mectron COMPACT PIEZO P2K Use And Maintenance Manual
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mectron COMPACT PIEZO P2K Use And Maintenance Manual

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COMPACT PIEZO P2K
USE AND MAINTENANCE MANUAL
0051

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Summary of Contents for mectron COMPACT PIEZO P2K

  • Page 1 COMPACT PIEZO P2K USE AND MAINTENANCE MANUAL 0051...
  • Page 2 COMPACT PIEZO P2K...
  • Page 3 Copyright © Mectron S.p.A. 2021. All rights reserved. No part of this document may be reproduced, in any form whatsoever, without the prior written consent of the copyright holder.

  • Page 4: Table Of Contents

    COMPACT PIEZO P2K CONTENTS Introduction Intended Use Description of the Appliance 1.2.1 Eligible Patient Group 1.2.2 Patient Selection Criteria 1.2.3 Indications for Use 1.2.4 Users Disclaimer Safety Requirements Symbols Identification Data 2.1 Scaler Handpiece Identification Data 2.2 Inserts Identification Data Delivery List of components Controls 4.2...
  • Page 5 9.1.4 Specifications of the tests for the Immunity of the Accessible Parts of the Casing to the Wireless RF Communications Device Troubleshooting 10.1 Quick Troubleshooting 10.2 Shipping to an Authorised Mectron Service Centre Warranty...
  • Page 6 COMPACT PIEZO P2K PAGE LEFT INTENTIONALLY BLANK...

  • Page 7: Introduction

    The Mectron piezoelectric ultrasonic scaler devices can be used on patients of any age and gender requiring a tooth polishing treatment. There are no contraindications for specific population segments. WARNING: The appliance must be used...

  • Page 8: Description Of The Appliance

    Failure to observe this regulation can cause serious injury to the patient, the operator, and damage/failure of the device. Description of the Appliance COMPACT PIEZO P2K is a multi-purpose levels. piezoelectric ultrasonic scaler. The appliance is equipped with an automatic It is designed to equip the operator with a...

  • Page 9: Users

    The manufacturer MECTRON cannot be held • Use of non original MECTRON inserts liable, expressly or implicitly, for any type of resulting in permanent damage to the personal injury and/or property damage,...

  • Page 10: Safety Requirements

    An electrosurgical scalpel or other and the relevant requirements of electrical electrosurgical units positioned near the safety. COMPACT PIEZO P2K appliance may interfere with the correct operation of the appliance WARNING: Cleaning and sterilising itself. new or repaired instruments. All the new or repaired appliance accessories are not sterile.
  • Page 11 The state of wear of the most common inserts (S1, S1-S, S2, S5, P2, P4, P10) can be WARNING: Exclusively use original checked using the supplied INSERT-CARD. To MECTRON inserts, accessories and spare use the INSERT-CARD correctly: parts. • Position the insert on the INSERT-CARD CAUTION: No modification is allowed to so that the profile corresponds to the this appliance.

  • Page 12: Symbols

    COMPACT PIEZO P2K Symbols Symbol Description Symbol Description Device compliant Nemko brand with Regulation (EU) Compliance with UL - 2017/745. Notified 0051 CSA regulations body: IMQ S.p.A. Caution! Read the Medical device instructions for use Operating instructions Manufacturer Date of manufacture...

  • Page 13: Identification Data

    Always provide this information every time the After Sales Service to provide fast and that you contact MECTRON After Sales Service. Scaler Handpiece Identification Data The handpiece name, MECTRON logo, MANIPOLO serial number, product code, HIBC matrix...

  • Page 14: Delivery

    DELIVERY List of components Figure 1 on page 11. can be ordered separately (see Table 4 on COMPACT PIEZO P2K is supplied with the page 11). standard equipment (see Table 2 on page NOTE: Both the items included in the 8), a set of variable accessories depending...
  • Page 15 DelIveRY Accessories available for order with standard supply Item Code Description Ref. 03570004 “ICS” series reusable base insert 03590009 "IC1" tip 02900112 IC1 tips kit (5 pcs.) DB1 reusable base support for 03570001 inserts 03590001 TA12D60 diamond insert 03590004 TA12D90 diamond insert 03590002 TA14D60 diamond insert 03590005 TA14D90 diamond insert 03590007...
  • Page 16 COMPACT PIEZO P2K Accessories available for order with standard supply Item Code Description Ref. 01560022 Layout A 01560023 Layout B 01560024 Layout C 01560026 Layout D Wiring 01560027 Layout E 01560031 Layout F 01560101 Layout G 01560141 Layout H 02150174 IT version 02150175 EN version Use and Maintenance Manual...
  • Page 17 Keep the packaging in case any items need to storage must be carried out with particular be sent to an Authorised MECTRON Service care. Centre and to store the appliance during long All the material sent by MECTRON was periods of non-use.

