Product Overview; Technical Support; Supplies & Replacement Parts; Indications For Use - Dentsply Sirona Cavitron 300 Série Mode D'emploi

CAUTION: United States Federal Law
restricts this device to sale by or on the
order of, a licensed dental professional.
For dental use only.

Product Overview

The Cavitron 300 Series Ultrasonic Scaling System offers an
®
advanced experience at your fingertips. The unit features a
modern touch screen interface for ease of use with added
memory presets and customizable power settings for improved
efficiency. The system also features a lightweight, detachable
handpiece cord for improved ergonomics and Steri-Mate 360
rotating handpiece.

Technical Support

For technical support and repair assistance in the U.S., call
the Dentsply Sirona Cavitron Care Factory Certified Service
at 1-800-989-8826, Monday through Friday, 8:00 A.M. to
5:00 P.M. (Eastern Time). For other areas, please see back
cover for repair centers or contact your local Dentsply Sirona
representative.
Supplies & Replacement Parts
To order supplies or replacement parts in the U.S., contact your
local Dentsply Sirona Distributor or call 1-800-989-8826, Monday
through Friday, 8:00 A.M. to 5:00 P.M. (Eastern Time). For other
areas, contact your local Dentsply Sirona Representative.

1. Indications For Use

USED FOR ULTRASONIC PROCEDURES:
• All general supra and subgingival scaling applications
• Periodontal debridement for all types of periodontal diseases

2. Contraindications

• Ultrasonic Systems should not be used for restorative dental
procedures involving the condensation of amalgam.
• Not for use on children under the age of 3.

3. Warnings

• The use of High Volume Saliva Evacuation to reduce the
quantity of aerosols released during treatment is highly
recommended.
• Prior to beginning treatment, patients should rinse with an
antimicrobial such as Chlorhexidine Gluconate 0.12%. Rinsing
with an antimicrobial reduces the chance of infection and
reduces the number of microorganisms released in the form of
aerosols during treatment.
• It is the responsibility of the Dental Healthcare Professional
to determine the appropriate uses of this product and to
understand:
– the health of each patient,
– the dental procedures being undertaken,
– and applicable industry and governmental agency
recommendations for infection control in dental healthcare
settings,
– requirements, and regulations for safe practice of dentistry; and
– these Directions for Use in their entirety, including Section
4 Precautions, Section 6 Infection Control, and Section 10
System Care.
• Where asepsis is required or deemed appropriate in the best
professional judgment of the Dental Healthcare Professional,
this product should not be used, unless used in combination
with a sterile lavage kit (P/N 81340).
• Handle Cavitron ® insert with care. Improper handling of insert,
specifically the insert tip, may result in injury and/or cross
contamination.
• Failure to follow properly validated sterilization processes and
approved aseptic techniques for Cavitron inserts or handpieces
may result in cross contamination.
• Persons fitted with cardiac pacemakers, defibrillators and other
active implanted medical devices, have been cautioned that
some types of electronic equipment might interfere with the
operation of the device. Although no instance of interference
has ever been reported to Dentsply Sirona, we recommend that
the handpiece and cables be kept 6 to 9 inches (15 to 23 cm)
away from any device and their leads during use.
• There are a variety of pacemakers and other medically
implanted devices on the market. Clinicians should contact
the device manufacturer or the patient's physician for specific
recommendations. This unit complies with IEC 60601 Medical
Device Standards.
• Insufficient water flow could result in elevated water and tip
temperature. When operated at the input water temperature
specified in the Water Line Requirements Section and with
sufficient water flow, the water and tip temperature should
not exceed 50° C (122° F). Failure to follow recommendations
for environmental operating conditions, including input water
temperature, could result in injury to patients or users. If
temperature is elevated, increase water flow. If temperature
remains elevated, discontinue use.
• During boil-water advisories, this product should not be
operated as an open water system (e.g. connected to a public
water system). A Dental Healthcare Professional should
disconnect the system from the central water source. The
Cavitron DualSelect™ system can be attached to this unit and
operated as a closed system until the advisory is cancelled.
When the advisory is cancelled, flush all incoming waterlines
from the public water system (e.g. faucets, waterlines and
dental equipment) in accordance with the manufacturer's
instructions for a minimum of 5 minutes.
• Per FCC Part 15.21, changes or modifications not expressly
approved by the party responsible for compliance could void
the user's authority to operate this equipment.
• This portable transmitter with its antenna complies with FCC/IC
RF exposure limits for general population / uncontrolled exposure.
• This Device complies with Industry Canada License-exempt
RSS standard(s). Operation is subject to the following two
conditions: 1) this device may not cause interference, and 2)
this device must accept any interference, including interference
that may cause undesired operation of the device.

4. Precautions

4.1 System Precautions
• Close manual shut-off valve on the dental office water supply
every night before leaving the office.
• Do not place the system on or next to a radiator or other heat
source. Excessive heat may damage the system's electronics.
Place the system where air is free to circulate on all sides and
beneath it.
• The system is portable, but must be handled with care when
moving.
• Equipment flushing and dental water supply system maintenance
are strongly recommended.
• Never operate system without fluid flowing through the
handpiece.
• Always ensure that the electrical connections on the handpiece
cable and the Steri-Mate handpiece are clean and dry before
®
assembling them for use.
* data on file
4.2 Procedural Precautions
GENERAL
• As with all dental procedures, use universal precautions (i.e., wear
face mask, eyewear, or face shield, gloves and protective gown).
ULTRASONICS
• The Cavitron Ultrasonic Scaling System works with Cavitron
inserts as a system, and was designed and tested to deliver
maximum performance for all currently available Cavitron
brand ultrasonic inserts. Companies that manufacture, repair
or modify inserts carry the sole responsibility for proving the
efficacy and performance of their products when used as a part
of this system. Users are cautioned to understand the operating
limits of their insert before using in a clinical setting.
• Like bristles of a toothbrush, ultrasonic inserts "wear" with use.
Inserts with just 2 mm of wear lose about 50% of their scaling
efficiency. In general it is recommended that ultrasonic inserts
be discarded and replaced after one year of use to maintain
optimal efficiency and avoid breakage.
• If excessive wear is noted, or the insert has been bent, reshaped
or otherwise damaged, discard the insert immediately.
• Ultrasonic insert tips that have been bent, damaged, or
reshaped are susceptible to in-use breakage and should be
discarded and replaced immediately.
• Retract the lips, cheeks and tongue to prevent contact with the
insert tip whenever it is placed in the patient's mouth.

5. Adverse Reactions

None Known.

6. Infection Control

6.1 General Infection Control
• For operator and patient safety, carefully practice the infection
control procedures detailed in the Cavitron Systems Infection
Control Procedures booklet accompanying your system.
Additional booklets can be obtained by calling Customer
Service at 1-800-989-8826, Monday through Friday, 8:00 A.M.
to 5:00P.M. (Eastern Time). For areas outside the U.S., contact
your local Dentsply Sirona representative.
• As with high speed handpieces and other dental devices, the
combination of water and ultrasonic vibration from the Cavitron
Ultrasonic Scaler will create aerosols. Following the procedural
guidelines in Section 9 of this manual can effectively control
and minimize aerosol dispersion.
6.2 Water Supply Recommendations
• It is highly recommended that all dental water supply systems
conform to applicable CDC (Centers for Disease Control and
Prevention) and ADA (American Dental Association) standards,
and that all recommendations be followed in terms of flushing,
chemical flushing, and general infection control procedures. See
Sections 7.1 and 10.
• As a medical device, this product must be installed in
accordance with applicable local, regional, and national
regulations, including guidelines for water quality (e.g. drinking
water). As an open water system, such regulation may require
this device to be connected to a centralized water control
device. The Cavitron DualSelect Dispensing System may be
installed to allow this unit to operate as a closed water system.

7. Installation Instructions

Anyone installing a Cavitron System should observe the following
requirements and recommendations.
7.1 Water Line Requirements
• A water supply line with user-replaceable filter is supplied
with your system. See Section 10 System Care for replacement
instructions.
• Incoming water supply line pressure to the system must be 20
psi (138 kPa) to 40 psi (275 kPa). If your dental water system's
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supply line pressure is above 40 psi, install a water pressure
regulator on the water supply line to your Cavitron Ultrasonic
Scaler.
• A manual shut-off valve on the dental water system supply line
should be used so that the water can be completely shut-off
when the office is unoccupied.
• In addition to the water filter supplied, it is recommended that
a filter in the dental water system supply line be installed so
that any particulates in the water supply will be trapped before
reaching the Cavitron system.
• After the above installations are completed on the dental
water supply system, the dental office water line should be
thoroughly flushed prior to connection to the Cavitron system.
• Incoming water temperature to the Cavitron System should not
exceed 25˚C (77˚F). If needed a device should be installed to
maintain a temperature within this specification, or a Cavitron
DualSelect Dispensing System attached to allow this system to
be operated as a closed water system.
7.2 Electrical Requirements
• Incoming power to the system must be 100 volts AC to 240
volts AC, single phase 50/60 Hz capable of supplying 1.0 amps.
• The system power should be supplied through the AC power
cord provided with your system.
• WARNING: To avoid risk of electric shock, this equipment must
only be connected to a supply mains with protective earth.
7.3 Unpacking the System
Carefully unpack your Cavitron Ultrasonic Scaling System and
verify that all components and accessories are included:
1. Cavitron 300 Series Ultrasonic Scaler with Detachable
Featherweight Handpiece Cable
2. Water Line Assembly (Blue) with Filter and Quick Disconnect
3. Additional Water Line Filter
4. Detachable AC Power Cord
5. Cavitron Tap-On™ Wireless Foot Pedal
®
6. Auxiliary Cable for Rechargable Foot Pedal
7. Steri-Mate ® 360 Detachable Sterilizable Handpiece
8. Literature Packet
7.4 System Installation
• The Cavitron System is designed to rest on a level surface. Be
sure unit is stable and resting on four feet.
• The Cavitron System should not be positioned such that access
to the power input and AC power cord are limited.
• Placing unit in direct sunlight may discolor plastic housing.
• The system has been equipped with a Tap-On Wireless Foot
Pedal which was factory synchronized to operate with the
system base unit. If your office has more than one Cavitron
system with Tap-On Technology, it is recommended that you
mark the Tap-On Foot Pedal and base unit for easy reference
as to which Tap-On Foot Pedal operates with which base unit.
Should resynchronization be necessary, follow the instructions
in section 7.9.
7.5 Power Cord Connection
• Verify the Main Power ON/OFF switch, located at the rear of
the System, is set to the OFF (O) position before proceeding.
• Insert the AC power cord into the power input on the back of
the System.
• Insert the pronged plug into an AC wall outlet.
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