Emc Information - Respironics Millennium M10 Manual Del Paciente

EMC Information

Guidance and Manufacturer's Declaration – Electromagnetic Emissions
This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure
that it is used in such an environment.
Emissions Test
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/Flicker Emissions
IEC 61000-3-3
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure
that it is used in such an environment.
Immunity Test IEC 60601 Test Level
Electrostatic ±6 kV Contact
Discharge (ESD) ±8 kV Air
IEC 61000-4-2
Electrical Fast ±2 kV for Power Supply
Transient/Burst
IEC 61000-4-4 ±1 kV for Input/Output
Surge ±1 kV Line to Line
IEC 61000-4-5 ±2 kV Line to Ground
Voltage Dips, Short <5% U T (>95% Dip in U T )
Interruptions and
Voltage Variations on
Power Supply Input 40% U T (60% Dip in U T )
Lines
IEC 61000-4-11
70% U T (30% Dip in U T )
<5% U T (>95% Dip in U T )
Power Frequency 3 A/m
(50/60 Hz) Magnetic
Field
IEC 61000-4-8
Note: U T is the A.C. mains voltage prior to application of the test level.
Lines
Lines
for 0.5 Cycle
for 5 Cycles
for 25 Cycles
for 5 Seconds
Compliance
Group 1
Class B
Class A
Complies
Compliance Level
±6 kV Contact
±8 kV Air
±2 kV for Power Supply
Lines
Not Applicable
±1 kV Line to Line
±2 kV Line to Ground
<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 Seconds
3 A/m
Electromagnetic Environment - Guidance
The 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.
The Device is suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network
that supplies buildings used for domestic
purposes.
Electromagnetic Environment - Guidance
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Mains power quality should be that of a typical
home or hospital environment.
Mains power quality should be that of a typical
home or hospital environment.
Mains power quality should be that of a typical
home or hospital environment. If the user of
the Device requires continued operation during
power mains interruptions, it is recommended
that the Device be powered from an
uninterruptible power supply or battery.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical home or hospital environment.