Search Results

The STS device is intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS device is to be used by either a physician, respiratory therapist, or technician. The STS device is intended to be used in a professional healthcare environment.

The STS is a handheld spirometer intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS is to be used by either a physician, respiratory therapist, or technician. The STS device is pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters. It is a multi-use device that should be used with a compatible single-use, disposable mouthpiece which incorporates a viralbacterial filter protecting the patient from the internal components of the device is battery operated allowing for approximately 40 operating hours between charges. The measurement results, which are transmitted via Bluetooth, are displayed on the physician's computer via the STS software/App.

The Vyntus/SentrySuite Product Line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET) parameters, aiding in the diagnosis of related conditions. The results of the test can be viewed online with the help of a computer screen and can be printed after the test results can be saved for future reference or report generation purposes. The products can be utilized with patients age 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities). A qualified physician has to reassess all Vyntus/SentrySuite measurements. An interpretation by Vyntus/SentrySuite is only significant if it is considered in connection with other clinical findings. Additional for Vyntus ECG: The Vyntus ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on the screen or printed on paper. 12-lead ECGs are analyzed automatically and suggestions for the interpretation of the resting ECG can be made by the software. ECG interpretation statements made by the Vyntus/ SentrySuite represent partial qualitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements. The Vyntus ECG can be used for non-interpretive applications in patients age 4 years and older and a weight of 20 kg or higher. The Vyntus ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital). The Vyntus ECG is not intended for intracranial use. The Vyntus ECG is not intended for use in an EMS environment (Emergency Medical Services Environment). The Vyntus ECC is not intended for use in home healthcare environments. Automatic interpretation of the ECG is not possible for pediatric and adolescent patients below 16 years of age and for patients with pacemakers.

Option Hi/Lo FiO2: The High/low FiO2 option of the Vyntus CPX is designed to measure the ventilation and the gas exchange (02 uptake, CO2 production) of a subject with varying inspiratory concentrations of O2.

The Vyntus BODY is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for future reference or report generation purposes. The products can be utilized with patients aged 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities). A qualified physician has to reassess all Vyntus BODY measurements. An interpretation by SentrySuite is only significant if it is considered in connection with other clinical findings.

The Vyntus BODY is a whole-bodyplethysmograph and consists of the Vyntus BODY cabin, an ultrasonic flow sensor (USS), and a shutter. The Vyntus BODY system allows the determination of a subjects' pulmonary function status. It includes the determination of the subjects' ventilatory flows and volume by means of the USS. The measurement of the lung diffusion by the DLCO technique is accomplished with the supply of test gas and the gas analyzers for methane (CH4) and carbone monoxide (CO). All variants are stationary and not battery operated. The sensor data is sent to a host computer system via cable connection for processing, storage, and reporting. The host computer can be networked via LAN, WLAN, or Internet. All measurements are performed with the use of the Windows based operating software SentrySuite (SeS). The SeS software also stores the measurement results and provides output capabilities. The host computer, monitor, and printer are mounted on the Vyntus Cart. Use of the cart is optional; computing equipment may be placed on other furniture.

The Vyntus ONE / SentrySuite product line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET) parameters, aiding in the diagnosis of related conditions. The results of the test can be viewed online with the help of a computer screen and can be printed after the test results can be saved for future reference or report generation purposes. The products can be utilized with patients aged 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities). A qualified physician has to reassess all Vyntus / SentrySuite measurements. An interpretation by Vyntus ONE / SentrySuite is only significant if it is considered in connection with other clinical findings. Additional for Vyntus ECG: The Vyntus ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on the screen or printed on paper. 12-lead ECGs are analyzed automatically and suggestions for the interpretation of the resting ECG can be made by the software. ECG interpretation statements made by the Vyntus / SentrySuite represent partial qualitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements. The Vyntus ECG can be used for non-interpretive applications in patients age 4 years and older and a weight of 20 kg or higher. The Vyntus ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital). The Vyntus ECG is not intended for intracranial use. The Vyntus ECG is not intended for use in an EMS environment (Emergency Medical Services Environment). The Vyntus ECG is not intended for use in home healthcare environments. Automatic interpretation of the ECG is not possible for pediatric and adolescent patients below 16 years of age and for patients with pacemakers.

