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disposable straight line stapling and components

  • product description
  • performance and use

[product name] use linear stapler and components at one time.

[specifications] jqza-30, jqza-45, jqza-60, jqza-75, jqza-90.

[name of registrant] henan jianqi medical equipment co. ltd.

residence: the dingluan industrial zone, changyuan county, henan province.

[contact number] 0373-8690789.

【 after-sales unit 】 henan jianqi medical equipment sales co. ltd.

[name of production enterprise] henan jianqi medical equipment co., ltd.

residence: the dingluan industrial zone, changyuan county, henan province.

[production address] dingluan industrial zone, changyuan county, henan province.

[contact information] 0373-8690789.

[production license] the food and drug regulatory apparatus is permitted to be made in 20080036.

[registration certificate no.] yu ordnance note 20162080721.

[product technical requirements no.]


one-time use linear structure and composition 】 【 stapling and component by the arrival of the nail seat, protective cover, nail storehouse, components, labeling, positioning push button, the reset button, handle, the handle;

[product performance] 1. the shape of linear stapler should be flat, smooth, without front edge, burr and crack, and the scale value and mark should be clear; the scale or mark on the body should be clear, no dislocation and skew; the bond of the straight type stapler shell should be firm, no cracks and obvious accumulation, the outer surface of the metal parts should be bright, no burrs and flying edges. 2. performance: the insurance mechanism of the linear stapler is open and closed, and the use should be safe; the reposition spring of the straight line stapler is elastic enough to be rearranged quickly when the handle is released. the nail head is sharp and the stitching is "b" after suture. it can be easily assembled and disassembled, easy to replace and reliable. the mobile parts can be easily pushed, open and closed flexibly, no jam and loosening phenomenon; the nailing loader is firmly behind, and the stud is stable in the nailing, and it does not fall off after shaking. 3. the surface roughness of the metal parts of the linear stapler is less than 0.8mm; 4. the peel strength of the packing seal is 0.1n /mm ~ 0.5n /mm, and the two contact surfaces that are torn are smooth and continuous, without layering or tearing. 5. after the anastomosis, the suture should be able to withstand the pressure not less than 3.6kpa, without leakage or tear; 6. straight line stapler should be sterile; 7. straight line stapler is sterilized by ethylene oxide, and the residual amount of ethylene oxide is not greater than 10ug/g; 8. the surface of the metal parts of the linear stapler is slightly corroded and can be removed after wiping.

[scope of application] applicable to the reconstruction of the digestive tract and the closure of the stump or incision in the anastomotic opening of other organs.

[contraindications] 1. the tissue has inflammation, edema or tumor site;

2. the liver and spleen tissues are prohibited;

3. disabled people with coagulation mechanism;

4. it is forbidden to be allergic to product materials.

1. this product is a disposable product, which is damaged in packaging and is strictly prohibited to be used and destroyed after use.

2. if the production batch number and expiry date are shown in the packaging seal or label, the sterilization date is in the outer packing box;

3. ensure the packaging is in good condition before use;

4. the product is used by doctors and personnel after the knowledge and technical training of the stapler;

any falling to the ground or being damaged or suspected of damage due to improper disposal shall not be used in clinical practice.

1. please check the hemostatic condition of the stitching thread after each breakdown and exit. if there is blood seepage, appropriate methods must be used to stop the bleeding.

2. the first mechanical suture fails, and the mechanical suture is not suitable in principle;

3. before the device is locked, the positioning pin must be in place, mainly to prevent the movement of the moving body and influence the correct shaping of the stitching.

[use method] the use of straight line cutting stapler and component in one time:

1. select the applicable model specifications and take out the equipment from the packaging in the sterile operating room environment. in order to avoid damage, it is necessary to gently remove the equipment to avoid collision or falling land;

2. remove the cover, will need to stitch the organization into the nail seat and kiss cut between components, the handle gently press activities to loosen, handle back 2 cm or less will not rebound, hear clicks said positioning needle has entered the location hole in the locked position; at this point, the distance between the jaws is reduced to facilitate the adjustment of the tissue to the desired slot.

3. the organization to the ideal sewing and cutting position, press activities make activity joystick press again to handle fixed jaw will be closed at this moment, gently loosen the grip handle will rebound to the front, at this time to sew cutting seam organization fixed waiting for cutting;

4. press the active handle to press the activity handle to the fixed handle once again after the organization has been fixed, and then the stitching will be completed and the handle will not be returned;

after finishing the sewing, press the reset button and the pin position automatically reset, then pull the positioning push button to return the positioning pin. slowly exit the stapler to complete the use of the stapler; do not use force or force out of equipment.

operation method of replacing components with linear stapler and components at one time:

ensure driving back to the original position, remove has used components and discarded, new components, new components into the component within the frame, a fixed component location, remove the protection cover, can according to the using method used in the same operation using the same patients.

[storage method] 1. the product is used in the carriage and hold of the cabins, and is kept clean, without pressure, sunshine and rain or snow;

2. handle gently in handling and avoid violent collision;

3. the product shall be stored away from the fire source, and the relative humidity shall not exceed 80%, without corrosive gas and well-ventilated and clean environment;

[production date] see the packing seal or label.

expiry date: see the packing seal or label.

[label, package logo]

[specification preparation date] november 21, 2016.


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