SECG 4.0

The SECG 4.0 ECG simulator is designed specifically for compliance testing of ECG products, providing highly accurate and low-noise ECG analog signals. It offers DC offset signals and input impedance testing required by medical standards, making it ideal for quick verification in the QA department and production line.
With the Standard Assistant Software, users can simply click on test items to perform compliance testing in accordance with the following international medical standards: IEC 60601-2-25, IEC 60601-2-27, IEC 60601-2-47, ANSI / AAMI EC11, ANSI / AAMI EC13, GB9706.225, GB9706.227, YY9706.247, YY1079, YY1139, YY0782, YY0885, JJG 760, JJG 1041, and JJG 1042.

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Origins

Developing ECG devices requires manufacturers to invest significant resources, not only to ensure superior performance but also to meet regulatory requirements, which is essential.
According to international medical standards (IEC 60601-2-XX), compliance testing for ECG devices is divided into various categories, such as diagnostic ECGs, patient monitors, and Holter monitors, each requiring different tests. Manufacturers must be well-versed in setting parameters for these tests to confidently verify their products.

To assist manufacturers in saving time on studying medical standards and simplify compliance testing, we designed the SECG 4.0 ECG simulator with resistor and capacitor circuits conforming to standards. By connecting it to a computer and launching the dedicated software, users can control the SECG 4.0 to generate basic ECG, DC offset, and pacing signals required by standards.

With our Standard Assistant Software, users can easily select preset values to automatically output test signals that meet regulatory requirements, significantly reducing the time spent on studying standards and manually setting test parameters.
Furthermore, we offer a raw data playback feature to accommodate manufacturers who need to test with customized waveforms, and a free software development kit (SDK) is available for users to develop testing programs based on their needs.

Compliance testing is an essential part of ECG device development, and we believe the SECG 4.0 will effectively ease the burden on manufacturers, allowing them to focus more on optimizing their products.

Note: To download the Linux SDK, please visit the Download page.

Functions

Select

Outputs 7 Types of Standard ECG Waveform
DC Offset Signal Simulation
Input Impedance Testing
Pacing Signal Simulation
Electrical Noise Simulation
Automated Pacing and Heart Rate Testing
Raw Data Playback
Standard Assistant Software

Outputs ECG, Sine, Triangle, Square, Exponential, Rectangle Pulse, and Triangle Pulse waveforms with adjustable amplitude, frequency, pulse width, QRS duration, and T wave.

Provides standard values as ±300mV for superimposing on the ECG signal. Flexible adjustment of the value is available according to testing needs.

Provides a standard 620kΩ / 4.7nF configuration for testing the quality of signal reception.

Allows adjustment of parameters such as amplitude and duration for pacing signals, with options for single or dual pulses to be superimposed on ECG signals.

Simulates 50Hz and 60Hz electrical noise for superimposing on ECG signals.

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

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

Integrates international medical standard testing requirements. Users can simply click on preset values to output signals, making compliance testing effortless. Paired with our TRF Generator software, a comprehensive test report can be automatically generated.

Highlights

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
Provides values required by standard test items, allowing users to output test signals with a single click and eliminating the need for manual setup

Note: The Standard Assistant Software needs a separate purchase.

Parameters	Specifications	System capability
Main output voltage accuracy	±1% for amplitudes of 0.5mVpp or higher	±0.3%
Main output voltage resolution (DAC resolution)	N/A	2.5µV
Frequency / pulse repetition rate accuracy	±1%	±0.1%
Pulse duration / timing accuracy (excluding pacing)	±1ms	±0.2ms
Pacing pulse width accuracy	±5µs	±1µs
Pacing pulse amplitude accuracy, range	±2mV pulse: ±1% >2mV pulse: ±10% Range: ±2mV ~ ±700mV	±2mV pulse: ±0.3% 100mV pulse: ±1% or ±5mV
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%	±0.5%
Capacitor tolerance	±5%	±5%
Precision 1000:1 divider (100kΩ:100Ω)	±0.2%	±0.1%
Sample rate	5kHz ± 0.1%	5kHz ± 0.05% (50ppm)
DC offset (fixed, noise free, from internal supercapacitor)	300mV ± 1%	300mV ±0.1%
DC offset (variable, may include up to 50µVpp noise)	Setting ±1% or ±3mV	Setting ±1% or ±3mV

Product Introduction

Case Study

Operation Guide

Customer Testimonial

SECG 4.0 Test System

Part No.	Description	Quantity
100-EC00102	Model No.: SECG 4.0 Single channel ECG test system for 12 leads (RA, LA, LL, N, V1 - V6), including one ECG breakout box (BB-C1) and 12 compound terminals	1

Optional Software Add-on Pack

Part No.	Description
HA0-SE0F001	Auto setup for IEC 60601-2-25:2011 performance tests
HA0-SE0F002	Auto setup for IEC 60601-2-27:2011 performance tests
HA0-SE0F003	Auto setup for IEC 60601-2-47:2012 performance tests
HA0-SE0F004	Auto setup for China YY1079-2008 performance tests
HA0-SE0F005	Auto setup for China YY1139-2013 performance tests
HA0-SE0F006	Auto setup for China YY0782-2010 performance tests
HA0-SE0F007	Auto setup for China YY0885-2013 performance tests
HA0-SE0F008	Auto setup for China JJG760-2003 performance tests
HA0-SE0F010	Auto setup for China JJG1042-2008 performance tests
HA0-SE0F011	Auto setup for China JJG1041-2008 performance tests
HA0-SE0F012	Auto setup for China GB 9706.225-2021 performance tests
HA0-SE0F013	Auto setup for China GB 9706.227-2021 performance tests
HA0-SE0F014	Auto setup for China YY 9706.247-2021 performance tests

Optional Accessory

Part No.	Description	Quantity
100-OT00001	USB isolator for reducing the power noise from PC. Recommended to use with SECG 4.0, MECG 2.0, HRS200, HRS100+, SEEG 100 and SEEG 100E.	1

Optional Calibration Service and Warranty Extension

Part No.	Description
YY0007	Model No.: C3 Provides (3) years of calibration service coverage. WhaleTeq equipment can be calibrated to original performance on the basis of (1) year interval.
YY0008	Model No.: R3 Extends the limited warranty from (1) year to (3) years.