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1 | Regulatory Statements | Users Manual | 593.13 KiB |
3058 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 M969810A002 Rev A Communications Regulations The following is a list of communications regulations that apply to the Model 3058. United States Compliance FCC ID: LF53058 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. Canada Compliance IC: CANADA310 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 1083-16-5567 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-302358 This radio device has possibility of radio interference during operation.
*M969810A002*
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-20908 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 3058 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
, 3058 2014/53/.
:
www.MedtronicCompliance.eu 175 kHz H 30 dBA/m 10 . Czech Spolenost Medtronic tmto prohlauje, e toto radiov zazen, slo modelu 3058, 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 3058 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. 3058 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 3058 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 3058 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 3058 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 3058, 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 3058 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 3058 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 3058 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 3058 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 3058, 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 3058, 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 3058 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 3058, 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 3058, 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 3058 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 3058, 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 3058, 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 3058 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 3058 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 | 614.93 KiB |
InterStim Therapy InterStim II Model 3058 Neurostimulator InterStim Model 3023 Neurostimulator 3058 3023 Implant manual Rx only 2006 (3058) 1995 (3023) Explanation of symbols on product or package labeling Open here Do not reuse STERILE EO Sterilized using ethylene oxide Use by Serial number Do not use if package is damaged Conformit Europenne (European Conformity). This symbol means that the device fully complies with AIMD Directive 90/385/EEC
(NB 0123). Date of Manufacture Consult instructions for use 2 STERILIZE XX C XXX F
-XX C
-XX F Do not resterilize Temperature limitation Manufacturer EC REP Authorized representative in the Europe2016an community For USA audiences only InterStim Therapy 2016-06-01 English 1 Medtronic, InterStim, and SoftStart/Stop are trademarks of Medtronic, Inc., registered in the U.S. and other countries. 2 English 2016-06-01 InterStim Therapy Table of contents Introduction 5 Device description 5 Package contents 5 Patient registration and identification card 5 Device specifications 5 X-Ray identification 8 Instructions for use: Model 3058 9 Verifying neurostimulator operation 9 Creating a pocket for the Model 3058 Neurostimulator 9 Connecting the lead to the Model 3058 Neurostimulator 10 Implanting the Model 3058 Neurostimulator 13 Completing the implant procedure 14 Replacing the Model 3058 Neurostimulator 14 Device description 15 Package contents 15 Patient registration and identification card 15 Device specifications 15 X-Ray identification 18 Instructions for use: Model 3023 19 Verifying neurostimulator operation 19 Creating a pocket for the Model 3023 Neurostimulator 19 Connecting the extension to the Model 3023 Neurostimulator 20 Refer to the appropriate Information for Prescribers (IFP) booklet for contraindications, warnings, precautions, adverse events summary, individualization of treatment, patient selection, use in specific populations, resterilization, and component disposal. Refer to the Indications Insert for indications and related information. Refer to the System Overview and Compatibility Insert for information regarding device compatibility. InterStim Therapy and for a complete summary of adverse events. Note: Some product models described in this manual may not be available in all geographies. Refer to the Clinical Summary for information on the clinical study results for Refer to the Limited Warranty and Special Notice Insert for warranty information. Refer to the System Eligibility, Battery Longevity, Specifications reference manual for neurostimulator selection, battery longevity calculations, and specific neurostimulator specifications. InterStim Therapy 2016-06-01 English 3 Implanting the Model 3023 Neurostimulator 23 Completing the implant procedure 24 Replacing the Model 3023 Neurostimulator 24 Declaration of conformity 25 Control magnet 26 4 English 2016-06-01 InterStim Therapy InterStim II Model 3058 Neurostimulator Introduction This manual includes information about two devices used separately as part of a Medtronic InterStim System. The Medtronic InterStim II Model 3058 Neurostimulator is used with a lead and the Medtronic InterStim Model 3023 Neurostimulator is used with a lead and an extension. InterStim II Model 3058 Neurostimulator Device description The Medtronic InterStim II Model 3058 Neurostimulator is part of a neurostimulation system for InterStim Therapy. Package contents
