Guidance And Manufacturer's Declaration - Electromagnetic Immunity - Ivoclar Vivadent Bluephase G4 Instrucciones De Uso

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.
Emission test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations / flicker
emissions IEC 61000-3-3
Table: According to IEC 60601-1-2
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.
Immunity test IEC 60601 test level
Electrostatic ± 6 kV contact
discharge (ESD) ± 8 kV air
IEC 61000-4-2
Electrical fast ± 2 kV for power supply lines
transient/burst ± 1 kV for input/output lines
IEC 61000-4-4
Surge ± 1 kV line - line
IEC 61000-4-5 ± 2 kV line - earth
Voltage dips, <5% U
T
short interrup- (>95% dip in U
tions and voltage
40% U
T
variations on
(60% dip in U
power supply
70% U
input lines
T
(30% dip in U
IEC 61000-4-11
<5% U
T
(>95% dip in U
Power frequency 3 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
Table: According to IEC60601-1-2
NOTE: U is the a.c. mains voltage prior to application of the test level.
T
110
Compliance Electromagnetic environment - guidance
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.
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.
Class A N/A
Complies N/A
Compliance level
± 6 kV contact
± 8 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV line - line
no prot. earth
<5% U
T
) for 0.5 cycle (>95% dip in U
T
40% U
T
) for 5 cycles (60% dip in U
T
70% U
T
) for 25 cycles (30% dip in U
T
<5% U
T
) for 5 sec (>95% dip in U
T
30 A/m
Electromagnetic environment - guidance
Floors should be 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 typical commercial
or dental environment.
Mains power quality should be that of typical commercial
or dental environment.
Mains power quality should be that of typical commercial
) for 0.5 cycle or dental environment. If the user of Bluephase G4 requires
T
continued operation during power mains interruptions,
it is recommended that Bluephase G4 be powered from an
) for 5 cycles
T
uninterruptible power supply or battery.
) for 25 cycles
T
) for 5 sec
T
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
or dental environment.