Bayer HealthCare Certegra, Operation Manual

Page: 102 / 104

MEDRAD
®
Stellant CT Injection System with Certegra
®
Workstation
18 - 94
Guidance and manufacturer's declaration - electromagnetic immunity
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 Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6 3Vrms from 150kHz to 80 MHz at 80% AM 1kHz
6Vrm, 80% AM 1kHz at ISM frequencies listed below: 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
Radiated RF
IEC 61000-4-3 3Vrms from 80 MHz to 2.7 GHz at 80% AM 1kHz
and specific ISM bands listed below:
d = 1.17 80 MHz to 800 MHz
d = 2.33 800 MHz to 2.7 GHz
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 deter-
mined 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:
Non-ionizing Radiation Symbol (IEC TR
60878, 5140)
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 electromag-
netic 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.
Frequency
(MHz-ISM List)
Test Level
(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
Frequency
(MHz)
Modulation
Type
Modulation
Frequency
Field
Strength
(Volts/meter)
385 Pulse 18 Hz 27
450 Pulse 18 Hz 28
710 Pulse 217 Hz 9
745 Pulse 217 Hz 9
780 Pulse 217 Hz 9
810 Pulse 18 Hz 28
870 Pulse 18 Hz 28
930 Pulse 18 Hz 28
1720 Pulse 217 Hz 28
1845 Pulse 217 Hz 28
1970 Pulse 217 Hz 28
2450 Pulse 217 Hz 28
5240 Pulse 217 Hz 9
5500 Pulse 217 Hz 9
5785 Pulse 217 Hz 9