Страна: Беларусь
Язык: русский
Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Togo Medikit Co., Ltd., ЯПОНИЯ
изделия медицинского назначения
Togo Medikit Co.
2020-09-03
Internal Barcode DBT13 REV8 2017-10 ©2015 Togo Medikit Co., Ltd. All rights reserved. _Super Sheath _ Introducer Sheath Instructions for USE CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Please read this manual carefully before using the product. INDICATIONS: The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the peripheral and coronary vasculature. PRODUCT DESCRIPTION: The Super Sheath consists of a sheath and a dilator. The one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The hubs, color-coded by French size, have a hemostatic valve built in to minimize blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The side-port extension may be used for fluid and medication administration as well as blood sampling. The Super Sheath has a suture wing. The suture wing is a small projection near the hub with a hole in it to secure placement of the sheath. The Super Sheaths arc available in 4-9 French sizes (1.3 mm -3.0mm) in 7, 11, and 25 cm lengths. The Super Sheaths may be ordered with a mini guidewire. Mini guidewires arc available in 45 cm and 80 cm lengths and in 0.035” (0.889 mm) and 0.038” (0.965 mm) diameters. The French size and color coding refers to the size of the largest interventional device that will pass through the sheath FRENCH SIZE: COLOR: 4.0F (1.3mm): Red 5.0F (1.7mm): Gray 6.0F (2.0mm): Green 7.0F (2.3mm): Orange 8.0F (2.7mm): Blue 9.0F (3.0mm): Black CONTRAINDICATIONS None known WARNING: Contents supplied STERILE using an ethylene oxide (EO) Process. Do not use if sterile barrier is damaged. Inspect device for damage. If any damage is found, do not use the device and call your Boston Scientific representative. For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure whi Прочитать полный документ