low-noise ECG analog signals testing

SECG 5.0 AIO

Designed specifically for hardware and system engineers, this standalone multi-vital sign simulator outputs highly accurate and low-noise ECG analog signals. It can superimpose various signals, including respiration, lead-off, and noise simulation signals, aiding engineers in performing tests that closely resemble real-world scenarios to effectively verify the performance of the device under test (DUT). When paired with WhaleTeq’s PPG modules, it can simultaneously simulate SpO2 signals for PWTT or PWV testing.

Equipped with the standard assistant software, it enables engineers to conduct compliance tests conforming to the following standards within a few clicks: IEC 60601-2-25, IEC 60601-2-27, IEC 60601-2-47, GB 9706.225, GB 9706.227, YY 9706.247, YY1079, YY1139, YY0782, YY0885, JJG 760, JJG 1042, ANSI/AAMI EC11, and ANSI/AAMI EC13.

OVERVIEW

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.

SPECIFICATION

ECG Test Mode

Parameters Specifications

Main Output Voltage Accuracy ±1% for amplitudes of 0.5mVpp or higher

Main Output Voltage Resolution

(DAC resolution) 0.63μV

Frequency / Pulse Repetition Rate Accuracy ±0.5%

Pulse Duration / Timing Accuracy (excluding pacing) ±0.5ms

ECG Duration Accuracy ±0.5ms

Pacing Pulse Width Accuracy ±5μs

Pacing Pulse Amplitude Accuracy, Range ±2mV pulse: ±0.3%

>2mV pulse: ±10%

Range: ±2mV ~ ±700mV

Pacing Pulse Characteristics Rise/fall time 5μs

Overshoot<1%

Settling time<1%

Pacing Pulse Overshoot (intentional) Method A according to IEC 60601-2-27

Resistor Tolerance ±1%

Capacitor Tolerance ±5%

Precision 250:1 Divider ±0.1%

Sample Rate 10kHz ± 0.05%

DC Offset

(fixed, noise-free, sourced from the internal supercapacitor) 300mV ± 1%

DC Offset

(variable, up to 1000mV, may include up to 50μVpp noise) ±1000mV ±1% or ±3mV

Environment 5 ~ 40°C

50 ~ 80% RH

altitude<2000M

Overvoltage CAT II