maQuira 0403071 Hemospon Gelatin Hemostatic Sponge Instructions
- June 13, 2024
- maquira
Table of Contents
maQuira 0403071 Hemospon Gelatin Hemostatic Sponge Instructions
Read carefully al the information in this instructions before using the product, Store it for at least a full consultation of the product andor until there Is no further intaraction of the product with your last patient.
PRESENTATION
HemosponⓇ 1,0 x 1,0 x 1,0 cm – Package containing 10 or 40 units.
HemosponⓇ COTE 2,0 x 4,0 cm – Package containing 1 unit.
Hemospon® TAPE 2,5 x 7,5 cm – Package containing 1 unit.
Hemospon® STANDARD 70 x 50 x 10 mm – Package containing 1 unit.
HemosponⓇ STANDARD 80 x 50 x 10 mm-Package containing 1 unit.
HemosponⓇ SIZE 125 x 80 x 10 mm – Package containing 1 unit.
DESCRIPTION
Hemospon® is a lyophilized gelatin hemostatic sponge. Hemospon® has a healing hemostatic action and is completely absorbable by the body in approximately 2 to 8 weeks. HemosponⓇ is non-toxic and pyrogen-free. Ready for use. It is packed in individual blisters. The product is presented sterile, being sterilized by gamma radiation.
INDICATION OF USE
Hemospon is indicated during and after surgical procedures to obtain local hemostasis, especially when bleeding control by conventional methods is ineffective. In dental surgical procedures, Hemospon®, besides providing hemostasis, also has the following purposes: HemosponⓇ 1,0 x 1,0 x 1,0 cm: acts in the clot maintenance in the surgical region and in filling the spaces generated in conventional dental extractions, removal of included or impacted teeth, removal of cysts and tumors, biopsies, etc. Hemospon® COTE e Hemospon® TAPE: protection of wounds produced during dental procedures, such as periodontal surgeries, closure of graft donor areas (palatal donors), stabilization of particulate bone grafts and in maxillary sinus surgeries (Schneider membrane lifting/repair). In medical surgical procedures: Hemospon® STANDARD 70, STANDARD 80 e SIZE: product indicated for hospital use or specialized outpatient use. It aims to obtain local hemostasis and help to heal in surgical procedures in general, such as removal of cysts and tumors, biopsies, among others.
OPERATING MECHANISM
HemosponⓇ shall be applied as an absorbable hemostatic, to reduce bleeding and stabilize the blood clot. Its porous structure provides the product with a great fluid absorption capacity, absorbing 40 to 50 times its weight. The blood clot is formed due to blood platelet clumping at the bleeding site, and the resulting activation of the clotting factor cascade. Hemospon® provides a matrix allowing further strengthening of the blood clot formed. Besides this local effect, the product has no other pharmacodynamics effects.
COMPOSITION
Gelation of porcine origin.
MODE OF USE
- Handle HemosponⓇ using aseptic technique. Be careful when removing the sterile product from the packaging, avoiding contaminating it.
- If necessary, the product can be cut to the desired size.
- HemosponⓇ can be applied dry to the bleeding surface or moistened with sterile saline.
- Apply HemosponⓇ directly to the area where hemostasis is required. It can be applied simply or with a slight compression.
- Keep the product in place until hemostasis is reached (on average 10 to 15 seconds). The time required for hemostasis may vary according to the bleeding intensity.
- If a product application is not enough, an additional application should be made using new product units.
- Once hemostasis has been achieved, Hemospon® can be removed, replaced, or left in place until completely absorbed, which occurs within up to 8 weeks.
- If applicable, suture the surgical wound.
Protect small areas from oral surgery:
Once hemostasis is achieved, HemosponⓇ tapes should be left in place,
otherwise the bleeding may occur again. When applicable, suture the surgical
wound while holding the Hemospon® tape.
Stabilization (containment and protection) of particulate material for bone
grafting:
After filling the surgical region with particulate bone (bone grafting),
carefully fit the HemosponⓇ tape over the operated area. Suture the surgical
wound while holding the HemosponⓇ tape.
