User's Manual

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Guidance and manufacturer´s declaration – electromagnetic immunity
The Model smartho-D2 are intended for use in the electromagnetic environment specified below. The customer or the user
of the Model smartho-D2 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
± 8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
± 8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 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 %.
Electrostatic
transient / burst
IEC 61000-4-4
± 2 kV for power
supply lines
100 kHz repetition
frequency
± 1 kV for input/output
lines
N/A
N/A
Surge
IEC 61000-4-5
± 0.5 kV, ± 1 kV
differential
mode
line-line
N/A
N/A
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
0 % UT
(100 % dip in UT )
for 0.5 cycle at 0°, 45°,
90°, 135°,180°, 225°,
270°, and 315°
0 % UT
(100 % dip in UT )
for 1 cycle at 0°
70 % UT
(30 % dip in UT )
for 25/30 cycles at 0°
0 % UT
(100 % dip in UT )
for 250/300 cycle at 0°
N/A
N/A
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m, 50/60Hz
30 A/m, 50/60Hz
Power frequency magnetic fields should be at
levels characteristic of a typical location in a typical
commercial or hospital environment.
NOTE: UT is the a. c. mains voltage prior to application of the test level.
510(K) Response to Deficiency on K191667-S001
006_User Manual
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