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Dentsply Sirona Propex IQ Directions For Use Manual

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Propex IQ
Apex Locator
Directions for Use
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Summary of Contents for Dentsply Sirona Propex IQ

  • Page 1 ® Propex IQ Apex Locator Directions for Use...
  • Page 2 PAGE INTENTIONALLY LEFT BLANK 2/74 BENPPIQDFUWEB / Rev.04 / 08-2018...

  • Page 3: Table Of Contents

    Modes of Operation ........19 ® Description of the Propex IQ Apex Locator ..... 21 6.5.1...
  • Page 4 Technical Characteristics ....... 48 ® Propex IQ Apex Locator Error Codes ..... 51 Troubleshooting .

  • Page 5: Introduction

    The DFU is available in other languages upon request. If a printed version in your language is not enclosed, Dentsply Sirona will send a free copy to any address in Europe. To order a free copy of the DFU, send a request to endo@dentsplysirona.com.

  • Page 6: Indications For Use

    To guarantee the safety, intended functionalities and good maintenance of Propex IQ Apex Locator, follow the indications given in the present Directions for Use (DFU). Keep the DFU updated as per described in the Introduction section. Dentsply Sirona will not ®...

  • Page 7: Warnings

    For US / EU readers. If nothing is indicated, the text is applicable to all of the intended territories. Dentsply Sirona accepts no liability in the event that any of these warnings are disregarded. Check the outer packaging seal on reception. Do not use the device if the packaging seal has been broken.
  • Page 8 Apex Locator will not provide correct information and the file clip could be damaged. • Use of gloves and of a rubber dam are mandatory during treatment. ® • Do not pour water or any other liquid over Propex IQ Apex Locator. 8/74 BENPPIQDFUWEB / Rev.04 / 08-2018...
  • Page 9 Disposable Barrier Sleeves is required (see section 7 Cleaning, Disinfection and Sterilization). Use only custom barriers ® provided by Dentsply Sirona made specifically for Propex IQ Apex Locator. • Always perform an X-ray and set the stopper to the determined working length ®...
  • Page 10 Warnings ® • If there is no audible sound or no visible flash of the LEDs when Propex IQ Apex Locator is switched on, do not use it. ® • Always switch off Propex IQ Apex Locator before cleaning it.
  • Page 11 ® • Always ensure that both Propex IQ Apex Locator and the iPad have sufficient ® battery charge before starting treatment. At low battery level, Propex IQ Apex Locator should not be used. See section 6.12 Battery Care. ® •...
  • Page 12 (e.g. if it has been dropped). Do not use it in case of malfunction, apparent breakage or cracks. The safety and effectiveness of the ® device can be seriously compromised. In cases of major shock, Propex IQ Apex Locator needs to be inspected by authorized technical personnel. Contact Dentsply Sirona Endodontics Customer Service for assistance.
  • Page 13 The use of accessories, transducers and cables other than those specified, with the ® exception of transducers and cables sold by the manufacturer of the Propex IQ Apex Locator or replacement parts for internal components, may result in increased ®...

  • Page 14: Precautions

    PRECAUTIONS Read the following precautions before use. ® • The manufacturer declines any responsibility in the case of using Propex IQ Apex Locator outside of its intended use or indications specified in this DFU. Please refer to sections 1 Indications for Use...

  • Page 15: Document Symbols

    Identification ® ® Consult Endo IQ App User Manual or Propex IQ Apex Locator Directions For If the instructions are not followed properly, operation may carry risks for the product or the user / patient Additional information, explanation on operation and performance...

  • Page 16: Package Contents

    ® Check that Propex IQ Apex Locator is supplied with all the components shown below and that all components are in good condition. List of components with Dentsply Sirona Stock Keeping Unit ® Propex IQ Apex Locator B00PPIQ000000 (supplied...
  • Page 17 Step by Step Instructions List of components with Dentsply Sirona Stock Keeping Unit ® Propex IQ Disposable Barrier Sleeve* (x 100) B00PPIQ1ACBAR (replacement polyethylene sleeves are supplied separately) ® Propex IQ Lip Clip (x 5) B00PPIQ5ACLCL ® Propex IQ File Clip (x 2) B00PPIQ2ACFCL ®...
  • Page 18 Step by Step Instructions ® Optional Propex IQ Clamp The device is delivered with an optional clamp (if available in your country), which can be installed on the back of the device with a screw (included in the package). The clamp can be installed with a standard flat / slot drive screwdriver (not included in the package).

