SAESHIN Traus SIP10 User manual

INSTRUCTION MANUAL
사용설명서
www.saeshin.com

SIP10
INTRODUCTION
USER GUIDELINES
PRODUCT FEATURES & ADVANTAGES
PRODUCT COMPONENTS
PART NAME OF CONTROL BOX
BUTTONS ON OPERATION PANEL
LCD WINDOW
BUTTONS ON THE FOOT CONTROLLER
CONNECTION OF EACH PART
OPERATION PROCESS
MAINTENANCE OF THE PRODUCT
ATTENTION
PRODUCT SPECIFICATION
ELECTROMAGNETIC COMPATIBILITY INFORMATION
WARRANTY
SYMBOL

INTRODUCTION
This product is medical device.
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 purpose>
• The TRAUS SIP10 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 BF applied part
• Classification according to the degree of protection against ingress of water as detailed in
the current edition of IEC 60529
- Control Box: IPX 0
- Foot Controller: IPX 8
• 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: Intermittent operation
• Applied part : Bur
<Use time>
• Loading time: 2 minutes
• Resting time: 15 minutes
<Operation & Storage condition>
2
Operating condition
Temperature (℃) 10~30
10~80
700~1,060
-20~60
10~90
500~1,060
Relative humidity (%)
Atmospheric pressure (hPa)
Temperature (℃)
Relative humidity (%)
Atmospheric pressure (hPa)
Transport and Storage condition

USER GUIDELINES
CAUTION
· Please pay attention to the use considering the patient’s safety first of all.
· Check condition of the product before use.
· Stop to use and inspect the product when an abnormal sign such as calescence, vibration or noise
occurs before or during operation.
· Please contact manufacturer if cannot find reason of problem, or cannot solve the problem.
· Prepare extra consumables before use for safety because blood or physiological saline might flow
into the head of angle handpiece.
· 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 handpiece right after use. Otherwise, the product could be damaged
due to coagulation of blood inside the product.
· The control box and foot controller are not steam sterilization objects
· The input power is available at AC 100-120 V / 220-240 V
(Check input voltage before connecting the AC power.)
· Dispose the irrigation tube as a medical waste after use.
· Contact manufacturer if incorrect display is on the screen.
· Do not drop or give a strong impact to the product.
· Do not give any damage to irrigation tube, it will not work normally due to the tube is broken or taken
off.
· Do not insert oil into BLDC motor. It will damage bearing or cause calescence.
· The product is designed to be used indoor, do not use outdoor.
· Do not use the product in humid or dusty environment.
· Use the regulated products and consumables by manufacturer. Otherwise there might be a risk of an
accident or failure.
· Replace the motor cord immediately when it is worn out or damaged to prevent electric shock for
user or patient.
· Specification and design of product can be changed to improve quality of product.
· User has responsibility to operate and maintain the product.
· The company did not sterilize the product. Please be sure to sterilize before operation.
(User sterilization)
· US Federal law restricts this device to sale by or on the order of a dentist.
4

WARNING
PROHIBITION
· 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 handpiece. In case of malfunction, dropping, or dropping in water, do not
use it and contact the manufacturer.
(It may cause vibration of bur, overheating, or damage of the bearings.)
· 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.
· Do not use damaged or broken power cord, plug, and outlet. It may cause fire and electric shock.
· When unplug the power cord, hold the plug and do not touch with wet hand.
Do not use loose power cord, it may cause electric shock and fire.
· Do not damage to power cord (do not bend too hard, do not put heavy objects on it). It may cause
electric shock and fire.
· Unauthorized modification and dismantling is prohibited.
· Do not use the solvent such as thinner or benzene for cleaning.
※ Be careful not to drop liquid on control box.
※ Do not wipe the control box (membrane) with wet fabric.
· Do not place the product near heat equipment, and do not put candles or cigarette on it.
· Please use a grounded plug. Contact to electrician or manufacturer to ask how to grounding.
· Be sure to use designated bur by ISO 1797.
· Follow the instruction 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 expert. If not, patient might get burn or damage by
improper use.
· Do not use the product to patient with cardiac pacemaker because the product may disturb the
performance of cardiac pacemaker.
· If patient is taking antibiotics, patient needs to consult with doctor before operation.
· Keep away from fire or heat when using spray containing flammable material.
· Manufacturer does not have any responsibility for defects or loss of property in cases below.
1. User did not follow the instruction manual to use the product.
2. Used the product in the place of unregulated wire condition.
3. Unauthorized person repaired or assembled the product.
4. Did not follow the instruction manual to keep the product.
6

<BLDC motor designed by SAESHIN’s own technology and know-how>
- Provide the optimized performance by BLDC motor and standard angle handpiece.
<Program Memory Function>
- Maximum 9 programmable memories for setting Speed, Gear Ratio, Torque, Rotating Direction and
Irrigation Pump.
<Automatic Overload Protection Function>
- The motor is automatically stopped and ‘Error’ sign display on screen when the load is higher than
Torque value.
- For releasing the overload function, release the foot controller.
<Realtime RPM, TORQUE View System>
- Actual RPM and Torque value are displayed on the screen. It makes user can do more delicate operation.
<Motor Auto-calibration Function>
- Motor auto-calibration function is that control box check the angle handpiece status to reconcile speed
and torque that user wants with angle handpiece for accurate and safe operation.
1. Set the program number at ‘0’. The program changes to calibration mode.
2. Push the foot controller to the end. The calibration starts and the display show the calibration process.
3. During normal operation, the calibration will be completed after 5~10 seconds with ‘-CAL-’ on the screen
and beep sounds.
4. When it is completed, Use the product.
<Ergonomic Foot Controller>
- Foot controller is designed ergonomically to control all the functions. And it provides high convenience.
<Optic Function - (option)>
- LED: 25,000 Lux
- Optic function is only operated by Optic angle handpieces (TRAUS CRB26LX, TRAUS CRB27LX,
TRAUS CRB46LN) and Optic micro motor(TRAUS MBP10SL).
PRODUCT FEATURES & ADVANTAGES
1:4
160,000rpm200,000rpm40,000rpm2,500rpm2,000rpm 1,480rpm
1:51:116:1 20:127:1
1,250rpm
32:1
620rpm
64:1
- RPM :
- Torque :
- Gear Ratio: 1:4, 1:5, 1:1, 16:1, 20:1, 27:1, 32:1, 64:1
- LED: 25,000 Lux
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)
- The function is set up when the product is released by manufacturer and Use the function when
user repair or change the product.
- Program 0 is the only for auto-calibration function, so the memory function or other setting value
does not work.
1:4
**N·cm**N·cm **N·cm 5~50N·cm 5~70N·cm 5~80N·cm
1:51:116:1 20:127:1
5~80N·cm
32:1
5~80N·cm
64:1
Basic Components TRAUS MBP10SX + Non-Optic Angle Handpiece : Except Optic Function
TRAUS MBP10SL + Optic Angle Handpiece : Optic FunctionOption
8

PRODUCT COMPONENTS
- Saline solution is not included in a set.
- Irrigation tube and Y-TUBE are disposable, Do not use them again.
10
1
8
2
9
3
10
4
11
5
12
6
13
7
14
15
16
1 9
2 10
3 11
4 12
5 13
6 14
7 15
8 16
No. No.
Component Component
HANGER
ANGLE HANDPIECE
FOOT CONTROLLER
BLDC MOTOR
CONTROL BOX
TUBE HOLDER
AC POWER CORD
TUBE CLAMP
MOTOR STAND
SPRAY NOZZLE
Y-Tube (Option)
IRRIGATION TUBE
FOOT POLE (Option)
INTERNAL SPRAY NOZZLE
MOTOR CAP For Autoclave
* Please check all components are included. (Some components may be changed by the manufacture.)
A-SLEEVE

PART NAME OF CONTROL BOX
Main Power
Switch
Fuse Box
Foot Controller
Connector
Main Power Socket
Motor Connector
Hanger Hole
Program Button
Memory Button
Optic Button
Speed Button
Torque Button
Irrigation Pump Button
Gear Ratio Button
Operation Direction Button
Irrigation Pump
12

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Irrigation Level Water Pump
Stage 0: 0 ml/min
Stage 1: abt. 40 ml/min ± 20%
Stage 2: abt. 55 ml/min ± 20%
Stage 3: abt. 70 ml/min ± 20%
Stage 4: abt. 90 ml/min ± 20%
0 1 2 3 4
BUTTONS ON THE OPERATION PANEL
Program Button:
Use for selecting the set program number. (+) button for 1 stage up and (-) button for
1 stage down.
Speed Button:
Use for setting the speed (RPM).
(+) button for 1 stage up and (-) button for 1 stage down. Keep pressing speed button to
change the stage rapidly.
* The setting range of speed is different from the gear ratio.
Torque Button:
Use for setting the torque according to the various use such as drilling or tapping.
(+) button for 5 N·cm up and (-) button for 5 N·cm down.
* The setting range of torque is different from the gear ratio.
Memory Button:
Keep pressing Memory button after completed setting. Then the condition is memorized
with beep sound.
Operation Direction Button:
Use for selecting the forward or reverse direction. The beep sound is heard during
rotation in reverse direction.
Irrigation Pump Button:
Use for setting the irrigation volume in 5 levels (From 0 to 90ml).
Optic Button:
When press the speed control pedal on the foot controller after operating the optic function,
LED is turned on at the angle and motor parts.
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 handpiece and Optic motor .
Gear Ratio Button:
Use for setting the gear ratio of the angle handpiece.
14

