Dentsply Maillefer X-SMART Plus User manual

USER MANUAL

FISDR-JAP / F1902124.X / 00 / 2011 – created 07/2011 - 3 / 208 -
CONTENTS
English 5
Français 43
Deutsch 85
Español 125
Italiano 165
Português
Este manual de utilização está também disponível, quando requisitado, nas seguintes
línguas: Português (POR), Holandês (NL), Dinamarquês (DK), Sueco (S), Finlandês
(FIN), Grego (GR), Polacos (POL) Letónia (LV), Estónia (EE) e Lituânia (LT)..
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Pools (POL), Lets (LV), Ests (EE) en Litouws (LT).
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(POR)
, hollanti
(NL)
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Holländska (NL), Danska (DK), Svenska (S), Finska (FIN), Grekiska (GR), Polska
(POL), Lettiska (LV), Estniska (EE) och Litauiska (LT).
Dansk
Denne
brugsanvisning kan også rekvireres på følgende sprog: Portugisisk (POR),
Hollandsk (NL), Dansk (DK), Svensk (S), Finsk (FIN) græsk (GR) Polsk (POL), Lettiske
(LV), Estiske (EE) og Litauiske (LT).
Ελληνική
Αυτή
η
οδηγία
είναι
επίσης
διαθέσι
µ
η
,
κατόπιν
ζ
ήτησης
,
στις
ακόλουθες
γλώσσες
:
Πορτογαλέζικη (POR), Oλλaνδική (NL), ∆ανέζικη (DK), Σουηδική (S), Φιλανδέζικη
(FIN), Ελληνική (GR) Πολωνική (POL), Λετονίας (LV), Εσθονίας (EE) και Λιθουανίας
(LT).
Polski
Ta instrukcja obsługi jest również dostępna, na z
amówienie, w następujących wersjach
językowych: Portugalski (POR), Holenderski (NL), Duński (DK), Szwedzki (S), Fiński
(FIN), Grecki (GR), Polski (POL), Łotewski (LV), Estoński (EE) i Litewski (LT).
Lietuviųk.
Šį instrukcijų vadovą pagal užklausą gali
ma gauti ir šiomis kalbomis: Portugalų
(POR)
,
Olandų (NL), Danų (DK), švedų (S), Suomių (FIN), Graikų (GR) Latvių k (LV), Estų k.
(EE) ir Lietuvių k. (LT) .
Latviešu
Šī rokasgrāmata pēc pieprasījuma ir pieejama arī šādās valodās: Portugāļu
(POR)
,
Holandiešu (NL), Dāņu (DK), Zviedru (S), Somu (FIN), Grieķu (GR), Poļu (POL),
Latviešu (LV), Igauņu (EE) un Lietuviešu (LT) valodās.
Eesti
See juhend juhend on saadaval ka taotluse korral järgmistes keeltes: Portugali (POR),
Hollandi (NL), Taani (DK), Rootsi (S), Soome (FIN), Kreeka (GR), Poola (POL), Läti (LV)
ja Eesti (EE) ja Leedu (LT).

FISDR-JAP / F1902124.X / 00 / 2011 – created 07/2011 - 4 / 208 -

FISDR-JAP / F1902124.X / 00 / 2011 – created 07/2011 - 5 / 208 -
USER MANUAL
Table of Contents
Introduction 7
1. Indications for Use 8
2. Contraindications 8
3. Warnings 8
4. Precautions 10
5. Adverse Reactions 11
6. Step-by-Step Instructions 11
6.1. Standard Components 12
6.2. Operation Panel 13
6.3. LCD Panel 15
6.4. Preparation 17
6.5. Installation 17
6.5.1. Connecting the AC adapter 17
6.5.2. Connecting and Disconnecting the Motor Handpiece 18
6.5.3. Connecting and Disconnecting the Contra-angle 19
6.5.4. Inserting and Removing the File 19
6.5.5. Charging the Battery 20
6.5.6. Calibration 21
6.5.7. Sound Volume Adjustment 22
6.6. Operation 22
6.6.1. File Library 22
6.6.2. Switch-on and Switch off the Unit 23
6.6.3. Switch-on and Switch off the Motor Handpiece 23
6.6.4. Auto Reverse Function 24
6.7. Selecting a File System 25
6.7.1. Continuous Rotary File Systems 25
6.7.2. Reciprocating File Systems 26
6.7.3. “Program” for Continuous Rotary File Systems 27
6.7.4. Changing Torque and Speed 27
6.8. Factory Default Parameters 28
6.9. Battery Refresh 29
6.10. Displaying the Software Version 29
6.11. Maintenance 30
6.11.1.Changing the Battery 30
6.11.2.Lubricating the Contra-angle 31
6.12. Cleaning, Disinfection and Sterilization 32
6.12.1.Foreword 32
6.12.2.General Recommendations 32
6.12.3.Step-by-Step Procedure 33

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7. Technical Specifications 34
7.1. Classifications of Equipment 34
7.2. Product Main Specifications 34
8. Error Code 36
9. Troubleshooting 39
10. Warranty 40
11. Disposal of the Product 41
12. Identification of Symbols 41
13. Program – Individual Continuous Rotary Program 42
APPENDIX
Electromagnetic Emissions and Immunity 204

FISDR-JAP / F1902124.X / 00 / 2011 – created 07/2011 - 7 / 208 -
FOR DENTAL USE ONLY
Introduction
Congratulations on your purchase of the X-SMART
™
Plus endo motor.
Read this User Manual carefully before use for operating instructions, care and maintenance.
Keep this manual for future reference.

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1. Indications for use
The X-SMART
™
Plus endo motor is a medical device according to the Medical Device
Directive 93/42/EEC, designed for use by dentists for driving dental root canal instruments in
continuous rotation and in reciprocating movement.
This device must only be used in hospital environments, clinics or dental offices by qualified
dental personnel.
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.) it is recommended not to use the X-SMART
™
Plus.
•X-SMART
™
Plus should not be used for severely curved root canal preparation.
•Do not use X-SMART
™
Plus for implant or any other dentist procedure outside
endodontics.
3. Warnings
In this chapter, a description of serious adverse reactions and potential safety hazards for the
product or the user/patient is included.
Read the following warnings before use.
WARNINGS
•The device must only be used in suitable locations and only by specialized physicians
licensed to practice dentistry.
•Use the specified battery for this device. Never use any other batteries than those that
Dentsply Maillefer specifies.
•Use the Dentsply Maillefer AC adapter for this device. Never use any other AC adapters.
•If you should notice battery fluid leak, deformation of the motor handpiece casing or partial
discoloring, immediately stop use and contact your distributor.
•Should the battery fluid come 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 come into contact with 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.
•If you do not use the device for a long period of time, remove the battery to avoid fluid leak.
•Do not expose the device to direct or indirect sources of heat. Operate and store the device
in a safe environment.
•When installing the device, leave approximately 10cm around the control unit for easy
access to the inlet and the power cord.
•Place the device on a flat and stable surface.

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•Do not disassemble or alter the device; Dentsply Maillefer declines any responsibility in
case of alteration or modification of the device.
•Do not expose the X-SMART
™
Plus unit, motor handpiece or AC adapter to any liquid.
•Do not drop the device.
•The X-SMART
™
Plus requires special precautions as regards electromagnetic compatibility
(EMC) and must be installed and commissioned in strict conformity with the EMC
information provided in this instruction manual. Specifically, do not use the device close to
fluorescent lamps, radio transmitters and remote controls.
•In order to avoid possible risks due to electromagnetic interference, do not use any
electrical medical device or electrical device of any other kind in close proximity to the X-
SMART
™
Plus. The electromagnetic radiation emitted by the device is below the
recommended limits set forth in pertinent regulations in force (EN 60601-1-2:2007).
•Do not use the device in the presence of free oxygen or anesthetic substances or
flammable products.
•The device may possibly malfunction if used in the presence of an electromagnetic
interference wave. Do not install the X-SMART
™
Plus in the vicinity of any device that emits
magnetic waves.
•The use of accessories, transducers and cables other than those specified may result in
increased emissions or decreased immunity performance of the device.
•None of the X-SMART
™
Plus components are delivered disinfected or sterilized:
components such as control unit, micromotor and micromotor cable need to be disinfected,
the contra-angle needs to be sterilized prior to first use and in between each patient!
•Never place the motor handpiece or any other device accessories in an autoclave unit or
ultrasonic tank.
•None of the components of the X-SMART
™
Plus may be sterilized (contra-angle excluded,
see chapter 6.12. Cleaning, Disinfection and Sterilization).
•Do not immerse the device in ultrasonic cleaners.
•The plastic enclosure is not sealed, do not use any liquid or spray directly on the unit,
especially on the monitor or near the electrical sockets.
•Do not crimp the cords exiting the motor handpiece and AC adapter.
•This device is equipped with an electronic circuit to limit file separation. Nevertheless, files
may still separate due to incorrectly set torque or speed, or the use of fatigued files.
•Follow the file manufacturer’s instructions for use of the endodontic files.
•The file system shown on the display must always match the file in use. This is of the
utmost importance in order to avoid misusing reciprocating files and continuous rotary files.
•Do not use files designed for continuous rotation in reciprocating motion.
•Do not use files designed for reciprocating motion in continuous rotation.
•Torque and speed values are subject to change by the file manufacturers without notice.
Therefore, the preset values in the library must be checked prior to use. Torque values
shown on the screen are accurate and reliable only with X-SMART
™
Plus 6:1 contra-angles
properly maintained and lubricated.
•The accuracy of movement provided by the motor is guaranteed only if the original X-
SMART
™
Plus 6:1 contra-angle is used, properly maintained and lubricated (for more
details see chapter 6.11.2. Lubricating the Contra-angle).

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•Do not use any other contra-angle or other reduction rate other than the original one.
•Do not insert any file in the contra-angle during calibration.
•Calibrate every time the contra-angle is lubricated or replaced after sterilizing, or at least
once a week (see chapter 6.5.6. Calibration).
•When lubricating the contra-angle, carefully check that no lubricant penetrates the motor
handpiece.
•Do not lubricate the motor handpiece for any reason, as lubricant contamination of the
motor handpiece might damage it and may have a strong negative effect on its safe
operation.
•Never introduce any foreign objects into the motor handpiece shaft.
•The motor handpiece may overheat if excessive force is applied. If the motor handpiece
overheats too often or overheating persists, contact your distributor.
•Before starting the motor handpiece, verify the correctness of the motor settings.
•The AC adapter must be supplied at a voltage ranging between: 100 – 240 V (+/- 10%), 47-
63 Hz. Use only original parts.
•Should any anomalies arise during operation, suspend work and contact your distributor.
4. Precautions
Read these safety precautions thoroughly prior to use. These precautions allow you to use the
product safely, preventing harm to you and others.
It is of the utmost importance that this manual is preserved for future consultation. The manual
must accompany the system in all cases of sale or other transfer in order that the new owner
may reference the precautions and warnings.
Gloves and a rubber dam are mandatory during the use of X-SMART
™
Plus.
Refer to the WARNINGS chapter (see chapter 3) to verify any special care to exercise before
starting to use the complete device.
•The appliance must only be used with the manufacturer’s original accessories.
•Before changing the contra-angle or file, turn off the power of the unit. Changing with the
power kept on may cause unintended rotation by accidental touch of the ON/OFF key.
•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.
•Pay attention to the direction of the battery connector when installing. Forcible setting in the
wrong direction may cause damage and fluid leakage due to a short circuit.
•Fully-charged rechargeable batteries generally discharge gradually over time even though
the device is not used. It is recommended to recharge the battery just before use.
•Should the device stop automatically due to low battery voltage, it may not indicate low
voltage immediately when the device is powered on again.

