Table of Contents
Advertisement
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
Electrostatic Discharge (ESD)
IEC (EN) 61000-4-2
Electrical Fast Transients
(bursts)
IEC (EN) 61000-4-4
Mains surge
IEC (EN) 61000-4-5
Voltage Drops
IEC (EN) 61000-4-11
Magnetic Field at Industrial
Frequency
IEC (EN) 61000-4-8
Radiated Radiofrequency
IEC (EN) 61000-4-3
Conducted Radiofrequency
IEC (EN) 61000-4-6
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.
TEST LEVEL
COMPLIANCE
IEC 60601
±8kV
Contact
±15kV
Air
±2kV for power lines
±2kV for power lines
±1kV between
±1kV between
phases
±2kV between
±2kV between
phases and earth
phases and earth
±1kV for input/
±1kV for input/
output/earth lines
output/earth lines
0% UT (100% drop
0% UT (100% drop
in UT); 0.5 cycles
in UT); 0.5 cycles
40% UT (60% drop
40% UT (60% drop
in UT); 10 cycles
in UT); 10 cycles
0% UT (100% drop
0% UT (100% drop
in UT); 5s
30 A/m
10 V/m
80MHz - 6GHz
80MHz - 6GHz
10V
150kHz - 100MHz
150kHz - 100MHz
ELECTROMAGNETIC ENVIRONMENT
Floors must be made from wood,
±8kV
concrete or ceramic tiles.
Contact
If the floors are covered in synthetic
±15kV
material, the relative humidity must be at
Air
least 30%.
The quality of the electrical supply
network must be equivalent to that of a
commercial or hospital setting.
phases
The quality of the electrical supply
network must be equivalent to that of a
commercial or hospital setting.
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.
in UT); 5s
Magnetic fields at industrial frequency
30 A/m
must be those of a typical hospital or
commercial setting.
The distance between portable or
10 V/m
mobile radiofrequency communication
equipment and the device, including
cables, must not be less than the
recommended
which is calculated using the applicable
equation for the transmitter frequency.
Recommended separation distance:
d = 1,2√ P ; < 80MHz
10V
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).
ENG
separation
distance,
23
Advertisement
Table of Contents
