OSSTOP™
| Product Introduction |
This product is a biocompatible, water-soluble polymer composition |
|---|---|
| Intended Use |
Purpose of Use This product is used to control bleeding from bone surfaces during surgical procedures by providing hemostasis through an absorbable material. Preparation Before Use 1) Check the product for any damage or deformation. If any abnormalities are found, do not use the product. 2) Determine the necessary amount based on the size of the affected area and the amount of bleeding, and select the appropriate model for use. 3) Since this product is supplied in a sterile condition, ensure that the packaging is intact and not damaged. If damaged, dispose of it immediately. Usage Method and Procedure 1) Open the sterile packaging in the surgical environment. 2) Handle the product while wearing surgical gloves, and the procedure should be performed in a sterile condition using surgical tools by a specialist. 3) Place the product on the bleeding bone area and apply pressure. 4) Based on the size of the affected area, tear off an appropriate amount, knead it for 30 seconds to 1 minute until it reaches the desired viscosity, then apply it to the bleeding site to induce hemostasis. 5) Confirm whether hemostasis has been achieved. 6) Apply the appropriate amount to the affected area, and avoid excessive use. Post-Use Storage and Management 1) This is a single-use product; do not sterilize or reuse it. 2) Any remaining product should be disposed of according to medical waste disposal regulations. 3) Dispose of the opened packaging as medical waste in accordance with waste management laws. |
| Precautions for Use |
Warnings 1) This product should not be used for purposes other than its intended use. 2) Do not use this product in patients who are allergic to the raw material (Poloxamer). 3) This product is for single use only; do not reuse or re-sterilize. Dispose of any unused product, damaged packaging, or expired products immediately after opening. 4) This product should only be used by qualified healthcare professionals who have completed specialized training for the procedure. Do not use it otherwise. Intended Users 1) Patients with bone fractures or those who have undergone surgery resulting in bone bleeding. 2) This product is not for use for purposes other than bone hemostasis. Adverse Reactions 1) Using this product in a contaminated environment may lead to infection; care should be taken to maintain a sterile environment. 2) If used in small amounts, rebleeding may occur in the treatment area. Ensure the product covers the entire bleeding site with a uniform thickness. 3) For patients on anticoagulants such as aspirin or Plavix, bleeding times may be prolonged. Carefully assess the amount needed and monitor progress during use. General Precautions 1) Before use, thoroughly review the product's instructions and procedures. 2) Store the product in a cool, dry place, away from direct sunlight, and maintain a temperature of room temperature. 3) Do not freeze or heat the product during use. 4) Apply only the appropriate amount of the product to the affected area, avoiding excessive use. Interactions 1) Do not use this product in combination with other medical devices at the treatment site. Usage in Special Populations 1) Not applicable for pregnant, breastfeeding women, women of childbearing age, neonates, infants, children, or elderly. Application Precautions 1) Do not use this product to provide structural support to bone. 2)Prior to application, thoroughly knead the product (for 30 seconds to 1 minute) until it reaches the desired consistency. 3) When used in long surgeries, ensure that saline or other solutions do not wash away the product from the bleeding site. Safety Measures to Prevent Accidents 1) If the sterility of the product is compromised before use, dispose of it immediately. |