AirSep VisionAire 5 Patient Manual - page 83
VisionAire™
EN
AirSep
®
Corporation
EN-25
MN137-1 rev. D
Specifications continued
Medical equipment needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided in
this section.
Guidance and manufacturer’s declaration ± electromagnetic immunity
The VisionAire is intended for use in the electromagnetic environment specified below. The customer or the user of the
VisionAire 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
± 2 kV for power supply
lines
Not Applicable
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV line to line
± 2 kV line to
earth
± 1 kV line to line
± 2 kV line to earth
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power.
IEC 61000-4-11
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
U
T
(>95 % dip in U
T
)
for 5s
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
U
T
(>95 % dip in U
T
)
for 5 s
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the VisionAire requires continued operation
during power mains interruptions, it is
recommended that the VisionAire be powered
from an uninterruptible power supply (UPS) or
a battery.
Power frequency
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.
EN
VisionAire™
EN-26
AirSep
®
Corporation
MN137-1 rev. D
Guidance and manufacturer’s declaration ± electromagnetic immunity
The VisionAire is intended for use in the electromagnetic environment specified below. The customer or the user of the
VisionAire should assure that it is used in such an electromagnetic environment.
IMMUNITY test
IEC 60601 TEST LEVEL
Compliance level
Electromagnetic environment ± guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the VisionAire
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
D= 1.2 x
√P
D= 1.2 x
√P from 80MHz to 800MHz
D= 2.3 x
√P from 800MHz to 2.5GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
a
should be less than the compliance level in each
frequency range.
b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the VisionAire is used exceeds the applicable RF
compliance level above, the VisionAire should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the VisionAire.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.