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Elektromagnetische Störfestigkeit Leitlinien und Herstellererklärung
Die Insulinpumpe MiniMed 780G ist für die Nutzung in der nachfolgend spezifizier‐
ten elektromagnetischen Umgebung vorgesehen. Der Käufer oder Anwender der
Insulinpumpe MiniMed 780G sollte sicherstellen, dass diese in einer solchen elektro‐
magnetischen Umgebung verwendet wird.
Störfestig‐
keitstest
Prüfpegel
nach
IEC 60601-1-
2
Übereinstim‐
mungspegel
Elektromagnetische Umgebung
Leitlinien
Abgestrahlte
HF
IEC
61000-4-3
IEC
60601-1-2
EN 301
489-17
10 V/m
80 MHz bis
2,7 GHz
80 % AM bei
1 kHz
10 V/m
80 MHz bis
2,7 GHz
80 % AM bei
1 kHz
Der Abstand zwischen tragbaren und
mobilen HF-Kommunikationsgeräten
und der Insulinpumpe MiniMed 780G
(sämtliche Komponenten des Geräts
einschließlich etwaiger Verbindungska‐
bel) darf den empfohlenen Mindestab‐
stand von 30 cm (12 Zoll) nicht
unterschreiten.
Die von ortsfesten HF-Sendern hervor‐
gerufenen Feldstärken, wie sie durch
eine elektromagnetische Standortauf‐
nahme bestimmt werden, müssen in
jedem Frequenzbereich unter dem
Übereinstimmungspegel liegen.
In der näheren Umgebung von Gerä‐
ten, die mit dem folgenden Zeichen
gekennzeichnet sind, können Störun‐
gen auftreten:
Anhang B
Produktspezifikationen 335
351


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