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W&H Med piezomed pro M-PH350 Instructions For Use Manual

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Instructions for Use
M-PH350
M-PM100

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Summary of Contents for W&H Med piezomed pro M-PH350

  • Page 1 Instructions for Use M-PH350 M-PM100...

  • 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........................................17 6. Start-up ........................................21 7. Operation ........................................26 8. Icons ......................................... 28 9. Error messages ......................................31 10.
  • Page 3 Contents 14. Data on electromagnetic compatibility according to IEC/EN 60601-1-2..................53 15. Disposal ......................................... 56 W&H course certificate ....................................59 Explanation of warranty terms ................................... 60 Authorized W&H service partners ................................61...

  • Page 4: Symbols

    Symbols WARNING! Sterilizable up to Consult Instructions for Use (risk of injury) the stated temperature ATTENTION! Suitable for Do not dispose of with (to prevent damage occurring) ultrasonic bath domestic waste General explanations, without CE marking with identification Catalogue number risk to persons or objects number of the Notified Body XXXX...
  • Page 5 Symbols Follow Instructions for Use Power (watt) Type B applied part (not suitable for intracardiac application) Batch code DC – direct current Not for re-use Foot control This way up “Der Grüne Punkt” (The Green Dot) trademark of Duales System Deutschland GmbH Electric voltage (volt) Fragile, handle with care...
  • Page 6 Symbols MEDICAL – GENERAL MEDICAL Caution! Federal law restricts DataMatrix Code for product EQUIPMENT AS TO ELECTRICAL this device to sale by or on the information including UDI 25UX SHOCK, FIRE AND MECHANICAL order of a physician, dentist, (Unique Device Identification) HAZARDS ONLY IN ACCORDANCE veterinarian or with the WITH ANSI/AAMI ES60601-...

  • 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 Observe the safety notes.
  • Page 8 Introduction 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: > The medical device must be used in accordance with these Instructions for Use. >...

  • Page 9: Unpacking

    2. Unpacking Control unit M-PM100  Remove the carton.  Remove the packaging and remove the power supply, irrigation tubing set and accessories.  Lift out the Instructions for Use, control unit and mains cable. 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 M-PM100 Control unit 30500000 Mains cable country-specific Optional included in set REF 30501000 Handpiece M-PH350 with 3,5 m cable REF 00636901 Nozzle cleaner REF 30264000 Foot control S-NW REF 30285000 Foot control S-N2 REF 08132760 Instrument changer M-IC350 REF 07883900 Power supply REF 08174800...

  • Page 11: Safety Notes

    4. 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 12 Safety notes Power failure In the event of a power failure or if the control unit is switched off, the last values set are saved and re-activated on power- System failure A total system failure does not constitute a critical fault. Mains cable/Power supply >...
  • Page 13 Safety notes Control unit 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 Safety notes Coolant supply The medical device is designed for use with physiological saline solution. > Always ensure the correct operating conditions and cooling function. > Use only suitable coolants and follow the manufacturer’s medical data and instructions. > In case of coolant supply failure, the medical device must be stopped immediately. >...
  • Page 15 Safety notes Intermittent periodic duty S3 (60 s ON / 30 s OFF) The medical device is designed for intermittent periodic duty S3 with 60 seconds ON and 30 seconds OFF. If the specified operating mode is observed no overheating of the system and therefore no injury to the patients, users or third parties arises.
  • Page 16 Safety notes Hygiene and maintenance prior to initial use > Clean the control unit. > Clean and disinfect the handpiece with cable, the universal support, the instruments, the instrument changer and the stand. > Sterilize the the handpiece with cable, the universal support, the instruments and the instrument changer. Test run Do not hold the handpiece with cable at eye level! >...

  • Page 17: Description

    5. Description Control unit M-PM100 Stand holder Connection for power supply Connection cable Connection for handpiece Connection for foot control...
  • Page 18 Description Handpiece with cable M-PH350 Nozzle cleaner Coolant tube Thread Handpiece cap...
  • Page 19 Description Foot control S-N2 / S-NW Locator ORANGE attach/detach GREEN YELLOW GREY Start motor (pedal) ON/OFF...
  • Page 20 Description of foot control S-N2 / S-NW ORANGE S-NW: Switching between multiple control units Press the ORANGE button for 3 seconds. S-NW: Change application Press the ORANGE button for 3 seconds until an acoustic signal sounds. S-N2: Change application Press the ORANGE button for 3 seconds until an acoustic signal sounds. GREEN Press the green button to change the coolant volume in steps of 20% Press and hold the GREEN button to activate the coolant filling function.

