Disposable Linear Stapler (CE mark)

• Customization: Available
• Material: Ta1/Ta2 (Titanium Wire);ABS;12cr18ni9
• Feature: Disposable
• Model NO.: Model B
• Staple: Ta1/Ta2 (Titanium Wire)
• Cartridge: ABS
• Anvil: 12cr18ni9
• Transport Package: Pet Box, Tyvek Paper
• Specification: ISO/CE
• Trademark: changsheng
• Origin: Changzhou
• HS Code: 90189090
• Production Capacity: 100, 000PCS/Year

Product Description

Disposable Linear Stapler Model B(CE mark)
 

I.     Product Performance

The disposable linear stapler puts staples staggered in a line into the tissue to replace manual suture. This instrument can save operation time and reduce bleeding. Besides, it is convenient for surgical suture.
 
II.   Scope of Application
It is applicable to suture in the operation of alimentary canal such as esophagus, stomach and intestines.

III.Name of Parts


IV.Graphic Symbols and Definition


V.  Instructions for Use(Model B)
1.    Take out the stapler from the packaging box in the aseptic area, and place the tissue to be stapled between the cartridge and the anvil.
2.    Grip the stapler 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 anvil and cartridge 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, 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, and now the stapler nails in the cartridge is fired to suture the tissue.
4.    Then the free handle is locked to complete the suturing.
5.    Press the reset button to let the free handle bounce off automatically, and release the locating button to remove the stapler.

VI.       Contraindication
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.
5.    The instrument is forbidden to be used for such tissue as liver and spleen, because the compression of the tissue due to the instrument closing is destructive to the tissue.
 
VII.      Notes 
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.
6.    Be sure to choose suitable specification of assembly according to the tissue thickness; too thick or too thin tissues many cause bad nail forming.
 
VIII.  Storage
The product shall be stored in a well-ventilated room where no corrosive gases exist and relative humidity is not more than 80%.
 
IX.   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
Tel: [phone]                                  
Fax: [phone]                                  Zip Code: 213114
 

Model	Suture Length	Staple Height		Number of Staples
		Green	Blue
CSYF(B)-30(H/h)	39	4.8	3.8	11
CSYF(B)-45(H/h)	50	4.8	3.8	15
CSYF(B)-60(H/h)	66.5	4.8	3.8	21
CSYF(B)-75(H/h)	83	4.8	3.8	27
CSYF(B)-90(H/h)	99.5	4.8	3.8	33