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Mectron COMBI Touch Manual

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0% found this document useful (0 votes)
110 views90 pages

Mectron COMBI Touch Manual

Uploaded by

Tiberiu Tiberiu
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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EN

Û Use and maintenance manual

MULTIPIEZO
PRO
COMBI touch
08 J

01

F I K

05
09

E A

02

B
C

M N 03 04 06 07
V

P
refill W

Q U

T R T Y X
Û TABLE OF CONTENTS
01 Û INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
01.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
01.2 Description of the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
01.3 Responsibility waiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
EN 01.4 Safety precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
01.5 Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

02 Û IDENTIFICATION DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
02.1 Device identification plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
02.2 Scaler Handpiece identification plate . . . . . . . . . . . . . . . . . . . . . . . . 98
02.3 Insert identification data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
02.4 Polisher Tip identification data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

03 Û DELIVERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
03.1 List of components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

04 Û INSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
04.1 First installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
04.2 Safety precautions during installation . . . . . . . . . . . . . . . . . . . . . . 101
04.3 Connection of accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

05 Û USE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
05.1 Switching the device on and off . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
05.2 Description of the keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
05.2.1 ULTRASOUND - Scaler side . . . . . . . . . . . . . . . . . . . . . . . . . 107
05.2.2 POLISHING - Polishing side . . . . . . . . . . . . . . . . . . . . . . . . 109
05.3 Safety precautions before and during use. . . . . . . . . . . . . . . . . . . 112
05.4 Instructions for use - Scaler side . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
05.5 Important information on the inserts . . . . . . . . . . . . . . . . . . . . . . . 116
05.6 Instructions for use - Polishing side . . . . . . . . . . . . . . . . . . . . . . . . 117
05.7 Instructions for use - “refill” function . . . . . . . . . . . . . . . . . . . . . . . 119

06 Û “flush” FUNCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

90
COMBI touch

07 Û DISASSEMBLY OF PARTS FOR CLEANING


AND STERILIZATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
08 Û CLEANING AND STERILIZATION . . . . . . . . . . . . . . . . . . . . . . . . . 129
08.1 Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130 EN
08.2 Polishing parts that cannot be sterilized . . . . . . . . . . . . . . . . . . . . 130
08.3 Cleaning the irrigation solution container and cap . . . . . . . . . . . 131
08.4 Cleaning accessories that can be sterilized . . . . . . . . . . . . . . . . . . 133
08.4.1 Manual cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
08.4.2 Combined manual/automatic cleaning . . . . . . . . . . . . . . . 143
08.4.2.1 Manual pre-wash . . . . . . . . . . . . . . . . . . . . . . . . . . 143
08.4.2.2 Mechanical cleaning . . . . . . . . . . . . . . . . . . . . . . . 150
08.4.3 Automatic cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
08.5 Cleaning verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
08.6 Drying and lubrication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
08.7 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

09 Û MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
09.1 Replacement of the peristaltic pump . . . . . . . . . . . . . . . . . . . . . . . 158
09.2 Cleaning and/or replacing the water filter . . . . . . . . . . . . . . . . . . . 160
09.3 Eliminating condensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
09.4 Cleaning powder containers and cap . . . . . . . . . . . . . . . . . . . . . . . 162

10 Û DISPOSAL MODES AND PRECAUTIONS . . . . . . . . . . . . . . . . . 162

11 Û TECHNICAL DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163


11.1 Electromagnetic compatibility EN 60601-1-2 . . . . . . . . . . . . . . . . 165

12 Û TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
12.1 Diagnostic system and symbols on the keyboard . . . . . . . . . . . . 169
12.2 Quick solutions to problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
12.3 Replacement of fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
12.4 Sending the device to an Authorized Mectron Service Center 174

13 Û WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

91
COMBI touch

01 Û INTRODUCTION
Carefully read this manual before The purpose of this manual is for the
proceeding with the installation, use, operator knowledge regarding the safety
maintenance, or other operations on the precautions, the installation procedures,
device. Always keep this manual within and the instructions for correct use
reach. and maintenance of the device and its
accessories.
EN IMPORTANT: To prevent harm to persons
or damages to objects, read all the “Safety Use of this manual for purposes other than
precautions” present in the manual with those strictly tied to the installation, use
special care. Depending on their degree and maintenance of the device is forbidden.
of seriousness, the safety precautions are The information and illustrations in this
FODVVLÀHGZLWKWKHIROORZLQJLQGLFDWLRQV manual are updated as of the date of issue
reported on the last page.
WARNING Mectron is committed to continually
(always refers to personal injury) updating its products with possible
CAUTION PRGLÀFDWLRQVWRGHYLFHFRPSRQHQWV,QWKH
(refers to possible damage to event you uncover discrepancies between
property) what is described in this manual and the
device in your possession, contact your
Retailer or the After-Sales Service of Mectron
IRUFODULÀFDWLRQVDQGVXSSRUW

01.1 Û INTENDED USE


The COMBI touch combines a multifunctional Polisher for prevention and dental
piezoelectric scaler and a water jet, air and hygiene.
sodium bicarbonate or glycine powder Indications:
polisher in a unique device, intended for a - Removal of bacterial plaque - using Mectron
complete supragingivale and subgingival powder only (Prophylaxis powder);
prophylaxis treatment. - Removal of subgingival bacterial plaque,
Ultrasonic piezo scaler XVLQJJO\FLQHEDVHGSRZGHUZLWKVSHFLÀF
Using the appropriate inserts, the following intended use;
dental applications can be performed: 5HPRYDORIELRÀOPLQWKHLPSODQWSDWLHQWIRU
- scaling: all procedures for the removal the purpose of preventing of periimplantitis,
of bacterial plaque deposits and supra- through the use of glycine-based powder
gingival, sub-gingival, and interdental ZLWKVSHFLDOVSHFLÀFDWLRQRIXVH
calculus, and for the removal of stains; - Removal of stains on the tooth surface due
- periodontology: periodontal treatment to tobacco, coffee, tea and chlorhexidine -
for scaling and root-planing/debridement, use Mectron powder only (Prophylaxis
including cleaning and irrigation of powder);
periodontal pockets; - Prophylaxis on patients under going
- cleaning of implant surfaces; orthodontic treatment, using glycine-based
- endodontics: all treatments for root canals SRZGHUZLWKVSHFLÀFLQWHQGHGXVH
SUHSDUDWLRQLUULJDWLRQÀOOLQJFRQGHQVDWLRQ - Preparation of cavities for better adhesion
of gutta-percha, endodontic revision and EHWZHHQHQDPHODQGÀOOLQJPDWHULDOXVH
retrograde preparation; Mectron powder only (Prophylaxis powder);
- restoration and prosthesis: cavity - Polishing the surface of the enamel.
preparation and removal of carious tissues,
removal of restorations and of excess
restoration material, condensation of the
DPDOJDPÀQLVKLQJRIWKHFHUYLFDOPDUJLQ
- extraction techniques.
92
01 Û INTRODUCTION

DANGER: In the presence of


composite resin surfaces, the jet must be
directed towards the part to be treated,
on average 2-3 seconds per tooth.

WARNING: The device must be of the device does not cause side effects if
used in a dental practice or ambulatory applied correctly. An improper use might
facility. The device cannot be operated cause tissues heating.
in environments where anesthetic or WARNING: Use the device for
EN
ÁDPPDEOHPL[WXUHVDUHSUHVHQW intended use only.
WARNING: 4ualiÀed and Failure to observe this precaution may
specialized personnel. The device must cause serious injuriy to the patient, the
be used exclusively by specialized and operator, and damage/breakdown to the
appropriately trained personnel. The use device.

01.2 Û DESCRIPTION OF THE DEVICE


The COMBI touch combines a multifunctional of treatment to be performed: Prophylaxis
piezoelectric scaler and a water jet, air and Powder dedicated to supragingival
a sodium bicarbonate and glycine powder prophylaxis and glycine-based powder
polisher in a unique device, intended for dedicated to subgingival treatment.
a complete supragingival and subgingival The operating principle of the polisher is
prophylaxis treatment. based on the mechanical action obtained
Concerning the various treatments possible from a jet of various types of crystals
using ultrasound, the COMBI touch DFFHOHUDWHGE\DÁRZRIFRPSUHVVHGDLU
allows work to be performed using the The kinetic energy applied to the particles,
water supply of the dental practice and with dissipates almost completely due to impact
independent irrigation through a dedicated against the surface of the enamel, producing
liquid container, which can house different a gentle yet effective cleaning action. The
types of medicinal solutions. action is completed by a jet of water which,
The device is equipped with an automatic using the vacuum created around the nozzle,
tuning circuit, which compensates for the KDVDEHOOVKDSHDURXQGWKHPDLQÁRZWKXV
wear of the inserts, thus always allowing producing a dual effect: to prevent much of
operation in conditions of maximum the rebound and the leakage of the cloud of
HIÀFLHQF\ powder and perform continuous washing of
The polishing side makes the use of two types the treated area, dissolving the powder.
of powder possible, depending on the type

93
COMBI touch
01.3 Û RESPONSIBILITY WAIVER
The manufacturer, Mectron, disclaims any 5 Assembly operations, extensions,
liability, expressed or implied, and shall have adjustments, updates, and repairs on
no responsibility for any direct, indirect or the device performed by personnel not
other damages and personal injury arising authorized by Mectron;
out of or in connection with any errors in the 6 Improper use, mistreatments, and/or
use of the device and its accessories. incorrect interventions;
The manufacturer, Mectron, shall be under no 7 Any and all attempts to tamper with
EN liability, expressed or implied, with respect to or modify the device, under any
circumstance;
any damages (personal injury and/or damage
to property) which might arise or be caused, 8 Use of non-original Mectron inserts that
whether by the customer or by any of the FDXVHDÀQLWHGDPDJHWRWKHWKUHDGLQJRI
users of the product, and its accessories, as the handpiece, thus compromising correct
result of: operation and causing risk of harm to the
1 Use of or procedures not indicated other patient;
WKDQWKRVHDVVSHFLÀHGLQWKHLQWHQGHGXVH 9 Use of inserts other than authentic
of the product; Mectron inserts, used in accordance to the
2 Environmental conditions for the designed and tested settings of Mectron
preservation and storage of the device not authentic inserts. The correct use of the
compliant with the precautions indicated in settings is guaranteed only with original
Chapter 11 - TECHNICAL DATA; Mectron inserts;
3 Device not being used in compliance with 10 Lack of backup components and
all instructions and precautions described accessories (handpiece, inserts, wrenches,
in this manual; scaler handpiece, polisher tips, subgingival
4 Electrical system located in the premises in perio tips) are to be used in the event of
which the device is used not compliant deviations from device proper use due to
with the electrical code compliance defects or other occurrences.
standard and to relative precautions;

94
01 Û INTRODUCTION
01.4 Û SAFETY PRECAUTIONS
WARNING: Contraindications. Do Before every treatment, always check
not use the COMBI touch on patients who that the device works perfectly and that
carry heart stimulators (Pacemakers) or WKHDFFHVVRULHVDUHLQHIÀFLHQWZRUNLQJ
other implantable electronic devices. This order. In the event you uncover operating
precaution also applies to the operator. abnormalities, do not perform the
WARNING: Contraindications. Do treatment. Contact an Authorized Mectron
not perform scaling treatments without
Service Center if the abnormalities the
device. EN
irrigation to avoid insert over-heating,
which may cause damage to the tooth. CAUTION: The electrical system
Treatments with no can be carried out located on the premises in which the
only with “Irrigation Free” inserts which do device is installed and used must be
not have the water passage. compliant with the electrical code
compliance standards in force and to the
CAUTION: Contraindications.
relative electrical safety precautions.
Ultrasonic scaler. Do not perform
treatments on restorations made of metal CAUTION: To avoid any risk of electric
or ceramics. As a result, the ultrasonic shock, this device must be grounded.
vibrations could lead to de-cementing of WARNING: All of the accessories
restorations. provided with new or repaired devices
WARNING: Contraindications. are not sterile. All new and repaired
Interference from other equipment. An accessories are supplied in non-sterile
conditions. Before use, and after each
electrical scalpel or other electro-surgical
treatment, they must be cleaned and
units near the COMBI touch device may
sterilized in strict compliance with the
interfere with its correct operation.
instructions given in the Chapter 08 -
WARNING: Contraindications. CLEANING AND STERILIZATION.
Interference with other equipment. WARNING: Infection control.
Though compliant to the IEC 60601-1-2 To ensure maximum safety of patient and
standard, the COMBI touch may operator, before using all the reusable
nonetheless interfere with other devices SDUWVDQGDFFHVVRULHVWKH\VKRXOGÀUVW
nearby. The COMBI touch must not be be cleaned and sterilized, following the
used near to or stacked on other devices. instructions in Chapter 08 - CLEANING
However, if this is necessary, you must AND STERILIZATION.
check and monitor correct operation of
CAUTION: Contraindications. Prior
WKHGHYLFHLQWKDWFRQÀJXUDWLRQ
to re-usage, allow reusable, autoclavable
CAUTION: In the case that the end items (handpiece, inserts, torque wrench,
user, when operating in his or her own and any other accessory that can be
dental facility or clinic, must subject the sterilized ) to gradually return to room
electro-medical equipment and systems to temperature after steam sterilization. The
periodical inspections in order to adhere cooling process must not be accelerated.
to imposed requirements, test procedures WARNING: Insert breakage and
that must be applied to electro-medical wear. High frequency oscillations and
equipment and systems to evaluate safety wear and tear may, in rare circumstances,
must be performed in conformance lead to insert breakage.
with standard EN 62353 ‘Electro-medical Deformed or otherwise damaged inserts
devices - Periodical inspections and tests are susceptible to breakage during their
to be performed after repair interventions use. These inserts must never be used.
on electro-medical devices’. If an insert breaks, check that none of its
WARNING: Checking device status fragments remain in the treated area and,
before the treatment. Always affect at the same time, apply effective suction
there is no water underneath the device. to remove them.

95
COMBI touch

The patient must be instructed to breathe WARNING: Contraindications -


through their nose during the treatment, Jet polisher.
or a dental dam must be used to prevent Patients that are on a low sodium diet
the patient from ingesting fragments of or who suffer from serious respiratory
broken inserts. problems, such as chronic bronchitis,
When the nitride coating wears off of the asthma, emphysema, etc. must not
LQVHUWWKHFXWWLQJHIÀFLHQF\GHFUHDVHV undergo the prophylaxis treatment, until
re-sharpening the insert damages it and is they have consulted with their doctor.
EN therefore forbidden. Always check that the
insert is not worn out.
WARNING: Contraindications - Jet
polisher.
During the treatment, frequently check Patients wearing contact lenses should
that the insert is intact, especially in its remove them prior to receiving treatment
apical part. with the jet polisher.
During the treatment, avoid prolonged
contact with retractors or with metallic WARNING: Contraindications -
instrumentation in use. Do not exert Prophylaxis powder jet polisher.
excessive pressure on the inserts during Do not aim the jet of air/Prophylaxis
use. powder/water onto soft tissues or inside
the gingival sulcus. Failure to comply with
WARNING: Only use authentic
this direction can cause gingival tissue
Mectron inserts, accessories, and
emphysema (emphysema of the mucosa
replacement parts.
and/or subcutaneous). Use only Glycine-
CAUTION: 1RPRGLÀFDWLRQRIWKLV based powder for this kind of treatments.
equipment is allowed.
WARNING: Temperature of the
CAUTION: Contraindications. Prior
water spray - Jet polisher.
to re-usage, allow reusable, autoclavable
This device is equipped with a double
items (handpiece, inserts, torque wrench,
safety mechanism that controls the
and any other accessory that can be
temperature of the water spray. Before
sterilized ) to gradually return to room
treatment, it is however recommended to
temperature after steam sterilization. The
instruct the patient to inform the operator
cooling process must not be accelerated.
if they perceive an excessive increase in
the temperature of the water.

96
01 Û INTRODUCTION
01.5 Û SYMBOLS
Serial number
Lot number

Product code

Warning: read the instructions for use

Operating instructions
EN
Use-by date

Do not use if the packaging is not intact

Sterilized using ethylene oxide


70 °C

-10 °C
Temperature limitation - transport and storage conditions
90 %

Humidity limitation - transport and storage conditions


10 %
1060 hPa

500 hPa
Atmospheric pressure limitation - transport and storage conditions

It indicates compliance with the CE 93/42 CEE EN 60601-1 and EN 60601-1-2.


1RWLÀHGERG\CERMET.
Nemko Mark
UL CSA conformity

Manufacturer

Date of Manufacture

QTY.1 Quantity of parts in the pack = 1


Do not re-use

Applied part of type “B” as per norm EN 60601-1

Can be sterilized in autoclave up to a maximum temperature of 135° C

Non-sterile

The device and its accessories must not be disposed


of or treated as solid urban wastes

Biohazard
I Activation switch “on”
0 Activation switch “off”
Alternating current
Connection of the foot pedal

Rx Only For US market only


CAUTION US Federal Law restricts this device to sale by or on the order of a dentist
97
COMBI touch

02 Û IDENTIFICATION DATA
An exact description of the model and serial number of the device will enable our After-Sales
6HUYLFHWRSURYLGHIDVWDQGHIÀFLHQWVXSSRUW
Always provide this information whenever you contact an Authorized Mectron Service Center.

EN
02.1 Û DEVICE IDENTIFICATION PLATE
(YHU\GHYLFHKDVDQLGHQWLÀFDWLRQSODWHWKDW manufacturer
bears the technical characteristics and the
Mectron S.p.A.
Via Loreto 15/a
VHULDOQXPEHU7KHLGHQWLÀFDWLRQSODWHLV yyyy 16042 Carasco -GE- Italy

located on the inferior panel of the device. COMBI touch


100-240 V~ 90 VA - 50/60 Hz.
$GGLWLRQDOVSHFLÀFDWLRQVDUHUHSRUWHGLQWKLV Intermittent operation
manual (See Chapter 11 - TECHNICAL DATA). Electrical Safety
ES 60601-1

Rx only
0476

205000000 made in Italy

02.2 Û HANDPICE IDENTIFICATION DATA


The handpiece is laser-marked with the 1 2
Mectron logo (ref. 1) and with its serial
number (ref. 2).

98
02 Û IDENTIFICATION DATA

02.3 Û INSERT IDENTIFICATION DATA


The following data are laser-marked on each
insert: the name of the insert (ref. 3), the
Mectron logo (ref. 4) and the lot number to
which the insert belongs (ref. 5).
EN

3 4 5

02.4 Û POLISHER TIP IDENTIFICATION DATA


The following data are laser-marked on each
insert: the name of the polisher tip (ref. 6), the
Mectron logo (ref. 7) and the lot number to
which the insert belongs (ref. 8).
6 7 8

99
COMBI touch

03 Û DELIVERY
03.1 ÛLIST OF COMPONENTS
See inside cover
The COMBI touch consists of:
A device body
EN B peristaltic pump
C foot pedal with cord and connector
D electrical power supply cable
E mectron torque wrench
F manual of use and maintenance
G 2 polisher containers complete with cap
H 3 polisher tips: 90° (PO 90) / 120° (PO 120) / PERIO
I polisher handpiece
J inserts/insert kit
K scaler handpiece complete with LED light front cone
L irrigation solution containers complete with caps
M water supply tubing with quick coupling
N air supply tubing with quick coupling
O accessories:
O1 metal front cone without light
O2 UHSODFHPHQWÀOWHUIRUZDWHUFLUFXLW
O3 Ø 0,8 mm needle
O4 Ø 0,4 mm needle
O5 screw-on lids for the irrigation solution containers
O6 packet of Glycine Powder (for European market only)
O7 packet of Prophylaxis Powder
O8 subgingival perio tip
O9 K9 wrench

The COMBI touch has accessories available When receiving the device, check for the
that can be ordered separately. The quantity possible presence of damages incurred
and type of accessories supplied with during the transport and, should that be the
the device you have purchased can vary FDVHÀOHDFRPSODLQWZLWKWKHWUDQVSRUWHU
according to promotional campaigns and to Preserve the package in the event that you
the country where the unit is sold. need to send the device to an Authorized
The package of the device is sensitive Mectron Service Center and for storing the
to strong collisions, because it contains device during prolonged periods of non-use.
electronic components.
Therefore, special precautions must be taken WARNING: Before commencing
for transport and storage. operation of the device, make sure that
Do not stack multiple boxes, in order not to you have additional accessories, such
damage the packages underneath. as, scaler handpiece, inserts, wrenches,
All the materials shipped by Mectron have polisher tips, subgingival perio tips,
been inspected upon their delivery. available to use in case of deviations from
The device is delivered duly protected and device proper use due to defects or other
packed. occurrences..

100
04 Û INSTALLATION

04 Û INSTALLATION
04.1 Û FIRST INSTALLATION
The device must be installed in a comfortable In the event that your device requires an
and suitable place for its use. activation key, the procedures to follow may
The COMBI touch can be purchased ready for vary from country to country.
instantl use or may have to be enabled by Always refer to your retailer to obtain
typing an activation key. information on the above. EN

04.2 Û SAFETY PRECAUTIONS DURING INSTALLATION


WARNING: Contraindications. WARNING: Install and use the device
Interference with other equipment. in a place protected against collisions
Though compliant with the standard or against accidental sprays of water or
IEC 60601-1-2, the COMBI touch may liquids.
nonetheless interfere with other devices WARNING: Do not install the device
nearby. above or near heat sources. Adequate
The COMBI touch must not be used near air circulation around the device when
to or stacked on other devices. However, installing it is necessary.
if this were to prove necessary, you must
check and monitor correct operation of CAUTION: Do not expose the device
WKHGHYLFHLQWKDWFRQÀJXUDWLRQ to direct sunlight or to of UV light sources.
WARNING: Contraindications. CAUTION: The device can be
Interference from other equipment. An transported, but it must be handled
electrical scalpel or other electro-surgical with care. Position the foot pedal on the
units near the COMBI touch device may ground, so that it can only be activated
interfere with its correct operation. intentionally by the operator.
CAUTION: The electrical system CAUTION: Before connecting the
located on the premises in which handpiece to its cord, make sure that
the device is installed and used must the electrical contacts are entirely dry,
be compliant to the electrical code on both sides. If need be, dry them with
compliance standards in force and to the compressed air.
relative electrical safety precautions. CAUTION: Position the device in a way
CAUTION: To avoid any risk of electric that the power plug is easily accessible at
shock this device must be grounded. all times; this is considered a insulation
means.
WARNING: Risk of explosion.
The device cannot operate in CAUTION: Each irrigation solution
environments where there are saturated container has a maximujm capacity of
DWPRVSKHUHVRIÁDPPDEOHJDVHV 500 ml.
(aesthetic mixtures, oxygen, etc.).

101
COMBI touch
04.3 Û CONNECTION OF THE ACCESSORIES
Connect the foot pedal to the back of
1
the device in the socket marked with the
symbol with the plug of the pedal
cable, until you hear a “click” sound.

CAUTION: Pay attention to the


positioning of the pedal, so that the
EN pedal is only activated intentionally by
the operator.

Dischargeany condensation from the


2
compressed air supply - connect the air
supply tubing to the practice’s air supply
using the relative reduction and cut-off
valve (not provided by Mectron).
Connect the quick coupling to the male
attachment on the rear of the device;

Connect the supply tubing to the practice’s


3
water circuit using the relative reduction
and cut-off valve (not by Mectron).
Connect the quick coupling to the male
attachment on the rear of the device;

Insert the power supply cable in its


4
connection located at the back of the
device. Connect it to the power outlet;

CAUTION: Position the device in


such a way that the power plug is easily
accessible at all times; this is considered
a insulation means.

102
04 Û INSTALLATION
Unscrew the cap from the irrigation
5
VROXWLRQFRQWDLQHUDQGÀOOLQWKHLUULJDWLRQ
solution container with the needed
solution;

CAUTION: each irrigation solution


container can contain liquids up to a
maximum of 500 ml.

EN
Check that the hose connected to the
6
irrigation solution container’s cap is
correctly installed, then screw the cap back
on the irrigation solution container;

CAUTION: check that the female


coupling of the cap is clean and free
from impediments.

CAUTION: check that the male


coupling on the unit is clean and that its
o-rings are not worn.

Keep the irrigation solution container in a


7
vertical position and push it towards the
XQLW·VERG\XQWLOLWLVÀUPO\FRQQHFWHG

CAUTION: Do not capsize the


irrigation solution container as its cap
is not watertight. The leaking of the
physiological solution or of aggressive
liquids can damage the surfaces.

Correctly connect the handpiece to its


8
cord making sure to match the dot on the
handpiece connector with the groove on
the cord connector.
Make sure that the electrical contacts of
both handpiece and cord are entirely dry;
if need be, dry them by blowing
compressed air;

103
COMBI touch
Position the handpiece on its support.
9

EN
CAUTION: Before extracting the 10
powder containers or unscrewing the
caps, make sure that the device is off and
disconnected from the main electricity
RUWKH´UHÀOOµIXQFWLRQKDVEHHQVHOHFWHG
and the corresponding LED is on with a
À[HGOLJKW VHHSDUDJUDSK),//-
ING THE POWDER CONTAINERS).
Loosen the cap of the white PROPHY
powder container.
CAUTION: The PROPHY powder
FRQWDLQHULVLGHQWLÀHGGXHWRE\PHDQV
of its white color.

Pour the Prophylaxis Powder into the


11
container, making sure that the level
reaches the diffuser inside.
WARNING: Introduce only
Prophylaxis Powder into the PROPHY
container.
CAUTION: Correct level of powder
in the tank.
Minimum level: The level of powder in
the container must not be lower than
one centimeter to prevent cleaning
performance from dropping.
Maximum level: The level of the
powder in the container must remain
below the diffuser (at least 5 mm).

Close the cap on the container without


12
tightening it excessively.

104
04 Û INSTALLATION
Loosen the cap of the blue PERIO powder
13
container.
CAUTION: The PERIO powder
FRQWDLQHULVLGHQWLÀHGE\PHDQVRIWRLWV
blue color.

EN
Pour the Glycine-based powder into the
14
container, making sure that the level
reaches the diffuser inside.
WARNING: Introduce only glycine-
based powder into the PERIO container.
CAUTION: Correct level of powder
in the tank.
Minimum level: The level of powder in
the container must not be lower than
one centimeter to prevent cleaning
performance from dropping.
Maximum level: The level of the
powder in the container must remain
below the diffuser (at least 5 mm).

Close the cap on the container without


15
tightening it excessively.

105
COMBI touch

05 Û USE
05.1 Û SWITCHING THE DEVICE ON AND OFF
Turning the device on
With the device in view from its front side,
position the switch on the left of the device
EN body on position “I”, being careful not to press
the foot pedal.
On the device, all of the signals switch on and
switch off successively. The keyboard
remains off for a few seconds until
an acoustic signal, which indicates the end of
the diagnostics cycle. At this point, the device
positions itself on the default setting and is
ready for use.
Default setting: CAUTION: Position the device in
a way that the power plug is easily
ULTRASOUND side accessible at all times; this is considered a
“endo” mode insulation means.
power ”1”
light “Off”
-DUV\PEROLUULJDWLRQDYHUDJHÁRZUDWH
POLISHING side
“prophy” function
NOTE: The setting operations for the scaler
part and the polisher part can be performed
simultaneously only with the handpieces at
rest. If one of the two handpieces is lifted,
only the settings of the active function can be
changed.
Turning the device off
With the device in view from its front side,
position the switch on the left of the device
body on position “O”, being careful not to press
the foot pedal.
The device turns off.

106
05 Û USE
05.2 Û DESCRIPTION OF THE KEYBOARD
Touch keyboard
7KHXVHUFDQFRQÀJXUHWKHGHYLFHE\VLPSO\
touching on the touch surface.
Depending on the selected setting, the
electronic feedback system automatically
adjusts the correct operating frequency.
refill
PLEASE NOTE: A brief acoustic signal is EN
emitted to indicate the selection of a key.
A prolonged acoustic signal is emitted to
indicate that the key cannot be selected for
said setting.

