Guilin woodpecker medical instrument Endo pace User manual

Contents

Preface ----------------------------------------------------------- 1

1 Product introduction ---------------------------------------- 1

2 Installation----------------------------------------------------- 3

3 Function and operation of product -------------------- 5

4 Operation instruction -------------------------------------- 7

5. Motor operation --------------------------------------------12

6 Cleaning, Disinfection and Sterilization---------------14

7 Storage and transportation -----------------------------20

8 Environmental protection --------------------------------20

9 After service -------------------------------------------------20

10 European authorized representative-----------------20

11 Symbol instruction ---------------------------------------20

12 Statement --------------------------------------------------21

13 EMC-Declaration of conformity -----------------------21

Note: the description on reciprocating mode is only applicable for the

device that has reciprocating mode.

Preface

Guilin Woodpecker Medical Instrument Co., Ltd is a professional

manufacturer researching, developing, and producing dental products.

Woodpecker owns a sound quality control system. Guilin Woodpecker

Medical Instrument Co., Ltd has two brands, Woodpecker and DTE.

Its main products include Ultrasonic Scaler, Curing light, Apex locator,

Ultrasurgery, Endo Motor, etc.

1 Product introduction

1.1 Product description

Endo Pace is mainly used in Endodontic treatment. It is a cordless endo

motor which can be connected to the matched Apex locator to add an

apex locator function. It can be used as a endo motor for preparation and

enlargement of root canals. By connecting the endo motor to the matched

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during the procedure and many automatic functions such as Apical Slow

Down can be activated.

Features:

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life.

b) Cordless portable endo motor which can be connected to the matched

Apex locator.

c) The contra angle can be rotated for 360°.

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Endo Pace

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1.3 Performance and composition

The device is composed of base, motor handpiece, contra angle, USB wire,

power adapter, protective silicon cover, etc.

1.4 Indications for Use

Endo Motor, Endo Pace is cordless endodontic treatment motorized

handpiece with root canal measurement capability. It can be used for

preparation and enlargement of root canals, or measuring the canal length.

And it can be used to enlarge the canals while monitoring the position of the

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1.5 Scope of application

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dentists.

1.6 Caution

Federal law restricts this device to sale by or on the order of a dentists.

1.7 Contraindication

a) The doctor with a pacemaker is disabled.

b) patients with cardiac pacemakers (or other electrical equipment) are

warned not to use small appliances (such as Electric razors, hair dryers,

etc.) patients are disabled.

c) Hemophilia patients are banned.

d) Use with caution in patients with heart disease, pregnant women and

young children.

1.8 Warnings

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1.8.3 Do not directly or indirectly place this device near heat source.

Operate and store this device in reliable environment.

1.8.4 This device requires special precautions regarding electromagnetic

compatibility (EMC) and must be in strict accordance with the EMC

information for installation and use. Do not use this equipment especially in

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devices, handheld and mobile high- frequency communication devices.

1.8.5 Long time use of Reciprocating Mode may result in motor handpiece

overheat, thus it should be left to cool for use. If the motor handpiece is

overheated frequently, please contact local distributor.

1.8.6 Please use the original contra angle. Otherwise it will not be used or

cause adverse consequences.

1.8.7 Please do not make any changes to the device. Any changes may

violate safety regulations, causing harm to the patient. There will be no

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1.8.8 Please use original power adapter. Other power adapter will result in

damage to lithium battery and control circuit.

1.8.9 The motor handpiece cannot be autoclaved. Use disinfectant of

neutral pH value or ethyl alcohol to wipe its surface.

1.8.10 Before the contra angle stopping rotating, do not press the push

cover of contra angle. Otherwise the contra angle will be broken.

1.8.11 Before the motor handpiece stopping rotating, do not remove

the contra angle. Otherwise the contra angle and the gear inside motor

handpiece will be broken.

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starting the motor handpiece.

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1.8.14 Error in replacing lithium batteries can lead to unacceptable risks, so

please contact local distributors to replace the battery if necessary.

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network power.

1.8.16 Don't maintain the machine while in use.

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1.9.1 Type of operation mode: Continuous operating device

1.9.2 Type of protection against electric shock: Class II equipment with

internal power supply

1.9.3 Degree of protection against electric shock: B type applied part

1.9.4 Degree of protection against harmful ingress of water: Ordinary

equipment (IPX0)

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mixture with air, oxygen, or nitrous oxide: Equipment cannot be used in

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oxide.

