Electromagnetic Emissions Declarations - Boston Scientific EKOS Control System 4.0 User Manual

Electromagnetic Emissions Declarations

Table 7.
Guidance and manufacturer's declaration – electromagnetic emissions
The Control Unit is intended for use in the electromagnetic environment specified below� The customer or the user of the Control Unit
should assure that it is used in such an environment�
Emissions text Compliance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Table 8.
Guidance and manufacturer's declaration – electromagnetic immunity
The Control Unit is intended for use in the electromagnetic environment specified below� The customer or the user of the Control Unit
should assure that it is used in such an environment�
IMMUNITY test IEC 60601 test level
Electrostatic ± 8 kV contact
discharge (ESD)
IEC 61000-4-2 ± 15 kV air
Electrical fast ± 2 kV for power
transient/burst supply lines
IEC 61000-4-4
± 1 kV for input/output
lines
Surge ± 1 kV line(s) to
IEC 61000-4-5 line(s)
± 2 kV line(s) to earth
Voltage dips, short <5 % U
interruptions and (>95 % dip in U
voltage variations for 0,5 cycle
on power supply
input lines 40 % U
IEC 61000-4-11 (60 % dip in U
for 5 cycles
70 % U
(30 % dip in U
for 25 cycles
<5 % U
(>95 % dip in U
for 5 s
Group 2
Class A
Class A
Complies
Compliance level
± 8 kV contact
± 15 kV air
± 2 kV for power
supply lines
Not Applicable
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
<5 % U
T T
) (>95 % dip in U
T
for 0,5 cycle
40 % U
T T
(60 % dip in U
)
T
for 5 cycles
70 % U
T T
) (30 % dip in U
T
for 25 cycles
<5 % U
T T
) (>95 % dip in U
T
for 5 s
Electromagnetic environment - guidance
The Control Unit must emit electromagnetic energy in order to
perform its intended function� Nearby electronic equipment may
be affected�
The Control Unit is suitable for use in all establishments other
than domestic, and may be used in domestic establishments and
those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes,
provided the following warning is heeded:
Warning: This equipment/system is intended for use by
healthcare professionals only� This equipment/ system may
cause radio interference or may disrupt the operation of nearby
equipment� It may be necessary to take mitigation measures,
such as re-orienting or relocating the Control Unit or shielding the
location�
Electromagnetic environment - guidance
Floors should be wood, 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 a typical
commercial or hospital environment�
Mains power quality should be that of a typical
commercial or hospital environment
Mains power quality should be that of a typical
commercial or hospital environment� If the user of the
T)
Control Unit requires continued operation during power
mains interruptions, it is recommended that the internal
battery in the Control Unit be properly maintained
) and charged�
T
)
T
)
T
17
Black (K) ∆E ≤5.0