Table of Contents
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CONTENTS
declaratIon of conformIty
Em
Emissions
i
s s
o i
n
s
Ma
Manufacturer's declaration electromagnetic emissions
n
u u f
a f f a
t c c t
r u
r e
s '
d
c e
c
la
a l
a r
t t i
o i
n
Th
The BioSway Balance is intended for use in the electromagnetic environment specified below. The customer or the user of
e
B
o i
S
w
y a a
B
l a
a a n
c n
c
i e
i s
n n t
e t
the BioSway Balance system should assure that it is used in such an environment
th
e
B
io
S
w
y a
B
l a a
n a a n
e c
e
s
s y
e t
m
Em
Emission test
i i s
s s
o i i o
n
t t e
e e s
t s
Compliance
Co
RF emissions
RF
e
m
mi
i
s s
o i
s n
Gr
Group 1
CI
CI
CISPR 11
S
S
P
P
R
R
1
1
1
1
RF emissions
RF
e
m
s is
o i
s n
Cl
Class A
CISPR 11
CI
S
P
R
1
1
Ha a r
Harmonic distortion
r
m
n o
c i
d
s i
o t
t r
rt
io
n
Cl
Class A
a
EN
EN 61000-3-2
6
1
0
0
0
-3-2
Vo
Voltage fluctuations
a t l
e g
fl
l f
c u
u t t u
a a t
o i t t
s n
Complies
Co
and flicker
an
d
i l f
fl
ck
r e
EN 61000-3-3
EN
6
0 1
0 0
-3-3
Immunity
Im
m
u
i n
y t
Ma
Manufacturer's declaration electromagnetic immunity
n
u u f
a f f a
t c c t
r u
r e
s '
d
c e
c
a l
la
a r
t t i
o i
n
Th
The BioSway Balance is intended for use in the electromagnetic environment specified below. The customer or the user of
Th
e
e
B
B
o i
o i
S
S
w
w
y a a
y a a
B
B
l a
l a
a a n
a a n
c n
c n
c
c
i e
i e
i s
i s
n n t
n n t
e t
e t
the BioSway Balance system should assure that it is used in such an environment.
th
e
B
io
S
w
y a
B
l a a
n a a n
e c
e
s
s y
e t
m
Im
Immunity test
m
u
i n
y t t y
e t t e
t s
IEC 60601-1-2
IE
C
Test level
Te
t s
El
Electrostatic discharge
e
t t r c
r r o
s o
a a t t
ta
c i t
d d
s i
h c c h
a a r
g r
e g
± 6 kV contact
±
6
(E
(ESD)
S
D
)
±
± 8 kV air
8
IEC 61000-4-2
IE
C
6
0 1
0 0
-4-2
El
Electrical fast
e
r t t r c
ri
c i
l a a l
a f f a
t s
±
± 2 kV for power lines
2
transients/burst
tr
n a a n
si
n e
s t
b /
u
st r
± 1 kV for input/output
±
1
lines
lin
lin
IE
IE
IEC 61000-4-4
C
C
6
6
0 1
0 1
0 0
0 0
-4-4
4 4
Surge
Su
r
e g
±
± 1 kV differential mode
1
IE
IEC 61000-4-5
C
6
0 1
0 0
-4-5
±
± 2 kV common mode
2
*
* Reference test results for details
R
e
f f e
r e
n e
e c
e t
t s
e r
u s
t l
s t
f f or
or
de
APPENDIX E
e
le
c c tr
tr
o
m
a a g
gn
n
e
c i t
ti
e e m
m
s i i s
s s
o i i o
s n
d n
d e
f f o
r o
u
e s
n i
t t h
e h
l e
c e
t c
o r
m
g a
e n
h s
u o
d l
s a
u s
e r
h t
t a a t
t i
s i
s
s u
d e
n i
m m p
p
l l i
a i
n
e c
El
Electromagnetic environment
c e
o
p u
1
Th
The BioSway Balance system generates RF energy only for its internal
e
fu u n
fu
functions. Therefore, its RF emission is very low and is not likely to
c n
cau
cause any interference in nearby electronic equipment
e s
a
s s
A
Th
The BioSway Balance system is suitable for use in all
e
es
establishments other than domestic and those directly connected to the
t
b a
pu u bl
public low-voltage power supply network supplying buildings used
i bl
for domestic purposes.
