mectron piezo smart Maintenance Manual

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English

0476

piezo smart

Manual of use and maintenance

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piezo smart - manual of use and maintenance

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Summary

00.0 Introduction

00.0 Introduction ........................................................................................................................ .....3

00.1 Foreword .................................................................................................................... .....3

00.2 Description of the device ............................................................................................ .....3

00.3 Intended use ............................................................................................................... .....4

00.4 Safety Requirements .................................................................................................. .....4

01.0 Identification data .............................................................................................................. .....6

01.1 Identification ............................................................................................................... .....6

01.2 Equipment identification plate ..................................................................................... .....6

01.3 Identification place of the scaler handpiece ................................................................ .....6

02.0 Testing ................................................................................................................................ .....7

02.1 Testing of the equipment ............................................................................................ .....7

03.0 Delivery............................................................................................................................... .....7

03.1 Delivery of the device ................................................................................................. .....7

03.2 List of material included in the standard supply .......................................................... .....8

04.0 Installation.......................................................................................................................... .....8

04.1 Safety requirements during installation ...................................................................... .....8

04.2 Installation of the peristaltic pump .............................................................................. ...11

04.3 Connection of the device ............................................................................................ ...11

04.4 Preparing the bottle .................................................................................................... ...13

04.5 Installing the bottle on the equipment ......................................................................... ...13

04.6 Removing the bottle from the device .......................................................................... ...13

05.0 Use ...................................................................................................................................... ...14

05.1 Controls ...................................................................................................................... ...14

05.2 Switching on and off ................................................................................................... ...15

05.3 Description of the display and functions ..................................................................... ...15

05.4 Safety Requirements during use ................................................................................ ...16

05.5 Safety and alarm circuits ............................................................................................ ...17

05.6 Instructions for use ..................................................................................................... ...18

05.7 Checking the inserts for wear ..................................................................................... ...18

06.0 Cleaning, disinfection and sterilisation........................................................................... ...19

06.1 CLEAN Function - Cleaning of the liquid circuit .......................................................... ...19

06.2 Cleaning and disinfecting the housing of the device .................................................. ...19

06.3 Sterilisation procedure ............................................................................................... ...20

06.4 Autoclave sterilisation of the handpiece ..................................................................... ...20

06.5 Autoclave sterilisation of the inserts ........................................................................... ...21

06.6 Autoclave sterilisation of the torque wrench for tightening the inserts ........................ ...21

07.0 Scheduled maintenance ................................................................................................... ...21

07.1 Cleaning of the water circuit ....................................................................................... ...21

07.2 External power supply unit ......................................................................................... ...21

07.3 Replacement of the peristaltic pump .......................................................................... ...21

08.0 Procedures for disposal and precautions ...................................................................... ...22

09.0 Inserts for Mectron scaler and how to use them ............................................................ ...22

10.0 Trouble-shooting ............................................................................................................... ...23

11.0 Symbols.............................................................................................................................. ...25

12.0 Technical specifications ................................................................................................... ...26

12.1 Electromagnetic compatibility EN 60601-1-2 ............................................................... ...27

13.0 Warranty ............................................................................................................................. ...31

00.1 Foreword

Read this manual carefully before installing the equipment, using it or carrying out maintenance or any other activities on it.

Always keep this manual within easy reach.

Important: To avoid causing injuries or damage to property, read all the points concerning “Safety Requirements” contained in this manual particularly carefully. Depending on the level of risk involved, safety requirements are classed under the following headings:

DANGER (always referred to personal injury) WARNING (referred to possible damage to property)

The purpose of this manual is to bring the safety requirements, the installation procedures and the instructions for correct use and maintenance of the device to the knowledge of operators. The user is not authorised to camper with the equipment under any circumstances. If any problems are encountered, please contact a Mectron Service Centre. Anny attempts on the part of the user or of any unauthorised personnel to tamper with or alter the device will invalidate the warranty and release the manufacturer from any liability in respect of any harm or damage to persons or property. The information and illustrations container in this manual are up-dated to the date of publication indicated on the last page. MECTRON are committed to continuous up-dating of their products, which may entail changes to components of the device. If any discrepancies are found between the descriptions container in the manual and your device, please contact your dealer of the MECTRON Afer-Sale Service. Using this manual for purposes other to those relating to the installation, use and maintenance of the equipment is strictly prohibited.

00.2 Description of the device

The piezo smart is an extremely modern ultrasound piezoelectric scaler enabling application the US technique to dentistry and is manufactured using state-of-the-art technology. The device has an automatic tuning circuit that offsets wear of the inserts, so that maximum efficiency is ensured at all times. The handpiece, which can be autoclave sterilised at 135°C, has a titanium resonator and Is unbreakable. The piezosmart can use the (optional) Starlight p curing lamp for dental composites. The lamp is connected to the scaler cord. The device recognises attachment of the lamp automatically.

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piezo smart - manual of use and maintenance

00.3 Intended use

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With the appropriate inserts, the following treatments can be carried out:

- endodontics: reaming of canals;

- scaling to remove plaque and calculus from the surfaces of teeth;

- periodontal treatment for scaling and root-planing without damaging the periodontium;

- retrograde microsurgery for ultrasound treatment of the root apex;

- condensation of amalgam and of gutta-percha;

- removal of bridges and crowns;

- burnishing of fillings.

