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CONTENTS
Im
Immunity test
m
u
i n
y t t y
e t t e
t s
IE
IEC 60601-1-2
C
Test level
Te
s
l l t
Vo
Voltage dips, short
l
l
a t
e g
d
i d
p i
, s
h s
h
o
t r
< 5% UT (> 95% of dip in
<
5
%
int
interruptions and
e t
r r
rr
up
ti p
o o n
s n
a an
d n
UT) for 1/2 cycle
UT
)
vol l t
voltage variations on
t
ag
e
v
r a a r
t a a t i
o i
s n
o
n
n
40% UT (60% of dip in
40
%
po
power supply input
w
r e
u s
ppl
y
n i
put
t
UT) for 5 cycle
UT
)
lin
lines
s e
70
70% UT (30% of dip in
%
IE
IEC 61000-4-11
C
6
0 1
0 0
-4-11
UT
UT) for 25 cycle
)
< 5% UT (> 95% of dip in
<
5
%
UT) for 5 sec
UT
)
Po
Power frequency
w
r e
r f f r
q e
u
n e
y c
3 A/m
3
A
/
(50/60 Hz) magnetic
(5
/ 0
0 6
H
) z z )
m
a
n g
e e t
c i t
fi
fi
field
e
e
d l
d l
IE
IEC 61000-4-8
C
6
0 1
0 0
-4-8
Conducted RF
Co
n
u d
t c
d e
R
F
3
3 Vrms,
V
r
IE
IEC 61000-4-6
C
6
0 1
0 0
-4-6
150 KHz to 80 MHz
15
0
R
Radiated RF
ad
at i
ed
R
F
3
3 V/m,
V
/
IE
IEC 61000-4-3
C
6
0 1
0 0
-4-3
80
80 MHz to2.5 GHz
M
Note 1. UT is the a.c. mains voltage prior to application of the test level.
No
e t
1
.
U
T
i
t s
e h
a
c .
. c
m
i a
s n
o v
No
Note 2. At 80 MHz and 800 MHz, the higher frequency range applies.
e t
2
.
A
t t 8
0 8
M
H
z
n an
a
d d 8
8
0 0
M
No
Note 3. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflections
e t
3
.
T
e h
e s
u g
d i
i l e
n i
s e
m
a
y y n
from structures, objects and people
fr
o
m
t t r s
u r
t c
tu
r u
s e
o ,
b b j
e j
c
s t
a a n
d n
e p
a
a
Field strength from mixed transmitters, such as base stations for radio telephones and land mobile radios, amateur radio, AM
F
ie
d l
tr s
n e
g
h t
f f r
o r
m
m
ix
d e
r t t r
or FM broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
or
F
M
b
o r
d a
a c
t s
a a n
d n
T
V
r b
a o
c d
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in
to
fi
f
x i
d e
R
F
r t
a a n
s n
m
m
tt i
e tt
, s r
n a
l e
wh
which the BioSway Balance is used exceeds the applicable RF compliance levels above, the BioSway Balance should be observed
c i
t h
e h
B
o i
S
wa
y
B
B
l a
n a a n
e c
s i
to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
to
to
v
v
i r r e
i r e
r
y f
y f f y
fy
n
n
r o o r
r o o r
m
m
a a
a a
o l
o l
e p
e p
a r
a r
a a t
i t t i a a t
o i t t i
n o
. n
f I
f I
b a a b
b a a b
re
relocating the BioSway Balance system.
l
c o
t t i a
n i
t g
e h
B
o i
S
w
w
y a
B
l a
n a
b
b
Ov
Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
e
t r
e h
r f f r
q e
u
n e
y c
r
n a a n
e g
1
0 5
*Reference test results for details
*R
e
e f f e
e r
nc
t e
s e
r t
s e
ul
s t
s
f f or
or
de
a t
s l i
6
6 0
1 0
-1-2
IEC 60601-1-2
IE
C
6
0
v e
l e
Co
Compliance level
m m p
i l p
li
a a n
U
T
> (
5 9
%
f o
d d
p i
n i
< 5% UT (> 95% of dip
<
5
%
U
o f f o
1 r
2 / / 2
c c
c y y c
e l
in UT) for 1/2 cycle
in
UT T
)
U
T
( ( 60
60
%
f o
di i p
p
n i
in
40% UT (60% of dip
40
%
U
T
f f o
r o
5
c
c y
e l
in
in UT) for 5 cycle
UT
)
U
T
( ( 30
30
%
f o
di i p
p
in
n i
70% UT (30% of dip
70
%
U
T
f f o
r o
5 2
c
c y y c
e l
in
in UT) for 25 cycle
UT
)
U
T
> (
5 9
%
f o
d d
p i
n i
<
< 5% UT (> 95% of dip in
5
%
U
T
f f o
r o
5
s
c e
UT) for 5 sec *
UT
)
f f o
r o
m
3 A/m
3
A
/
m
m
, s
3
3 Vrms,
V
r
m
, s
K
H
z
o t
80
M
H
z
150KHz to 80 MHz
15
0
K
H
m
,
3
3 V/m,
V
/
m
,
H
z
to2.
5
G
H
z
80
80 MHz to2.5 GHz
M
H
Se
See Risk Analysis
Se
e
R
R
i
i
Report *
Re
p
o
t r
a t l
e g
p
i r
r o
o t
p a ap
p
c i l
c
t a
o i
n
f o
h t
t e
H
z
, t
e h
i h
h g
r e
r f fr
q e
u
u
n e
y c
r
n a
e g
n
t o
p a ap
l p
y y i
n i
l l a a
i s
u t t u
i t t i a
i
n o
. s
l E
c e
t t r
o r
p o
e l
a a n
s n
m
itt
e
, s r
u s
h c
s a
a b
a
e s
s
t ta
o i
s n
s a
c t
a a n
n n
t o
e b
r p
d e
t c i
t
d e
h t t h
o e
e r
c i t
c e
tr
o
m
g a
e n
c i t t
i s
e t
s
r u
v r
y e
s
o h
u
ld
s u
d e
x e
e c
d e
t s
e h
ap
p p
p
c i l
b a a b
e l
R
F
n
n
r o
r o
m
m
a a l
a a l
p l
p l
r e
r e
f f o
f f o
r o
r o
m
m
n a a n
n a a n
e c
e c
s i
s i
b o
b o
e s
e s
v r
v r
d e
d e
e c
s
s y
e t
m
.
K
Hz
o t t o
8
0
M
Hz
,
f f i
e i
e
d l
t t r s
e r
g n
t t h
s h
— E-3 —
Electromagnetic environment – guidance
El
e
c c t
t t r
o r
m
a a g
gn
n
6
0
1
-1-2
n
c c e
l e
le
v e
l e e l
Ma a
Mains power quality should be that of a typical
i
i
s n
o p
w
r e
T
> (
5 9
%
f o
d d
p i
commercial or hospital environment. If a better
co
m
m
m
e
c r
l a a i
r o
for
f
or
1
2 / / 2
c c
c y y c
e l
ma a
mains power quality is required, it is
i
s n
p
o
w
r e
( ( 60
60
%
f o
di i p
p
recommended that the BioSway Balance is
re
o c
m
m
n e
d d e
d e
f f o
r o
5
c
c yc
e l
pow w e
powered from an uninterruptible power supply
r r e
d e
fr
o
m
( ( 30
30
%
f o
di i p
p
f f o
r o
5 2
c
c yc
e l
> (
5 9
%
f o
d d i
p i
n i
5
s
c e
*
If image distortion occurs, it may be necessary
If
i
m
a
e g
d
s i
o t
to position the BioSway display further from
to
p
s o
i t i
n o
t t h
sources of power frequency magnetic fields or
so
u
c r
s e
f o
f
p
to
to install magnetic shielding. The power
in
t s
l l a a
m
g a
frequency magnetic field should be measured in
fr
q e
u
n e
y c
m
the intended installation location to assure that it
th
e
in
e t
d n
d e
is sufficiently low
is
u s
f f i f f f
c i
e i
t n
y l
Po
Portable and mobile RF communications
t r
ta
b a
e l
a a n
d n
eq
equipment should be used no closer to any part
u
p i
m
en
t
h s
z
to
8
0
M
H
z
of
of the BioSway Balance, including cables, than
t t he
he
B
o i
S
w
the recommended separation distance calculated
th
e
e r
o c
m
m
m
e
z
to
. 2
5
G
H
z
from the equation applicable to the frequency of
fr
o
m
t t h
e h
e
u q q u
th
the transmitter.
