Peri-Strips Dry® - Synovis Surgical Innovations

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SYMBOL DEFINITIONS: Do not reuse STERILE Consult Instructions for Use Sterile Sterilized using irradiation Sterilized using steam heat This product is treated with sodium hydroxide. This product is derived from USDA inspected cattle. MADE IN THE U.S.A. Made in the U.S.A. CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician. REF Catalog number Use by date LOT Lot number Compatible stapler models Manufacturer Authorized Representative in the European Community SSI part number. SSI tracking number. SSI internal code. ID SSI internal code. DESCRIPTION: Peri-Strips Dry ® Staple Line Reinforcement (PSD) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. One (1) tube of PSD Gel (Gel) is provided for every two (2) pouches of PSD. The Gel is used to create a temporary bond between the PSD buttress and the surgical stapler jaws until the stapler is positioned and fired. Each PSD loading unit and each Gel tube is packaged sterile in a separate pouch. 4 INDICATIONS FOR USE: PSD is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed. PSD can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures. PSD can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon and colorectal procedures. CONTRAINDICATIONS: The use of PSD is contraindicated in patients with known sensitivity to bovine material. ADVERSE REACTIONS: As with any surgical procedure, adverse reactions are possible and include but are not limited to: infection, rejection, erosion, and allergic reaction. WARNINGS: Do not re-sterilize. Discard all open unused components. Do not use product if there is damage to the pouch or seals. Ensure the staple line is completely covered with the buttress, or inadequate coverage after firing may result. PSD is not designed, sold, or intended for use except as indicated; doing so may result in surgical complications. Synovis products differ; substitution of one product for another product may reduce product performance. Clinical experience with glutaraldehyde-fixed porcine xenograft heart valves indicates that fixed tissues may be subject to late attack by the body and subsequent tissue deterioration. In a like manner, glutaraldehyde-fixed bovine pericardium may be subject to later deterioration. The benefits of the use of this tissue in cardiovascular repair or repair of soft tissue deficiencies must be weighted against the possible risk of aneurysm or hemorrhage or patch weakening resulting from tissue deterioration.
Glutaraldehyde-treated bovine pericardium may undergo accelerated calcific infiltration in patients with high calcium metabolic activity (e.g., children). This may not be a concern where the patch is exposed to systolic pressures. When used to correct simple complete transposition of the great arteries with pericardium augmentation of the pulmonary venous channel, bovine pericardium has been reported to demonstrate calcification, inflammation, and formation of fibrous tissue which obstructed pulmonary venous flow. When used in animal studies for pericardial closure, bovine pericardium has been reported to show signs of calcification. Animal studies have reported histological signs of deterioration of implanted bovine pericardium. Findings include active phagocytosis with accompanying chronic inflammatory infiltrate and the formation of giant cell infiltrate at the interface between bovine pericardium and surrounding host tissues (with focal degradation of implant collagen) consistent with a host-versus-graft reaction. CAUTIONS: Use care when removing loading unit components from the stapler to prevent buttress dislodgement. Do not get the buttress wet before applying Gel, or the buttress may not adhere to the stapler properly. Ensure the anvil and cartridge sides of the loading unit are on the corresponding stapler jaws or the buttress may not adhere to the stapler properly. Final tissue compression, including PSD, must meet