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Dentsply Maillefer X-SMART IQ User Manual

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Summary of Contents for Dentsply Maillefer X-SMART IQ

  • Page 1 User Manual...
  • Page 2 PAGE INTENTIONALLY LEFT BLANK 2/74 F1902142.EN / 05 / 2015 / updated 02/2016...

  • Page 3: Table Of Contents

    Table of contents Table of contents Introduction ......... . . 6 Indications for Use .
  • Page 4 Table of contents 6.6.3 Stand-alone mode: operation without the DENTSPLY ENDO IQ™ Application .......31 DENTSPLY ENDO IQ™Application .
  • Page 5 Table of contents Technical Characteristics ....... 63 Motor Handpiece Error Code ......65 Troubleshooting .

  • Page 6: Introduction

    Congratulations on your purchase of the X-SMART IQ™ endo motor. The User Manual is always kept up to date by Maillefer Instruments Holding Sàrl (hereafter Dentsply Maillefer) to bring it in line with the latest developments. You will find the current version on www.dentsplymaillefer.com and integrated into the DENTSPLY ENDO...

  • Page 7: Indications For Use

    Indications for Use Indications for Use X-SMART IQ™ is a cordless motor handpiece with torque control used for driving files in both reciprocating and continuous rotation mode during an endodontic procedure. 7/74 F1902142.EN / 05 / 2015 / updated 02/2016...

  • Page 8: Contraindications

    (such as electric shavers, hair dryers, etc.), X-SMART IQ™ must not be used. • Do not use X-SMART IQ™ for implants or any other dental procedure outside endodontics. • Safety and effectiveness have not been established in pregnant women and children.

  • Page 9: Warnings

    If this happens, the interference should be reduced by reorienting or repositioning the device or by screening off the immediate environment. The electromagnetic radiations emitted by the X-SMART IQ™ motor handpiece are below the recommended limits specified by the applicable relevant provisions (DIN EN 60601-1-2:2007).
  • Page 10 • Gloves and a rubber dam are absolutely essential during treatment. • If any irregularities with the device should occur during treatment, switch it off. Contact Dentsply Maillefer or your Dentsply Maillefer authorized service partner. Battery • Always use the original charger with the charging cable to charge the device.
  • Page 11 • Before treatment, check the contra-angle for any damage or loose parts. • Only use the original Dentsply Maillefer contra-angle. Root canal instruments • Before use, make sure the instrument is securely locked in place. •...
  • Page 12 Repairs, alterations and modifications to the device are not permitted unless the manufacturer's prior consent has been obtained. Dentsply Maillefer cannot be held liable if the device has been altered or modified. If a defect should occur, contact Dentsply Maillefer or your Dentsply Maillefer authorized service partner.
  • Page 13 • Leaking liquid can be an indicator of a defective battery. Standards and regulations that apply to the transport of X-SMART IQ™ Air freight Land freight • UN 3481 Lithium batteries in •...

  • Page 14: Precautions

    Precautions Precautions Read the following precautions before use. • Please check the compatibility of your DENTSPLY ENDO IQ™ ® application before updating the iPad operating system. • Always install the latest version of the DENTSPLY ENDO IQ™ ® application. Regularly check for updates on the App Store 14/74 F1902142.EN / 05 / 2015 / updated 02/2016...

  • Page 15: Adverse Reactions

    Adverse Reactions Adverse Reactions There are no known adverse reactions. Safety and effectiveness have not been established in pregnant women and children. 15/74 F1902142.EN / 05 / 2015 / updated 02/2016...

  • Page 16: Step By Step Instructions

    Step by Step Instructions Step by Step Instructions 3 Warnings Refer to the chapter to verify any special care to exercise before starting to use the complete device. Before use, please check the exact contents of the package. See Package Contents.

  • Page 17: Package Contents

    Carefully remove the device and the accessories from their packaging and place them on a flat surface. Check that the X-SMART IQ™ is supplied with all the components listed below. Not all components presented below are available in all kits.

  • Page 18: Components Not Included

    Step by Step Instructions Components not included The following components are not included in the kit: ® iPad with iOS app (not part of the kit). System Setup ® 6.5.1 Turning on the iPad and setting the Volume N° Action ®...

  • Page 19: Activating The Assistivetouch

    Step by Step Instructions 6.5.2 Activating the AssistiveTouch The AssistiveTouch feature replaces the actions of the iPad Home ® button which is not accessible when in the protective case. To activate the AssistiveTouch N° Action Select Settings. Select General. Select Accessibility. Select AssistiveTouch.
  • Page 20 Step by Step Instructions To press the Home button with AssistiveTouch N° Action Tap on the virtual home button. Select HOME. It is also possible to use the 4 fingers to swipe in and to return to the Home screen. 20/74 F1902142.EN / 05 / 2015 / updated 02/2016...

