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Medium and Large Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>30 kg) who are appropriate candidates for noninvasive ventilation. Small Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>20 kg) who are appropriate candidates for noninvasive ventilation.

The AF531 Oro-Nasal SE Face Mask is designed for single-patient use in the hospital or institutional environment. AF531 Oro-Nasal SE Face Mask covers the nose and mouth while avoiding the eye region. The mask is available in three (3) sizes: Small, Medium, and Large. The headgear options for the AF531 Oro-Nasal Masks include the four-point headgear and a CapStrap headgear. The AF531 Oro-Nasal SE Face Mask requires use of a separate exhalation device. The mask utilizes a click-style elbow that secures to the mask hub yet can be removed by pressing the release tabs.

This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients >7 years old (>40 lbs) for whom CPAP or bi-level therapy has been prescribed.

The Therapy Mask 3100 NC/SP consists of a minimal contact nasal mask cushion/SP: silicone pillows cushion), a two-point headgear, and a mask frame with exhalation port. The mask frame contains enclosed magnets and connects to the nasal mask cushion (NC/SP) magnetically for easy and secure assembly/disassembly by the user. The nasal mask cushion enclosed magnets and the mask frame enclosed magnets are of opposite polarity to prevent incorrect assembly of the mask. The Therapy Mask 3100 NC/SP has a pig tail tube in front mask. The nasal cushion seals around the bottom of the patient's nose. Nasal cushion (NC) has five sizes: extra small (XS), small (S), medium (M), medium wide (MW), and large (L). The silicone pillows cushion tips seal at the entrance to the nares and the pillows cushion base sits under the silicone pillows cushion (SP) has five sizes: extra small (XS), small (S), medium (M), medium wide (MW), large (L). The headgear has one size and includes adjustment sliders to allow for a large or small fitting on the patient's head. The mask frame is one size and connects to the mask frame connects to the mask cushion magnetically for easy and secure assembly/disassembly by the user. The Therapy Mask 3100 NC/SP has a 10 mm pig tail tube in front mask. The 10 mm pig tail tubing contains built-in exhalation at the top of the tube where the pig tail tubing connects to the pig tail tubing will also include an ISO 5356-1 compliant, 22 mm male conical swivel connector. The male connector will connector will connect directly to ISO 5356-1 compliant, 22 mm female connector used on therapy device tubing. The male conical swivel connector is detachable from the pig tail tubing, via a quick disconnect feature. When the male concector is detached, the pig tail tubing connects to 12 mm therapy device tubing directly. The Therapy Mask 3100 NC/SP is designed to be easily disassembled for cleaning or replacement purposes. The components may be cleaned by the patient in the home (single patient - multiple use) or cleaned and disinfected by the professional in the hospital/institutional environment (multiple patient – multiple use).

Care Orchestrator Essence is intended for use by healthcare professionals (e.g., Physicians, Durable Medical Equipment providers) to gather, store, manage, and view compliance data for patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. The software also includes the ability to create new or updated prescriptions and/or performance settings, store them, and transmit them to compatible Respironics' non-life supporting therapy devices and Respironics Trilogy ventilator. Data and prescription settings are transferred between Care Orchestrator Essence and compatible devices via removable media. Care Orchestrator Essence is intended to be used in hospital, institutional, provider, and home care settings by healthcare representatives. The software does not perform automatic scoring or diagnosis. The data it provides are only one of several elements to consider when making decisions about patient therapy.

Care Orchestrator Essence software is a desktop solution that allows healthcare representatives (e.g., physicians, clinicians, durable medical equipment providers) involved in a patient's therapy lifecycle the ability to manage patients and referrals; control access to patient information; view and interact with therapy and prescription data from Respironics devices; enhance the patient compliance management workflow; and gain efficiencies in the overall patient therapy workflow. Care Orchestrator Essence supports patient data management and prescription updates for sleep therapy devices (BZD, MNS, MNT) and Trilogy respiratory devices (CBK, NOU) through an SD card.

The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional, home, and non-emergency transport settings for example wheelchair or personal vehicle. It may be used for both invasive and non-invasive ventilation.

The Trilogy Evo ventilator is a microprocessor controlled blower based pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation. The ventilator is intended to provide continuous or intermittent ventilatory support. The ventilator is suitable for use in institutional, home, and non-emergency transport settings for example wheelchair or personal vehicle. It is applicable for adults and pediatric patients weighing at least 2.5 kg who require the following types of ventilatory support: Control Modes (A/C-PC, A/C-VC), Spontaneous modes (CPAP, PSV), Mixed modes (S/T, SIMV-PC, SIMV-VC), AVAPS-AE modes (AVAPS-AE with PC Breath enabled, with auto backup; AVAPS-AE with PC Breath enabled, without auto backup; AVAPS-AE with PC Breath disabled, with auto backup; AVAPS-AE with PC Breath disabled, without auto backup). In addition to the therapy modes, the Trilogy Evo provides the following major functions: Therapy Features, Power Manaqement, Physiological alarms, Graphical User Interface using a touch screen display, status LEDs and dedicated keys for user input, Bluetooth and USB Communications, Compatibility with various patient interfaces and multiple circuit types, Remote alarm and nurse call capability, Connectivity with hospital monitors, Capability to connect, display and alarm SpO2, FiO2 and ETCO2 monitors, Ventilation with supplemental low flow oxygen or oxygen blender.

The Trilogy Evo Universal ventilator provides continuous or intermittent pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediativ through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional/hospital settings and non-emergency transport settings for example wheelchair. It may be used for both invasive ventilation.

The Trilogy Evo Universal ventilator is a microprocessor controlled blower based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation. The ventilator is intended to provide continuous or intermittent ventilatory support. The ventilator is suitable for use in institutional/hospital settings and non-emergency transport settings for example wheelchair. It is applicable for adults and pediatric patients weighing at least 2.5 kg who require the following types of ventilatory support: Control Modes - A/C-PC: Assist control . - . A/C-VC: Assist control Spontaneous modes - CPAP: Continuous positive airway pressure . - PSV: Pressure support ventilation . Mixed modes - S/T: Spontaneous/timed ventilation . - . SIMV-PC: Synchronized intermittent mandatory ventilation (pressure control) - SIMV-VC: Synchronized intermittent mandatory ventilation (volume control) In addition to the therapy modes, the Trilogy Evo Universal provides the following major functions: - Therapy Features including Backup Ventilation, Inspiratory Time Min/Max and Sigh ● - Power Management of various power sources (AC, internal and detachable Li-lon batteries and ● external Pb-Acid battery) - Physiological alarms - . Graphical User Interface using a touch screen display, status LEDs and dedicated keys for user input - . Bluetooth and USB Communications - Compatibility with various patient interfaces and multiple circuit types - Connectivity with hospital monitors ● - . Capability to connect, display and alarm SpO2, FiO2 and ETCO2 monitors - . Ventilation with supplemental low flow oxygen or oxygen blender The associated accessories include: - Bacteria Filter ● - Circuits, including Passive, Active and Dual Limb - FiO2 Sensor ● - . Active Exhalation Valves - . Leak Device - . Heat and Moisture Exchangers (HME's) - Oximeter and Sensors - Capnography Sensors and cable ● - Flow Sensors - Detachable Battery and Battery Cables ● - Roll Stand - Mounting Bracket .

Care Orchestrator is intended to support clinicians by tracking data on patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. Care Orchestrator provides remote patient data collection & viewing and is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in conjunction with compatible non-life support therapy devices to adjust prescription and/ or performance settings. Care Orchestrator allows read-only access to patients. Care Orchestrator is intended to be used in hospital, institutional, provider, and home care settings.

Care Orchestrator is a solution that will provide entities involved in a patient's therapy lifecycle with the ability to manage patients and referrals, control access to patient information and theract with billing information, enhance patient compliance management workflow, manage the resupply of medical equipment, and gain efficiencies in the overall Patient Therapy Workflow. Care Orchestrator will support patient data management for sleep therapy devices (BZD, MNS, MNT) and respiratory devices (CBK, NOU, CAW). Care Orchestrator will support prescription updates for sleep therapy devices. There are no input flows to the respiratory device interfaces (Bluetooth and SD Card). Device prescription and settings are read-only for these respiratory device types.

Sapphire is intended to support clinicians by tracking data on patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. Sapphire provides remote patient data collection & viewing and is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in conjunction with compatible non-life support therapy devices to adjust prescription and/or performance settings. Sapphire allows read-only access to patients. Sapphire is intended to be used in hospital, institutional, provider, and home care settings.

Sapphire is a web application that is used to manage patients utilizing compatible sleep and respiratory devices, view therapy data, generate reports and update device settings for applicable therapy devices. Sapphire is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in hospital, institutional, provider and home settings. Device data is transferred either wirelessly or from an SD card to a centralized database. A user can view this data through a web based application on their computer.

The Revolution Full Face Mask is intended to provide an interface for continuous possitive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospital/institutional environment. The mask is to be used by patients greater than 66lbs/30kg.

The Respironics Revolution Full Face Mask consists of a frame (faceplate) with a silicone cushion and an elbow with an integral entrainment valve. The faceplate holds multiple sizes in order to exchange mask cushion sizes on one (frame) faceplate. The Revolution Full Face Mask cushion has eight exhalation vents, with four vents located on either side of the mask cushion. As a result, a separate exhalation device is not required for use of this mask. The mask has an integrated entrainment valve elbow with a two-piece polycarbonate valve body with a silicone flapper and exhalation vents located on the valve body. This feature was modified from Revolution Full Face (K082866) from a "stream-line" design however this elbow design was cleared under K073600. The design of the Revolution Full Face Mask headgear has two slide-through top strap adjustments, side and back straps, a Lower Headgear Band and a Chin Support Band. The mask is available in four sizes – small, medium, and large.

The Kangaroo Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 Ibs /30 kg.

The Kangaroo Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. It provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned by the patient in the home (single patient use) or cleaned by the professional in the hospital/institutional environment through high-level disinfection processes (multi-patient use). The Kangaroo Nasal Mask consists of a frame with a gel cushion is designed in such a way that it minimizes leaks and is comfortable for the patient. An elbow is connected to the cushion and includes integrated exhalation features. The elbow can rotate freely through 360 degrees and is connected to 15 mm tubing that includes an integrated 22 mm swivel connector. The mask is designed in such a way that it can be easily disassembled for cleaning or to replace several of the mask components. The 22 mm swivel connector on the 15 mm tubing is used to connect the mask to a conventional 22 mm air delivery hose that is in turn connected to the positive airway pressure source. The swivel connector can rotate freely through 360 degrees.

The Simple T Nasal Mask is intended to provide an interface for continuous positive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospitallinstitutional environment. The mask is to be used by patients greater than 66lbs/30kg.

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