xsmart plus User Manual Oct 2015

USER MANUAL Table of Contents 1. 2. 3. 4. 5. 6.

Introduction Indications for Use Contraindications Warnings Precautions Adverse Reactions Step-by-Step Instructions 6.1. Standard Components 6.2. Operation Panel 6.3. LCD Panel 6.4. Preparation 6.5. Installation 6.5.1. Connecting the AC adapter 6.5.2. Connecting and Disconnecting the Motor Handpiece 6.5.3. Connecting and Disconnecting the Contra-angle 6.5.4. Inserting and Removing the File 6.5.5. Charging the Battery 6.5.6. Calibration 6.5.7. Sound Volume Adjustment 6.6. Operation 6.6.1. File Library 6.6.2. Switch-on and Switch off the Unit 6.6.3. Switch-on and Switch off the Motor Handpiece 6.6.4. Auto Reverse Function 6.7. Selecting a File System 6.7.1. Continuous Rotary File Systems 6.7.2. Reciprocating File Systems 6.7.3. “Program” for Continuous Rotary File Systems 6.7.4. Changing Torque and Speed 6.8. Factory Default Parameters 6.9. Battery Refresh 6.10.Displaying the Software Version 6.11.Maintenance 6.11.1. Changing the Battery 6.11.2. Lubricating the Contra-angle 6.12.Cleaning, Disinfection and Sterilization 6.12.1. Foreword 6.12.2. General Recommendations 6.12.3. Step-by-Step Procedure

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

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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.

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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.  Portable and mobile radio frequency (RF) communications equipment can affect the proper functioning of X-SMART Plus.  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 XSMART 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, 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.  The 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 contraangle 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. FISDR-JAP / F1902124.X / 06 / 2011 – updated 10/2015

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 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 XSMART 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.  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%), 4763 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.

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.

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 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.  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.

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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

2 3

4 6

5

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 FISDR-JAP / F1902124.X / 06 / 2011 – updated 10/2015

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6.2.

Operation Panel Fig. 1 Operation Panel

1

10

9

8

12

13 14 4 7

6 5

2

11

3

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.

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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

6

7

8

9

1 2 3 4

5

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

Displays the bar graph which shows the degree of load 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:

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(No mark)

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7

ROTATIONAL DIRECTION Displays the current rotational direction of the file. 3 marks can be displayed: Forward (clockwise) continuous rotation Reverse (counterclockwise) continuous rotation 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 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. 9

SOUND 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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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

A

B

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.

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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

Contra-angle

Motor handpiece

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. FISDR-JAP / F1902124.X / 06 / 2011 – updated 10/2015

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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). During approximately 3 seconds after the connection or disconnection of the AC adapter, the control unit cannot be switched on.

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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.

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6.5.7. Sound Volume Adjustment The sound volume can be adjusted to 3 different levels: high, low and limited off (the sound appears with a low level at the time of confirmation and error, but it does not sound during reverse rotation, nor when reaching the torque limit value. 1. Press the sound volume (12) key (see Fig. 1). 2. The sound volume and the volume mark on the LCD panel change. NOTES  The last sound volume is retained, even if the power is turned off.  If “reset to default parameters” is carried out, the sound is set to the high level.

6.6.

Operation

6.6.1. File Library The device contains a file library with the following preset NiTi systems: A. Continuous rotary systems  Gates  Proglider™  PathFile®  Protaper Next™  Protaper® Universal  Program (individual programs) B. Reciprocating systems  WaveOne® Gold  WaveOne®  RECIPROC® The manufacturer reserves the right to update the file library and the systems contained in it. WARNINGS  Follow the file manufacturer’s instructions for use of 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.  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 display are accurate and reliable only with X-SMART Plus 6:1 contra-angle properly maintained and lubricated.

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