Dentsply Maillefer X-SMART User manual

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Introduction
- Indications
- Contra-indications
- Warnings
- Precautions
- Notice
- Adverse reactions
A> Contents
B> Product Main Specifications
C> Product Description
D> How to connect each part
E> Main Directions For Use
F> Additional Directions For Use
G> Cleaning
H> Sterilization
I> Changing Batteries
J> Error Code
K> Trouble Shooting
L> Warranty
M> Disposing Product
N> Other Symbols
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Thank you for purchasing the X-
SMART
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
Operation Manual carefully before use for operation instructions, care and maintenance. Keep
this Operation Manual for future reference.
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 elec-
tric 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.
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.
●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 thor-
oughly 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 elec-
tromagnetic 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.
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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 500-1060hPa, 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 but-
ton.
●Pay attention to the direction of batteries when setting. Forcible setting in the wrong direc-
tion 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.
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 short-
time 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.).
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●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.
Adverse reactions: none known
Classifications of equipment
●Type of protection against electric shock :
- Class II 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.
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A> Contents
Before use, please refer to the packaging labels
B> Product Main Specifications
X-SMART control unit
Rated input DC20V 0.5A
Output DC7V 0.4A
Charging time 5 hours approx.
Dimensions W98 x D152 x H139mm
Weight 456g
Rated input AC120V 50/60Hz 10VA
AC230V 50/60Hz 10VA
Dimensions W70 x D110 x H58mm
Weight 120V: 934g
230V: 974g
X-SMART AC adapter
Rated input DC7V 0.4A
Dimensions Ø20 x L108mm
Weight 92g (including motor handpiece cord)
X-SMART motor handpiece
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C> Product Description
1) Control Unit
2) Operation Panel
●See Fig. 2 “Operation Panel
and LCD Panel.”
3) LCD Panel
●See Fig. 2 “Operation Panel
and LCD Panel.”
●Error codes are displayed.
4) Power Cord Connector
5) Foot Pedal Connector
6) Motor Handpiece Connector
7) AC Adapter
8) Motor Handpiece
9) Contra Angle
10) Handpiece Stand
11) F-type Spray Nozzle
●(used for lubrication)
12) Foot pedal (Option)
option
Fig. 1
11
12
10
9
8
1
7
4
5
6
2
3
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* Operation Panel and LCD Panel.
Fig. 2
•POWER
●Holding down the POWER key for more than one second turns on the power and the LCD
panel lights.
●Holding down the POWER key for more than one second while the power is on turns off the
power and the LCD display turns off.
•SPEED
●The rotation speed can be adjusted.
●If the speed is to exceed the upper limit or fall below the lower limit, the alarm sounds.
•TORQUE
●The torque limit values can be adjusted.
●
If the torque is to exceed the upper limit or fall below the lower limit, the alarm sounds.
LCD
(LCD Panel)
Operation Panel
AC IN
REVERSE
SPEED
TORQUE
PROGRAM
MEMORIZE
CHARGE
AUTO REVERSE
POWER
GEAR RATIO
9
The present rotation speed is displayed.
The unit is rpm (min-1).
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The present torque limit value is displayed. The unit is (Ncm).When it reaches the max-
imum value, “”is displayed
•
PROGRAM
●The Program button is also used to manage the alarm sound.
•REVERSE
●The rotational direction of the file can be changed by this key. It can also be changed while
the file is in motion.
●The alarm sounds during reverse rotation.
The mark of the current rotational direction is displayed.
Forward Rotation (F).
Reverse Rotation (R).
•GEAR RATIO
●A gear ratio can be selected by this key. If the correct gear ratio is selected according to the
contra angle head in use, an adequate rotation speed and torque limit value can be set.
●The gear ratio cannot be changed while the file is in motion.
LCD
LCD
LCD
LCD
The present program number is displayed. The program number is available from 1 to 9.
The present gear ratio is displayed. The gear ratio is available at (1:1, 4:1, 10:1,
16:1 and 20:1).
