W&H Proxeo Ultra PB-510 Instructions For Use Manual
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W&H Proxeo Ultra PB-510 Instructions For Use Manual

W&H Proxeo Ultra PB-510 Instructions For Use Manual

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Instructions for Use
PB-510, PB-520, PB-530

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Summary of Contents for W&H Proxeo Ultra PB-510

  • Page 1 Instructions for Use PB-510, PB-520, PB-530...

  • Page 2: Table Of Contents

    Contents Symbols .......................................... 4 1. Introduction ....................................... 8 2. Electromagnetic compatibility (EMC) ..............................10 3. Unpacking ........................................ 11 4. Scope of delivery ......................................12 5. Safety notes ......................................13 6. Description....................................... 18 Control unit PB-510 ..................................... 18 Control unit PB-520..................................... 19 Control unit PB-530 .................................... 20 Foot control C-NF/C-NW ..................................21 Status LED foot control C-NW ................................
  • Page 3 Contents 11. Maintenance ......................................36 Replacing the O-ring of the coolant tank ............................36 Replacing the coolant filter of the coolant hose ..........................36 Replacing the pump cartridge ................................37 12. Servicing ........................................ 38 13. W&H accessories and spare parts ............................... 40 14.

  • Page 4: Symbols

    Symbols in the Instructions for Use WARNING! ATTENTION! General explanations, (risk of injury) (to prevent damage occurring) without risk to persons or objects...
  • Page 5 Symbols on the medical device Consult Instructions for Use CE mark Supply voltage with identification number XXXX of the Notified Body Follow Instructions for Use Foot control Electric power consumption Frequency of the Date of manufacture Non-ionizing electromagnetic alternating current radiation Do not dispose of with Catalogue number...
  • 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 DataMatrix Code Protection against Date of manufacture IPX1 for product information dripping water...
  • Page 7 Symbols on the packaging CE mark with identification number DataMatrix Code 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 8: 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 9 Introduction Production according to EU Directive The medical device meets the requirements of Directive 93/42/EEC. The foot control meets the requirements of Directive 93/42/EEC and RED Directive 2014/53/EU. 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 10: 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 11: Unpacking

    3. Unpacking  Remove the insert.  Remove the Instructions for Use and the accessories.  Remove the control unit, the coolant tank and the foot control. W&H packaging is environmentally friendly and can be disposed of by industrial recycling companies. However, we recommend that you keep the original packaging.

  • Page 12: Scope Of Delivery

    4. Scope of delivery Control unit (100–230 V) PB-510 PB-520 PB-530 30323000 30324000 30325000 REF 02675000 Coolant filter REF 05075600 Coolant hose (Ø 6 mm, approx. 2 m) REF 08016690 Power supply with adaptor REF 07991190 Coolant tank REF 08014700 Cable (pairing/charging) Optional REF 30316000 Foot control C-NW REF 04717300...

  • Page 13: Safety Notes

    5. Safety notes Control unit/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. > Do not operate the medical device if it is damaged. >...
  • Page 14 Safety notes Control unit/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 explosive atmospheres. Disconnect the medical device in dangerous situations from the power supply. >...
  • Page 15 Safety notes Control unit Control unit PB-510 > Disconnect the medical device from the water supply connection after each use (the medical device does not have an automatic aquastop). > The medical device is approved for use only with supply units with category 5 backflow prevention devices as defined in EN 1717.
  • Page 16 Safety notes Foot control > Keep the foot control (C-NW) away from magnetic fields. > Replace the foot control as soon as the resistance is noticeably reduced. > Do not expose the medical device to any violent mechanical impacts. Battery (C-NW) >...
  • Page 17 Safety notes Foot control C-NW Foot control C-NW Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillators (ICD) can be affected by electric, magnetic and electromagnetic fields. This medical device complies with the reference values defined in EN 50527-2-1/2016 for unipolar and bipolar pacemakers and is therefore suitable for patients with pacemakers.

