Electromagnetic Safety - Myray Hyperion Instrucciones De Uso

2.2.8. ELECTROMAGNETIC SAFETY

Do not use electronic devices that do not comply with IEC 60601-1-2: 2007 in proximity of life-support equipment
(e.g. pacemakers or heart stimulators) and hearing aids.
In healthcare facilities, before using any electronic device, always make sure that it is compatible with the other
devices present, including the X-ray device.
Guidance and manufacturer's declaration – Electromagnetic emissions
hyperion MRT / hyperion is suitable for use in the specified electromagnetic environment. The purchaser or user of
the hyperion MRT / hyperion should assure that it is used in an electromagnetic environment as described below:
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Guidance and manufacturer's declaration – Electromagnetic immunity
hyperion MRT / hyperion is suitable for use in the specified electromagnetic environment. The purchaser or user of
the hyperion MRT / hyperion should assure that it is used in an electromagnetic environment as described below:
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions
and voltage
variations on
power
supply input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic
field
IEC 61000-4-8
12
Compliance
Group 1
Class B
Class A
Complies
IEC 60601-1-2
Test level
6 kV contact
8 kV air
2 kV for power
supply lines
1 kV for input/output
lines > 3 m
1 kV differential mode
2 kV common mode
0% U for 0.5 cycles
n
40 % U for 5 cycles
n
70 % U for 25 cycles
n
0 % U for 5 s
n
3 A/m
OPERATOR'S MANUAL
Electromagnetic Environment
This hyperion MRT / hyperion uses RF energy only for
its internal function.
Therefore, the RF emission is very low and not likely
to cause any interference in nearby electronic
equipment.
This hyperion MRT / hyperion is suitable for use in all
establishments, including domestic establishments
and those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purpose.
Compliance
level
Floors should be wood, concrete or ceramic
IEC 60601-1-2 tile. If floors are covered with synthetic
Test level material, the relative humidity should be at
least 30%.
Mains power quality should be that of a
IEC 60601-1-2 typical commercial or hospital environment.
Test level
IEC 60601-1-2 Mains power quality should be that of a
Test level typical commercial or hospital environment.
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the hyperion MRT / hyperion
IEC 60601-1-2 requires continued operation during power
Test level mains interruptions, it is recommended that
the hyperion MRT / hyperion be powered
from an uninterruptible power supply or a
battery.
Power frequency magnetic fields should be
at levels characteristic of a typical location
IEC 60601-1-2
in a
Test level
environment.
Electromagnetic Environment
typical commercial or hospital
EN