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多項專利保護 醫保收費耗材
恒諾一次性使用無菌陰道擴張器臨床應用：婦科常規檢查、體檢中心病癥篩查；宮頸、陰道、外陰等病變的觀察；熒光檢查、宮頸癌及癌前病變早期篩查和術后復查。產品獲得國家發明專利技術保護，產品質量和療效得到雙重保障。
優勢1：全新產品，提高疾病診斷準確率，光源和一次性陰道擴張器的完美結合。
內置光源，高照度，高顯色性，防眩光；讓醫生看得清、看得真、看得準。
優勢2：便捷性好，準確率高，適用不同場合，如轉院、病床上不宜移動患者、醫院外及沒有電源及光源情況下使用。
熒光檢查，減少宮頸病變的漏診、誤診、延診。彌補宮頸片的高漏診率及陰道鏡檢查耗時長、器械笨重劣勢。
說明書：
【產品名稱】一次性使用無菌陰道擴張器
【商品名稱】恒諾
【適用范圍】供婦科檢查時使用
【使用說明】
1、使用本產品前應首先注意包裝、生產批號和失效年月。
2、使用時打開密封包裝，將陰道擴張器上、下葉閉合，輕輕送入陰道內，打開擴張器進行檢查。
3、使用后按醫療垃圾交于專業人員進行處理。
4、可以與外置或內置光源配合使用。
【規格型號】分為Ⅰ型和II型
【禁忌癥】無
【注意事項】
1、本品已經無菌處理，若包裝破損請勿使用。
2、本品開啟后一次性使用，用后銷毀。
3、生產批號和失效年月見外包裝袋。
4、應置放于兒童觸及不到的地方。
【貯存條件】通風干燥處常溫保存，避免陽光直射。
【醫療器械注冊證編號】皖械注準20182660003
【醫療器械生產許可證編號】皖食藥監械生產許20180040號
【申請人/生產企業】安徽徽科生物工程技術有限公司
【電話】0558-8376688
全國統一咨詢電話：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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