0.3ml Retractable safety syringe auto-disable syringe AD syringe safe

Features:

High transparent pp provides clear graduation visibility.

Full automation assemble line makes mass production easily.

The patented safety mechanism is an integrated part of the syringe without add-on pieces.

Tab at the end prevents pre-activation during transportation or before injection.

Benefits:

Clinicians’ hands and fingers remain behind the sharp at all times

Minimal dead space, Minimize waste in medication

The needle is securely protected inside the barrel and remains protective during disposal.

No Recapping required.

Largely save on disposal cost

Usage instruction:

1,Remove the needle cover

2,Draw up medication as per protocol

3,Remove the confining piece

4,Remove air bubbles

5,Push the plunger to inject and lock the needle when medication finished

6,Withdraw the plunger to draw back the needle into the barrel

7,Break off the plunger

8,The syringe has been totally disabled

1 Introduction of the company

1.1 Overview of the company

The reformation of international and domestic medical device for single use market is coming. The R&D team established the “single Use Medical Device Improvement Institute” in Shanghai in ***0, which mainly focus on R&D and improvement of single use medical devices. In ***3, the first product “TS-ARetractable Safety Syringe Single Use Only” with patent was completed， and the patent application was submitted to National Intellectual Asset Bureau.

    To hold the coming of domestic and international market opportunity,Classic Medical Tech (SHA) Co., Ltd. was established in Dec. of ***3. The personnel include personnel of original R&D personnel of Jinyue Institute, specialists from various scope, including overseas personnel back to China, nurses, R&D management personnel more than *0 persons. Other than strong R&D force, the company has the stage planning for new product marketing, the objective is holding a certain market share in 2 years.

The products in marketing of our company will all have independent intellectual asset. This plentiful immateriality asset will be the first backbone of our company to enter the capital market in the future.

The quality policy of our company is：

“Accurate and fine, scientific and creative”

The quality objective of our company is：

â‘  Establish a perfect quality management system，effectively implement and continually improve，ensure the certification of ISO ****5:***3《Medical devices — Quality managementsystems — Requirements for regulatorypurposes》 and 《Medical Device Directive of EC》（ *3/*2/EEC:***3）.

â‘¡ Take the 6σ as quality management measure, pursue the best level of internationalï¼›quality level achieves 3σ in 1 year.

â‘¢ The product quality conforming to national requirement, and the conformity rate in inspection for delivery achieve **0%.

1．2 The company

Address:Room **-D,No.2,Lane **0,TianShan Road, ChangNing District, ShangHai, Chin

Postal code：*****5   Tel：*************1    Fax：*************1

1．3 EC-representative

Name of EC-representative：Eastland Medical System PLC

Address of EC-representative：Suite 9, The Royal *5 Bank Plain， Norwich，Norfolk， NR*4SF，United Kingdom

Tel： *4 (***3) **3 **9

Fax： **4 (***3) **6 **9

2 Description of the product

2.1 Description of the product

The syringe for single use is a common product widely used in domestic and international medical units. The Retractable Safety Syringe Single Use Only manufactured by our company use same raw materials with common syringe for single use, it is not a completely new product, it just improves the exist product and adds the safety and self-destroy function after injection.

2.2 Components of the product

The components of product include coat, needle tube, needle stand, protective coat and piston.

2.3 Intended use of the product

The Retractable Safety Syringe Single Use Only is used for clinical injection for sufferer. The injection process is very same as traditional syringe, the difference is after injection, the needle tube is retractable to ensure single use and prevent cross infection in injection.

3 Pattern of the product （see Fig. 1）

1—zero scale lineï¼›2—sub-scale volume lineï¼›3—nominal volume scale lineï¼›4—general volume scale lineï¼›5—base lineï¼›6—coat roll edge; 7—needle tubeï¼›8—coat neckï¼›

9—needle standï¼›*0—coatï¼›*1—stick headï¼›*2—metallic hookï¼›*3—pistonï¼›*4—stickï¼›*5—handleï¼›*6—coatï¼›*7—protective piece

Note：This sketch map is only for illustrating structure of syringe，not indicate the only pattern specified by standard.

Fig. 1 Retractable Safety Syringe Single Use Only

 

4 Performance of the product

4.1 The Retractable Safety Syringe Single Use Only is improved based on traditional syringe for single use.

4.1.1 There added a stick head on stick part, and assembly a metallic hook.

4.1.2 The match of needle stand and coat was changed from assembly inside to assembly outside.

4.1.3 There is break fracture and protective piece.

4.2 The raw materials and production technique is basically same as traditional syringe for single use.

4.3 Performance other than safety and self-destroy please refer to ISO *****1：***3/ GB ****0—***1《Sterile Syringe for Single Use》和ISO ***4：***3/ GB ****1—***1《Sterile Syringe Needle for Single Use》.

4.4 The structure and safety and self-destroy function of Retractable Safety Syringe Single Use Only refers the needle stand assembled in inside of coat neck. After injection, the metallic hook on head of stick inserts the needle stand, the stick will lock with needle stand which causes destroy, pull back the stick at that time, the needle tube will retract to coat completely, which achieves safety function.

5   Precautions in use of the product

5.1 Use before expiry date. Use after expiry date is forbiddenï¼›

5.2 Check if there is foreign substrates in unit package before use. Do not use if there is foreign substrateï¼›

5.3 For single use only. Use immediately after unit package openedï¼›

5.4 Do not use if package is broken.

5.4 Do not use if there is other abnormal issues.

5.5  Store the product with conditions of humidity not more than *0%，temperature not higher than *0℃，no erosive gas and with good aeration. The humidity-proofing and disinfection-proofing shall be considered.

6 Specifications of the product

There are 8 specifications of Retractable Safety Syringe Single Use Only: 0.1ml,0.3ml,0.5ml, 1ml,2ml, 3ml, 5ml, *0ml.

7 Accessories and package of the product

Each Retractable Safety Syringe Single Use Only is packaged in a unit package. Each **0～**0 unit packages are put in middle package, and each 6～8 middle packages are put in outer package because of the limitation of size.

8 Classification of the product

According to classification rule of 《Medical Device Directives》（*3/*2/EEC:***3）, the Retractable Safety Syringe Single Use Only manufactured by our company is classified as Class Ⅱa product.

9 Conformity routine of the product

Select the certification routine according to 《Medical Device Directives》（*3/*2/EEC:***3）Annex II.