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5

INTRODuCTION

1.5 

Symbols

Symbol

Description

Symbol

Description

0051

Device compliant 

with  Regulation  (Eu) 

2017/745. 

Notified 

body: IMQ S.p.A.

Nemko Mark

uL CSA compliance

Medical Device

Caution, read the 

Instructions For Use

Operating Instructions

Manufacturer

Date of manufacture

Serial Number

Lot Number

Product Number

Single-use

Do not resterilize

use-by date

Sterilized with Ethylene 

Oxide (EO)

Non-sterile

Can be sterilized in 

autoclave up to a 

maximum temperature 

of 135° C

Type “B” applied part 

as per EN 60601-1 

recommendation

Equi-potentiality

Alternating Current

Connection of the foot 

pedal

I

Activation switch “on”

0

Activation switch “off”

Functional earth

Caution, risk of electric 

shock

Biohazard

The device and its 

accessories must not be 

disposed of or treated 

as solid urban wastes

Содержание PIEZOSURGERY plus

Страница 1: ...Rx Only CAUTION U S Federal law restricts this device to sale by or on the order of a licensed physician USE AND MAINTENANCE MANUAL 0051...

Страница 2: ...A D E B F C x2 x2 G H I J K...

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

Страница 4: ...cription 20 4 11 Device Configuration 23 4 12 Modify the Device Configuration 24 4 13 Foot Pedal Button 25 4 14 Safety Requirements Before and During Use 26 4 15 Important Information on Inserts 29 4...

Страница 5: ...III 9 Packaging 49 10 Warranty 50...

Страница 6: ...IV PAGE INTENTIONALLY LEFT BLANK...

Страница 7: ...The information and illustrations contained in this manual are updated as of the date of publication specified on the last page MECTRON is committed to the continuous updating of our products which ma...

Страница 8: ...y are activated by simply pressing the finger against the screen at the chosen buttons The user can use the graphic interface to select the chosen insert and set the power type and irrigation values w...

Страница 9: ...RY plus at a safe distance from life support equipment If necessary however prior their use please check and monitor that the device and all other equipment function correctly in that layout WARNING C...

Страница 10: ...cleaned and sterilised in accordance with the instructions given in the Cleaning and Sterilisation Manual WARNING Cleaning and sterilisation of new or repaired tools All new and repaired reusable dev...

Страница 11: ...t Number Product Number Single Use Do not resterilize Use by date Sterilized with Ethylene Oxide EO Non sterile Can be sterilized in autoclave up to a maximum temperature of 135 C Type B applied part...

Страница 12: ...2 used to connect the PIEZOSURGERY medical handpiece IPX8 International Protection Code of the mechanical casing Liquid ingress protection IP20 International Protection Code of the mechanical casing Q...

Страница 13: ...60 Hz Rx Only 0051 04000102 YYYY MM DD made in Italy HIBC 128 Bar Code Each device has its own identification label showing its main technical specifications and the A separate label shows further sym...

Страница 14: ...following data the insert model name Ref 1 the Mectron logo Ref 2 the batch number to which the insert belongs Ref 3 the Single use and CAUTION Read the Instructions For Use symbols Ref 4 MT1 10 A A X...

Страница 15: ...edical J Single use Inserts PIEZOSURGERY medical PIEZOSURGERY medical WARNING PIEZOSURGERY medical inserts can only be assembled onto PIEZOSURGERY medical handpieces PIEZOSURGERY medical inserts can o...

Страница 16: ...uipment An electrosurgical knife of other electrosurgical devices near the PIEZOSURGERY plus device may interfere with its correct functioning WARNING Risk of explosion The device cannot function in p...

Страница 17: ...tial connection is to reduce the difference in potential that may occur during operation between the device body and the conductive parts of other objects within the medical environment 1 Insert the p...

