mectron Piezosurgery User manual

CLEANING AND STERILISATION MANUAL
REINIGUNGS- UND STERILISATIONSANLEITUNG
MANUALE DI PULIZIA E STERILIZZAZIONE
MANUEL DE NETTOYAGE ET DE STÉRILISATION
MANUAL DE LIMPIEZA Y ESTERILIZACIÓN
0051
Touch / White Line and Reusable Inserts

CLEANING AND STERILIZATION MANUAL
Touch / White Line and Reusable Inserts

I
Copyright
© Mectron S.p.A. 2021. All rights reserved. No part of this document can be reproduced in any
form without the written consent of the copyright owner.

II
SUMMARY
1 Introduction 1
2 Clean/Flush Function 2
2.1 Preparation 2
2.2 PIEZOSURGERY®touch 3
2.3 PIEZOSURGERY®white 4
2.4 Perform the Cleaning Cycle 5
3 Disassembling of Parts 5
4 Cleaning and Sterilization 9
4.1 Cleaning of the Console and of the Foot Pedal 10
4.1.1 Preparation 10
4.1.2 Materials Required 10
4.1.3 Cleaning Method 11
4.2 Cleaning of Accessories 12
4.2.1 Preparation 12
4.2.2 Pre-Cleaning 13
4.2.2.1 Materials Required 13
4.2.2.2 Preparation 13
4.2.2.3 Handpiece with Cord 14
4.2.2.4 Inserts 15
4.2.2.5 Inserts Torque Wrench 16
4.2.2.6 Peristaltic Pump Tubes and Mobile Handpiece Support 17
4.2.2.7 Tube-to-Tube Connector 18
4.2.2.8 Irrigation Bag Support Rod and Fixed Handpiece Support 19
4.2.3 Manual Cleaning 20
4.2.3.1 Materials Required 20
4.2.3.2 Preparation 20
4.2.3.3 Handpiece with Cord 20
4.2.3.4 Inserts 21
4.2.3.5 Inserts Torque Wrench 24
4.2.3.6 Peristaltic Pump Tubes and Mobile Handpiece Support 26
4.2.3.7 Tube-to-Tube Connector 26
4.2.3.8 Irrigation Bag Support Rod and Fixed Handpiece Support 27
4.2.4 Automatic Cleaning 27
4.2.4.1 Materials Required 27
4.2.4.2 Automatic Cleaning Procedure 28
4.2.5 Cleaning Check 29
4.2.6 Drying and Lubrication 29
4.2.7 Sterilization 31
4.2.7.1 Sterilization Method 32

III

IV
PAGE INTENTIONALLY LEFT BLANK

1
INTRODUCTION
1 INTRODUCTION
Carefully read this manual before
proceeding with the cleaning and
sterilization operations, and always keep it
within reach.
IMPORTANT: to prevent harm to persons
or damages to objects, read all the “Safety
precautions”present in the manual with
special care. Depending on their degree
of seriousness, the safety precautions are
classied with the following indications:
WARNING: (always refers to personal
injury)
CAUTION: (refers to possible damage to
property)
The purpose of this manual is to make
the operator knowledgeable of the safety
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 cleaning and sterilization
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
its products with possible modications to
device components.
In case you uncover discrepancies between
what described in this manual and the device
in your possession, contact your Retailer or the
After-Sales Service of Mectron for clarication
and support.
LIMITATION ON THE NUMBER OF
CLEANING AND STERILIZATION CYCLES:
Cleaning and sterilization cycles repeated over
time have minimum eects on the instruments
examined in this Manual. The life expectancy
of the products is usually determined by their
consumption and by damages caused from
their use.
WARNING: The operators who perform
the cleaning and sterilization operations
must be adequately protected and trained.
WARNING: Infections control. First
use: All new and repaired accessories are
supplied in NON STERILE conditions. Before
use, and after each treatment, they must be
cleaned and sterilised in strict compliance
with the instructions given in the Cleaning
and Sterilization Manual. Subsequent uses:
After every treatment, clean and sterilize all
the reusable parts and accessories, following
the instructions provided in the Cleaning and
Sterilization Manual.
WARNING: The cleaning processes must
be commenced immediately after each use.
Do not allow that contaminated instruments
dry up before starting the cleaning and
sterilization process. To eliminate organic
remains such as blood, bone, and other,
use an enzymatic detergent with neutral pH
(pH7), immediately after use.
CAUTION: Do not use metallic brushes
or abrasive sponges during the cleaning
processes, because they damage the surfaces
of the treated parts and the nishes of the
inserts. Only use brushes with soft nylon
bristles.
CAUTION: The detergent solution must
be completely removed from the treated
parts to prevent accumulation of chemical
residues.
CAUTION: During cleaning procedures
only use detergents with pH 6-9.
CAUTION: If you intend to disinfect,
we recommend that you use water-based
disinfectant solutions with a neutral pH (pH
7). Alcohol-based disinfectant solutions and
hydrogen peroxide are contra-indicated,
because they can fade the color and/or
damage the plastic materials. This also holds
true for chemical products such as acetone
and alcohol. Always rinse with sterile water to
preserve the disinfection.
WARNING: Do not use tap water, unless
where explicitly indicated.

