Origins

In the development of medical devices, ECGs are highly complex with numerous test items. Moreover, international medical standards (IEC 60601-2-XX) categorize tests into diagnostic ECGs, patient monitors, and ambulatory ECGs, thus requiring engineers to be familiar with various test parameter settings to ensure reliable validation.

To reduce engineers’ effort, we have integrated the necessary parameters for development and compliance tests into a single device, creating the multifunctional ECG simulator for performance testing－SECG 5.0 AIO. It offers basic parameter settings required for ECGs and simulates various signals in real monitoring scenarios, such as electrical noise, respiratory signals, and NST noise, allowing for comprehensive testing of ECG monitoring devices' interpretation capabilities and noise tolerance.

The SECG 5.0 AIO is designed for standalone operation, enabling engineers to set test parameters by simply tapping its touchscreen and preventing potential noise from computer connections. In addition, with a built-in isolator, the SECG 5.0 AIO can reduce electrical noise interference.

Considering the need for additional vital signs verification in the development of patient monitors or wearable devices, the SECG 5.0 AIO can be paired with different PPG modules to simulate SpO₂ signals and synchronize them with ECG signals for PWTT (Pulse Wave Transit Time) testing.
Additionally, with the respiration module, the parameter settings of impedance respiratory signals can be optimized to simulate a wider range of testing scenarios.

As the most comprehensive ECG simulator on the market, featuring our exclusive Standard Assistant Software and a free software development kit (SDK), we envision the SECG 5.0 AIO becoming the best aid for engineers－a single device for completing multiple vital signs tests to eliminate inconvenience during verification.

Functions

 Outputs 7 Types of Standard ECG Waveforms

Outputs ECG, Sine, Triangle, Square, Exponential, Rectangle Pulse, and Triangle Pulse waveforms, while also simulating DC offset signals, pacing signals, and electrical noise to superimpose for testing.

Adjustable ECG Waveforms

Allows flexible adjustment of values for P amplitude and duration, QRS amplitude and duration, PR and QT intervals, ST deviation, and T amplitude according to testing needs.

Respiratory Signal Simulation

Provides impedance respiratory signals as well as baseline, amplitude, and frequency-modulated respiratory signals, which can be freely adjusted and superimposed on ECG signals. With the optional respiration module, the parameter settings of impedance respiratory signals can be optimized for more comprehensive testing.

NST Noise Simulation

Allows the superimposition of simulated electrode motion artifact, baseline wander, and muscle noise on standard test signals or raw data playback, with an adjustable gain range from 0.1 to 10.

Lead-off Simulation

Simulates four scenarios—lead-on, 10MΩ, 20MΩ, and lead-off—to test ECG monitoring devices’ lead-off detection capabilities.

Automated Pacing, Heart Rate, and Frequency Scan Tests

Organizes various test parameters, including different values for amplitude, duration, etc., enabling automated testing of all combinations with a single click.

Raw Data Playback

Supports playback of ECG databases, and reproduces clinically recorded or user-defined waveforms to rapidly verify signal processing systems and algorithms.

Simple Automated Testing

Uses the "Auto Sequence" function to organize and store frequently used test items for automated testing.

Standard Assistant Software

Integrates international medical standard testing requirements, allowing users to click on tabular test items, wait for the DUT to display test results, and then enter the results to complete compliance tests. Paired with our TRF Generator software, it can automatically generate a comprehensive test report.

  SpO₂ and PWTT Function Testing

Paired with the PPG modules to simulate PPG signals to test SpO₂ function with adjustable AC, DC, and PI values of red light and infrared light.
Synchronizes ECG and PPG signals for PWTT testing to verify the accuracy of non-invasive blood pressure measurement algorithms.

Highlights

 Integrates Essential Parameters and Advanced Simulation Functions for ECG Performance Testing with Intuitive Touchscreen Operations

• Adjustable ECG and 6 standard waveforms in a wide range and precise values for flexible test settings
• Allows the superimposition of DC offset signals, pacing signals, and electrical noise on ECG signal output, and provides respiratory signals, NST noise, and lead-off simulation signals for more authentic testing

Raw Data Playback on Any Lead — Performance Verification Using Real ECG Signals

• Supports playback of ECG databases or clinically recorded waveforms to test the DUT's interpretation capability
• Plays user-defined signals to verify specially designed specifications

 

 Provided SDK for Flexibly Developing Programs as Needed

• Users can develop automated testing software based on their needs to control the testing process, reducing the effort of repetitive setups

 

Standard Assistant Software for Effortlessly Conducting Compliance Tests

• Supports ECG-related international standards IEC 60601-2-25, IEC 60601-2-27, and IEC 60601-2-47, as well as the latest Chinese regulations GB 9706.225, GB 9706.227, and YY 9706.247
• Tabular design allows users to click on cells to output preset test signals without manual settings

Note: The Standard Assistant Software needs a separate purchase.

Optional PPG Modules for Expanded SpO₂ and PWTT Testing Capabilities

• With PPG-2TF-660 (transmittance SpO₂ module) or PPG-2R-880/PPG-2R-940 (reflectance SpO₂ module), users can adjust AC, DC, PI values of red light and infrared light to simulate PPG signals for testing SpO₂ accuracy, and create or load R curves for rapid performance verification
• With PPG-1R-525 (reflectance green light heart rate module), users can use green light analog signals to simulate PPG signals

•  All three PPG modules can synchronize ECG and PPG signals for PWTT testing, verifying the accuracy of non-invasive blood pressure measurement algorithms; additionally, built-in add-on signals such as respiration simulation and 14 types of ambient light signals* are available for more authentic testing

  *Note: Only the PPG-2TF-660 supports ambient light signal simulation.

Optional Respiration Module for Optimized Measurement Range and Resolution of Impedance Respiratory Signals

• Expands respiratory measurement range of SECG 5.0 AIO from the original 500Ω–2500Ω to a range of 100Ω–4500Ω

• Optimizes variability resolution of SECG 5.0 AIO from the original 1.0Ω–5.0Ω to a range of 0.0Ω–10.0Ω with a minimum step size of 0.05Ω within the range of 0.0Ω–5Ω

• Raw data playback — loads and plays clinically recorded or user-defined waveforms to rapidly verify respiratory signal processing systems and algorithms

  Note: The respiration module only supports ECG mode.