ROLENCE ENTERPRISE ELiTEDENT MS-30 User manual

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S-19-01-1218-U0001 V1.5
ROLENCE® ELiTEDENT®
ULTRASONIC SCALER
MS-30
ROLENCE ENTERPRISE INC.
No. 18-3, Lane 231, Pu Chung Rd., Chungli, Taoyuan 32083, Taiwan
TEL: [phone] FAX: [phone] www.rolence.com.tw
User Manual

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S-19-01-1218-U0001 V 1.5
Table Of Contents
Section Section Title Page
Number Description of Contents
1Precautions……………………………………………………………………………………………..3
1.1 Precautions for All Systems
1.2 Precautions for Ultrasonic Prop ylaxis Procedure
2Introduction…………………………………………………………………………………………....4
3Glossary of Symbols…………………………………………………………………………….......4
4Intended Use……………………………………………………………………………………………5
5Specification………………………………………….………………………………………………...5
6Contraindications and Warnings…………………………………………………………………5
6.1 Contraindications
6.2 Warnings
7Infection Control……………………………………………………………………………………….6
7.1 Function
7.2 General Infection Control Recommendations
7.3 Water Supply Recommendations
8Installation Instructions……………………………………………………………………………7
8.1 General Information
8.2 Water Line Requirements
8.3 Electrical Requirements
8.4 Unpacking t e System
8.5 System Installation
8.6 Power Connection
8.7 Water Supply Line Connection
9ELiTEDENT
®
Ultrasonic Scaler Description……………………………………………………8-9
9.1 Rear Panel
9.2 System Controls
9.3 Handpiece Assembly/ Handpiece Sleeve
9.4 Foot Switc Controls and Operation
10 Accessories………………………………………………………………………………………………9
11 Tec niques For Use……………………………………………………………………………………10
11.1 Patient Positioning
11.2 Performing Ultrasonic Scaling Procedures
11.3 Patient Comfort Considerations
12 System Maintenance And Care………………………………………………………………….11
13 Trouble s ooting……………………………………………………………………………………..12
14 Disposable of Unit…………………………………………………………………………………...12

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15 Disclaimer……………………………………………………………………………………………...12
16 WARRANTY………………………………….………………………………………………………...13
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. Place the ultrasonic scaler where air is free to circulate on all sides
and eneath it. Do not cover vents on rear panel.
The ultrasonic scaler is porta le, ut must e handled with care when moving.
Equipment and dental water supply system maintenance are strongly recommended. See Section 12:
System Maintenance And Care.
Close the water shut-off valve in the dental water supply system every night efore leaving the office.
The use of an in-line water filter is recommended.
Used for the intended purpose only. The ultrasonic scaler must e used y other than qualified and
trained personnel, in medical facilities.
Grounding relia ility can only e achieved when the equipment is connected to an equivalent receptacle
marked Hospital Only or Hospital Grade.
1.2 Precautions for Ultrasonic Prop ylaxis Procedures
‧ Before first use, clean, disinfect and sterilize new or repaired handpieces and instruments you wish to use
with the ultrasonic scaler.
‧ Always examine the unit and ultrasonic tips efore commencing treatment. A damaged ultrasonic scaler
or damaged tip must not e used.
‧ Ultrasonic tips that have een ent, damaged, or reshaped are suscepti le to in-use reakage and should
e discarded and replaced immediately.

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S-19-01-1218-U0001 V 1.5
Retract the lips, cheeks and tongue to prevent contact with the ultrasonic tip whenever it is placed in the
patient's mouth.
Section 2: Introduction
Rolence Enterprise Inc. is an ISO 13485 certified
manufacturer of Ultrasonic Scalers. All the products
are FDA registered and compliant with EN standard
(CE Marking).
2.1 Conformance to Standards:
The Rolence
®
ELiTEDENT
®
MS-30 Ultrasonic Scaler
conforms to IEC60601-1-2:2007 and
IEC60601-1-1:2006.
The device is CE marked corresponding to European
Medical Device Directive (93/42/EEC)
2.2 Supplies and Replacement Parts
Contact your local Rolence dealer to order supplies
or replacement parts. There are no servicea le 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 3: Glossary of Symbols
Attention, Consult accompanying Documents
Alternating Current
Power off
Power on
Manufacturer
Date of manufacture
Catalogue number
Type BF Applied Part; Type BF Equipment - Protection against electric
s ock
Equipment class: Class II (IEC601-1) - double insulated

