OB1203 Certification Preparation, Setup, and Test Procedure
X0119984 Rev.1.0
Mar 11, 2021
Page 14
7. DUT – Dark Skin Sensitivity and Low Perfusion Limit
Determination
7.1
Dark Skin Sensitivity Test
This procedure tests the performance of the DUT at the “corner” of dark skin sensitivity and low perfusion. It
represents the worst-case condition in a human subject test case ensuring that the DUT is likely to perform to
the required certification standard levels.
Complete the following instructions:
1. Run the test mode on the DUT.
2. Set up the DUT on the WhaleTeq AECG100 test fixture using the adapter used in the reference calibration
step before. It is likely that you have to make some opto-mechanical adjustments – this is acceptable and
within reasonable limits.
3. Set the following AECG100 settings in the GUI.
a. Set the default calibration curve of the DUT’s OB1203 algorithm. These are the values wanted to
evaluate and adjust using this procedure.
SpO2 = 107.36 - 10.29 * R - 28.15 * R2
b. Set the AC and DC settings per line 1 of Table 3. Check the “lock DC” boxes for both red and IR.
c. Click the radio button for PI(R).
d. Set the SpO2 value to 90%. This will automatically adjust the Red AC to simulate 90%.