  • Page 21: Activating The Wifi

    Step by Step Instructions 6.5.3 Activating the WiFi You need to activate the WiFi to download the DENTSPLY ENDO IQ™ application. N° Action Select Settings. Select WiFi. Set WiFi to ON. Select your network and enter your password. ® 6.5.4 Activating the Bluetooth ®...

  • Page 22: Installing And Updating The Dentsply Endo Iq™ Application

    Step by Step Instructions 6.5.5 Installing and Updating the DENTSPLY ENDO IQ™ Application It is strongly recommended that data is backed up regularly by synchronizing with iTunes. ® The DENTSPLY ENDO IQ™ application is available in the App Store N° Action ®...

  • Page 23: Setting Up The Complete System

    Step by Step Instructions 6.5.6 Setting up the Complete System N° Action ® Enclose the iPad in the protective case and fit the rubber plugs. ® Pay attention to the iPad orientation. In case of error, use the red key to open the protective case. Separate the motor handpiece cover from the motor handpiece support.
  • Page 24 Step by Step Instructions N° Action Install the motor handpiece cover as a protective case holder. Place the assembly on a steady surface. Multiple configurations are possible. Insert the contra-angle on the motor handpiece. Turn off the motor before connecting or disconnecting the contra- angle.

  • Page 25: Motor Handpiece

    Step by Step Instructions Motor Handpiece 6.6.1 Description of the Motor Handpiece ® ® iPad /Motor handpiece Bluetooth connection status LED ►See 6.7.3 Connecting Motor Handpiece Motor START/STOP button Reciprocating motion mode status LED Continuous rotation Battery charge status LED mode status LED ►See 6.6.1.1 Description of...

  • Page 26: Description Of The Led Colors

    Step by Step Instructions 6.6.1.1 Description of the LED Colors Button State Description /LED Motor handpiece ready. Motor handpiece ready for calibration. Or motor handpiece in energy-saving mode. Motor handpiece turning. Motor handpiece turning in reverse. Or motor handpiece locked. Error detected.
  • Page 27 Step by Step Instructions Button State Description /LED ® Second motor handpiece connected to the iPad 6.7.3.1 Connecting a Second Motor Handpiece. Motor handpiece in stand-alone mode. 6.6.3 Stand-alone mode: operation without the DENTSPLY ENDO IQ™ Application. Reciprocating motion mode active. Continuous rotation mode active.

  • Page 28: The Auto Reverse (Autorev) Functionality

    Step by Step Instructions Button State Description /LED Low battery level. Connect the motor handpiece to the AC-adapter. 6.8 Storing and charging the Motor Handpiece. For acoustic signals, see 6.6.1.3 Description of Sounds. Very low battery level. Immediately connect the motor handpiece to the AC-adapter.

  • Page 29: Description Of The Sounds

    Step by Step Instructions 6.6.1.3 Description of the Sounds Mode Description Intermittent sound when: Device running in • The device is rotating in reverse. continuous rotation • The torque measured is about 75% over the defined torque. Device running in Intermittent sound when: reciprocating •...

  • Page 30: Battery Care

    If the battery is completely flat, charging can take up to six hours. • Continuous operation with the charger connected shortens the lifetime of the battery. Dentsply Maillefer recommends working without the charging cable connected. 6.6.2 Inserting and removing the File 6.6.2.1...

  • Page 31: Removing The File

    Step by Step Instructions 6.6.2.2 Removing the File N° Action Press the pushbutton ( ) and pull out the file ( 6.6.3 Stand-alone mode: operation without the DENTSPLY ENDO IQ™ Application ® The motor handpiece can be used without the iPad and the DENTSPLY ENDO IQ™...

  • Page 32: Dentsply Endo Iq™Application

    Step by Step Instructions DENTSPLY ENDO IQ™Application 6.7.1 Starting the Application ® DENTSPLY ENDO IQ™ is a multi-user iOS application for iPad which includes the following features: • A treatment log and reporting system (see 6.7.6.1 Treatment Details). • A file library (see 6.7.7 Customize File Sequences).

  • Page 33: Editing Or Creating A User Profile

    Step by Step Instructions 6.7.2 Editing or creating a User Profile The first time you use the application, you will be automatically connected as a default user. You can edit the profile with your data. If there is only one user defined, you will be automatically connected as this user.

