SIP20

USER MANUAL

www.saeshin.com
 SIP20

Table of contents

INTRODUCTION

USER GUIDELINES

PRODUCT FEATURES & ADVANTAGE

PRODUCT COMPONENTS

PART NAME OF CONTROL BOX

BUTTONS ON THE OPERATION PANEL

LCD WINDOW

BUTTONS ON THE FOOT CONTROLLER

CONNECTION OF EACH PART

OPERATION PROCESS

MAINTENANCE OF THE PRODUCT

ATTENTION

PRODUCT SPECIFICATION

ELECTROMAGNETIC COMPATIBILTY INFORMATION

WARRANTY

SYMBOL
 INTRODUCTION

This product is medical device.

(Model name : SIP20)

Make sure to read this user manual before using.

This user manual is to assure proper installation and use.
Pay attention to read this user manual in order to making the best use of this product
and to assure the prolonged lifespan before using.
Specially, pay attention the contents with marks such as , and .

<User>
• Qualified Professional

<Intended use>
• SIP20 is intended for use in dental surgery, implantology, maxilla-facial surgery and
endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.
<Classification of Equipment>
• Type of protection against electric shock: ClassⅠ equipment

• Degree of protection against electric shock: Type B applied part

• Classification according to the degree of protection against ingress of water as detailed

in the current edition of IEC 60529
- Control Box: IPX0
- Foot Controller: IPX8
• Not suitable product in the atmosphere that exist flammable anesthetic mixture with air
or with oxygen.
• User sterile product (non-sterile product at shipment)
• Classification according to mode of operation: : Non-continuous operation
• Applied parts: Bur

<Use Time>
• Loading time: 2 minutes
• Resting time: 15 minutes

<Operation & Storage Condition>

Temperature (℃) 10~35

Operating Condition Relative Humidity (%) 10~80
Atmospheric Pressure (hPa) 700~1,060
Temperature (℃) -20~60
Transport and Storage Condition Relative Humidity (%) 10~90
Atmospheric Pressure (hPa) 500~1,060

1
 USER GUIDELINES

CAUTION

· Please pay attention when using to consider the patient’s safety most importantly.

· Check the condition of the product before use.

· Stop using and inspect the product when an abnormal sign occurs such as calescence, vibration
or noise before or during operation.

· Please contact manufacturer if problem cannot be solved.

· Prepare extra consumables before use for safety.

· Change or insert bur after the motor is completely stopped. Otherwise, inside of the angle
could be damaged by bur, and it could cause an accident.

· Please sterilize and lubricate the angle handpiece right after use. Otherwise, it could be damaged
due to coagulation of blood inside the product.

· The control box and foot controller are a not steam sterilization objects.

· The input power is available at AC 100-120V / 220-240V.

(Check input voltage before connecting the AC power.)

· Dispose the irrigation tube as a medical waste after use.

· Contact manufacturer if an incorrect display appears on the screen.

· Do not drop or bang the product.

· Do not damage the irrigation tube, as it will not work properly due when the tube is broke
or dislodges.

· Do not insert oil into the motor. It will damage bearing or cause calescence.

· The product is designed to be used indoors; do not use outdoors.

· Do not use the product in a humid or dusty environment.

· Use only regulated products and consumables by the manufacturer. Otherwise,there could
be a risk of an accident or failure.
· Replace the cords immediately when it is worn-out or damaged to prevent electric shock to the user
or patient.

· Manufacturer may change specification and design of this product in order to improve the quality.

· User has responsibility to operate and maintain this product.

· The company did not sterilize the product. Please make sure to sterilize before operation.
(User sterilization)

· US Federal law restricts this device to sales by or on the order of a dentist.

· Do not sterilize with different methods other than moist heat sterilization. It may cause damage
to the product

2
 WARNING

· Please watch old person, children, or disabled person near the place that the product is installed.
If so, do not let them alone.
· Do not drop or damage the angle handpiece. In case of malfunction, dropping or falling in water,
do not use it and contact the manufacturer.
· The equipment is automatically stopped when the machine load is higher than Torque value.
· Do not damage or drop the LCD part of the control box.
· Portable and mobile Radio Frequency communications equipment can affect the product.
Do not use Radio Frequency equipment outskirts for the product.
· The system may present a possibility of malfunction when used in the presence of an electromagnetic
interference wave. Do not install the system in the vicinity of the device which emits magnetic waves.
Turn off the power switch of the Control box when an ultrasonic oscillation device or an electrode
knife is located in the vicinity is used.
· For safety, install the control box in a place where the power cord can be easily removed.
(It is possible to disconnect the control box from the power source by removing the power cord.)

