Ti-Max NLX nano Micromotor System Operation Manual Feb 2013

CAUTION Unit · Grasp cord by plug to remove from outlet. DO NOT pull or yank on the cord itself. It may cause a wire disconnection or malfunction. · Care should be taken not to place the AC Cord near a gas burner. Never attempt to repair a burned motor cord. Always replace it with a new cord. · Prior to use, always check for vibration, noise and overheatin, If any abnormalities are detected, stop using immediately and contact your authorized NSK Dealer. · Be careful not to spill water onto the Unit as this may result in a fire or an electric shock due to a short-circuit. Motor,Handpieace(Option) · Do not use this product under strong stress for long time. It is cause overheat · Do not connect or disconnect the cord until the drive motor has completely stopped. · Do not connect / disconnect the handpiece during operation. · Verify that the Speed Control Switch is adjusted within the allowable speed before use. · Connect only 4-hole, 5-hole or 6-pin tubing. · Air Requirements: dry, free from contamination and oil. Use a compressor with a dry air system. Install an air filter if necessary. Blow out the lines before installation. · Do not Autoclave (or any other high temperature Sterilization) Control Box, AC Adapter, Motor Cord. · The user shall be responsible for operation, maintenance and operation. · The operator is responsible for correct operational control, maintenance and inspection. · Surface temperature shall be more than 60 ºC without using a coolant air, to avoid this event, be sure to use coolant air.

NOTICE · During rotation, the motor and the motor cord may affect computer and LAN cable. Noise could be heard during operation near a radio receiver. · After treatment, immediately turn off the power switch and shut off the air supply.Remove the power cord if the unit box is not to be used for a long time. · Responsibility for operating and maintaining Medical Devices belongs to the user. · Store the system in the place where the temperature is at -10-60°C (14-140°F), humidity at 10-85%RH, atmospheric pressure at 500-1060 hPa, and the system is not subject to air with dust, sulfur, or salinity.

1. Specification AC Adaptor

Control Box Model Rated input Drive Air Pressure Dimensions

NLX nanoU (NE278) AC28V 50/60 Hz 0.4MPa (4.0kgf/cm2) W127 x D149 x H54 mm

Model Rated input Output Fuse

Motor Model Rotation Speed Dimensions

NLX nano 2,000 - 40,000 min-1 DØ22 x H70 mm

Water Supply Chip Air Coolant Air Supply

More than 65 mL/min (0.2MPa) More than 1.5 L/min (0.2MPa) More than 6.5 NL/min (0.2MPa)

Dimensions



AC Adaptor(NE180) AC120V 50/60Hz 41VA AC230V 50/60Hz 41VA AC28V 1.3A AC120V TR5-T C1 250V 19372 T1.6A AC230V TR5-T C1 250V 800mA W100 x D178 x H64 mm

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1 2

3

4

5

7

8

15

14

6

16

17

1 2 3 4 5 6 7 8 9

Control Box Indicator Gear Ratio Lamp Gear Ratio Select Key FWD/REV Select Key Rotation Speed Adjustment Key M1 Key M2 Key Power Switch

10 11 12 13 14 15 16 17 18



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AC Adapter Connector Motor Cord Connector Turbine Hose Connector Motor Protection Plug Motor Cap Motor Cord (Unshielded 2.2m) AC Cord (Unshielded 2.0m) AC Adaptor (Unshielded cord 5.0m)

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2. Component Names

3. Operating Control Box CAUTION · Be sure that there is no air or water coming from Turbine Hose when connecting to control box. · Hand tighten the Nut properly without unnatural force, when you plug into Turbine Hose Connector and Motor Cord Connector. 3-1 Connect the handpiece tubing from the delivery unit you are using Fit the Turbine Hose Plug of the delivery unit to the Turbine Hose Connector piping and tighten completely. (Fig. 1)

Turbine Hose Connector

Turbine Hose Plug

CAUTION

Motor Cord Connector

· Do not use it other than the hose which we appointed. · Do not use wet or contaminated air. · Install an air filter if necessary. Blow out the lines before installation.

Fig.1

3-2 Connecting the Motor Connect the motor by aligning the Motor Cord Plug and insert firmly. Tighten it completely. (Fig. 2) Motor Cord Plug

3-3 Connecting the AC adapter Insert the AC adapter plug into the AC adapter connector before pugging into wall outlet. (Fig. 3)

Fig.2

CAUTION Never use the AC Adapter for other than the Control Box of this product.

AC Adaptor Plug

Fig.3

3-4 Connecting the Power Cord Insert the Power Cord into the Inlet of AC Adapter. (Fig. 4) Inlet AC Cord

Fig.4



4-1 Connecting / disconnecting the motor and the motor cord Align and insert firmly the Motor Pin into the pin holes of the Motor Cord Connector, and fasten the Motor Cord Nut securely. (Fig. 5)

Motor

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4. Handling the Motor Motor Cord Connector

To remove the Motor Cord from the Motor, unscrew and detach the motor cord nut, and gently pull out the motor cord connector.

Motor Cord Nut Motor Cord

Fig.5 4-2 Connectioning / disconnecting the motor and the handpiece To insert the E-type handpiece in the Motor Insert, align handpiece and motor, then turn those until its click. (Positioning pins are aligned)

Handpiece (Option) Positioning Pin

To remove the handpiece, simply pull out the handpiece from the motor.

Motor Insert

Handpiece (not included in NLX nano set.)

Fig.6

CAUTION · Care should be taken when using any handpiece attachment which requires lubrication (E Type Micromotor). Following lubrication stand the handpiece attachment vertically until the excess solution drains. Wipe the handpiece then attach it to the Micromotor. · Do not connect or disconnect the handpiece until the motor has completely stopped.

5. Operation Section 5-1 Insert the Power Cord Plug in AC outlet and turn the Power Switch on. When you turn on the Power Switch, lamps and Indicator will come on.

Power Switch Symbol Mark Function

OFF

ON

5-2 Before using this system, make sure to do the Foot Air Calibration function. (See 6-1 Foot Air Calibration) 5-3 Push the Gear Ratio Select Key to indicate the speed of the attachment you will use. (Fig. 7) During Speed Setting, Indicator display "Speed". For detail display, check table below. Speed Display Table Handpiece Indicator Gear Ratio 16:1 1 - 25 1:1 2 - 40 1:5 1 - 20

Gear Ratio Lamp

PUSH

Speed (min-1(rpm))

Fig.7

100 - 2,500 2,000 - 40,000 10,000 - 200,000



5-4 Set the maximum speed using the Rotation Speed Adjustment Key ( ) . (Fig. 8)

Indicator

Increase

Decrease

Fig.8 5-5 Select FWD/REV rotation using the FWD/REV Select Key. (Fig. 9) Lamp ON REV Lamp OFF FWD

FWD/REV Lamp

PUSH

5-6 The micromotor operation will be controlled by the air switch/Foot Pedal of the delivery unit. Fig.9

6. Convenient Functions 6-1 Foot Air Calibration

(Unit of Display = kgf/cm2)

By using this function, it enables you to use the maximum speed, 40,000 min-1(rpm), even though the air pressure of the delivery system is not high enough, by setting upper and lower limit of the air pressure.

NOTICE Do this adjustment function after your purchase. Once it is adjusted, it will be memorized, and there is no need to do this everytime. 1) Press M2 key and Rotation Speed Adjustment Key( ) at the same time for more than 3 seconds. 2) With alarm sound, Indicator will change to "C1" (Lower air pressure limit setting mode). 3) By pressing the FWD/REV Rotation key, Speed Indicator shows " 0.0" and "Eb" mutually. 4) By stepping the Foot Pedal of the delivery unit, Indicator shows the present air pressure.

NOTICE · The displayed air pressure is only a guideline. Measure the correct air pressure with the air gauge. · The unit of displayed air pressure is "kgf/cm2". For other unit, refer the bellow. ex) 0.1 0.01MPa 1.0 0.1MPa 3.0 0.3MPa. 5) Control the Foot Pedal of the delivery unit, and maintain the air pressure between "0.3 " - "1.0". Press M2 key for more than 3 seconds to memorize the lower limit of the air pressure.

NOTICE · Default value is set to "0.5" . · When the air pressure is not between "0.3" - "1.0", it is displayed "Eb", and will not be memorized



NOTICE The displayed air pressure is only a guideline. Measure the correct air pressure with the air meter. 9) Control the Foot Pedal of the delivery system, and maintain the air pressure between "2.0" - "4.0". Press M2 key until it beep (more than 3 seconds) to memorize the upper limit of the air pressure.

NOTICE · Default value is set to "3.0". · When the air pressure is not between "2.0" - "4.0", it is displayed "Ec", and will not be memorized. 10) Press both M2 key and Speed Adjustment Key( ) at the same time until it beep (more than 3 seconds), once again. When it alarmed, this setting has completed. By setting Indicator by pressing Rotation Speed Key to " 40", and now it is ready to use at the maximum speed, 40,000 min-1(rpm). 6-2 Light Brightness Adjusting Function (Unit of Display = V)

Brightness of the Fiber Optic can be adjusted from this function. 1) Press M2 Key and Speed Adjustment Key( ) at the same time until it beep (more than 3 seconds). 2) With alarm sound, Indicator will change to " C1". Pressing the Gear Ratio Select key can change the Indicator and Gear Ratio Lamp (C1 C2 C3 C1….) Set indicator in C3 (Light Brightness adjustment mode).Press FWD/REV Rotation Key to proceed. ) and adjust the brightness. 3) When Indicator changed to " 3.5"(Default value), press Speed Adjustment Key(

NOTICE · Default value is set to " 3.5". · Adjustable between "1.6" - "3.6". 4) Press M2 key until it beep (more than 3 seconds) to set the brightness. 5) Press M2 key and Speed Adjustment Key( ) at the same time for more than 3 seconds, once again. When it alarmed, this setting has completed. 6-3 Program Function It is possible to memorize settings (Speed, Gear Ratio, Forward/Reverse Direction) After the setting, you can use your settings by pressing M1, M2 Key. 1) Set the values for Speed, Gear Ratio, Forward/Reverse Direction. 2) Press M1 Key or M2 Key until it beep (more than 3 seconds). When it alarmed, this setting has completed.



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6) After setting lower limit, press Gear Ratio Select Key. Indicator will change to "C2 " (Upper air pressure limit setting mode). 7) By pressing the FWD/REV Rotaion Key, Indicator shows " 0.0" and "Ec" mutually. 8) By stepping the Foot Pedal of the delivery system, Indicator shows the current air pressure.

7. Sterilization Sterilize the motor only. For the sterilization method, we recommend the autoclave sterilization method. Sterilization is required first time you use and after each patient as noted below. Autoclaving Protection Plug 1) Turn off the Power. 2) Detach the motor from the Motor Cord. (Refer to 4-1 Connecting / disconnecting the Motor and the Motor Cord) 3) Clean the surface of the motor with brush etc. (Do not use the metal brush), and wipe it with the cotton moistened with disinfecting alcohol. 4) Screw the Motor Cap to the Motor. Put the Protection Plug to the motor insert. (Fig. 10) 5) Insert into an autoclave pouch. Seal the pouch. 6) Autoclavable up to max. 135°C. ex.) Autoclave for 20 min. at 121°C, or 15 min. at 132°C. 7) Keep the Motor in the autoclave pouch to keep it clean until you use it. Sterilization at 121°C for more than 15 minutes is recommended by EN13060 or EN ISO17665-1.

Motor Cap

Tighten Fig.10

CAUTION · Do not Autoclave (or any other high temperature Sterilization) Control Box, AC Adapter, Motor Cord. · Do not lubricate the motor. · Do not wipe nor immerse the system in acidic water or acidic solutions. · Do not sterilize with dirt on the surface. It might cause rust. · Do not use Protection Plug without the mounting O-Ring. It may cause a malfunction. If O-Ring had damaged, replace it immediately. O-Ring (Protection Plug ): Order code 0312457102 · You can hang Protection Plug on the anywhere to prevent loosing it. · Do not hung the Protection Plug with motor. It may drop the motor and cause damage.

8. Maintenance If the O-Ring became depleted, such as difficult to connect the handpiece or air or water might leak, replace the O-Ring. (1) Changing the Oring Remove the O-Ring at the Motor Insert with a pointed tool, and mount the new O-Rings into the groove.

Fig.11

CAUTION There are 4 O-Rings on the Motor Insert. Blue one is thinner than other 3 pieces. Make sure to order it.

O-Ring (Blue)

O-Ring (Black)



CAUTION English

It might happen if the O-Ring becomes depleted. · Air/Water leak · Air/Water does not came off · Vibration · Difficult to connect/disconnect the handpiece

9. Error Code If the motor stops due to an abnormality such as a malfunction, overload, break or incorrect usage, it automatically checks the state of the Control Box and detects the cause of the abnormality and displays an error code on the Indicator. If an error code is displayed, turn on the power again and check whether the same error code is displayed. If the same error code is displayed, take action by referring to the instructions provided in the "Check/Remedy" column in the following table. Error Code E0

Trouble

E2

Overcurrent error. (In circuit) Overcurrent error. (In software) Retry Error

E3 E5 E6

ITRIP Error Overvoltage Input Error LED voltage Error

E8

Overheat Error

E9

Motor Start Error

EA

LED voltage Error

Eb

Air Offset Error

Ec

Air Full Scale Error

EE

EEPROM Error

E1

Cause

Check/Remedy

Detected overcurrent in the circuit.

Contact your dealer.

Detected overcurrent in the software.

Contact your dealer.

Motor stopped by the overload, and not Contact your dealer. able to restart. Faulty Motor or Internal circuit. Contact your dealer. Overvoltage is given to the Control Box. Contact your dealer. Overvoltage is given (more than 3.7V) Contact your dealer. from the Internal circuit. High temperature safe system is Cool it down for a while, and try again. functioning, due to long-time use at a high load. - Motor didn't reach the preset speed in a Contact your dealer. prescribed period of time. - Break down of a motor cord wire, or internal circuit malfunction. Voltage for the LED didin't reach the Contact your dealer. preset speed in a prescribed period of time. Lower than preset " Lower limit of the air Displayed by Foot Air Calibration function. pressure" Not a malfunction. - Higher than preset "Upper limit of the air Displayed by Foot Air Calibration function. pressure". Not a malfunction. - Air pressure higher than 0.4MPa (4.0kgf/ cm2) is given. Malfunction of the memory for the setting Contact your dealer. values.



10. Troubleshooting When trouble is found, check the following again before consulting NSK dealer. If none of these is applicable or the the trouble is not remedied even after action has been taken, a failure of this product is suspected. Check/Remedy Pilot Lamp does not light.

Cause Solution Power Switch is OFF. Turn ON the switch. AC Adapter is not connected correctly. Check the connection. Internal Fuse is blown, due to some reason. Contact your dealer. Motor does not run Tubing, Motor Cord, AC Adapter is not connected Check the connection. correctly. Air pressure is not given, or not proper from the Check the air pressure of the delivery delivery unit. system. Check the ERROR CODE in the Indicator. Refer to 9. ERROR CODE. The rotation speed does not Air pressure is not given, or not proper from the Check the air pressure of the delivery rise. delivery unit. system. Air pressure of the delivery unit is lower than the Do "6-1 Foot Air Calibration". “Lower limit of the air pressure”. It beeps when turn on the You are stepping on the Foot Pedal when turning on Do not step the Foot Pedal, and turn on the switch. the power switch. (Safety function) power switch. LED does not light. Reached the end of life expectancy. Contact your dealer. Motor heats up abnormally Coolant air is not given, or not proper from the Check the air pressure of the delivery during rotation. delivery unit. system. Water leakage Tubing, Motor Cord is not connected correctly. Contact your dealer. If it is from Control Box, something is wrong within Check the connection. the Control Box. When turned on, the setting Turned off the motor while rotating. Turn off after the Motor has stopped. values are different from what used to be when turned off.

11. Warranty Manufacturer warrants its products to the original purchaser against defects in material and workmanship under normal practices of installation, use and servicing. are expendable components, and are not covered by this warranty. In case the product fails within 30 days from the date of installation, immediately report with the proof of your purchase to the dealer you purchased from.

12. Disposing Product Consult with dealer from whom you purchased it about waster despoil.

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TUV Rhineland of North America is a Nationally Recognized Testing Laboratory (NRTL) in the United States and is accredited by the Standards Council of Canada to certify electro-medical products with Canadian National Standards. Follow the waste of electric and electronic equipment (WEEE) Directive (2002/96/EC) to dispose of the product and accessories. Consult operation instructions.

Manufacturer.

Class II Equipment.

This conforms to CE European Directive of “Medical equipment directive 93/42/EEC.” Autoclavable up to Max.135°C. *for detail see Sterilization.

Type B applied part.

Marking on the outside of Equipment or Equipment parts that include RF transmitters or that apply RF electromagnetic energy for diagnosis or treatment.

Guidance and manufacturer's declaration - electromagnetic emissions The NLX nano is intended for use in the electromagnetic environment specified below. The customer or the user of the NLX nano and manual should assure that is used in such an environment. Emissions test Emissions test Electromagnetic environment - guidance RF emissions CISPR11 Group 1 The NLX nano uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emmissions CISPR11 class B The NLX nano is suitable for use in all establishments, including domestic estabilishments and those directly connected to the public low-voltage power supply network that supplynetwork that spplies buidings used for Harmonic emissions class A domestic purposes. IEC61000-3-2 (*)This applies to the AC230V system. For AC120V system, this is “Not applicable”. Voltage fluctuations/flicker Complies emissions IEC61000-3-3 Guidance and manufacturer's declaration - electromagnetic immunity The NLX nano is intended for use in the electromagnetic environment specified below. The customer or the user of the NLX nano and manual should assure that it is used in such an environment. Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) ±6kV contact ±6kV contact Floors should be wood, concrete or ceramic tile. If floors are covered ±8kV air ±8kV air with synthetic material, the relative humidity should be at least 30%. IEC61000-4-2 Electrical fast transient/burst ±2kV for power supply ±2kV for power supply lines Mains power quality should be that of a typical commercial or hospital lines No input/output line environment. IEC61000-4-4 ±1kV for input/output ±1kV line to line Surge IEC61000-4-5 ±1kV line(s) to line(s) Mains power quality should be that of a typical commercial or hospital ±2kV line(s) to earth ±2kV lines to earth environment. Voltage dips, short <5% Ut <5% Ut Mains power quality should be that of a typical commercial or hospital interruptions and voltage (>95% dip in Ut) for 0.5 (>95% dip in Ut) for 0.5 cycle environment. If the user of the NLX nano requires continued operation variations on power supply cycle 40% Ut 40% Ut during power mains interruptions, it is recommended that the NLX nano (60% dip in Ut) for 5 cycles be powered from an uninterruptible power supply or a battery. input lines IEC61000-4-11 70% Ut (30% dip in Ut) for 25 cycles <5% Ut (>95% dip in Ut) for 5 sec Power frequency (50/60Hz) 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. magnetic field IEC61000-4-8 NOTE: Ut is the a.c. mains voltage prior to application of the test level.

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English

Symbols

Guidance and manufacturer's declaration - electromagnetic immunity The NLX nano is intended for use in the electromagnetic environment specified below. The customer or the user of the NLX nano and manual should assure that it is used in such an environment. Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance Conducted RF 3Vrms 3Vrms Portable and mobile RF communications equipment should be used no closer to any part of the NLX nano, including cables, than the recommended separation distance IEC61000-4-6 150 kHz to 80MHz calculated from the equation applicable to the frequency of the transmitter. Radiated RF 3V/m 3V/m 80MHz to 2.5 GHz Recommended separation distance IEC61000-4-3 d = 1.2 P d = 1.2 P 80MHz to 800MHz d = 2.3 P 800MHz to 2.5GHz Where P is the maximum output power rating of the transmitter in watts (W)according to the transmitter manufacturer and d is the recommended separationdistance in meters (m). Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb, Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80MHz and 800MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobiles 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, an electromagnetic site survey should be considered. If the measured field strength in the location in which the NLX nano is used exceeds the applicable RF compliance level above, the NLX nano should be observed to verity normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the NLX nano. b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the NLX nano The NLX nano is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the NLX nano can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter Rated maximum output power of transmitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz W 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 separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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