Dentsply Sirona X-SMART IQ Directions For Use Manual
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Dentsply Sirona X-SMART IQ Directions For Use Manual

Dentsply Sirona X-SMART IQ Directions For Use Manual

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Summary of Contents for Dentsply Sirona X-SMART IQ

  • Page 1 X-Smart IQ ™ Directions for Use...
  • Page 2 PAGE INTENTIONALLY LEFT BLANK 2/88 T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018...

  • Page 3: Table Of Contents

    Table of contents Table of contents Introduction .........6 Indications for Use .
  • Page 4 Table of contents DENTSPLY ENDO IQ™Application ......36 6.7.1 Starting the Application ........36 6.7.2 Editing or creating a User Profile .
  • Page 5 Table of contents Technical Characteristics ......68 Motor Handpiece Error Code ......70 Troubleshooting .

  • Page 6: Introduction

    FOR DENTAL USE ONLY Introduction Congratulations on your purchase of the X-SMART IQ™ endo motor. These Directions for Use are always kept up to date by DENTSPLY Tulsa Dental Specialty Systems (hereafter Dentsply Sirona) to bring them in line with the latest developments. You will find the current version on www.dentsplysirona.com and...

  • 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. The device must only be used in hospital environments, clinics or dental offices, by qualified practitioners.

  • Page 8: Contraindications

    Contraindications Contraindications Read the following contraindications before use. • X-SMART IQ™ must not be used 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.)

  • Page 9: Warnings

    Read the following warnings before use. • The motor handpiece is intended for endodontic treatment and may only be used by trained and qualified dentists. • Do not use X-SMART IQ™ for implants or any other dental procedure outside endodontics. Environmental conditions •...
  • Page 10 30 cm (12 inches) to any part of the X-SMART IQ™ motor handpiece, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 11 • Gloves, a Custom Polyethylene Barrier over the handpiece (use only Custom Polyethylene Barriers provided by Dentsply Sirona made specifically for this handpiece), and a rubber dam are mandatory during treatment. • If any irregularities with the device should occur during treatment, switch it off.
  • Page 12 Pipeline and Hazardous Materials Safety Administration (PHMSA) site at http://www.phmsa.dot.gov/hazmat/ guidance. Contra-angle • Only use the original Dentsply Sirona contra-angle. • Contra-angles must be checked for damage before they are reused. Damaged products must be replaced. • Never press the contra-angle pushbutton when the motor handpiece is running or if it is coming to a stop.
  • Page 13 • Never use continuous rotary instruments in reciprocating mode. • Never use reciprocating instruments in rotary mode. iPad Mini™, iPad Mini™ protective case and motor handpiece support/cover • Dentsply Sirona recommends using the iPad Mini™ protective case indicated in 6.5.6 Setting up the Complete System. ®...
  • Page 14 The barrier is designed for single use and must be disposed of after use. • Do not place the X-SMART IQ™ motor handpiece in an autoclave unit or washer-disinfector. • The fast sterilization procedure and the sterilization procedure with non-packaged accessories are not permissible.
  • Page 15 • It is strongly recommended that all open applications are closed before launching the DENTSPLY ENDO IQ™ application. • Dentsply Sirona cannot be held liable for the developed application if unauthorized modifications have been made (e.g. jailbreaking). It is the user's responsibility to ensure that all patient information and data is protected in accordance with HIPAA regulations.
  • Page 16 • Repairs, alterations and modifications to the device are not permitted unless the manufacturer's prior consent has been obtained. Dentsply Sirona cannot be held liable if the device has been altered or modified. If a defect should occur, contact Dentsply Sirona or your Dentsply Sirona authorized...

  • Page 17: Precautions

    Precautions Precautions Read the following precautions before use. • Safety and effectiveness have not been established in pregnant women and children. • Please check the compatibility of your DENTSPLY ENDO IQ™ application before updating the iPad Mini™ operating system. • Always install the latest version of the DENTSPLY ENDO IQ™...