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1.9.7 The contact duration of applied part: 1 to 10 minutes.

1.9.8 The temperature of the surface of applied part may reach 41°C.

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1.10.1 Battery

Lithium battery in motor handpiece: 3.6V /850mAh

1.10.2 Power adapter

Input: ~100V-240V 50Hz/60Hz 0.4A Max

Output: DC5V/1A

1.10.3 Torque rang: 0.4N·cm-4.2N·cm

1.10.4 Speed rang: 100r/min~1500r/min

1.11 Working environment parameters

1.11.1 Environment temperature: +5°C ~ +40°C

1.11.2 Relative humidity: 30% ~ 75%

1.11.3 Atmospheric pressure: 70kPa ~ 106kPa

2 Installation

2.1 Basic accessories of product

USB Wire Disposable insulation sleeves Protective silicon cover

2.2 Instructions for contra angle

2.2.1 The contra angle adopts precision gear transmission, and the

transmission ratio is 6:1.

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contra angle with disinfectant of neutral PH value. After disinfection, lubricate

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high pressure (134°C, 2.0bar~2.3bar (0.20MPa~0.23MPa)).

2.2.3 The contra angle can only be used cooperatively with this device.

Otherwise the contra angle will be damaged.

2.3 Installation and removal of contra angle.

2.3.1 Installation

Align any locating pin of the contra angle with the positioning slot on the

motor handpiece and push the contra angle horizontally. The four locating

pins on the contra angle are inserted into those four positioning holes on the

motor handpiece. A “click” sound indicates that the installation is in place.

The contra angle can be rotated 360° freely.

The contra angle rotates 360° so that the OLED display can always be

viewed easily.

2.3.2 Removal

Pull out the contra angle horizontally when the motor handpiece does not

run.

Warnings:

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handpiece.

b) After installation, please check and confirm that the contra angle has

been well installed.

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Warnings:

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Be careful when inserting files to avoid injury to fingers.Inserting and

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contra angle.

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– 2.350 mm)

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Warnings:

Before plugging and pulling out the file, the motor handpiece must be

stopped.

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contra angle.

3 Function and operation of product

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CW Clockwise rotation, forward ration

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CCW

Counter clockwise rotation, reverse rotation

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hydroxide and other solutions

REC

Reciprocating motion

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some special angle.

ATR

Adaptive torque reverse

Up to setting torque, the motor will move with reciprocating ATR mode ;

when torque reduce to normal value, the motor will clockwise rotate.

Forward Angle

Activating in REC and ATR operation mode. ATR mode: adjustable every

10 degrees, adjustment range: 60°-400°.

REC mode: adjustable every 10 degrees,

adjustment range: 20°-400°.

Reverse Angle

Activating in REC operation mode

Adjustable every 10 degrees, adjustment range: 20°-400°.

Activating in ATR operation mode

Adjustable every 10 degrees, adjustment range: 20°-forward angle.

Operation Mode

4 operation modes for canal shaping and measurement.

Such as CW, CCW, REC and ATR.

Speed File rotation speed.

Torque

(Torque Limit /

Trigger Torque)

For CW and CCW modes, the torque value (Torque Limit) that triggers

reverse rotation. For ATR mode, the torque value (Trigger Torque)

that triggers ATR action.

The options of such as Apical Action and Apical Slow Down are only

available when the matched Apex locator is connected.

AP 00 Apical foramen.

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Apical Slow

Down

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Activating in CW and CCW operation mode.

3.3 Display Screens

3.3.1 Display Screens for 4 Operation Modes and Standby

3.3.1.1 CW Mode

The motor handpiece rotates forward 360°,clockwise direction. Used rotaty

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3.3.1.2 CCW Mode

The motor handpiece rotates counterclockwise direction only. This mode

is used to inject calcium hydroxide and other medicant. When this mode is

being used, a double-beep sounds continuously.

3.3.1.3 REC Mode

F: Forward angle, R: Reverse angle F/R: Forward angle/ Reverse angle

Forward Angle<Reverse Angle, such as F: 30/R: 150, effective cutting

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:22'3(&.(5:21(:22'3(&.(5:21(

Forward Angle>Reverse Angle, such as F: 180/R: 30, effective cutting

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SENDONELINE S1.

