Woodpecker CA161 Product Description Download 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

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. It shall be disposed according to the
cleaning, disinfection and sterilization methods recommended in the manual before
being discarded.

在处理本设备或其任何部件(如保险丝)时,应遵循所有适用的

国家和地方法律和准则。在丢弃前,应按照手册中推荐的清洗、消毒、灭菌方法

进行处理。

17.GMDN Code

Code: 38347
Definition: A hand-held, mains electricity (AC-powered) dental device that includes a
chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade,
polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and
tough tissues. It is powered by a low-voltage electric micro-motor (e.g., 24 volt) that
is an integral part of the device; the endpiece(s) are not included. It is typically
connected through the dental delivery system or a freestanding independent control
unit. This is a reusable device.

代码:

38347

定义:手持电力(

AC

动力)牙科设备,其中包括用于连接牙科端件(例如,钻

头,钻头,铰刀,铰刀,锯子,锯刀,抛光盘)的

Chuck

collet

,旨在用于牙科

牙科 钻孔

/

挖掘骨骼,牙齿和坚硬的组织。 它由低压电动运动器(例如

24

伏)

提供动力,该电机是设备的组成部分。 端件不包括。 它通常通过牙科输送系统
或独立独立控制单元连接。 这是可重复使用的设备。

Summary of Contents for CA161

Page 1: ...ece 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 CA161 CA161 RR ISO 7785 2 Remark The figure belo...

Page 2: ...200 rpm 100 2500 rpm Output Torque Range 0 4 5 0 Ncm 0 6 4 2 Ncm Chuck type Push button Gear ratio 6 1 Rotation mode Continuous forward continuous reverse and reciprocating rotation Continuous forward...

Page 3: ...1 Type1 3 CA161 RR 1 Gear ratio 6 1 2 Output Speed Range 100 2500 rpm 3 Output Torque Range 0 6 4 2 N cm 4 Chuck type Push button 5 File shank attachment 2 35mm ISO1797 1 Type1 Table 1 3 Description o...

Page 4: ...2 3 Intended patient Patients who need root canal treatment 3 Operation Principle The Contra angle handpiece is a kind of geared angle handpiece and is use to hold and drive rotary instruments for th...

Page 5: ...ematopoietic system digestive system and endocrine system should be cautious to use this equipment 8 Pregnant women lactating women or women of childbearing age who have a plan of pregnancy should be...

Page 6: ...h force to treatment site 11 Please carry out regular maintenance and inspection 12 If the Contra angle Handpieces has not been used for a period of time before operation please maintain it as per mai...

Page 7: ...Output Speed Range 100 1200 rpm 100 2500 rpm Output Torque Range 0 4 5 0 Ncm 0 6 4 2 Ncm Chuck type Push button Gear ratio 6 1 Rotation mode Continuous forward continuous reverse and reciprocating ro...

Page 8: ...the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide 8 Performance Item Technical requirement Appearance and Structure 1 The outer surface should be flat smooth and tidy wit...

Page 9: ...ece could be capable of being subjected to 250 cycles of sterilizing procedure 250 Preparation at the Point of Use The post operative process must be carried out immediately no later than 30 minutes a...

Page 10: ...nd be difficult to remove 10 40 Cleaning Regarding cleaning disinfection rinsing and drying it is to distinguish between manual and automated reprocessing methods Preference is to be given to automate...

Page 11: ...ector If necessary additional manual drying can be performed through lint free towel Insufflate cavities of instruments by using sterile compressed air If your washer disinfector does not have an auto...

Page 12: ...the device is obviously damaged smashed detached corroded or bent it must be discarded and not allowed to continue to be used If the accessories are found to be damaged please replace it beforeuse And...

Page 13: ...mum sterilization temperature 137 C Flash sterilization is not allowed on lumen instruments Storage Sterilized devices should be stored in a dry clean and dust free environment refer to label and inst...

Page 14: ...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 Contr...

Page 15: ...ed 17 GMDN Code Code 38347 Definition A hand held mains electricity AC powered dental device that includes a chuck or collet for attaching a dental endpiece e g drill bit bur reamer saw blade polishin...

Page 16: ...or central system The way of administration of energy or exchanging energy may indirectly injure the tissues in the mouth when misused by operators or device under condition of malfunction The device...

Page 17: ...R 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...

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