Before Implantation / Before First Use; Intraoperative Procedure - KLS Martin group L1 Rib Gebrauchsanweisung

L1 Rib
Instructions for Use
4.2

Before implantation / Before first use

The L1 rib plates and the L1 rib screws are delivered sterile. Products delivered in sterile condition are
marked with the corresponding symbol on the label. They must be removed from the packaging only
immediately before use. Before use, the packaging must be checked for the expiration data and for
absence of damage. Sterile products with opened or damaged packaging or sterile products that have been
taken out of packages with passed expiration date must be considered non-sterile. They must be discarded.
The majority of the L1 rib instruments are not delivered sterile. Products delivered in non-sterile condition
must be removed from their packaging and be subjected to a suitable preparation process before use.
4.3

Intraoperative procedure

Possible risk of injury to the patient due to improper handling!
Improper handling of the L1 rib plates and screws can result in implant failure and injuries.
Damage reduces the load-bearing capacity and may lead to breakage.
Possible risk of injury to the patient due to the processing of implants.
• Ensure that no material particles or chippings of the implant and/or the instruments enter the patient's
body during processing. Otherwise there is a risk of infection.
• Impurities (e.g. fragments) on the implant, instruments, the surgical periphery or the surgical team
caused by the machining process must be removed by suitable measures (e.g. by washing in sterile
water, changing the surgical gloves) before any contact with the patient.
• Sharp edges which occur as a result of processing must be rounded to avoid soft tissue irritation and/or
injuries.
• Should the implant and/or the instruments break during surgery, all fragments must be removed from
the situs. Otherwise, there is a risk of foreign body reactions or migration with resulting soft tissue
damage.
Revision 01 47