mectron COMPACT PIEZO P2K Installation Manual
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mectron COMPACT PIEZO P2K Installation Manual

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COMPACT PIEZO P2K
INSTALLATION MANUAL
0051

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Summary of Contents for mectron COMPACT PIEZO P2K

  • Page 1 COMPACT PIEZO P2K INSTALLATION 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 Appliance ID Plate 2.2 Scaler Handpiece Identification Data 2.3 Inserts Identification Data Delivery List of Components...
  • Page 5 7.1 Electromagnetic Compatibility IEC/EN 60601-1-2 7.1.1 Guide and Manufacturer’s Declaration - Electromagnetic Emissions 7.1.2 Accessible Parts of the Casing 7.1.3 Guide and the Manufacturer's Declaration - Electromagnetic Immunity 7.1.3.1 Power Connection BC Input 7.1.3.2 Points of Contact with the Patient 7.1.3.3 Parts Accessible to the Input / Output Signals 7.1.4 Specifications of the Tests for the Immunity of the Accessible Parts of the Casing to the Wireless RF Communications Device Troubleshooting Quick Troubleshooting 8.2 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

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

  • Page 10: Safety Requirements

    An electrosurgical scalpel or other At first use and after each treatment they electrosurgical units positioned near the must be cleaned and sterilised by carefully COMPACT PIEZO P2K appliance may interfere following the instructions in Chapter 6 on with the correct operation of the appliance page 19 of the Use and Maintenance itself.

  • Page 11: Symbols

    INTRODUCTION 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 Serial number Batch number Product code The sterilisable...

  • Page 12: Identification Data

    Mectron S.p.A. Via Loreto 15/a number. The ID plate is located on the 16042 Carasco -GE- Italy COMPACT PIEZO P2K side of the COMPACT PIEZO P2K module. 50/60 Hz / 32V Min. 40 VA The complete technical specifications are 04000079 YYYY-MM-DD provided in...

  • Page 13: Scaler Handpiece Identification Data

    Chapter 1.5 on page 5 03120016 0051 YYYY-MM SCALER ABLATORE 102000000 Bar Code SCALER HIBC 128 03120016 HANDPIECE Inserts Identification Data The name of the insert itself (Reference 1), MECTRON logo (Reference 2), and insert batch number (Reference 3) are laser engraved on each insert.

  • 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 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 TA14D120 diamond insert 03590003 TA16D60 diamond insert...
  • 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: Installation

    The dental unit to which COMPACT PIEZO P2K essential performance. is connected must be a medical device that complies with general and applicable product CAUTION: Check that the dental unit to...

  • Page 19: Mechanical Installation

    Figure 2 – Dimensions of the module. Electrical Connections COMPACT PIEZO P2K allows various electrical electrical connections, configurations to satisfy the characteristics of COMPACT PIEZO P2K device is equipped with the dental unit in which it is housed. 2 connectors (see Figure 3 on page 14): dental units which •...
  • Page 20 COMPACT PIEZO P2K 16 15 14 13 12 11 10 9 Figure 3 – Module connectors. M1 Connector Pin-Out Pin Signal Signal Reserved Bypass capacity Pedal + Power Selection Valve AC In Power Control AC/DC In Pedal - +Vdc Reserved Table 5 – M1 Connector Pin-Out.

  • Page 21: Alternate 24V Power Supply

    INSTALLATION 4.3.1 Alternate 24V Power Supply To power the module at 24V~ 50/60 Hz connect pins 13 and 14 (see Figure 3 on page 14 and Table 5 on page 14). Connect pins 8 and 9 to insert the bypass capacity present on the board to filter any disturbances on the power supply. Observe the voltage and current values indicated on the plate. 4.3.2 Direct 32V Power Supply To power the module at 32V connect the power supply positive on pin 14 and...

  • Page 22: Power Regulation With 10 Kohm Potentiometer

    COMPACT PIEZO P2K 4.3.3.2 Power Regulation with 10 kOhm Potentiometer Connect the 10 kOhm potentiometer between pins 6 and 10 and a 20 kOhm, 10 kOhm linear 1/8W, 1% resistance between pins 12 and potentiometer The maximum power corresponds to resistance 0. 20 kOhm 1/8W, 1% resistance 4.3.3.3 Power Regulation with 4.7 kOhm Potentiometer Connect the 4.7 kOhm potentiometer between pins 6 and 10 and a 39 kOhm, 4.7 kOhm linear...

  • Page 23: Power Regulation

    12 and 10. 0-10V 1mA 10 kOhm 1/8W, 1% resistance 4.3.4 Solenoid Valve Control The COMPACT PIEZO P2K provides an enabling in output for a solenoid valve Solenoid valve (optional) on the handpiece irrigation circuit. The 24V 2,5W output distributes 24V with maximum power 2.5W.

