mectron compact piezo P2K User manual
0051
USE AND MAINTENANCE MANUAL
COMPACT PIEZO P2K
COMPACT PIEZO P2K
I
Copyright
© Mectron S.p.A. 2021. 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
COMPACT PIEZO P2K
CONTENTS
1 Introduction 1
1.1 Intended Use 1
1.2 Description of the Appliance 2
1.2.1 Eligible Patient Group 2
1.2.2 Patient Selection Criteria 2
1.2.3 Indications for Use 2
1.2.4 Users 3
1.3 Disclaimer 3
1.4 Safety Requirements 4
1.5 Symbols 6
2 IdenticationData 7
3 Delivery 8
3.1 List of components 8
4 Use 12
4.1 Controls 12
4.3 Safety Requirements Before and During Use 12
4.4 Instructions for Use 14
4.5 Important information on the Inserts 16
5 DisassemblingPartsforCleaningandSterilisation 17
6 CleaningandSterilisation 19
6.1 Cleaning the Sterilisable Accessories 19
6.1.1 Manual Cleaning 19
6.1.1.1 Required Materials 19
6.1.1.2 Scaler Handpiece 20
6.1.1.3 Inserts 21
6.1.1.4 Inserts Tightening Wrench 24
6.1.2 Automatic Cleaning 25
6.1.2.1 Required Materials 25
6.3 Drying and Lubrication 28
6.3.1 Required Materials 28
6.4 Sterilisation 29
6.4.1 Preparation 29
6.4.2 Sterilisation Method 30
6.4.2.1 Special Information 31
7 RoutineMaintenance 31
8 MethodsandPrecautionsforDisposal 31
9 TechnicalData 32
9.1 Electromagnetic Compatibility IEC/EN 60601-1-2 33
9.1.1 Guide and Manufacturer’s Declaration - Electromagnetic Emissions 33
9.1.2 Accessible Parts of the Casing 34
9.1.3 Guide and the Manufacturer's Declaration - Electromagnetic Immunity 35
9.1.3.1 Power Connection BC Input 35
9.1.3.3 Parts Accessible to the Input / Output Signals 38
III
Casing to the Wireless RF Communications Device 39
10 Troubleshooting 40
10.1 Quick Troubleshooting 40
10.2 Shipping to an Authorised Mectron Service Centre 42
11 Warranty 43
IV
COMPACT PIEZO P2K
PAGELEFTINTENTIONALLYBLANK
1
INTRODUCTION
1 INTRODUCTION
1 http://mectron.it/en/technical-support/users-manuals/
Carefully read this manual before proceeding
with installation operations, use, maintenance
or other intervention operations on the
appliance.
This manual must always be available to the
operator.
Important: To avoid damages to persons
or property, carefully read all the "Safety
Requirements" in the manual.
Depending on the level of severity, the safety
indications:
WARNING: (Always referred to damage
to persons)
CAUTION: (Referring to possible damage
to property)
The aim of this manual is to make the
operators aware of the safety regulations,
installation procedures, instructions for proper
use and maintenance of the appliance and its
accessories.
Use of this manual for aims other than those
strictly linked to the installation, use and
maintenance of the appliance is prohibited.
The information and illustrations in this
manual were updated on the edition date
shown on the last page.
MECTRON is engaged in continuously
updating its products with possible changes
to the components of the apparatus.
In case you encounter discrepancies between
the descriptions found in this manual and the
equipment in your possession you can:
• check for any available updates in the
MANUALS section of the MECTRON
website
1
;
•
• contact MECTRON After Sales Service.
1.1 Intended Use
With the appropriate inserts it is possible to perform the following treatments:
• Scaling: all the procedures for the
removal of deposits of bacterial plaque
and supragingival, subgingivali and inter
dental stones, and removal of stains;
• Periodontics: periodontal therapy for
scaling and root-planing/debridement,
including cleaning and irrigation of the
periodontal pocket;
• Cleaningtreatmentoftheimplant
surface;
• Endodontics: all treatments for canal
percha condensation, endodontic
reprocessing and retrograde cavity
preparation;
• Restorativeandprosthesis:
preparation of the cavities and removal
of caries, removal of the prosthesis
and of restoration materials in excess,
of the prosthetic stump.
The Mectron piezoelectric ultrasonic scaler devices can be used on patients of any age and
population segments.
WARNING: The appliance must be used
in a dental practice or clinic, or in professional
oral hygiene and preventive care centres. Do
not use the device in environments where
gases (anaesthetic mixtures, oxygen, etc.).
WARNING: Qualiedandspecialised
sta.
