Riester ri-former Instructions D'utilisation page 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
RF-Emissionen
CISPR 11 Group 1
RF-Emission
Class B
CISPR 11
Harmonic emissions
Pass
IEC 61000-3-2
Voltage fluctuations/
flicker emissions Pass
IEC 61000-3-3
22
Guidance and manufacture's declaration – electromagnetic immunity
The ri-former
magnetic environment specified below. The customer or the user of
ri-former
environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
Power frequency
(50Hz/60Hz) magnetic
field
IEC 61000-4-8
NOTE: U
Electromagnetic en-
vironment – guidance
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.
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.
Diagnostic Station is intended for use in the electro-
®
Diagnostic Station should assure that it is used in such an
®
IEC 60601 Compliance
test level level
Con: ± 8 kV Con: ± 8 kV
Air: ± 15 kV Air: ± 15 kV
5/50 ns, 100 5/50 ns, 100 kHz;
kHz; ±2 kV ±2 kV
1.2/50 (8/20) µs 1.2/50 (8/20) µs
LtL: ± 1.0 kV LtL: ± 1.0 kV
LtG: ± 2.0 kV LtG: ± 2.0 kV
0 % UT for 0 % UT for 0.5
0.5 cycle (1 cycle (1 phase)
phase) 0 % UT for 1 cycle
0 % UT for 1 70 % UT for 25/30
cycle cycles (50/60 Hz)
70 % UT for
25/30 cycles
(50/60 Hz)
0 % UT for 0 % UT for
250/300 250/300 cycles
cycles (50/60 (50/60 Hz)
Hz)
30 A/m 30 A/m
50 Hz 50 Hz
is the a.c. mains voltage prior to application of the test level.
T
Electromagnetic
environment -
guidance
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.
The quality of the
supply voltage should
be that of a typical
business or hospital
environment.
The quality of the
supply voltage should
be that of a typical
business or hospital
environment.
Mains frequency ma-
gnetic fields should
be at a level charac-
teristic of a typical
location in a typical
commercial hospital
environment.