Guidance And Manufacturer’s Declaration - Electromagnetic Immunity - CareFusion AVEA Operating Instructions Manual

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238
Guidance and manufacturer's declaration - electromagnetic immunity
The AVEA Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the AVEA
Ventilator should assure that it is used in such an environment.
Immunity Test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
NOTE U
is the a.c. mains voltage prior to application of the test level.
T
Appendix J: Electromagnetic Declarations
60601-1-2 IEC:2001 (E) Table 202
IEC 60601
Test level
± 6 kV contact
± 8 kV air
± 6 kV for power supply
lines
± 1 kV for input/output lines
± 1 kV differential mode
± 2 kV common mode
<5 % U
T
(>95% dip in U
)
T
for 0,5 cycle
40 % U
T
(60 % dip in U
)
T
for 5 cycles
70 % U
T
(30 % dip in U
)
T
for 25 cycle
<5 % U
T
(>95% dip in U
)
T
for 5 seconds
3 A/m
Compliance level
± 6 kV contact
± 8 kV air
± 6 kV for power supply
lines
± 1 kV for input/output lines
± 1 kV differential mode
± 2 kV common mode
<5 % U
T
(>95% dip in U
)
T
for 0,5 cycle
40 % U
T
(60 % dip in U
)
T
for 5 cycles
70 % U
T
(30 % dip in U
)
T
for 25 cycle
<5 % U
T
(>95% dip in U
)
T
for 5 seconds
3 A/m
Operator's manual
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.
Compliance is dependent on the operator
following recommended charging and
maintenance of the installed battery backup.
Power frequency magnetic fields should be at
level characteristic of a typical location in a
typical commercial or hospital environment.
L2786 Rev. M

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