  • Page 18: Use

    WARNING: Contraindications. Do not the electronic circuit is able to recognise use COMPACT PIEZO P2K on patients with the best point of resonance of the insert Pacemakers or other implantable electronic without interference, thus allowing optimum devices.
  • Page 19 If the layer of titanium nitride (gold-plated WARNING: Insert Breakage and Wear. surface), where present, is visibly worn, the High frequency oscillations and wear can, in insert must be replaced. The use of a worn rare cases, lead to the breakage of the insert. insert reduces its efficiency.

  • Page 20: Instructions For Use

    Check that the electrical contacts of both are perfectly dry and if necessary dry them by blowing with compressed air. Screw in the preselected insert on the scaler handpiece until it comes into contact Place the insert inside the MECTRON torque wrench as shown in the figure.
  • Page 21 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.

  • Page 22: Important Information On The Inserts

    Do not block them • Use only original Mectron inserts. The against the tissues so as not to cause use of non-original inserts will void the their overheating.

  • Page 23: Disassembling Parts For Cleaning And Sterilisation

    Always switch the appliance off using the disconnect all accessories and components of switch and disconnect the power supply the COMPACT PIEZO P2K. cable from the wall socket and machine core unit before carrying out cleaning and sterilisation tasks. If present, remove the insert from the handpiece using the torque wrench;...
  • Page 24 COMPACT PIEZO P2K 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.

  • Page 25: Cleaning And Sterilisation

    The end of the service life of the accessories is generally determined by wear or damage resulting from use. Mectron guarantees the integrity of its scaler handpieces for up to 250 reconditioning cycles. Cleaning the Sterilisable Accessories NOTE: The cleaning procedures must be ) and then sterilisation ( Chapter 6.4 on...

  • Page 26: Scaler Handpiece

    COMPACT PIEZO P2K and/or phenols CAUTION: DO NOT USE as disinfectants:: • Acetone; • Very alkaline products (pH > 9); • Methylethylketone; • Products containing sodium hypochlorite; since they may discolour and/or damage the plastic materials. • Products containing hydrogen peroxide; The manufacturer disclaims all liability for any •...

  • Page 27: Inserts

    CLEANING AND STERILISATION Gently clean the surface of the scaler handpiece using the enzymatic detergent solution, with soft nylon bristle brush, with particular care in the areas: • thread of the scaler handpiece; • titanium shaft; • external and internal parts of nose cone.
  • Page 28 COMPACT PIEZO P2K Leave to soak for 10 minutes at 40°C ±2°C. This procedure reduces the amount of blood, protein and mucous present on the insert; During immersion in the enzymatic solution, delicately brush the surface of the insert using the brush with soft nylon bristles to eliminate all traces of visible dirt. Thoroughly clean the difficult areas...
  • Page 29 CLEANING AND STERILISATION Rinse the cavity of the insert with demineralised water injected under pressure (3.8 bar) for at least 10 seconds to eliminate all detergent residue; Place the insert in the ultrasonic tank immersed in the enzymatic detergent solution at 40 °C ±2 °C for at least 10 minutes;...

  • Page 30: Inserts Tightening Wrench

    COMPACT PIEZO P2K Rinse the internal channel of the insert with demineralised water injected under pressure (3.8 bar) for at least 10 seconds to eliminate all residue. Process validated by independent bodies with enzymatic detergent. 6.1.1.4 Inserts Tightening Wrench Place the torque wrench in a clean container, in a horizontal position.

  • Page 31: Automatic Cleaning

    CLEANING AND STERILISATION Remove the torque wrench from the enzymatic detergent solution. Thoroughly rinse and brush all the surfaces of the torque wrench (see previous point) under running water for at least 10 minutes; Place the torque wrench in the ultrasonic tank immersed enzymatic...
  • Page 32 COMPACT PIEZO P2K WARNING: On completion of the CAUTION: Owing to its conformation, the cleaning cycle in the thermal-disinfector, scaler handpiece can rotate. When not in use, the scaler handpiece remains at the wash the scaler handpiece must always be placed temperature for a long time.

  • Page 33: Cleaning Check

    CLEANING AND STERILISATION Cleaning Check 6.2.1 Required Materials • Light source; • 2.5X Magnifier. Once the cleaning operations have been completed, check the scaler handpiece and scaler nose cone under an adequate source of light, if necessary using a magnifying glass 2.5X, paying attention to any parts that may conceal soil residue (threading, cavities, grooves) and, if need be, repeat the cleaning cycle if soil is still...

  • Page 34: Drying And Lubrication

    COMPACT PIEZO P2K Drying and Lubrication 6.3.1 Required Materials • Compressed air; • Medical grade lubricant. • Soft, low-lint cloth; Thoroughly dry all parts of the scaler handpiece and scaler nose cone, in particular the electrical contacts by blowing compressed air; CAUTION: The scaler handpiece...

  • Page 35: Sterilisation

    CLEANING AND STERILISATION Dry the inserts tightening wrench using a soft, low-lint cloth; Lubricate the inserts tightening wrench with medical-grade lubricants in the indicated point. CAUTION: Do not use oil or silicone- based lubricants. Sterilisation 6.4.1 Preparation Seal the scaler handpiece (without inserts) and the scaler nose cone individually and separately in disposable sterilisation bags.

