牙科修整用陶瓷车针使用说明书

牙科修整用陶瓷车针使用说明书

Instruction of Zirconia Ceramic Lab Burs

【产品名称】牙科修整用陶瓷车针

Name: Zirconia Ceramic Lab Burs

【型号规格】型号：牙科修整用整体陶瓷车针，牙科修整用粘接陶瓷车针。规格详见“牙科修整用陶瓷车针型号规格列表”。

Model and specification: Please find details from “Model and Specification List of Zirconia Ceramic Lab Burs”.

【适用范围】配合牙科手机使用，用于口腔中牙齿、骨、修复体等硬质结构的抛光、打磨操作。

Application area: It can be used with dental handpieces to grind and polish hard structures such as

 teeth, bones and restorations in oral cavity.

【组成结构】由工作部分和柄部组成。工作部分是由氧化锆陶瓷制成，柄部是硬质合金或不锈钢材料或氧化锆陶瓷制成。使用时安装于手机，由手机驱动旋转。非无菌提供。使用前由使用机构根据说明书进行灭菌。

Structure: The product consists of a working part and a shank. Its working part is made of zirconia ceramic, and the handle is made of tungsten carbide, stainless steel, or zirconia ceramic. And the product is driven by a handpiece to rotate for use. Prior to use, the non-sterile product needs for sterilization by the user according to the instruction. 

【使用方法】本产品与牙科手机连接使用，每次使用时请预先进行运转检查。若发觉有松动、摆动等异常现象，请立即停止使用，并与原经销商联系。

Usage method: The product is used in conjunction with the dental handpiece. Please check the

operation in advance each time before use. If loosening, swinging or other abnormal phenomenon is 

found, please stop using immediately and contact the original dealer.

【禁忌事项】无。

Contraindications: None.

【注意事项】1.使用前确认产品包装完整性。

Cautions:      1. Confirm the integrity of product packaging before use.

                       2.使用前请仔细检查产品，如发现产品有任何损坏或变形都请停止使用。

2. Check products before use. If you find any damage or deformation of the product, please stop using it.

                        3.使用前请佩戴防护眼镜和噪音耳塞。

3. Wear eye-protective safety glasses and sound insulation earmuffs before use.

                       4.使用后请及时清洁，并保持车针干燥。

4. Disinfect and clean burs in time after use. Keep them dry. 

                       5.当发现车针磨损不锋利或车针切削力降低时请及时更换。

5. Please replace the burs in time if they are not sharp.

                        6.牙齿经过打磨、抛光后必须经过清洗消毒方可使用。

6. After the teeth are ground or polished, they must be cleaned and disinfected before use.

【贮   藏】车针应储存在干燥、稳定（无摔碰）、远离酸碱等有害化学物质及气体的洁净的常温、常压、湿度小于 90%的环境中。

Storage: The product should be stored in a dry, stable environment (without falling and touching) at normal temperature and pressure, and humidity of less than 90%, away from acid, alkali and other harmful chemicals and gases. 

【有效 期】10年

Expiry date: 10 years

【灭菌方式】

本产品经过清洗后包装，但未经灭菌处理，在包装完好以及未受污染情况下无需清洗，直接进行灭菌处理后使用。灭菌前，先取出所有的包装材料。在手术区之内使用经过灭菌的产品。

建议使用下列处理参数由医院进行湿热灭菌。

Sterilization method:

The non-sterilized product is packaged after cleaning. If its package is intact and not contaminated, it does not need to be cleaned, but directly sterilized and put into use. Please remove all packaging materials before sterilization. And the sterilized product should be used within the surgical area.

It is recommended that hospitals should adopt the moist heat sterilization method according to the following processing parameters.

【运      输】需按原厂包装运输，运输时按包装上标识所示摆放，勿重物挤压。

Transportation: The products need to be stored in the original packaging and be placed

according to the labels on the packaging during transportation. Do not squeeze.

【生产企业】惠而顺（上海）医疗器械有限公司

Manufacturer: WILSON (Shanghai) Medical Device Co., Ltd.

【住  所】上海市宝山区真陈路 868 号 4幢一层、5 幢

Address: Floor 1, Building 4, and Building 5, No.868 Zhenchen Road, Baoshan District, Shanghai

【生产地址】上海市宝山区真陈路868号8幢1层A区，3幢1层B区

Place of Production: Area A, Floor 1, Building 8, and Area B, Floor 1, Building 3, No.868 Zhenchen Road, Baoshan District, Shanghai

【联系方式】021-36162006

Tel: 0086-21-36162006

【售后服务单位】惠而顺（上海）医疗器械有限公司

After-sales Department: WILSON (Shanghai) Medical Device Co., Ltd.

【产品备案凭证编号】沪宝械备20240066

Product Record Certificate Number: No.HBXB20240066

/Hu Bao Medical Product Record No.20240066

【生产备案凭证编号】沪宝药监械生产备20212353号

Production Record Certificate Number: No.HBYJXSCB20212353

/Hu Bao Medical Products Administration Product Record No.20212353

【说明书编制日期】2024 年 11月 27 日

 Preparation date of instruction: 2024/11/27