23
22
Appendix
Appendix
Not applicable
Not applicable
Not applicable
Table 2 – Guidance and
MANUFACTURER
’
S
declaration – electromagnetic
IMMUNITY
–
for all
ME EQUIPMENT
and
ME SYSTEMS
Compliance level
Electromagnetic environment
–
guidance
±
6 kV contact
±
8 kV air
r
o
e
t
e
r
c
n
o
c
,
d
o
o
w
e
b
d
l
u
o
h
s
s
r
o
o
l
F
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30
%.
a
f
o
t
a
h
t
e
b
d
l
u
o
h
s
y
ti
l
a
u
q
r
e
w
o
p
s
n
i
a
M
typical commercial or hospital
environment.
±
1 kV line(s) to
line(s)
±
2 kV line(s) to earth
a
f
o
t
a
h
t
e
b
d
l
u
o
h
s
y
ti
l
a
u
q
r
e
w
o
p
s
n
i
a
M
typical commercial or hospital
environment.
<5
%
U
T
(>95
%
dip in
U
T
)
for 0,5 cycle
40
%
U
T
(60
%
dip in
U
T
)
for 5 cycles
70
%
U
T
(30
%
dip in
U
T
)
for 25 cycles
<5
%
U
T
(>95
%
dip in
U
T
)
for 5 s
s
d
l
e
if
c
it
e
n
g
a
m
y
c
n
e
u
q
e
rf
r
e
w
o
P
m
/
A
3
m
/
A
3
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
NOTE
U
T
is the a.c. mains voltage prior to application of the test level.
Mains power quality should be that
of a typical commercial 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.
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
I
MMUNITY
test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
IEC 60601
test level
±
6 kV contact
±
8 kV air
±
2 kV for power
supply lines
±
1 kV for input/output
lines
Not applicable
Table 4 – Guidance and
MANUFACTURER
’
S
declaration – electromagnetic
IMMUNITY
–
for
ME EQUIPMENT
and
ME SYSTEMS
that are not
LIFE
-
SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
I
MMUNITY
test
IEC 60601
TEST
LEVEL
Compliance
level
Electromagnetic environment
–
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 V/m
Recommended separation distance
P
V
=
d
]
5
,
3
[
1
P
=
d
2.333
800 MHz to 2,5 GHz
where
P
is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and
d
is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as deter-
mined by an electromagnetic site survey,
a
should be
less than the compliance level in each frequency
range.
b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the device is used exceeds
the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [
V
1] V/m.
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
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.
P
=
d
80 MHz to 800 MHz
1.167
