Immunity test
EN 60601
test level
Compliance level
Electromagnetic
environment -
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC61000-4-11
dips
0 %Ut: 0.5 cycle
(0,45,90,135,180,225,270
and 315 degree)
0 %Ut: 1 cycle
(0 degree)
70 %Ut: 25/30 cycles
(0 degree)
short interruptions
0 %Ut: 250/300 cycles
Ut: Rated voltage of EUT
dips
0 %Ut: 0.5 cycle
(0,45,90,135,180,225,270
and 315 degree)
0 %Ut: 1 cycle
(0 degree)
70 %Ut: 25/30 cycles
(0 degree)
short interruptions
0 %Ut: 250/300 cycles
Ut: Rated voltage of EUT
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
BELRAY
II MODEL 097
x-ray
requires continued operation during
power mains interruptions, it is
recommended that the BELRAY II
MODEL 097 x-ray be powered
from an uninterruptible power
supply or a battery.
Conducted RF
IEC61000-4-6
AC/DC power and Signal
input/output
0.15 MHz - 80 MHz: 3V
6 V in ISM bands
between 0.15 MHz - 80
MHz (unmodulated, r.m.s.)
80 % AM (1 kHz)
AC/DC power and Signal
input/output
0.15 MHz - 80 MHz: 3V
6 V in ISM bands
between 0.15 MHz - 80
MHz (unmodulated, r.m.s.)
80 % AM (1 kHz)
Portable RF communications
equipment (including peripherals
such as antenna cables and external
antennas) should be used no closer
than 30cm (12 inches) to any part
of the BELRAY II MODEL 097,
including cables specified by the
manufacturer. Otherwise,
degradation of the performance of
this equipment could result.
Radiated RF
IEC61000-4-3
80 MHz - 2700 MHz:
3V/m
(unmodulated, r.m.s.)
80 % AM (1kHz)
80 MHz - 2700 MHz:
3V/m
(unmodulated, r.m.s.)
80 % AM (1kHz)
Proximity fields
from RF wireless
communication
equipment
IEC61000-4-3
385 MHz 27 V/m
(unmodulated, r.m.s.)
Pulse modulation 18 Hz
385 MHz 27 V/m
(unmodulated, r.m.s.)
Pulse modulation 18 Hz
450 MHz 28 V/m
(unmodulated, r.m.s.)
FM ± 5 kHz deviation
1 kHz sine or Pulse
modulation 18 Hz
450 MHz 28 V/m
(unmodulated, r.m.s.)
FM ± 5 kHz deviation
1 kHz sine or Pulse
modulation 18 Hz
710 MHz, 745 MHz,
780 MHz
9 V/m (unmodulated, r.m.s.)
Pulse modulation 217 Hz
710 MHz, 745 MHz,
780 MHz
9 V/m (unmodulated, r.m.s.)
Pulse modulation 217 Hz
810 MHz, 870 MHz,
930 MHz
28 V/m (unmodulated,
r.m.s.)
Pulse modulation 18 Hz
810 MHz, 870 MHz,
930 MHz
28 V/m (unmodulated,
r.m.s.)
Pulse modulation 18 Hz
1720 MHz, 1845 MHz,
1970 MHz
28 V/m (unmodulated,
r.m.s.)
Pulse modulation 217 Hz
1720 MHz, 1845 MHz,
1970 MHz
28 V/m (unmodulated,
r.m.s.)
Pulse modulation 217 Hz
2450 MHz 28 V/m
(unmodulated, r.m.s.)
Pulse modulation 217 Hz
2450 MHz 28 V/m
(unmodulated, r.m.s.) Pulse
modulation 217 Hz
5240 MHz, 5500 MHz,
5785 MHz
9 V/m (unmodulated, r.m.s.)
5240 MHz, 5500 MHz,
5785 MHz
9 V/m (unmodulated, r.m.s.)
4. Essential performance
Unless the exposure switch is pressed, x-ray is not exposed.
If the Essential performance is lost or deteriorated, the device may operate inadvertently and may
harm the patient, the operator, and the surrounding people.
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