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Elektromagnetische Störfestigkeit Leitlinien und Herstellererklärung
Die MiniMed 770G Insulinpumpe ist für die Nutzung in der nachfolgend spezifizier‐
ten elektromagnetischen Umgebung vorgesehen. Der Käufer oder Anwender der
MiniMed 770G Insulinpumpe sollte sicherstellen, dass diese in einer solchen Umge‐
bung verwendet wird.
Störfestigkeitsprüfung Prüfpegel nach
IEC 60601
Übereinstim‐
mungspegel
Elektromagnetische
Umgebung Leitli‐
nien
Elektrostatische Entla‐
dung (ESD)
IEC 61000-4-2,
60601-1-2
±8 kV Kontakt
±2, 4, 8, 15 kV
(Luft)
±8 kV (Kontakt)
±2, 4, 8, 15 kV
(Luft)
Zur Verwendung in
einer typischen häusli‐
chen, gewerblichen
oder klinischen Umge‐
bung.
Leitungsgeführte Stör‐
größen durch HF-Fel‐
der
3 Veff
150 kHz bis
80 MHz
6 Veff
ISM-Bänder zwi‐
schen
150 kHz und 80
MHz
Nicht anwend‐
bar
Die Anforderung gilt
nicht für dieses batte‐
riebetriebene Gerät.
Schnelle elektrische
Transienten/Stoßspan‐
nungen
IEC 61000-4-4
±2 kV
100 kHz Wiede‐
rholungsfre‐
quenz
Nicht anwend‐
bar
Die Anforderung gilt
nicht für dieses batte‐
riebetriebene Gerät.
Spannungsstoß
IEC 61000-4-5
Leitung-zu-Lei‐
tung: ±0,5 kV,
±1 kV
Leitung-zu-Erde:
±0,5 kV, ±1 kV
und ±2 kV
Nicht anwend‐
bar
Die Anforderung gilt
nicht für dieses batte‐
riebetriebene Gerät.
354 Kapitel 16
370


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