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SURGICAL
I NSTRUMENTS
The
instruments
sets
realized
by
Gruppo
Bioimpianti
are
designed
and
manufactured
to
provide
surgeons
with
the
necessary
instruments
to
realize
a
simple
and
safe
implantation.
Such
instruments
are
supplied
either
as
part
of
an
operating
set
in
dedicated
trays
or
individually,
and
are
identified
by
a
code
and
a
lot
number,
reported
on
the
label
when
present
and
on
the
device
if
possible.
Surgical
instruments
must
be
kept
in
hygiene-‐controlled
premises,
if
possible
in
dedicated
conservation
units
(surgical
instrument
trays).
The
materials
used
for
manufacturing
are
biocompatible
and
guarantee
good
resistance
to
corrosion
if
stored
in
appropriate
conditions.
It
should
be
remembered
that
organic
fluids
can
cause
local
corrosion,
so
it
is
good
practice
to
clean
instruments
after
use,
removing
traces
of
blood
or
other
organic
fluids
which
might
prove
aggressive
to
the
material
if
left
in
such
conditions.
The
instruments,
whether
part
of
an
operating
set
or
supplied
individually,
are
supplied
non
sterile.
Gruppo
Bioimpianti
S.r.l.
performs
on
each
instrument
a
washing
cycle
according
to
the
applicable
Operative
Instructions.
Gruppo
Bioimpianti
underlines
that
it
is
responsibility
of
the
hospital
facility
to
perform
on
each
instrument,
before
each
surgery,
the
following
sequence
of
processes,
that
must
be
performed
appropriately
according
to
the
internal
procedures
approved
by
each
facility:
decontamination,
washing
(manual
or
ultrasound),
re-‐
washing,
drying,
control
of
absence
of
residual
dirt
or
other
impurities,
control
of
lumen/holes,
control
of
the
integrity
of
the
instruments,
and
sterilization
according
to
a
sterilization
process
conforming
to
the
relevant
standards
(EN
556,
ISO
11137-‐1,-‐2,-‐3
and
ISO
11135-‐1
and
UNI
EN
ISO
17665-‐1).
Gruppo
Bioimpianti
S.r.l.
manufactures
instruments
that
can
be
sterilized
several
times,
even
using
the
simple
systems
g enerally
f ound
i n
h ospitals
( steam
s terilizers).
S hould
t he
i nstrument
b e
i mpaired
o r
s how
s igns
o f
superficial
alteration,
it
should
not
be
used.
Any
fracture
or
breaking
of
instruments
shall
be
reported
to
the
company.
The
use
of
components
and/or
instruments
not
included
in
the
instruments
set
provided
by
Gruppo
Bioimpianti
S.r.l.,
except
the
generic
instruments
present
in
the
operating
rooms
(drill,
oscillating
blades..)
could
determine
negative
events.
The
instruments,
if
not
carefully
operated
during
the
surgery,
could
cause
damages
to
the
implants.
Surgical
instruments
are
inevitably
subject
to
wear
with
normal
use
and
if
they
have
experienced
excessive
force
are
susceptible
to
fracture.
Surgical
instruments
should
only
be
used
for
their
intended
purpose,
as
illustrated
in
the
surgical
technique
provided
by
Gruppo
Bioimpianti
S.r.l.
It
is
recommended
that
all
instruments
be
regularly
inspected
to
identify
any
possible
damage.
WARNING:
if
the
instruments
are
intended
to
be
connected
with
an
active
medical
device
(electrical
engine),
the
compatibility
between
two
elements
of
the
connection
must
be
verified.
Do
not
leave
in
the
surgical
site
any
trial
component,
packaging,
instrument
or
part
of
it.
Being
medical
devices,
the
instruments
must
be
strictly
used
by
medical
personnel,
which
must
be
sufficiently
familiar
with
their
use
before
p erforming
t he
s urgery.
PREOPERATIVE
P RECAUTIONS
In
general,
it
is
always
advisable
to
carry
out
a
thorough
pre-‐operative
analysis
to
determine
the
most
appropriate
system
and
the
right
size
compatible
with
the
patient's
clinical
conditions
(age,
physical
activity/work,
weight,
mental
illness,
osteoporosis,
vascular
pathologies).
The
surgeon
is
to
be
thoroughly
familiar
with
the
implants,
instruments
and
surgical
procedures
prior
to
performing
surgery.
Regarding
surgical
technique,
Gruppo
Bioimpianti
S.r.l.
provides
indications
on
the
use
of
its
products.
In
addition
to
product's
documentation,
Gruppo
Bioimpianti
is
willing
to
support
the
exchange
of
professional
opinions
between
d octors
w ho
h ave
a lready
u sed
s uch
d evices
a nd
t hose
i nteresting
o n
i ts
u sing
f or
t he
f irst
t ime.
It
is
important
to
realize
an
appropriate
patients
selection,
during
which
the
following
important
factors
should
b e
c onsidered:
1. The
p atient
m ust
h ave
r eached
f ull
s keletal
m aturity;
2. Need
t o
o btain
p ain
r elief
a nd
i mprove
f unction;
3. Ability
and
willingness
of
the
patient
to
follow
indications,
including
control
of
weight
and
adequate
a ctivity
l evel;
4. Patient's
w eight;
5. Activity
a nd
o ccupation
l evel;
6. State
o f
h ealth
o f
t he
p atient.
The
patient
is
to
be
made
aware
and
warned
of
general
surgical
risks
and
possible
adverse
effects.
The
patient
i s
t o
b e
a dvised
o f
t he
l imitations
o f
t he
r econstruction
a nd
t he
n eed
f or
p rotection
o f
t he
i mplants
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