mectron PIEZOSURGERY plus Use And Maintenance Manual
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mectron PIEZOSURGERY plus Use And Maintenance Manual

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USE AND MAINTENANCE MANUAL
0051

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  • Page 1 USE AND MAINTENANCE MANUAL 0051...
  • Page 3 Copyright © Mectron S.p.A. 2021. All rights reserved. No part of this document can be reproduced in any form without the written consent of the copyright owner.

  • Page 4: Table Of Contents

    TABLE OF CONTENTS Introduction Intended Use of PIEZOSURGERY® plus Description of the Device 1.2.1 Users Disclaimer Safety Requirements Symbols Identification Data 2.1 Device Identification Label 2.2 Handpiece Identification Data 2.3 Inserts Identification Data Delivery 3.1 List of the Components in the Standard Kit 3.2 List of the Accessories Installation and Configuration Safety Requirements During Installation Device Installation Switching On the Device 4.4 Language Selection 4.5...
  • Page 5 Packaging Warranty...
  • Page 6 PAGE INTENTIONALLY LEFT BLANK...

  • Page 7: Introduction

    The words WARNING, CAUTION and NOTE MECTRON is committed to the continuous contained in this document, carry special updating of our products, which may entail meaning and must be carefully reviewed. changes to components of the device.

  • Page 8: Description Of The Device

    ® insert and set the power type and irrigation inserts can be connected. Channel 2 enables the PIEZOSuRGERY values within a range pre-established by the ® manufacturer Mectron. medical+ handpiece to be used, to which the sterile, single-use PIEZOSuRGERY medical+ ® WARNING: To prevent the treated parts inserts can be connected.

  • Page 9: Safety Requirements

    9. use of non-original Piezosurgery/ CAUTION: The back-up battery must be Mectron inserts, used according to the replaced with a CR2032 type identical battery, settings designed and tested on original by Piezosurgery Inc.’s Service. Piezosurgery/Mectron inserts. Correct use of settings is only guaranteed with Improper use, damage and/or incorrect original Piezosurgery/Mectron inserts;...
  • Page 10 Replace the handpiece immediately. wrench or all other sterilisable accessories in WARNING: Only use original the autoclave, wait for them to have cooled Piezosurgery/Mectron accessories and spare completely before reusing. parts. WARNING: Breakage and wear of the CAUTION: No changes can be made to inserts.

  • Page 11: Symbols

    INTRODuCTION Symbols Symbol Description Symbol Description Device compliant with Regulation (Eu) Nemko Mark 2017/745. Notified uL CSA compliance 0051 body: IMQ S.p.A. Caution, read the Medical Device Instructions For Use Operating Instructions Manufacturer Date of manufacture Serial Number Lot Number Product Number Single-use Do not resterilize Sterilized with Ethylene use-by date Oxide (EO) Can be sterilized in autoclave up to a Non-sterile maximum temperature...
  • Page 12 Symbol Description Symbol Description Do not touch moving General warning parts Temperature limitation Humidity limitation for for transport and transport and storage storage Atmospheric pressure Do not use if package is limitation for transport damaged and storage Graphic symbol Graphic symbol intended identify intended identify the Channel 1 (CH1) the Channel 2 (CH2) used to connect the used to connect the...

  • Page 13: Identification Data

    1.5 on page 5 Handpiece Identification Data Each handpiece is laser-marked with (refer to Figure 1 at page 8 • its serial number (SN); • its product number (REF); • its date of manufacturing; • the device name (PIEZOSURGERY® medical o PIEZOSuRGERY® medical +); • the Mectron logo; • HIBC 128 Data Matrix; • CE, MD, Applied Part and Sterilizable symbols. NOTE: The complete list of symbols and their description are shown in Chapter 1.5 on page...

  • Page 14: Inserts Identification Data

    + Figure 1 – Handpiece identification data Inserts Identification Data Each insert is laser-marked with the following data: • the insert model name (Ref. 1); • the Mectron logo (Ref. 2); • the batch number to which the insert belongs (Ref. 3); • the “Single-use” and “CAuTION: Read the Instructions For Use” symbols (Ref. 4). Each extension/insert cover is laser- marked with the following data: •...