The appliance is intended exclusively for
use by a dental surgeon, dentist, or dental
hygienist, with suitable medical/health
training.
2
COMPACT PIEZO P2K
WARNING: Intended use. Use the
appliance exclusively for the use for which it
is intended. Failure to observe this regulation
can cause serious injury to the patient, the
operator, and damage/failure of the device.
1.2 DescriptionoftheAppliance
COMPACT PIEZO P2K is a multi-purpose
piezoelectric ultrasonic scaler.
It is designed to equip the operator with a
product featuring an innovative design and
unique technical characteristics, and to ensure
utmost patient comfort during treatment
thanks to a broad scale of available power
levels.
The appliance is equipped with an automatic
tuning circuit that optimises power and
frequency for each insert available, in order
to always operate in conditions of maximum
1.2.1 EligiblePatientGroup
This medical device is designed to be used with the following patient groups:
• Children;
• Adolescents;
• Adults;
• Seniors.
This medical device can be used on patients
of any age, weight, height, gender, and
nationality, where applicable.
1.2.2 PatientSelectionCriteria
It is not recommended to use the device in the following cases:
1. Patients with active implantable
medical devices (for example:
pacemakers, hearing aids, and/or other
electromagnetic prostheses) without
prior authorisation from their doctor;
2. Patients with clinical conditions not
suitable for treatment of the sites (for
example: local anaesthesia).
All piezoelectric ultrasonic scaler device
models are intended for professional use only.
The user is therefore the only person able to
decide if and how to treat their patients.
1.2.3 IndicationsforUse
Use of the device is suitable for all eligible patients (see
Chapter 1.2.1 on page 2
) whose
doctor has prescribed professional scaling, periodontology, endodontic cleaning, implant site
surface cleaning, a restorative or prosthetic technique, as part of the intended use of the device
(see
Chapter 1.1 on page 1
).
3
INTRODUCTION
1.2.4 Users
the dental surgeon/dentist or dental hygienist, who must be able-bodied, adult, of any weight,
age, height, gender, and nationality.
1.3 Disclaimer
The manufacturer MECTRON disclaims all
liability, express or implied, and cannot be
held responsible for direct or indirect personal
injury and/or property damage, occurring as a
result of incorrect procedures linked to the use
of the appliance and its accessories.
The manufacturer MECTRON cannot be held
liable, expressly or implicitly, for any type of
personal injury and/or property damage,
accessories and which occurs in the following
cases, by way of example and not of limitation:
• Misuse or use during procedures other
use of the product;
• The environmental conditions for
preservation and storage of the device
are not complying with the requirements
indicated in
Chapter 9 on page 32
;
• The appliance is not used in
accordance with all the instructions and
requirements described in this manual;
• The electrical system of the places where
the equipment is used do not comply
with the laws in force and the related
regulations;
• Assembly operations, extensions, re-
adjustments, upgrades and repairs of the
device are carried out by personnel not
authorised by MECTRON;
• Misuse, abuse, abnormal use, negligent
use, intentional misconduct or use
exceeding the limits of the appliance
indicated and allowed and/or normal
wear or deterioration, ill-treatment and/
or incorrect interventions;
• Any attempt to tamper with or
every circumstance;
• Use of non original MECTRON inserts
resulting in permanent damage to the
thread of the handpiece with impaired
functioning and risk of injury to the
patient;
• Use of non original MECTRON inserts
used in accordance with the settings
designed and tested on the original
MECTRON inserts. Correct use of the
settings is only guaranteed with original
MECTRON inserts;
• Shortage of stock material (handpiece,
inserts, wrenches) to be used in case of a
standstill due to faults or problems;
• Incorrect/omitted maintenance
compared to what is stated in
on page 31
of this manual;
• Breach of the requirements and the
information contained in
Chapter 4.5 on
page 16
of this manual;
• Breach of the requirements and the
information contained in
Chapter 6 on
page 19
of this manual;
• Unauthorised repairs in accordance with
the indications contained in
Chapter 10.2
on page 42
this manual.
4
COMPACT PIEZO P2K
1.4 SafetyRequirements
WARNING: Contraindications.
Do not use the appliance on patients with
Pacemakers or other implantable electronic
devices. This regulation also stands for the
operator.
WARNING: Contraindications. Do not
perform scaling treatments without water
spray in order to avoid an overheating of the
insert that can cause damage to the tooth.
Treatments without water spray can only be
those performed with the "Dry Work" inserts
without water passage.
CAUTION: Contraindications.Ultrasonic
scaler. Do not perform treatments on metal
or ceramic prosthetics. Ultrasonic vibrations
could lead to decementation of the dentures.
