Spectros Medical Devices Inc.
Page 39 of 44
Rev B
T-STAT 2.0 User Manual
Table 2
Guidance and
manufacturer’s declaration –
electromagnetic immunity
The T-Stat® 2.0 is intended for use in the electromagnetic environment specified below. The customer or the user of
the T-Stat®2.0 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
differential
mode
± 2 kV
common 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 %
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 s
<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 s
Mains power quality should be that of a typical
commercial or hospital environment. If the user of the T-
Stat®2.0 requires continued operation during power
mains interruptions, it is recommended that the T-Stat®
2.0 be powered from an uninterruptible power
supply or a 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.