Chapter 2: Safety Information and Alerts
28 MRIdian® system L-0009 Release 4.5 ViewRay Inc.
The MRIdian system should ONLY be used with manufacturer-labeled MR-Safe
equipment. MR-Safe equipment has no significant influence on the quality of
imag
e information from the MR system. Furthermore, the characteristics of
the MR-Safe equipment are not affected by the MR system.
Guidance and Manufacturer’s Declaration of Electromagnetic Immunity
IEC60601-1-2 Table 2 Guidance and Manufacturer's Declaration—Electromagnetic Immunity
Immunity test IEC 60601 Test
Level
Compliance Level Electromagnetic environment –
gu
idance
Immunity-
Electrosta
tic
Discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete
or ceramic
tile. If floors are
covered with synthetic material,
the relative
humidity should be at least
30 %.
Electrical Fast
Transients and
Bu
rsts
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for signal
li
nes > 3m
±2 kV for power
supply lines
±1 kV for signal
lin
es
Mains power quality should be
that of a typical commercial or
hospital environment.
Surges
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mo
de
±1 kV differential
mode
±2 kV common
mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage Dips
and Short
Interruptions
IEC 61000-4-11
0% V
Nom
- 0.5
cycle
40% V
Nom
-5 cycle
70% V
Nom
-25
cycle
0% V
Nom -
5 sec.
0% V
Nom
-0.5 cycle
40% V
Nom
-5 cycle
70% V
Nom
-25 cycle
0% V
Nom
– 5 sec.
Standard applies to equipment
rated <
16 Amps, for the MRIdian
system this is the treatment
delivery and planning console
only. As delivered with the
MRIdian system, both consoles
are connected to an
uninterruptible power supply.
Power
F
requency (50/
60 Hz) magnetic
field IEC 61000-
4-8
3 A/m 3A/m Power frequency magnetic fields
sh
ould be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
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