Users Manual Part 1

Clinical User’s Guide
IBA | xvii|
Volume 1 - Treatment Session
Limitation and Exclusion of Scope
The scope of this Clinical User’s Guide is to describe the operations, features, and
functions of the Proteus PLUS.
The Proteus PLUS is capable of interfacing with certain third party products. Where
applicable or necessary, these interfaces are described in this Clinical User’s Guide.
IBA does not assume any responsibility for third party products nor third party
product documentation. This Clinical User’s Guide in no way aims to replace the
relevant documentation of the third party vendor. The third party vendors at all times
remain fully responsible for their product and product documentation.
Modification of the IBA System or IBA Accessories
Users are requested not to make any unauthorized modification to the IBA System
or IBA accessories. Unless approved in writing and in advance by IBA, any
modification to the IBA System or to IBA accessories by the user may cause the loss
of the regulatory approval and will void the warranty, and/or be classified as an
abnormal failure under the uptime commitment.
Integration or Use of Third Party Equipment or non-
IBA Accessories
Users are advised to integrate or use in conjunction with IBA medical devices only
authorized third-party equipment or non-IBA accessories that are qualified by IBA as
compatible with the IBA System (like proprietary software installation such as the
Oncology Information System (OIS)).
Users are further advised to analyse the collisions or other hazards induced by the
use of immobilization devices.
Restriction of Use of OIS
The IBA PTS interfaced with an Oncology Information System (OIS) shall only be
used in combination with an OIS that is appropriately certified for the country where
the Proton Therapy System is deployed.
Restriction of Use of TPS and Gating System
The IBA PTS interfaced with a Treatment Planning System (TPS) and a gating system
shall only be used in combination with a TPS and a gating system that are
appropriately certified for the country where the Proton Therapy System is deployed.