Globus PREMIUM 400 - EMC ACCOMPANYING DOCUMENTS; Electromagnetic Compatibility and Risks

PREMIUM 400
REV 4_26.4.22
52
EMC accompanying documents
Essential performance
PERFORMANCE
CONDITION
RISK
ACCEPTED EVENT
Electrostimulation.
External disturbance
(Burst).
Display information no
longer readable.
The machine must stop the stimulation.
The machine must maintain the
stimulation and accept the commands.
Lack of internal
power supply.
Interruption of the
treatment.
The machine must signal the battery
exhaustion and the interruption of the
treatment.
Lack of external
power supply.
Interruption of the
treatment.
The device, if equipped with a battery,
must continue the treatment signaling
that operation is carry out in battery
mode.
Detachment of an
electrode.
Unpleasant stimulation
or painful electric
shock in case
of
reconnection of the
electrode.
The device must constantly monitor the
current on each active channel set over
9 mA. In case the detected current is
below a certain threshold, the machine
must rest the current of the channel.
The cable for
microcurrents is not
detected.
Dangerous stimulation.
The device must report an error relating
to the electrodes and prevent the
program from starting.
Setting of a current
that is too high in
case of
microcurrents.
Dangerous stimulation.
The device must derate the voltage
boost stage to prevent emitting a
current beyond the maximum value.
The device must not start the
microcurrent treatment if it does not
detect the hardware derating of the
voltage booster stage.
Loading of the
programs from the
memory.
Error in the data
from the memory.
Execution of an
incorrect program.
The machine must check the
correctness of the data of the
programs. In case an error is detected,
the device must restart.
Change of settings.
Setting data memory
error.
Operation error.
The device must check the correctness
of the settings data and in case of
errors it must load the default settings
present in copy in the memory and must
indicate on the display that the reset
has been carried out.
Display information no
longer readable.
The device must check the contrast
value. If it is out of range, the device
must reset the value to the default one.
Battery charge.
Battery overheating.
Damaging of the
device, display
information no longer
readable, explosion,
fire.
The device must monitor the
temperature of the battery, if a certain
threshold is exceeded, the battery
charging must be interrupted.