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The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 5kg (11 lb) who require mechanical ventilation. The iVAPS mode is intended for patients weighing more than 66lb (30kg). The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and non-invasive ventilation.

The Astral ventilator system uses a micro-processor controlled blower, which, along with valves and pressure and flow sensors, achieves pressure, flow and time regulation of air is directed to the patient via one of three ventilator breathing circuit, single circuit with expiratory valve, or single circuit with intentional leak. Supplemental oxygen can be entrained at the main turbine. The device provides both therapeutic alarms (e.g. tidal volume) and technical alarms (e.g. system fault), and a user interface allowing adjustment of clinical parameters and display of monitored clinical data. The Astral can use external AC or DC power supply and contains an integrated battery. The Astral is capable of providing the following types of ventilatory support: - -Assist/Control and SIMV with either volume or pressure control - -Continuous Spontaneous Ventilation in either Pressure Support or CPAP - -Volume Assurance and Apnea Ventilation

The AirFit F20 is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous pressure (CPAP) or bilevel system. The AirFit F20 is: • to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed • intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment.

The AirFit F20 is an externally placed vented mask covering the mouth and the nose of the patient. It provides a seal such that pressure from a positive pressure source is directed to the patient's nose and/or mouth. The mask connects via a standard conical connector to a conventional air delivery hose, which in turn connects to the positive pressure source. The mask is held in place with an adjustable headgear that straps the mask to the face. The AirFit F20 mask system comprises four subassemblies: cushion, frame, elbow and headgear. The elbow incorporates the vent array and anti-asphyxia valve safety features. The cushion and headgear are available in various sizes to fit a wide patient population. AirFit F20 is a prescription device supplied non-sterile.

AirView is a web based solution for healthcare specialists intended to: - assist in the diagnosis of sleep disordered breathing in adult patients through analysis of data recorded by an AirView compatible home sleep device. - transfer and display machine and therapeutic information that has been transmitted remotely from the patient's therapy device. It is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed therapy device. AirView also provides remote settings capabilities for non-life support devices only.

AirView is a web application that can transfer, store, analyse, manage, and display machine and therapy data (from ResMed compatible therapy devices) and diagnostic data (from ResMed compatible sleep study devices). The data is transferred from the device either wirelessly through a communications module or with the aid of a data card/USB stick and internet technology to a central database and then displayed on the healthcare professional's computer through a web browser such as Internet Explorer. The software application enables patient machine and therapy data to be shared across several different user groups for the primary purpose of monitoring patient compliance and home sleep studies. Clinical users and other healthcare specialists can access data with ResMed approved user accounts. AirView can also be used by the healthcare specialist to remotely change the machine settings of compatible therapy devices. This assists in addressing any clinical issues in a timely manner and providing the necessary patient support. This is restricted to non-life support therapy devices only.

The Darlinghurst Vented mask is a non-invasive accessory used for channeling airflow to a patient from positive airway pressure (PAP) devices. The mask is: - to be used on patients weighing >66 lb (30 kg), for whom non-invasive positive airway pressure therapy has been prescribed - disposable devices, intended for short-term treatment (up to 7 days) of a single patient, in the hospital environment only. The Darlinghurst NV-AAV mask is a non-invasive accessory used for channeling airflow to a patient from a positive airway pressure (PAP) device. The mask is: - to be used on patients weighing >66 lb (30 kg), for whom non-invasive positive airway pressure ● therapy has been prescribed - a disposable device, intended for short-term treatment (up to 7 days) of a single patient, in the ● hospital environment only - intended to be used with breathing circuits or positive pressure ventilation (PPV) devices that provide their own method of venting expired or supplemental gases.

The Darlinghurst masks are externally placed masks covering the mouth and the nose of the patient. They provide a seal such that positive pressure from a positive pressure source is directed to the patient's nose and/or mouth. The masks connect via a standard (female ISO5356-1) conical connector to a conventional air delivery hose between the mask elbow and the positive airway-pressure source. They are held in place with a common adjustable headgear that straps the mask to the face. Darlinghurst masks are disposable devices that can be used for a maximum period of 7 days, on a single-patient and in the hospital/institutional environment only. Both Darlinghurstmask variants are very similar in design and function. The only difference between the Darlinghurst 'Vented' and the Darlinghurst 'NV-AAV' is in the elbow component. Whilst both variants of the mask include a built-in Anti-Asphyxia Valve (AAV) to allow the patient to continue to breathe fresh air in the event of a positive air-pressure supply failure or impediment, - . The Darlinghurst Vented mask includes additional built-in diffuse exhaust ports to provide a continuous air leak that flushes out CO2 and prevent it from being rebreathed by the patient - The Darlinghurst NV-AAV design does not incorporate built-in passive exhaust ● ports. This non-vented variant of the mask requires a separate part of the breathing circuit (e.g. an active exhaust valve in the ventilator or an additional leak valve) to vent the expired air (including CO2). All other components of the masks are common to both Darlinghurst variants. Darlinghurst masks are intended to be used under the conditions and purposes indicated in the labelling provided with the product. Darlinghurst masks are prescription devices, supplied non-sterile.

The S9 Greenhills is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep annea (OSA), central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use. The hunidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.

