Healthcare Industry News:  ventilator 

Devices FDA

 News Release - August 19, 2008

Draeger Fabius MRI Receives FDA Clearance to Provide Advanced Anesthesia Technology in the MR Environment

TELFORD, Pa.--(HSMN NewsFeed)--Draeger Medical, Inc. announced today that the Draeger Fabius MRI anesthesia machine has received FDA clearance. The newest member to the family of Draeger anesthesia machines is designed specifically to meet the requirements for the Magnetic Resonance Imaging (MRI) environment.

The Fabius MRI is designed for use with 1.5T and 3.0T MRI systems. An integrated Teslameter provides an acoustic alarm if the Fabius MRI is positioned within a field strength greater than 40mTesla (400 Gauss).

The Fabius MRI employs the same user interface as Draeger’s Fabius GS, Fabius Tiro and Apollo machines, creating a uniform and consistent interface for the anesthesia provider wherever anesthesia is required. The size of the MRI system often requires the anesthesia provider to be outside the room or some distance away from the device during an examination. To accommodate this, additional optical alarm displays (LEDs) at the top of the system provide visual indication for all alarm conditions for the safety of the patient in this specialized environment.

The Fabius MRI also continues the same quality of care to which clinical personnel are accustomed - from the OR application to the MRI environment. The standard configuration includes the advanced ventilation modes (volume and pressure controlled, pressure support and SIMV) that are especially needed for the care of premature infants, newborns, and ICU patients and makes them available for use in this environment.

The high-speed piston ventilator provides controlled compliance compensation, even with the longer ventilation tubes often used in the MRI environment, providing for even the smallest infant.

Draeger also offers a range of MRI-compatible accessories, all tested and certified for use with the Fabius MRI machine.

“Draeger is now offering the same quality of anesthesia delivery in the MRI suite as it provides in the most demanding OR environment,” said Robert Clark, Director of Anesthesia Care for the US. “We now offer an ICU-quality ventilator in an MRI setting, as well as a broad platform of anesthesia machines that are appropriate for any acuity situation. We are pleased to be able to offer our customers and their patients the highest quality of care wherever they are receiving anesthesia.”

About Draeger

Draegerwerk AG & Co. KGaA is an international leader in the fields of medical and safety technology. Draeger products protect, support and save human life. Founded in 1889, in 2007 the Group achieved sales of 1,819.5 million Euro worldwide and an EBIT of 151.9 million Euro. Today, Draeger employs around 10,000 people in more than 70 subsidiaries worldwide and has representation in around 190 countries. The Draeger Medical subsidiary offers products, services and integrated system solutions which accompany the patient throughout the care process – Emergency Care, Perioperative Care, Critical Care or Perinatal Care and Home Mechanical Ventilation. For more information, visit www.draeger.com.



Source: Draeger Medical

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