FKG Rooter X3000 User manual

User Manual
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Table of Contents
1. Product introducon.................................................................................................... 1
1.1 Descripon of the device............................................................................................................................. 1
1.2 Components and accessories ...................................................................................................................... 2
1.3 Technical specicaons............................................................................................................................... 3
1.4 Warnings ..................................................................................................................................................... 3
1.5 Important precauons ................................................................................................................................ 4
1.6 Device safety classicaon.......................................................................................................................... 4
1.7 Environmental parameters.......................................................................................................................... 4
1.8 User qualicaon ........................................................................................................................................ 4
1.9 Intended use................................................................................................................................................ 4
2. Device setup instrucons ............................................................................................. 4
2.1 Contra-angle setup...................................................................................................................................... 4
2.2 File setup ..................................................................................................................................................... 5
2.3 Apex locator setup ...................................................................................................................................... 6
3. Device Operaon modes and display interface .......................................................... 8
3.1 Motor modes............................................................................................................................................. 8
3.2 Apex locator Operaon mode................................................................................................................... 9
3.3 Combined Motor and Apex locator Operaon mode ............................................................................... 9
3.4 Display interface........................................................................................................................................ 10
4. Device operang instrucons..................................................................................... 11
4.1 Seng interface and bun descripon .................................................................................................. 11
4.2 Power ON and power OFF the device ....................................................................................................... 11
4.3 Select User Programs ................................................................................................................................ 11
4.4 Set User Program parameters ................................................................................................................... 12
4.5 Select FKG FileSystems ............................................................................................................................. 14
4.6 Set device parameters............................................................................................................................... 16
4.7 Torque overload protecon ...................................................................................................................... 16
4.8 Apex locator limitaons ............................................................................................................................ 16
5. Troubleshoong......................................................................................................... 18
6. Cleaning, Disinfecon and Sterilizaon ...................................................................... 18
6.1 Foreword ................................................................................................................................................... 18
6.2 General recommendaons........................................................................................................................ 18
6.3 Step-by-Step Procedure ............................................................................................................................ 19
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7. Maintenance.............................................................................................................. 20
7.1 Calibraon ................................................................................................................................................. 20
7.2 Lubricaon of the contra-angle............................................................................................................... 20
7.3 Charging of the bry ............................................................................................................................. 20
7.4 Replacement of the baery ...................................................................................................................... 20
8. Storage ...................................................................................................................... 21
9. Transportaon ........................................................................................................... 21
10.Environmental protecon .......................................................................................... 21
11.Aer sales service ...................................................................................................... 21
12.Symbol instrucon ..................................................................................................... 21
13.Statement .................................................................................................................. 22
14.EMC-Declaraon of conformity.................................................................................. 23
14.1 Technical Descripon Concerning Electromagnec Emission................................................................... 23
14.2 Technical Descripon Concerning Electromagnec Immunity.................................................................. 23
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1. Product introducn
1.1 Descripon of thedevice
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 preparaon 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 relave poson of the endodonc instrument  inside the canal
(combined Motor and Apex locator mode).
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Contra angle

OLED screen



Charging base
Charging LED indicator

1.2 Components and accessories
# Designaon 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 Protecve silicone cover
08.971.00.009.FK
10 "O"-ring 08.971.00.010.FK
11 Universal AC-Adapter 08.971.00.011.FK
08.971.00.013.FK
08.971.00.014.FK
12 
13 Measuring Wire - USB - C
- User manual -
- Package content list -
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1.Motor handpiece
2.Motor handpiece
3.Contra-angle
4.Spray noozle 6.File clip 
10.O-ring
11.AC-Adapter
7.Lip hook
8.Touch probe
5.Measuring wire