  • Page 19: Assembling The Charger

    ® Propex IQ Apex Locator can be ® Working only with Propex IQ Apex Locator. ® used while X-Smart IQ Handpiece motor is rotating. ® The use of X-Smart IQ...
  • Page 20 X-Smart IQ Handpiece sleeve shown on the illustration For cable connection see 6.8.1 Plugging in For cable connection see 6.8.2 Plugging in ® ® the Propex IQ Measurement Cable in the X-Smart IQ Measurement Cable in uncombined mode. combined mode. ®...

  • Page 21: Description Of The Propex Iq ® Apex Locator

    Screw thread ® The screw thread provides the ability to connect a Propex IQ Clamp. Check with your distributor for more information about the clamp (if not included in the kit). The illustration above might slightly differ from the actual product.

  • Page 22: Description Of The Led Colors

    Very low battery level. Enough autonomy for approximately 5 minutes. Do not start a new treatment at this battery level. Critically low battery level. There is no autonomy left. Please ® recharge your Propex IQ Apex Locator. 22/74 BENPPIQDFUWEB / Rev.04 / 08-2018...
  • Page 23 Troubleshooting. Device test is on-going. Device test is successful. Device test (see 6.9.2 ® The LED is ON until the Propex IQ Device test) External Tester is unplugged. Device test failed. ® The LED is ON until the Propex IQ External Tester is unplugged.

  • Page 24: Description Of The Sounds

    6.10.3 Working length determination. ® ® X-Smart IQ Handpiece will rotate in reverse direction when Propex IQ Apex Locator is uncombined during a treatment and the Apical Reverse function is activated. 24/74 BENPPIQDFUWEB / Rev.04 / 08-2018...

  • Page 25: Plugging In The Propex Iq

    Plug in the Propex IQ Measurement Cable (2) to Propex IQ Apex Locator (1). ® ® Connect the Propex IQ Lip Clip (3) to the Propex IQ Measurement Cable (2). ® ® Connect the Propex IQ File Clip (4) to the Propex IQ Measurement Cable (2).

  • Page 26: Mode

    N° Action ® ® Only use X-Smart IQ Handpiece for working in combined mode. Using Propex IQ Apex Locator with another Handpiece can lead to severe electrical problems (including electrical shock). ® Insert X-Smart IQ Handpiece inside its proprietary single-use protective sleeve.

  • Page 27: Testing Propex Iq ® Apex Locator Functionality

    6.6 Description of the LED Colors. ® ® ® Connect the Propex IQ or X-Smart IQ Measurement Cable (2 or 5) to Propex IQ Apex Locator (1). ® ® ® Connect the Propex IQ Lip Clip (3) and the Propex IQ File Clip (4) or X-Smart IQ ®...

  • Page 28: Device Test

    ® ® Use the Propex IQ External Tester to test the basic functionality of the Propex IQ Apex Locator. Run this test periodically (e.g. once a week), after the device has not been used for a long period of time or for troubleshooting reasons (as per Section Troubleshooting).
  • Page 29 Unplug the Propex IQ External Tester from Propex IQ Apex Locator. Repeat the above procedure one more time). If the error persists DO NOT USE THE DEVICE and contact your Dentsply Sirona Endodontics Customer Service. BENPPIQDFUWEB / Rev.04 / 08-2018 29/74...

  • Page 30: Determining The Working Length

    Step by Step Instructions 6.10 Determining the Working Length 6.10.1 Definition The anatomical terminology is defined as follows: N° Description Coronal and medial regions. Region coronal to the reference point for working length determination. Reference point for working length determination. Region beyond reference point.