  • Page 18: Description

    6. Description Control unit PB-510             Connections Status LED Power range   Power supply  Cover Power regulator   ESI (external service interface)   » « Foot control ...

  • Page 19: Control Unit Pb-520

    Description Control unit PB-520              Status LED Power range Coolant tank    Filling level indicator Coolant regulator Power regulator    Connections Cover  » «...

  • Page 20: Control Unit Pb-530

    Description Control unit PB-530              LED display Connections   Power regulator  Coolant tank > Power range Power supply   » «  Filling level indicator >...

  • Page 21: Foot Control C-Nf/C-Nw

    Description Foot control C-NF/C-NW C-NW C-NF      Charging LED (orange) Status LED (green)  Connection for cable (pairing/charging)  Cable (pairing/charging) ...

  • Page 22: Status Led Foot Control C-Nw

    Description Status LED foot control C-NW Standby mode > The foot control can be activated by pressing. steady steady flashes flashes intermittently* GREEN e Connection to paired e Foot control is e Battery is flat medical device attempting to establish >...

  • Page 23: Start-Up

    7. Start-up Control unit general Ensure that the medical device can be disconnected from the power supply at any time. Place the medical device on a flat, level surface. Control unit PB-510 Mount the coolant filter  Cut through the coolant hose. ...
  • Page 24 Start-up Control unit general Control unit PB-520, PB-530 Coolant tank  Fill the coolant tank and attach it. The coolant tank snaps audibly into place. Control unit PB-510, PB-520, PB-530  Slide the adapter onto the power supply.  Connect the power supply. ...

  • Page 25: Control Unit Pb-530

    Start-up Control unit PB-530 Control unit PB-530 Power regulator »OFF« > 1. LED display flashes white Next steps: > Pairing foot control C-NW with control unit PB-530 > Charging the battery of the foot control C-NW with control unit PB-530 Coolant and handpiece inactive The foot control C-NW and control unit PB-530 are not paired when delivered! Pairing foot control C-NW with control unit PB-530...
  • Page 26 Start-up Control unit PB-530 Charge the foot control fully before you use it for the first time. Charging foot control C-NW with control unit PB-530 Battery status  Connect the cable to the control unit and foot control > Power regulator »OFF«: The charging level is visible for 5 seconds at the LED display.
  • Page 27 Start-up Control unit PB-530 Control unit and foot control are not connected with the cable. Indication: battery of foot control is flat e Power setting: e Power setting 0: 1. LED flashes green, 1. LED flashes white/blue remaining LEDs are flashing green >...

  • Page 28: Functions Control Units

    Start-up Functions control units > Before every patient: Perform rinsing funcion for automatic internal cleaning of the coolant channels. > W&H recommends performing the cleaning function once a month using the active substance chlorhexidine 0.2%. Fill coolant tank with at least 200 ml cleaning liquid. Then perform a rinsing function with tap water. Proxeo Ultra PB-510 PB-520...

  • Page 29: Operation Control Unit

    8. Operation control unit Rinsing function Control unit PB-510, PB-520  Remove the handpiece from the supply  Set power to 0  Press foot control 3 times within 3 seconds > Rinsing function active for 30 seconds Cancelling the rinsing function with one of these options: >...

  • Page 30: Cleaning Function

    Operation control unit Cleaning function Control unit PB-530  Remove the handpiece from the supply hose  Set power  Press funtion button 3 seconds > Cleaning function active for 8 minutes, visible by blue LEDs > Pump stops several times during the cleaning function >...

  • Page 31: Start-Up

    Operation control unit Start-up Control unit PB-510, PB-520, PB-530  Attach the handpiece to the supply hose. Insert tip. Follow the directions and safety notes in the Instructions for Use of the W&H handpieces.  Set power and coolant (variable)  Press foot control >...
  • Page 32 Test run Do not hold the handpiece at eye level! > Attach the handpiece to the supply hose. > Insert the tip. > Put the medical device into operation. In the event of operating malfunctions (e.g., vibrations, unusual noise, overheating, coolant failure or leakage) stop the medical device immediately and contact an authorized W&H service partner.

  • Page 33: Error Messages

    9. Error messages Control unit PB-510, PB-520 The error messages are indicated at the rear of the control unit by the status LED (flashing green). Flashing cycle Description of error Solution Overheating > Switch off conrol unit > Allow the control unit to cool for at least 10 minutes >...
  • Page 34 Error messages Control unit PB-530 The error messages are indicated by the LED display (LED steady). LED display Colour Description of error Solution 1. LED orange Overheating > Switch off control unit > Allow the control unit to cool for at least 10 minutes >...

  • Page 35: Hygiene And Maintenance

    10. 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. > Wipe the entire medical device and the foot control with disinfectant. >...

  • Page 36: Maintenance

    11. Maintenance Proxeo Ultra PB-510 PB-520 PB-530 Replacing the O-ring of the coolant tank – ✔ ✔ Replacing the coolant filter of the coolant hose – – ✔ Replacing the pump cartridge – ✔ ✔ Replacing the O-ring of the coolant tank ...

  • Page 37: Replacing The Pump Cartridge

    Maintenance Replacing the pump cartridge  Uncrew cover and remove.  Attach new pump cartridge. Snaps audibly into place.  Pull off coolant hoses.  Attach the coolant hoses until the limit stop.  Unlock pump cartridge and  Attach cover and screw tight. pull it out.

  • Page 38: Servicing

    12. Servicing Regular checks Regular servicing of function and safety including the accessories is necessary and should be carried out at least once every three years, unless shorter intervals are prescribed by law. The inspection must be undertaken by a qualified organisation and must include the following procedures: Control unit >...
  • Page 39 Servicing Repair 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. > Always return equipment in the original packaging!

  • Page 40: W&H Accessories And Spare Parts

    13. W&H accessories and spare parts Use only original W&H accessories and spare parts or accessories approved by W&H. Suppliers: W&H partners 30326000 02675000 07991190 07960870 Handpiece PB-5 L Coolant filter Coolant tank O-ring for coolant tank 30327000 05075600 Handpiece PB-5 L Q Coolant hose 30328000 Handpiece PB-5 L S...
  • Page 41 W&H accessories and spare parts 04717300 30316000 Foot control C-NF Foot control C-NW with Stick...

  • Page 42: Technical Data

    14. Technical data Control unit PB-510 PB-520 PB-530 Power supply: 28.3–31.5 V Mains voltage: 100–230 V Nominal current: max. 830 mA Permissible voltage fluctuation: ±10% Max. output power to the handpiece 12 W under load (ultrasonic): Frequency (ultrasonic): 22–35 kHz Operating mode: S3 (14sec/6sec) Max.
  • 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 Nominal voltage: 3.7 V Nominal capacity: 680 mAh Dimensions (WxDxH): 117 x 117 x 38 mm Weight: 190 g Ambient conditions Temperature during storage and transport: -20°C to +60°C (-4°F to +140°F)
  • 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 The C-NF/C-NW foot control is protected against vertically falling drops of water (IPX1 as per IEC 60529) Pollution level: Overvoltage category: Altitude:...

  • Page 45: Disposal

    15. 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: Authorised W&H Service Partners

    Authorised W&H service partners Find your nearest W&H service partner at http://wh.com Simply go to the menu option »Service« for full details. Alternatively please contact: W&H (UK) LIMIT, 6 Stroud Wood Business Centre, Park Street, St Albans, Hertfordshire AL2 2NJ, United Kingdom t +44 1727 874990, f + 44 1727 872254, E-Mail: technical.uk@wh W&H Impex Inc., 6490 Hawthorne Drive, Windsor, Ontario, N8T 1J9, Canada t +1 800 2656277, 1 519 9446739, f + 1 519 9746121, E-Mail: service.ca@wh.com...

  • 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. 50968 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 001 / 15.04.2019 office@wh.com wh.com Subject to alterations...

This manual is also suitable for:

Proxeo ultra pb-530Proxeo ultra pb-520

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