FKG Rooter X3000 User manual

User Manual

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Table of Contents
1. Product introduction.................................................................................................... 4
1.1 Description of the device............................................................................................................................. 4
1.2 Components and accessories ...................................................................................................................... 5
1.3 Technical specifications............................................................................................................................... 6
1.4 Warnings ..................................................................................................................................................... 6
1.5 Important precautions ................................................................................................................................ 7
1.6 Device safety classification.......................................................................................................................... 7
1.7 Environmental parameters.......................................................................................................................... 7
1.8 User qualification ........................................................................................................................................ 7
1.9 Intended use................................................................................................................................................ 7
2. Device setup instructions ............................................................................................. 7
2.1 Contra-angle setup...................................................................................................................................... 7
2.2 File setup ..................................................................................................................................................... 8
2.3 Apex locator setup ...................................................................................................................................... 9
3. Device Operation modes and display interface .......................................................... 11
3.1 Motor modes............................................................................................................................................. 11
3.2 Apex locator Operation mode................................................................................................................... 12
3.3 Combined Motor and Apex locator Operation mode ............................................................................... 12
3.4 Display interface........................................................................................................................................ 13
4. Device operating instructions..................................................................................... 14
4.1 Setting interface and button description .................................................................................................. 14
4.2 Power ON and power OFF the device ....................................................................................................... 14
4.3 Select User Programs ................................................................................................................................ 14
4.4 Set User Program parameters ................................................................................................................... 15
4.5 Select FKG File Systems ............................................................................................................................. 17
4.6 Set device parameters............................................................................................................................... 18
4.7 Torque overload protection ...................................................................................................................... 19
4.8 Apex locator limitations ............................................................................................................................ 19
5. Troubleshooting......................................................................................................... 21
6. Cleaning, Disinfection and Sterilization ...................................................................... 21
6.1 Foreword ................................................................................................................................................... 21
6.2 General recommendations........................................................................................................................ 21
6.3 Step-by-Step Procedure ............................................................................................................................ 22

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7. Maintenance.............................................................................................................. 23
7.1 Calibration ................................................................................................................................................. 23
7.2 Lubrification of the contra-angle............................................................................................................... 23
7.3 Charging of the battery ............................................................................................................................. 23
7.4 Replacement of the battery ...................................................................................................................... 23
8. Storage ...................................................................................................................... 24
9. Transportation ........................................................................................................... 24
10. Environmental protection .......................................................................................... 24
11. After sales service ...................................................................................................... 24
12. Symbol instruction ..................................................................................................... 24
13. Statement .................................................................................................................. 25
14. EMC-Declaration of conformity.................................................................................. 26
14.1 Technical Description Concerning Electromagnetic Emission................................................................... 26
14.2 Technical Description Concerning Electromagnetic Immunity.................................................................. 26

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1. Product introduction
1.1 Description of the device
The Rooter®X3000 device is a cordless endo motor with an integrated root canal apex locator. It
can be used as an endo motor for preparation of tooth root canals, or as an apex locator device
to help to determine the root canal working length. It can also be used to prepare the canals
while monitoring the relative position of the endodontic instrument tip inside the canal
(combined Motor and Apex locator mode).

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1.2 Components and accessories
# Designation Reference FKG
1 Motor handpiece 08.971.00.001.FK
2 Charging base 08.971.00.002.FK
3 Contra-angle [4.7/1]
08.971.00.003.FK
4 Spray noozle 08.971.00.004.FK
5 Measuring wire
08.971.00.005.FK
6 File clip 08.971.00.006.FK
7 Lip hook 08.971.00.007.FK
8 Touch probe 08.971.00.008.FK
9 Protective silicone cover
08.971.00.009.FK
10 "O"-ring 08.971.00.010.FK
11 Universal AC-Adapter
08.971.00.011.FK
- User manual -
- Apex locator troubleshooting card -
- Package content list -

