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510(k) Data Aggregation

    K Number
    K972535
    Device Name
    MAGLIFE C
    Manufacturer
    ODAM
    Date Cleared
    1998-01-13

    (189 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    ODAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maglife C is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO2), nitrous oxide concentration (%N Q), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO2) in the immediate vicinity of a Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations.
    Device Description
    MAGLIFE C is a multi-parameter patient monitor which has been designed for use in the immediate vicinity of a Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations. The parameters that can be monitored are electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO2), nitrous oxide concentration (%N D), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO). The monitor consists of a line-powered console (with optional back-up battery) which is placed outside the magnet bore, and appropriate electrodes, transducers, cables and tubes to allow the patient to be monitored during the examination. The console enclosure is a Faraday cage for the protection of sensitive electronic circuits.
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    K Number
    K950264
    Device Name
    MAGLIFE
    Manufacturer
    ODAM
    Date Cleared
    1996-09-27

    (613 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    ODAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MAGLIFE® is a device for monitoring the vital signs of patients who are undergoing a Magnetic Resonance Imaging examination. This device is designed for this special environment where ordinary patient monitoring equipment cannot be used for the following reasons : - * The magnetic and electric fields present in the vicinity of the MRI can interfere with the proper operation of ordinary monitors. - ★ The presence of ferromagnetic materials in an ordinary monitor may influence the homogeneity of the magnetic field and thereby degrade the quality of the image acquired. - * Some magnetic materials can become dangerous projectiles in the presence of large magnetic fields. The indications for use are identical to the indications for vital signs monitoring of patients not undergoing MRI examinations.
    Device Description
    The MAGLIFE® MRI-Compatible Vital Signs Monitor is a complete patient monitoring system designed to be installed inside the Faraday Cage. It monitors ECG, arterial blood oxygen saturation, pulse rate, expired end tidal CO2 (etCO2), N2O concentration (%N2O), minimum inspired CO2, respiration rate, noninvasive blood pressure, and invasive blood pressure. The system consists of three enclosures ; a power supply which is permanently anchored to the floor, an operator console which includes a display and control keypad, and a connection box which is placed near the magnet opening and accepts the patient connections. Output of information includes real-time display of waveforms, digital display of calculated parameters, and audible and visual alarm indicators. Accessories include nonmagnetic patient connections for all parameters. Safety of the operator and patient is ensured by compliance to IEC 601-1.
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