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80-0062-11-MO-RevB 2018-5-16 SunTech Oscar 2 Gebruikershandleiding | 9
Maximale inflatiedruk
280 mmHg
Nauwkeurigheid
Hartslag nauwkeurig binnen +/-2% of +/-3 bpm, afhankelijk van welke groter is.
Bloeddrukresultaten voldoen aan de ANSI/AAMI/ISO 81060-2:2013-normen voor niet-
invasieve nauwkeurigheid of overtreffen deze:
±5 mmHg gemiddelde fout en 8 mmHg standaarddeviatie.
Validaties
Klinisch gevalideerd volgens het internationale protocol van het ESH, BHS (A/A) en
ANSI/AAMI/ISO 81060-2:2013
Bedieningsomstandigh
eden
Verzend- en
opslagomstandigheden
10°C tot 50°C
20-95% relatieve luchtvochtigheid, niet-condenserend
-20°C tot 70°C
15-95% relatieve luchtvochtigheid, niet-condenserend
Bescherming tegen
indringend water (IP)
Gewone apparatuur, geen bescherming tegen indringend water, IPX0.
Classificatie
Continu werking
Voeding: Twee (2) AA-batterijen
Datageheugen
Flashgeheugen voor maximaal 250 meetwaarden
Aanbeveling voor
kalibratie:
Minstens eenmaal per twee jaar
Veiligheidssystemen
Maximale inflatiedruk beperkt tot 300 mmHg; automatische veiligheidsklep voor
stroomstoring; maximale meettijd beperkt tot 140 seconden
Meetperioden
24 onafhankelijk van elkaar te programmeren perioden (opties voor tijdsintervallen: geen, 5,
10, 15, 20, 30, 45, 60, 90 en 120 minuten)
Parameter
Standaard
EU-norm
Veiligheid
AAMI/ANSI ES60601-1:2005/(R) 2012
+A1:2012
EN 60601-1 :2006/A1:2013/ IEC 60601-1:
2005/A1:2012
Bloeddruk
IEC 80601-2-30 :2009 + A1:2013
n.v.t.
Bruikbaarheid
IEC 60601-1-6 :2010+A1:2013
EN 60601-1-6 :2010
IEC 62366:2015 Ed. 1.0
EN 62366:2008
EMC/EMI/ESD
IEC60601-1-2:2007/(R)2012
EN 60601-1-2:2007
Thuisgebruik
IEC 60601-1-11:2010 Ed. 1.0
EN IEC 60601-1-11:2010
Biocompatibiliteit
ISO 10993-1:2009/(R)2013
EN ISO 10993-1:2009/AC:2010
ISO 10993-5:2009
EN ISO 10993-5:2009
9


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