2
WARNING: Reusable accessories that
must be forwarded to an Authorized
Mectron Service Center.
All the parts must be cleaned and sterilized
in accordance to the procedures described
in this Manual, before they are sent to
an Authorized Mectron Service Center.
Incorrectly treated and bio-contaminated
parts will not be accepted by the Authorized
Mectron Service Centers.
2 CLEAN/FLUSH FUNCTION
The CLEAN/FLUSH function (according to the device used) enables to run a cleaning cycle on the
irrigation circuit of the handpiece used during the treatment, by following the steps described
in this chapter.
CAUTION: Clean/ush function. The
CLEAN/FLUSH function must be used after
every treatment, before starting the cleaning
and sterilization procedures.
CAUTION: If the tubes are not cleaned,
the crystallization of the salts may seriously
damage the device.
CAUTION: The handpiece and the cord
cannot be separated.
2.1 Preparation
Close the ow of the adjuster.
Disconnect the ow adjuster from the
irrigation bag and from the peristaltic
pump tube or from the tube of the bone
grafting kit, if used.
Dispose of the ow adjuster correctly,
following the norms in force locally on
the disposal of hospital wastes;
1
Prepare an enzymatic detergent solution
with pH 6-9, as per the instructions of the
manufacturer;
2

3
CLEAN/FLUSH FUNCTION
Immerse the end part of the peristaltic
pump tube or the tube of the bone
grafting kit, if used, in a container
containing the enzymatic detergent
solution prepared;
3
Position the handpiece, with or without
insert, above a container to contain
the liquid that will outow during the
cleaning cycle;
4
2.2 PIEZOSURGERY®touch
To enter the cleaning mode, select
PUMP/CLEAN on the keyboard: all the
other selection options present on the
display are disabled, and the PUMP/
CLEAN writing ashes;
NOTE: You can exit the cleaning mode
by pressing on PUMP/CLEAN again or,
alternatively, by waiting for at least 15
seconds. The Clean function is disabled
and the keyboard is enabled again, and
displays the last setting used;
1

4
To make the Clean function start while
the PUMP/CLEAN writing is ashing,
press the foot pedal once and release
it: PUMP/CLEAN stops ashing and the
cleaning cycle starts;
NOTE: The Clean function can be
interrupted at any time by pressing
the PUMP/CLEAN writing again or,
alternatively, by pressing on foot pedal.
The keyboard is enabled again, and
displays the last setting used;
2
As soon as the peristaltic pump starts, the
entire scale of values of the “irrigation”
section lights up and during the liquid
passage, the value of the irrigation shifts
from 6 a 0 . The cycle lasts 20 seconds.
Once it has ended, the keyboard is
enabled again, and displays the last
setting used;
Proceed with the procedure described in
Chapter 2.4 on page 5 .
3
2.3 PIEZOSURGERY®white
To enter the cleaning mode keep the
PUMP/FLUSH button on the touch
keyboard pressed; the LED of the level 6
of the function Irrigation ashes; all other
buttons are disabled. To stop the FLUSH
function release the button;
Proceed with the procedure described in
Chapter 2.4 on page 5.
1
Blu
R=66 G=124 B=254
1
0

