(Seriel 2000/3000 )

RF-SN2-M002 Edition: V2.2 Modify: 20210810

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Contents
1 Product introduction ················································································· 4
2 Installation and adjustment········································································· 8
3 Function and Operation·············································································1 44 Cleaning, disinfecting and sterilizing····························································1 6
5 Transportation, storage and maintenance ····················································1 7
6 Trouble shooting ·····················································································1 8
7 Environmental protection···········································································2 0
8 European authorized representative····························································2 0
9 EMC - Declaration of conformity·································································2 1
10 Manufacturer’s right················································································2 6
Attachment 1. Table of operating power of the tips (Compatible with EMS)·············2 7
Attachment 2. Table of operating power of the tips (Compatible with SATELEC)······2 8
Attachment 3. Reprocessing Instructions of Cleaning, Disinfecting And Sterilizing····3 0

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Safety Precautions
WARNING: If you neglect these safety precautions, you may cause personal injury such as
electric shock, fire or damage to the product.
1.Use a separate, grounded power outlet. Never use wet hands to unplug the power cord.
2.Please do not use other than the specified voltage.Before connecting the built-in ultrasonicscaler without transformer to power supply, please check the output voltage is 24VAC, in caseof connecting to wrong power supply and that may break the unit.
3.Keep the scaler clean before and after operation. The scaling tip, wrench and handpiece must
be sterilized before each treatment.
4.The tip must be tightened to the handpiece with torque wrench. While scaler is working, theheat of scaling tip may become higher if there is no water flowing out, make sure the irrigationis good.
5.Don't twist or rub the tip. Change a new one when the tip is damaged or worn excessively.
6.Don't screw the scaling tip while stepping on the foot switch.
7.Don't use impure water source, and be sure not to use normal brine instead of pure water
source.
8.While scaler is working, the heat of scaling tip will become higher if there is no water flowing
out, make sure the irrigation is good.
9.Don't knock or rub the handpiece. Do not pull the cable while the device is working, to avoid
damage to the cable.
10.The screw thread of the scaling tips produced by other manufacturers maybe coarse, rusty
and collapsed, which will damage the screw thread of the handpiece irretrievably. Please use
our scaling tip.
11.As a professional manufacturer of medical instruments, we are only responsible for thesafety on the following conditions:• The maintenance, repair and modification are made by the manufacturer or the authorized
dealer.
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• The changed components are original of our company and operated correctly according to
instruction manual.
12.This product is intended for use in hospitals and dental clinics only. The user must be
professionally trained and qualified dentists.

WARNING: No modification of this equipment is allowed.
WARNING: If this equipment is modified, appropriate inspection and testing must be
conducted to ensure continued safe use of equipment.

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Symbol instruction
Symbol24VAC

Instruction

SymbolInstruction

Warning, Caution and Important!
Check the Instruction Manual

Consult the accompanying
documents

Date of manufacture

Manufacturer

According to the type ofprotection against electric shock:
CLASS II EQUIPMENT

According to the degree ofprotection against electric
shock:Type B applied partProtected against dripping water

Used indoor only

24VAC power supply socket

Can be autoclaved

Atmospheric pressure for storage

Water entrance
pressure:0.01MPa-0.5MPa

Temperature limitation for storage

Humidity limitation for storage

Appliance compliance WEEE
directive, Dispose as requiredby the law.

CE Mark3

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1 Product introduction
1.1 Product overview

The built-in ultrasonic scaler is used along with dental unit for teeth cleaning and root canaltreatment. They are also indispensable equipments for tooth disease prevention and treatment.
The ultrasonic scaler is intended to be built in a dental unit which shall comply with IEC 606011 and IEC 80601-2-60. The product supposes to be used in hospital and dental clinic, should
be used by trained and qualified dentist.This Ultrasonic Scaler is used for the dental calculus
elimination and root canal treatment. The ultrasonic scaler is composed of main unit, handpiece(ultrasonic transducer), cable, scaling tip, transformer (optional), foot switch (optional), water
pipe and torque wrench.
The ultrasonic scaler has following features:
1) Detachable handpiece can be autoclaved under 134 °C and 0.22 Mpa.
2) Automatic frequency tracking ensures that the device always works on the best frequency,
stable and efficient performance.

1.2 Contraindications:1) The hemophilia patient is forbidden to use this equipment.
2) The patients or doctors with heart pacemaker are forbidden to use this equipment.
3) The heart disease patient, pregrant woman and children should be cautious to use theequipment.

1.3 Equipment safety classification

1) Operating mode: Continuous operation
2) Type of protection against electric shock: Class II3) Degree of protection against electric shock: Type B applied part4

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4) Applied part of the equipment: Tip
5) Degree of protection against harmful ingress of water: Ordinary equipment
6) Degree of protection against harmful ingress of water: protection degree against water(used on foot switch ): IPX1
7) Degree of safety of application in the presence of a flammable anesthetic mixture with
air or with oxygen or nitrous oxide: Equipment can not be used in the presence of a flammableanesthetic mixture with air or with oxygen or nitrous oxide.

1.4 Working condition

1) Environment temperature: +5°C - +40°C2) Relative humidity: 30% - 75%
3) Atmosphere pressure: 70kPa - 106kPa
4) Temperature of the water at the inlet: not higher than +25°C

1.5 Model and technical Parameters (For specific models, see packing
labels. )Note 1: In addition to the above, the electronic components used to clarify their electricalproperties are exactly the same.
Note 2: Function Annotation: “G” means “Scaling Function” ; “P” means “Periodontal Function” ;“E” means “Endodontic Function”.
Note 3: Do not replace the fuse of main unit, to avoid safety risks.

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Table 1: Technical Parameters of each model ( Serial 2 )Parameters
Compatible Brand
Handpiece
Function

Potentiometer
Size (mm)Weight of main unit
Power input
Fuse of main unit
Primary tip vibration
excursion
Tip vibration frequency
Output power of tip
Half-excursion force
Water entrance
pressure

N2000
EMS
HP-3H (without
LED lamp,
Detachable)

N2000LEMS
HP-5L(withLED lamp,
Detachable)

V2000
Satelec
HS-7H(without
LED lamp,
Detachable)

V2000L
Satelec
HS-7L(withLED lamp,
Detachable)

G, P

G, P

G, P

G, P

Carbon-film
potentiometer(circular)
75*56*34mm
0.125kg
24VAC
50Hz/60Hz
1.3A
T1.6AL 250V

Carbon-film
potentiometer(circular)
75*56*34mm
0.125kg
24VAC
50Hz/60Hz
1.3A
T1.6AL 250V

Carbon-film
potentiometer(circular)
75*56*34mm
0.125kg
24VAC
50Hz/60Hz
1.3A
T1.6AL 250V

Carbon-film
potentiometer(circular)
75*56*34mm
0.125kg
24VAC
50Hz/60Hz
1.3A
T1.6AL 250V

<200μm<200μm<200μm<200μm28kHz±3kHz
3W-20W
0.5N-5N

28kHz±3kHz
3W-20W
0.5N-5N

28kHz±3kHz
3W-20W
0.5N-5N

28kHz±3kHz
3W-20W
0.5N-5N

0.01-0.5MPa

0.01-0.5MPa

0.01-0.5MPa

0.01-0.5MPa

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Table 2: Technical Parameters of each model ( Serial 3 )Parameters
Compatible Brand
Handpiece
Function

Potentiometer
Size (mm)Weight of main unit
Power input
Fuse of main unit
Primary tip vibration
excursion
Tip vibration
frequency
Output power of tip
Half-excursion force
Water entrance
pressure

N3000
EMS
HP-3H (without
LED lamp,
Detachable)

N3000LEMS
HP-5L(withLED lamp,
Detachable)

V3000
Satelec
HS-7H(without
LED lamp,
Detachable)

V3000L
Satelec
HS-7L(withLED lamp,
Detachable)

G, P, E

G, P, E

G, P, E

G, P, E

Push-pull
potentiometer
75*56*34mm
0.125kg
24VAC
50Hz/60Hz
1.3A
T1.6AL 250V

Push-pull
potentiometer
75*56*34mm
0.125kg
24VAC
50Hz/60Hz
1.3A
T1.6AL 250V

Push-pull
potentiometer
75*56*34mm
0.125kg
24VAC
50Hz/60Hz
1.3A
T1.6AL 250V

Push-pull
potentiometer
75*56*34mm
0.125kg
24VAC
50Hz/60Hz
1.3A
T1.6AL 250V

<200μm<200μm<200μm<200μm28kHz±3kHz

28kHz±3kHz

28kHz±3kHz

28kHz±3kHz

3W-20W
0.5N-5N

3W-20W
0.5N-5N

3W-20W
0.5N-5N

3W-20W
0.5N-5N

0.01-0.5MPa

0.01-0.5MPa

0.01-0.5MPa

0.01-0.5MPa

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2 Installation and adjustment
2.1 Working principle

2.1.1 Summarization: the built-in ultrasonic scaler is consist of ultrasonic generator (circuit),
cable, handpiece (energy-transformed instrument), scaling tip, pneumatic switch (the powerswitch of pneumatic penstock and the circuit’s commutating and filtering, is controlled bypneumatic foot pedal of dental unit and switch for handpiece rack of ultrasonic scaler at
the same time) and switch for handpiece rack (it controls the air supply which gets throughpneumatic penstock and pneumatic power switch. And the air supply is off when handpiece is in
the rack and on when handpiece is out).
2.1.2 Chart of working principle:
The air supply is on when the handpiece is out from the rack. Step on the foot switch,
pneumatic power switch, pneumatic penstock, ultrasonic generator, handpiece and scaling tip
all start working at the same time, and water supply is opened the LED lamp on the top of the
handpiece with LED shines.

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2.2 Installation

2.2.1 Cutting sleeve use instructiona) Put the cutting sleeve through the water pipe, keep it 10mm to 20mm away from theentrance.
10-20mm

Cutting sleeve
Water pipe(End of the handpiece cable)

Water exit connectorb) Put the water pipe in the middle of the water exit connector(about 3mm), then push the
cutting sleeve forward to the front edge of the water exit connector.
c) Pinch the cutting sleeve and the water pipe with your fingers, push them forward at the sametime until they are wrapped into the water exit connector fully. Then the cutting sleeve is in the
middle of the water exit connector.

Notice:Cut off the forepart of the water pipe about 6 mm if repeat the above operation.
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2.2.2 The main components of this equipment and installation are showed as picture 1:

Notice:a) Please connect power and pneumatic switch (or foot switch) showed as picture 1.
b) The No.7 lead and No.8 lead should be connected with 24VAC, and this circuit isn’t allowed
to act as switch circuit.
c) The No.9 lead and No.10 lead should be connected with pneumatic switch (or foot switch)
directly, and this circuit isn’t allowed to do the short circuit.
d) Wires 11 and 12 are the solenoid valve drive wires and are not normally used. This outputs
30V DC, must not be connected to a power supply or switch and must not be shorted.
e) Pins 13, 14 and 15 of the N3000 series are for mode selection (black, green and orange
wires) and are connected to the toggle switch, the black wire marked "G/P" is for ultrasonicscaling or periodontal treatment mode, the middle of the orange wire is empty and the green
wire marked to the position marked "E" for root canal scaling mode.
f) Pins 19, 20 and 21 are connected to a potentiometer for power adjustment. The
potentiometer increases power when adjusted clockwise and decreases power when adjusted
counterclockwise.
g) The followings should be noticed during installation.
① Pneumatic power switch, pneumatic penstock and pneumatic foot switch are equipped bymanufacturers of the dental unit or the end-users.
② The manufacturers of dental unit, the dealers or end-users of the equipment need to drill
holes in salver of dental unit so as to fix potentiometer and fetch out the silica gel pipe of
handpiece pipe.
③ Keep enough space for dispersing heat of ultrasonic generator.
④ Built-in ultrasonic scaler without transformer occupies some space, and works withcurrent 24VAC, power ≥20W.
⑤ Before turning on the scaler, turn the potentiometer knob to the minimum and the water
control switch to the maximum.
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⑥ The frequency of ultrasonic scaler is extremely high. Under normal water supply, alight touch and a certain to-and-fro motion will eliminate the tartar without obvious heat.
Overexertion and longtime lingering are forbidden.

picture 1

2.3 Instruction for main components of handpiece (showed in picture 2).

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Picture 2-A The detachable handpiece without LED lamp

Picture 2-B The detachable handpiece with LED lampa) Cap: The Cap can be removed. You can screw out the Cap and clean the pole with alcohol
termly.
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b) Decorative ring: can be disassembled and cleaned with alcohol regularly, can be autoclaved
under the high temperature and pressure.
c) Handpiece: The main part of the whole handpiece, can be autoclaved under the hightemperature and pressure.
d) Symbol: Autoclaved (134°C,0.22MPa)e) The connector of the cable: Connect the handpiece with the water source and power of themain unit.
f) LED lamp, Light conductor (The models that the handpiece with LED lamp): Clean them withpurified water and sterilize them under the high temperature of 134°C and high pressure of
0.22Mpa.

Note: The connection of handpiece and the plug must be kept dry.

2.4 Instruction for using the wrench to install tip

Picture 3a) The torque wrench’s structure is designed in special way which can control the strength of13

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the scaling tip installation properly and correctly. It also can guarantee the operator screw or
unscrew the scaling tip effectively and keep their hands away from being scratched.
b) Operation•Take the tip into the torque wrench then install or uninstall the scaling tip as picture 3 showed.
•Installation: Hold the handpiece and turn the tip toward clockwise direction with the torquewrench. Turn one more circle when the tip stops, then the tip is installed.
•Uninstallation: Hold the handpiece, turn the wrench toward anti-clockwise direction.

Note: The connection of handpiece and the plug must be kept dry.

3 Function and Operation
3.1 Scaling function

3.1.1 Choose the scaling tip according to the requirement, and fix the scaling tip with thewrench. ( see picture 3) Please select a suitable power when using different type of tips (refer to"TABLE OF OPERATING POWER OF THE TIPS").
3.1.2 The handpiece can be handled in the same gesture as a pen in hand.
3.1.3 Vibrating intensity: Using the potentiometer to adjust the vibrating intensity according
to your need, usually adjust to the middle grade, and adjust the vibrating during the clinicaltreatment according to the patient's sensitivity and the rigidity of the tartar.
3.1.4 Step on the foot switch, the tip begins to vibrate, and the LED lamp (model with LED) on
the top of the handpiece lights up. Release the foot switch, the LED lamp keep shining for 10
seconds.
3.1.5 Under normal working condition, the frequency of the tips is very high, light touch anda certain to-and-fro motion will eliminate the tartar without obvious heating, overexertion andoverstay are forbidden.
3.1.6 Water volume adjustment: Step on the foot switch, and the tip begins to vibrate, then turn14

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the water control switch to fine spray to cool down the handpiece and clean the teeth.
3.1.7 After finishing operation, keep the machine working for 30 seconds with the water supply
to clean the handpiece and the tip.
3.1.8 Unscrew the scaling tip and sterilize it.
Be sure not to make the end of the tip touch the teeth vertically, and not use toomuch force when the tip touch the surface of the teeth, in case of hurting the teeth anddamaging the tip.

Note: Don't screw the scaling tips when stepping on the foot switch, while the machine
is working.

3.2 Endodontic function (The models with endodontic function)

3.2.1 Usage processa) Fix endo holder to handpiece by endo wrench.
b) Unscrew the screw cap on the endo holder.
c) Put the ultrasonic file into the hole in the front of endo holder.
d) Screw the screw cap with endo wrench to tight up the ultrasonic file.
e) Pull out the main pole of the power potentiometer to switch to endo function (when push itin, switch to scaling function), then turn the potentiometer toward anticlockwise direction to theminimum grade.
f) Step on the foot switch to start endo treatment.
g) Use for endo function when step on foot switch. During the treatment, turn up the power
gradually according to the needs.

3.2.2 Noticea) When fixing endo chuck, it must be screwed down.
b) The screw cap on the endo chuck must be screwed down.
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c) Don’t press it too hard when the ultrasonic file is in root canal.
d) Don’t step on the foot switch until the ultrasonic file is in the root canal.

4 Cleaning, disinfecting and sterilizing
4.1 Please conform to the recommendations of the manual "Reprocessing Instructions ofCleaning, Disinfecting And Sterilizing" delivered with your product regarding the procedure ofcleaning, disinfecting, sterilizing and packing of the components. Follow present-day regulations
enforced in the country about reprocessing. The use of scouring powder or an abrasive sponge
will damage its surface.
4.2 The handpiece, scaling tips, endochuck, torque wrench, endo wrench, LED lamp and Light
conductor can be sterilized(the handpiece with LED lamp). The cable and water pipe cannot besterilized.

Notice:a) Clean the handpiece with compressed air before sterilization.
b) Be sure that the scaling tip has been unscrewed from the handpiece and it cannot besterilized with others.
c) Please notice whether the outer of the handpiece is damaged during the treatment andsterilization. Don’t smear any protective oil on the surface of handpiece.
d) There are some waterproof “O” rings at the end of the handpiece. Please lubricate them withdental lube frequently, as sterilization and repeated pulling and inserting will reduce their using
life. Change a new one once it is damaged or worn excessively.
e) The following sterilizing methods are forbidden:•Boil in water.
•Dip in iodine, alcohol and glutaraldehyde.
•Bake in oven or microwave oven.
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Notice: We are not responsible for any damage caused in the above items.

5 Transportation, storage and maintenance
5.1 Transportation

5.1.1 Excessive impact and shake should be prevented in the transportation. Lay it carefully
and lightly and don’t invert it.
5.1.2 Don’t put it together with dangerous goods during transportation.
5.1.3 Avoid solarization and getting wet in rain or snow during transportation.

5.2 Storage

5.2.1 Don’t store the machine together with the articles that is combustible, poisonous, caustic,or explosive.
5.2.2 This equipment should be stored in a room where the relative humidity is 10%-93%,
atmospheric pressure is 70kPa-106kPa, and the temperature is -20°C-+40°C.

5.3 Maintenance5.3.1 The equipment should be handled carefully and lightly. Be sure that it is far from thevibration, and installed or kept in a cool, dry and ventilated place.
5.3.2 Please turn off the electrical source if not use it, if not use for a long time, please make themachine get through to the power and water once 3 months for five minutes.

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6 Trouble shooting
Fault

Possible causes
The plug is in loose
or wrong contact.
Handpiece and the connector ofcable connect irrelevantly.

Solutions
Connect as picture 1 showed.
Pull out handpiece andinsert it again.
Screw it on tightly withtorque wrench.

The scaling tip doesn’t
Scaling tip is loose.
vibrate when stepping on
the foot switch.
There is some water between thehandpiece and the connector of Dry the connect point.
cable.
There is something wrong with
Send it to our company
detachable handpiece.
to repair.
Water supply of dental
Check the water supply of theunit is off.
dental unit.
Clean the water pipe
The scaling tip vibrates, There is no water coming out fromof the cable withthe cable.
but there is no water
multi-function syringes.
flowing out.
Clean the water pipe
There is no water coming out fromof the handpiece
the handpiece.
with multi-function syringes.
The handpiece
The amount of spouting water is Turn the water control switch to a
generates heat.
too little.
higher grade.

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FaultPossible causes
The water pipe of dental unit isjammed.
The water pipe of cable
The amount of spouting is jammed.
water
The water pipe of handpiec
is too little.
is jammed.

The vibration of the tip
becomes weak.
There is water seepingfrom the coupling
between the handpieceand cable.
The potentiometeris failure.

The water pressure is nothigh enough.
The tip hasn't beenscrewed tightly.
The tip vibrates loose.
The tip is damaged.

SolutionsClean the water pipe.
Clean the water pipe of the cablewith multi-function syringe.
Clean the water pipe of the
handpiece withmulti-function syringe.
Enhance the water pressure.
Screw down the scaling tip.
Screw down the scaling tip.
Change a new one.

The waterproof "O" ring isdamaged.

Change a new "O" ring.

The potentiometeris damaged.

Change a new one.

The U-file doesn’t
The screw hasn’t been screwed.
vibrate. (The models that
Endochuck is damaged.
with Endodontic function)

Screw it tightly.
Change a new endochuck.

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Fault
LED light don't work
(The models that the
handpiece without LED
lamp)
There is noise comingfrom the endochuck.
(The models that with
Endodontic function)

Possible causes
Poor contact
Something wrong
with LED light

SolutionsContact tightly
Change a new one

LED lamp installedbackwards

Please install the "+" of
the LED lamp to the "+" of the
handpiece

The screw cap hasn’t beenscrewed tightly.

Screw it tightly.

If the problem still can’t be solved, please contact with local dealer or manufacturer.

7 Environmental protection
Please dispose according to the local laws.

8 European authorized representative20

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9 EMC - Declaration of conformity
The device has been tested and homologated in accordance with EN 60601-12 for EMC. This does not guarantee in any way that this device will not be effectedby electromagnetic interference Avoid using the device in high electromagnetic
environment.
Guidance and manufacturer’s declaration - electromagnetic emissions
The models Ultrasonic Scaler are intended for use in the electromagnetic environment
specified below. The customer or the user of the models Ultrasonic Scaler should assure that it
is used in such an environment.
Emissions test
ComplianceElectromagnetic environment - guidance
The models Ultrasonic Scaler use RF energy only for
its internal function. Therefore, its RF emissions are
RF emissions CISPR 11
Group 1very low and are not likely to cause any interferencein nearby electronic equipment.
RF emissions CISPR11
Class BThe models Ultrasonic Scaler are suitable for being
Harmonic emissions lEC
Class A
used in domestic establishment and in establishment
61000-3-2
directly connected to a low voltage power supply
Vo l t a g e f l u c t u a t i o n s /network which supplies buildings used for domesticf l i c k e r e m i s s i o n s l E C Complies purposes.
61000-3-3

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Guidance & Declaration — electromagnetic immunity
The models Ultrasonic Scaler are intended for use in the electromagnetic environment
specified below. The customer or the user of the models Ultrasonic Scaler should assure that It
is used in such an environment.
IEC 60601 test
Electromagnetic environment
Immunity test
Compliance level
level- guidance
Floors should be wood,concrete or ceramic tile.
±8 kV contact±8 kV contact ±2 kV,Electrostatic
If floors are covered with
discharge (ESD)±2 kV, ±4 kV, ±8 kV, ±4 kV, ±8 kV, ±15 kV
synthetic material, the relativeair±15 kV airlEC 61000-4-2
humidity should be at least 30%.
±2kV for power±2kV for power
Mains power quality should be
supply lines
Electrical fast
supply linesthat of a typical commercial or±1kV fortransient/burst±1 kV for Input/
hospital environment.
interconnecting
IEC 61000-4-4
output lines
cable
Mains power quality should be
Surge±1 kV line to line
±1 kV line to linethat of a typical commercial orlEC 61000-4-5±2 kV line to earth
hospital environment.

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<5 % UT(>95% dip in UT.)
for 0.5 cycle
Voltage dips, short 40 % UTinterruptions and(60% dip in UT) forvoltage variations 5 cycles
on power supply
70% UT
input lines(30% dip in UT) for
IEC 61000-4-11.
25 cycles<5% UT(>95 % dip in UT)
for 5 sec

<5 % UT
Mains power quality should be(>95% dip in UT.) forthat of a typical commercial
0.5 cycle
or hospital environment.
40 % UT
If the user of the models(60% dip in UT) for 5
Ultrasonic Scaler requires
cyclescontinued operation during
70% UT
power mains interruptions, it is(30% dip in UT) forrecommended that the models
25 cycles
Ultrasonic Scaler is powered<5% UT
from an uninterruptible power(>95 % dip in UT)
supply or a battery.
for 5 sec
Power frequency magnetic
Power frequency
fields should be at levels(50/60 Hz)
30A/m
30A/m
characteristic of a typicalmagnetic field
location in a typical commercial
lEC 61000-4-8
or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

Guidance & Declaration - Electromagnetic immunity
The models Ultrasonic Scaler are intended for use in the electromagnetic environment
specified below. The customer or the user of the models Ultrasonic Scaler should assure that it
is used in such an environment.
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ComplianceElectromagnetic environment - guidancelevelPortable and mobile RF communications
equipment should be used no closer to any part ofthe models Ultrasonic Scaler, including cables, than
the recommended separation distance calculated
from the equation applicable to the frequency of thetransmitter.
Recommended separation distance
3 Vrmsd=[3,5/V1]×P1/2
Conducted RF 1 5 0 k H z t o
d=1.2×P1/2 80 MHz to 800 MHz
3 VrmslEC 61000-4-6 80 MHz
d=2.3×P1/2 800 MHz to 2.5 GHz
where P is the maximum output power rating of the
Radiated RF 3 V/mtransmitter In watts (W) according to the transmitter
3 V/mlEC 61000-4-3 8 0 M H z t o
manufacturer and d Is the recommended separation
2.5 GHzdistance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, ashould be less than the compliance level in eachfrequency range.b
Interference may occur in the vicinity of equipment
Immunity test

IEC 60601
test levelmarked with the following symbol:
NOTE 1 At 80 MHz end 800 MHz. the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation isaffected by absorption and reflection from structures, objects and people.

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aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones andland mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, anelectromagnetic site survey should be considered. If the measured field strength in the location in which
the models Ultrasonic Scaler are used exceeds the applicable RF compliance level above, the model
Ultrasonic Scaler should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the models Ultrasonic Scaler.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Recommended separation distances between
portable and mobile RF communications equipment and the models Ultrasonic Scaler

The models Ultrasonic Scaler are intended for use in electromagnetic environment in which radiated RF
disturbances is controlled. The customer or the user of the models Ultrasonic Scaler can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RFcommunications equipment (transmitters) and the models Ultrasonic Scaler are recommended below,
according to the maximum output power of the communications equipment.

Rated maximum
output powerof transmitter
W
0.01
0.1
1
10
100

Separation distance according to frequency of transmitterm
150kHz to 80MHz
80MHz to 800MHz
800MHz to 2.5GHz
d=1.2×P1/2
d=1.2×P1/2
d=2.3×P1/2
0.12
0.12
0.23
0.38
0.38
0.73
1.2
1.2
2.3
3.8
3.8
7.3
12
12
23

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For transmitters rated at a maximum output power not listed above, the recommended
separation distanced in meters (m) can be estimated using the equation applicable to thefrequency of the transmitter, where P is the maximum output power rating of the transmitter inwatts (W) accordable 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 isaffected by absorption and reflection from structures, objects and people.
The device has been tested and homologated in accordance with EN 60601-1-2 for EMC.
This does not guarantee in any way that this device will not be effected by electromagnetic
interference Avoid using the device in high electromagnetic environment.

10 Manufacturer’s right
We reserve the rights to change the design of the equipment, the technique, fittings, theinstruction manual and the content of the original packing list at any time without notice. If there
are some differences between blueprint and real equipment, take the real equipment as thenorm.
( The date of production can be found in the label of the package. Product lifetime: 10 years)

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Attachment 1. Table of operating power of the tips (Compatible with EMS)
ScalingCavity Preparation

Tip Model

Power

Tip Model

Power

G1

LOW-HIGH

SB1

G2

LOW-HIGH

SB2

G3

LOW-HIGH

G4

LOW-HIGH

G5

LOW-HIGH

G6

LOW-HIGH

G7

LOW-HIGH

G8G9Periodontics

Endodontics

Tip Model

Power

Tip Model

Power

LOW-HIGH

P1

LOW-MID

E1

LOW

LOW-HIGH

P2L

LOW

E2

LOW

SB3

LOW-HIGH

P2LD

LOW

E3

LOW

SBL

LOW-HIGH

P2R

LOW

E3D

LOW

SBR

LOW-HIGH

P2RD

LOW

E4

LOW

P3

LOW-MID

E4D

LOW

P3D

LOW-MID

E5

LOW

LOW-HIGH

P4

LOW-MID

E5D

LOW

LOW-HIGH

P4D

LOW-MID

E6

LOW

G10

LOW-HIGH

E7

LOW

G11

LOW-HIGH

E8

LOW

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E9

LOW

E10

LOW

E10D

LOW

E11

LOW

E11D

LOW

E14

LOW

E15

LOW

Attachment 2. Table of operating power of the tips (Compatible with SATELEC)
ScalingCavity Preparation

Tip Model

Power

Tip Model

Power

GD1

LOW-HIGH

SBD1

GD2

LOW-HIGH

SBD2

GD3

LOW-HIGH

GD4

LOW-HIGH

GD5

LOW-HIGH

GD6

LOW-HIGH

GD7

LOW-HIGH

GD8
GD9Periodontics

Endodontics

Tip Model

Power

Tip Model

Power

LOW-HIGH

PD1

LOW-MID

ED1

LOW

LOW-HIGH

PD2L

LOW

ED2

LOW

SBD3

LOW-HIGH

PD2LD

LOW

ED3

LOW

SBDL

LOW-HIGH

PD2R

LOW

ED3D

LOW

SBDR

LOW-HIGH

PD2RD

LOW

ED4

LOW

PD3

LOW-MID

ED4D

LOW

PD3D

LOW-MID

ED5

LOW

LOW-HIGH

PD4

LOW-MID

ED5D

LOW

LOW-HIGH

PD4D

LOW-MID

ED6

LOW

GD10

LOW-HIGH

ED7

LOW

GD11

LOW-HIGH

ED8

LOW

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ED9

LOW

ED10

LOW

ED10D

LOW

ED11

LOW

ED11D

LOW

ED14

LOW

ED15

LOW

Attachment 3. Reprocessing Instructions of Cleaning, Disinfecting
And Sterilizing
1. BEGINNING WORK!
1.1 Please read these operating instructions carefully as they explain all the most important details andprocedures. Please pay special attention to the safety precautions. Always keep this instruction close at
hand.
1.2 To prevent injury to people and damage to property, please heed the corresponding directives.
1.3 The instructions in this manual are only applicable to the equipment which it was delivered with.

2. INTRODUCTION
2.1 These reprocessing instructions provide instructions for cleaning, disinfection, sterilization andpackaging of manufacturer reusable products intended to be reprocessed in medical facilities.
2.2 The goal of reprocessing reusable products is to reduce bioburden and to achieve sterility of those
products in order to eliminate the risk of product reuse related infection. Decisions regarding cleaning,
disinfecting or sterilizing manufacturer's medical and dental instruments are based on the potential risk ofinfection associated with their use.
2.3 It is recommended to use steam sterilization.
2.4 Remember that sterilization or high-level disinfection cannot be achieved unless the elements of theassembly are cleaned first.
2.5 If you find that the reprocessing instructions from the manufacturer seem to be inadequate, please
inform manufacturer about those inadequacies.

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2.6 We encourage you to report adverse events related to device reprocessing. Report such events directly
to manufacturer.

3. REPROCESSING - INSTRUCTIONS FOR REUSABLE PRODUCTS
The instructions are binding for the reprocessing of all reusable products (Here after called "products") of
manufacturer. When necessary, additional product-specific instructions are included with the product toprovide additional information.
Important: Before use, carefully read the operating instructions of the manufacturer instrument anddevices with which the product will be used.
Reusable products must be cleaned and sterilized prior to first use. They must be replaced after the numberof operations specified by the manufacturer. Disposable products (single use) cannot be reused.

4. PREPARATION - Basic principles
4.1 It is only possible to carry out effective sterilization after the completion of effective cleaning anddisinfection. Please ensure that, as part of your responsibility for the sterility of products during use, only
sufficiently validated equipment and product-specific procedures are used for cleaning/disinfection andsterilization, and that the validated parameters are adhered to during every cycle.
4.2 Please also observe the applicable legal requirements in your country as well as the hygiene regulationsof the hospital or clinic. This applies especially with regard to the additional requirements for the inactivationof prions.

5. POST-OPERATIVE TREATMENT
The post-operative treatment must be carried out immediately, no later than 30 minutes after the completionof the operation. Additional information, while necessary, is provided in the respective product-specificusage instructions.

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Steps:1.Rinse away any surface soiling on the product with distilled deionized water or with a cleaning agent.
2.Rinse through all lumina (e.g. irrigation and aspiration connection) at least 3 times in the normal directionof flow (no back rinsing) using a disposable syringe (min. volume 50 ml) filled with distilled/deionized water
applied to the back nozzle.
3.An aldehyde-free cleaning and disinfection solution that is compatible with the products may also be used
as an alternative rinsing solution. In such cases, it is necessary to rinse thoroughly afterwards at least 3
times with distilled, or deionized water.

6. CLEANING/DISINFECTION:
6.1 MECHANICAL REPROCESSING
Disinfection must be performed no later than 2 hours after the cleaning phase.
A machine cleaning and disinfection method should always be used for cleaning / disinfection because of
the increased effectiveness of this method.
6.2 MECHANICAL CLEANING AND DISINFECTION
6.2.1 Thermal disinfection should be used if this function is available on your disinfector. Use if possible adisinfecting cycle compliant with the standard EN ISO 15883.
6.2.2 Note that there is a risk of disinfectant residue on products when using chemical disinfectants.
6.2.3 Ensure the following criteria are met when selecting a disinfector system:•Disinfector is proven effective through testing (e.g. FDA approved or CE marked / EN ISO 15883 compliant).
•Disinfector has suitable baskets to hold small fragile products and has rinsing connections for the31

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attachment to product lumina.
•The cleaning program is suitable for products to be processed and the rinsing cycle is sufficient.
•Only low microbe count (<10 cfu/ml) distilled or deionized water is used for all rinsing steps. (E.g. Aqua
purificata, as per the specifications of Pharm. Eur. or USP).
•Air used for drying is HEPA filtered.
•Disinfector is serviced and checked on a regular basis.
6.2.4 Ensure the following criteria are met when selecting a cleaning and disinfection agent:•Chemicals are compatible with products.
•With non-thermal disinfection, a suitable disinfectant with tested effectiveness (e.g. FDA approved or CE
marked), that is compatible with the cleaning agent, must be used.
Concentrations and contact times specified by the manufacturer of the cleaning anddisinfection agent must be followed. Only freshly prepared solutions may be used.
6.2.5 Steps for mechanical cleaning and disinfection with a disinfector
1) Load the WD with the instruments on the tray and start the WD with a full load. Run the cleaning cycleof the "surgical instrument" programme in accordance with the manufacturer's instructions.
Instrument cleaning program:• pre-wash (5 minutes, ambient temperature water)• cleaning (5 minutes, 0.5% neutral pH detergent, 40℃)
• rinse I (1 minute, ambient temperature water)• rinse II (1 minute,ambient temperature water)• disinfection (2.5 minutes, pure water 93℃)
2) Immediately after the cleaning cycle, interrupt the program and unload the samples.

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3) After cleaning in the WD, examine the instruments visually.
4) Carefully place the products in the disinfection basket. Fastening of the products is only permissible ifthey are freely moveable in the fixture. The products are not permitted to make contact with one another.
5) Using a suitable rinsing adaptor, connect the product lumina to the rinsing connections of the disinfector.
6) Start the program.
7) Remove the products from the disinfector and start the inspection (see section Inspection andmaintenance) after the program ends.
8) Wrap the products directly following disinfection and drying (see section Packaging and sterilization). If
necessary, repeat drying of the product in a clean place.

7. INSPECTION AND MAINTENANCE
If stains are still visible on the product after cleaning/disinfection, the entire cleaning/disinfection proceduremust be repeated. Products with visible damage, chip/flake loss, corrosion or bent out of shape must be
disposed of (no further use is permissible).

8. PACKAGING AND STERILIZATION
Do not exceed the maximum number of sterilization cycles.
Only cleaned and disinfected products are permitted to be sterilized. Prior to sterilization, the products need
to be placed in a suitable sterilization container:•Compliant with EN ISO 11607,•Resistant to 138°C, with adequate steam permeability,

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•Maintained on a regular basis.
If double, single-use sterilization packaging (double bag) is to be used, this must also comply with EN
ISO 11607 and be suitable for steam sterilization (temperature resistant to 138°C with adequate steam
permeability).
Use only the following listed steam sterilization procedures for sterilization; other sterilization procedures
are not permissible:•Fractional pre-vacuum procedure (steam sterilization with repetitive pre-vacuum.)•Steam sterilizer in accordance with EN 13060 or EN 285 validated in compliance with EN IS0 17665,•Maximum sterilization temperature 138°C,•Sterilization time at least 3 min. at 134°C (fractional pre-vacuum procedure),•Sterilization at 134°C for a maximum of 20 minutes is permissible.
The hot-air sterilization and radio-sterilization procedure may not be used (as it causes thedestruction of products).
The manufacturer assumes no responsibility for the use of other sterilization procedures (e.g.
ethylene oxide, formaldehyde and low temperature plasma sterilization). In such cases, pleaseobserve the respective valid standards (EN IS0 14937/ANSI AAMl IS0 14937 or the procedurespecific standard) and verify the suitability and effectiveness in principle of the procedure (ifnecessary, including investigations on sterilizing agent residue), taking into account the specificproduct geometry as part of the validation.

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9. SERVICE LIFE
The products have been designed for a large number of sterilization cycles. The materials used in their
manufacture were selected accordingly. However with every renewed preparation for use, thermal andchemical stresses will result in aging of the products.
If the number of permissible re-sterilization cycles is restricted, this will be pointed out in the product specific instructions.
The use of ultrasound baths and strong cleaning and disinfection fluids (alkaling pH > 9 or acid pH< 5) can reduce the life
span of products. The manufacturer accepts no liability in such cases.
The products may not be exposed to temperatures above 138°C.

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After service and Warranty Instruction

1 Period validity:
Two year’s free repair for the main unit, one year's free repair for the handpiece from the date ofpurchase. Lifetime maintenance.
2 Range of warranty:
Within the warranty period of validity, we are responsible for any troubles caused by quality
problems or products technique and structure.
3 The followings are beyond our warranty:
1) The damage caused by disobeying the operation instruction or lack of the needed condition.
2) The damage caused by unsuitable operation or disassembly without authorization.
3) The damage caused by unadvisable transportation or preservation.
4) There isn’t the seal of distributor or the warranty card isn’t filled in completed.

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