05.2.1 ULTRASOUND - Scaler side


FUNCTIONS
(ref. P inside cover)
Depending upon the type of treatment, it
is possible to choose one of the 3 options
available from the mode list, as follows:
‡ ´endoµ: dedicated to endodontic
treatments such as cleaning of root canals
and retro grade approach.
‡ ´perioscalerµ: dedicated to supra- and
sub-gingival prophylaxis procedures, to root
planing and to implant cleaning.
‡ ´restorativeµ: dedicated to restoration,
prosthesis and extraction techniques.
PLEASE NOTE: by selecting “restorative” and
power on 6 the PULSE mode is activated. It is
used to optimize the insert’s performance in
the extraction and prosthesis techniques.

´soft modeµ
(ref. Q inside cover)
The treatment can be made more delicate
for sensitive patients, by activating the “soft
mode” function.
“Soft mode” can only be activated
in the “perio/scaler” functions with powers
from 1 to 5 and “restorative” with powers
from 1 to 4.
In “endo” mode the function is not available.

107
COMBI touch
POWER
(ref. R inside cover)
For all functions previously described, the
power for use can be adjusted by selecting
the numbers on the power scale. Five power
levels are available, from 1 to 5: the work
power can be adjusted in an incremental
manner (1minimum power, 5maximum
EN power).

LIGHT
(ref. S inside cover)
Depending on the front tip of the scaler
handpiece and the type of treatment to
be performed, the light function can be
activated:
‡by activating the “on/off“ key; the LED light
on the scaler handpiece front tip switches
on when the pedal is pressed and switches
off automatically after 3 seconds from pedal
release;
‡by deactivating the “on/off“ key, the LED
light of the scaler handpiece front tip is
always off.

The position of the LED light on the front


terminal of the handpiece can be adjusted in
the following way:
‡Hold the body of the handpiece and lightly
unscrew the metal ring nut located at
the base of the front terminal, rotating it
counter-clockwise;
‡Rotate the front terminal so that the LED
light goes into the desired and necessary
position;
‡To fasten it into position, screw the metal
ring nut, rotating it clockwise.

108
05 Û USE
IRRIGATION
refill

(rif. T inside cover)


For the scaler side, the device allows the use
of two types of irrigation: the normal water
circuit or the jar circuit.
7KHÁRZUDWHRIWKHWZRFLUFXLWVFDQEH
regulated as follows:
- for the normal water circuit, it can be
refill
regulated continuously through the left
hand knob;
EN
- for the jar circuit it can be continuously
regulated on 7 levels via the touch surface
using the “–“ and “+” keys.
Irrigation can be excluded in “endo”, “perio/
scaler” modes with power levels
from 1 to 5 and “restorative” with power
levels from 1 to 4.

CAUTION: The exclusion of irrigation


with non “irrigation free” inserts can cause
overheating with consequent breakage of
the handpiece.

PLEASE NOTE: On regulation of the irrigation


ÁRZUDWH ´µDQG´µ DSURORQJHGDFRXVWLF
signal is emitted when high full scale is
reached.
PLEASE NOTE:7KHLUULJDWLRQÁRZUDWHFDQEH
changed by pressing the “-” and “+” keys also
during the treatment (maintaining the pedal
pressed).

109
COMBI touch
´Flushµ FUNCTION
(ref. U inside cover)
The device has a “flush” key, which allows the
refill
irrigation circuit to be filled and rinsed.
Filling the irrigation circuit: Before starting
the treatment, the “flush” function can be
used, which allows:
the liquid to reach the insert in order to start
EN the treatment with the necessary irrigation.
Cleaning the hydraulic circuit:
The “flush” function allows the irrigation
circuit rinse cycle to be performed. This
function must be used at the end of the
treatment and before cleaning and sterilizing
all parts.
NOTE: If both handpieces are at rest, the
“flush” function cannot be activated.

05.2.2 POLISHING - Polishing side


FUNCTIONS
(ref. V inside cover)
Depending on the type of application, one
of the 2 types of powder can be selected as
follows:
‡ ´prophyµ: dedicated to the clinical
indications of the sodium carbonate-based
powder;
‡ ´perioµ: dedicated to the clinical indications
of the glycine-based powder;
refill

´reÀllµ FUNCTION
(ref. W inside cover)
The “refill” function must be used to
depressurize the powder containers in order
to then be able to open and remove them
from the device.

refill

110
05 Û USE
IRRIGATION
(ref. X inside cover)
The device uses just normal water for
polishing.
The water circuit flow rate can be regulated
continuously through the right hand knob.
refill

EN

´Flushµ FUNCTION
(ref. U inside cover)
The “flush” function can be used when you
want to pass from the Prophylaxis powder to
Glycine, and vice versa, in order to be sure
that the powder circuit is clean from that
previously used.
refill

NOTE: If both handpieces are at rest, the


“flush” function cannot be activated.

SYMBOLS
(ref. Y inside cover)
The COMBI touch is equipped with a
diagnostic circuit that allows for detection
of operating abnormalities and to view their
type on the touch surface via their relative
refill symbol.
To help the user identify the malfunctioning
part, three symbols are visible which are
described in paragraph 12.1.

111
COMBI touch
05.3 Û SAFETY PRECAUTIONS BEFORE AND DURING USE
WARNING: Only use authentic CAUTION: Contraindication. Do
Mectron inserts, accessories, and not perform treatments on prosthetics
replacement parts. made of metal or ceramics. The ultrasonic
vibrations could lead to the de-cementing
WARNING: Before starting to operate
of the prosthetic dental work.
with the device, make sure that you have
additional material (scaler handpiece, WARNING: Contraindications. Do
EN inserts, wrenches, polisher tips, subgingival not use the COMBI touch on patients who
perio tips) available to use in case of carry heart stimulators (Pace-makers) or
deviations from device proper use due to other implantable electronic devices. This
defects or other occurrences. precaution also applies to the operator.
WARNING: Checking device WARNING: Contraindications. Do
status before the treatment. Always not perform scaling treatments without
check that there is no water underneath water spray in order to avoid the insert
the device. Before every treatment, over-heating which may cause damage to
always check that the device works the tooth. Treatments with no water spray
perfectly and that the accessories are in can be carried out only with “Irrigation
working order. In the event you uncover free” inserts which do not have the water
operating abnormalities, do not perform passage.
the treatment. Contact an Authorized
Mectron Service Center concerning device CAUTION: Only use inserts with water
abnormalities. passage when performing treatments that
require irrigation.
WARNING: Infection control.
First use: All new and repaired accessories WARNING: Treatments that require
are supplied in NON STERILE conditions. irrigation. Always check the operation of
Before use, and after each treatment, the irrigation before and during use. Make
they must be cleaned and sterilized in VXUHWKHÁXLGRXWÁRZVIURPWKHLQVHUW
strict compliance with the instructions Do not use the device if the irrigation
provided in Chapter 08 - CLEANING AND does not work or if the pump is defective.
STERILIZATION. WARNING: To ensure that the
Subsequent uses: After every treatment, handpiece cools down, always activate it
clean and sterilize all the reusable parts
with the irrigation circuit correctly installed
and accessories, following the instructions
DQGÀOOHG7RÀOOWKHLUULJDWLRQFLUFXLW
provided in Chapter 08 - CLEANING AND
always use the FLUSH function.
STERILIZATION.
CAUTION: To correctly use the
WARNING: The patient must not
device, you must press the foot pedal
come into contact with the device body or
the foot pedal. and start it with the insert not making
contact with the part to be treated, so
CAUTION: ´Áushµ function. The that the electronic circuit can recognize
´ÁXVKµIXQFWLRQPXVWEHXVHGDIWHUHYHU\ the best point of resonance of the insert
treatment, before starting the cleaning without interferences, allowing its optimal
and sterilization procedures. performance.
Ultrasonic scaler WARNING: Before every treatment,
WARNING: Use of non-authentic make sure that the insert appropriate
Mectron inserts: WKLVXVHZLOOFDXVHÀQLWH for the treatment is inserted on the
damage to the handpiece threading, thus handpiece.
compromising correct operation and Exclusively use the Mectron torque wrench
risking harm to the patient. to fasten the insert to the handpiece.

112
05 Û USE

WARNING: Do not change the insert wrench, and any other accessory that can
while the handpiece is operating, to be sterilized ) to gradually return to room
prevent causing injury to the operator. temperature after steam sterilization. The
CAUTION: FLUSH function. After cooling process must not be accelerated.
the device is used with aggressive and CAUTION: The electrical contacts of
non-aggressive solutions, it is necessary to both handpiece and cord connectors
perform a cleaning cycle on the tubes and
the handpiece with the FLUSH function
must be dry. Before connecting the
handpiece to its cord make sure that the
EN
(see Chapter 06 - FLUSH FUNCTION). electrical contacts of both connectors
If the tubes are not cleaned, the are entirely dry, especially after the
crystallization of the salts may seriously sterilization cycle in the autoclave.
damage the device. If necessary, dry the contacts by blowing
WARNING: Breakage and worn compressed air onto them.
inserts. High frequency oscillations and CAUTION: 'XHWRLWVFRQÀJXUDWLRQ
wear-out may, in rare circumstances, lead the handpiece can rotate. When not in
to the breakage of the insert. use, the handpiece must always be placed
Do not bend, change the shape of, or on its support.
re-sharpen an insert in any way. Jet polisher:
Bending an insert or applying leverage on
it can lead to its breakage. WARNING: Contraindications.
Deformed or otherwise damaged inserts Patients that are on a low sodium diet
are susceptible to breakage during their or who suffer from serious respiratory
use. If this occurs, these inserts must never problems, such as chronic bronchitis,
be used again. asthma emphysema, etc. must not
Excessive pressure on the inserts during undergo the prophylaxis treatment, until
their use can lead to their breakage. they have consulted with their doctor.
If an insert breaks, check that none of its WARNING: Contraindications.
fragments remain in the treated area and, Patients wearing contact lenses should
at the same time, apply effective suction remove them prior to receiving treatment
to remove them. with the bicarbonate jet polisher.
The patient must be instructed to breathe WARNING: Contraindications -
through their nose during the treatment, Prophylaxis powder jet polisher.
or a dental dam must be used to prevent Do not aim the jet of air/Prophylaxis
the patient from ingesting fragments of powder/water onto the soft tissues or
broken inserts. inside the gingival sulcus. Failure to
When the nitride coating wears off, the comply with this instruction can cause a
FXWWLQJHIÀFLHQF\GHFUHDVHVUHVKDUSHQLQJ gingival tissue emphysema (emphysema
the insert damages it and is therefore of the mucous and/or subcutaneous). Use
forbidden. Check that the insert is not only Glycine-based powder for this kind of
worn out. treatments.
During the treatment, frequently
check that the insert is intact, especially WARNING: Temperature of the
its top. water spray. The device is equipped with
During the treatment, avoid prolonged a double safety device that controls the
contact with retractors or with metallic temperature of the water spray. Before the
instrumentation in use. treatment, it is however recommended to
instruct the patient to inform the operator
CAUTION: Contraindications. Prior if they perceives an excessive increase in
to re-use, a reusable, autoclavable items the temperature of the water.
(the handpiece, the inserts, the torque

113
COMBI touch

WARNING: Checking infections and WARNING: Do not use the device


cleaning the water and air circuits. without water.
For maximum safety of the patient and Make sure that the device is connected
operator, after every treatment, follow to the water circuit and the water cap is
the instructions provided in chapter 08 - open.
CLEANING AND STERILIZATION. WARNING: Do not attempt to
unscrew the cap of the powder container
EHIRUHKDYLQJSHUIRUPHGWKH´UHÀOOµF\FOH
EN

05.4 Û INSTRUCTIONS FOR USE - Scaler side


After having connected all the accessories as illustrated in Paragraph 04.3 proceed as follows:

Raise the scaler handpiece, with or


1
without insert, load the irrigation circuit by
selecting “flush” on the keyboard.
7KH´IOXVKµIXQFWLRQ/('ÁDVKHV
The device allows the use of two types of
irrigation: the normal water circuit or the
jar circuit. refill

ATTENTION: Make sure that the


polisher handpiece is in a resting
position, otherwise the device remains
inactive.

Press the pedal for a moment to start the


2
cycle. The LEDs of the “flush” function
DQGW\SHRILUULJDWLRQVHOHFWHGÁDVK7KH
performance of the cycle is indicated with
brief sequence of acoustic signals.
The cycle lasts 23 seconds, but can be
interrupted by pressing the pedal as soon
as liquid is observed escaping from the
handpiece.
Upon completion of the “flush” cycle,
the device goes back to being active and
repositions itself at the last setting used;

114
05 Û USE
Screw the chosen insert onto the COMBI
3
touch handpiece, until it reaches its limit
and can go no further;

EN
Tighten the insert by using the Mectron
4
torque wrench.
To correctly use the Mectron torque
wrench, operate as follows:

Place the insert inside the wrench as


5
CORRECT shown;

NOT CORRECT

Firmly hold the central body of the


6
handpiece;

CAUTION:The handpiece must not


click!
be grabbed by its terminal part and/or
cord, but only by its central body.
The handpiece must not be rotated, but
PXVWEHJUDVSHGÀUPO\DQG\RXPXVW
only rotate the wrench.

Rotate the wrench clockwise until the


friction snaps (the external body of the
wrench rotates compared to the handpiece,
emitting mechanical “CLICK” sounds).
The insert is now perfectly tightened;

115
COMBI touch
On the touch surface, select the type of
7
function and irrigation necessary and the
light, if desired;
Lift the handpiece and press the foot pedal
in order to start the treatment;

EN
At the end of the treatment, position the
8
scaler handpiece on its support.

05.5 Û IMPORTANT INFORMATION ON THE INSERTS


WARNING:
- When the titanium nitride coating is voiding the warranty, damages
visibly worn, the insert must be replaced. the threading of the COMBI touch
Use of a worn insert reduces handpiece, with the risk of no longer
LWVHIÀFLHQF\ being able to screw the original
- Diamond-coated inserts: the diamond inserts correctly during subsequent
inserts must be replaced when the use. Moreover, the device settings
titanium nitride coating is visibly worn are tested and guaranteed to operate
and, at any rate, after a maximum of 10 correctly only when authentic Mectron
treatments. inserts are used.
- Do not activate the handpiece while - Do not change the shape of the insert
the insert is in contact with the treated LQDQ\ZD\E\HLWKHUEHQGLQJRUÀOLQJLW
area, so that the electronic circuit can This could cause the insert to break.
recognize the best point of resonance - Do not use an insert that has suffered
of the insert and allow its optimal any type of deformation.
performance. - Do not attempt to sharpen an insert.
- Check the condition of wear of the insert - Always check that the threaded parts
and that it is intact before and during of the insert and of the handpiece
every use. In the event that a drop in are entirely clean – see Chapter 08 -
performance becomes apparent, CLEANING AND STERILIZATION.
replace it. - If excessive pressure is applied on the
- Use authentic Mectron inserts only. Use insert, it can cause the insert to break
of non-authentic inserts, in addition to and possibly harm the patient.

