mectron Piezosurgery User manual

Manuale d’uso e manutenzione
Manual of use and maintenance
Gebrauchs- und Wartungshandbuch
Notice d’utilisation et d’entretien
Manual de uso y mantenimiento
IT
EN
DE
FR
ES

52  Manualofuseandmaintenance
Table of contents
 1 INTRODUCTION 54
 1.1 Preface 54
 1.2 Typetesting 54
 1.3 Descriptionofthedevice 54
 1.4 IntendedUse 55
 1.5 IntendedUse 55
 1.5.1 Importantsafetyrecommendations 55
 1.6 Symbolsused 57
2 IDENTIFICATION DATA 59
 2.1 PiezosurgeryMedicaldeviceidentication 59
 2.2 PiezosurgeryMedicalhandpieceidentication 59
3 DELIVERY 60
 3.1 Deliveryofthedevice 60
 3.2 Standardlistofmaterialssupplied 60
 3.3 Accessories 60
4 INSTALLATION 62
 4.1 Safetymeasurestoapplyintheinstallationphase 62
 4.2 Firstinstallation 63
5 ASSEMBLY, CONFIGURATION AND USE 65
 5.1 Safetymeasurestotakebeforeusing 65
 5.2 Assemblyandswitchingonthesystem 67
 5.2.1 Additionalearthconnection 67
 5.2.2 Powersupplycableconnection 67
 5.2.3 Footswitch-stirrupopening 68
 5.2.4 Connectingthefootswitchconnectortothebodyofthedevice 68
 5.2.5 Insertionofthepolesforsupportingthephysiologicalsolution 69
 5.2.6 Switchingonthedevice 69
 5.2.7 Choiceoflanguage 70
 5.2.8 Settinguptheirrigationcircuit 70
 5.2.9 PiezosurgeryMedicalHandpiececonnection 72
 5.2.10 Operatinginstructions 74
 5.3 Congurationofthesystem 76
 5.3.1 Controls 76
 5.3.2 Settings 78
 5.3.3 Safetymeasureswhenusing 82
 5.4 Switchingoffthedevice-“SHUTDOWN” 84
6 PERIODIC MAINTENANCE 85
 6.1 Idledevice 85
 6.2 Powersupplycable 85
7 REPLACING THE FUSES 86
8 DISPOSAL PROCEDURES AND PRECAUTIONS 87
9 INSERTS 88
10 DESCRIPTION OF SHIELDS, ALARMS AND SOLUTIONS 89
11 PROBLEM-SOLVING 92
12 TECHNICAL DATA AND ELECTROMAGNETIC COMPATIBILITY 94
 12.1 Technicaldata 94
 12.2 ElectromagneticcompatibilityEN60601-1-2 95
13 GUARANTEE 99
14 PACKING 100

Manualofuseandmaintenance
EN
53
1 INTRODUCTION
1.1 Preface
Carefullyreadthismanualbeforeproceedingwithinstallationoperations,use,maintenanceorother
interventionsonthedevice.Athoroughunderstandingofthemanualisneededbeforeusingthe
devicesoastoavoidpotentialinjurytotheuserand/orpatientsand/ordamagetothedeviceitself.
Alwayskeepthismanualathand.
Important:Toavoidinjurytopeopleordamagetoproperty,carefullyreadtheparagraphson“Safety
Measures” contained in this manual. Depending on the degree of gravity, the prescriptions are
classiedwiththefollowingindications:

DANGER(alwaysreferredtoinjuriestopeople)

WARNING(referredtopossibledamagetoproperty)
The purpose of this manual is to inform the operator of the safety measures, the installation
procedures,theoperatinginstructionsandinstructionsforacorrectmaintenanceofthedevice.

DANGER
Thismanualmustbeusedinassociationwiththe“InstructionsforCleaningandSterilizing”manual
providedwiththePiezosurgeryMedicaldevice.
Ifanyanomalyisdetected,pleasecontactMectronAssistanceCentre.
Anyattempttotamperwithormodifythedevicebytheoperatorornonauthorizedpersonnelwill
invalidatetheguaranteeandrelievetheManufacturerofanyresponsibilityincaseofinjurytopeople
ordamagetoproperty.
Alltheinformationandillustrationshavebeenupdatedtothedateofissuereferredtoonthelast
page.
MECTRONhasundertakentocontinuouslyupgradeits products with possiblemodicationsand
accessories.
Inthecaseofdiscrepanciesbetweenthedescriptionscontainedinthismanualandthecomponents
ofthedevice,contactyourRetailerorMECTRON’sPost-saleService.
1.2 Type testing
AlldevicesproducedbyMectronS.p.A.arerigorouslycheckedandtypetestedineverycomponent.
Duringthistypetestingthecomponentsundergoaseriesofworkcycles.Thisprocedureguarantees
theproduct’sreliabilityinallitscomponents.
1.3 Description of the device
ThePiezosurgeryMedicaldeviceisapiezoelectricultrasounddeviceforbonecutting:thedevice
usespiezoelectricultrasoundtechnologytogeneratemechanicalmicrovibrationswhichcutthrough
mineralizedstructureswithoutdamagingthesofttissues.

54  Manualofuseandmaintenance
1.4 Intended Use
IlPiezosurgeryMedicalisapiezoelectricdeviceforbonesurgerysuppliedwithspecialinsertswhich
enablethesurgeontoapplyosteotomyandosteoplastictechniquesandtodrillholesinavarietyof
surgicalprocedures:
- Otorhinolaryngology
- Oral-maxillofacialsurgery
- Handandfootsurgery
- reconstructiveplasticsurgery.
Furthermore it is possible to execute osteotomy and osteoplastic techniques and drill holes in
neurosurgeryandsurgeryofthespinalcolumn.
Thedevicecanalsobeusedwiththeaidofvisualendoscopictechniquestocarryouttheabove
listedprocedures.
Do not use the Piezosurgery Medical device for any other purposes other than those above
mentioned.Onthecontrary,injurytothepatientsand/ortheusersortothedeviceitselfmaybe
caused.
1.5 Safety measures
Mectrondeclinesallresponsibilityfordirectorindirectinjurytopersonsordamagetopropertyinthe
followingcases:
1 Thedeviceisnotusedforthepurposeforwhichitwasdesigned.
2 Thedeviceisused not in conformitywiththeinstructions and prescriptionsdescribedinthis
manual.
3 Theelectricsystemtowhichthedeviceisconnecteddoesnotconformtotheexistinglawsand
relativeprescriptions.
4 The assembly, extension, adjustment, modication and repair operations are carried out by
personnelotherthanMectronauthorizedpersonnel.
5. The environmental conditions in which the device is kept and stored do not conform to the
prescriptionsindicatedinparagraph12.1“Technicaldata”.
6. TheinsertsusedarenotoriginalMectron.


DANGER:UsingnonoriginalMectroninsertscausespermanentdamagetothethreading
ofthehandpiecetherebyprejudicingthecorrectperformanceandriskinginjurytothepatient.In
this case the manufacturer’s guarantee and the type-approval of the device will no longer
be valid.
1.5.1 Important safety recommendations

DANGER:
Readtherecommendationsthoroughlyandrespectthesetoavoidcompromisingthesafetyofthe
patientand/oruser.Thenonobservanceoftheserecommendationsmaycauseseriousinjurytothe
patientand/oroperator.

DANGER: Qualied and specialized personnel.
The device must be used exclusively by specialized personnel opportunely trained such as the
surgeon.
Improper use may cause injury to patients and/or users and damage to the components of the
device.

WARNING:
FederalLaws(intheUnitedStatesofAmerica)limittheuseofthisdeviceonlyto,orfor,qualied
doctors.

DANGER:
Eachtimebeforeusinginspecteachcomponenttoidentifyeventualdamage.Ifdamageisdetected
donotuse.

Manualofuseandmaintenance
EN
55

DANGER: Use.
Onlyusethedeviceforthepurposeforwhichitwasdesigned(seeparagraph1.4“Useindications”).
Failuretocomplywiththisprescriptionmaycauseseriousinjurytothepatient,theoperatorand
damage/faultstothedevice.

DANGER:
TheremovablepanelplacedonthebackofthedeviceisaccessibleonlytoMectronspecialized
personnel.Usersmustnotattempttoremoveitortamperwithitasthiswouldinvalidatetheguarantee
andcoulddamagethedevice.

