ENG
23
MANUFACTURER DIRECTIVES AND DECLARATION – ELECTROMAGNETIC IMMUNITIES
Our devices are designed to be used in an ELECTROMAGNETIC ENVIRONMENT as specified below. The user must
ensure that the units can operate in that environment.
NOTE:
Home health care settings have higher immunity requirements than professional medical care facilities. Therefore,
the interference immunity requirements for professional medical care centers are included here.
STANDARD BASIC EMC
IMMUNITIES TEST
TEST LEVEL
IEC 60601
COMPLIANCE
ELECTROMAGNETIC ENVIRONMENT
Electrostatic Discharge (ESD)
IEC (EN) 61000-4-2
±8kV
Contact
±15kV
Air
±8kV
Contact
±15kV
Air
Floors must be made from wood,
concrete or ceramic tiles.
If the floors are covered in synthetic
material, the relative humidity must be at
least 30%.
Electrical Fast Transients
(bursts)
IEC (EN) 61000-4-4
±2kV for power lines
±1kV between
phases
±2kV for power lines
±1kV between
phases
The quality of the electrical supply
network must be equivalent to that of a
commercial or hospital setting.
Mains surge
IEC (EN) 61000-4-5
±2kV between
phases and earth
±1kV for input/
output/earth lines
±2kV between
phases and earth
±1kV for input/
output/earth lines
The quality of the electrical supply
network must be equivalent to that of a
commercial or hospital setting.
Voltage Drops
IEC (EN) 61000-4-11
0% UT (100% drop
in UT); 0.5 cycles
40% UT (60% drop
in UT); 10 cycles
0% UT (100% drop
in UT); 5s
0% UT (100% drop
in UT); 0.5 cycles
40% UT (60% drop
in UT); 10 cycles
0% UT (100% drop
in UT); 5s
The quality of the electrical supply
network must be equivalent to that
of a commercial or hospital setting.
If the device user requires continued
use during power cuts, we recommend
powering the device with a different
power source or battery.
Magnetic Field at Industrial
Frequency
IEC (EN) 61000-4-8
30 A/m
30 A/m
Magnetic fields at industrial frequency
must be those of a typical hospital or
commercial setting.
Radiated Radiofrequency
IEC (EN) 61000-4-3
10 V/m
80MHz - 6GHz
10 V/m
80MHz - 6GHz
The distance between portable or
mobile radiofrequency communication
equipment and the device, including
cables, must not be less than the
recommended separation distance,
which is calculated using the applicable
equation for the transmitter frequency.
Recommended separation distance:
d
= 1,2√
P
; < 80MHz
d
= 1,2√
P
; de 80MHz - 800MHz
d
= 2,3√
P
; de 800MHz - 2,7GHz
P
is the maximum rated power output
of the transmitter in watts (W) and
d
is
the recommended separation distance in
meters (m).
Conducted Radiofrequency
IEC (EN) 61000-4-6
10V
150kHz - 100MHz
10V
150kHz - 100MHz
NOTE 1:
UT is the AC network voltage before applying the test level.
NOTE 2:
The upper frequency range is applied at 80MHz and 800MHz.
NOTE 3:
These directives may not be applicable in all situations. Electromagnetic propagation is affected by the absorption
and reflection of structures, objects and people.
