97715 Implantable Neurostimulator ID Label/Location Info M960498A_a_001_view_01 Medtronic, Inc.

Medtronic, Inc. Implantable Neurostimulator

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Communications Regulations
The following is a list of communications regulations
that apply to the Model 97715.
97715 Communications Regulation
Reference Sheet
United States Compliance
FCC ID: LF597715
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.
This transmitter is authorized
by rule under the Medical
Device Radio communication
Service (in part 95 of the FCC
Rules) and must not cause
harmful interference to stations
operating in the
400.150-406.000 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 Radio
communication 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.
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.
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
Canada Compliance
MODEL: 97715 & B35300R
EC REP
IC: 3408D-97715
Europe/Africa/Middle East Headquarters
Medtronic International Trading Sàrl
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,
© Medtronic, Inc. 2017
Hong Kong
All Rights Reserved
Tel. +852-2919-1300
M960498A001 Rev A
Fax +852-2891-6830
*M960498A001*
௑2017-03-01
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.
Le présent dispositif ne doit
pas causer de brouillage aux
stations du service des
auxiliaires de la météorologie,
des satellites météorologiques,
du service d'exploration de la
terre par satellite, exploitées
dans la bande
400,150-406,000 MHz, et il doit
accepter tout brouillage reçu, y
compris le brouillage pouvant
entraîner un mauvais
fonctionnement du dispositif.
This device complies with
Industry Canada licenseexempt 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 présent appareil est
conforme aux CNR d'Industrie
Canada applicables aux
appareils radio exempts de
licence. L'exploitation est
autorisée aux deux conditions
suivantes : (1) l'appareil ne doit
pas produire de brouillage, et
(2) l'appareil doit accepter tout
brouillage radioélectrique subi,
même si le brouillage est
susceptible d'en compromettre
le fonctionnement.
Brazil Compliance
1084-16-5567
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
caráter secundário isto é, não
tem direito à proteção contra
interferência prejudicial,
mesmo de estações do mesmo
tipo, e não pode causar
interferência a sistemas
operando em caráter primário.
Australia and New Zealand
Compliance
This product conforms to
Australia and New Zealand
Radio Requirements.
European Union Compliance
Conformité Européenne
(European Conformity)
Hereby, Medtronic declares
that this Radio Equipment
Model number 97715 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 in the
402-405 MHz band with an
effective radiated power of less
than 0.5 μW (e.r.p.).
Bulgarian
ɋ ɧɚɫɬɨɹɳɨɬɨ Medtronic
ɞɟɤɥɚɪɢɪɚ, ɱɟ ɬɨɜɚ
ɪɚɞɢɨɨɛɨɪɭɞɜɚɧɟ ɦɨɞɟɥ
ɧɨɦɟɪ 97715 ɟ ɜ
ɫɴɨɬɜɟɬɫɬɜɢɟ ɫ Ⱦɢɪɟɤɬɢɜɚ
2014/53/ȿɋ. ɉɴɥɧɢɹɬ ɬɟɤɫɬ ɧɚ
ȿɋ ɞɟɤɥɚɪɚɰɢɹɬɚ ɡɚ
ɫɴɨɬɜɟɬɫɬɜɢɟ ɟ ɧɚ
ɪɚɡɩɨɥɨɠɟɧɢɟ ɧɚ ɫɥɟɞɧɢɹ
ɢɧɬɟɪɧɟɬ ɚɞɪɟɫ:
www.MedtronicCompliance.eu
Ɍɨɡɢ ɩɪɨɞɭɤɬ ɪɚɛɨɬɢ ɜ ɥɟɧɬɚ
ɨɬ 402–405 MHz ɫ ɟɮɟɤɬɢɜɧɚ
ɢɡɥɴɱɜɚɧɚ ɦɨɳɧɨɫɬ ɩɨɞ 0.5
μW e.r.p.
