Manuais - 72670 - Ultrasonic Duo
Manuais - 72670 - Ultrasonic Duo
Brand: Gnatus
Manufacturer/ Distribuitor:
GNATUS - EQUIPAMENTOS MÉDICO-ODONTOLÓGICOS LTDA.
Rod. Abrão Assed , Km 53+450m - Cx. Postal 782 CEP 14097-500
Ribeirão Preto - S.P. - Brasil
Fone +55 (16) 2102-5000 - Fax +55 (16) 2102-5001
C.N.P.J. 48.015.119/0001-64 - Insc. Est. 582.329.957.115
www.gnatus.com.br - [email protected]
Technical Duties: Gilberto Henrique Canesin Nomelini
CREA-SP: 0600891412
ATTENTION
For greater safety:
Read and understand all the instructions contained in these
Instructions for Use before installing or operating this Equipment.
Note: These Instructions for Use must be read by all the operators
of this Equipment.
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INDEX
PRESENTATION OF MANUAL .........................................................................02
IDENTIFICATION OF EQUIPMENT..................................................................04
TECHNICAL SPECIFICATIONS........................................................................10
- Technical characteristics..................................................................................10
- Standards applied..........................................................................................12
- Dimension.....................................................................................................15
- Symbologies of packaging...............................................................................17
- Symbologies of product...................................................................................17
- Contents of the accessible and inaccessible markings..........................................18
INSTALLATION OF EQUIPMENT.....................................................................19
OPERATION OF EQUIPMENT..........................................................................21
- Turning on / Turning of the appliance................................................................21
- “Scaler” applications and techniques.................................................................24
WARRANTY OF EQUIPMENT...........................................................................34
FINAL CONSIDERATIONS...............................................................................34
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IDENTIFICATION of the Equipment
Dear Customer
Congratulations. You have made a good choice when you decided to buy a GNATUS
QUALITY product comparable to the best products available in the World. This manual is a
general presentation of your product and it will give you important details to help you to
solve possible problems.
Please, read it and keep this with you.
Identification
Technical Name: Equipment for prophylaxis and photopolymerization
Brand: Gnatus
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IDENTIFICATION of the Equipment
Description of the Equipment
Equipment for prophylaxis and photopolymerization, with a modern and bold design
incorporated into a single product consisting of Ultrasound and Photopolymerizator with LED
light.
Body and lid made out of ABS (Acrylonitrile, butadiene, styrene) and digital control panel
made out of polycarbonate. Available in the cart and bench models.
It has a Piezoelectric scaler activated through ceramic tablets at a frequency of 30,000
Hz. The Piezoelectric system of the transducer allows the use in operations without the use
of water.
Cover of the transducer made out of rigid and autoclavable thermoplastic resin.
Potentiometer with a fine adjustment for precise adjustment of the ultrasonic power,
suited to each type of procedure.
Foot control for activation.
WORKING APPLICATION
• Distartarization • Amalgam condensation
• Endodonty • Inlays - onlays condensation
• Periodonty • Gutta Percha Condensation
• Micro-recto surgery • Pines and crown removal
The photopolymerization is the latest generation of the appliances of photoactivation
by LED light. This short name is the acronym for Light Emitting Diode, a totally different
manner of emitting light, when compared with the conventional appliances of halogen light.
As opposed to the traditional appliances, which generate light in a wide wave spectrum with
great heat, this technology allows a cold light to be emitted, in the precise wavelength for
activating the different dental products to which it applies.
LED technology, recently introduced in Dentistry, has brought countless advantages
to the curing light appliances for direct restorations in composite resin. Besides being
infinitely more durable, the LEDs have made the appliances more compact, ergonomic and
easy to install and transport. The emission of cold light at a precise wavelength ensures
the polymerization of composites activated by the canforoquinone, without risks of dental
heating, pulpal injury or discomfort for operator and patients.
Heating, pulpal injury or discomfort for operator and patients.
The safety and efficiency of the LEDs, now with high emission power, are available for
all the clinical procedures which require power of light for photoactivation.
The wavelength of 420nm - 480nm associated with the high power emitted by the
photopolymerizator makes the multifunctionality of this appliance feasible:
• Direct restoring procedures: composite resins, ionomers and adhesives.
• Indirect restorations: adhesive cementing of laminates, inlays, esthetic pegs and
metal-free crowns.
• Activation of photoactivated materials as sealers, surgical cements and lining
bases.
Planned and built using cutting-edge technology, to provide results within the specifications
stipulated by the leading world dental authorities.
Digital control in the display on the handpiece itself.
