SAEVO Sonic DuoFit User manual

2
PRESENTATION OF MANUAL
INSTRUCTIONS FOR USE
CAUTION
Technical Name: Equipment for Dental Prophylaxis by Sodium Bicarbonate/Ultra-sound.
Trade Name: Equipment for Dental Prophylaxis by Sodium Bicarbonate/Ultra-sound.
Model: Sonic Duo / Sonic Duo Fit / Sonic
Brand: Saevo
Manufacturer / Distribuitor:
Alliage S/A Indústrias Médico Odontológica
C.N.P.J. 55.979.736/0001-45 - Insc. Est. 582.002.897.114
Rod. Abrão Assed, Km 53+450m - Cx. Postal 782 CEP 14097-500
Ribeirão Preto - S.P. - Brasil
Telefone [phone]
Technical Duties: Ricardo J. Ravaneli
CREA-SP: 5060714523
Registration ANVISA #: 10069210086
For improved safety:
Read and understand all the instructions contained in the Instructions for Use before installation
or operation of this equipment.
Note: The Instructions for Use must be read by all persons that operate this equipment.

3
INDEX
02 PRESENTATION OF MANUAL
04 IDENTIFICATION OF EQUIPMENT
06 MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION
12 TECHNICAL SPECIFICATIONS
12 General features
13 Electromagnetic emission
17 Dimensions
21 Packing symbols
21 Product symbols
23 INSTALLATION OF EQUIPMENT
23 EQUIPMENT OPERATION
30 PRECAUTIONS, RESTRICTIONS AND WARNINGS
30 Transportation, storage and operation
30 Sensitivity to predictable environmental conditions in ordinary situations of use
31 Precaution and warnings “during the installation” of the equipment
31 Recommendations for preserving the equipment
31 Precautions and warnings “during the use” of equipment
32 Precautions and warnings “after” the use of equipment
32 Precautions and warnings during the “cleaning and disinfection” of equipment
32 Precautions in case of alteration in the functioning of equipment
32 Precautions to be adopted against foreseeable or uncommon risks, related to the deactivation
and abandoning of equipment
33 CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION
33 Additional procedures for reuse
33 Cleaning
33 Disinfection
34 Sterilization
34 Preventive Maintenance
34 Corrective Maintenance
36 UNFORESEEN EVENTS – SOLUTION OF PROBLEMS
37 EQUIPMENT’S WARRANTY
37 FINAL CONSIDERATIONS

4
IDENTIFICATION OF EQUIPMENT
Dear Customer
Congratulations. You have made a good choice when you decided to buy a SAEVO 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.
Indication of Equipment
This equipment is for dental use use only. It must be operated and utilized by specialized professional
(certied 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.
IDENTIFICATION OF PRODUCT
Technical Name: Equipment for Dental Prophylaxis by Sodium Bicarbonate/Ultra-sound.
Trade Name: Equipment for Saevo Bicarbonate Jet/Ultra-sound Prophylaxis.
Model: Sonic Duo / Sonic Duo Fit / Sonic
Brand: Saevo
Purpose of the equipment
The Sonic Duo is an item of equipment for prophylaxis with Ultra-sound and bicarbonate jet, which
was developed to be used in several dental practices such as: periodontics, endodontics, prosthesis,
surgery, etc.

