Both Quickclean® and Surgiclean® have got CE Mark
100% Potato Starch
Surgiclean® Absorbable Hemostatic Particles (Here after called Surgiclean® ) are spherical or ellipsoidal microporous microspheres with spatial reticular microstructure, good biocompatibility, and diameter of 30.8μm-97μm, prepared with potato starch as the raw materials using the emulsification and crosslinking technology; they are aseptic and pyrogen-free, and contain no components of animal origin or human origin; they are packaged in polyethylene sprayers sealed by screw caps, conditioned in a blister of PVC, sterilized with ethylene oxide and finally packaged into carton box.
Surgiclean® have the function of a hydrophilic molecular sieve, can absorb and lock the water several times over weighting themselves instantly to form gels, and form gel mixtures around particles by condensing visible components in the blood outside the gels, such as platelets, red blood cells, albumins, thrombin and fibrinogen, thus promo ting instant clot forming; in addition, the blood at the bleeding sites is concentrated rapidly, thus resulting in concentration of platelets, initiating the coagulation mechanism, and accelerating the natural coagulation; Surgiclean® apply certain pressure on the peripheral vessel to promote the hemostasis after absorbing water and expanding; Surgiclean® form waterproof gels after absorbing water, and the polysaccharide particles can block off the wounds and promote the blood coagulation.
Surgiclean® hemostatic microsphere degradation in the bodies initiates after hemostasis and finishes within 14 days. The Surgiclean® are decomposed into maltose and glucose by amylase andα-glucoside to form water and carbon dioxide finally, which are absorbed by the circulation system and expelled from the bodies.
[Scope of Application]:
The product is intended to be used for surgeries such as cardiovascular surgery, thoracic surgery, hepatobiliary surgery, bone surgery, general surgery, burns, plastic surgery, cosmetic surgery, ENT surgery, etc. It is an adjunctive hemostatic device.
Take out the applicator containing the Surgiclean® from the package, and check if it is damaged. Do not use if the sprayer or package is damaged prior to opening. Unscrew the screw cap of the sprayer, install a nozzle, and spray the Surgiclean® to the hemorrhagic sites. It’s recommended to apply according to the following steps in order to achieve better effects:
1.Absorb or wipe off excessive blood on the hemorrhagic tissues with aseptic sponge or gauze, to expose the hemorrhagic sites.
2.Immediately spray enough Surgiclean® onto the wound surfaces directly, approaching to the hemorrhagic spots to the full extent and fully covering the wound surfaces. Insert the top end of the nozzle into the deep hemorrhagic wounds or hemorrhagic sites. In this case, it’s suggested that the sprayer be continuously pressed to spray the Surgiclean® onto the wounds uninterruptedly. Note: replace new Surgiclean® if the top end of the nozzle is in contact the blood, which might result in blocking of the top end of the nozzle.
3.Apply appropriate pressure for at least one minute on the wounds directly with the gauze dressing or other equivalent articles immediately after powder spraying. Apply the pressure on the wounds with major bleeding for 2-3 minutes. It’s suggested that the excess Surgiclean® be flushed and sucked with the gauze or saline with care, and then repeat the above methods, if the bleeding or errhysis continues at the wounds.
4.Flush and suck the excess Surgiclean® at the hemorrhagic sites with saline after the hemorrhage stops.
Surgiclean® cannot replace the conventional suture when used for spurting hemorrhage.
Surgiclean® cannot replace the delicate operation procedures, rational binding and other
conventional hemostatic methods.
Surgiclean® are aseptic, and therefore cannot be re-disinfected. The unused Surgiclean® with their packages opened cannot be reused.
It’s not suggested to use Surgiclean® under the infection condition. Be careful when using the Surgiclean® at the contaminated sites. Surgical clearing of focuses of infection and adequate drainage might be necessary if the infection or abscesses happen at the sites applied with Surgiclean®.
The use of Surgiclean® combined with other hemostatics (local administration of thrombin) is not recommended since its safety and effectiveness have not been demonstrated by clinical control studies yet. Understand the characteristics of those hemostatics in details if doctors believe that local administration of thrombin or other hemostatics is necessary under that condition.
Avoid wrapping the Surgiclean®, especially in the spinal lumen, as the particle expansion might interfere with the normal function of tissues and/or result in peripheral tissue necrosis arising from compression.
Latest version 8.06.04.312-A1 Issued Date:2019-09-11