Dentsply Maillefer X-SMART User manual

NVG / F190294X / 06 / 2007–updated 08/2009 - 1 / 148 -
COMBINED MOTOR-APEX LOCATOR
User Manual

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CONTENTS
English ……………………………………………..……… 2
Français …………………………………………………… 29
Deutsch ………………………………………….………… 59
Español ……………………………………….…………… 89
Italiano …………………………………………..………… 119
Português. Este manual de utilização está também disponível, quando
requisitado, nas seguintes línguas: português, holandês, dinamarquês,
sueco, finlandês, grego ePolacos.
Nederlands. Deze gebruiksaanwijzing is, op aanvraag, eveneens verkrijgbaar
in de volgende talen: Portugees, Deens, Zweeds, Fins, Grieks enPools.
Suomi. Käyttöohje on saatavana myös seuraavilla kielillä: portugali, hollanti,
tanska, ruotsi, suomi kreikka japuola.
Svenska. Denna bruksanvisning finns även att tillgå på följande språk:
portugisiska, hollandska, danska, svenska, finska grekiska ochpolska.
Dansk. Denne brugsanvisning kan også rekvireres på følgende sprog:
portugisisk, hollandsk, dansk, svensk, finsk græsk og polsk.
Ελληνική. Αυτήηοδηγίαείναιεπίσηςδιαθέσιµη,κατόπινζήτησης,στιςακόλουθες
γλώσσες:Πορτογαλέζικη, Oλλaνδική,∆ανέζικη,Σουηδική,Φιλανδέζικη,Ελληνικήκαι.
Πολωνική.
Polski. Ta instrukcja obsługi jest równieżdostępna, na zamówienie, w
następujących wersjach językowych: portugalski, holenderski, duński,
szwedzki, fiński, grecki i polski.
Visit our website: www.dentsplymaillefer.com

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Table of contents
Introduction 3
1. Indicationsfor use 3
2. Contraindications 4
3. Warnings. 4
4. Precautions 5
5. Adverse reactions 6
6. Step by step instructions 7
A. Contents 7
B. Recharging the battery 8
C. How to connect each part 8
D. Operation panel 10
E. LCD panel 11
F. Power 12
G. Operating mode selection 13
H. Settings 15
I. Torque calibration 15
J. Functional check of the apex locator 16
K. Cleaning, disinfection and sterilization 17
L. Maintenance 19
M. Error code 21
N. Troubleshooting 22
O. Warranty 23
P. Disposal of the product 24
Q. Technical specifications 24
R. Standard symbols 25
Appendix
Electromagnetic emissions and immunity 26

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For dental use only
Introduction
Congratulations on the purchase ofX-SMARTTM Dual.
Read this Operation Manual carefully before use for operation instructions, care and
maintenance. Keep this Operation Manual for future reference.
1. Indications for use
X-SMARTTM Dual is a combined device incorporating a microprocessor controlled
endodontic micromotor for operating NiTi instruments and an apex locator to determine
the position of the apex and thus the working lengthof the root canal.
The device can be operated in three different modes : Motor only, apex locator only or as
a combined unit (Dual mode) when the apex location function drives the endo-motor.
The rotational speed is held constant for all loads until the maximum preset torque is
achieved. The torque protection or Automatic Torque Control (ATC) reduces the risk of file
breakage: Once the preset torque is reached, the motor immediately reverses.

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The X-SMARTTM Dual S is a variant of the X-SMARTTM Dual with a few functions not
available in Dual mode:
No automatic start of the motor when the file is inserted into the root canal
No automatic stop when the file is withdrawn from the root canal
To start and stop the motor, use the On/Off button on the handpiece
No automatic reverse of the motor when the apex is reached
The version of the device is indicated on the label located at the bottom of the unit.
This product must be used by qualified dental personnel in the appropriate environments;
clinics or dental offices.
We recommend the removal of debris by abundant rinsing. Remove excess solution
contained in the pulp chamber and lubricate each instrument with Glyde.
2. Contraindications
In cases where a patient has been fitted with an implanted heart pacemaker (or other
electrical equipment) and has been cautioned against the use of small electrical
appliances (such as electric shavers, hair dryers etc.), the devicecannot be used.
This device should not be used for severely curved root canal preparation.
Do not use the device for implants or any other dental procedure outside endodontics.
3. Warnings
Confirm that the operating voltage and the mains voltage are compatible.
All sterilizable parts must be sterilized prior to initial use (See Chapter K Cleaning,
disinfection and sterilization).
Use the specified battery for this product. Never use a battery other than those
specified by Dentsply Maillefer.
Use the Dentsply Maillefer AC adapter for this product. Never use any other AC
adapters.
Do not disassemble or alter the motor handpiece.
Do not expose the unit, motor handpiece or battery charger to any liquid.
If you should notice battery fluid leaking, deformation of the motor handpiece
casing or partial discoloring, immediately stop use and contact your distributor.
The system may present the possibility of malfunction when used in the presence
of an electromagnetic interference wave. Do not install the system in the vicinity of
a device which emits magnetic waves.

