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The LCI Option for Innocor is intended to measure the Lung Clearance Index (LCI), which is the cumulative expired volume required to clear an inert gas from the lungs during normal breathing in a multiple-breath washout (MBW) test divided by the Functional Residual Capacity (FRC).

Innocor is a compact point-of-care device intended to be used for non-invasive measurement of a) cardiac output (CO) and other hemodynamic parameters utilizing inert gas rebreathing (IGR) technology, b) metabolic parameters including oxygen uptake by means of a breath-by-breath gas exchange method, c) spirometry parameters by means of forced respiratory maneuvers, and d) peripheral airway function by means of multiple-breath inert gas washout. The basic Innocor provides cardiac output (CO) as the principal measured parameter. Utilizing inert gas rebreathing, Innocor measures the relative levels of two inhaled gases of differing blood solubility over approximately 3-4 respirations. The disappearance curve for the blood soluble gas is used to calculate pulmonary blood flow (PBF), which in the absence of a significant intrapulmonary shunt is equal to cardiac output. The functional residual capacity (FRC) is determined from the dilution of the relatively insoluble gas during the same maneuver. The LCI Option for Innocor, used alone or in conjunction with the entire Innocor system, provides information on lung volume and peripheral airway function. The LCI is calculated as the cumulative expired volume (VcE) required to clear the inert tracer gas from the lungs during normal breathing, minus the product of the number of wash-out breaths and the external dead space outside the lips. divided by the subject's Functional Residual Capacity (FRC). FRC is the amount of air that stays in the lungs (up to the lips) after a normal expiration. In other words, LCI represents the number of lung volume turnovers (i.e. FRCs) that the subject must breathe to clear the inert tracer gas from the lungs (by convention, to an end-tidal concentration of 1/40th of the starting concentration over three subsequent breaths). Innocor uses a combination of two techniques to determine the LCI, using SF6 as the inert tracer gas: Inert gas rebreathing (IGR) is used for rapid wash-in of a very small amount of SF% until an even concentration is obtained in the lungs before the wash-out can start. This allows accurate determination of the functional residual capacity (FRC) by gas analysis alone. This is followed by multiple-breath wash-out (MBW) for determination of the cumulative expired volume (VCF) required to clear the SF6 from the lungs. The Innocor device is a compact and portable point-of-care device. The hardware in the LCI Option for Innocor is identical to that used in the Innocor Diagnostic Programmable Computer (K051907) and the Cardiopulmonary Exercise Testing Option to Innocor (K071911). The combined rebreathing/multiple breath wash-out test performed with the LCI Option for Innocor requires accurate measurements of the respiratory flow and the concentration of SF6 at the mouth during inspiration (inhalation) and expiration (exhalation). The Innocor device measures the flow and SF6 concentration by means of of a pneumotachometer and a photoacoustic infrared gas analyzer, respectively, while the patient takes multiple breaths over a period of time through a pneumatically activated respiratory valve unit (RVU). The rebreathing gas mixture for wash-in of SF6 is filled into a rubber bag prior to testing.

The Spirometry Option for Innocor is intended to be used as a diagnostic spirometer, used in pulmonary function testing, to measure the flow of gas moving into and out of a patient's lungs. In order to produce data regarding the maximum performance with respect to tidal volume and ventilation, the specific parameters measured by the Innocor Spirometry Option are: FEV1: Forced expiratory volume in one second FVC: Forced vital capacity FEV1%: FEV1/FVC PEF: Peak expiratory flow MEF 75*: Maximum instantaneous forced expiratory flow where 75% of the FVC remains to be expired MEF 50*: Maximum instantaneous forced expiratory flow where 50% of the FVC remains to be expired MEF 25*: Maximum instantaneous forced expiratory flow where 25% of the FVC remains to be expired FET: Forced expiratory time MVV: Maximum voluntary ventilation * MEF 75 is equal to FEF 25 (maximal instantaneous forced expiratory flow where 25% of the FVC has been expired); MEF 50 is equal to FEF 50; MEF 25 is equal to FEF 75.

