Imaging Bulk
Package (IBP)
and Contrast
Management
in the CT Suite

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

INDICATIONS:

The EmpowerCTA^®+ Injector System is indicated for the vascular administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner and an optional calculator for glomerular filtration rate (GFR).

The Extravasation Detection Accessory (EDA^™) is an optional accessory and is indicated for the detection of extravasations of ionic and nonionic contrast during CT procedures using a power injector.

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

CONTRAINDICATIONS:

The EmpowerCTA^®+ Injector System is not intended for use as a long-term infusion pump, nor is it intended to be used to inject any agents other than contrast or flushing media. Do not attempt to use the injector for any other purpose (such as chemotherapy or drug infusion). The EmpowerCTA⁺ Injector System should not be used to inject substances into nonvascular body cavities. Any applications of the EmpowerCTA⁺ Injector System other than those described in its Operator Manual are inappropriate and should not be attempted.

Not all products are available in all global markets.

EmpowerCTA⁺ is distributed by Bracco Diagnostics Inc.; 259 Prospect Plains Road, Bldg. H; Monroe Township, NJ 08831 USA; Phone: (800) 631-5245; Fax: (609) 514-2424; Customer Service: 1-877-BRACCO 9 (1-877-272-2269); Professional Services: 1-800-257-5181 (Option 2); EmpowerCTA⁺ Email: empowerinfo@diag.bracco.com; Website: https://smartinject.com/ct-solutions/

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

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.; 259 Prospect Plains Road, Bldg. H; Monroe Township, NJ 08831 USA; Phone: (800) 631-5245; Fax: (609) 514-2424; Customer Service: 1-877-BRACCO 9 (1-877-272-2269); Professional Services: 1-800-257-5181 (Option 2); Website: https://smartinject.com/mr-solutions/

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

NEXO^® Contrast Management System

Intended Use:

The NEXO^® Contrast Management System is a server-based application intended to be used as a data management and visualization system. The NEXO Contrast Management System can read, store, share, compare/relate, as well as graphically display data and injection programs coming from RIS, PACS, and multiple enabled EmpowerCTA^® Injector Systems. This device provides users with record lists, graphics, and reports about data and performances.

This device is intended for retrospective and statistical data management and visualization. It is not intended for real-time data visualization, diagnostic applications, or for any other use for which the device is not indicated. This device is only to be operated by and under quasi-continuous supervision of qualified and trained staff in an appropriately licensed healthcare facility.

The NEXO Contrast Management System is compatible with the EmpowerCTA Injector System version 8.0, and EmpowerCTA^®+ Injector System version 10.0 and higher.

Not all products are available in all global markets.

NEXO is distributed by Bracco Diagnostics Inc.; 259 Prospect Plains Road, Building H; Monroe Township, NJ 08831 USA; Phone: (800) 631-5245; Fax: (609) 514-2424; NEXO Customer Service: 1-877-BRACCO 9 (1-877-272-2269); NEXO questions: Nexo.Answers@diag.bracco.com; NEXO U.S. Technical Service and Support: Phone: 888-670-7701; Fax: 609-514-2448; NEXO Email: customer.support@acistmedical.com; Website: https://smartinject.com/digital-solutions

NEXO is manufactured by ACIST Medical Systems, 7905 Full Road, Eden Prairie, MN 55344 USA.

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, NEXO, and IRiSMR are registered trademarks of Bracco Injeneering S.A., registered in the U.S.

FastLoad is a trademark of Bracco Injeneering S.A.

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

INDICATIONS AND USAGE | IMPORTANT SAFETY INFORMATION

PRODUCT NAME® 

IMPORTANT SAFETY INFORMATION
WARNING: Lorem ipsum dolor sit amet, consectetur adipiscing elit. 

Praesent mattis eget nunc elementum malesuada. In et nunc lobortis massa maximus ullamcorper nec quis ante. Integer et dolor turpis. Vivamus id semper odio. Integer venenatis viverra elit vel interdum. Nam lectus diam, dictum non erat at, rutrum faucibus tellus. Proin in nulla sagittis, mollis eros eu, iaculis tortor. Nulla non sem scelerisque, congue ante vitae, venenatis urna. Phasellus et viverra leo. Nunc at ultricies felis. Nulla suscipit pulvinar euismod. Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas. Nunc eu erat tincidunt, lacinia arcu eu, maximus lectus.

• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult and pediatric patients with suboptimal echocardiograms
• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS CARDIOPULMONARY REACTIONS

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres. Most serious reactions occur within 30 minutes of administration.

• Assess all patients for the presence of any condition that precludes administration
• Always have resuscitation equipment and trained personnel readily available

Contraindications

LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use is contraindicated in patients with known or suspected hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG).

Warnings

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or shortly following administration of ultrasound contrast agents, including LUMASON. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to LUMASON administration and monitor all patients for acute reactions.

Post-marketing hypersensitivity reactions, including serious hypersensitivity reactions, have been observed during use or shortly following LUMASON administration. These reactions may occur in patients with no history of prior exposure to sulfur hexafluoride lipid-containing microspheres. LUMASON contains PEG. There may be increased risk of serious reactions including death in patients with prior hypersensitivity reaction(s) to PEG.

Systemic embolization may occur in patients with cardiac shunts. Assess patients with cardiac shunts for embolic phenomena following LUMASON administration.

There is a risk of ventricular arrhythmia related to high mechanical index in patients administered LUMASON. LUMASON is not recommended for use at mechanical indices greater than 0.8.

The most common adverse reactions (incidence ≥ 0.5%) are headache (1%) and nausea (0.5%).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information for LUMASON ultrasound contrast agent, including BOXED WARNING on Serious Cardiopulmonary Reactions.

LUMASON is manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831 by Bracco Suisse S.A., Plan-les-Ouates Geneve, Switzerland (LUMASON lyophilized powder vial-25 mg lipid-type A/60.7 sulfur hexafluoride gas); Vetter Pharma-Fertigung GmbH & Co. KG, 88212 Ravensburg, Germany (Sodium Chloride 0.9% Injection, USP); B. Braun Melsungen AG, 34212 Melsungen, Germany (Mini-Spike).

LUMASON and SONOVUE are registered trademarks of Bracco Diagnostics Inc. and its affiliated entities.

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