MICROPIEZO Use and Maintenance Manual Rev 07

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Figura 1 – Componenti / Components / Composants

MANUALE D’USO E MANUTENZIONE

MICROPIEZO

MICROPIEZO

PAGINA LASCIATA INTENZIONALMENTE BIANCA

IV

USE AND MAINTENANCE MANUAL

MICROPIEZO

MICROPIEZO

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Figure 1 – Components

 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.

I

MICROPIEZO CONTENTS

1

Introduction

2

Identification Data

8

3

Delivery

9

4

Installation

13

5

Use

17

6 7 8

Long Flush function Disassembling Parts for Cleaning and Sterilisation Cleaning and Sterilisation

31 33 35

1.1 1.2 1.2.1 1.2.2 1.2.3 1.2.4 1.3 1.4 1.5 2.1 2.2 2.3 3.1 4.1 4.2 4.3 5.1 5.2 5.2.1 5.2.1.1 5.2.2 5.2.3 5.2.3.1 5.2.3.2 5.2.3.3 5.2.4 5.2.5 5.2.5.1 5.2.5.2 5.2.5.3 5.2.5.4 5.2.6 5.3 5.4 5.5

8.1 8.2 8.2.1 8.2.2 8.3 8.3.1 8.3.2

II

Intended Use Description of the Appliance Eligible Patient Group Patient Selection Criteria Indications for Use Users Disclaimer Safety Requirements Symbols Appliance ID Plate Handpiece Identification Data Inserts Identification Data List of Components

First Installation Safety Requirements in the Installation Phase Connecting Accessories Power On/Off Description of the Keyboard Functions and Power Levels of the Treatment Soft Mode Water Delivery Filling and Cleaning the Water Circuit FLUSH - Short Mode FLUSH - Long Mode FLUSH - Interruption Light Wi-Fi - IoT Technology Connection to a Wi-Fi Network Wi-Fi Network Requirements Communication Diagram Software Update Reports Safety Requirements Before and During Use Instructions for Use Important Information on the Inserts

Preparation Manual Cleaning with Enzymatic Detergent Required Materials Cleaning Method Manual Cleaning with Enzymatic Detergent and Running Water Preparation Required Materials

1

1 2 2 2 2 2 3 4 6 8 8 9 9

13 13 14 17 18 18 19 19 20 20 20 20 21 21 22 22 22 23 23 24 27 30

36 36 36 37 38 38 38

 8.3.3 8.4 8.4.1 8.4.2 8.5 8.5.1 8.5.1.1 8.5.1.2 8.5.1.3 8.5.1.4 8.5.2 8.5.2.1 8.5.2.2 8.6 8.6.1 8.6.2 8.7 8.7.1 8.7.2 8.8 8.8.1 8.8.2 8.8.2.1

Cleaning Method Disinfecting the Tank Irrigation Circuit Required Materials Procedure Cleaning the Sterilisable Accessories Manual Cleaning Required Materials Scaler Handpiece Inserts Inserts Tightening Wrench Automatic Cleaning Required Materials Cleaning Procedure Cleaning Control Required Materials Procedure for Cleaning Control Drying and Lubrication Required Materials Drying and Lubrication Procedure Sterilisation Preparation Sterilisation Method Special Information

38 40 40 40 45 45 45 46 49 51 53 53 54 55 55 55 56 56 56 57 57 58 58

9

Maintenance

59

10 11

Methods and Precautions for Disposal Technical Data

61 61

12

Troubleshooting

70

13

Warranty

77

9.1 11.1 11.2 11.2.1 11.2.2 11.2.3 11.2.3.1 11.2.3.2 11.2.3.3 11.2.4 12.1 12.2 12.3

Replacing the Peristaltic Pump

Software Electromagnetic Compatibility IEC/EN 60601-1-2 Guide and Manufacturer’s Declaration - Electromagnetic Emissions Accessible Parts of the Casing Guide and the Manufacturer's Declaration - Electromagnetic Immunity Power Connection BC Input Points of Contact with the Patient Parts Accessible to the Input / Output Signals Specifications of the Tests for the Immunity of the Accessible Parts of the Casing to the Wireless RF Communications Device Diagnostic System and Symbols on the Keyboard Quick Troubleshooting Shipping to an Authorised MECTRON Service Centre

59

62 63 63 64 65 65 67 68 69

70 74 76

III

MICROPIEZO

PAGE INTENTIONALLY LEFT BLANK

IV

Introduction

1

INTRODUCTION

Carefully read this manual before proceeding with installation operations, use, maintenance or other intervention operations on the appliance. Always keep this manual at hand. Important: To avoid damages to persons or property, carefully read all the "Safety Requirements” sections in the manual. According to the degree of severity the safety requirements are classified with the following indications: WARNING: (Always referred to damage to persons) CAUTION: (Referring to possible damage to property) The aim of this manual is to make the operators aware of the safety regulations, installation procedures, instructions for proper

1.1

use and maintenance of the appliance and its accessories. Use of this manual for aims other than those strictly linked to the installation, use and maintenance of the appliance is prohibited. The information and illustrations in this manual were updated on the edition date shown on the last page. MECTRON is engaged in continuously updating its products with possible changes to the components of the apparatus. In case you encounter discrepancies between the descriptions found in this manual and the equipment in your possession you can: • • •

check for any available updates in the MANUALS section of the MECTRON website1; ask clarifications to Your Dealer;

contact MECTRON After Sales Service.

Intended Use

MICROPIEZO is a piezoelectric ultrasonic scaler. With the appropriate inserts it is possible to perform the following treatments: •

•

•

Scaling: all the procedures for the removal of deposits of bacterial plaque and supragingival, subgingivali and inter dental stones, and removal of stains; Periodontics: periodontal therapy for scaling and root-planing/debridement, including cleaning and irrigation of the periodontal pocket; Cleaning treatment of the implant surface;

•

•

Endodontics: all the treatments for preparation of the channels, irrigation, filling, condensation of gutta-percha, endodontic reprocessing and retrograde preparation; Restorative and prosthesis: preparation of the cavities and removal of caries, removal of the prosthesis and of restoration materials in excess, condensation of the amalgam, finishing of the prosthetic stump.

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 in a dental practice or clinic, or in professional oral hygiene and preventive care centres. Do not use the device in environments where the atmosphere is saturated with flammable gases (anaesthetic mixtures, oxygen, etc.). 1

WARNING: Qualified and specialised staff. The appliance is intended exclusively for use by a dental surgeon, dentist, or dental hygienist, with suitable medical/health training.

http://mectron.it/en/technical-support/users-manuals/

1

MICROPIEZO WARNING: Intended use. Use the appliance exclusively for the use for which it is intended. Failure to observe this regulation can cause serious injury to the patient, the operator and damage/faults on the device.

1.2

Description of the Appliance

MICROPIEZO is a multi-purpose piezoelectric ultrasonic scaler designed to equip the operator with a product featuring an innovative design and unique technical characteristics, and to ensure patient comfort during treatment. The user interface is optimised to make all functions immediately available, by

1.2.1

integrating them into the touch keyboard. The handpiece is equipped with a circular LED light and is autoclavable at 135°C. The appliance is equipped with an automatic tuning circuit that optimises power and frequency for each insert available, in order to always operate in conditions of maximum efficiency.

Eligible Patient Group

This medical device is designed to be used with the following patient groups: •

Children;

•

Adults;

• •

Adolescents;

This medical device can be used on patients of any age, weight, height, gender, and nationality, where applicable.

Seniors.

1.2.2

Patient Selection Criteria

It is not recommended to use the device in the following cases: 1.

Patients with active implantable medical devices (for example: pacemakers, hearing aids, and/or other electromagnetic prostheses) without prior authorisation from their doctor;

1.2.3

Indications for Use

1.2.4

Users

2.

Patients with clinical conditions not suitable for treatment of the sites (for example: local anaesthesia).

All piezoelectric ultrasonic scaler device models are intended for professional use only. The user is therefore the only person able to decide if and how to treat their patients.