116
05 Û USE
05.6 Û USER INSTRUCTIONS - POLISHER SIDE
After having connected all of the accessories as illustrated in Paragraph 04.3, proceed as follows:

Lift the polisher handpiece. The POLISHING


1
function is activated.

CAUTION: Make sure that the scaler


handpiece is in its resting position;
otherwise the device remains inactive. EN
refill

Select the type of polisher tip on the basis


2
of the operation to be performed;

CAUTION: The subgingival perio


tip can only be used with the PERIO
polisher tip.

Take the polisher handpiece, run the ferrule


3
and maintain it in this position, insert the
polisher tip fully to the home position and
then release the handpiece ferrule;
Select the desired “prophy” or “perio”
function.
´Prophyµ function: use Mectron
Prophylaxis Powder;
´Perioµ function: XVHVSHFLÀFJO\FLQH
based powder for subgingival use.

WARNING: Before proceeding with


successive operations, make sure that
the polisher tip is inserted correctly, fully
to the home position on the polisher
handpiece (the handpiece ferrule and
the polisher tip must be in contact) and
that the ferrule has returned to its initial
position.

117
COMBI touch

CAUTION: If the PERIO polisher tip 3b


has been selected, the subgingival perio
tip must be inserted onto the front.
CAUTION: Handle the front
subgingival tip with care.
CAUTION: Use only Glycine-based
powder with the PERIO polisher tip.

EN
Insert the front subgingival tip onto the
4
PERIO polisher tip, pushing it fully home.

WARNING: Make sure that the


subgingival perio tip is correctly
inserted fully home on the polisher tip;
the two pieces must be in contact.
CAUTION: Use authentic Mectron
accessories only.

Press the pedal to start treatment. The


5
ÁRZRIZDWHUFDQEHUHJXODWHGE\WKHULJKW
hand knob until the desired amount is refill

reached.

At the end of the treatment, put the


6
polisher handpiece back in its seat.

refill

118
05 Û USE
05.7 Û OPERATING INSTRUCTIONS - „refill“ FUNCTION
7KH´UHÀOOµIXQFWLRQDOORZVUHPRYDORISUHVVXUH N.B.: The powder containers are only under
from the powder containers, enabling pressure when, after being selected, the pedal
opening or removal, and preventing powder is pressed.
from escaping. This function must be used
whenever a container is to be reloaded or ATTENTION:'XULQJWKH´UHÀOOµF\FOH
cleaned. air and powder escape from the cleaner
handpiece.

EN
OPERATION:
7RUXQWKH´UHÀOOµF\FOHSURFHHGDVIROORZV

3UHVVWKH´UHÀOOµEXWWRQ
1

refill

Wait for completion of the cycle, during


2
ZKLFKWKH/('RIWKH´UHÀOOµEXWWRQZLOO
ÁDVKWRJHWKHUZLWKWKDWRIWKHSUHVVXULVHG
powder container emitting a beep.

N.B.: If both of the powder containers


refill
DUHSUHVVXULVHGWKH´UHÀOOµF\FOHZLOO
depressurise both.
N.B.:'XUDWLRQRIWKH´UHÀOOµF\FOHYDULHV
according to the presence of only one
or both of the depressurised powder
containers. With only one powder
container pressurised the cycle lasts 7
seconds while with both powder containers
pressurised it lasts 12 seconds.

At the end of the cycle the LED of the


3
´UHÀOOµEXWWRQZLOOUHPDLQRQDQGVWHDG\
and it will then be possible to open or
remove the containers.

refill

119
COMBI touch
At this point simply close or re-insert the
4
containers to continue using the device.
N.B.: If the powder containers are not
opened or removed, simply press the
´UHÀOOµEXWWRQWRUHWXUQWRWKHODVWSURJUDP
used.

EN refill

120
06 Û ´IOXVKࢽ FUNCTION

06 Û “flush“ FUNCTION
7KH´ÁXVKµIXQFWLRQDOORZVWKHLUULJDWLRQFLUFXLWWREHILOOHGDQGULQVHG

CAUTION: FLUSH function. The CAUTION: Scaler side: If the tubing


FLUSH function must be used after every is not cleaned, crystallization of salts may
treatment, before starting the cleaning and seriously damage the device.
sterilization procedures.
EN

ULTRASOUND - Scaler part


Fill the liquid irrigation solution container
1
on the basis of the cycle to be performed:
,IWKHMDULUULJDWLRQFLUFXLWPXVWEHÀOOHGXVH
the pre-selected liquid;
If the jar irrigation circuit rinse cycle is
being performed, use water, preferably
demineralised.
Connect the irrigation solution container to
the device;

Lift the scaler handpiece.


2

CAUTION: Make sure that the


polisher handpiece is in the rest position
otherwise the device remains inactive.

Position the scaler handpiece, with or


3
without insert, above a container to
FRQWDLQWKHOLTXLGWKDWZLOORXWÁRZGXULQJ
the cleaning cycle;

121
COMBI touch
7RHQWHUWKHÁXVKLQJPRGHVHOHFW)/86+
4
menu on the touch surface: all the other
selection options present on the display are
disabled.
The type of irrigation previously selected
remains active and the corresponding
refill

/('ÁDVKHV IDGLQJ WKHRWKHUVHOHFWLRQV


present are deactivated.
PLEASE NOTE: <RXFDQH[LWWKHÁXVKLQJ
EN mode at any time by pressing FLUSH menu,
the touch surface is enabled again, and
displays the last setting used;

It is possible to change the type of


5
LUULJDWLRQZLWKZKLFKWRSHUIRUPWKH´ÁXVKµ
cycle, by pressing the key with image of the
cap and the irrigation solution container;

refill

To make the FLUSH function start while the


6
)/86+LQGLFDWRULVÁDVKLQJSUess the foot
pedal once and release.
The LEDs of the function and type of
LUULJDWLRQVHOHFWHGÁDVK7KHSHUIRUPDQFH
of the cycle is indicated with brief sequence
acoustic signals; refill

PLEASE NOTE: the FLUSH function can


be interrupted at any time by pressing the
FLUSH indicator again or, alternatively, by
pressing on foot pedal. The touch surface is
enabled again, and displays the last setting
used;

The cycle lasts 23 seconds. Once it has


7
ended, the touch surface is enabled again,
and displays the last setting used.

refill

122
06 Û ´IOXVKࢽ FUNCTION
If the ´ÁXVKµ cycle is to be performed on
8
the water circuit, repeat the steps from
point 4 selecting irrigation with water.
Upon conclusion of the function selection
time or on completion of the ´ÁXVKµ cycle,
the device returns to being active and
refill

repositions itself at the last setting used;


NOTE: If the water circuit ´ÁXVKµ cycle is
performed, remember to open the tap.
EN

After the cleaning cycle of the irrigation


9
circuit, proceed with disassembing
the different parts (see Chapter 07 -
DISASSEMBLY OF PARTS FOR CLEANING
AND STERILIZATION) and to their cleaning
and sterilization (see Chapter 08 -
CLEANING AND STERILIZATION).

CAUTION: If the handpiece is


placed back onto its support, with the
´ÁXVKµIXQFWLRQVHOHFWHG
ÁDVKLQJ/(' EXWQRWUXQQLQJWKH
function is exited;
CAUTION: During execution of the
´ÁXVKµF\FOHLHZKHQWKHIXQFWLRQKDV
been selected and activated by pressing
the foot pedal, if the scaler handpiece is
put back on the support, the cycle is not
interrupted.

123
COMBI touch
POLISHING - Polishing side

Lift the polisher handpiece.


1

CAUTION: Make sure that the scaler


handpiece is in its resting position;
otherwise the device remains inactive.

EN

Position the polisher handpiece, with or


2
without the polisher tip, on a receptacle
that can contain the liquid and powder that
ZLOOHVFDSHGXULQJWKH´ÁXVKµF\FOH

7RHQWHUWKH´ÁXVKµIXQFWLRQE\VHOHFWLQJ
3
´ÁXVKµRQWKHWRXFKVXUIDFHWKHSUHYLRXVO\
selected powder container remains
DFWLYHDQGWKHFRUUHVSRQGLQJ/('ÁDVKHV
(fading), the other selections present are
deactivated. refill

PLEASE NOTE:7KH´ÁXVKµPRGHFDQEH
deactivated at any time by pressing the
´ÁXVKµEXWWRQDJDLQ7KHWRXFKVXUIDFH
goes back to being active, repositioning
itself at the last setting used;

It is possible to change the powder


4
FRQWDLQHURQZKLFKWKH´ÁXVKµF\FOHLVWREH
performed, if it is in place, by selecting the
corresponding key on the touch surface;
refill

124
06 Û ´IOXVKࢽ FUNCTION
Press the foot pedal once and release it to
5
start the cycle. The LEDs of the function
DQGSRZGHUFRQWDLQHUVHOHFWHGZLOOÁDVK
The performance of the cycle is indicated
with a brief sequence of acoustic signals;
PLEASE NOTE: The execution of the
refill
´ÁXVKµF\FOHFDQQRWEHLQWHUUXSWHGEHIRUH
SHUIRUPLQJWKH´ÁXVKµF\FOHFKHFNWKDWWKH
right-hand tap is open;
EN

The cycle lasts 23 seconds. Once it has


6
ended, the touch surface is enabled again,
and displays the last setting used.

refill

After the cleaning cycle of the irrigation


7
circuit, disassemble the different parts
(see Chapter 07 - DISASSEMBLY OF PARTS
FOR CLEANING AND STERILIZATION) and
proceed to their cleaning and sterilization
(see Chapter 08 - CLEANING AND
STERILIZATION).

CAUTION: If the handpiece is


positioned on its support, with the
´ÁXVKµIXQFWLRQVHOHFWHG ÁDVKLQJ/(' 
but not running, the function is exited.
CAUTION: During execution of the
´ÁXVKµF\FOHLHZKHQWKHIXQFWLRQKDV
been selected and activated by pressing
the foot pedal, if the handpiece is put
back on the support, the cycle is not
interrupted.

125
COMBI touch

07 Û DISASSEMBLY OF PARTS FOR CLEANING


AND STERILIZATION
Before proceeding to the cleaning procedures described in Chapter 08 - CLEANING AND
STERILIZATION, disconnect all the accessories and components of the COMBI touch.

WARNING: Switch the device off. 1


Always turn the device off by its switch,
EN and disconnect the power supply cable
from the power outlet and from the
device body, before performing the
cleaning and sterilization procedures.

Disconnect the foot pedal from the device:


2
Grab the connector of the foot pedal, press
WKHUHOHDVHÁDSDQGSXOOWKHFRQQHFWRU
back;
CAUTION: Do not attempt to
unscrew or twist the connector during
the disconnection: the connector could
become damaged.
CAUTION: When disconnecting the
foot pedal, always and only hold the
connector of the cord. Never actually
pull on the cord itself.

If an insert is connected to the handpiece,


3
unscrew the insert from the handpiece by
using the torque wrench;

Disconnect the handpiece from its cord;


4

126
07 Û DISASSEMBLY

CAUTION: Do not attempt to


unscrew or turn the connector when
disconnecting the scaler handpiece.
The connector could become damaged.

EN
Unscrew the front cone of the handpiece;
5
PLEASE NOTE: on the cone with LED light
the metal ring cannot be separated from
the cone in plastic;

Disconnect the irrigation solution container


6
from the device body by pulling it
outwards;

Take the polisher handpiece, slide the


7
ferrule and maintain it in this position,
extract the polisher tip and then release
the handpiece ferrule;

CAUTION: The polisher handpiece


and its lead cannot be separated.

Where the PERIO cleaner terminal has


7b
been used, remove the perio subgingival
terminal using the K9 wrench supplied and
then proceed to dismantling (Chapter 10);
PLEASE NOTE: Introduce the K9 wrench
exactly into the position indicated
LQWKHÀJXUH

127
COMBI touch

CAUTION: Before extracting the 8


powder containers or unscrewing the
caps, make sure that the device is off
and disconnected from the mains
HOHFWULFLW\RUVWDUWWKH´UHÀOOµIXQFWLRQ
(see paragraph 05.2.2 - FILLING THE
POWDER CONTAINERS).
Extract the powder container from the
EN device, remove the cap
and empty it.
Proceed with polishing. (See CLEANING
POWDER CONTAINERS AND CAP 09.4)
Repeat the operation on the second
powder container of the device if both
have been used.

When the cleaning operation has been


9
completed, re-position the containers in
the device.

ATTENTION: Insert the powder


containers in such a way that the
groove of the bottom of the device
is aligned with the convexity of the
powder container.

128
08 Û CLEANING AND STERILIZATION

08 CLEANING AND STERILIZATION


This table is purely indicative. WARNING: Sterile disposable.
For the complete cleaning and sterilization The sterile disposable subgingival perio
procedures of the individual parts, refer to tips must be used in just one surgical
the paragraphs indicated in the table. treatment and dedicated to just one
patient. The disposable subgingival perio
CAUTION: Methods not included in tips must not be re-used. Separate and
the table below must not be used. dispose of each disposable subgingival EN
perio tip in compliance with the current
regulations regarding hospital waste.

