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mectron PIEZOSURGERY GP, Use And Maintenance Manual

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USE AND MAINTENANCE MANUAL

Rx Only - CA

UTION: 

 

U.S. 

Federal 

law restricts 

this device to 

sale by 

or on the order of a licensed dentist.

0051

Summary of Contents for PIEZOSURGERY GP

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

Page 2: ...E A K H G B J F C I O M A D L N NOT SUPPLIED...

Page 3: ...Piezosurgery GP is manufactured and sold internationally by Mectron S p A under the name Piezosurgery white P Q R S...

Page 4: ......

Page 5: ...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...

Page 6: ...ntenance 24 7 Disposal Method and Precautions 24 8 Technical Specifications 25 8 1 Electromagnetic Compatibility IEC EN 60601 1 2 26 8 1 1 Guidance and Manufacturer s Declaration Electromagnetic Emiss...

Page 7: ...III PAGE INTENTIONALLY LEFT BLANK...

Page 8: ...IV PAGE INTENTIONALLY LEFT BLANK...

Page 9: ...this manual are updated as of the date of publication specified on the last page The manufacturer MECTRON S p A is committed to the continuous updating of its products which may entail changes to comp...

Page 10: ...device to sale by or on the order of a licensed dentist 1 3 Disclaimer The manufacturer Mectron and the distributor Piezosurgery Inc disclaim any liability expressed or implied and shall have no respo...

Page 11: ...anual is one year WARNING Checking device status before the treatment Always check that there is no water underneath the device Before every treatment always check that the device works perfectly and...

Page 12: ...for single use only WARNING Only use original Piezosurgery Mectron inserts accessories and spare parts WARNING Contraindications Do not use the PIEZOSURGERY GP on patients who carry heart stimulators...

Page 13: ...t Number Product Number Single Use Do not re sterilize 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...

Page 14: ...d IP22 International Protection Code of the mechanical casing IP20 International Protection Code of the mechanical casing QTY 1 Quantity of items in the package 1 Rx Only For US market only CAUTION U...

Page 15: ...GERY white 100 240 V 120 VA 50 60 Hz Rx Only 0051 00000000 YYYY MM DD made in Italy HIBC 128 Bar Code A separate label shows further symbols and characteristics of the device This identification label...

Page 16: ...51 YYYY MM white Figure 1 Handpiece Identification Data 2 3 Inserts Identification Data The following data are laser marked on each insert the name of the insert Ref 1 the Mectron logo Ref 2 and the l...

Page 17: ...sed for example kits and or dedicated torque wrenches Always read and follow the assembly and cleaning instructions supplied with the insert PIEZOSURGERY GP consists of accessories that can be ordered...

Page 18: ...nt to the norms in force and to the relative electrical safety precautions CAUTION Only connect the console to hospital grade receptacles to ensure electrical grounding reliability This device must be...

Page 19: ...der can be placed in 4 different positions right side front right side front left side and left side 2 Insert the peristaltic pump tubing supplied with the device into the connector of the handpiece c...

Page 20: ...erate the footswitch of the PIEZOSURGERY GP device when the peristaltic pump cover is open Moving parts could injure the operator 6 Connect the peristaltic pump tubing to the flow adjuster not supplie...

Page 21: ...tacle on the back of the console Connect it only to hospital grade receptacles 10 Equipotentialplug Thedeviceisequipped with an additional equipotential plug located on the rear of the console This pl...

Page 22: ...and it is ready to use Switching the Device Off To switch the device off set the switch buttonlocatedontheleftsideofthedevice to position 0 taking care not to press the foot pedal down during this st...

Page 23: ...d to the cutting and removal of highly mineralized bone IMPLANT dedicated to bone perforation in the technique of the implant site preparation FILLING AND FLUSHING THE IRRIGATION CIRCUIT Ref Q front e...

