Emc Information; Electromagnetic Environment In Which The Secretion Aspirator Allegra M30 May Be Operated - Lowenstein Medical Allegra M30 Mode D'emploi

8 EMC information

WARNING: The use of the secretion aspirator Allegra M30
directly adjacent to or stacked with other devices should be avoided, since this
could lead to impermissible operation. If the use of the secretion
aspirator Allegra M30 adjacent to or stacked with other devices is
required, the secretion aspirator Allegra M30 and the other devices
should be monitored in order to verify proper operation in this arrangement!
WARNING: The use of accessories and spare parts, transformers
and cables for the secretion aspirator Allegra M30 not
indicated or provided by Heinen + Löwenstein GmbH & Co. KG may
increase the electromagnetic emissions or reduce the electromagnetic
immunity of the secretion aspirator Allegra M30, resulting in
impermissible operation. No warranty is provided for damages caused
by using accessories and spare parts, transformers and cables
not recommended or by improper use. Only use original accessories
and spare parts!
WARNING: The use of the indicated or provided accessories and
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spare parts, transformers and cables for other devices than the
secretion aspirator Allegra M30 may increase the electromag-
76 netic emissions or reduce the electromagnetic immunity. No warranty
is provided for damages caused by using the indicated or provided
accessories and spare parts, transformers and cables with other devices
or by improper use. Only use the accessories and spare parts, trans-
formers and cables with the secretion aspirator Allegra M30!
WARNING: Portable and mobile RF communication equipment
(incl. peripheral devices such as antenna cables and external antennas)
may influence medical electrical devices and therefore should not be
used within a range of 30 cm of any part of the secretion
aspirator Allegra M30 incl. its cables. Otherwise the performance
of the device may be impaired.
WARNING: The secretion aspirator Allegra M30 may
influence other devices, examinations and treatments electromagnet-
ically. For this reason, special attention should always be paid to other
devices and examinations or treatments performed in parallel so that
any influence is detected as quickly as possible.
The secretion aspirator Allegra M30 meets the requirements of
IEC 60601-1-2 / EN 60601-1-2 "Electromagnetic Compatibility - Medical
Electrical Equipment" without deviations or restrictions. Therefore electromag-
netic interference is reduced to a minimum. Follow the indicated instructions
and guidelines to sustain the basic safety and the essential features of the
secretion aspirator Allegra M30 over its entire service life.
8.1 Electromagnetic environment in which the secretion
aspirator Allegra M30 may be operated
The secretion aspirator Allegra M30 is intended for operation in the
electromagnetic environment specified below, in which the RF disturbances are
controlled. The customer or the user of the secretion aspirator
Allegra M30 must ensure that it is operated in such an environment.
The environments for intended operation include professional healthcare
institutions and the home care environment. Special environments, such as the
proximity of RF surgery or MRI resp. environments in which the intensity of the
EMC disturbances is high, are excluded.
Emission limits
Conducted and radia- CISPR 11
ted RF emissions
Harmonic distortion IEC 61000-3-2
Voltage fluctu- IEC 61000-3-3
ations/flicker
Housing
Phenomenon Test method Immunity test levels
Electrostatic discharge IEC 61000-4-2 ±8 kV contact
±15 kV air
Radiated RF IEC 61000-4-3 28 V/m
disturbances 80 MHz to 6 GHz
80 % AM at 1 kHz
Magnetic field at IEC 61000-4-8 30 A/m
rated power
frequency (50 Hz)
8 EMC information
Power supply AC
Phenomenon Test method Immunity test levels
Fast transient electrical IEC 61000-4-4 ±2 kV
disturbances/bursts 100 kHz repetition
frequency
Impulse voltages/ IEC 61000-4-5 ±1 kV line-to-line
surges ±2 kV line-to-ground
Conducted RF distur- IEC 61000-4-6 3 V
bances 0.15 MHz to 80 MHz
6 V in ISM bands and amateur
radio bands between
0.15 MHz and 80 MHz
80 % AM at 1 kHz
Voltage dips IEC 61000-4-11 0 % U for ½ period
T
At 0°, 45°, 90°, 135°, 180°,
225°, 270°, 315°
0 % U for 1 period
T
70 % U for 25 periods
T
one-phase at 0°
Voltage IEC 61000-4-11 0 % U for 250 cycles
T
interruptions
Note: U is the AC mains voltage prior to the application of the test levels.
T
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