Mectron Piezosurgery flex Bedienungsanleitung

USE AND MAINTENANCE MANUAL

GEBRAUCHS- UND WARTUNGSANLEITUNG

MANUALE D’USO E MANUTENZIONE

MODE D’EMPLOI ET D’ENTRETIEN

MANUAL DE USO Y MANTENIMIENTO

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0051

L M

USE AND MAINTENANCE MANUAL

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form without the written consent of the copyright owner.

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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

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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

;

• 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.).

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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

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