mectron PIEZOSURGERY plus, Руководство по эксплуатации и обслуживанию, Страница: 16 / 60

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4 INSTALLATION AND CONFIGURATION
To guarantee proper device functionality,
it must be installed by an authorised
Piezosurgery Inc. technician. The device must
be installed in a suitable and convenient place
for its use.
The technician will need to carry out the
following 6 steps:
1.
unpack the device;
2. Explain to the user what precautions
need to be taken to ensure correct
installation;
3. Explain to the user all the possible
device configurations;
4. Explain how to clean, sterilise and
maintain the system;
5. Fill in the installation and hospital
personnel training forms;
6. Send Piezosurgery Inc. the completed
forms to guarantee traceability of
the device and the activation of the
warranty.
4.1 Safety Requirements During Installation
WARNING : MR-UNSAFE
PIEZOSuRGERY® plus MuST NOT BE uSED in
a Magnetic Resonance (MR) environment.
WARNING : Contraindications.
Interference with other equipment.
Although PIEZOSURGERY® plus complies
with standard IEC 60601-1-2, it may interfere
with other equipment located nearby.
PIEZOSURGERY® plus must not be used
near, or stacked on other equipment. Install
PIEZOSURGERY® plus at a safe distance
from life-support equipment. If necessary,
however, prior their use, please check
and monitor that the device and all other
equipment function correctly in that layout.
WARNING : Contraindications.
Interference by other equipment. An
electrosurgical knife of other electrosurgical
devices near the PIEZOSURGERY® plus
device, may interfere with its correct
functioning.
WARNING : Risk of explosion. The
device cannot function in places where there
is an atmosphere saturated with flammable
gases (anaesthetic mixtures, oxygen, etc.).
CAUTION : The wiring systems in the
room in which the device is installed and
used must comply with applicable standards
and relevant electrical safety requirements.
CAUTION : To avoid risk of electric shock,
this device must only be connected to power
grids with protective earth.
CAUTION : Do not expose the device to
direct sunlight or sources of UV light.
WARNING : When the peristaltic
pump cover is open, the foot pedal of the
PIEZOSURGERY® plus must not be pressed.
Moving parts may injure the operator.
WARNING : Install the device in a place
where it will be protected from blows and
accidental sprays of water or other liquids.
WARNING : Do not install the device on,
or in the proximity of heat sources. Install it in
such a way as to ensure adequate circulation
of air around the device. Leave sufficient free
space around it, in particular with reference
to the fan on the back of the device.
CAUTION : The device can be transported,
however it must be handled with care when
moved. Position the foot pedal on the floor
in such a way that it can only be activated
intentionally by the operator.
CAUTION : Position the device in such
a way as to ensure that the plug is easily
accessible as this is considered a means for
disconnecting the power supply.