Изделия для рентгенэндоваскулярной хирургии: интродьюсер Super Sheath / Introducer Sheath Super Sheath в наборе и отдельных упаковках

국가: 벨라루스

언어: 러시아어

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

제공처:

Togo Medikit Co., Ltd., ЯПОНИЯ

수업:

изделия медицинского назначения

Manufactured by:

Togo Medikit Co.

승인 날짜:

2020-09-03

제품 특성 요약

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