1.3 Technical specicaons
a) Motor handpiece lithium baery speccaon
3.7V / 2000mAh
b) Power adapter specicaon
Input: ~100V-240V50Hz/60Hz 400mA
Output: DC5V/1A
c) Motor handpiece mechanical specicon
Torque range: 0.4Ncm-4.0Ncm
Speed range: 100rpm-3’300rpm
d) Wireless charging specicaon
Frequency range: 112-205KHz
Maximum RF output power of the product: 9.46dBuA/m@3m
1.4 Warnings
Please carefully read this Instrucon Manual before rst operon.
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 recommendaons of the e 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 me.
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 orescent lamps, radio transm devices,
remote control devices, handheld, and mobile high-frequency communicon devices.
j) The motor handpiece, power adapter and charging base are not autoclavable (refer to
Chapter 6).
k) Replace the lithium baery according to the instrucons (refer to Chapter 7.4).
l) Do not make any changes or modicons to the device. Any change, mocaon or any
other alteraon of the device may violate safety regulaons, causing harm to the paent.
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 baery of the device in case of long period storage.
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1.5 Important precauons
These precaons are critical to insure safe operon and use.
a) Do not use this device on paents who have implanted pacemakers, debrillators, or any
other implantable devices.
b) Do not use this device on paents sering from Hemophilia.
c) Use with con on paents with heart disease, pregnant women, and young children.
1.6 Device safety classicaon
a) Type of Operon mode: Couous oper electromedical device
b) Type of protecon against electric shock: Class II equipment with internal power supply
c) Degree of protecon against electric shock: B type applied part
d) Degree of protecon against harmful ingress of water: Ordinary equipment (IPX0)
e) Degree of safety applicaon in the presence of a mmable anesthec mixture with air,
oxygen, or nitrous oxide: Equipment cannot be used in the presence of a mmable
anesthec mixture with air, oxygen, or nitrous oxide.
f) Applied part: contra-angle , lip hook, e clip, touch probe.
The contact duron of applied part: 1 to 10 minutes.
Maximum temperature of applied part: 46.6°C.
1.7 Environmental parameters
a) Opera ambient temperature: +5°C ~ +40°C
b) Opera reve humidity: 30% ~ 75%
c) Opera atmospheric pressure: 70kPa ~ 106kPa
1.8 Userqualicaon
a) The device must be operated in hospital or clinic by legally quaed dests.
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 (endodoc es).
b) In on, it is intended to help to determine the working length (apex locator
funconality).
2. Device setup instrucns
2.1 Contra-angle setup
2.1.1 Before the rst use and er 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 Connec the contra-angle
1. Align the three pins of the contra-angle with the posoning slots of the motor handpiece.
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2. Push the contra-angle horizontally. A “click” sound indicates that the instaon is in
place.
3. The contra-angle must rotate 360° freely.
2.1.4 Disconnecng 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
osc instruments).
b) Connec and disconnec es without holding down the Push buon may damage
the chuck of the contra-angle.
c) Be careful when manipula es to avoid injury to ers.
d) Make sure the e is well connected and locked before to start the motor handpiece.
e) Do not disconnect the le while the motor is running.
2.2.2 Connec a 
Plug the e into the hole of contra-angle head.
1. Hold down the Push buon on the contra-angle and push the e.
2. While pushing, rotate the e clockwise and counterclockwise  its shank is aligned
with the contra-angle latch groove.
3. When the shank is aligned and slips into place, release the Push on to lock the e
into the contra-angle.
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2.2.3 Disconnecng a 
Hold down the Push buon and pull out the e.
2.3 Apex locator setup
2.3.1 Warnings
a) In Apex locator mode, the e clip must properly hold the le.
b) In case of bad or wrong connecon signal, replace the measuring wire.
c) In apex locator mode it is suggested to install the motor handpiece in the charging base
to get beer visual angle.
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d) The Apex locator detects the canal apical foramen, not the tooth anatomical apex. This
could explain some erences between the apex locator signal and an X-ray image.
e) Not all condons are ideal for working length determinaon. To be informed about the
Apex locator limitaons, refer to Chapter 4.8.
2.3.2 Connec 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 e 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 Connecon tes
It is strongly recommended to check the connecon 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 e and check
that all the indicator bars light up, as shown below:
3. Device Operaon modes and display interface
3.1 Motor modes
3.1.1 CW Operaon Mode (Clockwise conous rotaon mode)
In this mode, the motor handpiece rotates in clockwise direcon only (forward direcon).
3.1.2 CCW Operaon Mode (Counterclockwise conuous rotaon mode)
In this mode, the motor handpiece rotates in counterclockwise direcon only (reverse direcon).
In this mode, a double beepsounds coously.
3.1.3 REC Operaon Mode (Reciproca moon mode)
In this mode, the motor handpiece generates reciproca moon only (F: Forward angle, R:
Reverse angle).
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3.1.4 ATR Operaon Mode (Ave Torque Reverse mode)
In this mode, the motor handpiece rotates in clockwise direcon and generates reciprocag
moon when the torque load on the e is higher than the set torque limit.
3.2 Apex locator Operaon mode
3.2.1 EAL Operaon Mode (Electronic Apex Locator)
This mode is intended for working length determon only.
In this mode, the motor handpiece does not run.
3.3 Combined Motor and Apex locator Operaon mode
When a e is inside the canal and the lip hook is in contact with ent’s lip, the device enters
automacally 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 sengs of the
motor.
a. User Program (M0-M9)
or
Manufacturer preset program (refer to Chapter 4.5)
b. ry level
c. Set speed (rpm)
d. Set torque limit (Ncm)
e. Motor Operaon mode
f. Set forward angle (°deg)
g. Set reverse angle (°deg)
Motor Operaon interface
While the motor is running, the display shows the torque load on the e.
a. Set speed (rpm)
b. Set torque limit (Ncm)
c. Real me torque (Ncm)
d. Torque display scale (Ncm)
Combined Motor and Apex locator Operaon interface
a. Fileprogression indicaon bar
b. File progression indicaon 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 relae le posion towards the
apical foramen. These numbers are used to help the determinaon of the
working length.
c. Apical foramen (AP)
The digital number “00” (b) indicate that the e has reached the apical
foramen. The digital numbers “-1” and “-2” (b) indicate that the e has
passed the apical foramen.
Apex locator Operaon interface (EAL mode)
a. User Program (M0-M9)
b. ry level
c. File posion indicaon bar
d. Apical reference point
e. Motor Operaon mode
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XP-endo T.
Shaper
f
g

