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The Inspiration® 7i / 5i Ventilator System is intended for use with patients having body weights in the range of 0.3kg to 200kg and Tidal Volumes of 5ml to 2000ml. The Inspiration® Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intrahospital transport. This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions. The intended patient population includes infant through adult patients who require pressurebased or volume-based continuous respiratory support with tidal volumes as low as 5 ml and inspiratory pressures as low as 1 cm H2O. The device is intended for use in hospital-type facilities, which provide respiratory care for patients requiring respiratory support. The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel.

The Inspiration™ 71 / 51 Ventilator System provides continuous ventilation to patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration™ Ventilator System (K072950), with the following additions: - . a GUI change to deliver a GUI similar to that of the eVolution ventilator. - Additional monitored and trended parameters. . - . Additional waveforms and loops. - Additional medium and high priority alarms. . - . Additional patient setup and default setting criteria. - . : Integration of SNMP fields for settings, monitored and trended data. - . Integration of Volumetric and Sidestream Capnography capability (7i model only) The capnography addition will require specific adaptors and sensors to allow use of this feature. - Integration of various maneuvers

The Inspiration™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.

The Inspiration™ Ventilator System provides continuous ventilation to patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration™ Ventilator System, with the addition of the capability to set tidal volumes in volume targeted modes down to 5 ml, while 10 ml is the lower limit on the cleared device. This modification is implemented on the Inspiration™ Ventilator through additional functionality in software only. The existing modalities, pneumatic design, breath delivery control algorithms, electrical circuitry and user interface mechanism have remained unchanged from the cleared Inspiration™ ventilator device.

The Independence™ Medical Air Compressor is indicated for use as a Medical Air Compressor providing compressed air to ventilators.

The Independence™ Medical Air Compressor is a Class II device, "Portable Air Compressor'', per 21 CFR Part 868.6250. This device is designated a Class I. Type B equipment per IEC 60601-1. The Independence™ Medical Air Compressor is an air compressor for use in intensive care units or the recovery rooms of clinics, hospitals and hospital-type facilities which delivers filtered, oil-free and dehumidified compressed air to ventilators. Using the integrated backup function, the Independence™ Medical Air Compressor can be connected between an existing air supply network and a ventilator. If the compressed air from the air supply network fails, the Independence™ Medical Air Compressor automatically starts and supplies compressed air to the ventilator.

The Inspiration ™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.

The Inspiration™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options provides continuous ventilation to patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration™ Ventilator System, with the addition of two new software options: 1) The Smart Positive Airway Pressure (SPAP) modification provides the Inspiration™ Ventilator System with a biphasic pressure mode that allows for spontaneous breathing at two separate PEEP baselines. 2) The Volume Targeted Ventilation (VTV) modification provides the Inspiration™ Ventilator System with a pressure based breath mode that targets tidal volume by adjusting the delivered pressure targets on a breath-to-breath basis. This modification includes Pressure Regulated Volume Control (PRVC) and Volume Support (VS). This option also includes Automode which allows patients the backup safety support of mandatory breaths if they stop breathing and transition back to their spontaneous mode when they are again breathing spontaneously. These modifications are implemented on the Inspiration™ Ventilator through additional functionality in software only. The existing modalities, pneumatic design, breath delivery control algorithms, electrical circuitry and user interface have remained unchanged from the cleared Inspiration™ ventilator device.

The InspirationTM Ventilator System is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.

The Inspiration™ Ventilator System is housed in a metallic enclosure, comprising clear anodized aluminum with painted finish and is mounted on a mobile stand. User controls and display screen are located on the front face of the Ventilator. Display and controls operation is described in the Ventilator Settings and Controls section of the User Manual (See Section 14 of this Submission). Ventilation parameters are programmed by the operator, using the function and navigation keys plus the Push & Turn control device on the Ventilator front panel, in conjunction with selectable display screens. The programmed data from the User Interface is processed by the main microprocessor and stored in ventilator non-volatile memory. The microprocessor uses the stored data in the control of breath delivery. Oxygen and air supply connections are located on the back of the Ventilator. The patient breathing circuit connection is located below the front face of the unit, together with a pneumatic outlet for driving an optional accessory jet nebulizer. The Ventilator stand serves to support the main Ventilator unit, breathing circuit tubing and accessory equipment, facilitating connection to the Ventilator. The Inspirations Ventilator System incorporates three communications interfaces, namely, a Nurse Call interface, an RS-232 and an Ethernet interface. The Nurse Call interface comprises normally open and normally closed relay contacts (changeover switch) acting simultaneously with an alarm condition. Both the RS232 and Ethernet interfaces enable the same data transmission to receiving terminals such as nurse and physician workstations and PC equipment. The Inspiration ... Ventilator System consists of two major systems, the pneumatic system and the electrical/electronic system, which combine under software control to deliver respiratory support at operator-determined parameters. The pneumatic system, under microprocessor control, supplies air and oxygen to the patient system, external to the device. The electricallelectronic system inputs and supervises one of three alternative power sources to the unit and provides electronic control of the ventilator's pneumatic system components. The Inspiration™ Ventilator System can operate with a range of standard ventilator accessories, such as breathing circuits, nebulizer and humidifier.