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DENTSPLY X-Smart Plus User Manual

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USER MANUAL

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  Summary of Contents for DENTSPLY X-Smart Plus

  • Page 1 USER MANUAL...
  • Page 2 Electronic instructions for use For additional languages, visit our website: www.dentsplymaillefer.com Technical modifications on our products are not subject to notification. Photos on our devices are not contractual. - 2 / 47 - FISDR-JAP / F1902124.EN / 07 / 2011 – updated 10/2016...
  • Page 3: Table Of Contents

    USER MANUAL Table of Contents Introduction 1. Indications for Use 2. Contraindications 3. Warnings 4. Precautions 5. Adverse Reactions 6. 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.
  • Page 4 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 - 4 / 47 - FISDR-JAP / F1902124.EN / 07 / 2011 –...
  • Page 5: Introduction

    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. - 5 / 47 - FISDR-JAP / F1902124.EN / 07 / 2011 –...
  • Page 6: Indications For Use

    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. Warnings In this chapter, a description of serious adverse reactions and potential safety hazards for the product or the user/patient is included.
  • Page 7 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.
  • Page 8: Precautions

     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.
  • Page 9: Adverse Reactions

     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). Adverse Reactions There are no known adverse reactions.
  • Page 10: Step-By-Step Instructions

    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 –...
  • Page 11: Standard Components

    6.1. Standard Components The X-SMART Plus is supplied with the components listed below: 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...
  • Page 12: Operation Panel

    6.2. Operation Panel Fig. 1 Operation Panel POWER Switches the device on and off (keep pressed for more than 2 seconds). SPEED + / - Adjust the rotation speed (possible only for continuous rotary systems). TORQUE + / - Adjust the torque limit (possible only for continuous rotary systems).
  • Page 13 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.
  • Page 14: Lcd Panel

    6.3. LCD Panel Fig. 2 LCD Panel SYSTEM Displays the selected file system (See chapter 6.6.1. File Library). FILE Displays the selected file(s) (See chapter 6.6.1. File Library). SPEED Displays the instrument rotation speed value (disabled for reciprocating systems). TORQUE Displays the torque limit value (disabled for reciprocating systems).
  • Page 15 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 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).
  • Page 16: Preparation

    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.
  • Page 17: Connecting And Disconnecting The Motor Handpiece

    Fig. 4 Power and Motor handpiece connectors 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.
  • Page 18: Connecting And Disconnecting The Contra-Angle

    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 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.
  • Page 19: Charging The Battery

    6.5.5. Charging the Battery The X-SMART Plus is powered by a rechargeable Nickel Metal Hydride (NiMH) battery. Securely insert the plug of the AC adapter into a power supply (see chapter 6.5.1. Connecting the AC adapter). The AC-IN lamp lights in green.
  • Page 20: Calibration

    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.
  • Page 21: Sound Volume Adjustment

     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.
  • Page 22: Switch-On And Switch Off The Unit

    6.6.2. Switch-on and Switch-off the Unit Switch-on Hold down the POWER key for more than 2 seconds. A welcome screen is displayed. Then, the display will read the first file in the system last used before switching the device off. Switch-off Hold down the POWER key for more than 2 seconds.
  • Page 23: Auto Reverse Function

    6.6.4. Auto Reverse Function There are 3 different auto reverse modes: AUTO REVERSING: If, during operation the load reaches the preset torque limit value, the motor handpiece will automatically rotate in the reverse direction. When the load is removed, the motor handpiece returns to normal forward rotation automatically.
  • Page 24: Selecting A File System

    NOTES  This function is only available in continuous rotation.  This function is not activated during reverse rotation.  When the mark of remaining amount of battery indicates “ ”, the actual power supplied by the motor handpiece load may not be enough to reach the preset torque limit value.
  • Page 25: Reciprocating File Systems

    The angles of reciprocation are precise and specific to the design of the instrument and to the X-SMART Plus. If one of above mentioned reciprocating files has been chosen, the display reading below the system name will show RECIPROCATING.
  • Page 26: Program" For Continuous Rotary File Systems

    6.7.3. “Program” for Continuous Rotary File Systems For convenience, the device is delivered with 2 programs with default values of torque and speed (see chapter 13. Program – Individual Continuous Rotary Program). Press the FILE  key to select the next program number. Press the FILE ...
  • Page 27 If the MEMO key is not pressed to save the setting, the setting will be lost once a different file setting is selected. - 27 / 47 - FISDR-JAP / F1902124.EN / 07 / 2011 – updated 10/2016...
  • Page 28: Factory Default Parameters

    The torque setting can be adjusted from 0.6 to 4.0 Ncm in increments of 0.1 Ncm.The preset torque and speed values of all continuous rotary file systems can be altered individually. CAUTION Before using the motor handpiece, verify the correctness of the changed parameters. 6.8.
  • Page 29: Battery Refresh

    6.9. Battery Refresh Nickel Metal Hydride batteries can experience a decrease in charging capacity if repeated cycles of short-time use and recharging are carried out. This phenomenon is called the “memory effect”. The battery refresh function is used to resolve this phenomenon. 1.
  • Page 30: Maintenance

