PAHACEL Pillow is a structured non-woven fabric, needle punched with interlocking fibers for extra hemostasis. Provides a matrix for platelet adhesion and aggregation.Proven highly effective bactericidal effect.

PAHACEL OXIDISED REGENERATED CELLULOSE INSTRUCTION FOR USE
Standard Type Absorbable Hemostat Loose knit of ORC
Knit Type Absorbable Hamostat Densely woven knit of ORC
Fibril Type Absorbable Hamostat Soft, lightweight, layered ORC
Pillow Type Absorbable Hemostat Structured non-woven fabric, needle punched with interlocking fibers
Description:
Pahacel Absorbable Hemostats are sterile absorbable knitted fabrics prepared by the Controlled oxidation of Regenerated cellulose. The fabric is white with pale yellow cast and has a faint, caramel like aroma, it is strong and can besutured or cut without fraying. A slight discoloration may occur with age but this does not affect performance. The Pahacal Fibril form of product allows the surgeon to grasp with forceps any amount of Pahacel Fibril Hemostat needed to achieve hemostasis at a particular bleeding site. The Pahacel Fibril and Knit
form may be more convenient than the knitted form for hard to reach orirregularly shaped bleeding sites.
Intended Use
Pahacel Absorbable Hemostat (Oxidised Regenerated Cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous and small arterial hemorrage when ligation or other conventional methods of control are impractical or ineffective. Pahacel Standard, Pahacel Fibril,Pahacel Knit, Pahacel Pilow type hemostats can be cut to size for use in
endoscopic procedures.
Pahacel Absorbable Hemostat (Oxidised Regenerated Cellulose is absorbed in the body within 7-14 days
Hemostatic Effects: Serves as a hemostatic adjunct.
Contraindications:
Although packing or wadding sometimes is medically necessary, Pahacel Absorbable Hemostat should not be used in this manner, unless is to be removed after hemostasis is achieved. Pahacel Absorbable Hemostat should not be used for implantation in bone defects, such as fractures, since there is a possibility of interference with callus formation and a theoretical change of cyst formation When Pahacel Absorbable Hemostat is used to help achieve hemostasis in around or in proximity to foramina in bone, areas of bony confine, the spinal cord or the optic nerve and chiasm, it must always be removed after hemostasis is achieved since it will swell and could exert unwanted pressure.
Pahacel Absorbable Hemostat should not be used to control hemorrhage from large arteries. Pahacel Absorbable Hemostat should not be used on non-hemorrhagic serous oozing surfaces, since body fluid other than whole blood, such as serum, do not react with Pahacel Absorbable Hemostat to produce satisfactory hemostatic effect. Pahacel Absorbable Hamostat is anabsorbable Hemostat and should not be used as an adhesion prevention product.

Warnings: Pahacel® Absorbable Hemostat is not intended as a substitute for careful surgery and the proper use of sutures and ligatures. Closing Pahacel® Absorbable Hemostat in a contaminated wound without drainage may lead to complications and should be avoided.

The hemostatic e‹ect of Pahacel® Absorbable Hemostat is greater when it is applied dry; therefore it should not be moistened with water or saline. Pahacel® Absorbable Hemostat should not be impregnated with anti-infective agents or with other materials such as bu‹ering or hemostatic substances. Its hemostatic e‹ect is not enhanced by the addition of thrombin, the activity of which destroyed by the low pH of the product. Although Pahacel® Absorbable Hemostat may be left in situ when necessary, it is advisable to remove it once hemostasis is achieved. It must always be removed from the site of application, when used in, around or in proximity to foramina, in bone, areas of bony conne, the spinal cord, and/or the optic nevre and chiasm regardless of the type of surgical Procedure because Pahacel® Absorbable Hemostat, by swelling, may exert pressure resulting in paralysis and/or nevre damage. Dislodgement of Pahacel® Absorbable Hemostat could possible occur by means such as repacking, further intraoperative manipulation, lavage, exaggerated respiration, etc. The Pahacel® Absorbable Hemostat, when left in the patient after closure, may migrate from the site of application into foramina in bone around the spinal cord resulting in paralysis and may cause the left orbit of the eye, cause blindness.

Special care must be Taken by the surgeons/physicians, regardless of the type of surgical procedure, to consider the advisability of removing Pahacel® Absorbable Hemostat after hemostasis is achieved.

