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1 | Regulatory Statements | Users Manual | 592.75 KiB |
97714 Communications Regulation Reference Sheet Manufacturer Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA www.medtronic.com Tel. +1-763-505-5000 Authorized Representative EC REP in the European Community Medtronic B.V. Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands Tel. +31-45-566-8000 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 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 Medtronic, Inc. 2017 All Rights Reserved M969828A002 Rev A Communications Regulations The following is a list of communications regulations that apply to the Model 97714. United States Compliance FCC ID: LF597714 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., could void the FCC Certification and negate your authority to operate this product. IC: CANADA310 Canada Compliance This device complies with Industry Canada's RSS-310. Operation is subject to the condition that this device must not cause harmful interference and must accept any interference, including interference that may cause undesired operation of the device. Cet appareil est conforme au CNR-310 dIndustrie Canada. Son exploitation est autorise condition que lappareil ne produise pas de brouillage prjudiciable et quil accepte tout brouillage, mme celui susceptible den compromettre le fonctionnement. This product operates at 175 kHz with an H-field strength of less than 30 dBA/m at 10 m. Ce produit fonctionne 175 kHz avec une intensit de champ H infrieure 30 dBA/m 10 m. Brazil Compliance 2085-16-5567 This equipment operates on a secondary basis and, consequently, must accept harmful interference, including from stations of the same kind, and may not cause harmful interference to systems operating on a primary basis. Este equipamento opera em carter secundrio isto , no tem direito proteo contra interferncia prejudicial, mesmo de estaes do mesmo tipo, e no pode causar interferncia a sistemas operando em carter primrio. Korea Compliance MSIP-RMI-MKL-97714 This radio device has possibility of radio interference during operation.
*M969828A002*
2018-04-01 Singapore Compliance HIDF15000146 Dealer License # DA103452 This product complies with IDA Standards.
IDA
Malaysia Compliance HIDF15000146 This product conforms to Malaysia Radio Requirement. Produk ini mematuhi Keperluan Radio Malaysia. Australia and New Zealand Compliance This product conforms to Australia and New Zealand Radio Requirements. Argentina Compliance CNC ID: H-17430 This product conforms to Argentina Radio Requirements. Este producto cumple los requisitos de Argentina relativos a la radioelectricidad. European Union Compliance Conformit Europenne
(European Conformity) Hereby, Medtronic declares that this Radio Equipment Model number 97714 is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address:
www.MedtronicCompliance.eu This product operates at 175 kHz with an H-field strength of less than 30 dBA/m at 10 m. Bulgarian Medtronic
, 97714 2014/53/.
:
www.MedtronicCompliance.eu 175 kHz H 30 dBA/m 10 . Czech Spolenost Medtronic tmto prohlauje, e toto radiov zazen, slo modelu 97714, odpovd poadavkm smrnice 2014/53/EU. pln text EU Prohlen o shod je k dispozici na nsledujc internetov adrese:
www.MedtronicCompliance.eu Tento vrobek pouv frekvenci 175kHz, piem intenzita pole H je ni ne 30 dBA/m ve vzdlenosti 10m. Danish Medtronic erklrer hermed, at dette radioudstyr modelnummer 97714 er i overensstemmelse med direktiv 2014/53/EU. Den fulde tekst i EU-
overensstemmelseser-
klringen kan lses her:
www.MedtronicCompliance.eu Dette produkt fungerer ved 175 kHz med en H-feltstyrke p mindre end 30 dBA/m ved 10 m. German Hiermit erklrt Medtronic, dass dieses Funkgertmodell Nr. 97714 der Richtlinie 2014/53/EU entspricht. Der vollstndige Text der EU-
Konformittserklrung steht unter der folgenden Internetadresse zur Verfgung:
www.MedtronicCompliance.eu Dieses Produkt arbeitet mit 175 kHz und einer H-Feldstrke von weniger als 30 dBA/m in einer Entfernung von 10 m. Greek
, Medtronic M 97714 O 2014/53/E.
