User's Manual

BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
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CHAPTER 2
DESCRIPTION OF THE DEVICE
2.1 GENERAL OVERVIEW
The Bodyguardian Control Unit is a wearable battery power device intended for
use as a part of a Multi-Parameter Analysis System and is designed to be used by
a System Builder in a Multi-Parameter Analysis Application.
The Bodyguardian Control Unit is worn on the chest for the acquisition, recording
and transmission via a Bluetooth radio link of physiological parameters to
external host devices which can analyze by the suitable proper Application
Software and/or forward the data to additional storage elements or system.
The Bodyguardian Control Unit is also capable to record symptomatic and
asymptomatic events. The Bodyguardian Control Unit continuously records,
stores and periodically transmits the following physiological data:
Single lead ECG
Heart rate
Respiratory rate
Posture
Activity
Event marker
The Bodyguardian Control Unit is used for ambulatory monitoring of non-lethal
cardiac arrhythmias. Bodyguardian Control Unit is a wearable electronic device
that is worn on the chest. The device includes a disposable fabric adhesive
component that attaches to the subject and connects to the enclosed electronic
components.
The device will be worn intermittently or continuously for up to a 30-day period.
The recordings will be stored on the Bodyguardian Control Unit and transmitted
by the device via Bluetooth communication to an external Associated Device
(Android smartphone or other). The device is prescription only.
The Bodyguardian Control Unit recorder is intended to be used in a:
“Home Care” environment without clinicians surveillance.
“Clinic Care” environment with clinicians surveillance
The device is intended to be used by two different categories of end-users:
1. The patient which will use the device for continuous monitoring applications
and who will have to:
apply the device to the body by connecting the Bodyguardian Control Unit
to the disposable patch and attaching it to the selected body area;