biodex BioSway - Page 74

CONTENTS
— E-3 — APPENDIX E
*Reference test results for details
Immunity test
IEC 60601-1-2
Test level
IEC 60601-1-2
Compliance level
Electromagnetic environment – guidance
Voltage dips, short
i
nterruptions and
v
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ge variations on
power supply input
lines
IEC 61000-4-11
<
5% UT (> 95% of dip in
UT) for 1/2 cycle
40% UT (60% of dip in
UT) for 5 cycle
70% UT (30% of dip in
UT) for 25 cycle
< 5% UT (> 95% of dip in
U
T) for 5 sec
<
5% UT (> 95% of dip
in UT) for 1/2 cycle
40% UT (60% of dip
in UT) for 5 cycle
70% UT (30% of dip
in UT) for 25 cycle
< 5% UT (> 95% of dip in
U
T) for 5 sec *
Mains power quality should be that of a typical
c
ommercial or hospital environment. If a
b
etter
m
ains power quality is requir
e
d, it is
recommended that the BioSway Balance is
powered from an uninterruptible power supply
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m
3 A/m
If image distortion occurs, it may be necessary
to position the BioSway display further from
sources of power frequency magnetic fields or
t
o install magnetic shielding. The power
f
requency magnetic field should be measured in
the intended installation location to assure that it
is sufficiently low
Conducted RF
IEC 61000-4-6
3 Vrms,
150 KHz to 80 MHz
3 Vrms,
150KHz to 80 MHz
Radiated RF
I
EC 61000
-4-3
3 V/m,
8
0 MHz
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2.5
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3 V/m,
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0 MHz
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o2.
5
GHz
See Risk Analysis
Report *
Portable and mobile RF communications
equipment should be used no closer to any part
of the BioSway Balance, including cables, than
the recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:
d = 1.2! P 150 KHz to 80 MHz
d = 1.2! P 80 MHz to 800 MHz
d = 2.3! P 800 MHz to 2.5 GHz
where P is the maximum output power rating of
the transmitter in watt (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.
b
Interference may occur in the vicinity of
equipment marked with the following symbol:
Note 1. UT is the a.c. mains voltage prior to application of the test level.
Note 2. At 80 MHz and 800 MHz, the higher frequency range applies.
Note 3 . These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflections
from structures, objects and people
a
Field strength from mixed transmitters, such as base stations for radio telephones and land mobile radios, amateur radio, AM
or FM 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 BioSway Balance is used exceeds the applicable RF compliance levels above, the BioSway Balance should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the BioSway Balance system.
b
Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
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