
Full Digital Ultrasonic Diagnostic Instruments
User’s Manual V1.00
- 40 -
Table 3 - Guidance and manufacturer’s declaration—electromagnetic immunity
This equipment is intended for use in the electromagnetic environment specified below.
Customer or user shall assure that it is used in such an environment.
Immunity test
IEC60601 test
level
Compliance
level
Electromagnetic
environment-guidance
Voltage dips short
interruptions and
voltage variations
on power supply
input lines
IEC61000-4-11
<
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 cycles
<
5
%
U
T
(
>
95
%
dip in U
T
)
for 5 sec
<
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 cycles
<
5
%
U
T
(
>
95
%
dip in U
T
)
for 5 sec
Mains power quality shall be
that of a typical commercial or
hospital environment. If the
equipment requires continued
operation during power mains
interruptions, it is
recommended that this
equipment be powered from an
uninterruptible power supply.
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3 V
rms
150KHz to 80MHz
3 V/m
80MHz to 2.5GH
1V
rms
3V/m
Portable and mobile RF
communications equipment should
be used no closer to any part of this
equipment, including cables, than
the recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation distance
d
=
3.5√P
d
=
1.75√P
80MHz to 800MHz
d
=
2.33√P
800MHz to 2.5GHz
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 strength from fixed RF
transmitters, as determined by an
electromagnetic site survey,
a
should be less than the compliance
level in each frequency range.
b
Interference may occur in the
vicinity of equipment marked with
the following symbol:
Note 1:
U
T
is the a.c. mains voltage prior to application of the test level.
Note 2:
At 80MHz and 800MHz, the higher frequency range applies.
Note 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures objects and people.
a.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitter, an electromagnetic site survey should be
considered. If the measured field strength in the location in which this equipment is used
exceeds the applicable RF compliance level above, the equipment should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the equipment.
b.
Over the frequency range 150kHz to 80MHz, field strengths should be less than 1V/m.