mectron compact piezo P2K User manual

0051
INSTALLATION 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 5
2 IdenticationData 6
2.1 Appliance ID Plate 6
2.2 ScalerHandpieceIdenticationData 7
2.3 InsertsIdenticationData 7
3 Delivery 8
3.1 List of Components 8
4 Installation 12
4.1 Safety Requirements During Installation 12
4.2 Mechanical Installation 13
4.3 Electrical Connections 13
4.3.1 Alternate 24V Power Supply 15
4.3.2 Direct 32V Power Supply 15
4.3.3 Power Regulation 15
4.3.3.1 Power Regulation with 2.2 kOhm Potentiometer 15
4.3.3.2 Power Regulation with 10 kOhm Potentiometer 16
4.3.3.3 PowerRegulationwith4.7kOhmPotentiometer 16
4.3.3.4 0-5 V Power Regulation 16
4.3.3.5 0-10VPowerRegulation 17
4.3.4 SolenoidValveControl 17
4.3.5 Enabling 17
4.3.5.1 EnablingofPedalwithNegativeSignal 17
4.3.5.2 Enabling of Pedal with Positive Signal 18
4.3.6 Other Connections 18
4.3.7 ConnectingtheCordoftheScalerHandpiece 19
4.3.8 StandardConnections 19
4.3.8.1 Layout A 20
4.3.8.2 Layout B 20
4.3.8.3 Layout C 21
4.3.8.4 Layout D 21
4.3.8.5 Layout E 22
4.3.8.6 Layout F 22
4.3.8.7 LayoutG 23
4.3.8.8 Layout H 23
4.4 Water Connection 24
5 Diagnostics 25
5.1 Description of Diagnostic Warnings 25
5.1.1 Appliance Powered Without Pedal Consent 25
5.1.2 Appliance Powered With Pedal Consent 25
6 MethodsandPrecautionsforDisposal 26
7 TechnicalData 27

III
7.1 ElectromagneticCompatibilityIEC/EN60601-1-2 28
7.1.1 GuideandManufacturer’sDeclaration-ElectromagneticEmissions 28
7.1.2 AccessiblePartsoftheCasing 29
7.1.3 GuideandtheManufacturer'sDeclaration-ElectromagneticImmunity 30
7.1.3.1 PowerConnectionBCInput 30
7.1.3.2 PointsofContactwiththePatient 32
7.1.3.3 PartsAccessibletotheInput/OutputSignals 33
7.1.4 SpecicationsoftheTestsfortheImmunityoftheAccessiblePartsofthe
Casing to the Wireless RF Communications Device 34
8 Troubleshooting 35
8.1 Quick Troubleshooting 35
8.2 ShippingtoanAuthorisedMectronServiceCentre 37
9 Warranty 38

IV
COMPACT PIEZO P2K
PAGELEFTINTENTIONALLYBLANK

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
requirementsareclassiedwiththefollowing
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 and
installation procedures 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
;
• askclaricationstoYourDealer;
• 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;
• Cleaningtreatmentoftheimplant
surface;
• Endodontics: all treatments for canal
preparation,irrigation,lling,gutta-
percha condensation, endodontic
reprocessing and retrograde cavity
preparation;
• Restorativeandprosthesis:
preparation of the cavities and removal
of caries, removal of the prosthesis
and of restoration materials in excess,
condensationoftheamalgam,nishing
of the prosthetic stump.
The Mectron piezoelectric ultrasonic scaler devices can be used on patients of any age and
gender requiring a tooth polishing treatment. There are no contraindications for specic
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
theatmosphereissaturatedwithammable
gases (anaesthetic mixtures, oxygen, etc.).
WARNING: Qualiedandspecialised
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 DescriptionoftheAppliance
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
eciency.
1.2.1 EligiblePatientGroup
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 PatientSelectionCriteria
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 IndicationsforUse
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devicemustbeusedexclusivelybyspecialisedandproperlytrainedpersonnel,specically
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,
inicted by the user of the product and its
accessories and which occurs in the following
cases, by way of example and not of limitation:
• Misuse or use during procedures other
thanthosespeciedinthedestinationof
use of the product;
• The environmental conditions for
preservation and storage of the device
are not complying with the requirements
indicated in Chapter7onpage27 ;
• 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
modicationoftheapplianceunder
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 Chapter 5
on page 25 of this manual;
• Breach of the requirements and the
information contained in Chapter 4.5 on
page 16 of the Use and Maintenance
Manual;
• Breach of the requirements and the
information contained in Chapter 6 on
page 19 of the Use and Maintenance
Manual;
• Unauthorised repairs in accordance with
the indications contained in Chapter 8.2
on page 37 this manual.

4
COMPACT PIEZO P2K
1.4 SafetyRequirements
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.
Interferencefromotherequipment.
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.
Interferencewithotherequipment. Even
if compliant with standard IEC 60601-1-2,
COMPACT PIEZO P2K may interfere with
other devices in the vicinity.
WARNING: Riskofexplosion. The
appliance cannot operate in environments
where the atmosphere is saturated with
ammablegases(aestheticmixtures,oxygen,
etc.).
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.
CAUTION:Nomodicationisallowedto
this appliance.
CAUTION:Incasethenaluser,
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 the “Use and
Maintenance” manual is once per year or
every 2000 hours of use, whichever condition
issatisedrst.
WARNING: Cleaningandsterilising
neworrepairedinstruments. All the new or
repaired appliance accessories are not sterile.
Atrstuseandaftereachtreatmentthey
must be cleaned and sterilised by carefully
following the instructions in Chapter 6 on
page 19 of the Use and Maintenance
Manual.
WARNING: Infectioncontrol.
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 of
the Use and Maintenance Manual.
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.
WARNING: Exclusivelyuseoriginal
MECTRONinserts,accessoriesandspare
parts.
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.

5
INTRODUCTION
1.5 Symbols
Symbol Description Symbol Description
0051
Device compliant
with Regulation (EU)
2017/745.Notied
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
QTY.1 Quantity in package: 1

6
COMPACT PIEZO P2K
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.
Table1 – Symbols a) The symbol is represented by a yellow triangle and
black graphic symbol.
2 IDENTIFICATIONDATA
A correct description of the model and of
the serial number of the appliance will allow
the After Sales Service to provide fast and
eectiveanswers.
Always provide this information every time
that you contact MECTRON After Sales Service.
2.1 ApplianceIDPlate
Each appliance is equipped with an
identication plate indicating the main
technical characteristics and serial
number. The ID plate is located on the
side of the COMPACT PIEZO P2K module.
Thecompletetechnicalspecicationsare
provided in Chapter7onpage27 .
NOTE: The complete list of symbols is
provided in Chapter 1.5 on page 5 .
COMPACT PIEZO P2K
034000000madein Italy
manufacturer
Mectron S.p.A.
Via Loreto 15/a
16042 Carasco -GE- Italy
0051
04000079YYYY-MM-DD
24V 50/60 Hz / 32V Min. 40 VA
Bar Code HIBC 128
Additional symbols and characteristics
of the device are provided on a separate
plate. This ID plate is located on the side
of the COMPACT PIEZO P2K module.
NOTE: The complete list of symbols is
provided in Chapter 1.5 on page 5 .
Proteggere con Fusibile T 2AL, 250V
Utilizzare solo con adattatori o simili indicati nel
manuale di istruzioni
Apparecchio per funzionamento intermittente:
60 s ON - 30 s OFF con irrigazione
30 s ON - 120 s OFF senza irrigazione
COMPACT PIEZO P2K

7
IDENTIFICATION DATA
2.2 ScalerHandpieceIdenticationData
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 5 .
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
2.3 InsertsIdenticationData
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 ListofComponents
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
onthecongurationandclientrequests(see
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.
Standardsupply
Item Code Description Ref.
Device core unit 04000079 A
Cord 02830084 B
Scaler Handpiece 03120016 SCALER HAND-PIECE C
Table2 – Standard supply.
Accessoriesavailablefororderwithstandardsupply
Item Code Description Ref.
Torque wrench
02900137 K10 torque wrench b) D
02900081 K7torquewrench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
DELIVERY
Accessoriesavailablefororderwithstandardsupply
Item Code Description Ref.
03570004 “ICS” series reusable base insert b)
03590009 "IC1" tip b)
02900112 IC1 tips kit (5 pcs.) b)
03570001 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)
03590007 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
Accessoriesavailablefororderwithstandardsupply
Item Code Description Ref.
Wiring
01560022 Layout A b) F
01560023 Layout B b)
01560024 Layout C b)
01560026 Layout D b)
01560027 Layout E b)
01560031 Layout F b)
01560101 Layout G b)
01560141 Layout H b)
Use and Maintenance Manual
02150174 IT version b)
G
02150175 EN version b)
02150176 DE version b)
02150177 FR version b)
02150178 ES version b)
Information: Online
Documentation 02150650
Installation Manual
02150179 IT version b)
G
02150180 EN version b)
02150181 DE version b)
02150182 FR version b)
02150183 ES version b)
Table3 – Accessories available for order with standard supply.

11
DELIVERY
Accessoriesavailableforseparateorder
Item Code Description Ref.
Front cone without light 03020171 b) H
Table4 – 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
Figure1 – List of components

12
COMPACT PIEZO P2K
4 INSTALLATION
COMPACT PIEZO P2K, in order to operate
must be connected to a dental unit.
The dental unit mechanically houses the pilot
module, supplies power to the module, and
supplies water to cool the handpieces and
inserts.
The dental unit to which COMPACT PIEZO P2K
is connected must be a medical device that
complies with general and applicable product
regulationsforthespeciccategoryofdental
unit, and in general, satisfy the following
standards:
• ISO7494Dentistry–Stationarydental
units and dental patient chairs;
• ISO 60601-1 Medical electrical
equipment–Part1:General
requirements for basic safety and
essential performance.
CAUTION:Check that the dental unit to
which COMPACT PIEZO P2K is connected
satisesthespeciedrequirements.
4.1 SafetyRequirementsDuringInstallation
WARNING: Riskofexplosion.
The appliance cannot operate in
environments where there are saturated
atmospheresofammablegases(aesthetic
mixtures, oxygen, etc.).
WARNING: Install the appliance in a safe
place protected from impact or accidental
water or liquid spray.
WARNING: Do not install the appliance
above or near sources of heat. Arrange
during installation for a suitable circulation of
air around the appliance.
CAUTION: The water hose of the scaler
handpiece cord must be directly connected
to the dental unit cold water circuit.
CAUTION: The voltage of the power
supply line to which the appliance is
connected must be compatible with the
technicalspecications(see Chapter7on
page 27) and envisaged connection layout.
CAUTION: For the correct power supply,
useapoweradaptercompliantwithIEC/EN
60601-1 having the following characteristics:
• 24V~50/60Hzor
• 32 V with minimum power 40VA.
CAUTION: Do not invert the position on
the connector of the red wire and black wire
of the scaler handpiece cord (see Figure 4 on
page19).
CAUTION: Do not wire the red and black
wires of the scaler handpiece cord (see Figure
4onpage19) together with other cables.
CAUTION: If long connections are
required for the power supply, use wires with
a suitable wire gauge, for example 1.5 mm2.
CAUTION: It is prohibited to make any
changes to this appliance.
WARNING: The installer or
manufacturer of the dental unit on which
the COMPACT PIEZO P2K module has been
installed is responsible for ensuring the
product and entire system remain compliant
withIEC/EN60601-1inforce”.
CAUTION: Before connecting the
handpiece to its cord, check that the electrical
contacts are perfectly dry, on both parts. If
necessary dry them with compressed air.

13
INSTALLATION
4.2 MechanicalInstallation
Figure 2 on page 13 shows the dimensions of the module.
The module can be secured to the dental unit by means of two M3 threaded holes (Ref. A and
B), or alternatively, by means of two holes with diameter 2 mm (Ref. C and D).
WARNING: The M3 screw used to secure
the module must not penetrate the inside of
said module for more than 4mm as it may
damage the circuits.
The holes with diameter 2 mm have a
maximum depth of 6 mm.
The module is also supplied with holes on the
sides, but these must NOT be used to secure
it. The holes on the sides are used to attach
several internal components.
5,0012,00
70,00
36,50
46,00
2,00
2,00
42,00
M3
M3
23,00
34,00
A
A
B
B
C
C
D
D
MAX
4,00
M3
MAX
6,00
2,00 2,00
Figure2 – Dimensions of the module.
4.3 ElectricalConnections
COMPACT PIEZO P2K allows various electrical
congurationstosatisfythecharacteristicsof
the dental unit in which it is housed.
The dental units to which the
COMPACT PIEZO P2K device can be connected
must be able to provide one of the following
power supplies:
• 24V~50/60Hzor
• 32 V
with minimum power 40VA.
Moreover, it must have a 2A, 250V safety fuse.
For the electrical connections, the
COMPACT PIEZO P2K device is equipped with
2 connectors (see Figure 3 on page 14):
• M1 : connector with 2x8 contacts for the
module controls;
• M2 : connector with 2 contacts for
connection of the handpiece cable
(piezoelectric elements control).

14
COMPACT PIEZO P2K
M1M2
M1
M2
1 21 2 3 4 5 6 7 8
16 15 14 13 12 11 10 9
Figure3 – Module connectors.
M1ConnectorPin-Out
Pin Signal Pin Signal
1 Reserved 9Bypass capacity
2 RIS 10 GND
3TX 11 Pedal +
4 RX 12 Power Selection
5 Valve 13 AC In
6 Power Control 14 AC/DCIn
7Pedal - 15 GND
8 +Vdc 16 Reserved
Table5 – M1 Connector Pin-Out.
M2ConnectorPin-Out
Pin Signal
1 Vout handpiece
2 Neutral
Table6 – M2 Connector Pin-Out.