Enraf Nonius TENSMED S82 Instructions For Use Manual page 34

EMC ACCOMPANYING DOCUMENTS
Essential performance
PERFORMANCE
Electrostimulation.
Loading of the
programs from the
memory.
Battery charge.
In compliance with:
EN 60601-1: 2006 + A1: 2013
EN 60601-1-2: 2015
EN 60601-2-10: 2015
EN 60601-1-11: 2015
Warning: radiofrequency communication devices (including accessories like antennas or antenna
cables) must be used at least 3 meters away from every part (including cables and accessories)
of the electrostimulation device. Otherwise the performance of the electrostimulation device can
be affected.
1727751-51
CONDITION RISK
External Display information no
disturbance longer readable.
(Burst).
Lack of internal Interruption of the
power supply. treatment.
Lack of external Interruption of the
power supply. treatment.
Detachment of an Unpleasant
electrode. stimulation or painful
electric shock in case
of reconnection of the
electrode.
Setting of a Dangerous
current that is too stimulation.
high.
Error in the data Execution of an
from the memory. incorrect program.
Battery Damaging of the
overheating. device, display
information no longer
readable, explosion,
fire.
ACCEPTED EVENT
The machine must stop the stimulation.
The machine must maintain the
stimulation and accept the commands.
The machine must signal the battery
exhaustion and the interruption of the
treatment.
The machine must not work when
connected to the mains.
The machine must monitor the current
constantly on each active channel. In case
the detected current is below a certain
threshold, the machine must rest the
current of the channel.
The machine must always display with
the same scale the current level set. The
set level must stay on display.
The machine that does not detect the
contact of the electrode must reset the
current of the channel and indicate the
resetting on the display.
The machine must check the correctness
of the data of the programs. In case an
error is detected, the device must restart.
The user can try a new execution of the
program. If the error persists, the restart
will be done again avoiding the relaunch
of the program in which the errors are
detected.
The device must limit the battery
charging current to avoid overheating.
The device must be provided with fuses
at the connector input for the battery
charger and into the battery pack to
prevent dangerous current.
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