  • Page 21: Start-Up

    6. Start-up Place the medical device on a flat level surface. Ensure that the medical device can be disconnected from the power supply at any time.  Attach the control unit until it  Connect handpiece cable. engages. Pay attention to the positioning! ...
  • Page 22 Start-up  Attach the universal support and lock it.  Insert the irrigation tubing. > Open the pump cover (a, b). > Insert the irrigation tubing (c). > Close the pump cover (d).
  • Page 23 Start-up Insert/remove instruments  Screw the instrument onto  Attach the instrument the thread of the handpiece changer to the instrument. by hand. Attach the instrument changer to the instrument.  Turn the instrument changer  Unscrew the instrument with until it snaps into place.
  • Page 24 Start-up Control unit switching on and off  Plug the mains cable/power  Pull the power plug out of the supply into an earthed power socket. socket.  Switch on/off the control unit at the power switch. Ensure that the M-PM100 is connected to the power supply before switching on the control unit at the power switch.
  • Page 25 Start-up Coolant filling function operation Make sure that the coolant filling function has been carried out prior to every application. Coolant filling function Start the coolant filling function by confirming the entry. The coolant filling functions lasts for 15 seconds. Press any button on the display or the foot control to stop the coolant filling function.

  • Page 26: Operation

    7. Operation Main menu     Application area   Setup  Coolant filling function  Foot control  Coolant volume    Power...
  • Page 27 Operation Navigation * Only visible when using the foot control S-NW. ** Visible in Piezo mode / *** visible in Amadeo mode...

  • Page 28: Icons

    8. Icons User System An activated user cannot be deleted Amadeo mode > Switch from Piezo mode to Amadeo mode Add user Piezo mode > Switch from Amadeo mode to Piezo mode Manage user User settings: Copy, Rename, Activate, Delete Coolant filling function Confirm/save Screen lock...
  • Page 29 Icons Language Import user settings > Select Export user settings Device info Service Change application > Activating/deactivating Switch only between Licenes Amadeo/Piezo mode GPL: GNU General Public License LGPL: GNU Lesser General Public License Change application OFF Module info Reset Pump run no-scaler >...
  • Page 30 Icons red = replace batteries Setting selected black = Information Foot control S-NW green = Information with selection option Foot control S-N2 red = error message, work cannot be continued orange = error message, work can be continued Reduce/increase parameters >...

  • Page 31: Error Messages

    9. Error messages Icon Description of error Solution WARNING FOOT CONTROL > Check plug-in connection of foot control > Check the plug-in connection of the dongle WARNING SWITCH COOLANT SUPPLY > Ensure the coolant supply for the selected applied part >...

  • Page 32: Hygiene And Maintenance

    10. Hygiene and maintenance General notes Follow your local and national laws, directives, standards and guidelines for cleaning, disinfection and sterilization. The instruments can be reprocessed in the instrument stand (REF 08174900). > Wear protective clothing, safety glasses, face mask and gloves. >...

  • Page 33: 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 34: Initial Treatment At The Point Of Use

    Hygiene and maintenance Initial treatment at the point of use > Clean the control unit immediately after every treatment. > Clean the handpiece with cable immediately after every treatment, to flush out liquid (e.g., blood, saliva etc.) and to prevent settling on the internal parts. >...

  • Page 35: Manual Cleaning

    Hygiene and maintenance Manual cleaning Disassembling the handpiece with cable  Unscrew the handpiece cap. Handpiece with cable, instruments, instrument changer, universal support, stand Do not place the handpiece with cable, the instrument changer, the universal support and the stand in liquid disinfectant or in an ultrasonic bath.
  • Page 36 Hygiene and maintenance Manual cleaning Instruments Clean and disinfect diamond coated instruments in an ultrasonic bath. Evidence of the medical device’s basic suitability for effective manual cleaning and disinfection was provided by an independent test laboratory using the “Bandelin Type RK 100CC” ultrasonic bath and the cleaning agent and disinfectant “StammopurDR8”...
  • Page 37 Hygiene and maintenance Manual cleaning Control unit Do not immerse the control unit in water or clean it under running water. Evidence of the medical device’s basic suitability for effective manual cleaning was provided by an independent test laboratory using tap water < 35°C and towels/cloth »WIPEX ® WET DESI premium« (NORDVLIES GmbH, Bargteheide).

  • Page 38: Manual Disinfection

    Hygiene and maintenance Manual disinfection Control unit, universal support, stand, handpiece with cable, instruments, instrument changer W&H recommends wiping down with disinfectant. Evidence of the basic suitability of the control unit, the universal support, the stand, the handpiece with calbe, the instruments and the instrument changer for effective manual disinfection was provided by an independent test laboratory using the disinfectants “mikrozid®...

  • Page 39: Automated Cleaning And Disinfection

    Hygiene and maintenance Automated cleaning and disinfection Universal support, stand, handpiece with cable, instruments, instrument changer 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 and washer disinfector adaptors.

  • Page 40: Drying

    Hygiene and maintenance Drying Universal support, stand, handpiece with cable, instruments, instrument changer > Ensure that the universal support,the stand, the handpiece with cable, the instruments and the instrument changer are completely dry after cleaning and disinfection. > Remove liquid residues using compressed air.

  • Page 41: Inspection, Maintenance And Testing

    Hygiene and maintenance Inspection, maintenance and testing Universal support, stand, handpiece with cable, instruments, instrument changer > Check the universal support, the stand, the handpiece with cable, the instruments and the instrument changer after cleaning and disinfection for damage, visible residual soiling and surface changes. >...

  • Page 42: Packaging

    Hygiene and maintenance Packaging Universal support, handpiece with cable, instruments, instrument changer Pack the universal support, the handpiece with cable, the instruments and the instrument changer in sterilization packages that meet the following requirements: > The sterilization procedure must meet the applicable standards in respect of quality and use and must be suitable for the sterilization method.
  • Page 43 Hygiene and maintenance Sterilization Universal support, handpiece with cable, instruments, instrument changer 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. >...

  • Page 44: Sterilization

    Hygiene and maintenance Sterilization Evidence of the basic suitability of the universal support, the handpiece with cable, the instruments and the instrument changer for effective sterilization was provided by an independent test laboratory using the LISA 517 B17L* steam sterilizer (W&H Sterilization S.r.l., Brusaporto (BG)), the Systec VE-150* steam sterilizer (Systec) and the CertoClav MultiControl MC2-S09S273** steam sterilizer (CertoClav GmbH, Traun).

  • Page 45: Storage

    Hygiene and maintenance Storage Universal support, handpiece with cable, instruments, instrument changer > Store sterile goods dust-free and dry. > The shelf life of the sterile goods depends on the storage conditions and type of packaging.

  • Page 46: Service

    11. Service 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 47 Service 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 48: 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 (Link: https://www.wh.com) 08132760 08174900 07721800 08067690 Instrument changer Instrument stand Universal support Stand M-IC350 08046870...
  • Page 49 Accessories, consumables, spare parts and other recommended medical devices by W&H 08174820 Piezomed Pro cassette Scan the QR code to find accessories, consumables and spare parts for this medical device.

  • Page 50: Technical Data

    13. Technical data Control unit M-PM100 Control unit M-PM100 Supply voltage: 100 – 240 V Operating voltage: 30 – 32 V DC Frequency: 50 – 60 Hz Maximum power output (ultrasonic): 24 W Operating frequency: 22 – 35 kHz Coolant flow rate at 100 %: at least 90 ml/min Operating mode: S3 (60 s ON / 30 s OFF)
  • Page 51 Technical data Handpiece with cable M-PH350 Handpiece with cable M-PH350 Maximum power consumption: 24 W Frequency (ultrasonic) 22 –35 kHz Coolant flow rate at 100 %: at least 90 ml/min Operating mode: S3 (60 s ON / 30 s OFF) Type B applied part (not suitable for intracardiac application) Temperature information Temperature of the medical device on the operator side:...
  • Page 52 Technical data Ambient conditions Temperature during storage and transport: -40°C to +70°C (-40°F to +158°F) Humidity during storage and transport: 8% to 80% (relative), non-condensing Temperature during operation: +10°C to +30°C (+50°F to +86°F) Humidity during operation: 15% to 80% (relative), non-condensing Pollution level: Overvoltage category: Altitude:...

  • Page 53: 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 54 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 55 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 56: 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 57 W&H course certificate for the instructor The user has been trained to use the medical device correctly in accordance with the legal regulations (medical devices marketing regulations, medical devices act). Particular attention has been paid to the chapters on safety notes, start-up, operation, hygiene and maintenance, and service (regular inspections). Product name Serial number (SN) Manufacturer with address...

  • Page 59: W&H Course Certificate

    W&H course certificate for the user The user has been trained to use the medical device correctly in accordance with the legal regulations (medical devices marketing regulations, medical devices act). Particular attention has been paid to the chapters on safety notes, start-up, operation, hygiene and maintenance, and service (regular inspections). Product name Serial number (SN) Manufacturer with address...

  • Page 60: 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 61: 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 62 Software version: 01.00.00 W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 51076 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 002 / 02.09.2024 office@wh.com wh.com Subject to alterations...

This manual is also suitable for:

Piezomed pro m-pm100

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