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OB1203 Certification Preparation, Setup, and Test Procedure
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
X0119984 Rev.1.0
Mar 11, 2021
Manual
Page 1
© 2021 Renesas Electronics
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Summary of Contents for Renesas OB1203
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Page 1: Table Of Contents
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. -
Page 2: Test Purpose
OB1203 Certification Preparation, Setup, and Test Procedure 1. Test Purpose Customers who desire to obtain regulatory certification for their product equipped with Renesas’ OB1203 will need to perform human subject testing. Since these tests are time consuming and complex, it is best to prepare by performing pre-setup and pre-tests dry runs. -
Page 3: Opto-Mechanical Test Fixture
Renesas has created a universal test adapter that can be machined or 3D printed. For more details, please see below. - Page 4 It has been determined that aluminum foil is a good material for this purpose, and Renesas has provided an applicator to insert the foil properly. This applicator can also be 3D printed.
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Page 5: Mounting The Reference Board And Opto-Mechanical Test Adapter
The fixture is machined or printed as required to fit the case of the DUT, aligning the cross bar in the fixture with the center of the OB1203, and not blocking the LEDs or detector. The fit must exclude external light. The DUT must be mechanically aligned and securely mounted to the fixture. -
Page 6: Reference Board Setup And Preparation
“test mode”, push the wake button again until “Run mode change” appears on the display. The test software supports printing test values on the display for easy post-processing. This OB1203 test software is identical to the Renesas provided version running on the DUT except for the following:... - Page 7 1. Download the Renesas Flash Programmer. 2. Create a new project as described in the Renesas Flash Programmer Manual (please see the manual on the Flash Programmer webpage) which is downloaded with the Flash Programmer software. 3. In the Programmer setup, use as controller the RL78 group, R5F100BG as device, and the .mot file as the programming file.
- Page 8 OB1203 Certification Preparation, Setup, and Test Procedure b. Set up as described in the manual. Table 1. Required Pins Function Pinout at Programming Tool Ground Pin 2, 12 and 14 (connect all) Pin 8 Reset Pin 10 and 13 (connect both)
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Page 9: Test Setup Calibration Using The Reference Board
OB1203 Certification Preparation, Setup, and Test Procedure c. Connect the Flash programmer to the adapter board and the adapter board to the four pin E1 connector on the RL78 evaluation board. The pinout of the connector is listed on the evaluation board. The pins are: ○... -
Page 10: Initial Setup Of The Aecg100 Tester
OB1203 Certification Preparation, Setup, and Test Procedure Initial Setup of the AECG100 Tester 5.1.1. Calibration of Opto-mechanical Test Fixture This test calibrates the optical parameters of the test fixture and ensures that the DUT receives sufficient signal to continue with this test. To assure a consistent reference, this step is performed with the OB1203SD-RL-EVK reference board as described in the previous steps. -
Page 11: Dut Determination And Correction Of Sp02 Errors Induced By External Optical Crosstalk
External Optical Crosstalk Background The OB1203 is designed to be used either in direct contact with skin or with a secondary cover window. If the final DUT implementation uses an additional cover window, it may provide a path for additional optical crosstalk between the LEDs and the detector. - Page 12 Note ADC counts per mA IR Next, enter the ADC and mA values of the DUT with cover glass in the header file OB1203.h, as cross_ir_adc, cross_ir_mA, cross_r_adc, cross_r_mA. In the following example, the IR current was 170mA and the IR ADC count 600.
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Page 13: Crosstalk Correction Validation
Figure 13. Before and After Correction The results in the graph show that while cross-coupling through a cover window can have a large effect on accuracy, the OB1203 software can successfully correct for any particular cover window inducing cross- coupling. -
Page 14: Dut - Dark Skin Sensitivity And Low Perfusion Limit Determination
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. -
Page 15: Determination Of The Minimum Signal Strength Threshold
OB1203 Certification Preparation, Setup, and Test Procedure Table 3. Adjust IR AC Counts to Find 90% Sp02 Limits for Various Skin Types Pass/Fail GUI Red GUI IR SP02 86.5% to Red DC [mV] IR DC [mV] IR AC [mV] GUI IR PI... -
Page 16: Sp02 Saturation Value Test Before Calibration
(R-curve) for the DUT on the simulated test. It does not check the actual accuracy on human test subjects. Set the AECG100: a. Set the default calibration curve of the OB1203. SpO2 = 107.36 - 10.29 * R - 28.15 * R (default calibration curve) b. -
Page 17: Sp02 Saturation Validation
OB1203 Certification Preparation, Setup, and Test Procedure d. Adjust the R-curve: Set the SpO2 value to each of the values in the Excel spreadsheet (see the following figure and Recalculation of R-curve XLS located on the OB1203SD-RL-EVK webpage). This will automatically adjust the Red AC to simulate the set value in the GUI. -
Page 18: Revision History
OB1203 Certification Preparation, Setup, and Test Procedure 9. Revision History Revision Date Description Mar 11, 2021 Initial release. X0119984 Rev.1.0 Page 18 Mar 11, 2021... - Page 19 Renesas' products are provided only subject to Renesas' Terms and Conditions of Sale or other applicable terms agreed to in writing. No use of any Renesas resources expands or otherwise alters any applicable warranties or warranty disclaimers for these products.
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