Surgispon Bleeding Stopper Sponge

Properties
• Dimensions; It is 20x20x0.7 mm.
• There are 20 pieces in a package.

SURGISPON ® Sterile hemostatic absorbable gelatin sponge made from pure pharmaceutical (lyophilized hydrolyzed collagen) gelatin foam.
Product Description: SURGISPON

(COLLAGEN IMPRESSED GELATIN SPONGE)

SURGISPON - Absorbable Hemostatic Gelatin Sponge is a sterile, water-insoluble, gelatin absorbable sponge intended for hemostatic use by application to a bleeding surface. SURGISPON is non-pyrogenic and biocompatible.

SURGISPON is a surgical hemostatic sponge made of premium grade gelatin material for use in a variety of surgical procedures. When administered in vivo and used in appropriate amounts, it is completely absorbed within 3 - 4 weeks. It dissolves in 2 to 5 days when applied to bleeding mucosal areas.

SURGISPON Gelatin Sponges have a porous structure that activates platelets when blood comes into contact with the matrix of the sponge. This allows platelets to release a number of substances that promote their aggregation as their surface changes, thereby acting as a catalyst for fibrin formation.

INDICATIONS:

SURGISPON has been used effectively in various surgical fields for hemostasis when capillary, venous and arteriolar bleeding is controlled by ineffective or unfavorable pressure, ligature and other customary procedures.

CONTRAINDICATIONS:

Situations in which SURGISPON should not be used:

• Closure of skin incisions that may conflict with the healing of skin edges

• Patients known to be allergic to collagen

• Intravascular parts due to embolization risk

• With metal methacrylate adhesives

• With autologous blood recovery circuits

• For primary treatment of coagulation diseases

• In case of infection

• For control of post partum bleeding or menorrhagia

• In cases such as arterial bleeding pumping

• Where blood or other fluids have accumulated or where the bleeding point has become sunken

   cases

• SURGISPON Sponge will not act as a tampon or plug at a bleeding site and
also, a tampon will not cover an area of ​​accumulation in front of it.

SURGISPON has proven safety and validity in the following areas:

• To be used in eye-related procedures,

• In children and pregnant women,

Otherwise, it is removed again and rubbed vigorously until all air is removed, and when reverted to sterile saline it expands to its original size with slight increases in thickness and shape. SURGISPON, if used wet, leaves a moist stain on the gauze before applying to the bleeding site. It should be held in place by applying moderate pressure using a cotton thread or small gauze sponge until hemostasis occurs. To prevent withdrawal of SURGISPON by enclosing a dense clot, withdrawal of a tampon or gauze is made easier by moistening it with a few drops of sterile saline. It is unnecessary to use suction applied to draw blood from the cotton or gauze tampon to the SURGISPON, as SURGISPON will generate sufficient blood by capillary action.
The initial administration of SURGISPON is usually to control bleeding, if not, additional administrations can be made. For additional applications, new materials should be used as prepared as described above. Use only the minimum amount of SURGISPON to achieve hemostasis. After hemostasis has been achieved, any excess Gelatin Sponge should be carefully removed due to the possibility of device displacement or compression of other nearby anatomical structures.
When placed in cavities or closed tissue areas, minimal primary compression is recommended. Overpackaging of SURGISPON should be avoided; because once its initial volume is reached it may impair normal functions and/or cause possible or eventual compression necrosis, damage to surrounding tissue and nerves. Sometimes, if lining of a cavity for hemostasis has been indicated surgically, a gelatin sponge should not be used in this manner unless there is an excess of product to remove hemostasis. SURGISPON should be withdrawn after use and cessation of bleeding in radical cavities, laminectomy procedures, around or proximity of the foramen in bone, areas in bony areas, spinal cord and/or optic nerve and closed tissue spaces with the presence of muscle or bone. This may result in unwanted pressure on adjacent structures that may cause pain for the patient, or possibly lead to nerve damage.

Since SURGISPON causes much more cellular reaction than a blood clot, it can cover the wound. When SURGISPON is applied to mucous surfaces, it should be withdrawn before liquefying.
SURGISPON is not intended to replace rigorous surgical techniques and for proper ligature application for hemostasis or other ordinary procedures.
SURGISPON should not be used for the primary treatment of coagulation disorders.
SURGISPON should be used with caution on contaminated areas of the body.
If signs of infection or abscess develop where the SURGISPON Sponge was inserted, repeat surgery may be required to remove infected material and allow drainage.
Users must be familiar with gelatin sponges and surgical procedures and techniques before using SURGISPON.
The specific factors of each patient should be addressed in accordance with their in vivo healing process. Contaminated or infected wounds should be handled with appropriate surgical procedures.

SURGISPON sterile sponge is packaged in sterile blests that guarantee sterility. Once the package is opened, its contents become contaminated. When the package is opened, it is recommended to use SURGISPON immediately and dispose of any unused content as soon as possible. It should not be reused or resterilized as it will lose its sterility as well as its physical properties. Gently open the blister pack by pulling the two loose ends apart so that SURGISPON can be removed undamaged onto a sterile surface.
The product is for single use only!
Destroy remaining, unused SURGISPONs. Dispose of contaminated devices and packaging materials in accordance with standard patient procedures and universal rules for the prevention of biohazardous waste.
STERILIZATION:
SURGISPON has been sterilized by gamma irradiation. Do not resterilize! Do not use if the package has been opened or damaged. This device has been designed, tested, and manufactured for a single patient only. Reuse, use of the device in opened or damaged packaging, reprocessing and/or resterilization of the device may result in device failure and subsequent patient injury, illness or death and/or risk of contamination and patient infection, patient illness or death.
STORAGE:
The product should not be exposed to direct sunlight and heat and should be stored in its original packaging in a clean and dry room at a room temperature between 5°C and 30°C.
Do not use after the expiry date!

PACKAGING:
Available in various shapes and sizes suitable for different surgical procedures.