W&H proxeo TWIST PL-40 HW Instructions For Use Manual
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W&H proxeo TWIST PL-40 HW Instructions For Use Manual

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Instructions for use
PL-40 HW

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Summary of Contents for W&H proxeo TWIST PL-40 HW

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

  • Page 2: Table Of Contents

    Contents 1. Introduction ....................................... 9 2. Electromagnetic compatibility (EMC) ..............................11 3. Scope of delivery ......................................12 4. Safety notes ......................................13 5. Description....................................... 18 Handpiece drive ....................................18 Foot control ......................................19 Status LED handpiece drive ................................20 Status LED foot control ..................................21 6.
  • Page 3 Contents 9. Replacing the O-ring ....................................37 10. Servicing ........................................ 38 11. W&H Accessories and spare parts ............................... 40 12. Technical data ......................................42 13. Disposal........................................45 Explanation of warranty terms ................................... 46 Authorized W&H service partners ................................47 Manufacturer’s declaration..................................48...
  • Page 4 Symbols in the instructions for use WARNING! ATTENTION! General explanations, (risk of injury) (to prevent damage occurring) without risk to persons or objects Not for re-use Sterilizable up to Thermo washer disinfectable the stated temperature Class II medical electrical equipment...
  • Page 5 Symbole on the handpiece drive Follow instructions for use Data Matrix code Catalogue number for product information including UDI (Unique Device Identification) Date of manufacture Serial number CE mark with identification number Do not dispose of with DC – direct current XXXX of the Notified Body domestic waste...
  • Page 6 Symbols on the foot control CE mark Non-ionizing electromagnetic Catalogue number with identification number radiation XXXX of the Notified Body Do not dispose of with DC – direct current Serial number domestic waste Data Matrix code Protection against Date of manufacture IPX1 for product information dripping water...
  • Page 7 Symbols radio symbol on the medical device / foot control ANATEL – Brazil 209 - J00204 GITEKI (MIC) – Japan FCC / IC – USA / Canada RCM – Australian / New Zealand...
  • Page 8 Symbols on the packaging CE mark with identification Data Matrix code number of the Notified Body for product information including UDI XXXX (Unique Device Identification) This way up Data structure in accordance with Health Industry Bar Code Fragile, handle with care Temperature limitation +60 °C (+140°F) Max.

  • Page 9: 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 10 Introduction Hereby, W&H declares that the foot control 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 11: Electromagnetic Compatibility (Emc)

    2. Electromagnetic compatibility (EMC) Medical electrical equipment is subject to particular precautions in regard to EMC and must be installed and put into operation in accordance with the EMC notes included. W&H guarantees the compliance of the device with the EMC requirements only when used with original W&H accessories and spare parts.

  • Page 12: Scope Of Delivery

    3. Scope of delivery Description 30410000 Handpiece drive 30316000 Foot control C-NW with Stick 07969610 Charger with adaptor 05882600 Handpiece holder...

  • Page 13: Safety Notes

    4. Safety notes Handpiece drive / Foot control > 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. >...
  • Page 14 Safety notes Handpiece drive / Foot control 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 15 Safety notes Handpiece drive / Foot control Handpiece drive Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillator (ICD) can be affected by electric, magnetic and electromagnetic fields. This medical device is suitable for use on patients with unipolar and bipolar pacemakers or ICD, if a safety distance between the medical device and the cardiac pacemaker or ICD of at least 7 cm (2,76 inch) is maintained.
  • Page 16 Safety notes Handpiece drive / Foot control 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 17 Safety notes Handpiece-/contra-angle head > Use only the handpiece drive with the handpiece-/contra-angle head PL-44, PL-66 W, PL-64. > Follow the directions and safety notes in the Instructions for Use of the handpiece-/contra-angle head.

  • Page 18: Description

    5. Description Handpiece drive W&H coupling for handpiece-/contra-angle head Status LED handpiece drive (see page 20) Status LED foot control (see page 21) Charging socket ON/OFF button...

  • Page 19: Foot Control

    Description Foot control Stick Charging LED (orange) Status LED (green) (see page 21 – 22) (see page 21, 24) Charging socket Reset button Pairing button...

  • Page 20: 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 21: 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 24) Standby mode >...

  • Page 22: Start-Up

    6. 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 23: 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 24: 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 25 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 26: Assembly/Removal Of The Handpiece-/Contra-Angle Head

    Start-up Assembly/removal of the handpiece-/contra-angle head Do not assemble or remove the handpiece-/contra-angle head during operation!   Push the handpiece-/contra-angle head onto the handpiece drive.  Verify full engagement.    Remove the handpiece-/contra-angle head.

  • Page 27: Handpiece Drive

    7. Handpiece drive Operation Switch on  Press the foot control to  Press the ON/OFF button. 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 28 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 29: Hygiene And Maintenance

    8. 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. 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 30: 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 31: 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 holder and the foot control with disinfectant. > Ensure that no fluids enter the medical device. >...

  • Page 32: Manual Cleaning

    Hygiene and maintenance Manual cleaning > Do not place the handpiece drive, the handpiece holder and the foot control in liquid disinfectant or in an ultrasonic bath. > Do not immerse the handpiece drive and the foot control in water or clean them under running water. Handpiece holder >...

  • Page 33: Manual Disinfection

    Hygiene and maintenance Manual disinfection > W&H recommends wiping down with disinfectant. Evidence of the basic suitability of the handpiece drive and the handpiece holder for effective manual disinfection was provided by an independent test laboratory using the “mikrozid® AF wipes” disinfectant (Schülke & Mayr GmbH, Norderstedt) and “CaviWipes™”...

  • Page 34: Automated Cleaning And Disinfection

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

  • Page 35: 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 36: 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 37: Replacing The O-Ring

    9. 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 38: Servicing

    10. 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: W&H Accessories And Spare Parts

    11. W&H Accessories and spare parts Use only original W&H accessories and spare parts or accessories approved by W&H. Supplier: W&H partners 07947190 05882600 01225100 07969610 Handpiece drive Handpiece holder O-ring Charger incl. adaptor 30316000 30096000 30097000 30098000 Foot control C-NW PL-66 W Contra-angle head PL-64 Contra-angle head PL-44 Handpiece head...
  • Page 41 W&H Accessories and spare parts 07597900 08003630 08003650 07979710 Prophy Cups, firm / dark green, Prophy Cups, soft / apple green, Prophy Brushes, cup-shaped, Prophy Angle Cup, 105°, LatchShort (144 pcs) LatchShort (144 pcs) soft / clear, LatchShort (144 pcs) firm / dark green (100 pcs) 07994950 Prophy Angle Cup, 105°,...

  • Page 42: Technical Data

    12. 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 PL-40 HW Battery type:...
  • Page 43 Technical data Foot control C-NW Battery type: Li-ion Runtime: approx. 2 months Standby: automatically if not actuated Charging time: approx. 3 h Rated voltage: 3.7 V Rated capacity: 680 mAh Dimensions (WxDxH): 117 x 117 x 38 mm Weight: 190 g Charger Rated voltage: 100 - 240 V...
  • Page 44 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) The C-NW foot control is protected against vertically falling drops of water (IPX1 as per IEC 60529) Pollution level:...

  • Page 45: 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 46: 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 47: 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 48: Manufacturer's Declaration

    Manufacturer’s declaration...
  • Page 49 Manufacturer’s declaration...
  • Page 50 Manufacturer’s declaration...
  • Page 51 Manufacturer’s declaration...
  • Page 52 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 51037 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 001 / 07.07.2021 office@wh.com wh.com Subject to alterations...

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