mectron PIEZOSURGERY GP User manual

USE AND MAINTENANCE MANUAL
Rx Only - CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed dentist.
0051

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NOT SUPPLIED

Piezosurgery GP is manufactured and sold internationally by Mectron S.p.A.
under the name Piezosurgery white
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Copyright
© Mectron S.p.A. 2021. All rights reserved. No part of this document can be reproduced in any
form without the written consent of the copyright owner.

II
TABLE OF CONTENTS
1 Introduction 1
1.1 Intended Use of PIEZOSURGERY® GP 1
1.2 Description of the Device 2
1.2.1 Users 2
1.3 Disclaimer 2
1.4 Safety Precautions 3
1.5 Symbols 5
2 IdenticationData 7
2.1 DeviceIdenticationLabel 7
2.2 HandpieceIdenticationData 7
2.3 InsertsIdenticationData 8
3 Delivery 9
3.1 List of the Components of PIEZOSURGERY® GP 9
4 Installation 10
4.1 Safety Requirements in the Installation Phase 10
4.2 Connecting the Accessories 11
5 Use 14
5.1 SwitchingtheDeviceOnandO 14
5.2 Description of the Keyboard 14
5.3 Instructions for Use 20
5.4 Important Information on Inserts 23
6 Maintenance 24
7 DisposalMethodandPrecautions 24
8 TechnicalSpecications 25
8.1 ElectromagneticCompatibilityIEC/EN60601-1-2 26
8.1.1 GuidanceandManufacturer’sDeclaration-ElectromagneticEmissions 26
8.1.2 AccessiblePartsoftheCasing 27
8.1.3 GuidanceandManufacturer’sDeclaration-ElectromagneticImmunity 28
8.1.3.1 PowerConnectionA.C.Input 28
8.1.3.2 PointsofContactwiththePatient 30
8.1.3.3 PartsAccessibletotheInput/OutputSignals 31
8.1.4 SpecicationsofthetestsfortheImmunityoftheAccessiblePartsofthe
Casing to the Wireless RF Communications Device 32
9 Troubleshooting 33
9.1 Diagnostic System and Symbols on Keyboard 33
9.2 Troubleshooting Quick Guide 35
9.3 FusesReplacement 37
9.4 CustomerService-Returnsand/orRepairs 38
9.4.1 Repairs 38
9.4.2 ReturnedGoods 38
10 Warranty 39

III
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IV
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1
INTRODUCTION
1 INTRODUCTION
1 http://mectron.it/en/technical-support/users-manuals/
Carefully read this manual before proceeding
with installation operations, use, maintenance
or other intervention operations on the device.
Always keep this manual at hand.
IMPORTANT: To avoid potential serious
injurytotheuserandthepatientand/or
this device or other equipment, 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as:
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 ensure
that operators are aware of the safety
requirements, installation procedures, and
instructions for correct use and maintenance
of the device and its accessories. Using this
manual for purposes other than those relating
to the installation, use and maintenance of the
device, is strictly prohibited. The information
and illustrations contained in this manual are
updatedasofthedateofpublicationspecied
on the last page.
The manufacturer MECTRON S.p.A. is
committed to the continuous updating of
its products, which may entail changes to
components of the device.
In case you encounter discrepancies between
the descriptions found in this manual and the
equipment in your possession you can:
• check for any available updates in
the section MANUALS of MECTRON
website
1
;
• contact Piezosurgery Inc. Customer
Service.
1.1 IntendedUseofPIEZOSURGERY®GP
PIEZOSURGERY® GP is a piezoelectric
ultrasonic device, consisting of handpiece/s
and associated inserts intended for:
• Bone cutting, osteotomy, osteoplasty
and drilling in a variety of oral surgical
procedures, including implantology,
periodontal surgery, surgical
orthodontics and surgical endodontics
procedures;
• Scaling applications including:
• Scaling: All general procedures
for removal of supragingival 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,gutta-perchacondensation
and retrograde preparation;
• Restorative and Prosthetics: Cavity
preparation, removal of prostheses,
amalgamcondensation,nishingof
crownpreparationsandinlay/onlay
condensation.
WARNING: Riskofexplosion.
The device cannot function in places where
there is an atmosphere saturated with
ammablegases(anaestheticmixtures,
oxygen,etc.).