3.3.1.4 ATR Mode

ATR: Adaptive Torque Reverse function.

3.3.2 Torque Display

This appears when the motor is running. Meter shows the torque loadon the

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4 Operation instruction

4.1 Working environment parameters

4.1.1 Environment temperature: +5°C ~ +40°C

4.1.2 Relative humidity: 30% ~ 75%

4.1.3 Atmospheric pressure: 70kPa ~ 106kPa

4.2 Starting and stopping of motor handpiece

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then the motor handpiece will enter Standby interface. The interface

displays are as follow:

Standby interface

b)Under Standby interface, press Main button, and then the motor

handpiece will enter Working interface. The interface displays are as follow:

Working interface

Press the Main button again, and then the motor handpiece backs to

Standby interface.

c) Hold down the Setting button “P”, then press Main button to turn off

motor handpiece. In the standby interface without any key operation, 3 ~ 30

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4.3 Selecting customized program sequence number

The motor handpiece has 10 memory programs(M0-M9) and 5 preset

programs, press Adjusting button “+”/“-” to change customized program

sequence number during standby state.

M0-M9 is a memory program for canal shaping and measurement, every

memory program has its own parameters such as Operation mode, speed

and torque, all these parameters can be changed.

4.4 Parameter setting

Before starting of motor handpiece, please check the operation

mode is correct.

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the parameters are excepted before starting of motor handpiece,

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It has 4 operation modes for canal shaping: CW, CCW, REC and

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of these modes.)

Press Setting button “P” once during standby state, press

Adjusting button “+”/“-” to select correct Operation mode.

CCW mode is used to inject calcium hydroxide and other

medicant. When this mode is being used, a double-beep sounds

continuously,used for indicating counter clockwise rotation

happening.

Repeatedly press Setting button “P” to check all the next level parameters of this operation

mode are expected, press Adjusting button “+”/“-” to select if not.

The speed setting can be adjusted from 100 r/min to1500 r/min.

Press Adjusting button “+”/“-” to increase or decrease speed. Long

press to fast increase or fast decrease speed.

In ATR mode, speed of 100~500r/min are available.

In REC mode, speed of 100~500r/min are available.

The torque setting can be adjusted from 0.4N·cm to 4.2N·cm.

Press Adjusting button “+”/“-” to increase or decrease torque. Long

press to fast increase or fast decrease torque.

In ATR mode, the Trigger Torque of 0.4N·cm~4.0N·cm are

available.

In REC mode, the torque of 2.0N·cm~4.2N·cm

are available.

Forward Angle: activating in REC and ATR operation mode.

Reverse Angle: activating in REC and ATR operation mode.

F: Forward Angle R: Reverse Angle

Press Adjusting button “+”/“-” to change angle,adjustable every 10

degrees.

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reverse angle should be greater than or equal to 120 degrees,

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cutting angle is Reverse Angle, it is suitable for used the

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cutting angle is Forward Angle, it is suitable for used the

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Remarks: only 60°~400° forward angles are

available in ATR mode.

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point inside the canal determined by the Flash Bar setting.

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reaches the reference point, the motor will response according to

setting, it can be Reverse , Stop and OFF.

Press Adjusting button “+”/“-” to change.

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reach the reference

point.

Stop: automatically rotation stop when reach

the reference point, upward a little bit and will

rotate again.

Reverse: automatically reverses rotation when reach or pass

the reference point, upward a little bit, the rotation direction will

change back again.

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inserted into the canal.

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Main button is used to start and stop the motor handpiece.

ON: Motor starts automatically.

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taken out of the canal.

Press Adjusting button “+”/“-” to change.

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Main button is used to start and stop the motor handpiece.

ON: Motor stops automatically.

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tip approaches the reference point.

P ress Adjusting button “+”/“-” to change.

OFF: Disable Apical Slow Down function.

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the reference point.

4.5 Preset program selection

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Press Adjusting button “+”/“-” to switch to preset program(M0-M9,

preset program 1-5 ), the interface will show as left.

Long press Setting button “P” to entry preset program during

standby state, the interface will show as left.

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system.

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SUHVV0DLQEXWWRQWRFRQ¿UP

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from default setting.

If want to change back to default setting, long press Setting button

“P” to entry preset program during standby state, select "W3-

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preset program can also restore the default setting.