DANGER: Contraindications.
Do not use the Piezosurgery Medical on patients with cardiac stimulator (Pace-maker) or other
electronicimplants.Thisprescriptionisintendedalsofortheoperator.Incaseofdoubt,contactthe
produceroftheelectronicimplant.

DANGER: Interference with other devices.
Theelectrosurgicallancetmayinterferewiththecorrectfunctioningofthedevice.

DANGER: Interference with other devices.
Il Piezosurgery Medical could emit frequencies which interfere with other devices in the vicinity.
InstallthePiezosurgeryMedicaldeviceatanappropriatedistancefromlifesupportdevice.Before
operatingalwayscheckthecorrectfunctioningofalldevices.

DANGER:
Donotinstallthedeviceinplaceswherethereisariskofexplosion.Thedeviceisnotdesignedto
operateinenvironmentsinwhichthereareammableatmospheres(anestheticmixtures,oxygen,
etc.).

DANGER: Always check the device before treatment.
- Alwayscheckthatthereisnowaterbeneaththedevice.
- Beforeusingfortreatment,checkthatthedeviceisfunctioningproperlyandthattheaccessories
areefcient.
Ifanomaliesin function aredetected,do not starttreatment.If the anomaliesregard the device,
contactMectron’sauthorizedtechnicalassistance.

DANGER: Cleaning and sterilizing.
Allneworrepairedproductsaredeliveredun-sterilized.Beforeusingfortreatmentalltheseproducts
mustbecleanedandsterilizedscrupulouslyfollowingtheinstructionscontainedinthe“Instructions
for Cleaning and Sterilizing” manual provided with the Piezosurgery Medical device.After each
treatment,andbeforeusingagain,itisnecessarytorepeattheprocedureforallaccessoriesused.

DANGER:
OnlyuseoriginalPiezosurgeryMedicalpowercables,accessoriesandspares.

DANGER:
Donotactivatethedeviceifthehandpieceisfaultyorbroken.Immediatelyreplacethehandpiece.

DANGER:
Iftheperistalticpumpisfaulty,usetheotherchannel.

DANGER:
Theelectricsystemofthepremisesinwhichthedeviceisinstalledandusedmustconformtothe
lawsinforceandtherelativeprescriptionsregardingelectricalsafety.

DANGER: Inserts with water irrigation.
Checktheirrigationreleasebeforeandduringuse.Makesuretheliquidcomesoutoftheinsert’s
point.
Donotusethedeviceifthephysiologicalsolutionisnotreleasedorthepumpisfaulty.

56  Manualofuseandmaintenance

DANGER: Injury to people.
Makesurethecablesdonothinderthefreepassageofpeople.

DANGER: Injury to people.
Whentheperistalticpumpapisopen(Pic.12-Ref.C)donotactivatethePiezosurgeryMedical
footswitch.Themovingpartscouldinjuretheoperator.

WARNING:
Donotusepointedorsharpobjectsonthelcdscreen.ThiscoulddamagetheTouchScreenorthe
screenitself.Alightpressureofthenger,eveninalatexglove,allowstheoperatortochoosethe
desiredsettings.

WARNING: Contraindication.
Do not use to treat metal or ceramic prostheses. The ultrasound vibrations could cause the de-
cementationoftheprostheses.
1.6 Symbols used

WARNING,Seeinstructionsforuse
Type“B”appliedpartinconformitywithtechnicalnormEN60601-1
Serialnumber
Lotnumber
Productcode
Manufacturer
0476
Device manufactured in conformity with directive 93/42/EEC including
technicalnormsEN60601-1andEN60601-1-2.Cermetnotiedbody.
METTrademark
UL 60601-1 CSA C22.2
No. 601-1 - E113015 ConformitytonormsUL-CSA

Manualofuseandmaintenance
EN
57
Thedeviceanditsaccessoriesmustnotbedisposedofortreatedassolid
urbanwaste
Footswitchconnector
Maybesterilizedatamaximumtemperatureof135°C
AlternateCurrent
Donottouchthemovingpartswithyourngers
QTY. Quantityofproductinthepacking
Nonsterile
Expirydate
Productiondate
Sterilizedwithethyleneoxide
Disposable
Donotuseiftheconfectionisdamaged
Theproductismadewithcomponentsthatdonotcontainlatex

58  Manualofuseandmaintenance
2 IDENTIFICATION DATA
Aprecisedescriptionofthemodelandindicationoftheserialnumberofthedevicewillenableprompt
andeffectiveanswersfromourPost-SalesService.
AlwaysrefertothisdatawhencontactingMectron’sTechnicalAssistanceService.
2.1 Piezosurgery Medical device identication
EachdeviceisprovidedwithanIDtag(Pic.1)whichgivesthetechnicalcharacteristicsandtheserial
number.ThisIDtagisplacedonthebackofthedevice.Furtherinformationiscontainedinparagraph
12.1“Technicaldata”.
2.2 Piezosurgery Medical handpiece identication
TheserialnumberofthePiezosurgeryMedicalhandpieceisengravedonthehandpiece’smetalring
(Pic.2-Ref.A)inthefollowingform:NNNAANNN.
Pic.2
A
Pic.1
Manufacturer
Mectron S.p.A.
Via Loreto 15/a
16042 Carasco -GE- Italy
401 AB 000 made in Italy

PIEZOSURGERY Medical
100-240 V~ 200 VA - 50/60 Hz.
Intermittent operation UL 60601-1 CSA C22.2
No. 601-1 - E113015

Manualofuseandmaintenance
EN
59
3 DELIVERY
3.1 Delivery of the device
Thedevicecontainselectroniccomponentswhichcouldbedamagedifknockedabout,evenwhen
properlypacked.Thereforetransportandstockingmustbehandledwithparticularcare.
Donotputonecartonontopofanothertoavoidcrushingtheonesunderneath.
AllgoodsforwardedbyMECTRONhavebeencarefullycheckedbeforesending.
Thedeviceisdeliveredopportunelyprotectedandpacked.
Onreceiptofthedevice,checkforanyeventualdamageoccurredduringtransportandifso,issue
acomplainttothehaulingrm.
3.2 Standard list of materials supplied
ThePiezosurgeryMedicaldevicecomeswithaseriesofaccessories:
1xDeviceunit(Pic.3-Ref.A).
1xFootswitchwithcableandpinjack(Pic.3-Ref.G).
2xPeristalticpump(Pic.3-Ref.D)
1xElectricsupplycable(Pic.3-Ref.H).
2xBagsupportpole(Pic.3-Ref.F).
1xOperatinginstructionsmanual.
1xCleaningandSterilizinginstructionsmanual
Thislistmayvaryduringpromotionalcampaigns.
3.3 Accessories
ThefollowingaccessoriesaresoldseparatelyfromthePiezosurgeryMedicaldevice.
Sterileaccessories(disposable):
- Inserts(Pic.3-Ref.B)
- PiezosurgeryMedicalIrrigationKit(Pic.3-Ref.I).
Nonsterileaccessories(multipurpose):
- PiezosurgeryMedicalhandpiecescompletewithcord(Pic.3-Ref.E)andconnectorprotective
cap.
- PiezosurgeryMedicaldynamometrickeys(forxingtheinsertstothehandpiece)(Pic.3-Ref.C).

60  Manualofuseandmaintenance
Pic.3
A
B C
D E
F G I
H

Manualofuseandmaintenance
EN
61
4 INSTALLATION
4.1 Safety measures to apply in the installation phase

DANGER: Interference with other devices.
Il Piezosurgery Medical could emit frequencies which interfere with other devices in the vicinity.
Installthe PiezosurgeryMedical device at an appropriate distance fromthe lifesupport devices.
Beforeoperatingalwayscheckthecorrectfunctioningofalldevices.

DANGER:
Theelectricsystemofthepremisesinwhichthedeviceisinstalledandusedmustconformtothe
lawsinforceandtherelativeprescriptionsrelativetoelectricalsafety.

DANGER:
Donotinstallthedeviceinplaceswherethereisariskofexplosion.Thedeviceisnotdesignedto
operateinenvironmentsinwhichthereareammableatmospheres(anestheticmixtures,oxygen,
etc.).

DANGER:
Installthedeviceinaplacewhereitisprotectedfrombeingknockedaboutand/orfromaccidental
sprayofwaterorotherliquids.

DANGER:
Donotinstallthedeviceaboveornearsourcesofheat.
Whileinstalling,makesurethereisadequateaircirculationaroundthedevice.Donotcovertheslits
foraircirculationplacedonthebackofthescreen.

WARNING:
DonotexposethedevicetodirectsunlightorUVsourcesoflight.

WARNING:
Thedevicemaybetransportedbutitisnecessarytohandlewithgreatcarewhenitismoved.During
transport position the footswitch o the ground in such a manner that it can only be intentionally
activatedbytheoperator.

WARNING:
Assoonasthesterilizationcycleiscompletedandbeforeconnectingthehandpiecetothebodyof
thedevice,makesuretheelectricalcontactsofthehandpiececordconnectorareperfectlydry.If
necessary,drythecontactsbyblowingcompressedairformedicaluse.

WARNING:
Donotusepointedorsharpobjectsonthelcdscreen.ThiscoulddamagetheTouchScreenorthe
screenitself.Alightpressureofthenger,eveninalatexglove,allowstheoperatortochoosethe
desiredsettings.

WARNING:
Donotletthedevicebodyorthefootswitchtogetwet.Ifliquidweretoseepintothedevicebodyor
footswitch,thiscouldcausedamage.

62  Manualofuseandmaintenance
4.2 First installation

WARNING:
Removealltheaccessoriesbeforeextractingthedevicebody.
NOTE:AfterunpackingthePiezosurgeryMedicaldevice,keepthecartonsandpackingmaterial.If
thedeviceneedstobesentfromoneplaceoanotherthepackingmaterialpurposelydesignedfor
thisdevicewillprovidesuitableprotection.
In order to guarantee a perfect performance of the device, this must be installed by a Mectron
authorizedtechnician.Thedevicemustbeinstalledinasuitableandspaciousplace.
Thetechnicianmustcarryoutthefollowing5points:
1. Unpackthedeviceasshowninthefollowingpicture(Pic.4).
7
123
45
6Pic.4

Manualofuseandmaintenance
EN
63
2. Installthe2peristalticpumpsasfollows:
-Slightly push the peristaltic pump’s head towards the corresponding base (placed on the
device)(Pic.5).
Pic.5
-Gentlyrotatethepump’sheadbackwardsandforwardstomatchthetwoparts.
-Rotateclockwiseuntilthepump’sheadblockswitha“CLICK”andsettlesinaverticalposition
(Pic.6).
CLICK!
Pic.6
-Gentlypullthepump’sheadtomakesurethepumpispositionedcorrectly.
3. Explainto the user the safetymeasures tobe considered for the installationto beexecuted
correctly.
4. Fillintheinstallationform(includingthepurchaser’sdata).
5. SendthecompiledinstallationmoduletoMectronS.p.A.inordertoguaranteethetraceabilityof
thedeviceandtheactivationoftheguarantee.

64  Manualofuseandmaintenance
5 ASSEMBLY, CONFIGURATION AND USE
5.1 Safety measures to take before using

DANGER: Qualied and specialized personnel.
The device must be used exclusively by specialized personnel opportunely trained such as the
surgeon.
Improper use may cause injury to patients and/or users and damage to the components of the
device.

DANGER: Use.
Onlyusethedeviceforthepurposeforwhichitwasdesigned(seeparagraph1.4“Use”).Failureto
complywiththisprescriptionmaycauseseriousinjurytothepatient,theoperatoranddamage/faults
tothedevice.

DANGER:
DANGER:
Checkthelevelofphysiologicalsolutioncontainedinthesolutionbag.
Replacethesolutionbagwithanewonebeforeitiscompletelyempty.

DANGER: Contraindications.
DonotusethePiezosurgeryMedicaldeviceonpatientswithcardiacstimulators(pace-makers)or
otherelectronicimplantdevices.
This prescription concerns also the operator. In case of doubt, contact the manufacturer of the
implantdevice.

DANGER: Interference with other devices.
Theelectrosurgicallancetmayinterferewiththecorrectfunctioningofthedevice.

DANGER: Interference with other devices.
Il Piezosurgery Medical could emit frequencies which interfere with other devices in the vicinity.
InstallthePiezosurgeryMedicaldeviceatanappropriatedistancefromlifesupportdevices.Before
operatingalwayscheckthecorrectfunctioningofalldevices.

DANGER: Check the state of the device before using for treatment.
- Alwayscheckthatthereisnowaterbeneaththedevice.
- Beforeusingfortreatment,checkthatthedeviceisfunctioningproperlyandthattheaccessories
areefcient.
Ifanomaliesin function aredetected,do not starttreatment.If the anomaliesregard the device,
contactMectron’sauthorizedtechnicalassistance.

DANGER: Clean and sterilize the products supplied.
Allproducts(neworrepaired)aredeliveredun-sterilized.
Beforeusingfortreatmentalltheseproductsmustbecleanedandsterilizedscrupulouslyfollowing
theinstructionscontainedinthe“InstructionsforCleaningandSterilizing”manual.

DANGER: Clean and sterilize before using.
Afterusing,allreusableaccessories(handpieceanddynamometrickey)mustbecarefullycleaned
and sterilized each time before using again, as indicated in the “Instructions for Cleaning and
Sterilizing”manualsuppliedtogetherwiththePiezosurgeryMedicaldevice.

DANGER: Clean and sterilize before surgery.
Makesurethatallreusableaccessories(handpieceanddynamometrickey)havebeencleanedand
sterilizedbeforeusing.Donotuseiftheyhavenotbeensterilized.

DANGER:
OnlyuseoriginalMectronpowercables,accessoriesandspares.

Manualofuseandmaintenance
EN
65

DANGER:
Donotactivatethedeviceifthehandpieceisfaultyorbroken.Immediatelyreplacethehandpiece.

DANGER:
Iftheperistalticpumpisfaulty,usetheotherchannel.

DANGER: Inserts with water irrigation.
Checktheirrigationreleasebeforeandduringuse.Makesuretheliquidcomesoutoftheinsert’s
point.
Donotusethedeviceifthephysiologicalsolutionisnotreleasedorthepumpisfaulty.

DANGER: Injury to people.
Makesurethecablesdonothinderthefreepassageofpeople.

DANGER: Injury to people.
Whentheperistalticpumpapisopen(Pic.12-Ref.C)donotactivatethePiezosurgeryMedical
footswitch.Themovingpartscouldinjuretheoperator.

WARNING:
Donotusepointedorsharpobjectsonthelcdscreen.Thiscoulddamagethetouchscreenorthe
screenitself.Alightpressureofthenger,eveninalatexglove,allowstheoperatortochoosethe
desiredsettings.

WARNING: Contraindication.
Do not use to treat metal or ceramic prostheses. The ultrasound vibrations could cause the de-
cementationoftheprostheses.

DANGER:
Beforesurgery,makesuretheinsertiscorrectlyxedtothehandpiece.

DANGER:
Checkthattheinsertxedtothehandpieceisthesameastheoneselectedonthedisplay,otherwise
anoptimalperformancemaynotbeobtained.

DANGER:
ThePiezosurgeryMedicaldeviceisandeviceusedinbonesurgery.Howeveraprolongedcontact
and/or excessive force of the inserts on soft tissues should be avoided because these could
causeburnsand/ornoncutlesions.Useparticularcautionwhenusingsharpinserts.Aprolonged
mechanicaluseofsharpinsertscouldcutthroughthesofttissues.Whenusinginproximityofsoft
tissues/nerves(forexampletheperineviumoftheperipheralnervoussystemortheduramaterof
thecentralnervoussystem)itishighlyrecommendedtonishthecutwithabluntdiamondinsertin
ordertominimizethepotentialriskofdamagingthesetissues.

66  Manualofuseandmaintenance
5.2 Assembly and switching on the system
Beforeoperatingitisnecessarytoassemblethesystemasdescribedinthefollowingsteps:
5.2.1 Additional earth connection
- Ifrequired,insertadditionalearthingtothecorrespondingconnector(Pic.7-Ref.A).
5.2.2 Power supply cable connection
- Insertthepowersupplyconnectorintheconnectorplacedonthebackofthedevice(Pic.7-
Ref.B)andthentothewallsocket.
Pic.7
C
AB
D
E
Pic.8
A
B

Manualofuseandmaintenance
EN
67
5.2.3 Footswitch - stirrup opening

WARNING:
ThefootswitchisspecicallydesignedtobeusedonlywiththePiezosurgeryMedicaldevice.Only
useoriginalPiezosurgeryMedicalfootswitchasotherwisedamageormalfunctionmayoccur.
- Rotatethemetalstirrupuntilitisxedinverticalposition(Pic.8-Ref.A).
- Rotateandmanuallyfastenthelateralclampstosecurethestirrupinthecorrectposition(Pic.8
-Ref.B).
5.2.4 Connecting the footswitch connector to the body of the device.
- Insert the connector of the footswitch cable into the corresponding connector placed on the
backofthedeviceandmarkedwiththespecialsymbolasindicatedinPic.9.Todisconnectthe
footswitchfromthedevicebody,holdtheconnector,pressthereleasetabandpullback.

WARNING:
Donotattempttotwistorrotatetheconnectorofthefootswitchcablewhileinsertingorremoving.
Twistingmaydamagetheconnector.

WARNING:
Toavoiddamagingthefootswitchcable,connectand/ordisconnectalwaysholdingonlytheconnector.

WARNING:
Alwayscheckbeforeandafterusethatthefootswitch,thecableanditsconnectorarenotdamaged.
Ifdamageisdetecteddonotusethefootswitch.
Pic.9

68  Manualofuseandmaintenance
5.2.5 Insertion of the poles for supporting the physiological solution
- Insertthepolesforsupportingthephysiologicalsolutionintheappropriateholesinthedevice
(Pic.10).
Pic.10
5.2.6 Switching on the device
- Switchonthedevicewiththemainswitchplacedonthebackofthedevice(Pic.7-Ref.C)making
surethefootswitchisnotpressedduringthisprocedure.Thedevicethusswitcheson.

Manualofuseandmaintenance
EN
69
5.2.7 Choice of language
Aftertheentiresystemhasbeenchecked,thefollowingdisplayappears:(Pic.11).
Thersttimethedeviceisswitchedon,thepresetlanguageistheEnglishlanguage.Ifadifferent
languageisrequired:
- Pressthe“LANGUAGE”button(Pic.11-Ref.A).
- Selecttheagcorrespondingtothedesiredlanguage.
- Press“RETURN”:theselectedlanguagewillthenbethepresetlanguagewhichwillremainthe
sameuntilanewselectionismade.
NOTE:Thelanguagemaybemodiedonlywhenthethereisnohandpieceinsertedinthedevice.
Pic.11
A
5.2.8 Setting up the irrigation circuit
A. OPERATIONS TO CARRY OUT IN STERILE CONDITIONS:

DANGER:
ThePiezosurgeryMedicalIrrigationKitisguaranteedforasingleuse.Segregateanddisposeofthe
kitaccordingtothelawsinforceregulatinghospitalwaste.

DANGER:
BeforeusingthePiezosurgeryMedicalIrrigationKit,checktheintegrityofthesterilepackingand
carefullyinspecttheproducttoexcludeanyeventualdamageorfaults.Donotusetheirrigationkitif
thepackinghasbeentamperedwithordamaged.
Theirrigationkitlosesitssterileconditionifthepackingisbroken or damaged. If the packing is
damaged,disposeofthekit.Donotattempttosterilizeorreusethekit.

70  Manualofuseandmaintenance

DANGER: Contraindications.
CheckthatthePiezosurgeryMedicalhandpiecehasbeencleanedandsterilizedbeforeusing.Ifit
isn’t,donotuse.

DANGER:
ThePiezosurgeryMedicalhandpiece(neworserviced)isnotsterilewhenitissuppliedandmust
thereforebecarefullycleanedandsterilized(withtheautoclave)beforeusing.

DANGER:
AftersterilizingthePiezosurgeryMedicalhandpieceintheautoclave,waituntilithascooleddown
beforeusing.

WARNING:
Whenthesterilizationcycleiscompleteandbeforeconnectingthehandpiecetothedevicebody,
makesuretheelectricalcontactsofthehandpiece-cordconnectorareperfectlydry.Ifnecessary,dry
thecontactsbyblowingcompressedairformedicaluse.

DANGER:
After using, each handpiece-cord must be thoroughly cleaned and sterilized before using again,
followingtheinstructionscontainedinthe “CleaningandSterilizingInstructions”manualsupplied
withthePiezosurgeryMedicaldevice.

DANGER:
Alwayscheck,beforeandafterusing,thatthehandpieceanditscordarenotdamaged.Ifdamageis
detected,donotusethehandpiece-cord.
Pic.12
A
B
C
D