Electromagnetic Safety - Myray hyperion X5 Manual De Operador

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.
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
RF emissions
CISPR 11
RF emissions
CISPR 11
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
Electrostatic
discharge (ESD)
IEC 61000-4-2
IEC 61000-4-4
fast/burst electric
transients
Overvoltage
IEC 61000-4-5
Voltage drops,
short interruptions
and voltage
change on the IEC
61000-4-11 input
electric line
Magnetic field at
network frequency
(50/60 Hz)
IEC 61000-4-8
16
Guidance and manufacturer's declaration - Electromagnetic emissions
Conformity
Group 1
Class A
Guidance and manufacturer's declaration - Electromagnetic immunity
IEC 60601-1-2
Test level
6 kV contact
8 kV air
2 kV for electrical lines
1 kV for input/output
lines > 3 m
1 kV differential
mode
2 kV standard 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
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.
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.
Conformity
degree
Floors must be made of wood, concrete or
IEC 60601-1-2 ceramic tiles. If floors are covered with
Test level synthetic material, the relative humidity
should be at least 30%.
The power supply line quality should be that
IEC 60601-1-2
of a
Test level
environment.
The power supply line quality should be that
IEC 60601-1-2
of a
Test level
environment.
The power supply line quality should be that
of a
environment. If the hyperion X5 user
IEC 60601-1-2
requires a continuous operation also in
Test level
case of blackout, it is recommended to
power the hyperion X5 with uninterruptible
power supply or batteries.
The magnetic fields at network frequency
IEC 60601-1-2 should feature levels typical of a standard
Test level commercial or hospital environment.
Electromagnetic Environment
typical commercial or
typical commercial or
typical commercial or
hospital
hospital
hospital
EN