User's Manual

BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
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CHAPTER 6
TECHNICAL CHARACTERISTICS
6.1 BODYGUARDIAN CONTROL UNIT
Product name Bodyguardian Control Unit
Description Active, non-invasive medical device
Intended use 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
Depending on the Environment, optional algorithms and/or thresholds (settable
via host software) can be used to generate measurements on an advisory basis for
patients. These are presented for:
Review and interpretation by the clinician, based upon knowledge of the
patient.
Results of the physical examination.
The data provided by the Bodyguardian Control Unit are exclusively intended to
be used by trained medical personnel to assist patients that require monitoring of
physiological parameters with reference of the followings context:
Screening of patients with symptoms suggesting arrhythmia over a
minimum 24-hour period.
Screening and off line evaluation of HR and Breath variability if the nature
of this variability cannot determine a Life-threatening for the patient.
Not intended to allow direct diagnosis or monitoring of vital physiological
processes parameters (for instance cardiachearth rate, respiration), where
the nature of variations is such that it could result in immediate danger to
the patient.
Not intended for therapeutic purpose.