Use of the device is suitable for all eligible patients (see Chapter 1.2.1 on page 2) whose doctor has prescribed professional scaling, periodontology, endodontic cleaning, implant site surface cleaning, a restorative or prosthetic technique, as part of the intended use of the device (see Chapter 1.1 on page 1). The device must be used exclusively by specialised and properly trained personnel, specifically the dental surgeon/dentist or dental hygienist, who must be able-bodied, adult, of any weight, age, height, gender, and nationality.

2

Introduction 1.3

Disclaimer

The manufacturer MECTRON disclaims all liability, express or implied, and cannot be held responsible for direct or indirect personal injury and/or property damage, occurring as a result of incorrect procedures linked to the use of the appliance and its accessories. The manufacturer MECTRON cannot be held liable, expressly or implicitly, for any type of personal injury and/or property damage, inflicted by the user of the product and its accessories and which occurs in the following cases, by way of example and not of limitation: • •

• •

•

•

Misuse or use during procedures other than those specified in the destination of use of the product; The environmental conditions for preservation and storage of the device are not complying with the requirements indicated in Chapter 11 on page 61; The appliance is not used in accordance with all the instructions and requirements described in this manual;

The electrical system of the places where the equipment is used do not comply with the laws in force and the related regulations;

Assembly operations, extensions, readjustments, upgrades and repairs of the device are carried out by personnel not authorised by MECTRON; Misuse, abuse, abnormal use, negligent use, intentional misconduct or use exceeding the limits of the appliance

• •

•

• • • • •

indicated and allowed and/or normal wear or deterioration, ill-treatment and/ or incorrect interventions;

Any attempt to tamper with or modification of the appliance under every circumstance;

Use of non original MECTRON inserts resulting in permanent damage to the thread of the handpiece with impaired functioning and risk of injury to the patient;

Use of non original MECTRON inserts used in accordance with the settings designed and tested on the original MECTRON inserts. Correct use of the settings is only guaranteed with original MECTRON inserts;

Shortage of stock material (handpiece, inserts, wrenches) to be used in case of a standstill due to faults or problems; Incorrect/omitted maintenance compared to what is stated in Chapter 9 on page 59 of this manual; Breach of the requirements and the information contained in Chapter 5.5 on page 30 of this manual; Breach of the requirements and the information contained in Chapter 8 on page 35 of this manual;

Unauthorised repairs in accordance with the indications contained in Chapter 12.3 on page 76 this manual.

3

MICROPIEZO 1.4

Safety Requirements

WARNING: Contraindications. Do not use the appliance on patients with Pacemakers or other implantable electronic devices. This regulation also stands for the operator. WARNING: Contraindications. Do not perform scaling treatments without water spray in order to avoid an overheating of the insert that can cause damage to the tooth. Treatments without water spray can only be those performed with the "Dry Work" inserts without water passage. CAUTION: Contraindications. Ultrasonic scaler. Do not perform treatments on metal or ceramic prosthetics. Ultrasonic vibrations could lead to decementation of the dentures. WARNING: Contraindications. Interference from other equipment. An electrosurgical scalpel or other electrosurgical units positioned near the MICROPIEZO appliance may interfere with the correct operation of the appliance itself. WARNING: Contraindications. Interference with other equipment. Even if compliant with standard IEC 60601-1-2, MICROPIEZO may interfere with other devices in the vicinity. MICROPIEZO must not be used near or stacked with other appliances. However, if this should become necessary, it is necessary to check and monitor the correct functioning of the appliance in that configuration. WARNING: Risk of explosion. The appliance cannot operate in environments where the atmosphere is saturated with flammable gases (aesthetic mixtures, oxygen, etc.).

4

CAUTION: In case the final user, operating in their own medical room or surgery, in order to comply with mandatory requirements, must periodically inspect the equipment present in the surgery, the test procedures to apply to medical electrical equipment and medical electrical systems for the safety assessment must be carried out following the standard EN 62353 'Medical electrical equipment - Periodic inspections and tests to be carried out after repair of medical electrical equipment'. The frequency of periodic inspections in the intended conditions of use described in this “Use and Maintenance” manual is once per year or every 2000 hours of use, whichever condition is satisfied first. WARNING: Checking the condition of the device before treatment. Always check that there is no water under the appliance. Before every treatment always check the perfect operation of the appliance and efficiency of the accessories. If operation anomalies are observed do not carry out the treatment. If the faults concern the appliance, contact an Authorised MECTRON Service Centre. CAUTION: The electrical system of the premises in which the appliance is installed and used must comply with the rules in force and the relevant requirements of electrical safety. CAUTION: To avoid the risk of electrical shocks, this appliance has to be connected exclusively to a power supply with an earth safety device. WARNING: Cleaning and sterilising new or repaired instruments. All the new or repaired appliance accessories are not sterile. At first use and after each treatment they must be cleaned and sterilised by carefully following the instructions in Chapter 8 on page 35.

Introduction WARNING: Infection control. For maximum patient and operator safety, before using all the parts and reusable accessories, make sure they have been previously cleaned and sterilised by following the instructions in Chapter 8 on page 35. CAUTION: Contraindications. After having autoclaved the handpiece, inserts, torque wrench or any other sterilisable accessory, wait for them to completely cool down before reusing them. WARNING: Insert Breakage and Wear. High frequency oscillations and wear can, in rare cases, lead to the breakage of the insert. Deformed or damaged inserts are susceptible to breakage during use. Broken or worn inserts must not ever be used. In the event of breakage check that no fragments remain in the treated part and at the same time use suction effectively to remove them. It is necessary to instruct the patient to breathe through the nose during the treatment, or use a dental dam, so as to avoid to ingest fragments of broken inserts. Check the state of wear of the insert and its integrity before and during each use. If a drop in performance occurs, see to its replacement. The state of wear of the most common inserts (S1, S1-S, S2, S5, P2, P4, P10) can be checked using the supplied INSERT-CARD. To use the INSERT-CARD correctly: •

Position the insert on the INSERT-CARD so that the profile corresponds to the one printed on the card. The printed profile on the card has a red line

•

indicating the limit of wear;

If the insert is shorter than the limit of wear, its performance will be significantly inferior compared to that of a new insert, and should therefore be replaced.

If the layer of titanium nitride (gold-plated surface), where present, is visibly worn, the insert must be replaced. The use of a worn insert reduces its efficiency. Diamond Inserts: diamond inserts must be replaced when the layer of titanium nitride is visibly worn and in any case after a maximum of 10 treatments. When the nitriding is consumed, the cutting edge loses effectiveness; a possible regrinding harms the insert, therefore it is prohibited. Verify that the insert is not worn. During the operation frequently check that the insert is intact, especially in the apical part. During the operation avoid prolonged contact with the retractor or with metal instruments in use. Do not exert excessive pressure on the inserts during use. WARNING: Exclusively use original MECTRON inserts, accessories and spare parts. CAUTION: No modification is allowed to this appliance. WARNING: In case of an adverse event and/or accident attributable to the device during correct use and in accordance with the intended use, a report must be made to the Competent Authority and manufacturer indicated on the product label.

5

MICROPIEZO 1.5

Symbols Symbol

0051

Description Device compliant with Regulation (EU) 2017/745. Notified body: IMQ S.p.A.

Symbol

Description Nemko brand Compliance with UL CSA regulations

Medical device

Caution! Read the instructions for use

Operating instructions

Manufacturer

Date of manufacture

Serial number

Batch number

Product code

Not sterile

The sterilisable materials must be autoclaved and can resist up to a maximum temperature of 135°C

“B” Part applied according to regulation EN 60601-1

Polarization of the connector.

-

Power button.

Connection of the control pedal

Class II appliance

For internal use only.

The appliance and its accessories must not be disposed of or treated as municipal solid waste

Generic warning sign a)

Temperature limits for transport and storage

Moisture limits for transport and storage

Atmospheric pressure limits for transport and storage

6

+

Continuous current

Alternating current

QTY.1

Quantity in package: 1

Introduction Symbol

Description

Symbol

Power level Water flow

IP 22

Protection degree of the case

Table 1 – Symbols

Description Soft Mode

IP 20

Protection degree of the case

Rx only

For US market only CAUTION: US federal law restricts sale to orders by licensed dentists or dental hygienists only.

a) The symbol is represented by a yellow triangle and black graphic symbol.

