Medel Elite Handbuch Seite 22

EN
Table 2) Guidance and MANUFACTURER's declaration
ELECTROMAGNETIC IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer's declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment
IEC 60601
IMMUNITY test
test level
Electrostatic ±6 kV contact
discharge (ESD) ±8 kV air
IEC 61000-4-2
Electrical fast ±2 kV for power
transient/burst suplly lines
IEC 61000-4-4 ±1 kV for
input/output
lines
Surge IEC ±1 kV line(s) to
61000-4-5 line(s)
±2 kV line(s) to
earth
Voltage dips, <5% U (>95% dip
T
short interrup- in U ) for 0.5 cycle
T
tions and volta-
40% U (60% dip
ge variations on
T
in UT ) for 5 cycles
power supply
input lines 70% U (30% dip
T
IEC 61000-4-11 in U ) for 25 cycles
T
<5% U (>95% dip
T
in U ) for 5 sec
T
Power frequency 3A/m
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
NOTE U is the a.c. mains voltage prior to application of the test level.
T
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100114_MEDEL ELITE USER MANUAL_REV.00_FEB.2017.indd 43-44
Compliance Electromagnetic
level environment - guidance
±6 kV contact Floors should be wood,
±8 kV air concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
±2 kV for power Mains power quality
supply lines should be that of a typical
commercial or hospital
environment.
±1 kV diffe- Mains power quality should
rential be that of a typical
mode commercial or hospital
environment.
<5% U (>95% dip Mains power quality should
T
in U ) for 0.5 cycle be that of a typical
T
commercial or hospital
40% U (60% dip
environment. If the user
T
in U ) for 5 cycles
of the device requires
T
70% U (30% continued operation during
T
dip in U ) for 25 power mains interruptions,
T
cycles it is recommended that the
device be powered from
<5% U (>95% dip
an uninterruptible power
T
in U ) for 5 sec
supply or a battery.
T
3A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Table 4) Guidance and MANUFACTURER's declaration – electromagnetic IMMUNITY
for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer's declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user should assure that it is used in such an environment.
IMMUNITY test IEC 60601 Compliance
TEST LEVEL level
3 Vrms
Conducted RF
150 kHz to
3 Vrms
IEC 61000-4-6
80 MHz
3 V/m
Radiated RF
80 MHz to
IEC 61000-4-3
3 V/m
2.5 GHz
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.
Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telepho-
a
nes 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 device is used exceeds the applicable RF compliance level above,
the device should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
EN
Electromagnetic environment -
guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the device, including cables,
than the recommended separation distan-
ce calculated from the equation appli-
cable to the frequency of the transmitter.
Recommended separation distance:
d=1.2 √ P
d=1.2 √ P 80 MHz to 800MHz
d=2.3√P 800 MHz to 2,5 GHz
where P is the maximum output power ra-
ting of the transmitter in watts (W) accor-
ding to the transmitter manufacturer and d
is the recommended separation distance
in metres (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.
b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
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