  • Page 34: Connecting The Motor Handpiece

    Step by Step Instructions 6.7.3 Connecting the Motor Handpiece ® ® The motor handpiece and the iPad communicate via Bluetooth N° Action ® Press the multifunction button until the Bluetooth LED blinks. ® 6.6.1.1 Description of the LED Colors. Bluetooth LED blinks blue, see Wait until the motor handpiece is visible on the DENTSPLY ENDO IQ™...
  • Page 35 Step by Step Instructions N° Action Select the corresponding motor handpiece serial number from the pop-up. The serial number (2) can be found at the back of the motor handpiece. When the motor handpiece is connected : The icon (3) appears. ®...

  • Page 36: Connecting A Second Motor Handpiece

    Step by Step Instructions 6.7.3.1 Connecting a Second Motor Handpiece It is not possible to connect more than two motor handpieces to the DENTSPLY ENDO IQ™ application. If two motor handpieces are connected to the DENTSPLY ENDO IQ™ application, they have the same motor settings. A second motor handpiece can be connected to the DENTSPLY ENDO IQ™...

  • Page 37: Disconnecting The Motor Handpiece

    Step by Step Instructions 6.7.3.2 Disconnecting the Motor Handpiece N° Action Click on the icon (1). Select Disconnect (2) and confirm the operation. The motor handpiece disappears from the status bar. 37/74 F1902142.EN / 05 / 2015 / updated 02/2016...

  • Page 38: Interface Presentation

    ►See 6.7.5.3 Start and Record Treatment User Manual ►See 6.7.5.1 Motor Handpiece Information and Settings X-SMART IQ™ Warnings Home button, back to home screen Patient Education Library ►See 6.7.7 Customize File Sequences ►See 6.7.6 Treatment Reports ►See 6.7.5.2 Start Treatment 38/74 F1902142.EN / 05 / 2015 / updated 02/2016...
  • Page 39 Step by Step Instructions The following buttons are also present in the application: Button Action Takes you back to the previous page without saving. Save and leave the actual page. Patient information (see 6.7.6 Treatment Reports). Treatment notes (see 6.7.6.2 Treatment Notes).

  • Page 40: Three Modes Of Use

    Step by Step Instructions 6.7.5 Three Modes of Use Stand-alone Mode Start and Record Treatment Start Treatment Using the motor Using the motor Using the motor handpiece handpiece in one handpiece with predefined with predefined sequences predefined mode without sequences (default or (default or custom DENTSPLY ENDO IQ™...

  • Page 41: Motor Handpiece Information And Settings

    Step by Step Instructions 6.7.5.1 Motor Handpiece Information and Settings ® Bluetooth connection level Motor handpiece is ® between the iPad and the motor handpiece running Click on it to display the pop-up below: This symbol is blue for the first motor handpiece Motor handpiece battery connected and green for the second motor level...

  • Page 42: Start Treatment

    You can easily access "Start Treatment" by clicking on the Motor START/STOP button once the motor handpiece is connected to the X-SMART IQ™ application. Press the multifunction button on the motor handpiece to move to the next file. Double press to move to the previous file.

  • Page 43: Start And Record Treatment

    Step by Step Instructions 6.7.5.3 Start and Record Treatment The buttons and functions described in "Start Treatment" are also applicable to "Start and Record Treatment". To assign the current treatment to a patient To select the tooth on which the treatment is being carried out and add treatment notes.

  • Page 44: Treatment Reports

    Step by Step Instructions 6.7.6 Treatment Reports Treatment reports allow you to: • Create, edit or delete a patient. • View, edit or delete the treatments associated with the patients. To sort patients by names To select the current user's patients To sort patients by treatment date (Mine) or all users' patients (if multiple users defined)

  • Page 45: Treatment Details

    Step by Step Instructions 6.7.6.1 Treatment Details Basic information for the patient and specific information for the associated treatment To create and send a PDF report by email To delete the treatment To review your treatment notes. ►See 6.7.6.2 Treatment Notes To display a torque graph in real time Technical data of the files used for the treatment...

  • Page 46: Treatment Notes

    Step by Step Instructions 6.7.6.2 Treatment Notes Treated tooth Takes you back to the To save the treatments previous page without saving. To delete the treatment Information related to the treatments: Canal type, Length, Obturation Method, File and Note. 46/74 F1902142.EN / 05 / 2015 / updated 02/2016...

