Scope Of Delivery; Inspection Of The Delivery For Completeness And Absence Of Damage - KLS Martin group IPS Implants marPOR Mode D'emploi

For case planning, the patient data and/or other case-related information is first uploaded to the IPS Gate®
by the qualified user. The IPS Gate® is a web-based platform that guides the user through the process for
patient-specific products in a structured manner.
The requirements, information and patient data provided by the qualified user in IPS Gate® are used by the
manufacturer for the individual case planning. A case number is assigned (example C1234567), and the
case is thus unmistakably linked to an individual patient.
Once the planning has been completed, the user is given access to the case-specific product documentation
(approval document) via IPS Gate®. If this meets his/her requirements, the user must approve the patient-
specific implant for production by submitting the signed document "Written Prescription and Design
Approval".
Possible risk of injury of the patient in case of outdated or incorrect patient data!
Patient-specific implants are produced using imaging procedures, e.g. CT images of the patient. If the
patient's anatomical situation has changed since the creation of the images, the patient-specific implants
must not be used.
2.3

Scope of delivery

The scope of delivery consists of
• one pre-made patient-specific implant or, in some cases, multiple pre-made patient-specific implants,
• the corresponding anatomical model.
If desired by the user and coordinated in advance via IPS Gate® as part of the individual case planning, the
scope of the delivery may also optionally include patient-specific, custom-made planning aids. Planning aids
and anatomical models are supplied with separate Instructions for Use. They are therefore not subject of
this document.
Each delivery is accompanied by a delivery note, which contains the case number that was assigned
uniquely during case planning via IPS Gate
2.4

Inspection of the Delivery for Completeness and Absence of Damage

• Immediately upon receipt, the goods must be checked for completeness and absence of damage.
• Reconcile the delivery with the existing case-specific product documentation from case planning, and
check for correct fit. This is ideally done based on the case number. If the case number does not match
the case-specific documentation, there has been a mix-up, and the product must not be used.
• Any transport damage as well as deviations in the case number indicated in the delivery note / on the
product packaging of the case-specific product documentation must be reported immediately.
20
IPS Implants® marPOR - patient-specific polyethylene implants
® .
Instructions for Use
Revision 01