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13.
EMC (Electromagnetic Compatibility) Decalaration
This equipment generates, uses and can radiate radio frequency (RF) energy. This equipment
may cause electromagnetic interference if it is not installed and used in accordance with the
manual.
This device has been tested for Medical Products in accordance with EN-60601-1-2 and has
been determined to comply with acceptable limits. These limits indicate that the device
provides an acceptable level of protection against electromagnetic interference (EMC) if the
device is used as specified in the manual.
This device may be affected by portable and mobile RF communication devices. This
equipment must not be stored together with other equipment.
See the following tables for more information about this device and EMC.
Guidance and Manufactures Declaration-Electromagnetic
These devices are intended for use in the electromagnetic environment specified below. The customer or the user of
the device should assure that the device is used in such an environment.
Emissions Test Compliance
Electromagnetic environment
—
guidance
RF emissions
CISPR 11
Group 1
The device 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
The device is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage network
that supplies buildings used for domestic purposes.
Harmonic
Emissions
Class A
IEC 61000-3-2
Voltage
Fluctuations/Flick
er Emissions IEC
61000-3-3
Complies
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Guidance and Manufactures Declaration-Electromagnetic
These devices are intended for use in the electromagnetic environment specified below. The customer or the user of
the device should assure that the device is used in such an environment.
Immunity Test
IEC60601 Test
Level
Compliance
Level
Electromagnetic environment
—
guidance
Electrostatic
discharge
(ESD) IEC 61000-
4-2
± 6 kV contact
± 6 kV contact
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should be
at least 30%.
± 8 kV air
± 8 kV air
Electrical fast
transient/
burst IEC 61000-4-
4
±2 kV for power
supply lines
±1 kV for
input/output lines
± 6 kV for power
supply lines
± 1 kV for
input/output lines
Mains power quality should be that of a typical commercial or
hospital environment.
Surge
±1 kV differential
Mode
±2 kV common
mode
±1 kV differential
mode
±2 kV common
mode
Mains power quality should be that of a typical commercial or
hospital environment.
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
<%5
U
T
(
U
T
’de >%95
düşüş) 0,5 devir
için
%40
U
T
(
U
T
’de %60 düşüş)
5 devir için
%70
U
T
(
U
T
’de %30 düşüş)
25 devir için
<%5
U
T
(
U
T
’de >%95
düşüş) 5 saniye
için
Mains power quality should be that of a typical commercial or
hospital
environment.
If the user of the device requires continued operation during
power
mains interruptions, it is recommended that the device be
powered from
an uninterruptible power source
Power frequency
(50/60Hz)
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:
Ut is the AC mains voltage prior to application of the test level.
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Guidance and Manufactures Declaration-Electromagnetic
These devices are intended for use in the electromagnetic environment specified below. The customer or the user
of the device should assure that the device is used in such an environment.
Immunity Test
IEC60601 Test
Level
Compliance
Level
Electromagnetic environment
—
guidance
Conducted RF
IEC 61000-4-6
3 V rms
3 V
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
150 kHz ila 80 MHz
Radiated RF
IEC 61000-4-3
10 V rms
10 V
150 kHz ila 80 MHz
10 V/m
80 MHz ila 2,5 GHz
10 V/m
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 meters (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.
Not 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 environmentdue 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 abnormalperformance is observed, additional measures may be
necessary, such as reorienting or relocating the device.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m
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Recommended separation distance between portable and mobile RF communication equipment and this device
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Rated maximum
output power
of transmitter (W)
Separation distance according to frequency of
transmitter (m)
150 kHz ila
150 kHz ila
80 MHz ila
80 MHz ila
80 MHz, Outside ISM
Bands
80 MHz,In ISM
Bands
800 MHz
800 MHz
0,01
0,12
0,12
0,12
0,23
0,1
0,37
0,38
0,38
0,73
1
1,16
1,20
1,20
2,30
10
3,67
3,79
3,79
7,27
100
11,60
12,00
12,00
23,00
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres
(m) can be determined 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 80 MHz and 800 MHz, the separation distance for the higher frequency range applies..
Note 2
. ISM (industrial, scientific, and medical) bands from 150 kHz to 80 MHz are 6,765 MHz to 6,795 MHz;
13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz and 40,66 MHz to 40,70 MHz.
Note 3
. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
