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医用外科口罩(无菌型) 医用外科口罩(无菌型)

医用外科口罩(无菌型)

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医用外科口罩(无菌型)产品说明书
 
【产品名称】 医用外科口罩(无菌型)
【型号/规格】型号为:A1(平面形耳挂式);规格分为:XL(19cm×18cm);L(17cm×16cm);M(15cm×14cm);S(13cm×12cm);XS(11cm×10cm)。具体产品的型号/规格详见标签。
【结构组成】产品由口罩体、鼻夹、口罩带组成。外层为无纺布,中间层为熔喷无纺布,鼻夹由可
弯折的聚丙烯材料制成,口罩带由松紧带制成。经环氧乙烷灭菌,产品无菌供应。
【适用范围】适用于医务人员或相关人员(成人)的基本防护,以及在有创操作过程中阻止体液和喷溅物传播的防护。
【产品性能】符合YY/0469-2011标准的要求。
【注册人/生产企业名称】长沙邦创生物科技有限公司
【生产地址】浏阳经济技术开发区康万路188号汉元孵化园A栋二楼
【注册人/生产企业住所】浏阳经济技术开发区康万路188号汉元孵化园A栋二楼
【注册人/生产企业联系方式】400-666-5548
【售后服务单位】长沙邦创生物科技有限公司
【生产许可证编号】湘食药监械生产许20150038号
【注册证编号/产品技术要求编号】湘械注准20202140355
【禁忌症】暂无
【注意事项、警示以及提示的内容】
1. 灭菌产品有效期为一年,请确认有效期后使用,包装破损严禁使用。
2. 本品为一次性使用产品,严禁重复使用,用后销毁。
3. 灭菌产品开封后应立即使用;连续使用时均应及时更换,单次佩带时间不应超过4小时。
4. 心肺功能异常者谨慎使用。
【使用说明】
1. 口罩取出后,将有鼻夹定型件的部分朝上,使口罩覆盖鼻、口和下颌部位。
2. 各种形状口罩展开后均为凹面朝里,凸面朝外,如为双色口罩则可按深色朝外,浅色朝里区分里外;
3. 戴好耳带,捏紧鼻夹,使其紧贴鼻梁和面部。
【贮存方法】应保证包装完好,避免潮湿和高温,在室内无腐蚀性气体、通风良好的自然条件下贮存。
【生产批号】详见标签
【生产日期】详见标签
【有效期限】一年

【标签所用的图形、符号、缩写等内容的解释】

【说明书修订日期】本说明书修订日期为2020年3月6日。


Surgical Mask (Sterile)
【Product Name】Surgical Mask(Sterile)
【Type/Specification】Type:A1(planar ear-loop style);Specifications: XL(19cm×18cm);
L(17cm×16cm);M(15cm×14cm);S(13cm×12cm);XS(11cm×10cm). Please refer to the label for details.
【Composition】The mask is composed of the mask body, nose bridge clip and ear loops. The outer and inner layers are made of non-woven fabrics and the middle layer with polypropylene melt-blown fabric. the clip made of bendable polypropylene material .The ear loops are with elastic material.  It is in sterile state after being sterilized with ethylene oxide
【Scope of Application】To provide basic protection for medical personnel and offer protection to against the spread of body fluids and spillage when working in invasive operation
【Product Performance】It conforms to the requirement of standard YY/0469-2011
【Registrant/Manufacturer】Changsha Biostrong Technology Co., Ltd.
【Manufacturing Address】Floor 2,Building A, Hanyuan Incubator Garden,188 Kangwan Rd,
Liuyang Economic and Technological Development Zone, Changsha, Hunan Province
【Registrant/Manufacturer Address】Floor 2,Building A, Hanyuan Incubator Garden,188 Kangwan Rd, Liuyang Economic and Technological Development Zone, Changsha, Hunan Province
【Contact Number】400-666-5548
【After-sales service Provider】Changsha Biostrong Technology Co., Ltd.
【Manufacturing License(s)】:湘食药监械生产许20150038号
【Registration Certificate No./Technical Requirement No.】湘械注准20202140355
【Contraindication】No data available.
【Warning】
1.The validity period of this sterilized product is one year, Please confirm the date before use it. It is strictly prohibited to use when the package is damaged .
2. The sterile product is one-time use only. Repeated use is not allowed. Destroy it after use. 
3. Use immediately after the package opened. Continuous use should not exceed for 4 hours.  
4.Use with caution for those weak in heart and lungs. 
【Direction for Use】
1. Take out the mask and upward the nose bridge clip make sure the mask completely cover the nose, mouth and chin. 
2.The concave side should face inwards, and the convex side outwards. For a two-color mask, the dark color side should face outwards, and the light side inwards;
3.Place the ear loops around ears, pinch the nose clip to let it fit your nose and face
【Storage Condition】The package should remain intact, kept away from humidity and high temperature, and stored indoor with good ventilation facilities and no corrosive gases
【Batch Number】Refer to label for details.
【Manufacturing Date】Refer to label for details. 
【Validity Period】1 Year. 
【Interpretation of graphics, symbols, abbreviations, etc. used in labels】

 【Revision Date】The manual is updated on March 6, 2020

400-666-5548
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