Czech
Spoleþnost Medtronic tímto
prohlašuje, že toto radiové
zaĜízení, þíslo modelu 97715,
odpovídá požadavkĤm
smČrnice 2014/53/EU. Úplný
text EU Prohlášení o shodČ je
k dispozici na následující
internetové adrese:
www.MedtronicCompliance.eu
Tento výrobek používá
frekvenþní pásmo
402-405 MHz, pĜiþemž
efektivní vyzaĜovaný výkon je
nižší než 0.5 μW ERP.
Käesolevaga kinnitab
Medtronic, et see
raadioseadmestik
mudelinumbriga 97715 on
vastavuses direktiiviga
2014/53/EL. Kogu EL-i
vastavusdeklaratsiooni tekst on
saadaval järgmisel
internetiaadressil:
www.MedtronicCompliance.eu
See toode töötab ribalaiusel
402–405 MHz efektiivse
kiirgusvõimsusega vähem kui
0.5 μW e.r.p.
Danish
Finnish
Medtronic erklærer hermed, at
dette radioudstyr
modelnummer 97715 er i
overensstemmelse med
direktiv 2014/53/EU. Den fulde
tekst i EUoverensstemmelseserklæringen kan læses her:
www.MedtronicCompliance.eu
Medtronic vakuuttaa täten, että
tämä radiolaite, mallinumero
97715, vastaa direktiiviä
2014/53/EU. EUvaatimustenmukaisuusvakuutuksen koko teksti on
saatavissa seuraavasta
Internet-osoitteesta:
www.MedtronicCompliance.eu
Dette produkt fungerer i
402-405 MHz-båndet med en
effektiv udstrålet effekt på
mindre end 0.5 μW e.r.p.
Tämä tuote toimii 402–405
MHz:n kaistalla, ja sen
efektiivinen säteilyteho on alle
0.5 μW ERP.
German
French
Hiermit erklärt Medtronic, dass
dieses Funkgerätmodell Nr.
97715 der Richtlinie
2014/53/EU entspricht. Der
vollständige Text der EUKonformitätserklärung steht
unter der folgenden
Internetadresse zur Verfügung:
www.MedtronicCompliance.eu
Par la présente, Medtronic
déclare que cet équipement
radio Modèle 97715 est
conforme à la directive
2014/53/UE. Le texte intégral
de la déclaration de conformité
de l'UE est disponible sur le
site Internet:
www.MedtronicCompliance.eu
Dieses Produkt arbeitet mit
402-405 MHz und einer
effektiven Strahlungsleistung
von weniger als 0.5 μW ERP.
Ce produit fonctionne dans la
bande de 402 à 405 MHz avec
une puissance rayonnée
effective inférieure à 0.5 μW
PRE.
Greek
Croatian
ǻȚĮ IJȠȣ ʌĮȡȩȞIJȠȢ, Ș Medtronic
įȘȜȫȞİȚ ȩIJȚ Ƞ ʌĮȡȫȞ
ȡĮįȚȠİȟȠʌȜȚıȝȩȢ ȝİ ĮȡȚșȝȩ
MȠȞIJȑȜȠȣ 97715 ȕȡȓıțİIJĮȚ ıİ
ıȣȝȝȩȡijȦıȘ ȝİ IJȘȞ OįȘȖȓĮ
2014/53/EǼ. ȉȠ ʌȜȒȡİȢ țİȓȝİȞȠ
IJȘȢ įȒȜȦıȘȢ ıȣȝȝȩȡijȦıȘȢ
ȖȚĮ IJȘȞ ǼȣȡȦʌĮȧțȒ DzȞȦıȘ
İȓȞĮȚ įȚĮșȑıȚȝȠ ıIJȘȞ ĮțȩȜȠȣșȘ
įȚĮįȚțIJȣĮțȒ įȚİȪșȣȞıȘ:
www.MedtronicCompliance.eu
ȉȠ ʌĮȡȩȞ ʌȡȠȧȩȞ ȜİȚIJȠȣȡȖİȓ
ıIJȘ ȗȫȞȘ IJȦȞ 402-405 MHz ȝİ
İȞİȡȖȩ ĮțIJȚȞȠȕȠȜȠȪȝİȞȘ ȚıȤȪ
ȝȚțȡȩIJİȡȘ Įʌȩ 0.5 μW e.r.p.