  • Page 15: Delivery

    C. 2 Stands for Solution Bag; Case. use and Maintenance Manual, Cleaning and Sterilization Manual; List of the Accessories PIEZOSURGERY® plus can be equipped with accessories available separately: Handpiece: K. PIEZOSURGERY® medical single use irrigation kit (distributed by Mectron). • PIEZOSuRGERY® medical +, The packaging of the device cannot undergo supplied with the cord and the strong impacts contains electronic connector protective cap, components, therefore the transport and the •...

  • Page 16: Installation And Configuration

    INSTALLATION AND CONFIGURATION To guarantee proper device functionality, Explain to the user all the possible it must be installed by an authorised device configurations; Piezosurgery Inc. technician. The device must Explain how to clean, sterilise and be installed in a suitable and convenient place maintain the system; for its use. Fill in the installation and hospital The technician will need to carry out the personnel training forms;...

  • Page 17: Device Installation

    INSTALLATION AND CONFIGuRATION CAUTION: Before connecting the CAUTION: Do not allow the machine handpiece cord to the device, check that the body or foot pedal to become wet. If liquid electrical contacts are perfectly dry. Dry with should enter the machine body or foot pedal, compressed air if necessary. this may cause damage.
  • Page 18 NOTE: the foot pedal is provided with a bracket that, if positioned vertically, enables it to be moved to the most appropriate place for use, with no need to touch it with hands. The bracket can also be positioned horizontally, if not in use; Insert the solution bag stand into the proper holes;...

  • Page 19: Switching On The Device

    INSTALLATION AND CONFIGuRATION Switching On the Device Switch the device on by means of the general switch on the back of the device body, taking care not to press the foot pedal down during this stage. Language Selection CAUTION: The language can be selected only if no handpieces are connected to the device. Switch the device on without any handpieces connected.

  • Page 20: Irrigation Kit Installation

    To apply, press the confirm button; The selected language selected is now the predefined option. Now, the handpieces can be connected and the device can be configured; NOTE: to change the language during use, disconnect the handpieces and proceed with the configuration. Irrigation Kit Installation Open the previously-sterilised handpiece packaging and the irrigation kit, removing the tubing and the fixing clips. Connect the end of the irrigation tube to the specific attachment on the handpiece. Fix the irrigation tube to the cord- handpiece by using the clips supplied;...

  • Page 21: Connection Of The Handpieces To The Device

    INSTALLATION AND CONFIGuRATION Place the irrigation bag onto the appropriate stand; Remove the protection cap of the spike; Insert the spike into the irrigation bag; NOTA: The irrigation bag holder stand must be used with bags of up to a maximum of 1000 ml capacity. Open the air inlet on the spike, before proceeding with the operation. Open the irrigation tube clamps, if closed; Connection of the Handpieces to the Device Channel 1 (CH1) allows the connection of the PIEZOSURGERY...

  • Page 22: Disconnection Of The Handpieces From The Device

    4.7 Disconnection of the Handpieces from the Device To disconnect the connector of the cord- To disconnect the connector of the cord- handpiece from channel 1 (CH1), simply grasp handpiece from channel 2 (CH2), instead, the connector firmly and pull it out. proceed as follow: CAUTION: To avoid damaging the cord- handpiece, connect and/or disconnect it, holding it by the connector only. Never pull the cord. The cord-handpiece connector for channel 2 (CH2) is equipped with a retention mechanism.

  • Page 23: Installation Of Piezosurgey® Medical+ Insert Extension And Cover

    ® handpiece till the end of the threading; Tighten the extension using the PIEZOSURGERY medical L torque ® wrench; For the correct use of the Mectron torque wrench, proceed as follows: Insert the extension into the PIEZOSURGERY medical L torque ®...
  • Page 24 Hold the central body of the handpiece firmly; CAUTION: Do not grasp the end and/or cord of the handpiece; only hold the central body. Do not rotate the handpiece; simply hold it firmly and click! rotate the wrench, only. Turn the wrench in a clockwise direction until the clutch engages (the outer part of the wrench slips, compared to the handpiece, producing mechanical...

  • Page 25: Installation 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: Place the insert into the wrench as shown; CAUTION: Do not use the PIEZOSuRGERY® medical L torque wrench to fasten the inserts. The PIEZOSuRGERY® medical L torque wrench must only be used to fasten the extension.

