Registration Number
0224U002948,
0123U105126
, R & D reports
Title
Sanitary and epidemiological evaluation: high-frequency welding electrocoagulator EKR300 dr Nic, high-frequency welding electrocoagulator MARK-AI.
popup.stage_title
Head
Semashko Petro V., Доктор медичних наук
Registration Date
18-03-2024
Organization
State Institution "OM Marzeev Institute of Public Health of the National Academy of Medical Sciences of Ukraine"
popup.description2
Sanitary and epidemiological assessment was carried out: high-frequency welding electrocoagulator EKR300 dr Nic, high-frequency welding electrocoagulator MARK-AI. Area of application and purpose: surgery.
Principle of operation: connection (welding) of pre-cut soft biological tissues of animals and humans using high-frequency current. There are no special regulatory documents for this product, therefore, during the hygienic assessment, the standards in force in hygienic practice are used. The analysis of the principle of operation and technical characteristics of the product allow us to consider it a potential source of EMF. The device is made of traditional materials and structural elements approved for use, which are typical for products of this type. The information provided about the High-frequency welding electrocoagulator EKR300 dr Nic, manufactured in accordance with TU U 32.5-40167303-003:2022 and the High-frequency welding electrocoagulator MARK-AI, manufactured in accordance with TU U 32.5-40167303-001:2016 revision No. 2, should be considered sufficient to conclude that the products comply with the sanitary legislation of Ukraine, subject to compliance with the requirements.
Product Description
popup.authors
Bezverkha Anna P.
Semashko Petro V.
popup.nrat_date
2024-03-18
