Dentsply Sirona X-Smart Plus User manual

EN
User Manual

2/60 BENXSPSDFUWEB / Rev.09 / 10-2018
PAGE INTENTIONALLY LEFT BLANK

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Table of Contents
Table of Contents
1 Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5 Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6 Step-by-Step Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6.1 Standard Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
6.2 Operation Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
6.3 LCD Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
6.4 Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.5 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.5.1 Connecting the AC adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.5.2 Connecting and Disconnecting the Motor Handpiece . . . . . . . . . . . . . . . . . 21
6.5.3 Connecting and Disconnecting the Contra-angle . . . . . . . . . . . . . . . . . . . . . 21
6.5.4 Inserting and Removing the File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
6.5.5 Charging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
6.5.6 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
6.5.7 Sound Volume Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
6.6 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
6.6.1 File Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
6.6.2 Switch-on and Switch-off the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
6.6.3 Switch-on and Switch-off the Motor handpiece . . . . . . . . . . . . . . . . . . . . . . 28
6.6.4 Auto Reverse Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
6.7 Selecting a File System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
6.7.1 Continuous Rotary File Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
6.7.2 Reciprocating File Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
6.7.3 "Program" for Continuous Rotary File Systems . . . . . . . . . . . . . . . . . . . . . . 33
6.7.4 Changing Speed and Torque . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Table of Contents
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6.8 Factory Default Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
6.9 Battery Refresh . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
6.10 Displaying the Software Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
6.11 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
6.11.1 Changing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
6.11.2 Lubricating the Contra-angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
6.12 Cleaning, Disinfection and Sterilization . . . . . . . . . . . . . . . . . . . . . . . 40
6.12.1 Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
6.12.2 General recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
6.12.3 Step-by-Step Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
7 Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
7.1 Classifications of equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
7.2 Product Main Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
8 Error Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
9 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
10 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
11 Disposal of the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
12 Identification of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
13 Program - Individual Continuous Rotary Program . . . . . . . . . . . 54
Appendix: Electromagnetic Emission and Immunity . . . . . . . . . 55

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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
.

Indications for use
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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.
• The use of X-Smart ® Plus is not recommended in patients allergic
to metals.
•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.
3WARNINGS
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.

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Warnings
• Use the specified battery for this device. Never use any other
batteries than those that Dentsply Sirona specifies.
• Use the Dentsply Sirona 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.
• Do not disassemble or alter the device; Dentsply Sirona 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
.
•TheX-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.
• Portable and mobile radio frequency (RF) communications
equipment can affect the proper functioning of X-Smart ® Plus.

Warnings
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• 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).
• 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, with the exception of transducers and cables sold by the
manufacturer of the X-Smart ® Plus as replacement parts for
internal components, may result in increased emissions or
decreased immunity of the X-Smart ® Plus.
•X-Smart ® Plus 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 ® Plus should be observed to verify normal
operation in the configuration in which it will be used.
• 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.

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Warnings
• 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).
• 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.

Precautions
10/60 BENXSPSDFUWEB / Rev.09 / 10-2018
• 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.
• Clinical judgment needs to be applied by the end user of the device.
4PRECAUTIONS
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.

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Precautions
• 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.
• 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.
• This product does not consider a patient's age, gender, weight or
nationality.
• No special training is required for this device.
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.

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

Step-by-Step Instructions
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6.2 Operation Panel
Fig. 1 Operation Panel
110 9 8 12
13
14
4
7
6
5
3112
1POWER Switches the device on and off (keep
pressed for more than 2 seconds).
2SPEED + / - 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.

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Step-by-Step Instructions
8REV
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.
9 AUTO REV
Only for continuous rotary systems,
selects one of the 3 auto reverse
modes (see chapter 6.5.4 Inserting
and Removing the File):
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 (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).

Step-by-Step Instructions
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6.3 LCD Panel
Fig. 2 LCD Panel
1
2
5
3
4
76 8 9
1SYSTEM Displays the selected file system (See
chapter 6.6.1 File Library).
2FILE Displays the selected file(s) (See
chapter 6.6.1 File Library).
3 SPEED
Displays the instrument rotation speed
value (disabled for reciprocating
systems).
4TORQUE Displays the torque limit value
(disabled for reciprocating systems).
5TORQUE BAR
Displays the bar graph which shows the
degree of load applied to the motor
while the file is in continuous rotation
(disabled for reciprocating).

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Step-by-Step Instructions
6AUTO 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)
7ROTATIONAL
DIRECTION
Displays the current rotational direction
of the file. 3 marks can be displayed:
Forward (clockwise)
continuous rotation
Reverse (counterclockwise)
continuous rotation
Reciprocating motion

Step-by-Step Instructions
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8BATTERY
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
Approximately 30-80%
remains
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.
9SOUND VOLUME
Displays the current sound volume (see
chapter 6.5.7 Sound Volume
Adjustment)
3 marks can be displayed:
High volume
Low volume
Limited off

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Step-by-Step Instructions
6.4 Preparation
6.5 Installation
6.5.1 Connecting the AC adapter
Fig. 3 Plug adapters for power supply
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.
1. Select the plug adapter that matches your electric power outlet for the
power supply.
B

Step-by-Step Instructions
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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 ).
Fig. 4 Power and Motor handpiece connectors
A B
2. Charge the battery before the first use (see chapter 6.5.5 Charging the
Battery):
AConnect the AC adapter to the mains.
BSecurely insert the connector of the AC adapter in the jack connector
(A - see Fig. 4) on the left side of the device.
CCompletely 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.