mectron compact piezo P2K User manual
USE AND MAINTENANCE MANUAL
compact piezo P2K
U.S. Federal law restricts this device to sale by or on
the order of a licensed dentist or dental hygienist.
0051
COMPACT PIEZO P2K
I
Copyright
© Mectron S.p.A. 2022. All rights reserved. No part of this document can be reproduced in any
form without the written consent of the copyright owner.
II
COMPACT PIEZO P2K
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 Precautions 3
1.5 Symbols 5
2 IdenticationData 6
3 Delivery 7
3.1 List of components 7
4 Use 11
4.1 Commands 11
4.3 Safety Precautions Before and During Use 11
4.4 Instructions for Use 13
4.5 Important Information on the Insert Tips 15
5 DisassemblingofPartsforCleaningandSterilization 16
6 CleaningandSterilization 18
7 Maintenance 32
8 DisposalMethodsandPrecautions 32
9 TechnicalSpecications 33
10 Troubleshooting 41
11 Warranty 44
III
IV
COMPACT PIEZO P2K
PAGEINTENTIONALLYLEFTBLANK
1
1 INTRODUCTION
carefully before proceeding with the
installation, use, maintenance, or other
this manual within easy reach.
IMPORTANT: to avoid potential serious
all the “Safety precautions” present in the
manual with particular attention. The words
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:
precautions 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 use and maintenance
of the device is forbidden.
The information and illustrations in this
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:
•
the
website
1
;
•
•
Service.
1.1 Intended Use
associated insert tips, in the following dental applications:
• Scaling: Procedures for removal
• 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:
preparation, removal of prostheses,
cleaning.
WARNING: The device must be used
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
2
COMPACT PIEZO P2K
WARNING: Qualiedandspecialized
personnel.The device is intended exclusively
for use by a dentist, or dental hygienist, with
used correctly. An improper use might cause
tissues heating.
WARNING: Intended Use. Use the
device only for the intended use.
serious injuries to the patient, the operator,
1.2 DescriptionoftheDevice
innovative design, exclusive technical
characteristics and maximum comfort to the
range of possible power settings.
The device has an automatic sync circuit which
available insert tip, in order to always assure
the best performances.
1.3 Disclaimer
The manufacturer Mectron disclaim any
liability, expressed or implied, and shall have
no responsibility for any direct, indirect or
other damages and personal injury arising out
in connection with any errors in the use of the
device and its accessories.
The manufacturer Mectron shall be under no
liability, expressed or implied, with respect to
whether by the customer or by any of the
users of the product and its accessories, as
result of:
•
product;
• The environmental conditions for the
preservation and storage of the device
are not compliant to the precautions
indicated in the
32
;
• The device is not used in compliance
with all the instructions and precautions
described in this manual;
• The electrical system in the premises in
which the device is used is not compliant
to the norms in force and to the relative
precautions;
• The assembly operations, extensions,
adjustments, updates, and repairs on the
device are performed by personnel not
• Misuse, abuse, abnormal use, negligent
use, intentional misconduct or use
exceeding the limits of the device
or incorrect interventions;
• Any and all attempts to tamper with
or modify the device, under any
circumstance;
•
the threading of the handpiece, thus
compromising correct operation and
•
tips, used in accordance to designed
original insert tips. The correct use of the
settings is guaranteed only with original
•
event of device stop due to fault or of
inconveniences;
•
compared to what is stated in
Chapter 7
on page 31
of this manual;
•
information contained in
Chapter 4.5 on
3
page 14
of this manual;
•
information contained in
page 17
of this manual;
•
the indications contained in
Chapter 10.2
on page 42
of this manual.
1.4 SafetyPrecautions
WARNING: Contraindications.
Do not use the device on patients who
other implantable electronic devices. This
precaution also applies to the operator.
WARNING: Contraindications. Do not
perform scaling treatments without water
heating which may cause damages to the
tooth. Treatments with no water spray can be
which do not have the water passage.
CAUTION: Contraindications.
Ultrasonicscaler. Do not perform treatments
on prosthetic artifacts made of metal or
ceramics. The ultrasonic vibrations could lead
WARNING: Contraindications.
Interferencefromotherequipment.
interfere with its correct operation.
WARNING: Contraindications.
Interferencewithotherequipment.
interfere with other devices nearby.
monitor correct operation of the device in
WARNING: Riskofexplosion. The
device cannot operate in environments where
CAUTION: In the case that the end
user, when operating in his or her own
medical study or clinic, must subject the
periodical inspections in order to adhere to
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 or 2000 hours of use,
depending on which of these two conditions
WARNING: Checkingdevicestatus
beforethetreatment. Before every
DO NOT perform the treatment. Contact an
the abnormalities concern the device.
WARNING: Cleaningandsterilising
neworrepairedinstruments. All the new
or repaired device accessories are not sterile.
following the instructions in
page 17
.
WARNING: Diamond coated insert tips
are SINGLEUSEONLY. The diamond coated
insert tips are intended to be used on an
individual patient during a single treatment
procedure and then disposed of. The
4
COMPACT PIEZO P2K
WARNING: Infectionscontrol.
