OverviewThe SECG 4.0 ECG simulator is designed specifically for compliance testing of ECG products, producing accurate low-noise analog ECG signals and providing DC offset and input-impedance test capabilities required by medical device standards. It is suitable for rapid verification in QA labs and on production lines, supports playback of clinically recorded or user-defined waveforms, and includes an SDK for automated test integration. The Standard Assistant Software offers preset test values for one-click compliance testing across multiple international and national standards (software sold separately).
Functions- Outputs multiple waveform families: ECG, sine, triangle, square, exponential, rectangular pulse and triangular pulse, with adjustable amplitude, frequency, pulse width, QRS duration and T-wave amplitude.
- DC offset signal simulation with fixed ±300 mV capability and flexible variable offset adjustment.
- Input-impedance testing using the standard 620 kΩ / 4.7 nF configuration.
- Pacing-signal simulation with adjustable amplitude and duration; single- or dual-pulse modes to superimpose pacing on ECG signals.
- Electrical noise injection (50 Hz and 60 Hz) to overlay mains interference on ECG signals.
- Automated pacing and heart-rate test sequences: organizes parameter combinations to enable automated execution of many test cases.
- Raw-data playback: supports playback of ECG databases and clinically recorded waveforms to verify device signal processing and interpretation.
- Standard Assistant Software: integrates international testing requirements and provides presets for required test signals.
Highlights- Raw-data playback on any lead to validate device interpretation using real ECG records.
- User-defined waveform playback to verify custom specifications.
- Provided SDK for development of automated test programs and integration into production or QA workflows.
- Standard Assistant Software supports IEC 60601-2-25, IEC 60601-2-27, IEC 60601-2-47 and multiple regional standards; preset values enable rapid compliance testing (software sold separately).
Technical specifications- Main output voltage accuracy: ±1% for amplitudes ≥ 0.5 mVpp.
- Main output voltage resolution (DAC): 2.5 µV.
- Frequency / pulse repetition rate accuracy: ±0.2%.
- Pulse duration / timing accuracy (excluding pacing): ±0.2 ms.
- Pacing pulse width accuracy: ±1 µs.
- Pacing pulse amplitude accuracy and range: for ±2 mV pulse: ±0.3%; for >2 mV pulse: ±10%; range ±2 mV to ±700 mV.
- Resistor tolerance: ±0.5%.
- Capacitor tolerance: ±5%.
- Precision 1000:1 divider (100 kΩ:100 Ω): ±0.1%.
- Sample rate: 5 kHz ± 0.05% (50 ppm).
- DC offset (fixed, noise-free from internal supercapacitor): 300 mV ±0.1%.
- DC offset (variable, may include up to 50 µVpp noise): setting accuracy ±1% or ±3 mV.
- Signal types and ranges (selected): Sine/Triangle/Square frequency 0.05–500 Hz; amplitude −10–10 mV; BPM 3–30000 BPM (default 60 BPM). Rectangle and Triangle pulses frequency 0.05–5 Hz, pulse width 2–300 ms. Exponential frequency 0.05–3 Hz. ECG-2-27 waveform QRS amplitude −5.7–5.7 mV; QRS duration 5–200 ms; T amplitude 0–5 mV; frequency 0.05–6 Hz.
- Special waveform: load user-defined waveforms from a computer (user-defined waveform playback supported).
- Signal add-ons: DC offset adjustable −1000–1000 mV; pacing amplitude −700–700 mV; pacing duration 0.1–2 ms; pacing rate 10–300 BPM or synchronization; overshoot time constant 0–100 ms; pulse types: single, double (150 ms), double (250 ms).
- Supported output lead electrodes: RA (R), LA (L), LL (F), V1–V6.
- Noise: main noise options 50 Hz, 60 Hz (80 Hz and 100 Hz available for capacitance correction); noise amplitude 0.01–2 mV p-p.
- Frequency scan (sine): start 0.67–500 Hz, stop 0.67–500 Hz, duration 10–180 s.
- Package contents (standard SECG 4.0 Test System): SECG 4.0 x1, 12-lead breakout box x1, compound terminal x12, USB cable x1, grounding wire x1.