WARNING: Breakage and wear of the
inserts. The high-frequency vibrations and
general wear and tear can, very occasionally,
lead to insert breakage. Do not bend, change
the shape or sharpen an insert in any way.
Bending an insert or applying leverage to it
can cause it to break. Deformed or otherwise
damaged inserts are liable to break during
use. These inserts must never be used.
Excessive pressure on inserts during use can
cause them to break. If the tip of the insert
comes into contact with metal objects, it may
break leaving fragments in the operating
site. In the event of breakage, check that no
fragments remain in the treated part, and at
the same time suction effectively to remove
any of them. If a fragment cannot be found,
use diagnostic tools such as x-rays to confirm
that the broken piece is not in the surgical
area. During the intervention, regularly
check the insert integrity, in particular on the
apical part. During the intervention, avoid
prolonged contact with retractors or other
metal tools being used.
WARNING: The PIEZOSURGERY® plus
device is intended for bone surgery. However,
prolonged contact and/or excessive force of
the instrument tip on soft tissues should be
avoided as this may cause thermal and/or
blunt injury. Take particular care when sharp
inserts are used. Prolonged mechanical action
of a sharp insert may also result in the soft
tissue being cut. In close proximity to soft
tissues/nerves (e.g. the perinevrium of the
peripheral nerve system, or dura mater of
central nervesystem), it is recommended to
complete the cut with a blunt tip diamond
coated insert, to minimize the potential for
soft tissue damage.
30
WARNING: Before using the
PIEZOSURGERY® medical handpiece on the
patient, check that all parts of the device are
properly working.
CAUTION: Intermittent function.
Prolonged use can cause the handpiece to
overheat. Refer to
Chapter 7 on page 33
for average use times (intermittent function).
WARNING: Sterile single-use. Sterile
single-use objects must only be used in a
single surgical operation and for a patient,
only. Single-use objects must not be reused.
Separate and dispose of each single-use
object according to current regulations
governing hospital waste.
WARNING: During surgery, do not
perform any maintenance activity on the
system.
WARNING: The device is classified for
intermittent mode of operation (as reported
in
Chapter 7 on page 33
use of the device for a prolonged time and
in any case exceeding the declared time
limits can cause overheating, in particular, of
the handpiece. In case of overheating, avoid
contact of the handpiece with the operator
and the patient.
). The continuous