Guidance and manufacture’s declaration
The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment specified below. The customer
or the user of [EQUIPMENT or SYSTEM] should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level
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
floor are covered with
synthetic material, the
relative humidity should be
at least 30%. If ESD
interfere with the operation
of equipment ,counter
measurements such as
wrist strap, grounding shall
be considered.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply
lines
±1 kV for
lines
Not applicable
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
Not applicable 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 sec
Not applicable Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
the TL-100Drequires
continued operation during
power mains interruptions, it
is recommended that the
TL-100Dbe powered from an
uninterruptible power supply
or a battery.
Power frequency
(50Hz) magnetic
field IEC 61000-4-8
3A/m 3A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE U
is the a.c. mains voltage prior to application of the test level.