5
DISASSEMBLING OF PARTS
2.4 Perform the Cleaning Cycle
To perform a cleaning cycle of every
handpiece, tube, or connector used
during the same treatment, repeat the
operations described in Chapter 2.2 on
page 3 or in Chapter 2.3 on page
4 depending on the device;
1
IMPORTANT: After the cleaning cycle
with the enzymatic detergent solution,
perform a new cleaning cycle with
distilled water to remove detergent
residues.
2
Once you have nished cleaning the irrigation circuit, move on to the cleaning and sterilization
of each single part.
3 DISASSEMBLING OF PARTS
Before proceeding with the cleaning procedures described in Chapter 4 on page 9 , disconnect
all the accessories and components of the device.
WARNING: Switch the device o.
Always turn the device o via the switch,
and disconnect the power supply cable
from the power outlet and from the
device console, before performing the
cleaning and sterilization interventions.
WARNING: Supplementary
grounding cable. If present, disconnect
the supplementary grounding cable
before you perform the cleaning and
sterilization interventions.
1
off

6
Remove the handpiece xed holder and
the irrigation bag support rod from the
device console;
2
Disconnect the foot pedal from the
device:
Grab the connector of the foot pedal,
press the release flap, and pull the
connector back;
CAUTION: Do not attempt to
unscrew or turn the connector during
the disconnection: the connector could
get damaged.
CAUTION: When disconnecting the
foot pedal, always and only hold the
connector of the cord. Never actually
pull on the cord itself.
3
Disconnect the handpiece from the
device;
CAUTION: To avoid damaging the
handpiece, disconnect it by always
holding onto the connector only. Never
pull the cord.
4

7
DISASSEMBLING OF PARTS
CAUTION: Do not attempt to
unscrew or turn the connector when
disconnecting the handpiece.
The connector could get damaged.
CAUTION: The handpiece and cord
cannot be separated.
Completely open the peristaltic pump
and remove the peristaltic pump tube
or the tube of the bone grafting kit (if
present). Close the pump again;
5
Disconnect the peristaltic pump tube
from the connector of the handpiece;
6

8
If the bone grafting kit has been used,
disconnect the tube-to-tube connector
from the peristaltic pump tube and from
the tube of the bone grafting kit;
7
If present, unscrew the insert from the
handpiece by using the torque wrench;
WARNING: During the tightening
and removing operations, the user must
pay particular attention to avoiding
injury from inserts with sharp points and
cutting edges.
8
Unscrew the front cone of the handpiece;
NOTE: USE OF THE HANDPIECE WITH
LIGHT: on the cone with LED light the
metal ring cannot be separated from the
cone in plastic;
9
Remove the protective foil from the
keyboard, if present.
10

9
CLEANING AND STERILIZATION
4 CLEANING AND STERILIZATION
This table is purely indicative.
For the complete cleaning and sterilization
procedures of the individual parts, refer to the
chapters indicated in the table.
CAUTION: Methods not included in the
table below must not be used.
Device surface and Pedal
Step Ref. Procedure
I 4.1 Manual cleaning with detergent
Accessories (Handpiece, Inserts, Torque Wrench, Peristaltic Pump Tubes, Handpiece
Mobile Support, Tube-to-Tube Connector, Irrigation Bag Support Rod and Handpiece
Fixed Support)
Step Ref. Procedure
Handpiece /
Rod / Hand-
piece Fixed
Support
Pump Tubes
/ Handpiece
Mobile Sup-
port
In-
serts
Tube-
to-Tube
Connec-
tor
Torque
Wrench
II 4.2.2
Pre-Cleaning
a)
Manual clean-
ing with enzy-
matic deter-
gent
Immersion into enzymatic detergent
III
4.2.3
Manual clean-
ing
Manual clean-
ing with enzy-
matic deter-
gent
Immersion
into enzy-
matic deter-
gent
Immersion into enzymatic de-
tergent and ultrasonic wash-
ing
4.2.4
Automatic
cleaning Thermal disinfector with detergent
IV 4.2.5
Cleaning
Check Visual inspection with 2,5x lens
V 4.2.6
Drying and lu-
brication Drying
Drying
and Lu-
brication
VI 4.2.7 Sterilisation Packaging, Sterilisation and Storage
a) Optional.