FISDR-JAP / F1902124.X / 00 / 2011 – created 07/2011 - 11 / 208 -
•Recharge rechargeable battery after it depletes as much as possible. Repeating short-time
use and subsequent recharging may shorten its operating time due to the “memory effect.”
The battery may recover after repeating complete discharge and full charge for a few times
(see chapter 6.9. Battery Refresh).
•The used Nickel Metal Hydride batteries are recyclable, but their disposal may sometimes
not be permitted by law in your location. Return them to your distributor.
•When disposing of the control unit, follow the instructions of your local government for
disposal, as they contain materials which may become industrial waste.
•When discarding the contra-angle and motor handpiece, dispose of them as medical
waste.
The manufacturer declines any responsibility in the case of:
•Use of the device for applications other than those specified in the instructions for use and
maintenance.
•Modifications or repairs performed by persons not authorized by the manufacturer.
•Use of non-original components or components other than those specified in the
STANDARD COMPONENTS chapter (see chapter 6.1).
•File breakage due to misuse.
•Accessories or device breakages due to sterilization: none of the X-SMART
™
Plus
components are sterilizable (except for the contra-angle).
5. Adverse Reactions
There are no known adverse reactions.
6. Step-by-Step Instructions
Refer to the WARNINGS chapter (see chapter 3) to verify any special care to exercise before
starting to use the complete device.
Before use, please check the exact contents of the package.
Ambient Conditions for Operation
-Use: indoor
-Ambient temperature: 10°C – 40°C (50°F – 104°F)
-Relative humidity: 30% – 75%
-Atmospheric pressure: 700hPa – 1060hPa
-The original packing materials may be stored and shipped in ambient conditions of
-10°C to + 50°C (from 14°F to 122°F) with relative humidity at 10% - 85% and
atmospheric pressure at 500hPa to 1060hPa.
WARNING
Do not install the device in damp places or in places where it will come into constant contact
with liquids of any kind.

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6.1. Standard Components
The X-SMART
™
Plus is supplied with the components listed below:
1. Control unit
2. Motor handpiece with cable and connector
3. X-SMART
™
Plus 6:1 contra-angle
4. Handpiece stand
5. F-type spray nozzle (used for lubrication)
6. AC adapter, model Cincon Electronics Co. Ltd, TR30RAM180 with EU, UK, USA, AUS
exchangeable plugs
Torque card
User Manual
5
1
2
4
3
6

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6.2. Operation Panel
Fig. 1 Operation Panel
1 POWER Switches the device on and off (keep pressed for more than 2
seconds).
2 SPEED + / - Adjust the rotation speed (possible only for continuous rotary
systems).
3 TORQUE + / - Adjust the torque limit (possible only for continuous rotary
systems).
4+5 SYSTEM  /  Change the file system.
6+7 FILE ⊳ /  Change the file within a system.
8 REV Changes the rotational direction of the file (only possible for
continuous rotary systems).The rotational direction can also be
changed while the file is in motion.
1
10
9
8
12
6
4
7
13
14
2
11
3
5

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9 AUTO REV Only for continuous rotary systems, selects one of the 3 auto
reverse modes (see chapter 6.6.4. Auto Reverse Function):
AUTO REVERSING: Automatic stop and reverse motion followed
by forward rotation when preset torque is reached.
AUTO STOP: Automatic stop and reverse motion followed by stop
when the preset torque is reached.
AUTO REVERSE OFF: Auto reverse mode is not activated.
10 CAL Calibrates the contra-angle to ensure torque accuracy each time
the contra-angle is replaced or lubricated (keep pressed for more
than 2 seconds).
11 MEMO Saves modifications to the speed, torque limit values and auto
reverse mode in each system where modifications are possible
(keep pressed for more than 2 seconds).
12 SOUND VOLUME Adjusts the sound volume.
13 AC-IN LAMP Lights green when the control unit is connected to the mains.
14 CHRG LAMP Lights or flashes orange while battery is charging or in the refresh
mode (see chapter 6.9. Battery Refresh) and in an error condition
(see chapter 8. Error Code).

