The products used in the operation must be documented in the patient file with the case-specific data, in
particular the case number. Clear traceability of the products used can only be ensured through
documentation.
4.4
After the surgical procedure
Possible risk of injury to the patient due to improper behavior by the patient!
Improper postoperative behavior of the patient can lead to implant failure or injuries of the patient. Note
the following:
• All physical activities that may adversely affect the patient-specific implant or connected bone
elements should be avoided during the healing period. This applies especially to the carrying of heavy
loads (danger of falling) and to sporting activities that may involve impacts or blows.
The surgeon must advise the patient on post-surgical procedure and carry out follow-up.
•
Danger of dislocation of the implant!
Perform long-term follow-up after orbital implantation.
•
Patient-specific implants are intended for single use. Explanted and/or contaminated patient-specific
implants must not be processed and reused. They must be disposed of after completion of the surgical
procedure.
5 Cleaning, disinfection, and sterilization
• Patient-specific implants are supplied in sterile condition (EO sterilization). The implants with the
marking "Sterile EO" can be used without additional pretreatment directly after removal from their
sterile packaging.
• Reprocessing is not possible, as the product properties would be impaired by this process.
• Resterilization of the implants is not allowed.
6 Storage and transport
• Protect the products from dust and dirt.
• Store the products in a dry place, protected from moisture.
• Protect the products from mechanical damage.
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IPS Implants® marPOR - patient-specific polyethylene implants
Instructions for Use
Revision 01