MECG 2.0

ECG Performance Tester

Suitable for R&D and Compliance Testing

The MECG 2.0 is an ECG database player designed for system validation and software algorithm evaluation.

Compliant with IEC 60601-2-25, IEC 60601-2-47, ANSI/AAMI EC57, YY0782, and YY0885 standards.

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Manual Spec Sheet

Overview

Load and replay multi channel ECG waveforms for diagnostic and ambulatory ECG
Output analog signals simultaneously – up to 8 channels and support 12 leads ECG
Embedded CAL, ANE, NST, and biological waveforms
Directly supports AHA, MIT, CU, NST, ESC, and PhysioNet format databases
Digital file playback – repeatedly play clinical-recorded or programmed waveforms
High resolution output voltage – 0.15μV (MECG 2.0 (2020))
Command replay – program test sequences with commands
Software Development Kit (SDK) – develop customized or automated test software with ease

Short Specs

Item	Details	Value
Output Channels	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	– MECG 2.0, ±1% for values greater or equal to 500μV and ±5μV for values under 500μV – MECG 2.0 (2020), ±1% for values greater or equal to 100μV. ±5μV for values under 100μV
Output voltage resolution	MECG 2.0 uses 12 bit DAC and MECG 2.0 (2020) uses 16 bit DAC	MECG 2.0 for 2.4μV and MECG 2.0 (2020) for 0.15μV
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 a 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 laboratory environment. The selection of critical components such as reference voltages, DAC, and precision resistors are known to be stable in the range shown	15-30°C 10-95% RH

Ordering Info

MECG 2.0 Test System

Model No.	Description
MECG 2.0	Multi channel 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.

Optional Software Add-on Pack

Model No.	Description
EDF-MECG	EDF file format playback function with PhysioNet Non-Invasive Fetal ECG Database download capability. Recommend to use with MECG 2.0.

Optional Accessory

Model No.	Description
WUI100	USB isolator for reducing the power noise from PC. Recommended to use with SECG 4.0, MECG 2.0, HRS200, HRS100+ and SEEG 100.

Optional Calibration Service and Warranty Extension

Model No.	Description
C3	Provides 3 years of calibration service coverage. WhaleTeq equipment can be calibrated to original performance on the basis of 1 year interval.
R3	Extend the product warranty from 1 year to 3 years.

What’s In The Box

Software