Philips Expression MR400 - Specifications; General

ExpressionMR400InstructionsforUse SpecificationsA‐1
APPENDIX A
Specifications
General
Patient Safety
ConformstoANSI/AAMIES60601‐1.CertifiedtoCAN/CSAC22.2No.60601‐1‐08;IEC60601‐1‐2
Conformsto93/42/EECasamendedby2007/47/EEC,Medica lDeviceDirective
Defibrillatorprotectionupto5KVDC
Accordingtothedegreeofingressprotection:RatedIP21
(Protectedagainstaccesstohazardouspartsandtheingressof
solidforeignobjectsgreaterthan12.5mm(0.5inch),
andagainstverticallydripp i ngliquid.)
Whereappropriate, theequipmentcomplieswithworldwidestandardsforsafetyandperformanceofeachsystem
feature,whenconsideringthe indicationsforusewithintheMRenvironment.Thisequipmentcomplieswiththe
followinginternationalindustrystandardsforsafetyand
performance:
•ISO14971,Medicaldevices‐Applicationofriskmanagementtomedicaldevices
•IEC60601‐1,MedicalElectrical EquipmentPart1:GeneralRequirementsforSafety(Amendment1)IEC60601‐
1,clause16,MedicalElectrical(ME)Systems
•ETSIEN300‐440‐1,ElectromagneticcompatibilityandRadiospectrumMatters(ERM);Shortrangedevices;
Radio
equipmenttobeusedinthe1GHzto40GHzfrequencyrange
•ETSIEN300‐440‐2,ElectromagneticcompatibilityandRadiospectrumMatters(ERM);Shortrangedevices;
Radioequipmenttobeusedinthe1GHzto40GHzfrequencyrange
•ETSIEN301‐489‐1,ElectromagneticcompatibilityandRadiospectrum
Matters(ERM);Electromagnetic 
Compatibility(EMC)standardforradioequipmentandservices;Part1:Commontechnicalrequirements‐V1.5.1
•ETSIEN301‐489‐3,ElectromagneticCompatibilityandRadioSpectrumMatters(ERM);Electromagnetic
Compatibility(EMC)StandardforRadioEquipmentandServices;Part3:SpecificConditionsforShort‐Range
Devices(SRD)OperatingonFrequenciesbetween
9KHzand40GHz‐V1.4.1
•EN980:Symbolsforusein labelingofmedicaldevices
•EN1041:Informationsuppliedbythemanufacturerofmedicaldevices
•BSEN12470‐4:20 01+A1:2009,ClinicalThermometers–Part4:PerformanceofElectricalThermometersfor
ContinuousMeasurement
•IEC60068‐2‐1,EnvironmentalTesting–Part2‐
1:Test–TestA:Cold
•IEC60068‐2‐2,EnvironmentalTesting–Part2‐2:Test–TestB:DryHeat
•IEC60068‐2‐6,EnvironmentalTesting–Part2:Tests–TestFE:Vibration(Sinusoidal)
•IEC60068‐2‐27,EnvironmentalTesting–Part2:Tests–TestEBandGuidance:Bump
•IEC60068‐2‐64,EnvironmentalTesting–Part
2:TestMethodsTestFH:VibrationBroad‐bandRandom(Digital
Control)andGuidance
•IEC60601‐1‐2,MedicalElectricalEquipmentPart1‐2:GeneralRequirementsforSafety‐CollateralStandard:
ElectromagneticCompatibility‐RequirementsandTests