Land: Hviderusland
Sprog: russisk
Kilde: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Abbott Medical, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
Abbott Medical
2022-09-09
TactiFlex™ Ablation Catheter, Sensor Enabled™ A ‑ TFSE ‑ D, A ‑ TFSE ‑ F, A ‑ TFSE ‑ J, A ‑ TFSE ‑ DD, A ‑ TFSE ‑ FF, A ‑ TFSE ‑ JJ, A ‑ TFSE ‑ DF, A ‑ TFSE ‑ FJ Instructions for Use ™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third-party trademark, which is property of its respective owner. Pat. http://www.abbott.com/patents © 2022 Abbott. All Rights Reserved. EN: ENGLISH TactiFlex™ Ablation Catheter, Sensor Enabled™ INSTRUCTIONS FOR USE DESCRIPTION The T actiFlex™ Ablation Catheter, Sensor Enabled™ is designed to facilitate electrophysiological mapping of the heart chambers and to transmit radiofrequency (RF) current to the catheter flexible tip electrode for intracardiac ablation. For ablation, the catheter is used in conjunction with an RF generator, an irrigation pump, and a dispersive pad (indifferent patch electrode). The TactiFlex™ Ablation Catheter, Sensor Enabled™ is compatible with introducers or sheaths with a minimum inner diameter of 8.5 F. The TactiFlex™ Ablation Catheter, Sensor Enabled™ features a tri-axial optical force sensor embedded in the distal section of the catheter that transmits contact force information to the TactiSys™ Quartz Equipment. The TactiFlex™ Ablation Catheter, Sensor Enabled™ is a sterile, single use catheter with a 7.5 F shaft and an 8 F distal section. It is constructed of thermoplastic elastomer material and noble metal electrodes. The catheter has a force and magnetic sensor. It has a fluid lumen connected to a flexible tip electrode for saline irrigation during the ablation procedure. For both bi ‑ directional and uni ‑ directional catheters, the tip curvature is manipulated by the control mechanism located on the handle at the catheter's proximal end. To adjust the curve of the distal tip on the uni ‑ directional catheter, push or pull the thumb control located on the handle. To adjust the curve of the distal tip on the bi ‑ directional catheter, use the actuator to defle Læs hele dokumentet