Страница 18: ...solution bag stand into the proper holes 5 Install the two peristaltic pumps gently pushing the head of the peristaltic pump towards the corresponding base on the device Carefully rotate the pump head...

Страница 19: ...an be selected only if no handpieces are connected to the device Switch the device on without any handpieces connected After the initial system check the following screen appears The first time the de...

Страница 20: ...allation Open the previously sterilised handpiece packaging and the irrigation kit removing the tubing and the fixing clips Connect the end of the irrigation tube to the specific attachment on the han...

Страница 21: ...SURGERY medical handpiece that can be equipped with the sterile single use PIEZOSURGERY medical inserts Channel 2 CH2 allows the connection of the PIEZOSURGERY medical handpiece that can be equipped w...

Страница 22: ...ing it by the connector only Never pull the cord To disconnect the connector of the cord handpiece from channel 2 CH2 instead proceed as follow The cord handpiece connector for channel 2 CH2 is equipp...

Страница 23: ...in an anticlockwise direction 1 Screw the extension supplied in the kit into the PIEZOSURGERY medical handpiece till the end of the threading 2 Tighten the extension using the PIEZOSURGERY medical L t...

Страница 24: ...t of the wrench slips compared to the handpiece producing mechanical a clicking sounds CLICK The extension is now properly tightened 5 click Screw the cover supplied in the kit into the PIEZOSURGERY m...

Страница 25: ...the handpiece WARNING PIEZOSURGERY medical inserts can only be installed onto PIEZOSURGERY medical handpieces PIEZOSURGERY medical inserts can only be installed onto PIEZOSURGERY medical handpieces 1...

Страница 26: ...ton or icon on the screen CAUTION Do not use any sharp or pointed objects on the touchscreen the display or the touch screen may be damaged The simple finger pressure even wearing latex gloves allows...

Страница 27: ...inserts belonging to a specific family They are listed according to increasing numbering with up to 8 shown per page PAGE LAYOUT BUTTONS When there are more than 8 inserts the page layout buttons all...

Страница 28: ...identify the status of the associated function The colors and states are described below WHITE Indicates that the button is not selected Function not active LIGHT BLUE Indicates that the button is pre...

Страница 29: ...d insert 2 For each insert the system automatically set the optimal working settings By using the and buttons the irrigation and power levels can be changed within the range defined by the manufacture...

Страница 30: ...rating the configuration options are disabled CHANGING THE SETTINGS To change the IRRIGATION and POWER settings press the and buttons Proceed with the step 5 described in Chapter 4 11 on page 23 To de...

Страница 31: ...CHANGING THE WORKING CHANNEL To change the working channel press the relevant handpiece button The screen of the new handpiece will appear To activate the channel repeat the steps from 2 to 8 describ...

Страница 32: ...nt If experiencing problems with the device contact Piezosurgery Inc Service WARNING Infection control First use all reusable parts and accessories whether new or returned from Piezosurgery Inc Servic...

Страница 33: ...he PIEZOSURGERY medical handpiece is correctly connected before using the system WARNING Before each treatment assure that the insert suitable for the treatment has been mounted on the handpiece Only...

Страница 34: ...r metal tools being used WARNING The PIEZOSURGERY plus device is intended for bone surgery However prolonged contact and or excessive force of the instrument tip on soft tissues should be avoided as t...

Страница 35: ...ice settings are only tested and guaranteed for correct function with original PIEZOSURGERY medical inserts For information on how to correctly use the inserts consult the accompanying Instructions fo...

Страница 36: ...rmation window will appear Press the confirmation button to proceed with the shut down or the cancel button to return to the working screen 2 Switching off the device When switching off message appear...

Страница 37: ...that imply a biological risk must be disposed of in accordance with current local regulations governing hospital waste PIEZOSURGERY plus must be disposed of and treated as a waste requiring separate...

Страница 38: ...e preset by Mectron APC circuit protections No handpiece detected Cord interruption Insert not tightened correctly or broken Malfunction detection system The system displays an anomaly detected and th...

