mectron COMPACT PIEZO LED Maintenance Manual

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COMPACT PIEZO LED

Û Use and maintenance manual

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TABLE OF CONTENTS

INTRODUCTION .................................................. 3

01.1 Intended use of compact piezo LED .............................. 3

01.2 Description of the device ........................................ 4

01.3 Responsibility waiver ........................................... 4

01.4 Safety precautions .............................................. 4

01.5 Symbols ........................................................6

IDENTIFICATION DATA ........................................... 7

02.1 Identification data of the handpiece ............................. 7

02.2 Identification data of the inserts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

DELIVERY .......................................................... 7

03.1 List of the components of the compact piezo LED ................. 7

04 Û USE ................................................................ 8

04.1 Controls ........................................................ 8

04.2 Switching the device on and off ................................. 8

04.3 Safety precautions before and during use ........................ 8

04.4 Instructions for use ............................................ 10

04.5 Important information on the inserts ........................... 11

DISASSEMBLY OF PARTS FOR CLEANING AND

STERILIZATION

................................................... 12

06 Û CLEANING AND STERILIZATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

06.1 Cleaning and sterilization of the handpiece ...................... 13

06.2 Cleaning and sterilization of the inserts ......................... 16

06.3 Cleaning and sterilization of the torque wrench ................. 18

MAINTENANCE .................................................. 21

DISPOSAL MODES AND PRECAUTIONS ....................... 21

09 Û TECHNICAL DATA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

09.1 Electromagnetic compatibility EN 60601-1-2 ..................... 22

TROUBLESHOOTING ............................................ 26

10.1 Quick solution to problems .....................................26

10.2 Sending the device to an Authorized Mectron Service Service .... 27

WARRANTY ...................................................... 28

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01 Û INTRODUCTION

01.1 Û INTENDED USE OF THE COMPACT PIEZO LED

Read this manual and follow its instructions carefully before proceeding with the use, maintenance, or other operations on the device. Always keep this manual within easy reach. IMPORTANT: to prevent harm to persons

or damages to objects, read all the “Safety precautions”present in the manual with special care. Depending on their degree of seriousness, the safety precautions are classiﬁed with the following indications:

WARNING

(always refers to personal injury)

CAUTION

(refers to possible damage to property)

The purpose of this manual is to make the operator knowledgeable of the safety

precautions and the instructions for a correct use and maintenance of the device and its accessories.

Use of this manual for purposes other than those strictly tied to the use and maintenance of the device is forbidden. The information and illustrations in this manual are updated as of the date of issue reported on the last page. Mectron is committed to continuously update its products with possible modiﬁcations to device components. In case you uncover discrepancies between what is described in this manual and the device in your possession, contact your Retailer or the After-Sales Service of Mectron for clariﬁcations and support.

WARNING: The device must be used

in a dental practice or ambulatory. The device cannot operate in environments where anesthetic or ﬂammable mixtures are present.

WARNING: Qualiﬁed and specialized

personnel. The device must be used

exclusively by specialized and appropriately trained personnel completely familiar with the required techniques and

instructions for use of the equipment. The use of the device does not cause side effects if it is used correctly. An improper use might cause tissues heating.

WARNING: Use the device only for the

intended use. Failure to observe this precaution may cause serious injuries to the patient, the operator, and damages/breakdowns to the device.

By means of the appropriate inserts, the following dental applications can be performed:

- scaling: all the procedures for the removal of bacterial plaque deposits and supragingival, sub-gingival, and interdental calculi, and for the removal of stains;

- periodontology: periodontal treatment for the scaling and root-planing/debridement including cleaning and irrigation of the periodontal pocket;

- cleaning of the implant site surfaces;

- endodontics: all treatments for root canals preparation, irrigation, ﬁlling, condensation of the gutta-percha, endodontic revision and retrograde preparation;

- restoration and prosthesis: cavity preparation and removal of carious tissues, removal of denture and of excess restoration material, condensation of the amalgam, ﬁnishing of the cervical margin.

01 Û INTRODUCTION

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COMPACT PIEZO LED

01.2 Û DESCRIPTION OF THE DEVICE

01.3 Û RESPONSIBILITY WAIVER

The compact piezo LED is a multifunctional ultrasonic piezoelectric scaler. It has been designed in order to offer a product with innovative design and exclusive technical characteristics to the operator, and maximum comfort during the treatment to the patient thanks to a wide range of possible power settings.

The device has an automatic sync circuit which optimizes frequency and power for each available insert, so that the best performance is always assured. The handpiece has a LED light 360° adjustable and can be autoclaved at 135 °C.

The manufacturer Mectron disclaim any liability, expressed or implied, and shall have no responsibility for any direct, indirect or other damages and personal injury arising out in connection with any errors in the use of the device and its accessories.

The manufacturer Mectron shall be under no liability, expressed or implied, with respect to any damages (personal injury and/or damage to property) which might arise or be caused, whether by the customer or by any of the users of the product and its accessories, as result of:

1 Use or procedures different than those

speciﬁed in the intended use of the product;

2 The environmental conditions for the

preservation and storage of the device are not compliant to the precautions indicated in the Chapter 09 - TECHNICAL DATA;

3 The device is not used in compliance

with all the instructions and precautions described in this manual;

4 The electrical system in the premises in

which the device is used is not compliant to the norms in force and to the relative precautions;

5 The assembly operations, extensions,

adjustments, updates, and repairs on the device are performed by personnel not authorized by Mectron;

6 Improper use, mistreatments, and/or

incorrect interventions;

7 Any and all attempts to tamper with or

modify the device, under any circumstance;

8 Use of non-original Mectron inserts that

entail a ﬁnite damage to the threading of the handpeice, thus compromising correct operation and causing risk of harm to the patient;

9 Use of non-original Mectron inserts, used

in accordance to designed and tested settings of Mectron original inserts. The correct use of the settings is guaranteed only with original Mectron inserts;

10 Lack of stock materials (handpiece, inserts,

wrenches) to be used in the event of device stop due to fault or of inconveniences.

