Катетер абляционный электрофизиологический: TactiFlex™ катетер для абляции, Sensor Enabled™ (номера моделей: A-TFSE-D, A-TFSE-F, A-TFSE-J, A-TFSE-DD, A-TFSE-DF, A-TFSE-FF, A-TFSE-FJ, A-TFSE-JJ)

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

Abbott Medical, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

класс:

изделия медицинского назначения

Производитель:

Abbott Medical

Дата Авторизация:

2022-09-09

Характеристики продукта

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