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BRASSELER USA HygienePro X Instructions For Use Manual

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Summary of Contents for BRASSELER USA HygienePro X

  • Page 1 Instructions for Use...

  • Page 2: Table Of Contents

    Contents 1. Introduction ..................................2. Scope of delivery ................................3. Safety notes ................................. 4. Description ................................... Foot control ................................Status LED handpiece drive ............................Status LED foot control ............................. 5. Start-up ..................................Charging the battery ..............................Query battery status ..............................Pairing ..................................
  • Page 3 Contents 12. Data on electromagnetic compatibility according to IEC/EN 60601-1-2 ................ 13. Disposal..................................Explanation of warranty terms ............................Authorized Brasseler service partners..........................
  • Page 4 Symbols WARNING! Thermo washer disinfectable Not for re-use (risk of injury) ATTENTION! Sterilizable Non-ionizing electromagnetic (to prevent damage up to the stated temperature radiation occurring) General explanations, Non-sterilizable Catalogue number without risk to persons or objects Follow instructions for use Class II medical Serial number electrical equipment...
  • Page 5 Symbols This way up MEDICAL – GENERAL “Der Grüne Punkt” (The Green MEDICAL EQUIPMENT AS Dot) trademark of Duales TO ELECTRICAL SHOCK, System Deutschland GmbH 25UX FIRE AND MECHANICAL HAZARDS ONLY IN Fragile, handle with care Trademark of RESY OfW ACCORDANCE WITH ANSI/ GmbH for identification of AAMI ES60601-1:2005/...
  • Page 6 Symbols FCC / IC – USA / Canada* This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

  • Page 7: Introduction

    Observe the safety notes. Indications for use HygienePro X: Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth surfaces and fillings. Misuse may damage the medical device and hence cause risks and hazards for patient, user and third parties.
  • Page 8 Introduction Hereby, the manufacturer declares that the medical device is in compliance with Directive 2014/53/EU (RED). The full text of the EU declaration of conformity is available at the following internet address https://wh.com Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device when it is used in compliance with the following directions: >...

  • Page 9: Scope Of Delivery

    2. Scope of delivery Description 5028510U0 HygienePro X Handpiece drive 5028513U0 HPX Charger 5028681U0 HPX Handpiece cradle Optional included in set 5028680U0 HPX-Foot Control with Stick 5028512U0 HPX-S Contra-angle head System Screw-in Young 5028511U0 HPX-D Handpiece head System Doriot...

  • Page 10: Safety Notes

    3. Safety notes > Before using the medical device for the first time, store it at room temperature for 24 hours. > Check the medical device for damage and loose parts each time before using. > Do not operate the medical device if it is damaged. >...
  • Page 11 Safety notes The medical device is classed as “conventional equipment” (closed equipment without protection against the ingress of water). The medical device is not approved for operation in potentially explosive atmospheres. Charger > Only use chargers approved by Brasseler. Hygiene and maintenance prior to initial use >...
  • Page 12 Safety notes Risks due to electromagnetic fields This medical device is suitable for use on patients with cardiac pacemakers, if a safety distance between the medical device and the cardiac pacemaker of at least 15 cm (5,9 inch) is maintained. The functionality of other active implantable medical devices (AIMD) (e.g.
  • Page 13 Safety notes The patient environment (see diagram) encompasses the area up to 2.50 m above the patient and 1.83 m in all horizontal directions 2,5 m The charger must not be used within the patient environment. 1,83 m 1,83 m...
  • Page 14 Safety notes Handpiece-/contra-angle head / Barrier sleeve > Use only the handpiece drive with the handpiece-/contra-angle head HPX-D, HPX-S. > Follow the directions and safety notes in the Instructions for Use of the handpiece-/contra-angle head. The barrier sleeves are disposable articles. >...

  • Page 15: Description

    4. Description Handpiece drive HygienePro X coupling for handpiece-/contra-angle head Status LED handpiece drive (see page 17) Status LED foot control (see page 18) Charging socket ON/OFF button...

  • Page 16: Foot Control

    Description Foot control Stick Charging LED (orange) Status LED (green) (see page 18 – 19) (see page 18, 21) Charging socket Reset button Pairing button...

  • Page 17: Status Led Handpiece Drive

    Description Status LED handpiece drive Standby mode > The handpiece drive can be activated with the ON/OFF button. > If the handpiece drive is not used for longer than 4 minutes, it returns to standby mode automatically. illuminated flashes flashes intermittently GREEN e Battery is 25–100 % charged e Pairing active...