Changing the preset program default setting is not recommended,

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4.6 Handpiece functions setting

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press Main button to entry handpiece functions setting, press Setting button

“P” till target setting, press Adjusting button “+”/“-” to adjust, then press Main

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button “P” and press Main button to entry handpiece functions

setting, the software version number will appear on the display

screen.

After 3 seconds of displaying the Software Version on the screen,

the time of "Auto Power OFF" can be change, press Adjusting

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The default value is 5 min.

Press Setting button “P”again, the time of " Auto Standby Scr"

can be change, press Adjusting button “+”/“-” to adjust, then

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The default is 10 sec.

Press Setting button “P”again, the time of " Auto Standby Scr"

can be change, press Adjusting button “+”/“-” to adjust, then

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The default is 10 sec.

Press Setting button “P”again, the "Dominant Hand" can be

change, press Adjusting button “+”/“-” to adjust, then press to

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The right hand and the left hand can be set.

Press Setting button “P”again, the "Calibration" can be change,

press Adjusting button “+”/“-” to select “ON”, then press to "Main"

button to calibration.

Before calibrating, making sure the original contra angle is

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if calibration without original contra angle or any load on contra

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contra angle, the contra

angle shall be calibrated before use.

Press Setting button “P”again, the "Beeper Volume" can be

change,press Adjusting button “+”/“-” to adjust, then press to

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The"Beeper Volume"can be set from 0-3.

Vol.0: Mute.

Press Setting button “P” again, the "Restore Defaults" can be

change, press Adjusting button “+”/“-” to select “ON”, then press

to "Main"

button to restore defaults.

4.7 Protective function of automatic reverse

During operation, if the load value exceeds the preset torque value, the

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would return to normal rotation mode when the load is below the preset

torque value again.

Cautions:

1.Protective function of automatic reverse is ONLY suitable for CW mode.

2.In REC mode, when the load value is higher than preset torque value, if

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change to reverse rotation, and if Forward angle is less than Reverse angle,

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3.This function is forbidden under CCW mode, ATR mode.

4.When the motor handpiece battery indicator indicates a low battery

capacity, the low battery capacity is insufficient to support the motor

handpiece to reach the limit torque value, that is, the auto-reverse function

will not work properly. Please charge it in time.

5.If the motor handpiece is under load all the time, the machine may stop

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motor handpiece for a while until the temperature drops.

4.8 Motor operation

Please set operation mode, torque and speed as per the recommended

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When using as motor alone mode, the torque bar will show on the screen.

4.9 Battery Charging

There is a built-in rechargeable lithium battery in the motor handpiece.Insert

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correctly connected.

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After charging, please unplug the power adapter.

This device must use the original power adapter.

4.10 Replacing Battery

If the battery needs to be replaced,please contact local distributors.

Here is how to replace the battery.

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b)Use tweezers etc. to open the rubber cover and then remove the screw.

c)Gently separate the upper and lower cover of the Motor handpiece.

d)Remove the old battery and disconnect the connector.

e)Connect the new battery and put it in the motor handpiece.

f)Fasten the upper and lower cover of the Motor handpiece, tighten the

screws and install the rubber cover.

4.11 Oiling of contra angle

Only the original oil injection nozzle can be used for oiling of contra angle.

The contra angle needs to be lubricated after cleaning and disinfection, but

before sterilization.

1.Firstly, screw the injecting nozzle into jet of oil bottle. (Around 1 to 3

circles)

2.Next, plug the nozzle into the end part of contra angle, and then grease

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3.Vertically place the end part of contra angle more than 30 minutes to let

go the redundant oil under gravity.

Warnings

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Cautions

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safely hold the contra angle while greasing.

b: Do not use a swirling nozzle. Swing nozzle can only be used for injection

of gas, not for oiling.

5. Motor operation

5.1 Please set operation mode, torque and speed as per the

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Motor alone mode

When using as motor alone mode,

the torque bar will show on the

screen.

(more information about torque

bar, please see chapter 4.4, 4.5 Screen

display )

Motor combined canal

measurement function mode

Connect to the matched Apex

locator to add a canal measurement

function.

Connecting the USB wire and

measuring wire.

After connecting the USB wire,

if it is well connected, the device

will display “CONNECTED!” and

make a prompt tone.

While disconnecting the USB wire

with the device, the device will

display “DISCONNECT!” and

make a prompt tone.

Installing:

Put the protective silicon cover

onto the contra angle.

