biodex ATOMLAB 960 - Immunity Declaration

ATOMLAB 960 MEDICAL SPECTROMETER APPENDIX C C-3
IMMUNITY
Manufacturer’s declaration electromagnetic immunity
The Atomlab 960 Thyroid Uptake System is intended for use in the electromagnetic environment specified
below. The customer or the user of the Atomlab 960 Thyroid Uptake System should assure that it is used
in such an environment.
Immunity
Test
IEC 60601-1-2
Test Level
IEC 60601-1-2
Compliance Level
Electromagnetic
Environment Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
Contact ± 6 kV
Air ± 8 kV
Floor should be wood, concrete or
ceramic tiles. If floor is covered with
synthetic material, the relative
humidity should be at least 30%
Electrical fast
transients/burst
IEC 61000-4-4
± 2 kV for power lines
± 1 kV for input/output
Lines
Power ± 2 kV
Signal ± 1 kV
Mains power quality should be that of
a typical commercial or hospital
environment
Surge
IEC 61000-4-5
± 1 kV differential
mode
± 2 kV common mode
± 1 kV diff. mode
± 2 kV com. mode
Mains power quality should be that of
a typical commercial or hospital
environment
Voltage dips,
short interruptions
and voltage
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 UT) 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 UT) for 5 sec
Mains power quality should be that of
a typical commercial or hospital
environment. If a better mains power
quality is required, it is recommended
that the Atomlab 960 Thyroid Uptake
System 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 Atomlab
960 Thyroid Uptake System display
further from sources of power
frequency magnetic fields or to
install magnetic shielding. The power
frequency magnetic field should be
measured in the intended installation
location to assure that it is
sufficiently low