Please read all information carefully.
Failure to properly follow the instruction may lead to serious surgical consequence.
Important: This package insert is designed to provide instructions for use of the Disposable Tissue Closure Clamps. It is not a reference to surgical techniques.
【 Intended Use】
Disposable Tissue Closure Clamps is a sterile, non-metallic, non-bioabsorbable clamp designed to be clamp the tissue bundle during the surgical, and would be take out after surgical.
【 Contraindications 】
Disposable Tissue Closure Clamp Not to be used for fallopian tube occlusion.
【 Disposable Tissue Closure Clamp Cautions】
Sterility is guaranteed unless the sterile pouch is damaged or seal is broken.
Disposable device for single use.
Sterilized by ETO Sterilization.
Do NOT re-use or re-sterile.
Check the production and expiry date printed on the sterile pouch.
Do not store in direct sunlight, at extreme temperature, or in high humidity.
Re-use may cause cross-infection.
This device should only be used by trained and qualified practitioners.
【Disposable Tissue Closure Clamp Description】
Disposable Tissue Closure Clamps is composed of plastic clamp, fix cover and base, and classified based on the size of dimensions, i.e.: P-ZJ-S (Small), P-ZJ-M (Middle), P-ZJ-L (Large), the sketch map of Tissue Closure Clamp as following:
Disposable Tissue Closure Clamps specifications:
| Dimension
Type |
a | Tol. | b | Tol. | g | Tol. | j | Tol. | h | Tol. |
| P-ZJ-S | 9.5 | ±1 | 9.4 | ±1 | 26.8 | ±1.5 | 32.5 | ±2 | 14.4 | ±1 |
| P-ZJ-M | 11 | 13 | 26.9 | 32.6 | 16.9 | |||||
| P-ZJ-L | 15.5 | 16.5 | 28.7 | 34.1 | 17 |
It is made of plastic materials, POM, and designed with a self-locking catch. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries.
Its non-metallic design makes it more compatible with radiological imaging, e.g. X ray, CT, MRI.
Disposable Tissue Closure Clamp Performance
The ligation scope of plastic clamp, ligation tissue diameter: 6mm~10mm for type P-ZJ-L; 3mm~6mm for type P-ZJ-M and 2mm~4mm for type P-ZJ-S;
If a ligature lock is completely clamped, no cracks or breakage will occur. When ligature lock is completely clamped, it should bear the tension of 5N, no deformation, no loosening and no fracture;
The phenomenon of ligation and locking is not allowed to fall off after loading the base.
Post time: Dec-22-2021
