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Guidance and manufacturer's declaration – electromagnetic immunity
The BNT400CA is intended for use in the electromagnetic environment specified below.
The customer or the user of the BNT400CA should ensure that it is used in such an environment.
Phenomenon
Electrostatic discharge
Radiated RF
Proximity fields from RF wireless
communications equipment
RATED power frequency
magnetic fields d) e)
A. The interface between the PATIENT physiological signal simulation, if used, and the ME EQUIPMENT or ME SYSTEM shall
be located within 0,1 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 or 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 beadjusted as appropriate for
the minimum expected distance.
Guidance and manufacturer's declaration – electromagnetic emissions
The BNT400CA equipment is intended for use in the electromagnetic environment specified below. The customer or the user
of the BNT400CA should ensure that it is used in such an environment.
Emissions Test
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic emissions IEC
61000-3-2
Voltage fluctuations/
flicker emissions
Basic EMC
standard or test
method
IEC 61000-4-2
IEC 61000-4-3
IEC 61000-4-3
IEC 61000-4-8
Compliance
The ME equipment uses RF energy only for its internal function. Therefore,
Group 1
its RF emissions are very low and are not likely to cause any interference in
Class B
Not Applicable
Not Applicable
Immunity Test Levels
Home Healthcare Enviroment
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
10 V/m f )
80 MHz – 2,7 GHz b)
80 % AM at 1 kHz c)
See RF wireless communication equipment immunity table
below
30 A/m g)
50 Hz or 60 Hz
Electromagnetic environment – guidance
nearby electronic equipment.
Complies
The ME equipment is
solely battery powered.
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