?? ?????? ???? ??????? ?????? ?????? ????? ???? ????? ???? ? ???? ????? ??????. ???? ??? ??????? ????? ?? ???? ???? ????? ??? ?? ??????? ??? ?????? ?? ???? ?????? .The device shall perform as supposed through the producer. The medical device producer shall build and make the device in a means guaranteeing it could perform as supposed when used with