:
www.MedtronicCompliance.eu 175 kHz H 30 dBA/m 10 m. Spanish Por la presente, Medtronic declara que este equipo de radio, modelo nmero 97714 cumple la Directiva 2014/53/EU. El texto completo de la Declaracin de Conformidad CE est disponible en la siguiente direccin de internet:
www.MedtronicCompliance.eu Este producto opera a 175 kHz con una intensidad de campo H de menos de 30 dBA/m a 10 m. Estonian Kesolevaga kinnitab Medtronic, et see raadioseadmestik mudelinumbriga 97714 on vastavuses direktiiviga 2014/53/EL. Kogu EL-i vastavusdeklaratsiooni tekst on saadaval jrgmisel internetiaadressil:
www.MedtronicCompliance.eu See toode ttab sagedusel 175 kHz H-vlja tugevusega vhem kui 30 dBA/m 10 m juures. Finnish Medtronic vakuuttaa tten, ett tm radiolaite, mallinumero 97714, vastaa direktiivi 2014/53/EU. EU-
vaatimustenmukaisuus-
vakuutuksen koko teksti on saatavissa seuraavasta Internet-osoitteesta:
www.MedtronicCompliance.eu Tm tuote toimii 175 kHz:n taajuudella, ja sen H-kentn voimakkuus on alle 30 dBA/m 10 m:n etisyydell. French Par la prsente, Medtronic dclare que cet quipement radio Modle 97714 est conforme la directive 2014/53/UE. Le texte intgral de la dclaration de conformit de l'UE est disponible sur le site Internet:
www.MedtronicCompliance.eu Ce produit fonctionne 175 kHz avec une intensit de champ H infrieure 30 dBA/m 10 m. Croatian Ovime tvrtka Medtronic izjavljuje da je ova radijska oprema model 97714 u skladu s Direktivom 2014/53/EU. Cjelokupan tekst europske izjave o sukladnosti dostupan je na sljedeoj internetskoj stranici:
www.MedtronicCompliance.eu Ovaj proizvod radi pri frekvenciji od 175 kHz sa snagom H polja manjom od 30 dBA/m pri 10 m. Hungarian A Medtronic ezton nyilatkozza, hogy ez az 97714 tpusszm rdiberendezs megfelel a 2014/53/EU irnyelvnek. Az EU megfelelsgi nyilatkozat teljes szvege elrhet a kvetkez internetes cmen:
www.MedtronicCompliance.eu Ez a termk 175 kHz-en gy mkdik, hogy mgneses trerssge 10 m tvolsgban kevesebb, mint 30 dBA/m. Italian Con il presente documento, Medtronic dichiara che la presente apparecchiatura radio modello 97714 conforme alla direttiva 2014/53/UE. Il testo completo della dichiarazione UE di conformit disponibile su Internet al seguente indirizzo:
www.MedtronicCompliance.eu Questo prodotto funziona a 175 kHz con intensit di campo H inferiore a 30 dBA/m a 10 m. Lithuanian iuo Medtronic deklaruoja, kad is radijo rangos modelis, kurio numeris 97714, atitinka Direktyv 2014/53/EB. Vis ES atitikties deklaracijos tekst galite rasti iuo interneto adresu:
