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The Iradimed Corporation's MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system when placed as close as clinically possible to the MR system, without being placed within the magnet's bore, up to a 15,000 Gauss magnetic field line. The pump and infusion sets are designed to deliver saline and IV medication. The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in primary, loading, bolus, or KVO delivery mode. The dedicated Iradimed 1056, 1058, and 1059 Infusion Sets for the MRidium 3870 MRI Infusion Pump are intended for single patient use up to 6 hours. The device is intended for Adult and Pediatric patients, including Neonates. Careful clinical considerations involving drug and dosing should always be applied especially with regard to neonatal subpopulations (i.e., low and extremely low birth weight). This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.

The MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion Pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system allowing placement as close as physically possible to the MRI scanner without being placed within the magnet's bore, up to a 15,000 Gauss magnetic field line. The magnetic content of the Pump is such that there is no hazard of magnetic attraction, up to 3T (30,000 gauss). The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (non-magnetic) motor. The integral infusion set mounting channel is horizontally oriented in the front of the pump with position detection sensors and graphical user feedback to aid the user in the correct infusion set loading process. The main assembly of the pump unit contains the controls, display, power supply, battery, and processor/memory functions suitable to meet all system requirements. A remote display (3875) is also available as an option for independent viewing and control from the adjacent MRI Control Room area (Zone III). The Dose Rate Calculator feature allows the user to set up a patient's infusion rate based upon user selected parameters, including volume to be infused, dose, concentration, weight, and/or time. The Dose Rate Calculator feature also provides a Drug Library, allowing the user to program a patient's infusion protocol from selected parameters, including volume to be infused, dose, concentration, weight and/or time with soft and hard limits for each drug. These Drug Library inputs can only be created or modified by the Iradimed in-house clinical team based on input and validation from the healthcare facility. Once programmed, the library is digitally signed requiring proper verification by a software 'key' within the 3870 MR IV pump upon loading. Loading of the drug library requires access to the Password protected Service Menu. The Dose Error Reduction System (DERS) feature allows user-facilities to provide input to custom names, and doses, with hard and soft limits for use in the Drug Library. The Drug Library supports care area specific infusion protocols for primary, bolus, loading dose, and KVO delivery modes, retrievable by drug/protocol name. The library, as prescribed by the healthcare facility, is programmed with nominal starting values for: Dose, Concentration, and Time. Also, hard limits (maximum and minimum allowable) and soft limits (high and low limits that require a user confirmation to exceed) for Dose, Concentration, Time and Patient Weight can be programmed.

The IRadimed Corporation's 3880 MRI Patient Monitoring System is intended to monitor a single patient's vital signs for patients undergoing Magnetic Resonance Imaging (MRI) procedures. The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals. The 3880 MRI Patient Monitoring System is intended for use in Adult and Pediatric, including Neonatal populations, for monitoring of Electrocardiogram (ECG), Pulse Oximetry (SpO2), Non-Invasive Blood Pressure (NIBP), Temperature, Anesthetic Agents, Respiration, Capnography (CO2), and Oxygen (O2).

The 3880 MRI Patient Monitoring System, also referred to as the 3880, cleared October 25th, 2017, is a multi-parameter vital signs monitor designed for use in the Magnetic Resonance (MR) environment by trained healthcare professionals. The 3880 processes and displays multiple parameters, waveforms, measurement numeric values and alarms. The device is powered by either AC line power or its internal battery. It is light weight making it a practical intra-department patient transportation monitor for use within the MRI suite. The device can be carried by its handle, mounted to a wheeled cart/stand, or attached to a patient bed. The 3880 provides monitoring for the following parameters: - Electrocardiogram (ECG) ● - Heart rate (HR- ECG, SpO2, and NIBP derived) ● - Blood oxygen saturation/pulse oximetry (SpO2) ● - Non-invasive blood pressure (NIBP) - End-tidal and fractional inspired CO2 (EtCO2 and FiCO2) ● - Anesthetic agents (AGENTS) (requires 3886 Multi-Gas Unit) ● - Desflurane (DES) O - Enflurane (ENF) O - Halothane (HAL) O - Isoflurane (ISO) O - Sevoflurane (SEV) O - Fractional inspired O2 (FiO2), and end-tidal and fractional inspired N2O (EtN2O and FiN2O) ● (requires 3886 Multi-Gas Unit) - Temperature (TEMP) ● - Respiration rate (CO2-derived) ●

The IRadimed Corporation's 3880 MRI Patient Monitoring System is intended to monitor a single patient's vital signs for patients undergoing Magnetic Resonance Imaging (MRI) procedures. The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals. The 3880 MRI Patient Monitoring System is intended for use in Adult and Pediatic, including Neonatal populations, for monitoring of Electrocardiogram (ECG), Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) and Temperature. The 3880 MRI Patient Monitoring System is also intended for use in Adult and Pediatric, not including Neonatal populations, for monitoring of Pulse Oximetry (SpO2), Anesthetic Agents, Respiration, Capnography (CO2) and Oxygen (O2). The 3880 MRI Patient Monitoring System provides monitoring for three distinct patient types as defined below (Note: Pediatric group excludes Neonates): 1 - Adult (greater than 22 years). 2 - Pediatric (Infant 29 days - 2 years), Child (2 - 12 years), Adolescent (12 - 21 years), 3 - Neonate (28 days).