To ensure maximum safety of the patient and
the operator, before using all the reusable
the instructions of the
17
.
CAUTION: Contraindications. Allow
reusable, autoclavable items (the handpiece,
gradually return to room temperature after
cooling process must not be accelerated.
WARNING: Breakageandwear-outof
the insert tips.
Deformed or otherwise damaged insert tips
These insert tips must never be used.
fragments remain in the treated part and,
remove them.
The patient must be instructed to breathe
through his nose during the treatment, or
a dental dam must be used to prevent the
insert tips.
its integrity before and during each use. If
there is a decrease in performance, replace
it. The level of wear of the most common
correctly:
•
printed on the card has a red line
indicating the wear limit;
• If the insert tip has a length less than
the wear limit, its performance will be
of a new one and replacement is
recommended.
If the layer of titanium nitride (golden
insert tip must be replaced. The use of a worn
the insert tip damages it and is therefore
worn out.
the insert tip 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 insert tips during their use.
WARNING: OnlyuseoriginalMECTRON
inserttips,accessories,andspareparts.
CAUTION:
WARNING: Prior to any use, system
components must be inspected for damage.
Do not use if damage is apparent.
WARNING: Do not operate the device if
Immediately replace the handpiece.
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.
5
1.5 Symbols
Symbol Description Symbol Description
0051
Device compliant
body: IMQ S.p.A.
CAUTION, See
instructions for use.
Consult instructions
for use
Manufacturer Date of manufacture
YYYY
Manufacturer, year of
manufacture included
Serial Number
Lot Number Product Number
Expiring date
autoclave up to a
maximum temperature
of 135° C
Applied part of type
recommendation
Alternating current
Direct Current Dangerous voltage
The device and its
accessories must not be
disposed of or treated
as solid urban wastes
indication
Temperature limitation
conditions
transport and storage
conditions
Atmospheric pressure
and storage conditions
Quantity of items in the
COMPACT PIEZO P2K
Symbol Description Symbol Description
CAUTION:
law restricts this device
to sale by or on the
order of a licensed
hygenist.
Table1 – Symbol The symbol is represented by a yellow warning
2 IDENTIFICATIONDATA
A correct description of the model and of the
serial number of the device will allow the After
answers.
Always provide this information every time
Service.
2.1 HandpieceIdenticationData
serial number, product code, HIBC matrix
code, and a series of symbols are laser
engraved on the scaler handpiece.
NOTE: The complete list of symbols is
provided in Chapter 1.5 on page 5.
102000000
03120016
0051 YYYY-MM
YYYY-MM YYYY-MM
0051
0051
03120000
102000000
03120016
0051
102000000
03120016
YYYY-MM
MANIPOLO
ABLATORE
MANIPOLO
ABLATORE
MANIPOLO
ABLATORE
MANIPOLO
ABLATORE
Bar Code
HIBC 128
2.2 InsertTipsIdenticationData
the
lot number to which the insert belongs
2 3 4
7
3 DELIVERY
3.1 Listofcomponents
See
.
Table 2 a pagina
7
can be ordered separately (see Table 4 a
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 A
Cord B
Scaler Handpiece
C
Use and Maintenance Manual US version
Installation Manual US version
Information: Online
Documentation
Table2 – Standard supply.
Accessoriesavailablefororderwithstandardsupply
Item Code Description Ref.
D
Inserts "S” series reusable scaler inserts E
“PE” series reusable scaler inserts
0305xxxx
0345xxxx
0235xxxx “E” series reusable scaler inserts
COMPACT PIEZO P2K
Accessoriesavailablefororderwithstandardsupply
Item Code Description Ref.
“D” series reusable scaler inserts
“CM” series reusable scaler
inserts
03570004 “ICS” series reusable base insert
"IC1" tip
Layout A
Layout B
Table3 – Accessories available for order with standard supply.
Accessoriesavailableforseparateorder
Item Code Description Ref.
Nose cone without light 03020171 H
Table4 – Accessories available for separate order.
Produced 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.
The device is shipped duly protected and
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,
E F
D
A
G H
B C
Figure1 – List of components
10
COMPACT PIEZO P2K
4 USE
4.1 Commands
4.2 SwitchingtheDeviceOnandO
4.3 SafetyPrecautionsBeforeandDuringUse
WARNING: Before starting to operate
available to use in case the device fails or to
inconveniences.
WARNING: OnlyuseoriginalMectron
inserttips,accessories,andspareparts.
WARNING: Useofnon-original
Mectroninserttips:
damage to the handpiece threading, thus
to cause harm to the patient.
CAUTION: Contraindication.Ultrasonic
scaler. Do not perform treatments on
prosthetic artifacts made of metal or
ceramics. The ultrasonic vibrations could lead
WARNING: Contraindications. Do not
other implantable electronic devices. This
precaution also applies to the operator.
WARNING: Contraindications.Do not
perform scaling treatments without water
heating which may cause damages to the
tooth. Treatments with no water spray can be
which do not have the water passage.
