CapsoVision CapsoAccess CDAS3 Instructions For Use Manual page 10

Table 2 — Guidance and manufacturer' s declaration – electromagnetic immunity
The CapsoAccess® system is intended for use in the electromagnetic environment specified below.
The customer or the user of the CapsoAccess® system 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: UT is the a.c. mains voltage prior to application of the test level.
10
IEC 60601 test level
± 8 kV contact
± 15 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Voltage dips:
0% UT; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315°
0% UT; 1 cycle and 70% UT;
25/30 cycles
Single phase: at 0°
Voltage interruptions:
0% UT; 250/300 cycles
30 A/m
Compliance level
± 8 kV contact
± 15 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Voltage dips:
0% UT; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315°
0% UT; 1 cycle and 70% UT;
25/30 cycles
Single phase: at 0°
Voltage interruptions:
0% UT; 250/300 cycles
30 A/m
IFU-2800 Ref F 03/2020
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. lf the user of the
CapsoAccess® system requires continued
operation during power mains
interruptions, it is recommended that
the CapsoAccess® system be powered
from an uninterruptible power supply or
a battery.
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical domestic,
commercial or hospital environment.