Titanium Ligation Clip Factory/Titanium Ligating Clip/Titanium Clips Ce ISO

Basic Info

Model NO.	HTD-SC
Type	Surgical Supplies Materials
Material	Titanium/Medical Polymer
Ethylene Oxide Sterilization	Ethylene Oxide Sterilization
Quality Guarantee Period	5 Years
Group	Adult
Logo Printing	With Logo Printing
Size	S, M, Ml, L
Color	Blue, White, Green, Golden
Packing	6 Per Cartridge, 120PCS Per Box
Model	Lt300
Transport Package	Carton
Trademark	HIPROVE/OEM
Origin	China
Production Capacity	200000/Month

Product Description

Medical Titanium Clips

CE and ISO approved

OEM is welcome

We are one of most professional manufacturers for laparoscopic instruments in China.We would like to accept OEM for titanium clips.We can design and printing for your brand.Welcome to visit us to cooperate.

1 Intended use and characteristics of the product

1.1. Intended use: This titanium clip applicator serves as a ligation instrument for human tissues and blood vessels in surgeries.

1.2. Product characteristics

Titanium clips are implantable, non-absorbable instruments which can remain in the human body for a prolonged time. Made of pure titanium (Ti1) which causes no tissue reaction or adhesion, titanium clips with excellent biocompatibility are the first choice for surgeries. The product, adopting a shrink-formed box and dialyzing paper as primary packaging, is EO-sterilized with a residual EO content of 10ug/g or lower.

2 Technical Parameters

Titanium clips are divided into two categories. One is the titanium clips without titanium clip applicator, this kind of titanium clips have four specifications, 1# clips have a max. ligation width of 4mm, 2# clips have a max. ligation width of 5mm, 3# clips have a max. ligation width of 7mm, and 4# clips have a max. ligation width of 10mm.The other is titanium clips with titanium clip applicator, this kind of titanium clips with titanium clip applicator have a max ligation width of 6mm. A Titanium Clip applicator is primarily made up of the surgical head, stem, turning wheel and handle.

3 Packaging

3.1 The number of a minimum clip package is 6 clips/cartridge. The number of a medium package of 1#,2#,3# and 4# clips is 20 cartridges (or 120 clips)/box.

3.2 A minimum package is including a Titanium Clip applicator equipped with 16 clips. Primary packaging consists of shrink-formed boxes and dialyzing paper.

4 Product Photo, Specification and Size

REF	B	H	L1	L2	Max. Ligation Width
1#	0.5±0.1	0.35±0.1	5.9±1	2.2±1	4
2#	0.75±0.1	0.50±0.1	8.7±1	3.2±1	5
3#	0.97±0.1	0.61±0.1	14.5±1	5.1±1	7
4#	1.16±0.1	0.84±0.1	18±1	8.3±1	10
Applicator	0.8±0.1	0.6±0.1	5.6±1	8.0±1	6

5 Shelf Life

The shelf life of the product is three years. It is sterilized by ETO and for single use only. The valid period of sterile condition maintaining is as the shelf life.

6 Declaration

The plastic parts of this device don't contain DEHPs or latex.

7 Usage

7.1 Usage of a Titanium Clip applicator

7.1.1 Hold the handle of the applicator such that the surgical head part fully.

7.1.2 Position the surgical head such that it is perpendicular to the titanium clip box. Fix the clip firmly to the surgical head and then pick the clip out of the box. Check that the handle is not closed.

7.1.3 Check if the clip is completely fitted into the surgical head in a firm and secure way.

7.1.4 Feed the clip into the location of the patient's body where ligation is needed.

7.1.5 Position the location of the patient's body where ligation is needed. Close the handle in a precise single effort until the clip is fully closed. Then loosen and withdraw the applicator from the patient's body.

7.2 Usage of Titanium Clip applicator

7.2.1 Hold the handle of the applicator such that the surgical head part fully.

7.2.2 Close the handle and the clip will be automatically shifted from the stem to the surgical head.

7.2.3 Check if the clip is completely fitted to the surgical head in a firm and secure way.

7.2.4 Feed the clip into the location of the patient's body where ligation is needed.

7.2.5 Position the location of the patient's body where ligation is needed. Close the handle in a precise, continuous effort until the clip is fully closed. Then loosen and withdraw the applicator (at this point, the second clip has already been shifted to the head).

7.2.6 If continuous ligations are needed, close the handle once again. Otherwise, the applicator should be withdrawn from the patient's body.

7.3 Surgical Procedure

The product shall be used according to the method given by the trainer.

8 Indication

Cholecystotomy, colectomy, proctectomy, splenectomy, gastrectomy, appendectomy, hepatectomy,nephrectomy, adrenalectomy, kidney cyst excision, salpingectomy, ovariectomy, hysterectomy, thymoma excision, bulla excision, pulmonary lobectomy, etc.

9 Contraindication

Not indicated for tubal ligation for contraception purposes or renal artery ligation in nephrectomy.

10 Warnings

10.1The device is sterilized by ethylene oxide gas, so it can be directly used after unpacked.

10.2 The device is designed for single use only.

10.3 Do not use if package is damaged.

10.4 Do not use the device after the expiry date of three years.

10.5 Do not resterilize the device.

11 Cautions

11.1 Prior to use, carefully read all package insert warnings, precautions and instructions.

11.2 The operators using the product shall be trained professionally.

11.3 Failure to follow the instruction may result in severe patient injury or death.

11.4 The suitable clip shall be selected before use on the basis of the tissue size and the conditions of the blood vessels.

11.5 The product shall be kept away from sunlight, rats, fire, insects and stored in a clean, non-corrosive gases and well-ventilated place. The storage temperature shall be -5ºC~40ºC and relative humidity be 10%~80%.

11.6 Before using the device, please check the parts to be inserted into human body to make sure the surface is smooth, without sharp edges or burs which possibly cause safety damage.

11.7 Disposing the device must conform to the regulations of medical wastes.