Medicap Precise 6000, Operation Manual

Page: 33 / 58

Rev. D 2018-11 32
Regulations and declaration of manufacturer- Electromagnetic compatibility, interference
emission
The
Précise 6000
is intended for use in an environment as described below. The operator of the
Précise 6000
must make sure that the unit is operated in such an environment.
Immunity test
IEC/EN 60601-
test level
Compatibility
level
Electromagnetic environment -
regulations
Discharge of static
electricity (ESD)
acc. to
IEC/EN 61000-4-2 +/- 6kV contact
discharge
+/- 8kV
Air discharge +/- 6kV contact
discharge
+/- 8kV Air
discharge Floors should be made of wood or
concrete or should be covered with
ceramic the floor is covered with
synthetic materials, the relative
humidity must be at least 30%.
fast transient
electric
interference /
bursts acc. to
IEC 61000-4-4 +/- 2kV for mains
leads
+/- 1kV for input /
output leads +/- 2kV for mains
leads
+/- 1kV for input /
output leads The quality of the supply voltage
should match the typical office or
hospital environment.
Surge voltage acc.
to
IEC/EN 61000-4-5 +/-1kV Push - pull
+/-2kV asymme-
trical voltage +/-1kV Push - pull
+/-2kV asymme-
trical voltage The quality of the supply voltage
should match the typical office or
hospital environment.
Voltage dips,
shortterm
interruptions and
fluctuations in
supply voltage acc.
to IEC 6100-4-11 >5% Ut
(>95% dip in Ut) for
½ period
40% Ut
(60% dip in Ut) for
5 period
70% Ut
(30% dip in Ut) for
25 period
>5% Ut
(>95% dip in Ut) for
5 s >5% Ut
(>95% dip in Ut)
for ½ period
40% Ut
(60% dip in Ut) for
5 period
70% Ut
(30% dip in Ut) for
25 period
>5% Ut
(>95% dip in Ut)
for 5 s The quality of the supply voltage
should match the typical office or
hospital environment.
Magnetic field at a
supply frequency
(50/60Hz) acc. to
IEC 61000-4-8 3 A/m 3 A/m Magnetic fields at mains frequency
must comply with the typical vales
found in office or hospital
environments.
Note: Ut is the a.c. supply voltage before application of the test levels.