Emc Information; Guidance And Manufacturer's Declaration - Electromagnetic Emissions - DeVilbiss Healthcare DV6WM Guía De Instrucciones

EMC INFORMATION

(per IEC 60601-1-2:2007 Section 5.2.1.1)
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the
EMC information provided in this instruction guide.
Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT
(per IEC 60601-1-2:2007 Section 5.2.2.1 c)
Guidance and Manufacturer's Declaration –
Electromagnetic Emissions
The DeVilbiss DV6WM Wireless Modem is intended for use in the
electromagnetic environment specified below. The customer or the
user of the DeVilbiss DV6WM Wireless Modem should assure that it
is used in such an environment.
Emissions Test Compliance
RF Emissions
Group 2
CISPR 11
RF Emissions
Class B
CISPR 11
Harmonics IEC
Class A
61000-3-2
Voltage Fluctuations/
Flicker Emissions Complies
IEC 61000-3-3
SE-DV6WM-1
Electromagnetic Environment –
Guidance
This device uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
This device is suitable for use in all
establishments including domestic,
and those directly connected to the
public low-voltage power supply
network that supplies buildings used
for domestic purposes.
(per IEC 60601-1-2:2007 Section 5.2.2.1 f)
Immunity Test IEC 60601 test level
Electrostatic
±8kV contact
discharge (ESD)
±15kV air
IEC 61000-4-2
±2 kV for power supply
Electrical fast
lines
transient/burst
±1 kV for input/output
IEC 61000-4-4
lines
Surge ±1 kV line(s) to line(s)
IEC 61000-4-5 ±2 kV line(s) to earth
>95 % dip in UT for 0.5
Voltage dips, short cycle
interruptions and 60 % dip in UT for 5
voltage variations cycles
on power supply 30 % dip in UT for 25
input lines cycles
IEC 61000-4-11 >95 % dip in UT for 5
seconds
Power frequency
(50/60 Hz)
30 A/m
magnetic field
IEC 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Electromagnetic Environment
Compliance level – Guidance
Floors should be wood, concrete
or ceramic tile. If floors are
±8kV contact
covered with synthetic material,
±15kV air
the relative humidity should be at
least 30 %.
±2 kV for power
Mains power quality should be
supply lines
that of a typical commercial or
±1 kV for input/output
hospital environment.
lines
Mains power quality should be
±1 kV line(s) to line(s)
that of a typical commercial or
±2 kV line(s) to earth
hospital environment.
Mains power quality should be
that of a typical commercial or
>95 % dip in UT for
hospital environment. If the user
0.5 cycle
of the DeVilbiss DV6WM
60 % dip in UT for 5
Wireless Modem requires
cycles
continued operation during power
30 % dip in UT for 25
mains interruptions, it is
cycles
recommended that DeVilbiss
>95 % dip in UT for 5
DV6WM Wireless Modem be
seconds
powered from an uninterruptible
power supply or a battery.
Power frequency magnetic fields
should be at levels characteristic
30 A/m of a typical location in a typical
commercial or hospital
environment.
EN - 11