Page 24: ...e irrigation column 7 capacity levels are available 0 no operation of the pump no irrigation outflows from the insert Da 1 a 6 the pump flow ranges from 8 ml min to approximately 75 ml min The irrigat...

Page 25: ...onal PIEZOSURGERY GP is compatible with the PIEZOSURGERY touch handpiece only available as optional By connecting the PIEZOSURGERY touch handpiece the LED light on the front terminal of the handpiece...

Page 26: ...ontact Piezosurgery Inc if the abnormalities concern the device CAUTION FLUSH function After the device is used with aggressive and non aggressive solutions it is necessary to perform a flushing cycle...

Page 27: ...s the user must pay particular attention to avoiding injury from inserts with sharp points and cutting edges WARNING Breakage and wear out of the inserts High frequency oscillations and wear out may i...

Page 28: ...ecting the irrigation kit from the physiological irrigation bag 1 To fill the irrigation circuit use the PUMP function To activate the FLUSH function press and hold the button PUMP FLUSH on the touch...

Page 29: ...e handpiece firmly CAUTION The handpiece must not be grabbed by its terminal part and or cord but only by its central body The handpiece must not be rotated but must be grasped firmly and you must onl...

Page 30: ...urgery Mectron insert NOTE Check the level of physiological solution contained in the irrigation bag Replace the irrigation bag with a new one before it is completely empty 7 After each use of PIEZOSU...

Page 31: ...he warranty damages the threading of the PIEZOSURGERY GP handpiece with the risk of no longer being able to screw the original inserts correctly during subsequent use Moreover the device settings are...

Page 32: ...ition If damaged replace it with an original Piezosurgery Mectron spare part 7 DISPOSAL METHOD AND PRECAUTIONS WARNING Hospital waste Treat the following items as hospital waste Inserts when they are...

Page 33: ...ELLOUS CORTICAL IMPLANT Peristaltic pump capacity Adjustable on the touch screen ENDO PERIO 7 flow levels from 0 to 6 from 0 to approximately 75ml min SPECIAL CANCELLOUS CORTICAL IMPLANT 6 flow levels...

Page 34: ...evice requires specific EMC precautions and must be installed and commissioned according to the EMC information provided in this chapter WARNING Only use original Piezosurgery Mectron accessories and...

Page 35: ...ENT physiological signal simulation if used and the PIEZOSURGERY GP shall be located within 0 1 m of the vertical plane of the uniform field area in one orientation of the PIEZOSURGERY GP b PIEZOSURGE...

Page 36: ...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 ne...

Page 37: ...o line s k Not applicable to CLASS II PIEZOSURGERY GP 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...

Page 38: ...amp 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 mo...

Page 39: ...to output 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...

Page 40: ...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 80...

Page 41: ...c circuit that allows to detect operating abnormalities and to view their type on the keyboard via their relative symbol By using the following chart the user is guided toward the identification and p...

Page 42: ...re turning it on again Abnormalities in the power distribution network excessive electrostatic discharges or internal anomalies Turn the device off and wait 5 seconds before turning it on again If the...

Page 43: ...e socket Correctly insert the foot pedal plug into the socket on the back of the device The foot pedal is not working properly Contact Piezosurgery Inc s Service The device is switched on but not work...

Page 44: ...Open the air inlet on the irrigation set The silicon tubing are incorrectly installed Check the irrigation kit connections The device is working properly but the pump works with difficulty Excessive...

Page 45: ...electrical power socket before proceeding Apply leverage with a flat screwdriver inserting its tip in the seat of the fuse holder drawer located under the power supply socket 1 Pull out the fuse hold...

Page 46: ...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 9 4 2 Ret...

Page 47: ...apter 9 4 on page 38 Returns must be authorized by PIEZOSURGERY Inc PIEZOSURGERY Inc cannot accept responsibility for returns which have not been authorized ContactPIEZOSURGERY Inc CustomerService at...

Page 48: ...Revendeur Revendedor 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 Distributed in U S by 850 Michiga...

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