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mectron compact piezo P2K, Руководство по эксплуатации и обслуживанию

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6

COMPACT PIEZO P2K

1.5 

Symbols

Symbol

Description

Symbol

Description

0051

Device compliant 

with Regulation (EU) 

2017/745. Notified 

body: IMQ S.p.A.

Nemko brand

Compliance with UL - 

CSA regulations

Medical device

Caution! Read the 

instructions for use

Operating instructions

Manufacturer

Date of manufacture

Serial number

Batch number

Product code

Not sterile

The sterilisable 

materials must be 

autoclaved and can 

resist up to a maximum 

temperature of 135°C

“B” Part applied 

according to regulation 

EN 60601-1

Hazardous voltage

Alternating current

Continuous current

Generic warning signal 

a)

The appliance and its 

accessories must not be 

disposed of or treated 

as municipal solid waste

Temperature limits for 

transport and storage

Moisture limits for 

transport and storage

Atmospheric pressure 

limits for transport and 

storage

QTY.1

Quantity in package: 1

Содержание compact piezo P2K

Страница 1: ...0051 USE AND MAINTENANCE MANUAL COMPACT PIEZO P2K...

Страница 2: ...COMPACT PIEZO P2K...

Страница 3: ...I Copyright Mectron S p A 2021 All rights reserved No part of this document may be reproduced in any form whatsoever without the prior written consent of the copyright holder...

Страница 4: ...Accessories 19 6 1 1 Manual Cleaning 19 6 1 1 1 Required Materials 19 6 1 1 2 Scaler Handpiece 20 6 1 1 3 Inserts 21 6 1 1 4 Inserts Tightening Wrench 24 6 1 2 Automatic Cleaning 25 6 1 2 1 Required M...

Страница 5: ...e tests for the Immunity of the Accessible Parts of the Casing to the Wireless RF Communications Device 39 10 Troubleshooting 40 10 1 Quick Troubleshooting 40 10 2 Shipping to an Authorised Mectron Se...

Страница 6: ...IV COMPACT PIEZO P2K PAGE LEFT INTENTIONALLY BLANK...

Страница 7: ...of the MECTRON website1 ask clarifications to Your Dealer contact MECTRON After Sales Service 1 1 Intended Use With the appropriate inserts it is possible to perform the following treatments Scaling...

Страница 8: ...t groups Children Adolescents Adults Seniors This medical device can be used on patients of any age weight height gender and nationality where applicable 1 2 2 Patient Selection Criteria It is not rec...

Страница 9: ...e equipment is used do not comply with the laws in force and the related regulations Assembly operations extensions re adjustments upgrades and repairs of the device are carried out by personnel not a...

Страница 10: ...oom or surgery in order to comply with mandatory requirements must periodically inspect the equipment present in the surgery the test procedures to apply to medical electrical equipment and medical el...

Страница 11: ...rter than the limit of wear its performance will be significantly inferior compared to that of a new insert and should therefore be replaced If the layer of titanium nitride gold plated surface where...

Страница 12: ...mber Product code Not sterile The sterilisable materials must be autoclaved and can resist up to a maximum temperature of 135 C B Part applied according to regulation EN 60601 1 Hazardous voltage Alte...

Страница 13: ...ime that you contact MECTRON After Sales Service 2 1 Scaler Handpiece Identification Data The handpiece name MECTRON logo serial number product code HIBC matrix code and a series of symbols are laser...

Страница 14: ...client Standard supply Item Code Description Ref Device core unit 04000079 A Cord 02830084 B Scaler Handpiece 03120016 SCALER HAND PIECE C Table 2 Standard supply Accessories available for order with...

Страница 15: ...inserts b 03590001 TA12D60 diamond insert b 03590004 TA12D90 diamond insert b 03590002 TA14D60 diamond insert b 03590005 TA14D90 diamond insert b 03590007 TA14D120 diamond insert b 03590003 TA16D60 d...

Страница 16: ...out F b 01560101 Layout G b 01560141 Layout H b Use and Maintenance Manual 02150174 IT version b G 02150175 EN version b 02150176 DE version b 02150177 FR version b 02150178 ES version b Information O...

Страница 17: ...l sent by MECTRON was controlled at the time of dispatch The appliance is shipped appropriately protected and packaged Upon receipt of the appliance check for any possible damage caused during transpo...

Страница 18: ...ooth Treatments without water spray can only be those performed with the Dry Work inserts without water passage CAUTION In treatments requiring irrigation use only inserts with a liquid passage WARNIN...

Страница 19: ...efficiency Diamond Inserts diamond inserts must be replaced when the layer of titanium nitride is visibly worn and in any case after a maximum of 10 treatments When the nitriding is consumed the cutt...

Страница 20: ...e handpiece with the groove on the connector of the cord Check that the electrical contacts of both are perfectly dry and if necessary dry them by blowing with compressed air 1 Screw in the preselecte...

Страница 21: ...provided by the manufacturer of the dental unit 5 If the treatment with spray is required activate the Water function in accordance with the instructions provided by the manufacturer of the dental uni...

Страница 22: ...only original Mectron inserts Do not change in any way the shape of the insert by bending it or filing it This could cause it to break Do not use an insert that has undergone deformation of any type D...

Страница 23: ...and the broken file to stop it from being pushed further it Do not apply pressure on the insert in an axial direction 5 DISASSEMBLING PARTS FOR CLEANING AND STERILISATION Before carrying out the clea...

Страница 24: ...18 COMPACT PIEZO P2K CAUTION Do not try to unscrew or turn the connector when disconnecting the handpiece The connector can be damaged 3 Unscrew the nose cone from the handpiece 4...