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1.3 Technical specifications
a) Motor handpiece lithium battery specification
3.7V / 2000mAh
b) Power adapter specification
Input: ~100V-240V 50Hz/60Hz 0.5-0.2A
Output: DC5V/1A
c) Motor handpiece mechanical specification
Torque range: 0.4Ncm-4.0Ncm
Speed range: 100rpm-3’300rpm
d) Wireless charging specification
Frequency range: 112-205KHz
Maximum RF output power of the product: 9.46dBuA/m@3m
1.4 Warnings
Please carefully read this Instruction Manual before first operation.
a) Do not use this device for anything else than its intended use (refer to Chapter 1.9).
a) Use original components and accessories only.
b) Always set torque and speed following the recommendations of the file manufacturer.
c) Make sure the contra-angle is well connected before to start the motor handpiece (refer
to Chapter 2.1).
d) Make sure the instrument is well connected and locked before to start the motor
handpiece (refer to Chapter 2.2).
e) Do not connect or disconnect the contra-angle while the motor is running.
f) Do not disconnect the instrument while the motor is running.
g) Be sure to be able to power OFF the device at any time.
h) Operate and store the device in reliable environment (refer to Chapter 1.7 and Chapter
8).
i) Do not use the device in the vicinity of fluorescent lamps, radio transmitting devices,
remote control devices, handheld, and mobile high-frequency communication devices.
j) The motor handpiece, power adapter and charging base are not autoclavable (refer to
Chapter 6).
k) Replace the lithium battery according to the instructions (refer to Chapter 7.4).
l) Do not make any changes or modifications to the device. Any change, modification or any
other alteration of the device may violate safety regulations, causing harm to the patient.
m) In case of motor handpiece frequent overheat, contact a local distributor.
n) Do not directly or indirectly place the device near heat sources.
o) Do not cover the device.
p) Remove the battery of the device in case of long period storage.

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1.5 Important precautions
These precautions are critical to insure safe operation and use.
a) Do not use this device on patients who have implanted pacemakers, defibrillators, or any
other implantable devices.
b) Do not use this device on patients suffering from Hemophilia.
c) Use with caution on patients with heart disease, pregnant women, and young children.
1.6 Device safety classification
a) Type of Operation mode: Continuous operating electromedical device
b) Type of protection against electric shock: Class II equipment with internal power supply
c) Degree of protection against electric shock: B type applied part
d) Degree of protection against harmful ingress of water: Ordinary equipment (IPX0)
e) 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.
f) Applied part: contra-angle , lip hook, file clip, touch probe.
The contact duration of applied part: 1 to 10 minutes.
Maximum temperature of applied part: 46.6°C.
1.7 Environmental parameters
a) Operating ambient temperature: +5°C ~ +40°C
b) Operating relative humidity: 30% ~ 75%
c) Operating atmospheric pressure: 70kPa ~ 106kPa
1.8 User qualification
a) The device must be operated in hospital or clinic by legally qualified dentists.
b) It is assumed that the operator is familiar with root canal apex locator.
1.9 Intended use
a) The Rooter®X3000 is an endo motor, an electro-medical device intended to drive
mechanical instruments intended for dental root canal treatment (endodontic files).
b) In addition, it is intended to help to determine the working length (apex locator
functionality).
2. Device setup instructions
2.1 Contra-angle setup
2.1.1 Before the first use and after each treatment
a) Clean and disinfect the contra-angle (refer to Chapter 6).
b) Lubricate the contra-angle (refer to Chapter 7.2).
c) Sterilize the contra-angle (refer to Chapter 6).
2.1.2 Warnings
a) Use original contra-angle only.
b) Make sure the contra-angle is well connected before to start the motor handpiece.
c) Do not connect or disconnect the contra-angle while the motor is running.
2.1.3 Connecting the contra-angle
1. Align the three pins of the contra-angle with the positioning slots of the motor handpiece.

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2. Push the contra-angle horizontally. A “click” sound indicates that the installation is in
place.
3. The contra-angle must rotate 360° freely.
2.1.4 Disconnecting the contra-angle
Pull out the contra-angle horizontally.
2.2 File setup
2.2.1 Warnings
a) Make sure the instruments are compliant to ISO1797 standard (Shanks for rotary and
oscillating instruments).
b) Connecting and disconnecting files without holding down the Push button may damage
the chuck of the contra-angle.
c) Be careful when manipulating files to avoid injury to fingers.
d) Make sure the file is well connected and locked before to start the motor handpiece.
e) Do not disconnect the file while the motor is running.
2.2.2 Connecting a file
Plug the file into the hole of contra-angle head.
1. Hold down the Push button on the contra-angle and push the file.
2. While pushing, rotate the file clockwise and counterclockwise until its shank is aligned
with the contra-angle latch groove.
3. When the shank is aligned and slips into place, release the Push button to lock the file
into the contra-angle.