The S9 Greenhills is similar to the predicate device(s), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is identical to the S9 VPAP Adapt (K113801) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmH2O. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier. The S9 Greenhills is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV mode) or (ASVAuto mode) to stabilize a patient's ventilation during sleep. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average minute ventilation. It then adjusts the degree of pressure support to servo-control the patilation to at least equal the target ventilation. The same is true for ASVAuto mode except the EPAP is adjusted to address any obstructive apneas detected. Therapy modes contained in the S9 Greenhills are CPAP, ASV, and ASVAuto and unchanged from the S9 VPAP Adapt (K102586). They are: - . CPAP mode - the device delivers a continuous positive airway pressure throughout the entire therapy session; - ASV mode the device automatically adjusts pressure support in response to the . patient's recent average minute ventilation; and - ASVAuto mode the device automatically adjusts pressure support in response to . the patient's recent average minute ventilation and EPAP level for OSA events. The functional characteristics of the S9 Greenhills system includes all the clinician and user friendly features of the predicate device which have been verified during usability studies in accordance with IEC 62366 Medical devices - Application of usability engineering to medical devices.

The S9 WANDA VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). It is intended for use in the hospital and home.

S9 WANDA VPAP ST System is similar to the predicate device (S9 VPAP ST (K102513)). Key features include: inline power supply; integrated humidifier; tubing; colour LCD; and simple controls. The S9 WANDA VPAP ST contains a Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 3-25 cmHzO as required to maintain an "air splint" for treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier. The S9 WANDA VPAP ST flow generator includes the same therapy modes as the S9 VPAP ST system (K102513) predicate device. These base therapy modes include: CPAP and CPAP with expiratory pressure relief (EPR) modes the device delivers a continuous positive airway pressure throughout the therapy session Bilevel mode the flow generator augments any breath initiated by the patient by detecting the onset of inspiration or expiration and delivering the set Inspiratory Positive Airway Pressure (IPAP) and Expiratory Positive Airway Pressure (EPAP) VAuto mode - the mean air-way pressure (between IPAP and EPAP) will alter based upon breathing events The functional characteristics of the S9 WANDA VPAP ST system includes all the clinician and user friendly features of the predicate device which have been verified during usability studies in accordance with IEC 62366 Medical devices - Application of usability engineering to medical devices.

The AirSoft F15 is a noninvasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as continuous positive airway pressure (CPAP) or bilevel system. The AirSoft F15 is: • to be used by patients (weighing >66 lb (30 kg)) for whom positive airway pressure therapy has been prescribed • intended for single-patient reuse in the home environment and multipatient reuse in the hospital/institutional environment.

The AirSoft F15 Mask system is an externally placed mask covering the mouth and the nose of the patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose and/or mouth. It is held in place with an adjustable headgear that straps the mask to the face. AirSoft F15 can be cleaned by the patient in the home environment and reprocessed by professionals in the hospital/institutional environment. AirSoft F15 is intended to be used under the conditions and purposes indicated in the labelling provided with the product. AirSoft F15 is a prescription device supplied non-sterile.

The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 5kg (11 lb) who require mechanical ventilation. The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and non-invasive ventilation.

The Astral ventilator system uses a micro-processor controlled blower, which, along with valves and pressure and flow sensors, achieves pressure, flow and time regulation of air delivery. Air is directed to the patient via one of three ventilator breathing circuits; double circuit, single circuit with expiratory valve, or single circuit with intentional leak. Supplemental oxygen can be entrained at the inlet to the main turbine. The device provides both therapeutic and technical alarms, and a user interface allowing adjustment of clinical parameters and display of monitored clinical data. The Astral can use external AC or DC power supply and contains an integrated battery. The Astral is capable of providing the following types of ventilatory support: - Assist/Control and SIMV with either volume or pressure control - Continuous Spontaneous Ventilation in either Pressure Support or CPAP - Volume Assurance and Apnea Ventilation

The S9 Cronulla for Her self-adjusting system is indicated for the treatment of mild to moderate obstructive sleep apnea (OSA) in female patients weighing more than 66 lb (30 kg). The S9 Cronulla for Her self-adjusting system is intended for home and hospital use.

The 'S9 Cronulla for Her' contains a Micro-processor controlled blower (flow generator) system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing (standard, or heated), mask (patient interface) and humidifier. The 'S9 Cronulla for Her' System (S9 Cronulla for Her with HumidAire 5i) retains all the same hardware and performance features of the predicate device. Key features include in-line power supply, HumidAire 5i, tubing (heated and standard options) and colour LCD for better user interface. The 'S9 Cronulla for Her' flow generator includes three therapy modes. These include: - CPAP mode - the device delivers a continuous positive airway pressure throughout the entire therapy session - AutoSet mode the device automatically adjusts pressure in response to inspiratory flow limitation, snore and apnea. - AutoSet for Her mode -- the device automatically adjusts pressure in response female-specific OSA characteristics. The functional characteristics of the S9 Cronulla for Her system includes all the clinician and user friendly features of the predicate device which have been verified during usability studies in accordance with IEC 62366 Medical devices - Application of usability engineering to medical devices.

The AirFit™ N10 channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device. The AirFit™ N10 is: to be used by 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 AirFit™ N10 is an externally worn mask that provides an air seal, such that air flow from a positive pressure source is directed to the patient's nose. The mask is held in place with an adjustable headgear. It connects to a conventional PAP device air delivery hose via a standard 22mm swivel. The mask may be cleaned with mild soap. continuous air leak to prevent rebreathing of dead space CO2 AirFit™ N10 is a prescription device supplied non-sterile.