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Users Manual - Regulatory Statements | Users Manual | 678.32 KiB | ||||
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1 2 | Block diagram | Block Diagram | November 21 2017 | confidential | ||||
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1 2 | Operational description | Operational Description | November 21 2017 | confidential | ||||
1 2 | Schematic diagram | Schematics | November 21 2017 | confidential | ||||
1 2 | Test Report | |||||||
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1 2 | Users Manual - Regulatory Statements | Users Manual | 678.32 KiB |
Filename Date Time UC200xxxxxx EN 22.9 x 10.6 inches (582 mm x 269 mm) TM90 Communications Regulation Reference Sheet Fold 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. 2018 All Rights Reserved M971971A001 Rev A
*M971971A001*
2018-01-01 M971971A001 Rev A Fold Fold Fold Fold Fold Fold Fold Fold Medtronic Confidential IFUHybridLarge.xsl - IFUHybridManualLarge.fm Template version 6.2: 06-14-2017 Communications Regulations The following is a list of communications regulations that apply to the Model TM90. United States Compliance FCC ID: LF5TM90 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: 3408D-TM90 This device complies with Industry Canada license-
exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le prsent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et
(2) l'appareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible d'en compromettre le fonctionnement. Argentina Compliance CNC ID: H-20181 This product conforms to Argentina Radio Requirements. Este producto cumple los requisitos de Argentina relativos a la radioelectricidad. Korea Compliance MSIP-CRI-MKL-TM90 This radio device has possibility of radio interference during operation. Singapore Compliance Dealer License # DA103452 This product complies with IDA Standards.
IDA
HIDF15000146 Malaysia Compliance HIDF15000146 This product conforms to Malaysia Radio Requirement. Produk ini mematuhi Keperluan Radio Malaysia. Japan Compliance R: 201-170676 This product conforms to Japan Radio Law Requirements. Australia and New Zealand Compliance This product conforms to Australia and New Zealand Radio Requirements. European Union Compliance Conformit Europenne
(European Conformity) Hereby, Medtronic declares that this Radio Equipment Model number TM90 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 the following frequencies:
175 kHz with an H-field strength of less than 30 dBA/m at 10 m 2,4-2,4835 GHz-bnd med en RF-udgangseffekt p mindre end 10 mW e.i.r.p. Bulgarian Medtronic
, TM90 2014/53/.
:
www.MedtronicCompliance.eu
:
175 kHz H 30 dBA/m 10 2,4-2,4835 GHz 10 mW e.i.r.p. Czech Spolenost Medtronic tmto prohlauje, e toto radiov zazen, slo modelu TM90, 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 nsledujc frekvence:
175 kHz, piem intenzita pole H je ni ne 30 dBA/m ve vzdlenosti 10 m frekvenn psmo 402-405 MHz, piem efektivn vyzaovan vkon je ni ne 25 W ERP frekvenn psmo 2,4-2,4835 GHz, piem vstupn RF vkon je ni ne 10 mW EIRP Danish Medtronic erklrer hermed, at dette radioudstyr modelnummer TM90 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 flgende frekvenser:
175 kHz med en H-feltstyrke p mindre end 30 dBA/m ved 10 m 2,4-2,4835 GHz-bnd med en RF-udgangseffekt p mindre end 10 mW e.i.r.p. German Hiermit erklrt Medtronic, dass dieses Funkgertmodell Nr. TM90 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 den folgenden Frequenzen:
175 kHz mit einer H-
Feldstrke von weniger als 30 dBA/m in einer Entfernung von 10 m 2,4-2,4835-GHz-Band mit einer HF-Ausgangsleistung von weniger als 10 mW EIRP Greek
, Medtronic M TM90 O 2014/53/E.
