Handling Of Electromagnetic Interactions; List Of All Cables And Transformers Replaceable By The User - Lowenstein Medical Allegra M30 Mode D'emploi

8 EMC information
Power supply DC
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
6V in ISM bands and amateur
radio bands between
0.15 MHz and 80 MHz
80 % AM at 1 kHz
Electrical transient ISO 7637-2 see ISO 7637-2
conduction along
supply lines
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Patient connection
Phenomenon Test method Immunity test levels
Electrostatic discharge IEC 61000-4-2 ±8 kV contact
±15 kV air
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
Signal input and output channels
Phenomenon Test method Immunity test levels
Electrostatic discharge IEC 61000-4-2 ±8 kV contact
±15 kV air
Fast transient electrical IEC 61000-4-4 ±1 kV
disturbances/bursts 100 kHz repetition frequency
Impulse voltages/ IEC 61000-4-5 ±2 kV line-to-ground
surges
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

8.2 Handling of electromagnetic interactions

Although electromagnetic interference of the secretion aspirator
Allegra M30 has been reduced to a minimum, electromagnetic disturbanc-
es between the secretion aspirator Allegra M30 and other devices
cannot be excluded. Therefore you should comply with the specified require-
ments and instructions regarding the permissible electromagnetic environment
at any case and monitor the secretion aspirator Allegra M30 in order
to ensure proper operation and to prevent adverse events for patients and
users. Select another location for the secretion aspirator Allegra M30,
if the permissible electromagnetic environment cannot be ensured or if you
have observed functioning of the secretion aspirator Allegra M30 or
of another device in the vicinity that is not intended.
Since electromagnetic propagation is affected by absorption and reflection
from structures, objects and people and since the field strength from fixed
transmitters cannot be predicted in advance with accuracy, a site survey of
the electromagnetic phenomena at the location at which the secretion
aspirator Allegra M30 shall be operated should be considered to
assess the existing electromagnetic environment at this location. If unusual
performance is detected, additional measures may be required, for example a
modified orientation or another location of the secretion aspirator
Allegra M30. If the essential features of the secretion aspirator
Allegra M30 are impaired by electromagnetic disturbances, a reduced or
non-existent flow rate and vacuum may be expected.
8 EMC information

8.3 List of all cables and transformers replaceable by the user

Name Specification Maximum length
Power Type: GTM91099-6015-3.0-T2 1.20 m
supply unit incl. Manufacturer: GlobTek
connecting cable Technical data:
100-240 V~, 50-60 Hz, 1.5 A (in)
12 V DC, 5 A (out)
Mains cable Type: H03VVH2-F 1.80 m
Manufacturer: HAWA
Technical data: 250 V~, 2.5 A
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