Device Description
The VitalPatch
®
device (VitalConnect Sensor) is a component of the VitalConnect Platform. The
VitalPatch device is a wireless, battery-operated wearable biosensor, worn on the torso to record heart
rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin temperature, fall
detection, activity (including step count) and posture (body position relative to gravity including fall
detection). The VitalPatch device continuously gathers physiological data from the person being
monitored and then transmits encrypted data via bi-directional communication to the Relay device when
in range of the Relay device. The encrypted wireless data provided by the VitalPatch device may be
downloaded from the Relay device for storage, or integrated into a Third-Party Relay Application via the
APIs of the Relay Software Library. Additionally, wireless data may be transferred to and stored on an
optional Secure Server for future analysis if there is an active server connection. The data provided by the
VitalPatch device is intended to aid caregivers in making diagnoses by providing additional information to
standard of care patient monitors.
During normal operation, data is collected by the VitalPatch device and transmitted immediately to the
Relay device. A continuous connection is needed between the VitalPatch device and the Relay device in
order to facilitate continuous data transmission. The continuous wireless transmission of data occurs with
a latency of seconds between data collection and transmission.
Indications for Use
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 can
include 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 are transmitted wirelessly from the VitalConnect Sensor for storage and analysis. The VitalConnect
Platform can include the ability to notify healthcare professionals when physiological data fall 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 are
intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not
intended for use on critical care patients.
Contraindications
•
The VitalPatch device is not intended for use on users who have implanted defibrillators or
pacemakers.
•
The VitalPatch device is not intended as a stand-alone diagnostic monitor, but the data may be
applicable for use in diagnosis.
Warnings
•
The VitalPatch device is a secondary, adjunct patient monitor and is not intended to replace existing
standard-of-care patient monitoring practices.
•
Depending on wireless connectivity, a temporary interruption of data transmission is possible, which
may impact continuous or real-time monitoring. Data will be stored on the device for transfer once
connectivity is reestablished.
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