Страница 39: ...ation WARNING The device requires specific EMC precautions and must be installed and commissioned according to the EMC information provided in this chapter WARNING Only use original Piezosurgery Mectr...

Страница 40: ...This device is intended for use by healthcare professionals only The EMISSIONS characteristics of the PIEZOSURGERY plus make it suitable for use in industrial areas and hospitals CISPR 11 class A If...

Страница 41: ...ogical signal simulation if used and the PIEZOSURGERY plus shall be located within 0 1 m of the vertical plane of the uniform field area in one orientation of the PIEZOSURGERY plus b PIEZOSURGERY plus...

Страница 42: ...induced by RF fields c d o IEC 61000 4 6 3 V m 0 15 MHz 80 MHz 6 V m in the ISM bands between 0 15 MHz and 80 MHz n 80 AM at 1 KHz e Portable and mobile RF communication devices should not be used nea...

Страница 43: ...ne s k Not applicable to CLASS II PIEZOSURGERY plus l Direct coupling shall be used m r m s before modulation is applied n The ISM industrial scientific and medical bands between 0 15 MHz and 80 MHz a...

Страница 44: ...lamp is not suitable an EM clamp shall be used No intentional decoupling device shall be used between the injection point and the PATIENT COUPLING POINT in any case Testing may be performed at other m...

Страница 45: ...tput lines intended to connect directly to outdoor cables b SIP SOPS whose maximum cable length is less than 3 m in length are excluded c Testing may be performed at other modulation frequencies ident...

Страница 46: ...TRA 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 9 745 780 810 800 960 GSM...

Страница 47: ...ssages and Solutions The PIEZOSURGERY plus is provided with a diagnostic circuit that detects any operating anomalies and display them on the touch screen by using the MED XXX notation There are three...

Страница 48: ...MED 005 Tighten the insert tip If the problem persists replace the handpiece 1 Tighten the insert Insert not properly fastened onto the handpiece 2 If the problem persists replace the handpiece Drop...

Страница 49: ...ly the Piezosurgery Inc s Service Centre Failure in the execution of the module interface program MED 030 Internal problem please contact assistance The device is working properly contact the Piezosur...

Страница 50: ...e device then start it again SHUTDOWN the device and then start it again If the problem persists contact the Piezosurgery Inc s Service Centre Data synchronization needed MED 050 a MED 058 Internal pr...

Страница 51: ...evice socket Correctly insert the foot pedal plug into the socket on the back of the device The foot pedal is not functioning correctly If this occurs during operation disconnect the foot pedal from t...

Страница 52: ...not correctly installed Check the irrigation kit connections The device is working properly but the pump works with difficulty Excessive pressure of the peristaltic pump impeller on the tube Check th...

Страница 53: ...disconnect it from the electrical power socket before proceeding Use a small flat head screwdriver to carefully pry off the fuse tray located above the mains socket 1 Remove the fuse tray WARNING Repl...

Страница 54: ...n authorization number that a quote is required If a quote is not requested the repair will be processed and your account billed accordingly provided the repair is not covered under warranty 8 4 2 Ret...

Страница 55: ...ackaging 9 PACKAGING Pack the device as shown in the following figure To unpack reverse all steps below CAUTION Remove all the accessories before removing the device core system A B C D 1 2 3 4 5 A B...

Страница 56: ...8 Returns must be authorized by PIEZOSURGERY Inc PIEZOSURGERY Inc cannot accept responsibility for returns which have not been authorized ContactPIEZOSURGERY Inc CustomerService at 1 888 87 PIEZO for...

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Страница 60: ...o 15 A 16042 Carasco Ge Italy Tel 39 0185 35361 Fax 39 0185 351374 www mectron com e mail mectron mectron com Reseller Rivenditore Wiederverk ufer Revendeur Revendedor Distributed in U S by 850 Michig...

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