NOTE: For other symbols, refer to Chapter 12.1 on page 70.

7

MICROPIEZO

IDENTIFICATION DATA

A correct description of the model and of the serial number of the appliance will allow the After Sales Service to provide fast and

2.1

effective answers. Always provide this information every time that you contact MECTRON After Sales Service.

Appliance ID Plate

Each appliance is equipped with an identification plate indicating the main technical characteristics and serial number. The identification plate is located under the appliance. The complete technical specifications are provided in Chapter 11 on page 61.

MICROPIEZO 24V 1,5A AC/DC Adapter Model:

XP POWER ACM36US24W

04000122 113000000 YYYY-MM-DD

NOTE: The complete list of symbols is provided in Chapter 1.5 on page 6.

manufacturer Mectron S.p.A. Via Loreto 15/A 16042 Carasco -GE- Italy ESPRESSIF ESP32-WROOM-32D ANATEL: UL-BR 20.0178 SRRC: CMIIT ID: 2018DP2467 NCC: CCAH18LP0201T7 MIC: 211-171102 IC: 21098 ESPWROOM32D FCC ID: 2AC7Z-ESPWR00M32D

0051

made in Italy Rx Only

2

Bar Code HIBC 128

Additional symbols and characteristics of the device are provided on a separate plate. This identification plate is located under the appliance. NOTE: The complete list of symbols is provided in Chapter 1.5 on page 6.

Device for intermittent operation: 55 s ON - 30 s OFF with irrigation 30 s ON - 120 s OFF without irrigation

Handpiece Identification Data

The handpiece name, MECTRON logo, serial number, product code, HIBC barcode, and a series of symbols are laser engraved on the handpiece.

MANIPOLO ABLATORE SLIM

114000000

0476 0051

YYYY-MM

03120000

MANIPOLO ABLATORE SLIM

NOTE: The complete list of symbols is provided in Chapter 1.5 on page 6.

114000000 03120238

107000000

YYYY-MM

03120238

0476 YYYY-MM 0051

0476 0051

2.2

MICROPIEZO

MANIPOLO ABLATORE SLIM

114000000 03120238

8

0476 0051

Data Matrix HIBC 128

YYYY-MM

MANIPOLO ABLATORE SLIM

Delivery 2.3

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.

1

3

DELIVERY

3.1

List of Components

Refer to Figure 1 on the inside cover. MICROPIEZO is supplied with the standard equipment (see Table 2 on page 10), a set of variable accessories depending on the configuration and client requests (see Table

2

3

3 on page 11), and accessories that can be ordered separately (see Table 4 on page 12). NOTE: Both the items included in the standard supply and all accessories can be ordered separately by the client.

Standard supply Item Device core unit

Code

Description

Ref.

04000122

A

Irrigation tank complete with 02790128 cap

B

Pedal FS-11 with cord and plug

02900144

C

Power adapter

03160024

D

Scaler Handpiece

03120238

MANIPOLO ABLATORE SLIM (SLIM SCALER HANDPIECE)

E

9

MICROPIEZO Standard supply Item

Code

Use and Maintenance Manual Information: Documentation

Online

Description

02150403

IT/EN/FR version

02150404

ES/DE/SV version

Ref.

F

02150650

Table 2 – Standard supply. Accessories available for order with standard supply Item

Torque wrench

Inserts

10

Code

Description

02900137

K10 torque wrench b)

02900081

K7 torque wrench d) b)

0296xxxx

"S” series reusable scaler inserts b)

0308xxxx

“PE” series reusable scaler inserts b)

0305xxxx

“R” series reusable scaler inserts b)

0345xxxx

“ER” series reusable scaler inserts b)

0235xxxx

“E” series reusable scaler inserts b)

0299xxxx

“D” series reusable scaler inserts b)

0219xxxx

“CM” series reusable scaler inserts b)

03570004

“ICS” series reusable base insert b)

03590009

"IC1" tip b)

02900112

IC1 tips kit (5 pcs.) b)

03570001

DB1 reusable base support for inserts b)

03590001

TA12D60 diamond insert b)

Ref. G

H