Woodpecker CA161 Caractéristiques techniques

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

产品描述

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.

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。

Figure 1 Structure of CA161

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

输出速度范围

100~1200 rpm

100~2500 rpm

Output Torque Range

输出扭矩范围

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

连续正向、连续反向和往复旋转

Continuous forward,

continuous reverse and

reciprocating rotation

(Axial reciprocating motion

is performed

simultaneously with all

rotational motions)

连续正向、连续反向和往复旋

转（轴向往复运动与所有旋转

运动同时进行）

File shank

attachment

Ф2.35mm ISO1797-1 Type1

Minimum fitting

length of shank

11mm

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

Table 1-2 Description of main part of Contra-angle handpiece

Num

ber

Model

Fig

Configuration 配置

CA161

1.Gear ratio 6:1

2.Output Speed Range：100~1200 rpm

3.Output Torque Range：0.4~5.0 N cm

4. Chuck type：Push-button

5.File shank attachment：Ф2.35mm

ISO1797-1 Type1

CA161-

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：Ф2.35mm

ISO1797-1 Type1

Table 1-3 Description of accessories of Contra-angle handpiece

mbe

Attachments

Fig

Configurat

ion

Description

Function

Remark

Lubricating

fitting

注油嘴

——

For

maintenance

of the

contra-angle

handpiece

during daily

use

Conneniently

bend the inside

of the

contra-angle

handpiece to

inject lubricant.

Real

accessory

Maximum overall

length of the rotary

instrument

46mm

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. 牙科弯手机用于夹持

车针、牙钻、牙锉等旋转器械，并带动其运动，实现切割、磨削、钻孔等牙科操

作。

2.2 Intended user：Professional dentists 目标用户：专业牙医

2.3 Intended patient：Patients who need root canal treatment 目标患者：需要进行根

管治疗的患者

3 Operation Principle

The Contra-angle handpiece is a kind of geared angle handpiece and is use to hold

and drive rotary instruments for the purposes of rotary processing, intended for the

endodontic treatment.

弯手机是一种带齿轮的角度手机，用于保持和驱动旋转器械，以进行旋转加工，

用于牙髓治疗。

4 Software

There is no software in the contra-angle handpieces.

5 Contraindication

1) The hemophilia patient is forbidden to use this equipment.

2) The patients or doctors with heart pacemaker are forbidden to use this equipment.

3) Patients with allergic constitution and a history of drug allergy are forbidden to

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.

5) Patients with heart disease and children should be cautious to use the equipment.

6) People with mental disorders should be cautious to use this equipment;

7) Patients with severe systemic infection or systemic diseases such as diseases in

heart, liver, kidney, hematopoietic 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 cautious to use this equipment.

6 Precaution

The Dangers:

1) Please check the operation outside oral cavity before treatment. Pay full

attention to check whether there is vibration, noise, or heating. If there is any

unexpected problem, please stop operation；治疗前请检查口腔外的操作。

充分注意检查是否有振动、噪音或发热。如有意外问题，请停止操作；

2) Avoid strong impact and dropping;避免强烈撞击和跌落；

3) Do not arbitrarily disassemble or modify the Contraangle Handpieces;请勿随

意拆卸或改装弯手机；

4) Please prepare a backup Contra-angle Handpieces to cope with the case that

Contra-angle Handpieces malfunction during operation;请准备备用弯手机，

以应对弯手机在使用过程中出现故障的情况；

5) Do not use nonrecommended shanks/files. Otherwise, the running

shanks/files may bend or fly out;不要使用非推荐的刀柄/锉刀。否则，运行

中的刀柄/锉刀可能会弯曲或飞出；

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

面的污渍会影响柄/锉的正确固定，导致柄/锉在使用过程中飞出；

7) Do not use the Contra-angle Handpieces without shanks/files；不要使用没有

柄/锉刀的弯手机；

8) Do not press the button while operating. Otherwise, it may cause head

overheating or flying shanks/files;操作时请勿按下按钮。否则，可能会导

致头部过热或飞刀柄/锉刀；

9) For safety, please wear protective goggles or dust mask while cutting;为安全

起见，切割时请佩戴防护眼镜或防尘口罩；

10) Do not exert too much force to treatment site;治疗部位不要用力过大；

11) Please carry out regular maintenance and inspection;请进行定期维护和检

查；

12) If the Contra-angle Handpieces has not been used for a period of time, before

operation, please maintain it as per maintenance regulations Maintenance.如

果弯手机有一段时间没有使用，在使用前，请按照保养规定维护保养。

13) Damage or serious wear will lead to increased transmission resistance,

abnormal sound and so on. As a result, the vibration of Contra-angle

Handpieces handpiece will be strong; the drill will shake greatly; and there

will be abnormal sound,etc. The operator should timely replace the

Contra-angle Handpieces according to clinical conditions. If the Contra-angle

Handpieces wears to a certain extent, please replace that with a new one；损

坏或严重磨损会导致传动阻力增加、异响等。因此，反角手机的振动会

很大；钻头会剧烈晃动；并且会有异响等。操作者应根据临床情况及时

更换弯手机。如果反角手机磨损到一定程度，请更换新的；

14) Improper use will damage this product, and then hurt the patients, users and

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

7.2 Use environment

Ambient temperature: +5℃ ~ +40℃

Relative humidity: 30% ~ 75%

Table 1-1 Differences between different models

Model

CA161

CA161-RR

Output Speed Range

输出速度范围

100~1200 rpm

100~2500 rpm

Output Torque Range

输出扭矩范围

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

连续正向、连续反向和往复旋转

Continuous forward, continuous reverse and

reciprocating rotation (Axial reciprocating

motion is performed simultaneously with all

rotational motions)

连续正向、连续反向和往复旋转（轴向往复运

动与所有旋转运动同时进行）

File shank attachment

Ф2.35mm ISO1797-1 Type1

Minimum fitting length of

shank

11mm

Maximum overall length

of the rotary instrument

46mm

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).

