The device satisfies the EMC requirements of the international standard IEC 60601-1-2. The requirements
are satisfied under the conditions described in the table below. The device is an electrical medical product
and is subject to special precautionary measures with regard to EMC which must be published in the
instructions for use. Portable and mobile HF communications equipment can affect the device. Use of
the unit in conjunction with non-approved accessories can affect the device negatively and alter the
electromagnetic compatibility. The device should not be used directly adjacent to or between other
electrical equipment.
Table 1
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Not applicable
Emissions test
Compliance
Electromagnetic environment — guidance
RF emissions
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 power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable
Guidance and manufacturer's declaration — electromagnetic emission
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.
Table 2
NOTE: UT is the a. c. mains voltage prior to application of the test level.
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.
Electromagnetic environment -
guidance
Immunity test
IEC 60601
test level
Compliance
level
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV
air
± 8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 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 %.
Electrostatic
transient / burst
IEC 61000-4-4
± 2 kV for power supply lines
100 kHz repetition frequency
± 1 kV for input/output lines
N/A
N/A
N/A
N/A
N/A
N/A
Surge
IEC 61000-4-5
± 0.5 kV, ± 1 kV
differential mode
line-line
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
0 % UT
(100 % dip in UT )
for 0.5 cycle at 0°, 45°,
90°, 135°,180°, 225°,
270°, and 315°
0 % UT
(100 % dip in UT)
for 1 cycle at 0°
70 % UT
(30 % dip in UT )
for 25/30 cycles at 0°
0 % UT
(100 % dip in UT)
for 250/300 cycle at 0°
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 Aim,
50/60Hz
30 A/m,
50/60Hz
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
Table 3
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.
Electromagnetic environment -
guidance
Immunity test
IEC 60601
test level
Compliance
level
Table 4
Recommended separation distances between
portable and mobile RF communications equipment and the device
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
6 Vrms 150 kHz to
80 MHz outside
ISM bandsa
10 V/m
80 MHz to 2.7 GHz
N/A
10 V/m
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
80MHz to 800MHz
800MHz to 2.7GHz
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:
Table 5
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. The ISM (industrial, scientific and medical) bands between 0,15 MHz and 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.
The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz,
5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,
17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
b. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range
80 MHz to 2,7 GHz are intended to decrease the likelihood that mobile/portable communications equipment
could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of
10/3 has been incorporated into the formulae used in calculating the recommended separation distance for
transmitters in these frequency ranges.
c. 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.
d. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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.
NOTE 1 At 80 MHz and 800 MHz, 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.
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.
Rated maximum
output of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.7 GHz
0.01
0.12
0.04
0.07
0.1
0.37
0.12
0.23
1
1.17
0.35
0.7
10
3.7
1.11
2.22
100
11.7
3.5
385
1.8
0.3
450
2
0.3
710
0.2
0.3
0.3
0.3
0.3
0.3
27
28
9
28
28
28
9
27
28
9
28
28
28
9
745
2
780
2
810
2
870
0.2
930
1720
1845
1970
2450
5240
5500
5785
7.0
Recommended separation distances between RF wireless communications equipment
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 RF wireless communications equipment and the device as
recommended below, according to the maximum output power of the communications equipment.
WARNINGS!
• This device should not be used in the vicinity or on the top of other electronic equipment such as cell phone,
transceiver or radio control products. If you have to do so, the device should be observed to verify normal operation.
• The use of accessories and power cord other than those specified, with the exception of cables sold by the
manufacturer of the equipment or system as replacement parts for internal components, may result in increased
emissions or decreased immunity of the equipment or system.
Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
Frequency
MHz
Electromagnetic
Environment - Guidance
Maximum
Power
W
Distance
IEC 60601
Test Level
Compliance
Level
RF wireless 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
Where P is the maximum output
power rating of the ransmitter in
watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m). Field
strengths from fixed RF
transmitter, as determined by an
electromagnetic site survey,
should be less than the
compliance level in each
frequency range. Interference
may occur in the vicinity of
equipment marked with the
following symbol:
