inCourage RespirTech - Electromagnetic Immunity; Guidance and Manufacturers Declaration

Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity
The inCourage
®
Airway Clearance Therapy, Model ICS-1M-US-A, is intended for
use in the electromagnetic environment specified below. The user of the inCourage
System should assure that it is used in such an environment.
Electrostatic
discharge (ESD)
IEC 61000-4-4
±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%.
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
A
A
A
A
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
inCourage System requires continued
operation during power mains
interruptions, it is recommended
that the inCourage System be
powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
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 AC mains voltage prior to application of the test level.
IMMUNITY
TEST
IEC 60601
TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT GUIDANCE
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-11
±1 kV differential
mode
±2 kV common
mode
Mains power quality
should be that of a typical
commercial or hospital
environment.
A
A
C
A
N/A
A
A
ELECTROMAGNETIC IMMUNITY
31
inCourage
®
Airway Clearance Therapy | INSTRUCTION MANUAL