Indications For Use - Spinal Kinetics M6 Handhabungshinweise

EN
Description
Spinal Kinetics instruments and instrument cases are generally composed of
aluminum, stainless steel, and/or polymeric materials. The cases may be multi-layered
with various inserts to hold surgical instrumentation in place during handling and
storage. The inserts may consist of trays, holders, and silicone mats. The instrument
cases are perforated to allow steam to penetrate these various materials and components.
The instrument cases will allow sterilization of the contents to occur in a steam
autoclave utilizing a sterilization and drying cycle that has been validated by the user
for the equipment and procedures employed at the user facility. Instrument cases do
not provide a sterile barrier and must be used in conjunction with a sterilization
wrap to maintain sterility.
These instructions are provided in accordance with: AAMI TIR12, AAMI TIR30,
DIN EN ISO 17664, and ISO 17665-1.

Indications for Use

Manual surgical instruments are intended for use in a wide variety of surgical
procedures. The instruments are intended to scrape, cut, grasp, hold, remove, or
manipulate tissue or structures. The instrument cases include instrument trays,
which may be used to hold the instruments during steam sterilization cycles. It is the
responsibility of the surgical team to select the appropriate instrument for each case
and be familiar with Spinal Kinetics' surgical technique guidelines.
Contraindications:
None known
Materials
Aluminum
Stainless Steel
Polymeric Materials
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