2
WARNING: Qualiedandspecialized
personnel.The device must be used
exclusivelybyspecializedandappropriately
trained personnel such as a licensed dentist
completely familiar with the required
techniques and instructions for use of the
equipment. The use of the device does not
causesideeectsifitisusedcorrectly.An
improper use might cause tissues heating.
WARNING: Use the device only for the
intended use.
Failure to observe this precaution may cause
serious injuries to the patient, the operator,
anddamages/breakdownstothedevice.
1.2 DescriptionoftheDevice
The PIEZOSURGERY® GP is a device that
uses ultrasonic piezoelectric technology to
generate mechanical microvibrations of the
inserts, to eectively cut mineralized tissues.
Thisallowsanecientandsafecuttingwhich
preserves the integrity of the osteotomized
surfaces.
The micrometric, ultrasonic vibrations of
the inserts provide greater precision and
a selective cutting action compared to
traditional methods such as drills or oscillating
saws (which act with macrovibrations),
thereforeminimizingtraumaticeectonsoft
tissues.
Thecavitationeectoftheirrigatingsolution
helpstokeeptheoperatoryeldblood-free.
This provides an optimal intra-operatory
visual control thus increasing safety, even in
areas that are anatomically most dicult to
access.
1.2.1 Users
U.S. Federal law restricts this device to sale by or on the order of a licensed dentist.
1.3 Disclaimer
ThemanufacturerMectronandthedistributor,PiezosurgeryInc.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 improper practice in the use of the device and
its accessories. The manufacturer Mectron and the distributor, Piezosurgery Inc. shall be under
noliability,expressedorimplied,withrespecttoanydamages(personalinjuryand/ordamage
toproperty)whichmightariseorbecaused,whetherbythecustomerorbyanyoftheusersof
the product and its accessories, as result of:
1. Useorproceduresdierentthanthose
speciedintheintendeduseofthe
product;
2. The environmental conditions for the
preservation and storage of the device
are not compliant to the precautions
indicated in the Chapter8onpage
25;
3. The device is not used in compliance
with all the instructions and precautions
described in this manual;
4. The electrical system in the premises
in which the device is used is not
compliant to the norms in force and to
the relative precautions;
5. Theassemblyoperations,extensions,
adjustments, updates, and repairs on
the device are performed by personnel
not authorized by Piezosurgery Inc.;
 6. Improperuse,mistreatments,and/or
incorrect interventions;
 7. Any and all attempts to tamper with
or modify the device, under any
circumstance;
 8. Useofnon-originalPiezosurgery/
Mectroninsertsthatentailanite
damage to the threading of the
handpiece, thus compromising correct

3
INTRODUCTION
operation and causing risk of harm to
the patient:
9. Useofnon-originalPiezosurgery/
Mectron inserts, used in accordance
to designed and tested settings
ofPiezosurgery/Mectronoriginal
inserts. The correct use of the settings
is guaranteed only with original
Piezosurgery/Mectroninserts;
10. Lack of stock materials (handpiece,
inserts,wrenches)tobeusedinthe
event of device stop due to fault or of
inconveniences.
1.4 SafetyPrecautions
WARNING: Riskofexplosion.
The device cannot operate in environments
where the atmosphere is saturated with
ammablegases(anaestheticmixtures,
oxygen,etc.).
CAUTION: In the case that the end user,
when operating in his or her own medical
studyorclinic,mustsubjecttheelectro-
medical equipment and systems to periodical
inspections in order to adhere to imposed
requirements, the test procedures that must
beappliedtoelectro-medicalequipment
and systems to evaluate safety must be
performedinlinewithnormEN62353
‘Medicalelectricalequipment-Recurrent
test and test after repair of medical electrical
equipment’.Theintervalforperiodicchecks,
in the intended operating conditions and
described in this “Use and Maintenance”
manual, is one year.
WARNING: Checkingdevicestatus
beforethetreatment.
Always check that there is no water
underneath the device. Before every
treatment, always check that the device
works perfectly and that the accessories
areecient.Incaseyouuncoveroperating
abnormalities, do not perform the treatment.
Contact Piezosurgery Inc. Customer Service if
the abnormalities concern the device.
CAUTION: The electrical system of the
premises in which the device is installed
and used must be compliant to the norms
in force and to the relative electrical safety
precautions.
CAUTION: Only connect the console to
hospital grade receptacles to ensure electrical
grounding reliability. This device must be
grounded.
WARNING: Do not operate the
footswitch of the PIEZOSURGERY® GP
device when the pump head of the peristaltic
pump is open. Moving parts could injure the
operator.
WARNING: Controlofinfections.
First Use The reusable accessories (brand
neworreturnedbyservice)andthesingle-
useaccessories(diamondcoatedinserts)are
deliveredinNON-STERILEconditionsand
must be prepared prior to use by applying
the procedures described in the Cleaning and
Sterilization manual provided with the device.
EveryuseOnce used, each reusable
accessory must be thoroughly reprocessed
prior to reuse, according to the procedures
described in the Cleaning and Sterilization
manual provided with the device.