th
e
e
tr
tr
an
an
s n
s n
m
m
i
i
e t t
e t t
k s
k
A
A
n
l a
l
s y
i
s i
Re
Recommended separation distance:
o c
m
m
n e
d
*
d = 1.2! P 150 KHz to 80 MHz
d
=
. 1
2!
P
1
d = 1.2! P 80 MHz to 800 MHz
d
=
. 1
2
!
P
80
d
d = 2.3! P 800 MHz to 2.5 GHz
=
. 2
3
!
P
80
where P is the maximum output power rating of
wh
e
e r
P
i
t s
e h
the transmitter in watt (W) according to the
th
e
tr
a
s n
m
tt i
transmitter manufacturer, and d is the
tr
a
s n
m
t t t t i
r e
m
recommended separation distance in meters
re
o c
m
m
e
d n
d e
(m).
(m .
)
Fi
Field strengths from fixed RF transmitters, as
e
d l
r t t r s
n e
gt
h t t h
determined by an electromagnetic site survey,
de
r e t t e
m
i
ne
d
b
sh
should be less than the compliance level in
o
u
d l
e b
e l
each frequency range.
each
r f
fr
q e
u
en
Interference may occur in the vicinity of
In
t
r e
fe
r
n e
e c
equipment marked with the following symbol:
eq q u
ui
p i i p
m
en
t
m
s e
l t
v e
. l e
p a ap
p
e i l
. s
m
g a
e n
c i t
r p
p o
g a
t a a t
i t t
n o
s i
a
f f f
e f f e
t c
d e
o f f o
r r
d a a d
io
te
le
p
o h
e n
s e
a
d n
la
d n
m
l a a
y l
i w
h t
a
c c
r u
c a
y.
T
o
a
s s
s e
t s
e h
e b
c
n o
i s
e d
e r
. d
f I
th
th
e
m
e
s a
r u
d e
o c
mp
p
i l
n a a n
e c
e l
e v
s l
b a a b
a
v o
, e
t t h
e h
B
o i
a ,
a
d d d
d d d
ti i
ti i
n o o n
n o o n
l a a
l a a
m
m
a e
a e
u s
u s
e r
e r
s e
s e
m
m
y a a y
y a a y
e b
e b
e n
e n
e c
e c
s
o h
u
d l
e b
e l
s s
t t h
a h
n a
3
V/
m
.
e
c i t
n e e n
i v
o r
n
m
n e
t n –
g
i u
a d d a
n
e c
q
u
i l a
i l
y t
ty
h s
h
u o
d l
d l
e b
b
e
h t
h
a a t
o t
a f
f
y t
ty
yp
i p
i
cal
cal
h
s o
i i t p
a a l t
e l
v n
ir
r i
n o
n
m
e
t n n t
I .
