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Table of Contents
Introduction
Product Overview
Technical Support
Supplies and Replacement Parts
Indications for Use
Contraindications
Warnings
Precautions
Adverse Reactions
Residual Risks
Infection Control
Installation Instructions
Cavitron Plus Ultrasonic Description
System Setup, Operation and Techniques for Use
System Care
Troubleshooting
Warranty Period
Specifications
Symbol Identification, Classification, Disposal of Unit
Electro-Magnetic Compatibility Precautions
Introduction
Dentsply Sirona is an ISO 13485 registered company. All
Dentsply Sirona medical devices sold in Europe are CE
marked in conformance with Council Directive 93/42/
4
EEC.
Caution: United States Federal Law restricts this device to
4
sale by or on the order of, a licensed dental professional.
For dental use only.
4
Product Overview
4
The Cavitron
Plus Ultrasonic Scaler is a precision
®
engineered and manufactured instrument. It contains
controls and components for ultrasonic scaling. The
4
system produces 30,000 strokes per second at the
ultrasonic insert's working tip that when combined with
the cavitational effect of the coolant lavage creates a
4
synergistic action that is designed to "power away" even
the heaviest calculus deposits while maintaining operator
and patient comfort.
4-5
The Cavitron Plus Ultrasonic Scaler is equipped with the
Sustained Performance System™ (SPS Technology), which
5
offers a constant balance between scaling efficiency and
patient comfort by maintaining power when the insert
tip encounters tenacious deposits, allowing the clinician
5
to effectively scale even at a decreased/lower power
setting. The Cavitron Plus System has extended the SPS
technology by expanding the Blue Zone range, providing
5-6
finer resolution to the power settings.
Advanced features that include a Tap-On ™ Wireless Foot
Pedal with Tap-On™ Technology, Turbo Mode, illuminated
6
diagnostic display, rinse setting, automated purge
function, Steri-Mate
®
detachable sterilizable handpiece,
and 330˚ swivel handpiece cable with more precise
6-8
lavage water control. These features, combined with a
low power range (Blue Zone™) and hands-free Boost
9-12
Mode, are designed to deliver a positive ultrasonic scaling
experience for your patients while providing your practice
with the quality and reliability you've come to expect from
12-13
Cavitron brand ultrasonic systems.
The Cavitron Plus Ultrasonic Scaler is UL/ULC certified
and approved. The Cavitron Plus Ultrasonic Scaler is
13-14
classified by Underwriters Laboratories Inc. with respect
to electric shock, fire, mechanical hazards in accordance
15
with the IEC 60601 Standard. The Cavitron Plus Ultrasonic
Scaler complies with Part 15 of the FCC Rules. Operation
is subject to the following two conditions: 1) this device
16
may not cause harmful interference, and 2) this device
must accept any interference received, including
interference that may cause undesired operation. Cavitron
16
Plus base FCC certification/registration number: FCC ID:
TF3-DPD81842; IC: 4681B-DPD81842. Cavitron Plus Tap-
On ™ Foot Pedal FCC certification/registration number:
17-18
FCC ID: TF3-DPD81861; IC: 4681B-DPD81861. The term IC
before the certification/registration number signifies that
the Industry Canada technical specifications were met.
18
Technical Support
For technical support and repair assistance in the U.S.,
call the Dentsply Sirona Cavitron Care
Service at 1-800-989-8826, Monday through Friday, 8:00
A.M. to 5:00 P.M. (Eastern Time). For other areas, please
visit www.dentsplysirona.com/eifu and search "Cavitron
Repair Centers".
English - 3
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, please see back cover
for repair centers or contact your local Dentsply Sirona
representative.
1: Indications For Use
•
All general supra and subgingival scaling applications
•
Periodontal debridement for all types of periodontal
diseases
•
Endodontic procedures
2: Contraindications
•
For best performance, use only ultrasonic inserts
manufactured by Dentsply Sirona.
•
Ultrasonic Systems should not be used for restorative
dental procedures involving the condensation of
amalgam.
3: Warnings
•
The use of High Volume Evacuation (HVE) to
manage aerosols during the procedure is highly
recommended.
•
The effectiveness of pre-procedural rinses has
yet to be fully determined in clinical research.
However, the use of mouth rinses containing:
Chlorhexidine Gluconate, Hydrogen peroxide,
povidone iodine and essential oils, may reduce the
number of microorganisms during aerosol generating
procedures.
•
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 Instructions for Use in their entirety, including
Section 4 Precautions, Section 7 Infection Control,
and Section 11 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.
Factory Certified
SM
•
Handle Cavitron insert with care. Improper handling
* data on file
English - 4
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