PROHIBITIED

· Do not use a damaged or broken power cord, plug, or outlet. It may cause fire and/or electric shock.
· When unplugging the power cord, do not touch cord with wet hand.
· Do not damage the power cord (do not bend too hard, or put heavy objects on it). That may cause
electric shock and/or fire.
· Unauthorized modification and dismantling is prohibited.
· Do not use a solvent such as thinner or benzene for cleaning.
※ Please use an absorbent or alcohol to wipe the controller box. Do not wipe with wet cloth.
※ Be careful not to drop liquid on control box.
· Do not place the product near any heated equipment and do not put candles or cigarettes on it.
· Use only a grounded outlet. Please contact electrical technician or manufacturer regarding the
ground connection.
· Be sure to use designated bur by ISO 1797.
· Follow the user manual by manufacturer of bur to use bur.
· Keep the recommended speed limit by manufacturer of bur to use bur. If exceed the speed limit,
it might cause an accident.
· The product must be used by specialist or dentist. If not, patient might get hurt from improper use.
· If patient is taking antibiotics, patient needs to consult with doctor before operation.
· Keep product away from spray containing flammable material.
· Manufacturer does not have any responsibility for defects or loss to property in the following cases:
1. User did not follow the user manual when using the product.
2. Used the product in a place of unregulated wire condition.
3. Unauthorized person repaired the product.
4. Did not follow the user manual for this product.
· Do not use on the following patients.
1. Those with medical complications or allergies.
2. Those who have pre-existing conditions. (E.g. Cardiac, Pulmonary, Renal disturbance or
High blood pressure)
3. Those who are pregnant or lactating.
4. Patients with cardiac pacemakers and infants.
3
 PRODUCT FEATURES & ADVANTAGES

<BLDC motor designed by SAESHIN’s own technology and know-how>

- Provide the optimized performance by BLDC motor and standard angle handpiece.
- RPM :

Gear Ratio 1:1 1:2 1:5 16:1 20:1 32:1

RPM 1,000 ~ 2,000 ~ 5,000 ~ 30 ~ 15 ~ 10 ~

40,000 rpm 80,000 rpm 200,000 rpm 2,500 rpm 2,000 rpm 1,250 rpm

- The free-running speed of the handpiece shall be in accordance with the manufacturer’s instructions
at a tolerance of ±10 % as specified. (Refer to ISO 14457)
- Torque :

Gear Ratio 1:1 1:2 1:5 16:1 20:1 32:1

Torque -.- -.- -.- 5 ~ 50 N·cm 5 ~ 80 N·cm 5 ~ 80 N·cm

- Gear Ratio: 1:1, 1:2, 1:5, 16:1, 20:1, 32:1

<Program Memory Function>

- 9 programmable memories for setting Gear Ratio, RPM, Torque, Rotating Direction, Irrigation Pump, Optic.

<Automatic Overload Protection Function>

- If the actual loading gets higher than the preset torque value, the motor stops automatically, and the error
code is displayed on the screen.
- To release the overload function, release the foot controller.

<Realtime RPM View System>

- Actual RPM is displayed on the screen.

<Motor Auto-Calibration Function>

- Motor auto-calibration function is that controller check the angle handpiece status to reconcile speed and
torque that user wants with angle handpiece for accurate and safe operation.

- The function is set up when the product is released by manufacturer.

And use the function when user repair or change the product.

<Beep Sound Function>

- When using reverse direction, ring the beep sound for protecting user confusion.

<Ergonomic Foot Controller>

- The ergonomically designed Foot Controller with main functions can be used during any surgery for user’s convenience.

<Setting with SETUP Mode>

- Auto Calibration, Sound Volume Control and Program Reset are available.

<Optic Function – (Optional)>

Basic Components MBP10SX + Non-Optic Angle Handpiece : Except Optic Function

Optional MBP10SL + Optic Angle Handpiece : Optic Function

- LED: 25,000 lx
- Optic Function is only operated by the optic angle handpieces(CRB26LX, CRB27LX, CRB46LN)
and optic micro motor (MBP10SL).

4
 PRODUCT COMPONENTS

* Please check all components are included. (Some components may be changed by the manufacture.)

① ⑧

② ⑨

③ ⑩

④ ⑪

⑤ ⑫

⑥ ⑬

⑦ ⑭

No. Component No. Component

1 Control Box 8 Internal Spray Nozzle (Optional)

2 Angle Handpiece 9 Motor Cap (For Sterilization of motor)

3 BLDC Motor (Optional) 10 Tube Holder

4 Foot Controller 11 Tube Clamp

5 Motor Stand 12 AC Power Cord

6 Hanger 13 Spray Nozzle

7 A-Sleeve 14

- Saline solution is not included in a set.

- Irrigation tube and Y-Tube are disposable, Do not use them again.

5
 PART NAME OF CONTROL BOX

Hanger Hole

Irrigation Pump

Motor Connector

LCD Display

Main Power Socket

Main Power Switch

Fuse Box Foot Controller Connector

Gear Ratio Button Menu Button

Rotation Direction
Button
Control Button
Irrigation Button

Optic Button OK Button

6
BUTTONS ON THE OPERATION PANEL

Gear Ratio Button

: This is used for selecting the gear ratio of the handpiece used during the procedure.
> 1:1 -> 1:2 -> 1:5 -> 16:1 -> 20:1 -> 32:1

Rotation Direction Select Button

: This is used for selecting the direction of rotation (Forward, Reverse). During reverse
operation, it beeps continuously.

Irrigation Button
: This is used for selecting the irrigation volume.
It can control stage 0 to 5 (Max. 90 mℓ/min ± 20%).

Stage Volume
Stage 0: STOP
0 1 2 3 4 5
Stage 1: 35 ml/min ± 25%
Stage 2: 50 ml/min ± 25%
Stage 3: 65 ml/min ± 20%
Stage 4: 80 ml/min ± 20%
Stage 5: 90 ml/min ± 20%

Optic Button
: When press the speed control pedal on the foot controller after operating the optic
function, LED is turned on at the angle head part. Release the speed control pedal, turn off
the LED after 3 seconds. Turn off the optic function, LED is not operated regardless
pressing the speed control pedal. Optic function is only operated by Optic angle and Optic
motor.

Menu Button
: This is used for selecting the desired menu.
The right menu is selected sequentially per each press the button.

Control Button
: This is used for selecting the program number, SETUP menu and adjusting the rpm, torque.
※ The setting range of rpm and torque are different from gear ratio.

OK Button
: This is used for completing the setting.

7
 LCD WINDOW

11 9

1 20:1 5
15 RPM
SETUP

2 FWD
RPM 6

80 N.cm
3 N.CM
Torque 7

4 Set
Set up
8
ON

12 10

1. Gear Ratio Display

: It shows current set of gear ratio.

2. Rotation Direction Display

: It shows the selected direction.

3. Irrigation Volume Display

: It shows selected irrigation stage. The stage is 0 to 5 (Stage 0 = No volume / stage 5 = Maximum volume).
Number of Water drop shows the volume stage.

4. Optic Display
: The optic function is working when bulb symbol display on the screen.
* Optic function is only operated with optic angle handpiece.
* When press the speed control pedal on the foot controller after operating the optic function, LED is turned on.

5. Program Number Display

: It shows current set of program number. It display Program 1 to 9 and can save 9 programs. After restart
the device, it displays program number 1.

6. RPM Menu Display

: When the corresponding menu is selected, the RPM can be adjusted using the and buttons.

7. Torque Menu Display

: When the corresponding menu is selected, the torque can be adjusted using the and buttons.

8. SETUP Menu Display

: When the corresponding menu is selected, it can be move to setup menu using the button.

9. RPM Display
: It shows the initial setup RPM when it is on standby. The actual value is displayed in real-time during operation.
The number is same as set RPM level when pressing foot controller to the end.

10. Torque Display

: It shows the setup torque value. If an actual load is higher than set torque value, the set torque value is
on the screen and the motor is stopped automatically with ‘E3’ on the screen and beep sound.

11. Foot Controller Gauge Display

: The gauge indicates the degree to which the foot controller is pressed during operation.

12. Torque Gauge Display

: The gauge indicates the actual load value during operation.

- Be careful that the LCD on the control box could be damaged by impacting or dropping.

8
 BUTTONS ON THE FOOT CONTROLLER

1. Program Button
: Use the button to select the program. 1 stage increases per each press. 1 stage decreases when press
this button above 1 second. (Program decrease function is not operated continuously. If you want to
decrease program over the 2 stage, press the button after releasing the button.)

2. Operation Direction Button

: Use the button for selecting the operation direction. Press the button, change the rotary direction.

3. Irrigation Pump Button

: Use the button for selecting the irrigation volume. 1 stage increases per each press.
Press the button above 1 second, set the 0 stage (stop condition).