:
www.MedtronicCompliance.eu
:
175 kHz H 30 dBA/m 10 m 2,4-2,4835 GHz
(RF) 10 mW e.i.r.p. (
) Spanish Por la presente, Medtronic declara que este equipo de radio, modelo nmero TM90 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 en las siguientes frecuencias:
175 kHz con una intensidad de campo H de menos de 30 dBA/m a 10 m Banda de frecuencia de 2,4-2,4835 GHz con una potencia de salida de RF
(PIRE) de menos de 10 mW Estonian Kesolevaga kinnitab Medtronic, et see raadioseadmestik mudelinumbriga TM90 on vastavuses direktiiviga 2014/53/EL. Kogu EL-i vastavusdeklaratsiooni tekst on saadaval jrgmisel internetiaadressil:
www.MedtronicCompliance.eu See toode ttab jrgmistel sagedustel. 175 kHz H-vlja tugevusega vhem kui 30 dBA/m 10 m juures 2,4-2,4835 GHz ribalaiusel raadiosagedusliku vljundvimsusega vhem kui 10 mW e.i.r.p. Finnish Medtronic vakuuttaa tten, ett tm radiolaite, mallinumero TM90, vastaa direktiivi 2014/53/EU. EU-
vaatimustenmukaisuus-
vakuutuksen koko teksti on saatavissa seuraavasta Internet-osoitteesta:
www.MedtronicCompliance.eu Tm tuote toimii seuraavilla taajuuksilla:
175 kHz, H-kentn voimakkuus alle 30 dBA/m 10 m:n etisyydell 2,4-2,4835 GHz:n kaista, RF-
lhtteho alle 10 mW EIRP French Par la prsente, Medtronic dclare que cet quipement radio Modle TM90 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 aux frquences suivantes:
175 kHz avec une intensit de champ H infrieure 30 dBA/m 10 m dans la bande de 2,4-2,4835 GHz avec une puissance de sortie RF infrieure 10 mW PIRE Croatian Ovime tvrtka Medtronic izjavljuje da je ova radijska oprema model TM90 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 sljedeim frekvencijama:
175 kHz sa snagom H polja manjom od 30 dBA/m pri 10 m pri frekvenciji od 2,4-2,4835 GHz s izlaznom RF snagom manjom od 10 mW e.i.r.p Hungarian A Medtronic ezton nyilatkozza, hogy ez az TM90 tpusszm rdiberendezs megfelel a 2014/53/EU irnyelvnek. Az EU megfelelsgi nyilatkozat teljes szvege elrhet a kvetkez internetes cmen:
www.MedtronicCompliance.eu A termk a kvetkez frekvencikon zemel:
175 kHz, mely esetben mgneses trerssge 10 m tvolsgban kevesebb, mint 30 dBA/m. 2,4-2,4835 GHz-es sv, mely esetben RF kimeneti teljestmnye kevesebb, mint 10 mW EIRP. Italian Con il presente documento, Medtronic dichiara che la presente apparecchiatura radio modello TM90 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 alle seguenti frequenze:
175 kHz con intensit di campo H inferiore a 30 dBA/m a 10 m Banda a 2,4-2,4835 GHz con potenza di uscita RF inferiore a 10 mW EIRP Lithuanian iuo Medtronic deklaruoja, kad is radijo rangos modelis, kurio numeris TM90, atitinka Direktyv 2014/53/EB. Vis ES atitikties deklaracijos tekst galite rasti iuo interneto adresu:
www.MedtronicCompliance.eu is gaminys veikia tokiais daniais:
175 kHz daniu, kai H lauko stiprumas yra maesnis nei 30 dBA/m 10 m atstumu. 2,4-2,4835 GHz danio diapazonas, RD ivesties galia yra maesn nei 10 mW EIRP. Latvian Ar o uzmums Medtronic apliecina, ka radioiekrta, modea numurs TM90, atbilst Direktvas 2014/53/ES prasbm. Pilnu ES atbilstbas deklarcijas tekstu var skatt vietn www.MedtronicCompliance.eu is izstrdjums darbojas ar dm frekvencm:
175 kHz; 10 metru attlum magntisk lauka stiprums ir mazks par 30 dBA/m;
2,4-2,4835 GHz josla;
radiofrekvences izvades jauda ir mazka par 10 mW
(ekvivalent izotropiski izstarot jauda). Dutch Hierbij verklaart Medtronic dat deze radioapparatuur modelnummer TM90 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 de volgende frequenties:
175 kHz met een H-
veldsterkte van minder dan 30 dBA/m bij 10 m 2,4-2,4835 GHz-band met een RF-uitgangsvermogen van minder dan 10 mW e.i.r.p. Polish Firma Medtronic deklaruje niniejszym, e to urzdzenie radiowe, model numer TM90, 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 nastpujcych czstotliwociach:
175 kHz z nateniem pola H mniejszym ni 30 dBA/m w odlegoci 10 m;
w pamie 2,4-2,4835 GHz z rwnowan moc wyjciow RF wypromieniowan izotropowo (EIRP) mniejsz ni 10 mW. Portuguese Por este meio, a Medtronic declara que este modelo de equipamento de rdio, nmero TM90, 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 nas frequncias seguintes:
175 kHz com uma fora de campo H inferior a 30 dBA/m a 10 m 2,4-2,4835 GHz com uma potncia de sada de RF inferior a 10 mW e.i.r.p. Romanian Prin prezenta, Medtronic declar c acest echipament radio numr model TM90 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 urmtoarele frecvene:
175 kHz cu o putere a cmpului H de mai puin de 30 dBA/m la 10 m n banda 2,4-2,4835 GHz cu o putere de ieire RF de mai puin de 10 mW E.I.R.P. Slovak Spolonos Medtronic tmto vyhlasuje, e toto rdiov zariadenie, model TM90, 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 nasledujcich frekvencich:
175 kHz s intenzitou poa H niou ako 30 dBA/m na vzdialenos 10 m 2,4-2,4835 GHz psmo s RF vstupnm vkonom nim ako 10 mW EIRP Slovenian Druba Medtronic izjavlja, da je ta radijska oprema, tevilka modela TM90, 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 naslednjih frekvencah:
