META Smartact, Instructions For Use Manual

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Smartact
Smartact
EN
INSTRUCTIONS FOR USE
Intended use
Smartact is a pneumatic system enabling positioning of tacks to secure
and stabilise a membrane as part of bone regeneration in oral surgery. It
can be used to stabilise both resorbable and non-resorbable membranes.
The Smartact system includes a pneumatic pedal to apply a force (ad-
justable depending on the type of use and linked to the type of bone) to
insert the tacks instantly thus firmly securing the membrane 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 be
reached easily. Smartact is manufactured using corrosion-proof materials
free of toxic substances.
• Smartact is supplied non-sterile. The device must be washed
and sterilised before each use.
• The Smartact device must be used exclusively by skilled
medical staff.
• The surgeon must assess the suitability of patients for bone
regeneration and the appropriate surgical procedure.
• Do NOT use Smartact unless you are sure all components
have been assembled correctly (see assembly instructions).
• Assemble the handpiece first and then connect the device
to the footswitch to prevent accidental operation. Medical
staff and the patient must wear goggles to protect their eyes.
Carefully follow the assembly sequence (see assembly in-
structions).
• Always insert the disposable tack insertion device and the
tack before using Smartact.
• Make sure the disposable tack insertion device (see photos
17 and 18) is inserted correctly to prevent accidental swal-
lowing by the patient.
• Make sure the tack is secured correctly to the disposable
tack insertion device (see photos 19, 20 and 21) to prevent
accidental swallowing by the patient.
• For safety reasons adjust the device to the SOFT application
force setting when not in use.
• Before use, check the device package is intact.
• Do not use the product if the package is damaged.
• Always wear sterile gloves when handling the Smartact de-
vice and strictly follow appropriate procedures in order to
guarantee sterility.
• Discard after use in special medical waste containers in com-
pliance with the regulations in force.
• Meta does not shoulder any responsibility for improper use
of the product.
Assembling the device before use
Carefully follow the assembly sequence; missing, partial or incorrect assem-
bly of a component may result in:
• failed or poor operation;
• damage to the device.
The assembly sequence is shown in enclosure 1.
When you have assembled the device, it is recommended the cable and
handpiece are protected using a suitable disposable sleeve to facilitate sub-
sequent cleaning and sterilisation of the device.
Inserting Smartact Pin tacks on the device
Carefully follow the tack insertion sequence. Missing, partial or incorrect as-
sembly of a component may result in:
• accidental swallowing by the patient of the tack in the tack inser-
tion device;
• failed or poor operation;
• damage to the device.
The assembly sequence is shown in enclosure 2.
Use of tacks produced by other manufacturers is not recommended.
Meta shall not be held responsible for this improper use of the device which
may put the patient at risk and seriously damage the device.
Setup and use
Insert the tack in the disposable tack insertion device, as shown in enclosure
2, position the device so it is aligned with the receiving plane at the graft area
and operate the footswitch. If necessary operate the footswitch a second
time to apply the tack fully. On the basis of the clinical case and with refer-
ence to bone density and alveolar crest anatomy (thickness, slope, etc.), the
surgeon must decide the number of footswitch operations required.
The device allows the user to select the level of application force (soft - me-
dium – hard).
The SOFT setting is recommended for areas of the lateral sinus floor.
The MEDIUM setting is recommended for areas of the maxilla with variable
cortical bone thickness and type II or III bone density.
The HARD setting is recommended for areas of the mandible with type I
bone density.
It is recommended you perforate the cortical bone to assess bone consis-
tency before selecting the Smartact setting.
The path of the cable must be as straight as possible without any tight curves
to ensure good system operation.
Disassembling the device after use
When you have finished using the device, disassemble it by following the as-
sembly procedure described in enclosure 1 in reverse order. Carefully wash
and clean the device before storing it.
Cleaning and sterilising the device
The device is supplied non-sterile. The device must be disinfected, cleaned
and sterilised before each use. Disconnect the cable from the footswitch
(without removing the handpiece) making sure you do not fold it too much as
this may damage it. Clean using special germicidal detergents immediately
after the surgical procedure. Use suitable detergents. Do not use hydrogen
peroxide (H
2
O
2
) or chlorine-based detergents. Place it in a special bag for
the sterilisation process.
Warning! The footswitch can be washed using suitable germicidal detergents
but cannot be sterilised in an autoclave.
Sterilise the cable and handpiece in a steam autoclave at 121°C for 30
minutes. Always use validated sterilisation cycles in compliance with current
legislation. Sterility is guaranteed if the bag is intact. Always check the bag
before using the device.
Maintenance
Routine maintenance involves washing and cleaning the device correctly in
compliance with that stated above.
Connecting the device to the compressed air supply
The device must be connected to the compressed air supply with a pressure
value of 2 bar.
If the pressure is:
• less than 2 bar: insufficient operating force;
• more than 2 bar: higher pressure values affect footswitch operation
speed but not the force exerted on the handpiece spring.
The recommended operating pressure is between 2 and 6 bar.
Optional compressed air connection kit
The optional compressed air connection kit can be supplied on request at
the time of purchase.
See the sequence described in enclosure 3 for details of how to assemble
the components correctly. The kit contains quick-release components for
connection to the footswitch and a compressed air hose which the user must
connect to the compressed air supply using a special coupling in compliance
with the air outlet installed in the dental practice.
Smartact commercial warranty
The commercial warranty provided by Meta is a guarantee of good operation
against defects arising as a result of long-term use.
Smartact is guaranteed in compliance with current legislation for 12 months
from the date of sale specified on the invoice.
The warranty is declared null and void in the event of improper use of the
device. Improper use includes the following: repairs and maintenance per-
formed by persons not authorised by the manufacturer, faults or damage
caused by falls, breakages, lightning strikes or penetration of liquids, faults
or damage caused by mechanical, chemical or thermal effects and devices
fitted with components or accessories not authorised by the manufacturer.
Customers must report any faults or defects within two months of discovery
for the warranty to remain valid. If a product or component is changed, any