mectron Piezosurgery II Instruction manual

MANUAL OF USE AND MAINTENANCE
0476
II
English

2 / 32 Piezosurgery // GB
MANUAL OF USE AND MAINTENANCE
Summary
00.0 - INTRODUCTION ............................................................................................................................... 3
00.1 - Foreword ...................................................................................................................................... 3
00.2 - Description of the Device ............................................................................................................. 3
00.3 - Intended Use................................................................................................................................ 4
00.4 - Safety requirements ..................................................................................................................... 4
01.0 - IDENTIFITION DATA ........................................................................................................................ 6
01.1 - Identification data......................................................................................................................... 6
01.2 - Data Plate of the Device .............................................................................................................. 6
01.3 - Data Plate of the Scaler Handpiece.............................................................................................. 6
02.0 - TESTING .......................................................................................................................................... 7
02.1 - Testing of the equipment .............................................................................................................. 7
03.0 - DELIVERY ........................................................................................................................................ 7
03.1 - Delivery of the apparatus ............................................................................................................. 7
03.2 - List of Materials included in the Standard Supply ......................................................................... 8
04.0 - INSTALLATION ................................................................................................................................ 8
04.1 - Safety Requirements during Installation ....................................................................................... 8
04.2 - Initial Installation ........................................................................................................................ 10
04.3 - Connecting the Accessories....................................................................................................... 10
05.0 - USE ................................................................................................................................................ 13
05.1 - Controls ..................................................................................................................................... 13
05.2 - Switching the Device ON and OFF ............................................................................................. 13
05.3 - Description of the Display and Functions ................................................................................... 14
05.4 - Safety Requirements during Use ................................................................................................ 16
05.5 - Protection Systems and Alarms ................................................................................................. 17
05.6 - Instructions for Use .................................................................................................................... 18
05.7 - Rules for Keeping the Device in Proper Working Order ............................................................... 18
06.0 - CLEANING, DISINFECTION AND STERILISATION ....................................................................... 19
06.1 - CLEAN function – Cleaning of the liquid circuit ..........................................................................19
06.2 - Cleaning and disinfecting the casing of the apparatus ................................................................ 19
06.3 - Sterilisation procedure ................................................................................................................ 20
06.4 - Autoclave sterilisation of the handpiece ..................................................................................... 20
06.5 - Autoclave sterilisation of the inserts .......................................................................................... 21
06.6 - Autoclave sterilisation of the wrench for tightening the inserts ................................................... 21
06.7 - Autoclave sterilisation of the peristaltic pump tube .................................................................... 22
06.8 - Autoclave sterilisation of the connection between cord and peristaltic pump tube connection .... 22
07.0 - REGULAR MAINTENANCE ............................................................................................................ 23
07.1 - Shelf Storage ............................................................................................................................. 23
07.2 - Power-supply Cable ................................................................................................................... 23
08.0 - REPLACEMENT OF THE FUSES .................................................................................................. 23
09.0 - PROCEDURES AND PRECAUTIONS FOR DISPOSAL ................................................................. 24
10.0 - THE INSERTS ................................................................................................................................ 24
11.0 - SYMBOLS ...................................................................................................................................... 25
12.0 - TROUBLESHOOTING .................................................................................................................... 26
13.0 - TECHNICAL DATA ......................................................................................................................... 29
14.0 - GUARANTEE.................................................................................................................................. 31

