FGM Arcsys 35.49.09 Instrucciones De Uso página 10

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INSTRUCTIONS FOR USE
FGM Sterilizable Polymer Cases
For professional use only
Prior to the utilization of the product, read carefully
the information contained in this manual. Save it for
consultation for as long as there is any interaction
of the product with the last patient. The selection,
planning and execution of the case must, irrevocably,
be carried out by a duly capable professional dentist,
who has mastered implantodontics techniques.
1. Product description
The FGM Sterilizable Polymer Cases serve as storage
for components and instruments of the Arcsys
Implant System (sold separately), in such a way that
they are held by the silicon support (autoclavable
silicone) or by its respective storage niche. When
instruments are needed in the practice, the case
allows for the correct identification of the components
and instruments, as well as their adequate storage.
Fig. 1 –Arcsys Surgical and Prosthetic Case (open).
Fig. 2 –Arcsys Prosthetic Case (open)
2. Commercial availability
FGM Sterilizable Polymer Cases are reusable,
supplied as non-sterile, therefore, they need to
be sterilized before utilization, according to the
instructions contained in this manual. They are sold
in a single carton box packaging in order to protect
the product during handling (primary packaging), and
labeled for identification.
The lower part (bottom) and the upper part (lid) have
orifices that allow for the correct sterilization of the
instruments inside.
CODE DESCRIPTION
35.49.09 Arcsys Prosthetic Case
35.49.08 Arcsys Surgical and Prosthetic Case
3. Basic composition
FGM Sterilizable Polymer Cases are manufactured in
autoclavable polymer.
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4. Recommendations
FGM Sterilizable Polymer Cases consist of boxes
manufactured in autoclavable polymer, recommended
for storing medical products (dental instruments) for
sterilization. The use of FGM Sterilizable Polymer
Cases allows for the correct sterilization of the
devices and rationalizes storing and organization of
instruments for when they are needed in surgeries
and during the prosthetic rehabilitation phases.
5. Precautions and contraindications.
The handing, planning and execution of the surgery
must be irrevocably carried out by a duly capable
professional dentist who has mastered implantology
techniques. The patient and the area to be implanted
must be carefully analyzed by means of: clinical exam,
blood tests, radiography and tomography according
to the criteria established by the dentist.
• For cleaning FGM Sterilizable Polymer Cases use
only products with a neutral pH (pH 7-8).
• Any product that may have its superficial
characteristics altered during transportation (falls
or other accidents), that has been handled wrongly
or undergone any tampering MUST NOT BE USED.
• No sharp or pointy objects should be placed near
the product not to damage its structure, keeping its
integrity.
• All products must be handled with care. The
inadequate handling may damage or change the
adequate operation of the product.
• Use this product ONLY for the purposes indicated
in this Instructions for Use. Any application other
than that specified in this document may damage
or change the adequate operation of the product.