Integra LifeSciences Mirror, DenLite Illuminate - Manual (Page 11)

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Authorized European Representative Address:
E.U. Representative
Miltex GmbH
78604 Rietheim-Weilheim/Germany
CB Scheme Certificate IEC 6060-1-1
Guidance and Manufacturer’s Declarations
Emissions for all EQUIPMENT and SYSTEMS
The REF DP5000 DenLite Illuminated Dental Mirror is intended for use in the electromagnetic
environment specified below. The customer or user of the DP5000 DenLite Illuminated Dental Mirror
should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF Emissions
CISPR 11 Group 1 The DP5000 DenLite Illuminated Dental Mirror 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
Harmonics
IEC 61000-3-2 N/A
Flicker
IEC 61000-3-3 N/A
The DP5000 DenLite Illuminated Dental Mirror are 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.
Immunity for all EQUIPMENT and SYSTEMS
The REF DP5000 DenLite Illuminated Dental Mirror is intended for use in the electromagnetic
environment specified below. The customer or user of the REF DP5000 DenLite Illuminated Dental
Mirror should assure that it is used in such an environment.
Immunity Test IEC 60601 Test
Level Compliance
Level Electromagnetic Environment -
Guidance
ESD
IEC 61000-4-2
± 6kV Contact
± 8kV Air ± 6kV Contact
± 8kV Air Floors should be wood, concrete, or
ceramic tile. If floors are synthetic
material, the relative humidity should
be at least 30%.
EFT
IEC 61000-4-4
±2kV Mains
±1kV I/O N/A Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kV Differential
±2kV Common N/A Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage Dips,
short interruptions,
and voltage
variations on
power supply input
lines.
IEC 61000-4-11 >95% Dip in 0.5
Cycle
60% Dip in 5
Cycles
30% Dip for 25
Cycles
>95% Dip in 5
Seconds N/A Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the REF
DP5000 DenLite Illuminated Dental
Mirror requires continued operation
during power mains interruptions, it
is recommended that the REF
DP5000 DenLite Illuminated Dental
Mirror be powered from an
uninterruptible power supply or
battery.
Power Frequency
50/60Hz
Magnetic Field
IEC 61000-4-8
3 A/m N/A Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.