A‐10Specifications ExpressionMR400InstructionsforUse
When“HR”isderivedfromSPO2
Lower
Upper
Off,or30to250BPM
60to250BPM,oroff
Measurement validation: SPO2 accuracy validated in human studies against arterial blood sample reference measured with
a CO-oximeter. In a controlled desaturation study, healthy adult volunteers with saturation levels between 70–100 percent
SPO2 were studied. The population characteristics for those studies were:
• about 50% female and 50% male subjects
• 19 – 27 years of age
• light to black skin tones
Reference method for the computation of pulse rate accuracy made using an electronic pulse simulator. (A functional
tester cannot be used for accuracy assessment of a pulse oximeter monitor; however, it can demonstrate that a pulse
oximeter monitor reproduces a calibration curve that has been independently demonstrated to fulfill a particular
accuracy specification.)
SPO2 measurements are statistically distributed; therefore, in accordance to 80601-2-61:2011, it is possible that only
two-thirds of the measurements will fall within ± 3 percent of the value measured by the CO-Oximeter.
CO2 (Optional LoFlo)
Sidestream,non‐dispersiveinfraredabsorptiontechnique,includesmultiplefiltrationsystemandmicroprocessor
logiccontrolofsamplehandlingandcalibration.Methodfordeterminingend‐tidalCO2measurement:Measures
peakoftheend‐tidalCO2waveformevery20seconds.
Output CO2waveform,EtCO2
andFiCO2
measurementnumericvalues,
andrespirationrate
InitializationTime Waveformdisplayedinlessthan20seconds,atanambient
temperatureof25°C(77°F);fullspecificationsattainedwithin2
minutes
ZeroCalibrationInterval Automaticoruserrequested
CO2UnitofMeasure Millimetersofmercury(mmHg)orkilopascals*(kPa)
CO2Resolution 1mmHg(0.1kPa)
FlowRate 50mL/minute±10
mL/minute
DataSampleRate 100Hz
End‐tidalCO2(EtCO2)MeasurementRange
(InwhichtheCO2accuracyspecificationismet)
0to76mmHg(0to10.1kPa)forrespiration ratesrangingfrom4
to60breathsperminute,inclusive
Pulse Oximeter