DENTSPLY X-SMART User manual

User Manual
EN

2/48 JAP / F190270.EN / 07 / 2004 / updated 10/2015
PAGE INTENTIONALLY LEFT BLANK

Table of contents
JAP / F190270.EN / 07 / 2004 / updated 10/2015 3/48
Table of contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.1 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.2 Contra-indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.5 Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.6 Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.7 Classifications of Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2 Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3 Product Main Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.1 Operation Panel and LCD Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.2 Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.3 Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.4 Torque . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.5 Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.6 Reverse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.7 Gear Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.8 Auto Reverse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.9 Memo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.10 CHARGE Lamp (Orange) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.11 AC IN Lamp (Green) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.12 Bar Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5 How to connect each part . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.1 Connecting Motor Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.2 Connecting AC Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
5.3 Connecting Foot Pedal (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . 18

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4/48 JAP / F190270.EN / 07 / 2004 / updated 10/2015
6 Main Directions For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.1 Charge (if batteries are used) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.2 Changing the Contra Angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.3 Mounting and Removing File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.4 Preparatory Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
6.5 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
6.5.1 Auto Reverse Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
6.6 Completion of Medical Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
7 Additional Directions For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
7.1 Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
7.2 Initialization of Program (Factory-set configuration) . . . . . . . . . . . . . 27
7.3 Battery Refresh . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
7.4 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
7.5 Alarm Sound Volume Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
8 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
8.1 Lubricating Contra Angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
8.2 Cleaning Motor Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
8.3 Cleaning Control Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
8.4 Cleaning AC Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
9 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
9.1 Autoclaving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
10 Changing batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
10.1 Changing Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

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JAP / F190270.EN / 07 / 2004 / updated 10/2015 5/48
11 Error Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
12 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
13 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
14 Disposing Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
15 Identification of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Introduction
6/48 JAP / F190270.EN / 07 / 2004 / updated 10/2015
FOR DENTAL USE ONLY
1Introduction
Thank you for purchasing the X-SMART®.
1.1 Indications
X-SMART®is an endodontic micromotor to drive NiTi instruments. This
motor has to be used only in hospital environments, clinics or dental
offices by qualified dental personnel. Read this User Manual carefully
before use for operation instructions, care and maintenance. Keep this
User Manual for future reference.
1.2 Contra-indications
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 to not use the X-SMART®.
This motor should not be used for severe curved root canal preparation.
Do not use X-SMART®for implant or any other dentist procedure
outside endodontics.
1.3 Warnings
• Use the specified batteries for this product. Never use any other
batteries than those that Dentsply Maillefer specifies.
• Do not disassemble or alter the motor handpiece.
• Do not expose X-SMART®unit, motor handpiece or battery charger
to any liquid.
• If you should notice battery fluid leak, deformation of the motor
handpiece casing or partial discoloring, immediately stop use and
contact your dealer.

Introduction
JAP / F190270.EN / 07 / 2004 / updated 10/2015 7/48
• Should the leaking 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.
• If you will not use the product for a long period of time, remove the
batteries to avoid fluid leak.
• The system may present the possibility of malfunction when used in
the presence of electromagnetic interference wave. Do not install
the system in the vicinity of the device which emits magnetic waves.
• Do not use in the presence of flammable products.
• 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.
• When installing the device, leave approximately 10cm around the
control unit for easy access to the inlet and the power cord.
• Portable and mobile radio frequency (RF) communications
equipment can affect the proper functioning of X-SMART®.
•TheX-SMART®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.
•TheX-SMART®should not be used adjacent to or stacked with
other equipment. In the instance that if adjacent or stacked use is
necessary, the X-SMART®should be observed to verify normal
operation in the configuration in which it will be used.
• The use of accessories, transducers and cables other than those
specified, with the exception of transducers and cables sold by the
manufacturer of the X-SMART®as replacement parts for internal
components, may result in increased emissions or decreased
immunity of the X-SMART®.
• Clinical judgment needs to be applied by the end user of the device.

Introduction
8/48 JAP / F190270.EN / 07 / 2004 / updated 10/2015
1.4 Precautions
• The appliance must only be used with the manufacturer's original
accessories.
• Use the Dentsply Maillefer AC adapter for this product. Never use
any other AC adapters.
• The RPM number indicates true instrument speed when the
appropriate reduction rate is selected. Make sure the selected
reduction matches the ratio of the contra angle handpiece.
• If the motor stops or runs too fast, discontinue use and call for
assistance.
• After sterilization, make sure the motor has reached a temperature
below 40°C before use.
• 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 700 - 1060hPa, and no moisture
condensation in the Control Unit. Any use outside these limits may
cause malfunction.
• Do not use a bent, damaged, deformed or non-ISO-conforming file.
Using such a file may result in personal injury due to its unexpected
breaking or “flying off” during rotation.
• 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 slightly at that time,
immediately stop use and contact your dealer.
• 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 head or bur, turn off the power of the motor
handpiece. Changing with the power kept on may cause
unintended rotation by accidental touch of the ON/OFF button.
• Pay attention to the direction of batteries when setting. Forcible
setting in the wrong direction may cause damage and fluid leakage
due to a short circuit.
• EQUIPMENT not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrousoxide.
• This product does not consider a patient’s age, gender, weight or
nationality.
• No special training is required for this device.

Introduction
JAP / F190270.EN / 07 / 2004 / updated 10/2015 9/48
1.5 Notice
• Fully-charged rechargeable batteries generally discharge gradually
over time even though the motor handpiece is not used. It is
recommended to recharge the batteries just before use.
• 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 due to
battery characteristics. Since the voltage drop does not coincide
with the remaining battery capacity, consider it only as a yardstick.
• Recharge rechargeable batteries after they deplete as much as
possible. Repeating shorttime use and subsequent recharging may
shorten their operating time due to the “memory effect.” Batteries
may recover after repeating complete discharge and full charge for
a few times. (This product is equipped with a “Refresh Mode” for
this purpose.).
• The used nickel metal hydride batteries are recyclable, but their
disposal may sometimes not be permitted by the country. Return
them to your dealer.
• When disposing of the control unit and foot pedal (optional), follow
the instructions of your local government for disposal, as they
contain materials which may become industrial waste.
• When discarding the contra angle head and motor handpiece,
dispose of them as medical waste.
• Users are responsible for operational control, maintenance and
inspection.
• Store the system in the place where the temperature is at -10 -
50°C (14 - 122°F), humidity at 10 - 85% RH, atmospheric pressure
at 500 - 1060 hPa, and the system is not subject to air with dust,
sulfur or salinity.
1.6 Adverse Reactions
None known.

Introduction
10/48 JAP / F190270.EN / 07 / 2004 / updated 10/2015
1.7 Classifications of Equipment
• Type of protection against electric shock :
- Class II equipment: and internally powered equipment.
• Degree of protection against electric shock :
- Type B applied part: .
• Method of sterilization or disinfection recommended by the
manufacture:
- See Sterilization procedure.
• Degree of protection against ingress of water as detailed in the
current edition of IEC 60529:
- Foot Pedal (Option) : IPX1 (Protected against vertically falling
water drops).
• Degree of safety of application in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrousoxide:
- X-SMART®complies to IEC60601-1 safety standard and the
requirement of CE Marking of Conformity.
• Mode of operation:
- Continuous operation.