01.4 Û SAFETY PRECAUTIONS

WARNING: Contraindications. Do not

use the multipiezo pro on patients who carry heart stimulators (Pace-makers) or other implantable electronic devices. This precaution also applies to the operator.

CAUTION: Contraindications. Ultrasonic

scaler. Do not perform treatments on

prosthetic artifacts made of metal or ceramics. The ultrasonic vibrations could lead to the de-cementing of the artifacts.

WARNING: Contraindications. Do not

perform scaling treatments without water spray in order to avoid the insert overheating which may cause damages to the tooth. Treatments with no water spray can be carried out only with “Dry Work” inserts which do not have the water passage.

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01 Û INTRODUCTION

WARNING: Contraindications.

Interference with other equipment.

Though compliant to the standard IEC 60601-1-2, the multipiezo pro may nonetheless interfere with other devices nearby. The multipiezo pro must not be used near to or stacked on other devices. However, if this were to prove necessary, you must check and monitor correct operation of the device in that conﬁguration.

WARNING: Contraindications.

Interference from other equipment. An electrical scalpel or other electro-surgical units near the multipiezo pro device may interfere with its correct operation.

WARNING: Do not use the device in

places where there is a risk of explosion. The device cannot operate in environments where anesthetic or ﬂammable mixtures are present.

CAUTION: In the case that the end

user, when operating in his or her own medical study or clinic, must subject the electro-medical equipment and systems to periodical inspections in order to adhere to imposed requirements, the test procedures that must be applied to electro-medical equipment and systems to evaluate safety must be performed in line with norm EN 62353 ‘Electro-medical devices - Periodical inspections and tests to be performed after repair interventions on electro-medical devices’.

WARNING: Checking device status

before the treatment. Always check that there is no water underneath the device. Before every treatment, always check that the device works perfectly and that the accessories are efﬁcient. In case you uncover operating abnormalities, do not perform the treatment. Contact an Authorized Mectron Service Center if the abnormalities concern the device.

WARNING: Infections control.

To ensure maximum safety of the patient and the operator, before using all the reusable parts and accessories, make sure

you have ﬁrst cleaned and sterilized them, following the instructions of the Chapter 08 - CLEANING AND STERILIZATION.

WARNING: All the accessories of the

new or repaired devices are not sterile. All new and repaired accessories are supplied in non-sterile conditions. Before use, and after each treatment, they must be cleaned and sterilised in strict compliance with the instructions given in the Chapter 08 CLEANING AND STERILIZATION.

CAUTION: Contraindications. After

having sterilized the handpiece, the inserts, the torque wrench, and any other accessory that can be sterilized in autoclave, wait for them to completely cool down to room temperature prior to reusing them.

WARNING: Breakage and wear-out of

the inserts. High frequency oscillations and wear-out may, in rare circumstances, lead to the breakage of the insert. Deformed or otherwise damaged inserts are susceptible to breakage during their use. These inserts must never be used. If an insert breaks, check that none of its fragments remain in the treated part and, at the same time, apply effective suction to remove them. The patient must be instructed to breathe through his nose during the treatment, or a dental dam must be used to prevent the patient from ingesting fragments of broken inserts. When the nitride coating wears out, the cutting efﬁciency decreases; re-sharpening the insert damages it and is therefore forbidden. Check that the insert is not worn out. During the intervention, frequently check that the insert is intact, especially in its apical part. During the intervention, avoid prolonged contact with retractors or with metallic instrumentation in use. Do not exert excessive pressure on the inserts during their use.

WARNING: Only use original Mectron

inserts, accessories, and spare parts.

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COMPACT PIEZO LED

Serial number

Lot number

Product code

CAUTION: read the instructions for use

Operating instructions

Temperature limitation - transport and storage conditions

Humidity limitation - transport and storage conditions

Atmospheric pressure limitation - transport and storage conditions

It indicates compliance with the CE 93/42 CEE EN 60601-1 and EN 60601-1-2. Notiﬁed body: CERMET.

MET Mark UL CSA conformity

Manufacturer

QTY.1 Quantity of parts in the pack = 1

Applied part of type “B” as per norm EN 60601-1

Can be sterilized in autoclave up to a maximum temperature of 135° C

Non-sterile

The device and its accessories must not be disposed of or treated as solid urban wastes

Alternating current

Direct current

Dangerous voltage

01.5 Û SYMBOLS

UL 60601-1 CSA C22.2

No. 601-1 - E113015

-10 °C

70 °C

10 %

90 %

1060 hPa

500 hPa

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02 Û IDENTIFICATION DATA

Each handpiece is laser-marked with the Mectron logo (ref. 1), and the handpiece serial number (ref. 2).

The following data are laser-marked on each insert: the name of the insert (ref. 3), the Mectron logo (ref. 4) and the lot number to which the insert belongs (ref. 5).

02.1 Û IDENTIFICATION DATA OF THE HANDPIECE

02.2 Û IDENTIFICATION DATA OF THE INSERTS

An exact description of the model and of the serial number of the device will enable our AfterSales Service to provide fast and efﬁcient support. Always refer these data whenever you contact an Authorized Mectron Service Center.