Device body, Pedal, Polisher handpiece, scaler handpiece end part


Phase Paragraph Procedure

I 08.1 Preparation

II 08.2 Manual cleaning with enzymatic detergent

Irrigation solution container and cap


Phase Paragraph Procedure

III 08.3 Manual cleaning with enzymatic detergent and running water

Accessories (Scaler handpiece scaler front tip, Inserts, Polisher tips, K9 wrench,
Dynamometric wrench)
Dynamo-
Scaler Scaler Polisher K9
Phase Paragraph Procedure Inserts metric
handpiece front tip tips. wrench
wrench
Manual cleaning Immersion
Manual with enzymatic detergent into enzymatic detergent
08.4.1
cleaning Ultrasonic washing

Combined Manual cleaning Immersion


IV with enzymatic detergent into enzymatic detergent
cleaning
08.4.2
manual/
automatic Thermal disinfector with detergent
Automatic
08.4.3 Thermal disinfector with detergent
cleaning
Check
V 08.5 Visual inspection -> 2.5X lens
cleaning
Drying and Drying Drying +
VI 08.6 Lubrication
lubrication

VII 08.7 Sterilization Packaging, Sterilization and Storage

Particular information: Sterilization parameters, in steam autoclave,


used in Great Britain: - temperature: 134° C , time: 3 minutes.
129
COMBI touch
08.1 Û PREPARATION
PREPARATION WARNING: Always turn the device off
5XQWKH´ÁXVKµIXQFWLRQ by its the switch and disconnect it from
(see chapter 02); the electrical network before performing
- Check that all of the following accessories the cleaning and disinfection procedures.
have been removed/disconnected from the CAUTION: The polisher handpiece
device body (see Chapter 07): and the cable cannot be separated.
EN ‡(OHFWULFSRZHUVXSSO\FDEOH
‡3HGDO
CAUTION: Always disconnect the
insert from the handpiece before cleaning
‡6FDOHUKDQGSLHFH and sterilizing it.
‡,QVHUWV
CAUTION: Do not immerge the
‡3ROLVKHUWLS
handpiece in disinfectant solutions or
‡:DWHUDQGDLUSLSH
other liquids, because it could become
CAUTION: The cleaning and sterilizing damaged.
operations described in the following CAUTION: Do not immerge the
paragraphs are to be performed upon handpiece in an ultrasonic tank.
initial use and prior to all successive uses.
ATTENTION: Where the powder is
excessively wet, remove/disconnect the
cleaner terminal from the handpiece,
remove powder residue from the channel
of the cleaner handpiece using the Ø 0,8
mm cleaning needle supplied and then
SHUIRUPWKH´ÁXVKµIXQFWLRQZLWKRXWWKH
cleaner terminal.

08.2 Û POLISHING PARTS THAT CANNOT BE STERILIZED


The following procedure must be performed ‡3HGDODQGUHODWLYHFRQQHFWLRQFDEOHWRWKH
on all device parts that cannot be sterilized, device;
except for the irrigation solution container ‡3ROLVKHUKDQGSLHFHDQGUHODWLYHOHDG
and its cap. The parts in question are: ‡(QGSDUWRIWKHVFDOHUKDQGSLHFHDQG
‡'HYLFHERG\ relative lead.

MATERIALS NECESSARY
&OHDQVRIWFORWKVZLWKORZÀEHUUHOHDVH
- Detergent solution (pH 6-9).

CLEANING METHOD
Clean the surface of the parts using a clean,
1
GU\FORWKZLWKORZÀEUHUHOHDVHGDPSHQHG
with a detergent solution (pH 6-9);

pH 6
-9

130
08 Û CLEANING AND STERILIZATION
Dry the parts using a dry, non-abrasive
2
FORWKZLWKORZÀEHUUHOHDVH

EN

WARNING: Do not sterilize the scaler CAUTION: Do not clean the foot
handpiece: it could stop working and pedal under running tap water.
cause harm to persons and/or damage to CAUTION: Do not immerge the foot
items. pedal in liquids and/or solutions of various
WARNING: Always turn the device off nature.
by its switch and disconnect it from the CAUTION: Do not immerge the
electrical network before performing the handpiece in disinfectant solutions or
cleaning and disinfection procedures. other liquids, because it could become
WARNING: The device and the scaler damaged.
handpiece are not protected against CAUTION: Do not immerge the
penetration of liquids. Do not spray liquids handpiece in an ultrasonic tank.
directly onto the touch surface of the
device and the scaler handpiece (these
cannot be sterilized).

08.3 Û CLEANING THE IRRIGATION SOLUTION CONTAINER


AND CAP
PREPARATION
- Disconnect the irrigation solution container CAUTION: Do not sterilize the
from the device body (see Chapter 07); irrigation solution container and its cap
- Unscrew the cap from the irrigation solution in an autoclave, they could become
container. damaged.

MATERIALS NECESSARY
- Water CAUTION: If you intend to disinfect
the irrigation solution container and its
- Detergent solution (pH 6-9).
cap, we recommend that you use water-
&OHDQDQGVRIWFORWKZLWKORZÀEHUUHOHDVH based disinfectant solutions with a neutral
- Sterile water 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.
Always rinse with sterile water to preserve
the disinfection.

131
COMBI touch
CLEANING METHOD - Irrigation solution container and cap
Carefully rinse under running water the
1
internal and the external surfaces of the
irrigation solution container and of the cap;

EN
Clean the external surfaces of the irrigation
2
solution container and of the cap with a
FOHDQVRIWFORWKZLWKORZÀEHUUHOHDVH
dampened with a detergent solution
(pH 6-9);

Thoroughly rinse the inside and outside


3
of the irrigation solution container under
running water to eliminate all residues of
the detergent solution;

Remove any detergent remaining with a


4
VRIWFORWKZLWKORZÀEHUUHOHDVHGDPSHQHG
with sterile water in order to maintain the
disinfection;

2QFH\RX·YHÀQLVKHGWKHFOHDQLQJ
5
procedure, check the irrigation solution
container and the cap under an adequate
source of light, paying attention to the
areas that could conceal dirt residues
(cavities, grooves) and, if need be, repeat
the cleaning cycle.

132
08 Û CLEANING AND STERILIZATION
08.4 CLEANING ACCESSORIES THAT CAN BE STERILIZED
PREPARATION CAUTION: The instructions provided
The following parts of the device can be below have been validated by the
sterilized: manufacturer of the medical device as
‡6FDOHUKDQGSLHFH ABLE to prepare a medical device for re-
‡6FDOHUIURQWWLS use. The person in charge of the process is
‡,QVHUWV responsible for ensuring that the processes
‡,QVHUWVWRUTXHZUHQFK
‡3ROLVKHUWLSV
repeated are effectively performed using
the equipment, materials and staff in the
EN
‡.ZUHQFK reprocessing structure in order to obtain
the desired result. This generally requires
Before verifying the cleaning (paragraph
the validation and systematic monitoring
08.5), drying and lubrication (paragraph
of the process. Similarly, all deviations
08.6) and then sterilization (paragraph 08.7),
from the instructions provided by the
depending on requirements, one of the three
processe manager must be adequately
possible cleaning methods must be selected,
DVVHVVHGWRMXGJHWKHLUHIÀFLHQF\DQG
which are explained in-depth in the following
potential undesired consequences.
sub-paragraphs.

08.4.1 MANUAL CLEANING


MATERIALS NECESSARY CAUTION: If you intend to disinfect,
we recommend that you use water-based
- Enzymatic detergent at pH 6-9;
disinfectant solutions with a neutral
- Ø 0,4 mm polishing needle; pH (pH7). Alcohol-based disinfectant
- Water; solutions and hydrogen peroxide are
- Container for immersion in the enzymatic contraindicated, because they can fade
liquid; the color and/or damage the plastic
materials. This also holds true for chemical
- Ultrasonic tank; products such as acetone and alcohol.
&OHDQVRIWFORWKVZLWKORZÀEUHUHOHDVH Always rinse with sterile water to preserve
- Brush with soft nylon bristles; the disinfection.
- Syringe; CAUTION: Do not use hydrogen
peroxide. If you intend to disinfect
- Demineralised water.
the accessories, do not use hydrogen
peroxide, but only disinfectants with
neutral pH (pH7); always rinse with sterile
water to preserve the disinfection.

Prepare an enzymatic detergent solution


1
with pH 6-9, as per the instructions of the
manufacturer;

CAUTION: Once used, dispose of


the enzymatic detergent correctly, do
not recycle it.

133
COMBI touch
SCALER HANDPIECE
Clean the surface of the scaler handpiece
2
and of its connector with a clean, soft cloth
ZLWKORZÀEHUUHOHDVHGDPSHQHGZLWKD
detergent solution (pH 6-9).

EN

Delicately clean the surface of the scaler


3
handpiece using the enzymatic detergent
solution with the aid of a brush with soft
nylon bristles, placing special care to the
following areas:
- threading of the handpiece
- titanium stem
- front terminal in its external and internal
parts

Accurately rinse with tap water to eliminate


4
any detergent residues and perform the
last rinse with distilled water;

Process validated by independent bodies with enzymatic


detergent.

134
08 Û CLEANING AND STERILIZATION
INSERTS
Place the insert horizontally in a clean
5
container and add enzymatic detergent
solution until the insert is covered
completely;

EN
Let the insert soak for 10 minutes at 40°C
6
±2°C. This procedure reduces the amount
of blood, protein and mucous present on
the insert;

During immersion in the enzymatic


7
solution, delicately brush the surface of
the insert using the brush with soft nylon
bristles to eliminate all traces of visible dirt.
7KRURXJKO\FOHDQWKHGLIÀFXOWDUHDVVXFKDV
sharp edges;

Delicately brush the surface of the insert


8
under running water using the brush with
soft nylon bristles;

Using a syringe, inject the enzymatic


9
detergent solution 3 times inside the cavity
x3 of the insert to effectively remove the
residues from the internal surface;

135
COMBI touch
Rinse the internal canal of the insert
10
with distilled water injected under pressure
(3,8 bar) for at least 10 seconds to
eliminate all residues;

3,8 bar
10 sec

EN
Place the insert in the ultrasound tank
11
submerged by the enzymatic detergent
solution at 40°C ±2°C, for at least 10
minutes;

Remove the insert from the ultrasonic tank


12
and rinse with distilled water;

Delicately brush the surface of the insert


13
again using the brush with soft nylon
bristles;

Rinse the internal canal of the insert


14
with distilled water injected under pressure
(3.8 bar) for at least 10 seconds to x3
eliminate all residues;

Process validated by independent bodies with enzymatic


detergent.

136
08 Û CLEANING AND STERILIZATION
INSERTS TORQUE WRENCH
Soak the wrench in the enzymatic
15
detergent solution for 10 minutes at 40°C
±2°C;

EN

During immersion in the enzymatic


16
solution, delicately brush the surface of
the wrench using the brush with soft nylon
bristles to eliminate all traces of visible dirt
both in the internal and external part;

Delicately brush the surface of the wrench


17
with a brush with soft nylon bristles under
running water;

Rinse the wrench with demineralised water


18
until all contaminants have been visually
removed;

137
COMBI touch
Place the insert in the ultrasound tank
19
submerged by the enzymatic detergent
solution at 40°C ±2°C, for at least 10 10 min 40°C
minutes;

EN
Rinse with tap water to eliminate all
20
residues;

Delicately brush the surface of the wrench


21
with a brush with soft nylon bristles using
distilled water;

Process validated by independent bodies with enzymatic


detergent.

POLISHER TIPS
Free the channel of the polisher tip from
22
residues of powder using the Ø 0,4 mm
cleaning needle supplied.
Blow compressed air into the central hole
in the tip, from both ends;

CAUTION: Clean the nozzle channel


exclusively using the Ø 0,4 mm cleaning
needle supplied with the device.
CAUTION: If the subgingival perio
tip is present on the polisher tip,
remove it and dispose of it.

138
08 Û CLEANING AND STERILIZATION
Place the polisher tip horizontally in a clean
23
container and add enzymatic detergent
solution until the polisher tip is covered
completely;

EN
Let the polisher tip soak for 10 minutes at
24
40°C ±2°C. This procedure reduces the
amount of blood, protein and mucous
present on the polisher tip;

During immersion in the enzymatic


25
solution, delicately brush the surface of the
polisher tip using the brush with soft nylon
bristles to eliminate all traces of visible dirt.
7KRURXJKO\FOHDQWKHGLIÀFXOWDUHDVVXFKDV
edges and, in particular, the gaps;

Delicately brush the surface of the polisher


26
tip under running water using the brush
with soft nylon bristles;

Using a syringe, inject the enzymatic


27
detergent solution three times inside the
x3 cavity of the polisher tip to effectively
remove the residues from the internal
surface;

139
COMBI touch
Rinse the cavity of the polisher tip using
28
demineralised water injected under
pressure (3.8 bar) for at least 10 seconds, to
eliminate all residues of detergent;

3,8 bar

EN 10 sec

Place the polisher tip in an ultrasonic tank


29
in an enzymatic detergent solution at 40°C
±2°C, for at least 10 minutes;

Remove the polisher tip from the ultrasonic


30
tank and rinse with demineralised water;

Delicately brush the surface of the polisher


31
tip again using the brush with soft nylon
bristles;

Rinse the internal channel of the polisher


32
tip using demineralised water injected
under pressure (3.8 bar) for at least 10
seconds, to eliminate all residues;

3,8 bar
10 sec

140
08 Û CLEANING AND STERILIZATION
K9 WRENCH
Place the K9 wrench in a clean container
33
and add enzymatic detergent solution until
the K9 wrench is covered completely;

EN

Let the wrench soak for 10 minutes at 40°C


34
±2°C. This procedure reduces the
amount of blood, protein and mucous
present on the K9 wrench;

During immersion in the enzymatic


35
solution, delicately brush the surface of the
K9 wrench using the brush with soft nylon
bristles to eliminate all traces of visible dirt.
7KRURXJKO\FOHDQWKHGLIÀFXOWDUHDVVXFKDV
edges and, in particular, the gaps;

Delicately brush the surface of the K9


36
wrench under running water using the
brush with soft nylon bristles;

141
COMBI touch
Place the K9 wrench in an ultrasonic tank
37
in an enzymatic detergent solution at 40°C
±2°C, for at least 10 minutes;

EN
Remove the K9 wrench from the ultrasonic
38
tank and rinse with demineralised water;

Delicately brush the surface of the K9


39
wrench again using the brush with soft
nylon bristles;

142
08 Û CLEANING AND STERILIZATION
08.4.2 COMBINED MANUAL/AUTOMATIC CLEANING
MATERIALS NECESSARY
- Enzymatic detergent CAUTION: If you intend to disinfect
(Mectron ENZYMEC, 0.8% v/v); the accessories, it is recommended to use
- Ø 0,4 mm polishing needle; water-based disinfectants with neutral
pH (pH7). Alcohol-based disinfectant
- Water; solutions and hydrogen peroxide are
- Container for immersion in the enzymatic
liquid;
contraindicated, because they can fade
the color and/or damage the plastic
EN
- Brush with soft nylon bristles; materials. This is also valid for chemical
products such as acetone and alcohol.
- Disposable syringe 20 ml;
Always rinse with sterile water to maintain
- Demineralised water; disinfection.
- Alkaline detergent: neodisher® FA CAUTION: Do not use hydrogen
(0.2 % v/v); peroxide. If you intend to disinfect
- Neutralising liquid: neodisher® FA the accessories, do not use hydrogen
(0.1 % v/v); peroxide, but only disinfectants with
- Metal basket; neutral pH (pH7); always rinse with sterile
water to preserve the disinfection.
- Thermal disinfector.

