[product name] disposable linear stapler kit

[specification and model] jqza-30, jqza-45, jqza-60, jqza-75, jqza-90.

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

[address] dingluan Industrial Zone, Changyuan County, Henan Province

[Tel.] 0373-8690789

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

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

[address] dingluan Industrial Zone, Changyuan County, Henan Province

[production address] dingluan Industrial Zone, Changyuan County, Henan Province

[contact information] 0373-8690789

[production license] ysyjx production license No. 20080036

[Registration Certificate No.] yxzz 20162080721

[product technical requirements No.] yxzz 20162080721 disposable linear stapler and components.jpg

[structure and composition] the disposable linear stapler and its components are composed of a nail holder, a protective cover, a nail bin, a component base, an indication label, a positioning push button, a reset button, a fixed handle and a movable handle;

[product performance] 1. The shape of linear stapler should be flat, smooth, without sharp edge, burr and crack, and the scale value and mark on the body should be clear; the scale value or mark on the body should be clear without dislocation and skewness; the shell of linear stapler should be firmly bonded without cracks and obvious accumulation; the outer surface of metal parts should be bright without burr or flash. 2. Application performance: the safety mechanism of linear stapler is flexible and safe to use; the return spring of linear stapler has enough elasticity and can quickly reset when the handle is released; the stapler head is sharp, and the stitching nail is in "B" shape after stitching; the nail bin and body frame of linear stapler can be assembled and disassembled smoothly, It is convenient to replace and locate reliably; each moving part can be pushed easily, opening and closing are flexible, and there is no jamming and loosening phenomenon; the nail bin loader is firmly behind, and the staples are stable in the nail bin, and there is no falling off after swinging; 3. The surface roughness of the metal parts of linear stapler is RA ≤ 0.8 μ m; 4. The peeling strength of packaging sealing is 0.1n/mm ~ 0.5n/mm, and the two contact surfaces torn are smooth It should be continuous and uniform without delamination or tearing; 5. The suture after anastomosis should be able to withstand a pressure of no less than 3.6kPa without water leakage and tearing; 6. The linear stapler should be sterile; 7. The linear stapler should be sterilized with ethylene oxide, and the ethylene oxide residue should not be greater than 10ug / g; 8. There are slight corrosive traces on the surface of the metal parts of the linear stapler, which can be removed by wiping 。

[scope of application] it is applicable to the creation of anastomotic stoma and the closure of stump or incision in digestive tract reconstruction and other organ resection operations.

[contraindications] 1. Tissue inflammation, edema or tumor site are prohibited;

2. Liver and spleen tissues were forbidden;

3. It is forbidden for patients with coagulation disorders;

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

[precautions] 1. This product is disposable and its package is damaged. It is forbidden to use it and destroy it 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;

3. Before the instrument is locked, the positioning needle must be in place, mainly to prevent the movement of the moving body and affect the correct formation of the suture.

How to use disposable linear cutting 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. 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 is in the ideal position, press the movable handle again so that the movable handle is pressed 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 sewing tissue 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 sewn and cut, and the handle will not rebound after gently releasing the handle;

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. Slowly withdraw the stapler to complete the use of stapler; do not use violence or force to withdraw the device.

Operation method of disposable linear stapler and component replacement component:

Ensure that the pushing block is returned to the original position, remove the used components and discard them, replace them with new ones, put the new components into the assembly frame, fix the position of the components, and remove the protective cover, which can be used for the same patient in the same operation according to the use method.

[storage method] 1. This product should be covered