Neurostimulator
Torque wrench
Product literature Patient registration and identification card The implant registration form registers the device and creates a record of the device in Medtronics implant data system. A patient identification card is package with this device. Advise the patient to carry the identification card at all times. The patient identification card packaged with the device is temporary; a permanent card will be mailed to the patient when Medtronic receives the implant registration form. Device specifications The neurostimulator is a programmable device that accommodates a lead through which a stimulation program is delivered. Refer to Table 1 for shipping, operating, and power-on-reset values. Refer to Table 2 for physical characteristics. Refer to Table 3 for materials of package components. InterStim Therapy 2016-06-01 English 5 InterStim II Model 3058 Neurostimulator Table 1. Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulatora. Programmable Parameters Amplitude Normal Resolution Upper Limit Lower Limit Fine Resolution Upper Limit Lower Limit Rate Pulse width Operating Mode Cycle On/Cycle Off timec SoftStart/Stopd Shipping Operating 0.0 V 0.0 V 0.0 V
---
---
---
14 Hz 210 s 100 mV steps 8.5 V maximum 0.0 V minimum 50 mV steps 6.35 V maximum 0.0 V minimum 49 values
(from 2.1 to 130 Hz) Increments of 30 s steps 450 s maximum 60 s minimum Continuous Continuous or Cycling 0.1 sec Off 0.1 sec to 24 hr 1, 2, 4, 8, 15, 30 sec, or Off On or Off Output On/Off Polarity Off Off Off
+
Off Electrode Number 0 1 2 3 Casee Off, + or Off, + or Off, + or Off, + or Off or +
PORb 0.0 V 0.0 V 0.0 V
---
---
---
31 Hz 210 s Continuous 0.1 sec Off Off Off Off
+
Off a All values are approximate. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. POR can occur when there is a temporary fluctuation in battery voltage (eg, due to electromagnetic interference during electrocautery or defibrillation) or the battery is depleted. When POR occurs, the serial number is reset to a nominal value and must be entered with the clinician programmer. c Cycle On and Cycle Off time must be greater than or equal to the SoftStart/Stop time. d SoftStart/Stop must be less than or equal to the Cycle On and Cycle Off time. e If case electrode is positive, electrodes 0-3 may be programmed to Off or only. 6 English 2016-06-01 InterStim Therapy Table 2. Physical characteristics of the InterStim II Model 3058 Neurostimulator.a InterStim II Model 3058 Neurostimulator Description Height Length Thickness Weight Volume External shield Power sourceb Storage temperature Serial Numberc Radiopaque Identification
(ID)
(1.7 in)
(2 in)
(0.3 in)
(0.77 oz)
(0.85 in3) Value 44 mm 51 mm 7.7 mm 22 g 14 cm3 Titanium 1.3 Amp Hours, 3.2 V Lithium silver vanadium oxide hybrid
-18 C to 52 C (0 F to 125 F) NJY a All measurements are approximate. b The power source is hermetically sealed within the case. c The serial number is the radiopaque ID followed by a number. The clinician programmer displays the entire number beginning with the radiopaque ID. InterStim Therapy 2016-06-01 English 7 InterStim II Model 3058 Neurostimulator X-Ray identification Radiopaque identification permits the determination of manufacturer and neurostimulator model number (Figure 1). With standard x-ray procedures, the code appears as black characters on white background. The Medtronic symbol identifies Medtronic as the manufacturer. For the Medtronic InterStim II Model 3058 Neurostimulator, the designated characters are NJY. Figure 1. The InterStim II Model 3058 Neurostimulator radiopaque code block. Table 3. Material of components in the Model 3058 package. Structure Casea Connector Grommets, seals, strain relief Setscrew and electrical contacts Adhesive Torque wrench Handle Shaft Material Titanium Urethane Silicone rubber Material Contacts Human Tissue Yes Yes Yes Titanium Silicone adhesive Polyetherimide Stainless steel Yes Yes Yes Yes a The electronics and power source are hermetically sealed within the case. 8 English 2016-06-01 InterStim Therapy Instructions for use: Model 3058 InterStim II Model 3058 Neurostimulator Cautions:
When using sharp instruments near the neurostimulator, be 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, use the clinician programmer to interrogate the neurostimulator and verify neurostimulator battery status and current settings. 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. Creating a pocket for the Model 3058 Neurostimulator 1. Create a subcutaneous pocket for the neurostimulator by blunt dissection to the anterior surface of the muscle. The neurostimulator is placed in the upper buttock area. Notes:
The Model 3058 Neurostimulator should be placed no deeper than 2.5 cm (1 in) below the skin and should be parallel to the skin. If the neurostimulator is too deep or is not parallel to the skin, telemetry may be unsuccessful. If the patient has any other neurostimulator, the neurostimulators must be separated by a minimum of 20 cm (8 in).
