mectron Piezosurgery flex 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
flex
0051
L M
P
O
N
A
BH
I
C
G
F
D
E
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.
II
flex
TABLE OF CONTENTS
1 Introduction 1
1.2 Description of the Device 2
1.2.1 Users 2
1.3 Disclaimer 2
1.4 Safety Precautions 3
1.5 Symbols 5
2 IdenticationData 7
3 Delivery 9
4 FirstInstallation 10
4.1 Safety Requirements in the Installation Phase 10
5 Use 15
5.2 Description of the Keyboard 16
5.5 Instructions for Use 21
5.6 Important Information on Inserts 24
6 Maintenance 25
7 DisposalMethodandPrecautions 25
8 TechnicalSpecications 26
9 Troubleshooting 34
10 Warranty 40
III
PAGEINTENTIONALLYLEFTBLANK
IV
flex
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:
or emphasize important instructions.
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®ex
surgical system consisting of handpieces
and associated insert tips for cutting bone,
osteotomy, osteoplasty and drilling in a
variety of surgical procedures, including but
not limited to:
• Hand and foot surgery;
• surgery;
• Otolaryngology surgery;
•
• Neurosurgery;
• Spine surgery.
visual 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
WARNING:
and follow its recommendations in order
or the user safety. Failure to meet these
requirements may cause serious injuries to
WARNING: Qualiedandspecialized
personnel.
improper use might cause tissues heating.
2
flex
WARNING:
a hospital environment, such as an operating
theatre.
WARNING: Riskofexplosion.
there is an atmosphere saturated with
1.2 DescriptionoftheDevice
piezoelectric ultrasonic bone cutting
instrument: the device uses piezoelectric
ultrasonic technology to generate mechanical
mineralized structures with minimal trauma to
soft tissues.
readily available by integrating them in the
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
and the distributor, Piezosurgery Inc.
or implied, and shall have no responsibility for any direct, indirect or other damages and
personal injury arising out in connection with any improper practice in the use of the device and
and the distributor, Piezosurgery Inc. shall be under
the product and its accessories, as result of:
1.
product;
2.
preservation and storage of the device
are not compliant with the precautions
indicated in the
26;
3.
with all the instructions and precautions
described in this manual;
4.
operating room is not compliant with
the applicable regulations and with
electrical safety requirements;
5.
adjustments, updates, and repairs on
the device are performed by personnel
not authorized by Piezosurgery Inc.;
6.
incorrect interventions;
Any and all attempts to tamper with
or modify the device, under any
circumstance;
Mectron inserts that damage the
threading of the handpiece, thus
compromising correct operation and
Mectron inserts, even if they are used
in accordance to designed and tested
settings is guaranteed only with original
10.
event of device stop due to fault or of
inconveniences.
3
1.4 SafetyPrecautions
WARNING: Riskofexplosion.
where the atmosphere is saturated with
WARNING: Contraindications.
Interferencewithotherequipment.
it may interfere with other devices in its
steps are necessary to eliminate or
reduce the source of interference. Install
device is necessary, normal operation of the
WARNING: Contraindications.
Interferencebyotherequipment. An
may interfere with its correct operation.
CAUTION: In the case the hospital must
and systems to periodical inspections in
order to adhere to imposed requirements
in its own structure, the test procedures
equipment and systems to evaluate safety
must be performed in line with norm EN
inspections and tests to be performed after
in the intended operating conditions and
described in this “Use and Maintenance”
manual, is one year.
WARNING: Checkingdevicestatus
beforethetreatment.
that there is no water underneath the
sure that the device and accessories are in
is noted during operation, do not carry out
the treatment. If the problem concerns the
Service.
WARNING
to which the device is connected must
comply with all the applicable standards and
with electrical safety requirements.
WARNING
this device must be grounded. Only connect
the console to hospital grade receptacle to
ensure electrical grounding reliability.
WARNING: Do not operate the foot
the peristaltic pump cover is open. Moving
Personal injuries may result.
WARNING: Personalinjury.
that power cables do not interfere with free
circulation of people in the area.
CAUTION
the order of a physician.
WARNING: Prior to any use, system
components should be inspected for
damage. Do not use if damage is apparent.
WARNING: Do not operate the device
if the handpiece is defective, damaged or
WARNING: Only use original
and spare parts.
CAUTION
equipment is allowed.
4
flex
WARNING: Contraindications. Do
precaution also applies to the operator.
