17-8
FM5000C - FM5000PLUS
Maternal/Fetal Monitor
User Manual
NOTE: This feature is only available onMasimo SpO
2
.
17.7 SPO2 Accuracy Test
The recommended method of determining the SpO2 accuracy of the monitor is to compare its SpO2
readings with the readings of a CO-oximeter.
Warning
A functional tester or SpO2 simulator cannot be used to access the accuracy of a pulse
oximeter probe or a pulse oximeter monitor.
Note
Confirmation about SpO2 measurement accuracy: accuracy of SpO2has been confirmed in
the comparison between experiment on human being and referential value of arterial blood
measured by CO-oxygen pressure gauge. Measurement results of Pulse Oxygen Meter are
subject to statistical distributions, which are, compared to measurement results by
CO-oxygen pressure gauge, expected to fall in designated accuracy range with 2/3 results.
Masimo SpO2 has passed the non-motion accuracy verification by compared to the
laboratory joint photoelectric oximeterand monitor in the human blood research where
healthy adult volunteers
’
SpO2 value are at 70% to 100% under the inducible hypoxic
condition.This difference equals to
±
one standard deviation, which contains 68% of the
sample.
Masimo SpO2 has passed the motion accuracy verification in the human blood
research where healthy adult volunteers conduct friction motion or tapping motion at 2 to 4
Hz to induce a hypoxic condition. There is no repeated movement at range from 1 to 2 cm and
frequency from 1 to 5 Hz. When set at inducible hypoxic condition (SpO2 70% ~100%) with
range from 2 to 3 cm, the results should compare those of laboratory joint photoelectric
oximeterand monitor. This difference equals to
±
one standard deviation, which contains
68% of the sample.
17.8 Low Perfusion Accuracy Test
This monitor can measure low perfusion and the recommended method of determining the low perfusion
accuracy of the monitor is to compare its low perfusion readings with the readings of a simulator.
