C
Compliance
Standardscompliance
Thesystemcomplieswiththefollowingstandards.
●IEC60601-1:2012
●IEC60601-1-2:2007
●IEC60601-1-6:2013
●IEC60601-1-8:2012
●IEC60601-2-27:2011
●IEC60601-2-34:2011
●IEC60601-2-49:2011
●IEC62304:2015
●IEC62366:2014
●IEC80601-2-30:2013
●ISO80601-2-55:2011
●ISO80601-2-56:2009
●ISO80601-2-61:2011
Compliancetoparameterandfunctionspecicstandardsisdisclosedintheapplicable
sections.
IEC60601-1
●Typeofprotectionagainstelectricalshock:ClassII.
●Degreeofprotectionagainstelectricalshock:appliedpartsaremarkedwitha
symbolindicatingdegreeofprotection.
●Degreeofsafetyofapplicationinthepresenceofammableanestheticmixture
withairorwithoxygenornitrousoxide:Notsuitable.
WARNING
EXPLOSION.Donotusethisequipmentinthepresenceof
ammableanesthetics,vaporsorliquids.
●Degreeofenclosureprotectionagainstsolidobjectsandwateringressratingsare
speciedintheDesign,environmental,andphysicalspecicationsappendix.
●Modeofoperation:Continuous.
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CARESCAPE ONE User Manual DRAFT 26 October 2017