175 kHz z jakostjo magnetnega polja H manj kot 30 dBA/m pri 10 m 2,4-2,4835 GHz z izhodno mojo RF manj kot 10 mW e.i.m.o. (EIRP) Swedish Hrmed intygar Medtronic att denna radioutrustning med modellnummer TM90 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 fljande frekvenser:
175 kHz med en H-fltstyrka p mindre n 30 dBA/m p 10 m 2,4-2,4835 GHz-band med en RF-uteffekt p mindre n 10 mW e.i.r.p. Maltese Hawnhekk, Medtronic tiddikjara li dan it-Tagmir tar-Radju bin-
numru tal-mudell TM90 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 fil-
frekwenzi li ejjin:
175 kHz bsaa H-field ta anqas minn 30 dBA/m fdistanza ta' 10 m 2.4-2.4835 GHz band b'RF output power ta' inqas minn 10 mW e.i.r.p. Fold Fold Fold Fold Fold Fold Fold Fold Fold
1 2 | Users manual | Users Manual | 3.82 MiB |
Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Communicator Instructions for use TM90 Rx only M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Medtronic, Medtronic logo, and Further, Together are trademarks of Medtronic. The BLUETOOTH word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Medtronic is under license. M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Label Symbols Explanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply. Consult instructions for use Conformit Europenne (European Conformity). This symbol means that the device fully complies with AIMD Directive 90/385/EEC (NB 0123). Class II equipment ON-OFF (Stand-by) Reorder number Authorized Representative in the European Community Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://
recycling.medtronic.com for instructions on proper disposal of this product. REF EC REP l s o b m y S l e b a L TM902018-04-30English 3 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Rx only MR For USA audiences only Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Manufacturer Date of manufacture Use by IEC60601-1/EN60601-1, Type BF equipment Direct Current Magnetic Resonance (MR) Unsafe Serial number PIN number Keep dry
+XX C
+XXX F
-XX C
-XX F Temperature limitation The Technical Conformity mark signifies that this device complies with Japan Radio Law. l s o b m y S l e b a L 4 EnglishTM902018-04-30 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 The RCM Certification mark signifies that this device complies with Australia/NewZealand EMC requirements for electrical and electronic equipment. Chinese Standard (SJ/T11364-2006) Logo: Electronic Information Products Pollution Control Symbol. (The "e" in this logo signifies none of the restricted substances are present above permitted levels.) The KCC Certification mark signifies that this device complies with South Korea's radio requirements for telecommunication equipment. l s o b m y S l e b a L TM902018-04-30English 5 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 l s o b m y S l e b a L 6 EnglishTM902018-04-30 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Table of contents Label Symbols 3 1Introduction 10 How to use this manual 10 Patient information 11 Purpose and description 11 Warnings 12 Precautions 12 How to contact Medtronic 13 2Using the communicator 16 Package contents 16 How the communicator works 16 Instructions for use 17 Declaration of conformity 18 Communicator overview 19 Turning on the device 20 Connecting to the handset 21 Turning off the device 22 Charging the device 23 TM902018-04-30English M966423A001Rev D2018-04-30 s t n e t n o c f l o e b a T 7 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 3Troubleshooting and device care 28 Troubleshooting 28 Electromagnetic interference 28 Safety and technical checks 29 Device care 30 Specifications 31 Index 34 s t n e t n o c f l o e b a T 8 EnglishTM902018-04-30 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 1Introduction M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 How to use this manual This manual contains information for patients and clinicians about the communicator device. Please read the entire manual before using the device. Chapter 1 Introduction explains how to use this manual, and provides patient information. This chapter describes the device and its purpose, and provides warnings, precautions, and Medtronic contact information. Chapter 2 Using the communicator lists items in the product package, and gives instructions for using the device. Chapter 3 Troubleshooting and device care provides information on electromagnetic interference (EMI), troubleshooting, and tips on caring for the device. This chapter also provides specifications, and information on who to call for assistance. EnglishTM902018-04-30 1 n o i t c u d o r t n I 10 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Patient information You should have received additional manuals specific to your therapy. Review these materials, and keep them in a convenient location. Purpose and description The Medtronic Model TM90 Communicator is intended for patient or clinician use, to connect the app installed on the Model HH90 handset to the implanted medical device. The app