mectron Piezosurgery flex User manual

USE AND MAINTENANCE MANUAL
GEBRAUCHS- UND WARTUNGSANLEITUNG
MANUALE D’USO E MANUTENZIONE
MODE D’EMPLOI ET D’ENTRETIEN
MANUAL DE USO Y MANTENIMIENTO
flex
0051

A
B
CH
K
E
J
ID
F
G
L M
P
O
N

USE AND MAINTENANCE MANUAL
flex

flex

I
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
flex
SUMMARY
1 Introduction 1
1.1 Intended Use 1
1.2 Description of the Device 2
1.2.1 Patient Group Directions 2
1.2.2 Patient Selection Criteria 2
1.2.3 Indications for Use 2
1.2.4 Users 3
1.3 Disclaimer 3
1.4 Safety Precautions 4
1.5 Symbols 6
2 IdenticationData 8
2.1 DeviceIdenticationLabel 8
2.2 HandpieceIdenticationData 8
2.3 InsertsIdenticationData 9
3 Delivery 10
3.1 ListoftheComponentsofthePIEZOSURGERY®ex 10
4 Installation 11
4.1 Safety Requirements in the Installation Phase 11
4.2 Connecting the Accessories 12
5 Use 16
5.1 SwitchingtheDeviceOnandO 16
5.2 Description of the Keyboard 17
5.3 FootPedalButton 18
5.4 SafetyRequirementsBeforeandDuringUse 19
5.5 Instructions for Use 22
5.6 Important Information on Inserts 24
6 Maintenance 25
7 DisposalMethodandPrecautions 25
8 TechnicalSpecications 26
8.1 ElectromagneticCompatibilityIEC/EN60601-1-2 27
8.1.1 GuidanceandManufacturer’sDeclaration-ElectromagneticEmissions 27
8.1.2 AccessiblePartsoftheCasing 28
8.1.3 GuidanceandManufacturer’sDeclaration-ElectromagneticImmunity 29
8.1.3.1 PowerConnectionA.C.Input 29
8.1.3.2 PointsofContactwiththePatient 31
8.1.3.3 PartsAccessibletotheInput/OutputSignals 32
8.1.4 SpecicationsofthetestsfortheImmunityoftheAccessiblePartsofthe
Casing to the Wireless RF Communications Device 33
9 Troubleshooting 34
9.1 DiagnosticSystemandSymbolsonKeyboard 34
9.2 TroubleshootingQuickGuide 36
9.3 FusesReplacement 38
9.4 SendingtoanAuthorizedMectronServiceCentre 39
10 Warranty 40

III
PAGEINTENTIONALLYLEFTBLANK

IV
flex
PAGEINTENTIONALLYLEFTBLANK

1
INTRODUCTION
1 INTRODUCTION
1 manuals.mectron.com
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 damages to persons or
things, read with particular attention all the
chapters “Safety Requirements” present in the
manual.
According to the degree of severity the safety
requirementsareclassiedwiththefollowing
indications:
WARNING: (Always referred to damage
to persons)
CAUTION: (Referring to possible
damages to things)
Theaimofthismanualistomaketheoperators
aware of the safety regulations, installation
procedures, instructions for proper use and
maintenance of the device and its accessories.
Use of this manual for aims other than those
strictly linked to the installation, use and
maintenance of the device is prohibited.
The information and illustrations in this
manual were updated on the edition date
shown on the last page.
MECTRON is engaged in continuously
updating its products with possible changes
to the components of the apparatus.
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
;
• askclaricationstoYourDealer;
• contact MECTRON After Sales Service.
1.1 Intended Use
PIEZOSURGERY®ex is a piezoelectric
surgical system intended for use in bone
cutting, equipped with special insert tips to
perform osteotomy, osteoplasty and drilling
in a variety of surgical procedures:
• Otolaryngology;
• Oral/MaxillofacialSurgery;
• Hand and foot Surgery;
• Plastic/ReconstructiveSurgery.
It may also be used with endoscopic assistance
to perform the above listed procedures.
WARNING: Use the device only for
the intended use. Failure to meet these
requirements may cause serious injuries to
thepatient,theoperator,anddamages/
breakdownsofthedevice.
WARNING: Carefully read this manual
and follow its recommendations in order
toavoidtocompromisethepatientand/
or the user safety. Failure to meet these
requirements may cause serious injuries to
thepatientand/ortheoperator.
WARNING: Qualiedandspecialized
personnel.The device must be used
exclusivelybyspecializedpersonnelsuchas
Surgeon. To use the device no special training
is requested. The use of the device does not
causesideeectsifitisusedcorrectly.An
improper use might cause tissues heating.
WARNING: The device must be used in
a hospital environment, such as an operating
theatre.
WARNING: Riskofexplosion.
The device cannot function in places where
there is an atmosphere saturated with
ammablegases(anaestheticmixtures,
oxygen,etc.).

2
flex
1.2 DescriptionoftheDevice
Theuserinterfacehasbeenoptimizedwiththe
PIEZOSURGERY®exmakingallthefunctions
readily available by integrating them in the
touchkeyboard.
The PIEZOSURGERY®ex 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.
This medical device can be used on any
patient of any age, weight, height, gender and
nationality.
1.2.1 PatientGroupDirections
This medical device is designed to be used with the following patient population:
• Infants;
• Children;
• Adolescents;
• Adults;
• Elderly.
This medical device can be used on any
patient of any age, weight, height, gender and
nationality.
1.2.2 PatientSelectionCriteria
The use of the device is not recommended in
the following cases:
1. Patients with active implantable
medicaldevices(forexample:
pacemakers,hearingaidsand/orother
electromagnetic prostheses) without
thepriorauthorizationoftheirdoctor;
2. Women who are pregnant or
breastfeeding, due to the restrictions
associated with the possible use of
medical solutions such as anaesthetics
3. Patients with allergies;
4. Patients with pathologies or clinical
conditions for which it is not
recommended to perform surgery
or for which it may represent a
contraindication according to the
treating physician. These conditions
may include, but are not limited to:
heart disease, diabetes, cirrhosis, HIV
infection, pregnancy or breastfeeding,
radiation therapy, chemotherapy,
immuno-suppressivetherapy,allergies
and psychiatric disorders;
5. Patients with unsuitable treatment sites.
All models of “Piezosurgery” bone surgery
devices are intended for professional use only.
Therefore, the user is the only person able to
decide if and how to treat their patients.
1.2.3 IndicationsforUse
The use of the device is suitable for all the appropriate patients (see chapter above) for whom a
bone surgery treatment is prescribed, by the treating physician, within the intended use of the
device (see Chapter 1.1 on page 1 ).

3
INTRODUCTION
1.2.4 Users
The device must be used only by specialised and properly trained personnel, such as a surgeon
physician,able-bodiedadultsofanyweight,age,height,genderandnationality.
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 improper practice in the use of the device and its accessories.
ThemanufacturerMectronshallbeundernoliability,expressedorimplied,withrespecttoany
damages(personalinjuryand/ordamagetoproperty)whichmightariseorbecaused,whether
by the customer or by any of the users of the product and its accessories, as result of:
1. 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 with the precautions
indicated in the Chapter8onpage
26;
3. The device is not used in compliance
with all the instructions and precautions
described in this manual;
4. The electrical system of the relevant
operating room is not compliant with
the applicable regulations and with
electrical safety requirements;
5. Theassemblyoperations,extensions,
adjustments, updates, and repairs on
the device are performed by personnel
notauthorizedbyMectron;
6. Improperuse,mistreatments,and/or
incorrect interventions;
7. Any and all attempts to tamper with
or modify the device, under any
circumstance;
 8. Useofnon-originalMectroninserts
that damage the threading of the
handpiece, thus compromising correct
operationandcausingriskofharmto
the patient;
 9. Useofnon-originalMectroninserts,
even if they are used in accordance
to designed and tested settings of
Mectron original inserts. The correct use
of the settings is guaranteed only with
original Mectron inserts;
10. Lackofstockmaterials(handpiece,
inserts, wrenches) to be used in the
event of device stop due to fault or of
inconveniences.

4
flex
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.).
WARNING: Contraindications.
Interference with other equipment. The
PIEZOSURGERY®exdevicecomplieswith
thestandardIEC60601-1-2.However,itmay
interfere with other devices in its vicinity.
InstallPIEZOSURGERY®exatsafetydistance
fromlife-supportsystems.Ifadjacentor
stackeduseofthedeviceisnecessary,
normal operation of the equipment and
PIEZOSURGERY®ex,intheconguration
inwhichtheywillbeused,shouldbeveried
prior their use.
WARNING: Contraindications.
Interferencebyotherequipment. An
electrosurgicalknifeofotherelectrosurgical
units placed in the vicinity of the
PIEZOSURGERY®exdevicemayinterfere
with its correct functioning.
CAUTION: In the case the hospital must
subjecttheelectro-medicalequipment
and systems to periodical inspections in
order to adhere to imposed requirements
in its own structure, the test procedures
thatmustbeappliedtoelectro-medical
equipment and systems to evaluate safety
must be performed in line with norm EN
62353‘Electro-medicaldevices-Periodical
inspections and tests to be performed after
repairinterventionsonelectro-medical
devices’.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.Ifanythingunusual
is noted during operation, do not perform
the treatment. If the problem concerns the
device,contactanAuthorizedMectron
Service Center.
CAUTION: The electrical system of the
relevant operating room, where the device
is installed and used, must comply with the
applicable regulations and with electrical
safety requirements.
CAUTION:Toavoidriskofelectricshock,
this device must be grounded.
WARNING: Do not operate the foot
pedalofthePIEZOSURGERY®exwhenthe
peristaltic pump cover is open. Moving parts
could injure the operator.
WARNING: Personalinjury.Takecare
to ensure that cables do not hinder the free
movement of personnel.
CAUTION: US Federal Law (of the United
States of America) restricts this device to sale
by or on the order of a physician.
WARNING: Prior to any use, system
components should be inspected for
damage. Do not use if damage is apparent.
WARNING: Do not activate the device if
thehandpieceisfaulty,damagedorbroken.
Replace the handpiece immediately.
WARNING: Only use original Mectron
accessories and spare parts.
CAUTION:Nomodicationofthis
equipment is allowed.
WARNING: Contraindications. Do
notusePIEZOSURGERY®exonpatients
withheartstimulators(Pace-makers)or
other implantable electronic devices. This
precaution also applies to the operator.

5
INTRODUCTION
CAUTION: Contraindications. 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:Infectioncontrol.
Toensuremaximumsafetyofthepatientand
the operator, verify the reusable parts and
accessorieshasbeencleanedandsterilized
prior to use, following the instructions of the
CleaningandSterilizationManual.
WARNING: Cleaningandsterilisation
ofneworrepairedtools. All new and
repaired reusable device accessories are
suppliednon-sterile.Beforerstuse,and
after each treatment, they must be cleaned
and sterilised in strict compliance with
the instructions given in the Cleaning and
Sterilisation Manual.
CAUTION: Contraindications. When the
reusable items (the handpiece, the torque
wrench, and any other accessory that can be
sterilized)havebeenautoclavesterilized,
wait for them to cool down to room
temperature prior to usage. The cooling
process must not be accelerated.
WARNING: Breakageandwear-outof
the inserts. In rare cases, high frequency
oscillationsandwear-outmayleadto
breakageofaninsert.Deformedorotherwise
damagedinsertsaresusceptibletobreakage
during their use. These inserts must never
be used. Should an insert fracture during
use,extremecaremustbeexercisedto
ensure that all the fragments of the insert
are retrieved and removed from the surgical
siteand,atthesametime,thataneective
suction is applied. During surgery, frequently
checkthattheinsertisintact,especiallyinits
apical part. During surgery, avoid prolonged
contact with retractors or other metal objects
being used. During surgery, do not apply
excessivepressureontheinserts.
WARNING:Ifanadverseeventand/or
serious accident attributable to the device
occurs during correct and intended use, it is
recommended to report it to the Competent
Authority and to the manufacturer indicated
on the product label.

6
flex
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resterilize
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

7
INTRODUCTION
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
IPX8
International Protection
Code of the mechanical
casing. Liquid ingress
protection.
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
physician
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.

8
flex
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 an Authorised Mectron Service Centre.
2.1 DeviceIdenticationLabel
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 26 .
manufacturer
Mectron S.p.A.
Via Loreto 15/A
16042 Carasco -GE- Italy
413000000
PIEZOSURGERY flex
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 6 .Device for intermittent operation:
60 s ON - 30 s OFF with irrigation
PIEZOSURGERY flex
2.2 HandpieceIdenticationData
Eachhandpieceislaser-markedwith(referto Figure 1 at page 9 ):
• its serial number (SN);
• its product number (REF);
• its date of manufacturing;
• the device name (PIEZOSURGERY®
medical);
• 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
6.

9
IDENTIFICATION DATA
PIEZOSURGERY®
medical
HIBC 128
Data Matrix
medical
408000000
03120127
0051
YYYY-MM
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);
• the lot number to which the insert
belongs (Ref. 3);
• thesymbols“Single-use”and
“CAUTION: read the instructions for
use” (Ref. 4)
MT1-10
A A/XXXXX
1 2 3 4

10
flex
3 DELIVERY
3.1 ListoftheComponentsofthePIEZOSURGERY®ex
Refer to the front endpaper.
PIEZOSURGERY®exconsistsof:
A. Device core system;
B. Peristaltic pump;
C. Stand for Solution Bag;
D. Use and Maintenance Manual, Cleaning
andSterilizationManual;
E. Power Cord;
F. FootPedalwithbracket,cableand
connector;
G. Case.
Available accessories:
H. PIEZOSURGERY® medical handpiece
complete with cord and the connector
protective cap (produced by Mectron);
CAUTION: The handpiece and the cord
cannot be separated.
I. PIEZOSURGERY®medicalsingle-use
inserts (produced by Mectron);
J. PIEZOSURGERY® medical single use
irrigationkit(distributedbyMectron);
K. PIEZOSURGERY® medical torque
wrench (produced by Mectron).
PIEZOSURGERY®ex consists of accessories
that can be ordered separately.
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. All material shipped by Mectron 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aMECTRONAuthorized
Service Centre 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.

11
INSTALLATION
4 INSTALLATION
To guarantee proper device functionality, it
must be installed by an authorised Mectron
technician. The device must be installed in a
suitable and convenient place for its use.
The technician will need to carry out the
following 6 steps:
1. Unpackthedevice;
2. Explaintotheuserwhatprecautions
needtobetakentoensurecorrect
installation;
3. Explaintotheuserallthepossible
devicecongurations;
4. Explainhowtoclean,steriliseand
maintain the system;
5. Fill in the installation and hospital
personnel training forms;
6. Send Mectron the completed forms to
guarantee traceability of the device and
the activation of the warranty.
4.1 SafetyRequirementsintheInstallationPhase
WARNING: Contraindications.
Interference with other equipment. The
PIEZOSURGERY®exdevicecomplieswith
thestandardIEC60601-1-2.However,itmay
interfere with other devices in its vicinity.
InstallPIEZOSURGERY®exatsafetydistance
fromlife-supportsystems.Ifadjacentor
stackeduseofthedeviceisnecessary,
normal operation of the equipment and
PIEZOSURGERY®ex,intheconguration
inwhichtheywillbeused,shouldbeveried
prior their use.
WARNING: Contraindications.
Interferencebyotherequipment. An
electrosurgicalknifeofotherelectrosurgical
units placed in the vicinity of the
PIEZOSURGERY®exdevicemayinterfere
with its correct functioning.
WARNING: Riskofexplosion.The
device cannot operate in environments where
theatmosphereissaturatedwithammable
gases(anestheticmixtures,oxigen,etc.).
CAUTION: The electrical system of the
relevant operating room, where the device
is installed and used, must comply with the
applicable regulations and with electrical
safety requirements.
CAUTION:Toavoidriskofelectricshock,
this device must be grounded.
WARNING: Do not operate the foot
pedal of the PIEZOSURGERY®ex when the
peristaltic pump lid is open. Moving parts
could injure the operator.
WARNING: Install the device in a place
protected against impacts or accidental
splashes of water or other liquids.
WARNING: Do not install the device
on top of or close to sources of heat. When
installing,makesurethatadequateair
circulatesaroundthedevice.Leavesucient
room around it, with particular reference to
the fan on the rear.
CAUTION:Donotexposethedeviceto
direct sunlight or sources of UV light.
CAUTION: The device is transportable
but must be handled with care when moved.
Positionthefootswitchontheoorinsucha
way 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
necessary, dry them with compressed air.
CAUTION: Do not allow the device
console and the foot pedal to get wet. If
liquid enters the console or footswitch,
damage could occur.
CAUTION:Nomodicationofthis
equipment is allowed.

12
flex
CAUTION: Position the device in way
so that the power plug is always, easily
reachable, since this plug is considered as a
disconnecting means.
WARNING: Before using the
PIEZOSURGERY®Medicalirrigationkit,check
theintegrityofthesterilepackagingand
inspecttheproducttoexcludethepresence
ofanydamage.Donotusetheirrigationkit
ifthepackagingisopenordamaged.The
irrigationsetlosessterilityifthepackaging
isbrokenordamaged.Ifthepackagingis
damaged or unintentionally opened before
the use, proceed with the disposal of the set.
Theproductcannotbere-sterilizedorreused.
4.2 Connecting the Accessories
Equipotential plug: The device is equipped
with an additional equipotential plug
located on the rear of the console.
This plug is in accordance with DIN
42801.
Insert the connector of the equipotential
cord (optional) to the plug on the rear of
thedevice’sconsole.
The purpose of additional potential
equalization is to reduce dierences
of potential which can occur during
operationbetweenthedevice’sbodyand
conductive parts of other objects within
the medical environment;
1
Plug the power supply cord into the
powersocketonthebackofthedevice
and then into the mains power outlet;
2