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12-64 Lead High-Density ECG Recorder

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.

⚡ TFDA Class II E.2340 · Submission
CardiGemini Multi-Lead ECG Recorder — 12-64 lead high-density system
Design Highlights

Design Highlights

High-Density Lead Layout

Beyond standard precordial + limb leads, our layout adds lateral and posterior coverage to detect local ischemia.

High-Res Signal Acquisition

3 kHz synchronous sampling (1 kHz standard) preserves micro ST-T variations for downstream AI analysis.

48-Hour Continuous Recording

32 GB on-device storage and 48-hour battery — supporting in-hospital monitoring and home use cases.

IP54 Water-Resistant

IP54-rated for water and dust resistance, with cable design that minimizes patient discomfort.

Encrypted Wireless Upload

Dual Bluetooth + Wi-Fi modes with AES-256 encrypted cloud upload — aligned with medical data security standards.

IEC 60601 Compliant

IEC 60601-1 safety and 60601-1-2 EMC certified, with medical-grade biocompatible materials.

Specifications

Technical Specifications

Hardware

Channels12 / 24 / 48 / 64 leads
Sample Rate500 / 1000 Hz (up to 3 kHz sync)
Storage32 GB SD
Data FormatEDF / BDF
ConnectivityBluetooth 5.0 + Wi-Fi 802.11 a/b/g/n/ac
Battery48-hour continuous recording
Ingress ProtectionIP54
Wearable DesignPatch / Vest configurations

Compliance & Safety

Electrical SafetyIEC 60601-1
EMCIEC 60601-1-2
BiocompatibilityISO 10993 (skin contact)
Data EncryptionAES-256 · HIPAA / GDPR-aligned
QMSISO 13485
Risk ManagementISO 14971
Regulatory ClassTFDA Class II (E.2340 ECG Recorder)
FDA Pathway510(k) (planned 2027)
Use Cases

Clinical Applications

ED Chest Pain Triage

Rapid HD-ECG acquisition in the emergency department, paired with Vision Express AI for instant 3D ischemia mapping.

In-Hospital Monitoring

48-hour pre/intra/post-op continuous monitoring on cardiac wards, with real-time AI ST-change detection and cloud notification.

Home Cardiac Tracking

Short-session home recording for post-revascularization patients, with daily cloud upload for remote physician review.

Bringing this system to your institution?

We offer outright system sales for medical centers and SaaS subscriptions for clinics — including full physician training.

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