mectron Multipiezo User manual
0051
multipiezo
USE AND MAINTENANCE MANUAL
U.S. Federal law restricts this device to sale by or on
the order of a licensed dentist or dental hygienist.
M
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2 57
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Copyright
© Mectron S.p.A. 2022. All rights reserved. No part of this document may be reproduced, in any
form whatsoever, without the prior written consent of the copyright holder.
II
multipiezo
TABLE OF CONTENTS
1 Introduction 1
1.1 Intended Use 1
1.2 Description of the Device 2
1.3 Disclaimer 2
1.4 Safety Requirements 3
1.5 Symbols 6
2 IdenticationData 7
3 Delivery 9
3.1 List of Components 9
4 Installation 11
4.1 First Installation 11
4.2 Safety Requirements During Installation 11
4.3 Connecting the Accessories 12
5 Use 14
5.2 Description of the Keyboard 15
5.3 Safety Requirements Before and During Use 20
5.4 Instructions for Use 22
5.5 Important Information on the Inserts 24
6 FlushFunction 26
7 DisassemblingPartsforCleaningandSterilisation 28
8 CleaningandSterilisation 31
9 Maintenance 50
10 MethodsandPrecautionsforDisposal 52
11 TechnicalData 52
III
12 Troubleshooting 61
12.1 Diagnostic System and Symbols on the Keyboard 61
12.3 Replacing the Fuses 65
12.4.1 Repairs 66
12.4.2 Returned Goods 66
13 Warranty 67
IV
multipiezo
PAGELEFTINTENTIONALLYBLANK
1
1 INTRODUCTION
1
Read this manual and follow its instructions
carefully before proceeding with the
installation, use, maintenance, or other
this manual within easy reach.
IMPORTANT: to avoid potential serious
or this device or other equipments, read
all the “Safety precautions” present in the
WARNING, CAUTION and NOTE contained
in this document, carry special meaning
and must be carefully reviewed. Depending
on their degree of seriousness, the safety
WARNING
CAUTION
practices that could result in minor injury or
NOTE:
or emphasize important instructions.
precautions, the installation procedures,
and the instructions for a correct use and
maintenance of the device and its accessories.
Use of this manual for purposes other than
those strictly tied to the installation, use and
maintenance of the device is forbidden.
manual are updated as of the date of issue
reported on the last page.
Mectron is committed to continuously update
device components.
In case you encounter discrepancies between
the descriptions found in this manual and the
device in your possession you can:
•
website
1
;
•
•
Service.
1.1 Intended Use
multipiezo is a piezoelectric ultrasonic dental scaler intended for use, with the appropriate
associated tip inserts, in the following dental applications:
• Scaling: all general procedures for
deposits;
• Periodontology: periodontal therapy
and debridement for all types of
periodontal diseases, including
cleaning;
• Endodontics: all treatments for root
canal reaming, irrigation, revision,
retrograde preparation;
• Restorativeandprosthetics: all general
restorative procedures including cavity
preparation, removal of prostheses,
cleaning.
2
multipiezo
WARNING
in a dental practice, in a clinic, or in a
professional oral hygiene and preventive
care centres. Do not use the device in
environments where the atmosphere
WARNING: Qualiedandspecialised
personnel.
a dentist, or dental hygienist, with suitable
used correctly. An improper use might cause
tissues heating.
WARNING: Intended use. Use the device
exclusively for the use for which it is intended.
Failure to observe this regulation can cause
serious injury to the patient, the operator,
1.2 DescriptionoftheDevice
multipiezo is a multifunctional ultrasonic
piezoelectric scaler. It has been designed
design and exclusive technical characteristics
to the operator, and maximum comfort during
the treatment to the patient.
all the functions readily available by integrating
has a circular LED light and can be autoclaved
circuit which optimizes frequency and power
for each available insert, so that the best
performance is always assured.
1.3 Disclaimer
liability, expressed or implied, and shall have
no responsibility for any direct or indirect
occurring as a result of incorrect procedures
in the use of the device and its accessories.
no liability, expressed or implied, for any type
which might arise or be caused, whether by
the customer or by any of the users of the
product and its accessories, as results of the
following conditions, by way of example and
not limitated to:
• Misuse or use during procedures other
of the product;
•
preservation and storage of the device
are not complying with the requirements
indicated in
Chapter 11 on page 52
;
•
with all the instructions and precautions
described in this manual;
•
which the device is used is not compliant
with the applicable regulations and with
the electrical safety requirements;
•
adjustments, upgrades and repairs of the
device are carried out by personnel not
• Misuse, abuse, abnormal use, negligent
use, intentional misconduct or use
exceeding the limits of the device
or incorrect interventions;
• Any attempt to tamper with or
circumstance;
•
resulting in permanent damage to the
thread of the handpiece with impaired
patient;
3
•
used in accordance with the settings
designed and tested on the original
settings is only guaranteed with original
•
standstill due to faults or problems;
•
compared to what is stated in
Chapter 9
on page 50
of this manual;
• Breach of the requirements and the
information contained in
Chapter 5.5 on
page 24
of this manual;
• Breach of the requirements and the
information contained in
page 31
of this manual;
• Unauthorised repairs in accordance with
the indications contained in
Chapter 12.4
on page 66
this manual.
