc. Implantable Neurostimulator
User Manual
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| Document ID | 3393408 |
| Application ID | gddYc5GQYUqXURd3nrrXhg== |
| Document Description | User Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 47.05kB (588066 bits) |
| Date Submitted | 2017-05-16 00:00:00 |
| Date Available | 2017-05-16 00:00:00 |
| Creation Date | 2011-10-18 08:27:50 |
| Producing Software | Acrobat Distiller 10.0.0 (Windows) |
| Document Lastmod | 2011-10-18 08:28:48 |
| Document Title | User Manual |
| Document Creator | XSL Formatter V4.2 MR5 (4,2,2008,0229) for Windows |
| Document Author: | huntet2 |
Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Intellis™ Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 97715 Rechargeable neurostimulator Implant manual ! USA M946871A001 Rx only 2012 2012-06 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) M946871A001 Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 2012-06 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 Explanation of symbols on product or package labeling Refer to the appropriate product for symbols that apply. Conformité Européenne (European Conformity). This symbol means that the device fully complies with AIMD Directive 90/385/EEC (NB 0123) and R&TTE Directive 1999/5/EC. Warning Consult instructions for use Do not reuse STERILIZE Do not resterilize Date of manufacture Manufacturer Open here Use by Serial number STERILE EO EC REP ! USA -XX °C -XX °F XX °C XXX °F Sterilized using ethylene oxide Authorized Representative in the European Community For USA audiences only Temperature limitation 97715 2012-06 M946871A001 English 2012-06 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 Medtronic® and SoftStart/Stop® are trademarks of Medtronic, Inc., registered in the U.S. and other countries. AdaptiveStim™ and Intellis™ are trademarks of Medtronic, Inc. English 2012-06 97715 2012-06 M946871A001 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 Table of contents Description 5 Package contents 5 Patient identification card 5 Device specifications 5 Declaration of conformity 8 Instructions for use 9 Charging the neurostimulator battery 9 Verifying neurostimulator operation 9 Connecting the extension or lead to the neurostimulator 10 Implanting the neurostimulator 11 Checking system integrity 12 Completing the implant procedure 12 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 component disposal. Refer to System Eligibility, Battery Longevity, Specifications reference manual for neurostimulator selection, battery longevity calculations and specific neurostimulator specifications. Refer to the clinical summary booklet for information on the clinical study results of the neurostimulation system and individualization of treatment. 97715 2012-06 M946871A001 English 2012-06 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) English 2012-06 Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 97715 2012-06 M946871A001 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 Description The Medtronic Intellis Model 97715 Neurostimulator is part of a neurostimulation system for pain therapy. Package contents ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ Neurostimulator Torque wrench Pocket sizer Bore plugs (2) Product literature Registration form Patient identification card Warranty card Patient identification card A patient identification card is packaged with this device. Advise the patient to carry the identification card at all times. ! USA The patient identification card packaged with the device is temporary; a permanent card will 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 device in Medtronic’s implant data system. Device specifications The neurostimulator is a multi-programmable, rechargeable device that delivers stimulation through 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 a specific electrode combination (up to 16 electrodes per program). Up to 4 pain areas can be targeted by programs. When stimulating more than one pain area, the pulses are delivered sequentially—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 group can have different values. Rate, rate limits, pulse width and intensity limits, and ramping for each program within the group have the same values. 97715 2012-06 M946871A001 English 2012-06 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 Table 1. Operating values for the Intellis Model 97715 Neurostimulator Programmable parameter Operating values and rangesa Number of defined groups 1-3 (optional) Number of programs per pain 1-3 area Number of programs 12 Number of pain areas 1-4 Electrode configuration 2-16 electrodes as anode, cathode, or Off Maximum intensity per electrode 0-25.5 mA (0.1 mA increment) Program intensity 0-100 mA Intensity – limits Enabled or disabled at maximum of 25.5 mA per electrode Pulse width 60-1000 µs (10-µs increment) Pulse width – limitsb Enabled or disabled at maximum of 1000 Hz Master ratea 10-1200 Hz (increment: 1 Hz from 10-30 Hz, 5 Hz from 30-250 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)a SoftStart/Stop Off, On: 1, 2, 4, or 8 second ramp duration Cyclingc Off, On: 0.1 s-30 min (resolution: 0.1 s from 0.1-1 s, 1 s from 1 s-1 min, 1 min from 1-30 min) AdaptiveStim Off, On: 7 positions Rate availability depends on how many pain areas are defined. For example, the maximum rate available in one defined pain area is 1200 Hz. The maximum rate available if two pain areas are defined is 600 Hz in each of those two pain areas. Pulse width limits are not available when AdaptiveStim is enabled. Cycling is not available for pain areas with AdaptiveStim enabled. English 2012-06 97715 2012-06 M946871A001 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 Table 2. Physical characteristics of the Intellis Model 97715 Neurostimulatora Description Value Connector type Octapolar, in-line 2.8-mm (0.110-in) spacing Height 57.0 mm (2.1 in) Width 47.3 mm (1.9 in) Thickness case connector 6.3 mm (0.2 in) 8.9 mm (0.4 in) Weight 29.9 g (1.1 oz) Volume 13.7 cm3 Battery life 9 years before ERI Power source Lithium ion rechargeable battery Storage temperature –18 °C to +52 °C (0 °F to +126 °F) Serial number model designatorb NME Radiopaque identification (ID) code NME All measurements are approximate. The serial number is the model designator followed by a number. The clinician programmer displays the entire serial number beginning with the model designator. 97715 2012-06 M946871A001 English 2012-06 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 Table 3. Material of components in the Intellis Model 97715 package Components Material Material contacts human tissue Case Titanium Yes Connector block Titanium, polysulfone, silicone Yes rubber, silicone medical adhesive Neurostimulator Grommets, seals Silicone rubber Setscrews Titanium alloy Yes Yes Adhesive Silicone medical adhesive Yes Pocket sizer Polypropylene Yes Bore plug Silicone rubber; stainless steel Yes Handle Polyetherimide Yes Shaft Stainless steel Yes Torque wrench Declaration of conformity Medtronic declares that this product is in conformity with the essential requirements of Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment and Directive 90/385/EEC on Active Implantable Medical Devices. For additional information, contact the appropriate Medtronic representative listed on the inside back cover of this manual. English 2012-06 97715 2012-06 M946871A001 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 Instructions for use Implanting physicians should be experienced in epidural-access procedures and should be thoroughly familiar with all product labeling. w Warning: DO NOT use the recharger on an unhealed wound. The recharging system is 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 the battery is discharged, stimulation will stop and the neurostimulator may not communicate with the controller. # Caution: Advise patients to charge the neurostimulator when a low battery message is displayed on the controller in order to maintain uninterrupted therapy from the neurostimulator. If the battery is discharged, stimulation will stop and the neurostimulator may not communicate with the controller. Note: The patient will be able to use the controller and recharger to charge a discharged battery without causing damage to the battery or the neurostimulator. # Cautions: ▪ When using sharp instruments near the neurostimulator, be extremely careful to avoid 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 short circuit. Charging the neurostimulator battery Check the battery level of the neurostimulator before opening the package, and recharge the neurostimulator if the battery is low. For charging instructions, refer to the recharging system user manual. If the patient will be sent home with stimulation on, charge the neurostimulator in the package before implant. Verifying neurostimulator operation Before opening the sterile neurostimulator package, verify that the neurostimulator is operable by using the clinician programmer to interrogate the neurostimulator and read the neurostimulator battery charge level. (Refer to the programming guide for instructions on how to read the battery charge level.) # Caution: Do not implant a neurostimulator if it was dropped onto a hard surface from a height of 30 cm (12 in) or more, because the neurostimulator may be damaged and fail to operate properly. Note: The neurostimulator pocket may be flushed with an antibiotic solution; do not submerge the neurostimulator in fluid. 97715 2012-06 M946871A001 English 2012-06 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 Connecting the extension or lead to the neurostimulator # Caution: Before connecting components, wipe off any body fluids and dry all connections. 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 appropriate neurostimulator 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 and rotate the setscrews counterclockwise; however, do not remove the setscrews from the connector block. # Caution: Do not insert the extension or lead connector into the connector block if the setscrews are not sufficiently retracted. If the setscrews are not retracted, the setscrews may damage the extension or lead and the extension or lead will not be seated fully into the connector block. Socket I (Electrodes 0-7) Socket II (Electrodes 8-15) Extension or Lead 1 Extension or Lead 2 Figure 1. Insert the extension or lead connector pins fully into the neurostimulator. 10 English 2012-06 97715 2012-06 M946871A001 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 Note: Insert a connector plug (from an accessory kit) into any unused neurostimulator socket. 