1. Product description

The Disposable Circular Staplers for Hemorrhoids is used for circumcision of hemorrhoids and hemorrhoidectomy.

Circumcision of the hemorrhoid mucosa is to remove the mucosa and submucosa above the dentate line with a circular knife. At the same time, two rows of interlaced suture needles in a circular arrangement are used to close the incision.

Hemorrhoidectomy is to remove the enlarged excess pathological tissue with a circular knife, and at the same time, drive into two rows of interlaced stitches in a circular arrangement to close the remaining anal cushion tissue.

2. Intended use

The Disposable Circular Staplers for Hemorrhoids and accessories are mainly suitable for selective resection of mucosa on the dentate line.

3. Product performance

1） The staples should be stable when installed in the assembly, without bad deformation, and no falling off after being shaken.

2)  The safety device of the Disposable Circular Staplers for Hemorrhoids should be safe and effective. When used within the specified range of the window, it can be opened and closed flexibly.

3) The return spring of the anorectal stapler should have enough elasticity to be quickly reset when the handle is released.

4) The anorectal stapler should have good anastomosis and cutting performance. After anastomosis, the anastomosis nail will be in a "B" shape, and the ring knife must not have curling or chipping.

5) After anastomosis, the anastomosis should be able to withstand a pressure of not less than 3.6×10³Pa, and there should be no water leakage or tearing.

6) Sharpness: The edge of the ring blade should be sharp, and the cutting force should not be greater than 0.8N.

7) Corrosion resistance: The corrosion resistance of the metal parts of the anorectal stapler should meet the requirements of 5.4b) in YY/T 0149-2006.

8) After the final packaging of the aseptic anorectal stapler and its accessories, the products should be sterilized after the confirmed sterilization process.

9) Residual amount of ethylene oxide: The anorectal stapler and accessories are sterilized by ethylene oxide, and the residual amount of ethylene oxide should not exceed 10μg/g.

4. Product specifications and technical parameters