Canon BM70432 User Manual

9. Regulatory and safety information

EN 60601-1-32:1994 (Particular requirements for the safety of associated equipment of X-
ray equipment)
EN ISO 14971:2000+A1:2003 (Risk management to medical devices)
EN ISO 10993-1:2003/-5:1999/10993-10:2002+A1:2006 (Biological evaluation of medical
devices - Evaluation and testing)
EN IEC 62304 (Medical device software life cycle processes)
EN IEC 62366 (Usability)
RoHS (Restriction of Hazardous Substances)
WEEE (Waste Electrical and Electronic Equipment Directive)

9-2. Radio frequency (RF) compliance information

Declaration of conformity

U.S.A. FCC Part 15 Subpart B Class A and Part 15 Subpart C

(RF Exposure).
Canada RSS-210
European Union (and EEA) ETSI EN300 328-1,-2 (Emission)

ETSI EN301 489-1.-17 (Immunity)
Australia AS4268
Singapore IDA TS-14

 For U.S.A. and Canada

• FCC/IC compliance

This device complies with Part 15 of the FCC Rules and RSS-Gen of IC Rules.
Operation is subject to the following two conditions:

1. This device may not cause harmful interference.

2. This device must accept any interference received, including interference that
may cause undesired operation.

Note: This equipment has been tested and found to comply with the limits for a Class

A digital device, pursuant to part 15 of the FCC Rules. These limits are designed
to provide reasonable protection against harmful interference when the
equipment is operated in a commercial environment. This equipment generates,
uses, and can radiate radio frequency energy and, if not installed and used in
accordance with the instruction manual, may cause harmful interference to radio
communications. Operation of this equipment in a residential area is likely to
cause harmful interference in which case the user will be required to correct the
interference at his own expense.

FCC WARNING:

Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.

This transmitter must not be co-located or operated in conjunction with any other
antenna or transmitter.

RF exposure compliance

The available scientific evidence does not show that any health problems are
associated with using low power wireless devices. There is no proof, however, that
these low power wireless devices are absolutely safe. Low power wireless devices emit
low levels radio frequency energy (RF) in the microwave range while being used.
Whereas high levels of RF can produce health effects (by heating tissue), exposure of
low-level RF that does not produce heating effects causes no known adverse health
effects. Many studies of low-level RF exposures have not found any biological effects.
Some studies have suggested that some biological effects might occur, but such

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9. Regulatory and safety information

findings have not been confirmed by additional research. CXDI-70C Wireless has been
tested and found to comply with FCC/IC radiation exposure limits set forth for an
uncontrolled equipment and meets the FCC radio frequency (RF) Exposure Guidelines
in Supplement C to OET65 and RSS-102 of the IC radio frequency (RF) Exposure rules.

 For European Union (and EEA)

English

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Eesti

Español

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Hereby, Canon Inc., declares that this CXDI-70C Wireless is in compliance
with the essential requirements and other relevant provisions of Directive
1999/5/EC.

Canon Inc. tímto prohlašuje, že tento CXDI-70C Wireless je ve shodě se

základními požadavky a dalšími příslušnými ustanoveními směrnice 1999/5/
ES.

Undertegnede Canon Inc. erklærer herved, at følgende udstyr CXDI-70C
Wireless overholder de væsentlige krav og øvrige relevante krav i direktiv
1999/5/EF.

Hiermit erklärt Canon Inc., dass sich das Gerät CXDI-70C Wireless in
Übereinstimmung mit den grundlegenden Anforderungen und den übrigen
einschlägigen Bestimmungen der Richtlinie 1999/5/EG befindet.

Käesolevaga kinnitab Canon Inc. seadme CXDI-70C Wireless vastavust
direktiivi 1999/5/EÜ põhinõuetele ja nimetatud direktiivist tulenevatele teistele
asjakohastele sätetele.

Por medio de la presente Canon Inc. declara que el CXDI-70C Wireless
cumple con los requisitos esenciales y cualesquiera otras disposiciones
aplicables o exigibles de la Directiva 1999/5/CE.

ΜΕ ΤΗΝ ΠΑΡΟΥΣΑ Canon Inc. ∆ΗΛΩΝΕΙ ΟΤΙ CXDI-70C Wireless
ΣΥΜΜΟΡΦΩΝΕΤΑΙ ΠΡΟΣ ΤΙΣ ΟΥΣΙΩ∆ΕΙΣ ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ ΛΟΙΠΕΣ
ΣΧΕΤΙΚΕΣ ∆ΙΑΤΑΞΕΙΣ ΤΗΣ Ο∆ΗΓΙΑΣ 1999/5/ΕΚ.

Par la présente Canon Inc. déclare que l’appareil CXDI-70C Wireless est
conforme aux exigences essentielles et aux autres dispositions pertinentes de
la directive 1999/5/CE.

Con la presente Canon Inc. dichiara che questo CXDI-70C Wireless è
conforme ai requisiti essenziali ed alle altre disposizioni pertinenti stabilite
dalla direttiva 1999/5/CE.

Ar šo Canon Inc. deklare, ka CXDI-70C Wireless atbilst Direktivas 1999/5/EK
butiskajam prasibam un citiem ar to saistitajiem noteikumiem.

32

Lietuviu

Nederlands

Malti

Magyar

Polski

Português

Slovensko

Šiuo Canon Inc. deklaruoja, kad šis CXDI-70C Wireless atitinka esminius
reikalavimus ir kitas 1999/5/EB Direktyvos nuostatas.

Hierbij verklaart Canon Inc. dat het toestel CXDI-70C Wireless in
overeenstemming is met de essentiële eisen en de andere relevante
bepalingen van richtlijn 1999/5/EG.

Hawnhekk, Canon Inc., jiddikjara li dan CXDI-70C Wireless jikkonforma mal-
htigijiet essenzjali u ma provvedimenti ohrajn relevanti li hemm fid-Dirrettiva
1999/5/EC.

Alulírott, Canon Inc. nyilatkozom, hogy a CXDI-70C Wireless megfelel a
vonatkozó alapvetõ követelményeknek és az 1999/5/EC irányelv egyéb
elõírásainak.

Niniejszym Canon Inc. oswiadcza, ze CXDI-70C Wireless jest zgodny z
zasadniczymi wymogami oraz pozostalymi stosownymi postanowieniami
Dyrektywy 1999/5/EC.

Canon Inc. declara que este CXDI-70C Wireless está conforme com os
requisitos essenciais e outras disposições da Directiva 1999/5/CE.

Canon Inc. izjavlja, da je ta CXDI-70C Wireless v skladu z bistvenimi
zahtevami in ostalimi relevantnimi dolocili direktive 1999/5/ES.