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Ultradent Ultrapro TX Cordless Instructions For Use Manual

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Instructions for Use

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Summary of Contents for Ultradent Ultrapro TX Cordless

  • Page 1 Instructions for Use...
  • Page 2 Contents...

  • Page 3: Table Of Contents

    ....................5 Preface .................5 Product Description ..........5 Indications for Use/Intended Purpose ................6 Contraindications ...............6 Warnings and Precautions ...............7 Stepwise Instructions ...................9 Maintenance ..................10 Processing ..............15 Storage and Disposal ............15 Technical Considerations ............21 Miscellaneous Information ..............22 Symbol Instruction...
  • Page 4 Charging station Disposable prophy angle Charging indicator Centralized control button Foot pedal Outer sheath Power adapter Motor component Disposable sleeve Battery indicator...

  • Page 5: Preface

    Tx Cordless hygiene handpiece. For the discerning dental professional ™ who values an untethered alternative to cleaning and polishing, the Ultrapro Tx Cordless handpiece cuts the cord and allows the user to perform prophylaxis flexibly while providing the patient a comfortable and high-quality cleaning experience.

  • Page 6: Contraindications

    • To avoid damage to lithium battery and control circuit, use original power adapter. • If you think a battery replacement is necessary, please contact Ultradent. Do not attempt to replace the battery. • To avoid damage, ensure that the device is in the off position before removing or installing the outer sheath or disposable prophy angle.

  • Page 7: Stepwise Instructions

    6. STEPWISE INSTRUCTIONS Wireless Connection of Foot Pedal Ensure that the foot pedal is fully charged before first use. If the handpiece is turned on, the Bluetooth will be paired automatically. The Bluetooth indicator will flash while the handpiece and the foot pedal are connecting. If the connection has failed, the Bluetooth indicator will keep flashing.
  • Page 8 INDICATOR PICTURE CHARGE LEVEL LED COLOR Battery full charged 3 green Charged 2/3 2 bottom indicators green and 1 top indicator off Charged 1/3 1 bottom indicator green and 2 top indicators off 1 bottom indicator orange and 2 top indicators Battery low off.

  • Page 9: Maintenance

    • Pull the old O-ring off and replace with a new O-ring. Warranty Ultradent hereby warrants that this instrument shall, for a period of 2 years*, conform in all material respects to the specifications therefore as set forth in Ultradent’s documentation accompanying the product and be free from any defects in materials/or workmanship.

  • Page 10: Processing

    8. PROCESSING The objective of the information provided in this section is to reduce the potential for patient cross contamination when using the device. Please follow all cleaning, disinfection, and sterilization procedures as recommended. • Sterilize the outer sheath prior to each use. Additional outer sheaths are available for purchase to accommodate uninterrupted patient procedures.
  • Page 11 INFECTION PART NAME PREVENTION Power Adapter Manual cleaning and Converts AC current into DC current required for charging the handpiece. disinfection Foot Pedal Manual cleaning and Provides a wireless control for rotation speed control of handpiece. It has two disinfection indicator lights.
  • Page 12 Instruction for Outer Sheath Cleaning and Sterilizing • The cleaning should be performed no later than 24 hours after treatment. The outer sheath can be cleaned by automated cleaning. • The outer sheath is not sterile upon receipt and must be steam autoclave sterilized prior to use in accordance with the following instructions.
  • Page 13 breakdown of the outer sheath over time. • The outer sheath has been designed for a large number of sterilization cycles. The materials used in manufacture were selected accordingly. However, with every renewed preparation for use, thermal and chemical stresses will result in aging of the products.
  • Page 14 Instruction for Cleaning and Disinfecting of the Motor Component, Charging Station, Foot Pedal, and Power Adapter Warnings • Do not sterilize the motor component, foot pedal, power adapter, or charging station. • The motor component, foot pedal, power adapter, and charging station cannot be cleaned and disinfected with automatic equipment.

  • Page 15: Storage And Disposal

    9. STORAGE AND DISPOSAL Store in a clean, dry, ventilated, non-corrosive atmosphere with a humidity of 10% to 93%, an atmospheric pressure of 70KPa to 106KPa, and a temperature of -20℃ to +55℃ . After sterilization, the product should remain bagged until ready for use. If the storage time exceeds 7 days, it may be necessary to run through autoclave before use.
  • Page 16 Ambient temperature: +5℃ ~ +40℃ Operating environment Relative humidity: 30% ~ 75% Atmospheric pressure: 70kPa ~106kPa Ambient temperature: -20℃ ~ +55℃ Transport and storage condition Relative humidity: 10% ~ 93% Atmospheric pressure: 70kPa ~106kPa Handpiece speeds Speed range: 500 rpm–4000 rpm (+/-10%) Foot pedal speeds Speed is controlled and adjusted through varying pressure on...
  • Page 17 1. Check for foreign matter between charging station and motor component. Motor component cannot be charged 2. Check whether the original power adapter is used. 1. Place the handpiece into the wireless charging base until the indicator light of the charging base flashes. Long press the on/off button on the handpiece while in the charging state.
  • Page 18 GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS The Ultrapro Tx Cordless handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of the Ultrapro Tx Cordless handpiece should ensure that it is used in such an environment.
  • Page 19 GUIDANCE & DECLARATION - ELECTROMAGNETIC IMMUNITY The Ultrapro Tx Cordless handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of the Ultrapro Tx Cordless handpiece should ensure that it is used in such an environment.
  • Page 20 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Ultrapro Tx Cordless handpiece is used exceeds the applicable RF compliance level above, the Ultrapro Tx Cordless handpiece should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Ultrapro Tx Cordless handpiece.

  • Page 21: Miscellaneous Information

    The Ultrapro Tx Cordless handpiece is intended for use in electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Ultrapro Tx Cordless handpiece can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Ultrapro Tx Cordless handpiece as recommended below, according to the maximum output power of the communications equipment.

  • Page 22: Symbol Instruction

    12. SYMBOL INSTRUCTION Follow Instructions for Use Serial number Date of manufacturing Manufacturer Type B applied part Class II equipment Handle with care Keep dry 106kPa Humidity limitation: indicates the Atmospheric pressure limitation: acceptable upper and lower limits of indicates the acceptable upper and relative humidity for transport and lower limits of atmospheric pressure storage...
  • Page 24 Manufactured for Ultradent Products, Inc. Made in China. 505 West Ultradent Drive (10200 South), South Jordan, Utah 84095. 1011506AR01 092222...

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