The Vyntus ONE is a full pulmonary function test (PFT) system, consisting of a main unit with the gas analyzers and electronics inside, a patient interface with a Flow Path Valve eDemand and an electronic demand valve inside and an ultrasound flow sensor (USS). The entire equipment is mounted on a cart which includes the isolation transformer and the support arm for the patient interface and the USS. The Vyntus ONE is connected via USB interface to the desktop PC and enables the following standard measurements: - Diffusion SB Realtime - Diffusion SB Intra-breath - FRC N2 washout - Slow/forced spirometry and MVV The Vyntus ONE also supports cardiopulmonary exercise testing (CPET). The specific hardware consists of the light-weight digital volume transducer (DVT) and an optional SpO2 pulse oximeter. It enables the following standard measurement features: - Breath-by-breath (BxB) gas exchange - Workload control for bicycle ergometer or treadmills - Automatic workload protocols Further optional hardware and software include: - Vyntus ECG: 12-lead Electrocardiogram (ECG) recording (resting and stress ECG) - ROcc, P0.1, MIP / MEP measurements

The COSMED K5 Wearable Metabolic Technology is a device designed to measure cardio-respiratory and metabolic functions during stress testing, rehabilitation, sports medicine and other related activities, performed in professional healthcare facilities only. The system is not intended for Home Use. The main measurements reported by the system are Oxygen Uptake production, Ventilation, Heart Rate and Energy Expenditure. K5 is intended to use with adults and children over the age of 14 years. It is to be used by physicians or by trained personnel on a physician responsibility. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It must not be intended as a monitoring device, nor as a sole means for determining a patient's diagnosis but for the purpose of assisting the clinician in the diagnosis of cardio-pulmonary diseases

The COSMED K5 Wearable Metabolic Technology is a portable unit, designed for the measurement of resting and exercise metabolism in the laboratory, utilizing international measurement quidelines published by relevant scientific societies. The K5 consists of the following main parts: - Main portable unit - Optional Bluetooth receiver - PC software - Face mask with head cap - Turbine flowmeter with optoelectronic reader and wind cover - Harness - Heart rate monitor belt - 02 sensor - Battery charger + batteries - AC/DC adapter - USB cable - Carrying case - Optional pressure regulator for calibration The K5 system is intended to be used the laboratory, by either direct connection or by telemetry. The system offers both 'breath-by-breath' and 'mixing chamber' operational modes.

The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by a physician, respiratory therapist, or technician in a hospital or clinic setting

The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by either a physician, respiratory therapist, or technician. A cleared single-use, disposable viral-bacterial filter separates the patient from the internal components of the device. The MiniBox+ measures all common spirometric measurements as well as relative and absolute lung volumes and diffusing capacity. The MiniBox+ is equipped with a diffusing capacity module which is embedded into the MiniBox+ enclosure and located in the upper end of the device. This feature allows easy measurement of the volumes and concentrations (CO and CH4) of inspired and expired breath, of the test gas mixture and patient sample respectively, making possible the calculation of the diffusion capacity [DLco]. MiniBox + DLco [diffusing capacity factor of the lung for carbon monoxide (CO)] module uses the single breath concept and enables the measurements by setting and controlling the maneuver stages as defined in ATS/ETS DLco guidelines.

