[product name] disposable tubular stapler and components

[specification and model] jqga-17, jqga-19, jqga-21, jqga-24, jqga-26, jqga-29, jqga-32, jqga-34

[name of registrant] Henan Jianqi medical device Co., Ltd

[residence] dingluan Industrial Zone, Changyuan County

[Tel.] 0373-8690789

[after sales unit] Henan Jianqi medical equipment sales Co., Ltd

[name of manufacturer] Henan Jianqi Medical Equipment Co., Ltd

[residence] dingluan Industrial Zone, Changyuan County

[production address] dingluan Industrial Zone, Changyuan County

[contact information] 0373-8690789

[production license] ysyjx production license No. 20080036

[Registration Certificate No.] yxzz 20162080718

[technical requirements No.] yxzz 20162080718

[structure and composition] disposable tubular stapler and its components are composed of: butting nail base, kissing and cutting components, sleeve, safety button, movable handle, fixed handle, adjusting handle, cushion ring, annular knife and anastomotic nail.

[product performance] 1. The shape of the tubular stapler is flat and smooth without sharp edges, burrs and cracks, and the scale value and mark on the body are clear; the shell and components of the stapler are firmly bonded (or welded) without cracks and obvious deposits; The head end of the stapler is sharp, the surface is free of dents, scratches and other defects, the circular blade edge is sharp, and there is no curling edge breakage phenomenon; 2. Service performance: the butting nail seat component and the body frame of the tubular stapler can be assembled and disassembled smoothly, and each moving part can be pushed smoothly without jamming or loosening; the back of the assembly loader is firm, and the staples do not fall off; The safety mechanism of the tubular stapler and its components should be flexible and safe to use. When the handle is released, the spring has enough elasticity and can return quickly; the end of the stapler is sharp, the annular blade is sharp, and there is no curling edge or chipping edge; 3. The hardness of the annular knife should not be less than 377hv0.2; 4. The surface roughness of the metal parts of the tubular stapler RA ≤ 0.8 μ m; 5. The metal parts of the tubular stapler should have good corrosion resistance; 6. The peel strength of the packaging seal should be 0.1n/mm ~ 0.5n/mm, and the two contact surfaces torn should be smooth, continuous and even without delamination or tearing; 7. The anastomotic stoma after anastomosis with the tubular stapler can bear the The pressure is not less than 3.6kPa, and there is no water leakage and tear phenomenon. 8. The tubular stapler is sterile; 9. The ethylene oxide residue of the tubular stapler is not more than 10ug / G after being sterilized by ethylene oxide. 10. There are slight corrosive marks on the surface of metal parts of tubular stapler, which can be removed by wiping

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[scope of application] it is suitable for end-to-end, end-to-side and side to side anastomosis in digestive tract reconstruction.

[contraindications] 1. Patients with inflammation, edema and tumor of gastrointestinal wall and esophageal mucosa are forbidden;

2. If the esophagus is too thin or the muscle layer of the tube wall is too thin (less than 1.0 mm), it is forbidden;

3. If the tissue is too thick (it is estimated that the total thickness of the two layers of gastrointestinal wall is more than 2.5 ~ 3mm after being compressed), it is forbidden to use it;

4. It is forbidden for patients with coagulation disorders.

5. It is forbidden for those allergic to product materials.

[precautions] 1. This product is disposable. It is strictly prohibited to use if the package is damaged. It should be destroyed after use;

2. The production batch number and expiration date are shown on the seal or label of the package, and the sterilization date is shown in the outer packing box;

3. Ensure the package is in good condition before use;

4. This product is used by doctors and personnel who have been trained in stapler knowledge and technology;

[warning] any person who falls to the ground or is damaged or suspected to be damaged due to improper handling shall not be used clinically.

[tips] 1. Please carefully check the hemostasis of suture thread after each firing and withdrawing from the instrument. If there is bleeding, appropriate methods must be used to stop bleeding;

2. If the first mechanical suture fails, it is not suitable for mechanical suture in principle;

How to use disposable tubular stapler and its components

1. Select the applicable model and specification, and take the instrument out of the package in the sterile operating room environment. In order to avoid damage, the equipment should be handled with care to avoid collision or falling to the ground;

2. Turn the adjusting nut anticlockwise to hold the nail holder tightly with one hand and the fixed handle with the other hand, and pull it in the opposite direction to separate the nail holder from the stapler body, and then remove the protective cover;

3. Put the sleeve on the puncture shaft, insert the tissue that has been packed and ready to be sutured, tighten the purse, and expose the puncture shaft tip from the center of the purse; if double anastomosis technology is needed, make sure that the puncture shaft passes through the center of the suture line, so as to avoid the accumulation of redundant tissue around the puncture shaft;

4. The long rod lengthens the nail holder and helps it to be inserted into the tissue to be sutured, and then the puncture head can be changed to assist the purse making;

5. Tighten the purse on the clasp tube of the nail holder and expose the clasp tube of the nail holder from the center of the purse, and then insert the clasp tube of the nail holder on the puncture shaft of the stapler body;

6. At this time, rotate the adjusting nut clockwise. After the red pointer enters the green range of the indicator window, determine the firing position according to the thickness of mucosal tissue;

7. Open the safety block and press the movable handle to fire. When a click is heard, the sense of strength is lost, indicating that the firing is completed;

8. Complete the firing, reset the firing handle and restore the safety button;

9. Loosen the adjusting nut 3 / 4-1 turn anticlockwise and withdraw slowly, that is to say, the stapler is used; do not use violence or force to withdraw the instrument.

[storage method] 1. The product shall be loaded and transported in the covered carriage and cabin, and kept clean, and shall not be exposed to heavy pressure, direct sunlight or rain and snow;

2. Handle with care to avoid violent collision;

3. The product should be stored away from the fire source, the relative humidity is not more than 80%, no corrosive gas and well ventilated and clean environment;