5
Description of Equipment
Equipment for prophylaxis with Ultra-sound and Bicarbonate Jet, modern and bold design, assembled
in a set composed of 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.
Electric-pneumatic synchronized system, with valves that provide cuts and aspirations of the water
instantly, avoiding like this the contact of the water with the bicarbonate in the point of the hand piece.
It has a Piezoelectric Ultra-sound 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.
Removable bicarbonate jet pen, with concentric diuser which mixes the air, water and bicarbonate
at a small distance from the handpiece.
Cover of the transducer made out of rigid and autoclavable thermoplastic resin.
Selector key of functions with 3 programmable options, P (perio), E (endo) and S (scaling) according
to the model purchased.
Potentiometer with a ne adjustment for precise adjustment of the ultrasonic power, suited to
each type of procedure.
Internal depressurization through automatic sweep of the bicarbonate, of the valves up to the
handpiece.
Container for bicarbonate easy to access, transparent and removable, which allows itsremoval
without needing to turn all the equipment upside down in order to remove the remains of bicarbonate
powder.
Bicarbonate jet interruption system with a module of anti-agglutination which avoids the obstruction
of the valves.
It has a system exempt of contamination for supplying the handpieces of the Ultra-sound and
bicarbonate jet, through the peristaltic pump with antiseptic liquid, water, serum or similar. The
peristaltic system has the function of pulsing the liquid of the reservoir to the handpieces (Ultra-
sound and bicarbonate jet).
Air lter with automatic drainage and foot control for activation.
WORKING APPLICATION
• Distartarization
• Periodonty
• Endodonty
• Scaling (Micro-recto surgery)
• Amalgam condensation
• Inlays - onlays condensation
• Gutta Percha Condensation
• Pines and crown removal
Physical principle used by the equipment
The Ultra-sound 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.
The Bicarbonate Jet (Prophylaxis) comes from the release under pressure of particles of sodium
bicarbonate, together with the water, mixing together in the nozzle of the handpiece forming jet
in the form of a concentrated spray.
*Optional
IDENTIFICATION OF EQUIPMENT

6
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION
01 - On/o key
02 - Election key of the Ultra-sound and bicarbonate jet
03 - Alteration key of functions of Ultra-sound (PES)
04 - Regulator of sonic variation
05 - Water ux regulator
06 - Air ux regulator
07 - Jet of bicarbonate hand pieces
08 - Ultrasound hand piece
09 - Support of the points
10 - Actuation pedal
11 - Electrical cable
12 - Peristaltic pump reservoir
13 - Recipient of bicarbonate
Sonic Duo (PES)
11
10
07
13
12
01
08
09
02 03
04
05
06

7
01 - Switch with 3 positions:
• Turns on the Bicarbonate Jet
• Turns o the equipment
• Turns on the Ultra-sound
02 - Regulator of sonic variation
03 - Water ux regulator
04 - Air ux regulator
05 - Jet of bicarbonate hand pieces
06 - Ultrasound hand piece
07 - Support of the points
08 - Actuation pedal
09 - Electrical cable
10 - Peristaltic pump reservoir
11 - Recipient of bicarbonate
Sonic Duo
09
08
05
11
10
01
06
07
02
03
04
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION

8
01 - On/o key
02 - Election key of the Ultra-sound and bicarbonate jet
03 - Alteration key of functions of Ultra-sound (PES)
04 - Regulator of sonic variation
05 - Water ux regulator
06 - Air ux regulator
07 - Jet of bicarbonate hand pieces
08 - Ultrasound hand piece
09 - Support of the points
10 - Actuation pedal
11 - Electrical cable
12 - Recipient of bicarbonate
Sonic Duo Fit
11
10
07
12
01
08
09
02 03
04
05
06
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION

9
01 - On/o key
02 - Alteration key of functions of Ultra-sound (PES)
03 - Regulator of sonic variation
04 - Water ux regulator
05 - Ultrasound hand piece
06 - Support of the points
07 - Actuation pedal
08 - Electrical cable
09 - Peristaltic pump reservoir
Sonic
08
07
09
01
05
06 02
03
04
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION

10
Accessories which can come with the product, depending upon the version
chosen:
01
04
02 03
07
10 11 12
05 06
08 09
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION

11
The equipment hould only be used with the power input cable supplied by Saevo.
The use of any part, accessory or material not specied or provided in these instructions is of
entire responsibility of the user.
01 - Perio supra (01 unit)
02 - Perio sub (02 units)
03 - Fixation of tips key
04 - Transductor cover (02 units)
05 - Silicon hose
06 - Plunger
07 - Air tee to connection
08 - Actuation pedal
09 - Air hose
10 - Electrical cable
11 - Pedestal Sonic Duo (available for cart version)
12 - Bicarbonate packages
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION

12
TECHNICAL SPECIFICATIONS
Electric shock protection type
Class two equipment - Applied Part Type B
Protection against harmful water penetration or particulate material
IPX 0
Frequency of Ultra-sound
30.000Hz
Mode of Operation
Not continuous ("ON") 10 minutes. ("OFF") 10 minutes.
Capacity of Liquid (Peristaltic Pump reservoir)
1 liter
Transducer system
Piezoelectric ceramic
Power Supply Voltage
127V~ / 220V~ (Bivolt)
Frequency
50/60 Hz
Power
60VA
Compressed air inlet pressure
Maximum = 80 PSI
Minimum = 70 PSI
Net Weight
Sonic Duo: 4,00kg
Sonic Duo Cart: 9,00kg
Sonic Duo Fit: 3,70kg
Sonic Duo Fit Cart: 9,00kg
Sonic: 3,40kg
Sonic Cart: 8,00kg
Gross Weight
Sonic Duo: 5,00kg
Sonic Duo Cart: 13,00kg
Sonic Duo Fit: 4,50kg
Sonic Duo Fit Cart: 9,8kg
Sonic: 4,40kg
Sonic Cart: 12,00kg
General features
The materials used to produce the equipment are Biocompatible.

13
TECHNICAL SPECIFICATIONS
Electromagnetic emissions
Electromagnetic Emissions
The Sonic Duo is made to be used in the electromagnetic environments specied below. The client
or the user of the Sonic Duo must be sure that it is used in such environment.
Emission test Compliance Eletromagnetic environment - Guide
RF emissions
ABNT NBR IEC CISPR 11
Group 1 This Sonic Duo uses RF energy only for
internal functions.
However, its emissions are too low and it's
unlikely to cause any interference in the
equipments next to it.
RF emissions
ABNT NBR IEC CISPR 11
Class B
Emissions of harmonics
IEC 61000-3-2
Class A This Sonic Duo is proper to be used in
all establishments; including domestic
settings and those directly connect to a
public low voltage distribution which feeds
domestic buildings.
Fluctuation of Voltage /
Emissions of icker
IEC 61000-3-3
As per

14
TECHNICAL SPECIFICATIONS
Guidelines and manufacturer's declaration - electromagnetic immunity
The Sonic Duo is made to be used in the electromagnetic environments specied below. The
client or the user of the Sonic Duo must be sure that it is used in such environment.
Immunity
test
ABNT Test level
NBR IEC 60601
Level of
compliance
Electromagnetic
environment Directives
Electrostatic
discharge (ESD)
IEC 6100-4-2
± 6 kV Contact
± 8 kV Air
± 6 kV Contact
± 8 kV Air
Floors should be wooden,
concrete or ceramic. If
the floor is covered with
synthetic material, the
relative humidity should be
at least 30%.
Quick electric
transitory phases
/ train of pulses
(”Burst”)
IEC 61000-4-4
± 2 kV in power
supply lines
± 1 kV in input /
output lines
± 2 kV in power
supply lines
± 1 kV in input /
output lines
It is advisable that the
quality of the power supply
should be that of hospital
or typical commercial
environment.
Surges
IEC 61000-4-5
± 1 kV lines (s) to
lines (s)
± 2kV lines (s) to
ground
± 1 kV lines (s) to
lines (s)
± 2kV lines (s) to
ground
It is advisable that the
quality of the power supply
should be that of hospital
or typical commercial
environment.
Reduction,
i n t e r r u p t i o n
and variance of
voltage in power
supply input lines
IEC 61000-4-11
< 5% Ut
(>95% drop in Ut)
for 0,5 cycle
40% Ut
(60% drop in Ut)
for 5 cycles
70% Ut
(30% drop in Ut )
for 25 cycles
< 5%Ut
(>95% drop in Ut )
for 5s
< 5% Ut
(>95% drop in Ut )
for 0,5 cycles
40% Ut
(60% drop in Ut)
for 5 cycles
70% Ut
(30% drop in Ut )
for 25 cycles
< 5% Ut
(>95% drop in Ut )
for 5s
The recommended power
supply quality is the same
as used for commercial or
hospital environment. If
is required a continuous
use during energy supply
outages, it is recommended
that the Sonic Duo be feed
by an uninterruptible power
supply or a battery.
Magnetic eld in
f re q u e n c y o f
power supply
(50/60Hz)
IEC 61000-4-8
3 A/m 3 A/m If an image distortion occurs,
may be necessary place
the equioment far from
the supply frequency or to
installa magnetic armour.
The frequency magnetic
eld shall be measured at
the installment place to
assure that it is low enough.
NOTE Ut is the a.c. power supply voltage before the application of the test level

15
TECHNICAL SPECIFICATIONS
Guidelines and manufacturer's declaration - electromagnetic immunity
The Sonic Duo is made to be used in the electromagnetic environments specied below. The client
or the user of the Sonic Duo must be sure that it is used in such environment.
Immunity
test
ABNT test level
NBR IEC 60601
Level of
compliance
Electromagnetic Environment
Directives
RF conducted
IEC 61000-4-6
RF radiated
IEC 61000-4-3
3 vrms
150 kHz up to 80 MHz
3 V/m
80MHz up to 2,5 GHz
3 Vrms
3 V/m
It is advisable that portable and mobile RF
communication equipment is not used
near any part of the Sonic Duo, including
cables, with a separation distance less
than the one recommended, calculated
from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:
d = 1,2√P
d = 1,2√P 80 MHz thru 800MHz
d = 2,3√P 800 MHz thru 2,5MHz
Where P is the nominal maximum power of
output of the transmitter in watts (W), as
per the manufacturer of the transmitter,
and d is the recommended separation
distance in meters (m).
It is advisable that the el intensity from
the RF, transmitter as determined by
means of electric inspection on-sitea,is
less than the level of compliance in each
frequancy rangeb.
There may be interference near the
equipment
marked with the following symbol:
NOTE 1 At 80MHz and 800MHz, the highest frequency range applies.
NOTE 2 These directives may not be applicable in every situation. The electromagnetic
transmission is aected by the absorption and reection of structures, objects and people.
a - The eld intensities set by the xed transmitters, such as radio base stations, telephones
(mobile phone, wireless) land mobile radio, amateur radio, AM and FM radio transmissions and TV
transmissions can not be predicted with accuracy. Due to the RF xed transmitters is recommended
to install an electromagnetic inspection at the local in order to evaluate the electromagnetic
environment. If at the place where the Sonic Duo is be using the eld intensity level exceeds
the conformity level for the RF above, is recommended to observe if the operations are normal.
Whether abnormal operations are observed, additional procedures shall be necessary such as
reorientation or replace the Sonic Duo.
b - Whether above the frequency range of 150kHz to 80 MHz is recommended a eld intensity
below than 3 V/m.

16
TECHNICAL SPECIFICATIONS
Recommended distances between portable and mobile RF communication equipments and the
Sonic Duo
The Sonic Duo is made to be used in an electromagnetic environment in which RF disturbances
are controlled. The client or the user of the Sonic Duo may help preventing electromagnetic
interference by keeping a minimal distance between mobile and portable RF communication
equipment (transmitters) and the Sonic Duo as recommended below, in accordance with the
maximal voltage output of the communication equipment.
Transmitter Maximum
Output (W)
Separation distance according to transmitter frequency (M)
150 kHz to 80 MHz
d= 1,2√p
80 kHz to 800 MHz
d= 1,2√p
800 kHz to 2,5 GHz
d= 2,3√p
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters with a maximum nominal output power not listed above, the recommended d
separation distance in meters (M) can be determined using an equation applicable to the frequency
of the transmitter, where Pis the transmitter maximum nominal output in watts (W) according
to the transmitter manufacturer.
NOTE 1 At 80MHz and 800MHz, is applied the separation distance for the higher frequency range.
NOTE 2 These guidelines may not apply to all situations. The absorption and reection from
structures, objects and people aect the electromagnetic propagation.

17
Dimensions (mm)
TECHNICAL SPECIFICATIONS
203
310
336
Sonic Duo

18
Dimensions (mm)
440
862
479
Sonic Duo (Cart)
TECHNICAL SPECIFICATIONS

19
Dimensions (mm)
Sonic Duo Fit
TECHNICAL SPECIFICATIONS

20
Dimensions (mm)
Sonic Duo Fit (Cart)
TECHNICAL SPECIFICATIONS