Manufacturer's EMC declaration
18
Page 31
Table 1:
Guidelines and manufacturer’s declaration –
Electromagnetic emissions
The Z
Lipo
Med
device is intended to be used in an electromagnetic environment as indicated below. The customer
or user of the Z
Lipo
Med
device must ensure that it is used in such an environment.
Interference emission
measurements
Compliance
Electromagnetic environment
–
Guidelines
HF emitted interference according
to CISPR 11
Group 1
The Z
Lipo
Med
device must emit electromagnetic
energy to guarantee its intended function. Electronic
devices located in the vicinity may be impaired.
HF emitted interference according
to CISPR 11
Class A
The Z
Lipo
Med
device is suitable for use in all
establishments, including domestic establishments,
and in those which are connected directly to the
public grid which also supplies buildings used for
residential purposes.
Harmonic emissions according to
IEC 61000-3-2
Class A
Voltage fluctuations/flickers
according to IEC 61000-3-3
Complies
Table 2:
Guidelines and manufacturer’s declaration –
Electromagnetic immunity
The Z
Lipo
Med
device is intended to be used in an electromagnetic environment as indicated below. The customer
or user of the Z
Lipo
Med
device must ensure that it is used in such an environment.
Immunity tests
IEC 60601
–
test level
Compliance level
Electromagnetic environment
–
Guidelines
Electrostatic
discharge (ESD)
according to IEC
61000-4-2
± 8 kV contact
discharge
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air discharge
± 8 kV contact discharge
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air discharge
Floors should be made of wood,
concrete or ceramic tiles. In the
case of plastic coverings, the
relative humidity must be at
least 30%.
Rapid electrical
transients/bursts
according to IEC
61000-4-4
± 2 kV
100 kHz repetition
frequency
± 2 kV
100 kHz repetition frequency
The quality of the supply voltage
must correspond to that of a
typical business or hospital
environment.
Surges
according to IEC
61000-4-5
(external
conductor
–
external
conductor)
± 0.5 kV, ± 1 kV
± 0.5 kV, ± 1 kV
Surges
according to IEC
61000-4-5
(external
conductor
–
± 0.5 kV, ± 1 kV, ± 2 kV
± 0.5 kV, ± 1 kV, ± 2 kV