Removing:When removing the

protective silicon cover, pull it

straight out slowly.

Connection testing

Strongly recommend check the connection testing every

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contra angle and check that all the bars on the meter on

the screen light up, and the motor should be reversed

continuously, otherwise, the USB wire, measuring wire or

contra angle should be replace.

Canal measurement state interface

a. Canal length indicator bar

b. Indication number Digital numbers 00-16 do not

represent the actual length from the apical foramen. It

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foramen.

c. Apical foramen.

1) Make sure that Endo Pace

is well connected with the Apex locator.

2) Hook the lip hook in the corner of the patient’s mouth.

3) Power on the motor handpiece to operate.

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monitored during the procedure.

Setting parameters of automatic functions as needed, such

as Apical Action, Auto Start, etc(more information about

automatic functions, please see chapter 4.6 Parameter

setting).

5.2 Trouble shooting

Failure Possible cause Solutions

There is continuous beep

sounds after starting the

motor handpiece.

The continuous beep sound

is indicating that the motor

handpiece is under CCW

mode.

Stop the motor handpiece and

change the operating mode to

CW Mode.

Contra angle calibration

failure

Calibration failure caused by

strong resistance of contra

angle

Clean the contra angle, and

recalibrate after oil injection.

Motor handpiece heating Under Reciprocating Motion

Mode, the using time is too

long.

Stop use. Use after the

temperature of motor

handpiece drops.

The time of endurance

becomes shorter after

charging.

Battery capacity becomes

smaller.

Please contact local distributor

or manufacturer.

No sound Beeper Volume set to 0.

Vol.0: Mute.

Set Beeper Volume to 1,2,3.

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is stuck at the root canal.

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7RRKLJKORDGWRUTXHRI¿OH

Choose CCW Mode, start the

motor handpiece, and take

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While connected to

compatible Apex locator, the

device has no response.

1. Poor contact of the USB

wire.

2. Damage of the USB wire.

1. Unplug and plug the USB

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connection.

2.Contact supplier to replace

the USB wire.

6 Cleaning, Disinfection and Sterilization

6.1 Foreword

For hygiene and sanitary safety purposes, the contra-angle, the protective

silicon cover must be cleaned, disinfected and sterilized before each usage

to prevent any contamination. This concerns the first use, as well as all

subsequent uses.

6.2 General recommendations

6.2.1 Use only a disinfecting solution which is approved for its efficacy

(VAH/DGHM-listing, CE marking, FDA and Health Canada approval) and in

accordance with the DFU of the disinfecting solution manufacturer.

6.2.2 Do not place the contra-angle in a disinfectant solution or in an

ultrasonic bath.

Do not use chloride detergent materials.

6.2.3 Do not use bleach or chloride disinfectant materials.

6.2.4 For your own safety, please wear personal protective

equipment(gloves, glasses, mask).

6.2.5 The user is responsible for the sterility of the product for the first

cycle and each further usage as well as for the usage of damaged or dirty

instruments where applicable after sterility.

6.2.6 The water quality has to be convenient to the local regulations

especially for the last rinsing step or with a washer-disinfector.

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for use.

6.2.8 The contra-angle needs to be lubricated after cleaning and

disinfection, but before sterilization.

6.3 Cleaning and disinfection steps for the motor handpiece, the

AC adapter and the base.

Before and After each use, all the objects that were in contact with infectious

agents should be cleaned using towels impregnated with a disinfecting and

detergent solution (a bactericidal, fungicidal and aldehyde free solution)

approved by VAH/DGHM-listing, CE marking, FDA and Health Canada.

Warning: Do not sterilize the motor handpiece, the AC adapterand the

base.

6.3.1 Pre-Op processing Before each use, the handpiece, charger, and

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Warning: The handpiece, charger, and base cannot be cleaned and

disinfected with automatic equipment. Manual cleaning and disinfection is

required.

6.3.1.1 Manual cleaning steps:

1. Take out the handpiece, charger, and base on the workbench.

2. Wet the soft cloth completely with distilled water or deionized water,

and then wipe all the surfaces of the components such as the handpiece,

charger, base, etc. until the surface of the component is not stained.

3. Wipe the surface of the component with a dry soft nap-free cloth.

4. Repeat the above steps at least 3 times.

Note:

a)Use distilled water or deionized water for cleaning at room temperature.