Piezosurgery // GB 3 / 32
MANUAL OF USE AND MAINTENANCE
00.0 - INTRODUCTION
00.1 - Foreword
Before proceeding with the installation, use, maintenance or any other activities on
the equipment please read this manual carefully.
Always keep this manual within easy reach.
Important: To avoid causing personal injuries or damage to property, read all the points
concerning “Safety requirements” contained in this manual with particular
attention.
Depending on the level of risk involved, safety requirements are classed under the follow-
ing indications:
DANGER (always referred to personal injury)
WARNING (referred to possible damage to property)
The purpose of this manual is to ensure that operators are aware of the safety require-
ments, of the installation procedures and of the instructions for correct use and mainte-
nance of the apparatus.
The user is not authorised to tamper with the equipment under any circumstances.
If any problems are encountered, please contact a Mectron Service Centre.
Any attempts on the part of the user or any unauthorised personnel to tamper with or alter
the apparatus will invalidate the warranty and release the Manufacturers from any liability
in respect of any harm or damage to persons or property.
The information and illustrations contained in this manual are up-dated to the date of
publication indicated on page 32.
MECTRON are committed to continuous up-dating of their products, which may entail
changes to components of the equipment. If there are any discrepancies between the
descriptions contained in this manual and your equipment, please contact your dealer or
the MECTRON After-Sale service for explanations.
Using this manual for purposes other than those relating to the installation, use and main-
tenance of the equipment is strictly prohibited.
00.2 - Description of the Device
Thanks to its controlled three-dimensional ultrasound oscillations, the original Piezosurgery
technique rings in a new age for osteotomy and osteoplasty in Implantology, Periodontol-
ogy, Endodontics and Orthodontic Surgery. Its main features are:
- Micrometric cutting: Maximum surgical precision and intra-operative sensibility;
- Selective cutting: Maximum safety for the soft tissues;
- Cavitation effect: Maximum intra-operative visibility (bloodless field).
The equipment has an automatic tuning circuit that offsets wear of the inserts, thus ensur-
ing work in constant conditions of maximum efficiency.

4 / 32 Piezosurgery // GB
MANUAL OF USE AND MAINTENANCE
00.3 - Intended Use
The Piezosurgery is a piezoelectric device for bone surgery that enables osteotomy and
osteoplasty techniques to be applied to in almost any anatomical situation. This equip-
ment can be used in the following fields:
- Oral Surgery:
Extraction - Apicectomy - Cystectomy - Osteogenic distraction.
- Implantology:
Bone window osteotomy - Crest expansion - Bone fragment removal - Monocortical
bone removal - Osteoplasty - Final preparation of the implant site - Extraction for im-
mediate implantation - Elevation of Schneider’s membrane.
- Periodontal Surgery:
Osteotomy and osteoplasty techniques - Removal of bone tissues in regeneration sur-
gery - Root debridement - Root planing.
- Surgical Orthodontics:
Exposure or extraction of embedded teeth - Orthodontic corticotomy.
This equipment may be used only in a dentist’s surgery or out-patient’s department where
there are no inflammable gases (anaesthetic mixtures, oxygen, etc.).
00.4 - Safety requirements
Mectron will not accept any liability for direct or incidental personal injury or damage to
property in the following cases:
1 If the equipment is used for purposes other than that for which it is intended.
2 If the equipment is not used in accordance with all the instructions and requirements
described in this manual.
3 If the wiring system in the room where the equipment is used does not comply with the
applicable standards and appropriate requirements.
4 If any assembly operations, extensions, settings, alterations or repairs have been car-
ried out by personnel not authorised by Mectron.
5 If the environmental conditions in which the device is kept and stored do not comply
with the requirements indicated in the chapter on technical specifications.
DANGER: Qualified and specialised personnel.
This equipment may be used only by specialised and suitably trained personnel such as
surgeons. If correctly used, this equipment does not give rise to side effects. Improper
use, on the other hand, will give rise to transmission of heat to the tissues.
DANGER: Intended use.
Use the equipment solely for the purpose for which it is intended (see point “00.3”). Failure
to comply with this requirement could lead to serious harm to the patient and/or to the
operator and/or damage to/failure of the equipment.
DANGER: Contraindications.
Do not use the Piezosurgery on patients with pace-makers or other implantable electronic
devices. The same requirement applies also to the operator.