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2.2.3 Disconnecting a file
Hold down the Push button and pull out the file.
2.3 Apex locator setup
2.3.1 Warnings
a) In Apex locator mode, the file clip must properly hold the file.
b) In case of bad or wrong connection signal, replace the measuring wire.
c) In apex locator mode it is suggested to install the motor handpiece in the charging base
to get better visual angle.

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d) The Apex locator detects the canal apical foramen, not the tooth anatomical apex. This
could explain some differences between the apex locator signal and an X-ray image.
e) Not all conditions are ideal for working length determination. To be informed about the
Apex locator limitations, refer to Chapter 4.8.
2.3.2 Connecting apex locator wires
1. Connect the measuring wire to the motor handpiece (USB socket at the back).
2. Connect the lip hook to the white socket of the measuring wire.
3. Connect the file clip plug to the black socket of the measuring wire (this is not required in
combined Motor and Apex locator mode).

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2.3.3 Connection testing
It is strongly recommended to check the connection quality before every use.
1. In Apex locator mode, clip the holder on lip hook and check that all the indicator bars light
up, as shown below:
2. In combined Motor and Apex locator mode, touch the lip hook with the file and check
that all the indicator bars light up, as shown below:
3. Device Operation modes and display interface
3.1 Motor modes
3.1.1 CW Operation Mode (Clockwise continuous rotation mode)
In this mode, the motor handpiece rotates in clockwise direction only (forward direction).
3.1.2 CCW Operation Mode (Counterclockwise continuous rotation mode)
In this mode, the motor handpiece rotates in counterclockwise direction only (reverse direction).
In this mode, a double beep sounds continuously.
3.1.3 REC Operation Mode (Reciprocating motion mode)
In this mode, the motor handpiece generates reciprocating motion only (F: Forward angle, R:
Reverse angle).

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3.1.4 ATR Operation Mode (Adaptive Torque Reverse mode)
In this mode, the motor handpiece rotates in clockwise direction and generates reciprocating
motion when the torque load on the file is higher than the set torque limit.
3.2 Apex locator Operation mode
3.2.1 EAL Operation Mode (Electronic Apex Locator)
This mode is intended for working length determination only.
In this mode, the motor handpiece does not run.
3.3 Combined Motor and Apex locator Operation mode
When a file is inside the canal and the lip hook is in contact with patient’s lip, the device enters
automatically in the combined Motor and Apex locator mode.

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3.4 Display interface
Stand-by interfaces
While the motor is not running, the display shows the actual settings of the
motor.
a. User Program (M0-M9)
or
Manufacturer preset program (refer to Chapter 4.5)
b. Battery level
c. Set speed (rpm)
d. Set torque limit (Ncm)
e. Motor Operation mode
f. Set forward angle (°deg)
g. Set reverse angle (°deg)
Motor Operation interface
While the motor is running, the display shows the torque load on the file.
a. Set speed (rpm)
b. Set torque limit (Ncm)
c. Real time torque (Ncm)
d. Torque display scale (Ncm)
Combined Motor and Apex locator Operation interface
a. File progression indication bar
b. File progression indication number
The numbers 1.0, 2.0, 3.0 (a) and numbers “00”-“16” (b) do not represent
an absolute length. It simply indicates the relative file position towards the
apical foramen. These numbers are used to help the determination of the
working length.
c. Apical foramen (AP)
The digital number “00” (b) indicate that the file has reached the apical
foramen. The digital numbers “-1” and “-2” (b) indicate that the file has
passed the apical foramen.
Apex locator Operation interface (EAL mode)
a. User Program (M0-M9)
b. Battery level
c. File position indication bar
d. Apical reference point
e. Motor Operation mode

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4. Device operating instructions
4.1 Setting interface and button description
4.2 Power ON and power OFF the device
1. To power ON the device, press the Main button. The device enters in stand-by state.
The display shows the stand-by interface of the last program used. For example:
or or …
2. To start the motor from the stand-by state, press the Main button.
The display shows the working interface according to the program used. For example:
3. To stop the motor, press the Main button again. The device goes back in stand-by state.
4. To power OFF the device, hold down the Setting button “P”, and press the Main button.
In stand-by state, the device will automatically shut down after 5 minutes.
4.3 Select User Programs
The device contains 10 memorized User Programs (M0-M9) and 7 preset FKG File Systems
available directly from the stand-by state.
1. To select a program from the stand-by state, press the Adjusting button “+”/”-“.
… ←→ ←→ … ←→ ←→ ←→
←→ ←→ ←→
←→ ←→ ←→ …
2. To select a specific FKG File System, refer to Chapter 4.5.

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4.4 Set User Program parameters
4.4.1 Warnings
a) Make sure the Operation Mode is adequate before to start the motor.
b) All the parameters must be set according to the file manufacturer recommendations.
c) Make sure all the parameters are verified before to start the motor handpiece.
d) M0-M9 User Programs parameters modified by the user are memorized.
e) FKG File Systems parameters cannot be modified by the user (refer to Chapter 4.5).
4.4.2 Parameter setting
To modify User Program parameters from the stand-by state:
1. To select the desired parameter, press the Setting button “P”.
2. To modify the parameter setting, press the Adjusting button “+”/“-”.
3. Press the Main button or wait 5 seconds to confirm.
4.4.3 User Program parameters list
Set Operation Mode
Operation modes list: CW, CCW, REC, ATR, EAL
(refer to Chapter 3 for modes description)
Set Working Speed
In continuous rotation modes (CW and CCW), the working speed can be adjusted from
100rpm to 3’300rpm (50rpm increments).
In REC mode, the working speed can be adjusted for 100rpm to 500rpm (50rpm
increments).
In ATR mode, the working speed can be adjusted for 100rpm to 500rpm (50rpm
increments).
In REC and ATR modes, the working speed represents the mean speed of one single
angle movement (speed set for both Forward and Reverse angles).
Set Torque Limit
In CW continuous rotation mode, the torque limit can be adjusted from 0.4Ncm to
4.0Ncm depending on the set speed:
•100-200rpm Max torque limit : 4.0Ncm
•250-400rpm Max torque limit : 3.5Ncm
•450-650rpm Max torque limit : 3.0Ncm
•700-950rpm Max torque limit : 2.5Ncm
•1’000-1’450rpm Max torque limit : 2.0Ncm
•1’500-1’950rpm Max torque limit : 1.5Ncm
•2’000-3’300rpm Max torque limit : 1.0Ncm
In REC mode, the torque limit can be adjusted from 2.0Ncm to 4.0Ncm depending on
the set speed:
•100-250rpm Max torque limit : 4.0Ncm
•300-400rpm Max torque limit : 3.5Ncm
•450-500rpm Max torque limit : 3.0Ncm
In ATR mode, the Trigger Torque can be adjusted from 0.4Ncm to 3.0Ncm.
In CCW continuous rotation mode, the torque limit cannot be set.

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Set Apical Action
The Apical action applies when the file reaches the set apical reference point (refer
to Flash Bar Position)
OFF: Disable Apical Action
STOP: The motor stops automatically when the file reaches the reference point. The
motor restarts automatically when the file is pulled away from the reference point.
REVERSE: The motor automatically reverses the rotation direction when the file
reaches the reference point. The motor goes back automatically to initial rotation
direction when the file is pulled away from the reference point.
Set Auto Start
OFF: Disable Auto Start (the Main button is needed to start the motor handpiece).
ON: The motor starts automatically when the file is inserted into the canal (from when
the file progression indicator shows 2 bars).
Set Auto Stop
OFF: Disable Auto Stop (the Main button is needed to stop the motor handpiece).
ON: The motor stops automatically when the file is taken out the canal.
Set Flash Bar Position (Apical reference point)
The apical reference point (flash bar) can be set from 2 to AP (Apical foramen).
(0.5 indicates that the file tip is located very near the physiological apical foramen)
Apical Action and Apical Slow Down are triggered by the apical reference point.
Set Apical Slow Down
When the Apical Slow Down is activated, the motor slows down to a set final speed
as the file tips approaches the apical reference point. The motor speed decreases
starting from the position “3.0” of the file progression indication bar .
OFF: Disable Apical Slow Down
In CW continuous rotation mode, the final speed can be adjusted from 100rpm to the
current set speed (50rpm increments).
The Apical Slow Down function is available for CW & CCW continuous rotation mode
only.
The final speed must be lower than the nominal speed.
Forward Angle
In REC mode, the Forward Angle can be adjusted from 20° to 400° (10° increments)
In ATR mode, the Forward Angle can be adjusted from 60° to 400° (10° increments).
Reverse Angle
In REC mode, the Reverse Angle can be adjusted from 20° to 400° (10° increments)
In ATR mode, the Reverse Angle can be adjusted from 20°to the Forward Angle (10°
increments).

