Gima RS01, Manual, Page: 174 / 373

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Note 1: the claims of SpO2 accuracy shall be supported by clinical study measurements taken
over the full range. By artificial inducing, get the stable oxygen level to the range of 70 % to
100 % SpO2, compare the SpO2 values collected by the secondary standard pulse oximeter
equipment and the tested equipment at the same time, to form paired data, which are used for the
accuracy analysis. (It is applicable for the probes equipped)
There are 12 healthy volunteers (male: 6. female: 6; age: 18~45; skin color: black: 2, light: 8,
white: 2) data in the clinical report.
Note 2: Because pulse oximeter equipment measurements are statistically distributed, only about
two-thirds of pulse oximeter equipment measurements can be expected to fall within ±Arms of
the value measured by a CO-OXIMETER.
Note 3:PR accuracy has been verified using signals from the patient simulator .The difference
between the measured PR and the set value of the patient simulator is used to calculate the RMS
to indicate the accuracy of the PR.
gas
The mode of
operation
continuous operation
Display color LCD