VELSEAL. THE NOVEL The Action Dressing OPEN IT. PLACE IT. TERMINATE THE BLEEDING.
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1 VELSEAL THE NOVEL The Action Dressing OPEN IT. PLACE IT. TERMINATE THE BLEEDING. Ergonomic Rectangular Design: Fits any wound shape and size, endurant & flexible No Secondary Bleeding No Exfoliation No exothermic reaction Exceptionally light weight, as easy as carrying a paper Ceases bleeding in less than 4 minutes Useful in cases of multiple injury Simple to remove Can be leftover on wound without any harm Proven highly effective in GUNSHOT WOUNDS Stops bleeding immediately in PATIENTS WITH COAGULOPATHY* Increases the safety window to securely mobilize the patient *only for Velseal-T
2 VELSEAL Velseal is a foam based dressing for control of traumatic bleeding. The ready-to-use patch consists of foam impregnated with clot promoting & stabilizing agents. These constituents are held in the vesicular voids of the matrix, on the internal surface sponge. This means they are able to act rapidly when blood flows into the dressing. Once in contact with blood, the dressing enables sealing and stabilization of wound surfaces. The Novel Features: A Novel absorbent dressing containing blood clot promoting & stabilizing agents The entire area is porous providing a high surface area for the clotting process to occur Used on external wounds to stop even severe arterial or venous bleeding within 4 minutes Severe High pressure bleeding In Hospitals and medical practices All types of accidents where excess bleeding / blood loss is a concern. In the aftermath of a catastrophe Battle fields Accidents, Trauma and emergency Prevents secondary bleeding Does not cause exothermic reactions Non cytotoxic, non irritant & non sensitiser Increases the threshold time required to mobilize the patient safely to the hospital Biocompatible and Bioabsorbable Does not stick to the wound No restriction of blood flow, improved wound hygiene Safety and efficacy established even in deep, lacerated wounds or Gunshots (Involving larger wound size or arterial damage) Accidents Happen Anywhere... Anytime...!!! Be Prepared
3 Active Constituents A Novel Polyelectrolyte complex (PEC) of biopolymers. Highly porous and impregnated with clot promoting & stabilizing agents. All constituents are held in the vesicular voids of the matrix onto the internal surface. How it Works The interconnected small voids of porous PEC sponge provides a very large surface area for the flowing blood and hold the natural clot promoting & stabilizing agents A large surface area and micro-areas exert a pseudo-catalytic effect on blood clotting The body s own whole blood coagulation cascade - is activated The blood clotting process occurs within the voids Further, the presence of impregnated naturally derived clotting factors & stabilizer intensifies the clotting action & stabilizes the clot Natural blood clotting continues to the injured blood vessel without affecting flow characteristics of circulating blood Application method VelSeal should be used externally only. Intended for use as a topical dressing for emergency use After injury, VelSeal should be placed on the wound immediately Positioned so that the blood flowing from the wound must come into contact with the matrix to initiate satisfactory blood clotting Hold the device in place upto a time period of 4 minutes Blood clotting is both within the matrix and on its surface Intended users: Medical professionals, Hospitals, Rescue and Emergency services, Chemists, Fire service, Police, Armed forces & Defence services. Schools, First aid, Workplaces, Household, Sports persons, Commercial and Personal Vehicles. INSTRUCTIONS FOR USE Step 1: Open Dressing Extract the sterile dressing from the primary packing. Step 2: Ensure that the correct side is used - Ensure that the side opposite to the marked side of VelSeal is applied on the wound, i.e. the marked side faces upwards after the application. Step 3: Apply directly on source of bleeding - It is critical to place the dressing directly on the source of the bleeding, the area where the blood vessel damage has actually occurred. Step 4: Hold firmly until bleeding is controlled - Apply firm, even pressure on the dressing for 4 minutes. Step 5: Lift and check - if bleeding has been stopped after 4 minutes, else continue pressing.
4 Trauma is one of the leading causes of morbidity and mortality. Uncontrolled haemorrhage related to traumatic event is often major cause of complications and death. 1, 2 Haemorrhage following traumatic injury accounts for 30 40% of deaths 1 Haemorrhage remains a major cause of potentially preventable deaths More than 90% of mortalities occur in low and middle income nations 3 Global road traffic injuries result in 1.2 million deaths per year, with additional million injuries 3 Violence is a large contributor to injury-related mortality as well, with 1.6 million deaths worldwide in 2000, representing 16% of mortality from injury 3 Injury represented 9% of worldwide mortality and 12% of global disease burden Out of the hospital admissions in trauma 20% develop coagulopathy. Mortality is three to four times higher in a patient with coagulopathy 4 More than 6 million deaths occur due to trauma, of which 20% are due to uncontrollable bleeding Why VELSEAL Highly Effective Can be placed directly over affected area Instant action, promotes clotting within less than 4 minutes Useful in all Trauma cases, accident, injury or casualty where bleeding is a concern VelSeal-T can also be used after angiography and angioplasty Highly Effective in GUNSHOT WOUNDS Increases the safety window to securely mobilize the patient Ergonomic Design and Packaging Fits any wound shape and size, available in different sizes. Water proof packaging, single use, sterile packs Safe Well established safety and efficacy, no known contraindications Biocompatible and Bioabsorbable No exothermic reaction Cost Effective Highly economic as compared to other products Researched, designed and developed in India Stops bleeding rapidly and may reduce the need for more expensive treatments None can predict when an accident will occur, but with VELSEAL, you ll be prepared to handle it. 1 Sauaia A, Moore FA, Moore EE, et al. Epidemiology of trauma deaths: a reassessment. J Trauma. 1995;38(2): AANA Journal, December 2013, Vol. 81, No. 6 3 Johansson et al. Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine Peden M, McGee K, Sharma G: The Injury Chart Book: a Graphical Overview of the Global Burden of Injuries. Geneva: World Health Organization; 2002.
5 Shelf Life: Velseal- 2 years Velseal-T-12 months /1 year Available sizes: Size 5 cm x 5 cm 1 piece 7 cm x 7 cm 1 piece 10 cm x 10 cm 1 piece Packaging *Dentistry pack available- (Velseal-T only) Sterilization Method: Gamma irradiation Studies Established Safety: Biocompatibility studies as per international standards. (In-vitro Cytotoxicity, Acute systemic toxicity, intracutaneous reactivity and Skin sensitization). Controlled Animal Study - Gunshot Wound Gunshot wound Hemostasis Failure with Guaze Hemostasis with VelSeal Clinical investigation - Lacerated Wound Lacerated Wound VelSeal application Hemostasis with VelSeal
6 Contraindications: No known contraindications and adverse reactions. Warnings & Precautions: For external use only The dressing should remain in position until the wound can be treated properly Do not use if pack is damaged/or contents are wet. VelSeal is supplied as a sterile, single-use dressing. Do not re-use. Do not re-sterilize If the first attempt at application of the VelSeal is not successful, do not re-apply the same dressing, instead obtain a new dressing for re-application VelSeal must be positioned properly to the bleeding wound /actual source of the bleed. Use promptly after opening. Don t keep open for long time as it may absorb moisture and change property/reduce efficacy. For more information write to Marketing Department Datt Mediproducts Pvt. Limited (An ISO 9001:2008 Certified Company) Admin Office: 56, Community Centre, East of Kailash, New Delhi Works: & 63-64, Roz-ka-Meo Industrial Area, Nuh, Distt. Mewat , Haryana, India sales@dattmedi.com Website: Customer Care Toll Free No.:
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