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6.3. LCD Panel
Fig. 2 LCD Panel
1 SYSTEM Displays the selected file system (See chapter 6.6.1. File Library).
2 FILE Displays the selected file(s) (See chapter 6.6.1. File Library).
3 SPEED Displays the instrument rotation speed value (disabled for
reciprocating systems).
4 TORQUE Displays the torque limit value (disabled for reciprocating systems).
5 TORQUE BAR D i s p l a y s t h e b a r g r a p h w h i c h s h o w s t h e d e g r e e o f l oad applied to
the motor while the file is in continuous rotation (disabled for
reciprocating systems).
6 AUTO REVERSE Displays the selected auto reverse mode (disabled for
reciprocating systems).
3 modes can be selected (see chapter 6.6.4. Auto Reverse
Function):
AUTO REVERSING:
AUTO STOP:
AUTO REVERSE OFF: (No mark)
2
1
3
4
5
6
7
8
9

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7 ROTATIONAL DIRECTION
Displays the current rotational direction of the file.
3 marks can be displayed:
Forward (clockwise) continuous rotation
R e v e r s e ( c o u n t e r c l o c k w i s e ) c o n t i n u o u s r o t a t i o n
Reciprocating motion
8 BATTERY Displays the present remaining amount of the battery. The mark is
animated when the battery is charging (see chapter 6.5.5.
Charging the Battery).
Full charge
A p p ro x i ma t e ly 30 - 8 0% re m a i ns
Less than 30% remains. In this case, the auto
reverse function may not activate (See chapter
6.6.4. Auto reverse function).
Battery is drained or very low battery voltage.
Charge the battery (see chapter 6.5.5. Charging the
Battery).
NOTE
The remaining amount of battery mark indicates a voltage. When a load is applied to
the motor handpiece, the remaining amount of battery mark appears to become lower.
9 SOUND VOLUME Displays the current sound volume (see chapter 6.5.7. Sound
Volume Adjustment).
3 marks can be displayed:
H i g h v o l u m e
L o w v o l u m e
L i m i te d o f f

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6.4. Preparation
1. Carefully remove the device and the accessories from their packaging and place them on a
flat surface.
2. Check that all the components listed in the STANDARD COMPONENTS chapter (see
chapter 6.1) are present.
3. Remove the protective plastic film from the operation panel.
WARNING
Should any liquid exit the device, interrupt the installation immediately and send the machine
to your distributor.
6.5. Installation
6.5.1. Connecting the AC adapter
1. Select the plug adapter that matches your electric power outlet for the power supply.
Fig. 3 Plug adapters for power supply
Place the required plug adapter onto the two contacts on the power supply and push it toward
the locking button (B) until it snaps into place. You must press the locking button (B) to change
the adapter (see Fig. 3).

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Fig. 4 Power and Motor handpiece connectors
2. Charge the battery before the first use (see chapter 6.5.5. Charging the Battery):
a. Connect the AC adapter to the mains.
b. Securely insert the connector of the AC adapter in the jack connector (A – see Fig. 4) on
the left side of the device.
c. Completely charge the battery prior to first use.
CAUTION
To disconnect the cables, always hold at the central part of the connector and pull out. Do not
pull the cable.
6.5.2. Connecting and Disconnecting the Motor Handpiece
Connecting
Align the  mark of the cord plug with the ▲mark of the unit connector (B – see Fig. 4) at the
left side of the device and insert the plug until it locks.
Disconnecting
Hold the plug ring and pull it out. Do not twist in any direction.
B
A

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6.5.3. Connecting and Disconnecting the Contra-angle
Connecting
The contra-angle can be connected at 6 adjustable head positions. Align the positioning pins
of the contra-angle with the positioning slots of the motor handpiece and insert the head until it
clicks (see Fig. 5).
Disconnecting
When removing the contra-angle, pull it straight out (see Fig. 5).
Fig. 5
CAUTIONS
•When attaching and detaching the contra-angle, turn the power off beforehand.
•Check that the contra-angle is securely assembled to the motor handpiece.
6.5.4. Inserting and Removing the File
File insertion
Insert the file into the chuck until it stops.
Lightly turn the file until it engages with the latch mechanism. Push inwards to click.
File removal
Press the push-button and pull out the file (see Fig. 6).
Fig. 6
CAUTIONS
•When attaching and detaching the file, turn the power off beforehand.
•After the file is locked in place, lightly pull out the file to make sure the file is locked.
•Always clean the shank of the file to be installed. Allowing dirt to enter the chuck could
cause deterioration of chucking force.
Motor handpiece
Contra-angle

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6.5.5. Charging the Battery
The X-SMART
™
Plus is powered by a rechargeable Nickel Metal Hydride (NiMH) battery.
1. Securely insert the plug of the AC adapter into a power supply (see chapter 6.5.1.
Connecting the AC adapter).
2. The AC-IN lamp lights in green.
3. The internal microcomputer checks the voltage of the batteries and starts charging, if
necessary. If the charging starts, the CHRG lamp lights up.
4. When the CHRG lamp turns off, charging is completed.
NOTES
•There is no need to turn the power on to charge the battery.
•The AC-IN lamp lights to indicate that the supply power is on. It does not go out even after
a charge is completed. See the CHRG lamp to check the charging conditions.
•The standard charging time is about 5 hours, but it varies depending on use, condition of
the battery, temperature and whether the battery is new or old.
Older batteries may remarkably shorten both the charging and operating time.
•When charging, the temperature of the battery is measured.
Therefore, if this product is placed in an environment where the temperature changes
rapidly (for example, near to a window exposed to sunlight, near the outlet of an air
conditioner, or heater), the battery cannot be properly charged.
Store and charge this product in a place with low variations in temperature.
•The battery automatically charges when connected to the mains, even when the power is
on. But when the motor handpiece is in use, charging is suspended to protect the battery.
•In the following cases, it may not start charging:
The temperature of the battery is too low or too high (less than 0°C (32°F) or more
than 40°C (104°F)).
The voltage of the battery is sufficient (this does not necessarily mean fully
charged).
Battery is not connected.
The voltage of the battery is abnormal (see chapter 8. Error Code).

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6.5.6. Calibration
This function is to decrease fluctuation in the rotation speed of the motor handpiece and the
difference in torque by the contra-angle.
Calibration is recommended when using a new/other contra-angle or after an extended period
of operation, as the running properties can change with usage, cleaning and sterilization.
1. Turn the power off.
2. Attach the X-SMART
™
Plus 6:1 contra-angle to the motor handpiece.
3. Connect the AC adapter and check that the AC-IN lamp lights.
4. Turn the power on.
5. Hold down the CAL (10) key (see Fig. 1) for more than 2 seconds.
•During the calibration process the display will read:
•The motor handpiece begins to rotate: leave it as it is until it stops.
•When the calibration process is completed, the rotation stops and the display reads:
•Then, the display returns to its original state.
NOTES
•Should you at any time wish to stop the calibration process, turn the power off.
•Calibrate every time the contra-angle is lubricated or replaced after sterilizing, or at least
once a week (see chapters 6.11.2.Lubricating the Contra-angle and 6.12. Cleaning,
Disinfection and Sterilization).
•This function does not operate if the AC adapter is disconnected.
•Do not touch or apply a load to the contra-angle chuck during calibration.