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6. Specificaties
NL
Opmerkingen:
Deze specificaties kunnen zonder kennisgeving worden gewijzigd.
In de klinische validatiestudie is de vijfde fase gebruikt bij 85 personen voor het bepalen van de
diastolische bloeddruk.
Dit apparaat is niet gevalideerd voor gebruik bij zwangere patiënten.
• Dit apparaat voldoet aan de voorwaarden van EG-Richtlijn 93/42/EEG betreffende medische
hulpmiddelen.
Dit apparaat is ontworpen volgens de Europese standaard EN1060, niet-invasieve
sfingomanometer deel 1: Algemene vereisten en deel 3: Aanvullende vereisten voor
elektromechanische bloeddrukmeetsystemen.
Dit OMRON-apparaat is vervaardigd conform het strenge kwaliteitssysteem van
OMRON HEALTHCARE Co. Ltd., Japan. De hoofdcomponent voor OMRON-bloeddrukmeters,
de druksensor, wordt geproduceerd in Japan.
32


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