[product name] disposable arc stapler and components

[specification and model] jqha-45, jqhb-45

[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 20162080717

[product technical requirements No.] yxzz 20162080717

[structure and composition] the disposable arc stapler and its components (type A) are composed of nail holder, nail bin, component splint, positioning needle The disposable arc stapler and components (type b) are composed of nail holder, nail bin, component splint, positioning needle, positioning button, reset button, fixed handle, movable handle, cutting knife and anastomotic nail.

[product performance] 1. The arc stapler has smooth appearance, no sharp edge, burr and crack. The marks on the body of the stapler are clear; the shell of the stapler is firmly bonded without cracks and obvious accumulation; the outer surface of the metal parts is bright without burr, dent and other defects; 2. Service performance: the moving parts of the arc stapler can be pushed easily without jamming and loosening. The back of the assembly loader is firm, and the anastomotic nail does not fall off; the head of the stapler is sharp, and the stapler is in "B" shape after anastomosis, and the cutting knife has no curling edge or chipping edge; the return spring of the arc stapler has enough elasticity, and the movable handle of the reset button can be quickly reset after the anastomosis is completed; 3. The hardness of the annular knife is not less than 377hv0.2; 4. The arc The results show that the surface roughness of the metal parts of the stapler is RA ≤ 0.8 μ m; 5. The peeling strength of the packaging sealing is 0.1n/mm ~ 0.5n/mm, and the two contact surfaces are smooth, continuous and uniform without delamination or tearing; 6. The stitching mouth after anastomosis can withstand the pressure of no less than 3.6kPa, without water leakage and tearing. 7. The product is sterile; 8. The residual amount of ethylene oxide shall not be more than 10ug / G after sterilization with ethylene oxide. 9. There are slight corrosive marks on the surface of the metal parts of the arc stapler, which can be removed by wiping.

[scope of application] it is suitable for the reconstruction of digestive tract and the closure of stump or incision in the operation of digestive tract reconstruction and organ resection.

[contraindications] 1. There are inflammation, edema or tumor sites in tissues;

2. The thickness of the two layers of gastrointestinal wall was more than 2.5 ~ 3 mm after the two layers of gastrointestinal wall were pressed together, and the suture nail was not transparent;

3. The tissue is too thin to prevent tissue tearing when the stapler is inserted;

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 professional 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 the disposable arc stapler and its components (type A)

1. In the sterile operating room environment, take the instrument out of the package. Handle the equipment with care to avoid collision or falling to the ground, which will affect the performance of the product;

2. Remove the nail bin cover, put the tissue to be sutured between the nail holder and the kissing component. After pressing the closing handle, a click indicates that the positioning needle has entered the locking position in the positioning hole; at this time, the distance between the jaws is reduced, which is convenient to adjust the tissue to the ideal sewing position;

3. When the tissue reaches the ideal position, press the closing handle again to close the jaw. At this time, the tissue to be sewn is fixed and waiting for sewing;

4. After the tissue is fixed, press the firing handle with force, and then the tissue is cut off and sutured;

5. After sewing and cutting, press the reset button to reset the nail bin automatically, and then pull the positioning knob to make the positioning needle return. When the stapler was withdrawn slowly, the stapler was used. Do not use violence or forcibly withdraw the device.

Usage of disposable arc stapler and components (type b)

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. Take off the nail bin cover, put the tissue to be sutured between the nail holder and the cutting component, gently press the movable handle to release, the handle will not rebound when it moves backward ≤ 2cm, and a click indicates that the positioning needle has entered the locking position in the positioning hole; at this time, the distance between the jaws is reduced, which is convenient for adjusting the tissue to the ideal sewing position;

3. After the tissue reaches the ideal position, press the movable handle again to press the movable handle to the fixed handle. At this time, the jaw will be closed. Gently release the handle and the handle will rebound to the front end. At this time, the tissue to be sewn is fixed and waiting for sewing;

4. After the tissue is fixed, press the movable handle again to make the movable handle press to the fixed handle. At this time, the tissue is sutured, and the handle will not rebound when the handle is gently released;

5. After sewing and cutting, press the reset button to reset the nail bin automatically, and then pull the positioning knob to make the positioning needle return. When the stapler was withdrawn slowly, the stapler was used. Do not use violence or forcibly withdraw the device.

[storage method]

1. The application of this product is covered