Piezosurgery // GB 5 / 32
MANUAL OF USE AND MAINTENANCE
DANGER: Contraindications.
An electrosurgical knife could interfere with correct functioning of the device.
DANGER: Cleaning, disinfection and sterilisation of new or repaired products.
All new or repaired products are delivered in non sterile conditions. Before being used for
treatments, all new or repaired products should be cleaned, disinfected and sterilised
following the instructions provided under point “06.0” strictly.
DANGER: Infection control.
In order to ensure maximum safety for both the patient and the operator, use only acces-
sories that have been cleaned, disinfected and sterilised. Follow the instructions provided
under point “06.0” closely.
DANGER: Use only original Mectron accessories and spare parts.
DANGER: Check the condition of the device before treatment.
Always make sure that there is no water under the apparatus. Before each treatment
always check that the equipment is in proper working order and that the accessories are
efficient. Do not carry out the treatment if any problems are encountered in operating the
device. If the problems concern the equipment contact an authorised technical service
centre.
DANGER: Breakage and wear of the Inserts.
The high-frequency vibrations and wear may, very occasionally, lead to breakage of the
insert. Inserts of which the shape has been changed or which are otherwise damaged are
liable to break during use. Any such inserts should definitely not be used. It is necessary
to instruct the patient to breathe through his nose during the treatment in order to avoid
ingestion of the broken off fragment of the insert.
DANGER: Do not install the equipment anywhere where there is a risk of explo-
sions.
The equipment cannot function in places where there is an inflammable atmosphere (an-
aesthetic mixtures, oxygen, etc.).
DANGER: Personal injury.
The footswitch of the Piezosurgery must not be activated with the door of the peristaltic
pump open (Fig.4 - Ref.B). Moving parts could injure the operator.
WARNING: Contraindication.
Do not carry out this treatment on metal or ceramic prosthetic artefacts. The ultrasonic
vibrations could lead to decementing of such artefacts.
WARNING: Contraindication.
After autoclave sterilising of the handpiece, wait for it to cool down completely before
using it.

6 / 32 Piezosurgery // GB
MANUAL OF USE AND MAINTENANCE
01.0 - IDENTIFITION DATA
01.1 - Identification data
An exact description of the model including the serial number of the equipment will make
it easier for our After-Sale Service to respond quickly and efficiently to your queries.
Always provide the above information whenever you contact a Mectron Service Centre.
01.2 - Data Plate of the Device
Each device has its own data plate (Fig.1), on which its technical specifications and serial
number are indicated. The data plate is on the rear of the device. The remaining data are
included in this manual (see Section “13.0”).
01.3 - Data Plate of the Scaler Handpiece
The serial number of this Piezosurgery handpiece is engraved on the ringnut (Fig.2 -
Ref.A).
Fig. 2
A
Fig. 1

Piezosurgery // GB 7 / 32
MANUAL OF USE AND MAINTENANCE
02.0 - TESTING
02.1 - Testing of the equipment
All equipment manufactured by MECTRON is thoroughly checked and tested, including
all components.
During the testing procedure the components are subjected to a number of work cycles.
The tests highlight any malfunctioning due to faulty components.
This procedure ensures proper functioning and reliability of all components.
03.0 - DELIVERY
03.1 - Delivery of the apparatus
The equipment contains electronic components that may be damaged by impacts even
inside the packaging. Special care must therefore be taken for both transport and storage.
In order to avoid crushing, do not place cartons on top of one.
All material shipped by MECTRON is checked at the time of shipment.
The equipment is delivered properly protected and packaged.
At the time of receipt of the equipment check it for possible transport damage. If any
damage is found, make a complaint to the carrier.

8 / 32 Piezosurgery // GB
MANUAL OF USE AND MAINTENANCE
03.2 - List of Materials included in the Standard Supply
1 Casing of the device (Fig.3 - Ref.B).
2 Piezosurgery handpieces complete with cords (Fig.3 - Ref.E).
2 K4 torque wrenches K4 (Fig.3 - Ref.D).
1 Footswitch with cable and plug (Fig.3 - Ref.G).
2 Connections for the cord and tube of the peristaltic pump (Fig.3 - Ref.F).
2 Drip system (Fig.3 - Ref.O).
1 Power-supply cable (Fig.3 - Ref.L).
8 Tube for the Piezosurgery peristaltic pump (Fig.3 - Ref.N).
1 Rod for supporting the bag (Fig.3 - Ref.Q).
1 Support for the Piezosurgery handpiece (Fig.3 - Ref.P).
1 Basic Insert Kit (Fig.3 - Ref.H) consisting of 5 inserts (Fig.3 - Ref.C).
1 Sinus Lift Insert Kit (Fig.3 - Ref.I) consisting of 5 inserts (Fig.3 - Ref.C).
1 Surgical Tray - Container for accessories to be sterilised (Fig.3 - Ref.M).
The items listed may vary during promotional campaigns.
WARNING: Handpiece and cord can’t be detached.
04.0 - INSTALLATION
04.1 - Safety Requirements during Installation
DANGER: The wiring system of the premises where the apparatus is installed and
used must comply with the applicable standards and the relevant electrical safety require-
ments.
DANGER: Do not install the apparatus in places where there is a risk of explosion.
The apparatus may not be used in areas where there are inflammable atmospheres (an-
aesthetic mixtures, oxygen, etc.).
DANGER: Install the apparatus in a place where it will be protected from blows and
from accidental sprays of water or other liquids.
DANGER: Do not install the device on or in the vicinity of sources of heat. Install it in
such a way that there is an adequate circulation of air around it. Leave sufficient free
space around it, in particular with reference to the fan on the rear (Fig.5 - Ref.G).
DANGER: Personal injury.
The footswitch of the Piezosurgery must not be activated when the door of the peristaltic
pump is open (Fig.4 - Ref.B). Moving parts could cause personal injury of the operator.
WARNING: Do not expose the apparatus to direct sunlight or to sources of UV light.
WARNING: The apparatus is transportable, however it must be handled with care
when it is moved. Position the pedal on the floor in such a way that it can only be activated
intentionally by the operator.

Piezosurgery // GB 9 / 32
MANUAL OF USE AND MAINTENANCE
A
B
C
D
E
F
G
H
I
L
M
N
O
P
Q
Fig. 3

10 / 32 Piezosurgery // GB
MANUAL OF USE AND MAINTENANCE
WARNING: Before connecting the cord to the device, make sure that the electrical
contacts are perfectly dry. If necessary, dry them with the air syringe.
04.2 - Initial Installation
To ensure perfect operation of the equipment, it is installed by technical personnel author-
ised by Mectron. The equipment will be installed in a suitable and handy place for it to be
used, and is enabled by entering an activating password.
The activating password is given to the technician responsible for installation and is not
indicated inside the package containing the device. The purpose of this is to ensure im-
mediate traceability of the device, as required according to current legislation.
The technician must:
- Install the device in a suitable place;
- Explain the main aspects of correct installation to the user;
- Fill in the installation form, including the purchaser’s data;
- Send the installation form to Mectron to ensure traceability and activation of the war-
ranty;
- Enter the activating password to enable the device.
04.3 - Connecting the Accessories
The accessories listed below have to be connected to the Piezosurgery device:
1 Insert the silicone tube into the peristaltic pump, proceeding as follows:
- Open the door (Fig.4 - Ref.A) as far as it will go (Fig.4 - Ref.B).
- Position the tube in the impeller (Fig.4 - Ref.C).
- Close the door completely (Fig.4 - Ref.E).
DANGER: Personal injury.
The footswitch of the Piezosurgery must not be activated when the door of the peristaltic
pump is open (Fig.4 - Ref.B). Moving parts could cause personal injury of the operator
2 Insert the rod for supporting the bag into the hole provided for it (Fig.5 - Ref.E).
3 Insert the handpiece support into the two holes provided for it (Fig.5 - Ref.C).
4 Connect the footswitch to the casing of the device by inserting the plug into the footswitch
socket (Fig.5 - Ref.H).
5 Plug the power cable into the connector on the casing of the device (Fig.5 - Ref.I) and
then into the power outlet.
6 Connect the Piezosurgery cord to the cord connector on the device (Fig.5 - Ref.D).
7 Insert the tube of the Piezosurgery into the pump fitting (Fig.5 - Ref.N). Insert the pump
fitting into the tube of the peristaltic pump (Fig.5 - Ref.M).
8 Connect end of the tube of the peristaltic pump (Fig.5 - Ref.L) to the flow-control sys-
tem.
9 Connect the flow-control system to the bag containing the appropriate liquid for the
treatment.