When "HR" is derived from SPO2
Lower
Upper
Note
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.
Side stream, non‐dispersive infrared absorption technique, includes multiple filtration system and microprocessor
logic control of sample handling and calibration. Method for determining end‐tidal CO2 measurement: Measures
peak of the end‐tidal CO2 waveform every 20 seconds.
Output
Initialization Time
Zero Calibration Interval
CO2 Unit of Measure
CO2 Resolution
Flow Rate
Data Sample Rate
End‐tidal CO2 (EtCO2) Measurement Range
(In which the CO2 accuracy specification is met)
A‐10 Specifications
Pulse Oximeter
Off, or 30 to 250 BPM
60 to 250 BPM, or off
CO2 (Optional LoFlo)
CO2 waveform, EtCO2
and respiration rate
Waveform displayed in less than 20 seconds, at an ambient
temperature of 25°C (77°F); full specifications attained within 2
minutes
Automatic or user requested
Millimeters of mercury (mmHg) or kilopascals* (kPa)
1 mmHg (0.1 kPa)
50 mL/minute ± 10 mL/minute
100 Hz
0 to 76 mmHg (0 to 10.1 kPa) for respiration rates ranging from 4
to 60 breaths per minute, inclusive
and FiCO2
measurement numeric values,
Expression MR400 Instructions for Use
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