48
KOHJ-H-15-EN1-1.0-15102021
Appendices
Appendix 1: Carital Controllers - Guidance and Manufacturer’s Declarations – EMC
Electromagnetic Emissions (IEC 60601-1-2)
Emission Test
Compliance
Electromagnetic environment -
guidance
RF Emissions CISPR
11
Group 1, Class B
Carital mattress systems are suitable
for use in all establishments including
domestic establishments
Harmonic
Emissions: IEC
61000-3-2
Complies
Voltage fluctu
-
ations/flicker
emissions: IEC
61000-3-3
Complies
Electromagnetic Immunity (IEC 60601-1-2)
Emission Test
IEC 60601 test level
Compliance level
Electromagnetic environment -
guidance
Electrostatic dis-
charge (ESD) IEC
61000-4-2
±8kV contact, ±2kV,
±4kV, ±8kV, ±15kV air
±8kV contact, ±2kV,
±4kV, ±8kV, ±15kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst IEC
61000-4-4
±2kV for power supply
lines, ±1kV for input/
output lines
±2kV for power supply
lines, ±1kV for input/
output lines
Mains supply quality for the mains
adapter should be that of a typical
commercial and/or hospital environ-
ment.
Surge 61000-4-5
±0.5 kV, ±1 kV, ±2 kV
Line-to-ground
±0.5 kV, ±1 kV, ±2 kV
Line-to-ground
Mains supply quality for the mains
adapter should be that of a typical
commercial and/or hospital environ-
ment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines IEC
61000-4-11
0% UT; 0.5 cycle at 0°,
45°, 90°, 135°, 180°,
225°, 270° and 315°
0% UT; 1 cycle 70% UT;
25/30 cycles Single
phase: at 0°
0% UT; 250/300 cycle
0% UT; 0.5 cycle at 0°,
45°, 90°, 135°, 180°,
225°, 270° and 315°
0% UT; 1 cycle 70% UT;
25/30 cycles Single
phase: at 0°
0 % UT; 250/300 cycle
Mains power quality should be that
of a typical commercial and/or hos-
pital environment. If the user of the
Carital mattress system requires con-
tinued operation during power mains
interruption, it is recommended that
the Carital controller is powered from
an uninterruptible power supply or
battery.
Power frequen-
cy (50/60 Hz)
magnetic field IEC
61000-4-8
30A/m
30A/m
Mains frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commer-
cial and/or hospital environment.
Note: Ur is the A.C. mains voltage prior to application of the test level.
Conducted RF IEC
61000-4-6
3 Vrms (150 kHz to 80
MHz), 6 Vrms in ISM
bands between 150
kHz to 80 MHz (80 %
AM at 1 kHz)
Portable and mobile RF communica-
tions equipment should not be used
closer than 30cm (12 inch) of Carital
controller, including cables. Using
portable and mobile RF communica-
tions equipment too close may result
Carital controller in not functioning
properly.
Interference may occur in the vicinity
of equipment marked with the follow-
ing symbol
Radiated RF IEC
61000-4-3
10V/m (80 MHz to 2,7
GHz) and 20 V/m (800
MHz to 2,5 GHz)
10V/m (80 MHz to 2,7
GHz) and 20 V/m (800
MHz to 2,5 GHz)
Proximity fields
from RF wireless
communications
EQUIPMENT IEC
61000-4-3
9V/m 710MHz, 745MHz,
780MHz, 5,240MHz,
5,500MHz and 5,785MHz
27V/m 385MHz
28V/m 450MHz,
810MHz, 870MHz,
930MHz, 1,720MHz,
1,845MHz, 1,970MHz
and 2,450MHz
9V/m 710MHz, 745MHz,
780MHz, 5,240MHz,
5,500MHz and 5,785MHz
27V/m 385MHz
28 V/m 450 MHz,
810 MHz, 870 MHz, 930
MHz, 1720 MHz, 1845
MHz, 1970 MHz and
2450 MHz
