Schiller FRED easyport TRAINER, Руководство пользователя

Страница: 19 / 44

FRED easyport TRAINER
User guide
Page 19
1 General points
•
The FRED easyport TRAINER device bears the CE mark in accordance with Directive
93/42/EEC relating to medical devices, and fulfils the fundamental requirements of Appendix I
of that Directive.
•
The device complies with standard EN 55011 class B.
• The safety of the user and trouble free device operation, shall only be guaranteed when
original SCHILLER parts are correctly used. Further, only the accessories mentioned in these
instructions for use or accessories that have been expressly authorised by SCHILLER may be
used. If the device becomes damp as a result of temperature variations, it may only be put
back into service once it is completely dry.
•
The manufacturer shall not be held liable for the safety, reliability and performance of the
device if:
• Assembly, extensions, adjustments, modifications or repairs are not performed by the
manufacturer or by personnel authorised by the manufacturer.
•
The electrical installation of the premises of use does not comply with locally applicable
regulations.
• The device is not used in accordance with the instructions for use.
•
The manufacturer may supply, on request, circuit diagrams, lists of components, descriptions,
calibration instructions or any other information, for use by the qualified technical personnel of
the user for repairing such parts of the device as have been stated to be repairable by the
manufacturer. Such supply shall not in any case constitute permission or approval to modify or
repair the device.
• This document describes a device type that complies with the safety standards applicable at
the time of printing. SCHILLER reserves all rights to the circuits, processes, names, software
and devices mentioned in these instructions for use.
•
The user guide is an integral part of the device and should always be kept near the device.
Close observance of the information given in the user guide is a prerequisite for using the
device as intended for and correct operation and ensures operator safety. Therefore, be sure to
read the complete user guide.
•
The user guide informs the device operator about the intended use, exact function, operation
and required preventive maintenance. It is not a substitute for a product training.
•
The quality assurance process used by SCHILLER is in compliance with international
standards ISO 9001 and ISO 13485.
• No part of these instructions for use may be reproduced without the written permission of
SCHILLER.
•
This device is not designed for any use other than that specifically described in this manual.
Such use may be hazardous.