mectron PIEZOSURGERY GP, Use And Maintenance Manual, Page: 11 / 48

3
INTRODUCTION
operation and causing risk of harm to
the patient:
9. Use of non-original Piezosurgery/
Mectron inserts, used in accordance
to designed and tested settings
of Piezosurgery/Mectron original
inserts. The correct use of the settings
is guaranteed only with original
Piezosurgery/Mectron inserts;
10. Lack of stock materials (handpiece,
inserts, wrenches) to be used in the
event of device stop due to fault or of
inconveniences.
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.).
CAUTION : In the case that the end user,
when operating in his or her own medical
study or clinic, must subject the electro-
medical equipment and systems to periodical
inspections in order to adhere to imposed
requirements, 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
‘Medical electrical equipment - Recurrent
test and test after repair of medical electrical
equipment’. The interval for periodic checks,
in the intended operating conditions and
described in this “Use and Maintenance”
manual, is one year.
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. In case you uncover operating
abnormalities, do not perform the treatment.
Contact Piezosurgery Inc. Customer Service if
the abnormalities concern the device.
CAUTION : The electrical system of the
premises in which the device is installed
and used must be compliant to the norms
in force and to the relative electrical safety
precautions.
CAUTION : Only connect the console to
hospital grade receptacles to ensure electrical
grounding reliability. This device must be
grounded.
WARNING : Do not operate the
footswitch of the PIEZOSURGERY® GP
device when the pump head of the peristaltic
pump is open. Moving parts could injure the
operator.
WARNING : Control of infections.
First Use The reusable accessories (brand
new or returned by service) and the single-
use accessories (diamond coated inserts) are
delivered in NON-STERILE conditions and
must be prepared prior to use by applying
the procedures described in the Cleaning and
Sterilization manual provided with the device.
Every use Once used, each reusable
accessory must be thoroughly reprocessed
prior to reuse, according to the procedures
described in the Cleaning and Sterilization
manual provided with the device.