03 Û DELIVERY

03.1 Û LIST OF THE COMPONENTS OF THE COMPACT PIEZO LED

The compact piezo LED consists of:

A scaler handpiece complete with LED light front cone B Mectron torque wrench C inserts/insert kits D metal front cone without light E manual of use and maintenance

3 4 5

B C D

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COMPACT PIEZO LED

The compact piezo LED consists of accessories that can be ordered separately. Refer to the “Packing List” included in your package, so that you may exactly know the quantity and type of the accessories supplied with the device you have purchased. The package of the device is sensitive to strong collisions, because it contains electronic components. Therefore, special precautions must be taken for transport and storage. All the materials shipped by Mectron have been inspected upon their delivery. The device is delivered duly protected and packed.

When receiving the device, check for the possible presence of damages incurred during the transport and, should that be the case, ﬁle a complaint with the transporter. Preserve the package in the event that you need to send the device to an Authorized Mectron Service Center and so that you can place it back inside during prolonged periods of disuse.

WARNING: Before starting to operate

with the device, make sure that you have stock material (handpiece, inserts, wrenches) available to use in case the device stops due to a fault or of inconveniences.

04 Û USE

04.1 Û CONTROLS

The compact piezo LED offers a wide range of power settings: from a sub-gengival perio treatment in soft mode to a more aggressive scaling. Read the manual of use of the

dental chair on which the compact piezo LED is intalled in order to have the complete description of the power settings at your disposal.

04.2 SWITCHING THE DEVICE ON AND OFF

Read the manual of use of the dental chair on which the compact piezo LED is intalled in order to know how to switch the device on

and off, and how to control the LED light on the front end of the handpiece.

04.3 Û SAFETY PRECAUTIONS BEFORE AND DURING USE

WARNING: Before starting to

operate with the device, make sure that you have stock material (handpiece, inserts, wrenches) available to use in case the device stops due to a fault or of inconveniences.

WARNING: Only use original Mectron

inserts, accessories, and spare parts.

WARNING: Use of non-original

Mectron inserts: this use entails ﬁnite

damage to the handpiece threading, thus compromising correct operation and risking to cause harm to the patient.

WARNING: Contraindications. Do not

use the compact piezo LED on patients who carry heart stimulators (Pace-makers) or other implantable electronic devices. This precaution also applies to the operator.

CAUTION: Contraindications. Ultrasonic

scaler. Do not perform treatments on

metal or ceramic/porcelain prosthetic artifacts. The ultrasonic vibration could cause decementation/loosening of such artifacts.

CAUTION: Only use inserts with water

passage when performing treatments that require irrigation.

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04 Û USE

WARNING: Contraindications. Do not

perform scaling treatments without water spray in order to avoid the insert over-heating which may cause damages to the tooth. Treatments with no water spray can be carried out only with “Dry Work” inserts which do not have the water passage.

WARNING: Treatments that require

irrigation. Always check operation of the irrigation before and during use. Make sure the ﬂuid outﬂows from the insert. Do not use the device if the irrigation does not work or if the pump is defective.

WARNING: Checking device status

before the treatment. Always check that there is no water underneath the device. Before every treatment, always check that the device works perfectly and that the accessories are efﬁcient. DO NOT use the device and its accessories if damage is apparent. Contact an Authorized Mectron Service Center if the abnormalities concern the device.

CAUTION: Do not activate the

handpiece while the insert is in contact with the part to be treated. Doing so, will not allow the electronic control circuit of the device to recognize the best point of resonance of the insert, required for efﬁcient and optimum performance.

WARNING: Before every treatment,

make sure that the insert appropriate for the treatment is inserted on the handpiece. Exclusively use the original Mectron torque wrench to fasten the insert to the handpiece.

WARNING: Do not change the insert

with handpiece running, to prevent causing wounds to the operator.

WARNING: Control of infections.

First Use The reusable accessories (brand new or returned by service) are delivered in NON-STERILE conditions and must be prepared prior to use by applying the procedures given in Chapter 06 CLEANING AND STERILIZATION. Every use Once used, each reusable accessory must be thoroughly reprocessed prior to reuse, according to the procedures given in Chapter 06 - CLEANING AND STERILIZATION.

CAUTION: Contraindications. Allow

reusable, autoclavable items (the handpiece, the inserts, the torque wrench, and any other accessory that can be sterilized ) to gradually return to room temperature after steam sterilization and prior to usage. The cooling process must not be accelerated.

CAUTION: The electrical contacts inside the cord and handpiece connectors must be dry. Before connecting the handpiece

to the cord, make sure that the electrical contacts of both connectors are perfectly dry, especially after the sterilization cycle in autoclave. If need be, dry the contacts by blowing compressed air onto them.

WARNING: Breakage and wear-out of the inserts. High frequency oscillations and wear-out may, in rare circumstances, lead to the breakage of the insert. Do not bend, change shape of, or resharpen an insert in any way. Bending an insert or applying leverage on it can lead to its breakage. Deformed or otherwise damaged inserts are susceptible to breakage during their use. These inserts must never be used. Excessive pressure applied to insert during its use can cause insert fracture. Should an insert fracture during use, check that none of its fragments remain in the treated part and, at the same time, apply effective suction to remove them. The patient must be instructed to breathe through his nose during the treatment, or a dental dam must be used to prevent the patient from ingesting fragments of broken inserts. When the nitride coating wears out, the cutting efﬁciency decreases; re-sharpening the insert damages it and is therefore forbidden. Prior to each use check that the insert is not worn out. During the intervention, frequently check that the insert is intact, especially its top. During the intervention, avoid prolonged contact with retractors or with metallic instrumentation in use.

