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Embryo Replacement Catheter QSL-N240

Class II medical devices

Classification code:

6812

Product specification:

【Production license No】辽食药监械生产许20180016号

【Medical device registration certificate No】辽械注准20172120210

【Product technical requirement No】辽械注准20172120210

Product performance and main structure:

The main performance indexes of the product are as follows:

1)The product is sterile. Sterility is valid for three years;
2)Product does not have genotoxicity;
3)No acute systemic toxicity;
4)The product should not be cytotoxic;
5)The product has no hemolytic reaction;
6)Other technical indicators of this product should comply with "Embryo Replacement Catheter Technical Requirements".

Structure:

Embryo Replacement Catheter QSL-N240 consists of a guiding catheter, replacement catheter (Tecothane series TT-1095A), Luer taper, and a protective sheath.
Embryo Replacement CatheterDGT-148 consists of a guiding catheter, replacement catheter (Tecothane series TT-1095A), stainless steel catheter, Luer taper, protective sheath.

The scope of products:

This product is used in combination with syringes to transfer embryos or fertilized eggs through IVF from the vagina to the uterus.

Contraindications:

1)Those with chronic cervicitis or infectious diseases of the cervix.
2)Those with pelvic inflammation or who have just been cured.

Precautions, warnings, and suggestive description:

1)This product is disposable and needs to be destroyed after use;
2)This product needs to be used immediately after unpacking;
3)Do not use if the package is damaged;
4)Do not use if foreign matter is found in the package;
5)During the operation, it is forbidden to touch the catheter with hands or unsterilized matters;
6)After using this product, it should be treated as waste according to the regulations of the hospital or environmental protection department.

Label, Identified graphics, symbol compilation:

Label, Identified graphics, symbol compilation

Instructions:

1)First, open the package to take out the product, and then extend the guiding catheter through the woman's vagina into the uterine mouth;
2)Connect the Luer taper of the replacement catheter to the syringe;
3)Align the tip of the replacement catheter with the culture liquid in the Petri dish, and then pull the syringe push rod to attract a section of liquid;
4)Align the tip of the replacement catheter with the selected embryo in the culture dish, and then pull the syringe to attract the embryo;
5)Place the replacement catheter into the woman's womb through the guiding catheter lumen. Then push the plunger of the syringe to push the embryo and liquid into the uterus to make it adhere to the uterine wall;
6)After the operation is completed, the guiding catheter and replacement catheter need to be removed.

Storage, transportation conditions, and methods:

1)It is necessary to store the product in a clean and well-ventilated environment with relative humidity no more than 80% and no corrosive gas.
2)In the process of transporting products, it is necessary to avoid heavy pressure, direct sunlight, and rain, and snow.

Service life:

The product is valid for three years after the sterilization date.