DENTSPLY Steri-Mate Light Manual

Directions for Use / Mode D’Emploi / Instrucciones de Uso /
Gebrauchsanleitung / Istruzioni per L’Uso / УКАЗАНИЯ ПО ПРИМЕНЕНИЮ
Steri-Mate™Light
Lighted Sleeve for Steri-Mate®Handpieces
Manchon d’éclairage pour pièces à main Steri-Mate®
Funda con linterna para piezas de mano Steri-Mate®
Beleuchtete Hülle für Steri-Mate®Handstücke
Manicotto con Lampada per manipoli Steri-Mate®
Внешний корпус с осветителем для наконечников Steri-Mate®

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INTRODUCTION
The Steri-Mate™ Light is a steam autoclave
sterilizable multi-use disposable accessory for the
30K Steri-Mate®sterilizable handpiece. The light
easily slides on the Steri-Mate handpiece for use
with all 30K Cavitron®Inserts. The light provides
optimal light intensity without requiring an external
power source and operates at all power settings
including the low power Cavitron Blue Zone.
• Provides illumination to enhance visibility in the
clinical working area during ultrasonic scaling
procedures with the Steri-Mate handpiece.
• When the Steri-Mate™ Light is installed on the
Steri-Mate handpiece, the soft tapered grip
provides multiple pinch points, to enhance
ergonomics and improve clinician comfort.
• The Steri-Mate™ Light is sterilizable which
reduces the risk of cross contamination.
• Ultrasonic systems should not be used for
restorative dental procedures involving the
condensation of amalgams.
• Persons fitted with cardiac pacemakers,
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INDICATIONS FOR USE
CONTRAINDICATIONS
WARNINGS

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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 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 detailed information
about the device.
• It is the responsibility of the Dental Healthcare
Professionals (DHCP) to determine the appropriate
uses of this product and to understand the health
of each patient, the dental procedures being under-
taken, and industry and governmental agency
recommendations, requirements, and regulations
for safe practice of dentistry.
• It is suggested that 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 micro-
organisms the patient might release in the form of
aerosols during treatment.

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• DO NOT USE if the LED light guide insulation is
torn or damaged exposing electrical conductors.
Discard the Lighted Sleeve immediately.
• Sterilize before use. Follow the infection control
procedures carefully.
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PRECAUTIONS
STERI-MATE™LIGHT DESCRIPTION
LED Flexible Light Guide
Insert Port Soft Sleeve Date Code
(see example)
Example Date Code
(January 2007)
Handpiece Port

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INSTALLATION INSTRUCTIONS
1. Sterilize before installation, following the Infection
Control Procedures.
2. Place the handpiece port of the sleeve over the
top of the Handpiece and slide the sleeve on the
Steri-Mate handpiece until fully seated.
3. Lubricate the o-ring on the insert with water. Fill
the entire Steri-Mate handpiece with water.
Gently twist the insert down into the Steri-Mate
handpiece until the insert is fully seated in place.
DO NOT FORCE.
1. Rotate the sleeve to direct the light to the desired
position.
2. The flexible light guide is adjustable to improve
visibility of the clinical working area.
3. The Steri-Mate™ Light is now ready for use. To
activate the LED, depress the foot control.
DIRECTIONS FOR USE

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WARNINGS
• The Steri-Mate™ Light is not sterile upon receipt
and must be sterilized prior to use in accordance
with the following instructions.
• The Lighted Sleeve must be disassembled from
the Handpiece prior to autoclaving. Not following
this procedure will result in defective cosmetic
appearance.
• The colorant used on the sleeve may bleed and
discolor during autoclaving. This will not affect
performance.
• Allow the Lighted Sleeve and the Handpiece to
cool after autoclaving for proper assembly.
LIMITATIONS ON PROCESSING
• The Steri-Mate™ Light is designed to withstand a
minimum of 100 autoclave cycles. When
illumination of the LED begins to diminish or if the
insulation is torn or damaged, replace the Lighted
Sleeve.
• Do not use chemical disinfectants prior to
sterilization or rapid deterioration of the materials
may occur.
• Cold liquid disinfection/sterilization, chemical vapor
sterilization, and dry heat sterilization methods
have not been tested or validated for efficacy and
are not recommended for use.
• Do not immerse the Lighted Sleeve in an
ultrasonic bath.
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INFECTION CONTROL PROCEDURES

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INSTRUCTIONS
Point of use:
Remove excess soil with disposable cloth or paper.
Containment and Transportation:
Protect the LED from damage. Reprocess as soon
as is reasonably practical following use. Lighted
Sleeves left standing wet may stain.
Cleaning: manual
• Disassemble the Lighted Sleeve from the
Handpiece. Rinse under running water to remove
any gross debris.
• Wipe Handpiece and Lighted Sleeve with a cloth
saturated with multi-purpose cleaner and rinse
with running water. Discard used cloth. Dry with
a clean cloth.
Disinfection:
Disinfection of the Steri-Mate™ Light is not
necessary prior to steam autoclave sterilization.
Packaging:
With Lighted Sleeve and Handpiece disassembled,
place instruments into a paper or paper/plastic
steam sterilization pouch. The instruments may be
loaded into dedicated instrument trays.
Sterilization:
Use a steam autoclave. Place bagged instruments
into the steam autoclave, paper side up when using
a paper/plastic pouch. After warm-up is completed,
operate at a sterilizing temperature and pressure
of 273ºF/134ºC to 279ºF/137ºC and pressure of
31psi/216kPa for 3 to 12 minutes.
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Alternate method: Place non-bagged instruments
into the steam autoclave. After warm-up is
completed, operate at a sterilizing temperature
and pressure of 273ºF/134ºC to 279ºF/137ºC and
pressure of 31psi/216kPa for 3 to 4 minutes. The
instruments should be used immediately after drying.
Drying:
To dry, use the drying cycle of the autoclave. Set
cycle for 20-30 minutes. Allow instruments to cool
before use.
Maintenance, Inspection and Testing:
• Visually inspect to ensure all contamination is
removed.
• Check for distortion, damage and wear. Discard
damaged, worn or corroded instruments.
Storage:
To maintain sterility, instruments should remain
bagged until ready for use.
In the United States, contact DENTSPLY
Professional Customer Service Technical Support
at 800-989-8826. For areas outside the United
States, contact your local DENTSPLY Professional
Representative.
The Cavitron®Steri-Mate™ Light manufactured
by DENTSPLY®Professional is warranted against
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MANUFACTURER CONTACT
WARRANTY

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defects arising from faulty materials or workmanship
for thirty days from the date of purchase. This
warranty extends to product purchased from an
authorized DENTSPLY distributor and only to
the original purchaser and is valid only for Lights
purchased in the United States (U.S.) and for those
countries without specific warranty requirements.
For Lights purchased outside the U.S. in countries
with specific warranty requirements, those
applicable country warranties will apply. This
warranty is subject to the following conditions:
1) Lights must not be subjected to abuse or
improper use or application;
2) Lights must not be subjected to abuse or
improper cleaning, disinfection, or sterilization
procedures;
3) Using Steri-Mate™ Lights on handpieces other
than Cavitron Steri-Mate handpieces will void
this warranty.
There are no warranties, expressed or implied
beyond the description on the face hereof.
DENTSPLY neither assumes, nor authorizes any
person to assume for it, any other liability for
incidental and consequential damages resulting
from the use of the insert.
To receive reimbursement for any defective Cavitron
Steri-Mate™ Light, you must send the defective
product within the warranty period to the dealer or
manufacturer with specification of the defect and
receipt of purchase.
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FRANçAIS
INTRODUCTION
La lampe Steri-Mate™ est un accessoire jetable
multi usages stérilisable en autoclave ; elle est
conçue pour être utilisée avec les pièces à main
stérilisables Steri-Mate™. Il suffit de faire glisser
la lampe sur la pièce à main Steri-Mate™, cet
assemblage étant par la suite utilisable avec
les inserts 30K Cavitron®. La lampe donne un
éclairage d’une intensité optimale sans nécessiter
de source d’alimentation externe et s’adapte à
toutes les puissances ; elle fonctionne notamment
avec le Blue Zone Cavitron®dont la consommation
d’énergie est faible.
APPLICATIONS
• La lampe permet d’éclairer efficacement les
zones de soins cliniques dans le cadre de
procédures de détartrage à ultrasons avec la
pièce à main Steri-Mate™.
• Une fois la lampe Steri-Mate™ mise en place
sur la pièce à main Steri-Mate™, le praticien
appréciera sa conception ergonomique grâce au
revêtement souple pourvu de nombreux points
en relief.
• La lampe Steri-Mate™ est stérilisable, ce qui
permet d’éviter les risques de contamination
croisée.