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The SpaceStation MRI is a MRI (Magnetic Resonance Imaging) System Rack for the operation of Space Infusion Pumps during MRI examinations (MRI procedures) of adult, pediatric or neonatal patients. The product is intended to be used by qualified healthcare professionals. The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic infusion syringe pump and pump accessories. The system is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, irrigation'ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood components, Total Parenteral Nutrition (TPN), Lipids, and enteral fluids. The Perfusor® Syringe Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances). The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, dedicated administration sets, and pump accessories. The system is intended for use on adults, pediativs, and neonates for the intermittent or continuous delivery of parenteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, irrigation/ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to colloids and cristalloids, blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments. (only road ambulances).

The SpaceStation MRI is a movable MRI Rack System for the operation of up to four B.Braun Space Infusions Pumps in MRI rooms (faraday cage of antimagnetic materials) during MRI examinations of patients. The SpaceStation MRI does not include the Infusion Pumps, and it does not control the operation of the user-installed Infusion Pumps. Patients are moved from nursing units to the MRI area with infusing pumps which are placed in the SpaceStation MRI for the MRI scan. The SpaceStation MRI is a RF-shielded housing which is mounted on the trolley. The mechanical construction of the housing makes it possible to position the system within the MRI room; it provides a shielded space and mechanical and electrical connections for up to four Space Infusion Pumps. A window in the door allows for direct viewing of the inserted infusion pumps, allowing all pump status and alarm conditions to be observed. The exterior housing provides IV line inlets and outlets, and knobs to release the infusion pumps. The SpaceStation MRI (Unit) includes the SpaceStation with SpaceCover comfort and Magnet Indicator Tesla Spy 2010. The SpaceCover comfort includes a large light display that shows the status and alarm condition of the pumps within the station as well as an audible alarm. The Magnet Indicator Tesla Spy 2010 allows the operator to correctly position the SpaceStation MRI within the MRI room by measurement of the magnetic flux density. An optical and audible alarm is triggered if the station is too close to the MRI, exceeding the permitted flux density. The Trolley has an IV pole and provides a mount for the Safety Tether. The SpaceStation MRI is not connected to a network. The Perfusor® Space Infusion Syringe Pump is a 12V DC or battery powered external, transportable, infusion syringe pump. The Perfusor® Space Infusion Syringe Pump utilizes a swivel-drive pumping mechanism and is intended to provide infusions of parenteral fluids. The Perfusor® Space Infusion Syringe Pump is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances). A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting. The system is intended to provide intermittent or continuous delivery of parenteral fluids to the patient. Parenteral fluids may include all standard fluids and/or medicated for infusion as well as blood and blood products. The Perfusor® Space Infusion Syringe Pump uses standard, single-use, disposable syringes (with luer-lock connectors) designed for use on syringe pumps and validated on the Perfusor® Space Infusion Syringe Pump. The Infusomat Space Volumetric Infusion Pump is a 12V DC or battery powered external, transportable, volumetric infusion pump. The Infusomat Space Volumetric Infusion Pump utilizes a linear peristaltic pumping mechanism and is intended to provide infusions of parenteral fluids. The Infusomat Space Volumetric Infusion Pump is intended for but not limited to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances). A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting. The system created by using the administration sets with the Infusomat Space Volumetric Infusion Pump is intended to provide intermittent or continuous flow of parenteral fluids to the patient. Parenteral fluids may include all standard fluids and/or medications indicated for infusion as well as blood and blood products.