Lifting/repair of Schneider membrane (maxillary sinus lining membrane):
After exposing the maxillary sinus, protect and/or seal the Schneider membrane
with the HemosponⓇ tape, gently fitting it to the external surface. If
necessary, fill the surgical region with particulate bone (bone grafting)
without leaking it into the Schneider membrane. Promote the stabilization
(containment and protection) of the bone graft with a bioabsorbable membrane.
Suture the surgical wound.
CONTRAINDICATIONS
HemosponⓇ should not be used in the following situations: Patients with hypersensitivity to product components. Events of coagulation disorders. Infected or contaminated areas, unless used with antibiotics. HemosponⓇ should be used with care in contaminated areas of the body.
Heavy bleeding and in case of blood stasis or stagnation of other organic fluids, where the source of bleeding is completely occluded. Closing skin incisions, as it may interfere with the healing of the skin edges. This is due to the mechanical interposition of gelatin and not due to the intrinsic interference in wound healing. In association with methylmethacrylate bone cement, as the porous structure of the collagen weakens the cement resistance used to fix the prostheses on the bone surface.
ADVERSE EFFECTS
There are no reports of adverse effects for the product used correctly for its purpose and according to the instructions for use. Moreover, it is known that the following side events may occur: allergic reactions, foreign body reaction, fluid encapsulation, hematoma formation and compression with damage to local tissues.
WARNINGS AND PRECAUTIONS
Professional use only. The product is manufactured for use only as stated in the instructions for use. Separate use is the sole and exclusive responsibility of the professional who uses it. Before use, inspect the packaging and the integrity of the sterile barrier. Do not use if the package is open or broken. Once the packaging is opened, the contents are subject to contamination. Hemospon® is recommended for use as soon as the packaging is opened, and the unused content should be discarded. Remove the product from the sterile packaging using an aseptic technique. If the product is contaminated, It should be discarded immediately. Adherence is important to the principles of aseptic technique when handling and using this product. HemosponⓇ shall be handled with sterile tweezers or scissors. Use HemosponⓇ in minimal amounts to achieve hemostasis and always remove any excess product from the application site to avoid the risk of product displacement or expansion and possible compression of adjacent structures. HemosponⓇ should not be used where blood or other fluids have collected, or in cases where the bleeding point is submerged, as it can mask an underlying source of bleeding, resulting in a hematoma. The use of HemosponⓇ is not recommended in the presence of infection, at risk of increased infection. HemosponⓇ should be used with caution in contaminated areas of the body. If signs of infection or abscess appear where the product has been placed, further surgery may be necessary to remove the infected material and allow drainage. Do not use the product in case of heavy arterial or venous bleeding. Combining HemosponⓇ with pharmacologically active substances or other substances should be carefully considered by the surgeon and, in any case, will be entirely his responsibility. The use of HemosponⓇ with other agents, such as topical thrombin, has not been evaluated in controlled clinical trials. If at the surgeon’s discretion, the simultaneous use of topical thrombin is clinically recommended, the product literature for that agent should be consulted for complete prescription information. When used correctly and in the proper amount, HemosponⓇ is reabsorbed within 2 to 8 weeks. The amount of product to be used and its resorption will depend on the extent of the bleeding surface and the hype of tissue on which it is applied. The use of HemosponⓇ is not intended to replace the meticulous surgical technique and the proper application of bandages or other conventional procedures for hemostasis. The safety and efficiency of Hemospon® in children and pregnant women have not been verified. In case of allergic reactions, discontinue use immediately. If necessary, seek medical advice. Do not use the product if it is after the expiration date. Keep out of reach of children. Single-use product. Sterile product. Do not reprocess or resterilize.
STORAGE CONDITIONS
Always store the product in a clean, dry place, in its original closed package, keeping the protective outer packaging at a temperature between 15 °C to 30 °C. Protect from direct sunlight. DISPOSAL MODE: Do not reuse the product and dispose of it in accordance with local legislation, ensuring its complete decharacterization to prevent its reuse and environmental damage.
VALIDITY
If properly packaged, the product is valid for 2 years from the date of manufacture. The expiry date on the packaging represents the maximum period for use of the product. Do not use after expiration date.
Symbology
Manufacturer
Consult instructions for use.
Batch Code.
Catalogue number.
Caution
important preventive information
Use-by date.
Temperature limit.
Keep dry.
Keep away from sunlight.
Do not re-use.
Sterilized using irradiation.
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