These medical devices are intended for use by medical imaging and diagnostic healthcare professionals. For complete information about precautions and optimal usage conditions for these medical devices, we recommend consulting the instructions notices/user’s manuals.
Ensure that injection from multi‐dose containers and to more than one patient respects the valid rules of good practice and the marketing authorization (MA) of the contrast agent and local regulatory requirements. The multiple use of manyfill® disposables is intended for multi‐patient markets. Use a new secufill® patient line for each patient.
OptiVantage® injector is a medical device (Class: II b, CE0123) intended for use by medical imaging and diagnostic health professionals, for injecting radiopaque contrast media and saline into a patient’s vascular system during CT examinations.
OptiBolus® is a bolus shaping software that provides uniform contrast enhancement and extends image acquisition window for dynamic scanning procedures.
OptiVantage® disposables are medical devices (Class: II a, CE0123). Notified Body: TUV SUD Product Service GmbH. Manufacturer: Liebel-Flarsheim Company LLC, 2111 East Galbraith Road, Cincinnati, OH 45237, USA
Secufill®: single use patient line with double valve for CT & MRI (Class II a medical devices, CE0459).
Manyfill®: multi-use filling/injection set for CT (Class II a medical devices, CE0459).
Contrast&Care®: medical device (Class I, CE).
Notified Body: LNE G-Med. Manufacturer: Medex, 240 Allée Jacques Monod, 69800 Saint-Priest, France
OptiVantage®, OptiBolus®, Patency Check®, Timing Bolus®, OptiProtectTM, LF™, Contrast&Care®, secufill®, manyfill® are trademarks of Guerbet. Patents pending and issued patents. © Copyright 2018 Guerbet – All rights reserved.
Document modification date: February 2021 P21000425