ECG Database Player Designed for System Validation and Software Algorithm Evaluation

MECG 2.0

The ECG database player designed for system validation and software algorithm evaluation. Suitable for R&D and compliance testing.

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

OVERVIEW

Load and replay multichannel ECG waveforms for diagnostic and ambulatory ECG

Output analog signals simultaneously up to 8 channels and support 12-lead ECG

Embedded CAL, ANE, NST and biological waveforms

Directly support AHA, MIT, CU, NST, ESC and PhysioNet format databases

Support digital file playback function for user to repeatedly play clinical-recorded or programmed waveforms

Extreme output voltage resolution － 0.15μV for MECG 2.0 (2020)

Command replay function enables to program test sequences with commands

Software Development Kit (SDK) allows to develop customized or automated test software with less efforts

SPECIFICATION

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