mectron Piezosurgery Manuale utente
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
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52 Manualofuseandmaintenance
Table of contents
1 INTRODUCTION 54
1.1 Preface 54
1.2 Typetesting 54
1.3 Descriptionofthedevice 54
1.4 IntendedUse 55
1.5 IntendedUse 55
1.5.1 Importantsafetyrecommendations 55
1.6 Symbolsused 57
2 IDENTIFICATION DATA 59
2.1 PiezosurgeryMedicaldeviceidentication 59
2.2 PiezosurgeryMedicalhandpieceidentication 59
3 DELIVERY 60
3.1 Deliveryofthedevice 60
3.2 Standardlistofmaterialssupplied 60
3.3 Accessories 60
4 INSTALLATION 62
4.1 Safetymeasurestoapplyintheinstallationphase 62
4.2 Firstinstallation 63
5 ASSEMBLY, CONFIGURATION AND USE 65
5.1 Safetymeasurestotakebeforeusing 65
5.2 Assemblyandswitchingonthesystem 67
5.2.1 Additionalearthconnection 67
5.2.2 Powersupplycableconnection 67
5.2.3 Footswitch-stirrupopening 68
5.2.4 Connectingthefootswitchconnectortothebodyofthedevice 68
5.2.5 Insertionofthepolesforsupportingthephysiologicalsolution 69
5.2.6 Switchingonthedevice 69
5.2.7 Choiceoflanguage 70
5.2.8 Settinguptheirrigationcircuit 70
5.2.9 PiezosurgeryMedicalHandpiececonnection 72
5.2.10 Operatinginstructions 74
5.3 Congurationofthesystem 76
5.3.1 Controls 76
5.3.2 Settings 78
5.3.3 Safetymeasureswhenusing 82
5.4 Switchingoffthedevice-“SHUTDOWN” 84
6 PERIODIC MAINTENANCE 85
6.1 Idledevice 85
6.2 Powersupplycable 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 Technicaldata 94
12.2 ElectromagneticcompatibilityEN60601-1-2 95
13 GUARANTEE 99
14 PACKING 100
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1 INTRODUCTION
1.1 Preface
Carefullyreadthismanualbeforeproceedingwithinstallationoperations,use,maintenanceorother
interventionsonthedevice.Athoroughunderstandingofthemanualisneededbeforeusingthe
devicesoastoavoidpotentialinjurytotheuserand/orpatientsand/ordamagetothedeviceitself.
Alwayskeepthismanualathand.
Important:Toavoidinjurytopeopleordamagetoproperty,carefullyreadtheparagraphson“Safety
Measures” contained in this manual. Depending on the degree of gravity, the prescriptions are
classiedwiththefollowingindications:
DANGER(alwaysreferredtoinjuriestopeople)
WARNING(referredtopossibledamagetoproperty)
The purpose of this manual is to inform the operator of the safety measures, the installation
procedures,theoperatinginstructionsandinstructionsforacorrectmaintenanceofthedevice.
DANGER
Thismanualmustbeusedinassociationwiththe“InstructionsforCleaningandSterilizing”manual
providedwiththePiezosurgeryMedicaldevice.
Ifanyanomalyisdetected,pleasecontactMectronAssistanceCentre.
Anyattempttotamperwithormodifythedevicebytheoperatorornonauthorizedpersonnelwill
invalidatetheguaranteeandrelievetheManufacturerofanyresponsibilityincaseofinjurytopeople
ordamagetoproperty.
Alltheinformationandillustrationshavebeenupdatedtothedateofissuereferredtoonthelast
page.
MECTRONhasundertakentocontinuouslyupgradeits products with possiblemodicationsand
accessories.
Inthecaseofdiscrepanciesbetweenthedescriptionscontainedinthismanualandthecomponents
ofthedevice,contactyourRetailerorMECTRON’sPost-saleService.
1.2 Type testing
AlldevicesproducedbyMectronS.p.A.arerigorouslycheckedandtypetestedineverycomponent.
Duringthistypetestingthecomponentsundergoaseriesofworkcycles.Thisprocedureguarantees
theproduct’sreliabilityinallitscomponents.
1.3 Description of the device
ThePiezosurgeryMedicaldeviceisapiezoelectricultrasounddeviceforbonecutting:thedevice
usespiezoelectricultrasoundtechnologytogeneratemechanicalmicrovibrationswhichcutthrough
mineralizedstructureswithoutdamagingthesofttissues.
54 Manualofuseandmaintenance
1.4 Intended Use
IlPiezosurgeryMedicalisapiezoelectricdeviceforbonesurgerysuppliedwithspecialinsertswhich
enablethesurgeontoapplyosteotomyandosteoplastictechniquesandtodrillholesinavarietyof
surgicalprocedures:
- Otorhinolaryngology
- Oral-maxillofacialsurgery
- Handandfootsurgery
- reconstructiveplasticsurgery.
