Barco BDEM-01, Руководство пользователя

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K5902200 /07 Barco Demetra 54
Le présent appareil est conforme aux CNR d' ISED 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.
Permitted frequency ranges - Gamme de fréquences autorisée
Operations in the 5.25-5.35 GHz band are restricted to indoor usage only.
Les opérations dans la bande de 5.25-5.35 GHz sont limités à un usage intérieur seulement.
Operation in the band 5150-5250 MHz is only for indoor use to reduce the potential for harmful interference to
co-channel mobile satellite systems.
La bande 5 150-5 250 MHz est réservés uniquement pour une utilisation à l'intérieur afin de réduire les
risques de brouillage préjudiciable aux systèmes de satellites mobiles utilisant les mêmes canaux.
For the frequency 5600-5650 MHz, no operation is permitted.
Pour la fréquence 5600-5650 MHz, aucune opération est autorisée.
Radiation exposure statement
These requirements set a SAR limit of 1.6 W/kg averaged over one gram of tissue. The highest SAR value
reported under this standard during product certification for use when properly worn on the body is 1.148 W/
kg.
Ces exigences établissent une limite SAR de 1,6 W/kg en moyenne sur un gramme de tissu. La valeur SAR la
plus élevée déclarée selon cette norme lors de la certification du produit à utiliser lorsqu'il est correctement
porté sur le corps est de 1.148 W/kg.
8.3.4 General information
Notice to the user and/or patient
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the
competent authority of the Member State in which the user and/or patient is established.
Manufacturing country
The manufacturing country of the product is indicated on the product label ( “ Made in …” ).
Importers contact information
To find your local importer, contact one of Barco ’ s regional offices via the contact information provided on our
website ( www.barco.com ).
8.4 Integration of Demetra in IT networks
About
The organization, incorporation Demetra in an IT network, shall have the policies, processes and standards in
place to incorporate and support a medical device into its IT network. This shall include the application of risk
management (e.g. by following IEC 80001-1:2010 or equivalent standards).
Information provided in this section shall be provided to the responsible incorporating the Demetra Scope into
the IT network.
Integration of the Demetra Scope
• The Demetra Scope requires a secure WiFi access point in the IT network, supporting the standards
802.11 abgn ac (2.4 GHz or 5 GHz) for network connectivity to the Demetra Cloud.
• This WiFi access point shall support 802.11h with Dynamic Frequency Selection (DFS) and Transmit
Power Control (TPC).
• The Demetra Scope requires a 'Broadband' connectivity to the Demetra Cloud (located either in the
Amazon AWS EU West region in Ireland or the AWS US East region in N. Virginia depending on account
onboarding) of at least 30 Mb/s download speed and 15 Mb/s upload speed over the WiFi network in use.
Important information