Disposable Curved Cutter Stapler
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|Min. Order:||1 Piece|
|Production Capacity:||100, 000PCS/Year|
|Payment Terms:||L/C, T/T, Western Union|
- Model NO.: CSYH-45
- Feature: Disposable
- Medical Devices Reg./Record No.: Syzz2012 2080461
- Anvil and Cutter: 12cr18ni9
- Outside Diameter: 0.22
- Number of Staples: 46
- Trademark: changsheng
- Specification: ISO/CE
- HS Code: 90189090
- Material: Ta1/Ta2;12cr18ni9;ABS
- Medical Device Regulatory Type: Type 2
- Stapler Staple: Ta1/Ta2 (Titanium Wire)
- Cartridge: ABS
- Staple Height: 4.8±0.3
- Color: Green
- Transport Package: Single Pack, Pet Box, Tyvek Paper
- Origin: Changzhou
I. Product Performance
The disposable curved cutter stapler is an instrument capable of hitting four rows of stapler staples staggered in a curved line, as well as an instrument capable of cutting off tissue. It has good cutting and suturing abilities.
II. Scope of Application
It is applicable to mutilation, excision and suture in the operation of alimentary canal such as stomach and intestines.
III. Graphic Symbols and Definition
IV. Instructions for Use
1. Take out the stapler from the packaging box in the sterile area, and place the tissue to be sutured between the cartridge and the anvil according to figure (8).
2. Grip the stapler as shown in figure (9) to move back the free handle half the moving range where the free handle will not reset when the hand is released. Then adjust properly the position of the tissue between the cartridge and the anvil to make it at an appropriate position with no overlap. Continue to grip when the tissue is well adjusted to move the free handle back to the rearmost position where a "snap" sounds. Now the sutured tissue is compressed between the cartridge and the anvil; loosen the free handle, it will automatically restore to the opening position, (figure 10), while the sutured tissue is already clamped between the anvil and the cartridge.
3. Grip the stapler again to move the free handle back to the rearmost position (figure 11), and now the stapler staples in the cartridge is fired to suture and cut off the tissue.
4. Then the free handle is locked to complete the suturing and cutting.
5. Press the reset button to let the free handle bounce off automatically, and release the locating button to remove the stapler.
1. The tissue has inflammation, edema or tumor.
2. The tissue is so thick (two layers of gastrointestinal wall, when compressed, is estimated to be more than 2.5~3mm) that the stapler cannot penetrate it.
3. The tissue is so thin that putting in the stapler may tear it.
4. In principle, it is inappropriate for mechanical suturing again if the first one fails.
1. The instrument can only be operated by doctors who have received adequate training and get familiar with operation skills.
2. Be sure to check the sutured tissue for bleeding when the instrument is removed; if there is blood oozing, proper methods shall be adopted to stanch bleeding.
3. Please check the package carefully before use; it is prohibited to use if the package is damaged.
4. The product has been sterilized by ethylene oxide, and its validity period of sterilization is three years, so that please check whether the product is within the validity period. If the validity period expires, the product shall not be used.
5. The product is for single use only, so that it cannot be reused even with sterilization again.
The product shall be stored in a well-ventilated room where no corrosive gases exist and relative humidity is not more than 80%.
VIII. Manufacturer and Its Address and Contact Number
Manufacturer: Changzhou Medical Bioengineering Co., Ltd.
Registered (Manufacturing) Address: Tianzhutang, Dongqing, Zhenglu Town, Wujin District 213114 Changzhou City China
Fax: 0519-88964890 Zip Code: 213114
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