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4.4.4 User Programs parameters availability table
Parameter
User Program
Operation Mode
Set
Working
Speed
Set
Torque
Limit
Set
Apical
Action
Set Auto
Start
Set Auto
Stop
Set Flash
Bar
Position
Set
Apical
Slow
Down
Set
Forward
Angle
Set
Reverse
Angle
CW
YES
YES
YES
YES
YES
YES
YES
n/a
n/a
CCW
YES
NO
NO
NO
NO
YES
YES
n/a
n/a
REC
YES
YES
YES
YES
YES
YES
NO
YES
YES
ATR
YES
YES
YES
YES
YES
YES
NO
YES
YES
EAL
n/a
n/a
n/a
n/a
n/a
YES
n/a
n/a
n/a
4.5 Select FKG File Systems
To help the user set the file parameters according to FKG recommendation, the most popular
FKG File Systems are already preset in the device.
1. To select a preset FKG File System from the stand-by state, long press the Setting button
“P”.
2. To select the desired FKG File System, press the Adjusting button “+”/“-” and press the
Setting button “P” to confirm.
3. To select a file, press the Adjusting button “+”/“-” and press the Main button to confirm.
4.5.1 FKG File Systems list
RACE®EVO
File systems selection
File selection
Stand-by interface
Operation interface
XP-endo®Treatment
File systems selection
File selection
Stand-by interface
Operation interface
XP-endo®Retreatment
File systems selection
File selection
Stand-by interface
Operation interface

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R-Motion®
File systems selection
File selection
Stand-by interface
Operation interface
4.5.2 FKG File Systems parameters availability table
Parameter
FKG File System
Set
Working
Speed
Set
Torque
Limit
Set
Apical
Action
Set Auto
Start
Set Auto
Stop
Set Flash
Bar
Position
Set
Apical
Slow
Down
Set
Forward
Angle
Set
Reverse
Angle
RACE EVO
All Files
YES YES YES YES YES n/a n/a
XP-endo Treatment
Shaper
YES YES YES YES YES n/a n/a
XP-endo Treatment
Finisher
YES YES YES YES YES n/a n/a
XP-endo Retreatment
DR1
YES YES YES YES YES n/a n/a
XP-endo Retreatment
Shaper
YES YES YES YES YES n/a n/a
XP-endo Retreatment
Finisher R
YES YES YES YES YES n/a n/a
R-Motion
All Files
YES YES YES YES NO
4.6 Set device parameters
To set the device parameters:
1. To access the device parameters from the power OFF state, hold down the Setting button
“P” and press Main button.
2. To select the desired parameter, press Setting button “P”
3. To set the parameter, press the Adjusting button “+”/“-” and the Main button to confirm.
4.6.1 Device parameters list
Auto Power OFF
In stand-by state, the device automatically turns OFF after the set timer.
The timer can be adjusted from 3 minutes to 30 minutes (1 minute increments)
Auto Standby Scr
The display switches automatically back to the stand-by interface after the set timer.
The timer can be adjusted from 3 seconds to 30 seconds (1 second increments)
Dominant Hand
The device can be adjusted for left-handed or right-handed user (180° rotation of the
display).

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Calibration
Make sure the original contra-
angle is installed before to launch the motor
calibration.
OFF: No action.
ON: Start motor calibration
The motor must be calibrated before the first use and after lubrification.
Beeper volume
The device sound volume can be adjusted from Vol. 0 to Vol. 4.
Vol.0: Mute.
Restore Defaults
OFF: No action.
ON: Device parameters returns to original setting.
4.7 Torque overload protection
During operation, if the measured torque load exceeds the torque limit, the motor will
automatically reverse the direction of rotation. The motor returns to initial Operation mode (CW)
when the torque load goes back below the torque limit.
4.7.1 Warnings
a) In reciprocation motion mode (REC), when the load value is higher than the torque limit:
i. if the Forward angle is greater than the Reverse angle, the motor automatically
switches to counterclockwise rotation (reverse direction).
ii. if the Reverse angle is greater than the Forward angle, the motor automatically
switches to clockwise rotation (forward direction).
b) The auto-reverse protection is not available for CCW and ATR modes.
c) The auto-reverse protection might not work properly in case of low battery level.
d) Under continuous load, the motor may stop automatically due to overheat. In that case,
the device must be powered OFF enough time to naturally cool down.
4.8 Apex locator limitations
Not all conditions are ideal for root canal length evaluation. Accurate signal cannot be obtained
if the root canal shows the conditions listed below.