DENTSPLY Steri-Mate Light Handbuch

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®

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.

• 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

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

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

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.

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