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Do not use in the presence of flammable products. The device is not suitable for
use in the presence of a flammable anesthetic mixture with air or with oxygen or
nitrous oxide.
Do not use a bent, damaged, deformed or non-ISO-conforming file. Using such a
file may result in personal injury due to unexpected file breakage or detachment
from the handpiece during rotation.
This motor is equipped with an electronic circuit to limit file breakage. Nevertheless,
files may still break due to higher torque conditions or to fatigue resistance.
Should the leaked battery fluid get into your eyes, immediately wash eyes
thoroughly with clean water and see your doctor. Failure to do so may result in loss
of sight.
Should the battery fluid leak onto skin or clothing, immediately wash the exposed
skin thoroughly with clean water and completely wash away the fluid. Failure to do
so may result in skin complications.
Use of portable phones or other radio frequency (RF) emitting equipment near the
product may cause unexpected or adverse operation.
The product shall not be used adjacent to, or stacked with, other equipment. If
adjacent or stacked use is necessary, the product shall be tested to verify normal
operation in the configuration in which it is being used.
The use of accessories, transducers and cables other than those specified may
result in increased emissions or decreased immunity performance of the product.
The manufacturer claims EMC compliance for the following items: Motor
Handpiece max length 2.0m; Switching Power Supply max length 1.8m
4. Precautions
The appliance must only be used with the manufacturer's original accessories.
If the motor stops or runs too fast, discontinue use and call for assistance.
Do not introduce any oil into the micromotor.
The system functions normally in the environment where the temperature is at
10 - 40 ˚C (50 - 104 ˚F), humidity at 10 - 85% RH, atmospheric pressure at 500-
1060hPa, and no moisture condensation in the Control Unit. Any use outside these
limits may cause malfunction.
It is recommended to use rubber dam when performing endodontic treatment.
Excessive conductive fluid forms a conductive bridge between root canals or with
metallic restorations or crowns. It is recommended to dry the pulp chamber to have
accurate measurement.
Check the product before use by rotating it, paying attention to looseness,
vibration, noise and temperature (heat generation). If any abnormal condition is
found even slight, at that time, immediately stop use and contact your distributor.

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Always clean the shank of the file to be installed. Allowing dirt to enter the chuck
could cause loss of concentricity and deterioration of chucking force.
Before changing the contra angle or the instrument (file), turn off the power of the
motor handpiece. Changing with the power on may cause unintended rotation by
accidental touch of the ON/OFF button.
For your own safety, please wear personal protective equipments (gloves, glasses,
mask).
If you do not use the product for a long period of time, remove the battery to avoid
fluid leak.
Confirm the battery has been inserted in the proper direction. Insertion in the wrong
direction may cause damage and fluid leakage due to a short circuit.
During operation, make sure there is always contact between the file and the fork.
Otherwise the apex position cannot be determined (Apex locator or dual modes).
Prior to the use of dual mode (Motor and apex locator), it is recommended to
determine the working length using the apex locator mode of the device only.
Notice
Fully-charged rechargeable batteries generally discharge gradually over time even
though the motor handpiece is not used. It is recommended to recharge the battery
just before use.
Should the product not be in use over an extended period of time (approximately 1
month), we recommend disconnecting the battery (See Chapter L. Maintenance for
instructions on inserting and removing the battery).
When the motor handpiece stops automatically by detecting a low battery voltage,
turning on the power again after a while may not detect the low voltage
immediately. This is not a failure, but is due to battery characteristics. Since the
voltage drop does not coincide with the remaining battery capacity, consider it only
as a benchmark.
When discarding the contra angle and motor handpiece, dispose of them as
medical waste.
Users are responsible for operational control, maintenance and inspection.
Storage conditions:
- Temperature: - 10 to 60˚C (14 to 140˚F)
- Humidity: 10 to85% RH
- Atmospheric pressure: 500to 1060 hPa
- The system should not be subject to air with dust, sulphur or salinity
5. Adverse reactions
None known.

