operation manual

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 ÖP
d = 1.167 ÖP 80 MHz to
2.5 GHz
d = 2.333 ÖP 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: