videomed Truelink 4, Инструкция по эксплуатации

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System description
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80028008_030_B – 773625 – 2021-04-29
4 System description
4.1 Intended use
The Truelink 4 Video Management System is a medical video-
communication system used exclusively for displaying and
managing already existing audio-video sources, and to control an
operating light within the specifications established by the
manufacturer.
Intended use entails the following:
– The system is used exclusively for displaying and managing
already existing audio-video sources;
– Controlling signals via a touchscreen monitor;
– Distributing analogue and digital signals to different video
outputs;
– Export data into other devices (not part of the MD);
– Document the intervention through temporary archiving
– Exchange of information by video conference with the
operating room by sharing images and videos with the world
outside the room in high resolution;
– Regular maintenance of the MD in accordance with the defined
maintenance intervals by qualified service technicians;
– Initial operation by the operator;
– Repair and disposal of the MD must be performed by qualified
service technicians as required;
– To control the on, off and intensity of compatible surgical
lights.
Contraindications:
– The system shall not be used for the purpose of findings and
diagnostics;
– The system shall not be used for checking vital body functions;
– The system shall not be used to make reports;
– The product has not been designed for storing clinical data for
medical-legal purposes;
– The system shall not be used as a system of precision or
measurement of the function of life support;
– The system shall not be use to correct administration of drugs;
– The system shall not be used as a monitoring system of 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 for the patient;
– The system (monitors connected to the system) shall not be
used as the primary source of information.