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Conformiteitsverklaring fabrikant - Elektromagnetische immuniteit
De MiniMed 640G-insulinepomp is bedoeld voor gebruik in de hieronder gespe‐
cificeerde elektromagnetische omgeving. De gebruiker van de MiniMed-insuline‐
pomp dient erop toe te zien dat het apparaat in een dergelijke
elektromagnetische omgeving wordt gebruikt.
aDe veldsterkte van vaste zenders, zoals basisstations voor mobiele/draadloze telefoons
en mobiele radiozenders, amateurzenders, AM- en FM-radiozenders, tv-zenders, enz.
kan niet nauwkeurig theoretisch worden bepaald. Om de invloed van vaste RF-zenders
op de elektromagnetische omgeving vast te stellen, kan een elektromagnetisch onder‐
zoek ter plaatse noodzakelijk zijn. Als de gemeten veldsterkte op de plaats waar de
MiniMed-insulinepomp wordt gebruikt, hoger is dan het desbetreffende RF-conformi‐
teitsniveau, moet middels observatie worden vastgesteld of de MiniMed-insulinepomp
normaal functioneert. Als abnormaal gedrag wordt waargenomen, kunnen aanvullende
maatregelen noodzakelijk zijn, zoals heroriëntatie of verplaatsing van de MiniMed-insuli‐
nepomp.
bIn het frequentiebereik 150 kHz tot 80 MHz, moet de veldsterkte minder zijn dan
10 V/m.
productspecificaties en veiligheidsinformatie
Productspecificaties en veiligheidsinformatie 281
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