Introduction; Indications For Use; Contraindications; Warnings - DENTSPLY Cavitron Steri-Mate Mode D'emploi

INTRODUCTION

The Cavitron Steri-Mate Handpiece Sterile Lavage Kit
® ®
is an accessory for Cavitron
®
the 30K Steri-Mate Sterilizable Handpiece. This kit is
®
intended to provide the clinician with a method to use
sterile lavage with a Cavitron
®
The kit consists of a Pressurized Infuser bag and
a Steri-Mate Handpiece Adapter. The Pressurized
Infuser bag can be hung from a standard IV pole or
similar device. The Steri-Mate Handpiece Adapter is
easily installed between the handpiece cable and the
Steri-Mate Handpiece. The adapter does not affect
the operation of the Cavitron
®
Handpiece.
SECTION 1:

Indications For Use

The Steri-Mate Handpiece Sterile Lavage Kit is indicated
for use with the DENTSPLY Cavitron Ultrasonic Scaler
in general prophylaxis and periodontal treatments and
other areas of operative dentistry for supragingival and
subgingival removal of calculus, plaque, and stains from
teeth with sterile fluid delivery.
SECTION 2:

Contraindications

• Cavitron Ultrasonic Scaling systems should not
®
be used for restorative dental procedures
involving the condensation of amalgam.
SECTION 3:

Warnings

• Not for use with any ultrasonic scaling systems
other than Cavitron Systems.
®
• Not for use with Cavitron
®
systems, unless equipped with the Steri-Mate
Handpiece.
• 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 a known antimicrobial such as
Chlorhexidine Gluconate 0.12%. Rinsing with
an antimicrobial reduces the chance of infec-
tion and reduces the number of microorganisms
the patient might release in the form of aerosols
during treatment.
Ultrasonic Scalers that use
Ultrasonic Scaler.
unit or the Steri-Mate
ultrasonic scaling
• 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;
- the applicable industry and governmental
agency recommendations for infection control
in dental healthcare settings,
- the requirements, and regulations for the safe
practice of dentistry; and
- these Directions for Use in their entirety.
• 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 at least 6 inches (15 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
detailed information about the device.
• Directions for Use are not intended to advise
Dental Healthcare Professionals on the practice
of dentistry.
SECTION 4:

Precautions

4 1 System Precautions

• The Steri-Mate Handpiece Sterile Lavage Kit will
deliver sterile lavage with a Cavitron® Ultrasonic
Scaler equipped with a Steri-Mate Handpiece
provided the following conditions exist: the container
of lavage fluid is sterile; the IV administration set
used to connect the lavage fluid container to the
Sterile Lavage Adapter is sterile; the Sterile Lavage
Adapter, Steri-Mate Handpiece, and Cavitron
Ultrasonic Insert have been sterilized by steam
autoclave as indicated in the manufacturer's
Directions For Use; the components (container
of lavage fluid, IV administration set, Sterile
Lavage Adapter, Steri-Mate Handpiece, and
Cavitron Ultrasonic Insert) are assembled under
aseptic conditions.
• Do not place on or next to a radiator or other
heat source. Excessive heat may cause
damage. Place the system where air is free to
circulate on all sides and beneath it.
• The Sterile Lavage Kit bypasses the Cavitron
system's internal lavage path. Equipment
flushing and dental water supply system
maintenance are strongly recommended for
®
3