Chapter 2: Safety Information and Alerts
26 MRIdian® system L-0009 Release 4.5 ViewRay Inc.
represent the entire system and not only those components of the system that are outside of
the RF-shielded room. The test results are only valid with the standard system cabling that is
also the prerequisite for the complete functionality of the system (also including all
components inside the RF-shielded room).
Medical electrical equipment needs special precautions regarding EMC and needs to be
ins
talled and put into service according to the EMC information provided in the
accompanying documents.
Electromagnetic compatibility is the ability of equipment or a system to function satisfactorily
in its
electromagnetic environment without introducing intolerable electromagnetic
disturbance to anything in that environment.
Portable and mobile RF communications equipment can affect medical electrical equipment.
The MRIdian is classified as a large and permanently installed
equipment per IEC 60601-1-2. The exemption according to the
r
equirement 36.202.3b) 9 of this standard has been used and the
equipment was not tested for radiated RF immunity over the entire
frequency range of 80 MHz to 2.5 GHz.
The ViewRay system has been
tested for radiated RF immunity
at the following frequencies:
80 MHz through 1000 MHz, 1.2 GHz and 2.4
Modulation characteristic: sinusoidal 1 KHz, 80% AM
Test Level: 3V/m
Signal generators with amplifier: R&S Logperiodic Antenna with IFI Power
Amplifier 9 KHz to 2080 MHz for 80MHz
through 1000 MHz
Kenwoo d Licensed transmitter range 1.2-1.3
GHz used to test 1.2 G Hz
Linksys licensed transmitter range 2.40-2.48
GHz used to test 2.4 G Hz
Fixed equipment or system cabling, which cannot be removed by the user, is
not listed. This cabling is part of the system and was regarded at all EMC-
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