cvdentus DentSurg PRO User manual

Rev. 13
INSTRUCTION MANUAL

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This User’s Guide contains the information necessary for correctly handling the DentSurg
Pro ultrasound equipment.
Manufacturer
Clorovale Diamantes Ind. e Com. LTDA
Estrada José Augusto Teixeira, 500 –Torrão de Ouro II
São José dos Campos / SP - Brazil
CEP: 12229-840
Phone: [phone]
website: www.cvdentus.com.br
email: [email protected]
CNPJ: 65.478.018/0001-49
Person in charge
LUIS FRANCISCO BONETTI
CPF: 270.664.418-42
CREA: 5061621860
Registration of the Product with the Brazilian Health Department
Technical name: DentSurg Pro
Trade name: DentSurg Pro
ANVISA/MS Registration number: 80179329001

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Preface...................................................................................................................................4
Introduction.............................................................................................................................4
Application..............................................................................................................................5
Principles of Operation of DentSurg Pro.................................................................................6
Classification of the equipment...............................................................................................6
Contraindications for use........................................................................................................8
Notes before use.....................................................................................................................9
Note to the dental surgeon......................................................................................................9
Details of the ultrasonic motion of the insert..................................................................10
Description of the components..............................................................................................10
Installation guide...................................................................................................................16
Before the first use................................................................................................................18
Expected distances...............................................................................................................18
Period of contact...................................................................................................................19
Instructions for use and operation........................................................................................19
Control panel and main unit connectors...............................................................................20
Identification of the applied parts...........................................................................................26
Operation procedures...........................................................................................................29
Preventive maintenance and inspection................................................................................31
Extending equipment life.......................................................................................................32
Cleaning and sterilization......................................................................................................32
Essential performance..........................................................................................................34
Electromagnetic compatibility...............................................................................................34
Identifying defects.................................................................................................................39
Warranty...............................................................................................................................40
List of symbols......................................................................................................................42
Index

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The DentSurg Pro equipment was designed to achieve maximum performance of the
handpiece along with high precision mechanical elements, causing the insert to vibrate axially
to the handpiece.
The high frequency to which the insert is subjected enables the more resistant calculus to be
removed more easily.
DentSurg Pro can conveniently and quickly clean your teeth, and it is electrically safe.
The electromechanical efficiency of this piezoelectric system is much higher than that of
traditional magnetostrictor systems. Piezoelectric systems release reduced amounts of heat,
making it possible to work with lower volumes of water for cooling, ensuring excellent
cavitation, resulting in a more comfortable use for both the patient and the dentist.
The equipment enables control over the power and water flow operation modes. There are 3
operation modes: a constant frequency, suitable for Endodontic procedures; another suitable
for Periodontics and Cavity Preparation; and, finally, one with intermittent power, suitable for
bone cutting processes. This allows a very fine adjustment for each clinical procedure.
The DentSurg Pro configuration is especially appropriate for the use of clinical and surgical
CVDentus tips. The circuit operates in a self-tuning frequency mode, which always provides
the required power for each insert. Never apply too much pressure because the best
protection and best cutting and wear efficiency come from the vibration of the tips.
The DentSurg Pro equipment, along with the CVDentus tips, are intended for dental
treatments using ultrasound. It enables a wide range of dental interventions with ultrasound,
including procedures in Endodontics, Periodontics, Dentistry, Cavitary Preparation, besides
small bone cuts.
DentSurg Pro includes two handpieces that enable self-tuning in a range of 27 to 32KHz.
Along with the CVDentus ultrasonic tip technology, it has the following advantages:
•Eliminates the noise of the traditional high-speed motor, improving the dentist’s working
condition and inhibiting the patient's most common fear;
•It is a painless treatment, eliminating the need for anesthesia in most dental treatments,
and ensuring greater precision, protecting the original structure of the tooth;
•Because it enables dental treatment without pain, a larger portion of the population might
seek preventive treatments;
•It does not cut the soft tissue, that is, it enables subgingival treatment without anesthesia
and without bleeding;
•Better finish with a single tip. There is no need for frequently changing the tips;
•Enables access to hard-to-reach regions when compared to conventional high-rotation
tips, or any other techniques;
•Enables better visibility during treatment, guaranteeing a procedure with lower risks,
preserving healthy tissue;
Introduction
Preface