(İȞİȡȖȩȢ ĮțIJȚȞȠȕȠȜȠȪȝİȞȘ
ȚıȤȪȢ).
Ovime tvrtka Medtronic
izjavljuje da je ova radijska
oprema model 97715 u skladu
s Direktivom 2014/53/EU.
Cjelokupan tekst europske
izjave o sukladnosti dostupan
je na sljedeüoj internetskoj
stranici:
www.MedtronicCompliance.eu
Ovaj proizvod radi pri
frekvenciji 402-405 MHz s
djelotvornom zraþenom
snagom manjom od 0.5 μW
e.r.p.
Hungarian
Spanish
Por la presente, Medtronic
declara que este equipo de
radio, modelo número 97715
cumple la Directiva
2014/53/EU. El texto completo
de la Declaración de
Conformidad CE está
disponible en la siguiente
dirección de internet:
www.MedtronicCompliance.eu
Este producto opera en la
banda de frecuencia de
402-405 MHz con una potencia
radiada efectiva (PRE) de
menos de 0.5 μW.
A Medtronic ezúton
nyilatkozza, hogy ez az 97715
típusszámú rádióberendezés
megfelel a 2014/53/EU
irányelvnek. Az EU
megfelelĘségi nyilatkozat teljes
szövege elérhetĘ a következĘ
internetes címen:
www.MedtronicCompliance.eu
Ez a termék a 402–405 MHzes sávban mĦködik úgy, hogy
tényleges sugárzott
teljesítménye kevesebb, mint
0.5 μW ERP.
Italian
Estonian
Con il presente documento,
Medtronic dichiara che la
presente apparecchiatura radio
modello 97715 è conforme alla
direttiva 2014/53/UE. Il testo
completo della dichiarazione
UE di conformità è disponibile
su Internet al seguente
indirizzo:
www.MedtronicCompliance.eu
Questo prodotto funziona nella
banda a 402–405 MHz con una
potenza irradiata equivalente
inferiore a 0.5 μW ERP.
Lithuanian
Šiuo „Medtronic“ deklaruoja,
kad šis radijo Ƴrangos modelis,
kurio numeris 97715, atitinka
Direktyvą 2014/53/EB. Visą ES
atitikties deklaracijos tekstą
galite rasti šiuo interneto
adresu:
www.MedtronicCompliance.eu
Šis gaminys veikia 402-405
MHz dažnio diapazone,
efektyvi skleidžiama galia yra
mažesnơ nei 0.5 μW ERP.
Latvian
Ar šo uzƼƝmums Medtronic
apliecina, ka šƯ radioiekƗrta,
modeƺa numurs 97715, atbilst
DirektƯvas 2014/53/ES
prasƯbƗm. Pilnu ES atbilstƯbas
deklarƗcijas tekstu var skatƯt
vietnƝ
www.MedtronicCompliance.eu
Šis izstrƗdƗjums darbojas 402–
405 MHz joslƗ, un tƗ efektƯvƗ
izstarotƗ jauda ir mazƗka par
0.5 μW.
Dutch
Hierbij verklaart Medtronic dat
deze radioapparatuur
modelnummer 97715 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 in de 402-405
MHz-band met een effectief
uitgestraald vermogen van
minder dan 0.5 μW e.r.p.
Polish
Firma Medtronic deklaruje
niniejszym, Īe to urządzenie
radiowe, model numer 97715,
speánia wymogi okreĞlone w
Dyrektywie 2014/53/UE. Peány
tekst deklaracji zgodnoĞci UE
jest dostĊpny pod
nastĊpującym adresem
internetowym:
www.MedtronicCompliance.eu
Ten produkt dziaáa w paĞmie
czĊstotliwoĞci 402–405 MHz ze
skuteczną mocą
wypromieniowaną (ERP)
mniejszą niĪ 0.5 μW.
