MAVIG Portegra2, Инструкция по эксплуатации

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Operation
3.0 Operation
Initial use
These instructions for use apply after initial use as specified. The system/device must be
thoroughly cleaned and disinfected prior to initial use (see section 7.0 Cleaning/disinfection).
3.1 Identification of the system/device
The product can be clearly identified by using the type plate / product label attached on the
product. There you will find at least the following information:
Name of the product, manufacturer and adress, serial number
Information on other available Portegra2 products can be found on our web page at:
http://www.mavig.com/system-solutions/portegra2/
3.2 Intended use /
Reporting requirements according to regulation (EU) 2017/745
The Portegra2 system is a spring-supported, rotating and swivelling load‐bearing system that
allows payloads to be positioned in space in up to three dimensions. The use of Portegra2
systems is intended for professional health care facilities such as clinics, hospitals and medical
practices of group 0, 1 or 2 according to DIN VDE 0100-710 or HD 60364-7-710. The monitor
carrier system can be used by medical personnel such as doctors, nurses and assistants.
Radiation protective shields are used for the stationary protection of medical personnel against
ionizing radiation. The product is designed for applications in air‐conditioned health care
facilities such as clinics, hospitals and doctors’ surgeries. The product is used exclusively by
medical professionals such as physicians and assistants.
The carrier system is used to fasten monitor carrier to the ceiling.
It is the responsibility of the operator to ensure the device is safe for use and to provide
the user with due instruction in its operation and its use for the purpose intended.
Reporting requirements for medical devices
In accordance with the relevant legal regulations, serious incidents that have occured in
connection with a MAVIG medical device must be reported to MAVIG and to the responsible
national authorities in the country in which the user is active. In this sense, incidents are
reportable if the use of the medical device directly or indirectly led, might have let or might
lead to the death or the temporary or permanent serious deterioration of a patient’s, user’s
or other person’s state of health.