MicroNX ELEC ENGINE SE-170C User manual

Dental Engine for Implant Surgery / ISE-170C, ISE-170L
INSTRUCTIONS FOR USE

Symbols
Federal law restricts this device to sale by or the order of a dentist
Catalogue number
Serial number
Manufacturer
Authorized representative in the European Community
Date of manufactured
BF type applied part
Alternating current
Keep dry
Caution
Consult Instruction for use
Do not dispose of with domestic waste
Water proof grade
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IPX1

Contents
Chapter 1. Overview
Chapter 2. Safety
Chapter 3. Product Description
Chapter 4. Installation
Chapter 5. Operation
Chapter 6. Maintenance
Chapter 7. Trouble Shootings
Chapter 8. Accessories and Service
Chapter 9. Electromagnetic Compatibility
Chapter 10. Disposal
3
4
6
11
14
19
20
21
22
24
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1.1 Operating Principle
This device is an unit that consists of a main body, BLDC (brushless DC) motor, and foot pedal switch
for driving and operating a handpiece for dental implant procedures, to be used in dentistry in the field
of implant surgery.
The main body of this device is powered by an external power supply that converts alternating current
to direct current, which turns the BLDC motor; the rotation power of which combines with the handpiece
to perform the dental implant procedure.
The main body of the implant unit can be adjusted in terms of its torque, rotation speed, water injection
volume, and rotational direction.
The BLDC motor can be operated using the foot pedal switch.
1.2 Purpose of Use
This is an engine used to power handpieces used for implants when performing
dental implant procedures.
1.3 Users
Only qualified dentists may use this device in a professional environment..
1.4 Indications of Use
1) Where there is an absence of gum or teeth caused by cavities, gum disease, accidents or tumors.
2) Where enamel ablation is not recommended so as to protect the adjacent natural teeth.
3) Where the patient does not want denture treatment.
4) Where the patient wants to replace partial or full dentures that were previously used with a fixed-type
dental prosthesis.
5) Where the patient wants full dentures to be replaced with some partial dentures and some fixed-type.
6) Where the patient requires implant support in relation to the lower dentures to maintain the full denture
and also improve its function.
1) Be sure to read the user manual prior to use.
2) Only to be used by a professional in a professional environment..
3) Not to be used for anything other than its intended use.
1.5 Checklist Prior to Use
Chapter 1. Overview
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2.1 Danger
1) When cause of abnormality is not detected or abnormality is not easily solved,
contact the head office immediately.
2) When the display is wrongly shown, make inquiries to the head office. It is at risk for accident.
3) Do not bring any patient into contact with signal input section or signal output section and
other connections.
2.2 Warning
1) Do not disassemble or make alterations to the product. Once the product is disassembled,
you cannot get after-sale service from the company.
2) Do not inject oil into BLDC motor. It causes bearing breakdown and heat.
3) Do not clean the product using a solvent such as thinner, benzene, etc.
4) Use accessories and consumables provided with the product in accordance with specifications
required by the company. When specifications other than required ones are used,
it is at risk for accident.
5) When power cord, plug or socket is broken or damaged, do not use the product but make
inquiries to the company. It is at risk for (electric) shock and fire.
6) Hold the plug to unplug the power cord and do not hold the plug with a wet hand.
Also, do not use the product when the power plug is loose. It is at risk for electric shock and fire.
7)
Do not locate near heating instruments or put a candle or a light around the product. It is at risk for fire.
8) Watch carefully whether the elderly and the infirm, the disabled or children are close to where
the product is located and do not leave children alone.
9) Be careful not to drop foreign substances such as water and saline solution on implant engine
controller and foot switch. When the product does not work normally or foreign substances are
in the product, do not operate the product but make inquiries to the company.
10) Use the product only with intended use written in this manual and do not use in any way
which is not recommended by the manufacturer.
The company is not liable for accident resulting from not observing the instruction manual.
11) Exterior equipment to connect to signal input section, signal output section and other connections
should comply with relevant IEC standards.
12) To avoid the risk of electrical shock, this product must only be connected to a power source
with protective earth.
13) Warning statement referring to the necessity for periodic checking or replacement of such an
additional power source
14) Contain an instruction not to position the product so that it is difficult to operate the disconnection
device.
15) Don’t use the foot switch in the places that there is water, like the emergency room or the
operating room.
16) Do not modify this equipment without authorization of the manufacturer.
17) Do not use a mobile phone or wireless RF communication device near the electric medical device
to prevent adverse effect on the device.
Chapter 2. Safety (Warnings and Cautions)
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2.3 Caution
1) When any abnormality such as vibration, heat and strange sound is detected before or during use,
stop using the product immediately and examine it.
2) Prepare extra consumables in using the product.
3) Ensure that speed which is recommended by the manufacturer is maintained on tools used for
implant surgery. It is at risk for accident when it exceeds the permitted speed.
2.4 Notice
1) This product is manufactured to be used for implant surgery.
Ensure that the product is use in accordance with the intended use and correct procedure.
2) With priority to patient's safety, use the product with good care.
3) Read the instruction and thoroughly understand functions of each component before use.
4) Implant engine controller and foot switch are not subject to Autoclave.
When main body is contaminated by pollutant, turn the power off,
clean the product with clean and wet cloth and remove moisture with dry cloth.
5) Check whether input voltage corresponds with actual voltage after connecting the power supply.
6) Dispose irrigation tube as medical wastes after use.
Chapter 2. Safety
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Chapter 3. Product Description
3.1 Description of System, Components and Functions
3.1.1 Main Controller
1) Front
2) Rear
3) Pannel
M
COOLANT
P
GEAR RATIO
TORQUE SPEED
FOR/REV
S
PUSH
Display
Irrigation fixing part
Irrigation device switch
Motor connection
M
COOLANT
P
GEAR RATIO
TORQUE SPEED
FOR/REV
S
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Irrigation hanger connection partPower cord connection part
Gear Ratio buttonProgram button
Memory button
System button
Torque button
Control Button
Rotation button
Coolant button
Rotation Speed Button
Power switch Foot switch connection part

Chapter 3. Product Description
4) Display / ISE-170C, ISE-170L
①
④
⑤
⑥
② ③
⑦
⑧
⑨
Program display
Memory
Gear ratio display
Display for direction of rotation
Optic LED Display
Error display
Torque display
Speed display
Coolant display
Indicates function being used during surgery.
Memory indicates the number of saved set value in using it.
Indicates gear ratio currently selected for use.
Indicates injection a mount of water in 5 levels.
Indicates the status of the motor LED.
Indicates direction of motor's rotation and flickers during
operation of engine.
Error indicates the corresponding number of error upon its
occurrence.
Indicates the set torque value upon operation stand-by and the
ratio of actual load torque compared to set torque value during operation.
Indicates the set rotation speed upon operation stand-by
and the actual rotation speed during operation.
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Name Function

Chapter 3. Product Description
3.1.2 Foot switch (FS-V1)
3.1.3 Motor (ISM-B70L)
Optic LED
Handpiece connection Motor connection
Coolant button
Operation button
Hanger hole
Foot switch cable
Foot switch connector
Rotation button
Program button
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Chapter 3. Product Description
3.2 Product Performance
1) Main controller (ISE-170C / ISE-170L)
2) Motor (ISM-B70L)
Power Supply Voltage
Frequency
Power Consumption
100-120/220-240 V
50/60Hz
150VA
Max. Coolant flow rate
Fuse
Dimension
130 ml/min
2 × T2AL 250V
300×230×135 ㎜ [Width×Length×Height]
Speed
Max. Torque
Max. Current
200 ~ 40,000 rpm
7 Ncm
Speed control
3) Foot Switch (FS-V1)
Control Functions
Variable
Program control / Coolant control / Forward/Reverse
6 A
Dimension
Optic
Weight
Ø24 × L100 ㎜
White LED
156g
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3.3 Classification of Device
3.3.1 Type of protection against electric shock
ClassⅠ equipment
3.3.2 Degree of protection against electric shock
Type BF applied part :
3.3.3 Mode of operation
Continuous operation
3.3.4 Applied parts
Handpiece: Used in connection with a micromotor
※ Handpieces are not included in the this package.
Chapter 3. Product Description
3.4 Environmental Conditions (Storage, Relocation, Operation)
1) Storage conditions
Temperature : -10°C ~ +50°C
Humidity : 10 ~ 85%
Air pressure : 500hPa ~ 1060hPa
2) Relocation conditions
Temperature : -10°C ~ +50°C
Humidity : 10 ~ 85%
Air pressure : 500hPa ~ 1060hPa
3) Operation conditions
Temperature : +10°C ~ +35°C
Humidity : 30 ~ 85%
Air pressure : 700~1060 hPa
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4.1 Installation of hanger and Foot switch hanger
4.2 Connection of Motor
① Insert Irrigation Hanger into Hanger hole.
② Fix by connecting Hanger bolt.
① Insert Foot switch hanger into Hanger hole.
② Fix by connecting Hanger bolt.
① Fit the motor connector into groove.
② Connect the motor connector CAP.
Be careful to fit into the connector
upon connection.
Chapter 4. Installation
4.1.1 Installation of hanger
4.1.2 Installation of Foot switch hanger
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Chapter 4. Installation
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Spray Clip
20:1
Irrigation tube
① Attach the irrigation tube to the straight or
contra-angle handpiece.
Irrigation tube Tube clip
Irrigation tube
Tube clip
Motor cable
Irrigation tube
coolant clip
② Attach the motor cable and irrigation tube
in regular intervals using the coolant clip.
③ Open Irrigation cover by pressing Push button.
④ Put Irrigation tube in the groove.
⑤ Close Irrigation cover.
PUSH
4.3 Installation of irrigation tube

