Land: Vitryssland
Språk: ryska
Källa: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Synergetics, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
Synergetics
2022-02-18
Page 1 of 15 BL7600 Universal Viscous Fluid Control Pack EN Pacchetto universale per fluido viscoso IT Universal Viscous Fluid Control Pack DE Pack de contrôle de liquide visqueux universel FR Pack Universal de Control de Fluidos Viscosos ES Pacote Universal de Controle de Fluido Viscoso PT Универсальный комплект управления вязкой жидкости RU Bausch & Lomb GmbH, Brunsbütteler Damm 165-173, 13581 Berlin, Germany Synergetics, Inc., 3845 Corporate Centre Drive, O’Fallon, MO USA 63368-8678 Tel: (800) 338-2020 ©2019 Synergetics, Inc. 55203983 rev D (07/2019) Page 2 of 15 ENGLISH The Synergetics ® Universal Viscous Fluid Control Pack (BL7600) is to be used for posterior segment sugery with the Bausch + Lomb Stellaris ® PC or Stellaris Elite™, Alcon CONSTELLATION ® or DORC EVA ® . This device is for use by those trained in the use of ophthalmic surgical instrument systems. This would include surgical applications, appropriate surgical use, contraindications, etc. INDICATIONS FOR USE: The Synergetics ® Universal Viscous Fluid Control Pack is indidcated for the controlled injection or extraction of viscuous fluids during vitreoretinal surgery. CONTRAINDICATIONS: • Re-use and/or re-sterilization of this product by the customer. Re-use and/or re-sterilization can lead to patient cross contamination and significantly reduced device performance. • Repair of damaged product by the customer. • Use of this product if package integrity has been breached or compromised. KNOWN COMPLICATIONS: • Inflammation • Retinal Detachment • Proliferative Vitreoretinopathy • Infection • Cataract formation or progression • Glaucoma • Keratopathy • Ocular hypertension • Ocular hypotony Appearance of these complications is statistically rare. It is assumed that the user is adequately trained in the treatment of these known complications, as well as methods of avoidance. Synergetics, Inc. excludes all warranties, whether expressed, implied, or otherwise, to matters bey Läs hela dokumentet