  • Page 26: 4.10 Commands Description

    Hold the central body of the handpiece firmly. Turn the wrench in a clockwise direction until the clutch engages (the outer part of the wrench slips, compared to the handpiece, producing mechanical a clicking sounds ”CLICK”). The insert is click! now properly tightened;...
  • Page 27 INSTALLATION AND CONFIGuRATION PUMP BUTTON Enables the irrigation circuit to be filled before starting the treatment, in order to operate with the required irrigation. The colour of the symbol identifies the handpiece to which it is associated to. INSERT FAMILY BUTTONS Enable the selection of the insert family: • MT: osteotomy • MP: osteoplasty, curettage •...
  • Page 28 In the following, there is an example of the graphical interface: Figure 2 – Main window - example The buttons: • Shutdown; can be displayed in three different colors to identify the status of the associated function. • Handpiece; The colors and states are described below: • Pump; • Insert Family; • Insert; • Insert Settings; WHITE Indicates that the button is not selected.

  • Page 29: Device Configuration

    INSTALLATION AND CONFIGuRATION 4.11 Device Configuration Upon switching the device on, if at least one handpiece is connected, the settings selection screen will appear. The MT family, together with the relevant list of inserts, is the default setting. To change insert family, press the relevant insert family button; Select the desired insert; For each insert, the system automatically set the optimal working settings. By using the “-” and “+” buttons, the irrigation and...

  • Page 30: Modify The Device Configuration

    Confirm the desired settings by pressing the OK button; The foot pedal button is shown, indicating that the channel is ready for use. Press the foot pedal to start the treatment. The foot pedal button starts to blink, indicating that the device is working properly. 4.12 Modify the Device Configuration NOTE: While the device is operating, the configuration options are disabled.

  • Page 31: Foot Pedal Button

    INSTALLATION AND CONFIGuRATION CHANGING THE INSERT To change the insert, press the desired insert button. Proceed with the step 3 described in Chapter 4.11 on page 23. CHANGING THE INSERT FAMILY To change the insert family, press the desired family button. Proceed with the step 2 described in Chapter 4.11 on page 23. CHANGING THE WORKING CHANNEL To change the working channel, press the relevant handpiece button.

  • Page 32: Safety Requirements Before And During Use

    Service Centre) are delivered in NON-STERILE conditions and MuST be processed before WARNING: Use of non-original the use, in accordance with the instructions Piezosurgery/Mectron inserts: this can provided in the Cleaning and Sterilisation completely damage the threading of the Manual. Subsequent uses: after each handpiece, affecting the proper operation treatment, clean and sterilise all reusable and causing injury to the patient.
  • Page 33 INSTALLATION AND CONFIGuRATION WARNING: Check the level of WARNING: Check that the insert physiological solution contained in the mounted into the handpiece is the same physiological irrigation bag. Replace the one as shown on the display, otherwise, physiological irrigation bag with a new one performance will be affected. before it is completely empty. CAUTION: To avoid damaging the foot WARNING: Sterile single-use material.
  • Page 34 WARNING: Breakage and wear of the WARNING: The PIEZOSuRGERY® plus inserts. The high-frequency vibrations and device is intended for bone surgery. However, general wear and tear can, very occasionally, prolonged contact and/or excessive force of lead to insert breakage. Do not bend, change the instrument tip on soft tissues should be the shape or sharpen an insert in any way. avoided as this may cause thermal and/or Bending an insert or applying leverage to it blunt injury. Take particular care when sharp can cause it to break. Deformed or otherwise inserts are used.

  • Page 35: Important Information On Inserts

    INSTALLATION AND CONFIGuRATION 4.15 Important Information on Inserts WARNING: the inserts, consult the accompanying Instructions for Use. • The insert must always be kept moving. • Do not alter the shape of the inserts by If the insert is blocked, the bone may bending or prying them in any way. This overheat. We recommend using a may lead to their breakage. continuous movement to minimise contact between the tip and the tissue. • Do not use an insert that has been We recommend using high levels of deformed in any way.

  • Page 36: Switching Off The Device

    4.16 Switching Off the Device Shutting down the device use the SHuTDOWN button to close the work session. A confirmation window will appear. Press the confirmation button to proceed with the shut-down, or the cancel button to return to the working screen. Switching off the device When switching off message appears, switch the device off by means of the switch on located the rear side. Wait 4 seconds before restarting the device.

