W&H proxeo TWIST Manual
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W&H proxeo TWIST Manual

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Instructions for use
PL-40 H

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Summary of Contents for W&H proxeo TWIST

  • Page 1 Instructions for use PL-40 H...

  • Page 2: Table Of Contents

    Contents Symbols .......................................... 4 1. Introduction ....................................... 7 2. Scope of delivery ....................................... 9 3. Safety notes ......................................10 4. Description....................................... 15 Handpiece drive ....................................15 Foot control C-NW ....................................16 Status LED handpiece drive ................................17 Status LED foot control ..................................18 5.
  • Page 3 Contents Sterilization ......................................35 Storage ........................................ 36 8. Replacing the O-ring ....................................37 9. Servicing ........................................38 10. Accessories, consumables, spare parts and other recommended medical devices by W&H ............40 11. Technical data ......................................41 12. Data on electromagnetic compatibility according to IEC/EN 60601-1-2 ..................44 13.

  • Page 4: Symbols

    Symbols WARNING! CE mark Not for re-use (risk of injury) with identification number XXXX of the Notified Body ATTENTION! Medical device Non-ionizing electromagnetic (to prevent damage occurring) radiation General explanations, Thermo washer disinfectable Catalogue number without risk to persons or objects Follow instructions for use Sterilizable...
  • Page 5 Symbols Not suitable for intracardiac MEDICAL – GENERAL MEDICAL “Der Grüne Punkt” (The Green application – Type BF appliance EQUIPMENT AS TO ELECTRICAL Dot) trademark of Duales 25UX SHOCK, FIRE AND MECHANICAL System Deutschland GmbH HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601- Data Matrix code Trademark of RESY OfW GmbH 1:2005/(R)2012 + A1:2012 +...
  • Page 6 Symbols RCM – Australian / New Zealand ANATEL – Brazil GITEKI (MIC) – Japan 209 - J00204 FCC / IC – USA / Canada...

  • Page 7: Introduction

    1. Introduction For your safety and the safety of your patients These Instructions for Use explain how to use your medical device. However, we must also warn against possible hazardous situations. Your safety, the safety of your team and, of course, the safety of your patients are of paramount importance to us. Observe the safety notes.
  • Page 8 Introduction Hereby, W&H 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 30317000 Handpiece drive 07969610 Charger with adaptor 05882600 Handpiece holder Optional included in set 30316000 Foot control C-NW with Stick...

  • 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 W&H. 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 2,5 m The charger must not be used within the patient environment. 1.83 m 1.83 m 1,83 m 1,83 m...
  • Page 14 Safety notes Prophy Angle The Prophy Angles are disposable articles. > Use only Prophy Angles which are in perfect condition. Follow the operating instructions of the manufacturer. > Insert the Prophy Angle only when the medical device is stationary. > Never touch the Prophy Angle while it is still rotating. >...

  • Page 15: Description

    4. Description Handpiece drive Coupling for Handpiece sleeve Prophy Angle Status LED handpiece drive (see page 17) Status LED foot control (see page 18) Nose Charging socket ON/OFF button...

  • Page 16: Foot Control C-Nw

    Description Foot control C-NW 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 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. steady 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 problems > Charge the battery of the foot control (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 cable power supply unit. into the foot control charging socket. LED orange: Battery is ...

  • 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 Prophy Angle

    Start-up Assembly/removal of the Prophy Angle Prophy Angle Cup or Brush  Position the groove on the Prophy Angle with the nose of the handpiece drive.  Push the Prophy Angle onto the handpiece drive until the limit stop. Verify full engagement. ...

  • Page 24: Handpiece Drive

    6. Handpiece drive Switch on/off Switch on  Press the foot control to  Press the ON/OFF button. variably control the speed of the disposable contra-angle handpiece. 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: Test Run

    Handpiece drive Test run Do not hold the handpiece drive at eye level! > Attach the Prophy Angle to the handpiece drive. > Operate the handpiece drive with the foot control. In the event of operating malfunctions (e.g., vibrations, unusual noise, overheating) stop the medical device immediately and contact an authorized W&H service partner.

  • Page 26: Hygiene And Maintenance

    7. Hygiene and maintenance General notes Follow your local and national laws, directives, standards and guidelines for cleaning, disinfection and sterilization. > Wear protective clothing, safety glasses, face mask and gloves. Cleaning agents and disinfectants > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of cleaning agents and/or disinfectants.

