Medical product "Apparatus of automatic cytoplasmapheresis", designed for automatic selective isolation of plasma, one or more cellular components from whole blood.
The device is designed for use in inpatient medical institutions, in blood service institutions.
Field of application - transfusiology.
Potential users: qualified medical personnel of public and private medical institutions.
Class depending on the potential risk of use - 2b according to GOST31508, order of the Ministry of Health of Russia from 06.06.2012 ? 4n.
The APPARATE corresponds to the type of climatic execution UHL 4.2 according to GOST15150.
In terms of perceived mechanical effects the device belongs to group 1 according to GOST R 50444.
In accordance with the classification of the product depending on its type and degree of protection against electric shock according to GOST R IEC 60601-1, the apparatus belongs to class II with a working part of type BF.
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