Innocor is a compact point-of-care device intended to be used for non-invasive measurement of a) cardiac output (CO) and other hemodynamic parameters utilizing inert gas rebreathing (IGR) technology, and b) metabolic parameters including oxygen uptake by means of a breath-by-breath gas exchange method. The Cardiopulmonary Exercise Testing Option to Innocor provides measurements of gas exchange parameters including oxygen uptake (VO2), carbon dioxide excretion (VCO2), ventilation (Vr) and end-tidal gas concentrations plus a number of derived parameters. These parameters are determined by simultaneous measurements of the respiratory flow and gas concentrations when breathing ambient air. The respiratory flow is measured by means of a differential pressure type flowmeter (pneumotachometer) placed between the respiratory valve unit and the patient. The gas exchange calculations are carried out online for each breath between the rebreathing tests, providing the opportunity to perform an incremental exercise test on a bicycle ergometer or treadmill and measure the progress of cardiac function, pulmonary function and gas exchange at the same time. Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. Spirometry is recognized as a valuable screening test of general respiratory health. The Spirometry Option for Innocor measures the subset of spirometric variables of a patient during a forced expiration testing procedure. These measured variables include FEV1 (forced expiratory volume in 1 second), FVC (forced vital capacity), FEV . PEF (peak expiratory flow), MEF 75 (Maximal instantaneous forced expiratory flow where 75% of the FVC remains to be expired), MEF 50, MEF 25, FET (Forced expiratory time) and MVV (Maximum voluntary ventilation). These parameters are determined by measurements of the respiratory flow when breathing ambient air during a spirometry test of a patient (tidal breathing followed by a full inspiration and then finally a maximal forced expiration). The respiratory flow is measured by means of a pneumotachometer.

A cardiopulmonary exercise testing option is available for Innocor. This option provides breath-by-breath measurements of flow, oxygen uptake and carbon dioxide production. It is intended to measure oxygen uptake (metabolic rate) and related parameters to objectively and non-invasively assess cardiac and pulmonary function at rest and during exercise. With the cardiopulmonary exercise testing option, Innocor provides values for: Main metabolic parameters: Oxygen uptake, Carbon dioxide excretion, Expiratory minute ventilation. Calculated/derived parameters: Oxygen uptake per kg, Respiratory exchange ratio, Alveolar ventilation, Anatomical dead space (Fowler dead space), Tidal volume, Respiratory rate, End-tidal concentration of oxygen, End-tidal concentration of carbon dioxide, Expiratory quotient / ventilatory equivalent for oxygen, Expiratory quotient / ventilatory equivalent for carbon dioxide. And the following calculated parameters after an incremental exercise test: Anaerobic threshold, Respiratory compensation, Rest values, Values at AT point, Values at max exercise.

Innocor is a compact point-of-care device intended to be used for non-invasive measurement of a) cardiac output (CO) and other hemodynamic parameters utilizing inert gas rebreathing (IGR) technology, and b) metabolic parameters including oxygen uptake by means of a breath-by-breath gas exchange method. The Breath-by-Breath option provides measurements of gas exchange parameters including oxygen uptake (VO2), carbon dioxide excretion (VCO2), ventilation (VE) and end-tidal gas concentrations plus a number of derived parameters. These parameters are determined by simultaneous measurements of the respiratory flow and gas concentrations when breathing ambient air. The respiratory flow is measured by means of a differential pressure type flowmeter (pneumotachometer) placed between the respiratory valve unit and the patient. The gas exchange calculations are carried out online for each breath between the rebreathing tests. This gives the opportunity to perform an incremental exercise test on a bicycle ergometer or treadmill and measure the progress of cardiac function, pulmonary function and gas exchange at the same time.

Innocor is indicated for the determination of a number of hemodynamic parameters. Cardiac Output (CO) is the principal measured parameter. Utilizing inert gas rebreathing, Innocor measures the relative levels of two inhaled gases of differing blood solubility over approximately 3-4 respirations and calculates pulmonary blood flow (PBF). In the absence of a significant intrapulmonary shunt (arterial oxygen saturation ≤ 95% as measured by a pulse oximeter incorporated in the Innocor), PBF is equal to CC. As an optional accessory, Innocor includes a noninvasive Blood Pressure (NIBP) monitoring system. This option provides systolic, diastolic and mean arterial pressures. With the NIBP option, Innocor provides values for the following measured and calculated hemodynamic parameters: Cardiac Output, Arterial Oxygen Saturation, Heart Rate, Stroke Volume, Lung Volume, Cardiac Index, troke Index, Blood Pressures (Systolic, Diastolic, Mean Arterial), ystemic Vascular Resistance, Systemic Vascular Resistance Index.

Innocor is a compact point-of-care device intended to be used for measurement of a) cardiac output (CO) utilizing inert gas rebreathing (IGR) technology and b) other hemodynamic parameters. Two Models will be made available initially in the U.S: Innocor, Innocor with NIBP option. With the NIBP module option, the device will provide values for the hemodynamic parameters included in the Indications for Use below.