on the handset interacts with the implanted medical device through the communicator. The communicator contains a lithium-ion battery that will need to be regularly charged. The communicator can be used in a home or health care setting. For complete information, refer to the therapy manuals associated with your medical device. TM902018-04-30English M966423A001Rev D2018-04-30 1 n o i t c u d o r t n I 11 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Warnings Sterile fieldAvoid using the device in a sterile field. If it is necessary, place the device into a sterile bag or use a sterile barrier. The device is not sterile and cannot be sterilized. Failure to use a sterile bag or barrier may cause an infection. Wound contactDo not use the device on an unhealed wound. Place a sterile bandage or barrier between the wound and device. The device is not sterile. Contact with the wound without a sterile bandage or barrier may cause an infection. Precautions DisposalDispose of the communicator according to local regulations, or consult http://recycling.medtronic.com. Failure to dispose of the device correctly may lead to environmental damage. EnglishTM902018-04-30 1 n o i t c u d o r t n I 12 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 How to contact Medtronic For assistance in the US, call
+1 800 510 6735. Outside the US, call the phone numbers found at the back of the manual. 1 n o i t c u d o r t n I 13 TM902018-04-30English M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 1 n o i t c u d o r t n I 14 EnglishTM902018-04-30 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 2Using the communicator M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Package contents The Medtronic Model TM90 Communicator package contains the following parts:
Model TM90 Communicator Product literature The USB charging cable and AC adaptor are included in the handset package. Use this cable or another USB 2.0 compliant cable to charge the device. How the communicator works The communicator acts as a wireless "bridge"
between the app installed on the handset, and the implanted medical device. The implanted device only accepts communications from the app through the communicator. Sending information between the app and implanted device, through the communicator, will only occur after the app and communicator have been "paired". Pairing will take place before first use of the app. EnglishTM902018-04-30 i t 2 r o a c n u m m o c e h t g n s U i 16 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 For a new communicator that has not been paired with the app, or for any other reason the communicator is not paired with the app, refer to the app user guide for pairing instructions or troubleshooting. Instructions for use This section provides instructions for turning the communicator on and off, connecting it to the handset, and charging the communicator. For instructions on connecting the communicator and app with the implanted device, refer to the appropriate app user guide that is included in the communicator package. Notes:
Allow 15 minutes for the communicator to warm up before use, after being stored at the minimum storage temperature. Allow 15 minutes for the communicator to cool down before use, after being stored at the maximum storage temperature. TM902018-04-30English M966423A001Rev D2018-04-30 i t 2 r o a c n u m m o c e h t g n s U i 17 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 During a therapy session, hold the communicator over the implanted device, no more than 4 cm away from the body. If the communicator warms during a therapy session, and this is uncomfortable against your skin, place a thin layer of clothing between the communicator and skin. For additional guidance on how and where to place the communicator, refer to the app user guide that is included in the communicator package. Declaration of conformity Medtronic declares that the Medtronic Model TM90 Communicator is in conformity with the essential requirements of Directive 90/385/EEC on Active Implantable Medical Devices. For additional information, call the appropriate phone number found at the back of this manual. EnglishTM902018-04-30 i t 2 r o a c n u m m o c e h t g n s U i 18 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Communicator overview USB charging cable Battery indicator BLUETOOTH technology indicator Power (Stand-by) button Figure 2.1Communicator The communicator includes a power button and USB charging port. A battery indicator light shows when the battery is low (yellow), charging (orange), or fully charged (green). The BLUETOOTH technology indicator light
(blue) shows if the communicator is connected to the handset. TM902018-04-30English M966423A001Rev D2018-04-30 i t 2 r o a c n u m m o c e h t g n s U i 19 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Turning on the device Power button Press the power button until the blue light blinks. Figure 2.2Turn the power on The ON-OFF (Stand-by) symbol (
power button lights up when the device is on.
