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 P2K USE AND MAINTENANCE MANUAL 0051...
  • Page 2 p2K...
  • 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

    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 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

    • any and all attempts to tamper with...

  • Page 9: Safety Precautions

    INTRODuCTION page 14 of this manual; • unauthorized repairs in accordance with 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 page 17 of this manual; Safety Precautions WARNING: Contraindications. CAUTION: in the case that the end Do not use the device on patients who user, when operating in his or her own carry heart stimulators (Pace-makers) or...
  • Page 10 (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

    0051 YYYY-MM MANIPOLO ABLATORE 102000000 Bar Code MANIPOLO HIBC 128 03120016 ABLATORE Insert Tips Identification Data On each insert is laser-marked the name the insert itself (Reference 2), the MECTRON logo (Reference 3) and the lot number to which the insert 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 P2K 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 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 15 DELIvERY Figure 1 – List of components...

  • Page 16: Use

    Commands The description of the commands available for operating with compact piezo P2K, are available in the manual provided by the manufacturer of the dentist’s unit. Switching the Device On and Off To switch the compact piezo P2K on and off, refer to the manual provided by the manufacturer of the dentist’s unit. Safety Precautions Before and During Use WARNING: Before starting to operate WARNING: Treatments that require with the device, make sure of having stock irrigation. Always check operation of the material (handpiece, insert tips, wrenches) irrigation before and during use. Make sure available to use in case the device fails or to the fluid outflows from the insert tip. inconveniences. Do not use the device if the irrigation does not work or if the pump is defective.
  • Page 17 WARNING: Cleaning and sterilising WARNING: Breakage and wear-out of new or repaired instruments. all the new the insert tips. High frequency oscillations or repaired device accessories are not sterile. and wear-out may, in rare circumstances, lead At first use and after each treatment they to the breakage of the insert tip. must be cleaned and sterilized by carefully Deformed or otherwise damaged insert tips following the instructions in Chapter 6 on are susceptible to breakage during their use. page 17 these insert tips must never be used. If an insert tip breaks, check that none of its WARNING: Diamond coated insert tips fragments remain in the treated part and,...

  • Page 18: Instructions For Use

    (golden WARNING: Handle sharp-edged and surface), where present, is visibly worn, the pointed insert tips with particular care. During insert tip must be replaced. the use of a worn the tightening/untightening operations, the insert tip decreases its efficiency. sharp-edged/pointed parts of the insert tip When the nitride coating wears out, the could cause harm. cutting efficiency decreases; re-sharpening the insert tip damages it and is therefore forbidden. Check that the insert tip is not...
  • Page 19 Place the insert tip inside the MECTRON torque wrench as illustrated in the figure. Firmly grip the body of the handpiece; CAUTION: Do not grab the handpiece by the terminal 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 wrench clockwise until it engages the clutch (the outer body of the wrench rotates with respect to the body of the handpiece producing mechanical sounds).

  • Page 20: Important Information On The Insert Tips

    • Use original mectron insert tips only. Use vibrate. of non-original insert tips, in addition • in the treatment of endodontic root to voiding the warranty, damages the...

  • Page 21: Disassembling Of Parts For Cleaning And Sterilization

    DISASSEMBLING O F P ARTS F OR C LEANING A ND S TERILIzATION pushing it deeper. Do not apply pressure or otherwise damaged insert tips are to the insert in the axial direction. susceptible to breakage during their use. these insert tips must never be used. •...
  • Page 22 CAUTION: Do not attempt to unscrew or turn the connector when disconnecting the handpiece. the connector could get damaged. Unscrew the nose cone of the handpiece.

  • Page 23: Cleaning And Sterilization

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

  • Page 24: Required Materials

    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

    Hold the handpiece with its front end pointed downward; Rinse thoroughly the front end and the surfaces of the external body of the handpiece under running warm tap water to eliminate any residual detergent;...
  • 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 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 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 Repeat the checks on the other accessories (insert tips, insert tip torque wrenches ), repeating the cleaning cycle if necessary.

  • 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. Dry all parts of the scaler handpiece and the scaler front tip well, in particular the electric contacts by blowing compressed air;...

  • Page 34: Sterilization

    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: Sterilization Method

    CLEANING AND STERILIzATION Seal the scaler handpiece (without insert tips) and the scaler nose cone individually, separately in disposable sterilization pouches. 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. 6.4.2 Sterilization Method WARNING: Infection control - CAUTION: DO NOT sterilize the foot Sterilisable parts. thoroughly remove all pedal. Foot pedal will no longer function.
  • Page 36 DO NOT ensure the sterilisation process validated by mectron adequate sterilization of the lumens, cavities, S.p.A., in a pre-vacuum autoclave, guarantees recessed features of the instruments. a SaL 10 by setting the parameters indicated...

  • 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

    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 P2K. 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 P2K 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

    9.1.2 Accessible Parts of the Casing compact piezo P2K is designed to operate in the electromagnetic environment specified below. The customer or user of compact piezo P2K 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 P2K is designed to operate in the electromagnetic environment specified below. The customer or user of compact piezo P2K 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 ME EQuIPMENT and ME SYSTEMS that does not have voltage within the compact piezo P2K RATED voltage a surge protection device in the primary power circuit range. If the compact piezo P2K 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 P2K 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 P2K is designed to operate in the electromagnetic environment specified below. The customer or user of compact piezo P2K 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

    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 customer or user of compact piezo P2K 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 P2K is designed to operate in an electromagnetic environment in which radiated RF disturbances are under control. The customer or the user of compact piezo P2K can help prevent electromagnetic interference by ensuring a minimum distance between the mobile and portable RF (transmitters) communication devices and compact piezo P2K, as recommended, in relation to the maximum output power of radiocommunications equipment.

  • Page 46: Troubleshooting

    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 P2K 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 P2K 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 is tip not correctly the Mectron torque wrench tightened on the handpiece chapter 4.4 on page...

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

    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 p2K...
  • Page 52 Distributed in U.S. by: Manufacturer: mectron S.p.a. via Loreto 15/A 850 Michigan Avenue 16042 Carasco (Ge) Italy columbus, ohio 43215 Tel. +39 0185 35361 Phone 614.459.4922 Fax +39 0185 351374 Fax 614.459.4981 www.mectron.com www.piezosurgery.us e-mail: mectron@mectron.com e-mail: info@piezosurgery.us Reseller...

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