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COMPACT PIEZO LED

click!

04.4 INSTRUCTIONS FOR USE

Correctly connect the handpiece on its cord making sure to match the dot on the handpiece connector with the groove on the cord connector. Make sure that the electrical contacts of both connectors are perfectly dry, if need be, dry them by blowing compressed air;

Screw the chosen insert onto the compact piezo LED handpiece, until it reaches the limit stop;

Tighten the insert by using the Mectron torque wrench.

To correctly use the Mectron torque wrench, operate as follows:

put the insert inside the wrench as shown; ﬁrmly hold the central body of the

handpiece;

CAUTION:The handpiece must not be

grabbed by its terminal part and/or cord, but only by its central body. The handpiece must not be rotated, but must be grasped ﬁrmly, and you must only rotate the wrench.

rotate the wrench clockwise until the friction snaps (the external body of the wrench rotates compared to the handpiece, emitting mechanical “CLICK” sounds). The insert is now perfectly tightened.

CORRECT

NOT CORRECT

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04 Û USE

The position of the LED light on the front terminal of the handpiece can be adjusted in the following way:

• Hold the body of the handpiece and lightly unscrew the metal ring nut located at the base of the front terminal, rotating it counter-clockwise.

• Rotate the front terminal so that the LED light goes into the desired and necessary position.

To fasten it into position, screw the metal ring nut, rotating it clockwise.

Select the desired power and irrigation levels according to the instructions given by the chair manufacturer.

NOTE: activate the WATER function if you need to perform a treatment that forsees the use of water spray, otherwise switch the WATER function to OFF.

Activate the compact piezo LED. At the end of the treatment always put the

scaler handpiece back into its seat.

WARNING:

- When the titanium nitride coating is visibly worn out, the insert must be replaced. Use of an overly worn out insert reduces its efﬁciency.

- Diamond-coated inserts: the diamond inserts must be replaced when the titanium nitride coating is visibly worn out and, at any rate, after a maximum of 10 treatments.

- Do not activate the handpiece while the insert is in contact with the part to be treated. Doing so, will not allow the electronic control circuit of the device to recognize the best point of resonance of the insert, required for efﬁcient and optimum performance.

- Check the condition of wear of the insert and that it is intact before and during every use. If a damage or drop in performance is noted replace it with a new one.

- Use original Mectron inserts only. Use of non-original inserts, in addition to

voiding the warranty, damages the

threading of the compact piezo LED handpiece, with the risk of no longer being able to screw the original inserts correctly during subsequent use. Moreover, the device settings are tested and guaranteed to operate correctly only when original Mectron inserts are used.

- Do not change the shape of the insert in any way by either bending or ﬁling it. This could cause it to break.

- Do not use an insert that has suffered any type of deformation.

- Do not attempt to sharpen the insert used.

- Always check that the threaded parts of the insert and of the handpiece are perfectly clean – see Chapter 06 CLEANING AND STERILIZATION.

- If excessive pressure is applied on the

insert, it can cause the insert to break and possibly harm the patient.

04.5 Û IMPORTANT INFORMATION ON THE INSERTS

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COMPACT PIEZO LED

WARNING: Make sure that the device

is not active. Always make sure that the

footswitch is not pressed during the disassembling of parts before cleaning and sterilization interventions

Before moving on to the cleaning procedures described in Chapter 06 - CLEANING AND STERILIZATION, disconnect all the accessories and components of the compact piezo LED.

DISASSEMBLY OF PARTS FOR CLEANING

AND STERILIZATION

Unscrew the front terminal from the handpiece;

NOTE: on the LED front cone the metal ring cannot be separated from the plastic cone.

CAUTION: Do not attempt to

unscrew or turn the connector when disconnecting the handpiece. The connector could get damaged.

Disconnect the handpiece from its cord;

If present, unscrew the insert from the handpiece by using the torque wrench;

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06 Û CLEANING AND STERILIZATION

PREPARATION

- Disconnect the handpiece from the cord of the dental chair (see Chapter 05);

- If present, disconnect the insert from the handpiece with the torque wrench (see Chapter 05);

- Unscrew the front terminal (see Chapter 05).

CAUTION: Do not attempt to unscrew

or turn the connector when disconnecting the handpiece. The connector could get damaged.

CAUTION: Do not immerge the

handpiece in disinfectant solutions or other liquids, because it could get damaged.

CAUTION: Do not immerge the

handpiece in an ultrasonic tank.

CLEANING AND DISINFECTION METHOD - Handpiece

Prepare an enzymatic detergent solution with pH 6-9, as per the instructions of the manufacturer;

06.1 Û CLEANING AND STERILIZATION OF THE HANDPIECE

MATERIALS NECESSARY

- Enzymatic detergent with pH 6-9

- Water

- Container for solution with enzymatic liquid

- If need be, non-aggressive disinfectant solution with neutral pH (pH7)

- Clean and soft cloth with low ﬁber-release

- Brush with soft nylon bristles

- Distilled water

- Compressed air

- Single-use sterilization packets

- Steam sterilization

CAUTION: If you intend to disinfect,

we recommend that you use water-based disinfectant solutions with a neutral pH (pH7). Alcohol-based disinfectant solutions and hydrogen peroxide are contraindicated, because they can fade the color and/or damage the plastic materials. This also holds true for chemical products such as acetone and alcohol. Always rinse with sterile water to preserve the disinfection.

CAUTION: Once used, correctly dispose

of the enzymatic detergent solution, do not recycle.

