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OB1203 Certification Preparation, Setup, and Test Procedure

 

 

X0119984   Rev.1.0 
Mar 11, 2021 

 

Page 2  

 

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.  

This document describes the following required steps for a successful completion: 

1.  Collecting the required equipment 

2.  Preparation of measurement  

3.  Test setup calibration 

4.  Test data collection 

5.  R-curve generation based on data collected 

6.  Validation test using the test setup 

7.  Creation of measurement threshold 

2.  Required Equipment 

■

 

WhaleTeq AECG100 with 940nm test head 

●

 

WhaleTeq AECG100 GUI installed 

■

 

OB1203SD-RL-EVK Heart Rate, SpO2, and Respiration Rate Evaluation kit (reference board). 

●

 

With installed calibration software 

●

 

Renesas E2 or E2 Lite programmer including programming software 

●

 

Renesas E2 or E2 Lite to OB1203SD-RL-EVK programming adapter board 

■

 

Renesas opto-mechanical test adapter with inserted Aluminum reflector cone 

■

 

The device under test – DUT 

3.  Preparation of Test Equipment 

3.1 

WhaleTeq AECG100 Hardware and Software Setup 

Follow the 

WhaleTeq documentation

 to complete the setup and proceed to the next step. 

 

Figure 1. SP02 Test Setup with WhaleTeq AECG100 

Содержание OB1203

Страница 1: ...se 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 Tes...

Страница 2: ... curve generation based on data collected 6 Validation test using the test setup 7 Creation of measurement threshold 2 Required Equipment WhaleTeq AECG100 with 940nm test head WhaleTeq AECG100 GUI installed OB1203SD RL EVK Heart Rate SpO2 and Respiration Rate Evaluation kit reference board With installed calibration software Renesas E2 or E2 Lite programmer including programming software Renesas E...

Страница 3: ...Test Adapter In order to optically and mechanically couple the OB1203SD RL EVK reference board and the DUT to the WhaleTeq test head it is required to provide a stable reliable and repeatable adapter This adapter ensures that the test procedure can be followed successfully and to achieve repeatable test results that support the requirements of this procedure Renesas has created a universal test ad...

Страница 4: ...il into one cavity of the adapter making sure the applicator fits snuggly into the cavity use firm but light pressure 3 Remove the applicator and the Aluminum foil from the cavity 4 Use a sharp knife and cut off the excess of the Aluminum foil just above the cone there should be a small cutting groove to assist a straight cut see Figure 8 image on top left 5 Apply a thin layer of glue to the outsi...

Страница 5: ...f the DUT 2 Renesas Test Adapter The DUT must be aligned optically so that the light is un obstructed in both directions Pay special attention to the alignment of the optical divider inside the cone because it must be in the correct orientation separating the light between LEDs and Photo detectors with minimal crosstalk 3 The Renesas test adapter should have at least one side of the cone covered w...

Страница 6: ...ode 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 Parameter in Header File OB1203 h SpO2 HR Algorithm Test Software Comment Light level ADC THRESH_COUNT 196 k 32 k Required threshold of light coming from the Whale...

Страница 7: ...t SpO2 display 70 to 100 45 to 110 Range limit in Display In order to re flash the DUT 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...

Страница 8: ... and Test Procedure X0119984 Rev 1 0 Mar 11 2021 Page 8 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 Vcc Pin 8 Reset Pin 10 and 13 connect both Tool0 Pin 5 ...

Страница 9: ... the connector is listed on the evaluation board The pins are Vcc 3 3 VDC Tool0 Reset Ground d Flash the mot file on the RL78 5 Test Setup Calibration using the Reference Board Run the calibration software on the OB1203SD RL EVK Reference board It scrolls through four screens that illustrate calibration values necessary for this process SpO2 HR LED current ADC counts for IR and Red Software versio...

Страница 10: ...haleTeq AECG100 Setup 1 Set the AECG100 SpO2 settings to the following parameters in the GUI Figure 12 WhaleTeq AECG100 GUI Screenshot for Initial Test Fixture Setup In the Sp02 Tab In the RED Parameter block Check Lock DC box Red AC of 18 70 mV Red DC of 2000 mV In the IR Parameter block Check Lock DC box IR AC of 15 00 mV IR DC of 1000 mV For this test all other settings can be left to default 2...

Страница 11: ...ure 3 Proceed to next step 6 DUT Determination and Correction of Sp02 Errors Induced by External Optical Crosstalk 6 1 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 Because this cr...

Страница 12: ...over window on the DUT by applying the black tape directly onto the OB1203 Black tape applied directly to OB1203 Note ADC counts per mA red Note ADC counts per mA IR Black tape applied to cover window Note ADC counts per mA red 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...

Страница 13: ...ance The following graph shows that the cover window induces significant inaccuracy while the cross coupling correction factor corrected the measurement 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 co...

Страница 14: ...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 ...

Страница 15: ...does not display an incorrect value therefore the threshold must be determined and added to the software Note that the perfusion index can be increased by warming your finger 6 Repeat this test for lines 2 and 3 of the table 7 2 Determination of the Minimum Signal Strength Threshold To calculate the threshold values for IR and Red do the following 1 Red AC Threshold ADC count Red DC ADC count from...

Страница 16: ...s will establish the correction values 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 R2 default calibration curve b Set the AECG100 SpO2 settings to o Red DC of 2000mV o IR DC of 1000mV o Click both Lock DC boxes o Red AC of 15mV o IR AC of 18 7mV c C...

Страница 17: ...xcel spreadsheet s validation step to validate that the DUT is now measuring correctly 7 5 Test Report Generation With the values from the validation step the Report tap generates a test report 8 Human Calibration Test This test is performed in an outside test lab For calibration typically five subjects are tested Based on passing the previous test we expect to get data from all five subjects The ...

Страница 18: ...OB1203 Certification Preparation Setup and Test Procedure X0119984 Rev 1 0 Mar 11 2021 Page 18 9 Revision History Revision Date Description 1 0 Mar 11 2021 Initial release ...

Страница 19: ...re intended for developers skilled in the art designing with Renesas products You are solely responsible for 1 selecting the appropriate products for your application 2 designing validating and testing your application and 3 ensuring your application meets applicable standards and any other safety security or other requirements These resources are subject to change without notice Renesas grants yo...

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