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14
Guidance and manufacturer’s declaration – electromagnetic immunity
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 ANAYLSIS
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.
Guidance and manufacturer’s declaration – electromagnetic emissions
The VNT275 equipment is intended for use in the electromagnetic environment specified
below. The customer or the user of the VNT275 should ensure that it is used in such an
environment.
Emissions Test Compliance Electromagnetic environment – guidance
RF Emissions
CISPR 11
Group 1 The ME equipment uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF Emissions
CISPR 11
Class B
Complies
Harmonic emissions
IEC 61000-3-2
Not
Applicable
The ME equipment is
solely battery powered
Voltage fluctuations/
flicker emissions
Not
Applicable
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