  • Page 18: Adverse Reactions

    Adverse Reactions Adverse Reactions There are no known adverse reactions. 18/88 T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018...

  • Page 19: Step By Step Instructions

    Step by Step Instructions Step by Step Instructions Refer to the chapter 3 Warnings 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 6.3 Package Contents.

  • Page 20: 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 21: Components Not Included

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

  • Page 22: Activating The Assistivetouch

    Step by Step Instructions 6.5.2 Activating the AssistiveTouch The AssistiveTouch feature replaces the actions of the iPad Mini Home button which is not accessible when in the ™ protective case. To activate the AssistiveTouch N° Action Select Settings. Select General. Select Accessibility.
  • Page 23 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 5 fingers to swipe in and to return to the Home screen. T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018 23/88...

  • Page 24: 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 25: 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°...

  • Page 26: Setting Up The Complete System

    Step by Step Instructions 6.5.6 Setting up the Complete System N° Action According to your iPad Mini™ model, use the suitable kit. Stick the foams of your kit at the places indicated on the protective case. Enclose and center the iPad Mini™ in the protective case. Place the corresponding plugs on the camera and the charging port.
  • Page 27 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. Ensure the motor is not running before connecting or disconnecting the contra-angle. Insert the contra-angle on the motor handpiece. Place the motor handpiece on its support.

  • Page 28: Motor Handpiece

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

  • Page 29: Description Of The Led Colors

    Step by Step Instructions 6.6.1.1 Description of the LED Colors Butto State Description n/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 30 Step by Step Instructions Butto State Description n/LED Second motor handpiece connected to the iPad Mini™. 6.7.3.1 Connecting a Second Motor Handpiece. Motor handpiece in stand-alone mode. 6.6.3 Stand-alone Mode. DENTSPLY ENDO IQ™ * Must use Application for initial set-up. Reciprocating motion mode active.

  • Page 31: The Auto Reverse (Autorev) Functionality

    Step by Step Instructions Butto State Description n/LED Low battery level. Sufficient charge to complete most cases. 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 the Sounds.

  • Page 32: 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 • The torque measured is about 75% over the defined rotation torque. Device running in Intermittent sound when: reciprocating •...

  • Page 33: Battery Care

    • If the battery is completely drained, charging can take up to six hours. • Continuous operation with the charger connected shortens the lifetime of the battery. Dentsply Sirona recommends working without the charging cable connected. • Autonomy: 2 days with 8 treatments per day or 16 total treatments.

  • Page 34: Inserting And Removing The File

    Step by Step Instructions 6.6.2 Inserting and removing the File 6.6.2.1 Inserting the File N° Action Insert the file ( ) into the chuck ( ) until it stops. Turn the file ( ) gently until it engages with the latch mechanism. Push inwards to click.

  • Page 35: Stand-Alone Mode

    Step by Step Instructions 6.6.3 Stand-alone Mode The motor handpiece can be used without connection to the iPad Mini™ and the DENTSPLY ENDO IQ™ application. This mode is called stand-alone mode. Initial set-up requires the use of the DENTSPLY ENDO IQ™ application, necessitating the motor handpiece being connected to the iPad Mini™...

  • Page 36: 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 Mini™ which includes the following features: • Treatment log and reporting system (see 6.7.6.1 Treatment Details). • File library (see 6.7.7 Customize File Sequences).

  • Page 37: 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 38: Connecting The Motor Handpiece

    Step by Step Instructions 6.7.3 Connecting the Motor Handpiece The motor handpiece and the iPad Mini™ communicate via ® Bluetooth N° Action ® Press the multifunction button until the Bluetooth LED blinks. ® Bluetooth LED blinks blue, see 6.6.1.1 Description of the LED Colors.
  • Page 39 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 40: 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 41: 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. The motor handpiece will use its stand-alone mode after a disconnection.