4. Speed Control Pedal

: The motor speed is controlled by pressing and releasing the foot controller.

9
 CONNECTION OF EACH PART
⑤

20:1

15 RPM
SETUP

RPM
FWD

80 N.cm
N.CM
Torque

Set
Set up
ON

① ④ ③②
- When connecting the motor, foot controller and power cord,
please make sure the power is off.
(Otherwise, it might cause a malfunction.)

1. Motor Connection
: Insert the motor connector. Check if the holes and pins of motor connector are lined-up.
(Place the arrow mark on top. See the picture below.)

(O) (X)

2. Foot Controller Connection

: Insert the foot controller connector. Check if the holes and pins of foot controller connector are lined-up.
Then screw the connector lock.

connector lock.

3. Power Cord Connection

: Insert the power cord into the main power inlet of the control box.

10
4. Irrigation Tube Connection

A B

handpiece connection Saline connection

Open the pump roller cover. Insert the irrigation tube correctly.

B-1 C

Locate the Irrigation tube correctly when insert Close the pump roller cover.
the irrigation tube. Otherwise, (You must close the cover and use
Irrigation cannot be smoothly. it as your fingers may get stuck.)

C-1 D

Make sure the irrigation tube is located correctly Make sure the pump roller cover is correctly close.
when close the pump roller cover.

- When it is not in use for long term, open the pump cover.
Irrigation tube might change its shape and cause a malfunction.

11
 5. Hanger Setting
: Put the hanger into the hanger hole.

6. Irrigation Tube Insertion

: Insert the irrigation tube needle into the bottle and place with the bottle downward.
Lock the irrigation stopper and put it between the irrigation tube needle and bottle.

Irrigation tube needle

Breather needle

lrrigation Stopper

- If the pump is in operation mode but water does not come out of the handpiece,
the tube may be broken or damaged.

7. Irrigation Nozzle Connection

: The internal and external irrigation are available by the Y-tube. Connect the accessories
as in the picture according to the bur using and the surgery type.

Y-tube
Internal spray nozzle

Tube clamp

External spray nozzle

- If the user did not remove the internal spray nozzle and pressed the button or open the lever
when replacing the nozzle may get damaged.

8. Tube holder connection

: Put the motor cord and irrigation tube together with the tube holders. Insert the tube holder
to the motor cord and then insert the irrigation tube in order to create a better working condition.

lrrigation tube

Tube holder

Motor cord

12
9. Angle Handpiece Connection

Handpiece & Motor connection Handpiece & Motor disconnection

connection disconnection

Handpiece Motor Handpiece Motor

1) Connect : Insert the groove (non-optic) or key (optic) of the angle handpiece into the pin (non-optic)
or groove (optic) position of the motor handpiece

2) Disconnect : Hold the motor handpiece and pull the angle handpiece.

10. Dental bur Connection

Connecting the bur Disconnecting the bur

Head Button Head Button

1) Connecting the bur

① Insert the bur to the angle handpiece.
② Insert certainly the bur while pushing the head button on angle handpiece.
③ Release the button
④Pull out the bur to check it

2) Disconnecting the bur

①Pull out the bur while pushing the head button on angle handpiece.

13
 OPERATION PROCESS

1. Press the Gear Ratio Button ( ) to select the gear ratio to use.

2. Press the Rotation Direction Button ( ) on the control box or Rotation Direction Button ( )

on the foot controller to select the rotation direction. Rotation direction is forward and reverse.
During the reverse operation, it beeps continuously.
(beeps let the user know the operation direction.)

3. Press the Irrigation Button ( ) on the control box or Irrigation Button ( ) on the foot

controller to select the irrigation volume. Irrigation volume per each stage refers to the below.

Irrigation Stop 35 mℓ/min ± 25% 50 mℓ/min ± 25% 65 mℓ/min ± 20% 80 mℓ/min ± 20% 90 mℓ/min ± 20%

4. Press the Menu Button ( ) to go to the RPM Menu. Set the desired RPM value using and

button.

Keep pressing speed button to change rapidly. The setting range of rpm is different from gear ratio.

Gear Ratio 1:1 1:2 1:5 16:1 20:1 32:1

1,000 ~ 2,000 ~ 5,000 ~ 30 ~ 15 ~ 10 ~
RPM
40,000 rpm 80,000 rpm 200,000 rpm 2,500 rpm 2,000 rpm 1,250 rpm

5. Press the Menu Button ( ) to go to the Torque Menu. Set the desired torque value using

and button.

The setting range of torque is different from gear ratio.

Gear Ratio 1:1 1:2 1:5 16:1 20:1 32:1

Torque -.- -.- -.- 5~50 N·cm 5~80 N·cm 5~80 N·cm

6. Press the Optic Button ( ) to use optic function.

7. Use it by pressing the speed control pedal on the foot controller.

8. After the operation is finished, remove the foot from the speed control pedal, stop the product,
and turn off the product

- Before operating product, please check the connection of irrigation tube on the angle
handpiece. If irrigation tube isn’t connected and delivered to bur, there is risk of tissue necrosis
or bone damage. Because of the frictional heat between bur and operation site.
(Installation method of Irrigation tube: Refer to the connection of each part.)

■ Program Setting

1. Press the Menu Button ( ) to go to program number menu.

2. Press the Control Button ( , ) to select the desired program number.

3. After setting the desired value by referring to the operation method, keep pressing OK Button ( )
for 3 seconds.

4. The ‘SAVING’ is displayed on LCD, program is memorized with beep sound.

14
Other Function (SETUP)

Press the Menu Button ( ) to go to SETUP Menu and press the OK Button. ( )

Press the Control Button ( , ) to the desired item.

Press the OK Button ( ) in SETUP to save and return to main.

1. AUTO CALIBRATION

After connecting the angle to the motor, hold the motor by hand tightly. Step the foot controller fully in order
to start the calibration.
Calibration will be completed with beep sound and display “Calibration Completed”.
- The calibration function sets up for all products from the first delivery or purchasing
by the manufacturer. It is recommended to calibrate the motor before using when the motor is
replaced or repaired.

2. Sound Volume Control

Number of icon bar indicates loudness level of sound.

4 stages, set the sound volume by pressing or button.

Press the OK Button ( ) to complete the setting after setting the level of volume.

- Beep sound shuts off in mute mode.

3. Program Reset

By using , button, determine the initialization.

Choose “NO” with button, the initialization will cancel.

Choose “YES” with button, the initialization will start.

Screen will off for 5-10 sec. And show reset screen with beep sound and message “RESET Completed”.
Then save and return to main. 15
 ■ Error and Remedy
: In case of stopping handpiece by not working & using error, each error code may be shown below.

Error code Cause & Remedy

Warning Cause : The foot controller connection is not proper or the foot controller is defective.

E1
Foot Check!
Remedy : Make sure that the foot controller is properly connected.
Contact the manufacturer if the remedies do not activated.

Warning
Cause : The motor connection is not proper or the motor is defective.

E2
Motor Check!
Remedy : Make sure that motor properly connected.
Contact the manufacturer if the remedies do not activated.

Warning
Cause : Torque is overloaded than the setting values during the surgery.

E3
Torque Limit!
Remedy : Press the speed control pedal to release the error.
Contact the manufacturer if the remedies do not activated.

■ Fuse replacement

- Check the fuse if the control box doesn’t work.

Fuse Box - If necessary contact the manufacturer.

16
 MAINTENANCE OF THE PRODUCT

1. Cleaning
■ Angle Handpeice
① Rotate the head in a tap water about 10 seconds with maximum speed to remove the remains
(blood, physiologic saline solution, etc.) and rinse.
※ Do not put tap water in the motor.
② Disconnect the angle handpiece to the motor.
③ Remove contaminants on the angle handpiece using a nylon brush after soaking for 20 minutes
in Enzymatic Detergent.
④ Rinse the angle handpiece using the tap water for 3 minutes to remove Enzymatic Detergent.
⑤ Wash the angle handpiece for 10 minutes in the ultrasonic cleaner containing Enzymatic Detergent.
⑥ Rinse the angle handpiece for 3 minutes in the ultrasonic cleaner containing purified water repeatedly
subjected 3 times. (Change the purified water each time.)
⑦ Wipe using dust-absorbent after the product soaked in alcohol(70%) for 30 seconds.
⑧ Please visually inspect the angle handpiece in a bright place after cleaning. If the angle handpiece is
still soiled after cleaning, the cleaning process must be repeated .
■ Control Box, Foot Controller , Motor
Wipe the surface of motor with alcohol swab or paper towel after removing the dirt.
※ Pay attention to not enter the water into the motor.
- Proteolytic enzyme detergents are recommended as Enzymatic Detergent.
- It is recommended to use ethanol for alcohol (70%).
- If the device is determined not to be visually clean at the end of the cleaning step, the user
should either repeat the relevant previous cleaning steps or safely dispose of the device,
so that a visibly soiled device is not used again.

2. Sterilization
■ Sterilization Product List
① Angle handpiece
② Motor (Assembling with motor cap)
■ Sterilization Method
① Dry the applicable products completely.
② Put the applicable products in a sterile bag and seal tightly.
※ Make sure to assemble the motor cap for autoclave on the motor.
※ Do not disassemble the motor and motor cord when sterilizing.
③ Put the sterile bag in the sterilizer and sterilization for 4 minutes with 132℃, and let it dry for 30 minutes.

Sterilization Temperature Time Dry

Moist heat sterilization 132℃ 4 minutes 30 minutes

* Maximum sterilization number is 250 times.

* Moist steam sterilization only. Otherwise the products might be damaged.
* Make sure to use the sterilization bag and seal tightly.
* Make sure to dry the applicable products before sterilization.
* Motor could be damaged in sterilization because of the moisture inflow or else,
so should be careful to handle it.
* Sterilizing the angle handpiece with blood or other remains may cause the breakage
of the angle handpiece
Therefore, it is necessary to clean the angle handpiece before sterilization
* Irrigation tube and Y-tube are disposable. Do not re-use
* Keep dry a connector and socket of the control box.
* Before using, dry the product completely.

17
 3. Lubrication
Lubrication Product List
Angle handpiece
Lubrication method
Insert the nozzle to motor assembly part(the end part of angle) and spray lubricant 2~3 seconds.

Optic type

Spray Nozzle Spray

Non-optic type

Spray Nozzle Spray

- Do not insert the oil into the motor. It damages the bearing or causes fever.
- If the continuous operation, please put the oil every an hour.
- When lubrication, please hold the angle handpiece firmly because the angle handpiece can go out
by the spray pressure.
- Caution: Lubrication spray present combustible hazard.
- Use FDA approved lubricant. (K052700 equivalent lubricant is available.)

ATTENTION
1. Please read the notice below before operating the product.
① Check the connection of all cords and correct operation when powering-on.
② Check if the ground connection is safe.
③ Make sure to check any contact part to patient.
④ Check the voltage.
⑤ Check the sterile condition of autoclavable parts. If the packaging of the sterilized product is damaged,
discard the product.
- Irrigation Tube
- Y-Tube
- A-sleeve

2. Please read the notice below during the product use.

① Constantly check the status of the product and patient during surgery.
② When product or patient has any problem, stop the operation for the patient’s safety and
take the proper action.
③ Do not let patient approach or touch the product.

3. Please read the notice below after operating the product.

① Do not put any physical pressure on the all cords.

4. When the products are not using for a long term, please be advised to the followings.
① Turn off the power and unplug the cord. Check the cord regularly and replace it when
it is damaged.
② Clean and sterilize.
③ Keep the products in the recommended condition.

18
 PRODUCT SPECIFICATION

1) Control Box

Model Name BIP20

Input AC 220-240V
Fuse 2A
Frequency 50/60 Hz
Output 48VA
Irrigation Volume Max. 90 ㎖ / min ± 20%

2) Motor
Optic

Model Name MBP10SL MBP10SX

RPM 40,000 40,000

Non-optic Optic/Non-optic Optic Non-optic

Motor Type BLDC Type

3) Angle Handpiece

Optic Type Non-optic Type

Model Name CRB26LX CRB26XX CRB27LX CRB27XX CRB46LN CRB46NN

Gear ratio 20 : 1 32 : 1 20 : 1

Optic/Non-optic Optic Non-optic Optic Non-optic Optic Non-optic

Bur Replacement Type Button Type

Bur Dimension CA bur (Ø 2.35)

Coupling Dimension Standard dimension of dental handpiece (ISO 3964)

4) Foot Controller

Model Name FUS10

Classification according to the

degree of protection against ingress IPX8
of water (IEC 60529)

19
 ELECTROMAGNETIC COMPATIBILITY INFORMATION

In IEC/EN 60601-1-2 4th edition. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. This equipment generate, use and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause harmful interference
to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to other devices, which can be determined
by turning the equipment off and on, the user is encouraged to try to correct the interference by one
or more of the following measures:
- Reorient or relocate the receiving device.
- Increase the separation between the equipment.
- Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected.
- Consult the manufacturer or filed service technician for help.

Electromagnetic Emissions

The SIP20 is intended for use in the electromagnetic environment specified below. The customer
or the user of the SIP20 should assure that is used in such an environment.

Emission test Compliance Electromagnetic environment - guide

SIP20 uses RF energy for internal operation.

RF emission – CISPR 11
Group 1 Therefore, its radiofrequency emissions are very low and
EN 55011
are not likely to cause any interference in nearby equipment.

RF emission – CISPR 11
Class A
EN 55011
SIP20 covers devices for usage in all establishments
other than domestic and that are not directly connected to
Harmonic emission – a low voltage power supply network, which supplies
IEC 61000-3-2 Class A domestic environment.
EN 61000-3-2

This is a class A product. In a domestic environment this

Voltage fluctuations
product may cause radio interference in which case the
Flicker emission –
Compliance user may be required to take adequate measures.
IEC 61000-3-3
EN 61000-3-3

20
 Electromagnetic Immunity

The SIP20 is intended for use in the electromagnetic environment specified below. The customer

or the user of the SIP20 should assure that is used in such an environment.

IEC 60601
Emission test Compliance level Electromagnetic environment – guidance
test level

Electrostatic discharge (ESD) Floors should be wood, concrete or ceramic tile.

±8kV contact ±8kV contact
IEC 61000-4-2 If floors are covered with synthetic material,
±15kV air ±15kV air
EN 61000-4-2 the relative humidity should be at least 30%.

Electrical fast transients ±2kV for power ±2kV for power

Mains power quality should be that of a typical
IEC 61000-4-4 supply lines ±1kV supply lines ±1kV for
commercial or hospital environment.
EN 61000-4-4 for input/output lines input/output lines

Surges ±1kV differential ±1kV differential

Mains power quality should be that of a typical
IEC 61000-4-5 mode ±2kV mode ±2kV
commercial or hospital environment.
EN 61000-4-5 common mode common mode

Voltage dips, Mains power quality should be that of a typical

0 % UT for 0.5 cycle 0 % UT for 0.5 cycle
short interruptions and commercial or hospital environment. If the user
at 8 Φ angles at 8 Φ angles
voltage variations requires continued operation during power mains
0% UT for 1 cycle 0% UT for 1 cycle
IEC 61000-4-11 interruptions, it is recommended that
70 % UT for 25/30 cycles 70 % UT for 25/30 cycles
EN 61000-4-11 the SIP20 got power from an uninterruptible
0 % UT for 250/300 cycle 0 % UT for 250/300 cycle
power supply or battery.

Power frequency (50/60Hz)

Power frequency magnetic fields should be at levels
magnetic field
30 A/m 30 A/m characteristic of a typical location in a typical
IEC 61000-4-8
commercial or hospital environment.
EN 61000-4-8

NOTE: UT is the a.c. mains voltage prior to application of the test level.

21
 Electromagnetic Immunity

The SIP20 is intended for use in the electromagnetic environment specified below. The customer or the user of

the SIP20 should assure that is used in such an environment.

IEC 60601
Immunity test Compliance level Electromagnetic environment – guidance
test level

3 Vrms 3 Vrms Portable and mobile RF communications equipment

Conducted RF 150 kHz to 80 MHz 150 kHz to 80 MHz should be used no closer to any part of the SIP20

IEC 61000-4-6 6 Vrms 6 Vrms including cables, than the recommended separation

EN 61000-4-6 In ISM bands from In ISM bands from distance calculated from the equation applicable to

150 kHz to 80 MHz 150 kHz to 80 MHz the frequency of the transmitter.

Recommended separation distance

d = 1.2 √P
d = 1.2 √P 80MHz to 800MHz
d = 2.3 √P 800MHz to 2.7GHz

Radiated RF Where ‘P’ is the maximum output power rating of the transmitter in watt (W)
3 V/m 3 V/m according to the transmitter manufacturer
IEC 61000-4-3
80 MHz to 2.7 GHz 80 MHz to 2.7 GHz ‘d’ is the recommended separation distance (m).
EN 61000-4-3

The electromagnetic field strength of fixed radiofrequency emitters, which is

determined by an electromagnetic environment measurement (a), must be
less than the compliance level in each frequency range (b).

Interference may occur near equipment marked with the symbol below:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These specifications may not be applicable in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,

objects and persons.

(a): The electromagnetic field strength of fixed radiofrequency emitters, such as base stations for mobile telephones (cellular / cordless), mobile radio,

AM/FM radio broadcasts and TV broadcasts cannot be determined exactly by theory.

To assess the electromagnetic environment due to fixed radiofrequency emitters, an electromagnetic environment measurement must be made.

If the measured radiofrequency field strength in the immediate environment where the product is used exceeds the compliance level specified above,

the performance of the product must be tested to verify whether it conforms to the specification. If abnormal performance is observed, additional

measures may be necessary, such as reorienting or relocating the product.

