mectron Piezosurgery - Safety Measures and Recommendations

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 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.