Medtronic 8637 Regulatory Statements

8637 Communications Regulation
Reference Sheet

Manufacturer

Medtronic, Inc.
710 Medtronic Parkway,
Minneapolis, MN 55432-5604,
USA
www.medtronic.com
Tel. [phone]

Authorized Representative
in the European Community

Medtronic B.V.
Earl Bakkenstraat 10,
6422 PJ Heerlen,
The Netherlands
Tel. [phone]

Europe/Africa/Middle East Headquarters

Medtronic International Trading Sàrl
Route du Molliau 31,
Case Postale 84
CH - 1131 Tolochenaz,
Switzerland
www.medtronic.eu
Tel. [phone]

Asia-Pacific

Medtronic International Ltd.
Suite 1106-11, 11/F, Tower 1, The Gateway,
25 Canton Road, Tsimshatsui,
Kowloon,
Hong Kong
Tel. [phone]

*M962271A002*

REP

EC

© Medtronic, Inc. 2017

All Rights Reserved

M962271A002 Rev A

 2018-04-01

Communications Regulations

The following is a list of communications regulations that apply
to the Model 8637.

United States Compliance

FCC ID: LF58637

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 d’Industrie Canada.
Son exploitation est autorisée à
condition que l’appareil ne
produise pas de brouillage
préjudiciable et qu’il accepte
tout brouillage, même celui
susceptible d’en compromettre
le fonctionnement.

This product operates at 175
kHz with an H-field strength of
less than 30 dBµA/m at 10 m.

Ce produit fonctionne à 175
kHz avec une intensité de
champ H inférieure à 30
dBµA/m à 10 m.

Argentina Compliance

CNC ID: H-17434

CNC ID: H-17433

This product conforms to
Argentina Radio Requirements.

Este producto cumple los
requisitos de Argentina
relativos a la radioelectricidad.

Brazil Compliance

4876-15-5567

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.

HIDF15000146

Korea Compliance

MSIP-RMI-MKL-8637

This radio device has
possibility of radio interference
during operation.

해당무선설비기기는 운용 중 전
파혼신가능성이 있음.

Singapore Compliance

Dealer License # DA103452

This product complies with IDA
Standards.

该产品符合IDA标准。

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.

Philippines Compliance

ESD-1715923C

ESD-1715922C

This product conforms to
Philippines Radio
Requirements.

Taiwan Compliance

CCAF17LP0170T7

According to "Administrative
Regulations on Low Power
Radio Waves Radiated
Devices" Without permission
granted by the NCC, any
company, enterprise, or user is
not allowed to change
frequency, enhance
transmitting power or alter
original characteristic as well
as performance to an approved
low power radio-frequency
devices. The low power radio­frequency devices shall not
influence aircraft security and
interfere legal communications;
If found, the user shall cease
operating immediately until no
interference is achieved. The
said legal communications
means radio communications
is operated in compliance with
the Telecommunications Act.
The low power radio-frequency
devices must be susceptible
with the interference from legal
communications or ISM radio
wave radiated devices.

經型式認證合格之低功率射頻電
機，非經許可，公司、商號或使
用者均不得擅自變更頻率、加大
功 率或變更原設計之特性及 功
能。低功率射頻電機之使用不得
影響飛航安全及干擾合法通信；
經發現 有干擾現象時，應立即
停用，並改善至無干擾時方得繼
續使用。前項合法通信，指依電
信法規定作 業之無線電通信。

低功率射頻電機須忍受合法通信
或工業、科學及醫療用電波輻射
性電機設備之干擾.

European Union Compliance

Conformité Européenne
(European Conformity)

Hereby, Medtronic declares
that this Radio Equipment
model number 8637 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 dBµA/m at 10 m.

Bulgarian

С настоящото Medtronic
декларира, че това
радиооборудване модел
номер 8637 е в съответствие
с Директива 2014/53/ЕС.
Пълният текст на ЕС
декларацията за
съответствие е на
разположение на следния
интернет адрес:

www.MedtronicCompliance.eu

Този продукт работи при 175
kHz със сила на поле H под
30 dBµA/m на 10 м.

Czech

Společnost Medtronic tímto
prohlašuje, že toto radiové
zařízení, číslo modelu 8637,
odpovídá požadavkům
směrnice 2014/53/EU. Úplný
text EU Prohlášení o shodě
k dispozici na následující
internetové adrese:
www.MedtronicCompliance.eu

Tento výrobek používá
frekvenci 175kHz, přičemž
intenzita pole H je nižší než 30
dBµA/m ve vzdálenosti 10m.

Danish

Medtronic erklærer hermed, at
dette radioudstyr
modelnummer 8637 er i
overensstemmelse med
direktiv 2014/53/EU. Den fulde
tekst i EU­overensstemmelseser­klæringen kan læses her:
www.MedtronicCompliance.eu

Dette produkt fungerer ved 175
kHz med en H-feltstyrke på
mindre end 30 dBµA/m ved 10
m.