4
WARNING: Breakageandwear-outof
the inserts. High frequency oscillations and
wear-outmay,inrarecircumstances,leadto
the breakage of the insert.
Deformed or otherwise damaged inserts are
susceptible to breakage during their use.
These inserts must never be used.
If an insert breaks, check that none of its
fragments remain in the treated part and,
atthesametime,apply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
inserts.
When the nitride coating wears out, the
cuttingeciencydecreases;re-sharpening
the insert damages it and is therefore
forbidden. Check that the insert is not worn
out.Useofaworn-outinsertreducesthe
cutting performance and can cause necrosis
of the bone surface treated.
During the intervention, frequently check that
the insert is intact, especially in its apical part.
During the intervention, avoid prolonged
contact with retractors or with metallic
instrumentationinuse.Donotexertexcessive
pressure on the inserts during their use.
WARNING: Diamond coated inserts are
intended for single use only.
WARNING: Only use original
Piezosurgery/Mectroninserts,accessories,
and spare parts.
WARNING: Contraindications. Do not
use the PIEZOSURGERY® GP on patients
whocarryheartstimulators(Pace-makers)
or other implantable electronic devices. This
precaution also applies to the operator.
WARNING: Contraindications.
Interferencefromotherequipment. An
electricalscalpelorotherelectro-surgical
units near the PIEZOSURGERY® GP device
may interfere with its correct operation.
CAUTION: Contraindications. Do not
performtreatmentsonmetalorceramic/
porcelain prosthetic artifacts (unless
otherwisespecied).Theultrasonicvibration
couldcausedecementation/looseningof
such artifacts.
WARNING: Contraindications.
Interferencewithotherequipment.
Although PIEZOSURGERY® GP complies
withstandardIEC60601-1-2,itmayinterfere
with other equipment located nearby.
PIEZOSURGERY® GP must not be used near,
or stacked on other devices.
If adjacent or stacked use is necessary, the
Piezosurgery® touch and the other devices
must be observed and checked to verify
normaloperationinthecongurationin
which they will be used.
CAUTION: Contraindications.Allow
reusable, autoclavable items to gradually
return to room temperature after steam
sterilization and prior to usage. The cooling
process must not be accelerated.
CAUTION:Nomodicationofthis
equipment is allowed.

5
INTRODUCTION
1.5 Symbols
Symbol Description Symbol Description
0051
Device compliant
with Regulation (EU)
2017/745. Notied
body: IMQ S.p.A.
Nemko Mark
UL CSA compliance
Medical Device Caution, read the
Instructions For Use
Operating Instructions Manufacturer
Date of manufacture Serial Number
Lot Number Product Number
Single-Use Donotre-sterilize
Use-bydate Sterilized with Ethylene
Oxide(EO)
Non-sterile
Can be sterilized in
autoclave up to a
maximumtemperature
of 135° C
Type “B” applied part
asperEN60601-1
recommendation
Equi-potentiality
Alternating Current Connection of the foot
pedal
I Activation switch “on” 0 Activationswitch“o”
Functional earth Caution, risk of electric
shock
Biohazard
The device and its
accessories must not be
disposed of or treated
as solid urban wastes

6
Symbol Description Symbol Description
General warning a) Do not touch moving
parts b)
Temperature limitation
for transport and
storage
Humidity limitation for
transport and storage
Atmospheric pressure
limitation for transport
and storage
Do not use if package is
damaged
IP22
International Protection
Code of the mechanical
casing.
IP20
International Protection
Code of the mechanical
casing.
QTY.1 Quantity of items in the
package: 1 RxOnly
For US market, only.
CAUTION:
U.S. Federal
law restricts this device
to sale by or on the
order of a licensed
dentist
Table1 – Symbols
 a) The symbol is represented by a yellow warning
triangle and a black graphical symbol.
 b) Thesymbolisrepresentedbyaredcircle-with-slash
and a black graphical symbol.