Chapter 4. Installation
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① Attach the irrigation tube to the straight or
contra-angle handpiece.
Tube clip
Coolant container
Insert needle
① Stick the insert needle into the coolant container.
② Hook-in the coolant container on the bottle holder.
③ Close the tube clip.
④ Open the tube clamp before start-up.
4.4 Connection of power cord and foot switch
4.5 Disconnection
① Connect power cable to power cable termianl.
② Connect Foot switch connector to Foot switch terminal
Be careful to fit into the groove
upon connection.
① ②
Disconnection of the product takes place in reverse order of connection.

5.1 General use
5.2 Program Mode
① Turn on the Power switch of implant engine controller.
② Programs are selected in turn by pressing Foot switch or Program button of implant engine controller.
③ Check the displayed Torque, Speed, Coolant, Gear and Direction of rotation.
④ It starts rotating upon pressing Foot switch. It rotates at low speed with light press on Foot switch
and rotates at full speed with hard press. When water injection status is preset,
Pump starts rotating as well.
( For the convenience of the operator and the safety of the patient, a slow start function is installed
that gradually reaches the set rotation value in 2-3 seconds)
⑤ When load reaches the maximum value of preset torque during use, motor stops rotating.
⑥ It stops rotating upon releasing Foot switch.
A user selects a program necessary for surgery with this button.
Program alters in turn from number 1 to 6 upon pressing Program
button each time. It alters in order of Drilling→Tapping→Remove Tap
→Implant→Remove→Lock screw.
Cursor locates on border of the selected program.
Program
Button
Chapter 5. Operation
5.2.1 Selecting a program
This function deletes an unnecessary and unused programs.
Selects an unused program and Deletes pressing this button more
than 3 seconds.
Program
Button
5.2.2 Deleting a program
This function restores the deleted programs.
Restores all deleted programs pressing this button more than 2 seconds.
Memory
Button
5.2.3 Restoring programs
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M

5.3 Memory function
It loads memory address where detailed figures (Gear ratio, Torque,
Speed, For/Rev, Coolant) of each function in program are saved.
Memory address alters in turn from number 1 to 9 upon pressing
Memory button each time.
Memory
Button
Chapter 5. Operation
5.3.1 Memory number
M
It saves detailed figures in memory which are currently set
(Gear ratio, Torque, Speed, For/Rev, Coolant) for each function in program.
Press and hold the memory button for 2 seconds and the border with the
memory number flashes along with a beep.
Press the memory button to select a memory address to store the number,
and press the system button for 2 seconds, the frame with the memory
number will flash alternately, and the frame will be off with a beep sound,
then the saving is complete.
5.3.2 Saving data
Program
Drilling
Tapping
Remove tap
Implant
Remove
Lock screw
Gear ratio
20:1
20:1
20:1
20:1
20:1
20:1
Torque[Ncm]
55
40
40
40
55
10
Speed[rpm]
1,500
50
50
50
50
50
Motor diriection
Foward
Foward
Reverse
Foward
Reverse
Foward
Coolant level
4
3
3
3
0
0
LCD DIsplay Memory1
① Drilling
set value
② Tapping
set value
③ Remove tap
set value
④ Implant
set value
⑤ Remove
set value
⑥ Lock screw
set value
① Drilling
set value
② Tapping
set value
③ Remove tap
set value
④ Implant
set value
⑤ Remove
set value
⑥ Lock screw
set value
① Drilling
set value
② Tapping
set value
③ Remove tap
set value
④ Implant
set value
⑤ Remove
set value
⑥ Lock screw
set value
Memory2 Memory3
※ Initial setting (Factory settings) : Memory
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System
Button
S

5.4 LED On/Off
Press Optic/Non optic button to operate LED within the motor
ISM-B70L which is designed for Optic.
LED On/Off
Button
Chapter 5. Operation
S
5.5 Gear ratio change
It selects gear ratio in accordance with that on handpiece.
Gear ratio alters upon pressing Gear ratio button each time.
Gear Ratio :
① 1:1 ② 1:2 ③ 16:1 ④ 20:1 ⑤ 27:1 ⑥ 32:1
It alters in turn from number ① to ⑥ upon pressing
the button each time.
Gear ratio
Button
GEAR RATIO
5.6 Setting direction of motor rotation
The initial setting is Forward direction and Reverse is selected upon
pressing the button.
The letter and arrow are turned on upon selecting Reverse with beep.
① The letter and arrow are turned on upon selecting Forward.
② he letter and arrow flickers during the motor operation.
③ he same goes for selecting Reverse with beep.
Rotation
Button
FOR/REV
5.7 Controlling water injection rate
Water injection rate alters in turn by five levels upon pressing Coolant button.
Coolant
Button
FOR/REV
LCD Display
LCD Display
LCD Display
COOLANT
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① 30ml/min ② 60ml/min ③ 90ml/min
④ 110ml/min ⑤130ml/min

5.8 Change in torque value (Main function)
Torque section on the display flickers upon pressing torque button.
Torque is controlled using the button for adjusting set value.
Torque setting mode is released upon pressing Torque button again
or another button on other function or when the motor operates.
Torque
Button
Control
Button
Chapter 5. Operation
TORQUE
LCD Display
5.9 Change in speed (Main function)
Speed section on the display flickers upon pressing Speed button.
Speed is controlled using the button(up/dawn button) for adjusting set value.
Speed setting mode is released upon pressing Speed button again or
another button on other function or when the motor operates.
Speed
Button
Control
Button LCD Display
SPEED
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5.11 Auto Calibration
It is performed when the error of motor's rotation speed is higher than the set
speed during operation of implant engine.
When 'Set value adjustment button' are pressed at the same time,
the motor starts with a beep sound, the speed increases from 0 to 40,000 rpm
on the display, then the motor stops, and calibration is complete.
Check the set speed and actual speed by restarting the implant engine.
Auto Calibration is performed upon simultaneously
pressing both buttons longer than 2 seconds.
5.12 Operation of implant engine (Main function)
Implant engine operates upon completion of all settings.
When motor operates by pressing Foot switch, the letter 'R'
on display and the surrounding border flickers in turn.
The torque and speed indicate the current figures and
a beep sounds when altered torque value reaches 90%
of set value.
Motor stops when it reaches 100% of set value.
Control
Button
Chapter 55. Operation
LCD Display
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5.10 Thread cutting function
Activating the thread cutting function is only possible with the
Tapping program.
① Forward rotation ② Reverse rotation
When loading
beyond the preset
torque limit value
③ Rotation stop
When foot switch off
④ Forward rotation
When foot switch on
LCD Display

6.1 Manual cleaning
1) Separate the motor and Foot Switch connected in the Control Unit.
2) Prepare a cloth (preferably cotton) or soft brush moistened with isopropyl alcohol.
3) Clean foreign substance on the entire surface and in the gaps with cloth or brush
soaked in isopropyl alcohol for at least 2 minutes.
4) Repeat the cleaning process if foreign substance is found.
6.2 Inspection
1) Inspect whether there is any foreign substance visible to the naked eye.
2) Check the operating condition.
3) Repeat the cleaning process if foreign substance is found.
4) Repeat the above procedure for every single use.
Clean the product before and after use.
6.3 Sterilization
6.4 Change fuse
Sterilization of motor and irrigation tube by moist heat in accordance with ISO
17665-1, 2 in a steam sterilizer (Autoclave).
1) Gravity displacement type sterilizer
- At least 30 minutes at 121℃
- Drying time: 30 minutes.
2) Air-removal steam sterilization(pre-vacuum)
- At least 4 minutes at 132℃
- Drying time: 30 minutes.
Chapter 6. Maintenance
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Extra fuse
Needed
to change
① Remove the fuse box with a flat screwdriver.
② Replace the fuses by the new ones.
③ Put the fuse box.