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29
For each claimed range, the oxygen saturation accuracy of the Pulse
Oximeter should be represented in the form of mean root square of
the difference between the measured values of oxygen saturation
and the reference value. The formula is as follows:
Arms=
n
SSPO
n
i
Ri
1
2
i2 )(
Arms: accuracy
n
: test sample quantity
iSPO2
: measured value of pulse oxygen saturation during the first
measurement using the finger pulse Oximeter
iRS
: reference value of pulse oxygen saturation during the i
th
measurement using the carbon-monoxide-blood-gas analyzer
5. Characteristics of Population under Clinical Research
The summary clinical research report for evaluating SpO
2
accuracy
should state whether the tested subject suffers from disease or is
healthy, and should state the skin color, age, and gender of the tested
subject.
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