SAEVO Sonic Duo User manual

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[THIS PAGE IS INTENTIONALLY LEFT BLANK]

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MANUAL PRESENTATION
Trade Name: Equipment for Prophylaxis by Ultrasound / Bicarbonate Jet
Models: Sonic Duo / Sonic Duo Fit / Sonic / Sonic Fit
Brand: Saevo
Technical Responsible: Daniel R. de Camargo
CREA-SP: 5062199650
ANVISA Registration Nº: 10069210086
Document originally written in Portuguese.
Alliage S/A Industrias Médico Odontológico
Rodovia Abrão Assed, Km 53 - CEP 14097-500
Ribeirão Preto - SP - Brazil
Phone: [phone]
77000000863 - Rev.: 08 - Abril/20

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TRADEMARKS
All terms mentioned in this manual that are known trademarks, registered trademarks or service
marks have been appropriately labeled as such. Other products, services or terms that are mentioned
in this manual may be trademarks, registered trademarks or service marks of their respective owners.
Alliage S / A makes no claims regarding these trademarks. The use of a term in this manual should
not be considered to inuence the validity of any trademark, registered trademark or service mark.
Copyright © 2019 Alliage S/A. All rights reserved.
The performance characteristics provided in this manual are for reference only and should not be
considered as guaranteed specications.

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SUMMARY
01 GENERAL INFORMATION 08
1.1. DEAR CUSTOMER 08
1.2. INDICATIONS FOR USE 08
1.3. CONTRAINDICATIONS 08
1.4. SYMBOLOGY 08
02 WARNINGS, CAUTIONS AND RECOMMENDATIONS 12
03 SYSTEM OVERVIEW 17
3.1. SYSTEM DESCRIPTION 17
3.2. APPLICATION SPECIFICATION 17
3.2.1. Principles of operation 17
3.2.2. Signicant physical characteristics 17
3.2.3. User prole 18
3.3. MAIN PRODUCT COMPONENTS 19
3.3.1. Sonic Duo 19
3.3.2. Sonic Duo Fit 20
3.3.3. Sonic 21
3.3.4. Sonic Fit 22
3.4. SETS AND ACCESSORIES 23
3.5. APPLIED PARTS 26
3.6. USER INTERFACE 27
3.6.1. Sonic Duo / Sonic Duo Fit 27
3.6.2. Sonic 28
3.6.3. Sonic Fit 29
3.7. LABEL POSITIONING 29
3.8. SYSTEM REQUIREMENTS 30
3.8.1. Compressor requirements 30
3.8.2. System layout 30
3.9. EQUIPMENT INSTALLATION 31
04 OPERATION 33
4.1. INITIAL PREPARATION 33
4.1.1. Sonic Duo / Sonic Duo Fit 33
4.1.2. Sonic 34
4.1.3. Sonic Fit 34
4.2. USING THE ULTRASOUND 35
4.2.1. Operation 35
4.2.2. Techniques and applications 36
4.3. USE OF THE BICARBONATE JET 36
4.3.1. Operation 36
4.3.2. Supply of the bicarbonate jet 38
4.3.3. Filling the peristaltic pump reservoir 38
05 CLEANING, DISINFECTION AND STERILIZATION 40
5.1. EQUIPMENT 40
5.1.1. Ultrasound 40
5.1.2. Bicarbonate Jet 40
5.2. BICARBONATE CONTAINER 41

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SUMMARY
06 TROUBLESHOOTING 43
6.1. SOLUTION OF PROBLEMS 43
07 INSPECTION AND MAINTENANCE 45
7.1. PERIODIC INSPECTION 45
7.2. PREVENTIVE MAINTENANCE 45
7.3. CORRECTIVE MAINTENANCE 46
7.3.1. Equipment 47
7.3.2. Bicarbonate Jet Pen 47
7.4. ALLIAGE AUTHORIZED SERVICE NETWORK 47
08 WARRANTY 49
8.1. WARRANTY TERMS 49
8.2. WARRANTY PERIOD 49
09 STANDARDS AND REGULATIONS 51
10 TECHNICAL SPECIFICATIONS 53
10.1. EQUIPMENT CLASSIFICATION 53
10.2. APPLIANCE INFORMATION 53
10.3. SPECIFIC INFORMATION 54
10.4. ULTRASOUND SPECIFICATIONS 55
10.5. ENVIRONMENTAL CONDITIONS 55
10.6. EQUIPMENT DIMENSIONS 56
10.6.1. Sonic Duo 56
10.6.2. Sonic Duo Fit 57
10.6.3. Sonic 58
10.6.4. Sonic Fit 59
11. ELECTROMAGNETIC COMPATIBILITY 61
11.1. GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC EMISSIONS 61
11.2. ORIENTATION AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY 62

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1
GENERAL INFORMATION
Alliage S/A Industrias Médico Odontológico
Telephone: [phone]
Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brazil

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1. GENERAL INFORMATION
1.1.DEAR CUSTOMER
Congratulations on your excellent choice. When you buy ALLIAGE quality equipment, you can be
sure of purchasing products with technology compatible with the best in the world in their class.
This manual provides you with a general presentation of your equipment, describing important details
that can guide you in its correct use, as well as in solving small problems that may eventually occur.
This manual must be read in full and kept for future reference.
1.2.INDICATIONS FOR USE
The Saevo Ultrasound / Bicarbonate Jet Prophylaxis Equipment is intended to assist in dental
treatments such as removing plaque and residual stains; tartar removal; periodontal treatment;
endodontic treatment; micro retro surgery; cavity preparations for restorations; amalgam
condensation, inlays and on lays and gutta percha; removal of pins and crowns, among other
procedures related to dental treatments.
1.3.CONTRAINDICATIONS
This equipment is contraindicated for use in patients who have serious respiratory, renal or
hemodialysis changes, these cases must have medical monitoring. We recommend the use of a mask
and glasses to apply the bicarbonate jet.
1.4.SYMBOLOGY
The following symbols are used both throughout this manual and on the product. Make sure you
fully understand each symbol and follow the instructions that come with it.
Fragile, handle with care Maximum stacking
Protect from rain Temperature limit
This side Up Protect from direct sun
Model number Recyclable

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Catalog number
Sterilizable in a steam sterilizer
(autoclave) at specified
temperature
Type B applied parts
Indicates that the product must be
taken to a special waste collection
site at the end of its useful life.
Applies to both the device and
accessories
Attention Electrostatic sensitive devices
(ESD)
Protective ground wire General warning
Alternating current Serial number
Turn O
(Power: Disconnects from the main
switch) Mandatory action
Turn On
(Power: Connects from the main
switch) Follow the instructions for use

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Manufacturer Manufacturing date
Model Ultrasound
Bicarbonate jet Power – Ultrasonic power
adjustment knob
Air – Air ow regulation button Water – Water flow regulation
button
SScaling function
(micro retro surgery) PPeriodontal function (periodontics)
EEndo function
(endodontics)

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2
WARNINGS, CAUTIONS AND RECOMMENDATIONS
Alliage S/A Industrias Médico Odontológico
Telephone: [phone]
Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brazil

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General warnings
During transportation
During the installation of the equipment
2.WARNINGS, CAUTIONS AND RECOMMENDATIONS
Read and understand all instructions contained in these instructions for use
before installing or operating this equipment.
Use only the equipment in perfect condition and protect yourself, patients
and others against possible dangers.
The Saevo Ultrasound / Bicarbonate Jet Prophylaxis Equipment has 4 dierent
interactions with the user, they are:
- Identication label: Located on the side of the equipment;
- Safety symbols: Located at risk locations and on their identication tag;
- Central panel;
- Pedal.
The equipment must be transported and stored, observing the following:
• Handle with care to avoid falls, excessive vibrations and impacts;
• The arrows on the packaging must be pointing upwards;
• To handle the package as a single unit, consider the center of gravity indicator;
• Do not stack above the quantity indicated on the packaging;
• Do not walk or stand above the package
• Protect against sunlight, moisture, water and dust;
• Observe the temperature, pressure and relative humidity limits.
The installation procedure must be carried out by an authorized technician.
Instructions for installing the equipment are found in this manual.
To avoid the risk of electric shock, this equipment must only be connected to
a mains supply with a protective ground.
Before turning on the equipment, make sure that it is connected to the correct
voltage.

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• The equipment must be installed only by authorized technical assistants.
• The service manual's recommendations regarding the mandatory existence of protective earth
must be followed.
• The recommendations in the service manual regarding the mandatory existence of a protective
circuit breaker must be followed.
• Install the equipment in a place where it will not be in contact with moisture, water, plants and
animals.
• Install the equipment in a location where it will not be damaged by pressure, temperature, humidity,
direct sunlight, dust, salts or corrosive products.
• The equipment must be correctly attached according to the service manual and must not be
subjected to an inclination greater than 5 °. Risk of tipping.
• This equipment is not designed for use in the presence of vapors from ammable anesthetic
mixtures or nitrous oxide.
• Place any other external devices at least 1.5 meters away from the equipment, so that the patient
cannot touch any other external devices while they are being attended to.
• The recommendations in this manual for EMC should be followed. Communications equipment and
RF generating sources can aect the operation of the equipment.
• Equipment may cause radio interference or interrupt the operation of nearby equipment, making
it necessary to take mitigating measures, such as reorientation, relocation of equipment or shielding
the location.
To help ensure proper hygiene and protect against infectious diseases, before using for the rst
time, the equipment must be cleaned and disinfected according to the instructions contained in
this manual.
• Under no circumstances can the patient operate the equipment.
• The patient must not touch other parts than those specic to be treated.
• The equipment must be operated only by qualied health professionals.
• To operate the equipment, operating personnel must:
- Read and understand the user manual
- Be familiar with the basic structure and functions of this equipment.
- Be familiar with the emergency situation protocols for this equipment.
- Be able to recognize irregularities in the operation of the equipment and implement the
appropriate measures, when necessary.
• The equipment has been designed according to the electromagnetic compatibility standards,
but in very extreme conditions, it can cause interference with other equipment. Do not use
this equipment in conjunction with other devices that are extremely sensitive to interference
or with devices that create high electromagnetic disturbances.
• Do not position the patient on the equipment while starting it, as the patient may be injured
if the equipment does not work properly. In the event of an error that requires turning the
equipment o and on, remove the patient before turning it on again.
• In case of risk to the patient, press the emergency button immediately located on the side
of the equipment.
• If this product is exposed to water, moisture or foreign substances, turn it o immediately
and contact an Alliage Authorized Service Center.
• In case of damage or defect, do not use the equipment and contact an Authorized Alliage
Service Center.
• Do not use the equipment if any of its compartments or parts are damaged, loose or have
been removed. Contact an Alliage Authorized Service Center and request repair or replacement
Before using the equipment
While using the equipment

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of any damaged, loose or removed enclosures or parts of the equipment before using the
equipment again.
• Do not touch the equipment or use it if it is being repaired or if the equipment's cabinets
have been removed.
• Do not open or remove any of the equipment's cabinets. No internal parts can be repaired
by the user.
• In case of falling or impact of moving parts causing it to break, be careful when handling
them, there may be sharp parts.
• The operator cannot come into contact with the patient when in contact with accessible
connectors.
• The operator cannot use tools to open the equipment.
• When using the product, the dental tip can reach the normal use temperature of 114.2 ° C.
That if you are in contact for more than 1 min there may be a risk of slight supercial burns
or irritation.
• If there are obstructions or blockages in the cooling system, the tip can reach a maximum
rate of temperature increase of 63% (179.7 ° C). That if you are in contact for more than 1 min
there may be a risk of slight supercial burns or irritation.
• Turn o the equipment if it is not in use for a long time
• All parts that have been in contact with the patient must be cleaned and disinfected / sterilized
with each new patient to prevent the transmission of infectious agents that can cause serious illness.
• Perform cleaning and disinfection / sterilization according to instructions contained in this manual.
• Do not unplug the cable or other connections unnecessarily.
• Do not modify any part of the equipment.
If the equipment shows any abnormality, check if the problem is listed in any item listed in the “Problem
diagnosis” topic of this user manual.
If it is not possible to solve the problem, turn o the equipment, contact an Alliage Authorized Technical
Assistance.
• For each new patient, perform cleaning, disinfection / sterilization procedures and according to
the instructions contained in this manual.
Cross contamination prevention
After using / operating the equipment
Precautions in case of alteration of the equipment operation
Adequate cleaning and disinfection / sterilization measures should be taken
to avoid cross-contamination between patients, users and others.
The manufacturer is NOT responsible:
• If the equipment is used for purposes other than those for which it was
designed.
• For damage caused to the equipment, the operator and / or the patient, as a
result of incorrect installation and maintenance procedures that do not comply
with the operating instructions that accompany the equipment.

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This equipment must not be disposed of as household waste
The equipment packaging consists of cardboard and polyethylene that are
100% recyclable materials.
Alliage S / A aims to achieve an environmental policy to promote the supply of environmentally
conscious medical and dental products that continually minimize environmental impact and are
more friendly to the environment and human health.
To maintain a minimal impact on the environment, observe the recommendations below:
• After installation, send recyclable materials for recycling process.
• During the life cycle of the equipment, turn it o when it is not in use.
• To prevent environmental contamination, the disposal of waste and consumables must follow the
normal procedure for biomedical waste.
Biomedical waste includes non-acute materials that may cause disease or suspicion of harboring
pathogenic organisms that must be stored in a yellow bag properly labeled with a biohazard symbol,
stored in a puncture-resistant, watertight container until collection and incineration.
To avoid environmental contamination or improper use of the equipment, when it is unusable, it must
be disposed of (in accordance with current legislation) in an appropriate place, as the materials
inside can contaminate the environment.
For the European Economic Area (EEA), this product is subject to Directive 2012/19 / EU, as well
as the corresponding national laws. This directive requires that the product must be taken to a
special waste collection site at the end of its useful life. Applies to both device and accessories
Contact your dealer if nal product placement is required.
DIMENSIONS:
380 x 380 x 270mm /MASS: Approximately: 10 Kg
Precautions for reducing environmental impact
Precautions in case of unusable equipment

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3
SYSTEM OVERVIEW
Alliage S/A Industrias Médico Odontológico
Telephone: [phone]
Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brazil

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3.1.SYSTEM DESCRIPTION
3.SYSTEM OVERVIEW
Equipment for prophylaxis by ultrasound and Bicarbonate Jet, modern and bold design, assembled
together composed of body and cover made of ABS (Acrylonitrile, butadiene, styrene) and digital
control panel in polycarbonate. Available in cart and bench models.
Synchronized electropneumatic system, with valves that provide cuts and aspirations of water
instantly, thus avoiding water contact with bicarbonate at the tip of the handpiece.
It has Piezoelectric ultrasound activated through ceramic tablets in which it allows use in operations
without the use of water.
Removable bicarbonate jet pen, with concentric diuser that mixes air, water and bicarbonate a
short distance from the tip.
Transducer cover made of rigid and self-cleaning thermoplastic resin.
Function selector key with 3 programmable options, P (periodontal), E (endo) and S (scaling).
Fine adjustment potentiometer for precise regulation of ultrasonic power, suitable for each type
of procedure.
Internal depressurization through automatic scanning of the bicarbonate, from the valves to the
handpiece.
Bicarbonate container with easy access, transparent and removable that allows its removal without
the need to turn all the equipment to remove the leftover bicarbonate powder.
Bicarbonate jet interruption system with an anti-agglutination module that prevents clogging in
the valves.
It has a contamination-free system for feeding the ultrasound pens and the bicarbonate jet, through
the peristaltic pump with antiseptic liquid, water, serum or similar. The peristaltic system has the
function of pulsating the liquid from the reservoir to the tips (ultrasound and bicarbonate jet).
3.2.APPLICATION SPECIFICATION
The Dental Prophylaxis by Sodium Bicarbonate / Ultrasound project is intended for prophylaxis
with ultrasound and bicarbonate jet, which was developed to be used in various dental practices
such as: periodontics, endodontics, prosthesis, surgery and others.
Ultrasound is derived from physical vibrations of matter particles, similar to sound waves, with a
frequency higher than the level of human perception, which produces a frequency of up to 30,000
vibrations per second.
The Bicarbonate Jet (Prophylaxis) comes from the release under pressure of sodium bicarbonate
particles that, together with the water, mix in the tip of the tip forming a jet in the form of a
concentrated spray.
3.2.1.Principles of operation
It has Piezoelectric ultrasound activated through ceramic inserts at a frequency of 30,000 Hz. The
Piezoelectric system of the transducer allows use in operations without the use of water.
3.2.2.Signicant physical characteristics

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The user to operate and handle the Ultrasound and Bicarbonate Jet must be aged between 18 and
70 years old, both sexes, with the ability to read and understand images, symbols, icons, western
Arabic characters (Arial font), alpha numeric characters, to know distinguish intraoral part of the
human body, not being able to present a degree of visual imperfection for reading or seeing and
an average degree of impairment of recent memory, not being clearly able to perform the activities
and functions of the product in a correct manner to the profession.
The user needs to be a qualied health professional and trained to perform the activities, functions
frequently used in the application of Dental Prophylaxis by Sodium Bicarbonate / Ultrasound and
their primary operations functions.
3.2.3.User prole

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3.3.MAIN PRODUCT COMPONENTS
3.3.1.Sonic Duo
01. On/O switch
02. Ultrasound selection button or bicarbonate jet
03. Ultrasound function selection key (PES)
04. Ultrasonic variation regulator
05. Water ow regulator
06. Air ow regulator
07. Bicarbonate jet pen
08. Ultrasound pen
09. Tip support
10. Foot pedal
11. Power input cable
12. Reservoir for peristaltic
13. Bicarbonate container
11
10
07
13
12
01
08
09
02 03
04
05
06

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3.3.2.Sonic Duo Fit
01. On/O switch
02. Ultrasound selection button or bicarbonate jet
03. Ultrasound function selection key (PES)
04. Ultrasonic variation regulator
05. Water ow regulator
06. Air ow regulator
07. Bicarbonate jet pen
08. Ultrasound pen
09. Tip support
10. Foot pedal
11. Power input cable
12. Bicarbonate container
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10
07
12
01
08
09
02 03
04
05
06