  • Page 31: Start Working Length Determination

    In case corrosion is present, use a new file clip (see Section Troubleshooting). ® For detailed steps on how to work with Propex IQ Apex Locator in uncombined and combined modes, refer to sections 6.10.4 Uncombined mode 6.10.5 Combined...
  • Page 32 Refer to Endo IQ App User Manual – 6 Step by Step Instructions. The position of the reference point can be adjusted with the “Shaping ® Target” function, which is only available when Propex IQ Apex ® ® Locator is connected to the Endo IQ App.

  • Page 33: Uncombined Mode

    Step by Step Instructions Color indication on ® Endodontic file progression Propex IQ Apex Locator Apical foramen (Major apical foramen or diameter) passed / over-instrumentation. Alarm condition: LED: Flashing red. Sound: Fast pulsating tones. Potential harm to the patient can be caused when this region is reached.
  • Page 34 Propex IQ Disposable Barrier Sleeve, with the long end of the barrier sleeve at the ® top. If you are using the optional Propex IQ Clamp on the back of the device, pull a second sleeve over the clamp as follows: ®...
  • Page 35 Step by Step Instructions Please note that the mandatory rubber dam is not shown in the schematic image below, for clarity’s sake. BENPPIQDFUWEB / Rev.04 / 08-2018 35/74...

  • Page 36: Combined Mode

    Disposable Barrier Sleeve, with the long end of the barrier sleeve at the ® ® top. If the optional Propex IQ Clamp is used, pull a second Propex IQ Disposable Barrier Sleeve over the clamp as illustrated in Section 6.10.4 Uncombined mode.
  • Page 37 Step by Step Instructions Please note that the mandatory rubber dam is not shown in the schematic image below, for clarity’s sake. The Handpiece sleeve supplied in your country may look different from the Handpiece sleeve shown on the illustration. BENPPIQDFUWEB / Rev.04 / 08-2018 37/74...

  • Page 38: Interruption Of File Progression Indication

    6.10.7 Tips for successful file progression indication ® Implausible, rapidly changing indications from Propex IQ Apex Locator may have various causes. Should you experience either situation, please review the below checklist to identify possible causes and take appropriate actions.

  • Page 39: Comparison Of Electronic Length Determination Versus Radiography

    / air- blower. May lead to incorrect feedback from Special condition symptom: exceptionally large ® apical foramen due to lesion or incomplete Propex IQ Apex Locator. Perform formation. radiography. May lead to incorrect feedback from ®...

  • Page 40: Stand-By Mode

    Apex Device active Locator ready to be used). ON/OFF/Standby LED emits a color corresponding to the battery status. ® Start using Propex IQ Stand-by mode Apex Locator. ON/OFF/Standby LED flashes and emits a color corresponding to the battery status. ®...

  • Page 41: Battery Care

    Do not charge the battery more than once a day. It is recommended that you charge the device at the end of each day. ® • Charge the battery overnight after using Propex IQ Apex Locator. The battery is fully charged after up to 6 hours of charging. •...

  • Page 42: Battery Replacement

    Always replace the batteries with two new batteries if they cannot be recharged correctly. The old batteries must be disposed of in accordance with local regulations. Fully charge the batteries before first use. Only use Dentsply Sirona batteries (part reference for EU: B00PPIQ2ACBAT, for US: T00PPIQ2ACBAT).

  • Page 43: Cleaning, Disinfection And Sterilization

    Apex Locator. The following parts shall be reprocessed before and after each treatment. ® The reprocessing procedure might damage the (USB) plugs connected to the Propex IQ ® Apex Locator / X-Smart IQ Handpiece ports. They are unlikely to be contaminated during normal (plugged) use.

  • Page 44: Cleaning Procedure

    N° Cleaning steps ® ® Propex IQ Apex Locator (and clamp, if used), Propex IQ Measurement Cable and X- ® Smart IQ Measurement Cable ® Switch off Propex IQ Apex Locator, then remove and discard the single-use ®...
  • Page 45 Replace the wipe and clean the brush when necessary. Cleaning of the file clip and lip clip – Cleaning and ultrasonic bath ® Place the pre-treated Propex IQ File Clip and Lip Clip into the cleaning bath for the ®...

  • Page 46: Disinfection

    Disinfect the surface of devices paying special attention to grooves and screws (and ® clamp, if used). Pay attention that no disinfectant enters the Propex IQ Apex Locator connector, e.g. by having the cable plugged-in. Use a single-use wipe or soft clean cloth lightly soaked in disinfectant containing Alcohol Quaternary Ammonium active ingredients (e.g.

