Electromagnetic emissions and
immunity
The device is approved according to EMC safety
standard EN 60601-1-2. It is designed to be used in
typical domestic environments.
EMC Guidance
- The ear thermometer needs special precautions
regarding EMC and needs to be installed and
put into service according to the EMC informa
tion provided in this document.
- Wireless communications equipment such as wi
reless home network devices, mobile phones,
cordless telephones and their base stations, wal
kie-talkies can affect this equipment and
should be kept at least a distance d = 3.3 m
away from the equipment.
Note: As indicated in IEC 60601-1-2:2007 for ME
equipment, a typical cell phone with a maximum
output power of 2 W yields d = 3.3 m at an immuni
ty level of 3V/m.
Guidance and manufacturer's declara
tion – electromagnetic emissions - for
all ME equipment and ME systems
Guidance and manufacturer’s declaration – electro
magnetic emissions
The device is intended for use in the electromagne
tic environment specified below. The customer or
the user of the device should assure that it is used
in such an environment.
Emissions test
Com
pliance
Electromagnetic en
vironment - guidan
ce
RF emissions CI
SPR 11
Group
2
The device must emit
electromagnetic ener
gy in order to perform
its intended function.
Nearby electronic
equipment may be af
fected.
RF emissions CI
SPR 11
Class B
Harmonic emis
sions IEC
61000-3-2
Not ap
plicable
Voltage fluctua
tions/flicker
emissions IEC
61000-3-3
Not ap
plicable
Guidance and manufacturer's declara
tion – electromagnetic immunity – for
all ME equipment and ME systems
Guidance and manufacturer’s declaration – electro
magnetic immunity
The device is intended for use in the electromagne
tic environment specified below. The customer or
the user of the device should assure that it is used
in such an environment.
Immuni
ty test
IEC
60601
test le
vel
Com
pliance
level
Electromagnetic
environment -
guidance
Electro
static di
scharge
(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 ma
terial, the relative
humidity should
be at least 30%.
Power
frequen
cy
(50/60H
z) ma
gnetic
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 commer
cial or hospital en
vironment.
Guidance and manufacturer's declara
tion – electromagnetic immunity –for
ME equipment and ME systems that
are not life supporting
Guidance and manufacturer’s declaration – electro
magnetic immunity
The device is intended for use in the electromagne
tic environment specified below. The customer or
the user of the device should assure that it is used
in such an environment.
IMMUNI
TY test
IEC
606
01
TE
ST
LE
VEL
Com
plia
nce
le
vel
Electromagnetic envi
ronment - guidance
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