CAUTION: Contraindications. Do not
carry out any treatments on metal or ceramic
could cause decementation of such artifacts.
WARNING:Single-useaccessories.
individual patient during a single surgical
procedure and then discarded.Do not
use items.
WARNING: Controlofinfections-
ReusableAccessories
First Use
and sterilized prior to use by applying the
Sterilization manual provided with the device.
EveryuseOnce used, each reusable
accessory must be thoroughly reprocessed
prior to reuse, according to the procedures
manual provided with the device.
CAUTION: Allow reusable, autoclavable
accessories to gradually return to room
temperature after steam sterilization and
be accelerated.
WARNING: Breakageandwear-outof
the inserts. In rare cases, high frequency
the fragments of the insert are retrieved
and removed from the surgical site and, at
applied. Unremoved fragments may cause
tissue damage to the patient.
Do not modify the insert in any way,
otherwise its performance could be
diminished. Bending, prying or deforming the
must never be used.
therefore forbidden. Always inspect the insert
before and during the operation especially in
its apical part for any damage. If damaged is
observed replace with a new insert.
During surgery, avoid prolonged contact with
retractors or other metal objects being used,
during their use, otherwise it may fracture
resulting in harm to the patient or users.
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
Do not resterilize
Sterilized with Ethylene
autoclave up to a
recommendation
pedal
I Activation switch “on” 0
Functional earth
Biohazard
accessories must not be
disposed of or treated
as solid urban wastes
6
flex
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
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
Table1 – Symbols
2 IDENTIFICATIONDATA
2.1 DeviceIdenticationLabel
label that reports the main technical
characteristics and the serial number.
on page 26
.
manufacturer
Mectron S.p.A.
Via Loreto 15/A
16042 Carasco -GE- Italy
413000000
PIEZOSURGERY flex
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
device.
NOTE:
their description are shown in
1.5 on page 5
.Device for intermittent operation:
60 s ON - 30 s OFF with irrigation
PIEZOSURGERY flex
2.2 HandpieceIdenticationData
Figure 1 at page
•
•
• its date of manufacturing;
• the device name (PIEZOSURGERY®
medical
• the Mectron logo;
•
•
symbols.
NOTE:
description are shown in
5.
flex
PIEZOSURGERY®
medical
HIBC 128
Data Matrix
medical
408000000
03120127
0051
YYYY-MM
Figure1 –
2.3 InsertsIdenticationData
each insert:
•
•
• the lot number to which the insert
•
MT1-10
A A/XXXXX
1 2 3 4
3 DELIVERY
3.1 ListoftheComponentsofthePIEZOSURGERY®ex
Refer to the front endpaper.
A.
pump;
B. Drip stands for supporting the saline
bags;
Power supply cable with hospital grade
plug;
D.
connector;
E.
•
•
sterilizing manual.
from the device:
F.
G. PIEZOSURGERY® medical single use
H. PIEZOSURGERY® medical handpiece
complete with cord and the connector
protective cap (supplied NON sterile
CAUTION:
cannot be separated.
I. PIEZOSURGERY® medical torque
wrench (supplied NON sterile and
that can be ordered separately.
strong impacts as contains electronic
components, therefore the transport and the
storage must be carried out with particular
care. All material shipped by Piezosurgery Inc.
have been inspected upon they delivery.
possible damage caused during transport and
complain to the transporter.
Service and to store the device during long
periods of inactivity.
WARNING: Before starting to operate
case the device stops due to a fault or of
inconveniences.
10
flex
4 FIRST INSTALLATION
must be installed by a person authorized by
in a suitable place that is handy for its use.
place suitable for its use.
Position the device in way so that the power
plug is always, easily reachable, since this plug
is considered as a disconnecting means.
to Mectron S.p.A. to ensure traceability and
the warranty activation.
4.1 SafetyRequirementsintheInstallationPhase
WARNING: Contraindications.
Interferencewithotherequipment.
it may interfere with other devices in its
steps are necessary to eliminate or
reduce the source of interference. Install
the device is necessary, normal operation of
WARNING: Contraindications.
Interferencebyotherequipment. An
may interfere with its correct functioning.
WARNING: Riskofexplosion.
device cannot operate in environments where
WARNING
to which the device is connected must
comply with all the applicable standards and
with electrical safety requirements.
