COMPACT PIEZO LED Use and Maintenance Manual Rev 08

USE AND MAINTENANCE MANUAL

COMPACT PIEZO LED

0051

COMPACT PIEZO LED

 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

COMPACT PIEZO LED CONTENTS

1

Introduction

2

Identification Data

7

3

Delivery

8

4

Use

12

5 6

Disassembling Parts for Cleaning and Sterilisation Cleaning and Sterilisation

17 19

7 8 9

Routine Maintenance Methods and Precautions for Disposal Technical Data

34 34 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 3.1 4.1 4.2 4.3 4.4 4.5 6.1 6.1.1 6.1.1.1 6.1.1.2 6.1.1.3 6.1.1.4 6.1.2 6.1.2.1 6.2 6.2.1 6.3 6.3.1 6.4 6.4.1 6.4.2 6.4.2.1

9.1 9.1.1 9.1.2 9.1.3 9.1.3.1 9.1.3.2 9.1.3.3

II

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

List of Components

Controls Power On/Off Safety Requirements Before and During Use Instructions for Use Important Information on the Inserts Cleaning the Sterilisable Accessories Manual Cleaning Required Materials Scaler Handpiece Inserts Inserts Tightening Wrench Automatic Cleaning Required Materials Cleaning Check Required Materials Drying and Lubrication Required Materials Sterilisation Preparation Sterilisation Method Special Information

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

1 1 2 2 2 2 2 3 4 6 7 7

8

12 12 12 14 16 19 20 20 20 23 27 28 28 30 30 31 31 32 32 33 34

36 36 37 38 38 40 41

 9.1.4

Specifications of the Tests for the Immunity of the Accessible Parts of the Casing to the Wireless RF Communications Device

42

10

Troubleshooting

43

11

Warranty

46

10.1 10.2

Quick Troubleshooting Shipping to an Authorised Mectron Service Centre

43 45

III

COMPACT PIEZO LED

PAGE LEFT INTENTIONALLY BLANK

IV

Introduction

1

INTRODUCTION

Carefully read this manual before proceeding with installation operations, use, maintenance or other intervention operations on the appliance. This manual must always be available to the operator. Important: To avoid damages to persons or property, carefully read all the "Safety Requirements" in the manual. Depending on the level 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, instal-

1.1

lation procedures, instructions for proper 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

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 treatments for canal preparation, irrigation, filling, guttapercha condensation, endodontic reprocessing and retrograde cavity 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.

https://manuals.mectron.com/

1

COMPACT PIEZO LED 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/failure of the device.

1.2

Description of the Appliance

COMPACT PIEZO LED is a multi-purpose piezoelectric ultrasonic scaler. It is designed to equip the operator with a product featuring an innovative design and unique technical characteristics, and to ensure utmost patient comfort during treatment thanks to a broad scale of available power levels. The appliance is equipped with an automat-

1.2.1

ic tuning circuit that optimises power and frequency for each insert available, in order to always operate in conditions of maximum efficiency. The handpiece is fitted with a 360° adjustable LED light and can be autoclaved at a maximum temperature of 135°C for a maximum period of 20 minutes.

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 9 on page 35; 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 7 on page 34 of this manual; Breach of the requirements and the information contained in Chapter 4.5 on page 16 of this manual; Breach of the requirements and the information contained in Chapter 6 on page 19 of this manual;

Unauthorised repairs in accordance with the indications contained in Chapter 10.2 on page 45 this manual.

3

COMPACT PIEZO LED 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 COMPACT PIEZO LED 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, COMPACT PIEZO LED may interfere with other devices in the vicinity. WARNING: Risk of explosion. The appliance cannot operate in environments where the atmosphere is saturated with flammable gases (aesthetic mixtures, oxygen, etc.).

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. 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. 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 6 on page 19. 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 6 on page 19. 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.

4

Introduction 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

COMPACT PIEZO LED 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

Hazardous voltage

Alternating current

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

Generic warning signal a)

Temperature limits for transport and storage Atmospheric pressure limits for transport and storage

Moisture limits for transport and storage

QTY.1

Quantity in package: 1

For US market only Rx only

Table 1 – Symbols

6

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.

Identification Data

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 effective answers.

Scaler Handpiece Identification Data

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

MANIPOLO ABLATORE SLIM

114000000

YYYY-MM

03120000

0476 0051

2.1

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

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

MANIPOLO ABLATORE SLIM

114000000 03120238 YYYY-MM

Data Matrix HIBC 128

2.2

0476 0051

MANIPOLO ABLATORE SLIM

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

2

3

7

COMPACT PIEZO LED

3

DELIVERY

3.1

List of Components

See Figure 1 on page 11. COMPACT PIEZO LED is supplied with the standard equipment (see Table 2 on page 8), a set of variable accessories depending on the configuration and client requests (see Table 3 on page 10), and accessories

that can be ordered separately (see Table 4 on page 10). NOTE: Both the items included in the standard supply and all accessories can be ordered separately by the client.

Standard supply Item

Code

Description

Ref.

Device core unit

04000091

A

Cord

02830086

B

Scaler Handpiece

03120238

MANIPOLO ABLATORE SLIM (SLIM SCALER HANDPIECE)

Use and Maintenance Manual

02150238

IT/EN/FR/DE/ES/SV version

Installation Manual

02150239

IT/EN/FR/DE/ES/SV version

Information: Online Documentation

02150650

C

D

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

Torque wrench

Inserts

Code 02900137

K10 torque wrench b)

02900081

K7 torque wrench c) b)

0296xxxx

"S” series reusable scaler inserts b)

0308xxxx 0305xxxx

8

Description

“PE” series reusable scaler inserts b)

“R” series reusable scaler inserts b)

Ref. E

F

Delivery Accessories available for order with standard supply Item

Code 0345xxxx 0235xxxx 0299xxxx

Description

Ref.