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•AUTO REVERSE
The auto reverse mode can be selected by this key. (See “Auto Reverse Function.”)
The present auto reverse mode mark is displayed.
If the load is removed after auto reverse rotation, it
returns to the normal rotation again.
If the load is removed after autoreverse rotations, it
stops.
Auto reverse rotation is not activated.
•MEMO
Press this key if you want to change the present program setting (rotation speed, torque limit
value, gear ratio, auto reverse mode) and these changes will be memorized. (See “Program”)
•CHARGE Lamp (Orange)
This lamp lights or flashes while the batteries are being charged or in the refresh mode, (See
“Battery Refresh”) and in an error condition, regardless of the ON or OFF position of the power.
The mark of the present remaining amount of the batteries is displayed regardless of the ON or
OFF position of the power. The mark will be animated when the batteries are being charged or
in the refresh mode (See “Battery Refresh”).
LCD
LCD
AUTO REVERSING
AUTO STOP
AUTO REVERSE OFF
(Non display)
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NOTICE
The remaining amount of batteries mark indicates a voltage. When load is
applied to the motor handpiece, the remaining amount of batteries mark
appears to become lower.
•AC IN Lamp (Green)
This lamp lights when the power is supplied from the AC adapter, regardless of the ON or OFF
position of the power.
•Bar Display
Full charge
Approximately 30-80% remains
Less than 30% remains. In case of this condition, the auto reverse function may
not activate. (See “*Auto Reverse Function”)
Batteries are drained or in a remarkably low voltage. Charge the batteries
!
LCD
It displays the bar graph which shows the degree of load applied to
the motor while the file is in motion.
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D> How to connect each part
(1) Connecting Motor Handpiece
Align the mark of the cord plug of the motor
handpiece with the ▲mark of the motor hand-
piece connector and insert the plug until it locks.
(Fig. 3)
NOTICE
To remove the plug, hold the plug ring and pull it out.
(2) Connecting AC Adapter
Securely insert the jack of the AC adapter into the
power connector with the mark of the jack cast
down. (Fig. 4)
(3) Connecting Foot Pedal (Optional)
Securely insert the plug of the foot pedal (Optional)
into the foot pedal connector with the ▲mark of
the plug cast down. (Fig. 5).
•You do not have to connect the foot pedal, if you
intend to use this product without the foot
pedal.
!Fig. 3
Fig. 4
Fig. 5
Foot Pedal
connection (optional)
Adapter connection
Motor Handpiece
connection
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(1) Charge (if batteries are used)
1. Securely insert the plug of the AC adapter into a power supply.
2. The AC IN lamp lights in green.
3. The internal microcomputer checks the voltage of the batteries and starts charging, if neces-
sary. If it starts charging, the CHARGE lamp lights, and the remaining amount of the batter-
ies mark on the LCD panel will be animated.
•There is no need to turn on the power.
4. When the CHARGE lamp turns off, charging has been completed.
CAUTION
●Connect to AC120V or AC230V power supply only. Otherwise, malfunction will
occur.
●Since 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 CHARGE lamp to check the
charging conditions.
●The standard charging time is about 5 hours, but it varies depending on use,
condition of batteries, temperature and whether the batteries are new or old.
Please note, older batteries may remarkably shorten both the charging and
operating time.
!
E> Main Directions For Use
REVERSE
SPEED
TORQUE
PROGRAM
GEAR RATIO
MEMORIZE
POWER
AUTO REVERSE
CHARGE
AC IN
Fig. 6
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●When charging a battery, 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 a air conditioner, or heater), the battery cannot be properly charged.
Put this product in a place where the temperature varies little.
●In the following cases, it may not start charging:
❍The temperature of a battery is too low or too high. (less than
0˚C (32˚F) or more than 40˚C (104˚F)).
❍The voltage of a battery is sufficient. (This does not necessarily
mean fully charged).
❍A battery is not connected.
❍The voltage of a battery is abnormal. (See “ERROR CODE”).
●Batteries are automatically charged depending on conditions, even when the
power is on. But when the motor handpiece is used, charging is suspended to
protect the battery.
(2) Changing the Contra Angle
●The contra angle can be connected with
the motor handpiece at 6 adjustable head
positions. Align the positioning pins of the
contra angle head with the positioning
slots of the motor handpiece and insert
the head until they click.
●When removing the contra angle head,
pull it out axially. (Fig. 7)
CAUTION
●When attaching and detaching the contra angle head, turn the power off
beforehand.
●Check that the contra angle head is securely assembled to the motor handpiece.
!
Fig. 7
Motor Handpiece
15
Contra Angle
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(3) Mounting and Removing File
1. Insert the file into the chuck until it stops.
2. Lightly turn the file until it engages with the latch
mechanism. Push inwards to click.
●File Removal:
Depress the push-button and pull out
the file.
CAUTION
●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 loss of concentricity and deterioration of chucking force.
(4) Preparatory Operations
1. Charge the batteries (See “Charge (if batteries are used)”) or securely insert the plug of the
AC adapter into a power supply.
2. Hold down the POWER key for more than one second to turn on the power.
3. Press the PROGRAM key to select the program number suitable for the file being used.
4. Select the rotational direction by pressing the REVERSE key. The key changes over to the for-
ward rotation (F) and reverse rotation (R) each time it is pressed.
5. Select the auto reverse mode by pressing the AUTO REVERSE key. The key changes over to
AUTO REVERSING , AUTO STOP and AUTO REVERSE OFF each time it is pressed. (See “*Auto
Reverse Function”)
NOTICE
The PROGRAM key is fast-forwarded, when it is continuously held down.
!
!
Fig. 8
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(5) Operation
1.
●If you press the ON/OFF button briefly, the
motor handpiece starts. If you re-press the
button, it stops.
●If you hold down the ON/OFF button for
more than one second, the motor hand-
piece starts while the button is pressed. If you
release the button, it stops.
●If the foot pedal (Optional) is connected, stepping on the pedal starts the motor hand-
piece. Releasing the pedal stops it.
2. If you want to make fine adjustments on the rotation speed and torque limit value, press the
SPEED key and TORQUE key respectively.
NOTICE
●If the SPEED key and TORQUE key are continuously held down, they are fast-
forwarded.
●
If both ON/OFF button and foot pedal (Optional) are equipped, the one which rota-
tion instruction is first given has priority. For example, if you step on the foot pedal
(Optional) to start the motor handpiece, you cannot stop it by the ON/OFF button.
* Auto Reverse Function
When the motor handpiece starts and its load reaches approximately half of the preset torque
limit value, the alarm sounds. (at the time of on the bar display).
The alarm sound changes when the load approaches the torque limit value. (at the time of
on the bar display).
When a further load exceeds the torque limit value, the following 3 modes can be selected:
ON/OFF Button
Fig. 9
!
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AUTO REVERSING
The motor handpiece rotates in reverse. When a load is removed, the motor handpiece returns
to normal rotation (forward rotation) automatically.
AUTO STOP
The motor handpiece starts in reverse. When a load is removed, the motor handpiece stops. If
you want it to rotate (forward-rotate) again, re-press the ON/OFF button or re-step on the foot
pedal (Optional).
AUTO REVERSE OFF
The motor handpiece stops without reverse rotation. In this instance, the LCD panel shows
" " and the rotation speed alternately.
Fig. 10
Fig. 11
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NOTICE
●When the reverse rotation (R) is set, this auto reverse function is not activat-
ed.
●When the batteries go down (when the remaining amount of the batteries
mark indicates “”), the actual load may not reach the preset torque
limit value. In this case (in the case of operation by batteries), this auto reverse
function will not be activated. When high torque is required, use the AC
adapter or use this product in a condition where the batteries are not signifi-
cantly consumed (when the mark of the remaining amount of the batteries
indicates “”).
