Mesis PressoMedical 3.0 Manuel De L'utilisateur page 49

Table 5 – Enclosure port
Phenomenon
ELECTROSTATIC
DISCHARG
Radiated RF EM
fields a)
RATED power
frequency magnetic
field d) e)
a) The interface between the PATIENT physiological signal simulation, if used, and the ME EQUIPMENT or
ME SYSTEM shall be located within 0.1m of the vertical plane of the uniform field area in one orientation
of the ME EQUIPMENT or ME SYSTEM.
b) ME EQUIPMENT and ME SYSTEM that intentionally receive RF electromagnetic energy for the purpose
of their operation shall be tested at frequency of reception. Testing may be performed at other
modulation frequencies identified by the RISK
MANAGEMENT PROCESS. This test assesses the BASIC SAFETY and ESSENTIAL PERFORMANCE
of an international receiver might not achieve normal reception during the test.
c) Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT
PROCESS.
d) Applies only to ME EQUIPMENT and ME SYSTEMS with magnetically sensitive components or circuitry.
e) During the test, the ME EQUIPMENT or ME SYSTEM may be powered at any NOMAL input voltage, but
with the same frequency as the test signal ( see Table 1).
f) ) Before modulation is applied.
g) This test level assumes a minimum distance between the ME EQUIPMENT or ME SYSTEM and sources
of power frequency magnetic field of at least 15츠. If the RISK ANALYSIS shows that the ME EQUIPMENT
or ME SYSTEM will be used closer than 15cm to sources of power frequency magnetic field, the
IMMUNITY TEST LEVEL shall be adjusted as appropriate minimum expected distance.
Basic EMC standard
or test method
IEC 61000-4-2
IEC 61000-4-3
IEC 61000-4-8
IMMUNITY TEST LEVELS
Professional healthcare facility environment
±2kV, ±4kV, ±8kV, ±15kV air
80MHz – 2.7GHz b)
80% AM at 1kHz c)
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±8kV contact
3V/m f )
30A/m g)
50Hz or 60Hz