IFU for Bioglue Surgical Adhesive (Outside USA)
Instructions for Use Syringe BioGlue® Adhésif BioGlue® Collante Chirurgico Adhesivo Quirúrgico Chirurgical Mode Chirurgischer Klebstoff BioGlue® Istruzioni d’uso BioGlue® Instrucciones d’emploi Seringue Gebrauchsanwei sung Siringa de Uso Jeringuilla Spritze BioGlue® Adesivo BioGlue® Kirurgisk BioGlue® Kirurgisk Lim BioGlue® Vävnadslim Cirúrgico Instruções de Klæbemiddel Bruksanvisning Sprøyte Bruksanvisning Spruta Utilização Seringa Brugsanvisning Sprøjte Χειρουργική συγκολλητική BioGlue® Cerrahi Chirurgické adhezivum BioGlue® ουσία BioGlue® Οδηγίες Yapışkan Kullanım BioGlue® Návod k použití Chirurgische Kleefstof χρήσης Σύριγγα Talimatları Şırınga Stříkačka Gebruiksinstructies Spuit Chirurgické Lepidlo BioGlue® Sebészi Klej Chirurgiczny Хирургический клей BioGlue® Návod na Szövetragasztó BioGlue® Sposób Użycia BioGlue® Инструкция по Použitie Striekačka Használati útmutató Strzykawka применению Шприц Fecskendő CryoLife, Inc. 1655 Roberts Boulevard, NW • Kennesaw, Georgia 30144 • USA • +1 (770) 419-3355 • Fax +1 (770) 590-3753 http://www.cryolife.com 25°C 0°C L6313.009 Rev (07/2010) ENGLISH PRODUCT DESCRIPTION BioGlue® Surgical Adhesive is composed of bovine serum albumin and glutaraldehyde. The product’s two components are mixed within the applicator tip of the syringe during application to tissue. Polymerization of the surgical adhesive begins immediately upon application, reaching bonding strength within 2 minutes. INDICATIONS • Do not peel away BioGlue from an unintended site, as 3. While firmly grasping the syringe, nose upward, BioGlue Surgical Adhesive is indicated for use as an this could result in tissue damage. turn the cap 90° counterclockwise and remove the adjunct to standard methods of surgical repair (such • An animal study12 has shown that the circumferential cap by rocking it from side-to-side. Align the tip with as sutures, staples, electrocautery, and/or patches) to application of BioGlue restricts dilatation on growing the syringe using the corresponding notches on bond, seal, and/or reinforce soft tissue.
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