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510(k) Data Aggregation

    K Number
    K181894
    Device Name
    TOF-Cuff monitor
    Date Cleared
    2019-05-09

    (297 days)

    Product Code
    Regulation Number
    870.1130
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    Applicant Name (Manufacturer) :

    RGB Medical Devices SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TOF-CUFF monitor is a device intended to monitor neuromuscular transmission and non-invasive blood pressure of adult patients during surgery and issue alarms related with these physiological parameters. It is not a therapeutic device. The monitor should be used exclusively in health institutions by trained medical professionals. The monitor is suitable for use in the presence of electrosurgery. Monitor is not intended to be used in the home environment. The monitor should be used only with a single patient.
    Device Description
    The device consists of the TOF-Cuff monitor and the TOF-Cuff pressure cuff. The applied part of the device is the TOF-Cuff pressure cuff. TOF-CUFF monitors the neuromuscular transmission (NMT) using the patented TOF-Cuff® method. TOF-Cuff® is a new method of monitoring neuromuscular blockade that has several advantages over previous methods. It is based on a modified pressure cuff that incorporates stimulating electrodes. The evoked muscle response is evaluated through the changes in pressure of the cuff generated by the muscular reaction after the electrical stimulus. The modified pressure cuff is also used for NIBP (Non-invasive Blood Pressure) measurement. Thus it is possible to monitor both parameters with only one patient sensor. NMT can work either in manual or automatic modes. In manual mode the user starts a measurement by touching buttons of main menu. In automatic mode the measurement is performed at reqular intervals. The time interval between measurements is selectable by the user. In automatic mode the user can start a measurement at any time. The user can stop a NMT measurement at any moment by pressing the NMT Stop key. TOF-CUFF monitor offers the possibility to start an automatic procedure for Neuromuscular Blockade (NMB) monitoring during the complete surgical process. The Auto-Pilot Program is designed to facilitate the work of the anaesthesiologist and change pattern type and stimulation cycle according to the different blockade phases during surgery, but NMT monitoring requires adequate vigilance and supervision by the anaesthesiologist TOF-CUFF monitor provides systolic, diastolic and mean arterial pressure values, as well as the pulse rate, in a non-invasive way, by means of an enhanced version of the oscillometric method. The validation has been performed using as reference the intra-arterial pressure measurement NIBP can work either in manual or automatic modes. In manual mode a measurement is performed only when Start/Stop NIBP key is pressed. In automatic mode, the measurement is performed at regular intervals. The time interval between measurements is selectable by the user. In automatic mode the user can start a measurement at any time by pressing the Start/Stop NIBP key and the next measurement would start once the selected time interval has elapsed. If Start/Stop NIBP key is pressed while a NIBP measurement is in progress, the process is stopped and the cuff deflated. During the measurement a button is also shown in the main menu area that, when pressed, stops the process.
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