7
IDENTIFICATION DATA
2 IDENTIFICATIONDATA
A precise description of the model and device
serial number will facilitate the After-Sales
Service to answer the inquiries quickly and
eectively.
Always provide this information when
contacting Piezosurgery Inc. Customer Service.
2.1 DeviceIdenticationLabel
NOTE: PIEZOSURGERY® GP is manufactured
and sold internationally by Mectron S.p.A.
under the name PIEZOSURGERY® white.
Every device has an identication
label that reports the main technical
characteristics and the serial number.
The identication label is located under
the device. The complete technical
specications are reported in Chapter 8
on page 25 .
manufacturer
Mectron S.p.A.
Via Loreto 15/A
16042 Carasco -GE- Italy
415000000
PIEZOSURGERY white
100-240 V~120 VA - 50/60 Hz.
Rx Only
0051
00000000 YYYY-MM-DD
made in Italy
HIBC 128 Bar Code
A separate label shows further symbols
and characteristics of the device. This
identication label is placed under the
device.
NOTE: The complete list of symbols and
their description are shown in Chapter
1.5 on page 5.
PIEZOSURGERY white
Device for intermittent operation:
60 s ON - 30 s OFF with irrigation
30 s ON - 120 s OFF without irrigation (ENDO,
PERIO)
2.2 HandpieceIdenticationData
Eachhandpieceislaser-markedwith(referto
Figure 1 at page 8):
• itsserialnumber(SN);
• itsproductnumber(REF);
• its date of manufacturing;
• the device name (PIEZOSURGERY®
white);
• the Mectron logo;
• HIBC128DataMatrix;
• CE, MD, Applied Part and Sterilizable
symbols.
NOTE: The complete list of symbols and their
description are shown in Chapter 1.5 on page
5.
NOTE: PIEZOSURGERY® GP is manufactured
and sold internationally by Mectron S.p.A.
under the name PIEZOSURGERY® white.

8
PIEZOSURGERY®
white
HIBC 128
Data Matrix
402000000
03120217
0051
YYYY-MM
white
Figure1 – HandpieceIdenticationData
2.3 InsertsIdenticationData
The following data are laser-marked on
each insert:
• thenameoftheinsert(Ref.1);
• theMectronlogo(Ref.2);
• and the lot number to which the
insertbelongs(Ref.3);
OT7
A A/XXXXX
1 2 3

9
DELIVERY
3 DELIVERY
3.1 ListoftheComponentsofPIEZOSURGERY®GP
Refer to the front endpaper.
PIEZOSURGERY® GP consists of:
A. Device core system;
B. Peristaltic pump;
C. Irrigation bag support rod;
D. PIEZOSURGERY®GPhandpiecexed
holder;
E. Use and Maintenance Manual, Cleaning
and Sterilization Manual;
F. Power Cord;
G. Foot pedal with cable and connector;
H. Back-upfootpedal;
I. K8Mectrontorquewrench;
J. Peristaltic pump tubing kit (The kit is
composedbyasetof6peristalticpump
tubing);
K. Case.
The following components/accessories are
sold separately from the PIEZOSURGERY® GP
device:
CAUTION: The handpiece and the cord
cannot be separated.
NOTE:Thestainless-steelboxsuppliedwith
the Piezosurgery handpiece is intended
exclusivelyfortransportation,fromthe
working area to the decontamination area
and NOT for the sterilization process.
L. PIEZOSURGERY® handpiece complete
withcord(withorwithoutLEDlight);
M. PIEZOSURGERY® GP handpiece
movable holder;
N. Bone grafting kit;
O. Inserts/insertkit.
NOTE:Someinsertsrequirespecic
accessories and tools for being correctly
used(forexamplekitsand/ordedicated
torquewrenches).Alwaysreadandfollowthe
assembly and cleaning instructions supplied
with the insert.
PIEZOSURGERY® GP consists of accessories
that can be ordered separately. Refer to the
“Packing List” included in your package, so
that you may exactly know the quantity and
type of the accessories supplied with the
device you have purchased.
The packaging of the device cannot undergo
strong impacts as contains electronic
components, therefore the transport and the
storage must be carried out with particular care.
Do not stack more boxes in order to avoid
damaging the underlying packaging.
All material shipped by Piezosurgery Inc. is
controlled at the time of dispatch.
The device is shipped appropriately protected
and packaged.
Upon receipt of the device, check for any
possible damage caused during transport and
incaseany damageand/ordefects isfound,
complain to the transporter.
Keep the packaging in case there is a necessity
to send any item to Piezosurgery Inc. Customer
Service and to store the device during long
periods of inactivity.
WARNING: Before starting to operate
with the device, make sure that you have
stockmaterial(handpiece,inserts,wrenches)
available to use in case the device stops due
to a fault or of inconveniences.

