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LifeScan One Touch Vita Bloedglucosesysteem Manual

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27
PROBLEMEN OPLOSSEN EN GEDETAILLEERDE INFORMATIE OVER HET SYSTEEM
Elektriciteits- en veiligheidsnormen
Deze meter voldoet aan CISPR 11: 2003, klasse B (uitsluitend uitstraling). De toegepaste energie-emissies zijn zo laag dat het niet
waarschijnlijk is dat deze storingen zullen opleveren in elektronische apparatuur in de nabije omgeving. De meter is getest op
immuniteit voor elektrostatische ontladingen op niveau 3 zoals gespeciceerd in IEC 61000-4-2. Deze meter is getest op immuniteit
voor radiofrequentiestoring binnen het frequentiebereik van 80 MHz tot 2,5 GHz bij 3 V/m zoals gespeciceerd in IEC 61000-4-3.
Kwalicatie voor beschermingsgraad: IP31
Garantie
LifeScan garandeert de OneTouch® Vita® meter gedurende drie jaar na de aankoopdatum (materiaal- en montagefouten). De garantie
geldt uitsluitend voor de oorspronkelijke koper en is niet overdraagbaar.
Nauwkeurigheid
Binnen een meetreeks (100 tests met
veneus bloed per glucosewaarde)
Totale nauwkeurigheid (200 tests met
controlevloeistof per glucosewaarde)
Doelniveau
glucose
(mmol/L)
Gemiddelde
glucose
(mmol/L)
Standaard
afwijking
(mmol/L)
Coëciënt
variatie (%)
2,2 2,2 0,1 3,5
5,6 5,7 0,1 1,7
7,2 7,7 0,1 1,9
11,1 12,7 0,2 1,3
16,7 19,6 0,3 1,5
Glucose-
niveaus
(mmol/L)
Gemiddelde
glucose
(mmol/L)
Standaard
afwijking
(mmol/L)
Coëciënt
variatie (%)
LAAG 2,2 0,1 3,3
NORMAAL 6,1 0,1 1,8
HOOG 19,6 0,3 1,5
De resultaten tonen aan dat de grootste
waargenomen variabiliteit tussen met
bloed geteste teststrips 3,5% of minder is.
06640801A_OTVTA_UG_NL_nl_R4_web.indd 27 8/24/09 5:53:24 PM
… 32


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