) on the i t 2 r o a c n u m m o c e h t g n s U i 20 EnglishTM902018-04-30 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Connecting to the handset BLUETOOTH technology indicator
(blue) The blue light blinks until the communicator connects to the handset and the app. The light turns solid blue when the communicator is connected. Figure 2.3BLUETOOTH technology indicator The blue light provides information on connection status between the communicator and the app on the handset. i t 2 r o a c n u m m o c e h t g n s U i 21 TM902018-04-30English M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Turning off the device Power button Press the power button for at least 3 seconds or until the lights turn off. Note that the communicator will turn off after 3 minutes if not connected to the handset. Figure 2.4Turn the power off The power button and indicator lights turn off. i t 2 r o a c n u m m o c e h t g n s U i 22 EnglishTM902018-04-30 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Charging the device Battery indicator (yellow) The battery indicator turns yellow when the battery has a low charge. The communicator will not connect to the implanted device while it is charging. Figure 2.5Low battery A yellow battery indicator light means that it is time to charge the communicator. Use the USB charging cable and AC adaptor included in the handset package, or another USB 2.0 compliant cable. i t 2 r o a c n u m m o c e h t g n s U i 23 TM902018-04-30English M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 For best results, charge the communicator overnight, so it is fully charged and ready for use at the beginning of the day. USB charging cable Battery indicator (orange) Insert the USB charging cable into the communicator charging port. Connect the AC adaptor on the other end to a power source or wall outlet. The battery indicator turns orange when the battery is charging. Figure 2.6Charging the battery While charging, the device will turn off after 3 minutes, if it is not communicating with the handset. The communicator will continue to charge. Press the power button to turn off the communicator immediately. It will continue to charge while off. EnglishTM902018-04-30 i t 2 r o a c n u m m o c e h t g n s U i 24 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 A green battery indicator light means that the communicator is fully charged, and ready for use. USB charging cable Battery indicator (green) The battery indicator turns green when fully charged. It remains green until the communicator is removed from the power source. Figure 2.7Fully charged battery When the device is disconnected from the power source, the battery indicator light and power light will turn off. i t 2 r o a c n u m m o c e h t g n s U i 25 TM902018-04-30English M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 i t 2 r o a c n u m m o c e h t g n s U i 26 EnglishTM902018-04-30 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 3 Troubleshooting and device care M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 This chapter provides information on troubleshooting, electromagnetic interference
(EMI), and care for the communicator device. This chapter also provides specifications, and information on who to call for assistance. Troubleshooting While charging, the communicator will not connect to the implanted medical device. Use of the communicator is specific to the medical device. Refer to the app user guide to troubleshoot possible issues while using the communicator with the app. Software updates are sent to the communicator if needed. For assistance or questions, refer to "How to contact Medtronic" on page 13. Electromagnetic interference Electromagnetic interference (EMI) is a field of energy made by equipment found in the home, work, medical, or public environments. EMI may be strong enough to interfere with 3 e r a c e c v e d d n a i g n i t o o h s e b u o r T l 28 EnglishTM902018-04-30 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 the connection between the handset and implanted device. Refer to the app user guide included in the communicator package, for more information on EMI. The therapy manuals associated with your medical device will also provide information about sources of EMI and advice on how to avoid this type of interference. Safety and technical checks Safety checks are not required for the Model TM90 Communicator. Maintenance is not necessary, because the communicator does not contain serviceable components. If the communicator or handset was lost or damaged, call Medtronic for further assistance. Refer to "How to contact Medtronic" on page 13 or refer to the back cover of the manual. TM902018-04-30English M966423A001Rev D2018-04-30 3 e r a c e c v e d d n a i g n i t o o h s e b u o r T l 29 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Device care Follow these guidelines to ensure that the communicator operates properly. Charge the communicator at least every 6 months, even if it is not in use, to ensure the battery maintains power. Clean the communicator with a damp cloth or sponge. Mild household or medical cleaners will not damage the device. Clinicians should clean the device between uses on different patients. Keep the device and USB charging cable out of the reach of children and pets. Follow all warnings and the precaution in this manual. Handle the device with care. Do not drop, strike, or step on it. Do not dismantle or tamper with the device. 3 e r a c e c v e d d n a i g n i t o o h s e b u o r T l 30 EnglishTM902018-04-30 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 The communicator is not waterproof. Do not allow moisture to get inside of the device. Specifications Table 3.1Communicator Item Power source Battery life -
