Renovia leva - Page 48

Guidance and manufacturer’s declaration – electromagnetic
immunity
The leva Pelvic Health System is intended for use in the
electromagnetic environment specified below. The
customer or the user of the leva Pelvic Health System
should assure that it is used in such an environment.
IMMUNITY
test
IEC 60601
test level
Compliance
level
Electromagnetic
environment
–
guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±6 kV
contact
±8 kV air
±6 kV
contact
±8 kV air 1
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material, the
relative humidity
should be at least 30
%.
Electrical
fast
transient
/burst
IEC
61000-4-
4
±2 kV for
power
supplylines
±1 kV for
input/outp
utlines
Not
applicable 2
Mains power
quality should be
that of a typical
commercial or
hospital
environment.
Surge
IEC 61000-4-5
±1kV
line(s) to
line(s)
±2 kV
line(s) to
earth
Not
applicable 3
Mains power quality
should be that of a
typical commercial or
hospital environment.
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