ulricheasyINJECT Max 3^™ (the Bracco-branded Max 3^™, a Rapid Exchange and Syringeless MR Injector System) is distributed by Bracco Diagnostics Inc.

Indications for use

ulricheasyINJECT Max 3 (XD 10180) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.

ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of the following contrast media:

• Gadobutrol Injection in single-dose (SD) container or Imaging Bulk Package (IBP)
• Gadopiclenol Injection in SD container or IBP
• Gadobenate dimeglumine Injection in SD container
• Gadoterate meglumine Injection in SD container

Easy-Click-Cassette – flex Max 3 is used for a maximum time of twenty-four (24) hours or a maximum of 96 bottles of contrast media, whichever comes first.

Use time expiration per SD container is a maximum of four (4) hours, unless otherwise stated by the contrast media labeling.

Use time expiration per IBP or saline container is a maximum of twenty-four (24) hours, unless otherwise stated by the media labeling.

Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.

ulricheasyINJECT Max 3 (XD 10180) is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.

The ulricheasyINJECT Max 3 (XD 10180) is not intended for injection of contrast media (CM) for high-pressure angiography.

Contraindications

The ulricheasyINJECT Max 3 injectors are not intended for the administration of contrast medium during high-pressure angiography or other applications that do not comply with the intended use.

The injector is not protected against the effects of defibrillation. Before a defibrillator is used, the patient must be disconnected from ulricheasyINJECT Max 3 injector.

Do not add any disposables (i.e. connector tubing or valves) to the ulricheasyINJECT Max 3 disposables or in conjunction with the patient tubing that are not provided by ulrich medical.

No valves or other connectors may be placed in-line between the patient tubing and the patient cannula. The disposables identified in this IFU are designed, manufactured, and tested for connection with cannulas for pressure injections.

Do not use ulricheasyINJECT Max 3 injectors with any other contrast media (other than those described in this IFU). Any other contrast media are inappropriate and should not be used.

Do not operate the injector and terminal, including any accessories, in potentially explosive atmospheres or in the vicinity of combustible materials (especially anesthetic drugs, detergents, and oxygen-enriched environments).

ulricheasyINJECT Max 3 is manufactured by ulrich GmbH & Co. KG.

ulrich medical is a registered trademark of ulrich GmbH & Co. KG.

ulricheasyINJECT Max 3 is a trademark of ulrich GmbH & Co. KG.

ulricheasyINJECT Max 3 is distributed as the Bracco-branded Max 3, a Rapid Exchange and Syringeless MR Injector System, by Bracco Diagnostics Inc.; 510 Carnegie Center, Suite 300, Princeton, NJ 08540 USA; Phone: (800) 631-5245; Fax: (609) 514-2424; Customer Service: 1-877-BRACCO 9 (1-877-272-2269); Scientific Information: 1-800-257-5181 (Option 2); Website: https://braccomr.com/max3/

All other trademarks and registered trademarks are the property of their respective owners.

EmpowerMR^® Injector System

Caution: Federal law restricts this device to sale by or on the order of a physician.

INDICATIONS:

The EmpowerMR^® Injector System is indicated for vascular administration of contrast media and flushing media in conjunction with magnetic resonance imaging (MRI).

Protocols have been independently developed and are not intended as medical advice, and Bracco shall not be responsible for any physicians’ reliance on these or any other protocols.

Bracco Injeneering S.A. reserves the right at any time and without notice, to change the specifications and features described herein, or to change the production or adjust the product described.

Not all products are available in all global markets.

EmpowerMR is distributed by Bracco Diagnostics Inc.; 510 Carnegie Center, Suite 300; Princeton, NJ 08540 USA; Phone: (800) 631-5245; Fax: (609) 514-2424; Customer Service: 1-877-BRACCO 9 (1-877-272-2269); Scientific Information: 1-800-257-5181 (Option 2); Website: https://braccomr.com/empowermr/

EmpowerMR is manufactured for Bracco Injeneering S.A., Avenue de Sevelin 46 CH – 1004 Lausanne, Switzerland. https://www.bracco.com/

About Bracco Injeneering S.A.

Bracco Injeneering S.A., located in Lausanne, Switzerland, is the most recently added Business Unit of Bracco Imaging. Bracco Injeneering is committed to developing the best-in-class, integrated injection solutions with a strong heritage in research and innovation. It provides quality solutions for state-of-the-art radiology centers, offering proven injection technology, built on Bracco Imaging’s expertise.

Thanks to this strengthened product portfolio, including the EmpowerCTA^®+ Injector System and EmpowerMR Injector System Bracco Imaging will be able to focus on constant innovation, not only for devices but also for software development and data management.

EmpowerCTA, EmpowerMR, and IRiSMR are registered trademarks of ACIST Medical Systems, Inc.

FastLoad is a trademark of ACIST Medical Systems, Inc.

All other trademarks and registered trademarks are the property of their respective owners.