mectron Piezosurgery Plus Use And Maintenance Manual
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mectron Piezosurgery Plus Use And Maintenance Manual

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  • Page 1 Use and maintenance manual...

  • Page 2: Table Of Contents

    CONTENTS INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 01 .1 Intended use of the PIEZOSURGERY plus .
  • Page 3 MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 DISPOSAL MODES AND PRECAUTIONS .

  • Page 4: Introduction

    Depending on their degree of seriousness, of the date of publication specified on the the safety precautions are classified as: last page . Mectron is committed to the continuous updating of our products, which WARNING (Identifies conditions may entail changes to components of the...

  • Page 5: Description Of The Device

    07 - TECHNICAL DATA; and tested settings of Piezosurgery/ 3 The device is not used in accordance Mectron original inserts . The correct use with the instructions and requirements of the settings is guaranteed only with described in this manual;...

  • Page 6: Safety Requirements

    SAFETY REQUIREMENTS CAUTION: The wiring systems in WARNING: MR-UNSAFE the room in which the device is installed The Piezosurgery Plus MUST NOT BE and used must comply with applicable USED in a Magnetic Resonance (MR) standards and relevant electrical safety environment .
  • Page 7 INTRODUCTION CAUTION: Contraindications. Do WARNING - Breakage and wear of not carry out this treatment on metal the inserts. The high-frequency vibrations or ceramic prosthetic artefacts . The and general wear and tear can, very ultrasonic vibrations could cause them to occasionally, lead to insert breakage . Do decement . not bend, change the shape or sharpen an insert in any way .

  • Page 8: Symbols

    01.5 SYMBOLS Serial number Lot number Product code CAUTION: read the instructions for use Operating instructions 70 °C Temperature limitation - transport and storage conditions -10 °C 90 % Humidity limitation - transport and storage conditions 10 % 1060 hPa Atmospheric pressure limitation - transport and storage conditions 500 hPa Compliance with the CE 93/42, CEE EN 60601-1 e EN 60601-1-2 .

  • Page 9: Identification Data

    (ref. 5). Each extension/insert cover is laser-engraved with the following: - the Mectron logo and “Single-use” symbol (ref. 6); - the batch number to which the extension/insert cover belongs (ref. 7); - the length of the extension/insert cover and the...

  • Page 10: Delivery

    DELIVERY 03.1 LIST OF THE STANDARD EQUIPMENT See inside cover The PIEZOSURGERY plus is provided with: ® A device body B 2 peristaltic pumps C 2 drip stands for supporting the saline bags D manual of use and maintenance and manual of cleaning and sterilization E electrical power supply cable F foot pedal with bracket, cord and connector G case...

  • Page 11: Installation And Configuration

    04.1 SAFETY REQUIREMENTS DURING INSTALLATION WARNING: When the peristaltic WARNING: MR-UNSAFE The Piezosurgery Plus MUST NOT BE pump cover is open, the foot pedal of the USED in a Magnetic Resonance (MR) PIEZOSURGERY plus must not be pressed .

  • Page 12: Device Installation

    04.2 DEVICE INSTALLATION Equipotential plug: there is an additional equipotential plug on the back of the device . The plug complies with DIN 42801 . Insert the equipotential cable connector (not supplied) onto the plug on the back of the device . The purpose of the additional equipotential connection is to reduce the difference in potential that may occur during operation between the device body...

  • Page 13: Switching The Device On

    INSTALLATION AND CONFIGURATION Insert the irrigation bag support rods into the holes provided; Install the two peristaltic pumps, gently pushing the head of the peristaltic pump towards the corresponding base (on the device) . Carefully rotate the pump head forwards and backwards to ensure the two parts coincide;...

  • Page 14: Language Selection

    04.4 LANGUAGE SELECTION CAUTION: The language can only be chosen if no handpieces are connected to the device . Switch the device on without any handpieces connected . After the initial control of the whole system, the following screen appears. The first time the device is switched on, English is the predefined language .

  • Page 15: Irrigation Kit Assembly

    INSTALLATION AND CONFIGURATION 04.5 IRRIGATION KIT ASSEMBLY Open the previously-sterilised handpiece packaging and the irrigation kit, removing the tube and fixing clips. Connect the end of the irrigation tube to the specific attachment on the handpiece. Fix the irrigation tube to the cord-handpiece using the clips supplied;...

