or the user of the device should assure that it is
used in such an environment.
Immu
nity test
IEC
60601
test
level
Com
pliance
level
Electromagnetic
environment -
guidance
Electro
static
dis
charge
(ESD)
IEC
61000-
4-2
±6 kV
contact
±8 kV air
±6 kV
contact
±8 kV
air
Floors should be
wood, concrete or
ceramic tile. If
floors are covered
with synthetic
material, the rela
tive humidity
should be at least
30%.
Electri
cal fast
tran
sient/b
urst IEC
61000-
4-4
±2 kV for
power
supply
lines
±1 kV for
input/o
utput
lines
±2 kV
for
power
supply
lines
Mains power qual
ity should be that
of a typical com
mercial or hospital
environment.
Surge
IEC
61000-
4-5
±1 kV
line(s) to
line(s)
±2 kV
line(s) to
earth
±1 kV
line(s)
to
line(s)
Mains power qual
ity should be that
of a typical com
mercial or hospital
environment.
Voltage
dips,
short
interrup
tions
and
voltage
varia
tions on
power
supply
input
lines IEC
61000-
4-11
<5% UT
(>95%
dip in
UT) for
0.5
cycle
40% UT
(60%
dip in UT
) for 5
cycles
70% UT
(30% dip
in UT )
for 25
cycles
<5% UT
(>95%
dip in UT
) for 5 s
<5% UT
(>95%
dip in
UT) for
0.5
cycle
40% UT
(60%
dip in
UT ) for
5
cycles
70% UT
(30%
dip in
UT ) for
25
cycles
<5% UT
(>95%
dip in
UT ) for
5 s
Mains power qual
ity should be that
of a typical com
mercial or hospital
environment. If the
user of the device
requires continued
operation during
power mains
interruptions, it is
recommended
that the device be
powered from an
uninterruptible
power supply or a
battery.
Power
fre
quency
(50/60
Hz)
magnet
ic field
IEC
61000-
4-8
3A/m
3A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in
a typical commer
cial or hospital
environment.
Note: UT is the AC mains voltage prior to applica
tion of the test level.
Guidance and manufacturer's declara
tion – electromagnetic immunity –for
ME equipment and ME systems that
are not life supporting
Guidance and manufacturer’s declaration – elec
tromagnetic immunity
The device is intended for use in the electromag
netic environment specified below. The customer
or the user of the device should assure that it is
used in such an environment.
IMMUNI
TY test
IEC
60
601
TES
T
LEV
EL
Com
pli
anc
e
lev
el
Electromagnetic
environment - guid
ance
Conduct
ed RF
IEC
61000-4
-6
3
Vrms
150
kHz
to
80
MHz
3
Vrms
Radiated
RF
IEC
61000-4
-3
3
V/m
80
MHz
to
2.5
GHz
3
V/m
Portable and mobile
RF communications
equipment should be
used no closer to any
part of the device,
including cables, than
the recommended
separation distance
calculated from the
equation applicable to
the frequency of the
transmitter.
Recommended sepa
ration distance:
d = 1.167
Ö
P
d = 1.167
Ö
P
80 MHz to
2.5 GHz
d = 2.333
Ö
P
800 MHz
to 2.5 GHz
where
P
is the maxi
mum output power
rating of the transmit
ter in watts (W)
according to the trans
mitter manufacturer
and
d
is the recom
mended separation
distance in metres (m).
Field strengths from
fixed RF transmitters,
as determined by an
electromagnetic site
survey (a), should be
less than the compli
ance level in each fre
quency range (b).
Interference may occur
in the vicinity of equip
ment marked with the
following symbol: