Materials And Implant Materials Used; Before Use; Intraoperative Procedure - KLS Martin group Reconstruction de l'avant-bras IPS Implants Mode D'emploi

4.1.2

Materials and Implant Materials Used

The patient-specific anatomical models are made of plastic.
The patient-specific drill and marking guides are made of refined polyamide.
The patient-specific implants are made from additively manufactured titanium (titanium alloy Ti6Al4V,
ASTM F136-02, (ELI grade 23)). The product can be adjusted using rotating instruments
(e.g. milling machine, diamond-coated tools).
Danger of injury from system failure due to excessive mechanical load!
The implant can lose its function if it is damaged due to re-bending. This can cause chips and fragments
and lead to injuries.
• Re-bending is therefore not permitted.
• Avoid excessive mechanical load.
4.2

Before Use

• Implants, drill and marking guides and anatomical models delivered in sterile condition must
be marked with the corresponding symbol on the label.
Before use, the packaging must be checked for the expiration date and absence of damage.
Implants with opened or damaged packaging or sterile products that have been taken out of packages with
passed expiration date must be considered non-sterile.
Sterile implants must be removed from the packaging just before use.
• Remove implants, drill and marking guides and anatomical models delivered in non-sterile condition
from their packaging and subject them to a suitable preparation procedure prior to application, see
section
5 "Processing", page 43.
4.3

Intraoperative Procedure

The intraoperative procedure is described below for the IPS® Implants Forearm Reconstruction (radius and
ulna) so as to cover both indications. The procedure must be adapted accordingly if only the radius or only
the ulna is to be treated.
Position the patient
Bring the patient in a supine position on the operating table. The forearm to be surgically treated is
positioned on the extension table in supination position and in upper-arm tourniquet ischemia.
38
Instructions for Use
IPS® Implants Forearm Reconstruction
Revision 1