Clinician use Battery life -
Patient use Service life Operating temperature Storage temperature Size
(approximate) Weight, including batteries
(approximate) Specification Rechargeable battery, USB 2.0 compliant cable with external power supply 2 hours per day with power on 30 minutes per day with power on 2 years minimuma 5C to 40Cbc
(41F to 104F)
-25C to 70Cd
(-13F to 158F) 60.25 mm x 121.25 mm x 9.35 mm
(2.4 in x 4.8 in x .37 in) 57 g (2 oz) TM902018-04-30English M966423A001Rev D2018-04-30 3 e r a c e c v e d d n a i g n i t o o h s e b u o r T l 31 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Table 3.1Communicator (continued) Item Mode of operation Classification Case material Specification Continuous Internally powered Polycarbonate/ABS blend plastic resin a Communicator can continue to be used after the minimum service life has elapsed. b A relative humidity range of 15% to 90%, non-
condensing, but not requiring a water vapour partial pressure greater than 50 hPa; and an atmospheric pressure range of 700 hPa to 1060 hPa. c At the upper range of operating temperature, the communicator may reach 43C (109F). d 5C to 35C at a relative humidity up to 90%, non-
condensing; and >35C to 70C at a water vapour pressure up to 50 hPa. Table 3.2Charger Item Rated Input Rated Output Isolation Mark Specification 100-240V ~ 50-60Hz, 0.15A 5.0V Class II equipment 1.0Aa 3 e r a c e c v e d d n a i g n i t o o h s e b u o r T l 32 EnglishTM902018-04-30 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Table 3.2Charger (continued) Item Certification Charging Cord a Minimum Specification Agency certified Micro USB 2.0 standard compliant 3 e r a c e c v e d d n a i g n i t o o h s e b u o r T l 33 TM902018-04-30English M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Index BLUETOOTH technology indicator 21 Charging the battery 24 Cleaning the device 30 Components 16 Contacting Medtronic 13 Device care guidelines 30 Disposal Recycling 12 Electromagnetic interference 28 Fully charged battery 25 Indicator lights 19 Low battery charge 23 Pairing 16 Placement of the communicator 18 Power button 20,22 Replacement 29 Software updates 28 Specifications 31,32 Sterile field 12 System components 16 EnglishTM902018-04-30 x e d n I 34 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Temperature Operating 31 Storage 17,31 Troubleshooting 28 USB charging cable 16,23,30 AC adaptor 16 Wound contact 12 TM902018-04-30English x e d n I 35 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 Contacts:
Asia: Medtronic International Ltd. Tel. 02919-1300 Australia: Medtronic Australasia P/L Tel. +61-2-9857-9000 Toll-free 1-800-668-670 Austria: Medtronic sterreich GmbH Tel. 01-240440 Belgium: Medtronic Belgium S.A. Tel. 02-456-0900 Canada: Medtronic of Canada Ltd. Tel. (1-905)-460-3800 Czech Republic: Medtronic Czechia s.r.o. Tel. 2-330-591-11 Denmark: Medtronic Danmark A/S Tel. 45-32-48-18-00 Finland: Medtronic Finland Oy/LTD Tel. (09) 207-281-210 France: Medtronic France S.A.S. Tel. 01-5538-1700 Germany: Medtronic GmbH Tel. (02159)-81490 Greece: Medtronic Hellas S.A. Tel. 210-67-79-099 Hungary: Medtronic Hungria Kft. Tel. 1-889-06-00 Ireland: Medtronic Ireland Ltd. Tel. (01) 511-1400 Italy: Medtronic Italia SpA Tel. 02-241371 Japan: Medtronic Japan Tel. 03-6776-0017 Latin America: Medtronic, Inc. Tel. (1305)-500-9328 Norway: Medtronic Norge AS Tel. 67-10-32-00 Poland: Medtronic Poland Sp. z.o.o. Tel. (022)-465-69-00 Portugal: Medtronic Portugal, Lda. Tel. 21-724-5100 Russia: Medtronic Russia Tel. (7495) 580-7377 Slovakia: Medtronic Slovakia, o.z. Tel. 0268 206 911 Spain: Medtronic Ibrica, S.A. Tel. 91-625-0400 Sweden: Medtronic AB Tel. 08-568-585-00 Switzerland: Medtronic (Schweiz) AG Tel. 031-868-0100 The Netherlands: Medtronic B.V. Tel. (045)-566-8000 Turkey: Medtronic Turkey Tel. +90 216 636 1000 U.K.: Medtronic U.K. Ltd. Tel. 01923-212213 USA: Medtronic, Inc. Tel. (1-763)-505-5000 Toll-free: (1-800)-328-0810 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 M966423A001Rev D2018-04-30 Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (118 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Template version 6.2: 06-14-2017 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 Contacts for specific countries are listed inside this cover.
