Installation; Safety Requirements In The Installation Phase - mectron Piezosurgery flex Gebrauchs- Und Wartungsanleitung

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INSTALLATION

To guarantee proper device functionality, it
must be installed by an authorised Mectron
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;
4.1 Safety Requirements in the Installation Phase
WARNING: Contraindications.
Interference with other equipment. The
PIEZOSURGERY® flex device complies with
the standard IEC 60601-1-2. However, it may
interfere with other devices in its vicinity.
Install PIEZOSURGERY® flex at safety distance
from life-support systems. If adjacent or
stacked use of the device is necessary,
normal operation of the equipment and
PIEZOSURGERY® flex, in the configuration
in which they will be used, should be verified
prior their use.
WARNING: Contraindications.
Interference by other equipment. An
electrosurgical knife of other electrosurgical
units placed in the vicinity of the
PIEZOSURGERY® flex device may interfere
with its correct functioning.
WARNING: Risk of explosion. The
device cannot operate in environments where
the atmosphere is saturated with flammable
gases (anesthetic mixtures, oxigen, etc.).
CAUTION: The electrical system of the
relevant operating room, where the device
is installed and used, must comply with the
applicable regulations and with electrical
safety requirements.
CAUTION: To avoid risk of electric shock,
this device must be grounded.
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 Mectron the completed forms to
guarantee traceability of the device and
the activation of the warranty.
WARNING: Do not operate the foot
pedal of the PIEZOSURGERY® flex when the
peristaltic pump lid is open. Moving parts
could injure the operator.
WARNING: Install the device in a place
protected against impacts or accidental
splashes of water or other liquids.
WARNING: Do not install the device
on top of or close to sources of heat. When
installing, make sure that adequate air
circulates around the device. Leave sufficient
room around it, with particular reference to
the fan on the rear.
CAUTION: Do not expose the device to
direct sunlight or sources of UV light.
CAUTION: The device is transportable
but must be handled with care when moved.
Position the footswitch on the floor in such a
way that it can only be activated intentionally
by the operator.
CAUTION: Before connecting the
handpiece cord to the device, make sure that
the electrical contacts are perfectly dry. If
necessary, dry them with compressed air.
CAUTION: Do not allow the device
console and the foot pedal to get wet. If
liquid enters the console or footswitch,
damage could occur.
CAUTION: No modification of this
equipment is allowed.
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