FAN LactoFAN2 - Electromagnetic Compatibility Declaration

Manual LactoFAN2 25 of 30
Manufacturer declaration of electromagnetic compatibility of H
2
breath test device
“LactoFAN2”
(tables 1, 2, 4 and 6 according to DIN EN 60601-1-2:2007)
Table 1 Guidelines and manufacturer declaration – Electromagnetic emission
The „LactoFAN2“is intended for use in an electromagnetic environment as described below.
The customer or user of the „LactoFAN2“should ensure that the device is used in such an environment.
Emission Measurements
Accordance
ELECTROMAGNETIC ENVIRONMENT - GUIDELINES
HF emissions acc. to CISPR11
Group 1
The „LactoFAN2“uses HF energy exclusively for its
internal function. Thus the HF emission is very low
and it is unlikely that nearby electronic devices would
be disturbed.
HF emissions acc. to CISPR11
Class B
The device is intended for use in all facilities including
living quarters and such ones which are connected
directly to a public power supply that supplies also
buildings used for living purposes.
Table 2 Guidelines and manufacturer declaration – Electromagnetic immunity
The „LactoFAN2“is intended for use in an electromagnetic environment as described below.
The customer or user of the „LactoFAN2“should ensure that the device is used in such an environment.
INTERFERENCE RESISTANCE
TEST
IEC 60601-
TESTING LEVEL
ACCORDANCE LEVEL
ELECTROMAGNETIC ENVIRONMENT - GUIDELINES
ELECTROSTATIC DISCHARGE
(ESD) ACC. TO IEC 61000-4-2
±6 kV contact
discharge
±6 kV
contact discharge
Floors should be of wood, concrete or
ceramic tiles. If the floor is tiled with synthetic
material the relative air humidity must have 30
% at least.
± 8kV air discharge
±8 kV air discharge
Magnetic field at the supply
frequency (50/60 Hz) acc. to
IEC 61000-4-8
3 A/m
3 A/m
Magnetic fields at the supply frequency
should conform to the typical values as they
occur in the business or clinic environment.