08.4.2.1 MANUAL PRE-WASH


Prepare an enzymatic detergent* solution
1
with pH 6-9, as per the instructions of the
manufacturer;

CAUTION: Once used, dispose of


the enzymatic detergent correctly, do
not recycle it.

SCALER HANDPIECE
Clean the surface of the scaler handpiece
2
and of its connector with a clean, soft cloth
ZLWKORZÀEHUUHOHDVHGDPSHQHGZLWKD
detergent solution (pH 6-9);

143
COMBI touch
Delicately clean the surface of the
3
handpiece using the enzymatic detergent
solution with the aid of a brush with soft
nylon bristles, placing special care to the
following areas:
- threading of the handpiece
- titanium stem
- front terminal in its external and internal
EN parts

Completely rinse with tap water to


4
eliminate any detergent residues and
perform the last rinse with distilled water;

Process validated by independent bodies with enzymatic


detergent Enzymec (Mectron).

INSERTS
Place the insert horizontally in a clean
5
container and add enzymatic detergent
solution until the insert is covered
completely;

144
08 Û CLEANING AND STERILIZATION
Let the insert soak for 10 minutes at 40°C
6
±2°C. This procedure reduces the amount
of blood, protein and mucous present on
the insert;

EN
Using a 20 ml disposable syringe, inject 20
7
ml of enzymatic detergent solution 3 times
x3 inside the cavity of the insert;

Delicately brush the surface of the insert


8
under running water (drinking water,
temperature 20°C+/- 2°C), in particular the
SDUWVWKDWDUHGLIÀFXOWWRDFFHVV FDYLWLHV
structured surfaces, etc.) using a brush with
soft nylon bristles;
The insert must be brushed until no
residues can be seen (at least 30 seconds);

Using a 20 ml disposable syringe, inject


9
20 ml of cold demineralised water 3 times
x3 inside the cavity of the insert;

Process validated by independent bodies with enzymatic


detergent Enzymec (Mectron).

145
COMBI touch
INSERTS TORQUE WRENCH
Soak the wrench in the enzymatic
10
detergent solution for 10 minutes at 40°C
±2°C;

EN

8VLQJDPOGLVSRVDEOHV\ULQJHÁXVKWKH
11
surface of the wrench three times with 20
ml of enzymatic detergent solution; x3

Delicately brush the surface of the wrench


12
under running water (drinking water,
temperature 20°C+/- 2°C), in particular the
SDUWVWKDWDUHGLIÀFXOWWRDFFHVV FDYLWLHV
structured surfaces, etc.) using a brush with
soft nylon bristles;
The wrench must be brushed until no
residues can be seen (at least 30 seconds);

8VLQJDPOGLVSRVDEOHV\ULQJHÁXVKWKH
13
surface of the wrench 3 times with 20 ml of
enzymatic detergent solution; x3

Process validated by independent bodies with enzymatic


detergent Enzymec (Mectron).

146
08 Û CLEANING AND STERILIZATION
POLISHER TIPS
Free the channel of the polisher tip from
14
residues of powder using the relevant Ø 0,4
mm cleaning needle supplied.
Blow compressed air into the central hole
in the tip, from both ends;

CAUTION: Clean the nozzle channel


exclusively using the Ø 0,4 mm cleaning
EN
needle supplied with the device.
CAUTION: If the subgingival perio
tip is present on the polisher tip,
remove it and dispose of it.

Place the polisher tip horizontally in a clean


15
container and add enzymatic detergent
solution until the polisher tip is covered
completely;

Let the polisher tip soak for 10 minutes


16
at 40°C ±2°C. This procedure reduces the
amount of blood, protein and mucous
present on the polisher tip;

Using a 20 ml disposable syringe, inject 20


17
ml of enzymatic detergent solution 3 times
x3 inside the cavity of the polisher tip;

147
COMBI touch
Delicately brush the surface of the polisher
18
tip under running water (drinking water,
temperature 20°C+/- 2°C), in particular the
SDUWVWKDWDUHGLIÀFXOWWRDFFHVV FDYLWLHV
structured surfaces, etc.) using a brush with
soft nylon bristles;
The polisher tip must be brushed until no
residues can be seen (at least 30 seconds);

EN
Using a 20 ml disposable syringe, inject
19
20 ml of cold demineralised water 3 times
inside the cavity of the polisher tip; x3

148
08 Û CLEANING AND STERILIZATION
K9 WRENCH
Place the K9 wrench in a clean container
20
and add enzymatic detergent solution until
the K9 wrench is covered completely;

EN

Let the K9 wrench soak for 10 minutes at


21
40°C ±2°C. This procedure reduces the
amount of blood, protein and mucous
present on the K9 wrench;

Delicately brush the surface of the K9


22
wrench under running water (drinking
water, temperature 20°C+/- 2°C), in
SDUWLFXODUWKHSDUWVWKDWDUHGLIÀFXOWWR
access ( joint) using a brush with soft nylon
bristles;
The K9 wrench must be brushed until no
residues can be seen (at least 30 seconds);

149
COMBI touch
08.4.2.2 MECHANICAL CLEANING

CAUTION: The following mechanical WARNING: Upon completion


cycle must always be preceded by the pre- of the cleaning cycle in the thermal
washing phase with enzymatic detergent. disinfector, the scaler handpiece remains
NOTE: Make sure that the accessories at the heated washing temperature. Use
are appropriately blocked in the basket appropriate precautions when extracting
and cannot move during washing. Any the scaler handpiece from the thermal
EN movement during washing could damage disinfector to prevent injury to the
operator.
them. Position the instruments in a way
WKDWWKHZDWHUFDQÁRZWKURXJKDOOWKH CAUTION: Due to its shape, the scaler
surfaces, even internally. handpiece can rotate.
CAUTION: Avoid overloading When not in use, the scaler handpiece
the thermal disinfector as this could must always be placed on its support.
compromise cleaning effectiveness.

Place the accessories in a metal basket and


1
place the basket in the thermal disinfector;

Sequence and parameters applicable to


2
the cycle:
- 1 min, rinse with cold water; +
__
- 5 min, wash with alkaline detergent -

at 55°C ±2°C;
- 1 min, neutralisation with suitable
solution (1/3 cold water, 2/3 hot water);
- 1 min, rinse with water (1/3 cold water,
2/3 hot water);
- 5 min, thermal disinfection at 93°C with
demineralised water.
Thermal disinfection has not been tested
experimentally. In compliance with ISO
Procedure validated with Miele PG8535 instrument
15883-1, Table B.1 [4] thermal disinfection washer/disinfector.
at a temperature of 90°C for 5 min Miele DES-VAR-TD program.
Alkaline detergent: neodisher® FA (0.2 % v/v);
determines a value A0 3000. Neutralising liquid: neodisher® Z (0.1 % v/v);

150
08 Û CLEANING AND STERILIZATION
08.4.3 AUTOMATIC CLEANING
MATERIALS NECESSARY
- Alkaline detergent: neodisher® FA CAUTION: Before starting to clean the
(0.2 % v/v); thermal disinfector, assess the entity of
- Neutralising liquid: neodisher® FA dirt and, if necessary, perform a pre-wash
(0.1 % v/v); (paragraph 8.4.2.1) to avoid repeating the
- Water; entire cleaning cycle.
- Metal basket;
- Adaptors;
EN
- Thermal disinfector.

NOTE: Make sure that the accessories WARNING: Upon completion of the
are appropriately blocked in the basket cleaning cycle in the thermal disinfector,
and cannot move during washing. Any the scaler handpiece remains at the heated
contact could damage them. Position the washing temperature. Use appropriate
instruments in a way that the water can precautions when extracting the scaler
ÁRZWKURXJKDOOWKHVXUIDFHVHYHQLQWHUQDO handpiece from the thermal disinfector to
WARNING: Avoid overloading prevent injury to the operator.
the thermal disinfector, as this could CAUTION: Due to its shape, the scaler
compromise cleaning effectiveness. handpiece can rotate. When not in use, the
scaler handpiece must always be placed on
its support.

Position the accessories in a metal basket.


1
Connect the relevant adapter (supplied
as an option) to the scaler handpiece
connector and then to the water jet
cleaning connections of the thermal
disinfector.
Repeat the same operation for the inserts
and polisher tips, connecting them to the
relevant adapters supplied as an optional.

Sequence and parameters applicable to


2
the cycle:
- 1 min, rinse with cold water;
- 5 min, wash with alkaline detergent at
55°C ±2°C;
- 1 min, neutralisation with suitable
solution (1/3 cold water, 2/3 hot water);
- 1 min, rinse with water (1/3 cold water,
2/3 hot water);
- 5 min, thermal disinfection at 93°C with
demineralised water.
Thermal disinfection has not been tested
experimentally. In compliance with ISO
15883-1, Table B.1 [4] thermal disinfection
at a temperature of 90°C for 5 min
determines a value of A0 3000.
151
COMBI touch
08.5 Û CLEANING VERIFICATION
MATERIALS NECESSARY
- Light source;
- Magnifying glass 2.5X.

Once the cleaning operations have been


1
completed, visually inspect the scaler
EN handpiece and scaler front tip under an
adequate source of light, if necessary using
a magnifying glass 2.5X, paying attention
to the details that could conceal dirt
residue (threading, cavities, grooves) and,
if necessary, repeat the cleaning cycle if dirt
is still visible; Finally, check the integrity of
those parts and those elements that could
have deteriorated during use:

Repeat the checks on the other accessories


2
(inserts, insert torque wrenches, polisher
tips, K9 wrench), repeating the cleaning
cycle if necessary.

152
08 Û CLEANING AND STERILIZATION

EN

153
COMBI touch
08.6 Û DRYING AND LUBRICATION
MATERIALS NECESSARY
- Compressed air;
6RIWFORWKZLWKORZÀEUHUHOHDVH
- Medical grade lubricant.

EN Dry all parts of the scaler handpiece and


the scaler front tip well, in particular the
1
electric contacts, by blowing compressed
air;

CAUTION: The scaler handpiece


electric contacts must be dry before
the end of the sterilization cycle, before
connection of the device lead. Always
make sure that the connector electric
contacts are entirely dry; dry them by
blowing compressed air if necessary.

CAUTION: Before starting the 2


sterilization cycle, make sure that the
insert is thoroughly dry both internally
and externally. To do this, blow
compressed air both externally and
through the internal passage hole. This
will prevent the appearance of stains,
streaks on the surface or oxidation inside
the insert.

154
08 Û CLEANING AND STERILIZATION

3 CAUTION: Before starting the


sterilization cycle, make sure that the
polisher tip is thoroughly dry both
internally and externally.
To do this, blow compressed air both
externally and through the internal
passage holes. This will prevent the
appearance of stains, streaks on the
surface or oxidation inside the polisher
tip.
EN
Dry the inserts torque wrench using a soft
4
FORWKZLWKORZÀEUHUHOHDVH

Lubricate the inserts torque wrench with


5
medical-grade lubricants at the point
indicated;

CAUTION: Do not use oil or


silicone-based lubricants.

Dry the K9 wrench using a soft cloth with


6
ORZÀEHUUHOHDVH

155
COMBI touch
08.7 Û STERILIZATION
PREPARATION
Seal the scaler handpiece (without inserts)
1
and the scaler front tip individually,
separately in disposable sterilization bags.

EN

Seal the inserts individually inside a


2
disposable bag for sterilization.
Seal the polisher tips individually inside a
disposable bag for sterilization.

Seal the wrench individually inside a


3
disposable bag for sterilization.

Seal the K9 wrench individually inside a


4
disposable bag for sterilization.

156
08 Û CLEANING AND STERILIZATION
STERILIZATION METHOD
The scaler handpiece and the other CAUTION: Do not sterilize the
accessories that can be sterilized are handpiece with the insert screwed onto it.
manufactured with materials that resist WARNING: Infection control -
a maximum temperature of 135°C for a Parts that can be sterilized - Diligently
maximum time of 20 minutes. remove all residues of organic dirt
Once the scaler handpiece and the other before the sterilization.
accessories that are able to be sterilized
CAUTION: Perform the sterilization
have been put into bags individually,
using a water steam autoclave only. EN
perform the sterilization process in the
Do not use any other sterilization
steam autoclave.
procedure (dry heat, irradiation,
The sterilization process validated by ethylene oxide, gas, low temperature
Mectron S.p.A., in a steam autoclave, plasma, etc.).
guarantees SAL 10-6 by setting the
parameters indicated below: CAUTION: Do not exceed the
allowed load of the steam sterilizer.
Type of cycle: 3 times Pre-vacuum
(min. pressure 60 mBar). WARNING: On completion of the
Minimum sterilization temperature: sterilization cycle in autoclave, the scaler
handpiece remains at the sterilization
132°C (interval 0°C÷ +3°C).
temperature for a long time.
Minimum sterilization time: Use appropriate precautions when
4 minutes. extracting the scaler handpiece from
Minimum drying time: 20 minutes. the autoclave to prevent injury to the
All of the stages of sterilization must be operator.
performed by the operator in compliance CAUTION: Wait for the scaler
with ISO 17665-1:2007, ISO 556-1:2002 and handpiece to cool down completely
ANSI/AAMI ST 46:2002. before use.

