OverviewThe AECG100 is a wearable-performance simulator that generates synchronized ECG and PPG analog signals for validation of wearable medical devices. It provides adjustable Pulse Wave Transit Time (PWTT) parameters, supports reflectance and transmittance PPG modules (green, red, infrared), and is intended for R&D, production-line and compliance testing. The system is designed to support IEC 60601-2-47, IEC 63203-402-3:2024, YY 0885 and YY 9706.247 workflows and includes GUI software, standalone operation and an SDK for automation.
Features- Basic waveform outputs: ECG, sine, triangle, square, exponential, rectangular and triangle pulses with adjustable amplitude, timing and DC offset.
- ECG generation: pacing simulation, respiratory modulation, configurable noise, frequency/impedance testing and standards-compliant ECG waveforms.
- PPG generation: analog PPG for reflective or transmissive sensors with configurable LED wavelengths (green, red, infrared) and adjustable AC/DC levels for HR and SpO2 testing.
- Adjustable PWTT: simultaneous ECG and PPG output with programmable time differences (PTTp, PTTf) to validate BP and timing-dependent algorithms.
- SpO2 and R-curve simulation: reproduce R-curve shapes and perfusion-index ranges for SpO2 algorithm verification.
- Test parameter management: save and recall parameter sets for repeatable testing and reduced operator variability.
- Raw data playback: reproduce recorded clinical or custom waveforms for repeatability and validation.
- Assistant software and SDK: GUI workflows, automation SDK and editable auto-sequences for production and compliance testing.
Highlights- High-resolution parameter control with DC offset capability; PI down to 0.025% (customizable).
- Standards support: IEC 63203-402-3:2024 (wearable PPG) and IEC 60601-2-47 (ECG).
- Raw clinical waveform playback for reproducibility.
- Standalone operation with storage for up to three parameter sets.
- Modular PPG options: reflectance or transmittance, single- or dual-optical modules to match DUT designs (smartwatch, ring, etc.).
- Custom fixtures and optical modules available to align DUT LEDs/PDs and improve measurement accuracy.
- SDK included for integration into automated test and production systems.
Technical specifications- General model: Model name: AECG100 (main console). Modes: ECG, PPG, PWTT, SpO2, respiration, Auto Sequence.
- ECG – Main output: DAC resolution 2.5 μV; amplitude accuracy ±1% (≥0.5 mVpp); frequency/pulse-rate accuracy ±1%; pulse timing accuracy ±1 ms; RCA output amplitude ×1000, max 10 V; S/N >51 dB (with USB isolator).
- ECG – Sample rate & DC offset: Sample rate 50—40 kHz (Normal/Standalone); 40 kHz (Raw data). DC offset fixed −300 mV to +300 mV (±1%); variable DC offset −500 mV to +500 mV (±1%).
- ECG – Waveforms & amplitudes: Waveforms: ECG, sine, triangle, square, exponential, rectangle pulse, triangle pulse. ECG amplitude (p–p) −5.71 to +5.71 mV. R wave −5 to +5 mV. T wave 0—5 mV. P wave 0—1 mV. ST deviation −1—1 mV.
- ECG – Timing: PR 100—200 ms (default 160 ms); QT 100—840 ms; QRS 10—200 ms; HR 10—300 BPM; timing step 1 ms; HR step 1 BPM.
- ECG – Pacing & noise: Pacing amplitude −1000 mV to +1000 mV; pacing width 0.1—2 ms (0.1 ms step); pacing rate 30—300 BPM. Noise generator 0—2 mV; selectable noise frequencies (50/60/100/120 Hz, etc.).
- ECG – Additional: Input impedance test 620 kΩ / 4.7 nF (selectable); RLD input test 1.5 V.
- PPG (Reflectance) – Heart rate & LED levels: HR range 10—300 BPM (±1 BPM); LED DC reference 100—3000 mV (1 mV step); LED AC reference 0.75—30 mV (0.01 mV step).
- PPG – Optical specs: Luminance 50—925 lux (measured at 5 mm diffusion), resolution 1/3000 full range, accuracy ±6%. Wavelength options: 525 / 660 / 880 / 940 nm (±10 nm).
- PPG – Timing & sampling: LED scan rate 50—40 kHz (Normal/Standalone); 10 kHz (Raw data). LED scan accuracy ±5 μs. PD sample rate 250 kHz (single channel) ±5 μs. PD response time typical 1 μs.
- PPG – Parameters: PI range 0.025%—30.000% (examples default 2.000%); AC level 0.75—30.00 mV; AC/DC lock options.
- PWTT mode: Time difference (PTTp, PTTf) 0—5999 ms (at 10 BPM; range reduces with HR); step 1 ms; accuracy ±1 ms.
- SpO2 Test Mode: SpO2 1%—100% (1% steps); SpO2 accuracy ±1% + DUT specified accuracy (comparison uses reference co-oximeters). Red irradiance ≈3.55 mW/m² (±15%); IR ≈6.65 mW/m² (±15%). LED wavelengths: Red 660 nm; IR 880 / 940 nm.
- Respiration: Respiration rate 4—200 BrPM (or 1—150 BrPM in PPG Respiration); impedance levels 1000/1500/2000 Ω; variation 1—5 Ω; apnea 0—60 s; apnea cycle 1—10 min.
- Raw data & automation: Loop playback enable/disable; selectable time scales (5/10/20 mm/mV); supports clinical waveform reproduction. SDK and automation tools for scripting and auto sequence testing.
- Physical / ordering: Main console part no. 100-AE00001 (Model: AECG100). Optional PPG modules: PPG-1R-525, PPG-2R-880, PPG-2R-940, PPG-2TF-660 2.0.
- Software & documentation: Optional add-on packs for IEC/YY automated setups, clinical waveform databases, SDK and assistant software for compliance and production testing.