Disposable Surgical Linear Stapler with CE Mark (Model A)

• Customization: Available
• Application: Abdominal
• Material: Ta1/Ta2 (Titanium Wire);ABS;12cr18ni9
• Model NO.: CSYF(A)-90
• Feature: Disposable
• Certification: CE
• Group: All
• Outside Diameter: 0.28
• Staple Height: H3.8±0.3 ; H4.8±0.3
• Number of Staples: 33
• Color: H Blue; H Green
• Transport Package: Single Pack
• Specification: ISO/CE
• Trademark: changsheng
• Origin: Changzhou
• HS Code: 90189090
• Production Capacity: 100, 000PCS/Year

Product Description

Disposable Surgical  Linear Stapler (Model A)(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 A)
1.    Take out the stapler from the packaging box in the aseptic area, and then remove the cartridge cover gently.
2.    Clamp the tissue to be stapled between the cartridge and the anvil, and manually push the locating button to move the locating pin into the locating pin hole; be sure to keep the tissue between the cartridge and the anvil, without spillover; or press the closing handle to automatically push the locating pin into the locating pin hole; then a "click" sounds, indicating that the instrument enters the middle locking position; in this state, the locating pin has totally entered the locating pin hole, with the jaw not fully closed to adjust the tissue to the desirable position.
3.    Press the closing handle again, and then the instrument clamps the tissue entirely to get ready for suture.
4.    Press the firing handle to the fixed handle, and then the tissue is entirely sutured.
5.    Press the reset button with thumb to reset the cartridge automatically, and then pull the locating button to get back the locating pin from the stapler; now the operation is completed.

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(A)-30(H/h)	35.2	4.8	3.8	13
CSYF(A)-45(H/h)	50.5	4.8	3.8	19
CSYF(A)-60(H/h)	63.2	4.8	3.8	25
CSYF(A)-75(H/h)	80.2	4.8	3.8	31
CSYF(A)-90(H/h)	95.7	4.8	3.8	33
CSYF(A)-90M(H/h)	95.7	4.8	3.8	39