Search Results

The Hi-Ox® High FiO2 Mask with the Aerosol Adapter is intended as an accessory for compatible nebulizers. The mask with adaptor is intended to enable the delivery of nebulized drugs to patients who also require elevated inspired oxygen concentrations.

The Aerosol Adapter for the Hi-Ox® is an adapter that enables standard small-volume nebulizers (use only cup type, gas driven nebulizers without tee-fittings or air entrainment ports) with either 18 mm OD or 22 mm ID outlet ports to be adapted to the Hi-Ox®. This will enable patients to be treated with nebulized products while receiving high concentrations of oxygen at moderate flow rates of 8 -10 lpm. The valves in the Hi-Ox® have been tested and found to function normally after nebulization of some commonly nebulized drugs in aqueous formulations. However, the valves could malfunction if the prescribed drug creates a sticky residue on the valves. The practitioner should observe the patient's respiration and the function of the Hi-Ox valves during and after nebulization of drugs via the Hi-Ox80. The Aerosol Adapter is a simple right angle fitting made of Santoprene, a medical grade thermoplastic elastomer material. The adapter can be snapped into a normally plugged port on the Hi-Ox® just below the mask and between the inhalation-exhalation valves. This location for the adapter places nothing between the nebulizer and the patient's airway so as to not impact any of the particles produced by the nebulizer. The qas driving the nebulizer can supplement the normal oxygen supply for the Hi-Ox®, and any flow in excess of what is required by the patient can exit the mask via the normal exhalation pathway. There is no risk of pressure buildup beyond that of the cracking pressure and flow resistance of the exhalation valve (~ 1 cmH2O/L/sec). This enables the patient to receive their nebulizer treatments while maintaining an elevated FiO2.

The Infant Flow Plus System consisting of a Driver and Generator plus NCPAP Prongs and Masks, is intended for the provision of Bi-Level CPAP (SiPAP) to produce a sigh. The system is for use in Hospitals, Hospital-type facilities and intra-Hospital transport environments and is indicated for the treatment of Newborn and Infant patients.

The Infant Flow Plus System is a factory-installed modification to the Infant Flow Plus System. It uses the existing manually operated air / oxygen mixer and CPAP flow control. An ancillary manual flow control with electronic control solenoid valve allows timed delivery of augmented flow and pressure. The modification is housed in a robust enclosure that is designed to "piggy back" on to the existing Infant Flow Driver Unit.

The Lyra™ Nasal Mask is intended for use with devices that deliver Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure in treating adult patients.

The Lyra™Nasal Mask is intended for the delivery of air from either a CPAP or bi-level instrument (delivery device). The breathing circuit consists of the Lyra, which directly interfaces with the patient, and a pair of tubes, which connect the Lyra to the delivery device. The delivery device provides positive pressure air to the patient via the tubes and the Lyra™. Exhalation ports on the Lyra™ allows patient-exhaled gases to exhaust to the atmosphere. The Lyra™ consists of the following: - two nasal prongs, which are easily removed or installed into a mask body for the interchange of different sizes, and for easy cleaning of the device; - adjustable head gear, which keeps the nasal mask in place during use; - a pair of tubings, with one end of the tubings attached to the mask body; - a standard 22-mm swivel which attached to the other end of the tubings. The delivery device interfaces with the swivel via corrugated tubing, with a standard 22mm fitting. The Lyra™ nasal prongs, made from a soft, flexible silicone, form a seal with the patient's nares. The nasal prongs come in different sizes for better and more comfortable fit for patients with varying nares sizes. The Lyra™ is packaged, along with instructions for use and recommended cleaning instructions, in a poly bag. The Lyra™ can be completely disassembled for cleaning. Mild soap and water may be used to clean the device.

The Pegasus™ Nasal CPAP System is intended for treatment of Adult Obstructive Sleep Apnea (OSA). The Pegasus™ Nasal CPAP System is intended only for spontaneously breathing patients.

The Pegasus™ Nasal CPAP System is intended to provide a requlated and continuous positive airway pressure for the treatment of adult individuals suffering from obstructive sleep apnea (OSA). The positive pressure is clinicianadiustable within the designed operating range, as is enabling of the bar graph pressure indicator mode. User controls are On/Off switch, selecting the physician-enabled bar graph, viewing the real-time clock and setting of the real-time clock. The Pegasus™ is designed to be used with a 22-millimeter, smooth-bore air delivery hose and user- or physician-selected nasal or face mask. The Pegasus™ consists of a plastic enclosure that surrounds a power supply, impeller and motor, microprocessor, motor controller, display and switch inputs.

The Hi-Ox® High FiO2 Mask is intended to deliver high inspired oxygen concentrations to patients who require elevated inspired oxygen.

