AECG100
AECG100

AECG100

The Innovative simulator to output ECG and PPG analog signals simultaneously. Adjustable time difference parameters to generate various Pulse Wave Transit Time (PWTT) signals. Complies with the latest international medical standards: IEC 60601-2-47, IEC 63203-402-3:2024, YY 0885, YY 9706.247, suitable for R&D, production lines and compliance testing.
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Overview

Origins

Health wearable devices make it easier for us to measure various vital signs, such as heart rate, blood oxygen, blood pressure, etc., and manufacturers are committed to developing accurate and reliable products. However, signals of both ECG and PPG are extremely small, and the environment is often full of various noises. In addition, optical sensors, hardware design, etc. will affect the accuracy of the signals. It is not easy to include such a complex and delicate design on a wearable device. 

We deeply understand the difficulties faced by manufacturers. Therefore, we integrate functions such as ECG, reflectance or transmittance PPG, and PWTT into the AECG100 multi-functional performance tester. The AECG100 main unit itself can simulate ECG electrical signals, and can be extended with different PPG modules to emit simulated single green light heart rate or simulated dual-light red light and infrared light SpO2 blood oxygen saturation signals, and provide a variety of simulation signals on the AECG100 software. AECG100 not only has a wider range of parameter selection, but also has detailed scale selection. 
 
When we use wearable devices to test blood oxygen saturation, we also need to pay special attention to test with low PI values (Perfusion Index). FDA in " Review of Pulse Oximeters and Factors that can Impact their Accuracy" recommends that a PI value test of less than 1 be performed to provide accurate test results when the blood perfusion index is low. AECG100 is also equipped with this function and can set the PI value flexibly.

We also found that with the diversified development of today's wearable devices, including watches, rings, etc. of different styles, the difficulty of testing has increased. So, we provide customers with 100% customized optical modules and fixtures, which not only perfectly fit the receiving positions of the LEDs and PDs of the objects under test, achieving more accurate test results, but their test items also comply with the latest standard IEC 63203-402 in 2024 - 3:2024; and our ECG test items comply with IEC 60601-2-47.

At the same time, in order to allow engineers to conduct testing more efficiently, we also provide a free Software Development Kit (SDK), which helps to develop automated testing software, flexibly expand testing capabilities, and reduce human errors that may result from repeated settings and operations. Now, we can use the AECG100 to accurately test health wearable devices, ensuring product accuracy and reliability, and compliance with medical standards.
 

 

Functions

 

REPAIR

Basic Waveform Output

Includes ECG Waveform, Sine, Triangle, Square, Exponential, Rectangle and Triangle Pulse, adjustable parameters, and DC offset signal testing.

Performance

ECG Signal Generation

Simulates ECG signals, pacing signals, respiratory signals, noise superposition, frequency response, and input impedance testing.

REPAIR

PPG Signal Generation

Simulates Sine, Triangle, and PPG signals, provides simulated signals of green, red and infrared light, measuring reflectance PPG heart rate and SpO2 blood oxygen saturation signals.

Performance

Adjustable Pulse Wave Transit Time

Simultaneously sends out ECG and PPG signals, adjusts the time difference (PTTp, PTTf) between the two signals, verifies the accuracy of the blood pressure algorithm.

 

Efficiency

Blood Oxygen R Curve Simulation 

Simulates the R curve of DUT to verify the SpO2 and perfusion index (PI) values.
 

Performance

Saving Test Parameters

Saves test parameters of different test items for integrated testing to reduce human errors.

REPAIR

Raw Data Playback

Replays raw data and reproduces clinically recorded or customized waveforms.

Performance

Standard Assistant Software

Provides easy-to-operate Standard Assistant Software to help complete compliance testing.

REPAIR

Automated Test

Supports automated testing, using software to control the entire testing process, and manually edit auto-sequence for testing.

 

Highlights

Wide Range of Adjustable Parameters and Fine Scale of Details

 
title

 

       Note: The PWTT function can only be used with the PPG-2TF-660 / PPG-2R-880 

                 SpO2 module.

