Mindray BeneFusion VP5 - Page 89

B-3
If the device is operated within the electromagnetic environment listed in Table
Guidance and Declaration —Electromagnetic Immunity, the system will remain
safe and provide the following essential performance:
 Operating mode
 Accuracy
 Function
 Protection against UNINTENDED BOLUS volumes
 Occlusion
 ALARM CONDITIONS regarded
 Data stored
Guidance and Declaration - Electromagnetic Immunity
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device 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
±8 kV contact
±15kV air
±8 kV contact
±15kV 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
±2 kV for power
supply lines
±1 kV for
input/output lines
(length greater
than 3 m)
±2 kV for power
supply lines
±1 kV for
input/output lines
(length greater
than 3 m)
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
Voltage dips
and Voltage
interruptions
IEC 61000-4-11
0 % U
T
for 0,5
cycle
0 % U
T
for 1 cycle
and 70 % U
T
for
25/30 cycles
0 % U
T
for 250/300
cycle
0 % U
T
for 0,5
cycle
0 % U
T
for 1 cycle
and 70 % U
T
for
25/30 cycles
0 % U
T
for 250/300
cycle
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of our product
requires continued
operation during power
mains interruptions, it is
recommended that our
product be powered
from an uninterruptible