ASTS Enterprises A310 - Expected Service Life

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*DSP algorithm: Digital signal processor algorithm.
*Low Perfusion: In physiology, perfusion is the process of a body delivering blood to a capillary bed in its
biological tissue. Under the condition of low perfusion, the measurement of non-invasive saturation of
pulse-blood oxygen is low-accurate.
*Plethysmograph: is an instrument for measuring changes in volume within an organ or whole body (usually
resulting from fluctuations in the amount of blood or air it contains).
PI （Perfusion Index ）is the ratio of the pulsatile blood flow to the non-pulsatile static blood flow in a patient's
peripheral tissue, such as finger tip, toe, or ear lobe. Perfusion index is an indication of the pulse strength at the
sensor site.
2.5 Expected Service Life
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The expected service life of the ME equipment;
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The expected service life of parts or accessories shipped with the ME equipment;
– Where the shelf life is less than the expected service life, the shelf life of parts or
Accessories shipped with the ME equipment.
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 SpO2 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.