User Manual

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© 2019 Endotronix® Inc. 100469-00 Rev. 2
Appendix C: Electromagnetic Guidance
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
& Immunity
The myCordella™ Patient Reader and Docking Station are
investigational devices that comply with IEC 60601-1-2 Ed. 4.0. The
Reader and Docking Station are Class II ME Equipment and the Reader
is a BF Applied Part.
The Reader and Docking Station are intended for use in the
electromagnetic environment specified below.
The operator of the Reader and Docking Station should assure that it
is used in such an environment.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The myCordella™ Patient Reader and Docking Station are
investigational devices that comply with IEC 60601-1-2 Ed. 4.0.
The Reader and Docking Station are intended for use in the
electromagnetic environment specified below.
Immunity Test
Test Level
Compliance
Electromagnetic Environment -
Guidance
Electrostatic
Discharge Immunity
IEC 61000-4-2
±8kV contact
±2kV, ±4kV, ±8kV,
±15kV air
±8kV contact
±2kV, ±4kV, ±8kV,
±15kV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Emissions Test
Compliance
Electromagnetic Environment -
Guidance
Conducted Emissions
CISPR 11
Class B, Group 1
The Reader must emit
electromagnetic energy in order to
perform its intended function.
Nearby electronic equipment may be
affected. The Reader is suitable for
use in
professional healthcare facility and
home healthcare environments.
Radiated Emissions
CISPR 11
Class B, Group 1
Harmonic Current Emissions
IEC 61000-3-2
Class A
Voltage changes, Fluctuations/Flicker
Emissions
IEC 61000-3-3
Compliant