4. For each extension, lead, or plug, fully insert the torque wrench (packaged with the rechargeable neurostimulation system) into each self-sealing grommet of the connector block and tighten each setscrew (Figure 2). # Cautions: ▪ Be sure the torque wrench is fully inserted into the self-sealing grommet. If the torque wrench is not fully inserted, the setscrew may be damaged, resulting in intermittent or loss of stimulation. ▪ Before tightening setscrews, ensure that the extension or lead connector pins are inserted into the connector block to prevent damaging the lead or extension. ▪ Verify that each leaf of the self-sealing grommet is closed after the torque wrench is withdrawn. If fluid leaks through a grommet seal that is not fully closed, the patient may experience shocking, burning, or irritation at the neurostimulator implant location, or intermittent stimulation, or loss of stimulation. Figure 2. Tightening the setscrews in the self-sealing grommet. Implanting the neurostimulator 1. Place the neurostimulator into the subcutaneous pocket using the pocket sizer if desired and ensure that the extension or lead is not bent sharply. The neurostimulator can be implanted and charged with either side facing outward. for optimal recharging, place the neurostimulator 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) below the skin and is parallel to the skin. If the neurostimulator is too deep or is not parallel to the skin, recharge may be inefficient or unsuccessful. 97715 M946871A001 2012-06 English 11 2012-06 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) ▪ Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 Do not coil excess extension in front of the neurostimulator. Wrap excess extension or leads around the perimeter (Figure 3) or behind the neurostimulator to help minimize potential damage during neurostimulator replacement 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 muscle fascia with nonabsorbable silk. Note: Secure the neurostimulator in the pocket to minimize movement or migration of the neurostimulator. Checking system integrity The connections of the extensions and leads to the neurostimulator can be checked using the clinician programmer. Refer to the programming guide for detailed programming instructions. w Warning: To use the nonsterile programmer system components in a sterile field, place a sterile barrier between the patient and system components to prevent infection. Do not sterilize any components of the programmer system. Sterilization may damage the components. 1. To ensure proper connection of each extension or lead to the neurostimulator, use the clinician programmer to perform the lead insertion check. 2. If the lead insertion check results are not acceptable, refer to "Connecting the extension or lead to the neurostimulator". Completing the implant procedure 1. 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 2012-06 97715 2012-06 M946871A001 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 4. Complete the device tracking and patient registration paperwork and return the documents to Medtronic. 97715 M946871A001 2012-06 English 13 2012-06 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 Contacts: Asia: Medtronic International Ltd. Tel. 02891-4068 Fax 02591-0313 Medtronic Asia Ltd. Tel. (02)-548-1148 Fax (02)-518-4786 Australia: Medtronic Australasia Pty. Ltd. 97 Waterloo Road North Ryde, NSW 2113 Australia Tel. +61-2-9857-9000 Fax +61-2-9878-5100 Toll free 1-800-668-6700 Austria: Medtronic Österreich GmbH Tel. 01-240440 Fax 01-24044-100 Belgium: Medtronic Belgium S.A. Tel. 02-456-0900 Fax 02-460-2667 Canada: Medtronic of Canada Ltd. Tel. (1-905)-460-3800 Fax (1905)-826-6620 Czech Republic: Medtronic Czechia s.r.o. Tel. 2-965-795-80 Fax 2-965-795-89 Denmark: Medtronic Danmark A/S Tel. 45-32-48-18-00 Fax 45-32-48-18-01 Finland: Medtronic Finland Oy/LTD Tel. (09)-755-2500 Fax (09)-755-25018 France: Medtronic France S.A.S. Tel. 01-5538-1700 Fax 01-5538-1800 Germany: Medtronic GmbH Tel. (02159)-81490 Fax (02159)-8149100 Greece: Medtronic Hellas S.A. Tel. 210-67-79-099 Fax 210-67-79-399 2012-06 Hungary: Medtronic Hungária Kft. Tel. 1-889-06-00 Fax 1-889-06-99 Ireland: Medtronic Ireland Ltd. Tel. (01)-890-6522 Fax (01)-890-7220 Italy: Medtronic Italia SpA Tel. 02-241371 Fax 02-241381 Tel. 06-328141 Fax 06-3215812 Japan: Medtronic Japan Tel. 3-6430-2016 Fax 3-6430-7110 Latin America: Medtronic, Inc. Tel. (1305)-500-9328 Fax (1786)-709-4244 Norway: Medtronic Norge AS Tel. 067-10-32-00 Fax 067-10-32-10 Poland: Medtronic Poland Sp. z.o.o. Tel. (022)-465-69-00 Fax (022)-465-69-17 Portugal: Medtronic Portugal, Lda. Tel. 21-724-5100 Fax 21-724-5199 Russia: Medtronic Russia Tel. (8495) 580-7377 Fax (8495) 580-7378 Slovakia Medtronic Slovakia, o.z. Tel. 0268 206 911 Fax 0268 206 999 Spain: Medtronic Ibérica, S.A. Tel. 91-625-0400 Fax 91-650-7410 Sweden: Medtronic AB Tel. 08-568-585-00 Fax 08-568-585-01 M946871A001 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Switzerland: Medtronic (Schweiz) AG Tel. 031-868-0100 Fax 031-868-0199 The Netherlands: Medtronic B.V. Tel. (045)-566-8000 Fax (045)-566-8668 U.K.: Medtronic U.K. Ltd. Tel. 01923-212213 Fax 01923-241004 M946871A001 Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 USA: Medtronic, Inc. Tel. (1763)-505-5000 Fax (1763)-505-1000 Toll-free: (1-800)-328-0810 2012-06 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 Manufacturer Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. www.medtronic.com Tel. +1-763-505-5000 Fax +1-763-505-1000 Authorized Representative EC REP in the European Community Medtronic B.V. Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands Tel. +31-45-566-8000 Fax +31-45-566-8668 Europe/Africa/Middle East Headquarters Medtronic International Trading Sàrl Route du Molliau 31, Case Postale 84 CH-1131 Tolochenaz, Switzerland www.medtronic.eu Tel. +41-21-802-7000 Fax +41-21-802-7900 Asia-Pacific Medtronic International Ltd. Suite 1602 16/F, Manulife Plaza, The Lee Gardens, 33 Hysan Avenue, Causeway Bay, Hong Kong Tel. +852-2891-4068 Fax +852-2591-0313 Contacts for specific countries are listed inside this cover. *M946871A001* 2012-06 © Medtronic, Inc. 2012 All Rights Reserved M946871A001 M946871A001
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