Land: Vitryssland
Språk: ryska
Källa: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
DePuy Mitek, Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
DePuy Mitek
2022-05-12
P/N: 116043 REV: B ISSUED 01/2020 © DEPUY SYNTHES 2020. ALL RIGHTS RESERVED. MANUFACTURED FOR DEPUY SYNTHES BY: GYRUS MEDICAL PN0011069-AB 225031 VAPR ® COOLPULSE ® CURVE AND 225032 VAPR ® COOLPULSE ® CURVE XL SUCTION ELECTRODES For use only with the VAPR VUE ® Generator 2 ENGLISH VAPR ® COOLPULSE ® CURVE AND VAPR ® COOLPULSE ® CURVE XL SUCTION ELECTRODES Please read all information carefully prior to use, giving special attention to the User Manual provided with the VAPR VUE ® Radiofrequency (RF) System. VAPR VUE System components are designed for use as a single system. Failure to follow instructions may lead to improper functioning of the device causing electrical or thermal injury. SYSTEM DESCRIPTION The VAPR VUE Radiofrequency (RF) System is designed for arthroscopic surgical procedures. The system consists of a high frequency electrosurgical generator and may include a reusable handpiece with connector cable, disposable electrodes, and alternative disposable electrodes with integrated connector cable. Also available are hand controls, a footswitch, and a wireless footswitch alternative. The components are designed and intended to be operated as a single unit. Use only VAPR ® electrodes and accessories with the VAPR VUE RF system. DEVICE DESCRIPTION The VAPR Electrodes are soft tissue ablation and hemostasis/coagulation devices intended for use with the VAPR VUE RF System. The VAPR ® COOLPULSE ® Curve and COOLPULSE ® Curve XL Electrodes suction capabilities enhance the efficiency of the electrode and extend the utility of the system by assisting in the removal of bubbles and debris created during activation within the operating site. VAPR electrodes are intended to be used by an orthopedic surgeon in a surgical setting. INDICATIONS The VAPR Electrodes for use with the VAPR VUE Radiofrequency System are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery. CONTRAINDICATIONS The VAPR VU Läs hela dokumentet