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
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FR
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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

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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
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
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

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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
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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