mectron compact piezo LED Use And Maintenance Manual
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mectron compact piezo LED Use And Maintenance Manual

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compact piezo LED
USE AND MAINTENANCE MANUAL
0051

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  • Page 1 LED USE AND MAINTENANCE MANUAL 0051...
  • Page 2 LeD...
  • Page 3 Copyright © mectron S.p.a. 2022. 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

    LeD TABLE OF CONTENTS Introduction intended Use Description of the Device Disclaimer Safety precautions Symbols Identification Data 2.1 Handpiece Identification Data 2.2 Insert Tips Identification Data Delivery List of components commands 4.2 Switching the Device On and Off Safety precautions Before and During Use instructions for Use important information on the insert tips...
  • Page 6 LeD PAGE INTENTIONALLY LEFT BLANK...

  • Page 7: Introduction

    WARNING, CAUTION and NOTE contained mectron is committed to continuously update in this document, carry special meaning its products with possible modifications to and must be carefully reviewed. Depending device components.

  • Page 8: Description Of The Device

    •...

  • Page 9: Safety Precautions

    INTRODuCTION • Breach of the requirements and the page 17 of this manual; information contained in chapter 4.5 on • unauthorized repairs in accordance with page 14 of this manual; the indications contained in chapter 10.2 • Breach of the requirements and the on page 42 of this manual. information contained in Chapter 6 on Safety Precautions WARNING: Contraindications.
  • Page 10 LeD if the layer of titanium nitride (golden WARNING: Infections control. surface), where present, is visibly worn, the to ensure maximum safety of the patient and insert tip must be replaced. the use of a worn the operator, before using all the reusable insert tip decreases its efficiency. parts and accessories, make sure you have...

  • Page 11: Symbols

    INTRODuCTION Symbols Symbol Description Symbol Description Device compliant with Regulation (Eu) MEMKO Mark 2017/745. Notified uL-CSA compliance 0051 body: imQ S.p.a. caUtioN, See consult instructions instructions for use. for use manufacturer Date of manufacture manufacturer, year of manufacture included Serial Number (YYYY= year) YYYY Lot Number product Number Single-use expiring date...

  • Page 12: Identification Data

    SLIM MANIPOLO ABLATORE 114000000 SLIM Data Matrix HIBC 128 03120238 Insert Tips Identification Data On each insert tip is laser-marked the name the insert tip itself (Reference 2), the MECTRON logo (Reference 3) and the lot number to which the insert tip belongs (Reference 4).

  • Page 13: Delivery

    DELIvERY DELIVERY List of Components Figure 1 a pagina 9. can be ordered separately (see table 4 a compact piezo LED is supplied with the pagina 8). standard equipment (see table 2 a pagina NOTE: Both the items included in the 7), a set of variable accessories depending standard supply and all accessories can be on the configuration and client requests (see ordered separately by the client.
  • Page 14 Scaler Handpiece 03120142 SCALER HANDPIECE) Front cone for LED SCALER Front cone for LED handpiece 03020158 HaNDpiece Front cone for LED SCALER Front cone without light 03020171 HaNDpiece Front cone, light guide and Light guide kit 02900146 decorative ring for SLim scaler handpiece Table 4 – accessories available for separate order. b) produced by mectron.
  • Page 15 Do not stack multiple boxes in order to avoid and to store the device during long periods compressing the underlying packaging. of inactivity. All the material shipped by MECTRON have WARNING: Before starting the treatment, been inspected upon their delivery. always make sure to have a stock of material the device is shipped duly protected and (handpiece, inserts, wrenches) to use in the packed.

  • Page 16: Use

    LeD Commands compact piezo LED offers a wide range of power settings: from a sub-gengival perio treatment in soft mode to a more aggressive scaling. Read the manual of use of the dental chair on which compact piezo LED is installed in order to have the complete description of the available power settings. Switching the Device On and Off Read the manual of use of the dental chair on which compact piezo LED is installed in order to know how to switch the device on and off, and how to control the LED light on the front end of the handpiece. Safety Precautions Before and During Use WARNING: Before starting to operate CAUTION: only use insert tips with water with the device, make sure of having stock passage when performing treatments that material (handpiece, insert tips, wrenches) require irrigation. available to use in case the device fails or to WARNING: Treatments that require inconveniences.
  • Page 17 WARNING: Do not change the insert tip WARNING: Breakage and wear-out of while the handpiece is operating, to prevent the insert tips. High frequency oscillations causing wounds to the operator. During the and wear-out may, in rare circumstances, lead intervention on the patient, do not perform to the breakage of the insert tip. any maintenance tasks on the system. Deformed or otherwise damaged insert tips are susceptible to breakage during their use.

