Manufacturer’s declaration-electromagnetic immunity
The Kinsa Smart Ear Thermometer is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the Kinsa Smart Ear Thermometer should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic
environment-guidance
(for home healthcare environment)
Electrostatic
discharge(ESD)
IEC 61000-4-2
Contact:
±
8 kV
Air
±
2 kV,
±
4 kV,
±
8 kV,
±
15 kV
Contact:
±
8 kV
Air
±
2 kV,
±
4 kV,
±
8 kV,
±
15 kV
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
+ 2kV for power supply lines
+ 1kV for input/output lines
Not applicable
Not applicable
Mains power quality should be that of a
typical home healthcare environment.
Surge
IEC 61000-4-5
+ 0.5kV, +1kV line(s) to line(s)
+ 0.5kV, +1kV,+ 2kV line(s) to
earth
Not applicable
Not applicable
Mains power quality should be that of a
typical home healthcare environment.
Voltage Dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
Voltage dips:
0 %
U
T
; 0,5 cycle
0 %
U
T
; 1 cycle
70 %
U
T
; 25/30 cycles
Voltage interruptions:
0 %
U
T
; 250/300 cycle
Voltage dips:
Not applicable
Not applicable
Not applicable
Voltage interruptions:
Not applicable
Mains power quality should be that of a
typical home healthcare environment.
If the user of the Kinsa Smart Ear
Thermometer requires continued
operation during power mains
interruptions, it is recommended that the
Kinsa Smart Ear Thermometer be
powered from an uninterruptible power
supply or a battery.
Power frequency(50, 60
Hz) magnetic field
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz and 60 Hz
The Kinsa Smart Ear Thermometer
power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical home healthcare
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
