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 / dentist, 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 or procedures different than those
specified in the intended use of the
product;
2.
The environmental conditions for the
preservation and storage of the device
are not compliant to the precautions
indicated in the Chapter 8 on page
28;
3.
The device is not used in compliance
with all the instructions and precautions
described in this manual;
4.
The electrical system in the premises
in which the device is used is not
compliant to the norms in force and to
the relative precautions;
).
5.
The assembly operations, extensions,
adjustments, updates, and repairs on
the device are performed by personnel
not authorized by Mectron;
6.
Improper use, mistreatments, and/or
incorrect interventions;
7.
Any and all attempts to tamper with
or modify the device, under any
circumstance;
8. Use of non-original Mectron inserts that
entail a finite damage to the threading
of the handpiece, thus compromising
correct operation and causing risk of
harm to the patient:
9. Use of non-original Mectron inserts,
used in accordance to designed and
tested settings of Mectron original
inserts. The correct use of the settings is
guaranteed only with original 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.
INTRODUCTION
3