www.MedtronicCompliance.eu is gaminys veikia 175 kHz daniu, kai H lauko stiprumas yra maesnis nei 30 dBA/m 10 m atstumu. Latvian Ar o uzmums Medtronic apliecina, ka radioiekrta, modea numurs 97714, atbilst Direktvas 2014/53/EK prasbm. Pilnu ES atbilstbas deklarcijas tekstu var skatt vietn www.MedtronicCompliance.eu is izstrdjums darbojas ar 175 kHz frekvenci, un 10 metru attlum t magntisk lauka stiprums ir mazks par 30 dBA/m. Dutch Hierbij verklaart Medtronic dat deze radioapparatuur modelnummer 97714 in overeenstemming is met Richtlijn 2014/53/EU. De volledige tekst van de Europese conformiteitsverklaring is te vinden op de website:
www.MedtronicCompliance.eu Dit product werkt op 175 kHz met een H-veldsterkte van minder dan 30 dBA/m bij 10 m. Polish Firma Medtronic deklaruje niniejszym, e to urzdzenie radiowe, model numer 97714, spenia wymogi okrelone w Dyrektywie 2014/53/UE. Peny tekst deklaracji zgodnoci UE jest dostpny pod nastpujcym adresem internetowym:
www.MedtronicCompliance.eu Ten produkt dziaa na czstotliwoci 175 kHz z nateniem pola H mniejszym ni 30 dBA/m w odlegoci 10 m. Portuguese Por este meio, a Medtronic declara que este modelo de equipamento de rdio, nmero 97714, est em conformidade com a Diretiva 2014/53/UE. O texto completo da declarao de conformidade da UE est disponvel no seguinte endereo da Internet:
www.MedtronicCompliance.eu Este produto opera a 175 kHz com uma fora do campo H inferior a 30 dBA/m a 10 m. Romanian Prin prezenta, Medtronic declar c acest echipament radio numr model 97714 este n conformitate cu Directiva 2014/53/UE. Textul complet al declaraiei de conformitate UE poate fi gsit la urmtoarea adres de internet:
www.MedtronicCompliance.eu Acest produs funcioneaz la 175 kHz cu o putere a cmpului H de mai puin de 30 dBA/m la 10 m. Slovak Spolonos Medtronic tmto vyhlasuje, e toto rdiov zariadenie, model 97714, je v slade so smernicou 2014/53/E. pln znenie vyhlsenia o zhode so smernicami E je k dispozcii na strnke:
www.MedtronicCompliance.eu Toto zariadenie pracuje pri frekvencii 175 kHz s intenzitou poa H niou ako 30 dBA/m na vzdialenos 10 m. Slovenian Druba Medtronic izjavlja, da je ta radijska oprema, tevilka modela 97714, v skladu z Direktivo 2014/53/EU. Celotno besedilo izjave EU o skladnosti je na voljo na naslednjem spletnem naslovu:
www.MedtronicCompliance.eu Ta izdelek deluje pri 175 kHz z jakostjo magnetnega polja H manj kot 30 dBA/m pri 10 m. Swedish Hrmed intygar Medtronic att denna radioutrustning med modellnummer 97714 verensstmmer med direktiv 2014/53/EU. Den fullstndiga texten med intyg om verensstmmelse fr EU finns p fljande internetadress:
www.MedtronicCompliance.eu Den hr produkten fungerar p 175 kHz med en H-fltstyrka p mindre n 30 dBA/m p 10 m. Maltese Hawnhekk, Medtronic tiddikjara li dan it-Tagmir tar-Radju bin-
numru tal-mudell 97714 huwa konformi mad-Direttiva 2014/53/UE. It-test si tad-
dikjarazzjoni ta konformit tal-
UE hu disponibbli fdan l-
indirizz fuq l-Internet:
www.MedtronicCompliance.eu Dan il-prodott jopera f175 kHz bqawwa H-field ta inqas minn 30 dBA/m f'distanza ta' 10 m.
1 | User Manual | Users Manual | 648.88 KiB |
RestoreSensor SureScan MRI Rechargeable neurostimulator 97714 Implant manual Rx only 2013 Explanation of symbols on product or package labeling Refer to the appropriate product for symbols that apply. Open here Do not use if package is damaged Do not reuse 2 STERILIZE Do not resterilize STERILE EO Sterilized using ethylene oxide Consult instructions for use Date of manufacture Manufacturer Use by XX C XXX F Temperature limitation
-XX C
-XX F Serial number 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 977142016-06-01English3 Medtronic, AdaptiveStim, RestoreSensor, SoftStart/Stop, and SureScan are trademarks of Medtronic, Inc., registered in the U.S. and other countries. 4English977142016-06-01 Table of contents Description 7 Neurostimulation systems with SureScan MRI Technology 7 Package contents 7 Patient identification card 7 Device specifications 7 Declaration of conformity 11 Implanted components and MRI scans 12 Implant criteria for full-body MRI scan eligibility 12 When changing components 12 When explanting components 13 Instructions for use 13 Charging the neurostimulator battery 13 Verifying neurostimulator operation 14 Connecting the extension or lead to the neurostimulator 14 Implanting the neurostimulator 16 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 the MRI Guidelines for Medtronic Neurostimulation Systems for Chronic Pain instructions for use manual for the MRI conditions and MRI-specific warnings and precautions for conducting an MRI scan. Refer to the 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. 977142016-06-01English5 Checking system integrity 18 Completing the implant procedure 18 6English977142016-06-01 Description The Medtronic RestoreSensor SureScan MRI Model 97714 Neurostimulator is part of a neurostimulation system for pain therapy. Neurostimulation systems with SureScan MRI Technology When a Medtronic neurostimulation system with SureScan MRI Technology is implanted as directed (see "Implant criteria for full-body MRI scan eligibility" on page 12), a patient's full body may be eligible for MRI scans under specific conditions, ie, any part of the patient's anatomy can be scanned when specific conditions are met. For the MRI conditions and MRI-specific warnings and precautions for conducting an MRI scan, refer to the MRI guidelines for Medtronic neurostimulation systems for chronic pain instructions for use manual. Package contents Neurostimulator Torque wrench Product literature Warranty card Registration form Patient identification card Patient identification card A patient identification card is packaged with this device. Advise the patient to carry the most up-to-date identification card at all times and to bring the card to all MRI appointments. 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, 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 sequentiallyfirst a pulse from one program, then a pulse from the next program. 977142016-06-01English7 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. Table 1. Operating values for the RestoreSensor SureScan MRI Model 97714 neurostimulator Programmable parameter 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 limitc Pulse width lower patient limitc Rate Rate upper patient limit Rate lower patient limit SoftStart/Stop Operating range and resolutiona 1 to 8b 1 to 4b 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 up to 10.5 V (same resolution as amplitude) Custom limit: 0 V to the programmed value (same resolution as amplitude) 60 to 1000 s (10-s resolution) Tracking limit: programmed value +0 to +300 s (60-s resolution) Custom limit: programmed value up to 1000 s (10-s resolution) Custom limit: 60 s to the programmed value (10-s 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)d 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 8English977142016-06-01 Table 1. Operating values for the RestoreSensor SureScan MRI Model 97714 Programmable parameter Cycling neurostimulator (continued) Operating range and resolutiona Off, On: 0.1 s to 30 min (resolution: 0.1 s from 0.1 s to 1 s; 1 s from 1 s to 1 min; 1 min from 1 min to 30 min) Off, On: 6 positions AdaptiveStim a Interlocks will prevent the use of some parameter combinations. b No more than 16 programs may be defined within the 8 groups. c Pulse width limit and rate limit are 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 are active. 977142016-06-01English9 Description Connector type Height Length Thickness case connector Table 2. Physical characteristics of the RestoreSensor SureScan MRI Model 97714 neurostimulatora Value Octapolar, in-line 2.8-mm (0.110-in) spacing 54.0 mm (2.1 in) 54.0 mm (2.1 in) 9.0 mm (0.4 in) 11.0 mm (0.4 in) 45.0 g (1.6 oz) 22.0 cm3 (1.34 in3) 9 years Lithium ion rechargeable battery 18 C to +52 C (0 F to +126 F) NMD NMA Weight Volume Battery life Power source Temperature limitation Serial number model designatorb Radiopaque identification (ID) codec 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. c The radiopaque ID code is located in the connector block; NMA indicates that the neurostimulator has SureScan MRI Technology. This radiopaque ID code is for confirming, if needed, that a SureScan MRI neurostimulator is implanted and is not to be used for concluding that the entire neurostimulation system is full-body MRI scan eligible. 10English977142016-06-01 Table 3. Material of components in the RestoreSensor SureScan MRI Model 97714 package Components Material Material contacts human tissue Neurostimulator Case Connector block Grommets, seals Setscrews Adhesive Torque wrench Handle Shaft Titanium Polysulfone, 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. 977142016-06-01English11 Implanted components and MRI scans Implant criteria for full-body MRI scan eligibility Caution: To allow a patient full-body MRI scan eligibility under specific conditions, implant a Medtronic neurostimulation system with SureScan MRI Technology as follows:
Use only SureScan MRI neurostimulation system components (eg, leads and neurostimulators). Note: Extension model numbers in the 3708 series (eg, 37081, 37082, 37083) are not full-body MRI scan eligible. Implant the neurostimulator in the buttocks, abdomen, or flank (ie, the lateral and Place the lead tip(s) in the spinal epidural space. Explant any previously abandoned pain leads or extensions that may be in the posterior region between the ribs and pelvis). patient (ie, leads or extensions, or portions of, that are not connected to a neurostimulator). Note: Confirm MRI compatibility of any other implanted medical devices. Other implanted medical devices may limit or restrict MRI scans. Enter all component model number and implant location information using the clinician programmer. If the above implant criteria are not met, the patient will not have a neurostimulation system with full-body MRI scan eligibility. MRI scan eligibility will be restricted. For the MRI conditions and MRI-specific warnings and precautions for conducting an MRI scan, refer to the MRI guidelines for Medtronic neurostimulation systems for chronic pain instructions for use manual. When changing components Warning: Before explanting and replacing an existing neurostimulator, print a report from the existing neurostimulator that shows implanted and any abandoned component information. When adding, changing, or removing neurostimulators, leads, extensions, and accessories, always program up-to-date component model numbers, implant locations, and any abandoned component information to re-establish MRI-
scan eligibility. If this information is not updated or is entered incorrectly, MRI scan-type eligibility data will be inaccurate, and the patient is at risk for one of the following:
The patient is allowed to have an MRI scan inappropriate for the implanted components, which could cause tissue heating, resulting in tissue damage or serious patient injury. The patient is unnecessarily restricted from having an MRI scan. 12English977142016-06-01 When explanting components Caution: If permanently explanting a neurostimulator, be sure to also explant all leads, extensions, and accessories. Abandoned components may prevent the patient from being allowed MRI scans in the future due to concerns of lead electrode heating that can result in tissue damage. Instructions for use Implanting physicians should be experienced in epidural-access procedures and should be thoroughly familiar with all product labeling. 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: Advise patients to charge the neurostimulator when a Low battery (
) 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 Battery function is not restored and the neurostimulator must be surgically because battery capacity has been reduced. 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. 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. 977142016-06-01English13 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.) 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 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. Unretracted setscrews may damage the extension or lead and prevent the extension or lead from fully seating into the connector block. 14English977142016-06-01 Socket II (Electrodes 8-15) Socket I (Electrodes 0-7) Extension or Lead 1 Extension or Lead 2 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. 4. For each extension, lead, or plug, fully insert the torque wrench 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. 977142016-06-01English15 Figure 2. Tightening the setscrews in the self-sealing grommet. Implanting the neurostimulator Warning: Do not enclose a neurostimulator with SureScan MRI Technology in a cover, such as those used to mitigate a titanium allergy. A neurostimulator cover may cause significant heating of the lead electrodes during an MRI scan, placing the patient at risk for tissue heating, resulting in tissue damage or serious patient injury. Warning: Do not tie ligatures directly around the lead body. Ligatures around the lead body can damage the lead body or conductor wires, resulting in a loss of therapy. During an MRI scan, the patient could be at risk of tissue heating, resulting in tissue damage or serious patient injury. Caution: To prevent device inversion, do not make the neurostimulator pocket any larger than necessary to fit the neurostimulator and excess lead or extension. Device inversion may result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site, requiring repeat surgery to restore therapy. Note: For full-body MRI scan eligibility, confirm that the subcutaneous pocket for the neurostimulator has been created in the buttocks, abdomen, or flank. (See the caution in
