SIDA-CEL™ Hemostatic Gauze Pads.

Sterile hemostatic gauze for control of traumatic bleeding.
This hemostatic gauze contains a unique Sodium Carboxymethyl Cellulose material (CMC) derived from Regenerated Cellulose.
Quickly absorbs water contents of exudates
Forms gelatinous mass and fills wound void
Seals capillary ends and stops bleeding fast and effectively
For external bleeding control of superficial wounds, minor cuts, and abrasions
Made in Greece; CE approved.

INSTRUCTIONS OF USE

ACTION MECHANISM
When SIDA-CEL Soluble Hemostatic Gauze comes in contact with the bleeding site, it can quickly absorb water contents of exudates to form gelatinous mass, which fills wound voids, seals capillary ends, and thereby helps to stop bleeding.

INTENDED USE
SIDA-CEL Soluble Hemostatic Gauze can be used in the control of disseminated hemorrhage, capillary and small vessels hemorrhage when ligation, electrical coagulation or other conventional methods are impractical or ineffective. It is indicated to control the vaginal and cervical hemorrhage, nasal and sinus mucosal bleeding, dental surgery bleeding [tooth extraction, dental implantology surgery, parodontology surgery (dental and gum surgery)] and topical bleeding of injured body surface.
CONTRAINDICATIONS
SIDA-CEL Soluble Hemostatic Gauze should not be used for large areas of wound hemostasis and hemorrhage of large arteries.
PRECAUTIONS
- The package should be checked before use. The product cannot be used if the package is torn or damaged.
- After package is opened, the product should be kept as dry as possible. Hemostatic effect will be affected if the product is moistened. Before use, the product should not be moistened by water or saline. Gloves and devices should be kept dry before use.
- The blood vessel should be ligated if there is pulsing vessel at hemorrhage site.
- The product should be avoided to be flushed or immerged by water during hemostasis; operation can continue after effective hemostasis.
- When applied to ENT or Department of Gynaecology and Obstetrics, the pressure at the filling site should not be too great, because it may cause swelling, ischemia or necrosis of local tissues.
- When applied to ENT Department, measures should be adopted to prevent patients from absorbing the product into respiratory duct.
- When applied in cavities or tracts, the formed gelatinous mass and any other remnant of the product should be thoroughly removed, once hemostasis is achieved.
- Patients with hypertensive constitution should use the product with caution, and patients hypersensitive to the product cannot use the product.
- It is a disposable product, and cannot be reused.
ADVERSE REACTIONS
No reports on adverse reaction have been issued.
DOSAGE AND ADMINISTRATION
Pick out SIDA-CEL Soluble Hemostatic Gauze from the package under sterile conditions.
When applied to body surface, the product should be tailored according to the wound area, and apply slight direct pressure until hemorrhage is stopped.
When applied to deep wound in nasal cavity, sinus or vagina, the product should either be rolled in order to fill the hemorrhage site or it should cover the hemorrhage site directly to obtain better hemostatic effect.
The dose can be adjusted based on hemorrhage amount and nature. If the hemorrhage amount is large, multiple layers can be applied to press the wound and stop hemorrhage.
When hemostasis has been achieved, remove the saturated gauze using sterile water or saline solution and gently wiping away from the wound any excess material.
DENTAL INSTRUCTIONS
1. After tooth extraction, debride the socket with copious sterile water.
2. Insert one or more pieces of SIDA-CEL Soluble Hemostatic Gauze pad to the socket place with dry forceps.
3. Place slightly moistened regular gauze sponge over the socket and instruct the patient to bite with gentle pressure.
4. Rinse away with sterile water or saline solution once the bleeding has stopped.
Repeat the steps above with another piece of SIDA-CEL Gauze as needed.
If allergy occurs, contact a Doctor of Emergency Room.Do not use to treat a dry socket.
STORAGE
It should be stored in a dry and ventilated place, with no active gases, under 5 - 45 oC.
PACKAGING
Independent sterile packaging into foil bags.
SHELF LIFE
Three years.

The SIDA-CEL Gauze, is a single use, sterile and bio absorbable medical device, made from regenerated cellulose, which can be fabricated into a variety of forms to suit a variety of wounds in the control of bleeding. It is a water soluble gauze, based on cellulosic structure. It is intended for external bleeding control of superficial wounds, minor cuts, and abrasions - great for home/personal use. Upon application and contact with blood, the product’s molecular structure changes to form a gelatinous membrane, which adheres to the wound creating a mechanical barrier to immediately reduce blood flow. The product’s unique gel utilizes the hydration forces between the mucosal layer and itself which results in a strong physical attraction that leads to the adherence of the product to the tissue. The stronger the bleeding pressures in the wound, the stronger the attraction. Next, platelets from the injury attach to the gauze by inter-molecular forces to form a stable membrane on the wound site, which is able to withstand severe arterial and venous blood flow for hours. This dramatically reduces the flow of blood from the wound. After bleeding has stopped, the remaining residual membrane can be irrigated out of the wound safely without pulling on soft tissue or the existing clot.

Acts as a stabilizing, thickening and suspending agent.
Quickly absorbs water contents of exudates.
Forms gelatinous mass.
Fills wound void.
Seals capillary ends.
Stops bleeding fast and effectively.
Clinically proven reduced blood coagulation time.
Neutral pH 7.0, hence no burning sensation.
Sterilized by Gamma Radiation.
Bacteriostatic properties.
Biocompatible.
Non-irritating.
Latex Free.

PRODUCT SPECIFICATION

Ref. No.: 18000, 18001, 18002, 18003, 18004, 18005, 18006, 18007, 18008, 18009, 18010, 18011

Intended Use: For the control of disseminated hemorrhage, capillary and small vessels hemorrhage when ligation, electrical coagulation or other conventional methods are impractical or ineffective. It is indicated for vaginal and cervical hemorrhage, nasal and sinus mucosal bleeding, and topical bleeding of injured body surface and for dental use.
Certification: CE0653
Classification: Class ΙIa, according to Annex IX of Council Directive 93/42/EEC
Sterilization Method: Irradiation
Conformity: MEDDEV 2.4/1 Rev. 9 - June 2010 Rules 4 & 5
Shelf life: 3 years
Applicable Standard: ΙSΟ 9001, ΙSΟ 13485, ΙSΟ 14971, ΙSΟ 11607, ΙSΟ 10993, ISO 11137, ISO 14155, ISO 15223, ISO 13726, ISO 14079

Packing: Aluminum foil & Paper/film pouch