Portuguese
Por este meio, a Medtronic
declara que este modelo de
equipamento de rádio, número
97715, está em conformidade
com a Diretiva 2014/53/UE. O
texto completo da declaração
de conformidade da UE está
disponível no seguinte
endereço da Internet:
www.MedtronicCompliance.eu
Este produto funciona a 402 –
405 MHz com uma potência
irradiada efetiva inferior a 0.5
μW e.r.p.
Romanian
Prin prezenta, Medtronic
declară că acest echipament
radio număr model 97715 este
în conformitate cu Directiva
2014/53/UE. Textul complet al
declara‫܊‬iei de conformitate UE
poate fi găsit la următoarea
adresă de internet:
www.MedtronicCompliance.eu
Acest produs func‫܊‬ionează în
banda 402-405 MHz cu o
putere radiată efectivă de mai
pu‫܊‬in de 0.5 μW E.R.P.
Slovak
SpoloþnosĢ Medtronic týmto
vyhlasuje, že toto rádiové
zariadenie, model 97715, je v
súlade so smernicou
2014/53/EÚ. Úplné znenie
vyhlásenia o zhode so
smernicami EÚ je k dispozícii
na stránke:
www.MedtronicCompliance.eu
Toto zariadenie pracuje vo
frekvenþnom pásme 402 – 405
MHz s efektívnym
vyžarovaným výkonom nižším
ako 0.5 μW ERP.
Slovenian
Družba Medtronic izjavlja, da je
ta radijska oprema, številka
modela 97715, 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 402-405
MHz z uþinkovito moþjo
oddajanja manj kot 0.5 μW
e.m.o. (ERP).
Swedish
Härmed intygar Medtronic att
denna radioutrustning med
modellnummer 97715
överensstämmer med direktiv
2014/53/EU. Den fullständiga
texten med intyg om
överensstämmelse för EU finns
på följande internetadress:
www.MedtronicCompliance.eu
Den här produkten fungerar på
402–405 MHz-bandet med en
effektivt sändningseffekt på
mindre än 0.5 μW e.r.p.
Maltese
Hawnhekk, Medtronic tiddikjara
li dan it-Tagƫmir tar-Radju binnumru tal-mudell 97715 huwa
konformi mad-Direttiva
2014/53/UE. It-test sƫiƫ taddikjarazzjoni ta’ konformità talUE hu disponibbli f’dan lindirizz fuq l-Internet:
www.MedtronicCompliance.eu
Dan il-prodott jopera
fil-402-405 MHz band
b'radiated power effettiv ta'
inqas minn 0.5 μW e.r.p.
௑
Download: 97715 Implantable Neurostimulator ID Label/Location Info M960498A_a_001_view_01 Medtronic, Inc.
Mirror Download [FCC.gov]97715 Implantable Neurostimulator ID Label/Location Info M960498A_a_001_view_01 Medtronic, Inc.
Document ID3393389
Application IDqWmHMQpZY4q9g/AB4tOhMQ==
Document DescriptionFCC ID Alternative Label
Short Term ConfidentialNo
Permanent ConfidentialNo
SupercedeNo
Document TypeID Label/Location Info
Display FormatAdobe Acrobat PDF - pdf
Filesize12.22kB (152808 bits)
Date Submitted2017-05-16 00:00:00
Date Available2017-05-16 00:00:00
Creation Date2016-08-09 12:22:11
Producing SoftwareAcrobat Distiller 15.0 (Windows)
Document Lastmod2017-05-04 15:21:13
Document TitleM960498A_a_001_view_01
Document CreatorAH Formatter V6.2 MR10 (6,2,2015,0721) for Windows
Document Author: whalej1

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