Not waterproof.

Classified by operation mode: Intermittent operating device

Degree of safety application in the presence of a flammable anesthetic mixture with

air, oxygen, or nitrous oxide: Equipment cannot be used in the presence of a

flammable anesthetic mixture with air, oxygen, or nitrous oxide.

8. Performance

Item 项目

Technical requirement 技术要求

Appearance and Structure 外观与

结构

1. The outer surface should be flat, smooth and tidy, without

obvious concave convex, crack and sharp edge. The contour of

transition should be clear without obvious scratch

2. The surface characters and marks shall be clear, accurate and

firm.

1、外表面应平整、光滑、整齐，无明显凹凸、裂纹和锐边。过渡

轮廓应清晰无明显划痕

2、表面文字和标记应清晰、准确、牢固。

Speed

Contra-angle handpiece output speed depends on the motor

output speed, according to the speed ratio is not the same,

different types of handpiece output speed is not the same.弯手机

输出转速取决于电机输出转速，根据速比不同，不同型号的手机输

出转速也不一样。

Rotation direction 旋转方向

The handpieces output spin is the same as the motor input spin.

手机输出旋转与电机输入旋转相同。

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

超过 80 dB。

9. Cleaning/ disinfection and sterilization

Steps

Contra-angle handpiece

Warnings

1.The contra-angle handpieces are not suitable for ultrasonic cleaning.

2.The contra-angle handpiece should not be immersed in strong detergents or

disinfectants (alkaline pH>9 or acid pH <5).

1.弯手机不适合超声波清洗。

2.弯手机不应浸泡在强清洁剂或消毒剂（碱性 pH>9 或酸性 pH<5）中。

Resistance to

sterilizing

procedure 对灭菌

程序的抵抗力

The contra-angle handpiece could be capable of being subjected to 250 cycles

of sterilizing procedure.手机可以进行 250 次消毒程序循环。

Preparation at

the Point of Use

使用点的准备

The post-operative process must be carried out immediately, no later than 30

minutes after the completion of the operation. The steps are as follows:

Remove the shanks/files and disconnect the contra-angle handpiece from

Motor handpiece. Remove gross soiling of the instrument with cold water

(<40°C) immediately after use. Don't use hot water (>40°C) as this can cause

the fixation of residuals which may influence the result of the reprocessing

process.术后过程必须立即进行，不迟于手术完成后 30 分钟。步骤如下：

拆下刀柄/锉刀并断开弯手机与马达手机的连接。使用后立即用冷水

(<40°C) 去除仪器上的脏污。不要使用热水 (>40°C)，因为这会导致残留物

固定，从而影响再处理过程的结果。

Transportati

on 运

输

The contra-angle handpiece should be safety stored and transported to the

point of reprocessing to avoid any damage and environment pollution.反角手机

应安全储存，运输至再处理点，以免造成损坏和环境污染。

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

reprocessing

The products must be reprocessed in a disassembled state.产品必须在拆卸状

态下进行再加工。

Pre-cleaning 预清

洁

Tools: tray, soft brush, clean and dry soft cloth

Perform manual pre-cleaning until the handpiece is visually clean. Rinse the

chuck of bur with running water for at least 10 seconds. Clean the surface with

a soft bristle brush.

Note: The water temperature should not exceed 40℃during the washing

stage, otherwise the protein will solidify and be difficult to remove.

工具：托盘、软刷、清洁干燥的软布

执行手动预清洁，直到机头目测清洁。用流水冲洗车针夹头至少 10 秒钟。

用软毛刷清洁表面。

注意：洗涤阶段水温不宜超过 40℃，否则蛋白质会凝固，难以去除。

Cleaning

Regarding cleaning/disinfection, rinsing and drying, it is to distinguish

between manual and automated reprocessing methods. Preference is

to be given to automated reprocessing methods, especially due to the

better standardizing potential and industrial safety.关于清洗/消毒、漂洗和干

燥，是区分手动和自动再处理方法。优先考虑自动再处理方法，特别是

由于

更好地标准化潜在和工业安全。

Automatic cleaning 自动清洗

The washer-disinfector should meet the requirements of the ISO 15883. Place

the contra-angle handpiece in the washer-disinfector carefully.

Ensure that contra-angle handpieces can not move freely in the

washer-disinfector.

The contra-angle handpiece are not permitted to contact with each other. Start

the program:

•

4min pre-washing with cold water(<40℃);

•

Emptying

•

5 min washing with a mild alkaline cleaner at 55℃；

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