Indications For Use; Users; Disclaimer - Mectron Piezosurgery plus Mode D'emploi Et D'entretien

All models of "Piezosurgery" bone surgery devices are intended for professional use only.
Therefore, the user is the only person able to decide if and how to treat their patients.
1.2.3 Indications for Use
The use of the device is suitable for all the appropriate patients (see chapter above) for whom a
bone surgery treatment is prescribed, by the treating physician, within the intended use of the
device (see Chapter 1.1 on page 1
1.2.4

Users

The device must be used only by specialised and properly trained personnel, such as a surgeon
physician, able-bodied adults of any weight, age, height, gender and nationality.
1.3

Disclaimer

The manufacturer, Mectron, refuses all specific or implicit liability and shall not be held liable for
any direct or indirect injury to people and/or damage to objects occurring following incorrect
procedures connected with the use of the device and its accessories.
The manufacturer, Mectron, cannot be held specifically or implicitly liable for any type of injury
to people and/or damages to objects caused by the user of the product and its accessories and
which took place in the following cases:
1. Use in procedures other than those
specified in the product's intended use;
2. The environmental conditions in which
the device is kept and stored do not
comply with the requirements indicated
in the Chapter 7 on page 33
3. The device is not used in accordance
with the instructions and requirements
described in this manual;
4. The wiring systems in the room where
the device is used do not comply with
the applicable standards and relevant
requirements;
5. Device assembly, extension, regulation,
update or repair has been carried
out by personnel not authorised by
Mectron; all assistance services must be
provided by qualified personnel only;
CAUTION: The back-up battery must be
replaced with a CR2032 type identical battery,
by authorised Mectron technical service
centres.
).
6. Improper use, damage and/or incorrect
interventions;
7. All attempted tampering or changes to
the device in any circumstances;
8. Use of non-original Mectron inserts,
;
which definitively damages the
handpiece thread, affecting correct
function and risking injury to the
patient;
9. Use of non-original Mectron inserts,
used according to the settings designed
and tested on original Mectron
inserts. Correct use of settings is only
guaranteed with original Mectron
inserts;
10. Lack of spare materials (handpiece,
inserts, wrenches) to be used in the
event of failure or problem.
INTRODUCTION
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