Cautions:
The neurostimulator is provided sterile. Do not soak the neurostimulator in antibiotic solution. Soaking in antibiotic solution can affect lead connections.
To avoid infection, it is recommended that the neurostimulator implant site be irrigated with antibiotic solution, and that IV antibiotics be administered perioperatively. Do not allow the neurostimulator to come into contact with any non-sterile surface. Do not place on skin. If an infection occurs, it may require surgical removal of the implanted system. 2. Place the neurostimulator in the pocket to assure proper fit and then remove it. Keep the neurostimulator sterile and clean. 3. Tunnel from the lead incision site to the neurostimulator pocket. Refer to the product literature packaged with the lead for detailed tunneling and lead implant instructions. InterStim Therapy 2016-06-01 English 9 InterStim II Model 3058 Neurostimulator 4. Connect the lead to the Model 3058 Neurostimulator according to the steps in Connecting the lead to the Model 3058 Neurostimulator in this manual. Connecting the lead to the Model 3058 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 proximal lead electrode connections with sterile gauze. If necessary, use sterile (United States Pharmacopeia [USP]) water or a nonionic antibiotic solution, then wipe dry. 2. Make sure the connector block receptacle is dry and clean. 3. Confirm that the lead has four electrodes matching the encapsulated diagram on the neurostimulator (Figure 2). Insert the lead into the neurostimulator connector block until fully seated (Figure 2). Caution: Do not pull the lead body taut when implanted. The lead is available in different lengths. Select a lead length that allows connection without tension. 4. Note: To retract the setscrew, insert the torque wrench into the self-sealing grommet and rotate the setscrew counterclockwise; however, do not remove the setscrew from the connector block (Figure 3). Caution: Do not insert the lead into the connector block if the setscrew is not sufficiently retracted. If the setscrew is not retracted, the lead may damage the setscrew and the lead then will not seat fully into the connector block. 10 English 2016-06-01 InterStim Therapy InterStim II Model 3058 Neurostimulator Encapsulated Diagram Figure 2. Insert lead fully into Model 3058 Neurostimulator connector block. Figure 3. To back out the setscrew from the Model 3058 Neurostimulator, use the torque wrench and turn setscrew counterclockwise. Note: The torque wrench must be oriented to the same angle as the setscrew
(Figure 3). InterStim Therapy 2016-06-01 English 11 InterStim II Model 3058 Neurostimulator 5. Fully insert the torque wrench into the self-sealing grommet of the connector block and tighten the setscrew by turning clockwise until the torque wrench clicks (Figure 4). 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 the setscrew, ensure that the lead is inserted into the connector block to prevent damaging the connector block.
Verify that 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 may occur.
Discard the torque wrench after making the connection. The torque wrench is single-use-only. Its operation cannot be assured if it is used for multiple surgeries. Figure 4. Tighten the setscrew in the self-sealing grommet by turning clockwise until the torque wrench clicks. Note: The torque wrench must be oriented to the same angle as the setscrew
(Figure 4). 12 English 2016-06-01 InterStim Therapy InterStim II Model 3058 Neurostimulator Implanting the Model 3058 Neurostimulator 1. Place the neurostimulator into the subcutaneous pocket with the etched identification side placed outward, away from muscle tissue, and ensure that the lead is not bent sharply. Note: The Model 3058 Neurostimulator should be placed no deeper than 2.5 cm (1 in) below the skin and should be parallel to the skin. If the neurostimulator is too deep or is not parallel to the skin, telemetry may be unsuccessful. Caution: Do not coil excess length in front of the etched identification side of the neurostimulator. Wrap excess length around the perimeter of the neurostimulator
(Figure 5) to avoid increasing subcutaneous pocket depth, help minimize potential damage during neurostimulator replacement surgery, help minimize potential kinking, and minimize interference with telemetry during programming. Figure 5. Wrap excess length around perimeter of the Model 3058 Neurostimulator. 2. Check the system integrity before securing the neurostimulator in place. a. Use the clinician programmer and the product literature packaged with it to confirm the integrity of the connected system. 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 to ensure proper readings. b. Program the stimulation parameters you have selected for your patient according to the product literature packaged with the programmer. c. Check the battery status; if applicable, check the electrode impedances to rule out a short or open circuit. InterStim Therapy 2016-06-01 English 13 InterStim II Model 3058 Neurostimulator 3. Use the two suture holes in the connector block to secure the neurostimulator to the muscle fascia with nonabsorbable silk. Completing the implant procedure 1. Close and dress all incisions. 2. Ensure that a patient programmer and a patient ID card are given to the patient. Caution: Because the patient programmer is the patients only means to adjust or turn the neurostimulator on or off, the patient must carry a programmer at all times. 3. Complete the device tracking and patient registration paperwork and return the documents to Medtronic. Note: See the Information for Prescribers booklet packaged with this device for clinician instructions to patients and for information regarding the return of product documentation. 4. Schedule regular patient follow-up appointments to monitor the condition of the neurostimulator and to confirm that the programmed parameter values are appropriate. Replacing the Model 3058 Neurostimulator If replacing a Model 3023 Neurostimulator, refer to page 24 of this manual. 1. Open the implant site using normal surgical procedure and carefully remove the neurostimulator from the subcutaneous pocket. 2. Clean the neurostimulator connector block and lead with sterile water; wipe dry with sterile gauze. Insert a torque wrench through the prepierced hole in the rubber sealing grommet and loosen the setscrew by turning it counterclockwise. 3. 4. Gently retract the lead from the neurostimulator connector block. Caution: Replace any device that shows signs of damage, pitting, or corrosion. 5. Clean and dry the connector block and lead which must be free of fluids or tissue. 6. Set aside the explanted components for return to Medtronic. 7. Connect the lead and replacement neurostimulator according to the product literature packaged with those devices. Note: Increased pocket size may be necessary if replacement neurostimulator uses an extension. 8. Return explanted devices to Medtronic according to product literature packaged with those devices. 14 English 2016-06-01 InterStim Therapy InterStim Model 3023 Neurostimulator InterStim Model 3023 Neurostimulator Device description The Medtronic InterStim Model 3023 Neurostimulator is part of a neurostimulation system for InterStim Therapy. Package contents
Neurostimulator
Torque wrench
Product literature Patient registration and identification card The implant registration form registers the device and creates a record of the device in Medtronics implant data system. A patient identification card is packaged with this device. Advise the patient to carry the identification card at all times. The patient identification card packaged with the device is temporary; a permanent card will be mailed to the patient when Medtronic receives the implant registration form. Device specifications The neurostimulator is a programmable device that accommodates an extension by which a stimulation program is delivered through a lead. Refer to Table 4 for shipping, operating, and power-on-reset values. Refer to Table 5 for physical characteristics. Refer to Table 6 for materials of package components. InterStim Therapy 2016-06-01 English 15 InterStim Model 3023 Neurostimulator Table 4. Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim Model 3023 Neurostimulatora. Programmable Parameters Amplitude Normal Resolution Upper Limit Lower Limit Fine Resolution Upper Limit Lower Limit Rate Pulse Width Operating Mode Cycle On/Cycle Off timec SoftStart/Stopd Magnet Control Output On/Off Polarity Electrode Number 0 1 2 3 Casee Shipping Operating 0.0 V 0.0 V 0.0 V
---
---
---
14 Hz 210 s 100 mV steps 10.5 V maximum 0.0 V minimum 50 mV steps 6.35 V maximum 0.0 V minimum 49 values
(from 2.1 to 130 Hz) Increments of 30 s steps 450 s maximum 60 s minimum PORb 0.0 V 0.0 V 0.0 V
---
---
---
31 Hz 210 s Continuous Continuous or Cycling Continuous 0.1 sec Off Disabled Off Polarity Off Off
+
Off 0.1 sec to 24 hr 1, 2, 4, 8, 15, 30 sec, or Off Enabled/Disabled On or Off 0.1 sec Off Enabled Off Off, + or Off, + or Off, + or Off, + or Off or +
Off Off
+
Off a All values are approximate. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. POR can occur when there is a temporary fluctuation in battery voltage
(eg, due to electromagnetic interference during electrocautery or defibrillation) or the battery is depleted. When POR occurs, the serial number is reset to a nominal value and must be entered with the clinician programmer. c Cycle On and Cycle Off time must be greater than or equal to the SoftStart/Stop time. d SoftStart/Stop must be less than or equal to the Cycle On and Cycle Off time. e If case electrode is positive, electrodes 0-3 may be programmed to Off or only. 16 English InterStim Therapy 2016-06-01 Table 5. Physical characteristics of the InterStim Model 3023 Neurostimulatora. InterStim Model 3023 Neurostimulator Description Height Length Thickness Weight Volume External shield Power sourceb Storage temperature Serial Numberc Radiopaque Identification (ID)
(2.2 in)
(2.4 in)
(0.4 in)
(1.5 oz)
(1.5 in3) Value 55 mm 60 mm 10 mm 42 g 25 cm3 Titanium 2.7 Amp hours, 3.7 V Lithium-thionyl chloride cell
-18 C to 52 C (-0 F to 125 F) NBV a All measurements are approximate. b The power source is hermetically sealed within the case. c The serial number is the radiopaque ID followed by a number. The clinician programmer displays the entire number beginning with the radiopaque ID. InterStim Therapy 2016-06-01 English 17 InterStim Model 3023 Neurostimulator X-Ray identification Radiopaque identification permits the determination of manufacturer and neurostimulator model number (Figure 6). With standard x-ray procedures, the code appears as black characters on white background. The Medtronic symbol identifies Medtronic as the manufacturer. For the InterStim Model 3023 Neurostimulator, the designated characters are NBV. Material Figure 6. The InterStim Model 3023 Neurostimulator radiopaque code block. Table 6. Material of components in the Model 3023 package. Material Contacts Human Tissue Yes Titanium Yes Urethane Yes Silicone rubber Titanium Yes Polymeric insulating film Yes Structure Casea Connector Grommets, seals Setscrews Insulation coatingb Adhesive Torque wrench Handle Shaft Silicone adhesive Polyetherimide Stainless steel Yes Yes Yes a The electronics and power source are hermetically sealed within the case. b The etched side of the Model 3023 case is uninsulated and can be programmed as an indifferent electrode. 18 English 2016-06-01 InterStim Therapy Instructions for use: Model 3023 InterStim Model 3023 Neurostimulator Cautions:
When using sharp instruments near the neurostimulator, be 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. Verifying neurostimulator operation Before opening the sterile neurostimulator package, use the clinician programmer to interrogate the neurostimulator and verify neurostimulator battery status and current settings. 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. Creating a pocket for the Model 3023 Neurostimulator 1. Create a subcutaneous pocket for the neurostimulator by blunt dissection to the anterior surface of the muscle. The neurostimulator is typically placed in the upper buttock area. Notes:
Abdominal placement is an option with the Model 3023 Neurostimulator. Abdominal implant instructions are included in the product literature packaged with the leads.
The Model 3023 Neurostimulator should be placed no deeper than 4 cm (1.5 in) below the skin and should be parallel to the skin. If the neurostimulator is too deep or is not parallel to the skin, telemetry may be unsuccessful.
The uncoated, etched side of the 3023 case can be programmed as an indifferent electrode. The etched side of the neurostimulator must face away from muscle to prevent uncomfortable stimulation. If the patient has any other neurostimulator, the neurostimulators must be separated by a minimum 20 cm (8 in).
The Model 3023 Neurostimulator requires the use of an extension. InterStim Therapy 2016-06-01 English 19 InterStim Model 3023 Neurostimulator Cautions:
The neurostimulator is provided sterile. Do not soak the neurostimulator in antibiotic solution. Soaking in antibiotic solution can affect lead connections.
