MINT-LOC™
| Instructions for Use |
This is an absorbable suture made of polydioxanone material, which includes a needle, loop, or tack. |
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| Instructions for Use |
Preparation Before Use 1) The user must be proficient in surgical procedures and techniques related to sutures. 2) The user must be well-acquainted with the physical properties of the suture material, and the choice of suture should be based on the patient's condition, surgical experience, technique, site, and size. The risk of wound rupture can vary depending on the application site and the suture material used. Information about the thread, barb size, and physical performance of MINT-LOC™ is provided in the table below. Care should be taken not to apply excessive force beyond the specifications of the suture, as this could result in suture breakage or separation of the needle. 3) Check for any damage, contamination, or expiration date on the product packaging. Do not use products with any defects. 4) Ensure the patient's condition is stable before proceeding with use. Instructions for Use 1) Check the product's packaging and expiration date. If there are no issues, open the package and verify that the product is intact. 2) To start a continuous suture pattern, align the two edges of the tissue. 3) For loop or tack end fixation 3-1) For Loop Sutures: After placing the suture with the attached needle, pull the suture until the loop at the opposite end approaches the tissue. Pass the needle through the loop, pull it tight, and fix the suture in undamaged tissue. 3-2) For Tack Sutures: After passing the needle through the tissue, pull the suture to secure the tack at the opposite end into undamaged tissue. 4) Once the loop or tack is visually fixed on the tissue surface, continue suturing, applying appropriate tension to bring the tissue edges together. 5) Continue with a continuous suture pattern, ensuring not to overtighten the suture during the process. 6) To finish suturing deeper tissues, reinforce the final junction with 2 additional stitches for support. 7) After completing the suture, pass the product vertically through the incision and pull it out from the skin surface. 8) Adjust the suture on the skin surface and trim the excess suture as necessary. 9) To remove the entire suture, cut the portions fixed with the loop or tack, then pull the distal end of the suture along the direction it was applied to remove it completely. Multiple cuts may be necessary to fully remove the product from the tissue. Storage and Handling After Use 1) This product is for single-use only and should not be reused. 2) As a sterile product, it should be used immediately after opening, and re-sterilization is prohibited. 3) Dispose of used products or expired products according to medical regulations. 4) Dispose of opened packaging in accordance with medical waste disposal laws. |
| Precautions for Use |
Warnings 1) This product is for single patient use only. It must not be used on more than one patient. 2) Do not use this product in patients who have hypersensitivity reactions to the suture material, polydioxanone. 3) This product is not intended for suturing cardiovascular or neural tissues, or tissues that require long-term (over 30 days) high tensile strength. It should not be used for permanent fixation of artificial devices. 4) The safety and efficacy of this product have not been established for suturing fascia, gastrointestinal anastomosis, cardiovascular anastomosis, neural, ophthalmic, or microsurgical procedures. Do not use for these purposes. 5) This product may form stones when exposed to urine or bile in urological and biliary surgeries over extended periods. 6) This product should only be used by qualified medical professionals who have completed specific training for the procedure. 7) The risk of wound rupture may vary depending on the procedure and the suture material used. A surgeon must be familiar with the surgical techniques and procedures related to absorbable sutures before use. 8) The surgeon should consider the volume and quality of tissue when placing the loop or tack. Sutures should not be used in tissues that cannot withstand the pressure exerted by the loop or tack, such as highly vascular tissues or those that cannot tolerate compression. 9) When draining and suturing infected wounds, widely accepted surgical principles should be followed. 10) Management of infected or contaminated wounds should adhere to acceptable surgical practices. 11) Do not re-sterilize or re-use this product. Dispose of unused products, products with damaged packaging, or products past their expiration date. 12) Be cautious to avoid breaking the suture needle. A broken needle may cause foreign body presence or require additional surgery. 13)Users should avoid injury from the suture needle. Accidental needle pricks can transmit bloodborne infections. Considerations for Specific Patient Groups 1) This product may be inappropriate for patients with conditions that delay wound healing or for frail patients. 2) As this is an absorbable suture, if the tissue is expanding, stretching, or requires additional support, non-absorbable sutures should be used in conjunction. Confirmation by a doctor is required. 3) If suturing a contaminated or infected wound, appropriate surgical intervention should be performed. 4) If the suture remains in place for more than 7 days, local irritation may occur. Follow the proper procedure for removing external sutures. 5) Exercise caution when using this product in areas with inflammation, wound contamination, or infection concerns. Precautions for Fatal Adverse Effects or Accidents Due to Misuse 1) This product is for single-use only; do not reuse. 2) Ensure the product is in a sterile condition before use. 3) Do not use if the packaging is torn or damaged. 4) Do not use products past their expiration date. 5) Take care to avoid contamination. If a product is found to be contaminated, dispose of or return it. |