  • Page 18: Instructions For Use

    Screw in the preselected insert on the compact piezo LED handpiece until it comes into contact tighten the insert using the mectron torque wrench. For correct use of the Mectron torque wrench, proceed as follows: • place the insert inside the MECTRON torque wrench as shown in the figure;...
  • Page 19 • Firmly grip the body of the handpiece; CAUTION: Do not grab the handpiece by the nozzle and/or by the cord. Firmly hold the body of the handpiece and rotate only the torque wrench. Do not rotate the body during click! tightening. • Turn the torque wrench in a clockwise direction until the notch clicks (the external body of the torque wrench turns with respect to the body of the handpiece, emitting mechanical sounds); • The insert is now optimally locked; the position of the LeD light on the nose cone of the MANIPOLO ABLATORE LED (LED SCALER HANDPIECE - cod.

  • Page 20: Important Information On The Insert Tips

    • When the insert is used in the cracking must be replaced immediately. interproximal spaces, do not block the • Use original mectron insert tips only. Use instrument or leverage the operative of non-original insert tips, in addition part. the inserts must be left free to to voiding the warranty, damages the vibrate.

  • Page 21: Disassembling Of Parts For Cleaning And Sterilization

    DISASSEMBLING O F P ARTS F OR C LEANING A ND S TERILIzATION • in the treatment of endodontic root • Breakage and wear-out of the insert tips. canal therapy, never operate the files High frequency oscillations and wear- when they are outside the root canal out may, in rare circumstances, lead to to avoid breaking them. To prevent the breakage of the insert tip. breakage, create a smooth path with •...
  • Page 22 LeD Disconnect the handpiece from the relative cord; CAUTION: Do not try to unscrew or turn the connector when disconnecting the handpiece. the connector can be damaged. Unscrew the nose cone from the handpiece. NOTE: the nose cone has a light pipe.

  • Page 23: Cleaning And Sterilization

    250 reconditioning cycles. 6.1 Cleaning of the Accessories that can be Sterilised...

  • Page 24: Required Materials

    LeD 6.1.1 Required Materials • Enzymatic detergent at pH 6-9; CAUTION: To disinfect the device and/ or its accessories, it is recommended the use • Water; of water-based disinfectant solutions with • container for immersion in the aneutral pH (pH7). enzymatic liquid; DO NOT USE as disinfectants: • ultrasonic tank; • Alcohol-based disinfectant solutions; • Clean, soft cloths with low fibre release; • Peracetic acid, Formaldehyde, • Brush with soft nylon bristles;...

  • Page 25: Scaler Handpiece

    CLEANING AND STERILIzATION 6.1.3 Scaler Handpiece clean the surface of the handpiece and of its connector using a clean, soft, lint free, cloth moistened with the prepared enzymatic detergent solution and, if need be, disinfect with no-aggressive disinfectant solution with neutral pH (pH7), according to the disinfectant’s manufacturer;...

  • Page 26: Insert Tips

    LeD • external and internal parts of light pipe. thoroughly rinse the front cone under running warm tap water and then under demineralized water to eliminate any residual detergent; Hold the handpiece with its front end pointed downward; Rinse thoroughly the front end and the...
  • Page 27 CLEANING AND STERILIzATION During the immersion in the enzymatic solution, gently brush all surfaces to remove any visible dirt. Use a clean, soft nylon bristle brush for external surfaces, a clean, soft nylon bristle brush for internal cavities and crevices. NOTE: carefully brush all the following parts of the insert tip for about 20 seconds: •...
  • Page 28 LeD Rinse the internal duct of the insert tip with demineralized water at a pressure of 3.8 bar for at least 10 seconds in order to eliminate any residual dirt; x10 sec. H₂O Place the insert tip in the ultrasonic tank, submerged in the enzymatic detergent solution at 24 ° c ± 2 ° c and run a cycle of at least 20 minutes;...

