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The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, electrocardiography (ECG), heart rate variability (R-R interval), respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data is transmitted wirelessly to a central location where it is stored for analysis. The Vital Connect Platform can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients.

The VitalConnect Platform is a wireless data collection system that monitors physiological data and consists of the following sub systems: • VitalConnect Sensor (includes adhesive Patch and Sensor Module) • Relay Software Library • Server Software Library VitalConnect Platform sub-system includes: • VitalConnect Sensor a) Adhesive Patch The Patch is designed as a disposable self-adhesive interface to the body. b) Sensor Module Residing within the patch, the sensor module performs processing functions related to capture of physiological data and also performs bi-directional communication with the relay device. • VitalConnect Relay Software Library The Relay Software Library manages bi-directional communication between the Sensor Module and the Server Software Library and is installed on a relay device. • VitalConnect Secure Server Software Library The Server Software Library is installed on a central server, manages the upload, processing and storage of sensor data, as well as configuration of and notifications from the VitalConnect Platform. The VitalConnect Sensor continuously gathers physiological data from the person being monitored and then transmits encrypted data via a bi-directional relay to the central server. During normal operation, continuous wireless transmission occurs with a delay or latency of seconds between continuous data collection and transmission. However, for continuous transmission of data to a healthcare professional, a continuous connection is needed between the module, the relay, and the server. Data can be stored on the VitalConnect Sensor for several hours and then transferred once connectivity is reestablished. The VitalConnect Sensor is a battery-operated adhesive patch with integrated sensors and wireless transceiver module, worn on the torso to record heart rate, electrocardiography (ECG), heart rate variability (R-R interval), respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall).