AirSep VisionAire 5 Gebrauchsanweisung Für Patienten Seite 83

VisionAire™
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.
IEC 60601 test
IMMUNITY test Compliance level
level
Electrostatic ± 6 kV contact ± 6 kV contact
discharge (ESD)
± 8 kV air ± 8 kV air
IEC 61000-4-2
Electrical fast ± 2 kV for power ± 2 kV for power supply
transient/burst supply lines lines
IEC 61000-4-4 ± 1 kV for Not Applicable
input/output lines
Surge ± 1 kV line to line ± 1 kV line to line
IEC 61000-4-5 ± 2 kV line to ± 2 kV line to earth
earth
Voltage dips, short <5 % U <5 % U
T
interruptions and (>95 % dip in U ) (>95 % dip in U
T
voltage variations for 0,5 cycle for 0,5 cycle
on power.
40 % U 40 % U
T
(60 % dip in U ) (60 % dip in U
IEC 61000-4-11
T
for 5 cycles for 5 cycles
70 % U 70 % U
T
(30 % dip in U ) (30 % dip in U
T
for 25 cycles for 25 cycles
<5 % U <5 % U
T
(>95 % dip in U ) (>95 % dip in U
T
for 5s for 5 s
Power frequency 3 A/m 3 A/m
magnetic field
IEC 61000-4-8
NOTE U T is the a.c. mains voltage prior to application of the test level.
®
AirSep Corporation
MN137-1 rev. D
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
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
T
) commercial or hospital environment. If the user
T
of the VisionAire requires continued operation
during power mains interruptions, it is
recommended that the VisionAire be powered
T
)
from an uninterruptible power supply (UPS) or
T
a battery.
T
)
T
T
)
T
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
EN EN
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
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
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.
EN-25 EN-26
IEC 60601 TEST LEVEL Compliance level
3 Vrms 3 Vrms Portable and mobile RF communications equipment
150 kHz to 80 MHz should be used no closer to any part of the VisionAire
including cables, than the recommended separation
distance calculated from the equation applicable to
3 V/m 3 V/m the frequency of the transmitter.
80 MHz to 2.5 GHz
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
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
VisionAire™
Electromagnetic environment ± guidance
a
b
®
AirSep Corporation
MN137-1 rev. D