Furthermore it is possible to execute osteotomy and osteoplastic techniques and drill holes in
neurosurgeryandsurgeryofthespinalcolumn.
Thedevicecanalsobeusedwiththeaidofvisualendoscopictechniquestocarryouttheabove
listedprocedures.
Do not use the Piezosurgery Medical device for any other purposes other than those above
mentioned.Onthecontrary,injurytothepatientsand/ortheusersortothedeviceitselfmaybe
caused.
1.5 Safety measures
Mectrondeclinesallresponsibilityfordirectorindirectinjurytopersonsordamagetopropertyinthe
followingcases:
1 Thedeviceisnotusedforthepurposeforwhichitwasdesigned.
2 Thedeviceisused not in conformitywiththeinstructions and prescriptionsdescribedinthis
manual.
3 Theelectricsystemtowhichthedeviceisconnecteddoesnotconformtotheexistinglawsand
relativeprescriptions.
4 The assembly, extension, adjustment, modication and repair operations are carried out by
personnelotherthanMectronauthorizedpersonnel.
5. The environmental conditions in which the device is kept and stored do not conform to the
prescriptionsindicatedinparagraph12.1“Technicaldata”.
6. TheinsertsusedarenotoriginalMectron.
DANGER:UsingnonoriginalMectroninsertscausespermanentdamagetothethreading
ofthehandpiecetherebyprejudicingthecorrectperformanceandriskinginjurytothepatient.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:
Readtherecommendationsthoroughlyandrespectthesetoavoidcompromisingthesafetyofthe
patientand/oruser.Thenonobservanceoftheserecommendationsmaycauseseriousinjurytothe
patientand/oroperator.
DANGER: Qualied 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:
FederalLaws(intheUnitedStatesofAmerica)limittheuseofthisdeviceonlyto,orfor,qualied
doctors.
DANGER:
Eachtimebeforeusinginspecteachcomponenttoidentifyeventualdamage.Ifdamageisdetected
donotuse.
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DANGER: Use.
Onlyusethedeviceforthepurposeforwhichitwasdesigned(seeparagraph1.4“Useindications”).
Failuretocomplywiththisprescriptionmaycauseseriousinjurytothepatient,theoperatorand
damage/faultstothedevice.
DANGER:
TheremovablepanelplacedonthebackofthedeviceisaccessibleonlytoMectronspecialized
personnel.Usersmustnotattempttoremoveitortamperwithitasthiswouldinvalidatetheguarantee
andcoulddamagethedevice.
DANGER: Contraindications.
Do not use the Piezosurgery Medical on patients with cardiac stimulator (Pace-maker) or other
electronicimplants.Thisprescriptionisintendedalsofortheoperator.Incaseofdoubt,contactthe
produceroftheelectronicimplant.
DANGER: Interference with other devices.
Theelectrosurgicallancetmayinterferewiththecorrectfunctioningofthedevice.
DANGER: Interference with other devices.
Il Piezosurgery Medical could emit frequencies which interfere with other devices in the vicinity.
InstallthePiezosurgeryMedicaldeviceatanappropriatedistancefromlifesupportdevice.Before
operatingalwayscheckthecorrectfunctioningofalldevices.
DANGER:
Donotinstallthedeviceinplaceswherethereisariskofexplosion.Thedeviceisnotdesignedto
operateinenvironmentsinwhichthereareammableatmospheres(anestheticmixtures,oxygen,
etc.).
DANGER: Always check the device before treatment.
- Alwayscheckthatthereisnowaterbeneaththedevice.
- Beforeusingfortreatment,checkthatthedeviceisfunctioningproperlyandthattheaccessories
areefcient.
Ifanomaliesin function aredetected,do not starttreatment.If the anomaliesregard the device,
contactMectron’sauthorizedtechnicalassistance.
DANGER: Cleaning and sterilizing.
Allneworrepairedproductsaredeliveredun-sterilized.Beforeusingfortreatmentalltheseproducts
mustbecleanedandsterilizedscrupulouslyfollowingtheinstructionscontainedinthe“Instructions
for Cleaning and Sterilizing” manual provided with the Piezosurgery Medical device.After each
treatment,andbeforeusingagain,itisnecessarytorepeattheprocedureforallaccessoriesused.
DANGER:
OnlyuseoriginalPiezosurgeryMedicalpowercables,accessoriesandspares.
DANGER:
Donotactivatethedeviceifthehandpieceisfaultyorbroken.Immediatelyreplacethehandpiece.
DANGER:
Iftheperistalticpumpisfaulty,usetheotherchannel.
DANGER:
Theelectricsystemofthepremisesinwhichthedeviceisinstalledandusedmustconformtothe
lawsinforceandtherelativeprescriptionsregardingelectricalsafety.
