User's Manual

Table Of Contents
Chapter 8: Specifications 155
Specifications
EN60601237:2001+AmendmentA1:2005,
EuropeanNorm,Particularrequirements forthe
safetyofultrasonicmedicaldiagnosticand
monitoringequipment.
CAN/CSAC22.2,No.601.1M90,Canadian
StandardsAssociation,MedicalElectrical
Equipment–Part1.GeneralRequirementsfor
Safety(includingCSA601.1Supplement1:1994
andCSA601.1Amendment2:1998).
CEI/IEC61157:1992,International
ElectrotechnicalCommission,
Requirementsfor
theDeclarationoftheAcousticOutputof
MedicalDiagnosticUltrasonicEquipment.
UL606011(1st Edition),Underwriters
Laboratories,MedicalElectrical
EquipmentPart 1:GeneralRequirementsfor
Safety.
EMC standards classification
EN6060112:2007,European Norm,Medical
ElectricalEquipment.GeneralRequirementsfor
SafetyCollateralStandard.Electromagnetic
Compatibility.RequirementsandTests.
CISPR11:2004,InternationalElectrotechnical
Commission,InternationalSpecialCommitteeon
RadioInterference.Industrial,Scientific,and
Medical(ISM)RadioFrequencyEquipment
ElectromagneticDisturbance
CharacteristicsLimitsandMethodsof
Measurement.
TheClassificationfortheultrasoundsystem,
dockingsystem,accessories,andperipherals
whenconfiguredtogetheris:Group1,ClassA.
Airborne equipment
standards
RTCA/DO160E:2004,RadioTechnical
CommissionforAeronautics,Environmental
ConditionsandTestProceduresforAirborne
Equipment,Section 21.0EmissionofRadio
FrequencyEnergy,Category B.
DICOM standard
NEMAPS 3.15:2000,DigitalImagingand
CommunicationsinMedicine(DICOM)Part15:
SecurityProfiles.
HIPAA standard
TheHealthInsuranceandPortabilityand
AccountabilityAct,Pub.L.No.104191(1996).
45CFR160,GeneralAdministrative
Requirements.
45CFR164,SecurityandPrivacy.