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6. Step-by-step instructions
A. Contents
Before use, please check the exact contents of the new equipment:
1. One unit
2. One charger with AC cable
3. One motor handpiece
4. One contra angle
5. One connection part with contact fork (removable from the contra angle)
6. One handpiece stand
7. Two lip clips
8. One tester for the apex locator
9. One measurement cable and two connection hooks
One user manual
One torque card
6
2
7
7
3
4
1
9
8
5

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B. Recharging the battery
The device is delivered with a rechargeable battery.
Procedure for recharging the battery:
1. Connect the AC cable to the charger
2. Connect the charger cable to the right side of unit
3. Connect the charger to the main power source
4. The AC/DC and the battery charge status symbolsare indicated on the screen
5. The AC-IN lamp lightsin green and the CHRG lamp lights in orange
6. When the CHRG lamp turns off, charging has been completed.
7. The AC/DC and the battery charge status symbols are indicated on the screen
Duration of charging:Depending of the battery charge level, up to 3 hours.
Note: The unit can be operated on battery or electrical power (while battery is charging) in
motor and dual modes. In apex locator mode, when using the apex locator accessory set,
the unit can only be operated on battery power.
C. How to connect each part
1. Connect the motor handpiece or the measurement cable on the front of the unit:
Align the  mark of the cord plug with the mark of the unit connector and
insert the plug until it locks.
NOTICE: To remove the plug, hold the plug ring and pull it down.
2. Connect the contra angle to the motor handpiece until it locks and check the
connection by gently pulling in the opposite direction.
LCD panel indications Operation panel indications

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3. Insert the file into the contra angle:
Insert the file into the chuck until it stops
Lightly turn the file until it engages with the latch mechanism. Push inward to
click
CAUTION: During operation, make sure there is always contact between the file
and the fork. Otherwise the apex position cannot be determined
(Apex locator or dual modes).
NOTICE: To remove the file, press on the push button.
4. Insert the lip clip in the lip clip connector. Attach the lip clip to the patient for apex
locator function or dual mode.
The device is now operational.
NOTICE: The unit can also be used as an apex locator only. In this case, the
working length determination can be achieved using the regular
handpiece or connecting the measuring cable on the front of the unit.

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D. Operation panel
A. POWER Switches device on and off (keep pressed for
ON/OFF button approx. 1.5 sec.)
B. MEMO Saves the settings from the program currently selected
Saving
C. MODE Select mode:
Operating mode Motor only Apex Locator only Combo unit
D. AUTOREV Select one of the 3 auto reversemodes:
Auto reverse mode X-SMARTTM Dual:
Motor automatically reverses when the preset torque
is reached or when the apex is reached
Motor automatically reverses when the preset torque
is reached or automatically stops when the apex is
reached
Auto reverse mode not activated
X-SMARTTM Dual S:
Motor automatically reverses when the preset torque
is reached
Motor automatically reverses when the preset torque
is reached or automatically stops when the apexis
reached
Auto reverse mode not activated
A
C
H
G
F
I
J
BD E

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E. REV Press this key to reverse the direction of the motor
Reverse
F. SPEED +/- Adjust speed with (+) or (-) buttons from 100 to 800 rpm
Motor speed
G. TORQUE +/- Adjust torque with (+) or (-) buttons from 0.6 to 4 Ncm
Torque By pressing the button one again, you reach the maximum
torque (about 5.5 Ncm)
H. PROGRAM +/- Select required program with (+) or (-) buttons from
Program selection 1 to 9
Sound volume Press both (+) and (-) buttonsfor approx. 1 secondto
adjust the sound volume
I. CHRG
LED indicator (orange) Lights when battery is charging
J. AC-IN
LED indicator (green) Lights when main adapter is connected
E. LCD panel
NOTICE: Display appearance when fully illuminated.

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Only for X-SMART
TM
Dual version:
Motor reverses
- if a preset torqueis reached
- if the Apex is reached
Motor reverses if a preset torque is reached
Motor stops if the Apex is reached
Reverse rotation
Battery empty
Approx. 25 % battery capacity remaining
Approx. 50 % battery capacity remaining
Approx. 75 % battery capacity remaining
Full charge
Unit is connected to the main power source
Sound control: Maximum volume
Sound control: Low volume
Sound control: Mute
F. Power
1. Holding down the POWER key for more than 1.5 second, turns on the power
and LCD panel lights.
2. Holding down the POWER key for more than 1.5 second, while the power is
on, turns off the power and LCD display.
NOTICE: The unit automatically switches off after 10 minutes without operation.

