Bayer HealthCare MEDRAD Stellant Operation And Installation Manual page 26

The system is intended for use in the electromagnetic environment specified below. The customer or user of the system should assure that it is used in such
an environment.
Immunity test IEC 60601 Test Compliance Level
Conducted RF 3Vrms from 150kHz to 80 MHz at 80% AM 1kHz
IEC 61000-4-6 6Vrm, 80% AM 1kHz at ISM frequencies listed below:
Radiated RF 3Vrms from 80 MHz to 2.7 GHz at 80% AM 1kHz and specific ISM
IEC 61000-4-3 bands listed below:
Frequency
(MHz)
385
450
710
745
780
810
870
930
1720
1845
1970
2450
5240
5500
5785
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 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 system is used exceeds the applicable RF
compliance level above, the system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the system.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
®
MEDRAD Stellant ISI 700 Module Operation and Installation Manual
Guidance and manufacturer's declaration - electromagnetic immunity
Frequency Test Level
(MHz-ISM List) (Vrms)
1.8 - 2.0 6
3.5 - 4.0 6
5.3 - 5.4 6
6.765 - 6.795 6
7.0 - 7.3 6
10.1- 10.15 6
13.553 - 13.567 6
14.0 - 14.2 6
18.07 - 18.17 6
21.0 - 21.4 6
24.89 - 24.99 6
26.957 - 27.283 6
28.0 - 29.7 6
40.66 - 40.70 6
50.0 - 54.0 6
Modulation Modulation
Type Frequency
Pulse 18 Hz
Pulse 18 Hz
Pulse 217 Hz
Pulse 217 Hz
Pulse 217 Hz
Pulse 18 Hz
Pulse 18 Hz
Pulse 18 Hz
Pulse 217 Hz
Pulse 217 Hz
Pulse 217 Hz
Pulse 217 Hz
Pulse 217 Hz
Pulse 217 Hz
Pulse 217 Hz
Electromagnetic environment - guidance
WARNING: Portable RF communications equipment
(including peripherals such as antenna cables and
external antennas) should be used no closer than 30
cm (12 inches) to any part of the injection system
unless a greater separation distance is required as
indicated by the equation. Otherwise, degradation of
the performance of this equipment could result.
Recommended separation distance
d = 1.17
d = 1.17
Field d = 2.33
Strength
(Volts/meter)
Where p is the maximum output power rating of the
27
transmitter in watts (W) according to the transmitter
28
manufacturer and d is the recommended separation
9
distance in meters (m).
9
9 Field strengths from fixed RF transmitters, as
28
determined by an electromagnetic site survey,
28
be less than the compliance level in each frequency
28 b
range.
28
Interference may occur in the vicinity of equipment
28
marked with the following symbol:
28
28
9
Non-ionizing Radiation Symbol (IEC TR
9
60878, 5140)
9
20
80 MHz to 800 MHz
800 MHz to 2.7 GHz
a
should