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Symbol for 'follow instructions for use'.
This symbol means that the part of the de
vice that comes into physical contact with
the user (also known as the applied part)
is of type BF (Body Floating) according to
IEC 60601-1.
Symbol for 'the device complies with Euro
pean Medical Device Directive 93/42/EEC
requirements'. 0344 refers to the notified
body.
Symbol for WEEE, waste electrical and
electronical equipment. Electrical waste
products should not be disposed of with
household waste. Please recycle where fa
cilities exist. Check with your local authori
ty or retailer for recycling advice and see
chapter 'Battery recycling'.
This symbol means that this product
contains batteries which shall not be dis
posed of with normal household waste
(2006/66/EC).
Indicates the manufacturer, as defined in
EU Directives 93/42/EEC.
Symbol for the 'Bluetooth Combination
mark'. The device uses Bluetooth for com
munication.
Indicates the manufacturer's serial num
ber so that a specific medical device can
be identified.
Symbol for indoor use only.
Indicates caution.The user should consult
the instructions for use for important cau
tionary information such as warnings and
precautions that cannot, for a variety of
reasons, be presented on the medical de
vice itself.
This symbol on the device means: protec
ted against access to hazardous parts with
a finger and against vertically falling water
drops when tilted up to 15 degrees.
Indicates the storage and transportation
60ºC
temperature limits to which the medical
–20ºC
device can be safely exposed: -20°C to
60°C.
Symbol for the 2 year Philips guarantee.
The Green Dot ('Der Grüne Punkt' in Ger
man) is the license symbol of a European
network of industry-funded systems for re
cycling the packaging materials of consu
mer goods.
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
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emis
sions IEC
61000-3-2
Voltage fluctua
tions/flicker
emissions IEC
61000-3-3
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
IEC
ty test
60601
test le
vel
Com
Electromagnetic en
pliance
vironment - gui
dance
Group
The device must emit
2
electromagnetic ener
gy in order to perform
its intended function.
Nearby electronic
equipment may be af
fected.
Class B
Not ap
plicable
Not ap
plicable
Com
pliance
level
Electromagnetic
environment -
guidance
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