S-19-01-1214-UV101 V1.3
Section 5: Contraindications and Warnings
5.1 Contraindications
‧ Ultrasonic Systems should not be used for
restorative dental procedures involving the
condensation of amalgam.
‧ This device is designed to work with all Cavitron
®
(remark) insert with 25Khz or 30Khz frequency
automatically. For optimum performance please
use only qualified inserts supplied by Cavitron
®
or
Rolence
®
.
‧ Do not use this device if the patient or operator is
wearing a pacemaker.
Remark: Cavitron
®
is a registered trademark of
Dentsply
®
International, Inc
5.2 Warnings
‧ Persons who are 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. We recommend that the
handpiece and tubing be kept at least 6 to 9
inches (15 to 23 cm) away from any device and
their leads during use.
‧ During using the unit, make sure that water is
flowing continuously. If the handpiece overheats
please check the water supply, and stop using the
unit for a while.
Section 6: Infection Control
6.1 General Infection Control
Recommendations
‧ As with all dental procedures, the use of standard
personal protection equipment (i.e., wearing a
face mask, eyewear, or face shield, gloves and
protective gown) is recommended.
‧ For maximal operator and patient safety, carefully
follow section 11 system maintenance and care
information detailed in the operating instruction
accompanying your ultrasonic scaler.
‧ As with high speed handpieces, and other dental
devices, the combination of water and ultrasonic
vibration from your ELiTEDENT
®
Ultrasonic Scaler
will create aerosols. With proper technique, much
of the aerosol dispersion can be effectively
controlled and minimized. Please carefully follow
the procedural guidelines in this manual
regarding the use of your ultrasonic scaler.
‧ Always flush your ELiTEDENT
®
Ultrasonic Scaler
with highest flow before treatment. Refer to more
information in section 10.
‧ Clean and disinfect the handpiece sleeve between
patients. The handpiece sleeve can be autoclaved
up to 135℃ for at least 3 minutes.
Sterilizing:
1. Place handpiece sleeve and pouched ultrasonic
insert into a steam autoclave. After warm-up is
completed, operate at a sterilizing temperature
and pressure of 273° F/31 psi (134°C/216 kPa)
for 12 minutes, followed by a 20-30 minute
drying time.
2. To maintain sterility, the insert should remain in
the sealed pouch until it is ready for use.
DO NOT USE Cold sterilization solution.
6.2 Water Supply Recommendations
‧ It is highly recommended that all dental water
supply systems should 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 6.1 and
11.
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