fo
r
s s
A
m
p
l
i l
s e
e
e l
c c t
t t r
o r
m
a a
gn
n
e
c i t
i i m
m
m
m
u
n
y t t y i
d n
d n
d e
d e
f f o
f f o
r o
r o
u
u
e s
e s
n i
n i
t t h
t t h
e h
e h
l e
l e
c e
c e
t c
t c
o r
o r
m
m
g a
g a
e n
e n
h s
u o
d l
s a
u s
e r
h t
t a a t
t i
s i
s
s u
d e
n i
6
6 0
1 0
-1-2
IE
IEC 60601-1-2
C
l l e
v e
l e
Co
Compliance level
m m p
k
V
co
t n
tac
ac
t
Contact ± 6 kV
Co
n n t
kV
a
r i
Air ± 8 kV *
Ai
r
Power ± 2 kV
Po
w
kV
f f or
or
p
o
w
e
l r
n i
s e
Si
Signal ± 1 kV
n g
kV
f f or
or
i
np
ut
o / / o
ut t p
p
t u
s e
kV
di
f f f
e f f e
e r
t t n
l a i
m
od
e
± 1 kV diff. mode
±
1
k
V
o c
m
m
n o
m
o
e d
± 2 kV com. mode
±
2
a t
s l i
c i t
e
v n
r i
n o
m
n e
s t
e p
i c
i f i
fi
d e
e b
o l
u s
h c
n a a n
n e
v
r i
n o
m
e
t n
tr
o
m
a a g
g
n
e e t
c i t
ti
e
v n
ir
o
n
m
m
e e n
t n
B
o i
S
w
y a a
B
l a a
n a a n
e c
y s
t s
e t t e
m
g
n e
r e
ti
ti
n o
. s
T
T
e h
h
e r
f
o f f o
, e r
i
ts i
R
R
R
R
F
F
e
m
is
is
s
io
io
an
y
n i
er t t er
f f e
r e
en
e c
n i
e n
n
ar
b
y
l e
B
o i
S
w
y a
B
l a
n a a n
e c
s
s y
e t t
m
s i
u s
i l
h s
m
n e
s t
o
h t t h
r e
th
n a a n
d
o d d o
m
s e
ic t
l
l c
ow
-
vo
a t l
e g
po
w
e
s r
u s
ppl
y
ne
o d
m
s e
c i t t i
p
r u
pos
e
. s
c i t
c i t
e
e
v n
v n
r i
r i
n o
n o
m
m
n e
n e
s t
s t
e p
e p
i c
i c
i f i
i f f i i
fi
d e
d e
e b
e b
o l
o l
u s
h c
n a a n
n e
v
r i
n o
m
e
t n
.
El
El
Electromagnetic environment – guidance
e
c c t
t t r
o r
m
a a
6
0
6
0
1
-1-2
i l p
li
a a n
c c n
l e
le
v e
l e e l
a a t
t c
±
6
k k V
V
Fl
Fl
Floor should be wood, concrete or ceramic
o
r o
h s s h
u u o
±
8
k
V
*
tiles. If floor is covered with synthetic
ti
le
. s
If
f I
f
flo
material, the relative humidity should be at
ma
ma a t
e t
r
i r
, l a a
t t h
least 30%
le
le
a
t s
30%
r e
±
2
k
V
Ma
Ma a i
Mains power quality should be that of a
i
s n
o p
w
l a
±
1
k
V
ty
typical commercial or hospital environment
yp
y
i p
cal
co
m
k
V
i d
. f f . f f f
m
o
e d
Ma a i
Mains power quality should be that of a
Ma
i
s n
o p
w
ty yp
typical commercial or hospital environment
y
i p
cal
co
m
k
V
o c
m
.
m
o
e d
— E-2 —
. w
T
e h
c
s u
o t
m
r e
r o
h t t h
e h
s u
r e
f o
t a a t
s e
R
F
e
e n
g r
y
n o
y l
f f o
f f o
r o
t i
i s
n n t
e t t e
rn
n r
n
is
is
e v
y r
l
o l
w
a a n
d n
d
i
s i
o n
l t
l
ik
ik
e
y l
l
ec
r t t r
n o
c i
eq
u
p i
m
en
t
t i
b a a b
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f f o
r o
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n i
l l a
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th
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d
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ir
t t l c
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nn
n n
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d e
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t t h
w t t w
o
k r r k
s
p u
pl
i y y i
g n
bu
l i
di
di
n
gs
s u
d e
. w
w
T
T
e h
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c
c
s u
s u
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m
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o
r o
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r
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s u
r e
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f o
f o
gn
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e
t n
–
–
g
i u
a d d a
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d l
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w
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c n
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a a m
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lo
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v o
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th
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t n
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l e
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m
i
i d
ty
y t
s
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u o
d l
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r e
q
u
i l a
ty
y t
h s
u o
d l
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h t
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a a t
o t
a f
m
er
c
l a i
r o
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s o
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al t
en
en
v
r i
n o
m
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q
u
i l a a l
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h t t h
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er
c
l a i
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en
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v
r i
n o
m
en
l a a l
to
e h
c i
ic t
t a a t
t
t
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