1
Electromagnetic Compatibility Information
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
Table 2
Guidance and declaration of manufacturer-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 environmentguidance
Compliance
level
IEC 60601
test level
IMMUNITY test
N/A
10 V/m
3 Vrms 150
kHz to 80
Mhz
10 V/m 80
MHz to 2.7
Ghz
Conducted
RF IEC
61000-4-6
Radiated RF
IEC 61000-
4-3
Table 3
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 seperation distance
80 MHz to 800 MHz
800 MHz to 2.7 Ghz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transm-
itter 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.
Interference may occur in the vicinity of equipment
marked with the following symbol:
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 therefore
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.
Rated maximum output power
of transmitter
W
Table 4
800 MHz to
GHz
2.7
0.01
0.1
1
10
100
0.12
0.38
1.2
3.8
0.23
0.73
2.3
7.3
23
Guidance and declaration of manufacturer-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.
Electromagnetic environment-guidance
Compliance
Emissions test
The device uses RF energy only for its internal function.
Therefore, its emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Group 1
RF emissions CISPR 11
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.
Class B
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
N/A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
N/A
12
Separation distance according to frequency of transmitter
m
80 MHz to 800 MHz
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.
NOTE1 At 80 MHz and 800 MHz, the separation distance for the higer frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Guidance and declaration of manufacturer-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 environm
entguidance
Compliance
level
124mm
2
5
4
m
m
IEC 60601 test level
IMMUNITY test
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
contact
±
2 kV,
±
4 kV,
±
8 kV,
±
15 kV air
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrostatic
transient/burst
IEC 61000-4-4
±
2 kV for
power supply
lines
±
1 kV for
input/output
lines
N/A
Surge
IEC 61000-4-5
±
1 kV
differential
mode
±
2 kV
common
mode
N/A
Voltage dips,
short interrupti-
ons and voltage
variations on p-
ower supply in-
put lines
IEC 61000-4-11
< 5% UT (>95% dip in UT)
for 0.5 cycle
40% UT (60% dip in UT)
for 5 cycle
70% UT (30% dip in UT)
for 25 cycle
<5% UT (>95% dip in UT)
for 5 secretary
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Power frequency magnetic fields
should be at levels charactertic of a
typical location in a typical comme-
rcial or hospital environment.
N/A
±
8 kV
contact
±
2 kV,
±
4 kV,
±
8 kV,
±
15 kV air
30 A/m; 50Hz
or 60Hz
30 A/m; 50Hz
or 60Hz
380MHz, 27V
/m
450MHz, 28V
/m
710MHz,745
MHZ,780MHz
9V/m
810MHz,870
MHZ,930MHz
28V/m
1720MHz,1845
MHZ,1970MHz
28V/m
2450MHz, 28V
/m
5240MHz,5500
MHZ,5785MHz
9V/m
380MHz, 27V
/m
450MHz, 28V
/m
710MHz,745
MHZ,780MHz
9V/m
810MHz,870
MHZ,930MHz
28V/m
1720MHz,1845
MHZ,1970MHz
28V/m
2450MHz, 28V
/m
5240MHz,5500
MHZ,5785MHz
9V/m
RF Wireless
Communication
Equipment
IEC 61000-
4-3