157
COMBI touch

09 Û MAINTENANCE
If the device is not used for a prolonged time, 6 &OHDQDQGGU\WKHZDWHUÀOWHU VHH
observe the following recommendations: paragraph 09.2);
1 Empty the powder containers; 7 Before using the device again, clean and
2 Perform a complete cleaning cycle of the sterilize the handpiece and the accessories,
LUULJDWLRQFLUFXLWXVLQJWKH´ÁXVKµIXQFWLRQ following the instructions given in chapter
VHHFKDSWHU´ÁXVKµIXQFWLRQ ERWKRQ 08 - CLEANING AND STERILIZATION;
EN the ULTRASOUND side and the POLISHING 8 Check that the inserts are not worn out,
side; deformed, or broken, placing special
3 Empty the irrigation solution container attention to the integrity of their tip.
irrigation circuits, removing the irrigation
solution container and performing the WARNING: Periodically check that
´ÁXVKµF\FOHRIWKHULTRASOUND side; the electrical power cable is intact; if it
4 Eliminate any condensation from the air is damaged, replace it with an authentic
ÀOWHU VHHSDUDJUDSK  Mectron spare part.
5 Disconnect the device from the mains
electricity and the water and air circuits;

09.1 Û REPLACEMENT OF THE PERISTALTIC PUMP


There is a plastic protection on the left side
1
of the device, which covers the peristaltic
pump housing. Remove this protection by
pressing on the sides and pulling towards
yourself;

CAUTION: Before performing


any kind of service on the peristaltic
pump, make sure that the device is
disconnected from the power outlet
and that the liquid container is not
connected.

Disconnect the two silicon tubes of the


2
peristaltic pump from their respective
couplings, which are positioned beneath
the pump;

158
09 Û MAINTENANCE
Extract the peristaltic pump from its base,
3
pulling it towards yourself. Pay close
attention, as pieces may detach;

EN
Connect the new peristaltic pump to its
4
seat until a “click” sound is heard and then
connect the two pump tubings to their
respective couplings positioned beneath
the pump;

WARNING: Only use authentic


Mectron parts.

Re-position the plastic cover on the


5
peristaltic pump.

159
COMBI touch
09.2 Û CLEANING AND/OR REPLACING THE WATER FILTER
&KHFNDQGFOHDQWKHZDWHUÀOWHUPRQWKO\SHUIRUPLQJWKHIROORZLQJRSHUDWLRQV

Disconnect the water supply pipe from the


1
male coupling.
Unscrew the knurled bush of the male
coupling;

EN CAUTION: Before cleaning and/


RUUHSODFLQJWKHZDWHUÀOWHUPDNHVXUH
that the device is disconnected from
the main electricity and that the liquid
container is not connected.

([WUDFWWKHÀOWHUDQGZDVKLWXQGHUUXQQLQJ
2
water to eliminate the impurities that
obstruct it.

5HLQWURGXFHWKHÀOWHULQWRLWVVHDWDQG
3
screw the knurled bush back into its
housing tightly until it is fully in position.

NOTE: 5HSODFHWKHÀOWHUZLWKDQHZ
one if it is damaged or washing is not
effective.

160
09 Û MAINTENANCE
09.3 Û ELIMINATING CONDENSATION
7KHGHYLFHKDVDQDLUÀOWHUZKLFKLQWHUFHSWVDQ\LPSXULWLHVDQGWKHFRQGHQVDWHSUHVHQWLQWKH
pneumatic circuit.
To prevent the condensation from entering into circulation in the device, check and empty the
DLUÀOWHUZHHNO\E\SHUIRUPLQJWKHIROORZLQJRSHUDWLRQV

Position an absorbent cloth underneath the


1
device to collect the condensate;
EN
CAUTION: This maintenance
operation must be performed with the
appliance on in order for the air circuit
to be pressurised.

With the device on and in an exact


2
KRUL]RQWDOSRVLWLRQSUHVVWKHDLUÀOWHUYHQW
valve positioned on the bottom of the
device, just until air escapes.

NOTE: However, it is recommended


to use dry compressors and introduce
DGHKXPLGLÀHULQWRWKHSUDFWLFH·V
pneumatic circuit.

161
COMBI touch
09.4 Û CLEANING POWDER CONTAINERS AND CAPS
Check cleanliness of the powder container and, in particular, the cap as powder residues in the
SUHVHQFHRIPRLVWXUHFRXOGVROLGLI\DQGPDNHRSHQLQJDQGFORVLQJRSHUDWLRQVGLIÀFXOW

CAUTION: Always switch the device 1


off using the I/O switch and disconnect
it from the mains electricity before
EN cleaning the powder containers and the
caps.
WARNING: Before blowing
compressed air into the powder
containers, make sure that they have
been emptied.
Blow compressed air inside the container
and on the threading of both the powder
containers and the caps.

When the cleaning operation has been


2
completed, re-position the containers on
the device.

CAUTION: Insert the powder


containers in a way that the grooves on
the bottom of the device are in line with
the convexity of the powder containers.

10 Û DISPOSAL MODES AND PRECAUTIONS


WARNING: Hospital wastes. The COMBI touch must be disposed of and
Treat the following items as hospital waste: treated as a waste for separate collection.
- Inserts: when they are worn out or Disregarding the previous points may entail a
broken; ÀQHSXUVXDQWWR'LUHFWLYH8(
- Torque wrench for inserts: when worn It is up to the purchaser to hand over the
out or broken. device for its disposal to the retailer who
- Cleaner terminals, when worn or broken; supplies them with new equipment; the
- Perio subgingival terminal, at the end of instructions for proper disposal are available
each treatment. from Mectron.

The use and disposal of materials, and


materials that entail a biological risk, must
be disposed of in accordance to the local
regulations in force concerning hospital
wastes.

162
11 Û TECHNICAL DATA

11 Û TECHNICAL DATA
Device compliant to Dir. 9342CEE: Class IIa
ClassiÀcation as per EN 60601-1: I
Applied part type B (handpiece, insert)
IP 20 (device)
IP 22 (foot pedal)
Essential performance: According to the standard IEC 80601-2-60 the device EN
has no essential performance.
Apparecchio per funzionamento 55sec. ON - 30sec. OFF with irrigation
intermittente: (ULTRASOUND function and POLISHING function)
30 sec. ON - 120sec. OFF without irrigation
(mode: “endo” and “perio/scaler” power from 1 to 5,
“restorative” power from 1 to 4).
Power supply voltage: 100-240 V 50/60 Hz
Max. power absorbed: 90 VA
Fuses: Type 5 x 20 mm T 2AL, 250V
Water supply: Working pressure from 1 to 6 bar.
Cleaning function of the polishing part
and scaler water circuit - See Chapter 06.
Connection via the pipe supplied
with quick coupling through a built-in
 DQGUHPRYDEOHÀOWHU
Air supply: Inlet pressure between 4 and 8 bar.
Air circuit cleaning function - See 09.3
Connection via pipe supplied
 ZLWKTXLFNFRXSOLQJWKURXJKDÀOWHU
and built-in pressure reducer.
Operating conditions: from +10°C to +35°C
Relative humidity from 30% to 75%
Pressure of air P: 800hPa/1060hPa
Transport and storage conditions: from -10°C to +70°C
Relative humidity from 10% to 90%
Pressure of air P: 500hPa/1060hPa
Weights and sizes: 4.8 Kg
L-W-H 410 x 260 x 145 mm

163
COMBI touch

Parte ULTRASOUND
Operating frequency: Automatic scan
From 24 KHz to 36 KHz
Tipi Potenze ((mode): “endo”
“perio/scaler”
“restorative”
“soft mode”
EN Power Levels: from 1 to 5
Peristaltic pump capacity: Adjustable
j on the touch screen
 ÁRZOHYHOV
ÁRZOHYHOV
from 0 ((0 ml/min)) to 6 ((circa 30 ml/min)
(see Paragraph 05.2 - IRRIGATION)
LED system of the handpiece: Light
g function on AUTO: LED system y of the
handpiece
p switches on as soon as the device starts
to operate
p and switches off 3 seconds after the foot
pedal is released
Light
g function on ON: The LED of the handpiece p is
y on; after 100 seconds of foot p
always pedal disuse, it
switches off byy itself and the light function moves
into position AUTO
Light
g Function on OFF: The LED of the handpiece is
always off.f
Protections of the APC circuit: No handpiece detected
Cord interruption
Insert not tightened correctly or broken

POLISHING part
Polisher Function: Can be selected via touch screen:
“Prophy” function - “Perio” function
Irrigation: Continuous regulation via knob.
Water heated via heating element.

164
11 Û TECHNICAL DATA
11.1 Û ELECTROMAGNETIC COMPATIBILITY EN 60601-1-2
WARNING: Interference with other WARNING: Interference from other
equipment. Though compliant with the equipment. An electrical scalpel or other
standard IEC 60601-1-2, the COMBI touch electro-surgical units near the COMBI
may nonetheless interfere with other touch device may interfere with its correct
devices nearby. operation.
The COMBI touch must not be used near WARNING: The device requires
or stacked on other devices. However,
if this is necessary, you must check and
VSHFLÀF(0&SUHFDXWLRQVDQGPXVWEH
installed and activated in accordance
EN
monitor the correct operation of the with the EMC information given in this
GHYLFHLQWKDWFRQÀJXUDWLRQ paragraph.
WARNING: Portable and mobile radio
communication devices may affect the
correct functioning of the device.

Guidance and manufacturer’s declaration - Electromagnetic emissions


The COMBI touchLVLQWHQGHGIRUXVHLQWKHHOHFWURPDJQHWLFHQYLURQPHQWVSHFLÀHG
below. The customer or user of the COMBI touch should ensure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment – Guidance

RF emissions Group 1 The COMBI touch only uses RF energy for


CISPR 11 internal function. Therefore, its FR emissions
are very low and are not likely to cause any
interference with nearby electronic
equipment.

RF emissions Class B The COMBI touch is suitable for use in


CISPR 11 all establishments, including domestic
establishments and those directly connected
Harmonic emissions Class A to the public low-voltage power supply
IEC 61000-3-2 network that supplies buildings used for
domestic purposes.
9ROWDJHÁXFWXDWLRQV Complies
ÁLFNHUHPLVVLRQV
IEC 61000-3-3

165
COMBI touch

Guidance and manufacturer’s declaration - Electromagnetic immunity


The COMBI touchLVLQWHQGHGIRUXVHLQWKHHOHFWURPDJQHWLFHQYLURQPHQWVSHFLÀHG
below. The customer or user of the COMBI touch should ensure that it is used in such an
environment.
Immunity Test level Compliance Electromagnetic
test IEC 60601 level environment - Guidance
Electrostatic ±6 kV contact The device continues Floors should be wood,
EN discharge (ESD) ±8 kV air to work regularly and concrete or ceramic tile.
IEC 61000-4-2 in safety ,IÁRRUVDUHFRYHUHGZLWK
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast ±2 kV for power The device continues Main power quality
transient/burst supply lines to work regularly and should be that of a
IEC 61000-4-4 in safety typical commercial or
±1 kV for input/ hospital environment.
output lines
Surge ±1 kV differential The device continues Main power quality
IEC 61000-4-5 mode to work regularly and should be that of a
in safety typical commercial or
±2 kV common mode hospital environment.
Voltage dips, short <5 % UT (>95 % dip The device can vary Main power quality
interruptions and in UT) for 0,5 cycles from the required should be that of a
voltage variations levels of immunity typical commercial or
on power supply 40 % UT (60 % dip with a duration of hospital environment.
input lines in UT) for 5 cycles <5% / >95% / 5 s as
IEC 61000-4-11 long as the device
70 % UT (30 % dip remains in safety, no
in UT) for 25 cycles malfunctions have
been detected and
<5 % UT can be restored to
(>95 % dip in UT) pre-test status with
for 5 s the intervention of
the operator
Power frequency 3 A/m The device continues Power frequency
(50/60 Hz) to work regularly and PDJQHWLFÀHOGVVKRXOG
PDJQHWLFÀHOG in safety be at levels characteristic
IEC 61000-4-8 of a typical location in a
commercial or hospital
environment.
N.B.: UT is the AC mains voltage prior to application of the test level.

166
11 Û TECHNICAL DATA

Guidance and manufacturer’s declaration - Electromagnetic immunity


The COMBI touchLVLQWHQGHGIRUXVHLQWKHHOHFWURPDJQHWLFHQYLURQPHQWVSHFLÀHGEHORZ
The customer or user of the COMBI touch should ensure that it is used in such an
environment.
Immunity Test level Compliance Electromagnetic environment
test IEC 60601 level Guidance
Portable and mobile RF
communications equipment should EN
be used no closer to any part of the
device including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.