  • Page 42: Interface Presentation

    Start and Record Treatment Directions for 6.7.5.1 Motor Handpiece Information and Settings X-SMART IQ™ Warnings Home button, back to home screen Education Library 6.7.7 Customize File Sequences 6.7.6 Treatment Reports 6.7.5.2 Start Treatment 42/88 T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018...
  • Page 43 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 44 Step by Step Instructions The following labels are also present in the application: Button Action Continuous rotation mode. Reciprocating motion mode. ® Bluetooth connection level between the iPad Mini™ and the motor handpiece. Motor turning. Motor handpiece battery level. 44/88 T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018...

  • Page 45: Three Modes Of Use

    Step by Step Instructions 6.7.5 Three Modes of Use Stand-alone Mode Start and Record Start Treatment Treatment Must use X-SMART IQ™ Application for initial set- Using the motor handpiece Using the motor handpiece Using the motor handpiece with predefined sequences with predefined sequences...

  • Page 46: Motor Handpiece Information And Settings

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

  • Page 47: Start Treatment

    Step by Step Instructions 6.7.5.2 Start Treatment Click or swipe to move to next file To adjust the torque and speed or press the multifunction button. parameters Double press the multifunction Real time torque value button to move to the previous (displayed in a circular file bargraph)

  • Page 48: Start And Record Treatment

    Step by Step Instructions 6.7.5.3 Start and Record Treatment Dentsply Sirona cannot be held liable for the developed application if unauthorized modifications have been made (e.g. jailbreaking). It is the user's responsibility to ensure that all patient information and data is protected in accordance with HIPAA regulations.

  • Page 49: Treatment Reports

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

  • Page 50: Treatment Details

    Step by Step Instructions 6.7.6.1 Treatment Details Basic information for the record 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. 6.7.6.2 Treatment Notes To display a torque graph in real time Technical data of the files used for the treatment 50/88 T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018...

  • Page 51: Treatment Notes

    Step by Step Instructions 6.7.6.2 Treatment Notes The tooth numbering system can be changed in the system setup. Treated tooth Takes you back to To save the the previous page treatments without saving. To delete the treatment notes for the selected tooth To add an extra canal...

  • Page 52: 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 Sirona. The file sequences are divided into 3 categories: • Most frequently used sequences.
  • Page 53 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. T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018 53/88...

  • Page 54: 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 6.6.1.2 The Auto Reverse (AutoRev) Functionality File picture To save the created file File name...

  • Page 55: 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 56: 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 56/88 T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018...

  • Page 57: 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 58: Disinfection Of Motor Handpiece

    Cleaning, Disinfection and Sterilization Disinfection of Motor Handpiece The components listed on page 60 must be cleaned and subjected to a wipe-down with a disinfection wipe prior to and following each treatment. They are not approved for machine- based cleaning (Thermal Disinfection) or sterilization. Never place the components listed on page 60 in a washer-...
  • Page 59 (bactericidal and fungicidal) and use it to clean / disinfect all components. Dentsply Sirona recommends the use of DENTSPLY VoloWipes™. Thoroughly disinfect surfaces with a lightly soaked wipe (min. 30 seconds), making sure the entire surface is wetted, and allow to act (contact time >...
  • Page 60 Cleaning, Disinfection and Sterilization Motor handpiece iPad Mini™ protective case VoloWipes™ VoloWipes™ Spray nozzle VoloWipes™ Motor handpiece cover Motor handpiece support VoloWipes™ VoloWipes™ Charging cable VoloWipes™ 60/88 T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018...

  • Page 61: Lubrication Of The Contra-Angle

    30 min. of use, but at least once a day. Dentsply Sirona recommends the use of W&H Service Oil F1 MD- 400 Oil Spray Can, 400ml. When lubricating the contra-angle take care to ensure no oil gets into the motor handpiece.

