Surgiclean® / Quickclean® Absorbable Hemostatic Particles
CE 2460
[Composition]:
100% Potato Starch
[Specifications]:
0.5g/Piece,1.0g/Piece,2.0g/Piece,3.0g/Piece, 5.0g/Piece
[Description]:
Surgiclean MPH Absorbable Hemostatic Particles (Hereafter called Surgiclean) is spherical or ellipsoidal microporous microspheres with spatial reticular microstructure, good biocompatibility, prepared with potato starch as the raw materials using the emulsification and crosslinking technology, it is aseptic and pyrogen-free, and contain no components of animal origin or human origin.
【Mode of Action】:
Surgiclean has the function of a hydrophilic molecular sieve, can absorb and lockthe water several times over weighting itself instantly to form a gel, and form gelmixtures around particles by condensing visible components in the blood outsidethe gel, such as platelets, red blood cells, albumins, thrombin and fibrinogen, thuspromoting instant clot forming; in addition, the blood at the bleeding sites isconcentrated rapidly, thus resulting in concentration of platelets, initiating thecoagulation mechanism, and accelerating the natural coagulation; Surgiclearapplies certain pressure on the peripheral vessel to promote the hemostasis afterabsorbing water and expanding; Surgiclean forms waterproof gels afterabsorbing water, and the polysaccharide particles can block off the wounds andpromote the blood coagulation. Surgiclean hemostatic microsphere degrades in the bodies initiates after hemostasis and finishes within 14 days. The Surgiclean is decomposed into maltose and glucose by amylase and α-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 indicated in surgical procedures(except neurological and ophthalmic)as an adjunctive hemostatic device to assist when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
[intended Patient Population]:
The product should be used by professional surgeons for patients who need adjunctive hemostatic device during surgery, However, the product is not recommended for children, pregnant woman and people allergic to starch.
[Usage]:
For open surgical procedures:
Take out the spray bottle containing the Surgiclean from the package, and check if it is damaged. Do not use if the spray bottle or package is damaged prior to opening. Unscrew the screw cap of the spray bottle, install a nozzle, and spraythe 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 should 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 minutesIt's suggested that the excess Surgiclean should be flushed and sucked with thegauze or saline with care, and then repeat the above methods, if the bleeding orerrhysis continues at the wounds.
4. Flush and suck the excess Surgiclean at the hemorrhagic sites with saline afterthe hemorrhage stops.
In endoscopic/laparoscopic/ minimally invasive surgery, Surgiclean requires connecting a longer applicator for use, please follow the instructions for use for the given applicator in order to appropriately apply Surgiclean onto the woundsite. The applicators contain:
MPH Absorbable Hemostatic Particles Applicator, model: TQ-1, TQ-2 and TQ-4
Forendoscopic/laparoscopic surgical procedures:
Follow all steps above for open surgical procedures. In addition to these steps:
1. Set up the trocar prior to use. Carefully remove the applicator from the trocar after use.
2. Maintain direct visualization of the applicator tip at all times in order to minimize the potential for unintended contact with tissue, organs, or blood, which may lead to occlusion of the tip.
If the applicator becomes occluded during use, replace it with a new applicator.
[Expected clinical benefit]:
Surgiclean can block off the wounds and promote the blood coagulation, and degrade in the bodies initiates after hemostasis and finishes within 14 days.
[Contraindication]:
Surgiclean cannot replace the conventional suture when used for spurting hemorrhage.
Surgiclean cannot replace the delicate operation procedures, rational bindingand other conventional hemostatic methods. Surgiclean is aseptic, and therefore cannot be re-sterilized. The unused Surgiclean with their packages opened cannot be reused. Reuse of Surgiclean may lead to patient infection and/or hemostasis failure.
Do not inject or place Surgiclean into blood vessels as potential for embolization and death may exist.
Surgiclean is not recommended for use with autologous blood salvage circuits, because there may be a risk of some small particles entering into blood and causing embolism.
[Warning]:
Surgiclean should be used by professional surgeons for patients who need adjunctive hemostatic device during surgery. 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, as the particle expansion might interfere with the normal function of tissues and/or result in peripheral tissue necrosis arising from compression.
Once hemostasis is achieved, excess Surgiclean should be removed from the site of application by irrigation and aspiration. Safety and effectiveness in neurosurgical and ophthalmic procedures have not been established. Surgiclean is not recommended as the main treatment for patients with coagulation disorders. When used in urology, Surgiclean should not be left in the pelvis or ureter to prevent the risk of stone formation. Surgiclean has not been studied on bone surfaces. Safety and effectiveness of Surgiclean have not been clinically evaluated in children and pregnant women. Surgiclean is not suitable for people allergic to potato starch.
[Precautions]:
1. This product is aseptic and pyrogen-free, and shall be subject to aseptic operation and for single use.
2. Do not use in case of damaged packages.
3. The used or overdue Surgiclean should be discarded and disposed as medical waste.
4. The package contains a pre-printed implant card and a leaflet for the implant carddo not forget to complete it and give it to the patient.
5. In case of any serious incident related to the device, it shall be reported to manufacturer/distributor, EU authorised representative and competent authority of the Member State in which the user and/or patient is established.
6. Care should be taken to dispense the product in a manner to avoid inhaling material and to wear proper protective barrier, like a mask.
7. The device is intended to be used in a dry state. Contact with saline oiarilibiolic solutions prior to achieving hemostasis will result in loss of hemostatic potential.
[Adverse Reaction]:
No reported so far. However, there are potential adverse events that Surgiclean may cause, include pain related to surgery, nausea, inadequate hemostasis, infection, erythema, adhesions, hematoma, abscess, diarrhea, swelling, pleural effusion. respiratory reaction, delayed wound healing, fistula, chemicaperitonitis, inflammation, fever, obstruction, discomfort, low biood pressurevomit, rash and skin irritation, according to the report of similar hemostasis product.
[Shelf Life]:
3 years.
[How Supplied]:
Surgiclean is packaged in polyethylene sprayers sealed by screw capsconditioned in a blister of Pvc, sterilized with ethylene oxide and then sealed inaluminum foil bag, and finally packaged into carton box with an instructions foruse, an implant card and a leaflet for implant card.
[Dosage]:
Maximum dosage shall not exceed 5g per person each time. Overdose may cause granulomas and foreign body reactions.
[Storage]:
This product should be stored between 5℃ and 25℃.
Latest version 8.06.04.0318 A2 Issued Date:2025-01-02
