Indications For Use; Contraindications; Warnings; System Precautions - Dentsply Sirona Cavitron Plus Directions For Use Manual

SECTION 1:

Indications For Use

• All general supra and subgingival scaling applications
• Periodontal debridement for all types of periodontal
diseases
• Endodontic procedures
SECTION 2:

Contraindications

• Ultrasonic Systems should not be used for restorative
dental procedures involving the condensation of
amalgam.
SECTION 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).
• 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, 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 7.1 and with sufficient water flow, the water and
tip temperature should not exceed 50
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.
SECTION 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. See Section
10: System Care.
• Never operate system without fluid flowing through the
handpiece.
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