  • Page 29: Torque Wrench

    CLEANING AND STERILIzATION Rinse the insert tip in demineralized water; Rinse the internal duct of the insert tip with demineralized water at a pressure of 3.8 bar for at least 10 seconds in order to eliminate any dirt residues. x10 sec. H₂O Process validated by independent bodies with enzymatic detergent. 6.1.5 Torque Wrench Place the torque wrench horizontally in a clean container. add enough of the enzymatic detergent solution to completely cover the torque wrench.
  • Page 30 LeD While immersing in the enzymatic solution, gently brush all surfaces to remove any visible dirt. Use a clean, soft nylon bristle brush for external surfaces, a clean, soft nylon bristle pipe cleaner for internal cavities and crevices.

  • Page 31: Cleaning Check

    CLEANING AND STERILIzATION Remove the torque wrench from the ultrasonic cleaning tank and rinse it under running water to remove any residual detergent. Brush the internal and external surfaces of the torque wrench with a clean brush with soft nylon bristles, under running water. Process validated by independent bodies with enzymatic detergent. 6.2 Cleaning Check 6.2.1 Required Materials •...
  • Page 32 LeD Repeat the control operations for the other accessories (inserts, tightening wrenches), repeating if necessary the cleaning cycle.

  • Page 33: Drying And Lubrication

    CLEANING AND STERILIzATION 6.3 Drying and Lubrication 6.3.1 Necessary Materials • compressed air; NOTE: Adopt a medical-grade lubricant approved by FDA, for example, the NSK Pana- • Soft cloth with low fibre release; Spray or similar. • medical grade lubricant. thoroughly dry all parts of the scaler handpiece, scaler nose cone, and light pipe by blowing them with compressed air; CAUTION: the scaler handpiece electrical contacts must be dry at the start and end of the sterilisation cycle, before the cord is connected to the...

  • Page 34: Sterilization

    LeD Dry the insert tips torque wrench using a soft cloth with low fibre release; Lubricate the insert tips torque wrench with FDA approved medical-grade lubricants by spraying it directly onto the peripheral contact surface inside the torque wrench, as indicated in the figure. CAUTION: Do not use oil or silicone- based lubricants. after having applied the lubricant, remove any excess oil using a clean lint- free cloth. 6.4...
  • Page 35 CLEANING AND STERILIzATION Seal the scaler handpiece (without inserts), scaler nose cone, and light pipe individually and separately in disposable sterilisation bags. CAUTION: use FDA approved, appropriately sized medical steam sterilisation pouch compliant with standard uNI EN ISO 11607-1. Seal the insert tips individually inside a disposable pouch for sterilization. Seal the torque wrench individually inside a disposable pouch for sterilization.

  • Page 36: Sterilization Method

    CAUTION: use FDA approved, displacement autoclave DO NOT ensure appropriately sized medical steam sterilisation pouch compliant with standard adequate sterilization of the lumens, cavities, recessed features of the instruments. uNI EN ISO 11607-1. the sterilisation process validated by mectron WARNING: use exclusively a pre-vacuum autoclave to sterilize the compact piezo LED S.p.A., in a pre-vacuum autoclave, guarantees sterilizable intruments. a SaL 10 by setting the parameters indicated below: CAUTION: Never use any other •...

  • Page 37: Maintenance

    Disposable materials and materials that the new equipment; instructions for proper imply a biological risk must be disposed disposal are available at MECTRON. of according to local regulations in force regarding hospital waste. WARNING: When handling the insert tips, pay particular attention to sharp, pointed and irregular parts to avoid any wound or injury.

  • Page 38: Technical Specifications

    LeD TECHNICAL SPECIFICATIONS Device compliant with Regulation (EU) class iia 2017/745 The class definition is delegated to the manufacturer of the dental chair incorporating compact piezo LED. Classification as per IEC/EN 60601-1 Applied part type B (insert tip) IP 20 (device) ip according to the indications provided by the manufacturer of the dentist’s unit According to the standard IEC 80601-2-60 Essential performance the device has no essential performance 60 sec. ON - 30 sec. OFF with irrigation Device for intermittent operation 30 sec. ON - 120 sec. OFF without irrigation...

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

    TECHNICAL SPECIFICATIONS Electromagnetic Compatibility IEC/EN 60601-1-2 WARNING: Contraindications. WARNING: The device requires specific Interference with other equipment emc precautions and must be installed even if complying with the standard iec and commissioned according to the emc 60601-1-2, compact piezo LED may interfere information provided in this chapter. with other devices in the vicinity. WARNING: the technician or the WARNING: portable and mobile radio manufacturer of the dental chair on which communication appliances may affect proper...

