User's Manual

989803173791 Rev 0.6AppendixA:Specifications79
AlarmLimits
SpO
2
AlarmLimits Low:50to99orOff
High:70to99orOff
HeartRateAlarmLimits Low:30to249orOff
High:60to249orOff
Note:
Meas uremen t validation:
SpO
2
accuracyhasbeenvalidatedinhumans tudie sagains tart erialbloodsamplereferenc e
meas uredwithaCO‐oximeter.Inacontrolledde saturat ionstudy ,he alth yadultvolunt eerswithsaturationle vels
between 70%and100%SaO
2
werestudie d.Thepopulationcharacteris ticsforthosestudieswere:
• about50%femaleand50%malesubjects
• agerange:19‐27
•skintone:fromlighttoblack
Afunctionaltestercannotbeusedtoassesstheaccuracyofapulseoximetermonitor;however,itcanbeusedto
demonstratethataparticularpulse
oximetermonitorreproducesacalibrationcurvethathasbeenindependently
demonstratedtofulfillaparticularaccuracyspecification.
SpO
2
measurementsarestatisticallydistributed;therefore,inaccordancetoISO9919:2005,itispossiblethatonly
two‐thirdsofthemeasurementswillfallwithin±3percentofthevaluemeasuredbytheCO‐Oximeter
PowerAdapter
PowerRequirements
InputVoltage(toACinlet) UniversalAC;100to240VAC@50to60Hz.
InputPower 0.4amps,without powerfactorcorrection.
DCConnector 15VDC
Environment
Location Consoleroom(OutsidetheMRsystemroom)
OperatingTemperature 10°Cto40°C(50°Fto104°F)
StorageTemperature ‐25°to70°C(‐13°Fto158°F)
RelativeHumidity 15%to90%,non‐condensing