1.4 SafetyRequirements
WARNING: Contraindications.
Do not use the multipiezo on patients who
precaution also applies to the operator.
WARNING: Contraindications. Do not
perform scaling treatments without water
heating which may cause damages to the
do not have the water passage.
CAUTION: Contraindications.Ultrasonic
scaler. Do not perform treatments on metal
loosening of such artifacts.
WARNING: Contraindications.
Interferencefromotherequipment.
An electrosurgical scalpel or other
electrosurgical units positioned near the
multipiezo device may interfere with its
correct operation.
WARNING: Contraindications.
Interferencewithotherequipment.
whatever steps are necessary to eliminate
or reduce the source of interference. Install
support systems. multipiezo must not be
the device is necessary, normal operation
of the equipment and multipiezo, in the
WARNING: Riskofexplosion.
device cannot operate in environments where
4
multipiezo
CAUTION: In case the end user, when
operating in his or her own medical study
equipment and systems to periodical
inspections in order to adhere to imposed
requirements, the test procedures that must
and systems to evaluate safety must be
performed in line with the standard EN 62353
inspections and tests to be carried out after
frequency of periodic inspections in the
intended conditions of use described in this
“Use and Maintenance” manual is once per
year or every 2000 hours of use, whichever
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
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: ControlofInfections.
• First Use.
accessories(brand new or returned by
prepared prior to use by applying the
procedures described in the
on page 31
.
• Everyuse.
accessory must be thoroughly
reprocessed prior to reuse, according to
the procedures described in the
Chapter
31
.
WARNING: Diamondcoatedinsertsare
intendedforsingleuseonly.
CAUTION: Contraindications. Allow
autoclavable items (the handpiece, the
inserts, the torque wrench, and any other
return to room temperature after steam
process must not be accelerated.
WARNING
inserts, accessories, and spare parts.
CAUTION
equipment is allowed.
WARNING
components must be inspected for damage.
Do not use if damage is apparent.
WARNING: Do not operate the device if
Immediately replace the handpiece.
WARNING
that power cable do not interfere with free
circulation of people in the area.
5
WARNING: Breakageandwear-outof
the inserts. High frequency oscillations and
Deformed or otherwise damaged inserts are
that none of its fragments remain in the
treated part and, at the same time, apply
through his nose during the treatment, or
a dental dam must be used to prevent the
inserts.
its integrity before and during each use.
If a drop in performance occurs, see to its
replacement.
•
indicating the limit of wear;
• If the insert is shorter than the limit of
inferior compared to that of a new insert,
and should therefore be replaced.
that the insert is not worn out. During the
is intact, especially in its apical part.
During the intervention, avoid prolonged
contact with retractors or with metallic
instrumentation in use. Do not exert excessive
pressure on the inserts during their use.
NOTE: In case of accident attributable to the
device during correct use and in accordance
with the intended use, a report must be
made to the Competent Authority and
manufacturer indicated on the product label.
6
multipiezo
1.5 Symbols
Symbol Description Symbol Description
0051
Device compliant
body: IMQ S.p.A.
CSA regulations
Medical device Caution!
Consult instructions
for use or consult
electronic instructions
for use
Manufacturer
Date of manufacture Serial number
Batch number
Not sterile
materials must be
autoclaved and can
resist up to a maximum
temperature of 135°C
according to regulation
Alternating current
Connection of the
control pedal
Generic warning signal
I 0
accessories must not be
disposed of or treated
as municipal solid waste
transport and storage
Moisture limits for
transport and storage
Atmospheric pressure
limits for transport and
storage
Symbol Description Symbol Description
Rx only
CAUTION: U.S. Federal
law restricts this device
to sale by or on the
order of a licensed
dentist or dental
hygienist.
Table1 – Symbols
NOTE: For other symbols, refer to
Chapter
12.1 on page 61
.
2 IDENTIFICATIONDATA
A correct description of the model and of
the serial number of the device will allow the
support.
Always provide this information every time
2.1 IdenticationPlateoftheDevice
Each device is equipped with an
technical characteristics and serial
on the bottom of the device’s console.
provided in
Chapter 11 on page 52
.
NOTE:
provided in
Chapter 1.5 on page 6.
manufacturer
Mectron S.p.A.
Via Loreto 15/A
16042 Carasco -GE- Italy
106000000
multipiezo
100-240 V~90 VA - 50/60 Hz.
Rx Only
0051
00000000 YYYY-MM-DD
made in Italy
Bar Code HIBC 128
Additional symbols and characteristics
of the device are provided on a separate
on the bottom of the device’s console.
NOTE:
provided in
Chapter 1.5 on page 6.
multipiezo
Device for intermittent operation:
55 s ON - 30 s OFF with irrigation
30 s ON - 120 s OFF without irrigation
multipiezo
2.2 HandpieceIdenticationData
serial number, product code, HIBC matrix
NOTE:
provided in
Chapter 1.5 on page 6.