the range specified by the stapler manufacturer; this is especially important if staple firings are overlapped. PSD increases the total thickness of the area stapled by 0.5mm - 1.5mm (0.02" - 0.06"). Follow Instructions for Use supplied by the stapler manufacturer. Do not use PSD contrary to the stapler manufacturer's instructions. The cartridge and anvil sides of the PSD loading unit differ; substitution of one side for the other may interfere with alignment and adherence of the buttress strips. INSTRUCTIONS FOR USE: LOADING STAPLER FOR ALL STAPLER MODELS Note: Each model of PSD has been designed specifically for the stapler models indicated on the label; verify that the correct model of PSD has been selected. 5 Note: Loading technique for PSD varies. Follow the appropriate technique as indicated below. 1. Open the outer PSD pouch. 2. Aseptically remove the inner pouch and place in the sterile field. 3. Inspect the pouch. Do not use if the pouch is damaged or if the seals are not intact. 4. Open the inner PSD pouch and remove the PSD loading unit by using aseptic atraumatic techniques. 5. Inspect the Gel pouch. Do not use if the pouch is damaged or if the seals are not intact. 6. Open the Gel pouch and aseptically place Gel in the sterile field. 7. Break off the metal tip of the Gel tube. 8. Attach the plastic Gel Tip to the Gel tube by pushing it down over the top of the Gel tube. 9. Apply a continuous thin Gel bead onto each buttress strip (See Figure 1). Caution: Do not get the buttress wet before applying Gel or the buttress may not adhere to the stapler properly. 10. Ensure that the jaws of the stapler are clean and dry before inserting the PSD loading unit. Caution: Final tissue compression, including PSD, must meet the range specified by the stapler manufacturer. This is especially important if stapler firings are overlapped. PSD increases the total thickness of the area stapled by 0.5mm - 1.5mm (0.02”- 0.06”). 11. Identify the anvil (ANV) and cartridge (CART) sides of the PSD loading unit. Note: For ENDO GIATM UNIVERSAL stapler models skip to step 19. LOADING STAPLER FOR ALL STAPLER MODELS EXCLUDING ENDO GIATM UNIVERSAL MODELS 12. Position the open stapler onto the stapler loading unit (See Figure 2). 13. Ensure the anvil and cartridge sides of the loading unit are on the corresponding stapler jaws or the buttress may not adhere to the stapler properly. Note: The cartridge and anvil sides of the PSD loading unit differ; substitution of one side for the other may ENGLISH
Page 1 and 2: INSTRUCTIONS FOR USE...............
Page 3: Peri-Strips Dry ® Figures 1-7 Figu
Page 7 and 8: DEFINITION DES SYMBOLES : Ne pas r
Page 9 and 10: chevauchent. PSD augmente l’épai
Page 11 and 12: SYMBOLBEDEUTUNGEN: Nicht wiederverw
Page 13 and 14: 6. Den Beutel mit dem Gel öffnen u
Page 15 and 16: DEFINIZIONI DEI SIMBOLI: Non riutil
Page 17 and 18: Attenzione: La compressione finale
Page 19 and 20: DEFINICIÓN DE LOS SÍMBOLOS: No re
Page 21 and 22: CARGAR LA GRAPADORA PARA TODOS LOS
Page 23 and 24: SYMBOOL DEFINITIES: Niet opnieuw ge
Page 25 and 26: Let op: Uiteindelijke weefselcompre
Page 27 and 28: SYMBOL DEFINITIONER: Må ikke genbr
Page 29 and 30: Bemærk: For alle ENDO GIA TM UNIVE
Page 31 and 32: SYMBOLDEFINITIONER : Återanvänd e
Page 33 and 34: LADDA STAPLERN FÖR ALLA STAPLERMOD
Page 35 and 36: Fikserte implantater av svineopprin
Page 37 and 38: İŞARET TANIMLARI: Tekrar kullanma
Page 39 and 40: ENDO GIA TM EVRENSEL MODELLERİ HAR
Page 41 and 42: Το PSD δεν σχεδιάζετ
Page 43 and 44: 24. Βεβαιωθείτε ότι
Page 45 and 46: Glutaraldehydillä käsitellyt naud
Page 47 and 48: DEFINIÇÕES DOS SÍMBOLOS: Não re
Page 49 and 50: PSD aumenta a espessura total da á
Page 51 and 52: DEFINIŢIILE SIMBOLURILOR: Nu reuti
Page 53 and 54: Precauţii: Grosimea finală a ţes
Page 56:
A Division of Synovis Life Technolo
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Peri-Strips Dry® - Synovis Surgical Innovations

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