  • Page 18: Status Led Foot Control

    Description Status LED foot control flashes flashes alternately ORANGE e Battery of foot control is flat e Pairing unsuccessful > Complete the treatment > Troubleshooting with pairing > Charge the battery of the foot control problems (see page 22) Standby mode >...

  • Page 19: Start-Up

    5. Start-up Charging the battery Charge the medical device fully before you use them for the first time. Attach the adaptor to the Connect the charging   power supply unit. cable into the foot control charging socket. LED orange: Battery is Plug the charger into an ...

  • Page 20: Query Battery Status

    Start-up Query battery status You can query the battery status when the handpiece drive is switched on and during the charging process. > Briefly press the ON/OFF button: flashes Battery status 3 x green 75–100 % 2 x green 50–75 % 1 x green 25–50 % orange...

  • Page 21: Pairing

    Start-up Pairing The foot control and handpiece drive are already paired when delivered! If pairing is active: Status LED (green) flashes on the foot control. > Both devices need to be in pairing mode for it to be possible to pair the handpiece drive and foot control. >...
  • Page 22 Start-up Pairing Troubleshooting with pairing problems > Remove any metallic objects located between the foot control and handpiece drive. > Change the position of the foot control. > Eliminate any sources of interference (e.g. brush motors, mobile telephones, radios, WLAN, ...) >...

  • Page 23: Assembly/Removal Of The Barrier Sleeve And Handpiece-/Contra-Angle Head

    Start-up Assembly/removal of the barrier sleeve and handpiece-/contra-angle head Place disposable barrier sleeve* over the internal shoulder of the  handpiece drive. Push the handpiece/-contra-angle head onto the handpiece drive.   Verify full engagement.     Remove the handpiece-/contra-angle head and barrier sleeve. ...

  • Page 24: Handpiece Drive

    6. Handpiece drive Operation Switch on Press the foot control  Press the ON/OFF button. to variably control the  speed of the rotary instrument. Press the foot control as far as it will go to attain the maximum speed of 3,000 rpm. The following light signals are shown on the foot control: Foot control pressed Status LED (green) flashes...
  • Page 25 Handpiece drive Operation Reverse operation For unscrewing the Screw-in Prophy Cups or Brushes. Hold the Cup or Brush firmly.  Keep pressed the ON/OFF button of the handpiece drive.   And press the foot control.    The Cup or Brush is unscrewed. ...

  • Page 26: Hygiene And Maintenance

    7. Hygiene and maintenance General notes Follow your local and national laws, directives, standards and guidelines for cleaning and disinfection. > Wear protective clothing, safety glasses, face mask and gloves. > Use only oil-free, filtered compressed air with a maximum operating pressure of 3 bar (43.5 psi) for manual drying.

  • Page 27: Limitations On Processing

    Hygiene and maintenance Limitations on processing The product lifetime and the medical device’s ability to operate correctly are mainly determined by mechanical stress during use and chemical influences due to processing. > Send worn or damaged medical devices and/or medical devices with material changes to an authorized Brasseler service partner.

  • Page 28: Initial Treatment At The Point Of Use

    Hygiene and maintenance Initial treatment at the point of use > Clean the medical device immediately after every treatment. > Wipe the entire handpiece drive and the handpiece cradle with disinfectant. > Brasseler recommends wiping down with disinfectant “CaviWipes ” (Metrex) (intermediate level). >...

  • Page 29: Manual Cleaning

    Hygiene and maintenance Manual cleaning > Do not place the handpiece drive and the handpiece cradle in liquid disinfectant or in an ultrasonic bath. > Do not immerse the handpiece drive in water or clean them under running water. Evidence of the handpiece drive’s basic suitability for effective manual cleaning was provided by an independent test laboratory using tap water <...

  • Page 30: Manual Disinfection

    Hygiene and maintenance Manual disinfection > Brasseler recommends wiping down with disinfectant. Evidence of the basic suitability of the handpiece drive and the handpiece cradle for effective manual disinfection (intermediate level) was provided by an independent test laboratory using the disinfectant “CaviWipes™” (Metrex).

  • Page 31: Automated Cleaning And Disinfection

    Hygiene and maintenance Automated cleaning and disinfection > The handpiece drive and the handpiece cradle are not approved for automated processing in a washer- disinfector and sterilization.

  • Page 32: Drying

    Hygiene and maintenance Drying > Ensure that the medical device is completely dry internally and externally after cleaning and disinfection. > Remove liquid residues using compressed air.

  • Page 33: Inspection, Maintenance And Testing

    Hygiene and maintenance Inspection, Maintenance and Testing > Check the medical device after cleaning and disinfection for damage, visible residual soiling and surface changes. > Reprocess any medical devices that are still soiled.

  • Page 34: Replacing The O-Ring

    8. Replacing the O-ring Do not use sharp tools! Squeeze the O-ring between your thumb and index finger firmly so that it forms a  loop. Pull the old O-ring off.  Push the new O-ring on in its place. ...

  • Page 35: Servicing

    9. Servicing Periodic inspection Regular periodic inspection of the function and safety of the medical device is necessary and should be carried out at least once every three years, unless shorter intervals are prescribed by law. The periodic inspection covers the complete medical device and must only be performed by an authorized service Partner.
  • Page 36 Servicing Repairs and returns In the event of operating malfunctions immediately contact an authorized Brasseler service partner. Repairs and maintenance work must only be undertaken by an authorized Brasseler service partner. > Ensure that the medical device has been completely processed before returning it. >...

  • Page 37: Brasseler Accessories And Spare Parts

    10. Brasseler Accessories and spare parts Use only original Brasseler accessories and spare parts or accessories approved by Brasseler. Supplier: Brasseler 08110780 5028681U0 01225100 5028513U0 HygieneProX HPX Handpiece cradle O-ring HPX Charger Handpiece drive 5028680U0 5028512U0 5028511U0 HPX-Foot Control with Stick HPX-S Contra-angle head HPX-D Handpiece head System Screw-in Young...

  • Page 38: Technical Data

    11. Technical data Ambient conditions Temperature during storage and transport: -20°C to +60°C (-4°F to +140°F) Humidity during storage and transport: 8% to 80% (relative), non-condensing Temperature during operation: +10°C to +35°C (+50°F to +95°F) Humidity during operation: 15% to 80% (relative), non-condensing Handpiece drive HygieneProX Battery type:...
  • Page 39 Technical data Frequency band: 2.4 GHz ISM band (2,402 – 2,480 GHz) Transmitting power: 3 dBm Modulation: GFSK Channels: 40 channels with 2 MHz spacing HPX Charger Rated voltage: 100 - 240 V Permissible voltage fluctuation: ± 10 % Frequency: 50 –...
  • Page 40 Technical data Classification according to Paragraph 6 of the General Specifications for the Safety of Medical Electrical Equipment according to IEC 60601-1/ANSI/AAMI ES 60601-1 Charger: Class II medical electrical equipment (protective earth conductor used for functional earth connection only!) Handpiece drive: Internally powered Type BF applied part (not suitable for intracardiac application) Pollution level: Overvoltage category:...

  • Page 41: Data On Electromagnetic Compatibility According To Iec/En 60601-1-2

    12. Data on electromagnetic compatibility according to IEC/EN 60601-1-2 Operating environment and EMC warning notes This medical device is neither life-sustaining nor coupled to the patient. It is suitable for operation both in domestic healthcare and in facilities used for medical purposes except rooms/areas, in which EMC interference of high- intensity may occur.
  • Page 42 Data on electromagnetic compatibility according to IEC/EN 60601-1-2 RF communication equipment Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to the medical device. Otherwise, degradation of the performance of this medical device could result.
  • Page 43 Results of the electromagnetic tests Requirement Class / Test Level* Electromagnetic emissions Mains terminal disturbance voltage (Conducted Emissions) Group 1 CISPR 11/EN 55011 [150 kHz – 30 MHz] Class B Electromagnetic radiation disturbance (Radiated Emissions) Group 1 CISPR 11/EN 55011 [30 MHz – 1000 MHz] Class B Harmonic distortion IEC/EN 61000-3-2 Class A...

  • Page 44: Disposal

    13. Disposal Ensure that the parts are not contaminated on disposal. Follow your local and national laws, directives, standards and guidelines for disposal. > Medical device > Waste electrical equipment > Packaging...

  • Page 45: Explanation Of Warranty Terms

    Ex p la na ti on o f war ranty ter ms This Brasseler medical device has been manufactured with great care by highly qualified specialists. A wide variety of tests and controls guarantees faultless operation. Please note that claims under warranty can only be validated when all the directions in the Instructions for Use have been followed.

  • Page 46: Authorized Brasseler Service Partners

    Authorized Brasseler service partners Brasseler U.S.A Dental, LLC One Brasseler Blvd. Savannah, GA 31419, USA 800.841.4522...
  • Page 48 Manufactured For: Brasseler U.S.A Dental, LLC One Brasseler Blvd. Form-Nr. 51074 AEN Savannah, GA 31419, USA Rev. 000 / 18.12.2023 800.841.4522 Subject to alterations MADE IN AUSTRIA B5822...

This manual is also suitable for:

5028510u0

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