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Disposable Linear Stapler Pass CE and ISO Certificates (ZYF)

Basic Info

Model No.:  ZYF-30/45/60/90

Product Description

Model NO.: ZYF-30/45/60/90 Application: Abdominal, Anorectal, Urology Feature: Disposable Group: Adult Product Name: Disposable Linear Stapler Model: Zyf-30/45/60/90 Leading Time: 3-5days for Trial Order, 10-15days for Bulk Order Specification: CE0197, ISO HS Code: 90189090 Type: Surgical Stapler Material: Titaninum Certification: CE, ISO13485 Medical Devices Reg./Record No.: Cfda-2081081 Certificate: Ce, ISO MOQ: 1PC Trademark: Haiers Origin: China(Mainland) Linear Stapler, CE and ISO certificates
I.  Product Description
The disposable linear stapler delivers two staggered rows of titanium staples in order to approximate internal tissues. The instrument is available in four sizes to accommodate different tissues: 30mm,45mm, 60mm and 90mm.
The ZYF series linear stapler is a single-patient-use device. The device delivers two staggered rows of titanium staples to suture the tissue or organs.
We have two kind of staple height cartridges which provide the versatility to deliver appropriate compression for the targeted tissue.
  
APPROVAL: CE and ISO certificates
MATERIAL: titanium
MODEL: ZYF-30L, 30H, 45L, 45H, 60L,60H, 90L, 90H
Single use only, avoid cross infection
We also supply OEM service
 
 II. Scope of Application
It is applicable to suture in the operation of alimentary canal such as esophagus, stomach and intestines.


III. External Structure

IV.  Instructions for Use
1. Remove the stapler from the internal packing. Take down protection cover, keep the stapler open.
2. Confirmation before firing: A)cartridge is suitable for suture tissue; B) suture tissue has been in the suture area.
3. Hold the feed handle to the first position, first sound will prompt, meanwhile position setting pin will come into anvil automatically. Suture tissue has been limited in the suture area. It is still can been adjusted exactly.
4. Put in order tissue in suture area, make it smooth.
5. Hold the feed handle to the second position, second sound will prompt, it means tissue has been locked completely.
6. Press firing button to finish suture. (if need cutting, make sure it happen before reset. )
7. Press firing button to withdraw product.
8. Check suture condition, if hemorrhagic spot is found, it should be sutured to stop bleeding.

V. 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.
 
VI. 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.
 
VII. Storage
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


Model
Cartridge Model Staple Height(mm) Number of Staples Color of Cartridge Suture Length(mm) Suture Thickness(mm)
ZYF-30L ZYFZ-30L 3.8 11 Blue 31.5 1.0-2.0
ZYF-30H ZYFZ-30H 4.5 11 Green 31.5 1.5-2.5
ZYF-45L ZYFZ-45L 3.8 15 Blue 47 1.0-2.0
ZYF-45H ZYFZ-45H 4.5 15 Green 47 1.5-2.5
ZYF-60L ZYFZ-60L 3.8 21 Blue 59 1.0-2.0
ZYF-60H ZYFZ-60H 4.5 21 Green 59 1.0-2.0
ZYF-90L ZYFZ-90L 3.8 33 Blue 92 1.0-2.0
ZYF90H ZYFZ-90H 4.5 33 Green 92 1.5-2.5
Manufacturer: Changzhou Haiers Medical Deveices
Address: No. 2188 Longcheng Rd, Zhonglou District, Changzhou City China
Tel: 0519-68860671                                 
Fax: 0519-68881966                                
Zip Code: 213012
Web: www.hasmedicalstapler.com

We are Chinese Medical Stapler company, we have many years' experience in this area. Our medical stapler major for surgery and the quality is the same as J&J, Tyco. It can be instead of those famous brand. Our products series include: Disposable Circular Stapler, disposable Hemorrhoids Stapler, linear cutter, auto linear stapler, disposable reloadable linear stapler.

IX. Package
The inner packing is sterilized and sealed plastic container. The medium packing is carton and each carton has one piece of instrument with certificate and instruction. The outer packing is corrugaled case. 

Contact us if you need more details on Disposable Linear Staplers. We are ready to answer your questions on packaging, logistics, certification or any other aspects about Surgical Staples、Laparoscopic Instruments. If these products fail to match your need, please contact us and we would like to provide relevant information.

Product Categories : Disposable Linear Surgical Stapler