About This Document; Safety; Validity Of This Document; Abbreviations And Terms - KLS Martin group IPS Implants marPOR Mode D'emploi

1 About this document

1.1

Safety

Possible risk to life of the patient or user in case of non-observance of this document!
Improper handling and care as well as use other than intended can lead to premature wear and/or pose
a risk for patients and users!
It is the operator's responsibility to ensure that all personnel handling the product have understood and
do observe the notes and instructions in this document.
• Every user is required to read this document completely and follow it carefully.
• In particular, every user must observe all cautionary and warning notices.
• Keep this document accessible to users at all times.
• The user must ensure that the patient has been informed about and has understood the usage,
cautionary and warning notices provided in this document.
• This text refers to male, female and non-binary individuals equally,
1.2

Validity of this document

This document applies to:
• IPS Implants® marPOR – patient-specific polyethylene implants
1.3

Abbreviations and Terms

Abbreviation
EtO
PE
TMJ
UHMWPE

2 General

Thank you for choosing a KLS Martin IPS Implants® product.
The product described in these Instructions for Use was specifically manufactured in accordance with
a written prescription for an identified patient known by name and is intended solely to suit the patient's
individual condition and needs. This product is therefore a custom-made product within the meaning of the
applicable European regulations for the development, manufacture, placing on the market and monitoring
of medical devices and as such does not bear any CE marking. As a custom-made product, it nevertheless
18
Description
Ethylene oxide
Polyethylene
Temporomandibular joint
Ultra-High Molecular Weight Polyethylene
IPS Implants® marPOR - patient-specific polyethylene implants
Instructions for Use
Revision 01