1
2
4
5
7
3
6
1. Irrigation Volume Display
: It shows the selected irrigation level. Level 0 is no volume and level 4 is maximum.
2. Program Number Display
: 9 programmable programs set from 1 to 9. And it shows program 1 at every power on.
3. Gear Ratio Display
: It shows the selected gear ratio number.
4. Operation Direction Display
: It shows the selected direction.
5. Speed 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 press foot controller to the end.
6. Optic Display (Optic Version)
: The optic function is working when bulb symbol display on the screen.
* Optic function is only operated by Optic angle handpiece and Optic motor.
* When press the speed control pedal on the foot controller after operating the optic function,
LED is turned on.
7. Torque Display
: It shows the initial setup torque value. The actual value is displayed in real-time during operation.
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 ‘Torque Limit’ on the screen and beep sound until user releases foot from the
foot controller.
- Impact to device and drop the device may cause breakage of LCD.
LCD WINDOW
16

- TRAUS FUS10
1. Program Button
: Use the button to select the program. 1 stage increased per each press. 1 stage decreases when press
this button above 3 seconds.
(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 to change the operation direction.
3. Irrigation Pump Button
: Use the button to select the irrigation volume. 1 stage increased per each press.
4. Speed Control Pedal
: The motor speed is controlled by pressing and releasing the foot controller.
3
2
1
4
BUTTONS ON THE FOOT CONTROLLER
18

1. Motor Connection
: Please insert the motor plug to the device correctly. (Place the arrow mark on top. See the picture below.)
- Make sure the power is off before connect each part.
(Otherwise, it might cause a malfunction.)
CONNECTION OF EACH PART
13 2
4
2. Foot Controller Connection
: Please insert the foot controller connector. Check the hole and pins of
foot controller connector are in place. Then screw the Connector Lock.
3. Power Cord Connection
: Insert the power cord into the main power inlet of the control box.
20
( O ) ( X )
Connector Lock

5. Hanger Setting
: Put the hanger into the hanger hole.
- If you do not use it for long period, please open pump roller cover.
Otherwise, the irrigation tube might be damaged.
4. Irrigation Tube Connection to Pump Roller

②Please place the irrigation tube correctly in the pump.
①Please press the button to open the pump cover.
③Please press the button to close the pump.
22

- If user does not remove the internal spray nozzle, and then presses the button or opens the lever
when bur replacement, the nozzle may be damaged.
6. Irrigation Tube Insertion
: Lock the irrigation stopper placed between the irrigation tube needle and pack,
then insert the irrigation tube needle to the pack in place with the pack downward.
7. Irrigation Nozzle Connection
: Insert the irrigation tube to the end of internal spray nozzle pipe and external spray nozzle pipe.
8. Tube Holder Connection
: Put the motor cord and irrigation tube together with holders. Insert the tube holder to the motor cord and
then put the irrigation tube for easy work.
- If pump is operating while the tube is bent or the water does not come out, the tube can be
broken or damaged.
Irrigation Tube Needle
Irrigation Stopper
Breather Needle
Tube Clamp
Y-Tube
Internal Spray Nozzle
External Spary Nozzle
Irrigation Tube
Tube Holder
Motor Cord
24

OPERATION PROCESS
Example)
(1) Turn the main switch on.
If the product is normal condition, it becomes standby mode with program 1 on the screen like below picture.
Program Setting
: First, select the program number then set Gear ratio, Speed, Torque, Rotating direction, Irrigation volume,
and Optic option, and press the memory button (above 2 seconds) to save the setting. (9 programs max.)
(2) Choose the program.
Press the button on the foot controller or button on the control box, the program changes
by 1 stage. Select the program that user want to use.
(Press the button on the foot controller for 3 seconds, program is decreased the 1 stage.)
The program returns to program 0 after program 9.
(3) Check the setting.
Check the display on LCD box to make sure the setting is correct.
(4) Start the operation.
The motor starts to rotate after press the speed control pedal. It runs at low speed with light press and
at high speed with heavy press by the set speed in max. If the irrigation mode is on, the pump operates
same as motor operation.
※Overload protection function.
: If the load exceeds the set torque during the operation, the overload protection function works not to
generate the extra torque.
(5) Stop the operation.
The operation is stopped when user takes foot off the speed control pedal.
(6) Change the operation direction.
Press the on the foot controller or button on the control box to reverse direction.
In reverse direction mode, the device will sound the beep, and it continues during the operation.
Press the button once more, it returns to forward direction.
- Change the rotary direction after stopping the motor. It causes damage of motor.
PRG 1
PRG 2
20 : 1
32 : 1
2,000RPM
1,250RPM
10 N·cm
15 N·cm
FWD
FWD
PMP : 4
PMP : 2
ON
OFF
Complete
Complete
26

Error and Remedy
When motor stops due to overload, disconnection or misuse, the error code explanation is below:
Fuse Replacement
Error Display Cause and Remedy
Err 01
Err 02
Err 03
Cause: Foot controller connection is wrong or Foot controller is
malfunctioning.
Remedy: Check the foot controller connection.
Press the speed control pedal on the foot controller.
If the remedy does not work, contact the manufacturer.
Cause: Motor connection is wrong or Motor is malfunctioning.
Remedy: Check the motor connection.
Press the speed control pedal on the foot controller.
If the remedy does not work, contact the manufacturer.
Cause: Running torque exceed preset torque during operation.
Remedy: Press the speed control pedal on the foot controller.
If the remedy does not work, contact the manufacturer.
Fuse Box
Check the fuse if the control box doesn’t work.
Contact the manufacturer to change the fuse.
28

1. Cleaning
■Angle Handpiece
①Rotate 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.
②Disconnect the angle handpiece to the motor.
③Remove contaminants on the angle handpiece using a nylon brush after soaking for 20 minutes
in Enzymatic Detergent.
④Rinse the angle handpiece using the tap water for 3 minutes to remove Enzymatic Detergent.
⑤Wash the angle handpiece for 10 minutes in the ultrasonic cleaner containing Enzymatic Detergent.
⑥Rinse the angle handpiece for 3 minutes in the ultrasonic cleaner containing purified water repeatedly
subjected 3 times. (Change the purified water each time.)
⑦Wipe using dust-absorbent after the product soaked in alcohol(70%) for 30 seconds.
■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.
MAINTENANCE OF THE PRODUCT
- Proteolytic enzyme detergents are recommended as Enzymatic Detergent.
- It is recommended to use ethanol for alcohol (70%).
30
2. Sterilization
Sterilization Product List
· Angle handpiece
· Motor (Assembling with motor cap)
Sterilization Method
①Dry the applicable products completely after cleaning.
②Put 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.
③Put the sterile bag in the sterilizer and sterilization for 4 minutes with 132℃, and let it dry for 30 minutes.
Temperature
132℃
Time
4 minutes
Dry
30 minutes
Sterilization
Moist heat sterilization
- This product is designed to withstand 250 times of re-sterilization process.
- This product recommends the moist heat sterilization (autoclave), other sterile methods are
not guaranteed the effectiveness.
- 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.
132

32
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.
- 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.)
Spray Nozzle Spray
Spray
Spray Nozzle
Optic Type
Non-Optic Type

1. Please read the notice below before operating the product.
1) Check the connection of every cords and correct operation when power-on.
2) Check the earth connection is safe.
3) Make sure to check the contact part to patient.
4) Check the voltage.
5) Check the sterile condition of autoclavable parts.
2. Please read the notice below during the product use.
1) Check the status of product and patient constantly during the surgery.
2) When product or patient has any problem, stop the operation in condition of patient’s safety or take
proper action.
3) Do not let patient to approach the product.
3. Please read the notice below after operating the product.
1) Do not put any physical pressure on the power cord, motor cord and foot controller cord.
4. Please read the notice below if the product is not used for a long period of time.
1) Turn off and unplug the product. Check the cord regularly and replace it if it has any damage.
2) Clean and sterilize.
3) Keep the product in proper place.
ATTENTION
34

Optic Type Non-optic Type
PRODUCT SPECIFICATION
Model Name TRAUS XIP10
AC 100-120V / 220-240V, 50/60 Hz
5A / 2A
48 VA
Max. 90 ㎖/ min ± 20%
Input
Fuse
Power Consumption
Maximum Irrigation Volume
Model Name TRAUS MBP10SL
Optic
Non-optic
40,000
Optic
40,000
Non-optic
BLDC type
TRAUS MBP10SX
RPM
Optic/Non-optic
Motor Type
1) Control Box
2) Motor
3) Angle Handpiece
4) Foot Controller
36
TRAUS
CRB26LX
TRAUS
CRB26XX
20 : 1
Optic Non-optic Optic Non-optic
32 : 1
TRAUS
CRB27LX
TRAUS
CRB27XX
TRAUS
CRB46LN
20 : 1
Optic Non-optic
TRAUS
CRB46NN
Model Name
Gear ratio
Optic/Non-optic
Bur Replacement Type
Bur Dimension
Coupling Dimension
Button Type
CA bur (Ø 2.35)
Standard dimension of dental handpiece (ISO 3964)
Model Name
IPX 8
TRAUS FUS10
Classification according to the
degree of protection against
ingress of water (IEC 60529)