Indications For Use; Contraindications; Warnings; 1 .System .Precautions - Cavitron Plus Mode D'emploi

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
• 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 .
• The use of High Volume Saliva Evacuation to reduce
the quantity of aerosols released during treatment is
highly recommended.
• 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 industry
and governmental agency recommendations,
requirements, and regulations for safe practice of
dentistry.
• Where asepsis is required or deemed appropriate in
the best professional judgment of the Dental Healthcare
Professional, this product should not be used.
• 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.
• 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.
• 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.
SECTION 4: precautions
4.1 System precautions
• 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 9:
System Care.
• Close manual shut-off valve on the dental office water
supply every night before leaving the office.
• The use of an in-line water filter is recommended.
• Never operate system without fluid flowing through
handpiece.
4.2 procedural precautions
• The Cavitron Plus unit works with Cavitron inserts as
a system, and was designed and tested to deliver
maximum performance for all currently available Cavitron
and Cavitron Bellissima™ 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 inserts before using in a clinical
setting.
• Like bristles of a toothbrush, ultrasonic insert tips "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
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