6.3.1.2 Manual disinfection steps:

1. Soak the dry soft cloth with 75% alcohol.

2. Wipe all surfaces of headpiece, charger, base and other components with

a wet soft cloth for at least 3 minutes.

3. Wipe the surface of the component with a dry soft nap-free cloth.

Note:

a) The cleaning and disinfection must be performed within 10min before

use.

b) The disinfectant used must be used immediately, no foaming is allowed.

c) In addition to 75% alcohol, you can use non-residue disinfectants such

Oxytech from Germany, but you must respect the concentration,

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d) After cleaning and disinfecting the handpiece, you must install a

disposable isolation sleeve before use.

6.3.1.3 Post-Op processing

After each use, clean and disinfect the handpiece, charger, and base within

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Tools: Nap-free soft cloth, tray

1. Remove the contra-angle from the handpiece, place it in a clean tray, and

then remove the disposable isolation sleeve from the handpiece.

2. Soak the nap-free soft cloth with distilled water or deionized water,

and then wipe all the surfaces of the components such as the handpiece,

charger, base, etc. until the surface of the component is not stained.

3. Wet the dry soft cloth with 75% alcohol, and then wipe all surfaces of the

handpiece, charger, base and other components for 3 minutes.

4. Put the handpiece, charger, base and other components back into the

clean storage area.

Note:

a) The cleaning and disinfection must be performed within 10min before

use.

b) The disinfectant used must be used immediately, no foaming is allowed.

c) In addition to 75% alcohol, you can use non-residue disinfectants

such as Oxytech from Germany, but you must respect the concentration,

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d) After cleaning and disinfecting the handpiece, you must install a

disposable isolation sleeve before use.

6.4 The cleaning, disinfection and sterilization of contra-angle,

protective silicon cover, as follow.

Unless otherwise stated, they will be hereinafter referred to as“products”.

Warnings:

The use of strong detergent and disinfectant (alkaline pH>9 or acid pH <5)

will reduce the life span of products. And in such cases, the manufacturer

takes no responsibility.

The products may not be exposed to temperature above 138°C.

Processing limit

The products have been designed for a large number of sterilization cycles.

The materials used in manufacture were selected accordingly. However

with every renewed preparation for use, thermal and chemical stresses will

result in ageing of the products. The maximum number of sterilizations for

products is 250 times.

6.4.1 Initial processing

6.4.1.1 Processing principles

It is only possible to carry out effective sterilization after the completion

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responsibility for the sterility of products during use, only sufficiently

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disinfection and sterilization, and that the validated parameters are adhered

to during every cycle.

Please also observe the applicable legal requirements in your country as

well as the hygiene regulations of the hospital or clinic, especially with

regard to the additional requirements for the inactivation of prions.

6.4.1.2 Post-operative treatment

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

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

1. Remove the products from the base, and rinse away the dirt on the

surface of handpiece with pure water (or distilled water/deionized water);

2. Dry the products with a clean, soft cloth and place it in a clean tray.

Notes:

a) The water used here must be pure water, distilled water or deionized

water.

6.4.2 Preparation before cleaning

Steps:

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

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2. Remove the Contra-angle and connecting wire from the handpiece in

sequence, and then put them into a clean tray;

3. Use a clean soft brush to carefully protective silicon cover,head and back

cover of the contra-angle until the dirt on surface is not visible. Then use

soft cloth to dry the products and put them into a clean tray. The cleaning

agent can be pure water, distilled water or deionized water.

Disassembling steps

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b) When removing the protective silicon cover, pull it straight out slowly.

c) When inserting and removing the contra-angle, turn thehandpiece power

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6.4.3 Cleaning

The cleaning should be performed no later than 24 hours after the

operation.

The cleaning can be divided into automated cleaning and manual cleaning.

Automated cleaning is preferred if conditions permit.

6.4.3.1Automated cleaning

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EN ISO 15883.

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product.

• The cleaning procedure is suitable for the product, and the irrigating period

LVVXႈFLHQW

It is recommended to use a washer-disinfector in accordance with EN

ISO 15883. For the specific procedure, please refer to the automated

disinfection section in the next section "Disinfection".

Notes:

a) The cleaning agent does not have to be pure water.It can be distilled

water, deionized water or multi-enzyme. But please ensure that the selected

cleaning agent is compatible with the product.

b) In washing stage, the water temperature should not exceed 45 °C,

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c) After cleaning, the chemical residue should be less than 10mg / L.

