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恒诺一次性使用无菌阴道扩张器
发布时间:2019/6/3 9:27:05  编辑:ahhuike   浏览次数:826次

        

             

  

             多项专利保护 医保收费耗材           

 

  恒诺一次性使用无菌阴道扩张器临床应用:妇科常规检查、体检中心病症筛查;宫颈、阴道、外阴等病变的观察;荧光检查、宫颈癌及癌前病变早期筛查和术后复查。产品获得国家发明专利技术保护,产品质量和疗效得到双重保障。

 

  优势1:全新产品,提高疾病诊断准确率,光源和一次性阴道扩张器的完美结合。

  内置光源,高照度,高显色性,防眩光;让医生看得清、看得真、看得准。


  优势2:便捷性好,准确率高,适用不同场合,如转院、病床上不宜移动患者、医院外及没有电源及光源情况下使用。

 

  荧光检查,减少宫颈病变的漏诊、误诊、延诊。弥补宫颈片的高漏诊率及阴道镜检查耗时长、器械笨重劣势。

 

说明书:

【产品名称】一次性使用无菌阴道扩张器

【商品名称】恒诺

【适用范围】供妇科检查时使用

【使用说明】

1、使用本产品前应首先注意包装、生产批号和失效年月。

2、使用时打开密封包装,将阴道扩张器上、下叶闭合,轻轻送入阴道内,打开扩张器进行检查。

3、使用后按医疗垃圾交于专业人员进行处理。

4、可以与外置或内置光源配合使用。

【规格型号】分为Ⅰ型和II型   

【禁忌症】

【注意事项】

1、本品已经无菌处理,若包装破损请勿使用。

2、本品开启后一次性使用,用后销毁。

3、生产批号和失效年月见外包装袋。

4、应置放于儿童触及不到的地方。

【贮存条件】通风干燥处常温保存,避免阳光直射。

【医疗器械注册证编号】皖械注准20182660003

【医疗器械生产许可证编号】皖食药监械生产许20180040号

【申请人/生产企业】安徽徽科生物工程技术有限公司

【电话】0558-8376688

全国统一咨询电话:4008887208

    

Application:
*Gynecological common examination
*Disease screening in physical examination center
*Observation of cervix uteri lesions, vagina lesions and vulva lesions
*Fluoroscopy
*Early screening and postoperative examination of cervical cancer and precancerous lesions.
*Multiple patents are protected, the product is included in the scope of medical insurance

Advantage:
1.Brand new product, improve accuracy of disease diagnosis. Perfect combination of light and disposable sterile vaginal expander.
Built-in light, high illuminance, high color rendering, anti-dazzle, doctors can see clearly, truly and accurately.

2.Convenient, high accuracy, suitable for different occasions, for example transfer to another hospital, not suitable to move patients on bed, outside of hospital and no light or no power source etc.
Fluoroscopy, reduce missed diagnosis, misdiagnosis and delayed diagnosis of cervical lesions, make up high missed diagnosis of cervical film, and long time-consuming and shortage of heavy instrument of cervical film.


We pass ISO13485 & CE international quality management system certifications.

Specification:
Product Name:  Disposable Sterile Vaginal Expander
Product Application:  Used For Gynecologic Examination.

Direction:
1.Before using, please pay attention to the package, batch no. and expiry date.
2.Open the sealed package, close upper vane and lower vane, put into vagina, then open expander to examine.
3.After using, hand over to professionals to deal with.
4.It can be co-used with external or internal light source

Model:  Type I: with LED light source.
 Type II:  without an LED light source

Contraindication: No

Notice
*The product is asepsis, please don’t use when package is broken.
*The product is disposable, and should be destroyed after using.
*Batch no. and expiry date are marked at the seal.
*Please store it out of children’s reach.

Storage condition: Normal temperature and dry place storage, avoid exposing to sunshine directly.

Validity: 24 months

Medical Device Registration Certificate Number:  20182660003 issued by Anhui Food and Drug Administration
Medical Device Production Permit Number:  20180040
Registrant Name:  Anhui Huike Bio-engineering Technology Co., Ltd.
Production Address: A Area, Economic Development Zone, Taihe County , Anhui Province,China
Postal Code:  236600
Tel.:  0558-8376688
Fax:  0558-8696288

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