59
59
EN
Appendix A: Informations reg. EMF according to EN 60601-1-2
The
b-intense
®
MED are intended for use in the electromagnetic environment specified below. The user of the above listed models should
assure that they are used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The b-intense MED use 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
b-intense
®
MED are intended for use in the electromagnetic environment specified below. The user of the
b-intense
®
MED should
assure that they are used in such an environment.
Enclosure Port
Immunity test
Test Condition
IEC 60601
Compliance level
Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±,8 kV Contact
± 2,4,8,15 kV Air
±,8 kV Contact
± 2,4,8,15 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%.
Radiated RF EM
fields and Proximi-
ty fields from RF
wireless communi-
cations equipment
IEC 61000-4-3
3 V/m
80 MHz – 2,7 GHz
80 % AM 1 kHz
3 V/m
80 MHz – 2,7 GHz
Mains power quality should be that of a profes-
sional healthcare facility environment.
385 MHz (18Hz Pulse Modulation)
27 V/m
450 MHz (FM+/-5KHz deviation 1kHz
sine or 18Hz Pulse Modulation)
28 V/m
710 MHz (217Hz PM)
9 V/m
745 MHz (217Hz PM)
9 V/m
780 MHz (217Hz PM)
9 V/m
810 MHz (18Hz PM)
28 V/m
870 MHz (18Hz PM)
28 V/m
930 MHz (18Hz PM)
28 V/m
1720 MHz (217Hz PM)
28 V/m
1845 MHz (217Hz PM)
28 V/m
1970 MHz (217Hz PM)
28 V/m
2450 MHz (217Hz PM)
28 V/m
5240 MHz (217Hz PM)
9 V/m
5500 MHz (217Hz PM)
9 V/m
5785 MHz (217Hz PM)
9 V/m
RATED power
frequency
magnetic fields
IEC 61000-4-8
50 Hz or 60 Hz
30 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Comment: --
The
b-intense
®
MED are intended for use in the electromagnetic environment specified below. The user of the
b-intense
®
MED should
assure that they are used in such an environment.
Input a.c. power Port
Immunity test
Test Condition
IEC 60601
Compliance level
Electromagnetic environment - guidance
Electrical fast
transient/bursts
IEC 610004-4
± 2 kV
100kHz Repetition frequency
± 2 kV
Mains power quality should be that of a professi-
onal healthcare facility environment.
Surges
IEC 61000-4-5
± 0,5kV, ±1 kV line(s) to line(s)
± 0,5kV, ±1 kV, ± 2 kV line(s) to ground
(a)
± 1 kV Differential mode
± 2 kV Common mode
Mains power quality should be that of a professi-
onal healthcare facility environment.
Conducted RF
induced by RF
fields
IEC 61000-4-6
3 Vrms
150 kHz - 80 MHz
6 Vrms ISM Bands c)
80% AM 1kHz
3 Vrms
150 kHz - 80 MHz
6 Vrms ISM Bands c)
80 % AM 1 kHz
Mains power quality should be that of a professi-
onal healthcare facility environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
0 % UT;
0°,45°,90°,135°,180°,225°,270°,31
5°
0 % UT;
0°
0 % UT;
70 %
0 % UT;
0 %
0,5 Cycles
1Cycle
25/30 Cycles (50/60 Hz)
250/300 Cycles
(50/60 Hz) (5s)
Mains power quality should be that of a professi-
onal healthcare facility environment.
If the user of
b-intense
®
MED requires continu-
ed operation during power mains interruptions, it
is recommended that the
b-intense
®
MED are
powered from an uninterruptible power supply or
battery.
Comment:
a) Not applicable to CLASS II ME EQUIPMENT and ME SYSTEMS.
b) 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.
