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Medtronic Activa RC 37612, Implant Manual, Page: 10 / 18

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Medtronic Activa RC 37612 Implant Manual Download Page 10

 

Table 3. Material of components in the Activa RC Model 37612 package

 

Components

Material

Material contacts 
human tissue

Neurostimulator

Case

Titanium

Yes

Connector block

Polysulfone, silicone rubber,
silicone medical adhesive

Yes

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 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.

10

 

English

  

37612

 

2016-06-01

Summary of Contents for Activa RC 37612

Page 1: ...Activa RC 37612 Multi program rechargeable neurostimulator Implant manual Rx only 2008 ...

Page 2: ......

Page 3: ...e by XXX F XX C XX F XX C Temperature limitation Serial number Consult instructions for use Conformité Européenne 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 STERILIZE 2 Do not resterilize Do not use if package is damaged For USA audiences only PIN No Pin number 37612 2016 06 ...

Page 4: ...Medtronic Activa and SoftStart Stop are trademarks of Medtronic Inc registered in the U S and other countries 4 English 37612 2016 06 01 ...

Page 5: ...rmation 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...

Page 6: ...6 English 37612 2016 06 01 ...

Page 7: ...ranties 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 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...

Page 8: ...dth upper patient limit Tracking limit 0 to 100 µs 10 µs resolution Pulse width lower patient limit Tracking limit 0 to 100 µs 10 µs resolution Rate voltage mode 2 to 250 Hz resolution 1 Hz from 2 Hz to 10 Hz 5 Hz from 10 Hz to 250 Hz d Rate current mode 30 to 250 Hz 5 Hz resolution d Rate upper patient limit Tracking limit 0 to 50 Hz 10 Hz resolution Rate lower patient limit Tracking limit 0 to 5...

Page 9: ...age temperature 18 to 52 C 0 to 126 F Serial number model designatorc NKG Radiopaque Identification ID code NKG Transmitter Carrier frequency 175 kHz Output level at 300 m 48 dBuV m 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 c The serial number is the model des...

Page 10: ...es 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 90 385 EEC on Active Implantable Medical Devices For additional information contact the appropriate Medtronic representative listed on the...

Page 11: ...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 se...

Page 12: ...f 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 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...

Page 13: ...ufficient 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 Before tightening setscrews ensure that the extension connector is inserted into the connector block to preve...

Page 14: ...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 excess extension around the perimeter Figure 3 of the neurostimulator to minimize subcutaneous pocket depth help minimize potential damage during neurostimulator replacement surger...

Page 15: ...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 If the system integrity test results are not acceptable refer to Connecti...

Page 16: ...1 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 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 03 6776 0017 Fa...

Page 17: ...9 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 ...

Page 18: ... 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 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...

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