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norme harmonisée couvrant les exigences essentielles de l'article3.2 de la
directive R&TTE
EN 301 489-1-3 V1.9.2:2011 compatibilité électromagnétique et spectre
radioélectrique (ERM); norme de compatibilité électromagnétique pour les
services et équipements de communications radio; partie1: exigences
techniques communes
EN 301 489-1-17 V2.2.1:2012 compatibilité électromagnétique et spectre
radioélectrique (ERM); norme de compatibilité électromagnétique pour les
services et équipements de communications radio; partie1: exigences
techniques communes
EN 60601-1-2:2007/AC 2010: équipements électriques médicaux: partie
1–2: exigences générales pour la sécurité de base et les performances essentielles
–Norme collatérale: compatibilité électromagnétique
EN 55011 Groupe1 ClasseB: 2009+A1:2010: équipements industriels,
scientifiques et médicaux (ISM) - Caractéristiques de perturbations radio
(RF)– Limites et méthodes de mesure
FCC partieB 15B:2013 Compatibilité électromagnétique
Règle FCC partie: 15.247 Cat.: DSS (Bluetooth) Règle FCC partie: 15.247
Cat.: DTS (BT4.0)
ENISO 10993-1:2009 Évaluation biologique des dispositifs médicaux – Partie
1: évaluation et essais dans le cadre d'un processus de gestion du risque (ISO
10993-1:2009)
ANSI/AAMI SP10: 2002/A1 2003(R) 2008: tensiomètres manuels,
électroniques ou automatisés
ANSI/AAMI/ISO 81060-2:2009 Tensiomètres non invasifs – Partie2:
validation clinique du type de mesure automatisée
DÉCLARATION DE LA FCC
Federal Communications Commission (FCC) Statement 15.21
You are cautioned that changes or modifications not expressly approved by the
part responsible for compliance could void the user’s authority to operate the
equipment.
15.105(b)
This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC rules. These limits are designed to
provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception,
which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following
measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.
27


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