DENTSPLY Cavitron G139 Handbuch

Cavitron®Built-In G139

Directions For Use

Mode d’emploi

Instrucciones de uso

Gebrauchsanweisung

Istruzioni per l’uso

Инструкция по эксплуатации

Ultrasonic Scaler with Cavitron®Steri-Mate®Handpiece

Détartreur ultrasonique avec pièce à main Cavitron®Steri-Mate®

Escarificador ultrasónico con pieza de mano Cavitron®Steri-Mate®

Ultraschall-Zahnsteinentfernungsgerät mit Cavitron®Steri-Mate®Handstück

Scaler a ultrasuoni con manipolo Cavitron®Steri-Mate®

Ультразвуковая система для удаления зубного камня

с наконечником Cavitron®Steri-Mate®

ENGLISH • 2

ENGLISH • 1

Introduction

The Cavitron Built-In Ultrasonic Scaler is equipped with a Sustained

Performance System™ (SPS), which offers a constant balance

between scaling efficiency and patient comfort by maintaining the

unit's power level when the insert tip encounters tenacious deposits

allowing the clinician to effectively scale even at a decreased/lower

power setting.

The System operates by converting an SELV source current into

high frequency current. The ultrasonic system consists of two

parts: an insert and the SPS electronic system. The SPS system

incorporates two closed loops. One loop provides automatic tuning

(operating frequency is adjusted to be at resonance for each insert).

The second loop automatically controls the tip stroke over different

working conditions. The DENTSPLY Cavitron Built-In scaler

produces 30,000 microscopically small strokes per second at the

insert’s working tip. This, combined with acoustic effects of the

coolant water, produces a synergistic action that literally “powers

away” the heaviest calculus deposits while providing improved

operator and patient comfort.

ENGLISH

Cavitron®Built-In Ultrasonic Scaler

with Cavitron®Steri-Mate®Handpiece

Model G139

Directions for Use

Please read carefully and completely before operating

unit.

ENGLISH • 2

1. Indications For Use.......................................................................................................3

2. Contraindications ..........................................................................................................3

3. Warnings .......................................................................................................................3–4

4. Precautions....................................................................................................................5

5. Adverse Reactions ........................................................................................................5

6. Infection Control...........................................................................................................6

6.1 General Information

6.2 Water Supply Recommendations

7. Water Line Requirements .............................................................................................6

8. Ultrasonic Scaler System Description ..........................................................................7–10

8.1 System Controls

8.2 Steri-Mate®Handpiece

8.3 DENTSPLY Cavitron®30K™ Ultrasonic Inserts

8.4 Foot Control Information & Operation

9. Techniques for Use .......................................................................................................10–11

9.1 Patient Positioning

9.2 Performing Ultrasonic Scaling Procedures

9.3 Patient Comfort Considerations

10. System Care ..................................................................................................................11–12

10.1 Daily Protocol

11. Troubleshooting ............................................................................................................13–16

12. Warranty Period ............................................................................................................17

13. Specifications................................................................................................................17

14. Classifications...............................................................................................................18

15. Symbol Identification ...................................................................................................18

Table of Contents

Section Section Title/Description of Contents Page Number

ENGLISH • 3

Section 1: Indications for Use

Ultrasonic Procedures

• All general supra and subgingival scaling applications.

• Periodontal debridement for all types of periodontal diseases.

Section 2: Contraindications

• Ultrasonic Systems should not be used for restorative

procedures involving condensation of amalgam.

• Not for use on children under the age of 3.

Section 3: Warnings

• 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 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 specific

recommendations. This unit complies with IEC 60601 Medical

Device Standards.

Product Overview

This product is intended for installation into a dental system. The

end users are dental professionals. The devices are used to debride

light to heavy calculus deposits from the tooth and root surfaces.

Technical Support

For technical support and repair assistance in the U.S.,

call a Cavitron CareSM representative at 1-800-989-8826 or

717-767-8502 Monday through Friday, 8:00 AM to 5:00 PM

(Eastern Time). For other areas, contact your local DENTSPLY

representative.

Supplies & Replacement Parts

To order supplies and replacement parts in the U.S., contact your

local DENTSPLY distributor or call 1-800-989-8826 or

717-767-8502, Monday through Friday, 8:00 AM to 5:00 PM

(Eastern Time). For other areas, contact your local DENTSPLY

representative.

