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510(k) Data Aggregation

    K Number
    K972798
    Device Name
    DYNEMO 3000
    Manufacturer
    SOMETEC, INC.
    Date Cleared
    1998-02-24

    (211 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOMETEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Adults (Transesophageal Probe Model 200-018) - Non-invasive, continuous, real-time measurement and monitoring of the aortic blood flow for adult patients under anesthesia and/or in intensive care. - Derivation of real-time composite hemodynamic profile (aortic blood flow, arterial pressures, heart rate, stroke volume in the aorta, end-tidal CO2 pressure, systemic vascular resistances for aortic circuit, systolic time intervals), providing indications of cardiovascular status. 2. Pediatrics (Transesophageal Probe Model 200-019) - Non-invasive, continuous, real-time measurement and monitoring of the aortic blood flow for pediatric patients under anesthesia and/or in intensive care. - Derivation of real-time composite hemodynamic profile (aortic blood flow, arterial pressures, heart rate, stroke volume in the aorta, end-tidal CO2 pressure, systemic vascular resistances for aortic circuit, systolic time intervals), providing indications of cardiovascular status.
    Device Description
    The DYNEMO 3000 is a non-invasive hemodynamic diagnostic device designed to provide the anesthesiologist, cardiologist, and intensive care physician with a noninvasive continuous hemodynamic profile derived from measurement and monitoring of the aortic blood flow (ABF) in real time. The DYNEMO 3000 is designed to operate in a clinical setting in which an adult or pediatric patient is under anesthesia and/or in intensive care. This type of monitoring device also offers the anesthesiologist and intensive care physician the capability of tracking critical parameters providing indications on the patient's cardiovascular status. The DYNEMO 3000's principle of operation is based on the simultaneous. realtime ultrasound measurement of aortic diameter and blood velocity, independently. This is achieved by inserting an endo-esophageal (or transesophageal) probe equipped with two (2) ultrasonic transducers is inserted into the patient's esophagus either trans-orally or trans-nasally. The measurement of the descending aortic diameter is made through M-Mode echo ultrasonography at a 10 MHz frequency. A thin beam resulting from the 10 MHz ultrasonic wave, produces high resolution images of the aortic walls. Through the manual rotation of the probe's distal end by the user, the M-Mode signal can be optimized, thereby providing an accurate measurement of the instantaneous aortic diameter. A second transducer measures the Doppler signal. The 5 MHz Doppler velocimeter allows for the precise velocity measurement over the section of the aorta. These two (2) ultrasound measurements are combined in real-time to provide an accurate measurement of the aortic blood flow (ABF) in the descending aorta. The microprocessor based DYNEMO 3000 unit communicates with external peripheral monitors including ECG, non-invasive blood pressure, and capnograph. A specialized software then synchronously combines data with that from these peripheral monitors to continuously display the composite hemodynamic profile of the patient in real time: - · Aortic blood flow. - · Arterial pressures, - · Heart rate. - · Stroke volume in aorta, - · Total systemic vascular resistance for aortic circuit - · Systolic time intervals, and, - · End-tidal CO2 pressure. The DYNEMO 3000 consists of five primary components: - · the main console. - · the transesophageal probe, - · the disposable silicone sheath including an inflatable balloon, - · the probe support, and, - · the probe cable. The main console provides various indicators and controls designed to lead the operator through the sequential procedures needed for the operation of the DYNEMO 3000 device. It contains a 7" screen used to display the parameters and the charts associated with the patient's ABF measurement. The console also houses the electrical components, and a data recording unit. The device operates from a 100-240V supply. The adult and pediatric transesophageal probe is comprised of a flexible "insertion tube", a sensor tip, and a mechanical head. The flexible "insertion tube" is used for mechanical and electrical connection between the mechanical head and the sensors. It is fitted with a sliding O ring indicator to mark the depth of insertion. A cable located inside of the insertion tube can rotate along its axis without movement of the outer casing. The sensor tip, comprises of two (2) piezo-electric transducers. The mechanical head rotates axially with an index that moves in front of another reference index located on the fixed section. This constitutes the onentation mechanism of the ultrasound transducers. A fixed section supports a lock and tap for filling and emptying a silicone balloon sheath. This section also permits to lock the transesophageal probe to the flexible probe support. A single-use, disposable adult or pediatric balloon sheath is chosen according to the selected probe, and the transesophageal probe is inserted inside the balloon sheath which then covers the entire probe, including the sensor tip. When filled with de-mineralized water, the balloon sheath inflates up to the esophageal wall, immobilizes the probe into the esophagus, directs the ultrasound sensors to the aortic target, and guarantees a parallel positioning between the sensor sub-assembly and the axis of the aorta. The mechanical head of the transesophageal probe remains fixed adjacent to the patient's head and is locked to the patient's operating table or bed with a probe support.
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