Search Results

The HemoSphere Nano™ Monitor when used with a compatible non-invasive finger cuff is indicated for adult patients (≥ 18 years of age) in whom cardiac function parameters need to be evaluated as part of a patient's assessment. The HemoSphere Nano™ Monitor and compatible finger cuffs non-invasively measure blood pressure and associated hemodynamic parameters.

The HemoSphere Nano Monitor is a hand-held monitoring device that measures the arterial pressure waveform collected from a connected non-invasive finger cuff and displays blood pressure and derived hemodynamic parameters. These parameters are continuously displayed for up to a period of 10 minutes, serving as a series of spot-check or point-in-time measurements. As such, the device does not feature any physiological alarms. It is compatible for use with the single use Acumen IQ Plus finger cuff (AIQCA2; cleared via K243781).

The HemoSphere Nano Monitor utilizes the same principle of operation, algorithms, and mechanism for non-invasive monitoring hemodynamic parameters as the primary predicate, HemoSphere Advanced Monitoring Platform (K243781). When compared to the primary predicate, the subject device introduces a new hardware configuration with a smaller form factor. This new hardware configuration is powered by a rechargeable battery and features a smaller display to enable the product to be hand-held. Contrary to the predicate which incorporates a modular approach, the subject integrates all existing non-invasive technology (i.e., the ClearSight Module and Pressure Controller) into the HemoSphere Nano Monitor body itself to provide a unified and compact solution for non-invasive hemodynamic monitoring.

N/A

Ask a specific question about this device