6.4.4 Disinfection

Disinfection must be performed no later than 2 hours after the cleaning

phase. Automated disinfection is preferred if conditions permit.

6.4.4.1Automated disinfection-Washer-disinfector

·The washer-disinfector is proved to be valid by CE certification in

accordance with EN ISO 15883.

·Use high temperature disinfection function. The temperature does not

exceed 134 ° C, and the disinfection under the temperature cannot exceed

20 minutes.

·The disinfection cycle is in accordance with the disinfection cycle in EN

ISO 15883.

Cleaning and disinfecting steps by using Washer-disinfector

1. Carefully place the product into the disinfection basket. Fixation of

product is neededonly when the product is removable in the device. The

products are not allowed to contact each other.

2. Use a suitable rinsing adaptor, and connect the internal water lines to the

rinsing connection of the washer-disinfector.

3. Start the program.

4. After the program is finished, remove theproductfrom the washer-

disinfector, inspect (refer to section "Inspection and Maintenance") and

packaging (refer to chapter "Packaging"). Dry the productrepeatedly if

necessary (refer to section "Drying").

Notes:

a) Before use, you must carefully read the operating instructions provided

by the equipment manufacturer to familiarize yourself with the disinfection

process and precautions.

b) With this equipment, cleaning, disinfection and drying will be carried out

together.

c) Cleaning: (c1) The cleaning procedure should be suitable for the product

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wash for 3 minutes, wash for another 5 minutes, and rinse it for twice

with each rinse lasting for 1 minute. (c2) In the washing stage, the water

temperature should not exceed 45 °C, otherwise the protein will solidify

and it is difficult to remove. (c3) The solution used can be pure water,

distilled water, deionized water or multi-enzyme solution, etc., and only

freshly prepared solutions can be used. (c4)During the use of cleaner, the

concentration and time provided by manufacturer shall be obeyed. The

used cleaner is neodisher MediZym (Dr. Weigert).

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(d2) For the disinfection here,the temperature is 93 ° C, the time is 2.5 min,

and A0>3000

e) Only distilled or deionized water with a small amount of microorganisms

(<10 cfu/ml) can be used for all rinsing steps. (For example, pure water that

is in accordance with the European Pharmacopoeia or the United States

Pharmacopoeia).

f) After cleaning, the chemical residue should be less than 10mg / L.

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h) Regularly repair and inspect the disinfector.

6.4.5 Drying

If your cleaning and disinfection process does not have an automatic drying

function, dry it after cleaning and disinfection.

Methods:

1. Spread a clean white paper (white cloth) on the flat table, point the

product against the white paper (white cloth), and then dry the product with

filtered dry compressed air (maximum pressure 3 bar). Until no liquid is

sprayed onto the white paper (white cloth), the productdrying is completed.

2. It can also be dried directly in a medical drying cabinet (or oven). The

recommended drying temperature is 80°C~120°C and the time should be

15~40 minutes.

Notes:

a) The drying of product must be performed in a clean place.

b) The drying temperature should not exceed 138 °C;

c) The equipment used should be inspected and maintained regularly.

6.4.6 Inspection and maintenance

6.4.6.1 Inspection

In this chapter, we only check the appearance of the product.

1. Check the product. If there is still visible stain on the product after

cleaning/disinfection, the entire cleaning/disinfection process must be

repeated.

2. Check the product. If it is obviously damaged, smashed, detached,

corroded or bent, it must be scrapped and not allowed to continue to be

used.

3. Check the product. If the accessories are found to be damaged, please

replace it before use. And the new accessories for replacement must be

cleaned, disinfected and dried.

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service life (number of times), please replace it in time.

6.4.6.2Maintenance

Sterilizable Oil lubrication shall be applied to dried contra angle.

The nozzle of cleaning lubricant is aligned with the air intake hole at the end

of thecontra angle to inject oil for 1-2 seconds.

6.4.7 Packaging

Install the disinfected and dried product and quickly package it in a medical

sterilization bag (FDA cleared wrap or pouch).

Notes:

a) The package used conforms to ISO 11607;

b) It can withstand high temperature of 138 °C and has sufficient steam

permeability;

c) The packaging environment and related tools must be cleaned regularly

to ensure cleanliness and prevent the introduction of contaminants;

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6.4.8 Sterilization

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