MECG 2.0

The ECG Database Player simultaneously outputs analog signals up to 8 channels, supporting the 12-lead ECG system and algorithm verification. It is ideal for system and software engineers engaged in R&D and compliance testing. The MECG 2.0 provides built-in test signals required by medical standards and can directly load and play various ECG databases.
Meets the requirements of international medical standards including IEC 60601-2-25, IEC 60601-2-47, ANSI / AAMI EC57, YY0782, and YY0885.

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Origins

According to international medical standards, testing ECG devices requires not only hardware performance verification but also the assessment of ECG interpretation capability using specific databases to evaluate system functionality and the precision of algorithms. When using databases for testing, the simultaneous output of signals across all channels is essential—any time difference in a single channel can cause algorithms to misinterpret the data, leading to inaccurate results.
Achieving zero-latency output requires close integration between the hardware and software of a tester, presenting a hidden challenge for manufacturers developing ECG devices. This often demands extra resources to design suitable test equipment.

To address this challenge, we developed the MECG 2.0 ECG Database Player. Its optimized hardware design seamlessly cooperates with software, so whether playing large QRS amplitudes or subtle ST-segment deviations, the MECG 2.0 maintains high precision.
It supports playback of the Non-Invasive Fetal ECG Database from PhysioNet. To precisely reproduce fetal ECG, we have increased the MECG 2.0's resolution to 0.15μV, enabling customers to review their product's interpretation results according to subtle waveform changes.

In addition to its built-in waveforms from medical-standard-required databases, the MECG 2.0 is equipped with WhaleTeq's unique "Raw Data Playback" function. We've received positive feedback about this function from customers who are thrilled that their collected clinical data can now be played back using the MECG 2.0. For medical image recognition applications, we also anticipate this function aiding in AI training for ECG waveform recognition.

Another popular feature among our customers is the free software development kit (SDK). After each modification to an ECG algorithm, engineers can play thousands of data for automated testing using the SDK. They can start the test before getting off work and receive the results the next day, saving time and reducing the risk of altering test configurations.
We believe that the MECG 2.0 is not only a tool for compliance testing but also a valuable resource for enhancing ECG interpretation algorithms, helping manufacturers deliver the highest-quality ECG devices.

Functions

Select

Simultaneously Outputs Analog Signals to 8 Channels
Built-in CTS and CSE Databases
Loads ECG Databases
Fast PhysioNet Database Download
Raw Data Playback
Command Replay Function

Converts ECG signals into the analog format for playback, supporting system and algorithm testing of 12-lead ECG machines.

Provides CAL, ANE, NST, and biological waveforms required by medical standards for users to test within a few clicks.

Supports reading EDF, AHA, and CSE files.

Directly downloads and plays databases like MIT, CU, NST, and ESC without format conversion.

Reproduces clinically recorded or user-defined waveforms to rapidly verify signal processing systems and algorithms.

Automatically generates test command scripts during testing. Users can edit the testing sequence and save it as a "Command file" for future tests.

Highlights

Sophisticated Hardware and Software Design for Simultaneously Outputting Stable and Precise Signals to 8 Channels

Captures ECG signals with a sampling rate of 1kHz
Superior signal output resolution — MECG 2.0 (2020) provides a resolution of up to 0.15μV

Raw Data Playback — Performance Verification Using Real ECG Signals

Supports playback of 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 for numerous tests

Comprehensive Compliance Testing Solution

Saves time studying the medical standard and training by completing performance and database testing required by IEC standards with WhaleTeq ECG testing products

👉IEC 60601-2-25 Testing Package
👉IEC 60601-2-47 Testing Package

Items	Details / Reference	Values
Output channels	The 8 output channels are provided through a network as specified in IEC 60601-2-51 to provide signals to 10 lead electrodes; in the device under test, this will be displayed as 12 leads.	8 outputs 10 lead electrodes 12 leads
Voltage accuracy	IEC 60601-2-51 specifies a limit of ±1%, but does not provide a lower limit (all systems must have a lower limit). An inferred specification of 1% ±5µV is derived from the device under test specification in IEC 60601-2-51 of 5% ±25µV.	For MECG 2.0, ±1% for values greater or equal to 500μV and ±5μV for values under 500μV. For MECG 2.0 (2020), ±1% for values greater or equal to 100μV and ±5μV for values under 100μV.
Output voltage resolution	MECG 2.0 uses 12 bit DAC and MECG 2.0 (2020) uses 16 bit DAC.	2.4μV for MECG 2.0 and 0.15μV for MECG 2.0 (2020)
Output voltage	The output voltage on most of the database and ECG is +5mV－-5mV.	±5mV
Output noise level 0－150Hz	Output noise should not influence the test. A value as 5µV is suitable for this requirement. Can be verified by monitoring the signal in the device under test using a “diagnostic” filter setting.	<5µV
Time accuracy	IEC 60601-2-51 does not provide any limits. An inferred limit from the device under test. An inferred limit of ±1% is used. The system's design accuracy exceeds 0.1% as a 100ppm crystal reference is used.	±1%
Sampling rate	A maximum sampling rate of 1kHz matches the sampling rates of ECG files.	1kHz (8 channels)
Power supply	Powered from the USB supply (5V 0.2A)	N/A
Environment	Intended for normal laboratory environment. The selection of critical components such as reference voltages, DAC, precision resistors are known to be stable in the range shown.	15－30°C 10－95% RH

Product Introduction

Case Study

Operation Guide

MECG 2.0 Test System

Part No.	Description	Quantity
100-EC00101	Model No.: MECG 2.0 Multichannel ECG simulator equipped with 16 bit DAC for 12 leads (RA, LA, LL, N, V1–V6) output, including one ECG breakout box (BB-C1) and 12 compound terminals Package contents: ˙MECG 2.0 x 1 ˙Breakout box x 1 ˙Wire buckle x 12 ˙USB cable x 1 ˙Grounding wire x 1	1

Optional Software Add-on Pack

Part No.	Description
HC0-ME0D001	EDF file format playback function with PhysioNet Non-Invasive Fetal ECG Database download capability. Recommended to use with MECG 2.0.

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.