Version history

This page records the controlled revision history of these instructions for use (IFU). In accordance with Section 23.4(y) of Annex I (General Safety and Performance Requirements) of Regulation (EU) 2017/745 (the MDR), it provides the date of issue of this IFU and, for any subsequent revision, the date of issue and the identifier of that revision.

Each entry corresponds to a single approved change to the IFU. Consistent with our Quality Management System (procedure GP-001), every revision is uniquely and tamper-evidently identified and retained within the manufacturer's controlled document system. The identifier of the latest revision is the Version shown in the most recent row of the table below, together with its date of issue. The Date column records the approval date, that is, the date on which the revision was approved under this document's defined approval chain. The Version column gives a sequential, human-readable label.

Because this IFU is a digital document, every change made anywhere in it is accompanied by a new entry in the table below, so this page always reflects the latest released version.

Version	Date	Summary of changes
1	2026-06-23	Initial release.