To avoid infection, it is recommended that the neurostimulator implant site be irrigated with antibiotic solution, and that IV antibiotics be administered perioperatively. Do not allow the neurostimulator to come into contact with any non-sterile surface. Do not place on skin. If an infection occurs, it may require surgical removal of the implanted system. 2. Place the neurostimulator in the pocket to assure proper fit and then remove it. Keep the neurostimulator sterile and clean. 3. Tunnel from the lead incision site to the neurostimulator pocket. Refer to the product literature packaged with the lead for detailed tunneling and lead implant instructions. 4. Wipe the proximal end of the lead with sterile gauze and make sure the extension is dry and clean. 5. Connect and implant the lead and extension according to product literature packaged with those devices. 6. Connect the extension to the Model 3023 Neurostimulator according to the steps in Connecting the extension to the Model 3023 Neurostimulator in this manual. Connecting the extension to the Model 3023 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 connector pins with sterile gauze. If necessary, use sterile (United States Pharmacopeia [USP]) water or a nonionic antibiotic solution, then wipe dry. 2. Make sure the connector block receptacles are dry and clean. 3. Confirm that the encapsulated diagram on the extension has four electrodes matching the encapsulated diagram on the neurostimulator (Figure 7). Insert the extension connector pins into the neurostimulator until they are fully seated within the connector block (Figure 7). 4. Caution: Do not pull the extension or lead body taut when implanted. The extension and lead are available in different lengths. Select a length that allows connection without tension. Note: 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 (Figure 8). 20 English 2016-06-01 InterStim Therapy InterStim Model 3023 Neurostimulator Caution: Do not insert the extension connector pins into the connector block if the setscrews are not sufficiently retracted. If the setscrews are not retracted, the extension connector pins may damage the setscrews and the extension connector pins will not be seated fully into the connector block. Encapsulated Diagram Figure 7. Insert extension connector pins fully into Model 3023 Neurostimulator connector block. Grommet Figure 8. To back out a setscrew from the Model 3023 Neurostimulator, use the torque wrench and turn the setscrew counterclockwise. Note: The torque wrench must be oriented to the same angle as the setscrew (Figure 8). InterStim Therapy 2016-06-01 English 21 InterStim Model 3023 Neurostimulator 5. Fully insert the torque wrench into the self-sealing grommet of the connector block and tighten each setscrew by turning clockwise until the torque wrench clicks (Figure 9). 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 connector pins are inserted into the connector block to prevent damaging the connector block.
Verify that each 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 may occur.
Discard the torque wrench after making all of the connections. The torque wrench is single-use-only. Its operation cannot be assured if it is used for multiple surgeries. Figure 9. Tighten the setscrews in the self-sealing grommet by turning clockwise until the torque wrench clicks. Note: The torque wrench must be oriented to the same angle as the setscrew
(Figure 9). 22 English 2016-06-01 InterStim Therapy InterStim Model 3023 Neurostimulator Implanting the Model 3023 Neurostimulator 1. Place the neurostimulator into the subcutaneous pocket with the etched identification side placed outward, away from muscle tissue, and ensure that the extension is not bent sharply. Note: The Model 3023 Neurostimulator should be placed no deeper than 4 cm (1.5 in) below the skin and should be parallel to the skin. If the neurostimulator is too deep or is not parallel to the skin, telemetry may be unsuccessful. Cautions:
Do not place the etched identification side of the neurostimulator facing inward. Placing the etched side inward could increase the possibility of skeletomuscular stimulation, which the patient may perceive as twitching or burning.
Do not coil excess length in front of the etched identification side of the neurostimulator. Wrap excess length around the perimeter of the neurostimulator (Figure 10) to avoid increasing subcutaneous pocket depth, help minimize potential damage during neurostimulator replacement surgery, help minimize potential kinking, and minimize interference with telemetry during programming. Figure 10. Wrap excess extension around the perimeter of the Model 3023 Neurostimulator. 2. Check the system integrity before securing the neurostimulator in place. a. Use the clinician programmer and the product literature packaged with it to confirm the integrity of the connected system. InterStim Therapy 2016-06-01 English 23 InterStim Model 3023 Neurostimulator 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 to ensure proper readings. b. Program the stimulation parameters you have selected for your patient according to product literature packaged with the programmer. c. Check the battery status; if applicable, check the electrode impedances to rule out a short or open circuit. 3. Use the two suture holes in the connector block to secure the neurostimulator to the muscle fascia with nonabsorbable silk. Completing the implant procedure 1. Close and dress all incisions. 2. Ensure that a patient programmer and a patient ID card are given to the patient. Caution: Because the patient programmer is used to adjust or turn the neurostimulator on or off, the patient must carry a programmer at all times. Patients implanted with a Model 3023 Neurostimulator may also receive the optional Model 7452 Control Magnet that is used to turn the neurostimulator on or off. In order for the control magnet to turn the neurostimulator on or off, the clinician must enable Magnet Control on the Model 3023 Neurostimulator using the clinician programmer. Magnet Control can not be enabled or disabled using the patient programmer. 