The stapler shall be opened and closed flexibly without jamming
The stapler shall be equipped with empty nail bin safety protection device (not firing) and maintain its reliability.
Note: empty nail bin refers to the components that have been fired.
After the stapler is installed into the adapter assembly, it shall have good anastomosis and cutting performance: replace 5 adapter assemblies on thesame stapler for anastomosis and cutting respectively. It should be easy to push the button by hand when kissing and cutting; The cutting edge after kiss cutting shall be neat and free of burrs; The anastomotic length is at least 1.5 times longer than the cutting length; The anastomotic nails after anastomosis shall be staggered in parallel and arranged in a straight line without missing nails; The staples are shaped into a "B" shape.
After replacing the components of another model and specification, they should also have good matching and cutting performance: replace 5 components of another model and specification on the same stapler and do matching and cutting respectively. The kissing process and kissing effect shall meet the provisions of 2.4.3.
Withstand voltage performance
The anastomotic stoma after anastomosis shall be able to withstand the pressure of no less than 3.6kPa, and the water leakage shall not exceed 10 drops within 15s.
Surface roughness
Surface roughness of exposed metal surface of stapler and components RA ≤ 0.8 μ m.
Appearance
The stapler and its components shall be smooth in appearance, clear in outline, free of burr, scratch and other defects. The shell shall be free from cracks and obvious deposits.
The handwriting and marks on the outer surface of stapler and components shall be clear, and there shall be no dislocation, skew and other defects.
The head end of the staples shall be sharp and the surface shall be smooth without burrs, dents and other defects.
The cutting knife shall be sharp and free from defects such as rolling edge and broken edge.
Basic dimensions
The size of stapler and components shall comply with the provisions.
Sterility
The stapler and components shall be sterilized with ethylene oxide, and the products shall be sterile.
Ethylene oxide is used for sterilization. When the stapler and components leave the factory, the residual amount of ethylene oxide shall not be greater than 10% μ g/g.
Packaging and sealing
The package of stapler and components shall be intact, and there shall be no channel or perforation in the bonding and sealing area.
The peel strength of the packaging and sealing of stapler and components shall not be less than 0.10 n / mm. After stripping, the two contact surfaces shall be smooth, continuous and uniform without delamination or tear.
Post time: Apr-08-2022
