cvdentus Clinical PLUS User manual

INSTRUCTION MANUAL

MTP-0001 Clinical Plus - Rev.00
2
This Instruction Manual contains the information required for the correct use of CLINICAL
PLUS ultrasound equipment.
Manufacturer
Clorovale Diamantes Ind. e Com. LTDA
Estrada José Augusto Teixeira, 500 –Torrão de Ouro II
São José dos Campos / SP - Brazil
ZIP CODE: 12229-840
Phone: [phone]
website: www.cvdentus.com.br
email: [email protected]
Corporate Taxpayer’s ID: 65.478.018/0001-49
Responsible Person
LUIS FRANCISCO BONETTI
Individual’s Taxpayer ID: 270.664.418-42
Federal Council of Engineering and Agronomy (CREA): 5061621860
Product Registration with the Ministry of Health
Technical Name: Clinical Plus
Trade Name: Clinical Plus
ANVISA/MS Registration Number: 80179320007
Presentation

MTP-0001 Clinical Plus - Rev.00
3
Presentation........................................................................................................................................................ 2
Intended use of CLINICAL PLUS.................................................................................................................... 2
Contraindications to use CLINICAL PLUS .................................................................................................... 2
CLINICAL PLUS Operating Principle............................................................................................................. 2
Equipment Classification.................................................................................................................................. 2
Application Specification................................................................................................................................... 2
Notes prior to use .............................................................................................................................................. 2
Preface................................................................................................................................................................ 2
Note to Dental Surgeon.................................................................................................................................... 2
Description of Components.............................................................................................................................. 2
Control panel and main unit connectors ........................................................................................................ 2
Installation Guide............................................................................................................................................... 2
Prior to First Use................................................................................................................................................ 2
Expected Operator Distance............................................................................................................................ 2
Instructions for use and operation................................................................................................................... 2
Identification of the applied part ...................................................................................................................... 2
Details of the insert ultrasonic movement...................................................................................................... 2
Operating Procedures....................................................................................................................................... 2
Preventive Maintenance and Inspection........................................................................................................ 2
Extending Equipment Life ................................................................................................................................ 2
Cleaning and Sterilization................................................................................................................................. 2
Essential Performance...................................................................................................................................... 2
Electromagnetic Compatibility......................................................................................................................... 2
Identification of defects..................................................................................................................................... 2
Warranty.............................................................................................................................................................. 2
List of Symbols................................................................................................................................................... 2
Table of Contents

MTP-0001 Clinical Plus - Rev.00
4
Great news in ultrasonic dentistry with CVDVale technology.
CLINICAL PLUS includes two handpieces that enable frequency auto tuning in a range from
25 to 32 kHz. With the CVDentus ultrasonic tips technology, they extend the use of the
ultrasound equipment for all types of cavity preparation, offering the following benefits:
•It eliminates the noise ofthe traditional high-speed motor,improving theworking condition
of the dentist and inhibiting the possible fear of the patient.
•It is a treatment that causes less pain, reducing the need for anesthesia in most dental
treatments, as well as ensuring greater accuracy and protecting the original tooth
structure.
•As it allows dental treatment with less pain, it makes a larger portion of the population
seek preventive treatments.
•It does not cut the soft tissue, i.e., it allows subgingival treatment without anesthesia and
bleeding.
•Better final finish with a single tip. There is no need for frequent tip replacement.
•It allows access to hard-to-reach regions compared to traditional high-speed tips, or by
any other preparation technique.
•It allows better visibility during the treatment, ensuring a less-risky procedure, preserving
the healthy tissue.
•Much longer durability (if used correctly), as it is a single diamond stone chemically
bonded to the metal rod.
The CLINICAL PLUS equipment, together with the CVDentus tips, are intended for
ultrasonic dentistry. It enables a wide range of dental interventions assisted by ultrasound,
including procedures in Endodontics and Periodontics.
It has been found that electronic devices and electromedical equipment can interfere with the
normal operation of pacemaker devices.
Patients with pacemakers are recommended to avoid treatment with CLINICAL PLUS
equipment.
Presentation
Intended use of CLINICAL PLUS
Contraindications to use CLINICAL PLUS

MTP-0001 Clinical Plus - Rev.00
5
For further readings on the subject, please refer to:
- “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
CLINICAL PLUS equipment must be operated solely by a qualified dental professional,
familiar with the currently known risks and benefits of using electromedical equipment and
dental offices. No specific training is required. Reading the manual is mandatory before
use.
We recommend the professional to guide the patient or other people with access to the
equipment about the caution during its handling.
Do not attempt to repair or assemble defective or inoperative parts or replace with parts
of another device. Only by using original parts can the original technical specifications and
safety of the device be guaranteed.
To ensure the electrical safety of the device throughout its service life, the device should
be verified by the authorized service center on a regular basis of at least once a year.
There are no other contraindications, however, there may be people sensitive to the use of
ultrasound in dental treatments. The professional must always watch the patient’s reactions
at first use and evaluate its applicability.
CLINICAL PLUS is a piezoelectric ultrasound device for dental use. Inside its handpieces,
there are piezoelectric transducers that, under the action of an electrical stimulus, vibrate at
an ultrasonic frequency (between 25 and 32 kHz). This vibration is amplified by the handpiece
and transmitted to the insert, which vibrates with high intensity. The ultrasonic vibration is
used for the many processes of endodontic and periodontal cleaning and disinfection. With
the addition of CVDentus diamond tips, this vibration is used to cut hard materials such as
dentin, enamel, bone material and dental restorative materials.
ATTENTION: People with cardiac pacemakers must not be treated with
CLINICAL PLUS, or even get close to it when in operation.
CLINICAL PLUS Operating Principle

MTP-0001 Clinical Plus - Rev.00
6
WARNING
CLINICAL PLUS equipment may cause electromagnetic interference to other equipment
or electronic devices.
ATTENTION: Equipment not suitable for use in the presence of a flammable
anesthetic mix with air, oxygen or nitrous oxide.
The equipment must be connected to the power grid through an individual outlet
that has a ground port (third prong).
WARNING
Do not dispose of the equipment in household waste.
Use the appropriate disposal system as per your country’s law.
If not disposed of properly, electrical devices can pose serious risks to the
health of nature and man.
You can find collection and recycling points all over Brazil at
http://www.e-lixo.org/. If you prefer, contact CVD Vale.
ATTENTION –ULTRASONIC ENERGY NOISE:
Prolonged exposure to noise can cause physiological effects such as stress,loss
of concentration and hearing loss.
The use of hear plugs is recommended.
CLINICAL PLUS dental ultrasound equipment and its parts, including APPLIED PARTS, are
classified as follows.
Technical Specification:
•PROTECTION AGAINST ELECTRIC SHOCK:
oElectromedical equipment (CLASS I).
•MAIN UNIT:
oINPUT: 127 –220V ~ 50/60Hz 41VA –51VA;
oFuse-protected power supply (not accessible to the user);
oPower cable length: 2 meters;
oRated ultrasound power: 10W non-continuous
oDimension: width = 290mm, height =115 mm and depth =230 mm;
oWeight: 1.380 kg;
Equipment Classification

MTP-0001 Clinical Plus - Rev.00
7
oMicroprocessor circuit with internal power control;
oHardware version: 1.0 (Oct/2019) / Software version: 1.0 (Oct/2019).
oIt has initial resonance frequency search from 25to 32 kHz and with auto power
adjustment under normal operating conditions.
oAutomatic limiter for power control in case of excessive pressure on the active
tip during use in ENDO mode.
•FOOT SWITCH:
oWireless
oMicroswitch normally open, i.e. closes contact when turned on;
oEncrypted radio frequency communication;
oAcoustic signals when the battery charge level is low;
oDimensions: width = 70mm, height = 35mm and depth = 100mm;
oWeight: 0.314 kg.
oWired Version
oMicroswitch normally open, i.e. closes contact when turned on;
oCable length: 2m
oDimensions: width = 70mm, height = 35mm and depth = 100mm;
oWeight: 0.350 kg.
This product is approved by the National Telecommunications Agency
(Anatel), as per the procedures regulated by Resolution 242/2000, and
complies with the technical requirements applied (For reference:
www.anatel.gov.br).
This equipment is not entitled to protection against harmful interference
and may not cause interference to properly authorized systems.
•HANDPIECE:
oPiezoelectric with 4 PZT ceramic transducers;
o3000V Insulation / Autoclavable aluminum finish;
oNominal frequency from 25 - 32 kHz;
oApproximate length of 114mm;
oMaximum diameter of 20 mm and approximate weight of 40g.
•RATCHET WRENCH
oTool to tighten the inserts in the handpiece;
oMade of autoclavable plastic material and metal centerpiece;
oInner diameter 35mm, height 30mm, thickness 2.5mm;
oTorque 1 ± 0.1 N/m.
•PROTECTION AGAINST HARMFUL PENETRATION OF WATER OR
PARTICULATE MATTER:
oMain unit –degree of protection: IP21;
oFoot switch –degree of protection: IP21;

MTP-0001 Clinical Plus - Rev.00
8
•METHODS OF STERILIZATION:
oMoist heat sterilization (autoclave).
oCheck procedure: Cleaning and Sterilization
•OPERATING MODE:
oNon-continuous operation: “ON” 10min. on / “OFF” 5min. off;
•ENVIRONMENTAL CONDITIONS:
oTemperature: - Operation: +10ºC to +30ºC.
- Storage: +10 to +40ºC;
oHumidity - Operation: 30%
- 80% non-condensing;
- Storage: 10% - 90% non-condensing;
oAtmospheric Pressure: - Storage: 860-1060 hPa
- Operation/use: 860-1060 hPa
- Transport: 860-1060 hPa
EQUIPMENT WITH TYPE B APPLIED PART
Equipment NOT intended for use in oxygen-enriched atmosphere.
•Indication:
Procedures in.
oEndodontics,
oPeriodontics,
oDentistry,
oProsthesis.
•Target Population (Patients):
Patients of all ages.
As it does not cut soft tissue and reduces the use of anesthesia in most procedures, it can
be used on children, special patients and patients who have some kind of allergic reaction
to anesthetics.
•Contraindication:
ATTENTION: Sterilization must not be done in an oven
Application Specification

MTP-0001 Clinical Plus - Rev.00
9
Patients with pacemakers are not recommended to be treated with CLINICAL PLUS
equipment.
•Part of the body:
Used in the oral cavity for dental treatment.
•Intended user profile:
CLINICAL PLUS equipment must be operated solely by a qualified dental professional,
familiarwith the currently known risks and benefits of using electromedical equipment and
dental offices. No specific training is required. Reading the manual is mandatory before
use.
•Intended conditions of use:
CLINICAL PLUS must be used in a dental office compliant with Brazilian Sanitary
Surveillance Agency (ANVISA) sanitary standards. The office must have electrical
installations that are appropriate and dimensioned with the grounding grid.
The room must meet the hygiene and sterilization requirements as well as its furniture,
tools and other equipment.
Lighting, ventilation and temperature must meet the sanitary requirements of a dental
office.
The equipment is NOT intended for use in oxygen-enriched atmosphere.
• Estimated useful life of the equipment:
05 (five) years (respecting the guidelines described in this manual).
1. The power outlet used must be grounded. If this requirement is not met, damage to
the equipment and, above all, to the patient may occur.
2. The equipment must NOT be placed in a dusty environment.
3. Direct contact with water must be avoided.
4. Do not use the equipment in the presence of flammable gases.
5. The equipment must be placed on a steady platform or table. Placing the equipment
on an unstable and/or tilted table may degrade performance and/or accidentally
damage the system.
6. The equipment can be disassembled by certified technicians only. Failure to meet this
requirement shall cause immediate loss of warranty, damage to the user and/or
damage to the equipment.
7. For electrical safety, the equipment’s cables must not be placed under heavy objects,
and high-temperature heat sources must also be avoided.
8. If any abnormal situations are noticed when the equipment is in use, disconnect the
cable from the power grid.
Notes prior to use

MTP-0001 Clinical Plus - Rev.00
10
CLINICAL PLUS equipment was developed to achieve the maximum performance of the
handpiece together with high-precision mechanical components, causing the insert to vibrate
axially to the handpiece.
The high frequency to which the insert is subjected and using it in conjunction with a saliva
sucker enable the most resistant calculus and tartar to be removed more easily.
CLINICAL PLUS can conveniently and quickly clean the teeth and is electrically safe.
The electromechanical efficiency of this piezoelectric system is much higher than that of
traditional magnetostrictive systems. Piezoelectric systems release small amounts of heat,
make it possible to work with lower volumes of water for cooling, ensure excellent cavitation,
and make it comfortable for both patient and professional use.
It is possible to control the operating mode of power and water flow. There are two operating
modes: the constant-frequency mode, suitable for endodontic procedures, and the constant-
power mode, suitable for periodontics. This allows a very fine tune for each clinical situation.
With a wide range of tips, the unit is suitable for different types of work.
CLINICAL PLUS configuration is especially suitable to use CVDentus tips. Its circuit
operates in a self-adjusting frequency mode, which always provides the required power.
Never use with overpressure. The best protection and cutting efficiency when using
CVDentus tips is to let the tip’s own vibration promote wear, without pressing excessively.
To better use all functions and maximize the performance of CLINICAL PLUS, dentists are
recommended to practice on artificial models before using it on patients in order to be familiar
with the use of the tips, the movement and the optimal force to be applied on the inserts.
Preface
Note to Dental Surgeon