Renesas OB1203 User manual

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
7.2Determination 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

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

OB1203 Certification Preparation, Setup, and Test Procedure
X0119984 Rev.1.0
Mar 11, 2021
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Figure 2. WhaleTeq AECG100 Tester with PPG Module Attached
Figure 3. Mechanical Drawing of Fixture Base PPG-2R
3.2 Opto-mechanical Test Fixture
3.2.1. Preparing the Opto-mechanical 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 adapter that can be machined or 3D
printed. For more details, please see below.

OB1203 Certification Preparation, Setup, and Test Procedure
X0119984 Rev.1.0
Mar 11, 2021
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Figure 4. Top View of the OB1203
to WhaleTeq Test Adapter
Figure 5. Side View of OB1203 to
WhaleTeq Test Adapter
Figure 6. Perspective View of
OB1203 to WhaleTeq Test Adapter
The 3D stl file can be printed on a 3D printer (see OB1203SD-RL-EVK webpage for file).
It is also required to apply (at least on one side of the test adapter) a reflective insert ensuring acceptable optical
performance, and at the same time, eliminating uncertainty from the print quality and/or material properties. 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.
Procedure to Insert the Aluminum Foil Using the Applicator
1. Use an appropriately sized piece of Aluminum foil and wrap it around the
pointed end of the applicator in a single ply.
2. Insert the Aluminum foil 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 outside of the Aluminum foil and re-insert the
Aluminum foil using the applicator tool.
6. This time, remove the applicator leaving the Aluminum foil behind in the cavity.
It should be held in place by the glue.
7. Using a small tool, clear the optical opening at the tip of the adapter of the
Aluminum foil and 3D print material ensuring an un-obstructed path for the optical
signal.
Note: The cavity with the Aluminum foil should be used on the Photo Detector
receiver side of the DUT and the LED side of the WhaleTeq test head to collect
the maximum light possible and funnel it into the DUT receiver.
DUT OB1203
DUT OB1203
DUT OB1203
Renesas Test
adapter
WhaleTeq
Test head
Figure 7. Illustration of
Applicator Inserted into Test
Adapter
Figure 8. Illustration of
Cutting Groove

OB1203 Certification Preparation, Setup, and Test Procedure
X0119984 Rev.1.0
Mar 11, 2021
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3.2.2. 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.
3.2.2.1. Opto-Mechanical Test Head Stack Up
1. Top: OB1203 Device Under Test.
The DUT must be mechanically attached and stable so that it cannot move.
Figure 9. Test Stack Up with Aluminum Foil Insert on the Receive Side of 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 with a reflective material such
as a layer of Aluminum foil. Please use the provided applicator and follow the instructions on inserting the
reflective layer into the cone. The reflective side of the cone should be on the sensor side of the DUT.
4. WhaleTeq Test Head.
The test head also has an optical divider eliminating crosstalk between the LED and photo detector. Please
ensure that the all dividers are aligned properly.
Figure 10. WhaleTeq Test Head with Optical Divider

OB1203 Certification Preparation, Setup, and Test Procedure
X0119984 Rev.1.0
Mar 11, 2021
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4. Reference Board Setup and Preparation
To simplify this step, it is recommended to use an OB1203SD-RL-EVK board from Renesas. Please contact
Renesas support to request.
Each OB1203SD-RL-EVK is equipped with test mode software. In order to switch between “normal mode” and
“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:
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 WhaleTeq to
start algorithm
PS_THRESHOLD_HI to
start algorithm
15 k
200
Required threshold of light
coming from the WhaleTeq to
start algorithm
BIO_THRESHOLD
8 k
2 k
Display
SpO2 / HR
SpO2 / HR
ADC counts for IR and Red

OB1203 Certification Preparation, Setup, and Test Procedure
X0119984 Rev.1.0
Mar 11, 2021
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LED current
Software version
MAX_LOW_SAMPLES
30
500
to allow routine to continue while changing GUI
parameters for 10 s
Keeps the algorithm awake
preventing battery conserving
time out
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 file as the
programming file.
a. Buy a Flash Programmer like the Renesas E2 lite.

OB1203 Certification Preparation, Setup, and Test Procedure
X0119984 Rev.1.0
Mar 11, 2021
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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

OB1203 Certification Preparation, Setup, and Test Procedure
X0119984 Rev.1.0
Mar 11, 2021
Page 9
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:
○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 version
Figure 11. Calibration Software Screens

OB1203 Certification Preparation, Setup, and Test Procedure
X0119984 Rev.1.0
Mar 11, 2021
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5.1 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.
5.1.1.1. WhaleTeq 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. Push “Play” and observe the IR and Red ADC counts on the calibration reference devices’ OLED display
running the OB1203 calibration software.
Adjust the IR DC and Red DC values in the WhaleTeq GUI so that the DUT Display reads 60.000 (counts)
for IR and 40.000 (counts) for Red.