10
4.1 Cleaning of the Console and of the Foot Pedal
4.1.1 Preparation
Make sure that all the following accessories
have been removed/disconnected from the
device console (see Chapter 3 on page 5 ):
• electrical power supply cable;
• foot pedal;
• peristaltic pump tube;
• handpiece;
• handpiece xed support;
• irrigation bag support rod;
• protective foil (if present);
• supplementary grounding connector
(if present).
WARNING: Do not sterilize the device
console and the foot pedal: it could stop
working and cause harm to person and/or
damages to things.
WARNING: Always turn the device o
via the switch and disconnect it from the
electrical network before performing the
cleaning and disinfection interventions.
WARNING: The device is not protected
against penetration of liquids. Do not spray
liquids directly onto the surface of the device.
CAUTION: Do not clean the device
console and the foot pedal under running tap
water.
CAUTION: Do not immerse the device
console and the foot pedal in liquids and/or
solutions of various nature.
4.1.2 Materials Required
• Clean, soft cloths with low ber-release;
• Detergent solution (pH 6-9).
CAUTION: If you wish to disinfect, we
recommend that you use water-based
disinfectant solutions with neutral pH (pH7).
Alcohol-based disinfectant solutions and
hydrogen peroxide are contra-indicated,
because they can fade the color and/or
damage the plastic materials. This also holds
true for chemical products such as acetone
and alcohol.

11
CLEANING AND STERILIZATION
4.1.3 Cleaning Method
Clean the surface of the device with a
clean, soft cloth with low ber-release,
dampened with a detergent solution (pH
6-9);
1
pH 6-9
Dry the device console and the foot pedal
with a clean, non-abrasive cloth with low
ber-release.
2

12
4.2 Cleaning of Accessories
4.2.1 Preparation
1. Perform the CLEAN/FLUSH function
(see Chapter 2 on page 2 );
2. Disconnect the handpiece from the
device console;
3. Disconnect the peristaltic pump tube
from the connector of the handpiece;
4. Remove the tube from the peristaltic
pump. If the bone grafting kit has been
used, disconnect the tube-to-tube
connector from both tubes;
5. If present, disconnect the insert from
the handpiece with the torque wrench;
6. Unscrew the front terminal of the
handpiece;
7. Disconnect the irrigation bag support
rod from the device console.
Refer to Chapter 3 on page 5 for the
disconnection of all accessories.
CAUTION: The handpiece and the cord
cannot be separated.
CAUTION: Disconnect the handpiece
from the device exclusively acting on the
connector.
CAUTION: Always disconnect the insert
from the handpiece before proceeding to its
cleaning and sterilization.
CAUTION: Do not immerse the
handpiece in disinfectant solutions or other
liquids, because it could get damaged.
CAUTION: Do not immerse the
handpiece in an ultrasonic tank.
NOTE: Choose between the following
cleaning methods.
In case the practice is not equipped with a
thermodisinfector, the cleaning process can
begin with the manual cleaning ( Chapter
4.2.3 on page 20 ) and proceed with the
sterilization ( Chapter 4.2.7 on page 31 ).
In case the practice is equipped with a
thermodisinfector the cleaning process
can be performed with automatic cleaning
( Chapter 4.2.4 on page 27 ). The nal step
is always the sterilization ( Chapter 4.2.7 on
page 31 ).
CAUTION: The cleaning and sterilizing
operations described in the following
paragraphs are to be performed upon initial
use and prior to all successive uses.
CAUTION: The following instructions
have been validated by the medical device
manufacturer as ABLE to reprocess a
medical device for being reused. It is up to
the process responsible to assure that the
repeated processes are actually performed by
means of equipment, materials and personnel
structured as repeated processes in order
to obtain the desired result. Generally this
requires the validation and the systematic
monitoring of the process. Similarly, in
case the person in charge of the process
deviates from the supplied instructions,
he shall properly evaluate any action and
their eciency and the possible undesired
consequences.