Philips Expression MR400 - Page 371

ExpressionMR400InstructionsforUse SpecificationsA‐3
• 2002/96/EC,DirectiveonWasteofElectricalandElectronicEquipment
• 2006/66/EC, BatteryDirective
•ANSI/AAMIBP22,BloodPressureTransducers
•ANSI/AAMIEC13,CardiacMonitors,HeartRateMeters,andAlarms
•ANSI/AAMIEC53,ECGtrunkcablesandpatientleadwires
•ASTME‐1112—2000,StandardSpecificationforElectronicThermometerfor
IntermittentDeterminationof
PatientTemperature
•ASTMF2052‐14,StandardTestMethodforMeasurementofMagneticallyInducedDisplacementForceon
MedicalDeviceinMREnvironment
•ASTMF2503‐13,StandardPracticeforMarkingMedicalDevicesandotherItemsforSafetyintheMR
Environment
•FCCPart15.249(47CFRPart15.249),RadioFrequencyDevices
–Operationwithinthebands902‐928MHz,
2400‐2483MHz,5725‐5875MHz,and24.0‐24.25GHz
•UL2054,StandardforHouseholdandCommercialBatteries
•IEC62133,Secondarycellsandbatteriescontainingalkalineorothernon‐acidelectrolytes,Standardfor
HouseholdandCommercialBatteries
•RSS‐210,Issue7,Low‐powerLicense‐
exemptRadioCommunicationDevices(AllFrequencyBands):Category1
Equipment
•SAAAS/NZS3200.1.2,MedicalElectricalEquipmentPart1‐2:GeneralRequirementsforSafety‐Collateral
Standard:ElectromagneticCompatibility‐RequirementsandTests
•ISO14155‐1,Clinical investigationofmedicaldevicesforhumansubjects.Part1:Generalrequirements
•IEC62304,MedicalDeviceSoftware:Softwarelife
cycleprocesses
•JIST0601‐2‐34,MedicalElectricalEquipment–Part2‐34:ParticularRequirementsfortheSafety,Including
EssentialPerformance,ofInvasiveBloodPressureMonitoringEquipment
•JIST1306,ContinuousMeasuringClinicalElectricalThermometers
•ISO80601‐2 ‐56,Medicalelectricalequipment.Part2‐56:Particularrequirementsforbasicsafetyand
essential
performanceofclinicalthermometersforbodytemperaturemeasurement
Power Requirements, Cart
OperatingVoltageRange 100to240VAC,±10percent
FrequencyRange 50to60Hz,singlephase
Current 1.4A@100VAC/0.7A@240VAC
PowerConsumption,Maximum 65Watts
Protection Internallyfused(3.15A,slowblow@250VAC),AClineand
neutral
General