RestoreSensor™ 37714 Implant manual Rx only
Contents
1. in the European Community Medtronic B V Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Internet www medtronic com Tel 31 45 566 8000 Fax 31 45 566 8668 Europe Africa Middle East Headquarters 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 934840A001 M All Rights Reserved M934840A001 Medtronic Inc 2011 A2. 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 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 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 15
3. gt Medtronic RestoreSensor 37714 Multi program rechargeable neurostimulator Implant manual usal Rx only C 2010 0123 Explanation of symbols on product or package labeling Refer to the appropriate product for symbols that apply en o TA e JEL ORE e z STERILE EO 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 Caution consult accompanying documents Consult instructions for use Do not reuse Date of manufacture Manufacturer Open here Use by Serial number Sterilized using ethylene oxide Authorized representative in the European community For USA audiences only Temperature limitation Chinese Standard SJ T11364 2006 Logo Electronic Information Products Pollution Control Symbol The date in this logo means the environmental protection use period of the product 37714 2011 03 English 1 Medtronic and SoftStart Stop are registered trademarks of Medtronic Inc AdaptiveStim and RestoreSensor are trademarks of Medtronic Inc 2 English 37714 2011 03 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 t
4. additional information contact the appropriate Medtronic representative listed on the inside back cover of this manual 8 English 37714 2011 03 Instructions for use Implanting physicians should be experienced in epidural access procedures and should be thoroughly familiar with all product labeling A Warning DO NOT use the recharger on an unhealed wound The recharger antenna and holder are not sterile and contact with the wound can cause an infection A Caution Advise patients to charge the neurostimulator when a Low battery CH screen is displayed on the patient programmer or recharger this prevents 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
5. 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 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 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 37714 2011 03 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 or lead to the neurostimulator A Caution Before connecting components wipe off any body fluids and
6. a short or open circuit 2 If the system integrity test results are not acceptable refer to Connecting the extension or lead to the neurostimulator on page 10 3 Complete the stimulation assessment form 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 37714 2011 03 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 6700 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 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
7. 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 PAS 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 10 English 37714 2011 03 Socket Il Electrodes 8 15 Socket Electrodes 0 7 Extension or Lead 1 Extension or Lead 2 S Figure 1 Insert the extension or lead connector pins fully into the neurostimulator Note Insert a connector plug from an accessory kit into any unused neurostimulator socket For each extension lead or plug fully insert the torque
8. he extension or lead 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 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 USA Refer to the clinical summary booklet for information on the clinical study results of the neurostimulation system and individualization of treatment 37714 2011 03 English 3 4 English 37714 2011 03 Description The Medtronic RestoreSensor Model 37714 Neurostimulator is part of a neurostimulation system for pain therapy 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 whe
9. im 1 to 85 1 to 45 2 to 16 electrodes as anode cathode or OFF 0 to 10 5 V with 0 05 V or 0 1 V resolution Tracking limit programmed value 0 to 4 V 0 5 V resolution Custom limit programmed value to 10 5 V same resolution as amplitude Custom limit O V to the programmed value same resolution as amplitude 60 to 1000 us 10 us resolution Tracking limit programmed value 0 to 300 us 60 us resolution Custom limit programmed value to 1000 us 10 us resolution Custom limit 60 us to the programmed value 10 us resolution 2 to 1200 Hz resolution 1 Hz from 2 Hz to 10 Hz 5 Hz from 10 Hz to 250 Hz 10 Hz from 250 Hz to 500 Hz 20 Hz from 500 Hz to 1000 Hz 50 Hz from 1000 Hz to 1200 Hz Tracking limit programmed value 0 10 20 50 100 Hz Custom limit programmed value to 1200 Hz same resolution as rate Custom limit 2 to the programmed value same resolution as rate OFF ON 1 2 4 or 8 second ramp duration OFF ON 0 1 s to 30 min resolution 0 1 s from 0 1sto1s 1s from 1 s to 1 min 1 min from 1 min to 30 min OFF ON 6 positions a Interlocks will prevent the use of some parameter combinations b No more than 16 programs may be defined within the 8 groups Pulse width and rate limits not available for groups with AdaptiveStim enabled d Rate limited to 600 Hz when 2 programs per group are active 400 Hz when 3 programs per group are active and 300 Hz when 4 programs per group a
10. n 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 A program is a specific combination of pulse width rate and amplitude settings acting on a specific electrode combination up to 16 electrodes per program Up to 4 programs can be combined into a group When using more than 1 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 37714 2011 03 English 5 Table 1 Operating values for the RestoreSensor Model 37714 Neurostimulator Programmable parameter Operating range and resolution Number of defined groups Number of programs per group Electrode configuration Amplitude Amplitude upper patient limit Amplitude lower patient limit Pulse width Pulse width upper patient limite Pulse width lower patient limite Rate Rate upper patient limit Rate lower patient limit SoftStart Stop Cycling AdaptiveSt
11. re active 6 English 37714 2011 03 Table 2 Physical characteristics of the RestoreSensor Model 37714 Neurostimulator Description Value Connector type Octapolar in line 2 8 mm 0 110 in spacing Height 54 0 mm 2 1 in Length 54 0 mm 2 1 in Thickness case 9 0 mm 0 4 in connector 11 0 mm 0 4 in Weight 45 0 g 1 6 oz Volume 22 0 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 NKS Radiopaque identification ID code NKD a All measurements are approximate b The serial number is the model designator followed by a number The clinician programmer displays the entire serial number beginning with the model designator 37714 2011 03 English 7 Table 3 Material of components in the RestoreSensor Model 37714 package Components Material Material contacts human tissue Neurostimulator Case Titanium 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 Ultem 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
12. utward If implanted with the Medtronic logo facing inward the neurostimulator cannot be charged Do not coil excess extensions or leads in front of the neurostimulator Wrap excess extensions 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 12 English 37714 2011 03 PR Figure 3 Wrap excess extensions or leads around the perimeter or behind 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 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 or lead 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
13. wrench packaged with the rechargeable neurostimulation system into each self sealing grommet of the connector block and tighten each setscrew Figure 2 A 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 37714 2011 03 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 or lead is not bent sharply Cautions 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 o
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