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G. Operating mode selection
One of the three possible operating modes is selected with the MODE button on
the operating panel:
1. Motor only (without apex locator)
The motor is started and stopped with the ON/OFF key on the
handpiece.
Display indications: Program number / Rotational speed / Torque
No indication on the right part of the display
2. Apex locator only (without motor)
File progression down to the apex is displayed.
Display indications: See next page for apex determination
Note: The unit can only be operated on battery power when using
the apex locator accessory set.
3. Motor / Apex locator (Dual mode)
X-SMARTTM Dual unit:
The motor starts automatically if the file is inserted into the root
canal and stops when the file is withdrawn from the canal.
X-SMARTTM Dual S unit:
The motor is started and stopped with the ON/OFF key on the
handpiece.
Display indications: Program number (A is indicated during the
two first seconds) / Rotational speed / Torque
See next page for apex determination

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4. Display information during working length determination
First segment flashes: The unit is ready for apex determination.
As soon as the file makes contact with the root canal, the first
segment lights up continuously and the second segment starts to
flash. An acoustic signal also sounds.
If the dual mode is active, the motor automatically starts (not
available for X-SMARTTM Dual S unit).
With further progression of the file in the root canal, the numerical
value on the graphical scale changes. The unit emits audible
information of file progression via progressive rate beeps.
The apical zone is reached.
The apex is reached. If the dual mode is active :
- For X-SMARTTM Dual unit, the motor automatically reverses or
stops depending on the selected auto reverse mode.
- For X-SMARTTM Dual S unit, the motor automatically stops.
Withdraw the file from the canal.
The file has passed the apex.
“OVER” on the display lights in red, and an acoustic warning
signal sounds at the same time.
The file must be immediately withdrawn from the canal.
NOTICE: The apex determination can be made using the micromotor handpiece
or using the apex locator accessory set.
In both cases, do not forget to connect the lip clip to the patient prior to measurement.
Occasionally, the graphical scale will make a sudden drop as soon as the file is
inserted into the root canal, but it will return to normal state as the file is advanced
down towards the apex.

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H. Settings
This product is programmed in advance with 1 to 9 programs according to various files to
be used. You can change any preset values and have them saved to your desired settings
(operating mode, rotation speed, torque limit value, auto reverse mode).
1. Press the PROGRAM key until it turns to the program number which you want to
memorize.
2. Adjust the values or modes by each key according to your needs.
3. Hold down the MEMO key button for more than 1.5 seconds to save settings.
I. Torque calibration
This function is used to decrease fluctuation in the rotation speed of the motor handpiece
and the difference in torque by the contra angle.
The motor handpiece calibration is recommended when using a new contra angle or after
an extended period of operation, as the running properties can change with usage,
cleaning and sterilization.
Calibration procedure:
1. Lubricate the contra angle with the X-SMART TM spray.
2. Attach the contra angle head to the motor handpiece.
3. Connect the AC adapter if the battery capacity remaining is 25% or less.
4. Turn on the power.
5. Hold down both buttons of the SPEED simultaneously for more than one second.
6. The calibration starts and LCD panel display indicates :
The calibration procedure runs automatically.
The torque of the non-loaded contra angle is
measured at six different speeds.
The procedure is completed once the counter has
counted back to “00” in the “TORQUE” field.
7. The motor handpiece begins to rotate : leave it as it is until it stops.
8. This process ends, if the rotation stops and the LCD panel display returns to its
original state.
NOTICE: Do not touch or apply a load to the rotating shaft of the contra angle
head : it obstructs.

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J. Functional check of the apex locator
It is recommended to check the performance of the Apex Locator once a week.
Functional check procedure:
1. Unplug the motor cable.
2. Insert the tester into the connector of the front of the unit.
3. Switch on the unit.
4. Select “Apex locator only” or “Dual” operating mode.
5. Check that the graphical scale indicates within ± 2 bars away from 0.5.
CAUTION: If the reading is 3 or more bars away from 0.5, the unit will not make
accurate measurements. In this case, please contact your distributor.
6. Remove the tester.
7. Connect the motor handpiece equipped with a file and the connection part with
contact fork or the measurement cable.
8. Touch the file or the hook with the lip connector.
9. Check that all the canal length indicator bars on the display are lit and OVER
warning lights with the acoustic signal.
CAUTION: If this does not happen, please refer to chapter N Troubleshooting.

