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100 User Manual(v01
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7. Statements and tables for EMC
Table 1 – Enclosure port
Phenomenon
Basic EMC
standard or test
method
IMMUNITY TEST LEVELS
Professional healthcare
facility environment
ELECTROSTATIC
DISCHARGE
IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radiated RF EM
fields a)
IEC 61000-4-3
3 V/m f)
80 MHz – 2,7 GHz b)
80 % AM at 1 kHz c)
RATED power
frequency magnetic
fields d) e)
IEC 61000-4-8
30 A/m g)
50 Hz or 60 Hz
a) The interface between the PATIENT physiological signal simulation, if used, and the ME
EQUIPMENT or ME SYSTEM shall be located within 0,1 m of the vertical plane of the uniform field
area in one orientation of the ME EQUIPMENT or ME SYSTEM.
b) ME EQUIPMENT and ME SYSTEMS that intentionally receive RF electromagnetic energy for the
purpose of their operation shall be tested at the 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 intentional receiver when an ambient
signal is in the passband. It is understood that the 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 NOMINAL 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 15 cm. If the RISK ANALYSIS shows that the
ME EQUIPMENT or ME SYSTEM will be used closer than 15 cm to sources of power frequency
magnetic field, the IMMUNITY TEST LEVEL shall be adjusted as appropriate for the minimum
expected distance.
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