“ER” series reusable scaler inserts b)

“E” series reusable scaler inserts b) “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)

03590004

TA12D90 diamond insert b)

03590002

TA14D60 diamond insert b)

03590005

TA14D90 diamond insert b)

03590007

TA14D120 diamond insert b)

03590003

TA16D60 diamond insert b)

03590006

TA16D90 diamond insert b)

03590008

TA16D120 diamond insert b)

03590010

TF12D60 diamond insert b)

03590011

TF16D60 diamond insert b)

03590012

TF12D90 diamond insert b)

9

COMPACT PIEZO LED Accessories available for order with standard supply Item

Code

Wiring

Description

03590013

TF16D90 diamond insert b)

01560022

Layout A b)

01560023

Layout B b)

01560024

Layout C b)

01560026

Layout D b)

01560027

Layout E b)

01560031

Layout F b)

01560101

Layout G b)

01560141

Layout H b)

Ref.

G

Table 3 – Accessories available for order with standard supply. Accessories available for separate order Item

Code

Description

Ref.

Scaler Handpiece

03120142

MANIPOLO ABLATORE LED (LED SCALER HANDPIECE) b)

H

Front cone for LED handpiece

03020158

Front cone for LED SCALER HANDPIECE b)

I

Front cone without light

03020171

Front cone for LED SCALER HANDPIECE b)

J

Light guide kit

02900146

Front cone, light guide and decorative ring for SLIM scaler handpiece b)

K

Table 4 – Accessories available for separate order. b) Produced by Mectron.

10

c) To be used only for the "Crown Preparation” kit.

Delivery The packaging of the appliance cannot undergo strong impacts as contains electronic components, therefore the transport and the storage must be carried out with particular care. All the material sent by MECTRON was controlled at the time of dispatch. The appliance is shipped appropriately protected and packaged. Upon receipt of the appliance, check for any possible damage caused during transport and in case any damage and/or defects is found,

A

B

E

F

complain to the transporter. Keep the packaging in case any items need to be sent to an Authorised MECTRON Service Centre and to store the appliance during long periods of non-use. WARNING: Before starting the treatment, always make sure to have a stock of material (handpiece, inserts, wrenches) to use in the event of failures or drawbacks.

C

G

D

H

x3

I

J

K

Figure 1 – List of components

11

COMPACT PIEZO LED

4

USE

4.1

Controls

COMPACT PIEZO LED offers a very broad power range: from a subgingival perio treatment in soft mode to more aggressive scaling. The description of the available commands to control COMPACT PIEZO LED is available in the manual supplied by the manufacturer of the dental unit on which it is installed.

4.2

Power On/Off

To switch COMPACT PIEZO LED and the relative LED light positioned on the top of the handpiece on and off, consult the manual supplied by the manufacturer of the dental unit on which it is installed.

4.3

Safety Requirements Before and During Use

WARNING: Before starting work always ensure that you have all replacement parts (handpiece, inserts, keys) to use should there be downtime due to a fault or problem. WARNING: Exclusively use original Mectron inserts, accessories and replacement parts. WARNING: Use of non-original inserts not produced by MECTRON: this entails permanent damage to the thread of the handpiece and compromises correct operation with the risk of causing harm to the patient. CAUTION: Contraindications Ultrasonic Scaler. Do not perform treatments on metal or ceramic prosthetics. Ultrasonic vibrations could lead to decementation of the dentures. WARNING: Contraindications. Do not use COMPACT PIEZO LED on patients with Pacemakers or other implantable electronic devices. This regulation also stands for the operator. WARNING: 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.

12

CAUTION: In treatments requiring irrigation, use only inserts with a liquid passage. WARNING: Treatments that require irrigation. Always check the operation of the irrigation before and during use. Make sure that the liquid exits from the insert. Do not use the appliance if the irrigation does not work. WARNING: Infection control. First use: All parts and reusable accessories (new or returned from an Authorised MECTRON Service Centre) are delivered in NON-STERILE conditions and must be treated before each use, according to the instructions provided in Chapter 6 on page 19. Subsequent uses: After each treatment, clean and sterilise all parts and reusable accessories according to the instructions in Chapter 6 on page 19. CAUTION: For correct use of the appliance, the pedal must be pressed and the appliance started with the insert not in contact with the part to be treated, so that the electronic circuit is able to recognise the best point of resonance of the insert without interference, thus allowing optimum performance.

Use WARNING: Before each treatment ensure that the insert that is suitable for the treatment is inserted on the handpiece. Use only the Mectron torque wrench to secure the insert to the handpiece. WARNING: Do not change the insert whilst the handpiece is in operation in order to avoid causing injury to the operator. 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. CAUTION: Contraindications. After autoclaving the handpiece, the inserts, the torque wrench, or any other sterilisable accessory, wait until it has completely cooled before reuse. CAUTION: The electrical contacts inside the connectors on the handpiece and cord must be dry. Before connecting the handpiece to its cord, make sure that the electrical contacts of the connector on both sides are perfectly dry, especially after the sterilisation cycle in an autoclave. If necessary dry the contacts by blowing them with compressed air. CAUTION: Owing to its conformation, the handpiece can rotate. When not used the handpiece must always be put back on its support stand. WARNING: During the intervention on the patient, do not perform any maintenance tasks on the system. WARNING: Infection control. After prolonged non-use of the dental unit, run a water circuit cleaning cycle as indicated in the user manual supplied by the manufacturer of the dental unit.

13