TM91 Communications Regulation Reference Sheet Communications Regulations The following is a list of communications regulations that apply to the Model TM91 US Federal Communications Commission (FCC) This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150406.000 MHz band in the Meteorological Aids
(i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. Canada Compliance (ISED) This device may not interfere with stations operating in the 400.150-406.000 MHz band in the meteorological aids, meteorological-
satellite, and earth exploration-
satellite services, and must accept any interference received, including interference that may cause undesired operation. Manufacturer Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA www.medtronic.com Tel. +1-763-505-5000 Authorized Representative in the European Community Medtronic B.V. Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands Tel. +31-45-566-8000 EC REP 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 B
*M971971A001*
United States Compliance FCC ID: LF5TM91 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-TM91 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-21775 This product conforms to Argentina Radio Requirements. Este producto cumple los requisitos de Argentina relativos a la radioelectricidad. Korea Compliance MSIP RMI-MKL-TM91 This radio device has possibility of radio interference during operation. Singapore Compliance Dealer License # DA103452 This product complies with IMDA Standards.
IDA
Malaysia Compliance HIDF15000146 Japan Compliance R: 208-180097 This product conforms to Japan Radio Law Requirements. 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. European Union Compliance Conformit Europenne
(European Conformity) Hereby, Medtronic declares that this Radio Equipment Model number TM91 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 band with an RF output power of less than 10 mW e.i.r.p 402-405 MHz band with an effective radiated power of less than 0.5 W (e.r.p.). Bulgarian Medtronic
, TM91 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 TM91, 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 2,4-2,4835 GHz, piem vstupn RF vkon je ni ne 10 mW EIRP 402-405 MHz, piem efektivn vyza ovan vkon je ni ne 0.5 W ERP. N ot for M edical U se Draft Danish Medtronic erklrer hermed, at dette radioudstyr modelnummer TM91 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. 402-405 MHz-bndet med en effektiv udstrlet effekt p mindre end 0.5 W e.r.p. German Hiermit erklrt Medtronic, dass dieses Funkgertmodell Nr. TM91 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 402-405 MHz und einer effektiven Strahlungsleistung von weniger als 0.5 W ERP. Greek
, Medtronic M TM91 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. (
) Estonian Kesolevaga kinnitab Medtronic, et see raadioseadmestik mudelinumbriga TM91 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. 402405 MHz efektiivse kiirgusvimsusega vhem kui 0.5 W e.r.p. Finnish Medtronic vakuuttaa tten, ett tm radiolaite, mallinumero TM91, 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 402405 MHz:n kaistalla, ja sen efektiivinen steilyteho on alle 0.5 W ERP French Par la prsente, Medtronic dclare que cet quipement radio Modle TM91 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 dans la bande de 402 405 MHz avec une puissance rayonne effective infrieure 0.5 W PRE Croatian Ovime tvrtka Medtronic izjavljuje da je ova radijska oprema model TM91 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 pri frekvenciji 402-405 MHz s djelotvornom zra enom snagom manjom od 0.5 W e.r.p Hungarian A Medtronic ezton nyilatkozza, hogy ez az TM91 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 402405 MHzes svban m kdik gy, hogy tnyleges sugrzott teljestmnye kevesebb, mint 0.5 W ERP Italian Con il presente documento, Medtronic dichiara che la presente apparecchiatura radio modello TM91 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 banda a 402405 MHz con una potenza irradiata equivalente inferiore a 0.5 W ERP Lithuanian iuo Medtronic deklaruoja, kad is radijo rangos modelis, kurio numeris TM91, 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. 402-405 MHz danio diapazone, efektyvi skleidiama galia yra maesn nei 0.5 W ERP Latvian Ar o uzmums Medtronic apliecina, ka radioiekrta, modea numurs TM91, 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 TM91 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. 402-405 MHz-band met een effectief uitgestraald vermogen van minder dan 0.5 W e.r.p. N ot for M edical U se Draft Polish Firma Medtronic deklaruje niniejszym, e to urzdzenie radiowe, model numer TM91, 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 TM91, 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. 402 405 MHz com uma potncia irradiada efetiva inferior a 0.5W e.r.p Romanian Prin prezenta, Medtronic declar c acest echipament radio numr model TM91 ste 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 TM91, 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 402 405MHz s efektvnym vyarovanm vkonom nim ako 0.5 W ERP Slovenian Druba Medtronic izjavlja, da je ta radijska oprema, tevilka modela TM91, 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) 402-405MHz z u inkovito mojo oddajanja manj kot 0.5 W e.m.o. (ERP) Swedish Hrmed intygar Medtronic att denna radioutrustning med modellnummer TM91 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. 402405 MHz-bandet med en effektivt sndningseffekt p mindre n 0.5 W e.r.p. Maltese Hawnhekk, Medtronic tiddikjara li dan it-Tagmir tar-Radju bin-
numru tal-mudell TM91 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. 402-405 MHz band b'radiated power effettiv ta'
inqas minn 0.5 W e.r.p Spanish Por la presente, Medtronic declara que este equipo de radio, modelo nmero TM91 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 Banda de frecuencia de 402-405 MHz con una potencia radiada efectiva
(PRE) de menos de 0.5 W N ot for M edical U se Draft