Compliance and EMC Declaration
Compliance
Equipment Classification
Safety Standards: EN 60601-1: 2006+A1:2013, EN 60601-1-2:2007
Type Of Protection
Internally powered equipment (battery power)
Degree of Protection
Non-applied part
Front Panel and Case Labelling
EN ISO15223-1:2012
Temperature
EN ISO80601-2-56:2012
Home Healthcare Environment
EN 60601-1-11:2010
Guidance and Manufacturers Declaration
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Electromagnetic Emission
The Non-Contact Infrared Body Thermometer is intended for use in the electromagnetic environment specified below. The
user of the Non-Contact Infrared Body Thermometer should ensure that it is used in such an environment.
Emission Test
Compliance
Electromagnetic Environment
–
Guidance
RF emissions CISPR 11
Group 1
The Non-Contact Infrared Body Thermometer uses RF energy
only for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in
nearby electronic equipment.
RF Emission CISPR 11
Class B
The Non-Contact Infrared Body Thermometer is suitable for
use in all establishments, other than domestic and those
directly connected to the public low voltage power supply
network that supplies building used for domestic purposes.
Harmonic Emissions IEC
61000-3-2
Not Applicable
Voltage
Fluctuations/Flicker
Emissions IEC 61000-3-3
Not Applicable
Guidance and Manufacturers Declaration
–
Electromagnetic Immunity
The Non-contact Infrared Body Thermometer is intended for use in the electromagnetic environment specified below. The
user of Non-Contact Infrared Body Thermometer should ensure 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
Not applicable
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
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 Non-
Contact Infrared Body Thermometer
requires continued operation during
power mains interruptions, it is
recommended that the Non-Contact
Infrared Body Thermometer be powered
from an uninterruptible power supply or a
battery.
Power frequency
(50Hz/60Hz) 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.