Compliance Verification and Clinical Data Reproduction

 
title
  • Complies with the latest wearable device standard IEC 63203-402-3:2024 and supports PPG green light heart rate testing
  • Playback raw data to achieve high reproducibility and repeatability
  • Optional Standard Assistant Software to simplify IEC 60601-2-47 / YY-0885 / YY9706.247 compliance testing

 

 

Multifunctional PPG Module with Testing Flexibility

title
  • Software Development Kit (SDK) flexibly expands testing capabilities
  • Provide reflectance or transmittance, single-optical or dual-optical modules to meet different testing needs
  • Standalone mode can store 3 sets of parameter combinations for quick testing

Specification

ECG Mode

ParametersSpecifications
Main Output Voltage Resolution2.5μV (DAC resolution)
Main Output Voltage Accuracy±1% for amplitudes of 0.5mVpp or higher
Frequency / Pulse Repetition Rate Accuracy±1%
Pulse Duration / Timing Accuracy±1ms
Pacing Pulse Amplitude Setting Range-1000mV ~ +1000mV
Pacing Pulse Amplitude Accuracy±2mV pulse: ±1%
>2mV or <-2mV pulse: ±10%
Pacing Pulse Width Setting Range0.1ms ~ 2ms
Pacing Pulse Width Minimum Step Size0.1ms
Pacing Pulse Width Accuracy±5μs
Pacing Pulse Characteristics Rise/Fall Time5μs
Pacing Pulse Characteristics Overshoot<1%
Pacing Pulse Characteristics Setting Time<1%
Sample Rate50 ~ 40kHz (Normal mode/Standalone mode); 40kHz (Raw data mode)
Sample Rate AccuracyDepend on system clock accuracy
DC Offset Range 
(fixed, noise free, sourced from internal supercapacitor)
-300mV, +300mV
DC Offset Accuracy
(fixed, noise free, sourced from internal supercapacitor)
±1%
DC Offset Setting Range 
(variable, may include up to 50μVpp noise)
-500mV ~ +500mV
DC Offset Accuracy 
(variable, may include up to 50μVpp noise)
±1%
RCA Output Amplitude RangeECG electrode output x1000, max 10V
RCA Output Amplitude Accuracy±1% for amplitudes of 0.5Vpp or higher
S/N Ratio>51DB (with USB isolator)

 

PPG Mode

ParametersSpecifications
Heart Rate Setting Range10 ~ 300BPM
Heart Rate Minimum Step Size1 BPM
Heart Rate Accuracy±1 BPM 
LED DC Level Reference Output Setting Range100 ~ 3000mV
LED DC Level Reference Output Minimum Step Size1mV
LED AC Level Reference Output Setting Range0.75 ~ 30mV
LED AC Level Reference Output Minimum Step Size0.01mV
Lumen Setting Range50 ~ 925 Lux (full range) (5mm from diffusion film)
Lumen Resolution(1 / 3000) full range
Lumen Accuracy±6%
Light Wavelength Range525 / 660 / 880 / 940nm
Light Wavelength Accuracy±10nm
LED Scan Rate50 ~ 40kHz (Normal mode/Standalone mode); 10kHz (Raw data mode)
LED Scan Rate Accuracy±5μs
PD Sample Rate250kHz (single channel)
PD Sample Rate Accuracy±5μs
PD Response Time (Rising)1μs Typical (Varies from DUT LED intensity)
PD Response Time (Falling)1μs Typical (Varies from DUT LED intensity)

 

PWTT Mode

ParametersSpecifications
Time Difference (PTTp, PTTf) Setting Range0 ~ 5999ms (for the heart rate setting as 10BPM. As the heart rate value increases, the setting range of time difference will decrease accordingly.)
Time Difference (PTTp, PTTf) Minimum Step Size1ms
Time Difference (PTTp, PTTf) Accuracy±1ms

 

