UbiqVue 1AXe/2AYe Holter system - Patient monitoring system, cardiac arrhythmia

Intended purpose

The UbiqVue Holter System is intended to capture, record, analyze and report both symptomatic and asymptomatic cardiac events, along with continuous electrocardiogram (ECG) information, for long-term monitoring. Following patient monitoring using the UbiqVue Wearable Biosensor, a comprehensive final report is generated from the entire ECG recording. Optionally, intended users may choose to generate an interim report from periodically or intermittently transferred ECG recording wirelessly from the UbiqVue Wearable Biosensor. Final & interim reporting is based on the beat-to-beat information extracted from the ECG recording. The UbiqVue Holter system is intended for non-critical, adult population, who are 18 years of age or older, at home and in healthcare settings, who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The reports are provided for review by the intended user to render a diagnosis based on their clinical judgment and experience.