  • Page 62: Cleaning, Disinfection And Sterilization Of The Contra-Angle

    Cleaning, Disinfection and Sterilization Cleaning, Disinfection and Sterilization of the Contra-Angle The contra-angle must be pre-cleaned, thermal-disinfected (if applicable) and sterilized prior to and following every treatment. Always start with preparation at the point of use and manual pre-cleaning in accordance with section 7.5.1 Pre-Treatment of the Contra-Angle.
  • Page 63 Cleaning, Disinfection and Sterilization Overview of Contra-Angle Cleaning, Disinfection and Sterilization Lubricate (for Pre- complete Clean DFU Section/ Method instructions, Temp / Time Dry Time / Wipe Page see Section down 7.4, page Thermal Drying disinfection performed Cleaning at For additional (if applicable).

  • Page 64: Pre-Treatment Of The Contra-Angle

    Cleaning, Disinfection and Sterilization 7.5.1 Pre-Treatment of the Contra-Angle Do not place the contra-angle in a disinfectant solution or in an ultrasonic bath. Wear protective gloves during preparation and transportation of the contra-angle. Use only cleaning agents that do not have a protein-binding effect.

  • Page 65: Machine-Based Reprocessing Of The Contra-Angle

    Cleaning, Disinfection and Sterilization 7.5.2 Machine-based Reprocessing of the Contra-Angle (Thermal-Disinfection) N° Operation Remarks Use washer-disinfector conforming to EN ISO 15883, e.g. Belimed WD, programme: Automatic cleaning / neutral. disinfection Use cleaning solution: e.g. 0.5% (v/v) Cleaning at 65°C deconex 24 LIQ, Borer Chemie. (149°F) holding time 5 min.

  • Page 66: Sterilization Of The Contra-Angle (Autoclaving)

    Cleaning, Disinfection and Sterilization 7.5.3 Sterilization of the Contra-Angle (Autoclaving) The fast sterilization procedure and the sterilization procedure with non-packaged accessories are not permissible. In addition, do not use hot-air sterilization, radiation sterilization or sterilization with formaldehyde, ethylene oxide or plasma. Always calibrate the motor handpiece after the contra-angle has been sterilized or exchanged.

  • Page 67: Sterilization Procedure Of The Contra-Angle

    Cleaning, Disinfection and Sterilization 7.5.3.1 Sterilization Procedure of the Contra-Angle Operation Remarks Clean and disinfect before sterilization. The Packaging contra-angle should also be lubricated before sterilization. Place the contra-angle in Make sure you only use dry sterile items. sterile barrier packages Use a sterilization temperature with tolerance in conforming to EN 868-5.

  • Page 68: Technical Characteristics

    Johnson City, TN 37604 USA  Manufacturer Phone: 1-800-662-1202 Fax: 1-800-597-2779 tulsacustserv@dentsplysirona.com www.dentsplysirona.com 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 Silicone ABS/PC...
  • Page 69 Technical Characteristics Specification Description Safety level in the presence of Not suitable for use in the presence flammable anesthetic gas mixtures or of flammable anesthetic gas oxygen mixtures or oxygen. Mode of operation Continuous and reciprocating • Use: in enclosed spaces; Ambient temperature: ...

  • Page 70: 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. Failure Solution State Re-initialize the motor handpiece with a Total system Factory Reset (see 6.6.1 Description of...
  • Page 71 Motor Handpiece Error Code Failure Solution State The Motor START/STOP Reset the device (see 6.6.1 Description button sensor of the Motor Handpiece). is not working properly Bluetooth Reset the device (see 6.6.1 Description radio module of the Motor Handpiece). failure Lubricate the contra-angle (see 7.5.3.1 Sterilization Procedure of the Contra-...

  • Page 72: 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, as described in chapter 9 Motor Handpiece Error Code.
  • Page 73 Troubleshooting Problem Cause / Solution iPad Mini™ switched off (empty battery). The handpiece keeps the last used settings for 5 min. You can either recharge the iPad Mini™ and reconnect the motor handpiece or use it in stand-alone mode. ® iPad Mini™...

