Approvals for the Russian Federation for the Neurostimulation Device NeySi-3M with accessories

• Certificate for neurostimulator «NeySi-3M» for Russia. 
  
  • Appendix to the certificate for neurostimulator NeySi-3M Certified in accordance with the order of Roszdravnadzor № 3664-Pr/11 dated June 24, 2011, approved for import, sale and use in the Russian Federation. Official representative of NPP «VEL», which supplies NeySi-3M in the Russian Federation , is LLC «Medical Systems».
    Contact Information:
    455091, Chelyabinsk, st. Timiryazeva, 24,
    Phones: +7-351-266-76-32 , +7-909-081-73-61
    e-mail: info@m-sy.ru

• Certificate of conformity of the quality management system DSTU EN ISO 13485: 2018 (EN ISO 13485: 2016, IDT; ISO 13485: 2016, IDT), operating at the enterprise PE «VEL».
• Certificate of compliance of the neurostimulation system NeySi-3M with the requirements of the Technical Regulations regarding active implantable medical devices, approved by the Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 № 755. This technical regulation is based on Directive 90/385 / EEC relating to active implantable medical devices (Directive AIMDD ).

Certificate for neurostimulator «NeySi-3M» for Ukraine

— Certificate of Conformity: BB series № 094821. The device for electrical stimulation, neurostimulator NeySi-3M, is certified by the State Committee of Ukraine for technical regulation and consumer. 
— Clinical trial protocol. Clinical trials of the implantable neurostimulator are completed NeySi-3M. Technical conditions TU U 33.1-30972877-001:2008.
— Registered Specifications for the implantable neurostimulator NeySi-3M. Certificate of state registration № 7439/2008.
— Received a certificate of state registration NeySi-3M. NeySi-3M is included in the State Register of Medical Equipment. The use of NeySi-3M in medical practice is allowed.

Certificate of qualification tests «NeySi-3M».

National Medical Academy of Postgraduate Education. Department of Neurosurgery. Report from 11.12.07.

Protocol of preclinical tests for the Device for electrical stimulation «NeySi-3M» as part of the «Generator block with transmitting antenna» and «Receiving antenna with electrodes» (according to TU U 33.1-30972877-001:2006).

Acceptance technical test report

Toxicity test report of the Receiving antenna with electrodes, which is an integral part of the Electrostimulation Device «NeySi-3M» Conclusion of the State Sanitary and Epidemiological Expertise on Specifications «Electrostimulation device «NeySi-3M»» TU U 33.1-30972877-001:2006.

Conclusion of the State Sanitary and Epidemiological Expertise on the Device for electrical stimulation «NeySi-3M» as part of the «Generator block with transmitting antenna» and «Receiving antenna with electrodes» (according to TU U 33.1-30972877-001:2006).

Instructions for using the medical device NeySi-3M.

A method of treating patients with paralysis of the brachial plexus by stimulating the spinal cord columns with implanted (implanted) electrodes.

Information about a medical and technical innovation that is recommended for implementation.

Extract from the minutes of the meeting of the Academic Council of the Institute of Neurosurgery named after Academician A. P. Romadanov on the results of the clinical use of implantable neurostimulators.

Institute of Neurosurgery named after Academician A. P. Romodanov AMS of Ukraine. Department of Reconstructive Neurosurgery. Installation of electrodes of the NeySi-3M neurostimulator on the damaged spinal cord. Photos.

The use of the neurostimulator NeySi-3M in the treatment of Volkmann’s ischemic contracture. Report.