System description
22
80028681_002_C – 774259 – 2021-09-01
4
System description
4.1
Intended use
The Helion Video Management System is a medical video
communication system used exclusively to display and manage
existing audio-video sources, and to control an operating light
within the specifications established by the manufacturer.
The intended use requires the following:
–
The system is used exclusively to display and manage existing
audio-video sources;
–
Signals are controlled via a touchscreen monitor;
–
Analogue and digital signals are distributed to different video
outputs;
–
Data are exported to other devices (not part of the MD);
–
Interventions are documented via temporary archiving
–
Information is exchanged by video conference with the
operating theatre by sharing high resolution images and videos
with the world outside the room;
–
The MD is regularly maintained by qualified service technicians
in accordance with the defined maintenance intervals;
–
It is initially operated by the operator;
–
The MD must be repaired and disposed of as required by
qualified service technicians;
–
Control of turning on, off and intensity of compatible surgical
lights.
Contraindications:
–
The system shall not be used for findings and diagnostics;
–
The system shall not be used to check vital body functions;
–
The system shall not be used to make reports;
–
The product has not been designed to store clinical data for
medical-legal purposes;
–
The system shall not be used as a system for precision or
measurement of life support function;
–
The system shall not be use to correct the administration of
medicinal products;
–
The system shall not be used as a system for monitoring the
patient's condition;
–
The system shall not be used as an alarm system;
–
The system shall not be used for a specific treatment. In the
event that incorrect information may lead to inappropriate
treatment of the patient;
–
The system (monitors connected to the system) shall not be
used as the primary information source.