  • Page 74: Warranty

    ** $0 cost for the first return. Additional returns will incur a $99 service fee. *** Dentsply Sirona reserves the right to replace 2nd and 3rd year returns with a refurbished motor. 74/88 T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018...

  • Page 75: Exclusion Of Liability

    11.1 Exclusion of Liability In the following cases the manufacturer declines all liability: • Use of X-SMART IQ™ for purposes and applications that differ from the specific requirements made in these Directions for Use. • Cleaning, disinfection and sterilization methods contrary to the directions in these Directions for Use.

  • Page 76: 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. Make sure the product or battery is not mixed with other types of waste when it is being disposed of. Prior to disassembly and disposal your device must not be contaminated and must have been completely reprocessed (Cleaning / Disinfection / Sterilization).

  • Page 77: 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 Do Not Throw Away. This product and all its components must be recycled.
  • Page 78 Identification of Symbols Symbol Identification Opened packages are not replaced Alternate current Temperature limit Humidity limitation Atmospheric pressure limitation Keep dry Fragile, handle with care Direct current (connection for power supply) Use by date ° Do not sterilize Do not re-use Caution, consult instructions for use Plastic Accessory...

  • Page 79: Electromagnetic Emissions And Immunity

    Electromagnetic Emissions and Immunity Electromagnetic Emissions and Immunity 14.1 Essential Performance The essential performance of the X-SMART IQ™ system was identified as driving a medical device such as an endodontic instrument in continuous rotary movement or an alternate reciprocating one with defined settings.

  • Page 80: Compliance With Emission And Immunity Standard

    Compliance with Emission and Immunity standard Guidance and manufacturer’s declaration - electromagnetic emissions X-SMART IQ™ is intended for use in the electromagnetic environment specified below. The customer or the user or X-SMART IQ™ should ensure that it is used in such an environment. Emission test...
  • Page 81 Electromagnetic Emissions and Immunity Guidance and manufacturer's declaration - electromagnetic immunity X-SMART IQ™ is intended for use in the electromagnetic environment specified below. The customer or the user of X-SMART IQ™ should ensure that it is used in such an environment. Immunity...
  • Page 82 Electromagnetic Emissions and Immunity < 5% U T (> 95% dip in < 5% U T ) for 0.5 (> 95% dip in U cycle for 0.5 cycle (at 0, 45, 90, (at 0, 45, 90, 135, 135, 180, 225 180, 225 and 315°...
  • Page 83 Electromagnetic Emissions and Immunity Guidance and manufacturer's declaration electromagnetic immunity X-SMART IQ™ is intended for use in the electromagnetic environment specified below. The customer or the user of X-SMART IQ™ should assure that it is used in such an environment. Immunity...
  • Page 84 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which X-SMART IQ™ is used exceeds the applicable RF compliance level above, X-SMART IQ™ should be observed to verity normal operation.
  • Page 85 Recommended separation distances between portable and mobile RF communications equipment and X-SMART IQ™ X-SMART IQ™ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of X- SMART IQ™ can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and X-SMART IQ™...
  • Page 86 Electromagnetic Emissions and Immunity Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment IMMUNITY Maximum Distance TEST Band power Service Modulation LEVEL (MHz) (V/m) Pulse 380 - TETRA 400 modulation 18 Hz 430 - GMRS 460, ± 5 kHz FRS 460 deviation 1 kHz sine...
  • Page 87 Electromagnetic Emissions and Immunity Bluetooth, WLAN Pulse 2400 – 802.11 b/g/ modulation 2570 n, RFID 217 Hz 2450, LTE Band 7 Pulse 5100 – WLAN modulation 5800 802.11 a/n 217 Hz NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m.
  • Page 88 www.dentsplysirona.com  Dentsply Tulsa Dental Specialties  Johnson City, TN 37604  USA     Phone: 1-800-662-1202  Fax: 1-800-597-2779   tulsacustserv@dentsplysirona.com Rx Only. www.dentsplysirona.com For Dental Use Only. T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018...

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