SpO2 Mode

ParametersSpecifications
Heart Rate Setting Range10 ~ 300 BPM
Heart Rate Minimum Step Size1 BPM
Heart Rate Accuracy±1 BPM
LED DC Level Reference Output Setting Range100 ~ 3000mV
LED DC Level Reference Output Minimum Step Size    1mV 
LED AC Level Reference Output Setting Range 0.75 ~ 30mV 
LED AC Level Reference Output Minimum Step Size 0.01mV 
PI (AC level/DC level) Setting Range 0.025% ~ 30% (AC/DC, varies with AC or DC level) 
PI (AC level/DC level) Accuracy NA 
LED Light Wavelength Range Red: 660nm; Infrared: 940nm/880nm 
LED Light Wavelength Accuracy Red:±10nm; Infrared: ±10nm 
Red Light Absolute Irradiance(100%) Intensity§ 3.55 mW / m^2 
Red Light Absolute Irradiance(100%) Accuracy ±15% 
Infrared Light Absolute Irradiance(100%) Intensity§ 6.65 mW / m^2 
Infrared Light Absolute Irradiance(100%) Accuracy ±15% 
LED Scan Rate50 ~ 40kHz (Normal mode/Standalone mode); 10kHz (Raw data mode)
LED Scan Rate Accuracy±5μs
PD Sample Rate250kHz (single channel)
PD Sample Rate Accuracy±5μs
PD Rising Response Time1μs Typical* 
PD Falling Response Time 1μs Typical* 
SpO2 (%) Setting Range1% ~ 100% 
SpO2 (%) Minimum Step Size 1% 
SpO2 (%) Accuracy ±1%+specified accuracy of the DUT (using Masimo Radical-7 Pulse CO-Oximeter or "Covidien" Nellcor Portable SpO2 Patient Monitoring System) 

§Data Collection Method: To connect the spectrometer with a 2-inch integrating sphere, and fix the integrating sphere on the DUT to measure the absolute irradiance of the LED of the DUT.

*Note: PD response time varies with the light intensity of the DUT.

Ordering information

AECG100 Main Console Unit 

Part No.DescriptionQuantity
100-AE00001Model No.: AECG100
The main console unit for ECG testing.
Supports ECG and Auto Sequence test modes.
1

 

PPG Module

Part No.DescriptionQuantity
100-AE00002Model No.: PPG-1R-525 
Model Name: Reflectance Green Light Heart Rate Module
The reflectance PPG module of 525nm green LED. 
Supports PWTT / PPG / Auto Sequence test modes.
1
100-AE00004Model No.: PPG-2R-880
Model Name: Reflectance SpO2 Module
The reflectance PPG module of 880nm IR LED and 660nm Red LED. 
Supports PWTT / SpO2 / PPG / Auto Sequence test modes.
1
100-AE00005Model No.: PPG-2R-940 
Model Name: Reflectance SpO2 Module
The reflectance PPG module of 940nm IR LED and 660nm Red LED. 
Supports PWTT / SpO2 / PPG / Auto Sequence test modes.
1
100-AE00007Model No.: PPG-2TF-660
Model Name: Transmittance SpO2 module
The transmittance PPG module.
Supports PWTT / Auto Test SpO2 / SpO2 / PPG / Auto Sequence test modes.
(two MCX (RF) male to BNC cables included)
1

 

Optional Software Add-on Pack

Part No.Description
HA0-AE01001Auto setup for IEC 60601-2-47:2012 performance tests.
HA0-AE01002Auto setup for YY 0885-2013 performance tests.
HA0-AE01003Auto setup for YY 9706.247-2021 performance tests.
HC0-AE01001The WhaleTeq database includes 30 records of PPG waveforms recorded in clinical trials to use in PPG test mode and 10 records of PPG and ECG waveforms recorded in clinical trials to use in PWTT test mode. The 25 recorded disease waveforms include symptoms such as AF (Atrial Fibrillation), APC (Atrial Premature Complexes), VPC (Ventricular Premature Contraction) and first degree AV block.
HC0-AE01002Standard waveforms in ECG, PPG, SpO2 and PWTT test modes can be saved in raw data formats for further modification

 

Optional Calibration Service and Warranty Extension

Part No.Description
YY0007Model No.: C3
Provides (3) years of calibration service coverage. WhaleTeq equipment can be calibrated to original performance on the basis of (1) year interval.
YY0008Model No.: R3
Extends the limited warranty from (1) year to (3) years.

 

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