Product Overview; Technical Support; Supplies & Replacement Parts; Indications For Use - Dentsply Sirona Cavitron 300 Series Directions For Use Manual

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, 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 recom-
mendations 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
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assembling them for use.
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