WARNING: Contraindications.
Interferencefromotherequipment.
An electrosurgical scalpel or other
electrosurgical units positioned near the
COMPACT PIEZO P2K appliance may interfere
with the correct operation of the appliance
itself.
WARNING: Contraindications.
Interferencewithotherequipment. Even
if compliant with standard IEC 60601-1-2,
COMPACT PIEZO P2K may interfere with
other devices in the vicinity.
WARNING: Riskofexplosion. The
appliance cannot operate in environments
where the atmosphere is saturated with
etc.).
CAUTION
operating in their own medical room or
surgery, in order to comply with mandatory
requirements, must periodically inspect the
equipment present in the surgery, the test
procedures to apply to medical electrical
equipment and medical electrical systems for
the safety assessment must be carried out
following the standard EN 62353 'Medical
electrical equipment - Periodic inspections
and tests to be carried out after repair of
medical electrical equipment'. The 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 condition
CAUTION: The electrical system of the
premises in which the appliance is installed
and used must comply with the rules in force
and the relevant requirements of electrical
safety.
WARNING: Cleaningandsterilising
neworrepairedinstruments. All the new or
repaired appliance accessories are not sterile.
must be cleaned and sterilised by carefully
following the instructions in
Chapter 6 on
page 19
.
WARNING: Infectioncontrol.
For maximum patient and operator safety,
before using all the parts and reusable
accessories, make sure they have been
previously cleaned and sterilised by following
the instructions in
Chapter 6 on page 19
.
CAUTION: Contraindications. After
having autoclaved the handpiece, inserts,
torque wrench or any other sterilisable
accessory, wait for them to completely cool
down before reusing them.
5
INTRODUCTION
WARNING: InsertBreakageandWear.
High frequency oscillations and wear can, in
rare cases, lead to the breakage of the insert.
Deformed or damaged inserts are susceptible
to breakage during use. Broken or worn
inserts must not ever be used.
In the event of breakage check that no
fragments remain in the treated part and
remove them.
It is necessary to instruct the patient to
breathe through the nose during the
treatment, or use a dental dam, so as to avoid
to ingest fragments of broken inserts.
Check the state of wear of the insert and
its integrity before and during each use.
If a drop in performance occurs, see to its
replacement.
The state of wear of the most common
inserts (S1, S1-S, S2, S5, P2, P4, P10) can be
checked using the supplied INSERT-CARD. To
use the INSERT-CARD correctly:
• Position the insert on the INSERT-CARD
one printed on the card. The printed
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.
If the layer of titanium nitride (gold-plated
surface), where present, is visibly worn, the
insert must be replaced. The use of a worn
DiamondInserts: diamond inserts must be
replaced when the layer of titanium nitride is
visibly worn and in any case after a maximum
of 10 treatments.
When the nitriding is consumed, the
regrinding harms the insert, therefore it is
prohibited. Verify that the insert is not worn.
During the operation frequently check that
the insert is intact, especially in the apical
part.
During the operation avoid prolonged
contact with the retractor or with metal
instruments in use. Do not exert excessive
pressure on the inserts during use.
WARNING: Exclusivelyuseoriginal
MECTRONinserts,accessoriesandspare
parts.
CAUTION
this appliance.
WARNING: In case of an adverse event
and/or 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
COMPACT PIEZO P2K
1.5 Symbols
Symbol Description Symbol Description
0051
Device compliant
with Regulation (EU)
body: IMQ S.p.A.
Nemko brand
Compliance with UL -
CSA regulations
Medical device Caution! Read the
instructions for use
Operating instructions Manufacturer
Date of manufacture Serial number
Batch number Product code
Not sterile
The sterilisable
materials must be
autoclaved and can
resist up to a maximum
temperature of 135°C
“B” Part applied
according to regulation
EN 60601-1
Hazardous voltage
Alternating current Continuous current
Generic warning signal
a)
The appliance and its
accessories must not be
disposed of or treated
as municipal solid waste
Temperature limits for
transport and storage
Moisture limits for
transport and storage
Atmospheric pressure
limits for transport and
storage
Quantity in package: 1
IDENTIFICATION DATA
Symbol Description Symbol Description
Rx only
For US market only
CAUTION: US federal
law restricts sale to
orders by licensed
dentists or dental
hygienists only.
Table1 – Symbols a) The symbol is represented by a yellow triangle and
black graphic symbol.
2 IDENTIFICATIONDATA
A correct description of the model and of
the serial number of the appliance will allow
the After Sales Service to provide fast and
Always provide this information every time
that you contact MECTRON After Sales Service.