a f
be
t t
tt
r e
q
a u
t i l
ty
i y
r s
q e
u
r i
ir
ed
ed
t i ,
s i
h t t h
t a a t
t t h
e h
B
o i
S
w w a
y a a
y
B
l a a l
n a a n
e c
s i
n a
n u
n i
e t t
r r
ru
p u
b i i b t
b
e l
p
o
w
e
s r
p u
p
y l
t r
o i
n
c o
u c
, s r
t i
m
m
y a a
e b
n
c e
s e
sa
e h
B
io
S
w
y a
d
s i
l p
l
y a
f f u
r u
th
r e
r f f r
om
o
w
r e
r f f r
f
q e
u
n e
y c
m
m
g a
n
t e
i t
c i
fi
i f
i f f i
l e
d l
s d
e n
c ti
h s
ie
d l
in
. g
T
T
e h
p
o
w
r e
g a
e n
c i t t i
f f i
e i
d l
h s
u o
u
d l
e b
m
e
s a
r u
d e
in
s
ta a
la l
ti
o
l n
c o
t a a t
io
io
n
to
s a
u s
e r
th
t a a t
lo
w
m
b o
e l i
R
F
o c
m
m
mu
n u
c i
t a a t
o i
s n
u o
d l
e b
s u
d e
o n
l c
s o
er
o t t
n a
y
pa a r
y a
B
l a a
a a nc
nc
e
i ,
nc
u l
di
di
ng
c
b a a b
e l
, s
t t ha
ha a n
d n
d e
s
p e e p
r a a r
t a a t
io
n
d
is
ta a n
n
e c
a c
lc
u
t la a t
d e
i t t i a a t
n o
a a p
p p
c i l
b a a b
e l
o t
t
e h
fr
e
qu
e
nc
y
f o
. r
. r
d e
s
p e
r a a r
i t t i a a t
n o
d
t s i
t
a a n
c n
: e
5
0
K
H
z
to
8
0
M
M
H
z
M
H
z
to
8
0
0
M
M
H
z
0
M
H
z
to 2. G
5
G
H
z
m
a
i x
mu
u
m
u o
t t p
u p
t u
o p
we
r r
i t t i a a t
g n
of
r e
in
w
t a
( t
W
)
c a
c
o c
d r
in
g
to
th
e
n a
u
f f a
c a
u t
e r
, r
n a
d
d
d
is
t t h
e h
s
p e
a a ra
ra
i t t
n o
d
s i
ta
a t
n a a n
e c
n i
m
e
e t
rs
f s
fr
o r
m
f
fi
x i
d e
RF
R
F
a r t t r
a a n
s n
m
i
tt
e t t
, s r
s a
y
n a a n
l e
c e
t t r
o r
m
a
gn
gn
e
c i t t i
s
e t i
s
ur
ve
y
ss
h t t h
n a
t t h
e h
o c
m
p
p
i l
n a
e c
le
v
l e
in
b
b
y c
a r
n .
ge
m
y a
o
c c
r u
n i
t t h
e h
v
i c i
i n
n
y t
f o
ar
k
ed
w
h t t h i
t t h
e h
f f o
l l o
ll
o
i w w
g n
y s
ym
m
bol
:
b
y
b a a b
o s
p r
i t t i
n o
n a
d n
e r
fl c e
l f
ti
o
s n
b o
ile
a r
i d
s o
a ,
m
a
t at
u e
r r
d a
io
,
AM
l e
c e
t t r
o r
m
g a
e n
c i t t
e
n e
i v
ro
n
m
n e
d t
e u
i f
fi
el
d
r t t r s
n e
g
h t t h
n i
th
th
e
lo
c
ti a
n o
n i
S
w
y a a
B
l a
n a a n
e c
h s
h
u o
d l
e b
ob
s
e e r
v r
s s
s s
r a a r
r a a r
y,
y,
u s
u s
h c
h c
s a
s a
e r
e r
or
or
or
or
e i
e i
nt t
nt t
i
i
ng
ng
or
or
APPENDIX E
y r
or
n i
t i
t r
rt
n
a
a
,
d e
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