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 ....................................... 7 2. Unpacking ........................................9 3. Scope of delivery ..................................... 10 4. Safety notes ......................................11 5. Description....................................... 16 Control unit PB-510 ..................................... 16 Control unit PB-520....................................17 Control unit PB-530 .................................... 18 Foot control C-NF/C-NW ..................................19 Status LED foot control C-NW ................................
  • Page 3 Contents Inspection, maintenance and testing ............................... 38 Waterline disinfection treatment ..............................39 10. Maintenance ......................................40 Replacing the O-ring of the coolant tank ............................40 Replacing the coolant filter of the coolant hose ..........................40 Replacing the pump cartridge ................................41 11.

  • Page 4: Symbols

    Symbols WARNING! CE marking with identification Foot control (risk of injury) number of the Notified Body XXXX ATTENTION! Medical Device Non-ionizing electromagnetic (to prevent damage occurring) radiation General explanations, without Thermo washer disinfectable Catalogue number risk to persons or objects Follow Instructions for Use Sterilizable up to the stated Serial number...
  • Page 5 Symbols Electric voltage (volt) On / Off Temperature limitation +60 °C (+140°F) Max. -20 °C (-4°F) Min. Power (watt) Coolant volume Humidity limitation 80 % Frequency (hertz) Upper limit of temperature DataMatrix Code +30°C Max. (+86°F) for product information including UDI (Unique Device Identification) Reset This way up...
  • Page 6 Symbols Trademark of RESY OfW GmbH MEDICAL – GENERAL MEDICAL for identification of recyclable EQUIPMENT AS TO ELECTRICAL transport and outer packaging 25UX SHOCK, FIRE AND MECHANICAL of paper and cardboard HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 60601-1:2005, ANSI/AAMI ES60601-1: A1:2012 Caution! Federal law restricts + C1:2009/(R)2012 + A2:2010/ this device to sale by or on the...

  • 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.
  • Page 8 Introduction Hereby, W&H declares that the medical product 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: Unpacking

    2. 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 10: Scope Of Delivery

    3. Scope of delivery Control unit (100–240 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 11: Safety Notes

    4. 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 12 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. > The medical device is not approved for operation in oxygen rich environment. Disconnect the medical device in dangerous situations from the power supply.
  • Page 13 Safety notes Control unit/Foot control Risks due to electromagnetic fields The functionality of active implantable medical devices (AIMD) (e.g. cardiac pacemaker, ICD) can be affected by electric, magnetic and electromagnetic fields. > Find out if the patient has active implantable medical devices (AIMD) before using the medical device and inform about the risks.

  • Page 14: Control Unit

    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 15: Foot Control

    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 16: Description

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

  • Page 17: 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 18: Control Unit Pb-530

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

  • Page 19: 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 20: Status Led Foot Control C-Nw

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

  • Page 21: Start-Up

    6. 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 22 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 adaptor onto the power supply.  Connect the power supply. ...

  • Page 23: Control Unit Pb-530

    Start-up Control unit PB-530 Control unit PB-530 Power regulator “OFF” > 1. LED 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  Set power regulator to “OFF”...
  • Page 24 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 25 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 lit up in green >...

  • Page 26: Functions Control Units

    Start-up Functions control units Proxeo Ultra PB-510 PB-520 PB-530 Rinsing function for automatic internal cleaning of the coolant channels ✔ ✔ ✔ Cleaning function for automatic internal cleaning of the coolant channels – – ✔ Before every patient: Perform rinsing function for automatic internal cleaning of the coolant channels. Approved coolants and rinsing liquids >...

  • Page 27: Operation Control Unit

    7. Operation control unit Rinsing function Control unit PB-510, PB-520  Remove the handpiece from the supply hose  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 28: Cleaning Function

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

  • Page 29: 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 30 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 31: Error Messages

    8. 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 32 Error messages Control unit PB-530 The error messages are indicated by the LED display (LED illuminated). 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 33: Hygiene And Maintenance

    9. 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 for manual drying. >...

  • Page 34: 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 35: 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 medical device with disinfectant. > The charger (C-NW) must not be connected. > Ensure that no fluids enter the medical device. Note that the disinfectant used during pre-treatment is only for personal protection and cannot replace the disinfection step after cleaning.

  • Page 36: Manual Cleaning

    Hygiene and maintenance Manual cleaning > Do not place the medical device in liquid disinfectant or in an ultrasonic bath. > Do not immerse the medical device in water or clean it under running water. Coolant tank > Clean the coolant tank under running tap water (< 35°C / < 95°F). >...

  • Page 37: Manual Disinfection

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

  • Page 38: 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 39: Waterline Disinfection Treatment

    Hygiene and maintenance Waterline disinfection treatment W&H recommends performing the rinsing function (PB-520) or the cleaning function (PB-530) using an approved cleaning agent according to the manufacturer's instruction. Fill coolant tank with at least 200 ml of liquid. Approved cleaning agents >...

  • Page 40: Maintenance

    10. 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 41: Replacing The Pump Cartridge

    Maintenance Replacing the pump cartridge  Unscrew 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 42: Servicing

    11. 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 43 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 44: Accessories, Consumables, Spare Parts And Other Recommended Medical Devices By W&H

    12. 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. 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...
  • Page 45 Accessories, consumables, spare parts and other recommended medical devices by W&H Scan the QR code to find accessories, consumables and spare parts for this medical device. 04717300 30316000 Foot control C-NF Foot control C-NW with Stick...

  • Page 46: Technical Data

    13. Technical data Control unit PB-510 PB-520 PB-530 Power supply: 28.5–31.5 V Mains voltage: 100–240 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 47 Technical data Foot control C-NW C-NF 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 102 x 106.5 x 26.5 mm Weight: 190 g...
  • Page 48 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!) The C-NF/C-NW foot control is protected against vertically falling drops of water (IPX1 as per IEC 60529) Type B applied part (not suitable for intracardiac application) Pollution level: Overvoltage category:...

  • Page 49: Data On Electromagnetic Compatibility According To Iec/En 60601-1-2

    14. 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 50 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 51 Results of the electromagnetic tests Requirement Class / Test Level* Electromagnetic emissions Mains terminal disturbance voltage (Conducted Emissions) Group 1 CISPR 11/EN 55011 Class B [150 kHz – 30 MHz] Electromagnetic radiation disturbance (Radiated Emissions) Group 1 CISPR 11/EN 55011 Class B [30 MHz –...
  • Page 52 Results of the electromagnetic tests Proximity fields from RF wireless communications equipment 385 MHz 27 V/m IEC/EN 60601-1-2 Table 9 450 MHz 28 V/m IEC/EN 61000-4-3 710 / 745 / 780 MHz 9 V/m 810 / 870 / 930 MHz 28 V/m 1720 / 1845 / 1970 MHz 28 V/m...

  • Page 53: 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 54: 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 55: 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 56 Software version PB-510, PB-520: 01.01.00 Software version PB-530: User interface: 01.03.00 PC-1.0: 01.01.00 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. 004 / 21.10.2024 office@wh.com wh.com Subject to alterations...

This manual is also suitable for:

Proxeo ultra pb-520Proxeo ultra pb-530

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