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COMPACT PIEZO LED

Delicately clean the surface of the handpiece using the enzymatic detergent solution with the aid of a brush with soft nylon bristles, placing special care to the following areas:

- threading of the handpiece

- titanium stem

- front terminal in its external and internal parts

Accurately rinse with tap water to eliminate any detergent residues and perform the last rinse with distilled water;

Thoroughly dry all the parts, especially the electrical contacts, blowing on them with compressed air;

Clean the surface of the handpiece and of its connector with a clean, soft cloth with low ﬁber-release, dampened with a detergent solution (pH 6-9) and, if need be, disinfect with a non-aggressive disinfectant solution with neutral pH (pH7), following the instructions provided by the manufacturer of the solution;

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06 Û CLEANING AND STERILIZATION

Once you’ve ﬁnished the cleaning operations, check all the objects under an adequate source of light, paying attention to the details that could conceal dirt residues (threading, cavities, grooves) and, if need be, repeat the cleaning cycle. Finally, check the integrity of those parts and elements that may have worn out during their use;

Individually seal the handpiece (without inserts) and the front terminal in single-use packets for separate sterilization cycles. Proceed with the sterilization.

STERILIZATION METHOD - Handpiece

CAUTION:The electrical contacts of the

cord connector must be dry. At the end of the sterilization cycle and before connecting the handpiece to the cord, make sure that the electrical contacts and the connector are perfectly dry; if need be, dry them by blowing compressed air.

The handpiece is built with materials that resist to a maximum temperature of 135°C for a maximum time of 20 minutes. The sterilization process in steam autoclave must be performed setting the parameters indicated below, which are validated by Mectron and reach the sterilization safety levels (SAL 10

-6

- 3 times Pre-vacuum (minimum pressure 60 mBar).

- Sterilization temperature 132°C (interval 0°C ÷ +3°C).

- Sterilization time 4 minutes.

- Minimum drying time 20 minutes.

All the sterilization phases must be performed by the operator in compliance to the norms UNI EN ISO 17665-1:2007, UNI EN ISO 556-1:2002 e ANSI/AAMI ST46:2002.

CAUTION: Do not sterilize the

handpiece with the insert screwed onto it.

WARNING: Checking infections - Parts

that can be sterilized - Diligently remove all residues of organic dirt before the sterilization.

CAUTION: Perform the sterilization

using a water steam autoclave only. Do not use any other sterilization procedure (dry heat, irradiation, ethylene oxide, gas, low temperature plasma, etc.).

CAUTION: Do not exceed the allowed

load of the steam sterilizer.

CAUTION: At the end of the steriliza-

tion cycle, let the handpiece cool down completely prior to using it.

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COMPACT PIEZO LED

06.2 Û CLEANING AND STERILIZATION OF THE INSERTS

PREPARATION

- Disconnect the insert from the handpiece with the torque wrench (see Chapter 05).

CAUTION: Always disconnect the insert

from the handpiece before proceeding to its cleaning and sterilization.

MATERIALS NECESSARY

- Enzymatic detergent with pH 6-9

- Water

- Ultrasound tank

- Brush with soft nylon bristles

- Compressed air

- Distilled water

- Single-use sterilization packets

- Steam sterilization

- Syringe

CAUTION: Do not use hydrogen

peroxide. If you intend to disinfect the

inserts, do not use hydrogen peroxide, but only disinfectants with neutral pH (pH7); always rinse with sterile water to preserve the disinfection.

CAUTION: Once used, correctly dispose

of the enzymatic detergent solution, do not recycle.

CLEANING AND DISINFECTION METHOD - Inserts

Prepare an enzymatic detergent solution with pH 6-9, as per the instructions of the manufacturer;

Place the insert in the ultrasound tank submerged by the enzymatic detergent solution at 40°C, for at least 10 minutes;

10 min 40°C

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06 Û CLEANING AND STERILIZATION

Delicately brush the surface of the insert with the brush with soft nylon bristles;

Remove the insert from the ultrasonic tank and rinse with distilled water;

Rinse the internal canal of the insert with distilled water injected under pressure (3,8 bar) for at least 10 seconds to eliminate all residues;

Once you’ve ﬁnished the cleaning operations, check all the inserts under an adequate source of light, paying attention to the details that could conceal dirt residues (threading, cavities, grooves) and, if need be, repeat the cleaning cycle;

CAUTION: Before starting the

sterilization cycle, make sure that the insert is thoroughly dry, both externally and internally. For this purpose, blow compressed air both externally and through the internal thru hole; this will prevent the onset of stains and haloes on the surface or rust inside the insert.

10 sec

3,8 bar

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COMPACT PIEZO LED

Individually seal the inserts in single-use sterilization packets. Sterilize the inserts in a steam autoclave.

STERILIZATION METHOD - Inserts

The sterilization process in steam autoclave must be performed setting the parameters indicated below, which are validated by Mectron and reach the sterilization safety levels (SAL 10

-6

- 3 times Pre-vacuum (minimum pressure 60 mBar).

- Sterilization temperature 132°C (interval 0°C ÷ +3°C).

- Sterilization time 4 minutes.

- Minimum drying time 20 minutes.

All the sterilization phases must be performed by the operator in compliance to the norms UNI EN ISO 17665-1:2007, UNI EN ISO 556-1:2002 e ANSI/AAMI ST46:2002.

CAUTION: Do not sterilize the insert

screwed onto the handpiece.

WARNING: Checking infections - Parts

that can be sterilized - Diligently remove all residues of organic dirt before the sterilization.