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S-19-01-1218-U0001 V 1.5
1434
T e equipment complies wit t e requirements in t e Medical Device
Directive 93/42 EEC.
Icon to identify electric and electronic devices. T e unit must be
collected and disposed of separately.
Section 4: Intended Use
Ultrasonic procedure
‧ All general supra and su gingival scaling applications.
‧ Periodontal de ridement for all types of periodontal diseases.
Section 5: S ecification
Rolence
®
ELiTEDENT
®
MS-30 Ultrasonic Scaler
Voltage input: 100V, 110V, 230V, 240V
5.1 Electric Voltage:
VOLTAGE: CURRENT
100VAC 50/60Hz 0.9A (MAX)
110VAC 50/60Hz 0.75A (MAX)
230VAC 50/60Hz 0.4A (MAX)
WATTAGE: MAX.85W
WATER PRESSURE: 20-40 psi
5.2 Dimension:
HEIGHT : 13.5 CM
WIDTH : 20.5 CM
DEPTH : 11.0 CM
WEIGHT : 850g
EXTERNAL POWER WEIGHT 1.2kg
Tip vi ration frequency: 25±3KHz
Half-excursion force: <1N
5.3 Operation Environment:
AMBIENT TEMPERATURE
:+10 ℃ ～ +40 ℃
RELATIVE HUMIDITY
:30% ～ 75%
ATOMOSPHERIC PRESSURE
:700 hPa ～ 1060hPa
5.4 Transportation And Storage Environment:
AMBIENT TEMPERATURE
: － 10 ℃～ +70 ℃
RELATIVE HUMIDITY
: 10% ～ 90%
ATOMOSPHERIC PRESSURE
: 500 hPa ～ 1060hPa
Section 6: Contraindications and Warnings
6.1 Contraindications
‧ Ultrasonic Systems should not e used for
restorative dental procedures involving the
condensation of amalgam.
‧ This device is designed to work with all Cavitron
®
(remark) 25Khz and 30Khz frequency inserts. For
optimum performance please use only qualified
inserts supplied y Cavitron
®
or Rolence
®
.
‧ Do not use this device if the patient or operator is
wearing a pacemaker.
Remark: Cavitron
®
is a registered trademark of
Dentsply
®
International, Inc
6.2 Warnings
‧ Persons who are fitted with cardiac pacemakers,
defi rillators and other active implanted medical
devices, have een cautioned that some types of

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S-19-01-1218-U0001 V 1.5
electronic equipment might interfere with the
operation of the device. We recommend that the
MS handpiece ca le kept at least 6 to 9 inches (15
to 23 cm) away from any device and their leads
during use.
‧ During using the unit, make sure that water is
flowing continuously. If the handpiece overheats
please check the water supply, and stop using the
unit for a while.
Section 7: Infection Control
7.1 Function:
The Elitedent
®
MS-30 Ultrasonic Scaler is designed
for use in prophylaxis treatments periodontia, and
other areas of operative dentistry.
When used in prophylaxis treatment, the unit
operates with a fine water spray, requiring little of
the physical exertion necessary with hand
instruments. It easily and effectively removes
stu orn calculus and stains oth supragingivally
and su gingivally, leaving crown and root surfaces
clean and smooth.
7.2 General Infection Control
Recommendations
‧ As with all dental procedures, the use of standard
personal protection equipment (i.e., wearing a
face mask, eyewear, or face shield, gloves and
protective gown) is recommended.
‧ For maximal operator and patient safety, carefully
follow section 12 system maintenance and care
information detailed in the operating instruction.
‧ As with high speed handpieces, and other dental
devices, the com ination of water and ultrasonic
vi ration from your ELiTEDENT
®
Ultrasonic Scaler
will create aerosols. With proper technique, much
of the aerosol dispersion can e effectively
controlled and minimized. Please carefully follow
the procedural guide lines in this manual
regarding the use of your ultrasonic scaler.
‧ Always flush your ELiTEDENT
®
Ultrasonic Scaler
at least 20 seconds with highest flow after each
treatment. Refer to more information in section
12.
‧ Clean and disinfect the steriliza le sleeve of
handpiece etween patients. The steriliza le
sleeve of handpiece can e autoclaved up to 135
℃ for at least 10 mincutes.
Sterilizing:
1. Autoclave: compliant with standard EN 13060.
2. Place steriliza le sleeve of handpiece and
pouched ultrasonic insert into a steam autoclave.
After warm-up is completed, operate at a
sterilizing temperature and pressure of 273° F/31
psi (134°C/216 kPa) for 18 minutes, followed y a
20-30 minute drying time.
3. To maintain sterility, the insert should remain in
the sealed pouch until it is ready for use.
DO NOT USE Cold sterilization solution.
7.2 Water Supply Recommendations
‧ It is highly recommended that all dental water
supply systems should conform to applica le CDC
(Centers for Disease Control and Prevention) and
ADA (American Dental Association) standards,
and that all recommendations e followed in
terms of flushing, chemical flushing, and general
infection control procedures. See sections 7.2 and
12.

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S-19-01-1218-U0001 V1.5
Section 8: Installation Instructions
8.1 General Information
If the installation of your ELiTEDENT
®
MS-30
ultrasonic scaler is performed y someone other
than trained Rolence
®
distri utor personnel, care
should e taken to o serve the following
requirements and recommendations.
8.2 Water Line Requirements
‧ The system's pu lic water supply tu e is factory
provided. Do not discard it from the ultrasonic
scaler kit.
‧ Incoming water supply line pressure to the
ultrasonic scaler must e 20 psi (138 kPa
minimum) to 40 psi (276 kPa) maximum. If your
dental water system's supply line pressure is
a ove 40 psi, install a water pressure regulator
on the water supply line to your ultrasonic scaler.
‧ A manual shut-off valve on the dental water
system supply line should e used so that the
water can e completely shut-off when the office
is unoccupied.
‧ A filter in the dental water system supply line is
recommended so that any particles in the water
supply will e trapped efore reaching the
ultrasonic scaler.
‧ After the a ove installations are completed on
the dental water supply system, the dental office
water line should e thoroughly flushed prior to
connection to the System.
‧ After flushing system verify there are no leaks.
8.3 Electrical Requirements
Refer to Section 3: Specifications.
8.4 Unpacking t e System
Carefully unpack your ELiTEDENT
®
ultrasonic
scaler and verify that all components and
accessories are included:
1. ELiTEDENT
®
MS-30 Ultrasonic scaler main unit
with Steriliza le Sleeve of Handpiece.
2. External power supply (AC-AC)
3. MS Handpiece Ca le Set.
4. Foot Pedal.
5. User Manual.
8.5 System Installation
‧ Place the ELiTEDENT
®
MS-30 on a level surface.
‧ Be sure unit is sta le and resting on four feet.
‧ Placing unit in direct sunlight may discolor plastic
housing.
8.6 Power Connection
‧ The ON/OFF Control Switch and power indicator
is located on the Rear Panel of the ELiTEDENT
®
MS-30 Ultrasonic Scaler. (See Section 9.1)
‧ Verify the ON/OFF Control Switch located on the
rear panel of the ELiTEDENT
®
MS-30 ultrasonic
scaler is in the OFF position efore proceeding.
‧ Plug the detacha le AC Cord into the ack of the
ultrasonic scaler and into an approved outlet.
8.7 Water Supply Line Connection
Connect the free end of the ultrasonic scaler’s
water supply line to the dental water supply line.
Inspect all connections to make certain there are
no leaks.

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S-19-01-1218-U0001 V 1.5
Section 9: ELiTEDENT
®
Ultrasonic Scaler Descri tion
9.1 Rear Panel
9.2 System Control
Foot Pedal Connector
Solenoid Water Inlet
Power Inlet
Power Switc
Power Adjustment
Turn the kno to select power
level for operation: clockwise
increases system power,
counterclockwise decreases
system power.
Sterilizable Sleeve
of Handpiece
Operates Ultrasonic
inserts and transmits
power and water flow
from the System to
the insert.
AC Power Indicator Light
Illuminates when the system
is switched on.
Sterilizable
Sleeve of
Handpiece Holder
Securely holds the
Hand piece when
system is not eing
used.
Water flow Adjustment
Turn the kno to select water
flow level during system
operation. Clockwise decreases
flow at insert tip,
counterclockwise increases the
flow.
The rate of flow through the
Handpiece determines the
temperature of the water flow.
Lower flow rates produce
warmer temperature; higher
flow rates produce cooler
temperature.
Turbo Indicator Lig t
Lit when Foot Switch is fully
depressed, and System is
functioning in “tur o”
mode.

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9.3 MS Handpiece Cable Set / Sterilizable Sleeve of Handpiece Assembly
The ultrasonic scaler is multi-frequency unit compati le with all Cavitron
®
inserts. The system will
automatically detect the insert, no need to switch any utton.
For more oral hygiene care, the handpiece sleeve can e dismantled and autoclaved. See elow:
To take off the handpiece sleeve, please hold the fastening ring, and rotate the sleeve counterclockwise
from MS handpiece ca le set assem ly. Note: Avoid rotate or twist t e MS andpiece cable.
9.4 Foot Pedal Controls and Operation
The Foot Pedal is a two-position momentary switch, which activates oth Ultrasonic energy and water flow
at insert tip.
Foot Pedal Released…
Both ultrasonic activation and
irrigating flow stop.
Foot Pedal Depressed Half Way (1
st
position)
The ultrasonic insert is activated
and irrigating water flow under
normal function.
Foot Pedal fully depressed
(2
nd
position)
This activates the “Tur o” mode
increasing extra power.
Section 10: Accessories
1. Ultrasonic insert (optional)
2. External Power Supply (AC-AC)
3. Foot pedal
4. MS Handpiece Ca le Set
5. Steriliza le sleeve of handpiece
Sterilizavle Sleeve
of Handpiece
Ena le to dismantle
and autoclave
Fastening Ring
Hold here, rotate handpiece
sleeve to release.
MS Handpiece Cable Set
Assembly
Include handpiece set, tu ing
and fastening ring.
O-ring

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Section 11: Techniques For Use
11.1 Patient Positioning
‧ For optimal access to oth the upper and lower
arches, the ackrest of the chair should e
adjusted to a 45 ∘ degree angle. This assures
patient comfort and Clinician visi ility.
‧ Have the patient turn his/her head to the right or
left. Also position chin up or down depending
upon the quadrant and surface eing treated.
Evacuate irrigate using either a saliva ejector or
High Volume Evacuator (HVE).
11.2 Performing Ultrasonic Scaling
Procedures
‧ Note: Refer to Section 7 and 12 for general
procedures to e followed at the eginning of
each day and etween patients.
‧ The edges of ultrasonic inserts are intentionally
rounded so there is little danger of tissue
laceration with proper ultrasonic scaling
technique. Whenever the insert tip is placed in the
patient’s mouth, the lips, check and tongue
should e retracted to prevent accidental
prolonged contact with the activated tip.
‧ Hold the empty steriliza le sleeve of handpiece in
an upright position. Activate the Foot Control until
fluid exits.
‧ Lu ricate the ru er O-ring on the insert with
water efore placing it into the steriliza le sleeve
of handpiece. Fully seat insert with a gentle
push-twist motion. DO NOT FORCE IT INTO PLACE.
‧ Activate the System. Hold the steriliza le sleeve
of handpiece over a sink or drain. Check spray
temperature to verify fluid is reaching the working
end of the insert tip. Adjust the water cooler
irrigate. Control kno to ensure adequate flow for
the selected Power setting. Greater flow settings
provide cooler irrigation.
‧ It may e necessary to adjust water flow larger
under "Tur o" mode (Foot Pedal fully depressed)
so adequate fluid will e availa le to cool tip and
tooth interface.
‧ In general, it is suggested a "feather-light-touch"
e used oth supra and su gingivally. 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.
‧ Periodically check the ultrasonic insert for wear
with the Insert Efficiency Indicator.
‧ The use of a saliva ejector or High Volume
Evacuator (HVE) is recommended during all
procedures.
‧ Set the System's Power Adjustment kno to the
lowest power setting for the application and the
selected insert.
‧ If water leakage found in handpiece, replace
sleeve or o-ring on handpiece ca le assem ly to
eliminate.
11.3 Patient Comfort Considerations
Reasons for sensitivity
‧ Incorrect tip placement. Point should e directed
away from root surfaces.
‧ Not keeping tip in motion on tooth. Do not allow
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 power setting
and/or move from the sensitive tooth to another
and then return.

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Section 12: System Maintenance and Care
Daily Maintenance
It is recommended that you perform the following
maintenance procedures to help minimize io-film
formation in the water path of your ELiTEDENT
®
ultrasonic scaler which could affect the water flow to
the ultrasonic insert, and scaling performance.
Start-Up Procedures at t e beginning of t e
day:
1. Open the manual shut-off valve on the dental
office water supply system.
2. Turn the system ON using the power ON/OFF
switch. (see illustration on page 7) Verify the Power
Indicator Light is on.
3. Set the Power Control kno to minimum setting.
4. Set the Water Control kno to maximum.
5. Hold the Steriliza le sleeve of Handpiece (without
an insert installed) upright over a sink or drain.
Activate the Foot Control and flush the water line for
at least 2 minutes.
6. Place a sterilized insert into the Steriliza le sleeve
of Handpiece and set the water control kno to your
preferred operating position.
Between Patients:
1. Remove ultrasonic insert and steriliza le sleeve of
handpiece used, clean and sterilize.
2. Clean and disinfect the surfaces of the ca inet,
Power Cord, MS Handpiece ca le Set assem ly*,
control kno s, Foot Pedal and MS Handpiece ca le
set ssem ly y applying an approved
non-immersion type disinfectant solution*
carefully following the instructions provided y
the disinfectant solution manufacturer. To clean
system, generously spray disinfectant solution on
a clean towel and wipe all surfaces. Discard used
towel. To disinfect system, generously spray
disinfectant on a clean towel and wipe all surfaces.
Allow disinfectant solution to air dry. Do not spray
disinfectant solution directly on the ultrasonic
scaler.
3. Place a sterilized steriliza le sleeve of handpiece.
Set power to minimum. Hold the steriliza le
sleeve of handpiece over a sink or drain and flush
the water line at maximum water flow for 30
seconds.
4. When ready, place a sterilized insert into the
steriliza le sleeve of handpiece.
5. Please consider use a FDA approved sheath to for
the ca le and entire handpiece or at least to cover
the handpiece from the fastening ring to ca le
when sleeve is sterilized etween patients.
*Note: If the Power Intensity Adjustment Knob is set to
minimal, it might get chance you can not activate the
system well, like no water flow or not vibrating. In that
case, please set the Power Intensity Adjustment Knob to
middle, then activate the Foot Control and then turn the
Power Intensity Adjustment Knob to your preferred setting.
S ut-Down Procedures at t e end of t e day:
1.Remove ultrasonic insert and steriliza le sleeve of
handpiece used, clean and sterilize.
2. Turn the System OFF.
3. Clean and disinfect the surfaces of the ca inet,
Power Cord, MS Handpiece ca le set assem ly,
control kno s, Foot Padel MS ca le set assem ly
y applying an approved non-immersion type
disinfectant solution* carefully following the
instructions provided y the disinfectant solution
manufacturer. To clean system, generously spray
disinfectant solution on a dean towel and wipe all
surfaces. Discard used towel. To disinfect system,
generously spray disinfectant on a clean towel
and wipe all surfaces. Allow disinfectant solution
to air dry. Do not spray disinfectant solution
directly on the ultrasonic scaler.
4. Close the manual shut-off valve on the dental
water supply system.
*Note: Those Water- ased disinfection solutions

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are preferred, due some alcohol- ased disinfectant
solutions may e harmful and may discolor plastic
materials.
*Note: The electric wire winding covered y heat
shrinkage tu e which protected y steriliza le
sleeve of handpiece is very sensitive to the
disinfectant solution and water. After the
disinfection, wipe surface of shrinkage tu e with a
slightly damp cloth and dry thoroughly efore use.
Section 13: Trouble shooting
Although service and repair of the ELiTEDENT
®
Ultrasonic Scaler should e performed y ROLENCE
dealer personnel, the following are some asic
trou le shooting procedures that will help avoid
unnecessary service calls. Generally, check all lines
and connections to and from the system, a loose
plug or connection will often create pro lems. Check
the settings on the system's kno s.
13.1 Troubles ooting Guide
Problem: System will not operate:
(Power Indicator Lig t is not lit.)
1. Check that the Power switch is in the ON position,
and that the AC Power Cord is fully seated in the
receptacle on ack of System.
2. Check that the System's three-prong plug is fully
seated in an appropriate AC receptacle, and that
AC current is present.
(Power Indicator Lig t is lit.)
1. Check that the Foot Pedal Connector is fully
seated in the Foot Pedal Receptacle on the ack of
the System.
2. Check foot pedal.
System operates:
(No water flow to insert .)
1. Assure that water control is properly adjusted.
2. Check that water supply control valve(s) (dental
office water supply) are open.
(Insert stops vibrating)
1. Deactivate foot pedal.
2. Verify insert is in good condition.
3. Depress foot pedal to try again
Section 14: Dis osal of Unit
‧ Keep original packaging until the ELiTEDENT
®
Ultrasonic Scaler is to e disposed of permanently. You
can use it for shipping or storing your ELiTEDENT
®
Ultrasonic Scaler at any time.
‧ Dispose of the ELiTEDENT
®
Ultrasonic Scaler in accordance with local and national laws.
Section 15: Disclaimer
ROLENCE considers itself responsi le for the effects on safety, relia ility and performance of this product
only if:
‧ Assem ly operations, extensions, re-adjustments, modifications or repairs are carried out y persons
authorized y ROLENCE.
‧ The electrical installation of the relevant room complies with the requirements.
The equipment is used in accordance with these instructions for use.

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Section 16: Warranty
16.1 Malfunction
Rolence here y warrants that for a period of one year from the delivery date, this device shall e free from
defects in material and workmanship. In case the machine is found malfunctioned under normal use,
Rolence will offer service of free maintenance and parts for replacement.
16.2 Repair
Repairs must e only carried out y an authorized Rolence engineer/dealer. If repairs during warranty
period are not carried out y an authorized engineer/dealer, warranty will expire immediately.
16.3 Warranty Exception
The warranty stated herein is the sole warranty applica le to Rolence products. Rolence expressly
disclaims the lia ility for warranty even within warranty period, if
(1) Damages caused y natural disaster.
(2) Operator's fault or wrong operation.
(3) Application use other than curing light-cured material purpose.
(4) A malfunction or damage caused y repair, adjustment, modification which is not carried out y
Rolence authorized technicians/dealers.
(5) A malfunction caused y a normal power source or voltage.
(6) It is a consumption part.
(This instruction su jects to change without pre-notice.)
T e equipment complies wit t e requirements in t e Medical Device Directive 93/42 EEC.
1434
Rolence Enterprise Inc.
No. 18-3, Lane 231, Pu Chung Rd.,
Chungli, Taoyuan 32083, Taiwan.
EU aut orized representative name and address
CMC Medical Devices & Drugs S.L.
C/ Horacio Lengo n18, C.P 29006, Málaga-Spain
REM: Please contact our authorized dealer if users require user manual in other European language.

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ANNEX I
Guidance and manufacturer’s declaration-electromagnetic emissions
The MS-30 is intended for use in the electromagnetic environment specified elow.
The customer or the user of the MS-30 should assure that it is used in such an
environment.
Emission test Compliance Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1 The MS-30 uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in near y
electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations
/flicker emissions
IEC 61000-3-3
Compliance
The MS-30 is suita le for use in all esta lishments,
including domestic esta lishments and those directly
connected to the pu lic low-voltage power supply
network that supplies uildings used for domestic
purposes.
Guidance and manufacturer’s declaration-electromagnetic immunity
The MS-30 is intended for use in the electromagnetic environment specified elow.
The customer or the user of the MS-30 should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance level Electromagnetic
environment-guidance
Electrostatic
discharge(ESD)
IEC 61000-4-2
+ 6 kV contact
+ 8 kV air
+ 6 kV contact
+ 8 kV air
Floors should e wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should e at
least 30%
Electrical fast
transient/ urst
IEC 61000-4-4
+ 2kV for power
supply
lines
+ 2kV for power
supply
lines
Mains power quality should e
that of a typical commercial or
hospital environment.
Surge IEC 61000-4-5 0.5~+ 2kV common
mode
0.5~+ 2kV common
mode
Mains power quality should e
that of a typical commercial or
hospital environment.
Voltage Dips, short
interruptions and
voltage
variations on power
<5% UT(>95% dip in
UT) for 0,5 cycle
40% UT(60% dip in
UT) for 5 cycles
<5% UT(>95% dip in
UT) for 0,5 cycle
40% UT(60% dip in
UT) for 5 cycles
Mains power quality should e
that of a typical commercial or
hospital environment. If the user
of the MS-30 requires continued

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supply
input lines IEC
61000-4-11
70% UT(30% dip in
UT) for 25 cycles
<5% UT(>95% dip in
UT) for 5 s
70% UT(30% dip in
UT) for 25 cycles
<5% UT(>95% dip in
UT) for 5 s
operation during power mains
interruptions, it is recommended
that the MS-30 e powered
from an uninterrupti le power
supply or a attery.
Power
frequency(50/60 Hz)
magnetic field IEC
61000-4-8
3 A/m 3 A/m The MS-30 contains no devices
suscepti le to magnetic fields.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration-electromagnetic immunity
The MS-30 is intended for use in the electromagnetic environment specified elow.
The customer or the user of the MS-30 should assure that is used in such and environment.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic environment-guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V/m
150 KHz to 80
MHz
3 V/m
80MHz to 2,5
GHz
3 V/m
3 V/m
Porta le and mo ile RF communications
equipment should e used no closer to any part of
the MS-30 including ca les, than the
recommended separation distance calculated
from the equation applica le to the frequency of
the transmitter. Recommended separation
distance:
d = 1,2 ˇP
d = 1,2ˇP 80MHz to 800 MHz
d = 2,3 ˇP 800MHz to 2,5 GHz
Where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined y an electromagnetic site survey,
(a) should e less than the compliance level in
each frequency range. ( ) Interference may
occur in the vicinity of equipment marked with
the following sym ol:
NOTE1

16
S-19-01-1218-U0001 V 1.5
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected y
a sorption and reflection from structures, o jects and people.
a. Field strengths from fixed transmitters, such as ase stations for radio (cellular/cordless) telephones
and land mo ile radios, amateur radio, AM and FM radio roadcast and TV roadcast cannot e predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should e considered. If the measured field strength in the location in which
the MS-30 should e o served to verify normal operation. If a normal performance is o served, additional
measures my e necessary, such as re-orienting or relocating the MS-30.
. Over the frequency range 150 kHz to 80 MHz, field strengths should e less than 3 V/m.
Recommended separation distance between
portable and mobile RF communications equipment and t e MS-30
The MS-30 is intended for use in an electromagnetic environment in which radiated RF
distur ances are controlled. The customer or the user of the MS-30 can help prevent
electromagnetic interference y maintaining a minimum distance etween porta le and mo ile
RF communications equipment (transmitters) and the MS-30 as recommended elow,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
m
Rated
maximum
output
power of
transmitter
W
150 kHz to 80 MHz
d =1,2ˇP
80 MHz to 800 MHz
d =1,2ˇP
800 MHz to 2,5 GHz
d =2,3ˇP
0,01 0.12 0.12 0.23
0,1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed a ove, the recommended
separation distance d in metres (m) can e estimated using the equation applica le to the
frequency of the transmitter, where p is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected y a sorption and reflection from structures, o jects and people.