(b): In the 150 kHz to 80 MHz frequency range, the electromagnetic field strengths must be less than 3V/m.

22
 Recommended separation distances between portable and mobile RF
communications equipment and the SIP20

The SIP20 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

The customer or the user of the SIP20 can help prevent electromagnetic interference by maintaining a minimum

distance between portable and mobile RF communications equipment (transmitters) and the SIP20 as recommended

below, according to the maximum output power of the communications equipment

Rated maximum output Separation distance according to frequency of transmitter (m)

Power of transmitter
150 kHz ~ 80 MHz 80 MHz ~ 800 MHz 800 MHz ~ 2.7 GHz
(W) d = 1.2 √P d = 1.2 √P d = 2.3 √P

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 above, the recommended separation distance ‘d’ in meters (m) can
be estimated using the equation applicable 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 higher frequency range applies.
Note 2: These specifications may not be applicable in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and persons.

Cables and accessories Maximum length Shield Complies with

RF emissions, CISPR11 Class A / Group 1

IEC 61000-3-2
Harmonic emissions
EN 61000-3-2

IEC 61000-3-3
Voltage fluctuations / flicker emissions
EN 61000-3-3

IEC 61000-4-2
Electrostatic discharge (ESD)
EN 61000-4-2

Piezo handpiece cord 1.7 M Unshielded IEC 61000-4-4

Electrical fast transient / burst
EN 61000-4-4

IEC 61000-4-5
Foot controller cord 1.7 M Unshielded Surge
EN 61000-4-5

Voltage dips, short interruptions

AC power cord 1.7 M Unshielded IEC 61000-4-11
and voltage variations on
EN 61000-4-11
power supply input lines

Power frequency (50/60Hz) IEC 61000-4-8

magnetic field EN 61000-4-8

IEC 61000-4-6
Conducted RF
EN 61000-4-6

IEC 61000-4-3
Radiated RF
EN 61000-4-3

Description of BASIC SAFETY and ESSENTIAL PERFORMANCE

The SUS20 is intended for use in the electromagnetic environment specified above.
The following essential performance of SUS20 should be running in such an environment.
1) Irrigation volume should be over the 35 ㎖/min ±20% during handpiece is operated.
23
 WARRANTY
SAESHIN guarantees out product for 1 year from invoice date, and product warranty means that SAESHIN has
responsibility of defective material or operation failure. The product warranty does not cover user’s misuse,
wrong installation, inappropriate maintenance and repair, and normal wear of consumables such as bearings,
spindle, gear, and rotator. To check the warranty requires the operating condition, environment information,
serial number of the product and stamped invoice. The warranty will be performed as repairs or exchanges by
manufacturer’s judgement and analysis of product.

Exception of warranty
User’s misuse or improper use and treatment
Use the product with incorrect input voltage (AC voltage)
Drop the device during setting, moving, using
Use the not recommended consumables or accessories
Malfunction after repairing the product at the not recommended repair shop
Normal wear of the consumables such as ball bearing, gear, chuck, spindle case assy, rotator etc.
Faulty by Act of God

Foreign Language Manual Support

This manual is offered in Korean and English. If other languages are needed,
please contact Saeshin for the manual.
1) The translated manual will be supplied by manufacturer on demand.
2) Saeshin will send the translated manual with an English manual to the import company to review
the translated manual.
3) After getting feedback from the import company, Saeshin will offer a final version of the manual.

24
SYMBOL

Menu Button
Gear Ratio Button

Rotation Direction Button Control Button

Irrigation Button OK Button

Optic Button Consult Instruction For Use

Manufacturer General Caution Sign

EC Representative General Warning Sign

SN Serial Number General Prohibition Sign

132 Autoclave Alternating Current

Power On
Fuse (Main power switch)

Degree of protection against Power Off

electric shock - Type B (Main power switch)

This product should not be mixed with

NON Non sterile
other commercial waste for disposal STERILE

Caution hand injury CE Marking

1639
25
 This product is the medical device. 1639
MERIDIUS MEDICAL EUROPE LIMITED
Unit 3D, North Point House North point
Business Park New Mallow Road CORK,
T23AT2P, Ireland
Tel. 82-53-587-2341 / Fax. 82-53-580-0999
+353 212066448
대구광역시 달성군 다사읍 세천로 1길 52
(성서5차산업단지)
Tel. 053-587-2345 / Fax. 053-580-0918

SOM-S048S-E Rev.3 2023-01-30

www.saeshin.com / traus@saeshin.com