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FR
NORMES
Pour assurer votre sécurité, le stimulateur a été conçu, fabriqué et distribué conformément aux exigences de
la Directive Européenne 93/42/CEE modifiée relative aux dispositifs médicaux.
Le stimulateur est également conforme à la norme CEI 60601-1 relative aux exigences générales de sécurité
pour les dispositifs électromédicaux, à la norme CEI 60601-1-2 sur la compatibilité électromagnétique et
à la norme CEI 60601-2-10 sur les exigences de sécurité particulières pour les stimulateurs nerveux et
musculaires
Conformément aux normes internationales en vigueur, un avertissement doit être donné concernant
l’application des électrodes sur le thorax (augmentation du risque de fibrillation cardiaque).
Le stimulateur est également conforme à la Directive 2002/96/CEE sur les déchets d’équipements
électriques et électroniques (WEEE).
47


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