Variance of choice of operating time (5,10,15 and 20 seconds).
It has 3 application modes: Continuous, Ramp and Pulsating:
• Continuous: Maximum and continuous mode of light intensity (same luminosity from
start to finish of the polymerization).
• Ramp: Gradual mode of light intensity; it increases gradually.
• Pulsed: Pulsing mode consisting of cycles which oscillate at a fixed frequency.
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Indication of Equipment
Physical principle used by the equipment
The equipment consists of: ultrasound and photopolymerizator with the following physical
principles:
• Ultrasound: The scaler is derived from physical vibrations of particles of material,
similar to sound waves, with a frequency exceeding the level of human perception, which
produce a frequency up to 30,000 vibrations per second.
• Photopolymerizator: The physical principle is the emission of a cold light to polymerize
photosensitive substances, as the equipment is endowed with a cold light emitter (LED) with
a wavelength between 420 and 480nm (blue light), which has an ideal intensity for being
integrated with the canforoquinone.
Indication of Equipment
This equipment is for dental use use only. It must be operated and utilized by specialized
professional (certified professional, according to the legislation of the country) and following
the instructions of the manual.
The operation of the equipment required, for the professional, the utilization of
correct instruments and it should to be in perfect conditions of the use, and to protect the
professional, the patients and others, in the eventual danger situation.
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MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF
CONSUMPTION
ULTRASONIC DUO
08
09
07
03
02
06
01 04 05
01 - On/off key
02 - Regulator of sonic variation
03 - Water flux regulator
04- Ultrasound hand piece
05 - Support of the points
06 - Actuation pedal
07 - Electrical cable
08 - Photopolymerizator hand piece
09 - LED indication of “charger” photopolymerizator This equipment is also
available in the Cart
version (optional).
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MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF
CONSUMPTION
PHOTOPOLYMERIZATOR
12
11
15
10
16
17
13
14
10 - Light Conductor
11 - Light Protection Shield
12 - Application mode: Continuous, Ramp and Pulsed
13 - Control Panel
14 - Button to turn on the equipment and activate / interrupt operation
15 - Display Window
16 - Time adjustment button
17 - Application mode selection button
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MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION
INSERT Nº 1 INSERT Nº 2
INSERT Nº H-3
INSERT Nº 10P
(optional)
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MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION
TECHNICAL SPECIFICATIONS
General
Model
Ultrasonic Duo
Classification of Equipment as per ANVISA:
Class II
Classification of Equipment as per standard IEC 60601-1:
Protection against Electric Shock - Type B and Class II Equipment (IEC 60601-1)
Protection against harmful water penetration
IPX 0
Mode of Operation
Continuous operation with intermittent load - 10min. work and 10min. rest.
Frequency of scaler
30.000 Hz
Transducer system
Piezoelectric ceramic
10
TECHNICAL SPECIFICATIONS
Power Supply
Power Supply Voltage (Selectable)
127V~ ± 20% / 220V~ + 20%
- 10%
Frequency
50/60 Hz
Fuse
1 A - (127/220V~)
Power
60 VA
Consumed
0,43 A
Other Specifications
Net Weight Ultrasonic Duo : 3,10 kg
Gross Weight Ultrasonic Duo : 3,90 kg
Water inlet pressure
Maximum = 40PSI
Minimum = 20PSI
Photopolymerizator
Light Source
1 LED.
Power light
1200 mW/cm2 ± 200 mW/cm2
Semicondutor Led (InGaN).
Wavelength
420nm - 480nm.
Timer
5,10,15 e 20 seconds.
Time Sounder
a “beep” every 05 s
Activation
Through the handpiece button.
1111
TECHNICAL SPECIFICATIONS
Light Conductor
Optics fiber 100% coherent which guarantees the passage of light without loss.
Handpiece body
Injected in ABS
Weight of the handpiece with light protection shield and light conductor
0,159 kg.
Degree of saf ety of application in the presence of an anesthetic mixture inf
lammable with air, oxygen or nitrous oxide
It is not suitable
Mode of operation
Continuous with intermittent load, 20 s of work with a rest of 20 s
Battery of Li-ion
DC 3,7 V / 2200 mAh.
