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ANNEX
EMC Guidance
The BXα-13 or BXα-13A is a medical device and requires special precautions regarding EMC.
Refer to the following EMC information for appropriate installation and putting into service.
Take care when using portable and mobile RF communications equipment in proximity of the
BXα-13 or BXα-13A, as they can affect performance.
(1) Environments of intended use:
Professional healthcare facility environments and home healthcare environments
(2) Replaceable cables, transducers or accessories likely to affect compliance of the BXα-13 or
BXα-13A with the applied EMC Standard:
N/A
(3) Applied EMC Standard:
IEC 60601-1-2:2014
(a) Connection to the public mains network: None
(b) Applicable port(s): Enclosure Port
Electromagnetic Emissions
Phenomenon Applied Standard Emission Test Levels
Conducted and radiated RF
emissions
CISPR 11 Class B Group 1
Phenomenon Applied Standard Immunity Test Levels
Electrostatic discharge IEC 61000-4-2 ± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radiated RF EM fields /
Proximity fields from RF
wireless communications
equipment
IEC 61000-4-3 10 V/m
80 MHz – 2.7 GHz
80 % AM at 1 kHz
385 MHz – 5785 MHz
Rated power frequency
magnetic fields
IEC 61000-4-8 30 A/m
50 Hz or 60 Hz
(4) Effect of electromagnetic disturbances on essential performance
Essential Performance Outcome if Essential Performance is Lost or Degraded
Continuous steady illumination Flickering illumination
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