  • Page 47: Sterilization Of The File Clip And Lip Clip

    Cleaning, Disinfection and Sterilization Sterilization of the File Clip and Lip Clip The sterilization process applies only to the lip clip and file clip. The maximum number of sterilization cycles is: • File clip: 120; • Lip clip: 120. Proceed with the sterilization as follows: N°...

  • Page 48: Technical Characteristics

    CH-1338 Ballaigues Switzerland Manufacturer Telephone +41 21 843 92 92 +41 21 843 92 93 endo@dentsplysirona.com dentsplysirona.com ® Model Propex IQ Apex Locator Length: 75 mm Dimensions Width: 46 mm Height: 20 mm • Charger cable: 2 m ® ®...
  • Page 49 Technical Characteristics Specification Description ® Single use Propex IQ Disposable Barrier Sleeve: Polyethylene ® Propex IQ Clamp: Stainless steel Material Rubber pad: SEBS Threaded insert: brass Grub screw: stainless steel A1 Rechargeable 2x AAA Ni-MH Batteries: Power supply Minimum capacity 750 mAh 1.2 VDC nominal;...
  • Page 50 Pressure: 50 kPa - 106 kPa Conditions for transport and storage ® • Do not subject Propex IQ Apex Locator to temperature shock. Let it warm up to room temperature for 24h after bringing it from a cold to a warmer environment.

  • Page 51: Propex Iq ® Apex Locator Error Codes

    Apex Locator Error Codes ® PROPEX IQ APEX LOCATOR ERROR CODES ® If a failure occurs on Propex IQ Apex Locator, the nature of the failure is given by a combination of colors and sounds as described in the following table. State Failure Solution ®...
  • Page 52 ® Propex IQ Apex Locator Error Codes State Failure Solution ® Connect to Endo IQ App for further information / Battery charge instructions. not sufficient to perform a ® See Endo IQ App User Manual - 6 Step firmware by Step Instructions.

  • Page 53: Troubleshooting

    If you are unable to solve the problem by referring to the checklist, contact Dentsply Sirona Endodontics Customer Service. ® Also refer to the error codes, which may be indicated on Propex IQ Apex Locator, as ® described in section...
  • Page 54 • Replace the batteries with a new original battery. • Electronic malfunction. • Perform a factory reset. • Contact Dentsply Sirona Endodontics Customer Service. • Send the device to Dentsply Sirona Endodontics Customer Service. 54/74 BENPPIQDFUWEB / Rev.04 / 08-2018...
  • Page 55 Troubleshooting ® No feedback from Propex IQ Apex Locator during treatment. Possible causes Solutions • The battery is completely empty (all LEDs • Connect the device to the charger and are OFF). charge the device. • The cables are damaged or not connected •...
  • Page 56 OFF). charge the device. • Electronic malfunction. • Perform a factory reset. • Send the device to Dentsply Sirona Endodontics Customer Service. Endodontic file progression indication is unstable or frozen. Possible causes Solutions • Calcified or obliterated root canal.
  • Page 57 LEDs damaged or not working properly. • Perform a factory reset. • Electronic malfunction. • Contact Dentsply Sirona Endodontics Customer Service. Endodontic file progression indication is too sensitive (i.e. it displays the relevant position for working length determination too quickly). Possible causes Solutions •...
  • Page 58 • Charger malfunction. • Replace the charger with an original charger. • Electronic malfunction. • Contact Dentsply Sirona Endodontics Customer Service. Device test and quick closed-loop test do not start. Possible causes Solutions • Perform a factory reset. ® •...
  • Page 59 Troubleshooting Apical Reverse function cannot be switched on. Possible causes Solutions ® • Ensure proper connection of the cables • No connection between Propex IQ Apex ® ® between Propex IQ Apex Locator and Locator and X-Smart IQ Handpiece. ®...

  • Page 60: Warranty

    The warranty does not extend to damage for which evidence can be provided by Dentsply Sirona that such damage has been caused by negligence on the part of the user as related to Directions For Use, particularly during battery charging or battery replacement.

