User Assistance Information; Device Description - VitalConnect Platform Instructions For Use & Information Manual

Instructions For Use (IFU) & Information Guide
This document provides instructions and information for the VitalConnect Platform, also referred as
Wireless physiological monitoring system. VitalConnect platform is developed as an Application
Programming Interface (API), intended to be used as a programming platform to allow mobile health care
services providers to develop user interface applications enabling the users (i.e. physician, caregiver,
patients) to view and/or access collected vital information. The platform consists of:
1. VitalConnect Sensor
2. VitalConnect Relay Software Library
3. VitalConnect Secure Server Software Library

User Assistance information

For additional information regarding the proper use of the VitaConnect Platform and mobile service
provider user interface, please contact the prescribing physician, caregiver, or health care provider.

Device Description

The VitalConnect Platform consists of the VitalConnect Sensor, Relay Software Library, and Server
Software Library. The VitalConnect Platform is accessible via an application program interface (API) that
allows authorized persons to receive data and notifications generated by the system.
The VitalConnect Sensor is a battery-operated adhesive patch with integrated sensors and wireless
transceiver, worn on the torso to record heart rate, electrocardiography (ECG), heart rate variability,
respiratory rate, skin temperature, fall detection, step count and posture. The sensor continuously gathers
physiologic data and then transmits the data via a Relay Software Library managed bi-directional relay
device to a central server controlled by the Server Software Library, where the data is stored for analysis
by healthcare professionals and researchers.
Authorized healthcare professionals can configure the system parameters via the API to generate
notification of changes in measured data. A notification is triggered when configured physiologic data
parameters are exceeded. Notification can be transmitted to a generic display device (i.e. smartphone,
tablet, PC or monitor).
VitalConnect Platform sub-systems include
1. VitalConnect Sensor
a) Patch
The Patch is designed as a low cost disposable self-adhesive interface to the body.
b) Sensor Module
Residing within the patch, the sensor module performs processing functions related to capture of
physiologic data and also performs bi-directional communication with the relay device.
IFU-01, Rev. A
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