META SMARTACT evo Manual Del Usuario página 7

INSTRUCTIONS FOR USE
EN
A1
(A) Pedal
(B) Connection cable
(C) Compressed air cable
(D) Lower adjustment ring nut
(E) Central handpiece body
Intended use
SMARTACT evo is a pneumatic system that allows positioning tacks to
fixate and stabilize the membrane in bone regeneration in oral surgery. It
can be used to stabilize both resorbable and non-resorbable membranes.
SMARTACT evo is equipped with a pneumatic pedal that allows imparting
a force (adjustable depending on the type of bone), which instantly inserts
the tack, thus fixating the membrane firmly to the bone. The extremely
compact handpiece is designed with a tapered shape and curved tip so
that even the most inaccessible areas of the mouth can easily be reached.
SMARTACT evo is made of material free of hazardous substances and
resistant to corrosion.
• SMARTACT evo is supplied non-sterile. It must be washed
and disinfected and some components sterilized before each
use.
• The SMARTACT evo device must be used exclusively by skil-
led medical staff.
• The surgeon must assess whether the patient is suitable for
bone regeneration operations and the appropriate surgical
procedure.
• Never use SMARTACT evo without ensuring that all its com-
ponents have been assembled correctly (see assembly in-
structions).
• Assemble the handpiece first and then connect the instru-
ment to the pedal to prevent accidental activation. The me-
dical staff and the patient must wear protective goggles.
Carefully follow the assembly sequence (see assembly in-
structions).
• Never operate SMARTACT evo without having inserted the
single-use tack insertion device and the tack.
• Make sure that you correctly insert the single-use tack in-
sertion device and the single-use striker (see Photos 4 and
5) and do not detach the titanium tack from the pin holder
before positioning (Photo 19) to prevent the risk of accidental
ingestion by the patient.
• When the instrument is not in use, adjust it to minimum force
for safety.
• Do not leave the instrument connected to the compressed
air (even at minimum force) once you have completed the
operation.
• Before use, check that the instrument package is intact.
• Do not use the product if the package is damaged.
• Always wear sterile gloves when handling the SMARTACT
evo device and follow strict procedures in order to guarantee
sterility.
• After use, discard in special medical waste containers in
compliance with the regulations in force.
• Meta cannot be held responsible for improper use of the
product.
How to assemble the instrument before use
Strictly follow the assembly sequence; failed, partial or incorrect assembly of
a component may result in:
• failed or improper functioning;
• damage to the instrument.
The assembly sequence is shown in Scheme 1.
When you have assembled the instrument, it is recommended to cover the
cable and handpiece with appropriate single-use protective sheaths to facili-
tate subsequent washing and sterilization of the instrument.
How to assemble the SMARTACT evo Pin tacks on the instrument
Strictly follow the sequence to load the device. Failed, partial or incorrect
assembly of a component may result in:
• risk of accidental ingestion of the tack, tack insertion device or striker by
SMARTACT
evo
(F) Upper ring nut
(G) Inertial system
(H) Curved body
(I) Head ring nut
(J) Inertial system locking wrench
the patient;
• failed or improper functioning;
• damage to the instrument.
The assembly sequence is shown in Scheme 2.
It is strongly inadvisable to use tacks from other manufacturers. Meta cannot
be held responsible for this improper use of the instrument, which may put
the patient at risk and seriously damage the device.
How to adjust and use the instrument
After positioning the tack on the head of the handpiece as explained in Sche-
me 2, position the instrument (in line with the receiving plane) on the insertion
area and operate the pedal (fully depress the pedal and release it). If neces-
sary, depress the pedal again until the tack has completely been inserted.
Based on the clinical case and with reference to the bone density and crest
anatomy (thickness, slope, etc.), the surgeon should decide how many times
the pedal needs to be depressed.
The instrument is fitted with an adjustment ring nut that allows the user to
select the suitable insertion force by turning the ring nut from minimum to
maximum.
It is recommended to adjust to minimum for the lateral sinus floor areas.
It is recommended to adjust to intermediate for the upper jaw areas with
variable cortical bone thickness and bone density Type II or III.
It is recommended to adjust to maximum for the lower jaw areas with cortical
bone density type I.
Before adjusting SMARTACT evo, it is recommended to perforate the cortex
in order to test the bone consistency.
How to disassemble the instrument after use
After using the instrument, disassemble it following the assembly instructions
shown in Scheme 1 in reverse order. Thoroughly wash and clean the instru-
ment before putting it away.
How to wash and sterilize the instrument
The device is supplied non-sterile. The pedal, the cable and the handpiece
body (components A, B, C, D, E - see Photo A1) must be washed and disin-
fected before each use.
NB: always close the compressed air intake and disconnect the cable
from the connector before disassembling the instrument.
The components of the upper part of the handpiece: upper ring nut, curved
body, head ring nut, inertial system and locking wrench of the inertial system
(components F, G, H, I, J - see Photo A1) must be washed, decontaminated
and sterilized before each use.
Wash with appropriate germicidal detergents immediately after the surgical
procedure. Use suitable detergents; do not use hydrogen peroxide (H2O2)
or chlorine-based detergents.
The components that must be sterilized (F, G, H, I, J) after washing must be
placed in an appropriate bag for subsequent sterilization.
The components must be sterilized in a steam autoclave at 121°C for 30
minutes, always using validated sterilization cycles in compliance with the
regulations in force. Sterility is guaranteed if the bag is intact. Always check
the bag before use.
Maintenance
Routine maintenance consists of washing and cleaning the instrument ac-
cording to the above mentioned procedures.
Connecting the instrument to the compressed air
The instrument must be connected to the compressed air system.
If the pressure is:
- less than 4 bar: the operating force will be insufficient;
- more than 4 bar: the higher pressure will affect the operating speed of the
instrument; the force imparted on the tack is in any case independent of the
operating pressure.
The recommended operating pressure is between 4 and 6 bar.
SMARTACT
A2
(L) Single-use tack insertion
device
(M) Single-use striker
(N) Titanium tack with pin holder
and protective cap
evo
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