Disposal of Unit

Disposal of unit shall be in accordance with local regulations.

Caution: United States Federal Law restricts this device to sale by or

on the order of, a licensed dental professional.

ENGLISH • 4

• 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,

• applicable industry and governmental agency

recommendations for infection control in dental

healthcare settings,

• requirements and regulations for safe practice of

dentistry, and

• these Directions for Use in their entirety, including

Section 4 Precautions, Section 6 Infection Control, and

Section 10 System Care.

• This product is designed to assist in eliminating susceptibility

to retraction of oral fluids. To ensure adequate protection

from cross-contamination from other devices connected to the

dental unit, it is highly recommended that the dental unit be

installed with anti-retraction features. Additionally, the dental

unit, including the anti-retraction features, must be properly

maintained and periodically tested. For more information,

please contact your dental unit manufacturer.

• Where asepsis is required or deemed appropriate in the best

professional judgment of the dental healthcare professional, this

product should not be used, unless used in combination with a

Sterile Lavage Kit, (P/N 81340).

• During boil-water advisories, this product should not be

operated as an open water system (e.g. connected to a

public water system). Dental healthcare professionals should

discontinue use on patients and contact the local water authority

to determine when it is safe to continue use of this product.

When the advisory is cancelled, the local water authority should

provide guidance for flushing of waterlines. All incoming

waterlines from the public water system inside the dental office

(e.g., faucets, waterlines, and dental equipment) should be

flushed in accordance with manufacturer’s instructions for a

minimum of 5 minutes.

• 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 microorganisms released in the form of

aerosols during treatment.

• The use of high volume saliva evacuation (HVE) to reduce

the quantity of aerosols released during treatment is highly

recommended.

• Failure to follow recommendations for environmental operating

conditions, including input water temperature, could result in

injury to patients or users.

• Handle Cavitron insert with care. Improper handling of insert,

specifically the insert tip, may result in injury and/or cross

contamination.

• Failure to follow properly validated sterilization processes and

approved aseptic techniques for Cavitron inserts may result in

cross contamination.

• DO NOT mount the Cavitron built-in scaler outside of the

dental unit; doing so will void the warranty.

ENGLISH • 5

maintain optimal efficiency and avoid breakage. A DENTSPLY

Professional Insert Wear Indicator is enclosed for your use.

• If excessive wear is noted, or the insert has been bent, reshaped

or otherwise damaged, discard the insert immediately.

• Retract the lips, cheeks, and tongue to prevent contact with the

insert tip whenever it is placed in the patient’s mouth.

• Water should be used for all scaling procedures. Water flow is

adjustable from less than 10 to greater than 60 ml per minute.

• Only adjust the systems’s power adjustment knob with the

insert outside the patients mouth.

• As with all dental procedures, use universal precautions (i.e.,

wear face mask, eyewear, or face shield, gloves, and protective

gown).

Section 5: Adverse Reactions

None known.

Section 4: Precautions

• Equipment flushing and dental water supply system

maintenance are strongly recommended. See Section 10:

System Care.

• Verify handpiece fits properly in the dental delivery system

holder. If not properly seated, there is a potential for the

handpiece to slip out of the holder and be damaged or

contaminated. Contact a service technician for proper fit.

• Close manual shut-off valve on the dental office water supply

every night before leaving the office.

• The use of an in-line water filter is recommended.

• Never operate system without fluid flowing through handpiece.

• Always ensure that the electrical connections on the handpiece

cable and the Steri-Mate Handpiece are clean and dry before

assembling them for use.

• Cavitron ultrasonic scaling units and Cavitron ultrasonic inserts

are designed and tested for safety and efficacy as a system.

Use of any other brand ultrasonic equipment with Cavitron

equipment has not been tested and may have a negative effect

on the safety and effectiveness of your Cavitron equipment and

their warranties. Please review the warranty statement enclosed

before use.

• Like bristles of a toothbrush, ultrasonic insert tips “wear” with

use. Inserts with just 2 mm of wear lose about 50% of their

scaling efficiency. In general, it is recommended that ultrasonic

inserts be discarded and replaced after one year of use to

ENGLISH • 6

Section 6: Infection Control

6.1 General Information

• For operator and patient safety, carefully practice the infection

control procedures detailed in the Infection Control Information

Booklet accompanying your System. Additional booklets can

be obtained by calling Customer Service at 1-800-989-8826,

Monday through Friday, 8 a.m. to 5 p.m. (Eastern Time).

For areas outside the U.S., contact your local DENTSPLY

Professional representative.

• As with high speed handpieces and other dental devices, the

combination of water and ultrasonic vibration from the Cavitron

Built-In Scaler will create aerosols. Following the procedural

guidelines in Section 9 of this manual can effectively control

and minimize aerosol dispersion.

6.2 Water Supply Recommendations

• It is highly recommended that all dental water supply systems

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,

and general infection control procedures (See Sections 7 and

10). Knowledge of and compliance with agency guidelines,

standards, and recommendations is the sole responsibility of the

dental healthcare professional.

• As medical devices, Cavitron products need to be installed

in accordance with local or national regulations, including

guidelines for water quality (e.g. drinking water). As an open

water system, such regulation may require your Cavitron

product to be connected to a centralized water control device

that prevents water contaminates from flowing back into the

water supply.

Section 7: Water Line Requirements

• Incoming water supply line pressure to the ultrasonic scaler

must be 25 psi (172 kPa) minimum to 60 psi (414 kPa)

maximum. If your dental water system's supply line pressure

is above 60 psi, install a water pressure regulator on the water

supply line to your ultrasonic scaler.

• Incoming water temperature to the Cavitron system should not

exceed 25°C (77°F). If needed device should be installed to

maintain a temperature within this specification, or a Cavitron

DualSelect Dispensing System attached to allow this system to

be operated as a closed water system.

• A manual shut-off valve on the dental water system supply line

should be used so that the water can be completely shut-off

when the office is unoccupied.

• A filter in the dental water system supply line is recommended

so that the particles in the water supply will be trapped before

reaching the ultrasonic scaler.

• After the above installations are complete on the dental water

supply system, the dental office water line should be thoroughly

flushed prior to connection to the ultrasonic system.

• After flushing system, verify there are no leaks.

ENGLISH • 7

Section 8: Ultrasonic Scaler System

Description

8.1 System Controls

The DENTSPLY Cavitron Built-In module is enabled whenever the

clinician removes the handpiece from the handpiece holder.

ON/OFF Function

The Ultrasonics is switched ON and OFF using the dental unit foot

control.

Power Adjustment

There are 2 options for adjusting the power to your Cavitron built-in

ultrasonic scaler.

Option 1: Power is adjusted by turning the power

control knob located on the dental unit control that

installed by your service technician. Stickers have

been provided for application to the treatment unit

to denote the Cavitron ultrasonic scaler power range

(see image). These stickers are not required and may or may not

have been applied by your technician. If they have not been applied

or left behind by the technician and you would like to apply them

to your dental unit, contact DENTSPLY Customer Service to order

them.

Option 2: If you are using a treatment unit equipped with a touch

pad, your service technician will wire the power adjustment to the

appropriate buttons on the dental unit. Power can be adjusted using

these buttons.

Lavage Flow Adjustment

Water flow through the handpiece is adjusted by rotating a control

element on the cable connector (blue).

ENGLISH • 8

8.2 Steri-Mate®Handpiece

The Steri-Mate handpiece accepts all Cavitron 30K ultrasonic inserts. The Cavitron Steri-Mate 360 handpiece accepts all Cavitron 30K plastic

grip type ultrasonic inserts. It is not compatible with the Cavitron 30K Slimline metal grip type inserts (30K SLI-10S, SLI-10L and SLI-10R).

Cable Assembly

360 Rotating

Handpiece Nose

Handpiece Connector

(handpiece & mating assembly are keyed)

Steri-Mate 360 Handpiece

Date Codes

Lavage Flow Adjustment

Holding open end of handpiece upright, lavage can be increased

by holding the handpiece and gently twisting the blue lavage

adjustment knob clockwise. The rate of flow through the Handpiece

determines the temperature of the lavage. Low flow rates produce

warmer temperatures, high flow rates produce cooler temperatures.

360 Rotating Handpiece Nose

To rotate the insert, place fingers on the nose of the handpiece and

rotate to desired position. This allows adjustable hand positioning,

free flowing movement, and access within the anterior and posterior

of the oral cavity.

BLUE Lavage Knob

Cable Assembly

360 Rotating

Handpiece Nose

Handpiece Connector

(handpiece & mating assembly are keyed)

Steri-Mate 360 Handpiece

Date Codes

Insert Port

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