Activa® RC 37612 Implant manual Rx only
Contents
1. a All measurements are approximate b The neurostimulator is not shipped with a full battery charge Refer to the charging system user manual for neurostimulator charging instructions The serial number is the model designator followed by a number The clinician programmer displays the entire serial number beginning with the model designator 37612 2010 08 English 7 Table 3 Material of components in the Activa RC Model 37612 package Components Material Material contacts human tissue Neurostimulator Case Titanium parylene Yes Connector block Polysulfone silicone rubber Yes silicone medical adhesive Grommets seals Silicone rubber Yes Setscrews Titanium alloy Yes Adhesive Silicone medical adhesive Yes Torque wrench Handle Polyetherimide Yes Shaft Stainless steel Yes 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 contactthe appropriate Medtronic representative listed on the inside back cover of this manual 8 English 37612 2010 08 Instructions for use Implanting physicians should be experienced in stereotactic and functional neurosurgery and have expertise with functional stereotactic neurosurgical treatment of movement disorders and should be thoroughly familiar with all p2. 241381 Tel 06 328141 Fax 06 3215812 Japan Medtronic Japan Tel 3 6430 2011 Fax 3 6430 7140 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 0 0 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 Ib rica S A Tel 91 625 0400 Fax 91 650 7410 Sweden Medtronic AB Tel 08 568 585 00 Fax 08 568 585 01 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 USA Medtronic Inc Tel 1763 505 5000 Fax 1763 505 1000 Toll free 1 800 328 0810 Medtronic Alleviating Pain Restoring Health Extending Life Manufacturer eae Medtronic Inc 710 Medtronic Parkway Minneapolis MN 55432 5604 USA Internet www medtronic com Tel 1 763 505 5000 Fax 1 763 505 1000 Authorized Representative E FE 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 Headquarte
3. Sr Medtronic Activa RC 37612 Multi program rechargeable neurostimulator Implant manual TUSA Rx only CE 2008 0123 Explanation of symbols on product or package labeling Refer to the appropriate product for symbols that apply A STERILE EO Open here Do not reuse Sterilization ethylene oxide gas Caution consult accompanying documents Date of manufacture Manufacturer Use by Temperature limitation Serial number Conformit Europ enne European Conformity This symbol means that the device fully complies with AIMD Directive 90 385 EEC NB 0123 and R amp TTE Directive 1999 5 EC Authorized representative in the European community For USA audiences only 37612 2010 08 English 1 Medtronic and Activa are registered trademarks of Medtronic Inc SoftStart Stop is a trademark of Medtronic Inc 2 English 37612 2010 08 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 to the neurostimulator 10 Implanting the neurostimulator 12 Checking system integrity 13 Completing the implant procedure 13 Refer to the indications sheet for indications and related information Refer to the appropriate information for prescribers boo
4. e 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 Charge the neurostimulator battery before opening the package For charging instructions refer to the charging system user manual 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 software manual for instructions on how to read the battery charge level 37612 2010 08 English 9 A 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 Connecting the extension to the neurostimulator VAN 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 connectors with sterile gauze If necessary use sterile United States Pharmacopeia USP water or a nonio
5. elivers stimulation through 1 or 2 leads The stimulation settings are stored in programs A program is a specific combination of pulse width rate and amplitude settings acting on a specific electrode combination Up to four programs can be combined into a group with a maximum of 2 programs per lead When using more than one program the pulses are delivered sequentially first a pulse from one program then a pulse from the next program Pulse width amplitude and electrode polarity for each program within the group can have different values Rate rate limits ramping and cycling for each program within the group have the same values 37612 2010 08 English 5 Table 1 Operating values for the Activa RC Model 37612 neurostimulator Programmable parameter Operating range and resolution Number of defined groups Number of programs per group Electrode configuration Amplitude voltage mode Amplitude current mode Amplitude upper patient limit Amplitude lower patient limit Pulse width Pulse width upper patient limit Pulse width lower patient limit Rate voltage mode Rate current mode Rate upper patient limit Rate lower patient limit SoftStart Stop Cycling 1 to 4P 1 to 4P Up to 4 electrodes as anode cathode or OFF Case defined as anode or OFF 0 to 10 5 V with 0 05 V or 0 1 V resolution 0 to 25 5 mA with 0 1 mA resolution By hemisphere Tracking limit 0 to 2 0 2 resolut
6. ess extension around the perimeter Figure 3 of the neurostimulator to minimize subcutaneous pocket depth help minimize potential damage during neurostimulator replacement surgery help minimize potential kinking of the extension and minimize interference with telemetry and recharge operation Excess extension should not exceed two wraps around the perimeter of the neurostimulator Extension lengths requiring more than two wraps can interfere with telemetry 37612 2010 08 gt DR Figure 3 Wrap excess extensions 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 Checking system integrity Caution To use the nonsterile clinician programmer in a sterile field place a sterile barrier between the patient and the programming head to prevent infection Do not sterilize any part ofthe clinician programmer Sterilization may damage the programmer Note The neurostimulator should be in the pocket during system interrogation for integrity to ensure proper readings 1 To ensure proper connection of each extension to the neurostimulator use the clinician programmer to program the basic stimulation parameters check the battery status and check the electrode impedances to rule out a short or open circuit 2 Ifthe system integrity test results are not acceptable refer to Connecting the extension to the neurostimulator o