00.4 Safety Requirements

Mectron cannot accept any liability for direct or incidental damage to property or personal injury in the following cases: 1 if the equipment is used for purposes other than that for which it is intended. 2 if the equipment is not used in accordance with all the instructions and requirements described

in this manual.

3 If the wiring system in the room in which the equipment is used does not comply with the ap-

plicable standard and appropriate requirements.

4 If any assembly operations, extensions, settings, alterations or repairs have been carried out

by personnel not authorised by Mectron.

5 If the environmental conditions in which the device is kept and stored to not comply with the

requirements indicated in the charter on technical specifications.

DANGER: Qualified and specialised personnel.

This equipment should be used only by specialised personnel having the appropriate training, The equipment does not produce any side effects if it is correctly used.

DANGER: Intended use.

Use the equipment solely for the purpose for which it is intended (see point “00.3”). Failure to comply with this requirement could lead to serious harm to the patient and/or to the operator and/or damage to or failure of the equipment.

WARNING: Contraindication.

Do not carry out scaling on metal or ceramic prosthetic artefacts. The ultrasonic vibrations could cause decementation of the artefacts.

DANGER: Contraindications.

Do not carry out scaling treatments without spraying water as this could cause overheating of the insert with consequent injury of the tooth. The only treatments that can be carried out without spraying water are those envisaged for “Dry Work” inserts, which are not cannulated.

DANGER: Check the condition of the device before starting the treatment.

Always make sure that there is no water underneath the device. Before each treatment always check that the equipment is in proper working order and that the accessories are efficient. Do not carry out the treatment if any problems are encountered in operating the device. If the problems concern the equipment contact an authorised Service Centre.

DANGER: Breakage and wear of the inserts.

In rare cases the high-frequency oscillations and wear can lead to breakage of an insert. Inserts of which the shape has been altered or that are damaged in any way are liable to break during use. Any such inserts should not be used under any circumstances. The patient should be instructed to breathe through his nose during the treatment so as to avoid ingestion of a fragment of a broken insert.

DANGER: Do not install the equipment anywhere where there is a risk of explosions.

The equipment must not be used in places where there is an inflammable atmosphere (anaesthetic mixtures, oxygen, etc.).

DANGER: Contraindications.

To not use the ultrasonic scaler on patients fitted with pace-makers or other implantable electronic devices. This warning also applies to the operator.

DANGER: Cleaning, disinfection and sterilisation of new or repaired products.

All new or repaired products are delivered in non-sterile conditions. All new or repaired products should therefore be cleaned, disinfected and sterilised before being used for any treatments, following the instructions provided under point “06.0” closely.

DANGER: Infection control.

In order to censure maximum safety for both the patient and the operator, use only accessories that have been cleaned, disinfected and sterilised. Follow the instructions provided under point “06.0” closely.

DANGER: Use only original Mectron accessories and spare parts.

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piezo smart - manual of use and maintenance

01.0 Identication data

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02.0 Testing

01.1 Identification

An exact description of the model and the serial number of the equipment will make it easier for our After-Sale Service to respond quickly and efficiently to your queries. Always provide the above information whenever you contact a Mectron Service Centre.

01.2 Equipment identification plate

Each device has its own identification plate (Fig.1) on which the technical specifications and the serial number are indicated. The identification place is on the bottom of the device. The remaining data are indicated in this manual (see Section 13.0”).

Fig. 1

01.3 Identification place of the scaler handpiece

The serial number of the scaler handpiece is engraved on the grey connector of the handpiece (Fig.2 - Ref.A).

02.1 Testing of the equipment

Each component of all equipment manufactured by MECTRON is thoroughly checked and tested. During the testing procedure the components are subjected to a number of work cycles. The tests highlight any malfunctioning due to faulty components. This procedure ensures proper functioning and reliability of all components.

03.0 Delivery

03.1 Delivery of the device

The equipment contains electronic components that may be damaged by impacts even inside the packaging. Special care must therefore be taken during both transport and storage. To avoid crushing, do not pile cartons one on top of another. All material shipped by MECTRON is checked at the time of shipment. The equipment is delivered properly protected and packaged. Check the equipment upon receipt for possible transport damage. If any damage is found make a complaint to the carrier.

Fig. 2

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piezo smart - manual of use and maintenance

03.2 List of material included in the standard supply

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1 Housing of the device (Fig.3 - Ref.A). 1 Scaler handpiece (Fig.3 - Ref.B). 2 Bottles (Fig.3 - Ref.C) 1 K3 torque wrench (Fig.3 - Ref.D). 1 Kit of 4 inserts.(Fig.3 - Ref.E). 1 Pedal with cable and plug (Fig.3 - Ref.F). 1 Peristaltic pump (Fig.3 - Ref.G). 1 External power supply unit (Fig.3 - Ref.H). 2 Bottle caps (Fig.3 - Ref.I).

This equipment may vary at the time of promotional campaigns.

04.0 Installation

04.1 Safety requirements during installation

DANGER: The wiring system of the premises where the device is installed and used must comply with the applicable standards and with the relevant electrical safety requirements.

DANGER: Do not install the equipment anywhere where there is a risk of explosions. The equipment must not be used in places where there is an inflammable atmosphere (anaesthetic mixtures, oxygen, etc.).

DANGER: Install the device in a place where it will be protected from blows and from accidental sprays of water or other liquids.

DANGER: Do not install the device above or in the vicinity of sources of heat. Make sure that there is sufficient air circulation around the device.

WARNING: The device is transportable, however it must be handled with care when it is moved.

WARNING: Do not expose the device to direct sunlight or to sources of UV light.

Fig. 3

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piezo smart - manual of use and maintenance

04.2 Installation of the peristaltic pump

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WARNING: All activities involving the peristaltic pump must be carried out only after

disconnecting the device from the mains power supply and without installing the bottle of liquid.

1 Turn the device upside down; 2 Plug the short end of the tube of the pump into the connector shown in Fig. 4, Ref.A; 3 Secure the pump to the black base as shown in Fig. 4. It must click audibly into place; 4 Pass the longer end of the tube of the pump through the hole shown in Fig. 4, Ref.B; 5 Plug the tube into the connector shown in Fig. 4, Ref.D.

04.3 Connection of the device

1 Plug the pedal into its socket on the housing of the device (Fig.4 - Ref.F). 2 Plug the power cable into its connector on the housing of the device (Fig.4 - Ref.G), then plug

the other end into the power outlet.

WARNING: Make sure that the voltage and frequency of the mains power supply match

those indicated on the data plate of the external power supply unit.

3 Fasten the pedal and power cables in the cable gland as shown in Fig.4 - Ref.H

Fig. 4

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piezo smart - manual of use and maintenance

A C

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04.4 Preparing the bottle

WARNING: Each bottle can contain up to a maximum of 300 ml.

1 Unscrew the cap from the bottle (Fig.5 - Ref.A); 2 Fill the bottle with the required liquid; 3 Check that the tube on the back of the cap is connected (Fig.5 - Ref.B); 4 Screw the cap onto the bottle (Fig.5 - Ref.C).

04.5 Installing the bottle on the equipment

Fig. 5

WARNING: Make sure that the connection on the bottle is clean and not clogged

(Fig.5 - Ref.D).

WARNING: Make sure that the connection for the bottle on the device is clean (Fig.6 - Ref.E).

WARNING: Make sure that the O-rings on the connection are not damaged (Fig.6 - Ref.E).

1 Holding the bottle at an angle of 45° (Fig.6 - Ref.F), fit it onto the device (Fig.6 - Ref.E) by

means of the coupling on the cap (Fig.5 - Ref.D); 2 Fit the bottle snugly onto the coupling; 3 Turn the bottle downwards into a vertical position (Fig.6 - Ref.F).

04.6 Removing the bottle from the device

WARNING: Do not turn the bottle upside down as the cap is not watertight.

Leaking physiological solution or aggressive liquid may damage surfaces.

1 Turn the bottle upwards until it is tilted by 45° (Fig.6 - Ref.F); 2 Pull off the bottle; 3 To preserve the liquid better, replace the cap fitted with a coupling with another cap that has no

coupling.

E F G

Fig. 6

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piezo smart - manual of use and maintenance

Description of the controls

Ref. A - Set of 2 keys, - and +

Function For setting the flow rate of the peristaltic pump (0-9).

Ref. B - Set of 2 keys, - and + Function For setting the required power level (1-9).

Ref. C - Blue LED Function The LED lights up to signal that the device is powered.

Ref. A/B - Set of 4 keys, - and + Function When the device is off, press this key to switch it on. When the device is on, hold this key down for at least 3 seconds to switch it off,

The other controls on the device are: The pedal (Fig.3 - Ref. F) for enabling operation.

A B C

05.1 Controls

A B C

Fig. 8

Fig. 7

05.0 Use

05.2 Switching on and off

1 Press one of the 4 keys on the front panel; 2 The device will switch on.

1 Press one of the 4 keys on the front panel and hold it down for at least 3 seconds; 2 The device will switch off.

NOTE: If the device is not used for at least 5 minutes i twill switch off automatically.

NOTE: If the device is not switched off correctly, when it is switched on again the message WARNING 35 will appear on the display for a few seconds.

To switch on the device

To switch off the device

05.3 Description of the display and functions

The display shows the current settings of the instrument. After the system check, two bars are shown, as follows:

- The part on the left indicates the output level of the peristaltic pump: “PUMP” (Fig.8 - Ref.A).

- The part on the right indicates the power level of the scaler and the associated level

(Fig.8 - Ref.B).

The device can be used at different power levels for three different functions:

- Levels 1 to 2 ENDO

- Levels 3 to 5 PERIO

- Levels 6 to 9

Use the - and + keys (Fig.7 - Ref.A) to lower or increase the output of the peristaltic pump. The indication on the display will change (Fig.8 - Ref.A).

Use the - and + keys (Fig.7 - Ref.B) to lower or increase the power of the scaler. The indication on the display will change (Fig.8 - Ref.B).

SCALER

This section illustrates the front panel (Fig.7) of the piezo smart, to as to enable immediate identification of the controls described in this manual.

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piezo smart - manual of use and maintenance

05.4 Safety Requirements during use

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05.5 Safety and alarm circuits

DANGER: Contraindications.

Do not use the scaler on patients fitted with pace-makers or other implantable electronic devices. This warning also applies to the operator.

DANGER: Contraindications.

Do not carry out scaling treatments without a water spray as this could cause overheating of the insert with consequent injury of the tooth. The only treatments that can be carried out without a water spray are those for which the “Dry Work” inserts, which are not cannulated, are designed. Ask for a catalogue of Mectron inserts.

DANGER: Breakage and wear of the inserts.

In rare cases the high-frequency oscillations and wear can lead to breakage of an insert. Inserts of which the shape has been altered or that are damaged in any way are liable to break during use. Any such inserts should not be used under any circumstances. In order to avoid ingestion of a fragment of a broken insert, the patient should be instructed to breathe through his nose during the treatment.

DANGER: Infection control.

To ensure maximum safety of both the patient and the operator, clean, disinfect and sterilize the piezoelectric handpiece, the inserts and torque wrench after each treatment. Follow the instructions on this subject container in Section 06.0 “CLEANING, DISINFECTION AND STERILISATION”.

WARNING: Contraindication.

Do not carry out treatment for removing calculus on metal or ceramic prosthetic artefacts as the ultrasound vibrations could cause decementation of the artefacts.

WARNING: Contraindication.

Wait for the handpiece to cool down completely before using it again after it has been autoclave sterilised.

WARNING: The electric contacts inside the handpiece and cord connectors must be dry.

Before connecting the handpiece to the cord make sure that the electric contacts of both connectors are perfectly dry. This is a particularly important check after an autoclave sterilisation cycle. If necessary, dry the contacts by blowing air onto them with the syringe.

WARNING: After using aggressive solutions it is necessary to carry out a cleaning cycle of the tube and of the handpiece with distilled water, using the Clean function (See point 06.1). If this is not done, the salts may crystallise and seriously damage the device.

WARNING: Use cannulated inserts only to carry out treatments requiring a spray.

WARNING: For a correct use of the device it is necessary to press the pedal and start the

device without placing the insert on the part to be treated. This will enable the electronic circuit to recognise the best point of resonance of the insert without interferences, so as to achieve optimum performance. Contact with the part to be treated or with other surfaces before starting the device could cause the tripping of the safety circuits.

The device has a diagnostic circuit enabling tripping of the safety and alarm systems to be recognised. They are signalled on the display.

WARNING 1 General safety circuit tripped:

- Scaler handpiece not connected to the device;

- Improper functioning of the tuning circuit;

- Handpiece failure.

WARNING 2 General safety circuit tripped:

- Scaler handpiece not connected to the device;

- Improper functioning of the tuning circuit;

- Handpiece failure.

WARNING 4 General safety circuit tripped:

- Improper functioning of the tuning circuit;

- Handpiece failure.

WARNING 5 Tuning scan failed:

- Insert not properly tightened onto the handpiece;

- Insert worn, broken or deformed;

- The electric contacts of the cord and/or of the handpiece are wet;

- Overheating of handipece.

WARNING 6 Power supply voltage out of range.

WARNING 16 Error in communications with the scaler module:

- The device switches off. Contact the Mectron Service Centre immediately.

WARNING 17 Pump operational error:

- Check that the pump and the tube are properly installed;

- Make sure that there is nothing preventing the pump from turning.

WARNING 18 Pump operational error:

- Contact the Mectron Service Centre.

WARNING 19 Scaler module initialisation error:

- The device switches off. Contact the Mectron Service Centre immediately.

WARNING 21 Checksum error, modification of scaler module firmware:

- The device is working properly. Contact the Mectron Sertice Centre as soon as possible;

- The device is not working properly. Contact the Mectron Service Centre immediately and in the meantime do not use the device.

WARNING 22 Checksum error, modification of mainboard firmware:

- The device is working properly. Contact the Mectron Sertice Centre as soon as possible;

- The device is not working properly. Contact the Mectron Service Centre immediately and in the meantime do not use the device.

WARNING 26 Voltage low safety circuit tripped:

- The device switches off. Disconnect the power supply unit from the power outlet and contact the Mectron Service Centre immediately.

WARNING 27 Voltage high safety circuit tripped:

- The device switches off. Disconnect the power supply unit from the power outlet and contact the Mectron Service Centre immediately.

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piezo smart - manual of use and maintenance

WARNING 35 Abnormal switching off procedure:

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- The switching off procedure was not carried out correctly the last time the device was used;

- The device switched off during use due to outside interference.

06.0 Cleaning, disinfection and sterilisation

06.1 CLEAN Function - Cleaning of the liquid circuit

05.6 Instructions for use

1 Connect the scaler handpiece to the cord, after checking that the electric contacts on both are

perfectly dry. If necessary, dry the contacts by blowing air onto them with the syringe. 2 Screw the chosen insert onto the scaler handpiece until it fits closely (Fig. 9 - Ref.A). 3 Use the torque wrench included in the supply to tighten the insert. To use the torque wrench correctly (Fig.9 - Ref.B) proceed as follows: Hold the housing of the handpiece firmly;

WARNING: Do not grip the handpiece by the end part and/or by the cord, but only on the

plastic housing (Fig.9 - Ref.C), and do not turn it while tightening the insert.

- Turn the torque wrench in a clockwise direction until the clutch engages (the outer body of the

wrench slides in relation to the housing of the handpiece).

- The insert is now properly tightened. 4 Select the required power level by means of the two - and + keys (Fig.7 - Ref.B):

- From 1 to 2 ENDO

- From 3 to 5 PERIO

- From 6 to 9 SCALER. 5 Select the required speed of the peristaltic pump by means of the two - and + keys

(Fig.7 - Ref.A):

- 0 treatment without liquid;

- from 1 to 9 treatment with liquid. 8 The device has a sophisticated electronic circuit enabling the scaler to offset wear of the insert

so as to keep the efficiency of the ultrasound generator constantly high. 9 Upon completing the treatment place the scaler handpiece back in its holder. 10 With this device it is possible to use the Starlight p (optional), a curing lamp for dental

composites. The device recognised insertion of the “Starlight p” automatically when it is set to

a power level between 3 and 9 (Fig.7 - Ref.C). For correct use, consult the User and Mainte-

nance manual of the “Starlight p”.

NOTE: When you stop using the piezo smart, switch off the device as indicated under point 05.2.

A BC

The device has a CLEAN function (See Section 05.3) that enables a cleaning cycle to be carried out on the hydraulic circuit. This function should be used after using the device, before cleaning, disinfecting and sterilising all the parts (see below).

WARNING: If the circuit is not cleaned, salts may crystallise in it and could seriously damage

the device.

1 Replace the bottle with one containing water (demineralised water is recommended). 2 Place the handpiece over a bowl to collect the liquid that will come out during the cleaning

cycle.

3 To activate the CLEAN function, use the “-“ key to set the power level to less than 1

(Fig.7 - Ref.B). The wording “clean” and the associated status bar will appear on the display (Fig.8 - Ref.C).

NOTE: If you have selected the Clean function by mistake, press the “+“ key below the wording

“esc”. 4 Fit one of the inserts used during treatment onto the handpiece. 5 Press the pedal briefly to start the cleaning cycle. As soon as the peristaltic pump starts, a

status bar will appear on the display, and will increase to indicate the time to completion of

the CLEAN cycle. You can stop the cycle by pressing the pedal again or the “+“ key below the

wording “esc”. 6 When the Clean cycle has been completed, the device exits the CLEAN function and returns to

the function that was set previously. 7 Repeat the above steps from point 2 to carry out a cleaning cycle on the tubes and all the

accessories used, such as:

- handpieces (check that the electric contacts of the connector on the cord of accessory to be

subjected to the cleaning cycle are dry);

- inserts. 8 After the cleaning operations, empty the tubes and dry the accessories that have undergone

cleaning.

06.2 Cleaning and disinfecting the housing of the device

DANGER: Switch off the device.

Always switch off the device and unplug it from the power outlet before carrying out the following cleaning, disinfection and sterilisation activities.

DANGER: The housing of the device is not protected against the penetration of liquids. Do not

spray any liquids directly onto the surface of the housing of the device.

Fig. 9

05.7 Checking the inserts for wear

1 Check the insert regularly for wear and replace it if a drop in performance is noted. 2 Do not alter the shape of the insert in any way by bending or filing it. 3 Replace the insert if it has become deformed or received blows. 4 If the insert becomes excessively worn, the scaler will stop working as the APC circuit will be

tripped (see Section”05.3”).

DANGER: The device cannot be sterilised.

After each treatment, proceed as follows: 1 Remove the insert from the scaler handpiece. 2 Clean and disinfect the surfaces of the housing, the cords and the connectors using a cloth

moistened with a mild detergent or disinfectant solution with a neutral pH (pH7). Follow

carefully the instructions provided by the manufacturer of the disinfectant solution. Allow the

disinfectant solution to dry in air before using the device.

NOTE: Water-based disinfectant solutions with a neutral pH are highly recommended. Some alcohol-based disinfectants may be harmful, discolour and/or damage plastic materials.

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piezo smart - manual of use and maintenance

06.3 Sterilisation procedure

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06.5 Autoclave sterilisation of the inserts

WARNING: Sterilisation must be carried out using a steam autoclave only.

Do not use any other sterilisation procedure (dry heat, radiation, ethylene oxide, gas, low-temperature plasma, etc..).

DANGER: Infection control - Sterilisable parts.

To avoid bacterial and virus infections, always clean, disinfect and sterilise the following components after each treatment: 1 Handpieces; 2 Inserts; 3 Torque wrench for tightening the inserts. These components are made of materials able to withstand a maximum temperature of 135°C for a maximum of 20 minutes. The autoclave sterilisation process must be carried out using either of the following parameters:

- Cycle at 121°C for 16 minutes;

- Cycle at 134°C for 4 minutes. All the stages of sterilisation must be carried out by the operator in accordance with EN 554 and EN 556 standards.

06.4 Autoclave sterilisation of the handpiece

WARNING: Do not dip the handpiece into disinfectants or other types of liquid as this

could cause damage to it.

WARNING: Do not sterilise the handpiece with an insert fitted in place.

WARNING: The electric contacts of the handpiece connector and of the cord connector

must be dry.

Upon completion of the sterilisation cycle and before connecting the handpiece to the cord, make sure that the electric contacts of both connectors are perfectly dry. If necessary, dry the contacts by blowing air on them with the syringe.

WARNING: Allow the handpiece to cool completely after a sterilisation cycle before using

it again.

1 Clean the handpiece carefully, paying special attention to the threaded pin onto which the

inserts are screwed and tiio the adjacent ring-shaped cavity.

2 Disinfect the handpiece using a cloth moistened with a mild disinfectant solution with a neutral

pH. 3 Dry the electric contacts by blowing air onto them with the syringe. 4 Place the single handpiece (without any inserts) inside a disposable bag and seal it. 5 Sterilise the handpiece in the autoclave.

1 Clean each insert (preferably in an ultrasound tank) and rinse with distilled water. 2 Dry the insert. 3 Disinfect the insert using a mild disinfectant solution with a neutral pH and dry it thoroughly .

WARNING: Before starting the sterilisation cycle, make sure that the insert is completely

dry also internally. To do this, blow air through the hollow part with the syringe. This will prevent stains or patches from appearing on the surface of the insert. 4 Place the inserts in separate disposable bags and seal them. 5 Sterilise the inserts in the autoclave.

06.6 Autoclave sterilisation of the torque wrench for tightening the inserts

1 Clean the wrench. 2 Disinfect the wrench using a mild disinfectant solution with a neutral pH and dry it thoroughly. 3 Place the wrench in a disposable bag on its own and seal the bag. 4 Sterilise the wrench in the autoclave.

07.0 Scheduled maintenance

07.1 Cleaning of the water circuit

1 The device has a Clean function for cleaning the water circuit (see point 06.1). Press the pedal and hold it down for the time considered most suitable for completing the cleaning

cycle. 2 The cleaning cycle can be carried out with or without the handpiece and the insert fitted. 3 Empty the residual water from the circuits by removing the bottle and operating the device for a

few seconds. 4 If the cleaning cycle has been carried out without the handpiece, it is important to dry the elec-

tric contacts of the cord by blowing air onto them with the syringe before starting any applica-

tion.

07.2 External power supply unit

DANGER: Check the housing and the cables of the external transformer periodically to make

sure that they are intact. If it is damaged, replace it with a Mectron original spare.

07.3 Replacement of the peristaltic pump

WARNING: Before carrying out any activities on the peristaltic pump, it is necessary to:

- Remove the bottle (see point 04.6);

- Empty the water circuit by operating the device. Any residues of liquid could accidentally pen-

etrate inside the device.

1 Disconnect the tubes of the peristaltic pumps from their couplings. 2 Press the two side tabs (Fig.4 - Ref. C) and pull out the body of the pump. 3 Insert the new pump following the instructions under point 04.2.

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piezo smart - manual of use and maintenance

08.0 Procedures for disposal and precautions

�

10.0 Trouble-shooting

- The device must be disposed of and treated as waste for separate collection;

- The purchaser may return the device at the end of its working life to the dealer supplying a new device. Instructions for disposal are available from Mectron S.p.A.;

- Failure to comply with the above instructions could lead to application of a penalty in accordance with Directive 2002/96/EC.

DANGER: Hospital waste.

The following must be treated as hospital waste:

- Inserts, when worn or broken;

- Wrench for tightening the inserts, if worn or broken.

09.0 Inserts for Mectron scaler and how to use them

S1 - S2 - S3 - S4 - S5: For general use in scaling; S6 - S7 - S8: High-efficiency, for general use in scaling for removing large quantities of calculus; P1 - P2 - P3 - P4: For general use in removing concretions from root surfaces; P10 - P11 - P12 - P13 - P14: For general use in removing concretions from deep root surfaces; R1 - R2 - R3 - R4 - R5: For general use in retrograde root canal treatment; D1 - D2 - D3 - D4: For general use in condensing amalgam - burnishing fillings - lateral condensa-

tion of gutta-percha - removal of crowns, bridges and pins;

CM1 - CM2 - CM3 - CM4: For marginal finishing; ER1 - ER2 - ER3 - ER4 - ER5: For general use in orthograde endodontics; E1 - E2: Holder for 120° or 90° files, for endo files.

If the device does not seem to be working correctly, read the instructions again and then check the following table.

PROBLEM POSSIBLE CAUSE SOLUTION

The device will not switch on. The blue LED is off (Fig.7

- Rif.G).

The device is switched on but will not work.

A slight hissing noise is made by the scaler handpiece while it is working.

One of the following wordings appears in the display:

WARNING 1 WARNING 2 WARNING 4.

The power supply unit is not properly connected to the mains outlet or to the device.

The power supply unit and/or is out of use or ’the internal fuse is blown.

The pedal is not properly plugged into its socket.

The pedal is out of order.

The insert is not properly tightened onto the scaler handpiece.

Scaler handpiece not connected to the device.

Improper functioning of the tuning circuit.

Make sure that the power supply unit is properly connected. Check that the power outlet is in proper working order.

Contact an authorised MECTRON Service Centre.

Plug the pedal in correctly.

Contact an authorised MECTRON Service Centre.

Unscrew the insert and screw it back into place correctly.

Check whether the handpiece is properly connected to its cord.

Contact an authorised MECTRON Service Centre.

Handpiece failure.

The message WARNING 35 appears on the display for a few seconds.

The switching off procedure was not carried out correctly after the last time it was used.

The device switched off during use due to an external interference.

Contact an authorised MECTRON Service Centre.

Switch the device off correctly. See point 05.2.

Consult the tables under point

12.1.

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piezo smart - manual of use and maintenance

PROBLEM POSSIBLE CAUSE SOLUTION

�

0476

PROBLEM POSSIBLE CAUSE SOLUTION

The following wording appears on the display:

WARNING 5.

One of the following wordings appears on the display:

WARNING 6 WARNING 26 WARNING 27.

One of the following wordings appears on the display:

WARNING 16 WARNING 19 WARNING 26 WARNING 27.

The insert is not properly tightened onto the scaler handpiece.

Insert worn, broken or deformed.

The electric contacts of the cord or of the handpiece are wet.

Handpiece overheated.

Power supply voltage out-ofrange safety circuit tripped.

The device switches off. Contact an authorised

Unscrew the insert and screw it back into place correctly.

Replace the insert.

Switch off the device, dry the contacts of the cord and of the handpiece with compressed air.

Wait for it to cool down. To speed up cooling carry out a cleaning cycle (after removing the insert it is of the dry work type).

Contact an authorised MECTRON Service Centre.

MECTRON Service Centre.

No water comes out of the insert during operation.

The insert is not of the cannuled type.

The pump output is on zero.

The bottle for the liquid is empty.

The bottle containing the liquid is not correctly installed.

The tubes of the pump are not correctly installed.

The insert is clogged.

The handpiece is clogged.

Use a cannulated insert.

Increase the output of the pump.

Replace the bottle with a full one.

See points 04.6 and 04.5.

Check the connections of the tubes.

Unstop the insert to allow the passage of water.

Contact an authorised MECTRON Service Centre.

11.0 Symbols

N.B.: Please read carefully the instructions for use.

Class II apparatus.

The following wording appears on the display:

WARNING 17.

The following wording appears on the display:

WARNING 18.

Checksum error. Modification of the firmware. One of the following wordings appears on the display:

WARNING 21 WARNING 22.

Pump operational error. Check whether the pump

Pump operational error. Contact an authorised

The device is in proper working order.

The device is not in proper working order.

and the tube are correctly installed. Make sure there is nothing preventing the pump from turning.

MECTRON Service Centre.

Contact an authorised MECTRON Service Centre as soon as possible.

Disconnect the power-supply unit from the mains outlet and contact an authorised MECTRON Service Centre immediately.

Type “B” applied part.

This device and its accessories shouldn’t be disposed or treated as solid urban waste.

The sterilisable materials must be autoclave sterilised and can withstand a maximum temperature of 135° C.

Apparatus in accordance with EC Directive 93/42 EEC Including EN 60601-1 and EN 60601-1-2. Notified body: CERMET

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piezo smart - manual of use and maintenance

12.0 Technical specications

This device complies with Directive 93/42/EEC: Class II a.

Classification in accordance with EN 60601-1: II Type B IP 20 (device) IP 20 (power-supply unit) IP 22 (pedal)

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

Voltage required by the external power-supply unit: Mectron - Model AC/DC adapter

- from 100 to 240 Vac ± 10 % 50/60 Hz.

Voltage required by the device: 33 VDC ± 10 %

Max. power absorbed: 40 VA

Internal fuse: Type 5 X 20 mm 1 X 2 A T.

Working frequency: Automatic scanning. From 24 to 29.5 KHz.

Power: Adjustable in 9 pre-set steps:

From 1 to 2 ENDO From 3 to 5 PERIO From 6 to 9 SCALER

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

Transport and storage conditions: From -10°C to +70°C. Relative humidity from 10% to 90%. Air pressure P: 500hPa/1060hPa

Weight and measurements: 0.92 Kg L - W - H 228 x 146 x 146 mm

12.1 Electromagnetic compatibility EN 60601-1-2

Guidance and manufacturer’s declaration - Electromagnetic emissions

The PIEZO SMART is intended for use in the electromagnetic environment specified below. The customer or the user of the PIEZO SMART should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - Guidance

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations / flicker

emissions

IEC 61000-3-3

Group 1 The PIEZO SMART uses RF energy only for its internal

Class B The PIEZO SMART is suitable for use in all establishments,

Class A

Complies

function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Output of the peristaltic pump: Adjustable in 10 steps from 0 to 9 From 25 to 55 ml/min approx.

Safety devices and time to tripping of the APC circuit:

- No handpiece connected Tripping time 20 ms.

- Cord interrupted Maximum tripping time 80 ms.

- Insert broken or not correctly tightened Three scans, 150 ms each

- Protection by discharge to earth Tripping time 20 ms

Alarms: A warning appears on the front-panel display Se sections: ”Safety and alarm circuits” “Troubleshooting”

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piezo smart - manual of use and maintenance

Guidance and manufacturer’s declaration - Electromagnetic immunity

The PIEZO SMART is intended for use in the electromagnetic environment specified below. The customer or the user of the PIEZO SMART should assure that it is used in such an environment.

Immunity test IEC 60601

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

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

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

NOTE: UT is the a.c. mains voltage prior to application of the test level.

test level

±6 kV contact ±8 kV air

±2 kV for power supply lines

±1 kV for input/output lines

±1 kV differential mode ±2 kV common mode

<5 % UT (>95 % dip in UT) for 0,5 cycle

40 % UT (60 % dip in UT) for 5 cycle

70 % UT (30 % dip in UT) for 25 cycle

<5 % UT (>95 % dip in UT) for 5 s

3 A/m 3 A/m Power frequency

Compliance level Electromagnetic envi-

±6 kV contact ±8 kV air

±2 kV for power supply lines

±1 kV for input/output lines

±1 kV differential mode ±2 kV common mode

<5 % UT (>95 % dip in UT) for 0,5 cycle

40 % UT (60 % dip in UT) for 5 cycle

70 % UT (30 % dip in UT) for 25 cycle

<5 % UT (>95 % dip in UT) for 5 s

ronment - 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.

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

Guidance and manufacturer’s declaration - Electromagnetic immunity

The PIEZO SMART is intended for use in the electromagnetic environment specified below. The customer or the user of the PIEZO SMART should assure that it is used in such an environment.

Immunity test IEC 60601 test level

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

Notes: (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 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 PIEZO SMART is used exceeds the applicable RF compliance level above, the PIEZO SMART should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the PIEZO SMART.

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

3 Veff 150 kHz to 80 MHz

3 V/m 80 MHz to 2,5 GHz

Complian-

ce level

3 Vrms

3 V/m

Electromagnetic environment - Guidance

Portable and mobile RF communications equipment should be used no closer to any part of the disposal 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 80 MHz to 800 MHz d = 2,3 √P 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,a should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

Page 16

piezo smart - manual of use and maintenance

Recommended separation distances between portable and mobile RF communications equipment

The PIEZO SMART is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PIEZO SMART can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PIEZO SMART 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 estimated 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. Note: (1) At 80 MHz and 800 MHz, the separation distance for 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.

150 kHz to 80 MHz

and the PIEZO SMART

Separation distance according to frequency of transmitter “m”

d = 1,2 √P

80 MHz to 800 MHz

d = 1,2 √P

800 MHz to 2,5 GHz

d = 2,3 √P

13.0 Warranty

Before being placed on the market, all MECTRON equipment undergoes a thorough final check to ensure that it is are in proper working order. MECTRON warrant their products, purchased brand-new from authorised MECTRON dealers or importers, free from material or manufacturing defects for a period of 2 (two) years from the date of purchase. Throughout the warranty period, MECTRON undertake to repair (or, at their sole discretion, to replace) free of charge any parts that, in their opinion, are faulty. Complete replacement of MECTRON products is excluded. Mectron cannot accept any liability for direct or incidental damage or personal injury in the following cases:

- If the equipment is used for purposes other than that for which it is intended.

- If the equipment is not used in accordance with all the instructions and requirements described in this manual.

- If the wiring system in the room where the equipment is used does not comply with the applicable standards and appropriate requirements.

- If any assembly operations, extensions, settings, alterations or repairs have been carried out by personnel not authorised by Mectron.

- If the environmental conditions in which the device is kept and stored do not comply with the requirements indicated in the chapter on technical specifications.

Accidental damages due to transport, incorrect use or carelessness or to connection to power supplies other than as envisaged and damage to the signalling lamps, handpieces and all accessories are excluded from the warranty. The warranty will no longer apply if the apparatus has been tampered with or repaired by unauthorised personnel.

WARNING

The warranty is valid only if the warranty slip enclosed with the product has been completed in full and returned to us or, if appropriate, to your MECTRON dealer or importer within 20 (TWENTY) DAYS from the date of purchase, as proven by the consignment note/invoice issued by the dealer / importer. In order to benefit from the warranty service, the customer must return the apparatus to be repaired to the MECTRON dealer/importer from which it was purchased, at his own expense. The apparatus should be returned suitably packed (possibly in its original packing material), accompanied by all the accessories and by the following information:

a) Owner’s details, including his telephone number. b) Details of the dealer/importer. c) Photocopy of the consignment note / purchase invoice of the apparatus issued to the owner

and indicating, in addition to the date, also the name of the apparatus and its serial number.

d) A description of the problem.

Transport and any damages caused during transport are not covered by the warranty. In the event of failures due to accidents or improper use, or if the warranty has lapsed, repairs to MECTRON products will be charged on the basis of the actual cost of the materials and labour required for such repairs.

Page 17

Rivenditore - Reseller - 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]

Rev. 02 del 24-07-2007

piezo smart V. GB