VIEWRAY MRIdian System 4.5 - Page 47

ViewRay Inc. MRIdian® system L-0009 Release 4.5 29
Chapter 2: Safety Information and
IEC60601-1-2 Tables 4, 8- Electromagnet
Immunity test IEC 60601 Test
Level
Compliance
Level
Electromagnetic environment – guidance
Conducted
D
isturbances,
Induced by RF
Fields
IEC 61000-4-6
3 V RMS
0.15 MHz to
80 MHz
3 V RMS N/
A
Radiated RF
Electroma
gnetic
Fields
IEC 61000-4-3
3V/m
80MHz to
2.5 GHz
3V/m 80 MHz to 1000 MHz:
d = 1.0 √P
1.2GHz to 2.4 GHz:
d = 0.1√P
where P is the maximum output power rating of
the transmit
ter in watts (W)*
according to the transmitter manufacturer and
d is
the recommended separation
distance in meters (m). Fi
eld strengths from
fixed RF transmitters, as determined
by an electromagnetic site survey,
should be
less than the compliance level in
each frequency range. Inte
rference may occur in
the vicinity of equipment marked
with the following symbol:
ic Immunity
Note 1: At 80 MHz and 1000 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all si
tuations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Note 3: It is essential that the actual shielding effectiveness and filter attenuation of the
shielded loc
ation be verified to ensure that they meet the minimum specification.
* 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 outside the shielded location in which the
MRIdian system is used exceeds [field strength] V/m, the MRIdian system should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as relocating the MRIdian system or using a shielded
location with a higher RF shielding effectiveness and filter attenuation.