2.1 ScalerHandpieceIdenticationData
The handpiece name, MECTRON logo,
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 6
.
102000000
03120016
0051 YYYY-MM
YYYY-MM YYYY-MM
0051
0051
03120000
102000000
03120016
0051
102000000
03120016
YYYY-MM
SCALER
HANDPIECE
SCALER
ABLATORE
MANIPOLO
HANDPIECE
SCALER
HANDPIECE
Bar Code
HIBC 128
2.2 InsertsIdenticationData
The name of the insert itself (Reference
1), MECTRON logo (Reference 2), and
insert batch number (Reference 3) are
laser engraved on each insert.
1 2 3
8
COMPACT PIEZO P2K
3 DELIVERY
3.1 Listofcomponents
See
Figure 1 on page 11.
COMPACT PIEZO P2K is supplied with the
standard equipment (see Table 2 on page
8), a set of variable accessories depending
Table 3 on page 10), and accessories that
can be ordered separately (see Table 4 on
page 11).
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 02830084 B
Scaler Handpiece 03120016 SCALER HAND-PIECE C
Table2 – Standard supply.
Accessoriesavailablefororderwithstandardsupply
Item Code Description Ref.
Torque wrench
K10 torque wrench b) D
02900081 c) b)
Inserts 0296xxxx "S” series reusable scaler inserts b) E
0308xxxx “PE” series reusable scaler inserts
b)
0305xxxx “R” series reusable scaler inserts b)
0345xxxx “ER” series reusable scaler inserts
b)
0235xxxx “E” series reusable scaler inserts b)
0299xxxx “D” series reusable scaler inserts
b)
0219xxxx “CM” series reusable scaler
inserts b)
9
Accessoriesavailablefororderwithstandardsupply
Item Code Description Ref.
“ICS” series reusable base insert b)
03590009 "IC1" tip b)
02900112 IC1 tips kit (5 pcs.) b)
DB1 reusable base support for
inserts b)
03590001 TA12D60 diamond insert b)
03590004 TA12D90 diamond insert b)
03590002 TA14D60 diamond insert b)
03590005 TA14D90 diamond insert b)
TA14D120 diamond insert b)
03590003 TA16D60 diamond insert b)
03590006 TA16D90 diamond insert b)
03590008 TA16D120 diamond insert b)
03590010 TF12D60 diamond insert b)
03590011 TF16D60 diamond insert b)
03590012 TF12D90 diamond insert b)
03590013 TF16D90 diamond insert b)
10
COMPACT PIEZO P2K
Accessoriesavailablefororderwithstandardsupply
Item Code Description Ref.
Wiring
01560022 Layout A b) F
01560023 Layout B b)
01560024 Layout C b)
01560026 Layout D b)
Layout E b)
01560031 Layout F b)
01560101 Layout G b)
01560141 Layout H b)
Use and Maintenance Manual
IT version b)
G
EN version b)
DE version b)
FR version b)
ES version b)
Information: Online
Documentation 02150650
Installation Manual
IT version b)
G
02150180 EN version b)
02150181 DE version b)
02150182 FR version b)
02150183 ES version b)
Table3 – Accessories available for order with standard supply.
11
Accessoriesavailableforseparateorder
Item Code Description Ref.
Front cone without light b) H
Table4 – Accessories available for separate order.
b) Produced by Mectron. c) To be used only for the "Crown Preparation” kit.
The packaging of the appliance cannot
undergo strong impacts as contains electronic
components, therefore the transport and the
storage must be carried out with particular
care.
All the material sent by MECTRON was
controlled at the time of dispatch.
The appliance is shipped appropriately
protected and packaged.
Upon receipt of the appliance, check for any
possible damage caused during transport and
in case any damage and/or defects is found,
complain to the transporter.
Keep the packaging in case any items need to
be sent to an Authorised MECTRON Service
Centre and to store the appliance during long
periods of non-use.
WARNING: Before starting the treatment,
always make sure to have a stock of material
(handpiece, inserts, wrenches) to use in the
event of failures or drawbacks.
E F
D
A
G H
B C
Figure1 – List of components
12
COMPACT PIEZO P2K
4 USE
4.1 Controls
For the description of the controls and warnings, see the manual supplied by the manufacturer
of the dental unit.
4.2 PowerOn/O
dental unit.
4.3 SafetyRequirementsBeforeandDuringUse
WARNING: Before starting work always
ensure that you have all replacement parts
(handpiece, inserts, keys) to use should there
be downtime due to a fault or problem.
WARNING: Exclusivelyuseoriginal
Mectroninserts,accessoriesand
replacementparts.
WARNING: Useofnon-original
insertsnotproducedbyMECTRON: this
entails permanent damage to the thread
of the handpiece and compromises correct
operation with the risk of causing harm to the
patient.
CAUTION: Contraindications-
UltrasonicScaler. Do not perform treatments
on metal or ceramic prosthetics. Ultrasonic
vibrations could lead to decementation of the
dentures.
WARNING: Contraindications. Do not
use COMPACT PIEZO P2K on patients with
Pacemakers or other implantable electronic
devices. This regulation also stands for the
operator.
WARNING: Do not perform scaling
treatments without water spray in order
to avoid an overheating of the insert that
can cause damage to the tooth. Treatments
without water spray can only be those
performed with the "Dry Work" inserts
without water passage.
CAUTION: In treatments requiring
irrigation, use only inserts with a liquid
passage.
WARNING: Treatmentsthatrequire
irrigation. Always check the operation of the
irrigation before and during use. Make sure
that the liquid exits from the insert.
Do not use the appliance if the irrigation
does not work.
WARNING: Infectioncontrol.First
use: All parts and reusable accessories (new
or returned from an Authorised MECTRON
Service Centre) are delivered in NON-STERILE
conditions and must be treated before each
use, according to the instructions provided in
Chapter 6 on page 19
. Subsequentuses:
After each treatment, clean and sterilise all
parts and reusable accessories according to
the instructions in
Chapter 6 on page 19
.
CAUTION: For correct use of the
appliance, the pedal must be pressed and
the appliance started with the insert not in
contact with the part to be treated, so that
the electronic circuit is able to recognise
the best point of resonance of the insert
without interference, thus allowing optimum
performance.
WARNING: Before each treatment
ensure that the insert that is suitable for the
treatment is inserted on the handpiece.
Use only the Mectron torque wrench to
secure the insert to the handpiece.
WARNING: Do not change the insert
whilst the handpiece is in operation in order
to avoid causing injury to the operator.
13
USE
WARNING: InsertBreakageandWear.
High frequency oscillations and wear can, in
rare cases, lead to the breakage of the insert.
Deformed or damaged inserts are susceptible
to breakage during use. Broken or worn
inserts must not ever be used.
In the event of breakage check that no
fragments remain in the treated part and
remove them.
It is necessary to instruct the patient to
breathe through the nose during the
treatment, or use a dental dam, so as to avoid
to ingest fragments of broken inserts.
Check the state of wear of the insert and
its integrity before and during each use.
If a drop in performance occurs, see to its
replacement.
The state of wear of the most common
inserts (S1, S1-S, S2, S5, P2, P4, P10) can be
checked using the supplied INSERT-CARD. To
use the INSERT-CARD correctly:
• Position the insert on the INSERT-CARD
one printed on the card. The printed
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.
If the layer of titanium nitride (gold-plated
surface), where present, is visibly worn, the
insert must be replaced. The use of a worn
DiamondInserts: diamond inserts must be
replaced when the layer of titanium nitride is
visibly worn and in any case after a maximum
of 10 treatments.
When the nitriding is consumed, the
regrinding harms the insert, therefore it is
prohibited. Verify that the insert is not worn.
During the operation frequently check that
the insert is intact, especially in the apical
part.
During the operation avoid prolonged
contact with the retractor or with metal
instruments in use. Do not exert excessive
pressure on the inserts during use.
CAUTION: Contraindications. After
autoclaving the handpiece, the inserts, the
torque wrench, or any other sterilisable
accessory, wait until it has completely cooled
before reuse.
CAUTION: Theelectricalcontacts
insidetheconnectorsonthehandpiece
andcordmustbedry. Before connecting
the handpiece to its cord, make sure that the
electrical contacts of the connector on both
sides are perfectly dry, especially after the
sterilisation cycle in an autoclave. If necessary
dry the contacts by blowing them with
compressed air.
CAUTION: Owing to its conformation,
the handpiece can rotate. When not used the
handpiece must always be put back on its
support stand.
WARNING: During the intervention on
the patient, do not perform any maintenance
tasks on the system.
WARNING: Infectioncontrol.After
prolonged non-use of the dental unit, run a
water circuit cleaning cycle as indicated in the
user manual supplied by the manufacturer of
the dental unit.
14
COMPACT PIEZO P2K
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.
Check that the electrical contacts of both
are perfectly dry and if necessary dry
them by blowing with compressed air.
1
Screw in the preselected insert on the
scaler handpiece until it comes into
contact
2
Place the insert inside the MECTRON
3
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