German

Hiermit erklärt Medtronic, dass
dieses Funkgerätmodell Nr.
8637 der Richtlinie 2014/53/EU
entspricht. Der vollständige
Text der EU­Konformitätserklärung steht
unter der folgenden
Internetadresse zur Verfügung:
www.MedtronicCompliance.eu

Dieses Produkt arbeitet mit 175
kHz und einer H-Feldstärke
von weniger als 30 dBµA/m in
einer Entfernung von 10 m.

Greek

je

∆ια του παρόντος, η Medtronic
δηλώνει ότι ο παρών
ραδιοεξοπλισμός με αριθμό
Mοντέλου 8637 βρίσκεται σε
συμμόρφωση με την Oδηγία
2014/53/EΕ. Το πλήρες κείμενο
της δήλωσης συμμόρφωσης
για την Ευρωπαϊκή Ένωση
είναι διαθέσιμο στην ακόλουθη
διαδικτυακή διεύθυνση:

www.MedtronicCompliance.eu

προϊόν λειτουργεί

Το παρόν
στα 175 kHz με ένταση
μαγνητικού πεδίου «H»
μικρότερη από 30 dBµA/m στα

10 m.

Spanish

Por la presente, Medtronic
declara que este equipo de
radio, modelo número 8637
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 a 175 kHz
con una intensidad de campo
H de menos de 30 dBµA/m a
10 m.

Estonian

Käesolevaga kinnitab
Medtronic, et see
raadioseadmestik
mudelinumbriga 8637 on
vastavuses direktiiviga
2014/53/EL. Kogu EL-i
vastavusdeklaratsiooni tekst on
saadaval järgmisel
internetiaadressil:
www.MedtronicCompliance.eu

See toode töötab sagedusel
175 kHz H-välja tugevusega
vähem kui 30 dBµA/m 10 m
juures.

Finnish

Medtronic vakuuttaa täten, että
tämä radiolaite, mallinumero
8637, vastaa direktiiviä
2014/53/EU. EU­vaatimustenmukaisuus­vakuutuksen koko teksti on
saatavissa seuraavasta
Internet-osoitteesta:
www.MedtronicCompliance.eu

Tämä tuote toimii 175 kHz:n
taajuudella, ja sen H-kentän
voimakkuus on alle 30 dBµA/m
10 m:n etäisyydellä.

French

Par la présente, Medtronic
déclare que cet équipement
radio Modèle 8637 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

Ce produit fonctionne à 175
kHz avec une intensité de
champ H inférieure à 30
dBµA/m à 10 m.

Croatian

Ovime tvrtka Medtronic
izjavljuje da je ova radijska
oprema model 8637 u skladu s
Direktivom 2014/53/EU.
Cjelokupan tekst europske
izjave o sukladnosti dostupan
je na sljedećoj internetskoj

stranici:
www.MedtronicCompliance.eu

Ovaj proizvod radi pri
frekvenciji od 175 kHz sa
snagom H polja manjom od 30
dBµA/m pri 10 m.

Hungarian

A Medtronic ezúton
nyilatkozza, hogy ez az 8637
típusszámú rádióberendezés
megfelel a 2014/53/EU
irányelvnek. Az EU
megfelelőségi nyilatkozat teljes
szövege elérhető a következő
internetes címen:
www.MedtronicCompliance.eu

Ez a termék 175 kHz-en úgy
működik, hogy mágneses
térerőssége 10 m távolságban
kevesebb, mint 30 dBµA/m.

Italian

Con il presente documento,
Medtronic dichiara che la
presente apparecchiatura radio
modello 8637 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 a
175 kHz con intensità di campo
H inferiore a 30 dBµA/m a 10
m.

Lithuanian

Šiuo „Medtronic“ deklaruoja,
kad šis radijo įrangos modelis,
kurio numeris 8637, atitinka
Direktyvą 2014/53/EB. Visą ES
atitikties deklaracijos tekstą
galite rasti šiuo interneto
adresu:
www.MedtronicCompliance.eu

Šis gaminys veikia 175 kHz
dažniu, kai H lauko stiprumas
yra mažesnis nei 30 dBµA/m
10 m atstumu.

Latvian

Ar šo uzņēmums Medtronic
apliecina, ka šī radioiekārta,
modeļa numurs 8637, atbilst
Direktīvas 2014/53/EK
prasībām. Pilnu ES atbilstības
deklarācijas tekstu var skatīt
vietnē
www.MedtronicCompliance.eu

Šis izstrādājums darbojas ar
175 kHz frekvenci, un 10 metru
attālumā tā magnētiskā lauka
stiprums ir mazāks par 30
dBµA/m.

Dutch

Hierbij verklaart Medtronic dat
deze radioapparatuur
modelnummer 8637 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 dBµA/m bij 10
m.

Polish