The HI-Ox80 is an oxygen mask to enable patients to inhale high concentrations of oxygen at moderate flow rates of 8 -10 |pm. It is a simple device consisting of a central manifold section where the patient mask, oxygen tubing and an oxygen reservoir bag attach. The triple valving in the manifold directs the oxygen to the patient and acts as an anti-asphyxiation valve removing the need for ventilation holes in the mask itself, thus allowing for delivery of high FiO2's. Oxygen from the supply is either delivered to the patient via a one-way valve (inhalation valve) or stored temporarily in the oxygen reservoir bag. During exhalation, expired gas is directed to the atmosphere via another one-way valve (exhalation valve). In the event the patient's minute ventilation exceeds the oxygen supply flow rate, a third sequential dilution valve allows ambient air to get drawn into the inspired limb of the manifold eliminating the potential for asphyxiation. The inhalation and exhalation one way valves are designed to have very low flow resistance (less than 1,5 cmH,O, typically ~ 1.07 cmH2O at flow rates of 60 lpm) to minimize the work of breathing. The sequential dilution valve is specified to be less than 3 cmH2O/U/sec. The oxygen mask is made of a soft material for conformance to the patient's facial contours. Positioning of the manifold connection on the mask minimizes the effective deadspace.

The SomnoStar a Series Sleep System is intended to assist the user in diagnosing patients with sleep disorders by collecting physiological data from a sleeping patient, assisting the user in performing analysis of sleep data, and printing a hard-copy report of these data. The SomnoStar a Series Sleep System is indicated for use to assist the user(s) In diagnosing patients with sloep disorders; by collecting physiological data from a sleeping patient, assisting the user(s) in performing analysis of sleep data and printing a hard copy of these data. The data is collected, staged and scored with a computerassisted program.

The SomnoStar a Sleep System receive Input from bio-physical amplifiers, analyze these data according to software programs designed for use on computer systems included in the system configuration and output data in the form of reports generated by the printer option to the systems. Various components of the systems can be designed into already-existing sleep laboratories. A more detailed description is contained in the Operator's Manual. In use, the SomnoStar a Series Sleep System receives input from optional bloghysical amplifiers, up to 32 channels in each, which is converted from analog to digital data and stored in a computer storage medium.

The SensorMedics SiPAP Infant Nasal CPAP Circuit, consisting of a pressure generator, Nasal CPAP Prongs and Masks, is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.

Detailed description of the device circuit is contained in the SiPAP Infant Nasal CPAP Operator's Instructions.

The SensorMedics Infant Flow System, consisting of a Driver and NCPAP Prongs, is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.

Infant Flow System, consisting of a Driver and NCPAP Prongs

The SensorMedics Infant Flow Nasal CPAP Mask is intended for use with the SensorMedics Infant Flow System, consisting of a Driver and NCPAP Generator. It is intended to provide CPAP with a nasal mask for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.

The SensorMedics Infant Flow Nasal CPAP Mask is a silicone mask that fits into the generator of the Infant Flow System in place of the standard nasal prongs.

The indications for use are the same as the Vmax Series to which this product is an option. Quotation from the Indications for Use section of the Vmax premarket notification: "Basically, this involves performing physicianprescribed pulmonary function and metabolic testing. More-specific intended uses are shown in the table below, along with the predicate SensorMedics product model with the same intended-use labeling." The Static and Dynamic Compliance option is indicated specifically for Evaluation of medication effects, Pulmonary Function testing in adults & children, Pulmonary disability evaluation, Industrial surveillance and Bedside lung function.

The Static and Dynamic Compliance software product option is identical in safety and effectiveness to the predicate devices listed in the last section. The technique of placing an esophageal balloon and derived measurements are also the same as the predicate devices. Static and dynamic compliance are measurements of pulmonary function. also commonly referred to as Respiratory Mechanics. The mechanical properties of the respiratory system are important to breathing effectively. In healthy people, the elastic recoil and compliance of the lung are easily managed by the respiratory muscles allowing normal breathing. In some common respiratory diseases, there are changes in recoil and compliance. Static and dynamic compliance are easily measured and can be valuable in determining the effects of lung disease on breathing. Static and dynamic compliance are performed by having the patient swallow an esophageal balloon that is connected to a calibrated pressure transducer, The patient breathes quietly on a mouthpiece connected to a flow meter. while mouth pressure, esophageal pressure, flow rate and volume changes are measured. The balloon is placed in the esophagus just above the diaphragm. This position is determined by having the patient breath through a flow meter, while the operator views a display of esophageal pressure, inspiratory flow and expiratory flow on a computer monitor. The operator looks for a negative pressure-tracing concomitant to a positive flow tracing. If the pressure tracing is positive, the balloon has passed the level of the diaphragm and needs to be pulled back until a positive tracing is displayed. When measurements are made under no-airflow conditions, Static Compliance is calculated. When the measurements are made under flow conditions, Dynamic Compliance is calculated.