  • Page 36: Sterilisation Method

    CAUTION: Use sterilisation bags WARNING: Infection control - compliant with standard UNI eN ISO 11607-1. Sterilisable parts. Thoroughly remove all The sterilisation process validated by Mectron residual organic matter before sterilisation. S.p.A., in an autoclave with steam, guarantees CAUTION: Carry out the sterilisation by a SAL 10...

  • Page 37: Special Information

    If the material is METHODS AND PRECAUTIONS FOR DISPOSAL WARNING: Hospital waste. Treat the COMPACT PIEZO P2K must be disposed of and following objects as hospital waste: treated as waste subject to separate collection. Failure to comply with the previous points can •...

  • Page 38: Technical Data

    Device compliant with Class lla Regulation (EU) 2017/745 The class definition is determined by the manufacturer of the dental unit which incorporates COMPACT PIEZO P2K. Classification under the IEC/EN 60601-1 Parts applied: type B (insert) IP 20 (appliance) IP according to indications provided by the manufacturer of the dental unit...

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

    Guide and Manufacturer’s Declaration - Electromagnetic Emissions COMPACT PIeZO P2K is designed to operate in the electromagnetic environment specified below. The purchaser or user of COMPACT PIEZO P2K should ensure that it is used in such an environment. Emissions Test Compliance...

  • Page 40: Accessible Parts Of The Casing

    COMPACT PIEZO P2K 9.1.2 Accessible Parts of the Casing COMPACT PIeZO P2K is designed to operate in the electromagnetic environment specified below. The purchaser or user of COMPACT PIEZO P2K should ensure that it is used in such an environment. Essential EMC Electromagnetic Phenomenon standard or test...

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

    Guide and the Manufacturer's Declaration - Electromagnetic Immunity 9.1.3.1 Power Connection BC Input COMPACT PIeZO P2K is designed to operate in the electromagnetic environment specified below. The purchaser or user of COMPACT PIEZO P2K should ensure that it is used in such an environment. Essential EMC Electromagnetic Phenomenon standard or test...
  • Page 42 (common mode) and at ± 1 kV between line(s) voltage values. and line(s) (differential mode). b) During the test, all COMPACT PIEZO P2K cables must k) Not applicable to CLASS II devices and systems. be connected. l) It is necessary to use direct coupling.

  • Page 43: Points Of Contact With The Patient

    TECHNICAL DATA 9.1.3.2 Points of Contact with the Patient COMPACT PIeZO P2K is designed to operate in the electromagnetic environment specified below. The purchaser or user of COMPACT PIEZO P2K should ensure that it is used in such an environment. Essential EMC Electromagnetic Phenomenon standard or test Immunity test values...

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

    COMPACT PIEZO P2K 9.1.3.3 Parts Accessible to the Input / Output Signals COMPACT PIeZO P2K is designed to operate in the electromagnetic environment specified below. The purchaser or user of COMPACT PIEZO P2K should ensure that it is used in such an environment. Essential EMC Electromagnetic Phenomenon standard or test...
  • Page 45 Parts of the Casing to the Wireless RF Communications Device COMPACT PIEZO P2K is designed to operate in an electromagnetic environment in which radiated RF disturbances are under control. The purchaser or operator of COMPACT PIEZO P2K can help prevent electromagnetic interferences by guaranteeing a minimum distance between the mobile and portable RF communication devices (transmitters) and COMPACT PIEZO P2K, as recommended below, in relation to the maximum output power of the radio communication devices.
  • Page 46 WARNING: Portable RF communication level, the distance between the transmitter equipment (including peripheral devices such antenna and COMPACT PIEZO P2K can be as antenna cables and external antennas) reduced to 1 m. The test distance of 1 m is must not be used closer than 30 cm to any allowed by IEC 61000-4-3.
  • Page 47 Unscrew the insert and screw The insert is not correctly it back in correctly using the tightened on the handpiece Mectron torque wrench (See Poor performance Chapter 4.4 on page 14 Insert broken, worn or Replace the insert with a...
  • Page 48 • Product name; Clean and sterilise all parts that need to be • Serial number and/or batch number; sent to an Authorised Mectron Service Centre, following the instructions in Chapter 6 on • Reason for return / description of failure;...
  • Page 49 Mectron provides warranty the appliance and cause injury to the COMPACT PIEZO P2K, purchased new from patient. a Mectron dealer or importer, which covers • Accidental breakage during transport. defects in material and workmanship for a •...
  • Page 50 In order to avail of the warranty service, the client must return the appliance, at their own expense, to the MECTRON dealer/importer from which they purchased the product. The appliance must be returned together with the original packaging, accompanied by all the accessories and by a form containing: •...
  • Page 52 Manufacturer: Mectron S.p.A. Via Loreto 15/A 16042 Carasco (Ge) Italy Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com e-mail: mectron@mectron.com Rivenditore - Reseller - Revendeur - Revendedor - Wiederverkäufer - Återförsäljare...

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