User's Manual

989803173791 Rev 0.6AppendixA:Specifications77
Appendix A: Specifications
General
PatientSafety
ConformstoULSTD60601‐1.CertifiedtoCAN/CSASTDC22.2No.601.1
Accordingtodegreeofprotectionagainstharmfulingressofwater:IPX2(equipmentisprotectedfromvertically
drippingliquid)
Thisequipmentcompliestothefollowinginternationalindustrystandardsforsafetyandperformance:
•IEC60601‐1,GeneralRequirementsforSafety
ofMedicalElectrical Equipment
•IEC60601‐1‐2,GeneralRequirementsforSafety‐ElectromagneticCompatibility
•IEC60601‐1‐4,GeneralRequirementsforSafetyofProgrammableElectricalMedicalSystems
•IEC60601‐1‐8,GeneralRequirements,TestsandGuidanceforAlarmSystemsinMedicalElectrical
EquipmentandMedicalElectricalSystems
•ISO9919,ParticularRequirementsfor
theBasicSafetyandEssentialPerformanceofPulseOximeter
EquipmentforMedicaluse
Whereappropriate,theequipmentcompliestoworldwidestandardsforsafetyandperformanceofeachsystem
feature,whenconsideringthe indicationsforusewithintheMRenvironment.
PowerRequirements
OperatingVoltage Batteryonly
Battery
Type Lithiumpolymer
OperationTime Monitor:Approximateoperationtimeis8hours.
Module:Approximateoperationtimeis8hours.
ChargeTime Monitor:Timerequiredtorechargeafullydischargedbatteryis
approximately8hours.
Module:Timerequiredtorechargeafullydischargedbatteryis
approximately6hours.
Environment
OperatingTemperature 10°Cto40°C(50°Fto104°F)
StorageTemperature Batteries:0°Cto40°C(32°Fto104°F)
System:‐25°Cto70°C(‐13to158°F)
Whenstoringbeyondthetemperaturerangesspecified,remove
thedesignatedcomponentandstoreitappropriately.
RelativeHumidity 15to90%,non‐condensing
TransportTemperature ‐25°Cto70°C(‐13
to158°F)