mectron COMPACT PIEZO LED User manual

INSTALLATION MANUAL
compact piezo LED
U.S. Federal law restricts this device to sale by or on the order of a licensed dentist or dental hygienist.
00510051

COMPACT PIEZO LED

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Copyright
© Mectron S.p.A. 2022. All rights reserved. No part of this document can be reproduced in any
form without the written consent of the copyright owner.

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COMPACT PIEZO LED
TABLE OF CONTENTS
1 Introduction 1
1.1 Intended Use 1
1.2 Description of the Device 2
1.3 Disclaimer 2
1.4 Safety Precautions 3
1.5 Symbols 5
2 IdenticationData 6
2.1 DeviceIdenticationLabel 6
2.2 HandpieceIdenticationData 7
2.3 InsertTipsIdenticationData 7
3 Delivery 8
3.1 List of Components 8
4 Installation 11
4.1 Safety precautions During Installation 11
4.2 Mechanical Installation 12
4.3 Electrical Connections 13
4.3.1 Alternate 24V Power Supply 14
4.3.2 Direct 32V Power Supply 14
4.3.3 Power Regulation 15
4.3.3.1 Power Regulation with 2.2 kOhm Potentiometer 15
4.3.3.2 Power Regulation with 10 kOhm Potentiometer 15
4.3.3.3 PowerRegulationwith4.7kOhmPotentiometer 15
4.3.3.4 0-5VPowerRegulation 16
4.3.3.5 0-10VPowerRegulation 16
4.3.4 SolenoidValveControl 16
4.3.5 Enabling 17
4.3.5.1 EnablingofPedalwithNegativeSignal 17
4.3.5.2 EnablingofPedalwithPositiveSignal 17
4.3.6 OtherConnections 17
4.3.7 ConnectingtheCordoftheScalerHandpiece 18
4.3.8 Standard Connections 18
4.3.8.1 Layout A 19
4.3.8.2 Layout B 19
4.3.8.3 Layout C 20
4.3.8.4 Layout D 20
4.3.8.5 Layout E 21
4.3.8.6 LayoutF 21
4.3.8.7 LayoutG 22
4.3.8.8 Layout H 22
4.4 Water Connection 23
5 MethodsandPrecautionsforDisposal 24
6 TechnicalData 24
6.1 ElectromagneticCompatibilityIEC/EN60601-1-2 26
6.1.1 GuidanceandManufacturer’sDeclaration-ElectromagneticEmissions 26
6.1.2 AccessiblePartsoftheCasing 27
6.1.3 GuidanceandManufacturer’sDeclaration-ElectromagneticImmunity 28
6.1.3.1 A.C.InputPowerConnection 28
6.1.3.2 PointsofContactwiththePatient 30
6.1.3.3 PartsAccessibletotheInput/OutputSignals 31
6.1.4 SpecicationsoftheTestsfortheImmunityoftheAccessiblePartsofthe

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CasingtotheWirelessRFCommunicationsDevice 32
7 Troubleshooting 33
7.1 DiagnosticSystem 33
7.2 TroubleshootingQuickGuide 34
7.3 CustomerService-Returnsand/orRepairs 36
7.3.1 Repairs 36
7.3.2 ReturnedGoods 36
8 Warranty 37

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COMPACT PIEZO LED
PAGEINTENTIONALLYLEFTBLANK

1
INTRODUCTION
1 INTRODUCTION
1 https://manuals.mectron.com/
Read this manual and follow its instructions
carefully before proceeding with the
installation, use, maintenance, or other
operations on the device. Please always keep
this manual within easy reach.
IMPORTANT: to avoid potential serious
injurytotheuserandthepatientand/
or this device or other equipments, read
all the “Safety precautions” present in the
manual with particular attention. The words
WARNING, CAUTION and NOTE contained
in this document, carry special meaning
and must be carefully reviewed. Depending
on their degree of seriousness, the safety
precautionsareclassied:
WARNING:(Identiesconditionsor
practices that present a risk of serious injury
ordeathtothepatientand/ortheuser.)
CAUTION:(Identiesconditionsor
practices that could result in minor injury or
devicedamage.)
NOTE:Identiesspecialinformationtoclarify
or emphasize important instructions.
The purpose of this manual is to make
the operator knowledgeable of the safety
precautions and the instructions for a correct
installation and maintenance of the device
and its accessories.
Use of this manual for purposes other than
those strictly tied to the installation 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 modications to
device components.
In case you encounter discrepancies between
the descriptions found in this manual and the
device in your possession you can:
• check for any available updates in
the section MANUALS of MECTRON
website
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;
• askclaricationstoYourDealer;
• contact Piezosurgery Inc. After Sales
Service.
1.1 IntendedUse
The compact piezo LED is an ultrasonic piezoelectric scaler intended for use, with the appropriate
associated insert tips, in the following dental applications:
• Scaling: Procedures for removal
ofsupra-gingival/sub-gingivaland
interdentalcalculus/plaquedeposits;
• Periodontology: Periodontal therapy
and debridement for all types of
periodontal diseases, including
periodontal pocket irrigation and
cleaning;
• Endodontics: All treatments for root
canal reaming, irrigation, revision,
lling,guttaperchacondensationand
retrograde preparation;
• RestorativeandProsthetics:
Restorative procedures including cavity
preparation, removal of prostheses,
amalgamcondensation,nishing
ofcrownpreparations,inlay/onlay
condensation,implants/restorations
cleaning.
WARNING: The device must be used
in a dental practice, in a clinic, or in a
professional oral hygiene and preventive
care centres. Do not use the device in
environments where the atmosphere
issaturatedwithammablegases
(anaestheticmixtures,oxygen,etc.).

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COMPACT PIEZO LED
WARNING: Qualiedandspecialized
personnel.The device is intended exclusively
for use by a dentist, or dental hygienist, with
suitablemedical/healthtraining.The use of
thedevicedoesnotcausesideeectsifitis
used correctly. An improper use might cause
tissues heating.
WARNING: IntendedUse. 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.
1.2 DescriptionoftheDevice
compact piezo LED is a multifunctional
ultrasonic piezoelectric scaler. It has been
designed in order to oer 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 tip, so that the best
performance is always assured. The handpiece
has a circular LED light and can be autoclaved
at 135 °C.
1.3 Disclaimer
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:
• Useorproceduresdierentthanthose
speciedintheintendeduseofthe
product;
• The environmental conditions for the
preservation and storage of the device
are not compliant to the precautions
indicated in the Chapter6onpage24 ;
• The device is not used in compliance
with 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 repairs on the
device are performed by personnel not
authorized by Piezosurgery Inc.;
• Misuse, abuse, abnormal use, negligent
use, intentional misconduct or use
exceeding the limits of the device
indicatedandallowedand/ornormal
wearordeterioration,illtreatmentand/
or incorrect interventions;
• Any and all attempts to tamper with
or modify the device, under any
circumstance;
• Use of non-original Mectron insert
tipsthatentailanitedamageto
the threading of the handpiece, thus
compromising correct operation and
causing risk of harm to the patient;
• Use of non-original Mectron insert tips,
used in accordance to designed and
tested settings of Mectron original insert
tips. The correct use of the settings is
guaranteed only with original Mectron
insert tips;
• Lack of stock materials (handpiece,
inserttips,wrenches)tobeusedinthe
event of device stop due to fault or of
inconveniences;
• Incorrect/omittedmaintenance
compared to what is stated in Chapter7
on page 33 of this manual;

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INTRODUCTION
• Breach of the requirements and the
information contained in Chapter 4.5 on
page 14 of the Use and Maintenance
Manual;
• Breach of the requirements and the
information contained in Chapter6on
page 17 of the Use and Maintenance
Manual;
• Unauthorized repairs in accordance with
the indications contained in Chapter7.3
on page 36 of this manual.
1.4 SafetyPrecautions
WARNING: Contraindications.
Do not use the device on patients who
carryheartstimulators(Pace-makers)or
other implantable electronic devices. This
precaution also applies to the operator.
WARNING: Contraindications. Do not
perform scaling treatments without water
spray in order to avoid the insert tip over-
heating which may cause damages to the
tooth. Treatments with no water spray can be
carried out only with “Dry Work” insert tips
which do not have the water passage.
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.
Interferencefromotherequipment.
An electrical scalpel or other electro-surgical
units near the compact piezo LED device may
interfere with its correct operation.
WARNING: Contraindications.
Interferencewithotherequipment.
ThoughcomplianttothestandardIEC60601-
1-2, compact piezo LED may nonetheless
interfere with other devices nearby.
compact piezo LED must not be used near
to or stacked on other devices. However,
if this were to prove necessary, check and
monitor correct operation of the device in
thatconguration.
WARNING: Riskofexplosion. The
device cannot operate in environments where
theatmosphereissaturatedwithammable
gases(anestheticmixtures,oxygen,etc..).
CAUTION: In case 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thestandardEN62353
‘Medical electrical equipment - Periodic
inspections and tests to be carried out after
repairofmedicalelectricalequipment’.The
frequency of periodic inspections in the
intended conditions of use described is
once per year or every 2000 hours of use,
whicheverconditionissatisedrst.
WARNING: Checkingdevicestatus
beforethetreatment. Before every
treatment, always check that the device
works perfectly and that the accessories are
ecient.Incaseofoperatingabnormalities,
DO NOT perform the treatment. Contact an
Authorized Piezosurgery Inc. Service Center if
the abnormalities concern the device.
WARNING: Cleaningandsterilising
neworrepairedinstruments. All the new
or repaired device accessories are not sterile.
Atrstuseandaftereachtreatmentthey
must be cleaned and sterilized by carefully
following the instructions in Chapter6on
page 17 of the Use and Maintenance
Manual.
WARNING: Diamond coated insert tips
are SINGLEUSEONLY. The diamond coated
insert tips are intended to be used on an
individual patient during a single treatment
procedure and then disposed of. The
diamond coated insert tips must be sterilized
onlyonetime,priortherstuse.

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COMPACT PIEZO LED
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
rstcleanedandsterilizedthem,following
the instructions of the Chapter6onpage
17 of the Use and Maintenance Manual.
CAUTION: Contraindications. Allow
reusable, autoclavable items (the handpiece,
the insert tips, 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.
WARNING: Breakageandwear-outof
the insert tips. High frequency oscillations
and wear-out may, in rare circumstances, lead
to the breakage of the insert tip.
Deformed or otherwise damaged insert tips
are susceptible to breakage during their use.
These insert tips must never be used.
If an insert tip breaks, check that none of its
fragments remain in the treated part and,
atthesametime,applyeective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
insert tips.
Check the level of wear of the insert tip and
its integrity before and during each use. If
there is a decrease in performance, replace
it. The level of wear of the most common
inserttips(S1,S1-S,S2,S5,P2,P4,P10)can
be checked by using the INSERT TIP - CARD
supplied. To use the INSERT TIP - CARD
correctly:
• Position the insert tip on the INSERT
TIP-CARDsothattheprolematches
theoneprintedonthecard.Theprole
printed on the card has a red line
indicating the wear limit;
• If the insert tip has a length less than
the wear limit, its performance will be
signicantlylowerthanthecondition
of a new one and replacement is
recommended.
If the layer of titanium nitride (golden
surface),wherepresent,isvisiblyworn,the
insert tip must be replaced. The use of a worn
inserttipdecreasesitseciency.
When the nitride coating wears out, the
cuttingeciencydecreases;re-sharpening
the insert tip damages it and is therefore
forbidden. Check that the insert tip is not
worn out.
During the intervention, frequently check that
the insert tip 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 insert tips during their use.
WARNING: OnlyuseoriginalMECTRON
inserttips,accessories,andspareparts.
CAUTION:Nomodicationofthis
equipment is allowed.
WARNING: Prior to any use, system
components must be inspected for damage.
Do not use if damage is apparent.
WARNING: Do not operate the device if
handpiece is defective, damaged or broken.
Immediately replace the handpiece.
NOTE: In case of accident attributable to the
device during correct use and in accordance
with the intended use, a report must be
made to the Competent Authority and
manufacturer indicated on the product label.