Electromagnetic emissions and immunity, Emc guidance – Philips Smart ear thermometer SCH740/86 User Manual
Page 7
Indicates the manufacturer's serial
number 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
cautionary information such as warnings
and precautions that cannot, for a variety
of reasons, be presented on the medical
device itself.
IP22: The first number 2: Protected against
solid foreign objects of 12,5 mm
Ф and
greater. The second number: Protected
against vertically falling water drops when
enclosure is tilted up to 15°. Vertically
falling drops shall have no harmful effects
when the enclosure is tilted at any angle
up to 15° on either side of the vertical.
–20ºC
60ºC
Indicates the storage and transportation
temperature limits to which the medical
device can be safely exposed: -20°C to
60°C.
Indicates the storage and transportation
relative humidity limits to which the
medical device can be safely exposed:
15% - 85%
Symbol for the 2 year Philips guarantee.
The Green Dot ('Der Grüne Punkt' in
German) is the license symbol of a
European network of industry-funded
systems for recycling the packaging
materials of consumer 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
information provided in this document.
- Wireless communications equipment such as
wireless home network devices, mobile phones,
cordless telephones and their base stations,
walkie-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
immunity level of 3V/m.
Guidance and manufacturer's declaration
– electromagnetic emissions - for all ME
equipment and ME systems
Guidance and manufacturer’s declaration –
electromagnetic emissions
The device is intended for use in the
electromagnetic environment specified below. The
customer or the user of the device should assure
that it is used in such an environment.
Emissions
test
Compli
ance
Electromagnetic
environment -
guidance
RF emissions
CISPR 11
Group 1
The SCH740 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 emissions
CISPR 11
Class B
Harmonic
emissions IEC
61000-3-2
Not
applica
ble
Voltage
fluctua
tions/flicker
emissions IEC
61000-3-3
Not
applica
ble
Guidance and manufacturer's declaration
– electromagnetic immunity – for all ME
equipment and ME systems
Guidance and manufacturer’s declaration –
electromagnetic immunity
The device is intended for use in the
electromagnetic environment specified below. The
customer or the user of the device should assure
that it is used in such an environment.
Immu
nity
test
IEC
60601
test
level
Com
pli
ance
level
Electromagnetic
environment -
guidance
Electro
static
dis
charge
(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%.
Power
fre
quency
(50/60
Hz)
magnet
ic 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
commercial or
hospital
environment.