4. Device operang instrucons
4.1 Seng interface and bon descripon
4.2 Power ON and power OFF thedevice
1. To power ON the device, press the Main on. 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 on.
The display shows the working interface according to the program used. For example:
3. To stop the motor, press the Main on again. The device goes back in stand-by state.
4. To power OFF the device, hold down the Seng on “P”, and press the Main on.
In stand-by state, the device will automacally shut down er 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 Adjuson “+”/”-“.
…  …   
  
   …
2. To select a specc FKG File System, refer to Chapter4.5.
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XP-endo T.
Shaper 1000rpm
1.0Ncm
XP-endo T.
Shaper 1000rpm
1.0Ncm
XP-endo T.
Finisher 1000rpm
1.0Ncm
RACE EVO
All files 1000rpm
1.5Ncm
XP-endo R.
DR1 1000rpm
1.5Ncm
XP-endo R.
Finisher R 1000rpm
1.0Ncm
XP-endo R.
Shaper 2500rpm
1.0Ncm
R-Motion
All files F: auto
REC R: auto
R-Motion
All files F: auto
REC R: auto
250rpmM9
CW 2.0Ncm

4.4 Set User Program parameters
4.4.1 Warnings
a) Make sure the Operaon Mode is adequate before to start the motor.
b) All the parameters must be set according to the e manufacturer recommendaons.
c) Make sure all the parameters are vered before to start the motor handpiece.
d) M0-M9 User Programs parameters moed by the user are memorized.
e) FKG File Systems parameters cannot be modied by the user (refer to Chapter 4.5).
4.4.2 Parameter se
To modify User Program parameters from the stand-by state:
1. To select the desired parameter, press the Seng on “P”.
2. To modify the parameter se press the Adjus on “+”/“-”.
3. Press the Main on or wait 5 seconds to conrm.
4.4.3 User Program parameters list
Set Operaon Mode
Operaon modes list: CW, CCW, REC, ATR, EAL
(refer to Chapter 3 for modes descripon)
Set Working Speed
In connuous rotaon 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 connuous rotaon 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 connuous rotaon mode, the torque limit cannot be set.
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Operation Mode
CW
Speed
250rpm
Torque Limit
1.0Ncm

Set Apical Acon
The Apical acon applies when the e reaches the set apical reference point (refer
to Flash Bar Posion)
OFF: Disable Apical Acon
STOP: The motor stops automacally when the e reaches the reference point. The
motor restarts automacally when the e is pulled away from the reference point.
REVERSE: The motor automacally reverses the rotaon direcon when the e
reaches the reference point. The motor goes back automacally to inial rotaon
direcon when the e is pulled away from the reference point.
Set Auto Start
OFF: Disable Auto Start (the Main buon is needed to start the motor handpiece).
ON: The motor starts automacally when the e is inserted into the canal (from when
the le progression indicator shows 2 bars).
Set Auto Stop
OFF: Disable Auto Stop (the Main buon is needed to stop the motor handpiece).
ON: The motor stops automacally when the e is taken out the canal.
Set Flash Bar Posion (Apical reference point)
The apical reference point (ash bar) can be set from 2 to AP (Apical foramen).
(0.5 indicates that the e p is located very near the physiological apical foramen)
Apical Acon and Apical Slow Down are triggered by the apical reference point.
Set Apical Slow Down
When the Apical Slow Down is acvated, the motor slows down to a set nal speed
as the e ps approaches the apical reference point. The motor speed decreases
starng from the posion “3.0” of the file progression indicaon bar .
OFF: Disable Apical Slow Down
In CW connuous rotaon mode, the nal speed can be adjusted from 100rpm to the
current set speed (50rpm increments).
The Apical Slow Down funcon is available for CW & CCW connuous rotaon mode
only.
The nal 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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Apical Slow Down
200rpm

