可溶性止血膜
Soluble and Hemostats Mcmbrane

医用可溶性止血膜使用说明书


   [产品名称]可溶性止血膜

   [英文名称]Soluble and Hemostats Mcmbrane

   [结构模式](KRX-02

一、名称:医用可溶性止血膜
  分子结构:


二、原理
  产品采用自然植物纤维为基础原料,经梳理、精纺、脱脂制成天然植物纤维素织品,再经理化处理,获得了一种遇血液后1min内即开始膨化、凝胶化的新型止血材料,当产品在水分子结合前,可溶性止血膜仍保持纺织材料的物理形态。
  本产品的特点:用于出血性创面止血见效迅速,对人体无毒无害无刺激。

三、止血机理
  1、本医用可溶性止血膜接触人体创面后,首先作为外凝血因子的形式,刺激人体Ⅱ
    凝血酶原,产生凝血因子,起到止血的作用。
  2、遇血膨化的凝胶状物质,为大分子结构,能够和血液中纤维蛋白网织成一层高粘
    滞度的止血层,以促进止血功能。
  3、可溶性止血膜在遇血融化的同时,对创面血液中血小板起到集附效应,使创面局
    部在止血膜凝胶物质的作用下,血小板大量集附创面,加速止血作用。
  4、止血膜在创面膨化时能吸收血液中的水份,浓缩了血液和凝胶的止血膜更有利于
创面的止血效果。

四、适应范围
  1、产品能广泛地适用各级医疗卫生机构,常见的外科、伤骨科、妇科、五官科、口腔科、肛肠科、烧灼科等病房,门急诊部
    门,对出血性创面的止血作用十分显著。
  2、在工矿企业、农村企业的意外突发事故,抗震救灾现场、军警部队平、战时的列兵救护装备中,均可以采用可溶性止血膜,
    发挥其快速有效的止血功能,以尽最大可能地挽救失血伤患人员的生命。
  3、居家生活、旅游探险、体育运动等意外损伤的出血性创面。

五、使用禁忌
  1、创面有污染或严重感染的时、创面外有异物,脓液渗出物引流不畅时,不能使
    用本止血膜。
  2、当遇到中、大动脉损伤的创面出血时,首先必须在向心性端压迫止血以后,才
    可在出血创面上使用本产品。
  30102型可溶性止血膜仅供体表创伤面止血用,体腔内出血创面可选用03型系
    列产品。

六、使用方法
  1、将损伤的出血性创面作清创消毒处理,然后根据创面面积和出血量的多少,选取止血膜的大小和层数,直接贴敷于止血创口
    上,再用医用纱布,绷带包扎固定。
  2、中、大动脉损伤的创面出血时,首先必须在向心性端压迫止血以后,才可在出血创面上使用本产品,如遇贯穿伤口可将止血
    膜卷成圆柱状,填塞伤口有良好效果,溶解后的凝胶可被人体完全吸收。
  3、感染性的创面,在使用产品止血的同时,必须采用有效的抗菌或抗破伤风血清治疗。

七、储存要求
  1、产品储存时必须防潮,避免高热烘烤,储存室应保持干燥通风,室温在-50℃~60℃
  2、产品有效期为2年。
  3、小包装袋如果破损,作报废处理,严禁使用。
 

Soluble and Hemostatic Membrane for Medical Use Instruction
Ⅰ. Name:Soluble and Hemostatic Membrane for Medical Use
  Molecular Structure:

Ⅱ. Action
  This soluble and hemostatic membrane is new type of gelatinized hemostatic material made of natural plant cellulose texlure by using natural plant fiber as the basal raw material through carding ,worsting and degreasing processing followed by chemophysical treatment enabling the membrane to bulk within one minute of contacting blood .It maintains the physical morphology of a fabric textile before combining with water molecules .This product is characterized by quick action ,atoxicity to the human body no adverse rection or imitation.   

Ⅲ.Mechanism of Hemostasis
  
1. When contacing the human hemorrhagic wound surfacd, the membrane first
   serves as an extinsic coagulation factor to stimulate human thrombogen Ⅱto
   prouce.
  2. The gelatinized material that bulks on contacting blood is of macromolecular
   structure,able to reticulate a hemostatic layer of high viscosity in combination
   with fibrin in the blood to effect hemostasis further.
  3. When the membrane contacts blood,it melts and at the same time offers an
   aggregation effect on the platelets in the wound blood. As a result, the platelets aggregate on the wound surface,
   accelerating local hemostasis under the action of the membrane.
  4. The membrane absorbs water in the blood when bulking on the wound surface ,thus concentrating the blood and
   facilitating hemostasis of the wound surface.

Ⅳ.Indication
  1.The produce is widely indicative for use in medical and health facilities ,and wards ,clinics and emergency rooms
   of surgery, traumatology, orthopedics, gynecology , ENT , stomatology, coloproctology and burn surgery owing to
   its remarkable hemostatic effect ;
  2.The product can also be used as a component of the first –aid equipment for
   sudden accidents breaking out in industrial and rural enterprises for on –
   the-spot disaster-combating activities ,or for war –time and peace –time
   first-aid in the armed and police forces by taking advantage of quick action
   of the membrane so as to save more casualties form death due to excessive
   bleeding .
  3.The product is also useful for hemorrhagic wounds from accidental injuries
   during household ,touring adventure and spors activities.

Ⅴ. Contraindication
  1.This soluble and hemostatic membrane should not be used for contaminated or severely infected wounds ,or wounds or
   wounds contaminated with foreign ,objects , or wounds of inadequate drainage with pus oozing.
  2.If wound bleeding involves an intemediate or large artery ,the immediate thing is to apple compression hemostasis by
   
pressing on the centripetal end before ueing the membrane;
  3.Type 01 AND 02 membrane is only for hemostasis of wounds on the body surface ;for bleeding form endoceliac
   sufaces, use Type 03 series.

Ⅵ.Usage
  1.Clean and disinfect the hemorrhagic wound surface ,choose a membrane of
   theirs of membrane of appropriate size according to the wound area and the
   amount of bleeding , apply it to the wound surface directly and fix with a
   medical gauze and bandage;
  2.If wound bleeding involves and intermediate or large artery, the immediate
   thing is to apply compression hemostasis by pressing on the centripetal end
   before ueing the membrane ,if the wound is penetrating ,roll the membrane
   into a cylinder and fill in into the would so that it produces a better hemostatic effect .The melted gelatin can be absorbed
   completely by the body;
  3.For infected wounds ,effective antibiotic therapy and antitetanicum serum therapy should be instituted other than use of the membrane.

Ⅶ.Storage

  1. Keep from moisture and high temperature baking .The store room should be dry and well ventilated ,keeping room
    temperature between –50℃ and 60℃;
  2. Expiry date :Two years;
  3. If the small package is found to have been damaged ,dispose be the product and do not use it.

 
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