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6. Technische Daten
DE
Hinweise:
Änderung dieser technischen Daten ohne Ankündigung vorbehalten.
In der klinischen Validierungsstudie wurde K5 zur Messung des diastolischen Blutdrucks bei 85
Probanden verwendet.
Dieses Gerät wurde gemäß den Anforderungen der ISO 81060-2:2013 klinisch getestet.
Das Gerät ist nicht zur Verwendung bei Schwangeren validiert worden.
Die IP-Klassifizierung gibt den Schutzgrad von Gehäusen gemäß IEC 60529 an. Dieses Gerät ist vor
festen Fremdkörpern mit einem Durchmesser von 12 mm und mehr – etwa einem Finger – geschützt.
Dieses Gerät entspricht den Bestimmungen der EG-Richtlinie 93/42/EWG (Richtlinie für
medizinische Geräte).
Dieses Messgerät wurde gemäß der europäischen Norm EN1060 entwickelt.
Nichtinvasive Blutdruckmessgeräte Teil 1: Allgemeine Anforderungen und Teil 3:
Ergänzende Anforderungen für elektromechanische Blutdruckmessgeräte.
Dieses OMRON-Messgerät wurde unter Einhaltung des strengen Qualitätssystems von
OMRON HEALTHCARE Co., Ltd., Japan, hergestellt. Das Herzstück für OMRON-
Messgeräte, der Drucksensor, wird in Japan hergestellt.
Manschetten-/Schlauchmaterial Nylon, Polyester, Polyvinylchlorid
Inhalt Messgerät, Manschette, Gebrauchsanweisung, Aufbewahrungsbox,
Batterien, Blutdruckpass, Anweisungen zur Installation
41


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