4.4.4 User Programs parameters availability table
Parameter
User Program
Operaon Mode
Set
Working
Speed
Set
Torque
Limit
Set
Apical
Acon
Set Auto
Start
Set Auto
Stop
Set Flash
Bar
Posion
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 e parameters according to FKG recommendaon, 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 Se buon
“P”.
2. To select the desired FKG File System, press the Adjus on “+”/“-” and press the
Se on “P” to corm.
3. To select a le, press the Adjus bon “+”/“-” and press the Main on to corm.
4.5.1 FKG File Systems list
RACE®EVO
File systems selecon
File selecon
Stand-by interface
Operaon interface
XP-endo®Treatment
File systems selecon
File selecon
Stand-by interface
Operaon interface
XP-endo®Retreatment
File systems selecon
File selecon
Stand-by interface
Operaon interface
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XP-endo T.
Shaper 1000rpm
1.0Ncm
XP-endo T.
Shaper 1000rpm
1.0Ncm
XP-endo R.
DR1 1000rpm
1.5Ncm
XP-endo R.
Shaper 2500rpm
1.0Ncm
XP-endo R.
Finisher R 1000rpm
1.0Ncm
RACE EVO
All files 1000rpm
1.5Ncm
2500rpm 1000rpm 1000rpm
DR1
Shaper
Finisher R
CW
1000rpm
1.0Ncm
Finisher R
DR1
Shaper
Finisher R
CW
2500rpm
1.0Ncm
Shaper
DR1
Shaper
Finisher R
CW
1000rpm
1.5Ncm
DR1
Shaper
Shaper
CW
1000rpm
1.0Ncm
Finisher
Shaper
Finisher
CW
1000rpm
1.0Ncm
Shaper
CW
1000rpm
1.5Ncm
All files

R-Moon®
File systems selecon
File selecon
Stand-by interface
Operaon interface
4.5.2 FKG File Systems parameters availability table
Parameter
FKG File System
Set
Working
Speed
Set
Torque
Limit
Set
Apical
Acon
Set Auto
Start
Set Auto
Stop
Set Flash
Bar
Posion
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-Moon
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 Se on
“P” and press Main buon.
2. To select the desired parameter, press Se on “P”
3. To set the parameter, press the Adjus on “+”/“-” and the Main on to conrm.
4.6.1 Device parameters list
Auto Power OFF
In stand-by state, the device automacally turns OFF r the set mer.
The mer can be adjusted from 3 minutes to 30 minutes (1 minute increments)
Auto Standby Scr
The display switches automacally back to the stand-by interface r the set mer.
The mer can be adjusted from 3 seconds to 30 seconds (1 second increments)
Dominant Hand
The device can be adjusted for l-handed or right-handed user (180° rotaon of the
display).
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Software Version
V1.0.0
R-Motion
All files F: auto
REC R: auto
--rpm
REC
auto
auto
All files

Calibraon
Make sure the original contra-angle is installed before to launch the motor
calibraon.
OFF: No acon.
ON: Start motor calibraon
The motor must be calibrated before the rstuse and aer lubricaon.
Beeper volume
The device sound volume can be adjusted from Vol. 0 to Vol. 4.
Vol.0: Mute.
Restore Defaults
OFF: No acon.
ON: Device parameters returns to original seng.
4.7 Torque overload protecon
During operon, if the measured torque load exceeds the torque limit, the motor will
automacally reverse the direcon of roon. The motor returns to  Operaon mode (CW)
when the torque load goes back below the torque limit.
4.7.1 Warnings
a) In reciprocaon moon 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 automacally
switches to counterclockwise rotaon (reverse direcon).
ii. if the Reverse angle is greater than the Forward angle, the motor automcally
switches to clockwise rotaon (forward direcon).
b) The auto-reverse protecon is not available for CCW and ATR modes.
c) The auto-reverse protecon might not work properly in case of low baery level.
d) Under connuous load, the motor may stop automacally due to overheat. In that case,
the device must be powered OFF enough me to naturally cool down.
4.8 Apex locator limitaons
Not all condons are ideal for root canal length evaluaon. Accurate signal cannot be obtained
if the root canal shows the condions listed below.
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Rootcanal with a large apical foramen
Root canal with exceponally large apical foramen due
to a lesion or incomplete development might disturb the
electrical signal.
Rootcanal with liquid overowing from the opening
Root canal with blood or any other liquid overowing
from the opening and in contact with the gingival ssue
might disturb the electrical signal.
Broken crown
If the crown is broken and a secon of the gingival ssue
intrudes into the cavity surrounding the canal opening,
the contact between the gingival ssue and the le might
disturb the electrical signal.
Fractured tooth
Fractured tooth might disturb the electrical signal.
Re-treated root canal led with gua-percha
Debris of gua-percha might disturb the electrical signal.
Crown or metal prosthesis touching gingival ssue
The contact between the prosthesis and the le might
disturb the electrical signal.
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