YYYY-MM
YYYY-MM
0476
0051
114000000
03120000
107000000
03120238
114000000
03120238
0476 0476
0051
0051
YYYY-MM
MANIPOLO ABLATORE
SLIM
MANIPOLO ABLATORE
SLIM
MANIPOLO ABLATORE
SLIM
114000000
03120238
0476
0051 YYYY-MM
MANIPOLO ABLATORE
SLIM Data Matrix
HIBC 128
2.3 InsertsIdenticationData
1 2 3
9
3 DELIVERY
3.1 ListofComponents
See the Figure on the inside cover.
multipiezo is supplied with the standard
equipment (see
of variable accessories depending on the
3 on page 10
ordered separately (see
NOTE: Both the items included in the
standard supply and all accessories can be
ordered separately by the client.
Standardsupply
Item Code Description Ref.
Device core unit 04000100 A
cap 03150102 B
with cord and plug 02900114 C
01950014 Grey safety cap D
01950015 Blue safety cap
E
Scaler Handpiece
( F
H
Use and Maintenance Manual US version
K
Documentation 02150650
HG 2m USA L
Table2 – Standard supply.
10
multipiezo
Accessoriesavailablefororderwithstandardsupply
Item Code Description Ref.
K10 torque wrench I
Insert tips 0296xxxx "S” series reusable scaler inserts J
0305xxxx “R” series reusable scaler inserts
0345xxxx “ER” series reusable scaler inserts
0235xxxx “E” series reusable scaler inserts
0299xxxx “D” series reusable scaler inserts
0219xxxx “CM” series reusable scaler
inserts
“ICS” series reusable base insert
03590009 "IC1” series tip
02900112
Table3 – Accessories available for order with standard supply.
Accessoriesavailableforseparateorder
Item Code Description Ref.
Scaler Handpiece 03120142
M
Front cone for LED handpiece Front cone for LED SCALER
N
02900146
Front cone, light guide and
decorative ring for SLIM scaler
handpiece
Front cone without light Front cone for LED SCALER
G
001
Table4 – Accessories available for separate order.
11
Distributed by Mectron.
strong impacts as contains electronic
components, therefore the transport and the
storage must be carried out with particular
care.
been inspected upon their delivery.
possible damage caused during transport and
complain to the transporter.
and to store the device during long periods
of inactivity.
WARNING: Before starting the treatment,
4 INSTALLATION
4.1 FirstInstallation
place that is convenient for its use.
NOTE:
must meet the requirements reported in
Chapter 4.2 on page 11
.
horizontal surface.
CAUTION: Always position the device
in way so that the power switch is easily
reachable, since this switch is considered as a
4.2 SafetyRequirementsDuringInstallation
WARNING: Contraindications.
Interferencewithotherequipment.
whatever steps are necessary to eliminate
or reduce the source of interference. Install
support systems. multipiezo must not be
the device is necessary, normal operation
of the equipment and multipiezo, in the
WARNING: Contraindications.
Interferencefromotherequipment.
An electrosurgical scalpel or other
electrosurgical units positioned near the
multipiezo device may interfere with its
correct operation.
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.
12
multipiezo
WARNING: Riskofexplosion.
where there are saturated atmospheres of
WARNING: Install the device in a safe
place protected against impacts or accidental
splashes of water or other liquids.
WARNING: Do not install the device
above or near heat sources. Foresee
adequate air circulation around the device
when installing it.
CAUTION: Do not expose the device to
direct sunlight or to sources of UV light.
CAUTION
but must be handled with care when moved.
can only be activated intentionally by the
operator.
CAUTION: Before connecting the
contacts are perfectly dry, on both sides. If
necessary dry them with compressed air.
CAUTION
to a maximum of 500 ml.
CAUTION: Always position the device
in way so that the power switch is easily
reachable, since this switch is considered as a
4.3 Connecting the Accessories
by
inserting the pedal cord plug until you
WARNING:
positioning of the pedal, which must be
only be activated intentionally by the
operator.
1
console.
2
13
the needed solution;
CAUTION
liquids up to a maximum of 500 ml.
NOTE:
and sterilised all parts, and before a
without having used the device, it must
be emptied at the end of the day, and all
parts and accessories must be cleaned
and sterilised.
3
CAUTION
free from obstructions.
4
CAUTION
coupling on the device core unit is clean
NOTE: Use the support only to install the
handpiece. Do not use the support for
other purposes.
push it towards the unit’s core until it is
CAUTION: Do not capsize the
of aggressive liquids can damage the
sufaces.
5
14
multipiezo
Correctly connect the scaler handpiece
onto its cord by matching the alignment
notch on the handpiece connector with
are perfectly dry and if necessary dry
them by blowing with compressed air;
6
NOTE Use the support only to install the
handpiece. Do not use the support for
other purposes.
7
5 USE
5.1 PowerOn/O
Switchingthedeviceon
side of the console.
Switchingthedeviceo
side of the console.
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