IRadimed out of Winter Park, Florida has won FDA 510K clearance for the firm’s MRidium 3860+ MRI Infusion System that features Masimo‘s SET SpO2 monitoring technology.
Clinicians no longer have to remember each time when they get to the door of the MRI to remove their standard hospital SpO2 equipment so that it does not become a dangerous projectile, or risk a patient burn, in the MR environment. IRadimed has innovatively combined two critically needed technologies for the MRI to increase productivity, patient safety, and ease of transport to, from, and within, the MRI.
The Innovative MRidium 3860+ MRI Infusion System is the first Non Magnetic IV Pump designed specifically for use in the MRI Environment with Integrated Masimo SET technology.
The MRidium Pump has the ability to work at the 10,000 Gauss magnetic field environment of 1.5 and 3.0 Tesla MR Scanners, and the system includes the remote control ability for adjusting critical medication deliveries and alarm monitoring from outside the MR Scanner room. The safe placement of the pump is of the utmost importance, because these safety-critical Gauss line limits are invisible and different for every magnet design and strength, which makes it difficult to know where the safe limits are in relation to the MR Scanner. The 10,000 Gauss Line is virtually inside the bore of the MR Scanner in many cases, which allows the use of the MRidium Pump in close proximity to the MR scanner.
The MRidium System’s remote ability allows clinicians to monitor the infusion progress and make changes to the pump from outside the MR scanner room without having to stop the scan; this provides the ability to adjust or bolus critical medications, such as Propofol, which is commonly used for MR Anesthesia, without interrupting, or unnecessarily delaying, the MR scan.
The New MRidium 3860+ System has a number of key new features which make this MR IV Pump simple and safe to deliver even the smallest of infusions. With rate ranges from 0.1 ml to 1400 ml per hour, the MRidium System is designed to meet all of your infusion needs. Our new 10 digit keypad makes programming a snap, with quick changes at the press of a few buttons. This Smart Infusion System also has an integrated programmable drug library designed for the MRI – making it an indispensible tool for delivery of critical medications such as Dobutamine, Adenosine, Propofol, and Dexmedetomidine. The system also offers a modular second channel which allows for delivery of two medications simultaneously during patient scans. A range of available infusion sets provides the necessary clinical flexibility needed for MRI Infusion. The MRidium 1055 Bypass Infusion set allows clinicians to quickly change over IV sets from the hospital based infusion system without having to disconnect the lines from the patient. The MRidium 1057 Vented Syringe Adapter Set allows for accurate delivery from a syringe using a low priming volume of only 4 milliliters per set.
Press release: IRadimed announces 510K Clearance of the New Non Magnetic MRidium MRI IV Pump with Integrated Masimo SET SpO2 Monitoring …
Product page: Pump 3860+ …
Product brochure (.pdf)…
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