22
Attention!
Medical electrical equipment is subject to special precauti-
ons regarding electromagnetic compatibility (EMC).
Portable and mobile radio frequency communication de-
vices can affect medical electrical equipment. The ME de-
vice is for operation in an electromagnetic environment and
intended for professional facilities such as industrial areas
and hospitals.
The user of the device should ensure that it is operated wit-
hin such an en-vironment.
Warning!
The ME device may not be stacked, arranged or used directly
next to or with other devices. When operation is required to
be close to or stacked with other devices, the ME device and
the other ME devices must be observed in order to ensure
proper operation within this arrangement. This ME device
is intended for use by medical professionals only. This ME
device is intended for use inProfessional Healthcare Facility
Environment. This device may cause radio interference or
interfere with the operation of nearby devices. It may be-
come necessary to take appropriate corrective measures,
such as redirecting or rearranging the ME device or shield.
The rated ME device does not exhibit any basic performance
features in the sense of IEC 60601-1, which would present
an unacceptable risk to patients, operators or third parties
should the power supply fail or malfunction.
Warning!
Portable RF communications equipment (radios) including
accessories, such as antenna cables and external antennas,
should not be used in closer proximity than 30 cm (12 inch-
es) to parts and cables of the Diagnostic station ri-former
specified by the manufacturer. Failure to comply may result
in a reduction in the device‘s performance features.
Directives and manufacturer‘s declaration - Electromagne-
tic emissions
The Diagnostic station ri-former are intended for use in the
electromagnetic environment specified below. The custo-
mer or user of the Diagnostic station ri-former should en-
sure that it is used in such an environment.
Guidance and manufacture’s declaration – electromagnetic emission
The
ri-
former
®
Diagnostic Station intended for use in the electromagnetic
environment specified below. The customer of the user of the Diagnostic
station ri-former should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic en-
vironment – guidance
RF-Emissionen
CISPR 11
Group 1
The
ri-
former
®
Dia-
gnostic Station uses
RF energy only for its
internal function. The-
refore, its RF emissi-
ons are very low and
are not likely to cause
any interference in ne-
arby electronic equip-
ment.
RF-Emission
CISPR 11
Class B
The
ri-
former
®
Dia-
gnostic Station is in-
tended for use in all
establishments, inclu-
ding residential areas
and those directly
connected to a public
supply network that
also supplies buildings
used for residential
purposes.
Harmonic emissions
IEC 61000-3-2
Pass
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Pass
Guidance and manufacture’s declaration – electromagnetic immunity
The
ri-
former
®
Diagnostic Station is intended for use in the electro-
magnetic environment specified below. The customer or the user of
ri-
former
®
Diagnostic Station should assure that it is used in such an
environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic
environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Con: ± 8 kV
Air: ± 15 kV
5/50 ns, 100
kHz; ±2 kV
Con: ± 8 kV
Air: ± 15 kV
5/50 ns, 100 kHz;
±2 kV
Floors should be wood,
concrete or ceramic
tile. If floor are covered
with synthetic material,
the relative humidity
should be at least 30%.
The quality of the
supply voltage should
be that of a typical
business or hospital
environment.
Surge
IEC 61000-4-5
1.2/50 (8/20) µs
LtL: ± 1.0 kV
LtG: ± 2.0 kV
1.2/50 (8/20) µs
LtL: ± 1.0 kV
LtG: ± 2.0 kV
The quality of the
supply voltage should
be that of a typical
business or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
0 % UT for
0.5 cycle (1
phase)
0 % UT for 1
cycle
70 % UT for
25/30 cycles
(50/60 Hz)
0 % UT for 0.5
cycle (1 phase)
0 % UT for 1 cycle
70 % UT for 25/30
cycles (50/60 Hz)
The quality of the
supply voltage should
be that of a typical
business or hospital
environment.
0 % UT for
250/300
cycles (50/60
Hz)
0 % UT for
250/300 cycles
(50/60 Hz)
Power frequency
(50Hz/60Hz) magnetic
field
IEC 61000-4-8
30 A/m
50 Hz
30 A/m
50 Hz
Mains frequency ma-
gnetic fields should
be at a level charac-
teristic of a typical
location in a typical
commercial hospital
environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
