Invacare® Softform Active® 2 Rx
Electromagnetic immunity
Immunity test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
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
Immunity test
IEC 60601 test level
Conducted RF
3 V
rms
150 kHz to 80 MHz
IEC 61000-4-6
6 V
rms
Radiated RF
10 V/m
IEC 61000-4-3
80 MHz to 2.7 GHz
385MHz - 5785MHz
Test specifications
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communication
equipment (Refer
to table 9 of IEC
60601-1-2:2014)
18
IEC 60601 test level
Compliance level
±8 kV contact
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±2 kV, ±4 kV, ±8 kV,
±15 kV air
±15 kV air
±2 kV for power supply
±2 kV for power supply
lines
lines
±1 kV for Input/output
±1 kV for
lines
interconnecting cable
± 1 kV line to line
±1 kV line to line
± 2 kV line to earth
<5% U
(>95% dip in
<5% U
T
U
)
U
T
for 0.5 cycle
for 0.5 cycle
40% U
(60% dip in U
)
40% U
T
T
for 5 cycles
for 5 cycles
70% U
(30% dip in U
)
70% U
T
T
for 25 cycles
for 25 cycles
<5% U
(>95% dip in
<5% U
T
U
)
U
T
for 5 sec
for 5 sec
30 A/m
30 A/m
Compliance level
3 V
rms
150 kHz to 80 MHz
in ISM bands
6 V
rms
10 V/m
80 MHz to 2.7 GHz
385MHz - 5785MHz
Test specifications
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communication
equipment (Refer
to table 9 of IEC
60601-1-2:2014)
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.
(>95% dip in
Mains power quality should be that of a
T
)
typical commercial or hospital environment.
T
If the user of the device requires continued
operation during power mains interruptions, it is
(60% dip in U
)
T
T
recommended that the device be powered from
an uninterruptible power supply or a battery.
(30% dip in U
)
T
T
(>95% dip in
T
)
T
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Electromagnetic environment – guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the CT515,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:
d = [3.5/V
in ISM bands
d = 1.12 x √P 80 MHz to 800 MHz
d = 2.3 x √P 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
be less than the compliance level in each frequency
range
b)
.
Interference may occur in the vicinity of equipment
marked with the following symbol:
] x √P
1
a)
, should
1630000-D