Country: Belarus
Language: Russian
Source: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Covidien LLC, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
Covidien LLC
2022-12-05
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 GIA™ stapler with Tri-Staple™ technology places two triple staggered rows of titanium staples and simultaneously cuts and divides tissue between these two triple rows. The GIA™ stapler and cartridges with Tri-Staple™ technology are currently available in 60 mm and 80 mm length. The GIA™ stapler with Tri-Staple™ technology is currently available in two staple sizes to accommodate various tissue thicknesses: medium/thick and extra thick. Staplers with medium/thick staple size (purple) deploy three height-progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples. Staplers with extra thick staple size (black) deploy three height progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples. Please refer to the “SPECIFICATION CHART” for availability of staple sizes and cartridge lengths. Each GIA™ stapler with Tri-Staple™ technology may be reloaded up to 7 times for a total of 8 firings per instrument. INDICATIONS The GIA™ stapler with Tri-Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis. CONTRAINDICATIONS 1. The instrument should not be used on tissue such as liver or spleen where compressibility is such that closure of the instrument would be destructive. 2. Tissue thickness should be carefully evaluated before firing any stapler. Refer to “SPECIFICATION CHART” and the “Tissue Compression Requirements” section. 3. “Tissue Compression Requirement” refers to the tissue c Read the complete document