Canon BM70659 User's Manual of End Product

9. Regulatory information
EN 60601-1-4:1996+A1:1999 Medical electrical equipment - Part 1-4:Collateral
Standard:Programmable electrical medical systems
EN 60601-1-6:2007 Medical electrical equipment - Part 1-6:Collateral Standard:Usability
EN 60601-2-32:1994 Medical electrical equipment - Part 2: Particular requirements for the
safety of associated equipment of X-ray equipment
EN 62304:2006 Medical device software-Software life cycle processes
EN 62366:2008 Medical device - Application of usability engineering to medical
devices
EN ISO 14971:2009 Medical device - Application of risk management to medical devices
EN ISO 10993-1:2009/-5:2009/ 10993-10:2009
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
9-2. Radio frequency (RF) compliance information
U.S.A. FCC Part 15 Subpart B Class A and Part 15 Subpart C/E
(RF Exposure).
Canada RSS-210
European Union (and EEA) ETSI EN300 328
ETSI EN301 489 ETSI EN301 893
Singapore IDA TS SRD
FCC compliance (For U.S.A.)
Contains FCC ID:AZDBM70659
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.
FCC WARNING:
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
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.
5.15-5.25GHz band is restricted to indoor operations only.
This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.
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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.
9. Regulatory information
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 findings have not been confirmed by additional research. CXDI-•••••• Wireless has been tested and found to comply with FCC radiation exposure limits set forth for an uncontrolled equipment and meets the FCC radio frequency (RF) Exposure Guidelines in Supplement C to OET65.
IC compliance (For Canada)
Contains IC:498J-BM70659
This device complies with Industry Canada licence-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 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'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.
5.15-5.25GHz band is restricted to indoor operations only.
La bande 5 150-5 250 MHz est restreints à une utilisation à l'intérieur.
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 of 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 findings have not been confirmed by additional research. CXDI-•••••• Wireless has been tested and found to comply with IC radiation exposure limits set forth for an uncontrolled environment and meets RSS-102 of the IC radio frequency (RF) Exposure rules.
Les connaissances scientifiques dont nous disposons n'ont mis en évidence aucun problème de santé associé à l'usage des appareils sans fil à faible puissance. Nous ne sommes cependant pas en mesure de prouver que ces appareils sans fil à faible puissance sont entièrement sans danger. Les appareils sans fil à faible puissance émettent une énergie radioélectrique (RF) très faible dans le spectre des micro-ondes lorsqu'ils sont utilisés. Alors qu'une dose élevée de RF peut avoir des effets sur la santé (en chauffant les tissus), l'exposition à de faibles RF qui ne produisent pas de chaleur n'a pas de mauvais effets connus sur la santé. De nombreuses études ont été menées sur les expositions aux RF faibles et n'ont découvert aucun effet biologique. Certaines études ont suggéré qu'il pouvait y avoir certains effets biologiques, mais ces résultats n'ont pas été confirmés par des recherché supplémentaires. CXDI-•••••• Wireless a été testé et jugé conforme aux limites d'exposition aux rayonnements énoncées pour un environnement non contrôlé et respecte les règles d'exposition aux fréquences radioélectriques (FR) RSS-102 de l'IC.
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