DANGER: Inserts with water irrigation.
Checktheirrigationreleasebeforeandduringuse.Makesuretheliquidcomesoutoftheinsert’s
point.
Donotusethedeviceifthephysiologicalsolutionisnotreleasedorthepumpisfaulty.
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DANGER: Injury to people.
Makesurethecablesdonothinderthefreepassageofpeople.
DANGER: Injury to people.
Whentheperistalticpumpapisopen(Pic.12-Ref.C)donotactivatethePiezosurgeryMedical
footswitch.Themovingpartscouldinjuretheoperator.
WARNING:
Donotusepointedorsharpobjectsonthelcdscreen.ThiscoulddamagetheTouchScreenorthe
screenitself.Alightpressureofthenger,eveninalatexglove,allowstheoperatortochoosethe
desiredsettings.
WARNING: Contraindication.
Do not use to treat metal or ceramic prostheses. The ultrasound vibrations could cause the de-
cementationoftheprostheses.
1.6 Symbols used
WARNING,Seeinstructionsforuse
Type“B”appliedpartinconformitywithtechnicalnormEN60601-1
Serialnumber
Lotnumber
Productcode
Manufacturer
0476
Device manufactured in conformity with directive 93/42/EEC including
technicalnormsEN60601-1andEN60601-1-2.Cermetnotiedbody.
METTrademark
UL 60601-1 CSA C22.2
No. 601-1 - E113015 ConformitytonormsUL-CSA
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Thedeviceanditsaccessoriesmustnotbedisposedofortreatedassolid
urbanwaste
Footswitchconnector
Maybesterilizedatamaximumtemperatureof135°C
AlternateCurrent
Donottouchthemovingpartswithyourngers
QTY. Quantityofproductinthepacking
Nonsterile
Expirydate
Productiondate
Sterilizedwithethyleneoxide
Disposable
Donotuseiftheconfectionisdamaged
Theproductismadewithcomponentsthatdonotcontainlatex
58 Manualofuseandmaintenance
2 IDENTIFICATION DATA
Aprecisedescriptionofthemodelandindicationoftheserialnumberofthedevicewillenableprompt
andeffectiveanswersfromourPost-SalesService.
AlwaysrefertothisdatawhencontactingMectron’sTechnicalAssistanceService.
2.1 Piezosurgery Medical device identication
EachdeviceisprovidedwithanIDtag(Pic.1)whichgivesthetechnicalcharacteristicsandtheserial
number.ThisIDtagisplacedonthebackofthedevice.Furtherinformationiscontainedinparagraph
12.1“Technicaldata”.
2.2 Piezosurgery Medical handpiece identication
TheserialnumberofthePiezosurgeryMedicalhandpieceisengravedonthehandpiece’smetalring
(Pic.2-Ref.A)inthefollowingform: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
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3 DELIVERY
3.1 Delivery of the device
Thedevicecontainselectroniccomponentswhichcouldbedamagedifknockedabout,evenwhen
properlypacked.Thereforetransportandstockingmustbehandledwithparticularcare.
Donotputonecartonontopofanothertoavoidcrushingtheonesunderneath.
AllgoodsforwardedbyMECTRONhavebeencarefullycheckedbeforesending.
Thedeviceisdeliveredopportunelyprotectedandpacked.
Onreceiptofthedevice,checkforanyeventualdamageoccurredduringtransportandifso,issue
acomplainttothehaulingrm.
3.2 Standard list of materials supplied
ThePiezosurgeryMedicaldevicecomeswithaseriesofaccessories:
1xDeviceunit(Pic.3-Ref.A).
1xFootswitchwithcableandpinjack(Pic.3-Ref.G).
2xPeristalticpump(Pic.3-Ref.D)
1xElectricsupplycable(Pic.3-Ref.H).
2xBagsupportpole(Pic.3-Ref.F).
1xOperatinginstructionsmanual.
1xCleaningandSterilizinginstructionsmanual
Thislistmayvaryduringpromotionalcampaigns.
3.3 Accessories
ThefollowingaccessoriesaresoldseparatelyfromthePiezosurgeryMedicaldevice.
Sterileaccessories(disposable):
- Inserts(Pic.3-Ref.B)
- PiezosurgeryMedicalIrrigationKit(Pic.3-Ref.I).
Nonsterileaccessories(multipurpose):
- PiezosurgeryMedicalhandpiecescompletewithcord(Pic.3-Ref.E)andconnectorprotective
cap.
- PiezosurgeryMedicaldynamometrickeys(forxingtheinsertstothehandpiece)(Pic.3-Ref.C).
60 Manualofuseandmaintenance
Pic.3
A
B C
D E
F G I
H
Altri manuali per Piezosurgery
2
Indice
Altri manuali mectron Attrezzature mediche
