mectron PIEZOSURGERY plus User manual
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
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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.
II
TABLE OF CONTENTS
1 Introduction 1
1.1 Intended Use of PIEZOSURGERY® plus 1
1.2 Description of the Device 2
1.2.1 Users 2
1.3 Disclaimer 2
1.4 Safety Requirements 3
1.5 Symbols 5
2 IdenticationData 7
3 Delivery 9
4 InstallationandConguration 10
4.1 Safety Requirements During Installation 10
4.2 Device Installation 11
4.3 Switching On the Device 13
4.13 Foot Pedal Button 25
4.14 Safety Requirements Before and During Use 26
5 Maintenance 31
6 DisposalMethodandPrecautions 31
7 TechnicalData 31
8 Troubleshooting 41
III
9 Packaging 49
10 Warranty 50
IV
PAGEINTENTIONALLYLEFTBLANK
1
1 INTRODUCTION
1 manuals.mectron.com
with installation operations, use, maintenance
or other intervention operations on the device.
IMPORTANT: to avoid potential serious
this device or other equipments, read all the
“Safety precautions” present in the manual
with particular attention.
WARNING, CAUTION and NOTE
contained in this document, carry special
meaning and must be carefully reviewed.
Depending on their degree of seriousness, the
WARNING:
CAUTION:
practices that could result in minor injury or
NOTE:
that operators are aware of the safety
requirements, installation procedures, and
instructions for correct use and maintenance
of the device and its accessories. Using this
manual for purposes other than those relating
to the installation, use and maintenance of the
and illustrations contained in this manual are
on the last page.
updating of our products, which may entail
changes to components of the device.
In case you encounter discrepancies between
the descriptions found in this manual and the
equipment in your possession you can:
•
the
website
1
;
•
Service.
1.1 IntendedUseofPIEZOSURGERY®plus
PIEZOSURGERY® plus is an ultrasonic
surgical system consisting of handpieces and
associated tips for osteotomy, osteoplasty
and drilling in a variety of surgical procedures
including but not limited to:
• Otolaryngology surgery;
• ;
• Hand and foot surgery;
• Neurosurgery;
• Spinal surgery;
• ;
• Orthopaedic surgery;
• .
visual assistance to perform the above listed
procedures.
WARNING: Only use the device for its
intended use. Failure to comply with this
requirement may lead to serious injury to the
the device.
WARNING
recommendations given in this manual to
Failure to do so may lead to serious injury to
WARNING
the operating theatre of a hospital.
2
WARNING: Qualiedandspecialised
personnel.
specialised personnel such as a surgeon with
proper medical culture; no training activities
are foreseen for the use of the device. If
correctly used, this device causes no side
transmit heat to the tissues.
WARNING: Riskofexplosion.
there is an atmosphere saturated with
WARNING: PIEZOSURGERY® plus is not
suitable for direct cardiac application.
1.2 DescriptionoftheDevice
device uses
generate mechanical micro vibrations that can
cut through mineralised structures causing
minimal damage to soft tissues.
has two
types and with independent electronics.
®
medical handpiece to be used, to which the
®medical
inserts can be connected.
®
®
inserts can be connected.
WARNING: All handpieces can be used in
especially recommended in the case of highly
mineralised bone.
immediately available; they are activated by
the graphic interface to select the chosen
insert and set the power type and irrigation
manufacturer Mectron.
WARNING
from overheating, we recommend increasing
irrigation levels as power type increases.
1.2.1 Users
U.S. Federal law restricts this device to sale by or on the order of a licensed physician.
1.3 Disclaimer
objects occurring following incorrect procedures connected with the use of the device and its
accessories.
1. Use in procedures other than those
2.
comply with the requirements indicated
in the
31
;
3.
with the instructions and requirements
described in this manual;
4.
the device is used do not comply with
the applicable standards and relevant
requirements;
5.
update or repair has been carried
out by personnel not authorised
3
personnel only;
CAUTION
6.
interventions;
All attempted tampering or changes to
the device in any circumstances;
damages the handpiece thread,
injury to the patient;
Mectron inserts, used according to the
settings designed and tested on original
use of settings is only guaranteed with
10.
event of failure or problem.
1.4 SafetyRequirements
WARNING: MR-UNSAFE
WARNING: Riskofexplosion.
where the atmosphere is saturated with
WARNING: Contraindications.
Interferencewithotherequipment.
Although PIEZOSURGERY® plus complies
with other equipment located nearby.
PIEZOSURGERY® plus must not be used
PIEZOSURGERY® plus at a safe distance
and monitor that the device and all other
equipment function correctly in that layout.
WARNING: Contraindications.
Interferencebyotherequipment. An
devices near the PIEZOSURGERY® plus
device, may interfere with its correct
functioning.
CAUTION: If the end user should need
to submit the equipment in its facility to
relevant requirements, the test procedures
to be applied to electromedical systems and
devices to evaluate safety must be carried
out by means of standard EN 62353 “Medical
after repair of medical electrical equipment”.
intended operating conditions and described
in this “Use and Maintenance” manual, is one
year.
WARNING: Checktheconditionof
thedevicebeforetreatment.
device status before the treatment. Always
the device. Before every treatment, always
use the device and its accessories if damage
abnormalities concern the device.
CAUTION
room in which the device is installed and
used must comply with applicable standards
and relevant electrical safety requirements.
CAUTION
this device must only be connected to power
grids with protective earth.
4
WARNING
pump cover is open, the foot pedal of
PIEZOSURGERY® plus must not be pressed.
Moving parts may injure the operator.
WARNING: Personalinjury.
to ensure that cables do not hinder the free
movement of personnel.
CAUTION
by or on the order of a physician.
WARNING
damages are found, do not use.
WARNING: Do not activate the device if
Replace the handpiece immediately.
WARNING: Only use original
parts.
CAUTION: No changes can be made to
this device.
WARNING
must not attempt to remove it or tamper with
it as this would invalidate the warranty and
may damage the device.
WARNING: Contraindications. Do not
use the PIEZOSURGERY® plus on patients
operator.
CAUTION: Contraindications. Do not
carry out this treatment on metal or ceramic
could cause them to decement.
WARNING:Infectioncontrol.
safety, before using all reusable parts and
accessories, please ensure that they have
been previously cleaned and sterilised in
accordance with the instructions given in the
WARNING: Cleaningandsterilisation
ofneworrepairedtools. All new and
repaired reusable device accessories are
after each treatment, they must be cleaned
and sterilised in strict compliance with
Sterilisation Manual.
CAUTION: Contraindications. After
having sterilised the handpiece, the torque
wrench or all other sterilisable accessories in
the autoclave, wait for them to have cooled
completely before reusing.
WARNING: Breakageandwearofthe
inserts.
general wear and tear can, very occasionally,
the shape or sharpen an insert in any way.
Bending an insert or applying leverage to it
comes into contact with metal objects, it may
fragments remain in the treated part, and at
any. If a fragment cannot be found, use
regular occasions during the intervention,
and particularly the apical part. During the
intervention, avoid prolonged contact with
retractors or other metal tools being used.
5
1.5 Symbols
Symbol Description Symbol Description
0051
Device compliant
Medical Device
Instructions For Use
Operating Instructions Manufacturer
Date of manufacture Serial Number
Product Number
autoclave up to a
recommendation
pedal
I Activation switch “on” 0
Functional earth
accessories must not be
disposed of or treated
as solid urban wastes
6
Symbol Description Symbol Description
General warning Do not touch moving
parts
for transport and
storage
Humidity limitation for
transport and storage
Atmospheric pressure
limitation for transport
and storage
damaged
Graphic symbol
intended to identify
used to connect the
PIEZOSURGERY®
medical handpiece.
Graphic symbol
intended to identify
used to connect the
PIEZOSURGERY®
International Protection
protection.
IP20
International Protection
casing.
CAUTION:
U.S. Federal
law restricts this device
to sale by or on the
order of a licensed
physician
be used in a Magnetic
environment
Table1 – Symbols
2 IDENTIFICATIONDATA
A precise description of the model and device
Always provide this information when
2.1 DeviceIdenticationLabel
label showing its main technical
31
.
manufacturer
Mectron S.p.A.
Via Loreto 15/A
16042 Carasco -GE- Italy
420000000
PIEZOSURGERY plus
100-240 V~250 VA - 50/60 Hz.
Rx Only
0051
04000102 YYYY-MM-DD
made in Italy
HIBC 128 Bar Code
and the A separate label shows further
symbols and characteristics of the device.
the device.
NOTE:
their description are shown in
1.5 on page 5
.
Device for intermittent operation:
50 s ON - 60 s OFF with irrigation
PIEZOSURGERY plus
2.2 HandpieceIdenticationData
Figure 1 at page
•
•
• its date of manufacturing;
• the device name (PIEZOSURGERY®
• the Mectron logo;
•
•
symbols.
NOTE:
description are shown in
5.
PIEZOSURGERY®
medical
PIEZOSURGERY®
medical +
HIBC 128
Data Matrix
HIBC 128
Data Matrix
YYYY-MM
421000000
03120243
0051
medical +
medical
408000000
03120127
0051
YYYY-MM
Figure1 –
2.3 InsertsIdenticationData
following data:
•
•
• the batch number to which the
•
Read the Instructions For Use”
MT1-10
A A/XXXXX
1 2 3 4
•
• the batch number to which the
•
cover and the matching insert name
5
6
7
3 DELIVERY
3.1 ListoftheComponentsintheStandardKit
Refer to the front endpaper.
PIEZOSURGERY® plus is provided with the following components:
A. Device core system;
B. 2 Peristaltic Pumps;
2 Stands for Solution Bag;
D.
E.
F.
connector;
G.
3.2 ListoftheAccessories
PIEZOSURGERY® plus can be equipped with accessories available separately:
H. Handpiece:
•
supplied with the cord and the
connector protective cap,
• PIEZOSURGERY®medical , supplied
with the cord and the connector
protective cap,
CAUTION
cannot be separated.
I.
•
•
• PIEZOSURGERY® medical,
J.
•
• PIEZOSURGERY® medical,
WARNING
inserts can only be assembled onto
PIEZOSURGERY® medical inserts can only be
assembled onto PIEZOSURGERY® medical
handpieces.
PIEZOSURGERY® medical single use
strong impacts as contains electronic
components, therefore the transport and the
storage must be carried out with particular
care.
controlled at the time of dispatch.
possible damage caused during transport and
complain to the transporter.
Service and to store the device during long
periods of inactivity.
10
4 INSTALLATIONANDCONFIGURATION
it must be installed by an authorised
be installed in a suitable and convenient place
for its use.
following 6 steps:
1.
2.
installation;
3.
4.
maintain the system;
5. Fill in the installation and hospital
personnel training forms;
6.
forms to guarantee traceability of
the device and the activation of the
warranty.
4.1 SafetyRequirementsDuringInstallation
WARNING: MR-UNSAFE
WARNING: Contraindications.
Interferencewithotherequipment.
Although PIEZOSURGERY® plus complies
with other equipment located nearby.
PIEZOSURGERY® plus must not be used
PIEZOSURGERY® plus at a safe distance
and monitor that the device and all other
equipment function correctly in that layout.
WARNING: Contraindications.
Interferencebyotherequipment. An
devices near the PIEZOSURGERY® plus
device, may interfere with its correct
functioning.
WARNING: Riskofexplosion.
device cannot function in places where there
CAUTION
room in which the device is installed and
used must comply with applicable standards
and relevant electrical safety requirements.
CAUTION
this device must only be connected to power
grids with protective earth.
CAUTION
direct sunlight or sources of UV light.
WARNING:
pump cover is open, the foot pedal of the
PIEZOSURGERY® plus must not be pressed.
Moving parts may injure the operator.
WARNING: Install the device in a place
where it will be protected from blows and
accidental sprays of water or other liquids.
WARNING: Do not install the device on,
such a way as to ensure adequate circulation
space around it, in particular with reference
CAUTION
however it must be handled with care when
in such a way that it can only be activated
intentionally by the operator.
CAUTION: Position the device in such
a way as to ensure that the plug is easily
accessible as this is considered a means for
disconnecting the power supply.
11
CAUTION: Before connecting the
electrical contacts are perfectly dry. Dry with
compressed air if necessary.
CAUTION: Do not allow the machine
body or foot pedal to become wet. If liquid
should enter the machine body or foot pedal,
this may cause damage.
CAUTION: No changes can be made to
this device.
4.2 DeviceInstallation
Equipotential plug: there is an additional
the additional equipotential connection
that may occur during operation between
the device body and the conductive
parts of other objects within the medical
environment;
1
Insert the power supply cord into its
CAUTION: Position the device in
such a way as to ensure that the plug
is easily accessible as this is considered
a means for disconnecting the power
supply.
2
the symbol , using the foot pedal
machine body, grasp the connector, crush
NOTE: if the foot pedal ceases
of the device, below the symbol , can
be used to continue treatment.
3
12
NOTE: the foot pedal is provided with
enables it to be moved to the most
appropriate place for use, with no need
to touch it with hands.
4
Insert the 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
two parts match;
6
Pull the pump gently to ensure that it is
correctly positioned.
7
CLICK!
13
4.3 SwitchingOntheDevice
Switch the device on by means of the
pedal down during this stage.
1
on
off
4.4 LanguageSelection
CAUTION:
only if no handpieces are connected to the
device.
Switch the device on without any
handpieces connected.
following screen appears.
the English is the default language.
language button;
1
All the available languages will appear.
desired language.
2
14
;3
Now, the handpieces can be connected
NOTE: to change the language during
use, disconnect the handpieces and
4
4.5 IrrigationKitInstallation
handpiece by using the clips supplied;
1
Open completely the peristaltic pump
cover;
Insert the part of the irrigation tube with
the largest diameter and measuring 15
cm in length, into the peristaltic pump;
completely;
2
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