Table of Contents
Advertisement
For Model BD-X201ME
Supplement for medical Use
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided in the Accompany-
ing documents.
Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT.
WARNING : The use of ACCESSORIES, transducers and cables other than those specified,with the exception
of transducers and cables sold by the manufacturer of the EQUIPMENT or SYSTEM as replacement
parts for internal components ,may result in increase EMISSIONS or decreased IMMUNITY of the
EQUIPMENT or SYSTEM.
Information of Cables and Accessories
Make sure to use specified Accessories as described below, in order to complied with IEC60601-1-2.
Note : Please refer to a part of "SAFETY PRECAUTIONS" ( page
tions.
WARNING : The EQUIPMENT or SYSTEM should not be used adjacent to or stacked with other equipment and
that if adjacent or stacked use is necessary,the EQUIPMENT or SYSTEM should be observed to
verify normal operation in the configuration in which it will be used.
WARNING : The use of ACCESSORY, transducer and cable with EQUIPMENT and SYSTEM other than those
specified may result in increase EMISSIONS or decreased IMMUNITY of the EQUIPMENT or SYS-
TEM.
Guidance or Manufacturer's declaration-electromagnetic emissions
The Model BD-X201ME is intended for use in the electromagnetic environment specified below.
The customer or the user of the Model BD-X201ME should assure that it is used in such an environment.
Emission Test
Compliance
RF emissions
Group 1
CISPR11/EN55011
RF emissions
Class B
CISPR11/EN55011
Harmonic emissions
Class A
IEC/EN 61000-3-2
Voltage Fluctuations/
Complies
Flicker emissions
IEC/EN 61000-3-3
)
and "Accessories (page 75) in the Instruc-
Electromagnetic environment-guidance
The Model BD-X201ME uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
The Model BD-X201ME is suitable for use in all
establishments,including domestic establishments and
those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
Guidance or Manufacturer's declaration-electromagnetic immunity
The Model BD-X201ME is intended for use in the electromagnetic environment specified below.
The customer or the user of the Model BD-X201ME should assure that it is used in such an environment.
IEC/EN 60601
Immunity Test
Test Level
Electrostatic dis-
+/- 6 kV:Contact
charges(ESD)
+/- 8 kV:Air
IEC/EN 61000-4-2
Electrical fast
+/- 2 kV:AC mains
Transients/burst
+/- 1 kV:Signal lines
IEC/EN 61000-4-4
Surge
+/- 2 kV :Common mode
IEC/EN 61000-4-5
+/- 1 kV :Differential mode
Voltage dips, short
<5 % Ut
interruptions and
(>95 % dip in 100 V and
voltage variations
240 V) : for 0.5 cycle
on power supply
input lines
40 % Ut
(60 % dip in 100 V and
240 V) : for 5 cycles
IEC/EN 61000-4-11
70 % Ut
(30 % dip in 100 V and
240 V) : for 25 cycles
<5 % Ut
(>95 % dip in 100 V and
240 V) : for 5 s
Power frequency
3 A/m
(50 Hz/60 Hz)
Magnetic Field
IEC/EN 61000-4-8
Note : Ut is the nominal a.c. mains voltage.
Electromagnetic
Compliance Level
environment-guidance
Floor should be wood, concrete or
+/- 6 kV:Contact
ceramic tile. If floors are covered
with synthetic material, the relative
+/- 8 kV:Air
humidity should be at least 30 %.
Mains power quality should be that
+/- 2 kV:AC mains
of a typical commercial or hospital
environment.
+/- 1 kV:Signal lines
Mains power quality should be that
of a typical commercial or hospital
+/- 2 kV :Common mode
environment.
+/- 1 kV :Differential mode
Mains power quality should be that
<5 % Ut
of a typical commercial or hospital
(>95 % dip in 100 V and
enviroment. If the user of the Model
240 V) : for 0.5 cycle
BD-X201ME requires continued
operation during power mains in-
40 % Ut
terruptions, it is recommended that
(60 % dip in 100 V and
the Model BD-X201ME be pow-
240 V) : for 5 cycles
ered from an uninterruptible power
supply or a battery.
70 % Ut
(30 % dip in 100 V and
240 V) : for 25 cycles
<5 % Ut
(>95 % dip in 100 V and
240 V) : for 5 s
If image distortion occurs, it may
be necessary to position the Model
3 A/m
BD-X201ME further from sources
of power frequency magnetic fields
or to install magnetic shielding.
The power frequency magnetic
field should be measured in the in-
tended installation location to as-
sure that it is sufficiently low.
Advertisement
Table of Contents
