VIEWRAY MRIdian System 4.5 - Page 45

ViewRay Inc. MRIdian® system L-0009 Release 4.5 27
Chapter 2: Safety Information and
considerations. Without this cabling there is no complete functionality of the system.
The use of accessories, transducers and cables other than those
specified, with the exception of transducers and cables sold by the
manuf
acturer of the equipment or system as replacement parts
for internal components, may result in increased emission or
decreased immunity of the equipment or system.
Guidance and Manufacturer's Declaration- Electromagnetic Emissions
The MRIdian® system is intended for use in the
electromagnetic environment specified in the
following tables. The customer or the user of the MRIdian system should ensure that it is
used in such an environment.
IEC60601-1-2 Table 1 Guidance and Manufacturer’s Declaration—Electromagnetic Emissions
Emissions test Compliance Electromagnetic environment – guidance
Line Conducted Emissions
CISPR 11
Class A;
2.6dB below
the
limits
The MRIdian system must emit
electromagnetic energy in order to perform
its intended function. Nearby electronic
equipment may be affected.
Radiated RF Emissions
CISPR 11
Class
A;1.0dB
below the
limi
ts
The MRIdian system must be used only in a
shielded location with a minimum RF
shielding effectiveness. For each
cable that
exits the shielded location, a minimum filter
attenuation of 80dB from 10-20MHz, 100dB
from 20-80MHZ and 80dB from 80-100MHz
Harmonic Emissions
IEC 61000-3-2
N/A
Standard applies to equipment rated < 16
Amps,
for the MRIdian system this is the
treatment delivery and planning console
only.
Voltage Fluctuations and
Flicker
IEC 61000-3-3
N/A Standard applies to equipment rated < 16
Amps,
for the MRIdian system this is the
treatment delivery and planning console
only.
It is essential that the actual shielding effectiveness and filter attenuation be
verified at the location.