Although Pahacel® Absorbable Hemostat is bactericidal against a wide range of pathogenic microorganisms, it is not intended as a substitute for systemically administered therapeutic or prophylactic antimicrobial agents to control or prevent post-operative infections.

During insertion even should be used as a thin film on the tissue, the product should not folded. The product should not folded on application area.

EXCESS AMOUNT OF OXIDISED REGENERATED CELLULOSE SHOULD BE REMOVED AFTER ACHIEVING HEMOSTASIS.

An eventual excess of Pahacel® ORC as a ller during surgeries may cause foreign body reactions. Although Oxidised Regenerated cellulose products are not appropriate for arteriolar bleeding encountered during surgery, they could help in a quick hemostasis of moderate venous and capillary ooze frequently associated with the excision of intrinsic tumors, lobectomies, or intracerebral hemorrhages. Product is frequently used to stop oozing from the epidural space and to decrease epidural hematoma formation during intracranial surgery (via application to the interface between themdura and the margins of the craniotomy defect).
It is known that any kind of ORC has a tendency to swall once placed, increasing the risk of its use in closed or bone walled spaces. There have been several cases of post thoracotomy paraplegia owing to the compressive effects of ORC in adults and children undergoing thoracotomy for pulmonary esophageal pathologies and
resection of mediastinal neuroblastoma, They speculated that pressure differences on closure of the thoracic cavity caused ORC to migrate into the spinal canal through the foramen.
Closure of the thoracotomy with rib approximation could produce a compressive force on the ORC forcing into the tracheal and esophageal lumen.
An excess of ORC may complicate some surgeries as thoracotomy by migrating
through the suture lines into the organs with lumen or foramen.
Therefore, Phacel ORC should be used judiciously and avoiding the use of an excessof product
Precautions:
Use only as much Pahacal" Absorbable Hamostat is necessary for hemostasis, holding it firmly in place until bleeding stops. Remove any excess before surgical closure in order to facilitate absorption and minimize the possibility of foreign body action.
In Urological procedures, minimal amounts of Pahacel Absorbable Hemostat should be used and care must be exercised to prevent plugging of urethra, ureter, or a catheter by dislodged portions of the product
Since absorption of Pahacal" Absorbable Hemostat could be prevented in chemically cauterized areas, its use should not be preceded by application of silver nitrate or any other escharotic chemical.
If Oxidised Regenerated Cellulose is inserted on peritoneum to avoid bleeding or in a part where is no bleeding contact, than the absorption could take a bit more time.
During insertion even should be used as a thin film on the tissue, the product should not folded.
Laparoscopic total/partial hysterectomies severe endometriosis, radical hysterectomies and myomectomy cases as well as Borderline ovarian tumor surgeries, absorption could take a bit more time and the product should not folded on application area.
If Pahacel  Absorbable Hamostat is used temporarily to line the cavity of large open wounds, it should be placed so as not to overlap the skin edges. It should also be removed from open wounds by forceps or by irrigation with sterile water or saline solution after bleeding has stopped.
Precautions should be Taken in otorhinolaryngologic surgery to assure that none of the material is aspired by the patient (controlling hemorrage after tonsillectomy and controlling epistaxis).
Care should be Taken not to apply Pahacal" Absorbable Hemostat too tightly when it is used as a Wrap during vascular surgery.
Endoscopic procedures should be performed only by persons having adequate
training and familiarity with endoscopic techniques. Consult medical literature relative to techniques, complications and hazards prior to performance of any endoscopic procedures.

Sterility:
The Pahacel Hemostats are sterilized by Gamma irradation technique.
Pahacel Hemostats for single use only; do not resterilize! Use an aseptic technique inall phases of handling. Altaylar Medical Ltd. will not be responsible for any product that is resterilized, nor will we accept for credit or Exchange any product that has been opened but not used. If you received this product in a sealed pouch package, it will remain starle until the expiration date printed on the Package label or until the package is opened, whichever occurs first. If you received this product in an unsealed pouch paper package And/or as part of a custom procedure pack, the sterilization is(or Will be) the responsibility of the pack distributor.

Warranty:
Manufacturer warrants that this medical device is free from defects in both materials and workmanship. The above warranties are in lieu of all other warranties, either express or implied, including any warranty of merchantability or fitness for a particular purpose.Suitability for use of this medical device for any surgical procedure shall be determined by the user Altaylar Medikal shall not be liable for incidental or consequential damages of any kind.