IC Medical CRYSTAL VISION 450D Operating And Installation Manual page 36

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CRYSTAL VISION
Model 450D is intended for use in the electromagnetic environment specified below. The user of the CRYSTAL VISION
Model 450D should assure that the CRYSTAL VISION
IEC 60601-1-2 Requirements:
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
UT=230 Vac
Power frequency (50 Hz)
magnetic field.
IEC 61000-4-8
Conducted RF
IEC 61000-4-6
Radiated RF
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 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 transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location
in which the 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 re-orienting or relocating the equipment
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Declaration for Electromagnetic Immunity
®
Model 450D is used in such environment.
IEC 60601-1-2 Test Level
± 6kv contact 8kv air
± 2kv for power supply lines ± 1kv
for input/output lines
± 1kv line(s) to line(s) ± 2kv line(s)
to earth
<5% UT (>95% dip in UT) for 0.5
cycle
40% UT (60% dip in UT) for 5
cycles
70% UT (30% dip in UT for 25
cycles
<5% UT (>95% dip in UT for 5 sec
3 A/m
3Vrms
Compliance
Electromagnetic environment - guidance
Level
Full compliance
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should
be at least 30%.
Full compliance
Mains power quality should be that of a typical commercial or
hospital environment.
Full compliance
Mains power quality should be that of a typical commercial or
hospital environment.
Full compliance
Mains power quality should be that of a typical commercial or
hospital environment. If the user of the equipment requires
continued operations during power mains interruptions, it is
recommended that the equipment be powered from an
uninterruptible power supply or a battery.
Full compliance
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
Portable and mobile RF communications equipment should be
Full compliance
used no closer to any part of the equipment including cables,
than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
3,5
��
��1
,
��
��
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
a
should be less than the compliance level in each
frequency range
Interference may occur in the vicinity of known RF
transmitting devices and equipment marked with the
following symbol:
29
√��
√ ��
80 MHz to 800 MHz
√ ��
800 MHz to 2,5 GHz
b
.
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