Safety Requirements Before And During Use - mectron Piezosurgery flex Gebrauchs- Und Wartungsanleitung

5.4 Safety Requirements Before and During Use
WARNING: Before starting the activity,
always assure having a set of spare parts
(handpiece, inserts, wrenches) to be used in
the event of a failure or problem.
WARNING: Only use original Mectron
accessories and spare parts.
WARNING: Use of non-original
Mectron inserts: this can completely
damage the threading of the handpiece,
affecting the proper operation and causing
injury to the patient.
CAUTION: Contraindications. Do not
perform treatments on prosthetic artifacts
made of metal or ceramics. The ultrasonic
vibrations could lead to the de-cementing of
the artifacts.
WARNING: Contraindications. Do not
use the PIEZOSURGERY® flex on patients
with heart stimulators (Pace-makers) or
other implantable electronic devices. This
precaution also applies to the operator.
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.
WARNING: Infections control. First
use: All new and repaired accessories are
supplied in NoN STERILE conditions. Before
use, and after each treatment, they must be
cleaned and sterilised in strict compliance
with the instructions given in the Cleaning
and Sterilization Manual. Subsequent uses:
After every treatment, clean and sterilize all
the reusable parts and accessories, following
the instructions provided in the Cleaning and
Sterilization Manual.
CAUTION: Contraindications. When the
reusable items (the handpiece, the torque
wrench, and any other accessory that can be
sterilized) have been autoclave sterilized, wait
for them to cool down to room temperature
prior to usage. The cooling process must not
be accelerated.
CAUTION: The electrical contacts
inside the cord connector must be dry.
Upon completion of the sterilization cycle,
before connecting the handpiece cord to the
device, make sure that the electrical contacts
are perfectly dry. If necessary, dry them with
compressed air.
WARNING: To ensure that the handpiece
cools down, do not operate it without the
irrigation circuit correctly installed and filled.
To fill the irrigation circuit, always use the
PUMP function.
WARNING: Always check delivery of
the irrigation before and during use. Make
sure the fluid comes out from the insert. Do
not operate the device if the water is not
delivered or if the pump is defective.
WARNING: Check the level of the
physiological solution inside the relative
saline bag. Replace the irrigation bag with a
new saline bag before it is empty.
WARNING: The PIEZoSURGERY®
Medical irrigation kit is guaranteed for one
treatment only. Remove and dispose of the
sterile line according to local regulations
related to the hospital waste.
WARNING: Before using
PIEZoSURGERY® Medical Irrigation Kit
inspect the sterile package and the product
for any damage. Do not use the irrigation
kit if package is opened or damaged.
Irrigation kit loses sterility in case of broken
or damaged packaging. In case of damaged
packaging, dispose of the irrigation kit. Do
not sterilized or re-use the kit.
USE
19