mectron piezo smart Instruction manual

English
Manual of use and maintenance
0476
piezo smart

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piezo smart - manual of use and maintenance
00.0 Introduction
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)
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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.
Summary
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

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piezo smart - manual of use and maintenance
00.3 Intended use
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.
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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.
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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.
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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.
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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, fol-
lowing the instructions provided under point “06.0” closely.
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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.
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DANGER: Use only original Mectron accessories and spare parts.
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WARNING: Contraindication.
Do not carry out scaling on metal or ceramic prosthetic artefacts. The ultrasonic vibrations could
cause decementation of the artefacts.
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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.
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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.).

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piezo smart - manual of use and maintenance
01.0 Identication data
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”).
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).
02.0 Testing
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 A
Fig. 1
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piezo smart - manual of use and maintenance
03.2 List of material included in the standard supply
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.
B
A
C
D
E
F
H
G
Fig. 3
I

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piezo smart - manual of use and maintenance
04.2 Installation of the peristaltic pump
�
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
E
H
GF
Fig. 4
A
B
B
C
D

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piezo smart - manual of use and maintenance
A C
B
Fig. 5
04.4 Preparing the bottle
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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
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WARNING: Make sure that the connection on the bottle is clean and not clogged
(Fig.5 - Ref.D).
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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.
Fig. 6
D
E F G

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piezo smart - manual of use and maintenance
05.0 Use
05.1 Controls
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.
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.
05.2 Switching on and off
To switch on the device
1 Press one of the 4 keys on the front panel;
2 The device will switch on.
To switch off the device
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.
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 SCALER
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).
A B C
Fig. 7
Fig. 8
A B C

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piezo smart - manual of use and maintenance
05.4 Safety Requirements during use
�
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 connec-
tors 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.
05.5 Safety and alarm 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:
- 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.
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.
06.0 Cleaning, disinfection and sterilisation
06.1 CLEAN Function - Cleaning of the liquid circuit
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.
�
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.
A BC
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”).