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Guidance
and
Declaration
‐
electromagnetic
immunity
The
models
device
intended
for
use
in
the
electromagnetic
environment
specified
below.
The
customer
or
the
user
of
the
device
should
assure
that
they
are
used
in
such
an
environment.
Immunity
test
IEC
60601
test
level
Compliance
level
Electromagnetic
environment
‐
guidance
Electrostatic
discharge
(ESD)
lEC
61000
‐
4
‐
2
±8
kV
contact
±2
kV,
±4
kV,
±8
kV,
±15
kV
air
±8
kV
contact
±2
kV,
±4
kV,
±8kV,
±15
kV
air
Floors
should
be
wood,
concrete
orceramic
tile.
If
floors
are
coveredwith
synthetic
material,
the
relativehumidity
should
be
at
least
30
%.
Electrical
fast
transient/burs
t
IEC
61000
‐
4
‐
4
±2kV
for
power
supplylines
±1
kV
for
Input/outputlines
±2kV
for
powersupply
lines
Mains
power
quality
should
be
thatof
a
typical
commercial
or
hospitalenvironment.
Voltage
dips,
short
interruptions
and
voltage
variations
on
power
supply
input
lines
IEC
61000
‐
4
‐
11.
<5
%
UT
(>95%
dip
in
UT.)
for
0.5
cycle
<5
%
UT
(>95%
dip
in
UT)
for
1
cycle
70%
UT
(30%
dip
in
UT)
for
25/30
cycles
<5%
UT
(>95
%
dip
in
UT)
for
5/6
sec
<5
%
UT
(>95%
dip
in
UT.)
for
0.5
cycle
<5
%
UT
(>95%
dip
in
UT)
for
1
cycle
70%
UT
(30%
dip
in
UT)
for
25/30
cycles
<5%
UT
(>95
%
dip
in
UT)
for
5/6
sec
Mains
power
quality
should
be
thatof
a
typical
commercial
or
hospitalenvironment.
If
the
user
of
themodel
P08
require
continuedoperation
during
power
mainsinterruptions,
it
is
recommendedthat
the
model
P08
poweredfrom
an
uninterruptible
powersupply
or
a
battery.
Power
frequency
(50/60
Hz)
magnetic
field
lEC
61000
‐
4
‐
8
30
A/m
30
A/m
Power
frequency
magnetic
fieldsshould
be
at
levels
characteristic
ofa
typical
location
in
a
typicalcommercial
or
hospitalenvironment.
NOTE
UT
is
the
a.c.
mains
voltage
prior
to
application
of
the
test
level.
Conducted
RFlEC
61000
‐
4
‐
6
3
Vrms
150
kHz
to
80
MHz
6
Vrms
in
ISM
andamateur
radiobands
3
Vrms
150
kHz
to
80
MHz
6
Vrms
in
ISM
andamateur
radiobands
Portable
and
mobile
RF
communicationsequipment
should
be
used
no
closer
to
any
part
ofthe
models
P08
including
cables,
than
therecommended
separation
distance
calculated
fromthe
equation
applicable
to
the
frequency
of
thetransmitter.
Recommended
separation
distance
d=[3,5/V1]x
P
1/2
Radiated
RFlEC
61000
‐
4
‐
3
10
V/m
80
MHz
to
2.7
GHz.
10
V/m
80
MHz
to
2.7
GHz
d=1,2xP
1/2
80
MHz
to
800
MHz
d=2,3xP
1/2
800
MHz
to
2.7
GHz
385MHz
‐
5785MHz
TestspecificationsforENCLOSUREP
ORTIMMUNITY
toRF
wirelesscommunicationequipmen
t(Refer
to
table9
of
IEC
60601
‐
1
‐
2:2014)
385MHz
‐
5785MHz
Testspecificationsfor
ENCLOSUREPORTIMMUNIT
Y
toRF
wirelesscommunicationeq
uipment(Refer
to
table9
of
IEC
60601
‐
1
‐
2:2014)
where
P
is
the
maximum
output
power
rating
of
thetransmitter
In
watts
(W)
according
to
the
transmittermanufacturer
and
d
Is
the
recommendedseparation
distance
in
meters
(m).
Field
strengths
from
fixed
RF
transmitters,
asdetermined
by
an
electromagnetic
site
survey,
a
should
be
less
than
the
compliance
level
in
eachfrequency
range.
b
Interference
may
occur
In
the
vicinity
of
equipmentmarked
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
andland
mobile
radios,
amateur
radio,
AM
and
FM
radio
broadcast
and
TV
broadcast
cannot
be
predictedtheoretically
with
accuracy.
To
assess
the
electromagnetic
environment
due
to
fixed
RF
transmitters,
anelectromagnetic
site
survey
should
be
considered.
If
the
measured
field
strength
in
the
location
in
whichthe
models
P06Ais
used
exceeds
the
applicable
RF
compliance
level
above,
the
model
P06A
should
be
observed
to
verify
normal
operation.
If
abnormal
performance
is
observed,
additional
measuresmay
be
necessary,
such
as
reorienting
or
relocating
the
model
P06A.
b) Over
the
frequency
range
150
kHz
to
80
MHz,
field
strengths
should
be
less
than
3V/m.
15