Approximate time for recharging battery
3h
Standards applied
IEC 60601-1:2005 – Electromedical Equipment - Part 1: General prescriptions for safety;
EN ISO 980:2008 (Ed. 2) - Graphical symbols for use in the labelling of medical devices;
EN ISO 14971:2007 - Medical devices - application of risk management medical devices;
NBR ISO 9687: 2005 - Dental equipment - graphical symbols;
ISO 7494:2004 - Norma dental units;
EN ISO 13485-2003 - Quality systems - medical devices;
ISO 780:1997 - Packaging - pictorial marking for handling goods;
ISO 11144:1995 - Normal dental equipment - connections for supply and waste lines;
IEC 60601-1:2007 – Electromagnetic Compatibility.
After full charge the battery the device supports 300 shots at full power
(1200 mW/cm²).
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TECHNICAL SPECIFICATIONS
13
13
TECHNICAL SPECIFICATIONS
14
TECHNICAL SPECIFICATIONS
Dimensions (mm)
Ultrasonic Duo
15
15
TECHNICAL SPECIFICATIONS
Dimensions (mm)
Ultrasonic Duo Cart (optional)
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TECHNICAL SPECIFICATIONS
Packing symbols
It determines the maximum
Packing to be transported and
quantity of boxes which can be
/ or stored avoiding humidity,
stacked during transportation
rains and wet floor.
and storage “as per packaging”.
Product symbols
Careful : It indi cates an
important instruction for the
Indicated key of ultrasound operation of the product. Not
function. following it can cause dangerous
malfunctioning.
Important: It indicates an
instruction of safety for operation
Water flow adjustment
of the product. Not following it,
button.
can lead to serious danger to
the patient.
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TECHNICAL SPECIFICATIONS
Content of accessible and non-accessible demarcations
INSTALLATION OF EQUIPMENT
The installation of this equipment requires specialized technical
assistance (Gnatus).
- This equipment shall only be able to be unpacked and installed by a Gnatus authorized
technician, under penalty of losing the warranty, as only (s)he has the information, suitable
tools and training required to execute this task.
- Only after the equipment has been installed and duly tested by the authorized technician
representing Gnatus, will it be ready to start work operations.
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INSTALLATION OF EQUIPMENT
1 - Procedures for hydraulic installation:
a) Connect the hose (it has the water filter) into water input (19) and tighten the nut
(Ultrasonic Duo) so that the filter is close to the Ultrasonic Duo
b) A bronze sintered filter of 30 micros is incorporated in the water hose (only for the
models: Jet Sonic and Ultrassonic)
c) Connect inside the connection box , the other extremity of the water hose, to the
pressurized water hose that is in the reservoir , using the TEE to the connection.
d) Connect the cable for the power input (20).
ATTENTION: Do not invert the voltage when the appliance is turned on.
20
19
21
19
19
INSTALLATION OF EQUIPMENT
PHOTOPOLYMERIZATOR
11
22
10
08
23
• Remove the protection cover (22) from the light conductor (10).
• Insert the light protection shield (11) in the light conductor (10) and place the assembled
equipment in the charging base (23).
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OPERATION OF EQUIPMENT
ULTRASONIC DUO
On
Off
01
01 - On/Off Switch;
C - Power (adjustment of ultrasonic power);
D - Water (adjustment of water flow);
06 - Actuate the pedal.
06
C D
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OPERATION OF EQUIPMENT
12
15
16
17
13
14
ATTENTION:
- To recharge the photopolymerizator’s battery, on/off switch (01) must be at
the on position.
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OPERATION OF EQUIPMENT
ATTENTION:
- Recharge the battery when one of the LED continuous, ramp and pulsed are
blinking;
- Keep the handpiece in the charging base (connected to the mains power)
when not using;
- When the LED of the charging base (09) is indicating red, the battery is being
charged;
- The approximate recharging time is 3 hours. After recharging the LED in the charging
base (09) it will change to green, indicating the complete recharging;
- The battery does not have a memory effect and can be recharged even if it is not
completely discharged.
• Continuous:
Maximum and continuous mode of light
intensity (same luminosity from start to
finish of the polymerization).
• Ramp:
Gradual mode of light intensity, it increases
gradually.
• Pulsed:
Pulsing mode consisting of cycles which oscillate at
a fixed frequency.
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23
OPERATION OF EQUIPMENT
Automatic disconnection: The equipment will be turned off automatically to save
energy. Thus, if the appliance is not on the charging base and the user doesnot use
it within 3 minutes, the appliance turns off automatically. In order to turn it on again,
press the on/off button (14).
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OPERATION OF EQUIPMENT
Periodontics
Insert Nº 1 “Removal of supragengival calculus”
Tip Nº1 is used for lingual, buccal and approximal
supragingival scaling. Recommended for the removal of gross
calculus.
(Comes with the product)
Recommended power setting: 10-50%.
Endodontia
Insert Nº ET-20 “Preparation of canal”
Tip ET-20 is used in the pulp chamber for removing pulp
stones, dentin and old fillings. Length: 17 mm.
Recommended power setting: 10-25%.
(optional item)
25
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OPERATION OF EQUIPMENT
Endodontia
Insert Nº S12-90 “Apical surgery”
Tip S12-90 is angled at 110° and is used in combination
with the instrument holders A-120 and A-90 With the aid of
the instrument holder, the S12-90 can be precisely positioned
at the angle needed for the treatment.
(optional item)
Recommended power setting: 10-50%.
Important recommendation
The form and weight of each insert are determining factors for obtaining a maximum
performance from the generator of scalers. The operator should pay all due attention to these
two features to ensure the maintenance of the best performances of the unit. However, we
recommend that the structure of the insert is not altered (filing it or twisting it), just as the
aging of an insert leads to its original features being altered, making it inefficacious.
Any insert which has been damaged by use or by accidental impact must be replaced.
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PRECAUTIONS, RESTRICTIONS AND WARNINGS
Transportation and storage
This equipment must be transported and stored observing the following directions:
- Avoid falls and impacts;
- Keep it dry, do not expose it to rain, water drops or wet floor;
- Keep it away from water and direct sunlight, and in it original wrapping;
- Don’t move it over irregular surfaces, protect it from rain and observe the maximum
stack quantity specified in the packaging;
- Transportation and storage temperature range: -12°C to 50°C;
- Transportation and storage relative humidity range: 0°C to 90°C;
- Atmospheric pressure range: 500hPa to 1060hPa (375 mmHg to 795 mmHg).
The Equipment maintains its condition of safety and efficacy, provided that it is
maintained (stored) as mentioned in this instruction of use. Thus, the equipment
will not lose or alter its physical and dimensional features.
ATTENTION: The equipment should only be used with power input cable supplied
by Gnatus. Otherwise, it may cause an increase in the emissions of reduction in the
immunity of the equipment.
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PRECAUTIONS, RESTRICTIONS AND WARNINGS
- The equipment must be grounded correctly.
- Before the first use and/or after long interruptions from work such as vacations, clean
and disinfect the equipment; eliminate air and water deposited in the internal hoses.
Ultrasound: The use of the Ultrasound is not advisable for patients and dental
surgeons using pacemakers.
Gnatus shall not be responsible for:
- Use of the equipment differing from that for which it is intended.
- Damages caused to the equipment, the professional and/or the patient by the incorrect
installation and erroneous procedures of maintenance, differing from those described in these
Instructions for use which come with the equipment or by the incorrect operation of it.
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PRECAUTIONS, RESTRICTIONS AND WARNINGS
Precautions and warnings during the “cleaning and disinfection”
of equipment
- Upon disinfecting the handpiece remove the light conductor, use neutral soap or alcohol
70% vol. Never use iodopovidone, glutaraldehydes, or chlorinated products, as over time, they
attack the surface of the body of the instrument. Never submerge the instrument in disinfecting
baths.
- Before cleaning the equipment, turn off the main switch.
- Avoid spilling water, even accidentally, or other liquids inside the equipment, which could
cause short circuits.
- Do not use microabrasive material or steel wool when cleaning, or employ organic solvents
or detergents which contain solvents such as ether, stain remover, gasoline etc.
Ultra-som:
- After use, remove the insert to avoid damage.
- The part should be packaged duly clean.
- Do not sterilize the transducer in contact with other types of material.
- The inserts should be cleaned beforehand eliminating all the resin residue.
- After removing the insert from the transducer, it should be disinfected with surgical spirit
and taken to be sterilized in autoclave.
- Before placing or removing the cover of the transducer, it is advisable first to remove the
insert from the transducer, in order to avoid any damage to the cover.
- Never expose the covers of the transducer to any type of oil, as this may modify the structure
of the material, jeopardizing its useful life.
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CORRECTIVE AND PREVENTIVE MAINTENANCE AND
PRESERVATION
Cleaning
Important: In order to execute cleaning or any type of maintenance, ensure that the
equipment is disconnected from the electrical network.
WARNING:
- In order to prevent risks and damages to equipment, make sure that the
liquid does not enter into the unit.
- The application of other solvent-based cleaning products or sodium
hypochloride isn’t recommended, because they may damage the equipment.
• WATER FILTER
Disarm the filter as the picture
below. Wash the sintered with brush
and dry with compressed air.
When mounting again, verify
the filter direction, water must
flow through the filter on the arrow
direction of the following picture.
30
CORRECTIVE AND PREVENTIVE MAINTENANCE AND
PRESERVATION
Disinfection
- Use clean and soft cloth dampened in alcohol 70% to disinfection of the equipment.
- Never use corrosive disinfectants or solvents.
Sterilization
Transducer cover, bicarbonate jet handpiece (without the hose), inserts and insert
tightening wrench are autoclavable at a maximum temperature of 134ºC.
Scaler: Remove the insert of the transducer, and then turn the cover (B) in a clockwise
direction, pull it forwards (A) and take it for sterilization in autoclave (packed).
Preventive Maintenance
The equipment should be calibrated routinely, as per the legislation in force in the country.
But never with a period exceeding 3 years.
In order to protect your equipment, seek Gnatus technical assistance for periodic revisions
of preventive maintenance.
WARNING: Never expose the transducer’s cover to any kind of oil, because it may
modify the material’s structure, affecting its useful life.
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31
CORRECTIVE AND PREVENTIVE MAINTENANCE AND
PRESERVATION
Corrective Maintenance
• REPLACEMENT OF FUSES
With the aid of a screwdriver, loosen the lid
(24) of the fuse holder, and then replace the
fuse 1 A (25).
24
25
If the equipment has any abnormality, check if the problem is related to any of the items
listed in the item Unforeseen Events (situation, cause and solution).
If it is not possible to solve the problem, turn off the equipment, and request Gnatus
technical assistance.
32
UNFORESEEN EVENTS – SOLUTION OF PROBLEMS
Upon coming across any problem in operation, follow the instructions below to check
and repair the problem, and/or get in touch with your representative.
- The Curing Light does not - Battery in the handpiece - Recharge the handpiece on
work. without charge. the base for 3 hours.
- Overheating protection - Wait a few minutes.
activated “error code: oU. - Get in touch with the Gna-
- LED damaged “error tus technical assistance.
code: Er.
- The equipment is not - Resin not appropriate for - Acquire the appropriate
polymerizing the resins. the wavelength range of the resin for the wavelength of
LED curing lights. the curing light, i.e., which
- Light conductor fastened contain photoinitiators with
incorrectly. canforoquinone.
- Residue of resin in the - Fasten the light conductor
light correctly.
conductor. - Clean the light conductor.
- Light conductor with pro- - Remove the protection
tection cover. cover from the light con-
ductor.
- Inadequate luminous po- - Light conductor fastened - Fasten the light conductor
wer. incorrectly. correctly.
- Problems with the light - Replace the light conduc-
conductor. tor.
- Reduced capacity of the - Get in touch with the Gna-
battery. tus technical assistance.
33
33
WARRANTY OF EQUIPMENT
This equipment is covered by the warranty terms counting from the date of installation,
as specifi ed below; provided that the defect has occurred in normal conditions of use and
that the equipment has not remained stored for more than 06 months counting from the
issue date of the sales document until the date of the actual installation.
- WARRANTY TERMS: Verify the guarantee certificate;
- LOSS OF THE WARRANTY:
A) Attempt to repair using an inadequate tool or by unauthorized technicians;
B) Installation of the equipment by an unauthorized technician;
C) Damage arising from inappropriate storage or signs of infringement;
D) Incorrect use of the equipment;
E) Use of a cleaning product not indicated by the factory;
F) Falls or blows which the equipment may undergo or lack of observation of an compliance
with the guidelines of the Owner’s Manual, which was delivered with the present document,
together with the equipment. Repair or replacement of parts during the warranty period
shall not extend the validity term of their warranty.
- This warranty doe snot exempt the customer from paying the service charge for the visit
and the travel expenses of the technician, except when the customer sends the equipment
to execute the maintenance inside the establishment of the technical assistance.
“Consumer Defense Code - art. 50, unique paragraph”.
- The Warranty Certifi cate comes with the product and must be filled in upon the date
of installation by the Gnatus Authorized Technician.
- Queries and information: GNATUS Help Desk (+55) 16 2102-5000.
- Check the warranty term attached to this manual.
FINAL CONSIDERATIONS
The most important aspect related to equipment care is that concerning spare parts.
To guarantee the life span of your equipment, use only original Gnatus spare parts. They
are sure to follow the technical specifications and standards required by Gnatus.
We must also point out to you our chain of authorized dealers. Only dealers that make
part of this chain will be able to keep your equipment constantly new for they count on
technical assistants who have been trained and on spedific tools for the correct maintenance
of your equipment.
Doubts and information: GNATUS Call center (55-16) 2102-5000.
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