Страница 25: ...hapter 6 3 on page 28 and then sterilisation Chapter 6 4 on page 29 one of the two possible cleaning methods explained in detail in the following chapters must be selected CAUTION The instructions sup...

Страница 26: ...ms all liability for any damage caused by the substances mentioned above In case of damage caused by those substances the Warranty will be void Prepare a solution of enzymatic detergenta with pH 6 9 a...

Страница 27: ...r handpiece titanium shaft 3 external and internal parts of nose cone Rinse thoroughly with running water to remove any detergent residue and perform the last rinse with demineralised water 4 Process...

Страница 28: ...the insert using the brush with soft nylon bristles to eliminate all traces of visible dirt Thoroughly clean the difficult areas such as the cutting edges 7 Delicately brush the surface of the insert...

Страница 29: ...ds to eliminate all detergent residue 10 Place the insert in the ultrasonic tank immersed in the enzymatic detergent solution at 40 C 2 C for at least 10 minutes 11 Remove the insert from the ultrasou...

Страница 30: ...for 10 minutes at ambient temperature 22 C 2 C This procedure reduces the amount of blood protein and mucus on the instrument s 15 While soaking in the enzymatic solution gently brush all the surface...

Страница 31: ...l surfaces of the wrench with a clean brush with soft nylon bristles under running water 19 6 1 2 Automatic Cleaning Automatic cleaning can be carried out as an alternative to the manual cleaning desc...

Страница 32: ...onal to the scaler handpiece connector and then to the water jet cleaning connections of the thermal disinfector Repeat the same operation for the inserts by connecting them to the appropriate adapter...

Страница 33: ...ht if necessary using a magnifying glass 2 5X paying attention to any parts that may conceal soil residue threading cavities grooves and if need be repeat the cleaning cycle if soil is still visible F...

Страница 34: ...t the start and end of the sterilisation cycle before the cord is connected to the appliance Always make sure that the electrical contacts of the connector are perfectly dry if necessary dry them blow...

Страница 35: ...the inserts tightening wrench with medical grade lubricants in the indicated point CAUTION Do not use oil or silicone based lubricants 4 6 4 Sterilisation 6 4 1 Preparation Seal the scaler handpiece...

Страница 36: ...m guarantees a SAL 10 6 by setting the parameters indicated below Type of cycle 3 times Pre vacuum pressure min 60 mBar Minimum sterilisation temperature 132 C interval 0 C 3 C Minimum sterilisation t...

Страница 37: ...e dental unit to have it replaced 8 METHODS AND PRECAUTIONS FOR DISPOSAL WARNING Hospital waste Treat the following objects as hospital waste Inserts when worn or broken Inserts tightening wrench when...

Страница 38: ...Supply Power adapter compliant with IEC EN 60601 1 24 V 50 60 Hz or 32 V Max Power Consumption 40 VA Working Frequency Automatic Scan From 24 KHz to 36 KHz Power Adjustable in accordance with the ind...

Страница 39: ...cables and accessories not supplied by MECTRON may adversely affect the EMC performances 9 1 1 Guide and Manufacturer s Declaration Electromagnetic Emissions COMPACT PIEZO P2K is designed to operate i...

Страница 40: ...hysiological signal simulation and COMPACT PIEZO P2K must be positioned within a 0 1 m radius of the vertical plane of the uniform field area in the same direction as COMPACT PIEZO P2K b COMPACT PIEZO...

Страница 41: ...ronment Pulses common mode a b j k o IEC 61000 4 5 0 5 kV 1 kV 2kV The quality of the network voltage should be that of a typical commercial or hospital environment Conductive disturbances induced by...

Страница 42: ...neously j Devices and systems that do not have a surge protection device in the primary power circuit can only be tested at 2 kV between the line s and the ground common mode and at 1 kV between line...

Страница 43: ...uitable an EM clamp must be used In any case no intentional decoupling device should be used between the injection site and POINT OF CONNECTION TO THE PATIENT The tests can be performed with other mod...

Страница 44: ...al cables b SIP SOPS with maximum cable length less than 3 m are excluded c The tests can be performed with other modulation frequencies identified by the RISK MANAGEMENT PROCESS d The calibration of...

Страница 45: ...80 390 TETRA 400 Pulse modulation b 18 Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM c 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE band 13 17 Pulse modulation b 217 Hz 0 2 0 3 9 745 780 810 80...

Страница 46: ...working APC automatic protection circuit tripped The insert is not present or not correctly tightened on the handpiece Unscrew and correctly re screw the insert The insert is worn damaged or deformed...

Страница 47: ...the handpiece and release the water passage of the insert by blowing compressed air through it If the problem persists replace the insert with a new one The handpiece is clogged Contact an Authorised...

Страница 48: ...fuse goods that arrive in unsuitable conditions returning them at the client s own expense for proper cleaning and sterilisation The appliance must be returned suitably packaged and accompanied by all...

Страница 49: ...ied out by personnel not authorised by Mectron The environmental conditions for preservation and storage of the device do not comply with the requirements indicated in Chapter 6 on page 19 Use of non...

Страница 50: ...ir own expense to the MECTRON dealer importer from which they purchased the product The appliance must be returned together with the original packaging accompanied by all the accessories and by a form...

Страница 51: ......

Страница 52: ...150175 Rev 07 31 05 2021 Manufacturer Mectron S p A Via Loreto 15 A 16042 Carasco Ge Italy Tel 39 0185 35361 Fax 39 0185 351374 www mectron com e mail mectron mectron com Rivenditore Reseller Revendeu...

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