  • Page 47: Customize File Sequences

    6.7.7 Customize File Sequences A file sequence is a collection of files that are used during a treatment. It is composed of files provided by Dentsply Maillefer or a third-party manufacturer. The file sequences are divided into 4 categories: •...
  • Page 48 Therefore, the preset values in the library must be checked prior to use. Torque values shown on the application are accurate and reliable only if the X-SMART IQ™ 6:1 contra-angle is properly maintained and lubricated. 48/74 F1902142.EN / 05 / 2015 / updated 02/2016...

  • Page 49: Create New File

    Step by Step Instructions 6.7.7.1 Create new File File color Indicates the type of rotation for the file Continuous Rotation File Systems Selection of the Auto Reverse Function mode. Reciprocating File Systems ►See 6.6.1.2 The Auto Reverse (AutoRev) Functionality File picture To save the created file File name...

  • Page 50: Create File Sequence

    Step by Step Instructions 6.7.7.2 Create File Sequence The standard file sequence can not be edited or deleted but it is possible to create a copy that can be edited. A custom file can only be deleted if not used in any sequence. Select the file system for your sequence.

  • Page 51: Storing And Charging The Motor Handpiece

    Step by Step Instructions Storing and charging the Motor Handpiece N° Action Store the motor handpiece in the motor handpiece holder Plug in the motor charger. Fit the motor handpiece cover. Charging time: maximum 6 hours 51/74 F1902142.EN / 05 / 2015 / updated 02/2016...

  • Page 52: Cleaning, Disinfection And Sterilization

    Cleaning, Disinfection and Sterilization Cleaning, Disinfection and Sterilization Foreword Regular maintenance of X-SMART IQ™ is essential to ensure that work performed is completely hygienic and that the device will have a long service life. The components of X-SMART IQ™ have not been disinfected or sterilized when they are delivered.
  • Page 53 After any pre-cleaning, lightly soak a paper tissue or soft cloth in a mild, aldehyde-free disinfection and cleaning solution (bactericidal and fungicidal) and use it to clean/disinfect all components. ® Dentsply Maillefer recommends mikrozid AF wipes manufactured by Schülke. Thoroughly disinfect surfaces with a soaked wipe (min. 30 seconds), making sure the entire surface is wetted, and allow to act (contact time >...
  • Page 54 Cleaning, Disinfection and Sterilization Motor handpiece ® iPad protective case Spray nozzle Motor handpiece cover Motor handpiece support Charging cable 54/74 F1902142.EN / 05 / 2015 / updated 02/2016...

  • Page 55: Cleaning, Disinfection And Sterilization Of The Contra-Angle

    Pre-Treatment. Sterilize the contra-angle after you have performed manual or machine-based cleaning and disinfection and then lubricate. Dentsply Maillefer recommends device-based cleaning in a washer- disinfector. Please refer to the manufacturer’s information concerning equipment, cleaning agents and rinsing agents. Frequent reprocessing has minimal effects on the service life of contra-angles.

  • Page 56: Pre-Treatment

    Cleaning, Disinfection and Sterilization 7.4.1 Pre-Treatment N° Operation Remarks Wear protective gloves when you prepare and transport the contra- angle. Preparation at the place of use No special transport container is required for the Remove the root canal contra-angle. Transport is not subject to any instrument and separate special requirements.

  • Page 57: Manual Reprocessing

    Use a cleaning tool (brush). (100.4°F)). Remove any liquid residues (ultra-absorbent cloth, particle-free compressed air). Manual disinfection For disinfection purposes, Dentsply Maillefer Thoroughly disinfect ® recommends the use of mikrozid AF wipes surfaces with a soaked manufactured by Schülke. wipe, making sure the...

  • Page 58: Machine-Based Reprocessing

    Cleaning, Disinfection and Sterilization 7.4.3 Machine-based Reprocessing If you clean and disinfect the contra-angle in a machine, heed the instructions below and proceed as follows: N° Operation Remarks Use washer-disinfector conforming to EN ISO 15883, e.g. Belimed WD, programme: Automatic cleaning / neutral.

  • Page 59: Lubrication Of The Contra-Angle

    Lubricate the contra-angle immediately after thermal disinfection. Use the spray nozzle included to lubricate the contra-angle. Dentsply Maillefer recommends reprocessing the contra-angle using a fully automatic reprocessing device, e.g. the Assistina from W&H. Please perform the following steps to lubricate the contra-angle: N°...
  • Page 60 Cleaning, Disinfection and Sterilization Contra-angle trial run after lubrication: N° Action Attach the contra-angle to the motor handpiece. Hold the motor handpiece upside down. Run the motor handpiece for 30 seconds to remove any excess oil. If dirt emerges, repeat the entire cleaning and disinfection process and start the lubrication process again.

