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The AirLife DuoTherm™ Heated Humidifier is intended to add moisture to, and warm, the breathing gases for administration to a patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. This product is non-sterile, reusable, and intended to be used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Humidification Chamber is intended to hold water required to humidify breathing gases delivered to patients ranging from neonates to adults using a heated humidifier. The product is a single use device, nonsterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Neonate Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Neonate Heated-Wire Circuits are used with a pediatric population, specifically the neonate (birth to 28 days) and infant (29 days to 2 years) pediatric subgroups with an ideal body weight of 0.5 to 8kg that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Neonate Heated-Wire Circuits are used for flow rates greater than 1 LPM. The product is single patient use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Pediatric Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Pediatric Heated-Wire Circuits are used with the pediation, specifically infant (29 days to 2 years) and children (2 years) with an ideal body weight of 6 to 42kg that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Pediatric Heated-Wire Circuits are used for flow rates greater than 2 LPM. The product is single use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Adult Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire Circuits are used with the adult population and pediation, specifically those with an ideal body weight of 30kg or above, that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Adult Heated-Wire Circuits are used for flow rates greater than 3 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Adult Heated-Wire NIV Circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire NV Circuit is used with the spontaneously breathing adult population (>21 years), specifically those with an ideal body weight of 30kg or above, that benefit from high flow therapy. The Adult Heated-Wire NIV Circuits are used for flow rates greater than 5 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Humidification System is used to deliver heated, humidified breathing gases to a patient's airway when he/she is mechanically ventilated, receiving continuous noninvasive (NIV) positive airway pressure or high-flow oxygen therapy. The system is intended for use in a standard hospital or professional health care environment. The AirLife DuoTherm™ Humidification System consists of: - A heated humidifier, which includes reusable temperature probes, heated wire adapters, and a power cord, - A humidification chamber, and - . Heated wire circuits, which include neonate, pediatric, and adult single and dual limb circuits, as well as an adult heated wire NIV circuit.

LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilator support for the care of the individuals who require mechanical ventilation. The use environment is for institutional use. Institutional use includes ICU or other hospital environments including intra-hospital transport. The model 2200 can operate with high pressure O2. The model 2150 operates with low pressure oxygen. TheLTV2 Series Ventilators are intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following types of ventilatory support: - . Positive Pressure Ventilation, delivered invasively or non-invasively (via mask). - . Assist/Control, SIMV, CPAP, and NPPV modes of ventilation. The ventilator is suitable for use in professional healthcare facilities, including during intrahospital transport.

The LTV2 Series ventilator supports adult and pediatric patients weighing at least 10 kg (22 lb) in professional healthcare facilities response with invasive or noninvasive ventilation presets. These settings can be easily refined using the touch-turn-touch interface on the LED display. The ventilator also provides a wide range of ventilation therapies to meet demanding patient needs, including volume control, pressure control, pressure support and spontaneous breath types. Combined with the spontaneous breathing trial function, the ultra-sensitive flow trigger facilitates weaning patients weighing at least 10 kg (22lb).

The Multi-Link X2 ECG Cable and Leadwire System is intended to transmit ECG signals from patient electrodes to patient monitors for monitoring purposes. The Multi-Link Cable and Lead Wire System is limited to indications for use of the connected monitoring equipment. The Multi-Link trunk cables) are reusable, nonsterile and can be reprocessed.

The Multi-Link™ X2 ECG Cable and Leadwire System is a product portfolio that is intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes. The system consists of Reusable Trunk Cables (K980582, K101660, K162432), Reusable Leadwires (K980582) and Disposable Single Patient Use Leadwires (K101660, K162432). The existing portfolio is compatible with the following ECG monitoring platforms: Philips, Mindray, Nihon Kohden, GE, and Spacelabs. The subject device of this pre-market notification consists of a modified set of Reusable Trunk Cables that are designed to be compatible with the following cardiac defibrillation systems: Physio Control Lifepak, Zoll R, and Zoll X monitoring platforms. The subject device is used to transmit signals from patient electrodes and sensors to support continuous ECG monitoring only. The subject device does not interpret or deliver the shock applied when the defibrillators are in use.

