12-Lead ECG / EKG System

GE Healthcare — MAC 5500 HD

Clinical Purpose

Resting 12-lead ECG for cardiovascular safety screening and QTc monitoring.

Cardiovascular safety monitoring is a regulatory requirement for Phase II-IV trials.

Applications

Pre-study cardiovascular screening, qTc interval monitoring, arrhythmia detection.

Compliance

CFR 21 Part 11 compliant digital records, automatic QT/QTc calculation

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