Use Instructions

Instructions For Use | 4544 | © 2018 Endotronix Inc.
100474-00 Rev 1
Appendices
Appendix A: Electromagnetic Compatibility
Guidance and Manufacturer’s Declaration – Electromagnetic
Emissions & Immunity
These 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:
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
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, ±4V, ±8kV,
+15kV air
±8kV contact
±2kV, ±4V, ±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%.
Electrical Fast
Transient/Burst
Immunity
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/output
lines
±2 kV for power
supply lines
±1 kV for input/
output lines
Mains power quality
should be that of a typical
professional healthcare
facility or home healthcare
environments.
Surge
IEC 61000-4-5
±1 kV line to line ±1 kV line to line
±0.5 kV line to line ±0.5 kV line to line
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
0% UT (100% dip in
UT) for 0.5 cycle
0% UT (100% dip
in UT) for 0.5 cycle
0% UT (100% dip in
UT) for 1 cycle
0% UT (100% dip
in UT) for 1 cycle
70% UT (30%
dip in UT) for 25
cycles(50Hz) and 30
cycles(60Hz)
70% UT (30%
dip in UT) for 25
cycles(50Hz) and
30 cycles(60Hz)
0% UT (100%
interruption in UT) for
250 cycles(50Hz) and
300 cycles(60Hz)
0% UT (100%
interruption
in UT) for 250
cycles(50Hz) and
300 cycles(60Hz)
Power
Frequency
Magnetic Field
IEC 61000-4-8
30A/m
50Hz and 60Hz
30A/m
50Hz and 60Hz
Power frequency magnetic
fields should be at levels
characteristic of a typical
professional healthcare
facility or home healthcare
environments.