Patch / vest design covering anterior, lateral, posterior, and limb leads — with 3 kHz synchronous sampling to capture subtle ischemic signals invisible to standard 12-lead ECG.
Beyond standard precordial + limb leads, our layout adds lateral and posterior coverage to detect local ischemia.
3 kHz synchronous sampling (1 kHz standard) preserves micro ST-T variations for downstream AI analysis.
32 GB on-device storage and 48-hour battery — supporting in-hospital monitoring and home use cases.
IP54-rated for water and dust resistance, with cable design that minimizes patient discomfort.
Dual Bluetooth + Wi-Fi modes with AES-256 encrypted cloud upload — aligned with medical data security standards.
IEC 60601-1 safety and 60601-1-2 EMC certified, with medical-grade biocompatible materials.
| Channels | 12 / 24 / 48 / 64 leads |
| Sample Rate | 500 / 1000 Hz (up to 3 kHz sync) |
| Storage | 32 GB SD |
| Data Format | EDF / BDF |
| Connectivity | Bluetooth 5.0 + Wi-Fi 802.11 a/b/g/n/ac |
| Battery | 48-hour continuous recording |
| Ingress Protection | IP54 |
| Wearable Design | Patch / Vest configurations |
| Electrical Safety | IEC 60601-1 |
| EMC | IEC 60601-1-2 |
| Biocompatibility | ISO 10993 (skin contact) |
| Data Encryption | AES-256 · HIPAA / GDPR-aligned |
| QMS | ISO 13485 |
| Risk Management | ISO 14971 |
| Regulatory Class | TFDA Class II (E.2340 ECG Recorder) |
| FDA Pathway | 510(k) (planned 2027) |
Rapid HD-ECG acquisition in the emergency department, paired with Vision Express AI for instant 3D ischemia mapping.
48-hour pre/intra/post-op continuous monitoring on cardiac wards, with real-time AI ST-change detection and cloud notification.
Short-session home recording for post-revascularization patients, with daily cloud upload for remote physician review.
We offer outright system sales for medical centers and SaaS subscriptions for clinics — including full physician training.
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