Conducted RF 3 Veff The device Recommended separation distance


IEC 61000-4-6 from 150 kHz continues to G ¦3
to 80 MHz work regularly
and in safety
Radiated RF 3 V/m G ¦3IURP0+]WR0+]
IEC 61000-4-3 from 80 MHz G ¦3IURP0+]WR*+]
to 2,5 GHz
where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in metres (m).
)LHOGVWUHQJWKVIURPÀ[HG5)
transmitters, as determined by an
electromagnetic site surveya, may
be less than the compliance level in
each frequency rangeb.
Interference may occur in the vicinity
of equipment marked with the
following symbol:

N.B.:
(1) at 80 MHz and 800 MHz, the higher frequency range applies.
(2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
UHÁHFWLRQIURPVWUXFWXUHVREMHFWVDQGSHRSOH
D )LHOGVWUHQJWKVIURPÀ[HGWUDQVPLWWHUVVXFKDVEDVHVWDWLRQVIRUUDGLR FHOOXODUFRUGOHVV WHOHSKRQHVDQGODQG
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
ZLWKDQ\UHDVRQDEOHDFFXUDF\7RDVVHVVWKHHOHFWURPDJQHWLFHQYLURQPHQWGXHWRÀ[HG5)WUDQVPLWWHUVDQ
HOHFWURPDJQHWLFVLWHVXUYH\VKRXOGEHFRQVLGHUHG,IWKHPHDVXUHGÀHOGVWUHQJWKLQWKHORFDWLRQLQZKLFK
the COMBI touch is used exceeds the applicable RF compliance level given above, the COMBI touch should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the COMBI touch.
E 2YHUWKHIUHTXHQF\UDQJHIURPN+]WR0+]ÀHOGVWUHQJWKVVKRXOGEHOHVVWKDQ9P

167
COMBI touch

Recommended separation distances between portable and mobile RF


communications equipment and the COMBI touch
The COMBI touch is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or user of the COMBI touch can
help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile FR communications equipment (transmitters) and the COMBI touch
as recommended below, according to the maximum output power of the communications
EN equipment.
Rated maximum Separation distance according to the frequency of transmitter ‘m’
output power
of transmitter from 150 kHz to 80 MHz from 80 MHz to 800 MHz from 800 MHz to 2,5 GHz
‘W’ G ¦3 G ¦3 G ¦3

0,01 0,12 0,12 0,23


0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be calculated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
N.B.:
(1) at 80 MHz and 800 MHz, the higher frequency range applies.
(2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
UHÁHFWLRQIURPVWUXFWXUHVREMHFWVDQGSHRSOH

168
12 Û TROUBLESHOOTING

12 Û TROUBLESHOOTING
12.1 Û DIAGNOSTIC SYSTEM AND SYMBOLS ON KEYBOARD
The COMBI touch is equipped with a diagnostic circuit that allows for the detection of
operating abnormalities and to view their type on the touch surface via their relative symbol.
%\XVLQJWKHIROORZLQJFKDUWWKHXVHULVJXLGHGWRZDUGWKHLGHQWLÀFDWLRQDQGSRVVLEOHVROXWLRQ
of the malfunction detected.
EN
Symbols Possible cause Solution
on keyboard
Handpiece electric contacts/lead wet. Thoroughly dry the contacts with
compressed air (See paragraph 08.6).
COMBI touch handpiece not connected Connect the handpiece
to device. (See paragraph 04.3).
Scaler handpiece failure. Replace the handpiece.
Sync circuit malfunction. Contact an Authorized Mectron Service
Center.
Insert not tightened correctly on Unscrew the insert and correctly screw it
handpiece. on again with the Mectron torque wrench
(See paragraph 05.4).
Insert broken, worn-out or deformed. Replace the insert.
Handpiece/cord contacts wet. Throughly dry the contacts with
compressed air (See paragraph 08.6).
Turn-on procedure incorrect: the device Check that the foot pedal is not depressed.
has been turned on with the foot pedal If the problem persists, disconnect
depressed. the pedal and, if need be, contact an
Authorized Mectron Service Center.
Peristaltic pump malfunction. Check that there are no impediments to
pump rotation.
Check that the peristaltic pump
and the pipes are installed correctly.
(See paragraph 09.1).
The device has been turned off and on Turn device off and wait 5 seconds before
again without waiting 5 seconds. turning it on again.
Abnormalities on electrical network or Turn device off and wait 5 seconds before
excessive electrostatic discharges or turning it on again
internal abnormalities. If the signal persists, contact an
Authorized Mectron Service Center.
A powder container has been opened Before opening one of the powder
ZLWKRXWSHUIRUPLQJWKH´UHÀOOµF\FOH FRQWDLQHUVWKH´UHÀOOµF\FOHPXVWEH
performed (See paragraph 05.7).

One of the powder containers has Before removing one of the powder
been removed from its seat without FRQWDLQHUVWKH´UHÀOOµF\FOHPXVWEH
SHUIRUPLQJWKH´UHÀOOµF\FOH performed (See paragraph 05.7).
The selected powder container is not Correctly insert the powder containers
correctly inserted in place. to the furthest point possible.

169
COMBI touch
12.2 Û QUICK SOLUTION TO PROBLEMS

Problem Possible cause Solution


The electrical power cable Check that the power supply
terminal is poorly inserted in FDEOHLVÀUPO\FRQQHFWHG
the rear plug of the device.
The device does not
EN turn on after having The electrical power cable is Check that the power supply
brought the switch into defective. socket works properly.
position ´Iµ Replace the electrical power
cable.
The fuses are out of order. Replace the fuses
(See paragraph 12.3).
The foot pedal plug is Correctly insert the pedal
The device is on incorrectly inserted in the plug in the socket on the
but not working. device socket. back of the device
There are no (See paragraph 04.3).
anomalies signalled on
the keyboard The foot pedal does not work. Contact an Authorized Mectron
Service Center.
The device is on See paragraph 12.1 for the See paragraph 12.1 for the
but not working. possible cause, according action to be undertaken,
One of the following to the symbol that has been according to the symbol that
symbols appears displayed. has been displayed.
on the screen:

The insert is not correctly Unscrew and correctly screw


A slight whistling tightened on the handpiece. the insert on again with the
sound coming from Mectron torque wrench
the COMBI touch (See paragraph 05.4).
handpiece
is heard The irrigation circuit has not Fill the irrigation circuit via
during operation EHHQFRPSOHWHO\ÀOOHG WKHIXQFWLRQ´ÁXVKµ
(See paragraph 05.4).

The pump turns The peristaltic pump is worn. Replace the peristaltic pump
correctly but when (See paragraph 09.1).
it stops, liquid
escapes from
the handpiece

By pressing the foot THE foot pedal has been Lift the handpiece to be used
pedal, a prolonged depressed with both before depressing the pedal.
signal is emitted and handpieces at rest.
the ULTRASOUND and
POLISHING function
LEDs Áash

170
12 Û TROUBLESHOOTING

Problem Possible cause Solution


The insert is not correctly Unscrew and correctly screw
tightened on the handpiece. the insert on again with the
Mectron torque wrench
(See paragraph 05.4).
InsufÀcient
performance
Insert broken, worn-out Replace the insert with a new EN
or deformed. one.
,QVXIÀFLHQWRUH[FHVVLYH Correct level of powder
powder level in the container. in the container
(See paragraph 04).
Device not connected to the Check the connection
water circuit. to the water circuit
(See paragraph 04.3).
The insert is the “Irrigation free” Use an insert that envisions the
type and therefore does not passage of liquid.
envision the passage of liquid.
The insert is obstructed. Unscrew the insert from the
handpiece and free the insert
water passage by blowing
compressed through it.
If the problem persists, replace
the insert with a new one.
The handpiece is obstructed. Contact an Authorized Mectron
No liquid outÁows Service Center.
from the insert during Irrigation is disabled. Activate irrigation and regulate
operation the level of irrigation
(See paragraph 05.2.1).
The water tap on the device 5HJXODWHWKHÁRZRIZDWHU
is closed. using the knob dedicated to the
function used.
:DWHUÀOWHUFORJJHG See paragraph 09.2.
The irrigation solution Fill the irrigation solution
container is empty. container.
The irrigation solution container Connect the irrigation solution
is not installed correctly. container to the device body
correctly.

The silicon tubings of the Unscrew and correctly screw


pump are incorrectly installed. the insert on again with the
Mectron torque wrench
(See paragraph 09.1).

The perisltatic pump is Replace the insert with


over-used. a new one
(See paragraph 09.1).

171
COMBI touch

Problem Possible cause Solution


Device not connected to the air Check the connection
circuit. to the air circuit
(See paragraph 04.3).
Polisher tip blocked due an See Chapter 09.
excessive amount of moisture
LQWKHSRZGHURULQVXIÀFLHQW
cleaning/maintenance.
EN During
operation powder Cleaner handpiece channel See paragraph 08.1.
does not escape clogged due to an excessive
from the amount of moisture in the powder
polisher tip RULQVXIÀFLHQWFOHDQLQJ
The level of powder in the Remove the powder from the
container exceeds the maximum container and clean it using
allowed. a dry cloth. Correct level of
powder in the container.
(See Chapter 04).
Unsuitable powder. Use the correct powder for
correct device operation.

Loss of powder Cap not correctly tightened. Screw the cap correctly.
through Powder residues in the threading. Clean the threading of the
the powder powder container
container cap (See paragraph 09.4).
,QVXIÀFLHQWSUHVVXUHLQWKHDLU Check air supply circuit
supply circuit. pressure (4-8 bar max).
,QVXIÀFLHQWRUH[FHVVLYHSRZGHU Correct level of powder in
level in the container. the container.
InsufÀcient Unsuitable powder. Check the correct powder for
cleanliness correct device operation.
Polisher tip blocked due an Remove the powder
excessive amount of moisture from the container and
LQWKHSRZGHURULQVXIÀFLHQW clean it using a dry cloth.
cleaning/maintenance.

The device is on and the powder 3HUIRUPWKH´UHÀOOµF\FOH


container is pressurised. before opening one of the
powder containers
(See paragraph 05.7).
7KH´UHÀOOµF\FOHKDVEHHQ Read the part concerning
One of the performed but the powder cleaning the polisher tip
powder container caps containers have remained (See Chapter 08).
does not unscrew pressurised because the polisher
tip is clogged.
7KH´UHÀOOµF\FOHKDVEHHQ Contact a Mectron-
performed but the powder Authorised After-sales
containers have remained Assistance Centre.
pressurised because the polisher
lead is clogged.

172
12 Û TROUBLESHOOTING
12.3 Û REPLACEMENT OF THE FUSES
WARNING: Switch the device off.
Always turn the device off with the
main switch and disconnect it from
the electrical power socket before
performing the following procedure.

1
$SSO\OHYHUDJHZLWKDÁDWVFUHZGULYHU EN
inserting its tip in the seat of the fuse-
holder drawer located under the power
supply socket;

Pull out the fuse-holder drawer;


2
WARNING: Replace the fuses,
complying with the characteristics
indicated in Chapter 11 - TECHNICAL
DATA.

Reinsert the drawer in its housing.


3

173
COMBI touch
12.4 Û SENDING THE DEVICE TO AN AUTHORISED
MECTRON SERVICE CENTER
In the event that technical assistance is The device must be returned properly
needed on the device, contact one of the packaged, accompanied by all the
Authorized Mectron Service Centers or your accessories, and by a document be aring the:
Retailer. Do not attempt to repair or modify ‡2ZQHULQIRUPDWLRQLQFOXGLQJFRPSOHWH
the device and its accessories. address and telephone number

EN Clean and sterilize all the parts that need


to be sent to an Authorized Mectron
‡3URGXFWQDPH
‡6HULDOQXPEHUDQGRUORWQXPEHU
Service Center, following the instructions ‡5HDVRQIRUJRRGVUHWXUQHGGHVFULSWLRQRI
provided in the Chapter 08 - CLEANING AND the malfunction
STERILIZATION. ‡3KRWRFRS\RISDFNLQJOLVWRUSXUFKDVH
Return all parts in sterilization pouches to invoice of the device
provide evidence that the sterilization process
has been performed. CAUTION: Package
Pack the device in its original packaging to
The cleaning and sterilization requirements prevent damages during transport.
are in line with those in force concerning
the safeguarding of health and safety in the Once the material has been received by
workplace, as per Law Decree 626/94 and the Authorized Mectron Service Center,
DLgs 81/08 and its subsequent amendments, TXDOLÀHGWHFKQLFDOSHUVRQQHOZLOOSURYLGHDQ
both laws of the Italian State. evaluation based on the given circumstances.
,QWKHHYHQWWKDWFXVWRPHUGRHVQRWIXOÀOO The repair work will be performed only upon
the requirements, Mectron reserves the right the prior acceptance by the customer. For
to charge him or her for the cleaning and further details, contact the closest Authorized
sterilization expenses, or to reject the goods Mectron Service Center or your retailer.
received in unsuitable conditions, returning Unauthorized repair works may damage the
them to the customer, at the customer’s system and make the warranty void, and will
expense, for them to be correctly cleaned and absolve Mectron of any responsibility for
sterilized. direct or indirect harm to persons or damages
to anything else.

174
13 Û WARRANTY

13 Û WARRANTY
All Mectron devices are subjected to an - The assembly operations, extensions,
accurate end inspection that ascertains their adjustments, updates, and repair works are
full functionality before they are placed on performed by personnel not authorized by
the market. Mectron.
Mectron provides a warranty on all new - The environmental conditions for the
COMBI touch purchased from a retailer or
a Mectron importer to cover material or
preservation and storage of the device are
not compliant to the precautions indicated
EN
manufacturing defects for: in the Chapter 11 - TECHNICAL DATA.
- 2 YEARS (TWO) on the device from the date - Use of non-authentic Mectron inserts,
of purchase; accessories, and spare parts that can
- 1 YEAR (ONE) on the handpiece from the compromise correct device operation and
date of purchase. cause harm to the patient.
The accessories are not included in the - Accidental breakage due to transport
warranty. - Damages due to incorrect use or
During the period in which the warranty is negligence, or to connection to a power
valid, Mectron commits itself to repair (or at voltage other than the one required
its own free choice, replace) those product - Warranty expiration
parts that were to proved defective according
to its judgment, free of charge.
Entire replacement of the Mectron products PLEASE NOTE The warranty is valid only if
is excluded. the warranty sheet annexed to the product
KDVEHHQÀOOHGRXWLQDOOLWVSDUWVDQGVHQW
The warranty of the manufacturer and the WRRXURIÀFHVRUSRVVLEO\WRWKHUHWDLOHURU
FHUWLÀFDWLRQRIWKHGHYLFHDUHQRWYDOLGLQWKH Mectron importer within 20 (twenty) days
following cases: from the date of purchase, which is the date
- The device is not used in accordance to its that appears on the packing list/purchase
intended use. invoice issued by the retailer/importer.
7REHQHÀWIURPWKHZDUUDQW\VHUYLFHWKH
- The device is not used in compliance with customer must return, at its own expense, the
all of the instructions and precautions device to be repaired to the retailer/Mectron
described and outlined in this manual. importer from whom the customer purchased
- The electrical system located at the in the product.
which the device is used is not compliant to
electrical code compliance standards and to See paragraph 12.4 for the details relative
the relative precautions. to the procedure to send the device to an
Authorized Mectron Service Center.

7KHLQGLFDWLRQVWKDWDSSHDULQWKLVSXEOLFDWLRQDUHQRWELQGLQJDQGFDQEHPRGLÀHGZLWKRXWIRUHQRWLFH
The Italian version of this manual is the original document from which its translations have been obtained. In case of any
discrepancy, the Italian version will have pertinence.

Texts, images, and graphics of this manual are property of Mectron S.p.A., Carasco, Italy. All rights reserved.
The contents cannot be copied, distributed, changed, or made available to third parties without the written approval of
Mectron S.p.A.

175

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