The 3880 MRI Patient Monitoring System, also referred to as the 3880, is a multi-parameter vital signs monitor designed for use in the Magnetic Resonance Imaging (MRI) environment by trained healthcare professionals. The 3880 processes and displays multiple parameters, waveforms, measurement numeric values and alarms. The device is powered by either AC line power or its internal battery. It is light weight making it a practical intra-department patient transportation monitor for use within the MRI suite. The device can be carried by its handle, mounted to a wheeled cart/stand, or attached to a patient bed. The 3880 provides monitoring for the following parameters: Electrocardiogram (ECG), Heart rate (HR- ECG, SpO2, IBP and NIBP derived), Blood oxygen saturation/pulse oximetry (SpO2), Non-invasive blood pressure (NIBP), Invasive blood pressure (IBP), End-tidal and fractional inspired CO2 (EtCO2 and FiCO2), Anesthetic agents (AGENTS) (requires 3886 Multi-Gas Unit) - Desflurane (DES), Enflurane (ENF), Halothane (HAL), Isoflurane (ISO), Sevoflurane (SEV), Fractional inspired O2 (FiO2), and end-tidal and fractional inspired N2O (EtN2O and FiNzO) . (requires 3886 Multi-Gas Unit), Temperature (TEMP), Respiration rate (CO2-derived).

The IRadimed Corporation's 3880 MRI Patient Monitoring System is intended to monitor a single patient's vital signs for patients undergoing Magnetic Resonance Imaging (MRI) procedures. The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals. The 3880 MRI Patient Monitoring System is intended for use in Adult and Pediatric, including Neonations, for monitoring of Electrocardiogram (ECG). Non-Invasive Blood Pressure (NIBP), and Temperature. The 3880 MRI Patient Monitoring System is also intended for use in Adult and Pediatric. not including Neonatal populations, for monitoring of Pulse Oximetry (SpO2), Anesthetic Agents, Respiration, Capnography (CO2), and Oxygen (02). The 3880 MRI Patient Monitoring System provides monitoring for three distinct patient types as defined below (Note: Pediatric group excludes Neonates): | Patient Type | Age | |--------------|----------------------------------------------------------------| | 1 Adult | greater than 22 years | | 2 Pediatric | (Includes: Infant, Child and Adolescent) | | -Adolescent | aged 12 through 21 (up to but not including the 22nd birthday) | | -Child | 2 years to less than 12 years | | -Infant | 29 days to less than 2 years | | 3 Neonate | from birth through the first 28 days of life |

The 3880 MRI Patient Monitoring System, also referred to as the 3880, is a multi-parameter vital signs monitor designed for use in the Magnetic Resonance (MR) environment by trained healthcare professionals. The 3880 processes and displays multiple parameters, waveforms, measurement numeric values and alarms. The device is powered by either AC line power or its internal battery. It is light weight making it a practical intra-department patient transportation monitor for use within the MRI suite. The device can be carried by its handle, mounted to a wheeled cart/stand, or patient bed. The 3880 provides monitoring for the following parameters: - Electrocardiogram (ECG) - Heart rate (HR- ECG, SpO2, and NIBP derived) - Blood oxygen saturation/pulse oximetry (SpO2) - Non-invasive blood pressure (NIBP) - End-tidal and fractional inspired CO2 (EtCO2 and FiCO2) - Anesthetic agents (AGENT) (requires 3886 Multi-Gas Unit) - Desflurane (DES) - Enflurane (ENF) - Halothane (HAL) - Isoflurane (ISO) - Sevoflurane (SEV) - Fractional inspired O2 (FiO2), and end-tidal and fractional inspired N2O (EtN2O and FiN2O) (requires 3886 Multi-Gas Unit) - Temperature (TEMP) - Respiration rate (CO2-derived) The 3880 MRI Patient Monitoring System can be ordered with the following configurations: Standard Configuration: | | 3880 MRI Patient Monitor | | | | | |---------------|--------------------------|------|------|-----|------| | Configuration | ECG | SpO2 | NIBP | CO2 | Temp | | 3880 | X | X | X | X | X | Optional Configuration (Requires 3880 and 3886): | | 3886 Multi-Gas Unit | | | |---------------|---------------------|-----|----| | Configuration | AGENTS | CO2 | O2 | | 3886 | X | X | X | The 3880 consists of the following key components: - Patient monitor with buttons and touch screen display - Wireless ECG POD, "ePOD" - Wireless SpO2 POD, "oPOD" - Battery for patient monitor - Power supply and cables - Operation Manual Accessories to the 3880 are offered to accommodate various patient sizes. Key standard and optional accessories include: - ECG cables and electrodes - SpO2 sensors and grips - NIBP cuffs and hoses - Temperature sensor - Cannulas - Remote monitoring tablet (3885-T) - Remote monitoring tablet docking base, including printer (3885-B) - Multi-Gas Unit (3886) - Mounting hardware and stand

The Iradimed Corporation's MRidium 3860+ MRI Infusion Pump/Monitoring System is intended for: - General hospital or clinical use by medical professionals whenever it is required to infuse patients with subcutaneous, intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile position. - The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in either continuous, intermittent, or bolus delivery mode. - The Infusion Pump can be used inside the MRI room mounted outside the 10,000 Gauss line (1 Tesla line), and with shielded magnets of field strength of 3.0 Tesla or less. - This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications. - The Pulse Oximeter is used to measure, display, and record functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing of the Oximeter was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot checking and/or continuous monitoring of patients who are well or poorly perfused in the MRI. The infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100 mmHg as the high negative pressures can result in uncontrolled fluid flow.

The MRidium 3860+ MRI Infusion Pump/Monitoring System with software version 3.5.3 is an MRI compatible IV pump intended for use within the MR Scan room. The device operates to full specification in magnetic fields of up to 10,000 Gauss and has RF emissions at Larmor frequencies up to and including 3.0 Tesla MR scanners (132 MHz) such that image signal to noise is not visibly affected with the pump within 1 foot from the MRI bore opening. The magnetic content of the device is such that there is no hazard of magnetic attraction. The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (nonmagnetic) motor. This integral channel is vertically oriented to the right side of the main assembly of the pump unit shall contain the controls, display, power supply, battery, processor/memory functions suitable to meet the complete and expanded system requirements. The left side of the unit is designed to accommodate attachment of an optional second peristaltic pump channel (Model 3861) which is controlled through the main pump assembly's display and controls. A remote display (Model 3865) is also available for independent viewing and control from the adjacent MRI Control areas. The Dose Rate Calculator feature, allows the user to set up a patient's infusion rate based upon user selected parameters, including volume to be infused, dose, concentration, weight, and/or time. The Dose Rate Calculator feature also provides a Drug Library, allowing the user to program a patient's infusion protocol from selected parameters, including volume to be infused, dose, concentration, weight and/or time. The Drug Library includes a small drug library consisting of 5 drugs (four common medications most frequently infused during MRI procedures, and one customizable drug) and with the DERS library card, can hold up to 50 customizable drugs. The optional DERS library card also includes the ability of setting hard and soft limits for each drug. This Drug Library feature can only be activated/de-activated with a service-related, limited user access menu. The Dose Error Reduction System (DERS) option (P/N 1145) to the Dose Rate Calculator feature allowing user facilities to program custom drug names, doses, and limits for use in the Dose Rate Calculator. A user programmable drug library memory card stores the specific infusion protocols established by the hospital facility. This library is accessed using the pump's Dose Rate Calculator Menu. The drug library card supports a number of separate user-programmed infusion protocols for either primary and/or primary/bolus infusions, retrievable by drug/protocol name. The library can be programmed with nominal starting values for: Dose, Concentration, and Time. Also, hard limits (maximum and minimum) and soft limits (high and low limits that require a user confirmation to exceed) for: Dose, Concentration, Time and Patient Weight can be programmed. Programming the custom medications and limits is performed with the pump and a dedicated drug library SD Memory Card in the limited access service mode. The Pulse Oximeter feature of the 3860+ MRI Infusion Pump/Monitoring System is used in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. It is indicated for continuous monitoring of patients in the MRI who are well or poorly perfused. The 3860+ System displays the patient's pulse rate and SpO2 values, as well as applicable alarm limits. The 3860+ System includes adjustable and visual pulse rate and oxygen saturation (SpO2) alarms. It also includes a variety of additional features, including low battery alarms, status indicators and sensor-related alarms. The 3860+ System only uses fiberoptic SpO2 sensors. These fiber optic sensors, cables, and associated finger wrap accessories contain no conductive components; they can be applied safely to the patient while inside an MR (magnetic resonance) environment. The 3860 model number is used for the same infusion device with no SpO2 module.

The Iradimed Corporation's MRidium 3860 MRI Infusion Pump/Monitoring System is intended for: - General hospital or clinical use by medical professionals whenever it is required to infuse patients with subcutaneous, intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile position. - The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in either continuous, intermittent, or bolus delivery mode. - The Infusion Pump can be used inside the MRI room mounted outside the 10,000 Gauss line (1 Tesla line), and with shielded magnets of field strength of 3.0 Tesla or less. - This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications. - The Pulse Oximeter is used to measure, display, and record functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing of the oximeter was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot checking and/or continuous monitoring of patients who are well or poorly perfused in the MRI. The infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100 mmHz as the high negative pressures can result in uncontrolled fluid flow.

The MRidium 3860 MRI Infusion Pump/Monitoring System is an MRI compatible IV pump intended for use within the MR Scan room. The device shall operate to full specification in magnetic fields of up to 10,000 gauss and have RF emissions at the Larmor frequencies up to and including 3.0 Tesla MR scanners such that image signal to noise is not visibly affected with the pump within 1 foot from the MRI bore opening. The magnetic content of the device is minimal so as to avoid any hazard of magnetic attraction. The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (non-magnetic) motor. This integral channel is vertically oriented to the right side of the unit. The main assembly of the pump unit shall contain the controls, display, power supply, battery, and processor/memory functions suitable to meet the complete and expanded system requirements. The left side of the unit is designed to accommodate attachment of an optional second peristalitic pump channel which is controlled through the main pump assembly's display and controls. A remote display is also available for independent viewing and control from the adjacent MRI Control areas. The Dose Rate Calculator feature, allows the user to set a patient's infusion rate based upon a user selected parameters, including volume to be infused, dose, concentration, weight, and/or time. Additionally, the Dose Rate Calculator feature with the Drug Library option, allows the user to choose a patient's infusion protocol using user selected parameters, including volume to be infused, dose, concentration, weight, and/or time. The Drug Library includes common medications most frequently infused during MRI procedures. This Drug Library option feature can only be activated with a service-related, limited user access menu. The Pulse Oximeter feature of the 3860 MRI Infusion Pump/Monitoring System is used in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing was performed in MR conditional environments at 1.5T and 3T. It is indicated for continuous monitoring of patients in the MRI who are well or poorly perfused. The 3860 System displays the patient's pulse rate and SpO2 values, as well as applicable alarm limits. The 3860 System includes adjustable audible and visual pulse rate and oxygen saturation (SpO2) alarms. It also includes a variety of additional features, including low battery alarms, status indicators and sensor-related alarms. The 3860 System only uses fiberoptic SpO2 sensors. These fiber optic sensors, cables, and associated finger wrap accessories contain no conductive components, they can safely be placed on the patient's finger while inside an MR (magnetic resonance) environment.

The Iradimed Corporation's MRIDIUM 3850 Infusion Pump System is intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile position. The specific MRidium 3850 Series MRI Infusion Pump System (including the MRidium 1000 Series of Infusion Sets) indications for use are as follows: 1. Useful in the administration of fluids requiring precisely controlled infusions and including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids. 2. Useful in the following delivery routes: arterial, intravenous, spinal, subcutaneous, and enteral. 3. Useful in the following delivery modes: continuous, intermittent and bolus. 4. Although specifically intended for use in the MRI, this product can be useful in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the pump can be monitored or supervised by a clinician. 5. Used inside the MRI room mounted outside the 10,000 Gauss line and with MRI magnets of field strength of 3.0 Tesla or less. The MRidium 1000 Series Infusion Sets are intended as accessories to the MRidium 3850 Series MRI Infusion Pump for use in the administration of fluids for precisely controlled infusion rates. The infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -250 mmHg and could result in uncontrolled fluid flow.

The MRidium 3850 MRI Infusion Pump System is an MRI compatible IV pump intended for use within the MR Scan room. The device shall operate to full specification in magnetic fields of up to the 10.000 gauss-line of a 3.0 Tesla MR Scanner, and have RF emissions at the Larmor frequencies up to and including 3.0 Tesla MR scanners such that image signal to noise is not visibly affected with the pump within 1 foot from the MRI bore opening. The magnetic content of the device is minimal so as to avoid any hazard of magnetic attraction. The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (non-magnetic) motor. This integral channel is vertically oriented to the right side of the unit. The main assembly of the pump unit shall contain the controls, display, power supply, battery, and processor/memory functions suitable to meet the complete and expanded system requirements. The left side of the unit is designed to accommodate attachment of an optional second peristaltic pump channel which is controlled through the main pump assembly's display and controls. The MRidium 1000 Series Infusion Sets utilize medical-grade PVC tubing with a medical-grade silicone rubber pumping segment that fits into a custom housing within the Pump. These Infusion Sets also contain the necessary flow stop/prevention devices, needle-free access ports, and fluid bottle/bag insertion devices required for safe and effective fluid delivery.