Страна: Беларусь
Язык: русский
Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Covidien LLC, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
Covidien LLC
2022-10-26
2 A B C D E 3 4 F 1 14.1 mm 3.25 mm G 1 10.2 mm 2.4 mm 2 3 1 2 SFS™ Reusable Skin Stapler SM™ Skin Stapler Reload 1302746 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. The SM™ skin stapler reload was designed, tested and manufactured for single patient use only. Reuse or reprocessing of the SM™ skin stapler reload may lead to its failure and subsequent patient injury. Reprocessing and/or resterilization of the SM™ skin stapler reload may create the risk of contamination and patient infection. Do not reuse, reprocess or resterilize the SM™ skin stapler reload. DESCRIPTION SFS™ reusable skin stapler, together with SM™ skin stapler reload, places one staple each time the instrument handles are activated. The staples first penetrate the skin or fascia and are then formed, thus holding the tissue together. There are different staple sizes; each contained in its own skin stapler reload. INDICATIONS The SFS™ reusable skin stapler has application in abdominal, gynecological, orthopedic, and thoracic surgery for closure of skin and fascia. Additional uses include: closure of incisions in vein stripping, thyroidectomy, and mastectomy procedures; closure of scalp incisions and for scalp flap hemostasis; skin grafts; plastic and reconstructive surgery. CONTRAINDICATIONS 1. Staples can be applied directly over bone or viscera; however, during application there must be distance of not less than 6.5 mm (slightly more than 0.25 inches) from the surface of the skin or fascia to the underlying bone, vessel, or viscera. When using the regular skin staple, the distance required can be slightly less, but at least 4.5 mm. If these distances cannot be obtained by lifting the tissue during application, use of the skin or fascia staples is contraindicated. WARNINGS AND PRECAUTIONS 1. Do not immerse the instruments in saline solution. 2. Reusable devices must be carefully inspected prio Прочитать полный документ