User's Manual

BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
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turn it on and off by using the appropriate button;
manage the recharging of the Bodyguardian Control Unit using the
dedicated charging station and power supply cable;
monitor the status of the device by looking at the led lights and colors
manage the devices by using the mobile phone application
2. The clinicians who will eventually subscribe the use of the device to the
patient and who will be in charge of:
Setting the initial thresholds and baselines for the parameters based on
patient’s conditions to personalize it (on Multi-Parameter Analysis System
side)
Reviewing the data acquired and transmitted from the device to the remote
server location (Multi-Parameter Analysis System) for diagnosis, trends
monitoring and in general clinical evaluations.
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 requires 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.
The “Body Guardian” Recorder is intended for adult use only with a weight
greater than 10 Kgs, without race exclusion. Patient with implanted device are
excluded to wear this device.
The Bodyguardian Control Unit is intended for System builder user in order to
create a complete remote ambulatory monitoring system including Bodyguardian
Control Unit kit, communication hub (Android smartphone or other) and System
Server.