Mectron COMBI Touch Manual
Mectron COMBI Touch Manual
MULTIPIEZO
PRO
COMBI touch
08 J
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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
90
COMBI touch
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
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
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.
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
96
01 Û INTRODUCTION
01.5 Û SYMBOLS
Serial number
Lot number
Product code
Operating instructions
EN
Use-by date
-10 °C
Temperature limitation - transport and storage conditions
90 %
500 hPa
Atmospheric pressure limitation - transport and storage conditions
Manufacturer
Date of Manufacture
Non-sterile
Biohazard
I Activation switch “on”
0 Activation switch “off”
Alternating current
Connection of the foot pedal
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
Rx only
0476
98
02 Û IDENTIFICATION DATA
3 4 5
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
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.
102
04 Û INSTALLATION
Unscrew the cap from the irrigation
5
VROXWLRQFRQWDLQHUDQGÀOOLQWKHLUULJDWLRQ
solution container with the needed
solution;
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;
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.
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).
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.
´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.
108
05 Û USE
IRRIGATION
refill
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.
´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
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
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:
NOT CORRECT
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.
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:
117
COMBI touch
EN
Insert the front subgingival tip onto the
4
PERIO polisher tip, pushing it fully home.
reached.
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
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
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
refill
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
123
COMBI touch
POLISHING - Polishing side
EN
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;
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
refill
125
COMBI touch
126
07 Û DISASSEMBLY
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;
127
COMBI touch
128
08 Û CLEANING AND STERILIZATION
I 08.1 Preparation
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
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).
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);
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.
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
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;
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;
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
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;
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;
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;
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
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
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;
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.
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
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;
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
8VLQJDPOGLVSRVDEOHV\ULQJHÁXVKWKH
13
surface of the wrench 3 times with 20 ml of
enzymatic detergent solution; x3
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;
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
149
COMBI touch
08.4.2.2 MECHANICAL CLEANING
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.
152
08 Û CLEANING AND STERILIZATION
EN
153
COMBI touch
08.6 Û DRYING AND LUBRICATION
MATERIALS NECESSARY
- Compressed air;
6RIWFORWKZLWKORZÀEUHUHOHDVH
- Medical grade lubricant.
154
08 Û CLEANING AND STERILIZATION
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
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;
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;
159
COMBI touch
09.2 Û CLEANING AND/OR REPLACING THE WATER FILTER
&KHFNDQGFOHDQWKHZDWHUÀOWHUPRQWKO\SHUIRUPLQJWKHIROORZLQJRSHUDWLRQV
([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
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
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.
165
COMBI touch
166
11 Û TECHNICAL DATA
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
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
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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
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
171
COMBI touch
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.
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;
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
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.
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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