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Guidance and manufacturer's declaration - electromagnetic immunity

The Varios560 / Varios560LUX is intended for use in the electromagnetic environment specified below. The customer or the user of the Varios560 / Varios560LUX 
should assure that it is used in such an environment.

NOTE:

Ut is the a.c. mains voltage prior to application of the test level.

Immunity test

IEC60601 test level

Electromagnetic environment - guidance

Electrostatic discharge (ESD)
IEC61000-4-2

Electrical fast transient/burst
IEC61000-4-4

Surge
IEC61000-4-5

Voltage dips, short 
interruptions and voltage 
variations on power supply 
input lines
IEC61000-4-11

Power frequency
(50/60Hz)
magnetic field
IEC61000-4-8

±6kV contact
±8kV air

±2kV for power supply lines
±1kV for input/output

±1kV line(s) to line(s)
±2kV line(s) to earth

<5% Ut
(>95% dip in Ut) for 0.5 cycle

40% Ut
(60% dip in Ut) for 5 cycles

70% Ut
(30% dip in Ut) for 25 cycles

<5% Ut
(>95% dip in Ut) for 5 secs

3 A/m

Compliance level

±6kV contact
±8kV air

±2kV for power supply lines
±1kV for input/output

±1kV line(s) to line(s)
±2kV line(s) to earth

<5% Ut
(>95% dip in Ut) for 0.5 cycle

40% Ut
(60% dip in Ut) for 5 cycles

70% Ut
(30% dip in Ut) for 25 cycles

<5% Ut
(>95% dip in Ut) for 5 sec

3 A/m

Floors should be wood, concrete or ceramic tile. If floors are 
covered with synthetic material, the relative humidity should 
be at least 30%.

Mains power quality should be that of a typical commercial or 
hospital environment.

Mains power quality should be that of a typical commercial or 
hospital environment.

Mains power quality should be that of a typical commercial or 
hospital environment. If the user of the 
Varios560 / Varios560LUX requires continued operation 
during power mains interruptions, it is recommended that the 
Varios560 / Varios560LUX be powered from an 
uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels 
characteristic of a typical location in a typical commercial or 
hospital environment.

Guidance and manufacturer's declaration - electromagnetic immunity

The Varios560 / Varios560LUX is intended for use in the electromagnetic environment specified below. The customer or the user of the Varios560 / Varios560LUX 
should assure that it is used in such an environment.

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 Varios560 / Varios560LUX is used exceeds the 
applicable RF compliance level above, the Varios560 / Varios560LUX should be observed to verity normal operation. If abnormal performance is observed, additional 
measures may be necessary, such as reorienting or relocating the Varios560 / Varios560LUX.

b  Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.

Immunity test

IEC60601 test level 

Electromagnetic environment - guidance

Conducted RF
IEC61000-4-6

Radiated RF
IEC61000-4-3

3Vrms
150 kHz to 80MHz

3V/m
80MHz to 2.5 GHz

Compliance level 

3Vrms

3V/m

Portable and mobile RF communications equipment should be used no 
closer to any part of the Varios560 / Varios560LUX, including cables, 
than the recommended separation distance calculated from the 
equation applicable to 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 2.5GHz

Where

P

 is the maximum output power rating of the transmitter in 

watts (W) according to the transmitter manufacturer and 

d

 is the 

recommended separation distance in meters (m).
Field strengths from fixed RF transmitters as determined by an 
electromagnetic site survey, should be less than the compliance level 
in each frequency range.
Interference may occur in the vicinity of equipment marked with the 
following symbol:

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

150kHz to 80MHz

d

 =1.2

P

Recommended separation distances between portable and mobile RF communications equipment and the Varios560 / Varios560LUX

Complies with

RF emissions, CISPR11,

Harmonic emissions,

Voltage fluctuations/ flicker emission,

Electrostatic discharge (ESD)

Electric fast transient / burst

Surge

Voltage dips, short interruptions and voltage variations on power 
supply input lines

Power frequency(50/60Hz) magnetic field

Conducted RF

Radiated RF

Maximum length

2.0 m

2.5 m

Shield

Unshielded

Unshielded

Cables and accessories

Handpiece cord

Foot Controler

The Varios560 / Varios560LUX is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of 
the Varios560 / Varios560LUX can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications 
equipment (transmitters) and the Varios560 / Varios560LUX as recommended below, according to the maximum output power of the communications equipment.

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.

Rated maximum output power of transmitter

W

0.01

800MHz to 2.5GHz

d

 =2.3

P

80MHz to 800MHz

d

 =1.2

P

0.12

0.23

0.12

0.1

0.38

0.73

0.38

1

1.2

2.3

1.2

10

3.8

7.3

3.8

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.

100

12

23

12

Separation distance according to frequency of transmitter

m

Class B/ Group 1

IEC61000-3-2

IEC61000-3-3

IEC61000-4-2

IEC61000-4-4

IEC61000-4-5

IEC61000-4-11

IEC61000-4-8

IEC61000-4-6

IEC61000-4-3

Содержание Varios 560

Страница 1: ...read this Operation Manual carefully before use and file for future reference Multi Function Ultrasonic Scaler OM E0248E 004 10 03 01 S The EU directive 93 42 EEC was applied in the design and production of this medical device ...

Страница 2: ...evice Safety instructions are classified as follows in accordance with the seriousness of the risk Use by medical professional such as doctor or dental hygienist is intended Do not unplug the Power Cord with wet hands to avoid electric shock Be sure to prevent water on the Control Unit because it may result in short circuit and electric shock Do not allow any impacton the Control Unit Do not drop T...

Страница 3: ...on and overheating outside the patient s oral cavity before use If any abnormalities are found stop using immediately and contact your dealer Should this products function abnormally cease operation immediately and returen it to the dealer for repair Do not force or pull on Power Cord and or Handpiece Cord It could cause disconnection Be sure to attach NSK genuine tips when using NSK Varios ultras...

Страница 4: ... Control Plug Water Filter Case Water Filter Case Water Tube Water Tube Water Connector Water Connector 4 Handpiece Cord Connection Align the marks on the Control Unit and the Handpiece Cord Plug Gently push the Plug into the Connector CAUTION 1 Water System Setup Carefully check all Water Supply Connections prior to starting procedure Open the dental unit s water valve Set water pressure between ...

Страница 5: ...urface can be injured 2 Set the Power Level with the Power Level Key on the Front Panel The lamps in the Power Display Panel will indicate the selected power level Check to make sure the Power Level is set in the appropriate range for the selected Tip Fig 12 NOTICE Continuous pushing of the Power Level Key will cause the Power Level Display to climb When only water is desired without oscillating t...

Страница 6: ...lly by an object etc beeping starts to call attention To reset the alarm Release the Foot Control remove the object etc To enter new settings After confirming the settings of Water Mode Power Setting and Operating Mode push the memory key for approx 2 seconds The memory light will illuminate The old memory is cleared and new settings are programmed Memory Key Memory Lamp When the Tip is mounted to ...

Страница 7: ...p replacement is not necessary Yellow Wear of 1mm Tip is showing some wear Tip replacement is recommended Red Wear of 2mm Tip is badly worn Tip replacement is necessary Fig 20 OK NO Tip Card Handpiece Neck The Tip Card can be used to check the following tips G1 G4 G5 G6 G8 P1 P1D P10 and P20 Efficiency 1mm 2mm 25 50 Decrease Decrease 2 Changing Water Filter 1 Close the water valve of the dental uni...

Страница 8: ...oting No Poor vibration The tip is bent or broken The tip walks out Noise from the handpiece The handpiece is overheating The Power Lamp does not light even if the Power Switch is ON The tip does not generate vibration in spite of depressing the Foot Control The Power Cord or the Jack is disconnected The internal Fuse has burned out The tip is not tightened firmly Worn Tip Output has not been corre...

Страница 9: ... turns on and off Tip oscillates but light does not turn on Lamp is correctly and securely mounted in the socket but light does not turn on Power output is set at maximum at G mode Continuous operation for a long time at high mode G General Operation in a high temperature room Beeping while power on Beeping while stopping vibration of Tips The Water Adjustment Dial is closed Disconnected irrigatio...

Страница 10: ... measures may be necessary such as reorienting or relocating the Varios560 Varios560LUX b Over the frequency range 150kHz to 80MHz field strengths should be less than 3 V m Immunity test IEC60601 test level Electromagnetic environment guidance Conducted RF IEC61000 4 6 Radiated RF IEC61000 4 3 3Vrms 150 kHz to 80MHz 3V m 80MHz to 2 5 GHz Compliance level 3Vrms 3V m Portable and mobile RF communicat...

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