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Emissions
Electromagnetic
Com pli-
test
environment -
ance
guidance
Class B
RF emissions
CISPR 11
Harmonic
Not
emissions IEC
applica-
61000-3-2
ble
Voltage
Not
fluc tu a-
applica-
tions/flick er
ble
emissions IEC
61000-3-3
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.
IEC
Com-
Electromagnetic
Immu ni-
60601
pli ance
environment -
ty test
test
level
guidance
level
±6 kV
±6 kV
Elec-
Floors should be
contact
contact
tro sta-
wood, concrete
t ic dis-
or ceramic tile. If
±8 kV air
±8 kV
charge
floors are covered
air
(ESD)
with synthetic
IEC
material, the
61000-
relative humidity
4-2
should be at least
30%.
3A/m
3A/m
Power
Power frequency
fre-
magnetic fields
quen cy
should be at levels
(50/60-
characteristic of
Hz)
a typical location
mag-
in a typical
net ic
commercial
field IEC
or hospital
61000-
environment.
4-8
Table 4 Guidance and manufacturer's
declaration – electromagnetic immunity
–for ME equipment and ME systems that
are not life supporting
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.
IMMUNITY
Compliance
-
IEC 60601
test
level
TEST LEVEL
Conducted RF
3 Vrms
3 Vrms
IEC 61000-
150 kHz to
4-6
80 MHz
Radiated RF
3 V/m
3 V/m
IEC 61000-
80 MHz to 2.5
4-3
GHz
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance:
d = 1.2
√
P
√
d = 1.2
P 80 MHz to 800MHz
√
d = 2.3
P 800 MHz to 2.5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey (a),
should be less than the compliance level in each
frequency range (b).
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher
frequency range applies.
NOTE 2 These guidelines may not apply in all
situations. Electromagnetic propagation is affected
by absorption and reflection from structures,
objects and people.
(a) Field strengths from fixed transmitters, such
as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured
field strength in the location in which the device is
used exceeds the applicable RF compliance level
above, the device should be observed to verify
normal operation. If abnormal performance is
observed, additional measures may be necessary,
such as re-orienting or relocating the device.
(b) Over the frequency range 150 kHz to 80 MHz,
field strengths should be less than 3V/m.
Table 6 Recommended separation
distances between portable and mobile
RF communications equipment and the
ME equipment or ME system – for ME
equipment and ME systems that are not
life supporting
Recommended separation distances between
portable and mobile RF communications
equipment and the device.
The device is intended for use in an
electromagnetic environment in which radiated
RF disturbances are controlled. The customer
or the user of the device can help prevent
electromagnetic interference by maintaining a
minimum distance between portable and mobile
RF communications equipment (transmitters)
and the device as recommended below,
according to the maximum output power of the
communications equipment.
Separation distance according to
frequency of transmitter (m)
Rated
150 kHz to
80 MHz
800 MHz
maximum
80 MHz
to 800
to 2.5 GHz
output
d = 1.2 √ P
MHz
d = 2.3
power of
d = 1.2 √ P
transmitter
(W)
0.12
0.12
0.23
0.01
0.1
0.37
0.74
0.37
1
1.2
1.2
2.3
10
3.7
7.4
3.7
100
12
23
12
For transmitters rated at a maximum output power
not listed above, the recommended separation
distance d in metres (m) can be estimated using
the equation applicable to the frequency of the
transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80MHz and 800MHz, the separation
distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all
situations. Electromagnetic propagation is affected
by absorption and reflection from structures,
objects and people.
Explanation of symbols
The warning signs and symbols are essential
to ensure that you use this product safely and
correctly and to protect you and others from injury.
Below you find the meaning of the warning signs
and symbols on the label and in the user manual.
Read the user manual before you use the
device.
This symbol means that the part of the
device that comes into physical contact
with the user (also known as the applied
part, probe tip) is of type BF (Body
Floating) according to IEC 60601-1.
Indicates the manufacturer.
Symbol for the 'Bluetooth Smart
mark'. The device uses Bluetooth for
communication.
Indicates the manufacturer's serial number
so that a specific medical device can be
identified.
Indicates manufacturer's catalog number
of the device.
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.
Indicates the storage and transportation
60ºC
temperature limits to which the medical
–20ºC
device can be safely exposed: -4°F to
140°F / -20°C to 60°C.
140ºF
–4ºF
Indicates the storage and transportation
relative humidity limits to which the
medical device can be safely exposed:
15% to 85%
Symbol for the 2 year Philips warranty.
This symbol is a certification mark.
It is used on electronic products
manufactured or sold in the United States.
It confirms that the electromagnetic
interference from the device is lower than
the limits approved by the FCC.
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