The Vyntus/SentrySuite Product Line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET) parameters, aiding in the diagnosis of related conditions. The results of the test can be viewed online with the help of a computer screen and can be printed after the test results can be saved for future reference or report generation purposes. The products can be utilized with patients age 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities). A qualified physician has to reassess all Vyntus/SentrySuite measurements. An interpretation by Vyntus/SentrySuite is only significant if it is considered in connection with other clinical findings. Additional for Vyntus ECG: The Vyntus ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on the screen or printed on paper. 12-lead ECGs are analyzed automatically and suggestions for the interpretation of the resting ECG can be made by the software. ECG interpretation statements made by the Vyntus/ SentrySuite represent partial qualitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements. The Vyntus ECG can be used for non-interpretive applications in patients age 4 years and older and a weight of 20 kg or higher. The Vyntus ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital). The Vyntus ECG is not intended for intracranial use. The Vyntus ECG is not intended for use in an EMS environment (Emergency Medical Services Environment). The Vyntus ECC is not intended for use in home healthcare environments. Automatic interpretation of the ECG is not possible for pediatric and adolescent patients below 16 years of age and for patients with pacemakers.

The Vyntus ECG is the perfect 12-Lead PC-ECG extension for the Vyntus CPX via secure Bluetooth® communication. One integrated solution through the SentrySuite platform helps laboratories ease procedures and integration to reduce costs. The Vyntus ECG records the full 12-lead resting and stress ECG via its wireless, battery operated ECG amplifier. The evaluation and interpretation is using the proven Hannover ECG System (HES). Scientific Concept: The surface electrodes of the Vyntus ECG record the electrical signals that are mainly generated by the heart muscle activity and repolarization. The small voltages are amplified and A/D converted. A low frequency high-pass filter is applied and the recorded signals are transmitted to the PC for recording, storing, evaluation, interpretation, display and reporting. Significant performance characteristics: - Full 12 lead ECG - Small, low weight (<300 g) - Data transfer by blue-tooth - Single AA battery operation - Pacemaker detection with 4000 Hz sample rate - 500 Hz per channel transmission rate - Bandwidth: 0.05-150 Hz - Resolution: < 2.5 µV/bit - Classification applied parts; CF, defibrillator proof - Automatic analysis by HES stress/resting algorithm package - Online evaluation and display of HR, ST-values and ST-slope - Arrhythmia detection - Different views - Rhythm view - Trace view - Full disclosure view (result view) - Different filters selectable - 50/60 Hz - Baseline - Muscle (20, 40, 100 Hz) - Continuous storage of raw ECG data for stress application

The Vyntus/SentrySuite product line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET) parameters, aiding in the diagnosis of related conditions. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for future reference or report generation purposes. The products can be utilized with patients age 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities).

The Vyntus CPX system is an accurate and reliable system that allows the determination of a subjects' metabolic response while exercising. It is a stationary, mains powered ergospirometry system. The system records the data breath-by-breath. The breath-by-breath data is collected through a facemask or mouth-piece and is sent to a host computer system via cable connection. The digital volume transducer (DVT) measures the gas volume in- and expired. Gas samples are continuously drawn from a location very close to the mouth (between DVT and the face-mask or mouth-piece). The gas samples are dryed by Nafion tubes and analyzed for O2 and CO2 content. From the breathing volume and the differences between inspiratory and expiratory O2 and CO2 concentrations the oxygen uptake and the CO2 production (V'O2 and V'CO2) are calculated by the software. The workload protocol selected by the user will control the ergometer device accordingly and the changes in the above vital signs due to the change in workload are recorded. All data is stored together with the patient and test data in the database for later evaluation and printing.

The PulmOne MiniBoxPFT is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT is to be used by either a physician, respiratory therapist, or technician.

The MiniBoxPFT™ is a table-top pulmonary function testing (PFT) device that measures both spirometry and lung volumes. It is developed and manufactured by PulmOne Advanced Medical Devices, Ltd. The MiniBoxPFT™ is composed of two modules: an OEM 510(k) cleared Spirometry module and a Lung Volume Measurement (LVM) module. A single-use, disposable viral-bacterial filter separates the patient from the internal components of the modules.

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.