ROLENCE ENTERPRISE ELiTEDENT MS-10B User manual

S-19-01-1211-U0001 V4.3
ROLENCE ULTRASONIC SCALER
ELiTEDENT
®
MS-10B
(Built-in type)
ROLENCE ENTERPRISE INC.
No. 18-3, Lane 231, Pu Chung Rd., Chungli, Taoyuan 32083, Tai an
TEL: [phone] .rolence.com.t
User Manual

2 S-19-01-1211-U0001 V4.3
Table Of Contents
Section Section Title Page
Number Description of Contents
1Precautions……………………………………………………………………………………..
1.1 Precautions for All Systems
1.2 Precautions for Ultrasonic Prophylaxis Procedure
2Introduction…………………………………………………………………………………....4
Application………………………………………………………………………………………4
4Specification…………………………………………………………………………………...4
5Contraindications and Warnings…………………………………………………………5
5.1 Contraindications
5.2 Warnings
6Infection Control………………………………………………………………..…………….5
6.1 General Infection Control Recommendations
6.2 Water Supply Recommendations
7Installation Instructions…………………………………………………………………6-8
7.1 General Information
7.2 Water Line Requirements
7. Electrical Requirements
7.4 Unpacking the System
7.5 System Installation
8ELiTEDENT
®
Ultrasonic Scaler Description……………………………………………8
8.1 Handpiece Assembly/ Handpiece Sleeve
9Techniques For Use…………………………………………………………..………………9
9.1 Patient Positioning
9.2 Performing Ultrasonic Scaling Procedures
9. Patient Comfort Considerations
10 System Maintenance And Care………………………………………..………………10
11 Trouble shooting………………………………………………………….…………………11
12 Disposable of Unit…………………………………………………….…………………….11
1 Disclaimer………………………………………………………………….………………….11
14 WARRANTY……………………….…………………………………………….…………….11
15 Additional Symbols…………………….…………………………………………………..12

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Section 1: Safety Precautions
Prior to installation and start-up of the ultrasonic scaler, carefully read the instructions provided herein!
1.1 Precautions for All Systems
Do not place the ultrasonic scaler on or next to a radiator or other heat source. Excessive heat may
damage the ultrasonic scaler’s electronics.
Equipment and dental ater supply system maintenance are strongly recommended. See Section 10:
System Maintenance And Care.
Close the ater shut-off valve in the dental ater supply system every night before leaving the office.
The use of an in-line ater filter is recommended.
Used for the intended purpose only. The ultrasonic scaler must be used by other than qualified and
trained personnel, in medical facilities.
Grounding reliability can only be achieved hen the equipment is connected to an equivalent
receptacle marked Hospital Only or Hospital Grade.
1.2 Precautions for Ultrasonic Prophylaxis Procedures
‧ Before first use, clean, disinfect and sterilize ne or repaired handpieces and instruments you ish to use
ith the ultrasonic scaler.
‧ Al ays examine the unit and ultrasonic tips before commencing treatment. A damaged ultrasonic scaler
or damaged tip must not be used.
‧ Ultrasonic 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 ith the ultrasonic tip henever it is placed in the
patient's mouth.

4 S-19-01-1211-U0001 V4.3
Section 2: Introduction
Rolence Enterprise Inc. is an ISO 9001(2008), ISO
13485(2003) certified manufacturer of Ultrasonic
Scalers. All the products are FDA registered and
compliant ith EN standard (CE Marking).
2.1 Conformance to Standards:
The Rolence
®
ELiTEDENT
®
MS-10B Ultrasonic Scaler
conforms to IEC60601-1-2:2001 and
IEC60601-1-1:2000. (Refer to Appendix I)
The device is CE marked corresponding to European
Medical Device Directive (9 /42/EEC)
2.2 Function
The ultrasonic scaler is designed for use in
prophylaxis treatments periodontia, and other areas
of operative dentistry. When used in prophylaxis
treatment, the unit operates ith a fine arm ater
spray, requiring little of the physical exertion
necessary ith hand instruments. It easily and
effectively removes stubborn calculus and stains
both supragingivally and subgingivally, leaving
cro n and root surfaces clean and smooth.
2. Supplies and Replacement Parts
Contact your local Rolence dealer to order supplies
or replacement parts. There are no serviceable parts
included in this device. Please contact your dealer to
acquire all repairing service and technique supports.
CAUTION: EQUIPMENT NOT SUITABLE FOR
USE IN THE PRESENCE OF FLAMMABLE
ANESTHETIC MIXTURE WITH AIR OR WITH
NITROUS OXIDE.
CAUTION: U.S FEDERAL LAW RESTRICTS THIS
DEVICE TO SALE BY OR ON THE ORDER OF A
DENTAL PROFESSIONAL.
Section : Application
The Ultrasonic Scaler procedures
‧ All general supra and subgingival scaling applications.
‧ Periodontal treatment for all types of periodontal diseases.
‧ Endodontic procedures, preparation of root canals, etc.

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Section 4: Specifications
Rolence
®
ELiTEDENT
®
MS-10B Ultrasonic Scaler requires 24V AC power supply from dental unit.
4.1 Electric Voltage:
VOLTAGE: CURRENT
24V AC 50/60Hz 4.0A(MAX)
WATTAGE: MAX.60W
WATER PRESSURE: 20-40 psi
4.2 Main Control Unit Dimension:
HEIGHT : 34 mm
WIDTH : 127 mm
DEPTH : 100 mm
WEIGHT : 340 g
4. Operation Environment:
AMBIENT TEMPERATURE
:+10 ℃ ～ +40 ℃
RELATIVE HUMIDITY
:30% ～ 75%
ATOMOSPHERIC PRESSURE
:700 hPa ～ 1060hPa
4.4 Transportation And Storage Environment:
AMBIENT TEMPERATURE
: － 10 ℃～ +70 ℃
RELATIVE HUMIDITY
: 10% ～ 90%
ATOMOSPHERIC PRESSURE
: 500 hPa ～ 1060hPa
Section 5: Contraindications and Warnings
5.1 Contraindications
‧ Ultrasonic systems should not be used for
restorative dental procedures involving the
condensation of amalgam.
‧ This device is designed to ork ith all Cavitron
®
(remark) insert ith 25Khz or 30Khz frequency
automatically. For optimum performance please
use only qualified inserts supplied by Cavitron
®
or
Rolence
®
.
‧ Do not use this device if the patient or operator is
earing a pacemaker.
Remark: Cavitron
®
is a registered trademark of
Dentsply
®
International, Inc.
5.2 Warnings
‧ Persons ho are fitted ith cardiac pacemakers,
defibrillators and other active implanted medical
devices, have been cautioned that some types of
electronic equipment might interfere ith the
operation of the device. We recommend that the
handpiece and tubing be kept at least 6 to 9
inches (15 to 23 cm) a ay from any device and
their leads during use.
‧ During using the unit, make sure that ater is
flo ing continuously. If the handpiece overheats
please check the ater supply, and stop using the
unit for a hile.
Section 6: Infection Control
6.1 General Infection Control
Recommendations
‧ As ith all dental procedures, the use of standard
personal protection equipment (i.e., earing a
face mask, eye ear, or face shield, gloves and
protective go n) is recommended.
‧ For maximal operator and patient safety, carefully
follo section 10 system maintenance and care
information detailed in the operating instruction.
‧ As ith high speed handpieces, and other dental
devices, the combination of ater and ultrasonic
vibration from your ELiTEDENT
®
Ultrasonic Scaler
ill create aerosols. With proper technique, much
of the aerosol dispersion can be effectively
controlled and minimized. Please carefully follo
the procedural guide lines in this manual

6 S-19-01-1211-U0001 V4.3
regarding the use of your ultrasonic scaler.
‧ Al ays flush your ELiTEDENT
®
Ultrasonic Scaler
ith highest flo before treatment. Refer to more
information in section 10.
‧ Clean and disinfect the handpiece sleeve bet een
patients. The handpiece sleeve can be autoclaved
up to 135 ℃ for at least 3 minutes.
Sterilizing:
1. Place handpiece sleeve and pouched ultrasonic
insert into a steam autoclave. After arm-up is
completed, operate at a sterilizing temperature
and pressure of 273° F/31 psi (134°C/216 kPa)
for 12 minutes, follo ed by a 20-30 minute
drying time.
2. To maintain sterility, the insert should remain in
the sealed pouch until it is ready for use.
DO NOT USE Cold sterilization solution.
6.2 Water Supply Recommendations
‧ It is highly recommended that all dental ater
supply systems should conform to applicable CDC
(Centers for Disease Control and Prevention) and
ADA (American Dental Association) standards,
and that all recommendations be follo ed in
terms of flushing, chemical flushing, and general
infection control procedures. See sections 6.1 and
10
Section 7: Installation Instructions
7.1 General Information
If the installation of your ELiTEDENT
®
MS-10B ultrasonic scaler is performed by someone other than
trained Rolence
®
distributor personnel, care should be taken to observe the follo ing requirements and
recommendations.
7.2 Water Line Requirements
‧ Incoming ater supply line pressure to the ultrasonic scaler must be 25 psi (172 kPa minimum) to 40 psi
(276 kPa) maximum. If your dental ater system's supply line pressure is above 60 psi, install a ater
pressure regulator on the ater supply line to your ultrasonic scaler.
‧ A manual shut-off valve on the dental ater system supply line should be used so that the ater can be
completely shut-off hen the office is unoccupied.
‧ A filter in the dental ater system supply line is recommended so that any particles in the ater supply
ill be trapped before reaching the ultrasonic scaler.
7. Electrical Requirements
Refer to Section 3: Specifications.
7.4 Unpacking the System
Carefully unpack your ELiTEDENT
®
ultrasonic scaler and verify that all components and accessories are
included:
1. ELiTEDENT
®
MS-10B Ultrasonic scaler main control unit.
2. Handpiece set ith tubing.
3. Variable Resistor ith knob
4. Users Manuals.
5. Solenoid and mounting bracket ( Optional )

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7.5 Installation Instruction of MS-10B
1. The main control unit should be fixed inside the dental unit here is free from ater.
2. Connect handpiece ater supply tube to the ater control valve in the dental unit.
3. Follo ing belo pin definition for the ire connection to set up the system.
4. 24V, 3A AC po er is required for this system.
5. Please connect the dental unit holder s itch and po er input of this system ( Pin 1 & 2 ) in series
connection.
Terminal Block
10- pin
10
9
8
7
6
5
4
3
2
1
Pin#
1 2 3 4 5 6 7 8 910
Pin Definition
1,2 - 24V AC, 3A
3,4 - Open or Solenoid, if solenoid is applied, be sure to
use Rolence’s solenoid(optional).
5,6 - Switch, Short circuit is ON, It could be Foot Padel Switch
or other switch.
7,8 - Variable Resistor, 5KΩ
9,10 - Handpiece Wires
Optional : Solenoid Assembly
If you need Solenoid, the assembly is as below, be sure to use the solenoid from
Rolence.

8 S-19-01-1211-U0001 V4.3
M4 Screw
M3 Screw
Important Notice:
1.This built-in scaling system is equipped ith microprocessor hich could be interfered and
malfunctioned by outer electromagnetic noise. Most motors of dental units produce large number of
electromagnetic noise hile operating, such noise could result in the scaler out of order. In order to
prevent the built-in scaler from shutting do n (mostly kno n as fail to detect and lock orking frequency
correctly), the handpiece should be hang back to the holder here should function a safety s itch to cut
off the 24V AC po er supply.
2.Unkno n /uncertified scaling inserts may easily cause extra heat on handpiece hen in operation, due
to improper materials or imprecise tip dimension. To ensure safe and guaranteed practice, only certified
Cavitron® and Rolence inserts are recommended to be used.
3.Please note that po er supply AC 24V, 3A is required for this system. If the po er supply current is less
than 3 Ampere, it may lead the handpiece ork at eak vibration.
4.Make sure the Handpiece orking ith continuous ater irrigation spray during operation. Do not run
the system ithout ater. The Handpiece ould overheat easily ith risk of plastic Handpiece melting.
Section 8: ELiTEDENT
®
Ultrasonic Scaler Description
8.1 Handpiece Assembly / Handpiece Sleeve
The ultrasonic scaler is multi-frequency unit compatible ith all Cavitron
®
25Khz or 30 Khz inserts. The
system ill automatically detect the insert frequency, no need to s itch any button.
For more oral hygiene care, the handpiece sleeve can be dismantled and autoclaved. See belo :

9 S-19-01-1211-U0001 V4.3
To take off the handpiece sleeve, please hold the fastening ring, and rotate the sleeve counterclock ise
from handpiece tubing assembly. Note: Avoid rotate or twist the handpiece tubing.
Section 9: Techniques For Use
9.1 Patient Positioning
‧ For optimal access to both the upper and lo er
arches, the backrest of the chair should be
adjusted to a 45 ∘ degree angle. This assures
patient comfort and Clinician visibility.
‧ Have the patient turn his/her head to the right or
left. Also position chin up or do n depending
upon the quadrant and surface being treated.
Evacuate irrigate using either a saliva ejector or
High Volume Evacuator (HVE).
9.2 Performing Ultrasonic Scaling Procedures
‧ Note: Refer to the Section 6 and 11 for general
procedures to be follo ed at the beginning of
each day and bet een patients.
‧ The edges of ultrasonic inserts are intentionally
rounded so there is little danger of tissue
laceration ith proper ultrasonic Scaling
technique. Whenever the insert tip is placed in the
patient’s Mouth, the lips, cheek and tongue
should be retracted to prevent Accidental
prolonged contact ith the activated tip.
‧ Hold the empty handpiece in an upright position.
Activate the Foot Control until fluid exits.
‧ Lubricate the rubber O-ring on the insert ith
ater before placing it into the handpiece. Fully
seat insert ith a gentle push-t ist motion. DO
NOT FORCE IT INTO PLACE.
‧ Activate the System. Hold the handpiece over a
sink or drain. Check spray temperature to verify
fluid is reaching the orking end of the insert tip.
Adjust the ater cooler irrigate. Control knob to
ensure adequate flo for the selected Po er
setting. Greater flo settings provide cooler
irrigation.
‧ It may be necessary to adjust ater flo larger
under "Turbo" mode (Foot Control fully depressed)
so adequate fluid ill be available to cool tip and
tooth interface.
‧ In general, it is suggested a "feather-light-touch"
be used both supra and subgingivally. The motion
of the activated tip and acoustic effects of the
irrigating fluid, in most cases, is adequate to
remove even the most tenacious calculus.
Handpiece Sleeve
Enable to dismantle
and autoclave
Fastening Ring
Hold here, rotate handpiece
sleeve to release.
Handpiece tubing assembly
Include handpiece set, tubing
and fastening ring.
O-ring

10 S-19-01-1211-U0001 V4.3
‧ Periodically check the ultrasonic insert for ear
ith the Insert Efficiency Indicator.
‧ The use of a saliva ejector or High Volume
Evacuator (HVE) is recommended during all
procedures.
‧ Set the System's Po er Adjustment knob to the
lo est po er setting for the application and the
selected insert.
‧ If ater leakage found in handpiece, replace
sleeve or o-ring on handpiece cable assembly to
eliminate.
9. Patient Comfort Considerations
Reasons for sensitivity
‧ Incorrect tip placement. Point should be directed
a ay from root surfaces.
‧ Not keeping tip in motion on tooth. Do not allo
the insert to remain in a static position on any one
area of the tooth. Change the insert's path of
motion.
‧ Applying pressure. Use extremely light grasp and
pressure, especially on exposed cementum.
‧ If sensitivity persists, decrease po er setting
and/or move from the sensitive tooth to another
and then return.
Section 10: System Maintenance and Care
Daily Maintenance
It is recommended that you perform the follo ing
maintenance procedures to help minimize bio-film
formation in the ater path of your ELiTEDENT
®
ultrasonic scaler hich could affect the ater flo to
the ultrasonic insert, and scaling performance.
Start-Up Procedures at the beginning of the
day:
1. Open the manual shut-off valve on the dental
office ater supply system.
2. Set the Po er Control knob to minimum setting.
3. Set the Water Control knob to maximum.
4. Hold the Handpiece ( ithout an insert installed)
upright over a sink or drain. Activate the Foot
Control and flush the ater line for at least 2
minutes.
5. Place a sterilized insert into the Handpiece and
set the ater control knob to your preferred
operating position.
Between Patients:
1. Remove ultrasonic insert and handpiece sleeve
used, clean and sterilize.
2. Clean and disinfect the surfaces of the cabinet,
Handpiece cable assembly*, control knobs by
applying an approved non-immersion type
disinfectant solution* carefully follo ing the
instructions provided by the disinfectant solution
manufacturer. To clean system, generously spray
disinfectant solution on a clean to el and ipe all
surfaces. Discard used to el. To disinfect system,
generously spray disinfectant on a clean to el
and ipe all surfaces. Allo disinfectant solution
to air dry. Do not spray disinfectant solution
directly on the ultrasonic scaler.
3. Place a sterilized handpiece sleeve. Set po er to
minimum. Hold the handpiece over a sink or drain
and flush the ater line at maximum ater flo
for 30 seconds.
4. When ready, place a sterilized insert into the
handpiece.
5. Please consider use a FDA approved sheath to for
the cable and entire handpiece or at least to cover
the handpiece from the fastening ring to cable
hen sleeve is sterilized bet een patients.
Shut-Down Procedures at the end of the day:
1. Remove ultrasonic insert and handpiece sleeve
used, clean and sterilize.

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2. Turn the System OFF.
3. Clean and disinfect the surfaces of the cabinet,
Handpiece cable assembly, control knobs, Foot
Control by applying an approved non-immersion
type disinfectant solution* carefully follo ing the
instructions provided by the disinfectant solution
manufacturer. To clean system, generously spray
disinfectant solution on a dean to el and ipe all
surfaces. Discard used to el. To disinfect system,
4. generously spray disinfectant on a clean to el
and ipe all surfaces. Allo disinfectant solution
to air dry. Do not spray disinfectant solution
directly on the ultrasonic scaler.
5. Close the manual shut-off valve on the dental
ater supply system.
*Note: Those Water-based disinfection solutions
are preferred, due some alcohol-based disinfectant
solutions may be harmful and may discolor plastic
materials.
*Note: The electric ire inding covered by heat
shrinkage tube hich protected by handpiece sleeve
is very sensitive to the disinfectant solution and
ater. After the disinfection, ipe surface of
shrinkage tube ith a slightly damp cloth and dry
thoroughly before use.
Section 11: Trouble shooting
Although service and repair of the ELiTEDENT
®
Ultrasonic Scaler should be performed by ROLENCE
dealer personnel, the follo ing are some basic
trouble shooting procedures that ill help avoid
unnecessary service calls. Generally, check all lines
and connections to and from the System, a loose
plug or connection ill often create problems. Check
the settings on the System's knobs.
Problem: Insert stops vibrating
1. Deactivate foot control.
2. Verify insert is in good condition.
3. Depress foot control to try again.
Section 12: Disposal of Unit
Dispose of the ELiTEDENT
®
Ultrasonic Scaler in accordance ith local and national la s.
Section 1 : Disclaimer
ROLENCE Enterprise Inc. considers itself responsible for the effects on safety, reliability and performance
of this product only if:
‧ Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons
authorized by ROLENCE.
‧ The electrical installation of the relevant room complies ith the requirements.
‧ The equipment is used in accordance ith these instructions for use.
Section 14: Warranty
15.1 Malfunction
Rolence hereby arrants that for a period of one year from the delivery date, this device shall be free from

12
S-19-01-1211-U0001 V4.3
defects in material and orkmanship. In case the machine is found malfunctioned under normal use,
Rolence ill offer service of free maintenance and parts for replacement.
15.2 Repair
Repairs must be only carried out by an authorized Rolence engineer/dealer. If repairs during arranty
period are not carried out by an authorized engineer/dealer, arranty ill expire immediately.
15. Warranty Exception
The arranty stated herein is the sole arranty applicable to Rolence products. Rolence expressly
disclaims the liability for arranty even ithin arranty period, if
(1) Damages caused by natural disaster.
(2) Operator's fault or rong operation.
(3) Application use other than curing light-cured material purpose.
(4) A malfunction or damage caused by repair, adjustment, modification hich is not carried out by
Rolence authorized technicians/dealers.
(5) A malfunction caused by abnormal po er source or voltage.
(6) It is a consumption part.
Section15: Additional Symbols
BF Type.
Attention, refer to accompanying documents.
Power off
Power on
14 4
The equipment complies with the requirements in the Medical Device Directive 9 /42 EEC.
EU authorized representative name and address
CMC Medical Devices & Drugs S.L.
C/ Horacio Lengo n18, C.P 29006, Málaga-Spain
Rolence Enterprise Inc.
No. 18-3, Lane 231, Pu Chung Rd.,
Chungli, Taoyuan 32083, Tai an