Renesas OB1203, Manual

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Manual
OB1203 Certification Preparation, Setup, and Test Procedure
X0119984 Rev.1.0
Mar 11, 2021 Page 1
© 2021 Renesas Electronics
Overview
SpO2 measurements are affected by two variations in the human body. The first is skin color. The second is the
blood perfusion, which causes optical modulation and varies based on the person’s temperature and health.
Changes in these variants affect SpO2 measurements.
In this pre-calibration test procedure, both of these variables are simulated and the oximeter output is monitored.
Renesas provides test stimuli simulating various conditions that represent the majority of the human population.
Therefore, a successful execution in the actual human subject testing certification testing can be assumed.
Contents
1. Test Purpose .................................................................................................................................................. 2
2. Required Equipment ...................................................................................................................................... 2
3. Preparation of Test Equipment .................................................................................................................... 2
3.1 WhaleTeq AECG100 Hardware and Software Setup ............................................................................ 2
3.2 Opto-mechanical Test Fixture ............................................................................................................... 3
3.2.1. Preparing the Opto-mechanical Test Adapter ......................................................................... 3
3.2.2. Mounting the Reference Board and Opto-mechanical Test Adapter ...................................... 5
4. Reference Board Setup and Preparation .................................................................................................... 6
5. Test Setup Calibration using the Reference Board ................................................................................... 9
5.1 Initial Setup of the AECG100 Tester ................................................................................................... 10
5.1.1. Calibration of Opto-mechanical Test Fixture ......................................................................... 10
6. DUT Determination and Correction of Sp02 Errors Induced by External Optical Crosstalk ............... 11
6.1 Background .......................................................................................................................................... 11
6.2 Methods ............................................................................................................................................... 11
6.3 Crosstalk Correction Validation ........................................................................................................... 13
7. DUT – Dark Skin Sensitivity and Low Perfusion Limit Determination ................................................... 14
7.1 Dark Skin Sensitivity Test .................................................................................................................... 14
7.2 Determination of the Minimum Signal Strength Threshold .................................................................. 15
7.3 SP02 Saturation Value Test before Calibration ................................................................................... 16
7.4 Sp02 Saturation Validation .................................................................................................................. 17
7.5 Test Report Generation ....................................................................................................................... 17
8. Human Calibration Test .............................................................................................................................. 17
9. Revision History .......................................................................................................................................... 18