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The intended use of the Device is to generate and deliver USP 93% oxygen for supplemental oxygen use only or filling cylinders. The device must not be used for or with any life-supporting applications. The Device is intended to be used only by trained personnel in hospitals, health care facilities or remote locations where bottled oxygen is not readily available. The instruction manual of the device recommends an alternate source of supplemental oxygen in the event of a power outage, alarm condition, or mechanical failure.

Air contains 21 % oxygen, 78% nitrogen, 0.9% argon, and 0.1% other gases. AirSep PSA Oxygen units separate this small percentage of oxygen from the compressed air through a unique Pressure Swing Adsorption (PSA) process. The compressed air flows through a filter assembly before the air enters the adsorber vessels. A particulate/foam filter removes condensed water, oil, dirt, scale, etc. from the feed air, and then, a separate coalescing filter (if present) removes additional oil and water vapor. The oxygen generator uses in its adsorber vessels an inert ceramic material called molecular sieve to separate compressed air into oxygen and other gases. The unique properties of molecular sieve allow it to attract, or adsorb, nitrogen physically from air under pressure. This allows oxygen to exit the adsorbers as a product gas. While one adsorber produces oxygen, the other depressurizes to exhaust the waste gases it adsorbed (collected) during the oxygen production cycle. The entire oxygen generating process is completely regenerative, which makes it both reliable and virtually maintenancefree. The molecular sieve does not normally require replacement. The medical devices in this submission refer to the following oxygen concentrators manufactured by AirSep Corporation: | Model | Flow (scfh) | Oxygen Delivery<br>Pressure (psig) | |---------|-------------|------------------------------------| | Centrox | 32 | 50 | | Ultrox | 17 | 20 | | Reliant | 17 | 50 | All of these devices are designed to deliver the oxygen with USP 93 % purity. Centrox and Reliant units are also available for cylinder filling option. Ultrox is used only to fill cylinders. Centrox, Ultrox and Reliant units are comprised of an air compressor that uses ambient air to produce higher pressure feed air. These models have the same indications for use. Together these products are referred to as Device. The device is intended to be USP 93% oxygen generator. As such, to assure the purity, an Oxygen Analyzer is integrated in each device and an alarm is activated if the purity is outside of the safe range.

OxiScan II Oximetry Data Management Software (OxiScan II) is a central server based software system that uses a personal computer based application written in Microsoft Dot Net protocol to capture oximetry data from an oximeter, and then transmit this data, in a secure encrypted file, via internet, to the central server. At the central server the data is used to render a standard report that is then transmitted via fax and/or email to the prescribing physician. The intended use of the report is to provide a physician with information to help determine the best pulmonary treatment. The OxiScan II Oximetry Data Management Software is intended to collect, report and archive oximetry trend data to provide information to a medical professional, as a supplemental tool to assist in the timely identification of pulmonary needs. The OxiScan II Oximetry Data Management Software is intended to (1) transfer oximetry data from a pulse oximeter to a central server data base in order to maintain unique records per patient and test of this pulse oximetry data, and (2) to generate and archive standard reports drawn from this data. A list of approved oximeters appears in the Capture software. The OxiScan II Oximetry Data Management Software is not a diagnosis tool. It is a decision management support tool that allows medical personnel to securely and accurately upload and view data related to pulse oximetry and to provide output reports as feedback which may be used by a Heathcare professional to form a patient history.

OxiScan II Oximetry Data Management Software is an accessory for use with compatible pulse oximeters. OxiScan II Oximetry Data Management Software collects and stores patient information containing raw oximetery data captured by a pulse oximeter. This information is transferred by a personal computer to an internet Web server where a report which summarizes and graphically presents the data is prepared. This report is delivered to a Healthcare Professional who then uses it along with other information to determine a course of pulmonary treatment. The report may be retrieved, reviewed, and retransmitted via the OxiScan II Oximetry Data Management Software web site.

The portable AirSep LifeStyle Oxygen Concentrator is intended to provide supplemental, high-purity oxygen in a home, institutional, or travel environment.

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The HealthLife Oxygen Concentrator delivers supplemental oxygen in a nominal 9 liters-per-minute flow of 38% oxygen for inhalation with mask delivery to the patient.

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The Artisan™ is intended to be used by Physicians or trained technicians for acquisition of EEG and polygrasomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations commonly used in clinics. It does not involve any patient monitoring or diagnosis.

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The Airsep Mystique ultrasonic nebulizer is intended for use in the treatment of asthma, COPD and other respiratory ailments in which an aerosolized medication is required during therapy. It may be necessary to perform respiratory therapy at anytime and anywhere the patient needs it. The Mystique nebulizer is not intended for use with Pentamidine. It is intended for single patient use.

Mystique ultrasonic nebulizer