  • Page 61: Sterilization

    Cleaning, Disinfection and Sterilization 7.4.5 Sterilization N° Operation Remarks Packaging Shrink wrap the contra- Conforming to EN 868-5. angle in sterile barrier packages. Clean and disinfect before sterilization. The Sterilization contra-angle should also be lubricated before Sterilize at a maximum sterilization.

  • Page 62: Approved Sterilization Procedure

    Cleaning, Disinfection and Sterilization 7.4.5.1 Approved Sterilization Procedure N° Operation Remarks Sterilization Steam sterilization with Comply with your national guidelines, standards fractionated pre-vacuum and requirements for cleaning, disinfection and method B. sterilization. Sterilization at 132°C (269.6°F) for at least 4 Steam sterilization in accordance with EN 13060 min.

  • Page 63: Technical Characteristics

    Description Maillefer Instruments Holding Sàrl Chemin du Verger 3 Manufacturer CH-1338 Ballaigues Switzerland Model X-SMART IQ™ Dimensions (Length x Height x Width) 206 mm x 24.6 mm x 24.8 mm PBT / PET Stainless steel 316L TPE (thermoplastic elastomer) Material...
  • Page 64 Technical Characteristics Specification Description • Use: in enclosed spaces; Ambient temperature:  • 15°C - 35°C; (59°F - 95°F) • Relative humidity: < 80%; non- condensing at 0°C; Ambient conditions • Operating altitude < 2 000 m (~ 6561ft 8in) above sea level;...

  • Page 65: Motor Handpiece Error Code

    Motor Handpiece Error Code Motor Handpiece Error Code If a failure occurs on the motor handpiece, the nature of the failure is given by a combination of colors as described in the following table. State Failure Solution Re-initialize the motor handpiece with a Total system 6.6.1 Description of the Factory Reset (see...
  • Page 66 Motor Handpiece Error Code State Failure Solution The Motor START/STOP 6.6.1 Description of Reset the device (see button sensor the Motor Handpiece). is not working properly 6.6.1 Description of Bluetooth radio Reset the device (see the Motor Handpiece). module failure 7.4.4 Lubricate the contra-angle (see Lubrication of the...

  • Page 67: Troubleshooting

    Troubleshooting Troubleshooting If the device is not operating properly, read the following checklist. If you are unable to solve the problem by referring to the checklist, contact your service center. Also refer to the any error codes which may be indicated on the device, 9 Motor Handpiece Error Code.
  • Page 68 Troubleshooting Problem Cause / Solution ® iPad switched off (empty battery). The handpiece keeps the last used settings for 5 min. You ® can either recharge the iPad and reconnect the motor handpiece or use it in stand-alone mode. Lost connection ®...

  • Page 69: Warranty

    Full performance capability of X-SMART IQ™ is covered by a 12-month warranty and that of the contra-angle is covered by a 24-month warranty that commences on the date of delivery to the customer (as indicated on the delivery documents bearing the serial number of the product, issued by the seller upon sale).

  • Page 70: Exclusion Of Liability

    Warranty The warranty explicitly excludes defects that: • have been caused by damage in transit to Dentsply Maillefer/to a service partner authorized by Dentsply Maillefer for the purpose of repair; • have been caused by atmospheric events such as lightning strike, fire and moisture.

  • Page 71: Disposal Of The Product

    Disposal of the Product Disposal of the Product Comply with your national regulations, guidelines and requirements for the disposal of end-of-life electrical equipment and batteries. Specialist dental dealers will be pleased to provide you with country-specific information concerning disposal. Make sure the product or battery is not mixed with other types of waste when it is being disposed of.

  • Page 72: Identification Of Symbols

    Identification of Symbols Identification of Symbols 13.1 Normative Symbols Symbol Identification Serial number Lot number Catalogue number Refer to instruction manual / booklet Electronic instruction for use Date of manufacture Manufacturer Class II equipment Type BF applied part Recycling: PLEASE DO NOT THROW AWAY! This product and all its components must absolutely be recycled through your distributor Direct current (connection for power supply) 134 C...
  • Page 73 Identification of Symbols Symbol Identification Opened packages are not replaced CE Mark 0459 Alternate current Temperature limit Humidity limitation Atmospheric pressure limitation Keep away from rain Fragile, handle with care Accessory Use by date ° Do not sterilize Do not re-use Caution, consult accompanying documents Plastic 73/74...
  • Page 74 www.dentsplymaillefer.com Maillefer Instruments Holding Sàrl Chemin du Verger 3 CH-1338 Ballaigues Switzerland email: info@dentsplymaillefer.com F1902142.EN / 05 / 2015 / updated 02/2016...

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