Supplement for medical use – JVC BD-X201M User Manual

Page 44

Supplement for medical Use

For Model BD-X201ME

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

III)

and “Accessories (page 75) in the Instruc-

tions.

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.

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.

Guidance or Manufacturer’s declaration-electromagnetic emissions

RF emissions

CISPR11/EN55011

Group 1

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.

IEC/EN 61000-3-3

RF emissions

CISPR11/EN55011

Harmonic emissions

IEC/EN 61000-3-2

Voltage Fluctuations/

Flicker emissions

Class A

Class B

Complies

The customer or the user of the Model BD-X201ME should assure that it is used in such an environment.

The Model BD-X201ME is intended for use in the electromagnetic environment specified below.

Emission Test

Electromagnetic environment-guidance

Compliance

Guidance or Manufacturer’s declaration-electromagnetic immunity

Immunity Test

IEC/EN 60601

Test Level

Compliance Level

Electromagnetic

environment-guidance

Electrostatic dis-

charges(ESD)

IEC/EN 61000-4-2

IEC/EN 61000-4-4

IEC/EN 61000-4-5

IEC/EN 61000-4-11

IEC/EN 61000-4-8

Surge

Voltage dips, short

interruptions and

voltage variations

on power supply

input lines

Electrical fast

Transients/burst

3 A/m

Power frequency

(50 Hz/60 Hz)

Magnetic Field

3 A/m

+/- 6 kV:Contact

+/- 8 kV:Air

+/- 2 kV:AC mains

+/- 1 kV:Signal lines

+/- 6 kV:Contact

+/- 8 kV:Air

Floor should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30 %.

+/- 2 kV:AC mains

+/- 1 kV:Signal lines

Mains power quality should be that
of a typical commercial or hospital
environment.

Mains power quality should be that
of a typical commercial or hospital
enviroment. If the user of the Model
BD-X201ME requires continued
operation during power mains in-
terruptions, it is recommended that
the Model BD-X201ME be pow-
ered from an uninterruptible power
supply or a battery.

If image distortion occurs, it may
be necessary to position the Model
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.

<5 % Ut
(>95 % dip in 100 V and
240 V) : for 0.5 cycle

40 % Ut
(60 % dip in 100 V and
240 V) : for 5 cycles

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