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FKG Rooter X3000 User Manual

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Summary of Contents for FKG Rooter X3000

  • Page 1 User Manual...

  • Page 3: Table Of Contents

    Power ON and power OFF the device ....................... 14 Select User Programs ..........................14 Set User Program parameters ........................15 Select FKG File Systems ..........................17 Set device parameters ..........................18 Torque overload protection ........................19 Apex locator limitations ..........................19 Troubleshooting ......................
  • Page 4 Maintenance ......................23 Calibration ..............................23 Lubrification of the contra-angle ....................... 23 Charging of the battery ..........................23 Replacement of the battery ........................23 Storage ........................24 Transportation ......................24 10. Environmental protection ..................24 11. After sales service ...................... 24 12.

  • Page 5: Product Introduction

    Product introduction Description of the device The Rooter ® X3000 device is a cordless endo motor with an integrated root canal apex locator. It can be used as an endo motor for preparation of tooth root canals, or as an apex locator device to help to determine the root canal working length.

  • Page 6: Components And Accessories

    Components and accessories Designation Reference FKG 08.971.00.001.FK Motor handpiece 08.971.00.002.FK Charging base 08.971.00.003.FK Contra-angle [4.7/1] 08.971.00.004.FK Spray noozle 08.971.00.005.FK Measuring wire 08.971.00.006.FK File clip 08.971.00.007.FK Lip hook 08.971.00.008.FK Touch probe 08.971.00.009.FK Protective silicone cover 08.971.00.010.FK "O"-ring 08.971.00.011.FK Universal AC-Adapter User manual...

  • Page 7: Technical Specifications

    Technical specifications a) Motor handpiece lithium battery specification 3.7V / 2000mAh b) Power adapter specification Input: ~100V-240V 50Hz/60Hz 0.5-0.2A Output: DC5V/1A c) Motor handpiece mechanical specification Torque range: 0.4Ncm-4.0Ncm Speed range: 100rpm-3’300rpm d) Wireless charging specification Frequency range: 112-205KHz Maximum RF output power of the product: 9.46dBuA/m@3m Warnings Please carefully read this Instruction Manual before first operation.

  • Page 8: Important Precautions

    Important precautions These precautions are critical to insure safe operation and use. a) Do not use this device on patients who have implanted pacemakers, defibrillators, or any other implantable devices. b) Do not use this device on patients suffering from Hemophilia. c) Use with caution on patients with heart disease, pregnant women, and young children.

  • Page 9: File Setup

    2. Push the contra-angle horizontally. A “click” sound indicates that the installation is in place. 3. The contra-angle must rotate 360° freely. Disconnecting the contra-angle 2.1.4 Pull out the contra-angle horizontally. File setup Warnings 2.2.1 a) Make sure the instruments are compliant to ISO1797 standard (Shanks for rotary and oscillating instruments).

  • Page 10: Apex Locator Setup

    Disconnecting a file 2.2.3 Hold down the Push button and pull out the file. Apex locator setup Warnings 2.3.1 a) In Apex locator mode, the file clip must properly hold the file. b) In case of bad or wrong connection signal, replace the measuring wire. c) In apex locator mode it is suggested to install the motor handpiece in the charging base to get better visual angle.
  • Page 11 d) The Apex locator detects the canal apical foramen, not the tooth anatomical apex. This could explain some differences between the apex locator signal and an X-ray image. e) Not all conditions are ideal for working length determination. To be informed about the Apex locator limitations, refer to Chapter 4.8.

  • Page 12: Device Operation Modes And Display Interface

    Connection testing 2.3.3 It is strongly recommended to check the connection quality before every use. 1. In Apex locator mode, clip the holder on lip hook and check that all the indicator bars light up, as shown below: 2. In combined Motor and Apex locator mode, touch the lip hook with the file and check that all the indicator bars light up, as shown below: Device Operation modes and display interface Motor modes...

  • Page 13: Apex Locator Operation Mode

    ATR Operation Mode (Adaptive Torque Reverse mode) 3.1.4 In this mode, the motor handpiece rotates in clockwise direction and generates reciprocating motion when the torque load on the file is higher than the set torque limit. Apex locator Operation mode EAL Operation Mode (Electronic Apex Locator) 3.2.1 This mode is intended for working length determination only.

  • Page 14: Display Interface

    Display interface Stand-by interfaces While the motor is not running, the display shows the actual settings of the motor. User Program (M0-M9) Manufacturer preset program (refer to Chapter 4.5) b. Battery level Set speed (rpm) d. Set torque limit (Ncm) e.

  • Page 15: Device Operating Instructions

    In stand-by state, the device will automatically shut down after 5 minutes. Select User Programs The device contains 10 memorized User Programs (M0-M9) and 7 preset FKG File Systems available directly from the stand-by state. 1. To select a program from the stand-by state, press the Adjusting button “+”/”-“.

  • Page 16: Set User Program Parameters

    Make sure all the parameters are verified before to start the motor handpiece. d) M0-M9 User Programs parameters modified by the user are memorized. e) FKG File Systems parameters cannot be modified by the user (refer to Chapter 4.5). Parameter setting 4.4.2...
  • Page 17 Set Apical Action The Apical action applies when the file reaches the set apical reference point (refer to Flash Bar Position) OFF: Disable Apical Action STOP: The motor stops automatically when the file reaches the reference point. The motor restarts automatically when the file is pulled away from the reference point. REVERSE: The motor automatically reverses the rotation direction when the file reaches the reference point.

  • Page 18: Select Fkg File Systems

    To help the user set the file parameters according to FKG recommendation, the most popular FKG File Systems are already preset in the device. 1. To select a preset FKG File System from the stand-by state, long press the Setting button “P”.

  • Page 19: Set Device Parameters

    R-Motion ® File systems selection File selection Stand-by interface Operation interface FKG File Systems parameters availability table 4.5.2 Parameter Set Flash Set Auto Set Auto Apical Working Torque Apical Forward Reverse Start Stop Slow Speed Limit Action Position Angle Angle...

  • Page 20: Torque Overload Protection

    Calibration Make sure the original contra-angle is installed before to launch the motor calibration. OFF: No action. ON: Start motor calibration The motor must be calibrated before the first use and after lubrification. Beeper volume The device sound volume can be adjusted from Vol. 0 to Vol. 4. Vol.0: Mute.
  • Page 21 Root canal with a large apical foramen Root canal with exceptionally large apical foramen due to a lesion or incomplete development might disturb the electrical signal. Root canal with liquid overflowing from the opening Root canal with blood or any other liquid overflowing from the opening and in contact with the gingival tissue might disturb the electrical signal.

  • Page 22: Troubleshooting

    Extremely dry root canal A dry canal might disturb the electrical signal. Troubleshooting Failure Possible cause Solutions The motor handpiece does not Device in EAL mode Changing to CW, CCW, REC or ATR rotate. mode. EAL mode is only for canal measurement.

  • Page 23: Step-By-Step Procedure

    c) Do not immerge the contra-angle in a disinfectant solution or in an ultrasonic bath. d) Do not use chloride detergent materials. e) Do not use bleach or chloride disinfectant materials. f) For your own safety, please wear personal protective equipment (gloves, glasses, mask). g) The user is responsible for the sterility of the product and of the instruments.

  • Page 24: Maintenance

    Storage Keep the accessories (contra- - Sterility cannot be guaranteed if packaging is angle, lip hook, file clip, touch open, damaged, or wet. probe, protective silicon cover) - Check the packaging and the contra-angle in sterilization packaging in a before use (packaging integrity, no humidity and dry and clean environment.

  • Page 25: Storage

    Warnings 7.4.1 a) Use original battery only. b) It is recommended to contact local distributors to replace the battery. Storage a) The device and accessories should be stored in a room where the relative humidity is 10% ~ 93%, atmospheric pressure is 70kPa ~ 106kPa, and the temperature is -20°C ~ +55°C. b) Remove the battery of the device in case of long period storage.

  • Page 26: Statement

    13. Statement All rights of modifying the product are reserved to the manufacturer without further notice. The pictures are only for reference. The final interpretation rights belong to GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD. The industrial design, inner structure, etc. have claimed for several patents by WOODPECKER, any copy or fake product must undertake legal responsibilities.

  • Page 27: Emc-Declaration Of Conformity

    14. EMC-Declaration of conformity The device has been tested and homologated in accordance with EN 60601-1-2 for EMC. This does not guarantee in any way that this device will not be affected by electromagnetic interference Avoid using the device in high electromagnetic environment. 14.1 Technical Description Concerning Electromagnetic Emission Table 1: Guidance &...
  • Page 28 IEC 61000-4-11 <5 % UT <5 % UT interruptions, it is recommended that the models Rooter X3000 be powered ® (>95% dip in UT.) (>95% dip in UT.) from an uninterruptible power supply or a battery. for 1 cycle for 1 cycle 70% UT 70% UT (30% dip in UT)
  • Page 29 NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
  • Page 30 Table 4: Recommended separation distances between portable and mobile RF communications equipment and the model Rooter ® X3000 The model Rooter ® X3000 is intended for use in electromagnetic environment in which radiated RF disturbances is controlled. The customer or the user of the model Rooter ®...
  • Page 32 Guilin Woodpecker Medical Instrument Co., Ltd. Information Industrial Park, Guilin National High-Tech Zone, Guilin, Guangxi, 541004 P. R. China Sales Dept.: +86-773-5873196 Http://www.glwoodpecker.com E-mail: woodpecker@glwoodpecker.com MedNet EC-Rep GmbH Borkstrasse 10 – 48163 Muenster - Germany ZMN-SM-027 Version 1.0 / 21.01.2021...

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