Activa PC Multi-program neurostimulator 37601 Implant manual Rx only 2008 Explanation of symbols on product or package labeling Refer to the appropriate product for symbols that apply. Open here Do not reuse STERILE EO Sterilized using ethylene oxide Date of manufacture Manufacturer Use by
+XX C
+XXX F Temperature limitation
-XX C
-XX F Serial number Consult instructions for use Do not use if package is damaged 2 STERILIZE Do not resterilize Conformit Europenne (European Conformity). This symbol means that the device fully complies with AIMD Directive 90/385/EEC (NB 0123). EC REP Authorized representative in the European Community For USA audiences only 376012016-06-01English3 PIN No. Pin number 4English376012016-06-01 Medtronic, Activa, and SoftStart/Stop are trademarks of Medtronic, Inc., registered in the U.S. and other countries. 376012016-06-01English5 6English376012016-06-01 Table of contents Description 9 Package contents 9 Patient identification card 9 Device specifications 9 Declaration of conformity 12 Instructions for use 13 Verifying neurostimulator operation 13 Connecting the extension to the neurostimulator 13 Implanting the neurostimulator 15 Checking system integrity 16 Completing the implant procedure 16 Refer to the indications sheet for indications and related information. Refer to the appropriate information for prescribers booklet and any additional associated product information for contraindications, warnings, precautions, component disposal, and other important device therapy information. Refer to the MRI Guidelines for Medtronic Deep Brain Stimulation Systems instructions for use manual for the MRI conditions and MRI-specific contraindication, warnings, and precautions for conducting an MRI scan. Refer to the System Eligibility Battery Longevity reference manual for neurostimulator selection and battery longevity calculations.
! USA Refer to the clinical summary booklet for information on the clinical study results of the neurostimulation system. 376012016-06-01English7 8English376012016-06-01 Description The Medtronic Activa PC Model 37601 Neurostimulator is part of a neurostimulation system for deep brain stimulation. Package contents Neurostimulator Torque wrench Product literature Registration form Patient identification card
! USA 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 Medtronics implant data system. Device specifications The neurostimulator is a multi-programmable device that delivers 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. When using more than one program, the pulses are delivered sequentiallyfirst 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, SoftStart/Stop and cycling for each program within the group have the same values. 376012016-06-01English9 Table 1. Operating values for the Activa PC Model 37601 neurostimulator Amplitude lower patient limit Amplitude (voltage mode) Amplitude (current mode) Amplitude upper patient limit Programmable parameter Number of defined groups Number of programs per group Electrode configurationb Operating range and resolutiona 1 to 4 1 to 4 1 to 4 electrodes per lead 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 Tracking limit (by hemisphere): +0 to +2 (0.2 resolution);
+2 to +4.5 (0.5 resolution) Tracking limit (by hemisphere): -0 to -2 (0.2 resolution);
-2 to -4.0 (0.5 resolution); full rangec 60 to 450 s (10-s resolution) Tracking limit: +0 to +100 s (10-s resolution) Tracking limit: -0 to -100 s (10-s resolution) 2 to 250 Hz (resolution: 1 Hz from 2 Hz to 10 Hz, 5 Hz from 10 Hz to 250 Hz)d 30 to 250 Hz (5-Hz resolution)d 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 s to 1 s, 1 s from 1 s to 59 s, 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 In current mode, a maximum of 2 electrodes (including the case) can be configured as anode (+) and Rate (current mode) Rate upper patient limit Rate lower patient limit SoftStart/Stop Cycling Pulse width Pulse width upper patient limit Pulse width lower patient limit Rate (voltage mode) cathode (). c 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. 10English376012016-06-01 Table 2. Physical characteristics of the Activa PC Model 37601 neurostimulatora Description Connector type Height Length Thickness case connector Weight Volume Power source Temperature limitation Serial number model designatorc Radiopaque Identification (ID) code Transmitter Carrier frequency Output level (at 300 m) Value Octapolar, in-line 2.8-mm (0.110-in) spacing 65.0 mm (2.6 in) 49.0 mm (1.9 in) 15.0 mm (0.6 in) 15.0 mm (0.6 in) 67.0 g (2.4 oz) 39.0 cm3 6.3 Amp hours, 3.2 V HCSVOb cell 18 to +52 C (0 to +126 F) NKM NKD 175 kHz
-45.8 dBuV/m a All measurements are approximate. b Hybrid combined silver vanadium oxide. c The serial number is the model designator followed by a number. The clinician programmer displays the entire serial number beginning with the model designator. 376012016-06-01English11 Table 3. Material of components in the Activa PC Model 37601 package Components Material Material contacts human tissue Neurostimulator Case Connector block Grommets, seals Setscrews Adhesive Torque wrench Handle Shaft Titanium Polyurethane, silicone rubber, silicone medical adhesive Silicone rubber Titanium alloy Silicone medical adhesive Polyetherimide Stainless steel Yes Yes Yes Yes Yes Yes Yes Declaration of conformity Medtronic declares that this product is in conformity with the essential requirements of 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. 12English376012016-06-01 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 deep brain stimulation procedures, as well as thoroughly familiar with all product labeling. Cautions:
When using sharp instruments near the neurostimulator, be extremely careful to avoid nicking or damaging the case 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. 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 service life. (Refer to the software manual for instructions on how to read the battery service life.) 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 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 nonionic antibiotic solution. 2. Make sure the connector block receptacles are dry and clean. 3. If using two leads, identify the left and right lead-extensions. Note: It may be necessary to tug gently on either lead-extension and view its movement at the lead site to identify left and right lead-extensions. 376012016-06-01English13 4. Insert each extension connector into the appropriate neurostimulator socket until it is fully seated within the connector block (Figure 1). Notes:
Insert the identified left extension into the front (0-7) neurostimulator socket
(socket I) and the right extension into the back (8-15) neurostimulator socket
(socket II) to simplify electrode assignment during programming. 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 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. Socket I (Electrodes 0-7) Socket II (Electrodes 8-15) Extension 2 Extension 1 Figure 1. Insert the extension connectors fully into the neurostimulator socket. Note: Insert a neurostimulator plug (from the extension kit) into an unused neurostimulator socket. 5. 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). 14English376012016-06-01 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 stimulation. 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. into the connector block to prevent damaging the extension. Before tightening setscrews, ensure that the extension connector is inserted 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 with the Medtronic logo facing outward, away from muscle tissue, and ensure that the extension is not bent sharply. Cautions:
Ensure that the neurostimulator is placed no deeper than 4 cm (1.5 in) below the skin and is parallel to the skin. If the neurostimulator is too deep or is not parallel to the skin, telemetry may be unsuccessful. Do not coil excess extension in front of the neurostimulator. Wrap excess extension around the perimeter (Figure 3) of the neurostimulator to minimize subcutaneous pocket depth, help minimize potential damage during 376012016-06-01English15 neurostimulator replacement surgery, help minimize potential kinking of the extension, and minimize interference with telemetry. Excess extension should not exceed two wraps around the perimeter of the neurostimulator. Extension lengths requiring more than two wraps can interfere with telemetry. 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. 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 of the 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 left and right lead assignments and the basic stimulation parameters, check the battery status, and check the electrode impedances to rule out a short or open circuit. If the system integrity test results are not acceptable, refer to "Connecting the extension to the neurostimulator" on page 13. 2. Completing the implant procedure 1. Close and dress all incisions. 2. Ensure that a patient control device is given to the patient. 16English376012016-06-01 3. Complete the device tracking and patient registration paperwork and return the documents to Medtronic. 376012016-06-01English17 Contacts:
Asia:
Medtronic International Ltd. Tel. 02919-1300 Fax 02891-6830 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 sterreich 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 Hungary:
Medtronic Hungria 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. 03-6776-0017 Fax 03-6774-4645 Latin America:
Medtronic, Inc. Tel. (1305)-500-9328 Fax (1786)-709-4244 Norway:
Medtronic Norge AS Tel. 67-10-32-00 Fax 67-10-32-10 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 Ibrica, 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 Turkey:
Medtronic Turkey Tel. +90 216 636 1000 Fax +90 216 636 1008 U.K.:
Medtronic U.K. Ltd. Tel. 01923-212213 Fax 01923-241004 USA:
Medtronic, Inc. Tel. (1-763)-505-5000 Fax (1-763)-505-1000 Toll-free: (1-800)-328-0810 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 Srl 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 1106-11, 11/F, Tower 1, The Gateway, 25 Canton Road, Tsimshatsui, Kowloon, Hong Kong Tel. +852-2919-1300 Fax +852-2891-6830 Contacts for specific countries are listed inside this cover.
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Medtronic, Inc. 2016 All Rights Reserved M929110A053 Rev A