Safety Precautions - mectron Piezosurgery flex Gebrauchs- Und Wartungsanleitung

1.4 Safety Precautions
WARNING: Risk of explosion.
The device cannot operate in environments
where the atmosphere is saturated with
flammable gases (anaesthetic mixtures,
oxygen, etc.).
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.
CAUTION: In the case the hospital must
subject the electro-medical equipment
and systems to periodical inspections in
order to adhere to imposed requirements
in its own structure, the test procedures
that must be applied to electro-medical
equipment and systems to evaluate safety
must be performed in line with norm EN
62353 'Electro-medical devices - Periodical
inspections and tests to be performed after
repair interventions on electro-medical
devices'. The interval for periodic checks,
in the intended operating conditions and
described in this "Use and Maintenance"
manual, is one year.
4
flex
WARNING: Checking device status
before the treatment. Always check that
there is no water underneath the device.
Before every treatment, always check that
the device works perfectly and that the
accessories are efficient. If anything unusual
is noted during operation, do not perform
the treatment. If the problem concerns the
device, contact an Authorized Mectron
Service Center.
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.
WARNING: Do not operate the foot
pedal of the PIEZOSURGERY® flex when the
peristaltic pump cover is open. Moving parts
could injure the operator.
WARNING: Personal injury. Take care
to ensure that cables do not hinder the free
movement of personnel.
CAUTION: US Federal Law (of the United
States of America) restricts this device to sale
by or on the order of a physician.
WARNING: Prior to any use, system
components should be inspected for
damage. Do not use if damage is apparent.
WARNING: Do not activate the device if
the handpiece is faulty, damaged or broken.
Replace the handpiece immediately.
WARNING: only use original Mectron
accessories and spare parts.
CAUTION: No modification of this
equipment is allowed.
WARNING: Contraindications. Do
not use PIEZOSURGERY® flex on patients
with heart stimulators (Pace-makers) or
other implantable electronic devices. This
precaution also applies to the operator.