Myray 708G, Operator'S Manual

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OPERATOR'S MANUAL EN
1.8.6. ELECTROMAGNETIC SAFETY
Do not use electronic equipment not complying with IEC 60601-1-2:2007 in proximity to life support equipment (e.g.
pacemakers or heart stimulators) and hearing aids.
Before using any electronic device in health facilities, always check that it is compatible with the other equipment
present, including X-ray device.
Guidance and manufacturer's declaration - Electromagnetic emissions
hyperion X5 is designed to operate in the electromagnetic environment specified below. The customer or the user
of hyperion X5 must ensure its use in an electromagnetic environment with the following features:
Emission test Conformity Electromagnetic Environment
RF emissions
CISPR 11
Group 1
hyperion X5 device uses RF energy only for its internal
operation.
For this, the RF emissions are very low and do not
interfere with the electronic devices nearby.
RF emissions
CISPR 11
Class A
hyperion X5 device must be used only by adequately
trained personnel (dentists and paramedics). hyperion
X5 device may cause radio interferences or disturb the
operation of the nearby equipment. It may be
necessary to adopt countermeasures, such as re-
orienting or moving the hyperion X5 device or
shielding the installation site.
Guidance and manufacturer's declaration - Electromagnetic immunity
hyperion X5 is designed to operate in the electromagnetic environment specified below. The customer or the user
of hyperion X5 must ensure its use in an electromagnetic environment with the following features:
Immunity test
IEC 60601-1-2
Test level
Conformity
degree
Electromagnetic Environment
Electrostatic
discharge (ESD)
IEC 61000-4-2
6 kV contact
8 kV air
IEC 60601-1-2
Test level
Floors must be made of wood, concrete or
ceramic tiles. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
IEC 61000-4-4
fast/burst electric
transients
2 kV for electrical lines
1 kV for input/output
lines > 3 m
IEC 60601-1-2
Test level
The power supply line quality should be that
of a typical commercial or hospital
environment.
Overvoltage
IEC 61000-4-5
1 kV differential
mode
2 kV standard mode
IEC 60601-1-2
Test level
The power supply line quality should be that
of a typical commercial or hospital
environment.
Voltage drops,
short interruptions
and voltage
change on the IEC
61000-4-11 input
electric line
0% U
n
for 0.5 cycles
40 % U
n
for 5 cycles
70 % U
n
for 25 cycles
0 % U
n
for 5 s
IEC 60601-1-2
Test level
The power supply line quality should be that
of a typical commercial or hospital
environment. If the hyperion X5 user
requires a continuous operation also in
case of blackout, it is recommended to
power the hyperion X5 with uninterruptible
power supply or batteries.
Magnetic field at
network frequency
(50/60 Hz)
IEC 61000-4-8
3 A/m
IEC 60601-1-2
Test level
The magnetic fields at network frequency
should feature levels typical of a standard
commercial or hospital environment.