"Implant criteria for full-body MRI scan eligibility" on page 12.) 1. With the Medtronic logo facing outward, away from muscle tissue, rotate the neurostimulator counterclockwise to coil the excess lead or extension (Figure 3). Caution: Do not twist or kink the lead or extension bodies when rotating the neurostimulator and coiling the excess lead or extension. Twisting or kinking of the components creates a torsional load that may increase the risk of unwanted movement or damage to the neurostimulation system components. 16English977142016-06-01 Figure 3. Rotate counterclockwise to coil excess lead or extension length. 2. Insert the neurostimulator and excess lead or extension coils into the subcutaneous pocket with the Medtronic logo facing outward, away from muscle tissue. Ensure that the leads or extensions are not twisted or 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 outward. If implanted with the Medtronic logo facing inward, the neurostimulator will be difficult to charge. Do not coil excess extensions or leads in front of the neurostimulator. Wrap excess extensions or leads around the perimeter (Figure 4) 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 4. Wrap excess extensions or leads around the perimeter (or behind) the neurostimulator. 977142016-06-01English17 3. Use the suture holes in the connector block to secure the neurostimulator to the muscle fascia with nonabsorbable silk. Notes:
Secure the neurostimulator in the pocket to minimize movement or migration of the Suturing the neurostimulator also may prevent movement of the neurostimulator neurostimulator. from torque and other forces during an MRI scan. 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 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 a short or open circuit. If the system integrity test results are not acceptable, refer to "Connecting the extension or lead to the neurostimulator" on page 14. 2. 3. Complete the stimulation assessment form. Completing the implant procedure 1. Close and dress all incisions. 2. Ensure that a patient control device and a completed patient identification card are given to the patient. 3. Complete the device tracking and patient registration paperwork and return the documents to Medtronic. 18English977142016-06-01 977142016-06-01English19 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.
*M940100A007*
Medtronic, Inc. 2016 All Rights Reserved M940100A007 Rev A
1 | Manual Labeling Attestation Letter | ID Label/Location Info | 113.91 KiB |
Marchs 29, 2018 Equipment Authorization Branch Federal Communications Commission Columbia, MD 21046 Regarding: Application for certification for FCC id:
LF53058, LF53023, LF58637, LF597713, LF597714, LF537601, LF537602, LF537612 Gentlemen:
We are seeking a Non-Routine Request for permanent confidentiality for our internal photos exhibit, block diagram and electrical schematic. The reasons are for the immediate protection of patients and to protect intellectual property related to the implant internal hardware. In addition, we seek approval under Section 15 submission for labeling deviation. The FCC ID number associated with the transmitter and the information required by Section 2 of the FCC Rules will be placed in the instruction manual for the transmitter, in lieu of being placed directly on the transmitter. The device being implanted in the human body makes marking the device with supplemental information a manufacturing hardship and additional safety risks. If you have any questions regarding this application, please feel call me at 763-526-0652 or contact via email at guillaume.girard@medtornic.com Sincerely, Guillaume Girard Medtronic, Inc. Tel 763-526-0652 guillaume.girard@medtronic.coms
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2018-05-25 | 0.175 ~ 0.175 | DCD - Part 15 Low Power Transmitter Below 1705 kHz | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2018-05-25
|
||||
1 | Applicant's complete, legal business name |
Medtronic, Inc.
|
||||
1 | FCC Registration Number (FRN) |
0008250839
|
||||
1 | Physical Address |
8200 Coral Sea Street NE
|
||||
1 |
Mounds View, Minnesota 55112
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
t******@siemic.com
|
||||
1 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
LF5
|
||||
1 | Equipment Product Code |
97714
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
G******** G******
|
||||
1 | Title |
Sr. RF Regulatory Program Manager
|
||||
1 | Telephone Number |
763-5********
|
||||
1 | Fax Number |
651-3********
|
||||
1 |
G******@medtronic.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 11/21/2018 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DCD - Part 15 Low Power Transmitter Below 1705 kHz | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Restore Sensor SureScan MRI | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Bureau Veritas Consumer Products Services, Inc.
|
||||
1 | Name |
L******** B******
|
||||
1 | Telephone Number |
408-5********
|
||||
1 | Fax Number |
408 5********
|
||||
1 |
l******@siemic.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | IT | 0.17500000 | 0.17500000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC