9
If the above steps do not solve the problem, contact the dealer or point of purchase. DO NOT USE THE
SmartLite
®
Max Light AND DO NOT ATTEMPT TO SERVICE THE UNIT. Serious injury may result.
SmartLite
®
Max L.E.D. Curing Light complies with the following Directives/Standards:
• Medical electrical equipment Part 1: General requirements for safety (IEC 60601-1)
• Standard for Safety for Medical Electrical Equipment, Part 1: General Requirements for Safety (UL 60601-1
and CAN/CSA C22.2 No. 601.1-M90)
• Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard:
Programmable Electrical Medical Systems Consolidated (IEC 60601-1-4)
Electromagnetic Compatibility
• This information is required by the 3rd edition of IEC 60601-1-2.
• The SmartLite
®
Max Light needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided in this manual.
• Portable and mobile RF communications equipment can affect the SmartLite
®
Max Light.
• The use of accessories, transducers and cables other than those specified by DENTSPLY Caulk, may result
in increased emissions or decreased immunity of the SmartLite
®
Max Light.
• The SmartLite
®
Max Light should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the SmartLite
®
Max Light should be observed to verify normal
operation in the configuration in which it will be used.
Guidance and manufacturer’s declaration – electromagnetic emissions
The SmartLite
®
Max Light is intended for use in the electromagnetic environment specified below.
The customer or user of the light should assure that it is used in such an environment.
Emissions Test
Compliance
RF emissions CISPR 11
Group 1
The SmartLite
®
Max Light 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 emissions CISPR 11
Class B
Harmonic emissions IEC 61000-3-2
Not available
Voltage Fluctuations/Flicker emissions
Not available
The SmartLite
®
Max Light is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes.
Guidance and manufacturer’s declaration – electromagnetic immunity
The SmartLite
®
Max Light is intended for use in the electromagnetic environment specified below.
The customer or user of the light should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Electrostatic discharge
±6 kV contact
±6 kV contact
Floors should be wood, concrete or ceramic tile. If floors
(ESD) IEC 61000-4-2
±8 kV air
±8 kV air
are covered with synthetic material, the relative humidity
should be at least 30%.
Electrical fast transient/
±2 kV for power supply lines ±2 kV for power supply lines Mains power quality should be that of a typical commercial
burst IEC 61000-4-4
±1 kV for input/output lines
Not Applicable
or hospital environment.
Surge IEC 61000-4-5
±1 kV differential mode
±1 kV differential mode
Mains power quality should be that of a typical commercial
±2 kV common mode
±2 kV common mode
or hospital environment.
Voltage dips, short
<5% UT (>95% dip in UT)
<5% UT (>95% dip in UT)
Mains power quality should be that of a typical commercial
interruptions and
for 0,5 cycles
for 0,5 cycles
or hospital environment. If the user of the SmartLite
®
Max
voltage variations on
40% UT (60% dip in UT)
40% UT (60% dip in UT)
Light requires continued operation during power mains
power supply input
for 5 cycles
for 5 cycles
interruptions, it is recommended that the SmartLite
®
Max
lines IEC 61000-4-11
70% UT (30% dip in UT)
70% UT (30% dip in UT)
Light be powered from an uninterruptible power supply
for 25 cycles
for 25 cycles
or a battery.
<5% UT (>95% dip in UT)
<5% UT (>95% dip in UT)
for 5 sec
for 5 sec
(50/60 Hz) magnetic
3 A/m
3 A/m
Power frequency magnetic fields should be at levels
field IEC 61000-4-8
characteristic of a typical location in a typical commercial
or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
