Guidance And Manufacturer's Declaration- Electromagnetic Emissions; Guidance And Manufacturer's Declaration- Electromagnetic Immunity - Apex Pro-CARE Bariatric Manual De Uso

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Appendix A: EMC Information

Guidance and Manufacturer's Declaration- Electromagnetic Emissions:

This device is intended for use in the electromagnetic environment specified below. The user of this
device should make sure it is used in such an environment.
Emissions Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC61000-3-2
Voltage fluctuations /
Flicker emissions
IEC61000-3-3

Guidance and Manufacturer's Declaration- Electromagnetic Immunity:

This device is intended for use in the electromagnetic environment specified below. The user of this
device should make sure it is used in such an environment.
Immunity Test
Electrostatic Discharge (ESD)
IEC61000-4-2
Electrical fast transient/ burst
IEC61000-4-4
Surge
IEC61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC61000-4-11
Power frequency
(50/60Hz) magnetic field
IEC61000-4-8
NOTE: U
is the a.c. mains voltage prior to the application of the test level
T
Compliance
Electromagnetic Environment-Guidance
The device uses RF energy only for its internal function.
Group1
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment
Class B
The device is suitable for use in all establishments,
including domestic establishments and those directly
Class A
connected to the public low-voltage power supply
nethreerk
Complies
IEC60601
test
level
±6kV contact
±8kV air
±2kV for power supply
line
±1kV for input/out line
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
<5 % U
(>95 % dip in
T
U
)for 0,5 cycle
T
40 % U
(60 % dip in
T
U
)for 5 cycles
T
70 % U
(30 % dip in
T
U
)for 25 cycles
T
<5 % U
(>95 % dip in
T
U
)for 5 sec
T
3 A/m
Electromagnetic
Compliance
Environment-Guidance
Floors should be wood, concrete or
±6kV contact
ceramic tile. If floors are covered
±8kV air
with synthetic material, the relative
humidity should be at least 30 %.
±2kV for power supply
Mains power quality should be that
line
of atypical commercial or hospital
±1kV for input/out line
environment
± 1 kV line(s) to
Mains power quality should be that
line(s)
of atypical commercial or hospital
environment.
<5 % U
(>95 % dip in
Mains power quality should be that
T
U
) for 0,5 cycle
of atypical commercial or hospital
T
40 % U
(60 % dip in
environment. If the user of this
T
U
) for 5 cycles
device requires continued operation
T
70 % U
(30 % dip in
during power mains interruptions, it
T
U
) for 25 cycles
is recommended that the device be
T
<5 % U
(>95 % dip in
powered from an uninterruptible
T
U
) for 5 sec
power supply or a battery.
T
Power frequency magnetic fields
should be at levels characteristic of
3 A/m
atypical location in a typical
commercial or hospital
environment.
15

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