13. 1 ELECTROMAGNETIC EMISSIONS
P
IEZOTOME
2 is intended for use in the electromagnetic environment specified in the table below. The
user and/or installer must ensure that the P
IEZOTOME
2 is used in such an environment.
Emission test
Compliance
Electromagnetic environment - guidance
RF emission - CISPR
11.
Group 1
P
IEZOTOME
2 uses RF energy for internal operation.
Therefore, its radiofrequency emissions are very low and are not
likely to cause any interference in nearby equipment.
RF emission - CISPR
11.
Class A
P
IEZOTOME
2 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 current
emission
IEC 61000-3-2.
Class A
Voltage fluctuation
and flicker
IEC 61000-3-3.
Complies
13. 2 ELECTROMAGNETIC IMMUNITY
P
IEZOTOME
2 is intended for use in the electromagnetic environment specified in the table below. The
user and/or installer must ensure that the device is used in such an electromagnetic environment.
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 must be wood, concrete, cement or
tiled.
If floors are covered with synthetic
material (carpet, etc.), the relative
humidity must be at least 30%.
Electrical fast
transients
IEC 61000-4-4.
± 2KV for power
supply lines
± 2KV for power
supply lines
Mains power quality should be that of a
typical commercial or hospital
environment (hospital, clinic).
Surges
IEC 61000-4-5.
± 1KV
differential
mode ± 2KV
common mode
± 1KV
differential
mode ± 2KV
common mode
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
IEC 61000-4-11.
<5% U
T
(>95% dip
in U
T
) for 0.5
cycles.
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 250
cycles
<5% U
T
(>95% dip
in U
T
) for 0.5
cycles.
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 250
cycles
Mains power quality should be that of a
typical commercial or hospital
environment.
If the use of the P
IEZOTOME
2 requires
continued operation during power mains
interruption, it is recommended that the
product be powered from a separate power
supply (UPS, etc.).
Summary of Contents for Satelec Implant Center 2
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