3. Complete the device tracking and patient registration paperwork and return the documents to Medtronic. Note: See the Information for Prescribers booklet packaged with this device for clinician instructions to patients and for information regarding the return of product documentation. 4. Schedule regular patient follow-up appointments to monitor the condition of the neurostimulator and to confirm that the programmed parameter values are appropriate. Replacing the Model 3023 Neurostimulator If replacing a Model 3058 Neurostimulator, refer to page 14 of this manual. 1. Open the implant site using normal surgical procedure and carefully remove the neurostimulator from the subcutaneous pocket. 2. Clean the neurostimulator connector block and extension connector with sterile water;
wipe lead dry with surgical sponges. 24 English 2016-06-01 InterStim Therapy 3. InterStim Model 3023 Neurostimulator Insert a torque wrench through each prepierced hole in the rubber sealing grommet and loosen the setscrews by turning them counterclockwise. 4. Gently retract the extension connector pins from the neurostimulator connector block. Caution: Replace any device that shows signs of damage, pitting, or corrosion. 5. Clean and dry the connector block and extension connector pins which must be free of fluids or tissue. Note: If the replacement neurostimulator does not require the existing extension, disconnect the extension from the lead. Clean and dry the proximal end of the lead. Take care not to move the lead when extension is disconnected. 6. Set aside the explanted components for return to Medtronic. 7. Connect the replacement neurostimulator according to the product literature packaged with that device. 8. Return explanted devices to Medtronic according to product literature packaged with those devices. Declaration of conformity Medtronic declares that the Model 3058 and Model 3023 Neurostimulators are in conformity with the essential requirements of Directive 90/385/EEC on Active Implantable Medical Devices. For additional information, contact the appropriate Medtronic office listed on the inside back cover of this manual. InterStim Therapy 2016-06-01 English 25 InterStim Model 3023 Neurostimulator Control magnet The Medtronic Model 7452 Control Magnet allows your patient to turn the Model 3023 Neurostimulator on or off. The control magnet is not used with the Model 3058 Neurostimulator. When the control magnet on/off control circuit is enabled, applying the flat, rectangular edge of the control magnet over the implant site for 1 to 2 seconds (Figure 11) and then removing it turns the neurostimulator on or off. Neurostimulator Control Magnet Figure 11. Control magnet properly positioned over the Model 3023 Neurostimulator. If SoftStart/Stop is in use, turning the Model 3023 Neurostimulator on causes the amplitude to ramp up from zero to the selected output amplitude. Turning the neurostimulator off causes the amplitude to ramp down to zero again. The ramp time is set by the SoftStart/
Stop parameters. The control magnet on/off control circuit does not affect programmed parameters; when the output is turned on with the control magnet, the output resumes its previously programmed waveform and stimulation mode. For patients who live or work in electrically noisy environments, random on or off switching may be a problem. If on or off switching occurs, you can disable the magnet control circuitry with a command to the neurostimulator from the clinician programmer. Detailed instructions on disabling this feature are provided in the product literature packaged with the programmer software. Note: The patient with a Model 3023 Neurostimulator may carry the optional control magnet to turn the neurostimulator on or off. The patient programmer will still operate the neurostimulator because it uses a different circuit than the control magnet to turn the neurostimulator on or off. The magnet control circuit can be enabled again with another command from the clinician programmer, if desired. 26 English 2016-06-01 InterStim Therapy InterStim Model 3023 Neurostimulator Caution: Because the patient programmer is used to adjust or turn on or off the neurostimulator, the patient must carry a programmer at all times. Patients implanted with a Model 3023 Neurostimulator may also receive the optional Model 7452 Control Magnet that is used to turn the neurostimulator on or off. In order for the control magnet to turn the neurostimulator on or off, the clinician must enable Magnet Control on the Model 3023 Neurostimulator using the clinician programmer. Magnet Control can not be enabled or disabled using the patient programmer. InterStim Therapy 2016-06-01 English 27 Contacts:
Asia: Medtronic International Ltd. Tel. 02919-1362 Fax 02907-3998 Asia: 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 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. (1905) 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. 03-6430-2016 Fax 03-6430-7110 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.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 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 (1800) 328-0810 EC REP 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 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. 852-2919-1362 Fax 852-2907-3998 Contacts for specific countries are listed inside this cover.
*MA12231A024*
Medtronic, Inc. 2016 All Rights Reserved MA12231A024 Rev A
1 | Manual Labeling Attestation Letter | ID Label/Location Info | 50.76 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, 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 |
3058
|
||||
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) | InterStim II | ||||
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