7. imulation 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 connector is inserted into the connector block to prevent damaging the 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 37612 2010 08 English 11 Figure 2 Tightening the setscrews in the self sealing grommet Implanting the neurostimulator 1 Place the neurostimulator into the subcutaneous pocket with the Medtronic logo facing outward away from muscle tissue and ensure that the extension is not bent sharply A Cautions 12 English Ensure that the neurostimulator is placed no deeper than 1 cm 0 4 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 Position the neurostimulator with the Medtronic logo facing outward If implanted with the Medtronic logo facing inward the neurostimulator will be difficult to charge Do not coil excess extension in front of the neurostimulator Wrap exc
8. ion 2 to 4 5 0 5 resolution By hemisphere Tracking limit 0 to 2 0 2 resolution 2 to 4 0 0 5 resolution full range 60 to 450 us 10 us resolution Tracking limit 0 to 100 us 10 us resolution Tracking limit 0 to 100 us 10 us resolution 2 to 250 Hz resolution 1 Hz from 2 Hz to 10 Hz 5 Hz from 10 Hz to 250 Hz 4 30 to 250 Hz 5 Hz resolution 4 Tracking limit 0 to 50 Hz 10 Hz resolution Tracking limit 0 to 50 Hz 10 Hz resolution OFF ON 1 2 4 or 8 second ramp duration OFF ON 0 1 s to 24 hr resolution 0 1 s from 0 1 sto 1s 1s from 1 sto 59s 1 min from 1 min to 59 min 1 hr from 1 hr to 24 hr a Interlocks will prevent the use of some parameter combinations b No more than 16 programs may be defined within the 4 groups Full range 10 5 V voltage mode 25 5 mA current mode d Rate limited to 125 Hz when two programs are active on a single lead 6 English 37612 2010 08 Table 2 Physical characteristics of the Activa RC Model 37612 neurostimulator Description Value Connector type Octapolar in line 2 8 mm 0 110 in spacing Height 54 mm 2 1 in Length 54 mm 2 1 in Thickness case 9 mm 0 4 in connector 11mm 0 4 in Weight 40 g 1 6 oz Volume 22 cm Battery life 9 years Power source Lithium ion rechargeable battery Storage temperature 18 to 52 C 0 to 126 F Serial number model designator NKG Radiopaque Identification ID code NKG
9. klet and any other additional information packaged with the product for contraindications warnings precautions component disposal and other important device therapy information Refer to System Eligibility Battery Longevity Specifications reference manual packaged with the software application card for neurostimulator selection and battery longevity calculations USA Refer to the clinical summary booklet packaged with the neurostimulator for information on the clinical study results of the neurostimulation system 37612 2010 08 English 3 4 English 37612 2010 08 Description The Medtronic Activa RC Model 37612 Neurostimulator is part of a neurostimulation system for deep brain stimulation Package contents Neurostimulator Torque wrench Product literature Warranty card USA only Registration form Patient identification 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 d
10. n page 10 Completing the implant procedure 1 Close and dress all incisions 2 Ensure that a patient control device is given to the patient 3 Complete the device tracking and patient registration paperwork and return the documents to Medtronic 37612 2010 08 English 13 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 1 800 668 670 Austria Medtronic Osterreich 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 1905 826 6020 Fax 1905 826 6620 Czech Republic Medtronic Czechia s r 0 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 Hungary Medtronic Hungaria 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
11. nic antibiotic solution 2 Make sure the connector block receptacles are dry and clean 3 Insert each extension connector into the appropriate neurostimulator socket until it is 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 A Caution Do not insert the extension connector into the connector block if the setscrews are not sufficiently retracted If the setscrews are not retracted the setscrews may damage the extension and the extension will not be seated fully into the connector block 10 English 37612 2010 08 Socket Il Electrodes 8 15 Socket Electrodes 0 7 Extension 1 Extension 2 Ss Figure 1 Insert the extension connectors into the neurostimulator Note Insert a connector plug from an accessory kit into unused neurostimulator socket For each extension or plug fully insert the torque wrench packaged with the neurostimulator into each self sealing grommet of the connector block and tighten each setscrew Figure 2 Cautions To prevent undertightening the neurostimulator setscrews do not use the torque wrench from the extension kit Undertightening may result in insufficient electrical contact within the connector block which may cause intermittent st
12. roduct labeling A Warning DO NOT use the recharger on an unhealed wound The recharger antenna and holster are not sterile and contact with the wound can cause an infection Ls Caution Advise patients to charge the neurostimulator on a regular basis taking into consideration the therapeutic parameters and battery usage of the patient to prevent the battery from overdischarging If the neurostimulator battery is allowed to overdischarge the patient cannot charge the neurostimulator however the clinician may be able to restore the battery function using the Physician Recharge Mode on the recharger refer to the troubleshooting section of the software manual Allowing the neurostimulator battery to overdischarge will permanently affect the neurostimulator in one of the following ways Battery function is restored however charging sessions may be more frequent because battery capacity has been reduced Battery function is not restored and the neurostimulator must be surgically replaced Battery function is not restored when the neurostimulator battery is permanently damaged the neurostimulator battery has been overdischarged and restored twice before The third time the battery is overdischarged the neurostimulator will reach end of service Surgery is required to replace the neurostimulator A Cautions When using sharp instruments near the neurostimulator be extremely careful to avoid nicking or damaging th
13. rs Medtronic International Trading Sarl Route du Molliau 31 Case Postale 84 CH 1131 Tolochenaz Switzerland Internet www medtronic com 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 927170A010 M All Rights Reserved M927170A010 Medtronic Inc 2010 A
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