ECG tester  for production lines, designed for production lines can simultaneously test ECG function on up to 4 wearable devices with a single computer to accelerate testing time.

This tester provides IEC 60601-2-47 test items and outputs 7 types of standard ECG waveforms to assist DUTs in conforming with regulatory requirements.

For customized testing, the raw data playback function can reproduce clinical data or user-defined waveforms to help users verify that the DUTs meet the manufacturer's specifications. This tester integrates needed equipment to optimize testing efficiency while ensuring product quality and a stable production process. It’s suitable for manufacturers who have mass-production needs on wearable devices with the ECG function.

Compliance tests conforming with IEC 60601-2-47, China YY0885, and YY 9706.247-2021

SPECIFICATION

Standard ECG waveforms

ParametersRangeResolutions

ECG WaveformFrequency (Hz)0.02 ~ 6Hz0.01

Frequency (BPM)1 ~ 360BPM1

Amplitude(-5) ~ 5mV0.01

SineFrequency (Hz)0.05 ~ 500Hz0.01

Frequency (BPM)3 ~ 30000BPM1

Amplitude(-10) ~ 10mV0.01

TriangleFrequency (Hz)0.05 ~ 500Hz0.01

Frequency (BPM)3 ~ 30000BPM1

Amplitude(-10) ~ 10mV0.01

SquareFrequency (Hz)0.05 ~ 500Hz0.01

Frequency (BPM)3 ~ 30000BPM1

Amplitude(-10) ~ 10mV0.01

ExponentialFrequency (Hz)0.05 ~ 5Hz0.01

Frequency (BPM)3 ~ 300BPM1

Amplitude(-5) ~ 5mV0.01

Rectangle PulseFrequency (Hz)0.05 ~ 5Hz0.01

Frequency (BPM)3 ~ 300BPM1

Amplitude(-5) ~ 5mV0.01

Pulse width (frequency: 0.05Hz)1 ~ 300ms1

Pulse width (frequency: 5Hz)1 ~ 200ms1

Triangle PulseFrequency (Hz)0.05 ~ 5Hz0.01

Frequency (BPM)3 ~ 300BPM1

Amplitude(-5) ~ 5mV0.01

Pulse width (frequency: 0.05Hz)1 ~ 300ms1

Pulse width (frequency: 5Hz)1 ~ 200ms1

Input Impedance / Frequency Response Signal add-on

ParametersRangeDefault ValuesResolutions

Play raw dataSample rateMaximum: 40K Hz--

DC offset (non-Variable)-300, 0, +300mV0mV300

DC offset (Variable)(-1000) ~ 1000mV0mV100

Input impedance switch100Ω (short circuit)--

620kΩ / 4.7 nF on/offOff (on: short circuit)-

10MΩ / 180 pF on/offOff (on: short circuit)-

Product System Capacity and Standard Requirements Table

ParametersSpecificationsSystem Capability

Main output voltage accuracy±1% for amplitudes of 0.5mVpp or higher±0.3%

Main output voltage resolution

(DAC resolution)N/A0.15µV

Frequency / pulse repetition rate accuracy±1%±0.1%

Pulse duration / timing accuracy±1ms±0.2ms

Resistor tolerance±1%±0.5%

Capacitor tolerance±5%±5%

Precision 1000 : 1 divider±0.5%±0.3%

Sample rate5kHz ± 0.1%10kHz ± 0.05% (50ppm)

DC offset

(fixed, noise-free, sourced from the internal supercapacitor)300mV ± 1%300mV ± 0.1%

DC offset

(variable, up to 1000mV)Setting ±1% or ±3mVSetting ±1% or ±3mV

Environment15 ~ 30°C (by design)

30 ~ 80% RH (by design)5 ~ 40°C

30 ~ 80% RH

altitude < 2000M

Overvoltage CAT II

ECG tester  for production lines