দেশ: বেলোরুশিয়া
ভাষা: রুশ
সূত্র: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Covidien LLC, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
Covidien LLC
2022-11-21
A B C 1 3 4 E D AbsorbaTack™ Fixation Device with Absorbable Tacks 1075245 EN BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY. IMPORTANT! This booklet is designed to assist in using this product. It is not a reference to surgical techniques. This device was designed, tested and manufactured for single patient use only. Reuse or reprocessing of this device may lead to its failure and subsequent patient injury. Reprocessing and/or resterilization of this device may create the risk of contamination and patient infection. Do not reuse, reprocess or resterilize this device. DESCRIPTION The AbsorbaTack™ 5 mm device is a sterile, single use device for fixation of prosthetic material, such as mesh, to soft tissue. The tack is constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2. The device is offered with 10, 15, 20 or 30 absorbable tacks with a long shaft and 20 absorbable tacks with a short shaft. INDICATIONS The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair. CONTRAINDICATIONS 1. The device is not intended for use when prosthetic material fixation is contraindicated. 2. Do not use the AbsorbaTack™ fixation device on tissue(s) which cannot be inspected visually for hemostasis. 3. This device should not be used in tissues that have a direct anatomic relationship to major vascular stuctures. This would include the deployment of tacks in the diaphragm in the vicinity of the pericardium, aorta or inferior vena cava during diaphragmatic hernia repair. 4. Do not use in ischemic or necrotic tissue. ACTIONS The tack is made of the common copolymer poly(glycolide-co-L-lactide) (PGLA). This copolymer degrades and is absorbed by hydrolysis to glycolic acid and lactic acid which are then metabolized by the body. The absorption profile of poly(glycolide-co-L-lactide) (PGLA) in the first two weeks after initial implantation is minim সম্পূর্ণ নথি পড়ুন