Oocyte collector DQ-17GClass II medical devices
【Production license No】辽食药监械生产许20180016号
【Medical device registration certificate No】辽械注准20172130209
【Product technical requirement No】辽械注准20172130209
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）No acute systemic toxicity;
3）The product should not be cytotoxic;
4）The product has no hemolytic reaction;
5）Other technical indicators of the product should meet the "Oocyte collector technical requirements".
Oocyte collector is composed of Oocyte collection needles (SUS304), protective sheath, handle, anti-folding sleeve, negative pressure catheter (Tecothane series TT-1095A), vacuum catheter, Luer taper, silicone plug.
The scope of products:
This product is used to collect oocytes from ovarian follicles via the vagina under the guidance of ultrasound.
1）Those with acute inflammation of the whole body and reproductive system.
2）Those who are prone to vaginal bleeding.
Precautions, warnings, and suggestive description:
1）The product is used by trained professionals;
2）This product is disposable and needs to be destroyed after use;
3）This product needs to be used immediately after unpacking;
4）If the packaging of the product is damaged or the protective sheath falls off, it is forbidden to use;
5）Do not use if foreign matter is found in the package;
6）When operating this product, it is forbidden to touch the parts of the steel needle with your hands or unsterilized items;
7）If bleeding occurs in the vagina after collection, pressure can be applied with a sponge or surgical instrument, or sutured with an absorbable surgical thread.
Label, Identified graphics, symbol compilation:
1）After the patient is placed in the lithotomy position, the vulva and vagina are disinfected, and the sterile surgical sheet is covered on the patient;
2）Cover the ultrasonic sensor by using a sterile polyethylene sleeve and cover the ultrasound probe in the sleeve with a small amount of coupling agent. Introduce it into the vagina to view the pelvis to determine the location of the uterus, the endometrium, and the number and location of oocytes collected;
3）Unpack the product and insert Oocyte collection needles into the pinhole of the sensor to ensure that it has enough free movement space;
4）Connect a sterile plastic test tube to the silicone plug, and then connect the syringe or vacuum pump to the Luer taper of the vacuum tube;
5）Extend the ultrasonic sensor and Oocyte collection needles into the vagina, and align the probe to the posterolateral side of the vaginal vault. Debug the probe until you see follicles near Oocyte collection needles;
6）Puncture Oocyte collection needles into the follicle closest to it, and extract all the contents of the follicle through the negative pressure of the syringe or vacuum pump. By gentle manipulation, the oocyte is detached from the follicle wall. After the extraction, extract Oocyte collection needles from the follicles and perform the same extraction operation on the next follicle;
7）When a test tube is filled, remove the silica gel plug from the plastic test tube and replace the second test tube;
8）When the follicles in one ovary are collected, repeat operations 6 and 7 in the other ovary;
9）Remove the sensor and family oocyte collection needs. Check the vagina for signs of bleeding. If all is well, let the patient have a good rest.
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 the heavy pressure, direct sunlight, and rain, and snow.
The product is valid for three years after the sterilization date.