A310B Pulse Oximeter
8
*DSP algorithm
: Digital signal processor algorithm.
CAUTION
: The device cannot be used to measure the child
below 1 years as the test result is not guarantee to accurate.
CAUTION
: The fingertip pulse oximeter is intended only as an
adjunct in patient assessment. It must be used in conjunction
with other methods of assessing clinical signs and symptoms
CAUTION
: A function tester cannot be used to assess the
accuracy of a pulse oximeter monitor or sensor.
Clinical testing is used to establish the SpO2 accuracy. The
measured arterial hemoglobin saturation value (SpO2) of the
sensor is compared to arterial hemoglobin oxygen(SaO2) value,
determined from blood samples with a laboratory CO-oximeter.
The accuracy of the sensors in comparison to the CO-oximeter
samples measured over the SpO2 range of 70 -100%. Accuracy
data is calculated using the root-mean-square(Arms value) for
all subjects. Only about two-thirds of PULSE OXIMETER
EQUIPMENT measurements can be expected to fall within
±Arms of the value measured by a CO-Oximeter.
Pulse simulator shall be used to assess Pulse rate
Accuracy. The measured pulse rate is compared to the preset
pulse rate value in simulator. Accuracy data is calculated using
the root-mean-square (Arms value) for all subjects.
