13
ELECTROMAGNETIC COMPATIBILITY
(
EMC
)
EN
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Immunity
Test
IEC
60601
Test Level
Compliance
Level
Electromagnetic
Environment
Guidance
Electrostatic
Discharge
(ESD)
IEC
61000-4-2
±
6
kV contact
±
8
kV air
±8 kV
contact
±
15
kV 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
IEC
61000-4-4
±
2
kV for power
supply lines
±
1
kV for input/
output lines
N/A. Battery
Powered.
Mains power qual-
ity should be that
of a typical com-
mercial or hospital
environment.
Surge
IEC
61000-4-5
±
1
kV di
ff
erential
mode
±
2
kV common
mode
N/A. Battery
Powered.
Mains power qual-
ity should be that
of a typical com-
mercial or hospital
environment.
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC
61000-4-11
<
5
% U (>
95
% dip in
TU ) for
0
.
5
cycle
40
% U
(60
% dip in
TU ) for
5
cycles
70
% U (
30
% dip in
TU ) for
25
cycles
<
5
% U (>
95
% dip in
TU) for
5
sec
N/A. Battery
Powered.
Mains power qual-
ity should be that
of a typical com-
mercial or hospital
environment.
Power
Frequency
(
50
/
60
Hz)
Magnetic
Fields
IEC
61000-4-8
3
A/m
30
A/m
Power frequency
magnetic fields
should be at levels
characteristic of
a typical location
in a typical com-
mercial or hospital
environment.
Summary of Contents for X4
Page 1: ...X4TM Knee Brace Instructions for Use ...
Page 2: ......
