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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.
啄木鸟弯手机 (型号: CA161、CA161-RR) 是一种符合 ISO 7785-2 标准的齿轮
角手机，用于固定和驱动旋转器械以进行旋转加工，用于牙髓治疗。
Remark: The figure below is schematic diagram.Differences between different models
in the table 1-1,The components in the table 1-2 and attachments in the table 1-3 are
sold together with the device. 备注：下图为示意图。表1-1中不同型号的区别，表
1-2中的组件和表1-3中的附件与设备一起销售。
桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司
GUILIN WOODPECKER Medical Instrument Co.,LTD.
产品描述
Product Description
Figure 1 Structure of CA161
File No.：ZMN-YF-BK10-01-001-001-1
Version：A
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Summary of Contents for Woodpecker CA161
- Page 1 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.
- Page 2 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...
- Page 3 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...
- Page 4 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.
- Page 5 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.
- Page 6 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...
- Page 7 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...
- Page 8 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 Atmospheric pressure: 70kPa ~ 106kPaf 7.3 Device safety classification Degree of protection against harmful ingress of water: Ordinary equipment (IPX0).
- Page 9 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...
- Page 10 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...
- Page 11 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℃);...
- Page 12 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.
- Page 13 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...
- Page 14 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;...
- Page 15 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.
- Page 16 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).
- Page 17 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 20.Conformity assessment procedure Annex IX, (EU) 2017/745, MDR 21.EU Representative Name：MedNet EC-Rep GmbH Add: Borkstrasse 10 ,48163 Muenster ,Germany...
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