CareFusion AVEA - Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

238 Appendix J: Electromagnetic Declarations Operator's manual
L2786 Rev. M
60601-1-2 IEC:2001 (E) Table 202
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
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 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
± 6 kV for power supply
lines
± 1 kV for input/output lines
± 6 kV for power supply
lines
± 1 kV for input/output lines
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 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
<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
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 (50/60
Hz) magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields should be at
level 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.