8
5.2
E N/IEC
6 0601-‐1-‐2
T able
2
Guidance
a nd
M anufacturer's
D eclaration
–
E lectromagnetic
I mmunity
The
B ioSonic®
U S100R
u nit
i s
i ntended
f or
u se
i n
t he
e lectromagnetic
e nvironment
s pecified
below.
T he
c ustomer
o r
t he
e nd
u ser
o f
t he
B ioSonic®
U S100R
u nit
s hould
a ssure
i t
i s
u sed
o nly
i n
such
a n
e nvironment.
Immunity
T est
Electromagnetic
d ischarge
(ESD)
IEC
6 1000-‐4-‐2
Electrical
f ast
transient/burst
IEC
6 1000-‐4-‐4
Surge
IEC
6 1000-‐4-‐5
Voltage
d ips,
s hort
interruptions
a nd
v oltage
variations
o n
p ower
s upply
input
l ines
IEC
6 1000-‐4-‐11
Power
f requency
( 50/60Hz)
magnetic
f ield
IEC
6 1000-‐4-‐8
Note
U T
i s
t he
a .c.
m ains
v oltage
p rior
t o
a pplication
o f
t he
t est
l evel.
IEC60601
t est
Compliance
L evel
Intended
E lectromagnetic
level
+-‐
6 kV
c ontact
+-‐
6 kV
c ontact
+-‐
8 kV
a ir
+-‐
8 kV
a ir
+-‐2kV
f or
p ower
+-‐2kV
f or
p ower
supply
l ines
supply
l ines
+-‐1kV
f or
+-‐1kV
f or
input/output
l ines
input/output
lines
+-‐1kV
d ifferential
+-‐1kV
d ifferential
mode
( line-‐line)
mode
( line-‐line)
+-‐2kV
c ommon
+-‐2kV
c ommon
mode
( line-‐earth)
mode
( line-‐earth)
<5%
U T
( >95%
d ip
<5%
U T
( >95%
in
U T)
f or
0 .5
c ycle
dip
i n
U T)
f or
0 .5
cycle
40%
U T
( 60%
d ip
in
U T)
f or
5
c ycles
40%
U T
( 60%
d ip
in
U T)
f or
5
c ycles
70%
U T
( 30%
d ip
in
U T)
f or
2 5
70%
U T
( 30%
d ip
cycles
in
U T)
f or
2 5
cycles
<5%
U T
( >95%
d ip
in
U T)
f or
5
<5%
U T
( >95%
seconds
dip
i n
U T)
f or
5
seconds
3A/m
3A/m
BioSonic Ultrasonic Scaler
Environment
Floors
s hould
b e
w ood,
concrete
o r
c eramic
t ile.
If
f loors
a re
c overed
w ith
synthetic
m aterial,
t he
relative
h umidity
s hould
be
a t
l east
3 0%.
Mains
p ower
q uality
should
b e
t hat
o f
a
t ypical
commercial
o r
h ospital
environment.
Mains
p ower
q uality
should
b e
t hat
o f
a
t ypical
commercial
o r
h ospital
environment.
Mains
p ower
q uality
should
b e
t hat
o f
a
t ypical
commercial
o r
h ospital
environment.
I f
t he
u ser
of
t he
B ioSonic®
U S100R
unit
r equires
c ontinued
operation
d uring
p ower
mains
i nterruptions,
i t
i s
recommended
t hat
t he
BioSonic®
U S100R
u nit
b e
powered
f rom
a n
uninterruptible
p ower
supply
w ith
s ufficient
capacity
t o
r un
t he
u nit
for
t he
m aximum
required
t ime
o f
interruption.
Power
f requency
magnetic
f ields
s hould
b e
at
l evels
c haracteristic
o f
a
t ypical
l ocation
i n
a
typical
c ommercial
o r
hospital
e nvironment.