פד המוסטטי ג'לטיני סופג SMI, 80X50X10 ממ, 1 יחידה

INSTRUCTIONS FOR USE:
This information is not a reference to surgical techniques. It is designed to assist in using this product.


SMI-SPON - Absorbable Haemostatic Gelatin Sponge is a sterile malleable, water-insoluble, porcine gelatin absorbable sponge intended for haemo-static use by applying to a bleeding surface. SMI-SPON is non-pyrogenic
SMI-SPON is a surgical haemostatic sponge, manufactured from highly purified first grade gelatin material for use in various surgical procedures.
When implanted in vivo and used in appropriate amounts, it is completely absorbed within 3-4 weeks. When applied to bleeding mucosal regions, it liquefies within 2 to 5 days.
SMI-SPON gelatin sponges have a porous structure which activates the thrombocytes at the moment blood comes in contact with the matrix of the sponge. This causes the thrombocytes to release a series of substances which promote their aggregation at the same time as their surfaces change character, thus enabling them to act as a catalyst for the formation of the fibrin.


INDICATIONS:
SMI-SPON can be effectively used in various surgeries for haemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.


CONTRA-INDICATIONS:
SMI-SPON should not be used:
? in closure of skin incisions because it may interfere with the healing of skin edges
? in patients with known allergies to porcine collagen
? in intravascular compartments because of the risk of embolization
? in conjunction with methyl methacrylate adhesives
? in conjunction with autologous blood salvage circuits
? for the primary treatment of coagulation disorders
? in the presence of infection
? for controlling post-partum bleeding or menorrhagia
? in instances of pumping arterial haemorrhage
? where blood or other fluids have pooled or in cases where the point of haemorrhage is submerged



SMI-SPON Sponge will not act as a tampon or plug in a bleeding site, nor will it close off an area of blood collecting behind a tampon. The safety and effectiveness of SMI-SPON have not been established:
? for use in ophthalmic procedures
? in children and pregnant women

The safety and effectiveness for use in urological procedures have not been established through a randomized clinical study. In urological procedures, gelatin sponge should not be left in the renal pelvis, renal calyces, bladder, urethra or ureters to eliminate the potential foci for calculus formation.
Although the safety and effectiveness of the combined use of gelatin sponge with other agents such as topical thrombin, antibiotic solution or antibiotic powder have not been evaluated in controlled clinical trials, if in the physician's judgement, concurrent use of topical thrombin or other