  • Page 24: Enabling Of Pedal With Positive Signal

    COMPACT PIEZO P2K 4.3.5.2 Enabling of Pedal with Positive Signal The pedal must be connected to pins 8 and 11. Pedal 4.3.6 Other Connections Pins 1 and 16 must always be connected to each other.

  • Page 25: Connecting The Cord Of The Scaler Handpiece

    Standard Connections facilitate installation NOTE*: Near the connection on the module COMPACT PIEZO P2K in the different types of it is advisable to wind the power line 3 times dental units, there are 7 available “standard” on a ferrite (see following chapters). The connection layouts, each equipped with a ferrite is not supplied standard.

  • Page 26: Layout A

    COMPACT PIEZO P2K 4.3.8.1 Layout A The power supply (24 V~ 50/60 Hz ±10% or 32 V ±10%) and consent are provided by the pedal. The power is regulated by a 2.2KΩ linear potentiometer (see Figure 5 on page 20). Fuse holder, fuse and pedal are not included in the Mectron supply 2.2 KΩ...

  • Page 27: Layout C

    Minimum 40VA Negative Fuse holder, fuse, instrument Solenoid valve tray and pedal are not (optional) included in the Mectron supply 24 V 2,5W maximum Scaler handpiece cord Green 8 7 6 5 4 3 2 1 Figure 7 – Layout C 4.3.8.4...

  • Page 28: Layout E

    COMPACT PIEZO P2K 4.3.8.5 Layout E The power supply (24 V~ 50/60 Hz ±10% or 32 V ±10%) and consent are provided by the pedal. The power is regulated by a 4.7KΩ linear potentiometer (see Figure 9 on page 22). Fuse holder, fuse and pedal are not included in the Mectron supply 2.2 KΩ linear...

  • Page 29: Layout G

    The power is regulated by a variable voltage between 0 and 5 V (see Figure 11 on page 23). Fuse holder, fuse and pedal are not included in the Mectron supply Power supply 24 Vac ± 10% 50/60 Hz Pedal...

  • Page 30: Water Connection

    COMPACT PIEZO P2K Water Connection The COMPACT PIEZO P2K requires a water and solenoid valve, be fitted with supply line to cool the handpiece and inserts a valve dedicated to supplying the during the operating cycle. COMPACT PIEZO P2K handpiece and The device is sold with a connecting cable...

  • Page 31: Diagnostics

    DIAGNOSTICS DIAGNOSTICS The appliance is equipped with an APC components, and a two-coloured diagnostic automatic protection circuit which LED (green and red), positioned on the board, activated when operating faults occur on the which indicates when the module is powered. Description of Diagnostic Warnings 5.1.1 Appliance Powered Without Pedal Consent...

  • Page 32: Methods And Precautions For Disposal

    • Inserts, when worn or broken; injuries. • Inserts tightening wrench, when worn or COMPACT PIEZO P2K must be disposed of and broken. treated as waste subject to separate collection. Disposable materials and materials that carry...

  • Page 33: Technical Data

    30 sec. ON - 120 sec. OFF without irrigation Power adapter compliant with IEC/EN 60601-1: Power Supply • 24 V~ 50/60 Hz or • 32 V Max. Power Consumption 40 VA Fuse T 2AL, 250V (not included in Mectron supply) Automatic Scan Working Frequency From 24 KHz to 36 KHz Adjustable depending type Power installation.

  • Page 34: 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...

  • Page 35: Accessible Parts Of The Casing

    TECHNICAL DATA 7.1.2 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 Immunity test values...

  • Page 36: Guide And The Manufacturer's Declaration - Electromagnetic Immunity

    Guide and the Manufacturer's Declaration - Electromagnetic Immunity 7.1.3.1 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 37 (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 38: Points Of Contact With The Patient

    COMPACT PIEZO P2K 7.1.3.2 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...

  • Page 39: Parts Accessible To The Input / Output Signals

    TECHNICAL DATA 7.1.3.3 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 Immunity test values...

  • Page 40: Specifications Of The Tests For The Immunity Of The Accessible Parts Of The Casing To The Wireless Rf Communications Device

    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 41: Troubleshooting

    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 42 COMPACT PIEZO P2K Problem Possible Cause Solution The insert is the type without Use an insert type with a a liquid passage liquid passage The Water function is not Activate the Water function active Unscrew the insert from the handpiece and release the...

  • Page 43: Shipping To An Authorised Mectron Service Centre

    • Details of owner and contact number; accessories. • 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 page • Reason for return / description of failure; of the Use and Maintenance Manual.

  • Page 44: Warranty

    • Damage due to incorrect use or Mectron provides warranty carelessness, or due to connection to a COMPACT PIEZO P2K, purchased new from voltage other than that envisaged. a Mectron dealer or importer, which covers • Expired warranty. defects in material and workmanship for a...
  • Page 45 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 48 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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