Dentsply Sirona Cavitron Select SPS User manual

Cavitron Select®SPS™
Ultrasonic Scaler / Détartreur ultrasonique / Scaler a ultrasuoni / Ultraschall-
Zahnsteinentfernungsgerät / Escarificador ultrasónico / Ультразвуковой аппарат для
удаления зубного камня
Instructions For Use
Mode d'emploi / Istruzioni per l'uso / Gebrauchsanweisung / Instrucciones de uso /
Инструкции по применению
Please read carefully and completely before operating unit.
À lire attentivement et intégralement avant d'utiliser l'appareil. / Si prega di leggere
attentamente e completamente prima di azionare l'unità. / Lesen Sie sich diese
Gebrauchsanweisung vor der Inbetriebnahme des Systems aufmerksam und vollständig
durch. / Lea atentamente todas las instrucciones antes de utilizar la unidad. / Перед
эксплуатацией устройства полностью и внимательно прочитайте инструкцию.
90295 Rev 04/23
Manufactured by:
Dentsply LLC
1301 Smile Way
York, PA 17404 USA
www.dentsplysirona.com
Dentsply DeTrey GmbH
De Trey Strasse 1
Konstanz D-78467
Germany
Cavitron Select®SPS™
Ultrasonic Scaler with Cavitron Select®Reservoir System/ Détartreur ultrasonique
avec système de réservoir Cavitron Select® / Scaler a ultrasuoni con Sistema
Cavitron Select®con serbatoio / Ultraschall-Zahnsteinentfernungsgerät mit Cavitron
Select®-Reservoirsystem / Escarificador ultrasónico con sistema de depósito
Cavitron Select®/ Ультразвуковой аппарат для удаления зубного камня с резервуарной
системой Cavitron Select®

Table of Contents
Introduction 4
Product Overview 4
Technical Support 4
Supplies and Replacement Parts 4
Indications for Use 4
Contraindications 4
Warnings 4-5
Precautions 5
Adverse Reactions 5
Residual Risks 5-6
Infection Control 6
Installation Instructions 7-9
Cavitron Select SPS Ultrasonic Scaler Description 10-12
System Setup, Operation and Techniques for Use 12
System Care 13-14
Troubleshooting 15
Warranty Period 15
Specifications 16
Symbol Identification 17
Classifications 18
Disposal of Unit 18
Electro-Magnetic Compatibility Precautions 18
PAGE BLANK INTENTIONALLY

English - 4 English - 5
Introduction
Dentsply Sirona is an ISO 13485 registered company. All
Dentsply Sirona medical devices sold in Europe are
CE marked in conformance with Council Directive
93/42/EEC.
Caution: United States Federal Law restricts this device to
sale by or on the order of, a licensed dental professional.
For dental use only.
Product Overview
The Cavitron Select®SPS™ Scaling System operates by
converting ordinary AC house current into high frequency
current. the ultrasonic system consists of two parts: an
insert, and the SPS™ (Sustained Performance System)
electronic system. The 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 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.
The Pump/Reservoir accessory for the Cavitron Select®
SPS™ is an optional lavage dispenser. Footswitch plug,
handpiece plug, water tube and power supply plug are
removed from the Scaler before mating with the Pump/
Reservoir. The Scaler is snapped together with the Pump/
Reservoir. The footswitch plug, handpiece plug and power
supply plug are inserted into mating receptacles at the
rear of the Pump/Reservoir. Ultrasonic signal, footswitch
and DC power connections between the units are made
via an edgecard connector at the rear of the Scaler
and the front of the Pump module. The Reservoir has a
capacity of 450 ml. Fluid from the Reservoir is propelled
from the Reservoir Bottle with 15–19 psig compressed air
generated by an internal diaphragm pump. ON/OFF of
the lavage is controlled through an internal solenoid valve.
Fluid to the Handpiece passes directly from the Pump/
Reservoir to the Handpiece. No fluid passes through the
Cavitron Select®SPS™ when used with this accessory.
Flow through any insert in the Handpiece will be greater
than 40 cc/m water when adjusted to maximum.
Technical Support
For technical support and repair assistance in the U.S., call
the Dentsply Sirona Technical Support at 1-800-989-8826,
Monday through Friday, 8:00 A.M. to 5:00 P.M. (Eastern
Time). For other areas, visit www.dentsplysirona.com/eifu
and search "Cavitron Repair Centers" for repair centers or
contact your local Dentsply Sirona representative.
Supplies & Replacement Parts
To order supplies or replacement parts in the U.S., contact
your local Dentsply Sirona Distributor or call 1-800-989-
8826, Monday through Friday, 8:00 A.M. to 5:00 P.M.
(Eastern Time). For other areas, please contact your local
Dentsply Sirona representative.
1: Indications For Use
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.
2: Contraindications
• For best performance, use only ultrasonic inserts
manufactured by Dentsply Sirona.
• Ultrasonic Systems should not be used for restorative
dental procedures involving the condensation of
amalgam.
3: Warnings
• The use of High Volume Evacuation (HVE) to
manage aerosols during the procedure is highly
recommended.
• The effectiveness of pre-procedural rinses has
yet to be fully determined in clinical research.
However, the use of mouth rinses containing:
Chlorhexidine Gluconate, Hydrogen peroxide,
povidone iodine and essential oils, may reduce the
number of microorganisms during aerosol generating
procedures.
• 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 Instructions for Use in their entirety, including
Section 4 Precautions, Section 7 Infection Control,
and Section 11 System Care.
• Where asepsis is required or deemed appropriate
in the best professional judgment of the Dental
Healthcare Professional.
• 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.
• 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 Sirona, we recommend
that the handpiece and cables be kept 6 to 9 inches
(15 to 23 cm) away from any device and their leads
* data on file
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.
• Insufficient water flow could result in elevated
water and tip temperature. When operated at
the input water temperature specified in the
Waterline Requirements Section 8.1 and with
sufficient water flow, the water and tip temperature
should not exceed 50oC (122oF). Failure to follow
recommendations for environmental operating
conditions, including input water temperature, could
result in injury to patients or users. If temperature is
elevated, increase water flow. If temperature remains
elevated, discontinue use.
• During boil-water advisories, this product should not
be operated as an open water system (e.g. connected
to a public water system). A Dental Healthcare
Professional should disconnect the system from
the central water source. The Cavitron DualSelect
system can be attached to this unit and operated
as a closed system until the advisory is cancelled.
When the advisory is cancelled, flush all incoming
waterlines from the public water system (e.g. faucets,
waterlines and dental equipment) in accordance with
the manufacturer’s instructions for a minimum of 5
minutes.
4: Precautions
4.1 System Precautions
• Close manual shut-off valve on the dental office water
supply every night before leaving the office.
• Do not place the system on or next to a radiator or
other heat source. Excessive heat may damage the
system’s electronics. Place the system where air is free
to circulate on all sides and beneath it.
• The system is portable, but must be handled with care
when moving.
• Equipment flushing and dental water supply system
maintenance are strongly recommended. See Section
11: System Care.
• Never operate system without fluid flowing through
the 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
General
• As with all dental procedures, use standard
precautions (i.e., utilize appropriate personal
protective equipment such as mask, protective
eyewear or face shield, protective gown and gloves).
• The power supply shipped with this unit is
• approved for use with devices and must be used to
operate this system.
Ultrasonics
• The Cavitron Select SPS unit works with Cavitron
inserts as a system, and was designed and tested to
deliver maximum performance for all currently available
Cavitron 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 insert before using in a clinical setting.
• Like bristles of a toothbrush, ultrasonic inserts “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.
• 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.
Reservoir System
• Do not place the System on or next to a radiator or
other heat source. Excessive heat may damage the
System’s electronics. Place the System where air is free
to circulate on all sides and beneath it.
• The System is portable, but must be handled with care
when moving.
• Pour liquid into the cap opening of the reservoir bottle.
To prevent potential leaking at the cap, do not overfill
bottle with liquid into the neck of the bottle. Ensure cap
is tightly sealed.
• Turn unit off before refilling reservoir bottle to prevent
potential leaking of fluid. Turn cap a 1/4 revolution
to release air pressure and then remove the cap
completely.
5: Adverse Reactions
None Known.
6: Residual Risks
• Failure to not properly remove water source from
system while no longer in use water damage may occur.
• If unit is not properly assembled and installed in
accordance with these instructions, could cause
potential water damage and/or an overheated
handpiece.
• If the presence of water flow from the insert tip is not
confirmed during operation, an overheated handpiece
may occur.
• The use and maintenance of the water filter is key for
optimum systems operation and will help to prevent
potential safety risks, due to water blockage – causing
overheated handpiece.

English - 6 English - 7
• Failure to follow the validated reprocessing
instructions provided may result in exposing
the patient to cytotoxic residuals and/or cross
contamination.
• Air in handpiece may cause decreased stroke.
• The frequency and decibel levels of sound emitted
by the device may impact individuals with auditory
sensitivity due to underlying conditions which may
include (but are not limited to) vestibular disorders.
7: Infection Control
7.1 General Infection Control
• For operator and patient safety, follow the infection
control procedures detailed in the Infection Control
Information Booklet accompanying your System.
• Dental devices that connect to air and waterlines,
such as high speed handpieces, ultrasonic scalers,
3-way air/water syringe and air polishing units
generate aerosols. Follow the procedural guidelines
in Section 10 of this manual to minimize aerosol
dispersion.
• The objective of the following information is to
supplement published general guidelines for reducing
the potential for cross contamination when using
a Cavitron Select SPS System, Cavitron sterilizable
handpieces or reservoir bottles during routine dental
care. In the event any regulatory agency disagrees
with this information, the agency requirements take
precedence.
• For Infection Control Procedures relating to Cavitron
ultrasonic inserts, refer to the procedures provided
with each instrument.
7.2 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,
chemical flushing, and general infection control
procedures. See Sections 8.1 and 11.
• As a medical device, this product must be installed
in accordance with applicable local, regional, and
national regulations, including guidelines for water
quality (e.g. drinking water). As an open water
system, such regulation may require this device to be
connected to a centralized water control device. The
Cavitron®Select Reservoir System may be installed to
allow this unit to operate as a closed water system.
Cavitron Select SPS Ultrasonic Scaler
Cavitron Select SPS Ultrasonic Scaler with
Cavitron Select Reservoir System
8.1 Waterline Requirements • A water supply line with user-replaceable filter is supplied with your system. See Section 11
System Care for replacement instructions.
• Incoming water supply line pressure to the system must be 20 psi (138 kPa) to 40 psi (275
kPa). If your dental water system’s supply line pressure is above 40 psi, install a water pres-
sure regulator on the water supply line to your Cavitron Select SPS Ultrasonic Scaler.
• 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.
• In addition to the water filter supplied, it is recommended that a filter in the dental water
system supply line be installed so that any particulates in the water supply will be trapped
before reaching the Cavitron Select SPS Ultrasonic Scaler.
• After the above installations are completed on the dental water supply system, the dental
office waterline should be thoroughly flushed prior to connection to the Cavitron Select SPS
Ultrasonic Scaler.
• Incoming water temperature to the Cavitron Select SPS Ultrasonic Scaler should not exceed
25˚C (77˚F). If needed a device should be installed to maintain a temperature within this
specification, or a Cavitron Select Reservoir System attached to allow this system to be
operated as a closed water system.
8.2 Electrical Requirements • Incoming power to the system must be 100 volts AC to 240 volts AC, single phase 50/60 Hz
capable of supplying 1.0 amps.
• The system power should be supplied through the AC power cord provided with your sys-
tem.
• WARNING: To avoid risk of electric shock, this equipment must only be connected to a sup-
ply mains with protective earth.
8.3 Unpacking the System Carefully unpack your unit and verify that all
components and accessories are included:
1. Cavitron Select SPS Scaler.
2. Detachable AC Power Cord set.
3. Steri-Mate Detachable Sterilizable Hand-
piece.
4. Steri-Mate Flow Control Detachable
Handpiece Cable Assembly with Swivel.
5. Dual Position Foot Control Assembly.
6. Hose / Filter / Quick Disconnect Assem-
bly.
7. Additional Waterline Filter.
8. Additional Pump Lavage Filters.
9. Medically Approved Power Supply.
10. Literature Packet.
11. Cavitron Ultrasonic Insert (quantity op-
tional)
Carefully unpack your unit and verify that all
components and accessories are included:
1. Cavitron Select SPS Scaler.
2. Cavitron Select Reservoir Pump.
3. Cavitron Select Reservoir Bottle.
4. Detachable AC Power Cord set.
5. Steri-Mate Detachable Sterilizable Hand-
piece.
6. Steri-Mate Flow Control Detachable
Handpiece Cable Assembly with Swivel.
7. Dual Position Foot Control Assembly.
8. Hose / Filter / Quick Disconnect Assem-
bly.
9. Additional Waterline Filter.
10. Additional Pump Lavage Filters.
11. Medically Approved Power Supply.
12. Literature Packet.
13. Cavitron Ultrasonic Insert (quantity op-
tional).
8.4 System Installation • The Cavitron Select SPS Ultrasonic Scaler is designed to rest on a level surface. Be sure unit
is stable and resting on four feet.
• The Cavitron Select SPS Ultrasonic Scaler should not be positioned such that access to the
power input and AC power cord are limited.
• Placing unit in direct sunlight may discolor plastic housing.
8: Installation Instructions
Anyone installing a Cavitron Select SPS Ultrasonic Scaler should observe the following requirements and recommendations.

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8.6 Power Cord Connection • Verify the Power Control knob is set to the
OFF position before proceeding.
• Plug the detachable AC cord into the back
of the Medically Approved Power Supply.
• Plug the power supply outlet into the back
of the System.
• Plug the 3 prong grounded plug into an
approved outlet
• Verify the Power Control knob is set to the
OFF position before proceeding.
• Plug the detachable AC cord into the back
of the Medically Approved Power Supply.
• Plug the power supply outlet into the back
of the Cavitron Select Reservoir Pump.
8.7 Water Supply Line
Connection
• Grasp the Water Supply Line (blue hose)
by the end opposite the quick-disconnect
and insert it into the water inlet connector
until fully seated.
• Connect the quick-disconnect to the
dental office water supply or a Cavitron
DualSelect Dispensing System.
• Inspect all connections to make certain
there are no leaks.
• To remove the waterline from the Cavit-
ron Select SPS System, turn off the dental
office water supply. Disconnect the water
supply line from the dental office water
supply. If a quick-disconnect connector is
attached to the end of the hose, relieve the
water pressure by pressing the tip of the
connector in an appropriate container and
allow water to drain. To remove the hose
from the system, push on the outer ring of
the system’s water inlet and gently pull out
the waterline.
Not applicable
8.8 Foot Control Cable
Assembly Connection
Align the Foot Control plug with the recep-
tacle on the back of the System and push it
in until firmly seated.
Align the Foot Control plug with the re-
ceptacle on the back of the Cavitron Select
Reservoir Pump and push it in until firmly
seated.
8.9 Lavage Control
Detachable Handpiece
Assembly Connection
• Plug the Handpiece outlet into the recep-
tacle on the back of the System.
• Holding the Handpiece Cable Assembly
seat male connector into appropriate fe-
male connector.
• Once seated, snap male connector into
female connector by pushing on the end of
the male connector.
• Rotate Lavage Control on the handpiece to
middle setting.
• Turn on the on/off switch (power adjust-
ment).
• Plug the Handpiece outlet into the recep-
tacle on the back of the Cavitron Select
Reservoir Pump.
• Holding the Handpiece Cable Assembly
seat male connector into appropriate fe-
male connector.
• Once seated, snap male connector into
female connector by pushing on the end of
the male connector.
• Rotate Lavage Control on the handpiece to
middle setting. Turn on the on/off switch
(power adjustment). This energizes the
system and the ultrasonic unit is ready for
operation.
8.5 System Assembly for
Cavitron Select SPS
Ultrasonic Scaler with
Cavitron Select Reservoir
System
• Remove protective sticker from edge card
connector on the scaler.
• Rinse Cavitron Select Reservoir Bottle
before using.
• Insert Cavitron Select Reservoir Bottle into
Cavitron Select Reservoir Pump and rotate
clockwise until bottle locks into place.
• Connect Cavitron Select SPS Scaler to Ca-
vitron Select Reservoir System. Insert male
edge card connector on Cavitron Select
Reservoir Pump into Cavitron SPS Select
Scaler opening on the back of the Cavitron
Select SPS Scaler. Press down on the top
of the Cavitron Select SPS Scaler (directly
above power setting knob) until the black
striker knob located on the Reservoir
Bottle locks into place.
• To detach Cavitron Select SPS Scaler from
Cavitron Select Reservoir Pump and Bottle,
lift up on the front of the Cavitron Select
SPS Scaler (below power setting knob
and Power/Boost light). After the striker
knob is unsnapped, pull the Cavitron Select
SPS Scaler away from the Cavitron Select
Reservoir Pump.
NOTE: Always disengage striker knob before
pulling the Cavitron Select SPS Scaler away
from the Cavitron Select Reservoir Pump.