CAUTION: Only use insert tips with water
passage when performing treatments that
WARNING: Treatmentsthatrequire
irrigation.
Do not use the device if the irrigation does
WARNING: Before every treatment,
of operating abnormalities, DO NOT perform
abnormalities concern the device.
CAUTION: To correctly operate with the
device, press the foot pedal and activate it
with the insert tip not in contact with the part
to be treated, so that the electronic circuit
the insert tip without interferences, allowing
its optimal performance.
WARNING: Before every treatment,
the treatment is inserted on the handpiece.
fasten the insert tip to the handpiece.
WARNING: Do not change the insert tip
while the handpiece is operating, to prevent
causing wounds to the operator. During the
intervention on the patient, do not perform
11
USE
WARNING: Cleaningandsterilising
neworrepairedinstruments. All the new
or repaired device accessories are not sterile.
following the instructions in
page 17
.
WARNING: Diamond coated insert tips
are SINGLEUSEONLY. The diamond coated
insert tips are intended to be used on an
individual patient during a single treatment
procedure and then disposed of. The
WARNING: Infectionscontrol.
To ensure maximum safety of the patient and
the operator, before using all the reusable
the instructions of the
17
.
CAUTION: Contraindications. Allow
reusable, autoclavable items (the handpiece,
gradually return to room temperature after
cooling process must not be accelerated.
CAUTION: Theelectricalcontactsof
bothhandpieceandcordconnectorsmust
bedry. Before connecting the handpiece
contacts of both connectors, are perfectly
autoclave. If need be, dry the contacts by
blowing compressed air onto them.
WARNING: Breakageandwear-outof
the insert tips.
Deformed or otherwise damaged insert tips
These insert tips must never be used.
fragments remain in the treated part and,
remove them.
The patient must be instructed to breathe
through his nose during the treatment, or
a dental dam must be used to prevent the
insert tips.
its integrity before and during each use. If
there is a decrease in performance, replace
it. The level of wear of the most common
correctly:
•
printed on the card has a red line
indicating the wear limit;
• If the insert tip has a length less than
the wear limit, its performance will be
of a new one and replacement is
recommended.
12
COMPACT PIEZO P2K
If the layer of titanium nitride (golden
insert tip must be replaced. The use of a worn
the insert tip damages it and is therefore
worn out.
the insert tip 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 insert tips during their use.
WARNING:
pointed insert tips with particular care. During
could cause harm.
4.4 InstructionsforUse
Correctly insert the scaler handpiece
on its cord by aligning the dot on the
connector of the handpiece with the
groove on the connector of the cord.
are perfectly dry and if necessary dry
them by blowing with compressed air.
1
Screw the insert tip selected on the
handpiece until it stops.
2
13
USE
3
CAUTION: Do not grab the
wrench. Do not rotate the body during
tightening.
engages the clutch (the outer body of the
wrench rotates with respect to the body
of the handpiece producing mechanical
4
click!
to the indications provided by the
5
in the indications provided by the
6
using the proper commands described
into the instructions provided by the
The device is provided with a
sophisticated electronic circuit which
enables the scaler to compensate
the wear of the insert tip, thus always
maintaining a high performance level of
the ultrasound generator.
7
14
COMPACT PIEZO P2K
At the end of the treatment, place the
8
4.5 ImportantInformationontheInsertTips
WARNING:
• Diamondcoatedinserttipsare
SINGLEUSE.The diamond coated
insert tips are intended to be used on
an individual patient during a single
surgical procedure and then discarded.
The diamond coated insert tips cannot
therefore be reprocessed since they
cannot be cleaned properly. Soil
residues might remain adhered to the
diamond coating even after cleaning and
of another patient.
•
visibly worn out, the insert tip must be
replaced. Use of an overly worn out
• Do not activate the handpiece while the
insert tip is in contact with the treated
part, so that the electronic circuit can
of the insert tip and allow its optimal
performance.
• Always inspect the insert tip before and
during the operation for any damage.
If a damage or drop in performance is
noted replace it with a new one. Insert
tip showing signs of deformation or
• Use original Mectron insert tips only. Use
to voiding the warranty, damages the
being able to screw the original insert
Moreover, the device settings are tested
and guaranteed to operate correctly
only when original Mectron insert tips
are used.
• Do not change the shape of the insert
•
any type of deformation.
• Do not attempt to sharpen the insert tip
used.
•
the insert tip and of the handpiece are
perfectly clean – see
17
.
•
exert excessive pressure on the inserts
during use. Apply a light force on the
• The Mectron inserts vibrate with a
longitudinal oscillation, with forward and
the tooth surface. Move the handpiece
lateral pressure.
• Do not aim the instrument directly on
the surface of the enamel or implant.
tangentially to the surface of the tooth
or implant.
•
instrument or leverage the operative
part. The inserts must be left free to
vibrate.
• In the treatment of endodontic root
when they are outside the root canal
as straight as possible to limit creases
in the insert. Use a light movement.
canal, do not allow contact between the
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