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Product Description 1. Device Composition 设备组成 Woodpecker Contra-angle handpiece (model: CA161、CA161-RR) is a kind of geared angle handpiece according to ISO 7785-2 and is use to hold and drive rotary instruments for the purposes of rotary processing, intended for the endodontic treatment.
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桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司 GUILIN WOODPECKER Medical Instrument Co.,LTD. File No.:ZMN-YF-BK10-01-001-001-1 Version:A Figure 3 Structure of CA161-RR Table 1-1 Differences between different models Model CA161 CA161-RR Output Speed Range 100~1200 rpm 100~2500 rpm 输出速度范围...
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桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司 GUILIN WOODPECKER Medical Instrument Co.,LTD. File No.:ZMN-YF-BK10-01-001-001-1 Version:A Maximum overall 46mm length of the rotary instrument Table 1-2 Description of main part of Contra-angle handpiece Model Configuration 配置...
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桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司 GUILIN WOODPECKER Medical Instrument Co.,LTD. File No.:ZMN-YF-BK10-01-001-001-1 Version:A 2 Intended Use, User and Patient 2.1 Intended use: The Contra- angle Handpieces are used to clamp rotating instruments such as burs, dental drills, and dental files, and drive their movements to realize dental operations such as cutting, grinding and drilling.
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桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司 GUILIN WOODPECKER Medical Instrument Co.,LTD. File No.:ZMN-YF-BK10-01-001-001-1 Version:A use this equipment; 4) Patients with oral and maxillofacial infections, various types of oral mucosal diseases that have not been cured, periapical disease, gingivitis, periodontal disease and oral cancer are forbidden to use this equipment.
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桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司 GUILIN WOODPECKER Medical Instrument Co.,LTD. File No.:ZMN-YF-BK10-01-001-001-1 Version:A 6) Please keep the shanks/files handle clean. Otherwise, the stains on the surface of handle will affect the correct fixation of shanks/files, causing the shanks/files to fly out during operation;请保持柄/锉柄清洁。否则,手柄表...
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桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司 GUILIN WOODPECKER Medical Instrument Co.,LTD. File No.:ZMN-YF-BK10-01-001-001-1 Version:A the third parties.使用不当会损坏本产品, 进而伤害患者、 使用者和第三方。 7.Specification 7.1 Specification of main unit Table 1-1 Differences between different models Model...
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桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司 GUILIN WOODPECKER Medical Instrument Co.,LTD. File No.:ZMN-YF-BK10-01-001-001-1 Version:A Noise 噪音 The A-weighted sound pressure level generated by the handpiece shall not exceed 80 dB. 手机产生的 A 计权声压级不得...
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桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司 GUILIN WOODPECKER Medical Instrument Co.,LTD. File No.:ZMN-YF-BK10-01-001-001-1 Version:A Preparation for The products must be reprocessed in a disassembled state.产品必须在拆卸状 reprocessing 态下进行再加工。 Tools: tray, soft brush, clean and dry soft cloth Pre-cleaning 预清...
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桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司 GUILIN WOODPECKER Medical Instrument Co.,LTD. File No.:ZMN-YF-BK10-01-001-001-1 Version:A Emptying • 3 min neutralizing with warm water(>40℃); • Emptying • 5 min intermediate rinsing with warm water(>40℃);...
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桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司 GUILIN WOODPECKER Medical Instrument Co.,LTD. File No.:ZMN-YF-BK10-01-001-001-1 Version:A 2).The air used for drying must be filtered by HEPA. The device should be dried in a clean area.
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桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司 GUILIN WOODPECKER Medical Instrument Co.,LTD. File No.:ZMN-YF-BK10-01-001-001-1 Version:A ensure cleanliness and prevent the introduction of contaminants; Avoid contact with different metals when packaging. Sterilization of instruments by applying a fractionated pre-vacuum...
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CE mark under MDR, hence, there is no information reference to previous and similar generations of the device. 14.Statement Guilin Woodpecker Medical Instrument Co., Ltd. is not use of and will not use of the following materials to manufacture the Contra-angle handpiece: derivatives of tissues or cells of human origin;...
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桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司 GUILIN WOODPECKER Medical Instrument Co.,LTD. File No.:ZMN-YF-BK10-01-001-001-1 Version:A mucosa oral口 腔黏膜、完整 皮肤 16.Disposal When disposing of this equipment, or any of its components (such as fuses), follow all applicable national and local laws and guidelines.
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桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司 GUILIN WOODPECKER Medical Instrument Co.,LTD. File No.:ZMN-YF-BK10-01-001-001-1 Version:A 18.Classification 分类 The device is classified as IIa according to Rule 9 in Annex VIII of MDR (2017/745).
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