DENTSPLY Cavitron SPS G98A Manual

Ultrasonic Scaler
with Cavitron®Steri-Mate®Handpiece
Détartreur à ultra-sons
avec pièce à main Cavitron® Steri-Mate®
Escarificador ultrasónico
con irrigador bucal Cavitron®Steri-Mate®
Ultraschall-Zahnsteinentfernungsgerät
mit Cavitron®Steri-Mate®-Handstück
Ablatore a ultrasuoni
con manipolo Cavitron®Steri-Mate®
Ультразвуковой аппарат
для удаления зубного камня с
наконечником Cavitron®Steri-Mate®
Directions For Use
Mode d’emploi
Instrucciones para el uso
Gebrauchsanweisung
Istruzioni per l’uso
Указания по применению
Cavitron®SPS™G98A

ENGLISH • 1
Introduction
DENTSPLY Professional is an ISO 13485 registered company.
The DENTSPLY Cavitron®SPS™Scaler System is classified by
Underwriters Laboratories Inc. with respect to electric shock, fire,
and mechanical hazards in accordance with UL 60601-1 and CSA
C22.2 no. 601.1.
The Cavitron SPS 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®SPS™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 exceptional
operator and patient comfort.
ENGLISH
Cavitron®SPS™Ultrasonic Scaler
with Cavitron®Steri-Mate®Handpiece
Model G98A
Directions For Use
Please read carefully and completely before operating unit.

ENGLISH • 2
1. Indications.....................................................................................................................3
1.1 Ultrasonic procedures
2. Contraindications .........................................................................................................3
3. Warnings .......................................................................................................................3–4
4. Precautions....................................................................................................................5
4.1 System Precautions
4.2 Procedural Precautions
5. Infection Control...........................................................................................................6
5.1 General Information
5.2 Water Supply Recommendations
6. Installation Instructions.................................................................................................7–8
6.1 Installation
6.2 Water Line Requirements
7. SPS™ Ultrasonic Scaler System Description ..............................................................9–12
7.1 System Controls
7.2 Steri-Mate®Handpiece
7.3 Cavitron® 30K™Ultrasonic Inserts
7.4 Foot Control Information & Operation
8. Accessories ...................................................................................................................12
9. Techniques for Use .......................................................................................................12–13
9.1 Patient Positioning
9.2 Performing Ultrasonic Scaling Procedures
9.3 Patient Comfort Considerations
10. System Care ..................................................................................................................13–14
10.1 Daily Protocol
11. Troubleshooting ............................................................................................................15–19
12. Warranty........................................................................................................................20
13. Specifications................................................................................................................20
14. Classifications...............................................................................................................20
Section Section Title/Description of Contents Page Number
Table of Contents

ENGLISH • 3
Section 1: Indications
1.1 Ultrasonic procedures
The Dentsply® Cavitron® SPS Scaler System is designed for
use in general prophylaxis and periodontal treatments and other
areas of operative dentistry. It is used to debride light to heavy
calculus and plaque deposits from tooth and root surfaces.
Section 2: Contraindications
2.1 Contraindications
• Ultrasonic Systems should not be used for restorative
procedures involving condensation of amalgam.
Section 3: Warnings
3.1 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.
Intended Use
This product is intended for installation into an existing dental
handpiece delivery system. The end users are dental professionals.
The devices are used to debride light to heavy calculus deposits from
the tooth and root surfaces. Other applications specialties include
Periodontics, Orthodontics, and Endodontics.
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 Professional 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,
• and 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 5
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 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.

ENGLISH • 5
Section 4: Precautions
4.1 System Precautions
• Equipment flushing and dental water supply system
maintenance are strongly recommended. See Section 10:
System Care.
• 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.
4.2 Procedural Precautions
• The Cavitron SPS G98A unit works with Cavitron inserts as
a system, and was designed and tested to deliver maximum
performance for all currently available Cavitron and
Cavitron Bellissima® brand ultrasonic inserts. Companies
that manufacture, repair or modify inserts carry the sole
responsibility for proving the efficacy and performance of
their products when used as a part of this system. Users are
cautioned to understand the operating limits of their inserts
before using in a clinical setting.
• 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 maintain optimal efficiency and avoid breakage. A
DENTSPLY Professional Insert Efficiency 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.
• Ultrasonic insert tips that have been bent, damaged, or reshaped
are susceptible to in-use breakage and should be discarded and
replaced 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 system's power adjustments knob with the insert
outside the patients mouth.

ENGLISH • 6
Section 5: Infection Control
5.1 General Information
• As with all dental procedures, use universal precautions (i.e., wear
face mask, eyewear, or face shield, gloves, and protective gown).
• 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, 8:00 A.M. to 5:00
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 SPS Scaler will create aerosols. Following
the procedural guidelines in Section 9 of this manual can
effectively control and minimize aerosol dispersion.
5.2 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 6.2 and 10)
Knowledge of and compliance with agency guidelines, standards
and recommendations is the sole responsibility of the Dental
Healthcare Professional.
• As a medical device, 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 containing contaminates from back-flow
into the water supply.

ENGLISH • 7
Section 6: Installation Instructions
6.1 Installation
Your Cavitron®SPS™has been installed by trained technicians. The diagram below shows all connections
to your dental treatment unit. The power source must be double insulated type SELV device and qualified to IEC 601.1

ENGLISH • 8
6.2 Water Line Requirements
• Incoming water supply line pressure to the ultrasonic scaler
must be 25 psi (172kPa) 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.