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Technische gegevens
229
Elektromagnetische
compatibiliteit
Dit apparaat voldoet aan de eisen m.b.t. de elektromagnetische storingsgevoeligheid
conform NEN-EN-ISO 15197 Annex A. De testen voor de storingsgevoeligheid
(m.b.t elektrostatische ontlading) werden uitgevoerd op basis van de basisnorm
IEC 61000-4-2.
Daarnaast voldoet het aan de eisen m.b.t. elektromagnetische straling conform
EN 61326. De elektromagnetische emissie is dienovereenkomstig gering. Een storing
door andere elektrische apparatuur is niet te verwachten.
Specicaties De specicaties van het Accu-Chek Mobile-systeem (Accu-Chek Mobile-meter met
Accu-Chek Mobile-testcassette) zijn bepaald met capillair bloed van mensen met
diabetes (methodenvergelijking, nauwkeurigheid), veneus bloed (herhaalbaarheid) en
controleoplossing (reproduceerbaarheid). Het systeem is gekalibreerd met veneus
bloed met verschillende glucoseconcentraties. De referentiewaarden hiervan zijn
bepaald met de hexokinase-methode. Voor de methodenvergelijking werden de meet-
waarden vergeleken met de meetwaarden verkregen met de hexokinase-methode met
onteiwitten (analyseautomaat). De hexokinase-methode is herleidbaar tot een NIST-
standaard.
Het Accu-Chek Mobile-bloedglucosemeetsysteem voldoet aan de eisen gesteld in NEN-EN-ISO 15197.
Hierbij verklaart Roche Diagnostics, dat de Accu-Chek Mobile-bloedglucosemeter voldoet aan de basale eisen en
de overige van toepassing zijnde bepalingen van richtlijn 1999/5/EG. De overeenstemmingsverklaring vindt u op
het volgende Internetadres: http://mobile.accu-chek.com.
229


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