  • Page 40: Accessible Parts Of The Casing

    LeD 9.1.2 Accessible Parts of the Casing compact piezo LED is designed to operate in the electromagnetic environment specified below. The customer or user of compact piezo LED should always make sure that it is used only in such an 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 discharges IEC 61000-4-2 ±2 kv, ±4 kv, ±8 kv, with synthetic material, the (ESD) ±15 kv in aria relative humidity should be at least equal to 30 %. Portable and mobile RF...

  • Page 41: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    TECHNICAL SPECIFICATIONS 9.1.3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity 9.1.3.1 A.C. Input Power Connection compact piezo LED is designed to operate in the electromagnetic environment specified below. The customer or user of compact piezo LED should always make sure that it is used only in such an environment. Basic EMC Electromagnetic Phenomenon standard or test Immunity test levels environment - Guidance method The quality of the power electrical fast ±2 kv on contact supply should be that of a transients / IEC 61000-4-4 100 KHz repetition typical commercial or hospital bursts frequency a) l) o) environment.
  • Page 42 LeD a) the test may be performed at any one power input j) ME EQuIPMENT and ME SYSTEMS that does not have voltage within the compact piezo LED RATED voltage a surge protection device in the primary power circuit range. If the compact piezo LED is tested at one may be tested only at ± 2 kv line(s) to earth and ± 1 power input voltage, it is not necessary to re-test at kv line(s) to line(s). additional voltages. k) Not applicable to CLASS II equipment and systems. b) All compact piezo LED cables are attached during l) Direct coupling shall be used.

  • Page 43: Points Of Contact With The Patient

    TECHNICAL SPECIFICATIONS 9.1.3.2 Points of Contact with the Patient compact piezo LED is designed to operate in the electromagnetic environment specified below. The customer or user of compact piezo LED should always make sure that it is used only 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 discharges IEC 61000-4-2 ±2 kv, ±4 kv, ±8 kv, with synthetic material, the (ESD) ±15 kv in air relative humidity should be at least equal to 30 %. Portable and mobile RF communication devices should not be used near any conducted 0,15 MHz - 80 MHz part of the product, including...

  • Page 44: Parts Accessible To The Input / Output Signals

    LeD 9.1.3.3 Parts Accessible to the Input / Output Signals compact piezo LED is designed to operate in the electromagnetic environment specified below. The customer or user of compact piezo LED should always make sure that it is used only in such an 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 discharges IEC 61000-4-2 ±2 kv, ±4 kv, ±8 kv, with synthetic material, the (ESD) ±15 kv in air relative humidity should be at least equal to 30%. The quality of the power electrical fast ±1 kv on contact...

  • Page 45: Specifications Of The Tests For The Immunity Of The Accessible Parts Of The Casing To The Wireless Rf Communications Device

    TECHNICAL SPECIFICATIONS 9.1.4 Specifications of the Tests for the Immunity of the Accessible Parts of the Casing to the Wireless RF Communications Device compact piezo LED is designed to operate in an electromagnetic environment in which radiated RF disturbances are under control. The customer or the user of compact piezo LED can help prevent electromagnetic interference by ensuring a minimum distance between the mobile and portable RF (transmitters) communication devices and compact piezo LED, as recommended, in relation to the maximum output power of radiocommunications equipment.

  • Page 46: Troubleshooting

    LeD NOTE: If necessary to achieve the IMMuNITY WARNING: Portable RF communications teSt LeVeL, the distance between the equipment (including peripherals such transmitting antenna and compact piezo LED as antenna cables and external antennas) may be reduced to 1 m. the 1 m test distance should be used no closer than 30 cm ( 12 is permitted by IEC 61000-4-3. inches) to any part of the compact piezo LED device, including cables specified by the manufacturer. otherwise, degradation of the performance of this equipment could result.
  • Page 47 Contact an Authorized the handpiece is clogged. mectron Service center Unscrew and correctly screw the insert tip back by using the insert tip is not correctly the Mectron torque wrench tightened on the handpiece chapter 4.4 on page...

  • Page 48: Customer Service - Returns And/Or Repairs

    LeD 10.2 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 49: Warranty

    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 50 LeD...
  • Page 52 Distributed in U.S. by: Manufacturer: mectron S.p.a. via Loreto 15/A 850 Michigan Avenue columbus, ohio 43215 16042 Carasco (Ge) Italy Phone 614.459.4922 Tel. +39 0185 35361 Fax 614.459.4981 Fax +39 0185 351374 www.piezosurgery.us www.mectron.com e-mail: mectron@mectron.com e-mail: info@piezosurgery.us Reseller...

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