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13. Annex I – EMC statement and guidelines
Guidance and manufacturer’s declaration – electromagnetic immunity
The Cryomatic is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in
such an environment.
Immunity test
IEC 60601 Test level
Compliance level
Electromagnetic environment - guidance
Electrostatic
discharge (ESD).
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst.
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV for power supply lines
± 1 kV for input/output lines
Mains power quality should be that of a typical commercial
or hospital environment.
Surge.
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
N/A
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%
U
T
(> 95% dip in
U
T
) for 0.5 cycles
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 cycles
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 s
Mains power quality should be that of a typical commercial or
hospital environment.
If the user of the Cryomatic requires continued operation
during power mains interruptions, it is recommended that the
instrument be powered from an uninterruptible power supply
or battery.
Power frequency
(50/60 Hz) magnetic
field. IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
Note
U
T
is the a.c. mains voltage prior to application of the test level.