  • Page 61: Disposal Of The Product

    Disposal of the Product DISPOSAL OF THE PRODUCT Comply with your national and regional regulations, guidelines and requirements for the disposal of end-of-life electrical equipment and batteries. Make sure the product or battery are not mixed with other types of waste when being disposed of.
  • Page 62 Identification of Symbols Symbol Identification Direct current (connection for power supply) Alternating current Sterilizable in a steam sterilizer (autoclave) at temperature specified Opened packages are not replaced Temperature limit Humidity limitation Keep dry Fragile; handle with care Accessory Use by date °...

  • Page 63: Appendix A: Electromagnetic Emissions And Immunity

    (see the following tables) and IEC 60601-1-2:2014 4th Edition ® (according to clause 7 and 8.9, tables 4 to 9). Propex IQ Apex Locator is a medical device that requires special safety precautions and must be installed and placed in operation in accordance with the below EMC information.
  • Page 64 Guidance and manufacturer’s declaration - electromagnetic emissions ® Propex IQ Apex Locator is intended for use in the electromagnetic environment specified below. ® The customer or the user of Propex IQ Apex Locator should ensure that it is used in such an environment. Emission test Compliance Electromagnetic environment - guidance ®...
  • Page 65 ® Propex IQ Apex Locator is intended for use in the electromagnetic environment specified below. ® The customer or the user of Propex IQ Apex Locator should ensure that it is used in such an environment. Immunity test Electromagnetic environment...
  • Page 66 IEC 61000-4-8 hospital environment. Portable and mobile RF communications equipment should be used no closer to ® any part of the Propex IQ Apex Locator, including cables, than the recommended separation Conducted RF 3 Vrms 3 Vrms...
  • Page 67 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 the Propex IQ Apex Locator is used exceeds the applicable ®...
  • Page 68 The Propex IQ Apex Locator is intended for use in the electromagnetic environment in which ® radiated RF disturbances are controlled. The customer or the user of the Propex IQ Apex Locator can help prevent electromagnetic interference by maintaining a minimum distance ®...
  • Page 69 WARNING: Portable RF communication equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm ® (12 inches) from any part of Propex IQ Apex Locator. Otherwise, degradation of the performance of this equipment could result.
  • Page 70 Appendix A: Electromagnetic Emissions and Immunity Enclosure port IMMUNITY TEST LEVELS BASIC EMC PROFESSIONAL PHENOMENON STANDARD OR TEST HEALTHCARE FACILITY TEST RESULTS METHOD ENVIRONMENT ± 8 kV CONTACT Electrostatic IEC 61000-4-2 ± 2 kV, ± 4 kV, ± 8 kV, Pass Discharge ±...
  • Page 71 Appendix A: Electromagnetic Emissions and Immunity Input a.c. power port IMMUNITY TEST LEVELS BASIC EMC PROFESSIONAL PHENOMENON STANDARD OR TEST HEALTHCARE FACILITY TEST RESULTS METHOD ENVIRONMENT ± 2 kV Electrical fast IEC 61000-4-4 100 kHz repetition Pass transients / bursts frequency a) l) o) a) b) j) o)
  • Page 72 Appendix A: Electromagnetic Emissions and Immunity a) The test may be performed at any one power input voltage within the ME EQUIPMENT or ME SYSTEM RATED voltage range. If the ME EQUIPMENT or ME SYSTEM is tested at one power input voltage, it is not necessary to re-test at additional voltages.
  • Page 73 Appendix A: Electromagnetic Emissions and Immunity o) Applicable to ME EQUIPMENT and ME SYSTEMS with RATED input current less than or equal to 16 A / phase and ME EQUIPMENT and ME SYSTEMS with RATED input current greater than 16 A / phase. p) Applicable to ME EQUIPMENT and ME SYSTEMS with RATED input current less than or equal to 16 A / phase.
  • Page 74 dentsplysirona.com Maillefer Instruments Holding Sàrl Chemin du Verger 3 CH-1338 Ballaigues 0086 Switzerland endo@dentsplysirona.com dentsplysirona.com BENPPIQDFUWEB / Rev.04 / 08-2018...

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