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D-26
• EN 1060-4:2004
Nicht-invasive Blutdruckmessgeräte
Teil 4: Prüfverfahren zur Bestimmung
der Messgenauigkeit
ESH (European Society of Hypertension)
Das Gerät erfüllt die Anforderungen der
klinischen Prüfung des «International Proto-
col for validation of blood pressure measur-
ing devices in adults, 2002“.
• Dieses Produkt hält die Richtlinie
93/42/ EWG des Rates vom 14.Juni
1993 über Medizinprodukte ein
Hersteller:
UEBE Medical GmbH
Zum Ottersberg 9
97877 Wertheim
Germany
Messtechnische Kontrolle
(vormals Eichung)
Generell wird eine messtechnische
Kontrolle im Abstand von 2 Jahren
empfohlen. Fachliche Benutzer sind
allerdings gemäß „Medizinprodukte-
Betreiberverordnung“ dazu angehalten.
Diese kann entweder durch die UEBE
Medical GmbH, eine für das Messwesen
zuständige Behörde oder durch autori-
sierte Wartungsdienste erfolgen.
Zuständige Behörden oder autorisierte
Wartungsdienste erhalten auf Anforde-
rung eine „Prüfanweisung zur mess-
technischen Kontrolle“ vom Hersteller.
G
Anhang
Achtung:
Ohne Erlaubnis des Herstellers dürfen an
diesem Gerät keine Veränderungen, z.B.
Öffnen des Gerätes (ausgenommen Batte-
rieaustausch) vorgenommen werden.
27


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