MAVIG PORTEGRA2i, Instructions For Use Manual

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DE

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 6.0 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 Portegra2i 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 Portegra2i 

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.