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Conformiteitsverklaring fabrikant - Elektromagnetische immuniteit
De MiniMed 640G-insulinepomp is bedoeld voor gebruik in de hieronder gespecifi‐
ceerde elektromagnetische omgeving. De gebruiker van de MiniMed-insulinepomp
dient erop toe te zien dat het apparaat in een dergelijke omgeving wordt gebruikt.
Immuniteitstest IEC 60601 Test‐
niveau
Conformiteits‐
niveau
Elektromagnetische
omgeving - leidraad
Statische ontlading
(ESD)
IEC 61000-4-2
±8 kV contact
±15 kV lucht
±30 kV lucht
(< 5% relatieve
luchtvochtig‐
heid)
Voor gebruik in een
normale huishoude‐
lijke, commerciële of
ziekenhuisomgeving.
Snelle elektrische tran‐
siënten en lawines
±2 kV voor net‐
voedingskabels
Niet van toe‐
passing
Deze eis geldt niet
voor dit apparaat op
batterijvoeding.
IEC 61000-4-4 ±1 kV voor
in-/uitgangska‐
bels
Stootspanningen
IEC 61000-4-5
±1 kV tussen de
fasen onderling
±2 kV tussen
fase en aarde
Niet van toe‐
passing
Deze eis geldt niet
voor dit apparaat op
batterijvoeding.
Kortstondige span‐
ningsdalingen en
-onderbrekingen en
spanningsvariaties in
de netvoeding
IEC 61000-4-11
< 5% UT (> 95%
daling in UT)
gedurende
0,5 cyclus
Niet van toe‐
passing
Deze eis geldt niet
voor dit apparaat op
batterijvoeding.
278 Hoofdstuk 15
292


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