g.tec medical engineering GmbH
g.USBamp, USB Biosignal Amplifier: Instruction for use
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V2.16.09
Page 30
Guidance and manufacturer´s declaration
– electromagnetic immunity
The g.USBamp is intended for use in the electromagnetic environment specified below.
The customer or the user of the g.USBamp should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment -
guidance
Electrostatic discharge
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood,
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
all other < 3 m
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV differential
mode
± 2 kV common mode
± 1 kV differential
mode
± 2 kV common
mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
< 5 % U
T
(> 95 % dip in U
T
)
for ½ 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 s
< 5 % U
T
(> 95 % dip in U
T
)
for ½ 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 s
Mains power quality should be
that of a typical commercial or
hospital environment. If the
use of the g.USBamp requires
continued operation during
power mains interrupts, it is
recommended that the
g.USBamp be powered from
an uninterruptible power
supply or a battery.
Power frequency
(50 Hz/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE
U
T
is the a.c. mains voltage prior to application of the test level.