  • Page 16: Connection Of The Handpieces To The Device

    04.6 CONNECTION OF THE HANDPIECES TO THE DEVICE Channel 1 enables the PIEZOSURGERY ® medical handpiece to be used, to which the sterile, single-use PIEZOSURGERY ® medical inserts can be connected . Channel 2 enables the PIEZOSURGERY medical+ ® handpiece to be used, to which the sterile, single-use PIEZOSURGERY medical+ ®...
  • Page 17 INSTALLATION AND CONFIGURATION Tighten the extension using the PIEZOSURGERY medical L torque wrench; ® For correct use of the Mectron torque wrench, proceed as follows: Insert the extension into the PIEZOSURGERY medical L torque wrench ® as shown; Hold the central body of the handpiece firmly;...

  • Page 18: Assembly Of The Inserts

    Fasten the insert using the PIEZOSURGERY ® medical or PIEZOSURGERY medical+ ® torque wrench . To use the Mectron torque wrench correctly, proceed as follows: Insert the insert into the wrench as shown; CORRECT CAUTION: Do not use the PIEZOSURGERY medical L torque ®...

  • Page 19: Description Of Commands

    INSTALLATION AND CONFIGURATION 04.9 DESCRIPTION OF COMMANDS The PIEZOSURGERY plus screen is fitted with ® CAUTION: Do not use any sharp or a built-in touch screen . The commands pointed objects on the LCD screen; they can be selected by simply pressing the finger may damage the touch screen or screen .
  • Page 20 HANDPIECE BUTTON This enables the handpiece connected to the specific working channel to be selected. The colour of the handpiece shows which handpiece has been connected: - Grey: PIEZOSURGERY medical handpiece, ® - Black: PIEZOSURGERY medical+ handpiece . ® Depending on the handpiece inserted, the related settings screen is shown .
  • Page 21 INSTALLATION AND CONFIGURATION INSERT SETTINGS BUTTONS Depending on the insert selected, the predefined irrigation and power type settings are shown . By using the “-” and “+” buttons, the quantity of irrigation and power type level can be altered within the range established by the manufacturer .

  • Page 22: Device Configuration

    04.10 DEVICE CONFIGURATION Upon switching the device on, when at least one handpiece is connected, the settings selection screen will appear . The MT family is predefined, together with the relevant list of inserts . If you wish to change family, press the relevant button .
  • Page 23 INSTALLATION AND CONFIGURATION Confirm the desired settings by pressing OK . The foot pedal button is shown, thereby indicating that the channel is ready for use . Press the foot pedal to start treatment . The foot pedal button starts to flash, showing that the device is functioning correctly .

  • Page 24: Changing The Device Configuration

    04.11 CHANGING THE DEVICE CONFIGURATION NOTE: while the device is being used, the configuration functions are disabled. CHANGING THE SETTINGS to change the IRRIGATION and POWER settings, press the “-” and “+” buttons . The device will go back to the stage described under point 5 .

  • Page 25: Foot Pedal Button

    DO NOT use the WARNING: Use of non-original device and its accessories if damage is Piezosurgery/ Mectron inserts: this can apparent . Contact Piezosurgery Inc . if the definitively damage the threading of the abnormalities concern the device .
  • Page 26 . cooled completely before reusing . CAUTION: Never force the connector WARNING: Only use original Mectron onto the connector cord-handpiece of accessories and spare parts . the machine body as this may damage...
  • Page 27 INSTALLATION AND CONFIGURATION WARNING: The patient must not WARNING: The PIEZOSURGERY ® come into contact with the machine body plus device is intended for bone cutting . or foot pedal . However, prolonged contact and/or excessive force of the instrument WARNING: Do not change the insert tip on soft tissues should be avoided when the handpiece is operating;...

  • Page 28: Important Information On Inserts

    04.14 IMPORTANT INFORMATION ON INSERTS WARNING: - The insert must be kept moving at all - Do not alter the shape of the inserts by times . If the insert is blocked, the bone bending or prying them in any way . This may overheat .

  • Page 29: Switching The Device Off

    INSTALLATION AND CONFIGURATION 04.15 SWITCHING THE DEVICE OFF Shutting down the device Use the SHUTDOWN button to close the work session . Confirmation of closure will be requested. Select the confirm button to proceed with shut-down, or X to return to the working screen .

  • Page 30: Maintenance

    . 1 Disconnect the device from the electricity; Replace it when damaged with an original Piezosurgery/ Mectron spare part . 2 If it is not likely to be used for a long time, replace the device in its original packaging and store in a safe place;...

  • Page 31: Technical Data

    Adjustable on the touch screen: 7 power levels, from 1 to 7 For each insert, the minimun and maximum power levels are preset by Mectron . Peristaltic pump capacity: Adjustable on the touch screen: 5 flow levels, from minimum 4 ml/min to maximum approximately 81 ml/min .