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•Much greater durability (if used correctly), because it is a single diamond stone
chemically bonded to the metal rod;
•Brand-new bone-cutting mode allows bone windows to be made without affecting
adjacent tissues, such as the sinus membrane, nerves, and blood vessels.
•Indication:
Procedures:
oEndodontics
oPeriodontics
oCavity Preparation
oSmall bone cuts
•Intended Population (Patients): Patients of all ages. Because it does not cut soft
tissue and does not require anesthesia in most procedures, it can be used in children,
special patients and patients who have some type of allergic reaction to anesthetics.
•Contraindications: It is suggested that patients that have pacemakers avoid treatment
with the DentSurg Pro equipment.
•Body part: Used in the oral cavity for dental treatment.
•Characteristics of the intended patient: The DentSurg Pro equipment must be
operated exclusively by a dental professional, familiar with the risks and benefits currently
known for the use of electromedical equipment in dental offices. No specific training is
required. Reading the manual is mandatory before use.
•Intended conditions for use: DentSurg Pro should be used in dental offices that follow
the ANVISA sanitary standards. The office must have adequate electrical installations of
the right size and equipped with a ground rod. The office must follow the requirements for
hygiene and sterilization as well as itsfurniture, utensils and other equipment. The lighting,
ventilation and temperature must meet the health requirements of a dental office.
The equipment is NOT intended for use in an oxygen-rich environment.
DentSurg Pro is a piezoelectric ultrasound equipment for use in dental treatments. Inside
the handpieces are piezoelectric pads that, with an electric stimulus, vibrate at an ultrasonic
frequency (between 27 and 32 kHz). This vibration is amplified by the handpiece and
transmitted to the insert, which vibrates with high intensity. Ultrasonic vibration is used for
various endodontic and periodontal cleaning and disinfection procedures. With the addition
of CVDentus tips made of CVD diamond, this vibration is used for cutting hard materials such
as dentin, enamel, bone material and dental restorative materials.
Application
Principle of operation of DentSurg Pro

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WARNING
The DentSurg Pro equipment may cause electromagnetic interference to other
equipment or electronic devices.
WARNING: This equipment is not suitable for use in the presence of anesthetic
mixtures that are flammable when in contact with air, oxygen or nitrous oxide.
The equipment must be connected to the power network from an individual
outlet with grounding plug (third prong).
WARNING
Do not dispose of the equipment along with household waste. Use the
appropriate disposal system, following the laws of your country.
If not disposed of properly, electrical equipment poses a serious threat to the
health of nature and humans.
At http://www.e-lixo.org/, collection and recycling points can be found all over
Brazil. If you prefer, please contact CVD Vale.
WARNING –ULTRASOUND ENERGY NOISE:
Prolonged exposure to the noise can cause physiological effects such as stress,
loss of concentration and hearing loss.
The use of earplugs is recommended.
The DentSurg Pro ultrasound equipment and its parts, including the APPLIED PARTS, are
classified as follows.
Technical Specifications:
•PROTECTION AGAINST ELECTRIC SHOCKS:
oElectromedical Equipment (CLASS I).
•MAIN UNIT:
oInput: 100 –240V ~ 50/60Hz 52VA –61VA;
oSource protected by fuses (not accessible to the user);
oPower cable length: 2 meters;
oMaximum ultrasound power: 20W; at60Hz (cortical mode)and 30Hz (medullary
mode);
oDimension: width = 200 mm, height = 210 mm, and depth = 250 mm;
Classification of the equipment

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oWeight: 2,5 kg;
oMicroprocessor circuit with PWM power controller;
oHardware version: 2.0 (Oct/2017) / Software version: 2.1 (Oct/2017).
oInitial search of the resonance frequency from 27 to 32 Khz and with auto-power
adjustment under normal operating conditions.
oAutomatic power limiter for power control in case of excessive pressure on the
active tip.
•ACTIVATION PEDAL:
oMicroswitch activation pedal with standard opening, that is, it closes contact
when it is activated;
oCable length: 2 meters;
oDimensions: 75 x 75 x 30 mm;
oWeight: 0.075 kg.
•SURGICAL HANDPIECE:
oPiezoelectric with 6 PZT ceramic pads;
oInsulation for 3000V;
oRated frequency: 32 Khz;
oApproximate length: 114 mm;
oMaximum diameter: 20 mm; approximate weight: 20 g.
oAutoclavable.
•CLINICAL HANDPIECE:
oPiezoelectric with 5 PZT ceramic pads;
oInsulation for 3000V;
oRated frequency: 27 Khz;
oApproximate length: 114 mm;
oMaximum diameter: 20 mm; approximate weight: 20 g.
oAutoclavable.
•PROTECTION AGAINST HARMFUL PENETRATION OF WATER OR PARTICLES:
oMain unit - degree of protection: IP21;
oActivation pedal - degree of protection: IP21;
•STERILIZING METHODS:
oMoist heat sterilization (autoclave), temperature of 134°.
oCheck procedure: Cleaning and Sterilization.
WARNING: Must not be performed in Oven.
•OPERATION MODE:
oNon-continuous operation: “On” 10min / “Off” 5min;

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•ENVIRONMENTAL CONDITIONS:
oTemperature - Operation: +10°C to +30ºC. Storage: +10°C to +40ºC;
oHumidity - Operation: 30% - 80% without condensation;
oStorage: 10% - 90% without condensation.
oAtmospheric Pressure –Storage: 860-1060 hPa.
Operation/ use: 860-1060 hPa
Transport: 860-1060 hPa
•EQUIPMENT WITH TYPE B APPLIED PARTS.
This equipment is NOT intended for use in an oxygen-rich environment.
Note that electronic devices and electromedical equipment may interfere with the normal
operation of pacemaker devices. It is suggested that patients with pacemakers avoid
treatment with the DentSurg Pro equipment.
For additional literature on the subject, please see:
- "Advances in Cardiac Pacemaker", The New York Academy of Sciences, Vol. 167,
Article 2, pp. 515-1075.
- "Electromagnetic Radiation Interference with Cardiac Pacemaker", U.S.
Department of Health, Education and Welfare.
- "The Individual with a Pacemaker in the Dental Environment" Journal of the
American Dental Association, Vol. 91, No. 6 pp. 1224-1229.
IMPORTANT
DentSurg Pro must be operated exclusively by dental professionals, familiar with the risks
and benefits currently known for the use of electromedical equipment in dental offices. No
specific training is required. Reading the User’s Guide is mandatory before use.
WARNING: Cardiac pacemaker patients must not be treated with DentSurg
Pro, or even approach the equipment when it is in operation.
Contraindications for use

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We advise the dental professional to instruct their patients or others with access to the
equipment regarding care during handling.
Do not attempt to repair or assemble defective or inoperative components or replace with
parts from other appliances. The original technical specifications and the safety of the
appliance can be guaranteed only with the use of original parts.
To ensure the electrical safety of the unit during its lifetime, we recommend that the
equipment be checked by authorized service personnel at regular intervals of at least once
a year.
There are no other contraindications, however, there is the possibility of people being
sensitive to the use of ultrasound in dental treatments. The professional should always
observe the patient's reactions on the first use and assess their applicability.
1. Electrical outlets must have grounding prongs. Failure to meet this requirement may
result in damage to the equipment and, in particular, to the patient.
2. The equipment must NOT be placed in a dusty environment.
3. Direct contact with water should be avoided.
4. Do not use the equipment in the presence of flammable gases.
5. The equipment should be placed on a constant and stable platform or table. Placing
the equipment on an unstable and/or inclined table may degrade performance and/or
accidentally cause damage to the system.
6. The equipment may only be disassembled by certified technicians. Violation of this
requirement will cause immediate loss of warranty, harm to the user and/or damage to
the equipment.
7. For electrical safety, equipment cables should not be placed under heavy objects, and
should also avoid high-temperature heat sources.
If you notice any abnormal occurrences when the equipment is in use, unplug the power cord
from the wall outlet.
For a better use of all functions and to maximize the performance of the DentSurg Pro
equipment, it is suggested that before using on patients, dental surgeons should practice on
artificial models to become familiar with the use of the tips, with the movement and the ideal
force to be applied to the inserts.
A piezoelectric handpiece, such as the DentSurg Pro, causes an anteroposterior vibration
movement at the end of the insert. This movement, despite the low amplitude, has a high
Notes before use
Note to the dental surgeon
Details of the ultrasonic motion of the insert

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speed, which causes a strong impact on the front, back and top of the insert. Due to the high
precision of the movement, the impact is much smaller on the sides of the insert. This
characteristic movement defines the use of the insert.
For the CVDentus tips, the strong impact is very useful, since it cuts the dental structure
during a Cavity Preparation, however, for other applications with calculus-removal inserts,
periodontal inserts and endodontic inserts, great care must be taken to avoid direct impact of
the insert on the tooth to avoid cracking and fissures.
There are two forms of use for removing calculus:
•Tangential application - touch the side of the insert to the tooth, so the impact of the
anterior and posterior parts is directly on the calculus and not on the tooth. Apply the tip
firmly, but without pressure. Let the handpiece follow a "forward" and "backward"
movement, slow and regular.
•Frontal application –touch the front or back of the insert directly to the calculus, but never
directly against the tooth. This situation is only recommended when the layer of calculus
is thick and resistant, so that there is no risk of acting directly on the tooth. Whenever the
thickest and most resistant calculus is removed, proceed to the tangential application.
Press lightly and use a "forward" and "backward" movement, slow and regular.
For application in periodontics and endodontics, in addition to these procedures,lowand safe
potencies, recommended for the technique and for the power of each insert, should be used.
More details about these applications are available in the material sent along with the inserts
CVDentus, website (www.cvdentus.com.br) or contact the customer service ([phone]-
1126, asking for more information).
Figure 1 shows the main components of the DentSurg Pro equipment, identified by letters
A, B, C, D, E and F .
*saline not included
Description of the components
A