Empi Continuum - Guidance and Manufacturers Declaration-Electromagnetic Immunity

44 Continuum User’s Manual
Product Information (Clinician)
Guidance and Manufacturer’s Declaration–Electromagnetic
Immunity
The Empi Continuum is intended for use in the electromagnetic environment
specified in the table below. The user of the Empi Continuum 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
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
supply lines
±1 kV for input/
output lines
Not Applicable-
Battery Operated Device
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
Not Applicable-
Battery Operated Device
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
) for
5 cycles
70% U
T
(30% dip in U
T
) for
25 cycles
<5% U
T
(>95% dip in U
T
)
for 5 sec
Not Applicable-
Battery Operated Device
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Empi Continuum requires
continued operation during
power mains interruptions, it
is recommended that the Empi
Continuum be powered from an
uninterrupted power supply or
a battery.
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical location
in a typical commercial or hospital
environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.