MicroNX ELEC ENGINE ISE-170L Instructions For Use Manual Download Page 23

9.1 Electromagnetic Emission

The product is suitable for use in an specific electromagnetic environment. 
The customer and/or the user of the product should assure that it is used in an electromagnetic 
environment as described below.

9.2 Electromagnetic Immunity

The product is suitable for use in a specific electromagnetic environment. 
The customer and/or the user of the product should assure that it is used in an electromagnetic 
environment as described below.
In a particular electromagnetic environment, the Dental Engine for Implant Surgery should meet the 
following essential performance. The criteria for compliance specified by the Micro-NX Co., Ltd. is as follow. 
It is to maintain water supply and the motor speed. The speed should have an error of less than 10%.

Chapter 9. Electromagnetic Compatibility

22/24

RF-emission

CISPR 11

RF-emission

CISPR 11

Harmonic emissions

IEC 6100-3-2

Voltage fluctuations /

flicker emissions IEC 61000-3-3

Group 1

Class B

Class A

complies

The product use RF energy only for its internal function. 

Therefore, its RF emissions are very low and not likely to 

cause any interference in nearby electronic equipment.

The product is suitable for use in all establishments, 

including domestic establishments and those directly 

connected to the public low-voltage power supply 

network that supplies buildings used for domestic purpose.

Emission Test

Compliance

Electromagnetic Environment Guidance

Electrostatic

discharge(ESD)
IEC61000-4-2

± 8kV contact

± 15kV air

± 8kV contact

± 15kV air

Floor should be wood, concrete or ceramic tile.

If floors are covered with synthetic material, 

the relative humidity should be at least 30%

Electrical fast

transient/bursts
IEC61000-4-4

± 2kV for power

supply lines

± 1kV for

input/output lines

± 2kV for power 

supply lines

N/A

Mains power quality should be that of a typical

commercial and/or hospital environment

Surge

IEC61000-4-5

± 1kV line to line

± 2kV line to earth

± 1kV line to line

± 2kV line to earth

Mains power quality should be that of a typical

commercial or hospital environment

Immunity Test

IEC 60601- Level

Compliance Level

Electromagnetic

Environment Guidance

Summary of Contents for ELEC ENGINE ISE-170L

Page 1: ...Dental Engine for Implant Surgery ISE 170C ISE 170L INSTRUCTIONS FOR USE...

Page 2: ...tist 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...

Page 3: ...apter 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 Chapt...

Page 4: ...en 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...

Page 5: ...ully 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...

Page 6: ...ant 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 thoro...

Page 7: ...PUSH Display Irrigation fixing part Irrigation device switch Motor connection M COOLANT P GEAR RATIO TORQUE SPEED FOR REV S 6 24 Irrigation hanger connection part Power cord connection part Gear Ratio...

Page 8: ...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...

Page 9: ...cription 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 butto...

Page 10: ...sumption 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 F...

Page 11: ...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 Temper...

Page 12: ...by connecting Hanger bolt Insert Foot switch hanger into Hanger hole Fix by connecting Hanger bolt Fit the motor connector into groove Connect the motor connector CAP Be careful to fit into the conne...

Page 13: ...ce Irrigation tube Tube clip Irrigation tube Tube clip Motor cable Irrigation tube coolant clip Attach the motor cable and irrigation tube in regular intervals using the coolant clip Open Irrigation c...

Page 14: ...Hook in the coolant container on the bottle holder Close the tube clip Open the tube clamp before start up 4 4 Connection of power cord and foot switch 4 5 Disconnection Connect power cable to power...

Page 15: ...e in 2 3 seconds When load reaches the maximum value of preset torque during use motor stops rotating It stops rotating upon releasing Foot switch A user selects a program necessary for surgery with t...

Page 16: ...ds 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...

Page 17: ...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 b...

Page 18: ...er 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 b...

Page 19: ...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 fl...

Page 20: ...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 Chang...

Page 21: ...sking for repair Replacing fuse Checking the connection Asking for repair Inaccurate connection of power cord Breakdown of foot switch Breakdown of power cord Breakdown of fuse Motor does not operate...

Page 22: ...d Made in Republic of Korea Factory 22 Maeyeo ro 1 gil Dong gu Daegu 41059 Republic of Korea 82 53 650 1000 8 3 Warranty Warranty period of the product Life of components and replacement cycle Implant...

Page 23: ...lass A complies The product use RF energy only for its internal function Therefore its RF emissions are very low and not likely to cause any interference in nearby electronic equipment The product is...

Page 24: ...s 150 kHz to 80 MHz 6 Vrms in ISM bands 150 kHz to 80 MHz 80 AM at 1 kHz 30 A m Magnetic fields generated by the mains frequency should be at levels characteristic of a typical location in a typical c...

Page 25: ...l 10 1 1 Disposal of Main controller and foot switch and motor All packaging materials have been selected according to environmentally compatible and disposal aspects and can be recycled Please send o...

Page 26: ...nd production of this medical device 22 Maeyeo ro 1 gil 41059 Republic of Korea Tel 82 53 650 1000 Fax 82 53 650 1001 Web www micronx co kr Karl Marx Str 6 16540 Hohen Neuendorf Germany Tel 49 0 3303...

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