  • Page 37: Maintenance

    The customer is entitled to deliver the old • Sterile irrigation kit after each device for disposal to the retailer supplying intervention; the new equipment. Instructions on correct disposal are available from Mectron. • Torque wrench, dispose of when worn or Non-compliance with the previous points may broken. produce a fine in accordance with the Waste Disposable materials and materials that imply...
  • Page 38 Adjustable on the touch screen: 7 power levels, from 1 to 7. Power settings NOTE: For each insert, the minimum and maximum power levels are preset by Mectron. Configurable via the touch screen: 5 flow levels, from a minimum of 4 ml/ min to a maximum of approximately 81 ml/min. Peristaltic pump capacity NOTE: For each insert, the minimum and maximum irrigation levels are preset by Mectron.

  • Page 39: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    EMC precautions and must be installed distance from life-support equipment. If and commissioned according to the EMC necessary, however, prior their use, please information provided in this chapter. check and monitor that the device and all other equipment works correctly in that WARNING: Only use original layout. Piezosurgery/Mectron accessories and spare parts. The use of cables and accessories not WARNING: Portable and mobile radio supplied by Piezosurgery/Mectron might communication appliances may affect proper negatively affect the EMC performances. device operation. 7.1.1 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions PIEZOSuRGERY® plus is designed to operate in the electromagnetic environment specified...
  • Page 40 Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions The PIEZOSURGERY® plus is suitable Class A CISPR 11 for use in all establishments other than domestic, and may be used in domestic Harmonic emissions Class A establishments and those directly IEC 61000-3-2 connected to the public low voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded.

  • Page 41: Accessible Parts Of The Casing

    TECHNICAL DATA 7.1.2 Accessible Parts of the Casing PIEZOSuRGERY® plus is designed to operate in the electromagnetic environment specified below. The customer or the user of PIEZOSuRGERY® plus should ensure that it is used in such environment. Basic EMC Electromagnetic Phenomenon standard or test Immunity test levels Environment Guidance method The floor must be made of wood, concrete or ceramic Electrostatic ±8 kv on contact tiles. If the floor is covered...

  • Page 42: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    7.1.3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity 7.1.3.1 Power Connection A.C. Input PIEZOSuRGERY® plus is designed to operate in the electromagnetic environment specified below. The customer or the user of PIEZOSuRGERY® plus should ensure that it is used in such environment. Basic EMC Electromagnetic Phenomenon standard or test Immunity test levels Environment Guidance...
  • Page 43 TECHNICAL DATA d) If the frequency stepping skips over an ISM or m) r.m.s. , before modulation is applied. amateur band, as applicable, an additional test n) The ISM (industrial, scientific and medical) bands frequency shall be used in the ISM or amateur radio between 0,15 MHz and 80 MHz are 6,765 MHz to band. This applies to each ISM and amateur radio 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz band within the specified frequency range. to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The e) Testing may be performed at other modulation amateur radio bands between 0,15 MHz and 80 MHz frequencies identified by the RISK MANAGEMENT are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz PROCESS. to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, f) ME EQuIPMENT and ME SYSTEMS with a d.c. power...

  • Page 44: Points Of Contact With The Patient

    7.1.3.2 Points of Contact with the Patient PIEZOSuRGERY® plus is designed to operate in the electromagnetic environment specified below. The customer or the user of PIEZOSuRGERY® plus should ensure that it is used in such environment. Basic EMC Electromagnetic Phenomenon standard or test Immunity test levels Environment Guidance method The floor must be made of wood, concrete or ceramic Electrostatic ±8 kv on contact tiles. If the floor is covered...

  • Page 45: Parts Accessible To The Input / Output Signals

    TECHNICAL DATA 7.1.3.3 Parts Accessible to the Input / Output Signals PIEZOSuRGERY® plus is designed to operate in the electromagnetic environment specified below. The customer or the user of PIEZOSuRGERY® plus should ensure that it is used in such environment. Basic EMC Electromagnetic Phenomenon standard or test Immunity test levels Environment Guidance method The floor must be made of wood, concrete or ceramic Electrostatic ±8 kv on contact tiles. If the floor is covered...

  • Page 46: Specifications Of The Tests For The Immunity Of The Accessible Parts Of The Casing To The Wireless Rf Communications Device

    7.1.4 Specifications of the tests for the Immunity of the Accessible Parts of the Casing to the Wireless RF Communications Device PIEZOSURGERY® plus is designed to operate in an electromagnetic environment in which radiated RF disturbances are under control. The customer or the user of PIEZOSuRGERY® plus can help prevent electromagnetic interference by ensuring a minimum distance between the mobile and portable RF (transmitters) communication devices and PIEZOSuRGERY® plus, as recommended, in relation to the maximum output power of radiocommunications equipment.

  • Page 47: Troubleshooting

    TROuBLESHOOTING NOTE: If necessary to achieve the WARNING: Portable RF communication IMMuNITY TEST LEvEL, the distance equipment (including peripheral devices as between the transmitting antenna and the antenna cables and external antennas) must PIEZOSURGERY® plus may be reduced to 1 not be used closer than 30 cm (12 inches) to m. The 1 m test distance is permitted by IEC any part of the device PIEZOSURGERY® plus, 61000-4-3. including the cables specified by the manufacturer.
  • Page 48 Information Message These conditions indicate the presence of an anomaly; the device continues to operate, but with limited functionalities. The messages are displayed periodically, one by one, with the identifier of the current message and the indication of the total number of anomalies detected. Error Message Actions Required Description MED - 001...
  • Page 49 TROuBLESHOOTING Error Message Actions Required Description MED - 021 use the channel that works. Checksum error, firmware Channel out of use. Contact technical assistance. module corruption. MED - 022 The device is working Checksum error, firmware Internal problem: please properly: contact the module corruption. contact assistance. Piezosurgery Inc.’s Service Centre as soon as possible. The device is not working properly: contact immediately the Piezosurgery Inc.’s Service Centre. MED - 028 Check that the correctness Mains power supply External power supply of the settings and then anomaly.
  • Page 50 Error Message Actions Required Description MED - 043 Select the desired language Language selection not Default language - English. by using the “language” properly working: English set button. If the problem as the default language. persists, contact the Piezosurgery Inc.’s Service Centre. MED - 044 Complete the current Problem in the internal data The data need to be operation and then run the synchronization.

  • Page 51: Troubleshooting Quick Guide

    The screen shows an error related to the displayed be taken according to the message. message. message displayed. Unscrew the insert and screw it back correctly by using the The insert is not properly Mectron torque wrench. tightened into the (Refer to Chapter 4.8 on When operating, the handpiece. page 17 Chapter 4.9...
  • Page 52 Problem Probable Cause Solution The peristaltic pump tube is use original Piezosurgery/ not of the correct size. Mectron spare parts, only. Unscrew the insert from the handpiece and unclog the insert water passage The insert is clogged. by blowing compressed air through it. If the problem persists, replace the insert with a new one.

  • Page 53: Fuses Replacement

    TROuBLESHOOTING Fuses Replacement 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 proceeding. use a small flat head screwdriver to carefully pry off the fuse tray located above the mains socket; Remove the fuse tray; WARNING: Replace the fuses with others respecting the characteristics indicated in Chapter 7 on page 31 Re-insert the fuse tray in its slot.

  • Page 54: Customer Service - Returns And/Or Repairs

    Customer Service - Returns and/or Repairs If you need technical assistance regarding the Please provide the following information: use, or you encounter a problem that requires • Data of the owner with telephone servicing or repair, contact PIEZOSURGERY number; Inc. Customer Service at (1.888.87-PIEZO). • Product name; Returning products for any reason, requires •...
  • Page 55 PACKAGING PACKAGING Pack the device as shown in the following CAUTION: Remove all the accessories figure. before removing the device core system. To unpack, reverse all steps below.
  • Page 56 If upon examination by PIEZOSuRGERY Inc. ® The manufacturer, Mectron S.p.A., warrants service personnel it is determined that the to the first original purchaser (customer) that malfunction is caused by abnormal wear and their products have been tested, inspected tear or by damage caused by misuse, abuse, and shipped in proper working order.
  • Page 60 Manufacturer: Distributed in U.S. by: Mectron S.p.A. via Loreto 15/A 16042 Carasco (Ge) Italy Tel. +39 0185 35361 850 Michigan Avenue Fax +39 0185 351374 Columbus, Ohio 43215 www.mectron.com Phone 614.459.4922 e-mail: mectron@mectron.com Fax 614.459.4981 www.piezosurgery.us e-mail: info@piezosurgery.us Reseller - Rivenditore - Wiederverkäufer - Revendeur - Revendedor...

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