[product name] disposable linear cutting stapler and components.
湖北11选5开奖Model: type A and type B; Specification: JQQA-55, JQQA-75, JQQA-100; Jqqb-60, jqqb-80, jqqb-100.
[name of registrant] henan jianqi medical equipment co. LTD.
The dingluan industrial zone in changyuan county。
湖北11选5开奖[contact number] 0373-8690789.
湖北11选5开奖【 after-sales unit 】 henan jianqi medical equipment sales co. LTD.
[name of production enterprise] henan jianqi medical equipment co., LTD.
The dingluan industrial zone in changyuan county.
[production address] dingluan industrial zone, changyuan county.
湖北11选5开奖[contact information] 0373-8690789.
[production license] the food and drug regulatory apparatus is permitted to be made in 20080036。
[registration certificate no.] yukon registration 20162080719.
湖北11选5开奖Technical requirements no.
Structure and composition 】 【 disposable linear cutting anastomat and components (type A) by nailing warehouse, nail nail seat stent warehouse rack, stent nail seat cover, activities cover handle, push block, nail, cutting knife and nail cover. (type B) consists of a head, a pin, a locking lever, a locking rod shell, a stud, a shell, a peg, and a nail.
[product performance] 1。 Straight-line cutting stapler and components are smooth and clear, without burr and scratches; The scale value or mark of the device is clear and no misplacement, skew and so on; The bond of the stapler shell is firm without cracks and obvious deposits, and the outer surface of the metal parts is bright without burrs and dents。 2。 Use performance: anastomosis nail head is sharp, after suture, the nail is "B", cutting edge of blade, and the cutting knife has no blade or blade; After anastomosis, the cutting edges are neat and without burrs。 The length of the anastomosis line is 1。5 times longer than the length of the cutting line。 The straight line cutting stapler has the safety protection device of the air-lock warehouse, which increases the safety of the equipment。 It can be assembled and disassembled smoothly, convenient to be replaced, and secure in the position of the anchor loader。 The nailing should be stable, and it will not fall off after shaking。 The moving parts can be easily pushed, open and closed flexibly, without jam or looseness; The spring is elastic enough to reposition quickly when the handle is released。 3。 The hardness of ring knife is not less than 377hv0。2。 4。 The surface roughness of the metal parts of the straight-line cutting stapler is less than 0。8mm。 5。 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。 6。 The cutting edge should be sharp and the cutting force is not greater than 0。8n。 7。 After the anastomosis, the suture should be able to withstand the pressure not less than 3。6KPa, and no leakage or tear。 8。 Straight line cutting stapler should be sterile。 9。 Straight line cutting stapler is sterilized by ethylene oxide, and the residues of ethylene oxide should not be greater than 10ug/g。 10。 The surface of the metal parts of the straight-line cutting stapler is slightly corroded and can be removed by 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。 Severe mucosal edema is prohibited;
2。 Disabled people with coagulation mechanism;
3。 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 packing seal or label, the sterilization date will be 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;
[warning] 1. Any person who falls to the ground or is damaged or suspected of damage due to improper disposal shall not be used in clinical practice.
2。 This instrument should not be used in the liver or spleen tissues, because of the compression characteristics of such tissues, the closure of the apparatus may have a destructive effect;
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, when firing equipment must handle with the arrival of the nail seat bracket tightly closed extrusion activity, when they hear a click sound said equipment has closed, if failed to make the handle for the nail seat bracket tightly closed, can lead to consistent with nail is not fully formed. Incomplete anastomosis may affect the wholeness of the stitching, which can cause leakage or rupture of the suture.
4。 The first mechanical suture fails, and the mechanical suture is not suitable in principle;
[use method] the use of straight line cutting stapler and components (type A and type B) 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. Open the activity handle to the outside, separate the cutting component and the nail holder, and then remove the nailing cap;
3。 Insert the tissue that needs cutting suture into the center of the nail bin and the nail holder, and press the handle to the locking position (note that the moving handle must be pressed in place);
湖北11选5开奖4. Cutting anastomat held steady hand, another hand thumb and forefinger hold down the push block gently push forward to inspire location (cutting knife has not yet started cutting, feel lighter), firstly and then forward to the front end department (now feel is significantly increased, and cutting knife started cutting organization and suture) for the left and right sides of the organization;
5. After the suture is completed, the block will be gently pushed back to the starting position. Note that it is not possible to pull the stapler immediately. The movable handle must be released, and the stapler and pin holder should be separated, and the equipment should be withdrawn, which means that the stapler should be used. Do not use force or force out of equipment.
Note: when the equipment is fired push block after back to the starting position after the built-in safety lock automatically locked, to prevent users reuse equipment result in cutting without suture, until to replace a new nail warehouse;
Operation method of replacing components with straight line cutting stapler and components (type A and type B) at one time:
Ensure driving back to the original position, pull handle, 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。