Fukuda Denshi DSL-8001, Operation Manual

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Other Information
Functional Testers and Patient Simulator for SpO
2
measurement
Some models of commercially available bench top functional testers and patient
simulators can be used to verify the proper functionality of pulse oximeter
sensors, cables and pulse oximeters. See the operator’s manual of the individual
testing device for the procedure which is specific to the model of tester being
used.
While such devices may be useful for verifying that the pulse oximeter sensor,
cabling, and pulse oximeter are functional, they are incapable of providing the
data required to properly evaluate the accuracy of a system's SpO
2
measurements.
Fully evaluating the accuracy of the SpO
2
measurements requires, at a minimum,
accommodating the wavelength characteristics of the sensor and reproducing the
complex optical interaction of the sensor and the patient’s tissue. These
capabilities are beyond the scope of known bench top testers.
SpO
2
measurement accuracy can only be evaluated in vivo by comparing pulse
oximeter readings with values traceable to SaO
2
measurements obtained from
simultaneously sampled arterial blood using a laboratory Co-oximeter.
Many functional testers and patient simulators have been designed to interface
with the pulse oximeter's expected calibration curves and may be suitable for use
with pulse oximeters and/or sensors. Not all such devices, however, are adapted
for use with the calibration system. While this will not affect use of the simulator
for verifying system functionality, displayed SpO
2
measurement values may differ
from the setting of the test device.
For a properly functioning pulse oximeter, this difference will be reproducible over
time and from pulse oximeter to pulse oximeter within the performance
specifications of the test device.