x-smart User Manual

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 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. Warnings ●

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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 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.

Precautions ● ● ●

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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 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.

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.

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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.

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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.). 5

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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.

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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.

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Adverse reactions: none known Classifications of equipment ●

Type of protection against electric shock : - Class II equipment:

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Degree of protection against electric shock : - Type B applied part:

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Method of sterilization or disinfection recommended by the manufacture: - See Sterilization procedure

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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)

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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

X-SMART AC adapter Rated input

AC120V

50/60Hz

10VA

AC230V

50/60Hz

10VA

Dimensions

W70 x D110 x H58mm

Weight

120V: 934g 230V: 974g

X-SMART motor handpiece Rated input

DC7V

0.4A

Dimensions

Ø 20 x L108mm

Weight

92g (including motor handpiece cord)

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C> Product Description 7 1 3 4 5 2

6 option 8 11

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12 10

Fig. 1

1) Control Unit 2) Operation Panel ●

See Fig. 2 “Operation Panel and LCD Panel.”

3) LCD Panel ●

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See Fig. 2 “Operation Panel and LCD Panel.” Error codes are displayed.

4) Power Cord Connector

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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)

* Operation Panel and LCD Panel. Operation Panel

(LCD Panel)

AC IN

CHARGE REVERSE SPEED AUTO REVERSE POWER

TORQUE PROGRAM

GEAR RATIO MEMORIZE

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. ●

LCD The present rotation speed is displayed. The unit is rpm (min-1).

• 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. 9

LCD

The present torque limit value is displayed. The unit is (Ncm). When it reaches the maximum value, “ ” is displayed

• PROGRAM LCD The present program number is displayed. The program number is available from 1 to 9.

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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. ●

LCD 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 The present gear ratio is displayed. The gear ratio is available at (1:1, 4:1, 10:1, 16:1 and 20:1). 10

• AUTO REVERSE The auto reverse mode can be selected by this key. (See “Auto Reverse Function.”) LCD The present auto reverse mode mark is displayed.

AUTO REVERSING

If the load is removed after auto reverse rotation, it returns to the normal rotation again.

AUTO STOP

If the load is removed after autoreverse rotations, it stops.

AUTO REVERSE OFF

Auto reverse rotation is not activated.

(Non display)

• 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.

LCD 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”).

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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

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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 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 handpiece connector and insert the plug until it locks. (Fig. 3) Motor Handpiece connection

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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)

Adapter connection

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).

Foot Pedal connection (optional)

• You do not have to connect the foot pedal, if you intend to use this product without the foot pedal.

Fig. 5

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E> Main Directions For Use

REVERSE AC IN

SPEED

CHARGE

TORQUE PROGRAM

AUTO REVERSE POWER

MEMORIZE

GEAR RATIO Fig. 6

(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 necessary. If it starts charging, the CHARGE lamp lights, and the remaining amount of the batteries 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.

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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. 14

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) Contra Angle

Motor Handpiece

Fig. 7

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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.

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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. Fig. 8

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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.

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(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 forward 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” )

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NOTICE The PROGRAM key is fast-forwarded, when it is continuously held down.

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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.

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If you hold down the ON/OFF button for more than one second, the motor handpiece starts while the button is pressed. If you release the button, it stops.

ON/OFF Button

Fig. 9

If the foot pedal (Optional) is connected, stepping on the pedal starts the motor handpiece. 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. ●

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NOTICE

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If the SPEED key and TORQUE key are continuously held down, they are fastforwarded.

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If both ON/OFF button and foot pedal (Optional) are equipped, the one which rotation 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:

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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.

Fig. 10

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).

Fig. 11

AUTO REVERSE OFF The motor handpiece stops without reverse rotation. In this instance, the LCD panel shows " " and the rotation speed alternately.

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NOTICE When the reverse rotation (R) is set, this auto reverse function is not activated. ● 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 significantly 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.

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(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.

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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, memorization is completed.

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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 without 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 shipment, 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.

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(3) Battery Refresh Nickel-metal-hydrate batteries may result in a decrease in charging capacity, if additional charging (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 opposite 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.)

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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, approximately 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 batteries. We recommend you to repeat this process a few times according to your needs. ●

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(4) Calibration This function is to decrease fluctuation in the rotation speed of the motor handpiece and the difference in torque by the contra angle. 1. Lubricate the contra angle with an appropriate spray (see “Lubricating Contra Angle Head”). 2. Turn the power off if the power is on. 3. Connect the AC adapter and confirm that the AC IN lamp lights. 4. Turn on the power. 5. Hold down both buttons of the SPEED key simultaneously for more than one second. 6. The LCD panel displays “ ” with the alarm sound. 7. Attach the contra angle head to the motor handpiece and press the MEMO key. 8. The motor handpiece begins to rotate : leave it as it is until it stops. 9. This process ends, if the rotation stops and the LCD panel display returns to its original state. 10. If you want to stop this process, turn the power off.

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NOTICE Lubricate the contra angle before Calibration. ● This function does not operate if AC adapter is not used. ● Do not touch or apply a load to the rotating shaft of the contra angle head : it obstructs. ● This function cannot completely absorb the individual difference of the actual motor handpiece and contra angle. ●

(5) Alarm Sound Volume Control The alarm sound volume can be controlled by using “BIG VOLUME, SMALL VOLUME and LIMITED OFF”. With “LIMITED OFF”, the alarm sounds with a small sound volume at the time of confirmation and error, while it does not sound at the time of reverse rotation and attainment of the torque limit value. 1. Keep holding down both buttons of the PROGRAM key simultaneously. 2. The alarm mark on the LCD panel changes, and the sound volume changes. 3. Release the PROGRAM key when the sound volume reaches your required level and the required sound level is set up.

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NOTICE The sound level is retained, even if the power is turned off. ● If “Initialization of Program (Factory-set configuration)” is executed, the sound is set to “BIG VOLUME.”

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