Ivoclar Vivadent Bluephase G4, Инструкция по эксплуатации, Страница: 182 / 184

182
Appendix
Bluephase G4 is EMC-tested in conformity with the requirements of IEC 60601-1-2:2007 3th (see the following tables) and IEC 60601-1-2:2014
4th Edition (according clause 7 and 8.9, tables 4 to 9). Bluephase G4 is a medical device that requires special safety precautions and must be
installed and placed in operation in accordance with the attached EMC information.
Warning
Portable wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations,
walki-talkie etc. can affect the Bluephase G4 and should be kept at least a distance of 30 cm (12 inches) to any part of Bluephase G4.
Guidance and manufacturer‘s declaration – electromagnetic emission
The following tables are guidelines according to the medical standard IEC 60601-1-2.
Bluephase G4 is intended for use in the electromagnetic environment specified below. The customer or the user of Bluephase G4 should assure that
it is used in such an environment.
Table: According to IEC 60601-1-2
Emission test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1 Bluephase G4 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 G4 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 G4 is intended for use in the electromagnetic environment specified below. The customer or the user of Bluephase G4 should assure that
it is used in such an environment.
Table: According to IEC60601-1-2
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 G4 requires
continued operation during power mains interruptions,
it is recommended that Bluephase G4 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.