一次性使用帶貼輸液器 帶針產品說明:

注冊證編號：國食藥監(jiān)械（準）字2010第3660423號

產品結構：一次性使用帶貼輸液器 帶針產品是由一次性使用輸液器帶針和醫(yī)用輸液貼組成，只在一次性使用輸液器帶針的產品中包中添加了單獨包裝的醫(yī)用輸液貼。一次性使用輸液器帶針是由穿刺器保護套、穿刺器、進氣器件（或空氣過濾器）、滴管、滴斗、管路、流量調節(jié)器、藥液過濾器、乳膠管（根據(jù)合同要求）、一次性使用靜脈輸液針組成。一次性使用靜脈輸液針由保護套、針管、針柄、軟管、針座組成。

Disposable infusion sets with application with needle consist of disposable infusion set with needle and medical infusion set application, only the disposable transfusion（with needle）there’s additional sole packed medical application. The disposable infusion set （with needle） consist of protective cover of the spike, spike, air vent parts （or air filter）, drip tube, drip chamber, tube, flow rate regulator, liquid medicine filter, latex cover （according to the request of the contact）, disposable IV infusion set needle. The disposable IV infusion set needle consist of protective cover, needle tube, needle handle, flexible tube, needle seat.

產品用途：供醫(yī)護人員靜脈輸液時使用。For medics IV transfusion using.

產品型號Model:

A1、A2、A3、A4、A5、A6、A7、A8；

輸液針I(yè)nfusion set Needle:

0.45mm、0.55mm、0.6mm、0.7mm、0.8mm、0.9mm

產品標準：YZB/國0090-2010《一次性使用帶貼輸液器 帶針》

產品特點：

1.本品采用醫(yī)用高分子材料制造，經環(huán)氧乙烷氣體滅菌、無菌、無熱原、無溶血反應、無急性全身毒性。

The products are made of medical high polymer, steriled by EO-gas,sterile, non-progeny, non-hymolysis, no acute systemic toxicity.

2、輸液器液體通道各組件的連接，不包括保護套，應承受不小于15N的靜拉力，持續(xù)15S。

The joint of every part of the liquid channel in the infusion set, exclude the protective cover, should be support not less than 15N static pull, keep 15seconds.

3、由軟質材料制成的軟管塑化均勻，足夠透明。當有氣泡通過時，用正?；虺C正視力可以發(fā)現(xiàn)水和空氣的分界面。The flexible tube made of soft material should be plasticized evenly, transparent enough. The interface of the water and air could be seen under normal or rectified vision when air bubble passing.

4、軟管壁厚不小于0.39mm，外徑不小于3.65mm，輸液器全長大于等于1600mm。

The flexible tube wall thickness is not short than 0.39mm, the outer diameter is not short than 3.65mm, the total length of the transfusion apparatus is equal or longer than 1600mm.

5、滴斗：平均壁厚≥0.5mm；外體積≥10cm3

Drip chamber: The average wall thickness is equal or thicker than 0.50mm; outer volume is equal or larger than 10cm3

6、藥液過濾器濾除率不小于80%。

The filtering rate of the liquid medicine filter is not less than 80%

7、空過：對空氣中0.5vm以上微粒的濾出率≥ 90%，流量降低≤ 20%

Air vent and filter: To the 0.5um or above particle in the air, the filtering rate is equal or bigger than 90%, flow rate reducing is equal or less than 20%.

一次性使用帶貼輸液器 帶針產品是由一次性使用輸液器帶針和醫(yī)用輸液貼組成，只在一次性使用輸液器帶針的產品中包中添加了單獨包裝的醫(yī)用輸液貼。一次性使用輸液器帶針是由穿刺器保護套、穿刺器、進氣器件（或空氣過濾器）、滴管、滴斗、管路、流量調節(jié)器、藥液過濾器、乳膠管（根據(jù)合同要求）、一次性使用靜脈輸液針組成。一次性使用靜脈輸液針由保護套、針管、針柄、軟管、針座組成。