*M966423A001*
Medtronic, Inc. 2018 All Rights Reserved M966423A001 Rev D M966423A001Rev D2018-04-30
1 2 | Internal photographs | Internal Photos | 1.37 MiB |
Testing and certification of electronic and electric appliances, systems, installations and telecommunication systems PHOTOGRAPHS OF THE INTERIOR OF A BRAND MEDTRONIC, MODEL TM90 MODELNAME: Communicator Page 1 of 10 TV Rheinland Nederland B.V. Eiberkamp 10 9351VT Leek The Netherlands Telephone: +31 594 505005 Telefax: +31 594 504804 Internet: www.tuv.com/nl E-mail: products@nl.tuv.com Report number: 16110401.p01 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90
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Low Power Communication Device Transmitter (DXX) Medtronic, Inc. Medtronic TM90 Communicator Guillaume Girard Medtronic, Inc. 710 Medtronic Parkway NE 55432 Minneapolis MN USA Office 763.526.0652 | Mobile 612.991.3108
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g.guillaume@medtronic.com
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R. van der Meer July 10, 2017 Description of test item EUT Manufacturer Brand Model Modelname Applicant information Applicant's representative Company Address Postal code City Country Telephone number Telefax number Email Report written by Report date Report number: 16110401.p01 Page 2 of 10 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90 Table of contents 1.1 1.2 1.3 1.4 1.5 1.6 INTERNAL VIEW, COVER REMOVED................................................................................................................................. 4 INTERNAL VIEW, 175 KHZ ANTENNA REMOVED. ........................................................................................................... 5 INTERNAL VIEW, BATTERY REMOVED ............................................................................................................................. 6 INTERNAL VIEW, BATTERY REMOVED BATTERYS BACK SIDE SHOWN ........................................................................ 7 INTERNAL VIEW, VIEW OF THE FRAME WITHOUT PCB ..................................................................................................... 8 INNER ASSEMBLY, PCB VIEW......................................................................................................................................... 9 PCB view, Front side .......................................................................................................................................... 9 PCB view, Back side .......................................................................................................................................... 9 1.6.1 1.6.2 Report number: 16110401.p01 Page 3 of 10 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90 1.1 Internal view, cover removed. Report number: 16110401.p01 Page 4 of 10 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90 1.2 Internal view, 175 kHz antenna removed. Report number: 16110401.p01 Page 5 of 10 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90 Internal view, battery removed 1.3 Report number: 16110401.p01 Page 6 of 10 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90 Internal view, Battery removed batterys back side shown 1.4 Report number: 16110401.p01 Page 7 of 10 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90 1.5 Internal view, view of the frame without pcb Report number: 16110401.p01 Page 8 of 10 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90 1.6 Inner assembly, PCB view 1.6.1 PCB view, Front side 1.6.2 PCB view, Back side Report number: 16110401.p01 Page 9 of 10 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90
< END of REPORT >
Report number: 16110401.p01 Page 10 of 10
1 2 | External photographs | External Photos | 328.57 KiB |
Testing and certification of electronic and electric appliances, systems, installations and telecommunication systems PHOTOGRAPHS OF THE EXTERIOR OF A BRAND MEDTRONIC, MODEL TM90 MODELNAME: Communicator Page 1 of 8 TV Rheinland Nederland B.V. Eiberkamp 10 9351VT Leek The Netherlands Telephone: +31 594 505005 Telefax: +31 594 504804 Internet: www.tuv.com/nl E-mail: products@nl.tuv.com Report number: 16110401.p02 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90
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Low Power Communication Device Transmitter (DXX) Medtronic, Inc. Medtronic TM90 Communicator EUT1 N (Normal Operation- 20:5B:2A:47:09:8B) and EUT2(-) Guillaume Girard Medtronic, Inc. 710 Medtronic Parkway NE 55432 Minneapolis MN USA Office 763.526.0652 | Mobile 612.991.3108
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g.guillaume@medtronic.com
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R. van der Meer July 06, 2017 Description of test item EUT Manufacturer Brand Model Modelname Serial Number Applicant information Applicant's representative Company Address Postal code City Country Telephone number Telefax number Email Report written by Report date Report number: 16110401.p02 Page 2 of 8 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90 Table of contents 1 PHOTOGRAPHS OF THE EQUIPMENT. ...................................................................................................................... 4 1.1 1.1.1 1.1.2 EXTERNAL VIEW. ........................................................................................................................................................... 4 Front view. ........................................................................................................................................................... 4 Rear view .............................................................................................................................................................. 5 SIDE VIEWS ..................................................................................................................................................................... 6 1.2 Report number: 16110401.p02 Page 3 of 8 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90 1 Photographs of the equipment. 1.1 External view. 1.1.1 Front view. Page 4 of 8 Report number: 16110401.p02 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90 1.1.2 Rear view Report number: 16110401.p02 Page 5 of 8 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90 1.2 Side views Left side view Right side view Report number: 16110401.p02 Page 6 of 8 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90 Top view Report number: 16110401.p02 Page 7 of 8 Manufacturer:
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Medtronic, Inc. Medtronic TM90 Communicator LF5TM90 3408D-TM90 Bottom view Report number: 16110401.p02 Page 8 of 8
1 2 | Label / label location | ID Label/Location Info | 200.11 KiB |
Label info Location of productlabel on device
1 2 | Authorisation letter | Cover Letter(s) | 1.72 MiB |
Medtronic Medtronic, Inc. Cardiac Rhythm and Heart Failure 8200 Coral Sea Street NE, MVS11 Mounds View, MN 55112 USA www.medtronic.com tel 763.526.0664 fax 651.367.0603 Charles S. Farlow Program Director, Regulatory Affairs November 27, 2016 Federal Communications Commission Laboratory Division 7435 Oakland Mills Rd Columbia, MD 21045 Attn: Axel Rodriguez Equipment Authorization and Compliance Branch Chief Dear Mr. Rodriguez,
|, the undersigned, as the authorized signatory for Medtronic, Inc., grantee code LF5, hereby authorize Guillaume Girard, EMC & RF Regulatory Compliance Manager of Medtronic, Inc., to act on my behalf in all manners relating to the following applications for equipment authorization, including signing of all documents relating to these applications:
FCCID:
PCA, A. FCC ID:
PO i. FCC ID:
PCC ID:
LF54NRO003 LF597715 LF597716 LF5TM90 LF58880T2 LF597745 FCC ID: LF537858 FCCID: LF57AY1R2 FCC ID: LF597800 FCC ID: LF5B35300R Any and all acts carried out by Guillaume Girard of Medtronic, Inc. on our behalf shall have the same effects as acts of my own. This authorization shall be sent along with each application when filing with the FCC or TCB for certification of products covered by the above specified FCC ID's. If there are any questions related to this letter, please contact me at charles.s.farlow@medtronic.com
(mobile 763.742.5158). Respectfully, BL 41. Charles S. Farlow
1 2 | Confidentiality request | Cover Letter(s) | 16.49 KiB |
A
s E By 5 8
H E E A a4 ig EB a 4
J ant to section 0.457(d)(2)(i) and Section 0.459 of the FCC rules we herewith Ea cell ColeUavem Pale) Medel Cre MoM LCE-1s))[[er-1 (eo) ere ED) ithheld from public inspection and to be kept confidential ontents of these exhibits may not be disclosed to other parties than ronic and TUV Rheinland Nederland B V.:
ircuit diagram Yao ael elec) 3 Operational description The reason for this request for confidentiality is that the information contained in the exhibits as listed above has been classified as company confidential Disclosure of an portion of this information to other parties would cause substantial competitive harm. Best regards Medtronic Inc Guillaume Girard RTG Implants EMC and RF Regulatory Manager Medtronic Inc. 710 Medtronic Parkway NE Minneapolis, 55432, USA Attn.: Mrs. S Holman Certification Department 6731 Whittier Avenue, Suite C110 inia 22104 wed a SO edn Version: 2010110'
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2017-11-22 | 0.175 ~ 0.175 | DCD - Part 15 Low Power Transmitter Below 1705 kHz | Original Equipment |
2 | 2402 ~ 2480 | DXX - Part 15 Low Power Communication Device Transmitter |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2017-11-22
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||||
1 2 | Applicant's complete, legal business name |
Medtronic, Inc.
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1 2 | FCC Registration Number (FRN) |
0008250839
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1 2 | Physical Address |
8200 Coral Sea Street NE
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1 2 |
Mounds View
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1 2 |
United States
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app s | TCB Information | |||||
1 2 | TCB Application Email Address |
h******@acbcert.com
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1 2 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
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||||
1 2 |
A2: Low Power Transmitters (except Spread Spectrum) and radar detectors operating above 1 GHz
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app s | FCC ID | |||||
1 2 | Grantee Code |
LF5
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1 2 | Equipment Product Code |
TM90
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
G**** G********
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1 2 | Title |
Sr. RF Regulatory Program Manager
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1 2 | Telephone Number |
763-5********
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||||
1 2 | Fax Number |
651-3********
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||||
1 2 |
G******@medtronic.com
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|||||
app s | Technical Contact | |||||
1 2 | Firm Name |
Medtronic, Inc.
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||||
1 2 | Name |
G******** G********
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||||
1 2 | Physical Address |
710 Medtronic Parkway NE
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||||
1 2 |
Minneapolis, Minnesota 55432
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|||||
1 2 |
United States
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|||||
1 2 | Telephone Number |
763.5********
|
||||
1 2 |
g******@medtronic.com
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|||||
app s | Non Technical Contact | |||||
1 2 | Firm Name |
Medtronic, Inc.
|
||||
1 2 | Name |
G****** G********
|
||||
1 2 | Physical Address |
710 Medtronic Parkway NE
|
||||
1 2 |
Minneapolis, Minnesota 55432
|
|||||
1 2 |
United States
|
|||||
1 2 | Telephone Number |
763.5********
|
||||
1 2 |
g******@medtronic.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 2 | 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 2 | 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?: | No | ||||
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 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DCD - Part 15 Low Power Transmitter Below 1705 kHz | ||||
1 2 | DXX - Part 15 Low Power Communication Device Transmitter | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Communicator | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | 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 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | 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 2 | Firm Name |
TUV Rheinland Nederland B.V.
|
||||
1 2 | Name |
R******** v******
|
||||
1 2 | Telephone Number |
31-08********
|
||||
1 2 | Fax Number |
31-59********
|
||||
1 2 |
r******@nl.tuv.com
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC | 0.17500000 | 0.17500000 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 2402.00000000 | 2480.00000000 |
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