DENTSPLY Cavitron Built-In Steri-Mate G90, Directions For Use Manual

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ENGLISH • 5 ENGLISH • 4
Professional Insert Efficiency Indicator is enclosed for your use.
• 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.
• Water should be used for all scaling procedures. Water flow is
adjustable from less than 10 to greater than 60 ml per minute.
• Only adjust the systems’s power adjustment knob with the insert
outside the patients mouth.
• As with all dental procedures, use universal precautions (i.e.,
wear face mask, eyewear, or face shield, gloves, and protective
gown).
Section 5: Adverse Reactions
None known.
Section 4: Precautions
• Equipment flushing and dental water supply system
maintenance are strongly recommended. See Section 11:
System Care.
• Verify handpiece fits properly in the dental delivery system
holder. If not properly seated, there is a potential for the
handpiece to slip out of the holder and be damaged or
contaminated. Contact a service technician to have an adapter
installed on your Cavitron handpiece cable.
• 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.
• Always ensure that the electrical connections on the handpiece
cable and the Steri-Mate® Handpiece are clean and dry before
assembling them for use.
• Cavitron ultrasonic scaling units and Cavitron ultrasonic inserts
are designed and tested for safety and efficacy as a system.
Use of any other brand ultrasonic equipment with Cavitron
equipment has not been tested and may have a negative effect
on the safety and effectiveness of your Cavitron equipment and
their warranties. Please review the warranty statement enclosed
before use.
• 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 breakage. A DENTSPLY
• 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 11 System Care.
• This product is designed to assist in eliminating susceptibility
to retraction of oral fluids. To ensure adequate protection
from cross-contamination from other devices connected to the
Dental Unit, it is highly recommended that the Dental Unit be
installed with anti-retraction features. Additionally, the Dental
Unit, including the anti-retraction features, must be properly
maintained and periodically tested. For more information,
please contact your Dental Unit manufacturer.
• 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).
• During boil-water advisories, this product should not be operated
as an open water system (e.g. connected to a public water
system). Dental Healthcare Professionals should discontinue use
on patients and contact the local water authority to determine
when it is safe to continue use of this product. When the
advisory is cancelled, the local water authority should provide
guidance for flushing of waterlines. All incoming waterlines
from the public water system inside the dental office (e.g.,
faucets, waterlines, and dental equipment) should be flushed in
accordance with manufacturer’s instructions for a minimum of
5 minutes.
• Prior to beginning treatment, patients should rinse with a known
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.
• The use of High Volume Saliva Evacuation to reduce the
quantity of aerosols released during treatment is highly
recommended.
• Failure to follow recommendations for environmental operating
conditions, including input water temperature, could result in
injury to patients or users.
• 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 may result in
cross contamination.
• DO NOT mount the Cavitron Built-In Scaler outside of the
Dental Unit; doing so will void the warranty.