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K. Cleaning, disinfections and sterilization
Foreword
The Lip clip, the hook, the contra angle and its connection part with contact fork must be
cleaned, disinfected and sterilized before each use to prevent any contamination
according to ISO 17664. This concerns the first use as well as subsequent uses.
General recommendation
●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.
●For your own safety, please wear personal protective equipment (gloves, glasses,
mask).
●Use only a disinfecting solution which is approved for efficacy (DGHM-listing, CE
marking, FDA approval)
The micromotor handpiece, the control unit, the measurement cable, the charger and the
AC cable must not be sterilized.
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).
Procedure
For Lip clip, Hook, Contra angle and its connection parts with the contact fork
Operation Operating mode Warning
1. Pre-Disinfection or
Decontamination - Soak immediately after usage all instruments in a disinfectant
solution combined with proteolytic
enzyme if possible.
- Follow instructions and observe concentrations
and immersion time given by the manufacturer
(an excessive concentration may cause
corrosion or other defects on instruments).
- The disinfectant solution should be aldehyde
free (to avoid blood impurities fixation).
- Do not use adisinfectant solution containing
Phenol or any products which are not
compatible with the instruments (See general
recommendation).
- For visible impurities that are observed on
instruments, a pre-cleaning is recommended by
brushing them manually with soft material.
X
2. Rinsing - Rinse the accessories with
current water manually and
abundantly X
3. Manual Cleaning - Clean the accessories with an
adequate brush manually,
preliminary soaked in a clean
pre-disinfectant solution
- The hook mechanism has to be
activated during the cleaning
process (press the push button
several time) in order to ensure a
good cleaning
- No visible impurities should be observed on the
accessories
X
4. Rinsing See point # 2 x

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Operation Operating mode Warning
5. Disinfection - Immerse the accessories in a
disinfectant solution (bactericidal,
virucidal, fungicidal,
tuberculocidal and aldehyde free)
according to the manufacturer’s
recommendations
- Follow instructions and observe concentrations
andsuggested times given by the manufacturer x
6. Final rinsing - See point # 2
- After rinsing, the accessories
must be dried. X
7. Inspection - Inspect devices and sort out
those with defects.
- Dirty instruments must be
cleaned and disinfected again. X
8. Packaging - Pack the devices in “Sterilization
pouches”. - Check the validity period of thepouch given by the manufacturer to determine the shelf life.
- Use packaging whichis resistant to a
temperature up to 141°C (286°F) and in
accordance with EN ISO 11607.
X
9. Sterilization - Steam sterilization at:
134°C (274°F) for18 min - The Lip clip, Hook, Contra angle and its connection parts with contact fork must be
sterilized according to the packaging labelling.
- Use fractionated vacuum or(less preferred)
gravity autoclaves (according to EN 13060, EN
285).
- Use validated sterilizationprocedure according
to ISO 17665-1
- Use the maintenance procedure of the
autoclave device given bythe manufacturer.
- Use onlythe listed sterilization procedures.
X
10. Storage - Keep devices in sterilization
packaging in a dry and clean
environment
- Sterilitycannot be guaranteed if packaging is
open, damaged or wet (check the packaging
before using the instruments). X
Contra angle lubrication
Lubricate the contra angle head only by using the X-SMART TM spray
Insert the spray nozzle into the rear part of the contra angle head and lubricate the
head for 2-3 seconds.
CAUTION:
Do not lubricate the motor section of the motor handpiece.
To clean the motor handpiece, do not use any solvent such as benzene and/or a
thinner.
Before mounting the lubricated contra angle to the motor handpiece, wipe off extra
oil. Stand it on its end or lean it in the proper position for gravity draining. Mount it
after excess oil has been drained.
Hold the contra angle securely to prevent it from detachment caused by the
pressure of the spray.
Supply lubricant until it comes out of the handpiece head (for approx. 2 seconds).
Do not use a spray can upside down as only spray gas will be dispensed without
oil.

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Handpiece dismantling
Remove the file.
Disconnect the motor handpiece from the unit.
Remove the contra angle from the motor handpiece by pulling it out axially.
Remove the connection part with contact fork by pulling it down and sliding it in the
direction of the arrow.
L. Maintenance
1. Changing the battery
The device uses rechargeable batteries. It can be recharged up to 500 times,
depending on the conditions of the motor handpiece.
If the operating time or recharging time becomes shorter or the rotation power
becomes weaker, the life of the battery is suspect.
In such a case, replace the battery. When replacing, be sure to observe the
following “ CAUTIONS ON CHANGING BATTERY”. Note that Dentsply Maillefer
shall not be held liable for any malfunction or failure resulting from your not
following the “ CAUTIONS ON CHANGING BATTERY”.
CAUTIONS ON CHANGING THE BATTERY
Do not open any part other than the battery cover.
Be sure to purchase and use only the recommended battery. Otherwise,
battery may cause damage, fluid leakage or explode.
Do not work with wet hands. This may cause trouble due to short-circuiting of
the battery and moisture infiltrating the product.