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Appendix
Bluephase Style 20i is tested according to IEC 60601-1-2, Edition 3.0.
Medical electrical devices are subject to particular preventive actions according to EMC rules and must be installed and operated according
to the EMC guidelines in the accompanying documents.
Guidance and manufacturer‘s declaration – electromagnetic emission
The following tables are guidelines according to the 3rd edition of the medical standard IEC 60601-1-2.
Bluephase Style 20i is intended for use in the electromagnetic environment specified below. The customer or the user of Bluephase Style 20i
should assure that it is used in such an environment.
Table: According to IEC 60601-1-2, Edition 3.0
Emission test
Compliance
Electromagnetic environment - guidance
RF emissions CISPR 11
Group 1
Bluephase Style 20i 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
Bluephase Style 20i 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 purposes.
Harmonic emissions
IEC 61000-3-2
Class A
N/A
Voltage fluctuations / flicker
emissions IEC 61000-3-3
Complies
N/A
Guidance and manufacturer‘s declaration – electromagnetic immunity
Bluephase Style 20i is intended for use in the electromagnetic environment specified below. The customer or the user of Bluephase Style 20i
should assure that it is used in such an environment.
Table: According to IEC 60601-1-2, Edition 3.0
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should
be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV for power supply lines
± 1 kV for input/output lines
Mains power quality should be that of typical commercial
or dental environment.
Surge
IEC 61000-4-5
± 1 kV line - line
± 2 kV line - earth
± 1 kV line - line
no prot. earth
Mains power quality should be that of typical commercial
or dental environment.
Voltage dips,
short interrup-
tions and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
) for 0.5 cycle
40% U
T
(60% dip in U
T
) for 5 cycles
70% U
T
(30% dip in U
T
) for 25 cycles
<5% U
T
(>95% dip in U
T
) for 5 sec
<5% U
T
(>95% dip in U
T
) for 0.5 cycle
40% U
T
(60% dip in U
T
) for 5 cycles
70% U
T
(30% dip in U
T
) for 25 cycles
<5% U
T
(>95% dip in U
T
) for 5 sec
Mains power quality should be that of typical commercial
or dental environment. If the user of Bluephase Style 20i
requires continued operation during power mains inter-
ruptions, it is recommended that Bluephase Style 20i be
powered from an uninterruptible power supply or battery.
Power frequency
(50/60 Hz)
magnetic Field
IEC 61000-4-8
3 A/m
30 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
or dental environment.