●If a load is continuously applied to the motor handpiece, it may automatically
stop to prevent overheating. (The torque limit value indicates “”on the
LCD panel). In this case, leave the motor handpiece for a while until it cools
down.
When the display returns to normal, the motor handpiece can be used.
(6) Completion of Medical Treatment
When the treatment is completed, return the motor handpiece to the handpiece stand and hold
down the POWER key for more than one second to turn off the power.
NOTICE
If 10 minutes pass without operation of the ON/OFF button and foot pedal
(optional), the power turns off automatically (auto power off function). However,
the power does not turn off automatically if the motor handpiece is in motion,
even if it is not used.
!
!
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F> Additional Directions For Use
(1) Program
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 (rotation
speed, torque limit value, gear ratio and auto reverse mode).
1. Press the PROGRAM key until it turns to the program number which you want to memorize.
2. Adjust the rotation speed, torque limit value, gear ratio and auto reverse mode by each key
according to your needs.
3. Hold down the MEMORIZE key for more than one second. When the alarm sounds, memo-
rization is completed.
NOTICE
●The program cannot be memorized while the motor handpiece is in motion.
●The rotational direction is not memorized in the program. The program cannot
be memorized if the rotational direction is set to the reverse rotation (R).
●If the PROGRAM key is held down, it is fast-forwarded.
●The program is not memorized unless the MEMORIZE key is held down for more
than one second. If the program number is changed by the PROGRAM key with-
out pressing the MEMORIZE key, the initially memorized preset values remain
(cancel function).
(2) Initialization of Program (Factory-set configuration)
The program can be returned to the original state configured at the time of factory ship-
ment, if setup becomes confusing.
1. Turn off the power, when the power is on.
2. Connect the AC adapter and confirm that the AC IN lamp lights up.
3. Hold down the POWER key for more than one second, while pressing the AUTO REVERSE
key and MEMORIZE key at the same time.
4. Release the keys when the LCD panel indicates “”and re-press the MEMORIZE key
while this is displayed.
5. Initialization is completed, when “”is displayed.
!
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NOTICE
●This function is not activated unless this product is powered by the AC adapter.
●If this function is used, all programs will disappear and return to the original
set values. Record the present program details accordingly, as needed.
(3) Battery Refresh
Nickel-metal-hydrate batteries may result in a decrease in charging capacity, if additional charg-
ing (repeating a cycle of short-time use and recharging) is made. (Generally, this phenomenon
is called a “memory effect”). This Battery Refresh function is to resolve this phenomenon.
1. Turn off the power if the power is on.
2. Connect the AC adapter and confirm that the AC IN lamp lights.
3. Hold down the POWER key for more than one second, while pressing the REVERSE key.
4. The alarm sounds for a length of time, and the refresh mode is activated. At this time, the
remaining amount of the batteries mark on the LCD panel is animated in the direction oppo-
site to display at the time of charging. At the same time, the CHARGE lamp flashes slowly.
5. Leave alone. The batteries are discharged and recharged automatically.
6. Hold down the POWER key for a while, when you want to stop this process. (At this time, the
power does not turn on.)
NOTICE
●This function is not activated, if not driven by the AC adapter.
●It takes a maximum of 5 hours to discharge batteries.
●It takes 5 hours to discharge and 5 hours to recharge, therefore, approximate-
ly 10 hours are required. For example, if a dental treatment is finished at 7 p.m.
and the refresh mode is set, the batteries will be fully charged by 5 a.m. the
next morning.
●This function is not required for each charging. This function should be used if
the operating time is shortened (even if the batteries are relatively new).
●Do not repeat activation and deactivation of the refresh mode in a short time.
It may result in enhancement of the memory effect.
●This function is fully effective for solution of a “memory effect.”However, it
cannot be solved completely at one time due to the characteristics of batter-
ies. We recommend you to repeat this process a few times according to your
needs.
!
!
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