10
4 INSTALLATION
The device must be installed in a suitable and
convenient place for its use.
Place the console on a sturdy, at ,dry and
horizontal surface.
Position the device in way so that the power
plug is always, easily reachable, since this plug
is considered as a disconnecting means.
Take care to ensure that cables do not hinder
the free movement of personnel.
4.1 SafetyRequirementsintheInstallationPhase
WARNING: Contraindications.
Interferencewithotherequipment.
Although PIEZOSURGERY® GP complies
withstandardIEC60601-1-2,itmayinterfere
with other equipment located nearby.
PIEZOSURGERY® GP must not be used near,
or stacked on other devices.
If adjacent or stacked use is necessary, the
Piezosurgery® touch and the other devices
must be observed and checked to verify
normaloperationinthecongurationin
which they will be used.
WARNING: Contraindications.
Interferencefromotherequipment. An
electricalscalpelorotherelectro-surgical
units near the PIEZOSURGERY® GP device
may interfere with its correct operation.
CAUTION: The electrical system of the
premises in which the device is installed
and used must be compliant to the norms
in force and to the relative electrical safety
precautions.
CAUTION: Only connect the console to
hospital grade receptacles to ensure electrical
grounding reliability. This device must be
grounded.
WARNING: Donotinstallthedevicein
placeswherethereisariskofexplosion.
The device cannot operate in environments
whereanestheticorammablemixturesare
present.
WARNING: Do not operate the
footswitch of the PIEZOSURGERY® GP device
when the peristaltic pump cover is open.
Moving parts could injure the operator.
WARNING: Install the device in a place
protected against collisions or against
accidental sprays of water or liquids.
WARNING: Do not install the device
above or near heat sources. Foresee
adequate air circulation around the device
when installing it. Leave adequate space,
especially near the fan placed on the back
part of the device.
CAUTION:Donotexposethedeviceto
direct sunlight or to sources of UV light.
CAUTION: The device can be transported,
but it must be handled with care when it is
displaced. Position the foot pedal on ground,
so that it can only be activated intentionally
by the operator.
CAUTION: Before connecting the
handpiece cord to the device, make sure that
the electrical contacts are perfectly dry. If
need be, dry them with compressed air.
CAUTION:Nomodicationofthis
equipment is allowed.

11
INSTALLATION
4.2 Connecting the Accessories
Insert the irrigation bag support rod in
the dedicated hole;
1
Insert the handpiece xed holder in its
housing.
The handpiece xed holder must be
used only to hold the Piezosurgery®
handpiece.
NOTE:Thehandpiecexedholdercan
beplacedin4dierentpositions:right
side, front right side, front left side and
left side;
2
Insert the peristaltic pump tubing,
supplied with the device, into the
connector of the handpiece cord;
CAUTION:UseoriginalPiezosurgery/
Mectron peristaltic pump tubing only,
as damage or substandard performance
could result.
3
With the writing UP facing upward, insert
the connector of the handpiece cord
into the handpiece receptacle on the
PIEZOSURGERY® GP console;
4

12
Fit the peristaltic pump tubing into the
peristaltic pump proceeding as follows:
• Open completely the peristaltic
pump cover;
5
• Insert the tubing by placing it over
the pump rollers;
• Close the peristaltic pump cover
completely;
WARNING: Do not operate the
footswitch of the PIEZOSURGERY® GP
device when the peristaltic pump cover
is open. Moving parts could injure the
operator.
6
Connect the peristaltic pump tubing to
theowadjuster(notsupplied);
7
Connecttheowadjuster(notsupplied)
to the liquid bag used for the treatment
(bag not supplied). Hang the bag to its
specicsupportrod;
NOTE: The irrigation bag holder stand
must be used with bags of up to a
maximumof1000mlcapacity.
8