    When replacing, be sure to observe the following “PRECAUTIONS ON CHANGING BATTERY”. Note that Dentsply Maillefer shall not be held liable for any malfunction or failure resulting from the failure to follow the “PRECAUTIONS ON CHANGING BATTERY”. PRECAUTIONS ON CHANGING BATTERY ...
  • Page 31: Lubricating The Contra-Angle

    7. Close the battery cover. 8. Tighten the screw with a screwdriver. Do not apply excessive force when tightening. 9. Charge the battery before use. NOTE The used Nickel Metal Hydride batteries are recyclable, but their disposal may sometimes not be permitted by law in your location.
  • Page 32: Cleaning, Disinfection And Sterilization

    6.12. Cleaning, Disinfection and Sterilization 6.12.1. Foreword For hygiene and sanitary safety purposes, the contra-angle must be cleaned, disinfected and sterilized before each usage to prevent any contamination. This concerns the first use, as well as all subsequent uses. 6.12.2. General recommendations ...
  • Page 33: Step-By-Step Procedure

    6.12.3. Step-by-Step Procedure For contra-angle only. # Operation Operating Mode Warning 1 Preparation Remove the contra-angle from the motor handpiece and detach the files from the chuck. 2 Automated Put the contra-angle into the washer- - Avoid any contact between the contra- Cleaning with disinfector (Ao value >3000 or, at angle and any instruments, kits,...
  • Page 34: Technical Specifications

    Not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous dioxide.  Mode of operation: Continuous operation 7.2. Product Main Specifications X-SMART Plus control unit Model NE274/NE298 Torque range 0.6 - 4.0 Ncm in continuous rotation...
  • Page 35 X-SMART Plus motor handpiece Model EM09M Dimensions Ø 22.6 x L133.5 mm Weight 150 g (including motor handpiece cord) X-SMART Plus contra-angle Model Gear ratio File shank attachment Ø 2.35 mm ISO1797-1 Type1 Minimum fitting length of 11 mm shank...
  • Page 36: Error Code

    Error Code If the motor handpiece stops due to an abnormality such as a malfunction, overload or breakage due to misuse, it automatically checks the state of the control unit. It detects the cause of the abnormality and displays an error code on the LCD panel. If an error code is displayed, turn on the power again and check whether the same error code is displayed.
  • Page 37 Error Error Cause Check/Remedy code During E-00 Self-Check Malfunction of circuit. Contact your distributor. rotation of E-01 Over current The motor handpiece is locked Remove load. the motor (at the time of the auto reverse handpiece mode). The motor handpiece cord has Contact your distributor.
  • Page 38 Error Error Cause Check/Remedy code Other E-15 Abnormal heat The battery generates Replace the battery. generation from abnormal heat. If abnormal heat battery generates from the new battery as well, malfunction of the circuit may be suspected. Contact your distributor. E-16 LCD panel Faulty LCD.
  • Page 39: Troubleshooting

    When trouble is found, check the following points before contacting your distributor. If none of these are applicable or the trouble is not remedied even after action has been taken, the product may have failed. Contact your distributor. X-SMART Plus control unit and AC adapter Problem...
  • Page 40: Warranty

    Manufacturer warrants products to the original purchaser against defect in material and workmanship under normal practices of installation, use and servicing. X-SMART Plus is warranted for 36 months (exception: contra-angle & battery are covered by a 12 month warranty) from the date of purchase.
  • Page 41: Disposal Of The Product

    11. Disposal of the Product PLEASE DO NOT THROW AWAY! This product and all its components must absolutely be recycled through your distributor. 12. Identification of Symbols Serial number Manufacturer Date of manufacture Class II equipment Type B applied part Attention, consult operation instructions Consult instructions for use Recycling: PLEASE DO NOT THROW AWAY! : this product and all its components must...
  • Page 42: Program - Individual Continuous Rotary Program

    Program - Individual Continuous Rotary Program For your individual settings of torque and speed values, please write file sizes and the corresponding values in the following table (for details see chapter 6.7.3): File Position File type Program default settings: File Position To restore default parameters, see chapter 6.8.
  • Page 43: Appendix

    APPENDIX Electromagnetic Emissions and Immunity (English) Guidance and manufacturer's declaration - electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment. Emission test Conformity Electromagnetic environment - guidance...
  • Page 44 Guidance and manufacturer's declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment. IEC 60601 Electromagnetic environment - Immunity test Compliance level guidance...
  • Page 45 Guidance and manufacturer's declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should enssure that it is used in such an environment. IEC 60601 Compliance Immunity test Electromagnetic environment - guidance test level...
  • Page 46 Cables and Maximum Shield Connector Complies with accessories length RF emissions, CISPR11, Class B/ Group 1 Motor Handpiece 1.65 m Unshielded Plastic Harmonic emissions, IEC 61000-3-2, Class A cord Voltage fluctuations/ flicker emission IEC 61000-3-3 Electrostatic discharge (ESD) IEC 61000-4-2 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines...
  • Page 47 www.dentsplymaillefer.com Maillefer Instruments Holding Sarl Chemin du Verger 3 CH – 1338 Ballaigues Switzerland - 47 / 47 - FISDR-JAP / F1902124.EN / 07 / 2011 – updated 10/2016...