WARNING
connect the console to hospital grade
receptacle to ensure electrical grounding
reliability.
WARNING: Do not operate the foot
pedal of the when
the peristaltic pump cover is open. Moving
parts
Personal injuries may result.
WARNING: Install the device in a place
protected against impacts or accidental
splashes of water or other liquids.
WARNING: Do not install the device on
top of or close to sources of heat. Adequate
air circulation is needed to cool electronic
the cooling fans at the console area and at
the console bottom. Do not place the unit
on a towel, foam or other soft surface since
console bottom.
CAUTION
direct sunlight or sources of UV light.
CAUTION
but must be handled with care when moved.
way that it can only be activated intentionally
by the operator.
CAUTION: Theelectricalcontacts
insidethecordconnectormustbedry.
Upon completion of the sterilisation cycle
and before connecting the handpiece cord
contacts of the connector are perfectly dry.
If necessary, dry the contacts by blowing air
onto them with medical compressed air.
CAUTION: Do not allow the device
console and the foot pedal to get wet. If
liquid enters the console or footswitch,
damage could occur.
11
CAUTION
equipment is allowed.
4.2 Connecting the Accessories
with an additional equipotential plug
located on the rear of the console.
Insert the connector of the equipotential
of potential which can occur during
conductive parts of other objects within
the medical environment;
1
Plug the power supply cord into the
and then into the mains power outlet;
2
NOTE:
moved to the place most suitable for the
operation, without the need to use your
hands to move it.
horizontally if it is not used;
3
12
flex
the symbol , by means of the plug of
sound.
In order to disconnect the foot pedal
from the device grab the connector of
NOTE: MANUALSTARTSTOPBUTTON
intraoperatively, the button allows
. Refer to .
4
Fit the drip stand for supporting the
solution bag into the dedicated hole;
5
STEPS TO BE CARRIED OUT IN THE
“STERILEAREA”:
and the clips;
onto the dedicated handpiece irrigation
nozzle;
Use the 6 clips provided in order to
clip together the irrigation tubing and
handpiece cable;
6
13
STEPS TO BE CARRIED OUT IN THE
“NOTSTERILEAREA”:
• Open the pump cover completely;
7
• Insert the part of the irrigation tube
with a bigger diameter and with
length of 15 cm into the peristaltic
pump;
WARNING:Use only original
not use irrigation tubings other than
•
WARNING: Do not operate the
when the peristaltic pump cover is open.
Moving parts might pinch loose clothing
8
stand;
Remove the protective cap from the
WARNING:
support rod must be used with bags of
WARNING:
proceed with the proper disposal.
9
14
flex
Open the air inlet on the tube before
operating. Release the irrigation tube
clamp, if this is closed;
10
insert the connector of the handpiece
connector until it bottoms out.
CAUTION
when disconneting the cord. Always hold
the cord by its connector. Never pull on
the cord itself.
11
Other manuals for Piezosurgery flex
1
Table of contents
Other mectron Dental Equipment manuals
mectron
mectron starlight p x5 User manual
mectron
mectron COMPACT PIEZO LED User manual
mectron
mectron Starlight Pro User manual
mectron
mectron STARJET User manual
mectron
mectron MICROPIEZO User manual
mectron
mectron OzoActive User manual
mectron
mectron COMPACT PIEZO LED User manual
mectron
mectron starlight s + User manual
mectron
mectron compact piezo P2K User manual
mectron
mectron Silverlight Instruction manual
mectron
mectron Piezosurgery User manual
mectron
mectron STARLIGHT UNO User manual
mectron
mectron Piezosurgery flex User manual
mectron
mectron Piezosurgery II User manual
mectron
mectron Piezosurgery User manual
mectron
mectron MULTIPIEZO PRO User manual
mectron
mectron Starlight Pro User manual
mectron
mectron PIEZOSURGERY GP User manual
mectron
mectron compact piezo P2K User manual
mectron
mectron PIEZOSURGERY plus User manual
Popular Dental Equipment manuals by other brands
Donaldson
Donaldson BOFA DentalPRO Xtract 200 user manual
Renfert
Renfert Basic quattro 2954-0005 instruction manual
Renfert
Renfert Waxlectric light II Faq
Renfert
Renfert SILENT powerCAM TC manual
Zhermack
Zhermack Hurrimix DepoDent quick guide
DentalEZ
DentalEZ StarDental Titan 3 Five Star instruction manual