  • Page 32: Electromagnetic Compatibility En 60601-1-2

    07.1 ELECTROMAGNETIC COMPATIBILITY EN 60601-1-2 WARNING: Contraindications. WARNING: Portable and mobile radio Interference with other equipment. communication appliances may affect Although PIEZOSURGERY plus complies correct device function . ® with standard IEC 60601-1-2, it may WARNING: Contraindications. interfere with other equipment located Interference by other equipment. nearby . PIEZOSURGERY plus must not be ®...
  • Page 33 TECHNICAL DATA Guidance and manufacturer’s declaration - Electromagnetic immunity The PIEZOSURGERY plus device is designed to work in the electromagnetic environment ® specified below. The client or user of the PIEZOSURGERY plus device should always make ® sure that it is used only in such environment . Electromagnetic Immunity IEC 60601...
  • Page 34 Guidance and manufacturer’s declaration - Electromagnetic immunity The PIEZOSURGERY plus device is designed to work in the electromagnetic environment ® specified below. The client or user of the PIEZOSURGERY plus should always make sure that ® it is used only in such environment . Immunity IEC 60601 Compliance Electromagnetic environment test...
  • Page 35 TECHNICAL DATA Recommended separation distances between portable and mobile RF communications equipment and the PIEZOSURGERY plus device ® The PIEZOSURGERY plus device is designed to work in an electromagnetic environment ® in which RF radiated disturbances are kept under control . The purchaser or user of the PIEZOSURGERY plus device can contribute to prevent electromagnetic interference by ®...

  • Page 36: Troubleshooting

    TROUBLESHOOTING 08.1 DIAGNOSTIC REPORTS AND SOLUTIONS The PIEZOSURGERY plus is equipped with a diagnostic circuit to detect any device operating ® anomalies and shows them on the display using the “MED-XXX” alarms . There are three different types of alarms: 1. Blocking: These alarms interrupt device operation, preventing use of the individual channel or...
  • Page 37 TROUBLESHOOTING Error Message Action needed Description MED - 001 Replace the handpiece . Malfunction of the syntonic Replace the handpiece circuit or faulty handpiece . MED - 002 Replace the handpiece . Malfunction of the syntonic Replace the handpiece circuit or faulty handpiece . MED - 004 Please check that the Malfunction of the syntonic Please check that the...
  • Page 38 Error Message Action needed Description MED - 028 Check that the settings Anomaly in external power External power supply are correct and continue supply . problem. Check the operating . settings MED - 029 Contact Piezosurgery Inc.’s Module interface program Channel out of use Service Centre immediately . execution error signal . MED - 030 - The device is functioning Internal process execution...
  • Page 39 TROUBLESHOOTING Error Message Action needed Description MED - 049 “SHUTDOWN” the device then Data synchronization The data need to be start it again . If the problem needed . synchronised. persists, contact Piezosurgery “SHUTDOWN” the device Inc.’s Service Centre. then start it again From MED - 050 to “SHUTDOWN” the device then Internal problem . MED - 058 start it again .

  • Page 40: Quick Troubleshooting Guide

    . the message shown . The screen shows an error message. The insert is blocked . Unscrew the insert and screw back on correctly A faint whistle can be using the Mectron torque heard coming from the wrench . PIEZOSURGERY medical ® (see paragraph 04.8) handpiece The irrigation circuit has not Fill the irrigation circuit during operation.
  • Page 41 Possible cause Solution The peristaltic pump tube is Only use original spare parts not the correct size . produced by Mectron . The insert is blocked Unscrew the insert from the handpiece and free up the insert water passage by blowing compressed air through it .

  • Page 42: Replacing The Fuses

    08.3 REPLACING THE FUSES WARNING: Switch the device off. Always turn the device off by means of the main switch and disconnect it from the electrical power socket before acting as follows . Insert the flat tip of a screwdriver into the recess in the fuse box below the power socket, and use it as a lever;...

  • Page 43: Packaging And Unpacking

    PACKAGING AND UNPACKING PACKAGING AND UNPACKING Package the device as shown in the figure CAUTION: Remove all accessories below . before removing the device body . To unpack, reverse all steps below .

  • Page 44: Limited Warranty

    . of the product, or a replacement of the The manufacturer, Mectron S .p .a ., warrants product . to the first original purchaser (customer) that If upon examination by Piezosurgery Inc .

  • Page 45: Customer Service - Returns And/Or Repairs

    Italian version will have pertinence . Texts, images, and graphics of this manual are property of Mectron S .p .A ., Carasco, Italy . All rights reserved . The contents cannot be copied, distributed, changed, or made available to third parties without the written approval of...
  • Page 47 NOTES...

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