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The Mirage Echo channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system. The Mirage Echo is: to be used by adult patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.

The Mirage Echo provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face. Mirage Echo is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Mirage Echo is a prescription device supplied non-sterile.

The SomnoTraxx System is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information. It is intended for home use only in conjunction with ResMed S7 Elite and AutoSet Spirit CPAP Systems Positive Airway Pressure flow generators. SomnoTraxx System is not intended to provide automated treatment decisions nor to be used as a substitute for a competent healthcare professional's judgment. All patients' medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional. The S7 Elite and AutoSet Spirit CPAP Systems are indicated for the treatment of obstructive sleep apnea (OSA) in adult patients.

The S7™ Elite (K013909) and AutoSet® Spirit™ (K013843) CPAP Systems are microprocessor controlled blower-based systems that generate Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O as required to maintain an "air splint" for effective treatment of Obstructive Sleep Apnea (OSA). The system includes the flow generator, patient tubing and a mask (patient interface). For additional humidification, several humicifiers, including the integrated HuMDARE 2i, are designed to be compatible with the flow generators. AutoScan software allows viewing of flow-generator stored treatment data via a PC, transmitting the data using a direct connection or a modem. The SomnoTraxx™ System is designed to be used with ResMed's S7™ Elite and AutoSet Spirit™ CPAP The common raise " yetner retrieval and display of stored information from the flow generators to the clinician, via wireless transmission and web-based access. Access to the data is limited to subscribers of the system. There is no patient access to the system. The SomnoTraxx™ System is comprised of two distinct components, the ResTrax™ and the Server System. Data are extracted from the flow generator, transmitted via a wireless network, stored in a database, transmitted via the Internet and displayed for review by a healthcare provider. Both components must be present in order for the SomnoTraxx™ System to function. ResTrax™ ~ResTrax™ is an optional wireless module designed to attach to a ResMed S7™ Elite or AutoSet® Spirit™ flow generator using a docking mechanism allows the device to be electrically connected via the existing 15-pin expansion port located at the rear of the flow generator. When attached, the ResTrax™ can automatically collect usage and therapeutic information stored within the flow generator's memory. The ResTrax™ sends and receives information utilizing existing messaging networks providing wireless coverage to large portions of the US population. Server System – The Server System consists of several functional software modules that are designed to retrieve information from flow generators through the ResTrax™ and a wireless messaging network, store the information in a database and provide a secure interface into the system allowing users (not patients) to schedule information retrieval and view the results.

The AUTOSET SPIRIT CPAP System is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMDAIRE® 2[™) is indicated for the humidification and warming of air from the AUTOSET SPIRIT flow generator device. The AUTOSET SPIRIT CPAP System and HUMIDAIRE 2i are for home and hospital use.

The AUTOSET SPIRIT CPAP System is a non-invasive Continuous Positive Airway Pressure (CPAP) system. It includes the following system components: - Flow generator device, - . Humidifier - Mask and air tubing. - . Clinical Interface (AutoScan) Software. The flow generator device incorporates a blower (motor/fan assembly), sensors and processing electronics. The blower supplies pressurized air to the patient via the air tubing and a mask. The AUTOSET SPIRIT flow generator has two (2) modes of operation: - (i) CPAP Mode In this mode the flow generator provides a single fixed-pressure as set by the clinician. - Auto-titrating (AutoSet) Mode (ii) In this mode the pressure is automatically set in response to the patient's breathing patterns. The AutoScan software allows adjustment of parameter settings and viewing of flow generator-stored treatment data via a PC.

The S7™ ELITE CPAP System is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIRE® 21™) is indicated for the humidification and warming of air from the S7 Elite flow generator device. The S7 ELITE CPAP flow generator and HUMIDAIRE 21 are for home and hospital use.

The S7 ELITE CPAP SYSTEM is a non-invasive Continuous Positive Airway Pressure (CPAP) system, including the following system components: - Flow generator device - Integrated Humidifier (HUMIDAIRE 2i) - a Mask and air tubing - D Clinical Interface (AutoScan) Software The flow generator device incorporates a blower (motor/fan assembly), sensors and processing electronics. The blower supplies pressurized air to the patient via the air tubing and a mask. The S7 ELITE CPAP FLOW GENERATOR has one (1) mode of operation (CPAP fixed-pressure mode). In this mode the flow generator provides a single fixedpressure as set by the clinician. AutoScan software allows adjustment of parameter settings and viewing of flow generator-stored treatment data via a PC.

The SULLIVAN VPAP II ST-A System is intended to assist the ventilation of spontaneously breathing adult patients with respiratory insufficiency and/or obstructive sleep apnea. The patient is expected to have no more than minor and transient adverse effects if ventilation is not provided for extensive periods, for example overnight. The System is intended for patients who have adequate mental and physical capabilities, allowing them to quickly remove the mask in the case of system failure. The system is intended for use in the hospital or home.

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The HumidAire™ Heated Humidifier is indicated for the humidification and warming of the air from nasal Continuous Positive Airway Pressure (CPAP) and bi-level systems, but not autoset systems. The HumidAire is for prescription use only.

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