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The Inmedix® CloudHRV™ System is intended to acquire, display, and record electrocardiographic (ECG) information to measure heart rate variability (HRV) in adult patients (age 22 or above) with normal sinus rhythm and resting heart rate within 40 - 110 bpm. These measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV must be determined by the physician. Assessment is indicated for patients in a healthcare facility including a physician office or a hospital outpatient clinic where the patient is able to remain supine and still. The CloudHRV™ System is not indicated for use in a surgical suite or during transport. Normal sinus rhythm is determined by the physician. The ECG is not intended to be used to diagnose or monitor cardiovascular conditions. The device does not provide assessments of cardiovascular abnormalities/arrhythmias.

The Inmedix® CloudHRV™ System acquires approximately 5 minutes of 3-lead electrocardioaraphic (ECG) data from a patient lying supine and at rest to measure heart rate variability (HRV). The raw cardiac electrical signals are detected using four standard ECG electrodes applied to the wrists and ankles of the patient and a custom 4-lead wire (one reference) ECG cable assembly. The ECG data collected from the patient are transmitted to a cloud-based service hosted by Inmedix. where proprietary mathematical algorithms calculate HRV. The CloudHRV™ System outputs are used as an aid by clinicians who are accustomed to evaluating HRV as a part of their overall medical assessment.