Ivoclar Vivadent Bluephase PowerCure Instrucciones De Uso página 122

Appendix
Bluephase PowerCure 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 PowerCure 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 PowerCure and should be kept at least a distance of 30 cm (12 inches) to any
part of Bluephase PowerCure.
Guidance and manufacturer's declaration – electromagnetic emission
The following tables are guidelines according to the medical standard IEC 60601-1-2.
Bluephase PowerCure is intended for use in the electromagnetic environment specified below. The customer or the user of
Bluephase PowerCure 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 PowerCure is intended for use in the electromagnetic environment specified below. The customer or the user of
Bluephase PowerCure 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
122
Compliance Electromagnetic environment - guidance
Group 1 Bluephase PowerCure 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 PowerCure 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
) for 0.5 cycle commercial or dental environment. If the user
T
of Bluephase PowerCure requires continued
operation during power mains interruptions,
) for 5 cycles
T
it is recommended that Bluephase PowerCure
be powered from an uninterruptible power
) for 25 cycles
supply or battery.
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.