The Multi-Link™ X2 ECG Adapters and Leadwires are used to transmit ECG signals from the electrodes to ECG monitors for monitoring purposes. The Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link Direct-Connect Leadwires are single-patient-use, nonsterile and cannot be reprocessed. The Multi-Link X2 ECG Adapters and Direct Connect Leadwire System are used with any patient population requiring ECG monitoring.

The Multi-Link™ X2 ECG Cable, Adapter and Direct Connect Leadwires is an FDA cleared accessory portfolio. The cleared device portfolio consists of adapters & leadwires (reusable adapters and direct connect disposable single patient use leadwires, K163316), and (leadwires reusable, and disposable single patient use, K162432). The cleared portfolio is compatible multiple FDA cleared ECG monitoring platforms, such as Philips, Mindray, Nihon Kohden, GE and Spacelabs. This pre-market notification is to expand the portfolio to be used with additional FDA cleared ECG monitoring platforms. The Subject device, Multi-Link ™ X2 ECG ADAPTER AND LEADWIRES consists of reusable adapters and direct connect single patient use leadwires that connect to FDA cleared Dräger Infinity (R) monitoring platforms. Design modifications are made to allow for connections with specific additional platforms to allow patients to move throughout the facility without the hassle of disconnecting and reconnecting leadwires. The system is used to transmit signals from patient ECG electrodes to monitoring equipment, providing patients with continuous ECG (electrocardiogram) monitorina. This device is common to both industry and medical establishments. The Multi-Link™ X2 ECG ADAPTER AND LEADWIRES is not a stand-alone device but is used with the host monitoring device and functions as conductors on the system to carry the electrical signals.

The Multi-Link™ X2 ECG Adapter and Lead Wire System are used in telemetry to transmit ECG and/or SpO2-signals from the electrodes and sensors to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link X2 ECG Adapter and Lead Wire System are used with any patient population requiring ambulatory monitoring, and are compatible with the Philips MX40 electrocardiograph monitor.

The Multi-Link™ X2 ECG AND SpO2 ADAPTERS is a reusable telemetry Adapter that connects the Philips IntelliVue MX40 (cleared under telemetry transmitter K172226), on one end to Vyaire-owned lead wires (cleared under K980582 and K101660) and market available SpO2 sensors (cleared under K172226 and K111888) on the other end. The Adapter functions to transmit signals from patient ECG electrodes and SpO2 sensors to ambulatory monitoring equipment, providing ambulatory patients with continuous ECG (electrocardiogram) and SpO2 (blood oxygen saturation) monitoring. This device is common to both industry and medical establishments. The Multi-Link X2 ECG and SpO2 Adapter is not a stand-alone device but is used with the host monitoring device and functions as conductors on the system to carry the electrical signals.

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 Vital Signs Gas Sampling Lines are intended to connect from a port in the breathing circuit to the expired gas monitor. These gas sampling lines are used with GE Healthcare Compact Airway modules and CARESCAPE Respiratory modules for monitoring CO2, O2, N2O and anesthetic agents and with E-miniC for monitoring CO2.

Vital Signs Gas Sampling Lines consists of a disposable single patient use coextruded gas sampling line that is compatible with GE Healthcare Compact Airway, E-MiniC and CARESCAPE Respiratory Modules and are provided in four different lengths: 2 meters, 2.5 meters, 3 meters and 6 meters. The disposable single patient use gas sampling lines are smooth narrow diameter tubes that have standardized male luer connectors at both ends. The gas sampling line connects from a port in the breathing circuit to an expired gas monitor. The gas sampling line provides a conduit for drawing gas samples from the breathing circuit port to the gas monitor to analyze respiratory gases. These disposable single patient use gas sampling lines are used to transmit one directional flow of gas sample from the patient breathing circuit port to the gas module host device. A vacuum source and gas measurement sensors are located in the host device, which pull the gas from the breathing circuit port to the host device for gas monitoring. The gas sampling lines are accessories to the gas monitoring devices.