  • 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 W&H 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, the handpiece sleeve and the handpiece holder with disinfectant. > Ensure that no fluids enter the medical device. >...

  • Page 29: Manual Cleaning

    Hygiene and maintenance Manual cleaning > Do not place the handpiece drive, the handpiece sleeve and the handpiece holder 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 > W&H recommends wiping down with disinfectant. Evidence of the basic suitability of the handpiece drive, the handpiece sleeve and the handpiece holder for effective manual disinfection was provided by an independent test laboratory using the “mikrozid® AF wipes” disinfectant (Schülke &...

  • Page 31: Automated Cleaning And Disinfection

    Hygiene and maintenance Automated cleaning and disinfection Handpiece sleeve W&H recommends automated cleaning and disinfection using a washer-disinfector (WD). Read the notes, follow the instructions and heed the warnings provided by the manufacturers of washer-disinfectors, cleaning agents and/or disinfectants. > The handpiece drive and the handpiece holder are not approved for automated processing in a washer-disinfector and sterilization.
  • Page 32 Hygiene and maintenance Drying > Ensure that the medical device is completely dry internally and externally after cleaning and disinfection. > Remove any 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. > Sterilize the handpiece sleeve following cleaning and disinfection.

  • Page 34: Packaging

    Hygiene and maintenance Packaging Handpiece sleeve Pack the handpiece sleeve in sterilization packages that meet the following requirements: > The sterilization package must meet the applicable standards in respect of quality and use and must be suitable for the sterilization method. >...

  • Page 35: Drying

    Hygiene and maintenance Sterilization Handpiece sleeve W&H recommends sterilization according to EN 13060, EN 285 or ANSI/AAMI ST55. > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of steam sterilizers. > The program selected must be suitable for the handpiece sleeve. Recommended sterilization procedures >...

  • Page 36: Storage

    Hygiene and maintenance Storage Handpiece sleeve > Store sterile goods dust-free and dry. > The shelf life of the sterile goods depends on the storage conditions and type of packaging.

  • Page 37: Replacing The O-Ring

    8. Replacing the O-ring Do not use sharp tools!  Pull the handpiece sleeve off the handpiece drive.  Squeeze the O-ring between your thumb and index finger firmly so that it forms a loop.  Pull the old O-ring off. ...

  • Page 38: 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 39 Servicing Repairs and returns In the event of operating malfunctions immediately contact an authorized W&H service partner. Repairs and maintenance work must only be undertaken by an authorized W&H service partner. > Ensure that the medical device has been completely processed before returning it. >...

  • Page 40: Accessories, Consumables, Spare Parts And Other Recommended Medical Devices By W&H

    Accessories, consumables, spare parts and other recommended medical devices by W&H Use only original W&H accessories and spare parts or accessories approved by W&H. Supplier: W&H partners 07954780 05882600 07918800 02695700 Handpiece drive Handpiece holder Handpiece sleeve O-ring (3 pcs) 07969610 07979710 07994950...

  • Page 41: Technical Data

    11. Technical data Ambient conditions Temperature during storage and transport: -20°C bis +60°C (-4°F to +140°F) Humidity for storage and transport: 8% to 80% (relative), non-condensing Temperature in operation: +10°C to +35°C (+50°F to +95°F) Humidity in operation: 15% to 80% (relative), non-condensing Handpiece drive PL-40 H Battery type:...
  • Page 42 Technical data Freuquency band: 2.4 GHz ISM band (2,402 – 2,480 GHz) Transmitting power: 3 dBm Modulation: GFSK Channels: 40 channels with 2 MHz spacing Charger Rated voltage: 100 - 240 V Permissible voltage fluctuation: ± 10 % Frequency: 50 – 60 Hz Power: 7 VA...
  • Page 43 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 44: 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 45 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 46 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 47: 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 48: Explanation Of Warranty Terms

    Ex p la na ti on o f war ranty ter ms This W&H 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 49: Authorized W&H Service Partners

    Authorized W&H service partners Find your nearest authorized W&H service partner at http://wh.com Simply go to the menu option “Service” for full details. Or simply scan the QR code.
  • Page 50 W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 50928 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 009 / 17.07.2023 office@wh.com wh.com Subject to alterations...

This manual is also suitable for:

Pl-40 h

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