OverviewThe HECG100 is a handheld 12‑lead ECG simulator designed for medical device R&D and compliance testing. It provides clinical waveform playback from detachable microSD, automated test sequences, EMI/EMS compatibility and a rechargeable battery to reduce mains interference during EMC testing.
Functions- Raw Data Playback: Store and play custom raw ECG data from included 32 GB microSD; device outputs a primary channel and derives other leads using fixed ratios to Lead II.
- Automated Quick Testing: Create and run custom test sequences without programming to speed verification and reduce setup errors.
- Advanced Signals & Add‑ons: Built‑in database of 32 arrhythmias; DC offset, noise injections, cardiac pacing and respiration simulation can be superimposed on ECG waveforms.
- Fast Start: Boot and run custom tests within seconds for efficient bench workflow.
- EMC‑Friendly Design: Includes CAL20110 waveform for IEC 60601‑2‑25 EMC testing; suitable for use alongside DUT in battery mode.
- ESD‑Protected Electrode Terminals: Protection up to 8 kV (contact) and 15 kV (air).
- Long Battery Operation: Up to 8 hours in normal use and up to 12 hours in power‑saving mode.
- Impact Resistance: Complies with IEC 60068‑2‑31 free‑fall test.
- Flexible Charging: USB‑C charging (USB‑PD supported) or external DC adapter.
Highlights- Automated sequences reduce repetitive setup and human error.
- Clinical raw data playback for realistic device performance evaluation.
- Signal add‑ons (DC offset, noise, pacing, respiration) to simulate real‑world conditions.
Compliance (EMC / Safety)- EMI/EMC: Meets FCC EMC P15B and EN61326‑1.
- ESD: IEC 61000‑4‑2 compliance — 8 kV contact, 15 kV air.
- Safety: Designed to meet IEC/EN61010‑1 requirements and operate alongside DUT during IEC 60601‑1‑2 testing when battery‑powered.
Ordering / Package (Standard Package)- Model: HECG100 (Handheld 12‑lead ECG Simulator)
- Package contents: HECG100 ×1; RCA to BNC cable (60 cm, black) ×1; USB Type‑C to Type‑C cable (44 cm, black) ×1; 32 GB microSDHC card ×1
Optional Accessories- DC 12 V power adaptor
- RCA male to BNC cable (60 cm, black)
- USB Type‑C to Type‑C cable (44 cm, black)
- 32 GB microSDHC card
Documentation and Tools (available)- Datasheet
- User Manual
- Release Notes for update tool
- Firmware Update Tool (software archive)
Specifications / Technical data- Heart rate accuracy: ±1%
- Amplitude accuracy: ±2%
- Frequency / pulse repetition accuracy: ±1%
- Pulse duration accuracy (excluding pacing): ±0.5 ms
- ECG duration accuracy: ±0.5 ms
- Pacing pulse width accuracy: ±5 μs
- Pacing pulse amplitude accuracy: ≤2 mV pulse: ±0.3%; >2 mV pulse: ±10%
- Pacing pulse characteristics: Rise/fall time 5 μs; Overshoot <1%; Settling time <1%
- Capacitor tolerance: ±5%
- Sample rate: 10 kHz ±0.05%
- RCA output amplitude range: ECG electrode output ×1000, max 10 V
- RCA output amplitude accuracy: ±1% for amplitudes ≥0.5 Vpp
- Lead output ratios (ref. Lead II = 100): Lead I 70; Lead II 100; Lead III 30; V1 24; V2 48; V3 100; V4 120; V5 112; V6 80
- Total harmonic distortion: 5%
- Signal‑to‑noise ratio: ≥60 dB
- DC offset: fixed ±1% or selectable ±300 / ±500 / ±1000 mV (may include up to 50 μVpp noise)
- Respiration simulation: Impedance baseline ±5%; variation ΔΩ ±(5% of setting) + 0.05 Ω
- ECG presets: Heart rate 10–300 BPM; Amplitude 0.1–5 mVpp; ST deviation −0.6 to 0.6 mV
- Auxiliary pulses: Sine/triangle/square/rectangle with multiple frequency/amplitude presets
- Signal add‑ons: DC offset, pacing (1–100 mV, 0.1–3 ms), drift (triangle 0.1 Hz, 4 mVpp), noise (50/60 Hz, white 1–10 mVpp), respiration (15/20/30/40 BrPM), baseline impedances 500/1000/1500 Ω, variation 1/2/5 Ω, apnea options 12s/22s/32s/continuous/off
- Raw data playback: max sample rate 10 kHz; repeated playback supported; detachable microSD (32 GB included)
- Operating temperature: 10°C–40°C; Storage: 0°C–50°C
- Humidity: 10%–90% non‑condensing
- Altitude: up to 2000 m
- Communications: USB Type‑C
- Power: 5 V DC; Battery charger: 5 V, 1 A
- Battery life: up to 12 h (power‑saving mode)
- Mechanical: ABS housing; Size (L×W×H) 18.0 × 12.8 × 5.5 cm; Weight 950 g
- Data capacity: 32 GB microSD included
- EMC standards: FCC EMC P15B; CE: EN61326‑1; IEC 61000‑4‑2/‑3/‑6/‑8 compliance