CAUTION: Perform the sterilization

using a water steam autoclave only. Do not use any other sterilization procedure (dry heat, irradiation, ethylene oxide, gas, low temperature plasma, etc.).

CAUTION: Do not exceed the allowed

load of the steam sterilizer.

06.3 Û CLEANING AND STERILIZATION OF THE TORQUE WRENCH

PREPARATION

- Take the wrench.

MATERIALS NECESSARY

- Enzymatic detergent with pH 6-9

- Water

- Ultrasound tank

- Brush with soft nylon bristles

- Distilled water

- Clean and soft cloth with low ﬁber-release

- Medical degree lubricant

- Single-use sterilization packets

- Steam sterilization

CAUTION: Do not use hydrogen

peroxide. If you intend to disinfect the

wrench, do not use hydrogen peroxide, but only disinfectants with neutral pH (pH7); always rinse with sterile water to preserve the disinfection.

CAUTION: Once used, correctly dispose

of the enzymatic detergent solution, do not recycle.

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06 Û CLEANING AND STERILIZATION

CLEANING AND DISINFECTION METHOD - Torque wrench

Prepare an enzymatic detergent solution with pH 6-9, as per the instructions of the manufacturer;

Place the insert in the ultrasound tank submerged by the enzymatic detergent solution at 40°C, for at least 10 minutes;

Rinse with tap water to eliminate all residues;

Delicately brush the surface of the wrench with a brush with soft nylon bristles using distilled water;

Dry the wrench with a clean, soft cloth with low ﬁber-release;

10 min 40°C

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COMPACT PIEZO LED

Lubricate with medical degree lubricant in the indicated point;

Once you’ve ﬁnished the cleaning operations, check the wrench under an adequate source of light, paying attention to the details that could conceal dirt residues (cavities, grooves) and, if need be, repeat the cleaning cycle.;

Seal the wrench individually in a single-use sterilization packet. Sterilize the wrench in a steam autoclave.

CAUTION: do not use lubricants

based on oil or silicon.

STERILIZATION METHOD - Torque wrench

The sterilization process in steam autoclave must be performed setting the parameters indicated below, which are validated by Mectron and reach the sterilization safety levels (SAL 10-6):

- 3 times Pre-vacuum (minimum pressure 60 mBar).

- Sterilization temperature 132°C (interval 0°C ÷ +3°C).

- Sterilization time 4 minutes.

- Minimum drying time 10 minutes.

All the sterilization phases must be performed by the operator in compliance to the norms UNI EN ISO 17665-1:2007, UNI EN ISO 556-1:2002 e ANSI/AAMI ST46:2002.

WARNING: Checking infections - Parts

that can be sterilized - Diligently remove all residues of organic dirt before the sterilization.

CAUTION: Perform the sterilization

using a water steam autoclave only. Do not use any other sterilization procedure (dry heat, irradiation, ethylene oxide, gas, low temperature plasma, etc.).

CAUTION: do not exceed the allowed

load of the steam sterilizer.

Page 21

07 Û MAINTENANCE

Û MAINTENANCE

If the device is not used for prolonged time, observe the following recommendations:

1 Before carrying on any kind of maintenace

activity make sure that the device is not active;

2 Prior to using the device again, clean and

sterilize the handpiece, the inserts and the wrench following the instructions provided in Chapter 06 - CLEANING AND STERILIZATION;

3 Check that the inserts are not worn out,

deformed, or broken, placing special attention to the integrity of their tip

WARNING: Periodically check that

the scaler cord is intact; if it is damaged, contact the dental chair manufacturer in order to replace it with an original Mectron spare part.

08 Û

DISPOSAL MODES AND PRECAUTIONS

WARNING: Hospital wastes.

Hospital wastes. Treat the following items as hospital waste:

- Inserts: when they are worn out or

broken;

- Torque wrench for inserts: when worn

out or broken.

The use and throw-away materials and materials that entail a biological risk must

be disposed of in accordance to the norms in force locally concerning hospital wastes. compact piezo LED must be disposed of and treated as a waste for separate collection. Disregard of the previous points may entail a ﬁne, pursuant to Directive 2002/96/CE. It is up to the purchaser to hand over the device for its disposal to the retailer who supplies him new equipment; the instructions for proper disposal are available from Mectron.

09 Û TECHNICAL DATA

Device compliant to Dir. 93/42/CEE: Class IIa Classiﬁcation as per EN 60601-1: The class deﬁnition is delegated to the dental chair

manufacturer using the compact piezo LED in its unit

Applied part type “B” (handpiece, insert)

IP According to the dental chair manufacturer

Device for intermittent operation: 60sec. ON - 30sec. OFF with irrigation 30sec. ON - 120sec. OFF without irrigation

Power supply voltage: Power supply compliant to IEC/EN 60601-1:

24V 50/60 Hz, or 32V

Max. power absorbed: 40 VA Operating frequency: Automatic scan

From 24 KHz a 36 KHz Power types: Adjustable according to the instructions given by the

dental chair manufacturer

Water supply: Adjustable according to the instructions given by the

dental chair manufacturer

Operating pressure from 1 to 6 bar LED system of the handpiece: Adjustable according to the instructions given by the

dental chair manufacturer

Page 22

COMPACT PIEZO LED

Protections of the APC circuit: No handpiece detected Cord interruption Insert not tightened correctly or broken

Operating conditions: from +10°C to +40°C Relative humidity from 30% to 75%

Pressure of air P: 800hPa/1060hPa

Transport and storage conditions: from -10°C to +70°C Relative humidity from 10% to 90% Pressure of air P: 500hPa/1060hPa

09.1 Û ELECTROMAGNETIC COMPATIBILITY EN 60601-1-2

WARNING: Interference with other

equipment. Though compliant with the

standard IEC 60601-1-2, the compact piezo LED may nonetheless interfere with other devices nearby. The compact piezo LED must not be used near to or stacked on other devices. If adjacent or stacked use is necessary, the compact piezo LED and the other devices must be observed and checked to verify normal operation in the conﬁguration in which they will be used.

WARNING: Portable and mobile radio

communication appliances may affect the correct functioning of the device.

WARNING: Interference from other

equipment. The use of an electrical scalpel or other electro-surgical unit/s near the compact piezo LED may interfere with its correct functioning.

WARNING: The device requires speciﬁc

EMC precautions and must be installed and activated in accordance with the EMC information given in this paragraph.

Guidance and manufacturer’s declaration - Electromagnetic emissions

The compact piezo LED is intended for use in the electromagnetic environment speciﬁed below. The customer or user of the compact piezo LED should ensure that it is used in such an environment.

Emissions test

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage ﬂuctuations / ﬂicker emissions IEC 61000-3-3

Compliance

Group 1

Class B

Class A

Complies

Electromagnetic environment – Guidance

The compact piezo LED only uses RF energy for internal function. Therefore, its FR emissions are very low and are not likely to cause any interference with nearby electronic equipment.

The compact piezo LED is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Page 23

09 Û TECHNICAL DATA

Guidance and manufacturer’s declaration - Electromagnetic immunity

The compact piezo LED is intended for use in the electromagnetic environment speciﬁed below. The customer or user of the compact piezo LED should ensure that it is used in such an environment.

Immunity

test

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Power frequency (50/60 Hz) magnetic ﬁeld IEC 61000-4-8

N.B.: UT is the AC mains voltage prior to application of the test level.

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Test level

IEC 60601

±6 kV contact ±8 kV air

±2 kV for power supply lines

±1 kV for input/output lines

3 A/m

±1 kV differential mode

±2 kV common mode

<5 % U

T (>95 % dip

in UT) for 0,5 cycles

40 % UT (60 % dip

in U

T) for 5 cycles

70 % UT (30 % dip

in UT) for 25 cycles

<5 % U

(>95 % dip in UT) for 5 s

Electromagnetic

environment - Guidance

Floors should be wood, concrete or ceramic tile. If ﬂoors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

Power frequency magnetic ﬁelds should be at levels characteristic of a typical location in a commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Compliance

level

The device continues to work regularly and in safety

The device can vary from the required levels of immunity with a duration of <5% / >95% / 5 s as long as the device remains in safety, no malfunctions have been dected and can be restored to pre-test status with the intervention of the operator

Page 24

COMPACT PIEZO LED

Guidance and manufacturer’s declaration - Electromagnetic immunity

The compact piezo LED is intended for use in the electromagnetic environment speciﬁed below. The customer or user of the compact piezo LED should ensure that it is used in such an environment.

Immunity

test

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

N.B.: (1) at 80 MHz and 800 MHz, the higher frequency range applies. (2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reﬂection from structures, objects and people.

a Field strengths from ﬁxed transmitters, such as base stations for radio (cellular/cordless) telephones and land

mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with any reasonable accuracy. To assess the electromagnetic environment due to ﬁxed RF transmitters, an electromagnetic site survey should be considered. If the measured ﬁeld strength in the location in which the compact piezo LED is used exceeds the applicable RF compliance level given above, the compact piezo LED should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the compact piezo LED.

b Over the frequency range from 150 kHz to 80 MHz, ﬁeld strengths should be less than 3 V/m.

Test level

IEC 60601

3 Veff from 150 kHz to 80 MHz

3 V/m from 80 MHz to 2,5 GHz

Electromagnetic environment

Guidance

Portable and mobile RF communications equipment should be used no closer to any part of the device including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance d = 1,2 √P

d = 1,2 √P from 80 MHz to 800 MHz d = 2,3 √P from 800 MHz to 2,5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from ﬁxed RF transmitters, as determined by an electromagnetic site survey

, may be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

Compliance

level

The device continues to work regularly and in safety

Page 25

09 Û TECHNICAL DATA

Recommended separation distances between portable and mobile RF

communications equipment and the compact piezo LED

The compact piezo LED is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the compact piezo LED can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile FR communications equipment (transmitters) and the compact piezo LED as recommended below, according to the maximum output power of the communications equipment.

Rated maximum

output power of transmitter

‘W’

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be calculated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

N.B.: (1) at 80 MHz and 800 MHz, the higher frequency range applies. (2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reﬂection from structures, objects and people.

from 150 kHz to 80 MHz

d = 1,2 √P

from 800 MHz to 2,5 GHz

d = 2,3 √P

Separation distance according to the frequency of transmitter ‘m’

from 80 MHz to 800 MHz

d = 1,2 √P

Page 26

COMPACT PIEZO LED

10 Û TROUBLESHOOTING

10.1 Û QUICK SOLUTION TO PROBLEMS

Problem Possible cause Solution

Turn on the water function on the dental chair

The device is on

but not working

(intervention of the APC

protection circuit)

The Water function is off

No liquid outﬂows

from the insert during

operation

Handpiece not connected to the cord

Connect the handpiece to the cord

Interruption of a cord wire

Handpiece defective

Contact an Authorized Mectron Service Center

Sync circuit malfunction

Contact an Authorized Mectron Service Center

A slight whistling sound

coming from the compact

piezo LED handpiece is

heard during operation.

The insert type does not foresee liquid passage

Use an insert type with liquid passage

The insert is obstructed

The handpiece is obstructed

Unscrew the insert from the handpiece and free the insert water passage by blowing compressed through it. If the problem persists, replace the insert with a new one

Contact an Authorized Mectron Service Center

The insert is not correctly tightened on the handpiece

Unscrew and correctly screw the insert again with the Mectron torque wrench (see paragraph 04.4)

Insert broken, worn-out, or deformed

Replace the insert with a new one

Handpiece or cord connector contacts wet

Thoroughly dry the contacts with compressed air

The irrigation circuit has not been completely ﬁlled

Fill the irrigation circuit

The insert is not correctly tightened on the handpiece

Unscrew and correctly screw the insert again with the Mectron torque wrench (see paragraph 04.4)

Page 27

10 Û TROUBLESHOOTING

Problem Possible cause Solution

The insert is not correctly maintained

Clean and maintain the insert correctly (see paragraph 06.2)

10.2 Û SENDING THE DEVICE TO AN AUTHORISED MECTRON SERVICE CENTRE

In the event that technical assistance is needed on the device, contact one of the Authorized Mectron Service Centers or your Retailer. Do not attempt to repair or modify the device and its accessories.

Clean and sterilize all the parts that need to be sent to an Authorized Mectron Service Center, following the instructions provided in Chapter 06 - CLEANING AND STERILIZATION. Leave the sterilized parts in the packet, procedure that conﬁrms the sterilization process has been performed.

The cleaning and sterilization requirements are in line with those in force concerning the safeguarding of health and safety on the workplace, as per Law Decree 626/94 and DLgs 81/08 and its subsequent amendments, both laws of the Italian State. In the case that the customer does not fulﬁll the requirements, Mectron reserves the right to charge him or her the cleaning and sterilization expenses, or to reject the goods received in unsuitable conditions, returning them to the customer, at his or her expense, for them to be correctly cleaned and sterilized.

The device must be returned properly packaged, accompanied by all the accessories and by a sheet bearing the:

• Data of the owner with telephone number

• Product name

• Serial number and/or lot number

• Reason for goods returned / description of the malfunction

• Photocopy of delivery note or purchase invoice of the device

CAUTION: Package

Pack the device in its original package to prevent damages during transport.

Once the material has been received by the Authorized Mectron Service Center, qualiﬁed technical personnel will provide its evaluation to the given circumstance. The repair works will be performed only upon their prior acceptance by the end customer. For further details, contact the closest Authorized Mectron Service Center or your retailer.

Unauthorized repair works may damage the system and make the warranty void, and absolve Mectron of any responsibility for direct or indirect harm to persons or damages to things.

The insert is not correctly tightened on the handpiece

Insert broken, worn-out, or deformed

Unscrew and correctly screw the insert again with the Mectron torque wrench (see paragraph

04.4)

Replace the insert with a new one

Insufﬁcient

performance

Page 28

COMPACT PIEZO LED

11 Û WARRANTY

All the Mectron devices are subjected to an accurate end inspection that ascertains their full functionality before they are placed on the market. Mectron provides warranty on the compact piezo LED purchased new from a retailer or a Mectron importer to cover material or manufacturing defects for:

- 2 YEARS (TWO) on the device from the date of purchase;

- 1 YEAR (ONE) on the handpiece complete with cord from the date of purchase.

The accessories are not included in the warranty.

During the period in which the warranty is valid, Mectron commits itself to repair (or at its own free choice, replace) those product parts that were to prove defective according to its judgment, free of charge. Entire replacement of the Mectron products is excluded.

The warranty of the manufacturer and the homologation of the device are not valid in the following cases:

- The device is not used in accordance to the intended use foreseen for it;

- The device is not used in compliance to all the instructions and precautions described in this manual;

- The electrical system in the premises in which the device is used is not compliant to the norms in force and to the relative precautions;

- The assembly operations, extensions, adjustments, updates, and repair works are performed by personnel not authorized by Mectron;

- The environmental conditions for the preservation and storage of the device are not compliant to the precautions indicated in the Chapter 09 - TECHNICAL DATA;

- Use of non-original Mectron inserts, accessories, and spare parts that can compromise correct device operation and cause harm to the patient;

- Accidental breakage due to transport;

- Damages due to incorrect use or negligence, or to connection to a power voltage other than the one foreseen;

- Warranty expiry.

PLEASE NOTE The warranty is valid only if the warranty sheet annexed to the product has been ﬁlled out in all its parts, and sent to our ofﬁces or possibly to the retailer or Mectron importer within 20 (twenty) days from the date of purchase, which is the date that appears on the delivery note/purchase invoice issued by the retailer/importer. To beneﬁt of the warranty service, the customer must return, at his own expense, the device to be repaired to the retailer/Mectron importer from whom he has purchased the product.

See paragraph 10.2 for the details relative to the procedure to send the device to an Authorized Mectron Service Center.

The indications that appear in this publication are not binding and can be modiﬁed without fore-notice. The Italian version of this manual is the original document from which its translations have been obtained. In case of any discrepancy, the Italian version will have pertinence.

Texts, images, and graphics of this manual are property of Mectron S.p.A., Carasco, Italy. All rights reserved. The contents cannot be copied, distributed, changed, or made available to third parties without the written approval of Mectron S.p.A.

Page 29

Manuale d’uso e manutenzione Compact Piezo Led

02150238 - Rev. 01 22-09-2012

Reseller - Rivenditore - Wiederverkäufer - Revendeur - Revendedor

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: [email protected]